DERR-2025-004765

Cover Page
Quality Assurance Project Plan
The Other Side Village Phase 2
Redwood Road Dump
VCP Site C136
Salt Lake City, Utah
June 20, 2025
Terracon Project No. 61257031
Prepared for:
The Other Side Academy and Salt Lake City Corporation
Salt Lake City, Utah
Facilities | Environmental | Geotechnical | Materials 1
Group A Project Management
A1 Title and Approval Sheet
Project Title:
The Other Side Village Phase 2 Project Quality Assurance
Project Plan
VCP Site #C136
Salt Lake City, Utah
Terracon Consultant Project Manager
Signature Date
Jill Hernandez, PE
Printed Name
Terracon Consultant QA/QC Officer
Signature Date
Andrew S. Turner, PG
Printed Name
Terracon Consultant Authorized Project Reviewer
Signature Date
Amy Austin
Printed Name
06/20/2025
06/20/2025
Amy Austin 06/20/2025
Quality Assurance Project Plan
The Other Side Village Phase 2 | Salt Lake City, Utah
June 20, 2025 | Terracon Project No. 61257031
Facilities | Environmental | Geotechnical | Materials 2
A2 Table of Contents
Group A Project Management ................................................................ 1
A1 Title and Approval Sheet ......................................................................... 1
A2 Table of Contents ................................................................................... 2
A2.1 Acronym List ............................................................................... 4
A3 Distribution List...................................................................................... 6
A4 Project/Task Organization ....................................................................... 7
A5 Problem Definition/Background .............................................................. 10
A6 Project/Task Description and Schedule .................................................... 11
A7 Quality Objectives and Criteria for Measurement Data .............................. 12
A7.1 Data Quality Objectives ............................................................... 12
A7.2 Measurement Performance Criteria ............................................... 12
A8 Special Training Requirements ............................................................... 15
A9 Documentation and Records .................................................................. 15
Group B Measurement/Data Acquisition ................................................. 17
B1 Sampling Process Design....................................................................... 17
B2 Sampling Methods Requirements ........................................................... 17
B3 Sample Handling, Preservation, and Custody Requirements ....................... 18
B4 Analytical Methods Requirements ........................................................... 18
B5 Quality Control Requirements ................................................................ 19
B5.1 Definitive Data ........................................................................... 19
B5.2 Non-definitive data ..................................................................... 22
B6 Equipment Testing, Inspection, and Maintenance Requirements ................. 22
B7 Instrument/Equipment Calibration and Frequency .................................... 22
B7.1 Field Instruments ....................................................................... 22
B7.2 Laboratory Instruments .............................................................. 23
B8 Inspection/Acceptance Requirements for Supplies and Consumables .......... 23
B9 Data Acquisition of Non-direct Measurements .......................................... 24
B10 Data Management ................................................................................ 24
Group C Assessment/Oversight ........................................................ 25
C1 Assessment Activities ........................................................................... 25
C2 Reports to Management ........................................................................ 25
Group D Data Validation And Usability ............................................... 26
Quality Assurance Project Plan
The Other Side Village Phase 2 | Salt Lake City, Utah
June 20, 2025 | Terracon Project No. 61257031
Facilities | Environmental | Geotechnical | Materials 3
D1 Data Review ........................................................................................ 26
D2 Validation and Verification Methods ........................................................ 26
D3 Reconciliation with User Requirements .................................................... 27
Group E References ........................................................................ 27
Exhibit
Exhibit 1:TOSV Phase 2 Boundary
Exhibit 2:Organization Plan
Tables
Table 1:Data Quality Indicators
Table 2:Method Summary
Table 3:Data Validation and Verification Methods
Appendices
Appendix A: Laboratory Quality Assurance Manuals
Appendix B: Standard Operating Procedures
Appendix C: PFAS Sampling Guides
Quality Assurance Project Plan
The Other Side Village Phase 2 | Salt Lake City, Utah
June 20, 2025 | Terracon Project No. 61257031
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A2.1 Acronym List
ACBM
BAP
bgs
CERCLA
COCs
Asbestos Containing Building Materials
Benzo(a)pyrene
Below Ground Surface
Comprehensive Environmental Response, Compensation, and Liability Act,
as Amended
Contaminants of Concern
DERR Division of Environmental Response and Remediation
DL laboratory reporting limit a.k.a. practicable quantification limit
DQI Data Quality Indicators
DQO Data Quality Objectives
EDD Electronic Data Deliverable
ESA Environmental Site Assessment
ESC
GC/MS
ESC Laboratories
Gas Chromatography/Mass Spectrometry
HASP
HAZWOPER
Health and Safety Plan
Hazardous Waste Operations and Emergency Response
LCS
LCSD
LEL
Laboratory Control Sample
Laboratory Control Sample Duplicate
Lower Explosive Limit
LFB Laboratory Fortified Blank
LIMS Laboratory Information Management System
MCL
MDL
Maximum Contaminant Level
Method Detection Limit
mg/kg Milligrams per Kilogram (or parts per million)
mg/L Milligrams per Liter (or parts per million)
µg/kg Micrograms per Kilogram (or parts per billion)
µg/L
MPCA
Micrograms per Liter (or parts per billion)
Minnesota Pollution Control Agency
MS Matrix Spike
MSD Matrix Spike Duplicate
NELAP
NIST
National Environmental Laboratory Accreditation Program
National Institute of Standards and Technology
OSHA
PAH
Occupational Safety and Health Act
Polynuclear Aromatic Hydrocarbon
PARCCS
PCB
PFAS
PFOA
PFOS
Precision, Accuracy, Representativeness, Completeness, Comparability, and
Sensitivity
Polychlorinated Biphenyl
Perfluoroalkyl and Polyfluoroalkyl Substances
Perfluorooctanoic Acid
Perfluorooctanesulfonic Acid
Quality Assurance Project Plan
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ppb Parts per Billion (µg/kg or µg/L)
ppm
ppmv
Parts per Million (mg/kg or mg/L)
Parts per Million by volume
PR Percent Recovery
PS Performance Standard
QA
QAM
Quality Assurance
Quality Assurance Manual
QAPP Quality Assurance Project Plan
QC
RDL
RPD
Quality Control
Laboratory Reporting Detection Limit
Relative Percent Difference
RSL Regional Screening Level
SAP
SOP
Sampling and Analysis Plan
Standard Operating Procedure
SLCC
SVOC
Salt Lake City Corporation
Semi-volatile Organic Compounds
TOC
TOSV
Table of Contents
The Other Side Village
UDEQ Utah Department of Environmental Quality
US EPA
UST
VISL
VOC
VCP
United States Environmental Protection Agency
Underground Storage Tank
Vapor Intrusion Screening Level
Volatile Organic Compounds
Voluntary Cleanup Program
Quality Assurance Project Plan
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A3 Distribution List
Catherine Wyffels
Air Quality & Environmental Program Manager
Salt Lake City Corporation, Department of Sustainability
451 South State Street, Room 148
Salt Lake City, UT 84115-5470
[phone]
Email: [e-mail]
Tim Stay
Chief Executive Officer
The Other Side Academy
667 East 100 South
Salt Lake City UT 84102
[phone]
Email: [e-mail]
Allison Stanley
Project Manager, Voluntary Cleanup Program (VCP)/Brownfields Section
Utah Department of Environmental Quality
P.O. Box 144840
Salt Lake City, UT 84114-4840
[phone]
Email: [e-mail]
Jill Hernandez, P.E.
Consultant Project Manager
Terracon Consultants, Inc.
6952 South High Tech Drive, Suite B
Midvale, UT 84047
Phone: [phone]
Email: [e-mail]
Andrew Turner, P.G.
Consultant QA/QC Officer
Terracon Consultants, Inc.
6949 South High Tech Drive
Midvale, UT 84047
Phone: [phone]
Email: [e-mail]
Quality Assurance Project Plan
The Other Side Village Phase 2 | Salt Lake City, Utah
June 20, 2025 | Terracon Project No. 61257031
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A4 Project/Task Organization
This Quality Assurance Project Plan (QAPP) provides guidelines for the acquisition, analysis,
and validation of data collected for The Other Side Village (TOSV) Phase 2 Project at the
Redwood Road Dump Comprehensive Environmental Response, Compensation, and Liability
Act (CERCLA) facility. The property has been enrolled in the Utah Department of
Environmental Quality (UDEQ) Voluntary Cleanup Program (VCP) as VCP Site #C136. The
following is a brief description and identification of key personnel involved in conducting
investigations at this site.
The Other Side Academy Project Manager
The Other Side Academy (TOSA) is the primary VCP Applicant and will develop the property.
The development Project Manager is the central point of contact approving VCP activities
and problem resolution and is the primary point of contact with the Consultant Project
Manager regarding administrative and technical issues associated with this project. The
TOSA Project Manager for this project is:
Tim Stay, CEO
The Other Side Academy
667 East 100 South
Salt Lake City, UT 84102
[phone]
Email: [e-mail]
Salt Lake City Corporation Project Manager
The Salt Lake City Corporation (SLCC) owns the property. The Owner’s Project Manager is
the central point of contact approving VCP activities and problem resolution and is the
primary point of contact with the Consultant Project Manager regarding administrative and
technical issues associated with this project. The Owner’s Project Manager for this project
is:
Catherine Wyffels, Air Quality & Environmental Program Manager
Salt Lake City Corporation, Department of Sustainability
451 South State Street, Room 148
Salt Lake City, UT 84115-5470
[phone]
Email: [e-mail]
Consultant Project Manager
The Consultant Project Manager is the central point of contact directing VCP activities and
problem resolution and will have responsibility for overseeing the activities associated with
Quality Assurance Project Plan
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the sampling activities. This person will be in direct contact with the Owner’s Project
Manager and with the UDEQ Project Manager. This person will be responsible for the
preparation and maintenance of the QAPP, for distribution of the most current version of the
QAPP to the individuals identified in the Distribution List, preparing and/or overseeing
preparation of Site Characterization Work Plans for individual investigations, and for overall
management of the field investigation portion of the project. The Consultant Project
Manager will coordinate closely with the Consultant Quality Assurance/Quality Control
(QA/QC) Officer and provide oversight during the field activities with routine visits to the
jobsite(s). Additional responsibilities include scheduling, subcontractor procurement, cost
accounting and reporting, identification of potential problems and development of
contingency plans to respond to the identified problems. The Consultant Project Manager for
this project is:
Jill Hernandez, P.E., Consultant Project Manager
Terracon Consultants, Inc.
6952 South High Tech Drive, Suite B
Midvale, UT 84047
Phone: [phone]
Email: [e-mail]
Consultant QA/QC Officer
The Consultant QA/QC Officer for this project will function as an independent advisor to the
Consultant Project Manager and will oversee project activities as necessary. This role will
include providing surveillance level oversight, laboratory performance evaluation, and data
quality validation with QA/QC reviews of all data included in final reports. The Consultant
QA/QC Officer for this project is:
Andrew Turner, P.G., Consultant QA/QC Officer
Terracon Consultants, Inc.
6949 South High Tech Drive
Midvale, UT 84047
Phone: [phone]
Email: [e-mail]
UDEQ Project Manager
The UDEQ Project Manager will assist and support the review of the QAPP, SAPs, and other
reports generated under the VCP project. The UDEQ will remain a technical resource for the
field activities and reporting throughout the course of the project. The UDEQ Project
Manager for this project is:
Allison Stanley, Project Manager, VCP/Brownfields Section
Utah Department of Environmental Quality
Quality Assurance Project Plan
The Other Side Village Phase 2 | Salt Lake City, Utah
June 20, 2025 | Terracon Project No. 61257031
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P.O. Box 144840
Salt Lake City, UT 84114-4840
[phone]
Email: [e-mail]
Environmental Laboratories:
Pace Analytical, Chemtech-Ford Analytical Laboratories, Eurofins EMLab P&K Analytical
Testing Laboratories, and H&P Mobile Geochemistry, Inc.
It is expected that the majority samples of environmental media that are collected during
the investigations will be analyzed by Pace Analytical. Pace Analytical is an environmental
analytical firm providing technical and support services to customers nationwide, with a
diverse accreditation/certification program which represents over 48 separate state and
national accreditations. Pace Analytical is responsible for providing reliable and high-quality
analytical data, using the quality systems detailed in its Quality Assurance Manual
(Appendix A). The Quality Assurance Director for Pace Analytical is responsible for managing
the implementation, monitoring, and development of the laboratory’s Quality Assurance
Systems as well as overseeing laboratory safety, waste management, internal and external
audits, and new method implementation. The Environmental Laboratory and Quality
Assurance Director is:
Blake Judge, Laboratory Quality Assurance Director
Pace Analytical
12065 Lebanon Road
Mt. Juliet, Tennessee 37122
[phone]
[e-mail]
Due to laboratory availability, additional needed specialty analyses, requested expediated
turnaround times, etc., environmental samples collected may also be analyzed by
Chemtech-Ford Analytical Laboratories (Chemtech-Ford). Located in Sandy, Utah,
Chemtech-Ford holds the required national licenses and accreditations to conduct the
required analytical work. A copy of their Quality Manual is included in Appendix A. The
Environmental Laboratory and Quality Assurance Manager is:
Jennifer Osborn, Laboratory Director of Quality
Chemtech-Ford Inc.
9632 South 500 West
Sandy, Utah 84070
Phone: [phone]
Email: [e-mail]
Quality Assurance Project Plan
The Other Side Village Phase 2 | Salt Lake City, Utah
June 20, 2025 | Terracon Project No. 61257031
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Asbestos samples are planned to be sent to Eurofins EMLab P&K (EMLab). This laboratory
possesses the required national licenses and accreditations to conduct the asbestos
analytical work. A copy of their Quality Manual is included in Appendix A. The Quality
Assurance Director is:
Joshua Snyder, Quality Assurance Manager
Eurofins EMLab P&K
1501 W. Knudsen Drive
Phoenix, AZ 85027
[phone]
[e-mail]
Perfluoroalkyl and polyfluoroalkyl substances (PFAS) samples will be sent to either Pace
Analytical (see above) or Eurofins Sacramento (Eurofins). These laboratories possess the
required national licenses and accreditations to conduct the appropriate analytical work. A
copy of Eurofins’ Quality Manual is included in Appendix A. PFAS sampling guides to be
followed are provided in Appendix C. The Quality Assurance Director for Eurofins is:
Robert Hrabak, Quality Assurance Manager
Eurofins Sacramento
880 Riverside Parkway
West Sacramento, California 95605
[phone]
[e-mail]
Air samples (soil gas) will be analyzed by Pace Analytical or H&P Mobile Geochemistry, Inc.
(H&P). Located in Carlsbad, California, H&P holds the required national licenses and
accreditations to conduct the required air sample analytical work. A copy of their Quality
Manual is included in Appendix A. The Environmental Laboratory Director is:
Kristin Beckley, Quality Assurance Officer
H&P Mobile Geochemistry, Inc.
2470 Impala Drive
Carlsbad, CA
[phone]
[e-mail]
A5 Problem Definition/Background
The site is located at approximately 1882 West Indiana Avenue, Salt Lake City, Utah
(Exhibit 1). It was formerly included in the Redwood Road Dump CERCLA facility (Facility ID
UTD980961502). The current Phase 2 project area is comprised of approximately 29.4 acres
Quality Assurance Project Plan
The Other Side Village Phase 2 | Salt Lake City, Utah
June 20, 2025 | Terracon Project No. 61257031
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which are generally situated east and south of the area that was formerly landfilled,
although some landfill debris is anticipated to be present within the Phase 2 boundary.
Based on previous investigations conducted within the larger, 45-acre parcel, there have
been minimal impacts from landfilling and other industrial uses of the site and nearby
properties. Fill materials were identified at depths up to 3.5 feet below ground surface (bgs)
with benzo(a)pyrene (BAP), a polycyclic aromatic hydrocarbon (PAH), cadmium, and arsenic
reported at concentrations above their respective Cleanup Levels. Dissolved arsenic was
reported in groundwater at concentrations above the US EPA MCL and 1,4-dioxane;
hexavalent chromium; and several PFAS compounds including, perfluorooctanoic acid
(PFOA) and perfluorooctanesulfonic acid (PFOS), exceeded the US EPA Tap Water Screening
Levels. Chloroform was reported at concentrations exceeding the Target Sub-Slab and Near-
Source Soil Gas Vapor Intrusion Screening Level (VISL) for commercial and/or residential
properties. Additionally, US EPA has not established a VISL for methane; however, a
general industry practice is to use an Action Level of 5 percent of methane’s Lower
Explosive Limit (LEL) of 50,000 ppmv, or 2,500 parts per million by volume (ppmv).
Methane is present at elevated concentrations above the Action Level.
The UDEQ VCP has indicated that additional site characterization is needed to provide data
regarding current site conditions and to characterize the nature of the overlying fill material
so that proper disposal methods during site development can be assessed. A site
characterization work plan for additional investigation was requested by UDEQ VCP during a
meeting on January 14, 2025, and a QAPP was requested by UDEQ VCP in an email, dated
March 19, 2025.
A6 Project/Task Description and Schedule
The objectives of sampling at the Site are to:
Identify and document concentrations of contaminants of concern (COCs) in
groundwater and surface water. If COC concentrations are identified in groundwater
and surface water that exceed Cleanup Levels, the impacted groundwater and surface
water management method will be specified in the RAP.
Document concentrations of COCs in soil and fill materials. Where present, the
impacted soil and fill material management methods will be specified in the RAP.
Document concentrations of COCs in soil gas. If COC concentrations are identified in
soil gas that exceed Cleanup Levels, impact soil gas management methods will be
specified in the RAP.
A Site Characterization Work Plan was developed for the investigation to be conducted on
the site. The Work Plan detailed the contaminants of concern, sampling locations, and
sampling rationale.
Quality Assurance Project Plan
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The Work Plan included a detailed map of proposed sampling locations, as well as resource
and time constraints.
A7 Quality Objectives and Criteria for Measurement Data
A7.1 Data Quality Objectives
Data Quality Objectives (DQOs) are quantitative and qualitative statements that specify the
quality of data required to support the objectives of an investigation. DQOs are generated
through the DQO Process, as shown in Guidance on Systematic Planning Using the Data
Quality Objectives Process (QA/G-4) (US EPA; February, 2006).
A7.2 Measurement Performance Criteria
Table 1 provides measurement performance criteria, which are Data Quality Indicators
(DQIs) expressed in terms of precision, accuracy, representativeness, comparability,
completeness, and sensitivity (PARCCS). The DQIs provide verifiable measurement criteria
to assess data quality. Following is a brief definition of the PARCCS parameters, including
bias.
PARCCS Parameters
Precision The measure of agreement among repeated measurements of
the same property under identical or substantially similar
conditions, calculated as either the range or as the standard
deviation. Precision may also be expressed as a percentage of
the mean of the measurements, such as relative range or
relative standard deviation (coefficient of variation).
Bias The systematic or persistent distortion of a measurement
process that causes errors in one direction. Use reference
materials or analyze spiked matrix samples.
Accuracy A measure of the overall agreement of a measurement to a
known value; includes a combination of random error
(precision) and systematic error (bias) components of both
sampling and analytical operations.
Quality Assurance Project Plan
The Other Side Village Phase 2 | Salt Lake City, Utah
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Representativeness A qualitative term that expresses “the degree to which data
accurately and precisely represent a characteristic of a
population, parameter variations at a sampling point, a process
condition, or an environmental condition.” (ANSI/ASQC 1995)
Comparability A qualitative term that expresses the measure of confidence
that one data set can be compared to another and can be
combined for the decision(s) to be made.
Completeness A measure of the amount of valid data needed to be obtained
from a measurement system.
Sensitivity The capability of a method or instrument to discriminate
between measurement responses representing different levels
of the variable of interest.
The Consultant QA/QC Officer will evaluate the PARCCS parameters in terms of the DQIs
presented in Table 1.
Precision will be evaluated based on relative percent difference (RPD) as a measure
of reproducibility between laboratory control sample and duplicate (LCS/LCSD) pairs
and matrix spike and duplicate (MS/MSD) pairs (analytical precision), and between
field samples and field duplicate samples (field precision).
Bias and Accuracy will be evaluated through a review of the method blanks,
equipment blanks, trip blanks, LCS/LCSD, and MS/MSD summaries provided by the
laboratory. Method blank and Equipment Blank analyte concentrations are expected
to be below the laboratory’s Reported Detection Limits (RDLs), while the percent
recoveries for LCS/LCSD and MS/MSD pairs are expected to be within the
laboratory/method standards.
Representativeness will be ensured by use of appropriate sampling locations,
collection and preservation methods (including sample holding times), and analytical
procedures according to the approved SAPs.
Comparability will be ensured using standardized sampling procedures in accordance
with the approved SAP and QAPP, use of standardized and approved laboratory
analytical methods, and reporting the analytical results in appropriate and consistent
units.
Quality Assurance Project Plan
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Completeness is the ratio of valid measurements to the number of planned
measurements (valid measurements conducted by the laboratory from the collected
field data divided by the planned measurements indicated in the SAP), expressed as
a percentage, and the completeness goal for each individual Phase II ESA is 90%.
Sensitivity must be such that the laboratory reporting limits are sufficiently low as to
allow identification of analyzed constituent concentrations that are above applicable
regulatory screening levels.
Environmental samples submitted for laboratory analyses will be considered definitive,
consistent with US EPA Superfund Data Categories (US EPA; September 1993). Analytical
results will be evaluated using the following:
Soil sample results will be compared to the most recently published US EPA Regional
Screening Levels (RSLs) for residential and industrial use scenarios.
Groundwater and surface water sample results will be compared to the most recently
published US EPA Maximum Contaminant Levels (MCLs) for drinking water and the
EPA VISL Target Groundwater Concentrations. If an MCL is not established for an
analyte, the results will be screened against the US EPA RSL for tap water.
Soil vapor sample results will be compared to the most recently published US EPA
VISLs for residential and commercial use scenarios.
Samples of suspect asbestos containing building materials (ACBM) will be analyzed
and compared to regulatory guidance and standards at US EPA 40 CFR Part 60
Subpart M (Asbestos NESHAP) and UDEQ, Division of Air Quality standards at UAC
R307-801.
The analytical methodologies used to generate data will be sensitive enough to result in
laboratory method detection limits (MDLs) that are below the listed regulatory screening
levels or noted when this does not occur.
Certification and validation requirements apply to the laboratories. Regularly scheduled
analyses of known duplicates, standards, and spiked samples are a routine aspect of data
reduction, validation, and reporting procedures for the laboratories. The laboratory, which is
associated with the National Environmental Laboratory Accreditation Program (NELAP), will
verify the reliability and credibility of the analytical results. Analytical providers used will be
NELAP certified unless no other option is available. Additionally, when possible, the
laboratory reporting limits need to be lower than the screening levels for each of the
analytes. Copies of the laboratories’ Quality Assurance Manuals (QAM) with the laboratory
reporting levels are provided in Appendix A.
Quality Assurance Project Plan
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A8 Special Training Requirements
The Occupational Safety and Health Administration (OSHA) 40-hour Hazardous Waste
Operations and Emergency Response (HAZWOPER) training, including an up-to-date 8-hour
refresher course as required by OSHA, is required for field personnel. Initial 40-hour
HAZWOPER “live” training is provided by reputable training providers in the local
community, and annual refreshers are provided either by “live” training or via online
courses approved by Terracon’s Corporate Safety and Health Manager. The Consultant
Grant Manager will ensure that training/certification requirements are satisfied for all field
personnel prior to their entry to any project site where Phase II ESA activities are
conducted. Documentation (training certificates) of HAZWOPER and refresher training is
maintained by Terracon’s Corporate Safety and Health Manager in employees’ confidential
medical surveillance/environmental training files. In addition, Terracon’s environmental
project managers (or designees) are responsible for conducting site-specific safety briefings
prior to beginning all Terracon hazardous waste site projects. Terracon will ensure that a
certified underground storage tank (UST) Groundwater and Soil Sampler will collect on-site
samples when sampling is related to petroleum releases at a state-regulated site.
Terracon will prepare a site-specific Health and Safety Plan (HASP) prior to mobilizing to the
site to identify specific hazards that may be encountered during all phases of the field work.
Terracon will also require any onsite subcontractors (e.g., drillers) to provide documentation
of current HAZWOPER certification prior to mobilization, when required (e.g. would not be
applicable where asbestos containing materials or lead paint are the only concerns). In
addition, Terracon personnel that collect samples of potential asbestos-containing material
will be Certified Asbestos Building Inspectors as required by Utah Division of Air Quality
rules under UAC R307-801. Documentation of these certifications is maintained in Terracon
databases at both local and corporate levels.
A9 Documentation and Records
The data collected during any assessments will be summarized in reports documenting the
investigation procedures and results, along with supporting maps, figures, and data
summary tables. Appendices will include appended data for analyses, including laboratory
QA/QC evaluation, chain of custody documentation, and field forms. The reports will include
discussion and general recommendations for identified conditions that must be considered in
planning for future redevelopment, as applicable.
Field personnel will maintain a field log to record pertinent activities associated with
sampling activities. Photographic documentation will also be recorded in the field log, as will
documentation of issues that arise in the field and corrective measures taken. Additional
field documents will include sketch maps, field forms, borehole logs, and chain of custody
records.
Quality Assurance Project Plan
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Labels generated by the laboratory will be affixed to sample containers and completed by
field personnel. The labels will identify sample numbers, dates and times collected, and
requested analyses. Chain of custody records will be maintained for all samples from the
time of collection through the time of submittal to the laboratory for analysis.
Electronic project documents (including but not limited to word processing files,
spreadsheets, laboratory analytical reports, project photographs, and CAD/GIS files) will be
stored for a minimum of five years in an electronic project folder on Terracon’s internal
OneDrive cloud storage server that is backed up automatically daily. In addition, analytical
reports and chain-of-custody records will be maintained indefinitely on the analytical
laboratory’s LIMS (or similar) database and made available via the laboratory’s secured
online data access system.
Samples will be submitted to State of Utah certified laboratories using standard turnaround
times unless alternate turnaround times are requested on chain of custody records for
individual sample sets. It is anticipated that Pace Analytical will be used for most analyses;
however, Chemtech-Ford and H&P may also be utilized for environmental sampling if
deemed necessary. Eurofins EMLab is expected to be used for asbestos analyses. Pace
Analytical or Eurofins is expected to be used for PFAS analysis. If another laboratory
performs analyses, it must meet the following criteria and submit QA/QC documentation for
approval as described above:
demonstrated ability to achieve the required detection limits
certified by the State of Utah for the specific analyses
ability to meet the project’s analytical QC requirements, which includes a laboratory
method blank, laboratory control sample, matrix spike and matrix spike duplicate
performed on one of the project’s samples, narrative report of QC results, and any
corrective actions required
follows an internal QA/QC Program
data provided by the laboratory will be made available using similar methods (i.e.
electronic deliverables)
Details of Pace Analytical’s, Chemtech-Ford’s, H&P’s, EMLab’s, and Eurofins’ QA/QC
Programs are presented in Appendix B.
The QAPP will be reviewed, recertified, or updated on an as needed basis. The Division of
Environmental Response and Remediation (DERR) will be notified if updates to the QAPP are
required since it was initially published.
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Group B Measurement/Data Acquisition
B1 Sampling Process Design
A Work Plan will be developed for each investigation. Regulatory and historical data
available for the Site, a visual inspection of the property, and identified issues will be used
to develop the Work Plan. Each Work Plan will be reviewed and approved by the DERR prior
to implementation and will include the following information:
justification of design strategy and rationale for sampling locations (area, volume, or
time period to be represented by a sample)
type and total number of sample times/matrices or test runs expected and required
where samples are to be collected and how sampling locations will be identified and
located
discussion regarding procedures if sampling locations become inaccessible
Project activity schedules such as for each sampling event, when samples should be
sent to the laboratory, etc.
sources of variability and how this variability will be reconciled
B2 Sampling Methods Requirements
Samples will be collected following applicable Terracon Standard Operating Procedures
(SOPs) included in Appendix A. The SOPs include lists of equipment needed for each SOP
and were developed in general accordance with Guidance for Preparing Standard Operating
Procedures (SOPs) (QA/G-6) (US EPA, April 2007). If problems develop in the field during
implementation of an SOP, field personnel will contact the Consultant Project Manager and
Consultant QA/QC Officer for information on appropriate corrective action, and the issue and
corrective action will be documented in the field logbook.
PFAS compounds are found in a variety of sources including standard equipment used to
collect environmental samples, and these compounds have very low detection limits. As a
result, proper care and special handling must be taken when collecting such samples.
Terracon has produced specific SOPs for collecting PFAS samples in various media
(Appendix A). Additionally, Pace has published a PFAS Field Sampling Guide that will be
followed when PFAS samples are to be collected (Appendix C). Finally, the Minnesota
Pollution Control Agency (MPCA) has released a guidance document regarding PFAS
sampling that will be consulted prior to doing this work. This regulatory document is used
by Terracon staff nationwide and is included in Appendix C. Sampling procedures will be
updated as new US EPA guidance becomes available.
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B3 Sample Handling, Preservation, and Custody Requirements
Samples will be identified, labeled, preserved, and handled following SOP E.0026, which
includes chain of custody and documentation procedures.
Required sample containers, sample volumes, sample holding times, and sample
preservation methods for a variety of analytical parameters including those that are likely to
be used in the proposed assessments are summarized in the individual laboratory’s QAM,
detailed in Appendix A of this QAPP and are presented in Table 2. The primary analytical
parameters anticipated for the assessments include, but are not limited to, the following:
volatile organic compounds (VOCs; US EPA Method 8260); semi-volatile organic compounds
(SVOCs/PAHs; US EPA Method 8270 SIM); metals (US EPA Methods 6010//6020/7470/
7471); polychlorinated biphenyls (PCBs; US EPA Method 8082); per-and polyfluoroalkyl
substances (PFAS, US EPA Method 1633), pesticides (US EPA Method 8081), and 1,4-
dioxane (US EPA Method 8260 SIM). Soil gas samples will be analyzed for VOCs and
methane using US EPA Method TO-15.
Samples will be placed into the appropriate laboratory-provided container after collection.
The container will remain in the sight of the sampler or will be locked in a secure area until
the samples are transported under chain of custody protocols for delivery to the laboratory.
Samples will be prepared, packaged, and shipped in a manner to arrive at the laboratory
intact and at an acceptable temperature.
The Work Plans developed will provide specific details as to the analytes being sampled,
laboratory methods being utilized, QA/QC information, and additional analyte-specific
information, as appropriate.
B4 Analytical Methods Requirements
Analytical methods will follow standard EPA procedures as outlined in Test Methods for
Evaluating Solid Wastes—Physical/Chemical Methods (SW-846) as updated. Please refer to
SW-846 and the laboratory QAMs (Appendix A) for analytical SOPs and information
regarding analytical equipment, instrumentation, performance criteria, corrective action
procedures and documentation, sample disposal, method validation information, and
procedures for nonstandard methods. Laboratory turnaround times needed will be specified
on chain of custody records for each sample set but will typically be the standard laboratory
turnaround time of 10 business days. Turnaround times for PFAS samples can vary widely
but are often at least 21 days.
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B5 Quality Control Requirements
B5.1 Definitive Data
To ensure that high quality, reliable data are consistently collected, and that data are
comparable to previous investigations, QA procedures will be followed throughout the
investigation. Quality assurance procedures include using the data quality objectives,
following SOPs, and collecting and analyzing field and laboratory QC samples.
QC samples collected in the field will be preserved, handled, and transported in an identical
manner as the environmental samples. QC samples will include the following:
field duplicates
field/equipment blanks (if applicable for individual sampling locations)
trip blanks (if applicable for individual sampling locations)
matrix spikes and matrix spike duplicates (MS/MSDs)
laboratory method blanks
laboratory control samples and laboratory control sample duplicates (LCS/LCSDs)
Split samples will be collected by VCP staff, as needed.
Laboratory quality control samples (method blanks, MS/MSD, LCS/LCSD) will be analyzed at
a frequency of no less than one per twenty samples or analytical batch. Quality control
samples are briefly described below.
Field Duplicate Samples.To evaluate sampling and laboratory precision, field duplicate
samples may be collected at a rate of 10 percent, or as specified in the work plan. One
sample set will be labeled with the correct sample identification, while the other will be
labeled with a false or “blind” sample identification. If the detected analytes in the field
sample and its duplicate are less than 5 times the laboratory reporting detection limit (RDL)
and the difference between the reported concentration in the sample and the reported
concentration in the duplicate is less than or equal to the RDL value (for aqueous samples)
or less than twice the RDL (for soil/solid samples), the samples will be considered within
control. If the difference is greater than the RDL value, the data will be flagged and
evaluated by the Consultant QA/QC Officer.
The RPD between detected analytes in the field sample and its duplicate are calculated
when the reported concentrations for the sample and duplicate are greater than, or equal to
five times the RDL. The RPD is calculated to evaluate precision using the following equation.
RPD =𝑋1 −𝑋2
ቀ𝑋1 +𝑋2
2 ቁ
𝑥100 Where X1 and X2 are the reported concentrations of the
samples being evaluated.
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The target RPD values for samples and their duplicates will be ±25% (for aqueous samples)
and ±50% (for solid samples, due to greater sample heterogeneity). If samples exceed the
target RPD values, the data will be flagged and evaluated by the Consultant QA/QC Officer.
The samples may be used on a conditional basis if sample heterogeneity or matrix
interference appears to be the cause of the high RPD value.
Field/Equipment Blank. Field equipment (rinsate) blanks may be collected, as specified in
the Work Plan. Acceptance criteria will be analyte concentrations less than the RDLs. If
above the RDLs, the data will be flagged and evaluated by the Consultant QA/QC Officer.
The Consultant QA/QC Officer will review the sampling procedures and equipment to
determine if contaminants could have been introduced by the sampling methodology. When
necessary, the results will be discussed with the Agencies, laboratory personnel, and/or
appropriate regulatory officials to determine if the data are acceptable or should be
rejected.
Trip Blanks. Trip blanks will apply only when a work plan includes collection of samples to
be analyzed for VOCs and PFAS and will be used to evaluate whether external VOCs from
bottle handling and analytical processes, independent of the field sampling processes, are
contaminating the samples. Trip blanks will be prepared by the laboratory with analyte-free
water prior to the sampling event, kept with the investigative samples throughout the
sampling event, and returned to the laboratory with the other samples for analysis. One trip
blank will typically be used and analyzed per sample shipment when sample analyses
include VOCs and/or PFAS. Acceptance criteria will be analyte concentrations less than the
RDLs. If concentrations are above the RDLs, the data will be flagged and evaluated by the
Consultant QA/QC Officer. The Consultant QA/QC Officer will review the shipping procedures
to determine if contaminants could have been introduced by the shipping methodology.
When necessary, the results will be discussed with the DERR, laboratory personnel, and/or
appropriate regulatory officials to determine if the data are acceptable or should be
rejected.
Matrix Spike (MS) and Matrix Spike Duplicate (MSD) Samples. Samples for MS/MSD
analyses will be selected by the consultant from field samples collected from the site being
investigated, whenever possible. The MS/MSD samples will be spiked in the laboratory with
target analytes prior to extraction or analysis, according to the laboratory’s SOPs, and then
analyzed for the same compounds as the environmental samples. Each MS/MSD will be
evaluated for Percent Recovery (PR). If the data meets the PR criteria, the MS/MSD will be
evaluated for RPD according to the equation presented in the Field Duplicate Samples
section.
Percent Recovery =𝑋𝑠−𝑋𝑖
𝑆𝐶𝑥100 Where Xs = concentration measured in spiked sample
Xi = concentration measured prior to spiking,
and
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SC = spike concentration
The PR acceptance criteria for MS/MSD samples will vary by sample medium, analyte, and
analytical method, and may be either method defaults or laboratory-derived. Laboratory
RPD acceptance criteria also vary by sample medium, analyte, and analytical method, and
are specified in the QAMs (Appendix A). Each laboratory report will include quality control
summaries with PR results and comparison against PR acceptance criteria for each sample
medium, analyte, and analytical method for that sample set. Additionally, specific control
limits will be included in the individual data report packages. If data fail to meet the
acceptance criteria, the Consultant QA/QC Officer will evaluate the data with the laboratory
to assess potential causes of failure, such as matrix interference or sample heterogeneity.
Data may be flagged or invalidated based on discussions with the laboratory.
Laboratory Method Blanks. Method blank samples will be prepared by the laboratory and
analyzed with each analytical batch for each method. A method blank consists of laboratory-
grade deionized water or solid that is processed through all the analytical steps required by
a method, including sample extraction, preparation, and analysis. Laboratory method blank
samples are used to identify contamination originating in the laboratory, such as laboratory
water, reagents, sample preparation steps, and instrument contamination. Method blank
samples aid in distinguishing low-level field contamination from laboratory contamination.
Method blank samples will be run with each batch of samples (20 or fewer samples per
batch). If analytes are detected in the method blank, the laboratory will correct problems as
per their SOPs. The Consultant QA/QC Officer will evaluate the data to determine whether a
detection in the corresponding Method Blank affects the usability of the data.
Laboratory Control Samples (LCS). Laboratory control samples are used to evaluate
laboratory accuracy in the absence of matrix interference. A laboratory control sample is
composed of laboratory-grade deionized water or clean solid that is spiked with target
analytes according to the laboratory’s SOPs prior to extraction or analysis. The percent
recovery of the spiked compounds is calculated and compared to established QC limits using
the following formula.
Percent Recovery =𝑋𝑠
𝑆𝐶𝑥100 Where Xs = concentration measured in spiked sample,
and
SC = spike concentration
Acceptance criteria for the LCS will vary by sample medium, analyte, and analytical method;
may be either method defaults or laboratory-derived; and are compared against PR results
in the laboratory quality control summaries provided as part of each laboratory report. If the
LCS is out of control, the laboratory will correct problems in accordance with its standard
operating procedures. If the data meets the PR criteria, the LCS/LCSD will be evaluated for
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RPD according to the RPD equation presented previously. The Consultant QA/QC Officer will
evaluate the LCS/LCSD data to determine whether any issues or variations affect the
usability of the data.
Holding Times. Holding times are used to evaluate the representativeness of the
environmental samples. Holding time is the period following sample collection when a
sample is considered representative of the environmental conditions. The holding time for
each analysis will be compared to the method-specific holding times. Samples held beyond
their holding time prior to analysis will be evaluated by the Consultant QA/QC Officer and
the laboratory to determine whether the data can still be utilized to some capacity or must
be rejected.
B5.2 Non-definitive data
Non-definitive data utilized to support decisions may include field soil screening
measurements and observations, physical observations, and groundwater and surface water
field parameter measurements. Non-definitive data will be collected following Terracon SOPs
(Appendix A). The QC documentation for non-definitive data is not as rigorous as
requirements for definitive data.
B6 Equipment Testing, Inspection, and Maintenance
Requirements
Testing, inspection, and maintenance of sampling equipment and field instrumentation will
be performed by Terracon field personnel prior to each day’s field use and in accordance
with the procedures and schedules in the manufacturers’ specifications. A supply of
appropriate spare parts and batteries will be maintained with each instrument in its
transport case, along with instrument calibration supplies. Identified deficiencies will be
documented in the field logbook, along with any corrective actions (e.g., spare parts
replacement and instrument re-testing) and effectiveness of corrective actions.
Pace Analytical, Chemtech-Ford, H&P, EMLab, and Eurofins conduct their own equipment
testing, inspections, maintenance, and record keeping of the laboratory equipment as
detailed in the laboratory QAMs provided in Appendix A.
B7 Instrument/Equipment Calibration and Frequency
B7.1 Field Instruments
Field instruments will be calibrated daily or in accordance with manufacturers’ specifications
by Terracon field personnel, using National Institute of Standards and Technology (NIST)
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standards or equivalent. Calibration deficiencies, if any, will be documented in the field
logbook along with their resolution (e.g., spare parts replacement and re-calibration).
B7.2 Laboratory Instruments
The laboratories QAM and SOPs meet State of Utah, The NELAC Institute, and US EPA
method protocols necessary to produce legally and defensible analytical data. Certification
also applies to instrument calibration, reference material, standards traceability, data
validation, and other aspects of the QAM.
In the event of a negative audit finding or any other circumstance, which raises doubt
concerning the laboratory’s competence or compliance with required procedures, the
laboratory ensures that those areas of concern are quickly investigated. A resolution of the
situation is promptly sought and, where necessary, recalibration and retesting are
conducted. Records of events and corrective actions taken by the laboratory to resolve
issues and to prevent further occurrences are maintained. Additional information on
laboratory corrective actions is described in each laboratory’s QAM (Section 4.11 Pace
Analytical and Chemtech-Ford, Section 9.6 H&P, Section 14.0 EMLab, and Section 14.0
Eurofins).
B8 Inspection/Acceptance Requirements for Supplies and
Consumables
Sample containers and other dedicated consumables will meet US EPA criteria for cleaning
procedures required for low-level chemical analysis. Sample containers will have Level II
certification provided by the manufacturer, in accordance with pre-cleaning criteria
established by US EPA in “Specifications and Guidelines for Obtaining Contaminant-Free
Sample Containers.” The certificates of cleanliness are maintained by the container suppliers
and can be obtained upon request using the container batch and lot numbers. Sample
containers and sample preservatives (where applicable) will be provided by the laboratory.
The containers shall be pre-preserved by the laboratory, if possible, prior to the sampling
event, if required. In addition, the laboratory will supply the laboratory-grade deionized
water and PFAS-free water for the field and equipment blanks. The laboratory-grade
deionized water may be prepared by the laboratory in-house, but the laboratory must have
a routine procedure in place to analyze the water to ensure the deionized water’s quality.
New disposable nitrile sampling gloves will be used during collection of samples and will be
discarded after collection of each sample. If soil gas testing is required, Summa canisters
will be batch-certified by the laboratory. New disposable water filters (if required) and
pumps/tubing will be used to collect groundwater samples and will be discarded after use. A
bailer and/or decontaminated remote sampling device will be used to collected surface
water samples, if present. New disposable tubing and connections and a dedicated flow
controller will be used to collect each soil gas sample. Prior to use, the materials provided
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by the laboratory or other suppliers will be inspected visually for signs of tampering,
contamination, or damage. No evidence of tampering, contamination, or damage will be
acceptable. The field team leader will be responsible for the inspection. Reserves of field
supplies and consumables are stored and maintained in Terracon’s secured storage
warehouse and used as needed by field personnel for each day’s field activities, and the
reserves of consumables are re-ordered/replenished as needed by Terracon staff. Sample
supplies and containers used for PFAS sampling will be ordered directly from the laboratory
prior to use on that specific project.
B9 Data Acquisition of Non-direct Measurements
Additional data may be collected and used for site characterization following SOPs. QA
procedures will be followed throughout the investigation. External sources of existing data
may also be used (for example, computer databases or regulatory files of previously
investigated sites); such information will be used only for reference. This type of data will
be considered non-definitive for the purpose of assessing selected sites, unless the data was
collected following an Agency-approved work plan, evaluated following a QAPP that meets
or exceeds the requirements provided in this QAPP, validated, and deemed definitive.
B10 Data Management
The results of each investigation will be compiled and detailed in a report. Please refer to
Section A9 for information pertaining to documentation that will be generated during the
project, and storage requirements for these records.
Data will be processed using commercially available word processing, spreadsheet, and/or
database programs. During transcription of field measurements, each entry will be double-
checked immediately after each transcription from field logbooks and forms, as detailed in
Appendix A. To minimize potential errors in laboratory data transcription, the use of
electronic data deliverables (EDDs) will be maximized during data entry to summary tables
and databases. The control mechanism to detect and correct errors in data transcription,
reduction, reporting, and data entry to forms, reports, and databases will be the senior peer
review of documents by the Consultant Project Manager and Consultant QA/QC Officer. Data
will be stored electronically, both on a local server hard drive and on the laboratory’s LIMS
(or similar) database system and can be retrieved via the local server and via the
laboratory’s secure online data access system. Please refer to Appendix A for information
relating to procedures used and individuals responsible for laboratory data processing,
transmittal, storage/archival, and hardware/software configurations.
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Group C Assessment/Oversight
C1 Assessment Activities
The Consultant QA/QC Officer will conduct assessment and oversight activities. There will be
three primary activities conducted by the Consultant QA/QC Officer:
Surveillance Level Oversight: The Consultant Project Manager will coordinate the
investigation, with independent oversight by the Consultant QA/QC Officer. Both
individuals will have authority to stop work in the event of unsafe work conditions or
deviation from SOPs. In the event of unsafe work conditions, field personnel will also
have authority to stop work and will immediately contact the Consultant Project
Manager for resolution. Deviations from the QAPP will be addressed to ensure the
quality of the data. Surveillance level oversight will be conducted throughout the
duration of field activities.
Performance Evaluations: The Consultant QA/QC Officer will verify that the laboratory
certifications and methods are current and approved by the NELAP, prior to the
initiation of field sampling.
Data Quality Validation Summary: After receipt of analytical data sets from the
laboratory, the Consultant Project Manager will perform an initial review of the data,
followed by a data validation review by the Consultant QA/QC Officer to determine
whether DQOs were met and evaluate the overall usability of the data. The results of
these data validation reviews will be communicated to the Consultant Project
Manager, who will notify the laboratory if a need for corrective actions is identified. In
this case, the laboratory will be required to perform and verify corrective actions
taken, which will then be documented in an amended laboratory report identifying the
corrective actions taken and any resulting changes to the analytical results. In
addition, the data validation reviews will form the basis for development of data
validation summaries for inclusion with the final site investigation reports.
Salt Lake City Review: Once the work has been completed, performance evaluations
have been conducted, and the data has been validated, a report including this data
will be submitted to Salt Lake City for review, further data assessment, and
validation.
C2 Reports to Management
Data validation summaries will be included as part of the final reports detailing the
investigations. If laboratory corrective actions are required, the Consultant Project Manager
will notify Salt Lake City, and final reports will include copies of both the original and
amended laboratory reports. If field corrective actions are required, the problem and
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corrective action will be recorded in the field logbook and will also be documented in the
final report. Copies of the final reports detailing the investigations will be sent to the parties
listed in Section A3 Distribution List.
Group D Data Validation And Usability
D1 Data Review
Following receipt of the laboratory analytical results and initial review by the Consultant
Project Manager, the data will be forwarded to the Consultant QA/QC Officer for review
which will include initial screening to evaluate whether any of the data is flagged or if
laboratory control limits were not met. Upon acceptance of the data from the laboratory, the
data will be validated. The data validation process evaluates whether the specific
requirements for an intended use have been fulfilled and that the results conform to the
users’ needs.
D2 Validation and Verification Methods
Laboratory data will be subject to internal reduction and validation by the laboratory prior to
external release of the data, as detailed in the laboratory’s QAM in Appendix A.
Following receipt of data released by the laboratory, additional data validation and
verification will be conducted by the Consultant QA/QC Officer, using the criteria described
in Section B5.1 and Table 3, and including review of chain of custody and laboratory log-in
records. Data will be reviewed as it is received throughout the project. Each laboratory data
set will be provided by the laboratory and will include the final analytical report with
qualifiers, where necessary; case narratives; chain of custody records; and results for
method blanks, MS/MSD analyses with control limits; LCS/LCSD summary with control
limits; reporting limits listed on the reports; and surrogate recoveries.
Laboratory QC issues will be addressed by communication between the Consultant QA/QC
Officer and laboratory personnel. Problems identified in sample collection, handling,
preservation, and documentation will be addressed with the Consultant Project Manager and
field staff.
Deviations from the QA goals will be evaluated in terms of their effect on data usability. The
degree of sample deviation beyond the acceptance limit will be evaluated for its potential
effect on data usability, contribution to the quality of the reduced and analyzed data, and on
decision-making for the project. The final report to Salt Lake City will include a discussion of
data usability effects due to deviations from the work plan or QA goals summarized by the
Consultant QA/QC Officer.
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D3 Reconciliation with User Requirements
Following the validation of field and laboratory data, all data and information will be
reconciled with the project objectives to assess the overall success of sampling activities.
Qualitative DQOs will be reviewed through a narrative discussion of the results to include
limitations, if any, on data use due to uncertainties posed by any flagged data or elevated
laboratory reporting limits. If such uncertainties result in significant hindrances to data
usability, practical follow up actions (for example, limited resampling) may be
recommended, as warranted.
Group E References
US Environmental Protection Agency, April, 2007,Guidance for Preparing Standard
Operating Procedures (SOPs) (QA/G-6). EPA/600/B-07/001.
US Environmental Protection Agency, February, 2006,Data Quality Assessment: A
Reviewer’s Guide (QA/G-9R). EPA/240/B-06/003.
US Environmental Protection Agency, February, 2006,Data Quality Assessment: Statistical
Tools for Practitioners (QA/G-9S). EPA/240/B-06/002.
US Environmental Protection Agency, December, 2002,Guidance for Quality Assurance
Project Plans (QA/G-5). EPA/240/R-02/009.
US Environmental Protection Agency. February, 2006 Guidance on Systematic Planning
Using the Data Quality Objectives Process (QA/G-4). EPA/240/B-06/001.
US Environmental Protection Agency, September, 1993,Data Quality Objectives Process for
Superfund – Interim Final Guidance. Pub. No. 9355-9-01.
US Environmental Protection Agency.Regional Screening Levels (RSLs).
www.epa.gov/risk/regional-screening-levels-rsls
US Environmental Protection Agency. National Primary Drinking Water Regulations.
www.epa.gov/ground-water-and-drinking-water/national-primary-drinking-water-
regulations
Utah Department of Environmental Quality.Summary of Groundwater and Soil Cleanup
Screening Levels.
www.deq.utah.gov/ProgramsServices/programs/tanks/lust/docs/2006/08Aug/cleanu
pLevels.pdf
Exhibits
Draft
6949 South High Tech Drive Midvale, Utah 84047
PH. [phone] FAX. [phone]
2
ExhibitPROJECT ORGANIZATION CHART
TOSV Phase 2
Approximately 1882 West Indiana Ave
Salt Lake City, Utah
Project Manager
Drawn By:
Checked By:
Approved By::
JH
JH
AA
AA
Project No.
Scale:
File Name:
Date:
NA
F1 Org Chart
3/2025
Chemtech Ford
Analytical and
Pace Analytical
(Laboratories)
TERRACON FIELD
STAFF
UTAH DEPT. OF
ENVIRONMENTAL
QUALITY
Allison Stanley
CONSULTANT
PROJECT MANAGER
Jill Hernandez
(Terracon)
CONSULTANT QA/QC
OFFICER
Andrew S. Turner, PG
(Terracon)
61257031
SALT LAKE CITY
CORPORATION
Catherine Wyffels
THE OTHER SIDE
ACADEMY
Tim Stay
Draft
Tables
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Table 1 Data Quality Indicators (DQIs)
Parameter QC Program Evaluation Criteria Summary of QA/QC Goals
Precision
Laboratory Precision
LCS/LCSD Pairs
MS/MSD Pairs
Field Precision
Field Duplicate Pairs
RPDa
Laboratory Precision
LCS/LCSD RPDs and MS/MSD RPDs will be less than the laboratory-derived limits
Field Precision
Field Duplicate Pair RPDs will be less than ± 25% (aqueous samples) and ± 50%
(solid samples) when detected concentrations are ≥ 5x the RDL. When detected
concentrations are <5x the RDL and the difference between the reported
concentrations is less than or equal to the RDL value (for aqueous samples) or
less than twice the RDL (for soil/solid samples), the samples will be considered
within control
Bias
LCS/LCSD Percent Recoveryb LCS/LCSD percent recoveries will vary by sample medium, analyte, and method,
and control limits may be either method defaults or laboratory-derived.
MS/MSD Percent Recoveryb MS/MSD percent recoveries will vary by sample medium, analyte, and method,
and control limits may be either method defaults or laboratory-derived.
Accuracyc
Method Blanks RDL Less than RDL
Equipment Blanks RDL Less than RDL
Representativeness
SAPs and SOPs Qualitative determination of SAP and
SOP adherence All samples collected following site-specific SAPs and SOPs
Holding Times Holding Times All samples analyzed within holding times
Field/Equipment/Trip Blanks RDL Less than RDL
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Parameter QC Program Evaluation Criteria Summary of QA/QC Goals
Comparability
Units of Measure Metric Units 100% of sample results reported in same units
Analytical Methods Approved Methods 100% of samples analyzed using approved methods
Standardized Sampling Qualitative determination of SAP and
SOP adherence All samples collected following site-specific SAPs and SOPs
QC Samples
10% Field Duplicates (per Site)
10% Field Blanks (or as described in SAP)
Lab QA
Verify
Verify
Verify
100% compliance
100% compliance
100% compliance
Completeness Complete Sampling Percent Valid Data 90% or more of the planned measurements are valid
Sensitivity Sample analyses RDL 100% of RDLs are less than Performance Standards
a: RPD (Relative Percent Difference) =𝑋1 −𝑋2
ቀ𝑋1+𝑋2
2 ቁ 𝑥100; where X1 and X2 are the reported concentrations of the samples being evaluated.
b: Percent Recovery =𝑋𝑠−𝑋𝑖
𝑆𝐶𝑥100; where Xs = concentration measured in spiked sample, Xi = concentration measured prior to spiking, and SC = spike concentration.
c: Instrument calibration, reference material, standards traceability, and data validation will follow Pace Analytical’s Standard Operating Procedures.
LCS/LCSD: Laboratory Control Sample/Laboratory Control Sample Duplicate
MS/MSD: Matrix Spike/Matrix Spike Duplicate
RDL: Laboratory Reported Detection Limit
RPD: Relative Percent Difference
SAP: Sampling and Analysis Plan
SOP: Standard Operating Procedure
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Table 2: Method Summary
Parameter Matrix Analytical
Method
Laboratory Method
Detection Limit (MDL)Container Preservative Temp
Maximum
Holding Time
(days)
Asbestos Building Materials
3013 (polarized
light
microscopy)
and 3001 (400
point count)
<1%NA NA NA NA
VOCs Soil SW-846 8260 0.0004–0.01 mg/kg 4 oz glass NA 4°C*14
SVOCs/PAHs Soil SW-846 8270
SIM 0.0006–0.002 mg/kg 4 oz glass1 NA 4°C*14
Metals Soil SW-846 6000,
7000 Series 0.0843–0.2 mg/kg 4 oz glass NA 4°C*1802
PCBs Soil 8082 0.00738–0.01182 mg/kg 4 oz glass NA 4°C*365
VOCs Groundwater /
Surface Water SW-846 8260 0.000212–0.01 mg/L 3 x 40 ml HCL 4°C*14
1,4-dioxane Groundwater /
Surface Water
SW-846
8270C-mod 0.0003 mg/L 2 x 100 ml
amber glass NA 6°C*7
Dissolved
Metals
Groundwater /
Surface Water
SW-846 6000,
7000 Series 0.000478 to 0.0075 mg/L 250 ml HDPE3 HNO3 NA 1802
Quality Assurance Project Plan
The Other Side Village Phase 2 | Salt Lake City, Utah
June 20, 2025 | Terracon Project No. 61257031
Facilities | Environmental | Geotechnical | Materials
Parameter Matrix Analytical
Method
Laboratory Method
Detection Limit (MDL)Container Preservative Temp
Maximum
Holding Time
(days)
Dissolved
Hexavalent
Chromium
Groundwater /
Surface Water 3500 Cr 0.0001 mg/L
50 ml HDPE
tube with
plunger
pH buffer 6°C 28
PFAS Groundwater /
Surface Water 1633 0.000151 to 0.00523 µg/L
2 x 500mL
Poly and 1 x
125mL Poly
(PFAS-and
Teflon-free)
NA 4°C*40
TDS Groundwater /
Surface Water SM 2540 C 20 mg/L 250 ml HDPE NA 6°C*7
VOCs Soil Gas TO-15 0.587-6.32 µg/m3
1 L Summa NA NA
30
Methane Soil Gas 8015M 6.98 ppmv µg/m3 14
1May be combined with other analyses.
2Mercury has a 28-day holding time.
HCL = hydrochloric acid; HNO3 - nitric acid
NA: Not Applicable/Not Required
3Filtered in the field using a 0.45 µm filter
kg = kilogram;L = liter; mg = milligrams;m3 = cubic meter; ml = milliliter;
ng = nanograms; oz: ounce; µg = micrograms
*If samples are delivered to the laboratory on the day of
collection, they must be placed on ice, but it is not necessary
to reach 4 deg C.
Table 3
Data Validation and Verification Methods
Data Validation and Verification
Requirements
Data Validation and Verification Methods
Samples were collected as per
scheduled locations and frequency.Comparison with SAPs.
Sample collection and handling
followed specific procedures (i.e.,
relevant SOPs and chain-of-custody
procedures).
Review of field notes, sampling logs and COCs.
Surveillance-level oversight of field procedures
to maximize consistency in field.
Appropriate analytical methods were
used, and internal laboratory
calibration checks were performed
according to the method-specified
protocol.
Review of analytical methods and case
narratives provided with laboratory reports.
Maintain documentation of communications
with the laboratory regarding problems or
corrective actions.
Required holding times and laboratory
reporting limits were met.
Comparison with specified holding times and
RDLs.
Recovery acceptance limits for field
and laboratory QC samples (MS/MSD,
LCS/LCSD, and method blanks) were
met.
Comparison with specified acceptance limits.
Comparison with Data Quality Indicators.
Appropriate steps were taken to ensure
the accuracy of data reduction,
including reducing data transfer errors
in the preparation of summary data
tables and maps.
Maintaining a permanent file of hard copies of
laboratory analytical reports.
Minimizing retyping of data.
Double-checking values entered into the
database, tables, and maps against laboratory
reports.
Appendices
Appendix A
Pace Analytical, Chemtech-Ford, Eurofins EMLab, and
H&P Quality Assurance Manuals
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COPYRIGHT © 2019-2022 Pace® Analytical Services, LLC.
Laurence Hayden Approved on 9/1/2022 1:01:26 PM
Robert Johnson Approved on 8/15/2022 4:06:20 PM
Elizabeth Turner Approved on 9/1/2022 7:55:17 PM
Rebecca King Approved on 9/2/2022 8:32:34 AM
Page 1 of 221
Title Page
Quality Manual
Pace Analytical Services, LLC
Prepared for:
ESC dba Pace® Analytical National Center for Testing and Innovation
12065 Lebanon Road
Mt. Juliet, TN 37122
Phone: [phone]
Parent Company: Pace® Analytical Services, LLC
Signatory Attestation: I attest the application of my electronic signature on this title page affirms my
management commitment and responsibility to uphold the requirements of the PAS Quality Management
System (QMS) described in this Quality Manual (manual) at each location for which this manual is prepared.
Refer to the Quality Manual Signatory Page to view the job title and physical address for each signatory.
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Quality Manual Approval Signatories
The following individuals represent the PAS corporate and local management team responsible for
implementing the PAS Quality Management System (QMS) and upholding the requirements of this
manual at the location(s) for which this manual was prepared, at the time this version of the manual
was made effective, and that correlate with the electronic signatures shown on the title page of this
manual.
If these persons(s) change positions, leave the company, or are on extended leave of absence, the
approval of this manual automatically transfers to the person replacing the signatory or to the
signatory’s primary or alternate deputy until the manager is replaced and/or the manager returns to
work. The individual replacing the signatory automatically accepts the responsibilities associated with
the original signatory’s attestation. Refer to Section 4.1.5.1.1 of this manual for the deputies assigned
to key personnel job titles.
The manual is not revised and released under an updated version for the sole purpose of updating
personnel change(s). Personnel information is updated when the next revision of the manual is
released. See manual Sections 1.2.1 and 1.2.2 for more information about how this manual is
maintained.
Name Job Title Address, City, State, ZIP Phone
Laurence Hayden Vice President of Operations Texas [phone]
Eric Johnson Director of Lab Operations 12065 Lebanon Rd.
Mt. Juliet, TN 37122
[phone]
Elizabeth Turner Quality Program Manager 400 West Bethany Drive, Suite 190
Allen, TX 75013
[phone]
Rebecca King Quality Manager 12065 Lebanon Rd.
Mt. Juliet, TN 37122
[phone]
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TABLE OF CONTENTS
1.0 PURPOSE AND SCOPE 7
1.1 PURPOSE 7
1.2 SCOPE AND APPLICATION 7
1.2.1 QUALITY MANUAL TEMPLATE 8
1.2.2 QUALITY MANUAL 9
1.2.3 REFERENCES TO SUPPORTING DOCUMENTS 9
2.0 REFERENCES 9
3.0 TERMS AND DEFINITIONS 10
4.0 MANAGEMENT REQUIREMENTS 11
4.1 ORGANIZATION 11
4.1.1 LEGAL IDENTITY 11
4.1.2 COMPLIANCE RESPONSIBILITY 11
4.1.3 SCOPE OF THE QUALITY MANAGEMENT SYSTEM 11
4.1.4 ORGANIZATION HISTORY AND INFORMATION 11
4.1.5 MANAGEMENT REQUIREMENTS 12
4.2 QUALITY MANAGEMENT SYSTEM 18
4.2.1 QUALITY MANAGEMENT SYSTEM OBJECTIVES 18
4.2.2 QUALITY POLICY STATEMENT 20
4.2.3 MANAGEMENT COMMITMENT: QUALITY MANAGEMENT SYSTEM 21
4.2.4 MANAGEMENT COMMITMENT: CUSTOMER SERVICE 21
4.2.5 SUPPORTING PROCEDURES 22
4.2.6 ROLES AND RESPONSIBILITIES 23
4.2.7 CHANGE MANAGEMENT 23
4.3 DOCUMENT CONTROL 23
4.3.1 GENERAL 23
4.3.2 DOCUMENT APPROVAL AND ISSUE 24
4.3.3 DOCUMENT REVIEW AND CHANGE 24
4.4 ANALYTICAL SERVICE REQUEST, TENDER, AND CONTRACT REVIEW 24
4.5 SUBCONTRACTING (INTERNAL AND EXTERNAL) 25
4.6 PURCHASING SERVICES AND SUPPLIES 26
4.7 CUSTOMER SERVICE 26
4.7.1 COMMITMENT TO MEET CUSTOMER EXPECTATIONS 26
4.7.2 CUSTOMER FEEDBACK 26
4.8 COMPLAINTS 27
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4.9 NONCONFORMING WORK 27
4.9.1 DEFINITION OF NONCONFORMING WORK 27
4.10 CONTINUOUS IMPROVEMENT 29
4.11 CORRECTIVE ACTION 29
4.11.1 CAUSE ANALYSIS (AKA ROOT CAUSE ANALYSIS) 30
4.11.2 EFFECTIVENESS REVIEW 30
4.11.3 ADDITIONAL AUDITS 30
4.12 PREVENTIVE ACTION 31
4.12.1 CHANGE MANAGEMENT 31
4.13 CONTROL OF RECORDS 31
4.13.1 GENERAL REQUIREMENTS 31
4.13.2 TECHNICAL RECORDS 33
4.14 AUDITS 34
4.14.1 INTERNAL AUDIT 34
4.15 MANAGEMENT REVIEW 35
4.16 DATA INTEGRITY 36
5.0 TECHNICAL REQUIREMENTS 36
5.1 GENERAL 36
5.2 PERSONNEL 37
5.2.1 PERSONNEL QUALIFICATIONS 37
5.2.2 TRAINING (REQUIRED) 38
5.2.3 PERSONNEL SUPERVISION 42
5.2.4 JOB DESCRIPTIONS 42
5.2.5 AUTHORIZATION OF TECHNICAL PERSONNEL 43
5.3 ACCOMMODATIONS AND FACILITIES 43
5.3.1 FACILITIES 43
5.3.2 ENVIRONMENTAL CONDITIONS 43
5.3.3 SEPARATION OF INCOMPATIBLE ACTIVITIES 43
5.3.4 SECURITY 44
5.3.5 GOOD HOUSEKEEPING 44
5.4 TEST METHODS 44
5.4.1 GENERAL REQUIREMENTS 44
5.4.2 METHOD SELECTION 44
5.4.3 PAS DEVELOPED METHODS 45
5.4.4 NON-STANDARD METHODS 45
5.4.5 METHOD VALIDATION 46
5.4.6 MEASUREMENT UNCERTAINTY 48
5.4.7 CONTROL OF DATA 49
5.5 EQUIPMENT 50
5.5.1 AVAILABILITY OF EQUIPMENT 50
5.5.2 CALIBRATION 50
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5.5.3 EQUIPMENT USE AND OPERATION 51
5.5.4 EQUIPMENT IDENTIFICATION 51
5.5.5 EQUIPMENT LISTS AND RECORDS 51
5.5.6 OUT OF SERVICE PROTOCOL 52
5.5.7 CALIBRATION STATUS 52
5.5.8 RETURNED EQUIPMENT CHECKS 53
5.5.9 INTERMEDIATE EQUIPMENT CHECKS 53
5.5.10 SAFEGUARDING EQUIPMENT INTEGRITY 53
5.6 MEASUREMENT TRACEABILITY 53
5.6.1 GENERAL 53
5.6.2 EQUIPMENT CORRECTION FACTORS 54
5.6.3 SPECIFIC REQUIREMENTS 54
5.6.4 REFERENCE STANDARDS AND REFERENCE MATERIALS 54
5.7 SAMPLING 57
5.7.1 SAMPLING PLANS AND SOPS 57
5.7.2 CUSTOMER REQUESTED DEVIATIONS 57
5.7.3 RECORDKEEPING 57
5.8 SAMPLE MANAGEMENT & HANDLING 57
5.8.1 PROCEDURES 57
5.8.2 UNIQUE IDENTIFICATION 59
5.8.3 SAMPLE RECEIPT CHECKS AND SAMPLE ACCEPTANCE POLICY 59
5.8.4 SAMPLE CONTROL AND TRACKING 61
5.8.5 SAMPLE STORAGE, HANDLING, AND DISPOSAL 61
5.9 ASSURING THE QUALITY OF TEST RESULTS 62
5.9.1 QUALITY CONTROL (QC) PROCEDURES 62
5.9.2 QC CORRECTIVE ACTION 66
5.9.3 DATA REVIEW 67
5.9.4 CALIBRATION CERTIFICATES 68
5.9.5 OPINIONS AND INTERPRETATIONS 68
5.9.6 SUBCONTRACTOR REPORTS 68
5.9.7 ELECTRONIC TRANSMISSION OF RESULTS 69
5.9.8 FORMAT OF TEST REPORTS 69
5.9.9 AMENDMENTS TO TEST REPORTS 69
5.10 REPORTING 69
5.10.1 GENERAL REQUIREMENTS 69
5.10.2 TEST REPORTS: REQUIRED ITEMS 69
5.10.3 TEST REPORTS: SUPPLEMENTAL ITEMS 70
6.0 REVISION HISTORY 71
7.0 APPENDICES 74
7.1 APPENDIX A: CERTIFICATION / ACCREDITATION LISTING 74
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7.1.1 PAS-MT. JULIET 74
7.2 APPENDIX B: CAPABILITY LISTING 75
7.2.1 PAS-MT. JULIET 75
7.3 APPENDIX C: GLOSSARY 160
7.4 APPENDIX D: ORGANIZATION CHART(S) 175
7.4.1 PAS CORPORATE ORGANIZATION CHART(S) 175
7.4.2 PAS QUALITY SYSTEMS MANAGEMENT ORGANIZATION CHART 176
7.4.3 MT. JULIET – ORGANIZATION CHART 177
7.5 APPENDIX E: EQUIPMENT LISTING 182
7.5.1 PAS-MT. JULIET 182
8.0 ADDENDUM: PROGRAM REQUIREMENTS 211
8.1 DOD/DOE 211
8.2 ADDENDUM: AIHA-LAP, LLC 214
8.3 ADDENDUM: SOP REVIEW 216
8.4 ADDENDUM: RADIOLOGICAL REQUIREMENTS 217
8.4.1 ESTIMATE OF ANALYTICAL UNCERTAINTY 217
8.4.2 RADIOLOGICAL EQUIPMENT CALIBRATION 217
8.4.3 MATRIX SPIKE/MATRIX SPIKE DUPLICATE (MS/MSD) 217
8.5 ADDENDUM: QUALITY CONTROL CALCULATIONS 218
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1.0 PURPOSE AND SCOPE
1.1 Purpose
This quality manual (manual) outlines the quality management system (QMS) and management
structure of Pace® Analytical Services, LLC. Pace® Analytical Services, LLC is referred to by brand
name Pace® Analytical Services and by the acronyms PAS or ENV. The acronyms PAS and ENV
are interchangeable.
The PAS QMS is also referred to as the quality program throughout this manual and other PAS
documents. The phrases “quality management system” and “quality program” are synonymous and
are referred to by the acronym QMS.
The QMS is the collection of policies and processes established by the senior leaders of PAS (top
management) to ensure the service and products provided by PAS consistently meet relevant
requirements and achieves the goal of Pace® to provide customers with high quality, cost-effective,
analytical measurements, and services.
The QMS is also planned to establish conformance1 and compliance with the current published
versions of the following international and national quality system standards:
ISO/IEC 17025: General requirements for the competence of testing and calibration laboratories
NELAC/TNI Standard Volume 1: Management and Technical Requirements for Laboratories Performing
Environmental Analysis
1The statement of conformity to these Standards pertains only to testing and sampling activities carried out by the laboratory
at its physical address, in temporary or mobile facilities, in-network, or by laboratory personnel at a customer’s facility.
In addition to the international and national standards, the QMS is planned to achieve regulatory
compliance with the various federal and state programs for which PAS locations provide compliance
testing and/or holds certification or accreditation. Federal or state requirements that do not apply to
all PAS locations, are provided in addendum to this manual or in other documents that supplement
the manual. Customer-specific project and program requirements are not included in the manual in
order to maintain client confidentiality.
A list of accreditation and certifications held by each location associated with this manual is
provided in Appendix A.
A list of analytical testing capabilities offered by each location associated with this manual is
provided in Appendix B.
1.2 Scope and Application
This manual applies to each location listed on the Title Page of this manual, including PAS
laboratories, satellite laboratories, service centers, and supporting business functions.
For purposes of the PAS QMS:
The term “location” used in this manual refers to laboratories and/or service centers.
The term “laboratory” refers to any PAS location, however named by Pace® that provides testing,
collects samples (sampling), or conducts field measurement services in a fixed building, mobile
unit, or in-situ (field).
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The phrase “service center” refers to any PAS location, however named by Pace® that does not
perform any testing, sampling, or field measurements.
The phrase “satellite laboratory” refers to a limited-service laboratory affiliated to a larger business
unit or location. Some PAS business groups, such as accounting, may refer to a satellite laboratory
as a “service center.” Irrespective of internal jargon or reference by any group, any PAS location
that generates a test result for external use is a “laboratory” and must comply with the
requirements specified in this manual for all analytical testing services.
PAS locations are defined by physical address. Laboratories are defined by physical address and
certification/accreditation ID except mobile units which may be defined by the address of the location
to which they are assigned, by VIN (vehicle identification number), or by certification/accreditation
ID. Laboratories that provide sampling and field testing are defined by the physical address of the
PAS location to which they are affiliated and that manages these activities.
1.2.1 Quality Manual Template
This manual was prepared using the PAS Quality Manual Template (template) created by the
PAS Corporate Quality Director (CQD).
The template, known as document ID ENV-TMP-CORQ-0007, specifies the minimum
requirements that every PAS location must abide by, regardless of scope of services or number
of personnel, to maintain a quality program that achieves the objectives of the PAS Quality
Policy (See Section 4.2.2).
The template is the mechanism used by top management to communicate to PAS personnel
their commitment to continuously develop and improve the QMS for effectiveness, to meet
customer expectations, and to comply with any statutory and regulatory requirements. Their
signature of approval on this template is the mechanism used to document this responsibility.
“Top Management” is the phrase used by the TNI Standard to refer to the leaders of an
organization that develop and/or release the PAS Quality Policy Statement and QMS under
their authority
For PAS, these managers include the Chief Executive Officer (CEO) and Chief Compliance
Officer (CCO) of Pace® and the President, CQD, Senior Vice President of Operations (Sr.
VPO), and the Chief Technical Officer (CTO) of PAS.
The template and instructions for use of the template are released by corporate quality
personnel to local quality managers responsible for each location (Local QM). The local QM
uses the template to prepare the location manual by following the instructions provided to
them. The local QM may not alter the font, structure, or content of the template, except where
specified by instruction to do so. As previously stated, program specific requirements unique
to each location are provided in addendum or in documents that supplement the manual.
The template is reviewed by corporate quality personnel annually and updated, if needed. More
frequent review and revision may occur to manage change, to maintain conformance and
compliance to relevant standards or to improve the QMS.
See standard operating procedure (SOP) ENV-SOP-CORQ-00015 Document Management and
Control for more information
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1.2.2 Quality Manual
The quality manual is created from template ENV-TMP-CORQ-0007 by local quality
personnel, who are also responsible for maintenance and management of the document.
PAS locations are not permitted to alter content of the template when preparing their
manual, except where specified in the template. Control of content in the manual is
necessary to ensure consistency of implementation of the PAS quality program across the
network.
If additions or changes to the manual are needed to maintain regulatory compliance or
conformance to relevant standards and these changes cannot be covered by addendum to
the manual, the need for change must be raised to the PAS Corporate Quality Director,
who will decide how to resolve the need.
The manual is approved for release by the management team listed on the Quality Manual
Approval Signatory Page. The manager’s electronic signature on the Title Page of the manual
affirms their commitment to implement and uphold the requirements, processes, and
procedures of the PAS QMS at each location for which the manual was prepared.
The manual is reviewed annually and updated with each release of a new version of the
template, and as needed to update appendices and addendum. More frequent review and
revision may be necessary when there are significant changes to the capabilities, and resources
of the laboratory during the calendar year
See SOP ENV-SOP-CORQ-00015 Document Management and Control for more information.
1.2.3 References to Supporting Documents
The template and the manual include references to other organization documents that support
the QMS such as policies and standard operating procedures (SOPs).
These references may include the document’s document control number (DC#) and the
document title. This information is subject to change at the discretion of PAS. The manual
and/or template are updated to reflect the editorial change during the manual’s next scheduled
review/revision cycle or the next time a version of the manual is released, whichever is sooner.
Each location maintains a current list of documents used by the location to support the QMS.
This list, known as the “Master List”, is readily available to personnel for their use and it
provides a cross reference to the legacy document ID, where applicable. Parties external to
PAS may contact the location of interest to obtain the most current version of the Master List
for their use as needed.
2.0 REFERENCES
References used to prepare this manual include:
“Guidelines Establishing Test Procedures for the Analysis of Pollutants Under the Clean Water Act.”
Federal Register, 40 CFR Part 136, most current version.
“Test Methods for Evaluating Solid Wastes: Physical/Chemical Methods.” SW-846.
“Methods for Chemical Analysis of Water and Wastes,” EPA 600-4-79-020, 1979 Revised 1983, U.S.
EPA.
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U.S. EPA Contract Laboratory Program Statement of Work for Organic Analysis, current version.
U.S. EPA Contract Laboratory Program Statement of Work for Inorganic Analysis, current version.
“Standard Methods for the Examination of Water and Wastewater.” Current Edition APHA-AWWA-
WPCF.
“Annual Book of ASTM Standards,” Section 4: Construction, Volume 04.04: Soil and Rock; Building
Stones, American Society of Testing and Materials.
“Annual Book of ASTM Standards,” Section 11: Water and Environmental Technology, American
Society of Testing and Materials.
“NIOSH Manual of Analytical Methods,” U.S. Department of Health and Human Services, National
Institute for Occupational Safety and Health, most current version.
“Methods for the Determination of Organic Compounds in Finished Drinking Water and Raw Source
Water,” U.S. EPA, Environmental Monitoring and Support Laboratory – Cincinnati (Sep 1986).
Quality Assurance of Chemical Measurements, Taylor, John K.; Lewis Publishers, Inc. 1987.
Methods for Non-conventional Pesticides Chemicals Analysis of Industrial and Municipal Wastewater,
Test Methods, EPA-440/1-83/079C.
Environmental Measurements Laboratory (EML) Procedures Manual, HASL-300, US DOE, February
1992.
Requirements for Quality Control of Analytical Data, HAZWRAP, DOE/HWP-65/R1, July 1990.
Quality Assurance Manual for Industrial Hygiene Chemistry, AIHA, most current version.
National Environmental Laboratory Accreditation Conference (NELAC) Standard- most current
version.
ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories, 2nd
Edition 2005-05-15; 3rd Edition 2017-11
The following are implemented by normative reference to ISO/IEC 17025:
o ISO/IEC Guide 99, International vocabulary of metrology –Basic and general concepts and associated terms
o ISO/IEC 17000, Conformity assessment – Vocabulary and general principles
Department of Defense Quality Systems Manual (QSM), most current version.
TNI (The NELAC Institute) Standard, 2009 and 2016 versions.
UCMR Laboratory Approval Requirements and Information Document, most current version.
US EPA Drinking Water Manual, most current version.
3.0 TERMS AND DEFINITIONS
Refer to Appendix C for terms, acronyms, and definitions used in this manual and in other documents
used by PAS to support the QMS.
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4.0 MANAGEMENT REQUIREMENTS
4.1 Organization
4.1.1 Legal Identity
Pace® Analytical Services, LLC (Pace® Analytical Services) is the responsible entity
authorized by the State of Minnesota to do business as a limited liability company, under the
parent company, PAS Parent, Inc.
4.1.1.1 Change of Ownership
If there is a change of ownership, if a location goes out of business, or if the entire
organization ceases to exist, PAS management is responsible to notify regulatory
authorities of the change within the timeframe required by each state agency for which
the location is certified or accredited.
Requirements for records and other business information are addressed in the
ownership transfer agreement or in accordance with appropriate regulatory
requirements, whichever takes precedence.
4.1.2 Compliance Responsibility
PAS management has the responsibility and authority to establish and implement procedures
and to maintain resources necessary to assure its activities are carried out in such a way to meet
the federal and statutory requirements in addition to the requirements of the PAS QMS. Also
See Section 1.1.
4.1.3 Scope of the Quality Management System
The QMS applies to work carried out at each location covered by this manual including
permanent facilities, at sites away from its permanent facilities, or in associated temporary or
mobile facilities.
The permanent and mobile facilities to which this manual applies are listed on the Title Page
of this manual.
4.1.4 Organization History and Information
Founded in 1978, Pace® Analytical Services, LLC (PAS) is a privately held scientific services
firm operating one of the largest full-service contract laboratory and service center networks
in the United States.
The business purpose of PAS is to deliver the highest standard of testing and scientific services
in the market. We offer the most advanced solutions in the industry, backed by transparent
data, a highly trained team, and the service and support that comes from over four decades of
experience.
4.1.4.1 Organization Structure
Each PAS location is led by a management team referred to as local management1.
Local management is responsible for making day-to-day decisions regarding the
operations of the facility and implementing, and sustaining the requirements, policies,
and procedures of the PAS quality program.
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The roles that make up the local management team include a Vice President of
Operations (VPO), a General Manager (GM) or Director of Laboratory Operations
(DLO), a Quality Program Manager (QPM), and the Quality Manager (QM).
1 The term “local management” does not mean “on-site” management. Some of the
roles that make up the local management team, work off site or from a different PAS
location. Refer to the Quality Manual Approval page at the beginning of this manual
for the physical address of each manager that comprises the local management team.
The local management team is supported by department specific supervisors and in
some PAS locations, a site supervisor or operations manager.
Local management and supervisors are supported by personnel from functional
groups that support the division, such as HR, IT, Sales & Marketing, Finance, and
EHS (Environmental Health & Safety).
Technical oversight for each location is provided by local personnel with support and
guidance from the PAS Chief Technical Officer (CTO), PAS corporate quality
personnel, and the Pace® compliance team. Locations that hold TNI accreditation,
also have personnel appointed to serve as the “acting technical manager for TNI,
however named” to perform the duties and responsibilities of this designation per the
TNI Standard. See Section 4.1.5.2.1 for more information on this TNI requirement.
The reporting relationships and responsibilities of quality personnel are independent
of operations in order to safeguard impartiality. See Section 4.1.5.2 for more
information.
Refer to the organization charts provided in Appendix D to view the organization
structure, reporting relationships, and the interrelationships between positions.
4.1.5 Management Requirements
4.1.5.1 Personnel
Each PAS location is staffed with administrative and/or technical personnel who
perform and verify work under the supervision of their direct line supervisor.
All personnel are expected to perform their duties in accordance with the policies and
processes outlined in this manual and in accordance with standard operating
procedures (SOPs) and other quality system documents. PAS policies and procedures
are designed for impartiality and integrity. When these procedures are fully
implemented, personnel remain free from undue pressure and other influences that
adversely impact the quality of their work or data.
4.1.5.1.1 Key Personnel
Key personnel are management positions that have the authority and
responsibility to plan, direct, and control activities related to the
QMS for the entire division (PAS Corporate), or for one or more
PAS locations (Local).
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PAS Key Personnel Positions & Deputy Assignments by Role
Job Title Acronym Primary / Alternate Deputy
Chief Executive Officer CEO President
Chief Compliance Officer CCO CQD
President NA CEO / Sr. VPO
Corporate Quality Director CQD CCO
Quality Program Manager QPM CQD / Peer QPM
Chief Technical Officer CTO CQD / CCO
Sr. VP of Operations Sr. VPO President / VPO
Vice President of Operations VPO Sr. VPO / Peer VPO
Director of Lab Operations1 DLO VPO / Peer GM or Sr. VPO
Health and Safety Director NA CCO
IT Director NA CTO
Quality Manager QM Direct QPM / Peer QPM
General Manager1 GM VPO / Sr. VPO or Peer GM
Operations Manager1 OM GM / DL or VPO
Technical Manager1 TM CTO / Peer TM
TNI Approved TM2 TNI TM Another Qualified Employee
1:Position is not in place at all locations.
2: The TNI TM is not a PAS position. See Section 4.1.5.2.1 for more information.
Some certification and accreditation programs require notification
when there is a change in key personnel. Notification requirements
and timeframes by agency, are tracked and upheld by the local QM,
when these requirements apply.
4.1.5.2 Roles and Responsibilities
The qualifications, duties, and responsibilities for each position at Pace® are detailed
in job descriptions maintained by the Pace® Human Resource personnel (HR).
The following sections provide a general overview of various management and
supervisory roles and are presented in no particular order.
Chief Executive Officer (CEO): Provides leadership for overall operations;
oversight of regulatory and compliance standards; development of growth strategies;
and long-range capital and strategic planning for Pace®.
Chief Compliance Officer (CCO): Has overall responsibility for statutory and
regulatory compliance and the environmental health and safety programs (EHS) for
Pace®.
President: Provides leadership for overall operations; oversight of regulatory and
compliance standards; development of growth strategies; and long-range capital and
strategic planning for PAS.
Chief Technical Officer (CTO): Provides technical oversight and leadership to all
PAS locations. Responsible for innovation and standardization of technical activities.
Corporate Director of Quality (CQD): Responsible for developing the PAS quality
program and the policies and procedures that support the QMS. The CQD leads the
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quality team, establishing functions, responsibilities, duties, and organization structure
for PAS.
Corporate Quality Program Manager (QPM): Responsible for helping local
management implement, monitor, maintain and improve the PAS quality program for
one or more locations in the network and for direct supervision of Quality
Manager(s).
Director of Information Technology: Oversees and delivers the systems and
processes of information technology used by PAS. These systems include Laboratory
Information Management Systems (LIMS); data acquisition, reduction, and reporting
software; virus-protection, communication tools, and ensuring the integrity, security
of electronic data, and associated policies and procedures.
Sr. Vice President of Operations (Sr VPO): Provides leadership, direction, and
insight necessary to achieve strategic initiatives. Develops and improves processes,
structure, and allocation of resources for operations for all of PAS.
Vice-President of Operations (VPO): Provides leadership, guidance, and
resources, including allocation of personnel, necessary to achieve the strategic goals
of the organization and the PAS quality program to one or more PAS locations.
Director of Laboratory Operations (DLO): See description for General Manager.
General Manager (GM): The GM is responsible for overall administration and
operation of one or more PAS locations and service centers. Although task duties
associated with this responsibility may be delegated, the GM is responsible for
ensuring all duties and activities of the locations they oversee comply with the PAS
QMS, the PAS EHS program, and with any applicable statutory, regulatory
requirements or program requirements.
Any GM of a NELAC/TNI Accredited laboratory is also responsible for the
designation of technical personnel to serve as acting technical managers for TNI for
the fields of accreditation held by the laboratory (See Section 4.1.5.2.1) and for
notifying the accreditation body (AB) of any extended absence or reassignment of
these designations.
Quality Manager (QM): The QM oversees and monitors the implementation,
compliance, and improvement of the QMS and communicates gaps, deviations, and
opportunities for improvement to local and corporate laboratory management. The
QM is independent of the operation and analytical activities for which they provide
oversight and has the authority to carry out the roles and responsibilities of their
position without outside influence.
The QM:
serves as the focal point for QA/QC protocol decisions and oversees review of
QC data for trend analysis;
evaluates data objectively and performs assessments without outside influence;
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has documented training and experience in QA/QC procedures and the PAS
quality system;
has a general knowledge of the analytical methods offered by the laboratory;
coordinates and conducts internal systems and technical audits;
notifies laboratory management of deficiencies in the quality system;
monitors corrective actions;
provides support to technical personnel and may serve as the primary deputy for
the acting TNI Technical Manager(s).
Manager-Client Services (CSM): This position is responsible for the training and
supervision of project manager(s) and/or shipping, receiving and courier personnel.
The primary responsibility of the CSM is to ensure projects are successfully managed
to meet the expectations and needs of PAS customers.
Department Managers / Supervisors / Team Lead): These positions are
responsible for administrative and operations management and implementation of
the QMS in the work area he/she oversees. These responsibilities include but are not
limited to: training and supervision of personnel, monitoring work activity to maintain
compliance with this manual, SOPs, policies and other instructional documents that
support the QMS; method development, validation and the establishment and
implementation of SOPs to assure regulatory compliance and suitability for the
intended purpose; monitoring QA/QC performance, proper handling and reporting
of nonconforming work, purchasing of supplies and equipment adequate for use,
maintaining instrumentation and equipment in proper working order and calibration,
and general maintenance of administrative and technical processes and procedures
established by the laboratory.
Operations Manager (OM): The OM is responsible for management of production
and/or other duties assigned by the GM.
4.1.5.2.1 Approved Technical Manager (TNI Accreditation Only):
The requirements in this subsection apply to only to PAS locations
that are NELAC/TNI accredited.
The TNI Standard specifies requirements for the qualification and
duties of technical personnel. The TNI Standard lists these duties
under the reference “technical manager(s), however named.”
At PAS, these duties closely correlate with the responsibilities and
duties outlined in the PAS job descriptions for managers,
supervisors, team leads, and/or scientist. However, these duties do
not need to be associated with any specific job title and can be
assigned to any one or more PAS employees that meets the
qualifications specified in the TNI Standard.
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Refer to the applicable version of the TNI Standard to view the
required qualifications for each discipline.
PAS locations that are TNI accredited must designate one or more
employees to perform these duties and submit these qualifications
to the TNI accreditation body (AB) for approval.
Employees approved by the TNI AB, to perform these duties retain
their Pace® assigned job title.
When TNI Accreditation Bodies (AB) refer to these employees as
‘technical manager’ or ‘technical director’ on the official certificate
or the scope of accreditation, this reference is referring to their
approval to perform duties of the ‘technical manager, however
named’ as specified in the TNI Standard and not to a PAS job title.
The duties of any approved technical manager for TNI, however
named, can be completed in person or remotely. If an employee that
is an approved technical manager for TNI is completely absent from
work or on a leave of absence for more than 15 calendar days, the
duties and responsibilities specified in the TNI Standard are
temporarily reassigned to another employee that meets the
qualifications for the technology or field of accreditation. If the
employee’s absence exceeds 35 calendar days, the local QM must
formally notify the TNI primary AB of the absence and the details
of reassignment of duties in writing.
4.1.5.3 Conflict of Interest
A conflict of interest is a situation where a person has competing interests that may
affect impartiality. It is the policy of Pace® to ensure business relationships, decisions
and transactions do not place personal interest ahead of the organization, customers,
colleagues, job responsibilities or the public we serve. Conflict of interest is avoided
by making personnel aware of circumstances that conflict or appear to conflict with
impartiality and/or designing process and procedures to include checks and balances
to prevent conflict and ensure impartiality.
See the current version of policy COR-POL-0004 Code of Ethics and Professional Conduct
for more information.
4.1.5.4 Confidentiality
PAS management is committed to preserving the confidentiality of Pace® customers
and confidentiality of Pace® business information.
Client information obtained or created during work activities is considered
confidential and is protected from intentional release to any person or entity other
than the client or the client’s authorized representative, except when Pace® is
required by law to release confidential information to another party, such as a
regulatory agency or for litigation purposes. In which case, Pace® will notify the client
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of the release of information and the information provided, unless notification is
prohibited by law.
When Pace® obtains information about the customer from a source other than the
customer, Pace® will keep the source of the information confidential unless
disclosure is agreed upon by the source.
The terms of client confidentiality are included in PAS Standard Terms and
Conditions (T&C). With the acceptance of the T&C and/or the implicit contract for
analytical services that occurs when the client sends samples to PAS for testing, the
client authorizes Pace® to release confidential information when required. Other
procedures used by PAS to maintain confidentiality include:
A Code of Ethics and Professional Conduct policy that covers this topic (COR-
POL-0004):
A Confidentiality Agreement which supervisory and sales personnel and other
positions are required to sign at the time of employment and abide by the
conditions of throughout employment;
Record retention and disposal procedures that assure confidentiality is
maintained;
Physical access controls and encryption of electronic data; and
See policy COR-POL-0004 Code of Ethics and Professional Conduct for more information.
4.1.5.5 Communication
Communication is defined as the imparting or exchanging of news and information.
Effective (good) communication occurs when the people included in the
communication gets the point and understands it.
4.1.5.5.1 Workplace Communication
Effective communication in the workplace is necessary to assure
work is performed correctly, efficiently, and in accordance with
client specifications.
Instructions for how to conduct testing and other work activities are
communicated to personnel via written policies, standard operating
procedures, and other work instructions.
Information about PAS performance (positive and negative) and
ideas for improvement are communicated to personnel using various
communication channels such as face to face meetings, video
conferencing, conference calls, email, memoranda, written reports,
and posters.
4.1.5.5.2 External Communication
Communication with external parties such as customers, vendors,
business partners, and regulatory agencies takes place every day.
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PAS management is responsible for training personnel to
communicate in professional and respectful ways to build strong
relationships and to avoid misunderstanding.
4.2 Quality Management System
4.2.1 Quality Management System Objectives
The objectives of the PAS QMS are to provide clients with consistent, exemplary professional
service, and objective work product that is of known and documented quality that meets their
requirements for data usability and regulatory compliance.
Objective work product is analytical services, data, test results, and information that is not
influenced by personal feeling or opinions. The quality of being objective is also known as
‘impartiality.’
4.2.1.1 Impartiality
PAS achieves and maintains impartiality by establishing an organizational structure
that safeguards impartiality (See 4.1.4.1) and implementing and adhering to the
policies and processes of the QMS outlined in this manual, which are based on
industry accepted standards and methodologies.
PAS procedures for handling nonconforming work (See 4.9), corrective and
preventive actions (See 4.11, 4.12) and management review (See 4.15) are the primary
mechanisms used to identify risk to impartiality and to prompt actions necessary to
eliminate or reduce the threat when risk to impartiality is suspected or confirmed.
4.2.1.2 Risk and Opportunity Assessment
Risks are variables that make achieving the goals and objectives of the QMS uncertain.
An opportunity is something that has potential positive consequences for the
organization.
PAS personnel manage risks and opportunities on a daily basis by following policies,
procedures and processes that support the QMS. Some ways in which the QMS is
designed to identify, minimize, or eliminate risk on a daily basis include but are not
limited to:
Capability and capacity reviews of each analytical service request to assure the
laboratory can meet the customer’s requirements;
Maintenance of accreditation and certification for test methods in multiple states
and programs to cover a broad range of jurisdiction for regulatory compliance;
SOPs and other controlled instructional documents are provided to personnel to
eliminate variability in the process. These documents include actions to counter
risk factors inherent in the process and are reviewed on a regular basis for on-
going suitability and relevancy;
Participation in proficiency testing programs and auditing activities to verify on-
going competency and comparability in performance;
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Provision of on-the-job training and established protocol for quality control (QC)
corrective action for nonconforming events;
An established program for ethics, and data integrity;
Tiered data review process;
Culture of continuous improvement;
Monitoring activities to assess daily and long-term performance; and
Annual critical review of the effectiveness of the QMS.
PAS also promotes a continuous improvement culture based on the principles of lean
manufacturing. These principles include 3P (Process, Productivity, Performance) and
Kaizen. 3P is a platform used by PAS to share best practices and standardization
across the network to achieve operational excellence. Kaizen is a team-based process
used to implement tools and philosophies of lean to reduce waste and achieve flow
with the purpose of improving both external and internal customer satisfaction. The
PAS lean program and activities help to mitigate risk because they generate a collective
understanding of vulnerabilities and utilize group-effort to develop and implement
solutions at all levels.
Risk and opportunities may also be formally identified using specific risk and
opportunity assessment methods such as SWOT Analysis (Strength, Weakness,
Opportunity, Threats) and 3-Stage Impact/Probability Grids.
4.2.1.3 Communication of the Quality Management System
This manual is the primary mechanism used by PAS management to communicate
the QMS to personnel.
To assure personnel understand and implement the quality program outlined in the
manual:
PAS personnel are required to sign a Read and Acknowledgement Statement to
confirm the employee has:
1) been informed of the manual by management,
2) has access to the manual,
3) has read the manual
4) understands the content of the manual, and
5) agrees to abide by the requirements, policies, and procedures therein.
Personnel are informed that the manual provides the “what” of the QMS. The
“how to” implementation of the QMS is provided in policy, SOPs, standard work
instructions, and other instructional documents.
This manual and supporting policies and procedures are made readily accessible
to personnel in the area where the work activity is performed.
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4.2.2 Quality Policy Statement
The quality policy of PAS is to provide customers with data of known and
documented quality fit for their intended purpose. PAS achieves this policy by
implementing the QMS defined in this manual, by following industry accepted
protocol for analytical testing and quality assurance and quality control (QA/QC)
activities, by conformance with published and industry accepted testing
methodologies, and by compliance with international and national standards for the
competency and/or accreditation of testing laboratories.
Intrinsic to this policy statement is each of the following principles:
PAS will provide customers with reliable, consistent, and professional service.
This is accomplished by making sure each PAS location has the resources
necessary to maintain capability and capacity; that staff are trained and competent
to perform the tasks they are assigned; that client-facing staff are trained and
prepared to find solutions to problems and to assist customers with their needs
for analytical services. Customer feedback, both positive and negative, is shared
with personnel and used to identify opportunities for improvement.
PAS maintains a quality program that complies with applicable state, federal, and
industry standards for analytical testing and competency.
PAS management provides training to personnel so that all personnel are familiar
with the QMS outlined in this manual and that they understand that
implementation of the QMS is achieved by adherence to the Pace® and PAS
policies and procedures.
PAS management continuously evaluates and improves the effectiveness of the
QMS by responding to customer feedback, and other measures of performance,
such as but not limited to the results of internal/external audits, proficiency
testing, metrics, trend reports, and annual and periodic management reviews.
4.2.2.1 Ethics Policy / Data Integrity Program
Pace® has established a comprehensive ethics and data integrity program that is
communicated to all Pace® employees so that they understand what is expected of
them. The program is designed to promote a mindset of ethical behavior and
professional conduct that is applied to all work activities.
The key elements of the Pace® Ethics / Data Integrity Program include:
Ethics Policy (COR-POL-0004);
Ethics Officer (Chief Compliance Officer);
Standardized data integrity training course taken by all new employees on hire
and a yearly refresher data integrity training course for all existing employees;
Policy Acknowledgement Statements that all Pace® personnel, including contract
and temporary, are required to sign at the time of employment and again during
annual refresher training to document the employee’s commitment and
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obligation to abide by the company’s standards for ethics, data integrity and
confidentiality;
SOPs that provide instructions for how to carry out a test method or process to
assure tasks are done correctly and consistently by each employee;
On the Job Training;
Data integrity monitoring activities which include, but are not limited to, primary,
secondary and completeness data reviews, internal technical and system audits,
data audits, data surveillance, and proficiency testing; and
Confidential reporting process for alleged ethics and data integrity issues.
All PAS managers and supervisors are expected to provide a work environment where
personnel feel safe and can report unethical or improper behavior in complete
confidence without fear of retaliation. Retaliation against any employee that reports a
concern is not tolerated.
Pace® has engaged Lighthouse Services, Inc. to provide personnel with an
anonymous reporting process available to them 24 hours a day/7 days per week. The
alert line may be used by any employee to report potential violations of the company’s
ethics and data integrity program. Reports are forwarded to the Pace® Ethics
Compliance Officer to investigate and resolve the matter. Investigations concerning
data integrity are kept confidential.
See COR-POL-0001 Compliance Alertline for more information.
Posters and flyers with the compliance alert line information must be prominently
posted in each PAS location for personnel reference.
Compliance Alert Line Information:
English Speaking US & Canada [phone]
Spanish Speaking North America [phone]
Internet www/lighthouse-services.com/pacelabs
Email [e-mail]
4.2.3 Management Commitment: Quality Management System
Evidence of management’s commitment for the development, maintenance, and on-going
improvement of the QMS is provided by the application of their signature of approval to the
template and/or manual. Their signature confirms they understand their responsibility to
implement the QMS outlined in this manual, to communicate the quality program to
personnel, and to uphold requirements of the program during work activities.
4.2.4 Management Commitment: Customer Service
Management communicates the importance of meeting customer and regulatory requirements
to personnel by training personnel on the QMS outlined in this manual, implementing the
QMS outlined in this manual, and upholding these requirements for all work activities.
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4.2.5 Supporting Procedures
References to processes and procedures that support the QMS are included throughout this
manual. The structure of the document management system is outlined in SOP ENV-SOP-
CORQ-0015 Document Management and Control and summarized in the following subsections.
4.2.5.1 Quality Management System Document Structure
Documents associated with the QMS are classified into document types that identify
the purpose of the document and establish how the document is managed and /or
controlled.
Examples: Types of PAS Internally Created Documents
Document Type Purpose
Quality Manual Outlines the PAS QMS and structure and how it works for a system
including policy, goals, objectives and detailed explanation of the system and
the requirements for implementation of system. Includes roles and
responsibilities, relationships, procedures, systems, and other information
necessary to meet the objectives of the system described.
Policy Provide requirements and rules for a process and is used to set course of
actions and to guide and influence decisions. Policy describes the “what,”
not the “how”.
Standard Operating
Procedure
Provide written and consistent set of instructions or steps for execution of a
routine process, method, or set of tasks performed. Assures that activities
are performed properly in accordance with applicable requirements.
Standard Work
Instruction
Provide step by step visual and/or written instruction to perform a specific
task to improve competency, minimize variability, reduce work injury and
strain, or to boost efficiency and quality of work (performance). SWI are
associated with an SOP unless the task described is unrelated to generation
of or contribution to environmental data or analytical results.
Template Pre-formatted document that serves as a starting point for a new document.
Guide Assists users in using a particular product; or a technical interpretation of a
method or process by which PAS locations must abide.
Form Used for a variety of purposes such as to provide a standardized format to
record observations, to provide information to supplement an SOP.
Guidance Non-binding advice used to explain internal policies, procedures, or
practices.
Example: Types of External Documents used by PAS
Certificate Lists parameters, methods, and matrices for which the location is
certified/accredited to perform within the jurisdiction of the issuing
regulatory agency or accreditation body.
Reference
Document
Provide information, protocol, instructions, and/or requirements. Issued by
the specifier. Examples include ISO/IEC, TNI, DoD and published
referenced methods such as Standard Methods, ASTM, SW846, EPA, and
federal and state regulatory bodies.
Project Document Provides requirements necessary to meet individual client expectations for
intended use of data. Examples include project quality assurance plans
(QAPP), client-program technical specifications, contracts, and other
agreements.
These document types are ranked to establish which documents takes precedence
when there is an actual or perceived conflict between documents and to establish the
hierarchal relationships between documents. The ranking system also provides
information to document writers and reviewers to assure downline documents agree
with documents of higher rank.
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PAS Document Hierarchy
Rank Document
1 Corporate Manual
2 Corporate Policy
3 Corporate SOP
4 Corporate SWI, Templates, Guides, Forms, Guidance
5 Local Manual
6 Local SOP
7 Local SWI, Templates, Guide, Forms, Guidance
Information and requirements from project documents are not incorporated into PAS
policy or SOPs in order to maintain client confidentiality. These documents are
managed as external documents and any requirements for work specified is followed
when work for the project is performed. Project Documents are reviewed and
maintained as part of the contract/incoming work review process (See Section 4.4).
If the project document is less stringent than the PAS QMS, policies, or SOPs, and/or
is less stringent than applicable federal or state requirements, PAS locations are still
required to meet the minimum requirements of the PAS QMS and any applicable
statutory or federal requirements in addition to the requirements specified in the
project document.
Reference documents are not ranked because all PAS created documents, processes
and procedures must be consistent with the applicable reference document(s) in
addition to higher-ranking PAS documents.
See SOP ENV-SOP-CORQ-0015 Document Management and Control for more
information.
4.2.6 Roles and Responsibilities
The roles and responsibilities for technical management and the quality manager is provided
in section 4.1.5.2.
4.2.7 Change Management
When significant changes to the PAS QMS are planned, these changes are managed by
corporate quality personnel to assure that the integrity of the QMS is maintained.
4.3 Document Control
4.3.1 General
PAS procedures for document control are provided in SOP ENV-SOP-CORQ-0015 Document
Management and Control.
PAS locations use electronic document management software (eDMS) to perform the
document control procedures of the SOP. This system provides centralized access to all
documents used by PAS locations across the network. All PAS locations are required to use
the eDMS system established for PAS (presently Qualtrax) unless an exemption has been
granted by the PAS Corporate Quality Director.
eDMS automates the process for unique document identification, version control, approval,
access, and archival and restricts access to archived documents except to authorized users to
prevent the use of obsolete documents.
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The local QM maintains a master list of controlled documents used at each location. The
master list minimally includes the document control number, document title, and current
revision status and is made available to personnel for their reference.
See SOP ENV-SOP-CORQ-0015 Document Management and Control for more information.
4.3.2 Document Approval and Issue
Documents that support the QMS are reviewed by qualified personnel and approved by
management prior to release for use.
Only the approved versions of documents are available to personnel for use unless use of a
draft document is authorized by management.
The managers responsible for authorization of each document is situation specific.
See SOP ENV-SOP-CORQ-0015 Document Management and Control for more information.
4.3.3 Document Review and Change
Unless a more frequent review is required by regulatory, certification or accreditation program
documents are reviewed at least every two years to ensure the documents remains current,
appropriate, and relevant.
Documents are also informally reviewed every time the document is used. Personnel are
expected to refer to and follow instructions in controlled documents when they conduct their
work activities. Consequently, any concerns or problems with the document should be caught
and brought to the attention of management on an on-going basis.
Documents are revised whenever necessary to ensure the document remains usable and
correct. Older document versions and documents no longer needed are made obsolete and
archived for historical purposes.
PAS does not allow hand-edits to documents. If an interim change is needed pending re-issue
of the document, the interim change is communicated to those that use the document using a
formal communication channel, such as change in progress form, email, or memorandum.
The document review, revision, and archival process is managed by quality personnel at the
location from which the document was released using the procedures established in SOP
ENV-SOP-CORQ-0015 Document Management and Control.
4.4 Analytical Service Request, Tender, and Contract Review
PAS management and/or client service personnel perform thorough reviews of requests and contracts
for analytical services to verify the location(s) performing the work has the capability, capacity, and
resources necessary to successfully meet the customer’s needs. These review procedures are described
in SOP ENV-SOP-MTJL-0009, Contract Review.
The procedures in this SOP(s) are established to ensure that:
The PAS locations performing the work understand the purpose of data collection in order to
ensure the test methods requested are appropriate for the intended use of the data and capable
of meeting the client’s data quality objectives;
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 PAS locations and any external subcontractor(s) have the capability, capacity, and resources to
meet the project requirements and expectations within the requested time frame for delivery of
work product;
Any concerns that arise from review are discussed and resolved with the client;
Any discrepancies between the PAS QMS, statutory or regulatory requirements and the client
request are resolved; and
The results of review and any correspondence with the client related to this process and/or any
changes made to the contract are recorded and retained for historical purposes.
Capability review confirms that the PAS locations contracted to perform the work and any internal
or external subcontractors hold required certification/accreditation for the test method, matrix, and
analyte and verifies the location can achieve the client’s target compound list and data quality
objectives (DQOs) for analytical sensitivity and reporting limits, QA/QC protocol, and hardcopy test
report and electronic data deliverable (EDD) formats.
Capacity review verifies that the in-network locations and any potential subcontractors are able to
manage the sample load and deliver work production within the delivery timeframe requested.
Resource review verifies that the location and any potential subcontractors have adequate qualified
personnel with the skills and competency to perform the test methods and services requested and
sufficient and proper equipment and instrumentation needed to perform the services requested.
4.5 Subcontracting (Internal and External)
The terms ‘subcontract’ and “subcontracting” refers to analytical work done by an organization
external to Pace® (External Subcontracting) or by a Pace® location with an address different than
the address listed on the cover page of the test report (Internal Subcontracting).
The PAS network offers comprehensive analytical capability and capacity to ensure Pace® can meet
a diverse range of client needs for any type of project. If a PAS laboratory receives a request for
analytical services and it cannot fulfill the project specifications, the location’s client services team will
collaborate with the client to place the work within the PAS network.
When it is not possible to place the work within network, the location will, with documented client
approval, subcontract the work to a subcontractor that has the capabilities to meet the project
specifications and can meet the same commitment agreed on between the location and the client.
Whenever work is subcontracted, the PAS location responsible for management of the project verifies
each of these qualifications:
The internal or external subcontractor has the proper accreditation/certifications required for the
project and these are current; and
The use of the internal or external subcontractor is approved by the client and/or regulatory
agency when such approval is required by the customer. Record of customer approval is retained
in the project record.
External subcontractors selected by Pace® must be pre-qualified by quality personnel to verify their
QMS is similar to Pace® and complies with all relevant Standards such, as ISO/IEC 17025 and the
TNI Standard(s) and/or federal and state regulatory requirements. The list of approved
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subcontractors for each location is maintained by local quality personnel. Pre-qualification of a
subcontractor does not eliminate the requirement for the PAS location placing work to verify the
subcontractor has the certifications, capability, capacity, and resources to perform work on behalf of
Pace® on a project-specific basis.
For all subcontracted work, the PAS location placing the work internally or externally is responsible
to ensure project specifications are always communicated to and understood by the subcontractor.
4.6 Purchasing Services and Supplies
Vendors that provide services and supplies to PAS are qualified to meet the needs of Pace®. These
needs include but are not limited to competitive pricing, capacity to fill purchase orders, quality of
product, customer service, and business reputation and stability. Evidence of this qualification is the
availability to purchase services and supplies from the vendor in the corporate purchasing system.
PAS locations may purchase goods and services from any supplier in the purchasing system.
The specifications (type, class, grade, tolerance, purity, etc.) of supplies, equipment, reagents, standard
reference materials and other consumables used in the testing process are specified in SOPs. The SOP
specifications are based on the governing requirements of the approved reference methods and any
additional program driven regulatory specification, such as drinking water compliance.
All requisitions for materials and consumables are approved by local management who is responsible
to ensure the services and supplies procured and received are fit for intended use.
4.7 Customer Service
Project details and management is managed by PAS client services personnel.
4.7.1 Commitment to Meet Customer Expectations
PAS personnel collaborate closely with our customers to ensure their needs are met and to
establish their confidence in the capability of PAS to meet their needs for analytical services
and expectations for service.
The project manager (PM) is the customer’s primary point of contact for each analytical service
request (work order). The PM gathers information from the customer to ensure the details of
their request are understood. After samples are received, the PM monitors the progress of the
project and alerts the customer of any delays or excursions that may adversely impact data
usability. Supervisors are expected to keep the PM informed of project status and any delays
or key issues, so that the PM can keep the client informed.
PAS encourages customers to visit our locations to learn more about the capabilities, observe
performance and to meet personnel.
PAS customers expect confidentiality. Personnel will not divulge or release information to a
third party without proper authorization unless the information is required for litigation
purposes. See Section 4.1.5.4 of this manual and policy COR-POL-0004 Code of Ethics and
Professional Conduct for more information on the policy for client confidentiality.
4.7.2 Customer Feedback
PAS actively seeks positive and negative feedback from customers through surveys and direct
communication. Information from the client about their experience working with PAS and
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their satisfaction with work product is used to enhance processes and practices and to improve
decision making. Customer feedback is reviewed to identify risk and opportunity. Corrective,
preventive, or continuous improvement actions are taken based on nature of and/or feedback
trends.
Also see sections 4.9, 4.10, 4.11, 4.12, 4.14, and 4.15 for more information about how customer
feedback is managed by PAS and used to enhance the QMS.
4.8 Complaints
A complaint is a formal expression of dissatisfaction with the performance of a service or product
originating from a party external to Pace®. Complaints provide opportunities to improve processes
and/or build stronger working relationships with clients.
The PAS complaint resolution process depends on the situation and the nature of the complaint.
Each complaint received is reviewed to determine if it is valid. If the complaint is valid, it is either
addressed immediately by the person receiving the complaint or the nature of the complaint is further
reviewed and investigated prior to resolution and follow up with the customer.
Complaints (and compliments) are recorded and reviewed during Annual Management Review (See
Section 4.15).
4.9 Nonconforming Work
4.9.1 Definition of Nonconforming Work
Nonconforming work is work that does not conform to customer requirements, standard
specifications, policies, and procedures, or that does not meet acceptance criteria.
The discovery of non-conforming work comes from various sources which include, but are
not limited to:
results of quality control samples and instrument calibrations;
quality checks on consumables and materials;
general observations of personnel;
data review;
proficiency testing;
internal and external audits;
complaints and feedback;
management review and reports; and
regulatory and certification and accreditation actions.
The way in which the laboratory or service center manages nonconforming work depends on
the significance and impact (risk) of the issue. Some issues may simply require correction,
others may require investigation, corrective action (See 4.11) and/or data recall (See 4.16).
When the location releases data and test results associated with nonconforming QC and
acceptance criteria, test results are qualified, or non-conformances are noted in the final
analytical report to apprise the data user of the situation. (See 5.10)
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Nonconforming work also includes unauthorized departure from l policies, procedures, and
test methods. Authorized departures are explained in the following subsections. Situations that
do not conform to these conditions are considered unauthorized departure(s).
4.9.1.1 Authorized Departure from SOPs
Departures from an SOP may sometimes be necessary to correct for an error in an
SOP or to resolve a complex problem. For example, to mitigate a complex matrix
interference.
An authorized departure from a test method SOP is one that has been reviewed and
approved by the department leader, however named, of the work area in which the
test method is performed. The leader, when authorizing a departure from an SOP,
accepts full responsibility to ensure the departure does not conflict with Pace® or
PAS policy or procedure, does not affect statutory, regulatory or program compliance
and does not adversely affect data integrity or usability.
Departure from administrative or process-oriented SOPs must be approved by the
local QM.
Documentation of the reason for the SOP departures must be retained with
management approval. Approved departures from test method SOPs should be noted
in the final test report to advise the data user.
See SOP ENV-SOP-CORQ-0016 SOP for SOPs and SWI, for more information.
4.9.1.2 Authorized Departure from Test Methods (Method Modifications)
When test results are associated to a published reference test method, the location’s
test method SOP must be consistent with the test method. If the test method is
mandated for use by a specific regulatory program such as drinking water, wastewater
or a certification or accreditation program, such as TNI/NELAC, the SOP must
comply with or include these requirements, or the resulting data and test results
cannot be used for regulatory compliance purposes.
If the procedures in the SOP are modified from the test method, these modifications
must be clearly identified in the SOP. The conditions under which the location may
establish an SOP that is modified from these reference method or regulatory program
and what is considered a modification are specified in ENV-SOP-CORQ-0011 Method
Validation and Instrument Verification.
Client requests to deviate from the test method are managed as client requests to
depart from the test method SOP since it is the SOP that the location follows when
performing work.
4.9.1.3 Stop Work Authority
Stop Work Authority provides PAS personnel with capability to stop work when there
is a perceived unsafe condition or behavior that may result in an unwanted event.
All personnel have the authority to request a stop work order when necessary to
preserve data integrity or safety of workers.
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The need for the stop work order and resolution of the problem must be confirmed
by subject matter experts and resumption of work must be approved as follows:
For stop work orders related to environmental health and safety (EHS) and/or
waste management, the decision to stop work may be made by any employee.
These decisions must often be made in real-time to protect the safety of the
worker. The decision to correct the problem, how, and/or to resume work after
stop work has been initiated may be made by the Chief Compliance Officer or
the EHS Director, or the deputies assigned to these positions.
Any employee may recommend a stop work order for concerns related to data
integrity. The need to stop work must be reviewed and affirmed by quality
personnel to confirm the concern is valid. The decision to uphold the stop work
order must minimally include the local QM, the QPM, and the Corporate Quality
Director. The President, the Sr. VPO, the VPO, the Chief Compliance Officer
and Chief Technical Officer may also be included in the decision making and
resolution process depending on the situation and/or needs for correction to
ensure protocols for investigation are followed. Resumption of work after
correction may be made by the Corporate Quality Director, or the Quality
Program Manager assigned to the location for which the stop work order was
issued or by the deputies assigned to these positions.
4.10 Continuous Improvement
The PAS QMS is designed to achieve continuous improvement through the implementation of the
quality policy and objectives outlined in this manual. Information about laboratory and service center
activities and performance is gained from sources such as customer feedback, audits, QC, trend
analysis, business analytics, management reports, proficiency testing, and management systems review.
This information is subsequently used during the corrective action (see section 4.11) and preventive
action (see section 4.12) processes and during annual review of the management system (see section
4.15) to establish goals and objectives for improvement.
PAS also promotes a continuous improvement culture based on the principles of lean manufacturing.
These principles include 3P (Process, Productivity, Performance) and Kaizen. 3P is a platform used
by Pace to share best practices and standardization across the network to achieve operational
excellence. Kaizen is a team-based process used to implement tools and philosophies of lean to reduce
waste and achieve flow with the purpose of improving both external and internal customer
satisfaction. All activities of 3P and Lean must conform with the requirements of this quality manual
and supporting policies and procedures.
4.11 Corrective Action
Corrective action is a process used to eliminate the cause of a detected nonconformity. It is different
from a correction. A correction is an action taken to fix an immediate problem but that does not
resolve the underlying cause of why the problem occurred. The objective of corrective action is to
find the underlying cause(s) of the problem and to put in place fixes to prevent the problem from
happening again. The corrective action process, referred to as CAPA, is one of the most effective
tools used by PAS to prevent nonconforming work, identify risk and opportunity, and improve service
to our customers.
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PAS has two general processes for corrective action, the application of which process is used depends
on the type of nonconformity:
Quality control (QC) exceptions (nonconformance) that occur during routine testing is investigated
through troubleshooting and required actions for correction is specified in policies and SOPs. When
action is not taken, cannot be taken, or is not successful, test results associated with the
nonconforming work are qualified in the final test report. Documentation of the nonconformance
and corrective action taken is documented in the analytical record.
A 7-stage corrective action process is used when there is a recurring problem. These problems are
identified through various activities such as but not limited to quality control trends, internal and
external audits, management review, customer feedback, and general observation.
The 7 Stage CAPA Process for PAS includes:
1) Identification and Containment
2) Evaluation
3) Investigation
4) Cause Analysis
5) Action Plan
6) Implementation
7) Follow Up and Effectiveness Review
PAS procedures for corrective action, are specified in corporate SOP ENV-SOP-CORQ-0018
Procedure for Corrective and Preventive Action. Some key concepts and activities related to the PAS
corrective action process is provided in the next three subsections.
4.11.1 Cause Analysis (AKA Root Cause Analysis)
Cause analysis is the process of investigation used to identify the underlying cause(s) of the
problem. After causal factors are identified, ways to mitigate the causal factors are identified
and action(s) most likely to eliminate these factors are taken.
PAS uses different methods to conduct cause analysis. The most common approach is 5-Why,
4M, Fishbone Diagrams, or brainstorming may be appropriate depending on the situation.
The method used is case specific and is documented in the CAPA record.
4.11.2 Effectiveness Review
Monitoring corrective actions taken for effectiveness is an essential part of the corrective
action process. Effectiveness means the actions taken were appropriate and sustainable.
Appropriate means the action(s) taken prevented recurrence of the problem since the time
corrective action was taken and sustainable means the actions taken are still in place.
The data from CAPA records are used by PAS to identify opportunities for preventive action
or to gain lessons learned when actions taken were not adequate to solve the problem. See
Section 4.12 (Preventive Action) and 4.15 (Management Review) for more information.
4.11.3 Additional Audits
When cause analysis and investigation of a problem casts doubt on compliance with PAS
policies, procedures, or to regulatory requirements; a special audit of the area of activity may
be performed as part of the corrective action process. These special audits are used to
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determine the scope of the problem and to provide information for the CAPA process.
Additional full-scale audits are done when a grave issue or risk to the business is identified.
4.12 Preventive Action
Preventive action(s) are actions taken to eliminate the cause of a potential nonconformity before it
happens.
Some examples of preventative action include, but are not limited to:
Routine instrument maintenance (Preventative maintenance)
Addition of Staff and Equipment
Professional Development Activities
Implementation of New Technology
PAS looks for opportunities for preventive action from a variety of sources including employee idea’s,
customer feedback, business partners input, trend analysis, business analytics, management reviews,
proficiency testing results, and risk-benefit analysis.
PAS management evaluates the success of preventive actions taken in any given year during annual
management review. See Section 4.15 for more information.
4.12.1 Change Management
Preventive actions may sometimes result in significant changes to processes and procedures
used by PAS locations. PAS management evaluates the risks and benefits of change and
includes in its implementation of change process, actions to minimize or eliminate any risk.
The types of changes for which risk are considered and managed include infrastructure change,
change in analytical service offerings, certification or accreditation status, instrumentation,
LIMS changes, and changes in key personnel.
4.13 Control of Records
A record is a piece of evidence about the past, especially an account of an act or occurrence kept in
writing or another permanent form. PAS records document activities and provide evidence of
conformity to the requirements established in the QMS. These records may be hardcopy or electronic
on any form of media.
4.13.1 General Requirements
4.13.1.1 Procedure
PAS requirements for control of records are specified in corporate policy ENV-POL-
CORQ-0013 Record Management.
The policy is established to assure quality and technical records are identified, retained,
indexed, and filed to allow for retrieval during the entire retention timeframe. During
storage, records are kept secure and protected from deterioration. At the end of the
retention time, the records are disposed of properly in order to maintain client
confidentiality and to protect the interests of the company.
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In general, records fall into three categories: quality, technical, and administrative.
Examples of each are provided in the following table:
Record Type Includes Records of:
Quality Document Types listed in SOP ENV-SOP-CORQ-0015
Audits: Internal and External
Certificates and Scopes of Accreditation
Corrective & Preventive Action
Management Review
Data Investigations
Method Validation
Instrument Verification
Training Records
Technical Raw Data
Logbooks
Certificates of Traceability
Analytical Record
Test Reports & Project Information
Technical Training Records & Demonstration of Capability
Administrative Personnel Records
Finance/Business
4.13.1.2 Record Legibility and Storage
Records are designed to be legible and to clearly identify the information recorded.
Manual entries are made in indelible ink; automated entries are in a typeface and of
sufficient resolution to be read. The records identify personnel that performed the
activity or entered the information. Records are archived and stored in a way that they
are retrievable. Access to archived records is controlled and managed.
For records stored electronically, the capability to restore or retrieve the electronic
record is maintained for the entire retention period. Hardcopy records are filed and
stored in a suitable environment to protect from damage, deterioration, or loss.
Hardcopy records may be scanned to PDF for retention. Scanned records must be
checked against the hardcopy to verify the scan is complete and legible.
Administrative records are kept for a minimum of 5 years and technical and quality
records are kept for 10 years unless otherwise specified by the client or regulatory
program.
The date from which retention time is calculated depends on the record. In general,
the retention time of technical records of original observation and measurement is
calculated from the date the record is created. If the technical record is kept in a
chronological logbook, the date of retention may be calculated from the date the
logbook is archived. The retention time of test reports and project records, which are
considered technical records, is calculated from the date the test report was issued.
The retention time of quality records is usually calculated from the date the record is
archived.
Refer to the record management policy and the location specific SOP for more
information.
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4.13.1.3 Security
PAS locations are secure facilities and access to records is restricted to authorized
personnel.
4.13.1.4 Electronic Records
The data systems used to store electronic records is backed up in accordance with
SOP ENV-SOP-MTJL-0058, Information Technology Processes and ENV-SOP-MTJL-
0010, Protection and Transfer of Laboratory Records.. Access to archived records stored
electronically is maintained by personnel responsible for management of the
electronic system.
4.13.1.5 Electronic Signature Policy
Work done by PAS locations include activities that require the application of a
signature. Some work product is in electronic format and signatures are applied
electronically.
The Electronic Signatures in Global and National Commerce Act (E-Sign Act)
clarifies that electronic signatures are legally valid and enforceable under United States
law.
The PAS policy for use and application of electronic signatures is specified in
corporate policy ENV-POL-CORQ-0014 Electronic Signature Policy.
All employees of PAS including temporary and contract personnel, must sign an
Electronic Signature Agreement to acknowledge that they understand and accept that
work activities performed by them may be authenticated with application of an
electronic signature and that electronic signature has the same validity as a
handwritten signature. Their signed agreement also confirms the individual has read
and understands the policy and agrees to abide by the requirements for use of
electronic signature stated in the policy.
4.13.2 Technical Records
In addition to the requirements specified in subsections 4.13.1.1 through 4.13.1.5, the
requirements in the following subsections also apply to technical records.
4.13.2.1 Description
Technical records are the accumulation of data and information generated from the
analytical process. These records may include forms, worksheets, workbooks,
checklists, notes, raw data, calibration records, final test reports, and project record.
The accumulated record needs to provide adequate detail to historically reconstruct
the process and identify the personnel that performed the tasks associated with a test
result.
4.13.2.2 Real Time Recordkeeping
Personnel are instructed and expected to always record observations, data, and
calculations at the time they are made. PAS managers are responsible to assure that
data entries, whether made electronically or on hardcopy, are identifiable to the task.
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4.13.2.3 Error Correction
Errors in records must never be erased, deleted, or made illegible. Use of correction
fluid, such as white-out is prohibited. In hardcopy records, the error is corrected by a
single strike through the original entry and the new entry recorded alongside or
footnoted to allow for readability. Corrections are initialed and dated by the person
making the correction. If the correction is not self-explanatory, a reason for the
correction is recorded.
For electronic records, equivalent measures of error correction or traceability of
changes made is kept. For example, audit trails provide records of change.
Maintenance of proper practices for error correction is monitored through the tiered
data review process described in Section 5.9.3. Records are reviewed throughout the
data review process. Individuals performing these reviews flag errors that are not
properly corrected and bring these to the attention of the department manager or
supervisor of the work area in which the record was generated so that the problem
may be addressed and corrected with the individual(s) that did not make the
correction properly.
4.14 Audits
Quality personnel, or their designees, perform internal systems and technical audits to assess
implementation of the QMS, compliance to this manual, policy, and procedures that make up the
QMS. Since the processes in this manual are based on the requirements from relevant and applicable
Standards for the operation and management of laboratories when operations are assessed against the
PAS QMS, compliance with regulatory program requirements and accreditation/certification program
requirements are also assessed.
PAS locations are also audited by external parties such as regulatory agencies, customers, consultants,
and non-government assessment bodies (NGAB).
Information from internal and external audits is used by local and corporate management to address
deficiencies and to identify opportunities to improve customer service and quality of work, including
reliability and usability of data and test results.
Deficiencies, observations, and recommendations from audits are managed by the local QM using the
CAPA process. See Section 4.11 for more information.
4.14.1 Internal Audit
The PAS internal audits are conducted to ensure practice matches what we say we do and what
we say we do is compliant with the PAS QMS and relevant standards and requirements.
The internal audit program is managed by the local QM who prepares an audit plan at the
beginning of each calendar year. The schedule is prepared to assure that all work areas are
reviewed over the course of the year and test methods are audited every two years, unless a
more frequent test method audit is required by program. Conformance to the schedule is
monitored on a monthly basis.
PAS management is responsible to ensure the audit schedule is maintained. PAS supervisors
are expected to cooperate with the quality personnel to provide them with complete access to
the work area, personnel, and records needed to conduct the audit.
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Internal audits may be performed by non-quality personnel when the auditor is approved by
the local QM. Non-quality personnel may not audit their own work activities unless it can be
demonstrated that an effective and objective audit will be conducted. The person conducting
the audit should be trained, qualified, and familiar enough with the objectives and policies of
the PAS QMS and knowledgeable with process and test method SOPs related to the activities
audited. The auditors should be trained in auditing practices in order to perform a thorough
and effective evaluation.
Test method audits include reviews of test reports to verify the product is consistent with
customer/project requirements, the work was conducted in accordance with policy and SOPs,
the SOP complies with the cited reference method, test results are accurate, and of known and
documented quality and properly qualified, when necessary.
Special audits are performed as needed to follow up on a specific issue such as a client
complaint, negative feedback, concerns of data integrity or ethics, or a problem identified
through other audits. Special audits may be scheduled or unscheduled. Unscheduled internal
audits are conducted whenever doubts are cast on compliance with regulatory requirements
or its own policies and procedures. These unscheduled internal audits may be conducted at
any time and may be performed without an announcement to the location or work area
audited.
When observations and findings from any audit (internal or external) cast doubt on the validity
of testing results, the location takes immediate action to investigate the problem and take
corrective action. (Also see 4.11 and 4.16)
4.14.1.1 Corporate Compliance Audit
PAS locations may also be audited by corporate personnel at discretion. The purpose
of the corporate compliance audit is to assess whether the location’s practices,
processes and procedures conform with the PAS QMS and to identify risk and
opportunity.
4.15 Management Review
Local management conducts an annual business review of each location under their purview to assess
performance and to establish goals, objectives, and action plans for the upcoming year.
The procedure used to conduct this review is specified in corporate SOP ENV-SOP-CORQ-0005
Management Review.
At a minimum, the following topics are reviewed and discussed during annual management review:
Changes in internal and external issues relevant to the location;
Fulfillment of objectives and initiatives;
suitability of policies and procedures, including EHS and waste management;
status of actions from previous performance reviews;
The outcome of recent internal audits;
Corrective and preventive actions;
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Assessments by external bodies;
The results of interlaboratory comparisons or proficiency tests;
Changes in the volume and type of the work;
Customer and personnel feedback, including complaints;
Effectiveness of improvements / preventive actions made since last review;
Adequacy of resources;
results of risk identification;
Proficiency testing performance and other measures related to the assurance of validity of test
results; other relevant factors, such as QC trends and training status.
The discussion and results of this review are documented in a report prepared by local management.
This report includes a determination of the effectiveness of the management system and its processes,
goals, and objectives for improvements in the coming year with timelines and responsibilities, and any
other need for change.
Goals and action items from annual management systems review are shared with local employees and
with corporate management to highlight focus areas for improvement in addition to areas in which
the location has excelled.
4.16 Data Integrity
PAS procedures for the investigation and response to events that may affect data integrity are
described in the corporate SOPs for data inquiries and data recall and corrective and preventive action,
however named.
Customers whose data are affected by these events are notified in a timely manner, usually within 30
days after the impact of the problem is understood. Some accreditation programs also require
notification to the accreditation body (AB) within a certain timeframe from date of discovery when
the underlying cause of the issue impacts accreditation. PAS locations must follow any program or
project specific client notification requirements for notification, when applicable.
5.0 TECHNICAL REQUIREMENTS
5.1 General
Multiple factors contribute to the correctness and reliability of the technical work performed by PAS.
These factors fall under these broad categories:
Human Performance
Facility and Environmental Conditions
Test Method Performance and Validation
Measurement Traceability
Handling of Samples
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The impact of each of these factors varies based on the type of work performed. To minimize negative
effects from each of these factors, PAS accounts for the contribution from each of these categories
when developing test method and process (administrative) SOPs, evaluating personnel qualifications
and competence, and in the selection of equipment and supplies used.
5.2 Personnel
5.2.1 Personnel Qualifications
The PAS program for personnel management is structured to ensure personnel are selected,
qualified, and competent to perform the roles and responsibilities of their position based on
education, experience, and training.
Qualifications, duties, responsibilities, and authorities of each position are specified in job
descriptions maintained by corporate HR (See Section 5.2.4). These job descriptions provide
the general basis for the selection of personnel for hire and are used by the location to
communicate to personnel the duties, responsibilities, and authorities of their position.
Qualification records may include but are not limited to diploma, transcripts, and curriculum
vitae (CV).
The term “personnel” refers to individuals employed by PAS directly as full-time, part-time,
or temporary, and individuals employed by PAS by contract, such as through an employment
agency. The term “personnel” is used interchangeably with the term “employee” throughout
this manual. For purposes of this manual, these terms are equivalent.
The personnel management program is structured to establish and maintain records for each
of the following:
Selection of personnel;
Training of personnel;
Supervision of personnel;
Authorization of personnel; and
Monitoring Competence of personnel.
5.2.1.1 Competence
Competence is the ability to apply a skill or series of skills to complete a task or series
of tasks correctly within defined expectations.
Competence for technical personnel authorized by PAS to provide opinion and
interpretation of data to customers also includes the demonstrated ability to:
Apply knowledge, experience, and skills needed to safely and properly use
equipment, instrumentation, and materials required to carry out testing and other
work activities in accordance with manufacturer specifications and location
SOPs;
Understand and apply knowledge of general regulatory requirements necessary to
achieve regulatory compliance in work product; and
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Understand the significance of departures and deviations from procedure that
may occur during the analytical testing process and the capability and initiative to
troubleshoot and correct the problem, document the situation and decision-
making process, and to properly qualify the data and analytical results.
PAS requirements for the competence of personnel (education, qualification, work
experience, technical skills, and responsibilities) are specified in job descriptions
created by management and kept by human resources (HR). The job description
provides the basis for the selection of personnel for each position.
An employee is considered competent when he/she has completed the required
training specified in Section 5.2.2 and documentation of training is complete.
5.2.2 Training (Required)
Pace® training requirements are outlined in Pace® policies COR-POL-0023 Mandatory
Training Policy and COR-POL-0004 Code of Ethics and Professional Conduct.
5.2.2.1 Required Training Requirements
The PAS training program includes these elements:
Scheduling
Execution
Documentation and Tracking
Evaluation of Effectiveness
Required training is scheduled by corporate training personnel, local quality
personnel, and the employee’s direct supervisor.
Training on required topics, processes and procedure is delivered using various
methods that incorporate techniques that appeal to the main learning styles: visual,
aural, linguistic, and kinesthetic. Techniques include, on-the-job, instructor-led, self-
study, eLearning, and blended.
The employee’s direct supervisor is responsible for oversight of completion of the
employee’s required training and for providing adequate time to the employee to
complete training assignments. The supervisor and employee are responsible to make
sure the employee’s training status and training records for all required training is
current, complete, and documentation of training is available.
Training status is tracked by the local QM, who provides the status to local
management at least monthly or more frequently, as necessary, to ensure required
training for personnel is complete and up to date.
The following subsections further describe the required PAS training program for
new hire training and on-going training.
5.2.2.1.1 New Hire Required Training
New hire training requirements apply to new personnel and to
existing employees starting in a new position or different work area.
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Required new hire training includes training on each of the
following:
Ethics and Data Integrity (See 5.2.2.1.3)
Quality Manual / Quality Management System (See 5.2.2.1.4)
Safety Manual and any training requirements specified in the
manual.
Policies & SOPs relevant to their job tasks
Technical personnel that prepare and test samples must also
successfully complete an initial demonstration of capability
(IDOC) for the test methods performed before independently
testing customer samples. (See 5.2.2.1.5). Independent testing
means without direct supervision of the work activity by the
supervisor or a qualified trainer.
All required training must be documented and verified complete by
the local QM before the employee is authorized to work
independently on client samples. Until then, the employee’s direct
supervisor is responsible for all work produced by the new employee
under their supervision.
5.2.2.1.2 On-Going Required Training
Personnel receive on-going training in each of the following topics:
Ethics and Data Integrity (See 5.2.2.1.3)
Quality Manual / Quality Management System (See 5.2.2.1.4)
Safety
Changes to Policies & SOPs, relevant to their job activities.
New Policies & SOPS, relevant to their job activities.
Technical personnel must also successfully complete on-going
demonstration of capability (CDOC) for all test methods
performed on an annual basis. (See 5.2.2.1.5)
All required training must be documented and verified complete by
the local QM with training records readily accessible in accordance
with the corporate policy for Record Management (ENV-POL-
CORQ-0013).
5.2.2.1.3 Ethics and Data Integrity Training
Data integrity training is provided to all new personnel and refresher
data integrity training is provided to all employees on an annual basis.
Personnel are required to acknowledge they understand that any
infractions of the PAS data integrity procedures will result in a
detailed investigation that could lead to profound consequences
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including immediate termination, debarment, or civil/criminal
prosecution.
Completion of data integrity training is documented using the
mechanism established by Pace® to provide evidence that the
employee has participated in training on this topic and understand
their obligations related to data integrity.
The following topics and activities are covered:
Policy for honesty and full disclosure in all analytical reporting;
Prohibited Practices;
How and when to report data integrity issues;
Record keeping. The training emphasizes the importance of
proper written documentation on the part of the analyst with
respect to those cases where analytical data may be useful, but
are in one sense or another partially nonconforming;
Training Program, including discussion regarding all data
integrity procedures;
Data integrity training documentation;
In-depth procedures for data monitoring; and
Specific examples of breaches of ethical behavior such as
improper data manipulations, adjustments of instrument time
clocks, and inappropriate changes in concentrations of
standards.
All PAS personnel, including contract and temporary, are required
to sign an “Attestation of Ethics and Confidentiality” at the time of
hire and/or during annual refresher training or as specified in the
ethics policy. This document clearly identifies inappropriate and
questionable behavior. Violations of this document result in
profound consequences, including prosecution and termination, if
necessary.
Also see SOP-ENV-COR-POL-0004 Code of Ethics and Professional
Conduct for more information.
5.2.2.1.4 Management System Documents Training
The Quality Manual policies, and SOPs are the documents used by
regulatory bodies and Pace® customers to verify capability,
competency, and compliance with their requirements and
expectations.
In addition to on-the-job training, employees must have a signed
Read and Acknowledgement Statement (R&A) on record for the
quality manual, and the policies and SOPs relating to his/her job
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responsibilities. This statement, whether signed by the employee
electronically or by wet signature, confirms that the employee has
received, read, and understands the content of the document, that
the employee agrees to follow the document when carrying out their
work tasks; and the employee understands that unauthorized change
to procedures in an SOP is not allowed except in accordance with
the SOP departure policy (See 4. 9.1).
See SOP ENV-CORQ-0016 Standard Operating Procedures and Standard
Work Instructions for more information.
5.2.2.1.5 Demonstration of Capability (DOC) Requirements
An initial demonstration of capability (IDOC) must be completed
and validated prior to authorization for the employee to work
independently on client samples for the test method. After
successful IDOC, the employee must demonstrate continued
proficiency (CDOC) for the test method on an annual basis. If more
than a year has passed since the employee last performed the
method; then capability must be re-established with an IDOC.
Successful DOC is one where the DOC replicate data has been
compiled, reviewed, and verified by the employee’s supervisor
and/or manager to be complete and to have met acceptance criteria
and the DOC record has been validated by quality personnel for
completeness and compliance, and placed in the employee’s training
file for accessibility and reference.
Demonstration of capability (DOC) procedures and requirements
vary by technology.
For example, a DOC for chemistry test methods where spiking is
appropriate, is based on the employee’s capability to achieve
acceptable precision and accuracy for each analyte reported by the
laboratory for the test method using the laboratory’s test method
SOP.
DOC procedures and requirements must be specified in the
laboratory’s test method SOP or a stand-alone SOP. Refer to these
SOPs for more information.
5.2.2.1.6 Effectiveness of Training
Effectiveness of individual employee training is measured by their
demonstrated ability to comprehend the training material and apply
knowledge and skills gained to their job task. Measurements include
but are not limited to:
Testing of the employee’s knowledge of the QMS, policies, and
technical and administrative procedures through various
mechanisms, such as quizzes, observation, and interviews.
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Demonstrated ability to convey information correctly and
factually in written and verbal communication to internal and
external parties.
Demonstrated ability to carry out tasks in accordance with SOPs
and other work instructions.
Demonstrated ability to make sound decisions based on
guidance and information available.
Demonstrated initiative to seek help or guidance when the
employee is unsure of how to proceed.
5.2.2.2 Supplemental Learning
Supplemental learning objectives may be established for newly hired personnel to aid
in their development of administrative and technical skills. These learning objectives
and materials, referred to as Learning Plans (LP), are created and maintained by the
PAS 3P program and managed by the employee’s direct supervisor.
Pace® also offers a wide variety of supplemental learning courses that are made
available to all employees for professional development. These learning materials,
maintained by Pace® corporate training personnel, are accessed via the company’s
employee portal, PaceConnect. The learning may be self-initiated based on an
employee’s interest or may be assigned to the employee at the discretion of
management as professional development as part of an employee’s annual goals.
Supplemental learning courses and learning plan activities are not prerequisites for
competency (Section 5.2.1.1) and are not considered part of the required PAS QMS
training program.
5.2.3 Personnel Supervision
Every employee is assigned a direct supervisor, however named, who is responsible for their
supervision.
General supervisory responsibilities may include but are not limited to:
Hiring Employees
Training Employees
Performance Management
Development, oversight, and execution of personnel training plans
Monitoring personnel work product to assure the work is conducted in accordance with
this quality manual, policies, SOPs, and other documents that support the QMS.
5.2.4 Job Descriptions
Job Descriptions that define the required education, qualifications, experience, skills, roles and
responsibilities, and reporting relationships for each Pace® position are established by top
management and kept by corporate HR. The job descriptions apply to employees who are
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directly employed by Pace®, part-time, temporary, technical, and administrative and by those
that are under contract with Pace® through other means.
The job descriptions include the education, expertise, and experience required for the position
and the responsibilities and duties, including any supervisory or managerial duties assigned to
the position.
5.2.5 Authorization of Technical Personnel
Technical personnel are authorized by local quality personnel to perform the technical aspects
of their position after quality personnel have verified that the employee meets the
qualifications for the position, has successfully completed required training (Section 5.2.2.1),
and the employee has completed initial demonstrated capability (Section 5.2.2.1.5). After initial
authorization, technical personnel are expected to maintain a current and complete training
record, demonstrate on-going capability at least annually for each test method performed, and
produce reliable results through accurate analysis of certified reference materials, proficiency
testing samples, and/or routine quality control samples in order to remain authorized to
continue to perform their duties.
Records to support authorization including, education, experience, training, and other
evaluations are kept by the location where the employee works.
5.3 Accommodations and Facilities
5.3.1 Facilities
PAS laboratories and service centers are designed to support the correct performance of
procedures and to not adversely affect measurement integrity or safety. Access to PAS facilities
is controlled by various measures, such as card access, locked doors, staffed main entry.
5.3.2 Environmental Conditions
Each location is equipped with energy sources, lighting, heating, and ventilation necessary to
facilitate proper performance of calibrations and tests. The location ensures that
housekeeping, electromagnetic interference, humidity, line voltage, temperature, sound, and
vibration levels are appropriately controlled to ensure the integrity of specific measurement
results and to prevent adverse effects on accuracy or increases in the uncertainty of each
measurement.
Environmental conditions are monitored, controlled, and recorded as required by the relevant
specifications, methods, and procedures. Operations are stopped if it is discovered that the
environmental conditions would jeopardize the integrity of analytical results or other work
product.
5.3.3 Separation of Incompatible Activities
The layout and infrastructure of each work area including air handling systems, power supplies,
and gas supplies of each work area is specifically designed for the type of analytical activity
performed. Effective separation between incompatible work activities is maintained. For
example, sample storage, preparation, and chemical handling for volatile organic analysis
(VOA) is kept separate from semi-volatile organic (SVOA).
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Samples known or suspected to contain high concentration of analytes are separated from
other samples to avoid the possibility for cross-contamination. If contamination is found, the
source of contamination is investigated and resolved in accordance with applicable SOPs.
5.3.4 Security
Security is maintained by controlled access to the building and by surveillance of work areas
by authorized personnel. Access is controlled to each area depending on the required
personnel, the sensitivity of the operations performed, and potential safety concerns.
5.3.5 Good Housekeeping
PAS locations must maintain good housekeeping practices in work areas to maintain a
standard of cleanliness necessary for analytical integrity and personnel health and safety.
5.4 Test Methods
5.4.1 General Requirements
The laboratory uses test methods and procedures that are appropriate for the scope of
analytical services the laboratory offers.
Instructions on the use and operation of equipment and sample handling, preparation, and
analysis of samples are provided in SOPs. The instructions in SOPs may be supplemented
with other documents including, but not limited to, standard work instructions (SWI),
manuals, guides, project documents and reference documents.
These documents are managed using the procedures described in SOP ENV-SOP-CORQ-
0015 Document Management and Control and SOP ENV-SOP-CORQ-0016 Standard Operating
Procedures and Standard Work Instructions.
5.4.2 Method Selection
The test methods and protocols used by the laboratory are selected to meet the needs of the
customer, are appropriate for the items tested, for the intended use of the data, and to conform
with applicable federal, statutory, or program requirements.
The test methods offered by PAS are industry accepted methods published by international,
regional, or national standards. Each PAS laboratory bases its procedure on the latest approved
edition of a method unless it is not appropriate or possible to do so, or unless regulatory
requirements specify otherwise.
The laboratory confirms that it can perform the test method and achieve desired outcome
before analyzing samples (see section 5.4.5). If there is a change in the published analytical
method, then the confirmation is repeated.
When a customer does not specify the test method(s) to be used, the laboratory may suggest
test methods that are appropriate for the intended use of the data and the type of samples to
be tested. The laboratory will also inform customers when test methods requested are
considered inappropriate for their purpose and/or out of date. This discourse takes place
during review of analytical service requests (See Section 4.4).
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5.4.3 PAS Developed Methods
A PAS developed method is a method developed from scratch (no published source method),
a procedure that modifies the chemistry from the source method, or a procedure that exceeds
the scope and application of the source method.
PAS developed methods must be validated prior to use (see section 5.4.5) and the procedure
documented in a test method SOP.
The requirements for non-standard methods (Section 5.4.4) also apply to PAS developed
methods.
5.4.4 Non-standard Methods
A non-standard method is a method that is not published or approved for use by conventional
industry standards for the intended purpose of the data. Non-standard methods must be
validated prior to use (see section 5.4.5) and the procedure developed and documented in a
test method SOP.
At a minimum, the following information must be included in the procedure:
Title / Identification of Method;
Scope and Application;
Description of the type of item to be analyzed;
Parameters or quantities and ranges to be determined;
Apparatus and equipment, including technical performance requirements;
Reference standards and reference materials required;
Environmental conditions required and any stabilization period needed; and
Description of the procedure, including:
o Affixing identification marks, handling, transporting, storing, and preparing of
items;
o Checks to be made before the work is started;
o Verifying equipment function and, where required, calibrating and/or adjusting
the equipment before each use;
o Method of recording the observations and results;
o Any safety measures to be observed;
o Criteria and/or requirements for approval/rejection;
o Data to be recorded and method of analysis and presentation; and
o Uncertainty or procedure for estimating uncertainty.
Use of a non-standard method for testing must be agreed upon with the customer. The
agreement, which is retained by the laboratory in the project record, must include the
specifications of the client’s requirements, the purpose of testing, and their authorization for
use of the non-standard method.
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5.4.5 Method Validation
5.4.5.1 Validation Description
Validation is the process of confirmation and the provision of objective evidence that
the stated requirements for a specific method/procedure are fulfilled.
The laboratory’s requirements and procedures for method validation are outlined in
SOP ENV-SOP-CORQ-0011 Method Validation and Instrument Verification.
5.4.5.2 Validation Summary
All test methods offered by the laboratory are validated before use to confirm the
procedure works and the data and results achieved meet the goals for the method and
repeated when there are major changes to the laboratory procedure.
Results of validation are retained are kept in accordance with method validation SOP
and the corporate policy ENV-CORQ-POL-0013 Record Management.
5.4.5.3 Validation of Customer Need
The validation process includes review of accuracy, precision, sensitivity, selectivity,
linearity, repeatability, reproducibility, robustness, and cross-sensitivity of the
procedure against general customer needs to ensure the laboratory’s procedure will
meet those needs.
The following subsections explain some concepts as they are applied to chemistry.
The applications of these same concepts may differ for other technologies such as
microbiology, radiochemistry, whole effluent toxicity (WET), and asbestos or other
validation concepts may apply to these disciplines. Refer to the laboratory’s test
method SOPs for more information.
5.4.5.3.1 Accuracy
Accuracy is the degree to which the result of a measurement,
calculation, or specification conforms to the correct value or a
standard. When the result recovers within a range from the known
value (control limit); the result generated using the laboratory’s test
method SOP is considered accurate.
5.4.5.3.2 Precision
Precision refers to the closeness of two or more measurements to
each other. It is measured by calculating the relative percent
difference (RPD) or relative standard deviation (RSD) from results
of separate analysis of the same sample. Precision provides
information about repeatability, reproducibility, and robustness of
the laboratory’s procedure.
5.4.5.3.3 Limits of Detection (LOD) (Chemistry)
The LOD is the minimum result which can be reliably discriminated
from a blank with a predetermined confidence level. The LOD
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establishes the limit of method sensitivity and is also known as the
detection limit (DL) or the method detection limit (MDL).
Values below the LOD cannot be reliably measured and are not
reported by the laboratory unless otherwise specified by regulatory
program or test method.
The LOD is established during method validation and after major
changes to the analytical system or procedure that affect sensitivity
are made.
The laboratory’s procedure for LOD determination is specified in
SOP ENV-SOP-MTJL-0016, Method Detection Limits (MDL), Limits
of Detection (LOD) and Limits of Quantitation (LOQ) and ENV-SOP-
MTJL-0340, Radiochemistry Method Performance Criteria.
For chemistry methodology, the local SOP must comply with the
current version of each of the following documents:
EPA document EPA-821-R-16-006 Definition and Procedure for the
Determination of the Method Detection Limit;
2016 TNI Standard V1M4; and
TNI GUID-3-109-Rev. 0, V1M4 2016 Standard Update Guidance
on Detection and Quantitation.
5.4.5.3.4 Limits of Quantitation (LOQ) and Reporting Limit (RL)
This section describes these concepts for chemistry. For non-
chemistry technologies, such as microbiology, refer to laboratory
SOPs.
The LOQ is the minimum level, concentration, or quantity of a
target analyte that can be reported with a specified degree of
confidence.
The LLOQ is the value of the lowest calibration standard included
in the calibration curve. The LLOQ establishes the lower limit of
quantitation; it is not the same concept as the LOQ, however, the
LOQ and LLOQ may be the same value.
The LOQ and LLOQ represent quantitative sensitivity of the test
method.
The LOQ must always be equal to or greater than the LLOQ
and the LLOQ must always be greater than the LOD.
Any reported value (detect or non-detect) less than the LLOQ
is a qualitative value.
The RL is the value to which the presence of a target analyte is
reported as detected or not detected. The RL is project-defined
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based on project data quality objectives (DQO). In the absence of
project specific requirements, the RL is usually set to the LOQ or
the LLOQ.
The laboratory’s procedures for LOQ determination must be
specified in the same SOP for LOD determination, (See Section
5.4.5.3.3) The LLOQ for each method must be specified in the test
method SOP.
Linearity is a mathematical concept applied to calibration models
that employ multiple points to establish a calibration range used for
quantitative analysis. Linearity is measured differently based on the
calibration model. In general, if linearity is demonstrated then the
slope of the response of standards are sufficiently close to one
another. The accuracy of the linear regression and non-linear curves
is verified by checking percent error or relative standard error (RSE),
which is the process of refitting calibration data back to the model
to determine if the results are accurate. For linear curves that use
average calibration or response factor, error is measured by relative
standard difference (RSD).
Linearity also establishes the range of quantitation for the test
method used which directly impacts the sensitivity of the test
method and uncertainty in measurement results. As previously
noted, the LLOQ establishes the lower limit of quantitation.
Similarly, the upper range of linearity establishes the upper limit of
quantitation. In general, results outside of this range are considered
qualitative values. However, inorganic test methods sometimes allow
for extension of the linear range above the upper limit of
quantitation when accuracy at this value is verified.
Linearity can also be used to establish repeatability, reproducibility,
and robustness of the laboratory’s test method. When linearity is
demonstrated using a specific calibration model during method
validation, then use of this same calibration model to achieve
linearity on a day-to-day basis confirms the laboratory’s method is
repeatable, reproducible, and robust.
5.4.5.3.5 Demonstration of Capability (DOC)
The DOC performed during method validation confirms that the
procedure demonstrated acceptable precision and accuracy.
5.4.6 Measurement Uncertainty
The location provides an estimate of uncertainty in testing measurements with analytical
results on request, or when required. For example, for radiochemistry uncertainty is always
reported with the test result
For chemistry methodologies, the uncertainty of the test method is reflected in the control
limits used to evaluate QC performance for the test method. (See 5.9.1.1.9). ISO/IEC states
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that when a well-recognized test method specifies limits to the values of the major source of
uncertainty of measurement and specifies the form of presentation of calculated results, the
laboratory has satisfied the requirements on analytical uncertainty by following the test method
and reporting instructions.
When measurement uncertainty cannot be satisfied through control limits, the location will
provide a reasonable estimation of uncertainty. A reasonable estimation is based on knowledge
of method performance and previous experience. When estimating the analytical uncertainty,
all uncertainty components which are of importance in the given situation are considered.
5.4.7 Control of Data
PAS has policies and processes in place to assure that reported data is free from calculation
and transcription errors, that quality control is reviewed and evaluated before data is reported,
and to address manual calculation and integration.
5.4.7.1 Calculations, Data Transfer, Reduction and Review
Whenever possible, calculations, transfer of data, and data reduction are performed
using validated software programs (See 5.4.7.2).
If manual calculations are performed, the results of these calculations are verified
during the data review process outlined in section 5.9.3.
5.4.7.1.1 Manual Integration
The PAS policy and procedures for manual integration are provided
in corporate SOP ENV-SOP-CORQ-0006 Manual Integration.
This SOP includes the conditions under which manual integration is
allowed and the requirements for documentation.
Required documentation of manual integration includes:
complete audit trail to permit reconstruction of before and after
results;
identification of the analyst that performed the integration and
the reason the integration was performed; and
identification of the individual(s) that reviewed the integration
and verified the integration was done and documented in
compliance with the SOP.
5.4.7.2 Use of Computers and Automated Acquisition
Whenever possible, PAS uses software and automation for the acquisition,
processing, recording, reporting, storage, and/or retrieval of data.
Software applications developed by PAS are validated by corporate IT for adequacy
before release for routine use. Commercial off the shelf software is considered
sufficiently validated when the location follows the manufacturer or vendor’s manual
for set-up and use. Records of validation are kept by the corporate information
technology (IT) group or by the group that performed the validation.
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The PAS process for the protection of data stored in electronic systems includes:
Individual usernames and passwords for Laboratory Information Management
Systems (LIMS) and auxiliary systems used to store or process data.
Employee Training in Computer Security Awareness
Validation of spreadsheets used for calculations to verify formulas and logic yield
correct results and protection of these cells to prevent unauthorized change.
Operating system and file access safeguards
Protection from Computer Viruses
Regular system backup; and testing of retrieved data
Verification the software application works as expected and is adequate for use
and fulfills compliance requirements, such as the need to record date/time of data
generation.
Change control to assure requests for changes are reviewed and approved by
management before the change is made.
Communication channels to assure all staff are aware of changes made.
Version Control and maintenance of historical records.
5.5 Equipment
5.5.1 Availability of Equipment
Each PAS location is furnished with all equipment and instrumentation necessary to correctly
perform the tests offered in compliance with the specifications of the test method and to
achieve the accuracy and sensitivity required.
When a regulation, program, or reference test method requires Class A glassware for
quantitative measurements, only Class A glassware may be used. Plastic graduated cylinders,
even if marketed by the vendor as comparable to Class A glassware, may not be used when
Class A glassware is specified because ASTM’s definition and tolerances for Class A glass
cannot be applied to other materials.
5.5.2 Calibration
Equipment and instrumentation are checked prior to use to verify it performs within tolerance
for its intended application.
5.5.2.1 Support Equipment
The location confirms support equipment is in proper working order, uniquely
identified, and meets the specifications for use prior to placement in service. Periodic
checks are performed to verify tolerance and accuracy are performed thereafter in
accordance with a support equipment maintenance scheduled maintained by local
quality personnel. Equipment that does not meet specifications is removed from
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service until repaired or replaced. Records of repair and maintenance activities are
maintained.
Procedures used to conduct and record these checks are outlined in SOP ENV-SOP-
MTJL-0374, Support Equipment, ENV-SOP-MTJL-0047 Lockout/Tagout as well as
ENV-SOP-MTJL-0056 Instrument Transport.
5.5.2.2 Analytical Instruments
Analytical instruments are checked prior to placement in service in accordance with
SOP ENV-SOP-CORQ-0011 Method Validation and Instrument Verification. After the
initial service date, the calibration of instruments and verification calibration is
performed in accordance with local test method SOPs.
The calibration procedures in the test method SOPs comply with the requirements
for acceptable calibration practices outlined in corporate policy ENV-POL-CORQ-
0005 Acceptable Calibration Practices, the reference methods, and any applicable
regulatory or program requirements.
5.5.3 Equipment Use and Operation
Equipment is operated and maintained by personnel that are trained on the test method SOP.
Up-to-date instructions and procedures for the use and maintenance of analytical equipment
are included in SOPs and/or supplemental documents such as standard work instructions
(SWI) or instrument manuals which are made readily accessible in the work area to all
laboratory personnel.
5.5.4 Equipment Identification
Each piece of equipment must be uniquely identified by serial number or any other unique ID
system. The identifier is included in the equipment list maintained by the quality department
and may not be reused or used interchangeably. New equipment and replacement equipment
must be assigned a new unique ID.
5.5.5 Equipment Lists and Records
5.5.5.1 Equipment List
Each PAS location maintains a list of equipment that includes information about the
equipment including a description, manufacturer, serial number, date placed in
service, condition when received, identity, and the work area where the equipment is
used. The date of purchase is tracked by the procurement record. The equipment
list(s) for each location covered by this manual is provided in Appendix E.
5.5.5.2 Equipment Records
In addition to the equipment list, the location maintains records of equipment that
include:
Verification that equipment conforms with specifications.
Calibration records including dates, results, acceptance criteria, and next
calibration dates.
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Maintenance plan and records
Records of damage, malfunction, or repair
The laboratory follows an equipment maintenance program designed to optimize
performance and to prevent instrument failure which is described in SOP ENV-SOP-
MTJL-0373 Instrument Maintenance, ENV-SOP-MTJL-0374 Support Equipment, Env-
SOP-MTJL-0047 Lockout/Tagout as well as ENV-SOP-MTJL-0056 Instrument
Transport and/or in individual test method SOPs.
The maintenance program includes routine maintenance activities which are
performed as recommended by the manufacturer at the frequency recommended and
non-routine maintenance, which is performed to resolve a specific problem such as
degradation of peak resolution, shift in calibration relationship, loss of sensitivity, or
repeat failure of instrument performance checks and quality control samples.
Maintenance is performed by PAS personnel or by outside service providers.
All maintenance activities performed by PAS personnel are recorded by the
individual(s) that performed the activity at the time the maintenance was performed
in an instrument maintenance log.
The maintenance record minimally includes the date of maintenance, the initials of
the person(s) performing maintenance, a description of the activity performed, why
(when the maintenance is non-routine), and the return to analytical control. When
maintenance is performed by an external vendor, the service must be maintained and
accessible for easy retrieval. The location must provide personnel with unrestricted
access to instrument maintenance logs in order to promote good instrument
maintenance and recordkeeping practices.
If an instrument must be moved, the location will use safe practices for handling and
transport to minimize damage and contamination.
5.5.6 Out of Service Protocol
Equipment that has been subjected to overloading, mishandling, gives suspect results, has
been shown to be defective, or is performing outside of specified limits is taken out of service
and either removed from the work area or labeled to prevent accidental use until it has been
repaired and verified to perform correctly.
When analytical equipment is taken out of service because it no longer meets tolerance
specifications, the potential effect of the nonconformance may have had on previously
reported analytical results should be evaluated. (See section 4.9).
5.5.7 Calibration Status
The location labels support equipment to indicate calibration status, whenever practicable or
otherwise maintains the calibration status in a visible location in the work area. These
procedures are described in SOP ENV-SOP-MTJL-0373 Instrument Maintenance, ENV-
SOP-MTJL-0374 Support Equipment, Env-SOP-MTJL-0047 Lockout/Tagout as well as ENV-
SOP-MTJL-0056 Instrument Transport.
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The calibration status of analytical instruments is documented in the analytical record. Analysts
verify on-going acceptability of calibration status prior to use and with instrument
performance check standards. These procedures are described in test method SOPs.
5.5.8 Returned Equipment Checks
When equipment or an instrument is sent out for service, the location using the equipment
ensures that the function and calibration status of the equipment is checked and shown to be
satisfactory before the equipment is returned to service.
5.5.9 Intermediate Equipment Checks
The location performs intermediate checks on equipment to verify the on-going calibration
status. For example, most test methods require some form of continuing calibration
verification check, and these procedures are included in the test method SOP. Periodic checks
of support equipment are also performed; see ENV-SOP-MTJL-0373 Instrument Maintenance,
ENV-SOP-MTJL-0374 Support Equipment, Env-SOP-MTJL-0047 Lockout/Tagout as well as
ENV-SOP-MTJL-0056 Instrument Transport for more information.
5.5.10 Safeguarding Equipment Integrity
The location safeguards equipment integrity using a variety of mechanisms that include but
are not limited to:
Adherence to manufacturer’s specification for instrument use so that settings do not
exceed manufacturer’s recommendation or stress the performance of the equipment.
Established maintenance programs.
Transparent maintenance records and unrestricted access to maintenance logs.
Validation and approval of software before use.
Audits to confirm instrument settings are consistent with SOPs.
On-the-job training for safe and proper use of laboratory equipment.
5.6 Measurement Traceability
5.6.1 General
Measurement traceability refers to a property of a measurement result whereby the result can
be related to a reference through an unbroken chain of calibration, each contributing to the
measurement uncertainty. Traceability requires an established calibration hierarchy of
equipment (instruments) used during testing including equipment used for subsidiary
measurements. The location assures this equipment is calibrated prior to being put into service
and that the reference standard and materials used for calibration are traceable to the
international standard of units (SI) or national measurement standard.
When strict traceability to SI units cannot be made, the location establishes traceability with
the use of reference standards and equipment obtained from competent suppliers that provide
calibration certificates and/or certificates of analysis (COA).
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5.6.2 Equipment Correction Factors
When correction factors are used to adjust results the PAS personnel will assure that results
in computer software are also updated.
5.6.3 Specific Requirements
5.6.3.1 Requirements for Calibration Laboratories
The laboratory does not offer calibration services to customers; therefore, ISO/IEC
and TNI requirements for calibration laboratories do not apply.
5.6.3.2 Requirements for Testing Laboratories
The laboratory has procedures in place to verify equipment is calibrated prior to being
put into service (See 5.5.2) and ensures the reference standard and materials used for
calibration are traceable to the international standard of units (SI) or national
measurement standard. When strict traceability to SI units cannot be made, the
laboratory establishes traceability with the use of reference standards and equipment
obtained from competent suppliers that provide calibration certificates and/or
certificates of analysis (COA).
5.6.4 Reference Standards and Reference Materials
5.6.4.1 Reference Standards
The laboratory uses reference standards of measurement to verify adequacy of
working weights and thermometers. The working weights are the weight(s) used for
daily balance calibration checks and the working thermometers are used for daily
temperature measurements.
Working weights and thermometers must be periodically checked to verify on-going
adequacy for use between calibrations performed by an external calibration laboratory
using reference standards traceable to SI or a national standard and that are used solely
for verification purposes.
For example:
An acceptable reference standard to check working thermometers against include
a NIST Certified Thermometer or a NIST Traceable Thermometer that is not
used for any other purpose than to check the adequacy of the working
thermometer.
An acceptable reference standard for the working weights is a set of Class S
weights that is not used for any other purpose than to verify the weights used
daily.
The working weights must be checked against the reference standard annually and all
weight sets must be recertified by an ISO accredited calibration body every 5 years.
In this application, “annually” means within thirteen (13) months from the date of
the last check.
Working thermometers must be checked against the reference thermometer prior to
placement in service to establish a correction factor (CF)1 and then re-checked
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annually (±13 months from date of last check) or if battery operated, every three (3)
months (±100 days from date of last check).
Exceptions to the 3-month recheck for battery operated sensors are allowed when
the sensor is embedded in a unit and the manufacturer/vendor has evidence to show
that the accuracy of the sensor is not affected by battery life.
Liquid in Glass NIST Certified reference thermometers must be recertified by an
ISO/IEC accredited calibration laboratory every 5 years. If the reference
thermometer is NIST Traceable or is a digital NIST Certified thermometer, the
reference thermometer must be recertified annually by an ISO/IEC 17025 accredited
calibration laboratory or service provider that provides traceability to a national
standard.
If criteria for the intermediate checks or recertification is not acceptable, the impact
on previously reported results is evaluated using the process for evaluation of
nonconforming work (See 4.9).
See SOP ENV-SOP-MTJL-0373 Instrument Maintenance, ENV-SOP-MTJL-0374,
Support Equipment, Env-SOP-MTJL-0047 Lockout/Tagout as well as ENV-SOP-MTJL-
0056 Instrument Transport for more information.
5.6.4.2 Reference Materials
The location purchases chemical reference materials (also known as stock standards)
from vendors that are accredited to ISO 17034 or Guide 34. Purchased reference
materials must be received with a Certificate of Analysis (COA) where available. If a
reference material cannot be purchased with a COA, it must be verified by analysis
and comparison to a certified reference material and/or there must be a
demonstration of capability for characterization. COA are reviewed for adequacy and
retained by the laboratory for future reference.
All prepared standards, reference materials, and reagents are verified to meet the
requirements of the test method through routine analyses of quality control samples.
The laboratory procedure for traceability and use of these materials is provided in
SOP ENV-SOP-MTJL-0041 Standards Logger-Tree Operation, ENV-SOP-MTJL-0023
Storage of Consumables, and ENV-SOP-MTJL-0042 Standards Recertification.
This SOP includes each of the following requirements:
Procedures for documentation of receipt and tracking. The record of entry
includes name of the material, the lot number, receipt date, and expiration date.
Storage conditions and requirements. Reference materials must be stored
separately from samples, extracts, and digestates.
Requirements to assure that preparations of intermediate or working solutions
are recorded and assigned a unique identification number for tracking. Records
of preparation include the lot number of the stock standard(s) used, the type and
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lot number of the solvent, the formulation, date, expiration date, and the
preparer’s initials. The lot number of the working standards is recorded in the
analytical record to provide traceability to the standard preparation record. The
preparation record provides traceability to the COA, which is traceable to SI or
the national measurement standard.
A requirement that the expiration dates of prepared standards may not exceed
the expiration date of the parent standard. Standards, reference materials, and
reagents are not used after their expiration dates unless it is not possible to
procure a new standard and the reliability of the expired material is verified and
documented by the location using a procedure approved by corporate quality
personnel. Otherwise, the expired material is promptly removed from the work
area or clearly labeled as acceptable for qualitative/troubleshooting purposes
only.
The second source materials used for verification of instrument calibration are
obtained from a different manufacturer or may be a different lot from the same
manufacturer.
Procedures to check reference materials for degradation and replacement of
material if degradation or evaporation is suspected.
Procedures for labeling. At a minimum, the container must identify the material,
the ID of the material and the expiration date. Original containers should also be
labeled with date opened.
5.6.4.3 Intermediate Checks
Checks to confirm the calibration status of reference standards and materials must be
included in test method SOPs. These checks include use of second source standards
and reference materials reserved only for the purpose of calibration checks.
5.6.4.4 Transport and Storage
The location handles and transports reference standards and materials in a manner
that protects the integrity of the materials. Reference standard and material integrity
is protected by separation from incompatible materials and/or minimizing exposure
to degrading environments or materials. Standards and reference materials are stored
separately from samples, extracts, and digestates. All standards are stored according
to the manufacturer’s recommended conditions. Temperatures colder than the
manufacturer’s recommendation are acceptable if it does not compromise the
integrity of the material (e.g., remains in liquid state and does not freeze solid). In the
event a standard is made from more than a single source with different storage
conditions, the standard will be stored according to the conditions specified in the
analytical method.
See the applicable analytical SOPs for specific reference material storage and transport
protocols.
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5.7 Sampling
Sampling refers to the field collection of samples and to subsamples taken by the laboratory for
analysis from the field collected sample.
Subsampling procedures are included in each test method SOP or a stand-alone SOP to assure the
aliquot used for testing is representative of the field collected sample.
The requirements in the following subsections apply when field sampling is performed by PAS.
5.7.1 Sampling Plans and SOPs
When PAS performs field collection of samples, sampling is carried out in accordance with a
written sampling plan and sampling SOPs. These documents are made readily accessible at
the sampling location. Sampling plans and SOPs are, whenever reasonable, based on
appropriate governing methods and address the factors to be controlled to ensure the validity
of the analytical results.
5.7.2 Customer Requested Deviations
When the customer requires deviations, additions, or exclusions from the documented
sampling plan and/or procedure, the laboratory records the client’s change request in detail
with the sampling record, communicates the change to sampling personnel, and includes this
information in the final test report.
5.7.3 Recordkeeping
PAS assures the sampling record includes the sampling procedure used, any deviations from
the procedure, the date and time of sampling, the identification of the sampler, environmental
conditions (if relevant), and the sampling location.
5.8 Sample Management & Handling
5.8.1 Procedures
The location’s procedures for sample management and handling are outlined in SOP
ENV-SOP-MTJL-0045 Sample Dilution Policy, ENV-SOP-MTJL-0060 Sample Receiving,
ENV-SOP-MTJL-0061 Sample Storage, Disposal and Sample Control Technicians, ENV-SOP-
MTJL-0064 Sample Shipping, and ENV-SOP-MTJL-0066 Cold Storage Management.
The procedures in these SOPs are established to maintain the safe handling and integrity of
samples from transport, storage, to disposal and during all processing steps to maintain client
confidentiality, and to protect the interests of PAS and its customers.
5.8.1.1 Chain of Custody
All samples received by the location must be accompanied with a Chain of Custody
(COC) record. The COC provides information about the samples collected and
submitted for testing and documents the possession of samples from time of
collection to receipt by the location.
The COC record must minimally include the following information:
Client name, address, phone number;
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Project Reference;
Client Sample Identification (Client ID);
Date, Time, and Location of Sampling;
Sampler’s Name or Initials;
Matrix;
Type of container, and total number collected for each sample;
Preservatives;
Analyses Requested;
Mode of collection;
Any special instructions; and
The date and time and signature of each sample transfer from time of collection
to receipt in the location. When the signature field on CoC includes company.
Personnel relinquishing and/or receiving samples are expected to record this
information. When the COC is transported inside the cooler, independent
couriers do not sign the COC and the shipping manifests and/or air bills are the
records of possession during transport. The shipping manifest must be retained
as part of the COC record and included in the test report when required (See
Section 5.10.3).
A complete and legible COC is required. If the location observes that the COC is
incomplete or illegible, the client is contacted for resolution. The COC must be filled
out in indelible ink. Personnel correct errors by drawing a single line through the initial
entry, so the entry is not obscured, entering the correct information, and initialing,
and dating the change.
5.8.1.2 Legal Chain of Custody
Legal chain of custody is a chain of custody protocol used for evidentiary or legal
purposes. The protocol is followed by the location when requested by customer or
when mandated by a regulatory program.
Legal chain of custody (COC) protocol establishes an intact, continuous record of the
physical possession*, storage, and disposal of “samples” which includes sample
aliquots, and sample extracts/digestates/distillates.
Legal COC records account for all time periods associated with the samples and
identifies all individuals who physically handled individual samples. Legal COC begins
at the point established by legal authority, which is usually at the time the sample
containers are provided by the location for sample collect or when sample collection
begins.
*A sample is in someone’s custody if:
It is in one’s physical possession;
It is in one’s view after being in one’s physical possession;
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It has been in one’s physical possession and then locked or sealed so that no one
can tamper with it; and/or
It is kept in a secure area, restricted to authorized personnel only.
Refer to SOP ENV-SOP-MTJL-0060 Sample Receiving for more information.
5.8.2 Unique Identification
Each sample is assigned a unique identification number (Lab ID) after the sample has been
checked and accepted by PAS in accordance with the PAS sample acceptance policy (See
5.8.3). The Lab ID is affixed to the sample container using a durable label.
The unique identification of samples also applies to subsamples, and prepared samples.
The lab ID is linked to the field ID (client ID) in the receipt and log-in record. Both IDs are
linked to the testing activities performed on the sample and the documentation records of the
test.
Also see 5.8.4.
5.8.3 Sample Receipt Checks and Sample Acceptance Policy
The location checks the condition and integrity of samples on receipt and compares the labels
on the sample containers to the COC record. Any problem or discrepancy is recorded. If the
problem impacts the suitability of the sample for analysis or if the documentation is
incomplete, the client is notified for resolution. Decisions and instructions from the client are
maintained in the project record.
5.8.3.1 Sample Receipt Checks
The following checks are performed:
Verification that the COC is complete and legible.
Verification that each sample’s container label includes the client sample ID, the
date and time of collection and the preservative in indelible ink.
The container type and preservative are appropriate for each test requested.
Adequate volume is received for each test requested.
Visual inspection for damage or evidence of tampering.
Visual inspection for presence of headspace in VOA vials. (VOA = volatile
organic analysis).
Thermal Preservation: For chemical testing methods for which thermal
preservation is required, temperature on receipt is typically considered acceptable
if the measurement is above freezing but <6°C unless otherwise specified by
federal, statutory, program or test method requirements. Refer to the location’s
SOP for sample receipt for specific thermal preservation requirements.
For samples that are hand-delivered to the location immediately after sample
collection, there must be evidence that the chilling process began immediately
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after sample collection and prior to delivery of the samples to the laboratory or
service center, such as arrival of the samples on ice.
Chemical Preservation
Holding Time: Sample receiving personnel are trained to recognize tests where
the holding time is 48 hours or less and to expedite the log-in of these samples.
Except for tests with immediate holding times (15 minutes from time of
collection or less), when samples are received out of hold, the location will notify
the client and request instruction. If the decision is made to proceed with analysis,
the final test report will include notation of this instruction.
5.8.3.2 Sample Acceptance Policy
PAS maintains a sample acceptance policy in accordance with regulatory guidelines to
clearly establish the circumstances in which sample receipt is accepted or rejected.
When receipt does not meet criteria for any one of these conditions, the location must
document the noncompliance, contact the customer, and either reject the samples or
fully document any decisions to proceed with testing. In accordance with regulatory
specifications, test results associated with receipt conditions that do not meet criteria
are qualified in the final test report.
All samples received must meet each of the following criteria:
Be listed on a complete and legible COC;
Be received in properly labeled sample containers;
Be received in appropriate containers that identify preservative;
The COC must include the date and time of collection for each sample;
The COC must include the test method requested for each sample;
Be in appropriate sample containers with clear documentation of the
preservatives used;
Be received within holding time. Any samples received beyond the holding time
will not be processed without prior customer approval;
Have sufficient sample volume to proceed with the analytical testing. If
insufficient sample volume is received, analysis will not proceed without customer
approval; and
Be received within appropriate temperature ranges unless program requirements
or customer contractual obligations mandate otherwise.
Samples that are delivered to the location immediately after collection are
considered acceptable if there is evidence that the chilling process has been
started. For example, by the arrival of the samples on ice. If samples arrive that
are not compliant with these temperature requirements, the customer will be
notified. The analysis will NOT proceed unless otherwise directed by the
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customer. If less than 72 hours remain in the hold time for the analysis, the
analysis may be started while the customer is contacted to avoid missing the hold
time. Data associated with any deviations from the above sample acceptance
policy requirements will be appropriately qualified.
5.8.4 Sample Control and Tracking
The samples are controlled and tracked using the Laboratory Information Management
System (LIMS). The LIMS stores information about the samples and project. The process of
entering information into the LIMS is called log-in and these procedures are described in SOP
ENV-SOP-MTJL-0060 Sample Receiving. After log-in, a label is generated and affixed to
each sample container. Information on this label, such as the lab ID, links the sample container
to the information in LIMS.
At a minimum, the following information is entered during log-in:
Client Name and Contact Information;
The laboratory ID linked to the client ID;
Date and time of sample collection;
Date and time of sample receipt;
Matrix; and
Tests Requested.
5.8.5 Sample Storage, Handling, and Disposal
The location procedures for sample storage, handling and disposal are detailed in SOPs
ENV-SOP-MTJL-0061 Sample Storage, Disposal and Sample Control Technicians and ENVSOP-
MTJL-0066 Cold Storage Management as well as test method SOPs.
5.8.5.1 Sample Storage
The samples are stored according to method and regulatory requirements as per test
method SOPs. Samples are stored away from all standards, reagents, or other potential
sources of contamination and stored in a manner that prevents cross contamination.
Volatile samples are stored separately from other samples. All sample fractions,
extracts, leachates, and other sample preparation products are stored in the same
manner as actual samples or as specified by the analytical method.
Refrigerated storage areas are maintained at ≤6°C (but not frozen) and freezer storage
areas are maintained at <-10°C, unless otherwise required per method or program.
The temperature of each storage area is checked and documented at least once for
each day of use. If the temperature falls outside the acceptable limits, then corrective
actions are taken and appropriately documented.
The location is operated under controlled access protocols to ensure sample and data
integrity. Visitors must register at the front desk and be properly escorted while on-
site. Samples are taken to the appropriate storage location immediately after sample
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receipt and log-in procedures are completed. All sample storage areas have limited
access. Samples are removed from storage areas by designated personnel and returned
to the storage areas as soon as possible after the required sample quantity has been
taken.
5.8.5.2 Sample Retention and Disposal
The procedures used by the location for sample retention and disposal are detailed in
SOP ENV-SOP-MTJL-0061 Sample Storage, Disposal and Sample Control Technicians and
ENV-SOP-MTJL-0066 Cold Storage Management.
In general, unused sample volume and prepared samples such as extracts, digestates,
distillates and leachates (samples) are retained by the location for the timeframe
necessary to protect the interests of the location and the customer.
Samples may be stored at ambient temperature when all analyses are complete, the
hold time is expired, the report has been delivered, and/or when allowed by the
customer or program. Samples requiring storage beyond the minimum sample
retention time due to special requests or contractual obligations may be stored at
ambient temperature unless the location has a capacity, and their presence does not
compromise the integrity of other samples.
After this period expires, non-hazardous samples are properly disposed of as non-
hazardous waste. The preferred method for disposition of hazardous samples is to
return the excess sample to the customer.
5.9 Assuring the Quality of Test Results
5.9.1 Quality Control (QC) Procedures
The location monitors the validity and reliability of test results using quality control (QC)
samples that are prepared and analyzed concurrently with field samples in the same manner as
field samples. QC results are always associated to and reported with the field samples they
were prepared and analyzed with from the same preparation or analytical batch. See the
glossary for definition of preparation and analytical batch.
The results of QC performed during the testing process are used by the location to assure the
results of analysis are consistent, comparable, accurate, and/or precise within a specified limit.
When the results are not within acceptance criteria or expectations for method performance,
correction and corrective action(s) are taken. These actions may include retesting or reporting
of data with qualification to alert the end user of the situation.
Other QC measures performed include the use of certified reference materials (see 5.6.4),
participation in interlaboratory proficiency testing (see 5.9.1.2), verification that formulae used
for reduction of data and calculation of results is accurate (see 5.9.3), on-going monitoring of
environmental conditions that could impact test results (see 5.3.2), and evaluation and
verification of method selectivity and sensitivity (see 5.4.5).
QC results are also used by the location to monitor performance statistical trends over time
and to establish acceptance criteria when no method or regulatory criteria exist. (See 5.9.1.1.9)).
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5.9.1.1 Essential QC
Although the general principles of QC for the testing process apply to all testing, the
QC protocol used for each test depends on the type of test performed.
QC protocol used by the location to monitor the validity of the test are specified in
test method SOPs. The SOP includes QC type, frequency, acceptance criteria,
corrective actions, and procedures for reporting of nonconforming work.
These requirements in the SOP conform to the reference method and any applicable
regulations or certification and accreditation program requirement for which results
of the test are used. When a project requires more stringent QC protocol than
specified in the SOP, project specification is followed. When the project requires less
stringent QC protocol, the project specification may be followed as an authorized
departure from the SOP when the project specifications meet the requirements in the
mandated method and any regulatory compliance requirements for which the data
will be used.
The following are examples of essential QC for chemistry. These concepts may not
apply to other technologies and disciplines such as microbiology, radiochemistry,
whole effluent toxicity, and/or asbestos. For essential QC for these disciplines, refer
to test method SOPs.
5.9.1.1.1 Second Source Standard (ICV/QCS)
The second source standard is a standard obtained from a different
vendor than the vendor of the standards used for calibration, or
from a different lot from the same vendor, when only one vendor is
available. It is a positive control used to verify the accuracy of
instrument calibration relative to the purity of the standards used for
calibration. This check may be referred to in published test methods
and quality system standards as the initial calibration verification
(ICV) or a quality control sample (QCS). The second source
standard is analyzed immediately after the calibration and before
analysis of any samples. When the ICV is not within acceptance
criteria, a problem with the purity or preparation of the standards
may be indicated. The source of the problem should be investigated
and corrected prior to further use of the calibration/instrument for
sample analysis.
5.9.1.1.2 Continuing Calibration Verification (CCV)
The CCV is used to determine if the analytical response has
significantly changed since calibration. If the response of the CCV is
within criteria, the calibration is considered valid. If not, there is a
problem that requires further investigation and correction. Actions
taken are technology and method specific.
5.9.1.1.3 Method Blank (MB) / Other Blanks
The MB is a negative control used to assess for contamination during
the prep/analysis process. The MB consists of a clean matrix, similar
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to the associated samples that is known to be free of analytes of
interest. The MB, unless otherwise specified by the test method, is
processed with, and carried through all preparation and analytical
steps as the associated samples.
The criteria used to assess for contamination depends on the
intended use of data. In general, detections in the MB above the RL
or ½ the RL indicate contamination. When contamination is evident,
the source is investigated, and corrections are taken to reduce or
eliminate it. Analytical results associated with MB that does not meet
criteria are qualified in the final test report.
Other types of blanks that serve as negative controls in the process
may include:
Trip Blanks (VOA)
Storage Blanks
Equipment Blanks
Field Blanks
Calibration Blanks
Cleanup Blanks
Instrument Blanks
5.9.1.1.4 Laboratory Control Sample (LCS)
The LCS is a positive control used to measure the accuracy of
process in a blank matrix. The LCS is spiked by the laboratory with
a known amount of analyte. The spike is a standard solution that is
pre-made or prepared from a certified reference standard. Like the
MB, unless otherwise specified in the test method, the LCS is
processed with and carried through all preparation and analytical
steps as the associated samples.
When the percent recovery (%R) of the LCS is within the established
control limit, sufficient accuracy has been achieved. If not, the
source of the problem is investigated and corrected, and the
procedure may be repeated. Analytical results associated with LCS
that does not meet criteria are qualified in the final test report.
5.9.1.1.5 Matrix Spike (MS) and Matrix Spike Duplicate (MSD)
The MS and MSD are replicates of a client sample that is spiked with
known amount of target analyte. Matrix spikes measure the effect
the sample matrix has on precision and accuracy of test results.
Matrix spike results mostly provide information on the effect of the
matrix to the client whose sample was used and on samples of the
same matrix from the same sampling site, during the same sampling
event. Consequently, matrix spikes should be client designated.
When there is not a client-specified MS for any sample in the batch,
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the location randomly selects a sample from the batch; the sample
selected at random is called a “batch” matrix spike.
The MS/MSD results for percent recovery and relative percent
difference are checked against control limits. However, because the
performance of matrix spikes is matrix-dependent and specific to the
customer whose sample was used as the MS/MSD, the results of
matrix spikes are not used for quality control on the batch.
5.9.1.1.6 Sample Duplicate (SD)
A sample duplicate is a second replicate of sample that is used to
measure precision.
The relative percent difference between replicates are evaluated
against the established acceptance criteria for relative percent
difference (RPD) when this criterion is applicable. If RPD is not met,
associated test results are reported with qualification.
5.9.1.1.7 Surrogates
Surrogates are compounds that mimic the chemistry of target
analytes but are not expected to occur naturally in real world
samples. Surrogates are added to each sample and matrix QC
samples (MS, MSD, SD) at known concentration to measure the
impact of the matrix on the accuracy of method performance.
Surrogates are also added to the positive and negative control
samples (MB, LCS) to evaluate performance in a clean matrix, and
included in the calibration standards and calibration check standards.
The percent recovery of surrogates is evaluated against method-
specified limits or statistically derived in-house limits. Project-
specific limits and/or program-specific limits are used when
required. Results with surrogate recovery out of limits in samples are
reported with qualification. Samples with surrogate failures can also
be re-extracted and/or re-analyzed to confirm that the out-of-
control value was caused by the matrix of the sample and not by
some other systematic error.
5.9.1.1.8 Internal Standards
Internal Standards are compounds not expected to occur naturally
in field samples. They are added to every standard and sample at a
known concentration prior to analysis for the purpose of adjusting
the response factor used in quantifying target analytes. The location
follows specific guidelines for the treatment of internal standard
recoveries and further information can be found in the applicable
test method SOP.
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5.9.1.1.9 QC Acceptance Criteria and Control Limits
The QC acceptance criteria are specified in test method SOPs. The
criteria in the SOP are based on the requirements in the published
test method or regulatory program. When there are no established
acceptance criteria, the location develops acceptance criteria in
accordance with recognized industry standards.
Some methods and programs require the location to establish
control limits for LCS, MS/MSD, and surrogate evaluation using
historical data. PAS developed limits are referred to as “in-house”
control limits. In-house control limits represent ± 3 Standard
Deviations (99% confidence level) from the average recovery of at
least 20 data points generated using the same preparation and
analytical procedure in a similar matrix.
See SOP ENV-SOP-MTJL-0017 Generation of Control Limits for more
information about the procedures used to establish in-house control
limits.
5.9.1.2 Proficiency Testing (PT)
PAS locations participate in interlaboratory proficiency testing (PT) studies to
measure performance of the test method and to identify or solve analytical problems.
PT samples measure location performance through the analysis of unknown samples
provided by an external source.
The frequency of PT participation is based on the certification and accreditation
requirements held by the laboratory. The PT samples are obtained from accredited
proficiency testing providers (PTP) and treated as field samples which means they are
included in the location’s normal analytical processes and do not receive extraordinary
attention due to their nature.
PAS locations do not share PT samples with other PAS locations, does not
communicate with other PAS locations regarding current PT sample results during
the duration of the study, and does not attempt to obtain the assigned value of any
PT sample from the PT provider.
PT results scored unacceptable are investigated and correction action taken, when
necessary.
Refer to corporate policy ENV-POL-CORQ-0002 PT Policy for more information.
5.9.2 QC Corrective Action
When the results of QC are not within acceptance criteria or expectations for method
performance, correction and corrective action(s) are taken per the specifications in the test
method SOP. These actions may include retesting or reporting of data with qualification to
alert the end user of the situation.
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5.9.3 Data Review
PAS locations use a tiered system for data review. The tiered process provides sequential
checks to verify data transfer is complete; manual calculations, if performed, are correct,
manual integrations are appropriate and documented, calibration and QC requirements are
met, appropriate corrective action was taken when required, test results are properly qualified,
process and test method SOPs were followed, project specific requirements were met, when
applicable, and the test report is complete.
The sequential process includes three tiers referred to as primary review, secondary review,
and administrative/completeness review.
Detailed procedures for the data review process are described in SOP ENV-SOP-MTJL-0038
Data Review. The general expectations for the tiered review process are described in the
following sections:
5.9.3.1 Primary Review
Primary review is performed by the individual that performed the task. All PAS
personnel are responsible for review of their work product to assure it is complete,
accurate, documented, and consistent with policy and SOPs.
Checks performed during primary review include but are not limited to:
Verification that data transfer and acquisition is complete
Manual calculations, if performed, are documented and accurate
Manual integrations, if performed, are documented, and comply with SOP ENV-
SOP-CORQ-006 Manual Integration
Calibration and QC criteria were met, and/or proper correction and corrective
actions were taken, and data and test results associated with QC and criteria
exceptions are properly qualified
Work is consistent with SOPs and any other relevant instructional document such
as SWI, program requirements, or project QAPP
5.9.3.2 Secondary Review
Secondary review is performed by a qualified peer or supervisor. Secondary review is
a repeat of the checks performed during primary review by another person. In
addition to the checks of primary review, secondary review includes chromatography
review to check the accuracy of quantitative analyte identification.
5.9.3.3 Completeness Review
Completeness review is an administrative review performed prior to release of the test
report to the customer. Completeness review verifies that the final test report is
complete and meets project specification. This review also assures that information
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necessary for the client’s interpretation of results are explained in the case narrative
or footnoted in the test report.
5.9.3.4 Data Audits
Test reports may be audited by local quality personnel to verify compliance with SOPs
and to check for data integrity, technical accuracy, and compliance with the PAS QMS
and any applicable federal, statutory, and program requirements. The reports chosen
for the data audits are selected at random and these audits are not usually done prior
to issuance of the test report to the customer.
If any problems with the data or test results are found during the data audit, the impact
of the nonconforming work is evaluated using the process described in Section 4.9.
Also see Section 4.14 for internal audits.
5.9.4 Calibration Certificates
PAS does not perform calibration activities for its customers and calibration certificates are
not offered or issued.
5.9.5 Opinions and Interpretations
The location provides objective data and information to its customers of sufficient detail for
their interpretation and decision making. Objective data and information are based solely on
fact and does not attempt to explain the meaning (interpret) or offer a view or judgement
(opinion). Sometimes the customer may request the location provide opinion or interpretation
to assist them with their decisions about the data.
When opinions and interpretations are included in the test report, the location will document
the basis upon which the opinions and interpretations have been made and clearly identify this
content as opinion or interpretation in the test report.
Examples of opinion and interpretation include but are not limited to:
A viewpoint on how a nonconformance impacts the quality of the data or usability of
results.
Recommendations for how the customer should use the test results and information.
Suggestions or guidance to the customer for improvement.
5.9.6 Subcontractor Reports
When analytical work has been subcontracted to an organization external to PAS, the test
report from the subcontractor is included in its entirety as an amendment to the final test
report.
Test results performed by multiple locations within the PAS network (internal subcontracting)
may be merged into a single test report so long as the test report issued clearly identifies the
location and address of each network location that performed testing, and which tests each
PAS location performed. (See 5.10.2)
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5.9.7 Electronic Transmission of Results
When test results and/or reports are submitted to the customer through electronic
transmission, the procedures established in this manual for confidentiality and protection of
data apply.
5.9.8 Format of Test Reports
The test formats offered by PAS are designed to accommodate each type of analytical test
method performed and to minimize the possibility of misunderstanding or misuse of analytical
results. The format of electronic data deliverables (EDD) follows the specifications for the
EDD.
5.9.9 Amendments to Test Reports
Test reports that are revised or amended by the location after date of release of the original
final test report to the customer are issued as a new test report that is clearly identified as an
amendment or revision and that includes a reference to the originally issued final test report.
The customer is the organization doing business with PAS external to PAS.
Changes made to test results and data before the final test report is issued to the customer are
not amendments or revisions, these are corrections to errors found during the location’s data
verification and review process.
The procedure for report amendments and revision are outlined in SOP ENV-SOP-MTJL-
0014 Data Handling and Reporting and ENV-SOP-MTJL-0033 Report Revision.
5.10 Reporting
5.10.1 General Requirements
PAS offers a wide variety of test report formats to meet project needs of Pace® customers
and that comply with federal and state regulatory programs.
The type and level of deliverable, including the electronic data deliverable (EDD) format are
established between PAS and the customer during the contracting process. The report
specifications include the test report format, protocol for the reporting limit (RL), conventions
for the reporting of results less than the limit of quantitation (LOQ), and specification for the
use of project or program specific data qualifiers. Information about review of analytical
service requests is provided in Section 4.4.
5.10.2 Test Reports: Required Items
Regardless of deliverable or report requested, every test report issued by the location includes
each of the following items:
a) A Title
b) The name and address of the location issuing the test report and for each location where
testing was performed if different than address of the location issuing the report. When
testing is done at multiple PAS locations, the report must clearly identify which PAS
location performed each test method;
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c) Unique identification of the test report and on each page an identification number to link
each page to the test report, and clear identification of the end of the report.
d) The name and address of the customer
e) Identification of test methods used
f) Cross reference between client sample identification number (Sample ID) and the
identification number for the sample (Lab ID) to provide unambiguous identification of
samples.
g) The date of receipt of samples, condition of samples on receipt, and identification of any
instance where receipt of the samples did not meet sample acceptance criteria.
h) Date and times of sample collection, receipt, preparation, and analysis.
i) Test results and units of measurement, and qualification of results associated with QC
criteria exceptions, and identification of reported results outside of the calibration range.
j) All chains of custody (COC) including records of internal transfer between locations
within PAS,
k) Name, title, signature of the person(s) authorizing release of the test report and date of
release.
l) A statement that the results in the test report relate only to the items tested.
m) Statement that the test report may not be reproduced except in full without written
approval from PAS.
5.10.3 Test Reports: Supplemental Items
5.10.3.1 Supplemental Requirements
The following items are included in the test report when required or relevant:
a) Shipping manifests / bill of ladings as applicable when common couriers are
utilized for shipment of samples,
b) Explanation of departure from test method SOPs including, what the departure
was and why it was necessary.
c) Statistical methods used. (Required for Whole Effluent Toxicity)
d) For solid samples, specification that results are reported on a dry weight or wet
weight basis.
e) Signed Affidavit, when required by client or regulatory agency.
f) A statement of compliance / non-compliance with requirements or specifications
(client, program, or standard) that includes identification of test results that did
not meet acceptance criteria.
g) When requested by the client, statement of estimated measurement uncertainty.
In general, for environmental testing, estimated uncertainty of measurement is
extrapolated from LCS control limits. Control limits incorporate the expected
variation of the data derived from the laboratory’s procedure. When the control
limits are specified by the test method or regulatory program, the control limits
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represent the expected variation of the test method and/or matrices for which
the test method was designed.
h) Opinions and Interpretations
i) If a claim of accreditation/certification is included in the test report, identification
of any test methods or analytes for which accreditation/certification is not held
by the location if the accrediting body offers accreditation/certification for the
test method/analyte. The fields of accreditation/certification vary between
agencies, and it cannot be presumed that because accreditation/certification is
not held that it is offered or required.
j) Certification Information, including certificate number and issuing body.
For PAS locations accredited to ISO/IEC 17025:2017:
Data included in the test report provided by a customer should be clearly
identified. The test report should also include a statement that the test results
apply only to the samples as received.
5.10.3.2 Test Reports: Sampling Information
The following items are included in the test report when samples are collected by PAS
or when this information is necessary for the interpretation of test results:
a) Date of Sampling.
b) Unambiguous identification of material samples.
c) Location of sampling including diagrams, sketches, or photographs.
d) Reference to the sampling plan and procedures used.
e) Details of environmental conditions at time of sample that may impact test
results.
f) Any standard or other specification for the sampling method or procedure, and
deviations, additions to or exclusions from the specification concerned.
6.0 REVISION HISTORY
This Version (Version 2):
Section Description of Change
Header / All Added registered trademark after Pace as required by branding guidelines
Header Updated the years associated with the copyright.
Signature Page Removed Cover Page applied by MasterControl eDMS
Approval Signatory Changed name of this page to “Management Personnel” and updated Job Titles.
All Changed references to “laboratory” with PAS or location, where appropriate.
All Replaced stand-alone acronym “ENV” with “PAS” except where “ENV” is
embedded in document control numbers.
All Corrected spelling, typographical, and format errors.
Various
Added language to clarify the examples in the manual are provided for chemistry,
these examples may not apply in the same way to other disciplines such as
radiochemistry, microbiology, asbestos, or whole effluent toxicity (WET).
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1.0 Corrected Parent Company Information.
1.2 Added definitions for “location,” “laboratory” and “service center” for QMS and
compliance purposes.
1.2.1 Updated job titles to match current structure.
1.2.2 Revised language for clarity.
1.2.3 Removed specificity to allow for more options
4.1.4 Updated to describe current scope of organization
4.1.4.1 Updated to describe current organization structure
4.1.5.1.1 Updated to match new organization structure and job titles
4.1.5.2 Updated to match new organization structure and job titles
4.1.5.2.1 Updated to clarify qualifications and meaning of “absent”
4.1.5.3 Updated to clarify impartiality
4.1.5.4 Reorganized section for clarity
4.2.1.1 Added statement that the organization structure is designed to safeguard impartiality
4.2.2.1 Added requirement to post compliance alertline posters in work area.
4.2.1.3 Added requirement for policies and procedures to be available in work area
(previously implied but not explicitly stated)
4.2.5.1 Clarified hierarchy and application of project documents
4.5 Updated requirements for internal and external subcontracting
4.8 Updated complaint handling requirements to clarify that only valid complaints are
acted on with corrective action.
4.9.1.3 Added roles responsible for authorizing return to work after stop work order.
4.11 Main and subsections updated for clarity
4.14 Main and subsections updated for clarity
5.2.2 Subsections
Content reorganized and language related to documentation of training and
authorization of personnel revised to clarify expectations. Requirements of DOCs
modified to clarify procedure described in manual pertains to chemistry
methodology; other approaches to DOC acceptable for other disciplines such as
microbiology, radiochemistry, asbestos, whole effluent toxicity.
5.4.5.3.3 Added reference documents for which the local SOP for LOD must comply with.
5.5 Added language to clarify existing requirements.
5.6.4
Clarified requirements for reference standards for working weights and
thermometers and defined meaning of terms “annual” and “quarterly.” Included
examples of acceptable reference standards for adequacy checks.
5.8.1
Added recommendation for Pace® personnel to add “Pace®” next to their
signature on the CoC when receiving samples since the CoC form has
signature/company, implying the company affiliation must be added.
5.10.3.1 Included ISO/IEC 17025:2017 to add disclaimer to test reports (applies to
laboratories accredited to ISO/IEC 17025:2017 only).
Addendum Added AIHA, Radiological and Calculation addendums
This document supersedes the following documents:
Document Number Title Version
ENV-MAN-MTJL-0001 Quality Manual 02
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7.0 APPENDICES
7.1 Appendix A: Certification / Accreditation Listing
Disclaimer: The certifications / accreditation lists provided in this Appendix are those that were held by the
PAS location on the effective date of this manual. This information is subject to change without notice and
must not be considered valid proof of certification or accreditation status. This manual is not updated with each
change made. Current certificates are accessible via the eDMS Portal for PAS employees. External parties should
contact the location for the most current information.
7.1.1 PAS-Mt. Juliet
Authority ID Authority ID
Alabama 40660 North Carolina Env375
Alaska UST-080 North Dakota R-140
Arizona AZ0612 Ohio EPA/VAP CL0069
Arkansas 88-0469 Oklahoma 9915
California 2932 Oregon TN200002
Colorado None Pennsylvania 68-02979
Connecticut PH-0197 Rhode Island 221
Florida E87487 South Carolina 84004
Georgia DW 923 South Dakota Pending
Georgia None Tennessee DW 2006
Idaho TN00003 Tennessee DW Micro 2006
Illinois 200008 Texas-Env.T 104704245-07-TX
Indiana C-TN-01 Texas-Mold LAB0152
Iowa 364 Utah TN000032019-9
Kansas E-10277 Vermont VT2006
Kentucky DW 90010 Virginia VELAP 460132
Kentucky UST 16 Washington C1915
Kentucky WW 90010 West Virginia 233
Louisiana Agency ID 30792 West Virginia Crypto 9966 M
Louisiana DW LA150002 Wisconsin 998093910
Maine TN0002 Wyoming A2LA
Maryland 324 A2LA 1461.01
Massachusetts M-TN003 AIHA-LAP 100789
Michigan 9958 DOD 1461.01
Minnesota 047-999-395 EPA TN00003
Mississippi None EPA Region 8
Missouri 340 USDA S-67674
Montana CERT0086
Nebraska NA
Nevada TN-03-2002-34
New Hampshire 2975
New Jersey-NELAP TN002
New Mexico None
New York 11742
North Carolina
Aquatic Tox.
41
North Carolina DW DW21704
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7.2 Appendix B: Capability Listing
The capabilities listed in this Appendix were held by the location referenced on the effective date of
this manual. This information is subject to change without notice. External parties should contact the
location for the most current information.
Table Legend:
Air = Air
DW = Drinking Water
NPW = Non-Potable Water
SCM = Solid and Chemical Materials
Waste = Non-Aqueous Phase Liquid (NAPL), Oil
Tissue = Biota and Tissue
7.2.1 PAS-Mt. Juliet
MatricesParameterMethod
Air DW NPW SCM Waste Tissue
1,1,1,2-Tetrachloroethane EPA 5030 X
1,1,1,2-Tetrachloroethane EPA 624.1 X
1,1,1,2-Tetrachloroethane EPA 8260B X X
1,1,1,2-Tetrachloroethane EPA 8260C X X
1,1,1,2-Tetrachloroethane EPA 8260D X X
1,1,1,2-Tetrachloroethane SM 6200 B-2011 X
1,1,1,2-Tetrachloroethane EPA 524.2 X
1,1,1-Trichloroethane EPA 624.1 X
1,1,1-Trichloroethane EPA 8260B X X
1,1,1-Trichloroethane EPA 8260C X X
1,1,1-Trichloroethane EPA 8260D X X
1,1,1-Trichloroethane EPA TO-15 X
1,1,1-Trichloroethane
EPA TO-15 GC/MS
SIM X
1,1,1-Trichloroethane SM 6200 B-2011 X
1,1,1-Trichloroethane EPA 524.2 X
1,1,2,2-Tetrachloroethane EPA 624.1 X
1,1,2,2-Tetrachloroethane EPA 8260B X X
1,1,2,2-Tetrachloroethane EPA 8260C X X
1,1,2,2-Tetrachloroethane EPA 8260D X X
1,1,2,2-Tetrachloroethane EPA TO-15 X
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1,1,2,2-Tetrachloroethane
EPA TO-15 GC/MS
SIM X
1,1,2,2-Tetrachloroethane SM 6200 B-2011 X
1,1,2,2-Tetrachloroethane EPA 524.2 X
1,1,2-Trichloro-1,2,2-
trifluoroethane (Freon 113)EPA 624.1 X
1,1,2-Trichloro-1,2,2-
trifluoroethane (Freon 113)EPA 8260B X X
1,1,2-Trichloro-1,2,2-
trifluoroethane (Freon 113)EPA 8260C X X
1,1,2-Trichloro-1,2,2-
trifluoroethane (Freon 113)EPA 8260D X X
1,1,2-Trichloro-1,2,2-
trifluoroethane (Freon 113)EPA TO-15 X
1,1,2-Trichloro-1,2,2-
trifluoroethane (Freon 113)SM 6200 B-2011 X
1,1,2-Trichloroethane EPA 624.1 X
1,1,2-Trichloroethane EPA 8260B X X
1,1,2-Trichloroethane EPA 8260C X X
1,1,2-Trichloroethane EPA 8260D X X
1,1,2-Trichloroethane EPA TO-15 X
1,1,2-Trichloroethane
EPA TO-15 GC/MS
SIM X
1,1,2-Trichloroethane SM 6200 B-2011 X
1,1,2-Trichloroethane EPA 524.2 X
1,1'-Biphenyl (BZ-0) (Biphenyl)EPA 8270C X X
1,1'-Biphenyl (BZ-0) (Biphenyl)EPA 8270D X
1,1-Dichloroethane EPA 624.1 X
1,1-Dichloroethane EPA 8260B X X
1,1-Dichloroethane EPA 8260C X X
1,1-Dichloroethane EPA 8260D X X
1,1-Dichloroethane EPA TO-15 X
1,1-Dichloroethane
EPA TO-15 GC/MS
SIM X
1,1-Dichloroethane SM 6200 B-2011 X
1,1-Dichloroethane EPA 524.2 X
1,1-Dichloroethene EPA 524.2 X
1,1-Dichloroethylene EPA 624.1 X
1,1-Dichloroethylene EPA 8260B X X
1,1-Dichloroethylene EPA 8260C X X
1,1-Dichloroethylene EPA 8260D X X
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1,1-Dichloroethylene EPA TO-15 X
1,1-Dichloroethylene
EPA TO-15 GC/MS
SIM X
1,1-Dichloroethylene SM 6200 B-2011 X
1,1-Dichloropropene EPA 524.2 X
1,1-Dichloropropene EPA 624 (extended) X
1,1-Dichloropropene EPA 624.1 X
1,1-Dichloropropene EPA 8260B X X
1,1-Dichloropropene EPA 8260C X X
1,1-Dichloropropene EPA 8260D X X
1,1-Dichloropropene SM 6200 B-2011 X
1,1-dimethylethyl ester (tert-
Butyl Formate)EPA 8260B X X
1,1-dimethylethyl ester (tert-
Butyl Formate)EPA 8260C X
1,1-dimethylethyl ester (tert-
Butyl Formate)EPA 8260D X
1,2,3,4-Tetrachlorobenzene EPA 8270C X X
1,2,3,4-Tetrachlorobenzene EPA 8270D X X
1,2,3,4-Tetrachlorobenzene EPA 8270E X X
1,2,3,5-Tetrachlorobenzene EPA 625.1 X
1,2,3,5-Tetrachlorobenzene EPA 8270C X X
1,2,3,5-Tetrachlorobenzene EPA 8270D X X
1,2,3,5-Tetrachlorobenzene EPA 8270E X X
1,2,3-Trichlorobenzene EPA 524.2 X
1,2,3-Trichlorobenzene EPA 624 (extended) X
1,2,3-Trichlorobenzene EPA 624.1 X
1,2,3-Trichlorobenzene EPA 8260B X X
1,2,3-Trichlorobenzene EPA 8260C X X
1,2,3-Trichlorobenzene EPA 8260D X X
1,2,3-Trichlorobenzene SM 6200 B-2011 X
1,2,3-Trichloropropane EPA 504.1 X
1,2,3-Trichloropropane EPA 624.1 X
1,2,3-Trichloropropane EPA 8260B X X
1,2,3-Trichloropropane EPA 8260C X X
1,2,3-Trichloropropane EPA 8260D X X
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1,2,3-Trichloropropane SM 6200 B-2011 X
1,2,3-Trichloropropane EPA 524.2 X
1,2,3-Trimethylbenzene EPA 624.1 X
1,2,3-Trimethylbenzene EPA 8260B X X
1,2,3-Trimethylbenzene EPA 8260C X X
1,2,3-Trimethylbenzene EPA 8260D X X
1,2,3-Trimethylbenzene EPA TO-15 X
1,2,4,5-Tetrachlorobenzene EPA 625.1 X
1,2,4,5-Tetrachlorobenzene EPA 8270C X X
1,2,4,5-Tetrachlorobenzene EPA 8270D X X
1,2,4,5-Tetrachlorobenzene EPA 8270E X X
1,2,4-Trichlorobenzene EPA 624.1 X
1,2,4-Trichlorobenzene EPA 625.1 X
1,2,4-Trichlorobenzene EPA 8260B X X
1,2,4-Trichlorobenzene EPA 8260C X X
1,2,4-Trichlorobenzene EPA 8260D X X
1,2,4-Trichlorobenzene EPA 8270C X X
1,2,4-Trichlorobenzene EPA 8270D X X
1,2,4-Trichlorobenzene EPA 8270E X X
1,2,4-Trichlorobenzene EPA TO-15 X
1,2,4-Trichlorobenzene SM 6200 B-2011 X
1,2,4-Trichlorobenzene EPA 524.2 X
1,2,4-Trimethylbenzene EPA 624.1 X
1,2,4-Trimethylbenzene EPA 8260B X X
1,2,4-Trimethylbenzene EPA 8260C X X
1,2,4-Trimethylbenzene EPA 8260D X X
1,2,4-Trimethylbenzene EPA TO-15 X
1,2,4-Trimethylbenzene SM 6200 B-2011 X
1,2,4-Trimethylbenzene EPA 524.2 X
1,2-Dibromo-3-chloropropane EPA 504.1 X
1,2-Dibromo-3-chloropropane EPA 524.2 X
1,2-Dibromo-3-chloropropane
(DBCP)EPA 624.1 X
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1,2-Dibromo-3-chloropropane
(DBCP)EPA 8011 X X
1,2-Dibromo-3-chloropropane
(DBCP)EPA 8260B X X
1,2-Dibromo-3-chloropropane
(DBCP)EPA 8260C X X
1,2-Dibromo-3-chloropropane
(DBCP)EPA 8260D X X
1,2-Dibromo-3-chloropropane
(DBCP)SM 6200 B-2011 X
1,2-Dibromoethane EPA 504.1 X
1,2-Dibromoethane EPA 524.2 X
1,2-Dibromoethane (EDB,
Ethylene dibromide)EPA 624.1 X
1,2-Dibromoethane (EDB,
Ethylene dibromide)EPA 8011 X X
1,2-Dibromoethane (EDB,
Ethylene dibromide)EPA 8260B X X
1,2-Dibromoethane (EDB,
Ethylene dibromide)EPA 8260C X X
1,2-Dibromoethane (EDB,
Ethylene dibromide)EPA 8260D X X
1,2-Dibromoethane (EDB,
Ethylene dibromide)EPA TO-15 X
1,2-Dibromoethane (EDB,
Ethylene dibromide)
EPA TO-15 GC/MS
SIM X
1,2-Dibromoethane (EDB,
Ethylene dibromide)SM 6200 B-2011 X
1,2-Dichloro-1,1,2,2-
tetrafluoroethane (Freon-114)EPA TO-15 X
1,2-Dichlorobenzene EPA 624.1 X
1,2-Dichlorobenzene EPA 625.1 X
1,2-Dichlorobenzene EPA 8260B X X
1,2-Dichlorobenzene EPA 8260C X X
1,2-Dichlorobenzene EPA 8260D X X
1,2-Dichlorobenzene EPA 8270C X X
1,2-Dichlorobenzene EPA 8270D X X
1,2-Dichlorobenzene EPA 8270E X X
1,2-Dichlorobenzene EPA TO-15 X
1,2-Dichlorobenzene SM 6200 B-2011 X
1,2-Dichlorobenzene EPA 524.2 X
1,2-Dichloroethane EPA 524.2 X
1,2-Dichloroethane (Ethylene
dichloride)EPA 624.1 X
1,2-Dichloroethane (Ethylene
dichloride)EPA 8260B X X
1,2-Dichloroethane (Ethylene
dichloride)EPA 8260C X X
1,2-Dichloroethane (Ethylene
dichloride)EPA 8260D X X
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1,2-Dichloroethane (Ethylene
dichloride)EPA TO-15 X
1,2-Dichloroethane (Ethylene
dichloride)
EPA TO-15 GC/MS
SIM X
1,2-Dichloroethane (Ethylene
dichloride)SM 6200 B-2011 X
1,2-Dichloropropane EPA 624.1 X
1,2-Dichloropropane EPA 8260B X X
1,2-Dichloropropane EPA 8260C X X
1,2-Dichloropropane EPA 8260D X X
1,2-Dichloropropane EPA TO-15 X
1,2-Dichloropropane
EPA TO-15 GC/MS
SIM X
1,2-Dichloropropane SM 6200 B-2011 X
1,2-Dichloropropane EPA 524.2 X
1,2-Diphenylhydrazine EPA 625.1 X
1,2-Diphenylhydrazine EPA 8270C X X
1,2-Diphenylhydrazine EPA 8270D X X
1,2-Diphenylhydrazine EPA 8270E X X
1,3,5-Trimethylbenzene EPA 524.2 X
1,3,5-Trimethylbenzene EPA 624.1 X
1,3,5-Trimethylbenzene EPA 8260B X X
1,3,5-Trimethylbenzene EPA 8260C X X
1,3,5-Trimethylbenzene EPA 8260D X X
1,3,5-Trimethylbenzene EPA TO-15 X
1,3,5-Trimethylbenzene SM 6200 B-2011 X
1,3,5-Trinitrobenzene (1,3,5-
TNB)EPA 625.1 X
1,3,5-Trinitrobenzene (1,3,5-
TNB)EPA 8270C X X
1,3,5-Trinitrobenzene (1,3,5-
TNB)EPA 8270D X X
1,3,5-Trinitrobenzene (1,3,5-
TNB)EPA 8270E X X
1,3,5-Trinitrobenzene (1,3,5-
TNB)EPA 8330 X X
1,3,5-Trinitrobenzene (1,3,5-
TNB)EPA 8330A X X
1,3,5-Trinitrobenzene (1,3,5-
TNB)EPA 8330B X X
1,3-Butadiene EPA 624.1 X
1,3-Butadiene EPA 8260B X
1,3-Butadiene EPA 8260C X
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1,3-Butadiene EPA 8260D X
1,3-Butadiene EPA TO-15 X
1,3-Dichlorobenzene EPA 624.1 X
1,3-Dichlorobenzene EPA 625.1 X
1,3-Dichlorobenzene EPA 8260B X X
1,3-Dichlorobenzene EPA 8260C X X
1,3-Dichlorobenzene EPA 8260D X X
1,3-Dichlorobenzene EPA 8270C X X
1,3-Dichlorobenzene EPA 8270D X X
1,3-Dichlorobenzene EPA 8270E X X
1,3-Dichlorobenzene EPA TO-15 X
1,3-Dichlorobenzene SM 6200 B-2011 X
1,3-Dichlorobenzene EPA 524.2 X
1,3-Dichloropropane EPA 624 (extended) X
1,3-Dichloropropane EPA 624.1 X
1,3-Dichloropropane EPA 8260B X X
1,3-Dichloropropane EPA 8260C X X
1,3-Dichloropropane EPA 8260D X X
1,3-Dichloropropane SM 6200 B-2011 X
1,3-Dichloropropane EPA 524.2 X
1,3-Dichloropropene EPA 624 (extended) X
1,3-Dinitrobenzene (1,3-DNB)EPA 625.1 X
1,3-Dinitrobenzene (1,3-DNB)EPA 8270C X X
1,3-Dinitrobenzene (1,3-DNB)EPA 8270D X X
1,3-Dinitrobenzene (1,3-DNB)EPA 8270E X X
1,3-Dinitrobenzene (1,3-DNB)EPA 8330 X X
1,3-Dinitrobenzene (1,3-DNB)EPA 8330A X X
1,3-Dinitrobenzene (1,3-DNB)EPA 8330B X X
1,3-Hexachlorobutadiene EPA 8260B X
1,3-Hexachlorobutadiene EPA 8260C X
1,3-Hexachlorobutadiene EPA 8260D X
1,3-Hexachlorobutadiene EPA 8270D X
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1,3-Hexachlorobutadiene EPA 8270E X
1,3-Hexachlorobutadiene EPA TO-15 X
1,4-Dichlorobenzene EPA 624.1 X
1,4-Dichlorobenzene EPA 625.1 X
1,4-Dichlorobenzene EPA 8260B X X
1,4-Dichlorobenzene EPA 8260C X X
1,4-Dichlorobenzene EPA 8260D X X
1,4-Dichlorobenzene EPA 8270C X X
1,4-Dichlorobenzene EPA 8270D X X
1,4-Dichlorobenzene EPA 8270E X X
1,4-Dichlorobenzene EPA TO-15 X
1,4-Dichlorobenzene
EPA TO-15 GC/MS
SIM X
1,4-Dichlorobenzene SM 6200 B-2011 X
1,4-Dichlorobenzene EPA 524.2 X
1,4-Dinitrobenzene EPA 625.1 X
1,4-Dinitrobenzene EPA 8270C X X
1,4-Dinitrobenzene EPA 8270D X X
1,4-Dinitrobenzene EPA 8270E X X
1,4-Dioxane (1,4-
Diethyleneoxide)EPA 624.1 X
1,4-Dioxane (1,4-
Diethyleneoxide)EPA 625.1 SIM X
1,4-Dioxane (1,4-
Diethyleneoxide)EPA 8260B X X
1,4-Dioxane (1,4-
Diethyleneoxide)EPA 8260B SIM X X
1,4-Dioxane (1,4-
Diethyleneoxide)EPA 8260C X X
1,4-Dioxane (1,4-
Diethyleneoxide)EPA 8260C SIM X X
1,4-Dioxane (1,4-
Diethyleneoxide)EPA 8260D X X
1,4-Dioxane (1,4-
Diethyleneoxide)EPA 8260D SIM X X
1,4-Dioxane (1,4-
Diethyleneoxide)EPA 8270C X
1,4-Dioxane (1,4-
Diethyleneoxide)EPA 8270C SIM X
1,4-Dioxane (1,4-
Diethyleneoxide)EPA 8270D X
1,4-Dioxane (1,4-
Diethyleneoxide)EPA 8270D SIM X
1,4-Dioxane (1,4-
Diethyleneoxide)EPA 8270E X
1,4-Dioxane (1,4-
Diethyleneoxide)EPA TO-15 X
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1,4-Dioxane (1,4-
Diethyleneoxide)SM 6200 B-2011 X
1,4-Naphthoquinone EPA 625.1 X
1,4-Naphthoquinone EPA 8270C X X
1,4-Naphthoquinone EPA 8270D X X
1,4-Naphthoquinone EPA 8270E X X
1,4-Phenylenediamine EPA 625.1 X
1,4-Phenylenediamine EPA 8270C X X
1,4-Phenylenediamine EPA 8270D X X
1,4-Phenylenediamine EPA 8270E X X
1-Chloronaphthalene EPA 625.1 X
1-Chloronaphthalene EPA 8270C X X
1-Chloronaphthalene EPA 8270D X X
1-Chloronaphthalene EPA 8270E X X
1-Methylnaphthalene EPA 610 (HPLC) X
1-Methylnaphthalene EPA 625.1 SIM X
1-Methylnaphthalene EPA 8260B X X
1-Methylnaphthalene EPA 8260C X X
1-Methylnaphthalene EPA 8260D X
1-Methylnaphthalene EPA 8270C X X
1-Methylnaphthalene EPA 8270C SIM X X
1-Methylnaphthalene EPA 8270D X X
1-Methylnaphthalene EPA 8270D SIM X X
1-Methylnaphthalene EPA 8270E X X
1-Methylnaphthalene EPA 8270E SIM X X
1-Methylnaphthalene EPA 8310 X X
1-Methylnaphthalene SM 6200 B-2011 X
1-Naphthylamine EPA 625.1 X
1-Naphthylamine EPA 8270C X X
1-Naphthylamine EPA 8270D X X
1-Naphthylamine EPA 8270E X X
2,2,4-Trimethylpentane
(Isooctane)EPA 624.1 X
2,2,4-Trimethylpentane
(Isooctane)EPA 8260B X X
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2,2,4-Trimethylpentane
(Isooctane)EPA 8260C X X
2,2,4-Trimethylpentane
(Isooctane)EPA 8260D X X
2,2,4-Trimethylpentane
(Isooctane)EPA TO-15 X
2,2,4-Trimethylpentane
(Isooctane)SM 6200 B-2011 X
2,2-Dichloropropane EPA 524.2 X
2,2-Dichloropropane EPA 624 (extended) X
2,2-Dichloropropane EPA 624.1 X
2,2-Dichloropropane EPA 8260B X X
2,2-Dichloropropane EPA 8260C X X
2,2-Dichloropropane EPA 8260D X X
2,2-Dichloropropane SM 6200 B-2011 X
2,2'-Oxybis(1-chloropropane),
bis(2-Chloro-1-
methylethyl)ether (bis(2-
chloroisopropyl)ether)
EPA 625.1 X
2,2'-Oxybis(1-chloropropane),
bis(2-Chloro-1-
methylethyl)ether (bis(2-
chloroisopropyl)ether)
EPA 8270C X X
2,2'-Oxybis(1-chloropropane),
bis(2-Chloro-1-
methylethyl)ether (bis(2-
chloroisopropyl)ether)
EPA 8270D X X
2,2'-Oxybis(1-chloropropane),
bis(2-Chloro-1-
methylethyl)ether (bis(2-
chloroisopropyl)ether)
EPA 8270E X X
2,3,4,6-Tetrachlorophenol EPA 625.1 X
2,3,4,6-Tetrachlorophenol EPA 8270C X X
2,3,4,6-Tetrachlorophenol EPA 8270D X X
2,3,4,6-Tetrachlorophenol EPA 8270E X X
2,3-Dichloroaniline EPA 625.1 X
2,4,5-T EPA 8151A X X
2,4,5-T SM 6640 B-2001 X
2,4,5-T SM 6640 B-2006 X
2,4,5-Trichlorophenol EPA 625.1 X
2,4,5-Trichlorophenol EPA 8270C X X
2,4,5-Trichlorophenol EPA 8270D X X
2,4,5-Trichlorophenol EPA 8270E X X
2,4,6-Trichlorophenol EPA 625.1 X
2,4,6-Trichlorophenol EPA 8270C X X
2,4,6-Trichlorophenol EPA 8270D X X
2,4,6-Trichlorophenol EPA 8270E X X
2,4,6-Trinitrotoluene (2,4,6-
TNT)EPA 8330 X X
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2,4,6-Trinitrotoluene (2,4,6-
TNT)EPA 8330A X X
2,4,6-Trinitrotoluene (2,4,6-
TNT)EPA 8330B X X
2,4-D EPA 8151A X X
2,4-D SM 6640 B-2001 X
2,4-D SM 6640 B-2006 X
2,4-DB EPA 8151A X X
2,4-Dichlorophenol EPA 625.1 X
2,4-Dichlorophenol EPA 8270C X X
2,4-Dichlorophenol EPA 8270D X X
2,4-Dichlorophenol EPA 8270E X X
2,4-Dimethylphenol EPA 625.1 X
2,4-Dimethylphenol EPA 8270C X X
2,4-Dimethylphenol EPA 8270D X X
2,4-Dimethylphenol EPA 8270E X X
2,4-Dinitrophenol EPA 625.1 X
2,4-Dinitrophenol EPA 8270C X X
2,4-Dinitrophenol EPA 8270D X X
2,4-Dinitrophenol EPA 8270E X X
2,4-Dinitrotoluene (2,4-DNT)EPA 625.1 X
2,4-Dinitrotoluene (2,4-DNT)EPA 8270C X X
2,4-Dinitrotoluene (2,4-DNT)EPA 8270D X X
2,4-Dinitrotoluene (2,4-DNT)EPA 8270E X X
2,4-Dinitrotoluene (2,4-DNT)EPA 8330 X X
2,4-Dinitrotoluene (2,4-DNT)EPA 8330A X X
2,4-Dinitrotoluene (2,4-DNT)EPA 8330B X X
2,6-Dichlorophenol EPA 625.1 X
2,6-Dichlorophenol EPA 8270C X X
2,6-Dichlorophenol EPA 8270D X X
2,6-Dichlorophenol EPA 8270E X X
2,6-Dinitrotoluene (2,6-DNT)EPA 625.1 X
2,6-Dinitrotoluene (2,6-DNT)EPA 8270C X X
2,6-Dinitrotoluene (2,6-DNT)EPA 8270D X X
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2,6-Dinitrotoluene (2,6-DNT)EPA 8270E X X
2,6-Dinitrotoluene (2,6-DNT)EPA 8330 X X
2,6-Dinitrotoluene (2,6-DNT)EPA 8330A X X
2,6-Dinitrotoluene (2,6-DNT)EPA 8330B X X
2,6-Toluenediisocyanate EPA 8270C X
2,6-Toluenediisocyanate EPA 8270D X
2,6-Toluenediisocyanate EPA 8270E X
2-Acetylaminofluorene EPA 625.1 X
2-Acetylaminofluorene EPA 8270C X X
2-Acetylaminofluorene EPA 8270D X X
2-Acetylaminofluorene EPA 8270E X X
2-Amino-4,6-dinitrotoluene (2-
am-dnt)EPA 8330 X X
2-Amino-4,6-dinitrotoluene (2-
am-dnt)EPA 8330A X X
2-Amino-4,6-dinitrotoluene (2-
am-dnt)EPA 8330B X X
2-Butanone (Methyl ethyl
ketone, MEK)EPA 624.1 X
2-Butanone (Methyl ethyl
ketone, MEK)EPA 8260B X X
2-Butanone (Methyl ethyl
ketone, MEK)EPA 8260C X X
2-Butanone (Methyl ethyl
ketone, MEK)EPA 8260D X X
2-Butanone (Methyl ethyl
ketone, MEK)EPA TO-15 X
2-Butanone (Methyl ethyl
ketone, MEK)SM 6200 B-2011 X
2-Chloroethyl vinyl ether EPA 624.1 X
2-Chloroethyl vinyl ether EPA 8260B X X
2-Chloroethyl vinyl ether EPA 8260C X X
2-Chloroethyl vinyl ether EPA 8260D X X
2-Chloroethyl vinyl ether SM 6200 B-2011 X
2-Chloronaphthalene EPA 625.1 X
2-Chloronaphthalene EPA 8270C X X
2-Chloronaphthalene EPA 8270C SIM X
2-Chloronaphthalene EPA 8270D X X
2-Chloronaphthalene EPA 8270D SIM X
2-Chloronaphthalene EPA 8270E X X
2-Chloronaphthalene EPA 8270E SIM X
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2-Chlorophenol EPA 625.1 X
2-Chlorophenol EPA 8270C X X
2-Chlorophenol EPA 8270D X X
2-Chlorophenol EPA 8270E X X
2-Chlorotoluene EPA 524.2 X
2-Chlorotoluene EPA 624 (extended) X
2-Chlorotoluene EPA 624.1 X
2-Chlorotoluene EPA 8260B X X
2-Chlorotoluene EPA 8260C X X
2-Chlorotoluene EPA 8260D X X
2-Chlorotoluene EPA TO-15 X
2-Chlorotoluene SM 6200 B-2011 X
2-Hexanone EPA 524.2 X
2-Hexanone EPA 624.1 X
2-Hexanone EPA 8260B X X
2-Hexanone EPA 8260C X X
2-Hexanone EPA 8260D X X
2-Hexanone EPA TO-15 X
2-Hexanone SM 6200 B-2011 X
2-methyl-2-butanol (tert-Amyl
alcohol)EPA 624.1 X
2-methyl-2-butanol (tert-Amyl
alcohol)EPA 8260B X X
2-methyl-2-butanol (tert-Amyl
alcohol)EPA 8260C X X
2-methyl-2-butanol (tert-Amyl
alcohol)EPA 8260D X X
2-methyl-2-butanol (tert-Amyl
alcohol)SM 6200 B-2011 X
2-Methyl-2-pentanol EPA 8260B X X
2-Methyl-2-pentanol EPA 8260C X X
2-Methyl-2-pentanol EPA 8260D X
2-methyl-2-pentanol (ethyl tert-
butyl alcohol)EPA 8260B X X
2-methyl-2-pentanol (ethyl tert-
butyl alcohol)EPA 8260D X
2-methyl-2-pentanol (ethyl tert-
butyl alcohol)SM 6200 B-2011 X
2-Methyl-4,6-dinitrophenol
(4,6-Dinitro-2-methylphenol)EPA 625.1 X
2-Methyl-4,6-dinitrophenol
(4,6-Dinitro-2-methylphenol)EPA 8270C X X
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2-Methyl-4,6-dinitrophenol
(4,6-Dinitro-2-methylphenol)EPA 8270D X X
2-Methyl-4,6-dinitrophenol
(4,6-Dinitro-2-methylphenol)EPA 8270E X X
2-Methylaniline (o-Toluidine)EPA 625.1 X
2-Methylaniline (o-Toluidine)EPA 8270C X X
2-Methylaniline (o-Toluidine)EPA 8270D X X
2-Methylaniline (o-Toluidine)EPA 8270E X X
2-Methylnaphthalene EPA 610 (HPLC) X
2-Methylnaphthalene EPA 625.1 X
2-Methylnaphthalene EPA 625.1 SIM X
2-Methylnaphthalene EPA 8260B X X
2-Methylnaphthalene EPA 8260C X X
2-Methylnaphthalene EPA 8260D X X
2-Methylnaphthalene EPA 8270C X X
2-Methylnaphthalene EPA 8270C SIM X X
2-Methylnaphthalene EPA 8270D X X
2-Methylnaphthalene EPA 8270D SIM X X
2-Methylnaphthalene EPA 8270E X X
2-Methylnaphthalene EPA 8270E SIM X X
2-Methylnaphthalene EPA 8310 X X
2-Methylnaphthalene EPA TO-15 X
2-Methylnaphthalene MADEP EPH X X
2-Methylnaphthalene SM 6200 B-2011 X
2-Methylphenol (o-Cresol)EPA 625.1 X
2-Methylphenol (o-Cresol)EPA 8270C X X
2-Methylphenol (o-Cresol)EPA 8270D X X
2-Methylphenol (o-Cresol)EPA 8270E X X
2-Naphthylamine EPA 625.1 X
2-Naphthylamine EPA 8270C X X
2-Naphthylamine EPA 8270D X X
2-Naphthylamine EPA 8270E X X
2-Nitroaniline EPA 625.1 X
2-Nitroaniline EPA 8270C X X
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2-Nitroaniline EPA 8270D X X
2-Nitroaniline EPA 8270E X X
2-Nitrodiphenylamine EPA 8270C X X
2-Nitrodiphenylamine EPA 8270D X X
2-Nitrodiphenylamine EPA 8270E X X
2-Nitroguanidine
(Nitroguanidine)
EPA 8330A
(extended) X X
2-Nitroguanidine
(Nitroguanidine)
EPA 8330B
(extended) X X
2-Nitrophenol EPA 625.1 X
2-Nitrophenol EPA 8270C X X
2-Nitrophenol EPA 8270D X X
2-Nitrophenol EPA 8270E X X
2-Nitropropane EPA 624.1 X
2-Nitropropane EPA 8260B X X
2-Nitropropane EPA 8260C X X
2-Nitropropane EPA 8260D X X
2-Nitropropane SM 6200 B-2011 X
2-Nitrotoluene EPA 8330 X X
2-Nitrotoluene EPA 8330A X X
2-Nitrotoluene EPA 8330B X X
2-Picoline (2-Methylpyridine)EPA 625.1 X
2-Picoline (2-Methylpyridine)EPA 8270C X X
2-Picoline (2-Methylpyridine)EPA 8270D X X
2-Picoline (2-Methylpyridine)EPA 8270E X X
2-Sec-butyl-4,6-dinitrophenol
(DNBP, Dinoseb)EPA 8151A X
3,3'-Dichlorobenzidine EPA 625.1 X
3,3'-Dichlorobenzidine EPA 8270C X X
3,3'-Dichlorobenzidine EPA 8270D X X
3,3'-Dichlorobenzidine EPA 8270E X X
3,3-dimethyl-1-butanol EPA 624.1 X
3,3-dimethyl-1-butanol EPA 8260B X X
3,3-dimethyl-1-butanol EPA 8260C X X
3,3-dimethyl-1-butanol EPA 8260D X X
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3,3-dimethyl-1-butanol SM 6200 B-2011 X
3,3'-Dimethylbenzidine EPA 625.1 X
3,3'-Dimethylbenzidine EPA 8270C X X
3,3'-Dimethylbenzidine EPA 8270D X X
3,3'-Dimethylbenzidine EPA 8270E X X
3+4 Methylphenol EPA 625.1 X
3+4 Methylphenol EPA 8270C X X
3+4 Methylphenol EPA 8270D X X
3+4 Methylphenol EPA 8270E X
3-Methylcholanthrene EPA 625.1 X
3-Methylcholanthrene EPA 8270C X X
3-Methylcholanthrene EPA 8270D X X
3-Methylcholanthrene EPA 8270E X X
3-Methylphenol (m-Cresol)EPA 625.1 X
3-Nitroaniline EPA 625.1 X
3-Nitroaniline EPA 8270C X X
3-Nitroaniline EPA 8270D X X
3-Nitroaniline EPA 8270E X X
3-Nitrotoluene EPA 8330 X X
3-Nitrotoluene EPA 8330A X X
3-Nitrotoluene EPA 8330B X X
4,4'-DDD EPA 608.3 X
4,4'-DDD EPA 8081A X X
4,4'-DDD EPA 8081B X X
4,4'-DDE EPA 608.3 X
4,4'-DDE EPA 8081A X X
4,4'-DDE EPA 8081B X X
4,4'-DDT EPA 608.3 X
4,4'-DDT EPA 8081A X X
4,4'-DDT EPA 8081B X X
4,4'-Methylenebis(2-
chloroaniline)EPA 8270C X X
4,4'-Methylenebis(2-
chloroaniline)EPA 8270D X X
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4,4'-Methylenebis(2-
chloroaniline)EPA 8270E X
4-Amino-2,6-dinitrotoluene (4-
am-dnt)EPA 8330 X X
4-Amino-2,6-dinitrotoluene (4-
am-dnt)EPA 8330A X X
4-Amino-2,6-dinitrotoluene (4-
am-dnt)EPA 8330B X X
4-Aminobiphenyl EPA 625.1 X
4-Aminobiphenyl EPA 8270C X X
4-Aminobiphenyl EPA 8270D X X
4-Aminobiphenyl EPA 8270E X X
4-Bromophenyl phenyl ether EPA 625.1 X
4-Bromophenyl phenyl ether EPA 625.1 SIM X
4-Bromophenyl phenyl ether EPA 8270C X X
4-Bromophenyl phenyl ether EPA 8270D X X
4-Bromophenyl phenyl ether EPA 8270E X X
4-Chloro-3-methylphenol EPA 625.1 X
4-Chloro-3-methylphenol EPA 8270C X X
4-Chloro-3-methylphenol EPA 8270D X X
4-Chloro-3-methylphenol EPA 8270E X X
4-Chloroaniline EPA 625.1 X
4-Chloroaniline EPA 8270C X X
4-Chloroaniline EPA 8270D X X
4-Chloroaniline EPA 8270E X X
4-Chlorophenyl phenylether EPA 625.1 X
4-Chlorophenyl phenylether EPA 8270C X X
4-Chlorophenyl phenylether EPA 8270D X X
4-Chlorophenyl phenylether EPA 8270E X X
4-Chlorotoluene EPA 524.2 X
4-Chlorotoluene EPA 624 (extended) X
4-Chlorotoluene EPA 624.1 X
4-Chlorotoluene EPA 8260B X X
4-Chlorotoluene EPA 8260C X X
4-Chlorotoluene EPA 8260D X X
4-Chlorotoluene SM 6200 B-2011 X
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4-Dimethyl aminoazobenzene EPA 8270C X
4-Dimethyl aminoazobenzene EPA 8270D X
4-Dimethyl aminoazobenzene EPA 8270E X
4-Ethyltoluene EPA 8260B X
4-Ethyltoluene EPA TO-15 X
4-Isopropyltoluene EPA 524.2 X
4-Isopropyltoluene (p-Cymene)EPA 624 (extended) X
4-Isopropyltoluene (p-Cymene)EPA 624.1 X
4-Isopropyltoluene (p-Cymene)EPA 8260B X X
4-Isopropyltoluene (p-Cymene)EPA 8260C X X
4-Isopropyltoluene (p-Cymene)EPA 8260D X X
4-Isopropyltoluene (p-Cymene)SM 6200 B-2011 X
4-Methyl-2-pentanone (MIBK)EPA 624.1 X
4-Methyl-2-pentanone (MIBK)EPA 8260B X X
4-Methyl-2-pentanone (MIBK)EPA 8260C X X
4-Methyl-2-pentanone (MIBK)EPA 8260D X X
4-Methyl-2-pentanone (MIBK)EPA TO-15 X
4-Methyl-2-pentanone (MIBK)SM 6200 B-2011 X
4-Methylphenol (p-Cresol)EPA 625.1 X
4-Methylphenol (p-Cresol)EPA 8270C X X
4-Methylphenol (p-Cresol)EPA 8270D X X
4-Methylphenol (p-Cresol)EPA 8270E X X
4-Nitroaniline EPA 625.1 X
4-Nitroaniline EPA 8270C X X
4-Nitroaniline EPA 8270D X X
4-Nitroaniline EPA 8270E X X
4-Nitrophenol EPA 625.1 X
4-Nitrophenol EPA 8270C X X
4-Nitrophenol EPA 8270D X X
4-Nitrophenol EPA 8270E X X
4-Nitroquinoline 1-oxide EPA 625.1 X
4-Nitroquinoline 1-oxide EPA 8270C X X
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4-Nitroquinoline 1-oxide EPA 8270D X X
4-Nitroquinoline 1-oxide EPA 8270E X X
4-Nitrotoluene EPA 8330 X X
4-Nitrotoluene EPA 8330A X X
4-Nitrotoluene EPA 8330B X X
5-Nitro-o-toluidine EPA 625.1 X
5-Nitro-o-toluidine EPA 8270C X X
5-Nitro-o-toluidine EPA 8270D X X
5-Nitro-o-toluidine EPA 8270E X X
7,12-Dimethylbenz(a)
anthracene EPA 625.1 X
7,12-Dimethylbenz(a)
anthracene EPA 8270C X X
7,12-Dimethylbenz(a)
anthracene EPA 8270D X X
7,12-Dimethylbenz(a)
anthracene EPA 8270E X X
7h-Dibenzo(c,g) carbazole EPA 8270C X X
7h-Dibenzo(c,g) carbazole EPA 8270D X X
7h-Dibenzo(c,g) carbazole EPA 8270E X X
96-hour LC50 EPA 2000 X
a-a-Dimethylphenethylamine EPA 625.1 X
a-a-Dimethylphenethylamine EPA 8270C X X
a-a-Dimethylphenethylamine EPA 8270D X X
a-a-Dimethylphenethylamine EPA 8270E X X
Acenaphthene EPA 610 (HPLC) X
Acenaphthene EPA 625.1 X
Acenaphthene EPA 625.1 SIM X
Acenaphthene EPA 8270C X X
Acenaphthene EPA 8270C SIM X X
Acenaphthene EPA 8270D X X
Acenaphthene EPA 8270D SIM X X
Acenaphthene EPA 8270E X X
Acenaphthene EPA 8270E SIM X X
Acenaphthene EPA 8310 X X
Acenaphthene MADEP EPH X X
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Acenaphthylene EPA 610 (HPLC) X
Acenaphthylene EPA 625.1 X
Acenaphthylene EPA 625.1 SIM X
Acenaphthylene EPA 8270C X X
Acenaphthylene EPA 8270C SIM X X
Acenaphthylene EPA 8270D X X
Acenaphthylene EPA 8270D SIM X X
Acenaphthylene EPA 8270E X X
Acenaphthylene EPA 8270E SIM X X
Acenaphthylene EPA 8310 X X
Acenaphthylene MADEP EPH X X
Acetaldehyde EPA TO-15 X
Acetone EPA 624.1 X
Acetone EPA 8260B X X
Acetone EPA 8260C X X
Acetone EPA 8260D X X
Acetone EPA TO-15 X
Acetone SM 6200 B-2011 X
Acetone EPA 524.2 X
Acetonitrile EPA 624.1 X
Acetonitrile EPA 8260B X X
Acetonitrile EPA 8260C X X
Acetonitrile EPA 8260D X X
Acetonitrile EPA TO-15 X
Acetonitrile SM 6200 B-2011 X
Acetophenone EPA 625.1 X
Acetophenone EPA 8270C X X
Acetophenone EPA 8270D X X
Acetophenone EPA 8270E X X
Acetylene
EPA RSK-175
(GC/FID)X X
Acid Digestion of Aqueous
samples and Extracts for Total
Metals (HNO3 + HCl)
EPA 3010A X
Acid Digestion of Oils for
Metals Analysis or ICP
Spectrometry
EPA 3031 X
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Acid Digestion of Sediments,
Sludges, and soils EPA 3050B X
Acid Digestion of waters for
Total Recoverable or Dissolved
Metals
EPA 3005A X
Acidity, as CaCO3 SM 2310 B-2011 X
Acrolein (Propenal)EPA 624.1 X
Acrolein (Propenal)EPA 8260B X X
Acrolein (Propenal)EPA 8260C X X
Acrolein (Propenal)EPA 8260D X X
Acrolein (Propenal)EPA TO-15 X
Acrolein (Propenal)SM 6200 B-2011 X
Acrylonitrile EPA 624.1 X
Acrylonitrile EPA 8260B X X
Acrylonitrile EPA 8260C X X
Acrylonitrile EPA 8260D X X
Acrylonitrile EPA TO-15 X
Acrylonitrile SM 6200 B-2011 X
Acute toxicity
EPA 2002
Ceriodaphnia dubia
Acute MHSF 25ºC
X
Alachlor EPA 507 X X
Aldrin EPA 608.3 X
Aldrin EPA 8081A X X
Aldrin EPA 8081B X X
Alkalinity as CaCO3 EPA 310.2 X
Alkalinity as CaCO3 SM 2320 B-2011 X X
Allyl chloride (3-
Chloropropene)EPA 624.1 X
Allyl chloride (3-
Chloropropene)EPA 8260B X X
Allyl chloride (3-
Chloropropene)EPA 8260C X X
Allyl chloride (3-
Chloropropene)EPA 8260D X X
Allyl chloride (3-
Chloropropene)EPA TO-15 X
Allyl chloride (3-
Chloropropene)SM 6200 B-2011 X
Alpha Emitting Radium
Isotopes EPA 9315 X X
alpha-BHC (alpha-
Hexachlorocyclohexane)EPA 608.3 X
alpha-BHC (alpha-
Hexachlorocyclohexane)EPA 8081A X X
alpha-BHC (alpha-
Hexachlorocyclohexane)EPA 8081B X X
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alpha-Chlordane EPA 608.3 X
alpha-Chlordane EPA 8081A X X
alpha-Chlordane EPA 8081B X X
alpha-Terpineol EPA 625.1 X
alpha-Terpineol EPA 8270C X X
alpha-Terpineol EPA 8270D X X
alpha-Terpineol EPA 8270E X
Alumina Clean-Up EPA 3610B X
Alumina Clean-Up EPA 3611B X
Aluminum EPA 200.7 X X
Aluminum EPA 200.8 X X
Aluminum EPA 6010B X X
Aluminum EPA 6010C X X
Aluminum EPA 6010D X X
Aluminum EPA 6020 X X
Aluminum EPA 6020A X X
Aluminum EPA 6020B X X
Amenable cyanide EPA 9010B X
Amenable cyanide EPA 9010C X X
Amenable cyanide EPA 9012B X X
Amenable cyanide EPA 9014 X X
Amenable cyanide
SM 4500-CN¯ B-
2011 X
Amenable cyanide
SM 4500-CN¯ G-
2011 X
Americium-241
EPA 907 Modified
(ENV-SOP-MTJL-
0332)
X X X X
Ammonia
SM 4500-NH3 B-
2011 X
Ammonia as N EPA 350.1 X X X
Ammonia as N
SM 4500-NH3 B-
2011 X
Ammonia as N
SM 4500-NH3 G-
2011 X
Aniline EPA 625.1 X
Aniline EPA 8270C X X
Aniline EPA 8270D X X
Aniline EPA 8270E X X
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Anthracene EPA 610 (HPLC) X
Anthracene EPA 625.1 X
Anthracene EPA 625.1 SIM X
Anthracene EPA 8270C X X
Anthracene EPA 8270C SIM X X
Anthracene EPA 8270D X X
Anthracene EPA 8270D SIM X X
Anthracene EPA 8270E X X
Anthracene EPA 8270E SIM X X
Anthracene EPA 8310 X X
Anthracene MADEP EPH X X
Antimony EPA 200.7 X X
Antimony EPA 200.8 X X
Antimony EPA 6010B X X
Antimony EPA 6010C X X
Antimony EPA 6010D X X
Antimony EPA 6020 X X
Antimony EPA 6020A X X
Antimony EPA 6020B X X
Aramite EPA 625.1 X
Aramite EPA 8270C X X
Aramite EPA 8270D X X
Aramite EPA 8270E X X
Aroclor-1016 (PCB-1016)EPA 600/4-81-045 X
Aroclor-1016 (PCB-1016)EPA 608.3 X
Aroclor-1016 (PCB-1016)EPA 8082 X X
Aroclor-1016 (PCB-1016)EPA 8082A X X
Aroclor-1016 (PCB-1016) in
Oil EPA 8082A X
Aroclor-1221 (PCB-1221)EPA 600/4-81-045 X
Aroclor-1221 (PCB-1221)EPA 608.3 X
Aroclor-1221 (PCB-1221)EPA 8082 X X
Aroclor-1221 (PCB-1221)EPA 8082A X X
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Aroclor-1221 (PCB-1221) in
Oil EPA 8082A X
Aroclor-1232 (PCB-1232)EPA 600/4-81-045 X
Aroclor-1232 (PCB-1232)EPA 608.3 X
Aroclor-1232 (PCB-1232)EPA 8082 X X
Aroclor-1232 (PCB-1232)EPA 8082A X X
Aroclor-1232 (PCB-1232) in
Oil EPA 8082A X
Aroclor-1242 (PCB-1242)EPA 600/4-81-045 X
Aroclor-1242 (PCB-1242)EPA 608.3 X
Aroclor-1242 (PCB-1242)EPA 8082 X X
Aroclor-1242 (PCB-1242)EPA 8082A X X
Aroclor-1242 (PCB-1242) in
Oil EPA 8082A X
Aroclor-1248 (PCB-1248)EPA 600/4-81-045 X
Aroclor-1248 (PCB-1248)EPA 608.3 X
Aroclor-1248 (PCB-1248)EPA 8082 X X
Aroclor-1248 (PCB-1248)EPA 8082A X X
Aroclor-1248 (PCB-1248) in
Oil EPA 8082A X
Aroclor-1254 (PCB-1254)EPA 600/4-81-045 X
Aroclor-1254 (PCB-1254)EPA 608.3 X
Aroclor-1254 (PCB-1254)EPA 8082 X X
Aroclor-1254 (PCB-1254)EPA 8082A X X
Aroclor-1254 (PCB-1254) in
Oil EPA 8082A X
Aroclor-1260 (PCB-1260)EPA 600/4-81-045 X
Aroclor-1260 (PCB-1260)EPA 608.3 X
Aroclor-1260 (PCB-1260)EPA 8082 X X
Aroclor-1260 (PCB-1260)EPA 8082A X X
Aroclor-1260 (PCB-1260) in
Oil EPA 8082A X
Aroclor-1262 (PCB-1262)EPA 600/4-81-045 X
Aroclor-1262 (PCB-1262)EPA 8082 X X
Aroclor-1262 (PCB-1262)EPA 8082A X X
Aroclor-1262 (PCB-1262) in
Oil EPA 8082A X
Aroclor-1268 (PCB-1268)EPA 600/4-81-045 X
Aroclor-1268 (PCB-1268)EPA 8082 X X
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Aroclor-1268 (PCB-1268)EPA 8082A X X
Aroclor-1268 (PCB-1268) in
Oil EPA 8082A X
Arsenic EPA 200.7 X X
Arsenic EPA 200.8 X X
Arsenic EPA 6010B X X
Arsenic EPA 6010C X X
Arsenic EPA 6010D X X
Arsenic EPA 6020 X X
Arsenic EPA 6020A X X
Arsenic EPA 6020B X X
Atrazine EPA 507 X X
Atrazine EPA 625.1 X
Atrazine EPA 8141A X
Atrazine EPA 8141B X
Atrazine EPA 8270C X X
Atrazine EPA 8270D X X
Atrazine EPA 8270E X X
Azinphos-methyl (Guthion)EPA 1657 X
Azinphos-methyl (Guthion)EPA 8141A X X
Azinphos-methyl (Guthion)EPA 8141B X X
Barium EPA 200.7 X X
Barium EPA 200.8 X X
Barium EPA 6010B X X
Barium EPA 6010C X X
Barium EPA 6010D X X
Barium EPA 6020 X X
Barium EPA 6020A X X
Barium EPA 6020B X X
Barium-133 DOE 4.5.2.3 X
Barium-133 EPA 901.1 X
Barium-133 HASL 300 Ga-01-R X
Benzal chloride EPA 8270C X X
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Benzal chloride EPA 8270D X X
Benzal chloride EPA 8270E X X
Benzaldehyde EPA 625.1 X
Benzaldehyde EPA 8270C X X
Benzaldehyde EPA 8270D X X
Benzaldehyde EPA 8270E X X
Benzene EPA 602 X
Benzene EPA 624.1 X
Benzene EPA 8021B X X
Benzene EPA 8260B X X
Benzene EPA 8260C X X
Benzene EPA 8260D X X
Benzene EPA TO-15 X
Benzene
EPA TO-15 GC/MS
SIM X
Benzene IDNR OA-1 X X
Benzene LUFT GCMS X X
Benzene MADEP VPH X X
Benzene OK DEQ GRO X X
Benzene SM 6200 B-2011 X
Benzene EPA 524.2 X
Benzenethiol EPA 625.1 X
Benzenethiol EPA 8270C X X
Benzenethiol EPA 8270D X X
Benzenethiol EPA 8270E X
Benzidine EPA 625.1 X
Benzidine EPA 8270C X X
Benzidine EPA 8270D X X
Benzidine EPA 8270E X X
Benzo(a)anthracene EPA 610 (HPLC) X
Benzo(a)anthracene EPA 625.1 X
Benzo(a)anthracene EPA 625.1 SIM X
Benzo(a)anthracene EPA 8270C X X
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Benzo(a)anthracene EPA 8270C SIM X X
Benzo(a)anthracene EPA 8270D X X
Benzo(a)anthracene EPA 8270D SIM X X
Benzo(a)anthracene EPA 8270E X X
Benzo(a)anthracene EPA 8270E SIM X X
Benzo(a)anthracene EPA 8310 X X
Benzo(a)anthracene MADEP EPH X X
Benzo(a)pyrene EPA 610 (HPLC) X
Benzo(a)pyrene EPA 625.1 X
Benzo(a)pyrene EPA 625.1 SIM X
Benzo(a)pyrene EPA 8270C X X
Benzo(a)pyrene EPA 8270C SIM X X
Benzo(a)pyrene EPA 8270D X X
Benzo(a)pyrene EPA 8270D SIM X X
Benzo(a)pyrene EPA 8270E X X
Benzo(a)pyrene EPA 8270E SIM X X
Benzo(a)pyrene EPA 8310 X X
Benzo(a)pyrene MADEP EPH X X
Benzo(b)fluoranthene EPA 610 (HPLC) X
Benzo(b)fluoranthene EPA 625.1 X
Benzo(b)fluoranthene EPA 625.1 SIM X
Benzo(b)fluoranthene EPA 8270C X X
Benzo(b)fluoranthene EPA 8270C SIM X X
Benzo(b)fluoranthene EPA 8270D X X
Benzo(b)fluoranthene EPA 8270D SIM X X
Benzo(b)fluoranthene EPA 8270E X X
Benzo(b)fluoranthene EPA 8270E SIM X X
Benzo(b)fluoranthene EPA 8310 X X
Benzo(b)fluoranthene MADEP EPH X X
Benzo(e)pyrene EPA 8270D SIM X X
Benzo(e)pyrene EPA 8270E SIM X X
Benzo(g,h,i)perylene EPA 610 (HPLC) X
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Benzo(g,h,i)perylene EPA 625.1 X
Benzo(g,h,i)perylene EPA 625.1 SIM X
Benzo(g,h,i)perylene EPA 8270C X X
Benzo(g,h,i)perylene EPA 8270C SIM X X
Benzo(g,h,i)perylene EPA 8270D X X
Benzo(g,h,i)perylene EPA 8270D SIM X X
Benzo(g,h,i)perylene EPA 8270E X X
Benzo(g,h,i)perylene EPA 8270E SIM X X
Benzo(g,h,i)perylene EPA 8310 X X
Benzo(g,h,i)perylene MADEP EPH X X
Benzo(j)fluoranthene EPA 8270C X X
Benzo(j)fluoranthene EPA 8270D X X
Benzo(j)fluoranthene EPA 8270E X X
Benzo(k)fluoranthene EPA 610 (HPLC) X
Benzo(k)fluoranthene EPA 625.1 X
Benzo(k)fluoranthene EPA 625.1 SIM X
Benzo(k)fluoranthene EPA 8270C X X
Benzo(k)fluoranthene EPA 8270C SIM X X
Benzo(k)fluoranthene EPA 8270D X X
Benzo(k)fluoranthene EPA 8270D SIM X X
Benzo(k)fluoranthene EPA 8270E X X
Benzo(k)fluoranthene EPA 8270E SIM X X
Benzo(k)fluoranthene EPA 8310 X X
Benzo(k)fluoranthene MADEP EPH X X
Benzoic acid EPA 625.1 X
Benzoic acid EPA 8270C X X
Benzoic acid EPA 8270D X X
Benzoic acid EPA 8270E X X
Benzotrichloride EPA 8270C X X
Benzotrichloride EPA 8270D X X
Benzotrichloride EPA 8270E X X
Benzyl alcohol EPA 625.1 X
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Benzyl alcohol EPA 8270C X X
Benzyl alcohol EPA 8270D X X
Benzyl alcohol EPA 8270E X X
Benzyl chloride EPA 8270C X X
Benzyl chloride EPA 8270D X X
Benzyl chloride EPA 8270E X X
Benzyl chloride EPA TO-15 X
Beryllium EPA 200.7 X X
Beryllium EPA 200.8 X X
Beryllium EPA 6010B X X
Beryllium EPA 6010C X X
Beryllium EPA 6010D X X
Beryllium EPA 6020 X X
Beryllium EPA 6020A X X
Beryllium EPA 6020B X X
beta-BHC (beta-
Hexachlorocyclohexane)EPA 608.3 X
beta-BHC (beta-
Hexachlorocyclohexane)EPA 8081A X X
beta-BHC (beta-
Hexachlorocyclohexane)EPA 8081B X X
Biochemical oxygen demand SM 5210 B-2011 X
Biphenyl (1,1'-Biphenyl)EPA 625.1 X
Biphenyl (1,1'-Biphenyl)EPA 8270C X X
Biphenyl (1,1'-Biphenyl)EPA 8270D X X
Biphenyl (1,1'-Biphenyl)EPA 8270E X X
bis(2-Chloroethoxy)methane EPA 625.1 X
bis(2-Chloroethoxy)methane EPA 8270C X X
bis(2-Chloroethoxy)methane EPA 8270D X X
bis(2-Chloroethoxy)methane EPA 8270E X X
bis(2-Chloroethyl) ether EPA 625.1 X
bis(2-Chloroethyl) ether EPA 8270C X X
bis(2-Chloroethyl) ether EPA 8270D X X
bis(2-Chloroethyl) ether EPA 8270E X X
Bis(2-Chloroisopropyl) ether EPA 625.1 X
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Bis(2-Chloroisopropyl) ether EPA 8270E X X
Bis(2-Chloroisopropyl) ether
(2,2-oxybis(1-chloropropane))EPA 8270C X X
Bis(2-Chloroisopropyl) ether
(2,2-oxybis(1-chloropropane))EPA 8270D X X
bis(2-Ethylhexyl)adipate EPA 625.1 X
bis(2-Ethylhexyl)adipate EPA 625.1 SIM X
Bolstar (Sulprofos)EPA 1657 X
Bolstar (Sulprofos)EPA 8141A X X
Bolstar (Sulprofos)EPA 8141B X X
Boron EPA 200.7 X X
Boron EPA 200.8 X
Boron EPA 6010B X X
Boron EPA 6010C X X
Boron EPA 6010D X X
Boron EPA 6020 X X
Boron EPA 6020A X X
Boron EPA 6020B X X
Bromide EPA 300.0 X X X
Bromide EPA 9056 X X
Bromide EPA 9056A X X
Bromide SM 4110 B-2011 X X
Bromoacetic acid EPA 552.2 X
Bromobenzene EPA 524.2 X
Bromobenzene EPA 624 (extended) X
Bromobenzene EPA 624.1 X
Bromobenzene EPA 8260B X X
Bromobenzene EPA 8260C X X
Bromobenzene EPA 8260D X X
Bromobenzene SM 6200 B-2011 X
Bromochloromethane EPA 524.2 X
Bromochloromethane EPA 624.1 X
Bromochloromethane EPA 8260B X X
Bromochloromethane EPA 8260C X X
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Bromochloromethane EPA 8260D X X
Bromochloromethane SM 6200 B-2011 X
Bromodichloromethane EPA 624.1 X
Bromodichloromethane EPA 8260B X X
Bromodichloromethane EPA 8260C X X
Bromodichloromethane EPA 8260D X X
Bromodichloromethane EPA TO-15 X
Bromodichloromethane SM 6200 B-2011 X
Bromoethane (Ethyl Bromide)EPA 624.1 X
Bromoethane (Ethyl Bromide)EPA TO-15 X
Bromoform EPA 624.1 X
Bromoform EPA 8260B X X
Bromoform EPA 8260C X X
Bromoform EPA 8260D X X
Bromoform EPA TO-15 X
Bromoform SM 6200 B-2011 X
Bromoform EPA 524.2 X
Butachlor EPA 507 X X
Butyl benzyl phthalate EPA 625.1 X
Butyl benzyl phthalate EPA 8270C X X
Butyl benzyl phthalate EPA 8270D X X
Butyl benzyl phthalate EPA 8270E X X
Cadmium EPA 200.7 X X
Cadmium EPA 200.8 X X
Cadmium EPA 6010B X X
Cadmium EPA 6010C X X
Cadmium EPA 6010D X X
Cadmium EPA 6020 X X
Cadmium EPA 6020A X X
Cadmium EPA 6020B X X
Calcium EPA 200.7 X X
Calcium EPA 200.8 X
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Calcium EPA 6010B X X
Calcium EPA 6010C X X
Calcium EPA 6010D X X
Calcium EPA 6020 X X
Calcium EPA 6020A X X
Calcium EPA 6020B X X
Calcium hardness as CaCO3 EPA 200.7 X
Calcium hardness as CaCO3 EPA 200.8 X
Calcium hardness as CaCO3 EPA 6010B X
Calcium hardness as CaCO3 EPA 6010C X X
Calcium hardness as CaCO3 EPA 6010D X
Calcium hardness as CaCO3 SM 2340 B-2011 X
California Waste Extraction
Test
CCR Chapter 11,
Article 5 Appendix II X
Caprolactam EPA 625.1 X
Caprolactam EPA 8270C X X
Caprolactam EPA 8270D X X
Caprolactam EPA 8270E X X
Carbazole EPA 625.1 X
Carbazole EPA 8270C X X
Carbazole EPA 8270D X X
Carbazole EPA 8270E X X
Carbon dioxide ASTM D1946-90 X
Carbon dioxide
SM 4500-CO2 D-
2011 X X
Carbon disulfide EPA 624.1 X
Carbon disulfide EPA 8260B X X
Carbon disulfide EPA 8260C X X
Carbon disulfide EPA 8260D X X
Carbon disulfide EPA TO-15 X
Carbon disulfide SM 6200 B-2011 X
Carbon disulfide EPA 524.2 X
Carbon monoxide ASTM D1946-90 X
Carbon tetrachloride EPA 624.1 X
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Carbon tetrachloride EPA 8260B X X
Carbon tetrachloride EPA 8260C X X
Carbon tetrachloride EPA 8260D X X
Carbon tetrachloride EPA TO-15 X
Carbon tetrachloride
EPA TO-15 GC/MS
SIM X
Carbon tetrachloride SM 6200 B-2011 X
Carbon tetrachloride EPA 524.2 X
Carbon-14
EPA EERF Method
C-01 X X X X
Carbonaceous BOD, CBOD SM 5210 B-2011 X
Carbophenothion EPA 8141A X
Carbophenothion EPA 8141B X
Ceriodaphnia dubia EPA 1002 X
Ceriodaphnia dubia
EPA 2002
Ceriodaphnia dubia
Acute MHSF 25ºC
X
Ceriodaphnia dubia EPA 2002.0 X
Cesium-134 DOE 4.5.2.3 X
Cesium-134 EPA 901.1 X X
Cesium-134 HASL 300 Ga-01-R X
Cesium-137 DOE 4.5.2.3 X
Cesium-137 EPA 901.1 X X
Cesium-137 HASL 300 Ga-01-R X
Chemical oxygen demand EPA 410.4 X
Chemical oxygen demand SM 5220 D-2011 X
Chlorate EPA 300.0 X
Chlordane (tech.)EPA 608.3 X
Chlordane (tech.)EPA 8081A X X
Chlordane (tech.)EPA 8081B X X
Chloride EPA 300.0 X X X
Chloride EPA 9056 X X
Chloride EPA 9056A X X
Chloride SM 4110 B-2011 X X
Chlorine EPA 9076 X
Chlorine SM 4500-Cl G-2011 X X
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Chloroacetic acid EPA 552.2 X
Chlorobenzene EPA 624.1 X
Chlorobenzene EPA 8260B X X
Chlorobenzene EPA 8260C X X
Chlorobenzene EPA 8260D X X
Chlorobenzene EPA TO-15 X
Chlorobenzene SM 6200 B-2011 X
Chlorobenzene EPA 524.2 X
Chlorobenzilate EPA 625.1 X
Chlorobenzilate EPA 8270C X X
Chlorobenzilate EPA 8270D X X
Chlorobenzilate EPA 8270E X X
Chlorodibromomethane EPA 524.2 X
Chlorodibromomethane
(dibromochloromethane)EPA 624.1 X
Chlorodibromomethane
(dibromochloromethane)EPA 8260B X X
Chlorodibromomethane
(dibromochloromethane)EPA 8260C X X
Chlorodibromomethane
(dibromochloromethane)EPA 8260D X X
Chlorodibromomethane
(dibromochloromethane)EPA TO-15 X
Chlorodibromomethane
(dibromochloromethane)SM 6200 B-2011 X
Chloroethane EPA 524.2 X
Chloroethane (Ethyl chloride)EPA 624.1 X
Chloroethane (Ethyl chloride)EPA 8260B X X
Chloroethane (Ethyl chloride)EPA 8260C X X
Chloroethane (Ethyl chloride)EPA 8260D X X
Chloroethane (Ethyl chloride)EPA TO-15 X
Chloroethane (Ethyl chloride)
EPA TO-15 GC/MS
SIM X
Chloroethane (Ethyl chloride)SM 6200 B-2011 X
Chloroform EPA 624.1 X
Chloroform EPA 8260B X X
Chloroform EPA 8260C X X
Chloroform EPA 8260D X X
Chloroform EPA TO-15 X
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Chloroform
EPA TO-15 GC/MS
SIM X
Chloroform SM 6200 B-2011 X
Chloroform EPA 524.2 X
Chloromethane EPA 524.2 X
Chloroprene (2-Chloro-1,3-
butadiene)EPA 624.1 X
Chloroprene (2-Chloro-1,3-
butadiene)EPA 8260B X X
Chloroprene (2-Chloro-1,3-
butadiene)EPA 8260C X X
Chloroprene (2-Chloro-1,3-
butadiene)EPA 8260D X X
Chloroprene (2-Chloro-1,3-
butadiene)SM 6200 B-2011 X
Chlorpyrifos EPA 1657 X
Chlorpyrifos EPA 8141A X X
Chlorpyrifos EPA 8141B X X
Chromium EPA 200.7 X X
Chromium EPA 200.8 X X
Chromium EPA 6010B X X
Chromium EPA 6010C X X
Chromium EPA 6010D X X
Chromium EPA 6020 X X
Chromium EPA 6020A X X
Chromium EPA 6020B X X
Chromium VI EPA 218.6 X X
Chromium VI EPA 3060A X
Chromium VI EPA 7196A X X
Chromium VI EPA 7199 X X
Chromium VI SM 3500-Cr B-2011 X X
Chromium VI SM 3500-Cr C-2011 X X
Chromium VI Digestion EPA 3060A X
Chrysene EPA 610 (HPLC) X
Chrysene EPA 625.1 X
Chrysene EPA 625.1 SIM X
Chrysene EPA 8270C X X
Chrysene EPA 8270C SIM X X
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Chrysene EPA 8270D X X
Chrysene EPA 8270D SIM X X
Chrysene EPA 8270E X X
Chrysene EPA 8270E SIM X X
Chrysene EPA 8310 X X
Chrysene MADEP EPH X X
cis-1,2-Dichloroethene EPA 524.2 X
cis-1,2-Dichloroethylene EPA 624.1 X
cis-1,2-Dichloroethylene EPA 8260B X X
cis-1,2-Dichloroethylene EPA 8260C X X
cis-1,2-Dichloroethylene EPA 8260D X X
cis-1,2-Dichloroethylene EPA TO-15 X
cis-1,2-Dichloroethylene
EPA TO-15 GC/MS
SIM X
cis-1,2-Dichloroethylene SM 6200 B-2011 X
cis-1,3-Dichloropropene EPA 524.2 X
cis-1,3-Dichloropropene EPA 624.1 X
cis-1,3-Dichloropropene EPA 8260B X X
cis-1,3-Dichloropropene EPA 8260C X X
cis-1,3-Dichloropropene EPA 8260D X X
cis-1,3-Dichloropropene EPA TO-15 X
cis-1,3-Dichloropropene
EPA TO-15 GC/MS
SIM X
cis-1,3-Dichloropropene SM 6200 B-2011 X
cis-1,4-Dichloro-2-butene EPA 624.1 X
cis-1,4-Dichloro-2-butene EPA 8260B X X
cis-1,4-Dichloro-2-butene EPA 8260C X X
cis-1,4-Dichloro-2-butene EPA 8260D X X
cis-1,4-Dichloro-2-butene SM 6200 B-2011 X
cis-Diallate EPA 8270C X
cis-Isosafrole EPA 8270C X
Closed-System Purge-and-Trap
and Extraction for Volatile
Organics in Soil and Waste
Samples
EPA 5035A X
Cobalt EPA 200.7 X X
Cobalt EPA 200.8 X
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Cobalt EPA 6010B X X
Cobalt EPA 6010C X X
Cobalt EPA 6010D X X
Cobalt EPA 6020 X X
Cobalt EPA 6020A X X
Cobalt EPA 6020B X X
Cobalt-60 DOE 4.5.2.3 X
Cobalt-60 EPA 901.1 X X
Cobalt-60 HASL 300 Ga-01-R X
Color SM 2120 B-2011 X X
Conductivity EPA 120.1 X X
Conductivity EPA 9050A X X
Conductivity SM 2510 B-2011 X X
Copper EPA 200.7 X X
Copper EPA 200.8 X X
Copper EPA 6010B X X
Copper EPA 6010C X X
Copper EPA 6010D X X
Copper EPA 6020 X X
Copper EPA 6020A X X
Copper EPA 6020B X X
Corrosivity (langlier index)SM 2320 B-2011 X X
Corrosivity (pH)EPA 9040B X
Corrosivity (pH)EPA 9040C X
Corrosivity (pH)EPA 9045D X
Coumaphos EPA 1657 X
Coumaphos EPA 8141A X X
Coumaphos EPA 8141B X X
Cyanazine EPA 8141A X X
Cyanazine EPA 8141B X X
Cyanide EPA 335.4 X X
Cyanide EPA 9010B X X
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Cyanide EPA 9010C X X
Cyanide EPA 9012A X
Cyanide EPA 9012B X X
Cyanide EPA 9013 X
Cyanide EPA 9013A X
Cyanide EPA 9014 X X
Cyanide
SM 4500-CN¯ B-
2011 X X
Cyanide
SM 4500-CN¯ C-
2011 X X
Cyanide
SM 4500-CN¯ E-
2011 X X
Cyanide
SM 4500-CN¯ G-
2011 X
Cyclohexane EPA 624.1 X
Cyclohexane EPA 8260B X X
Cyclohexane EPA 8260C X X
Cyclohexane EPA 8260D X X
Cyclohexane EPA TO-15 X
Cyclohexane SM 6200 B-2011 X
Cyclohexanone EPA 624.1 X
Cyclohexanone EPA 8260B X X
Cyclohexanone EPA 8260C X X
Cyclohexanone EPA 8260D X X
Cyclohexanone SM 6200 B-2011 X
Dalapon EPA 8151A X X
Dalapon SM 6640 B-2001 X
delta-BHC EPA 608.3 X
delta-BHC EPA 8081A X X
delta-BHC EPA 8081B X X
Demeton EPA 1657 X
Demeton EPA 8141A X X
Demeton EPA 8141B X X
Demeton-o EPA 8141A X X
Demeton-o EPA 8141B X X
Demeton-s EPA 8141A X X
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Demeton-s EPA 8141B X X
Di(2-ethylhexyl) phthalate
(bis(2-Ethylhexyl)phthalate,
DEHP)
EPA 625.1 X
Di(2-ethylhexyl) phthalate
(bis(2-Ethylhexyl)phthalate,
DEHP)
EPA 8270C X X
Di(2-ethylhexyl) phthalate
(bis(2-Ethylhexyl)phthalate,
DEHP)
EPA 8270D X X
Di(2-ethylhexyl) phthalate
(bis(2-Ethylhexyl)phthalate,
DEHP)
EPA 8270E X X
Diallate EPA 625.1 X
Diallate EPA 8270C X X
Diallate EPA 8270D X X
Diallate EPA 8270E X X
Diazinon EPA 1657 X
Diazinon EPA 8141A X X
Diazinon EPA 8141B X X
Dibenz(a, h) acridine EPA 625.1 X
Dibenz(a, h) acridine EPA 8270C X X
Dibenz(a, h) acridine EPA 8270D X X
Dibenz(a, h) acridine EPA 8270E X X
Dibenz(a, j)acridine EPA 625.1 X
Dibenz(a, j)acridine EPA 8270C X X
Dibenz(a, j)acridine EPA 8270D X X
Dibenz(a, j)acridine EPA 8270E X X
Dibenz(a,h)anthracene EPA 610 (HPLC) X
Dibenz(a,h)anthracene EPA 625.1 X
Dibenz(a,h)anthracene EPA 625.1 SIM X
Dibenz(a,h)anthracene EPA 8270C X X
Dibenz(a,h)anthracene EPA 8270C SIM X X
Dibenz(a,h)anthracene EPA 8270D X X
Dibenz(a,h)anthracene EPA 8270D SIM X X
Dibenz(a,h)anthracene EPA 8270E X X
Dibenz(a,h)anthracene EPA 8270E SIM X X
Dibenz(a,h)anthracene EPA 8310 X X
Dibenz(a,h)anthracene MADEP EPH X X
Dibenzo(a,e)pyrene EPA 8270C X X
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Dibenzo(a,e)pyrene EPA 8270D X X
Dibenzo(a,e)pyrene EPA 8270E X X
Dibenzo(a,h) pyrene EPA 8270C X X
Dibenzo(a,h) pyrene EPA 8270D X X
Dibenzo(a,h) pyrene EPA 8270E X X
Dibenzo(a,i) pyrene EPA 8270C X X
Dibenzo(a,i) pyrene EPA 8270D X X
Dibenzo(a,i) pyrene EPA 8270E X X
Dibenzofuran EPA 625.1 X
Dibenzofuran EPA 8270C X X
Dibenzofuran EPA 8270D X X
Dibenzofuran EPA 8270E X X
Dibromoacetic acid EPA 552.2 X
Dibromomethane EPA 524.2 X
Dibromomethane (Methylene
bromide)EPA 624.1 X
Dibromomethane (Methylene
bromide)EPA 8260B X X
Dibromomethane (Methylene
bromide)EPA 8260C X X
Dibromomethane (Methylene
bromide)EPA 8260D X X
Dibromomethane (Methylene
bromide)SM 6200 B-2011 X
Dicamba EPA 8151A X X
Dicamba SM 6640 B-2001 X
Dichlorobromomethane EPA 524.2 X
Dichlorodifluoromethane EPA 524.2 X
Dichlorodifluoromethane
(Freon-12)EPA 624.1 X
Dichlorodifluoromethane
(Freon-12)EPA 8260B X X
Dichlorodifluoromethane
(Freon-12)EPA 8260C X X
Dichlorodifluoromethane
(Freon-12)EPA 8260D X X
Dichlorodifluoromethane
(Freon-12)EPA TO-15 X
Dichlorodifluoromethane
(Freon-12)SM 6200 B-2011 X
Dichloroeacetic acid EPA 552.2 X
Dichloroprop (Dichlorprop)EPA 8151A X X
Dichlorovos (DDVP,
Dichlorvos)EPA 1657 X
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Dichlorovos (DDVP,
Dichlorvos)EPA 8141A X X
Dichlorovos (DDVP,
Dichlorvos)EPA 8141B X X
Dichlorvos EPA 507 X
Dicyclopentadiene EPA 8260B X
Dicyclopentadiene EPA 8260C X
Dicyclopentadiene EPA 8260D X
Dicyclopentadiene EPA TO-15 X
Dieldrin EPA 608.3 X
Dieldrin EPA 8081A X X
Dieldrin EPA 8081B X X
Diesel range organics (DRO)CA LUFT GCMS X
Diesel range organics (DRO)EPA 8015B X X
Diesel range organics (DRO)EPA 8015C X X
Diesel range organics (DRO)EPA 8015D X X
Diesel range organics (DRO)EPA 8270C X X
Diesel range organics (DRO)EPA 8270D X X
Diesel range organics (DRO)EPA 8270E X
Diesel range organics (DRO)IDNR OA-2 X X
Diesel range organics (DRO)LUFT GC X X
Diesel range organics (DRO)LUFT GCMS X
Diesel range organics (DRO)MADEP EPH X
Diesel range organics (DRO)MO-DRO X X
Diesel range organics (DRO)NWTPH-Dx X X
Diesel range organics (DRO)OA-2 X
Diesel range organics (DRO)OK DEQ DRO X X
Diesel range organics (DRO)OK DEQ GRO X
Diesel range organics (DRO)WI(95) DRO X X
Diethyl ether EPA 624.1 X
Diethyl ether EPA 8260B X X
Diethyl ether EPA 8260C X X
Diethyl ether EPA 8260D X X
Diethyl ether SM 6200 B-2011 X
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Diethyl phthalate EPA 625.1 X
Diethyl phthalate EPA 8270C X X
Diethyl phthalate EPA 8270D X X
Diethyl phthalate EPA 8270E X X
Di-isopropylether (DIPE)
(Isopropyl ether)EPA 624.1 X
Di-isopropylether (DIPE)
(Isopropyl ether)EPA 8260B X X
Di-isopropylether (DIPE)
(Isopropyl ether)EPA 8260C X X
Di-isopropylether (DIPE)
(Isopropyl ether)EPA 8260D X X
Di-isopropylether (DIPE)
(Isopropyl ether)SM 6200 B-2011 X
Dimethoate EPA 1657 X
Dimethoate EPA 625.1 X
Dimethoate EPA 8141A X X
Dimethoate EPA 8141B X X
Dimethoate EPA 8270C X X
Dimethoate EPA 8270D X X
Dimethoate EPA 8270E X X
Dimethyl phthalate EPA 625.1 X
Dimethyl phthalate EPA 8270C X X
Dimethyl phthalate EPA 8270D X X
Dimethyl phthalate EPA 8270E X X
Di-n-butyl phthalate EPA 625.1 X
Di-n-butyl phthalate EPA 8270C X X
Di-n-butyl phthalate EPA 8270D X X
Di-n-butyl phthalate EPA 8270E X X
Di-n-octyl phthalate EPA 625.1 X
Di-n-octyl phthalate EPA 8270C X X
Di-n-octyl phthalate EPA 8270D X X
Di-n-octyl phthalate EPA 8270E X X
Dinoseb (2-sec-butyl-4,6-
dinitrophenol, DNBP)EPA 625.1 X
Dinoseb (2-sec-butyl-4,6-
dinitrophenol, DNBP)EPA 8151A X X
Dinoseb (2-sec-butyl-4,6-
dinitrophenol, DNBP)EPA 8270C X X
Dinoseb (2-sec-butyl-4,6-
dinitrophenol, DNBP)EPA 8270D X X
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Dinoseb (2-sec-butyl-4,6-
dinitrophenol, DNBP)EPA 8270E X X
Dinoseb (2-sec-butyl-4,6-
dinitrophenol, DNBP)SM 6640 B-2001 X
Diphenyl ether (Diphenyl
Oxide)EPA 625.1 X
Diphenyl ether (Diphenyl
Oxide)EPA 8270C X X
Diphenyl ether (Diphenyl
Oxide)EPA 8270D X X
Diphenyl ether (Diphenyl
Oxide)EPA 8270E X X
Diphenyl ketone
(Benzophenone)EPA 8270C X
Diphenyl ketone
(Benzophenone)EPA 8270D X
Diphenyl ketone
(Benzophenone)EPA 8270E X
Diphenylamine EPA 625.1 X
Diphenylamine EPA 8270C X X
Diphenylamine EPA 8270D X X
Diphenylamine EPA 8270E X X
Dissolved Carbon SM 5310 B-2011 X
Dissolved organic carbon
(DOC)EPA 9060 X
Dissolved organic carbon
(DOC)EPA 9060A X
Dissolved organic carbon
(DOC)SM 5310 B-2011 X
Dissolved organic carbon
(DOC)SM 5310 C-2011 X
Disulfoton EPA 1657 X
Disulfoton EPA 8141A X X
Disulfoton EPA 8141B X X
Disulfoton EPA 8270C X X
Disulfoton EPA 8270D X X
Disulfoton EPA 8270E X X
Endosulfan I EPA 608.3 X
Endosulfan I EPA 8081A X X
Endosulfan I EPA 8081B X X
Endosulfan II EPA 608.3 X
Endosulfan II EPA 8081A X X
Endosulfan II EPA 8081B X X
Endosulfan sulfate EPA 608.3 X
Endosulfan sulfate EPA 8081A X X
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Endosulfan sulfate EPA 8081B X X
Endrin EPA 608.3 X
Endrin EPA 8081A X X
Endrin EPA 8081B X X
Endrin aldehyde EPA 608.3 X
Endrin aldehyde EPA 8081A X X
Endrin aldehyde EPA 8081B X X
Endrin ketone EPA 608.3 X
Endrin ketone EPA 8081A X X
Endrin ketone EPA 8081B X X
Enterococci ASTM D6503-99 X
Enterococci Enterolert® X
EPH Aliphatic >C10-C12 MADEP EPH X X
EPH Aliphatic >C12-C16 MADEP EPH X X
EPH Aliphatic >C16-C35 MADEP EPH X X
EPH Aliphatic C19-C36 MADEP EPH X X
EPH Aliphatic C9-C18 MADEP EPH X X
EPH Aromatic >C10-C12 MADEP EPH X X
EPH Aromatic >C12-C16 MADEP EPH X X
EPH Aromatic >C16-C21 MADEP EPH X X
EPH Aromatic >C21-C35 MADEP EPH X X
EPH Aromatic C11-C22 MADEP EPH X X
EPH Aromatic C11-C22
Unadjusted MADEP EPH X X
EPN EPA 1657 X
EPN EPA 8141A X X
EPN EPA 8141B X X
Escherichia coli SM 9223 B-2004 X X
Ethane
EPA RSK-175
(GC/FID)X X
Ethanol EPA 624.1 X
Ethanol EPA 8015 X
Ethanol EPA 8015B X X
Ethanol EPA 8015C X X
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Ethanol EPA 8015D X X
Ethanol EPA 8260B X X
Ethanol EPA 8260C X X
Ethanol EPA 8260D X X
Ethanol EPA TO-15 X
Ethanol SM 6200 B-2011 X
Ethene
EPA RSK-175
(GC/FID)X X
Ethion EPA 8141A X
Ethion EPA 8141B X
Ethoprop EPA 1657 X
Ethoprop EPA 507 X
Ethoprop EPA 8141A X X
Ethoprop EPA 8141B X X
Ethyl acetate EPA 624.1 X
Ethyl acetate EPA 8260B X X
Ethyl acetate EPA 8260C X X
Ethyl acetate EPA 8260D X X
Ethyl acetate EPA TO-15 X
Ethyl acetate SM 6200 B-2011 X
Ethyl methacrylate EPA 624.1 X
Ethyl methacrylate EPA 8260B X X
Ethyl methacrylate EPA 8260C X X
Ethyl methacrylate EPA 8260D X X
Ethyl methacrylate SM 6200 B-2011 X
Ethyl methanesulfonate EPA 625.1 X
Ethyl methanesulfonate EPA 8270C X X
Ethyl methanesulfonate EPA 8270D X X
Ethyl methanesulfonate EPA 8270E X X
Ethylbenzene CA LUFT GCMS X X
Ethylbenzene EPA 524.2 X
Ethylbenzene EPA 602 X
Ethylbenzene EPA 624.1 X
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Ethylbenzene EPA 8021B X X
Ethylbenzene EPA 8260B X X
Ethylbenzene EPA 8260C X X
Ethylbenzene EPA 8260D X X
Ethylbenzene EPA TO-15 X
Ethylbenzene
EPA TO-15 GC/MS
SIM X
Ethylbenzene IDNR OA-1 X X
Ethylbenzene MADEP VPH X X
Ethylbenzene OK DEQ GRO X X
Ethylbenzene SM 6200 B-2011 X
Ethylene glycol EPA 8015B X X
Ethylene glycol EPA 8015C X X
Ethylene glycol EPA 8015D X X
Ethyl-t-butyl ether (ETBE) (2-
Ethoxy-2-methylpropane)EPA 624.1 X
Ethyl-t-butyl ether (ETBE) (2-
Ethoxy-2-methylpropane)EPA 8260B X X
Ethyl-t-butyl ether (ETBE) (2-
Ethoxy-2-methylpropane)EPA 8260C X X
Ethyl-t-butyl ether (ETBE) (2-
Ethoxy-2-methylpropane)EPA 8260D X X
Ethyl-t-butyl ether (ETBE) (2-
Ethoxy-2-methylpropane)SM 6200 B-2011 X
Extractable organics halides
(EOX)EPA 9023 X
Extractable Petroleum
Hydrocarbons (EPH)CT ETPH X
Extractable Petroleum
Hydrocarbons (EPH)IDNR OA-2 X X
Extractable Petroleum
Hydrocarbons (EPH)MADEP EPH X X
Extractable Petroleum
Hydrocarbons (EPH)NJDEP EPH 10/08 X
Extractable Petroleum
Hydrocarbons (EPH)TN EPH X X
Extractable Total Petroleum
Hydrocarbons NJDEP EPH 10/08 X
Famphur EPA 625.1 X
Famphur EPA 8141A X
Famphur EPA 8141B X
Famphur EPA 8270C X X
Famphur EPA 8270D X X
Famphur EPA 8270E X X
Fecal coliforms EPA 1681 X X
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Fecal coliforms SM 9223 B-2004 X
Fensulfothion EPA 1657 X
Fensulfothion EPA 8141A X X
Fensulfothion EPA 8141B X X
Fenthion EPA 1657 X
Fenthion EPA 8141A X X
Fenthion EPA 8141B X X
Flash Point ASTM D93 X X
Flash Point ASTM D93-07 X X
Florisil Clean-up EPA 3620 X
Florisil Clean-up EPA 3620C X
Fluoranthene EPA 610 (HPLC) X
Fluoranthene EPA 625.1 X
Fluoranthene EPA 625.1 SIM X
Fluoranthene EPA 8270C X X
Fluoranthene EPA 8270C SIM X X
Fluoranthene EPA 8270D X X
Fluoranthene EPA 8270D SIM X X
Fluoranthene EPA 8270E X X
Fluoranthene EPA 8270E SIM X X
Fluoranthene EPA 8310 X X
Fluoranthene MADEP EPH X X
Fluorene EPA 610 (HPLC) X
Fluorene EPA 625.1 X
Fluorene EPA 625.1 SIM X
Fluorene EPA 8270C X X
Fluorene EPA 8270C SIM X X
Fluorene EPA 8270D X X
Fluorene EPA 8270D SIM X X
Fluorene EPA 8270E X X
Fluorene EPA 8270E SIM X X
Fluorene EPA 8310 X X
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Fluorene MADEP EPH X X
Fluoride EPA 300.0 X X X
Fluoride EPA 9056 X X
Fluoride EPA 9056A X X
Fluoride SM 4110 B-2011 X X
Fluoride SM 4500-F¯ B-2011 X
Fluoride SM 4500-F¯ C-2011 X
Fractional Organic Carbon
(FOC)ASTM D2974 X
Free cyanide EPA 9014 X
Free liquid EPA 9095A X
Free liquid EPA 9095B X X
Gamma Emitters DOE 4.5.2.3 X X
Gamma Emitters EPA 901.1 X X X
Gamma Emitters HASL 300 Ga-01-R X X X X
gamma-BHC (Lindane, gamma-
Hexachlorocyclohexane)EPA 608.3 X
gamma-BHC (Lindane, gamma-
Hexachlorocyclohexane)EPA 8081A X X
gamma-BHC (Lindane, gamma-
Hexachlorocyclohexane)EPA 8081B X X
gamma-Chlordane EPA 608.3 X
gamma-Chlordane EPA 8081A X X
gamma-Chlordane EPA 8081B X X
Gasoline range organics (GRO)CA LUFT GCMS X
Gasoline range organics (GRO)EPA 8015B X X
Gasoline range organics (GRO)EPA 8015C X X
Gasoline range organics (GRO)EPA 8015D X X
Gasoline range organics (GRO)EPA 8260B X X
Gasoline range organics (GRO)EPA 8260C X X
Gasoline range organics (GRO)EPA 8260D X X
Gasoline range organics (GRO)EPA TO-15 X
Gasoline range organics (GRO)IDNR OA-1 X X
Gasoline range organics (GRO)LUFT GC X X
Gasoline range organics (GRO)LUFT GCMS X
Gasoline range organics (GRO)MADEP VPH X
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Gasoline range organics (GRO)MO-GRO X
Gasoline range organics (GRO)NWTPH-Gx X X
Gasoline range organics (GRO)OK DEQ GRO X X
Gasoline range organics (GRO)TN GRO X
Gasoline range organics (GRO)WI(95) GRO X X
Gross alpha-beta EPA 900 X
Gross alpha-beta EPA 9310 X X
Gross-alpha EPA 900 X
Gross-alpha EPA 900.0 (GPC) X X X
Gross-alpha EPA 9310 X X X
Gross-alpha Radium EPA 900.1 X
Gross-beta EPA 900 X
Gross-beta EPA 900.0 (GPC) X X X
Gross-beta EPA 9310 X X X
Guanidine Nitrate EPA 9056 X X
Guanidine Nitrate EPA 9056A X X
Hardness EPA 130.1 X X
Hardness SM 2340 B-2011 X X
Hardness (calc.)EPA 200.7 X X
Hardness (calc.)EPA 200.8 X
Hardness (calc.)SM 2340 B-2011 X X
Helium ASTM D1946-90 X
Heptachlor EPA 608.3 X
Heptachlor EPA 8081A X X
Heptachlor EPA 8081B X X
Heptachlor epoxide EPA 608.3 X
Heptachlor epoxide EPA 8081A X X
Heptachlor epoxide EPA 8081B X X
Heterotrophic plate count
SM 9215 B 2000
(PCA) X X
Hexachlorobenzene EPA 608.3 X
Hexachlorobenzene EPA 625.1 X
Hexachlorobenzene EPA 625.1 SIM X
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Hexachlorobenzene EPA 8081A X X
Hexachlorobenzene EPA 8081B X X
Hexachlorobenzene EPA 8270C X X
Hexachlorobenzene EPA 8270C SIM X X
Hexachlorobenzene EPA 8270D X X
Hexachlorobenzene EPA 8270D SIM X X
Hexachlorobenzene EPA 8270E X X
Hexachlorobenzene EPA 8270E SIM X
Hexachlorobutadiene EPA 624.1 X
Hexachlorobutadiene EPA 625.1 X
Hexachlorobutadiene EPA 8260B X X
Hexachlorobutadiene EPA 8260C X X
Hexachlorobutadiene EPA 8260D X X
Hexachlorobutadiene EPA 8270C X X
Hexachlorobutadiene EPA 8270D X X
Hexachlorobutadiene EPA 8270E X X
Hexachlorobutadiene EPA TO-15 X
Hexachlorobutadiene SM 6200 B-2011 X
Hexachlorobutadiene EPA 524.2 X
Hexachlorocyclopentadiene EPA 625.1 X
Hexachlorocyclopentadiene EPA 8270C X X
Hexachlorocyclopentadiene EPA 8270D X X
Hexachlorocyclopentadiene EPA 8270E X X
Hexachloroethane EPA 624.1 X
Hexachloroethane EPA 625.1 X
Hexachloroethane EPA 8260B X X
Hexachloroethane EPA 8260C X X
Hexachloroethane EPA 8260D X X
Hexachloroethane EPA 8270C X X
Hexachloroethane EPA 8270D X X
Hexachloroethane EPA 8270E X X
Hexachloroethane SM 6200 B-2011 X
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Hexachlorophene EPA 625.1 X
Hexachlorophene EPA 8270C X X
Hexachlorophene EPA 8270D X X
Hexachlorophene EPA 8270E X X
Hexachloropropene EPA 625.1 X
Hexachloropropene EPA 8270C X X
Hexachloropropene EPA 8270D X X
Hexachloropropene EPA 8270E X X
Hydroquinone EPA 625.1 X
Hydroquinone EPA 8270C X
Hydroquinone EPA 8270D X
IC25 (ON) Growth
EPA 1000.0 - Fathead
minnow, 7-day
Chronic, daily
renewal, MHSF 25°C
X
IC25 Reproduction
EPA 1002.0 -
Ceriodaphnia dubia,
7-day Chronic, daily
renewal, MHSF 25°C
X
IC25 Survival
EPA 1000.0 - Fathead
minnow, 7-day
Chronic, daily
renewal, MHSF 25°C
X
IC25 Survival
EPA 1002.0 -
Ceriodaphnia dubia,
7-day Chronic, daily
renewal, MHSF 25°C
X
Ignitability EPA 1010 X X
Ignitability EPA 1010A X X
Indene EPA 625.1 X
Indene EPA 8270C X X
Indene EPA 8270D X X
Indene EPA 8270E X X
Indeno(1,2,3-cd)pyrene EPA 610 (HPLC) X
Indeno(1,2,3-cd)pyrene EPA 625.1 X
Indeno(1,2,3-cd)pyrene EPA 625.1 SIM X
Indeno(1,2,3-cd)pyrene EPA 8270C X X
Indeno(1,2,3-cd)pyrene EPA 8270C SIM X X
Indeno(1,2,3-cd)pyrene EPA 8270D X X
Indeno(1,2,3-cd)pyrene EPA 8270D SIM X X
Indeno(1,2,3-cd)pyrene EPA 8270E X X
Indeno(1,2,3-cd)pyrene EPA 8270E SIM X X
Indeno(1,2,3-cd)pyrene EPA 8310 X X
Indeno(1,2,3-cd)pyrene MADEP EPH X X
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Inorganic Carbon SM 5310 B-2011 X
Iodomethane (Methyl iodide)EPA 624 (extended) X
Iodomethane (Methyl iodide)EPA 624.1 X
Iodomethane (Methyl iodide)EPA 8260B X X
Iodomethane (Methyl iodide)EPA 8260C X X
Iodomethane (Methyl iodide)EPA 8260D X X
Iodomethane (Methyl iodide)EPA TO-15 X
Iodomethane (Methyl iodide)SM 6200 B-2011 X
Iron EPA 200.7 X X
Iron EPA 200.8 X
Iron EPA 6010B X X
Iron EPA 6010C X X
Iron EPA 6010D X X
Iron EPA 6020 X X
Iron EPA 6020A X X
Iron EPA 6020B X X
Iron-(II) (Ferrous Iron)SM 3500-Fe B-2011 X
Isobutyl alcohol (2-Methyl-1-
propanol)EPA 624.1 X
Isobutyl alcohol (2-Methyl-1-
propanol)EPA 8260B X X
Isobutyl alcohol (2-Methyl-1-
propanol)EPA 8260C X X
Isobutyl alcohol (2-Methyl-1-
propanol)EPA 8260D X X
Isobutyl alcohol (2-Methyl-1-
propanol)SM 6200 B-2011 X
Isodrin EPA 625.1 X
Isodrin EPA 8270C X X
Isodrin EPA 8270D X X
Isodrin EPA 8270E X X
Isophorone EPA 625.1 X
Isophorone EPA 8270C X X
Isophorone EPA 8270D X X
Isophorone EPA 8270E X X
Isopropyl alcohol (2-Propanol,
Isopropanol)EPA 624.1 X
Isopropyl alcohol (2-Propanol,
Isopropanol)EPA 8260B X X
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Isopropyl alcohol (2-Propanol,
Isopropanol)EPA 8260C X X
Isopropyl alcohol (2-Propanol,
Isopropanol)EPA 8260D X X
Isopropyl alcohol (2-Propanol,
Isopropanol)EPA TO-15 X
Isopropyl alcohol (2-Propanol,
Isopropanol)SM 6200 B-2011 X
Isopropylbenzene EPA 524.2 X
Isopropylbenzene (Cumene)EPA 624 (extended) X
Isopropylbenzene (Cumene)EPA 624.1 X
Isopropylbenzene (Cumene)EPA 8260B X X
Isopropylbenzene (Cumene)EPA 8260C X X
Isopropylbenzene (Cumene)EPA 8260D X X
Isopropylbenzene (Cumene)EPA TO-15 X
Isopropylbenzene (Cumene)SM 6200 B-2011 X
Isosafrole EPA 8270C X X
Isosafrole EPA 8270D X X
Isosafrole EPA 8270E X X
Isotopic uranium
ASTM D3972-09
Modified (ENV-SOP-
MTJL-0333)
X
Isotopic uranium ASTM D3972-97 X
Kepone EPA 625.1 X
Kepone EPA 8270C X X
Kepone EPA 8270D X X
Kepone EPA 8270E X X
Kjeldahl nitrogen - total EPA 351.2 X
Kjeldahl nitrogen - total
SM 4500-NH3 B-
2011 X
Kjeldahl nitrogen - total
SM 4500-NH3 C-
2011 X
Kjeldahl nitrogen - total
SM 4500-Norg B-
2011 X
Kjeldahl nitrogen - total
SM 4500-Norg C-
2011 X
Kjeldahl nitrogen - total
SM 4500-Norg D-
2011 X X
LC50 Survival
EPA 2000.0 - Fathead
minnow, 48-hr Acute,
nonrenewal, MHSF
25°C
X
LC50 Survival
EPA 2002
Ceriodaphnia dubia
Acute MHSF 25ºC
X
Lead EPA 200.7 X X
Lead EPA 200.8 X X
Lead EPA 6010B X X
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Lead EPA 6010C X X
Lead EPA 6010D X X
Lead EPA 6020 X X
Lead EPA 6020A X X
Lead EPA 6020B X X
Lead-210 DOE 4.5.2.3 X
Lead-210 Eichrom OTW01 X
Lead-210
EICHROM PBS01-
12 X X X X
Lead-210 HASL 300 Ga-01-R X
Legionella Legiolert X X
Lithium EPA 200.7 X X
Lithium EPA 6010B X X
Lithium EPA 6010C X X
Lithium EPA 6010D X X
Lithium EPA 6020 X
Lithium EPA 6020A X
Lithium EPA 6020B X
LOEC Survival EPA 2000 X
m+p-xylene EPA 602 X
m+p-xylene EPA 8021B X X
m+p-xylene EPA 8260B X X
m+p-xylene EPA 8260C X X
m+p-xylene EPA 8260D X
m+p-xylene EPA TO-15 X
m+p-xylene IDNR OA-1 X
m+p-xylene MADEP VPH X X
m+p-xylene SM 6200 B-2011 X
Magnesium EPA 200.7 X X
Magnesium EPA 200.8 X
Magnesium EPA 6010B X X
Magnesium EPA 6010C X X
Magnesium EPA 6010D X X
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Magnesium EPA 6020 X X
Magnesium EPA 6020A X X
Magnesium EPA 6020B X X
Malathion EPA 1657 X
Malathion EPA 8141A X X
Malathion EPA 8141B X X
Manganese EPA 200.7 X X
Manganese EPA 200.8 X X
Manganese EPA 6010B X X
Manganese EPA 6010C X X
Manganese EPA 6010D X X
Manganese EPA 6020 X X
Manganese EPA 6020A X X
Manganese EPA 6020B X X
MCPA EPA 8151A X X
MCPP EPA 8151A X X
Mercury EPA 245.1 X X
Mercury EPA 7470A X
Mercury EPA 7471A X
Mercury EPA 7471B X
Merphos EPA 1657 X
Merphos EPA 507 X
Merphos EPA 8141A X X
Merphos EPA 8141B X X
Methacrylonitrile EPA 624.1 X
Methacrylonitrile EPA 8260B X X
Methacrylonitrile EPA 8260C X X
Methacrylonitrile EPA 8260D X X
Methacrylonitrile SM 6200 B-2011 X
Methane ASTM D1946-90 X
Methane
EPA RSK-175
(GC/FID)X X
Methanol EPA 8015 X
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Methanol EPA 8015B X X
Methanol EPA 8015C X X
Methanol EPA 8015D X X
Methanol EPA 8260B X
Methanol EPA 8260C X
Methanol EPA TO-15 X
Methanol SM 6200 B-2011 X
Methapyrilene EPA 625.1 X
Methapyrilene EPA 8270C X X
Methapyrilene EPA 8270D X X
Methapyrilene EPA 8270E X X
Methoxychlor EPA 608.3 X
Methoxychlor EPA 8081A X X
Methoxychlor EPA 8081B X X
Methyl acetate EPA 624.1 X
Methyl acetate EPA 8260B X X
Methyl acetate EPA 8260C X X
Methyl acetate EPA 8260D X X
Methyl acetate SM 6200 B-2011 X
Methyl acrylate EPA 624.1 X
Methyl acrylate EPA 8260B X X
Methyl acrylate EPA 8260C X X
Methyl acrylate EPA 8260D X X
Methyl acrylate SM 6200 B-2011 X
Methyl bromide
(Bromomethane)EPA 624.1 X
Methyl bromide
(Bromomethane)EPA 8260B X X
Methyl bromide
(Bromomethane)EPA 8260C X X
Methyl bromide
(Bromomethane)EPA 8260D X X
Methyl bromide
(Bromomethane)EPA TO-15 X
Methyl bromide
(Bromomethane)SM 6200 B-2011 X
Methyl chloride
(Chloromethane)EPA 624.1 X
Methyl chloride
(Chloromethane)EPA 8260B X X
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Methyl chloride
(Chloromethane)EPA 8260C X X
Methyl chloride
(Chloromethane)EPA 8260D X X
Methyl chloride
(Chloromethane)EPA TO-15 X
Methyl chloride
(Chloromethane)
EPA TO-15 GC/MS
SIM X
Methyl chloride
(Chloromethane)SM 6200 B-2011 X
Methyl ethyl ketone EPA 524.2 X
Methyl iodide EPA 524.2 X
Methyl isobutyl ketone EPA 524.2 X
Methyl methacrylate EPA 624.1 X
Methyl methacrylate EPA 8260B X X
Methyl methacrylate EPA 8260C X X
Methyl methacrylate EPA 8260D X X
Methyl methacrylate EPA TO-15 X
Methyl methacrylate SM 6200 B-2011 X
Methyl methanesulfonate EPA 625.1 X
Methyl methanesulfonate EPA 8270C X X
Methyl methanesulfonate EPA 8270D X X
Methyl methanesulfonate EPA 8270E X X
Methyl parathion (Parathion,
methyl)EPA 1657 X
Methyl parathion (Parathion,
methyl)EPA 625.1 X
Methyl parathion (Parathion,
methyl)EPA 8141A X X
Methyl parathion (Parathion,
methyl)EPA 8141B X X
Methyl parathion (Parathion,
methyl)EPA 8270C X X
Methyl parathion (Parathion,
methyl)EPA 8270D X X
Methyl parathion (Parathion,
methyl)EPA 8270E X X
Methyl tert-butyl ether EPA 524.2 X
Methyl tert-butyl ether (MTBE)EPA 602 X
Methyl tert-butyl ether (MTBE)EPA 624.1 X
Methyl tert-butyl ether (MTBE)EPA 8021B X X
Methyl tert-butyl ether (MTBE)EPA 8260B X X
Methyl tert-butyl ether (MTBE)EPA 8260C X X
Methyl tert-butyl ether (MTBE)EPA 8260D X X
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Methyl tert-butyl ether (MTBE)EPA TO-15 X
Methyl tert-butyl ether (MTBE)IDNR OA-1 X X
Methyl tert-butyl ether (MTBE)LUFT GCMS X X
Methyl tert-butyl ether (MTBE)MADEP VPH X X
Methyl tert-butyl ether (MTBE)OK DEQ GRO X X
Methyl tert-butyl ether (MTBE)SM 6200 B-2011 X
Methyl-2,4,6-
trinitrophenylnitramine (tetryl)EPA 8330 X X
Methyl-2,4,6-
trinitrophenylnitramine (tetryl)EPA 8330A X X
Methyl-2,4,6-
trinitrophenylnitramine (tetryl)EPA 8330B X X
Methylcyclohexane EPA 624.1 X
Methylcyclohexane EPA 8260B X X
Methylcyclohexane EPA 8260C X X
Methylcyclohexane EPA 8260D X X
Methylcyclohexane EPA TO-15 X
Methylcyclohexane SM 6200 B-2011 X
Methylene bromide EPA 524.2 X
Methylene chloride EPA 524.2 X
Methylene chloride
(Dichloromethane)EPA 624.1 X
Methylene chloride
(Dichloromethane)EPA 8260B X X
Methylene chloride
(Dichloromethane)EPA 8260C X X
Methylene chloride
(Dichloromethane)EPA 8260D X X
Methylene chloride
(Dichloromethane)EPA TO-15 X
Methylene chloride
(Dichloromethane)SM 6200 B-2011 X
Metolachlor EPA 507 X X
Metribuzin EPA 507 X X
Mevinphos EPA 1657 X
Mevinphos EPA 507 X
Mevinphos EPA 8141A X X
Mevinphos EPA 8141B X X
Microextraction of Organics in
Water EPA 3511 X X
Microwave Assisted Acid
Digestion of Aqueous Samples
and Extracts
EPA 3015A X
Microwave Assisted Acid
Digestion of Sediments,
Sludges, Soils, and Oils
EPA 3051 X
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Microwave Assisted Acid
Digestion of Sediments,
Sludges, Soils, and Oils
EPA 3051A X
Microwave Assisted Acid
Digestion of Sediments,
Sludges, Soils, and Oils
EPA 3052 X
Microwave Extraction EPA 3546 X
Mirex EPA 8270C X
Mirex EPA 8270D X
Molybdenum EPA 200.7 X X
Molybdenum EPA 200.8 X X
Molybdenum EPA 6010B X X
Molybdenum EPA 6010C X X
Molybdenum EPA 6010D X X
Molybdenum EPA 6020 X X
Molybdenum EPA 6020A X X
Molybdenum EPA 6020B X X
m-Xylene EPA 624.1 X
m-Xylene EPA 8021B X X
m-Xylene EPA 8260B X X
m-Xylene EPA 8260C X X
m-Xylene EPA 8260D X X
m-Xylene EPA TO-15 X
m-Xylene EPA 524.2 X
Naled EPA 1657 X
Naled EPA 8141A X X
Naled EPA 8141B X X
Naphthalene EPA 610 (HPLC) X
Naphthalene EPA 624.1 X
Naphthalene EPA 625.1 X
Naphthalene EPA 625.1 SIM X
Naphthalene EPA 8021B X
Naphthalene EPA 8260B X X
Naphthalene EPA 8260C X X
Naphthalene EPA 8260D X X
Naphthalene EPA 8270C X X
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Naphthalene EPA 8270C SIM X X
Naphthalene EPA 8270D X X
Naphthalene EPA 8270D SIM X X
Naphthalene EPA 8270E X X
Naphthalene EPA 8270E SIM X X
Naphthalene EPA 8310 X X
Naphthalene EPA TO-15 X
Naphthalene MADEP EPH X X
Naphthalene MADEP VPH X X
Naphthalene OK DEQ GRO X X
Naphthalene SM 6200 B-2011 X
Naphthalene EPA 524.2 X
n-Butane EPA TO-15 X
n-Butyl alcohol (1-Butanol, n-
Butanol)EPA 624.1 X
n-Butyl alcohol (1-Butanol, n-
Butanol)EPA 8260B X X
n-Butyl alcohol (1-Butanol, n-
Butanol)EPA 8260C X X
n-Butyl alcohol (1-Butanol, n-
Butanol)EPA 8260D X X
n-Butyl alcohol (1-Butanol, n-
Butanol)SM 6200 B-2011 X
n-Butylbenzene EPA 524.2 X
n-Butylbenzene EPA 624 (extended) X
n-Butylbenzene EPA 624.1 X
n-Butylbenzene EPA 8260B X X
n-Butylbenzene EPA 8260C X X
n-Butylbenzene EPA 8260D X X
n-Butylbenzene EPA TO-15 X
n-Butylbenzene SM 6200 B-2011 X
n-Decane EPA 625.1 X
n-Decane EPA 8270C X X
n-Decane EPA 8270D X X
n-Decane EPA 8270E X X
Neptunium-237
EPA 907 Modified
(ENV-SOP-MTJL-
0332)
X X X X
n-Heptane EPA 624.1 X
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n-Heptane EPA 8260B X
n-Heptane EPA 8260C X
n-Heptane EPA 8260D X
n-Heptane EPA TO-15 X
n-Hexane EPA 624.1 X
n-Hexane EPA 8260B X X
n-Hexane EPA 8260C X X
n-Hexane EPA 8260D X X
n-Hexane EPA TO-15 X
n-Hexane SM 6200 B-2011 X
n-Hexane Extractable Material
(O&G)EPA 1664A (HEM) X X
n-Hexane Extractable Material
(O&G)
EPA 1664A (SGT-
HEM) X
n-Hexane Extractable Material
(O&G)EPA 1664B X
n-Hexane Extractable Material
(O&G)EPA 9070A X
n-Hexane Extractable Material
(O&G)EPA 9071A X
n-Hexane Extractable Material
(O&G)EPA 9071B X
Nickel EPA 200.7 X X
Nickel EPA 200.8 X X
Nickel EPA 6010B X X
Nickel EPA 6010C X X
Nickel EPA 6010D X X
Nickel EPA 6020 X X
Nickel EPA 6020A X X
Nickel EPA 6020B X X
Nitrate as N EPA 300.0 X X X
Nitrate as N EPA 353.2 X
Nitrate as N EPA 9056 X X
Nitrate as N EPA 9056A X X
Nitrate as N SM 4110 B-2011 X X
Nitrate as N
SM 4500-NO3¯ F-
2011 X X
Nitrate-Nitrite EPA 300.0 X X X
Nitrate-Nitrite EPA 353.2 X X
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Nitrate-Nitrite EPA 9056 X X
Nitrate-Nitrite EPA 9056A X X
Nitrate-Nitrite SM 4110 B-2011 X X
Nitrate-Nitrite
SM 4500-NO3¯ F-
2011 X X
Nitrite as N EPA 300.0 X X X
Nitrite as N EPA 353.2 X
Nitrite as N EPA 9056 X X
Nitrite as N EPA 9056A X X
Nitrite as N SM 4110 B-2011 X X
Nitrite as N
SM 4500-NO3¯ F-
2011 X
Nitrobenzene EPA 625.1 X
Nitrobenzene EPA 8270C X X
Nitrobenzene EPA 8270D X X
Nitrobenzene EPA 8270E X X
Nitrobenzene EPA 8330 X X
Nitrobenzene EPA 8330A X X
Nitrobenzene EPA 8330B X X
Nitrocellulose EPA 353.2 Modified X X
Nitrocellulose
US Army
#ADA067081 X X
Nitroglycerin EPA 8330 X X
Nitroglycerin EPA 8330A X X
Nitroglycerin EPA 8330B X X
Nitroguanidine EPA 8330 X X
Nitroguanidine EPA 8330A X X
Nitroguanidine EPA 8330B X X
n-Nitrosodiethylamine EPA 625.1 X
n-Nitrosodiethylamine EPA 8270C X X
n-Nitrosodiethylamine EPA 8270D X X
n-Nitrosodiethylamine EPA 8270E X X
n-Nitrosodimethylamine EPA 625.1 X
n-Nitrosodimethylamine EPA 625.1 SIM X
n-Nitrosodimethylamine EPA 8270C X X
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n-Nitrosodimethylamine EPA 8270C SIM X X
n-Nitrosodimethylamine EPA 8270D X X
n-Nitrosodimethylamine EPA 8270D SIM X X
n-Nitrosodimethylamine EPA 8270E X X
n-Nitrosodimethylamine EPA 8270E SIM X
n-Nitroso-di-n-butylamine EPA 625.1 X
n-Nitroso-di-n-butylamine EPA 8260B X
n-Nitroso-di-n-butylamine EPA 8260C X
n-Nitroso-di-n-butylamine EPA 8260D X
n-Nitroso-di-n-butylamine EPA 8270C X X
n-Nitroso-di-n-butylamine EPA 8270D X X
n-Nitroso-di-n-butylamine EPA 8270E X X
n-Nitrosodi-n-propylamine EPA 625.1 X
n-Nitrosodi-n-propylamine EPA 8270C X X
n-Nitrosodi-n-propylamine EPA 8270D X X
n-Nitrosodi-n-propylamine EPA 8270E X X
n-Nitrosodiphenylamine EPA 625.1 X
n-Nitrosodiphenylamine EPA 8270C X X
n-Nitrosodiphenylamine EPA 8270D X X
n-Nitrosodiphenylamine EPA 8270E X X
n-Nitrosomethylethylamine EPA 625.1 X
n-Nitrosomethylethylamine EPA 8270C X X
n-Nitrosomethylethylamine EPA 8270D X X
n-Nitrosomethylethylamine EPA 8270E X X
n-Nitrosomorpholine EPA 625.1 X
n-Nitrosomorpholine EPA 8270C X X
n-Nitrosomorpholine EPA 8270D X X
n-Nitrosomorpholine EPA 8270E X X
n-Nitrosopiperidine EPA 625.1 X
n-Nitrosopiperidine EPA 8270C X X
n-Nitrosopiperidine EPA 8270D X X
n-Nitrosopiperidine EPA 8270E X X
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n-Nitrosopyrrolidine EPA 625.1 X
n-Nitrosopyrrolidine EPA 8270C X X
n-Nitrosopyrrolidine EPA 8270D X X
n-Nitrosopyrrolidine EPA 8270E X X
n-Nonane EPA TO-15 X
n-Octadecane EPA 625.1 X
n-Octadecane EPA 8270C X X
n-Octadecane EPA 8270D X X
n-Octadecane EPA 8270E X X
n-Octane EPA 8260B X X
n-Octane EPA 8260C X X
n-Octane EPA 8260D X X
n-Octane SM 6200 B-2011 X
NOEC (ON) Growth
EPA 1000.0 - Fathead
minnow, 7-day
Chronic, daily
renewal, MHSF 25°C
X
NOEC Reproduction
EPA 1002.0 -
Ceriodaphnia dubia,
7-day Chronic, daily
renewal, MHSF 25°C
X
NOEC Survival
EPA 1000.0 - Fathead
minnow, 7-day
Chronic, daily
renewal, MHSF 25°C
X
NOEC Survival
EPA 1002.0 -
Ceriodaphnia dubia,
7-day Chronic, daily
renewal, MHSF 25°C
X
NOEC Survival
EPA 2002
Ceriodaphnia dubia
Acute MHSF 25ºC
X
non-Polar Extractable Material
(TPH)EPA 1664A (HEM) X
n-Pentane EPA TO-15 X
n-Propane
EPA RSK-175
(GC/FID) X
n-Propylbenzene EPA 524.2 X
n-Propylbenzene EPA 624 (extended) X
n-Propylbenzene EPA 624.1 X
n-Propylbenzene EPA 8260B X X
n-Propylbenzene EPA 8260C X X
n-Propylbenzene EPA 8260D X X
n-Propylbenzene EPA TO-15 X
n-Propylbenzene SM 6200 B-2011 X
o,o,o-Triethyl
phosphorothioate EPA 625.1 X
o,o,o-Triethyl
phosphorothioate EPA 8270C X X
o,o,o-Triethyl
phosphorothioate EPA 8270D X X
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o,o,o-Triethyl
phosphorothioate EPA 8270E X X
Octahydro-1,3,5,7-tetranitro-
1,3,5,7-tetrazocine (HMX)EPA 8330 X X
Octahydro-1,3,5,7-tetranitro-
1,3,5,7-tetrazocine (HMX)EPA 8330A X X
Octahydro-1,3,5,7-tetranitro-
1,3,5,7-tetrazocine (HMX)EPA 8330B X X
Odor SM 2150 B X X
Oil & Grease EPA 1664A (HEM) X X
Oil & Grease EPA 1664B X X
Oil & Grease
EPA 1664B (SGT-
HEM) X
Oil & Grease EPA 9070A X
Oil & Grease EPA 9071B X
Oil-Range Organics (ORO)EPA 8015B X X
Oil-Range Organics (ORO)EPA 8015C X X
Oil-Range Organics (ORO)EPA 8015D X X
Organic nitrogen EPA 350.1 X
Organic nitrogen EPA 351.1 X
Organic nitrogen EPA 351.2 X
Organic nitrogen
EPA 351.2 minus
EPA 350.1 X
Organic nitrogen EPA 351.3 X
Organic nitrogen EPA 351.4 X
Organic nitrogen
SM 4500-Norg D-
2011 minus SM 4500-
NH3 G-2011
X
Organic nitrogen
TKN minus
AMMONIA X
Orthophosphate EPA 9056A X
Orthophosphate as P EPA 300.0 X
Orthophosphate as P EPA 365.2 X X
Orthophosphate as P EPA 9056 X
Orthophosphate as P EPA 9056A X
Orthophosphate as P SM 4500-P E-2011 X X
Oxidation Reduction Potential SM 2580 B X
Oxygen ASTM D1946-90 X
Oxygen, dissolved SM 4500-O C-2011 X
Oxygen, dissolved SM 4500-O G-2011 X
o-Xylene EPA 602 X
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o-Xylene EPA 624.1 X
o-Xylene EPA 8021B X X
o-Xylene EPA 8260B X X
o-Xylene EPA 8260C X X
o-Xylene EPA 8260D X X
o-Xylene EPA TO-15 X
o-Xylene IDNR OA-1 X
o-Xylene MADEP VPH X X
o-Xylene OK DEQ GRO X
o-Xylene SM 6200 B-2011 X
o-Xylene EPA 524.2 X
Parathion, ethyl EPA 1657 X
Parathion, ethyl EPA 625.1 X
Parathion, ethyl EPA 8141A X X
Parathion, ethyl EPA 8141B X X
Parathion, ethyl EPA 8270C X X
Parathion, ethyl EPA 8270D X X
Parathion, ethyl EPA 8270E X X
p-Dimethylaminoazobenzene EPA 625.1 X
p-Dimethylaminoazobenzene EPA 8270C X X
p-Dimethylaminoazobenzene EPA 8270D X X
p-Dimethylaminoazobenzene EPA 8270E X X
Pentachlorobenzene EPA 625.1 X
Pentachlorobenzene EPA 8270C X X
Pentachlorobenzene EPA 8270D X X
Pentachlorobenzene EPA 8270E X X
Pentachloroethane EPA 624.1 X
Pentachloroethane EPA 625 (extended) X
Pentachloroethane EPA 625.1 X
Pentachloroethane EPA 8260B X X
Pentachloroethane EPA 8260C X X
Pentachloroethane EPA 8260D X X
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Pentachloroethane EPA 8270C X X
Pentachloroethane EPA 8270D X X
Pentachloroethane EPA 8270E X X
Pentachloroethane SM 6200 B-2011 X
Pentachloronitrobenzene EPA 625.1 X
Pentachloronitrobenzene EPA 8270C X X
Pentachloronitrobenzene EPA 8270D X X
Pentachloronitrobenzene EPA 8270E X X
Pentachlorophenol EPA 625.1 X
Pentachlorophenol EPA 8151A X X
Pentachlorophenol EPA 8270C X X
Pentachlorophenol EPA 8270D X X
Pentachlorophenol EPA 8270E X X
Pentaerythritoltetranitrate EPA 8330 X X
Pentaerythritoltetranitrate EPA 8330A X X
Pentaerythritoltetranitrate EPA 8330B X X
Percent ash ASTM D482 X
Perchlorate EPA 314.0 X X X
Petroleum Organics CT ETPH X
Petroleum Organics FL PRO X
Petroleum Organics LUFT GC X
Petroleum Organics NWTPH-HCID X X
Petroleum Organics Texas 1006 X X
Petroleum Volatile Organic
Compounds (PVOC)WI(95) GRO X X
pH EPA 150.1 X X
pH EPA 9040B X X
pH EPA 9040C X X
pH EPA 9045C X X
pH EPA 9045D X X
pH SM 4500-H+ B-2011 X X
Phenacetin EPA 625.1 X
Phenacetin EPA 8270C X X
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Phenacetin EPA 8270D X X
Phenacetin EPA 8270E X X
Phenanthrene EPA 610 (HPLC) X
Phenanthrene EPA 625.1 X
Phenanthrene EPA 625.1 SIM X
Phenanthrene EPA 8270C X X
Phenanthrene EPA 8270C SIM X X
Phenanthrene EPA 8270D X X
Phenanthrene EPA 8270D SIM X X
Phenanthrene EPA 8270E X X
Phenanthrene EPA 8270E SIM X X
Phenanthrene EPA 8310 X X
Phenanthrene MADEP EPH X X
Phenol EPA 420.4 X
Phenol EPA 625.1 X
Phenol EPA 8270C X X
Phenol EPA 8270D X X
Phenol EPA 8270E X X
Phenols EPA 420.1 X
Phenols EPA 420.4 X
Phenols SM 3500 D-2005 X
Phorate EPA 1657 X
Phorate EPA 625.1 X
Phorate EPA 8141A X X
Phorate EPA 8141B X X
Phorate EPA 8270C X X
Phorate EPA 8270D X X
Phorate EPA 8270E X X
Phosmet (Imidan)EPA 8141A X
Phosmet (Imidan)EPA 8141B X
Phosphorus EPA 200.7 X X
Phosphorus EPA 6010B X
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Phosphorus EPA 6010C X X
Phosphorus EPA 6010D X
Photon Emitters DOE 4.5.2.3 X
Photon Emitters EPA 901.1 X
Photon Emitters HASL 300 Ga-01-R X
Phthalic anhydride EPA 625.1 X
Phthalic anhydride EPA 8270C X X
Phthalic anhydride EPA 8270D X X
Phthalic anhydride EPA 8270E X
Pimephales promelas EPA 1000 X
Pimephales promelas EPA 2000 X
Plutonium-238
EPA 907 Modified
(ENV-SOP-MTJL-
0332)
X X X X
Plutonium-239/240
EPA 907 Modified
(ENV-SOP-MTJL-
0332)
X X X X
Plutonium-241
EPA 907 Modified
(ENV-SOP-MTJL-
0332)
X X X X
Polonium-210
DOE EML Po-02-
RC X
Polonium-210 HASL 300 Po-02-RC X X X X
Potassium EPA 200.7 X X
Potassium EPA 200.8 X
Potassium EPA 6010B X X
Potassium EPA 6010C X X
Potassium EPA 6010D X X
Potassium EPA 6020 X X
Potassium EPA 6020A X X
Potassium EPA 6020B X X
Preparation/Extraction EPA 200.2 X
Pronamide (Kerb)EPA 625.1 X
Pronamide (Kerb)EPA 8270C X X
Pronamide (Kerb)EPA 8270D X X
Pronamide (Kerb)EPA 8270E X X
Propane
EPA RSK-175
(GC/FID)X X
Propionitrile (Ethyl cyanide)EPA 624.1 X
Propionitrile (Ethyl cyanide)EPA 8260B X X
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Propionitrile (Ethyl cyanide)EPA 8260C X X
Propionitrile (Ethyl cyanide)EPA 8260D X X
Propionitrile (Ethyl cyanide)SM 6200 B-2011 X
Propylene EPA TO-15 X
Propylene Glycol EPA 8015B X X
Propylene Glycol EPA 8015C X
Propylene Glycol
EPA 8015C
(extended) X X
Propylene Glycol EPA 8015D X X
Purge and trap for aqueous
phase samples EPA 5030 X
Purge and trap for aqueous
phase samples EPA 5030A X
Purge and trap for aqueous
phase samples EPA 5030B X
Purge and trap for aqueous
phase samples EPA 5030C X
p-Xylene EPA 624.1 X
p-Xylene EPA 8021B X X
p-Xylene EPA 8260B X X
p-Xylene EPA 8260C X X
p-Xylene EPA 8260D X X
p-Xylene EPA TO-15 X
Pyrene EPA 610 (HPLC) X
Pyrene EPA 625.1 X
Pyrene EPA 625.1 SIM X
Pyrene EPA 8270C X X
Pyrene EPA 8270C SIM X X
Pyrene EPA 8270D X X
Pyrene EPA 8270D SIM X X
Pyrene EPA 8270E X X
Pyrene EPA 8270E SIM X X
Pyrene EPA 8310 X X
Pyrene MADEP EPH X X
Pyridine EPA 625.1 X
Pyridine EPA 8270C X X
Pyridine EPA 8270D X X
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Pyridine EPA 8270E X X
Quinoline EPA 625.1 X
Quinoline EPA 8270C X X
Quinoline EPA 8270D X X
Quinoline EPA 8270E X X
Radium-226 EPA 903.0 X
Radium-226 EPA 903.1 X X
Radium-226 EPA 9315 X
Radium-226 HASL 300 Ra-04-RC X
Radium-226
SM 7500 Ra B
Modified X X X X
Radium-226 SM 7500-Ra B X X
Radium-226 SM 7500-Ra B (GPC) X X
Radium-228 EPA 904 X
Radium-228 EPA 904.0 X X X
Radium-228 EPA 9320 X X
Radon SM 7500-Rn B X X
RDX (hexahydro-1,3,5-trinitro-
1,3,5-triazine)EPA 8330 X X
RDX (hexahydro-1,3,5-trinitro-
1,3,5-triazine)EPA 8330A X X
RDX (hexahydro-1,3,5-trinitro-
1,3,5-triazine)EPA 8330B X X
Reactive Cyanide EPA 9010C X
Reactive Cyanide EPA 9014 X
Reactive sulfide EPA 9034 X X
Residue-filterable (TDS)SM 2540 C-2011 X
Residue-nonfilterable (TSS)SM 2540 D-2011 X
Residue-nonfilterable (TSS)USGS I-3765-85 X
Residue-settleable SM 2540 F-2011 X
Residue-total SM 2540 B-2011 X
Residue-volatile EPA 160.4 X
Residue-volatile SM 2540 E-2011 X
Ronnel EPA 1657 X
Ronnel EPA 8141A X X
Ronnel EPA 8141B X X
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Safrole EPA 625.1 X
Safrole EPA 8270C X X
Safrole EPA 8270D X X
Safrole EPA 8270E X X
Salinity SM 2520 B-2011 X
sec-Butylbenzene EPA 524.2 X
sec-Butylbenzene EPA 624 (extended) X
sec-Butylbenzene EPA 624.1 X
sec-Butylbenzene EPA 8260B X X
sec-Butylbenzene EPA 8260C X X
sec-Butylbenzene EPA 8260D X X
sec-Butylbenzene EPA TO-15 X
sec-Butylbenzene SM 6200 B-2011 X
Selenium EPA 200.7 X X
Selenium EPA 200.8 X X
Selenium EPA 6010B X X
Selenium EPA 6010C X X
Selenium EPA 6010D X X
Selenium EPA 6020 X X
Selenium EPA 6020A X X
Selenium EPA 6020B X X
Separatory Funnel Liquid-liquid
extraction EPA 3510C X
Silica as SiO2 EPA 200.7 X X
Silica as SiO2 EPA 6010B X
Silica as SiO2 EPA 6010C X
Silica as SiO2 EPA 6010D X
Silica Gel Clean-up EPA 3630C X X
Silica Gel Treated n-hexane
Extractable Material (SGT-
HEM)
EPA 1664A (HEM) X X
Silica Gel Treated n-hexane
Extractable Material (SGT-
HEM)
EPA 1664B X
Silica Gel Treated n-hexane
Extractable Material (SGT-
HEM)
EPA 9071B X
Silica-dissolved EPA 200.7 X
Silicon EPA 200.7 X
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Silicon EPA 6010B X
Silicon EPA 6010C X
Silicon EPA 6010D X
Silver EPA 200.7 X X
Silver EPA 200.8 X X
Silver EPA 6010B X X
Silver EPA 6010C X X
Silver EPA 6010D X X
Silver EPA 6020 X X
Silver EPA 6020A X X
Silver EPA 6020B X X
Silvex (2,4,5-TP)EPA 8151A X X
Silvex (2,4,5-TP)SM 6640 B-2001 X
Silvex (2,4,5-TP)SM 6640 B-2006 X
Simazine EPA 507 X X
Simazine EPA 8141B X
Sodium EPA 200.7 X X
Sodium EPA 200.8 X
Sodium EPA 6010B X X
Sodium EPA 6010C X X
Sodium EPA 6010D X X
Sodium EPA 6020 X X
Sodium EPA 6020A X X
Sodium EPA 6020B X X
Solid-Phase Extraction (SPE)EPA 3535A X
Soxhlet Extraction EPA 3540C X
Specific Gravity (Relative
Density)SM 2710 F-2011 X
Specific Gravity of Sludge SM 2710 F-2011 X
Stirophos EPA 1657 X
Stirophos EPA 8141A X X
Stirophos EPA 8141B X X
Strontium EPA 200.7 X X
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Strontium EPA 200.8 X
Strontium EPA 6010B X X
Strontium EPA 6010C X X
Strontium EPA 6010D X X
Strontium EPA 6020 X X
Strontium EPA 6020A X X
Strontium EPA 6020B X X
Strontium-89 DOE EML Sr-01-RC X
Strontium-89 EPA 905.0 X X
Strontium-89
HASL 300 Sr-01-RC
(GPC) X
Strontium-89, 90 EPA 905 X X
Strontium-90 DOE EML Sr-02-RC X
Strontium-90 EPA 905 X X
Strontium-90 EPA 905.0 X X
Strontium-90
HASL 300 Sr-02-RC
(GPC) X
Styrene EPA 624.1 X
Styrene EPA 8260B X X
Styrene EPA 8260C X X
Styrene EPA 8260D X X
Styrene EPA TO-15 X
Styrene SM 6200 B-2011 X
Styrene EPA 524.2 X
Sulfate EPA 300.0 X X X
Sulfate EPA 9056 X X
Sulfate EPA 9056A X X
Sulfate SM 4110 B-2011 X X
Sulfide EPA 9030A X
Sulfide EPA 9030B X X
Sulfide EPA 9034 X X
Sulfide SM 4500-S2¯ D-2011 X
Sulfite-SO3
SM 4500-SO3¯ B-
2011 X
Sulfotepp EPA 1657 X
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Sulfotepp EPA 625.1 X
Sulfotepp EPA 8141A X X
Sulfotepp EPA 8141B X X
Sulfotepp EPA 8270C X X
Sulfotepp EPA 8270D X X
Sulfotepp EPA 8270E X X
Sulfur EPA 6010B X
Sulfur EPA 6010C X
Sulfur EPA 6010D X
Sulfur Clean-Up EPA 3660B X X
Sulfuric acid/permanganate
clean-up EPA 3665A X X
Surfactants - MBAS SM 5540 C-2011 X X
Synthetic Precipitation
Leaching Procedure EPA 1312 X X
T-amylmethylether (TAME)EPA 624.1 X
T-amylmethylether (TAME)EPA 8260B X X
T-amylmethylether (TAME)EPA 8260C X X
T-amylmethylether (TAME)EPA 8260D X X
T-amylmethylether (TAME)SM 6200 B-2011 X
Technetium-99 DOE EML Tc-02-RC X X X X
Temperature, deg. C SM 2550 B-2000 X X
Terbufos EPA 8141A X
Terbufos EPA 8141B X X
tert-Amyl-ethyl ether (TAEE)
EPA 8260B
(extended) X X
tert-Amyl-ethyl ether (TAEE)EPA 8260C X X
tert-Amyl-ethyl ether (TAEE)EPA 8260D X
tert-Amyl-ethyl ether (TAEE)EPA TO-15 X
tert-Amyl-ethyl ether (TAEE)SM 6200 B-2011 X
tert-Butyl alcohol EPA 602 X
tert-Butyl alcohol EPA 624.1 X
tert-Butyl alcohol EPA 8260B X X
tert-Butyl alcohol EPA 8260C X X
tert-Butyl alcohol EPA 8260D X X
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tert-Butyl alcohol EPA TO-15 X
tert-Butyl alcohol SM 6200 B-2011 X
tert-Butyl formate EPA 624.1 X
tert-Butyl formate EPA 8260B X X
tert-Butyl formate EPA 8260C X X
tert-Butyl formate EPA 8260D X
tert-Butyl formate SM 6200 B-2011 X
tert-Butylbenzene EPA 524.2 X
tert-Butylbenzene EPA 624 (extended) X
tert-Butylbenzene EPA 624.1 X
tert-Butylbenzene EPA 8260B X X
tert-Butylbenzene EPA 8260C X X
tert-Butylbenzene EPA 8260D X X
tert-Butylbenzene EPA TO-15 X
tert-Butylbenzene SM 6200 B-2011 X
Tetrachloroethene EPA 524.2 X
Tetrachloroethylene
(Perchloroethylene)EPA 624.1 X
Tetrachloroethylene
(Perchloroethylene)EPA 8260B X X
Tetrachloroethylene
(Perchloroethylene)EPA 8260C X X
Tetrachloroethylene
(Perchloroethylene)EPA 8260D X X
Tetrachloroethylene
(Perchloroethylene)EPA TO-15 X
Tetrachloroethylene
(Perchloroethylene)
EPA TO-15 GC/MS
SIM X
Tetrachloroethylene
(Perchloroethylene)SM 6200 B-2011 X
Tetrachlorovinphos EPA 8141B X
Tetraethyl pyrophosphate
(TEPP)EPA 1657 X
Tetraethyl pyrophosphate
(TEPP)EPA 8141A X X
Tetraethyl pyrophosphate
(TEPP)EPA 8141B X X
Tetrahydrofuran EPA 524.2 X
Tetrahydrofuran (THF)EPA 624.1 X
Tetrahydrofuran (THF)EPA 8260B X X
Tetrahydrofuran (THF)EPA 8260C X X
Tetrahydrofuran (THF)EPA 8260D X X
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Tetrahydrofuran (THF)EPA TO-15 X
Tetrahydrofuran (THF)SM 6200 B-2011 X
Thallium EPA 200.7 X X
Thallium EPA 200.8 X X
Thallium EPA 6010B X X
Thallium EPA 6010C X X
Thallium EPA 6010D X X
Thallium EPA 6020 X X
Thallium EPA 6020A X X
Thallium EPA 6020B X X
Thionazin (Zinophos)EPA 625.1 X
Thionazin (Zinophos)EPA 8270C X X
Thionazin (Zinophos)EPA 8270D X X
Thionazin (Zinophos)EPA 8270E X X
Thorium EPA 200.8 X
Thorium EPA 6020 X X
Thorium EPA 6020A X X
Thorium EPA 6020B X X
Thorium-228
LANL ER200
Modified X X X X
Thorium-230
LANL ER200
Modified X X X X
Thorium-232
LANL ER200
Modified X X X X
Tin EPA 200.7 X X
Tin EPA 200.8 X X
Tin EPA 6010B X X
Tin EPA 6010C X X
Tin EPA 6010D X X
Tin EPA 6020 X X
Tin EPA 6020A X X
Tin EPA 6020B X X
Titanium EPA 200.7 X X
Titanium EPA 200.8 X
Titanium EPA 6010B X X
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Titanium EPA 6010C X X
Titanium EPA 6010D X X
Titanium EPA 6020 X X
Titanium EPA 6020A X X
Titanium EPA 6020B X X
Tokuthion (Prothiophos)EPA 1657 X
Tokuthion (Prothiophos)EPA 8141A X X
Tokuthion (Prothiophos)EPA 8141B X X
Toluene EPA 602 X
Toluene EPA 624.1 X
Toluene EPA 8021B X X
Toluene EPA 8260B X X
Toluene EPA 8260C X X
Toluene EPA 8260D X X
Toluene EPA TO-15 X
Toluene IDNR OA-1 X X
Toluene LUFT GCMS X X
Toluene MADEP VPH X X
Toluene OK DEQ GRO X X
Toluene SM 6200 B-2011 X
Toluene EPA 524.2 X
Total coliforms SM 9223 B-2004 X X
Total Cyanide EPA 335.4 X
Total Cyanide EPA 9010B X
Total Cyanide EPA 9010C X X
Total Cyanide EPA 9012A X X
Total Cyanide EPA 9012B X X
Total Cyanide EPA 9014 X X
Total Cyanide
SM 4500-CN¯ B-
2011 X
Total Cyanide
SM 4500-CN¯ C-
2011 X
Total Cyanide
SM 4500-CN¯ E-
2011 X
Total Dissolved Solids SM 2540 C-2011 X
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Total Haloacetic Acids EPA 552.2 X
Total hardness as CaCO3 EPA 130.1 X
Total hardness as CaCO3 EPA 200.7 X
Total hardness as CaCO3 EPA 200.8 X
Total hardness as CaCO3 EPA 6010B X
Total hardness as CaCO3 EPA 6010C X X
Total hardness as CaCO3 EPA 6010D X
Total hardness as CaCO3 SM 2340 B-2011 X
Total hardness as CaCO3 SM 2340 C-2011 X
Total Nitrate+Nitrite EPA 300.0 X
Total Organic Carbon ASTM F1647-02A X
Total Organic Carbon EPA 9060 X
Total Organic Carbon EPA 9060A X
Total Organic Carbon SM 5310 B-2011 X X
Total Organic Carbon SM 5310 C-2011 X
Total Organic Carbon USDA LOI X
Total Organic Carbon
Walkley-Black
Method X
Total Organic Halides (TOX)EPA 9020B X
Total Organic Halides (TOX)EPA 9076 X
Total Organic Halides (TOX)SM 5320 B-2010 X
Total Petroleum Hydrocarbons
(>C12-C28)TNRCC 1005 X X
Total Petroleum Hydrocarbons
(>C28-C35)TNRCC 1005 X X
Total Petroleum Hydrocarbons
(Aviation Gasoline Range)EPA 8015B X X
Total Petroleum Hydrocarbons
(Aviation Gasoline Range)EPA 8015C X X
Total Petroleum Hydrocarbons
(Aviation Gasoline Range)EPA 8015D X X
Total Petroleum Hydrocarbons
(C6-C12)TNRCC 1005 X X
Total Petroleum Hydrocarbons
(C6-C35)TNRCC 1005 X X
Total Petroleum Hydrocarbons
(C8-C40)EPA 8015B X X
Total Petroleum Hydrocarbons
(C8-C40)EPA 8015C X X
Total Petroleum Hydrocarbons
(C8-C40)EPA 8015D X X
Total Petroleum Hydrocarbons
(Gasoline Range)TN GRO X
Total Petroleum Hydrocarbons
(Jet Fuel Range)EPA 8015B X X
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Total Petroleum Hydrocarbons
(Jet Fuel Range)EPA 8015C X X
Total Petroleum Hydrocarbons
(Jet Fuel Range)EPA 8015D X X
Total Petroleum Hydrocarbons
(Oil Range)EPA 8015B X X
Total Petroleum Hydrocarbons
(Oil Range)EPA 8015C X X
Total Petroleum Hydrocarbons
(Oil Range)EPA 8015D X X
Total Petroleum Hydrocarbons
(TPH)EPA 8015B X X
Total Petroleum Hydrocarbons
(TPH)EPA 8015C X X
Total Petroleum Hydrocarbons
(TPH)EPA 8015D X X
Total Petroleum Hydrocarbons
(TPH)FL PRO X
Total Petroleum Hydrocarbons
(TPH)TNRCC 1005 X X
Total Phenolics EPA 420.1 X X
Total Phenolics EPA 420.2 X
Total Phenolics EPA 420.4 X
Total Phenolics EPA 9066 X X
Total Phenolics SM 5530 D X
Total Phosphorus EPA 365.1 X
Total Phosphorus EPA 365.4 X X
Total Phosphorus EPA 6010B X
Total Phosphorus EPA 6010C X
Total Phosphorus EPA 6010D X
Total Phosphorus SM 4500-P B 5-2011 X
Total Phosphorus SM 4500-P H-2011 X
Total Purgeable Hydrocarbons
(C5-C12)MADEP VPH X X
Total radium EPA 903.0 (GPC) X X
Total radium EPA 9315 X X
Total radium SM 7500-Ra B (GPC) X
Total radium
SM 7500-Ra B
(GPC)-2001 X
Total residual chlorine SM 4500-Cl G-2011 X
Total Suspended Solids SM 2540 D-2011 X
Total Trihalomethanes EPA 524.2 X
Total, Fixed, and Volatile
Residue SM 2540 G X X
Total, Fixed, and Volatile
Residue SM 2540 G-2011 X
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Toxaphene (Chlorinated
camphene)EPA 608.3 X
Toxaphene (Chlorinated
camphene)EPA 8081A X X
Toxaphene (Chlorinated
camphene)EPA 8081B X X
Toxicity Characteristic Leaching
Procedure (TCLP)EPA 1311 X X
trans-1,2-Dichloroethene EPA 524.2 X
trans-1,2-Dichloroethylene EPA 624.1 X
trans-1,2-Dichloroethylene EPA 8260B X X
trans-1,2-Dichloroethylene EPA 8260C X X
trans-1,2-Dichloroethylene EPA 8260D X X
trans-1,2-Dichloroethylene EPA TO-15 X
trans-1,2-Dichloroethylene SM 6200 B-2011 X
trans-1,3-Dichloropropene EPA TO-15 X
trans-1,3-Dichloropropene EPA 524.2 X
trans-1,3-Dichloropropylene EPA 624.1 X
trans-1,3-Dichloropropylene EPA 8260B X X
trans-1,3-Dichloropropylene EPA 8260C X X
trans-1,3-Dichloropropylene EPA 8260D X X
trans-1,3-Dichloropropylene EPA TO-15 X
trans-1,3-Dichloropropylene
EPA TO-15 GC/MS
SIM X
trans-1,3-Dichloropropylene SM 6200 B-2011 X
trans-1,4-Dichloro-2-butene EPA 624.1 X
trans-1,4-Dichloro-2-butene EPA 8260B X X
trans-1,4-Dichloro-2-butene EPA 8260C X X
trans-1,4-Dichloro-2-butene EPA 8260D X X
trans-1,4-Dichloro-2-butene SM 6200 B-2011 X
trans-Diallate EPA 8270C X
trans-Isosafrole EPA 8270C X
Trichloroacetic acid EPA 552.2 X
Trichloroethene EPA 524.2 X
Trichloroethene
(Trichloroethylene)EPA 624.1 X
Trichloroethene
(Trichloroethylene)EPA 8260B X X
Trichloroethene
(Trichloroethylene)EPA 8260C X X
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Trichloroethene
(Trichloroethylene)EPA 8260D X X
Trichloroethene
(Trichloroethylene)EPA TO-15 X
Trichloroethene
(Trichloroethylene)SM 6200 B-2011 X
Trichlorofluoromethane EPA 524.2 X
Trichlorofluoromethane
(Fluorotrichloromethane, Freon
11)
EPA 624.1 X
Trichlorofluoromethane
(Fluorotrichloromethane, Freon
11)
EPA 8260B X X
Trichlorofluoromethane
(Fluorotrichloromethane, Freon
11)
EPA 8260C X X
Trichlorofluoromethane
(Fluorotrichloromethane, Freon
11)
EPA 8260D X X
Trichlorofluoromethane
(Fluorotrichloromethane, Freon
11)
EPA TO-15 X
Trichlorofluoromethane
(Fluorotrichloromethane, Freon
11)
SM 6200 B-2011 X
Trichloronate EPA 1657 X
Trichloronate EPA 8141A X X
Trichloronate EPA 8141B X X
Triclosan EPA 8270C X
Triclosan EPA 8270D X
Triclosan EPA 8270E X
tris-(2,3-Dibromopropyl)
phosphate (tris-BP)EPA 8270C X X
tris-(2,3-Dibromopropyl)
phosphate (tris-BP)EPA 8270D X X
tris-(2,3-Dibromopropyl)
phosphate (tris-BP)EPA 8270E X
Tritium EPA 906 X X
Tritium EPA 906 (Modified) X
Tritium EPA 906.0 X
Turbidity EPA 180.1 X X
Turbidity SM 2130 B-2011 X X
Ultrasonic Extraction EPA 3550B X
Ultrasonic Extraction EPA 3550C X
Uranium ASTM D5174-02 X X
Uranium
ASTM D5174-07
Modified (ENV-SOP-
MTJL-0337)
X X X
Uranium ASTM D5174-97 X X
Uranium DOE EML U-02-RC X
Uranium EPA 200.8 X X
Uranium EPA 6020 X X
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Uranium EPA 6020A X X
Uranium EPA 6020B X X
Uranium HASL 300 U-02-RC X
Uranium-234
ASTM D3972-09
Modified (ENV-SOP-
MTJL-0333)
X X X
Uranium-234 DOE EML U-02-RC X
Uranium-234 HASL 300 U-02-RC X
Uranium-235
ASTM D3972-09
Modified (ENV-SOP-
MTJL-0333)
X X X
Uranium-235 DOE EML U-02-RC X
Uranium-235 HASL 300 U-02-RC X
Uranium-238
ASTM D3972-09
Modified (ENV-SOP-
MTJL-0333)
X X X
Uranium-238 DOE EML U-02-RC X
Uranium-238 HASL 300 U-02-RC X
UV254 SM 5910 B-2011 X
Vanadium EPA 200.7 X X
Vanadium EPA 200.8 X X
Vanadium EPA 6010B X X
Vanadium EPA 6010C X X
Vanadium EPA 6010D X X
Vanadium EPA 6020 X X
Vanadium EPA 6020A X X
Vanadium EPA 6020B X X
Vinyl acetate EPA 624.1 X
Vinyl acetate EPA 8260B X X
Vinyl acetate EPA 8260C X X
Vinyl acetate EPA 8260D X X
Vinyl acetate EPA TO-15 X
Vinyl acetate SM 6200 B-2011 X
Vinyl bromide (Bromoethane)EPA 624.1 X
Vinyl bromide (Bromoethane)EPA 8260 X
Vinyl bromide (Bromoethane)EPA 8260B X X
Vinyl bromide (Bromoethane)EPA 8260C X X
Vinyl bromide (Bromoethane)EPA 8260D X X
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Vinyl bromide (Bromoethane)EPA TO-15 X
Vinyl bromide (Bromoethane)SM 6200 B-2011 X
Vinyl chloride EPA 624.1 X
Vinyl chloride EPA 8260B X X
Vinyl chloride EPA 8260C X X
Vinyl chloride EPA 8260D X X
Vinyl chloride EPA TO-15 X
Vinyl chloride
EPA TO-15 GC/MS
SIM X
Vinyl chloride SM 6200 B-2011 X
Vinyl chloride EPA 524.2 X
Volatile Petroleum
Hydrocarbons (VPH)
MADEP VPH
(modified) X
Volatile suspended solids SM 2540 E-2011 X
VPH Aliphatic >C6-C8 MADEP VPH X X
VPH Aliphatic >C8-C10 MADEP VPH X X
VPH Aliphatic C5-C8 MADEP VPH X X
VPH Aliphatic C5-C8
Unadjusted MADEP VPH X X
VPH Aliphatic C9-C12 MADEP VPH X X
VPH Aliphatic C9-C12
Unadjusted MADEP VPH X X
VPH Aromatic >C8-C10 MADEP VPH X X
VPH Aromatic C9-C10 MADEP EPH X
VPH Aromatic C9-C10 MADEP VPH X X
Waste Dilution EPA 3580A X X
Waste Dilution EPA 3585 X
Weak Acid Dissociable Cyanide SM 4500-CN I X
Xylene (mixed isomers, total)EPA 524.2 X
Xylene (total)EPA 602 X
Xylene (total)EPA 624.1 X
Xylene (total)EPA 8021B X X
Xylene (total)EPA 8260B X X
Xylene (total)EPA 8260C X X
Xylene (total)EPA 8260D X X
Xylene (total)EPA TO-15 X
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Xylene (total)IDNR OA-1 X X
Xylene (total)LUFT GCMS X X
Xylene (total)MADEP VPH X
Xylene (total)OK DEQ GRO X X
Xylene (total)SM 6200 B-2011 X
Zinc EPA 200.7 X X
Zinc EPA 200.8 X X
Zinc EPA 6010B X X
Zinc EPA 6010C X X
Zinc EPA 6010D X X
Zinc EPA 6020 X X
Zinc EPA 6020A X X
Zinc EPA 6020B X X
Zinc-65 DOE 4.5.2.3 X
Zinc-65 EPA 901.1 X
Zinc-65 HASL 300 Ga-01-R X
1 = Laboratory does not hold TNI Accreditation for this test method.
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7.3 Appendix C: Glossary
This glossary provides common terms and definitions used by PAS. It is not intended to be a
complete list of all terms and definitions used. The definitions have been compiled mostly from
the TNI Standard and DoD QSM. Although this information has been reproduced with care, errors
cannot be entirely excluded. Definitions for the same term also vary between sources. When the
meaning of a term used in a PAS document is different from this glossary or when the glossary does
not include the term, the term and definition is included or defined in context in the laboratory
document.
Term Definition
3P Program The continuous improvement program used by PAS that focuses on Process, Productivity, and
Performance.
Absence Inability to perform assigned duties due to lack of physical presence and connectivity.
Acceptance Criteria TNI- Specified limits placed on characteristics of an item, process, or service defined in requirement
documents.
Accreditation TNI- The process by which an agency or organization evaluates and recognizes a laboratory as meeting
certain predetermined qualifications or standards, thereby accrediting the laboratory.
DoD- Refers to accreditation in accordance with the DoD ELAP.
Accreditation Body (AB)TNI- The organization having responsibility and accountability for environmental laboratory
accreditation, and which grants accreditation under this program.
DoD- Entities recognized in accordance with the DoD-ELAP that are required to operate in accordance
with ISO/IEC 17011, Conformity assessment: General requirements for accreditation bodies accrediting conformity
assessment bodies. The AB must be a signatory, in good standing, to the International Laboratory
Accreditation Cooperation (ILAC) mutual recognition arrangement (MRA) that verifies, by evaluation
and peer assessment, that its signatory members are in full compliance with ISO/IEC 17011 and that its
accredited laboratories comply with ISO/IEC 17025.
Accuracy TNI- The degree of agreement between an observed value and an accepted reference value. Accuracy
includes a combination of random error (precision) and systematic error (bias) components that are due
to sampling and analytical operations; a data quality indicator.
Activity, Absolute TNI- Rate of nuclear decay occurring in a body of material, equal to the number of nuclear
disintegrations per unit time. NOTE: Activity (absolute) may be expressed in becquerels (Bq), curies (Ci),
or disintegrations per minute (dpm), and multiples or submultiples of these units.
Activity, Areic TNI- Quotient of the activity of a body of material and its associated area.
Activity, Massic TNI- Quotient of the activity of a body of material and its mass; also called specific activity.
Activity, Volumic TNI- Quotient of the activity of a body of material and its volume; also called activity concentration.
NOTE: In this module [TNI Volume 1, Module 6], unless otherwise stated, references to activity shall
include absolute activity, areic activity, massic activity, and volumic activity.
Activity Reference Date TNI- The date (and time, as appropriate to the half-life of the radionuclide) to which a reported activity
result is calculated. NOTE: The sample collection date is most frequently used as the Activity Reference
Date for environmental measurements, but different programs may specify other points in time for
correction of results for decay and ingrowth.
Aliquot DoD- A discrete, measured, representative portion of a sample taken for analysis.
American Society for
Testing and Materials
(ASTM)
An international standards organization that develops and publishes voluntary consensus standards for a
wide range of materials, products, systems, and services.
Analysis DoD- A combination of sample preparation and instrument determination.
Analysis Code (Acode)All the set parameters of a test, such as Analytes, Method, Detection Limits and Price.
Analysis Sequence A compilation of all samples, standards and quality control samples run during a specific amount of time
on a particular instrument in the order they are analyzed.
Analyst TNI- The designated individual who performs the “hands-on” analytical methods and associated
techniques and who is the one responsible for applying required laboratory practices and other pertinent
quality controls to meet the required level of quality.
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Analyte TNI- A substance, organism, physical parameter, property, or chemical constituent(s) for which an
environmental sample is being analyzed.
DoD- The specific chemicals or components for which a sample is analyzed; it may be a group of
chemicals that belong to the same chemical family and are analyzed together.
Analytical Method DoD- A formal process that identifies and quantifies the chemical components of interest (target
analytes) in a sample.
Analytical Uncertainty TNI- A subset of Measurement Uncertainty that includes all laboratory activities performed as part of the
analysis.
Aliquot DoD- A discrete, measured, representative portion of a sample taken for analysis.
Annual (or Annually)Defined by PAS as every 12 months ± 30 days.
Assessment TNI - The evaluation process used to measure or establish the performance, effectiveness, and
conformance of an organization and/or its system to defined criteria (to the standards and requirements
of laboratory accreditation).
DoD- An all-inclusive term used to denote any of the following: audit, performance evaluation, peer
review, inspection, or surveillance conducted on-site.
Atomic Absorption
Spectrometer
Instrument used to measure concentration in metals samples.
Atomization A process in which a sample is converted to free atoms.
Audit TNI- A systematic and independent examination of facilities, equipment, personnel, training, procedures,
record-keeping, data validation, data management, and reporting aspects of a system to determine
whether QA/QC and technical activities are being conducted as planned and whether these activities will
effectively achieve quality objectives.
Batch TNI- Environmental samples that are prepared and/or analyzed together with the same process and
personnel, using the same lot(s) of reagents. A preparation batch is composed of one to 20
environmental samples of the same quality systems matrix, meeting the above-mentioned criteria and
with a maximum time between the start of processing of the first and last sample in the batch to be 24
hours or the timeframe specified by the regulatory program. An analytical batch is composed of
prepared environmental samples (extracts, digestates or concentrates) which are analyzed together as a
group. An analytical batch can include prepared samples originating from various quality system matrices
and can exceed 20 samples.
Batch, Radiation
Measurements (RMB)
TNI- An RMB is composed of 1 to 20 environmental samples that are counted directly without
preliminary physical or chemical processing that affects the outcome of the test (e.g., non-destructive
gamma spectrometry, alpha/beta counting of air filters, or swipes on gas proportional detectors). The
samples in an RMB share similar physical and chemical parameter, and analytical configurations (e.g.,
analytes, geometry, calibration, and background corrections). The maximum time between the start of
processing of the first and last in an RMB is 14 calendar days.
Bias TNI- The systematic or persistent distortion of a measurement process, which causes errors in one
direction (i.e., the expected sample measurement is different from the sample’s true value).
Blank TNI and DoD- A sample that has not been exposed to the analyzed sample stream in order to monitor
contamination during sampling, transport, storage, or analysis. The blank is subjected to the usual
analytical and measurement process to establish a zero baseline or background value and is sometimes
used to adjust or correct routine analytical results (See Method Blank).
DoD- Blank samples are negative control samples, which typically include field blank samples (e.g., trip
blank, equipment (rinsate) blank, and temperature blank) and laboratory blank samples (e.g., method
blank, reagent blank, instrument blank, calibration blank, and storage blank).
Blind Sample A sub-sample for analysis with a composition known to the submitter. The analyst/laboratory may know
the identity of the sample but not its composition. It is used to test the analyst’s or laboratory’s
proficiency in the execution of the measurement process.
BNA (Base Neutral Acid
compounds)
A list of semi-volatile compounds typically analyzed by mass spectrometry methods. Named for the way
they can be extracted out of environmental samples in an acidic, basic, or neutral environment.
BOD (Biochemical
Oxygen Demand)
Chemical procedure for determining how fast biological organisms use up oxygen in a body of water.
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Calibration TNI- A set of operations that establish, under specified conditions, the relationship between values of
quantities indicated by a measuring instrument or measuring system, or values represented by a material
measure or a reference material, and the corresponding values realized by standards. 1) In calibration of
support equipment, the values realized by standards are established through the use of reference
standards that are traceable to the International System of Units (SI); 2) In calibration according to test
methods, the values realized by standards are typically established through the use of Reference Materials
that are either purchased by the laboratory with a certificate of analysis or purity, or prepared by the
laboratory using support equipment that has been calibrated or verified to meet specifications.
Calibration Curve TNI- The mathematical relationship between the known values, such as concentrations, of a series of
calibration standards and their instrument response.
Calibration Method A defined technical procedure for performing a calibration.
Calibration Range DoD- The range of values (concentrations) between the lowest and highest calibration standards of a
multi-level calibration curve. For metals analysis with a single-point calibration, the low-level calibration
check standard and the high standard establish the linear calibration range, which lies within the linear
dynamic range.
Calibration Standard TNI- A substance or reference material used for calibration.
Certified Reference
Material (CRM)
TNI- Reference material accompanied by a certificate, having a value, measurement uncertainty, and
stated metrological traceability chain to a national metrology institute.
Chain of Custody An unbroken trail of accountability that verifies the physical security of samples, data, and records.
Chain of Custody Form
(COC)
TNI- Record that documents the possession of the samples from the time of collection to receipt in the
laboratory. This record generally includes: the number and type of containers; the mode of collection, the
collector, time of collection; preservation; and requested analyses.
Chemical Oxygen
Demand (COD)
A test commonly used to indirectly measure the amount of organic compounds in water.
Client (referred to by
ISO as Customer)
Any individual or organization for whom items or services are furnished or work performed in response
to defined requirements and expectations.
Code of Federal
Regulations (CFR)
A codification of the general and permanent rules published in the Federal Register by agencies of the
federal government.
Comparability An assessment of the confidence with which one data set can be compared to another. Comparable data
are produced through the use of standardized procedures and techniques.
Completeness The percent of valid data obtained from a measurement system compared to the amount of valid data
expected under normal conditions. The equation for completeness is:
% Completeness = (Valid Data Points/Expected Data Points)*100
Confirmation TNI- Verification of the identity of a component through the use of an approach with a different
scientific principle from the original method. These may include but are not limited to second-column
confirmation; alternate wavelength; derivatization; mass spectral interpretation; alternative detectors; or
additional cleanup procedures.
DoD- Includes verification of the identity and quantity of the analyte being measured by another means
(e.g., by another determinative method, technology, or column). Additional cleanup procedures alone are
not considered confirmation techniques.
Conformance An affirmative indication or judgment that a product or service has met the requirements of the relevant
specifications, contract, or regulation; also, the state of meeting the requirements.
Congener A member of a class of related chemical compounds (e.g., PCBs, PCDDs).
Consensus Standard DoD- A standard established by a group representing a cross-section of a particular industry or trade, or a
part thereof.
Continuing Calibration
Blank (CCB)
A blank sample used to monitor the cleanliness of an analytical system at a frequency determined by the
analytical method.
Continuing Calibration
Check Compounds
(CCC)
Compounds listed in mass spectrometry methods that are used to evaluate an instrument calibration from
the standpoint of the integrity of the system. High variability would suggest leaks or active sites on the
instrument column.
Continuing Calibration
Verification
DoD- The verification of the initial calibration. Required prior to sample analysis and at periodic intervals.
Continuing calibration verification applies to both external and internal standard calibration techniques, as
well as to linear and non-linear calibration models.
Continuing Calibration
Verification (CCV)
Standard
Also referred to as a Calibration Verification Standard (CVS) in some methods, it is a standard used to
verify the initial calibration of compounds in an analytical method. CCVs are analyzed at a frequency
determined by the analytical method.
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Continuous Emission
Monitor (CEM)
A flue gas analyzer designed for fixed use in checking for environmental pollutants.
Continuous
Improvement Plan (CIP)
The delineation of tasks for a given laboratory department or committee to achieve the goals of that
department.
Contract Laboratory
Program (CLP)
A national network of EPA personnel, commercial labs, and support contractors whose fundamental
mission is to provide data of known and documented quality.
Contract Required
Detection Limit (CRDL)
Detection limit that is required for EPA Contract Laboratory Program (CLP) contracts.
Contract Required
Quantitation Limit
(CRQL)
Quantitation limit (reporting limit) that is required for EPA Contract Laboratory Program (CLP)
contracts.
Control Chart A graphic representation of a series of test results, together with limits within which results are expected
when the system is in a state of statistical control (see definition for Control Limit)
Control Limit A range within which specified measurement results must fall to verify that the analytical system is in
control. Control limit exceedances may require corrective action or require investigation and flagging of
non-conforming data.
Correction DoD- Action taken to eliminate a detected non-conformity.
Corrective Action DoD- The action taken to eliminate the causes of an existing non-conformity, defect, or other
undesirable situation in order to prevent recurrence. A root cause analysis may not be necessary in all
cases.
Corrective and
Preventative Action
(CAPA)
The primary management tools for bringing improvements to the quality system, to the management
of the quality system’s collective processes, and to the products or services delivered which are an
output of established systems and processes.
Critical Value TNI- Value to which a measurement result is compared to make a detection decision (also known as
critical level or decision level). NOTE: The Critical Value is designed to give a specified low probability α
of false detection in an analyte-free sample, which implies that a result that exceeds the Critical Value,
gives high confidence (1 – α) that the radionuclide is actually present in the material analyzed. For
radiometric methods, α is often set at 0.05.
Customer DoD- Any individual or organization for which products or services are furnished or work performed in
response to defined requirements and expectations.
Data Integrity TNI- The condition that exists when data are sound, correct, and complete, and accurately reflect
activities and requirements.
Data Quality Objective
(DQO)
Systematic strategic planning tool based on the scientific method that identifies and defines the type,
quality, and quantity of data needed to satisfy a specified use or end user.
Data Reduction TNI- The process of transforming the number of data items by arithmetic or statistical calculation,
standard curves, and concentration factors, and collating them into a more usable form.
Definitive Data DoD- Analytical data of known quantity and quality. The levels of data quality on precision and bias meet
the requirements for the decision to be made. Data that is suitable for final decision-making.
Demonstration of
Capability (DOC)
TNI- A procedure to establish the ability of the analyst to generate analytical results of acceptable
accuracy and precision.
DoD- A procedure to establish the ability of the analyst to generate analytical results by a specific method
that meet measurement quality objectives (e.g., for precision and bias).
Department of Defense
(DoD)
An executive branch department of the federal government of the United States charged with
coordinating and supervising all agencies and functions of the government concerned directly with
national security.
Detection Limit (DL)DoD- The smallest analyte concentration that can be demonstrated to be different than zero or a blank
concentration with 99% confidence. At the DL, the false positive rate (Type 1 error) is 1%. A DL may be
used as the lowest concentration for reliably reporting a detection of a specific analyte in a specific matrix
with a specific method with 99% confidence.
Detection Limit (DL) for
Safe Drinking Water Act
(SDWA) Compliance
TNI- Laboratories that analyze drinking-water samples for SDWA compliance monitoring must use
methods that provide sufficient detection capability to meet the detection limit requirements established
in 40 CFR 141. The SDWA DL for radioactivity is defined in 40 CFR Part 141.25.c as the radionuclide
concentration, which can be counted with a precision of plus or minus 100% at the 95% confidence level
(1.96σ where σ is the standard deviation of the net counting rate of the sample).
Deuterated Monitoring
Compounds (DMCs)
DoD- SIM specific surrogates as specified for GC/MS SIM analysis.
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Diesel Range Organics
(DRO)
A range of compounds that denote all the characteristic compounds that make up diesel fuel (range can
be state or program specific).
Digestion DoD- A process in which a sample is treated (usually in conjunction with heat and acid) to convert the
target analytes in the sample to a more easily measured form.
Document Control The act of ensuring that documents (and revisions thereto) are proposed, reviewed for accuracy,
approved for release by authorized personnel, distributed properly and controlled to ensure use of the
correct version at the location where the prescribed activity is performed.
Documents DoD- Written components of the laboratory management system (e.g., policies, procedures, and
instructions).
Dry Weight The weight after drying in an oven at a specified temperature.
Duplicate (also known as
Replicate or Laboratory
Duplicate)
The analyses or measurements of the variable of interest performed identically on two subsamples of the
same sample. The results of duplicate analyses are used to evaluate analytical or measurement precision
but not the precision of sampling, preservation, or storage internal to the laboratory.
Electron Capture
Detector (ECD)
Device used in GC methods to detect compounds that absorb electrons (e.g., PCB compounds).
Electronic Data
Deliverable (EDD)
A summary of environmental data (usually in spreadsheet form) which clients request for ease of data
review and comparison to historical results.
Eluent A solvent used to carry the components of a mixture through a stationary phase.
Elute To extract, specifically, to remove (absorbed material) from an absorbent by means of a solvent.
Elution A process in which solutes are washed through a stationary phase by movement of a mobile phase.
Environmental Data DoD- Any measurements or information that describe environmental processes, locations, or conditions;
ecological or health effects and consequences; or the performance of environmental technology.
Environmental
Monitoring
The process of measuring or collecting environmental data.
Environmental
Protection Agency
(EPA)
An agency of the federal government of the United States which was created for the purpose of
protecting human health and the environment by writing and enforcing regulations based on laws passed
by Congress.
Environmental Sample A representative sample of any material (aqueous, non-aqueous, or multimedia) collected from any source
for which determination of composition or contamination is requested or required. Environmental
samples can generally be classified as follows:
Non-Potable Water (Includes surface water, ground water, effluents, water treatment
chemicals, and TCLP leachates or other extracts)
Drinking Water - Delivered (treated or untreated) water designated as potable water
Water/Wastewater - Raw source waters for public drinking water supplies, ground waters,
municipal influents/effluents, and industrial influents/effluents
Sludge - Municipal sludges and industrial sludges.
Soil - Predominately inorganic matter ranging in classification from sands to clays.
Waste - Aqueous and non-aqueous liquid wastes, chemical solids, and industrial liquid and
solid wastes
Equipment Blank A sample of analyte-free media used to rinse common sampling equipment to check effectiveness of
decontamination procedures.
Extracted Internal
Standard Analyte
Isotopically labeled analogs of analytes of interest added to all standards, blanks and samples analyzed.
Added to samples and batch QC samples prior to the first step of sample extraction and to standards and
instrument blanks prior to analysis. Used for isotope dilution methods.
Facility A distinct location within the company that has unique certifications, personnel, and waste disposal
identifications.
False Negative DoD- A result that fails to identify (detect) an analyte or reporting an analyte to be present at or below a
level of interest when the analyte is actually above the level of interest.
False Positive DoD- A result that erroneously identifies (detects) an analyte or reporting an analyte to be present above
a level of interest when the analyte is actually present at or below the level of interest.
Field Blank A blank sample prepared in the field by filling a clean container with reagent water and appropriate
preservative, if any, for the specific sampling activity being undertaken.
Field Measurement Determination of physical, biological, or radiological properties, or chemical constituents that are
measured on-site, close in time and sPAS to the matrices being sampled/measured, following accepted
test methods. This testing is performed in the field outside of a fixed-laboratory or outside of an enclosed
structure that meets the requirements of a mobile laboratory.
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Field of Accreditation TNI- Those matrix, technology/method, and analyte combinations for which the accreditation body
offers accreditation.
Field of Proficiency
Testing (FoPT)
TNI- Matrix, technology/method, analyte combinations for which the composition, spike concentration
ranges and acceptance criteria have been established by the PTPEC.
Finding TNI- An assessment conclusion referenced to a laboratory accreditation standard and supported by
objective evidence that identifies a deviation from a laboratory accreditation standard requirement.
DoD- An assessment conclusion that identifies a condition having a significant effect on an item or
activity. An assessment finding may be positive, negative, or neutral and is normally accompanied by
specific examples of the observed condition. The finding must be linked to a specific requirement (e.g.,
this standard, ISO requirements, analytical methods, contract specifications, or laboratory management
systems requirements).
Flame Atomic
Absorption Spectrometer
(FAA)
Instrumentation used to measure the concentration of metals in an environmental sample based on the
fact that ground state metals absorb light at different wavelengths. Metals in a solution are converted to
the atomic state by use of a flame.
Flame Ionization
Detector (FID)
A type of gas detector used in GC analysis where samples are passed through a flame which ionizes the
sample so that various ions can be measured.
Gas Chromatography
(GC)
Instrumentation which utilizes a mobile carrier gas to deliver an environmental sample across a stationary
phase with the intent to separate compounds out and measure their retention times.
Gas Chromatograph/
Mass Spectrometry
(GC/MS)
In conjunction with a GC, this instrumentation utilizes a mass spectrometer which measures fragments of
compounds and determines their identity by their fragmentation patterns (mass spectra).
Gasoline Range Organics
(GRO)
A range of compounds that denote all the characteristic compounds that make up gasoline (range can be
state or program specific).
Graphite Furnace
Atomic Absorption
Spectrometry (GFAA)
Instrumentation used to measure the concentration of metals in an environmental sample based on the
absorption of light at different wavelengths that are characteristic of different analytes.
High Pressure Liquid
Chromatography
(HPLC)
Instrumentation used to separate, identify, and quantitate compounds based on retention times which are
dependent on interactions between a mobile phase and a stationary phase.
Holding Time TNI- The maximum time that can elapse between two specified activities.
40 CFR Part 136- The maximum time that samples may be held prior to preparation and/or analysis as
defined by the method and still be considered valid or not compromised.
For sample prep purposes, hold times are calculated using the time of the start of the preparation
procedure.
DoD- The maximum time that may elapse from the time of sampling to the time of preparation or
analysis, or from preparation to analysis, as appropriate.
Homogeneity The degree to which a property or substance is uniformly distributed throughout a sample.
Homologue One in a series of organic compounds in which each successive member has one more chemical group in
its molecule than the next preceding member. For instance, methanol, ethanol, propanol, butanol, etc.,
form a homologous series.
Improper Actions DoD- Intentional or unintentional deviations from contract-specified or method-specified analytical
practices that have not been authorized by the customer (e.g., DoD or DOE).
Incremental Sampling
Method (ISM)
Soil preparation for large volume (1 kg or greater) samples.
In-Depth Data
Monitoring
TNI- When used in the context of data integrity activities, a review and evaluation of documentation
related to all aspects of the data generation process that includes items such as preparation, equipment,
software, calculations, and quality controls. Such monitoring shall determine if the laboratory uses
appropriate data handling, data use and data reduction activities to support the laboratory’s data integrity
policies and procedures.
Inductively Coupled
Plasma Atomic Emission
Spectrometry (ICP-AES)
Analytical technique used for the detection of trace metals which uses plasma to produce excited atoms
that emit radiation of characteristic wavelengths.
Inductively Coupled
Plasma- Mass
Spectrometry (ICP/MS)
An ICP that is used in conjunction with a mass spectrometer so that the instrument is not only capable of
detecting trace amounts of metals and non-metals but is also capable of monitoring isotopic speciation
for the ions of choice.
Infrared Spectrometer
(IR)
An instrument that uses infrared light to identify compounds of interest.
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Initial Calibration (ICAL)The process of analyzing standards, prepared at specified concentrations, to define the quantitative
response relationship of the instrument to the analytes of interest. Initial calibration is performed
whenever the results of a calibration verification standard do not conform to the requirements of the
method in use or at a frequency specified in the method.
Initial Calibration Blank
(ICB)
A blank sample used to monitor the cleanliness of an analytical system at a frequency determined by the
analytical method. This blank is specifically run in conjunction with the Initial Calibration Verification
(ICV) where applicable.
Initial Calibration
Verification (ICV)
DoD- Verifies the initial calibration with a standard obtained or prepared from a source independent of
the source of the initial calibration standards to avoid potential bias of the initial calibration.
Injection Internal
Standard Analyte
Isotopically labeled analogs of analytes of interest (or similar in physiochemical properties to the target
analytes but with a distinct response) to be quantitated. Added to all blanks, standards, samples, and batch
QC after extraction and prior to analysis.
Instrument Blank A clean sample (e.g., distilled water) processed through the instrumental steps of the measurement
process; used to determine instrument contamination.
Instrument Detection
Limits (IDLs)
Limits determined by analyzing a series of reagent blank analyses to obtain a calculated concentration.
IDLs are determined by calculating the average of the standard deviations of three runs on three non-
consecutive days from the analysis of a reagent blank solution with seven consecutive measurements per
day.
Interference, spectral Occurs when particulate matter from the atomization scatters incident radiation from the source or when
the absorption or emission from an interfering species either overlaps or is so close to the analyte
wavelength that resolution becomes impossible.
Interference, chemical Results from the various chemical processes that occur during atomization and later the absorption
characteristics of the analyte.
Internal Standard TNI and DoD- A known amount of standard added to a test portion of a sample as a reference for
evaluating and controlling the precision and bias of the applied analytical method.
International
Organization for
Standardization (ISO)
An international standard-setting body composed of representatives from various national standards
organizations.
Intermediate Standard
Solution
Reference solutions prepared by dilution of the stock solutions with an appropriate solvent.
International System of
Units (SI)
The coherent system of units adopted and recommended by the General Conference on Weights and
Measures.
Ion Chromatography
(IC)
Instrumentation or process that allows the separation of ions and molecules based on the charge
properties of the molecules.
Isomer One of two or more compounds, radicals, or ions that contain the same number of atoms of the same
element but differ in structural arrangement and properties. For example, hexane (C6H14) could be n-
hexane, 2-methylpentane, 3-methylpentane, 2,3-dimethylbutane, 2,2-dimethylbutane.
Laboratory A body that calibrates and/or performs testing.
Laboratory Control
Sample (LCS)
TNI- (also known as laboratory fortified blank (LFB), spiked blank, or QC check sample): A sample
matrix, free from the analytes of interest, spiked with verified known amounts of analytes or a material
containing known and verified amounts of analytes and taken through all sample preparation and
analytical steps of the procedure unless otherwise noted in a reference method. It is generally used to
establish intra-laboratory or analyst-specific precision and bias or to evaluate the performance of all or a
portion of the measurement system.
Laboratory Duplicate Aliquots of a sample taken from the same container under laboratory conditions and processed and
analyzed independently.
Laboratory Information
Management System
(LIMS)
DoD- The entirety of an electronic data system (including hardware and software) that collects, analyzes,
stores, and archives electronic records and documents.
Learning Management
System (LMS)
A web-based database used by the laboratories to track and document training activities. The system is
administered by the corporate training department and each laboratory’s learn centers are maintained by a
local administrator.
Legal Chain-of-Custody
Protocols
TNI- Procedures employed to record the possession of samples from the time of sampling through the
retention time specified by the client or program. These procedures are performed at the special request
of the client and include the use of a Chain-of-Custody (COC) Form that documents the collection,
transport, and receipt of compliance samples by the laboratory. In addition, these protocols document all
handling of the samples within the laboratory.
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Limit(s) of Detection
(LOD)
TNI- The minimum result, which can be reliably discriminated from a blank with predetermined
confidence level.
DoD- The smallest concentration of a substance that must be present in a sample in order to be detected
at the DL with 99% confidence. At the LOD, the false negative rate (Type II error) is 1%. A LOD may
be used as the lowest concentration for reliably reporting a non-detect of a specific analyte in a specific
matrix with a specific method at 99% confidence.
Limit(s) of Quantitation
(LOQ)
TNI- The minimum levels, concentrations, or quantities of a target variable (e.g., target analyte) that can
be reported with a specified degree of confidence.
DoD- The smallest concentration that produces a quantitative result with known and recorded precision
and bias. For DoD/DOE projects, the LOQ shall be set at or above the concentration of the lowest
initial calibration standard and within the calibration range.
Linear Dynamic Range DoD- Concentration range where the instrument provides a linear response.
Liquid chromatography/
tandem mass
spectrometry
(LC/MS/MS)
Instrumentation that combines the physical separation techniques of liquid chromatography with the
mass analysis capabilities of mass spectrometry.
Lot TNI- A definite amount of material produced during a single manufacturing cycle and intended to have
uniform character and quality.
Management Those individuals directly responsible and accountable for planning, implementing, and assessing work.
Management System System to establish policy and objectives and to achieve those objectives.
Manager (however
named)
The individual designated as being responsible for the overall operation, all personnel, and the physical
plant of the environmental laboratory. A supervisor may report to the manager. In some cases, the
supervisor and the manager may be the same individual.
Matrix TNI- The substrate of a test sample.
Matrix Duplicate TNI- A replicate matrix prepared in the laboratory and analyzed to obtain a measure of precision.
Matrix Spike (MS)
(spiked sample or
fortified sample)
TNI- A sample prepared, taken through all sample preparation and analytical steps of the procedure
unless otherwise noted in a referenced method, by adding a known amount of target analyte to a specified
amount of sample for which an independent test result of target analyte concentration is available. Matrix
spikes are used, for example, to determine the effect of the matrix on a method’s recovery efficiency.
Matrix Spike Duplicate
(MSD) (spiked sample or
fortified sample
duplicate)
TNI- A replicate matrix spike prepared in the laboratory and analyzed to obtain a measure of the
precision of the recovery for each analyte.
Measurement
Performance Criteria
(MPC)
DoD- Criteria that may be general (such as completion of all tests) or specific (such as QC method
acceptance limits) that are used by a project to judge whether a laboratory can perform a specified activity
to the defined criteria.
Measurement Quality
Objective (MQO)
TNI- The analytical data requirements of the data quality objectives are project- or program-specific and
can be quantitative or qualitative. MQOs are measurement performance criteria or objectives of the
analytical process. Examples of quantitative MQOs include statements of required analyte detectability
and the uncertainty of the analytical protocol at a specified radionuclide activity, such as the action level.
Examples of qualitative MQOs include statements of the required specificity of the analytical protocol,
e.g., the ability to analyze for the radionuclide of interest given the presence of interferences.
Measurement System TNI- A method, as implemented at a particular laboratory, and which includes the equipment used to
perform the test and the operator(s).
DoD- A test method, as implemented at a particular laboratory, and which includes the equipment used
to perform the sample preparation and test and the operator(s).
Measurement
Uncertainty
DoD- An estimate of the error in a measurement often stated as a range of values that contain the true
value within a certain confidence level. The uncertainty generally includes many components which may
be evaluated from experimental standard deviations based on repeated observations or by standard
deviations evaluated from assumed probability distributions based on experience or other information.
For DoD/DOE, a laboratory’s Analytical Uncertainty (such as use of LCS control limits) can be reported
as the minimum uncertainty.
Method TNI- A body of procedures and techniques for performing an activity (e.g., sampling, chemical analysis,
quantification), systematically presented in the order in which they are to be executed.
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Method Blank TNI- A sample of a matrix similar to the batch of associated samples (when available) that is free from
the analytes of interest and is processed simultaneously with and under the same conditions as samples
through all steps of the analytical procedures, and in which no target analytes or interferences are present
at concentrations that impact the analytical results for sample analyses.
Method Detection Limit
(MDL)
TNI- One way to establish a Detection Limit; defined as the minimum concentration of a substance that
can be measured and reported with 99% confidence that the analyte concentration is greater than zero
and is determined from analysis of a sample in a given matrix containing the analyte.
Method of Standard
Additions
A set of procedures adding one or more increments of a standard solution to sample aliquots of the same
size in order to overcome inherent matrix effects. The procedures encompass the extrapolation back to
obtain the sample concentration.
Minimum Detectable
Activity (MDA)
TNI- Estimate of the smallest true activity that ensures a specified high confidence, 1 – β, of detection
above the Critical Value, and a low probability β of false negatives below the Critical Value. For
radiometric methods, β is often set at 0.05. NOTE 1: The MDS is a measure of the detection capability
of a measurement process and as such, it is an a priori concept. It may be used in the selection of
methods to meet specified MQOs. Laboratories may also calculate a “sample specific” MDA, which
indicates how well the measurement process is performing under varying real-world measurement
conditions, when sample-specific characteristics (e.g., interferences) may affect the detection capability.
However, the MDA must never be used instead of the Critical Value as a detection threshold. NOTE 2:
For the purpose of this Standard, the terms MDA and minimum detectable concentration (MDC) are
equivalent.
Minimum Reporting
Limit (MRL)
the lowest concentration of standard used for calibration – Drinking Water Manual
MintMiner Commercial software program used to scan large amounts of chromatographic data to monitor for errors
or data integrity issues.
Mobile Laboratory TNI- A portable enclosed structure with necessary and appropriate accommodation and environmental
conditions for a laboratory, within which testing is performed by analysts. Examples include but are not
limited to trailers, vans, and skid-mounted structures configured to house testing equipment and
personnel.
National Environmental
Laboratory Accreditation
Conference (NELAC)
See definition of The NELAC Institute (TNI).
National Institute of
Occupational Safety and
Health (NIOSH)
National institute charged with the provision of training, consultation, and information in the area of
occupational safety and health.
National Institute of
Standards and
Technology (NIST)
TNI- A federal agency of the US Department of Commerce’s Technology Administration that is
designed as the United States national metrology institute (or NMI).
National Pollutant
Discharge Elimination
System (NPDES)
A permit program that controls water pollution by regulating point sources that discharge pollutants into
U.S. waters.
Negative Control Measures taken to ensure that a test, its components, or the environment do not cause undesired effects,
or produce incorrect test results.
Nitrogen Phosphorus
Detector (NPD)
A detector used in GC analyses that utilizes thermal energy to ionize an analyte. With this detector,
nitrogen and phosphorus can be selectively detected with a higher sensitivity than carbon.
Nonconformance An indication or judgment that a product or service has not met the requirement of the relevant
specifications, contract, or regulation; also, the state of failing to meet the requirements.
Not Detected (ND)The result reported for a compound when the detected amount of that compound is less than the
method reporting limit.
Operator Aid DoD- A technical posting (such as poster, operating manual, or notepad) that assists workers in
performing routine tasks. All operator aids must be controlled documents (i.e., a part of the laboratory
management system).
Performance Based
Measurement System
(PBMS)
An analytical system wherein the data quality needs, mandates or limitations of a program or project are
specified and serve as criteria for selecting appropriate test methods to meet those needs in a cost-
effective manner.
Physical Parameter TNI- A measurement of a physical characteristic or property of a sample as distinguished from the
concentrations of chemical and biological components.
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Photo-ionization
Detector (PID)
An ion detector which uses high-energy photons, typically in the ultraviolet range, to break molecules into
positively charged ions.
Polychlorinated
Biphenyls (PCB)
A class of organic compounds that were used as coolants and insulating fluids for transformers and
capacitors. The production of these compounds was banned in the 1970’s due to their high toxicity.
Positive Control Measures taken to ensure that a test and/or its components are working properly and producing correct
or expected results from positive test subjects.
Post-Digestion Spike A sample prepared for metals analyses that has analytes spike added to determine if matrix effects may be
a factor in the results.
Power of Hydrogen (pH)The measure of acidity or alkalinity of a solution.
Practical Quantitation
Limit (PQL)
Another term for a method reporting limit. The lowest reportable concentration of a compound based
on parameters set up in an analytical method and the laboratory’s ability to reproduce those conditions.
Precision TNI- The degree to which a set of observations or measurements of the same property, obtained under
similar conditions, conform to themselves; a data quality indicator. Precision is usually expressed as
standard deviation, variance, or range, in either absolute or relative terms.
Preservation TNI and DoD- Any conditions under which a sample must be kept in order to maintain chemical,
physical, and/or biological integrity prior to analysis.
Primary Accreditation
Body (Primary AB)
TNI- The accreditation body responsible for assessing a laboratory’s total quality system, on-site
assessment, and PT performance tracking for fields of accreditation.
Procedure TNI- A specified way to carry out an activity or process. Procedures can be documented or not.
Proficiency Testing (PT)TNI- A means to evaluate a laboratory’s performance under controlled conditions relative to a given set
of criteria, through analysis of unknown samples provided by an external source.
Proficiency Testing
Program (PT Program)
TNI- The aggregate of providing rigorously controlled and standardized environmental samples to a
laboratory for analysis, reporting of results, statistical evaluation of the results and the collective
demographics and results summary of all participating laboratories.
Proficiency Testing
Provider (PT Provider)
TNI- A person or organization accredited by a TNI-approved Proficiency Testing Provider Accreditor to
operate a TNI-compliant PT Program.
Proficiency Testing
Provider Accreditor
(PTPA)
TNI- An organization that is approved by TNI to accredit and monitor the performance of proficiency
testing providers.
Proficiency Testing
Reporting Limit (PTRL)
TNI- A statistically derived value that represents the lowest acceptable concentration for an analyte in a
PT sample, if the analyte is spiked into the PT sample. The PTRLs are specified in the TNI FoPT tables.
Proficiency Testing
Sample (PT)
TNI- A sample, the composition of which is unknown to the laboratory, and is provided to test whether
the laboratory can produce analytical results within the specified acceptance criteria.
Proficiency Testing (PT)
Study
TNI- a) Scheduled PT Study: A single complete sequence of circulation and scoring of PT samples to all
participants in a PT program. The study must have the same pre-defined opening and closing dates for all
participants; b) Supplemental PT Study: A PT sample that may be from a lot previously released by a PT
Provider that meets the requirements for supplemental PT samples given in Volume 3 of this Standard
[TNI] but that does not have a pre-determined opening date and closing date.
Proficiency Testing Study
Closing Date
TNI- a) Scheduled PT Study: The calendar date by which all participating laboratories must submit
analytical results for a PT sample to a PT Provider; b) Supplemental PT Study: The calendar date a
laboratory submits the results for a PT sample to the PT Provider.
Proficiency Testing Study
Opening Date
TNI- a) Scheduled PT Study: The calendar date that a PT sample is first made available to all participants
of the study by a PT Provider; b) Supplemental PT Study: The calendar date the PT Provider ships the
sample to a laboratory.
Protocol TNI- A detailed written procedure for field and/or laboratory operation (e.g., sampling, analysis) that
must be strictly followed.
Qualitative Analysis DoD- Analysis designed to identify the components of a substance or mixture.
Quality Assurance (QA)TNI- An integrated system of management activities involving planning, implementation, assessment,
reporting and quality improvement to ensure that a process, item, or service is of the type and quality
needed and expected by the client.
Quality Assurance
Manual (QAM)
A document stating the management policies, objectives, principles, organizational structure and
authority, responsibilities, accountability, and implementation of an agency, organization, or laboratory, to
ensure the quality of its product and the utility of its product to its users.
Quality Assurance
Project Plan (QAPP)
A formal document describing the detailed quality control procedures by which the quality requirements
defined for the data and decisions pertaining to a specific project are to be achieved.
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Quality Control (QC)TNI- The overall system of technical activities that measures the attributes and performance of a process,
item, or service against defined standards to verify that they meet the stated requirements established by
the customer; operational techniques and activities that are used to fulfill requirements for quality; also the
system of activities and checks used to ensure that measurement systems are maintained within
prescribed limits, providing protection against “out of control” conditions and ensuring that the results
are of acceptable quality.
Quality Control Sample
(QCS)
TNI- A sample used to assess the performance of all or a portion of the measurement system. One of
any number of samples, such as Certified Reference Materials, a quality system matrix fortified by spiking,
or actual samples fortified by spiking, intended to demonstrate that a measurement system or activity is in
control.
Quality Manual TNI- A document stating the management policies, objectives, principles, organizational structure and
authority, responsibilities, accountability, and implementation of an agency, organization, or laboratory, to
ensure the quality of its product and the utility of its product to its users.
Quality System TNI and DoD- A structured and documented management system describing the policies, objectives,
principles, organizational authority, responsibilities, accountability, and implementation plan of an
organization for ensuring quality in its work processes, products (items), and services. The quality system
provides the framework for planning, implementing, and assessing work performed by the organization
and for carrying out required quality assurance and quality control activities.
Quality System Matrix TNI and DoD- These matrix definitions shall be used for purposes of batch and quality control
requirements and may be different from a field of accreditation matrix:
Air and Emissions: Whole gas or vapor samples including those contained in flexible or rigid
wall containers and the extracted concentrated analytes of interest from a gas or vapor that are
collected with a sorbant tube, impinger solution, filter, or other device
Aqueous: Any aqueous sample excluded from the definition of Drinking Water or
Saline/Estuarine. Includes surface water, groundwater effluents, and TCLP or other
extracts.
Biological Tissue: Any sample of a biological origin such as fish tissue, shellfish, or plant
material. Such samples shall be grouped according to origin.
Chemical Waste: A product or by-product of an industrial process that results in a matrix
not previously defined.
Drinking Water: Any aqueous sample that has been designated a potable or potentially
potable water source.
Non-aqueous liquid: Any organic liquid with <15% settleable solids
Saline/Estuarine: Any aqueous sample from an ocean or estuary, or other saltwater source
such as the Great Salt Lake.
Solids: Includes soils, sediments, sludges, and other matrices with >15% settleable solids.
Quantitation Range DoD- The range of values (concentrations) in a calibration curve between the LOQ and the highest
successively analyzed initial calibration standard used to relate instrument response to analyte
concentration. The quantitation range (adjusted for initial sample volume/weight, concentration/dilution,
and final volume) lies within the calibration range.
Quantitative Analysis DoD- Analysis designed to determine the amounts or proportions of the components of a substance.
Random Error The EPA has established that there is a 5% probability that the results obtained for any one analyte will
exceed the control limits established for the test due to random error. As the number of compounds
measured increases in a given sample, the probability for statistical error also increases.
Raw Data TNI- The documentation generated during sampling and analysis. This documentation includes, but is
not limited to, field notes, electronic data, magnetic tapes, untabulated sample results, QC sample results,
print outs of chromatograms, instrument outputs, and handwritten records.
Reagent Blank (method
reagent blank)
A sample consisting of reagent(s), without the target analyte or sample matrix, introduced into the
analytical procedure at the appropriate point and carried through all subsequent steps to determine the
contribution of the reagents and of the involved analytical steps.
Reagent Grade Analytical reagent (AR) grade, ACS reagent grade, and reagent grade are synonymous terms for reagents
that conform to the current specifications of the Committee on Analytical Reagents of the American
Chemical Society.
Records DoD- The output of implementing and following management system documents (e.g., test data in
electronic or hand-written forms, files, and logbooks).
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Reference Material TNI- Material or substance one or more of whose property values are sufficiently homogenized and well
established to be used for the calibration of an apparatus, the assessment of a measurement method, or
for assigning values to materials.
Reference Method TNI- A published method issued by an organization generally recognized as competent to do so. (When
the ISO language refers to a “standard method,” that term is equivalent to “reference method”). When a
laboratory is required to analyze by a specified method due to a regulatory requirement, the
analyte/method combination is recognized as a reference method. If there is no regulatory requirement
for the analyte/method combination, the analyte/method combination is recognized as a reference
method if it can be analyzed by another reference method of the same matrix and technology.
Reference Standard TNI- Standard used for the calibration of working measurement standards in a given organization or at a
given location.
Relative Percent
Difference (RPD)
A measure of precision defined as the difference between two measurements divided by the average
concentration of the two measurements.
Reporting Limit (RL)The level at which method, permit, regulatory and customer-specific objectives are met. The reporting
limit may never be lower than the Limit of Detection (i.e., statistically determined MDL). Reporting limits
are corrected for sample amounts, including the dry weight of solids, unless otherwise specified. There
must be a sufficient buffer between the Reporting Limit and the MDL.
DoD- A customer-specified lowest concentration value that meets project requirements for quantitative
data with known precision and bias for a specific analyte in a specific matrix.
Reporting Limit
Verification Standard
(RLVS)
A standard analyzed at the reporting limit for an analysis to verify the laboratory’s ability to report to that
level.
Representativeness A quality element related to the ability to collect a sample reflecting the characteristics of the part of the
environment to be assessed. Sample representativeness is dependent on the sampling techniques specified
in the project work plan.
Requirement Denotes a mandatory specification; often designated by the term “shall.”
Retention Time The time between sample injection and the appearance of a solute peak at the detector.
Revocation TNI- The total or partial withdrawal of a laboratory’s accreditation by an accreditation body.
Sample Portion of material collected for analysis, identified by a single, unique alphanumeric code. A sample may
consist of portions in multiple containers, if a single sample is submitted for multiple or repetitive
analysis.
Sample Condition Upon
Receipt Form (SCURF)
Form used by sample receiving personnel to document the condition of sample containers upon receipt
to the laboratory (used in conjunction with a COC).
Sample Delivery Group
(SDG)
A unit within a single project that is used to identify a group of samples for delivery. An SDG is a group
of 20 or fewer field samples within a project, received over a period of up to 14 calendar days. Data from
all samples in an SDG are reported concurrently.
Sample Receipt Form
(SRF)
Letter sent to the client upon login to show the tests requested and pricing.
Sample Tracking Procedures employed to record the possession of the samples from the time of sampling until analysis,
reporting and archiving. These procedures include the use of a chain-of-custody form that documents the
collection, transport, and receipt of compliance samples to the laboratory. In addition, access to the
laboratory is limited and controlled to protect the integrity of the samples.
Sampling TNI- Activity related to obtaining a representative sample of the object of conformity assessment,
according to a procedure.
Selected Ion Monitoring
(SIM)
A mode of analysis in mass spectrometry where the detector is set to scan over a very small mass range,
typically one mass unit. The narrower the range, the more sensitive the detector.
DoD- Using GC/MS, characteristic ions specific to target compounds are detected and used to quantify
in applications where the normal full scan mass spectrometry results in excessive noise.
Selectivity TNI- The ability to analyze, distinguish, and determine a specific analyte or parameter from another
component that may be a potential interferent or that may behave similarly to the target analyte or
parameter within the measurement system.
Sensitivity TNI- The capability of a method or instrument to discriminate between measurement responses
representing different levels (e.g., concentrations) of a variable of interest.
Serial Dilution The stepwise dilution of a substance in a solution.
Shall Denotes a requirement that is mandatory whenever the criterion for conformance with the specification
requires that there be no deviation. This does not prohibit the use of alternative approaches or methods
for implementing the specification as long as the requirement is fulfilled.
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Should Denotes a guideline or recommendation whenever noncompliance with the specification is permissible.
Signal-to-Noise Ratio
(S/N)
DoD- A measure of signal strength relative to background noise. The average strength of the noise of
most measurements is constant and independent of the magnitude of the signal. Thus, as the quantity
being measured (producing the signal) decreases in magnitude, S/N decreases and the effect of the noise
on the relative error of a measurement increases.
Source Water TNI- When sampled for drinking water compliance, untreated water from streams, rivers, lakes, or
underground aquifers, which is used to supply private and public drinking water supplies.
Spike A known mass of target analyte added to a blank sample or sub-sample; used to determine recovery
efficiency or for other quality control purposes.
Standard (Document)TNI- The document describing the elements of a laboratory accreditation that has been developed and
established within the consensus principles of standard setting and meets the approval requirements of
standard adoption organizations procedures and policies.
Standard (Chemical)Standard samples are comprised of a known amount of standard reference material in the matrix
undergoing analysis. A standard reference material is a certified reference material produced by US NIST
and characterized for absolute content, independent of analytical test method.
Standard Blank (or
Reagent Blank)
A calibration standard consisting of the same solvent/reagent matrix used to prepare the calibration
standards without the analytes. It is used to construct the calibration curve by establishing instrument
background.
Standard Method A test method issued by an organization generally recognized as competent to do so.
Standard Operating
Procedure (SOP)
TNI- A written document that details the method for an operation, analysis, or action with thoroughly
prescribed techniques and steps. SOPs are officially approved as the methods for performing certain
routine or repetitive tasks.
Standard Reference
Material (SRM)
A certified reference material produced by the US NIST or other equivalent organization and
characterized for absolute content, independent of analytical method.
Statement of
Qualifications (SOQ)
A document that lists information about a company, typically the qualifications of that company to
compete on a bid for services.
Stock Standard A concentrated reference solution containing one or more analytes prepared in the laboratory using
an assayed reference compound or purchased from a reputable commercial source.
Storage Blank DoD- A sample of analyte-free media prepared by the laboratory and retained in the sample storage area
of the laboratory. A storage blank is used to record contamination attributable to sample storage at the
laboratory.
Supervisor The individual(s) designated as being responsible for a particular area or category of scientific analysis.
This responsibility includes direct day-to-day supervision of technical employees, supply and instrument
adequacy and upkeep, quality assurance/quality control duties and ascertaining technical employees have
the required balance of education, training, and experience to perform the required analyses.
Surrogate DoD- A substance with properties that mimic the analyte of interest. It is unlikely to be found in
environmental samples and is added to them for quality control purposes.
Suspension TNI- The temporary removal of a laboratory’s accreditation for a defined period of time, which shall not
exceed 6 months or the period of accreditation, whichever is longer, in order to allow the laboratory time
to correct deficiencies or area of non-conformance with the Standard.
Systems Audit An on-site inspection or assessment of a laboratory’s quality system.
Target Analytes DoD- Analytes or chemicals of primary concern identified by the customer on a project-specific basis.
Technical Director Individual(s) who has overall responsibility for the technical operation of the environmental testing
laboratory.
Technology TNI- A specific arrangement of analytical instruments, detection systems, and/or preparation techniques.
Test A technical operation that consists of the determination of one or more characteristics or performance of
a given product, material, equipment, organism, physical phenomenon, process, or service according to a
specified procedure. The result of a test is normally recorded in a document sometimes called a test
report or a test certificate.
Test Method DoD- A definitive procedure that determines one or more characteristics of a given substance or
product.
Test Methods for
Evaluating Solid Waste,
Physical/ Chemical (SW-
846)
EPA Waste’s official compendium of analytical and sampling methods that have been evaluated and
approved for use in complying with RCRA regulations.
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Test Source TNI- A radioactive source that is tested, such as a sample, calibration standard, or performance check
source. A Test Source may also be free of radioactivity, such as a Test Source counted to determine the
subtraction background, or a short-term background check.
The NELAC Institute
(TNI)
A non-profit organization whose mission is to foster the generation of environmental data of known and
documented quality through an open, inclusive, and transparent process that is responsive to the needs of
the community. Previously known as NELAC (National Environmental Laboratory Accreditation
Conference).
Total Petroleum
Hydrocarbons (TPH)
A term used to denote a large family of several hundred chemical compounds that originate from crude
oil. Compounds may include gasoline components, jet fuel, volatile organics, etc.
Toxicity Characteristic
Leaching Procedure
(TCLP)
A solid sample extraction method for chemical analysis employed as an analytical method to simulate
leaching of compounds through a landfill.
Traceability TNI- The ability to trace the history, application, or location of an entity by means of recorded
identifications. In a calibration sense, traceability relates measuring equipment to national or international
standards, primary standards, basic physical conditions or properties, or reference materials. In a data
collection sense, it relates calculations and data generated throughout the project back to the requirements
for the quality of the project.
Training Document A training resource that provides detailed instructions to execute a specific method or job function.
Trip Blank This blank sample is used to detect sample contamination from the container and preservative during
transport and storage of the sample. A cleaned sample container is filled with laboratory reagent water
and the blank is stored, shipped, and analyzed with its associated samples.
Tuning A check and/or adjustment of instrument performance for mass spectrometry as required by the
method.
Ultraviolet
Spectrophotometer (UV)
Instrument routinely used in quantitative determination of solutions of transition metal ions and highly
conjugated organic compounds.
Uncertainty, Counting TNI- The component of Measurement Uncertainty attributable to the random nature of radioactive
decay and radiation counting (often estimated as the square root of observed counts (MARLAP). Older
references sometimes refer to this parameter as Error, Counting Error, or Count Error (c.f., Total
Uncertainty).
Uncertainty, Expanded TNI- The product of the Standard Uncertainty and a coverage factor, k, which is chosen to produce an
interval about the result that has a high probability of containing the value of the measurand (c.f.,
Standard Uncertainty). NOTE: Radiochemical results are generally reported in association with the Total
Uncertainty. Either if these estimates of uncertainty can be reported as the Standard Uncertainty (one-
sigma) or as an Expanded Uncertainty (k-sigma, where k > 1).
Uncertainty,
Measurement
TNI- Parameter associated with the result of a measurement that characterizes the dispersion of the
values that could reasonably be attributed to the measurand.
Uncertainty, Standard TNI- An estimate of the Measurement Uncertainty expressed as a standard deviation (c.f., Expanded
Uncertainty).
Uncertainty, Total TNI- An estimate of the Measurement Uncertainty that accounts for contributions from all significant
sources of uncertainty associated with the analytical preparation and measurement of a sample. Such
estimates are also commonly referred to as Combined Standard Uncertainty or Total Propagated
Uncertainty, and in some older references as the Total Propagated Error, among other similar items (c.f.,
Counting Uncertainty).
Unethical actions DoD- Deliberate falsification of analytical or quality control results where failed method or contractual
requirements are made to appear acceptable.
United States
Department of
Agriculture (USDA)
A department of the federal government that provides leadership on food, agriculture, natural resources,
rural development, nutrition, and related issues based on public policy, the best available science, and
effective management.
United States Geological
Survey (USGS)
Program of the federal government that develops new methods and tools to supply timely, relevant, and
useful information about the Earth and its processes.
Unregulated
Contaminant Monitoring
Rule (UCMR)
EPA program to monitor unregulated contaminants in drinking water.
Validation DoD- The confirmation by examination and provision of objective evidence that the particular
requirements for a specific intended use are fulfilled.
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Verification TNI- Confirmation by examination and objective evidence that specified requirements have been met. In
connection with the management of measuring equipment, verification provides a means for checking
that the deviations between values indicated by a measuring instrument and corresponding known values
of a measured quantity are consistently smaller than the maximum allowable error defined in a standard,
regulation, or specification peculiar to the management of the measuring equipment.
Voluntary Action
Program (VAP)
A program of the Ohio EPA that gives individuals a way to investigate possible environmental
contamination, clean it up if necessary and receive a promise from the State of Ohio that no more
cleanup is needed.
Whole Effluent Toxicity
(WET)
The aggregate toxic effect to aquatic organisms from all pollutants contained in a facility’s wastewater
(effluent).
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7.4 Appendix D: Organization Chart(s)
7.4.1 PAS Corporate Organization Chart(s)
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7.4.2 PAS Quality Systems Management Organization Chart
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7.4.3 Mt. Juliet – Organization Chart
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7.5 Appendix E: Equipment Listing
The equipment listed represents equipment were held by each location on the effective date of this
manual. This information is subject to change without notice. External parties should contact the
location for the most current information.
7.5.1 PAS-Mt. Juliet
Equipment List: PAS-Mt. Juliet
Description Manufacturer Model Serial Number Service
Date
Condition Location Internal
ID
Manual
Location
GC/FID Agilent 6890N US10137006 As
Needed
Used Air Lab AIRGC2 Online
GC/FID Agilent 6890N US10137006 As
Needed
Used Air Lab AIRGC2 Online
Gas
Chromatograph
HP 6890N TCD US10726007 As
Needed
Used Air Lab AIRGC3 Online
GC/FID Agilent 7890B CN14513033 As
Needed
Used Air Lab AIRGC4 Online
Gas
Chromatograph/
Mass
Spectrometer
Agilent 7890A/5975 CN13231014
US50680012
As
Needed
Used Air Lab AIRMS1 Online
Preconcentrator Entech 7200 1683 As
Needed
Used Air Lab AIRMS1 Online
Canister
Autosampler
Entech 7016D 1708 As
Needed
Used Air Lab AIRMS1 Online
Gas
Chromatograph/
Mass
Spectrometer
Agilent 6890N/5975 CN10551083
US61332744
As
Needed
Used Air Lab AIRMS2 Online
Preconcentrator Entech 7200 1005 As
Needed
Used Air Lab AIRMS2 Online
Tedlar
Autosampler
Entech 7032A 1017 As
Needed
Used Air Lab AIRMS2 Online
Canister
Autosampler
Entech 7016D 1871 As
Needed
Used Air Lab AIRMS2 Online
Gas
Chromatograph
Agilent 6890 US000011333 As
Needed
Used Air Lab AIRMS3 Online
Injector Agilent G2614A CN40327743 As
Needed
Used Air Lab AIRMS3 Online
Gas
Chromatograph/
Mass
Spectrometer
Agilent 6890/5973 US00024695
US82311265
As
Needed
Used Air Lab AIRMS4 Online
Preconcentrator Entech 7200 1174 As
Needed
USED Air Lab AIRMS4 Online
Canister
Autosampler
Entech 7016D 1870 As
Needed
Used Air Lab AIRMS4 Online
Gas
Chromatograph/
Mass
Spectrometer
Agilent 6890/5973 GCUS00039611
MSUS0340681
As
Needed
Used Air Lab AIRMS5 Online
Preconcentrator Entech 7200 1162 As
Needed
Used Air Lab AIRMS5 Online
Canister
Autosampler
Entech 7016D 1741 As
Needed
Used Air Lab AIRMS5 Online
Tedlar
Autosampler
Entech 7032AB 1044 As
Needed
Used Air Lab AIRMS5 Online
Gas
Chromatograph/
Mass
Spectrometer
Agilent 7890A/5975C GCUS10831022
MSU91732329
As
Needed
Used Air Lab AIRMS6 Online
Draft
ENV-MAN-MTJL-0001 v03_Quality Manual
Effective Date: 8/15/2022 3:09:53 PM
COPYRIGHT © 2019-2022 Pace® Analytical Services, LLC.
Description Manufacturer Model Serial Number Service
Date
Condition Location Internal
ID
Manual
Location
Canister
Autosampler
Entech 7016D 1505 As
Needed
Used Air Lab AIRMS6 Online
Preconcentrator Entech 7200 1322 As
Needed
Used Air Lab AIRMS6 Online
Gas
Chromatograph/
Mass
Spectrometer
Agilent 6890/5975C US00024616
US71236615
As
Needed
Used Air Lab AIRMS7 Online
Preconcentrator Entech 7200 1720 As
Needed
Used Air Lab AIRMS7 Online
Canister
Autosampler
Entech 7016D 1991 As
Needed
Used Air Lab AIRMS7 Online
Gas
Chromatograph/
Mass
Spectrometer
Agilent 8890/5977B US2008A003
US2007M007
As
Needed
Used Air Lab AIRMS8 Online
Preconcentrator Entech 7200A 00118 As
Needed
Used Air Lab AIRMS8 Online
Canister
Autosampler
Entech 7016D 1869 As
Needed
Used Air Lab AIRMS8 Online
Canister
Autosampler
Entech 7016D 1828 As
Needed
Used Air Lab AIRMS8 Online
Gas
Chromatograph/
Mass
Spectrometer
Agilent 8890/5977B US2007A038
US2006M061
As
Needed
Used Air Lab AIRMS9 Online
Preconcentrator Entech 7200A 00117 As
Needed
Used Air Lab AIRMS9 Online
Canister
Autosampler
Entech 7016D 1872 As
Needed
Used Air Lab AIRMS9 Online
Canister
Autosampler
Entech 7016D 1990 As
Needed
Used Air Lab AIRMS9 Online
Gas
Chromatograph/
Mass
Spectrometer
Agilent 8890/5977B US2209A075
US2201R007
As
Needed
Used Air Lab AIRMS10 Online
Preconcentrator Entech 7200A 00145 As
Needed
Used Air Lab AIRMS10 Online
Canister
Autosampler
Entech 7016D 2000 As
Needed
Used Air Lab AIRMS10 Online
Gas
Chromatograph/
Mass
Spectrometer
Agilent 8890/5977B US2209A079
US2202R013
As
Needed
Used Air Lab AIRMS11 Online
Preconcentrator Entech 7200A 00146 As
Needed
Used Air Lab AIRMS11 Online
Canister
Autosampler
Entech 7016D 2001 As
Needed
Used Air Lab AIRMS11 Online
Canister
Autosampler
Entech 7016D 2002 As
Needed
Used Air Lab AIRMS11 Online
Canister
Autosampler
Entech 7650-01 0130 As
Needed
Used Air Lab AIRMS11 Online
Precision Diluter Entech 4700 0371 As
Needed
Used Air Lab Online
Dynamic Diluter Entech Model 4600A 1086 As
Needed
Used Air Lab Online
TO Canister Restek/Entec
h
TO-
CAN/SiloniteCan
N/A As
Needed
Used Air Lab 3024 cans
owned
Online
Passive Sampling
Kit
Restek/Entec
h
N/A As
Needed
Used Air Lab 2218
owned
Online
Field hand held
PID
RAE Systems MiniRAE3000 592-929317 As
Needed
Used Air Lab Online
Canister Cleaner Entech 3100A 1178 As
Needed
Used Air Lab Oven 1 Online
Draft
ENV-MAN-MTJL-0001 v03_Quality Manual
Effective Date: 8/15/2022 3:09:53 PM
COPYRIGHT © 2019-2022 Pace® Analytical Services, LLC.
Description Manufacturer Model Serial Number Service
Date
Condition Location Internal
ID
Manual
Location
Oven Entech 3513ENT 1482050570384 As
Needed
Used Air Lab Oven 1 Online
Oven Entech 3513ENT 1482060344515 As
Needed
Used Air Lab Oven 1 Online
Canister Cleaner Entech 3100A 1473 As
Needed
Used Air Lab Oven 2 Online
Oven Entech 3513ENT 1482060344518 As
Needed
Used Air Lab Oven 2 Online
Oven Entech 31-350ER B33ER-01180 As
Needed
Used Air Lab Oven 2 Online
Canister Cleaner Entech 3100A 1448 As
Needed
Used Air Lab Oven 3 Online
Oven Entech 31-350 B33-02663 As
Needed
Used Air Lab Oven 3 Online
Oven Entech 31-350ER B33ER-01142 As
Needed
Used Air Lab Oven 3 Online
Canister Cleaner Entech 3100D 1741 As
Needed
Used Air Lab Oven 4 Online
Oven Entech 31-350ER B33ER-01654 As
Needed
Used Air Lab Oven 4 Online
Oven Entech 31-350ER B33ER-01652 As
Needed
Used Air Lab Oven 4 Online
Canister Cleaner Entech 3100D 2214 As
Needed
Used Air Lab Oven 5 Online
Oven Entech 09-OV6L8 0134 As
Needed
Used Air Lab Oven 5 Online
Oven Entech 09-OV6L8 0135 As
Needed
Used Air Lab Oven 5 Online
Canister Cleaner Entech 3100A 1154 As
Needed
Used Air Lab Oven 6 Online
Oven Entech 3513ENT 1482060344516 As
Needed
Used Air Lab Oven 6 Online
Oven Entech 3513ENT 1003-4123 As
Needed
Used Air Lab Oven 6 Online
Canister Cleaner Entech 3100D 1154 As
Needed
Used Air Lab Oven 7 Online
Oven Entech 09-OV6L12 0212 As
Needed
Used Air Lab Oven 7 Online
Oven Entech 09-OV6L12 0213 As
Needed
Used Air Lab Oven 7 Online
Description Manufacturer Model Serial Number Service
Date
Condition Location Internal
ID
Manual
Location
Analytical
Balance
Mettler XSE 105 Dual
Range
B634906554 Annual Used Aquatic
Tox Lab
002929 Biomon
Class “I” weights
(2)
Troemner SN #67812 67812 Annual Used Aquatic
Tox Lab
000565 UKN
Stereoscope Olympus SZX2-ILLD 7D48897 Annual Used Aquatic
Tox Lab
N/A Biomon
Oven (2)Fisher 655F 30400142 Annual Used Aquatic
Tox Lab
304 UKN
Cold Room Thermo-Kool Walk-In
Refrigerator
49409 Annual Used Aquatic
Tox Lab
1800 UKN
Stir plate Fisher 170 US HHKF65010 Annual Used Aquatic
Tox Lab
N/A Biomon
Stir plate Fisher 120 US HBKF63004 Annual Used Aquatic
Tox Lab
N/A Biomon
Stir plate VWR 151211003 Annual Used Aquatic
Tox Lab
N/A Biomon
Stir plate VWR 97042-626 151211016 Annual Used Aquatic
Tox Lab
N/A Biomon
Draft
ENV-MAN-MTJL-0001 v03_Quality Manual
Effective Date: 8/15/2022 3:09:53 PM
COPYRIGHT © 2019-2022 Pace® Analytical Services, LLC.
Description Manufacturer Model Serial Number Service
Date
Condition Location Internal
ID
Manual
Location
Chlorine meter Hach DR300 19110A002361 Annual Used Aquatic
Tox Lab
P0148 Biomon
Hardness meter Orbeco-
Hellige
942 2444 Annual Used Aquatic
Tox Lab
N/A Biomon
Conductivity
Probe
ZW1-10283 ZW1-10283 Annual Used Aquatic
Tox Lab
N/A Biomon
Hood 4 Labconco 6963401 111151057 12-1-21 Used Micro 2329 Biomon
pH probe Thermo
Scientific
ZY1-18044 ZY1-18044 Annual Used Aquatic
Tox Lab
N/A Biomon
Incubator-I9 Thermo
Scientific
Precision
Annual Used Aquatic
Tox Lab
2355 Biomon
Incubator I8 Thermo
Scientific
Precision
MH400-S 42499233 Annual Used Aquatic
Tox Lab
N/A Biomon
Incubator-I4 Thermo
Scientific
Precision
02010320 Annual Used Aquatic
Tox Lab
N/A Biomon
Stereoscope Olympus SZX2-ILLD
(ESCP0004)
7B49859 Annual Used Aquatic
Tox Lab
P0004 Biomon
pH meter Orion VersaStar X61072 Annual Used Aquatic
Tox Lab
X61072 Biomon
Waterbath 1 Lindberg/Bl
ue
WB1130A X05R-220204-
XE
Annual UKN Aquatic
Tox Lab
000601 N/A
Stereoscope Olympus SZH-ILLD
(ESC125)
711005 Annual Used Aquatic
Tox Lab
N/A Biomon
Stereoscope Olympus SZXz-ILLD 9B49874 Annual Used Aquatic
Tox Lab
Biomon
Waterbath Thermo
Scientific
C1R89 300253242 Annual Used Aquatic
Tox Lab
P0131 UKN
Refrigerator True 63366 909935 Annual UKN Aquatic
Tox Lab
UKN
Water Purifier ELGA Pure
Lab
4LXXXSCM2 ULT00002887 N/A Used Aquatic
Tox Lab
2628 Biomon
Mini fridge Haier HC27SG42RG BS0882E1G00B
KFCH0426
Annual Used Aquatic
Tox Lab
n/A N/A
RDO Probe Thermo
Scientific
Orion
VSTAR-RD 15762 Daily Used Aquatic
Tox Lab
N/A Biomon
Oven (1)Thermoscient
ific
Heratherm
OGS400
41831936 Annual New Aquatic
Tox Lab
2809 Biomon
Freezer Kenmore 198.8130582 P20949206 Annual Used Aquatic
Tox Lab
N/A UKN
Incubator Crown Tonka Walk-In 260333-01 J01 Annual New Aquatic
Tox Lab
N/A Biomon
Description Manufacturer Model Serial
Number
Service Date Condition Location Internal
ID
Manual
Location
Balance - Top
Loading
Mettler
Toledo
PB3002-S 1121462199 See
KanbanFlo
w
Used Metals
Prep
METBAL3 Supervisor's
Office
Balance - Top
Loading
Mettler
Toledo
PB3002-S 1119070828 See
KanbanFlo
w
Used Metals
Prep
METBAL2 Supervisor's
Office
Balance - Top
Loading
Torbal AGN100 701001026 See
KanbanFlo
w
Used Metals
Prep
METBAL5 Supervisor's
Office
Balance - Top
Loading
Mettler
Toledo
PB3002-S 1128150150 See
KanbanFlo
w
Used TCLP METBAL1 Supervisor's
Office
Draft
ENV-MAN-MTJL-0001 v03_Quality Manual
Effective Date: 8/15/2022 3:09:53 PM
COPYRIGHT © 2019-2022 Pace® Analytical Services, LLC.
Description Manufacturer Model Serial
Number
Service Date Condition Location Internal
ID
Manual
Location
Balance - Top
Loading
Mettler
Toledo
XSR1202S C20129128 See
KanbanFlo
w
Used TCLP TCLPBAL
2
Supervisor's
Office
Balance - Top
Loading
Mettler
Toledo
XS40025 B712847753 See
KanbanFlo
w
Used TCLP METBAL4 Supervisor's
Office
Balance - Top
Loading
Mettler
Toledo
XS40025 B410367932 See
KanbanFlo
w
Used Mercury HGBAL1 Supervisor's
Office
Hotblock Environment
al Express
SC154 9062CECW39
53
See
KanbanFlo
w
Used Metals
Prep
MPE Supervisor's
Office
Hotblock Environment
al Express
SC154 2015CECW42
78
See
KanbanFlo
w
Used Metals
Prep
MPF Supervisor's
Office
Hotblock Environment
al Express
SC154 2015CECW43
38
See
KanbanFlo
w
Used Metals
Prep
MPG Supervisor's
Office
Hotblock Environment
al Express
SC154 2018CECW49
65
See
KanbanFlo
w
Used Metals
Prep
MPO Supervisor’s
Office
Hotblock Environment
al Express
SC154 9062CECW39
54
See
KanbanFlo
w
Used Mercury HG1 Supervisor's
Office
Hotblock Environment
al Express
SC154 9062CECW39
56
See
KanbanFlo
w
Used Mercury HG2 Supervisor's
Office
Hotblock Environment
al Express
SC154 3994CEC1880 See
KanbanFlo
w
Used Mercury MPC Supervisor's
Office
Hotblock Environment
al Express
SC154 missing See
KanbanFlo
w
Used Mercury MPD Supervisor's
Office
Hotblock Environment
al Express
SC154 See Kanban
Flow
Used Mercury MPN Supervisor’s
Office
Microwave CEM Mars 5 Xpress MD7441 See
KanbanFlo
w
Used Metals
Prep
MD7441 Supervisor's
Office
Microwave CEM Mars 5 Xpress MD4692 See
KanbanFlo
w
Used Metals
Prep
MD4692 Supervisor's
Office
Microwave CEM Mars 6 MJ2771 See
KanbanFlo
w
Used Metals
Prep
MJ2771 Supervisor's
Office
Microwave CEM Mars 6 MJ9747 See
KanbanFlo
w
Used Metals
Prep
MJ9747 Supervisor's
Office
Microwave CEM Mars 6 MJ9726 See
KanbanFlo
w
Used Metals
Prep
MJ9726 Supervisor's
Office
Centrifuge Thermo
Fisher
Sorvall ST 40 42496720 See
KanbanFlo
w
Used Metals
Prep
N/A Supervisor's
Office
Turbidimeter Hach TL2300 2019060C0080 See
KanbanFlo
w
Used Metals
Prep
N/A Supervisor's
Office
Turbidimeter HACH 2100N 2020060C0093 See
KanbanFlo
w
Used Metals
Prep
N/A Supervisor’s
Office
Water Purifier ELGA Purelab Ultra ULT00002665 See
KanbanFlo
w
Used Metals
Prep
N/A Supervisor's
Office
Mercury Analyzer Leeman Hydra II AA 4049 See
KanbanFlo
w
Used Mercury CVAA 5 Supervisor's
Office
Draft
ENV-MAN-MTJL-0001 v03_Quality Manual
Effective Date: 8/15/2022 3:09:53 PM
COPYRIGHT © 2019-2022 Pace® Analytical Services, LLC.
Description Manufacturer Model Serial
Number
Service Date Condition Location Internal
ID
Manual
Location
Mercury Analyzer Teledyne QuickTrace 7600 US17016008 See
KanbanFlo
w
Used Mercury CVAA 6 Supervisor's
Office
Mercury Analyzer PerkinElmer FIMS 100 101S18111401 See
KanbanFlo
w
Used Mercury CVAA 7 Supervisor's
Office
ICP OES Thermo ICAP 7400 Duo IC74DC14180
1
See
KanbanFlo
w
Used ICP ICP 12 Supervisor's
Office
ICP OES Thermo ICAP 7400 Duo IC74DC14380
4
See
KanbanFlo
w
Used ICP ICP 13 Supervisor's
Office
ICP OES Thermo ICAP 7400 Duo IC74DC15110
3
See
KanbanFlo
w
Used ICP ICP 14 Supervisor's
Office
ICP OES Thermo ICAP 6500 DUO ICP-20074614 Used Metals
Lab
ICP15 Supervisor’s
Office
ICPMS Agilent 7900 G8403A JP16281469 See
KanbanFlo
w
Used ICPMS ICPMS 8 Supervisor's
Office
ICPMS Agilent (1) 7900
G8403A
JP14400452 See
KanbanFlo
w
Used ICPMS ICPMS 9 Supervisor's
Office
ICPMS Agilent 7900 G8403A JP14080164 See
KanbanFlo
w
Used ICPMS ICPMS 10 Supervisor's
Office
ICPMS Agilent 7900 G8403A JP17472096 See
KanbanFlo
w
Used ICPMS ICPMS 11 Supervisor's
Office
Refrigerator Maxx Cold MXM2-48RBHC 36031 Used TCLP P0136 On Line
TCLP Freezer Danby
Designer
DUFM043A1WDD 4315093419531 See
KanbanFlo
w
Used TCLP Missing Supervisor’s
Office
Stirrer/Hot Plate Thermo Cinarec+C301001311514
115
See
KanbanFlo
w
Used TCLP 1 Supervisor's
Office
Stirrer/Hot Plate IKA RT15 3.492224 See
KanbanFlo
w
Used TCLP 2 Supervisor's
Office
Stirrer/Hot Plate IKA RT15 3.503438 See
KanbanFlo
w
Used TCLP 3 Supervisor's
Office
Stirrer/Hot Plate IKA RT15 3.503438 See
KanbanFlo
w
Used TCLP 4 Supervisor's
Office
Stirrer/Hot Plate IKA RT15 3.527246 See
KanbanFlo
w
Used TCLP 5 Supervisor's
Office
Tumbler Environment
al Express
12 Position N/A See
KanbanFlo
w
Used TCLP A Supervisor's
Office
Tumbler Environment
al Express
12 Position N/A See
KanbanFlo
w
Used TCLP E Supervisor's
Office
Tumbler Environment
al Express
12 Position N/A See
KanbanFlo
w
Used TCLP I Supervisor's
Office
Tumbler Environment
al Express
12 Position N/A See
KanbanFlo
w
Used TCLP L Supervisor's
Office
Tumbler Environment
al Express
12 Position N/A See
KanbanFlo
w
Used TCLP O Supervisor's
Office
Draft
ENV-MAN-MTJL-0001 v03_Quality Manual
Effective Date: 8/15/2022 3:09:53 PM
COPYRIGHT © 2019-2022 Pace® Analytical Services, LLC.
Description Manufacturer Model Serial
Number
Service Date Condition Location Internal
ID
Manual
Location
Tumbler Environment
al Express
12 Position N/A See
KanbanFlo
w
Used TCLP S Supervisor's
Office
Tumbler Environment
al Express
12 Position N/A See
KanbanFlo
w
Used TCLP 1 Supervisor's
Office
Tumbler Environment
al Express
12 Position N/A See
KanbanFlo
w
Used TCLP 2 Supervisor's
Office
Tumbler Environment
al Express
12 Position N/A See
KanbanFlo
w
Used TCLP G Supervisor's
Office
Tumbler Environment
al Express
12 Position N/A See
KanbanFlo
w
Used TCLP H Supervisor's
Office
Tumbler Environment
al Express
12 Position N/A See
KanbanFlo
w
Used TCLP R Supervisor's
Office
Tumbler Environment
al Express
12 Position N/A See
KanbanFlo
w
Used TCLP B Supervisor's
Office
pH Meter Thermo OrionVerastar V04967 See
KanbanFlo
w
Used TCLP V04967 Supervisor's
Office
pH Meter Thermo OrionVerastarPro V11227 See
KanbanFlo
w
Used TCLP V11227 Supervisor's
Office
pH meter Thermo Orion VersastarPro V13429 See
KanbanFlo
w
Used TCLP V13429 Supervisor's
Office
Description Manufacturer Model Serial Number Service
Date
Condition Location Internal
ID
Manual
Location
Analytical
Balance
Mettler
Toledo
XSE1050DU B634906554 Annual New Microbiology
Lab
002929 Biomon
Class “I” weights (1 set)
Troemner
000565 Annual New Microbiology
Lab
N/A UKN
Autoclave Barstead Harvey 1277061222472 Annual New Microbiology
Lab
1708 Biomon
Water Bath Themo
Scientific
Precision CIR89 300380862 Annual Used Microbiology
Lab
UKN
Quantitray Sealer IDEXX 2X QTP13172302569 Monthly Used Microbiology
Lab
2803 Biomon
Incubator I10 Thermo
Scientific
Precision
PR505755L 300303584 Annual Used Microbiology
Lab
30T8 Biomon
Colony Counter Quebecor 3325 222649 N/A Microbiology
Lab
Stereoscope Olympus SZXZ-ILLD 9B48439 Annual Used Microbiology
Lab
P0125 Biomon
UV light; short
and long wave
Entela UVP-56 F122708 Quarterl
y
Used Microbiology
Lab
F122708 Biomon
Autoclave SterileMax Harvey 1277061222472 Annual Used Microbiology
Lab
1708 Biomon
pH meter/
Conductivity
meter/LDO
Thermo
Scientific
Orion
VStar pro V16919 Annual New Aquatic Tox
Lab
V16919 Biomon
Incubator I7-2 Thermo
Scintific
IGS100 42408345 Annual Used Aquatic Tox
Lab
P0141 Biomon
Incubator I7-1 Thermo
Scintific
IGS100 42408448 Annual New Aquatic Tox
Lab
P0132 Biomon
Draft
ENV-MAN-MTJL-0001 v03_Quality Manual
Effective Date: 8/15/2022 3:09:53 PM
COPYRIGHT © 2019-2022 Pace® Analytical Services, LLC.
Description Manufacturer Model Serial Number Service
Date
Condition Location Internal
ID
Manual
Location
Analytical
Balance
Mettler PL602-S 1125081657 Annual Unk Bacteriology
Lab
N/A Mold Lab
cabinet
Autoclave Tuttnauer 2540EK 2906170 Annual New Bacteriology
Lab
N/A Mold Lab
cabinet
Biolog
MicroStation
Biolog, Inc. Microlog 3 203222 Annual New Bacteriology
Lab
1676 Mold Lab
cabinet
BOD Skalar 2000 Skalar 2000 8123 Annual New BOD 1931 Mold Lab
cabinet
Class I BSC AirFiltronix AirFiltronix HS
4500
41031 Annual New Mold Lab 1505 Mold Lab
cabinet
Class II BSC Labconco Labconco 36209 30706555 Annual USed Bacteriology
Lab
1374 Mold Lab
cabinet
Class II BSC Labconco Labconco 36213 60554894 Annual USed Mold Lab N/A Mold Lab
cabinet
COD Reactor HACH 45600 900903221 N/A New BOD N/A Mold Lab
cabinet
YSI ProOBOD
LDS Probe
YSI 21C103980 N/A New BOD N/A Mold Lab
cabinet
YSI ProOBOD
LDS Probe
YSI 21C103978 N/A New BOD N/A Mold Lab
cabinet
YSI ProOBOD
LDS Probe
YSI 21G103335 N/A New BOD N/A Mold Lab
cabinet
Fisher Scientific
Vortex(q?)
Fisher
Scientific
80109016 N/A New Mold N/A No
Incubator Precision
Scientific
30M 309100 N/A New Bacteriology
Lab
1826 Mold lab
cabinet
Incubator Precision
Scientific
ER505755R 300245487 N/A New BOD P0127 Mold lab
cabinet
Incubator Thermo
Scientific
Precision
3721 233089-3323 N/A New BOD 2617 Mold Lab
cabinet
Incubator SHEL-LAB SR120P 09000719 N/A New BOD 3079 BOD lab
Incubator SHEL-LAB SR120P 09000819 N/A New BOD 3079 BOD Lab
Incubator SHEL-LAB SR120P 11003819 N/A New BOD N/A BOD Lab
Incubator VWR 2030 1000499 N/A New BOD 0902 Mold Lab
cabinet
Incubator Quincy Lab 10-100 I11-2454 N/A New Mold Lab N/A Mold lab
cabinet
Incubator Thermo
Precision
PR505755R 300207736 N/A New Mold Lab P0092 Mold lab
cabinet
Microscope NIKON LABOPHOT 230064 Annual Used Mold Lab N/A UKN
Microscope NIKON LABOPHOT 235267 Annual Used Mold Lab N/A UKN
Microscope Olympus CH2 9G0216 Annual Used Mold Lab N/a UKN
Microscope Olympus BH-2 200733 Annual Used Mold Lab 1597 UKN
Microscope Leitz Laborlux 512663 Annual Used Mold Lab N/A UKN
pH meter Thermo
Scientific
Orion Star A211 X59095 N/A New BOD N/A BOD lab
Refrigerator Frigidaire FRT17G4BW9 BA703033306 N/A NEW Mold Lab N/A UKN
Refrigerator Whirlpool EL88TRRWS03 442001106 N/A New Mold Lab N/A UKN
Refrigerator Whirlpool EL7ATRRMQ07 EWR4973976 N/A New Mold Lab N/A UKN
Refrigerator Whirlpool EL05PPXMQ EEP3524864 N/A NEW Bacteriology
Lab
N/A UKN
Spectrophotomet
er
Hach DR900 192180001065 N/A New BOD N/A BOD
Stereoscope VWR
Scientific
VWRS1 V168430 Annual Used Mold Lab N/A Mold lab
cabinet
Stir Plate VWR DYLA-DUAL 120202001 N/A New Bacteriology
Lab
N/A UKN
Stir Plate IKA Big Squid 102 N/A New Bacteriology
Lab
N/A UKN
Stir Plate VWR 7x7 AL4
HOT/STIR
180605003 N/A New BOD N/A UKN
Draft
ENV-MAN-MTJL-0001 v03_Quality Manual
Effective Date: 8/15/2022 3:09:53 PM
COPYRIGHT © 2019-2022 Pace® Analytical Services, LLC.
Description Manufacturer Model Serial Number Service
Date
Condition Location Internal
ID
Manual
Location
Stir Plate VWR 205 7852 N/A New BOD N/A UKN
Turbidimeter Biolog, Inc.21907 06093898 Annual New Bacteriology
Lab
N/A Mold lab
cabinet
Vortex Genie2
Mixer
VWR G-560 2-223236 N/A New Bacteriology
Lab
N/A UKN
Waterbath Fisher Sci FSGPD20 300302839 N/A New Bacteriology
Lab
N/A Mold lab
cabinet
Waterbath Precision Circulating 260 21-AJ11 N/A New BOD N/A Mold lab
cabinet
Description Manufacturer Model Serial Number Service
Date
Condition Location Internal
ID
Manual
Location
Flow control
valve
Plast-o-matic FC050B SA55CXFJN352 Semi-
annual
New Protozoan
Lab
N/A UKN
Centrifugal pump Jabsco 18610-0271 0562309-MA Semi-
annual
Unk Protozoan
Lab
N/A Crypto
Lab
Graduated
container
Nalgene 20 Liter Carboy N/A Semi-
annual
New Protozoan
Lab
N/A UKN
Laboratory
shaker
Lab-Line 3587-4 0105-2679 Annual New Protozoan
Lab
N/A Crypto
Lab
Laboratory
shaker side arms
Lab-Line 3589 0105-2679 Annual New Protozoan
Lab
N/A Crypto
Lab
1500 XG swinging
bucket centrifuge
Damon/IEC
Division
CRU-5000 23453388 Annual Unk Protozoan
Lab
1863 Crypto
Lab
1500 XG swinging
bucket centrifuge
Damon/IEC
Division
CRU-5000 23453744 Annual Unk Protozoan
Lab
1863 Crypto
Lab
1500 XG swinging
bucket centrifuge
Damon/IEC
Division
CRU-5000 2345497 annual unk Protozoan
Lab
1863 Crypto
Lab
Sample
mixer/rotator
DYNAL Car#: 947.01 1004-3765 Annual Unk Protozoan
Lab
RT1 UKN
Magnetic Particle
Concentrator
DYNAL MPC-1 N/A N/A Protozoan
Lab
N/A UKN
Magnetic Particle
Concentrator
DYNAL MPC-S N/A N/A Protozoan
Lab
N/A UKN
Magnetic Particle
Concentrator
DYNAL MPC-6 N/A N/A Protozoan
Lab
N/A UKN
Flat-sided sample
tubes
DYNAL Cat#: 740.03 74003 N/A New Protozoan
Lab
N/A UKN
Epifluorescence/
differential
interference
contract
microscope
Olympus BX-40 9E09944 Annual Protozoan
Lab
1554 Crypto
Lab
Excitation/ band
pass microscope
for fluorescein
isothiocyanate
(FTIC)
C-squared UN3100 023355 Annual Protozoan
Lab
1924 Crypto
Lab
Excitation/ band
pass filters for
4’6-diamidino-2-
phenylindole
(DAPI)
C-squared UN41001 8H2122 Annual Protozoan
Lab
N/A Crypto
Lab
Masterflex pump Cole Parmer 7553-50 Protozoan
Lab
Crypto
Lab
Balance Denver
Instrument
MXX-412 19053216 Annual Protozoan
Lab
Crypto
Lab
Biosafety Cabinet Labconco Cat#: 36208043726 050J372 Annual Protozoan
Lab
1557 Crypto
Lab
Draft
ENV-MAN-MTJL-0001 v03_Quality Manual
Effective Date: 8/15/2022 3:09:53 PM
COPYRIGHT © 2019-2022 Pace® Analytical Services, LLC.
Description Manufacturer Model Serial Number Service
Date
Condition Location Internal
ID
Manual
Location
Gas
Chromatograph 2
HP 6890 HP 6890 US00004397 As needed Used SVOC svcompa
Online
Gas
Chromatograph 3
Agilent 6890 Agilent 6890 US00002051 As needed Used SVOC svcompo
Online
Gas
Chromatograph 7
Agilent 6890 Agilent 6890 US10350064 As needed Used SVOC Svcompe
Online
Gas
Chromatograph 8
Agilent 6890 Agilent 6890 DE00022534 As needed Used SVOC svcompp Online
Gas
Chromatograph 9
HP 6890 HP 6890 US00029095 As needed Used SVOC Svcompj
Online
Gas
Chromatograph
10
Agilent 6890 Agilent 6890 US00039655 As needed Used SVOC Scvompk
Online
Gas
Chromatograph
11
Agilent 6890 Agilent 6890 US00040550 As needed Used SVOC Svcompn
Online
Gas
Chromatograph
12
Agilent 6890 Agilent 6890 US00034155 As needed Used SVOC Svcompaf
Online
Gas
Chromatograph
13
HP 6890 HP 6890 US00010364 As needed Used SVOC Svcomps
Online
Gas
Chromatograph
14
HP 6890 HP 6890 US00020581 As needed Used SVOC svcompt
Online
Gas
Chromatograph
16
Agilent 6890 Agilent 6890 US10212071 As needed Used SVOC Svcompv
Online
Gas
Chromatograph
17
Agilent 6890 Agilent 6890 US10344078 As needed Used SVOC Svcompw
Online
Gas
Chromatograph
18
Agilent 6890 Agilent 6890 US10351038 As needed Used SVOC Svcompd
Online
Gas
Chromatograph
19
Agilent 6890 Agilent 6890 CN10516070 As needed Used SVOC Svompaa
Online
Gas
Chromatograph
20
Agilent 6890 Agilent 6890 CN10543031 As needed Used SVOC Svcompa
b Online
Gas
Chromatograph
21
Agilent 7890 Agilent 7890 CN10730070 As needed Used SVOC Svcompa
e Online
Gas
Chromatograph
22
Agilent 7890 Agilent 7890 CN10730081 As needed Used SVOC svcompa
d Online
Gas
Chromatograph
23
Agilent 6890 Agilent 6890 CN92174366 As needed Used SVOC Svcompa
g Online
Gas
Chromatograph
24
Agilent 6890 Agilent 6890 CN92174369 As needed Used SVOC Svcompa
h Online
Gas
Chromatograph
25
Agilent 7890 Agilent 7890 CN10091009 As needed Used SVOC Svcompaj
Online
Gas
Chromatograph
26
Agilent 7890 Agilent 7890 CN11501138 As needed Used SVOC Svcompar
Online
Gas
Chromatograph
27
Agilent 7890 Agilent 7890 CN11501139 As needed Used SVOC Svcompas
Online
Gas
Chromatograph
28
Agilent 7890 Agilent 7890 US11521018 As needed Used SVOC Svcompat
Online
Draft
ENV-MAN-MTJL-0001 v03_Quality Manual
Effective Date: 8/15/2022 3:09:53 PM
COPYRIGHT © 2019-2022 Pace® Analytical Services, LLC.
Gas
Chromatograph
29
Agilent 7890 Agilent 7890 CN11521077 As needed Used SVOC Svcompa
u Online
Gas
Chromatograph
30
Agilent 7890 Agilent 7890 US11521020 As needed Used SVOC Svcompa
v Online
Gas
Chromatograph
31
Agilent 7890 Agilent 7890 CN13503096 As needed Used SVOC Svcompb
a Online
Gas
Chromatograph
32
Agilent 7890 Agilent 7890 CN14423060 As needed Used SVOC Svcompb
c Online
Gas
Chromatograph
33
Agilent 7890 Agilent 7890 CN15033026 As needed Used SVOC Svcompb
d Online
Gas
Chromatograph
34
Agilent 7890 Agilent 7890 CN15033027 As needed Used SVOC svcompb
e Online
Gas
Chromatograph
35
Agilent 7890 Agilent 7890 US10838014 As needed Used SVOC svcompb
h Online
Gas
Chromatograph
36
Agilent 7890 Agilent 7890 US10205134 As needed Used SVOC svcompbi
Online
Gas
Chromatograph
38
Agilent 7890 Agilent 7890 US10142052 As needed Used SVOC svcompb
k Online
Gas
Chromatograph
41
Agilent 7890 Agilent 7890 CN16123059 As needed Used SVOC svcompb
m Online
Gas
Chromatograph
42
Agilent 7890 Agilent 7890 US1952A007 As needed Used SVOC svcompb
p Online
Gas
Chromatograph
43
Agilent 7890 Agilent 7890 US1951A023 As needed Used SVOC svcompb
q Online
Gas
Chromatograph
45
Agilent 8890 Agilent 8890 US2016A022 As needed Used SVOC svcompb
x Online
Gas
Chromatograph
46
Agilent 7890 Agilent 7890 CN13443001 As needed Used SVOC svcompb
y Online
Gas
Chromatograph
47
Agilent 7890 Agilent 7890 CN10301152 As needed Used SVOC svcompb
z Online
Gas
Chromatograph
48
Agilent 6890 Agilent 6890 CN10344042 As needed Used SVOC svcompca
Online
Gas
Chromatograph
49
Agilent 7890 Agilent 7890 CN10814061 As needed Used SVOC svcompc
b Online
Gas
Chromatograph
50
Agilent 8890 Agilent 8890 US2119A057 As needed Used SVOC svcompcc
Online
Gas
Chromatograph
Detectors 2
FID Detector FID Detector N/A As needed Used SVOC scvompa
Online
Gas
Chromatograph
Detectors 3
NPD/NPD
Detectors
NPD/NPD
Detectors
N/A As needed Used SVOC Svcompo
Online
Gas
Chromatograph
Detectors 7
FID Detector FID Detector N/A As needed Used SVOC Svcompe
Online
Gas
Chromatograph
Detectors 8
FID Detector FID Detector N/A As needed Used SVOC Svcompp
Online
Draft
ENV-MAN-MTJL-0001 v03_Quality Manual
Effective Date: 8/15/2022 3:09:53 PM
COPYRIGHT © 2019-2022 Pace® Analytical Services, LLC.
Gas
Chromatograph
Detectors 9
FID Detector FID Detector N/A As needed Used SVOC Svcompj
Online
Gas
Chromatograph
Detectors 10
FID Detector FID Detector N/A As needed Used SVOC Svcompk
Online
Gas
Chromatograph
Detectors 11
ECD/ECD
Detectors
ECD/ECD
Detectors
F) U11750
B) U12481
As needed Used SVOC svcompn
Online
Gas
Chromatograph
Detectors 12
FPD/FPD
Detectors
FPD/FPD
Detectors
N/A As needed Used SVOC Svcompaf
Online
Gas
Chromatograph
Detectors 13
Detectors Detectors N/A As needed Used SVOC Svcomps
Online
Gas
Chromatograph
Detectors 14
ECD/ECD
Detectors
ECD/ECD
Detectors
F) U3113
B) U2620
As needed Used SVOC Svcompt
Online
Gas
Chromatograph
Detectors 16
FID Detector FID Detector N/A As needed Used SVOC Svcompv
Online
Gas
Chromatograph
Detectors 17
FID Detector FID Detector N/A As needed Used SVOC Svcompw
Online
Gas
Chromatograph
Detectors 18
ECD/ECD
Detectors
ECD/ECD
Detectors
F) U11613
B) U13988
As needed Used SVOC Svcompd
Online
Gas
Chromatograph
Detectors 19
ECD/ECD
Detectors
ECD/ECD
Detectors
F) U6632
B) U8422
As needed Used SVOC Svcompa
a Online
Gas
Chromatograph
Detectors 20
ECD/ECD
Detectors
ECD/ECD
Detectors
F) U13989
B) U0418
As needed Used SVOC Svcompa
b Online
Gas
Chromatograph
Detectors 21
FID Detector FID Detector N/A As needed Used SVOC Svcompa
e Online
Gas
Chromatograph
Detectors 22
ECD/ECD
Detectors
ECD/ECD
Detectors
F) U12039
B) 12038
As needed Used SVOC Svcompa
d Online
Gas
Chromatograph
Detectors 23
ECD/ECD
Detectors
ECD/ECD
Detectors
F) U2621
B) U8104
As needed Used SVOC Svcompa
g Online
Gas
Chromatograph
Detectors 24
ECD/ECD
Detectors
ECD/ECD
Detectors
F) U8423
B) U12482
As needed Used SVOC Svcompa
h Online
Gas
Chromatograph
Detectors 25
FID Detector FID Detector N/A As needed Used SVOC Svcompaj
Online
Gas
Chromatograph
Detectors 26
FID Detector FID Detector N/A As needed Used SVOC Svcompar
Online
Gas
Chromatograph
Detectors 27
FID Detector FID Detector N/A As needed Used SVOC Svcompas
Online
Gas
Chromatograph
Detectors 28
ECD/ECD
Detectors
ECD/ECD
Detectors
F) U26768
B) U26237
As needed Used SVOC Svcompat
Online
Gas
Chromatograph
Detectors 29au
ECD/ECD
Detectors
ECD/ECD
Detectors
F) U20277
B) U20299
As needed Used SVOC Svcompa
u Online
Gas
Chromatograph
Detectors 30
ECD/ECD
Detectors
ECD/ECD
Detectors
F) U20425
B) U20424
As needed Used SVOC Svcompa
v Online
Gas
Chromatograph
Detectors 31
FID Detector FID Detector N/A As needed Used SVOC Svcompb
a Online
Draft
ENV-MAN-MTJL-0001 v03_Quality Manual
Effective Date: 8/15/2022 3:09:53 PM
COPYRIGHT © 2019-2022 Pace® Analytical Services, LLC.
Gas
Chromatograph
Detectors 32
FID Detector FID Detector N/A As needed Used SVOC Svcompb
c Online
Gas
Chromatograph
Detectors 33
FID Detector FID Detector N/A As needed Used SVOC Svcompb
d Online
Gas
Chromatograph
Detectors 34
FID Detector FID Detector N/A As needed Used SVOC Svcompb
e Online
Gas
Chromatograph
Detectors 35
FID Detector FID Detector N/A As needed Used SVOC Svcompb
h Online
Gas
Chromatograph
Detectors 36
FID Detector FID Detector N/A As needed Used SVOC Svcompbi
Online
Gas
Chromatograph
Detectors 38
ECD/ECD
Detectors
ECD/ECD
Detectors
F) U14736
B) U16284
As needed Used SVOC Svcompb
k Online
Gas
Chromatograph
Detectors 41
NPD/NPD
Detectors
NPD/NPD
Detectors
N/A As needed Used SVOC Svcompb
p Online
Gas
Chromatograph
Detectors 42
ECD/ECD
Detectors
ECD/ECD
Detectors
F) U37659
B) U37661
As needed Used SVOC Svcompb
p Online
Gas
Chromatograph
Detectors 43
FID Detector FID Detector N/A As needed Used SVOC Svcompb
q Online
Gas
Chromatograph
Detectors 45
FID Detector FID Detector N/A As needed Used SVOC Svcompb
x Online
Gas
Chromatograph
Detectors 46
ECD/ECD
Detectors
ECD/ECD
Detectors
F) U39219
B) U39356
As needed Used SVOC Svcompb
y Online
Gas
Chromatograph
Detectors 47
FID Detector FID Detector N/A As needed Used SVOC Svcompb
z Online
Gas
Chromatograph
Detectors 48
FID Detector FID Detector N/A As needed Used SVOC Svcompc
a Online
Gas
Chromatograph
Detectors 49
FPD/FPD
Detectors
FPD/FPD
Detectors
N/A As needed Used SVOC Svcompc
b Online
Gas
Chromatograph
Detectors 50
FID Detector FID Detector N/A As needed Used SVOC Svcompc
c Online
Gas
Chromatograph/
Mass
Spectrometer 1
Agilent
6890GC
5973 MSD
Agilent 6890GC
5973 MSD
GC CN10335001
MS US33220022
As needed Used SVOC Svcompf
Online
Gas
Chromatograph/
Mass
Spectrometer 2
Agilent
6890GC
5973 MSD
Agilent 6890GC
5973 MSD
GC US10409048
MS US35120400
As needed Used SVOC Svcompc
Online
Gas
Chromatograph/
Mass
Spectrometer 4
Agilent
6890GC
5973 MSD
Agilent 6890GC
5973 MSD
GC CN10403067
MS US35120308
As needed Used SVOC Svcomph
Online
Gas
Chromatograph/
Mass
Spectrometer 7
Agilent
6890GC
5973 MSD
Agilent 6890GC
5973 MSD
GC US00023180
MS US03940745
As needed Used SVOC svcompm
Online
Gas
Chromatograph/
Mass
Spectrometer 9
Agilent
6890GC
5973 MSD
Agilent 6890GC
5973 MSD
GC CN10344042
MS US33220158
As needed Used SVOC Svcompx Decomm
issioned
and
repurpos
ed as
SVGC48
Draft
ENV-MAN-MTJL-0001 v03_Quality Manual
Effective Date: 8/15/2022 3:09:53 PM
COPYRIGHT © 2019-2022 Pace® Analytical Services, LLC.
Gas
Chromatograph/
Mass
Spectrometer 10
Agilent
6890GC
5973 MSD
Agilent 6890GC
5973 MSD
GC CN10340045
MS US33220183
As needed Used SVOC Svcompy
Online
Gas
Chromatograph/
Mass
Spectrometer 11
Agilent
6890GC
5975 MSD
Agilent 6890GC
5975 MSD
GC CN10509031
MS US60532657
As needed Used SVOC Svcompa
c Online
Gas
Chromatograph/
Mass
Spectrometer 12
Agilent
7890GC
5975 MSD
Agilent 7890GC
5975 MSD
GC CN10728074
MS 12-0706-1325
As needed Used SVOC Svcompai
Online
Gas
Chromatograph/
Mass
Spectrometer 13
Agilent
7890GC
5975 MSD
Agilent 7890GC
5975 MSD
GC CN10301081
MS US10313621
As needed Used SVOC Svcompa
k Online
Gas
Chromatograph/
Mass
Spectrometer 14
Agilent
7890GC
5975 MSD
Agilent 7890GC
5975 MSD
GC CN11031022
MS US11093726
As needed Used SVOC Svcompal
Online
Gas
Chromatograph/
Mass
Spectrometer 15
Agilent
7890GC
5975 MSD
Agilent 7890GC
5975 MSD
GC CN10301081
MS US10313621
As needed Used SVOC Svcompa
m Online
Gas
Chromatograph/
Mass
Spectrometer 16
Agilent
7890GC
5975 MSD
Agilent 7890GC
5975 MSD
GC CN10301152
MS US10313616
As needed Used SVOC Svcompa
n
Decomm
issioned
and
repurpos
ed as
SVGC47
Gas
Chromatograph/
Mass
Spectrometer 17
Agilent
7890GC
5975 MSD
Agilent 7890GC
5975 MSD
GC CN11191064
MS US11363807
As needed Used SVOC Svcompa
o Online
Gas
Chromatograph/
Mass
Spectrometer 18
Agilent
7890GC
5975 MSD
Agilent 7890GC
5975 MSD
GC CN11401093
MS US11403903
As needed Used SVOC Svcompa
p Online
Gas
Chromatograph/
Mass
Spectrometer 19
Agilent
7890GC
5975 MSD
Agilent 7890GC
5975 MSD
GC CN 11391051
MS US11383838
As needed Used SVOC Svcompa
q Online
Gas
Chromatograph/
Mass
Spectrometer 20
Agilent
7890GC
5975 MSD
Agilent 7890GC
5975 MSD
GC CN12031161
MS US11503941
As needed Used SVOC Svcompa
w Online
Gas
Chromatograph/
Mass
Spectrometer 21
Agilent
7890GC
5975 MSD
Agilent 7890GC
5975 MSD
GC CN12031160
MS US11513903
As needed Used SVOC Svcompa
x Online
Gas
Chromatograph/
Mass
Spectrometer 22
Agilent
7890GC
5975 MSD
Agilent 7890GC
5975 MSD
GC CN11521157
MS US12023909
As needed Used SVOC Svcompa
y Online
Gas
Chromatograph/
Mass
Spectrometer 23
Agilent
7890GC
5975 MSD
Agilent 7890GC
5975 MSD
GC CN12031114
MS US11433926
As needed Used SVOC Svcompa
z Online
Gas
Chromatograph/
Mass
Spectrometer 24
Agilent
7890GC
5977 MSD
Agilent 7890GC
5977 MSD
GC CN14163165
MS US92043581
As needed Used SVOC Svcompb
b Online
Gas
Chromatograph/
Mass
Spectrometer 25
Agilent
7890GC
5975 MSD
Agilent 7890GC
5975 MSD
GC CN10906031
MS US11343905
As needed Used SVOC Svcompbf
Online
Draft
ENV-MAN-MTJL-0001 v03_Quality Manual
Effective Date: 8/15/2022 3:09:53 PM
COPYRIGHT © 2019-2022 Pace® Analytical Services, LLC.
Gas
Chromatograph/
Mass
Spectrometer 26
Agilent
7890GC
5975 MSD
Agilent 7890GC
5975 MSD
GC CN10021075
MS US10143111
As needed Used SVOC Svcompbl Online
Gas
Chromatograph/
Mass
Spectrometer
(QQQ) 27
Agilent
7890GC
7010 MSD
(QQQ)
Agilent 7890GC
7010 MSD (QQQ)
GC US18373018
MS US1730V003
As needed Used SVOC Svcompb
n
Transferr
ed to
IDEA
Lab.
Gas
Chromatograph/
Mass
Spectrometer 28
Agilent
7890GC
5977 MSD
Agilent 7890GC
5977 MSD
GC CN13483185
MS US1349M227
As needed Used SVOC Svcompb
o
Online
Gas
Chromatograph/
Mass
Spectrometer 29
Agilent
8890GC
5977 MSD
Agilent 8890GC
5977 MSD
GC US1951A019
MS US1952M030
As needed Used SVOC Svcompbr Online
Gas
Chromatograph/
Mass
Spectrometer 30
Agilent
8890GC
5977 MSD
Agilent 8890GC
5977 MSD
GC US1947A006
MS US2040M022
As needed Used SVOC Svcompb
s
Online
Gas
Chromatograph/
Mass
Spectrometer 31
Agilent
8890GC
5977 MSD
Agilent 8890GC
5977 MSD
GC US2014A033
MS US2041M031
As needed Used SVOC Svcompb
u
Online
Gas
Chromatograph/
Mass
Spectrometer 32
Agilent
8890GC
5977 MSD
Agilent 8890GC
5977 MSD
GC US2016A007
MS US2041M015
As needed Used SVOC Svcompb
v
Online
Gas
Chromatograph/
Mass
Spectrometer 33
Agilent
8890GC
5977 MSD
Agilent 8890GC
5977 MSD
GC US2014A035
MS US2040M015
As needed Used SVOC Svcompb
w
Online
Liquid
Chromatograph/
Mass
Spectrometer
(QQQ)
LCMSMS1
Agilent
1290/1290/
1290LC
6470 MSD
(QQQ)
Agilent 1290LC
6470 MSD (QQQ)
Multisampler
DEBAS01954
MS/MS
SG1846G104
Pump
DEBA202992
MCT
DEBA404366
As needed Used SVOC LCMSMS
1
Online
Liquid
Chromatograph/
Mass
Spectrometer
(QQQ)
LCMSMS2
Agilent
1260/1200/
1200LC
6460 MSD
(QQQ)
Agilent 1260/1200/
1200LC
6460 MSD (QQQ)
Multisampler
DEAAC40230
MS/MS
SG11477210
Pump
DEAB715448
TCC
DEACN42876
As needed Used SVOC LCMSMS
2
In
develop
ment
High
Performance
Liquid
Chromatography
(HPLC1)
Agilent 1100
Series
DAD/FLD
Agilent 1100 Series
DAD/FLD
DAD de01608402
FLD de23904489
As needed Used SVOC Hplc1
Online
High
Performance
Liquid
Chromatography
(HPLC2)
Agilent 1100
Series
DAD/FLD
Agilent 1100 Series
DAD/FLD
DAD de30518420
FLD de92001880
As needed Used SVOC Hplc2
Online
High
Performance
Liquid
Chromatography
Agilent 1100
Series
DAD
Agilent 1100 Series
DAD
DAD us64400711 As needed Used SVOC Hplc3
Online
High
Performance
Liquid
Chromatography
Agilent 1100
Series
DAD
Agilent 1100 Series
DAD
DAD de43623013 As needed Used SVOC Hplc4 Online
Draft
ENV-MAN-MTJL-0001 v03_Quality Manual
Effective Date: 8/15/2022 3:09:53 PM
COPYRIGHT © 2019-2022 Pace® Analytical Services, LLC.
Analytical
Balance
Mettler-
Toledo XS204
1122411619 As needed Used Ext. Lab Book
shelf
Automated
Soxhlet
Gerhardt
Soxtherm
2951 As needed Used Ext. Lab #1 In lab on
shelf next
to
instrume
nt
Automated
Soxhlet
Gerhardt
Soxtherm
2952 As needed Used Ext. Lab #2 In lab on
shelf next
to
instrume
nt
Automated
Soxhlet
Gerhardt
Soxtherm
2953 As needed Used Ext. Lab #3 In lab on
shelf next
to
instrume
nt
Automated
Soxhlet
Gerhardt
Soxtherm
2954 As needed Used Ext. Lab #4 In lab on
shelf next
to
instrume
nt
Centrifuge Sorvall ST-41 2225 As needed Used Ext. Lab Book
shelf in
lab
Centrifuge Sorvall ST-41 2227 As needed Used Ext. Lab Book
shelf in
lab
Microwave CEM MARS
6
MJ2518 As needed Used Ext. Lab #3 Book
shelf in
lab
Microwave CEM MARS
6
MJ6367 As needed Used Ext. Lab #4 Book
shelf in
lab
Microwave CEM MARS
6
MJZ868 As needed Used Ext. Lab #2 Book
shelf in
lab
Microwave CEM MARS
6
MARS 6 MY2163 As needed New Ext. Lab #5 Book
shelf in
lab
Microwave CEM MARS
6
MARS 6 MY2132 As needed New Ext. Lab #6 Book
shelf in
lab
O&G Solvent
Evaporator
Horizon
Speed-Vap
III
04-2020 As needed Used Ext. Lab #1 Book
shelf in
lab
O&G Solvent
Evaporator
Horizon
Speed-Vap
III
03-1001 As needed Used Ext. Lab #3 Book
shelf in
lab
O&G Solvent
Evaporator
Horizon
Speed-Vap IV
15-0055 As needed Used Ext. Lab #4 Book
shelf in
lab
O&G Solvent
Evaporator
Horizon
Speed-Vap IV
15-0056 As needed Used Ext. Lab #2 Book
shelf in
lab
O&G SPE
Extractor
Horizon
SPE-DEX
3100
15-0113 As needed Used Ext. Lab Disk in
lab
O&G SPE
Extractor
Horizon
SPE-DEX
3100
15-0116 As needed Used Ext. Lab Disk in
lab
O&G SPE
Extractor
Horizon
SPE-DEX
3100
15-0117 As needed Used Ext. Lab Disk in
lab
O&G SPE
Extractor
Horizon
SPE-DEX
3100
15-0118 As needed Used Ext. Lab Disk in
lab
Draft
ENV-MAN-MTJL-0001 v03_Quality Manual
Effective Date: 8/15/2022 3:09:53 PM
COPYRIGHT © 2019-2022 Pace® Analytical Services, LLC.
Oven Fisher 00700127 As needed Used Ext. Lab Bookshel
f in lab
Oven Fisher 1000594
F210266022FD
As needed Used Ext. Lab Bookshel
f in lab
Ring & Puck Mill SPEX
ShatterBOX
8530
10191 As needed Used Ext. Lab Bookshel
f in lab
Sonicator Qsonica Q700 92183M-16-16 As needed Used Ext. Lab Bookshel
f in lab
Sonicator Qsonica Q700 92186M-10-16 As needed Used Ext. Lab Bookshelf
in lab
Sonicator Qsonica Q700 92189M-10-16 As needed Used Ext. Lab Bookshelf
in lab
Sonicator Qsonica Q700 9219M-10-16 As needed Used Ext. Lab Bookshelf
in lab
Sonicator Qsonica Q700 Q700 120131U-05-21 As needed New Ext. Lab #5 Bookshelf
in lab
Sonicator Qsonica Q700 Q700 120137U-05-21 As needed New Ext. Lab #6 Bookshelf
in lab
Water Bath ThermoScien
tific
2033602-102 As needed Used Ext. Lab Bookshelf
in lab
Water Bath Gant VH1535002 As needed Used EXT. Lab Bookshelf
Microwave CEM MARS
Xpress
MD2861 As needed New EXT. Lab #1 Decommi
ssioned
Centrifuge Sorvall ST-41 42498357 As needed Used EXT. Lab Bookshelf
Concentrator Buchi Buchi Syncore
Plus
1100082324 As needed New EXT. Lab #1 Bookshelf
Concentrator Buchi Buchi Syncore
Plus
1100082473 As needed New EXT. Lab #2 Bookshelf
Concentrator Buchi Buchi Syncore
Plus
1100084062 As needed New EXT. Lab #3 Bookshelf
Concentrator Buchi Buchi Syncore
Plus
1100084063 As needed New EXT. Lab #4 Bookshelf
Concentrator XcelVap Horizon
Technologies
17-5548 As needed Used EXT. Lab On Disc
in Lab
Concentrator XcelVap Horizon
Technologies
19-5688 As needed Used EXT. Lab On Disc
in Lab
Concentrator XcelVap Horizon
Technologies
17-5564 As needed Used EXT. Lab On Disc
in Lab
Concentrator XcelVap Horizon
Technologies
17-5686 As needed Used EXT. Lab On Disc
in Lab
Concentrator XcelVap Horizon
Technologies
19-5687 As needed Used EXT. Lab On Disc
in Lab
Concentrator XcelVap Horizon
Technologies
17-5549 As needed Used EXT. Lab On Disc
in Lab
Concentrator XcelVap Horizon
Technologies
17-5541 As needed Used EXT. Lab On Disc
in Lab
Concentrator XcelVap Horizon
Technologies
17-5545 As needed Used EXT. Lab On Disc
in Lab
Concentrator XcelVap Horizon
Technologies
17-5547 As needed Used EXT. Lab On Disc
in Lab
Concentrator XcelVap Horizon
Technologies
18-5619 As needed Used EXT. Lab On Disc
in Lab
O/G SPE
Extractor
Horizon
Technologies
15-0104 As needed Used EXT. Lab On Disc
in Lab
O/G SPE
Extractor
Horizon
Technologies
16-0169 As needed Used EXT. Lab On Disc
in Lab
O&G Solvent
Evaporator
Horizon
Speed-Vap IV
Horizon Speed-
Vap IV
10-0778 As needed Used EXT. Lab Bookshelf
in Lab
O&G Solvent
Evaporator
Horizon
Speed-Vap IV
Horizon Speed-
Vap IV
04-2020 As needed Used EXT. Lab Bookshelf
in Lab
Analytical
Balance
Rad Wag 552935 As needed Used EXT. Lab EXTBAL
#4
Bookshelf
in Lab
Analytical
Balance
Rad Wag 537906 As needed Used EXT. Lab EXTBAL
#3
Bookshelf
in Lab
Draft
ENV-MAN-MTJL-0001 v03_Quality Manual
Effective Date: 8/15/2022 3:09:53 PM
COPYRIGHT © 2019-2022 Pace® Analytical Services, LLC.
Analytical
Balance
Rad Wag 552941 As needed Used EXT. Lab EXTBAL
#5
Bookshelf
in Lab
Analytical
Balance
Rad Wag 545380 As needed Used EXT. Lab EXTBAL
#7
Bookshelf
in Lab
Analytical
Balance
Rad Wag 537906 As needed Used EXT. Lab EXTBAL
#9
Bookshelf
in Lab
Description Manufacturer Model Serial Number Service
Date
Condit
ion
Location Internal
ID
Manual
Location
Gas
Chromatograph
Hewlett
Packard
5890 Series II 3336A60095 As Needed Used Volatiles VOCGC1
FID1A= FID
FID2B= PID
Online
Gas
Chromatograph
Agilent 6890 CN10609095 As Needed Used Volatiles VOCGC2
FID1A= FID
ELC2B= PID
Online
Gas
Chromatograph
Hewlett
Packard
5890 Series II 3336A50614 As Needed Used Volatiles VOCGC4
FID1A= FID
FID2B= PID
Online
Gas
Chromatograph
Hewlett
Packard
5890 Series II 3027A29678 As Needed Used Volatiles VOCGC5
FID1A= FID
FID2B= PID
Online
Gas
Chromatograph
Hewlett
Packard
5890 Series II 2950A27895 As Needed Used Volatiles VOCGC6
FID1A= FID
FID2B= PID
Online
Gas
Chromatograph
Hewlett
Packard
5890 Series II 3336A55283 As Needed Used Volatiles VOCGC7
FID1A= FID
FID2B= PID
Online
Gas
Chromatograph
Agilent 6890 US00022519 As Needed Used Volatiles VOCGC10
FID1A= FID
FID2B= PID
Online
Gas
Chromatograph
Agilent 6890 US00040221 As Needed Used Volatiles VOCGC12
FID1A= FID
FID2B= PID
Online
Gas
Chromatograph
Hewlett
Packard
5890 Series II 2921A23548 As Needed Used Volatiles VOCGC13
FID1A= FID
FID2B= PID
Online
Gas
Chromatograph
Agilent 6890 CN10406054 As Needed Used Volatiles VOCGC14
FID1A= FID
ELC2B= PID
Online
Gas
Chromatograph
Agilent 6890 US10232130 As Needed Used Volatiles VOCGC15
ELC1A= FID
ELC2B= PID
Online
Gas
Chromatograph
Agilent 8890 GC GC US2120A021 As Needed Used Volatiles VOCGC16
FID1A=FID
FID2B=PID
Online
Gas
Chromatograph/
Mass
Spectrometer
Agilent 6890 GC
5975 MSD
GC CN10517046
MS US63234371
As Needed Used Volatiles VOCMS2 Online
Gas
Chromatograph/
Mass
Spectrometer
Agilent 6890 GC
5973 MSD
GC US00023465
MS US82311257
As Needed Used Volatiles VOCMS4 Online
Gas
Chromatograph/
Mass
Spectrometer
Agilent 6890 GC
5973 MSD
GC CN10343037
MS US44647141
As Needed Used Volatiles VOCMS6 Online
Gas
Chromatograph/
Mass
Spectrometer
Agilent 6890 GC
5973 MSD
GC CN10339006
MS US33220045
As Needed Used Volatiles VOCMS13 Online
Gas
Chromatograph/
Mass
Spectrometer
Agilent 6890 GC
5973 MSD
GC US00006479
MS US82321899
As Needed Used Volatiles VOCMS16 Online
Draft
ENV-MAN-MTJL-0001 v03_Quality Manual
Effective Date: 8/15/2022 3:09:53 PM
COPYRIGHT © 2019-2022 Pace® Analytical Services, LLC.
Description Manufacturer Model Serial Number Service
Date
Condit
ion
Location Internal
ID
Manual
Location
Gas
Chromatograph/
Mass
Spectrometer
Agilent 6890 GC
5975 MSD
GC CN621A4367
MS US469A4832
As Needed Used Volatiles VOCMS20 Online
Gas
Chromatograph/
Mass
Spectrometer
Agilent 6890 GC
5975 MSD
GC CN621A4368
MS US469A4833
As Needed Used Volatiles VOCMS21 Online
Gas
Chromatograph/
Mass
Spectrometer
Agilent 7890 GC
5975 MSD
GC CN99205324
MS US54441572
As Needed Used Volatiles VOCMS22 Online
Gas
Chromatograph/
Mass
Spectrometer
Agilent 7890 GC
5975 MSD
GC CN10728068
MS US71236616
As Needed Used Volatiles VOCMS23 Online
Gas
Chromatograph/
Mass
Spectrometer
Agilent 6890 GC
5975 MSD
GC CN10728074
MS US98003634
As Needed Used Volatiles VOCMS25 Online
Gas
Chromatograph/
Mass
Spectrometer
Agilent 6890 GC
5975 MSD
GC CN11381060
MS US11383834
As Needed Used Volatiles VOCMS26 Online
Gas
Chromatograph/
Mass
Spectrometer
Agilent 7890 GC
5975 MSD
GC CN10301155
MS US10313619
As Needed Used Volatiles VOCMS27 Online
Gas
Chromatograph/
Mass
Spectrometer
Agilent 6890 GC
5973 MSD
GC US10208101
MS US10442380
As Needed Used Volatiles VOCMS28 Online
Gas
Chromatograph/
Mass
Spectrometer
Agilent 6890 GC
5973 MSD
GC US000034135
MS US94240103
As Needed Used Volatiles VOCMS30 Online
Gas
Chromatograph/
Mass
Spectrometer
Agilent 7890 GC
5975 MSD
GC CN13113015
MS US92013978
As Needed Used Volatiles VOCMS32 Online
Gas
Chromatograph/
Mass
Spectrometer
Agilent 7890 GC
5975 MSD
GC CN11351165
MS US63810153
As Needed Used Volatiles VOCMS33 Online
Gas
Chromatograph/
Mass
Spectrometer
Agilent 7890 GC
5975 MSD
GC CN10849077
MS US83131017
As Needed Used Volatiles VOCMS35 Online
Gas
Chromatograph/
Mass
Spectrometer
Agilent 7890 GC
5975 MSD
GC CN13153007
MS US83141150
As Needed Used Volatiles VOCMS36 Online
Gas
Chromatograph/
Mass
Spectrometer
Agilent 7890 GC
5977 MSD
GC CN15333012
MS US1534M407
As Needed Used Volatiles VOCMS37 Online
Gas
Chromatograph/
Mass
Spectrometer
Agilent 7890 GC
5975 MSD
GC CN11281031
MS US1713D003
As Needed Used Volatiles VOCMS38 Online
Gas
Chromatograph/
Mass
Spectrometer
Agilent 7890A GC
5977A MS
GC CN10151020
MS US1417L240
As Needed Used Volatiles VOCMS39 Online
Draft
ENV-MAN-MTJL-0001 v03_Quality Manual
Effective Date: 8/15/2022 3:09:53 PM
COPYRIGHT © 2019-2022 Pace® Analytical Services, LLC.
Description Manufacturer Model Serial Number Service
Date
Condit
ion
Location Internal
ID
Manual
Location
Gas
Chromatograph/
Mass
Spectrometer
Agilent 7890B GC
5977A MSD
GC CN15133171
MS US1542L427
As Needed Used Volatiles VOCMS40 Online
Gas
Chromatograph/
Mass
Spectrometer
Agilent 7890B GC
5977B MS
GC CN10940090
MS US1705M027
As Needed Used Volatiles VOCMS41 Online
Gas
Chromatograph/
Mass
Spectrometer
Agilent 7890B GC
5977B MS
GC CN17010001
MS US1706M049
As Needed Used Volatiles VOCMS42 Online
Gas
Chromatograph/
Mass
Spectrometer
Agilent Intuvo 9000 GC
5977HES MS
GC CN17040005
MS US1714D003
As Needed Used Volatiles VOCMS44 Online
Gas
Chromatograph/
Mass
Spectrometer
Agilent 7890B GC
5973 MSD
GC US14453011
MS US1451L418
As Needed Used Volatiles VOCMS52 Online
Gas
Chromatograph/
Mass
Spectrometer
Agilent 8890B GC
5977B MS
GC US1946A049
MS US1945M023
As Needed New Volatiles VOCMS53 Online
Gas
Chromatograph/
Mass
Spectrometer
Agilent 8890B GC
5977B MS
GC US1946A050
MS US1946M007
As Needed New Volatiles VOCMS54 Online
Gas
Chromatograph/
Mass
Spectrometer
Agilent 8890B GC
5977B MS
GC US1946A054
MS US1946M008
As Needed New Volatiles VOCMS55 Online
Gas
Chromatograph/
Mass
Spectrometer
Agilent 8890B GC
5977B MS
GC US1946A056
MS US1945M026
As Needed New Volatiles VOCMS56 Online
as
Chromatograph/
Mass
Spectrometer
Agilent 8890 GC
5977B MS
GC US1947A068
MS US2040M031
As Needed New Volatiles VOCMS57 Online
as
Chromatograph/
Mass
Spectrometer
Agilent 8890 GC
5977B MS
GC US2014A037
MS US2041M011
As Needed New Volatiles VOCMS58 Online
as
Chromatograph/
Mass
Spectrometer
Agilent 8890 GC
5977B MS
GC US2014A036
MS US2040M033
As Needed New Volatiles VOCMS59 Online
Centurion
Autosampler
PTS/EST Centurion CENTS385091214 As Needed Used Volatiles VOCGC2 Online
Centurion
Autosampler
PTS/EST Centurion CENTS368051214 As Needed Used Volatiles VOCMS6 Online
Centurion
Autosampler
PTS/EST Centurion CENTS500041117 As Needed Used Volatiles VOCMS13 Online
Centurion
Autosampler
PTS/EST Centurion CENTW80106212
1
As Needed Used Volatiles VOCMS16 Online
Centurion
Autosampler
PTS/EST Centurion CENTS396112014 As Needed Used Volatiles VOCMS21 Online
Centurion
Autosampler
PTS/EST Centurion CENTW80306212
1
As Needed Used Volatiles VOCMS22 Online
Centurion
Autosampler
PTS/EST Centurion CENTS386091214 As Needed Used Volatiles VOCMS23 Online
Centurion
Autosampler
PTS/EST Centurion CENTS754102820 As Needed Used Volatiles VOCMS25 Online
Draft
ENV-MAN-MTJL-0001 v03_Quality Manual
Effective Date: 8/15/2022 3:09:53 PM
COPYRIGHT © 2019-2022 Pace® Analytical Services, LLC.
Description Manufacturer Model Serial Number Service
Date
Condit
ion
Location Internal
ID
Manual
Location
Centurion
Autosampler
PTS/EST Centurion CENTS170072010 As Needed Used Volatiles VOCMS26 Online
Centurion
Autosampler
PTS/EST Centurion CENTS375071714 As Needed Used Volatiles VOCMS30 Online
Centurion
Autosampler
PTS/EST Centurion CENTS163052610 As Needed Used Volatiles VOCMS33 Online
Centurion
Autosampler
PTS/EST Centurion CENTW80206212
1
As Needed Used Volatiles VOCMS36 Online
Centurion
Autosampler
PTS/EST Centurion CENTW80406212
1
As Needed Used Volatiles VOCMS37 Online
Centurion
Autosampler
PTS/EST Centurion CENTS171072010 As Needed Used Volatiles VOCMS39 Online
Centurion
Autosampler
PTS/EST Centurion CENTS338112213 As Needed Used Volatiles VOCMS40 Online
Centurion
Autosampler
PTS/EST Centurion CENTS395112014 As Needed Used Volatiles VOCMS42 Online
Centurion
Autosampler
PTS/EST Centurion CENTS499041117 As Needed Used Volatiles VOCMS44 Online
Centurion
Autosampler
PTS/EST Centurion CENTS667111119 As Needed Used Volatiles VOCMS53 Online
Centurion
Autosampler
PTS/EST Centurion CENTS664110519 As Needed Used Volatiles VOCMS54 Online
Centurion
Autosampler
PTS/EST Centurion CENTS673120319 As Needed Used Volatiles VOCMS55 Online
Centurion
Autosampler
PTS/EST Centurion CENTS674120319 As Needed Used Volatiles VOCMS56 Online
Centurion
Autosampler
PTS/EST Centurion CENTS756102820 As Needed Used Volatiles VOCMS57 Online
Centurion
Autosampler
PTS/EST Centurion CENTS755102820 As Needed Used Volatiles VOCMS58 Online
Centurion
Autosampler
PTS/EST Centurion CENTW80006212
1
As Needed Used Volatiles VOCMS59 Online
Autosampler Varian Archon 13809 As Needed Used Volatiles VOCGC1 Online
Autosampler Varian Archon 13999 As Needed Used Volatiles VOCGC4 Online
Autosampler Varian Archon 13454 As Needed Used Volatiles VOCGC5 Online
Autosampler Varian Archon 14157 As Needed Used Volatiles VOCGC6 Online
Autosampler Varian Archon 14599 As Needed Used Volatiles VOCGC7 Online
Autosampler Varian Archon 13391 As Needed Used Volatiles VOCGC10 Online
Autosampler Varian Archon VOLARCHON1 As Needed Used Volatiles VOCGC12 Online
Autosampler Varian Archon 13827 As Needed Used Volatiles VOCGC14 Online
Autosampler Varian Archon 13810 As Needed Used Volatiles VOCGC15 Online
Autosampler Varian Archon 15261 As Needed Used Volatiles VOCGC16 Online
Autosampler Varian Archon 14143 As Needed Used Volatiles VOCMS2 Online
Autosampler Varian Archon 14605 As Needed Used Volatiles VOCMS27 Online
Autosampler Varian Archon 14233 As Needed Used Volatiles VOCMS28 Online
Autosampler Teledyne Centurion CENTS317080513 As Needed Used Volatiles VOCMS4 Online
Autosampler Teledyne Atomx US14330003 As Needed Used Volatiles VOCMS52 Online
Autosampler OI Analytical 4100 D645410849 As Needed Used Volatiles VOCMS20 Online
Autosampler OI Analytical 4100 D627410770 As Needed Used Volatiles VOCMS32 Online
Autosampler OI Analytical 4100 D649410582 As Needed Used Volatiles VOCMS35 Online
Autosampler OI Analytical 4100 D619410106 As Needed Used Volatiles VOCMS38 Online
Autosampler OI Analytical 4100 D705410973 As Needed Used Volatiles VOCMS41 Online
Purge and Trap OI Analytical Eclipse 4660 D833466009P As Needed Used Volatiles VOCGC6 Online
Purge and Trap OI Analytical Eclipse 4660 F023466618P As Needed Used Volatiles VOCGC16 Online
Purge and Trap OI Analytical Eclipse 4660 D726466961P As Needed Used Volatiles VOCMS2 Online
Purge and Trap OI Analytical Eclipse 4660 D742466578P As Needed Used Volatiles VOCMS16 Online
Purge and Trap OI Analytical Eclipse 4660 F026466142P As Needed Used Volatiles VOCMS26 Online
Purge and Trap OI Analytical Eclipse 4660 F024466460P As Needed Used Volatiles VOCMS27 Online
Purge and Trap OI Analytical Eclipse 4660 F026466139P As Needed Used Volatiles VOCMS28 Online
Purge and Trap OI Analytical Eclipse 4760 21J102730 As Needed Used Volatiles VOCMS32 Online
Purge and Trap OI Analytical Eclipse 4660 D736466413P As Needed Used Volatiles VOCMS33 Online
Purge and Trap OI Analytical Eclipse 4660 D713466087P As Needed Used Volatiles VOCMS35 Online
Purge and Trap OI Analytical Eclipse 4660 E851466095P As Needed Used Volatiles VOCMS39 Online
Draft
ENV-MAN-MTJL-0001 v03_Quality Manual
Effective Date: 8/15/2022 3:09:53 PM
COPYRIGHT © 2019-2022 Pace® Analytical Services, LLC.
Description Manufacturer Model Serial Number Service
Date
Condit
ion
Location Internal
ID
Manual
Location
Purge and Trap OI Analytical Eclipse 4760 21J102729 As Needed Used Volatiles VOCMS20 Online
Purge and Trap OI Analytical Eclipse 4760 21J102727 As Needed Used Volatiles VOCMS25 Online
Purge and Trap OI Analytical Eclipse 4760 A627447776 As Needed Used Volatiles VOCMS37 Online
Purge and Trap OI Analytical Eclipse 4760 21J102728 As Needed Used Volatiles VOCMS38 Online
Purge and Trap OI Analytical Eclipse 4760 A620447864 As Needed Used Volatiles VOCMS40 Online
Purge and Trap OI Analytical Eclipse 4760 A703447399 As Needed Used Volatiles VOCMS41 Online
Purge and Trap OI Analytical Eclipse 4760 A707447491 As Needed Used Volatiles VOCMS42 Online
Purge and Trap OI Analytical Eclipse 4760 A942447703 As Needed Used Volatiles VOCMS53 Online
Purge and Trap OI Analytical Eclipse 4760 A031447210 As Needed Used Volatiles VOCMS54 Online
Purge and Trap OI Analytical Eclipse 4760 A946447334 As Needed Used Volatiles VOCMS55 Online
Purge and Trap OI Analytical Eclipse 4760 A946447333 As Needed Used Volatiles VOCMS56 Online
Purge and Trap OI Analytical Eclipse 4760 A039447237 As Needed Used Volatiles VOCMS57 Online
Purge and Trap OI Analytical Eclipse 4760 A041447860 As Needed Used Volatiles VOCMS58 Online
Purge and Trap OI Analytical Eclipse 4760 A946447335 As Needed Used Volatiles VOCMS59 Online
Purge and Trap PTS/EST Encon 301082903P As Needed Used Volatiles VOCGC1 Online
Purge and Trap PTS/EST Encon 269050803P As Needed Used Volatiles VOCGC2 Online
Purge and Trap PTS/EST Encon 273052803P As Needed Used Volatiles VOCGC4 Online
Purge and Trap PTS/EST Encon 156053001 As Needed Used Volatiles VOCGC5 Online
Purge and Trap PTS/EST Encon 213073102E As Needed Used Volatiles VOCGC7 Online
Purge and Trap PTS/EST Encon 271051903P As Needed Used Volatiles VOCGC10 Online
Purge and Trap PTS/EST Eclipse D719466252P As Needed Used Volatiles VOCGC12 Online
Purge and Trap PTS/EST Encon 302082903E As Needed Used Volatiles VOCGC14 Online
Purge and Trap PTS/EST Encon 280062503P As Needed Used Volatiles VOCGC15 Online
Purge and Trap PTS/EST Evolution EV577051214 As Needed Used Volatiles VOCMS6 Online
Purge and Trap PTS/EST Evolution EV504082713 As Needed Used Volatiles VOCMS4 Online
Purge and Trap PTS/EST Evolution EV831041117 As Needed Used Volatiles VOCMS13 Online
Purge and Trap PTS/EST Evolution EV642112014 As Needed Used Volatiles VOCMS21 Online
Purge and Trap PTS/EST Evolution EV643112014 As Needed Used Volatiles VOCMS22 Online
Purge and Trap PTS/EST Evolution EV618091214 As Needed Used Volatiles VOCMS23 Online
Purge and Trap PTS/EST Evolution EV594071714 As Needed Used Volatiles VOCMS30 Online
Purge and Trap PTS/EST Evolution EV832041117 As Needed Used Volatiles VOCMS44 Online
Purge and Trap PTS/EST Evolution II EV20174062121 As Needed Used Volatiles VOCMS36 Online
Description Manufacturer Model Serial Number Service
Date
Condit
ion
Location Internal
ID
Manual
Location
Analytical
Balance
Mettler XP205 1129420141 As Needed Used Wet Lab Balance 3 Online
Analytical
Balance
Mettler
Toledo
AG204 1120381348 As Needed Used Wet Lab WetBal 1 Online
Analytical
Balance
VWR 403B 5262015128 As Needed Used Wet Lab WetBa8 Online
Analytical
Balance
VWR 403B 5262015102 As Needed Used Wet Lab WetBa7 Online
Balance RADWAG WTC600 603664 2019 New Wet Lab WetBal 13 Online
Balance Scout Pro B513752877 As Needed Used Wet Lab WetBal 9 Online
Analytical
Balance
Mettler
Toledo
MS204TS/00 B820869344 As Needed Used Wet Lab WetBal 10 Online
Autoanalyzer OI Analytical FS 3100 301831056 (NH3)
251833391 (CN)
As Needed Used Wet Lab FS 3100-1 Online
Distillation Unit-
TKN/PT
Seal
Analytical
BD50/28 5146001504 2021 New Wet Lab Block D Online
Distillation Unit-
TKN/PT
Lachat
Instrument
BD40 1018420580 2022 New Wet Lab Block C Online
Autoanalyzer OI Analytical FS 3100 407831164
(NO2NO3)
403833925 (PHT)
Wet Lab FS 3100-3 Online
Autoanalyzer Lachat Quikchem 8000 A83000-1027 As Needed Used Wet Lab Lachat 2 Online
Autoanalyzer Lachat Quikchem 8000 A83000-1638 As Needed Used Wet Lab Lachat 3 Online
Autoanalyzer Lachat Quikchem 8500 60900000341 As Needed Used Wet Lab Lachat 4 Online
Autoanalyzer Lachat Quikchem 8500 60900000342 As Needed Used Wet Lab Lachat 5 Online
Autoanalyzer Lachat Quikchem 8500 70500000452 As Needed Used Wet Lab Lachat 6 Online
Draft
ENV-MAN-MTJL-0001 v03_Quality Manual
Effective Date: 8/15/2022 3:09:53 PM
COPYRIGHT © 2019-2022 Pace® Analytical Services, LLC.
Description Manufacturer Model Serial Number Service
Date
Condit
ion
Location Internal
ID
Manual
Location
Autoanalyzer-
digestor
Lachat BD-46 100700000-982 As Needed Used Wet Lab DIG1 Online
Autoanalyzer-
digestor
Lachat BD-46 1800-871 As Needed Used Wet Lab DIG1 Online
Autoanalyzer-
digestor
Lachat BD-46 1000700000-982 As Needed Used Wet Lab DIG2 Online
Autoanalyzer-
digestor
Lachat BD-46 1800-872 As Needed Used Wet Lab DIG2 Online
Autoanalyzer-
digestor
Lachat BD-40 HTLC1018420580 As Needed Used Wet Lab DIG3 Online
Automated
Titrator
Metrohm 855 titrosampler 3256 As Needed Used Wet Lab Titrando Online
Automated
Titrator
Metrohm 855 titrosampler 3315 2021 New Wet Lab Titrando Online
Automated
Titrator
Metrohm 855 titrosampler 3319 2021 New Wet Lab Titrando Online
Balance RADWAG WTC600 603642 2019 New Wet Lab WetBal 11 Online
Balance RADWAG WTC600 603657 2019 New Wet Lab WetBal 12 Online
Balance RADWAG WTC600 603639 2019 New Wet Lab WetBal 14 Online
Bomb
Calorimeter
Parr 1108 Oxygen Bomb 5424 Used Wet Lab Parr Bomb Online
Bomb
Calorimeter
Parr 1108 Oxygen Bomb 6420-1112-24696 2021 New Wet Lab Parr Bomb Online
Centrifuge Thermo ST40 41179863 As Needed Used Wet Lab Centrifuge
Online
Centrifuge Damon HNSII 23557225 As Needed Used We Lab Centrifuge Cabinet
Class “I” weights Troemner Serial # 7944 4057 As Needed Used Wet Lab Online
COD Reactor Environment
al Express
B3000 2016CODW101 As Needed Used Wet Lab COD Reactor Online
Conductivity
Meter
ORION Model 170 32470051 As Needed Used Wet Lab ATI Orion Online
Conductivity
Meter
Thermo
Fisher
Orion VersaStar V02971 As Needed Used Wet Lab Orion VS-2 Online
Discrete Analyzer Seal AQ400 141032 2017 New Wet Lab Seal 1 Online
DI Water Dionex IC Pure 42034291 As Needed Used Wet Lab Nanopure Online
Distillation Unit-
Cyanide
Environment
al Express
Distillation 1 2270 As Needed Used Wet Lab LMD1920-106 Online
Distillation Unit-
Cyanide
Environment
al Express
Distillation 2 2271 As Needed Used Wet Lab LMD1920-106 Online
Distillation Unit-
Cyanide
Environment
al Express
Distillation 3 2272 As Needed Used Wet Lab LMD1920-106 Online
Distillation Unit-
Phenol
Westco
Scientific
Model EASY-
DIST
1062 As Needed Used Wet Lab Dist 1 Online
Distillation Unit-
Phenol
Westco
Scientific
Model EASY-
DIST
1198 As Needed Used Wet Lab Dist 2 Online
Drying Oven VWR 1390 FM 501202 As Needed Used Wet Lab 103-105 Online
Drying Oven Shel Lab FX28-2 12006713 As Needed Used Wet Lab 178-182 Online
Drying Oven Shel Lab SM028-2 8041917 As Needed Used Wet Lab 178-182 Online
Drying Oven Shel Lab --As Needed Used Wet Lab 178-182 Online
Flash Point
Tester
Koehler Pensky-Martens
K16200
R07002693B As Needed Used Wet Lab Manual Cabinet
Flash Point
Tester
Koehler Pensky-Martens
K16204
R070022328D As Needed Used Wet Lab Manual Cabinet
Automated Flash
Point Ignitability
Tester
Tanaka APM-8FC 34352 2019 New Wet Lab Automated Online
Automated Flash
Point Ignitability
Tester
Tanaka APM-8FC 34394 2020 New Wet Lab Automated Online
Hot Block TDS Environment
al Express
TDS024 2017TDSW101 2018 New Wet Lab TDS Hot
Block
Cabinet
Hot Plate Cole Parmer HS19 C-P 50000073 As Needed Used Wet Lab Hot Plate Unknow
n
Draft
ENV-MAN-MTJL-0001 v03_Quality Manual
Effective Date: 8/15/2022 3:09:53 PM
COPYRIGHT © 2019-2022 Pace® Analytical Services, LLC.
Description Manufacturer Model Serial Number Service
Date
Condit
ion
Location Internal
ID
Manual
Location
Hot Plate Thermo
Fisher
Type 2200 C1707140516473 As Needed Used Wet Lab Hot Plate Unknow
n
Hot Plate Cole Parmer HS19 CP 50002676 As Needed Used Wet Lab Hot Plate Unknow
n
Hot Plate Cole Parmer HS19 CP 50002447 As Needed Used Wet Lab Hot Plate Unknow
n
Hot Plate Cole Parmer HS19 CP 50002557 As Needed Used Wet Lab Hot Plate Unknow
n
Ion
Chromatograph
Dionex ICS-2000 6050731 As Needed Used Wet Lab IC5 Online
Ion
Chromatograph
Dionex ICS 1500 8100010 As Needed Used Wet Lab IC6 Online
Ion
Chromatograph
Dionex ICS 2000 8090820 As Needed Used Wet Lab IC8 Online
Ion
Chromatograph
Dionex ICS 2100 10060822 As Needed Used Wet Lab IC9 Online
Ion
Chromatograph
Dionex ICS 2100 10091285 As Needed Used Wet Lab IC10 Online
Ion
Chromatograph
Dionex ICS 2100 11012204 As Needed Used Wet Lab IC11 Online
Ion
Chromatograph
Dionex ICS 2100 12020460 As Needed Used Wet Lab IC12 Online
Ion
Chromatograph
Thermo
Fisher
ICS 1600 13031204 As Needed Used Wet Lab IC13 Online
Ion
Chromatograph
Thermo
Fisher
ICS-2100 15030082 As Needed Used Wet Lab IC14 Online
Ion
Chromatograph
Thermo
Fisher
ICS-2100 15071973 As Needed Used Wet Lab IC15 Online
Ion
Chromatograph
Thermo
Fisher
ICS-2100 15071973 As Needed Used Wet Lab IC16 Online
Ion
Chromatograph
Thermo
Fisher
(1) ICS-
1600
15110462 As Needed Used Wet Lab IC17 Online
Ion
Chromatograph
Thermo
Fisher
ICS-2100 15120139 As Needed Used Wet Lab IC18 Online
Ion
Chromatograph
Thermo
Fisher
Integrion 16070510 As Needed Used Wet Lab IC19 Online
Ion
Chromatograph
Thermo
Fisher
Integrion 16090734 As Needed Used Wet Lab IC20 Online
Ion Chromato
Ion
Thermo
Fisher
Integrion 19050436 2019 New Wet Lab IC21 Online
Ion
Chromatograph
Thermo
Fisher
Integrion 19040421 2019 New Wet Lab IC22 Online
Ion
Chromatograph
Thermo
Fisher
Integrion 19050752 2019 New Wet Lab IC23 Online
Ion
Chromatograph
Thermo
Fisher
Integrion 19050751 2019 New Wet Lab IC24 Online
Muffle Furnace Thermolyne 30400 23231 As Needed Used Wet Lab FURNACE Online
Muffle Furnance Cole Parmer CE3749 As Needed Used Wet Lab FURNACE Online
ORP Meter YSI ORP15 JC000114 As Needed Used Wet Lab ORP Online
pH Meter Fisher AB15 AB92329028 As Needed Used Wet Lab AB 15+Online
pH Meter Orion 410A 58074 As Needed Used Wet Lab Orion Online
pH Meter Thermo
Fisher
Orion VersaStar V00659 As Needed Used Wet Lab Orion VS-1 Online
pH Meter Thermo
Fisher
Orion Starfall 1 J13992 As Needed Used Wet Lab PH1 Online
pH Meter Thermo
Fisher
Orion Star A222 K12005 2018 New Wet Lab PH Online
pH Meter Thermo
Fisher
Orion Star A111 J21101 As Needed Used Wet Lab PH Online
pH Meter Thermo
Fisher
Orion Star A111 J21983 2019 New Wet Lab pH Online
Refrigerated
Recirculator
Polyscience Recirculator 1282 As Needed Used Wet Lab Recirculator 1 Online
Draft
ENV-MAN-MTJL-0001 v03_Quality Manual
Effective Date: 8/15/2022 3:09:53 PM
COPYRIGHT © 2019-2022 Pace® Analytical Services, LLC.
Description Manufacturer Model Serial Number Service
Date
Condit
ion
Location Internal
ID
Manual
Location
Refrigerated
Recirculator
Polyscience Recirculator 1608 As Needed Used Wet Lab Recirculator 2 Online
Shaker GlasCol 099A LC1012 11325052 As Needed Used Wet Lab Shaker Online
SimpleDist Env. Express SC154 8940CECW3871 As Needed Used Wet Lab SimpDist1 Online
SimpleDist Env. Express SC155 9062CECW3952 As Needed Used Wet Lab SimpDist2 Online
SimpleDist Env. Express SC156 9062CECW3955 As Needed Used Wet Lab SimpDist3 Online
SimpleDist Env Express MDI 2019MDISW159 2019 New Wet Lab SimpD4 Online
SimpleDist Env Express MDI 2019MDISW162 2019 New Wet Lab SimpD 5 Online
Spectrophotomet
er
Hach DR6000 1646676 As Needed Used Wet Lab DR6000-1 Online
Spectrophotomet
er
Hach DR6000 1646781 As Needed Used Wet Lab DR6000-2 Online
Spectrophotomet
er
Hach DR6000 1894098 2019 New Wet Lab DR6000-3 Online
Spectrophotomet
er
Hach Dr6000 1893736 2022 New Wet Lab DECSP02 Online
Stir Base Env. Express STIR 2019 STIR132 2019 New Wet Lab STIR Online
TOC Analyzer Shimadzu Model TOC-VWS 39830572 As Needed Used Wet Lab TOC2 Online
TOC Analyzer Shimadzu TOC-VCPH H51304435 As Needed Used Wet Lab TOC3 Not in
Sevice
TOC Analyzer Shimadzu TOC-L H54335232035 As Needed Used Wet Lab TOC5 Online
TOC Analyzer Shimadzu TOC H51725600306 As Needed Used Wet Lab TOC6 Online
TOC Analyzer EST TE Xplorer 2019.154 2019 New Wet Lab TOC8 Online
TOC Analyzer Shimadzu TOC-L H54215000551 2021 Used Wet Lab TOC10 Online
TOX Analyzer EST TE Xplorer 2017.287 2017 New Wet Lab TOX5 Online
TOX Analyzer EST TE Xplorer 2017.286 2017 New Wet Lab TOX6 Online
TOX Analyzer EST TE Xplorer 2015-184 2015 New Wet Lab TOX3 Online
TOX Analyzer EST TE Xplorer 2016202 2016 New Wet Lab TOX4 Online
Turbidimeter Hach TL2300 2017070C0008 2018 New Wet Lab TURB1 Online
Description Manufacturer Model Serial Number Service
Date
Condit
ion
Location Internal
ID
Manual
Location
Chemchek KPA-
11 Kinetic
Phosphorescence
Analyzer w/
Gilson Sample
Changer and
Gilson Dilutor
401 Syringe Pump
Chemchek KPA-11 1418986;
649025031; 91-
5050024
As Needed Used Rad Lab At the
Instrument
Canberra 2404
Alpha/Beta
Counter
Canberra 2404 1090352; 988600/
787196; 488584
As Needed Used Rad Lab At the
Instrument
Packard Tri-Carb
2200CA Liquid
Scintillation
Counter
Packard 2200CA 102180 As Needed Used Rad Lab At the
Instrument
Canberra LB4100
Alpha/Beta
Counter
Canberra LB4100U2 1300001; 1300002;
1300000; 117
As Needed Used Rad Lab At the
Instrument
Canberra Genie
2000 Alpha
Spectrometer
System
Canberra Genie 2000 See Description As Needed Used Rad Lab At the
Instrument
Canberra Genie
2000 Gamma
Spectrometer
System
Canberra Genie 2000 See Description Clean
Chambers
monthly,
Vacuum
pump-6
months.
As needed.
Used Rad Lab At the
Instrument
Draft
ENV-MAN-MTJL-0001 v03_Quality Manual
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COPYRIGHT © 2019-2022 Pace® Analytical Services, LLC.
Description Manufacturer Model Serial Number Service
Date
Condit
ion
Location Internal
ID
Manual
Location
LSC 8000 Liquid
Scintillation
Counter
Hitachi LSC-8000 GR30025119 As Needed New Rad Lab At the
Instrument
Hot Plate Presto 703016 NA As Needed Used Rad Lab G1 Online
Hot Plate Presto NA NA As Needed Used Rad Lab G2 Online
Hot Plate Presto 703016 NA As Needed Used Rad Lab G3 Online
Hot Plate Bella TSK-2470P NA As Needed Used Rad Lab G4 Online
Hot Plate Bella TSK-2470P NA As Needed Used Rad Lab G5 Online
Hot Plate Presto TSK-2470P NA As Needed Used Rad Lab G6 Online
Hot Plate Presto 703016 NA As Needed Used Rad Lab G7 Online
Hot Plate Bella TSK-2470P NA As Needed Used Rad Lab G8 Online
Hot Plate Presto 703016 NA As Needed Used Rad Lab G9 Online
Hot Plate Mainstays NA NA As Needed Used Rad Lab G10 Online
Hot Plate Mainstays NA NA As Needed Used Rad Lab G11 Online
Furnace Fisher
Scientific
550-126 902NOO12 As Needed Used Rad Lab M1 Online
Furnace Barnstead FB1415M 7.46951E+11 As Needed Used Rad Lab M2 Online
Centrifuge Beckman TJ-06 96006 As Needed Used Rad Lab C1 Rad Lab
Centrifuge Beckman TJ-06 9A010 As Needed Used Rad Lab C2 Rad Lab
Centrifuge Beckman TJ-06 8953 As Needed Used Rad Lab C3 Rad Lab
Centrifuge Fisher
Scientific
ST-40 42502680 As Needed Used Rad Lab C4 Rad Lab
Hot Water Bath Oster NA NA As Needed Used Rad Lab HB1 Online
Hot Water Bath Mainstays NA NA As Needed Used Rad Lab HB2 Online
Hot Water Bath Sunbeam
Products
CKSTR51B-VHD-
D
192847 As Needed Used Rad Lab HB3 Online
Sonicator CD FCC
RoHS
PS-30A 20150720 As Needed Used Rad Lab So1 Online
Hot Plate Troemner,
LLC
984VWOAHPUSS 171027003 As Needed Used Rad Lab HP1 Online
Hot Plate Troemner,
LLC
984VWOAHPUSS 161026002 As Needed Used Rad Lab HP2 Online
Hot Plate Troemner,
LLC
984VWOAHPUSS 161026001 As Needed Used Rad Lab HP3 Online
Hot Plate Troemner,
LLC
984VWOAHPUSS 160927002 As Needed Used Rad Lab HP4 Online
Shaker Eserbach NA NA As Needed Used Rad Lab Sh1 Online
Shaker NA 6000 NA As Needed Used Rad Lab Sh2 Online
Hot Plate/Stirrer NA NA NA As Needed Used Rad Lab St1 Online
Hot Plate/Stirrer Labline
Insruments
1287 NA As Needed Used Rad Lab St2 Online
Hot Plate/Stirrer Labline
Instruments
1287 3055447 As Needed Used Rad Lab St3 Online
Hot Plate/Stirrer NA NA NA As Needed Used Rad Lab St4 Online
Hot Plate/Stirrer NA NA NA As Needed Used Rad Lab St5 Online
Hot Plate/Stirrer NA NA NA As Needed Used Rad Lab St6 Online
Hot Plate/Stirrer NA NA NA As Needed Used Rad Lab St7 Online
Hot Plate/Stirrer NA NA NA As Needed Used Rad Lab St8 Online
Hot Plate/Stirrer NA NA NA As Needed Used Rad Lab St9 Online
Hot Plate/Stirrer NA NA NA As Needed Used Rad Lab St10 Online
Hot Plate/Stirrer Labline
Instruments
1268 NA As Needed Used Rad Lab St11 Online
Hot Plate/Stirrer Labline
Instruments
1268 NA As Needed Used Rad Lab St12 Online
Hot Plate/Stirrer Labline
Instruments
1268 8039816 As Needed Used Rad Lab St13 Online
Hot Plate/Stirrer Labline
Instruments
1268 0185 As Needed Used Rad Lab St14 Online
Hot Plate/Stirrer SYMA HJ6A NA As Needed New Rad Lab St15 Online
Hot Plate/Stirrer SYMA HJ6A NA As Needed New Rad Lab St16 Online
Hot Plate/Stirrer SYMA HJ6A NA As Needed New Rad Lab St17 Online
Hot Plate/Stirrer SYMA HJ6A NA As Needed New Rad Lab St18 Online
Oven Binder NA NA As Needed Used Rad Lab O1 Online
Draft
ENV-MAN-MTJL-0001 v03_Quality Manual
Effective Date: 8/15/2022 3:09:53 PM
COPYRIGHT © 2019-2022 Pace® Analytical Services, LLC.
Description Manufacturer Model Serial Number Service
Date
Condit
ion
Location Internal
ID
Manual
Location
Oven Shel Lab 1326 5057405 As Needed Used Rad Lab O2 Online
Sealer Automatic
Canning
NA 3108 As Needed Used Rad Lab S1 Rad Lab
Grinder Straus Co. 4E NA As Needed Used Rad Lab GR1 Rad Lab
Grinder Arthur H.
Thomas Co.
NA 4352 As Needed Used Rad Lab GR2 Rad Lab
Tumbler US Stoneware NA CN12005 As Needed Used Rad Lab T1 Rad Lab
Tumbler US Stoneware NA CN32108 As Needed Used Rad Lab T2 Rad Lab
Balance RADWAG PS360R2 530077 As Needed Used Rad Lab RADBAL
1
Rad Lab
Balance RADWAG PS4500R2 544404 As Needed Used Rad Lab RADBAL
2
Rad Lab
Balance RADWAG AS60/220R2 415543 As Needed Used Rad Lab RADBAL
3
Rad Lab
Balance RADWAG PS4500R2 544401 As Needed Used Rad Lab RADBAL
4
Rad Lab
Pipettor/Repeate
r
RAININ EDP3-PLUS C040040E Quarterly Used Rad Lab E-31 Rad
Lab/Online
Pipettor/Repeate
r
RAININ EDP3-PLUS K0203177E Quarterly Used Rad Lab E-44 Rad
Lab/Online
Pipettor/Repeate
r
RAININ EDP3 J0400734E Quarterly Used Rad Lab E-33 Rad
Lab/Online
Pipettor/Repeate
r
RAININ EDP3-PLUS H0300753E Quarterly Used Rad Lab E-63 Rad
Lab/Online
Pipettor/Repeate
r
RAININ EDP3-PLUS A00978 Quarterly Used Rad Lab E-41 Rad
Lab/Online
Pipettor/Repeate
r
RAININ EDP3-PLUS J0400699E Quarterly Used Rad Lab E-43 Rad
Lab/Online
Pipettor/Repeate
r
RAININ EDP3-PLUS J0300147E Quarterly Used Rad Lab E-54 Rad
Lab/Online
Pipettor/Repeate
r
RAININ EDP3-PLUS G0200223E Quarterly Used Rad Lab E-32 Rad
Lab/Online
Pipettor/Repeate
r
RAININ EDP3-PLUS H0000585E Quarterly Used Rad Lab E-53 Rad
Lab/Online
Pipettor/Repeate
r
RAININ EDP3-PLUS B0200477E Quarterly Used Rad Lab E-42 Rad
Lab/Online
Pipettor/Repeate
r
OXFORD MACRO SET NA Quarterly Used Rad Lab 102 Rad
Lab/Online
Pipettor/Repeate
r
OXFORD NA Quarterly Used Rad Lab 130 Rad
Lab/Online
Pipettor/Repeate
r
Ward Science 2.5-30 NA Quarterly Used Rad Lab RP-1 Rad
Lab/Online
Pipettor/Repeate
r
RAININ EDP3-PLUS F200510E Quarterly Used Rad Lab E-34 Rad
Lab/Online
Pipettor/Repeate
r
RAININ EDP3-PLUS D1100091E Quarterly Used Rad Lab E-64 Rad
Lab/Online
Survey Meter 9 79445 Annually Used Rad Lab Rad Lab
Survey Meter 3 156503 Annually Used Rad Lab Rad Lab
Survey Meter 12 88002 Annually Used Rad Lab Rad Lab
Survey Meter 3-98 71211 Annually Used Rad Lab Rad Lab
Survey Meter 3-98 455984 Annually Used Rad Lab Rad Lab
Survey Meter 3 292175 Annually Used Rad Lab Rad Lab
Survey Meter 3 292202 Annually Used Rad Lab Rad Lab
Survey Meter 177 287820 Annually Used Rad Lab Rad Lab
Survey Meter 2221 172021 Annually Used Rad Lab Rad Lab
Survey Meter 19 156438 Annually Used Rad Lab Rad Lab
Survey Meter 9 74528 Annually Used Rad Lab Rad Lab
Survey Meter 3 156232 Annually Used Rad Lab Rad Lab
Survey Meter 3 156193 Annually Used Rad Lab Rad Lab
Survey Meter 3 56439 Annually Used Rad Lab Rad Lab
Survey Meter 12 63765 Annually Used Rad Lab Rad Lab
Survey Meter 177 96337 Annually Used Rad Lab Rad Lab
Survey Meter 12 47797 Annually Used Rad Lab Rad Lab
Draft
ENV-MAN-MTJL-0001 v03_Quality Manual
Effective Date: 8/15/2022 3:09:53 PM
COPYRIGHT © 2019-2022 Pace® Analytical Services, LLC.
Description Manufacturer Model Serial Number Service
Date
Condit
ion
Location Internal
ID
Manual
Location
Survey Meter 12 87918 Annually Used Rad Lab Rad Lab
Survey Meter 2221 154201 Annually Used Rad Lab Rad Lab
Survey Meter 19 499190 Annually Used Rad Lab Rad Lab
Survey Meter 19 156468 Annually Used Rad Lab Rad Lab
Survey Meter 3-98 155387 Annually Used Rad Lab Rad Lab
Survey Meter 3 156193 Annually Used Rad Lab Rad Lab
Draft
ENV-MAN-MTJL-0001 v03_Quality Manual
Effective Date: 8/15/2022 3:09:53 PM
COPYRIGHT © 2019-2022 Pace® Analytical Services, LLC.
Description Manufacturer
e
Model Serial Number Service
date
Conditi
on
Location Internal
ID
Manual
Location
Centrifuge Eppendorf 5424R 5404IR839716 As needed New PCR PCR Lab
Centrifuge Thermo
Scientific
Sorvall Legend
Micro 21R
42930526 As needed New PCR PCR Lab
Galaxy Tablet
with PLatr
Samsung SM-T510 R52MA0T1C5E As needed New PCR PCR Lab
Heat Block Thermo
Scientifc
Dry bath Standard
1 Blck 100-120V
KABT70001011 As needed New PCR PCR Lab
Isotemp Large
Oven
Fisherbrand 3511FSQ 300403777 As needed New PCR PCR Lab
Mini Centrifuge Fisherbrand SPROUT PLUS HSG04861 As needed New PCR PCR Lab
Mini Centrifuge Fisherbrand SPROUT PUS HSG04753 As needed New PCR PCR Lab
Mini Vortex
Mixer
Fisherbrand Mini Vortex Mixer
(Variable Speed)
200020151 As needed New PCR PCR Lab
Mini Vortex
Mixer
Fisherbrand Mini Vortex Mixer
(Variable Speed)
200020151 As needed New PCR PCR Lab
Minus 80 Freezer SCIENTEMP 86-01A S8008781 As needed New PCR PCR Lab
Precisiom CIR 89
Water Bath
Thermo
Scientific
TSCIR89 300399766 As needed New PCR PCR Lab
Refrigerator Frigidaire FRT18L4JW5 BA92344749 As needed PCR PCR Lab
Repeater Pipette Eppendorf Repeater E3 N296671 As needed PCR PCR Lab
Repeater Pipette Eppendorf Repeater E4 H40109J As needed PCR PCR Lab
RT-PCR Machine Applied
Biosystems
by Thermo
Scientific
QuantStudio5 272531538 As needed New PCR PCR Lab
RT-PCR Machine Applied
Biosystems
by Thermo
Scientific
QuantStudio7 278872930 As needed New PCR PCR Lab
Refrigerator Danbury
Designer
DAR110A1WDD 4320043102086 As needed New PCR PCR Lab
Oven Quincy Lab
Inc
10-100 I11-2454 As needed Used PCR PCR Lab
Sorvall X Pro
Centrifuge
ThermoFishe
r Scientific
SorvallX4R Pro-
MD
42632360 As needed New PCR PCR Lab
UPS (Surge
Protector/Power
Backup
CyberPower CP1500PFCLCDa CXXJY2002934 As needed New PCR PCR Lab
UPS (Surge
Protector/Power
Backup
CyberPower CP1500PFCLCD CXXJY2002934 As needed New PCR PCR Lab
Incubator Fisherbrand Isotemp 300403777 As needed New PCR PCR Lab
Plate Shaker Fisherbrand 88861023 K4CF61023014 As needed New PCR PCR Lab
Draft
ENV-MAN-MTJL-0001 v03_Quality Manual
Effective Date: 8/15/2022 3:09:53 PM
COPYRIGHT © 2019-2022 Pace® Analytical Services, LLC.
8.0 ADDENDUM: PROGRAM REQUIREMENTS
Section 8.0 provides additional requirements the locations covered by this manual are required to follow
when performing work under the program. Only requirements that are not covered by the main body of
the manual are listed in addendum.
8.1 DoD/DOE
PAS-Mt. Juliet maintains accreditation for DoD/DoE Environmental Laboratory Approval
Program (ELAP)
This addendum outlines additional policies and processes established by this laboratory to maintain
compliance with DoD/DOE program specific requirements as outlined in the DoD/DOE
Consolidated Quality Systems Manual (QSM) for Environmental Laboratories. The QSM
incorporates ISO/IEC 17025 and the TNI Standard and includes additional program-specific
requirements for laboratories that perform analytical testing services for DoD and DOE, and which
must be followed for DoD / DOE projects.
Section 4.2.5: Supporting Documents
In addition to the requirements specified in Section 4.2.5, technical SOPs used for DoD/DOE
testing must also include instructions for equipment and instrument maintenance, computer
software/hardware, and troubleshooting.
The review frequency for technical SOPs used for DoD/DOE testing is annual, instead of every 2
years.
Section 4.4: Review of Analytical Service Requests
If the DoD/DOE customer requests a statement of conformity, the standard used for the decision
rule must be communicated to and agreed on with the customer and identified in the final test report.
Laboratory requests to deviate from the requirements specified in the DoD/DOE QSM must be
requested on a project-basis and include technical justifications for the deviation. These requests are
submitted to and approved by the DoD/DOE project chemist or contractor, however name, in
addition to the PAS client.
For DoD / DOE projects, will also seek clarification from the customer when the customer has
requested an incorrect, obsolete, or improper method for the intended use of data; the laboratory
needs to depart from its test method SOP in order to meet project-specific data quality objectives;
information in project planning documents is missing or is unclear,
Section 4.5: Subcontracting
In addition to written client approval of any subcontractor for testing, the customer is notified of
the laboratory’s intent to use a subcontractor for any management system element (such as data
review, data processing, project management or IT support) and consent for subcontracting is
obtained approved in writing by the DoD/DOE customer and record of consent kept in the project
record.
Section 4.6: Purchasing and Supplies
The laboratory procedure for records of receipt of materials and supplies used in testing also include
a specification to record the date opened (DOE only).
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ENV-MAN-MTJL-0001 v03_Quality Manual
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COPYRIGHT © 2019-2022 Pace® Analytical Services, LLC.
Section 4.9.3: Nonconforming Work
The laboratory’s procedure for client notification includes the 15-business day DoD /DOE
timeframe for notification of the problem and the 30-business day timeframe for submission of the
corrective action plan or corrective actions taken. This procedure also includes the DoD/DOE
requirement for AB notification of discovery.
Section 4.13: Control of Records
Technical Records: The laboratory’s procedure for logbooks includes measures to prevent the
removal of or addition of pages to the logbook (applies to both hardcopy and electronic). Hardcopy
logbooks are version controlled, pre-numbered and bound. Initials and entries are signed or initialed
and dated by the person making the entry and the entry is made at the time the activity is performed
and in chronological order. Each page of the logbook must be closed by the last person making the
entry on the page. Closure is recorded by the initial and date of the person making the last entry.
Section 5.4.5.3.3: Limit of Detection
For DoD/DOE the LOD is an estimate of the minimum amount of an analyte that can be reliably
detected by an analytical process. For clarification, the LOD is the analyte concentration necessary
to distinguish its presence from its absence. The LOD may be used as the lowest concentration for
reliably reporting a non-detect (ND). The LOD is specific to each suite of analyte, matrix, and
method including sample preparation.
After each DL determination, the laboratory establishes the LOD by spiking a quality system matrix
at a concentration of least 2X but no greater than 4X the DL (i.e., 2X DL ≤ LOD Spike ≤ 4X DL).
The spike concentration establishes the LOD and the concentration at which the LOD is verified.
The LOD is established during method validation and after major changes to the analytical system
or procedure that affects sensitivity of analysis or how the procedure is performed.
An LOD study is not required for any component for which spiking solutions or quality control
samples are not available. Additionally, an LOD study is not required if the laboratory does not
report data below the LOQ.
The LOD must be verified on a quarterly basis. Each preparation method listed on the scope of
accreditation must have quarterly LOD verifications; however, verification of all possible
combinations of preparation and clean-up techniques is not required. Where LOD verifications are
not performed on all combinations, the LOD verification is based on the worst-case combination
(preparation method with all applicable cleanup steps).
The laboratory’s procedure for LOD determination and verification is detailed in SOP ENV-SOP-
MTJL-0016 Method Detection Limits (MDL), Limits of Detection (LOD) and Limits of Quantitation (LOQ)
and ENV-SOP-MTJL-0340 Radiochemistry Method Performance Criteria.
Section 5.4.5.3.4: Limit of Quantitation
For DoD/DOE, the LOQ is established for each analyte-matrix-method combination, including
surrogates. When an LOD is determined or verified by the laboratory, the LOQ must be above the
LOD [DL<LOD<LOQ].
At a minimum, the LOQ must be verified quarterly; however, verification of all possible
combinations of preparation and clean-up techniques is not required. Where LOQ verifications are
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COPYRIGHT © 2019-2022 Pace® Analytical Services, LLC.
not performed on all combinations, the LOQ verification on the worst-case combination
(preparation method with all applicable cleanup steps).
The laboratory’s procedure for LOQ determination and verification is detailed in laboratory SOP
ENV-SOP-MTJL-0016 Method Detection Limits (MDL), Limits of Detection (LOD) and Limits of
Quantitation (LOQ) and ENV-SOP-MTJL-0340 Radiochemistry Method Performance Criteria.
Section 5.4.7: Control of Data
The laboratory will assure LIMS passwords are changed at least once per year.
An audit of the LIMS will be incorporated into the laboratory’s annual internal audit schedule.
The laboratory will have procedures in place to notify DoD/DOE customers of changes to LIMS
software or hardware configurations that may impact the customer’s integrity of electronic data
Section 5.9.1: Quality Control
For DoD/DOE, storage blanks are essential QC to monitor the storage of samples for volatile
organic analysis (VOA). The SOP for storage of VOA samples must include a contamination
monitoring program based on the performance of storage blanks. (See QSM 5.3.3)
Section 5.8.5: Sample Disposal
For DOE projects, the record of disposal must also include how the sample was disposed and the
name of the person that performed the task.
Appendix E: Support Equipment Calibration
Mechanical Volumetric Pipette: In addition to the quarterly verification check, pipettes used for
DoD/DOE projects are checked daily before use using the same procedure and criteria specified
for the quarterly check.
Water Purification System: The performance of the water purification system is checked daily prior
to use in accordance with SOP ENV-SOP-MTJL-0366 Reagent Water Quality.
Radiological Survey Equipment: The performance of the radiological survey equipment is checked
daily prior to use in accordance with SOP ENV-SOP-MTJL-0344 Radiation and Contamination Surveys.
Additional: (DOE): Section 6.0 of the QSM outlines additional management system requirements
for the management of hazardous and radioactive materials management and health and safety
practices. The laboratory, if approved for DOE, will consult with the PAS Health and Safety Director
to establish plans, policies and procedures that conform to these comprehensive specifications and
incorporate these documents into the QMS.
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8.2 ADDENDUM: AIHA-LAP, LLC
Section 4.1.5.4: Confidentiality
While the laboratory does not typically make client information public, the customer will be informed
in advance if the laboratory intends to place any client-identifying information in the public domain.
Information about the customer obtained from sources other than the customer (e.g., complainant,
regulators) will remain confidential between the customer and the laboratory. The source of the
information will remain confidential to the laboratory and will not be shared with the customer,
unless agreed by the source.
Personnel, including any committee members, contractors, personnel of external bodies, or
individuals acting on the laboratory’s behalf, shall keep confidential all information obtained or
created during the performance of laboratory activities, except as required by law.
All personnel of the laboratory, either internal or external, that could influence the laboratory
activities shall act impartially, be competent and work in accordance with the laboratory’s
management system.
Section 4.2.1.2: Risk and Opportunity Assessment
Actions taken to address risks and opportunities shall be proportional to the potential impact on the
validity of laboratory results.
Section 4.3.1: Document Control – General
All documentation, processes, systems, records, related to the fulfilment of the requirements of
ISO/IEC 17025 are included in, referenced from, or linked to the management system. All
personnel involved in laboratory activities have access to the parts of the management system
documentation and related information that are applicable to their responsibilities.
Section 4.4: Analytical Service Request, Tender, and Contract Review
If a contract is amended after the work has commenced, the contract review shall be repeated and
any amendments shall be communicated to all affected personnel.
Section 4.13.2.3: Error Correction
Amendments to technical records can be tracked to previous versions or to original observations.
Both the original and amended data and files are retained as applicable, including the date of
alteration, an indication of the altered aspects and the personnel responsible for the alterations.
Section 4.14.1: Internal Audit
Quality System Audits: A review of all management system requirements of ISO/IEC 17025
and any other regulatory or applicable policy document (e.g., AIHA-LAP, LLC). These
audits are also performed annually per a pre-determined schedule.
Section 5.5.2: Calibration
Laboratory staff performing in-house calibrations and verifications shall have received documented
training.
Section 5.5.7: Calibration Status
Measuring equipment shall be calibrated when:
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The measurement accuracy or measurement uncertainty affects the validity of the reported
results, and/or
Calibration of the equipment is required to establish the metrological traceability of the
reported results
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8.3 ADDENDUM: SOP Review
DoD and drinking water SOPs are reviewed annually.
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8.4 ADDENDUM: RADIOLOGICAL REQUIREMENTS
8.4.1 Estimate of Analytical Uncertainty
Radiological tests often report uncertainty and the manner in which it is derived are in
accordance with Multi-Agency Radiological Laboratories Analytical Protocols Manual
(MARLAP) and Evaluation of Measurement Data – Guide to the Expression of Uncertainty
in Measurement (GUM). The means by which these criteria are applied can be found in the
method SOPs.
8.4.2 Radiological Equipment Calibration
Radiological calibrations may follow one of several methodologies based on technology of
the counting; these can include efficiency curves, energy calibrations and quench curves. The
various calibrations should ensure that the range chosen encompasses the activities expected
in the client samples.
Radiological Equipment should be calibrated at the appropriate frequency and whenever the
equipment undergoes maintenance. In the case of liquid scintillation counters the equipment
shall be recalibrated when a significant move has taken place.
Calibrations can vary with equipment; in the case of gas flow proportional counters standards
that range the expected residue range for gross alpha and beta shall be used, with efficiency
curves developed to encompass the range of client sample residues. Any samples outside of
this range shall be evaluated and the aliquot changed to accommodate the curve if necessary.
Beta emitters, or isotopes that are shown to have less than a 2% efficiency change with residue
that are known to not experience self attenuation may be calibrated by using a least 3
standards of known activity and comparing the efficiency results to ensure all agree to a
relative standard deviation of less than 5%.
Quench factors for liquid scintillation counters shall be prepared by adding varied amounts
of quenching agent. Any sample displaying a quench factor outside of the curve shall be
evaluated. If the quench factors are shown to not vary in efficiency by greater than 2% then
an efficiency calibration can be established using at least 3 standards of known activity and
comparing the efficiency results to ensure all agree to a relative standard deviation of less
than 5%.
Cross talk factors must also be evaluated when samples are known to contain more than one
beta or an alpha and beta emitter.
All detectors must pass various daily tests depending upon the technology. The criteria of
these various tests should be known to the analyst. Any detector that does not pass the daily
check must be re-checked.
If the daily test fails a second time the detector must be taken out of service for that day. Any
detector that fails two daily checks must be evaluated and serviced if required. In most
instances two passing daily checks are required to put a detector back into service.
8.4.3 Matrix Spike/Matrix Spike Duplicate (MS/MSD)
For radiochemical analyses, tests that do not incorporate the use of a carrier or tracer for
yield assessment must contain an associated MS and MSD (or sample duplicate) using the
same matrix collected for the specific DOD project. Gamma spectroscopy analyses are
excluded from the MS/MSD requirement as the test does not require chemical processing of
samples for analysis
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8.5 ADDENDUM: QUALITY CONTROL CALCULATIONS
PERCENT RECOVERY (%REC)
%𝑅𝐸𝐶=
(𝑀𝑆𝐶𝑜𝑛𝑐‒𝑆𝑎𝑚𝑝𝑙𝑒𝐶𝑜𝑛𝑐)
𝑇𝑟𝑢𝑒𝑉𝑎𝑙𝑢𝑒∗100
NOTE: The SampleConc is zero (0) for the LCS and Surrogate Calculations
PERCENT DIFFERENCE (%D)
%𝐷=
𝑀𝑒𝑎𝑠𝑢𝑟𝑒𝑑𝑉𝑎𝑙𝑢𝑒‒𝑇𝑟𝑢𝑒𝑉𝑎𝑙𝑢𝑒
𝑇𝑟𝑢𝑒𝑉𝑎𝑙𝑢𝑒∗100
where:
TrueValue = Amount spiked (can also be the CF or RF of the ICAL Standards)
Measured Value = Amount measured (can also be the CF or RF of the CCV)
PERCENT DRIFT
%𝑫𝒓𝒊𝒇𝒕=
𝑪𝒂𝒍𝒄𝒖𝒍𝒂𝒕𝒆𝒅𝑪𝒐𝒏𝒄𝒆𝒏𝒕𝒓𝒂𝒕𝒊𝒐𝒏‒𝑻𝒉𝒆𝒐𝒓𝒆𝒕𝒊𝒄𝒂𝒍𝑪𝒐𝒏𝒄𝒆𝒏𝒕𝒓𝒂𝒕𝒊𝒐𝒏
𝑻𝒉𝒆𝒐𝒓𝒆𝒕𝒊𝒄𝒂𝒍𝑪𝒐𝒏𝒄𝒆𝒏𝒕𝒓𝒕𝒊𝒐𝒏∗𝟏𝟎𝟎
RELATIVE PERCENT DIFFERENCE (RPD)
𝑅𝑃𝐷=
|(𝑅1 ‒𝑅2)|
(𝑅1 +𝑅2)/2 ∗100
where:
R1 = Result Sample 1
R2 = Result Sample 2
CORRELATION COEFFICIENT (R)
CorrCoeff =
With: N Number of standard samples involved in the calibration
i Index for standard samples
Wi Weight factor of the standard sample no. i
Xi X-value of the standard sample no. i
X(bar) Average value of all x-values
Yi Y-value of the standard sample no. i
Y(bar) Average value of all y-values


N
i
iii YYXXW
1
)(*)(*






N
i
ii
N
i
ii YYWXXW
1
2
1
2 )(**)(*
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CALIBRATION FACTOR (CF)
CF =
A𝑠
𝐶𝑠
where:
As = Average Peak Area over the number of peaks used for quantitation
Cs = Concentration of the analyte in the standard
RESPONSE FACTOR (RF)
)Area)(.(Conc
)Area)(.(Conc=RF
IStdanalyte
AnalyteIStd
where:
As = Response for analyte to be measured
Ais = Response for the internal standard
Cis = Concentration of the internal standard
Cs = Concentration of the analyte to be measured
LINEAR CALIBRATION MODEL
𝑦=𝑚𝑥+𝑏
where:
m = Slope of the line
b = The y intercept
QUADRATIC CALIBRATION MODEL
𝑦=𝑎𝑥2 +𝑏𝑥+𝑐
where:
c = The y intercept
STANDARD DEVIATION (S)
𝑺=
𝒏
∑
𝒊=𝟏
(𝑿𝒊‒𝑿)𝟐
(𝒏‒𝟏)
where:
n = number of data points
Xi = individual data point
X = average of all data points
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AVERAGE (X)
𝑋=
𝑖
∑
𝑛=1
𝑋𝑖
𝑛
where:
n = number of data points
Xi = individual data point
RELATIVE STANDARD DEVIATION (RSD)
𝑅𝑆𝐷=
𝑆
𝑋∗100
where:
S = Standard Deviation of the data points
X = average of all data points
PERCENT ERROR
%𝐸𝑟𝑟𝑜𝑟=
𝑥𝑖‒𝑥'𝑖
𝑥𝑖
∗100
where:
x´i = Measured amount of analyte at calibration level i
xi = True amount of analyte at calibration level i
RELATIVE STANDARD ERROR (RSE)
𝑅𝑆𝐸=100 ×
𝑛
∑
𝑖=1
[𝑥'𝑖‒𝑥𝑖
𝑥𝑖]2
(𝑛‒𝑝)
where:
xi = True amount of analyte at calibration level i
x´i = Measured amount of analyte at calibration level i
p = Number of terms in fitting equation (Average = 1, Linear = 2, Quadratic = 3)
n = Number of calibration points
AVERAGE RESPONSE 1/X FOR MASS HUNTER INSTRUMENTS
𝑅𝐹
1
𝑥=
𝑛
∑
𝑠=1
1
𝐶𝑠
∑𝑛
𝑠=1((𝐴𝑠∗𝐶𝑖𝑠)
𝐴𝑖𝑠∗𝐶𝑠)
where:
As = Response for analyte to be measured
Ais = Response for the internal standard
Cis = Concentration of the internal standard
Cs = Concentration of the analyte to be measured
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MINIMUM DETECTABLE ACTIVITY (MDA)
The MDA is used for radiochemical analysis and is calculated with the following equations:
MDA with Blank Population

3.29 ∗𝑆𝑏
𝐾𝑇𝑠
+
3
𝐾𝑇𝑆
MDA =
Where:
K = E × V × R × Y × F × 2.22
E = efficiency
V = sample volume
R = tracer recovery
Y = gravimetric carrier recovery
F = ingrowth or decay factor
2.22 = conversion from dpm to pCi
Ts = count time of sample in minutes
Sb = standard deviation of the blank population
MDA without Blank Population

3.29 ∗
𝑏
𝑇𝑠
+
𝑏
𝑇𝑏
𝐾+
3
𝐾𝑇𝑠
MDA =
Where:
b = background count rate in cpm
Tb = Count time of background in minutes
Relative Error Ratio (RER)/Normalized Absolute Difference (NAD)/Duplicate Error Ratio (DER)
RER, NAD, and DER are used for radiochemical analysis and are calculated by the following:
Where:
S = Sample Value
US = Sample Uncertainty (at 2 sigma)
R = Replicate Value
UR = Replicate Uncertainty (at 2 sigma)
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Executive Vice President: Paul Ellingson

_________________________________________

__________

Director of Quality: Jennifer Osborn

_________________________________________

__________

Laboratory Director: Reed Hendricks

_________________________________________

__________
QUALITY MANUAL

This Quality Manual meets the requirements of TNI-2016 and ISO 17025-2005.
This manual is confidential. All Employees have access to a controlled version
through Quality Manager. Printed copies are not considered controlled
documents.

9632 South 500 West
Sandy, UT 84070
[phone]
1384 West 130 South
Orem, UT 84058
[phone]
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Table of Contents
1. Introduction Page 3
2. Scope Page 3
3. Terms and Definitions Page 4
4. Management Requirements Page 10
4.1. Organization Page 10
4.2. Management Systems Page 16
4.3. Document Control Page 20
4.4. Review of Requests, Tenders, and Contracts Page 21
4.5. Subcontracting of Tests and Calibrations Page 23
4.6. Purchasing Services and Supplies Page 24
4.7. Service to the Customer Page 25
4.8. Complaints Page 26
4.9. Control of Nonconforming Testing and Calibration Work Page 26
4.10. Improvement Page 27
4.11. Corrective Action Page 28
4.12. Preventive Action Page 30
4.13. Control of Records Page 31
4.14. Internal Audits Page 33
4.15. Management Review Page 34
5. Technical Requirements Page 35
5.1. General Page 35
5.2. Personnel Page 35
5.3. Accommodation and Environmental Conditions Page 47
5.4. Environmental Methods and Method Validation Page 49
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5.5. Calibration Requirements Page 56
5.6. Measurement Traceability Page 62
5.7. Collection of Samples Page 68
5.8. Handling Samples and Test Items Page 68
5.9. Quality Assurance for Environmental Testing Page 72
5.10. Reporting of Results Page 76
6. References Page 79
7. Appendices Page 79

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1. Introduction
1.1 This Quality Manual contains the requirements used to demonstrate the quality management system,
technical competence, and valid results as defined by TNI-2016 and ISO-17025-2005
1.2 All personnel take an active role in establishing, implementing, and maintaining the quality
management program. Quality is integrated into every facet of the decision-making process in the
management of the laboratory.
1.3 Employees perform their duties in a consistently legal and ethical manner. A professionally high
level of ethical behavior is characterized by, but not limited to, dealing honestly and forthrightly
with all clients and coworkers, maintaining data integrity, the open and timely treatment of
inaccurate, invalid, or misreported analytical data, and abiding by all pertinent rules, regulations,
company policies, and standard operating procedures. Employees are encouraged to demonstrate
consistently ethical professional behavior by implementing programs constant with that purpose.
These programs include:
1.3.1 A thorough training program for new employees and continuing seminars throughout
employment which reflect the commitment to integrity and quality control and which present
specific ways to honor that commitment.
1.3.2 A comprehensive documentation program for all facets of laboratory operation which allows
for reconstruction of any quality process.
1.3.3 A program of continual evaluation, both internally and externally, with required levels of
quality acceptance.
1.3.4 A management monitoring system which routinely evaluates the overall performance of the
laboratory.
2. Scope
2.1. This document provides the basis for the following:
2.1.1. The recognition of technical competence for standardized methods, non-routine methods, and
laboratory-developed methods performed.
2.1.2. The inspection and product certification capabilities and/or services provided.
2.1.3. The total quality for administrative and technical systems.
2.1.4. Audits by accreditation bodies, regulatory authorities, and clients.
2.1.5. Meeting the requirements of TNI-2016 and ISO-17025-2005.
2.2. All Fields of Accreditation for the laboratory are listed online.
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3. Terms and Definitions
3.1. The definitions listed in this section may be taken directly from EL-V1M2-2016-Rev2.1 of the TNI-
2016 standard.
3.2. Acceptance Criteria – Specified limits placed on characteristics of an item, process, or service
defined in requirement documents.
3.3. Accreditation – The process by which an agency or organization evaluates and recognizes a
laboratory as meeting certain predetermined qualifications or standards.
3.4. Accuracy – The degree of agreement between an observed value and an accepted reference value. It
includes a combination of random error, or precision, and systematic error, or bias, components that
are due to sampling and analytical operations. It is an indication of data quality.
3.5. Analyst – The designated individual who performs the “hands-on” analytical methods and associated
techniques, and who is the one responsible for applying required laboratory practices and other
pertinent quality controls to meet the required level of quality.
3.6. Analyte – A substance, organism, physical parameter, property, or chemical constituent(s) for which
an environmental sample is analyzed.
3.7. Analytical Uncertainty – A subset of Measurement Uncertainty that includes all laboratory activities
performed as part of the analysis.
3.8. Assessment – The evaluation process used to measure or establish the performance, effectiveness,
and conformance of an organization and/or its systems to defined criteria.
3.9. Audit – A systematic and independent examination of facilities, equipment, personnel, training,
procedures, record keeping, data validation, data management, and reporting aspects of a system to
determine whether QA/QC and technical activities are being conducted as planned and whether
these activities will effectively achieve quality objectives.
3.10. Batch – Environmental samples that are prepared and/or analyzed together with the same process
and personnel, using the same lot(s) of reagents. A preparation batch is composed of one (1) to
twenty (20) environmental samples of the same quality system matr4ix, meeting the above-
mentioned criteria and with a maximum time between the start of process of the first and last sample
in the batch to be twenty-four (24) hours. An analytical batch is composed of prepared
environmental samples (extracts, digestates, or concentrates) which are analyzed together as a group.
An analytical batch can include prepared samples originating from various quality system matrices
and can exceed twenty (20) samples.
3.11. Blank - A sample that has not been exposed to the analyzed sample stream in order to monitor
contamination during sampling, transport, storage, or analysis. The blank is subjected to the usual
analytical and measurement process to establish a zero baseline or background value and is
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sometimes used to adjust or correct routine analytical results. A method blank is a sample of a
matrix similar to the batch of associated samples (when available) that is free from the analytes of
interest and is processed simultaneously with and under the same conditions as samples through all
steps of the analytical procedures, and in which no target analytes or interferences are present at
concentrations that impact the analytical results for sample analyses.
3.12. Calibration - A set of operations that establish, under specified conditions, the relationship between
values of quantities indicated by a measuring instrument or measuring system, or values represented
by a material measure or a reference material, and the corresponding values realized by standards.
3.12.1. In calibration of support equipment, the values realized by standards are established through
the use of reference standards that are traceable to the International System of Units (SI).
3.12.2. In calibration according to methods, the values realized by standards are typically established
through the use of Reference Materials that are either purchased by the laboratory with a
certificate of analysis or purity, or prepared by the laboratory using support equipment that
has been calibrated or verified to meet specifications.
3.13. Calibration Curve – The mathematical relationship between the known values, such as
concentrations, of a series of calibration standards and their instrument response.
3.14. Calibration Standard – A substance or reference material used for calibration.
3.15. Certified Reference Material (CRM) - Reference material, accompanied by a certificate, having a
value, measurement uncertainty, and stated metrological traceability chain to a national metrology
institute.
3.16. Chain of Custody Form – Record that documents the possession of the samples from the time of
collection to receipt in the laboratory. This record generally includes: the number and types of
containers; the mode of collection; the collector; time of collection; preservation; and requested
analyses.
3.17. Confirmation – Verification of the identity of a component through the use of an approach with a
different scientific principle from the original method. These may include, but are not limited to:
Second column confirmation, Alternate wavelength, Derivatization, Mass spectral interpretation,
Alternative detectors, or Additional cleanup procedures.
3.18. Data Integrity – The condition that exists when data are sound, correct, and complete, and accurately
reflect activities and requirements.
3.19. Data Reduction – The process of transforming the number of data items by arithmetic or statistical
calculation, standard curves, and concentration factors, and collating them into a more useful form.
3.20. Demonstration of Capability – A procedure to establish the ability of the analyst to perform analyses
with acceptable accuracy and precision.
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3.21. Field of Accreditation – Those matrix, technology/method, and analyte combinations for which the
accreditation body offers accreditation.
3.22. Finding – An assessment conclusion referenced to a laboratory accreditation standard and supported
by objective evidence that identifies a deviation from a laboratory accreditation standard
requirement.
3.23. Holding Times - The maximum time that can elapse between two (2) specified activities.
3.24. In-depth Data Monitoring – When used in the context of data integrity activities, a review and
evaluation of documentation related to all aspects of the data generation process that includes items
such as preparation, equipment, software, calculations, and quality controls. Such monitoring shall
determine if the laboratory uses appropriate data handling, data use and data reduction activities to
support the laboratory’s data integrity policies and procedures.
3.25. Internal Standard – A known amount of standard added to a test portion of a sample as a reference
for evaluating and controlling the precision and bias of the applied analytical method.
3.26. Laboratory Control Sample (however named, such as laboratory fortified blank, spiked blank, or QC
check sample) – A sample matrix, free from the analytes of interest, spiked with verified known
amounts of analytes or a material containing known and verified amounts of analytes and taken
through all sample preparation and analytical steps of the procedure unless otherwise noted in a
reference method. It is generally used to establish intra-laboratory or analyst specific precision and
bias or to assess the performance of all or a portion of the measurement system.
3.27. Limit(s) of Detection (LOD) – The minimum result, which can be reliably discriminated from a
blank with a predetermined confidence level. Also called Detection Limit.
3.28. Limit(s) of Quantitation (LOQ) – The minimum levels, concentrations, or quantities of a target
variable (e.g., target analyte) that can be reported with a specified degree of confidence.
3.29. Lot – A definite amount of material produced during a single manufacturing cycle, and intended to
have uniform character and quality.
3.30. Matrix – The substrate of a test sample.
3.31. Matrix Duplicate – A replicate matrix prepared in the laboratory and analyzed to obtain a measure of
precision.
3.32. Matrix Spike (spiked sample or fortified sample) - A sample prepared, taken through all sample
preparation and analytical steps of the procedure unless otherwise noted in a referenced method, by
adding a known amount of target analyte to a specified amount of sample for which an independent
test result of target analyte concentration is available. Matrix spikes are used, for example, to
determine the effect of the matrix on a method's recovery efficiency.
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3.33. Matrix Spike Duplicate (spiked sample or fortified sample duplicate) – A replicate matrix spike
prepared in the laboratory and analyzed to obtain a measure of the precision of the recovery for each
analyte.
3.34. Measurement System – A method, as implemented at a particular laboratory, and which includes the
equipment used to perform the test and the operator(s).
3.35. Method – A body of procedures and techniques for performing an activity (e.g., sampling, chemical
analysis, quantification), systematically presented in the order in which they are to be executed.
3.36. Method Detection Limit – The minimum measured concentration of a substance that can be reported
with 99% confidence that the measured concentration is distinguishable from method blank results.
3.37. National Institute of Standards and Technology (NIST) – A federal agency of the US Department of
Commerce’s Technology Administration that is designed as the United States national metrology
institute (NMI).
3.38. Physical Parameter – A measurement of a physical characteristic or property of a sample as
distinguished from the concentrations of chemical or biological components.
3.39. Precision – The degree to which a set of observations or measurements of the same property,
obtained under similar conditions, conform to themselves; a data quality indicator. Precision is
usually expressed as standard deviation, variance or range, in either absolute or relative terms.
3.40. Preservation – Any conditions under which a sample must be kept in order to maintain chemical
and/or biological integrity prior to analysis.
3.41. Procedure – A specified way to carry out an activity or process. Procedures can be documented or
not.
3.42. Proficiency Testing – A means of evaluating a laboratory’s performance under controlled conditions
relative to a given set of criteria through analysis of unknown samples provided by an external
source.
3.43. Proficiency Testing Program - The aggregate of providing rigorously controlled and standardized
environmental samples to a laboratory for analysis, reporting of results, statistical evaluation of the
results and the collective demographics and results summary of all participating laboratories.
3.44. Proficiency Testing Sample (PT) – A sample, the composition of which is unknown to the laboratory
and is provided to test whether the laboratory can produce analytical results within the specified
acceptance criteria.
3.45. Protocol – A detailed, written procedure for field and/or laboratory operation (e.g., sampling,
analysis) which must be strictly followed.
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3.46. Quality Assurance (QA) – An integrated system of management activities involving planning,
implementation, assessment, reporting, and quality improvement to ensure that a process, item, or
service is of the type and quality needed and expected by the client.
3.47. Quality Control (QC) – The overall system of technical activities that measures the attributes and
performance of a process, item, or service against defined standards to verify that they meet the
stated requirements established by the customer; operational techniques and activities that are used
to fulfill requirements for quality; also the system of activities and checks used to ensure that
measurement systems are maintained within prescribed limits, providing protection against “out of
control” conditions and ensuring that the results are of acceptable quality.
3.48. Quality Control Sample – A sample used to assess the performance of all or a portion of the
measurement system. One of any number of samples, such as Certified Reference Materials, a
quality system matrix fortified by spiking, or actual samples fortified by spiking, intended to
demonstrate that a measurement system or activity is in control.
3.49. Quality Manual – A document stating the management policies, objectives, principles,
organizational structure and authority, responsibilities, accountability, and implementation of an
agency, organization, or laboratory, to ensure the quality of its product and the utility of its product
to its users.
3.50. Quality System – A structured and documented management system describing the policies,
objectives, principles, organizational authority, responsibilities, accountability, and implementation
plan of an organization for ensuring quality in its work processes, products (items), and services. The
quality system provides the framework for planning, implementing, and assessing work performed
by the organization and for carrying out required QA and QC activities.
3.51. Quality System Matrix - These matrix definitions are to be used for purposes of batch and QC
requirements.
3.51.1. Aqueous – Any aqueous sample excluded from the definition of Drinking Water or
Saline/Estuarine. Includes surface water, ground water effluents, and TCLP or other
extracts.
3.51.2. Chemical Waste – A product or by-product of an industrial process that results in a matrix
not previously defined.
3.51.3. Drinking Water – Any aqueous sample that has been designated a potable or potential
potable water source.
3.51.4. Non-Aqueous Liquid – Any organic liquid with <15% settleable solids.
3.51.5. Saline/Estuarine – Any aqueous sample from an ocean or estuary, or other salt water source
such as the Great Salt Lake.
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3.51.6. Solids - Includes soils, sediments, sludges, and other matrices with >15% settleable solids.
3.52. Raw Data – The documentation generated during sampling and analysis. This documentation
includes, but is not limited to, field notes, electronic data, magnetic tapes, un-tabulated sample
results, QC sample results, print outs of chromatograms, instrument outputs, and handwritten
records.
3.53. Reference Material – Material or substance, one or more of whose property values are sufficiently
homogeneous and well established to be used for the calibration of an apparatus, the assessment of a
measurement method, or for assigning values to materials.
3.54. Reference Method – A reference method is a published method issued by an organization generally
recognized as competent to do so. (When the ISO language refers to a “standard method”, that term
is equivalent to “reference method”). When a laboratory is required to analyze an analyte by a
specified method due to a regulatory requirement, the analyte/method combination is recognized as a
reference method. If there is not a regulatory requirement for the analyte/method combination, the
analyte/method combination is recognized as a reference method if it can be analyzed by another
reference method of the same matrix and technology.
3.55. Reference Standard - Standard used for the calibration of working measurement standards in a given
organization or at a given location.
3.56. Sampling – Activity related to obtaining a representative sample of the object of conformity
assessment, according to a procedure.
3.57. Selectivity – The ability to analyze, distinguish, and determine a specific analyte from another
component that may be a potential interferent or that may behave similarly to the target analyte
within the measurement system.
3.58. Sensitivity – The capability of a method or instrument to discriminate between measurement
responses representing different levels (e.g., concentrations) of a variable of interest.
3.59. Standard – The document describing the elements of laboratory accreditation that has been
developed and established within the consensus principles of standard setting and meets the approval
requirements of standard adoption organizations procedures and policies.
3.60. Standard Operating Procedures (SOPs) – A written document that details the method for an
operation, analysis, or action, with thoroughly prescribed techniques and steps. SOPs are officially
approved as the methods for performing certain routine or repetitive tasks.
3.61. Technology – A specific arrangement of analytical instruments, detection systems, and/or
preparation techniques.
3.62. Traceability – The ability to trace the history, application, or location of an entity by means of
recorded identifications. In a calibration sense, traceability relates measuring equipment to national
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or international standards, primary standards, basic physical constants or properties, or reference
materials. In a data collection sense, it relates calculations and data generated throughout the project
back to the requirements for the quality of the project.
3.63. Verification - Confirmation by examination and objective evidence that specified requirements have
been met. In connection with the management of measuring equipment, verification provides a
means for checking that the deviations between values indicated by a measuring instrument and
corresponding known values of a measured quantity are consistently smaller than the maximum
allowable error defined in a standard, regulation or specification peculiar to the management of the
measuring equipment..
3.64. See Appendix 1 for a list of acronyms used by the laboratory.
4. Management Requirements
4.1 Organization
4.1.1 The legally responsible entity is Chemtech-Ford, Inc. located at 9632 South 500 West in
Sandy Utah. The phone number is [phone] or [phone].
4.1.2 Chemtech-Ford, Inc. meets the requirements of the TNI-2016 standard and satisfies the needs
of the customer by dividing the laboratory into the following groups:
President/CEO/Vice President
Laboratory Director
QA/QC Department
Customer Service Department
Receiving/Shipping Department
Organics Laboratory
Inorganics Laboratory
Microbiology Laboratory
Metals Laboratory
4.1.3 The management system covers activities in all of the laboratories facilities. The fields of
activities include environmental sample testing, medical device testing, nutraceutical product
testing, and specialty testing. The laboratories scope of tests is listed in the current price list.
4.1.4 Chemtech-Ford, Inc. is not part of an organization performing activities other than testing.
4.1.5 Laboratory Organization
4.1.5.1 Management and Technical Personnel: The laboratory managerial and technical
personnel, irrespective of other responsibilities, have the necessary authority and
resources to meet the mandates assigned to their areas. See also section 5.2.
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4.1.5.1.1 Departures from the organizational management policies in this manual
can only be approved by a Vice President.
4.1.5.1.2 Departures from quality management system procedures can only be
approved by a Vice President or the Quality Manager.
4.1.5.1.3 Departures from test methods or technical SOPs can only be approved
by the Quality Manager and/or the Laboratory Director.
4.1.5.2 Conflict of Interest: Management and personnel are to be free from undue internal
and external commercial, financial, and other pressures that may adversely affect
the quality of their work. The integrity of test results is the responsibility of all
personnel. Management ensures that employees are never instructed or forced to
alter or falsify data. Chemtech-Ford, Inc. performs annual data integrity training.
A review on undue pressure policy is part of this training.
4.1.5.2.1 The following list provides some guidelines on how employees avoid
conflict of interest situations.
4.1.5.2.1.1 Employees shall not falsify records, prepare fraudulent
reports, or make false claims.
4.1.5.2.1.2 Employees shall not seek or use privileged or confidential
company information or data from any customer for any
purpose beyond the scope of employment.
4.1.5.2.1.3 Employees shall not conduct non-laboratory business on
laboratory time or use company facilities or equipment to
conduct outside interest in business, unless prior approval
has been obtained.
4.1.5.2.1.4 Employees shall not solicit business on their own behalf,
rather than the laboratory, from a customer.
4.1.5.2.1.5 Employees shall not be employed by or affiliated with
organizations whose products or services compete with
laboratory products or services.
4.1.5.2.1.6 Employees shall not have employment that negatively
affects or interferes with their performance of laboratory
duties.
4.1.5.2.1.7 Employees shall not compete with the laboratory in the
purchase, sale, or leasing of property or goods.
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4.1.5.2.1.8 Employees shall not allow association, family, or friends to
influence business decisions to their benefit. Decisions
must be made on a strictly business bases, always in the
best interest of the laboratory.
4.1.5.2.1.9 Employees shall not make any decision that provides gains
or benefits to the employee and/or others.
4.1.5.2.1.10 Employees shall not have personal financial dealings with
an individual or company that does business with the
laboratory which might influence decisions made on the
laboratories’ behalf.
4.1.5.2.2 Firm adherence to this code of values forms the foundation of
credibility. Personnel involved in dishonest activities are subject to a
range of disciplinary action, including dismissal.
4.1.5.3 Customer Confidentiality. It is the policy of the laboratory to protect the
confidential information and proprietary rights of our customers including the
electronic storage and transmission of results.
4.1.5.3.1 All employees sign a Confidentiality Agreement. The signed agreement
is retained in each employee’s Human Resources file.
4.1.5.3.2 Test results are only released to the customer. Release to someone other
than the customer requires the express permission of the customer,
except when the situation contravenes State or Federal Legislation and
the results must be provided to the appropriate agency. The release of
test results to anyone other than the customer requires the permission of
management. Laboratory reports are reviewed for accuracy prior to
release.
4.1.5.3.3 Chemtech-Ford, Inc. is required by law to release information if
subpoenaed. Only information specifically stated on the subpoena is
released.
4.1.5.4 Operational Integrity. The laboratory will avoid involvement in any activities that
would diminish confidence in its competence, impartiality, judgement, or
operational integrity.
4.1.5.4.1 To ensure confidence in laboratory operations, a formal quality
assurance program is implemented. Technical competence is ensured
through commercial performance testing studies and data formatted in
DOC reports.
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4.1.5.4.2 Impartiality is assessed through audits and approvals.
4.1.5.4.3 Judgment is assured through the hiring of qualified personnel and by
continuously refining, upgrading, and improving his or her skills.
4.1.5.4.4 Operational integrity is reviewed by management on a regular basis at
management review meetings to ensure continued suitability and
effectiveness of laboratory policies and procedures.
4.1.5.4.5 Any problems are acted on immediately through corrective action
procedures.
4.1.5.5 Organizational Structure. The organization and management structure of the
laboratory and the relationships between management, technical operations, support
services, and the quality management system is defined through the aid of and
organizational chart.
4.1.5.5.1 The most current organizational structure is contained within Quality
Manager. The organizational structure is reviewed at regular intervals,
at least annually.
4.1.5.6 Responsibility and Authority. The responsibility, authority, and interrelationships
of all personnel who manage, perform, or verify work affecting the quality of the
tests and/or calibrations is defined in section 5.2.
4.1.5.7 Laboratory Supervision. Adequate supervision is provided in each area of the
laboratory for all testing and calibration personnel, including trainees, by persons
familiar with methods and procedures, purpose of each test and/or calibration, and
with the assessment of the test or calibration results.
4.1.5.7.1 Adequate supervision is ensured through designated supervisors as well
as through documentation such as this Quality Manual, test methods,
and SOPs. Initial and ongoing training for regular personnel is required.
The successful completion of analysis in the commercial PT program
and/or DOC studies are evidence of successful and continued training.
4.1.5.8 Technical Management. A technical manager is assigned to each major work area
of the laboratory. They have overall responsibility for the technical operations and
the provision of resources needed to ensure the required quality of laboratory
operations.
4.1.5.8.1 While the technical manager may at times delegate duties to other
personnel, the technical manager is responsible for the work produces in
the area of the laboratory and is accountable for any non-conforming
activities.
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4.1.5.9 Quality Manager. The Quality Manager is appointed by the highest level of
management. The Quality Manager, irrespective of other duties and
responsibilities, has defined responsibility and authority for ensuring the
management system related to quality is implemented and followed. The Quality
Manager has direct access to the highest level of management where decisions are
taken on laboratory policy or resources.
4.1.5.9.1 The Quality Manager is authorized by senior management and the
President/Vice President to administer all activities relating to the
quality system. A formal announcement to the laboratory and
appropriate certification and/or regulatory authorities will be made if a
change is made to the person filling this position.
4.1.5.10 Managerial Substitutions. Deputies for key personnel are appointed to fulfill the
key personnel’s duties in their absence.
4.1.5.10.1 In the absence of the Lab Director, the Quality Manager or Deputy Lab
Director will assume his/her responsibilities.
4.1.5.10.2 In the absence of the Quality Manager, the Lab Director will assume
his/her responsibilities.
4.1.5.10.3 In the absence of the Laboratory Supervisor, the Lab Director, Deputy
Lab Director, and/or Quality Manager will assume his/her
responsibilities.
4.1.5.10.4 Management is responsible for ensuring that current and/or increased
workload requirements are met. This includes making adjustments as a
result of employee absence. Only fully trained employees are utilized to
fulfill the duties of personnel who are absent. Evidence of a DOC for
each specific analysis must be recorded prior to allowing the employee
to perform any testing in the laboratory. If sufficient human resources
are not available, management will identify the best possible solution to
meet operational requirements.
4.1.5.11 Awareness. Management ensures that its personnel are aware of the relevance and
importance of their activities and how they contribute to the achievement of the
objectives of the management system.
4.1.5.11.1 Management review the details of each employee’s duties with the
appropriate employee. Employees are trained on the principals of the
Quality Policy Statement and how it relates to their activities to achieve
the objectives of the management system.
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4.1.6 Communication Processes. Top management ensures that appropriate communication
processes are established within the laboratory and that communication takes place regarding
the effectiveness of the management system.
4.1.6.1 Management meetings are held regularly. Assignments and important
communications are made in this meeting. These meetings are documented and
follow-up activities are recorded.
4.1.7 The quality manager or designee has the following functions.
4.1.7.1 Serves as the focal point for QA/QC and is responsible for the review of QC data.
4.1.7.2 Has functions which are independent from laboratory operations.
4.1.7.3 Are able to evaluate data objectively and perform assessments without outside
influence.
4.1.7.4 Has documented training and/or experience in QA/QC procedures and the
laboratories quality system. All training is documented in Quality Manager.
4.1.7.5 Has a general knowledge of the analytical methods for which data review is
performed.
4.1.7.6 Conducts internal audits as per section 4.14.
4.1.7.7 Notifies laboratory management of deficiencies in the quality system.
4.1.7.8 Monitors corrective actions. Open corrective actions are reviewed on a regular
basis when follow-up is necessary.
4.1.7.9 Ensures the Quality Manual is current.
4.1.8 The technical manager or designee has the following functions.
4.1.8.1 Must be a member of the staff of the laboratory who exercises actual day-to-day
supervision of laboratory operations for the appropriate fields of accreditation and
reporting of results.
4.1.8.2 Must be experienced in the fields of accreditation for which the laboratory is
accredited.
4.1.8.3 Monitor standards of performance and validity of the analyses performed and
generated in the laboratory to assure reliable data.
4.1.8.4 If absent for a period of time exceeding fifteen consecutive calendar days, another
member of staff meeting the qualifications of technical manager will perform this
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function. If absent for a time exceeding thirty-five consecutive calendar days, the
primary accreditation body will be notified in writing.
4.2 Management Systems
4.2.1 Policies and Procedures: The Quality Management System is established, implemented, and
maintained by management. It is applicable to all fields of testing and activities in which the
laboratory is involved and undertakes. All policies, systems, programs, procedures, and
instructions are documented to the extent necessary to enable the laboratory to assure the
quality of generated results. These documents are communicated to, understood by,
available to, and implemented by the appropriate personnel.
4.2.1.1 The purpose of the Quality Management System is to ensure that all services and
products satisfy the customer’s requirements and have been designed, tested, and
delivered under controlled conditions.
4.2.1.2 The effectiveness of the Quality Management System is assessed in several ways.
4.2.1.2.1 By a program of planned internal audits, covering all aspects of the
operation of the quality management system.
4.2.1.2.2 By regular management reviews of the suitability and effectiveness of
the quality management system.
4.2.1.2.3 By analysis of potential and actual problems shown by customer
complaints and supplier and subcontractor assessments.
4.2.2 Quality Policy Statement: The policies and objectives for laboratory operations are
documented in this Quality Manual. The overall objectives are set out in the Quality Policy
Statement and reviewed my management during management review. The Quality Policy
Statement is issued under the authority of the Senior Management on the effective date.
4.2.2.1 Quality Policy Statement Effective February 15, 2016. The laboratory will ensure
accurate and timely analytical services and continuously meet or exceed the stated
or implied expectations of our customers through day-to-day interactions.
4.2.2.1.1 Management commitment to good professional practice and quality of
services provided to the customer. Tests and calibrations are always
carried out in accordance with stated standardized methods and
customer’s requirements. Requests to perform tests that may jeopardize
an objective result or have a low validity are rejected, or the laboratory’s
concerns are noted in the certificate of analysis.
4.2.2.1.2 Standards of Service include customer satisfaction, accuracy, timeliness,
and compliance with applicable standards and procedures. Excellence in
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the workplace is promoted by providing all employees with the
knowledge, training, and tools necessary to allow for the completion of
accurate and timely work.
4.2.2.1.3 Purpose of management system related to quality: to manage our
business by meeting the needs of our customers and the requirements of
the applicable standards and procedures.
4.2.2.1.4 Personnel: familiarize them with quality documentation and implement
the policies and procedures in their work.
4.2.2.2 Management is committed to complying with the applicable standards and
regulations and to continually improve the effectiveness of the management system.
The objective of this Quality Policy is to document the compliant policies and
associated procedures that are integrated into our daily activities. Continual
improvements are established, implemented, and locked into the management
system.
4.2.2.3 Additional objectives include: establish the level of the laboratory’s performance;
make test method changes to improve performance; participate in proficiency
testing or quality evaluation programs with peer laboratories; ensure that all
personnel are trained to a level of familiarity with the quality management system
appropriate to the individual’s degree of responsibility; improve and validate
laboratory methodologies by participation in method validation collaborative tests;
establish and report on quality savings.
4.2.3 Commitment to the Management System: Top management is committed to the
development and implementation of the management system and continually improves its
effectiveness. The results of management system are regularly reviewed during management
review and continual improvements are made as in section 4.10.
4.2.4 Communication of Requirements: Top management communicates to the organization the
importance of meeting customer requirements as well as statutory and regulatory
requirements. The underlying message in all oral and written management communications
involves meeting the aforementioned requirements. Meeting customer requirements ensures
that ongoing business relationships secure the contracts that keep everyone employed.
Meeting statutory and regulatory requirements ensures that laboratory operations will not be
disrupted and the organization can continue to meet customer needs.
4.2.5 Structure of Documentation: The quality management system is structured in three tiers of
documentation: 1) Quality Manual, 2) Standard Operating Procedures and Test Methods, 3)
Records.
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4.2.6 Integrity of Management System: Top management ensures that the integrity of the
management system is maintained when changes to the management system are planned and
implemented. For most customers, this Quality Manual and the associated documents for a
general Quality Plan. If necessary, specific Quality Plans will be prepared on a “per-
customer” basis. These Quality Plans will modify the general requirements stated in the
Manual and associated documents.
4.2.7 Documented Data Integrity System: Data integrity is defined as the consistent adherence to
required protocol and/or methodology from the time a sample is taken until the data is
archived and the sample discarded. The laboratory has the following 4 elements of the data
integrity system; Data Integrity Training, Signed Data Integrity Documentation, Periodic In-
Depth Monitoring, and Data Integrity Procedure Documentation.
4.2.7.1 Data Integrity Training – A new hire will be trained with respect to the overall
business practices and policies in place. An approved copy of each SOP for which
the analyst will be responsible will be provided. Before the new hire may perform
analyses, he/she must demonstrate a competency with the analysis. Data Integrity
training is provided for all employees on an annual basis.
4.2.7.1.1 Topics discussed in the annual training meeting may include the
laboratories mission and relationship to the critical need for honesty and
full disclosure in all analytical reporting, how and when to report data
integrity issues, record keeping. Discussions include all data integrity
procedures, the documentation required for training, in-depth data
monitoring, and specific examples of breaches of ethical behavior.
4.2.7.2 Signed Data Integrity Documentation – All employees sign that they have read the
SOP for data integrity and have attended the data integrity training meeting.
4.2.7.3 Periodic In-Depth Monitoring – Evaluation by company management is used to
insure that data quality meets the qualifications required for reporting. All data is
entered into the LIMS software where it is evaluated for standard parameters built
into the software. The LIMS system allows only supervisors and above to make
changes to existing data. The system keeps a log of changes made to data, the date
amended, the change made, and the person making the change. Data is periodically
inspected by the Quality Manager.
4.2.7.4 Data Integrity Procedure Documentation – Documentation for the data integrity
system is stored electronically in the Quality Manager database.
4.2.7.5 Any infractions of the data integrity procedures shall result in a detailed
investigation that could lead to very serious consequences including immediate
termination or civil/criminal prosecution.
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4.2.7.6 The Quality Manager periodically inspects the performance of the Quality System
with respect to completeness of training files, completeness of DOCs, chemical and
instrument logs, and overall historical QA data.
4.2.7.7 The laboratory has a procedure for confidential reporting of data integrity issues.
The primary element of this procedure is to assure confidentiality and a receptive
environment in which all employees may privately discuss ethical issues or report
items of ethical concern. In instances of ethical concern, laboratory management is
to be informed of the need for any further detailed investigation.
4.2.7.7.1 An employee may discuss with any member of management areas of
concern. Management will conduct a confidential investigation. This
investigation may include personnel reviews, data audits, training
evaluations, data package review, internal method audits, and
surveillance to determine inappropriate practices.
4.2.7.7.2 Any employee who participates in unethical practices is subject to
disciplinary action. Any employee who is aware of an unethical
practice and does not bring it to the attention of management, is
subject to disciplinary action.
4.2.8 Quality Manual: The following are referenced or contained within this Quality Manual.
4.2.8.1 Maintenance, calibration, and verification procedures.
4.2.8.2 Major equipment and reference measurement standards.
4.2.8.3 Verification practices including PT programs, use of reference materials, and
internal QC schemes.
4.2.8.4 Procedure for reporting analytical results.
4.2.8.5 The organization and management structure of the laboratory.
4.2.8.6 Procedures to ensure that all records are retained as well as procedures for control
and maintenance of documentation.
4.2.8.7 Job description of key staff and reference to the job descriptions of other laboratory
staff.
4.2.8.8 Procedures for achieving traceability of measurements.
4.2.8.9 A list of all methods under which the laboratory performs its accredited testing.
4.2.8.10 Procedure for ensuring the laboratory reviews all new work to ensure it has the
appropriate facilities and resources.
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4.2.8.11 Procedure for handling samples.
4.2.8.12 Procedure to be followed for feedback and corrective action when testing
discrepancies are detected or departures from documented policies and procedures
occur.
4.2.8.13 Policy for permitting departures from documented policies and procedures.
4.2.8.14 Procedures for dealing with complaints.
4.2.8.15 Procedures for protecting confidentiality and proprietary rights (4.1.5.3).
4.2.8.16 Procedures for audits and data review.
4.2.8.17 Procedures for establishing personnel are adequately experienced in the duties they
are expected to carry out and are receiving any needed training.
4.2.8.18 Policy addressing the use of unique electronic signatures.
4.2.9 Laboratory SOPs: An SOP is maintained for all accredited methods. All SOPs have an
effective date and a revision number. SOPs may be accessed by all employees through the
Quality Manager software. Obsolete versions are archived.
4.3 Document Control
4.3.1 Policies and Procedures.
4.3.1.1 Document control ensures that authorized editions of appropriate documents are
available at all locations where operations essential to the effective functioning of
the laboratory are performed; documents are periodically reviewed and where
necessary revised to ensure continuing suitability and compliance with applicable
requirements; invalid or obsolete documents are promptly removed from all points
of issue or use to assure against unintended use; obsolete documents retained for
either legal or knowledge preservation are suitably marked.
4.3.1.2 Quality Manager software maintains a master list of all controlled documents,
including SOPs, source methods, and user manuals.
4.3.1.3 The control of data related to testing and calibration is covered in 5.4.7. The
control of records is covered in section 4.13.
4.3.2 Document Approval and Issue.
4.3.2.1 All documents issued to personnel in the laboratory as part of the quality
management system are reviewed and approved for use by authorized personnel
prior to issue. A master list can be obtained by viewing the list located in the
Quality Manager software. The categories are divided for easy access.
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4.3.2.2 All employees have access to the current version of the SOP through Quality
Manager software. These documents are periodically reviewed and revised when
necessary. Documentation of the review is stored in Quality Manager.
4.3.2.3 Obsolete documents are retained for either legal or knowledge preservation
purposes. They removed from Quality Manager and placed in the Archive drive on
the server.
4.3.2.4 All SOPs have a date of issue, revision number, page numbering with the total
number of pages, and the issuing authority (i.e. reviewer approval).
4.3.3 Document Changes
4.3.3.1 Changes to documents are reviewed and approved by the same function that
performed the original review.
4.3.3.2 Developments in policies and procedures require documents to be changed from
time to time. Changes to documents receive the same level of review and approval
as the originals.
4.4 Review of Requests, Tenders, and Contracts
4.4.1 Policies and Procedures.
4.4.1.1 Prior to the commencement of any services that fall within the scope of this Quality
System, Chemtech-Ford, Inc. will ensure that the scope of work is clearly defined
and that the objectives of the project can be met. In some cases, the request are
formalized through a statement of work and signed contract. Other cases require
less formalized contracts. In all instances Chemtech-Ford, Inc. formalizes a
contract between the laboratory and the client. The lab ensures that the customer
requirements including the methods to be used are adequately defined, documented,
and understood; the laboratory has the capability and resources to meet the
requirements; the appropriate test method is selected and capable of meeting the
customer’s requirements. When practicable, any differences between the request or
tender and the contract are resolved before work commences. Each contract must
be acceptable by both the laboratory and the customer.
4.4.1.2 The review of capability establishes that the laboratory possesses the necessary
physical, personnel, and information resources, and that the laboratory’s personnel
have the skills and expertise necessary for the performance of the tests in question.
The review may also encompass results of earlier participation in inter-laboratory
comparisons or proficiency testing and/or the running of trial test using samples or
items of known value in order to determine uncertainties of measurement, limits of
detection, and confidence limits.
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4.4.1.3 Some contracts are formalized through a bidding process, RFP etc. Some contracts
are less formal. When a formal process initiates the work, the specifications of the
project are agreed upon and programed into the LIMS. When appropriate, contracts
are signed by necessary parties.
4.4.1.4 All work orders at Chemtech-Ford, Inc. are considered contracts between the lab
and the customer. After logging the sample(s) into the LIMS and after a login
review is performed by the lab, a login summary of requested analyses is submitted
to the customer for their review. The customer is informed of tests to be performed
including test method, subcontracted work, conditions of samples upon receipt and
any other anomaly that might have an adverse effect on the results of the analyses.
The customer is requested to review the work order for accuracy and note any
discrepancies to the lab in a timely manner. If the customer does not reply in a
timely manner, Chemtech-Ford, Inc. proceeds with the work. For some analyses,
the lab is required to start work immediately (e.g. short holding times or rush
analyses). The customer has the ability to stop this work as needed.
4.4.1.5 The contract review ensures that each customer’s requirements are adequately
defined and documented in a timely manner. This should ensure that any order,
once accepted, can be completed without delay, and that the customer’s
requirements including delivery date, technical specification can be met.
4.4.2 Records of review.
4.4.2.1 Records of request, tender and contract review, including significant changes, are
maintained. Records of pertinent discussions with a customer relating to the
customer’s requirements or the work during the period of execution of the contract
are also maintained.
4.4.2.2 Records of request is made by the client via chain of custody. Alternative requests
may also be made through other mechanisms (e.g. email). In the event that an
alternative mechanism besides the chain of custody is used for a request, such
documentation is retained. After samples have been entered into the LIMS and
reviewed for correctness, a summary of the requested work is sent to the client via
email to verify the accuracy of their request compared to Chemtech-Ford, Inc.
interpretation of the request. Chemtech-Ford, Inc. assumes that the request is
accurate unless the client informs us otherwise. If there is a discrepancy, the
change is noted and documented in the LIMS or chain of custody.
4.4.2.3 Other work may demand more complex and formalized contract review. These
contracts are maintained by Chemtech-Ford, Inc. and the client. Formal contracts
should be stored in the project in LIMS. The LIMS project can be customized for
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most of the project requirements such as pricing, analyte lists, reporting limits, QC
limits, report format, report recipients, etc.
4.4.2.4 When a formal contract is entered into between the lab and the client, the
appropriate lab member of management must sign the contract. The person
responsible for managing the project ensures that all of the aspects of the project
can be met. That person coordinates the project plan and execution of the project
with the appropriate laboratory staff. They also communicate any problems
meeting the client objectives to the client and will advise the lab how to proceed.
4.4.3 Review of subcontracted work.
4.4.3.1 Request, tender, and contract review also includes work that is subcontracted by the
laboratory. Subcontractor laboratories are reviewed as described in section 4.5.
Performance based methods developed by Chemtech-Ford, Inc. are not
subcontracted.
4.4.4 Notification of customer.
4.4.4.1 Customers are informed of deviations from the contract. This is typically
communicated to the customer prior to performing the deviation.
4.4.5 Contract amendment.
4.4.5.1 If a contract needs to be amended after the work has commenced, the same contract
review process is repeated and any amendments are communicated to all affected
personnel.
4.5 Subcontracting of Tests and Calibrations
4.5.1 Subcontractor competence.
4.5.1.1 Performance based methods developed by Chemtech-Ford, Inc. are not
subcontracted unless directed by the client. Work that must be subcontracted is
done so to a technically competent laboratory due to unforeseen circumstances,
workload, project specifications/requirements, or contracts requiring some extra
technical expertise.
4.5.1.2 The approved subcontract laboratories are maintained in Quality Manager.
4.5.2 Customer approval.
4.5.2.1 Customers are advised of work, or any portion thereof, that is being subcontracted
to another laboratory and their approval is obtained, preferably in writing.
Customers are advised of subcontracted work through the contracting process.
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4.5.3 Assurance of subcontractor competence.
4.5.3.1 If the laboratory selects the subcontracted lab, then the laboratory is responsible to
the customer for the subcontractor’s work. Technical competence of subcontractor
laboratories is demonstrated through various records including accreditation records
from the laboratories Accreditation Body. There may be circumstances where the
customer specifies which subcontractor is to be used. In such cases we may not be
able to demonstrate the competence of the subcontractor and therefore are not
responsible for the results.
4.5.3.2 The records of subcontractor competence can include, but is not limited to,
accreditation certificates or documentation, registration certificates, check sample
results, audit results, approval by the Quality Manager, or approval by the client.
4.5.4 Subcontractor register.
4.5.4.1 A register of all subcontractors performing tests and calibrations is maintained in
Quality Manager or within the project records. The approved register of
subcontractors is maintained by the applicable accreditation body or in the project
records.
4.5.5 Subcontractor accreditation.
4.5.5.1 When the laboratory subcontracts work, this work is placed with a laboratory which
holds TNI accreditation by the state of Utah for the tests to be performed or with a
laboratory that meets applicable statutory and regulatory requirements for
performing the tests and submitting the results of tests performed. The laboratory
performing the subcontracted work is noted on the final report. A copy of the
subcontractor’s report is available to the client upon request.

4.6 Purchasing Services and Supplies
4.6.1 Policies and procedures.
4.6.1.1 Services and supplies are purchased from an approved vendor. Requests for Purchase
of test materials and reagents are forwarded to the Purchasing Section, where they are
reviewed to ensure that the latest requirements are correct. The Purchasing Section may
then use the Purchase Order Form to place and plan orders as needed. Materials may be
subjected to incoming inspection procedures to determine if they meet specifications. If a
discrepancy is found that could affect the quality of laboratory output, the material is
replaced and a disposition record is kept. If the material is accepted, the material is logged
into the LIMS. Reagents and laboratory consumables are stored according to the
manufacturer recommendations.
4.6.2 Specifications.
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4.6.2.1 Only services and supplies of the required quality are used. These quality
requirements are detailed in laboratory SOPs under the “Equipment and Supplies ”
and “Reagents and Standards” sections and will identify the appropriate minimum
specifications when necessary. When the quality of media, reagents, chemicals,
solutions or solvents are checked against standards as part of the test method they
are used in, they are not checked prior to placing them in storage, other than to
validate the identity, shelf-life, or certification.
4.6.3 Purchasing documents.
4.6.3.1 Packing slips are checked against package content labels and matched with the
Purchase Order if accepted. Once accepted, the packing slip is dated and initialed as
evidence of compliance. Certificates of analysis (COA) are scanned and maintained
on file in the LIMS.
4.6.4 Approved Suppliers.
4.6.4.1 Suppliers of critical services are evaluated and approved before use. An approved
supplier list is maintained in Quality Manager. Supplier evaluation is conducted to
qualify suppliers of critical services prior to use. The criteria for evaluation may
include, but is not limited to, references, accreditation, or formal recognition.
Records of the approval are maintained in Quality Manager.
4.6.4.1.1 A supplier is qualified for the purchase of goods and services if they
hold current certification for ISO-17025, ISO-9001, or TNI.
4.7 Service to the Customer
4.7.1 Service
4.7.1.1 Customer requests are clarified for the customers or their representatives.
Furthermore, the customer or their representative will be afforded the right to
monitor the performance of the laboratory in relation to the work performed,
provided that the laboratory ensures confidentiality to other customers.
4.7.1.2 Service to the customer includes affording the customer or the customer’s
representative reasonable access to relevant areas of the laboratory for the
witnessing of work performed for the customer; it is understood that such access
should not conflict with rules of confidentiality of work for other customers or with
safety.
4.7.1.3 The laboratory maintains open contacts with its customers. The customer values
advice and guidance in technical matters, and opinions and interpretations based on
results. Contact with the customer, especially in large assignments, should be
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maintained throughout the work. The laboratory should inform the customer of any
delays or major deviations in the performance of the tests.
4.7.2 Feedback
4.7.2.1 The laboratory seeks feedback form the customer. Positive and negative feedback
are obtained passively through ongoing communications with the customer. The
feedback is used to improve the quality management system, testing activities, and
customer service.
4.7.2.2 Customer feedback is discussed during management meetings. When feedback
requires a corrective action, this is documented and assigned to the appropriate
team member for review.
4.8 Complaints
4.8.1 Employees receiving complaints are responsible for recording the details of the customer
complaint, do what they can to resolve the immediate problem or assure the customer that
their complaint will receive immediate attention, inform the customer that the laboratory will
contact them by a certain time or date, and pass the details of the complaint on to their
supervisor and advising them if the nature of the complaint is serious or might lead to legal
action. The nature of the complaint is circulated to all interested personnel within the
laboratory.
4.8.2 Managers/supervisors analyze the nature of the complaint (contacting the customer for
further information if necessary), initiate action to resolve the complaint, contact the
customer to determine whether the solution is sufficient, implement long-term solutions to
prevent the recurrence of this type of complaint, and monitor the effectiveness of the long-
term solution. Records are kept of the action taken, implementation of long-term solutions,
and monitoring of the effectiveness of the long-term solutions.
4.8.3 The Quality Manager follows up with all appropriate personnel to assure that the corrective
action has been implemented and demonstrated.
4.9 Control of Nonconforming Testing and Calibration Work
4.9.1 Procedures to control nonconforming work.
4.9.1.1 Any employee can halt work when nonconformities are identified. Technicians that
are fully trained in trouble-shooting equipment problems are authorized to resume
work that has been corrected before incorrect results have been reported to the
customers.
4.9.1.2 Identification of nonconforming work or problems with the quality management
system or with testing activities can occur at various locations within the quality
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management system and technical operations. Identification may be the result of
customer complaints, quality control, instrument calibration, checking of
consumable materials, staff observations or supervision, test report checking,
management reviews, or internal/external audits.
4.9.1.3 The laboratory area supervisor is responsible for authorizing the resumption of
work after effective corrective action has been taken to prevent the release of
unacceptable test results in the future. This requires the use of the corrective action
procedure (section 4.11) to find the root cause of the nonconformance and eliminate
future occurrences.
4.9.1.4 This procedure ensures that responsibilities and authorities for the management of
nonconforming work are designated and actions are defined and taken into
consideration when nonconforming work is identified; an evaluation of the
significance of nonconforming work is made; correction is taken immediately,
together with any decision about the acceptability of the nonconforming work;
when necessary, the customer is notified and the work is recalled; the responsibility
for authorizing the resumption of work is defined.
4.9.2 Root cause analysis.
4.9.2.1 Where evaluation indicates that nonconforming work could recur or that there is
doubt about the compliance of the laboratory’s operations with its own policies and
procedures, the corrective action procedures given in 4.11 are followed to identify
the root cause(s) of the problem and to eliminate this (these) cause(s). All notes,
discoveries, and actions taken by participating personnel are to be reflected on the
corrective action form. The Quality Manager directs this process and retains all
documentation within the appropriate files for future reference.
4.9.2.2 Nonconformance’s which warrant a corrective action investigation include failure
to comply with test method including all applicable procedures necessary to ensure
the integrity and representative nature of the sample; presentation of uncertain
knowledge as to compliance with test methods including all applicable procedures
necessary to ensure the integrity and representative nature of the sample; failure or
suspected failure in method performance as demonstrated by results provided by
quality control samples; lack of relevant evidence provided by quality audit,
proficiency testing, or customer feedback; lack of relevant evidence provided by
data validation; neglect to check the inherent property of the sample that
compromises the testing.
4.10 Improvement
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4.10.1 The laboratory continually improves the effectiveness of its management system through the
use of the quality policy, quality objectives, audit results, analysis of data, corrective and
preventive actions, and management review.
4.10.2 The laboratory has implemented a continual improvement philosophy within the
management system. Every employee in the laboratory is encouraged to suggest new ideas
for improving services, processes, systems, productivity, and the working environment.
4.10.3 Opportunities for improvement of operations and processes are identified by managers on a
continual basis from ongoing feedback on operations and through management reviews.
Opportunities for improvement of services are identified by anyone within the organization
including Sales and Marketing.
4.10.4 Inputs for improvement opportunities may be obtained from the following sources: customer
feedback; market research and analysis; employees, suppliers, and other interested parties;
internal and external audits of the management system; records of service nonconformities;
data for process and service characteristics and their trends.
4.10.5 Opportunities for improvement may also be identified on a special project basis. Examples
include, but are not limited to, improving usefulness of bench space; reducing excessive
inspection/testing; reducing excessing handling and storage; reducing test/calibration
failures.
4.10.6 Opportunities for improvement from daily feedback on operational performance (i.e., internal
audits, customer feedback, and test/calibration failures) are evaluated by the Technical or
Quality Manager. Typically, they are implemented through the corrective and preventive
action system.
4.10.7 Opportunities for improvement from analysis of longer-term data and trends are evaluated
and implemented through the management review process. They are prioritized with respect
to their relevance for achieving quality objectives. When opportunities for improvement are
no longer supported by the current policy and objectives, management will establish new
quality objectives, and possibly change the policy. Longer-term improvement projects are
initiated through the management review process, as well as the corrective and preventive
action system.
4.10.8 Service improvement opportunities are evaluated by management. They are implemented
through the supervisor of the laboratory who ensures that the improvements are validated and
appropriate level of quality control is performed on an ongoing basis.
4.11 Corrective Action
4.11.1 General policy.
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4.11.1.1 Problems with the quality management system or technical operations of the
laboratory may be identified through a variety of activities, such as control of
nonconforming work, internal or external audits, management reviews, feed-back
from customers, or staff observations. Appropriate authority is designated for the
implementation of corrective actions and includes cause analysis, selection and
implementation of corrective action, and monitoring of actions.
4.11.1.2 Corrective action investigations are documented and required changes to
operational procedures are implemented. The corrective action request (CAR),
investigation and resolution are recorded in the CAR database.
4.11.2 Cause analysis.
4.11.2.1 Corrective action always begins with an investigation to determine the root cause(s)
of the problem. Potential causes of the problem could include customer
requirements, the samples, sample specifications, methods and procedures,
personnel skills and training, consumable materials, or equipment and its
calibration.
4.11.3 Selection and implementation of corrective actions.
4.11.3.1 After determining the cause(s) of the problem, potential corrective actions are
identified. The most likely action(s) (this includes practical and/or reasonable) are
selected and implemented to eliminate the problem and to prevent recurrence. It
should be noted that any corrective actions taken to eliminate the cause(s) of
nonconformities or other departures are to a degree appropriate to address the
magnitude of the problem and commensurate with the risks encountered (Note – in
plain language, this means determine whether the benefit outweighs the cost).
Controls are applied to prevent recurrence. The laboratory documents and
implements the required changes resulting from corrective action investigations.
4.11.4 Monitoring of corrective actions.
4.11.4.1 After implementing the corrective action(s), the laboratory monitors the results to
ensure that the actions taken have been effective in overcoming the problems
originally identified. Monitoring is assigned to an appropriate individual such as
the originator of the CAR or the originator’s manager. Changes resulting from
corrective action are documented.
4.11.5 Additional audits.
4.11.5.1 Where the identification of nonconformities or departures casts doubts on
compliance of policies, procedures, regulations, international quality standards, the
appropriate areas of activity are promptly audited in accordance with section 4.14.
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4.11.5.2 Special audits follow the implementation of corrective actions to confirm their
effectiveness. A special audit is only necessary when a serious issue or risk to the
business is identified. Special audits are carried out by trained and qualified
personnel who are [whenever resources permit] independent of the activity to be
audited. See section 4.14 for more details.
4.11.6 Responsibility.
4.11.6.1 Analytical data routinely generated by the laboratory is evaluated to determine
acceptability, including precision and accuracy. Laboratory analyst and supervisors
are responsible for evaluating QC in comparison to acceptance criteria.
4.11.6.2 When data falls outside of the established control limits or acceptance limits for a
given method (as defined by the SOP), that information is evaluated and
appropriate action taken. If a problem is discovered that could merit corrective
action, the person that discovers the problem should discuss with the Quality
Manager the need to initiate a formal corrective action. All Chemtech-Ford, Inc.
employees can recommend corrective action. If it is determined that the problem
merits corrective action, the Quality Manager will initiate the corrective action.
4.11.6.3 The Quality Manager shall review and assign CAR to the supervisor; approve
proposed corrective action; approve close-out of corrective action; monitor CAR
status to ensure complete and timely response; track CAR completion dates; train
and support users of the CAR system if needed.
4.11.6.4 The Technical Supervisor shall review the CAR and determine if corrective action
is warranted; assign the CAR to the responsible personnel for action needed; review
the corrective action to verify implementation; review and evaluate customer
comments and generate CAR if appropriate.
4.11.6.5 Laboratory personnel shall investigate and determine the root cause(s) of
nonconformance and identify and implement timely corrective action.
4.11.6.6 The CAR originator shall initiate the CAR when a need for corrective action is
identified.
4.12 Preventive Action
4.12.1 Opportunities for needed improvement and potential sources of nonconformities, either
technical or with the quality management system shall be identified. If action is required,
action plans are developed, implemented and monitored, to reduce the likelihood of
occurrence of such nonconformities and to take advantage of the improvement opportunities.
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4.12.2 Records of preventive action include details of potential nonconformities, investigation,
preventive action, and follow-up verification. The preventive action procedure includes the
initiation of such actions and application of controls to ensure they are effective.
4.12.3 Preventive action may result from the review of operational procedures and analysis of data.
Analysis of data includes trend analysis, analysis of proficiency testing results, and risk
analysis.
4.12.4 Preventive actions can be designated and documented in the Corrective Action database, in
management meeting notes, or other approved laboratory mechanisms for
recording/monitoring preventive actions.
4.13 Control of Records
4.13.1 General.
4.13.1.1 Records for identification, collection, indexing, access, filing, storage, maintenance,
and disposal of quality and technical records is maintained in Quality Manager
Database and the LIMS. Quality records include reports from internal audits,
management reviews, and corrective and preventing action records. Records are
available to demonstrate conformance to requirements and effective operation of
the Quality Management System. Quality records from suppliers are also
controlled. All records, including test reports, are safely stored and held secure
(either physically or electronically) and in confidence to the customer.
4.13.1.2 All records are to be legible and shall be retained in such a way that they are readily
retrievable in facilities that provide a suitable environment to prevent damage or
deterioration and to prevent loss. Records may be in the form of any type of media,
such as hard copy or electronic media.
4.13.1.3 All records are held secure and in confidence. Access to records is secured through
locked rooms, filing cabinets, and passwords
4.13.1.4 Data is password protected. Backups ensure integrity and availability of
data/information in the event of a system/power failure. An electronic backup
system to prevent loss is implemented. Data is stored locally on the networked
backup server and remotely in a co-hosted facility on a server. Complete backups
of network file server and LISM are made several times a day by the local back-up
server. The LIMS production databases are automatically backed up each evening
onto the server and the co-hosted backup server. The LIMS applications is
supported by software maintenance contracts from the software vendor. The
servers and development workstations are all protected by a UPS system to guard
against power surges/outages. The server data disk drives are mirrored.
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4.13.2 Technical records.
4.13.2.1 Original observations, calculations, derived data and sufficient information to
establish an audit trail, calibration records, personnel records and a copy of each test
report issued are retained for five (5) years. The records for each test or calibration
shall contain sufficient information to facilitate, if possible, identification of factors
affecting the test uncertainty and to enable the test or calibration to be repeated
under conditions as close as possible to the original. The records include the
identity of personnel responsible for sampling, performing of each test and/or
calibration and checking of results.
4.13.2.1.1 Technical records are accumulations of data and information that
result from carrying out tests and/or calibrations and which indicate
whether specified quality or process parameters are achieved. They
may include forms, contracts, work sheets, work books, note books,
instrument printouts, magnetic media, check sheets, work notes,
control graphs, test reports, calibration certificates, customer’s notes,
papers and feedback, and test reports to customers.
4.13.2.1.2 The records for each test contain sufficient information to permit its
repetition. Records include: date of sampling; sample receipt; sample
handling, storage, and disposal; identification of personnel; analyst
proficiency; equipment identification and performance; calibration
records; media performance, where appropriate; test organism batch
number or lot number, where appropriate; results; reports (mailed,
emailed, or faxed); review. Note – the above records may be stored in
separate locations. They are cross referenced for easy retrieval.
4.13.2.2 Observations, data, and calculations are clearly and permanently recorded and
identifiable to the specific job at the time they are made. Handwritten records must
be legible and made with indelible ink immediately after an observation, after data
is collected and/or after calculations are made.
4.13.2.3 Changes to test data are made so as not to obscure or delete the previous data entry.
Mistakes are crossed out with a single line, initialed, dated and the correct value
entered alongside. Mistakes are not erased, made illegible, or deleted. All
alterations to records are signed or initialed by the person making the correction. In
the case of computer-collected data, similar measures are taken to avoid loss or
change of original data. All corrections other than transcription errors must include
the reason for the correction.
4.13.2.4 Records will be maintained or transferred in the event that a laboratory transfers
ownership or goes out of business. In the event that the laboratory changes
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ownership, all records will be transferred to the new owners. The new owner(s)
will then be given the responsibility of maintaining the records. If the laboratory
goes out of business, all hard copy and electronic records will be maintained by the
ownership group at the time of the dissolution of the company for a period of 5
years.
4.13.3 Additional requirements.
4.13.3.1 The laboratory record keeping system documents the history of the sample and
associated data. It includes records to document the laboratory facilities,
equipment, analytical method, sample receipt, sample preparation, data verification,
and inter-laboratory transfers of samples/extracts. Records are appropriately
identified by a descriptive title clearly labeling the record.
4.13.3.2 A record’s retention time refers to how long it is kept before it is either discarded ro
destroyed, or sent for long-term storage. Records are retained on-site for a
minimum of five (5) years. Records may be retained longer than the minimum
retention time for the convenience of the laboratory.
4.13.3.3 Records are readily accessible to individuals requiring information contained in the
record. Records are available to customers for the period agreed to per customer
agreements. Subcontractor’s records, as specified by contract, are made available
upon request. Records are made available to accreditation bodies.
4.13.3.4 Records stored via electronic media will have the necessary hardware/software
necessary for their retrieval.
4.13.3.5 All information necessary for the historical reconstruction of data is maintained by
the laboratory. This includes all raw data, the method referenced, laboratory
sample ID, date and time of analysis, instrument used and operating conditions, any
manual calculations performed, analyst identification, sample preparation, test
results, standards/reagents used, calibration criteria, data calculations, QC protocols
and assessments, software documentation/verification, any changes to automated
entries, method performance criteria, PT results, DOCs, and
names/initials/signatures of all individuals responsible for signing a laboratory
record.
4.13.3.6 All non-automated data generation is recorded legibly and in permanent ink.
4.14 Internal Audits
4.14.1 The internal audit program involves periodic audits conducted according to a predetermined
schedule for each year. Each year different aspects of the Quality System are evaluated. The
schedule is reviewed during the managerial review. All elements of the management system
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including the testing activities are covered on a regular basis. These audits are performed to
verify operations continue to comply with the requirements of this Quality Manual and are
effective.
4.14.1.1 The following areas will be audited on even years: VOA, Semi VOA, LC, Metals,
and Micro.
4.14.1.2 The following areas will be audited on odd years: Inorganics, Receiving, Admin,
QA, and Everyone.
4.14.2 The tracking of internal audit results is maintained in Quality Manager. The Quality Manual,
test procedures, and laboratory results are verified for compliance. It is the responsibility of
the Quality Manager to plan and organize audits as required by the schedule and requested by
management. Audits are carried out by trained and qualified personnel who are (wherever
resources permit) independent of the activity to be audited. Personnel are not to audit their
own activities except when it can be demonstrated that an effective audit will be carried out.
Audits are performed through the aid of a checklist prepared in advance to minimize the
possibility of overlooking any details during the audit. The results of the internal audit are
maintained and accessible.
4.14.3 When audit findings cast doubt on the effectiveness of the operations or on the correctness or
validity of test or calibration results, timely corrective action is taken and customers are
notified immediately if investigations show that laboratory results may have been affected.
Nonconformities that can be resolved easily are to be corrected immediately, ideally during
the audit. Records are made on the audit checklist. Nonconformities that require a more
involved resolution are recorded on a CAR and resolved as described in section 4.11.
Corrective actions and customer notifications must be kept on record for each audit deviation
that casts doubt as described in this section.
4.14.4 Records are made of the activity being audited, the audit findings, and corrective actions that
arise. Management ensures that corrective actions are discharged within an appropriate and
agreed timeline. A report is prepared by the auditor(s). The appropriate manager is
responsible for ensuring that corrective actions are sufficiently recorded. Follow-up is
performed by the auditor and recorded when corrective action is complete and deemed
effective. The audit records are stored in Quality Manager.
4.14.5 Follow-up audits are performed to verify the record and implementation and effectiveness of
the corrective action taken. The follow-up audit is performed at a mutually acceptable time
between the area implementing the corrective action and the auditor.
4.15 Management Review
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4.15.1 Top management periodically (at least annually) conduct a review of the laboratory’s quality
management system and testing and/or calibration activities to ensure their continuing
suitability and effectiveness and to introduce any necessary changes or improvements.
4.15.2 The review takes account of: suitability of policies and procedures; reports from managerial
and supervisory personnel; the outcome of recent internal audits; corrective and preventive
actions; assessments by external bodies; results of PT and inter-laboratory comparisons;
changes in the volume and type of work undertaken, feedback from customers,
recommendations for improvement; and other relevant factors such as quality control
activities, resources, and personnel training. Results of the review feed into the laboratory
planning system and include goals, objectives, and action plans for the coming year.
4.15.3 Findings from management reviews and the actions that arise are recorded. Management
will ensure that the actions are discharged within an appropriate and agreed upon timeline.
5. Technical Requirements
5.1 General
5.1.1 Correctness and reliability of tests and/or calibrations performed have many contributing
factors including human factors, accommodation and environmental conditions, test and
calibration methods and method validation, equipment, and measurement traceability.
5.1.2 When developing test and calibration method and procedures, total measurement and
uncertainty must be accounted for in the training and qualification of personnel, and in the
selection and calibration of equipment. The extent to which the factors contribute to total
measurement uncertainty differs between tests, matrices, and methodologies.
5.2 Personnel
5.2.1 Competence and qualification.
5.2.1.1 Management ensures the competency of all employees including specific equipment
operators, those performing tests and/or calibrations, those evaluating results and
signing test reports. Appropriate supervision is provided for employees undergoing
training. Personnel performing specific tasks are qualified on the basis of
appropriate education, training, experience and/or demonstrated skills, as required.
5.2.1.2 In addition, personnel responsible for the opinions and interpretations included in
test reports also have: relevant knowledge of the technology used in the
performance of analyses, materials, products tested, or the way they are used or
intended to be used and of the defects or degradation that may occur during
sampling, analysis, or use; knowledge of the general requirements expressed in the
legislation and standards; an understanding of the significance of deviations found
with regard to the normal use of the items, materials, or products concerned.
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5.2.1.3 Management defines the minimum levels of qualification and experience necessary
for all posts within the laboratory. The educational and experience requirements for
various laboratory positions are listed in the following sections:
5.2.1.3.1 Laboratory/Technical Director - The minimum requirements for the
laboratory/technical director are:
5.2.1.3.1.1 Bachelor’s degree in the chemical, environmental,
biological sciences, physical sciences or engineering with
at least twenty-four (24) college semester credit hours in
chemistry and at least two (2) years of experience in the
environmental analysis of representative inorganic and
organic analytes for which the Chemtech-Ford, Inc. seeks
or maintains accreditation. A master’s or doctoral degree
in one of the above disciplines may be substituted for one
(1) year of experience.
5.2.1.3.1.2 For microbiological analyses the technical manager must
have a minimum of an associate’s degree with at least four
(4) college semester credit hours in general microbiology
when the laboratory is engaged in microbiological analysis
limited to fecal coliform, total coliform, E. coli and
standard plate count. In addition, the person shall have one
(1) year of experience in microbiological analyses.
5.2.1.3.1.3 If the laboratory maintains a scope beyond fecal coliform,
total coliform, E. coli and standard plate count, then the
technical director must have a bachelor’s degree in
microbiology, biology, chemistry, environmental sciences,
physical sciences or engineering with a minimum of sixteen
(16) college semester credit hours in general microbiology
and biology and at least two (2) years of experience in the
environmental analysis of representative analytes for which
the laboratory seeks or maintains accreditation. A master’s
or doctoral degree in one of the above disciplines may be
substituted for one (1) year of experience.
5.2.1.3.2 Quality Manager – The minimum requirements for the quality manager
are:
5.2.1.3.2.1 Bachelor’s degree and 2 years of experience in
environmental laboratory analysis/operation or an
associate’s degree and 4 years of experience in
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environmental laboratory analysis/operation.
Understanding of quality systems including QA/QC.
Understanding of laboratory operations. Strong
communication skills including to work with a variety of
staff and management.
5.2.1.3.3 Supervisor – The minimum requirements for a laboratory supervisor are:
5.2.1.3.3.1 A bachelor’s degree plus one-year work experience in a
certified environmental laboratory or in a laboratory that
the prospective supervisor demonstrates as one that
substantially meets equivalent quality standards for a
certified laboratory or An associate’s degree in the
biological, chemical, or physical sciences from an
institution of higher education, plus four years work
experience in a certified laboratory or in a laboratory that
the prospective supervisor demonstrates as one that
substantially meets equivalent quality standards for a
certified laboratory.
5.2.1.3.3.2 The supervisor must demonstrate competency to supervise
testing in the areas over which they supervise.
5.2.1.3.4 Technical employees – the minimum for technical laboratory employee
vary as to the position and job requirements. The education
requirements differ based on the job assignment. In general, the
requirements are:
5.2.1.3.4.1 An associate’s or bachelor’s degree in the biological,
chemical, or physical sciences from an institution of higher
education or a high school diploma.
5.2.1.3.4.2 Continued competence is monitored through the use of
blind performance evaluation samples and Demonstrations
of Competency. Where this is not achieved, the need to
retrain personnel is considered. Where a method or
technique is not in regular use, verification of personnel
performance before they undertake tests may be necessary.
5.2.2 Training policies and procedures.
5.2.2.1 Management will formulate the goals with respect to the education and the skills of
the laboratory personnel. The training program is relevant to the present and
anticipated tasks of the laboratory.
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5.2.2.2 Supervisors are responsible for assuring that the employees assigned to them are
trained or otherwise qualified for the assigned jobs. Before assigning an employee
for the first time to a new job, managers shall check their training to verify that the
employee has been trained or qualified for the new job. Supervisors ensure that
records of these assessments and subsequent training are maintained using Quality
Manager.
5.2.2.3 All employees shall bring to the attention of the supervisor their needs for specific
or general training and shall attend and participate in training sessions provided.
5.2.2.4 Upon the date of hire, a new employee goes through introductory training. The new
employee is introduced to a general set of training requirements that must be
completed prior to any further activities in the laboratory. This training includes an
overview of the company’s business philosophy, a walk-through of the facility, a
review of the company’s confidentiality agreement, safety, and data integrity
training. Prior to training in a specific laboratory, it is essential that the employee
have a thorough understanding of the general quality assurance/quality control
principles and objectives that are the underlying foundation of all work performed.
Accordingly, a detailed review of the quality management system is performed with
the Quality Manager, as well as all QA/QC relevant to their job. The employee
must also read the Policy Manual, Safety Manual, and Quality Manual.
5.2.2.5 Training in the laboratory must include all methods or parts of methods and
techniques that personnel are asked to perform. Laboratory specific training
includes detailed training on the instrument(s) which the employee will use,
thorough coverage of the methods and SOPs to be employed, laboratory specific
technique training, and a complete review of all quality control plans, including
data interpretation, calculating, and reporting for that lab area. The trainee must
read the method/SOP, observe the trainer perform the procedure, practice the
procedure, perform the procedure under the direction of the trainer using spiked
samples or PT samples, submit DOCs, perform the procedure under the direction of
the trainer using client samples, read and report the results to the trainer.
Unsatisfactory results require re-training. The trainee is deemed competent by the
trainer when they produce satisfactory results. Further procedures are defined on an
as needed basis at the time training needs are identified for each employee.
5.2.2.6 Minimally, the analyst must demonstrate competency through observation by
management and verification using replicate and/or check samples. For technicians
who perform only parts of the method, confirmation of competency may be verified
by observation only. Re-verification of all personnel must be performed annually on
all methods or techniques pertinent to their job description by use of blind
performance evaluation samples and/or Demonstrations of Competency tests.
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5.2.2.7 All employees are to be advised that they perform their jobs as instructed or as
covered by standard operating procedures (SOP’s). They are NOT allowed to
change tasks covered by SOP’s until the change is approved.
5.2.2.8 Receptionists, managers, representatives, salespersons, and other employees likely
to receive complaints are trained in complaint handling procedures applicable to
their functions.
5.2.3 Employees.
5.2.3.1 Competent permanent or contractual employees are employed in the laboratory. The
technical manager ensures that contractual, additional technical employees, and key
support personnel are supervised and work in accordance to the policies and
procedures of this Quality Manual. Testing must be either performed or supervised
by an experienced person qualified by the experience and/or degree level
requirements from section 5.2.1.
5.2.4 Job descriptions.
5.2.4.1 Current job descriptions for managerial, technical, and key support personnel
involved in tests and/or calibrations are maintained in this quality manual. See
section 5.2.5. Additional duties may be assigned as appropriate.
5.2.5 Key personnel and responsibilities.
5.2.5.1 Chemtech-Ford, Inc. complies with the managerial staff requirements as identified
by Utah R444-14.
5.2.5.2 The laboratory has designated the following lines of authority. These lines of
authority may have exceptions. The organizational chart is reviewed and updated
as necessary.
 CEO
 President – Reports to CEO.
 Executive Vice President – Reports to CEO.
 Vice President, Quality Manager, Laboratory Director – Reports to Executive
Vice President.
 Deputy Laboratory Director – Reports to Laboratory Director.
 Section Manager – Reports to Laboratory Director or Deputy Laboratory
Director.
 Team Leader – Reports to the Section Manager.
 Analysts & Technicians – Reports to the Team Leader or Section Manager.
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5.2.5.3 Laboratory Director – The Laboratory Director is responsible for the administrative
oversight and overall technical operation of the laboratory. The Laboratory
Directory will:
5.2.5.3.1 Define minimum qualifications, experience, and skills necessary for all
technical employees.
5.2.5.3.2 Review the Quality Managers audit findings and document such
reviews.
5.2.5.3.3 Oversee laboratory technical and support staff.
5.2.5.3.4 Review and approve all new and existing analytical procedures.
5.2.5.3.5 Review and approve all deviations from normal analytical protocols.
5.2.5.3.6 Review external and internal quality control audits and all other relative
documentation/information.
5.2.5.3.7 Perform final review and approval of new laboratory projects including
reports and documents.
5.2.5.3.8 Oversee all aspects of report generation.
5.2.5.3.9 Nominate deputies in case of temporary absence. Unless otherwise
specified, the QM or deputy Lab Director will serve as acting laboratory
director in the director's absence.
5.2.5.3.10 Review laboratory resources and capabilities prior to accepting new non-
routine project work that may affect or adversely tax the present capacity
of the laboratory.
5.2.5.3.11 Ensure that subcontracted laboratories are capable and appropriately
certified for analytical work sent to them.
5.2.5.4 Quality Manager (QM) – The QM reports directly to the executive team. The QM
has the responsibility for the quality system and its implementation. The Quality
Manager will:
5.2.5.4.1 Have direct access to the highest level of management at which
decisions are taken on laboratory policy and resources, and to the
laboratory director.
5.2.5.4.2 Serve as the focal point for quality assurance and oversee and review
quality control data.
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5.2.5.4.3 Have training or experience in quality systems and quality assurance
procedures and be knowledgeable in the quality assurance requirements
of Utah Rule R444-14.
5.2.5.4.4 Have knowledge of the approved methods used by the laboratory in
order to accurately evaluate laboratory performance.
5.2.5.4.5 Objectively evaluate data and objectively perform assessments without
undue influence.
5.2.5.4.6 Oversee all quality aspects of sample handling, testing, and report
generation.
5.2.5.4.7 Ensure and document through an annual competency check that each
technical employee demonstrates initial and on-going proficiency for the
tests performed by that employee.
5.2.5.4.8 Review and approve all new and existing analytical procedures.
5.2.5.4.9 Review and approve all deviations from normal analytical protocols.
5.2.5.4.10 Schedule, oversee, and be responsible for reviews of the entire technical
operation of the laboratory. This includes conducting annual technical
audits.
5.2.5.4.11 Arrange, when available, analytical participation in inter-laboratory
comparisons and proficiency testing programs. For purposes of
qualifying for and maintaining accreditation, the QM shall arrange for
participation in an external proficiency test program according to Utah
Rule R-444-14 and as identified in the Quality Systems of NELAP.
5.2.5.4.12 Notify laboratory management of deficiencies in the quality system and
monitor corrective actions. Ensure managers review all corrective
actions initiating from their areas of concern, using corrective action
reports as references during QA training meetings.
5.2.5.4.13 Serve as the back-up to the Laboratory Director in the absence of the
Laboratory Director.
5.2.5.5 Section Manager – These managers are responsible for the day-to-day operation of
the laboratory. Their responsibilities include:
5.2.5.5.1 Supervise all technical and non-technical employees.
5.2.5.5.2 Be responsible for the production and quality of all data reported by the
laboratory.
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5.2.5.5.3 Review and approve analytical data generated within the area.
5.2.5.5.4 Develop and submit new methods and operating procedures for approval
by the Laboratory Director and QM.
5.2.5.5.5 Evaluate instrument and personnel needs.
5.2.5.5.6 Ensure that all samples are accepted, analyzed, and reported in
accordance with laboratory SOPs.
5.2.5.6 Team Leader – The Team Leader are responsible for the day-to-day operation of the
teams within their assigned section. Their responsibilities include:
5.2.5.6.1 Report directly to the Section Manager.
5.2.5.6.2 Be responsible for the production and quality of all data reported by
their section.
5.2.5.6.3 Review data generated within their section.
5.2.5.7 Analysts & Technicians – Technical personnel are responsible for the routine
receipt, analysis, and reporting of all laboratory samples. Technical staff will:
5.2.5.7.1 Report directly to the assigned supervisor.
5.2.5.7.2 Perform duties in accordance to laboratory policy and procedures.
5.2.5.7.3 Read, understand, and follow the Quality Manual and all appropriate
SOPs.
5.2.6 Laboratory organizational chart.
5.2.6.1 The official organizational structure is contained in Quality Manager.
5.2.7 Staff management policies.
5.2.7.1 Management authorizes specific personnel to perform particular types of testing, to
issue test reports, to give opinions and interpretations and to operate particular types
of equipment. Records of the relevant competence, educational and professional
qualifications, training, skills and experience of all technical personnel and
contracted personnel are maintained. This information is readily available and
includes the date on which authorization and/or competence was confirmed and the
criteria on which the authorization is based and the confirming authority.
5.2.7.2 Confidentiality – Each employee shall read, understand, and acknowledge that the
analytical work performed in the laboratory demands a high degree of
confidentiality. In a practical sense, this has to do with the potential communication
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of laboratory procedures and analytical results to clients, regulatory agencies, and
other interested parties. All employees must understand that analytical results
legally belong to the client who contracted such work.
5.2.7.3 Telephone Correspondence - A request for analytical results via telephone should
be verified by requesting the name of the requestor (and as applicable the phone
number, FAX number, e-mail address, or mailing address) before releasing data. It
should be clear that the contracting client is the same as the client requesting the
data. For any data request from a client other than the contracting client, the
contracting client must approve its use by the requesting client before release. Such
permission must be documented (requestor, contracting client, date and time of
request, staff member taking request) and placed in the client data file.
5.2.7.4 E-mail and FAX correspondence - Similar guidelines to 5.2.7.3 apply to requests
for results transmitted by e-mail or FAX. Chemtech-Ford, Inc. will keep electronic
records of e-mail/FAX requests and reports for 5 years.
5.2.7.5 “In-Person” Requests - Similar guidelines to 5.2.7.3 apply to clients who appear at
the laboratory in person and request analytical data or other laboratory
documentation. Copies of such reports or documentation may be released only after
determining that the requestor is the contracting party, or has written permission
from the contracting party to release the data.
5.2.8 Validation of Employee Qualifications.
5.2.8.1 It is the responsibility of Chemtech-Ford, Inc. management to ensure that all
employees have demonstrated capability in the activities for which they have been
hired and are responsible. This includes verification that a potential employee
possesses all of the technical, organizational, and communication skills prior to
employment; and that, once hired, each employee continues to upgrade his
knowledge and skills.
5.2.8.2 Each new employee is required to read, sign, and understand all comprehensive
employment documents provided at time of employment. These documents verify
the position's required skills as well as educating the employee in all aspects of the
company's operations and policies. These documents include, but are not limited to
containing:
 An attestation that all educational qualifications and technical and
communication skills requirements have been fulfilled and reviewed by
management.
 A Confidentiality Agreement.
 An Ethics Statement.
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 A Harassment Prevention Policy.
 An attestation that the employee has read, acknowledged, and understood the
Chemtech-Ford, Inc. Quality Manual.
 An attestation that the employee has read, understood, and agreed to perform
the most recent version(s) of the test method(s) for which the employee is
responsible.
 Demonstrations of Capability for all technical competencies required.
 An explanation of the Chemtech-Ford, Inc. Laboratory Information
Management System (LIMS) and its functions.
5.2.8.3 New employees are apprised of all laboratory security systems and the Training
Files to be kept by each employee.
5.2.8.4 Specialized training sessions will be routinely held to 1) review current policies and
procedures; 2) institute new policies and procedures; 3) review particular technical
skills, Quality Assurance topics, or corrective actions; and 4) institute cross
training. These training sessions/courses will be documented in each employee's
training file.
5.2.8.5 Prior to the initiation and acceptance of test results from an employee on any test
method, satisfactory demonstration of capability is required. Following the
completion of all capability demonstration work, the initial analytical work of any
new employee will be carefully reviewed for accuracy, thoroughness, and
timeliness by the laboratory supervisor. Correct and accurate entry of data into the
LIMS will also be monitored. Once the supervisor is satisfied of the technical
competency of the new employee, a less rigorous review of the employee's skills
and generated data will be required.
5.2.9 Data integrity training.
5.2.9.1 Statement of confidentiality - Each employee shall sign a Confidentiality
Agreement, which describes the understanding of such laboratory confidentiality
and acknowledges the penalties for failing to follow established laboratory
procedures regarding confidentiality.
5.2.9.2 Improper, Unethical, and Illegal Actions - It is the policy of Chemtech-Ford, Inc.
and its employees to perform their duties in a consistently legal and ethical manner.
A high level of ethical behavior is characterized by, but not limited to, dealing
honestly and forthrightly with all clients and co-workers, maintaining data integrity,
open and timely treatment of inaccurate, invalid, or misreported analytical data, and
abiding by all pertinent rules, regulations, company policies, and standard operating
procedures. Deliberate violations of such behavior will result in disciplinary action
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up to and including termination, the consequences of which could additionally lead
to direct liability and legal action against the responsible individual. It is the
responsibility of each Chemtech-Ford, Inc. employee to report any observed
violation of this policy. This observation may result from a visual or studied review
of protocol, generated data, or reported information. Laboratory management will
review the evidence of any such reported violation; confirmation that such a
violation occurred will result in severe disciplinary action, up to and including
termination and possible legal action.
5.2.9.2.1 Serious violations of Chemtech-Ford, Inc.’s ethical policy include, but
are not limited to:
 Changing a reported value in the LIMS database without proper
support of documentation.
 Intentionally misrepresenting data generated by instrument or
calculation.
 Recording invalid or otherwise altered data to make the analysis
conform to "expected" levels.
 Recording invalid or otherwise altered data at someone else's
suggestion or insistence.
 Recording invalid or otherwise altered data to satisfy quality
assurance acceptance criteria.
 Manually integrating chromatographic data to satisfy quality
assurance acceptance criteria.
 Withholding information that was noted during sample receipt or
analysis.
 Purposefully destroying a sample prior to the completion of
analysis.
 Willfully circumventing the sample disposal Standard Operating
Procedure.
5.2.9.2.2 Each Chemtech-Ford, Inc. employee is required to participate in a
training session within two weeks of employment. The training will
include Chemtech-Ford’s ethical policies, examples of unethical
behaviors, and penalties for non-compliance. The new employee will be
required to sign an attestation statement as a condition of employment
which will again define Chemtech-Ford’s policies and penalties.
5.2.9.2.3 Each year, or more frequently if needed, each Chemtech-Ford, Inc.
employee is required to attend ethical training to review company
policies and penalties. At the conclusion of the training, each employee
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will be required to sign an attestation called an Ethical Attestation
Statement that summarizes the employee's ethical and legal
responsibilities. This Statement acknowledges that penalties exist for
deliberately violating this policy.
5.2.9.2.4 In order to promote an atmosphere of integrity, management will
reiterate at routine staff meetings the importance of reporting discovered
errors and the insistence that such reporting will not necessarily result in
personal punishment, even though the company may suffer financially.
5.2.9.2.5 Furthermore, management will institute internal proficiency testing
(blind and double blind samples) where applicable; QC meetings whose
emphasis is on appropriate and inappropriate laboratory technique and
instrument/data manipulation will be held routinely to address this topic.
5.2.9.3 Manual Integration - In keeping with Chemtech-Ford’s policy of producing data of
the highest possible quality, integrations performed in the laboratory must be
generated by fully calibrated instruments and not altered in an unsubstantiated
manner. Improper manual integrations performed for the purposes of meeting
quality control criteria or any other reason are not allowed. Such unsubstantiated
integrations are subject to possible disciplinary action by laboratory management.
If a manual integration is necessary, the integration produced after manual
integration shall both be labeled and present in the raw data package. The intent is
to demonstrate the results of the integration are appropriate and according to good
laboratory practices. It is recommended that a short explanation be provided if an
unusual integration has to be made. All manual integrations are subject to strict
scrutiny to ensure that they are performed appropriately. Analysts are advised that
they must be prepared at any time to defend a manual integration. When there is a
question to the validity of the manual integration by the analyst, then they should
discuss the integration with their supervisor. Supervisors should regularly review
the manual integrations of employees. Manual integrations are noted in the raw
data package. Typically, these are denoted by an “m” next to the integrated area or
concentration.
5.2.9.4 Undue Pressure - An appropriate working atmosphere will be provided at
Chemtech-Ford, Inc. so that all employees will be free from any commercial,
financial, or other undue pressures, which might adversely affect the quality of their
work. If a Chemtech-Ford, Inc. employee feels that his or her work has been
affected by undue pressure of any sort, the following recourses are available:
5.2.9.4.1 The employee may report the source of the pressure(s) affecting lab
performance to his or her supervisor, or to the laboratory director or
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owner if the employee believes notifying the supervisor will be
ineffective or problematic.
5.2.9.4.2 The employee may generate a Corrective Action Form. This form will
specify those requests, behaviors, or other pressures, which adversely
affect the quality of the employee's work. The form will then follow
normal review channels through the laboratory in order to be resolved.
5.3 Accommodation and Environmental Conditions
5.3.1 Facility
5.3.1.1 Laboratory facilities are appropriate to allow for the proper performance of
analytical testing. This may include, but not limited to, energy sources, lighting,
heating, ventilation and any other environmental conditions. Appropriate care is
taken to ensure that the environment does not invalidate the results or adversely
affect the required quality of any measurement. The technical requirements for
accommodation and environmental conditions that can affect the results of tests and
calibrations are documented. Central laboratory supplies and services, such as
water purification systems, air supply, vacuum source, and sample storage, are
appropriate to facilitate proper performance of tests.
5.3.2 Monitoring
5.3.2.1 Critical environmental conditions are monitored, controlled and recorded as
required by the relevant specifications, methods, and procedures or where they may
influence the quality of the results. Tests and calibrations are stopped when the
environmental conditions jeopardize the results of the tests and/or calibrations.
Laboratories are ventilated to reduce the levels of contamination, lower humidity,
and control temperature. Laboratory test areas are heated and air-conditioned as
appropriate. Bench tops and floors are made of impervious, smooth, and easily
cleaned materials.
5.3.3 Separation of Incompatible Activities
5.3.3.1 Effective separation between neighboring areas is made when the activities are
incompatible. Measures are taken to prevent cross-contamination. Reference
materials and certified reference materials must be kept separated from samples
(log-in and storage). Sample log-in and storage must be segregated, ideally in a
separate area from the testing laboratory, and include proper sanitation to exclude
the possibility of cross-contamination. Segregation of activities is achieved through
time and space allocations.
5.3.4 Controlled Access
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5.3.4.1 Access to and use of areas affecting quality of the tests is defined and controlled.
Access to the laboratory is restricted to authorized personnel only. The authorized
personnel are made aware of the intended use of the area, the restrictions imposed
on working within such areas, and the reasons for imposing the restrictions. The
laboratory is broken down into the following areas:
5.3.4.1.1 Sample Receiving – The sample receiving area is designed to be
independent of the other laboratory areas. The sample receiving area is
designed with a convenient access from the out-of-doors. This access is
controlled allowing security of the laboratory and sample storage. The
sample receiving area may also be used for preparing and shipping of
containers to clients.
5.3.4.1.2 Volatiles Laboratory – The volatiles laboratory is located within a climate
controlled area away from the main laboratory in order to eliminate
solvent cross-contamination from other areas of the laboratory. Access to
this laboratory is limited to authorized personnel only. All GC/MS
volatiles work is performed in this area.
5.3.4.1.3 Inorganic Chemistry Laboratory – The inorganic chemistry laboratory
consists of a centrally located spacious rooms equipped with several
large benches for analytical work. Conventional wet techniques such as
gravimetric, colorimetric, titrimetric are performed here. Several fume
hoods are located within the rooms to provide ease of sample
preparation.
5.3.4.1.4 Wastewater Laboratory – This laboratory is adjacent to the inorganic
chemistry laboratory and contains the necessary equipment required to
perform various wet chemistries.
5.3.4.1.5 Metals Laboratory – The metals analysis laboratory contains all of the
metals analytical equipment. Samples are prepared for metals analysis in
the metals prep area adjacent to the laboratory, thus reducing the
possibility of instrument contamination. The metals laboratory is
designed for ICP, ICP/MS, and Hg cold-vapor instrumentation.
5.3.4.1.6 LC, GC, and Semi-volatile GC/MS Laboratory – The preparation lab
contains standard fume hoods and ample bench space for sample
extraction. The LC, GC, and Semi-volatile GC/MS instrument laboratory
has several benches with LC, GC, and GC/MS instrumentation and
supplies.
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5.3.4.1.7 Microbiology Laboratory – The microbiology laboratory is a separate
room that is climate-controlled with ample bench space on which to
perform the required analytical procedures. The laboratory contains its
own supplies and storage facilities for ease of analysis and for prevention
of contamination.
5.3.4.1.8 Sample Storage – Samples remaining in the sample analysis stream are
located within their respective holding areas (refrigerators, etc.) until
required analyses have been complete. All inorganic and organic samples
are kept for a maximum of six weeks in storage throughout the laboratory.
5.3.5 Good Housekeeping.
5.3.5.1 Measures are taken to ensure good housekeeping in the laboratory. Special
procedures are followed when necessary. Controlled use of cleaning and pest
control materials is exercised. The laboratory complies with the local health and
safety requirements.
5.4 Environmental Methods and Method Validation
5.4.1 General
5.4.1.1 Methods and procedures used for all tests and/or calibrations are appropriate as per
sampling, handling, transport, storage and preparation of items to be tested and an
estimation of the measurement of uncertainty as well as statistical techniques for
analysis of test data where appropriate.
5.4.1.2 Instructions on the use and operation of all relevant equipment and on the handling
and preparation of items for testing and/or calibration are available. All instructions,
standards, manuals and reference data relevant to the work of the laboratory are
maintained current and readily available to personnel. Deviation from test and
calibration methods must be documented, technically justified, authorized, and
accepted by the customer. There are SOPs for sample handling, storage,
preparation of test items, QA/QC procedures such as media QC, incubation times
and temperatures, equipment calibration and maintenance, process control QC, and
standards for approving / rejecting results. These may be combined with or separate
from the method.
5.4.2 Selection of Methods
5.4.2.1 Test and/or calibration methods, including methods for sampling, meet the needs of
the customer and are appropriate for the tests and/or calibrations it undertakes.
Preference is given to reference methods published as international, national, or
regional standards. The laboratory ensures that the latest edition of a standard is
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used unless it is not appropriate or possible to do so. When necessary, the standard
is supplemented with additional details to ensure consistent application. Methods
that have been published either in international, national, or regional standards, or
by reputable technical organizations, or in relevant scientific texts or journals, or as
specified by the manufacturer are selected when the customer does not specify the
method to be used. The ability of the laboratory to achieve satisfactory
performance against documented performance characteristics is verified before
samples are analyzed.
5.4.2.2 The customer is informed when the method proposed by the customer is considered
to be inappropriate or out of date.
5.4.3 Laboratory Developed Methods
5.4.3.1 Introduction of test and calibration methods developed internally is a planned
activity and is assigned to qualified personnel equipped with adequate resources.
Plans are updated as development proceeds and ensures effective communication
among all personnel involved.
5.4.3.2 Methods developed in-house are validated and authorized before use. Where
available, Certified Reference Materials (CRMs) are used to determine any
systemic bias, or where possible, results are compared with other techniques,
preferably based on different principles of analysis. As applicable, determination of
uncertainty is part of this validation process and is essential for ongoing quality
control.
5.4.3.3 Laboratory-developed methods or methods adopted by the laboratory may also be
used if they are appropriate for the intended use and if they are validated. The
customer is informed as to the method chosen. The laboratory confirms that it can
properly operate standardized methods before introducing the tests or calibrations.
If the standardized method changes, the confirmation is repeated.
5.4.4 Non-Standard Methods
5.4.4.1 Utilization of non-standard methods is subject to agreement with the customer and
includes a clear specification of the customer’s requirements and the purpose of the
test. The developed method is validated appropriately before use. Discussion and
agreement for the use of non-standard methods is recorded as part of contract
review procedures.
5.4.4.2 All non-standard and new tests are validated for their intended purpose. Qualitative
test methods must be validated to demonstrate estimated sensitivity and specificity,
relative accuracy to official methods (if appropriate), positive and negative
deviation, limit of detection, matrix effect, repeatability, and reproducibility.
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5.4.4.3 Quantitative test methods are validated to demonstrate specificity, sensitivity,
relative accuracy, positive and negative deviation, repeatability, reproducibility, and
limit of determination.
5.4.4.4 For new methods where procedures are developing rapidly, especially for
emergency situations, it may be necessary to circumvent normal validation
procedures. Minimally, this must be a demonstrated recovery in replicate.
5.4.4.5 New test and/or calibration methods are documented prior to providing test and/or
calibration results to customers and contain at least the following information:
5.4.4.5.1 Appropriate identification.
5.4.4.5.2 Scope.
5.4.4.5.3 Description of the type of item to be tested or calibrated.
5.4.4.5.4 Parameters or quantities to be determined.
5.4.4.5.5 Apparatus and equipment, including technical performance
requirements.
5.4.4.5.6 Reference standards and reference materials required.
5.4.4.5.7 Environmental conditions required and any stabilization period needed.
5.4.4.5.8 Description of the procedure, including:
5.4.4.5.8.1 Affixing identification marks, handling, transporting,
storing and preparing of items.
5.4.4.5.8.2 Ensuring checks are made before the work is started.
5.4.4.5.8.3 Checking that the equipment is working properly and,
where required, calibrating and adjusting the equipment
before each use.
5.4.4.5.8.4 Listing method of recording the observations and results.
5.4.4.5.8.5 Indicating any safety measures to be observed.
5.4.4.5.9 Criteria and/or requirements for approval/rejection (quality control plan)
5.4.4.5.10 Data to be recorded and method of analysis and presentation.
5.4.4.5.11 Uncertainty or procedure for estimating uncertainty.
5.4.4.6 Once the method has been developed, a Standard Operating Procedure (SOP) is
written.
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5.4.5 Validation of Methods
5.4.5.1 Performance Characteristics.
5.4.5.1.1 Validation of a method establishes, by systematic laboratory studies, that
the performance characteristics of the method meet the specifications
related to the intended use of the test results. The performance
characteristics of a validation plan includes, as applicable, selectivity
and specificity, range, linearity, sensitivity, limit of detection, limit of
quantitation, accuracy, precision, reporting limit, repeatability,
reproducibility, recovery, confirmation techniques, criteria for the
number of samples tested to validate method as per defined scope of
method, action levels where defined by regulation, and quality control
incorporating statistics as applicable.
5.4.5.1.2 Performance characteristics that are selected take into account the
intended use of the method, whether for screening, confirmatory
analysis, or quantitation. The design, verification of the method and
documentation procedures for validation are planned and conducted by
qualified personnel, equipped with adequate resources. This section lists
a few acceptable validation procedures. The choice of the procedure
depends on the extent of the deviation from the published method.
5.4.5.1.3 Validation of methodology is a value judgment in which the
performance parameters of the method are compared with the
requirements for the test data. A prerequisite for a valid method is that
data produced by the method must attain a state of statistical control.
Such a state is obtained when the mean value of a large number of
individual values tends to approach a limiting value called the limiting
mean. Methods may be validated by one or more alternative procedures.
Some of these procedures are described below. Apparent differences can
be analyzed statistically to confirm their significance. In all cases, the
reasons for choosing one or more alternatives must be documented.
5.4.5.1.3.1 Analysis of standard reference materials (SRM) that are
identical or almost identical to the test samples.
5.4.5.1.3.2 In the absence of suitable SRMs, analysis of reference
materials that are similar in all respect to the test samples;
the use and validity of this reference material must be
documented.
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5.4.5.1.3.3 Using an alternative method to measure the same parameter
provides a very high level of confidence if results are
confirmed.
5.4.5.1.3.4 Recovery studies by the addition of a known concentration
of the parameter of interest to some of the replicates being
measured.
5.4.5.1.4 The parameters to be determined include the scope of the method and
any known interferences, detection limit, the range of concentration
where the method is valid, and precision and bias. Judgement is
required to determine if some or all of the above is required.
Requirements will depend largely on the extent of deviation from the
original method.
5.4.5.1.5 Developments in methodology and techniques require methods to be
changed from time to time. The difference in performance between
revised and obsolete methods is established so that it is possible to
compare old and new data. Where a change in method involves only
minor adjustments, such as sample size, or different reagents, the
amended method is validated and the changes brought to the attention of
the accreditation body at the next accreditation audit. Where the
proposed change involves technology or methodology, the laboratory
seeks the approval of the accreditation body.
5.4.5.2 Fit for use.
5.4.5.2.1 The laboratory validates non-standardized methods, laboratory-
designed/developed methods, standardized methods used outside their
intended range, and amplifications of standard methods to confirm that
the methods are fit for the intended use. The validation is as extensive as
is necessary to meet the needs in the given application or field of
application. The laboratory records the results obtained, the procedure
used for the validation, and a statement as to whether the method is fit
for the intended use. Validation records are kept. Included in these
records is the validation procedure. The procedure used for the
validation is likely to vary between different methods. Therefore, the
procedures included in the laboratory records are not as detailed as a
typical SOP, but are sufficient enough to re-create how the method was
validated.
5.4.5.2.2 The techniques used for the determination of the performance of a
method may include: calibration using reference standards or reference
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materials; comparison of results achieved with other methods; inter-
laboratory comparisons; systematic assessment of the factors influencing
the result; assessment of the uncertainty of the results based on scientific
understanding of the theoretical principles of the method and practical
experience. When changes are made in the validated non-standard
method, the influence of such changes carried out is documented and if
appropriate a new validation is performed.
5.4.5.3 Customer’s needs.
5.4.5.3.1 The range and accuracy of the values obtainable from validated methods
as assessed for the intended use is relevant to the customer’s needs.
Validation includes the specification of the requirements, determination
of the characteristics of the methods, the comparison of the requirements
with the values of the characteristics of the method, and a statement on
the validity. As method development proceeds, regular review is
required to verify that the needs of the customer are still being fulfilled.
Changing requirements requiring modifications to the development plan
are approved and authorized. Validation is always a balance between
costs, risks, and technical possibilities.
5.4.6 Estimation of Analytical Uncertainty
5.4.6.1 Calibration.
5.4.6.1.1 Physical, chemical, and biological standards are calibrated or
characterized by qualified subcontractors. Repeatability and
reproducibility data are components of measurement uncertainty and are
determined as a first step towards producing estimates of this parameter.
The uncertainty of measurement may be made available on the
certificate of analysis or calibration certificate from a subcontractor. In-
house calibrations include procedures for uncertainty of measurement
estimates where practicable. Quality control measurement data may be
used to determine analytical uncertainty.
5.4.6.2 Testing.
5.4.6.2.1 In certain cases, it is not possible to undertake metrologically and
statistically valid estimations of uncertainty of measurement. In these
cases, the laboratory attempts to identify all the components of
uncertainty and make the best possible estimation, and ensure that the
form of reporting does not give an exaggerated impression of accuracy.
Reasonable estimation is based on knowledge of the performance of the
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method and on the measurement scope and makes use of previous
experience and validation data. It is important to understand the major
factors of uncertainty and provide appropriate control for all such
factors. Concurrent analysis of reference materials or control samples
with the test portion can be performed in place of purely mathematical
estimation of uncertainty. If possible, the reference material or control
sample shall be of identical or similar matrix as the matrices routinely
tested by the test method. The uncertainty of the method can be
estimated for the class of matrix and the variation described as the
uncertainty in testing the specific matrix class at the average amount of
analyte detected.
5.4.6.2.2 The degree of rigor needed in an estimation of uncertainty of
measurement depends on factors such as requirement of the test method,
requirement by the customer, and if there are narrow limits on which
decisions on conformity to a specification are based. In cases where a
well-recognized test method specifies limits to the values of the major
sources of uncertainty of measurement and specifies the form of
presentation of calculated results, the laboratory is considered to have
satisfied the estimation uncertainty of measurement by following the
reporting instructions for calibration and batch QC.
5.4.6.3 Uncertainty Components.
5.4.6.3.1 When estimating the uncertainty of measurement, all uncertainty
components that are of importance in the given situation are taken into
account using accepted methods of analysis. Sources contributing to the
uncertainty include, but are not necessarily limited to, the reference
standards and reference materials used, methods and equipment used,
the environmental conditions, the item being tested or calibrated and the
operator. The predicted long-term behavior of the tested and/or
calibrated item is normally not taken into account when estimating the
measurement uncertainty.
5.4.7 Control of Data
5.4.7.1 Calculations and data transfers.
5.4.7.1.1 Calculations and data transfers are subject to appropriate checks in a
systematic manner. Test data are approved through the following
arrangements by the QM, supervisor, lab director, peer etc.: checks to
determine accuracy of calculations, conversions, and data transfers;
checks for transcription errors, omissions, and mistakes; checks to
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determine consistency with normal or expected values. For those
analyses where manual data reduction is required, it is performed
according to the instructions provided in the test method or SOP.
5.4.7.2 Computers and automated equipment.
5.4.7.2.1 When computers or automated equipment are used for the acquisition,
processing, manipulation, recording, reporting, storage or retrieval of
test or calibration data, the laboratory ensures the following:
5.4.7.2.1.1 Computer software developed by the user is documented in
sufficient detail and suitably validated or otherwise checked
as being adequate for use.
5.4.7.2.1.2 Procedures are established and implemented for protecting
the integrity of data; such procedures include, but are not be
limited to, integrity and confidentiality of data entry or
collection, data storage, data transmission, and data
processing.
5.4.7.2.1.3 Computers and automated equipment are maintained to
ensure proper functioning and are provided with the
environmental and operating conditions necessary to
maintain the integrity of test and calibration data.
5.4.7.2.1.4 Data is securely maintained by preventing unauthorized
access to, and unauthorized amendment of, computer records.
5.4.7.2.2 Data generated using computer software programs that are interfaced
directly to instruments incorporates all dilutions and calculations,
thereby eliminating the need for manual data reduction.
5.4.7.2.3 Commercially developed software in general use within their designated
application range may be considered to be sufficiently validated.
5.5 Calibration Requirements
5.5.1 Required Equipment.
5.5.1.1 The laboratory is furnished with all items for sampling, measurement and test
equipment required for the correct performance of the tests and/or calibrations
(including sampling, preparation of test and/or calibration items, processing and
analysis of test and/or calibration data). When equipment is used outside the
laboratory’s permanent control, it ensures that the requirements of this Quality
Manual are met. Equipment is used in an environment appropriate to its proper
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performance. All equipment required by a test is described in each method,
including the equipment’s tolerances. A current list of equipment is maintained in
Quality Manager.
5.5.2 Required Accuracy.
5.5.2.1 Equipment and software used for testing, calibration, and sampling are capable of
achieving the accuracy required and comply with specifications relevant to the tests
and/or calibrations concerned. Calibration programs are established for key
quantities or values of the instruments where these properties have a significant
effect on the results. When received, equipment, including that used for sampling, is
checked to establish that it meets the laboratory’s specification requirements,
complies with the relevant standard specifications, and is checked and/or calibrated
in accordance with section 5.6 before use. The procedures for checking newly
received equipment are as determined by manufacturers’ specification and/or those
determined by the laboratory during procurement.
5.5.3 Authorized Personnel.
5.5.3.1 Equipment is operated by authorized personnel. Up-to-date instructions on the use
and maintenance of equipment (including any relevant manuals provided by the
manufacturer of the equipment) are readily available for use by the appropriate
laboratory personnel. Access to laboratory equipment is controlled to ensure that
only authorized personnel use equipment.
5.5.4 Unique Identification.
5.5.4.1 Each item of equipment used for testing and calibration is uniquely identified when
practicable. Typical identification includes instrument type, make, model, serial
number or other unique markings. Measuring and testing equipment includes any
instrument that could affect the quality of test results. Components that can be
interchanged between various instruments are tracked in equipment logbooks but
are not assigned individual identification.
5.5.5 Inventory and Maintenance Records.
5.5.5.1 Records are maintained for each item of equipment significant to the tests and/or
calibrations performed. The records include the following, where available or
applicable:
5.5.5.1.1 Identity of the item of equipment (and its software).
5.5.5.1.2 Manufacturer’s name, type identification, and serial number and/or other
unique identification.
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5.5.5.1.3 Date received.
5.5.5.1.4 Date placed into service.
5.5.5.1.5 Checks that equipment complies with the specification.
5.5.5.1.6 Current location, where appropriate.
5.5.5.1.7 The manufacturer’s instructions, if available, or reference to their
location.
5.5.5.1.8 Dates, results and copies of reports and certificates of all calibrations,
adjustments, acceptance criteria, and due date of next calibration.
5.5.5.1.9 Maintenance carried out to date (including calibration).
5.5.5.1.10 Damage, malfunction, modification or repair to the equipment.
5.5.5.2 A database is used to capture the above inventory information. The above
information related to service and maintenance is kept in Quality Manager.
5.5.6 Equipment Procedures.
5.5.6.1 The handling, transport, storage, use, and maintenance of equipment is outlined in
the manufacturer’s manual. Specific requirements are outlined in a standard
operating procedure for the instrument or equipment type. All handling, transport,
storage, packaging, preservation, and delivery of equipment is verified by
laboratory personnel using the appropriate standard operating procedures or
manufacturer’s specifications. The manufacturer’s manual is critical in describing
the safe handling requirements of the equipment, to avoid any damage, alteration,
contamination, change of integrity or reliability and condition of the equipment (or
samples). The manufacturer’s manual also provides guidance for suitable
environmental conditions for the calibrations, inspections, measurements and tests
performed. Pre- and post-testing checks verify the performance of an instrument
during its operation and could reveal the occurrence of measurement drift.
5.5.6.2 The laboratory equipment is classified in one of four categories. These categories
are:
5.5.6.2.1 General Service Equipment – Equipment which is not used for making
measurements or with minimal influence on measurements such as hot
plates, stirrers, non-volumetric glassware and glassware used for rough
volume measurements such as measuring cylinders. Laboratory heating
or ventilation systems also fall under this category.
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5.5.6.2.2 Volumetric Equipment – Equipment such as flasks, pipettes, and
burettes, etc.
5.5.6.2.3 Measuring Instruments – Equipment such as thermometers, timers,
spectrometers, chromatographs, electrochemical meters, and balances,
etc.
5.5.6.2.4 Computers and Data Processors – The computer connected to the
measuring instruments and software used to control those instruments.
5.5.6.3 General service equipment is maintained by performing cleaning and safety checks
as necessary. Calibrations or performance checks will be necessary where the
setting can significantly affect the test or analytical result.
5.5.6.4 The correct use of volumetric equipment is critical to analytical measurements and
is suitably maintained as specified in laboratory procedures. For the highest
accuracy, measurements can often be made by mass rather than by volume.
Attention is paid to the possibility of contamination arising from the equipment or
cross-contamination from previous use. The type used, cleaning, storage and
segregation of volumetric equipment are critical, particularly for trace analyses
when leaching or adsorption can be significant.
5.5.6.5 The performance of an instrument is checked out and appraised by a qualified
person before use. This may involve a visual inspection and verification of its
operation, including the zero and full-scale calibration. Correct use, combined with
periodic servicing, cleaning, and calibration will not necessarily ensure an
instrument is performing adequately. Where appropriate, periodic performance
checks are carried out. The frequency of such performance checks is determined by
the relevant SOP and/or experience based type and previous performance of the
equipment. Intervals between checks are shorter than the time the equipment has
been found to take to drift outside acceptable limits. The standardization of
instruments is performed using reference standards when these are available. This is
done before the instrument is used to produce analytical test results.
5.5.6.6 Calibrations are performed as specified in the reference SOP are conducted under
the same instrumental and chemical conditions as those that will exist during the
measurement process. The frequency of calibration depends on the accuracy
requirements of the investigation and the stability of the instruments. Daily
calibration checks are recommended when the instrument is in daily use; calibration
checks are performed immediately prior to a series of measurements at other times.
For unstable instruments, the calibration is checked prior to each series of
measurements, in between measurements, and after the last measurement as
specified in the referenced analytical SOP.
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5.5.6.7 Operating manuals and supplementary procedures are available to operators.
Deviations from established procedures are documented to an extent appropriate to
repeat the procedures at a later date. Special procedures relating to security and file
management, including archiving, file repair, and file backups are outlined in
section 4.13. The computers and their software are considered validated when
correct operation (or expected results) occurs after the input of well characterized
parameters. The degree of validation necessary depends on the exact use of the
computer, including testability, traceability, maintainability, and repeatability.
When software is updated, a record is kept of the revision history.
5.5.7 Out-of-Service Equipment.
5.5.7.1 Equipment that has either been subjected to overloading or mishandling, or gives
suspect results, or has been shown to be defective or outside specified limits, is
taken out of service, clearly marked, and appropriately stored until it has been
repaired and shown by calibration or test to perform correctly. Routine testing
work is completely discontinued on equipment that even shows minor
nonconformance. Not only do we do this for ethical reasons in support of our
customer, but minor nonconformance is often indicative of major breakdowns in
expensive equipment. These breakdowns need to be avoided wherever possible.
5.5.7.2 Out of service equipment is clearly marked. The laboratory examines the effect of
the defect or departure from specified limits on previous test and/or calibrations and
institutes the Control of Nonconforming Work procedure as outlined in section 4.9.
5.5.8 Calibration Status.
5.5.8.1 When appropriate, equipment requiring calibration is labeled to indicate the
calibration status and/or operational status and the date when re-calibration is due.
Calibration status is stored in Quality Manager.
5.5.9 Return to Service.
5.5.9.1 When equipment goes outside the direct control of the laboratory for a period, the
laboratory ensures that the function and calibration status of the equipment are
checked and validated and shown to be satisfactory before the equipment is
returned to service. The procedures used to check and ensure that the function and
calibration status of the equipment are satisfactory before the equipment is returned
to service are outlined in the manufacturer’s equipment manual. Any additional
quality control checks are outlined in the Quality Control section of the appropriate
test method.
5.5.10 Periodic Checks.
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5.5.10.1 When intermediate checks are needed to maintain confidence in the calibration
status of equipment, these checks are carried out periodically according to defined
procedure. Internal quality control checks are specified in individual test methods
that are located in the appropriate laboratory areas thereby providing procedures for
intermediate checks.
5.5.11 Correction Factors.
5.5.11.1 Calibrations that give rise to a set of correction factors are updated along with all
copies of this data. The updating of correction factors, including all copies, is
assured by following the appropriate test method or SOP. It is the responsibility of
the QM to ensure that all copies are updated.
5.5.12 Safeguards Against Adjustments.
5.5.12.1 Test and calibration equipment, including hardware and software, are safeguarded
from adjustments that invalidate test and/or calibration results/status. Safeguards
against adjustment for laboratory equipment include: detailed SOPs and
manufacturer’s manuals on the operation of the equipment; policies permitting
only fully trained and competent personnel to operate equipment; access to the
laboratory is restricted to authorized personnel. Safeguards against adjustment for
software includes: password protection for important files and packages; access to
the laboratory is restricted to authorized personnel; An electronic audit trail is
maintained on for the changes made in the LIMS software.
5.5.13 Support Equipment.
5.5.13.1 Devices that may not be the actual test instrument, but are necessary to support
laboratory operations, such as balances, ovens, refrigerators, freezers, incubators,
and water baths are subject to the same requirements as the test instruments. This is
not a comprehensive list of all support equipment, but rather a short example of
what is considered to be support equipment.
5.5.13.1.1 The result of calibration or verification must be within the specified
requirements for which the equipment is used. If any equipment fails to
meet the requirements, the equipment is removed from use until
repaired. If a correction factor is applied, that factor is documented in
Quality Manager.
5.5.13.1.2 All support equipment must be maintained in working order. Each piece
of support equipment has a maintenance log within Quality Manager.
All maintenance activities, including service calls, are documented there.
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5.5.13.1.3 Each day that balances, ovens, refrigerators, freezers, incubators, and/or
water baths are used, this equipment must be verified for acceptability
for continued use.
5.5.13.1.4 Temperature measuring devices are verified at least annually using a
NIST traceable reference. If the temperature measuring device is used
over a range of 10oC or less, a single point verification is acceptable. If
it is used over a range of greater than 10oC, then the verification brackets
the range of use.
5.5.13.1.5 Volumetric measuring devices are verified as follows:
5.5.13.1.5.1 Glass microliter syringes and Class A glassware are exempt
from these verification requirements.
5.5.13.1.5.2 Disposable or single use equipment is verified once per lot
prior to, or in conjunction with, its first use.
5.5.13.1.5.3 Mechanical devices are verified at least quarterly. Those
used at more than one volume are verified at volumes
bracketing their range of use as well as the midpoint.
5.5.13.1.5.4 All other support equipment is checked for accuracy prior
to, or in conjunction with, its first use.
5.5.13.1.6 All other support equipment is calibrated or verified at least annually.
5.5.13.1.7 Raw data records to document the performance of support equipment are
stored in Quality Manager.
5.6 Measurement Traceability
5.6.1 General. Test and/or calibration equipment for subsidiary measurements (e.g., for
environmental conditions) having a significant effect on the accuracy or validity of the result of
the test, calibration, or sampling are calibrated before being put into service. All measurement
and test equipment having an effect on the accuracy or validity of tests is calibrated and/or
verified before being put into service. The program includes a system for selecting, using,
calibrating, checking, controlling, and maintaining measurement standards, reference standards
used as measurement standards, and measuring and test equipment used to perform tests and
calibrations. Procedures are documented where appropriate. All measurements that play a
defining role in testing accuracy are based directly or indirectly on reference standards,
reference materials, certified reference materials, or other standards or materials having
appropriate traceability. Records are maintained in the LIMS for each standard. These records
include (as applicable) supplier, grade, lot number, and concentration; dates of preparation or
verification; measurements of weights, volumes, time intervals, temperatures, pressures, and
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related calculations; relevant processes; verification results; identification of personnel involved.
Reagents prepared in the laboratory are labelled to identify substance, strength, solvent (where
not water), and date of preparation and expiration. The person responsible for the preparation of
the reagent is identified either from the label or from records.
5.6.2 Calibration. The program for calibration equipment is designed and operated to ensure that
calibration measurements are traceable to the System International (SI) units of measurement.
Traceability of measurement is assured by the use of calibration services from laboratories that
can demonstrate competence, measurement capability and traceability. The calibration
certificates issued by these laboratories show that there is a link to a primary standard or to a
natural constant realizing the SI unit by an unbroken chain of calibrations. The calibration
certificates contain the measurement results including the measurement uncertainty and/or a
statement of compliance with an identified metrological specification. Calibration laboratories
accredited to ISO 17025 are considered competent to provide the appropriate calibration
services. Traceability to SI units of measurement may be achieved by reference to an
appropriate primary standard or by reference to a natural constant the value of which, in terms
of the relevant SI unit, is known. The term “identified metrological specification” means that it
must be clear from the calibration certificate against which specification the measurements have
been compared with, by including the specification or by giving an unambiguous reference to
the specification. When the terms “international standard” or “national standard” are used in
connection with traceability, it is assumed that these standards fulfil the properties of primary
standards for the realization of SI units. Certificates of all reference standards, measuring
equipment, or certified reference material used are maintained to ensure traceability. Where
traceability to national standards of measurement is not applicable, the laboratory provides
satisfactory evidence of correlation of results, for example by participation in a suitable program
of inter-laboratory comparisons or proficiency testing.
5.6.2.1 Instrument Performance Evaluation. General calibration of laboratory instruments
falls into two categories: 1) calibration which is conducted on a routine basis as part
of the analytical procedure prior to each use; and 2) periodic, scheduled calibration of
instruments and gauges against known standards to ensure the continuing precision
and accuracy of such instruments. All instrumentation must be demonstrably
calibrated and evaluated for appropriateness before analysis is initiated. Divergence
from acceptable benchmark criteria requires correction before analyses may be
performed. The instrument performance evaluation material may be a standard
spiked into the solvent used for analysis, but it is not extracted as if it were a
sample.
5.6.2.2 Calibration. As applicable to the method, calibration curves are established for each
parameter using known concentrations of standards. Generally, a correlation
coefficient of better than 0.995 constitutes an acceptable calibration. Method-specific
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calibration requirements are included in individual SOPs. In this case, the analytical
method will take precedence.
5.6.2.3 Continuing Calibration. Prior to use each day, the initial calibration must be verified.
Typically, one of the mid-point calibration standards are analyzed and the results are
compared to the expected results. If the results fall within the method acceptance
limits, then analysis can proceed. If the results are not within the acceptance limits,
then the problem must be corrected prior to analysis of samples. Some methods
require that samples be bracketed by valid opening and closing calibration standards.
When bracketing is required, only results between valid calibration verification
standards can be used. Reportable analytical results are those within the calibration
range of the parameter. In general, values above the highest standard are not
reported. The lowest reportable value is the MRL. Instrumental calibration will be
verified both initially and during sample analysis or at a rate that the established
method requires. The continuing calibration (may be substituted by the check
standard) may be made with standards independent from that used for instrumental
calibration. The calibration check must agree within established limits with the
calibration or the instrument is re-calibrated. If not, the cause of the discrepancy is
identified, corrected, and documented.
5.6.2.4 Initial Calibration Verification. An ICV is a well-characterized material that is run,
at a minimum, with each calibration. The ICV must be obtained from a documented
second source from that used for the calibration. In order to assess the performance
of the method, the ICV is run in the same manner as the other calibration standards.
If the results are not within acceptable limits, the source of the problem is evaluated.
Continual failure indicates there is a problem with the system, the ICV standard or the
calibration standards. Prior to analysis, the ICV must pass method criteria.
5.6.2.5 Calibration Policy. The calibration policies and procedures set forth in this section
apply to all instruments requiring scheduled calibrations against traceable standards,
including: analytical and test equipment in the laboratory, temperature measurement
equipment, balances, weights, thermometers, pH meters, etc. The standards used in
the laboratory measurement system will be calibrated against higher-level, primary
standards having certified accuracy. NIST or other equivalently-recognized
standardization will certify these higher-level standards. Calibration standard
reagents purchased from commercial vendors will be required to have a certificate of
analysis. Whenever a certified, calibration standard is available from NIST,
commercial vendors will be required to establish traceability of the certificate of
analysis to the certified standard.
5.6.3 Testing.
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5.6.3.1 Uncertainty. The requirements given above apply to measuring and test equipment
with measuring functions used, unless it has been established that the associated
calibration uncertainty contributes little to the total uncertainty of the test result. When
this situation arises, the laboratory ensures that equipment used can provide the
accuracy of measurement needed. The extent to which the requirements above are
followed depends on the relative contribution of calibration uncertainty to the total
uncertainty. If calibration is the dominant factor, the requirements are strictly
followed. If, however, calibration is not one of the major contributors to the total
uncertainty, other ways for providing confidence may be used.
5.6.3.2 Traceability. Where traceability to SI units of measurement is not possible and/or not
relevant, other means for providing confidence in the results are applied such as the
use of suitable reference materials certified to give a reliable characterization of the
material; mutual-consent standards or methods which are clearly specified and agreed
upon by all parties concerned; and/or participation in a suitable program of inter-
laboratory comparisons or proficiency testing. Reliable characterization involves an
estimate of recovery. The laboratory participates in proficiency testing and/or check
sample programs. The list of programs is maintained in Quality Manager.
5.6.4 Reference Standards and Reference Materials.
5.6.4.1 Reference Standards. Reference standards are obtained or calibrated by a body that
can provide traceability. Such reference standards of measurement held by the
laboratory are used for calibration only and for no other purpose, unless it can be
shown that their performance as reference standards would not be invalidated.
Reference standards are obtained from ISO certified vendors, if applicable. Where
commercially available, the traceability of reference standards is to a national standard
of measurement.
5.6.4.1.1 The purity and traceability of all standards utilized in the analytical
process is critical to the quality of laboratory generated data. Certified
standards are purchased from well-established and reputable vendors,
and are traceable to the National Institute of Standards and Technology
(NIST). All reference standards are logged into the laboratory LIMS
system. LIMS assigns the standard a unique number. Where applicable,
the description, department, expiration date, prepared/received date,
prepared/received by, solvent, vendor, and lot number are recorded in the
appropriate fields. The certificate of analysis is attached.
5.6.4.2 Reference Materials. Where possible, reference materials are traceable to SI units of
measurement, or to certified reference materials. Internal reference materials are
checked as far as is technically and economically practicable. Reference materials,
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including calibration standards, used in chemical measurement are prepared so that the
point of measurement is similar or equivalent to that of the samples. The matrix, prior
to the addition of the analyte does not have a detectable concentration of the analyte.
Reagents used in the preparation of reference materials, including calibration standards
are of certified purity. Where possible, the traceability of reference materials is to a
national or international standard of measurement. Internal reference materials are
checked as far as technically and economically practicable.
5.6.4.2.1 All reference materials are logged into the laboratory LIMS system. LIMS
assigns the standard a unique number. Where applicable, the description,
department, expiration date, prepared/received date, prepared/received by,
solvent, vendor, and lot number are recorded in the appropriate fields. The
certificate of analysis is attached.
5.6.4.3 Intermediate Checks. Checks needed to maintain confidence in the calibration status
of reference, primary, transfer or working standards and reference materials are carried
out according to defined procedures and schedules. The control check standards used
to verify the accuracy of all the other standards are prepared independently from all
the other standards used to establish the original calibration. These control check
standards are preferably prepared from a separate lot # or source. In some cases,
where the first two source standards agree but the results are called into question, then
it may be appropriate to obtain an additional source for verifications.
5.6.4.3.1 Standards are purchased from more than one vendor to allow for
independent source cross checks of standards during the analytical
process. Stock and working standards are checked frequently for signs
of degradation. Working reagent and standard solutions for inorganic
analyses are made from reagent grade solids and standardized with
primary standards according to the test method. Dilutions of the stock
solutions are made with Type I deionized water and high purity acids
exclusively. Certified, multi-component, metals stock solutions are
purchased. Dilutions of the stock solutions are made with Type I
deionized water and ultra-high purity acids exclusively. Standard
solutions for organic analyses require very pure standards and solvents.
Hence, pesticide quality or better solvents and reagents are required for
most determinations.
5.6.4.4 Transport and Storage. The manufacturer recommendations for reference standards
and reference materials are referred to for safe handling, transport, storage, and use
of reference standards and reference materials in order to prevent contamination or
deterioration and in order to protect their integrity.
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5.6.4.4.1 Reference standards and accompanying certificates are stored and used
in a manner consistent with preserving the calibration status. Particular
consideration is given to any storage advice given in the documentation
supplied with the standard. Instructions for preparation and
standardization of the standards or materials are cited in the appropriate
test method SOP.
5.6.4.4.2 Prepared or working standard solutions are labeled immediately after
preparation with the identity, concentration, date prepared, expiration
date, and the person who prepared it. The shelf life of a prepared
standard will be dependent on the chemical stability of the solution
under proper storage and preservation conditions. If the test method
specifies a shelf life, that shelf life is not exceeded. In the absence of
guidance in the method, shelf lives are established on a case by case
basis (typically 1 year for a stable solution that is frequently used or 5
years for a stable solution that is infrequently used). Reagents are not
measured directly from the reagent bottle. An approximate amount of
reagent needed is placed in a clean receptacle, then an exact
measurement from this aliquot is obtained. Excess reagent is never
returned to the reagent bottle. Excess is discarded. Spatulas or spoons
are never inserted into a bottle that contains solid material. If solids do
not shake out, a sterile stick is used to loosen. The cap of container is
replaced tightly and any spills are cleaned immediately.
5.6.4.4.3 Secondary standards prepared prior to the expiration date of a primary
stock standard are assigned an expiration date as recommended by the
applicable method or from some other suitable guidance. The expiration
date of the secondary standard does not need to be the same as the
expiration date of the primary standard.
5.6.4.5 Documentation and Labeling of Standards, Reagents, and Reference Materials.
5.6.4.5.1 The records for all standards, reagents, reference materials, and media
are stored in the LIMS. This includes the manufacturer/vendor, the
Certificate of Analysis or purity (if available), the date of receipt, and
recommended storage conditions.
5.6.4.5.2 If an expiration date is provided by the manufacturer or vendor, this date
is recorded on the original container. If one is not provided, the
laboratory assigns an expiration date of 5 years from the date received.
5.6.4.5.3 All standard, reference material, and reagents prepared by the laboratory
are logged into the LIMS in the same manner as a stock. The LIMS
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tracks which stock was used in the preparation, how it was prepared,
who prepared it, when it was prepared, and when it expires.
5.6.4.5.4 All standards, reference materials, and reagents, whether stock or
prepared by the lab, are labeled with the unique LIMS number as well as
the expiration date.
5.6.4.5.5 Reagents are prepared to meet the requirements of the method as
described in the method SOP.
5.6.4.5.6 Standards, reference materials, and reagents are not used after the
expiration date unless their reliability has been verified.
5.6.4.5.6.1 A standard, reference material, or reagent may be verified
by using it in an appropriate quality control sample and
comparing the recovery to that obtained from a source that
is not past its expiration date. If the recovery is such that it
passes all method specific requirements, the expiration date
may be extended by one month, unless it is reasonable to
extend it further. Documentation of the passing recoveries
as well as an explanation regarding the extension of the
expiration date is recorded in the LIMS.
5.7 Collection of Samples
5.7.1 Chemtech-Ford, Inc. does not currently perform sampling.
5.8 Handling Samples and Test Items
5.8.1 Procedures.
5.8.1.1 Samples, reagents, and standards are stored so as to ensure their integrity by
preventing against deterioration, contamination, and loss of identity.
5.8.1.2 To ensure consistency and efficiency, sample handling (e.g., filtration, decantation,
centrifugation, sample splitting), preservation, storage, and transportation
procedures must be properly and accurately documented.
5.8.1.3 Preservatives are prepared from high-grade chemicals and care is taken to ensure
that the sample is not contaminated by impurities residing in the added preservative.
5.8.1.4 Samples are stored in coolers during transportation. The refrigeration target is 0 – 4
± 2 °C for those samples requiring cooling as part of the preservation process. It is
employed for the maintenance of the quality of both preserved and unpreserved
samples.
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5.8.1.5 Samples are tightly closed and packed to prevent spillage or breakage. Labels
bearing the sample identification must be attached to each sample container. For
subcontracted samples, a chain of custody must accompany the samples and the
shipping reference number is entered into LIMS to allow for in-house sample
tracking.
5.8.1.6 Samples are received at the laboratory and a chain of custody form is initiated.
5.8.1.7 The sample receptionist accepts samples and performs a series of checks and
inspections to assure all necessary sampling and preservation requirements have
been met, sample integrity has been maintained during transit, and that all necessary
information has been supplied.
5.8.1.8 Upon successful completion of this system of checks, samples are logged, handled
and protected to avoid contamination and stored at 0 – 4 ± 2º C.
5.8.1.9 Laboratory personnel are notified of sample arrival and test requirements through
the LIMS. Short analysis holding times or rush status require communications with
the laboratory section leaders.
5.8.1.10 Samples are maintained in such a way to assure limited and authorized access only.
Sample storage units are located in areas of the laboratory that are routinely
occupied by staff. Samples that have been removed from storage for analysis are
not left unattended. Visitors to the laboratory are accompanied by laboratory staff
at all times. The facility is secured at the close of business each day.
5.8.2 Identification of Test and/or Calibration Items.
5.8.2.1 Test and/or calibration items are systematically identified as they arrive at the
laboratory. The identification is retained throughout the life of the item in the
laboratory. The system is designed and operated so as to ensure that items cannot be
confused physically, or when referred to in records or other documents. The system
accommodates a sub-division of groups of items and the transfer of items within and
from the laboratory when appropriate. Sample labelling indicates the unique
identification and conforms to applicable legal requirements. The laboratory has
established and documents a system for appropriate chain-of-custody.
5.8.3 Receipt.
5.8.3.1 Upon receipt of the test or calibration item, any abnormalities or departures from
normal or specified conditions, as described in the relevant test or calibration method,
are recorded. When there is any doubt as to the suitability of an item for test or
calibration, or when an item does not conform to the description provided, or the test
or calibration required is not specified in sufficient detail, the laboratory consults the
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customer for further instructions before proceeding and keeps a record of the
discussion.
5.8.3.2 Samples submitted for environmental compliance testing must meet certain thermal
and chemical preservation criteria for proper analysis of samples to occur. Samples
must also be collected in the proper container, have sufficient volume to perform
the tests and received at the laboratory with sufficient time to perform the analysis
within method specified holding times. All samples are evaluated for compliance to
EPA regulatory criteria. If a sample does not meet the regulatory criteria for sample
acceptance, the customer is notified of any anomalies and for advice on whether or
not to proceed with analysis.
5.8.3.3 The sample should conform to applicable regulations or contractual arrangements. The
condition of sample may include or relate to damage, quantity, preparation, packaging,
or temperature. Preparation may include addition of chemical preservative, removal of
moisture, isolation of portion of sample to be tested, homogenization, or subsampling.
Procedures are in place to document that the elapsed time between sampling and
testing does not exceed test method specifications (holding time) once the sample is
received in the laboratory.
5.8.3.4 Personnel in the Sample Receiving Department shall verify proper, full, and
complete documentation, which shall include sample identification, the location,
date and time of collection, collector's name, preservation type, sample type and
any special remarks concerning the sample; proper sample labeling to include
unique identification and a labeling system for the samples with requirements
concerning the durability of the labels (water resistant) and the use of indelible ink;
use of appropriate sample containers; adherence to specified holding times;
sufficient sample volume to perform the necessary tests.
5.8.3.5 Customer Service Personnel shall verify that the login information is complete and
correct. Any anomalies with samples are documented on the “Chemtech Login
report.” This report is supplied to the customer by Customer Service personnel
after samples have been reviewed. Unless otherwise directed by the customer,
Chemtech Ford, Inc. will proceed with the requested analysis. The customer must
contact Chemtech Ford, Inc. within 24 hours of being notified of a deviation to the
requirements listed above. The customer should be aware that deviations from the
prescribed preservations, holding times, and necessary volumes could potentially
invalidate the sample results.
5.8.4 Protection.
5.8.4.1 When items have to be stored or conditioned under specified environmental
conditions, these conditions are maintained, monitored, and recorded. Where a sample,
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or portion of a sample, is to be held secure (e.g., for reasons of record, safety, or value,
or to enable check tests to be performed later), the laboratory has storage and security
arrangements that protect the condition and integrity of the sample.
5.8.4.2 A sampling procedure and information on storage and transport of samples, including
all information that may influence the test or calibration result, is provided to those
responsible for taking and transporting the samples. The laboratory establishes
whether the sample has received all necessary preparation or whether the customer
requires preparation to be undertaken or arranged by the laboratory. Proper
requirements for packaging, environmental conditions, and separation from
incompatible materials are observed. Where samples have to be stored or conditioned
under specific conditions, these conditions are maintained, monitored, and recorded,
where necessary.
5.8.5 Documentation.
5.8.5.1 All samples are logged into the LIMS upon receipt. The LIMS assigned a unique
sample ID for every sample. This LIMS number is linked to the field identification.
A label with the LIMS ID is affixed to the sample bottle identifying the sample. All
analyses performed by the laboratory reference this LIMS number. See also
Sample Receiving SOP.
5.8.6 Sample Acceptance Policy.
5.8.6.1 The sample acceptance policy is described in sections 5.8.1 to 5.8.3. See also
Sample Receiving SOP.
5.8.7 Sample Receipt Protocols.
5.8.7.1 Chemical preservation of samples is checked and documented prior to or during
analysis. See sections 5.8.1 to 5.8.3 for actions taken when a sample does not meet
the acceptance criteria. See also Sample Receiving SOP.
5.8.7.2 The LIMS serves as a permanent chronological record for sample receipt. The
client and project name, date of receipt, LIMS ID code, and person documenting
entries is recorded. Also recorded is the field ID, date and time of sample
collection, requested analyses, and any comments resulting from sample inspection
regarding sample rejection.
5.8.8 Legal Chain of Custody Protocols. Chemtech-Ford, Inc. does not allow for this level of
record keeping and will not accept samples requiring such CoCs.
5.8.9 Sample Storage and Disposal.
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5.8.9.1 Samples that require thermal preservation are stored under refrigeration. Samples
are stored away from standards, reagents, and food. Sample fractions, leachates,
extracts, and other preparation products are stored according to method
specifications.
5.8.9.2 Samples are disposed of per the Waste Management and Disposal SOP .
5.9 Quality Assurance for Environmental Testing
5.9.1 Quality control procedures are utilized to monitor the validity of test and/or calibration
results. These procedures are for each test method utilized in the laboratory. The resulting
data are recorded so that trends are detectable (and where practicable, statistical techniques
are applied to the reviewing of the results). This monitoring is planned and reviewed and may
include, but is not limited to, the following: regular use of certified reference materials and/or
internal quality control using secondary reference materials; participation in inter-laboratory
comparisons or proficiency testing programs; replicate tests or calibrations using the same or
different methods; re-testing or re-calibration of retained items; correlation of results for
different characteristics of an item. The methods utilized from the above list will be
appropriate for the type and volume of the work undertaken. Records are maintained of
assurance activities and any actions taken.
5.9.2 As a guide, for routine analyses the level of internal quality control is typically 5% of the
sample throughput. For more complex procedures, 20% is not unusual and on occasions even
50% may be required. For analyses performed infrequently, a full system validation is
performed on each occasion. This may typically involve the use of a reference material
containing a certified or known concentration of analyte, followed by replicate analyses of
the sample and spiked sample. For analyses undertaken more frequently, systematic quality
control procedures incorporating the use of control charts and check samples are
implemented. These procedures are documented in the "Quality Control" section of each test
method.
5.9.3 Proficiency testing helps to highlight not only repeatability and reproducibility performance
between laboratories, but also systematic errors such as bias. It is important to monitor
proficiency testing results as a means of checking quality assurance and take action as
necessary. Quality Manager maintains a list of all the current proficiency testing programs
the laboratory participates in, monitors the results, and notifies the appropriate personnel of
both problematic and successful results.
5.9.4 Technical personnel use certified reference materials to evaluate test performance on a daily
basis and include daily process control checks. These data are used to evaluate the validity of
the test results.
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5.9.5 Replicate tests may be used if suitable reference material is available. These materials and
proficiency test materials are available for improving repeatability. Re-testing of test items is
performed occasionally at the discretion of the supervisor or when test results seem
anomalous.
5.9.6 Quality Control Procedures. The determination of precision and accuracy is an important
analytical tool in evaluating the quality of generated data. Precision is defined as the ability
to reproduce a value within defined limits. Accuracy is defined as producing the correct
answer. Different methods are employed to measure each of these parameters.
5.9.6.1 Precision - Utilizing duplicate samples and comparing their respective results is the
primary method for the analysis of precision. However, it has no bearing on
accuracy. A result may be precise and inaccurate at the same time. As required by
the method, one duplicate sample is analyzed for each matrix type and method, and
for each sample batch. The relative percent difference (RPD) for each component is
then calculated and compared to the acceptance limits for the matrix and method.
5.9.6.2 Accuracy - Utilizing matrix-matched standards of known concentration and
comparing them to the analyte of interest is the primary method for measuring
accuracy. Participation in independent Performance Testing (PT) studies is also
utilized to monitor accuracy of data in the laboratory.
5.9.6.3 Reproducibility - The tracking of reproducibility ensures that analyses performed at
different times or by different individuals may be acceptably reproduced. This
demonstrates that the method, instrumentation, and analytical technique are resilient
enough to reproduce results within a specified range over time.
5.9.7 Quality Control Samples. The quality control principles contained in this section will be
implemented consistently, dependent upon the type of analysis to be performed and any
associated, specific requirements of such analysis. In addition, the analyst is to use his/her best
judgment to evaluate the use of additional QC bracketing samples which have a difficult
matrix, react differently, or have distinctive client or reporting requirements. The additional
QC can take the form of additional spikes, standards, and/or SRM’s. Sufficient QC should be
performed to insure that the analyst has performed due diligence with regard to QC while
analyzing the sample.
5.9.7.1 Matrix Spike and Matrix Spike Duplicate - Matrix spikes are employed to monitor
recoveries and maintain sample preparation techniques at acceptable levels.
Compounds of interest are added to samples prior to extraction and analysis.
Compound recoveries and reproducibility are then compared with tables of
acceptance for each method. The established acceptance ranges are contained in
each method SOP. This QC procedure provides information about the effect of the
sample matrix on the analyte in question. Generally, a ratio of one spike sample for
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each ten samples for drinking water and for each twenty samples for RCRA and
wastewater analyzed must be maintained. In the event that an analytical run will
have less than ten samples one spike shall accompany the batch. The method SOP
should be consulted to determine the proper frequency.
5.9.7.1.1 Spike Recoveries - Percent spike recoveries range between +3 standard
deviations (SD) of the historical percent recoveries when method-
specified criteria are not available. It is recognized that this will not
always be achievable due to matrix effects. In that case, the data will be
reported and an explanation made concerning the problem. Percent
recovery of matrix spikes is determined by:
Percent recovery = ௌௌோ
ௌ஺ ∗ 100
Where:
SSR = Spiked Sample Result
SR = Sample Result
SA = Spike Added
5.9.7.1.2 Laboratory matrix spikes and matrix spike duplicates must be prepared
and analyzed for each ten samples for drinking water and for each
twenty samples for RCRA and wastewater analyses or as required by the
method SOP. These sample types are not always possible due to the type
of analysis, for example pH. This procedure provides information
regarding the precision of an analysis. The relative difference between
duplicate measurements is assessed using the following equation:
Relative Percent Difference (RPD) = ∣ୈଵିୈଶ∣
ీభషీమ
మ
∗ 100
Where:
D1 = Sample Value
D2 = Duplicate Sample Value
5.9.7.2 Laboratory Control Spikes - Compounds of interest are added to reagent blank
samples prior to preparation and analysis, as required by each method SOP.
Compound recoveries and reproducibility are then compared with tables of
acceptance for each method.
5.9.7.3 Duplicates and Spike Duplicates - Both routine sample analysis and spiked samples
are run in duplicate at a prescribed frequency. The relative percent difference
between duplicate sample analysis and duplicate spike analysis must range between
+ 2 standard deviations (SD) of historical relative percent difference (RPD), when
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method-specified criteria are not available. It is recognized that this will not always
be achievable due to matrix effects. If a matrix effect is confirmed, the data will be
reported and an explanation concerning the problem will be noted on the final
report.
5.9.7.4 Surrogates - Surrogate spike compounds of interest are added to each sample prior
to preparation and analysis. Compound recoveries and reproducibility are then
compared with tables of acceptance for each method.
5.9.7.5 Method and Reagent Blanks - Method blanks must be prepared with each batch of
samples and analyzed to ensure that sample contamination has not occurred. If blank
analyses do not fall within acceptable limits, as noted in the method specific SOP, a
modification of method reagents or cleaning of glassware may need to be
implemented before further analysis is attempted. In addition to method blanks,
reagent blanks shall be prepared whenever the lot number of a reagent used in the
analysis has changed.
5.9.7.6 Internal Standards - Internal standards will be prepared from a solution containing a
known amount of analyte and will be traceable to a certified reference solution.
Internal standard levels spiked into the sample for analysis will be according to
method SOP protocol. During analysis, internal standard intensities will be
monitored and compared to the intensities established in the calibration blank. In
general, intensities should be within 60 – 135% of the original response in the
calibration blank, or as otherwise specified in the method SOP.
5.9.7.7 Quality Control Check Samples - Quality control check samples will be prepared
from a solution containing a known amount of analyte and will be traceable to a
certified reference solution. These solutions will be prepared from a source that is
different from those used for the calibration standards/tuning standards. These
solutions will be used to verify the stability of the analytical curve established for
the current analytical run. After calibration and calibration verification, continued
calibration blanks (CCB) and continued calibration verification samples (CCV) will
typically be analyzed after every 10 samples and at the end of every analytical run
or as defined by the method SOP. Control limits during analysis of these solutions
will be subject to the QA protocol as defined by the method SOP. Quality control
check samples will be used to verify the efficacy of the sample preparation
procedure via the analyses of preparation blanks (PB) and laboratory control
samples (LCS) derived from a certified reagent traceable to a certified reference
material or solution. Laboratory control samples must agree within + 2 standard
deviations of the historical data base, be no greater than + 20 percent of the true
value, or as defined by the method SOP. Where method specific ranges exist, they
may be used.
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5.9.8 Calibration Standards. Calibration Standards will be prepared from a solution containing a
known amount of analyte and will be traceable to a certified reference solution. Calibration
standards will be prepared from a solution that is “second source;” that is, different from the
continued calibration verification (CCV) solution. These solutions are to be utilized for the
calibration/tuning of analytical instruments at the beginning of an analytical run and to be
used for tuning frequency as required by the method SOP protocol. These solutions are also
used to evaluate method MDL’s and effective quantitative ranges (linearity). When required,
these samples will be analyzed as samples with control limits as required by the method SOP
protocol. Selection of appropriate formulae to reduce raw data to final results is included in
the method analyte SOP and is built into the LIMS.
5.9.9 Control charts can be produced by analyte for the evaluation of QA/QC data. The charts are
produced by the LIMS software.
5.9.10 Out-of-Control Situations. On occasion, a quality control sample may fail; i.e., the recovery
for one or more specific analytes may lie outside the acceptable range (creating an "out-of-
control" situation). This failure may or may not affect the acceptability of the analytical run
and the quality of associated generated data. Quality control guidelines have been
established to be used in the evaluation of out-of-control data for each analytical SOP.
Quality control data are analyzed and, where they are found to be outside pre-defined criteria,
planned action is taken to correct and to prevent incorrect results from being reported.
5.10 Reporting of Results
5.10.1 The results of each test, or series of tests are reported accurately, clearly, unambiguously and
objectively, and in accordance with any specific instructions in the test methods. The results
are reported, normally in a test report and include all the information requested by the
customer and necessary for the interpretation of the test results and all information required
by the method used.
5.10.2 Test reports and certificates. Test reports include the following information, as appropriate:
 Title
 Name and address of laboratory, and location where tests were carried out if
different from the address of the laboratory.
 Unique identification of the test report, and on each page an identification in
order to ensure that the page is recognized as a part of the test report.
 Name and address of the customer.
 Identification of the method used.
 Description, condition, and unambiguous identification of the item(s) tested.
 Date of receipt of test items (where this is critical to the validity and
application of the results) and date(s) of performance of the analysis.
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 Reference to sampling procedures used by the laboratory or other bodies
where these are relevant to the validity or application of the results.
 Test results with, where appropriate, units of measurement.
 The name(s), function(s) and signature(s) or equivalent of person(s)
authorizing the test report.
 Where relevant, a statement to the effect that the results relate only to the
items tested.
5.10.2.1 Signing authority for test reports is the responsibility of the Lab Director. Records
for individuals with signing authority for test reports are approved by the Quality
Manager and maintained by same. Analytical reports include the individual page
number and total number of report pages. A statement is included specifying that
the test report is not to be reproduced except in full, without written approval of the
laboratory. Data reported to the customer contains the appropriate significant digits
for each test method. Low level data are identified as being below specified limits
and are flagged with a ‘J’ flag indicating a value found between the MDL and
MRL.
5.10.3 Test reports.
5.10.3.1 In addition to the requirements listed in section 5.10.2, test reports include the
following, where necessary for the interpretation of results.
 Results that are reported on a basis other than as received, such as dry-weight.
 Deviations from, additions to, or exclusions from the test method, and
information on specific test conditions, such as environmental conditions.
 Where relevant, a statement of compliance/non-compliance with requirements
and/or specifications.
 Where applicable, a statement on the estimated uncertainty of measurement of
the test result; information on uncertainty is needed in test reports when it is
relevant to the validity or application of the test results, when a customer’s
instruction so requires, or when uncertainty affects compliance to a specification
limit.
 Where appropriate and needed opinions and interpretations.
 Additional information required by specific methods, customers, or groups of
customers.
 Any non-accredited tests are clearly identified as such.
 Results that are outside the calibration range are clearly identified.
5.10.3.2 In addition to the requirements listed in sections 5.10.2 and 5.10.3.1, test reports
containing the results of sampling include the following, where necessary for the
interpretation of test results.
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 Date and time of sampling.
 Unambiguous identification of substance, matrix, material or product sampled
(including name of manufacturer and lot number as appropriate).
 Location of sampling.
 Reference to sampling plan and procedures used.
 Details of any environmental condition during sampling that may affect the
interpretation of the test results.
 Any standard or other specification for the sampling method or procedure, and
deviations, additions to or exclusions from the specification concerned.
5.10.4 Calibration Certificates. The testing laboratory does not issue calibration certificates. However,
the laboratory often receives calibration services from a calibration laboratory and needs to be
familiar with the information on a calibration certificate. In addition to the requirements listed
in 5.10.2, the calibration certificate could include the following, where necessary for the
interpretation of calibration results.
 The conditions (e.g., environmental) under which the calibrations were made
that have an influence on the measurement results.
 The uncertainty of measurement and/or a statement of compliance with an
identified metrological specification or clauses thereof.
 Evidence that the measurements are traceable.
A calibration certificate (or calibration label) shall not contain any recommendation on the
calibration interval except where this has been agreed with the customer or it is to be used by the
laboratory itself.
5.10.5 Opinions and Interpretations. When opinions and interpretations are included in the test report,
the basis upon which the opinions and interpretations have been made is documented. Opinions
and interpretations are clearly marked as such in the test report. Opinions and interpretations
included in a test report may comprise, but not be limited to the following: opinion on
conformity of the results with requirements; fulfilment of contractual requirements;
recommendations on how to use the results; guidance to be used for improvements. In many
cases it is appropriate to communicate the opinions and interpretations by direct dialogue with
the customer.
5.10.6 Testing and Calibration Results obtained from Subcontractors. Test reports containing the
results of tests performed by subcontractors are clearly identified for the subcontracted results.
The subcontractor reports the results either in writing or electronically to our laboratory.
5.10.7 Electronic Transmission of Results. In the case of transmission of test results by telephone,
facsimile, e-mail, or other electronic or electromagnetic means, the requirements of the policies
and procedures of this Quality Manual continue to apply. Signatures are recorded on file at the
laboratory. Clients may request a hardcopy example of signatures.
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5.10.8 Format of Reports. The format of reports is designed to accommodate each type of test carried
out and to minimize the possibility of misunderstanding or misuse. The layout of the test report
is such that the presentation of the test data facilitates ease of assimilation by the reader.
5.10.9 Amendments to Reports. Material amendments to a test report after issue are made only in the
form of a further document, or data transfer, which includes the statement “Amended Report”.
Such amendments meet all the requirements in this Quality Manual. When it is necessary to
issue a complete new test report, it is uniquely identified and contains a reference to the original
that it replaces. A narrative accompanies the amended report which details the changes in the
report as well as justifications for the change.
5.10.9.1 The label ‘Amended Report Rev. (#), [mm-dd-yyyy]’ shall be added to the LIMS system in
the User Defined Fields of the Sample Control / Work Order. (Example- “Amended Report
Rev. 1, 2/7/2013”).
5.10.9.2 The amended report shall always include a report narrative whether or not the original
report included the narrative.
5.10.9.3 The last item on the report narrative shall be titled ‘Amended Report [Date] Explanation’
and shall include a listing of the changes and the reasons / justifications for the change.
5.10.9.4 The amended report shall be stored in the appropriate electronic Work Order file and on the
WebData website.
6 References
6.1 The NELAC Institute, Volume 1 Management and Technical Requiremetns for Laboratories
Performing Environmental Analysis, Module 2: Quality Systems General Requirements , EL-V1M2-
2016-Rev2.1
7 Appendices
7.1 Appendix 1: List of commonly used acronyms.
BLK Blank
BOD Biochemical Oxygen Demand
BS Blank Spike
CAR Corrective Action Report
CBOD Carbonaceous Biochemical Oxygen Demand
CCB Continuing Calibration Blank
CCV Continuing Calibration Verification
CDOC Continuing Demonstration of Capability
CoC Chain of Custody
CofA Certificate of Analysis
DDI Double Deionized water
DO Dissolved Oxygen
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DUP Duplicate
EB Equipment Blank
FB Field Blank
GC Gas Chromatograph
GC-FID Gas Chromatograph-Flame Ionization Detector
GC-ECD Gas Chromatograph-Electron Capture Detector
GC-MS Gas Chromatograph-Mass Spectrometry
ICB Initial Calibration Blank
ICP Inductively Coupled Plasma
ICP-MS Inductively Coupled Plasma-Mass Spectrometry
ICV Initial Calibration Verification
IDL Instrument Detection Limit
IDOC Initial Demonstration of Capability
IPC Instrument Performance Check
IS Internal Standard
LCS Laboratory Control Standard
LDR Linear Dynamic Range
LIMS Laboratory Information Management System
LOD Limit of Detection
LOQ Limit of Quantitation
MB Method Blank
MDL Method Detection Limit
MRL Minimum Reporting Level
MS/MSD Matrix Spike/Matrix Spike Duplicate
NIST National Institute of Standards and Technology
QA Quality Assurance
QC Quality Control
RPD Relative Percent Difference
SOP Standard Operating Procedures
SPE Solid Phase Extraction
SPLP Synthetic Precipitation Leaching Procedure
SRM Standard Reference Material
SURR Surrogate
TB Trip Blank
TCLP Toxicity Characteristic Leaching Procedure
TKN Total Kjeldahl Nitrogen
TNI The NELAC Institute
TPH Total Petroleum Hydrocarbons
USEPA United States Environmental Protection Agency
UST Underground Storage Tank
ZHE Zero Headspace Extraction

Document No. EM-QA-IP-1129
Revision No. 16
Effective Date: 10/02/2020
Page 1 of 133
Quality Assurance Manual Cover Page
MARLTON (ML)
3000 Lincoln Drive East,
Suite A
Marlton, NJ 08053
NORTH PHOENIX (PX)
1501 W. Knudsen Dr.
Phoenix, AZ 85027
SOUTH SAN FRANCISCO(SSF)
6000 Shoreline Court
Suite 205
South San Francisco, CA 94080
FLORIDA (FL)
6301 NW 5th Way,
Ste. 1410
Ft. Lauderdale, FL 33309
HOUSTON (HS)
10900 Brittmoore Park Dr.,
Suite G
Houston, TX 77041
IRVINE (IV)
17461 Derian Ave. Suite 100
Irvine, CA. 92614
VIRGINIA (VA)
3929 Old Lee Highway,
Unit 91C
Fairfax, VA 22030
DENVER (DE)
4955 Yarrow St.
Arvada, CO 80002
SACRAMENTO (SA)
180 Blue Ravine Rd.
Folsom, CA 95603
CHICAGO (CH)
1815 W. Diehl Rd.
Suite 800
Naperville, IL 60563
LAS VEGAS. (LV)
6100 Mountain Vista St.
Suite 160
Las Vegas, NV 89014
NORTH SEATTLE (SE)
19515 North Creek Pkwy N.
Suite 100
Bothell, WA 98011
ATLANTA (AT)
6500 McDonough Dr.
Suite C-10
Norcross, GA 30093
GLENDALE (GL)
1010 N Central Avenue
Ste. 420
Glendale, CA 91202
SAN DIEGO (SD)
8304 Clairemont Mesa Blvd.,
Ste. 103
San Diego, CA 92111
MONROVIA (MV)
750 Royal Oaks Dr.,
Suite 100
Monrovia, CA 91016
ORLANDO (OR)
5750 S. Semoran Blvd
Orlando, FL 32822
Senior QA Manager
Claudia Palermo
3000 Lincoln Drive E, Suite A
Marlton, NJ 08053
[phone]
QA Manager
Dan Shelby
1501 W. Knudsen Drive
Phoenix, AZ 85027
[phone]
QA Manager
Urooj Sagheer
10900 Brittmoore Park Dr.
Suite G
Houston, TX 77041
(281)-940-2576
www.emlab.com
Facility Distribution No. ___________ Distributed To:_______________________
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Copyright Information:
This documentation has been prepared by Eurofins EMLab P&K solely for their own use and the use of
their customers in evaluating their qualifications and capabilities in connection with a particular project.
The user of this document agrees by its acceptance to return it to Eurofins EMLab P&K upon request and
not to reproduce, copy, lend, or otherwise disclose its contents, directly or indirectly, and not to use if for
any other purpose other than that for which it was specifically provided. The user also agrees that where
consultants or other outside parties are involved in the evaluation process, access to these documents
shall not be given to said parties unless those parties also specifically agree to these conditions.
THIS DOCUMENT CONTAINS VALUABLE CONFIDENTIAL AND PROPRIETARY INFORMATION.
DISCLOSURE, USE OR REPRODUCTION OF THESE MATERIALS WITHOUT THE WRITTEN
AUTHORIZATION OF EUROFINS EMLAB P&K IS STRICTLY PROHIBITED. THIS UNPUBLISHED
WORK BY EUROFINS EMLAB P&K IS PROTECTED BY STATE AND FEDERAL LAW OF THE
UNITED STATES. IF PUBLICATION OF THIS WORK SHOULD OCCUR THE FOLLOWING NOTICE
SHALL APPLY:
©COPYRIGHT 2020 EUROFINS EMLAB P&K, LLC. ALL RIGHTS RESERVED.
Facility Distribution No. ___________ Distributed To:_______________________
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Title Page:
Quality Assurance Manual
Approval Signatures
10/1/2020
West Cluster Leader – Malcolm Moody Date
10/1/2020
Central Cluster Leader – Kamash Pillai Date
10/2/2020
Aerotech Cluster Leader – Joshua Cox Date
10/2/2020
Technical Director – Michael Berg (Deputy for East Cluster Leader)Date
10/2/2020
South Cluster Leader – Balu Krishnan Date
10/1/2020
Quality Assurance Manager - Urooj Sagheer Date
10/1/2020
Quality Assurance Manager - Dan Shelby Date
10/2/2020
Senior Quality Assurance Manager - Claudia Palermo Date
Company Confidential & Proprietary
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Page 4 of 133
SECTION 2. TABLE OF CONTENTS
Sec.
No.Title
2009 and 2016
TNI Standard
Reference
ISO/IEC
17025:2005(E)
Reference
ISO/IEC
17025:2017(E)
Reference
Page
No.
-Quality Assurance Manual Cover Page V1M2 Sec. 4.2.8.3 1
1.0 Title Page 3
2.0 TABLE OF CONTENTS V1M2 Secs.
4.2.8.3-4.2.8.4
8.1.2, 8.2.1 4
3.0 INTRODUCTION, SCOPE AND
APPLICABILITY
V1M2 Sec. 4.2.8.4 11
3.1 Introduction and Compliance References
V1M2 Secs. 1.1;
1.2; 2.0; 3.2; 4.1.2;
4.2.4
4.1.2; 4.2.4 5.3; 5.4;
8.2.4; 8.3.1 11
3.2 Terms and Definitions V1M2 Secs. 3.0;
4.2.4
4.2.4 11
3.3 Scope / Fields of Testing V1M2 Secs. 1.2;
4.2.4
4.1.2; 4.2.4 5.3; 5.4;
8.2.1; 8.2.4 11
3.4 Management of the Manual
V1M2 Secs. 4.2.1;
4.2.7; 4.3.3.2;
4.3.3.3
4.2.1; 4.2.7;
4.3.3.2; 4.3.3.3
5.3 12
4.0 MANAGEMENT REQUIREMENTS V1M2 Sec. 4 8.2.4; 8.2.5 12
4 Overview V1M2 Secs. 4.1.1,
4.1.3; 4.1.5
4.1.1; 4.1.3;
4.1.5; 4.2.6
5.1; 5.2;
5.5; 5.6 ;
6.2.1; 6.2.4
12
4.2 Selection of Personnel 6.2.5 12
4.3 Roles and Responsibilities V1M2 Secs. 4.1.4;
4.1.5; 4.1.6; 4.2.1;
4.2.6; 5.2.4
4.1.3; 4.1.5;
4.1.6; 4.2.1;
4.2.6; 5.2.4
4.1.1 to 4.1.3;
4.1.5; 5.5;
5.6; 6.2.1;
6.2.4; 6.2.6
8.2.2;
13
4.4 Business Continuity and Contingency
Plans
V1M2 Secs. 4.1.5;
4.1.7.2; 4.2.7
4.1.5; 4.2.7 25
5.0 PERSONNEL V1M2 Secs. 5.2;
5.2.1
5.2.1 6.1; 6.2.3 28
5.1 Overview V1M2 Secs. 5.2.2;
5.2.3; 5.2.5
5.2.2; 5.2.3;
5.2.5
6.2.2 28
5.2 Education and Experience Requirements
For Technical Personnel
V1M2 Secs. 5.2.1;
5.2.3; 5.2.4
5.2.1; 5.2.3;
5.2.4
6.2.2 to 6.2.4 28
5.3 Training V1M2 Sec. 5.2.5 5.2.5 4.2.1; 6.2.2;
6.2.4; 6.2.5 32
5.4 Data Integrity and Ethics Training
Program
V1M2 Sec. 4.2.8.1;
5.2.7
4.1.1 32
6.0 ACCOMMODATIONS AND
ENVIRONMENTAL CONDITIONS
V1M2 Sec. 5.3 6.1; 6.3.1 33
6.1 Overview V1M2 Secs. 5.3.1;
5.3.3; 5.3.4; 5.3.5
5.3.1; 5.3.3;
5.3.4; 5.3.5
6.3.1 33
6.2 Environment V1M2 Secs. 5.3.1;
5.3.2; 5.3.3; 5.3.4;
5.3.5
5.3.1; 5.3.2;
5.3.3; 5.3.4;
5.3.5
6.3.1 to 6.3.5 33
6.3 Work Areas V1M2 Secs. 5.3.3;
5.3.4; 5.3.5
5.3.3; 5.3.4;
5.3.5
6.3.1 34
6.4 Building Security V1M2 Sec. 5.3.4 5.3.4 6.3.4 35
7.0 QUALITY SYSTEM 6.1; 8.2.4 36
7 Quality Policy Statement V1M2 Secs. 4.1.5;
4.2.2; 4.2.3; 4.2.8.3
4.1.5; 4.2.2;
4.2.3
8.2.3; 8.6.1 36
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Revision No.: 16
Effective Date: 10/02/2020
Page 5 of 133
Sec.
No.Title
2009 and 2016
TNI Standard
Reference
ISO/IEC
17025:2005(E)
Reference
ISO/IEC
17025:2017(E)
Reference
Page
No.
7.2 Ethics and Data Integrity
V1M2 Secs. 4.1.5;
4.16; 4.2.2; 4.2.8.1;
5.2.7
4.1.5; 4.2.2 4.1.1 to 4.1.3;
4.2.1; 6.2.1;
8.2.2; 8.2.3
37
7.3 Quality System Documentation V1M2 Secs. 4.1.5;
4.2.2; 4.2.5
4.2.2; 4.2.5 8.2.4 38
7.4 QA/QC Objectives for the Measurement
of Data
V1M2 Sec. 4.2.2 4.1.5; 4.2.2 6.2.4 38
7.5 Criteria for Quality Indicators 40
7.6 Statistical Quality Control 40
7.7 Quality System Metrics 43
8.0 DOCUMENT CONTROL V1M2 Secs. 4.2.7;
4.3.1; 4.3.2.2 ;
4.3.3.3; 4.3.3.4
4.2.7; 4.3.1;
4.3.2.2; 4.3.3.3;
4.3.3.4
8.2.4; 8.3.1 44
8.1 Overview 8.2.5; 8.3.1;
8.3.2 44
8.2 Document Approval and Issue V1M2 Secs. 4.3.2;
4.3.2.1-4.3.2.3;
4.3.3.1
4.3.2.1; 4.3.2.2;
4.3.2.3; 4.3.3.1
8.2.5; 8.3.2 44
8.3 Procedures for Document Control Policy V1M2 Secs.
4.3.2.1–4.3.2.2;
4.3.3.1
4.3.2.1; 4.3.2.2;
4.3.3.1
8.2.5; 8.3.2 45
8.4 Obsolete Documents V1M2 Secs.
4.3.2.1–4.3.2.2
4.3.2.1; 4.3.2.2 8.2.5; 8.3.2 45
9.0 SERVICE TO THE CLIENT V1M2 Secs. 4.4.1 -
4.4.4
4.4.1; 4.4.2;
4.4.3; 4.4.4
7.1.1; 7.1.1.4;
7.1.1.5; 7.1.1.8;
7.1.2.1
46
9.1 Overview V1M2 Secs. 4.4.5;
4.5.5; 5.7.1
4.4.5; 5.7.1 46
9.2 Review Sequence and Key Personnel V1M2 Sec. 4.4.5 4.4.5 7.1.1.6 46
9.3 Balancing Lab Capacity and Workload
9.4 Documentation V1M2 Sec. 5.7.1 5.7.1 48
9.5 Special Services V1M2 Secs. 4.7.1-
4.7.2
4.7.1; 4.7.2 7.1.1.3; 7.1.1.7 49
9.6 Client Communication V1M2 Secs. 4.7.1-
4.7.2
4.7.1; 4.7.2 7.1.1.7 49
9.7 Reporting V1M2 Secs. 4.7.1-
4.7.2
4.7.1; 4.7.2 7.1.1.7 49
9.8 Client Surveys V1M2 Secs. 4.7.1-
4.7.2
4.7.1; 4.7.2 7.1.1.7; 8.6.2 49
10.0 SUBCONTRACTING OF TESTS V1M2 Secs. 4.4.3;
4.5.4
4.4.3; 4.5.4 50
10.1 Overview V1M2 Secs. 4.5.1 -
4.5.3; 4.5.5; 5.3.1
4.5.1; 4.5.2;
4.5.3; 5.3.1
6.6.1; 7.1.2.1;
7.1.2.2 50
10.2 Qualifying and Monitoring Subcontractors V1M2 Secs. 4.5.1;
4.5.2; 4.5.3; 4.5.5
4.5.1; 4.5.2;
4.5.3
6.6.1; 7.1.2.1;
7.1.2.2 51
10.3 Oversight and Reporting V1M2 Sec. 4.5.5 52
10.4 Contingency Planning 53
11.0 PURCHASING SERVICES AND
SUPPLIES
V1M2 Sec. 4.6.1 4.6.1 53
11.1 Overview V1M2 Secs. 4.6.2;
4.6.3; 4.6.4
4.6.2; 4.6.3;
4.6.4
6.6.1; 6.6.2 53
11.2 Glassware V1M2 Sec.
5.5.13.1 54
11.3 Reagents, Standards & Supplies V1M2 Secs. 4.6.2;
4.6.3; 4.6.4
4.6.2; 4.6.3;
4.6.4
6.6.1 to 6.6.3 54
11.4 Purchase of Equipment / Instruments /
Software
56
11.5 Services 56
11.6 Suppliers 57
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No.Title
2009 and 2016
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Reference
ISO/IEC
17025:2005(E)
Reference
ISO/IEC
17025:2017(E)
Reference
Page
No.
12.0 COMPLAINTS V1M2 Sec. 4.8 4.8 8.6.1; 8.6.2 58
12.1 Overview 7.9.1 to 7.9.3
8.6.1; 8.6.2; 58
12.2 External Complaints 7.9.2 to 7.9.7
8.6.1; 8.6.2; 58
12.3 Internal Complaints 8.6.1; 8.6.2 59
12.4 Management Review 8.6.1; 8.6.2 59
13.0 CONTROL OF NONCONFORMING
WORK
V1M2 Secs. 4.9.1;
5.10.5
4.9.1; 5.10.5 7.10.1 59
13.1 Overview V1M2 Secs. 4.9.1;
4.11.3; 4.11.5
4.9.1; 4.11.3;
4.11.5
7.10.1 59
13.2 Responsibilities and Authorities V1M2 Secs. 4.9.1;
4.11.3; 4.11.5;
5.2.7
4.9.1; 4.11.3;
4.11.5
7.10.1 60
13.3 Evaluation of Significance And Actions
Taken
V1M2 Secs. 4.9.1;
4.11.3; 4.11.5
4.9.1; 4.11.3;
4.11.5
4.1.5;
7.10.1; 7.10.2;
8.5.3
60
13.4 Prevention of Nonconforming Work V1M2 Secs. 4.9.4;
4.11.2
4.9.2; 4.11.2 7.10.2; 7.10.3;
8.5.3 61
13.5 Method Suspension / Restriction (Stop
Work Procedures)
V1M2 Secs. 4.9.1;
4.9.2; 4.11.5
4.9.1; 4.9.2;
4.11.5
7.10.1; 7.10.2 61
14.0 CORRECTIVE ACTION V1M2 Sec. 4.11 4.1.4; 4.1.5 62
14.1 Overview V1M2 Secs. 4.9.2;
4.11.1; 4.11.2
4.9.2; 4.11.1;
4.11.2; 8.7.1;
8.7.3
7.10.2 8.7.1;
8.7.3; 62
14.2 General V1M2 Sec. 4.11.2;
4.11.3
4.11.2; 4.11.3 7.7.2; 8.5.3;
8.7.1; 62
14.3 Closed Loop Corrective Action Process V1M2 Sec. 4.11.2;
4.11.3; 4.11.4;
4.11.6; 4.11.7;
4.12.2
4.11.2; 4.11.3;
4.11.4; 4.12.2
8.5.3; 8.6.1;
8.7.2 63
14.4 Technical Corrective Actions V1M2 Sec. 4.11.6 8.7.1 65
14.5 Basic Corrections V1M2 Secs. 4.11.1;
4.13.2.3
4.11.1; 4.13.2.3 7.5.2; 8.7.1 65
15.0 PREVENTIVE ACTION /
IMPROVEMENT
V1M2 Secs. 4.10;
4.12.1; 4.12.2
4.10; 4.12.1;
4.12.2
4.1.4 69
15.1 Overview V1M2 Secs. 4.15.1;
4.15.2
4.15.1; 4.15.2 8.6.2 69
16.0 CONTROL OF RECORDS V1M2 Secs. 4.2.7;
4.13.1.1; 4.13.3
4.2.7; 4.13.1.1 8.4.2 70
16.1 Overview V1M2 Secs.
4.13.1.1; 4.13.1.2;
4.13.1.3; 4.13.1.4;
4.13.2.1; 4.13.2.2;
4.13.2.3; 4.13.3
4.13.1.1;
4.13.1.2;
4.13.1.3;
4.13.1.4;
4.13.2.1;
4.13.2.2;
4.13.2.3
8.4.1; 8.4.2 70
16.3 Technical and Analytical Records V1M2 Sec.
4.13.2.2 - 4.13.2.3
4.13.2.2;
4.13.2.3
7.5.1; 8.4.2 74
16.4 Laboratory Support Activities 7.5.2; 8.4.2 75
16.5 Administrative Records 8.4.2 75
16.6 Records Management, Storage and
Disposal
V1M2 Sec. 4.13.3 4.2.1; 8.4.2 75
17.0 AUDITS 76
Internal Audits V1M2 Sec. 4.2.8.1;
4.14; 4.14.1;
4.14.2 ;
4.14.3; 4.14.5;
5.9.1; 5.9.2
4.14.1; 4.14.2;
4.14.3; 5.9.1;
5.9.2
8.6.1; 8.8.1;
8.8.2 76
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Sec.
No.Title
2009 and 2016
TNI Standard
Reference
ISO/IEC
17025:2005(E)
Reference
ISO/IEC
17025:2017(E)
Reference
Page
No.
17.2 External Audits V1M2 Secs.4.14.2;
4.14.3
4.14.2; 4.14.3;
4.14.4
4.2.1; 8.6.1 79
17.3 Audit Findings V1M2 Secs. 4.14.2;
4.14.3; 4.14.5
8.6.1 79
18.0 MANAGEMENT REVIEWS V1M2 Sec. 4.1.6;
4.15; 4.15.1; 4.15.2
4.1.6; 4.15.1;
4.15.2
4.1.4; 8.5.1;
8.6.1; 8.9.1;
8.9.2
80
18.1 Quality Assurance Report 8.5.1 80
18.2 Annual Management Review V1M2 Sec. 4.2.2;
4.15.3
4.2.2 4.1.1, 4.1.4;
4.2.1; 7.1.1.3;
8.2.2;
8.5.1 to 8.5.3;
8.6.1; 8.9.3
80
18.3 Potential Integrity Related Managerial
Reviews
4.1.5; 8.5.1;
8.6.1 81
19.0 TEST METHODS AND METHOD
VALIDATION
V1M2 Sec. 5.4.1 5.4.1 7.2.1.1; 8.2.5 81
19.1 Overview V1M2 Sec. 5.4.1 5.4.1; 5.4.5.1 6.2.3; 7.2.1.1
to 7.2.1.3 81
19.2 Standard Operating Procedures (SOPs) V1M2 Secs.
4.2.8.5; 4.3.3.1;
5.4.2
4.3.3.1; 5.4.2 7.2.1.4 81
19.3 Laboratory Methods Manual V1M2 Sec. 4.2.8.5 6.2.3 81
19.4 Selection of Methods V1M2 Secs. 4.13.3;
5.4.1; 5.4.2; 5.4.3.
V1M4 Secs. 1.4;
1.5.1; 1.6.1; 1.6.2;
1.6.2.1; 1.6.2.2
5.4.1; 5.4.2;
5.4.3; 5.4.4;
5.4.5.1; 5.4.5.2;
5.4.5.3
7.1.1.2; 7.2;
7.2.1.2; 7.2.1.3;
7.1.2.4 to 7.2.1.7;
7.2.2.1 to 7.2.1.7;
7.2.2.1
82
19.5 Laboratory Developed Methods and Non-
Standard Methods
V1M2 Sec. 5.4.2.
V1M4 Sec. 1.5.1
5.4.2; 5.4.4;
5.4.5.2; 5.4.5.3
7.1.1.2;
7.2.1.4 to 7.2.1.7
7.2.2.1; 7.2.2.3;
8.2.5
82
19.6 Validation of Methods V1M2 Sec. 5.4.2.
V1M4 Secs. 1.5.1;
1.5.2; 1.5.2.1;
1.5.2.2; 1.5.3
5.4.2; 5.4.4;
5.4.5.2; 5.4.5.3
7.1.1.2; 7.1.2.4;
7.2.1.6;
7.2.2.1 to 7.2.2.4
85
19.7 Method Detection Limits (mdl) / Limits of
Detection (LOD)
V1M2 Sec. 5.9.3.
V1M4 Secs. 1.5.2;
1.5.2.1; 1.5.2.2
5.4.5.3 7.2.2.3 85
19.8 Verification of Detection Limits V1M2 Sec. 5.9.3 87
19.9 Instrument Detection Limits (IDL)V1M2 Sec. 5.9.3.
V1M4 Sec. 1.5.2.1 87
19.10 Limit of Quantitation V1M2 Sec. 5.9.3 87
19.11 Estimation of Uncertainty of
Measurement
V1M2 Sec. 5.1.1;
5.1.2; 5.4.6
5.1.1; 5.1.2;
5.4.6.1; 5.4.6.2;
5.4.6.3
7.6.1; 7.6.2;
7.6.3 87
19.12 Sample Reanalysis Guidelines V1M2 Sec 5.9.1 5.9.1 88
19.13 Control of Data V1M2 Secs.
5.4.7.1; 5.4.7.2;
5.9.1
5.4.7.1; 5.4.7.2;
5.9.1
7.11.1 to 7.11.6 88
20.0 EQUIPMENT and CALIBRATIONS V1M2 Secs. 5.5.4;
5.5.5; 5.5.6
5.5.4; 5.5.5;
5.5.6; 5.6.1
6.1; 6.4.3;
6.4.6; 6.4.9 92
20.1 Overview V1M2 Secs. 5.5.1;
5.5.2; 5.5.3; 5.5.5;
5.5.10
5.5.1; 5.5.2;
5.5.3; 5.5.5;
5.5.10; 5.6.1
6.4.1;
6.4.4 to 6.4.6;
6.4.9; 6.4.11
92
20.2 Preventive Maintenance V1M2 Secs. 5.5.1;
5.5.3; 5.5.7; 5.5.9
5.5.1; 5.5.3;
5.5.7; 5.5.9;
5.6.1
6.4.1 to 6.4.3;
6.4.6; 6.4.10 92
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Sec.
No.Title
2009 and 2016
TNI Standard
Reference
ISO/IEC
17025:2005(E)
Reference
ISO/IEC
17025:2017(E)
Reference
Page
No.
20.3 Support Equipment V1M2 Secs. 5.5.10;
5.5.11; 5.5.13.1
5.5.10; 5.5.11;
5.6.2.1.2;
5.6.2.2.1;
5.6.2.2.2
6.4.11; 6.4.12;
6.5.1; 6.5.2;
6.5.3
94
20.4 Instrument Calibrations V1M2 Secs. 5.5.8;
5.5.10; 5.6.3.1.
V1M4 Sec. 1.7.1.1;
1.7.2
5.5.8; 5.5.9;
5.5.10; 5.6.1;
5.6.2; 5.6.3.1
6.4.2; 6.4.3;
6.4.6 to 6.4.8;
6.4.11; 6.4.13;
6.4.14; 6.5.1;
6.5.2
96
21.0 MEASUREMENT TRACEABILITY 100
21.1 Overview V1M2 Sec. 5.6.3.1 5.6.2.1.2;
5.6.2.2.2; 5.6.3.1
6.4.14; 6.5.1;
6.5.2; 6.5.3 100
21.2 NIST-Traceable Weights and
Thermometers
V1M2 Secs.
5.5.13.1; 5.6.3.1;
5.6.3.2
5.6.3.1;
5.6.3.2
6.4.14 100
21.3 Reference Standards / Materials V1M2 Secs.
5.6.3.1; 5.6.3.2;
5.6.3.3; 5.6.3.4;
5.6.4.1; 5.6.4.2;
5.9.1; 5.9.3
5.6.3.1; 5.6.3.2;
5.6.3.3; 5.6.3.4;
5.9.1
6.4.14 100
21.4 Documentation and Labeling of
Standards, Reagents, and Reference
Materials
V1M2 Secs.
5.6.4.2; 5.9.3 101
22.0 SAMPLING 103
22.1 Overview V1M2 Secs. 5.7.1;
5.7.3
5.7.1;
5.7.3
7.3.1; 7.3.2;
7.3.3 103
22.2 Sampling Containers 103
22.3 Definition of Holding Time 103
22.4 Sampling Containers, Preservation
Requirements, Holding Times
104
22.5 Sample Aliquots / Subsampling V1M2 Sec. 5.7.1 5.7.1 7.3.1; 7.3.2 104
23.0 HANDLING OF SAMPLES V1M2 Sec. 5.8.1 5.8.1 7.4.1 104
23.1 Chain of Custody (COC)V1M2 Secs. 5.7.2;
5.7.4; 5.8.4;
5.8.7.5; 5.8.8; 5.9.1
5.7.2; 5.8.4;
5.9.1
7.1.1.6; 7.4.1 104
23.2 Sample Receipt V1M2 Secs. 5.8.1;
5.8.2; 5.8.3; 5.8.5;
5.8.7.3; 5.8.7.4;
5.8.7.5
5.8.2; 5.8.3 7.4.3 105
23.3 Sample Acceptance Policy V1M2 Secs. 5.8.6;
5.8.7.2 106
23.4 Sample Storage V1M2 Secs. 5.7.4;
5.8.4
5.8.4 7.4.1; 7.4.4 107
23.5 Hazardous Samples and Foreign Soils 108
23.6 Sample Shipping V1M2 Sec. 5.8.2 5.8.2 7.4.2 108
23.7 Sample Disposal 108
24.0 ASSURING THE QUALITY OF TEST
RESULTS
110
24.1 Overview V1M2 Secs. 5.9.2;
5.9.3
5.9.2 7.7.2 to 7.7.3 110
24.2 Controls V1M2 Secs. 5.9.2;
5.9.3 5.9.2 7.7.1; 7.7.3 110
24.3 Negative Controls V1M2 Secs. 5.9.2;
5.9.3
V1M4 Secs. 1.7.3;
1.7.3.1; 1.7.4.1
5.9.2 7.7.1; 7.7.3
110
Company Confidential & Proprietary
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Document No. EM-QA-IP-1129
Revision No.: 16
Effective Date: 10/02/2020
Page 9 of 133
Sec.
No.Title
2009 and 2016
TNI Standard
Reference
ISO/IEC
17025:2005(E)
Reference
ISO/IEC
17025:2017(E)
Reference
Page
No.
24.4 Positive Controls V1M2 Secs 5.9.2;
5.9.3.
V1M4 Secs. 1.7.3;
1.7.3.2; 1.7.3.2.1;
1.7.3.2.2; 1.7.3.2.3
5.9.2 7.7.1; 7.7.3
112
24.5 Acceptance Criteria (Control Limits)V1M2 Sec. 5.9.3.
V1M4 Secs.
1.7.4.2; 1.7.4.3
7.7.1; 7.7.3
112
24.6 Additional Procedures to Assure Quality
Control
V1M2 Sec. 5.9.3.
V1M4 Sec. 1.7.3.4 7.7.1; 7.7.3 112
25.0 REPORTING RESULTS 114
25.1 Overview V1M2 Secs. 5.10.1;
5.10.2; 5.10.8
5.10.1; 5.10.2;
5.10.8 7.8.1 to 7.8.2 114
25.2 Test Reports V1M2 Secs. 5.10.1;
5.10.2; 5.10.3.1;
5.10.3.2; 5.10.5;
5.10.6; 5.10.7;
5.10.8; 5.10.10;
5.10.11
5.10.1; 5.10.2;
5.10.3.1;
5.10.3.2; 5.10.5;
5.10.6; 5.10.7;
5.10.8
7.8.2.1; 7.8.2.2;
7.8.3; 7.8.5
114
25.3 Supplemental Information for Test V1M2 Secs. 5.10.1;
5.10.3.1; 5.10.5
5.10.1; 5.10.3.1;
5.10.5
7.1.1.3; 7.8.6.1;
7.8.6.2;
7.8.7.1 to 7.8.7.3
116
25.4 Environmental Testing Obtained from
Subcontractors V1M2 Secs. 4.5.5;
5.10.1; 5.10.6 5.10.1; 5.10.6 117
25.5 Client Confidentiality V1M2 Secs. 4.1.5;
5.10.7 4.1.5; 5.10.7 4.2.1 to 4.2.4 117
25.6 Format of Reports V1M2 Sec. 5.10.8 5.10.8 118
25.7 Amendments to Test Reports V1M2 Sec. 5.10.9 5.10.1; 5.10.9 7.8.8.1 to 7.8.8.3 118
25.8 Policies on Client Requests for
Amendments
V1M2 Secs. 5.9.1;
5.10.9
5.9.1; 5.10.1;
5.10.5; 5.10.9
118
26.0 Accreditation and Logo Advertising Policy 119
27.0 Revision History 120
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Effective Date: 10/02/2020
Page 10 of 133
LIST OF TABLES
Table
No.Title
2009 and 2016
TNI Standard
Reference
ISO/IEC
17025:2005 (E)
Reference
ISO/IEC
17025:2017(E)
Reference
Page
No.
5-1 Analytical Staff Education and
Experience Requirements 29
5-2 Examples or Required Training 32
14-1 Example – General Corrective
Action Procedures
V1M2 Sec.
4.11.6.
V1M4 Sec.
1.7.4.1
4.11.2
65
16-1 Record Index 4.13.1.1 70
16-2 Example: Special Record Retention
Requirements 72
17-1 Types of Internal Audits and
Frequency
4.14.1 77
24-1 Example – Negative Controls 110
24-2 Examples of Negative Controls for
Microbiology 111
LIST OF FIGURES
Figure
No.Title
2009 and 2016
TNI Standard
Reference
ISO/IEC
17025:2005(E
) Reference
ISO/IEC
17025:2017(E
) Reference
Page
No.
4-1 Corporate and Laboratory
Organization Charts
V1M2 Sec. 4.1.5 4.1.3;
4.1.5; 4.2.6 26
23-2 Example: Sample Acceptance
Policy
V1M2 Sec. 5.8.6;
5.8.7.1V1M4 Sec.
1.7.5
109
LIST OF APPENDICES
Appendix
No.Title
Page
No.
1 List of Governing Documents applicable to the QA
Manual 123
2 Appendix 2 125
3 References used to prepare the QA Manual 125
4 Error: Reference source not found 126
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3.0 INTRODUCTION, SCOPE AND APPLICABILITY
3.1 Introduction and Compliance References
Eurofins EMLab P&K’s Quality Assurance (QA) Manual is a document prepared to define the
overall policies, organization objectives and functional responsibilities for achieving Eurofins
EMLab P&K’s data quality goals. Governing SOPs are in place within the organization to ensure
the proper execution of this QA Manual (refer to Appendix 1). This manual and referenced
documents are required reading for all personnel within t he Eurofins EMLab P&K network,
which is comprised of two legal entities, EMLab P&K, LLC and Aerotech Laboratories, Inc.
The laboratory is a team of people who work together to serve the health and environmental
needs of society through science and technology. The Eurofins EMLab P&K network of
laboratories maintains a local perspective in its scope of services and client relations and
maintains a national perspective in terms of quality.
The QA Manual has been prepared to assure compliance with The NELAC Institute (TNI)
Standard, dated 2009 and 2016; ISO/IEC Guide 17025:2005 and 2017. Policies and
procedures listed in Appendix 1 are compliant with the National Divisional Support Center
(NDSC) Quality Management Plan (QMP) for Eurofins TestAmerica; Eurofins EMLab P&K and
the various accreditation and certification programs which are held by the laboratory to support
environmental work (Appendix 2).
Refer to Appendix 3 for a list of additional references for which this QA Manual is compliant.
3.2 Terms and Definitions
A Quality Assurance Program is a company-wide system designed to ensure that data produced
by the laboratory conforms to the standards set by state and/or federal regulations (i.e. CA-
ELAP, TCEQ, NYS DOH, etc.), as well as applicable accrediting bodies. The program functions
at the local management level through company goals, from guidance at the executive
management level, and at the analytical level through Standard Operating Procedures (SOPs)
and quality control. Our program is designed to minimize systematic error, encourage
constructive, documented problem solving, and provide a framework for continuous
improvement within the organization.
Refer to Appendix 4 for the Glossary/Acronyms.
3.3 Scope / Fields of Testing
The laboratory analyzes a broad range of environmental and industrial samples. Sample matrices
vary, but are not limited to, air, potable and non-potable waters, bulks, wipes, swabs, dust, soils,
etc. The Quality Assurance Program contains specific procedures and methods to test samples of
differing matrices for chemical, physical and biological parameters. The Program also contains
guidelines on maintaining documentation of analytical processes, reviewing results, servicing
clients and tracking samples through the laboratory. The technical and service requirements of all
analytical requests are thoroughly evaluated before commitments are made to accept the work.
Measurements are made using published reference methods or methods developed and
validated by the laboratory.
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The methods covered by this manual include the most frequently requested methodologies
needed to provide analytical services in the United States and its territories. The specific list of
test methods used by the laboratory can be found in LabServe, under the services list.
Additional information, such as facility specific scopes of accreditation, may be found on the
Eurofins EMLab P&K, LLC website.
The approach of this manual is to define the minimum level of quality assurance and quality
control necessary to meet these requirements. All methods performed by the laboratory shall
meet these criteria as appropriate. In some instances, quality assurance project plans (QAPPs),
project specific data quality objectives (DQOs) or local regulations may require criteria other
than those contained in this manual. In these cases, the laboratory will abide by the requested
criteria following review and acceptance of the requirements by the Cluster Leader and the
Quality Assurance (QA) Manager. In some cases, QAPPs and DQOs may specify less stringent
requirements. The Cluster Leader and the QA Manager must determine if it is in the lab’s best
interest to follow the less stringent requirements.
3.4 Management of the Manual
3.4.1 Review Process
Eurofins National Divisional Support Center (NDSC) which houses the Quality Assurance
leadership team for Eurofins Environment Testing America. NDSC QA will assure that the
template remains in compliance with Section 3.1. This manual itself is reviewed annually by
Cluster Leaders and Quality Assurance Managers, to assure that it reflects current practices
and meets the requirements of the laboratory’s clients and regulators as well as the QMP.
Occasionally, the manual may need changes in order to meet new or changing regulations and
operations. The QA Manager will review the changes in the normal course of business and
incorporate changes into revised sections of the document. All updates will be reviewed by the
Cluster Leaders and Quality Assurance Managers. The laboratory updates and approves such
changes according to our Document Control & Updating procedures (refer to SOP No. EM-QA-
S-2059).
4.0 MANAGEMENT REQUIREMENTS
4.1 Overview
Eurofins EMLab P&K, LLC is a is a business unit of Eurofins Environment Testing America Built
Environment The laboratory’s operational and support staff have the day-to-day independent
operational authority under the direction of the Eurofins Built Environment Laboratory President,
Business Unit Manager, and Cluster Leaders and is supported by the NDSC QA team. The
laboratory operational and support staff work under the direction of the Cluster Leaders. The
organizational chart of the management staff are presented in Figure 4-1. Individual
departmental staff lists are maintained in the laboratory’s internal intranet.
4.2 Selection of Personnel
Where individual facility updates, changes or goals necessitate, hiring or transfer of personnel
either into new or existing roles is driven by cluster leaders. Once defined as a need, all aspects
of the hiring process at Eurofins EMLab P&K are managed via the Eurofins US Recruitment
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team. All position requests are submitted to the Eurofins US Recruitment team for coordination
and planning of position details (requirements, location, salary, etc.). The process includes the
review and setting of timelines, selection of posting sites, and defining recruitment team and
hiring manager responsibilities associated with the available position.
4.3 Roles and Responsibilities
In order for the Quality Assurance Program to function properly, all members of the staff must
clearly understand and meet their individual responsibilities as they relate to the quality
program. The responsibility for quality resides with every employee of the laboratory. All
employees have access to the QA Manual, are trained to this manual, and are responsible for
upholding the standards therein. Each person carries out his/her daily tasks impartially and in a
manner consistent with the goals and in accordance with the procedures in this manual and the
laboratory’s SOPs. The following descriptions briefly define each role in its relationship to the
Quality Assurance Program.
4.3.1 Vice President of Quality and Environmental Health and Safety (VP-QA/EHS)
The Vice President (VP) of QA/EHS reports directly to Eurofins Environment Testing America
Chief Operating Officer (COO). With the aid of the NDSC Quality Team Members, Business Unit
Managers, Laboratory Directors, the VP-QA/EHS has the responsibility for the establishment,
general overview and maintenance of the Quality Assurance and EH&S Programs within
Eurofins Environment Testing America. Additional responsibilities include:
Review of QA/QC and EHS aspects of NDSC Official Document, national projects and
expansions or changes in services.
Work with various organizations outside of the laboratory to further the development of
quality standards and represent the laboratory at various trade meetings.
Prepare monthly reports for quality and EH&S metrics across the environmental testing
laboratories and a summary of any quality and EH&S related initiatives and issues.
With the assistance of the Executive Management, and the EHS Managers, maintenance
and implementation of the Eurofins Environment Testing America Environmental, Health and
Safety Program.
4.3.2 Quality Directors
There are four (4) Quality Directors within NDSC that report directly to the VP-QA/EHS. These
Quality Directors have oversight of the general overview and maintenance of the QA Program
within the Eurofins Environment Testing America laboratories. Supported tasks include:
-Monitors laboratory internal audit findings;
-Identifies common laboratory weaknesses and monitors corrective action closures.
-Develops NDSC quality guidance documents and management tools for ensuring and
improving compliance;
-Monitors and communicates DoD/DoE requirements;
-Monitors and communicates regulatory and certification requirements;
-Training and OnBoarding
-Laboratory assessments, mentoring, and interventions
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-Track/drive root cause investigations and corrective action plans
-Builds knowledge base for preventive actions
4.3.3 Quality Information Manager
The Quality Information works directly with the NDSC Quality Directors and EHS Managers; and
reports directly to the VP-QA/EHS. The Quality Information Manager is responsible for the
management of:
-NDSC Official Documents
-TALS/LIMS Certification Module Data
-Company’s Intranet website
-Company’s Regulatory Limits Database
-Subcontract laboratory and approved vendor information
-Internal and External client support for various company groups (e.g., Client Services,
EH&S, Legal, IT, Sales) for both quality and operational functions
-Communicate regulatory information and lists
4.3.4 Environmental Health and Safety (EH&S) Managers
There are 3 EH&S Managers within NDSC that report directly to the VP-QA/EHS. These EH&S
Managers have oversight of the general overview and maintenance of the EH&S Program within
the Eurofins Environment Testing America laboratories. Supported tasks include:
Consolidation and tracking all safety and health-related information and reports for the
company, and managing compliance activities for Eurofins Environment Testing America
locations.
Coordination/preparation of the Environmental, Health and Safety Manual Template that is
used by each laboratory to prepare its own laboratory-specific Safety Manual/ CHP.
Preparation of information and training materials for laboratory EHS Coordinators.
Assistance in the coordination of employee exposure and medical monitoring programs to
insure compliance with applicable safety and health regulations.
Serving as Department of Transportation (D.O.T.) focal point and providing technical
assistance to location management.
Serving as Hazardous Waste Management main contact and providing technical assistance
to location management.
4.3.5 Ethics and Compliance Officers (ECOs)
The NDSC VP-QA/EHS and Corporate Counsel are designated Each ECO acts as a back-up to
the other ECO and both are involved when data investigations occur. Each ECO has a direct
line of communication to the entire executive management personnel and lab management
staff.
The ECOs monitor and audit procedures to determine compliance with policies and to make
recommendations for policy enhancements to the President, COO, Laboratory Director or other
appropriate individuals within the laboratory. The ECO will assist the laboratory QA Manager in
the coordination of internal auditing of ethical policy related activities and processes within the
laboratory, in conjunction with the laboratory’s regular internal auditing function.
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The ECOs will also participate in investigations of alleged violations of policies and work with
the appropriate internal departments to investigate misconduct, remedy the situation, and
prevent recurrence of any such activity.
4.3.6 Business Unit Manager
The Business Unit Manager is responsible for the overall quality, safety, financial, technical,
human resource and service performance of the network of Eurofins EMLab P&K laboratories
and reports to their business unit President. The Business Unit Manager provides the resources
necessary to implement and maintain an effective and comprehensive Quality Assurance and
Data Integrity Program. Provides support to the laboratory management of all clusters and is
responsible for the overall performance and viability of the lab’s profitability. The GM is also
responsible for generating positive operating margin and growing revenues for the company at
the business unit level by supporting business and market strategy plans. Responsibilities
include, but are not limited to:
Manages labs in accordance with business plan and analyzes financial performance to meet
the business objectives.
Monitors progress of business units toward objectives and key performance indicators
(KPI's) to improve financial performance, customer service and revenue growth daily.
Ensures that personnel are free from any commercial, financial and other undue pressures
which might adversely affect the quality of their work.
Provides weekly and monthly reports to management to ensure that goals and objectives
are being achieved and to recognize opportunities for development.
Conducts supervisory responsibilities with direct reports to foster and maintain strong staff
performance.
Prepares annual capital and operating budgets for business units yearly to meet financial
goals and objectives.
Responsible for establishing new business developments and additive growth to meet
financial objectives.
Facilitates local and company-wide initiatives and activities weekly to promote cooperation
and consistency across their group and the company.
Communicates with employees daily concerning objectives, company direction and
expectations to create a positive work environment and improve staff performance.
Supports all company policies and procedures daily to ensure compliance with standard
operating procedures (SOP's).
Meets with clients on a regular basis to evaluate lab performance and respond to changing
customer requirements
Reviews audit findings and ensures corrective actions are taken as needed to maintain
compliance.
Assists laboratory management personnel with operational issues including contract
negotiations, sales and service issues, customer relations, and key proposals in order to
ensure smooth operating systems and meet customer needs.
Participates in corporate and group lab meetings to support key Eurofins TestAmerica
initiatives and provide supervision at remote facilities.
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4.3.7 Cluster Leader
The Cluster Leaders are responsible for maintaining positive operating margin to the company
at the laboratory level and for meeting and exceeding the annual budget. The Cluster Leaders
are responsible for overseeing operations personnel of the Eurofins EMLab P&K, LLC
laboratories in their individual cluster, and providing guidance and direction as needed. Eurofins
EMLab P&K, LLC’s laboratories are grouped in clusters, as defined in organization charts,
Figure 4-1. These positions represent the analytical departments in corporate planning and
implementation of policies. This includes assuring the quality of all processes through training
and placement of departmental personnel in key roles and coordination of department activities
with other corporate departments and assuring the smooth flow of work on a daily basis. The
Cluster Leader directly or indirectly manages their client service personnel who are the contacts
for clients regarding analytical services and advice. The Cluster Leader will work closely with the
Business Unit Manager in monitoring, reviewing and directing laboratory personnel, including
through the individual Laboratory Managers and Supervisors. The Cluster Leaders are also
responsible for implementing the safety policies for their facilities. Responsibilities include but
are not limited to:
Overall responsibility for the operation of the analytical laboratories in their cluster
Coordinates and supervises all activities related to Eurofins EMLab P&K, LLC analytical
processes Manages the laboratory to provide positive operating margin for the company and
meet annual budgetary goals.
Approves of all laboratory purchases including capital spending approvals to support the
business plan and maintain profitability.
Ensures that all analysts and supervisors have the appropriate education and training to
properly carry out the duties assigned to them and ensures that this training has been
documented. Works with Eurofins Environment Testing Human Resources for hiring of new
personnel.
Ensures that personnel are free from any commercial, financial and other undue pressures
which might adversely affect the quality of their work.
Ensures company human resource policies are adhered to and maintained.
Ensures that sufficient numbers of qualified personnel are employed to supervise and
perform the work of the laboratory. Assesses laboratory capacity and workload.
Ensures that appropriate corrective actions are taken to address analyses identified as
requiring such actions by internal and external performance or procedural audits.
Communicates facility specific goals and objectives to employees.
Reviews and approves all SOPs prior to their implementation and ensures all approved
SOPs are implemented and adhered to.
Pursues and maintains appropriate laboratory certification and contract approvals. Supports
ISO 17025 requirements.
Maintains positive customer relationships through direct interaction with customers, as
needed.
Ensures client specific reporting and quality control requirements are met.
Contributes to the continuous improvement of the laboratory operations.
Maintains an awareness of technical developments and regulatory requirements.
Represents analytical services in corporate planning and vision
Develops new and alternate analytical services
Performs periodic reviews of their direct staff and oversees evaluation of analyst and/or
laboratory technician performance and provides written feedback regarding performance
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Reviews analytical methods on an biennial basis
Ensures that the EHS program is enforced and the EHS Manual is implemented in the
facilities under their control
Can act as a Technical Manager or NVLAP Approved Signatory if approved by respective
regulatory agency.
This individual may serve as report signatory.
Departmental Relations
Reports directly to the Business Unit Manager.
Works directly with the Quality Assurance Manager to ensure accuracy and precision of all
analytical results
Works with Facility Managers and personnel to coordinate implementation of company
policies
Qualifications (Minimum)
An earned life science degree, minimally at the baccalaureate level and a minimum of two
years of full time equivalent documented relevant environmental microbiological work
experience (mycological and/or bacteriological) and/or an earned physical or biological
science degree, minimally at the baccalaureate level.
The individual must be familiar with indoor air quality, bacteriological sampling and analytical
methodology.
4.3.8 Senior Quality Assurance (QA) Manager
The Senior Quality Assurance (QA) Manager, in addition to all the responsibilities of a QA Manager
(Section 4.2.4), is also responsible for managing the QA Managers or Quality Coordinators of
assigned laboratories. The Senior QA Manager oversees the assigned laboratories to ensure that
these labs have implemented an effective quality management system and that the labs drive
continuous improvement. This includes identifying or developing quality management tools and
training quality staff in the implementation of quality management systems, techniques and
tools. The Senior QA Manager reports directly to the General Manager. In addition to those
responsibilities listed in Section 4.2.4, responsibilities of the Senior QA Manager include, but are
not limited to:
Act as the QA representative and a representative of senior management in client
meetings, regulatory meetings, open forums for discussing regulation changes, etc.
Generate and submit monthly QA reports for the Management team to keep the team
informed of the QA activities
Provide the necessary support to drive and lead the initiative in making improvements
to different processes/functions/procedures within the Quality Assurance program by
closely working with other QA Managers, Operations, IT and the Management team
Assist Business Unit Manager in QA personnel decisions including: staffing, hiring,
evaluations, and disciplinary actions as requested.
Supervise and coordinate the activities of the QA staff at assigned laboratories. Serve as a
resource to all laboratory personnel on QA issues.
Captains the QA team to enable communication and to distribute duties and
responsibilities.
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4.3.9 Quality Assurance (QA) Manager
The QA Manager has responsibility and authority to ensure the continuous implementation of
the quality system. The QA Manager reports directly to the Senior Quality Assurance Manager.
This position is able to evaluate data objectively and perform assessments without outside (e.g.,
managerial) influence. The NDSC Team may be used as a resource in dealing with regulatory
requirements, certifications and other quality assurance related items. The Senior QA Manager
directs the activities of the QA Managers to accomplish specific responsibilities, which include,
but are not limited to:
Serves as the focal point for QA/QC in the laboratory.
Have functions independent from laboratory operations for which he/she has quality
assurance oversight.
Have documented training and/or experience in QA/QC procedures and the laboratory’s
Quality System.
Arrange for or conducting internal audits on quality systems and the technical operation
Implements and oversees the Eurofins EMLab P&K, LLC Quality Assurance program for the
main laboratories and satellite laboratories (microlabs).
Maintains and updates the Quality Assurance Manual.
Maintains all quality control statistical data and other quality control documentation.
Annually audits the Quality Assurance program, reporting procedures, and other
documentation for each assigned facility.
Works with supervisors to review, develop, and implement appropriate QA steps throughout
process flow to ensure high quality of work and reasonable documentation.
Assesses and implements requirements for current ISO/IEC 17025:2017, AIHA-LAP, LLC
EMLAP, IHLAP, and NVLAP accreditation, along with any other accreditations, such as state
specific accreditations/certifications (i.e. CA-ELAP, NY-ELAP, etc.).
Responsible for ensuring that the laboratory is compliant to the current ISO/IEC 17025
standard, the AIHA-LAP, LLC, the NVLAP accreditation policies, and additional
accreditations as they apply.
Produces the monthly quality assurance report
Responsible for training in Quality Assurance department.
Maintains and controls all Quality Assurance documents and records.
Researches and obtains new accreditations/licensing as required.
Maintains regional facility accreditations/licensing and proficiency testing programs.
Notifying laboratory management of non-conformances in the quality system and ensuring
corrective action is taken. Procedures that do not meet the standards set forth in the QAM or
laboratory SOPs shall be investigated following procedures outlined in Section 12 and if
deemed necessary may be temporarily suspended during the investigation.
Communication to the relevant regulatory authorities when there are management or facility
changes that impact the laboratory.
Monitoring and evaluating laboratory accreditations, certifications, and licenses; scheduling
proficiency testing samples, where applicable.
Monitoring and communicating regulatory changes that may affect the laboratory to
management.
Training and advising the laboratory staff on quality assurance/quality control procedures
that are pertinent to their daily activities.
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The laboratory QA Manager will maintain records of all ethics-related training, including the
type and proof of attendance.
Maintain, improve, and evaluate the corrective action database and the corrective and
preventive action systems.
Objectively monitor standards of performance in quality control and quality assurance
without outside (e.g., managerial) influence.
Ensuring Communication & monitoring standards of performance to ensure that systems are
in place to produce the level of quality as defined in this document.
Evaluation of the thoroughness and effectiveness of training.
Qualifications (Minimum)
A baccalaureate degree in an applicable basic or applied science and have at least one year
of non-academic analytical experience.
Quality Assurance Manager shall have documented training in statistics or laboratory quality
assurance/quality control.
Have documented training and/or experience in QA/QC procedures and the laboratory’s
Quality System.
Have a general knowledge of the analytical test methods for which data audit/review is
performed (and/or having the means of getting this information when needed).
4.3.10 Quality Assurance (QA) Assistant / Environmental Health and Safety Coordinator
The combined role of Quality Assurance Assistant / Environmental Health and Safety
Coordinator holds dual responsibilities within the Quality Assurance team and the EH&S
program for Eurofins EMLab P&K and reports directly to the Senior Quality Assurance Manager.
The role of Quality Assurance Assistant includes assisting Quality Assurance Managers in the
maintenance and continual improvement of the Quality Management System for the
environmental microbiology, asbestos, lead, and radon programs. The role of Environmental
Health and Safety Coordinator (EHSC) is responsible for administering the EH&S program
across all Eurofins EMLab P&K locations, and working with facility management and local safety
committee teams to provide a safe, healthy working environment and maintain regulatory
compliance with local, state, and federal laws. The EH&S Coordinator role enforces
environmental, health, and safety policies and procedures. Responsibilities include, but are not
limited to:
QA Assistant Role:
Assist QA Managers with data entry and QC reporting
Assisting QA Managers with document control, including tracking and assignment of reviews
Assisting QA Managers in maintaining the laboratory’s reference data, preparation of
certification applications
Assisting with maintenance of training records for all employees
Assist with maintenance of technical records including SOPs, QC records, laboratory data,
etc.
Performs additional tasks as needed and directed by Quality Assurance Manager.
May perform customer service requests for Project Management staff, supply SOP's,
certification information, etc.
EHS Coordinator Role:
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Works with facility management and local safety committee members to ensure facility
compliance with the EH&S Manual and applicable policies/procedures.
Works with laboratory management and corporate EH&S to ensure all Eurofins EMLab P&K
facilities are monitored for unsafe conditions, acts, and potential hazards, proper personal
protective equipment is available and used, and personnel are properly trained in its use.
Completes monthly and annual EH&S reports, both internal and external.
Investigates accidents, incidents, and near misses and identifies root causes, and works with
management to eliminate those root causes. Completes accident investigation and reporting
in reporting suite.
Works with facility management to ensure that routine facility inspections for compliance with
health, safety and environmental regulations and procedures are completed at each facility.
Works with facility management to ensure that safety equipment checks are completed at
each location to ensure proper working order and sufficient inventory.
Plans, delivers and tracks completion of monthly refresher and general awareness training
sessions and compliance training, including new employee EH&S orientation.
Participates in and conducts routine EH&S committee meetings.
Conducts annual EH&S audits for Eurofins EMLab P&K
Qualifications (Minimum)
A high school diploma or GED and documented on-the-job experience training and
experience in general laboratory quality assurance/quality control.
4.3.11 Laboratory Manager
The Laboratory Manager, where applicable, is responsible for overseeing facility specific
analytical operations. The Facility Manager will work closely with the Cluster Leader in
monitoring, reviewing and directing laboratory work, analytical quality, and overall capacity
evaluations. Responsibilities include, but are not limited to:
Overall responsibility for the operation of the analytical laboratory
Coordinates and supervises all activities related to Eurofins EMLab P&K, LLC analytical
processes
Implements any Corrective Actions in the laboratory regarding analytical procedures or
processes.
Oversees training programs, if applicable
Provides assistance with Quality Assurance SOPs for the facility – through the Cluster
Leader – and ensures their implementation so that the facility is operated in a compliant
manner that allows it to produce defensible data.
Responsible for ensuring that the laboratory is compliant to the current ISO/IEC 17025
standard, the AIHA-LAP, LLC accreditation policies, the NVLAP accreditation policies, and
additional accreditations as they apply.
Interfaces with analysts to assure that quality analytical data is provided to clients and on –
time delivery dates are met.
Ensures that the employee health and safety procedures are implemented and followed to
maintain facility operations that are compliant with appropriate policies and regulations.
Maintains positive customer relationships through direct interaction with customers, as
needed.
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Ensures client specific reporting and quality control requirements are met.
Can act as the Technical Manager or NVLAP Approved Signatory if approved by respective
regulatory agency.
This individual may serve as report signatory.
Departmental Relations
Reports directly to the Cluster Leader.
Works directly with the Quality Assurance Manager to ensure accuracy and precision of all
analytical results.
Works with Cluster Leaders to coordinate implementation of company policies.
Works with facility personnel staff to implement company policies.
Qualifications (Minimum)
An earned life science degree, minimally at the baccalaureate level and a minimum of two
years of full time equivalent documented relevant environmental microbiological work
experience (mycological and/or bacteriological) and/or an earned physical or biological
science degree, minimally at the baccalaureate level.
The individual must be familiar with indoor air quality, bacteriological sampling and analytical
methodology.
4.3.12 Technical Manager or Designee
Technical Manager Qualifications
An earned science degree, minimally at the baccalaureate level, with a minimum of one year
of relevant laboratory experience, three months of which must be full time equivalent
documented environmental work experience applicable to analyses performed (i.e.
mycological and/or bacteriological microbiology, asbestos fibers by PCM, lead analyses).
The individual must be experienced in the selection and use of bioaerosol, surface, fluid and
raw material sampling methods and in sample processing for the quantification and
identification of mesophilic and thermophilic bacteria, and mesophilic, xerophilic, hydrophilic
and thermotolerant fungi (molds and yeasts) isolated by those methods, as applicable.
The individual must be experienced in the sampling methods and sample processing for the
quantification of asbestos and other fibers by PCM analysis, as applicable.
The individual must be experienced in the sampling methods and sample processing for the
quantification of lead, as applicable to AIHA-LAP, LLC ELLAP.
The technical manager or their designee shall be responsible for all technical operations and
shall be available to address technical issues for laboratory staff and customers concerning
analyses, as applicable.
This individual may serve as report signatory.
The individual must be present on-site at least 20 hours per week, or 50% of the laboratory
working hours (whichever is greater) to address technical issues for laboratory staff and
clients.
4.3.13 Senior Analyst
Senior analysts may oversee other departmental analyses, such as mycology and/or
bacteriology. Senior Analysts will provide leadership to analytical and support staff. A Senior
Analyst is responsible for providing high quality analyses and excellent client service. Senior
analysts may also oversee asbestos, allergen and other analytical testing done in the laboratory.
Responsibilities may include, but are not limited to:
May supervise and coordinate laboratory work flow and analyses
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Performs analysis
May train new analysts
Maintains client relations and technical support when applicable
Assists in research and development of new analytical services as required
Assists the QA manager in development, implementation and data collection of QA
processes for analytical services
Performs independent data reviews for other analyst's work
Departmental Relations
Reports to the Cluster Leader or Facility Manager.
Implements and performs mycological, bacteriological, asbestos and other analytical training
as required by the Cluster Leader
Supports other Supervisors, Facility Managers or Cluster Leader when necessary
Can act as the facility Technical Manager or NVLAP Approved Signatory if approved by
respective regulatory agency.
Qualifications (Minimum)
Environmental Microbiology Laboratory Program (Fungi and Bacteria)
An earned science degree, minimally at the baccalaureate level and a minimum of three
years of full time equivalent documented environmental microbiological work experience
(mycological and/or bacteriological).
Industrial Hygiene Laboratory Accreditation Program (PCM Asbestos)
An earned physical or biological science degree, minimally at the baccalaureate level and a
minimum of three years relevant nonacademic analytical chemistry experience. A minimum
of two years’ experience must be in asbestos analyses. The remaining one year can be
substituted for work experience.
Completion of NIOSH 582 (or equivalent) training course for PCM analyses.
National Voluntary Laboratory Accreditation Program (PLM Asbestos)
Understand polarized light microscopy and its application to crystalline materials sufficiently
to conduct analyses. That they understand what the various optical properties are, how they
are measured or observed in the microscope, and how the data are used to form a
conclusion about the identity of the component, (e.g., an analyst using central and/or
annular focal screening (dispersion staining) to measure refractive index must be able to
explain what produces the observed color and how that color is used to determine refractive
index) Analysts are competent with the polarized light microscope, Can properly align the
microscope and identify all of the crucial parts.
Completion of McCrone (or equivalent) training course for PLM analyses if deemed
necessary.
4.3.14 Analyst
Analysts perform a range of analyses based upon specific area of responsibility, including but
not limited to, aerobiological, environmental, asbestos and drinking water samples. Analysts are
responsible for high quality analyses and excellent client service. Responsibilities may include,
but are not limited to:
Analyzes samples for fungal and/or bacterial parameters
Identify macrofungi and microfungi
Analyzes samples for bacterial parameters, including drinking waters for coliforms and E.
coli
Process and prepare samples for analysis Analyze samples for asbestos
Analyze samples for allergens
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Digest and analyze samples for lead analysis.
Accurately records and reports analytical data
Performs specific tasks related to Quality Control
Maintains analytical quality control records
Performs regular analysis of reference materials and other quality control samples
Performs independent data reviews for other analysts’ work
Departmental Relations
Reports to Cluster Leader, or Facility Manager.
Works with management and support staff for optimal teamwork
Works with project management staff to clarify technical matters.
Can act as the facility Technical Manager and NVLAP Approved Signatory if approved by
respective regulatory agency
Qualifications (Minimum)
Environmental Microbiology Laboratory Program (Fungi and Bacteria)
A bachelor's degree in physical or biological science and documented on-the-job training as
an analyst trainee under the supervision of a Senior Analyst.
Industrial Hygiene Laboratory Accreditation Program (Asbestos)
A bachelor's degree in a physical or biological science, and a minimum of one year relevant
nonacademic analytical chemistry experience.
Completion of training courses for PCM analyses.
Environmental Lead Laboratory Accreditation Program (ELLAP)
A bachelor's degree in physical or biological science and one month of documented on-the-
job training as an analyst trainee under the supervision of a Senior Analyst.
National Voluntary Laboratory Accreditation Program (PLM Asbestos)
Understand polarized light microscopy and its application to crystalline materials sufficiently
to conduct analyses. That they understand what the various optical properties are, how they
are measured or observed in the microscope, and how the data are used to form a
conclusion about the identity of the component, (e.g., an analyst using central and/or
annular focal screening (dispersion staining) to measure refractive index must be able to
explain what produces the observed color and how that color is used to determine refractive
index). Analysts are competent with the polarized light microscope, and can properly align
the microscope and identify all of the crucial parts.
Completion of McCrone (or equivalent) training course for PLM analyses if deemed
necessary.
4.3.15 Laboratory Technician/Assistant
Laboratory technicians and assistants prepare bioaerosol and microbial samples for fungal and
bacteriological analysis. Receive samples and complete required paperwork for processing and
analysis of samples, where applicable. Responsibilities may include, but are not limited to:
Prepares bioaerosol and microbial samples for fungal and bacterial analysis
Cultures fungi and bacteria from environmental samples for analysis
Works with a variety of sampling media for optimal results
Analyzes samples for fungal parameters
Identify macrofungi and microfungi
Analyzes samples for bacterial parameters, including drinking waters for coliforms and E.
coli
Analyze water samples for analysis
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Analyze samples for asbestos
Analyze samples for allergens
Digest and analyze samples for lead analysis.
Accurately enters and reports analytical data
Performs specific tasks related to Quality Control
Performs required Quality Control procedures
Maintenance of laboratory supplies, equipment, and routine lab reagents
Prepare samples for ELISA analysis and perform ELISA analysis
Departmental Relations
Reports to Cluster Leader or Facility manager
Work with analysts to complete samples by required deadlines
Work with log-in and receiving supervisors to control flow of work through the laboratory.
Can act as the NVLAP Approved Signatory if approved by respective regulatory agency.
Qualifications (Minimum)
Environmental Microbiology Laboratory Program (Fungi and Bacteria)
A high school diploma or GED and documented on-the-job training as an analyst trainee
under the supervision of a Senior Analyst.
Environmental Lead Laboratory Accreditation Program (ELLAP)
A high school diploma or GED and documented on-the-job training as an analyst trainee
under the supervision of a Senior Analyst.
National Voluntary Laboratory Accreditation Program (PLM Asbestos)
Understand polarized light microscopy and its application to crystalline materials sufficiently
to conduct analyses. That they understand what the various optical properties are, how they
are measured or observed in the microscope, and how the data are used to form a
conclusion about the identity of the component, (e.g., an analyst using central and/or
annular focal screening (dispersion staining) to measure refractive index must be able to
explain what produces the observed color and how that color is used to determine refractive
index); b) analysts are competent with the polarized light microscope, Can properly align the
microscope and identify all of the crucial parts.
Completion of McCrone (or equivalent) training course for PLM analyses if deemed
necessary.
4.3.16 Project Manager (PM)
Members of the laboratory Client Services/Project Management Group are responsible for
organizing and managing client projects. Clients are assigned a project manager who serves as
their primary contact at the laboratory. It is the PM’s responsibility to act as the client advocate
by communicating client requirements to laboratory personnel and ensuring that clients provide
complete information needed by the laboratory to meet those requirements – including all verbal
communications. The PM reports to the Cluster Leader and serves as the interface between the
laboratory’s technical departments and the laboratory’s clients. With the overall goal of total
client satisfaction, the functions of this position are outlined below:
Scheduling sample submissions, sample container orders and sample pick-up via the
laboratory courier service.
Confirming certification status
Coordinating and communicating turnaround time (TAT) requirements for high priority
samples/projects.
Answering common technical questions, facilitating problem resolution and coordinating
technical details with the laboratory staff.
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Responsible to ensure that clients receive the proper sampling supplies.
Accountable for response to client inquiries concerning sample status.
Responsible for assistance to clients regarding the resolution of problems concerning COC.
Ensuring that client specifications, when known, are met by communicating project and
quality assurance requirements to the laboratory.
Notifying the supervisors of incoming projects and sample delivery schedules.
Responsible for discussing with client any project-related problems, resolving service issues,
and coordinating technical details with the laboratory staff.
Responsible for staff familiarization with specific quotes, sample log-in review, and final
report completeness.
Monitor the status of all data projects in-house to ensure timely and accurate delivery of
reports.
Inform clients of data project-related problems and resolve service issues.
Coordinate requests for sample containers and other services (data packages).
4.4 Business Continuity and Contingency Plans
Various policies and practices are in place to address continuity of business and contingency
plans to ensure continued operations or minimal disruption in operations should unplanned
events (natural disasters, unexpected management changes, etc.) occur. Deputies are identified
for all key management personnel. Deputies would temporarily fill a role if the primary is absent
for more than 15 consecutive calendar days. The deputies must meet the same qualifications as
the primary person should they be required to take on the responsibilities. The QA Manager
communicates to the relevant regulatory authorities when there are management or facility
changes that impact the laboratory. Changes in the technical director must be communicated
within a period of time and in the manner dictated by each regulatory authority.
The Eurofins EMLab P&K Deputy List, document EM-QA-R-7794, defines who assumes the
responsibilities of key personnel in their absence for the western region and the eastern region
respectively.
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Figure 4-1.Corporate and Laboratory Organization Charts
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5.0 PERSONNEL
5.1 Overview
The laboratory’s management believes that its highly qualified and professional staff is the
single most important aspect in assuring a high level of data quality and service. The staff
consists of professionals and support personnel.
All personnel must demonstrate competence in the areas where they have responsibility. Any
staff that is undergoing training shall have appropriate supervision until they have demonstrated
their ability to perform their job function on their own. Staff shall be qualified for their tasks
based on appropriate education, training, experience and/or demonstrated skills as required.
The laboratory employs sufficient personnel with the necessary education, training, technical
knowledge and experience for their assigned responsibilities. Personnel may perform
laboratory activities in more than one facility as directed by Cluster Leaders. Authorized analysts
may be employed across more than one facility as needed to meet operational and personnel
needs, Where personnel are deployed to a secondary facility, records are to be maintained
detailing the dual facility assignments, anticipated timeframe of assignment, and organizational
charts must reflect the use of dual location analysts where long term arrangements are in place
(greater than 15 business days).
All personnel are responsible for complying with all QA/QC requirements that pertain to the
laboratory and their area of responsibility. Each staff member must have a combination of
experience and education to adequately demonstrate a specific knowledge of their particular
area of responsibility. Technical staff must also have a general knowledge of lab operations,
test methods, QA/QC procedures and records management.
Laboratory management is responsible for formulating goals for lab staff with respect to
education, training and skills and ensuring that the laboratory has a policy and procedures for
identifying training needs and providing training of personnel. The training shall be relevant to
the present and anticipated responsibilities of the lab staff.
The laboratory only uses personnel that are employed by or under contract to, the laboratory.
Contracted personnel, when used, must meet competency standards of the laboratory and work
in accordance to the laboratory’s quality system.
5.2 Education and Experience Requirements for Technical Personnel
The laboratory makes every effort to hire analytical staffs that possess a college degree (AA,
BA, BS) in an applied science with some biology in the curriculum. Exceptions can be made
based upon the individual’s experience and ability to learn. Selection of qualified candidates for
laboratory employment begins with documentation of minimum education, training, and experience
prerequisites needed to perform the prescribed task. Minimum education and training
requirements for laboratory employees are outlined in job descriptions maintained by Eurofins
Environment Testing America Human Resources.
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Experience and specialized training are occasionally accepted in lieu of a college degree (basic
lab skills such as using a balance, colony counting, aseptic or quantitation techniques, etc., are
also considered).
As a general rule for analytical staff, refer to Table 5-1:
Table 5-1. Analytical Staff Education and Experience Requirements

Specialty Education Experience
Sample Processing H.S. Diploma or GED On the job training (OJT)
Laboratory Technician /
Assistant
H.S. Diploma or GED One year of documented on-
the-job training as an analyst
trainee under the supervision of
a Senior Analyst.
For fungal air direct exam
(spore trap) and/or lead,
analysts are required to
undergo six months of
documented on-the-job training
as a spore trap analyst trainee
under the supervision of a
Senior Analyst.
Laboratory Technician /
Assistant (PLM
Asbestos)
H.S. Diploma or GED
Completion of McCrone (or equivalent)
training course for PLM analysis if
deemed necessary.
Understand polarized light
microscopy and its application
to crystalline materials
sufficiently to conduct analyses.
That they understand what the
various optical properties are,
how they are measured or
observed in the microscope,
and how the data are used to
form a conclusion about the
identity of the component, (e.g.,
an analyst using central and/or
annular focal screening
(dispersion staining) to
measure refractive index must
be able to explain what
produces the observed color
and how that color is used to
determine refractive index).
Analysts are competent with the
polarized light microscope, and
can properly align the
microscope and identify all of
the crucial parts. Completion of
McCrone (or equivalent)
training course for PLM
analysis if deemed necessary.
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Specialty Education Experience
Senior Analyst –
Mycology/Bacteriology
An earned science degree, minimally at
the baccalaureate level.
Minimum of three years of full
time equivalent documented
environmental microbiological
work experience (mycological
or bacteriological)
Senior Analyst – PCM
Asbestos
An earned physical or biological science
degree, minimally at the baccalaureate.
Level. Completion of NIOSH 582 (or
equivalent) training course for PCM
analyses.
A minimum of three years
relevant nonacademic
analytical chemistry experience.
A minimum of two years’
experience must be in asbestos
analyses. The remaining one
year can be substituted for work
experience.
Senior Analyst – PLM
Asbestos
A bachelor's degree in physical or
biological science.
Completion of McCrone (or equivalent)
training course for PLM analysis if
deemed necessary.
Understand polarized light
microscopy and its application
to crystalline materials
sufficiently to conduct analyses.
That they understand what the
various optical properties are,
how they are measured or
observed in the microscope,
and how the data are used to
form a conclusion about the
identity of the component, (e.g.,
an analyst using central and/or
annular focal screening
(dispersion staining) to
measure refractive index must
be able to explain what
produces the observed color
and how that color is used to
determine refractive index)
Analysts are competent with the
polarized light microscope.
Can properly align the
microscope and identify all
crucial parts.
Analyst
(Fungi/Bacteria)
A bachelor's degree in physical or
biological science.
Six months of documented on-
the-job training as an analyst
trainee under the supervision of
a Senior Analyst (For fungal air
direct exam (spore trap),
analysts are required to
undergo three months of
documented on-the-job training
as a spore trap analyst trainee
under the supervision of a
Senior Analyst.)
Analyst (PCM
Asbestos)
A bachelor's degree in a physical or
biological science. Completion of
training course for PCM analysis.
A minimum of one year relevant
nonacademic analytical
chemistry experience.
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Specialty Education Experience
Analyst (PLM
Asbestos)
A bachelor's degree in physical or
biological science.
Completion of McCrone (or equivalent)
training course for PLM analysis if
deemed necessary.
Understand polarized light
microscopy and its application
to crystalline materials
sufficiently to conduct analyses.
That they understand what the
various optical properties are,
how they are measured or
observed in the microscope,
and how the data are used to
form a conclusion about the
identity of the component, (e.g.,
an analyst using central and/or
annular focal screening
(dispersion staining) to
measure refractive index must
be able to explain what
produces the observed color
and how that color is used to
determine refractive index).
Analysts are competent with the
polarized light microscope, and
can properly align the
microscope and identify all of
the crucial parts.
Analyst (Lead)A bachelor's degree in physical or
biological science.
One month of documented on-
the-job training as an analyst
trainee under the supervision of
a Senior Analyst.
Technical Managers An earned science degree, minimally at
the baccalaureate level.
(For bacteria/fungi: The individual must
be experienced in the selection and use
of bioaerosol, surface, fluid and raw
material sampling methods and in
sample processing for the quantification
and identification of mesophilic and
thermophilic bacteria, and mesophilic,
xerophilic, hydrophilic and
thermotolerant fungi (molds and yeasts)
isolated by those methods.)
A minimum of one year of
relevant laboratory experience,
three months of which must be
full time equivalent documented
environmental microbiological
work experience (mycological
and/or bacteriological).
When an analyst does not meet these requirements, they can perform a task under the direct
supervision of a qualified analyst, peer reviewer or Technical Manager, and are considered an
analyst in training. The person supervising an analyst in training is accountable for the quality of
the analytical data and must review and approve data and associated corrective actions.
5.3 Training
The laboratory is committed to furthering the professional and technical development of
employees at all levels.
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Orientation to the laboratory’s policies and procedures, in-house method training, and employee
attendance at outside training courses and conferences all contribute toward employee proficiency.
Below are examples of various areas of required employee training:
Table 5-2. Examples of Required Training
Required Training Time Frame Employee Type
Environmental Health & Safety Prior to lab work All
Ethics – New Hires 1 week of hire All
Ethics – Comprehensive 60 days of hire All
Data Integrity 60 days of hire Technical and PMs
Quality Assurance 90 days of hire All
Ethics – Comprehensive Refresher Annually All
Initial Demonstration of Capability
(DOC)
Prior to unsupervised
method performance
Technical
The laboratory maintains records of relevant authorization/competence, education, professional
qualifications, training, skills and experience of technical personnel (including contracted
personnel) as well as the date that approval/authorization was given. These records are kept
on file at the laboratory. Authorizations are applicable across the Eurofins EMLab P&K network
of laboratories for shared procedures. Also refer to “Demonstration of Capability” in Section 19.
The training of technical staff is kept up to date by:
Each employee must have documentation in their training file that they have read,
understood and agreed to follow the most recent version of the laboratory QA Manual and
SOPs in their area of responsibility. This documentation is updated as SOPs are updated.
Documentation from any training courses or workshops on specific equipment, analytical
techniques or other relevant topics.
Documentation of proficiency (refer to Section 19).
An Ethics Agreement signed by each staff member (renewed each year) and evidence of
annual ethics training.
A Confidentiality Agreement signed by each staff member signed at the time of employment.
Human Resources maintains documentation and attestation forms on employment status
and records; benefit programs; timekeeping/payroll; and employee conduct (e.g., ethics
violations). This information is maintained in the employee’s secured personnel file.
Evidence of successful training could include such items as:
Adequate documentation of training within operational areas, including one-on-one technical
training for individual technologies, and particularly for people cross-trained.
Analysts knowledge to refer to QA Manual for quality issues.
Analysts following SOPs, i.e., practice matches SOPs.
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Analysts regularly communicate to supervisors and QA if SOPs need revision, rather than
waiting for auditors to find problems.
Further details of the, laboratory's training program are described in the Laboratory Training SOP
(EM-AD-S-1646, General Training).
5.4 Data Integrity and Ethics Training Program
The laboratory’s Ethics and Data Integrity Program is discussed in Section 7.2. Employees are
trained as to the legal and environmental repercussions that result from data misrepresentation.
Key topics covered in the presentation include:
Organizational mission and its relationship to the critical need for honesty and full disclosure
in all analytical reporting.
Ethics Policy
How and when to report ethical/data integrity issues. Confidential reporting.
Record keeping.
Discussion regarding data integrity procedures.
Specific examples of breaches of ethical behavior (e.g. peak shaving, altering data or
computer clocks, improper macros, etc., accepting/offering kickbacks, illegal accounting
practices, unfair competition/collusion)
Internal monitoring. Investigations and data recalls.
Consequences for infractions including potential for immediate termination, debarment, or
criminal prosecution.
Importance of proper written narration / data qualification by the analyst and project
manager with respect to those cases where the data may still be usable but are in one
sense or another partially deficient.
Additionally, a data integrity hotline [phone]) is maintained by The NDSC.
6.0 ACCOMMODATIONS AND ENVIRONMENTAL CONDITIONS
6.1 Overview
Each Eurofins EMLab P&K laboratory is a secure laboratory facility with controlled access and
designed to accommodate an efficient workflow and to provide a safe and comfortable work
environment for employees. All visitors sign in and are escorted by laboratory personnel. Access
is controlled by various measures.

Each laboratory is equipped with structural safety features. Each employee is familiar with the
location, use, and capabilities of general and specialized safety features associated with their
workplace. The laboratory provides and requires the use of protective equipment including
safety glasses, protective clothing, gloves, etc., OSHA and other regulatory agency guidelines
regarding required amounts of bench and fume hood space, lighting, ventilation (temperature
and humidity controlled), access, and safety equipment are met or exceeded.
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Traffic flow through sample preparation and analysis areas is minimized to reduce the likelihood
of contamination. Adequate floor space and bench top area is provided to allow unencumbered
sample preparation and analysis space. Sufficient space is also provided for storage of reagents
and media, glassware, and portable equipment. Ample space is also provided for refrigerated
sample storage before analysis and archival storage of samples after analysis. Laboratory
HVAC and deionized water systems are designed to minimize potential trace contaminants.
The laboratory is separated into specific areas for sample receiving, sample preparation,
microbiological sample analysis, asbestos sample analysis, lead sample analysis, and
administrative functions.
6.2 Environment
Laboratory accommodation, test areas, energy sources, and lighting are adequate to facilitate
proper performance of tests. Each facility is equipped with heating, ventilation, and air
conditioning (HVAC) systems appropriate to the needs of environmental testing performed at
this laboratory. The environment in which these activities are undertaken does not invalidate the
results or adversely affect the required accuracy of any measurements.
Each laboratory provides for the effective monitoring, control and recording of environmental
conditions that may affect the results of environmental tests as required by the relevant
specifications, methods, and procedures. Such environmental conditions include temperature of
in use equipment and within the laboratory, where applicable. Monitoring also includes
environmental monitoring for airborne molds, bacterial contaminants, surface lead and total
airborne fibers, including asbestos, which is performed on a predetermined schedule per facility.
When any of the method or regulatory required environmental conditions change to a point
where they may adversely affect test results, analytical testing will be discontinued until the
environmental conditions are returned to the required levels.
Environmental conditions of the facility housing the computer network and Labserve are
regulated to protect against raw data loss.
When the laboratory performs laboratory activities at sites or facilities outside its permanent
control, it shall ensure that the requirements related to facilities and environmental conditions of
this document are met.
Specific requirements for facility and environmental conditions, as well as periodic monitoring of
conditions, are given in the Environmental Health & Safety Manual plus each laboratory’s
Facility Addendum. Procedures and requirements for routine environmental monitoring are
found in EM-HS-S-1585.
6.3 Work Areas
There is effective separation between neighboring areas when the activities therein are
incompatible with each other. Examples include:
Microbiological culture handling and sample incubation areas.
Asbestos sample handling and preparation of reagents.
Chemical handling areas, including reagent preparation and waste disposal areas.
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Access to and use of all areas affecting the quality of analytical testing is defined and controlled
by secure access to the laboratory building as described below in the Building Security section.
Adequate measures are taken to ensure good housekeeping in each laboratory and to ensure
that any contamination does not adversely affect data quality. These measures include regular
cleaning to control dirt and dust within the laboratory . Work areas are available to ensure an
unencumbered work area. Work areas include:
Access and entryways to the laboratory.
Sample receipt areas.
Sample storage areas.
Chemical and waste storage areas.
Data handling and storage areas.
Sample processing areas.
Sample analysis areas.
Refer to the following documents and procedures for specific requirements for microbiological
laboratory facility requirements.
Standard Methods, 20th Ed., 9020B, Sec. 2
TNI V1M5, 1.7.3.7.a
CW-E-M-001, Eurofins TestAmerica Environmental Health and Safety Manual, Section 16
EM-HS-S-1639, Housekeeping and Decontamination
EM-HS-S-1286, Procedure for the Retention and Disposal of Samples
6.4 Responding to Emergencies
Employees must be aware of procedures to respond to all emergencies that might occur in the
workplace. Employees must be familiar with the location and proper operation of all emergency
equipment, evacuation routes and designated assembly areas for all areas where they work.
Refer to the NDSC EH&S Manual Document No. CW-E-M-001. Sec. 7 and the laboratory’s local
EH&S addendum for complete details. These documents provide direction for situations where
normal operations of the laboratory are not possible (e.g., electrical failures, heating/air
conditioning failures, fire/building evacuation, computer failures, hazardous material spills, injury
to employees, pandemic flu, disruption of phone service, etc. )
In the event that the building or information technology (IT) systems would be severely
challenged, a designated disaster recovery team, which includes Facility Management,
Maintenance, Safety, Laboratory/Executive Management, Public Relations, IT, QA and other
applicable personnel depending on the scope of the disaster, would assemble at a designated
area to assess the situation and formulate a plan.
.
6.5 Building Security
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Building keys and/or key fobs are distributed to employees as necessary.
Visitors to the laboratory sign in and out in a visitor’s logbook. A visitor is defined as any person
who visits the laboratory who is not an employee of the laboratory. In addition to signing into the
laboratory, the Environmental Health and Safety policies require the completion of specific EH
&S forms by all visitors and vendors. Visitors (with the exception of company employees) are
escorted by laboratory personnel at all times, or the location of the visitor is noted in the visitor’s
logbook.
7.0 QUALITY SYSTEM
7.1 Quality Policy Statement
The Quality Policy statement gives employees clear requirements for the production of
analytical data. As an organization, all personnel are committed to high quality professional
practice, testing and data, and service to our clients.
We strive to provide the highest quality data achievable by:
Reading and understanding all of the quality documents applicable to each position and
implementing the process in our work.
Following all recordkeeping requirements; describing clearly and accurately all activities
performed; recording “real time” as the task is carried out; understanding that it is never
acceptable to “back date” entries and should additional information be required at a later
date, the actual date and by whom the notation is made must be documented.
Ensuring data integrity through the completeness, consistency, impartiality and accuracy of
the data generated. Data is attributable, legible, contemporaneously recorded, original or a
true copy, and accurate (ALCOA). This applies to manual paper documentation and
electronic records.
Providing accountability and traceability for each sample analyzed through proper sample
handling, labeling, preparation, instrument calibration/qualification/validation, analysis, and
reporting; establishing an audit trail (the who, what, when, and why) that identifies date,
time, analyst, instrument used, instrument conditions, quality control samples (where
appropriate and/or required by the method), and associated standard material.
Emphasizing a total quality management process which provides impartiality, accuracy, and
strict compliance with agency regulations and client requirements, giving the highest degree
of confidence; understanding that meeting the requirements of the next employee in the
work flow process is just as important as meeting the needs of the external client.
Providing thorough documentation and explanation to qualify reported data that may not
meet all requirements and specifications, but is still of use to the client; understanding this
occurs only after discussion with the client on the data limitations and acceptability of this
approach.
Responding immediately to indications of questionable data, out-of-specification
occurrences, equipment malfunctions, and other types of laboratory problems, with
investigation and applicable corrective action; documenting these activities completely,
including the reasons for the decisions made.
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Providing a work environment that ensures accessibility to all levels of management and
encourages questions and expression of concerns on quality issues to management.
Eurofins recognizes that the implementation of a quality assurance program requires
management’s commitment and support as well as the involvement of the entire staff
Continually improve systems and manage risk to support quality improvement efforts in
laboratory, administrative and managerial activities
7.2 Ethics and Data Integrity
Eurofins Environment Testing America is committed to ensuring the integrity of its data and
meeting the quality needs of its clients. The laboratory operates our Ethics and Data Integrity
program under the guidance of Eurofin’s Key Guidance Document (KGD). The elements of our
Ethics and Data Integrity Program include:
An Ethics Policy (NDS Document No. CW-L-P-004) and Employee Ethics Statements.
Ethics and Compliance Officer/s (ECOs).
A Training Program.
Self-governance through disciplinary action for violations.
A confidential mechanism for anonymously reporting alleged misconduct and a means for
conducting internal investigations of all alleged misconduct. (NDSC Document No. CW-L-S-
002).
Procedures and guidance for recalling data if necessary (NDSC Document No. CW-Q-S-
005).
Effective external and internal monitoring system that includes procedures for internal audits
(Section 17).
Produce results, which are accurate and include QA/QC information that meets client pre-
defined Data Quality Objectives (DQOs).
Present services in a confidential, honest and forthright manner.
Provide employees with guidelines and an understanding of the Ethical and Quality
Standards of our Industry.
Provide procedures and guidance to ensure the impartiality and confidentiality of all data
and customer information.
Operate our facilities in a manner that protects the environment and the health and safety of
employees and the public.
Obey all pertinent federal, state and local laws and regulations and encourage other
members of our industry to do the same.
Educate clients as to the extent and kinds of services available.
Assert competency only for work for which adequate personnel and equipment are available
and for which adequate preparation has been made.
Promote the status of environmental laboratories, their employees, and the value of services
rendered by them.
7.3 Quality System Documentation
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The laboratory’s Quality System is communicated through a variety of documents.
Quality Assurance Manual – Eurofins EMLab P&K has one quality assurance manual to
address the quality management system applicable to all Eurofins EMLab P&K
facilities.NDSC Official Documents – Each laboratory may use the Guidance (instructional
use) documents at their discretion. Template documents are process documents that the
laboratory’s need to implement locally by using the document as is or as an outline to define
their internal practices that meet the minimum requirements of the template. Required
documents need to be implemented as is and listed in the laboratory’s document control list.
Key Guidance Documents (KGDs) - Documents compiled at the Group Service Centre
(GSC) level by Functional Leaders (document owners) aimed at providing specific Eurofins
groups of employees with guidelines necessary for the good conduct of their respective
work.
Laboratory SOPs and Policies– General and Technical
Laboratory QA/QC Policy Memorandums
7.3.1 Order of Precedence
In the event of a conflict or discrepancy between policies, the order of precedence is as follows:
Quality Management Plan (QMP)
NDSC Guidance Documents
KGDs
Laboratory Quality Assurance Manual (QAM)
Laboratory SOPs and Policies
Other (Work Instructions (WI), memos, flow charts, etc.)
NOTE: The laboratory has the responsibility and authority to operate in compliance with
regulatory requirements of the jurisdiction in which the work is performed. Where the QMP
conflicts with those regulatory requirements, the regulatory requirements of the jurisdiction shall
hold primacy. The laboratory’s QA Manual shall take precedence over the QMP in those cases.
7.4 QA/QC Objectives for the Measurement of Data
Quality Assurance (QA) is responsible for developing planned activities whose purpose is to
provide assurance to all levels of management that a quality program is in place within the
laboratory, and that it is functioning in an effective manner that is consistent with the
requirements of NELAP, ISO 17025, and any other regulatory agencies (i.e., states) in which the
laboratory maintains accreditation.
Quality Control (QC) is generally understood to be limited to the analyses of samples and to be
synonymous with the term “analytical quality control”. QC refers to the routine application of
statistically based procedures to evaluate and control the accuracy of results from analytical
measurements. The QC program includes procedures for estimating and controlling precision
and bias and for determining reporting limits.
Request for Proposals (RFPs) and Quality Assurance Project Plans (QAPP) provide a
mechanism for the client and the laboratory to discuss the data quality objectives in order to
ensure that analytical services closely correspond to client needs. In order to ensure the ability
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of the laboratory to meet the Data Quality Objectives (DQOs) specified in the QAPP, clients are
advised to allow time for the laboratory to review the QAPP before being finalized. The client is
responsible for developing the QAPP; however, the laboratory will provide support to the client
for developing the sections of the QAPP that concern laboratory activities.
Historically, laboratories have described their QC objectives in terms of precision, accuracy,
representativeness, comparability, completeness, selectivity and sensitivity (PARCCSS).
7.4.1 Precision
The objective is to meet the performance for precision demonstrated for the methods on similar
samples and to meet data quality objectives (DQOs) of the EPA and/or other regulatory
programs. Precision is defined as the degree of reproducibility of measurements under a given
set of analytical conditions (exclusive of field sampling variability). Precision is documented on
the basis of replicate analysis, usually duplicate or matrix spike (MS) duplicate samples.
7.4.2 Accuracy
The objective is to meet the performance for accuracy demonstrated for the methods on similar
samples and to meet data quality objectives (DQOs) of the EPA and/or other regulatory
programs. Accuracy is defined as the degree of bias in a measurement system. Accuracy may
be documented through the use of laboratory control samples (LCS) and/or MS. A statement of
accuracy is expressed as an interval of acceptance recovery about the mean recovery.
7.4.3 Representativeness
The objective is to provide data which is representative of the sampled medium.
Representativeness is defined as the degree to which data represent a characteristic of a
population or set of samples and is a measurement of both analytical and field sampling
precision. The representativeness of the analytical data is a function of the procedures used in
procuring and processing the samples. The representativeness can be documented by the
relative percent difference between separately procured, but otherwise identical samples or
sample aliquots.
The representativeness of the data from the sampling sites depends on both the sampling
procedures and the analytical procedures. Refer to laboratory SOPs for subsampling and
homogenization techniques appropriate to the analytical method.
7.4.4 Comparability
The objective is to provide analytical data for which the accuracy, precision, representativeness,
and reporting limit statistics are similar to these quality indicators generated by other
laboratories for similar samples, and data generated by the laboratory over time.
Comparability objective is documented by inter-laboratory studies carried out by regulatory
agencies or carried out for specific projects or contracts, by comparison of periodically
generated statements of accuracy, precision, and reporting limits with those of other
laboratories.
7.4.5 Completeness
The completeness objective for data is 90% (or as specified by a particular project), expressed
as the ratio of the valid data to the total data over the course of the project. Data will be
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considered valid if they are adequate for their intended use. Data usability will be defined in a
QAPP, project scope, or regulatory requirement. Data validation is the process for reviewing
data to determine its usability and completeness. If the completeness objective is not met,
actions will be taken internally and with the data user to improve performance. This may take
the form of an audit to evaluate the methodology and procedures as possible sources for the
difficulty or may result in a recommendation to use a different method.
7.4.6 Selectivity
Selectivity is defined as the capability of a test method or instrument to respond to a target
substance or constituent in the presence of non-target substances. Target analytes are separated
from non-target constituents and subsequently identified/detected through one or more of the
following, depending on the analytical method: extractions (separation), digestions (separation),
interelement corrections (separation), use of matrix modifiers (separation), specific retention
times (separation and identification), confirmations with different columns or detectors
(separation and identification), specific wavelengths (identification), specific mass spectra
(identification), and specific electrodes (separation and identification).
7.4.7 Sensitivity
Sensitivity refers to the amount of analyte necessary to produce a detector response that can be
reliably detected (above the Method Detection Limit) or quantified (above the Reporting Limit).
7.5 Criteria for Quality Indicators
The laboratory maintains a Quality Control Criteria Summary that contains tables that
summarize the precision and accuracy acceptability limits for performed analyses (EM-QA-R-
5730). This summary includes an effective date, is updated each time new limits are generated,
and are managed by the laboratory’s QA department. Unless otherwise noted, limits within
these tables are laboratory generated. Some acceptability limits are derived from US EPA
methods when they are required. Where US EPA method limits are not required, the laboratory
has developed limits from evaluation of data from similar matrices. Criteria for development of
control limits is contained in EM-AD-S-3548, Selection and Validation of Analytical Methods.
7.6 Statistical Quality Control
Statistically-derived precision and accuracy limits are required by selected methods (such as
NIOSH 7400) and programs (such as the AIHA-LAP, LLC Laboratory Accreditation Program).
The laboratory routinely utilizes statistically-derived limits to evaluate method performance and
determine when corrective action is appropriate. The current limits in the laboratory are entered
into the Laboratory Information Management System (LIMS), also referenced as LabServe. An
archive of all limits used within the laboratory is maintained within the LIMS/LabServe and
Bugzilla records. If a method defines the QC limits, the method limits are used.
If a method requires the generation of historical limits, the lab develops such limits from recent
data in the QC database of LIMS/LabServe following the guidelines described in Section 24. All
calculations and limits are documented and dated when approved and effective. On occasion, a
client requests contract-specified limits for a specific project.
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Current QC limits are entered and maintained in the LIMS/LabServe analyte database. As
sample results and the related QC are entered into LIMS/LabServe, the sample QC values are
compared with the limits in LIMS/LabServe to determine if they are within the acceptable range.
The analyst then evaluates if the sample needs to be re-analyzed.
7.6.1 QC Charts
All QC analyses (duplicates, replicates, daily references) including data reviews, must be
completed prior to release of results to clients. When QC analysis cannot be completed on the
same day, the results must be qualified with a report comment.
Proficiency Testing results, and data from additional QC analyses may be used in determining
analyst accuracy and precision, where applicable, for demonstration of continuing capability. If
proficiency testing problems arise, the analysts will be asked to review the samples again to
determine the source of error. If necessary, corrective actions will be implemented as
determined by Quality Assurance, the facility manager and/or the Cluster Leader based on the
nature of the problems.
Asbestos-PLM (Document EM-AS-S-1267)
Quality Control Requirements include duplicate analysis, Monthly Reference Sample, and
Proficiency testing.
Replicate and duplicate analyses are performed to evaluate the precision of a particular
analysis. The routine analysis portion is processed through the laboratory in a normal
manner. After the analysis has been completed, LabServe automated programming triggers
the selection of 5% of the completed bulk samples for replicate analysis and 5% for
duplicate analysis, based upon service, analyst and batch. The primary data along with the
replicate and duplicate data will be statistically analyzed and control limits will be determined
for the analyses (also automated by Labserve).
Proficiency Testing results and data from additional QC analyses may be used in
determining analyst accuracy and precision, where applicable, for demonstration of
continuing capability. If proficiency testing problems arise, the analysts will be asked to
review the samples again to determine the source of error. If necessary, corrective actions
will be implemented as determined by Quality Assurance, the facility manager and/or the
Cluster Leader based on the nature of the problems.
Asbestos - PCM (Document EM-AS-S-1260)
Microscopes must be adjusted at least once a day, per analyst. Also, the phase-shift
detection limit of the microscope must be checked weekly using the HSE/NPL phase-
contrast test slide.
Quality Control Requirements include duplicate analysis at the rate of 10%, Daily Reference
Sample, Round Robin and Proficiency testing.
The Reference Sample Quality Control Analysis (PCM) is performed by each analyst per
day of analysis to evaluate the precision and accuracy of each analyst for fiber identification.
The goal of performing Daily Reference Sample Quality Control Analysis is for continuous
improvement. The samples for the Daily Reference Sample Quality Control Analysis consist
of reference permanent slides, each of which contains varying asbestos or non-asbestos
fiber. Each analyst will analyze a randomly selected slide for each day, recording their
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results for the fiber counts. The identification by each analyst will be compared with the
known standard through LabServe QC criteria automation. Any discrepancies in data
comparison trigger an automated failure task for the analyst, who will be required to review
the slide again to determine the source of error, and document any associated corrective
actions.
Biannual ongoing demonstration of analyst proficiency using Proficiency Analytical Testing
(PAT) samples is required.
Training of Analysts (Document EM-AD-S-1646 and EM-AS-S-1261)
All new analysts will receive documented training on Eurofins EMLab P&K, LLC analysis
and sample preparation procedures as it relates to their individual job functions. The extent
and duration of the training will depend on the level of education and experience of the
trainee as outlined in Documents EM-AD-S-1646 and EM-AS-S-1261.
All analytical training will include, but not be limited to, maintaining documentation of the
training procedures and duration, a list of criteria documenting that the required steps
involved have been addressed during the training, testing using reference materials where
available, comparison of trainee results against analyst results, and providing the trainee
with training documents and reference texts.
Analysts and technicians will be authorized to perform a specific task and operate specific
instruments once the applicable Training Acknowledgment and Authorization forms have
been completed and signed by the trainee and trainer and all related data, reviews, and
records have been submitted to Quality Assurance for final review and inclusion in analyst
training records.
Analysis of Unknown Samples and Reference Materials
Where applicable to job responsibilities, analysts will analyze unknown bacterial and/or
fungal organisms at least monthly to ensure the consistency of identification. Selection of
organisms will be made randomly from laboratory stock cultures.
Where applicable to job responsibilities, analysts will analyze unknown samples for asbestos
identification and quantitation.
Documentation of the analyses will be maintained by the Quality Assurance department.
Reference Materials
Eurofins EMLab P&K, LLC maintains a library of reference materials that are accessible to
all analysts. Each facility is responsible for maintaining an individual list of reference texts
which are maintained in LabServe.
Eurofins EMLab P&K, LLC maintains a library of cultures and reference slides. EMPAT and
other microbiological reference materials are grown and analyzed by the laboratory on a
routine basis.
Asbestos reference samples such as NIST SRM #1866 and SRM #1867, or equivalent, are
also maintained in applicable laboratories, if available.
The laboratory retains and utilizes proficiency testing materials for use as in-house
instructional materials. The proficiency test results are used to verify accuracy and precision
for each analyst and to judge the analysts' overall performance. Proficiency test results are
used for inter-analyst comparisons and entered into the laboratory’s management system
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records. The laboratory determines precision on the qualitative and quantitative analyses of
samples by: repeatability - repeat analyses by the same analyst; -comparison of results from
multiple slide mounts of the same material; reproducibility - analysis of samples by multiple
analysts if possible (single analyst laboratories require more interlaboratory data); and
interlaboratory analysis - analysis of samples by other laboratories. The laboratory also
determines the accuracy of the qualitative and quantitative analyses of samples by: analysis
of proficiency testing materials; analysis of standards either prepared in-house or
purchased; and analysis of samples using independent methods (e.g., XRD, gravimetric,
etc.).
When analyzing QC samples (duplicates, replicates) or reference samples, analysts must
complete the analysis and enter the results into Labserve or record them on appropriate
data sheets, without any assistance from or discussions with other analysts.
Analysts should not edit the result they reported in Labserve or recorded on appropriate
data sheets.
Demonstration of Capability: (Document EM-AD-S-1646)
Semi-annual demonstrations of capability may be accomplished by successful completion of:
duplicate analyses;
replicate analyses;
daily reference analyses and
proficiency testing samples.
Acceptable performance criteria for Ongoing Demonstrations of competency are based on
the performance characteristics for the method, established either from the data collected
from the analysis of QC check samples, those already promulgated by the method, those
set by an outside provider or an error rate of ≤1% for Asbestos PLM, and ≤5% for other
analyses over a six month period.
For example, if an analyst is qualified to perform bacterial analyses and is required to
participate in the AIHA EMPAT Bacterial Culturable Proficiency Testing program, the
acceptable performance for their Ongoing Demonstration of Competency would be a score
of ≥85%, which is set by the provider
7.7 Quality System Metrics
In addition to the QC parameters discussed above, the entire Quality System is evaluated on a
monthly basis through the use of specific metrics (refer to Section 18). These metrics are used
to drive continuous improvement in the laboratory’s Quality System.
8.0 DOCUMENT CONTROL
8.1 Overview
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The QA Department is responsible for the control of documents used in the laboratory to ensure
that approved, up-to-date documents are in circulation and out-of-date (obsolete) documents
are archived or destroyed. The following documents, at a minimum, must be controlled:
Laboratory Quality Assurance Manual
Laboratory Standard Operating Procedures (SOP)
Laboratory Policies
Work Instructions and Forms
NDSC Documents1
KGDs1
1Includes locally implemented documents that are document controlled within the laboratory’s
document control system. The NDSC and/or KGD documents are only considered controlled
when they are read on the intranet site. Printed copies are considered uncontrolled unless the
laboratory physically distributes them as controlled documents. A detailed description of the
procedure for issuing, authorizing, controlling, distributing, and archiving NDSC Official
Documents is found in Document CW-Q-S-001, NDSC Document Control and Archiving. The
laboratory’s internal document control procedure is defined in SOP No. EM-QA-S-2059. All
documents that are part of the Eurofins EMLab P&K quality assurance system, either internally
generated or external are controlled through the Eurofins EMLab P&K LabServe Document
Control system. The formal distribution of documents to Eurofins EMLab P&K employees is
conducted through a companywide electronic release of revisions in LabServe. All users with
log in credentials are afforded access to current revisions of released documents through the
LabServe Document control module.
The laboratory QA Department also maintains access to various references and document
sources integral to the operation of the laboratory. This includes reference methods and
regulations. Instrument manuals (hard or electronic copies) are also maintained by the
laboratory.
The laboratory maintains control of records for raw analytical data and supporting records such as
audit reports and responses, logbooks, standard logs, training files, MDL studies, Proficiency
Testing (PT) studies, certifications and related correspondence, and corrective action reports
(however named). Raw analytical data consists of bound logbooks, instrument printouts, any other
notes, magnetic media, electronic data, and final reports.
8.2 Document Approval and Issue
The pertinent elements of the document control system include a unique document title and
number, pagination, the total number of pages of the item or an ‘end of document’ page, the
effective date, revision number, and the laboratory’s name. The QA personnel are responsible
for the maintenance of this system.
Controlled documents are authorized by the QA Department and Regional Laboratory Directors.
In some cases, the document owner and/or facility technical managers/approved signatories,
may be asked to review controlled documents prior to release. In order to develop a new
document, a document owner/author submits an electronic draft to the QA Department for
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suggestions, review, and approval before use. Upon approval, QA personnel add the identifying
version information to the document and retain that document as the official document on file.
That document is then electronically registered and distributed to applicable facilities via
LabServe Document Control. Changes to documents stored electronically will be strictly
controlled by the LabServe document control system. Handwritten changes to SOPs are not
allowed.
The QA Department maintains a list of the official versions of controlled documents. A Master
List of Eurofins EMLab P&K Controlled Documents is maintained in LabServe and can be
accessed by all employees using the “My Docs" tab on the LabServe home page.
Quality System Policies and Procedures will be reviewed at a minimum of every two years and
revised as appropriate. Changes to documents occur when a procedural change warrants.
8.3 Procedures for Document Control Policy
For changes to the QA Manual, and all other quality documents, refer to SOP No. EM-QA-S-
2059. Uncontrolled copies must not be used within the laboratory. Printing of Eurofins EMLab
P&K SOPs is not permissible unless strictly and exclusively used for review or training
purposes. Any document printed for this purpose must be labeled as “UNCONTROLLED” or
“OBSOLETE” to indicate it is not a controlled copy. Any official document printed for these
purposes must be discarded/shredded immediately following completion of review or training.
Previous revisions are removed from general access points and stored within the LabServe
Document Control module, and are not accessible to lab personnel. Current electronic copies
are stored within LabServe Document Control and are accessible to personnel via the “MyDocs”
link after logging in with individual system credentials.
For changes to SOPs, refer to SOP No. EM-QA-S-2059, Document Control and Control of
Records.
Forms, worksheets, work instructions and information are organized by department in the
LabServe Document Control module. The procedure for the care of these documents is in SOP
EM-QA-S-2059.
8.4 Obsolete Documents
All invalid or obsolete documents are removed, or otherwise prevented from unintended use.
The laboratory has specific procedures as described above to accomplish this. In general,
obsolete documents are removed from general access points in LabServe Document Control. A
copy of the obsolete document is archived within LabServe Document Control according to SOP
No. EM-QA-S-2059.
9.0 SERVICE TO THE CLIENT
9.1 Overview
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The laboratory has established procedures for the review of work requests and contracts, oral or
written. The procedures include evaluation of the laboratory’s capability and resources to meet
the contract’s requirements within the requested time period. All requirements, including the
methods to be used, must be adequately defined, documented and understood. For many
environmental sampling and analysis programs, testing design is site or program specific and
does not necessarily fit into a standard laboratory service or product. It is the laboratory’s intent
to provide both standard and customized environmental laboratory services to our clients.
A thorough review of technical and QC requirements contained in contracts is performed to
ensure project success. The appropriateness of requested methods , and the lab’s capability to
perform them must be established. Projects, proposals, and contracts are reviewed for
adequately defined requirements and the laboratory’s capability to meet those requirements.
Alternate test methods that are capable of meeting the clients’ requirements may be proposed
by the lab. A review of the lab’s capability to analyze non-routine analytes is also part of this
review process.
All projects, proposals and contracts are reviewed for the client’s requirements in terms of
compound lists, test methodology requested, sensitivity (detection and reporting levels),
accuracy, and precision requirements (% Recovery and RPD). The reviewer ensures that the
laboratory’s test methods are suitable to achieve these requirements and that the laboratory
holds the appropriate certifications and approvals to perform the work. The laboratory and any
potential subcontract laboratories must be certified, as required, for all proposed tests.
Electronic or hard copy deliverable requirements are evaluated against the laboratory’s capacity
for production of the documentation.
If the laboratory cannot provide all services but intends to subcontract such services, whether to
another Eurofins facility on the same LIMS or to an outside firm, this will be documented and
discussed with the client prior to contract approval. (Refer to Section 10 for Subcontracting
Procedures.)
The laboratory informs the client of the results of the review if it indicates any potential conflict,
non-conformance, lack of accreditation, or inability of the lab to complete the work satisfactorily.
Any discrepancy between the client’s requirements and the laboratory’s capability to meet those
requirements is resolved in writing before acceptance of the contract. It is necessary that the
contract be acceptable to both the laboratory and the client. Amendments initiated by the client
and/or Eurofins EMLab P&K are documented in writing.
All contracts, QAPPs, Sampling and Analysis Plans (SAPs), contract amendments, and
documented communications become part of the project record.
The same contract review process used for the initial review is repeated when there are
amendments to the original contract by the client, and the participating personnel are informed
of the changes.
9.2 Review Sequence and Key Personnel
Appropriate personnel will review the work request at each stage of evaluation.

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For routine projects and other simple tasks, a review of standard COC submissions by the
receiving and log in staff is considered adequate. The receiving and log in staff confirm that the
laboratory has any required certifications, that it can meet the clients’ data quality and reporting
requirements and that the lab has the capacity to meet the clients turn around needs. Routine
project submission reviews are performed according to SOP No. EM-SM-S-1288, Sample
Receiving, and EM-SM-S-1993, Sample Log-In.
For new, complex or large projects, the proposed contract is given to the Regional Account
Manager or Project Manager, who will decide which lab will receive the work based on the
scope of work and other requirements, including certification, testing methodology, and available
capacity to perform the work. The contract review process is outlined in NDSC Document No.
CA-L-P-002, Contract Compliance Policy.
This review encompasses all facets of the operation. The scope of work is distributed to the
appropriate personnel, as needed based on scope of contract, to evaluate all of the
requirements shown above (not necessarily in the order below):
Contract Administrator
Laboratory Project Manager
Laboratory Cluster Leaders and/or Technical Managers
Account Executives
Quality Managers
Laboratory Environmental Health and Safety Managers/Directors
The Laboratory Director reviews the formal laboratory quote and makes final acceptance for
their facility.
The Sales Director, Contract Administrator, Account Executive or Proposal Coordinator then
submits the final proposal to the client.
In the event that one of the above personnel is not available to review the contract, his or her
back-up will fulfill the review requirements.
9.3 Balancing Laboratory Capacity and Workload
Evaluating laboratory capacity to perform specific projects is the responsibility of the Business
Unit Manager, Cluster Leaders, Facility Managers, and Client Services. Many analysts are
cross-trained to perform a variety of tests, and there is redundant equipment available in case of
malfunctions. This minimizes the need to evaluate small and medium size projects against
capacity available to complete them. Large and complex projects are reviewed against capacity
estimates before bids are submitted to ensure that the client’s analysis schedule is met.
Regularly scheduled meetings are held between laboratory management, PMs, Client Services
and QA personnel to review progress with current projects, as well as special requirements of
new work scheduled for the laboratory. Laboratory capacity and backlog is tracked on a
continuous basis using information from the Laboratory Sample Information System (LIMS)
including turnaround time, and work in-house.
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9.4 Documentation
Copies of all signed and/approved contracts are maintained within LabServe account records.
Appropriate records are maintained for every contract or work request. All stages of the
contract review process are documented and include records of any significant changes.

The contract will be distributed to and maintained by the appropriate sales/marketing personnel
and the Account Executive. A copy of the contract and formal quote will be filed with the
laboratory PM and the Laboratory Director.
Records are maintained of pertinent discussions with a client relating to the client’s
requirements or the results of the work during the period of execution of the contract. The PM
keeps a phone log of conversations with the client.
9.4.1 Project-Specific Quality Planning
Communication of contract specific technical and QC criteria is an essential activity in ensuring
the success of site specific testing programs. To achieve this goal, a PM is assigned to each
client. It is the PM’s responsibility to ensure that project-specific technical and QC requirements
are effectively evaluated and communicated to the laboratory personnel before and during the
project. QA department involvement may be needed to assist in the evaluation of custom QC
requirements.
PM’s are the primary client contact and they ensure resources are available to meet project
requirements, they coordinate opportunities and work with laboratory management and supervisory
staff to ensure available resources are sufficient to perform work for the client’s project.
Prior to work on a new project, the dissemination of project information and/or project opening
meetings may occur to discuss schedules and unique aspects of the project. Items to be
discussed may include the project technical profile, turnaround times, holding times, methods,
analyte lists, reporting limits, deliverables, sample hazards, or other special requirements. The PM
introduces new project information to maximize production and client satisfaction, while
maintaining quality.Project notes may be associated with each sample batch as a reminder upon
sample receipt and analytical processing.
Any change that may occur within an active project is agreed upon between the client/regulatory
agency and the PM/laboratory. These changes (e.g., use of a non-standard method or
modification of a method) and approvals must be documented prior to implementation.
Documentation pertains to any document (e.g., letter, e-mail, variance, contract addendum), which
has been signed by both parties.
Such changes are also communicated to the laboratory either during operations meetings or via
LabServe project tasks. Such changes are updated to the project notes and are introduced to the
managers at these meetings. The laboratory staff is then introduced to the modified requirements
via the PM or the individual laboratory Technical Manager. After the modification is implemented
into the laboratory process, documentation of the modification is made in the case narrative of the
data report(s), where applicable.
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The laboratory strongly encourages client visits to the laboratory and for formal/informal
information sharing session with employees in order to effectively communicate ongoing client
needs as well as project specific details for customized testing programs.
9.5 Special Services
The laboratory cooperates with clients and their representatives to monitor the laboratory’s
performance in relation to work performed for the client. It is the laboratory’s goal to meet all
client requirements in addition to statutory and regulatory requirements. The laboratory has
procedures to ensure confidentiality to clients (Section 15 and 25).
The laboratory’s standard procedures for reporting data are described in Section 25. Special
services are also available and provided upon request. These services include:
Reasonable access for our clients or their representatives to the relevant areas of the
laboratory for the witnessing of tests performed for the client.
Assisting client-specified third party data validators as specified in the client’s contract.
Supplemental information pertaining to the analysis of their samples. Note: An additional
charge may apply for additional data/information that was not requested prior to the time of
sample analysis or previously agreed upon.
When the client requests a statement of conformity to a specification or standard based on the
analysis performed by the laboratory (e.g., pass/fail, in-tolerance/out-of-tolerance), the decision
rule shall be clearly defined. Unless inherent in the requested specification or standard, the
decision rule selected shall be communicated to the client. Associated reporting requirements
are addressed in Section 25.2.18.
9.6 Client Communication
PMs are the primary communication link to the clients. They shall inform their clients of any
delays in project completion as well as any non-conformances in either sample receipt or
sample analysis. Project management will maintain ongoing client communication throughout
the entire client project.
Technical Managers and/or Regional Laboratory Directors are available to discuss any technical
questions or concerns that the client may have.
9.7 Reporting
The laboratory works with our clients to produce any special communication reports required by
the contract.
9.8 Client Surveys
The laboratory assesses both positive and negative client feedback. The results are used to
improve overall laboratory quality and client service. Eurofins Sales and Marketing teams
periodically develop lab and client specific surveys to assess client satisfaction.
When a complaint is received, we determine, to the best of our ability, the extent of the issue
and what data is in question. The person receiving the complaint documents this information
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and promptly forwards it to the appropriate management personnel where the work in question
was performed. If a data reporting error is discovered, the final report and/or data must be
regenerated with the correct value(s).
The person receiving the complaint is responsible for entering client concerns into Labserve via
the task system, ensuring that concerns selections are marked. In some cases, an ICAT is
initiated to address and document the situation. While an individual issue may not warrant a
formal investigation, QA monitors these issues for potential trends and will issue an ICAT if a
trend is evident.
10.0 SUBCONTRACTING OF TESTS
10.1 Overview
For the purpose of this quality manual, the phrase subcontract laboratory refers to a laboratory
external to the Eurofins EMLab P&K. The phrase “work sharing” refers to internal transfers of
samples between the Eurofins EMLab P&K laboratories. The term outsourcing refers to the act
of subcontracting tests.
When contracting with our clients, the laboratory makes commitments regarding the services to
be performed and the data quality for the results to be generated. When the need arises to
outsource testing for our clients because project scope, changes in laboratory capabilities,
capacity, or unforeseen circumstances, we must be assured that the subcontractors or work
sharing laboratories understand the requirements and will meet the same commitments we
have made to the client. Refer to Eurofins EMLab P&K’s Sample Receiving SOP (EM-SM-S-
1288) for Subcontracting Procedures and the Work Sharing Process.
When outsourcing analytical services, the laboratory will assure, to the extent necessary, that
the subcontract or work sharing laboratory maintains a program consistent with the
requirements of this document, the requirements specified in the current ISO/IEC 17025 and/or
the client’s Quality Assurance Project Plan (QAPP). All QC guidelines specific to the client’s
analytical program are transmitted to the subcontractor and agreed upon before sending the
samples to the subcontract facility. Additionally, work requiring accreditation will be placed with
an appropriately accredited laboratory. The laboratory performing the subcontracted work will
be identified in the final report, as will non-TNI accredited work where required.
Project Managers (PMs) or other responsible Client Service members, for the Export Lab (i.e.,
the Eurofins EMLab P&K laboratory that transfers samples to another laboratory) are
responsible for obtaining client approval prior to subcontracting any samples. The laboratory will
advise the client of a subcontract arrangement in writing and when possible approval from the
client shall be obtained and retained in the project folder. Standard Eurofins EMLab P&K Terms
& Conditions include the flexibility to work-share samples within the Eurofins EMLab P&K
laboratories. Therefore, additional advance notification to clients for intra-laboratory work-shares
is not necessary unless specifically required by a client contract. Unless the client has specified
a particular location where Eurofins EMLab P&K, LLC is to perform its services, Eurofins EMLab
P&K, LLC may perform services for the client at any laboratory in its network provided that for
the samples being work-shared, the receiving lab has the same requested services on its Scope
of Accreditation as the lab to which the samples were originally sent. Before samples are work-
shared, Eurofins EMLab P&K, LLC will advise the client of the arrangement in writing by
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requesting a Transfer Approval/Disapproval Agreement to be completed by the client. These
agreements will be kept on file for future use. Every attempt will be made to gain the client’s
approval in writing using the Transfer Approval/Disapproval Agreement. If the client does not
respond to the approval request, Eurofins EMLab P&K, LLC retains the right, at its discretion, to
work-share services ordered by the client to another Eurofins EMLab P&K, LLC laboratory or
other laboratories.
Note: In addition to the client, some regulating agencies (e.g., USDA) or contracts require
notification prior to placing such work .
10.2 Qualifying and Monitoring Subcontractors
Whenever a PM or Regional Account Manager becomes aware of a client requirement or
laboratory need where samples must be outsourced to another laboratory, the other
laboratory(s) shall be selected based on the following:
Subcontractors specified by the client - In these circumstances, the client assumes
responsibility for the quality of the data generated from the use of a subcontractor.
Subcontractors reviewed by Eurofins EMLab P&K – Firms which have been reviewed by the
company and are known to meet standards for accreditations (e.g., AIHA-LAP, LLC, NVLAP,
State specific accreditations, TNI, etc. ); technical specifications; legal and financial
information.
A listing of vendors is available on the Eurofins Environment Testing TestAmerica intranet site.
All Eurofins EMLab P&K laboratories are pre-qualified for work sharing provided they hold the
appropriate accreditations and can adhere to the project/program requirements. Client approval
is not necessary unless specifically required by the contract. In these cases, the client must
provide acknowledgement that the samples can be sent to that facility (an e-mail is sufficient
documentation or if acknowledgement is verbal, the date, time, and name of person providing
acknowledgement must be documented). The originating laboratory is responsible for
communicating all technical, quality, and deliverable requirements as well as other contract
needs. (NDSC Document No. CA-C-S-001, Work Sharing Process).
Eurofins EMLab P&K, LLC will be held responsible for data produced as a result of
subcontracting of work, except in the case where the client or a regulatory authority specifies
which subcontractor is to be used.
Prior to submitting samples to subcontractors the samples may be logged into the
LIMS/LabServe and assigned a Eurofins EMLab Project ID number. A Chain of Custody (COC)
must be signed to document transfer to the subcontracting laboratory. All data reported from a
subcontractor shall list the name of the laboratory performing the analysis. A copy of the COC
must be part of the report sent to Eurofins EMLab P&K, LLC after completion of the analysis by
the subcontractor.
10.2.1 When the potential sub-contract laboratory has not been previously approved, RAMs
or PMs may nominate a laboratory as a subcontractor based on need. The decision to nominate
a laboratory must be approved by the Business Unit Manager or Cluster Leader. The Business
Unit Manager or Cluster Leader requests that the QA Manager or PM begin the process of
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approving the subcontract laboratory as outlined in NDSC Document No. CW-L-S-004,
Subcontracting Procedures.
Once the appropriate accreditation and legal information is received by the laboratory, it is
evaluated for acceptability and forwarded to the NDSC Quality Information Manager (QIM) for
review. After the NDSC QIM reviews the documents for completeness, the information is
forwarded to the Finance Department for formal signature and contracting with the laboratory.
The approved vendor will be added to the approved subcontractor list on the intranet site, and
the finance group is concurrently notified.
The client will assume responsibility for the quality of the data generated from the use of a
subcontractor they have requested the lab to use. The qualified subcontractors on the intranet
site are known to meet minimal standards. Eurofins EMLab P&K does not certify laboratories.
The subcontractors on our approved list can only be recommended to the extent that we would
use them.
10.3 Oversight and Reporting
The status and performance of qualified subcontractors will be monitored by NDSC, and
includes an annual review process (see NDSC Document No. CW-L-S-004). Any problems
identified will be brought to the attention of NDSC and/or Procurement personnel.
Complaints shall be investigated. Documentation of the complaint, investigation, and
corrective action will be maintained in the subcontractor’s file on the intranet site.
Complaints are posted using the Vendor Performance Report.
Information shall be updated on the intranet when new information is received from the
subcontracted laboratories.
Subcontractors in good standing will be retained on the intranet listing. Client Services
personnel will notify all Eurofins EMLab P&K laboratories, NDSC, and Corporate Contracts if
any laboratory requires removal from the intranet site. This notification will be posted on the
intranet site and e-mailed to all Client Services Personnel, Cluster Leaders, QA Managers,
and Sales Personnel.
Prior to initially sending samples to the subcontracted laboratory, the PM confirms their
certification status to determine if it’s current and scope-inclusive. The information is
documented within the project records.
10.3.1 All subcontracted samples must be accompanied by a Eurofins EMLab P&K Chain of
Custody (COC). A copy of the original COC sent by the client must be available in LIMS for all
samples workshared within Eurofins EMLab P&K. Client COCs are only forwarded to external
subcontractors when samples are shipped directly from the project site to the subcontractor lab.
Under routine circumstances, client COCs are not provided to external subcontractors.
Through communication with the subcontracted laboratory, the PM monitors the status of the
subcontracted analyses, facilitates successful execution of the work, and ensures the timeliness
and completeness of the analytical report.
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Non-TNI accredited work must be identified in the subcontractor’s report as appropriate. If TNI
accreditation is not required, the report does not need to include this information.
Reports submitted from subcontractor laboratories are not altered and are included in their
original form in the final project report. This clearly identifies the data as being produced by a
subcontractor facility. If subcontract laboratory data is incorporated into the laboratory’s EDD
(i.e., imported), the report must explicitly indicate which lab produced the data for which
methods and samples.
Note:The results submitted by a Eurofins EMLab P&K work sharing laboratory may be
transferred electronically and the results reported by the Eurofins EMLab P&K work sharing lab
are identified on the final report. The report must explicitly indicate which lab produced the data
for which methods and samples. The final report must include a copy of the completed COC for
all work sharing reports.
10.4 Contingency Planning
The full qualification of a subcontractor may be waived to meet emergency needs. This decision
and justification must be documented in the project files, and the ‘Purchase Order Terms And
Conditions For Subcontracted Laboratory Services’ must be sent with the samples and COC.
In the event this provision is utilized, the laboratory (e.g., PM) will be required to verify and
document the applicable accreditations of the subcontractor. All other quality and accreditation
requirements will still be applicable, but the subcontractor need not have signed a subcontract
agreement with Eurofins EMLab P&K at this time.
The use of any emergency subcontractor will require the PM to complete a JDE New Vendor
Add Form in order to process payment to the vendor and add them to LIMS/LabServe. This
form requires the user to define the subcontractor’s category/s of testing and the reason for
testing.
10.4 Use of NELAP and A2LA Logo
It is not laboratory policy to use these logos on any company letterhead, including analytical
reports.
11.0 PURCHASING SERVICES AND SUPPLIES
11.1 Overview
Evaluation and selection of suppliers and vendors is performed, in part, on the basis of the
quality of their products, their ability to meet the demand for their products on a continuous and
short term basis, the overall quality of their services, their past history, and competitive pricing.
This is achieved through evaluation of objective evidence of quality furnished by the supplier,
which can include certificates of analysis, recommendations, and proof of historical compliance
with similar programs for other clients. To ensure that quality critical consumables and
equipment conform to specified requirements, which may affect quality, all purchases from
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specific vendors are approved by a member of the supervisory or management staff. Capital
expenditures are made in accordance with Eurofins TestAmerica’s Fixed Asset Acquisition,
Retention and Safeguarding SOP No. CW-F-S-007.
Contracts will be signed in accordance with the laboratory’s authorization matrix, or refer to
NDSC Document No. CW-F-P-002. Request for Proposals (RFP’s) will be issued where more
information is required from the potential vendors than just price. Process details are available
in NDSC Document No. CW-F-P-004, Guidance on Procurement and Contracts Policy. RFP’s
allow the laboratory to determine if a vendor is capable of meeting requirements such as
supplying all of the Eurofins TestAmerica facilities, meeting required quality standards and
adhering to necessary ethical and environmental standards. The RFP process also allows
potential vendors to outline any additional capabilities they may offer.
11.2 Glassware
Glassware used for volumetric measurements must be Class A or verified for accuracy
according to laboratory procedure. Pyrex (or equivalent) glass should be used where possible.
For safety purposes, thick-wall glassware should be used where available.
11.3 Reagents, Standards & Supplies
Purchasing guidelines for equipment, consumables, and reagents must meet the requirements
of the specific method and testing procedures for which they are being purchased.
11.3.1 Purchasing
Chemical reagents, solvents, glassware, and general supplies are ordered as needed to
maintain sufficient quantities on hand. Materials used in the analytical process must be of a
known quality. The wide variety of materials and reagents available makes it advisable to
specify recommendations for the name, brand, and grade of materials to be used in any
determination. This information is contained in the method SOP. Requests for reagents,
standards, or supplies are directed to facility managers, Cluster Leaders, or designee. For labs
using on-site consignment, analyst may check the item out of the on-site consignment system
that contains items approved for laboratory use.
11.3.2 Receiving
It is the responsibility of the facility manager, or designee, to receive the shipment. It is the
responsibility of the receiving personnel to document the date materials were received. Once
the ordered reagents or materials are received, the receiver compares the information on the
label or packaging to the original order to ensure that the purchase meets the quality level
specified. This is documented through the addition of the received date and initials to the
information present on the packing slip. All reagents and media received by the laboratory for
internal use must be dated and initialed upon receipt, and assigned an expiration date if one is
not assigned by the manufacturer. All items are to be stored according to manufacturer's
instructions and SDS requirements. The Certification of Analysis and other Quality Control
records for specific medium and reagent lots supplied by the vendors are maintained at each
facility. (Supply Receiving and Distribution East, Document EM-MR-S-1209, and Supply
Receiving and Distribution West, Document EM-MR-S-7350)
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Materials may not be released for use in the laboratory until they have been inspected, verified
as suitable for use, and the inspection/verification has been documented. Materials which are
found to not meet expected requirements and level of quality either at receiving or upon initial
use, are to be set aside for return to the vendor. Facility managers, or designees, are to be
notified of any negative trend noted in quality of vendor materials for further evaluation and
vendor replacement as needed. Trends are reported immediately by the laboratory staff to the
Purchasing Group.
The Purchasing Group will work through the appropriate channels to gather the information
required to clearly identify the problem and will contact the vendor to report the problem and to
make any necessary arrangements for exchange, return authorization, credit, etc.
Any media or reagents generated by the laboratory must follow the prescribed procedure for
quality control checking prior to use in analysis. In-house generated standards or reagents
must complete quality control checks, before being used in the processing of samples. All
standards and reagents produced by the laboratory are produced with a description of content,
preparer’s initials, manufacturer and lot number of parent material, pH (if applicable), assigned
lot numbers and expiration dates.
All standards used to calibrate instruments or measuring devices must be traceable to the NIST,
or equivalent national or international standard.
Safety Data Sheets (SDSs) are available online through the Company’s intranet website.
Anyone may review these for relevant information on the safe handling and emergency
precautions of on-site chemicals.
11.3.3 Specifications
Methods used in the laboratory specify the grade of reagent that must be used in the procedure.
If the quality of the reagent is not specified, analytical reagent grade will be used. It is the
responsibility of the analyst to check the procedure carefully for the suitability of grade of
reagent.
Reagents, media, and chemicals must not be used past the manufacturer’s expiration date and
must not be used past the expiration time noted in a method SOP. If expiration dates or
recommended retest dates are not provided, the laboratory may contact the manufacturer to
determine an expiration date. If no recommended expiration is available, the laboratory will
assume a 5 year expiration from date of manufacture.
Wherever possible, standards must be traceable to national or international standards of
measurement or to national or international reference materials. Records to that effect are
available to the user.
Where applicable, compressed gases in use are checked for pressure and secure positioning
daily. To prevent a tank from going to dryness, or introducing potential impurities, the pressure
should be closely watched as it decreases to approximately 15% of the original reading, at
which point it should be replaced. For example, a standard sized laboratory gas cylinder
containing 3,000 psig of gas should be replaced when it drops to approximately 500 psig. The
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quality of the gases must meet method or manufacturer specification or be of a grade that does
not cause any analytical interference.
Water used in the preparation of samples, standards or reagents must meet the applicable
water quality requirements noted in individual method SOPs.
The laboratory may purchase reagent grade (or other similar quality) water for use in the
laboratory. This water must be certified clean by the supplier for all target analytes or otherwise
verified by the laboratory prior to use. This verification is documented.
Purchased bottleware used for sampling must be certified clean and the certificates must be
maintained. If uncertified sampling bottleware is purchased, all lots must be verified clean prior
to use. This verification must be maintained. (Reference SOPs EM-MR-S-1209 and EM-MR-S-
7350.)
11.3.4 Storage
Reagent and chemical storage is important from the aspects of both integrity and safety. Light-
sensitive reagents may be stored in brown-glass containers. Storage conditions are per the
NDSC Environmental Health & Safety Manual Document No. CW-E-M-001, the local laboratory
EH&S manual addendum and method SOPs or manufacturer instructions.
11.4 Purchase of Equipment / Instruments / Software
When a new piece of equipment is needed, either for additional capacity or for replacing
inoperable equipment, the analyst or supervisor makes a supply request to the Facility Manager,
Cluster Leader, or the Business Unit Manager. If they agree with the request, the procedures
outlined in NDSC Document No. CA-T-P-001, Qualified Products List, are followed. A decision is
made as to which piece of equipment can best satisfy the requirements. The appropriate
written requests are completed and purchasing places the order.
Upon receipt of a new or used piece of equipment, an identification name is assigned and
added to the equipment list. Its capability is assessed to determine if it is adequate or not for
the specific application. For instruments, a calibration curve is generated, followed by MDLs,
Demonstration of Capabilities (DOCs), and other relevant criteria (refer to Section 19). For
software, its operation must be deemed reliable and evidence of instrument verification must be
retained by the QA Department. Software certificates supplied by the vendors are filed with the
QA Department. The manufacturer’s operation manual is retained locally at each facility.
11.5 Services
Service to analytical instruments (except analytical balances) is performed on an as needed
basis. Routine preventative maintenance is discussed in Section 20. The need for service is
determined by analysts and/or Technical Managers. The service providers that perform the
services are approved by the Facility Manager.
Analytical balances are serviced and calibrated annually in accordance with SOP EM-EQ-S-
1584. The calibration and maintenance services are performed on-site, and the balances are
returned to use immediately following successful calibration. Calibration certificates are filed for
reference. If the calibration was unsuccessful, the balance is immediately removed from service
and segregated pending either further maintenance or disposal.
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Calibration services for support equipment such as thermometers, weight sets, autopipettors,
etc., are obtained from vendors with current and valid ISO/IEC 17025 accreditation for
calibration of the specific piece of equipment. Prior to utilizing the vendor’s services, the
vendor’s accreditation status is verified. Once the equipment has been calibrated, the
calibration certificates are reviewed by the QA department, and documentation of the review is
filed with the calibration certificates. The equipment is then returned to service within the
laboratory.
11.6 Suppliers
The laboratory selects vendors through a competitive proposal / bid process, strategic business
alliances or negotiated vendor partnerships (contracts). This process is defined in the NDSC
Procurement & Contracts Policy (Document No. CW-F-P-004). The level of control used in the
selection process is dependent on the anticipated spending amount and the potential impact on
the laboratory’s business. Vendors that provide test and measuring equipment, solvents,
standards, certified containers, instrument related service contracts or subcontract laboratory
services shall be subject to more rigorous controls than vendors that provide off-the-shelf items
of defined quality that meet the end use requirements. The purchasing system includes all
suppliers/vendors that have been approved for use.
Evaluation of suppliers is accomplished by ensuring the supplier ships the product or material
ordered and that the material is of the appropriate quality. This is documented by signing off on
packing slips or other supply receipt documents. The purchasing documents contain the data
that adequately describe the services and supplies ordered.
Any issues of vendor performance are to be reported immediately by the laboratory staff to
thePurchasing Group by completing a Vendor Performance Report.
The Purchasing Group will work through the appropriate channels to gather the information
required to clearly identify the problem and will contact the vendor to report the problem and to
make any necessary arrangements for exchange, return authorization, credit, etc.
Suppliers are subject to re-evaluation, as deemed appropriate, through the use of Vendor
Performance Reports used to summarize and review to determine corrective action necessary,
or service improvements required by vendors
The laboratory has access to a listing of all approved suppliers of critical consumables, supplies
and services. This information is provided through the purchasing system.
11.6.1 New Vendor Procedure
Laboratory employees who wish to request the addition of a new vendor must complete a
Vendor Add Request Form.
New vendors are evaluated based upon criteria appropriate to the products or services provided
as well as their ability to provide those products and services at a competitive cost. Vendors are
also evaluated to determine if there are ethical reasons or potential conflicts of interest with
laboratory employees that would make it prohibitive to do business with them as well as their
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financial stability. The QA Department and/or the Cluster Leaders and Business Unit Manager
are consulted with vendor and product selection that have an impact on quality.
12.0 COMPLAINTS
12.1 Overview
The laboratory considers an effective client complaint handling processes to be of significant
business and strategic value. Listening to and documenting client concerns captures client
knowledge that enables our operations to continually improve processes and client satisfaction.
An effective client complaint handling process also provides assurance to the data user that the
laboratory will stand behind its data, service obligations and products.
A client complaint is any expression of dissatisfaction with any aspect of our business services
(e.g., communications, responsiveness, data, reports, invoicing and other functions) expressed
by any party, whether received verbally or in written form. Client inquiries, complaints or noted
discrepancies are documented, communicated to management, and addressed promptly and
thoroughly.
The laboratory has procedures for addressing both external and internal complaints with the
goal of providing satisfactory resolution to complaints in a timely and professional manner.
The nature of the complaint is identified, documented and investigated, and an appropriate
action is determined and taken. In cases where a client complaint indicates that an established
policy or procedure was not followed, the QA Department must evaluate whether a special audit
must be conducted to assist in resolving the issue. A written confirmation or letter to the client,
outlining the issue and response taken is recommended as part of the overall action taken.
The process of complaint resolution and documentation utilizes the procedures outlined in
Section 12 (Corrective Actions) and is documented following EM-CS-S-1709, Resolving Client
Concerns and Soliciting Client Feedback, and/or EM-QA-S-3553, Root Cause and Corrective
Actions, as applicable.
12.2 External Complaints
An employee that receives a complaint initiates the complaint resolution process by first
documenting the complaint according to (EM-CS-S-1709).
Complaints fall into two categories: correctable and non-correctable. An example of a
correctable complaint would be one where a report re-issue would resolve the complaint. An
example of a non-correctable complaint would be one where a client complains that their data
was repeatedly late. Non-correctable complaints should be reviewed for preventive action
measures to reduce the likelihood of future occurrence and mitigation of client impact.
The general steps in the complaint handling process are:
Receiving and documenting complaints
Acknowledging receipt of complaint, whenever possible
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Complaint investigation and service recovery
Process improvement
The laboratory shall inform the initiator of the complaint of the results of the investigation and
the corrective action taken, if any.
12.3 Internal Complaints
Internal complaints include, but are not limited to: errors and non-conformances, training issues,
internal audit findings, and deviations from methods. Corrective actions may be initiated by any
staff member who observes a nonconformance and shall follow the procedures outlined in
Section 12. In addition, Executive Management, Sales and Marketing and IT may initiate a
complaint by contacting the laboratory or through the corrective action system described in
Section 14.
12.4 Management Review
The number and nature of client complaints is reported by the QA Manager to the Laboratory
Director and Quality Director in the QA Monthly report. Monitoring and addressing the overall
level and nature of client complaints and the effectiveness of the solutions is part of the Annual
Management Systems Review (Section 18).
13.0 CONTROL OF NON-CONFORMING WORK
13.1 Overview
When data discrepancies are discovered or deviations and departures from laboratory SOPs,
policies and/or client requests have occurred, corrective action is taken immediately. First, the
laboratory evaluates the significance of the nonconforming work. Then, a corrective action plan is
initiated based on the outcome of the evaluation. If it is determined that the nonconforming work is
an isolated incident, the plan could be as simple as adding a qualifier / report comment to the final
results and/or making a notation in the project log. If it is determined that the nonconforming work
is a systematic or improper practices issue, the corrective action plan could include a more in depth
investigation and a possible suspension of an analytical method. In all cases, the actions taken are
documented using the laboratory’s corrective action system (refer to Section 12).
Due to the frequently unique nature of environmental samples, sometimes departures from
documented policies and procedures are needed. When an analyst encounters such a situation,
the problem is presented to the supervisor for resolution. (this may be done via LabServe task
system.) The supervisor may elect to discuss it with the Technical Manager or have a
representative contact the client to decide on a logical course of action. Once an approach is
agreed upon, it must be documented via the LabServe project task system. This information can
then be supplied to the client in the form of a report comment, where applicable.
Project Management may encounter situations where a client may request that a special
procedure be applied to a sample that is not standard lab practice. Based on a technical
evaluation, the lab may accept or opt to reject the request based on technical or ethical merit.
An example might be the need to report an analyte that the lab does not normally report. The
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lab would not have validated the method for this compound following the procedures in Section
19. The client may request that the compound be reported based only on the calibration. Such a
request would need to be approved by the QA Manager and the Cluster Leader, documented
and included in the project record. Deviations must also be noted on the final report with a
statement that the analyte is not reported in compliance with the analytical method requirements
and the reason. Data being reported to a non-TNI state would need to note the change made to
how the method is normally run.
13.2 Responsibilities and Authorities
Under certain circumstances, the Cluster Leader, a Technical Manager, or a member of the QA
team may authorize departures from documented procedures or policies. The departures may
be a result of procedural changes due to the nature of the sample; a one-time procedure for a
client; QC failures with insufficient sample to reanalyze, etc. In most cases, the client will be
informed of the departure prior to the reporting of the data. Any departures must be well
documented using the laboratory’s corrective action procedures. This information may also be
documented in logbooks and/or data review checklists as appropriate. Any impacted data must
be referenced in a case narrative and/or flagged with an appropriate data qualifier.
Any misrepresentation or possible misrepresentation of analytical data discovered by any
laboratory staff member must be reported to facility Senior Management within 24-hours. The
Senior Management staff is comprised of the Business Unit Manager,Cluster Leader, the QA
Manager, and the Facility/Technical Managers. The reporting of issues involving alleged
violations of the company’s Data Integrity or Manual Integration procedures must be conveyed
to an ECO (e.g., the VP-QA/EHS) and the laboratory’s Quality Manager within 24 hours of
discovery.
Whether an inaccurate result was reported due to calculation or quantitation errors, data entry
errors, improper practices, or failure to follow SOPs, the data must be evaluated to determine
the possible effect.
The Business Unit Manager, Cluster Leader, QA Manager, ECOs, VP of Operations and the
Quality Directors have the authority and responsibility to halt work, withhold final reports, or
suspend an analysis for due cause as well as authorize the resumption of work.
13.3 Evaluation of Significance and Actions Taken
For each nonconforming issue reported, an evaluation of its significance and the level of
management involvement needed is made. This includes reviewing its impact on the final data,
whether or not it is an isolated or systematic issue, and how it relates to any special client
requirements.
The NDSC Document entitled Data Recalls (CW-Q-S-005) is the procedure to be followed when
it is discovered that erroneous or biased data may have been reported to clients or regulatory
agencies.
The NDSC Document entitled Internal Investigations (CW-L-S-002) is the procedure to be
followed for investigation and correction of situations involved alleged incidents of misconduct or
violation of the company’s ethics policy.
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Laboratory level decisions are documented and approved using the laboratory’s standard
nonconformance/corrective action reporting in lieu of the data recall determination form
contained in NDSC Document No. CW-Q-S-005.
13.4 Prevention of Nonconforming Work
If it is determined that the nonconforming work could recur, further corrective actions must be
made following the laboratory’s corrective action system. Periodically as defined by the
laboratory’s preventive action schedule, the QA Department evaluates non-conformances to
determine if any nonconforming work has been repeated multiple times. If so, the laboratory’s
corrective action process may be followed.
13.5 Method Suspension / Restriction (Stop Work Procedures)
In some cases, it may be necessary to suspend/restrict the use of a method or target analyte
which constitutes significant risk and/or liability to the laboratory. Suspension/restriction
procedures can be initiated by any of the persons noted in Section 13.2, Paragraph 5.
Prior to suspension/restriction, confidentiality will be respected, and the problem with the
required corrective and preventive action will be stated in writing and presented to the Cluster
Leader.
The Cluster Leader shall arrange for the appropriate personnel to meet with the QA Manager as
needed. This meeting shall be held to confirm that there is a problem, that
suspension/restriction of the method is required and will be concluded with a discussion of the
steps necessary to bring the method/target or test fully back on line. In some cases, that may
not be necessary if all appropriate personnel have already agreed there is a problem and there
is agreement on the steps needed to bring the method, target or test fully back on line. The QA
Manager will also initiate a corrective action report as described in Section 12 if one has not
already been started. A copy of any meeting notes and agreed upon steps should be e-mailed
by the laboratory to their Business Unit President, Business Unit Manager, and VP-QA & EHS .
This e-mail acts as notification of the incident.
After suspension/restriction, the lab will hold all reports to clients pending review. No faxing,
mailing or distributing through electronic means may occur. The report must not be posted for
viewing on the internet. It is the responsibility of the Laboratory Director to hold all reporting and
to notify all relevant laboratory personnel regarding the suspension/restriction (e.g., Project
Management, Log-in, etc.). Clients will NOT generally be notified at this time. Analysis may
proceed in some instances depending on the non-conformance issue.
Within 72 hours, the QA Manager will determine if compliance is now met and reports can be
released, OR determine the plan of action to bring work into compliance, and release work. A
team, with all principals involved (e.g., Cluster Leader, Facility/Technical Manager, QA Manager)
can devise a start-up plan to cover all steps from client notification through compliance and
release of reports. Project Management and the Directors of Client Services and Sales and
Marketing must be notified if clients must be notified or if the suspension/restriction affects the
laboratory’s ability to accept work. The QA Manager must approve start-up or elimination of any
restrictions after all corrective action is complete.
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14.0 CORRECTIVE ACTION
14.1 Overview
A major component of the laboratory’s Quality Assurance (QA) Program is the problem
investigation and feedback mechanism designed to keep the laboratory staff informed on quality
related issues and to provide insight to problem resolution. When nonconforming work or
departures from policies and procedures in the quality system or technical operations are
identified, the corrective action procedure provides a systematic approach to assess the issues,
restore the laboratory’s system integrity, and prevent reoccurrence. Eurofins EMLab P&K
employs two systems to manage non-conformances. Issues suspected of being systematic in
nature and for which root cause analysis and a formal Corrective Action Report (CAR) are
documented in the Incident Corrective Action Tracking (ICAT) database. Routine batch non-
conformances, events that are understood to be isolated in nature, are documented in the
LabServe task system.
14.2 General
Problems within the quality system or within analytical operations may be discovered in a variety
of ways, such as QC sample failures, internal or external audits, proficiency testing (PT)
performance, client complaints, staff observation, etc.
The purpose of a corrective action system is to:
Identify non-conformance events and assign responsibility for investigating.
Resolve non-conformance events and assign responsibility for any required corrective
action.
Identify systematic problems before they become serious.
Identify and track client complaints and provide resolution.
14.2.1 LabServe Task System - is used to document the following types of corrective actions:
Deviations from an established procedure or SOP
QC outside of limits
Isolated reporting / calculation errors
Client complaints
14.2.2 Corrective Actions Documented In the ICAT Database
Internal and external audit findings
Failed or unacceptable PT results
Identified poor process or method performance trends
Issues found while reviewing tasks that warrant further investigation
Systematic reporting / calculation errors
Data recall investigations
Questionable trends that are found in the review of NCMs.
Client complaints
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Excessive revised reports
Health and Safety violations
The ICAT database is used to document background information, track the results of corrective
action investigations and root cause analysis, and to provide reports of corrective action plans.
14.3 Closed Loop Corrective Action Process
Any employee in the company can initiate a corrective action. There are four main components to
a closed-loop corrective action process once an issue has been identified: Cause Analysis,
Selection and Implementation of Corrective Actions (both short and long term), Monitoring of the
Corrective Actions, and Follow-up.
14.3.1 Cause Analysis
Upon discovery of a non-conformance event, the event must be defined and documented. A
LabServe task or entry into the ICAT system must be initiated, someone is assigned to
investigate the issue and the event is investigated for cause. Table 12-1 provides some
general guidelines on determining responsibility for assessment.
The cause analysis step is the key to the process as a long term corrective action cannot be
determined until the cause is determined.
If the cause is not readily obvious, the Technical Manager, Laboratory Director, or QA
Manager (or QA designee) is consulted.
14.3.2 Selection and Implementation of Corrective Actions
Where corrective action is needed, the laboratory shall identify potential corrective actions.
The action(s) most likely to eliminate the problem and prevent recurrence are selected and
implemented. Responsibility for implementation is assigned.
The laboratory must additionally consider potential risks and opportunities in the
development and implementation of corrective actions. Where any identified risk and/or
opportunity needs to be updated as a result of a nonconformity, this shall be performed and
documented during the planning of the corrective action.
Corrective actions shall be to a degree appropriate to the magnitude of the problem
identified through the cause analysis.
Whatever corrective action is determined to be appropriate, the laboratory shall document
and implement the changes. This documentation may be recorded within the context of the
originating nonconformity and using the applicable tool (QA-zilla, iCat, LabServe task, etc.)
14.3.3 Root Cause Analysis
Root Cause Analysis is a class of problem solving (investigative) methods aimed at identifying
the basic or causal factor(s) that underlie variation in performance or the occurrence of a
significant failure. The root cause may be buried under seemingly innocuous events, many
steps preceding the perceived failure. At first glance, the immediate response is typically
directed at a symptom and not the cause. Typically, root cause analysis would be best with
three or more incidents to triangulate a weakness. NDSC Document Root Cause Analysis
(No. CA-Q-S-009) provides guidance on this, as well as Eurofins EMLab P&K SOP, Conducting
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Root Cause Investigations and Implementing Corrective Actions,(Document EM-QA-S-
3553)describe the procedure.
Systematically analyze and document the root causes of the more significant problems that are
reported. Identify, track, and implement the corrective actions required to reduce the likelihood
of recurrence of significant incidents. Trend the root cause data from these incidents to identify
root causes that, when corrected, can lead to dramatic improvements in performance by
eliminating entire classes of problems.
Identify the one event associated with problem and ask why this event occurred. Brainstorm
the root causes of failures; for example, by asking why events occurred or conditions existed;
and then why the cause occurred consecutive times until you get to the root cause. For each of
these sub events or causes, ask why it occurred. Repeat the process for the other events
associated with the incident.
Root cause analysis does not mean the investigation is over. Look at technique or other
systems outside the normal indicators. Often creative thinking will find root causes that
ordinarily would be missed and continue to plague the laboratory or operation.
14.3.4 Monitoring of the Corrective Actions
The Cluster Leader, Facility Manager and/or Technical Manager and QA Manager are
responsible to ensure that the corrective action taken was effective.
Ineffective actions are documented and re-evaluated until acceptable resolution is achieved.
Technical Managers are accountable to the Laboratory Director to ensure final acceptable
resolution is achieved and documented appropriately.
The QA Manager reviews monthly ICAT records for trends. Highlights are included in the QA
monthly report (refer to Section 18). If a significant trend develops that adversely affects
quality, an audit of the area is performed and corrective action implemented.
Any out-of-control situations that are not addressed acceptably at the laboratory level may be
reported to the NDSC Quality Director by the QA Manager, indicating the nature of the out-of-
control situation and problems encountered in solving the situation.
14.3.5 Follow-up Audits
Follow-up audits may be initiated by the QA Manager and shall be performed as soon as
possible when the identification of a nonconformance casts doubt on the laboratory’s
compliance with its own policies and procedures, or on its compliance with state or federal
requirements.
These audits often follow the implementation of the corrective actions to verify effectiveness.
An additional audit would only be necessary when a critical issue or risk to business is
discovered.
(Also refer to Section 17.1.4, Special Audits.)
14.4 Technical Corrective Actions
In addition to providing acceptance criteria and specific protocols for technical corrective actions
in the method SOPs, the laboratory has general procedures to be followed to determine when
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departures from the documented policies and procedures and quality control have occurred
(refer to Section 13). The documentation of these procedures is through the use of a LabServe
task or record in the ICAT system.
Table 14-1 includes examples of general technical corrective actions. For specific criteria and
corrective actions, refer to the analytical methods or specific method SOPs. The laboratory may
also maintain Work Instructions on these items that are available upon request.
Table 14-1 provides some general guidelines for identifying the individual(s) responsible for
assessing each QC type and initiating corrective action. The table also provides general
guidance on how a data set should be treated if associated QC measurements are
unacceptable. Specific procedures are included in Method SOPs, Work Instructions, QAM
Sections 19 and 20. All corrective actions are reviewed monthly, at a minimum, by the QA
Manager and highlights are included in the QA monthly report.
To the extent possible, samples shall be reported only if all quality control measures are
acceptable. If the non-conformance does not impair the usability of the results, data will be
reported with an appropriate data qualifier. Where sample results may be impaired, the Project
Manager is notified by a LabServe task and appropriate corrective action (e.g., reanalysis) is taken
and documented.
14.5 Basic Corrections
When mistakes occur in records, each mistake shall be crossed-out, [not obliterated (e.g. no
white-out)], and the correct value entered alongside. All such corrections shall be initialed (or
signed) and dated by the person making the correction. In the case of records stored
electronically, the original uncorrected file must be maintained intact and a second corrected file
is created. This same process applies to adding additional information to a record. All additions
made later than the initial must also be initialed (or signed) and dated. When corrections are
due to reasons other than obvious transcription errors, the reason for the corrections (or
additions) shall also be documented.
Table 14-1. Example – General Corrective Action Procedures
QC Activity
(Individual
Responsible for
Initiation/Assessment
)
Acceptance Criteria Recommended
Corrective Action
Initial Instrument
Blank
(Analyst)
- Instrument response < MDL.- Prepare another blank.
- If same response, determine cause of
contamination: reagents, environment,
instrument equipment failure, etc..
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QC Activity
(Individual
Responsible for
Initiation/Assessment
)
Acceptance Criteria Recommended
Corrective Action
Initial Calibration
Standards
(Analyst, Technical
Manager(s))
- Correlation coefficient >
0.99 or standard
concentration value.
- % Recovery within
acceptance range.
- See details in Method SOP.
- Reanalyze standards.
- If still unacceptable, remake standards and
recalibrate instrument.
Independent Calibration
Verification
(Second Source)
(Analyst, Technical
Manager(s))
- % Recovery within control
limits.
- Remake and reanalyze standard.
- If still unacceptable, then remake calibration
standards or use new primary standards and
recalibrate instrument.
Continuing Calibration
Standards
(Analyst, Data
Reviewer)
% Recovery within control
limits.
- Reanalyze standard.
- If still unacceptable, then recalibrate and
rerun affected samples.
Matrix Spike /
Matrix Spike Duplicate
(MS/MSD)
(Analyst, Data
Reviewer)
- % Recovery within limits
documented in (state where
limits are maintained).
- If the acceptance criteria for duplicates or
matrix spikes are not met because of matrix
interferences, the acceptance of the analytical
batch is determined by the validity of the LCS.
- If the LCS is within acceptable limits the
batch is acceptable.
- The results of the duplicates, matrix spikes
and the LCS are reported with the data set.
- For matrix spike or duplicate results outside
criteria the data for that sample shall be
reported with qualifiers.
Laboratory Control
Sample (LCS)
(Analyst, Data
Reviewer)
- % Recovery within limits
specified in (state where
limits are maintained).
- Batch must be re-prepared and re-analyzed.
This includes any allowable marginal
exceedance.
When not using marginal exceedances, the
following exceptions apply:
1) when the acceptance criteria for the positive
control are exceeded high (i.e., high bias) and
there are associated samples that are non-
detects, then those non-detects may be
reported with data qualifying codes;
2) when the acceptance criteria for the positive
control are exceeded low (i.e., low bias), those
sample results may be reported if they exceed
a maximum regulatory limit/decision level with
data qualifying codes.
Note: If there is insufficient sample or the
holding time cannot be met, contact client and
report with flags.
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QC Activity
(Individual
Responsible for
Initiation/Assessment
)
Acceptance Criteria Recommended
Corrective Action
Method Blank (MB)
(Analyst, Data
Reviewer)
< Reporting Limit - Reanalyze blank.
- If still positive, determine source of
contamination. If necessary, reprocess (i.e.
digest or extract) entire sample batch. Report
blank results.
- Qualify the result(s) if the concentration of a
targeted analyte in the MB is at or above the
reporting limit AND is > 1/10 of the amount
measured in the sample.
Proficiency Testing (PT)
Samples
(QA Manager,
Technical Manager(s))
- Criteria supplied by PT
Supplier.
- Any failures or warnings must be investigated
for cause. Failures may result in the need to
repeat a PT sample to show the problem is
corrected.
Daily References
(QA Manager(s),
Analysts)
SOP EM-QA-S-1194, Quality
Control for Sample Analysis
SOP EM-QA-S-1259, Quality
Control for Asbestos Analysis
Reference EM-QA-R-5730,
Quality Control Criteria
Summary
- Any failures or warnings must be investigated
for cause. Failures may result in the need to
repeat sample analysis to show the problem is
corrected.
Duplicate Samples
(QA Manager(s),
Analysts)
SOP EM-QA-S-1194, Quality
Control for Sample Analysis
SOP EM-QA-S-1259, Quality
Control for Asbestos Analysis
Reference EM-QA-R-5730,
Quality Control Criteria
Summary
- Any failures or warnings must be investigated
for cause. Failures may result in the need to
repeat sample analysis to show the problem is
corrected.
Replicate Samples
(QA Manager(s),
Analysts)
SOP EM-QA-S-1194, Quality
Control for Sample Analysis
SOP EM-QA-S-1259, Quality
Control for Asbestos Analysis
Reference EM-QA-R-5730,
Quality Control Criteria
Summary
- Any failures or warnings must be investigated
for cause. Failures may result in the need to
repeat sample analysis to show the problem is
corrected.
Internal / External
Audits
(QA Manager,
Technical Manager(s),
Laboratory Director)
- Defined in Quality System
documentation such as
SOPs, QAM, etc..
- Non-conformances must be investigated
through CAR system and necessary
corrections must be made.
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QC Activity
(Individual
Responsible for
Initiation/Assessment
)
Acceptance Criteria Recommended
Corrective Action
Reporting / Calculation
Errors
(Depends on issue –
possible individuals
include: Analysts, Data
Reviewers, Project
Managers, Technical
Managers, QA
Manager, Corporate
QA, Corporate
Management)
- NDSC Document No. CW-
Q-S-005, Data Recall
- Corrective action is determined by type of
error. Follow the procedures in NDSC
Document No. CW-L-S-002 or EM-QA-S-
3533.
Client Complaints
(Project Managers, Lab
Director/Manager,
Sales and Marketing)
- - Corrective action is determined by the type of
complaint. For example, a complaint regarding
an incorrect address on a report will result in
the report being corrected and then follow-up
must be performed on the reasons the
address was incorrect (e.g., database needs
to be updated).
QA Monthly Report
(Refer to Section 16 for
an example)
(QA Manager, Lab
Director/Manager,
Technical Manager(s))
- QAM, SOPs.- Corrective action is determined by the type of
issue. For example, CARs for the month are
reviewed and possible trends are investigated.
Health and Safety
Violation
(Safety Officer, Lab
Director/Manager,
Technical Manager(s))
- Environmental Health and
Safety (EHS) Manual.
- Non-conformance is investigated and
corrected through CAR system.
15.0 PREVENTIVE ACTION / IMPROVEMENT
15.1 Overview
The laboratory’s preventive action programs improve or eliminate potential causes of
nonconforming product and/or nonconformance to the quality system. This preventive action
process is a proactive and continuous process of improvement activities that can be initiated
through feedback from clients, employees, business providers, and affiliates. The QA
Department has the overall responsibility to ensure that the preventive action process is in
place, and that relevant information on actions is submitted for management review. (EM-QA-S-
7577, Continuous Improvement and Preventive Actions.)
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Dedicating resources to an effective preventive action system emphasizes the laboratory’s
commitment to its QA Program. It is beneficial to identify and address negative trends before
they develop into complaints, problems and corrective actions. Additionally, the laboratory
continually strives to improve customer service and client satisfaction through continuous
improvements to laboratory systems.
Opportunities for improvement may be discovered through any of the following:
review of the monthly QA Metrics Report,
trending Labserve tasks or iCAT corrective actions,
review of control charts and QC results,
trending proficiency testing (PT) results,
performance of management system reviews,
trending client complaints,
review of processing operations, or
staff observations.
The monthly Management Systems Metrics Report shows performance indicators in all areas of
the laboratory and quality system. These areas include revised reports, corrective actions, audit
findings, internal auditing and data authenticity audits, client complaints, PT samples, holding
time violations, SOPs, ethics training, etc. The metrics report is reviewed monthly by the
laboratory management, NDSC QA Team, Local and Executive Management. These metrics
are used in evaluating the management and quality system performance on an ongoing basis
and provide a tool for identifying areas for improvement.
Items identified as continuous improvement opportunities to the management system may be
issued as goals from the annual management systems review, recommendations from internal
audits, white papers, Lessons Learned, Technical Services audit report, Technical Best
Practices, or as Executive or management initiatives.
The laboratory’s corrective action process is integral to implementation of preventive actions. A
critical piece of the corrective action process is the implementation of actions to prevent further
occurrence of a non-compliance event. Historical review of corrective action and non-
conformances provides a valuable mechanism for identifying preventive action opportunities.
15.1.1 The following elements are part of a preventive action/process improvement system:
Identification of an opportunity for preventive action or process improvement.
Process for the preventive action or improvement.
Define the measurements of the effectiveness of the process once undertaken.
Execution of the preventive action or improvement.
Evaluation of the plan using the defined measurements.
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Verification of the effectiveness of the preventive action or improvement.
Close-Out by documenting any permanent changes to the Quality System as a result of the
Preventive Action or Process Improvement. Documentation of Preventive Action/process
Improvement is incorporated into the monthly QA reports, corrective action process and
management review.
15.1.2 Any preventive actions/process improvement undertaken or attempted shall be taken
into account during the annual Management Systems Review (Section 16). A highly detailed
report is not required; however, a summary of successes and failures within the preventive
action program is sufficient to provide management with a measurement for evaluation.
16.0 CONTROL OF RECORDS
The laboratory maintains a records management system appropriate to its needs and that
complies with applicable standards or regulations as required. The system produces
unequivocal, accurate records that document all laboratory activities. The laboratory retains all
original observations, calculations and derived data, calibration records and a copy of the
analytical report for a minimum of five years after it has been issued. Exceptions for programs
with longer retention requirements are discussed in Section 14.1.2.
16.1 Overview
The laboratory has established procedures for identification, collection, indexing, access, filing,
storage, maintenance and disposal of quality and technical records. A record index is listed in
Table 16-1. More detailed information on retention of specific records is provided in EM-QA-S-
2059, Document Control and Control of Records. Quality records are maintained by the QA
department in a database, which is backed up as part of the regular laboratory backup.
Records are of two types; either electronic or hard copy paper formats depending on whether
the record is computer or hand generated (some records may be in both formats). Technical
records are maintained by local facility management. Laboratory technical records are
maintained by IT.
Table 16-1. Record Index1
Record Types 1 :Retention Time:
Technical
Records
- Raw Data
- Logbooks2
- Standards
- Certificates
- Analytical Records
- MDLs/IDLs/DOCs
- Lab Reports
5 Years from analytical report issue*
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Record Types 1 :Retention Time:
Official
Documents
- Quality Assurance Manual (QAM)
- Work Instructions
- Policies
- SOPs
- Policy Memorandums
- Manuals
- Published Methods
Indefinitely
QA Records -Certifications
-Method and Software Validation /
Verification Data
Indefinitely
QA Records - Internal & External Audits/Responses
- Corrective/Preventive Actions
- Management Reviews
- Data Investigation
5 Years from archival*
Data Investigation: 5 years or the life of the
affected raw data storage whichever is
greater (beyond 5 years if ongoing project or
pending investigation)
Project
Records
- Sample Receipt & COC Documents
- Contracts and Amendments
- Correspondence
- QAPP
- SAP
- Telephone Logbooks
- Lab Reports
5 Years from analytical report issue*
Administrative
Records
Financial and Business Operations Refer to NDSC Document No. CW-L-WI-001
EH&S Manual, Permits Indefinitely
Disposal Records Indefinitely
Employee Handbook Indefinitely
Personnel files, Employee Signature &
Initials, Administrative Training
Records (e.g., Ethics)
Refer to HR Manual
Administrative Policies Indefinitely
Technical Training Records 7 years
Legal Records Indefinitely
HR Records Refer to NDSC Document No. CW-L-WI-001
IT Records Refer to NDSC Document No. CW-L-WI-001
Corporate Governance Records Refer to NDSC Document No. CW-L-WI-001
Sales & Marketing 5 years
Real Estate Indefinitely
1 Record Types encompass hardcopy and electronic records.
2 Examples of Logbook types: Maintenance, Instrument Run, Preparation (standard and samples),
Standard and Reagent Receipt, Archiving, Balance Calibration, Temperature (hardcopy or electronic
records).
* Exceptions listed in Table 14-2.
16.1.1 All records are stored and retained in such a way that they are secure and readily
retrievable at the laboratory facility or main regional facility that provides a suitable environment
to prevent damage or deterioration and to prevent loss. All records shall be protected against
fire, theft, loss, environmental deterioration, and vermin. In the case of electronic records,
electronic or magnetic sources, storage media are protected from deterioration caused by
magnetic fields and/or electronic deterioration.
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Access to the data is limited to laboratory and company employees and shall be documented
with an access log. Records archived off-site are stored in a secure location where a record is
maintained of any entry into the storage facility. Whether on-site or off-site storage is used, logs
are maintained in each storage box to note removal and return of records. Retention of records
are maintained on-site at the laboratory for at least 1 month after their generation and moved
offsite for the remainder of the required storage time. Records are maintained for a minimum of
five years unless otherwise specified by a client or regulatory requirement.
For raw data and project records, record retention shall be calculated from the date the project
report is issued. For other records, such as NDSC and or KGD, Controlled Documents, QA, or
Administrative Records, the retention time is calculated from the date the record is formally
retired. Records related to the programs listed in Table 16-2 have lengthier retention
requirements and are subject to the requirements in Section 16.1.3.
16.2 Programs with Longer Retention Requirements
Some regulatory programs have longer record retention requirements than the standard record
retention time. These are detailed in Table 16-2 with their retention requirements. In these
cases, the longer retention requirement is enacted. If special instructions exist such that client
data cannot be destroyed prior to notification of the client, the container or box containing that
data is marked as to who to contact for authorization prior to destroying the data.
Table 16-2.Example: Special Record Retention Requirements
Program 1Retention Requirement
Drinking Water – All States 10 years (lab reports and raw data)
AIHA-LAP ELLAP (Lead)5 years (project records) (quality control
laboratory records required to support retained
data and associated reporting for AIHA-LAP
ELLAP (lead) will be maintained for a minimum
of 6 years)
NYS DOH 5 years (quality control laboratory records
required to support retained data and associated
reporting for NYS DOH will be maintained for a
minimum of 6 years)
OSHA 30 years
1Note: Extended retention requirements must be noted with the archive documents or addressed in
facility-specific records retention procedures.
16.2.1 The laboratory has procedures to protect and back-up records stored electronically and
to prevent unauthorized access to or amendment of these records. All analytical data is
maintained as hard copy or in a secure readable electronic format. For analytical reports that
are maintained as copies in PDF format, refer to Section 19.13.1 for more information.
16.2.2 The record keeping system allows for historical reconstruction of all laboratory activities
that produced the analytical data, as well as rapid recovery of historical data (Records stored off
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site should be accessible within 2 days of a request for such records). The history of the sample
from when the laboratory took possession of the samples must be readily understood through
the documentation. This shall include inter-laboratory transfers of samples.
The records include the identity of personnel involved in sampling, sample receipt,
preparation, or testing. All analytical work contains the initials (at least) of the personnel
involved. The laboratory’s copy of the COC is stored in chronological order. The chain of
custody would indicate the name of the sampler. If any sampling notes are provided with a
work order, they are kept with this package.
All information relating to the laboratory facilities’ equipment, analytical test methods, and
related laboratory activities, such as sample receipt, sample preparation, or data verification
are documented.
The record keeping system facilitates the retrieval of all working files and archived records
for inspection and verification purposes (e.g., set format for naming electronic files, set
format for what is included with a given analytical data set. Instrument data is stored
sequentially by instrument. A given day’s analyses are maintained in the order of the
analysis. Run logs are maintained for each instrument or method; a copy of each day’s run
log or instrument sequence is stored with the data to aid in re-constructing an analytical
sequence. Where an analysis is performed without an instrument, bound logbooks or bench
sheets are used to record and file data, where applicable and not part of LabServe direct
entry. Standard and reagent information is recorded in logbooks or entered into LabServe
for each method as required.
Changes to hardcopy records shall follow the procedures outlined in Section 12 and 19.
Changes to electronic records in LabServe or instrument data are recorded in audit trails.
The reason for a signature or initials on a document is clearly indicated in the records such
as “sampled by,” “prepared by,” “reviewed by”, or “analyzed by”.
All generated data except those that are generated by automated data collection systems,
are recorded directly, promptly and legibly in permanent dark ink.
Hard copy data may be scanned into PDF format for record storage as long as the scanning
process can be verified in order to ensure that no data is lost and the data files and storage
media must be tested to verify the laboratory’s ability to retrieve the information prior to the
destruction of the hard copy that was scanned.
Also refer to Section 19.13.1 ‘Computer and Electronic Data Related Requirements’.
16.3 Technical and Analytical Records
16.3.1 The laboratory retains records of original observations, derived data and sufficient
information to establish an audit trail, calibration records, staff records and a copy of each
analytical report issued, for a minimum of five years unless otherwise specified by a client or
regulatory requirement. The records for each analysis shall contain sufficient information to
enable the analysis to be repeated under conditions as close as possible to the original. The
records shall include the identity of laboratory personnel responsible for the subsampling,
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performance of each analysis and reviewing results.
16.3.2 Observations, data and calculations are recorded real-time and are identifiable to the
specific task.
16.3.3 Changes to hardcopy records shall follow the procedures outlined in Section 12 and 19.
Changes to electronic records in LabServe or instrument data are recorded in audit trails.
The essential information to be associated with analysis, such as strip charts, tabular printouts,
computer data files, analytical notebooks, and run logs, include:

laboratory sample ID code;
Date of analysis; time of analysis is also required if the holding time is seventy-two (72)
hours or less, or when time critical steps are included in the analysis (e.g., drying times,
incubations, etc.); instrumental analyses have the date and time of analysis recorded as part
of their general operations. Where a time critical step exists in an analysis, location for such
a time is included as part of the documentation in a specific logbook or on a benchsheet.
Instrumentation identification and instrument operating conditions/parameters. Operating
conditions/parameters are typically recorded in instrument maintenance logs where
available.
analysis type;
all manual calculations and manual integrations;
analyst's or operator's initials/signature;
sample preparation including cleanup, sample processing/dilution/plating, incubation periods
or subculture, ID codes, volumes, weights, instrument printouts, meter readings,
calculations, reagents;
test results;
standard and reagent origin, receipt, preparation, and use;
calibration criteria, frequency and acceptance criteria;
data and statistical calculations, review, confirmation, interpretation, assessment and
reporting conventions;
quality control protocols and assessment;
electronic data security, software documentation and verification, software and hardware
audits, backups, and records of any changes to automated data entries; and
Method performance criteria including expected quality control requirements. These are
indicated both in LabServe and on specific analytical report formats.
16.3.4 All logbooks used during receipt, preparation, storage, analysis, and reporting of
samples or monitoring of support equipment shall undergo a periodic, documented supervisory
or peer review.
16.4 Laboratory Support Activities
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In addition to documenting all the above-mentioned activities, the following are retained QA
records and project records (previous discussions in this section relate where and how these
data are stored):
all original raw data, whether hard copy or electronic, for calibrations, samples and quality
control measures, including analysts’ work sheets and data output records (chromatograms,
strip charts, and other instrument response readout records);
a written description or reference to the specific test method used which includes a
description of the specific computational steps used to translate parametric observations
into a reportable analytical value;
copies of final reports;
archived SOPs;
correspondence relating to laboratory activities for a specific project;
all corrective action reports, audits and audit responses;
proficiency test results and raw data; and
results of data review, verification, and crosschecking procedures
16.4.1 Sample Handling Records
Records of all procedures to which a sample is subjected while in the possession of the
laboratory are maintained. These include but are not limited to records pertaining to:
sample preservation including appropriateness of sample container and compliance with
holding time requirement;
sample identification, receipt, acceptance or rejection and login;
sample storage and tracking including shipping receipts, sample transmittal / COC forms;
and
procedures for the receipt and retention of samples, including all provisions necessary to
protect the integrity of samples.
16.5 Administrative Records
The laboratory also maintains the administrative records in either electronic or hard copy form.
Refer to Table 14-1.
16.6 Records Management, Storage and Disposal
All records (including those pertaining to test equipment), certificates and reports are safely
stored, held secure and in confidence to the client. Certification related records are available
upon request.
All information necessary for the historical reconstruction of data is maintained by the laboratory.
Records that are stored only on electronic media must be supported by the hardware and
software necessary for their retrieval.
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Records that are stored or generated by computers or personal computers have hard copy,
write-protected backup copies, or an electronic audit trail controlling access.
The laboratory has a record management system (a.k.a., document control) for control of
laboratory notebooks, instrument logbooks, standards logbooks, and records for data reduction,
validation, storage and reporting. Records are considered archived when noted as such in the
records management system (a.k.a., document control.)
16.6.1 Transfer of Ownership
In the event that the laboratory transfers ownership or goes out of business, the laboratory shall
ensure that the records are maintained or transferred according to client’s instructions. Upon
ownership transfer, record retention requirements shall be addressed in the ownership transfer
agreement and the responsibility for maintaining archives is clearly established. In addition, in
cases of bankruptcy, appropriate regulatory and state legal requirements concerning laboratory
records must be followed. In the event of the closure of the laboratory, all records will revert to
the control of the NDSC. Should the entire company cease to exist, as much notice as possible
will be given to clients and the accrediting bodies who have worked with the laboratory during
the previous 5 years of such action.
16.6.2 Records Disposal
Records are removed from the archive and destroyed after 5 years unless otherwise specified
by a client or regulatory requirement. On a project specific or program basis, clients may need
to be notified prior to record destruction. Records are destroyed in a manner that ensures their
confidentiality such as shredding, mutilation or incineration. (Refer to Tables 16-1 and 16-2).
Electronic copies of records must be destroyed by erasure or physically damaging off-line
storage media so no records can be read.
If a third party records management company is hired to dispose of records, a “Certificate of
Destruction” is required.
17.0 AUDITS
17.1 Internal Audits
Internal audits are performed to verify that laboratory operations comply with the requirements
of the lab’s quality system and with the external quality programs under which the laboratory
operates. Audits are planned and organized by the QA staff. Personnel conducting the audits
should be independent of the area being evaluated. Auditors will have sufficient authority,
access to work areas, and organizational freedom necessary to observe all activities affecting
quality and to report the assessments to laboratory management and , when requested, to
Executive management.
Audits are conducted and documented as described in the NDSC Document on performing
Internal Auditing, No. CW-Q-S-003. The types and frequency of routine internal audits are
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described in Table 15-1. Special or ad hoc assessments may be conducted as needed under
the direction of the QA staff.
Table 17-1. Types of Internal Audits and Frequency
Description Performed by Frequency
Quality Systems Audits QA Department, QA
approved designee, or
NDSC QA
All areas of the laboratory annually
Method Audits
QA Technical Audits
Joint responsibility:
a)QA Manager or
designee
b)Technical Manager or
Designee
(Refer to NDSC Document
No. CW-Q-S-003)
QA Technical Audits Frequency:
50% of methods annually
SOP Method Compliance Joint responsibility:
a) QA Manager or designee
b) Technical Manager or
Designee
(Refer to CW-Q-S-003)
SOP Compliance Review Frequency:
Every 2 years
100% of SOPs annually (DoD/DOE
Labs)
Special QA Department or
Designee
Surveillance or spot checks performed as
needed, e.g., to confirm corrective actions
from other audits.
Performance Testing Analysts with QA oversight Two successful per year for each TNI field
of testing or as dictated by regulatory
requirements
17.1.1 Annual Quality Systems Audit
An annual quality systems audit is required to ensure compliance to analytical methods and
SOPs, Eurofins Data Integrity and Ethics Policies (See Section 7.2), TNI quality systems, AIHA-
LA LLC quality systems, NIST NVLAP quality systems, client and state requirements, and the
effectiveness of the internal controls of the analytical process, including but not limited to data
review, quality controls, preventive action and corrective action. The completeness of earlier
corrective actions is assessed for effectiveness & sustainability. The audit is divided into
sections for each operating or support area of the lab, and each section is comprehensive for a
given area. The area audits may be performed on a rotating schedule throughout the year to
ensure adequate coverage of all areas. This schedule may change as situations in the
laboratory warrant.
17.1.2 QA Technical Audits
QA technical audits assess data authenticity and analyst integrity. These audits are based on
client projects, associated sample delivery groups, and the methods performed. Reported
results are compared to raw data to verify the authenticity of results. The validity of calibrations
and QC results are compared to data qualifiers, footnotes, and report comments. Manual
calculations are checked. QA technical audits will include all methods within a two-year period.
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17.1.3 SOP Method Compliance
Compliance of all SOPs with the source methods and compliance of the operational groups with
the SOPs will be assessed by the Technical Manager or qualified designee at least every two
years.
17.1.4 Special Audits
Special audits are conducted on an as needed basis, generally as a follow up to specific issues
such as client complaints, corrective actions, PT results, data audits, system audits, validation
comments, regulatory audits or suspected ethical improprieties. Special audits are focused on a
specific issue, and report format, distribution, and timeframes are designed to address the
nature of the issue.
17.1.5 Performance Testing
Eurofins EMLab P&K, LLC participates in external proficiency testing programs consistent with
the requirements outlined by the Laboratory’s accreditation, licensing, or registration bodies,
and at the frequency required to remain compliant with such programs. The laboratory generally
participates in the following types of PT studies, where applicable and/or required by external
accreditation, licensing, or registration bodies: AIHA-PAT LLC (EMLAP, IHLAP), NIST NVLAP
Bulk Asbestos, Legionella proficiency testing, potable and non-potable water, etc.
It is Eurofins policy that PT samples be treated as typical samples in the production process.
Furthermore, where PT samples present special or unique problems, in the regular production
process they may need to be treated differently, as would any special or unique request
submitted by any client. The QA Manager must be consulted and in agreement with any
decisions made to treat a PT sample differently due to some special circumstance.
When the analysis includes subjective analyst evaluation (e.g., microscopic identification and/or
quantitation), all analysts, including those in sub-facilities, are required to participate in
proficiency testing, with each analyst separately analyzing, recording, and reporting test results.
All proficiency testing samples are to be analyzed by the receiving facility. Transfer to alternate
laboratory is prohibited, as is discussion of proficiency round details with other facilities prior to
completion of a round. Where a facility employs analysts who perform analyses across more
than one facility, these analysts are restricted to participation in one facility’s proficiency testing,
and any discussion of details with personnel outside of the analyst’s participation location is
strictly prohibited.
Written investigations for unacceptable PT results are required. In some cases it may be
necessary for blind QC samples to be submitted to the laboratory to show a return to control.
17.2 External Audits
External audits are performed when accrediting and/or certifying agencies or clients conduct on-
site inspections or submit performance testing samples for analysis. It is Eurofins policy to
cooperate fully with regulatory authorities and clients. The laboratory makes every effort to
provide the auditors with access to personnel, documentation, and assistance . Laboratory
supervisors are responsible for providing corrective actions to the QA Manager who coordinates
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the response. Audit responses are due in the time allotted by the client or agency performing
the audit.
The laboratory cooperates with clients and their representatives to monitor the laboratory’s
performance in relation to work performed for the client. The client may only view data and
systems related directly to the client’s work. All efforts are made to keep other client information
confidential.
17.2.1 Confidential Business Information (CBI) Considerations
During on-site audits, auditors may come into possession of information claimed as business
confidential. A business confidentiality claim is defined as “a claim or allegation that business
information is entitled to confidential treatment for reasons of business confidentiality or a
request for a determination that such information is entitled to such treatment.” When
information is claimed as business confidential, the laboratory must place on (or attach to) the
information at the time it is submitted to the auditor, a cover sheet, stamped or typed legend or
other suitable form of notice, employing language such as “trade secret”, “proprietary” or
“company confidential”. Confidential portions of documents otherwise non-confidential must be
clearly identified. CBI may be purged of references to client identity by the responsible
laboratory official at the time of removal from the laboratory. However, sample identifiers may
not be obscured from the information. Additional information regarding CBI can be found in
within the 2009 TNI standards.
17.3 Audit Findings
Audit findings are documented using the corrective action process and database (see Section
12). The laboratory’s corrective action responses may include action plans that could not be
completed within a predefined timeframe. In these instances, a completion date must be set and
agreed to by operations management and the QA Manager.
Developing and implementing corrective actions to findings is the responsibility of the Cluster
Leader and/or Facility Manager where the finding originated. Findings that are not corrected by
specified due dates are reported monthly to management in the QA monthly report.
If any audit finding casts doubt on the effectiveness of the operations or on the correctness or
validity of the laboratory’s test results, the laboratory shall take timely corrective action, and
shall notify clients in writing if the investigations show that the laboratory results have been
affected. Once corrective action is implemented, a follow-up audit is scheduled to ensure that the
problem has been corrected.
Clients must be notified promptly in writing of any event such as the identification of defective
measuring or test equipment that casts doubt on the validity of results given in any test report or
amendment to a test report. The investigation must begin within 24 hours of discovery of the
problem and all efforts are made to notify the client within two weeks after the completion of the
investigation.

18.0 MANAGEMENT REVIEWS
18.1 Quality Assurance Report
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The QA Department is responsible for preparing a comprehensive monthly metrics report to
Management to keep them apprised of current quality issues. This report fosters
communication, review, and refinement of the QA system to evaluate the suitability of policies
and procedures to meet both regulatory and laboratory quality objectives.
The NDSC QA team compiles information from all of the Environment Testing laboratories
monthly metrics reports for the Executive Management team. This report includes notable
information and concerns regarding the laboratories QA program and a listing of new
regulations that may potentially impact the laboratories.
18.2 Annual Management Review
The Laboratory Management team (Cluster Leader, Facility Managers/Technical Manager, QA
Manager) conducts a review annually of its quality systems to ensure its continuing suitability
and effectiveness in meeting client and regulatory requirements and to introduce any necessary
changes or improvements. It will also provide a platform for defining goals, objectives and
action items that feed into the laboratory planning system. The LabServe review consists of
examining any audits, complaints or concerns that have been raised through the year that are
related to LabServe. The laboratory will summarize any critical findings that cannot be solved by
the lab and report them to Corporate IT.
This management systems review (NDSC Document No. CW-Q-S-004 and Work Instruction No.
CW-Q-WI-003) uses information generated during the preceding year to assess the “big picture”
by ensuring that routine actions taken and reviewed on a monthly basis are not components of
larger systematic concerns. The monthly review should keep the quality systems current and
effective, therefore, the annual review is a formal senior management process to review specific
existing documentation. Significant issues from the following documentation are compiled or
summarized by the QA Manager prior to the review meeting:
Matters arising from the previous annual review.
Prior Monthly QA Reports issues.
Laboratory QA Metrics.
Review of report reissue requests.
Review of client feedback and complaints.
Issues arising from any prior management or staff meetings.
Minutes from prior senior lab management meetings. Issues that may be raised from these
meetings include:
o Adequacy of staff, equipment and facility resources.
o Adequacy of policies and procedures.
o Future plans for resources and testing capability and capacity.
The annual internal double blind PT program sample performance (if performed),
Compliance to the Ethics Policy and Data Integrity Plan. Including any evidence/incidents of
inappropriate actions or vulnerabilities related to data Integrity.
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Evaluation of overall risk, including risks to impartiality, confidentiality, reporting statements
of conformity, and nonconforming work.
A report is generated by the QA Manager and management. The report is distributed to the
Business Unit Manager, Cluster Leader, Facility/Technical Manager, and QA Manager. The
report includes, but is not limited to:
The date of the review and the names and titles of participants.
A reference to the existing data quality related documents and topics that were reviewed.
Quality system or operational changes or improvements that will be made as a result of the
review [e.g., an implementation schedule including assigned responsibilities for the changes
(Action Table)].
Changes to the quality systems requiring update to the laboratory QA Manual shall be included
in the next revision of the QA Manual.
18.3 Potential Integrity Related Managerial Reviews
Potential integrity issues (data or business related) must be handled and reviewed in a
confidential manner until such time as a follow-up evaluation, full investigation, or other
appropriate actions have been completed and issues clarified. NDSC Internal Investigations
Document shall be followed (NDSC Document No. CW-L-S-002). All investigations that result in
finding of inappropriate activity are documented and include any disciplinary actions involved,
corrective actions taken, and all appropriate notifications of clients.
Eurofins Built Testing President, Business Unit Manager, Cluster Leader, and NDSC Team are
informed of any current data integrity or data recall investigations via the monthly metrics report.
19.0 TEST METHODS AND METHOD VALIDATION
19.1 Overview
The laboratory uses methods that are appropriate to meet our clients’ requirements and that are
within the scope of the laboratory’s capabilities. These include sampling, handling, transport,
storage and preparation of samples, and, where appropriate, an estimation of the measurement
of uncertainty as well as statistical techniques for analysis of environmental data.

Instructions are available in the laboratory for the operation of equipment as well as for the
handling and preparation of samples. All instructions, Standard Operating Procedures (SOPs),
reference methods and manuals relevant to the working of the laboratory are readily available to
all staff. Deviations from published methods are documented (with justification) in the laboratory’s
approved SOPs. SOPs are submitted to clients for review at their request. Significant deviations
from published methods require client approval and regulatory approval where applicable.
19.2 Standard Operating Procedures ( SOPS )
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The laboratory maintains SOPs that accurately reflect all phases of the laboratory such as
assessing data integrity, corrective actions, handling customer complaints as well as all
analytical methods and sampling procedures. Where method SOPs are derived from the most
recently promulgated/approved, published methods and are specifically adapted to the
laboratory facility. Modifications or clarifications to published methods are clearly noted in the
SOPs. All SOPs are controlled in the laboratory.
All SOPs contain a revision number, effective date, and appropriate approval signatures.
Controlled copies are available to all staff.
Procedures for writing an SOP are incorporated by reference to SOP EM-QA-S-2059,
Document Control and Control of Records.
SOPs are reviewed at a minimum of every 2 years (annually for Drinking Water and DoD/DOE
SOPs), and where necessary, revised to ensure continuing suitability and compliance with
applicable requirements.
19.3 Laboratory Methods Manual
For each test method, the laboratory shall have available the published referenced method as
well as the laboratory developed SOP.
Note:If more stringent standards or requirements are included in a mandated test method
or regulation than those specified in this manual, the laboratory shall demonstrate that such
requirements are met. If it is not clear which requirements are more stringent, the standard from
the method or regulation is to be followed. Any exceptions or deviations from the referenced
methods or regulations are noted in the specific analytical SOP.
The laboratory maintains an SOP Index for both technical and non-technical SOPs. Technical
SOPs are maintained to describe a specific test method. Non-technical SOPs are maintained to
describe functions and processes not related to a specific test method.
19.4 Selection of Methods
Since numerous methods and analytical techniques are available, continued communication
between the client and laboratory is imperative to assure the correct methods are utilized. Once
client methodology requirements are established, this and other pertinent information is
summarized by the Project Manager. These mechanisms ensure that the proper analytical
methods are applied when the samples arrive for log-in. For non-routine analytical services
(e.g., special matrices, non-routine compound lists), the method of choice is selected based on
client needs and available technology. The methods selected should be capable of measuring
the specific parameter of interest, in the concentration range of interest, and with the required
precision and accuracy.

19.4.1 Sources of Methods
Routine analytical services are performed using both in-house developed methodology and
standard EPA-approved methodology. In some cases, modification of standard approved
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methods may be necessary to provide accurate analyses of particularly complex matrices.
When the use of specific methods for sample analysis is mandated through project or regulatory
requirements, only those methods shall be used.
When clients do not specify the method to be used or methods are not required, the methods
used will be clearly validated and documented in an SOP and available to clients and/or the end
user of the data. Refer to Appendix 3 for a list of the currently accepted U.S. EPA analytical
method references used by the laboratory.
The laboratory reviews updated versions to all the aforementioned references for adaptation
based upon capabilities, instrumentation, etc., and implements them as appropriate. As such,
the laboratory strives to perform only the latest versions of each approved method as
regulations allow or require.
Other reference procedures for non-routine analyses may include methods established by
specific states (e.g., Underground Storage Tank methods), ASTM or equipment manufacturers.
Sample type, source, and the governing regulatory agency requiring the analysis will determine
the method utilized.
The laboratory shall inform the client when a method proposed by the client may be
inappropriate or out of date. After the client has been informed, and they wish to proceed
contrary to the laboratory’s recommendation, it will be documented.
19.4.1.1 Client Supplied Methods
Most of the client-supplied method requirements presented to us involve achieving specific
quality control criteria, limits of quantitation (LOQ), and/or method detection limits (MDL) using
standard EPA methods. These requirements are communicated to the appropriate technical
groups prior to the project start up. Each technical group evaluates the scope of work and the
requirements to ensure the criteria can be met using the standard EPA method. The data is
monitored to ensure the criteria are met throughout the project. The PM notifies the client if
there is a more appropriate method available or if the client’s criteria cannot be achieved on a
certain sample matrix (i.e., due to matrix or dilutions).
Occasionally, we are asked to transfer a non-standardized method from a client into our lab or
to develop a new method, when one is not available. In the case of a method transfer, we set
up the client’s method and perform some initial evaluation. After the initial evaluation, we may
make recommendations on how to improve method performance. If the method appears to be
adequate, we determine linearity, specificity, precision, accuracy, MDL, and LOQ by performing
calibrations, analyzing method blanks, and carrying out method detection limit and IDOC
studies.
In the case of method development, we work with the client and/or data user to determine the
level of validation required ensuring that the method meets its intended purpose. In addition to
the elements above, we also determine standard and sample stability and robustness
depending on the scope of the project. Typically, a standard operating procedure is written and
submitted to the client with the results of the validation. These steps are completed prior to
analysis of field samples. Data related to the setup of the method are archived.
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19.4.1.2 Procedural Deviations
Analysts are required to follow a documented method for all tests performed; and any deviations
from analytical methods must be documented, approved, and justified in an appropriate and
consistent manner. We classify method deviations as either being a planned deviation or an
unplanned deviation. In general, the following information is captured to document both types of
situations:
Description of the situation
Reason or justification for the deviation
Impact the deviation had on the testing
Signature/date of analyst performing the test (may also be LabServe user identification and
timestamp)
Signature/date of QA and Laboratory management approving the deviation (may also be
LabServe user identification and timestamp)
Signature/date of client approval, if necessary (may also be electronic communication from
client)
Deviations to written procedures are documented in raw data records, LabServe Task System,
or through ICAT. All types of documentation require management and QA review and approval.
19.4.2 Demonstration of Capability
Before the laboratory may institute a new method and begin reporting results, the laboratory
shall confirm that it can properly operate the method. In general, this demonstration does not
test the performance of the method in real world samples, but in an applicable and available
clean matrix sample. If the method is for the testing of analytes that are not conducive to
spiking, demonstration of capability may be performed on quality control samples.
A demonstration of capability (DOC, Lab SOP # EM-AD-S-1646) is performed whenever there is
a change in instrument type (e.g., new instrumentation), matrix, method or personnel (e.g.,
analyst has not performed the test within the last 12 months).
Note: The laboratory shall have a DOC for all analytes included in the methods that the
laboratory performs, and proficiency DOCs for each analyst shall include all analytes that the
laboratory routinely performs. Addition of non-routine analytes does not require new DOCs for
all analysts if those analysts are already qualified for routine analytes tested using identical
chemistry and instrument conditions.
The initial demonstration of capability must be thoroughly documented and approved by the
Facility Manager, Technical Manager (where appropriate), and QA Manager prior to
independently analyzing client samples. All associated documentation must be retained in
accordance with the laboratory’s archiving procedures.
The laboratory must have an approved SOP, demonstrate satisfactory performance, and
conduct an MDL study (when applicable). There may be other requirements as stated within the
published method or regulations (e.g., retention time window study).
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Note:In some instances, a situation may arise where a client requests that an unusual
analyte be reported using a method where this analyte is not normally reported. If the analyte is
being reported for regulatory purposes, the method must meet all procedures outlined within this
QA Manual (SOP, MDL, and Demonstration of Capability). If the client states that the information
is not for regulatory purposes, the result may be reported as long as the following criteria are
met:
The client request is documented and the lab informs the client of its procedure for working
with unusual compounds. The final report must be footnoted: Reporting Limit based on the
low standard of the calibration curve.
19.4.3 Initial Demonstration of Capability (IDOC) Procedures
19.1.1.1 All analysts and technicians are required to demonstrate their ability to produce
reliable results before they perform analysis without direct supervision and document on an
Initial Demonstration of Capability (IDOC) form. This form is to be completed by the QA
Manager and maintained as part of the employee’s training record. (SOP EM-AD-S-1646). The
Initial Demonstration of Capability (IDOC) form is to be completed per procedure/analysis prep.
19.1.1.2 Training timeframes and minimum sample counts are defined by analysis type and
are applicable to initial training. A list of training requirements may be found in the General
Training SOP, EM-AD-S-1646. Where training requirements are undefined, a detailed training
plan is required.
19.1.1.3 Where an analyst has previous documented training, and has met the required
timeframe and minimum sample count for same/like analytical methods, the timeframe and
noted sample count will not be required. Sample training in these situations require
development of a training plan with an appropriate timeframe and appropriate number of
minimum samples.
19.1.1.4 An authorization statement (refer to Figure 19-1 as an example shall be used to
document the completion of each initial demonstration of capability.) A copy of the authorization
is archived in the analyst’s training folder.
19.5 Laboratory Developed Methods and Non-Standard Methods
Eurofins EMLab P&K employs the use of in-house developed methods as well as published
reference methods. Any new method developed by the laboratory must be fully defined in an
SOP and validated by qualified personnel with adequate resources to perform the method.
Method specifications and the relation to client requirements must be clearly conveyed to the
client if the method is a non-standard method (not a published or routinely accepted method).
The client must also be in agreement to the use of the non-standard method.
19.6 Validation of Methods
Validation is the confirmation by examination and the provision of objective evidence that the
particular requirements for a specific intended use are fulfilled.
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All non-standard methods, laboratory designed/developed methods, standard methods used
outside of their scope, and major modifications to published methods must be validated to
confirm they are fit for their intended use. The validation will be as extensive as necessary to
meet the needs of the given application. The results are documented with the validation
procedure used and contain a statement as to the fitness for use.
19.6.1 Method Validation and Verification Activities for All New Methods
While method validation can take various courses, the following activities can be required as
part of method validation. Method validation records are designated QC records and are
archived accordingly.
When changes are made to any validated methods, the influence of such changes shall be
documented and, if appropriate, a new validation shall be performed.
19.6.1.1 Determination of Method Selectivity – Method selectivity is the demonstrated ability
to discriminate the analyte(s) of interest from other compounds in the specific matrix or matrices
from other analytes or interference. In some cases to achieve the required selectivity for an
analyte, a confirmation analysis is required as part of the method.
19.6.1.2 Determination of Method Sensitivity – Sensitivity can be both estimated and
demonstrated. Whether a study is required to estimate sensitivity depends on the level of
method development required when applying a particular measurement system to a specific set
of samples. Detection limit studies are conducted as described in Section 19.7 below. Where
other protocols for estimations and/or demonstrations of sensitivity are required by regulation or
client agreement, these shall be followed.
19.6.1.3 Relationship of Limit of Detection (LOD) to the Limit of Quantitation (LOQ) – An
important characteristic of expression of sensitivity is the distinction between the LOD and the
LOQ. The LOD is the minimum level at which the presence of an analyte can be reliably
concluded. The LOQ is the minimum concentration of analyte that can be quantitatively
determined with acceptable precision and bias, equivalent to the laboratory’s routine reporting
limit (RL). For most instrumental measurement systems, there is a region where semi-
quantitative data is generated around the LOD (both above and below the estimated MDL or
LOD) and below the LOQ. In this region, detection of an analyte may be confirmed but
quantification of the analyte is unreliable within the accuracy and precision guidelines of the
measurement system. When an analyte is detected below the LOQ, and the presence of the
analyte is confirmed by meeting the qualitative identification criteria for the analyte, the analyte
can be reliably reported, but the amount of the analyte can only be estimated. If data is to be
reported in this region, it must be done so with a qualification that denotes the semi-quantitative
nature of the result.
19.6.1.4 Determination of Interferences – A determination that the method is free from
interferences in a blank matrix is performed.
19.6.1.5 Determination of Range – Where appropriate to the method, the quantitation range is
determined by comparison of the response of an analyte in a curve to established or targeted
criteria. Generally the upper quantitation limit is defined by highest acceptable calibration
concentration. The lower quantitation limit or QL cannot be lower than the lowest non-zero
calibration level, and can be constrained by required levels of bias and precision.
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19.6.1.6 Determination of Accuracy and Precision – Accuracy and precision studies are
generally performed using replicate analyses, with a resulting percent recovery and measure of
reproducibility (standard deviation, relative standard deviation) calculated and measured against
a set of target criteria.
19.6.1.7 Documentation of Method – The method is formally documented in an SOP. If the
method is a minor modification of a standard laboratory method that is already documented in
an SOP, an SOP Attachment describing the specific differences in the new method is acceptable
in place of a separate SOP.
19.6.1.8 Continued Demonstration of Method Performance – Continued demonstration of
method performance is addressed in the SOP. Continued demonstration of method
performance is generally accomplished by batch specific QC samples such as LCS, method
blanks or PT samples.
19.7 Method Detection Limit s ( MDL ) / Limits of Detection ( LOD )
The MDL is the minimum measured quantity of a substance that can be reported with 99%
confidence that the concentration is distinguishable from method blank results, consistent with
40CFR Part 136 Appendix B, August, 2017. The MDL is equivalent to the TNI LOD, and is also
equivalent to the DoD/DOE Quality Systems Manual (QSM) DL. The working or final MDL is the
higher of the MDL value determined from spikes (MDLs) and the MDL value determined from
blanks (MDLb). An initial MDL study shall be performed during the method validation process
and when the method is altered in a way that can reasonably be expected to change its sensitivity.
On-going data are collected during each quarter in which samples are being analyzed. At least
once every 13 months the MDLs and MDLb are re-calculated and re-evaluated using data
collected during the preceding period. Refer to the laboratory’s SOP No. EM-AD-S-3548 for
details on the laboratory’s method validation process.
19.8 Verification of Detection Limits
If it is found during the re-evaluation of detection limit results that more than 5% of the spiked
samples do not return positive numeric results that meet all method qualitative identification
criteria, then then spiking level shall be increased and the initial MDL study pre-performed at the
new spiking concentration.
19.9 Instrument Detection Limits (IDL)
The IDL is sometimes used to assess the reasonableness of the MDL or in some cases required
by the analytical method or program requirements. IDLs are most commonly used in metals
analyses but may be useful in demonstration of instrument performance in other areas.
IDLs are calculated to determine an instrument’s sensitivity independent of any preparation
method. IDLs are calculated either using 7 replicate spike analyses, like MDL but without
sample preparation, or by the analysis of 10 instrument blanks and calculating 3 x the absolute
value of the standard deviation.
19.10 Limit of Quantitation
The LOQ shall be at a concentration equivalent to the lowest calibration standard concentration,
with the exception of methods using a single-point calibration, and shall be greater than the
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MDL. The LOQ is verified by preparing and analyzing spikes at concentrations 1-2 times the
selected LOQ, employing the complete analytical process.
When the laboratory establishes a quantitation limit, it must be initially verified by the analysis of
a low level standard or QC sample at 1-2 times the reporting limit and annually thereafter. The
annual requirement is waived for methods that have an annually verified MDL. The laboratory
will comply with any regulatory requirements.
19.11 Estimation of Uncertainty of Measurement
19.11.1 Uncertainty is “a parameter associated with the result of a measurement, that
characterizes the dispersion of the values that could reasonably be attributed to the measurand”
(as defined by the International Vocabulary of Basic and General Terms in Metrology, ISO
Geneva, 1993, ISBN 92-67-10175-1). Knowledge of the uncertainty of a measurement provides
additional confidence in a result’s validity. Its value accounts for all the factors which could
possibly affect the result, such as adequacy of analyte definition, sampling, matrix effects and
interferences, climatic conditions, variances in weights, volumes, and standards, analytical
procedure, and random variation. Some national accreditation organizations require the use of
an “expanded uncertainty” defined as the range within which the value of the measurand is
believed to lie within at least a 95% confidence level with the coverage factor k=2.
19.11.2 Uncertainty is not error. Error is a single value (i.e., the difference between the true
result and the measured result). On environmental samples, the true result is never known.
The measurement is the sum of the unknown true value and the unknown error. Unknown error
is a combination of systematic error, or bias, and random error. Bias varies predictably,
constantly, and independently from the number of measurements. Random error is
unpredictable, assumed to be Gaussian in distribution, and reducible by increasing the number
of measurements.
19.11.3 The minimum uncertainty associated with results generated by the laboratory can be
determined by using the Laboratory Control Sample (LCS) accuracy range for a given analyte.
The LCS limits are used to assess the performance of the measurement system since they take
into consideration all of the laboratory variables associated with a given test over time (except
for variability associated with the sampling and the variability due to matrix effects). The percent
recovery of the LCS is compared either to the method-required LCS accuracy limits or to the
statistical, historical, in-house LCS accuracy limits.
19.11.4 To calculate the uncertainty for the specific result reported, refer to SOP EM-QA-S-
1960.
19.11.5 In the case where a well-recognized test method specifies limits to the values of
major sources of uncertainty of measurement (e.g., 524.2, 525, etc.) and specifies the form of
presentation of calculated results, no further discussion of uncertainty is required.
19.12 Sample Reanalysis Guidelines
Because there is a certain level of uncertainty with any analytical measurement, a sample re-
preparation (where appropriate) and subsequent analysis (hereafter referred to as ‘reanalysis’)
may result in either a higher or lower value from an initial sample analysis. There are also
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variables that may be present (e.g., sample homogeneity, analyte precipitation over time, etc.)
that may affect the results of a reanalysis. Based on the above comments, the laboratory will
reanalyze samples at a client’s request with the following caveats. Client specific Contractual
Terms & Conditions for reanalysis protocols may supersede the following items.

If the reanalysis does not agree (as defined above) with the original result, then the
laboratory will investigate the discrepancy and reanalyze the sample a third time for
confirmation if sufficient sample is available.
Any potential charges related to reanalysis are discussed in the contract terms and
conditions or discussed at the time of the request. The client will typically be charged for
reanalysis unless it is determined that the lab was in error.
Due to the potential for increased variability, reanalysis may not be applicable to Non-
homogenous, Encore, and Sodium Bisulfate preserved samples. See the Area Supervisor or
Laboratory Director if unsure.
19.13 Control of Data
The laboratory has policies and procedures in place to ensure the authenticity, integrity, and
accuracy of the analytical data generated by the laboratory.
19.13.1 Computer and Electronic Data Related Requirements
The three basic objectives of our computer security procedures and policies are shown below.
The laboratory is currently using the Eurofins EMLab P&K LabServe system, a proprietary in-
house developed LIMS system. It is referred to as LabServe for the remainder of this section.
Labserve utilizes a Microsoft SQL database which is an industry standard relational database
platform.
19.13.1.1 Maintain the Database Integrity – Assurance that data is reliable and accurate
through data verification (review) procedures, password-protecting access, anti-virus protection,
data change requirements, as well as an internal LIMS permissions procedure.
LIMS Database Integrity is achieved through data input validation, internal user controls,
documentation of system failures and corrective actions taken, and data change
requirements.
Spreadsheets and other software developed in-house must be verified with documentation
through hand calculations prior to use. Cells containing calculations must be lock-protected
and controlled.
Instrument hardware and software adjustments are safeguarded through maintenance logs,
audit trails and controlled access.
Custom built software applications, as well as significantly modified off the shelf software,
are validated for performing accurate mathematical calculations and transposition of non-
numerical information. Whenever the computer software is edited or changed, the
computation and transposition processes are revalidated using a computerized test suite in
the potentially affected areas prior to the software being used to gather or report data. Data
are checked for the following processes:
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o Data accuracy during data collection and storage
o Data integrity and confidentiality during data storage
o Integrity of data following electronic transmission to clients
All software validations and associated process checks are to be fully documented within
the Bugzilla system. All supporting spreadsheets, documents, etc. are to be attached to the
validation record within Bugzilla.
19.13.1.2 Ensure Information Availability – Protection against loss of information or service is
ensured through scheduled back-ups, stable file server network architecture, secure storage of
media, line filter, Uninterruptible Power Supply (UPS), and maintaining older versions of
software as revisions are implemented.
19.13.1.3 Maintain Confidentiality – Ensure data confidentiality through physical access
controls such as password protection or website access approval when electronically
transmitting data.
19.13.2 Data Reduction
The complexity of the data reduction depends on the analytical method and the number of discrete
operations involved (e.g., extractions, dilutions, instrument readings and concentrations). The
analyst calculates the final results from the raw data or uses appropriate computer programs to
assist in the calculation of final reportable values.
Analytical results are reduced to appropriate concentration units specified by the analytical
method, taking into account factors such as dilution, sample weight or volume, etc. Blank correction
will be applied only when required by the method or per manufacturer’s indication; otherwise, it
should not be performed. Calculations are independently verified by appropriate laboratory staff.
Calculations and data reduction steps for various methods are summarized in the respective
analytical SOPs or program requirements.
19.13.2.1 All raw data must be retained with the project folder, computer file (if appropriate),
and/or appropriate log. All criteria pertinent to the method must be recorded. The documentation
is recorded at the time observations or calculations are made and must be signed or
initialed/dated (month/day/year). It must be easily identifiable who performed which tasks if
multiple people were involved.
19.13.2.2 Detection and reporting limits for analyses are unique to the method being
performed. Detection and reporting limits are defined within the respective analytical
procedures, where applicable. They are also listed on final reports, where applicable.
19.13.2.3 Due to the nature of biological data the number of significant figures that are used for
interpretation should generally be one or two. Therefore data generated by the laboratory is
reported with a maximum of two significant figures, unless the use of additional significant
figures is warranted by specific analytical reporting requirements.
19.13.2.4 For those methods that do not have an instrument printout or an instrumental output
compatible with the LabServe System, the raw results and dilution factors are entered directly
into LabServe by the analyst, and the software calculates the final result for the analytical report.
LabServe has a defined significant figure criterion for each analyte.
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19.13.2.5 The laboratory strives to import data directly from instruments or calculation
spreadsheets to ensure that the reported data are free from transcription and calculation errors.
For those analyses with an instrumental output compatible with LabServe, the raw results and
dilution factors are transferred into LabServe electronically after reviewing the quantitation
report, and removing unrequested or poor spectrally-matched compounds. The analyst prints a
copy of what has been entered to check for errors. This printout and the instrument’s printout of
calibrations, concentrations, retention times, chromatograms, and mass spectra, if applicable,
are retained with the data file. The data file is stored in a monthly folder on the instrument
computer; periodically, this file is transferred to the server and, eventually, to a tape file.
19.13.3 Logbook / Worksheet Use Guidelines
Logbooks and worksheets are filled out ‘real time’ and have enough information on them to
trace the events of the applicable analysis/task. (e.g. calibrations, standards, analyst, sample
ID, date, time on short holding time tests, temperatures when applicable, calculations are
traceable, etc.)
Corrections are made following the procedures outlined in Section 12.
Logbooks are controlled by the QA department. A record is maintained of all logbooks in the
lab.
Unused portions of pages must be “Z”’d out, signed and dated.
Worksheets are created with the approval of the Regional Manager and QA Manager at the
facility. The QA Manager controls all worksheets following the procedures in Section 6.
19.13.4 Review / Verification Procedures
Review procedures are outlined in several SOPs (e.g. Sample Receiving (EM-SM-S-1288),
Sample Log In (EM-SM-S-1993), Technical Report Review and Release Procedures (EM-SM-S-
1637) to ensure that reported data are free from calculation and transcription errors, that QC
parameters have been reviewed and evaluated before data is reported. The general review
concepts are discussed below, more specific information can be found in the SOPs.
19.13.4.1 Log-In Review - The data review process starts at the sample receipt stage. Sample
control personnel review chain-of-custody forms and project instructions from the project
management group. This is the basis of the sample information and analytical instructions
entered into LabServe. The log-in instructions are reviewed by the personnel entering the
information, and a second level review is conducted by the project management staff.
19.13.4.2 First Level Data Review - The next level of data review occurs with the analysts. As
data are generated, analysts review their work to ensure that the results meet project and SOP
requirements. First level reviews include inspection of all raw data (e.g., raw data sheets, logs,
etc.), evaluation of calibration/calibration verification data in the day’s analytical run, evaluation
of QC data, and reliability of sample results. The analyst transfers data not already directly
entered into LabServe, data qualifiers are added as needed. All first level reviews are
documented.
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19.13.4.3 Second Level Data Review – All analytical data are subject to review by a second
qualified analyst or supervisor. Second level reviews include inspection of all raw data including
100% of data associated with any changes made by the primary analyst. The second review
also includes evaluation of QC data, reliability of sample results, qualifiers, and project tasks.
Manual calculations are checked in second level review. All second level reviews are
documented.
Issues that deem further review include the following:
QC data are outside the specified control limits for accuracy and precision
Reviewed sample data does not match with reported results
Unusual detection limit changes are observed
Samples having unusually high results
Samples exceeding a known regulatory limit
Raw data indicating some type of contamination or poor technique
Transcription errors
Results outside of calibration range
19.13.4.4 Unacceptable analytical results may require reanalysis of the samples. Any
problems are brought to the attention of the Laboratory Director, Project Manager, Quality
Manager, Technical Manager, or Supervisor for further investigation. Corrective action is
initiated whenever necessary.
19.13.4.5 The review process includes, but is not limited to, verifying that the COC is followed,
report comments are present where necessary, comments are appropriate, and project specific
requirements are met.
20.0 EQUIPMENT and CALIBRATIONS
20.1 Overview
The laboratory purchases the most technically advanced analytical instrumentation for sample
analyses. Instrumentation is purchased on the basis of accuracy, dependability, efficiency and
sensitivity. Each laboratory is furnished with all items of sampling, preparation, analytical testing
and measurement equipment necessary to correctly perform the tests for which the laboratory
has capabilities. Each piece of equipment is capable of achieving the required accuracy and
complies with specifications relevant to the method being performed. Before being placed into
use, the equipment (including sampling equipment) is calibrated and checked to establish that it
meets its intended specification. The calibration routines for analytical instruments establish the
range of quantitation. Calibration procedures are specified in SOP EM-EQ-S-1584. A list of
available laboratory instrumentation, per facility, is maintained by Quality Assurance in QA server
folders.
Equipment is only operated by authorized and trained personnel. Manufacturer’s instructions
for equipment use are readily accessible to all appropriate laboratory personnel.
20.2 Preventive Maintenance

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The laboratory follows a well-defined maintenance program to ensure proper equipment
operation and to prevent the failure of laboratory equipment or instrumentation during use. This
program of preventive maintenance helps to avoid delays due to instrument failure.
Routine preventive maintenance procedures and frequency, such as cleaning and
replacements, should be performed according to the procedures outlined in the manufacturer's
manual. Qualified personnel must also perform maintenance when there is evidence of
degradation of peak resolution, a shift in the calibration curve, loss of sensitivity, or failure to
continually meet one of the quality control criteria.
Scheduled routine maintenance is defined in SOP EM-EQ-S-1584. It is the responsibility of each
Facility Manager and/or designee to ensure that instrument maintenance logs are kept for all
equipment in his/her facility. Preventative maintenance procedures are outlined in EM-EQ-S-
1584 and may also be outlined in analytical SOPs or instrument manuals. (Note: for some
equipment, the log used to monitor performance is also the maintenance log. Multiple pieces of
equipment may share the same log as long as it is clear as to which instrument is associated with
an entry.)
Instrument maintenance logs are controlled and are used to document instrument problems,
instrument repair and maintenance activities. Maintenance logs shall be kept for all major pieces
of equipment. Instrument maintenance logs may also be used to specify instrument parameters.
Documentation must include all major maintenance activities such as contracted preventive
maintenance and service and in-house activities such as the replacement of electrical
components, lamps, tubing, valves, columns, detectors, cleaning and adjustments.
Each entry in the instrument log includes the analyst's initials, the date, a detailed description
of the problem (or maintenance needed/scheduled), a detailed explanation of the solution or
maintenance performed, and a verification that the equipment is functioning properly (state
what was used to determine a return to control. e.g. instrument recalibrated on ‘date’ with
acceptable verification, etc.) must also be documented in the instrument records.
When maintenance or repair is performed by an outside agency, service receipts detailing
the service performed are to be maintained as part of facility equipment records.
If an instrument requires repair (subjected to overloading or mishandling), gives suspect results,
or otherwise has shown to be defective or outside of specified limits it shall be taken out of
operation and tagged as out-of-service or otherwise isolated until such a time as the repairs have
been made and the instrument can be demonstrated as operational by calibration and/or
verification or other test to demonstrate acceptable performance. The laboratory shall examine
the effect of this defect on previous analyses.
In the event of equipment malfunction that cannot be resolved, service shall be obtained from
the instrument vendor manufacturer, or qualified service technician, if such a service can be
tendered. If on-site service is unavailable, arrangements shall be made to have the instrument
shipped back to the manufacturer for repair. Back up instruments, which have been approved,
for the analysis shall perform the analysis normally carried out by the malfunctioning instrument.
If the back-up is not available and the analysis cannot be carried out within the needed
timeframe, the samples shall be subcontracted.
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At a minimum, if an instrument is sent out for service or transferred to another facility, it must be
verified as functional upon return or repair prior to return to lab operations.
20.3 Support Equipment
This section applies to all devices that may not be the actual test instrument, but are necessary
to support laboratory operations. These include but are not limited to: balances, ovens,
refrigerators, freezers, incubators, water baths, temperature measuring devices, and volumetric
dispensing devices if quantitative results are dependent on their accuracy, as in standard
preparation and dispensing or dilution into a specified volume. All raw data records associated
with the support equipment are retained to document instrument performance. Additional
information and requirements may be found in SOP EM-EQ-S-1584.
20.3.1 Weights and Balances
The accuracy of the balances used in the laboratory is checked every working day, before use.
All balances are placed on stable counter tops.
Each balance is checked prior to initial serviceable use with at least two certified ASTM type 1
weights spanning its range of use (weights that have been calibrated to ASTM type 1 weights
may also be used for daily verification). ASTM type 1 weights used only for calibration of other
weights (and no other purpose) are inspected for corrosion, damage or nicks at least annually
and if no damage is observed, they are calibrated at least every 5 years by an outside
calibration laboratory. Any weights (including ASTM Type 1) used for daily balance checks or
other purposes are recalibrated/recertified every two years to NIST standards (this may be done
internally if laboratory maintains “calibration only” ASTM type 1 weights).
All balances are serviced annually by a qualified service representative, who supplies the
laboratory with a certificate that identifies traceability of the calibration to the NIST standards.
All of this information is recorded in logs, and the recalibration/recertification certificates are kept
on file.
20.3.2 pH, Conductivity, and Turbidity Meters
The pH meters used in the laboratory are accurate to + 0.1 pH units, and have a scale
readability of at least 0.05 pH units. The meters automatically compensate for the temperature,
and are calibrated with at least two working range buffer solutions before each use.
Conductivity meters are also calibrated before each use with a known standard to demonstrate
the meters do not exceed an error of 1% or one umhos/cm.
Turbidity meters are also calibrated before each use. All of this information is documented in
logs.
Consult pH, Conductivity, and Turbidity SOPs for further information.
20.3.3 Thermometers
All thermometers are calibrated on an annual basis with a NIST-traceable thermometer.
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If the temperature measuring device is used over a range of 10°C or less, then a single point
verification within the range of use is acceptable;
If the temperature measuring device is used over a range of greater than 10°C, then the
verification must bracket the range of use.
IR thermometers and digital thermometers are calibrated every 6 months, (or quarterly where
required by external accrediting bodies).
The NIST reference thermometer is recalibrated every five years (unless thermometer has been
exposed to temperature extremes or apparent separation of internal liquid) by an approved
outside service and the provided certificate of traceability is kept on file. The NIST
thermometer(s) have increments of 1 degree (0.5 degree or less increments are required for
drinking water microbiological laboratories), and have ranges applicable to method and
certification requirements. The NIST traceable thermometer is used for no other purpose than
to calibrate other thermometers.
All of this information is documented in logs. Monitoring method-specific temperatures, including
incubators, heating blocks, water baths, and ovens, is documented in equipment-specific logs.
More information on this subject can be found in the Calibration and Maintenance of Lab
Equipment SOP, EM-EQ-S-1584.
20.3.4 Refrigerators/Freezer Units, Water baths, Ovens and Incubators
The temperatures of all refrigerator units and freezers used for sample and standard storage are
monitored each working day, at minimum. Temperatures are recorded twice daily, with a
minimum 4 hours between readings for days in use.
Ovens, water baths and incubators are monitored on days of use.
All of this equipment has a unique identification number, and is assigned a thermometer for
monitoring.
Sample storage refrigerator temperatures are kept between 2ºC and 8 ºC.
Specific temperature settings/ranges for other refrigerators, ovens, water baths, and incubators
can be found in method specific SOPs.
All of this information is documented in Daily Temperature Logs and/or electronic data logger
records.
20.3.5 Autopipettors, Dilutors, and Syringes
Mechanical volumetric dispensing devices are given unique identification numbers and the
delivery volumes are verified, at a minimum, on a monthly basis. Monthly pipette verification and
annual calibration procedures are found in SOP EM-EQ-S-1584.
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For those dispensers that are not used for analytical measurements, a label can be applied to
the device stating that it is not calibrated and not for use in analysis. Any device not regularly
verified cannot be used for any quantitative measurements.
20.3.6 Autoclaves
Each autoclave requires routine maintenance and cleaning to ensure functionality of the unit.
Process controls are in place daily, weekly, and quarterly to ensure that the unit is performing as
required with respect to time, temperature and sterilization requirements. Details of required
maintenance can be found in manufacturer manuals as well as SOP Autoclave Operation and
Maintenance SOP, EM-EQ-S-1198.
20.3.7 Microscopes
The routine maintenance of microscopes is outlined in Document EM-EQ-S-1586 "Routine
Maintenance of Microscopes". Microscope Ocular Micrometers are calibrated annually with an
NIST traceable micrometer per Document EM-EQ-S-1588 "Ocular Micrometer Calibration".
Records of the maintenance and ocular micrometer calibrations are maintained as part of the
Quality System documentation.
For those microscopes used in PCM analysis, routine maintenance and alignment requirements
are outlined with the analytical Document EM-AS-S-1260 "PCM Analysis for Asbestos and Other
Fibers".
For those microscopes used in Asbestos PLM analysis, routine maintenance and alignment
requirements are outlined with the analytical Document EM-AS-S-1267 "Sample Preparation
and Analysis for Asbestos Fibers by Polarized Light Microscopy (PLM)".
20.3.8 Ventilation and Decontamination
Class II Biosafety hoods are certified on an annual basis by a NSF accredited field certifier to
ensure that the hoods are functioning according to the specifications outlined in NSF Standard
49 and the Chapter 13 of the ASHRAE Applications Notebook (1999). The records for the hood
calibration are maintained at each facility.
All other Biohazard hoods, including Class I with HEPA filter used for asbestos, are certified on
an annual basis by an ISO/IEC 17025:2017 accredited vendor.
Hoods used for asbestos analyses must operate at a minimum 75 fpm or they shall not be used
for asbestos work.
20.4 Instrument Calibrations
Calibration of analytical instrumentation is essential to the production of quality data. Strict
calibration procedures are followed for each method. These procedures are designed to
determine and document the method detection limits, the working range of the analytical
instrumentation and any fluctuations that may occur from day to day.
Sufficient raw data records are retained to allow an outside party to reconstruct all facets of the
initial calibration. Records contain, but are not limited to, the following: calibration date, method,
instrument, analyst(s) initials or signatures, analysis date, analytes, concentration, response,
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and type of calibration (Avg RF, curve, or other calculations that may be used to reduce
instrument responses to concentration.)
Sample results must be quantitated from the initial calibration and may not be quantitated from
any continuing instrument calibration verification unless otherwise required by regulation,
method or program.
If the initial calibration results are outside of the acceptance criteria, corrective action is
performed and any affected samples are reanalyzed if possible. If the reanalysis is not
possible, any data associated with an unacceptable initial calibration will be reported with
appropriate data qualifiers (refer to Section 12).
Note:Instruments are calibrated initially and as needed after that and at least annually.
20.4.1 Calibration Standards
Calibration standards are prepared using the procedures indicated in the Reagents and
Standards section of the determinative method SOP. If a reference method does not specify the
number of calibration standards, a minimum of 3 calibration points will be used.
Standards for instrument calibration are obtained from a variety of sources. All standards are
traceable to national or international standards of measurement, or to national or international
standard reference materials.
The lowest concentration calibration standard that is analyzed during an initial calibration must
be at or below the stated reporting limit for the method based on the final volume of extract (or
sample).
The other concentrations define the working range of the instrument/method or correspond to
the expected range of concentrations found in actual samples that are also within the working
range of the instrument/method. Results of samples not bracketed by initial instrument
calibration standards (within calibration range to at least the same number of significant figures
used to report the data) must be reported as having less certainty, e.g., defined qualifiers or
flags (additional information may be included in the case narrative).
All initial calibrations are verified with a standard obtained from a second source and traceable
to a national standard, when available (or vendor certified different lot if a second source is not
available). For unique situations, such as air analysis where no other source or lot is available,
a standard made by a different analyst at a different time or a different preparation would be
considered a second source. This verification occurs immediately after the calibration curve has
been analyzed, and before the analysis of any samples.
20.4.1.1 Calibration Verification
The calibration relationship established during the initial calibration must be verified initially and
at least daily as specified in the laboratory method SOPs in accordance with the referenced
analytical methods and in the 2009 and 2016 TNI Standard. The process of calibration
verification applies to both external standard and internal standard calibration techniques, as
well as to linear and non-linear calibration models. Initial calibration verification (ICV) is with a
standard source secondary (second source standard) to the calibration standards, but
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continuing calibration verifications (CCV) may use the same source standards as the calibration
curve.
Note:The process of calibration verification referred to here is fundamentally different from
the approach called "calibration" in some methods. As described in those methods, the
calibration factors or response factors calculated during calibration are used to update the
calibration factors or response factors used for sample quantitation. This approach, while
employed in other EPA programs, amounts to a daily single-point calibration.
All target analytes and surrogates, including those reported as non-detects, must be included in
periodic calibration verifications for purposes of retention time confirmation and to demonstrate
that calibration verification criteria are being met, i.e., RPD, per 2009 and 2016 TNI Std. EL-
V1M4 Sec. 1.7.2.
All samples must be bracketed by periodic analyses of standards that meet the QC acceptance
criteria (e.g., calibration and retention time). The frequency is found in the determinative
methods or SOPs.
Note:If an internal standard calibration is being used then bracketing calibration
verification standards are not required, only daily verifications are needed. The results from
these verification standards must meet the calibration verification criteria and the retention time
criteria (if applicable).
Generally, the calibrations must be verified by an ICV analyzed immediately following initial
calibration and before sample analysis. The ICV may be used as the first bracketing CCV, if
criteria for both are met.
A continuing instrument calibration verification (CCV) is generally analyzed at the beginning of
each 12-hour analytical shift during which samples are analyzed. The 12-hour analytical shift
begins with the injection of the calibration verification standard (or the MS tuning standard in MS
methods). The shift ends after the completion of the analysis of the last sample, QC, or standard
that can be injected within 12-hours of the beginning of the shift. For methods that have
quantitation by external calibration models, a CCV is analyzed at the end of each analytical
sequence. Some methods have more frequent CCV requirements. See specific SOPs. Most
inorganic methods require the CCV to be analyzed after ever 10 samples or injections, including
matrix or batch QC samples.
Note: If an internal standard calibration is being used (e.g., GCMS) then bracketing standards
are not required, only daily verifications are needed, except as specified by program or method
requirements.
If the results of a CCV are outside the established acceptance criteria and analysis of a second
consecutive (and immediate) CCV fails to produce results within acceptance criteria, corrective
action shall be performed. Once corrective actions have been completed and documented, the
laboratory shall demonstrate acceptable instrument / method performance by analyzing two
consecutive CCVs, or a new initial instrument calibration shall be performed.
Sample analyses and reporting of data may not occur or continue until the analytical system is
calibrated or calibration verified. However, data associated with an unacceptable calibration
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verification may be fully useable reported based upon discussion and approval of the client
under the following special conditions:
a).when the acceptance criteria for the CCV are exceeded high (i.e., high bias) and the
associated samples within the batch are non-detects, then those non-detects may be reported
case narrative comment explaining the high bias. Otherwise the samples affected by the
unacceptable CCV shall be re-analyzed after a new calibration curve has been established,
evaluated and accepted; or
b).when the acceptance criteria for the CCV are exceeded low (i.e., low bias), those sample
results may be reported if they exceed a maximum regulatory limit/decision level. Otherwise the
samples affected by the unacceptable CCV shall be re-analyzed after a new calibration curve
has been established, evaluated and accepted.
Samples reported by the 2 conditions identified above will be appropriately flagged.
20.4.1.2 Verification of Linear and Non-Linear Calibrations
Calibration verification for calibrations involves the calculation of the percent drift or the percent
difference of the instrument response between the initial calibration and each subsequent
analysis of the verification standard. (These calculations are available in the laboratory method
SOPs.) Verification standards are evaluated based on the % Difference from the average CF or
RF of the initial calibration or based on % Drift or % Recovery if a linear or quadratic curve is
used.
Regardless of whether a linear or non-linear calibration model is used, if initial verification
criterion is not met, then no sample analyses may take place until the calibration has been
verified or a new initial calibration is performed that meets the specifications listed in the method
SOPs. If the calibration cannot be verified after the analysis of a single verification standard,
then adjust the instrument operating conditions and/or perform instrument maintenance, and
analyze another aliquot of the verification standard. If the calibration cannot be verified with the
second standard, then a new initial calibration is performed.
When the acceptance criteria for the calibration verification are exceeded high, i.e., high
bias, and there are associated samples that are non-detects, then those non-detects may be
reported. Otherwise, the samples affected by the unacceptable calibration verification shall
be reanalyzed after a new calibration curve has been established, evaluated and accepted.
When the acceptance criteria for the calibration verification are exceeded low, i.e., low bias,
those sample results may be reported if they exceed a maximum regulatory limit/decision
level. Otherwise, the samples affected by the unacceptable verification shall be reanalyzed
after a new calibration curve has been established, evaluated and accepted. Alternatively, a
reporting limit standard may be analyzed to demonstrate that the laboratory can still support
non-detects at their reporting limit.
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21.0 MEASUREMENT TRACEABILITY
21.1 Overview
Traceability of measurements shall be assured using a system of documentation, calibration,
and analysis of reference standards. Laboratory equipment that are peripheral to analysis and
whose calibration is not necessarily documented in a test method analysis or by analysis of a
reference standard shall be subject to ongoing certifications of accuracy. At a minimum, these
must include procedures for checking specifications of ancillary equipment: balances,
thermometers, temperature, Deionized (DI) and Reverse Osmosis (RO) water systems,
automatic pipettes and other volumetric measuring devices. (Refer to Section 20.3). With the
exception of Class A Glassware and glass microliter syringes, quarterly accuracy checks (at
minimum) are performed for all mechanical volumetric devices. Wherever possible, subsidiary
or peripheral equipment is checked against standard equipment or standards that are traceable
to national or international standards. Class A Glassware and glass microliter syringes should
be routinely inspected for chips, acid etching or deformity (e.g., bent needle). If the Class A
glassware or syringe is suspect, the accuracy of the glassware will be assessed prior to use.
All reusable glassware and plasticware that is used in the analysis of samples must be cleaned,
and where appropriate, sterilized according to Document EM-EQ-S-5810 "Glassware Cleaning".
All glassware shall be inspected for cracks and chips before each time it is used. If cracks or
chips are found, the glassware shall not be used and shall be repaired or discarded.

21.2 NIST-Traceable Weights and Thermometers
Reference standards of measurement shall be used for calibration only and for no other
purpose, unless it can be shown that their performance as reference standards would not be
invalidated.
For NIST-traceable weights and thermometers, the laboratory requires that all calibrations be
conducted by a calibration laboratory accredited by A2LA, NVLAP (National Voluntary
Laboratory Accreditation Program), or another accreditation organization that is a signatory to a
MRA (Mutual Recognition Arrangement) of one or more of the following cooperations – ILAC
(International Laboratory Accreditation Cooperation) or APLAC (Asia–Pacific Laboratory
Accreditation Cooperation). A calibration certificate and scope of accreditation is kept on file at
the laboratory.
21.3 Reference Standards / Materials
Reference standards/materials, where commercially available, are traceable to certified
reference materials. Commercially prepared reference standards, to the extent available, are
purchased from vendors that are accredited to ISO Guide 34 and ISO/IEC Guide 17025:2017.
All reference standards from commercial vendors shall be accompanied with a certificate that
includes at least the following information:
Manufacturer
Analytes or parameters calibrated
Identification or lot number
Calibration method
Concentration with associated uncertainties
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Purity
If a standard cannot be purchased from a vendor that supplies a Certificate of Analysis, the
purity of the standard is documented by analysis. The receipt of all reference standards must be
documented. Reference standards are labeled with a unique ID and expiration date. All
documentation received with the reference standard is retained as a QC record and references
the unique ID.
All reference, primary and working standards/materials, whether commercially purchased or
laboratory prepared, must be checked regularly to ensure that the variability of the standard or
material from the true value does not exceed method requirements. The accuracy of calibration
standards is checked by comparison with a standard from a second source. In cases where a
second standard manufacturer is not available, a vendor certified different lot is acceptable for
use as a second source. For unique situations, such as air analysis where no other source or
lot is available, a standard made by a different analyst would be considered a second source.
The appropriate Quality Control (QC) criteria for specific standards are defined in laboratory
SOPs. In most cases, the analysis of an Initial Calibration Verification (ICV) or LCS (where
there is no sample preparation) is used as the second source confirmation. These checks are
generally performed as an integral part of the analysis method (e.g. calibration checks,
laboratory control samples).
All standards and materials must be stored and handled according to method or manufacturer’s
requirements in order to prevent contamination or deterioration. Refer to the Environmental
Health & Safety Manual or laboratory SOPs. For safety requirements, please refer to method
SOPs and the laboratory’s Environmental Health and Safety Manual.
Standards and reference materials shall not be used after their expiration dates unless their
reliability is verified by the laboratory and their use is approved by the Quality Assurance
Manager. The laboratory must have documented contingency procedures for re-verifying
expired standards.
21.4 Documentation and Labeling of Standards, Reagents, and Reference Materials
Reagents must be at a minimum the purity required in the test method. The date of reagent
receipt and the expiration date are documented.
All manufacturer or vendor supplied Certificate of Analysis or Purity must be retained, stored
appropriately, and readily available for use and inspection. These records are maintained on-site
with each facility’s current QA/QC records. Records must be kept of the date of receipt and
date of expiration of standards, reagents and reference materials. In addition, records of
preparation of laboratory standards, reagents, and reference materials must be retained, stored
appropriately, and be readily available for use and inspection. For detailed information on
documentation and labeling, please refer to facility Supply Receiving and Distribution SOPs.
Wherever possible, cultures purchased for use as control or reference cultures and inclusion in
laboratory stock must be obtained from external sources traceable to Guide 34 such as, but not
limited to, American Type Culture Collection (ATCC), Hardy Diagnostics and other commercially
available traceable culture catalogs. It is not permissible to retain AIHA-EMPAT proficiency
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testing rounds for inclusion in stock culture collections due to licensing agreements in place with
AIHA-PAT, LLC.
All standards, reagents, and reference materials must be labeled in an unambiguous manner.
Records are maintained for standard and reference material preparation. These records show
the traceability to purchased stocks or neat compounds. These records also include method of
preparation, date of preparation, expiration date and preparer’s name or initials. Preparation
procedures are provided in the Method SOPs.
Commercial materials purchased for preparation of calibration solutions, spike solutions, etc..,
are usually accompanied with an assay certificate or the purity is noted on the label. If the assay
purity is 96% or better, the weight provided by the vendor may be used without correction. If the
assay purity is less than 96% a correction will be made to concentrations applied to solutions
prepared from the stock commercial material. Blended gas standard cylinders use a nominal
concentration if the certified value is within +/-15%, otherwise the certified values is used for the
canister concentration.
21.4.1 All standards, reagents, and reference materials must be labeled in an unambiguous
manner.
Records are maintained for standard and reference material preparation. These records show
the traceability to purchased stocks or neat compounds. These records also include method of
preparation, date of preparation, expiration date and preparer’s name or initials. Preparation
procedures are provided in the Method SOPs.
21.4.2 All standards, reagents, and reference materials must be clearly labeled with a minimum
of the following information:
Lot number
Expiration Date (include prep date for reagents)
Standard ID
Special Health/Safety warnings if applicable
Records must also be maintained of the date of receipt for commercially purchased items or
date of preparation for laboratory prepared items. Special Health/Safety warnings must also be
available to the analyst. This information is maintained on-site with each facility’s current
QA/QC records.
21.4.3 In addition, the following information may be helpful:
Date opened (for multi-use containers, if applicable)
Description of standard (if different from manufacturer’s label or if standard was prepared in
the laboratory)
Recommended Storage Conditions
Concentration (if applicable)
Initials of analyst preparing standard or opening container
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All containers of prepared reagents must include an expiration date and an ID number to trace
back to preparation.
Procedures for preparation of reagents can be found in the Method SOPs.
Standard ID numbers must be traceable through associated logbooks, worksheets and
preparation/analytical batch records.
All reagents and standards must be stored in accordance to the following priority: 1) with the
manufacturer’s recommendations; 2) with requirements in the specific analytical methods as
specified in the laboratory SOP.
22.0 SAMPLING
22.1 Overview
Eurofins EMLab P&K, LLC does not offer sampling services. Rare exceptions have been made
upon high profile client request. Such requests are to include client specified sampling plans
and are reviewed and approved on a case by case basis by the General Manager and Cluster
Leader. Such requests and dictated protocols are documented as part of the client account
records. Clients of the laboratory are supplied, upon request, with Eurofins EMLab P&K, LLC
Chain of Custody (COC) forms, and written information regarding the use of sampling devices
and sampling procedures. Clients may also obtain these materials and a detailed list of
sampling procedures from the Eurofins EMLab P&K, LLC internet site.
22.2 Sampling Containers
The laboratory offers clean sampling containers for use by clients. These containers are
obtained from reputable container manufacturers. Certificates of cleanliness for bottles and
preservatives are provided by the supplier and are maintained at the laboratory. Alternatively,
the certificates may be maintained by the supplier and available to the laboratory on-line.
Internally, a representative sample from new lots of sample containers are checked for sterility
and records maintained per lot.
22.2.1 Preservatives
Upon request, preservatives are provided to the client in pre-cleaned sampling containers. In
some cases containers may be purchased pre-preserved from the container supplier. Whether
prepared by the laboratory or bought pre-preserved, the grades of the preservatives are at a
minimum:
Sodium Thiosulfate – ACS Grade or equivalent
22.3 Definition of Holding Time
The date and time of sampling documented on the COC form establishes the day and time zero.
As a general rule, when the maximum allowable holding time is expressed in days (e.g., 14
days, 28 days), the holding time is based on calendar day measured. Holding times expressed
in hours (e.g., 6 hours, 24 hours, etc.) are measured from date and time zero. Holding times for
analysis include any necessary reanalysis. However, there are some programs that determine
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holding time compliance based on the date and specific time of analysis compared to the time of
sampling regardless of how long the holding time is.
22.4 Sampling Containers, Preservation Requirements, Holding Times
The preservation and holding time criteria specified in the laboratory SOPs are derived from the
source documents for the methods. If method required holding times or preservation
requirements are not met, the reports will be qualified using a report comment. As soon as
possible or “ASAP” is an EPA designation for tests for which rapid analysis is advised, but for
which neither EPA nor the laboratory have a basis for a holding time.
22.5 Sample Aliquots / Subsampling
Taking a representative sub-sample from a container is necessary to ensure that the analytical
results are representative of the sample collected in the field. The size of the sample container,
the quantity of sample fitted within the container, and the homogeneity of the sample need
consideration when sub-sampling for sample preparation. It is the laboratory’s responsibility to
take a representative subsample or aliquot of the sample provided for analysis.
Analysts should handle each sample as if it is potentially dangerous. At a minimum, safety
glasses (where applicable), gloves, and lab coats must be worn when preparing aliquots for
analysis.
Only open asbestos samples in appropriate HEPA filtered hoods with a minimum flow rate of 75
fpm.
Guidelines on taking sample aliquots & subsampling are located in individual method SOPs.
23.0 HANDLING OF SAMPLES
Sample management procedures at the laboratory ensure that sample integrity and custody are
maintained and documented from sampling/receipt through disposal.
Consider every sample as potentially dangerous. Handle samples in manner that reduces the
potential of contamination to others and the laboratory environment.
Wipe every surface involved in the processing of samples with disinfectant after working with
the samples.
Do not leave the lids off of plates at any time, and if necessary reseal plates with parafilm after
analysis.
It is every employee's responsibility to report any safety concerns or incidence of non-
compliance to supervisors, quality assurance officer, safety coordinator, or corporate
management.
23.1 Chain of Custody (COC)
The COC form is the written documented history of any sample and is initiated when bottles are
sent to the field, or at the time of sampling. This form is completed by the sampling personnel
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and accompanies the samples to the laboratory where it is received and stored under the
laboratory’s custody. The purpose of the COC form is to provide a legal written record of the
handling of samples from the time of collection until they are received at the laboratory. It also
serves as the primary written request for analyses from the client to the laboratory. The COC
form acts as a purchase order for analytical services when no other contractual agreement is in
effect. An example of a COC form may be found in Figure 23-1.
23.1.1 Field Documentation
When the sampling personnel deliver the samples directly to Eurofins EMLab P&K personnel,
the samples are stored in a cooler with ice, as applicable, and remain solely in the possession
of the client’s field technician until the samples are delivered to the laboratory personnel. The
sample collector must assure that each container is in his/her physical possession or in his/her
view at all times, or stored in such a place and manner to preclude tampering. The field
technician relinquishes the samples in writing on the COC form to the sample control personnel
at the laboratory or to a Eurofins courier. When sampling personnel deliver the samples through
a common carrier (Fed-Ex, UPS), the CoC relinquished date/time is completed by the field
personnel and samples are released to the carrier. Samples are only considered to be received
by the laboratory when personnel at the fixed laboratory facility have physical contact with the
samples.
Note: Independent couriers are not required to sign the COC form. The COC is usually kept in
the sealed sample cooler. The receipt from the courier is stored in log-in by date; it lists all
receipts each date.
23.1.2 Legal / Evidentiary Chain-of-Custody
If samples are identified for legal/evidentiary purposes on the COC, standard COC and sample
handling procedures apply. Eurofins EMLab P&K does not provide internal chain of custody.
23.2 Sample Receipt
Samples are received at the laboratory by designated sample receiving personnel and a unique
laboratory project identification number is assigned. Each sample container shall be assigned a
unique sample identification number that is cross-referenced to the client identification number
such that traceability of test samples is unambiguous and documented. Each sample container
is affixed with a durable sample identification label. Sample acceptance, receipt, tracking and
storage procedures are detailed in SOP EM-SM-S-1288, and summarized in the following
sections.
23.2.1 Laboratory Receipt
The integrity of all samples received is checked during the Sample Receipt process outlined in
Document EM-SM-S-1288 "Sample Receipt" prior to sample Log-in. It is the duty of the
individual receiving the samples to ensure that the samples received are intact and not
compromised in any fashion. The sample acceptance policy to be used as a guideline for
assessing the integrity of received samples is contained within Document EM-SM-S-1288
"Sample Receiving".
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During sample receipt and log in, the receiving staff separates the individual analysis types into
bins and makes copies of the original COC for each bin as needed. The types of analyses, the
number of samples received for each analysis, the type of sample and the requested turnaround
time are recorded into the database. Any missing or extra samples received are recorded on the
original COC and into the database. If any of the previous information is missing or incomplete,
the information is documented into the database and the client is contacted. Samples are
categorized by projects and analysis types into individual bins and queued for the Log-in
process. The laboratory maintains a sample storage area that protects the samples from
deterioration, loss, damage or from unauthorized access.
Whenever a compromised sample is encountered, the information is documented in LabServe
(Report Comments, Project Log, Project Tasks, Log-in Field or Account Details). The client must
be contacted and at the very least, if possible, a message left to inform the client of the
situation. If, at the client's request, a compromised sample is analyzed, a qualifying statement
must be submitted with the written report describing that the integrity of the results are
potentially compromised and that the interpretation of the data is left to the client. Clients are
informed on the condition of the sample in the final report. A record of pertinent discussions with
clients must be maintained in LabServe (for example in the account details, project logs, tasks,
etc.).
23.2.1.1 Unique Sample Identification
All samples that are processed through the laboratory receive a unique sample identification to
ensure that there can be no confusion regarding the identity of such samples at any time. This
system includes identification for all samples.
The laboratory assigns a unique identification (e.g., Sample ID) code to each sample container
received at the laboratory.
23.3 Sample Acceptance Policy
The laboratory has a written sample acceptance policy noted in Document EM-SM-S-1288
"Sample Receipt" (Example in Figure 23-2) that clearly outlines the circumstances under which
samples shall be accepted or rejected. These include, but are not limited to:
sample holding times must be adhered to (Sampling Guide);
all samples submitted must have a Chain of Custody (COC), or an equivalent sample
request, to be received by the laboratory;
samples are checked for unique identifiers on each sample and that the number of samples
matches the information on the COC;
proper sample containers with adequate volume for the analysis (Sampling Guide) and
necessary QC;
samples must be preserved according to the requirements of the requested analytical
method (Sampling Guide);
the project manager will be notified if any sample is received in damaged condition.
Data from samples which do not meet these criteria are flagged and the nature of the variation
from policy is defined.
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23.3.1 After inspecting the samples, the sample receiving personnel sign and date the COC
form, make any necessary notes of the samples' conditions and store them in
appropriate refrigerators or storage locations, as needed.
23.3.2 Any deviations from these checks that question the suitability of the sample for analysis,
or incomplete documentation as to the tests required will be resolved by consultation
with the client. If the sample acceptance policy criteria are not met, the laboratory shall
either:
Retain all correspondence and/or records of communications
with the client regarding the disposition of rejected samples, or
Fully document any decision to proceed with sample analysis
that does not meet sample acceptance criteria.
Once sample acceptance is verified, the samples are logged into the LIMS/LabServe according
SOP No. EM-SM-S-1993. and assigned an Eurofins EMLab P&K, LLC Project Number and
unique laboratory identifiers for each sample in the project.
All client information, project information, analysis requests, sample identifier information,
sample descriptions and miscellaneous notes are entered into the database. The information
logged into the database is checked against the information on the original COC and Project
Log before the samples are sent to a Receiving and Log- in Quality Control check.
In an effort to meet the needs of the client, Eurofins EMLab P&K, LLC offers the client the ability
to log samples in via the internet. Clients enter Chain of Custody (COC) information into the
internet log-in screen and then print a COC form which is sent with the samples to the
laboratory.
Upon receipt of the samples at the laboratory the COCs are signed by the receiving laboratory
staff and the information logged in by the clients is compared with the samples received and the
information on the printed client produced COC. Additional information regarding Sample Log In
via the internet can be found in SOP EM-SM-S-1993.
23.4 Sample Storage
In order to avoid deterioration, contamination or damage to a sample during storage and
handling, from the time of receipt until all analyses are complete, samples are stored in
refrigerators, freezers or protected locations suitable for the sample matrix. Samples are never
to be stored with reagents, standards or materials that may create contamination.
Access to the laboratory is controlled such that sample storage need not be locked at all times
unless a project specifically demands it. Samples are accessible to laboratory personnel only.
Visitors to the laboratory are prohibited from entering the refrigerator and laboratory areas
unless accompanied by an employee of Eurofins.
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23.5 Hazardous Samples and Foreign Soils
To minimize exposure to personnel and to avoid potential accidents, hazardous and foreign soil
samples are stored in an isolated area designated for hazardous waste only. For any sample
that is known to be hazardous at the time of receipt or, if after completion of analysis the result
exceeds the acceptable regulatory levels, a Hazardous Sample Notice must be completed by
the analyst. This form may be completed by Sample Control, Project Managers, or analysts and
must be attached to the report. The sample itself is clearly marked with a red stamp, stamped
on the sample label reading “HAZARDOUS” or “FOREIGN SOIL” and placed in a colored and/or
marked bag to easily identify the sample. The date, log number, lab sample number, and the
result or brief description of the hazard are all written on the Hazardous & Foreign Soil Sample
Notice. A copy of the form must be included with the original COC and Work Order and the
original must be given to the Sample Control Custodian. Analysts will notify Sample Control of
any sample determined to be hazardous after completion of analysis by completing a
Hazardous Sample Notice. All hazardous samples are either returned to the client or disposed
of appropriately through a hazardous waste disposal firm that lab-packs all hazardous samples
and removes them from the laboratory. Foreign soil samples are sent out for incineration by a
USDA-approved waste disposal facility.
23.6 Sample Shipping
In the event that the laboratory needs to ship samples, the samples are placed in a cooler with
enough ice where necessary to ensure the samples remain within required temperature range
for desired analysis during transit. The samples are carefully surrounded by packing material to
avoid breakage (yet maintain appropriate temperature where necessary). The chain-of-custody
form is signed by the sample control technician and included in the shipment. Samples are
generally shipped overnight express or hand-delivered by a Eurofins TestAmerica courier to
maintain sample integrity. All personnel involved with shipping and receiving samples must be
trained to maintain the proper chain-of-custody documentation and to keep the samples intact
and on ice, where necessary. The Environmental, Health and Safety Manual contains additional
shipping requirements.
23.7 Sample Disposal
Samples should be retained for a minimum of 30 days after the project report is sent, however,
provisions may be made for earlier disposal of samples once the holding time is exceeded.
Some samples are required to be held for longer periods based on regulatory or client
requirements (e.g., 60 days after project report is sent). The laboratory must follow the longer
sample retention requirements where required by regulation or client agreement. Several
possibilities for sample disposal exist: the sample may be consumed completely during analysis,
the sample may be returned to the customer or location of sampling for disposal, or the sample
may be disposed of in accordance with the laboratory’s waste disposal procedures (SOP EM-
HS-S-1286). All procedures in the laboratory’s Environmental Health and Safety Manual are
followed during disposal. Samples are normally maintained in the laboratory no longer than one
month from receipt unless otherwise requested. Unused portions of samples found or suspected
to be hazardous according to state or federal guidelines may be returned to the client upon
completion of the analytical work.
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Figure 23-1 .Example: Sample Acceptance Policy
All incoming work will be evaluated against the criteria listed below and found with SOP EM-SM-S-1288.
Where applicable, data from any samples that do not meet the criteria listed below will be noted on the
laboratory report defining the nature and substance of the variation. In addition the client will be notified
ASAP after the receipt of the samples.
Per State and/or Federal Regulation, the client is responsible to ensure that samples are shipped in
accordance with DOT/IATA requirements, and that radioactive materials may only be delivered to licensed
facilities. Any samples containing (or suspected to contain) Source, Byproduct, or Special Nuclear
Material as defined by 10 CFR should be delivered directly to facilities licensed to handle such radioactive
material. Natural material or ores containing naturally occurring radionuclides may be delivered to any
Eurofins facility or courier as long as the activity concentration of the material does not exceed 270 pCi/g
alpha or 2700 pCi/g beta (49 CFR Part 173).
Samples received are expected to display the following features:
Sealed correctly to eliminate cross contamination.
Clearly discernible markings and identifications.
Packing materials sufficient to appropriate to eliminate the risk of damage during delivery.
Sample volume/amount must meet minimum and maximum amount requirements for each
analysis, if applicable.
Lead wipes must meet ASTM E1792 criteria.
Culture media within expiration dates and lot numbers clearly identified on the plate.
Asbestos PCM cassettes should not be packaged in Styrofoam and should be separated
from PLM samples.
Bacteriology samples, where a state certification is applicable, should only be shipped to
labs holding that certification and should meet the analysis’ temperature and holding time
requirements.
Samples will be placed on the Project Manager will contact the client if any of the following are
observed:
Leakage from a sample.
Water intrusion into a sample.
Physical damage to a sample due to improper packaging during transport.
Breaking or otherwise discernible compromise to the integrity of the sample.
Illegible, ambiguous, or missing sample identification information.
Sample volume/amount does not meet minimum and maximum amount requirements for
each analysis, if applicable.
Lead wipes do not meet the ASTM E1792 criteria.
Culture media that is expired, dried, or detached from the culture plate.
Asbestos PCM cassettes packaged in Styrofoam or with asbestos bulk samples.
Bacteriology samples submitted for an analysis for which state certification is not held at the
laboratory of receipt, and/or not adhering to the temperature and hold time requirements
Sample and hold time requirements vary per method. These can be found in SOP EM-SM-S-
1288.
Eurofins EMLab P&K will make every effort to analyze samples within the regulatory holding
time. Samples must be received in the laboratory with enough time to perform the sample
analysis. Except for short holding time samples (< 48hr HT) sample must be received with at
least 48 hrs (2 working days) remaining on the holding time for us to ensure analysis.
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24.0 ASSURING THE QUALITY OF TEST RESULTS
24.1 Overview
In order to assure our clients of the validity of their data, the laboratory continuously evaluates
the quality of the analytical process. The analytical process is controlled not only by instrument
calibration as discussed in Section 20, but also by routine process quality control measurements
(e.g. Blanks, Laboratory Control Samples (LCS), Matrix Spikes (MS), duplicates (DUP),
replicates (REP), daily reference slides, and routine quality control checks). These quality
control checks are performed as required by the method or regulations to assess precision and
accuracy. Quality control samples are to be treated in the exact same manner as the
associated field samples being tested. In addition to the routine process quality control
samples, Proficiency Testing (PT) Samples (concentrations unknown to laboratory) are
analyzed to help ensure laboratory performance.
24.2 Controls
Sample preparation or pre-treatment is commonly required before analysis. Typical preparation
steps vary per method and may include homogenization, drying, acid digestion filter concentration,
heat treatment, acid treatment, dilution, centrifugation, etc.. During these pre-treatment steps,
samples are arranged into discreet manageable groups referred to as preparation (prep) batches,
where applicable. Prep batches provide a means to control variability in sample treatment. Control
samples are added to each prep batch to monitor method performance and are processed through
the entire analytical procedure with investigative/field samples.
Quality Control Requirements include, but are not limited to, duplicate analysis, replicate
analysis, daily reference analysis, round robin and proficiency testing as applicable to the
method being performed. Quality control requirements, acceptance criteria, frequency and
required trending practices are outlined in Document EM-QA-S-1994, Quality Control for
Sample Analysis, Document EM-QA-S-1259, Quality Control for Asbestos Analysis, or within
method specific documents.
A Quality Control and Acceptance Criteria Summary is available as Document EM-QA-R-5730.
24.3 Negative Controls
Table 24-1. Example – Negative Controls
Control Type Details
Negative Control
(NC)
are used to assess preparation and analysis for possible contamination during the preparation
and processing steps.
The specific frequency of use for method blanks during the analytical sequence is defined in the
specific standard operating procedure for each analysis. Generally it is 1 per day of analysis.
The method blank is prepared from a clean matrix similar to that of the associated samples that
is free from target analytes (e.g., Reagent water, Ottawa sand, glass beads, etc.) and is
processed along with and under the same conditions as the associated samples.
The method blank goes through all of the steps of the process (including as necessary: filtration,
clean-ups, etc.).
Reanalyze or qualify associated sample results when the concentration of a targeted analyte in
the blank is at or above the reporting limit as established by the method or by regulation, AND is
greater than 1/10 of the amount measured in the sample.
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Table 24-1. Example – Negative Controls
Control Type Details
Calibration
Blanks
are prepared and analyzed along with calibration standards where applicable. They are prepared
using the same reagents that are used to prepare the standards. In some analyses the
calibration blank may be included in the calibration curve.
Instrument Blanks are blank reagents or reagent water that may be processed during an analytical sequence in
order to assess contamination in the analytical system. In general, instrument blanks are used to
differentiate between contamination caused by the analytical system and that caused by the
sample handling or sample prep process. Instrument blanks may also be inserted throughout the
analytical sequence to minimize the effect of carryover from samples with high analyte content.
Field Blanks 1 are sometimes used for specific projects by the field samplers.
1 When known, these field QC samples should not be selected for matrix QC as it does not provide
information on the behavior of the target compounds in the field samples. Usually, the client sample ID
will provide information to identify the field blanks with labels such as "FB", "EB", or "TB."
Evaluation criteria and corrective action for these controls are defined in the specific standard
operating procedure for each analysis.
24.3.1 Negative Controls for Microbiological Methods – Microbiological Methods utilize a variety
of negative controls throughout the process to ensure that false positive results are not
obtained. These controls are critical to the validity of the microbiological analyses. Details of
required negative controls are located within in each method SOP.
Table 24-2. Examples of Negative Controls for Microbiology
Control Type Details
Sterility Checks
(Media)
are analyzed for each lot of pre-prepared media, ready-to-use media and for each batch of
medium prepared by the laboratory.
Sterility checks
(Sample
Containers)
are performed on at least one container per lot of purchased, pre-sterilized containers. If
containers are prepared and sterilized by the laboratory, one container per sterilization
batch is checked. Container sterility checks are performed using non-selective growth
media.
Sterility Checks
(Dilution Water)
are performed on each batch of dilution water prepared by the laboratory and on each batch
of pre-prepared dilution water.
Sterility Checks
(Filters)
are also performed on at least one filter from each new lot of membrane filters using non-
selective growth media.
Negative culture controls demonstrate that a media does not support the growth of non-target
organisms and ensures that there is not an atypical positive reaction from the target organisms.
Prior to the first use of the media, each lot of pre-prepared selective media or batch of laboratory
prepared selective media is analyzed with at least one known negative culture control as
appropriate to the method.
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24.4 Positive Controls
Each regulatory program and each method within those programs specify the control samples
that are prepared and/or analyzed with a specific batch
Note that frequency of control samples vary with specific regulatory, methodology and project
specific criteria. Complete details on method control samples are as listed in each analytical
SOP.
Cultures for quality control testing of media and for use as reference organisms are stored
appropriately based on procedural requirements. Details can be found in EM-AD-S-5745.
24.4.1 Controls for Microbiological Methods
Laboratory produced media and reagents are checked against quality control organisms, where
applicable, and for sterility according to media type recipes/instructions prior to use in analytical
procedures. Documentation for the quality control of media and reagents are kept on file.
Quality Control records for media produced by outside vendors are kept on file.
24.5 Acceptance Criteria (Control Limits)
As mandated by the test method and regulation, each individual QC sample (daily reference,
duplicate, replicate, positive control, negative control, etc.) is evaluated against the control limits
published in the test method. Where there are no established acceptance criteria, the laboratory
calculates in-house control limits with the use of control charts or, in some cases, utilizes client
project specific control limits. When this occurs, the regulatory or project limits will supersede
the laboratory’s in-house limits.
Note:For methods, analytes and matrices with very limited data (e.g., unusual matrices not
analyzed often), interim limits are established using available data or by analogy to similar
methods or matrices.
Once control limits have been established, they are verified, reviewed, and updated if necessary
on a biennial basis unless the method requires more frequent updating. Control limits are
established per method (as opposed to per instrument) regardless of the number of instruments
utilized.
Laboratory generated % Recovery acceptance (control) limits are generally established by
taking + 3 Standard Deviations (99% confidence level) from the average recovery of a minimum
of 20-30 data points (more points are preferred).
Regardless of the calculated limit, the limit should be no tighter than the Calibration
Verification (ICV/CCV) where applicable. (Unless the analytical method specifies a tighter
limit).
In-house limits cannot be any wider than those mandated in a regulated analytical method.
Client or contract required control limits are evaluated against the laboratory’s statistically
derived control limits to determine if the data quality objectives (DQOs) can be achieved. If
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laboratory control limits are not consistent with DQOs, then alternatives must be considered,
such as method improvements or use of an alternate analytical method.
24.5.1 The lab must be able to generate a current listing of their control limits and track when
the updates are performed. In addition, the laboratory must be able to recreate historical control
limits.
24.5.2 A LCS that is within the acceptance criteria establishes that the analytical system is in
control and is used to validate the process. Samples that are analyzed with an LCS with
recoveries outside of the acceptance limits may be determined as out of control and should be
reanalyzed if possible. If reanalysis is not possible, then the results for all affected analytes for
samples within the same batch must be qualified when reported. The internal corrective action
process (see Section 12) is also initiated if an LCS exceeds the acceptance limits. Sample
results may be qualified and reported without reanalysis if:
The analyte results are below the reporting limit and the LCS is above the upper control
limit.
If the analytical results are above the relevant regulatory limit and the LCS is below the
lower control limit.
24.5.3 If the MS/MSDs do not meet acceptance limits, the MS/MSD and the associated spiked
sample is reported with a qualifier for those analytes that do not meet limits. If obvious
preparation errors are suspected, or if requested by the client, unacceptable MS/MSDs are
reprocessed and reanalyzed to prove matrix interference. A more detailed discussion of
acceptance criteria and corrective action can be found in the lab’s method SOPs and in Section
12.
24.6 Additional Procedures to Assure Quality Control
The laboratory has written and approved method SOPs to assure the accuracy of the test
method including calibration (see Section 20), use of certified reference materials (see Section
21) and use of PT samples (see Section 15).
A discussion regarding MDLs, Limit of Detection (LOD) and Limit of Quantitation (LOQ) can be
found in Section 19.
Use of formulae to reduce data is discussed in the method SOPs and in Section 20.
Selection of appropriate reagents and standards is included in Section 9 and 21.
A discussion on selectivity of the test is included in Section 5.
Constant and consistent test conditions are discussed in Section 18.
The laboratories sample acceptance policy is included in Section 23.
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25.0 REPORTING RESULTS
25.1 Overview
The results of each test are reported accurately, clearly, unambiguously, and objectively in
accordance with State and Federal regulations as well as client requirements. Analytical results
are issued in a format that is intended to satisfy customer and laboratory accreditation
requirements as well as provide the end user with the information needed to properly evaluate
the results. Where there is conflict between client requests and laboratory ethics or regulatory
requirements, the laboratory’s ethical and legal requirements are paramount, and the laboratory
will work with the client during project set up to develop an acceptable solution. Refer to Section
9.
A variety of report formats are available to meet specific needs.
In cases where a client asks for simplified reports, there must be a written request from the
client. There still must be enough information that would show any analyses that were out of
conformance (QC out of limits) and there should be a reference to a full report that is made
available to the client. Review of reported data is included in Section 19.
25.2 Test Reports
Analytical results are reported in a format that is satisfactory to the client and meets all
requirements of applicable accrediting authorities and agencies. A variety of report formats are
available to meet specific needs. Data results are predominantly made available to clients
directly through electronic means. Eurofins EMLab P&K, LLC additionally offers hard copy
reporting by special client request only. At a minimum, the standard laboratory report shall
contain the following information:
25.2.1 A report title (e.g., Analytical Report)
25.2.2 The cover page shall include the laboratory name, address and telephone number.
25.2.3 A unique identification of the report (e.g., Eurofins EMLab P&K Project #) and on each
page an identification in order to ensure the page is recognized as part of the report and a clear
identification of the end.
Note:Page numbers of report are represented as page # of ##. Where the first number is
the page number and the second is the total number of pages.
25.2.4 A copy of the chain of custody (COC).
Any COCs involved with Subcontracting are included.
25.2.5 The name and address of client and a project name/number, if applicable.
25.2.6 Description and unambiguous identification of the tested sample(s) including the client
identification code.
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25.2.7 Date of receipt of sample, date and time of collection, and date(s) of test preparation and
performance, and time of preparation or analysis if the required holding time for either activity is
less than or equal to 72 hours.
25.2.8 Date reported or date of revision, if applicable.
25.2.9 Method of analysis including method code (EPA, Standard Methods, etc.).
25.2.10 Reporting limits, where applicable
25.2.11 Method detection limits (if requested)
25.2.12 Definition of Data qualifiers and reporting acronyms (e.g. ND).
25.2.13 Sample results.
25.2.14 Condition of samples at receipt.
25.2.15 A statement to the effect that the results relate only to the items tested and the
sample as received by the laboratory, except when information is provided by the client. When
data is provided by the client there shall be a clear identification of it, and a disclaimer shall be
put in the report when the client supplied data can affect the validity of the test.
25.2.16 A statement that the report shall not be reproduced except in full, without prior
express written approval by the laboratory.
25.2.17 A signature and title of the person(s) accepting responsibility for the content of the
report and date of issue.
25.2.18 When TNI accreditation is required, the lab shall certify that the test results meet all
requirements of TNI or provide reasons and/or justification if they do not.
25.2.19 Appropriate laboratory certification number for the state of origin of the sample, if
applicable.
25.2.20 If only part of the report is provided to the client (client requests some results before
all of it is complete), it must be clearly indicated on the report (e.g., preliminary report). A
complete report must be sent once all of the work has been completed.
25.2.21 Any non- Eurofins EMLab P&K subcontracted analysis results are provided as a
separate report on the official letterhead of the subcontractor. All Eurofins TestAmerica
subcontracting is clearly identified on the report as to which laboratory performed a specific
analysis.
Note: Refer to Eurofins EMLab P&K SOP EM-QA-2059 for details on internally applying
electronic signatures of approval.
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25.2.22 Electronic Data Deliverables (EDDs)
EDDs are routinely offered as part of Eurofins Eurofins EMLab P&K’s services in addition to the
test report as described in Section 25.2. When NELAP accreditation is required and both a test
report and EDD are provided to the client, the official version of the test report will be the
combined information of the report and the EDD. Eurofins EMLab P&K offers a variety of EDD
formats including Excel and custom files.
EDD specifications are submitted to the IT department by the PM for review and undergo the
contract review process. Once the facility has committed to providing data in a specific
electronic format, the coding of the format may need to be performed. This coding is
documented and validated. The validation of the code is retained by the IT staff coding the
EDD.
EDDs shall be subject to a review to ensure their accuracy and completeness. If EDD
generation is automated, review may be reduced to periodic screening if the laboratory can
demonstrate that it can routinely generate that EDD without errors. Any revisions to the EDD
format must be reviewed until it is demonstrated that it can routinely be generated without
errors. If the EDD can be reproduced accurately and if all subsequent EDDs can be produced
error-free, each EDD does not necessarily require a review.
25.3 Supplemental Information for Test
The lab identifies any unacceptable QC analyses or any other unusual circumstances or
observations such as environmental conditions and any non-standard conditions that may have
affected the quality of a result. This is typically in the form of a footnote or a qualifier and/or a
report comment explaining the discrepancy in the front of the report.
Numeric results with values outside of the calibration range, either high or low are qualified as
estimated.
Where quality system requirements are not met, a statement of compliance/non-compliance
with requirements and/or specifications is required, including identification of test results derived
from any sample that did not meet TNI sample acceptance requirements such as improper
container, holding time, or temperature.
Where applicable, a statement on the estimated uncertainty of measurements; information on
uncertainty is needed when a client’s instructions so require.
When, as requested by the client and agreed to by Eurofins EMLab P&K, the report includes a
statement of conformity to specification or standard (see Special Services, Section 7.4), the
report shall clearly identify:
to which results the statement applies,
which specifications, standard or parts thereof are met or not, and
the decision rule that was applied (unless the decision rule is inherent in the requested
specification or standard, taking into account the level of risk (such as false accept and false
reject and statistical assumptions) associated with the decision rule.
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Opinions and Interpretations - The test report contains objective information, and generally does
not contain subjective information such as opinions and interpretations. If such information is
required by the client, the Laboratory Director will determine if a response can be prepared. If
so, the Laboratory Director will designate the appropriate member of the management team to
prepare a response. The response will be fully documented, and reviewed by the Laboratory
Director, before release to the client. There may be additional fees charged to the client at this
time, as this is a non-routine function of the laboratory.
Note: Review of data deliverable packages for submittal to regulatory authorities requires
responses to non-conforming data concerning potential impact on data quality. This
necessitates a limited scope of interpretation, and this work is performed by the QA Department.
This is the only form of “interpretation” of data that is routinely performed by the laboratory.
When opinions or interpretations are included in the report, the laboratory provides an
explanation as to the basis upon which the opinions and interpretations have been made.
Opinions and interpretations are clearly noted as such and where applicable, a comment should
be added suggesting that the client verify the opinion or interpretation with their regulator.
25.4 Environmental Testing Obtained From Subcontractors
If the laboratory is not able to provide the client the requested analysis, the samples would be
subcontracted following the procedures outlined in the Eurofins EMLab P&K SOP on
Subcontracting (SOP No. EM-SM-S-1288).
Data reported from analyses performed by a subcontractor laboratory are clearly identified as
such on the analytical report provided to the client. Results from a subcontract laboratory
outside of Eurofins EMLab P&K are reported to the client on the subcontract laboratory’s
original report stationary and the report includes any accompanying documentation.
25.5 Client Confidentiality
The laboratory will ensure the highest standards of quality and integrity of the data and services
provided to our clients.
The laboratory is responsible for maintaining in confidence all client information obtained or
created. In situations involving the transmission of environmental test results by telephone,
facsimile or other electronic means, client confidentiality must be maintained.
The laboratory will not intentionally divulge to any person (other than the client or any other
person designated by the client in writing) any information regarding the services provided by
the laboratory or any information disclosed to the laboratory by the client. Furthermore,
information known to be potentially endangering to national security or an entity’s proprietary
rights will not be released.
Should it be necessary to place any client information in a public domain, the customer shall be
informed in advance, unless the client already provides the same information publically and/or
has agreed to the release by the laboratory.
Information about the client obtained from sources other than the client (e.g., complainant,
regulators) shall be confidential between client and the laboratory. The source of this
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information shall be confidential to the laboratory and shall not be shared with the client, unless
agreed by the source.
Note:This shall not apply to the extent that the information is required to be disclosed by
the laboratory under the compulsion of legal process. The laboratory will, to the extent feasible,
provide reasonable notice to the client before disclosing the information.
Note:Authorized representatives of an accrediting authority are permitted to make copies
of any analyses or records relevant to the accreditation process, and copies may be removed
from the laboratory for purposes of assessment.
25.5.1 Report deliverable formats are discussed with each new client. If a client requests that
reports be faxed or e-mailed, the reports are to meet all requirements of this document,
including cover letter.
25.6 Format of Reports
The format of reports is designed to accommodate each type of environmental test carried out
and to minimize the possibility of misunderstanding or misuse.
25.7 Amendments to Test Reports
Corrections, additions, or deletions to reports are only made when justification arises through
supplemental documentation. Justification is documented using the laboratory’s corrective
action system (refer to Section 12).
The revised report is retained in the LIMS/LabServe, under the “Deliverables” section of the
project details page. The original report is maintained in the LIMS/LabServe, under the
“Reports” section of the project details page. The revised report will have the word “revised” or
“amended” on the report cover page and a unique report ID in LabServe. The ”Delivery” section
of the project details page in the LIMS/LabServe provides a delivery record of reports and
packages.
When the report is re-issued, a notation of “revised report“ is placed on the cover/signature
page of the report with a brief explanation of reason for the re-issue.
25.8 Policies on Client Requests for Amendments
25.8.1 Policy on Data Omissions or Reporting Limit Increases
Fundamentally, our policy is simply to not omit previously reported results (including data
qualifiers) or to not raise reporting limits and report sample results as ND. This policy has few
exceptions. Exceptions are:
Laboratory error.
Sample identification is indeterminate (confusion between COC and sample labels).
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An incorrect analysis (not analyte) was requested (e.g., COC lists 8315 but client wanted
8310). A written request for the change is required.
Incorrect limits reported based on regulatory requirements.
The requested change has absolutely no possible impact on the interpretation of the
analytical results and there is no possibility of the change being interpreted as
misrepresentation by anyone inside or outside of our company.
25.8.2 Multiple Reports
Eurofins EMLab P&K does not issue multiple reports for the same work order where there is
different information on each report (this does not refer to copies of the same report) unless
required to meet regulatory needs and approved by QA.
26.0 ACCREDITATION AND LOGO ADVERTISING POLICY
26.1 Eurofins EMLab P&K, LLC strives to comply with the advertising and logo requirements of
all external licensing/accrediting bodies. As such, the accreditation and logo advertising polices
of all external licensing/accrediting bodies (i.e. NIST NVLAP, AIHA-LAP, LLC EMLAP and
ELLAP, IHLAP, TCEQ, and NYS DOH programs etc.) must be reviewed and all conditions
adhered to prior to use in advertising and/or reporting.
26.1.1 When the external licensing/accrediting bodies term is used to reference a laboratory’s
accredited status, it shall be accompanied by the external licensing/accrediting bodies
lab code, where applicable.
26.1.2 The logos are on the Eurofins EMLab P&K website and some marketing material and
not used on reports.
26.1.3 A test report bearing the term and/or symbol shall include a statement that the report
must not be used by the client to claim product certification, approval, or endorsement by
any external licensing/accrediting bodies or agency of the U.S. Government.
26.1.4 A laboratory shall not use the terms certified or registered when referencing its
accreditations or conformance to current ISO/IEC 17025 requirements. The correct term
is accredited.
26.1.5 When an accredited laboratory uses the term and/or symbol in a contract or proposal,
the laboratory shall reference its current accreditation status and provide a copy of, or
link to its scope of accreditation.
26.1.6 The external licensing/accrediting body’s symbol shall stand by itself and shall not be
combined with any other logo, symbol, or graphic.
26.1.7 All use of external licensing/accrediting body logos and accreditation information in
advertising or otherwise distributed material must be pre-approved by the management
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team (Cluster Leaders and Quality Assurance) to ensure adherence to the advertising
and logo requirements of all external licensing/accrediting bodies, as noted in 26.1
above.
27.0 REVISION HISTORY
27.1 For access and review of previous Quality Assurance Manual revisions, contact Quality
Assurance.
27.2 Revision 10, December 2015
27.2.1 Updated laboratory information for Chicago, Florida and South San Francisco, Added
laboratory information for Atlanta (cover page).
27.2.2 Updated Technical Mangers for Irvine, South San Francisco, Sacramento, Seattle and
Las Vegas. Added Technical Manager for Atlanta. (cover page).
27.2.3 Added responsibility for resumption of work for a stop work directive. (section 2.1.8 and
9.4).
27.2.4 Updated analytical method review frequency to biennially in the QA Manager job
description (section 3.3.2)
27.2.5 Removed reference to “Lean Manager” in Project Manager job description (section
3.5.3).
27.2.6 Replaced term AIHA with AIHA-LAP, LLC throughout the document.
27.2.7 Corrected NVLAP acronym (section 3.6.4, 3.7.4 and 3.8.4).
27.2.8 Updated glassware washing requirements to “reusable” glassware (section 4.9)
27.2.9 Switched assigning the unique laboratory identification n umber from sample receipt
procedure to login procedure (sections 5.3 and 5.4).
27.2.10 Removed records and control chats from controlled document section to records.
(section 7.0 and 7.4)
27.2.11 Updated procedure for obsolete documents (section 7.15)
27.2.12 Added a monthly minimum requirement for QC blind recounts (section 8.2).
27.2.13 Added option for non-proficiency testing data for use in creating demonstrations of
capability (section 12.4)
27.2.14 Updated requirements for PLM round robin analysis, (section 12.5.3).
27.2.15 Updated requirements for asbestos environmental monitoring (section 13.0)
27.2.16 Updated South San Francisco floor plan
27.2.17 Revised Organizational chart format to remove names (section 19.5).
27.3 Revision 11, November 2016
27.3.1 Updated contact information for western region QA Manager on cover page.
27.3.2 Updated Las Vegas laboratory address on cover page.
27.3.3 Updated Technical Mangers for Irvine and, Sacramento on cover page.
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27.3.4 Added Atlanta AIHA-LAP, LLC Laboratory ID number and removed "approved signatory"
from Technical Managers signature on cover page
27.3.5 Moved statement marked in 1.1.1 to 1.1.2
27.3.6 Added statement that QA Manual confirms to CQMP in section 1.1.2.
27.3.7 Added reference to scopes of accreditation and added lead as an analytical technique in
section 1.2.1
27.3.8 Added "NYS DOH" to sections 2.1.1 and 16.1
27.3.9 Added job description for ELLAP Technical Manager and updated job description for
Analyst and Laboratory Technician in sections 3.7.2.g, 3.7.4.c.i, 3.8.2.j and 3.11.
27.3.10 Changed "calibration" to "verification" in section 4.4.2
27.3.11 Updated section 4.8.2 to reflect current annual schedule for non-BSC hood
calibrations
27.3.12 Added suggested addition of COC under "contract review" in section 6.2.1
27.3.13 Added reference to EMLab P&K signature policy CA-I-P-002 in section 7.3.3
27.3.14 Updated record retention policy for all documents relating to AIHA_LAP, LLC ELLAP
and NYS-DOH in section 7.4.2
27.3.15 Updated record retention policy for training documents relating to AIHA_LAP, LLC
ELLAP and NYS-DOH in section 7.4.3
27.3.16 Updated computer back-up storage policy in section 7.5.6
27.3.17 Added requirement for client notification of where client data has been affected must
be made within two weeks of completing investigation in section 9.4.1
27.3.18 Added requirement for environmental monitoring for lead to section 13.1.1
27.3.19 Updated the accreditation logo and name policy in section 16.0.
27.3.20 Replaced "QAzilla" with "corrective action request" in sections referencing work out of
spec or corrective actions, etc.
27.4 Revision 12, March 2017
27.4.1 Updated Western and Central Regional Director name on cover page.
27.4.2 Updated EMLAP, IHLAP and ELLAP Technical Manager requirements.
27.4.3 Added that reporting limits are listed on final reports where applicable in section 5.11
27.4.4 Added if available to the requirement for NIST reference materials in section 12.8.2.c.
27.5 Revision 13, May 2018
27.5.1 QA Manual template conversion from EMLab P&K template to TestAmerica corporate
template/structure.
27.5.2 Addition of lab manager role in personnel section
27.5.3 Addition of notification requirements for laboratory changes.
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27.6 Revision 14, September 2018
27.6.1 Revision updates to address changes related to ISO 17025:2017 updates
27.6.2 Restoration of “Accreditation and Logo Advertising Policy”
27.7 Revision 15, September 2019
27.7.1 Revision updates to address rebranding to Eurofins TestAmerica and Eurofins EMLab
P&K
27.7.2 Removal of Technical Manager approval requirements for annual QA Manual revision in
Sec. 3.4.1.
27.7.3 Sec. 18.2 - Added paragraph 6 regarding the requirement concerning management of
environmental conditions when work is being performed offsite.
27.7.4 Sec. 20.3.1, Correction to working weight verification schedule.
27.7.5 Updated Table 20-1 to reflect updated calibration frequency for biological safety
cabinets.
27.7.6 Updated Org charts, Figure 4-1
27.7.7 Updated Revision History section to reflect and support technical record retention period.
27.8 Revision 16, October 2020
27.8.1 Revision updates to address continued rebranding, and updating references to
‘corporate’ as “NDSC’
27.8.2 Revisions to address changes to NDSC QAM template guidance, including section re-
organization, table relocations to appendices.
27.8.3 Revisions to update Org Charts.
27.8.4 Removal of floor plans.
27.8.5 Added Section 4.1.1, Selection of Personnel
27.8.6 Addition of Section 4.3.10 for combined QA Assistant / EHSC role
27.8.7 Revisions to address deployment of personnel in additional network facilities, Sections
5.1, 5.3, and 17.1.5.
27.8.8 Revisions to address risks and opportunities in Section 14.3.2
27.8.9 Revisions to clarify processes for vendor/supplier evaluations, purchasing.
27.8.10 Revisions to include policy on deployment of analysts across network facilities, as well
as related policies on PT participation.
27.8.11 Update to Client Confidentiality, Section 25.5 to include notification for information in
public domains.
27.8.12 Reference QAzilla # 11048 for revision/approval process details.
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Appendix 1.
List of Governing Documents applicable to the QA Manual
(NDSC, KDG and Laboratory SOPs and Policies)
NDSC Doc. No.Title
CA-C-S-001 Work Sharing Process
CA-I-P-002 Electronic Reporting and Signature Policy
CA-L-P-002 Contract Compliance Policy
CA-Q-M-002 Corporate Quality Management Plan
CA-Q-S-001 Acid and Solvent Lot Testing and Approval Program
CA-Q-S-002 Manual Integrations
CA-Q-S-006 Detection and Quantitation Limits
CA-Q-S-009 Root Cause Analysis
CA-T-P-001 Qualified Products List
CW-E-M-001 Corporate Environmental Health & Safety Manual
CW-F-P-002 Company-Wide Authorization Matrix
CW-F-P-004 Procurement and Contracts Policy
CW-F-S-007 Fixed Asset Acquisition, Retention and Safeguarding
CW-I-M-001 IT Change Control Procedure Manual
CW-L-P-001 Records Retention Policy
CW-L-P-004 Ethics Policy
CW-L-S-002 Internal Investigation
CW-Q-S-001 Corporate Document Control and Archiving
CW-Q-S-002 Writing a Standard Operating Procedure (SOPs)
CW-Q-S-003 Internal Auditing
CW-Q-S-004 Management Systems Review
CW-Q-S-005 Data Recall Process
CW-Q-S-001 Corporate Document Control and Archiving
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Referenced Laboratory SOPs
Eurofins EMLab P&K
Doc. No.
Title
EM-QA-S-2059 Document Control & Updating (Document Control and Control of
Records, Sec. 3.4.1)
EM-CS-S-1709 Complaint Resolution (Resolving Client Concerns and Soliciting
Client Feedback, Sec .10.1)
EM-QA-S-2059 Data Scanning (Document Control and Control of Records – Sec.
14.1.4)
EM-AD-S-1646
EM-AD-S-1261
Lab Training (General Training, Asbestos Analysis Training, Sec.
17.3)
EM-QA-S-2059 Writing SOPs (Document Control and Control of Records, Sec.
19.2)
EM-AD-S-1646
EM-AD-S-3548
EM-AD-S-1619
DOCs (General Training, Selection and Validation of Analytical
Methods, Nonstandard Methods for Analysis Sec. 19.4.2)
EM-QA-S-1994
EM-QA-S-1259
MDLs (Quality Control for Sample Analysis, Quality Control for
Asbestos Analysis, Sec. 19.7)
EM-AD-S-1601
EM-AD-S-1884
MI (Laboratory Service Management, QAzilla and LabServe
Enhancement Procedure, Sec. 19.14.1)
EM-SM-S-1288
EM-SM-S-1993
Sample Receipt / Login, etc… (Sample Receiving, Sample Log In,
Sec. 23.2.1.3)
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Appendix 2.
Laboratory Certifications, Accreditations, Validations
Eurofins EMLab P&K maintains accreditations, certifications, and approvals with numerous
state and national entities. Programs vary but may include on-site audits, reciprocal
agreements with another entity, performance testing evaluations, review of the QA Manual,
Standard Operating Procedures, Method Detection Limits, training records, etc. Details of
accreditation/ certification/licensing, including accredited parameter lists are available for each
program at www.emlab.com under ”Accreditations”.
Appendix 3.
References used to prepare the QA Manual
The QAM has been prepared to be consistent with the requirements of the following documents:
ANSI/ASQC, E4-1994, “Specifications and Guidelines for Quality Management Systems for
Environmental Data Collection and Environmental Technology Programs” (American National
Standard, January 5, 1995, or most recent version)
“EPA Requirements for Quality Management Programs” (QA/R-2) (EPA/240/B-01/002, May 31, 2006).
EPA 600/4-79-019, Handbook for Analytical Quality Control in Water and Wastewater Laboratories,
EPA, March 1979.
Test Methods for Evaluating Solid Waste Physical/Chemical Methods (SW846), Third Edition,
September 1986, Final Update I, July 1992, Final Update IIA, August 1993, Final Update II,
September 1994; Final Update IIB, January 1995; Final Update III, December 1996; Final Update IV,
January 2008; Final Update V, August 2015.
Federal Register, 40 CFR Parts 136, 141, 172, 173, 178, 179 and 261.
Manual for the Certification of Laboratories Analyzing Drinking Water (EPA 815-R-05-004, January
2005) (DW labs only)
APHA, Standard Methods for the Examination of Water and Wastewater, 18th Edition, 19th, 20th, 21st,
22nd and on-line Editions.
Marine Protection, Research, and Sanctuaries Act (MPRSA).
Toxic Substances Control Act (TSCA).
AIHA-LAP, LLC Accreditation Policy Modules,Rev 14
NIST NVLAP Handbooks 150, Procedures and General Requirements (2020) and 150-3, Bulk
Asbestos Analysis (2018-07)
Appendix 4.
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Glossary/Acronyms (EL-V1M2 Sec. 3.1)
Glossary:
Acceptance Criteria: Specified limits placed on characteristics of an item, process, or service defined in
requirement documents. (ASQC)
Accreditation: The process by which an agency or organization evaluates and recognizes a laboratory
as meeting certain predetermined qualifications or standards, thereby accrediting the laboratory.
Accuracy: The degree of agreement between an observed value and an accepted reference value.
Accuracy includes a combination of random error (precision) and systematic error (bias) components
which are due to sampling and analytical operations; a data quality indicator. (QAMS)
Analyst: The designated individual who performs the “hands-on” analytical methods and associated
techniques and who is the one responsible for applying required laboratory practices and other pertinent
quality controls to meet the required level of quality.
Analytical Uncertainty: A subset of Measurement Uncertainty that includes all laboratory activities
performed as part of the analysis. (TNI)
Anomaly: A condition or event, other than a non-conformance, that may affect the quality of the data,
whether in the laboratory’s control or not.
Asbestos Definitions
Limit of Quantitation: The Limit of Quantitation is 1%.
Less than One Percent (<1%): When the Laboratory reports a value of <1% using Calibrated Visual
Area Estimation, this indicates that asbestos is present in an amount between trace and 0.99%, but
cannot be accurately quantified at that level unless a 400 Point Count is performed.
Non-Detected (ND): The Laboratory reports “Non-Detected” when the laboratory homogenizes the
sample in some way or analyzes a sufficient number of sub-samples to obtain a representative
analysis whereby no asbestos fibers have been detected in any sub-sample preparations
Trace: When reporting the results of asbestos analyses using Calibrated Visual Area Estimation that
are below the Laboratory’s Limit of Quantitation, the Laboratory does not refer to or use the term
“Trace”; the Laboratory reports the results as <1%. However, on occasion, samples can contain a
“Trace” amount of asbestos. The term “Trace” means that asbestos was found to be present in the
sample, but at a level below the minimum concentration needed to quantify at the reporting limit of
0.25% via a 400 Point Count (performed only by client request).
Assessment: The evaluation process used to measure or establish the performance, effectiveness, and
conformance of an organization and/or its systems to defined criteria (to the standards and requirements
of laboratory accreditation). (TNI)
Audit: A systematic and independent examination of facilities, equipment, personnel, training,
procedures, record-keeping, data validation, data management, and reporting aspects of a system to
determine whether QA/QC and technical activities are being conducted as planned and whether these
activities will effectively achieve quality objectives. (TNI)
Batch: Environmental samples that are prepared and/or analyzed together with the same process and
personnel, using the same lot(s) of reagents. A preparation batch is composed of one (1) to twenty (20)
environmental samples of the same quality systems matrix, meeting the above mentioned criteria and
with a maximum time between the start of processing of the first and last sample in the batch to be
twenty-four (24) hours. An analytical batch is composed of prepared environmental samples (extracts,
digestates or concentrates) which are analyzed together as a group. An analytical batch can include
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prepared samples originating from various quality system matrices and can exceed twenty (20) samples.
(TNI)
Bias: The systematic or persistent distortion of a measurement process, which causes errors in one
direction (i.e., the expected sample measurement is different from the sample’s true value). (TNI)
Blank: A sample that has not been exposed to the analyzed sample stream in order to monitor
contamination during sampling, transport, storage or analysis. The blank is subjected to the usual
analytical and measurement process to establish a zero baseline or background value and is sometimes
used to adjust or correct routine analytical results. (ASQC)
Calibration: A set of operations that establish, under specified conditions, the relationship between
values of quantities indicated by a measuring instrument or measuring system, or values represented by
a material measure or a reference material, and the corresponding values realized by standards. (TNI)
1) In calibration of support equipment the values realized by standards are established through the
use of reference standards that are traceable to the International System of Units (SI).
2) In calibration according to methods, the values realized by standards are typically established
through the use of Reference Materials that are either purchased by the laboratory with a certificate of
analysis or purity, or prepared by the laboratory using support equipment that has been calibrated or
verified to meet specifications.
Calibration Curve: The mathematical relationship between the known values, such as concentrations, of
a series of calibration standards and their instrument response. (TNI)
Calibration Standard: A substance or reference material used to calibrate an instrument (QAMS)
Certified Reference Material (CRM): A reference material accompanied by a certificate, having a value,
measurement uncertainty, and stated metrological traceability chain to a national metrology institute. (TNI)

Chain of Custody (COC) Form: Record that documents the possession of the samples from the time of
collection to receipt in the laboratory. This record generally includes: the number and types of containers;
the mode of collection; the collector; time of collection; preservation; and requested analyses. (TNI)
Compromised Samples: Those samples which are improperly sampled, insufficiently documented
(chain of custody and other sample records and/or labels), improperly preserved, collected in improper
containers, or exceeding holding times when delivered to a laboratory. Under normal conditions,
compromised samples are not analyzed. If emergency situation require analysis, the results must be
appropriately qualified.
Confidential Business Information (CBI): Information that an organization designates as having the
potential of providing a competitor with inappropriate insight into its management, operation or products.
TNI and its representatives agree to safeguard identified CBI and to maintain all information identified as
such in full confidentiality.
Confirmation: Verification of the identity of a component through the use of an approach with a different
scientific principle from the original method. These may include, but are not limited to Second Column
Confirmation; Alternate wavelength; Derivatization; Mass spectral interpretation; Alternative detectors or
Additional Cleanup procedures. (TNI)
Conformance: An affirmative indication or judgment that a product or service has met the requirements
of the relevant specifications, contract, or regulation; also the state of meeting the requirements.
(ANSI/ASQC E4-1994)
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Correction: Actions necessary to correct or repair analysis specific non-conformances. The acceptance
criteria for method specific QC and protocols as well as the associated corrective actions. The analyst
will most frequently be the one to identify the need for this action as a result of calibration checks and QC
sample analysis. No significant action is taken to change behavior, process or procedure.
Corrective Action: The action taken to eliminate the causes of an existing nonconformity, defect or other
undesirable situation in order to prevent recurrence. (ISO 8402)
Daily Reference: A reference sample with a known or accepted quantity of analyte(s) of interest used as
a daily calibration standard to verify accuracy.
Data Audit: A qualitative and quantitative evaluation of the documentation and procedures associated
with environmental measurements to verify that the resulting data re of acceptable quality (i.e., that they
meet specified acceptance criteria).
Data Reduction: The process of transforming the number of data items by arithmetic or statistical
calculations, standard curves, and concentration factors, and collation into a more useable form. (TNI)
Deficiency/ Non-conformance: An unauthorized deviation from acceptable procedures or practices, or
a defect in an item (ASQC), whether in the laboratory’s control or not.
Demonstration of Capability: A procedure to establish the ability of the analyst to generate analytical
results of acceptable accuracy and precision. (TNI)
Document Control: The act of ensuring that documents (and revisions thereto) are proposed, reviewed
for accuracy, approved for release by authorized personnel, distributed properly, and controlled to ensure
use of the correct version at the location where the prescribed activity if performed. (ASQC)
Duplicate Analyses: The analyses or measurements of the variable of interest performed identically on
two subsamples of the same sample. The results from duplicate analyses are used to evaluate analytical
or measurement precision but not the precision of sampling, preservation or storage internal to the
laboratory. (EPA-QAD)
Equipment Blank: Sample of analyte-free media which has been used to rinse common sampling
equipment to check effectiveness of decontamination procedures.
External Standard Calibration: Calibrations for methods that do not utilize internal standards to
compensate for changes in instrument conditions.
Field Blank: Blank prepared in the field by filing a clean container with pure de-ionized water and
appropriate preservative, if any, for the specific sampling activity being undertaken (EPA OSWER)
Field of Accreditation: Those matrix, technology/method, and analyte combinations for which the
accreditation body offers accreditation.
Holding Times: The maximum time that samples may be held prior to analyses and still be considered
valid or not compromised. (40 CFR Part 136)
Internal Standard: A known amount of standard added to a test portion of a sample as a reference for
evaluating and controlling the precision and bias of the applied analytical test method. (TNI)
Internal Standard Calibration: Calibrations for methods that utilize internal standards to compensate for
changes in instrument conditions.
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Instrument Blank: A clean sample (e.g., distilled water) processed through the instrumental steps of the
measurement process; used to determine instrument contamination. (EPA-QAD)
Instrument Detection Limit (IDL): The minimum amount of a substance that can be measured with a
specified degree of confidence that the amount is greater than zero using a specific instrument. The IDL is
associated with the instrumental portion of a specific method only, and sample preparation steps are not
considered in its derivation. The IDL is a statistical estimation at a specified confidence interval of the
concentration at which the relative uncertainty is + 100%. The IDL represents a range where qualitative
detection occurs on a specific instrument. Quantitative results are not produced in this range.
Laboratory Control Sample (however named, such as laboratory fortified blank, spiked blank, or
QC check sample): A sample matrix, free from the analytes of interest, spiked with verified known
amounts of analytes or a material containing known and verified amounts of analytes, taken through all
preparation and analysis steps of the procedure unless otherwise noted in a reference method. It is
generally used to establish intra-laboratory or analyst specific precision and bias or to assess the
performance of all or a portion of the measurement system.
An LCS shall be prepared at a minimum of 1 per batch of 20 or less samples per matrix type per sample
extraction or preparation method except for analytes for which spiking solutions are not available such as
total suspended solids, total dissolved solids, total volatile solids, total solids, pH, color, odor, temperature,
dissolved oxygen or turbidity. The results of these samples shall be used to determine batch acceptance.
Least Squares Regression (1st Order Curve): The least squares regression is a mathematical
calculation of a straight line over two axes. The y axis represents the instrument response (or Response
ratio) of a standard or sample and the x axis represents the concentration. The regression calculation will
generate a correlation coefficient (r) that is a measure of the "goodness of fit" of the regression line to the
data. A value of 1.00 indicates a perfect fit. In order to be used for quantitative purposes, r must be
greater than or equal to 0.99 for organics and 0.995 for inorganics.
Limit(s) of Detection (LOD) [a.k.a., Method Detection Limit (MDL)]: The MDL is the minimum
measured quantity of a substance that can be reported with 99% confidence that the concentration is
distinguishable from method blank results, consistent with 40CFR Part 136 Appendix B, August, 2017.
Limit(s) of Quantitation (LOQ) [a.k.a., Reporting Limit]: The minimum levels, concentrations, or
quantities of a target variable (e.g., target analyte) that can be reported with a specified degree of
confidence.
(QS) Matrix: The component or substrate that contains the analyte of interest. For purposes of batch
and QC requirement determinations, the following matrix distinctions shall be used:
Aqueous: Any aqueous sample excluded from the definition of Drinking Water or
Saline/Estuarine. Includes surface water, groundwater effluents, and TCLP or other extracts.
Drinking Water: Any aqueous sample that has been designated as a potable or potential potable
water source.
Saline/Estuarine: Any aqueous sample from an ocean or estuary, or other salt water source such
as the Great Salt Lake.
Non-Aqueous Liquid: Any organic liquid with <15% settleable solids.
Biological Tissue: Any sample of a biological origin such as fish tissue, shellfish, or plant
material. Such samples shall be grouped according to origin.
Solids: Includes soils, sediments, sludges, and other matrices with >15% settleable solids.
Chemical Waste: A product or by-product of an industrial process that results in a matrix not
previously defined.
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Air & Emissions: Whole gas or vapor samples including those contained in flexible or rigid wall
containers and the extracted concentrated analytes of interest from a gas or vapor that are
collected with a sorbant tube, impinger solution, filter, or other device. (TNI)
Matrix Spike (spiked sample or fortified sample): A sample prepared, taken through all sample
preparation and analytical steps of the procedure unless otherwise noted in a referenced method, by
adding a known amount of target analyte to a specified amount of sample for which an independent test
result of target analyte concentration is available. Matrix spikes are used, for example, to determine the
effect of the matrix on a method's recovery efficiency.
Matrix Spike Duplicate (spiked sample or fortified sample duplicate): A replicate matrix spike
prepared and analyzed to obtain a measure of the precision of the recovery for each analyte.
Method Blank: A sample of a matrix similar to the batch of associated samples (when available) that is
free from the analytes of interest and is processed simultaneously with and under the same conditions as
samples through all steps of the analytical procedures, and in which no target analytes or interferences
are present at concentrations that impact the analytical results for sample analyses.
Method Detection Limit: See Limit of Detection (LOD)
Negative Control: Measures taken to ensure that a test, its components, or the environment do not
cause undesired effects, or produce incorrect test results.
Non-conformance: An indication, judgment, or state of not having met the requirements of the relevant
specifications, contract, or regulation.
Observation: A record of phenomena that (1) may assist in evaluation of the sample data; (2) may be of
importance to the project manager and/or the client, and yet not at the time of the observation have any
known effect on quality.
Performance Audit: The routine comparison of independently obtained qualitative and quantitative
measurement system data with routinely obtained data in order to evaluate the proficiency of an analyst
or laboratory.
Positive Control: Measures taken to ensure that a test and/or its components are working properly and
producing correct or expected results from positive test subjects.
Precision: The degree to which a set of observations or measurements of the same property, obtained
under similar conditions, conform to themselves; a data quality indicator. Precision is usually expressed
as standard deviation, variance or range, in either absolute or relative terms. (TNI)
Preservation: Any conditions under which a sample must be kept in order to maintain chemical and/or
biological integrity prior to analysis. (TNI)
Proficiency Testing: A means of evaluating a laboratory’s performance under controlled conditions
relative to a given set of criteria through analysis of unknown samples provided by an external source.
(TNI)
Proficiency Testing Program: The aggregate of providing rigorously controlled and standardized
environmental samples to a laboratory for analysis, reporting of results, statistical evaluation of the results
and the collective demographics and results summary of all participating laboratories. (TNI)
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Proficiency Test Sample (PT): A sample, the composition of which is unknown to the laboratory and is
provided to test whether the laboratory can produce analytical results within specified acceptance criteria.
(TNI)
Quality Assurance: An integrated system of management activities involving planning, implementation,
assessment, reporting and quality improvement to ensure that a process, item or service is of the type of
quality needed and expected by the client. (TNI)
Quality Assurance [Project] Plan (QAPP): A formal document describing the detailed quality control
procedures by which the quality requirements defined for the data and decisions pertaining to a specific
project are to be achieved. (EAP-QAD)
Quality Control: The overall system of technical activities that measures the attributes and performance
of a process, item, or service against defined standards to verify that they meet the stated requirements
established by the customer; operational techniques and activities that are used to fulfill requirements for
quality; also the system of activities and checks used to ensure that measurement systems are
maintained within prescribed limits, providing protection against “out of control” conditions and ensuring
that the results are of acceptable quality. (TNI)
Quality Control Sample: A sample used to assess the performance of all or a portion of the
measurement system. One of any number of samples, such as Certified Reference Materials, a quality
system matrix fortified by spiking, or actual samples fortified by spiking, intended to demonstrate that a
measurement system or activity is in control. (TNI)
Quality Manual: A document stating the management policies, objectives, principles, organizational
structure and authority, responsibilities, accountability, and implementation of an agency, organization, or
laboratory, to ensure the quality of its product and the utility of its product to its users. (TNI)
Quality System: A structured and documented management system describing the policies, objectives,
principles, organizational authority, responsibilities, accountability, and implementation plan of an
organization for ensuring quality in its work processes, products (items), and services. The quality system
provides the framework for planning, implementing, and assessing work performed by the organization
and for carrying out required QA and QC activities. (TNI)
Raw Data: The documentation generated during sampling and analysis. This documentation includes, but
is not limited to, field notes, electronic data, magnetic tapes, untabulated sample results, QC sample
results, print outs of chromatograms, instrument outputs, and handwritten records. (TNI)
Record Retention: The systematic collection, indexing and storing of documented information under
secure conditions.
Reference Material: Material or substance one or more properties of which are sufficiently
homogeneous and well established to be used for the calibration of an apparatus, the assessment of a
measurement method, or for assigning values to materials. (TNI)
Reference Standard: Standard used for the calibration of working measurement standards in a given
organization or a given location. (TNI)
Sampling: Activity related to obtaining a representative sample of the object of conformity assessment,
according to a procedure.
Second Order Polynomial Curve (Quadratic): The 2nd order curves are a mathematical calculation of a
slightly curved line over two axis. The y axis represents the instrument response (or Response ratio) of a
standard or sample and the x axis represents the concentration. The 2 nd order regression will generate a
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coefficient of determination (COD or r 2) that is a measure of the "goodness of fit" of the quadratic
curvature the data. A value of 1.00 indicates a perfect fit. In order to be used for quantitative purposes, r 2
must be greater than or equal to 0.99.
Selectivity: The ability to analyze, distinguish, and determine a specific analyte or parameter from
another component that may be a potential interferent or that may behave similarly to the target analyte or
parameter within the measurement system. (TNI)
Sensitivity: The capability of a method or instrument to discriminate between measurement responses
representing different levels (e.g., concentrations) of a variable of interest. (TNI)
Spike: A known mass of target analyte added to a blank, sample or sub-sample; used to determine
recovery efficiency or for other quality control purposes.
Standard: The document describing the elements of laboratory accreditation that has been developed
and established within the consensus principles of standard setting and meets the approval requirements
of standard adoption organizations procedures and policies. (TNI)
Standard Operating Procedures (SOPs): A written document which details the method for an operation,
analysis, or action, with thoroughly prescribed techniques and steps. SOPs are officially approved as the
methods for performing certain routine or repetitive tasks. (TNI)
Storage Blank: A blank matrix stored with field samples of a similar matrix (volatiles only) that measures
storage contribution to any source of contamination.
Systems Audit (also Technical Systems Audit): A thorough, systematic, qualitative on-site assessment
of the facilities, equipment, personnel, training, procedures, record keeping, data validation, data
management, and reporting aspects of a total measurement system. (EPA-QAD)
Technical Manager: A member of the staff of an environmental laboratory who exercises actual day-to-
day supervision of laboratory operations for the appropriate fields of accreditation and reporting of results
Technology: A specific arrangement of analytical instruments, detection systems, and/or preparation
techniques.
Traceability: The ability to trace the history, application, or location of an entity by means of recorded
identifications. In a calibration sense, traceability relates measuring equipment to national or international
standards, primary standards, basic physical constants or properties, or reference materials. In a data
collection sense, it relates calculations and data generated throughout the project back to the
requirements for the quality of the project. (TNI)
Trip Blank: A blank matrix placed in a sealed container at the laboratory that is shipped, held unopened
in the field, and returned to the laboratory in the shipping container with the field samples.
Uncertainty: A parameter associated with the result of a measurement that characterizes the dispersion
of the value that could reasonably be attributed to the measured value.
Acronyms:
AIHA-LAP, LLC – AIHA Laboratory Accreditation Programs, LLC
CAR – Corrective Action Report
CCV – Continuing Calibration Verification
CF – Calibration Factor
CFR – Code of Federal Regulations
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COC – Chain of Custody
DOC – Demonstration of Capability
DQO – Data Quality Objectives
DUP - Duplicate
EHS – Environment, Health and Safety
ELLAP (AIHA-LAP, LLC) - Environmental Lead Laboratory Accreditation Program
EMLAP (AIHA-LAP, LLC) – Environmental Microbiology Laboratory Accreditation Program
EPA – Environmental Protection Agency
GC - Gas Chromatography
GC/MS - Gas Chromatography/Mass Spectrometry
HPLC - High Performance Liquid Chromatography
ICP - Inductively Coupled Plasma Atomic Emission Spectroscopy
ICP/MS – ICP/Mass Spectrometry
ICV – Initial Calibration Verification
IDL – Instrument Detection Limit
IH – Industrial Hygiene
IHLAP (AIHA-LAP, LLC) – Industrial Hygiene Laboratory Accreditation Program
IS – Internal Standard
LCS – Laboratory Control Sample
LCSD – Laboratory Control Sample Duplicate
LIMS – Laboratory Information Management System
LOD – Limit of Detection
LOQ – Limit of Quantitation
MDL – Method Detection Limit
MDLCK – MDL Check Standard
MDLV – MDL Verification Check Standard
MRL – Method Reporting Limit Check Standard
MS – Matrix Spike
MSD – Matrix Spike Duplicate
NYS DOH – New York State Department of Health
SDS - Safety Data Sheet
NELAP - National Environmental Laboratory Accreditation Program
NIST NVLAP – National Institute of Standards and Technology National Voluntary Laboratory
Accreditation Program
TCEQ – Texas Commission of Environmental Quality
TNI – The NELAC Institute
QAM – Quality Assurance Manual
QA/QC – Quality Assurance / Quality Control
QAPP – Quality Assurance Project Plan
REP – Replicate
RF – Response Factor
RPD – Relative Percent Difference
RSD – Relative Standard Deviation
SD – Standard Deviation
SOP – Standard Operating Procedure
TAT – Turn-Around-Time
VOA – Volatiles
VOC – Volatile Organic Compound
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Facility Distribution No. ___________ Distributed To:_______________________

Quality Assurance Manual Cover Page

Eurofins Sacramento
880 Riverside Parkway
West Sacramento, CA 95605
Phone No. [phone]

https://www.eurofinsus.com/env

The information contained herein is of a highly confidential and proprietary nature. Eurofins
Environment Testing Northern California, LLC (parent of Eurofins Sacramento) specifically
prohibits the dissemination, copy, disclosure, transfer, or modification of this information without
the express written approval of Eurofins Environment Testing Northern California, LLC.

Uncontrolled Sacramento Bids Folder
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1.0 Title Page

Quality Assurance Manual
Approval Signatures

General Manager - Shea Hewage

Date
Business Unit Manager / Laboratory Director - Chris
Williams

Date
Quality Assurance Manager - Lisa Stafford

Date
Operations Manager /Technical Director - Robert Hrabak

Date
Client Service Manager - Jill Kellmann Date

for 01/27/2023
01/27/2023
01/26/2023
01/30/2023
01/26/2023
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2.0 TABLE OF CONTENTS
Contents
1.0 TITLE PAGE .......................................................................................................................................... 2
2.0 TABLE OF CONTENTS ........................................................................................................................ 4
3.0 INTRODUCTION, SCOPE AND APPLICABILITY ............................................................................ 10
3.1 INTRODUCTION AND COMPLIANCE REFERENCES ..................................................................................... 10
3.2 TERMS AND DEFINITIONS ....................................................................................................................... 10
3.3 SCOPE / FIELDS OF TESTING .................................................................................................................. 10
3.4 MANAGEMENT OF THE MANUAL .............................................................................................................. 11
3.4.1 Review Process ....................................................................................................................... 11
4.0 MANAGEMENT REQUIREMENTS ................................................................................................... 12
4.1 OVERVIEW ............................................................................................................................................. 12
4.2 ROLES AND RESPONSIBILITIES ............................................................................................................... 12
4.2.1 Vice President of Quality and Environmental Health and Safety (VP-QA/EHS) ....................... 12
4.2.2 Quality Directors ....................................................................................................................... 12
4.2.3 Quality Information Manager...................................................................................................... 13
4.2.4 Environmental Health and Safety (EH&S) Managers ............................................................... 13
4.2.5 NDSC Ethics and Compliance Officers (ECOs) ....................................................................... 13
4.2.6 Laboratory Director (Business Unit Manager) .......................................................................... 14
4.2.7 Quality Assurance (QA) Manager or Designee ........................................................................ 15
4.2.8 Technical Manager or Designee ............................................................................................... 16
4.2.9 Client Service Manager ............................................................................................................. 17
4.2.10 Project Manager (PM) & Project Manager Assistants (PMA) ................................................. 18
4.2.11 Department Managers or Designees ...................................................................................... 19
4.2.12 Laboratory Analysts ................................................................................................................ 20
4.2.13 Sample Custodians ................................................................................................................. 20
4.2.14 Quality Assurance Staff .......................................................................................................... 21
4.3 BUSINESS CONTINUITY AND CONTINGENCY PLANS ................................................................................... 22
5.0 PERSONNEL ..................................................................................................................................... 25
5.1 OVERVIEW .............................................................................................................................................. 25
5.2 EDUCATION AND EXPERIENCE REQUIREMENTS FOR TECHNICAL PERSONNEL ............................................. 25
5.3 TRAINING ............................................................................................................................................... 26
5.4 DATA INTEGRITY AND ETHICS TRAINING PROGRAM ................................................................................... 28
6.0 ACCOMMODATIONS AND ENVIRONMENTAL CONDITIONS ...................................................... 29
6.1 OVERVIEW .............................................................................................................................................. 29
6.2 ENVIRONMENT ........................................................................................................................................ 29
6.3 WORK AREAS........................................................................................................................................ 30
6.4 RESPONDING TO EMERGENCIES ............................................................................................................. 30
6.5 BUILDING SECURITY .............................................................................................................................. 30
7.0 QUALITY SYSTEM ........................................................................................................................... 32
7.1 QUALITY POLICY STATEMENT ................................................................................................................. 32
7.2 ETHICS AND DATA INTEGRITY .................................................................................................................. 33
7.3 QUALITY SYSTEM DOCUMENTATION ....................................................................................................... 34
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7.3.1 Order of Precedence ................................................................................................................. 34
7.4 QA/QC OBJECTIVES FOR THE MEASUREMENT OF DATA ......................................................................... 34
7.4.1 Precision .................................................................................................................................... 35
7.4.2 Accuracy ................................................................................................................................... 35
7.4.3 Representativeness .................................................................................................................. 35
7.4.4 Comparability ............................................................................................................................ 35
7.4.5 Completeness ........................................................................................................................... 36
7.4.6 Selectivity .................................................................................................................................. 36
7.4.7 Sensitivity .................................................................................................................................. 36
7.5 CRITERIA FOR QUALITY INDICATORS ....................................................................................................... 36
7.6 STATISTICAL QUALITY CONTROL ............................................................................................................ 36
7.6.1 QC Charts ................................................................................................................................. 37
7.7 QUALITY SYSTEM METRICS ..................................................................................................................... 37
8.0 DOCUMENT CONTROL .................................................................................................................... 38
8.1 OVERVIEW ............................................................................................................................................ 38
8.2 DOCUMENT APPROVAL AND ISSUE.......................................................................................................... 38
8.3 PROCEDURES FOR DOCUMENT CONTROL POLICY ................................................................................... 39
8.4 OBSOLETE DOCUMENTS ........................................................................................................................ 39
9.0 SERVICE TO THE CLIENT ................................................................................................................ 40
9.1 OVERVIEW ............................................................................................................................................ 40
9.2 REVIEW SEQUENCE AND KEY PERSONNEL .............................................................................................. 40
9.3 BALANCING LABORATORY CAPACITY AND W ORKLOAD .............................................................................. 41
9.4 DOCUMENTATION .................................................................................................................................. 42
9.4.1 Project-Specific Quality Planning .............................................................................................. 42
9.5 SPECIAL SERVICES ................................................................................................................................ 43
9.6 CLIENT COMMUNICATION ....................................................................................................................... 43
9.7 CLIENT CONFIDENTIALITY ...................................................................................................................... 43
9.8 REPORTING ........................................................................................................................................... 44
9.9 CLIENT FEEDBACK AND SURVEYS ........................................................................................................... 44
10.0 SUBCONTRACTING OF TESTS ....................................................................................................... 45
10.1 OVERVIEW ............................................................................................................................................ 45
10.2 QUALIFYING AND MONITORING SUBCONTRACTORS ................................................................................. 45
10.3 OVERSIGHT AND REPORTING ................................................................................................................. 46
10.4 CONTINGENCY PLANNING ...................................................................................................................... 47
10.5 USE OF NELAP AND ACCREDITING BODY LOGO ..................................................................................... 47
11.0 PURCHASING SERVICES AND SUPPLIES ..................................................................................... 48
11.1 OVERVIEW ............................................................................................................................................ 48
11.2 GLASSWARE ......................................................................................................................................... 48
11.3 REAGENTS, STANDARDS & SUPPLIES ..................................................................................................... 48
11.3.1 Purchasing ............................................................................................................................... 48
11.3.2 Receiving ................................................................................................................................. 49
11.3.3 Specifications........................................................................................................................... 49
11.3.4 Storage .................................................................................................................................... 50
11.4 PURCHASE OF EQUIPMENT / INSTRUMENTS / SOFTWARE......................................................................... 50
11.5 SERVICES ............................................................................................................................................. 51
11.6 SUPPLIERS ............................................................................................................................................ 51
11.6.1 New Vendor Procedure ........................................................................................................... 52
12.0 COMPLAINTS............................................................................................................................. 53
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12.1 OVERVIEW ............................................................................................................................................ 53
12.2 EXTERNAL COMPLAINTS ........................................................................................................................ 53
12.3 INTERNAL COMPLAINTS .......................................................................................................................... 54
12.4 MANAGEMENT REVIEW .......................................................................................................................... 54
13.0 CONTROL OF NON-CONFORMING WORK ................................................................................... 55
13.1 OVERVIEW ............................................................................................................................................ 55
13.2 RESPONSIBILITIES AND AUTHORITIES ..................................................................................................... 55
13.3 EVALUATION OF SIGNIFICANCE AND ACTIONS TAKEN .............................................................................. 56
13.4 PREVENTION OF NONCONFORMING W ORK ............................................................................................. 56
13.5 METHOD SUSPENSION / RESTRICTION (STOP WORK PROCEDURES) ........................................................ 56
14.0 CORRECTIVE ACTION ..................................................................................................................... 58
14.1 OVERVIEW ............................................................................................................................................ 58
14.2 GENERAL ............................................................................................................................................. 58
14.2.1 Non-Conformance Memo (NCM) ............................................................................................. 58
14.2.2 Corrective Actions Documented In the ICAT Database ......................................................... 58
14.3 CLOSED LOOP CORRECTIVE ACTION PROCESS ...................................................................................... 59
14.3.1 Cause Analysis ....................................................................................................................... 59
14.3.2 Selection and Implementation of Corrective Actions .............................................................. 59
14.3.3 Root Cause Analysis ............................................................................................................... 59
14.3.4 Monitoring of the Corrective Actions ....................................................................................... 60
14.3.5 Follow-up Audits ..................................................................................................................... 60
14.4 TECHNICAL CORRECTIVE ACTIONS ........................................................................................................ 60
14.5 BASIC CORRECTIONS ............................................................................................................................ 61
TABLE 14-1. EXAMPLE – GENERAL CORRECTIVE ACTION PROCEDURES .......................................................... 61
15.0 PREVENTIVE ACTION / IMPROVEMENT ................................................................................. 65
15.1 OVERVIEW ............................................................................................................................................ 65
15.2 MANAGEMENT OF CHANGE .................................................................................................................... 66
16.0 CONTROL OF RECORDS ......................................................................................................... 67
16.1 OVERVIEW ............................................................................................................................................ 67
TABLE 16-1. RECORD INDEX ......................................................................................................................... 67
16.2 PROGRAMS WITH LONGER RETENTION REQUIREMENTS .......................................................................... 69
TABLE 16-2. EXAMPLE: SPECIAL RECORD RETENTION REQUIREMENTS ..................................................... 69
16.3 TECHNICAL AND ANALYTICAL RECORDS ................................................................................................. 70
16.4 LABORATORY SUPPORT ACTIVITIES ....................................................................................................... 72
16.4.1 Sample Handling Records ...................................................................................................... 72
16.5 ADMINISTRATIVE RECORDS ................................................................................................................... 72
16.6 RECORDS MANAGEMENT, STORAGE AND DISPOSAL ............................................................................... 72
16.6.1 Transfer of Ownership ............................................................................................................. 73
16.6.2 Records Disposal .................................................................................................................... 73
17.0 AUDITS ....................................................................................................................................... 74
17.1 INTERNAL AUDITS ................................................................................................................................. 74
TABLE 17-1. TYPES OF INTERNAL AUDITS AND FREQUENCY ........................................................................... 74
17.1.1 Annual Quality Systems Audit ................................................................................................. 74
17.1.2 QA Technical Audits ............................................................................................................... 75
17.1.3 SOP Method Compliance ....................................................................................................... 75
17.1.4 Special Audits ......................................................................................................................... 75
17.1.5 Performance Testing ............................................................................................................... 75
17.2 EXTERNAL AUDITS ................................................................................................................................ 76
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17.2.1 Confidential Business Information (CBI) Considerations ........................................................ 76
17.3 AUDIT FINDINGS ................................................................................................................................... 76
18.0 MANAGEMENT REVIEWS ............................................................................................................... 77
18.1 QUALITY ASSURANCE REPORT .............................................................................................................. 77
18.2 ANNUAL MANAGEMENT REVIEW ............................................................................................................. 77
18.3 POTENTIAL INTEGRITY RELATED MANAGERIAL REVIEWS ......................................................................... 78
19.0 TEST METHODS AND METHOD VALIDATION ....................................................................... 79
19.1 OVERVIEW ............................................................................................................................................ 79
19.2 STANDARD OPERATING PROCEDURES (SOPS) ...................................................................................... 79
19.3 LABORATORY METHODS MANUAL .......................................................................................................... 79
19.4 SELECTION OF METHODS ...................................................................................................................... 79
19.4.1 Sources of Methods ................................................................................................................ 80
19.4.1.1 Client Supplied Methods ...................................................................................................... 80
19.4.2 DEMONSTRATION OF CAPABILITY ........................................................................................................ 81
19.4.3 Initial Demonstration of Capability (IDOC) Procedures .......................................................... 82
19.5 LABORATORY DEVELOPED METHODS AND NON-STANDARD METHODS .................................................... 82
19.6 VALIDATION OF METHODS ..................................................................................................................... 83
19.6.1 Method Validation and Verification Activities for All New Methods ......................................... 83
19.7 METHOD DETECTION LIMIT (MDL) / LIMITS OF DETECTION (LOD) ........................................................... 84
19.8 VERIFICATION OF DETECTION LIMITS...................................................................................................... 84
19.9 INSTRUMENT DETECTION LIMITS (IDL) ................................................................................................... 84
19.10 LIMIT OF QUANTITATION ...................................................................................................................... 84
19.11 RETENTION TIME W INDOWS ................................................................................................................ 85
19.12 EVALUATION OF SELECTIVITY .............................................................................................................. 85
19.13 ESTIMATION OF UNCERTAINTY OF MEASUREMENT ........................................................................... 85
19.14 SAMPLE REANALYSIS GUIDELINES ....................................................................................................... 86
19.15 CONTROL OF DATA ............................................................................................................................. 87
19.15.1 Computer and Electronic Data Related Requirements ......................................................... 87
19.15.2 Data Reduction ..................................................................................................................... 87
19.15.3 Logbook / Worksheet Use Guidelines .................................................................................. 88
19.15.4 Review / Verification Procedures .......................................................................................... 88
19.15.5 Manual Integrations .............................................................................................................. 90
FIGURE 19-1. EXAMPLE – WORK FLOW ......................................................................................................... 91
20.0 EQUIPMENT AND CALIBRATIONS .................................................................................................. 92
20.1 OVERVIEW ............................................................................................................................................ 92
20.2 PREVENTIVE MAINTENANCE .................................................................................................................. 92
20.3 SUPPORT EQUIPMENT ........................................................................................................................... 93
20.3.1 Weights and Balances ............................................................................................................ 93
20.3.2 pH, Conductivity, and Turbidity Meters ................................................................................... 94
20.3.3 Thermometers ......................................................................................................................... 94
20.3.4 Refrigerators/Freezer Units, Water baths, Ovens and Incubators .......................................... 94
20.3.5 Autopipettors, Dilutors, and Syringes .................................................................................... 95
20.4 INSTRUMENT CALIBRATIONS .................................................................................................................. 95
20.4.1 Calibration Standards ............................................................................................................. 95
20.5 TENTATIVELY IDENTIFIED COMPOUNDS (TICS) – GC/MS ANALYSIS ........................................................ 98
20.6 GC/MS TUNING.................................................................................................................................... 98
TABLE 20-1. INSTRUMENTATION LIST ............................................................................................................. 99
21.0 MEASUREMENT TRACEABILITY ................................................................................................. 100
21.1 OVERVIEW .......................................................................................................................................... 100
21.2 NIST-TRACEABLE W EIGHTS AND THERMOMETERS ............................................................................... 100
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21.3 REFERENCE STANDARDS / MATERIALS ................................................................................................. 100
21.4 DOCUMENTATION AND LABELING OF STANDARDS, REAGENTS, AND REFERENCE MATERIALS .................. 101
22.0 SAMPLING ...................................................................................................................................... 104
22.1 OVERVIEW .......................................................................................................................................... 104
22.2 SAMPLING CONTAINERS ...................................................................................................................... 104
22.2.1 Preservatives ........................................................................................................................ 104
22.3 DEFINITION OF HOLDING TIME ............................................................................................................. 104
22.4 SAMPLING CONTAINERS, PRESERVATION REQUIREMENTS, HOLDING TIMES ........................................... 104
22.5 SAMPLE ALIQUOTS / SUBSAMPLING...................................................................................................... 105
23.0 HANDLING OF SAMPLES ............................................................................................................... 106
23.1 CHAIN OF CUSTODY (COC) ................................................................................................................ 106
23.1.1 Field Documentation ............................................................................................................. 106
23.1.2 Legal / Evidentiary Chain-of-Custody ................................................................................... 107
23.2 SAMPLE RECEIPT ................................................................................................................................ 107
23.2.1 Laboratory Receipt ................................................................................................................ 107
23.3 SAMPLE ACCEPTANCE POLICY ............................................................................................................ 108
23.4 SAMPLE STORAGE .............................................................................................................................. 109
23.5 HAZARDOUS SAMPLES AND FOREIGN SOILS ......................................................................................... 109
23.6 SAMPLE SHIPPING .............................................................................................................................. 109
23.7 SAMPLE DISPOSAL .............................................................................................................................. 110
FIGURE 23-1. EXAMPLE: SAMPLE ACCEPTANCE POLICY ........................................................................ 110
24.0 ASSURING THE QUALITY OF TEST RESULTS ............................................................................ 113
24.1 OVERVIEW .......................................................................................................................................... 113
24.2 CONTROLS ......................................................................................................................................... 113
24.3 NEGATIVE CONTROLS ......................................................................................................................... 113
TABLE 24-1. EXAMPLE – NEGATIVE CONTROLS ............................................................................................ 113
24.4 POSITIVE CONTROLS .......................................................................................................................... 114
24.4.1 Method Performance Control - Laboratory Control Sample (LCS) ....................................... 114
24.5 SAMPLE MATRIX CONTROLS ................................................................................................................ 115
TABLE 24-5. SAMPLE MATRIX CONTROL ..................................................................................................... 115
24.6 ACCEPTANCE CRITERIA (CONTROL LIMITS) .......................................................................................... 116
24.7 ADDITIONAL PROCEDURES TO ASSURE QUALITY CONTROL ................................................................... 118
25.0 REPORTING RESULTS .................................................................................................................. 119
25.1 OVERVIEW .......................................................................................................................................... 119
25.2 TEST REPORTS ................................................................................................................................... 119
25.3 REPORTING LEVEL OR REPORT TYPE .................................................................................................. 121
25.4 ELECTRONIC DATA DELIVERABLES (EDDS) .......................................................................................... 121
25.5 SUPPLEMENTAL INFORMATION FOR TEST ............................................................................................. 122
25.6 ENVIRONMENTAL TESTING OBTAINED FROM SUBCONTRACTORS ........................................................... 123
25.7 CLIENT CONFIDENTIALITY .................................................................................................................... 123
25.8 FORMAT OF REPORTS ......................................................................................................................... 123
25.9 AMENDMENTS TO TEST REPORTS ........................................................................................................ 124
25.10 POLICIES ON CLIENT REQUESTS FOR AMENDMENTS ........................................................................... 124
25.10.1 Policy on Data Omissions or Reporting Limit Increases ..................................................... 124
25.10.2 Multiple Reports .................................................................................................................. 124
APPENDIX 1. LIST OF GOVERNING DOCUMENTS APPLICABLE TO THE QA MANUAL .......................................... 125
APPENDIX 2. LIST OF LABORATORY CERTIFICATIONS, ACCREDITATIONS, VALIDATIONS ................................... 127
APPENDIX 3. REFERENCES USED TO PREPARE THE QA MANUAL ................................................................... 128
APPENDIX 4. QA MANUAL CROSSWALK WITH TNI AND ISO/IEC 17025 STANDARDS ..................................... 129
APPENDIX 5. TERMS/GLOSSARY AND ACRONYMS (EL-V1M2 SEC. 3.1) ........................................................ 138
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APPENDIX 6. ANALYTICAL METHOD REFERENCES......................................................................................... 146
APPENDIX 7. LISTING OF METHODS PERFORMED .......................................................................................... 147
APPENDIX 8. LISTING OF COMMON DATA QUALIFIERS ................................................................................... 151
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3.0 INTRODUCTION, SCOPE AND APPLICABILITY
3.1 Introduction and Compliance References
Eurofins Sacramento’s Quality Assurance (QA) Manual is a document prepared to define the
overall policies, organization objectives and functional responsibilities for achieving the
laboratory’s QA Program. Governing SOPs are in place within the organization to ensure the
proper execution of this QA Manual (refer to Appendix 1). This manual and referenced documents
are required reading for all personnel.
The laboratory is a team of people who work together to serve the health and environmental
needs of society through science and technology. We offer comprehensive expertise in
environmental laboratory applications and client relations and maintain a national perspective in
terms of quality.
As such, this QA Manual has been prepared to assure compliance with The NELAC Institute (TNI)
Standard, dated 2009 and 2016; ISO/IEC Guide 17025:2005 and 2017 and the Department of
Defense (DoD)/Department of Energy (DOE) Quality Systems Manual (QSM). Policies and
procedures listed in Appendix 1 are compliant with the various accreditation and certification
programs which are held by the laboratory to support environmental work (Appendix 2).
Refer to Appendix 3 for a list of additional references for which this QA Manual is compliant; and
Appendix 4 for the compliance crosswalk of this manual to the TNI & ISO/IEC Guide 17025
requirements.
3.2 Terms and Definitions
A QA Program is a system designed to ensure that data produced by the laboratory conforms to
the standards set by state and/or federal regulations. The program functions at the local
management level through company goals, from guidance at the executive management level,
and at the analytical level through Standard Operating Procedures (SOPs) and quality control.
Our program is designed to minimize systematic error, encourage constructive, documented
problem solving, and provide a framework for continuous improvement within the organization to
better serve our clients.
Refer to Appendix 5 for a list of Terms and Acronyms.
3.3 Scope / Fields of Testing
The laboratory analyzes a broad range of environmental and industrial samples. Sample matrices
vary among air, drinking water, effluent water, groundwater, hazardous waste, sludge, tissue and
soils. The QA Program contains specific procedures and methods to test samples of differing
matrices for chemical, physical and biological parameters. The Program also contains guidelines
on maintaining documentation of analytical processes, reviewing results, servicing clients and
tracking samples through the laboratory. The technical and service requirements of all analytical
requests are thoroughly evaluated before commitments are made to accept the work.
Measurements are made using published reference methods or methods developed and
validated by the laboratory.
The methods covered by this manual include the most frequently requested methodologies
needed to provide analytical services in the United States and its territories. The specific list of
test methods used by the laboratory can be found in Appendix 7. Our areas of expertise include:
Standard Services Specialty Services
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 Volatiles
 Semivolatiles
 Metals
 Pesticides/PCBs
 Petroleum Hydrocarbons
 Waste Characterization
 Non-Potable Water Testing
 Drinking Water Testing
 Soil and Surface Water Testing
 Sediment and Tissue Testing
 Method Development
 Dioxins & Furans
 Perchlorate
 1,4-Dioxane
 PCB Congeners
 PFAS
 Pesticides by HRMS
NOTE: All current certificates and scopes of accreditation are available from the laboratory on
request.
The approach of this manual is to define the minimum level of quality assurance and quality
control necessary to meet these requirements. All methods performed by the laboratory shall
meet these criteria as appropriate. In some instances, quality assurance project plans (QAPPs),
project specific data quality objectives (DQOs) or local regulations may require criteria other than
those contained in this manual. In these cases, the laboratory will abide by the requested criteria
following review and acceptance of the requirements by the Laboratory President, General
Manager, Laboratory Director and/or Business Unit Manager and the Quality Assurance (QA)
Manager. In some cases, QAPPs and DQOs may specify less stringent requirements. The
Laboratory President, General Manager, Laboratory Director and/or Business Unit Manager and
the QA Manager must determine if it is in the lab’s best interest to follow the less stringent
requirements. Eurofins Sacramento shall not enter into any client agreement that conflicts with
regulatory requirements in the jurisdiction in which the work is being performed.
3.4 Management of the Manual
3.4.1 Review Process
This manual is reviewed annually by senior laboratory management to assure that it reflects
current practices and meets the requirements of the laboratory’s clients and regulators as well as
the QMP. Occasionally, the manual may need changes in order to meet new or changing
regulations and operations. The QA Manager will review the changes in the normal course of
business and incorporate changes into revised sections of the document. All updates will be
reviewed by the senior laboratory management staff. The laboratory updates and approves such
changes according to our Document Control & Updating procedures (refer to SOP/Document No.
WS-QA-0021).
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4.0 MANAGEMENT REQUIREMENTS
4.1 Overview
The laboratory is a local operating unit of Eurofins Environment Testing. The laboratory’s
operational and support staff have the day-to-day independent operational authority under the
direction of the Laboratory President, General Manager, and/or Business Unit
Manager/Laboratory Director and is supported by the NDSC QA team. The laboratory
management staff includes directors, managers and group leaders. The organizational chart of
the management staff is presented in Figure 4-1. Individual departmental staff lists are maintained
in the laboratory’s internal intranet.
4.2 Roles and Responsibilities
In order for the QA Program to function properly, all members of the staff must clearly understand
and meet their individual responsibilities as they relate to the quality program. The responsibility
for quality resides with every employee of the laboratory. All employees have access to the QA
Manual, are trained to this manual, and are responsible for upholding the standards therein. Each
person carries out his/her daily tasks impartially and in a manner consistent with the goals and in
accordance with the procedures in this manual and the laboratory’s SOPs. The following
descriptions briefly define each role in its relationship to the Quality Assurance Program.
4.2.1 Vice President of Quality and Environmental Health and Safety (VP -QA/EHS)
The Vice President (VP) of QA/EHS reports directly to Eurofins Environment Testing Chief
Operating Officer (COO). With the aid of the NDSC Quality Team Members, Business Unit
Managers, Laboratory Directors, the VP-QA/EHS has the responsibility for the establishment,
general overview and maintenance of the Quality Assurance and EH&S Programs within Eurofins
Environment Testing. Additional responsibilities include:
 Review of QA/QC and EHS aspects of NDSC Official Documents, national projects and
expansions or changes in services.
 Work with various organizations outside of the laboratory to further the development of quality
standards and represent the laboratory at various trade meetings.
 Prepare monthly reports for quality and EH&S metrics across the environmental testing
laboratories and a summary of any quality and EH&S related initiatives and issues.
 With the assistance of the Executive Management, EET Senior Management Teams, and the
EHS Managers, maintenance and implementation of the Eurofins Environment Testing
Environmental, Health and Safety Program.
4.2.2 Quality Directors
There are four (3) Quality Directors within NDSC that report directly to the VP-QA/EHS. These
Quality Directors have oversight of the general overview and maintenance of the QA Program
within the Eurofins Environment Testing laboratories. Supported tasks include:
- Monitors laboratory internal audit findings;
- Identifies common laboratory weaknesses and monitors corrective action closures.
- Develops NDSC quality guidance documents and management tools for ensuring and
improving compliance;
- Monitors and communicates DoD/DoE requirements;
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- Monitors and communicates regulatory and certification requirements;
- Training and On-Boarding
- Laboratory assessments, mentoring, and interventions
- Track/drive root cause investigations and corrective action plans
- Builds knowledge base for preventive actions
4.2.3 Quality Information Manager
The Quality Information works directly with the NDSC Quality Directors and EHS Managers; and
reports directly to the VP-QA/EHS. The Quality Information Manager is responsible for the
management of:
- NDSC Official Documents
- LIMS Certification Module Data
- Company’s Intranet website
- Company’s Regulatory Limits Database
- Subcontract laboratory and approved vendor information
- Internal and External client support for various company groups (e.g., Client Services, EH&S,
Legal, IT, Sales) for both quality and operational functions
- Communicate regulatory information and lists
4.2.4 Environmental Health and Safety (EH&S) Managers
There are 4 EH&S Managers within NDSC that report directly to the VP-QA/EHS. These EH&S
Managers have oversight of the general overview and maintenance of the EH&S Program within
the Eurofins Environment Testing laboratories. Supported tasks include:
 Consolidation and tracking all safety and health-related information and reports for the
company, and managing compliance activities for Eurofins Environment Testing locations.
 Coordination/preparation of the corporate Environmental, Health and Safety Manual Template
that is used by each laboratory to prepare its own laboratory-specific Safety Manual/ CHP.
 Preparation of information and training materials for laboratory EHS Coordinators.
 Assistance in the coordination of employee exposure and medical monitoring programs to
insure compliance with applicable safety and health regulations.
 Serving as Department of Transportation (D.O.T.) focal point and providing technical
assistance to location management.
 Serving as Hazardous Waste Management main contact and providing technical assistance
to location management.
4.2.5 NDSC Ethics and Compliance Officers (ECOs)
The NDSC VP-QA/EHS and Corporate Counsel are designated Ethics and Compliance Officers
(ECO). Each ECO acts as a back-up to the other ECO and both are involved when data
investigations occur. Each ECO has a direct line of communication to the entire executive
management personnel and lab management staff.
The ECOs monitor and audit procedures to determine compliance with policies and to make
recommendations for policy enhancements to the President, COO, Laboratory Director or other
appropriate individuals within the laboratory. The ECO will assist the laboratory QA Manager in
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the coordination of internal auditing of ethical policy related activities and processes within the
laboratory, in conjunction with the laboratory’s regular internal auditing function.
The ECOs will also participate in investigations of alleged violations of policies and work with the
appropriate internal departments to investigate misconduct, remedy the situation, and prevent
recurrence of any such activity.
4.2.6 Laboratory Director (Business Unit Manager)
The Laboratory Director is responsible for the overall quality, safety, financial, technical, human
resource and service performance of the whole laboratory and reports to their business unit
President. The Laboratory Director is also responsible for any service centers connected with
their laboratory that perform analytical tests, such as short holding time analyses for pH. The
Laboratory Director provides the resources necessary to implement and maintain an effective and
comprehensive Quality Assurance and Data Integrity Program.
Specific responsibilities include, but are not limited to:
 Provides one or more technical managers for the appropriate fields of testing. If the Technical
Manager is absent for a period of time exceeding 15 consecutive calendar days, the
Laboratory Director must designate another full time staff member meeting the qualif ications
of the Technical Manager to temporarily perform this function. If the absence exceeds 35
consecutive calendar days, the primary accrediting authority must be notified in writing.
 Ensures that all analysts and supervisors have the appropriate education and training to
properly carry out the duties assigned to them and ensures that this training has been
documented. Works with Eurofins Environment Testing Human Resources for hiring of new
personnel.
 Ensures that personnel are free from any commercial, financial and other undue pressures
which might adversely affect the quality of their work.
 Ensures company human resource policies are adhered to and maintained.
 Ensures that sufficient numbers of qualified personnel are employed to supervise and perform
the work of the laboratory. Assesses laboratory capacity and workload.
 Ensures that appropriate corrective actions are taken to address analyses identified as
requiring such actions by internal and external performance or procedural audits. Procedures
that do not meet the standards set forth in the QA Manual or laboratory SOPs may be
temporarily suspended by the Laboratory Director.
 Reviews and approves all SOPs prior to their implementation and ensures all approved SOPs
are implemented and adhered to.
 Pursues and maintains appropriate laboratory certification and contract approvals.
 Supports ISO 17025 requirements.
 Supporting DoD/DOE ELAP requirements
 Supporting the NELAC Institute (TNI) Standard requirements
 Ensures client specific reporting and quality control requirements are met.
 Contributes to the continuous improvement of the laboratory operations.
 Maintains an awareness of technical developments and regulatory requirements.
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 Captains the management team, consisting of the QA Manager, the Technical Managers, and
the EH&S Coordinator as direct reports.
4.2.7 Quality Assurance (QA) Manager or Designee
The QA Manager has responsibility and authority to ensure the continuous implementation of the
quality system at the laboratory where they work. The QA Manager is also responsible for any
service centers connected with their laboratory that perform analytical tests, such as short holding
time analyses for pH.
The QA Manager reports directly to the Laboratory Director and their NDSC Quality Director. This
position is able to evaluate data objectively and perform assessments without outside (e.g.,
managerial) influence. The NDSC QA Team may be used as a resource in dealing with regulatory
requirements, certifications and other quality assurance related items. The QA Manager directs
the activities of the QA office to accomplish specific responsibilities, which include, but are not
limited to:
 Serving as the focal point for QA/QC in the laboratory.
 Serve as the Eurofins Sacramento Ethics Compliance Officer in accordance with NDSC
document SOP-01-QA-QP5252.
 Having functions independent from laboratory operations for which the QA Manager has
quality assurance oversight.
 Have documented training and/or experience in QA/QC procedures and the laboratory’s
Quality System.
 Maintaining and updating the QA Manual.
 Monitoring and evaluating laboratory certifications; scheduling proficiency testing samples.
 Monitoring and communicating regulatory changes that may affect the laboratory to
management.
 Training and advising the laboratory staff on quality assurance/quality control procedures that
are pertinent to their daily activities.
 Having a general knowledge of the analytical test methods for which data audit/review is
performed (and/or having the means of getting this information when needed).
 Arranging for or conducting internal audits on quality systems and the technical operation.
 Performing technical data audits and method audits to ensure consistency and compliance
with regulatory requirements.
 Maintaining records of all ethics-related training, including the type and proof of attendance.
 Maintaining, improving, and evaluating the corrective action database and the corrective and
preventive action systems.
 Notifying laboratory management of deficiencies in the quality system and ensuring
corrective action is taken. Procedures that do not meet the standards set forth in the QA
Manual or laboratory SOPs shall be investigated following procedures outlined in Section 14
and if deemed necessary may be temporarily suspended during the investigation.
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 Objectively monitoring standards of performance in quality control and quality assurance
without outside (e.g., managerial) influence.
 Coordinating document control of SOPs, MDLs, control limits, and miscellaneous forms and
information.
 Reviewing external audit reports and data validation requests.
 Following-up with audits to ensure client QAPP requirements are met.
 Establishing reporting schedule and preparation of various quality reports for the Laboratory
Director, clients and/or the NDSC QA Team.
 Developing suggestions and recommendations to improve quality systems.
 Researching current state and federal requirements and guidelines.
 Directing the QA team to enable communication and to distribute duties and responsibilities.
 Ensuring communication with laboratory staff and monitoring standards of performance to
ensure that systems are in place to produce the level of quality as defined in this document.
 Participate in the vendor and supplier approval process, including subcontractors.
 Communication to the relevant regulatory authorities when there are management or facility
changes that impact the laboratory.
 Evaluating of the thoroughness and effectiveness of training.
 Assuring compliance with ISO 17025.
 Assuring compliance with DoD/DOE QSM.
 Assuring compliance with The NELAC Institute (TNI) Standard.
4.2.8 Technical Manager or Designee
The Technical Manager and designee(s) report directly to the Laboratory Director. The Technical
Manager is accountable for all analyses and analysts under their experienced supervision and for
compliance with the ISO 17025:2017 Standard. The scope of responsibility ranges from the new-
hire process and existing technology through the ongoing training and development programs for
existing analysts and new instrumentation. Specific responsibilities include, but are not limited to:
 Exercising day-to-day supervision of laboratory operations for the appropriate field of
accreditation and reporting of results. Coordinating, writing, and reviewing preparation of all
test methods, i.e., SOPs, with regard to quality, integrity, regulatory and optimum and efficient
production techniques, and subsequent analyst training and interpretation of the SOPs for
implementation and unusual project samples. The Technical Manager insures that the SOPs
are properly managed and adhered to at the bench. The Technical Manager develops
standard costing of SOPs to include supplies, labor, overhead, and capacity (design versus
demonstrated versus first run yield) utilization.
 Reviewing and approving, with input from the QA Manager, proposals from marketing, in
accordance with an established procedure for the review of requests and contracts. This
procedure addresses the adequate definition of methods to be used for analysis and any
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limitations, the laboratory’s capability and resources, the client’s expectations. Differences
are resolved before the contract is signed and work begins. A system documenting any
significant changes is maintained, as well as pertinent discussions with the client regarding
their requirements or the results of the analyses during the performance of the contract. All
work subcontracted by the laboratory must be approved by the client. Any deviations from
the contract must be disclosed to the client. Once the work has begun, any amendments to
the contract must be discussed with the client and so documented.
 Monitoring the validity of the analyses performed and data generated in the laboratory. This
activity begins with reviewing and supporting all new business contracts, insuring data
quality, analyzing internal and external non-conformances to identify root cause issues and
implementing the resulting corrective and preventive actions, facilitating the data review
process (training, development, and accountability at the bench), and providing technical
and troubleshooting expertise on routine and unusual or complex problems.
 Providing training and development programs to applicable laboratory staff as new hires and,
subsequently, on a scheduled basis. Training includes instruction on calculations,
instrumentation management to include troubleshooting and preventive maintenance.
 Enhancing efficiency and improving quality through technical advances and improved LIMS
utilization. Capital forecasting and instrument life cycle planning for second generation
methods and instruments as well as asset inventory management.
 Coordinating sample management from “cradle to grave,” insuring that no time is lost in
locating samples.
 Scheduling all QA/QC-related requirements for compliance, e.g., MDLs, etc.
 Directing department personnel to communicate quality, technical, personnel, and
instrumental issues for a consistent team approach.
 Complying with ISO 17025, The NELAC Institute (TNI) Standard, DoD/DOE QSM and the
various QC programs implemented at the laboratory.
4.2.9 Client Service Manager
The Client Service Manager reports to the Laboratory Director and serves as the interface
between the laboratory’s technical departments and the laboratory’s clients. The staff consists of
the Project Management team. With the overall goal of total client satisfaction, the duties of this
position are outlined below:
 Managing technical training and growth of the Project Management team
 Serving as technical liaison for the Project Management team
 Providing human resource management of the Project Management team
 Ensuring that clients receive the proper sampling supplies
 Overseeing response to client inquiries concerning sample status
 Assisting clients regarding the resolution of problems concerning COC
 Ensuring that client specifications, when known, are met by communicating project and
quality assurance requirements to the laboratory
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 Notifying the department managers of incoming projects and sample delivery schedules
 Being accountable to clients for communicating sample progress in daily status meeting with
agreed-upon due dates
 Discussing with clients any project-related problems, resolving service issues, and
coordinating technical details with the laboratory staff
 Providing information to staff with respect to specific quotes, sample log -in review, and final
report completeness
 Monitoring the status of all data package projects in-house to ensure timely and accurate
delivery of reports
 Informing clients of data package-related problems and resolve service issues
 Coordinating requests for sample containers and other services (data packages)
4.2.10 Project Manager (PM) & Project Manager Assistants (PMA)
Members of the laboratory Project Management Group are responsible for organizing and
managing client projects. Clients are assigned a project manager who serves as their primary
contact at the laboratory. It is the PM’s responsibility to act as the client advocate by
communicating client requirements to laboratory personnel and ensuring that clients provide
complete information needed by the laboratory to meet those requirements – including all verbal
communications.
The Project Manager’s responsibilities include:
 Scheduling sample submissions, sample container orders and sample pick-up via the
laboratory courier service.
 Confirming certification status
 Coordinating and communicating turnaround time (TAT) requirements for high priority
samples/projects.
 Answering common technical questions, facilitating problem resolution and coordinating
technical details with the laboratory staff.
 Ensuring client specifications, when known, are met by communicating project and quality
assurance requirements to the laboratory
 Notifying laboratory personnel of incoming projects and sample delivery schedules
 Coordinating and communicating with EH&S staff regarding new/unusual sample matrices
and/or analyses in advance of arrival of the work.
 Monitoring the status of all projects in-house to ensure timely delivery of reports
 Coordinating client requests for sample containers and other services
 Scheduling sample pick-ups from client offices or project sites and notifying the laboratory
staff of incoming samples
 Coordinating subcontract work
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 Assisting clients in procuring the proper sampling supplies
 Responding to client inquiries concerning sample status
4.2.11 Department Managers or Designees
Department Managers report directly to the Laboratory Director. They supervise the daily activities
of analysis within a given laboratory area, and either oversee the review and approval, or perform
the review and approval of all analytical data within that area.
Specific responsibilities include, but are not limited to:
 Ensure that analysts in their department adhere to applicable SOPs and the QA Manual.
They perform frequent SOP and QA Manual review to determine if analysts are in compliance
and if new, modified, and optimized measures are feasible and should be added to these
documents.
 With regard to analysts, participates in the selection, training (as documented in Section 5.3),
development of performance objectives and standards of performance, appraisal
(measurement of objectives), scheduling, counseling, discipline, and motivation of analysts
and documents these activities in accordance with systems developed by the QA and
Personnel Departments. They evaluate staffing sufficiency and overtime needs. Training
consists of familiarization with SOP, QC, Safety, and computer systems.
 Encourage the development of analysts to become cross-trained in various methods and/or
operate multiple instruments efficiently while performing maintenance and documentation,
self-supervise, and function as a department team.
 Provide guidance to analysts in resolving problems encountered daily during sample
prep/analysis in conjunction with the Technical Manager, Operations Manager, and/or QA
Manager. Each is responsible for 100% of the data review and documentation, non-
conformance and CPAR issues, the timely and accurate completion of performance
evaluation samples and MDLs, for his department.
 Ensure all logbooks are maintained, current, and properly labeled or archived.
 Report all non-conformance conditions to the QA Manager, Technical Manager, Operations
Manager, and/or BU / Laboratory Director.
 Ensure that preventive maintenance is performed on instrumentation as detailed in the QA
Manual or SOPs. He is responsible for developing and implementing a system for preventive
maintenance, troubleshooting, and repairing or arranging for repair of instruments.
 Maintain adequate and valid inventory of reagents, standards, spare parts, and other relevant
resources required to perform daily analysis.
 Achieve optimum turnaround time on analyses and compliance with holding times.
 Conduct efficiency and cost control evaluations on an ongoing basis to determine
optimization of labor, supplies, overtime, first-run yield, capacity (designed vs.
demonstrated), second- and third-generation production techniques/instruments, and long-
term needs for budgetary planning.
 Develop, implement, and enhance calibration programs.
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 Provide written responses to external and internal audit issues.
 Complying with ISO 17025:2017, The NELAC Institute (TNI) Standard, DoD/DOE QSM and
the various QC programs implemented at the laboratory.
4.2.12 Laboratory Analysts
Laboratory analysts are responsible for conducting analysis and performing all tasks assigned to
them by the group leader or supervisor. The responsibilities of the analysts are listed below:
 Performing analyses by adhering to analytical and quality control protocols prescribed by
current SOPs, this QA Manual, and project-specific plans honestly, accurately, timely, safely,
and in the most cost-effective manner.
 Document standard and sample preparation, instrument calibration and maintenance, data
calculations, sample matrix effects, and any observed non-conformance on worklists,
benchsheets, lab notebooks and/or the Non-Conformance Database.
 Report all non-conformance situations, sample preparation problems, instrument problems,
matrix problems and QC failures, which might affect the reliability of the data, to their
supervisor, the Technical Manager, and/or the QA Manager or member of QA staff.
 Perform 100% review of the data generated prior to entering and submitting for secondary
level review.
 Suggest method improvements to their supervisor, the Technical Manager, and the QA
Manager. These improvements, if approved, will be incorporated. Providing ideas for the
optimum performance of their assigned area, for example, through the proper cleaning and
maintenance of the assigned instruments and equipment, are encouraged.
 Working cohesively as a team member in their department to achieve the goals of accurate
results, optimum turnaround time, cost effectiveness, cleanliness, complete documentation,
and personal knowledge of environmental analysis.
4.2.13 Sample Custodians
The Sample Custodians ensure the implementation of proper sample receipt procedures,
including maintaining chain-of -custody. The Sample Custodian logs samples into the LIMS and
ensures that all samples are stored appropriately. Duties for the Sample Custodian include the
following:
 Receiving and unloading samples or consignments in accordance with DOT regulations
 Verifying samples against the Chain of Custody (COC)
 Logging samples into the LIMS to assign a lot number for tracking purposes, and notifying
Project Managers of any irregularities with the sample shipment.
 Labeling samples with lot number assigned and deliver the samples to the appropriate labs
for analysis daily
 Monitoring sample receiving area freezer and cooler temperatures daily to confirm that the
readings are within SOP guidelines
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 Shipping all subcontracted samples to designated lab in accordance with DOT regulations
as needed.
4.2.14 Quality Assurance Staff
The Quality Assurance staff members report to the QA manager. They have responsibility and
authority to ensure the continuous implementation of the quality system based on ISO 17025,
through involvement in the following activities:
 Assisting the QA Manager in performing the annual internal laboratory audits, compiling the
evaluation, and coordinating the development of an action plan to address any deficiency
identified.
 Facilitating external audits, coordinating with the QA Manager and Laboratory Staff to
address any deficiencies noted at the time of the audit and subsequently presented in the
final audit report.
 Assisting the QA Manager in the preparation of new SOPs and in the maintenance of existing
SOPs, coordinating annual reviews and updates.
 Managing the performance testing (PT) studies, coordinating follow-up studies for failed
analytes, and working with QA Manager and Laboratory Staff to complete needed corrective
action reports.
 Serving as a project manager for proficiency testing samples and other QC samples.
 Reviewing and maintaining personnel training records.
 Assisting the QA Manager and Project Management Group in the review of program plans
for consistency with organizational and contractual requirements. Summarize and convey to
appropriate personnel anomalies or inconsistencies observed in the review process.
 Managing certifications and accreditations.
 Monitoring for compliance with the following QA Metrics: Temperature Monitoring of
refrigeration units; thermometer verifications and calibrations; balance verifications and
calibrations; and Eppendorf/pipette calibrations.
 Periodically checking the proper use and review of logbooks.
 Assisting in the technical review of data packages which require QA review.
 Assisting the QA Manager in maintaining the laboratory’s reference data to keep it current
and accurate.
 Preparing certification applications for states as directed by QA Manager.
 Performing document control maintenance.
 Assisting departments in generating MDL spreadsheets and calculations, reviewing MDL
studies submitted to QA.
 Assisting in control limit generation.
 Ensuring maintenance of records archives.
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 Maintaining historical indices for all technical records including SOPs, QC records, laboratory
data, etc.
 Assisting the QA Manager in meeting the responsibilities of the QA Department as described
in laboratory policies and SOPs.
4.3 Business Continuity and Contingency Plans
Various policies and practices are in place to address continuity of business and contingency
plans to ensure continued operations or minimal disruption in operations should unplanned events
(natural disasters, unexpected management changes, etc.) occur. Deputies are identified for all
key management personnel. Deputies would temporarily fill a role if the primary is absent for more
than 15 consecutive calendar days. The deputies must meet the same qualifications as the
primary person should they be required to take on the responsibilities. The QA Manager
communicates to the relevant regulatory authorities when there are management or facility
changes that impact the laboratory. Changes in the technical director must be communicated
within a period of time and in the manner dictated by each regulatory authority.
The following table defines who assumes the responsibilities of key personnel in their absence:
Key Personnel Deputy
Chris Williams
Laboratory Director/Business Unit Manager
Robert Hrabak
Technical Director, Operations
Manager
Lisa Stafford
Quality Manager
Chris Williams
Laboratory Director/Business Unit
Manager
Robert Hrabak
Technical Director, Operations Manager
Chris Williams
Laboratory Director/Business Unit
Manager
Victoria Nihart
Manager of Semivolatiles
Chris Williams
Laboratory Director/Business Unit
Manager
Bijan Jafari
Manager of Volatiles & Organic Preparation
Chris Williams
Laboratory Director/Business Unit
Manager
Veronika Melnik
Manager of LCMS
Robert Hrabak
Technical Director, Operations
Manager
Joe Schairer
EHS Coordinator
Chris Williams
Laboratory Director/Business Unit
Manager
Jill Kellmann
Client Service Manager
Chris Williams
Laboratory Director/Business Unit
Manager

Figure 4-1. Laboratory Organization Charts

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5.0 PERSONNEL
5.1 Overview
The laboratory’s management believes that its highly qualified and professional staff is the single
most important aspect in assuring a high level of data quality and service. The staff consists of
professionals and support personnel.
All personnel must demonstrate competence in the areas where they have responsibility. Any
staff that is undergoing training shall have appropriate supervision until they have demonstrated
their ability to perform their job function on their own. Staff shall be qualified for their tasks based
on appropriate education, training, experience and/or demonstrated skills as required.
The laboratory employs sufficient personnel with the necessary education, training, technical
knowledge and experience for their assigned responsibilities.
All personnel are responsible for complying with all QA/QC requirements that pertain to the
laboratory and their area of responsibility. Each staff member must have a combination of
experience and education to adequately demonstrate a specific knowledge of their particular area
of responsibility. Technical staff must also have a general knowledge of lab operations, test
methods, QA/QC procedures and records management.
Laboratory management is responsible for formulating goals for lab staff with respect to
education, training and skills and ensuring that the laboratory has a policy and procedures for
identifying training needs and providing training of personnel. The training shall be relevant to
the present and anticipated responsibilities of the lab staff.
The laboratory only uses personnel that are employed by or under contract to, the laboratory.
Contracted personnel, when used, must meet competency standards of the laboratory and work
in accordance to the laboratory’s quality system.
5.2 Education and Experience Requirements for Technical Personnel
The laboratory makes every effort to hire analytical staff that possess a college degree (e.g. AA,
BA, BS) in an applied science with some chemistry in the curriculum. Exceptions can be made
based upon the individual’s experience and ability to learn. Selection of qualified candidates for
laboratory employment begins with documentation of minimum education, training, and experience
prerequisites needed to perform the prescribed task. Minimum education and training requirements
for laboratory employees are outlined in job descriptions maintained by Eurofins Environment
Testing Human Resources and are generally summarized for analytical staff in the table below.
Experience and specialized training are occasionally accepted in lieu of a college degree (basic
lab skills such as using a balance, colony counting, aseptic or quantitation techniques, etc., are
also considered).
As a general rule for analytical staff:
Specialty Education Experience
Extractions, Digestions, some electrode methods
(pH, DO, Redox, etc.), or Titrimetric and
Gravimetric Analyses
H.S. Diploma On the job training
(OJT)
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Specialty Education Experience
GFAA, CVAA, FLAA, Single component or short
list Chromatography (e.g., Fuels, BTEX-GC, IC
A college degree in
an applied science or
2 years of college
and at least 1 year of
college chemistry
Or 2 years prior
analytical experience
is required
ICP, ICPMS, Long List or complex
chromatography (e.g., Pesticides, PCB,
Herbicides, HPLC, etc.), GCMS
A college degree in
an applied science or
2 years of college
chemistry
or 5 years of prior
analytical experience
Spectra Interpretation A college degree in
an applied science or
2 years of college
chemistry
And 2 years relevant
experience
Or
5 years of prior
analytical experience
Technical Managers Bachelor’s Degree in
an applied science or
engineering1 with 24
semester hours in
chemistry

An advanced (MS,
PhD.) degree may
substitute for one
year of experience
And 3 years
experience in
environmental
analysis of
representative
analytes for which
they will oversee
Principal Analyst of Sophisticated Technology (e.g.
GCMS, ICP, ICPMS, LCMS, GC, GCMS)
Bachelor’s Degree in
an applied science or
engineering1

6 months experience
instrument operation
in the analysis of
environmental
samples.
1 Applied science or engineering disciplines include the following: chemistry, biochemistry, biology,
microbiology, natural or physical science, environmental engineering, sanitary engineering or chemical
engineering.
When an analyst does not meet these requirements, they can perform a task under the direct
supervision of a qualified analyst, peer reviewer or Technical Manager, and are considered an
analyst in training. The person supervising an analyst in training is accountable for the quality of the
analytical data and must review and approve data and associated corrective actions.
5.3 Training
The laboratory is committed to furthering the professional and technical development of
employees at all levels.
Orientation to the laboratory’s policies and procedures, in-house method training, and employee
attendance at outside training courses and conferences all contribute toward employee proficiency.
Below are examples of various areas of required employee training:

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Required Training Time Frame Employee Type
Environmental Health & Safety Prior to lab work All
Ethics – New Hires 1 week of hire All
Ethics – Comprehensive

60 days of hire All

Data Integrity

60 days of hire

Technical and PMs

Quality Assurance 90 days of hire All
Ethics – Comprehensive
Refresher
Annually All
Initial Demonstration of
Capability (DOC)
Prior to unsupervised
method performance
Technical

The laboratory maintains records of relevant authorization/competence, education, professional
qualifications, training, skills and experience of technical personnel (including contracted
personnel) as well as the date that approval/authorization was given. These records are kept on
file at the laboratory. Also refer to “Demonstration of Capability” in Section 19.
The training of technical staff is kept up to date by:
 Each employee must have documentation in their training file that they have read, understood
and agreed to follow the most recent version of the laboratory QA Manual and SOPs in their
area of responsibility. This documentation is updated as SOPs are updated.
 Documentation from any training courses or workshops on specific equipment, analytical
techniques or other relevant topics.
 Documentation of proficiency (refer to Section 19).
 An Ethics Agreement signed by each staff member (renewed each year) and evidence of
annual ethics training.
 A Confidentiality Agreement signed by each staff member signed at the time of employment.
 Human Resources maintains documentation and attestation forms on employment status and
records; confidentiality; benefit programs; timekeeping/payroll; and employee conduct (e.g.,
ethics violations). This information is maintained in the employee’s secured personnel file.
Evidence of successful training could include such items as:
 Adequate documentation of training within operational areas, including one-on-one technical
training for individual technologies, and particularly for people cross-trained.
 Analyst’s knowledge to refer to QA Manual for quality issues.
 Analysts following SOPs, i.e., practice matches SOPs.
 Analysts regularly communicate to supervisors and QA if SOPs need revision, rather than
waiting for auditors to find problems.
Further details of the laboratory's training program are described in the Laboratory Training SOP
(WS-QA-0022).
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5.4 Data Integrity and Ethics Training Program
The laboratory’s Ethics and Data Integrity Program is discussed in Section 6.2. Employees are
trained as to the legal and environmental repercussions that result from data misrepresentation.
Key topics covered in the presentation include:
 Organizational mission and its relationship to the critical need for honesty and full disclosure
in all analytical reporting.
 Ethics Policy
 How and when to report ethical/data integrity issues. Confidential reporting.
 Record keeping.
 Discussion regarding data integrity procedures.
 Specific examples of breaches of ethical behavior (e.g. peak shaving, altering data or
computer clocks, improper macros, etc., accepting/offering kickbacks, illegal accounting
practices, unfair competition/collusion)
 Internal monitoring. Investigations and data recalls.
 Consequences for infractions including potential for immediate termination, debarment, or
criminal prosecution.
 Importance of proper written narration / data qualification by the analyst and project manager
with respect to those cases where the data may still be usable but are in one sense or another
partially deficient.
Resources for reporting data integrity and ethics concerns are available on the EET-Net
sharepoint site and posted in various locations throughout the laboratory. Additionally, a data
integrity hotline [phone]) is available.
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6.0 ACCOMMODATIONS AND ENVIRONMENTAL CONDITIONS
6.1 Overview
The laboratory is a 66,000 ft2 secure laboratory facility with controlled access and designed to
accommodate an efficient workflow and to provide a safe and comfortable work environment for
employees. All visitors sign in and are escorted by laboratory personnel. Access is controlled by
various measures.
The laboratory is equipped with structural safety features. Each employee is familiar with the
location, use, and capabilities of general and specialized safety features associated with their
workplace. The laboratory provides and requires the use of protective equipment including safety
glasses, protective clothing, gloves, etc., OSHA and other regulatory agency guidelines regarding
required amounts of bench and fume hood space, lighting, ventilation (temperature and humidity
controlled), access, and safety equipment are met or exceeded.
Traffic flow through sample preparation and analysis areas is minimized to reduce the likelihood
of contamination. Adequate floor space and bench top area is provided to allow unencumbered
sample preparation and analysis space. Sufficient space is also provided for storage of reagents
and media, glassware, and portable equipment. Ample space is also provided for refrigerated
sample storage before analysis and archival storage of samples after analysis. Laboratory HVAC
and deionized water systems are designed to minimize potential trace contaminants.
The laboratory is separated into specific areas for sample receiving, sample preparation, volatile
organic sample analysis, non-volatile organic sample analysis, inorganic sample analysis and
administrative functions.
6.2 Environment
Laboratory accommodation, test areas, energy sources, and lighting are adequate to facilitate
proper performance of tests. The facility is equipped with heating, ventilation, and air conditioning
(HVAC) systems appropriate to the needs of environmental testing performed at this laboratory.
The environment in which these activities are undertaken does not invalidate the results or
adversely affect the required accuracy of any measurements.
The laboratory provides for the effective monitoring, control and recording of environmental
conditions that may affect the results of environmental tests as required by the relevant
specifications, methods, and procedures. Such environmental conditions include humidity,
voltage, temperature, and vibration levels in the laboratory In the event of a power outage, the
laboratory can be equipped with a backup power supply for sample storage, as detailed in SOP
No. WS-QA-0005, Temperature Monitoring and Corrective Action for Refrigerators and Freezers
and WS-WI-0880, Emergency Power Outage Procedure.
When any of the method or regulatory required environmental conditions changes to a point
where they may adversely affect test results, analytical testing will be discontinued until the
environmental conditions are returned to the required levels.
Environmental conditions of the facility housing the computer network and LIMS are regulated to
protect against raw data loss.
When the laboratory performs laboratory activities at sites or facilities outside its permanent
control, it shall ensure that the requirements related to facilities and environmental conditions of
this document are met.
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Specific requirements for facility and environmental conditions, as well as periodic monitoring of
conditions, are given in the Environmental Health & Safety Manual (NDSC-US EHS-QP46060)
plus the laboratory’s Facility Addendum (WS-PEHS-002)
6.3 Work Areas
There is effective separation between neighboring areas when the activities therein are
incompatible with each other. Examples include:
 Volatile organic chemical handling areas, including sample preparation and waste disposal,
and volatile organic chemical analysis areas.
Access to and use of all areas affecting the quality of analytical testing is defined and controlled
by secure access to the laboratory building as described below in the Building Security section.
Adequate measures are taken to ensure good housekeeping in the laboratory and to ensure that
any contamination does not adversely affect data quality. These measures include regular
cleaning to control dirt and dust within the laboratory. Work areas are available to ensure an
unencumbered work area. Work areas include:
 Access and entryways to the laboratory.
 Sample receipt areas.
 Sample storage areas.
 Chemical and waste storage areas.
 Data handling and storage areas.
 Sample processing areas.
 Sample analysis areas.
6.4 Responding to Emergencies
Employees must be aware of procedures to respond to all emergencies that might occur in the
workplace. Employees must be familiar with the location and proper operation of all emergency
equipment, evacuation routes and designated assembly areas for all areas where they work.
Refer to the HSE Manual Document No. NDSC-US EHS-QP46060 Sec. 7 and the laboratory’s
local EH&S addendum (WS-PEHS-002) for complete details. These documents provide direction
for situations where normal operations of the laboratory are not possible (e.g., electrical failures,
heating/air conditioning failures, fire/building evacuation, computer failures, hazardous material
spills, injury to employees, pandemic flu, disruption of phone service, etc. )
In the event that the building or information technology (IT) systems would be severely
challenged, a designated disaster recovery team, which includes Facility Management,
Maintenance, Safety, Laboratory/Executive Management, Public Relations, IT, QA and other
applicable personnel depending on the scope of the disaster, would assemble at a designated
area to assess the situation and formulate a plan.
6.5 Building Security
The laboratory is considered a secure facility. All outside doors (except the main lobby entrance)
are locked during normal business hours to prevent unauthorized entry. Access to the laboratory
from the lobby is controlled by key card access. Building keys, key cards, and alarm codes are
distributed to employees as necessary.
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Employees wear photographic identification badges or temporary badges without a photo while
on the premises.
Visitors to the laboratory sign in and out in a visitor’s logbook. A visitor is defined as any person
who visits the laboratory who is not an employee of the laboratory. Both visitors and vendors
must review and sign the EH&S specific forms. Visitors (with the exception of company
employees) are escorted by laboratory personnel at all times, or the location of the visitor is noted
in the visitor’s logbook.

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7.0 QUALITY SYSTEM
7.1 Quality Policy Statement
It is Eurofins Sacramento’s Policy to:
 Provide data of known and documented quality to its client by adhering to approved
methodologies, regulatory requirements and the QA/QC protocols.
 Effectively manage all aspects of the laboratory and business operations by the highest ethical
standards
 Continually improve systems and provide support to quality improvement efforts in the
laboratory, administrative, and managerial activities. Eurofins Sacramento recognizes that the
implementation of a quality assurance program requires management’s commitment and
support as well as the involvement of the entire staff.
 Provide clients with the highest level of professionalism and the best service practices in the
industry
 To comply with the ISO/IEC 17025:2017(E) / 17025:2005 (E) International Standards and the
2009/2016 TNI Standard, and to continually improve the effectiveness of the management
system.
As an organization, all personnel are committed to high quality professional practice, testing and
data, and service to our clients. We strive to provide the highest quality data achievable by:
 Reading and understanding all of the quality documents applicable to each position and
implementing the process in our work.
 Following all recordkeeping requirements; describing clearly and accurately all activities
performed; recording “real time” as the task is carried out; understanding that it is never
acceptable to “back date” entries and should additional information be required at a later date,
the actual date and by whom the notation is made must be documented.
 Ensuring data integrity through the completeness, consistency, impartiality and accuracy of
the data generated. Data is attributable, legible, contemporaneously recorded, original or a
true copy, and accurate (ALCOA). This applies to manual paper documentation and electronic
records.
 Providing accountability and traceability for each sample analyzed through proper sample
handling, labeling, preparation, instrument calibration/qualification/validation, analysis, and
reporting; establishing an audit trail (the who, what, when, and why) that identifies date, time,
analyst, instrument used, instrument conditions, quality control samples (where appropriate
and/or required by the method), and associated standard material.
 Emphasizing a total quality management process which provides impartiality, accuracy, and
strict compliance with agency regulations and client requirements, giving the highest degree
of confidence; understanding that meeting the requirements of the next employee in the work
flow process is just as important as meeting the needs of the external client.
 Providing thorough documentation and explanation to qualify reported data that may not meet
all requirements and specifications, but is still of use to the client; understanding this occurs
only after discussion with the client on the data limitations and acceptability of this approach.
 Responding immediately to indications of questionable data, out-of-specification occurrences,
equipment malfunctions, and other types of laboratory problems, with investigation and
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applicable corrective action; documenting these activities completely, including the reasons
for the decisions made.
 Providing a work environment that ensures accessibility to all levels of management and
encourages questions and expression of concerns on quality issues to management. Eurofins
recognizes that the implementation of a quality assurance program requires management’s
commitment and support as well as the involvement of the entire staff
 Continually improve systems and manage risk to support quality improvement efforts in
laboratory, administrative and managerial activities.
7.2 Ethics and Data Integrity
Eurofins Environment Testing is committed to ensuring the integrity of its data and meeting the
quality needs of its clients. The laboratory operates its Ethics and Data Integrity program under
the guidance of Eurofins’ Key Guidance Document (KGD). The elements of the program include:
 An Ethics Policy (NDSC Document No. SOP01-QA-QP5252) and Employee Ethics
Statements.
 Ethics and Compliance Officer/s (ECOs).
 A Training Program.
 Self-governance through disciplinary action for violations.
 A confidential mechanism for anonymously reporting alleged misconduct and a means for
conducting internal investigations of all alleged misconduct. (NDSC Document No. QA-
QP38228).
 Procedures and guidance for recalling data if necessary (NDSC Document No. QA-
QP38229).
 Effective external and internal monitoring system that includes procedures for intern al audits
(laboratory SOP No. WS-QA-0036, Internal Auditing).
 Produce results, which are accurate and include QA/QC information that meets client pre -
defined Data Quality Objectives (DQOs).
 Present services in a confidential, honest and forthright manner.
 Provide employees with guidelines and an understanding of the Ethical and Quality Standards
of our Industry.
 Provide procedures and guidance to ensure the impartiality and confidentiality of all data and
customer information.
 Operate our facilities in a manner that protects the environment and the health and safety of
employees and the public.
 Obey all pertinent federal, state and local laws and regulations and encourage other members
of our industry to do the same.
 Educate clients as to the extent and kinds of services available.
 Assert competency only for work for which adequate personnel and equipment are available
and for which adequate preparation has been made.
 Promote the status of environmental laboratories, their employees, and the value of services
rendered by them.
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7.3 Quality System Documentation
The laboratory’s Quality System is communicated through a variety of documents.
 Quality Assurance (QA) Manual – Each laboratory has a lab-specific QA manual.
 NDSC Official Documents – Each laboratory may use the Guidance (instructional use)
documents at their discretion. Template documents are process documents that the
laboratory’s need to implement locally by using the document as is or as an outline to define
their internal practices that meet the minimum requirements of the template. Required
documents need to be implemented as is and listed in the laboratory’s document control list.
 Key Guidance Documents (KGDs) - Documents compiled at the Group Service Centre (GSC)
level by Functional Leaders (document owners) aimed at providing specific Eurofins groups
of employees with guidelines necessary for the good conduct of their respective work.
 Laboratory SOPs and Policies – General and Technical
 Work Instructions – A subset of procedural steps, tasks or forms associated with an operation
of a management system (e.g., checklists, preformatted bench sheets, forms).
7.3.1 Order of Precedence
In the event of a conflict or discrepancy between policies, the order of precedence is as follows:
 NDSC Guidance Documents
 KGDs
 Laboratory Quality Assurance Manual (QA Manual)
 Laboratory SOPs and Policies
 Other (Work Instructions (WI), memos, flow charts, etc.)
NOTE: The laboratory has the responsibility and authority to operate in compliance with regulatory
requirements of the jurisdiction in which the work is performed.
7.4 QA/QC Objectives for the Measurement of Data
Quality Assurance (QA) is responsible for developing planned activities whose purpose is to
provide assurance to all levels of management that a quality program is in place within the
laboratory, and that it is functioning in an effective manner that is consistent with the requirements
of NELAP, ISO 17025, DoD, PALA1, and any other regulatory agencies (i.e., states) in which the
laboratory maintains accreditation.
Quality Control (QC) is generally understood to be limited to the analyses of samples and to be
synonymous with the term “analytical quality control”. QC refers to the routine application of
statistically based procedures to evaluate and control the accuracy of results from analytical
measurements. The QC program includes procedures for estimating and controlling precision
and bias and for determining reporting limits.
Request for Proposals (RFPs) and Quality Assurance Project Plans (QAPP) provide a mechanism
for the client and the laboratory to discuss the data quality objectives in order to ensure that
analytical services closely correspond to client needs. In order to ensure the ability of the
laboratory to meet the Data Quality Objectives (DQOs) specified in the QAPP, clients are advised
to allow time for the laboratory to review the QAPP before being finalized. The client is
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responsible for developing the QAPP; however, the laboratory will provide support to the client
for developing the sections of the QAPP that concern laboratory activities.
Historically, laboratories have described their QC objectives in terms of precision, accuracy,
representativeness, comparability, completeness, selectivity and sensitivity (PARCCSS). Each
laboratory SOP defines the required QC indicators.
7.4.1 Precision
The objective is to meet the performance for precision demonstrated for the methods on similar
samples and to meet DQOs of the EPA and/or other regulatory programs. Precision is defined as
the degree of reproducibility of measurements under a given set of analytical conditions (exclusive
of field sampling variability). In laboratory reports, batch precision is commonly expressed in terms
of relative percent difference (RPD) for replicate pairs of measurements (e.g., matrix spike/matrix
spike duplicates) or relative standard deviation (RSD) for more than two replicates.
7.4.2 Accuracy
The objective is to meet the performance for accuracy demonstrated for the methods on similar
samples and to meet DQOs of the EPA and/or other regulatory programs. Accuracy is defined as
the degree of bias in a measurement system. Accuracy includes a combination of random error
(precision) and systematic error (bias) components that are due to sampling and analytical
operations. Accuracy is commonly expressed by the laboratory as a percent recovery of
analytical spikes (fortified samples) and may be documented through the use of laboratory control
samples (LCS) and/or MS. A statement of accuracy is expressed as an interval of acceptance
recovery about the mean recovery.
7.4.3 Representativeness
The objective is to provide data which is representative of the sampled medium.
Representativeness is defined as the degree to which data represent a characteristic of a
population or set of samples and is a measurement of both analytical and field sampling precision.
The representativeness of the analytical data is a function of the procedures used in procuring
and processing the samples. The representativeness can be documented by the relative percent
difference between separately procured, but otherwise identical samples or sample aliquots.
The representativeness of the data from the sampling sites depends on both the sampling
procedures and the analytical procedures. Refer to laboratory SOPs for subsampling and
homogenization techniques appropriate to the analytical method.
7.4.4 Comparability
The objective is to provide analytical data for which the accuracy, precision, representativeness,
and reporting limit statistics are similar to these quality indicators generated by other laboratories
for similar samples, and data generated by the laboratory over time. To ensure comparability,
project plans typically require the use of methods approved by EPA or other standards setting
bodies. Within the laboratory, analysts are required to use uniform procedures (e.g., SOPs) and
a uniform set of units and calculations for analyzing and reporting environmental data.
Comparability is documented by inter-laboratory studies carried out by regulatory agencies or
carried out for specific projects or contracts, by comparison of periodically generated statements
of accuracy, precision, and reporting limits with those of other laboratories.
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7.4.5 Completeness
The completeness objective for data is 90% (or as specified by a particular project), expressed
as the ratio of the valid (or useable) data to the total data over the course of the project. Data will
be considered valid if they are adequate for their intended use. Data usability will be defined in a
QAPP, project scope, or regulatory requirement. Examples of factors negatively affecting
completeness include the following: sample leakage or breakage in transit or during handling,
loss of sample during laboratory analysis, improper documentation such that traceability is
compromised, or the sample result is rejected due to failure to conform to QC specifications. Data
validation is the process for reviewing data to determine its usability and completeness. If the
completeness objective is not met, actions will be taken internally and with the data user to
improve performance. This may take the form of an audit to evaluate the methodology and
procedures as possible sources for the difficulty or may result in a recommendation to use a
different method.
7.4.6 Selectivity
Selectivity is defined as the capability of a test method or instrument to respond to a target
substance or constituent in the presence of non-target substances. Target analytes are separated
from non-target constituents and subsequently identified/detected through one or more of the
following, depending on the analytical method: extractions (separation), digestions (separation),
interelement corrections (separation), use of matrix modifiers (separation), specific retention times
(separation and identification), confirmations with different columns or detectors (separation and
identification), specific wavelengths (identification), specific mass spectra (identif ication), and
specific electrodes (separation and identification).
7.4.7 Sensitivity
Sensitivity refers to the amount of analyte necessary to produce a detector response that can be
reliably detected (above the Method Detection Limit) or quantified (above the Reporting Limit).
7.5 Criteria for Quality Indicators
The laboratory maintains tables, housed in LIMS that summarize the precision and accuracy
acceptability limits for performed analyses. This summary includes an effective date, is updated
each time new limits are generated, and are managed by the laboratory’s QA department. Unless
otherwise noted, limits within these tables are laboratory generated. Some acceptability limits are
derived from US EPA methods when they are required. Where US EPA method limits are not
required, the laboratory has developed limits from evaluation of data from similar matrices.
Criteria for development of control limits are contained in SOP WS-QA-0035, Statistical Process
Control/Control Chart and Section 26.
7.6 Statistical Quality Control
Statistically-derived precision and accuracy limits are required by selected methods (such as SW-
846) and programs. The laboratory routinely utilizes statistically-derived limits to evaluate method
performance and determine when corrective action is appropriate. The analysts use the current
limits entered into LIMS. The QA department maintains an archive of all limits used within the
laboratory. If a method defines the QC limits, the method limits are used.
If a method requires the generation of historical limits, the lab develops such limits from recent
data in the QC database of LIMS following the guidelines described in WS-QA-0035, Statistical
Process Control/Control Chart and Section 26. All calculations and limits are documented and
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dated when approved and effective. On occasion, a client requests contract-specified limits for a
specific project.
Current QC limits are entered and maintained in the LIMS analyte database. As sample results
and the related QC are entered into LIMS, the sample QC values are compared with the limits in
LIMS to determine if they are within the acceptable range. The analyst then evaluates if the
sample needs to be rerun or re-extracted/rerun or if a comment should be added to the report
explaining the reason for the QC outlier.
7.6.1 QC Charts
As the QC limits are calculated, QC charts are generated showing warning and control limits for
the purpose of evaluating trends. The QA Manager evaluates these to determine if adjustments
need to be made or for corrective actions to methods. All findings are documented and kept on
file. Control charts are generated according to laboratory SOP No. SOP WS-QA-0035, Statistical
Process Control/Control Chart.
7.7 Quality System Metrics
In addition to the QC parameters discussed above, the entire Quality System is evaluated on a
monthly basis through the use of specific metrics (refer to Section 18). These metrics are used to
drive continuous improvement in the laboratory’s Quality System.
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8.0 DOCUMENT CONTROL
8.1 Overview
The QA Department is responsible for the control of documents used in the laboratory to ensure
that approved, up-to-date documents are in circulation and out-of-date (obsolete) documents are
archived or destroyed. The following documents, at a minimum, must be controlled:
 Laboratory Quality Assurance (QA) Manual
 Laboratory Standard Operating Procedures (SOP)
 Laboratory Policies
 Work Instructions and Forms
 NDSC Documents1
1Includes locally implemented documents that are document controlled within the laboratory’s
document control system.
The security and control of documents is essential to ensure that confidential information is not
distributed and that all current copies of a given document are from the late st approved revision.
Unambiguous identification of a controlled document is maintained by identification of the
following items in the document header: Document Number, Revision Number, Effective Date,
and Number of Pages. Controlled documents are authorized by Management and/or the QA
Department. Controlled documents are marked as such, and records of their distribution are
maintained by the QA Department. Document control may be achieved by either electronic or
hardcopy distribution.
The NDSC documents are only considered controlled when they are read on the intranet site.
Printed copies are considered uncontrolled unless the laboratory physically distributes them as
controlled documents. The laboratory’s internal document control procedure is defined in SOP
No. WS-QA-0021, Preparation and Management of Standard Operating Procedures.
The laboratory QA Department also maintains access to various references and document
sources integral to the operation of the laboratory. This includes reference methods and
regulations. Instrument manuals (hard or electronic copies) are also maintained by the laboratory.
The laboratory maintains control of records for raw analytical data and supporting records such as
audit reports and responses, logbooks, standard logs, training files, MDL studies, Proficiency
Testing (PT) studies, certifications and related correspondence, and corrective action reports.
Raw analytical data consists of bound logbooks, instrument printouts, any other notes, magnetic
media, electronic data, and final reports.
8.2 Document Approval and Issue
The pertinent elements of the document control system includes a unique document title and
number, pagination, the total number of pages of the item or an ‘end of document’ page, the
effective date, revision number, and the laboratory’s name. The QA personnel are responsible
for the maintenance of this system.
Controlled documents are authorized by the QA Department. In order to develop a new document,
a responsible manager submits an electronic draft to the QA Department for suggestions and
approval before use. Upon approval, QA personnel add the identifying version information to the
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document and retain that document as the official document on file. That document is then
provided to all applicable operational units. Controlled documents are identified as such and
records of their distribution are kept by the QA Department. Document control may be achieved
by either electronic or hardcopy distribution.
The QA Department maintains a list of the official versions of controlled documents.
Quality System Policies and Procedures will be reviewed at a minimum of every two years
(annually for documents applicable to drinking water and DoD/DOE programs) and revised as
appropriate. Changes to documents occur when a procedural change warrants.
8.3 Procedures for Document Control Policy
For changes to the QA Manual, refer to SOP No. WS-QA-0021, Preparation and Management of
Standard Operation Procedures. Uncontrolled copies must not be used within the laboratory.
Previous revisions and back-up data are stored by the QA department. Electronic copies are
stored on the QA share on the local server for the applicable revision, and are accessible using
the laboratory’s Intranet
For changes to SOPs, refer to SOP No. WS-QA-0021, Preparation and Management of Standard
Operating Procedures. The SOP identified above also defines the process of changes to SOPs.
Forms, worksheets, work instructions and information are organized by department in the QA
office. There is a table of contents. Electronic versions are kept on the networked QA fileshare;
hard copies are kept in QA files. The procedure for the care of these documents is in SOP WS-
QA-0037, Document Control.
8.4 Obsolete Documents
All invalid or obsolete documents are removed, or otherwise prevented from unintended use. The
laboratory has specific procedures as described above to accomplish this. In general, obsolete
documents are collected from employees according to distribution lists and are marked obs olete
on the cover or destroyed. At least one copy of the obsolete document is archived according to
SOP No. WS-QA-0021, Preparation and Management of Standard Operating Procedures.
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9.0 SERVICE TO THE CLIENT
9.1 Overview
The laboratory has established procedures for the review of work requests and contracts, oral or
written. The procedures include evaluation of the laboratory’s capability and resources to meet
the contract’s requirements within the requested time period. All requirement s, including the
methods to be used, must be adequately defined, documented and understood. For many
environmental sampling and analysis programs, testing design is site or program s pecific and
does not necessarily fit into a standard laboratory service or product. It is the laboratory’s intent
to provide both standard and customized environmental laboratory services to our clients.
A thorough review of technical and QC requirements contained in contracts is performed to
ensure project success. The appropriateness of requested methods, and the lab’s capability to
perform them must be established. Projects, proposals, and contracts are reviewed for adequately
defined requirements and the laboratory’s capability to meet those requirements. Alternate test
methods that are capable of meeting the clients’ requirements may be proposed by the lab. A
review of the lab’s capability to analyze non-routine analytes is also part of this review process.
All projects, proposals and contracts are reviewed for the client’s requirements in terms of
compound lists, test methodology requested, sensitivity (detection and reporting levels),
accuracy, and precision requirements (% Recovery and RPD). The reviewer ensures that the
laboratory’s test methods are suitable to achieve these requirements and that the laboratory holds
the appropriate certifications and approvals to perform the work. The laboratory and any potential
subcontract laboratories must be certified, as required, for all proposed tests.
Electronic or hard copy deliverable requirements are evaluated against the laboratory’s capacity
for production of the documentation.
If the laboratory cannot provide all services but intends to subcontract such services, whether to
another Eurofins facility on the same LIMS or to an outside firm, this will be documented and
discussed with the client prior to contract approval. (Refer to Section 10 for Subcontracting
Procedures.)
The laboratory informs the client of the results of the review if it indicates any potential conflict,
deficiency, lack of accreditation, or inability of the lab to complete the work satisfactorily. Any
discrepancy between the client’s requirements and the laboratory’s capability to meet those
requirements is resolved in writing before acceptance of the contract. It is necessary that the
contract be acceptable to both the laboratory and the client. Amendments initiated by the client
and/or Eurofins Sacramento are documented in writing.
All contracts, QAPPs, Sampling and Analysis Plans (SAPs), contract amendments, and
documented communications become part of the project record.
The same contract review process used for the initial review is repeated when there are
amendments to the original contract by the client, and the participating personnel are informed of
the changes.
9.2 Review Sequence and Key Personnel
Appropriate personnel will review the work request at each stage of evaluation.
For routine projects and other simple tasks, a review by the Project Manager (PM) is considered
adequate. The PM confirms that the laboratory has any required certifications, that it can meet
the clients’ data quality and reporting requirements and that the lab has the capacity to meet the
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clients turn around needs. The PM will also get approval by the Laboratory Director to commit to
delivery schedules that are shorter than the published standard turnaround times (TATs). The
Laboratory Director updates these TATs on a routine basis, and it is the responsibility of CSMs
and PMs to review them prior to making commitments for the laboratory.
It is recommended that, where there is a sales person assigned to the account, an attempt should
be made to contact that sales person to inform them of the incoming samples.
For new, complex or large projects, the proposed contract is given to the Client Relationship
Manager or Proposal Team, who will decide which lab will receive the work based on the scope
of work and other requirements, including certification, testing methodology, and available
capacity to perform the work. .
This review encompasses all facets of the operation. The scope of work is distributed to the
appropriate personnel, as needed based on scope of contract, to evaluate all of the requirements
shown above (not necessarily in the order below):
 Contract Administrator
 Client Relations Manager
 Laboratory Project Manager
 Laboratory Directors and/or NDSC Technical Directors
 Account Executives
 Quality Managers
 Laboratory Environmental Health and Safety Managers/Coordinators
New contracts and purchase orders are forwarded to the “Legal-Contract Review” email group for
formal review and comments. Changes are negotiated by Project Managers or the Client
Relations Manager. When all negotiations are concluded, The Laboratory Director reviews the
formal laboratory quote and makes final acceptance for the facility. The Sales Director, Contract
Administrator, Account Executive or Proposal Coordinator then submits the final proposal to the
client. Once signed by the client, local contracts are stored on the laboratory fileshare, and
national contracts are stored on EETA Net.
In the event that one of the above personnel is not available to review the contract, his or her
back-up will fulfill the review requirements.
9.3 Balancing Laboratory Capacity and Workload
Evaluating laboratory capacity to perform specific projects is the responsibility of the Laboratory
Directors and Managers, and the Client Services director and manager. Many analysts are cross-
trained to perform a variety of tests, and there is redundant equipment available in case of
malfunctions. This minimizes the need to evaluate small and medium size projects against
capacity available to complete them. Large and complex projects are reviewed against capacity
estimates before bids are submitted to ensure that the client’s analysis schedule is met. Regularly
scheduled meetings are held between laboratory management, PMs, Client Services and QA
personnel to review progress with current projects, as well as special requirements of new work
scheduled for the laboratory. Laboratory capacity and backlog is tracked on a continuous basis
using information from the Laboratory Sample Information System (LIMS) including turnaround
time, and work in-house.
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9.4 Documentation
The Contracts Department maintains copies of all signed contracts. The Sacramento laboratory’s
Customer Service Organization maintains copies of all signed contracts on the computer network
for reference locally.
Appropriate records are maintained for every contract or work request. All stages of the contract
review process are documented and include records of any significant changes. These records
are archived by client and project in a restricted network folder accessible to laboratory
department managers, project managers, and senior managers.
Records are maintained of pertinent discussions with a client relating to the client’s requirements
or the results of the work during the period of execution of the contract. Each Laboratory Project
Manager keeps a phone log of conversations with the client. In addition, all conversations
involving notification of important information, or actions directed by the client are documented
with a follow up e-mail and archived in the contracts folder or the SDG documentation and case
narrative. Instances include change in scope, alterations to the requests listed on a chain of
custody, directions to proceed in the event of a non-conformance, and any other conversation
that changes the direction of a COC or contract.
9.4.1 Project-Specific Quality Planning
Communication of contract specific technical and QC criteria is an essential activity in ensuring
the success of site specific testing programs. To achieve this goal, a PM is assigned to each
client. It is the PM’s responsibility to ensure that project-specific technical and QC requirements
are effectively evaluated and communicated to the laboratory personnel before and during the
project. QA department involvement may be needed to assist in the evaluation of custom QC
requirements.
PM’s are the primary client contact and they ensure resources are available to meet project
requirements, they coordinate opportunities and work with laboratory management and supervisory
staff to ensure available resources are sufficient to perform work for the client’s project.
Prior to work on a new project, the dissemination of project information and/or project opening
meetings may occur to discuss schedules and unique aspects of the project. Items to be discussed
may include the project technical profile, turnaround times, holding times, methods, analyte lists,
reporting limits, deliverables, sample hazards, or other special requirements. The PM introduces
new project information to maximize production and client satisfaction, while maintaining quality. I,
Project notes may be associated with each sample batch as a reminder upon sample receipt and
analytical processing.
Any change that may occur within an active project is agreed upon between the client/regulatory
agency and the PM/laboratory. These changes (e.g., use of a non-standard method or modification
of a method) and approvals must be documented prior to implementation. Documentation pertains
to any document (e.g., letter, e-mail, variance, contract addendum), which has been signed by both
parties.
Such changes are also communicated to the laboratory via project notes and method comments in
LIMS as well as during production meetings. Such changes are updated to the project notes and
are introduced to the managers at these meetings. The laboratory staff is then introduced to the
modified requirements via the PM or the individual laboratory Department Manager, supervisor, or
lead analyst. . After the modification is implemented into the laboratory process, documentation of
the modification is made in the case narrative of the data report(s).
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The laboratory strongly encourages client visits to the laboratory and for formal/inf ormal
information sharing session with employees in order to effectively communicate ongoing client
needs as well as project specific details for customized testing programs.
9.5 Special Services
The laboratory cooperates with clients and their representatives to monitor the laboratory’s
performance in relation to work performed for the client. It is the laboratory’s goal to meet all client
requirements in addition to statutory and regulatory requirements. The laboratory has procedures
to ensure confidentiality to clients (Section 17 and 25).
The laboratory’s standard procedures for reporting data are described in Section 25. Special
services are also available and provided upon request. These services include:
 Reasonable access for our clients or their representatives to the relevant areas of the
laboratory for the witnessing of tests performed for the client.
 Assisting client-specified third party data validators as specified in the client’s contract.
 Supplemental information pertaining to the analysis of their samples. Note: An additional
charge may apply for additional data/information that was not requested prior to the time of
sample analysis or previously agreed upon.
When the client requests a statement of conformity to a specif ication or standard based on the
analysis performed by the laboratory (e.g., pass/fail, in-tolerance/out-of-tolerance), the decision
rule shall be clearly defined. Unless inherent in the requested specification or standard, the
decision rule selected shall be communicated to the client. Associated reporting requirements are
addressed in Section 25.2.18.
9.6 Client Communication
PMs are the primary communication link to the clients. They shall inform their clients of any delays
in project completion as well as any non-conformances in either sample receipt or sample
analysis. Project management will maintain ongoing client communication throughout the entire
client project.
Technical Managers are available to discuss any technical questions or concerns that the client
may have.
9.7 Client Confidentiality
Data and sample materials provided by the client or at the client’s request, and the results
obtained by Eurofins Sacramento, shall be held in confidence (unless such information is
generally available to the public or is in the public domain) subject to any disclosure required by
law or legal process. Eurofins Sacramento will not intentionally divulge to any person (other than
the Client or any other person designated by the Client in writing) any information regarding the
services provided by Eurofins Sacramento or any information disclosed to Eurofins Sacramento
by the Client. Furthermore, information known to be potentially endangering to national security
or an entity’s proprietary rights will not be released.
Note: This shall not apply to the extent that the information is required to be disclosed by Eurofins
Sacramento under the compulsion of legal process. Eurofins Sacramento will, to the extent
feasible, provide reasonable notice to the client before disclosing the information.
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9.8 Reporting
The laboratory works with our clients to produce any special communication reports required by
the contract.
9.9 Client Feedback and Surveys
The laboratory assesses both positive and negative client feedback. The results are used to
improve overall laboratory quality and client service. Eurofins Sales and Marketing teams
periodically develop lab and client specific surveys to assess client satisfaction. Client satisfaction
surveys are sent with every report.
When a complaint is received, we determine, to the best of our ability, the extent of the issue and
what data is in question. The person receiving the complaint documents this information and
promptly forwards it to the appropriate management personnel where the work in question was
performed. If a data reporting error is discovered, the final report and/or data must be regenerated
with the correct value(s).
The project manager or QA is responsible for entering client concerns into ICAT. In some cases,
an ICAT / ICAR (Investigation and Corrective Action Report) is initiated to address and document
the situation. While an individual issue may not warrant a formal investigation, QA monitors these
issues for potential trends and will issue an ICAR/ICAT if a trend is evident.
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10.0 SUBCONTRACTING OF TESTS
10.1 Overview
For the purpose of this quality manual, the phrase subcontract laboratory refers to a laboratory
external to the Eurofins Environment Testing (EET) laboratories. The phrase “work sharing” refers
to internal transfers of samples between the EET laboratories. The term outsourcing refers to the
act of subcontracting tests.
When contracting with our clients, the laboratory makes commitments regarding the services to
be performed and the data quality for the results to be generated. When the need arises to
outsource testing for our clients because project scope, changes in laboratory capabilities,
capacity, or unforeseen circumstances, we must be assured that the subcontractors or work
sharing laboratories understand the requirements and will meet the same commitments we have
made to the client. Refer to the NDSC Document on Subcontracting Procedures (NDSC-US-SUB-
SOP44936).
When outsourcing analytical services, the laboratory will assure, to the extent necessary, that the
subcontract or work sharing laboratory maintains a program consistent with the requirements of
this document, the requirements specified in TNI/ISO 17025 and/or the client’s Quality Assurance
Project Plan (QAPP). All QC guidelines specific to the client’s analytical program are transmitted
to the subcontractor and agreed upon before sending the samples to the subcontract facility.
Additionally, work requiring accreditation will be placed with an appropriately accredited
laboratory. The laboratory performing the subcontracted work will be identified in the final report,
as will non-TNI accredited work where required.
PMs or other responsible Client Service members, for the Export Lab (i.e., the Eurofins laboratory
that transfers samples to another laboratory) are responsible for obtaining client approval prior to
subcontracting any samples. The laboratory will advise the client of a subcontract arrangement in
writing and when possible approval from the client shall be obtained and retained in the project
folder. Standard Eurofins Sacramento Terms & Conditions include the flexibility to subcontract
samples within the EET laboratories. Therefore, additional advance notification to clients for intra-
laboratory subcontracting is not necessary unless specifically required by a client contract.
Note: In addition to the client, some regulating agencies (e.g., USDA) or contracts (e.g., DoD and
DOE projects) require notification prior to placing such work. Documentation of approval is stored
electronically in the quote folder within SACSALES share on a local laboratory server. If the
approval is specific to a single laboratory login or job, the approval is stored in the LIMS with the
login information.
10.2 Qualifying and Monitoring Subcontractors
Whenever a PM or Client Relationship Manager becomes aware of a client requirement or
laboratory need where samples must be outsourced to another laboratory, the other laboratory(s)
shall be selected based on the following:
 Subcontractors specified by the client - In these circumstances, the client assumes
responsibility for the quality of the data generated from the use of a subcontractor.
 Subcontractors reviewed by EET-NDSC – Firms which have been reviewed by the company
and are known to meet standards for accreditations (e.g., State, TNI and DoD/DOE); technical
specifications; legal and financial information.
A listing of vendors is available on the EET sharepoint site.
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All EET laboratories are pre-qualified for work sharing provided they hold the appropriate
accreditations and can adhere to the project/program requirements. In these cases, the client
must provide acknowledgement that the samples can be sent to that facility (an e-mail is sufficient
documentation or if acknowledgement is verbal, the date, time, and name of person providing
acknowledgement must be documented). The originating laboratory is responsible for
communicating all technical, quality, and deliverable requirements as well as other contract
needs.
10.2.1 When the potential subcontract laboratory has not been previously approved, Account
Executives or PMs may nominate a laboratory as a subcontractor based on need. The decision
to nominate a laboratory must be approved by the Client Relations Manager (CRM) or Laboratory
Director. The CRM or Laboratory Director requests that the PM begin the process of approving
the subcontract laboratory. Refer to the NDSC Document No. NDSC-US-SUB-SOP44936,
Subcontracting Procedures.
Once the appropriate accreditation and legal information is received by the laboratory, it is
evaluated for acceptability and forwarded to the NDSC Quality Information Manager (QIM) for
review. After the NDSC QIM reviews the documents for completeness, the information is
forwarded to the Finance Department for formal signature and contracting with the laboratory.
The approved vendor will be added to the approved subcontractor list on the intranet site, and the
finance group is concurrently notified.
The client will assume responsibility for the quality of the data generated from the use of a
subcontractor they have requested the lab to use. The qualified subcontractors on the intranet
site are known to meet minimal standards. EET does not certify laboratories. The subcontractors
on our approved list can only be recommended to the extent that we would use them.
10.3 Oversight and Reporting
The status and performance of qualified subcontractors will be monitored by NDSC, and includes
an annual review process (ref.: NDSC Document No. SOP NDSC-US-SUB-SOP44936. Any
problems identified will be brought to the attention of NDSC:
 Complaints shall be investigated. Documentation of the complaint, investigation, and
corrective action will be maintained in the subcontractor’s file on the intranet site. Complaints
are posted using the Vendor Performance Report.
 Information shall be updated on the intranet when new information is received from the
subcontracted laboratories.
 Subcontractors in good standing will be retained on the intranet listing. Client Service
personnel will notify all EET laboratories, NDSC, and Corporate Contracts if any laboratory
requires removal from the intranet site. This notif ication will be posted on the intranet site and
e-mailed to all Client Service/CSO Personnel, Laboratory Directors, QA Managers, and Sales
Personnel.
Prior to initially sending samples to the subcontracted laboratory, the PM confirms their
certification status to determine if it is current and scope-inclusive. The information is documented
within the project records.
The laboratory’s certifications are available on request. They are stored on the QA fileshare and
in the LIMS.
10.3.1 All subcontracted samples must be accompanied by a Eurofins Sacramento Chain of
Custody (COC). A copy of the original COC sent by the client must be available in LIMS for all
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samples workshared within EET. Client COCs are only forwarded to external subcontractors when
samples are shipped directly from the project site to the subcontractor lab. Under routine
circumstances, client COCs are not provided to external subcontractors.
Through communication with the subcontracted laboratory, the PM monitors the status of the
subcontracted analyses, facilitates successful execution of the work, and ensures the timeliness
and completeness of the analytical report.
Non-TNI accredited work must be identified in the subcontractor’s report as appropriate. If TNI
accreditation is not required, the report does not need to include this information.
Reports submitted from subcontractor laboratories are not altered and are included in their original
form in the final project report. This clearly identifies the data as being produced by a
subcontractor facility. If subcontract laboratory data is incorporated into the laboratory’s EDD
(i.e., imported), the report must explicitly indicate which lab produced the data for which methods
and samples.
Note: The results submitted by an EET work sharing laboratory may be transferred
electronically and the results reported by the EET work sharing lab are identified on the final
report. The report must explicitly indicate which lab produced the data for which methods and
samples. The final report must include a copy of the completed COC for all work sharing reports.
10.4 Contingency Planning
The full qualification of a subcontractor may be waived to meet emergency needs. This decision
and justification must be documented in the project files, and the ‘Purchase Order Terms and
Conditions for Subcontracted Laboratory Services’ must be sent with the samples and COC. In
the event this provision is utilized, the laboratory (e.g., PM) will be required to verify and document
the applicable accreditations of the subcontractor. All other quality and accreditation requirements
will still be applicable, but the subcontractor need not have signed a subcontract agreement with
EET at this time.
The use of any emergency subcontractor will require the PM to complete a New Vendor Add Form
in order to process payment to the vendor and add them to LIMS. This form requires the user to
define the subcontractor’s category/s of testing and the reason for testing.
10.5 Use of NELAP and Accrediting Body Logo
It is not laboratory policy to use these logos on any company letterhead, including analytical
reports.
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11 .0 PURCHASING SERVICES AND SUPPLIES
11.1 Overview
Evaluation and selection of suppliers and vendors is performed, in part, on the basis of the quality
of their products, their ability to meet the demand for their products on a continuous and short
term basis, the overall quality of their services, their past history, and competitive pricing. This is
achieved through evaluation of objective evidence of quality furnished by the supplier, which can
include certificates of analysis, recommendations, and proof of historical compliance with similar
programs for other clients. To ensure that quality critical consumables and equipment conform to
specified requirements, which may affect quality, all purchases from specific vendors are
approved by a member of the supervisory or management staff. Capital expenditures are
approved by Eurofins Environment Testing, and are made in accordance with the guidelines
presented on the EET-NET/Finance sharepoint.
Contracts will be signed in accordance with Eurofins Environment Testing’s Spending & Contract
Authority Policies as maintained on the EET-NET/Finance sharepoint. Request for Proposals
(RFP’s) will be issued where more information is required from the potential vendors than just
price. Process details are available on the EET-NET/Finance sharepoint. RFP’s allow the
laboratory to determine if a vendor is capable of meeting requirements such as supplying all of
the laboratory facilities, meeting required quality standards and adhering to necessary ethical and
environmental standards. The RFP process also allows potential vendors to outline any additional
capabilities they may offer.
11.2 Glassware
Glassware used for volumetric measurements must be Class A or verified for accuracy according
to laboratory procedure. Pyrex (or equivalent) glass should be used where possible. For safety
purposes, thick-wall glassware should be used where available.
11.3 Reagents, Standards & Supplies
Purchasing guidelines for equipment, consumables, and reagents must meet the requirements of
the specific method and testing procedures for which they are being purchased. Solvents and
acids are pre-tested in accordance with NDSC Document No. NDSC-QA-SOP46704, Acid and
Solvent Testing and Approval Program. Approval information for the solvents and acids tested
under Document No. NDSC-QA-SOP46704 is stored on the laboratory’s SharePoint site, under
Solvent Approvals. A master list of all tested materials, as well as the certif icates of analysis for
the materials, is stored in the same location.
11.3.1 Purchasing
Chemical reagents, solvents, glassware, and general supplies are ordered as needed to maintain
sufficient quantities on hand. Materials used in the analytical process must be of a known quality.
The wide variety of materials and reagents available makes it advisable to specify
recommendations for the name, brand, and grade of materials to be used in any determination.
This information is contained in the method SOP. Many items used routinely are pre-qualified
and placed into the on-site consignment system. The analyst may check the item out of the on-
site consignment system that contains items approved for laboratory use.
For items not available from the consignment system or items that are not used routinely, an order
is placed in the ordering system. Only personnel trained in the ordering program may place orders
using the program. The analyst must provide the item description, package size, and quantity
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needed to the ordering person. All relevant information, including quantity, must be entered into
the ordering program. Only approved vendors may be used. The Laboratory Director or designee
approves all orders placed in the ordering program.
11.3.2 Receiving
It is the responsibility of the analyst or department manager who placed the order to receive the
shipment. For items received for an on-site consignment system, the purchasing manager verifies
that the material received meets the quality level specified. This is documented by stamping the
packing slip with “Received” and the date. For materials that are outside of the on-site
consignment systems, it is the responsibility of the analyst who ordered the materials to document
the date materials were received. Once the ordered reagents or materials are received, the
analyst compares the information on the label or packaging to the original order to ensure that
the purchase meets the quality level specified. This is documented through the addition of the
received date and initials to the information present in the ordering system.
The purchasing manager verifies the lot numbers of received solvents and acids against the pre-
approval lists. If a received material is listed as unapproved, or is not listed, it is sequestered and
returned to the vendor. Alternatively, the laboratory may test the material for the intended use,
and if it is acceptable, document the approval on the approval list. Records of any testing
performed locally are maintained on the shared “public” folder on the computer network.
Materials may not be released for use in the laboratory until they have been inspected, verified
as suitable for use, and the inspection/verification has been documented.
Safety Data Sheets (SDSs) are available online through the Company’s intranet website. Anyone
may review these for relevant information on the safe handling and emergency precautions of on-
site chemicals.
11.3.3 Specifications
Methods used in the laboratory specify the grade of reagent that must be used in the procedure.
If the quality of the reagent is not specified, analytical reagent grade will be used. It is the
responsibility of the analyst to check the procedure carefully for the suitability of grade of reagent.
Chemicals must not be used past the manufacturer’s expiration date and must not be used past
the expiration time noted in a method SOP. If expiration dates are not provided, the laboratory
may contact the manufacturer to determine an expiration date.
The laboratory assumes a five year expiration date on inorganic dry chemicals and solvents
unless noted otherwise by the manufacturer or by the reference source method.
Chemicals/solvents should not be used past the manufacturer’s or SOP expiration date unless
verified as outlined below. See laboratory SOP No. WS-QA-0017, Standards and Reagent
Preparation and Quality Control Check Procedures, for standard verification procedures.
 An expiration date cannot be extended if the dry chemical/solvent is discolored or appears
otherwise physically degraded. In this case, the dry chemical/solvent must be discarded.
 Expiration dates can be extended if the dry chemical/solvent is found to be satisfactory based
on acceptable performance of quality control samples (Continuing Calibration Verif ication
(CCV), Blanks, Laboratory Control Sample (LCS), etc.).
 If the dry chemical/solvent is used for the preparation of standards, the expiration dates can
be extended 6 months if the dry chemical/solvent is compared to an unexpired independent
source in performing the method and the performance of the dry chemical/solvent is found to
be satisfactory. The comparison must show that the dry chemical/solvent meets CCV limits.
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The comparison studies are maintained on-file and available for review on the shared public
folder on the computer network.
Wherever possible, standards must be traceable to national or international standards of
measurement or to national or international reference materials. Records to that effect are
available to the user.
Compressed gases in use are checked for pressure and secure positioning daily. To prevent a
tank from going to dryness, or introducing potential impurities, the pressure should be closely
watched as it decreases to approximately 15% of the original reading, at which point it should be
replaced. For example, a standard sized laboratory gas cylinder containing 3,000 psig of gas
should be replaced when it drops to approximately 500 psig. The quality of the gases must meet
method or manufacturer specification or be of a grade that does not cause any analytical
interference.
Water used in the preparation of samples, standards or reagents must have a specific conductivity
of less than 1-µmho/cm (or specific resistivity of greater than 1.0 megohm-cm) at 25oC. The
specific conductivity is checked and recorded daily. If the water’s specific conductivity is greater
than the specified limit, the Facility Manager and appropriate Technical Managers must be notified
immediately in order to notify all departments, decide on cessation (based on intended use) of
activities, and make arrangements for correction.
The laboratory may purchase reagent grade (or other similar quality) water for use in the
laboratory. This water must be certified clean by the supplier for all target analytes or otherwise
verified by the laboratory prior to use. This verification is documented.
Standard lots are verified before first time use if the laboratory switches manufacturers or has
historically had a problem with the type of standard. See laboratory SOP No. WS-QA-0017,
Standards and Reagent Preparation and Quality Control Check Procedures, for standard QC
procedures.
Purchased bottleware used for sampling must be certified clean and the certificates must be
maintained. If uncertified sampling bottleware is purchased, all lots must be verified clean prior to
use. This verification must be maintained.
Each laboratory section maintains records of manufacturer’s certification and traceability
statements on the network. These records include date of receipt, lot number (when applicable),
and expiration date (when applicable). Incorporation of the item into the record indicates that the
analyst has compared the new certificate with the previous one for the same purpose and that no
difference is noted, unless approved and so documented by the Technical Manager or QA
Manager.
11.3.4 Storage
Reagent and chemical storage is important from the aspects of both integrity and safety. Light -
sensitive reagents may be stored in brown-glass containers. Storage conditions are per the
NDSC HSE Manual, Document No. NDSC-US EHS-QP46060, the local laboratory EH&S manual
addendum and method SOPs or manufacturer instructions.
11.4 Purchase of Equipment / Instruments / Software
When a new piece of equipment is needed, either for additional capacity or for replacing
inoperable equipment, the analyst or supervisor makes a supply request to the Technical
Manager and/or the Laboratory Director. If they agree with the request, a decision is made as to
which piece of equipment can best satisfy the requirements. The appropriate written requests
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are completed and purchasing places the order.
Upon receipt of a new or used piece of equipment, an identification name is assigned and added
to the equipment list. IT must also be notified so that they can synchronize the instrument for
back-ups. Its capability is assessed to determine if it is adequate or not for the specific application.
For instruments, a calibration curve is generated, followed by MDLs, Demonstration of
Capabilities (DOCs), and other relevant criteria (refer to Section 20). For software, its operation
must be deemed reliable and evidence of instrument verif ication must be retained by the QA
Department. Software certificates supplied by the vendors are filed with the LIMS Administrator.
The manufacturer’s operation manual is retained at the bench and inventoried in the master
document list.
New support equipment such as weight sets, autopipettors, etc. must be accompanied by a
calibration certificate from a vendor with current and valid ISO 17025 accreditation for calibration
of the specific piece of equipment. If the equipment is not accompanied by such a certificate, it
must be withheld from service until it has been calibrated by an approved vendor with the
appropriate accreditation.
11.5 Services
Service to analytical instruments (except analytical balances) is performed on an as needed basis.
Routine preventative maintenance is discussed in Section 22. The need for service is determined
by analysts and/or Technical Managers. The service providers that perform the services are
approved by the Technical Manager.
Analytical balances are serviced and calibrated annually in accordance with SOP No. WS-QA-
0041, Calibration and Calibration Check of Balances. The calibration and maintenance services
are performed on-site, and the balances are returned to use immediately following successful
calibration. Calibration certificates are filed for reference. If the calibration was unsuccessful, the
balance is immediately removed from service and segregated pending either further maintenance
or disposal.
Calibration services for support equipment such as thermometers, weight sets, autopipettors, etc.,
are obtained from vendors with current and valid ISO 17025 accreditation for calibration of the
specific piece of equipment. Prior to utilizing the vendor’s services, the vendor’s accreditation
status is verified. Once the equipment has been calibrated, the calibration certif icates are
reviewed by the QA department, and documentation of the review is filed with the calibration
certificates. The equipment is then returned to service within the laboratory
11.6 Suppliers
The laboratory selects vendors through a competitive proposal / bid process, strategic business
alliances or negotiated vendor partnerships (contracts).
The level of control used in the selection process is dependent on the anticipated spending
amount and the potential impact on the laboratory’s business. Vendors that provide test and
measuring equipment, solvents, standards, certified containers, instrument related service
contracts or subcontract laboratory services shall be subject to more rigorous controls than
vendors that provide off-the-shelf items of defined quality that meet the end use requirements.
The purchasing system includes all suppliers/vendors that have been approved for use.
Evaluation of suppliers is accomplished by ensuring the supplier ships the product or material
ordered and that the material is of the appropriate quality. This is documented by signing off on
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packing slips or other supply receipt documents. The purchasing documents contain the data that
adequately describe the services and supplies ordered.
Any issues of vendor performance are to be reported immediately by the laboratory staff to the
Purchasing Group by completing a Vendor Performance Report.
The Purchasing Group will work through the appropriate channels to gather the information
required to clearly identify the problem and will contact the vendor to report the problem and to
make any necessary arrangements for exchange, return authorization, credit, etc.
Suppliers are subject to re-evaluation, as deemed appropriate, through the use of Vendor
Performance Reports used to summarize and review to determine corrective action necessary,
or service improvements required by vendors
The laboratory has access to a listing of all approved suppliers of critical consumables, supplies
and services. This information is provided through the purchasing system.
11.6.1 New Vendor Procedure
Laboratory employees who wish to request the addition of a new vendor must complete a Vendor
Add Request Form.
New vendors are evaluated based upon criteria appropriate to the products or services provided
as well as their ability to provide those products and services at a competitive cost. Vendors are
also evaluated to determine if there are ethical reasons or potential conflicts of interest with
laboratory employees that would make it prohibitive to do business with them as well as their
financial stability. The QA Department and/or the Technical Services Director are consulted with
vendor and product selection that have an impact on quality.
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12.0 COMPLAINTS
12.1 Overview
The laboratory considers an effective client complaint handling processes to be of significant
business and strategic value. Listening to and documenting client concerns captures client
knowledge that enables our operations to continually improve processes and client satisfaction. An
effective client complaint handling process also provides assurance to the data user that the
laboratory will stand behind its data, service obligations and products.
A client complaint is any expression of dissatisfaction with any aspect of our business services
(e.g., communications, responsiveness, data, reports, invoicing and other functions) expressed
by any party, whether received verbally or in written form. Client inquiries, complaints or noted
discrepancies are documented, communicated to management, and addressed promptly and
thoroughly.
The laboratory has procedures for addressing both external and internal complaints with the goal
of providing satisfactory resolution to complaints in a timely and professional manner.
The nature of the complaint is identified, documented and investigated, and an appropriate action
is determined and taken. In cases where a client complaint indicates that an established policy
or procedure was not followed, the QA Department must evaluate whether a special audit must
be conducted to assist in resolving the issue. A written confirmation or letter to the client, outlining
the issue and response taken is recommended as part of the overall action taken.
The process of complaint resolution and documentation utilizes the procedures outlined in Section
14 (Corrective Actions) and is documented following laboratory policy WS-PQA-013, Procedure
to Address Customer Complaints. A copy of this procedure will be made available to any
interested party on request.
12.2 External Complaints
An employee that receives a complaint initiates the complaint resolution process by first
documenting the complaint according to laboratory policy WS-PQA-013, Procedure to Address
Customer Complaints.
Complaints fall into two categories: correctable and non-correctable. An example of a correctable
complaint would be one where a report re-issue would resolve the complaint. An example of a
non-correctable complaint would be one where a client complains that their data was repeatedly
late. Non-correctable complaints should be reviewed for preventive action measures to reduce
the likelihood of future occurrence and mitigation of client impact.
The general steps in the complaint handling process are:
 Receiving and documenting complaints
 Acknowledging receipt of complaint, whenever possible
 Complaint investigation and service recovery
 Process improvement
The laboratory shall inform the initiator of the complaint of the results of the investigation and the
corrective action taken, if any.
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12.3 Internal Complaints
Internal complaints include, but are not limited to: errors and non-conformances, training issues,
internal audit findings, and deviations from methods. Corrective actions may be initiated by any
staff member who observes a nonconformance and shall follow the procedures outlined in Section
14. In addition, Executive Management, Sales and Marketing and IT may initiate a complaint by
contacting the laboratory or through the corrective action system described in Section 14.
12.4 Management Review
The number and nature of client complaints is reported by the QA Manager to the Laboratory
Director and Quality Director in the QA Monthly report. Monitoring and addressing the overall
level and nature of client complaints and the effectiveness of the solutions is part of the Annual
Management Systems Review (Section 18).
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13.0 CONTROL OF NON-CONFORMING WORK
13.1 Overview
When data discrepancies are discovered or deviations and departures from laboratory SOPs,
policies and/or client requests have occurred, corrective action is taken immediately. First, the
laboratory evaluates the significance of the nonconforming work. Then, a corrective action plan is
initiated based on the outcome of the evaluation. If it is determined that the nonconforming work is
an isolated incident, the plan could be as simple as adding a qualifier to the final results and/or
making a notation in the case narrative. If it is determined that the nonconforming work is a systematic
or improper practices issue, the corrective action plan could include a more in depth investigation
and a possible suspension of an analytical method. In all cases, the actions taken are documented
using the laboratory’s corrective action system (refer to Section 14).
Due to the frequently unique nature of environmental samples, sometimes departures from
documented policies and procedures are needed. When an analyst encounters such a situation,
the problem is presented to the supervisor for resolution. The supervisor may elect to discuss it
with the Technical Manager or have a representative contact the client to decide on a logical
course of action. Once an approach is agreed upon, the analyst documents it using the
laboratories corrective action system described in Section 14. This information can then be
supplied to the client in the form of a footnote or a case narrative with the report.
Project Management may encounter situations where a client may request that a special
procedure be applied to a sample that is not standard lab practice. Based on a technical
evaluation, the lab may accept or opt to reject the request based on technical or ethical merit. An
example might be the need to report a compound that the lab does not normally report. The lab
would not have validated the method for this compound following the procedures in Section 21.
The client may request that the compound be reported based only on the calibration. Such a
request would need to be approved by the Technical Manager and QA Manager, documented
and included in the project folder. Deviations must also be noted on the final report with a
statement that the compound is not reported in compliance with TNI (or the analytical method)
requirements and the reason. Data being reported to a non-TNI state would need to note the
change made to how the method is normally run.
13.2 Responsibilities and Authorities
Under certain circumstances, the Laboratory Director, a Technical Manager, or a member of the
QA team may authorize departures from documented procedures or policies. The departures may
be a result of procedural changes due to the nature of the sample; a one-time procedure for a
client; QC failures with insufficient sample to reanalyze, etc. In most cases, the client will be
informed of the departure prior to the reporting of the data. Any departures must be well
documented using the laboratory’s corrective action procedures. This informat ion may also be
documented in logbooks and/or data review checklists as appropriate. Any impacted data must
be referenced in a case narrative and/or flagged with an appropriate data qualifier.
Any misrepresentation or possible misrepresentation of analytical data discovered by any
laboratory staff member must be reported to facility Senior Management within 24-hours. The
Senior Management staff is comprised of the Laboratory Director, the QA Manager, and the
Technical Managers. The reporting of issues involving alleged violations of the company’s Data
Integrity or Manual Integration procedures must be conveyed to an NDSC ECO (e.g., the VP-
QA/EHS) and the laboratory’s Quality Director within 24 hours of discovery.
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Whether an inaccurate result was reported due to calculation or quantitation errors, data entry
errors, improper practices, or failure to follow SOPs, the data must be evaluated to determine the
possible effect.
The Laboratory Director, QA Manager, ECOs, VP of Operations and the Quality Directors have the
authority and responsibility to halt work, withhold final reports, or suspend an analysis for due cause
as well as authorize the resumption of work.
13.3 Evaluation of Significance and Actions Taken
For each nonconforming issue reported, an evaluation of its significance and the level of
management involvement needed is made. This includes reviewing its impact on the final data,
whether or not it is an isolated or systematic issue, and how it relates to any special client
requirements.
The NDSC Document entitled Nonconforming Work (QA-QP38229) is the procedure to be
followed when it is discovered that erroneous or biased data may have been reported to clients
or regulatory agencies.
The NDSC Document entitled Internal Investigations (QA-QP38228) is the procedure to be
followed for investigation and correction of situations involved alleged incidents of misconduct or
violation of the company’s ethics policy.
Laboratory level decisions are documented and approved using the laboratory’s standard
nonconformance/corrective action reporting in lieu of the data recall determination form contained
in NDSC Document No. QA-QP38229.
13.4 Prevention of Nonconforming Work
If it is determined that the nonconforming work could recur, further corrective actions must be
made following the laboratory’s corrective action system. Periodically, as defined by the
laboratory’s preventive action schedule, the QA Department evaluates non-conformances to
determine if any nonconforming work has been repeated multiple times. If so, the laboratory’s
corrective action process may be followed.
13.5 Method Suspension / Restriction (Stop Work Procedures)
In some cases, it may be necessary to suspend/restrict the use of a method or target analyte
which constitutes significant risk and/or liability to the laboratory. Suspension/restriction
procedures can be initiated by any of the persons noted in Section 13.2, Paragraph 4.
Prior to suspension/restriction, confidentiality will be respected, and the problem with the required
corrective and preventive action will be stated in writing and presented to the Laboratory Director.
The Laboratory Director shall arrange for the appropriate personnel to meet with the QA Manager
as needed. This meeting shall be held to confirm that there is a problem, that
suspension/restriction of the method is required and will be concluded with a discussion of the
steps necessary to bring the method/target or test fully back on line. In some cases, that may not
be necessary if all appropriate personnel have already agreed there is a problem and there is
agreement on the steps needed to bring the method, target or test fully back on line. The QA
Manager will also initiate a corrective action report as described in Section 1 4 if one has not
already been started. A copy of any meeting notes and agreed upon steps should be e-mailed
by the laboratory to their Business Unit President; and the VP-QA & EHS. This e-mail acts as
notification of the incident.
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After suspension/restriction, the lab will hold all reports to clients pending review. No faxing,
mailing or distributing through electronic means may occur. The report must not be posted for
viewing on the internet. It is the responsibility of the Laboratory Director to hold all reporting and
to notify all relevant laboratory personnel regarding the suspension/restriction (e.g., Project
Management, Log-in, etc.). Clients will NOT generally be notified at this time. Analysis may
proceed in some instances depending on the non-conformance issue.
Within 72 hours, the QA Manager will determine if compliance is now met and reports can be
released, OR determine the plan of action to bring work into compliance, and release work. A
team, with all principals involved (e.g., Laboratory Director, Technical Manager, QA Manager) can
devise a start-up plan to cover all steps from client notification through compliance and release of
reports. Project Management and the Directors of Client Services and Sales and Marketing must
be notified if clients must be notified or if the suspension/restriction affects the laboratory’s ability
to accept work. The QA Manager must approve start-up or elimination of any restrictions after all
corrective action is complete.
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14.0 CORRECTIVE ACTION
14.1 Overview
A major component of the laboratory’s (QA) Program is the problem investigation and feedback
mechanism designed to keep the laboratory staff informed on quality related issues and to provide
insight to problem resolution. When nonconforming work or departures from policies and
procedures in the quality system or technical operations are identified, the corrective action
procedure provides a systematic approach to assess the issues, restore the laboratory’s system
integrity, and prevent reoccurrence. The laboratory employs two systems to manage non-
conformances. Issues suspected of being systematic in nature and for which root cause analysis
and a formal Corrective Action Report (CAR) are documented in the Incident Corrective Action
Tracking (ICAT) database. Routine batch non-conformances, events that are understood to be
isolated in nature, are documented in the LIMS non-conformance memo (NCM) system.
14.2 General
Problems within the quality system or within analytical operations may be discovered in a variety
of ways, such as QC sample failures, internal or external audits, proficiency testing (PT)
performance, client complaints, staff observation, etc.
The purpose of a corrective action system is to:
 Identify non-conformance events and assign responsibility for investigating.
 Resolve non-conformance events and assign responsibility for any required corrective action.
 Identify systematic problems before they become serious.
 Identify and track client complaints and provide resolution.
14.2.1 Non-Conformance Memo (NCM)
NCMs are used to document the following types of corrective actions:
 Deviations from an established procedure or SOP
 QC outside of limits
 Isolated reporting / calculation errors
 Client complaints
 Discrepancies in materials / goods received vs. manufacturer packing slips (Forms of
documentation other than NCMs in LIMS are also acceptable)
14.2.2 Corrective Actions Documented In the ICAT Database
 Internal and external audit findings
 Failed or unacceptable PT results
 Identified poor process or method performance trends
 Systematic reporting / calculation errors
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 Data recall investigations
 Questionable trends that are found in the review of NCMs.
 Client complaints
 Excessive revised reports
The ICAT database is used to document background information, track the results of corrective
action investigations and root cause analysis, and to provide reports of corrective action plans.
14.3 Closed Loop Corrective Action Process
Any employee in the company can initiate a corrective action. There are four main components to
a closed-loop corrective action process once an issue has been identified: Cause Analysis,
Selection and Implementation of Corrective Actions (both short and long term), Monitoring of the
Corrective Actions, and Follow-up.
14.3.1 Cause Analysis
 Upon discovery of a non-conformance event, the event must be defined and documented. An
entry into the ICAT system must be initiated, someone is assigned to investigate the issue
and the event is investigated for cause. Table 14-1 provides some general guidelines on
determining responsibility for assessment.
 The cause analysis step is the key to the process as a long term corrective action cannot be
determined until the cause is determined.
 If the cause is not readily obvious, the Technical Manager, Laboratory Director, or QA
Manager (or QA designee) is consulted.
14.3.2 Selection and Implementation of Corrective Actions
 Where corrective action is needed, the laboratory shall identify potential corrective actions.
The action(s) most likely to eliminate the problem and prevent recurrence are selected and
implemented. Responsibility for implementation is assigned.
 Corrective actions shall be to a degree appropriate to the magnitude of the problem identified
through the cause analysis.
 Whatever corrective action is determined to be appropriate, the laboratory shall document and
implement the changes. The ICAT record is used for this documentation.
14.3.3 Root Cause Analysis
Root Cause Analysis is a class of problem solving (investigative) methods aimed at identifying
the basic or causal factor(s) that underlie variation in performance or the occurrence of a
significant failure. The root cause may be buried under seemingly innocuous events, many steps
preceding the perceived failure. At first glance, the immediate response is typically directed at a
symptom and not the cause. Typically, root cause analysis would be best with three or more
incidents to triangulate a weakness. NDSC Document No. NDSC-QA-SOP43847, Root Cause
Analysis, provides guidance on this procedure.
Systematically analyze and document the root causes of the more significant problems that are
reported. Identify, track, and implement the corrective actions required to reduce the likelihood of
recurrence of significant incidents. Trend the root cause data from these incidents to identify root
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causes that, when corrected, can lead to dramatic improvements in performance by eliminating
entire classes of problems.
Identify the one event associated with problem and ask why this event occurred. Brainstorm the
root causes of failures; for example, by asking why events occurred or conditions existed; and
then why the cause occurred consecutive times until you get to the root cause. For each of these
sub events or causes, ask why it occurred. Repeat the process for the other events associated
with the incident.
Root cause analysis does not mean the investigation is over. Look at technique or other systems
outside the normal indicators. Often creative thinking will find root causes that ordinarily would
be missed and continue to plague the laboratory or operation.
14.3.4 Monitoring of the Corrective Actions
 The Technical Manager and QA Manager are responsible to ensure that the corrective action
taken was effective.
 Ineffective actions are documented and re-evaluated until acceptable resolution is achieved.
Technical Managers are accountable to the Laboratory Director to ensure final acceptable
resolution is achieved and documented appropriately.
 The QA Manager reviews monthly NCM and ICAT records for trends. Highlights are included
in the QA monthly report (refer to Section 18). If a significant trend develops that adversely
affects quality, an audit of the area is performed and corrective action implemented.
 Any out-of-control situations that are not addressed acceptably at the laboratory level may be
reported to the NDSC Quality Director by the QA Manager, indicating the nature of the out-of-
control situation and problems encountered in solving the situation.
14.3.5 Follow-up Audits
 Follow-up audits may be initiated by the QA Manager and shall be performed as soon as
possible when the identification of a nonconformance casts doubt on the laboratory’s
compliance with its own policies and procedures, or on its compliance with state or federal
requirements.
 These audits often follow the implementation of the corrective actions to verify effectiveness.
An additional audit would only be necessary when a critical issue or risk to business is
discovered.
(Also refer to Section 17.1.4, Special Audits.)
14.4 Technical Corrective Actions
In addition to providing acceptance criteria and specific protocols for technical corrective actions
in the method SOPs, the laboratory has general procedures to be followed to determine when
departures from the documented policies and procedures and quality control have occurred (refer
to Section 13). The documentation of these procedures is through the use of an NCM or record
in the ICAT system.
Table 14-1 includes examples of general technical corrective actions. For specific criteria and
corrective actions, refer to the analytical methods or specific method SOPs. The laboratory may
also maintain Work Instructions on these items that are available upon request.
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Table 14-1 provides some general guidelines for identifying the individual(s) responsible for
assessing each QC type and initiating corrective action. The table also provides general guidance
on how a data set should be treated if associated QC measurements are unacceptable. Specific
procedures are included in Method SOPs, Work Instructions, QA Manual Sections 19 and 20. All
corrective actions are reviewed monthly, at a minimum, by the QA Manager and highlights are
included in the QA monthly report.
To the extent possible, samples shall be reported only if all quality control measures are
acceptable. If the deficiency does not impair the usability of the results, data will be reported with an
appropriate data qualifier and/or the deficiency will be noted in the case narrative. Where sample
results may be impaired, the PM is notified by an NCM and appropriate corrective action (e.g.,
reanalysis) is taken and documented.
14.5 Basic Corrections
When mistakes occur in records, each mistake shall be cr ossed-out, [not obliterated (e.g. no
white-out)], and the correct value entered alongside. All such corrections shall be initialed (or
signed) and dated by the person making the correction. In the case of records stored
electronically, the original uncorrected file must be maintained intact and a second corrected file
is created. This same process applies to adding additional information to a record. All additions
made later than the initial must also be initialed (or signed) and dated. When corrections are due
to reasons other than obvious transcription errors, the reason for the corrections (or additions)
shall also be documented.

Table 14-1. Example – General Corrective Action Procedures
QC Activity
(Individual
Responsible for
Initiation/Assessment)

Acceptance Criteria

Recommended
Corrective Action
Initial Instrument Blank

(Analyst)
- Instrument response < MDL. - Prepare another blank.
- If same response, determine cause of
contamination: reagents, environment,
instrument equipment failure, etc.
Initial Calibration
Standards

(Analyst, Technical
Manager(s))
- Correlation coefficient > 0.99 or
standard concentration value.
- % Recovery within acceptance
range.
- See details in Method SOP.
- Reanalyze standards.
- If still unacceptable, remake standards
and recalibrate instrument.
Independent Calibration
Verification
(Second Source)
(Analyst, Technical
Manager(s))
- % Recovery within control
limits.
- Remake and reanalyze standard.
- If still unacceptable, then remake
calibration standards or use new
primary standards and recalibrate
instrument.
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QC Activity
(Individual
Responsible for
Initiation/Assessment)

Acceptance Criteria

Recommended
Corrective Action
Continuing Calibration
Standards
(Analyst, Data Reviewer)
% Recovery within control limits.

- Reanalyze standard.
- If still unacceptable, then recalibrate
and rerun affected samples.
Matrix Spike /
Matrix Spike Duplicate
(MS/MSD)

(Analyst, Data Reviewer)
- % Recovery within limits
documented in the LIMS or
Project QAPP.
- If the acceptance criteria for duplicates
or matrix spikes are not met because of
matrix interferences, the acceptance of
the analytical batch is determined by
the validity of the LCS.
- If the LCS is within acceptable limits
the batch is acceptable.
- The results of the duplicates, matrix
spikes and the LCS are reported with
the data set.
- For matrix spike or duplicate results
outside criteria the data for that sample
shall be reported with qualifiers.
Laboratory Control
Sample (LCS)

(Analyst, Data Reviewer)
- % Recovery within limits
specified in the LIMS or Project
QAPP.
- Batch must be re-prepared and re-
analyzed. This includes any allowable
marginal exceedance.
When not using marginal exceedances,
the following exceptions apply:
1) when the acceptance criteria for the
positive control are exceeded high (i.e.,
high bias) and there are associated
samples that are non-detects, then
those non-detects may be reported with
data qualifying codes;
2) when the acceptance criteria for the
positive control are exceeded low (i.e.,
low bias), those sample results may be
reported if they exceed a maximum
regulatory limit/decision level with data
qualifying codes.
Note: If there is insufficient sample or
the holding time cannot be met, contact
client and report with flags.
Surrogates
(Analyst, Data Reviewer)
- % Recovery within limits of
method or within three standard
deviations of the historical mean.
- Individual sample must be repeated.
Place comment in LIMS.
- Surrogate results outside criteria shall
be reported with qualifiers.
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QC Activity
(Individual
Responsible for
Initiation/Assessment)

Acceptance Criteria

Recommended
Corrective Action
Method Blank (MB)

(Analyst, Data Reviewer)
< Reporting Limit 1

- Reanalyze blank.
- If still positive, determine source of
contamination. If necessary, reprocess
(i.e. digest or extract) entire sample
batch. Report blank results.
- Qualify the result(s) if the
concentration of a targeted analyte in
the MB is at or above the reporting limit
AND is > 1/10 of the amount measured
in the sample.
Proficiency Testing (PT)
Samples
(QA Manager, Technical
Manager(s))
- Criteria supplied by PT
Supplier.
- Any failures or warnings must be
investigated for cause. Failures may
result in the need to repeat a PT sample
to show the problem is corrected.
Internal / External Audits

(QA Manager, Technical
Manager(s), Laboratory
Director)
- Defined in Quality System
documentation such as SOPs,
QAM, etc.
- Non-conformances must be
investigated through CAR system and
necessary corrections must be made.
Reporting / Calculation
Errors
(Depends on issue –
possible individuals
include: Analysts, Data
Reviewers, Project
Managers, Technical
Managers, QA Manager,
NDSC QA, Executive
Management)
- NDSC Document No. QA-
QP38229, Nonconforming Work.
- Corrective action is determined by
type of error. Follow the procedures in
NDSC Document No. QA-QP38228.
Client Complaints

(Project Managers, Lab
Director/Manager, Sales
and Marketing)
- - Corrective action is determined by the
type of complaint. For example, a
complaint regarding an incorrect
address on a report will result in the
report being corrected and then follow-
up must be performed on the reasons
the address was incorrect (e.g.,
database needs to be updated).
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QC Activity
(Individual
Responsible for
Initiation/Assessment)

Acceptance Criteria

Recommended
Corrective Action
QA Monthly Report
(Refer to Section 16 for
an example)
(QA Manager, Lab
Director/Manager,
Technical Manager(s))
- QAM, SOPs. - Corrective action is determined by the
type of issue. For example, CARs for
the month are reviewed and possible
trends are investigated.

Health and Safety
Violation
(Safety Officer, Lab
Director/Manager,
Technical Manager(s))
- Environmental Health and
Safety (EHS) Manual.
- Non-conformance is investigated and
corrected through CAR system.

Note:
1. Except as noted below for certain compounds, the method blank should be below the detection
(reporting) limit. Concentrations up to five times the reporting limit will be allowed for the ubiquitous
laboratory and reagent contaminants as defined in policy WS-PQA-003 provided they appear at similar
levels in the reagent blank and samples. The ubiquitous contaminants include: methylene chloride, toluene,
acetone, 2-butanone, phthalates and octachlorodibenzodioxin. This allowance presumes that the detection
limit is significantly below any regulatory limit to which the data are to be compared and that blank
subtraction will not occur. For benzene and ethylene dibromide (EDB) and other analytes for which
regulatory limits are extremely close to the detection limit, the method blank must be below the method
detection limit.

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15.0 PREVENTIVE ACTION / IMPROVEMENT
15.1 Overview
The laboratory’s preventive action programs improve or eliminate potential causes of
nonconforming product and/or nonconformance to the quality system. This preventive action
process is a proactive and continuous process of improvement activities that can be initiated
through feedback from clients, employees, business providers, and affiliates. The QA Department
has the overall responsibility to ensure that the preventive action process is in place, and that
relevant information on actions is submitted for management review.
Dedicating resources to an effective preventive action system emphasizes the laboratory’s
commitment to its QA Program. It is beneficial to identify and address negative trends before they
develop into complaints, problems and corrective actions. Additionally, the laboratory continually
strives to improve customer service and client satisfaction through continuous improvements to
laboratory systems.
Opportunities for improvement may be discovered through any of the following:
 review of the monthly QA Metrics Report,
 trending NCMs,
 review of control charts and QC results,
 trending proficiency testing (PT) results,
 performance of management system reviews,
 trending client complaints,
 review of processing operations, or
 staff observations.
The monthly Management Systems Metrics Report shows performance indicators in all areas of
the laboratory and quality system. These areas include revised reports, corrective actions, audit
findings, internal auditing and data authenticity audits, client complaints, PT samples, holding time
violations, SOPs, ethics training, etc. The metrics report is reviewed monthly by the laboratory
management, NDSC QA Team, Local and Executive Management. These metrics are used in
evaluating the management and quality system performance on an ongoing basis and provide a
tool for identifying areas for improvement.
Items identified as continuous improvement opportunities to the management system may be
issued as goals from the annual management systems review, recommendations from internal
audits, white papers, Lessons Learned, Technical Services audit report, Technical Best Practices,
or as Executive or management initiatives.
The laboratory’s corrective action process is integral to implementation of preventive actions. A
critical piece of the corrective action process is the implementation of actions to prevent further
occurrence of a non-compliance event. Historical review of corrective action and non-
conformances provides a valuable mechanism for identifying preventive action opportunities.
15.1.1 The following elements are part of a preventive action/process improvement system:
 Identification of an opportunity for preventive action or process improvement.
 Process for the preventive action or improvement.
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 Define the measurements of the effectiveness of the process once undertaken.
 Execution of the preventive action or improvement.
 Evaluation of the plan using the defined measurements.
 Verification of the effectiveness of the preventive action or improvement.
 Close-Out by documenting any permanent changes to the Quality System as a result of the
Preventive Action or Process Improvement. Documentation of Preventive Action/process
Improvement is incorporated into the monthly QA reports, corrective action process and
management review.
15.1.2 Any preventive actions/process improvement undertaken or attempted shall be taken into
account during the annual Management Systems Review (Section 16). A highly detailed report is
not required; however, a summary of successes and failures within the preventive action program
is sufficient to provide management with a measurement for evaluation.
15.2 Management of Change
The Management of Change process is designed to manage significant events and changes that
occur within the laboratory. Through these procedures, the potential risks inherent with a new
event or change are identified and evaluated. The risks are minimized or eliminated through pre-
planning and the development of preventive measures. The types of changes covered under this
system include: Facility Changes, Major Accreditation Changes, Addition or Deletion to Division’s
Capabilities or Instrumentation, Key Personnel Changes, Laboratory Information Management
System (LIMS) changes. This process is discussed in further detail in WS-QA-0050,
Management of Change Procedures.
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16.0 CONTROL OF RECORDS
The laboratory maintains a records management system appropriate to its needs and that
complies with applicable standards or regulations as required. The system produces unequivocal,
accurate records that document all laboratory activities. The laboratory retains all original
observations, calculations and derived data, calibration records and a copy of the analytical report
for a minimum of five years after it has been issued. Exceptions for programs with longer retention
requirements are discussed in Section 16.1.2.
16.1 Overview
The laboratory has established procedures for identification, collection, indexing, access, filing,
storage, maintenance and disposal of quality and technical records. A record index is listed in
Table 16-1. More detailed information on retention of specific records is provided in NDSC
Document Nos. CW -L-P-001, Records Retention Policy and CW-L-WI-001, Records
Retention/Storage Schedule. Quality records are maintained by the QA department in a database
or in specific folders on the local QA share on a corporate server, which is backed up as part of
the regular laboratory backup. Records are of two types; either electronic or hard copy paper
formats depending on whether the record is computer or hand generated (some records may be
in both formats). Technical records are maintained by Department Managers.
Table 16-1. Record Index
Record Types 1: Retention Time:
Technical
Records
- Raw Data
- Logbooks2
- Standards
- Certificates
- Analytical Records
- MDLs/IDLs/DOCs
- Lab Reports
5 Years from analytical report issue*
Official
Documents
- Quality Assurance Manual (QAM)
- Work Instructions
- Policies
- SOPs
- Policy Memorandum s
- Manuals
- Published Methods
Indefinitely
QA Records - Certifications
- Method and Software Validation /
Verification Data
Indefinitely
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Record Types 1: Retention Time:
QA Records - Internal & External Audits/Responses
- Corrective/Preventive Actions
- Management Reviews
- Data Investigation
5 Years from archival*

Data Investigation: 5 years or the life of the
affected raw data storage whichever is
greater (beyond 5 years if ongoing project or
pending investigation)
Project
Records
- Sample Receipt & COC Documents
- Contracts and Amendments
- Correspondence
- QAPP
- SAP
- Telephone Logbooks
- Lab Reports
5 Years from analytical report issue*
Administrative
Records
Financial and Business Operations Refer to NDSC Doc. No. CW-L-WI-001
EH&S Manual, Permits Indefinitely
Disposal Records Indefinitely
Employee Handbook Indefinitely
Personnel files, Employee Signature &
Initials, Administrative Training Records
(e.g., Ethics)
Refer to HR Manual
Administrative Policies Indefinitely
Technical Training Records 7 years
Legal Records Indefinitely
HR Records Refer to NDSC Doc. No. CW-L-WI-001
IT Records Refer to NDSC Doc. No. CW-L-WI-001
NDSC Governance Records Refer to NDSC Doc. No. CW-L-WI-001
Sales & Marketing 5 years
Real Estate Indefinitely

1 Record Types encompass hardcopy and electronic records.
2 Examples of Logbook types: Maintenance, Instrument Run, Preparation (standard and samples),
Standard and Reagent Receipt, Archiving, Balance Calibration, Temperature (hardcopy or electronic
records).
* Exceptions listed in Table 16-2.

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16.1.1 All records are stored and retained in such a way that they are secure and readily
retrievable at the laboratory facility that provides a suitable environment to prevent damage or
deterioration and to prevent loss. All records shall be protected against fire, theft, loss,
environmental deterioration, and vermin. In the case of electronic records, electronic or magnetic
sources, storage media are protected from deterioration caused by magnetic fields and/or
electronic deterioration. Access to the data is limited to laboratory and company employees and
shall be documented with an access log. Logs are maintained in each storage area to note
removal and return of records. Records are maintained for a minimum of five years unless
otherwise specified by a client or regulatory requirement.
For raw data and project records, record retention shall be calculated from the date the project
report is issued. For other records, such as NDSC Documents, QA, or Administrative Records,
the retention time is calculated from the date the record is formally retired. Records related to the
programs listed in Table 16-2 have lengthier retention requirements and are subject to the
requirements in Section 16.1.3.
16.2 Programs with Longer Retention Requirements
Some regulatory programs have longer record retention requirements than the standard record
retention time. These are detailed in Table 16-2 with their retention requirements. In these cases,
the longer retention requirement is enacted. If special instructions exist such that client data
cannot be destroyed prior to notification of the client, the container or box containing that data is
marked as to who to contact for authorization prior to destroying the data.
Table 16-2. Example: Special Record Retention Requirements
Program 1Retention Requirement
Drinking Water – All States 10 years (lab reports and raw data)
10 years - Radiochemistry (project records)
Drinking Water Lead and Copper Rule 12 years (project records)
Commonwealth of MA – All environmental
data 310 CMR 42.14
10 years
FIFRA – 40 CFR Part 160 Retain for life of research or marketing permit for
pesticides regulated by EPA
Housing and Urban Development (HUD)
Environmental Lead Testing
10 years
Alaska 10 years
Louisiana – All 10 years
Michigan Department of Environmental
Quality – all environmental data
10 years
Navy Facilities Engineering Service Center
(NFESC)
10 years
Ohio VAP 10 years and State contacted prior to disposal
OSHA 30 years
1Note: Extended retention requirements must be noted with the archive documents or addressed in facility-
specific records retention procedures.

16.2.1 The laboratory has procedures to protect and back-up records stored electronically and to
prevent unauthorized access to or amendment of these records. All analytical data is maintained
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as hard copy or in a secure readable electronic format. For analytical reports that are maintained
as copies in PDF format, refer to Section 19.15.1 and WS-PQA-017 for more information.
16.2.2 The record keeping system allows for historical reconstruction of all laboratory activities
that produced the analytical data, as well as rapid recovery of historical data. The history of the
sample from when the laboratory took possession of the samples must be readily understood
through the documentation. This shall include inter-laboratory transfers of samples and/or
extracts.
 The records include the identity of personnel involved in sampling, sample receipt,
preparation, or testing. All analytical work contains the initials (at least) of the personnel
involved. The laboratory’s copy of the COC is stored with the invoice and the work order
sheet generated by the LIMS as scanned documents within the LIMS. The chain of custody
would indicate the name of the sampler. If any sampling notes are provided with a work
order, they are kept with this package.
 All information relating to the laboratory facilities equipment, analytical test methods, and
related laboratory activities, such as sample receipt, sample preparation, or data verification
are documented.
 The record keeping system facilitates the retrieval of all working files and archived records
for inspection and verification purposes (e.g., set format for naming electronic files, set format
for what is included with a given analytical data set.) Refer to SOP WS-QA-0009, Document
Archiving. Instrument data is stored sequentially by instrument. A given day’s analyses are
maintained in the order of the analysis. Run logs are maintained for each instrument or
method; a copy of each day’s run log or instrument sequence is stored with the data to aid in
re-constructing an analytical sequence. Where an analysis is performed without an
instrument, bound logbooks or bench sheets are used to record and file data. Standard and
reagent information is recorded in logbooks or entered into LIMS for each method as
required.
 Changes to hardcopy records shall follow the procedures outlined in Section 12 and 19.
Changes to electronic records in LIMS or instrument data are recorded in audit trails.
 The reason for a signature or initials on a document is clearly indicated in the records such
as “sampled by,” “prepared by,” “reviewed by”, or “analyzed by”.
 All generated data except those that are generated by automated data collection systems,
are recorded directly, promptly and legibly in permanent dark ink.
 Hard copy data may be scanned into PDF format for record storage as long as the scanning
process can be verified in order to ensure that no data is lost and the data files and storage
media must be tested to verify the laboratory’s ability to retrieve the information prior to the
destruction of the hard copy that was scanned. The procedure for this verification can be
found in SOP WS-QA-0009.
 Also refer to Section 19.15.1 ‘Computer and Electronic Data Related Requirements’.
16.3 Technical and Analytical Records
16.3.1 The laboratory retains records of original observations, derived data and sufficient
information to establish an audit trail, calibration records, staff records and a copy of eac h
analytical report issued, for a minimum of five years unless otherwise specified by a client or
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regulatory requirement. The records for each analysis shall contain sufficient information to
enable the analysis to be repeated under conditions as close as possible to the original. The
records shall include the identity of laboratory personnel responsible for the sampling,
performance of each analysis and reviewing results.
16.3.2 Observations, data and calculations are recorded real-time and are identifiable to the
specific task.
16.3.3 Changes to hardcopy records shall follow the procedures outlined in Section 12 and 19.
Changes to electronic records in LIMS or instrument data are recorded in audit trails.
The essential information to be associated with analysis, such as strip charts, tabular printouts,
computer data files, analytical notebooks, and run logs, include:
 Laboratory sample ID code;
 Date of analysis; time of analysis is also required if the holding time is seventy-two (72) hours
or less, or when time critical steps are included in the analysis (e.g., drying times, incubations,
etc.); instrumental analyses have the date and time of analysis recorded as part of their
general operations. Where a time critical step exists in an analysis, location for such a time
is included as part of the documentation in a specific logbook or on a benchsheet.
 Instrumentation identification and instrument operating conditions/parameters. Operating
conditions/parameters are typically recorded in instrument maintenance logs where
available.
 analysis type;
 all manual calculations and manual integrations;
 analyst's or operator's initials/signature;
 sample preparation including cleanup, separation protocols, ID codes, volumes, weights,
instrument printouts, meter readings, calculations, reagents;
 test results;
 standard and reagent origin, receipt, preparation, and use;
 calibration criteria, frequency and acceptance criteria;
 data and statistical calculations, review, confirmation, interpretation, assessment and
reporting conventions;
 quality control protocols and assessment;
 electronic data security, software documentation and verif ication, software and hardware
audits, backups, and records of any changes to automated data entries; and
 Method performance criteria including expected quality control requirements. These are
indicated both in LIMS and on specific analytical report formats.
16.3.4 All logbooks used during receipt, preparation, storage, analysis, and reporting of samples
or monitoring of support equipment shall undergo a periodic, documented supervisory or peer
review.
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16.4 Laboratory Support Activities
In addition to documenting all the above-mentioned activities, the following are retained QA
records and project records (previous discussions in this section relate where and how these data
are stored):
 all original raw data, whether hard copy or electronic, for calibrations, samples and quality
control measures, including analysts’ work sheets and data output records (chromatograms,
strip charts, and other instrument response readout records);
 a written description or reference to the specific test method used which includes a
description of the specific computational steps used to translate parametric observations into
a reportable analytical value;
 copies of final reports;
 archived SOPs;
 correspondence relating to laboratory activities for a specific project;
 all corrective action reports, audits and audit responses;
 proficiency test results and raw data; and
 results of data review, verification, and crosschecking procedures
16.4.1 Sample Handling Records
Records of all procedures to which a sample is subjected while in the possession of the laboratory
are maintained. These include but are not limited to records pertaining to:
 sample preservation including appropriateness of sample container and compliance with
holding time requirement;
 sample identification, receipt, acceptance or rejection and login;
 sample storage and tracking including shipping receipts, sample transmittal / COC forms;
and
 procedures for the receipt and retention of samples, including all provisions necessary to
protect the integrity of samples.
16.5 Administrative Records
The laboratory also maintains the administrative records in either electronic or hard copy form.
Refer to Table 16-1.
16.6 Records Management, Storage and Disposal
All records (including those pertaining to test equipment), certif icates and reports are safely
stored, held secure and in confidence to the client. Certification related records are available upon
request.
All information necessary for the historical reconstruction of data is maintained by the laboratory.
Records that are stored only on electronic media must be supported by the hardware and software
necessary for their retrieval.
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Records that are stored or generated by computers or personal computers have hard copy, write-
protected backup copies, or an electronic audit trail controlling access.
The laboratory has a record management system (a.k.a., document control) for control of
laboratory notebooks, instrument logbooks, standards logbooks, and records for data reduction,
validation, storage and reporting. Laboratory notebooks are issued on a per analysis basis, and
are numbered sequentially. All data are recorded sequentially within a series of sequential
notebooks. Bench sheets are filed sequentially. Standards are maintained in LIMS. Records are
considered archived when noted as such in the records management system (a.k.a., document
control.)
16.6.1 Transfer of Ownership
In the event that the laboratory transfers ownership or goes out of business, the laboratory shall
ensure that the records are maintained or transferred according to client’s instructions. Upon
ownership transfer, record retention requirements shall be addressed in the ownership transfer
agreement and the responsibility for maintaining archives is clearly established. In addition, in
cases of bankruptcy, appropriate regulatory and state legal requirements concerning laboratory
records must be followed. In the event of the closure of the laboratory, all records will revert to
the control of the NDSC. Should the entire company cease to exist, as much notice as possible
will be given to clients and the accrediting bodies who have worked with the laboratory during the
previous 5 years of such action.
16.6.2 Records Disposal
Records are removed from the archive and destroyed after 5 years unless otherwise specified by
a client or regulatory requirement. On a project specific or program basis, clients may need to be
notified prior to record destruction. Records are destroyed in a manner that ensures their
confidentiality such as shredding, mutilation or incineration. (Refer to Tables 16-1 and 16-2).
Electronic copies of records must be destroyed by erasure or physically damaging off-line storage
media so no records can be read.
If a third party records management company is hired to dispose of records , a “Certificate of
Destruction” is required.
Records maintained within LIMS are purged from the system based on the retention period/type
associated to the project. The LIMS administrator queries the database on a quarterly basis and
provides a listing of the records to be purged to the client services organization (CSO). The CSO
reviews the list and adjusts any incorrect retention settings. Then the LIMS Administrator starts
an automated process that removes the data identified as ready for purging.
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17.0 AUDITS
17.1 Internal Audits
Internal audits are performed to verify that laboratory operations comply with the requirements of
the lab’s quality system and with the external quality programs under which the laboratory
operates. Audits are planned and organized by the QA staff. Personnel conducting the audits
should be independent of the area being evaluated. Auditors will have sufficient authority, access
to work areas, and organizational freedom necessary to observe all activities affecting quality and
to report the assessments to laboratory management and, when requested, to Executive
management.
Audits are conducted and documented as described in the NDSC Document on performing
Internal Auditing, SOP No. SOP02-QA-QP5260. The types and frequency of routine internal
audits are described in Table 17-1. Special or ad hoc assessments may be conducted as needed
under the direction of the QA staff.
Table 17-1. Types of Internal Audits and Frequency
Description Performed by Frequency
Quality Systems Audits QA Department, QA
approved designee, or
NDSC QA
All areas of the laboratory annually
QA Technical Audits Joint responsibility:
a) QA Manager or
designee
b) Technical Manager or
Designee
(Refer to NDSC SOP02-
QA-QP5260)

Technical Audits Frequency:
50% of methods annually

SOP Method Compliance Joint responsibility:
a) QA Manager or
designee
c) Technical Manager or
Designee
(Refer to NDSC SOP02-
QA-QP5260)
SOP Compliance Review Frequency
 Minimum of every two years.
 Annually for all methods and
administrative SOPs relating to
DoD/DOE programs.
 Annually for drinking water methods.
Special QA Department or
Designee
Surveillance or spot checks performed as
needed, e.g., to confirm corrective actions
from other audits.
Performance Testing Analysts with QA oversight Two successful per year for each TNI field
of testing or as dictated by regulatory
requirements

17.1.1 Annual Quality Systems Audit
An annual quality systems audit is required to ensure compliance to analytical methods and
SOPs, Eurofins Data Integrity and Ethics Policies (see Section 7.2), TNI quality systems, client
and state requirements, and the effectiveness of the internal controls of the analytical process,
including but not limited to data review, quality controls, preventive action and corrective action.
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The completeness of earlier corrective actions is assessed for effectiveness & sustainability. The
audit is divided into sections for each operating or support area of the lab, and each section is
comprehensive for a given area. The area audits may be performed on a rotating schedule
throughout the year to ensure adequate coverage of all areas. This schedule may change as
situations in the laboratory warrant.
17.1.2 QA Technical Audits
QA technical audits assess data authenticity and analyst integrity. These audits are based on
client projects, associated sample delivery groups, and the methods performed. Reported results
are compared to raw data to verify the authenticity of results. The validity of calibrations and QC
results are compared to data qualifiers, footnotes, and case narratives. Documentation is
assessed by examining run logs and records of manual integrations. Manual calculations are
checked. Where possible, electronic audit miner programs (e.g., Chrom AuditMiner) are used to
identify unusual manipulations of the data deserving closer scrutiny. QA technical audits will
include all methods within a two-year period.
17.1.3 SOP Method Compliance
Compliance of all SOPs with the source methods and compliance of the operational groups with
the SOPs will be assessed by the Technical Manager or qualified designee at least every two
years. This is performed annually for methods and administrative SOPs related to drinking water
and DoD/DOE programs. It is also recommended that the work of each newly hired analyst is
assessed within 3 months of working independently, (e.g., completion of method IDOC). In
addition, as analysts add methods to their capabilities, (new IDOC) reviews of the analyst work
products will be performed within 3 months of completing the documented training.
17.1.4 Special Audits
Special audits are conducted on an as needed basis, generally as a follow up to specific issues
such as client complaints, corrective actions, PT results, data audits, system audits, validation
comments, regulatory audits or suspected ethical improprieties. Special audits are focused on a
specific issue, and report format, distribution, and timeframes are designed to address the nature
of the issue.
17.1.5 Performance Testing
The laboratory participates semi-annually in performance audits conducted through the analysis
of PT samples provided by a third party. The laboratory generally participates in the following
types of PT studies: Soil, Water Supply, Water Pollution, and round-robin studies for sediments
and biological materials. When available for parameters tested by the laboratory, the laboratory
will also participate in the DOE administered MAPEP program.
It is Eurofins policy that PT samples be treated as typical samples in the production process.
Furthermore, where PT samples present special or unique problems, in the regular production
process they may need to be treated differently, as would any special or unique request submitted
by any client. The QA Manager must be consulted and in agreement with any decisions made to
treat a PT sample differently due to some special circumstance.
Written investigations for unacceptable PT results are required. In some cases it may be
necessary for blind QC samples to be submitted to the laboratory to show a return to control.
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17.2 External Audits
External audits are performed when certifying agencies or clients conduct on-site inspections or
submit performance testing samples for analysis. It is Eurofins policy to cooperate fully with
regulatory authorities and clients. The laboratory makes every effort to provide the auditors with
access to personnel, documentation, and assistance. Laboratory supervisors are responsible for
providing corrective actions to the QA Manager who coordinates the response. Audit responses
are due in the time allotted by the client or agency performing the audit.
The laboratory cooperates with clients and their representatives to monitor the laboratory’s
performance in relation to work performed for the client. The client may only view data and
systems related directly to the client’s work. All efforts are made to keep other client information
confidential.
17.2.1 Confidential Business Information (CBI) Considerations
During on-site audits, auditors may come into possession of information claimed as business
confidential. A business confidentiality claim is defined as “a claim or allegation that business
information is entitled to confidential treatment for reasons of business confidentiality or a request
for a determination that such information is entitled to such treatment.” When information is
claimed as business confidential, the laboratory must place on (or attach to) the information at
the time it is submitted to the auditor, a cover sheet, stamped or typed legend or other suitable
form of notice, employing language such as “trade secret”, “proprietary” or “company confidential”.
Confidential portions of documents otherwise non-confidential must be clearly identified. CBI may
be purged of references to client identity by the responsible laboratory official at the time of
removal from the laboratory. However, sample identifiers may not be obscured from the
information. Additional information regarding CBI can be found within the 2009 and 2016 TNI
standards
17.3 Audit Findings
Audit findings are documented using the corrective action process and database (see Section
14). The laboratory’s corrective action responses may include action plans that could not be
completed within a predefined timeframe. In these instances, a completion date must be set and
agreed to by operations management and the QA Manager.
Developing and implementing corrective actions to findings is the responsibility of the Technical
Manager where the finding originated. Findings that are not corrected by specified due dates are
reported monthly to management in the QA monthly report.
If any audit finding casts doubt on the effectiveness of the operations or on the correctness or
validity of the laboratory’s test results, the laboratory shall take timely corrective action, and shall
notify clients in writing if the investigations show that the laboratory results have been affected.
Once corrective action is implemented, a follow-up audit is scheduled to ensure that the problem
has been corrected.
Clients must be notified promptly in writing, of any event such as the identification of defective
measuring or test equipment that casts doubt on the validity of results given in any test report or
amendment to a test report. The investigation must begin within 24-hours of discovery of the
problem and all efforts are made to notify the client within two weeks after the completion of the
investigation.
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18.0 MANAGEMENT REVIEWS
18.1 Quality Assurance Report
The QA Department is responsible for preparing a comprehensive monthly metrics report to
Management to keep them apprised of current quality issues. This report fosters communication,
review, and refinement of the QA system to evaluate the suitability of policies and procedures to
meet both regulatory and laboratory quality objectives.
The NDSC QA team compiles information from all of the Environment Testing laboratories
monthly metrics reports for the Executive Management team. This report includes notable
information and concerns regarding the laboratories QA program and a listing of new regulations
that may potentially impact the laboratories.
18.2 Annual Management Review
The Laboratory Management team (Laboratory Director, Technical Managers, and QA Manager)
conducts a review annually of its quality systems to ensure its continuing suitability and
effectiveness in meeting client and regulatory requirements and to introduce any necessary
changes or improvements. It will also provide a platform for defining goals, objectives and action
items that feed into the laboratory planning system. NDSC personnel can be included in this
meeting at the discretion of the Laboratory Director. The LIMS review consists of examining any
audits, complaints or concerns that have been raised through the year that are related to LIMS.
The laboratory will summarize any critical findings that cannot be solved by the lab and report
them to Corporate IT.
This management systems review (NDSC Document No. QA-QP38702 & Form No. NDSC-QA-
FRM43453) uses information generated during the preceding year to assess the “big picture” by
ensuring that routine actions taken and reviewed on a monthly basis are not components of larger
systematic concerns. The monthly review should keep the quality systems current and effective;
therefore, the annual review is a formal senior management process to review specific existing
documentation. Significant issues from the following documentation are compiled or summarized
by the QA Manager prior to the review meeting:
 Matters arising from the previous annual review.
 Prior Monthly QA Reports issues.
 Laboratory QA Metrics.
 Review of report reissue requests.
 Review of client feedback and complaints.
 Issues arising from any prior management or staff meetings.
 Minutes from prior senior lab management meetings. Issues that may be raised from these
meetings include:
o Adequacy of staff, equipment and facility resources.
o Adequacy of policies and procedures.
o Future plans for resources and testing capability and capacity.
 The annual internal double blind PT program sample performance (if performed),
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 Compliance to the Ethics Policy and Data Integrity Plan. Including any evidence/incidents of
inappropriate actions or vulnerabilities related to data Integrity.
 Evaluation of overall risk, including risks to impartiality, confidentiality, reporting statements
of conformity, and nonconforming work.
A report is generated by the QA Manager and management. The report is distributed to the
Laboratory Manager, President of the Business Unit, and the Business Unit Manager. The report
includes, but is not limited to:
 The date of the review and the names and titles of participants.
 A reference to the existing data quality related documents and topics that were reviewed.
 Quality system or operational changes or improvements that will be made as a result of the
review [e.g., an implementation schedule including assigned responsibilities for the changes
(Action Table)].
Changes to the quality systems requiring update to the laboratory QA Manual shall be included
in the next revision of the QA Manual.
18.3 Potential Integrity Related Managerial Reviews
Potential integrity issues (data or business related) must be handled and reviewed in a
confidential manner until such time as a follow-up evaluation, full investigation, or other
appropriate actions have been completed and issues clarified. The NDSC Document No. QA-
QP38228, Internal Investigations, shall be followed. All investigations that result in finding of
inappropriate activity are documented and include any disciplinary actions involved, corrective
actions taken, and all appropriate notifications of clients.
The Eurofins Environment Testing Presidents, Business Unit Managers, Laboratory Directors and
NDSC Team are informed of any current data integrity or data recall investigations via the monthly
metrics report.
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19.0 TEST METHODS AND METHOD VALIDATION
19.1 Overview
The laboratory uses methods that are appropriate to meet our clients’ requirements and that are
within the scope of the laboratory’s capabilities. These include sampling, handling, transport,
storage and preparation of samples, and, where appropriate, an estimation of the measurement
of uncertainty as well as statistical techniques for analysis of environmental data.
Instructions are available in the laboratory for the operation of equipment as well as for the handling
and preparation of samples. All instructions, Standard Operating Procedures (SOPs), reference
methods and manuals relevant to the working of the laboratory are readily available to all staff.
Deviations from published methods are documented (with justification) in the laboratory’s approved
SOPs. SOPs are submitted to clients for review at their request. Significant deviations from
published methods require client approval and regulatory approval where applicable.
19.2 Standard Operating Procedures (SOPs)
The laboratory maintains SOPs that accurately reflect all phases of the laboratory such as
assessing data integrity, corrective actions, handling customer complaints as well as all analytical
methods and sampling procedures. The method SOPs are derived from the most recently
promulgated/approved, published methods and are specifically adapted to the laboratory facility.
Modifications or clarifications to published methods are clearly noted in the SOPs. All SOPs are
controlled in the laboratory.
 All SOPs contain a revision number, effective date, and appropriate approval signatures.
Controlled copies are available to all staff.
 Procedures for writing an SOP are incorporated by reference to the laboratory’s SOP WS-
QA-0021 (Preparation and Management of Standard Operating Procedures).
 SOPs are reviewed at a minimum of every 2 years (annually for Drinking Water and
DoD/DOE SOPs), and where necessary, revised to ensure continuing suitability and
compliance with applicable requirements.
19.3 Laboratory Methods Manual
For each test method, the laboratory shall have available the published referenced method as
well as the laboratory developed SOP.
Note: If more stringent standards or requirements are included in a mandated test method
or regulation than those specified in this manual, the laboratory shall demonstrate that such
requirements are met. If it is not clear which requirements are more stringent, the standard from
the method or regulation is to be followed. Any exceptions or deviations from the referenced
methods or regulations are noted in the specific analytical SOP.
The laboratory maintains an SOP Index for both technical and non-technical SOPs. Technical
SOPs are maintained to describe a specific test method. Non-technical SOPs are maintained to
describe functions and processes not related to a specific test method.
19.4 Selection of Methods
Since numerous methods and analytical techniques are available, continued communication
between the client and laboratory is imperative to assure the correct methods are utilized. Once
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client methodology requirements are established, this and other pertinent information is
summarized by the PM. These mechanisms ensure that the proper analytical methods are
applied when the samples arrive for log-in. For non-routine analytical services (e.g., special
matrices, non-routine compound lists), the method of choice is selected based on client needs
and available technology. The methods selected should be capable of measuring the specific
parameter of interest, in the concentration range of interest, and with the required precision and
accuracy.
19.4.1 Sources of Methods
Routine analytical services are performed using standard EPA-approved methodology. In some
cases, modification of standard approved methods may be necessary to provide accurate
analyses of particularly complex matrices. When the use of specific methods for sample analysis
is mandated through project or regulatory requirements, only those methods shall be used.
When clients do not specify the method to be used or methods are not required, the methods
used will be clearly validated and documented in an SOP and available to clients and/or the end
user of the data. Refer to Appendix 6 for a list of the currently accepted U.S. EPA Analytical
method references used by the laboratory.
The laboratory reviews updated versions to all the aforementioned references for adaptation
based upon capabilities, instrumentation, etc., and implements them as appropriate. As such,
the laboratory strives to perform only the latest versions of each approved method as regulations
allow or require.
Other reference procedures for non-routine analyses may include methods established by specific
states (e.g., Underground Storage Tank methods), ASTM or equipment manufacturers. Sample
type, source, and the governing regulatory agency requiring the analysis will determine the
method utilized.
The laboratory shall inform the client when a method proposed by the client may be inappropriate
or out of date. After the client has been informed, and they wish to proceed contrary to the
laboratory’s recommendation, it will be documented.
19.4.1.1 Client Supplied Methods
Most of the client-supplied method requirements presented to the laboratory involve achieving
specific quality control criteria, limits of quantitation (LOQ), and/or method detection limits (MDL)
using standard EPA methods. These requirements are communicated to the appropriate
technical groups prior to the project start up. Each technical group evaluates the scope of work
and the requirements to ensure the criteria can be met using the standard EPA method. The data
is monitored to ensure the criteria are met throughout the project. The PM notifies the client if
there is a more appropriate method available or if the client’s criteria cannot be achieved on a
certain sample matrix (i.e., due to matrix or dilutions).
Occasionally, the laboratory is asked to transfer a non-standardized method from a client into the
lab or to develop a new method, when one is not available. In the case of a method transfer, the
laboratory will set up the client’s method and perform some initial evaluation. Following the initial
evaluation, the laboratory may make recommendations regarding method performance
improvements. If the method appears to be adequate, we determine linearity, specificity,
precision, accuracy, MDL, and LOQ by performing calibrations, analyzing method blanks, and
carrying out method detection limit and IDOC studies.
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In the case of method development, the laboratory works with the client and/or data user to
determine the level of validation required ensuring that the method meets its intended purpose.
In addition to the elements above, the laboratory may also determine standard and sample
stability and robustness depending on the scope of the project. A standard operating procedure
is written and submitted to the client with the results of the validation. These steps are completed
prior to analysis of field samples. Data related to the setup of the method are archived.
19.4.2 Demonstration of Capability
Before the laboratory may institute a new method and begin reporting results, the laboratory shall
confirm that it can properly operate the method. In general, this demonstration does not test the
performance of the method in real world samples, but in an applicable and available clean matrix
sample. If the method is for the testing of analytes that are not conducive to spiking,
demonstration of capability may be performed on quality control samples.
A demonstration of capability (DOC, Lab SOP # WS-QA-0022) is performed whenever there is a
change in instrument type (e.g., new instrumentation), matrix, method or personnel (e.g., analyst
has not performed the test within the last 12 months).
Note: The laboratory shall have a DOC for all analytes included in the methods that the
laboratory performs, and proficiency DOCs for each analyst shall include all analytes that the
laboratory routinely performs. Addition of non-routine analytes does not require new DOCs for all
analysts if those analysts are already qualified for routine analytes tested using identical chemistry
and instrument conditions.
The initial demonstration of capability must be thoroughly documented and approved by the
Technical Manager and QA Manager prior to independently analyzing client samples. All
associated documentation must be retained in accordance with the laboratory’s archiving
procedures.
The laboratory must have an approved SOP, demonstrate satisfactory performance, and conduct
an MDL study (when applicable). There may be other requirements as stated within the published
method or regulations (e.g., retention time window study).
Note: In some instances, a situation may arise where a client requests that an unusual
analyte be reported using a method where this analyte is not normally reported. If the analyte is
being reported for regulatory purposes, the method must meet all procedures outlined within this
QA Manual (SOP, MDL, and Demonstration of Capability). If the client states that the information
is not for regulatory purposes, the result may be reported as long as the following criteria are met:
 The instrument is calibrated for the analyte to be reported using the criteria for the method
and ICV/CCV criteria are met (unless an ICV/CCV is not required by the method or criteria
are per project DQOs).
 The laboratory’s nominal or default reporting limit (RL) is equal to the quantitation limit (QL),
must be at or above the lowest non-zero standard in the calibration curve and must be reliably
determined. Project RLs are client specified reporting levels which may be higher than the
QL. Results reported below the QL must be qualified as estimated values. Also see Section
19.6.1.3, Relationship of Limit of Detection (LOD) to Quantitation Limit (QL).
 The client request is documented and the lab informs the client of its procedure for working
with unusual compounds. The final report must be footnoted: Reporting Limit based on the
low standard of the calibration curve.
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19.4.3 Initial Demonstration of Capability (IDOC) Procedures
19.4.3.1 The spiking standard used must be prepared independently from those used in
instrument calibration.
19.4.3.2 The analyte(s) shall be diluted in a volume of clean matrix sufficient to prepare f our
aliquots at the concentration specified by a method or the laboratory SOP. If the concentration is
unspecified, the routine LCS spike level may be used.
19.4.3.3 At least four aliquots shall be prepared (including any applicable clean-up procedures)
and analyzed according to the test method (either concurrently or over a period of days).
19.4.3.4 Using all of the results, calculate the mean recovery in the appropriate reporting units
and the standard deviations for each parameter of interest.
19.4.3.5 When it is not possible to determine the mean and standard deviations, such as for
presence, absence and logarithmic values, the laboratory will assess performance against criteria
described in the Method SOP.
19.4.3.6 Compare the information obtained above to the corresponding acceptance criteria for
precision and accuracy in the test method (if applicable) or in laboratory generated acceptance
criteria (LCS or interim criteria) if there is no mandatory criteria established. If any one of the
parameters do not meet the acceptance criteria, the performance is unacceptable for that
parameter.
19.4.3.7 When one or more of the tested parameters fail at least one of the acceptance criteria,
the analyst must proceed according to either option listed below:
 Locate and correct the source of the problem and repeat the test for all parameters of interest
beginning with 19.4.3.3 above.
 Beginning with 19.4.3.3 above, repeat the test for all parameters that failed to meet criteria.
Repeated failure, however, will confirm a general problem with the measurement system. If
this occurs, locate and correct the source of the problem and repeat the test for all
compounds of interest beginning with 19.4.3.1 above.
Note: Results of successive LCS analyses can be used to fulfill the DOC requirement.
Methods on line prior to the effective date of this Section shall be updated to the procedures
outlined above as new analysts perform their demonstration of capability. A copy of the new
record will replace that which was used for documentation in the past. At a minimum, the precision
and accuracy of four mid-level laboratory control samples must have been compared to the
laboratory’s quality control acceptance limits.
In accordance with Arizona Administrative Code R9-14-616.5f, documentation of each analyst’s
performance of proficiency testing, as applicable, will be maintained in the training record.
19.5 Laboratory Developed Methods and Non-Standard Methods
Any new method developed by the laboratory must be fully defined in an SOP and validated by
qualified personnel with adequate resources to perform the method. Method specif ications and
the relation to client requirements must be clearly conveyed to the client if the method is a non-
standard method (not a published or routinely accepted method). The client must also be in
agreement to the use of the non-standard method.
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19.6 Validation of Methods
Validation is the confirmation by examination and the provision of objective evidence that the
particular requirements for a specific intended use are fulfilled.
All non-standard methods, laboratory designed/developed methods, standard methods used
outside of their scope, and major modifications to published methods must be validated to confirm
they are fit for their intended use. The validation will be as extensive as necessary to meet the
needs of the given application. The results are documented with the validation procedure used
and contain a statement as to the fitness for use.
19.6.1 Method Validation and Verification Activities for All New Methods
While method validation can take various courses, the following activities can be required as part
of method validation. Method validation records are designated QC records and are archived
accordingly.
When changes are made to any validated methods, the influence of such changes shall be
documented and, if appropriate, a new validation shall be performed.
19.6.1.1 Determination of Method Selectivity – Method selectivity is the demonstrated ability
to discriminate the analyte(s) of interest from other compounds in the specific matrix or matrices
from other analytes or interference. In some cases to achieve the required selectivity for an
analyte, a confirmation analysis is required as part of the method.
19.6.1.2 Determination of Method Sensitivity – Sensitivity can be both estimated and
demonstrated. Whether a study is required to estimate sensitivity depends on the level of method
development required when applying a particular measurement system to a specific set of
samples. Detection limit studies are conducted as described in Section 19.7. Where other
protocols for estimations and/or demonstrations of sensitivity are required by regulation or client
agreement, these shall be followed.
19.6.1.3 Relationship of Limit of Detection (LOD) to the Limit of Quantitation (LOQ) – An
important characteristic of expression of sensitivity is the distinction between the LOD and the
LOQ. The LOD is the minimum level at which the presence of an analyte can be reliably
concluded. The LOQ is the minimum concentration of analyte that can be quantitatively
determined with acceptable precision and bias, equivalent to the laboratory’s routine reporting
limit (RL). For most instrumental measurement systems, there is a region where semi-quantitative
data is generated around the LOD (both above and below the estimated MDL or LOD) and below
the LOQ. In this region, detection of an analyte may be confirmed but quantif ication of the analyte
is unreliable within the accuracy and precision guidelines of the measurement system. When an
analyte is detected below the LOQ, and the presence of the analyte is confirmed by meeting the
qualitative identification criteria for the analyte, the analyte can be reliably reported, but the
amount of the analyte can only be estimated. If data is to be reported in this region, it must be
done so with a qualification that denotes the semi-quantitative nature of the result.
19.6.1.4 Determination of Interferences – A determination that the method is free from
interferences in a blank matrix is performed.
19.6.1.5 Determination of Range – Where appropriate to the method, the quantitation range
is determined by comparison of the response of an analyte in a curve to established or targeted
criteria. Generally the upper quantitation limit is defined by highest acceptable calibration
concentration. The lower quantitation limit or QL cannot be lower than the lowest non-zero
calibration level, and can be constrained by required levels of bias and precision.
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19.6.1.6 Determination of Accuracy and Precision – Accuracy and precision studies are
generally performed using replicate analyses, with a resulting percent recovery and measure of
reproducibility (standard deviation, relative standard deviation) calculated and measured against
a set of target criteria.
19.6.1.7 Documentation of Method – The method is formally documented in an SOP. If the
method is a minor modification of a standard laboratory method that is already documented in an
SOP, an SOP Attachment describing the specific differences in the new method is acceptable in
place of a separate SOP.
19.6.1.8 Continued Demonstration of Method Performance – Continued demonstration of
method performance is addressed in the SOP. Continued demonstration of method performance
is generally accomplished by batch specific QC samples such as LCS, method blanks or PT
samples.
19.7 Method Detection Limit (MDL) / Limits of Detection (LOD)
The MDL is the minimum measured quantity of a substance that can be reported with 99%
confidence that the concentration is distinguishable from method blank results, consistent with
40CFR Part 136 Appendix B, August, 2017. The MDL is equivalent to the TNI LOD or DL, and is
also equivalent to the DoD/DOE Quality Systems Manual (QSM) DL. The working or final MDL is
the higher of the MDL value determined from spikes (MDLs) and the MDL value determined from
blanks (MDLb). An initial MDL study shall be performed during the method validation process and
when the method is altered in a way that can reasonably be expected to change its sensitivity. On-
going data are collected during each quarter in which samples are being analyzed. At least once
every 13 months the MDLs and MDLb are re-calculated and re-evaluated using data collected
during the preceding period. Details of the procedure for conducting MDL studies are given in NDSC
Document No. NDSC-QA-SOP42091 and laboratory SOP WS-QA-0006.
19.8 Verification of Detection Limits
If it is found during the re-evaluation of detection limit results that more than 5% of the spiked
samples do not return positive numeric results that meet all method qualitative identification
criteria, then then spiking level shall be increased and the initial MDL study re-performed at the
new spiking concentration. Additional requirements for DOD/DOE accredited parameters are
given NDSC Document No. NDSC-QA-SOP42091 - Attachment 2.
19.9 Instrument Detection Limits (IDL)
The IDL is sometimes used to assess the reasonableness of the MDL or in some cases required
by the analytical method or program requirements. IDLs are most commonly used in metals
analyses but may be useful in demonstration of instrument performance in other areas.
IDLs are calculated to determine an instrument’s sensitivity independent of any preparation
method. IDLs are calculated either using 7 replicate spike analyses, like MDL but without sample
preparation, or by the analysis of 10 instrument blanks and calculating 3 x the absolute value of
the standard deviation.
19.10 Limit of Quantitation
The LOQ shall be at a concentration equivalent to the lowest calibration standard concentration,
with the exception of methods using a single-point calibration, and shall be greater than the MDL.
The LOQ is verified by preparing and analyzing spikes at concentrations 1-2X the selected LOQ,
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employing the complete analytical process. Additional requirements for DOD/DOE accredited
parameters are given in NDSC Document No. NDSC-QA-SOP42091.
When the laboratory establishes a quantitation limit, it must be initially verified by the analysis of
a low level standard or QC sample at 1-2 times the reporting limit or by a DL check sample at or
below the LOQ. The LOQ is verified annually thereafter. The annual requirement is waived for
methods that have an annually verified MDL. The laboratory will comply with any regulatory
requirements.
19.11 Retention Time Windows
Most organic analyses and some inorganic analyses use chromatography techniques for qualitative
and quantitative determinations. For every chromatography analysis or as specified in the reference
method, each analyte will have a specific time of elution from the column to the detector. This is
known as the analyte’s retention time. The variance in the expected time of elution is defined as
the retention time window. As the key to analyte identification in chromatography, retention time
windows must be established on every column for every analyte used for that method. These
records are kept on-file and available for review. Complete details are available in the laboratory
SOPs.
19.12 Evaluation of Selectivity
The laboratory evaluates selectivity by following the checks within the applicable analytical
methods, which include mass spectral tuning, second column confirmation, ICP interelement
interference checks, chromatography retention time windows, sample blanks, spectrochemical,
atomic absorption or fluorescence profiles, co-precipitation evaluations and specific electrode
response factors.
19.13 Estimation of Uncertainty of Measurement
19.13.1 Uncertainty is “a parameter associated with the result of a measurement, that
characterizes the dispersion of the values that could reasonably be attributed to the measurand”
(as defined by the International Vocabulary of Basic and General Terms in Metrology, ISO
Geneva, 1993, ISBN 92-67-10175-1). Knowledge of the uncertainty of a measurement provides
additional confidence in a result’s validity. Its value accounts for all the factors which could
possibly affect the result, such as adequacy of analyte definition, sampling, matrix effects and
interferences, climatic conditions, variances in weights, volumes, and standards, analytical
procedure, and random variation. Some national accreditation organizations require the use of
an “expanded uncertainty” defined as the range within which the value of the measurand is
believed to lie within at least a 95% confidence level with the coverage factor k=2.
19.13.2 Uncertainty is not error. Error is a single value (i.e., the difference between the true
result and the measured result). On environmental samples, the true result is never known. The
measurement is the sum of the unknown true value and the unknown error. Unknown error is a
combination of systematic error, or bias, and random error. Bias varies predictably, constantly,
and independently from the number of measurements. Random error is unpredictable, assumed
to be Gaussian in distribution, and reducible by increasing the number of measurements.
19.13.3 The minimum uncertainty associated with results generated by the laboratory can be
determined by using the Laboratory Control Sample (LCS) accuracy range for a given analyte.
The LCS limits are used to assess the performance of the measurement system since they take
into consideration all of the laboratory variables associated with a given test over time (except for
variability associated with the sampling and the variability due to matrix effects). The percent
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recovery of the LCS is compared either to the method-required LCS accuracy limits or to the
statistical, historical, in-house LCS accuracy limits.
19.13.4 To calculate the uncertainty for the specific result reported, multiply the result by the
decimal of the lower end of the LCS range percent value for the lower end of the uncertainty
range, and multiply the result by the decimal of the upper end of the LCS range percent value for
the upper end of the uncertainty range. These calculated values represent uncertainties at
approximately the 99% confidence level with a coverage factor of k = 3. To include the bias when
the median/mean of the recovery range is not 100%, divide the range percent values by the
median/mean of the recovery range (in % as well). As an example, for a reported result of 1.0
mg/L with an LCS recovery range of 70 to 110%, the estimated uncertainty in the result would be
calculated as follows:
𝐿𝑚𝑤𝑒𝑟 𝑈𝑚𝑐𝑒𝑟𝑡𝑎𝑖𝑚𝑡𝑦=𝐶 × (𝐿𝑚𝑤𝑒𝑟 𝐿𝑖𝑚𝑖𝑡 (%)
𝐿𝑒𝑎𝑚(%))=1 × (70
90)=0.78 𝑚𝑔/𝐿
𝑈𝑚𝑚𝑒𝑟 𝑈𝑚𝑐𝑒𝑟𝑡𝑎𝑖𝑚𝑡𝑦=𝐶 × (𝑈𝑚𝑚𝑒𝑟 𝐿𝑖𝑚𝑖𝑡 (%)
𝐿𝑒𝑎𝑚(%))=1 × (110
90 )=1.22 𝑚𝑔/𝐿
Where C = the reported result, and the mean is the mean of the recovery range.
Thus, the uncertainty for this example after bias correction is 0.78 – 1.22 mg/L.
19.13.5 In the case where a well-recognized test method specifies limits to the values of major
sources of uncertainty of measurement (e.g., 524.2, 525, etc.) and specifies the form of
presentation of calculated results, no further discussion of uncertainty is required.
19.14 Sample Reanalysis Guidelines
Because there is a certain level of uncertainty with any analytical measurement, a sample re-
preparation (where appropriate) and subsequent analysis (hereafter referred to as ‘reanalysis’)
may result in either a higher or lower value from an initial sample analysis. There are also
variables that may be present (e.g., sample homogeneity, analyte precipitation over time, etc.)
that may affect the results of a reanalysis. Based on the above comments, the laboratory will
reanalyze samples at a client’s request with the following caveats. Client specific Contractual
Terms & Conditions for reanalysis protocols may supersede the following items.
Homogenous samples: If a reanalysis agrees with the original result to within the RPD limits for
MS/MSD or Duplicate analyses, or within ± 1 reporting limit for samples ≤ 5x the reporting limit,
the original analysis will be reported. At the client’s request, both results may be reported on the
same report but not on two separate reports.
 If the reanalysis does not agree (as defined above) with the original result, then the laboratory
will investigate the discrepancy and reanalyze the sample a third time for confirmation if
sufficient sample is available.
 Any potential charges related to reanalysis are discussed in the contract terms and conditions
or discussed at the time of the request. The client will typically be charged for reanalysis
unless it is determined that the lab was in error.
 Due to the potential for increased variability, reanalysis may not be applicable to Non-
homogenous, Encore, and Sodium Bisulfate preserved samples. See the Area Supervisor or
Laboratory Director if unsure.
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19.15 Control of Data
The laboratory has policies and procedures in place to ensure the authenticity, integrity, and
accuracy of the analytical data generated by the laboratory.
19.15.1 Computer and Electronic Data Related Requirements
The three basic objectives of our computer security procedures and policies are shown below.
The laboratory is currently using the Eurofins LIMS system, which has been highly customized to
meet the needs of the laboratory.
19.15.1.1 Maintain the Database Integrity – Assurance that data is reliable and accurate through
data verification (review) procedures, password-protecting access, anti-virus protection, data
change requirements, as well as an internal LIMS permissions procedure.
 LIMS Database Integrity is achieved through data input validation, internal user controls,
documentation of system failures and corrective actions taken, and data change
requirements.
 Spreadsheets and other software developed in-house must be verified with documentation
through hand calculations prior to use. Cells containing calculations must be lock-protected
and controlled.
 Instrument hardware and software adjustments are safeguarded through maintenance logs,
audit trails and controlled access.
19.15.1.2 Ensure Information Availability – Protection against loss of information or service is
ensured through scheduled back-ups, stable file server network architecture, secure storage of
media, line filter, Uninterruptible Power Supply (UPS), and maintaining older versions of software
as revisions are implemented.
19.15.1.3 Maintain Confidentiality – Ensure data confidentiality through physical access controls
such as password protection or website access approval when electronically transmitting data.
19.15.2 Data Reduction
The complexity of the data reduction depends on the analytical method and the number of discrete
operations involved (e.g., extractions, dilutions, instrument readings and concentrations). The
analyst calculates the final results from the raw data or uses appropriate computer programs to
assist in the calculation of final reportable values.
For manual data entry, e.g., Wet Chemistry, the data is reduced by the analyst and then verified
by the Department Manager or alternate analyst prior to updating the data in LIMS. The
spreadsheets, or any other type of applicable documents, are signed by both the analyst and
alternate reviewer to confirm the accuracy of the manual entry(s).
Manual integration of peaks will be documented and reviewed and the raw data will be flagged
using laboratory SOP No. WS-PQA-011, Manual Integration Documentation and Practices.
Analytical results are reduced to appropriate concentration units specified by the analytical
method, taking into account factors such as dilution, sample weight or volume, etc. Blank correction
will be applied only when required by the method or per manufacturer’s indication; otherwise, it should
not be performed. Calculations are independently verified by appropriate laboratory staff.
Calculations and data reduction steps for various methods are summarized in the respective
analytical SOPs or program requirements.
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19.15.2.1 All raw data must be retained in the worklist folder, computer file (if appropriate), and/or
runlog. All criteria pertinent to the method must be recorded. The documentation is recorded at
the time observations or calculations are made and must be signed or initialed/dated
(month/day/year). It must be easily identifiable who performed which tasks if multiple people were
involved.
19.15.2.2 In general, concentration results are reported in milligrams per liter (mg/l) or
micrograms per liter (μg/l) for liquids and milligrams per kilogram (mg/kg) or micrograms per
kilogram (μg/kg) for solids. For values greater than 10,000 mg/l, results can be reported in
percent, i.e., 10,000 mg/l = 1%. Units are defined in each lab SOP.
19.15.2.3 In reporting, the analyst or the instrument output records the raw data result using
values of known certainty plus one uncertain digit. If final calculations are performed external to
LIMS, the results should be entered in LIMS with at least three significant figures. In general,
results are reported to 2 significant figures on the final report.
19.15.2.4 For those methods that do not have an instrument printout or an instrumental output
compatible with the LIMS, the raw results and dilution factors are entered directly into LIMS by
the analyst, and the software calculates the final result for the analytical report. LIMS has a
formatter for significant figure criteria for each analyte.
19.15.2.5 The laboratory strives to import data directly from instruments or calculation
spreadsheets to ensure that the reported data are free from transcription and calculation errors.
For those analyses with an instrumental output compatible with LIMS, the raw results and dilution
factors are transferred into LIMS electronically after reviewing the quantitation report, and
removing unrequested or poor spectrally-matched compounds. The analyst may print a copy of
what has been entered to check for errors. This printout and the instrument’s data file of
calibrations, concentrations, retention times, chromatograms, and mass spectra, if applicable, are
retained within Chrom or LIMS, based on the type of data.
19.15.3 Logbook / Worksheet Use Guidelines
Logbooks and worksheets are filled out ‘real time’ and have enough information on them to trace
the events of the applicable analysis/task. (e.g. calibrations, standards, analyst, sample ID, date,
time on short holding time tests, temperatures when applicable, calculations are traceable, etc.)
 Corrections are made following the procedures outlined in Section 14.
 Logbooks are controlled by the QA department. A record is maintained of all logbooks in the
lab.
 Unused portions of pages must be “Z’d” out, signed and dated.
 Worksheets are created with the approval of the Technical Manager/QA Manager at the
facility. The QA Department controls all worksheets following the procedures in Section 6.
19.15.4 Review / Verification Procedures
Review procedures are outlined in several laboratory SOPs (WS-PQA-003, “Quality Control
Program”, WS-PQA-012, “Technical Data Review Requirements”, WS-PM-0001, “Final Report
Assembly and Third Level Data Review”) to ensure that reported data are free from calculation
and transcription errors, that QC parameters have been reviewed and evaluated before data is
reported. The laboratory also has an SOP discussing Manual Integrations to ensure the
authenticity of the data (WS-PQA-011, “Manual Integration Documentation and Practices”). The
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general review concepts are discussed below, more specific information can be found in the
SOPs.
19.15.4.1 Log-In Review - The data review process starts at the sample receipt stage. Sample
control personnel review chain-of-custody forms and project instructions from the project
management group. This is the basis of the sample information and analytical instructions
entered into the LIMS. The log-in instructions are reviewed by the personnel entering the
information, and a second level review is conducted by the project management staff.
19.15.4.2 First Level Data Review - The next level of data review occurs with the analysts. As
data are generated, analysts review their work to ensure that the results meet project and SOP
requirements. First level reviews include inspection of all raw data (e.g., instrument output for
continuous analyzers, chromatograms, spectra, and manual integrations), evaluation of
calibration/calibration verification data in the day’s analytical run, evaluation of QC data, and
reliability of sample results. The analyst transfers data into LIMS, data qualifiers are added as
needed. All first level reviews are documented.
19.15.4.3 Second Level Data Review – All analytical data are subject to review by a second
qualified analyst or supervisor. Second level reviews include inspection of all raw data (e.g.,
instrument output, chromatograms, and spectra) including 100% of data associated with any
changes made by the primary analyst, such as manual integrations or reassignment of peaks to
different analytes, or elimination of false negative analytes. The second review also includes
evaluation of initial calibration/calibration verification data in the day’s analytical run, evaluation of
QC data, reliability of sample results, qualifiers and NCM narratives. Manual calculations are
checked in second level review. All second level reviews are documented.
Issues that deem further review include the following:
 QC data are outside the specified control limits for accuracy and precision
 Reviewed sample data does not match with reported results
 Unusual detection limit changes are observed
 Samples having unusually high results
 Samples exceeding a known regulatory limit
 Raw data indicating some type of contamination or poor technique
 Inconsistent peak integration
 Transcription errors
 Results outside of calibration range
19.15.4.4 Unacceptable analytical results may require reanalysis of the samples. Any problems
are brought to the attention of the Laboratory Director, Project Manager, Quality
Director/Manager, Technical Manager, or Supervisor for further investigation. Corrective action
is initiated whenever necessary.
19.15.4.5 The results are then entered or directly transferred into the computer database and a
.pdf is printed for the client.
19.15.4.6 As a final review prior to the release of the report, the Project Manager reviews the
results for appropriateness and completeness. This review and approval ensures that client
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requirements have been met and that the final report has been properly completed. The process
includes, but is not limited to, verifying that the COC is followed, cover letters / narratives are
present, flags are appropriate, and project specific requirements are met. The Project Manager
may also evaluate the validity of results for different test methods given expected chemical
relationships.
19.15.4.7 Any project that requires a data package is subject to a tertiary data review for
transcription errors and acceptable quality control requirements. The Project Manager then signs
the final report. The accounting personnel also check the report for any clerical or invoicing errors.
When complete, the report is sent out to the client.
19.15.4.8 A brief overview of sample flow and information through the laboratory, as well as data
review and validation, is presented in Figure 19-1.
19.15.5 Manual Integrations
Computerized data systems provide the analyst with the ability to re-integrate raw instrument data
in order to optimize the interpretation of the data. Though manual integration of data is an
invaluable tool for resolving variations in instrument performance and some sample matrix
problems, when used improperly, this technique would make unacceptable data appear to meet
quality control acceptance limits. Improper re-integrations lead to legally indefensible data, a poor
reputation, or possible laboratory decertification. Because guidelines for re-integration of data
are not provided in the methods and most methods were written prior to widespread
implementation of computerized data systems, the laboratory trains all analytical staff on proper
manual integration techniques using SOP WS-PQA-011, “Manual Integration Documentation and
Practices” which is based on NDSC Document No. NDSC-QA-SOP43862, Acceptable Manual
Integration Practices.
19.15.5.1 The analyst must adjust baseline or the area of a peak in some situations, for example
when two compounds are not adequately resolved or when a peak shoulder needs to be
separated from the peak of interest. The analyst must use professional judgment to determine
when manual integrating is required. Analysts are encouraged to ask for assistance from a senior
analyst or manager when in doubt.
19.15.5.2 Analysts shall not increase or decrease peak areas for the sole purpose of achieving
acceptable QC recoveries that would have otherwise been unacceptable. The intentional
recording or reporting of incorrect information (or the intentional omission of correct information)
is against company principles and policy and is grounds for immediate termination.
19.15.5.3 Client samples, performance evaluation samples, and quality control samples are all
treated equally when determining whether or not a peak area or baseline should be manually
adjusted.
19.15.5.4 All manual integrations receive a second level review. Manual integrations must be
indicated on an expanded scale “before” and “after” chromatograms such that the integration
performed can be easily evaluated during data review. Expanded scale “before” chromatograms
are also required for all manual integrations on QC parameters (calibrations, calibration
verifications, laboratory control samples, internal standards, surrogates, etc.).

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Figure 19-1. Example – Work Flow
Action Personnel Involved
Bottle orders generated upon request
- Bottles packed and shipped to the client under CoC
- Client Service Personnel / PM
- Bottle Preparation Personnel
Samples received at laboratory
- Unpacked and reconciled against client paperwork or
CoC
- Samples acceptance documented against completed
(CoC)1
Sample Login Personnel
Samples are entered into LIMS
- Job # assigned
- Methods/Analytes linked from project
- Sample labels generated
- LIMS backlogs updated immediately
Sample Login Personnel
Sample Storage
- Short TATs and hold-time samples are delivered directly
to the laboratory for analysis
- Samples stored in assigned locations (refrigerated walk -
in coolers, freezers, VOA refrigerators; etc.)
Sample Login Personnel
Sample Receipt Acknowledgement sent to client (when
requested)
Sample Login Personnel
Sample Acquisition/Testing
- Analysts collect samples from assigned storage.
- Legal CoC samples are signed in-and-out of storage
- Remaining sample returned to storage.
Analysts / Login Personnel
Preparation and analysis is performed according to
selected analytical method and applicable Project notes
- Raw data recorded/reviewed2
- Data imported to LIMS
Analysts
LIMS performs calculations:
- Data reviewed by primary/secondary analyst
- Data approved as final
Data Process
(LIMS / Analyst )
Generation/review/release of reports (automated through
LIMS)
- Electronic copy saved in LIMS
Project Management Assistants /
Reporting Group
Electronic Data Deliverables (EDDs) generated (as
applicable)
EDD Group
Hard copy and electronic batch raw data is archived
according to data archiving procedures.
Analysts / IT
1Refer to Sec. 23.3.
2Analyses requiring the analyst’s interpretation may involve manual data reduction before entry into LIMS.
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20.0 EQUIPMENT and CALIBRATIONS
20.1 Overview
The laboratory purchases the most technically advanced analytical instrumentation for sample
analyses. Instrumentation is purchased on the basis of accuracy, dependability, efficiency and
sensitivity. Each laboratory is furnished with all items of sampling, preparation, analytical testing
and measurement equipment necessary to correctly perform the tests for which the laboratory
has capabilities. Each piece of equipment is capable of achieving the required accuracy and
complies with specifications relevant to the method being performed. Before being placed into
use, the equipment (including sampling equipment) is calibrated and checked to establish that it
meets its intended specification. The calibration routines for analytical instruments establish the
range of quantitation. Calibration procedures are specified in laboratory SOPs. A list of available
laboratory instrumentation is presented in Table 20-1.
Equipment is only operated by authorized and trained personnel. Manufacturer’s instructions for
equipment use are readily accessible to all appropriate laboratory personnel.
20.2 Preventive Maintenance
The laboratory follows a well-defined maintenance program to ensure proper equipment
operation and to prevent the failure of laboratory equipment or instrumentatio n during use. This
program of preventive maintenance helps to avoid delays due to instrument failure.
Routine preventive maintenance procedures and frequency, such as cleaning and replacements,
should be performed according to the procedures outlined in the manufacturer's manual. Qualified
personnel must also perform maintenance when there is evidence of degradation of peak
resolution, a shift in the calibration curve, loss of sensitivity, or failure to continually meet one of
the quality control criteria.
Scheduled routine maintenance is defined in each method SOP. It is the responsibility of each
Technical Manager to ensure that instrument maintenance logs are kept for all equipment in
his/her department. Preventative maintenance procedures are also outlined in analytical SOPs or
instrument manuals. (Note: for some equipment, the log used to monitor performance is also the
maintenance log. Multiple pieces of equipment may share the same log as long as it is clear as to
which instrument is associated with an entry.)
Instrument maintenance logs are controlled and are used to document instrument problems,
instrument repair and maintenance activities. Maintenance logs shall be kept for all major pieces
of equipment. Instrument maintenance logs may also be used to specify instrument parameters.
 Documentation must include all major maintenance activities such as contracted preventive
maintenance and service and in-house activities such as the replacement of electrical
components, lamps, tubing, valves, columns, detectors, cleaning and adjustments.
 Each entry in the instrument log includes the analyst's initials, the date, a detailed description of
the problem (or maintenance needed/scheduled), a detailed explanation of the solution or
maintenance performed, and a verification that the equipment is functioning properly (state what
was used to determine a return to control. e.g. CCV run on ‘date’ was acceptable, or
instrument recalibrated on ‘date’ with acceptable verification, etc.) must also be documented
in the instrument records.
 When maintenance or repair is performed by an outside agency, service receipts detailing the
service performed can be affixed into the logbooks adjacent to pages describing the
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maintenance performed. This stapled in page must be signed across the page entered and
the logbook so that it is clear that a page is missing if only half a signature is found in the
logbook.
If an instrument requires repair (subjected to overloading or mishandling), gives suspect results, or
otherwise has shown to be defective or outside of specified limits it shall be taken out of operation
and tagged as out-of-service or otherwise isolated until such a time as the repairs have been made
and the instrument can be demonstrated as operational by calibration and/or verification or other
test to demonstrate acceptable performance. The laboratory shall examine the effect of this defect
on previous analyses.
In the event of equipment malfunction that cannot be resolved, service shall be obtained from the
instrument vendor manufacturer, or qualified service technician, if such a service can be tendered.
If on-site service is unavailable, arrangements shall be made to have the instrument shipped back
to the manufacturer for repair. Back up instruments, which have been approved, for the analysis
shall perform the analysis normally carried out by the malfunctioning instrument. If the back-up
is not available and the analysis cannot be carried out within the needed timeframe, the samples
shall be subcontracted.
At a minimum, if an instrument is sent out for service or transferred to another facility, it must be
recalibrated and the laboratory MDL verified (using an MDLV) prior to return to lab operations.
20.3 Support Equipment
This section applies to all devices that may not be the actual test instrument, but are necessary
to support laboratory operations. These include but are not limited to: balances, ovens,
refrigerators, freezers, incubators, water baths, temperature measuring devices, thermal/pressure
sample preparation devices and volumetric dispensing devices if quantitative results are
dependent on their accuracy, as in standard preparation and dispensing or dilution into a specified
volume. All raw data records associated with the support equipment are retained to document
instrument performance.
20.3.1 Weights and Balances
The accuracy of the balances used in the laboratory is checked every working day, before use.
All balances are placed on stable counter tops.
Each balance is checked prior to initial serviceable use with at least two certified ASTM type 1
weights spanning its range of use (weights that have been calibrated to ASTM type 1 weights
may also be used for daily verification). ASTM type 1 weights used only for calibration of other
weights (and no other purpose) are inspected for corrosion, damage or nicks at least annually
and if no damage is observed, they are calibrated at least every 5 years by an outside calibration
laboratory. Any weights (including ASTM Type 1) used for daily balance checks or other
purposes are recalibrated/recertified annually to NIST standards (this may be done internally if
laboratory maintains “calibration only” ASTM type 1 weights).
All balances are serviced annually by a qualified service representative, who supplies the
laboratory with a certificate that identifies traceability of the calibration to the NIST standards.
All of this information is recorded in logs, and the recalibration/recertif ication certificates are kept
on file. See SOP No. WS-QA-0041, Calibration and Calibration Check of Balances for more
details.
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20.3.2 pH, Conductivity, and Turbidity Meters
The pH meters used in the laboratory are accurate to ± 0.1 pH units, and have a scale readability
of at least 0.05 pH units. The meters automatically compensate for the temperature, and are
calibrated with at least two working range buffer solutions before each use.
Conductivity meters used in the laboratory are capable or measuring conductivity with an error
not exceeding 1% or one umhos/cm, whichever is greater. The meters are also calibrated before
each use with a known standard.
Turbidity meters are also calibrated before each use. All of this information is documented in
logs.
Consult pH, Conductivity, and Turbidity SOPs for further information.
20.3.3 Thermometers
All thermometers are calibrated on an annual basis with a NIST -traceable thermometer at
temperatures bracketing the range of use.
 If the temperature measuring device is used over a range of 10°C or less, then a single point
verification within the range of use is acceptable;
 If the temperature measuring device is used over a range of greater than 10°C, then the
verification must bracket the range of use.
IR thermometers, digital probes and thermocouples are calibrated quarterly. IR Thermometers
should be calibrated over the full range of use, including ambient, iced (4 degrees) and frozen (0
to -5 degrees), per the Drinking Water Manual.
The digital NIST thermometer is recalibrated every five years (unless the thermometer has been
exposed to extreme temperatures) by an approved outside service and the provided certificate of
traceability is kept on file. Alternately a new NIST thermometer with certificate of traceability from
the manufacturer may be purchased. The NIST thermometer(s) have increments of 1 degree or
smaller (0.5 degree or less increments are required for drinking water microbiological
laboratories), and have ranges applicable to method and certification requirements. The NIST
traceable thermometer is used for no other purpose than to calibrate other thermometers.
All of this information is documented in logbooks. Monitoring method-specific temperatures,
including heating blocks, water baths, and ovens, is documented in method-specific logbooks.
More information on this subject can be found in the SOP No. WS-QA-0016, “Thermometer
Calibration.”
20.3.4 Refrigerators/Freezer Units, Water baths, Ovens and Incubators
The temperatures of all refrigerator units and freezers used for sample storage are monitored 7
days a week; and each working day for units used for standard storage.
Ovens and water baths are monitored on days of use. Drying oven temperature must be recorded
before and at the end of use. For example, an oven used for moisture determination must have
its temperature recorded at the start and end of the drying process. Temperature must be ± 5%
of set temperature for DoD/DOE work.
All of this equipment has a unique identification number, and is assigned a thermometer for
monitoring.
Sample storage refrigerator temperatures are kept at > 0ºC and ≤ 6 ºC.
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Specific temperature settings/ranges for other refrigerators, ovens, and water baths can be found
in method specific SOPs.
All of this information is documented in Daily Temperature Logbooks and method-specific
logbooks, and discussed in SOP No. WS-QA-0005, Refrigerator and Freezer Monitoring.
20.3.5 Autopipettors, Dilutors, and Syringes
Mechanical volumetric dispensing devices including burettes (except Class A Glassware and
Glass microliter syringes) are given unique identification numbers and the delivery volumes are
verified gravimetrically, at a minimum on a quarterly basis.
For those dispensers that are not used for analytical measurements, a label shall be applied to
the device stating that it is not calibrated. Any device not regularly verified cannot be used for
any quantitative measurements. See SOP WS-QA-0004, “Maintenance and Calibration Check
of Fixed and Adjustable Volume Autopipettors, Autodispensers and Volumetric Containers”.
Micro-syringes are purchased from Hamilton Company. Each syringe is traceable to NIST. The
laboratory keeps on file an “Accuracy and Precision Statement of Conformance” from Hamilton
attesting established accuracy.
20.4 Instrument Calibrations
Calibration of analytical instrumentation is essential to the production of quality data. Strict
calibration procedures are followed for each method. These procedures are designed to
determine and document the method detection limits, the working range of the analytical
instrumentation and any fluctuations that may occur from day to day.
Sufficient raw data records are retained to allow an outside party to reconstruct all facets of the
initial calibration. Records contain, but are not limited to, the following: calibration date, method,
instrument, analyst(s) initials or signatures, analysis date, analytes, concentration, response, and
type of calibration (Average RF, curve, or other calculations that may be used to reduce
instrument responses to concentration.)
Sample results must be quantitated from the initial calibration and may not be quantitated from
any continuing instrument calibration verification unless otherwise required by regulation, method
or program.
If the initial calibration results are outside of the acceptance criteria, corrective action is performed
and any affected samples are reanalyzed if possible. If the reanalysis is not possible, any data
associated with an unacceptable initial calibration will be reported with appropriate data qualifiers
(refer to Section 14).
Note: Instruments are calibrated initially and as needed after that and at least annually (the
annual requirement does not apply to Isotope Dilution Methods).
20.4.1 Calibration Standards
Calibration standards are prepared using the procedures indicated in the Reagents and
Standards section of the determinative method SOP. If a reference method does not specify the
number of calibration standards, a minimum of 3 calibration points will be used.
Standards for instrument calibration are obtained from a variety of sources. All standards are
traceable to national or international standards of measurement, or to national or international
standard reference materials.
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The lowest concentration calibration standard that is analyzed during an initial calibration must be
at or below the stated reporting limit for the method based on the final volume of extract (or
sample).
The other concentrations define the working range of the instrument/method or correspond to the
expected range of concentrations found in actual samples that are also within the working range
of the instrument/method. Results of samples not bracketed by initial instrument calibration
standards (within calibration range to at least the same number of significant figures used to report
the data) must be reported as having less certainty, e.g., defined qualifiers or flags (additional
information may be included in the case narrative). The exceptions to these rules are the ICP
and ICPMS methods which define the working range with periodic linear dynamic range studies,
rather than through the range of concentrations of daily calibration standards.
All initial calibrations are verified with a standard obtained from a second source and traceable to
a national standard, when available (or vendor certified different lot if a second source is not
available). For unique situations, such as PFAS analysis where no other source or lot is available,
a standard made by a different analyst at a different time or a different preparation would be
considered a second source. This verification occurs immediately after the calibration curve has
been analyzed, and before the analysis of any samples.
20.4.1.1 Calibration Verification
The calibration relationship established during the initial calibration must be verified initially and
at least daily as specified in the laboratory method SOPs in accordance with the referenced
analytical methods and in the 2009 and 2016 TNI Standard. The process of calibration verification
applies to both external standard and internal standard calibration techniques, as well as to linear
and non-linear calibration models. Initial calibration verification (ICV) is with a standard source
secondary (second source standard) to the calibration standards, but continuing calibration
verifications (CCV) may use the same source standards as the calibration curve.
Note: The process of calibration verification referred to here is fundamentally different from
the approach called "calibration" in some methods. As described in those methods, the calibration
factors or response factors calculated during calibration are used to update the calibration factors
or response factors used for sample quantitation. This approach, while employed in other EPA
programs, amounts to a daily single-point calibration.
All target analytes and surrogates, including those reported as non-detects, must be included in
periodic calibration verifications for purposes of retention time confirmation and to demonstrate
that calibration verification criteria are being met, i.e., RPD, per 2009 and 2016 TNI Std. EL-V1M4
Sec. 1.7.2.
All samples must be bracketed by periodic analyses of standards that meet the QC acceptance
criteria (e.g., calibration and retention time). The frequency is found in the determinative methods
or SOPs.
Note: If an internal standard calibration is being used then bracketing standards may not be
required, only daily verifications are needed. (Exception: Some QC programs, such as the
DoD/DOE QSM Version 5.4, require bracketing standards with internal standard calibration). The
results from these verification standards must meet the calibration verification criteria and the
retention time criteria (if applicable).
Generally, the calibrations must be verified by an ICV analyzed immediately following initial
calibration and before sample analysis. The ICV may be used as the first bracketing CCV, if
criteria for both are met.
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A continuing instrument calibration verif ication (CCV) is generally analyzed at the beginning of
each 12-hour analytical shift during which samples are analyzed. The 12-hour analytical shift
begins with the injection of the calibration verification standard (or the MS tuning standard in MS
methods). The shift ends after the completion of the analysis of the last sample, QC, or standard
that can be injected within 12-hours of the beginning of the shift. For methods that have
quantitation by external calibration models, a CCV is analyzed at the end of each analytical
sequence. Some methods have more frequent CCV requirements. See specific SOPs. Most
inorganic methods require the CCV to be analyzed after ever 10 samples or injections, including
matrix or batch QC samples.
Note: If an internal standard calibration is being used (e.g., GCMS) then bracketing standards
are not required, only daily verifications are needed, except as specified by program or method
requirements.
If the results of a CCV are outside the established acceptance criteria and analysis of a second
consecutive (and immediate) CCV fails to produce results within acceptance criteria, corrective
action shall be performed. Once corrective actions have been completed and documented, the
laboratory shall demonstrate acceptable instrument / method performance by analyzing two
consecutive CCVs, or a new initial instrument calibration shall be performed.
Sample analyses and reporting of data may not occur or continue until the analytical system is
calibrated or calibration verified. However, data associated with an unacceptable calibration
verification may be fully useable reported based upon discussion and approval of the client under
the following special conditions:
a) when the acceptance criteria for the CCV are exceeded high (i.e., high bias) and the associated
samples within the batch are non-detects, then those non-detects may be reported case narrative
comment explaining the high bias. Otherwise the samples affected by the unacceptable CCV
shall be re-analyzed after a new calibration curve has been established, evaluated and accepted;
or
b) when the acceptance criteria for the CCV are exceeded low (i.e., low bias), those sample
results may be reported if they exceed a maximum regulatory limit/decision level. Otherwise the
samples affected by the unacceptable CCV shall be re-analyzed after a new calibration curve has
been established, evaluated and accepted.
Samples reported by the 2 conditions identified above will be appropriately flagged.
20.4.1.2 Verification of Linear and Non-Linear Calibrations
Calibration verification for calibrations involves the calculation of the percent drift or the percent
difference of the instrument response between the initial calibration and each subsequent analysis
of the verification standard. (These calculations are available in the laboratory method SOPs.)
Verification standards are evaluated based on the % Difference from the average CF or RF of the
initial calibration or based on % Drift or % Recovery if a linear or quadratic curve is used.
Regardless of whether a linear or non-linear calibration model is used, if initial verification criterion
is not met, then no sample analyses may take place until the calibration has been verified or a
new initial calibration is performed that meets the specifications listed in the method SOPs. If the
calibration cannot be verified after the analysis of a single verification standard, then adjust the
instrument operating conditions and/or perform instrument maintenance, and analyze another
aliquot of the verification standard. If the calibration cannot be verified with the second standard,
then a new initial calibration is performed.
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 When the acceptance criteria for the calibration verification are exceeded high, i.e., high bias,
and there are associated samples that are non-detects, then those non-detects may be
reported. Otherwise, the samples affected by the unacceptable calibration verif ication shall
be reanalyzed after a new calibration curve has been established, evaluated and accepted.
 When the acceptance criteria for the calibration verif ication are exceeded low, i.e., low bias,
those sample results may be reported if they exceed a maximum regulatory limit/decision
level. Otherwise, the samples affected by the unacceptable verification shall be reanalyzed
after a new calibration curve has been established, evaluated and accepted. Alternatively, a
reporting limit standard may be analyzed to demonstrate that the laboratory can still support
non-detects at their reporting limit.
20.5 Tentatively Identified Compounds (TICs) – GC/MS Analysis
For samples containing components not associated with the calibration standards, a library
search may be made for the purpose of tentative identification. The necessity to perform this type
of identification will be determined by the purpose of the analyses being conducted. Data system
library search routines should not use normalization routines that would misrepresent the library
or unknown spectra when compared to each other.
Note: If the TIC compound is not part of the client target analyte list but is calibrated by the
laboratory and is both qualitatively and/or quantitatively identifiable, it should not be reported as
a TIC. If the compound is reported on the same form as true TICs, it should be qualified and/or
narrated that the reported compound is qualitatively and quantitatively (if verif ication in control)
reported compared to a known standard that is in control (where applicable).
20.6 GC/MS Tuning
Prior to any GC/MS analytical sequence, including calibration, the instrument parameters for the
tune and subsequent sample analyses within that sequence must be set.
Prior to tuning/auto-tuning the mass spectrometer, the parameters may be adjusted within the
specifications set by the manufacturer or the analytical method. These generally do not need any
adjustment but it may be required based on the current instrument performance. If the tune
verification does not pass it may be necessary to clean the source or perform additional
maintenance. Any maintenance is documented in the maintenance log.
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Table 20-1. Instrumentation List
Instrument Type Number in Use
Autoanalyzer 1
Autotitrator 1
Conductivity Meter 1
Cold-Vapor Analyzers 2
Combustion Ion Chromatograph 1
Dissolved Oxygen Meter 1
GC/HRMS 6
GC/MS - Semivolatiles 7
GC/MS - Volatiles 8
GC/MS/MS 1
GC-ECD/ECD 6
GC-FID/FID 3
HPLC/MS/MS 16
ICP 2
ICP/MS 1
Ion Chromatograph 5
Raman Spectrometer 1
UV/Vis Spectrometer 1
Turbidimeter 1
ddPCR 2

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21.0 MEASUREMENT TRACEABILITY
21.1 Overview
Traceability of measurements shall be assured using a system of documentation, calibration, and
analysis of reference standards. Laboratory equipment that are peripheral to analysis and whose
calibration is not necessarily documented in a test method analysis or by analysis of a reference
standard shall be subject to ongoing certifications of accuracy. At a minimum, these must include
procedures for checking specifications of ancillary equipment: balances, thermometers,
temperature, Deionized (DI) and Reverse Osmosis (RO) water systems, automatic pipettes and
other volumetric measuring devices. (Refer to Section 20.3). With the exception of Class A
Glassware and glass microliter syringes, quarterly accuracy checks are performed for all
mechanical volumetric devices. Wherever possible, subsidiary or peripheral equipment is
checked against standard equipment or standards that are traceable to national or international
standards. Class A Glassware and glass microliter syringes should be routinely inspected for
chips, acid etching or deformity (e.g., bent needle). If the Class A glassware or syringe is suspect,
the accuracy of the glassware will be assessed prior to use.
21.2 NIST-Traceable Weights and Thermometers
Reference standards of measurement shall be used for calibration only and for no other purpose,
unless it can be shown that their performance as reference standards would not be invalidated.
For NIST-traceable weights and thermometers, the laboratory requires that all calibrations be
conducted by a calibration laboratory accredited by A2LA, ANAB, NVLAP (National Voluntary
Laboratory Accreditation Program) or another accreditation organization that is a signatory to a
MRA (Mutual Recognition Arrangement) of one or more of the following cooperations – ILAC
(International al Laboratory Accreditation Cooperation) or APLC (Asia-Pacific Laboratory
Accreditation Cooperation). A calibration certificate and scope of accreditation is kept on file at
the laboratory.
21.3 Reference Standards / Materials
Reference standards/materials, where commercially available, are traceable to certified reference
materials. Commercially prepared reference standards are purchased from vendors that are
accredited to ISO/IEC Standard 17034 and ISO/IEC Guide 17025. All reference standards from
commercial vendors shall be accompanied with a certificate that includes at least the following
information:
 Manufacturer
 Analytes or parameters calibrated
 Identification or lot number
 Calibration method
 Concentration with associated uncertainties
 Purity
If a standard cannot be purchased from a vendor that supplies a Certificate of Analysis, the purity
of the standard is documented by analysis. The receipt of all reference standards must be
documented. Reference standards are labeled with a unique Standard Identification Number and
expiration date. All documentation received with the reference standard is retained as a QC
record and references the Standard Identification Number.
All reference, primary and working standards/materials, whether commercially purchased or
laboratory prepared, must be checked regularly to ensure that the variability of the standard or
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material from the true value does not exceed method requirements. The accuracy of calibration
standards is checked by comparison with a standard from a second source. In cases where a
second standard manufacturer is not available, a vendor certified different lot is acceptable for
use as a second source. For unique situations, such as PFAS analysis where no other source or
lot is available, a standard made by a different analyst would be considered a second source.
The appropriate Quality Control (QC) criteria for specific standards are defined in laboratory
SOPs. In most cases, the analysis of an Initial Calibration Verification (ICV) or LCS (where there
is no sample preparation) is used as the second source confirmation. These checks are generally
performed as an integral part of the analysis method (e.g. calibration checks, laboratory control
samples).
All standards and materials must be stored and handled according to method or manufacturer’s
requirements in order to prevent contamination or deterioration. Refer to the Environmental
Health & Safety Manual or laboratory SOPs. For safety requirements, please refer to method
SOPs and the laboratory’s Environmental Health and Safety Manual.
Standards and reference materials shall not be used after their expiration dates unless their
reliability is verified by the laboratory and their use is approved by the Quality Assurance Manager.
The laboratory must have documented contingency procedures for re-verifying expired
standards.
21.4 Documentation and Labeling of Standards, Reagents, and Reference Materials
Reagents must be at a minimum the purity required in the test method. The date of reagent
receipt and the expiration date are documented. The lots for most of the common solvents and
acids are tested for acceptability prior to company-wide purchase. Refer to NDSC Document No.
NDSC-QA-SOP46704, Acid and Solvent Testing and Approval Program.
All manufacturer or vendor supplied Certificate of Analysis or Purity must be retained, stored
appropriately, and readily available for use and inspection. These records are scanned and
maintained on the local server, and attached to the reagent preparation record in the LIMS.
Records must be kept of the date of receipt and date of expiration of standards, reagents and
reference materials. In addition, records of preparation of laboratory standards, reagents, and
reference materials must be retained, stored appropriately, and be readily available for use and
inspection. For detailed information on documentation and labeling, please refer to method
specific SOPs and SOP No. WS-QA-0017, Standards and Reagents and Quality Control Check
Procedures.
Commercial materials purchased for preparation of calibration solutions, spike solutions, etc.., are
usually accompanied with an assay certificate or the purity is noted on the label. If the assay purity
is 96% or better, the weight provided by the vendor may be used without correction. If the assay
purity is less than 96% a correction will be made to concentrations applied to solutions prepared
from the stock commercial material (for 1613B dioxin/furan analyses the purity must be 98% or
corrections must be made).
21.4.1 All standards, reagents, and reference materials must be labeled in an unambiguous
manner. Standards are logged into the laboratory’s LIMS, and are assigned a unique
identification number. The following information is typically recorded in the electronic database
within the LIMS.
 Standard ID
 Description of Standard
 Department
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 Preparer’s name
 Final volume and number of vials prepared
 Solvent type and lot number
 Preparation Date
 Expiration Date
 Standard source type (stock or daughter)
 Standard type (spike, surrogate, other)
 Parent standard ID (if applicable)
 Parent Standard Analyte Concentration (if applicable)
 Parent Standard Amount used (if applicable)
 Component Analytes
 Final concentration of each analyte
 Comment box (text field)
Records are maintained electronically for standard and reference material preparation. These
records show the traceability to purchased stocks or neat compounds. These records also include
method of preparation, date of preparation, expiration date and preparer’s name or initials.
Preparation procedures are provided in the Method SOPs.
21.4.2 All standards, reagents, and reference materials must be clearly labeled with a
minimum of the following information:
 Expiration Date (include prep date for reagents)
 Standard ID (from LIMS or the preparation logbook)
 Special Health/Safety warnings if applicable
Records must also be maintained of the date of receipt for commercially purchased items or date
of preparation for laboratory prepared items. Special Health/Safety warnings must also be
available to the analyst. This information is maintained in the SDS section of EET-Net.
21.4.3 In addition, the following information may be helpful:
 Date opened (for multi-use containers, if applicable)
 Description of standard (if different from manufacturer’s label or if standard was prepared in
the laboratory)
 Recommended Storage Conditions
 Concentration (if applicable)
 Initials of analyst preparing standard or opening container
All containers of prepared reagents must include an expiration date and an ID number to trace
back to preparation.
Procedures for preparation of reagents can be found in the Method SOPs.
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Standard ID numbers must be traceable through associated logbooks, worksheets and
preparation/analytical batch records.
All reagents and standards must be stored in accordance to the following priority: 1) with the
manufacturer’s recommendations; 2) with requirements in the specific analytical methods as
specified in the laboratory SOP.
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22.0 SAMPLING
22.1 Overview
The laboratory does not provide sampling services. The laboratory’s responsibility in the sample
collection process lies in supplying the sampler with the necessary coolers, reagent water, sample
containers, preservatives, sample labels, custody seals, COC forms, ice, and packing materials
required to properly preserve, pack, and ship samples to the laboratory.
22.2 Sampling Containers
The laboratory offers clean sampling containers for use by clients. These containers are obtained
from reputable container manufacturers and meet EPA specif ications as required. Certificates of
cleanliness for bottles and preservatives are provided by the supplier and are maintained at the
laboratory. Alternatively, the certificates may be maintained by the supplier and available to the
laboratory on-line.
22.2.1 Preservatives
Upon request, preservatives are provided to the client in pre-cleaned sampling containers. In
some cases containers may be purchased pre-preserved from the container supplier. Whether
prepared by the laboratory or bought pre-preserved, the grades of the preservatives are at a
minimum:
 Hydrochloric Acid – Reagent ACS (Certified VOA Free) or equivalent
 Methanol – Purge and Trap grade
 Nitric Acid – Instra-Analyzed or equivalent
 Sodium Bisulfate – ACS Grade or equivalent
 Sodium Hydroxide – Instra-Analyzed or equivalent
 Sulfuric Acid – Instra-Analyzed or equivalent
 Sodium Thiosulfate – ACS Grade or equivalent
 Ammonium Acetate – Fisher Optima LCMS grade or equivalent
 Trizma – Biotechnology performance certified or equivalent
22.3 Definition of Holding Time
The date and time of sampling documented on the COC form establishes the day and time zero.
As a general rule, when the maximum allowable holding time is expressed in days (e.g., 14 days,
28 days), the holding time is based on calendar day measured. Holding times expressed in hours
(e.g., 6 hours, 24 hours, etc.) are measured from date and time zero. Holding times for analysis
include any necessary reanalysis. However, there are some programs that determine holding time
compliance based on the date and specific time of analysis compared to the time of sampling
regardless of how long the holding time is.
22.4 Sampling Containers, Preservation Requirements, Holding Times
The preservation and holding time criteria specified in the laboratory SOPs are derived from the
source documents for the methods. If method required holding times or preservation requirements
are not met, the reports will be qualified using a flag, footnote or case narrative. As soon as
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possible or “ASAP” is an EPA designation for tests for which rapid analysis is advised, but for
which neither EPA nor the laboratory have a basis for a holding time.
22.5 Sample Aliquots / Subsampling
Taking a representative sub-sample from a container is necessary to ensure that the analytical
results are representative of the sample collected in the field. The size of the sample container,
the quantity of sample fitted within the container, and the homogeneity of the sample need
consideration when sub-sampling for sample preparation. It is the laboratory’s responsibility to
take a representative subsample or aliquot of the sample provided for analysis.
Analysts should handle each sample as if it is potentially dangerous. At a minimum, safety
glasses, gloves, and lab coats must be worn when preparing aliquots for analysis.
Guidelines on taking sample aliquots & subsampling are located SOP Nos. WS-QA-0018,
Subsampling and Compositing of Samples (Method ASTM D 6323-98) and WS-QA-0028,
Incremental Sampling Methodology of Soils and Sediments.
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23.0 HANDLING OF SAMPLES
It is the responsibility of the client to send us representative and/or homogeneous and properly
preserved samples of the system from which they are drawn. The laboratory assumes that all
multiple sample containers with the same designator/description and bottle type contain a
homogeneous, representative sample.
The laboratory provides the appropriate sample containers, required preservative, chain-of-
custody (COC) forms, shipping containers, labels, and custody seals. The laboratory also
provides trip blanks and analyte-free water for field blanks. Preparation of methanol containers
for field preservation of volatile soil samples is available.
Sample management procedures at the laboratory ensure that sample integrity and custody are
maintained and documented from sampling/receipt through disposal.
23.1 Chain of Custody (COC)
The COC form is the written documented history of any sample and is initiated when bottles are
sent to the field, or at the time of sampling. This form is completed by the sampling personnel and
accompanies the samples to the laboratory where it is received and stored under the laboratory’s
custody. The purpose of the COC form is to provide a legal written record of the handling of
samples from the time of collection until they are received at the laboratory. It also serves as the
primary written request for analyses from the client to the laboratory. The COC form acts as a
purchase order for analytical services when no other contractual agreement is in effect.
23.1.1 Field Documentation
The information the sampler needs to provide at the time of sampling on the container label is:
 Sample identification
 Date and time
 Preservative
During the sampling process, the COC form is completed and must be legible. This form includes
information such as:
 Client name, address, phone number and fax number (if available)
 Project name and/or number
 The sample identification
 Date, time and location of sampling
 Sample collectors name
 The matrix description
 The container description
 The total number of each type of container
 Preservatives used
 Analysis requested
 Requested turnaround time (TAT)
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 Any special instructions
 Purchase Order number or billing information (e.g. quote number) if available
 The date and time that each person received or relinquished the sample(s), including their
signed name.
When the sampling personnel deliver the samples directly to the laboratory personnel, the
samples are stored in a cooler with ice, as applicable, and remain solely in the possession of the
client’s field technician until the samples are delivered to the laboratory personnel. The sample
collector must assure that each container is in his/her physical possession or in his/her view at all
times, or stored in such a place and manner to preclude tampering. The field technician
relinquishes the samples in writing on the COC form to the sample control personnel at the
laboratory or to a laboratory courier. When sampling personnel deliver the samples through a
common carrier (Fed-Ex, UPS), the CoC relinquished date/time is completed by the field
personnel and samples are released to the carrier. Samples are only considered to be received
by the laboratory when personnel at the fixed laboratory facility have physical contact with the
samples.
Note: Independent couriers are not required to sign the COC form. The COC is usually kept in
the sealed sample cooler. The receipt from the courier is stored in log-in by date; it lists all receipts
each date.
23.1.2 Legal / Evidentiary Chain-of-Custody
If samples are identified for legal/evidentiary purposes on the COC, login will retain the custody
seal and shipping record with the COC, and initiate an internal COC for use by analysts and a
sample disposal record.
23.2 Sample Receipt
Samples are received at the laboratory by designated sample receiving personnel and a unique
laboratory project identification number is assigned. Each sample container shall be assigned a
unique sample identification number that is cross-referenced to the client identification number
such that traceability of test samples is unambiguous and documented. Each sample container
is affixed with a durable sample identification label. Sample acceptance, receipt, tracking and
storage procedures are detailed in the laboratory’s SOP No. WS-QA-0003, “Sample Receipt and
Procedures” summarized in the following sections.
23.2.1 Laboratory Receipt
When samples arrive at the laboratory, sample receiving personnel inspect the coolers and
samples. The integrity of each sample must be determined by comparing sample labels or tags
with the COC and by visual checks of the container for possible damage. Any non-conformance,
irregularity, or compromised sample receipt must be documented on the lot receipt checklist and
within the non-conformance program and brought to the immediate attention of the client. The
COC, shipping documents, documentation of any non-conformance, irregularity, or compromised
sample receipt, record of client contact, and resulting instructions become part of the project
record. Laboratory receipt procedures are described in more detail in SOP No. WS-QA-0003.
Unique Sample Identification -
All samples that are processed through the laboratory receive a unique sample identification to ensure
that there can be no confusion regarding the identity of such samples at any time. This system includes
identification for all samples, subsamples and subsequent extracts and/or digestates.
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The laboratory assigns a unique identification (e.g., Sample ID) code to each sample container
received at the laboratory. This Primary ID is made up of the following information (consisting of 4
components):
Example: 320 - 9608 - A - 1

Location ID Login ID Container Code/Occurrence Sample
Number (320 for Sacramento)
The above example states the Eurofins Sacramento Location ID (Location 320), the Login ID (9608)
which is unique to a particular client/job occurrence, the container code (A) indicating the first container
and Sample Number (1).
If the primary container goes through a prep step that creates a “new” container, then the new container
is considered secondary and gets another ID. An example of this being a client sample in a 1-Liter
amber bottle is sent through a Liquid/Liquid Extraction and an extraction vial is created from this
step. The vial would be a SECONDARY container. The secondary ID has 5 components.
Example: 320 - 9608 - A - 1 - A Secondary Container Occurrence
Example: 320-9608-A-1-A, would indicate the PRIMARY container listed above that went through a
step that created the 1st occurrence of a Secondary container.
With this system, a client sample can literally be tracked throughout the laboratory in every step from
receipt to disposal.
23.3 Sample Acceptance Policy
The laboratory has a written sample acceptance policy (Figure 23-1) that clearly outlines the
circumstances under which samples shall be accepted or rejected. These include:
 a COC filled out completely;
 samples must be properly labeled;
 proper sample containers with adequate volume for the analysis (Sampling Guide) and
necessary QC;
 samples must be preserved according to the requirements of the requested analytical method
(Sampling Guide);
 sample holding times must be adhered to (Sampling Guide);
 the project manager will be notified if any sample is received in damaged condition.
Data from samples which do not meet these criteria are flagged and the nature of the variation
from policy is defined.
23.1.1 After inspecting the samples, the sample receiving personnel sign and date the COC form,
make any necessary notes of the samples' conditions and store them in appropriate refrigerators
or storage locations.
23.1.2 Any deviations from these checks that question the suitability of the sample for analysis,
or incomplete documentation as to the tests required will be resolved by consultation with the
client. If the sample acceptance policy criteria are not met, the laboratory shall either:
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 Retain all correspondence and/or records of communications with the client regarding the
disposition of rejected samples, or
 Fully document any decision to proceed with sample analysis that does not meet sample
acceptance criteria.
Note: North Carolina requires that they be notified when samples are
processed that do not meet sample acceptance criteria.

Once sample acceptance is verified, the samples are logged into the LIMS according SOP No.
WS-QA-0003.
23.4 Sample Storage
In order to avoid deterioration, contamination or damage to a sample during storage and handling,
from the time of receipt until all analyses are complete, samples are stored in refrigerators,
freezers or protected locations suitable for the sample matrix. In addition, samples to be analyzed
for volatile organic parameters are stored in separate refrigerators designated for volatile organic
parameters only. Samples are never to be stored with reagents, standards or materials that may
create contamination.
To ensure the integrity of the samples during storage, refrigerator blanks are maintained in the
volatile sample refrigerators and analyzed every two weeks.
Analysts and technicians retrieve the sample container allocated to their analysis from the
designated refrigerator and place them on carts, analyze the sample, and return the remaining
sample to the refrigerator from which it originally came. All unused portions of samples are
returned to the secure sample control area. Empty sample containers are marked as Destroyed
in the TALS sample check-in/check-out module and are disposed by the analytical staff. All
samples are kept in the refrigerators for 30 days past invoicing, unless other arrangements have
been made with the client.
Access to the laboratory is controlled such that sample storage need not be locked at all times
unless a project specifically demands it. Samples are accessible to laboratory personnel only.
Visitors to the laboratory are prohibited from entering the refrigerator and laboratory areas unless
accompanied by an employee of Eurofins Sacramento.
23.5 Hazardous Samples and Foreign Soils
To minimize risk, all soil samples are considered to be from USDA quarantine areas, and
materials used to process them are therefore treated in accordance with the laboratory’s USDA
Soil Permit Compliance agreement. This includes disposing of soil samples by sending them for
incineration by a USDA-approved waste disposal facility.
23.6 Sample Shipping
In the event that the laboratory needs to ship samples, the samples are placed in a cooler with
enough ice to ensure the samples remain just above freezing and at or below 6.0C during transit.
The samples are carefully surrounded by packing material to avoid breakage (yet mainta in
appropriate temperature). A trip blank is enclosed for those samples requiring water/solid volatile
organic analyses (see Note). The chain-of-custody form is signed by the sample control
technician and attached to the shipping paperwork. Samples are generally shipped overnight
express or hand-delivered by a Eurofins courier to maintain sample integrity. All personnel
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involved with shipping and receiving samples must be trained to maintain the proper chain-of-
custody documentation and to keep the samples intact and on ice. The Environmental, Health
and Safety Manual contains additional shipping requirements.
Note: If a client does not request trip blank analysis on the COC or other paperwork, the
laboratory will not analyze the trip blanks that were supplied. However, in the interest of good
client service, the laboratory will advise the client at the time of sample receipt that it was noted
that they did not request analysis of the trip blank; and that the laboratory is providing the
notification to verify that they are not inadvertently omitting a key part of regulatory compliance
testing.
23.7 Sample Disposal
Samples should be retained for a minimum of 30 days after the project report is sent, however,
provisions may be made for earlier disposal of samples once the holding time is exceeded. An
exception is samples contained in laboratory-owned air sample canisters. These are held for a
minimum of 24 hours after the project report is sent, prior to evacuating the canister and returning
it to the equipment pool. Some samples are required to be held for longer periods based on
regulatory or client requirements (e.g., 60 days after project report is sent). The laboratory must
follow the longer sample retention requirements where required by regulation or client agreement.
Several possibilities for sample disposal exist: the sample may be consumed completely during
analysis, the sample may be returned to the customer or location of sampling for disposal, or the
sample may be disposed of in accordance with the laboratory’s waste disposal procedures (SOP:
WS-EHS-001, “Waste Disposal”). All procedures in the laboratory’s Environmental, Health and
Safety Manual are followed during disposal. Samples are normally maintained in the laboratory
no longer than two months from receipt unless otherwise requested. Unused portions of samples
found or suspected to be hazardous according to state or federal guidelines may be returned to
the client upon completion of the analytical work.
If a sample is part of a known litigation, the affected legal authority, sample data user, and/or
submitter of the sample must participate in the decision about the sample’s disposal. All
documentation and correspondence concerning the disposal decision process must be kept on
file. Pertinent information includes the date of disposal, nature of disposal (such as sample
depletion, hazardous waste facility disposal, and return to client), names of individuals who
conducted the arrangements and physically completed the task. The laboratory will remove or
deface sample labels prior to disposal unless this is accomplished through the disposal method
(e.g., samples are incinerated). A Waste Disposal Record should be completed.

Figure 23-1. Example: Sample Acceptance Policy

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24.0 ASSURING THE QUALITY OF TEST RESULTS
24.1 Overview
In order to assure our clients of the validity of their data, the laboratory continuously evaluates the
quality of the analytical process. The analytical process is controlled not only by instrument
calibration as discussed in Section 20, but also by routine process quality control measurements
(e.g. Blanks, Laboratory Control Samples (LCS), Matrix Spikes (MS), duplicates (DUP),
surrogates, Internal Standards (IS)). These quality control checks are performed as required by
the method or regulations to assess precision and accuracy. Quality control samples are to be
treated in the exact same manner as the associated field samples being tested. In addition to the
routine process quality control samples, Proficiency Testing (PT) Samples (concentrations
unknown to laboratory) are analyzed to help ensure laboratory performance.
24.2 Controls
Sample preparation or pre-treatment is commonly required before analysis. Typical preparation
steps include homogenization, grinding, solvent extraction, sonication, acid digestion, reflux,
evaporation, and drying. During these pre-treatment steps, samples are arranged into discrete
manageable groups referred to as preparation (prep) batches. Prep batches provide a means to
control variability in sample treatment. Control samples are added to each prep batch to monitor
method performance and are processed through the entire analytical procedure with
investigative/field samples.
24.3 Negative Controls
Table 24-1. Example – Negative Controls
Control Type Details
Method Blanks
(MB)
are used to assess preparation and analysis for possible contamination during the preparation
and processing steps.
The specific frequency of use for method blanks during the analytical sequence is defined in the
specific standard operating procedure for each analysis. Generally it is 1 for each batch of
samples; not to exceed 20 environmental samples.
The method blank is prepared from a clean matrix similar to that of the associated samples that
is free from target analytes (e.g., Reagent water, Ottawa sand, glass beads, etc.) and is
processed along with and under the same conditions as the associated samples.
The method blank goes through all of the steps of the process (including as necessary: filtration,
clean-ups, etc.).
Reanalyze or qualify associated sample results when the concentration of a targeted analyte in
the blank is at or above the reporting limit as established by the method or by regulation, AND is
greater than 1/10 of the amount measured in the sample.
Calibration
Blanks
are prepared and analyzed along with calibration standards where applicable. They are
prepared using the same reagents that are used to prepare the standards. In some analyses the
calibration blank may be included in the calibration curve.
Instrument Blanks are blank reagents or reagent water that may be processed during an analytical sequence in
order to assess contamination in the analytical system. In general, instrument blanks are used to
differentiate between contamination caused by the analytical system and that caused by the
sample handling or sample prep process. Instrument blanks may also be inserted throughout the
analytical sequence to minimize the effect of carryover from samples with high analyte content.
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Table 24-1. Example – Negative Controls
Control Type Details
Trip Blank 1 are required to be submitted by the client with each shipment of samples requiring aqueous and
solid volatiles analyses (or as specified in the client’s project plan). A trip blank may be
purchased (certified clean) or is prepared by the laboratory by filling a clean container with pure
deionized water that has been purged to remove any volatile compounds. Appropriate
preservatives are also added to the container. The trip blank is sent with the bottle order and is
intended to reflect the environment that the containers are subjected to throughout shipping and
handling and help identify possible sources if contamination is found. The field sampler returns
the trip blank in the cooler with the field samples.
Field Blanks 1 are sometimes used for specific projects by the field samplers. A field blank prepared in the field
by filling a clean container with pure reagent water and appropriate preservative, if any, for the
specific sampling activity being undertaken. (EPA OSWER)
Equipment
Blanks 1
are also sometimes created in the field for specific projects. An equipment blank is a sample of
analyte-free media which has been used to rinse common sampling equipment to check
effectiveness of decontamination procedures. (TNI)
Holding Blanks also referred to as refrigerator or freezer blanks, are used to monitor the sample storage units for
volatile organic compounds during the storage of VOA samples in the laboratory
1 When known, these field QC samples should not be selected for matrix QC as it does not provide
information on the behavior of the target compounds in the field samples. Usually, the client sample ID will
provide information to identify the field blanks with labels such as "FB", "EB", or "TB."
Evaluation criteria and corrective action for these controls are defined in the specific standard
operating procedure for each analysis.
24.4 Positive Controls
Control samples (e.g., QC indicators) are analyzed with each batch of samples to evaluate data
based upon (1) Method Performance (Laboratory Control Sample (LCS) or Blank Spike (BS)),
which entails both the preparation and measurement steps; and (2) Matrix Effects (Matrix Spike
(MS) (Matrix spikes are not applicable to air) or Sample Duplicate (MD, DUP), which evaluates
field sampling accuracy, precision, representativeness, interferences, and the effect of the matrix
on the method performed. Each regulatory program and each method within those programs
specify the control samples that are prepared and/or analyzed with a specific batch
Note that frequency of control samples vary with specific regulatory, methodology and project
specific criteria. Complete details on method control samples are as listed in each analytical SOP.
24.4.1 Method Performance Control - Laboratory Control Sample (LCS)
The LCS measures the accuracy of the method in a blank matrix and assesses method
performance independent of potential field sample matrix affects in a laboratory batch.
The LCS is prepared from a clean matrix similar to that of the associated samples that is free from
target analytes (for example: Reagent water, Ottawa sand, glass beads, etc.) and is processed
along with and under the same conditions as the associated samples. The LCS is spiked with
verified known amounts of analytes or is made of a material containing known and verified
amounts of analytes, taken through all preparation and analysis steps along with the field
samples. Where there is no preparation taken for an analysis (such as in aqueous volatiles), or
when all samples and standards undergo the same preparation and analysis process, a
calibration verification standard is reported as the LCS. In some instances where there is no
practical clean solid matrix available, aqueous LCS’s may be processed for solid matrices; final
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results may be calculated as mg/kg or ug/kg, assuming 100% solids and a weight equivalent to the
aliquot used for the corresponding field samples, to facilitate comparison with the field samples.
Certified pre-made reference material purchased from a NIST/ISO 17025 accredited vendor may
also be used for the LCS when the material represents the sample matrix or the analyte is not
easily spiked (e.g. solid matrix LCS for metals, TDS, etc.).
The specific frequency of use for LCS during the analytical sequence is defined in the specific
standard operating procedure for each analysis. It is generally 1 for each batch of samples; not
to exceed 20 environmental samples.
If the mandated or requested test method, or project requirements, do not specify the spiking
components, the laboratory shall spike all reportable components to be reported in the Laboratory
Control Sample (and Matrix Spike) where applicable (e.g. no spike of pH). However, in cases
where the components interfere with accurate assessment (such as simultaneously spiking
chlordane, toxaphene and Pesticides in Method 8081B), the test method has an extremely long
list of components or components are incompatible, at a minimum, a representative number of
the listed components (see below) shall be used to control the test method. The selected
components of each spiking mix shall represent all chemistries, elution patterns and masses,
permit specified analytes and other client requested components. However, the laboratory shall
ensure that all reported components are used in the spike mixture within a two-year time period.
 For methods that have 1-10 target analytes, spike all components.
 For methods that include 11-20 target analytes, spike at least 10 or 80%, whichever is greater.
 For methods with more than 20 target analytes, spike at least 16 components.
 Exception: Due to analyte incompatibility in pesticides, Toxaphene and Chlordane are only
spiked at client request based on specific project needs.
 Exception: Due to analyte incompatibility between the various PCB Aroclors, Aroclors 1016
and 1260 are used for spiking as they cover the range of all of the Aroclors. Specific Aroclors
may be used by request on a project specific basis.
24.5 Sample Matrix Controls
Table 24-5. Sample Matrix Control
Control
Type
Details
Matrix Spikes
(MS)
Use used to assess the effect sample matrix of the spiked sample has on the precision and
accuracy of the results generated by the method used;
Typical
Frequency 1
At a minimum, with each matrix-specific batch of samples processed, an MS is carried
through the complete analytical procedure. Unless specified by the client, samples used
for spiking are randomly selected and rotated between different client projects. If the
mandated or requested test method does not specify the spiking components, the
laboratory shall spike all reportable components to be reported in the Laboratory Control
Sample and Matrix Spike. Refer to the method SOP for complete details
Description Essentially a sample fortified with a known amount of the test analyte(s).
Surrogate Use Measures method performance to sample matrix (organics only).
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Table 24-5. Sample Matrix Control
Control
Type
Details
Typical
Frequency 1
Are added to all samples, standards, and blanks, for all organic chromatography
methods except when the matrix precludes its use or when a surrogate is not available.
The recovery of the surrogates is compared to the acceptance limits for the specific
method. Poor surrogate recovery may indicate a problem with sample composition and
shall be reported, with data qualifiers, to the client whose sample produced poor
recovery.
Description Are similar to matrix spikes except the analytes are compounds with properties that
mimic the analyte of interest and are unlikely to be found in environment samples.
Duplicates2 Use For a measure of analytical precision, with each matrix-specific batch of samples
processed, a matrix duplicate (MD or DUP) sample, matrix spike duplicate (MSD), or
LCS duplicate (LCSD) is carried through the complete analytical procedure.
Typical
Frequency 1
Duplicate samples are usually analyzed with methods that do not require matrix spike
analysis.
Description Performed by analyzing two aliquots of the same field sample independently or an
additional LCS.
Internal
Standards
Use Are spiked into all environmental and quality control samples (including the initial
calibration standards) to monitor the qualitative aspect of organic and some inorganic
analytical measurements.
Typical
Frequency 1
All organic and ICP methods as required by the analytical method.
Description Used to correct for matrix effects and to help troubleshoot variability in analytical response
and are assessed after data acquisition. Possible sources of poor internal standard
response are sample matrix, poor analytical technique or instrument performance.

1 See the specific analytical SOP for type and frequency of sample matrix control samples.
2 LCSD’s are normally not performed except when regulatory agencies or client specif ications require them. The
recoveries for the spiked duplicate samples must meet the same laboratory established recovery limits as the accuracy
QC samples. If an LCSD is analyzed both the LCS and LCSD must meet the same recovery criteria and be included
in the final report. The precision measurement is reported as “Relative Percent Difference” (RPD). Poor precision
between duplicates (except LCS/LCSD) may indicate non-homogeneous matrix or sampling.

24.6 Acceptance Criteria (Control Limits)
As mandated by the test method and regulation, each individual analyte in the LCS, MS, or
Surrogate Spike is evaluated against the control limits published in the test method. Where there
are no established acceptance criteria, the laboratory calculates in-house control limits with the
use of control charts or, in some cases, utilizes client project specific control limits. When this
occurs, the regulatory or project limits will supersede the laboratory’s in-house limits.
Note: For methods, analytes and matrices with very limited data (e.g., unusual matrices not
analyzed often), interim limits are established using available data or by analogy to similar
methods or matrices.
Once control limits have been established, they are verified, reviewed, and updated if necessary
on an annual basis unless the method requires more frequent updating. Control limits are
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established per method (as opposed to per instrument) regardless of the number of instruments
utilized.
Laboratory generated % Recovery acceptance (control) limits are generally established by taking
± 3 Standard Deviations (99% confidence level) from the average recovery of a minimum of 30
data points (more points are preferred.
 Regardless of the calculated limit, the limit should be no tighter than the Calibration
Verification (ICV/CCV). (Unless the analytical method specifies a tighter limit).
 In-house limits cannot be any wider than those mandated in a regulated analytical method.
Client or contract required control limits are evaluated against the laboratory’s statistically
derived control limits to determine if the data quality objectives (DQOs) can be achieved. If
laboratory control limits are not consistent with DQOs, then alternatives must be considered,
such as method improvements or use of an alternate analytical method.
 The lowest acceptable recovery limit will be 10% (the analyte must be detectable and
identifiable). Exception: The lowest acceptable recovery limit for Benzidine will be 5% and
the analyte must be detectable and identifiable.
 The maximum acceptable recovery limit will be 150%. Some specific methods or SOPs may
allow for higher recoveries.
 The maximum acceptable RPD limit will be 35% for waters and 40% for soils. The minimum
RPD limit is 10%.
 If either the high or low end of the control limit changes by ≤ 5% from previous, the control
chart is visually inspected and, using professional judgment, they may be left unchanged if
there is no affect on laboratory ability to meet the existing limits.
24.6.1 The lab must be able to generate a current listing of their control limits and track when the
updates are performed. In addition, the laboratory must be able to recreate historical control
limits. See SOP WS-QA-0035 for further details.
24.6.2 A LCS that is within the acceptance criteria establishes that the analytical system is in
control and is used to validate the process. Samples that are analyzed with an LCS with
recoveries outside of the acceptance limits may be determined as out of control and should be
reanalyzed if possible. If reanalysis is not possible, then the results for all affected analytes for
samples within the same batch must be qualified when reported. The internal corrective action
process (see Section 12) is also initiated if an LCS exceeds the acceptance limits. Sample results
may be qualified and reported without reanalysis if:
 The analyte results are below the reporting limit and the LCS is above the upper control limit.
 If the analytical results are above the relevant regulatory limit and the LCS is below the lower
control limit.
Or, for TNI and DoD/DOE work, there are an allowable number of Marginal Exceedances (ME):
<11 analytes 0 marginal exceedances are allowed.
11 – 30 Analytes 1 marginal exceedance is allowed
31-50 Analytes 2 marginal exceedances are allowed
51-70 Analytes 3 marginal exceedances are allowed
71-90 Analytes 4 marginal exceedances are allowed
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> 90 Analytes 5 marginal exceedances are allowed
 Marginal exceedances are recovery exceedances between 3 SD and 4 SD from the mean
recovery limit (TNI).
 Marginal exceedances must be random. If the same analyte exceeds the LCS control limit
repeatedly, it is an indication of a systematic problem. The source of the error must be
located and corrective action taken. The laboratory has a system to monitor m arginal
exceedances to ensure that they are random.
Though marginal exceedances may be allowed, the data must still be qualified to indicate it is
outside of the normal limits.
24.6.3 If the MS/MSDs do not meet acceptance limits, the MS/MSD and the associated spiked
sample is reported with a qualifier for those analytes that do not meet limits. If obvious preparation
errors are suspected, or if requested by the client, unacceptable MS/MSDs are reprocessed and
reanalyzed to prove matrix interference. A more detailed discussion of acceptance criteria and
corrective action can be found in the lab’s method SOPs and in Section 12.
24.6.4 If a surrogate standard falls outside the acceptance limits, if there is not obvious
chromatographic matrix interference, reanalyze the sample to confirm a possible matrix effect. If
the recoveries confirm or there was obvious chromatographic interference, results are reported
from the original analysis and a qualifier is added. If the reanalysis meets surrogate recovery
criteria, the second run is reported (or both are reported if requested by the client). Under certain
circumstances, where all of the samples are from the same location and share similar
chromatography, the reanalysis may be performed on a single sample rather than all of the
samples and if the surrogate meets the recovery criteria in the reanalysis, all of the affected
samples would require reanalysis.
24.7 Additional Procedures to Assure Quality Control
The laboratory has written and approved method SOPs to assure the accuracy of the test method
including calibration (see Section 20), use of certified reference materials (see Section 21) and
use of PT samples (see Section 17).
A discussion regarding MDLs, Limit of Detection (LOD) and Limit of Quantita tion (LOQ) can be
found in Section 19.
 Use of formulae to reduce data is discussed in the method SOPs and in Section 20.
 Selection of appropriate reagents and standards is included in Section 11 and 21.
 A discussion on selectivity of the test is included in Section 7.
 Constant and consistent test conditions are discussed in Section 6.
 The laboratories sample acceptance policy is included in Section 23.
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25.0 REPORTING RESULTS
25.1 Overview
The results of each test are reported accurately, clearly, unambiguously, and objectively in
accordance with State and Federal regulations as well as client requirements. Analytical results
are issued in a format that is intended to satisfy customer and laboratory accreditation
requirements as well as provide the end user with the information needed to properly evaluate
the results. Where there is conflict between client requests and laboratory ethics or regulatory
requirements, the laboratory’s ethical and legal requirements are paramount, and the laboratory
will work with the client during project set up to develop an acceptable solution. Refer to Section
9.
A variety of report formats are available to meet specific needs.
In cases where a client asks for simplified reports, there must be a written request from the client.
There still must be enough information that would show any analyses that were out of
conformance (QC out of limits) and there should be a reference to a full report that is made
available to the client. Review of reported data is included in Section 19.
25.2 Test Reports
Analytical results are reported in a format that is satisfactory to the client and meets all
requirements of applicable accrediting authorities and agencies. A variety of report formats are
available to meet specific needs. The report is printed on laboratory letterhead, reviewed, and
signed by the appropriate project manager. At a minimum, the standard laboratory report shall
contain the following information:
25.2.1 A report title (e.g., Analytical Report)
25.2.2 The cover page shall include the laboratory name, address and telephone number.
25.2.3 A unique identification of the report (e.g., Eurofins Sacramento Job ID #) and on each
page an identification in order to ensure the page is recognized as part of the report and a clear
identification of the end.
Note: Page numbers of report are represented as page # of ##. Where the first number is
the page number and the second is the total number of pages.
25.2.4 A copy of the chain of custody (COC).
 Any COCs involved with Subcontracting are included.
25.2.5 The name and address of client and a project name/number, if applicable.
25.2.6 Client project manager or other contact
25.2.7 Description and unambiguous identification of the tested sample(s) including the client
identification code.
25.2.8 Date of receipt of sample, date and time of collection, and date(s) of test preparation
and performance, and time of preparation or analysis if the required holding time for either activity
is less than or equal to 72 hours.
25.2.9 Date reported or date of revision, if applicable.
25.2.10 Method of analysis including method code (EPA, Standard Methods, etc.).
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25.2.11 Reporting limit.
25.2.12 Method detection limits (if requested)
25.2.13 Definition of Data qualifiers and reporting acronyms (e.g. ND).
25.2.14 Sample results.
25.2.15 QC data consisting of method blank, surrogate, LCS, and MS/MSD recoveries and
control limits.
25.2.16 Condition of samples at receipt including temperature. This may be accomplished in
a narrative or by attaching sample login sheets (Refer to Sec. 25.2.4 – Item 3 regarding additional
addenda).
25.2.17 A statement expressing the validity of the results, that the source methodology was
followed and all results were reviewed for error.
25.2.18 A statement to the effect that the results relate only to the items tested and the sample
as received by the laboratory, except when information is provided by the client. When data is
provided by the client there shall be a clear identification of it, and a disclaimer shall be put in the
report when the client supplied data can affect the validity of the test.
25.2.19 A statement that the report shall not be reproduced except in full, without prior express
written approval by the laboratory.
25.2.20 A signature and title of the person(s) accepting responsibility for the content of the
report and date of issue. Authorized signatories are qualified Project Managers appointed by the
Customer Service Manager.
25.2.21 When TNI accreditation is required, the lab shall certify that the test results meet all
requirements of TNI or provide reasons and/or justification if they do not.
25.2.22 The laboratory includes a cover letter.
25.2.23 Where applicable, a narrative to the report that explains the issue(s) and corrective
action(s) taken in the event that a specific accreditation or certif ication requirement was not met.
25.2.24 When soil samples are analyzed, a specific identif ication as to whether soils are
reported on a “wet weight” or “dry weight” basis.
25.2.25 Appropriate laboratory certification number for the state of origin of the sample, if
applicable.
25.2.26 If only part of the report is provided to the client (client requests some results before
all of it is complete), it must be clearly indicated on the report (e.g., partial report, or how your lab
identifies it). A complete report must be sent once all of the work has been completed.
25.2.27 Any analytical results generated by an external laboratory are clearly identified in the
final report. Analytical results generated by a laboratory using the EET LIMS are provided in a
single report in which the laboratory associated with each specific test is clearly identified. Reports
from external laboratories not on the EET LIMS system are provided in their entirety as an
attachment to the EET final report.
25.2.28 A Certification Summary Report, where required, will document that, unless otherwise
noted, all analytes tested and reported by the laboratory were covered by the noted certifications.
Note: Refer to the NDSC Document No. NDSC-US-IT-QP46227, Electronic Reporting and
Signature Policy, for details on internally applying electronic signatures of approval.
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25.2.29 Reports for Ohio VAP work require a VAP affidavit be completed and included with the
report.
25.2.30 Where the laboratory is responsible for the sampling stage, in addition to the
requirements listed above, reports containing the results of sampling shall include the following,
where necessary for the interpretation of test results:
 the date of sampling;
 unambiguous identification of the material sampled;
 the location of sampling plan and procedures, and deviations, addition to or exclusions from
the sample procedures;
 a reference to the sampling plan and procedure, and deviations, additions to or exclusions
from the sample procedures;
 details of any environmental conditions during sampling that affect the interpretation of test
results;
 information required to evaluate measurement uncertainty for subsequent testing
25.3 Reporting Level or Report Type
The laboratory offers four levels of quality control reporting. Each level, in a ddition to its own
specific requirements, contains all the information provided in the preceding level. The packages
provide the following information in addition to the information described above:
 Level 1 is a report with all of the elements outlined in Section 25.2 above, excluding 25.2.15
(QC data).
 Level II is a Level I report plus summary information, including results for the method blank
reported to the laboratory MDL, percent recovery for laboratory control samples and matrix
spike samples, and the RPD values for all MSD and sample duplicate analyses.
 Level III contains all the information supplied in Level II, but presented on the CLP-like
summary forms, and relevant calibration information. A Level II report is not included, unless
specifically requested. No raw data is provided.
 Level IV is the same as Level III with the addition of all raw supporting data.
In addition to the various levels of QC packaging, the laboratory also provides reports in EDD
(see below). Initial reports may be provided to clients by facsimile. Procedures used to ensure
client confidentiality are outlined in Section 25.6.
25.4 Electronic Data Deliverables (EDDs)
EDDs are routinely offered as part of Eurofins Sacramento’s services in addition to the test report
as described in Section 25.2. When NELAP accreditation is required and both a test report and
EDD are provided to the client, the official version of the test report will be the combined
information of the report and the EDD. The Sacramento laboratory offers a variety of EDD formats
including Environmental Restoration Information Management System (ERPIMS), New Agency
Standard (NAS), Format A, Excel, Dbase, GISKEY, Text Files, Staged Electronic Data
Deliverable (SEDD) Environmental Quality Information System (EQuIS), Electronic Deliverable
Format (EDF), Excel and custom files.
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EDD specifications are submitted to the IT department by the PM for review and undergo the
contract review process. Once the facility has committed to providing data in a specific electronic
format, the coding of the format may need to be performed. This coding is documented and
validated. The validation of the code is retained by the IT staff coding the EDD, and a copy filed
on the QA share of the local server.
EDDs shall be subject to a review to ensure their accuracy and completeness. If EDD generation
is automated, review may be reduced to periodic screening if the laboratory can demonstrate that
it can routinely generate that EDD without errors. Any revisions to the EDD format must be
reviewed until it is demonstrated that it can routinely be generated without errors. If the EDD can
be reproduced accurately and if all subsequent EDDs can be produced error-free, each EDD does
not necessarily require a review.
25.5 Supplemental Information for Test
The lab identifies any unacceptable QC analyses or any other unusual circumstances or
observations such as environmental conditions and any non-standard conditions that may have
affected the quality of a result. This is typically in the form of a footnote or a qualifier and/or a
narrative explaining the discrepancy in the front of the report.
Numeric results with values outside of the calibration range, either high or low are qualified as
estimated.
Where quality system requirements are not met, a statement of compliance/non-compliance with
requirements and/or specifications is required, including identification of test results derived from
any sample that did not meet TNI sample acceptance requirements such as improper container,
holding time, or temperature.
Where applicable, a statement on the estimated uncertainty of measurements; information on
uncertainty is needed when a client’s instructions so require.
When, as requested by the client and agreed to by Eurofins Sacramento, the report includes a
statement of conformity to specification or standard (see Special Services, Section 7.4), the report
shall clearly identify:
 to which results the statement applies,
 which specifications, standard or parts thereof are met or not, and
 the decision rule that was applied (unless the decision rule is inherent in the requested
specification or standard, taking into account the level of risk (such as false accept and false
reject and statistical assumptions) associated with the decision rule.
Opinions and Interpretations - The test report contains objective information, and generally does
not contain subjective information such as opinions and interpretations. If such information is
required by the client, the Laboratory Director will determine if a response can be prepared. If so,
the Laboratory Director will designate the appropriate member of the management team to
prepare a response. The response will be fully documented, and reviewed by the Laboratory
Director, before release to the client. There may be additional fees charged to the client at this
time, as this is a non-routine function of the laboratory.
Note: Review of data deliverable packages for submittal to regulatory authorities requires
responses to non-conforming data concerning potential impact on data quality. This necessitates
a limited scope of interpretation, and this work is performed by the QA Department. This is the
only form of “interpretation” of data that is routinely performed by the laboratory.
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When opinions or interpretations are included in the report, the laboratory provides an explanation
as to the basis upon which the opinions and interpretations have been made. Opinions and
interpretations are clearly noted as such and where applicable, a comment should be added
suggesting that the client verify the opinion or interpretation with their regulator.
25.6 Environmental Testing Obtained From Subcontractors
If the laboratory is not able to provide the client the requested analysis, the samples would be
subcontracted following the procedures outlined in the NDSC Document No. NDSC-US-SUB-
SOP44936, Subcontracting.
Data reported from analyses performed by a subcontractor laboratory are clearly identified as
such on the analytical report provided to the client. Results from a subcontract laboratory outside
of the EET network, or laboratories within the EET network that do not share the Eurofins LIMS
are reported to the client on the subcontract laboratory’s original report stationary and the report
includes any accompanying documentation. Test results from a laboratory within the EET
network sharing the Eurofins LIMS are noted within the Eurofins LIMS-generated report.
25.7 Client Confidentiality
The laboratory will ensure the highest standards of quality and integrity of the data and services
provided to our clients.
The laboratory is responsible for maintaining in confidence all client information obtained or
created. In situations involving the transmission of environmental test results by telephone,
facsimile or other electronic means, client confidentiality must be maintained.
The laboratory will not intentionally divulge to any person (other than the client or any other person
designated by the client in writing) any information regarding the services provided by the
laboratory or any information disclosed to the laboratory by the client. Furthermore, information
known to be potentially endangering to national security or an entity’s proprietary rights will not
be released.
Information about the client obtained from sources other than the client (e.g., complainant,
regulators) shall be confidential between client and the laboratory. The source of this information
shall be confidential to the laboratory and shall not be shared with the client, unless agreed by
the source.
Note: This shall not apply to the extent that the information is required to be disclosed by the
laboratory under the compulsion of legal process. The laboratory will, to the extent feasible,
provide reasonable notice to the client before disclosing the information.
Note: Authorized representatives of an accrediting authority are permitted to make copies of
any analyses or records relevant to the accreditation process, and copies may be removed from
the laboratory for purposes of assessment.
25.7.1 Report deliverable formats are discussed with each new client. If a client requests that
reports be e-mailed, the reports are to meet all requirements of this document.
25.8 Format of Reports
The format of reports is designed to accommodate each type of environmental test carried out
and to minimize the possibility of misunderstanding or misuse.
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25.9 Amendments to Test Reports
Corrections, additions, or deletions to reports are only made when justif ication arises through
supplemental documentation. Justification is documented using the laboratory’s corrective action
system (refer to Section 12).
The revised report is retained on in the LIMS, as is the original report. The revised report is stored
in the Archive data server under the report number followed by Rev (x) where the x represents
the revision number. The original version does not have a revision number. The revised report
will have the notation “Revision X” under the client project description on the cover page, and
“Rev. x” next to the date in the footer of subsequent pages.
When the report is re-issued, a notation of “report re-issue“ is placed on the cover/signature page
of the report or at the top of the narrative page with a brief explanation of reason for the re-issue
and a reference back to the last final report generated. For Example: Report was revised on
3/8/20 to include toluene in sample NQA1504 per client’s request. This final report replaces the
final report generated on 1/27/20 at 10:47am.
25.10 Policies on Client Requests for Amendments
25.10.1 Policy on Data Omissions or Reporting Limit Increases
Fundamentally, our policy is simply to not omit previously reported results (including data
qualifiers) or to not raise reporting limits and report sample results as ND. This policy has few
exceptions. Exceptions are:
 Laboratory error.
 Sample identification is indeterminate (confusion between COC and sample labels).
 An incorrect analysis (not analyte) was requested (e.g., COC lists 8315 but client wanted
8310). A written request for the change is required.
 Incorrect limits reported based on regulatory requirements.
 The requested change has absolutely no possible impact on the interpretation of the analytical
results and there is no possibility of the change being interpreted as misrepresentation by
anyone inside or outside of our company.
25.10.2 Multiple Reports
The laboratory does not issue multiple reports for the same work order where there is different
information on each report (this does not refer to copies of the same report) unless required to
meet regulatory needs and approved by QA.

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Appendix 1. List of Governing Documents applicable to the QA Manual

NDSC Doc. No. Title
NDSC-US-IT-QP46227 Electronic Reporting and Signature Policy
NDSC-QA-SOP46704 Acid and Solvent Testing and Approval Program
NDSC-QA-SOP43862 Manual Integrations
NDSC-QA-SOP42091 Detection and Quantitation Limits
NDSC-QA-SOP43847 Root Cause Analysis
NDSC-US EHS-46060 Environmental Health & Safety Manual
NDSC-US-IT-QP46202 IT Change Control Procedure Manual
CW -L-P-001 Records Retention Policy
SOP01-QA-QP5252 Ethics and Data Integrity Policy
QA-SOP38228 Internal Investigation
NDSC-US-SUB-SOP44936 Subcontracting
NDSC-QA-SOP5260 Internal Auditing
QA-QP38702 Management Systems Review
QA-SOP38229 Nonconforming Work
Local Laboratory Document
No.
Title
WS-EHS-0001 Waste Disposal
WS-PEHS-002 Sacramento Addendum to Environmental Health and Safety
Manual
WS-PM-0001 Final Report Assembly and Third Level Data Review
WS-PM-0003 Program Setup and Distillation
WS-PQA-003 Quality Control Program
WS-PQA-012 Technical Data Review Requirements
WS-PQA-013 Procedures to Address Customer Complaints
WS-PQA-017 Electronic Reporting and Client Deliverables
WS-PQA-018 Quality Assurance Project Plan (QAPP) Review
WS-PQA-021 Federal Program Requirements
WS-QA-0003 Sample Receipt and Procedures
WS-QA-0004 Maintenance and Calibration Check of Fixed and Adjustable
Volume Autopipettors, Autodispensers and Volumetric Containers
WS-QA-0005 Temperature Monitoring and Corrective Action for Freezers
WS-QA-0006 Method Detection Limits (MDL) and Instrument Detection Limits
(IDL)
WS-QA-0009 Document Archiving
WS-QA-0016 Thermometer Calibration
WS-QA-0017 Standards and Reagents and Quality Control Check Procedures
WS-QA-0018 Subsampling and Compositing of Samples
WS-QA-0021 Preparation and Management of Standard Operating Procedures
WS-QA-0022 Employee Orientation and Training
WS-QA-0023 Non-Conformance and Corrective Action System
WS-QA-0024 QA Data Review
WS-QA-0028 Incremental Sampling Methodology of Soils and Sediments
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WS-QA_0031 Verification and Security of Spreadsheet Applications
WS-QA-0035 Statistical Process Control / Control Chart
WS-QA-0041 Calibration and Calibration Check of Balances

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Appendix 2. List of Laboratory Certifications, Accreditations, Validations

The laboratory maintains accreditations, certifications, and approvals with numerous state and
national entities. Programs vary but may include on-site audits, reciprocal agreements with
another entity, performance testing evaluations, review of the QA Manual, Standard Operating
Procedures, Method Detection Limits, training records, etc. At the time of this QA Manual revision,
the laboratory has accreditation/ certification/licensing with the following organizations:
Program Authority Identification Expiration Date
Dept. of Defense ELAP ANAB L2468 01/20/2024
Dept. of Energy ANAB L2468.01 01/20/2024
ISO/IEC 17025 ANAB L2468 01/20/2024
NELAP Florida E87570 06/30/2023
NELAP Illinois 200060 03/17/2024
NELAP Kansas E-10375 10/31/2022
NELAP Louisiana 01944 06/30/2023
NELAP Louisiana (All) 01944 06/30/2023
NELAP New Hampshire 2997 04/18/2023
NELAP New Jersey CA005 06/30/2023
NELAP New York 11666 04/01/2023
NELAP Oregon 4040 01/29/2023
NELAP Texas T104704399-19-13 05/31/2023
NELAP Utah CA000442021-12 02/28/2023
NELAP Virginia 460278 03/14/2023
State Alaska (UST) 17-020 02/20/2024
State Arizona AZ0708 08/11/2023
State Arkansas DEQ 88-0691 06/17/2022 *
State California 2897 01/31/2023
State Colorado CA0004 08/31/2023
State Georgia 4040 01/30/2023
State Hawaii NA 01/29/2023
State Maine CA00004 04/14/2024
State Michigan 9947 01/31/2023
State Nevada CA00044 07/31/2023
State Ohio 41252 01/29/2023
State Washington C581 05/05/2023
State West Virginia (DW) 9930C 12/31/2022
State Wisconsin 998204680 08/31/2023

* Certification Valid - Laboratory is Pending Renewal with the Program Authority. Current
certificates and accredited parameter lists are available for each State/Program organization from
the laboratory on request.
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Appendix 3. References used to prepare the QA Manual
The QAM has been prepared to be consistent with the requirements of the following documents:
 ANSI/ASQC, E4-1994, “Specifications and Guidelines for Quality Management Systems for
Environmental Data Collection and Environmental Technology Programs” (Americ an National
Standard, January 5, 1995, or most recent version)
 “EPA Requirements for Quality Management Programs” (QA/R-2) (EPA/240/B-01/002, May 31, 2006).
 EPA 600/4-88/039, Methods for the Determination of Organic Compounds in Drinking Water, EPA,
Revised July 1991.
 EPA 600/R-95/131, Methods for the Determination of Organic Compounds in Drinking Water,
Supplement III, EPA, August 1995.
 EPA 600/4-79-019, Handbook for Analytical Quality Control in Water and Wastewater Laboratories,
EPA, March 1979.
 Test Methods for Evaluating Solid Waste Physical/Chemical Methods (SW846), Third Edition,
September 1986, Final Update I, July 1992, Final Update IIA, August 1993, Final Update II, September
1994; Final Update IIB, January 1995; Final Update III, December 1996; Final Update IV, January 2008;
Final Update V, August 2015; Final Update VI, June 2018; Final Update VII, July 2021
 U.S. Department of Defense (DoD)/Department of Energy (DOE) Consolidated Quality Systems
Manual (QSM) for Environmental Laboratories, Version 5.4, dated 2021
 Federal Register, 40 CFR Parts 136, 141, 172, 173, 178, 179 and 261.
 Manual for the Certification of Laboratories Analyzing Drinking Water (EPA 815-R-05-004, January
2005) (DW labs only)
 Statement of Work for Inorganics & Organics Analysis, SOM and ISM, current versions, USEPA
Contract Laboratory Program Multi-media, Multi-concentration.
 APHA, Standard Methods for the Examination of Water and Wastewater, 18th Edition, 19th, 20th, 21st,
22nd and on-line Editions.
 U.S. Department of Energy Order 414.1B, Quality Assurance, Approved April 29, 2004.
 U.S. Department of Energy Order 414.1C, Quality Assurance, June 17, 2005.
 U.S. Department of Energy Order 414.1D, Quality Assurance, April, 25, 2011.
 Nuclear Regulatory Commission (NRC) Quality Assurance Requirements.
 Marine Protection, Research, and Sanctuaries Act (MPRSA).
 Toxic Substances Control Act (TSCA).

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Appendix 4. QA Manual Crosswalk with TNI and ISO/IEC 17025 Standards

Sec.
No. Title
2009 and 2016
TNI Standard
Reference
ISO/IEC
17025:2005(E)
Reference
ISO/IEC
17025:2017(E)
Reference
- Quality Assurance Manual Cover Page V1M2 Sec. 4.2.8.3
1.0 Title Page
2.0 Table of Contents V1M2 Secs. 4.2.8.3-
4.2.8.4
8.1.2, 8.2.1
3.0 Introduction, Scope and Applicability V1M2 Sec. 4.2.8.4
3.1 Introduction and Compliance References V1M2 Secs. 1.1; 1.2;
2.0; 3.2; 4.1.2; 4.2.4
4.1.2; 4.2.4 5.3; 5.4;
8.2.4; 8.3.1
3.2 Terms and Definitions V1M2 Secs. 3.0;
4.2.4
4.2.4
3.3 Scope /Field of Testing V1M2 Secs. 1.2;
4.2.4
4.1.2; 4.2.4 5.3; 5.4;
8.2.1; 8.2.4
3.4 Management of The Manual
V1M2 Secs. 4.2.1;
4.2.7; 4.3.3.2;
4.3.3.3
4.2.1; 4.2.7;
4.3.3.2; 4.3.3.3
5.3
4.0 Management and Responsibilities V1M2 Sec. 4 8.2.4; 8.2.5
4.1 Overview V1M2 Secs. 4.1.1,
4.1.3; 4.1.5
4.1.1; 4.1.3;
4.1.5; 4.2.6
5.1; 5.2;
5.5; 5.6 ;
6.2.1; 6.2.4
4.2 Roles and Responsibilities V1M2 Secs. 4.1.4;
4.1.5; 4.1.6; 4.2.1;
4.2.6; 5.2.4
4.1.3; 4.1.5;
4.1.6; 4.2.1;
4.2.6; 5.2.4
4.1.1 to 4.1.3;
4.1.5; 5.5;
5.6; 6.2.1;
6.2.4; 6.2.6
8.2.2;
4.3 Business Continuity and Contingency
Plan (Prev. Deputies)
V1M2 Secs. 4.1.5;
4.1.7.2; 4.2.7
4.1.5; 4.2.7
5.0 PERSONNEL V1M2 Secs. 5.2;
5.2.1
5.2.1 6.1; 6.2.3
5.1 Overview V1M2 Secs. 5.2.2;
5.2.3; 5.2.5
5.2.2; 5.2.3;
5.2.5
6.2.2
5.2 Education and Experience Requirements
for Technical Staff
V1M2 Secs. 5.2.1;
5.2.3; 5.2.4
5.2.1; 5.2.3;
5.2.4
6.2.2 to 6.2.4
5.3 Training V1M2 Sec. 5.2.5 5.2.5 4.2.1; 6.2.2;
6.2.4; 6.2.5
5.4 Data Integrity and Ethics Training
Program
V1M2 Sec. 4.2.8.1;
5.2.7
4.1.1
6.0 ACCOMMODATIONS AND
ENVIRONMENTAL CONDITIONS
V1M2 Sec. 5.3 6.1; 6.3.1
6.1 Overview V1M2 Secs. 5.3.1;
5.3.3; 5.3.4; 5.3.5
5.3.1; 5.3.3;
5.3.4; 5.3.5
6.3.1
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Sec.
No. Title
2009 and 2016
TNI Standard
Reference
ISO/IEC
17025:2005(E)
Reference
ISO/IEC
17025:2017(E)
Reference
6.2 Environment V1M2 Secs. 5.3.1;
5.3.2; 5.3.3; 5.3.4;
5.3.5
5.3.1; 5.3.2;
5.3.3; 5.3.4;
5.3.5
6.3.1 to 6.3.5
6.3 Work Area V1M2 Secs. 5.3.3;
5.3.4; 5.3.5
5.3.3; 5.3.4;
5.3.5
6.3.1
6.4 Responding to Emergencies
6.5 Building Security V1M2 Sec. 5.3.4 5.3.4 6.3.4
7.0 QUALITY SYSTEM 6.1; 8.2.4
7.1 Quality Policy V1M2 Secs. 4.1.5;
4.2.2; 4.2.3; 4.2.8.3
4.1.5; 4.2.2;
4.2.3
8.2.3; 8.6.1
7.2 Ethics and Data Integrity
V1M2 Secs. 4.1.5;
4.16; 4.2.2; 4.2.8.1;
5.2.7
4.1.5; 4.2.2 4.1.1 to 4.1.3;
4.2.1; 6.2.1;
8.2.2; 8.2.3
7.3 Quality System Documentation V1M2 Secs. 4.1.5;
4.2.2; 4.2.5
4.2.2; 4.2.5 8.2.4
7.4 QA/QC Objectives for the Measurement
of Data
V1M2 Sec. 4.2.2 4.1.5; 4.2.2 6.2.4
7.5 Criteria for Quality Indicators
7.6 Statistical Quality Control
7.7 Quality System Metrics
8.0 Document Control V1M2 Secs. 4.2.7;
4.3.1; 4.3.2.2 ;
4.3.3.3; 4.3.3.4
4.2.7; 4.3.1;
4.3.2.2; 4.3.3.3;
4.3.3.4
8.2.4; 8.3.1
8.1 Overview 8.2.5; 8.3.1;
8.3.2
8.2 Document Approval and Issue V1M2 Secs. 4.3.2;
4.3.2.1-4.3.2.3;
4.3.3.1
4.3.2.1; 4.3.2.2;
4.3.2.3; 4.3.3.1
8.2.5; 8.3.2
8.3 Procedures for Document Control Policy V1M2 Secs. 4.3.2.1–
4.3.2.2; 4.3.3.1
4.3.2.1; 4.3.2.2;
4.3.3.1
8.2.5; 8.3.2
8.4 Obsolete Documents V1M2 Secs. 4.3.2.1–
4.3.2.2
4.3.2.1; 4.3.2.2 8.2.5; 8.3.2
9.0 SERVICE TO THE CLIENT V1M2 Secs. 4.4.1 -
4.4.4
4.4.1; 4.4.2;
4.4.3; 4.4.4
7.1.1; 7.1.1.4;
7.1.1.5; 7.1.1.8;
7.1.2.1
9.1 Overview V1M2 Secs. 4.4.5;
4.5.5; 5.7.1
4.4.5; 5.7.1
9.2 Review Sequence and Key Personnel V1M2 Sec. 4.4.5 4.4.5 7.1.1.6
9.3 Balancing Laboratory Work Load and
Capacity

9.4 Documentation V1M2 Sec. 5.7.1 5.7.1
9.5 Special Services V1M2 Secs. 4.7.1-
4.7.2
4.7.1; 4.7.2 7.1.1.3; 7.1.1.7
9.6 Client Communication V1M2 Secs. 4.7.1-
4.7.2
4.7.1; 4.7.2 7.1.1.7
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Sec.
No. Title
2009 and 2016
TNI Standard
Reference
ISO/IEC
17025:2005(E)
Reference
ISO/IEC
17025:2017(E)
Reference
9.7 Reporting V1M2 Secs. 4.7.1-
4.7.2
4.7.1; 4.7.2 7.1.1.7
9.8 Client Feedback and Surveys V1M2 Secs. 4.7.1-
4.7.2
4.7.1; 4.7.2 7.1.1.7; 8.6.2
10.0 SUBCONTRACTING OF TESTS V1M2 Secs. 4.4.3;
4.5.4
4.4.3; 4.5.4
10.1 Overview V1M2 Secs. 4.5.1 -
4.5.3; 4.5.5; 5.3.1
4.5.1; 4.5.2;
4.5.3; 5.3.1
6.6.1; 7.1.2.1;
7.1.2.2
10.2 Qualifying and Monitoring Subcontractors V1M2 Secs. 4.5.1;
4.5.2; 4.5.3; 4.5.5
4.5.1; 4.5.2;
4.5.3
6.6.1; 7.1.2.1;
7.1.2.2
10.3 Oversight and Reporting V1M2 Sec. 4.5.5
10.4 Contingency Planning
10.5 Use of NELAP and A2LA Logo
11.0 PURCHASING SERVICES AND
SUPPLIES
V1M2 Sec. 4.6.1 4.6.1
11.1 Overview V1M2 Secs. 4.6.2;
4.6.3; 4.6.4
4.6.2; 4.6.3;
4.6.4
6.6.1; 6.6.2
11.2 Glassware V1M2 Sec. 5.5.13.1
11.3 Reagents, Standards & Supplies V1M2 Secs. 4.6.2;
4.6.3; 4.6.4
2016 V1M4 1.7.2.5
4.6.2; 4.6.3;
4.6.4
6.6.1 to 6.6.3
11.4 Purchase of Equipment / Instruments /
Software

11.5 Services
11.6 Suppliers
12.0 COMPLAINTS V1M2 Sec. 4.8 4.8 8.6.1; 8.6.2
12.1 Overview 7.9.1 to 7.9.3
8.6.1; 8.6.2;
12.2 External Complaints 7.9.2 to 7.9.7
8.6.1; 8.6.2;
12.3 Internal Complaints 8.6.1; 8.6.2
12.4 Management Review 8.6.1; 8.6.2
13.0 CONTROL OF NON-CONFORMING
WORK
V1M2 Secs. 4.9.1;
5.10.5
4.9.1; 5.10.5 7.10.1
13.1 Overview V1M2 Secs. 4.9.1;
4.11.3; 4.11.5
4.9.1; 4.11.3;
4.11.5
7.10.1
13.2 Responsibilities and Authorities V1M2 Secs. 4.9.1;
4.11.3; 4.11.5; 5.2.7
4.9.1; 4.11.3;
4.11.5
7.10.1
13.3 Evaluation of Significance and Action
Taken
V1M2 Secs. 4.9.1;
4.11.3; 4.11.5
4.9.1; 4.11.3;
4.11.5
4.1.5;
7.10.1; 7.10.2;
8.5.3
13.4 Prevention of Non-Conforming Work V1M2 Secs. 4.9.4;
4.11.2
4.9.2; 4.11.2 7.10.2; 7.10.3;
8.5.3
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Sec.
No. Title
2009 and 2016
TNI Standard
Reference
ISO/IEC
17025:2005(E)
Reference
ISO/IEC
17025:2017(E)
Reference
13.5 Method Suspension / Restriction (Stop
Work Procedures)
V1M2 Secs. 4.9.1;
4.9.2; 4.11.5
4.9.1; 4.9.2;
4.11.5
7.10.1; 7.10.2
14.0 CORRECTIVE ACTION V1M2 Sec. 4.11 4.1.4; 4.1.5
14.1 Overview V1M2 Secs. 4.9.2;
4.11.1; 4.11.2
4.9.2; 4.11.1;
4.11.2; 8.7.1;
8.7.3
7.10.2 8.7.1;
8.7.3;
14.2 General V1M2 Sec. 4.11.2;
4.11.3
4.11.2; 4.11.3 7.7.2; 8.5.3;
8.7.1;
14.3 Closed Loop Correction Action Process V1M2 Sec. 4.11.2;
4.11.3; 4.11.4;
4.11.6; 4.11.7;
4.12.2
4.11.2; 4.11.3;
4.11.4; 4.12.2
8.5.3; 8.6.1;
8.7.2
14.4 Technical Corrective Actions V1M2 Sec. 4.11.6 8.7.1
14.5 Basic Corrections V1M2 Secs. 4.11.1;
4.13.2.3
4.11.1; 4.13.2.3 7.5.2; 8.7.1
15.0 PREVENTIVE ACTION /
IMPROVEMENT
V1M2 Secs. 4.10;
4.12.1; 4.12.2
4.10; 4.12.1;
4.12.2
4.1.4
15.1 Overview V1M2 Secs. 4.15.1;
4.15.2
4.15.1; 4.15.2 8.6.2
15.2 Management of Change
16.0 CONTROL OF RECORDS V1M2 Secs. 4.2.7;
4.13.1.1; 4.13.3
4.2.7; 4.13.1.1 8.4.2
16.1 Overview V1M2 Secs.
4.13.1.1 - 4.13.1.4;
4.13.2.1-4.13.2.3;
4.13.3
4.13.1.1 -
4.13.1.4;
4.13.2.1-
4.13.2.3
8.4.1; 8.4.2

16.2 Programs with Longer Retention
Requirements

16.3 Technical and Analytical Records V1M2 Sec. 4.13.2.2
- 4.13.2.3
4.13.2.2;
4.13.2.3
7.5.1; 8.4.2
16.4 Laboratory Support Activities 7.5.2; 8.4.2
16.5 Administrative Records 8.4.2
16.6 Records Management, Storage and
Disposal
V1M2 Sec. 4.13.3 4.2.1; 8.4.2
17.0 AUDITS
17.1 Internal Audits V1M2 Sec. 4.2.8.1;
4.14; 4.14.1; 4.14.2 ;
4.14.3; 4.14.5; 5.9.1;
5.9.2
4.14.1; 4.14.2;
4.14.3; 5.9.1;
5.9.2
8.6.1; 8.8.1;
8.8.2
17.2 External Audits V1M2 Secs.4.14.2;
4.14.3
4.14.2; 4.14.3;
4.14.4
4.2.1; 8.6.1
17.3 Audit Findings V1M2 Secs. 4.14.2;
4.14.3; 4.14.5
8.6.1
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Sec.
No. Title
2009 and 2016
TNI Standard
Reference
ISO/IEC
17025:2005(E)
Reference
ISO/IEC
17025:2017(E)
Reference
18.0 MANAGEMENT REVIEWS V1M2 Sec. 4.1.6;
4.15; 4.15.1; 4.15.2
4.1.6; 4.15.1;
4.15.2
4.1.4; 8.5.1;
8.6.1; 8.9.1;
8.9.2
18.1 Quality Assurance Report 8.5.1
18.2 Annual Management Review V1M2 Sec. 4.2.2;
4.15.3
4.2.2 4.1.1, 4.1.4;
4.2.1; 7.1.1.3;
8.2.2;
8.5.1 to 8.5.3;
8.6.1; 8.9.3
18.3 Potential Integrity Related Managerial
Reviews
4.1.5; 8.5.1;
8.6.1
19.0 TEST METHODS AND METHOD
VALIDATION
V1M2 Sec. 5.4.1 5.4.1 7.2.1.1; 8.2.5
19.1 Overview V1M2 Sec. 5.4.1 5.4.1; 5.4.5.1 6.2.3;
7.2.1.1 to
7.2.1.3
19.2 Standard Operating Procedures (SOPs) V1M2 Secs. 4.2.8.5;
4.3.3.1; 5.4.2
4.3.3.1; 5.4.2 7.2.1.4
19.3 Laboratory Methods Manual V1M2 Sec. 4.2.8.5
(2019 5.4.4.2)
6.2.3
19.4 Selection of Methods V1M2 Secs. 4.13.3;
5.4.1; 5.4.2; 5.4.3.
(2019 5.4.4)
V1M4 Secs. 1.4;
1.5.1; 1.6.1; 1.6.2;
1.6.2.1; 1.6.2.2
5.4.1; 5.4.2;
5.4.3; 5.4.4;
5.4.5.1; 5.4.5.2;
5.4.5.3
7.1.1.2; 7.2;
7.2.1.2;
7.2.1.3;
7.1.2.4 to
7.2.1.7;
7.2.2.1 to
7.2.1.7;
7.2.2.1
19.5 Laboratory Developed Methods and Non-
Standard Methods
V1M2 Sec. 5.4.2.
(2019 5.4.4.1,
5.4.4.2)
V1M4 Sec. 1.5.1
5.4.2; 5.4.4;
5.4.5.2; 5.4.5.3
7.1.1.2;
7.2.1.4 to
7.2.1.7
7.2.2.1; 7.2.2.3;
8.2.5
19.6 Validation of Methods V1M2 Sec. 5.4.2.
(2019 5.4.5.4) V1M4
Secs. 1.5.1; 1.5.2;
1.5.2.1; 1.5.2.2;
1.5.3
5.4.2; 5.4.4;
5.4.5.2; 5.4.5.3
7.1.1.2; 7.1.2.4;
7.2.1.6;
7.2.2.1 to
7.2.2.4
19.7 Method Detection Limits (MDLs) / Limit of
Detection (LOD)
V1M2 Sec. 5.9.3.
V1M4 Secs. 1.5.2;
1.5.2.1; 1.5.2.2
5.4.5.3 7.2.2.3
19.8 Verification of Detection Limits V1M2 Sec. 5.9.3
19.9 Instrument Detection Limits (IDLs) V1M2 Sec. 5.9.3.
V1M4 Sec. 1.5.2.1

19.10 Limit of Quantitation V1M2 Sec. 5.9.3
19.11 Retention Windows V1M2 Sec. 5.9.3.
V1M4 Sec. 1.5.4;
(2009 1.7.3.6) (2016
1.7.2.6)

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Sec.
No. Title
2009 and 2016
TNI Standard
Reference
ISO/IEC
17025:2005(E)
Reference
ISO/IEC
17025:2017(E)
Reference
19.12 Evaluation of Selectivity V1M2 Sec. 5.9.3.
V1M4 Sec. 1.5.4;
(2009 1.7.3.6)
(2016 1.7.2.6)

19.13 Estimation of Uncertainty of
Measurement
V1M2 Sec. 5.1.1;
5.1.2; 5.4.6
5.1.1; 5.1.2;
5.4.6.1; 5.4.6.2;
5.4.6.3
7.6.1; 7.6.2;
7.6.3
19.14 Sample Reanalysis Guidelines V1M2 Sec 5.9.1 5.9.1
19.15 Control of Data V1M2 Secs. 5.4.7.1;
5.4.7.2; 5.9.1
5.4.7.1; 5.4.7.2;
5.9.1
7.11.1 to 7.11.6
20.0 EQUIPMENT AND CALIBRATIONS V1M2 Secs. 5.5.4;
5.5.5; 5.5.6
5.5.4; 5.5.5;
5.5.6; 5.6.1
6.1; 6.4.3;
6.4.6; 6.4.9
20.1 Overview V1M2 Secs. 5.5.1;
5.5.2; 5.5.3; 5.5.5;
5.5.10
5.5.1; 5.5.2;
5.5.3; 5.5.5;
5.5.10; 5.6.1
6.4.1;
6.4.4 to 6.4.6;
6.4.9; 6.4.11
20.2 Preventive Maintenance V1M2 Secs. 5.5.1;
5.5.3; 5.5.7; 5.5.9
5.5.1; 5.5.3;
5.5.7; 5.5.9;
5.6.1
6.4.1 to 6.4.3;
6.4.6; 6.4.10
20.3 Support Equipment V1M2 Secs. 5.5.10;
5.5.11; 5.5.13.1
5.5.10; 5.5.11;
5.6.2.1.2;
5.6.2.2.1;
5.6.2.2.2
6.4.11; 6.4.12;
6.5.1; 6.5.2;
6.5.3
20.4 Instrument Calibrations V1M2 Secs. 5.5.8;
5.5.10; 5.6.3.1.
V1M4 Sec. 1.7.1.1;
(2009 1.7.2)
(2016 1.7.1.2)
5.5.8; 5.5.9;
5.5.10; 5.6.1;
5.6.2; 5.6.3.1
6.4.2; 6.4.3;
6.4.6 to 6.4.8;
6.4.11; 6.4.13;
6.4.14; 6.5.1;
6.5.2
20.5 Tentatively Identified Compounds (TICs)
– GC/MS Analysis

20.6 GC/MS Tuning
21.0 MEASUREMENT OF TRACEABILITY
21.1 Overview V1M2 Sec. 5.6.3.1 5.6.2.1.2;
5.6.2.2.2; 5.6.3.1
6.4.14; 6.5.1;
6.5.2; 6.5.3
21.2 NIST-Traceable Weights and
Thermometers
V1M2 Secs.
5.5.13.1; 5.6.3.1;
5.6.3.2
5.6.3.1;
5.6.3.2
6.4.14
21.3 Reference Standards / Materials V1M2 Secs. 5.6.3.1;
5.6.3.2; 5.6.3.3;
5.6.3.4; 5.6.4.1;
5.6.4.2; 5.9.1; 5.9.3
5.6.3.1; 5.6.3.2;
5.6.3.3; 5.6.3.4;
5.9.1
6.4.14
21.4 Documentation and Labeling of
Standards, Reagents, and Reference
Materials
V1M2 Secs. 5.6.4.2;
5.9.3

22.0 SAMPLING
22.1 Overview V1M2 Secs. 5.7.1;
5.7.3
5.7.1;
5.7.3
7.3.1; 7.3.2;
7.3.3
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Sec.
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2009 and 2016
TNI Standard
Reference
ISO/IEC
17025:2005(E)
Reference
ISO/IEC
17025:2017(E)
Reference
22.2 Sampling Containers
22.3 Definition of Holding Time
22.4 Sampling Containers, Preservation
Requirements, Holding Times

22.5 Sample Aliquots / Subsampling V1M2 Sec. 5.7.1 5.7.1 7.3.1; 7.3.2
23.0 HANDLING OF SAMPLES V1M2 Sec. 5.8.1 5.8.1 7.4.1
23.1 Chain of Custody (CoC) V1M2 Secs. 5.7.2;
5.7.4; 5.8.4; 5.8.7.5;
5.8.8; 5.9.1
5.7.2; 5.8.4;
5.9.1
7.1.1.6; 7.4.1
23.2 Sample Receipt V1M2 Secs. 5.8.1;
5.8.2; 5.8.3; 5.8.5;
5.8.7.3; 5.8.7.4;
5.8.7.5
5.8.2; 5.8.3 7.4.3
23.3 Sample Acceptance Policy V1M2 Secs. 5.8.6;
5.8.7.2

23.4 Sample Storage V1M2 Secs. 5.7.4;
5.8.4
5.8.4 7.4.1; 7.4.4
23.5 Hazardous Samples and Foreign Solids
23.6 Sample Shipping V1M2 Sec. 5.8.2 5.8.2 7.4.2
23.7 Sample Disposal
24.0 ASSURING THE QUALITY OF TEST
RESULTS

24.1 Overview V1M2 Secs. 5.9.2;
5.9.3
5.9.2 7.7.2 to 7.7.3
24.2 Controls V1M2 Secs. 5.9.2;
5.9.3
5.9.2 7.7.1; 7.7.3
24.3 Negative Controls V1M2 Secs. 5.9.2;
5.9.3
V1M4 Secs.
(2019 1.7.3; 1.7.3.1;
1.7.4.1)
(2016 1.7.2, 1.7.2.1,
1.7.3.1)
5.9.2 7.7.1; 7.7.3
24.4 Positive Controls V1M2 Secs 5.9.2;
5.9.3.
V1M4 Secs.(2009
1.7.3; 1.7.3.2;
1.7.3.2.1; 1.7.3.2.2;
1.7.3.2.3)
(2016 1.7.2, 1.7.2.2,
1.7.3.2)
5.9.2 7.7.1; 7.7.3
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Company Confidential & Proprietary
Sec.
No. Title
2009 and 2016
TNI Standard
Reference
ISO/IEC
17025:2005(E)
Reference
ISO/IEC
17025:2017(E)
Reference
24.5 Sample Matrix Controls V1M2 Secs. 5.9.2;
5.9.3.
V1M4 Secs. (2009
1.7.3 ; 1.7.3.3;
1.7.3.3.1; 1.7.3.3.2;
1.7.3.3.3)
(2016 1.7.2, 1.7.2.3,
1.7.3.3)
5.9.2 7.7.1; 7.7.3
24.6 Acceptance Criteria (Control Limits) V1M2 Sec. 5.9.3.
V1M4 Secs. 1.7.4.2;
1.7.4.3
7.7.1; 7.7.3
24.7 Additional Procedures to Assure Quality
Control
V1M2 Sec. 5.9.3.
V1M4 Sec. (2009
1.7.3.4), (2016
1.7.2.4)
7.7.1; 7.7.3
25.0 REPORTING RESULTS
25.1 Overview V1M2 Secs. 5.10.1;
5.10.2; 5.10.8
5.10.1; 5.10.2;
5.10.8
7.8.1 to 7.8.2
25.2 Test Reports V1M2 Secs. 5.10.1;
5.10.2; 5.10.3.1;
5.10.3.2; 5.10.5;
5.10.6; 5.10.7;
5.10.8; 5.10.10;
5.10.11
5.10.1; 5.10.2;
5.10.3.1;
5.10.3.2; 5.10.5;
5.10.6; 5.10.7;
5.10.8
7.8.2.1;
7.8.2.2; 7.8.3;
7.8.5
25.3 Reporting Level or Report Type V1M2 Secs. 5.10.1;
5.10.7; 5.10.8
5.10.1; 5.10.7;
5.10.8

25.4 Electronic Data Deliverables (EDDs)
25.5 Supplemental Information for Test V1M2 Secs. 5.10.1;
5.10.3.1; 5.10.5
5.10.1; 5.10.3.1;
5.10.5
7.1.1.3; 7.8.6.1;
7.8.6.2;
7.8.7.1 to
7.8.7.3
25.6 Environmental Testing Obtained from
Subcontractors
V1M2 Secs. 4.5.5;
5.10.1; 5.10.6
5.10.1; 5.10.6
25.7 Client Confidentiality V1M2 Secs. 4.1.5;
5.10.7
4.1.5; 5.10.7 4.2.1 to 4.2.4
25.8 Format of Reports V1M2 Sec. 5.10.8 5.10.8
25.9 Amendments to Reports V1M2 Sec. 5.10.9 5.10.1; 5.10.9 7.8.8.1 to
7.8.8.3
25.10 Policies on Client Requests for
Amendments
V1M2 Secs. 5.9.1;
5.10.9
5.9.1; 5.10.1;
5.10.5; 5.10.9

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LIST OF TABLES

Table
No.

Title
2009 and 2016 TNI
Standard
Reference
ISO/IEC
17025:2005 (E)
Reference
ISO/IEC
17025:2017(E)
Reference
14-1 Example – General Corrective Action
Procedures
V1M2 Sec. 4.11.6.
V1M4 Sec. (2009
1.7.4.1) (2016
1.7.1.2, 1.7.2.1,
1.7.2.3, 1.7.3.1 )
4.11.2
16-1 Record Index 4.13.1.1
16-2 Example – Special Record Retention
Requirements

17-1 Type of Internal Audits and Frequency 4.14.1
20-1 Example – Instrumentation List 5.5.4; 5.5.5
24-1 Example – Negative Controls
24-2 Negative Controls for Microbiology
24-3 Sample Matrix Controls

LIST OF FIGURES
Figure
No. Title
2009 and 2016 TNI
Standard
Reference
ISO/IEC
17025:2005(E)
Reference
ISO/IEC
17025:2017(E)
Reference
4-1 Laboratory Organization Charts
V1M2 Sec. 4.1.5 4.1.3;
4.1.5; 4.2.6

19-1 Example – Work Flow
23-2 Example – Sample Acceptance Policy
V1M2 Sec. 5.8.6;
5.8.7.1
V1M4 Sec.
(2009 1.7.5)
(2016 1.7.4)

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Appendix 5. Terms/Glossary and Acronyms (EL-V1M2 Sec. 3.1)

Terms/Glossary:
Acceptance Criteria: Specified limits placed on characteristics of an item, process, or service defined in
requirement documents. (ASQC)
Accreditation: The process by which an agency or organization evaluates and recognizes a laboratory as
meeting certain predetermined qualifications or standards, thereby accrediting the laboratory.
Accuracy: The degree of agreement between an observed value and an accepted reference value.
Accuracy includes a combination of random error (precision) and systematic error (bias) components which
are due to sampling and analytical operations; a data quality indicator. (QAMS)
Analyst: The designated individual who performs the “hands-on” analytical methods and associated
techniques and who is the one responsible for applying required laboratory practices and other pertinent
quality controls to meet the required level of quality.
Analytical Uncertainty: A subset of Measurement Uncertainty that includes all laboratory activities
performed as part of the analysis. (TNI)
Anomaly: A condition or event, other than a deficiency, that may affect the quality of the data, whether in
the laboratory’s control or not.
Assessment: The evaluation process used to measure or establish the performance, effectiveness, and
conformance of an organization and/or its systems to defined criteria (to the standards and requirements
of laboratory accreditation). (TNI)
Audit: A systematic and independent examination of facilities, equipment, personnel, training, procedures,
record-keeping, data validation, data management, and reporting aspects of a system to determine whether
QA/QC and technical activities are being conducted as planned and whether these activities will effectively
achieve quality objectives. (TNI)
Batch: Environmental samples that are prepared and/or analyzed together with the same process and
personnel, using the same lot(s) of reagents. A preparation batch is composed of one (1) to twenty (20)
environmental samples of the same quality systems matrix, meeting the above mentioned criteria and with
a maximum time between the start of processing of the first and last sample in the batch to be twenty-four
(24) hours. An analytical batch is composed of prepared environmental samples (extracts, digestates or
concentrates) which are analyzed together as a group. An analytical batch can include prepared samples
originating from various quality system matrices and can exceed twenty (20) samples. (TNI)
Bias: The systematic or persistent distortion of a measurement process, which causes errors in one
direction (i.e., the expected sample measurement is different from the sample’s true value). (TNI)
Blank: A sample that has not been exposed to the analyzed sample stream in order to monitor
contamination during sampling, transport, storage or analysis. The bla nk is subjected to the usual analytical
and measurement process to establish a zero baseline or background value and is sometimes used to
adjust or correct routine analytical results. (ASQC)
Calibration: A set of operations that establish, under specified conditions, the relationship between values
of quantities indicated by a measuring instrument or measuring system, or values represented by a material
measure or a reference material, and the corresponding values realized by standards. (TNI)

1) In calibration of support equipment the values realized by standards are established through the use
of reference standards that are traceable to the International System of Units (SI).
2) In calibration according to methods, the values realized by standards are typically established
through the use of Reference Materials that are either purchased by the laboratory with a certif icate of
analysis or purity, or prepared by the laboratory using support equipment that has been calibrated or
verified to meet specifications.
Calibration Curve: The mathematical relationship between the known values, such as concentrations, of
a series of calibration standards and their instrument response. (TNI)
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Calibration Standard: A substance or reference material used to calibrate an instrument (QAMS)
Certified Reference Material (CRM): A reference material accompanied by a certif icate, having a value,
measurement uncertainty, and stated metrological traceability chain to a national metrology institute. (TNI)
Chain of Custody (COC) Form: Record that documents the possession of the samples from the time of
collection to receipt in the laboratory. This record generally includes: the number and types of containers;
the mode of collection; the collector; time of collection; preservation; and requested analyses. (TNI)
Compromised Samples: Those samples which are improperly sampled, insufficiently documented (chain
of custody and other sample records and/or labels), improperly preserved, collected in improper containers,
or exceeding holding times when delivered to a laboratory. Under normal conditions, compromised
samples are not analyzed. If emergency situation require analysis, the results must be appropriately
qualified.
Confidential Business Information (CBI): Information that an organization designates as having the
potential of providing a competitor with inappropriate insight into its management, operation or products.
TNI and its representatives agree to safeguard identified CBI and to maintain all information identified as
such in full confidentiality.
Confirmation: Verification of the identity of a component through the use of an approach with a different
scientific principle from the original method. These may include, but are not limited to Second Column
Confirmation; Alternate wavelength; Derivatization; Mass spectral interpretation; Alternative detectors or
Additional Cleanup procedures. (TNI)
Conformance: An affirmative indication or judgment that a product or service has met the requirements
of the relevant specifications, contract, or regulation; also the state of meeting the requirements.
(ANSI/ASQC E4-1994)
Correction: Actions necessary to correct or repair analysis specific non-conformances. The acceptance
criteria for method specific QC and protocols as well as the associated corrective actions. The analyst will
most frequently be the one to identify the need for this action as a result of calibration checks and QC
sample analysis. No significant action is taken to change behavior, process or procedure.
Corrective Action: The action taken to eliminate the causes of an existing nonconformity, defect or other
undesirable situation in order to prevent recurrence. (ISO 8402)
Data Integrity: The condition that exists when data are sound, correct, and complete, and accurately
reflect activities and requirements. (TNI)
Data Audit: A qualitative and quantitative evaluation of the documentation and procedures associated with
environmental measurements to verify that the resulting data re of acceptable quality (i.e., that they meet
specified acceptance criteria).
Data Reduction: The process of transforming the number of data items by arithmetic or statistical
calculations, standard curves, and concentration factors, and collation into a more useable form. (TNI)
Deficiency: An unauthorized deviation from acceptable procedures or practices, or a defect in an item
(ASQC), whether in the laboratory’s control or not.
Demonstration of Capability: A procedure to establish the ability of the analyst to generate analytical
results of acceptable accuracy and precision. (TNI)
Document Control: The act of ensuring that documents (and revisions thereto) are proposed, reviewed
for accuracy, approved for release by authorized personnel, distributed properly, and controlled to ensure
use of the correct version at the location where the prescribed activity if performed. (ASQC)
Duplicate Analyses: The analyses or measurements of the variable of interest performed identically on
two subsamples of the same sample. The results from dupl icate analyses are used to evaluate analytical
or measurement precision but not the precision of sampling, preservation or storage internal to the
laboratory. (EPA-QAD)
Equipment Blank: Sample of analyte-free media which has been used to rinse common sampling
equipment to check effectiveness of decontamination procedures.
External Standard Calibration: Calibrations for methods that do not utilize internal standards to
compensate for changes in instrument conditions.
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Field Blank: Blank prepared in the field by filing a clean container with pure de -ionized water and
appropriate preservative, if any, for the specific sampling activity being undertaken (EPA OSWER)
Field of Ac creditation: Those matrix, technology/method, and analyte combinations for which the
accreditation body offers accreditation.
Holding Times: The maximum time that samples may be held prior to analyses and still be considered
valid or not compromised. (40 CFR Part 136)
Internal Standard: A known amount of standard added to a test portion of a sample as a reference for
evaluating and controlling the precision and bias of the applied analytical test method. (TNI)
Internal Standard Calibration: Calibrations for methods that utilize internal standards to compensate for
changes in instrument conditions.
Instrument Blank: A clean sample (e.g., distilled water) processed through the instrumental steps of the
measurement process; used to determine instrument contamination. (EPA-QAD)
Instrument Detection Limit (IDL): The minimum amount of a substance that can be measured with a
specified degree of confidence that the amount is greater than zero using a specific instrument. The IDL is
associated with the instrumental portion of a specific method only, and sample preparation steps are not
considered in its derivation. The IDL is a statistical estimation at a specified confidence interval of the
concentration at which the relative uncertainty is + 100%. The IDL represents a range where qualitative
detection occurs on a specific instrument. Quantitative results are not produced in this range.
Laboratory Control Sample (however named, such as laboratory fortified blank, spiked blank, or QC
check sample): A sample matrix, free from the analytes of interest, spiked with verified known amounts
of analytes or a material containing known and verified amounts of analytes, taken through all preparation
and analysis steps of the procedure unless otherwise noted in a reference method. It is generally used to
establish intra-laboratory or analyst specific precision and bias or to assess the performance of all or a
portion of the measurement system.
An LCS shall be prepared at a minimum of 1 per batch of 20 or less samples per matrix type per sample
extraction or preparation method except for analytes for which spiking solutions are not available such as
total suspended solids, total dissolved solids, total volatile solids, total solids, pH, color, odor, temper ature,
dissolved oxygen or turbidity. The results of these samples shall be used to determine batch acceptance.
Least Squares Regression (1st Order Curve): The least squares regression is a mathematical calculation
of a straight line over two axes. The y axis represents the instrument response (or Response ratio) of a
standard or sample and the x axis represents the concentration. The regression calculation will generate
a correlation coefficient (r) that is a measure of the "goodness of fit" of the regr ession line to the data. A
value of 1.00 indicates a perfect fit. In order to be used for quantitative purposes, r must be greater than or
equal to 0.99 for organics and 0.995 for inorganics.
Limit(s) of Detection (LOD) [a.k.a., Method Detection Limit (M DL)]: The MDL is the minimum measured
quantity of a substance that can be reported with 99% confidence that the concentration is distinguishable
from method blank results, consistent with 40CFR Part 136 Appendix B, August, 2017.
Limit(s) of Quantitation (LOQ) [a.k.a., Reporting Limit]: The minimum levels, concentrations, or
quantities of a target variable (e.g., target analyte) that can be reported with a specified degree of
confidence.
(QS) Matrix: The component or substrate that contains the analyte of interest. For purposes of batch and
QC requirement determinations, the following matrix distinctions shall be used:
Aqueous: Any aqueous sample excluded from the definition of Drinking Water or Saline/Estuarine.
Includes surface water, groundwater effluents, and TCLP or other extracts.
Drinking Water: Any aqueous sample that has been designated as a potable or potential potable
water source.
Saline/Estuarine: Any aqueous sample from an ocean or estuary, or other salt water source such
as the Great Salt Lake.
Non-Aqueous Liquid: Any organic liquid with <15% settleable solids.
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Biological Tissue: Any sample of a biological origin such as fish tissue, shellfish, or plant material.
Such samples shall be grouped according to origin.
Solids: Includes soils, sediments, sludges, and other matrices with >15% settleable solids.
Chemical Waste: A product or by-product of an industrial process that results in a matrix not
previously defined.
Air & Emissions: W hole gas or vapor samples including those contained in flexible or rigid wall
containers and the extracted concentrated analytes of interest from a gas or vapor that are collected
with a sorbent tube, impinger solution, filter, or other device. (TNI)
Matrix Spike (spiked sample or fortified sample): A sample prepared, taken through all sample
preparation and analytical steps of the procedure unless otherwise noted in a referenced method, by adding
a known amount of target analyte to a specified amount of sample for which an independent test result of
target analyte concentration is available. Matrix spikes are used, for example, to determine the effect of the
matrix on a method's recovery efficiency.
Matrix Spike Duplicate (spiked sample or fortified sample duplicate): A replicate matrix spike prepared
and analyzed to obtain a measure of the precision of the recovery for each analyte.
Method Blank: A sample of a matrix similar to the batch of associated samples (when available) that is
free from the analytes of interest and is processed simultaneousl y with and under the same conditions as
samples through all steps of the analytical procedures, and in which no target analytes or interferences are
present at concentrations that impact the analytical results for sample analyses.
Method Detection Limit: See Limit of Detection (LOD)
Negative Control: Measures taken to ensure that a test, its components, or the environment do not cause
undesired effects, or produce incorrect test results.
Non-conformance: An indication, judgment, or state of not having m et the requirements of the relevant
specifications, contract, or regulation.
Observation: A record of phenomena that (1) may assist in evaluation of the sample data; (2) may be of
importance to the project manager and/or the client, and yet not at the time of the observation have any
known effect on quality.
Performance Audit: The routine comparison of independently obtained qualitative and quantitative
measurement system data with routinely obtained data in order to evaluate the proficiency of an analyst or
laboratory.
Positive Control: Measures taken to ensure that a test and/or its com ponents are working properly and
producing correct or expected results from positive test subjects.
Precision: The degree to which a set of observations or measurements of the same property, obtained
under similar conditions, conform to themselves; a data quality indicator. Precision is usually expressed as
standard deviation, variance or range, in either absolute or relative terms. (TNI)
Preservation: Any conditions under which a sample must be kept in order to maintain chemical and/or
biological integrity prior to analysis. (TNI)
Proficiency Testing: A means of evaluating a laboratory’s performance under controlled conditions
relative to a given set of criteria through analysis of unknown samples provided by an external source. (TNI)
Proficiency Testing Program: The aggregate of providing rigorously controlled and standardized
environmental samples to a laboratory for analysis, reporting of results, statistical evaluation of the results
and the collective demographics and results summary of all participating laboratories. (TNI)
Proficiency Test Sample (PT): A sample, the composition of which is unknown to the laboratory and is
provided to test whether the laboratory can produce analytical results within specified acceptance criteria.
(TNI)
Quality Assurance: An integrated system of management activities involving planning, implementation,
assessment, reporting and quality improvement to ensure that a process, item or service is of the type of
quality needed and expected by the client. (TNI)
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Quality Assurance [Project] Plan (QAPP): A formal document describing the detailed quality control
procedures by which the quality requirements defined for the data and decisions pertaining to a specific
project are to be achieved. (EAP-QAD)
Quality Control: The overall system of technical activities that measures the attributes and performance
of a process, item, or service against defined standards to verify that they meet the stated requirements
established by the customer; operational techniques and activities that are used to fulfill requirements for
quality; also the system of activities and checks used to ensure that measurement systems are maintained
within prescribed limits, providing protection against “out of control” conditions and ensuring that t he results
are of acceptable quality. (TNI)
Quality Control Sample: A sample used to assess the performance of all or a portion of the measurement
system. One of any number of samples, such as Certified Reference Materials, a quality system matrix
fortified by spiking, or actual samples fortified by spiking, intended to demonstrate that a measurement
system or activity is in control. (TNI)
Quality Manual: A document stating the management policies, objectives, principles, organizational
structure and authority, responsibilities, accountability, and implementation of an agency, organization, or
laboratory, to ensure the quality of its product and the utility of its product to its users. (TNI)
Quality System: A structured and documented management system describing the policies, objectives,
principles, organizational authority, responsibilities, accountability, and implementation plan of an
organization for ensuring quality in its work processes, products (items), and services. The quality system
provides the framework for planning, implementing, and assessing work performed by the organization and
for carrying out required QA and QC activities. (TNI)
Raw Data: The documentation generated during sampling and analysis. This documentation includes, but
is not limited to, field notes, electronic data, magnetic tapes, untabulated sample results, QC sample results,
print outs of chromatograms, instrument outputs, and handwritten records. (TNI)
Record Retention: The systematic collection, indexing and storing of documented information under
secure conditions.
Reference Material: Material or substance one or more properties of which are sufficiently homogeneous
and well established to be used for the calibration of an apparatus, the assessment of a measurement
method, or for assigning values to materials. (TNI)
Reference Standard: Standard used for the calibration of working measurement standards in a given
organization or a given location. (TNI)
Sampling: Activity related to obtaining a representative sample of the object of conformity assessment,
according to a procedure.
Second Order Polynomial Curve (Quadratic): The 2nd order curves are a mathematical calculation of a
slightly curved line over two axes. The y axis represents the instrument response (or Response ratio) of a
standard or sample and the x axis represents the concentration. The 2 nd order regression will generate a
coefficient of determination (COD or r2) that is a measure of the "goodness of fit" of the quadratic curvature
the data. A value of 1.00 indicates a perfect fit. In order to be used for quantitative purposes, r2 must be
greater than or equal to 0.99.
Selectivity: The ability to analyze, distinguish, and determine a specific analyte or parameter from another
component that may be a potential interferent or that may behave similarly to the target analyte or parameter
within the measurement system. (TNI)
Sensitivity: The capability of a method or instrument to discriminate between measurement responses
representing different levels (e.g., concentrations) of a variable of interest. (TNI)
Spike: A known mass of target analyte added to a blank, sample or sub-sample; used to determine recovery
efficiency or for other quality control purposes.
Standard: The document describing the elements of laboratory accreditation that has been developed and
established within the consensus principles of standard setting and meets the approval requirements of
standard adoption organizations procedures and policies. (TNI)
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Standard Operating Procedures (SOPs): A written document which details the method for an operation,
analysis, or action, with thoroughly prescribed techniques and steps. SOPs are officially approved as the
methods for performing certain routine or repetitive tasks. (TNI)
Storage Blank: A blank matrix stored with field samples of a similar matrix (volatiles only) that measures
storage contribution to any source of contamination.
Surrogate: A substance with properties that mimic the analyte of interest. It is unlikely to be found in
environment samples and is added to them for quality control purposes.
Surrogate compounds must be added to all samples, standards, and blanks, for all organic chromatography
methods except when the matrix precludes its use or when a surrogate is not available. Poor surrogate
recovery may indicate a problem with sample composition and shall be reported to the client whose sample
produced poor recovery. (QAMS)
Systems Audit (also Technical Systems Audit): A thorough, systematic, qualitative on-site assessment
of the facilities, equipment, personnel, training, procedures, record keeping, data validation, data
management, and reporting aspects of a total measurement system. (EPA-QAD)
Technical Manager: A member of the staff of an environmental laboratory who exercises actual day-to-
day supervision of laboratory operations for the appropriate fields of accreditation and reporting of results
Technology: A specific arrangement of analytical instruments, detection systems, and/or preparation
techniques.
Traceability: The ability to trace the history, application, or location of an entity by means of recorded
identifications. In a calibration sense, traceability relates measuring equipment to national or international
standards, primary standards, basic physical constants or properties, or reference materials. In a data
collection sense, it relates calculations and data generated throughout the project back to the requirements
for the quality of the project. (TNI)
Trip Blank: A blank matrix placed in a sealed container at the laboratory that is shipped, held unopened
in the field, and returned to the laboratory in the shipping container with the field samples.
Uncertainty: A parameter associated with the result of a measurement that characterizes the disper sion
of the value that could reasonably be attributed to the measured value.

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Acronyms:
A2LA – American Association for Laboratory Accreditation
ANSI – American National Standards Institute
ASQ – American Society of Quality
CAR – Corrective Action Report
CCB – Continuing Calibration Blank
CCV – Continuing Calibration Verification
CF – Calibration Factor
CFR – Code of Federal Regulations
COC – Chain of Custody
DOC – Demonstration of Capability
DQO – Data Quality Objectives
DUP - Duplicate
EHS – Environment, Health and Safety
EPA – Environmental Protection Agency
GC - Gas Chromatography
GC/MS - Gas Chromatography/Mass Spectrometry
HPLC - High Performance Liquid Chromatography
ICB – Initial Calibration Blank
ICP - Inductively Coupled Plasma Atomic Emission Spectroscopy
ICP/MS – ICP/Mass Spectrometry
ICV – Initial Calibration Verification
IDL – Instrument Detection Limit
IH – Industrial Hygiene
IS – Internal Standard
LCS – Laboratory Control Sample
LCSD – Laboratory Control Sample Duplicate
LIMS – Laboratory Information Management System
LOD – Limit of Detection
LOQ – Limit of Quantitation
MDL – Method Detection Limit
MDLCK – MDL Check Standard
MDLV – MDL Verification Check Standard
MRL – Method Reporting Limit Check Standard
MS – Matrix Spike
MSD – Matrix Spike Duplicate
NELAP - National Environmental Laboratory Accreditation Program
PT – Performance Testing
TNI – The NELAC Institute
QAM – Quality Assurance Manual
QA/QC – Quality Assurance / Quality Control
QAPP – Quality Assurance Project Plan
RF – Response Factor
RPD – Relative Percent Difference
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RSD – Relative Standard Deviation
SD – Standard Deviation
SDS - Safety Data Sheet
SOP – Standard Operating Procedure
TAT – Turn-Around-Time
VOA – Volatiles
VOC – Volatile Organic Compound

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Appendix 6. Analytical Method References
Reference methods include:
 HASL-300 28th Edition, Environmental Measurements Laboratory (EML), 1997.
 Compendium of Methods for the Determination of Toxic Organic Compounds in Ambient Air , US EPA,
January 1996.
 Guidelines Establishing Test Procedures for the Analysis of Pollutants Under the Clean Water Act;
Analysis and Sampling Procedures; 40CFR Part 136 as amended by Method Update Rule; August 28,
2017.
 Methods for Chemical Analysis of Water and Wastes, EPA 600 (4-79-020), 1983.
 Methods for the Determination of Inorganic Substances in Environmental Samples , EPA-600/R-93/100,
August 1993.
 Methods for the Determination of Metals in Environmental Samples, EPA/600/4-91/010, June 1991.
Supplement I: EPA-600/R-94/111, May 1994.
 Methods for the Determination of Organic Compounds in Drinking Water, EPA-600/4-88-039,
December 1988, Revised, July 1991, Supplement I, EPA-600-4-90-020, July 1990, Supplement II,
EPA-600/R-92-129, August 1992. Supplement III EPA/600/R-95/131 - August 1995 (EPA 500 Series)
(EPA 500 Series methods)
 Technical Notes on Drinking Water Methods, EPA-600/R94-173, October 1994
 Statement of Work for Inorganics & Organics Analysis, SOM and ISM, current versions, USEPA
Contract Laboratory Program Multi-media, Multi-concentration.
 Standard Methods for the Examination of Water and Wastewater, 18th/19th /20th/ on-line edition; Eaton,
A.D. Clesceri, L.S. Greenberg, A.E. Eds; American Water Works Association, Water Pollution Control
Federation, American Public Health Association: Washington, D.C.
 Test Methods for Evaluating Solid Waste Physical/Chemical Methods (SW846), Third Edition,
September 1986, Final Update I, July 1992, Final Update IIA, August 1993, Final Update II, September
1994; Final Update IIB, January 1995; Final Update III, December 1996; Final Update IV, January 2008;
Final Update V, August 2015; Final Update VI, May 2019; Final Update VII, July 2021.
 Annual Book of ASTM Standards, American Society for Testing & Materials (ASTM), Philadelphia, PA.
 National Status and Trends Program, National Oceanographic and Atmospheric Administration,
Volume I-IV, 1985-1994.
 Manual for the Certification of Laboratories Analyzing Drinking Water (EPA 815-R-05-004, January
2005)
 Code of Federal Regulations (CFR) 40, Parts 136, 141, 172, 173, 178, 179 and 261

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Appendix 7. Listing of Methods Performed

Preparation Only Methods
Method Aqueous Solid Waste Biological
Organics
Calif. CAM-WET X X X
EPA 1311 X X X
EPA 1312 (E/W) X X X
EPA 3510C X
EPA 3535 X
EPA 3540B X
EPA 3546 X
EPA 3550B/C X X
EPA 3580A X
EPA 3600C X X X
EPA 3620B X X X
EPA 3630C X X X
EPA 3640A X X X
EPA 5030B/C X X X
EPA 5035, 5035A X X X
Inorganics
Calif. CAM WET X X X
EPA 1311 X X X
EPA 1312 (E/W) X X X
EPA 3005A X
EPA 3010A X
EPA 3050B X X X

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Organics Methods Performed
Parameter Method Aqueous Solid Waste Biological Air
Volatile Organics EPA 8260B/C X X X
Base Neutrals and Acids
(BNAs)
EPA 8270C/D X X X X
Organochlorine Pesticides EPA 8081B X X X X
EPA 1699
PCBs (Aroclors) EPA 8082A X X X X
PCB Congeners EPA 1668A/C X X X X
Petroleum Hydrocarbons EPA 8015C/D
(DRO/ORO)
X X X
EPA 8260B/C (GRO) X X X
Nitrosamines WS-MS-0012 X X
PAHs EPA 8270C/D (SIM) X X X
1,4-Dioxane 8270 C SIM X
Perfluorinated Alkyl
Substances (PFAS),
including PFOA/PFOS
EPA 537 (Modified) X X X X X
EPA 537 (Modified)
in accordance with
QSM 5.4 Table B-15
or higher
X X
X
EPA 1633 X X X
EPA 533 X
EPA 537 X
EPA 537.1 X
Dioxins & Furans EPA 1613B X X X X
EPA 8290/8290A X X X X
EPA 8280A/B X X X X

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Inorganics Methods Performed
Parameter Method Aqueous Solid Waste Biological Air
Alkalinity (Carbonate,
Bicarbonate, Total) SM 2320B X
Bromide, Chloride, and
Fluoride EPA 300.0 X
EPA 9056 / 9056A X X
Chromium, Hexavalent EPA 7196A X
EPA 7199 X
Conductivity EPA 9050A X
EPA 120.1 X
SM 2510 B X
Demand, Chemical Oxygen EPA 410.4 X
SM 5520D X
Moisture ASTM 2216 X
Microplastics CA SWB-MP-1 X
CA SWB-MP-2 X
Nitrate EPA 353.2 X
EPA 300.0 X
EPA 9056 X X
Nitrate-Nitrite EPA 353.2 X
EPA 300.0 X
Nitrite EPA 353.2 X
EPA 300.0 X
EPA 9056 / 9056A X X
Orthophosphate EPA 300.0 X
EPA 9056 / 9056A X
Particulates in Air EPA 5 X
40 CFR Part 50 X
Perchlorate EPA 314.0 X
EPA 331.0 X
EPA 6850 X X
pH SM 4500 H+ B X
EPA 9040A X
EPA 9045C/D X X
Solids, Total SM 2540 B X
Solids, Total Dissolved SM 2540 C X
Solids, Total Suspended SM 2540 D X
Sulfate EPA 300.0 X
EPA 9056 X X
Turbidity EPA 180.1 X

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Metals Methods Performed
Parameter Methods Aqueous Solid Waste Biological Air
Trace Metals EPA 6010B/C/D X X X X
EPA 6020 / 6020A/B X X X X X
EPA 200.8 X
Hardness SM 2340B X
Mercury EPA 7470A X
EPA 7471A/B X X X

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Appendix 8. Listing of Common Data Qualifiers
Data Qualifiers below are examples of the qualifiers available. Qualifiers are defined in each
data package reported, based on the qualifier used and the analysis group for which it is
applied. In specific instances (for instance, programs under the DOD/DOE QSM), the qualifiers
below may not have the same definitions as in the data package used, or different qualifiers
may be used.

Qualifier Qualifier Definition
* LCS or LCSD is outside acceptance limits.
*1 LCS/LCSD RPD exceeds control limits.
*3 ISTD response or retention time outside acceptable limits.
*4 ICPMS relative intensity is outside the method limits.
*5 Isotope dilution analyte is outside acceptance limits.
^ Instrument related QC is outside acceptance limits.
4
MS, MSD: The analyte present in the original sample is greater than 4 times the matrix spike
concentration; therefore, control limits are not applicable.
B Compound was found in the blank and sample.
CI
The peak identified by the data system exhibited chromatographic interference that could not
be resolved. There is reason to suspect there may be a high bias.
cn Refer to Case Narrative for further detail
D
Sample results are obtained from a dilution; the surrogate or matrix spike recoveries reported
are calculated from diluted samples.
E Result exceeded calibration range.
F1 MS and/or MSD recovery exceeds control limits.
F2 MS/MSD RPD exceeds control limits
F3 Duplicate RPD exceeds the control limit
HF
Field parameter with a holding time of 15 minutes. Test performed by laboratory at client's
request.
I Value is EMPC (estimated maximum possible concentration).
J
Result is less than the RL but greater than or equal to the MDL and the concentration is an
approximate value.
ND Compound not detected.
P, p1
The %RPD between the primary and confirmation column/detector is >40%. The lower/higher
value has been reported. (Wording updated based on report context).
Q
The reported result is the estimated maximum possible concentration of this analyte,
quantitated using the theoretical ion ratio. The measured ion ratio does not meet qualitative
identification criteria and indicates a possible interference.
U Indicates the analyte was analyzed for but not detected.
X Surrogate recovery exceeds control limits

Draft
H&P Mobile Geochemistry, Inc.
2470 Impala Drive
Carlsbad, Ca 92010
[phone]
Quality Systems Manual
Revision 21
Revised: July 11, 2022
Effective: July 11, 2022
Approved:
------------------------ ----------------
Lisa Eminhizer Date
Laboratory Director
------------------------ ----------------
Kristin Beckley Date
Quality Assurance Officer
------------------------ ----------------
Dave Balkenbush Date
Field QA/QC Manager
------------------------ ----------------
Eric Corson Date
Field Service Manager
1802203133
07/11/2022
7/11/22
7/19/22
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QSM TABLE OF CONTENTS
SECTION
INTRODUCTION………………………………… ……………………………………….…pg 10
1.0 PURPOSE AND
OBJECTIVES…………………………………………………………………..…..…..pg 10
1.1 Quality Assurance Policy and Objectives
1.1.1 Quality System Review Process
1.2 Standard Operating Procedures (SOPs)
1.2.1 Good Laboratory Practices
1.2.2 Sample Preparation Methods
1.2.3 Sample Analysis Methods
1.2.4 Quality Control Procedures
1.2.5 Acceptance Criteria
1.2.6 Field Sampling Procedures
2.0 ORGANIZATION, MANAGEMENT, PERSONNEL AND TRAINING….…………pg 14
2.1 Company Management
2.2 Company Organization
2.3 Personnel
2.4 Personnel Training
2.4.1 Technical Training
2.4.2 Ethical/Legal Training
2.4.3 Safety Training
2.4.4 Computer Security awareness
2.5 Personnel Records
3.0 FACILITIES, NEW METHODS AND EQUIPMENT PURCHASES………………pg 27
3.1 Laboratory Security
3.1.1 Buildings
3.1.2 Mobile Labs
3.1.3 Strataprobe and Field Vehicles
3.2 Laboratory Management/Field Equipment Management
3.2.1 Mobile Laboratories
3.2.2 Fixed Base Laboratories
3.2.3 Strataprobe and Field Vehicles
3.2.4 Portable Field Instruments, Meters and Detectors
3.2.5 Rental Equipment
3.3 Laboratory Equipment Changes
3.3.1 Market Evaluation
3.3.2 Technical Research
3.3.3 Instrument Set Up
3.3.4 Instrument Operating Conditions
3.3.5 Demonstration of Capability
3.3.6 Method detection Limit and Reporting Limit
3.3.7 Modifications to Standard Methods
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QSM TABLE OF CONTENTS
SECTION
3.3.8 Data Reporting
3.3.9 Software Validation
4.0 SUPPLIES, EQUIPMENT CHECKS AND MAINTENANCE………………..……….pg 35
4.1 Laboratory Supplies
4.1.1 Solvents
4.1.2 Standards
4.1.3 Water
4.1.4 Reagents
4.1.5 VOA Vials
4.1.6 Tedlar Bags
4.1.7 High Pressure & Cryogenic Gases
4.2 Equipment Maintenance and Checks
4.2.1 Gas Chromatographs (GC)
4.2.2 GC/MS
4.2.3 Balance, Toploaders and Weights
4.2.4 Refrigerators
4.2.5 Freezers
4.2.6 Thermometers
4.2.7 Water Dispensers
4.2.8 Vacuum Gauges
4.2.9 Mass Flow Controllers
4.2.10 Summa Canisters
4.2.11 TO-15 Summa Canister Cleaning Systems
4.2.12 LIMS and Server
4.3 Field Sampling Supplies
4.3.1 Soil Vapor Probe Construction Materials
4.3.2 Field Sample Collection Supplies
5.0 GENERAL LABORATORY PROCEDURES…………………………………………….pg 49
5.1 Glassware
5.2 Waste Management/Pollution Prevention
5.2.1 Waste Handling
5.2.2 Waste Removal
6.0 PROJECT MANAGEMENT AND FIELD SAMPLING…………………………………..pg 50
Project management
6.1.1 Site Evaluation
6.1.2 Documentation
6.1.3 Enhanced Quality Assurance
6.2 Sample Containers and Sample Preservation
6.2.1 Volatile organic compounds in gaseous samples
6.2.2 Volatile organic compounds in water
6.2.3 Volatile organic compounds in solid, semi-solid and soil samples
6.2.4 Extractable organic compounds in water
6.2.5 Extractable organic compounds in solid, semi-solid and soil samples
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SECTION
7.0 SAMPLE HANDLING, TRACKING AND SUBCONTRACTING………………...pg 53
7.1 Sample Handling
7.1.1 Sample Control
7.1.1.1 Sample Receipt
7.1.1.2 Sample Acceptance
7.1.1.3 Sample Storage Locations
7.1.1.4 Reviews, Tenders & Contracts
7.1.1.5 Sample Analysis
7.1.1.6 Sample Disposal
7.2 Sample Tracking
7.2.1 Project names and work orders
7.2.2 Filename Assignment
7.3 Subcontracting of Samples Analysis and Field Sampling work
7.3.1 Sample Analysis
7.3.2 Field Sampling
8.0 QUALITY CONTROL, DATA REVIEW, AND PERFORMANCE TESTING …..…pg 60
8.1 Sample Quality Control
8.1.1 Blanks
8.1.1.1 Client Field Blanks
8.1.1.2 H&P Field Blanks
8.1.1.3 Trip Blanks
8.1.1.4 Reagent Blanks
8.1.1.5 Method Blanks
8.1.1.6 Ambient Air Blanks
8.1.2 Instrument Calibration
8.1.2.1 Initial Calibration Curve and Verification
8.1.2.2 Continuing Calibration
8.1.2.3 Quantitation of Samples
8.1.3 Method Checks
8.1.3.1 Laboratory Control Samples (LCS)
8.1.3.2 Matrix Spikes
8.1.3.3 Replicate Analysis
8.1.3.4 Surrogate Analyte Analysis
8.1.3.5 Internal Standards
8.2 Data Review
8.2.1 Data Review Responsibility
8.2.2 Data Review Process
8.2.3 Re-issuance of Reports
8.2.4.1 Data File Security
8.3 Performance Testing
9.0 DATA HANDLING…………………………… …………………………………pg 75
9.1 General Laboratory Data
9.1.1 Standard Prep Log
9.1.2 Refrigerator/Freezer Logs
9.1.3 Instrument Maintenance Logs
9.1.4 Analyst Notebooks for Training
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9.2 Laboratory Sample Data Packages
9.2.1 Tier 1,2 & 3 Review Forms
9.2.2 Sample Extraction/Run Log
9.2.3 Sample Chromatograms
9.2.4 Sampling Log Sheets
9.2.5 Chemist project notes checklist
9.2.6 Sample Chain-of-Custody
9.2.7 Job Confirmation Sheet
9.3 QA/QC Data
9.4 Validation Data
9.5 Data Integrity
9.5.1 Ethics Training
9.5.2 Analyst and Field Technician Decisions
9.5.3 Independent Data Review
9.5.4 Data Review by Management
9.6 Data and Field Sampling Integrity Issues
9.6.1 Initial Evaluation
9.6.2 Corrective Action
9.7 Electronic Transmission of Data
9.8 Data Levels
9.8.1 Data Deliverables Level 3
9.8.2 Data Deliverables Level 4
9.9 Manual Integration of Data
9.9.1 Reasons for Manual Integration
9.9.2 Documentation of Manual Integration
9.9.3 Manual Integration Procedures
10 DOCUMENT CONTROL……………......…………………………………….…………….pg 85
10.8 Project Specific Document Control
10.9 General Laboratory Documents
10.10 Quality Systems Manual (QSM), SOPs and Associated Forms
10.11 Document Records
10.12 Document Security
10.13 Confidential Handling
10.14 Certifications
10.15 Field Sample Collection Records
11.0 CUSTOMER COMPLAINTS, AUDITS, MANAGEMENT REVIEWS, AND NON-
CONFORMANCES …………………………………………………………………pg 88
11.1 Customer Complaints
11.2 Internal Audits
11.2.1 Types of Internal Audits
11.2.2 Internal Audit Responsibility
11.2.3 Internal Audit Process
11.2.4 Preventative/Corrective Actions following Internal Audit
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11.3 Management Reviews
11.3.1 Management Review Responsibility
11.3.2 Management Review Process
11.3.3 Preventative/Corrective Actions following Management Review
11.4 Control of Non-Conformances
11.5 Preventative Action
11.6 Corrective Action
12.0 SAFETY………………………………………………………………………………pg 93
12.1 General Laboratory Safety
12.1.1 Responsibility
12.1.2 Drugs
12.1.3 Compliance
12.1.4 Dress
12.1.5 Safety Glassess
12.1.6 Lab Coats
12.1.7 Respirators
12.1.8 Gloves
12.1.9 Housekeeping
12.1.10 Personal Access to Facilities
12.1.11 Food and Drink in Laboratories
12.1.12 High Pressure Cylinders
12.1.13 Cryogenics
12.2 Equipment Operation
12.2.1 High Voltage Systems
12.2.2 Electrical Systems
12.2.3 Engine Exhaust
12.3 Chemical Handling and Storage
12.3.1 Routine Chemical Handling
12.3.2 Flammable and Potentially Explosive Substances
12.3.3 Hazardous Material Handling
12.4 Job Safety Analysis
13.0 ANALYTICAL TEST METHODS……………………………………………………pg 99
14.0 ANALYTICAL INSTRUMENTATION…………….…….………………..…………pg 100
15.0 ANALYTICAL SOFTWARE…………………………………………………………pg 102
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FIGURES
Section 1.0
None
Section 2.0
Figure 2.1A Sample and Data Flow Chart for In-house samples
Figure 2.1B Sample and Data Flow Chart for Field samples
Figure 2.2 H&P Organization Chart
Section 3.0
None
Section 4.0
None
Section 5.0
None
Section 6.0
None
Section 7.0
None
Section 8.0
None
Section 9.0
Figure 9MA Custom Reports for Internal Standard Summary Sheet Procedure
Figure 9MB Custom Reports for Internal Standard Summary Sheet Procedure
Section 10.0
None
Section 11.0
Figure 11.1 Client Complaint Record
Section 12.0
None
Section 13.0
None
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FIGURES
Section 14.0
None
APPENDICES
Section 1.0
Appendix 1 References and Definitions
Section 2.0
Appendix 2A1 Initial demonstration of capability Chemist (Certificate of Training)
Appendix 2A2 Initial Demonstration of Capability Field Tech (Certificate of Training)
Appendix 2B1 Demonstration of Continuing Proficiency Chemist
Appendix 2B2 Demonstration of Continuing Proficiency Field Tech
Appendix 2C Master Signature List
Section 3.0
Appendix 3A Mobile Lab Inspection Checklist
Appendix 3B1 Mobilization Checklist
Appendix 3B2 Mobile Lab Tool Checklist
Appendix 3C Lab vehicle cleaning checklist
Appendix 3D MDL Summary Sheet
Appendix 3E1 Strataprobe Weekly Inspection Checklist
Appendix 3E2 Support Truck Weekly Inspection Checklist
Appendix 3F Hand Probe Truck Equipment Audit Checklist
Appendix 3G Strataprobe Equipment Audit Checklist
Section 4.0
Appendix 4A Analytical Weight Calibration Form
Appendix 4B Thermometer Calibration Certification
Appendix 4C Glass Syringe Certification
Appendix 4D Minimum performance check and criteria
Appendix 4E Vacuum Gauge Certification
Appendix 4F Digital Thermometer Check
Appendix 4G Water Dispenser Check
Appendix 4H Mass Flow Controller Calibration
Appendix 4I Drilling Equipment and Supply Inventory List
Section 5
None
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APPENDICES
Section 6
Appendix 6A1 & 6A2 Chain-of Custody
Appendix 6B Confirmation Sheet
Section 7.0
Appendix 7A Sample Log In Sheet
Appendix 7B Approved Vendor/Subcontractor List
Appendix 7B2 Approved Vendor List Field Sampling
Section 8.0
Appendix 8A Data Qualifiers Approved for Use
Appendix 8B Tier 1 Report review Checklist
Appendix 8C Tier 2 & 3 Report review Checklist
Section 9.0
Appendix 9A Refrigerator Log Sheets for Bay Refrigerators Parts 1 & 2
Appendix 9B Refrigerator Log Sheets for In-House Refrigerators
Appendix 9C Excursion Log
Appendix 9D Mobile Lab Project Notes Parts 1 & 2
Appendix 9E EPA 8260/H&P 8260SV Analytical Run Log
Appendix 9F EPA TO-15 Analytical Run Log
Appendix 9G TPH DHS-LUFT Analytical Run Log
Appendix 9H Fixed Gases Analytical Run Log
Appendix 9I Helium Analytical Run Log
Appendix 9J – EPA 8021 Analytical Run Log
Appendix 9K – EPA 418.1 Analytical Run Log
Appendix 9L Methane Analytical Run Log
Appendix 9N – H&P TO-14 Analytical Run Log
Appendix 9O Internal Standard Summary Procedure
Appendix 9P Internal Standard Summary Sheet for EPA 8260/H&P 8260SV
Appendix 9Q Internal Standard Summary Sheet for EPA TO-15
Appendix 9R Ethics Policy and Violations
Section 10.0
Appendix 10 Document Distribution List
Appendix 10A Project Report Check out Sheet
Appendix 10B Document Distribution List Field Sampling
Section 11.0
Appendix 11A Customer Service Form
Appendix 11B Internal Audit Analyst Performance Evaluation Form
Appendix 11C Internal Audit TO-15 Analyst Performance Evaluation Form
Appendix 11D - Internal Audit TO-15 Mobile Analyst Performance Evaluation Form
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Appendix 11E Internal Audit Analyst Data Performance Evaluation Form
Appendix 11F Management Review & Action Form
Appendix 11GA Preventative/Corrective Action Form
Appendix 11GB Preventative/Corrective Action Summary
Section 12.0
None
Section 13.0
None
Section 14.0
None
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INTRODUCTION
This Quality Systems Manual (QSM) was established and is implemented by H&P Mobile Geochemistry,
Inc. (H&P) is a California fixed and mobile laboratory specializing in environmental laboratory services
as well as environmental field sampling services. H&P provides analytical testing of soil, water and vapor
media along with sample collection capabilities for these media. H&P's repertoire of environmental
services includes many forms of field sampling techniques, well installation, on-site and off-site analytical
testing of soil, water and/or vapor media for tank removals, ground water monitoring and vapor intrusion
projects.
All reference materials used in the preparation of this document and the Standard Operating Procedures
(SOPs), as well as the definitions of terms used throughout the document are presented in Appendix 1.
1.0 PURPOSE AND OBJECTIVES
This QSM was prepared to comply with the California Environmental Laboratory Accreditation Program
(CA-ELAP) certification as well as other state and national laboratory accreditation programs such as
NELAP, ISO 17025, NEFAB (National Environmental Field Activities Program) and the Department of
Defense (DoD ELAP). The manual applies to our fixed and mobile laboratory services, as well as our
field sampling services that are supported by an administration and QA/QC management at the fixed
facility.
The purpose of this QSM is to:
Define corporate quality assurance (QA) policies and objectives and to state our commitment to
accepted laboratory practices and quality of testing services and to state our commitment to good
FSMO (Field Sampling and Measurement Organization) practices and quality of FSMO services.
To ensure that laboratory and field personnel understand and implement the policies defined in the
QSM.
To provide SOPs for all laboratory procedures, protocols and testing methods.
To provide SOPs for all field sampling procedures, protocols and sampling methods
To meet and/or exceed the requirements of the California ELAP, the Environmental Protection
Agency (EPA), DoD ELAP, NELAP and NEFAP in all analytical testing and/or sampling
services.
1.1 Quality Assurance Policy and Objectives
It is the corporate QA policy to provide the highest quality data, through good laboratory and
FSMO practices, and services to our clients and to continually strive to improve our capabilities
and standards so that we may maintain our position as a leader in the field of soil vapor analysis
and sampling. To accomplish this, the quality assurance (QA) system at H&P is designed to be a
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system of activities that will result in producing legally defensible data that meet customer data
quality requirements in terms of completeness, precision, accuracy, representation, traceability,
documentation and comparability, as well as meet or exceed ELAP, DoD, NELAP, NEFAB and
other accrediting agency requirements. The system is also designed to allow for upgrading of
procedures and methods, for both the laboratory and FSMO practices, when applicable. H&P is
committed to implementation of accepted sampling protocols, laboratory practices and quality of
testing services. H&P personnel will be familiar with the quality practices in this manual and
SOPs and abide by them. All personnel will acknowledge receipt of and adherence to these
policies. This QSM applies to all data produced by all mobile and fixed based laboratories and to
all operations performed by sampling crews operating under the name of H&P.
1.1.1 Quality System Review Process:
It is the responsibility of the President to see that the quality system is reviewed on an
annual basis and that any problems identified are solved through the application of
appropriate corrective actions. The Laboratory Director, the QA Officer, field services
manager operations and the field QA/QC manager will assist in this process. It is the
policy of H&P to review the QSM and all SOPs on a yearly basis.
System/managerial reviews are to involve a review of the QA documentation for
completeness and compliance with Quality Assurance Plan specifications, reviews of
internal audits and performance evaluation samples, external body review, comments by
customers and personnel and all other sources having knowledge of the lab activities. All
laboratory reviews will be conducted by the laboratory director and QA officer and will
cover those activities he/she chooses. All field sampling reviews will be conducted by the
field service manager and field QA/QC manager or the field service manager operations
and field QA/QC manager’s designee. If problems are identified, it is the responsibility of
the President and the Laboratory Director and/or the Field Service manager or field
QA/QC Manager to see that appropriate corrective action is taken.
The results of the review will be documented in memos to applicable employees and
maintained on file by the laboratory director and/or the field operations and QA/QC
manager.
1.2 Standard Operating Procedures (SOPs)
All of H&P’s technical activities are described in this QSM and in SOPs. The QSM and SOP
documents refer to analytical, calibration, computational, quality control, sampling procedures and
operating procedures, as well as laboratory notebook policy and the handling of bench data. The
QSM and SOPs provide a mechanism through which activities will be carried out in a technically
correct, documented and uniform fashion. The QSM may not contain the specific details of how
QA/QC standards are maintained. In these cases, SOPs are provided which will contain all the
details on how an analyst or technician can meet these standards. All SOPs must clarify all
QA/QC criteria so that technical personnel can easily determine when and if their analytical or
sampling system is out-of-control or not in conformance. The SOPs must also provide guidance on
steps to perform to bring the system in control.
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Additions and/or changes to the QSM and SOPs may be recommended by any employee and
presented to the President, Lab Director,QA/QC Officer,Field Service Operations Manager or
Field QA/QC Manager Officer. The recommendation may be verbal or written. Either the
President, Lab Director or Field Operations Services Manager or Field and QA/QC Manager
may decide to take positive action but it is the responsibility of the QA Officer to see that it is
implemented. Implementation consists of having the change/addition written up for review by
technical personnel. If the change/addition can have an impact on data or sampling quality, it
must be tested experimentally to demonstrate that it generates better or equivalent results. The new
procedure is to be validated per H&P’s Method Validation SOP. Once the review is complete the
change/addition is incorporated into the set of SOPs and distributed as described in Section 10 on
Document Control.
1.2.1 Good Laboratory Practices/Field Sampling Practices
Laboratory procedures related to Good Laboratory Practices (GLP) include such things as
the acquisition and use of laboratory supplies and general laboratory equipment. Examples
of such GLP related procedures are the acquisition of solvents and standards, cleaning and
storage of glassware and maintenance of refrigerators, freezers and balances. The content
addressed for these procedures depends heavily on the topic they address.
Field Sampling Practices related to Good Field Sampling Practices (GFSP) include such
things as the acquisition and use of field sampling supplies and general sampling
equipment, the decontamination and storing of supplies and equipment, and the
maintenance of equipment.
1.2.2 Sample Preparation Methods
Sample preparation methods that are not specific to analytical methods are covered in the
QSM. In general, the sample preparation procedures will contain specific information
describing:
Applicable sample matrix or matrices,
Intended application(s),
Initial sample size (including units),
Final sample size (including units),
Summary of the technique,
Specifics related to required steps in the method, and
Specifics related to optional steps in the method.
The extent of detail in these procedures will depend on the extent to which the method is
documented elsewhere. For example, if there is a well-documented EPA sample
preparation method, the procedure needs to contain summary information only but must
reference the EPA method and the EPA method must be on file and readily accessible to
laboratory personnel. If a detailed method does not exist, the procedure must contain
sufficient detail to allow laboratory personnel experienced in the general area of sample
preparation to carry out the procedure.
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1.2.3 Sample Analysis Methods
Analysis methods are to be covered by separate SOPs for each analysis. In general,
analysis method SOPs will contain specific information describing:
The method in summary, including the applicable analytes
Deviations from the EPA method for which H&P is certified for
Instrument and operating conditions
Calibration technique (response factor, regression, etc.)
Initial calibration procedures including the frequency, the number of data points, and
the acceptance criteria
Continuing calibration procedures including the frequency, and the acceptance criteria.
Continuing quality control such as, internal standard responses, and internal standard
retention times, blank requirements
Analyte identification procedure
Calculations
Troubleshooting and Corrective action procedures
Summary of changes to the SOP, following a technical review, will be documented
at the end of the SOP.
The extent of detail in these procedures will depend on the extent to which the method is
documented elsewhere.
1.2.4 Quality Control Procedures
Quality control (QC) procedures are to be covered in each analytical or field sampling SOP
which will contain specific information describing:
Calibration procedures and criteria
Frequency of daily calibration and criteria
Frequency of spiked samples and criteria
Frequency of duplicate or replicate samples and criteria
Frequency of blanks and criteria
The use of surrogates and criteria and
The use of reference materials
Any Decontamination procedures relative to field sampling
The extent of detail in these SOPs will depend on the extent to which QC is documented in
related analysis methods or documented in the field sampling SOPs.
1.2.5 Acceptance Criteria
Acceptance criteria for QC activities may be specified in the method, the SOP for a
method,field sampling activity, or they may be specified by regulation, project, or the
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client. If various standards of Quality Control apply in a given instance, H&P will use the
most stringent requirements that are in effect at the time of analysis.
In general acceptance criteria describe limits for:
Percent difference for daily calibration,
Percent recovery from spiked samples
Percent difference for duplicate or replicate samples
Percent recovery for surrogates
Percent error for reference materials
The extent of detail for the acceptance criteria depends on the requirements and
specifications of the applicable method and its application and/or the end use of the data
generated. The acceptance criteria are to be accompanied with corrective actions where
appropriate.
1.2.6 Field Sampling Procedures
Field sampling procedures are covered by separate SOPs, and/or sampling guides, detailing
each type of field sampling activity. In general, field sampling SOPs will contain specific
information describing:
Collection of soil and groundwater samples
Collection of soil vapor samples into the appropriate sample containers
Proper sampling procedures to fulfill specific regulatory guidelines
Conducting the appropriate leak check procedures
Sample handling
The extent of detail in these procedures will depend on specific sampling guidance to be
followed on a per job basis. The sampling guides act as a more detailed, step-by-step,
instruction guide for specific sampling procedures. Procedures found to be outside of the
standard SOPs and sampling guides are to be accompanied with corrective actions where
appropriate.
2.0 ORGANIZATION, MANAGEMENT, PERSONNEL AND TRAINING
Organization and management of the QA function at H&P involves two independent functions among
five people.
The President is responsible for seeing that appropriate staff, materials and facilities are available such
that customer data quality requirements can be met. This includes review of work plans, work orders,
quotations and contracts for technical feasibility and practical application. The President is further
responsible for seeing that there is a system in place to allow verification of these requirements. The
President is assisted by the Laboratory Director, QA Officer,Field Service Manager,and Field QA/QC
Manager.
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The QA Officer is responsible for seeing that the QA system is being used to generate data will meet
customer requirements. To do this the QA Officer will, 1) review all QAPs and SOPs and 2) provide
training for technical personnel in the QA/QC requirements and procedures for all methods employed.
When review of QA data indicates that corrective action is required, the QA Officer is responsible for
seeing that the correct action is identified and carried out. It is the responsibility of the QA Officer to
maintain SOPs and to see that all technical personnel have access to and have reviewed the most recent
version.
The Laboratory Director is responsible for seeing that the staff, materials and facilities being used to
accomplish a task are capable of carrying out the task in a technically correct fashion. To accomplish this,
the Laboratory Director will, 1) review and authorize all Quality Assurance Plan (QAP) documents and
SOPs, and 2) operate a Data Quality Audit system independent of all technical and laboratory personnel.
It is the responsibility of the Laboratory Director to see that all technical personnel are familiar with and
use the company established SOPs.
The Field Service Manager and Field QA/QC Manager are responsible for seeing that the staff, materials
and facilities being used for all field sampling activities are done so in a technically correct manner. In
order to accomplish this, the Field Service Manager or the Field QA/QC Manager will review and
authorize all field sampling SOPs and sampling guides as well as conduct a field sampling audit system
for all field personnel. It is the responsibility of the Field Service Manager and/or Field QA/QC Manager
to see that all field sampling personnel are familiar with the use of the sampling SOPs and sampling
guides.
H&P’s technical personnel are responsible for carrying out methods as described in the SOPs and
documentation and for fully applying all QA/QC procedures to the work they perform. This includes
completing all documentation in an accurate and timely fashion and taking corrective action when their
QC data indicates this is necessary.
Because technical personnel generate data, the flow of QC data and paperwork is transferred from them to
the QA Officer/ Lab Director.(Figure 2.1A – Sample and Data Flow Chart for In-house received samples)
(Figure 2.1B – Sample and Data Flow Chart for Field received samples).
2.1 Company Management
Company management consists of:
President/Owner: Louise Adams
Financial Officer: Louise Adams
Secretary: Louise Adams
Operations Manager:Suzie Nawikas
Human Resources Manager: Serena Souza (Independent Consultant and Integrity Officer)
Laboratory Director: Lisa Eminhizer
QA Officer:Kristin Beckley
Field Service Manager: Eric Corson
Field QA/QC Manager: Dave Balkenbush
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Management meetings are held periodically,with all available managers, as needed. Items
discussed include any variety of topics to help with the day-to-day operations of H&P. These
meetings are not mandatory and provide an informal discussion of managerial duties. Records of
these meetings, including list of attendees, topics discussed, and action items are kept by Louise
Adams. Copies of these meetings are kept on the H&P server in the management folder.
2.2 Company Organization
Other company responsibilities are assigned as follows:
Project Managers: Louise Adams, Suzie Nawikas, Kristin Beckley, Scott Mayfield
Sample Custodian:Tori Unsworth and various field & company personnel
Logistics/Lab Assistant:Tori Unsworth
Technical Services Manager: Dave Balkenbush
Document Control Officer: Noah Unsworth
Deputy Laboratory Director: Thu Nguyen
LIMS and IT Manager: Noah Unsworth
Purchasing Manager: Therese Torres
Office Manager: Noah Unsworth
Safety responsibilities are assigned as follows:
Health & Safety Officer: Dave Balkenbush
A company organization chart is outlined in Figure 2.2.
2.3 Personnel
Specific Job Descriptions/Responsibilities and Minimum Qualifications.
These requirements apply to all full-time, part-time, permanent, and temporarily assigned
personnel.
Quality Assurance Officer (QA Officer):
Responsibilities of the QA Officer include:
Serving as the focal point for QA/QC and be responsible for the oversight and review of
quality control data.
Have functions independent from laboratory operation for which they have quality
assurance oversight.
Be able to evaluate data objectively and perform assessments without outside managerial
influence.
Have documented training and or experience in QA/QC procedures and be knowledgeable
in the quality systems defined under ELAP, DoD, NELAP and ISO 17025:2017.
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Have a general knowledge of the analytical test methods for which data review is
performed.
Arrange for or conduct internal audits on the entire technical operation annually.
Notify laboratory management of deficiencies in the quality system and monitor corrective
action.
Assist with the updating and review of the QSM and related SOPs
Assuring that data meets the requirements of the NELAC, DoD, ELAP and ISO/IEC
17025:2017 Standards under which the lab performs the analyses including but not limited
to this QSM.
Direction of laboratory personnel in QA/QC issues
Minimum Requirements:
Bachelor’s degree in related science and 10 years’ experience in analytical chemistry
techniques including 5 years performing QA/QC functions
Laboratory Director:
The laboratory director is responsible for all aspects of laboratory operation from a scientific and
technical standpoint. This involves:
Direction of laboratory personnel and processes, including hiring of qualified personnel.
Training and certification of laboratory personnel
Assisting the project manager in the scheduling of equipment and labor.
Technical analysis of projects to assure that correct methods and procedures are applied to
samples.
Resolution of "out-of-control" events.
Monitoring standards of performance in quality control and quality assurance.
Monitoring the validity of analyses performed and data generated in the laboratory to
assure reliable data.
Assuring that data meet the requirements of the NELAC, DoD, ELAP and ISO/IEC
17025:2005 Standards under which the lab performs the analyses including but not limited
to this QSM.
Update and review the QSM and related SOPs
Minimum Requirements:
Bachelor’s degree in chemical, environmental, biological science, physical science or engineering,
with at least 24 college semester credit hours in chemistry and at least ten years of experience in
the environmental analysis of representative inorganic or organic analytes for which the laboratory
seeks or maintains accreditation. Supervisory experience is preferred. A master’s degree or
doctoral degree may substitute for one year of experience.
Should the laboratory director be absent from the lab for more than 15 days, management will
select a temporary director to assume the responsibilities above. The person chosen must meet the
full requirements of the laboratory director position. If the laboratory director will be absent for
more than 35 consecutive calendar days, the primary accrediting authority CA ELAP, NELAC and
DoD (PJLA)will be advised of that fact.
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Project Manager:
The project manager is responsible for the communication and the scheduling of all fixed base
laboratory work and all field work for the chemists and technicians. The project manager is also
the main contact with client project managers and has the responsibility to clarify client requests,
plan appropriate work to meet those requests and to receive feedback from the client both positive
and negative concerning the analyses performed. These responsibilities include:
Providing cost estimates to clients.
Scheduling of equipment and labor.
Assisting the president with work plans.
Managing field work
Tracking deliverables.
Analyzing feedback to ensure proper response to client. Documenting feedback by
informing the employee(s) and their supervisors of the feedback. This information may be
provided by email.
Maintain a list of subcontract laboratories which meet various Quality Standards and/or
maintain specific accreditations (e.g., NELAP and/or DOD etc.)
Minimum Requirements:
High school diploma or equivalent. Bachelor’s degree in science or 3 years related job experience
preferred.
Field Services Manager:
The Field Services Manager is responsible for overseeing all field sampling activities and
personnel. This includes:
Direction of all field personnel (excluding chemists) and procedures, including hiring of all
qualified personnel.
Oversee training of personnel (including chemists) for all field sampling procedures.
Assist the project manager in the scheduling of field equipment and labor.
Technical analysis of projects to assure that correct methods and procedures are applied to
sample collection.
Responsible for the development of field sampling procedures as well as developing and
validating new methods
Review of all field sample collection documentation.
Assist Field QA/QC Manager with monitoring standards of performance for sample
collection procedures.
Maintaining field equipment and instrumentation.
Minimum requirements:
At least 5 years related job experience with direct push drilling and environmental field sampling.
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Field QA/QC Manager:
The Field Services QA/QC Manager is responsible for overseeing all the quality assurance
associated with field sampling. This includes:
Maintain and update field sampling SOPs.
Assist the Field Services Manager with the development of field sampling procedures as
well as developing and validating new methods
Review field sample collection documentation, if needed.
Monitoring standards of performance for sample collection procedures.
Maintaining field instrumentation, including obtaining professional calibrations of meters.
Acting as qualifying employee for company C57 license.
Assuring that field sample collection activities meet the requirements of the NEFAP, DoD,
and ISO/IEC 17025:2017 Standards under which the company performs these activities
including, but not limited to, this QSM.
Minimum requirements:
At least 5 years related job experience with direct push drilling and environmental field sampling.
Technical Services/Health & Safety Manager:
The Technical Services/Health & Safety Manager is responsible for the maintenance and repairs
of all H&P’s equipment, vehicles, and sampling equipment excluding laboratory instrumentation.
In addition, he/she is responsible for ensuring that H&P Mobile Geochemistry Inc.'s safety
practices and programs are maintained including general laboratory safety, safety requirements for
equipment operation and for chemical handling and storage. These responsibilities include:
Ensures that the summa canister inventory is sufficient and acceptable for client’s samples
by preforming or subletting repairs in according to H&P’s specifications and updating
H&P summa canister inventory accordingly.
Manages all vehicle maintenance and repairs including mobile laboratories, drill rigs and
field sampling trucks. Other equipment includes rig hydraulics and hammers, generators,
back-up cameras and Navman systems.
Updates Navman fleet maintenance schedule and vehicle maintenance logs as required.
Ensures all field and laboratory personnel are provided with all required safety equipment.
Ensures all field and laboratory personnel follow H&P’s Safety practices through audits
and Safety meetings.
Manages all safety training and ensures that field/lab employees are kept up to date and
their safety certifications are maintained and tracked.
Ensures all client required Safety programs and protocols are completed and up to date.
Manages all employee’s medical surveillances and ensures that they are kept up to date and
reviewed for physical limitations or other health issues that may affect performance.
Manages all wastes and ensures that H&P is in compliance with CERS.
Manages annual CERS reporting.
Represents H&P as the Hazardous Material Shipper and ensures that the certificate is
renewed every 3 years.
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Maintains H&P’s hazardous Materials Business Plan and Emergency Response Plan is
reviewed annually and maintained. This includes a responsibility to provide training
annual training to meet these objectives.
Acts as qualifying employee for company C57 License.
Assists Field Services Manager to assure that field sample collection activities meet the
requirements of the NEFAP, DoD, and ISO/IEC 17025:2005 standards under which the
company performs.
Auditor (Internal):
Internal audits are typically performed by the laboratory director, QA Officer, Field Services
Manager or Field QA/QC Manager. It is appropriate for a scheduled internal audit to be
delegated to another employee if they meet the following requirements:
Knowledgeable in the area being audited as to the requirements, criteria, and procedures
Knowledgeable and trained in the audit process.
Minimum Requirements: At least 2 years of experience in the procedures being audited.
Office,Human Resources and Purchasing Managers –
The responsibilities of this position may be divided between several individual.Together, they
will be responsible for all human resource, office and accounting functions which include:
Assure compliance with State and Federal employment laws, EDD programs, workers
compensation, OSHA and COBRA.
Handle all accounting functions such as payroll, accounts receivable and accounts payable.
Ensure that orders are placed through approved vendors according to DoD and ISO/IEC
17025:2005 2017 requirements.
Assist Operations Manager with recruiting tasks checking references and driver records,
and drug testing.
Schedule office repairs and building maintenance as needed.
Minimum requirements:
Bachelor’s degree in business, accounting and/or human resources management preferred or at
least 3 years related job experience.
LIMS and IT Manager:
Maintain Server which includes Cloud backup, user permissions, remote control access,
anti-virus updates, Window server updates, installing new software, defragmenting hard
drive, and to troubleshooting errors.
Maintain Element LIMS including database archiving/backups, user permissions, audit
trail, Element updates, report format revisions, EDD generation, and troubleshooting
errors.
Maintain lab computers and printers which includes the setup of new computers, installing
instrument software, Window updates, anti-virus updates, network server connections,
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mobile lab Internet access, and troubleshooting computer and printer error or replace faulty
hardware if necessary.
Manage IT inventory and supplies which includes spare computers, printers, cables and
accessories.
Minimum requirements:
Bachelor’s degree and/or at least 3-5 years related job experience.
Document Control Officer:
The document control officer functions to maintain the technical records for the company.
Responsibilities of the Document Control Officer include:
Maintenance of records concerning reports, quality control information, instrument logs,
extraction logs, etc.
Maintenance of electronic records of instrument data.
Minimum Requirements:
Bachelor’s degree or related experience
Report Signatory Personnel:
The Laboratory Director and/or QA/QC Officer will determine those employees who have the
training and experience to sign and issue reports. The laboratory director will inform all members
of the company in memo form of the names and hierarchy of signatory personnel. Personnel
signing reports will perform a final review prior to signing the report.
An electronic signature may be used to sign reports; however, it may not be a computer-generated
signature. The electronic signature must be a scan of the real signature of the person signing the
report. The electronic signatures are to be kept only by approved report signatory personnel and
the document control officer.
Minimum Requirements:
Bachelor’s degree in science or related discipline and at least two years’ experience in organic
analysis.
Sample Custodian:
The sample custodian is responsible for all phases involved with the receipt of samples. The duties
of the sample custodian are:
Receive samples
Unpack and verify labels
Inspect for damage, and other irregularities including proper documentation.
Report problems to Lab Director and Project Manager as necessary
Complete sample chain-of-custody documentation
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Place samples in storage area
Log in samples
Log into tracking system
Generate internal tracking forms
Notify managers and analysts
Dispose of unused sample at the appropriate time
Dispose of extracts at appropriate time
Assemble all related documents into a case file
Minimum Requirements:
High School diploma or equivalent
Data Reviewer:
The functions of the data reviewer are:
Assemble Data
Tracking database
Lab Prep
Various analysis from all labs
Verify data completeness
Verify compliance with QA/QC requirements
Verify compliance with client requirements
Create LIMS report
Compose project summary narrative
Technical difficulties
QA/QC results
Conclusions
Produce final report
Compile
Duplicate
Transmit to client
Minimum Requirements:
Bachelor’s degree in science or related discipline, a good understanding of the method being
reviewed, or related job experience.
Chemist/Analyst – Mobile Laboratory/In-House:
The functions of the chemist are:
Preparation and analysis of environmental samples including but not limited to soil, water
and soil vapor. Chemists may also be assigned vapor sample collection.
Maintenance and operation of the equipment used in the analysis of environmental
samples.
Remain knowledgeable of current QSM, SOPs and QA/QC requirements of the job.
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Review and interpretation of data.
Preparation of preliminary drafts of customer reports and case data packages for the data
reviewer.
Acceptance of samples under proper procedures (for mobile lab chemists).
Interface with client on site to provide analytical chemistry consultation (mobile lab
chemists.
Mobile Lab Chemists are considered mid-level supervisors in GC and/or GC/MS
techniques.
Minimum Requirements:
For in house laboratory:
Bachelor’s or Associate’s degree in science or related discipline, or related job experience.
For mobile laboratory:
Bachelor’s or Associate’s degree in science or related discipline is preferred. In lieu of a degree,
appropriate, thorough training or experience is acceptable.
Field Sample Technician:
The functions of the strataprobe operator and field technician are:
Understanding and proficiency in the collection of environmental samples including, but
not limited to, soil sampling, ground water sampling, indoor air sampling and soil vapor
sampling.
Maintenance and operation of the equipment used for the collection of environmental
samples.
Accurate documentation of field collection data.
Knowledge in the proper handling and transport of environmental samples.
Interface with the client in the field to provide field sampling consultation.
Minimum requirements:
High School diploma with 1-2 years’ environmental field sampling experience preferred.
Temporary or Part Time Duty Assignments:
Laboratory Director
In the absence of the laboratory director, the most senior Chemist will serve as the technical
director assuming he/she meets the minimum requirements of the technical director position (see
above under “Laboratory Director”). This person is called the Deputy Lab Director.
Quality Assurance Officer
In the absence of the QA Officer, the most senior data review Chemist will serve as the QA
Officer assuming that person meets the minimum requirements of the QAO position.
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Chemist/Analyst
Temporary assignments are only acceptable for in-house chemists. Mobile laboratory chemists
require a significant amount of safety training and cannot be closely monitored as an in-house
chemist. The requirements for a temporary in-house chemist are the same as a permanent in-house
chemist. They must also undergo training and must demonstrate their proficiency in the analysis
they are to perform before they are allowed to work on client samples.Part-time analyst/chemist
positions do not require a completed bachelor’s/associates degree as long as they are closely
supervised by a senior chemist or the laboratory director.
Field Services Manager and Field QA/QC Manager
In the absence of the Field Services Manager or the Field QA/QC Manager, the most senior
Strataprobe operator/field technician will serve as the field sampling director- assuming he/she
meets the requirements of the position (see above under “Field Services Manager Operations and
Field QA/QC Manager”).
2.4 Personnel Training
2.4.1 Technical Training
All technical employees must undergo training in the use and application of new methods,
techniques and equipment. It is the responsibility of the Laboratory Director, Field
Services Manager and/or Field QA/QC Manager to see that appropriate training is
provided and to test the effectiveness of the training. At no time, will this training activity
involve generation of customer data or the collection of client samples unless it is under
the direct supervision of an instructor. Data generated in the training programs are to be
reviewed immediately and any problems identified corrected by the trainee. No analyst or
technician will be permitted to perform analysis or sampling operations until he/she has
demonstrated the ability to correctly collect samples or produce accurate and precise data
as well as to correctly maintain the required documentation. As part of their training all
new employees are required to review, understand and implement the SOP designated by
H&P prior to the end of their training period. The Laboratory Director, Field Services
Manager and/or Field QA/QC Manager will maintain records to show that the analyst or
technician have been certified as properly trained.
For an analyst, initial training involves a demonstration of initial capability, which includes
a reproducibility study. A reproducibility study is performed by the analyst analyzing 4
replicates of a blank spike prepared at a concentration that is at the mid-point or lower.
The %RSD is calculated for each analyte using the following formula:
%RSD = (STD/A) *100
Where… %RSD = % Relative Standard Deviation
STD = The standard deviation of the 4 replicates for each analyte
A= The average of the 4 replicates
The %RSD determined must be at or below the % precision requirements for the method.
In addition, the % Recovery is calculated for each analyte using the following formula:
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% Recovery = (A/TV) *100
TV = true value of analyte’s spiked concentration
A Demonstration of Initial Capability and associated Reproducibility Studies are kept on
file for each chemist (Appendix 2A).
Each analyst must demonstrate his or her proficiency annually by successfully analyzing a
Performance Evaluation (PT) sample every year and/or by successfully completing an
intra-laboratory study every year. The chemist must achieve an acceptable result on 80% or
greater in order to demonstrate performance in the method. If PTs are not available or if an
intra-laboratory study is not possible, a reproducibility study may be performed. The
chemist must demonstrate that their precision and accuracy meet method requirements.
(Appendix 2B – Demonstration of Continuing Proficiency)
For a field sampling technician (mobile lab chemists are considered field sampling
technicians as well), initial training involves a demonstration of initial capability, which
includes a field sampling audit to be observed by the Field Services Manager and/or Field
QA/QC Manager or qualified senior field technician. This audit will include all the
necessary sampling tasks for the proper collection of soil vapor samples. Some of these
tasks include: Collection of soil vapor samples using a glass syringe sample container,
collection of soil vapor samples using a summa canister sample container, and collection
of soil vapor samples using a summa canister in conjunction with helium shroud leak
detection. Each person must show proficiency in any task they are to perform in order to
begin collecting samples on their own.(Appendix 2A2)
Each field sampling technician must also demonstrate his/her proficiency annually by
being observed by the Field Services Manager, Field QA/QC Manager, or a qualified
senior field technician while conducting these sampling tasks. This may be done onsite
while field operations are being performed or simulated at the in-house facility.(Appendix
2B2)
As part of the continuing proficiency, the sample technician must also demonstrate his or
her proficiency in vapor sample collection by successfully collecting a Performance
Evaluation (PT) sample. This is accomplished by following H&P soil vapor sample
procedures to pull vapors from mock soil vapor probe attached to a 6L summa containing a
certified VOC standard prepared by the lab. The sample technician must achieve an
acceptable result of 80% or greater in order to demonstrate performance in soil vapor
sample collection. (SOPS 007) This may be done onsite while field operations are being
performed or simulated at the in-house facility.
H&P is committed to using the newest and most reliable techniques in sample collection
and analysis. To accomplish this, new and better sampling and analytical procedures are
continually being developed. All technical personnel receive training in these new
protocols once established and a SOP is developed and distributed. In addition, as part of
H&P’s on-going training, when changes or additions are made to the SOPs, the previous
SOP is removed from the server and replaced with the revised copy.In addition, a
summary of any changes made to the SOP from the previous year are summarized at
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the end of the SOP.The employee then reviews the updated SOP. The Field QA/QC
Manager shall maintain documentation of the SOP distribution.
Company technical training staff:
Laboratory Director: Lisa Eminhizer
Deputy Laboratory Director:Thu Nguyen
Field Services Manager: Eric Corson
Field QA/QC Manager:Dave Balkenbush
2.4.2 Ethical/Legal Training
All employees must undergo training in the legal and ethical responsibilities of
environmental sampling and analysis. Ethics training is performed during employee
orientation and on an annual basis. Attendance sheets are used for documentation of
Ethical training. Make up sessions will be provided for any employee that cannot make the
annual meeting. This training is to ensure that personnel are capable of providing quality
work that is not affected by outside influences. It is the responsibility of the President to
see that appropriate training is provided. H&P is in the business of providing
environmental sampling and analytical chemistry data. H&P will not become involved in
any activities that would diminish their impartiality, judgment, or integrity. We are subject
to rules, regulations, and guidelines etc., which emanate from many sources. Among these
are the various Federal, State and local agencies that have access to and receive our data.
We must also be sensitive to our clients’ requirements. It is our policy that data is
presented objectively, without subjective or biased interpretation by the analyst or
reviewer. It is also our policy to provide full and adequate disclosure of the quality of the
data that we produce. In other words, quality control parameters are to be used to assess
data quality and should not be viewed as “pass/fail”, to be achieved at all costs. In
addition, when parameters are out of current SOP specifications, it is our policy to identify
that data which is affected and to offer probable or possible explanations in the form of a
narrative or data flags.
2.4.3 Safety Training
All technical field employees receive 1) 40-hour OSHA Training; 2) Annual 8-hour
Refresher course; 3) Defensive Driving Training; 4) API (American Petroleum Institute)
Worksafe Training; 5) CPR Training; and, 6) Annual Medical Surveillance OSHA
Examination and 7) Annual Respirator Fitness Certification. With the exception of
respirator certification, which is conducted by the Technical Services/Health & Safety
Manager, all other training is provided through certified third-party programs. In addition,
all chemists and field technicians may undergo site-specific training when requested by
clients, such as LPO certification.
Quarterly safety meetings are held which will cover a variety of safety topics for field staff
and bi-annual safety meetings are held for the fixed laboratory and office staff. The topics
covered will be selected by the Technical Services/Health & Safety Manager to cover areas
of concern in the daily operation of laboratories, drilling equipment, sampling equipment
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and office equipment. Signup sheets are circulated to document attendance. Make up
sessions will be provided for any employee that cannot make the quarterly meeting.
2.4.4 Computer Security Awareness Training
All employees must receive training on computer security by the LIMS & IT manager and
be made aware of how to protect H&P’s computers, LIMS and email systems from
security breaks or hackers. Employees will be instructed as to the consequences of
computer security problems and be provided with instructions as to how to prevent these
issues. Computer security training is performed during employee probationary period and
on an annual basis.
2.5 Personnel Records
Records of the qualifications, training and experience performance evaluations of all analysts and
field technicians are maintained in the company administrative files. A master file of signatures
(Appendix 2C) for all employees is to be maintained by the Human Resources Manager for
reference. Employees are to be instructed that their initials and signature must be consistent to
what they will use in all H&P documentation.
3.0 FACILITIES, NEW METHODS AND EQUIPMENT PURCHASES
H&P operates fixed and mobile laboratories and field vehicles including strataprobe rigs and support
vehicles. The fixed facilities provide administrative support to all mobile laboratories.
All experimental data generating activities at H&P must operate in an environment that will not invalidate
the data produced. In general, laboratory test areas should have proper lighting, heating and cooling and
ventilation to facilitate proper performance. Care must be taken to ensure freedom from excessive dust,
electromagnetic interference, humidity and maintenance of sound and vibration levels. Work areas are to
be kept neat and unencumbered to facilitate analysis activities. Effective separation is to be maintained to
eliminate cross contamination (e.g., volatiles away from extraction solvents.) Access to work areas should
be controlled. If a test method specifies monitoring of environmental controls, then this must be
implemented as part of the QC procedures. Specific details on laboratory work environments and
monitoring controls are discussed in the following sections:
3.1 Laboratory Security
The purpose of this section is to describe the procedures used to secure the laboratory. It identifies
responsible parties and establishes the mechanism used to see that security is maintained.
3.1.1 Buildings
H&P’s office buildings have a security alarm system and commercial response company.
An entry code system is used for access after opening of the door and must be set at the
end of the day by the last person leaving. At no time should the building be left unattended
and unlocked. Outside lighting and cameras add to the overall security of the H&P
facilities.
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3.1.2 Mobile Laboratory Security
Mobile labs are not left unattended and unlocked when parked on customer sites. If the
operator needs to leave, a second party (the customer) must be made aware that the lab is
left unattended and should watch the vehicle.
When not in the field, mobile labs are parked in the indoor bay area of the fixed facility or
behind a locked gate.
3.1.3 Strataprobe and Field Vehicle Security
Field vehicles are typically stored outside the company facility. Strataprobe rigs and field
tech trucks are to be secured so that nothing of value can be easily accessed. All doors and
storage boxes are to be locked when the vehicle is left unattended.
In the event a field vehicle is stocked for the following day project with expensive
equipment, such as field instruments or meters, the vehicle must be parked overnight in the
warehouse.
3.2 Laboratory Management/Field Equipment Management
3.2.1 Mobile Laboratories
Each mobile laboratory is assigned a chemist to maintain the instruments, computer, and
the mobile lab itself. The following items are responsibilities of each chemist assigned a
mobile laboratory:
All instruments are tied securely to the counters as to not fall during mobilization.
All refrigerators are operating properly for sample and standard storage
All instruments are calibrated, and calibrations are valid.
All instruments are kept free from excessive dust and heat.
All instruments are properly maintained.
The generators are properly maintained and are working well
The outside and inside of the mobile laboratory are kept clean.
Maintenance is up to date on engine, tires, transmission etc
Computers are kept dust free, and data and methods backed up and deleted
The Laboratory Director, senior chemists and the Technical Services/Health & Safety
Manager are responsible for assisting each chemist with the above and will assist in
keeping the maintenance log up to date. The updated maintenance log will be sent to each
chemist after it is updated. Each mobile lab chemist will perform a vehicle inspection on
their mobile lab and complete a Mobile Lab Inspection Sheet (Appendix 3A) on a weekly
basis. Before mobilization to a job each chemist will check to ensure their lab is stocked
with all the items required to perform a job. Appendix 3B1 and 3B2 is a recommended
checklist.
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The environmental conditions of any field analysis are to be documented. Included in the
log record will be the date, site location, analyst/driver, test methods, sample matrix and
internal and external field conditions, including internal laboratory temperature, and
weather conditions. These conditions are recorded on the Mobile Lab Project Notes
(Appendix 9D1 & 9D2) the Excursion Log (Appendix 9C) and in the Chemist’s Run Log
(Appendix 9E-L).
The lab environment will be monitored for temperature by an internally mounted wall
thermometer. Initial acceptance limits for temperature will be set at 16-30 o Celsius (60 to
86 F). If the laboratory temperature is not maintained within this temperature range, the
laboratory director is to be contacted immediately.
Equipment utilized in the laboratories such as refrigerators, GCs, GC/MS, etc. are
monitored and recorded as specified in Section 4.0 and documented in the Excursion Log.
3.2.2 Fixed Base Laboratories
The fixed base laboratory is separated into areas for different analytical procedures, for
example, the EPA 8260 and GC area are separated from the EPA TO-15 area. These areas
are separated in order to minimize contamination and to provide enough area for each
analyst to work and prepare their samples for analysis. Each area has its own temperature
control unit which is to be monitored and kept in the acceptable temperature range for
analysis. The laboratory temperature is to be recorded onto the Chemist’s Run Log
(Appendix 9E-L). The following items are responsibilities of the chemist and/or lab
personnel assigned to the area:
All refrigerators, if present are operating properly for sample and standard storage
All instruments are calibrated, and calibrations are valid.
All instruments are kept free from excessive dust and heat.
All instruments are properly maintained.
The laboratory is to be kept clean and organized.
Computers are kept dust free, and data and methods backed up and deleted
Equipment utilized in the laboratories such as refrigerators, GCs, GC/MS, etc. are
monitored and recorded as specified in Section 4.0 and documented in the maintenance log
or refrigerator logs.
3.2.3 Strataprobe Rigs and Field Vehicles
Each Strataprobe rig and field vehicle is assigned to a primary operator who is responsible
for the maintenance of the vehicle and the equipment needed to perform their duties. The
following items are the responsibilities of each field technician assigned to a field vehicle:
All tooling is free from cracks, and threads are in good working order
Tooling on truck is properly stored and organized
Generator and power tools maintained and in good working order
All supplies necessary for required field activities stocked and organized
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The vehicle is kept clean on the inside and outside
Maintenance is up to date on the engine, tires, transmission, etc.
The Field Services Manager and Field QA/QC manager are responsible for assisting each
field technician with the above items and will keep the maintenance log up to date. The
maintenance log will be sent to each technician after it has been updated. Each technician
will perform a vehicle inspection on their vehicle and complete a Strataprobe Vehicle
Inspection Sheet or a Support Vehicle Inspection Sheet (Appendix 3E1 or 3E2) on a
weekly basis. Before mobilization to a job, each field technician will check to ensure their
vehicle is stocked with all the items required to perform the job.
Equipment Audits are also done on each Strataprobe rig and field vehicle at least once a
year to help maintain the proper amount of tooling and supplies on each vehicle. This
audit is performed by the Field Services Manager and/or Field QA/QC Manager or a senior
field technician (Appendix 3F & 3G).
3.2.4 Portable Field Instruments, Meters and Detectors
The use of portable analytical field meters and detectors are often required to perform
various analyses in the field. Examples of these instruments are: Landtec GEM 5000 Gas
Analyzer, and the Radio detection MGD 2002 Multi Gas Leak Detector. All field
instruments must meet the same criteria as in-house equipment which includes:
Documentation of yearly factory calibration. Instrumental information regarding
accuracy and precision is to be provided and checked to ensure that the analytical
requirements are met.
Each instrument must undergo a daily field calibration, before and after use, to
ensure instrument is within acceptable ranges.
Upon receiving any field instrument back from any repairs or calibrations, the
instrument will be tested and a calibration check is to be run to assure it is working
properly. This data will be kept in the instrument file folder kept by the Field
QA/QC Manager.
Daily calibration results are recorded on the specified sample log sheet.
The analyst or technician is to obtain training that is verified by the Lab Director or
the Field QA/QC Manager prior to field analysis.
Uncertainty budgets are maintained and reviewed yearly to provide uncertainty of
measurement and to establish trends of meters.
Once these conditions are met, analysis can proceed. All recorded data is to be kept in the
project file for the samples that were analyzed.
3.2.5 Rental Equipment
It may be necessary for H&P to obtain rental equipment to perform various analysis in the
field. Examples of rental equipment are Landtec meters, Helium meters, Hydrogen Sulfide
meters, PID meters, portable GCMSs or GCs. All rental equipment must meet the same
criteria as in-house equipment which includes:
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Must include documentation from the rental supplier that the instrument is
calibrated and in good condition. Instrumental information regarding accuracy and
precision is to be provided and checked to ensure that the analytical requirements
are met.
The analyst or technician is to obtain training that is verified by the Lab Director or
Field QA/QC Manager prior to field analysis.
The calibration must be validated prior to being used on client’s samples.
Forms must be available to record calibration and results.
Once these conditions are met, analysis can proceed. All recorded data is to be kept in the
project file for the samples that were analyzed. A copy of the rental documents is to be
maintained by H&P and kept on file as well.
3.3 Laboratory Equipment Changes
This section is to be followed if a newer model replaces analytical equipment or if the current or
new instrumentation is used for an alternative methodology than currently used in the individual
mobile laboratory. Any rental equipment or test instruments normally outside of H&Ps control
must be checked to ensure they meet the requirements. (See section 3.2.5). The laboratory
director, senior chemist, Field Services Manager and/or Field QA/QC Manager is required to
oversee these procedures.
When a new methodology is being developed, there is a mechanism that is to be followed to ensure
it is a marketable analysis that will meet client needs. The following steps are to be included in the
systematic approach to method development:
3.3.1 Market Evaluation (alternative methodology only) –
Primarily the project managers will do this as they obtain client requests for an analytical
method. Requests by regulators for a specific analytical method may also prompt interest
in developing a new technology. The president must approve this new technology to be
developed so that proper resources can be assigned.
3.3.2 Technical Research (alternative methodology only) –
Once the market need for this alternative analytical technology is confirmed, research may
proceed to determine the technical requirements such as analyte lists, required reporting
limits, sampling requirements, QA/QC requirements, and what matrices will be analyzed.
In addition, research should be done on what analytical instrumentation is necessary to
obtain that will meet these requirements once determined. This is to be evaluated by
laboratory director. An attempt is to be made to evaluate more than one vendor of such
instrumentation to ensure the wisest purchase is made. It must be verified that that the
instrument purchased will have the sensitivity, precision and accuracy required for the
method to be performed. Things to consider in an instrument purchase are: cost,
efficiency, ease of use, owner feedback, and reliability. The accessories such as sampling
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equipment, analytical columns, analytical standards, etc. are also to be determined and
evaluated.
3.3.3 Instrumental Set Up
Once the instrument is purchased it can be placed in a mobile laboratory or at the fixed
facility. The intended location is to be prepared for this instrument by:
Adding the required electrical outlets with the proper voltage and plug
configurations.
Setting up and securing the needed gas supplies such as helium, nitrogen, or air.
The instrument may require a water supply and/or a drain. There may also be a
need for cryogenics.
Setting up the computer and software will require access to the server and possibly
the Internet.
3.3.4 Instrumental Operating Conditions
After the instrument is delivered, it is recommended that the vendor, or someone
knowledgeable in its design, set the instrument up. The chemist or laboratory director
should be present during instrument installation so that all the necessary information to
operate, maintain, and calibrate the instrument is obtained from the installers. In most
cases, the installers will assist in the method development and set the parameters for the
specific analytes so the chemist can proceed to the next sections. It is also recommended
that a training session be scheduled so that the operating chemist will have some
knowledge of its operation. After setup, the vendor must demonstrate that the instrument
is fully functional. These steps are to be overseen by the laboratory director so that proper
instrumental setup and training is verified. All these records are to be kept with the
instrument.
After the chemist is trained and the instrument is set up, the chemist is to gain familiarity
with the instrument. Application notes offered by the vendor may provide a starting point
for analytical conditions that can be used to determine analytes of interest. All test results
must be kept and analytical conditions that were used, documented. Once acceptable
results are obtained, the chemist must demonstrate that the instrument meets the
requirements of the client’s standard and any other project or regulatory requirements that
exist.
The software must also be validated to show that it provides acceptable calculations
according to the method. (See Section 3.3.9 for more detail)
A standard operating procedure (SOP) is to be written and then reviewed by both the
laboratory director and the QA Officer.
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3.3.5 Demonstration of Capability and Method Validation
Before an instrument can be used on client samples, the laboratory must demonstrate that
the instrument and procedures used are capable of generating acceptable data. For more
detail on Method Validation, see Method Validation SOP, which provides details and steps
required for method development and annual method validation.
This section also applies to the analysts who may use the equipment and is covered in
more detail in the section on training. Proper demonstrations of capability include:
PT sample testing or other reference material testing
Intralaboratory comparison of results (if PTs are not available)
Precision and Accuracy studies`
Comparing results obtained from other validated methods
When the above techniques are not feasible, the following options must be used:
Systematic assessment of factors that could influence the result; and/or assessment of the
precision and bias of the result based on the science of the method and practical
experience.
3.3.6 Method Detection Limits and Reporting Limits
In addition to demonstrating the capability of an instrument and reading its Standard
Operating Procedure, the chemist must determine the instrument’s method detection limit
(MDL). This MDL study is performed according to the published procedure for
determining MDLs and/or outlined in the specific analytical method SOP or published
method. The MDL must be performed for each matrix to be analyzed. The MDL study
determines the detection limit (DL) that is the smallest quantity of a target that can be
differentiated from zero with a specified probability. Once this is determined, it is tested
by analysis of a clean matrix spiked at 2-4 times the estimated MDL to determine the limit
of detection (LOD). The LOD should be 2 to 4 times the MDL. All MDLs must be
validated by the Laboratory Director or QAQC Officer.
In addition to performing an MDL study and a LOD determination, the limit of
quantitation (LOQ) is to be verified. The analyst may choose a potential LOQ and
demonstrate its suitability by analysis of a spiked matrix. The analyst should spike each
matrix at 1 to 2 times the potential or set LOQ to determine if the instrument can report at
this level with the laboratories’ specified accuracy and precision. If the instrument cannot
reach the desired LOQ it may be necessary to alter the instrument or sample preparation
procedures to meet these requirements.The LOQ must be greater or equal to the LOD.If
the instrument can determine compounds present at the desired LOQ, the LOQ may be
used as a reporting limit within the requirements for accuracy and precision.All LODs and
LOQS must be validated by the Laboratory Director or QA/QC Officer. The forms used
for this are Calculation sheets CALC 005A through 005F. (See the Method Validation
SOP for more information.)
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The LOD and LOQ are to be validated on a quarterly basis and after a significant
instrument change. Examples of this are changing an analytical column or placing a new
auto sampler into service.
3.3.7 Modifications to Standard Methods
Some clients request that H&P add an analyte to the standard VOC list for either EPA
8260, H&P 8260 SV, H&P TO-15 or EPA TO-15. To be able to report this analyte there
are two choices:
1. To report the analyte as a Tentative Identified Analyte (TIC) and to estimate its
concentration and reporting limit or
2. To purchase the analyte and prepare a calibration for the analyte.
Regardless of how this new analyte is reported, the laboratory director is to oversee and
approve the process. Reporting an analyte as a TIC is not the most accurate procedure and
the analyte may not be successfully identified. Therefore, the client must be informed that
this approach is not the most desirable.
For TIC analysis, the mass assignments and the approximate retention time is to be
obtained from information sources. The analyst will then be instructed to scan for these
masses in the estimated retention time range. Library search techniques may be used on
any peak that has the masses to determine if it is the analyte. The software can be used to
estimate the concentration which can be hand-entered into element and flagged as a “TIC”.
For EPA 8260B or H&P 8260SV calibration, the analyte is to be prepared in methanol at a
concentration of 20 ppm or 200 ppm. If the analyte is not water soluble it can be assumed
that a 20-ppm solution will be acceptable. For water, soluble analytes, it may be more
appropriate to use a 200-ppm stock or higher. For TO-15 methods a vapor standard which
contains 1 ppmv of the analyte, must be purchased.
The analyst is to prepare a calibration curve using a minimum of 3-5 standard levels (see
specific method SOP requirements). The lowest calibration level will determine the
reporting limit to use in element. The calibration curve must be approved by either the
laboratory director or QAO prior to use. Since MDL or LOD studies are not performed on
this analyte, it is not acceptable to report below the RL. The client is to be informed that
this analyte is not on H&P’s standard list and that it is not routinely analyzed for.
3.3.8 Data Reporting
After completing the above sections, a method is to be created in the Element LIMS
system that will be used for reporting client sample results using the method detection limit
and reporting limit study results obtained. The method should also include any surrogates
used and the QA/QC criteria set for in the applicable EPA, DTSC, ASTM method or SOP.
The method is to be created in the proper department, TO, GC/MS or GC. The full analyte
list is to be added to the method, along with the MDL and reporting limits. The units in the
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Element database must coincide with the units used in the Chemstation or Peaksimple
method. If new analytes are created in the static tables, their molecular weights are to be
added as well. The cross tables are to be set up in Datatool so that the data can be
successfully merged with Chemstation.
3.3.9 Software Validation
New software obtained for analytical data processing must be validated prior to use on
client’s samples. This can be done by performing a hand calculation of an analyte and
verifying that the software provides the same value. These records are to be kept available
for review.
For instruments that have been in use but are having the version of software updated,
validation is also required. This can be done by reprocessing a blank and a standard to
verify proper results are obtained. These records are to be kept available for review.
4.0 SUPPLIES & EQUIPMENT CHECKS & MAINTENANCE
Equipment, materials and supplies that are necessary to complete analytical testing,as well as
environmental field sampling, are provided by H&P. The purchase of materials, equipment and supplies
which impact data and sampling quality is to be accomplished in such a way that a preset of defined
quality and/or performance specifications is included as part of the bid package. The standards for
equipment, supplies and materials are established based on the current regulatory requirements, industry
standards and lab certification requirements established by ELAP and other certifying agencies. The
supplier must meet the defined quality and/or performance specifications before H&P will
purchase/accept any materials, equipment or supplies. Where possible, all reference materials, reagents,
solvents and gases are to be obtained from vendors that are ISO/IEC 17025:2005 certified. Approved
vendors for laboratory equipment and supplies are listed in Appendix 7B1.Approved vendors for field
sampling equipment and supplies are listed in Appendix 7B2.
Once performance specifications have been met, supplies are to be dated and equipment labeled. When
possible, the date is to be written on the item itself. If the item has a useful shelf life it should also be
noted.Records of services and supplies should include but not be limited to:
Date of receipt
Expiration date (if Applicable)
Source
Lot or serial number
Calibration and verification records; and
Certifications by the manufacturer
The laboratory director is responsible for maintaining the Approved Vendor List for laboratory equipment
and supplies. The Field Services Manager and/or Field QA/QC Manager, and QA/QC Officer are
responsible for maintaining the Approved Vendor List for field sampling equipment and supplies. If the
vendors are required to be ISO/IEC 17025:2017 certified, this must be verified annually.
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4.1 Laboratory Supplies
4.1.1 Solvents
This section defines the purity specifications for organic solvents used in extracting
chemicals from various sample media and for glassware cleaning. Logbooks tracking
stock solutions and standard preparation are maintained at the Carlsbad Facility. All
solvents used must be identified by date of receipt, expiration date, lot number and
certifications (if any).
Extraction Solvents
All solvents used for organic analysis should be “distilled in glass” grade (for extractions)
or “purge and trap” grade (for P&T) or equivalent. The purity of solvents as extraction
solvents or purge and trap solvents should be evaluated using the "Blank Test".
Blank Test
The Blank Test involves using the solvent to prepare a laboratory reagent blank and then
analyzing it to demonstrate that any impurities present in the solvent will not interfere with
the target analytes. The maximum amount of any target analyte in a reagent blank should
Not be higher than the reporting limit (dilution factors taken into account) in effect
at the time
Not exceed a concentration greater than 1/10 of the measured concentration of any
sample in the associated batch
Not exceed the concentration present in any sample and is greater than 1/10 of the
specified regulatory limit
If a contamination problem is present, the source of contamination will be investigated and
measures taken to correct, minimize or eliminate the problem.
When the Blank Test is used, the solvent tested is deemed acceptable only for the analysis
situation evaluated and records are kept to this effect.
Washing and Cleaning Solvents
Technical grade solvents may be purchased and used for washing without performance
specifications.
4.1.2 Standards
This section establishes the criteria for acceptable materials for use as calibration
standards. The program is designed and operated to ensure that, when applicable,
measurements made by the laboratory are traceable to national standards of measurement
where available. The ordering of all reagents and standards is to be approved by the
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laboratory director. Upon receipt, the receipt date is to be written on the container. All
standards are to be placed in the proper area in the standards freezer.
The laboratory maintains calibration certificates that indicate the traceability to national
standards of measurement and the uncertainty of the measurement.
Analytical Standards
In-House Standards
Standards used in the calibration of analytical instruments that are prepared in-house are
prepared from neat materials or compounds. They are weighed to three significant figures
on an analytical balance or measured by a volumetric glass syringe and dissolved in an
appropriate solvent. Solvent volume is established using Class A volumetric glassware at
the specified temperature. Materials are considered neat if:
The purity as specified by the supplier is >99%,
Chromatographic analysis using a non-specific detector (GC-FID or HPLC-UV) shows
less than a 1% total impurity.
Out-of-House Standards (Purchased)
Standards purchased from suppliers are utilized as received. Crosschecking is achieved
using a similar standard from a second supplier. Not all standards require a second source.
These include TPH for gasoline in 8260 analysis and fixed gases, helium and methane. In
addition, analytes that are not reported on the standard H&P reporting list do not require
second source validation. For EPA Method 8260, H&P 8260SVand EPA TO-15 analysis
the calibration curve is created using one source and validated using a second source prior
to analyzing client samples. The prepared working standards are to be verified against the
old calibration curve. The standard validation data is maintained by the laboratory director.
All standards used must be assigned a unique ID number, and identified by date of receipt,
expiration date, lot number and certifications.
The procedures used for standard preparation are presented in each method SOP. All
preparations are to be documented in blue ink in the standard prep log books kept at the
Carlsbad facility. The conventions used for unique ID#s for EPA 8260 standards are: LP
standards are assigned to standards purchased directly from the vendor. LS standards are
mid-concentration stocks used to prepare LSS working stock solutions. The LSS working
stocks are used for calibration curve preparation. For TO-15 standards, AIS standards are
used to classify internal and surrogate standards and ACC standards are used to classify
VOC standard preparations. All preparations are to labeled with ID#, name and expiration
date. In the log books the documentation must include:
Preparation date
Unique ID # assigned
Name of standard and concentration of analytes within
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Volume, lot# and ID# of all solutions used to prepare standard along with their
expiration dates
Expiration date
Initials of person preparing standard
Summa Can # used for TO-15 and TO-14 standard preparations
The expiration dates for standards are determined as follows:
The opened LP vials are allowed to keep the vendor expiration dates as long as they
are properly sealed and kept per vendor specifications. The exception is with
gaseous 8260 standards which must be discarded once opened and used to make
standards.
LS primary source standards are given 6-month expiration dates unless they are
gaseous which are given 1-month expiration dates.
LSS working stock standards are given 3 months unless they are gaseous which are
given 1-month expiration dates.
4.1.3 Water
Clean water is used as a method blank for every analysis that is performed for water
matrices. The water that can be used for this purpose is bottled drinking water that is
typically free of VOCs and other target analytes. At times, it may be required for the
analyst to purge the drinking water with nitrogen gas for 5 –10 minutes prior to use if low
level target analytes are found in the method blank prepared with this water.
Other uses for water are for the Tekmar’s Solatek auto samplers which are used in
conjunction with the Tekmar concentrators. The Solateks are equipped with a large water
tank that must be kept full of water. The only water type suitable for this is distilled water.
Drinking and deionized water are not suitable.
4.1.4 Reagents
Some methods may require other reagents to be used in the sample preparation of in the
analysis. These chemicals are to be purchased at the same grade that is recommended in
the main EPA or ASTM method. If the method is not a standard method or the purity of
the reagent is not specified, “reagent grade” is to be ordered.The vendor must supply
certificates of analysis for every lot number delivered.
4.1.5 VOA Vials
Volatile Organic Analysis (VOA) vials are used for 8260 analyses and for TPH
extractions. The vials used for 8260 are 40 ml size and must have septa style caps. These
vials are typically baked before use with the caps removed at 200o C for 10 minutes due to
low level contamination. The vials for TPH extractions are 40 ml size for soils or 60 ml
size for waters and have solid caps. Vendors that supply these must be approved and their
vials tested before used on client samples. Acceptance is based upon acceptable
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contamination levels, sample size, cost and compatibility with the Solatek auto samplers.
The vendor must supply certificates of analysis for every lot number delivered.
4.1.6 Tedlar bags
Tedlar bags are used to collect samples for H&P TO-14, methane, fixed gases, helium and
H&P 8260SV analyses as wells as to perform some dilutions for H&P TO-15 analyses.
H&P uses a variety of sizes but the 500-cc size is the most regularly used size. Tedlars can
be made from different materials than “Tedlar” but these are not recommended as they can
easily split during storage or shipment. Vendors that supply these must be approved and
their bags tested before used on client samples. Acceptance is based upon contamination
levels, storage stability, strength and cost.
4.1.7 High Pressure and Cryogenic gases
High pressure gases are used in the operation of the gas chromatographs either as a carrier
gas, for or for the operation of the detectors and autosamplers. These include helium,
nitrogen, hydrogen and air. It is required that all carrier and purge high pressure gases are
high purity as they can cause problems during analysis if they have contamination. All
carrier and purge gases, such as nitrogen and helium, must come with a certificate of
analysis from the vendor. It is the responsibility of the analyst to obtain this certificate and
to provide it to the laboratory director as documentation that the lot they are using is
certified. The analyst is to date and initial this certificate.
Cryogenic nitrogen gases is used for TO-15 autosamplers which use them to focus
analytes prior to injection. These include liquid CO2 and liquid N2. These do not require
certificates of analysis since they must be of high purity.
4.2 Equipment Maintenance & Checks
Equipment that has been subjected to overloading or mishandling or otherwise thought to be
defective is taken out of service until the appropriate measures/repairs are completed and the
instrument has been tested and calibrated to perform satisfactorily.If any equipment is found to be
malfunctioning or unable to meet the specifications required in a method, it is to be taken out of
service until repaired.
Preventive maintenance procedures are listed in the maintenance and operating manuals for each
instrument. These are available on the server and are to be used to determine the frequency and
type of maintenance to be performed. All activities are to be documented in the maintenance log
book assigned to the instrument. All maintenance logbooks must be assigned a unique ID# and be
identified with vendor, model# and serial # of the instrument it applies to. All entries in the
maintenance log book must be initialed and dated by the person completing or witnessing the
activity. Analysts are also responsible for recording the maintenance completed by a service
contactor on their instrument.Examples of maintenance items to be entered into maintenance
logbooks are source cleaning, pump oil change, column maintenance, such as clipping the
column or changing the column. Note that all column information, including column type
and serial number, should be entered in the maintenance log.
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H&P also has a variety of support equipment that is used. The support equipment performance
checks and acceptance criteria is set forth in Appendix 4D to this QSM.
4.2.1 Gas Chromatographs (GC)
This section identifies the procedures associated with scheduled and unscheduled, and
daily, routine and non-routine GC maintenance.
Daily Operational Check
The following steps are to be followed by each instrument operator on a daily basis:
Check and replace the injection port septum if necessary. Injection septa typically
lasts for 50 injections. The injection liner should be evaluated and may also need to
be replaced if dirty samples have been analyzed.
Check GC column fittings to be sure they are secure. A leak check solution
(SNOOP) may be used on units other than purge and trap units. An electronic leak
detector may also be used.
Check injector, column and detector temperatures for proper settings for the
particular method; adjust as necessary.
Check gas cylinders for content and pressure. A gas chromatograph must have at least 60
psi set on the delivery pressure or second stage on the carrier pressure regulator. Change or
adjust as necessary. Any change in carrier or purge gases must be documented in the
instrument maintenance logbook.
Biannual Maintenance
The first working days of January and July, or as close as feasible, will be the time
designated for biannual maintenance. Instrument preventive maintenance will take place
on or around these dates if it is due. Completion of maintenance will be recorded in the
instrument logbooks.
Unscheduled Maintenance
Unscheduled maintenance includes all activities not addressed in the preventative
maintenance. It includes cleaning detectors and injectors, replacing gas cylinders, and any
activities that require dismantling any portion of the instrument except for GC column
replacement. It is usually undertaken when the instrument fails to perform acceptably. The
activities involved may or may not be routine in nature. When they are non-routine,
consult the manufacturer’s instrument manual and take the action indicated.
4.2.2 GC/MS
The purpose of this section is to identify routine procedures associated with scheduled and
unscheduled operation and maintenance of GC/MS.
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Daily Operational Check
The following steps are to be followed by each instrument operator on a daily basis:
Inspect and replace as needed the injection port septum.
Check GC column fittings to be sure they are secure.
Check the injector, column and ion source temperature.
Check gas cylinders for pressure and content. Adjust or replace as necessary.Any
change in carrier or purge gases must be documented.
Check gas flow rates by monitoring of retention times; adjust as necessary.
Check vacuum gauges for proper vacuum. Take corrective action if unacceptable.
GC/MS rough vacuum gauges are instrument specific and vary with ambient
temperature. Any deviation of more than +/- 5 millitorr may indicate a problem.
Monthly Instrument Check
On the first working day of each calendar month, the first instrument operator to use a
GC/MS should do the following:
Check the oil level in the mechanical pumps; add as required.
Give the instrument a complete visual inspection for problems.
Remove dust from rear and top of instrument and around cooling slits and fans.
Biannual Maintenance
On the first working days of January and July, or as close as feasible, perform preventive
maintenance not previously done. Indicate completion in the instrument logbook.
Unscheduled Maintenance
Unscheduled maintenance includes all activities not addressed in the sections above. It
includes cleaning ion sources, replacing rough pump oil, and any activity that requires
breaking vacuum except GC column replacement. It is usually undertaken when the
instrument fails to perform acceptably. The activities involved may or may not be routine
in nature. When they are non-routine consult the manufacturer’s instrument manual and
take the action indicated. Record all activities in the Log along with name and date. The
log should include the name of the piece of equipment, manufacturer’s model, a unique
identifier, details of maintenance carried out to date and a history of any damage,
malfunctioning and modification or repair.
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4.2.3 Balance, Top loaders and Weights
The purpose of this section is to identify the procedures associated with the scheduled and
unscheduled maintenance of balances and top loaders.
Operational Check
The following steps are to be followed by each user prior to each series of weight
recordings:
1. Tare the balance and place an ASTM Class 3 standard weight on it to verify that it
reads correctly. Note:Do not touch weight with bare hands, always use gloves or
forceps to handle weights.
2. Record the weight(s) on the analytical run log. (Appendix 9E-N) For DoD
accredited laboratories, two analytical weights that encompass the target weight
must be checked and recorded.One of the weights should include the weight of
the VOA vial, solvent (water or methanol) and the soil sample aliquot.
3. Sign and date the log.
4.Notify the Laboratory Director if the balance is not within its acceptance weight
error of +/- 2%.
Annual Maintenance
Every 12 months check the laboratory weight used to check each balance or top loader
against an NIST Standard Class 1. Record results in the Analytical Weight Calibration
Check Form (Appendix 4A).
Unscheduled Maintenance
Unscheduled maintenance includes all activities not addressed in the section above. The
activities involved may or may not be routine in nature. When they are non-routine consult
the
manufacturer’s instrument manual and take the action indicated. Record all maintenance
activities in the Log along with name and date.
4.2.4 Refrigerators
The purpose of this section is to identify the procedures associated with the scheduled and
unscheduled refrigerator maintenance.
Daily Operational Check
Once per day the Logistics/Lab Assistant Lab QA Monitor or analyst is to:
1. Read the temperature (Centigrade) on each refrigerator's thermometer. If there is a
correction factor on the thermometer, apply it to the reading.Both the uncorrected
and corrected temperatures are recorded.
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2. Record it in the Daily Refrigerator/Freezer QA Log (Appendix 9A &B) or
Excursion Log. (Appendix 9C)or Run Logs (Appendix 9C through N).
3.Initial and date the log.
If the reading on any refrigerator is outside its acceptance range, the QA Officer or
Laboratory Director is to be notified immediately and corrective action taken. If the
temperature is 3oC +/-3oC, the unit is functioning properly.
The refrigerators in the mobile laboratories that hold either client samples or VOC
standards, must also be monitored on a daily basis. The temperatures are to be recorded
onto the excursion log (Appendix 9C) listing the “HP Project” as “In House”. An
alternative is to place the samples and/or VOC standards in the fixed base refrigerators that
are monitored daily.
Corrective Action
The corrective action taken in the event of a refrigerator being “off” temperature depends
on the degree of the problem.
If the temperature is lower than expected by no more than 3oC monitoring will take place
to determine if the lower temperature is consistent. A new thermometer will be used to
determine if the thermometer is the cause. If the thermometer is functioning properly, then
after 3 days of low temperature the refrigerator temperature may be adjusted using the
control.
If the temperature is no more than 6oC, monitor and adjust the temp control to achieve a
lower temperature. If the temp is greater than 6oC move the standards/samples to another
refrigerator.
If a catastrophic failure occurs to a refrigerator that contains client samples that have not
been analyzed and reported, the H&P project manager is to be informed that the integrity
of the client’s samples may have been jeopardized. The project manager will then inform
the client of the situation so that a decision can be made whether to resample.
Calibration
The refrigerators that hold client samples must be calibrated routinely to maintain their
temperature at 3oC +/-3o. This will require periodic adjustment of the temperature control
unit.
Bi-Weekly Contamination Check
Every 2 weeks the refrigerators used to store unanalyzed client samples are to be checked
for contamination. This is performed by the analysis of prepared trip blanks that have been
kept in the refrigerator for at least 5 days but less than 14 days. If the trip blanks are
determined to have contamination present above the reporting limit, corrective action is to
be taken.
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Corrective Action
Remove all samples from affected refrigerator and document these project numbers. Find
source of contamination and remove from refrigerator. Decontaminate refrigerator and
repeat trip blank test. Once test confirms that refrigerator is free of contamination, samples
may be returned.
Maintenance
Maintenance includes all activities not addressed in the sections above. The activities
involved may or may not be routine in nature. When they are non-routine consult the
manufacturer’s manual and take the action indicated. Record all maintenance activities in
the Refrigerator's Log along with name and date.
4.2.5 Freezer
The purpose of this section is to identify the procedures associated with scheduled and
unscheduled freezer maintenance.
Daily Operation Check
Once per day the Lab QA Monitor or analyst is to:
1. Read the temperature (Centigrade) on each freezer thermometer.If there is a
correction factor on the thermometer, apply it to the reading.Both the uncorrected
and corrected temperatures are recorded.
2.Record it in the Daily Refrigerator/Freezer QA Log (Appendix 9A1, 9A2 &B).
3. Initial and date the Log.
4.Notify the Laboratory Director immediately if any temperature is out of its
acceptance range.
If the temperature is <-10oC, the unit is functioning properly.
Corrective Action
The corrective action taken in the event of a freezer being “off” temperature depends on
the degree of the problem.
If the temperature is lower than expected by no more than 10oC monitoring will take place
to determine if the lower temperature is consistent. A new thermometer will be used to
determine if the thermometer is the cause. If the thermometer is functioning properly, then
after 3 day of low temperature the freezer temp may be adjusted using the control.
If the temperature is more than -10oC, monitor and adjust the temp control to achieve a
lower temperature. If the temperature is greater than -10oC check the quality of the
standards/samples in the freezer and move to another freezer if necessary.If only standards
are stored in the freezer or freezer compartment, the freezer is not required to be -10oC or
colder. Standards are only required to be kept refrigerated or <3 oC. It is required,
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however, to monitor the freezer temperature of the freezer to ensure that this criterion is
met. These are to be recorded onto the excursion log (Appendix 9C) or the In-house
refrigerator form (Appendix 9A).
If a catastrophic failure occurs to a refrigerator that contains client samples that have not
been analyzed and reported, the H&P project manager is to be informed that the integrity
of the client’s samples may have been jeopardized. The project manager will then inform
the client of the situation so that a decision can be made whether to resample.
Calibration
Once per year check the thermometer against a NIST calibrated thermometer to ensure
accuracy and recorded in the Thermometer Calibration Certification Sheet (Appendix 4B).
The acceptance range will be adjusted accordingly. If the difference exceeds +/- 3 oC
perform maintenance until the problem is corrected.
Unscheduled Maintenance
Unscheduled maintenance includes all activities not addressed in the sections above. The
activities involved may or may not be routine in nature. When they are non-routine consult
the manufacturer’s manual and take the action indicated. Typically, freezers must be
defrosted at least once a year to help maintain proper operation. Record all maintenance
activities in the Freezer Log along with name and date.
4.2.6 Thermometers
The purpose of this section is to identify the procedures associated with scheduled and
unscheduled thermometer maintenance and use.
Operational Check
The following steps are to be followed by the first person using a thermometer on a given
day:
1. Read the temperature on the thermometer.
2. Record it on the Run Log. Both the uncorrected and corrected temperatures are
recorded.
3.Sign and date the Log Run Log once completed.
The analyst or technician is to inform the laboratory director immediately if any
thermometer is broken or not working properly. Digital thermometers may lose some of
their function which will result in an un-clear display. The laboratory director will supply a
new thermometer and will sign and date the certificate that comes with the thermometer
and document which lab or refrigerator it was assigned to.
Calibration
Once per year, check the liquid thermometers against a NIST calibrated thermometer to
ensure accuracy and record the results in the Thermometer Calibration Certification Sheet
(Appendix 4B).This NIST calibrated thermometer is sent annually to an ISO/IEC
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17025:2005 certified company that is capable of certifying it and providing a certificate of
calibration. The annual check correction factor will be entered on the face of the
thermometer. The analyst/technician is to subtract or add this value to the thermometer’s
reading and record it onto the refrigerator, excursion and/or run log.
Digital thermometers must be checked quarterly against a verified liquid thermometer. For
digital thermometers on refrigerators, the chemist is to record the inside (lab temp)
temperature from the digital thermometers and the liquid thermometer quarterly and record
it onto the Digital Thermometer Check Form (Appendix 4F). For digital thermometers on
ovens (summa can cleaning ovens), a liquid certified thermometer is to be placed through
the thermometer hole on the top of the oven. This temperature is to be recorded onto
Appendix 4F along with the digital reading on the can cleaning software for verification.
Unscheduled Maintenance
Unscheduled maintenance includes all activities not addressed in the section above. The
activities involved may or may not be routine in nature. When they are non-routine consult
the manufacturer’s manual and take the action indicated.
4.2.7 Water Dispensers
Water dispensers are used to deliver 20 ml of purged drinking water to VOA vials in the
preparation step for EPA 8260 and H&P 8260SV.
Calibration
These devices are to be calibrated every quarter to ensure that they are delivering the
appropriate volume. Calibration is performed by weighing the delivered volume of water
and adjusting the dispenser to be within 3% of the set volume. This is recorded onto the
Water Dispenser Check Form (Appendix 4G).
Unscheduled Maintenance
Water dispensers are prone to calcium build up and corrective action may need to be
performed if it fails to deliver consistent water volumes or large water bubbles during the
pumping action. If this happens, the laboratory director is to be informed so that the unit
can be repaired and recalibrated.
4.2.8 Digital Vacuum Gauges
Digital vacuum gauges are used to measure the vacuum on summa canisters before they
are sent to clients and when they are returned to H&P for analyses.
Operational Check -Daily
Before use, each vacuum gauge should be zeroed before use. This is accomplished by
attaching the proper quick connect to the end so that it could measure atmospheric
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pressure. Once the reading is stable, verify that the digital readout is at “0.0”. If not, press
and hold the “Zero” key until the readout stabilizes ate this value.
Decontamination Procedures
Before a digital vacuum gauge is used to measure the vacuum in a summa canister it is to
be de-contaminated. This involves removing the “dead-volume’ for the gauge by attaching
it to an evacuated canister (usually called a “COW”). This action is performed before use
and between measuring the vacuum on client’s samples that are in canisters. This “COW”
is to be evacuated weekly to ensure it is suitable for de-contamination procedures.
Calibration
Vacuum gauges are to be certified or verified against a certified vacuum gauge annually.
This program involves sending one of the vacuum gauges to an ISO/IEC 17025:2005
certified company that is capable of certifying it and providing a certificate of calibration.
This can be performed on alternative gauges so that each one is re-certified every other
year. This certified gauge is then used to validate the calibration of the other one(s) and
the data documented on Appendix 4E.
Unscheduled Maintenance
If the digital gauge does not operate properly, refer to the recalibration/troubleshooting
section in the operation manual. The laboratory director is to be informed if the problem
cannot be solved.
4.2.9 Mass Flow Controllers
Mass flow controllers (MFC) are used to measure the flow rate on flow chokes and sample
kits before they are sent to clients. H&P uses two types of MFCs, one to use for flow
between 0 and 25 cc/min and the other for flows between 0 and 500 cc/min.
Calibration
MFCs are to be certified or verified against a certified MFC annually. This program
involves sending one of the MFCs to an ISO/IEC 17025:2017 certified company that is
capable of certifying it and providing a certificate of calibration. This can be performed on
alternative MFCs so that each one is re-certified every other year. This certified MFC is
then used to validate the calibration of the other one(s) and the data documented on
Appendix 4H.
Operational Check -Daily
Before use, each mass flow controller should be checked that it’s display is set to “0.0”
when powered on and not yet attached to the vacuum pump or sample. If the digital
display is not at zero, the controller can be zeroed by using a very small screwdriver to turn
zeroing screw on the side of the unit.
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4.2.10 Summa Canisters
H&P has a variety of summa canisters for sampling ambient air and soil vapor. For
ambient air, a 6-liter summa canister is typically used although a 1-liter may be used if the
reporting limits are higher for a specific client. All summa cans used for ambient air must
have a gauge and valve on them to determine vacuum when sampling. All 6-liter cans also
have a female quick connect attached. Summa canisters that are used for soil vapor range
in size from 200 mL to 1000 cc. The smaller cans, 200, 400, 450 cc in size, do not come
equipped with gauges, only valves and male quick connects. It is recommended that only
cans that are SiloCoated be purchased for H&P sample collection.
4.2.11 TO-15 Summa Canister Cleaning Systems
H&P has 3 summa canister cleaning systems that are used to clean the summa canisters
described in section 4.2.10. Care must be taken when using these systems since they use a
high vacuum pump that can be easily damaged if not used properly. Summa canisters are
not to be attached to the cleaning system unless the high vacuum pump is confirmed to be
off. In addition, the digital thermometers must be verified quarterly, and recalibrated if
necessary, to prevent damage to the gauges due to overheating during the cleaning process.
(See Section 4.2.6)
Scheduled Maintenance and Calibration
The humidifying chamber is to be checked daily to ensure that it is half filled with reagent
water prior to starting the cleaning cycle. Calibration of the thermocouples must be
performed if they fail the quarterly digital thermometer checks. This is done using the
SLNetView folder for Ovens 1 and 2 and through the calibration folder under “settings”
tab for Oven 3.
4.2.12 LIMS and Server
Except for software updates that do not adversely affect our customer’s electronic data,
H&P does not make any changes to the software or hardware configuration of the LIMS
we license from Promium. All requests for customized EDDs are created per client
requirements and do not change the standard EDD templates in our LIMS.
In the event that H&P needs to makes changes to the software or hardware configuration of
our LIMS that adversely affect our customer’s electronic data, we will notify our
customers by email before the changes take effect.
4.3 Field Sampling Supplies
4.3.1 Soil Vapor Probe Construction Materials
All materials used in the construction of soil vapor wells (i.e. Sand, bentonite, tubing,
filters), have been laboratory tested by H&P to show that they are acceptable for use and
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meet the requirements as put forth by H&P. Any new materials or supplies obtained from
sources outside of the approved vendor list (Appendix 7B2) must be laboratory tested prior
to use in the field. These records are kept on file with the Field QA/QC Manager.
4.3.2 Field Sample Collection Supplies
All materials and supplies used in the collection of field samples (i.e. Tubing, Luer
fittings), have been performance tested to show that they are acceptable for use and meet
the requirements as put forth by H&P. Any new materials or supplies obtained from
sources outside of the approved vendor list (Appendix 7B2) must be performance tested
prior to use in the field. These records are kept on file with the Field QA/QC Manager.
Equipment and supply lists with current supplies and lot numbers are kept on each field
vehicle, along with dates added, to track supplies used for field sampling activities. See
Appendix 4I.
5.0 GENERAL LABORATORY PROCEDURES
This section provides descriptions of general laboratory procedures that do not fall readily into the
categories identified by other operating procedures.
5.1 Glassware
This section applies to glassware that is reused and requires cleaning. Much of the glassware used
by the laboratory is pre-cleaned disposal one-time use glassware and does not require cleaning or
washing. Other glassware, such as the glass syringes used for vapor collection, require regular
cleaning. These syringes collect soil vapor samples which will cause the syringes to become
coated with oil and contaminants. The syringes should be inspected daily and cleaned if any film
is observed on the inside walls or if any soil grains are found inside. The oil residue will absorb
target analytes and could affect results. Any soil grains will cause the syringe barrel to jam inside
rendering the syringe useless.
The steps in this procedure that are used with all glass syringes are described below.
1. Wash with Alconox detergent or Simple Green and hot water.
2. Rinse liberally with tap water.
3. Rinse liberally with distilled water three times.
4. Rinse with methanol.
5. Bake syringes until dry
5.2 Waste Management / Pollution Prevention
The purpose of this section is to identify the standard procedures associated with non-
hazardous/hazardous waste removal. It is the policy of H&P to comply with all Federal, State and
Local regulations governing the generation, storage, and removal of waste. H&P’s procedures are
designed to prevent pollution of environmental media through proper handling, storage and
disposal.
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5.2.1 Waste Handling
There are 5 types of wastes that are stored at H&P’s facility. These are solid waste, water
waste, organic solvent waste, oil filter and oil waste. The solid waste includes all soils, and
solids, which are primarily from client samples. Water waste includes all client water
samples and water from prepared VOA vials for the Solatek auto samplers. Organic waste
generally consists of solvent waste that is generated during method procedures or
instrument maintenance. Organic and oil wastes may be recycled through organic/waste
oil recycling programs. Waste oil consists of all oils obtained from maintenance
procedures such as oil changes on generators, pumps and engines. Oil filter waste is to
consist of only used oil filters. See the H&P SOP on Waste and Sample Disposal for more
details.
5.2.2 Waste Removal
Waste drums are removed from H&P’s facility as needed by a licensed waste hauler. No
more than two drums of each type of solid or liquid waste are stored at the facility at any
one time.
6.0 PROJECT MANAGEMENT & FIELD SAMPLING
The purpose of this section is to provide guidelines for acceptable field sampling activities. It addresses
planning, site evaluation, and documentation.
6.1 Project Management
Once a client has contacted H&P for services, it is the responsibility of the H&P project manager
to determine if H&P has the resources, instrumentation and equipment to meet the requirements of
the project. (See SOP on Contracts Requests and Tenders). This applies to all field projects and in-
house analyses. In addition, proper field sampling requires planning to assure that all required
samples are collected, that they are collected in the correct manner, that they are preserved, stored
and shipped in such a way as to maintain their integrity, and that chain-of-custody procedures are
appropriate for the end use of the data. To assure that this is the case, a meeting is held between
H&P’s project manager and the client’s project manager. This meeting is typically conducted via
emails and or phone. The result of this meeting is a Preliminary Sampling/Analysis Plan that
covers:
Client project manager, billing address, contact information
Site evaluation requirements and permitting
Site safety requirements and utility clearances
For vapor samples; vapor probe information, purge volumes and leak check type
Matrix type and total samples to be analyzed and/or collected
Analyte lists and reporting limits,
Sampling points and techniques,
Field analyses and data deliverables,
Sample containers and preservation techniques,
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Storage and shipping procedures, and
Chain-of-Custody procedures.
Once this information is obtained, the H&P project manager will complete a Strataprobe and/or
Mobile Lab Confirmation Sheet (Appendix 6N1 & 6N2). This will be a scheduled as a temporary
job until the client’s project manager confirms the job.
6.1.1 Site Evaluation
Once the Preliminary Sampling Plan has been prepared, a site evaluation is carried out to
verify that the anticipated sampling points, sampling methods and, sample storage and
shipping procedures are appropriate for the location to be sampled. Based on the findings,
a final Sampling Plan is prepared and agreed to by the original parties. This will be
planned before the project begins. Once the project is confirmed and the H&P drillers
and/or chemists are at the site, they will review the sampling plan with the Client’s field
representative to ensure that the sampling can go as planned.
6.1.2 Documentation
Documentation of a sampling expedition consists of the Sampling Plan, a description of
any deviations from the plan, sampling log sheets (FMS 001-012), results of any field
analyses, and Chain-of-Custody records (Appendix 6A&B).
6.1.3 Enhanced Quality Assurance
Additional quality control samples may be used by the laboratory in a field setting as
needed. These include increased frequency of sampling, method and instrument blanks as
well as calibration checks. The frequency of and need for enhanced quality assurance may
be determined by the analyst while in the field or in concert with a supervisor, normally the
laboratory director/QAO. The analysts will report any out of control situations, or non-
conformances to the laboratory director/QAO at the earliest possible moment. The
director/QAO may assign additional quality control parameters if necessary. The analyst is
to record the reasons and corrective actions on corrective action forms (if appropriate) or
directly on extraction and run logs.
6.2 Sample Containers and Sample Preservation
The purpose of this section is to specify proper sample containers and sample preservation
techniques for field sampling activities. For samples that are to be analyzed in the field by the
mobile lab are to be stored in the laboratory refrigerator. Samples that are not analyzed in the field
or require additional analysis not performed by the mobile laboratory will be preserved as stated in
the procedures below. Where local regulatory guidelines are issued (e.g. San Diego County SAM),
these guidelines may supersede this section.
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6.2 1 Volatile Organic Compounds, Gaseous Samples
Samples are collected and stored in glass bulbs with Teflon stopcocks, in Tedlar bags,
summa canisters or syringes. The sampling environment will dictate the type of sampling
container. The combined storage and shipping times for each sampling container are as
follows:
Glass Syringes <15 minutes
Tedlar Bags <72 hours*
Summa Canisters 30 days
Sorbent Tubes 7 days
* Note: Tedlar bags may need to be analyzed within 6 hours for the H&P 8260SV method
to meet regulatory requirements.
Upon receipt at the Carlsbad fixed facility, all summa canisters will have their vacuum
measured. The can # and its vacuum are to be recorded onto the COC next to the
corresponding sample. For soil vapor samples, the vacuum should be from 0 to -10 psi.
For ambient air samples, the vacuum must be at negative pressure but not greater than -10
psi. If any sample is received outside of these criteria, the project manager is to be
informed so the client can be contacted. If analysis proceeds, the data may be flagged, the
RL raised, or a narrative written to describe the sampling issue.
Samples can also be collected in sorbent tubes as per the method specifications (e.g., EPA
Method TO-17) and shipped in glass culture tubes sealed with Teflon lined caps.
Alternatively, sorbent tubes can be shipped in metal sleeves with metal/Teflon sealed caps.
Currently, H&P is not performing the analysis on sorbent tubes but will collect samples in
these containers, as requested subcontracting the analysis out.
6.2.2 Volatile Organic Compounds in Water
Samples are collected into 40-mL glass vials with HCL preservative and Teflon sealed
caps or plastic caps with septa. There is to be no headspace gas in the vial at the time of
sampling (bubble present must be equal to or smaller than ¼ inch in diameter). The vials
used are to be either pre-cleaned one-time use disposable vials or are to be cleaned and
stored in accordance with Section 5.1. Preservation consists of maintenance at ice
temperature at 3oC +/-3o plus any activities specified by the analysis method. Holding time
for water samples are 14 days for preserved samples and 7 days for non-preserved samples.
When water samples are received, the container used is to be inspected to determine if the
samples were placed into preserved contained. If there are no acid stickers or indication
that the containers were the pre-preserved type, it is to be assumed that the samples are not
preserved. This is to be noted on the comments section of the COC so that analysis will be
performed within 7 days of the sampling date.
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6.2.3 Volatile Organic Compounds in Solid and Semi-Solid Media
Samples such as soil, sediment and sludge, are packed into 4 ounce wide-mouthed glass
jars with Teflon lined caps, brass sleeves or Encore® like samplers. Care should be taken
to minimize headspace. The jars and caps used are to be either pre-cleaned one-time use
disposable jars or caps or are to be cleaned and stored in accordance with Section 5.1.
Combined storage and shipping time are not to exceed 48 hours until preparation for
encores or 14 days until preparation for non-EPA 5035 methods. Preservation consists of
maintenance at ice temperature at 3oC +/-3o plus any activities specified by the analysis
method. Although 3oC +/-3o is acceptable, the preferred storage method for soil samples is
to place them in a freezer at <10 oC.
6.2.4 Extractable Organic Compounds in Water
Water samples intended for sample preparation via solvent extraction are collected in
VOAs and can also be collected amber glass bottles with Teflon lined caps. The bottles
and cap liners used are to be either pre-cleaned one-time use disposable bottles and cap
liners or are to be cleaned and stored in accordance with Section 5.1. Preservation consists
of maintenance at refrigerator temperature at 3oC +/-3o plus any activities specified by the
analysis method.
6.2.5 Extractable Organic Compounds in Solid and Semi-Solid Media
Solid and semi-solid samples such as soil, sediment and sludge, or plant or animal tissue,
which are intended for sample preparation via solvent extraction, are collected in 4- or 8-
ounce glass jars with Teflon lined caps. The bottles and cap liners used are to be either pre-
cleaned one-time use disposable bottles and cap liners or are to be cleaned and stored in
accordance with Section 5.1 Combined storage and shipping time is not to exceed 48
hours. Preservation consists of maintenance at refrigerator temperature at 3oC +/-3o
temperature plus any activities specified by the analysis method.
7.0 SAMPLE HANDLING, TRACKING AND SUBCONTRACTING
The purpose of this section is to describe the standard procedures used to assure that samples can be
related to their data and that the data is valid and traceable.
7.1 Sample Handling
Sample control is the process by which samples are tracked in the field and in the laboratory. The
process includes a documented sample tracking system, assignment of a responsible individual to
see that the system is being used properly and occasional audits of the system by management.
The purpose of this section is to describe the procedures used to track samples in field and
laboratory environments. It identifies responsible parties and establishes the mechanism used to
see that samples do not become confused and/or lost.
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7.1.1 Sample Control
This section describes how samples are received and tracked at H&P and who is
responsible for various aspects of these activities.
Samples delivered to mobile laboratories in the field are treated in the same manner as
those received at the fixed laboratory facility with the exception that the analyst begins the
process as the sample custodian. The analyst is responsible for performing checks of
sample integrity and to see that the sample is logged on a chain of custody. If the samples
require additional analyses that must be run at a fixed facility or shipped to another lab the
analyst must see to it that the proper people are notified and that the chain-of-custody has
been marked appropriately.
7.1.1.1 Sample Receipt
Samples are logged in at the time of receipt by the "Sample Custodian" or analyst,
who signs for them, verifies their integrity and fills out any customer specific
forms. All boxes containing summas or tedlar samples that are received at the H&P
Carlsbad facility via UPS, FedEx or other shipping vendor, must be opened, the
samples counted and the CoC signed as received on the day that H&P takes
custody (the date received by H&P). They can be processed/logged in on the
subsequent day or when someone is available.If the Sample Custodian is not
available, his/her designate performs this task. Sample log in includes completing
the Chain-of-Custody(s)(COC) (Appendix 6A&B) and assigning a project number
to the set of COCs that make up the client’s project. For samples received at the
fixed lab facility, this assigned project number is recorded onto the Sample Log In
Sheet (Appendix 7A). The project number consists of Client Code, date of receipt
and a sequential number. For example, samples received from SCS on 2/10/2010
that are the first project received for that date will be assigned a project number
SCS021010-10. The Sample Log In Sheet is to be completed for this project. For
mobile lab jobs, the project number is determined by the project manager and is
listed onto the confirmation sheets. For both in-house and field received samples,
the assigned project number is also recorded onto the COC under “H&P Project#”.
The time of collection of the samples and the delivery to the laboratory are
important pieces of data and should be recorded at time of acceptance of the
samples. If no time is given (only date), the earliest possible time shall be taken as
the time sampled or received. This is also true of sample preparation times and
analysis times later in the procedure.
Each container must receive a unique identifier at this point. Samples with
multiple containers (e.g., water VOAs) can be labeled a, b, c, etc. using indelible
ink.
Samples not meeting the conditions for acceptance may be accepted if the
custodian records the out-of-control conditions on the COC. The laboratory director
or QAO is to be informed of the non-conformance. This is to be recorded in the
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"Comments/Problems" column of the COC and are recorded in the case narrative or
flagged as appropriate. To minimize paperwork and to accomplish the task of
sample receipt H&P uses chains-of-custody forms as sample receipt logs and
analysis request forms. Any list of samples can easily be tracked by day, project
number and finally the chain-of-custody.
If there is any doubt concerning the samples suitability for testing, where the
sample does not conform to the description provided, or where the test required is
not fully specified, the client is to be consulted prior to proceeding. All transmittals
to or from the client are to be kept as permanent records.
If arrangements are made to accept client samples after regular business hours, or
over the weekend, the employee receiving the samples must be able to perform the
following tasks:
Check the condition of the samples (i.e. temperature, intact and proper
containers etc.) and evaluate.
Check that all samples and the number of containers listed on the COC are
present.
Transfer samples to proper storage area (i.e. refrigerator or freezer)
Once regular business hours’ resume, the samples can then be properly logged into
the Element data system and assigned a project number.
7.1.1.2 Sample Acceptance
Samples coming into the lab should be accompanied with a COC that contains
proper documentation including:
Unique sample identification
Location*, date and time of collection (e.g., California global ID)
Collector’s name and signature under sampler information as appropriate
and/or available.Some clients do not know to complete this section. It
would be appropriate for the H&P project managers to assist clients in
proper COC procedures.
Container type – for vapor samples, the size and ID# of the can must be
identified (see below
Preservation type (if applicable)
Other sample requirements are:
Durable labels which have the sample identity written in indelible ink.
Appropriate sample containers:
Water samples for VOC or TPH gasoline analysis should be received in
preserved VOA vials. If they are not preserved, this is to be documented on
the COC. VOA vials should not have any headspace or bubbles that are
greater than ¼ inch in diameter.
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Soil samples are to be received in glass jars, Encore containers (For 5035),
metal sleeves or acetate sleeves. If the samples are in glass jars, they should
not be broken. Samples in broken containers are to be transferred to
another glass jars. This is to be documented on the COC.
Vapor samples are to be received in Tedlars or in summa canisters. Tedlar
bags containing samples are to be placed in a box or dark plastic bag to
keep them away from sunlight. Summa canisters are to be checked by a
vacuum gauge upon receipt and their vacuum is to be documented on the
COC along with the gauge ID# used to measure vacuum. The measured
vacuum is to be compared to the gauge reading on the can (1-liter and 6-
liter cans with gauges). This can only be done on 1 liter and 6 liter cans as
they are the only ones with a gauge. If there is a discrepancy between the
two readings, the Technical Services/Health & Safety Manager is to be
informed as the summa gauge may need replacement. The can number is
also to be recorded onto the COC for each sample. Any sample that has a
vacuum greater than -10 psi may not have enough sample in the summa
canister to perform analysis. The project manager is to be made aware of
this issue.
Adherence to holding times
Adequate sample volume to perform tests.
Proper temperature ** (not applicable to samples received and analyzed in
the field). The inside temperature of the sample cooler containing the
samples is to be measured using the IR thermometer. The cooler is to be
checked to see if a temperature blank has been included. If one is available,
the IR gun is to be used to record the temperature of these blanks.Vapor
samples received in tedlars or summas are received at room temperature and
indicating this as “RT” is acceptable.Document on chain-of-custody.
The sample receiver should check that all containers meet the above criteria.
* Optional item/information
** If the samples are less than 4 hours old, they may be accepted even if they
exceed the temperature limits if there is evidence of the chilling process
having begun (e.g., arrival on ice)
7.1.1.3 Sample Storage Locations
Unprepared soil and water samples received in the field are stored in the mobile lab
refrigerators or in an ice chest. If an ice chest is used, the temperature is to be
checked routinely to ensure the proper temperature is maintained. The samples are
then transferred to a refrigerator for water samples or a freezer for soil samples at
the fixed facility at the end of the day or upon return to the fixed facility. Samples
received at the fixed laboratory are stored in a refrigerator or freezer as appropriate,
at the fixed facility. Any soil or water sample that is suspected or designated as a
“hot” or highly contaminated sample is to be stored in a separate refrigerator or
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freezer than other samples for mobile laboratories, the analyst is to double bag
contaminated samples and place them in a cooler, separate from other samples.
Vapor or ambient air samples are stored at room temperature.
7.1.1.4 Reviews, Tenders & Contracts (See SOP)
Samples may be received at H&P that are from a contract or from a project that has
been organized and scheduled by the H&P project managers. Therefore, it is
critical that all COCs received are reviewed by the project manager to ensure that
the COC reflects what was set up in the project or contract. All contracts are
reviewed and accepted only if H&P has the resources and capabilities to perform
the work. The projects managers will review the COC received and perform the
following:
Verify that the sample analyses, analyte list, units and RLs match the
contract/project
Contact the client to discuss any deviation from contract/project
Communicate to Lab Director or to receipt personnel what the client wants.
Ensure that the client’s information, including email is clearly written and
correct
Once the project and work order (COC) is entered into Element, the laboratory
director or authorized person, is to verify that the analyses to be reported will meet
the client’s expectations.
7.1.1.5 Sample Analysis
Sample analysis, or sample screening, shall not proceed unless the analyst has a
copy of the COC to review.
Water Samples:The analyst will check the preservation of water samples using pH
paper prior to analysis and note the pH and any discrepancies on the analytical run
log.For VOC analysis, an aliquot of the water sample is measured using a
volumetric glass syringe. If an aliquot between 1 – 20 mL is to be analyzed, the
sample is to be poured directly from the VOA into the appropriate size glass
syringe to the top to minimize headspace. The barrel is then inserted into the
syringe and the volume adjusted accordingly. For smaller aliquots than 1 mL, the
syringe must be placed into the VOA containing the sample and the sample slowly
pulled into the syringe to the desired volume. If reanalysis is necessary, an
unopened VOA containing the sample is to be used to obtain a new sample aliquot.
Soil Samples: Soil samples are typically non-homogenous in nature. The analyst
is to make an attempt to reduce this by obtaining an aliquot of sample that is more
representative of the entire sample. Any twigs, rocks, or asphalt is to be removed
from the sample aliquot obtained. The sample should be mixed but not to an extent
that volatiles are lost. For EPA 5035 this is not possible as the soil samples are
collected in Encore samplers.
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Multiphase samples: In the case that a client submits a multiphase sample for
analysis they should be informed that this sample will be treated as more than one
sample and charged accordingly. The client may choose one phase only to be
analyzed and this must be documented in writing and described in the narrative of
the report. If both phases are analyzed they are to be separated into separate
containers, labeled and analyzed per the standard operating procedures for the
specific matrix.
Vapor samples: These are received in tedlars bags or summa canisters. If they are
received in tedlars bags, the CoC is to be reviewed promptly as the holding time is
only 72 hours or less. Vapor samples received in summa canisters have a holding
time of 30 days, so it may be necessary to transfer the samples that arrived in
tedlars into summa canisters if analysis cannot be completed within the holding
time.
When samples or sample extracts are being analyzed, instrument RUN LOGS are
to be filled in by the instrument operator as per the SOP associated with the
instrument used.
7.1.1.6 Sample Disposal
All hazardous samples are to be returned to the client if possible. Non-hazardous
samples are returned to the fixed facility and placed in appropriate disposal
containers. The disposal containers are removed by a certified waste hauler
according to all local, State and Federal regulations. Non-hazardous samples may
be disposed of as deemed appropriate by the Sample Custodian.
7.2 Sample Tracking and Traceability of Measurement
All samples received by H&P and all fractions generated from those samples are logged into our
Laboratory Information System (LIMS) for tracking and reporting. H&P uses the LIMS system
known as “ELEMENT” from Promium Inc. of Bothell, WA. The LIMS system maintains all the
reportable data that is sent to the clients, including all QA/QC data.
The ELEMENT system is a comprehensive LIMS system whose complexity is beyond the scope
of this document. The user is referred to the ELEMENT user manual available on the individual
computers and also H&P’s separate SOP describing use of the ELEMENT LIMS.
7.2.1 Project Names and Work Orders
Each project will be assigned a unique ID number, called project #, upon receipt (See
section 7.1.1.1.). This project number is entered in the LIMS. This is where custom
analyses can be created which will allow the data to be reported with special analyte lists
or units. After the project is created in element, a work order is created which represents a
COC. Each day of the project will be assigned a unique ID# by the LIMS called a work
order #. The work order number is a sequential number as follow:
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The general format is LYMMNNN where “E” = H&P lab designation name, “Y” =
year sample received, “MM” is month and “NNN” is a consecutive number
between “000” and “999”. For example, E211010 was the 10th work order received
in the Escondido (Now Carlsbad) lab in the month of November 2012.
Every sample that is recorded on a COC should be entered into the ELEMENT data
system. regardless if they are to be analyzed or not. They should be entered in the
same order as they are on the COC. If both waters and/or soils are received the
same day as vapors, they must be written on different COCs. Vapor samples are to
be recorded onto Appendix 6A1 and water/soil samples are to be recorded onto
Appendix 6A2. In this situation, different work order should to be created for each
COC under the same project.
7.2.2 Filename Assignment
Raw data filenames for GC and GC/MS are assigned by the analyst acquiring data for a
fraction at the time the data are acquired. These assignments are at the discretion of the
analyst. It is usually desirable, though not necessary, to use a portion of the sample code in
the data filename. At a minimum, the sample name must be saved in the data file and
recorded on the sample run logs. e.g., A sample labeled MW-1 might have a filename EO
MW1.D where EO is the client abbreviation. The data file name procedures for standards
analyzed during calibration are the concentration followed by the date of calibration. For
example, “5 ng 5-11-19” or “10 ppbv 3-2-19”.
Traceability of measurement is maintained by keeping all the sampling data, project notes,
raw analytical data and final report and review notes in a single file. The information
included will provide a thorough documentation of the following:
A documentation of project set up notes, as needed, and/or confirmation sheets
A documentation of all devices used in the sampling and analyses of the samples
Procedures used in the sampling and analysis
Names of personnel performing all work
Reagents and standards used in the analysis of all samples Sampling and Chemist’s
log sheets and run logs
All chromatograms and manual integrations
Data Review Documentation
7.3 Subcontracting of Sample Analysis and Field Sampling Work
7.3.1 Sample Analysis
H&P will not, under its DoD, NELAP and ELAP accreditation, subcontract work out
without prior notification to the client. Analyses for which H&P is accredited under ELAP
will be performed by H&P unless ELAP certification is not available for the specific
method or if H&P does not have the capability to analyze the samples. Analysis for which
H&P is not accredited, will be subcontracted with the client’s permission to a laboratory
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with an acceptable accreditation. Approved subcontractors and vendors for laboratory
analysis are listed in Appendix 7B1.
Samples, which are to be subcontracted for NELAP or DoD work will only go to NELAP
or DoD, accredited laboratories. DoD samples must receive approval in writing from the
client prior to subcontracting to an outside laboratory. In addition, the reporting of
subcontracted results will be sent directly to the client.
7.3.2 Field Sampling
H&P will not, under any circumstances, subcontract any of the FSMO (Field Sampling and
Measurement Organization) services for the purpose of collecting environment field
samples.
8.0 QUALITY CONTROL, DATA REVIEW, & PERFORMANCE TESTING
The purpose of this section is to define guidelines for the quality control (QC) procedures and systems
used by H&P. H&P is committed to providing the highest quality data possible to their clients. The
following listed items are used to achieve H&P’s quality objectives:
8.1 Sample Quality Control
These include blanks, method checks, matrix spikes, replicates, the use of matrix spikes and
surrogate spikes and calibration check procedures. Corrective actions are addressed as appropriate.
All Quality Control samples are to be processed in the same manner as the field or unknown
samples.
8.1.1 Blanks
Blanks are analyzed to demonstrate that analytical results are representative of samples and
not of contaminants inadvertently entering the samples. Because contamination can take
place via a variety of mechanisms there are several types of blanks that may be analyzed to
monitor the process. These include Client’s Field Blanks, H&P’s Field Blanks, Trip
Blanks, Reagent Blanks, Method Blanks and Ambient Air Blanks. Each of these is
discussed below.
8.1.1.1 Client Field Blanks
Client field blanks are generated by the client’s field sampling team and shipped to
H&P where they are analyzed. All client field blanks received are to be analyzed if
they are requested to be analyzed on the COC.If these blanks show contamination,
laboratory blanks must be analyzed to determine whether it is due to field or
laboratory activities. If contamination is detected in the Client Field Blank but not
detected in the Lab Blank, this indicates that potential contamination of the samples
has resulted from some aspect of the field sampling activity. For the purpose of this
evaluation a contamination is defined as the presence of any analyte at or above its
reporting limit.
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8.1.1.2 H&P Field Blanks
H&P’s field blanks are generated by the sampling equipment and equipment used
to collect field samples. All H&P’s field blanks received are to be analyzed unless
otherwise requested by the client. For soil vapor jobs, the client may specifically
request or submit field blank samples. If these blanks show contamination,
laboratory blanks must be analyzed to determine whether it is due to field or
laboratory activities. If contamination is detected in the H&P’s Field Blank but not
detected in the Lab Blank, the H&P PM should discuss the potential contamination
with the client. Further, as corrective action, an attempt should be made to
determine what caused the contamination and the source should be eliminated. For
the purpose of this evaluation a contamination is defined as the presence of any
analyte at or above its reporting limit.
8.1.1.3 Trip Blanks
Trip blanks are prepared at the laboratory and provided to the client for use. The
client will use trip blanks to track any contamination that has occurred during
shipment or travel to the laboratory for analysis. Typically, water samples are
transported to a laboratory in a cooler and a trip blank is placed in the cooler along
with the client samples. Upon analysis, any hits in the trip blank may be assumed
to be a result of being placed in the cooler and one of the client samples was
heavily contaminated enough to cause cross-contamination. H&P does not
recommend the use of a trip blank for air/soil vapor samples, but some regulators
insist on using them.
8.1.1.4 Reagent Blanks
Reagent blanks are generated in the laboratory and analyzed to identify possible
sample contamination by the reagents used in preparing the samples. For the
purpose of this evaluation a contamination is defined as the presence of any analyte
at or above its reporting limit. If a contamination is identified, corrective active
consists of identifying its source and eliminating it; sample analyses are not to be
carried out during this period of corrective action.
Reagent blanks are to be analyzed whenever a new lot of reagent is incorporated
into the analytical procedure. This analysis is to be performed and the data are to be
evaluated prior to using the reagent(s) on field samples. Results are to be recorded
and filed with the reagent certifications.
8.1.1.5 Method Blanks
Method blanks are analyzed to demonstrate that the interaction of reagents and
sample preparation and analysis procedures do not lead to the generation or
incorporation of contaminants. For the purpose of this evaluation contamination is
defined as the presence of any analyte at or above its reporting limit. If
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contamination is identified, corrective action consists of locating and eliminating its
source; sample analyses are not to be carried out during this period of corrective
action. If the chemist is unable to eliminate the contamination problem, the client is
to be informed that the data will be flagged for the specific target analytes that are
reportable in the method blank.
Method blanks are to be analyzed for each analytical batch of 20 samples or less.
The method blank is to contain all the reagents and materials that are used in the
preparation of samples.
For DoD samples, the method blank will be considered contaminated if:
The concentration of any analyte in the blank exceeds ½ of the reporting
limit or is greater than 1/10 the amount in the samples;
The concentration of any common laboratory contaminant exceeds the
reporting limits or
The blank result otherwise affects the sample results as per the test method
or project specific objectives.
If the method blank is contaminated as described above, then the laboratory shall
reprocess affected samples, except when the contamination is below the LOD. If
insufficient sample volume remains for reprocessing, the results shall be reported
with appropriate data qualifiers.
8.1.1.6 Ambient Air Blanks
Ambient air blanks apply to soil vapor jobs whereby an aliquot of the outside air at
the site is collected and analyzed. For H&P’s 8260 SV method, this ambient air
blank is reported as the method blank for fieldwork. The blank requirements listed
above shall apply to ambient air blanks for H&P 8260SV analyses.For EPA
and/or H&P TO-15 jobs it will be analyzed per client request and will be a sample
added to the COC.
8.1.2 Instrument Calibration
Prior to analyzing any samples instruments must be calibrated to ensure that a valid dose
versus response curve is attained. All analytes are quantitated against calibration curves
and not against daily one-point calibration. The requirements for calibration are usually
prescribed in the published methods, however individual clients, regulators and agencies
may have made changes to the procedures in the method as originally written. These
changes should be known, discussed and plans made to include them prior to the actual
work. If no specified calibration changes are made for a project, the analyst is required to
follow the most current H&P SOP for the specific method they are performing.
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8.1.2.1 Initial Calibration Curve and Verification
Once the number of standard points and their introduction technique is decided, the
analyst analyzes the standards and prepares a response curve. For GC or GC/MS
analysis this usually takes the form of a plot of response (e.g., area of a GC peak)
as a function of amount (or concentration). The curve must meet various
acceptance criteria in order to be deemed “valid”, depending on the project or data
quality objectives that are being followed. For instance, the linearity of the curve
must be assessed. The analyst (or computer) calculates the validity of the curve.
There may be more than one or more acceptance tests performed on the Calibration
curve.
For GC/MS analyses the number of points in an Initial Calibration Curve is no
fewer than five points. For many GC analyses the number of points in an Initial
Calibration Curve is no fewer than three points. TPH analysis by GC requires at
least 5 points in an ICAL. A greater number of points may be used in the event that
certain multipoint calibrations are used e.g., quadratic curve fitting which requires a
minimum of 6 points. All targets and surrogates are included in the calibration
curve. To achieve linearity, an analyst may choose to remove the lowest or highest
calibration level, but may not remove the middle calibration levels.
It is also common for the lowest point on the curve to be assigned as the
laboratory’s LOQ or reporting limit since it is easy to calculate precision and bias
from one of the points on the curve. Likewise, the highest standard is usually
defined as the high point of the curve. No data may be reported less than the LOQ
or greater than the high standard without also noting that the data may have
lowered certainty through the use of defined flags or in the report narrative.
For most (not SIM or TPH) GC/MS methods, once the Initial Calibration is created,
it is verified with a mid-point standard from a second source, procured separately
from the original solution, which was used to prepare the primary standard used in
the calibration curve. The second source is called an Initial Calibration Verification
(ICV) and is analyzed and quantified against the original (or primary) standard.
This test ensures that a “bad” or degraded standard was not used for the original
calibration. The ICV must meet criteria specified in the method or SOP in order to
continue on to sample analysis. If no second source is available from a second
supplier, a second lot number from a single manufacturer may suffice as a second
source.
Most methods further ensure accuracy of the calibration curve by specifying the
length of time (or number of samples) that can be analyzed on one initial
calibration curve. All records from the initial calibration should be retained by the
analyst and added to the project folder or computer record. All calibration curve
packages are to be delivered to the QAQC officer for approval.
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8.1.2.2 Continuing Calibration
Calibration checks are carried out daily to verify that a previously established
response relationship remains intact. It involves analyzing a calibration standard
(usually corresponding to the middle point of the curve) for each target analyte
reported and comparing the responses encountered with those of the previous
calibration based on percent difference. This midpoint standard is called a
Continuing Calibration Verification (CCV). When the average response
deviations for an analyte become greater than method criteria, the system must be
recalibrated. Compliance depends on the system and application involved and is
defined in specific QAPs or hardware specific SOPs.
Corrective action for CCV %Rs which do not satisfy the acceptance criteria
consists of the following:
Contact QAO/Lab Director to receive approval to proceed with CCV as is, or;
Re-analyze two additional consecutive CCVs. If the second analysis of a CCV
passes and the method is a DoD approved method, the analyst should reanalyze
another CCV to verify instrument performance before proceeding with method
blank and sample analysis. If these fail, a senior chemist or the Lab Director
should evaluate the method. If the CCV shows signs of degradation, the working
stock may be compromised. In this situation, the 2nd source standard is to be
analyzed to verify this. If the 2nd source results in acceptable recoveries, the QAO
and/or Lab Director should be contacted to get approval to proceed with analysis. If
the CCV is still unacceptable the Lab Director may decide to pull the instrument
off line for recalibration. The Lab Director /QAO may decide to give approval to
proceed depending on the analytes affected and if the recoveries are biased high or
low. It may also be necessary to inform the client of the discrepancy as the client
may not be concerned with that specific analyte. Regardless, if analyses proceed,
the data will be flagged accordingly.
8.1.2.3 Quantitation of samples
Samples are quantitated using the initial calibration curve rather than a continuing
calibration. When samples fall outside the high range of the calibration curve, they
are diluted in order that the samples fall within the range of the curve. If they fall
below the lowest point standard (RL or LOQ), they are reported as “non-detect” or
can be “J” flagged to the MDL or LOD.
8.1. 3 Method Checks
Method checks are to be carried out whenever a new analytical procedure is incorporated
into the laboratory or whenever a previously used method is reactivated. Method checks
are also required for each batch of soil, water, and vapor samples by spiking sample media
with the analytes of interest and determining their recoveries. These recoveries are
acceptable when they fall within control limits set based on values anticipated from
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literature data or previous laboratory experience or control charts. The specific acceptable
recovery values must be incorporated into the project QAP. Method check recoveries
(%MCR) are calculated as:
SA - SR
%MCR = ---------- x 100 (eq 1)
SA
where SA is Spike added and SR is Sample Result
Alternative method checks can be performed by analyzing single and/or double-blind
performance testing samples, reference materials or by intra-laboratory studies and
evaluating if they pass the control limits. In addition, the %MCR recoveries for each
analyte can provide information as to whether the method is resulting in bias high or bias
low results.
8.1.3.1 Laboratory Control Samples (LCS)
Lab Control Samples are checks carried out for each matrix (e.g., soil, water,
vapor) to determine the expected recoveries that will occur under the most ideal
conditions of the method. Matrix samples, which are free of target analytes and
matrix interferences, are spiked with the targets (from a different source than
calibration standards) and surrogates (if part of the method) followed by
determination of spiked analyte recoveries. These recoveries are acceptable when
they fall within set control limits based on values anticipated from literature data or
previous laboratory experience. The specific acceptable recovery values must be
incorporated into the project QAP. Spike recoveries (%R) are calculated as:
SR
%R = ------------- x 100 (eq 1)
SA
where SR is the result and SA is the amount of spike added.
LCS spike analyses are to be carried out once for every batch of samples or type of
matrix or 20 samples. For soil and water samples, the LCS is performed in
duplicate.
Corrective Actions
Corrective action for LCS %Rs which do not satisfy the acceptance criteria consists
of the following:
Re-analyze another LCS. If the second analysis of LCS fails, a senior chemist or
Lab Director should evaluate the method. If there are less than 11 analytes spiked
and/or reported in the LCS, re-analyze all samples performed under the particular
LCS as this shows that the method is not functioning at this time.
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Marginal Exceedances are not currently used to evaluate LCS data. However, it
may be used in the future to determine whether a batch of samples requires
reanalysis. Marginal exceedances will allow a batch of samples to be accepted if
greater than 11 analytes are spiked and reported in LCSs as follows:
11-30 analytes in LCS, 1 analyte allowed in ME of the LCS control limit
31-50 analytes in LCS, 2 analytes allowed in ME of the LCS control limit
51-70 analytes in LCS, 3 analytes allowed in ME of the LCS control limit
71-90 analytes in LCS, 4 analytes allowed in ME of the LCS control limit
> 90 analytes in LCS, 5 analytes allowed in ME of the LCS control limit
The control limits for the LCS and LCSD are evaluated for each method and matrix
by using 3 standard deviations around the mean recovery using control charts. All
DoD certified methods are to use the DoD LCS/LCSD criteria if available, however
control charts are evaluated quarterly and at the end of the year to determine if
H&P meets these criteria and if corrective action must be taken to improve the
methods performance.The limits of the marginal exceedances are determined for
each method by using 4 standard deviations around the mean recovery for each
analyte determined using control charts. The QAO is to monitor any failed LCS
recoveries on an instrument basis to determine if the LCS failures are not random.
A non-random event is one whereby an analyte fails 2 out of the last three LCS
sets. Any non-random issues are to be brought to the attention of the Lab Director
who may reschedule the instrument for recalibration or other corrective actions.
Any analyte failing the LCS criteria is to be flagged and the data qualified as biased
high or biased low.
8.1.3.2 Matrix Spikes
Matrix spikes are checks carried out for soil and water samples by spiking target
analytes into field samples followed by determination of spiked analyte recoveries.
These recoveries are acceptable when they fall within set control limits based on
values anticipated from literature data or previous laboratory experience. The
specific acceptable recovery values must be incorporated into the project QAP.
Matrix spike recoveries (%R) are calculated as:
SSR - SR
%R = ------------- x 100 (eq 2)
SA
where SSR is the spiked sample result, SR is the sample result and SA is the
amount of spike added.
Matrix spike analyses are to be carried out once for every batch of samples or type
of matrix or 20 samples. Matrix spikes are always performed in duplicate.
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Corrective Actions
Corrective action for matrix spike %Rs which do not satisfy the acceptance criteria
consists of the following:
Reanalyze the sample to demonstrate that the problem is not related to instrument
operation. If the %R is within limits after this second analysis, prepare a matrix
spike duplicate and continue with other samples.
If the %R is still outside the limits, the effect is considered a matrix effect and a set
of blank spikes (LCS &LCSD) are to be prepared and analyzed to indicate the
unacceptable matrix spike recoveries are due to a matrix effect and not an
instrumental problem. Matrix spike results are reported with a flag to indicate
questionable quantitative results due to matrix effects.
8.1.3.3 Replicate Analyses
Replicate samples are analyzed to determine and monitor analytical or sampling
precision. In order to generate a useful database of these data they should be
performed using replicate matrix spiked samples (see Section 8.1.3.1 or 8.1.3.2).
Precision may be evaluated in terms of % difference using duplicate samples or
relative standard deviation when larger numbers or replicates are involved. Percent
differences (RPD) are calculated as:
(C1 - C2)
RPD = -------------- x 100 (eq 3)
(C1 - C2)/2
Replicate analyses on samples are performed routinely on vapor samples for most
field jobs at a frequency of one per day per mobile lab. Water and soil replicates
are only performed if requested by a client for a project. If requested,replicate
analyses for soils and waters are to be carried out once for every batch of samples
or type of matrix or 20 samples.
Corrective Actions
Corrective action options for RPD are which do not satisfy the acceptance criteria
consists of the following:
Reanalyze the sample to demonstrate that the problem is not related to instrument
operation. If the RPD is within limits after this second analysis, continue with other
samples. If the RPD is still outside the criteria, report the two results that are the
closest to each other and results can be reported with a flag to indicate questionable
quantitative results due to matrix effects or non-homogeneity of sample.
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8.1.3.4 Surrogate Analyte Analyses
Surrogate analytes are added to samples to monitor recovery and precision on a per
sample basis. H&P regularly only adds surrogates to GC/MS analyses Surrogates
are selected so as to mimic target analyte behavior during workup and
measurement. Surrogates are monitored in terms of the % recovery (%R in eq 1). A
range of acceptable %Rs (acceptance criteria) is established based on literature or
laboratory data and the experimental results compared to these. Control limits are
also evaluated using control charts each quarter and at the end of each year to
determine if the surrogate criteria are to be changed or if corrective action is
necessary to improve method performance.
Corrective Actions
When the surrogate %Rs for a sample are outside the acceptance criteria range, the
following corrective actions are taken:
For soil and water samples, the sample is reanalyzed to establish that the
unacceptable value(s) is not a result of equipment failure. If a single reanalysis
solves the problem, the analyses may be continued. If the reanalysis confirms that
there is matrix interference, the surrogate may be flagged accordingly. Additional
samples from that project need not be reanalyzed if the same surrogate recovery
fails. For vapor analysis by H&P 8260SV, only 3 of the 4 surrogates need to be
reported. For the TO-15 method, 2 of the 3 surrogates need to be reported.That
failing surrogate should be removed from the report or flagged appropriately. Only
one surrogate can be removed per client project. Usually, a failed surrogate
indicates that target analytes may be affected as well. The analyst should consider
what effects these may be. Since the same surrogates are spiked into blank spikes,
CCVs and method blanks, the analyst should review that surrogate recovery in
these samples to help determine if it is true matrix interference.
If %Rs are outside of the range for acceptable data, and there is a significant matrix
effect,typically internal standards, if used, will fail. When internal standards fail
their recovery criteria, the sample should be reanalyzed at a higher dilution factor.
(see section 8.1.3.5)This must be noted on the sample data report.
8.1.3.5 Internal Standards
When internal standards are included as part of the analytical protocol, they are
spiked into the prepared sample just prior to analysis and their response and
retention time is used as an indication that instrumentation is functioning
acceptably. Acceptable internal standard data is defined as that which falls within
acceptance criteria windows that have been established for the associated method.
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Corrective Actions
When internal standard responses or retention times are outside the acceptable
ranges, corrective action must be taken. This consists of the following steps:
The sample is reanalyzed to demonstrate that the unacceptable result is
reproducible. If the problem is corrected on reanalysis, no further action is required.
This is performed only if the sample is not contaminated.
If the unacceptable data are reproducible, the daily calibration check is reanalyzed
if instrument malfunction is suspected. If the calibration check is acceptable, the
problem is related to a matrix effect and the sample is to be reanalyzed diluted or
the data report must be flagged to this effect. In either case this must be recorded in
the analysts run log.
If the internal standard is out due to the high concentration of contaminants in the
sample, dilute the sample accordingly and reanalyze or qualify appropriately.
If the daily check results are unacceptable, the instrument malfunction must be
corrected (see the operator’s manual), the problem and its solution recorded in the
instrument log. Finally, the instrument must be recalibrated as per the method
requirements.
8.2 Data Review
The purpose of this section is to describe the responsibilities and the process for data review.
8.2.1 Data Review Responsibility
It is the dual responsibility of the Laboratory Director and the QAO to see that data is
reviewed and that any problems identified are solved through the application of appropriate
corrective actions. The data reviewer and original analyst have secondary responsibility to
assist in the data review process.
All data must receive a three-tiered approach in the review process. The analyst is
logically the first level in the data review process. The analyst reviews 100% of his/her
work on any project. The analyst reviews the data for completeness and to ensure that it
meets the data quality objectives for the project as to method suitability, quality control
checks, including calibrations and samples quality control. The analyst completes a Tier 1
Review Checklist (Appendix 8 B). The chemist may be instructed by the QAO or Lab
Director to flag the data using the list of approved data qualifiers (Appendix 8A).
The second level is the QA/QC level. The Quality Assurance Officer or designated
reviewer also reviews 100% of the data produced by the analyst. In addition to all that the
analyst reviews the supervisor reviews the data for its impact and suitability for the
particular project. The reviewer is to ensure that:
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Results meet lab specified QA/QC or project specified QA/QC, if appropriate.
Data meets project specified objectives
Samples were prepared and analyzed appropriately
There is a complete explanation of any anomalies to put in the case narrative.
It may be necessary to add data qualifiers in order to flag out-of-control data. Appendix
8A has a list of approved data qualifiers.
Finally, the data is reviewed for project completeness and appropriateness by lab
administration, who signs off on the final product. The Quality Assurance Officer and
administrator complete a Tier 2 & 3 Review Checklist (Appendix 8 C).
8.2.2 Data Review Process
H&P’s Report Review:
1. Folder
Project Number
Project Name (site)
Project date
2. Accounting Information
Lab confirmation form
Chemist Daily Project Summary
Report to information
Billing to information
3. Print report on plain paper or review electronically
4. From Chain of Custody Record confirm:
a. Chain of custody sample names match report
b. Any special instructions
c. Vapor Collection - Yes No Incomplete
Page 1: Client name & address
Project name & number
Client contact
Report to be copied to anyone
(Do not cc: without permission, note who gave permission in
the report file)
Date, number, & matrix of samples
Enter H&P Mobile Geochemistry, Inc project number
Page 2: Check off each sample number listed on the CoC
Check sampled and received date
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5. From Raw Data:
Organize raw data in order of date
Go through the raw data page by page
Tier 1: Completed and accurate?
Run Log (analytical)- Is it complete?
Chemists’ notes – Any problem(s) listed for flagging data or writing a
narrative?
Date - is the correct date analyzed listed?
Blank - is it clean?
CCAL - is it acceptable?
Sample - identify each individual chromatogram does it belong in this
report, if not where does it go
Put a check mark next to all confirmed results above the RL (MDL/LOD if
J flags requested
QC - MS and/or LCS
Internal Standard Recoveries acceptable?
Internal Standard Summary Sheets – Are they included? For level 3 and 4 data
deliverables only
6. From the Chain of custody
Re-read the CoC.
Are there any special instructions?
Have all analyses requested been performed?
Any instructions in the 'Comments' section?
7. Edits
Make all changes
Flag data if necessary and/or write narrative (see section 8.3)
Generate a final PDF and print out on letterhead, if requested.
Compare final to rough draft
8. EMail PDF
Prepare the report, CoC, chromatograms, sampling log (if needed)
Prepare data deliverables if requested
Make a complete copy for our file on server (electronic only)
8.2.3 Re-issuance of Reports
If a report is to be reissued or revised, it must be uniquely identified as being a separate
report from the original or other reissued reports (i.e. SCS10011-10 Rev__). The
ELEMENT LIMS system will identify each report by date and time. This, along with the
element project number or work order is a unique identification for the report. The data
reviewer must also make certain that the latest report contains a reference to the previous
reports. This will be handled by addition of a narrative or to refer to this change in an email
to the client. The reason for the revision must be provided in the narrative.
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8.2.4 Data File Security
The data reviewer(s) will maintain a password protected computer folder. Access to the
folder will only be supplied to technical personnel/data review personnel and
management/QA personnel.
8.3 Performance Testing
As part of the ongoing process of maintaining Quality environmental test data, H&P participates
in nationally accredited performance testing of its analytical procedures. Depending upon the type
of accreditation, this is normally once per calendar year. For DoD and some out-of-state
certifications, a PT sample must be analyzed twice per year for each matrix. If PT samples are not
available, intralaboratory studies are to be performed. H&P uses ISO 17034 certified and ISO
9001 certified providers of PT samples whenever possible. PT samples should be processed under
the identical conditions which ordinary samples are analyzed.CA ELAP has specific
requirements in the case of a “not acceptable” score for PTs.See SOP for Performance
Testing for CA ELAP requirements and a discussion of PT procedures.
Under the NELAC and DoD program, a score of more than 80% is a passing score for a given PT
study. Also, any single analyte may not fail consecutive studies in order to be considered a
passing score. Any failures for any analyte must be researched for the root cause of the failure.
Corrective action is then taken to ensure the failure is not repeated. This corrective action must be
documented onto a preventative/corrective action form (Appendix 11G). For DOD certifications,
the auditor for the DOD must be informed if the same analyte fails two consecutive times for a
specific analytical method. The PT results are entered onto the Compliance checker provided by
PJLA to assist in tracking analyte performance.
If PT samples are not available for a specific method, intralaboratory studies are to be performed
on the same schedule as PT samples. Intralaboratory studies are performed using a series of 4
replicates of the same spiked sample. The average for each analyte for each laboratory is to be
calculated as xl.Then the true value for each analyte is to be defined as Xl. The percent error for
each laboratory can then be calculated as:
% Error = 100(Xl - xl)
Xl
The % Error for each analyte must meet the method requirements. If not, the result is considered a
failure. Each analyst must achieve acceptable results for 80% of the analytes reported. The
overall average for all labs for each analyte is to be calculated. The % Error for the total average
is to be determined. The total laboratory average must also pass 80% of the analyte for the
method to be considered a valid method. More detailed information regarding how PT studies and
Intra-laboratory studies are evaluated are outlined in the Performance Studies SOP.
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9.0 DATA HANDLING
The purpose of this section is to define the standard data handling procedures used by H&P.
9.1 General Laboratory Data
Technical employees are to use laboratory logs for the purpose of recording data and observations
related to general laboratory procedures. H&P retains a master list of all log books used in the
laboratory.These logs will be supplied by H&P and remain the property of H&P at all times.
Logs are to be maintained legally in blue ink and are to contain all data and any notes describing
any general laboratory related observations. The following are logs relating to general laboratory
data:
9.1.1 Standard preparation logs –
These logbooks are bound notebooks that have pre-numbered pages and are maintained at
the main Carlsbad facility. The preparation for all standards used for calibration purposes
are documented in these notebooks. There is a separate standard preparation logbook for
vapor standards and for liquid standards. The format for liquid standards is “LP” for stock
standards, “LS” for secondary stock standards and “LSS” for working stock standards. The
format for vapor standards is “AIS” for internal standard/surrogate standards and “ACC”
for first and second source working standards. The information for any prepared standard
must include:
-Date prepared
-Initials of chemist preparing standard
-Lot number, name, amount, concentration, and expiration of stock standard
used
-Final volume of standard
-Solvent or diluent gas used and its lot number and expiration date (if provided)
-Lot number, name, concentration, and expiration date of standard prepared.
-For vapor standards, the summa canister used for its preparation.
After the standard preparation is recorded in the standard preparation logbook, if there is
not enough room at the bottom of the page for an additional entry, the analyst must close
out the page using a large “Z” at the bottom with their initials and the date that the page
was closed out.
9.1.2 Refrigerator/Freezer logs –
These logbooks do not have to be bound but must be maintained for all refrigerators and
freezers that are used to store samples or standards. This includes all the refrigerators in
the bay at the Carlsbad facility and each refrigerator in the mobile labs. The attached
forms can be used for this purpose. Appendix 9A (1&2) and 9B is to be used for
documentation of the bay and in-house refrigerators/freezer and Appendix 9C, the
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excursion log, is to be used by the mobile lab chemists to document the mobile job
performed along with the refrigerator temperatures and the lab temperature for each day.
9.1.3 Instrument maintenance logs –
These logbooks are bound notebooks that have pre-numbered pages and are kept with the
specific instrument. The chemist is to document any procedure they perform to the
instrument including changes of operational gases and their lot numbers. Each event
should be dated and the reason for the procedure and the outcome. The chemist is to initial
each entry. After the maintenance/repair is recorded in the maintenance log book, if there
is not enough room at the bottom of the page for an additional entry, the analyst must close
out the page using a large “Z” at the bottom with their initials and the date that the page
was closed out.
The name and instrument ID# along with the serial numbers should be documented on the
inside cover of the notebook. The chemist can also use this book to document instrument
settings and parameters. When logs are completed, they are to be filed for archival
purposes in a central location designated by the quality assurance officer or laboratory
director.
9.1.4 Analyst Notebooks for Training
When an analyst is hired by H&P and begins their training, they may want to take notes to
record what they learn. These notes must be recorded in a bound notebook that has pre-
numbered pages. This notebook will be issued by the lab director and returned to H&P
when the analyst end their employment with H&P.
9.2 Laboratory Sample Data Packages
When samples are received in the field or in the fixed base lab, they are assigned an element job
number and a H&P project #. A project folder will be created by either the sample custodian or by
the field chemist. This package is to contain all the data and documents necessary to complete the
specific project.(See Section 8.2.1) Each project folder is to contain all pertinent information to
complete the analysis and prepare final data reports.
Data Packages include the following documents:
Tier 1 review form
Tier 2& 3 review form
Sample extraction and run logs
Sample Chromatograms
Sampling log sheets (vapor collection logs, if chemist/technician had sampled)
Chemist Project notes (Field Jobs only)
Sample Chain-of-custody (COC)
Job Confirmation Sheet (Field Jobs only)
9.2.1 Tier 1, 2 & 3 Review Forms –
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As part of the data review process described in detail in section 8 of this QSM, the analyst
must document the review of their data package by completing the Tier 1: Chemist/Analyst
Review Checklist, Appendix 8B. The QAO and Administrator must also document the
review of their data package by completing the Tier 2 & 3: QAO/Administrator Review
Checklist, Appendix 8C.
9.2.2 Sample Extraction/Run Log –
This daily analytical run log sheet is to be included in each data package for every analysis
type performed on the samples included. Attached in Appendix 9E-9M are H&P’s analyses
run log sheets. It has a tab for each analysis that is performed. It is formatted to enter via
the computer or to print out and hand enter. These log sheets allow the chemist to
document the standards used for initial and daily calibrations and spiking solutions used
for matrix or blank spikes. This log is to be completed in full before submitted for data
review. Please note that the "comment" column is meant as a tool to help track your
analyses status and is completely optional (prep, run, rerun, post...). Do not make changes
to the layout or appearance in order to have consistent log sheets company wide. A chemist
may make extra tabs for multiple standards for calibrations. The original spreadsheets are
to be maintained on the computer in each laboratory and copied for job files.
9.2.3 Sample Chromatograms –
For mass spec analyses, analytical runs should have “raw” (not reviewed) chromatograms
included in the project file. Due to the necessity for many manual integrations by the TO-
15 methods, it is acceptable to provide a “reviewed” chromatogram only as long as all
manual integration documentation is provided.The chemist must document that the
internal standards and surrogates are acceptable by using a check mark to indicate these
were evaluated. Any false positives on the chromatogram are to be crossed out. If the false
positive has acceptable retention times and qualifiers, a reason for the decision for a false
positive must be provided i.e.” peak not real”. For manual integration procedures see
section 9.9. For TPH analysis, only correctly integrated chromatograms need be included.
For all analyses, each run must be documented onto the sample run log (section 9.2.2) even
if it is not used or reported.
If a chemist is analyzing samples for more than one project folder, copies of the sample
extraction/run log and any relevant chromatograms must be made and included in each
package.
9.2.4 Sampling Log sheet (Field Jobs only) –
This sampling log is to be completed by any technician or chemist who collects soil, water
or vapor samples. Field technicians must fill out the appropriate log sheet for each type of
sampling matrices collected. Typically, chemists only collect soil vapor samples.
Therefore, a chemist will complete a soil vapor survey log sheet. This log sheet is to be
completed by hand and should thoroughly document all samples that were collected. Any
samples that were not able to be collected must also be indicated on this form and the
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reason listed under “field notes”. This log sheet is also not to be altered in any way for
consistency purposes.If corrections are required, the incorrect item is to be lined out with
a single line and the correct information entered accompanied with the corrector's initials
and dated as well as a reason for the correction (i.e. typo). See FMS 001 thru 012 for all
sample log sheets.
9.2.5 Chemist project notes checklist (Field Jobs only) –
This daily log is used by the QAO/data reviewer and billing department and is filled out by
a chemist and included in each data package. This log is used to document unusual
circumstances, changes in scope, exceptions, overtime, equipment problems, billable items
(Tedlars) and client field requests. The instrumental or analytical issues that occur in the
field are to be documented in detail on this form as well as the corrective actions that were
done to solve the issue. It should be clear as to how much downtime occurred and whether
the job was reassigned to another lab or was rescheduled. (See Appendix 9D1 & 9D2)
9.2.6 Sample Chain-of-custody (COC) -
This is not a log but a legal document that is completed for all samples relinquished to
H&P. Each COC may be several pages long depending on how many samples are
submitted for analysis for a project. Each COC set represents one work order and is
dependent on “date received by H&P”. For a project that involves a mobile lab being
scheduled for several days, a COC set is to be completed and a new element work order
generated for each day. Each page of the COC set must be signed as received by a H&P
employee and signed relinquished by the client. There are two types of CoCs, one to be
used for vapor samples, the other is to be used for water/soil samples.See section 7.1.1.1
for more instructions on COC completion. Appendix 6 A & B
9.2.7 Job Confirmation Sheet (Field Jobs only) –
This document is generated by the project manager and delivered to the field chemist and
field technician prior to the job. It includes all information relevant to the successful
completion of the project including analysis type, sample matrix, sample quantity, analyte
lists and reporting limits, start time, client name, project location, etc. This is to be kept in
the project folder to enable the data reviewer to determine if the project was completed as
specified. (See Appendix 6N1 & 6N2)
9.3 QA/QC Data
Quality control data are generated at the bench level and used to control ongoing operations. See
Section 8.0 for details. The operation controlled depends on data item in question. Instrument
calibration data and daily calibration checks, for example, are used by the instrument operator to
control the instrument and its operation.Once an instrument is calibrated, the calibration
summary along with the raw data blank test results, LOQ confirmations must be sent to the QAQC
officer for approval. Additionally, the calibration parameters must be provided (electronically by
email) to the QAO. An electronic copy of this calibration is also to be kept in the mobile
laboratory for reference. When a final report is generated the Data Reviewer verifies that all
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project data have been collected. These are inventoried and placed into the Project Data File for
future reference.
Other QA/QC data such as Method Detection Limit (MDL) studies, LOD/LOQ verifications,
Intralaboratory and Performance Testing (PT) study results are to be generated and then validated
by the QAQC officer or the laboratory director. The raw data for the MDL studies are maintained
by the QAQC officer or Lab Director. The PT studies, intralaboratory studies and LOQ/LOD data
are maintained by the laboratory director.
9.4 Validation Data
Validation consists of independently cross-checking calculations to assure that errors are not being
produced. All data are reviewed by hand prior to incorporation into Final Reports. Hand calculated
data are verified at a level of 10% by a second individual. Automated data processing results are
reviewed at a rate of 5% for all data generated using previously validated programs. An exception
to this is data processed using spreadsheet programs; these are validated by hand at a rate of 10%.
Any data processed using a new computer program or spreadsheet is validated at a rate of 100%
until all aspects of the process have been checked for correct operation. The data reviewer will
designate that a data set has been reviewed by checking the rough draft report.
9.5 Data Integrity
Data Integrity is maintained through the use of a multi-tiered approach. The levels can be stated
as
Maintaining confidentiality of data integrity issues
Personal ethics training and data integrity training for the employees and annual review of the
training.
A policy to require field technicians and analysts to seek advice from management for out-of-
control events or out of the normal results i.e., Analyst decision and/or sampling decisions.
Data review by independent personnel
Data review by upper management
Continuous review of data and a lookout for potential data integrity issues by the QAO and/or
Field Operations and QA/QC Manager. The Human Resource Manager is the designated
integrity officer.
If the QAO or Field Services Manager or Field QA/QC Manager find any evidence of a data
integrity issue, an initial audit is to be initiated to quickly determine root cause and to prevent re-
occurrence. All data integrity issues are to be discussed at managerial review meetings.
9.5.1 Ethics training
Ethics training is given to employees within a few days of their start date and on an annual
basis. This consists of a self-reading selection on ethics in the laboratory, a PowerPoint
presentation and a group ethics meeting with discussion. When they have read the
materials, they are asked to read and acknowledge understanding of several documents
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dealing with ethics in the laboratory or with sample collection in the field. These
documents are:
Company Data Policy
The use of an Ethics Hotline
Company Non-retaliation policy
The above documents are now included in the Employee handbook. Those documents
need to be signed as received and are kept on file. The employee is also to sign a statement
that they have had this training and understand the ethics policies (See Appendix 9R). The
signed documents are kept in the employee’s file.
Annual training shall include the following data integrity issues:
A definition of improper or unethical actions
A list of prohibited practices along with examples
Consequences of unethical behavior or infractions of the laboratory data integrity
procedures.
All employees are to be encouraged to contact the assigned integrity officer if any
unethical behavior is observed.
Final report location and processes (for those approved to review data)
9.5.2 Analyst and Field Technician Decisions
Field chemists and field technicians,may make certain decisions regarding out of control
situations. For example, running an additional 2 CCVs is permitted at the discretion of the
analyst. If ANY parameter remains outside of acceptable limits, the analyst is required to
contact the Lab Director or QAO for instructions on how to proceed. The Lab Director or
QA Officer may require such responses as recalibration, reanalysis of samples etc., to
correct out of control events.
9.5.3 Independent Data Review
Under no circumstances may a chemist perform a final review their own generated data.
The only exception to this is the generation of “Preliminary data” either in the field or in-
house. Data integrity is maintained if the review is done by an independent person.
9.5.4 Data Review by Management
Upper management will review and sign final reports independent of the peer level data
reviewers.
9.6 Data and Field Sampling Integrity Issues
Data shall be produced according to the project specific requirements as specified in the final,
approved project planning documents such as the approved QAPP, when these documents are
provided to the laboratory.
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Improper actions are intentional or unintentional deviations from contract specified or method
specified analytical practices that have not been authorized by DOD or another accrediting agency.
Unethical or illegal actions are the deliberate falsification of analytical or quality control results
where failed method or contractual requirements are made to appear acceptable.
9.6.1 Initial evaluation
Any employee may bring issues of data integrity to the attention of the management.
Questions concerning data integrity are encouraged prior to issuance of data to clients so
that resolutions can be accomplished in the simplest manner possible. For the analysts and
data reviewers the Laboratory Director or Quality Assurance Officer can be the first point
of contact on such issues. For field sampling technicians or field chemists doing field
sampling, the first point of contact can be the Field Services Manager or Field QA/QC
Manager.The final decision as to whether or not corrective action or policy change is
appropriate is the responsibility of the President.
9.6.2 Corrective Action
If the Laboratory Director,Field Services Manager or Field QA/QC Manager decides that
corrective or disciplinary action is necessary, they will see that appropriate parties are
informed of the action warranted. This may be limited only to a single employee, who
may receive a memo as to the out of control event. It may involve a companywide policy
change or it may reach any client affected. The Laboratory Director and QAO will
document the issue as appropriate and keep records of such actions. Memos to employees
are to be stored in the personnel file as well as a separate Data Integrity issues file. Records
of these events will be kept on file for a minimum of ten years.
9.7 Electronic Transmission of Data
Once the analyst has completed sample analysis and reviewed the sample data, they may send
preliminary data to the client. All data entered in the Element LIMS system is to be checked for
RED flags which will indicate that there is a problem with the data. Any problems must be fixed
before the data is locked and status changed to analyzed. The analyst can then generate a draft
report which includes the cover page to the appendix page. The preliminary report is to be saved
on the server under preliminary data and the specific laboratory. The analyst should always verify
that the preliminary report has:
Correct analyte list and reporting limits
No false positives or false negatives
The correct project name and project manager
Acceptable QA/QC
Preliminary data is preferred to be sent by email. The preliminary email template is to be used to
email clients. A copy of this email is to be sent to the H&P project manager; all other H&P project
managers and the laboratory director are to be “blind’ copied as well.
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Final reports are to be sent by email. Final reports are kept on the server in a Final Report Folder
(i.e. 2020 Finals) that has limited access. Access to this folder is provided by the IT Manager. For
the purposes of generating, reviewing and saving data, the following personnel have access to the
LIMS: Mobile Lab and Fixed Base Chemists, Laboratory Director and QAO. For the purposes of
finalizing and transmitting data, the following personnel have access to the final reports directory:
Laboratory Director, QAO, Project Managers, IT Manager and Data Reviewers. Any H&P
personnel that review and/or finalize analytical data are trained to save final data to the final report
directory. Additionally, all appropriate personnel are trained on the process of naming revisions
and adding a statement, to the revised report, that indicates what has changed. Revised final
reports will be named with a “Rev” in the final report folder. Once a final report has been
provided to a client it is not to be altered, and if a revision is needed, the report and file should
include ”Rev”. Documentation of this training is located in the employee’s training file and is
updated annually as part of H&P’s lab ethics and training program.Email transmission of client
data by electronic means should contain a statement similar to what is listed below:
“This message is only intended for the addressee. It contains information that is confidential and
may be protected by copyright and/or attorney-client privilege. If you are not the intended
recipient, please notify us immediately and destroy this message.”
9.8 Data Levels
Our standard final report is considered a level 2 data deliverable. Many times, a client may request
a higher data level to be submitted for a specific project. This information will be specified in the
job confirmation sheet for field job and on the COC for in-house work. The following data must
be included with the final report for the data deliverable level below.
All reports are to:
Be paginated with all pages numbered
Have client name, address and client project number
Have H&P’s name, address and title of signatory person
Have a cover sheet with table of contents
List of all samples submitted
Have a narrative listing non-conformance(s), problems with data, and other out of the
ordinary occurrences and/or qualified data. For DOD reports, if requested by the client, all
manual integrations should be summarized
Have a QA/QC section containing method blank and spike data including QA/QC limits
Have sample results and units
Show surrogate recoveries with QA/QC limits
Have an Appendix that defines all data qualifiers used
Have all emails and documented phone calls included in Appendix of report (For DoD
reports only) if requested by the client
Include the following statement, “H&P Mobile Geochemistry, Inc. is certified under the
California ELAP and National Environmental Laboratory Accreditation Conference
(NELAC) for the fields of proficiency and analytes listed on those certificates. H&P is
approved as an Environmental Testing Laboratory in accordance with the DoD-ELAP
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Program and ISO/IEC 17025:2005 programs for the fields of proficiency and analytes
included in the certification process and to the extent offered by the accreditation agency.
Unless otherwise noted, accreditation certificate numbers, expiration of certificates, and
scope of accreditation can be found at: www.handpmg.com. Fields of services and
analytes contained in this report that are not listed on the certificates should be considered
uncertified or unavailable for certification.”
9.8.1 Data Deliverable Level 3-
Summary of initial calibration
Summary of daily CCV evaluation
Analytical Run Log
Internal Standard Summary sheet (8260/TO-15 only). This summary sheet is to be
created on the Chemstation software by the chemist. See procedure in Appendix 9O.
9.8.2 Data Deliverable Level 4
Summary of initial calibration and chromatograms
Summary of daily CCV evaluation
Tune summary
Analytical Run Log
Internal Standard Summary sheet (8260/TO-15 only). This summary sheet is to be
created on the Chemstation software by the chemist. See procedure in Appendix 9O.
Detailed Report Chromatograms (8260/TO-15 only) with all false positives Q-deleted
for all samples, blanks, CCVs and QA/QC samples.
9.9 Manual Integration of data
9.9.1 Reasons for Manual Integration (GC/MS Methods)
It is the responsibility of the analyst to evaluate their data and thoroughly review the
instrument-generated data before reporting it. When the software identifies a hit on the
chromatogram, it is advised that the chemist investigate if the software was correct in the
integration and identification of the analyte. Many times, the software will select the
wrong peak or set the baseline incorrectly, or there are other peaks that interfere with
proper integration. Manual Integration may be necessary and is defined as the process by
which an analyst can reset the baseline of a peak during reprocessing and quantitation such
that the baseline is different from the original automated process set by the run parameters.
The following items are acceptable reasons for using manual integration:
Peaks are split by chromatography software
There are well-defined peaks on the shoulders of other peaks
Baseline noise: Signal-to-noise ratio is less than 3:1
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There are negative spikes in the baseline
There are rising or falling baselines
The wrong peak is identified by the chromatographic software
9.9.2 Documentation of Manual Integration
Extreme caution is required when using manual integration, particularly when the
integration affects method compliance. Every manual integration must be documented in
the data package and the technical justification provided. Once a peak is integrated
manually the software puts a “M” footnote next to the result which indicates that that peak
was manually integrated. The analyst is to cross out the original concentration value of the
analyte being manually integrated on the “raw” quantitation report and write next to it the
revised manually integrated value. This report should state “Not Reviewed” on the top.
(see Section 9.2.3 for TO-15 exception). The analyst is to attach the before and after EICP
print out or a blow up of the integrated peak and attach it to the quantitation report. The
“Reviewed” quant report need not be included unless the manual integration was
performed on an internal standard compound. Sign, date, before and after chromatograms,
and include a reason for performing the manual integration.
9.9.3 Manual Integration Procedures
To carry out a manual integration one must consider the chromatographic baseline and the
start and stop points of the peak along the baseline. When manual integration is used, it is
best to zoom in on the baseline and use a display window of less than 0.5 minutes.
Determine the average noise level of the baseline. Set the start and stop points for the peak
at the average noise level of the baseline. Manual integration should only be used when
peaks are clearly resolved with a valley between the peaks.
The analyst can also check on how problem peaks are integrated automatically during the
calibration. They should attempt to perform the manual integration on sample
chromatograms as similar as possible to way it was performed on the calibration
chromatograms.
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Examples of proper and improper integration:
Incorrect Integration Correct Integration
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Automatic Integration Incorrect Integration Correct
Integration
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10.0 Document Control
Document control is the process by which the documentation associated with samples and sample data are
tracked and monitored. It also is the process of how the SOPs and the QSM, and its appendices, are
modified, distributed and tracked. The process includes a document control procedure, assignment of a
responsible individual to see that the system is being used properly. The various aspects of the document
control system are described in detail in this section
10.1 Project Specific Document Control
The Document Control Officer maintains document files for each active and completed Task. A
document file consists of all final documentation material connected with the samples in a Task
including chromatograms, QC data and reports, final data sheets, billing, and ongoing standards
analysis data. Also included are such things as chain-of-custody records, sample receipt logs,
sample check-in/out logs, extraction logs, and GC/MS run logs. All emails are kept in electronic
form only.
10.2 General Laboratory Documents
The Document Control Officer maintains general lab document files for general lab task and
quality control. Document files consist of material connected with the samples in a peripheral
manner including but not limited to refrigerator logs, extraction logs, field logs, blank studies,
MDL studies, chromatograms, QC data and ongoing standards analysis data.
All entries in laboratory notebooks laboratory and field logs, and raw data are to be made in blue
ink. If corrections are required, the incorrect item is to be lined out with a single line and the
correct information entered accompanied with the corrector's initials, date and the reason for the
correction (i.e. typo). Under no circumstances can “white-out” correction fluid be used to make a
correction on any document. When a notebook has been completely filled in it is given to the
Laboratory Director for filing.
All raw GC and GC/MS data are to be stored on the hard drives of the computers which control
the instruments until reports are complete. They are then archived, along with all used laboratory
notebooks, by the laboratory director for ten years. The raw data shall be archived using the
archival method available on the computer that controls the instrument. All data and methods are
to be saved onto DVDs
10.3 Quality Systems Manual (QSM), SOPs, and Associated Forms
H&P’s QSM and SOPs shall be maintained in a format that records the effective date and revision
date. The QAO, laboratory director and Field QA/QC Manager shall review them on a yearly basis
at a minimum to ensure that QSM and SOPs are the most current and correct. They are also to be
evaluated as to their suitability and compliance with all QA/QC requirements. The Lab Director
and Field QA/QC Manager are to ensure that the SOP for the standard methods are based upon the
most recent version of that method.
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During the year, the QAO, Lab Director or Field QA/QC Manager may “hand-write” changes onto
the original hard copies of a SOP or the QSM. These changes are to be signed and dated. Once a
SOP or the QSM is finalized, it is to be reviewed and signed by both the QAO and Lab Director or
the Field QA/QC Manager, as appropriate. All changes to the QSM and to method SOPs are to be
clearly indicated. Additions are to be set to bold print and removed text is to be struck through.
This does not apply to changes in the Table of Contents. All SOPs, log sheets, calculation sheets,
appendices and the QSM must have the Revision #, revised date and effective date listed. All
these documents must be paginated or otherwise suitably marked so that the end of the document
is clear. The old electronic versions of the SOP and QSM will be transferred to an electronic
folder labeled as “OLD SOPs” or “OLD QSM”. The revised, approved and signed versions will
be kept in a “current” electronic folder labeled with annual date. All revised, approved and signed
SOPs and QSM and appendices will be distributed electronically to all analysts, field technicians
and laboratory personnel. The Lab Director or Field Operations and QA/QC Manager must obtain
documentation from each person, to which the document was distributed to, that they read,
understand and agree to follow or use the document. This distribution is recorded onto a
Document Distribution List Appendix 10A. The QAO, Lab Director or Field Operations and
QA/QC Manager will maintain a master list of all Quality documents and ensure that the most
current documents are available for distribution. The most current versions of the SOPs and QSM
are also made available to all laboratory and field personnel on the H&P server.
As part of the document control and security, H&P ensures that Excel spreadsheets are
appropriately managed. Calculation spreadsheets, such as LOD/LOQ spreadsheets have columns
that contain formulas, which are locked so that the formulas cannot be altered upon data entry by
analytical personnel. Following submittal of Excel Spreadsheets, such as the quarterly LOD/LOQ
sheets, the Lab Director or QAO must write-protect the entire spreadsheet to prevent inadvertent
changes and will be saved appropriately. For example, quarterly LOD/LOQ verification
spreadsheets will be locked and renamed “TO-15 SV LOD-LOQ-3rd QTR LOCKED.xls upon
submittal and saved in a folder on the server with limited access. Locked spreadsheets must be
saved in the Lab Director Folder located in the Management drive. Only the Lab Director and
QAO have access to write protected spreadsheets. The IT Manager controls the access to the
Management drive.
10.4 Document Records
H&P retains hardcopy reports, data and logs for a period of at least ten years. Electronic data files
are backed up on a bi-annual basis. The Lab Director stores all the raw data files.Electronic data
is currently kept indefinitely. In the event of transfer of ownership all data files will be transferred
to the new owner. In the event that H&P goes out-of-business, all clients will be notified by email
that the laboratory is closing and they may retrieve their project files within 30 days or they will
be shredded.
10.5 Document Security
H&P considers all laboratory data associated with projects to be the property of H&P. The client
is entitled to all forms of reports including but not limited to copies of everything produced during
the project. H&P reserves the right to maintain original records of the projects. Toward that end
client confidentiality is to be maintained. No data or information is supplied to third parties
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without the consent of the client. The obvious exception is the subpoena of H&P’ data by law
enforcement and/or authorized representatives of accrediting government agencies.
All data associated with client projects and laboratory traceability are kept securely stored on-site.
Document storage locations are to be locked with controlled access. Employees seeking access to
these records must sign and date a Project Report Checkout Sheet (Appendix 10A). Once data has
been finalized in LIMS, the data is locked and can only be unlocked by authorized H&P
personnel. The IT manager provides access to lock (or unlock) electronic data in LIMS to specific
H&P personnel. Any H&P personnel that review and/or finalize analytical data are trained to save
final data to the final report directory. Documentation of this training is located in the employee’s
training file and is updated annually as part of H&P’s lab ethics and training program. As
mentioned previously, for the purposes of finalizing and transmitting data, the following personnel
have access to the final reports directory: Laboratory Director, QAO, Project Managers, IT
Manager and Data Reviewers.The security of all documents is the responsibility of the
Document Control Officer.
Once data is released for destruction after 10 years, they are to be shredded
10.6 Confidential Handling
All information related to customers, their samples or the data associated with their samples is
confidential. It is not to be discussed with anyone outside the lab other than the customer.
Exceptions to this are acceptable only if the customer so specifies in writing.
10.7 Certifications
All documentation that pertains to the certifications held by H&P Mobile Geochemistry, Inc.
from CA ELAP, DoD, NELAC and other states, are to be maintained by the laboratory director.
The originals are to be displayed in the lobby of the Carlsbad facility. Copies of these
certifications are held on the server and by the laboratory director. Each mobile laboratory will
also post a copy of their certification on the wall.
10.8 Field Sample Collection Records
H&P considers all Field Sampling data associated with projects to be the property of H&P. The
client is entitled to all forms of field log sheets generated, including but not limited to copies of
everything produced during the project. Hard copies of field logs are not to be copied or
duplicated in the field and are to be submitted to H&P headquarters for review upon completion of
project. H&P reserves the right to maintain original records of the projects. Toward that end client
confidentiality is to be maintained. No data or information is supplied to third parties without the
consent of the client. No electronic or photographic records of field activities are permitted for
field technicians except for draft data from any field analysis.
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11.0 COMPLAINTS, AUDITS, MANAGEMENT REVIEWS, NON-CONFORMING WORK,
PREVENTATIVE & CORRECTIVE ACTION
H&P is a company that is proactive at ensuring that they provide the highest quality data and services to
their clients. The steps to being proactive are:
Handling customer complaints immediately and effectively
Taking steps to prevent problems by taking Preventative Action
Fixing problems immediately and effectively by taking Corrective Action
Auditing laboratories and data packages and taking Corrective/Preventative Action because of
findings
Auditing management and overall laboratory/sampling activities, quality systems and
effectiveness of preventative/corrective actions
The following sections describe how H&P performs all these steps.
11.1 Customer Complaints
At all times, it is the policy of H&P is to be responsive to client wishes in terms of project
requirements. H&P will do everything in its power to satisfy client requirements as long as they
do not conflict with the company data policy, regulatory requirements or are in any way, unethical,
deceptive, fraudulent or illegal.
If H&P receives a verbal, telephone or email complaint from a client, the individual, must
immediately inform a supervisor or project manager of the complaint. The supervisor or project
manager will make a decision to initiate action and may inform the QAO of the issue. Usually the
project manager will immediately contact the client to determine the reason for the complaint and
to discuss the possible resolution of the problem. The project manager may ask the Lab Director,
Field Services Manager or Field QA/QC Manager or QAO for help in resolving the issue. It may
be necessary to pull data, sampling or report records for investigation purposes. Once the problem
is resolved, the reason for the problem may initiate a Corrective Action to prevent the problem
from reoccurring. A Client Service Form (Appendix 11A) or similar form will be used to record
the complaint, the resolution or corrective action taken, and client response with follow up.
11.2 Internal Audits
The purpose of this section is to describe one of the two types of audits/reviews that are performed
at H&P This section will also describe the responsibilities, the process, and corrective action
procedures for internal QA audits.
11.2.1 Types of Internal Audits
There are two main types of audits that are performed at H&P:Performance
Audit/Evaluation Audits and Quality Systems Audits. The first type is a Performance
Audit/ Evaluation which checks the performance of technicians and/or chemists who
perform either analytical or mechanical functions. The laboratory director, senior chemist,
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the Field Services Manager,Field QA/QC Manager or senior technician may perform these
audits. Another type of Performance Audit/ Evaluation audit is a data review audit, which
is performed by the QAO to ensure that the data packages are acceptable and that the
analytical protocols are followed.
The second type of internal audit is a Quality Systems Audit which is performed by the
QAO and the laboratory director. This audit will verify that the requirements in the H&P’s
QSM are being met.
11.2.2 Internal Audit Responsibility
It is the responsibility of the President to see that internal audits are conducted and that any
problems identified are solved through the application of appropriate corrective actions.
Performance Audits/Evaluations and Quality Systems Audits are to be conducted no less
than once per calendar quarter. The president is to be informed by the QAO if there is any
evidence of data integrity issues. An internal audit will be performed as a result and these
issues are to be discussed during the managerial reviews.
11.2.3 Internal Audit Process
The QAO, Field Services Manager,Field QA/QC Manager or the laboratory director may
initiate a Performance Audit/Evaluation on an analyst or technician. An audit schedule is
to be prepared at the beginning of each year that lists each analyst, mobile laboratory, drill
rig and stationary laboratory and when the audit is planned to take place. Strict adherence
to this schedule is not required but an attempt shall be made to follow the schedule as
closely as possible.
The audits may include the actual review of their analytical or mechanical procedures, their
knowledge of QA/QC criteria, inspection of their work areas or review of their
documentation. The mobile laboratory or drill rig may also be inspected during an internal
audit of a field analyst or technician. Documentation of this audit will be on either the
Performance Audit/ Evaluation Forms (Appendix 11BIAF-11EIAF or 11I-K). The results
of all internal audits are to be kept on file by the Laboratory Director or Field Services
Manager or Field QA/QC Manager.
For the Quality Systems Audit, any documentation, procedures, corrective or preventative
actions that were reviewed, modified, updated or finalized during the year may be placed
into a Quality Systems Review File. These items can be discussed during the Quality
Systems Audit. The findings resulting from this audit and any necessary corrective actions
are to be documented on the Quality Systems Audit form, (Appendix 11H)
11.2.4 Preventative/Corrective Actions following Internal Audit
If the results of an internal audit should indicate that all evaluated areas are not
satisfactory,preventative, or corrective action must be taken. These corrective actions are
to be described in detail and should have an expected due date indicated.
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For Internal Audits, the person completing the corrective action typically will be the
analyst or technician being audited. However, the preventative or corrective action may be
that the analyst or technician requires additional resources or training, which would
indicate that the corrective action be a group effort between the analyst/tech and their
supervisor. The performance and completion of any preventative or corrective actions must
be recorded onto the original audit form used. If the result of an internal audit is found to
effect client data, the client shall be notified immediately. The Laboratory Director, QAO
or Field Services Manager,Field QA/QC Manager or Project Manager, is responsible for
informing the client of the out-of-control event.
11.3 Managerial Reviews
The purpose of this section is to describe the responsibilities, the process, and corrective action
procedures for Managerial Reviews.Management reviews are conducted to review the
laboratories quality systems and environmental sampling techniques to determine if they are
effective, accurate and still provide our clients with the highest quality data. A management
review may be conducted to resolve a problem, update services, discuss safety issues, improve
communications, to discuss training needs or to set company goals. Other items discussed may be:
The suitability of policies and procedures
The outcome of internal audits
New sampling and analytical procedures
Customer Complaints and feedback
PT sample results
Effectiveness of Preventative/Corrective Actions
Services offered (Volume & Type)
Assessments by external bodies
Reports from supervisors/managers
Internal Audits
Performance testing
Any ethics or data integrity issues
Any officer of H&P, or supervisor, may request a Management Review at any time but at least one
Management Review must be performed annually. The final outcome of this meeting may result
in a preventative or corrective action to be initiated, to set a goal or achieve a desired outcome that
will ultimately improve the quality of the services offered by H&P. The documentation of this
audit will be listed on the Management Review and Action Form (Appendix 11F). The person
requesting the Management Review meeting is to document the details of the discussion and
findings onto the Management Review and Action Form. The form is to be completed in full
outlining the specific areas of discussion and the list of required preventative/corrective actions to
be performed by whom and by what date. This documentation is to be filed with the Laboratory
Director.
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11.3.1 Managerial Review Responsibility
It is the responsibility of the President to see that managerial reviews of the Quality System
are conducted and that any problems identified are solved through the application of
appropriate corrective actions. Reviews are to be conducted on an as needed basis but no
less frequently than once per calendar year.
11.3.2 Managerial Review Process
The predetermined time for Management Reviews are at the beginning and mid-point of
each year. Managerial Reviews are requested by an H&P officer when the need to discuss
items listed above are deemed necessary. A review will be conducted if there is evidence
of inappropriate actions or procedures or vulnerabilities in respect to data or sampling
quality. Each review must also discuss past Managerial Reviews and outcomes and
whether the preventative/corrective actions taken were effective and/or completed.The
company officer will enlist the assistance of the QAO for the Review.
11.3.3 Preventative/Corrective Action following Managerial Review
If problems or potential problems are identified it is the responsibility of the Lab Director,
Field Services Manager, Field QA/QC Manager or the QAO to see that appropriate
preventative/corrective action is taken and that the corrective is performed in a timely
fashion. In general, the result of the managerial review will result in a revision of
documents for the quality system including, but not limited to the QSM and all company
SOPs. It is anticipated that all documents will be reviewed at the same time so that all
changes may be incorporated into all documents and distributed to personnel
simultaneously.
11.4 Control of Non-Conformances
During analysis, situations may arise that result in data being non-compliant to the standard
operating procedures dictated in the QSM or in the method SOP. A non-conformance may also
mean that the data generated will not meet the client requirements for the project. The same
applies to sampling operations as well. The responsibility for identifying non-conformances starts
with the sampling personnel and/or the analyst. Once a technician or analyst observes a non-
conformance, they are to contact their immediate supervisor within 1 hour if the issue continues
and cannot be resolved. For example: If the analyst is unable to maintain the laboratory
temperature within the required limits, they are responsible for informing the Lab Director
immediately. Once the supervisor is informed, the following information is to be assessed:
Can the non-conformance be fixed or changed by corrective action?
Is the data or sampling quality being affected and to what degree?
Should the work be stopped and rescheduled?
The responsibility for obtaining this information lies with the laboratory director,Field Services
Manager, and/or Field QA/QC Manager. It is ultimately up to the Lab Director, Field QA/QC
Manager and project manager to make the decision whether work is to be stopped and
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rescheduled. It may be necessary to inform the QAO as well depending on the circumstances. For
some situations, it may be decided to inform the client at this time to allow them to make the
decision to stop work, based upon the information collected. Regardless of the outcome, if the
situation indicates that the non-conformance will continue, the job is to be rescheduled.
During the data review process, it may be determined that the data quality or sampling procedures
did not meet data quality requirements or that sampling/analytical procedures were not followed.
This may be noted in the chemist lab notes or sample collection logs. The problem may have been
found during evaluation of QA/QC results for a project. This would be an instance where the
analyst or tech did not realize that the situation was a problem or if approval was provided to them
to proceed by their supervisor. The QAO, Field Services Manager, and/or the Field QA/QC
manager will review the data and sampling logs to decide whether data quality was affected and to
what degree. At this time, the laboratory director or Field QA/QC Manager may be consulted. If
the data quality is not affected, the QAO may choose to document their findings only. If the data
quality is affected, it is up to the QAO to decide whether the effects on the data quality are
significant enough to bring this to the attention of the Lab Director and project manager. The
following must be determined:
How significant is the data result effected and to what degree?
How relevant is the analyte that is in non-conformance?
Could this impact decisions made in the field by the client?
Should preventative/corrective action be initiated?
Depending on the findings, the QAO may choose to flag or qualify the data or if sampling related,
the Field QA/QC Manager may choose to address the issue on the sampling log or with the client
directly. If the situation indicates the analyst or tech requires retraining or further instruction a
preventative/corrective action will be initiated. If the findings are significant and it could impact
decisions that are made in the field, the client will be contacted within 5 working days and
restitution made as soon as possible.
11.5 Preventive Action
Preventive action is any proactive methodology used to determine potential discrepancies before
they occur and to ensure that they do not happen (thereby including, for example, preventive
maintenance, management review or other common forms of risk aversion
To accomplish this, the following actions are performed on a regular basis.
Continuous feedback from H&P project managers to analysts and technicians on
our performance. Feedback is documented in personnel files.
Regularly scheduled training sessions for chemists and technicians on new and
improved procedures for sampling and analysis.
Regularly scheduled safety meetings to prevent accidents, close calls and improve
safety overall.
Management meetings set to discuss future goals and potential new services.
A team approach to solving problems whereby the input from all personnel is
welcomed and encouraged.
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A team approach to solving quality issues whereby the QAO and Laboratory
Director work closely together and involve the President in their decisions and
actions.
All Preventive Actions are to be documented onto a Corrective/Preventative Action Form
(See Appendix 11G).
11.6 Corrective Action
A corrective action is the action taken to eliminate the causes of an existing non-conformity,
defect or other undesirable situation in order to prevent reoccurrence. Normally corrective actions
are implemented in response to a customer complaint, abnormal levels of internal nonconformity,
nonconformities identified during an internal audit or adverse or unstable trends in product and
process monitoring.
It is the responsibility of the QAO to see that corrective actions are implemented. The Lab
Director, Field Services Manager, analysts and data review personnel should make the QAO
aware of any departure from method procedures or QC control parameters as soon as possible.
The QAO, Lab Director or Field Services Manager (if sampling related) will then make any
adjustments and inform the staff of the change or corrective action. If a problem is observed
during drilling or sampling operations, a technician or the Field Services Manager may initiate the
corrective action. In general, a corrective action can and should be initiated by any analyst,
project manager, QAO or technician when a situation or an occurrence happens that will
ultimately affect data quality, project deliverables or otherwise diminish the quality of service to
the client. In summary, if a problem is observed, corrective action is to be initiated to solve it.
An analyst, technician, supervisor, or data reviewer upon noting a departure from method or QC
parameters initiates corrective actions. The corrective action is initiated by filling out the
corrective action form. See Appendix 11G – Corrective/Preventative Action Form. Each
corrective action shall start with an investigation to determine the root cause (s) of the problem.
The next person up the review chain (i.e. peer reviewer or supervisory review) will make a copy of
the form and make the QAO and/or the Lab Director/ supervisor aware of the need for corrective
action. The QAO will oversee ensuring that the corrective action is complete at which time the
copy of the corrective action form is returned to the file with the solution. The higher the
magnitude of the problem, the faster the corrective action is to be implemented. In this manner, a
file will not be deemed complete unless a copy of the corrective action form is contained in the
data file. The file will remain “open” until such time as a solution to the corrective action is in
place. Once a corrective action has been completed, a follow-up is to be done within a year to
determine if the corrective action has been effective. The follow-up findings are to be documented
onto the original corrective action form.
The analyst has the authority to perform any changes that are allowed under the method (e.g.
perform 2 additional CCVs under EPA/H&P Method 8260 if the first does not pass) or to place
laboratory authorized data flags to data that is out of QC control limits (e.g., add an “E” flag to
over calibration curve data). These should be documented in the raw data package and/or the run
logs. Data that contains out of control QC should be reported to clients with “flags”.
Only the Lab Director or QAO has the authority to override method permitted changes to the data.
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12.0 SAFETY
The purpose of this section is to outline H&P Mobile Geochemistry Inc.'s safety practices. It addresses
general laboratory safety, safety requirements for equipment operation and for chemical handling and
storage. For more details, refer to the following H&P resources: Company Health and Safety Program;
Company Injury, Illness and Prevention Program; and The Company Employee Handbook.
12.1 General Laboratory Safety
12.1.1 Responsibility
Safety in all aspects of the H&P workplace is the responsibility of every employee. All
personnel are to familiarize themselves with the contents of this section and police other
employees to be sure the procedures are being followed. Authorized visitors and
subcontractors in the laboratory are also expected to be aware of and follow the
procedures.
12.1.2 Drugs
Under no circumstance are persons in the possession of or under the influence of mind-
altering drugs or alcohol permitted in H&P or its laboratories. Being under the influence of
or in the possession of such drugs and alcohol and/or the failure to report anyone under
their influence or in their possession constitutes grounds for immediate dismissal. Details
of this procedure are defined in the employee handbook.
12.1.3 Compliance
Drug and alcohol testing are required by client companies and as part of H&P’s company
policies. Employees are subject to the requirements and rules as discussed in the H&P
employee handbook. These include but are not limited to pre-project drug testing, and
post-accident investigation testing. Employees are expected to give full cooperation in
conducting testing under their programs. Failure to cooperate with clients and/or H&P will
be deemed as grounds for dismissal.
12.1.4 Dress
The purpose of this section is not to establish a dress code for employees. However, the
proper choice of attire will enhance the effectiveness of safety equipment in the event of an
accident. Shorts, skirts, and short-sleeved shirts are acceptable in the lab when work in
process involves only instrumentation and inert solvents. They are acceptable under other
circumstances when worn with lab coats. Bare feet or any form of open-topped shoes are
not acceptable laboratory or field attire.
Mobile lab chemists and field technicians are required to have level D PPE with them at all
project sites.These safety supplies are supplied by H&P.
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12.1.5 Safety Glasses
The use of safety glasses is mandatory at all times in the laboratories when using solvents
and when changing any cryogenic or high-pressure gas cylinder.Safety glasses will be
provided for laboratory personnel and visitors entering the laboratories. Safety glasses are
required when handling water samples as they contain acid for preservation.
12.1.6 Lab Coats
All laboratory personnel will be provided with coats and aprons if needed. These garments
shall be made of a chemical resistant material and provide protection for the arms, legs and
body. They should be worn any time an individual is in a space where liquid is being
handled in sufficient quantities such that if spilled onto the individuals clothing, it would
soak through to the skin. When personnel are sitting at a bench and handling chemicals or
sample extracts, a laboratory coat or apron of sufficient size to cover the thighs should be
worn. Solids even in small quantities, may pose a hazard if they work their way to the skin.
Laboratory coats and aprons should not be laundered with personal clothing.
12.1.7 Respirators
Organic/Acid respirators will be provided for use by employees.Per H&P’s Respirator
Fitness Program, chemists and field technicians will be fit-tested yearly. They should be
worn by personnel in the following cases:
a. When handling potentially hazardous volatile organic compounds,
b. When handling concentrated acids in open containers away from the hood,
c. When working with materials that have the potential of off-gassing hazardous fumes
either spontaneously or when mixed with other materials, and
d. Any time there is any doubt with respect to the quality of the air in a work area.
Generally, if the work of an individual in an area requires a respirator, then all personnel in
that area should wear a respirator.
12.1.8 Gloves
Personnel are required to wear gloves when handling open containers of chemicals or
contaminated glassware, wiping down counter tops, washing glassware, dispensing
chemicals or otherwise risking exposure to hazardous substances. Gloves should be
washed with soap and water before removing to prevent contamination of the skin. H&P
will provide gloves that can be used with the chemicals that are used. These are typically
powder free nitrile gloves.
For drilling operations, employees must use leather gloves to prevent injury when handling
heavy equipment. For sampling operations, nitrile gloves can be used unless the client
requires cut resistant Kevlar gloves.
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12.1.9 Housekeeping
The cleanliness of offices and laboratories is the responsibility of individuals working in
those areas. Floors are to be kept free of filth and trash. The placement of supplies,
equipment and personal items on the floor is to be avoided. Aisles shall be kept clear at all
times. Electrical cables, when routed across an aisle, are to be covered or barricaded at all
times. Access to emergency equipment such, as fire extinguishers, eyewashes, showers,
etc., shall not be obstructed. Waste and scrap shall be discarded in the appropriate provided
containers. No liquids or chemicals are to be placed in wastebaskets.
Mobile lab chemists are to follow Appendix 3C when assigned to clean their laboratory.
To clean the outside of the laboratory, a carwash that has the clearance to accommodate the
height of the lab without damaging the AC units on the roof is to be used. If such a
carwash is not available, the chemist may get approval to have the lab washed by a RV
repair center.
12.1.10 Personnel Access to Facilities
Routine access to Company facilities is limited to Company employees. All visitors to the
facility are to be accompanied by a Company employee. Keys to the facility are not to be
duplicated or loaned to others. There shall be a minimum of two persons present in the
laboratory when potentially flammable, explosive, corrosive, toxic or hazardous materials
are being handled.
12.1.11 Food and Drink in the Laboratory
All analysts are to avoid bringing food and drink into the laboratory areas. However, it is
acceptable if the analyst keeps the food and beverages at the desk area of the laboratory
where no chemicals are present. At no time is food or drink to be stored in laboratory
refrigerators designated for samples or chemicals. Some refrigerators may be designated
as food and drink refrigerators. Chemicals, samples or extracts are never to be placed into
these special designated refrigerators.
12.1.12 High Pressure Cylinders
High pressure cylinders are used in the operation of the analytical instruments and in the
field to purge tubing or in leak check procedures. Cylinders of compressed, liquefied or
dissolved gases shall be stored in the laboratory with a firmly anchored protective strap to
stabilize them in an upright position. Cylinders must be transported with the safety cap
firmly attached. Regulators, valves and fittings must be selected in accordance with the
manufacturer’s recommendations. All fittings on oxygen and other oxidizing gases are to
be kept free of oil and grease. The contents of all cylinders are to be clearly identified with
appropriate markings and/or colors. Pressurized gas cylinders shall not be used without the
appropriate regulators or pressure reducing valves.
All chemists and technicians are to use caution when handling these tanks. Safety glasses
must be used at all times when installing or operating these tanks. When installing a
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regulator on a tank, the secondary stage pressure control knob is to be set to fully closed
position (fully counter clockwise). Ensure beforehand that the correct regulator is being
used for the gas in the tank. Use the correct tool to tighten the regulator and open the main
valve of the tank. NEVER stand directly in front of the regulator’s diaphragm when
opening the tank. Using the second stage pressure adjusting control knob, increase
pressure to desired level. Use snoop or other means to ensure tank does not leak. To
remove a regulator, close the tank’s main valve and then fully close the second stage
control knob. Using a wrench, slowly remove the regulator off the tank. Some
compressed gas will be expelled after which the regulator can be safely removed.
12.1.13 Cryogenics
Cryogenics are used in the operation of TO-15 instrumentation. Cryogenic liquids can be
dangerous due to their extremely low temperatures. Insulated gloves and safety glasses are
to be worn while installing or handling cryogenic tanks or while transferring cryogenic
liquids to alternative containers.
12.2 Equipment Operation
12.2.1 High Voltage Systems
The maintenance of high voltage circuits is limited to properly trained personnel who have
been approved by Company Management. High voltage operating procedures will be as
recommended by the equipment manufacturer and no equipment will be used in modes for
which it was not intended. All high voltage equipment will be properly grounded at all
times. Dangerous voltage or current configurations shall be protected by a substantial
physical enclosure at all times.
12.2.2 Electrical Systems
Where electrical hazards exist first-line and back-up protection shall be provided to prevent
personnel access to energized circuits. Periodic tests shall be established to verify that
protective systems are operative. Whenever possible these protective systems shall be
designed to be fail-safe. Proper warning signs shall be provided to indicate the nature of a
hazard, its exact location and the proper actions necessary to avoid the hazard. Operating
and maintenance personnel shall be made aware of all circuit breaker, cut-off switch and
emergency de-energizing device locations. Fuses, circuit breaker and built-in system safety
provisions shall not be by passed. Particular care shall be taken to insulate all circuitry
correctly. Connection shall not be made or broken under load. When working on electrical
circuits disconnect the source of power first. Secure temporary wiring so that it is not a trip
hazard. Always assume that circuit sources are alive. Remember that any laboratory source
may be energized at any time. All employees are responsible to be alert to existing hazards
and report them to their supervisor immediately if action required is beyond the scope of
the employee.
Electrical cords used to plug in instruments or mobile laboratories are to be inspected each
time they are plugged in. Mobile lab cords are especially prone to wear and tear as they
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are driven on and used at least twice daily. If the protective coating is pulling away from
the plug head, or there is noticeable darkening of the plug head near the prongs or any
exposed wiring, the cord is to be sent in for repair and a backup cord used until then. For
labs that have hard wired cords, the Lab Director is to be informed immediately.
12.2.3 Engine Exhausts
During field operations and some in-house repair activities, engines may be operated that
exhaust CO and other harmful vapors. It is critical that the chemist or technician be aware
of this potential hazard and take steps to ensure proper ventilation and a safe work
environment.
In the mobile laboratories, CO monitors are used to monitor for any issues with generator
exhausts. The positioning of the lab is critical as the wind may be a culprit is bringing
exhausts into the lab. The use of fans can assist in achieving and maintaining safe levels of
CO inside the lab.
In drilling operations that require the use of the limited access rig, poor ventilation may be
an issue. Steps must be taken to ensure good air flow and that all equipment exhausts are
mitigated.
12.3 Chemical Handling and Storage
12.3.1 Routine Chemical Handling
Special handling instructions, specific hazards and emergency procedures are often written
on chemical containers. These should be reviewed and understood prior to handling the
material. The State of California requires manufacturers and distributors of chemicals to
provide their customers with summaries of the hazardous, toxic and special properties of
these substances. The Company Health and Safety Officer will maintain a file of Material
Safety Data Sheets. The Safety Officer shall be provided with Material Safety Data Sheets
by any individual requesting a new chemical. Chemicals are to be stored in designated
laboratory locations and are to be returned there immediately after use. All secondary
storage containers and solutions shall be clearly labeled as to their contents.
12.3.2 Flammable and Potentially Explosive Substances
Company Management and the Health and Safety Officer prior to commencement shall
review any new operation involving potential fire or explosion risk. Copies of protocols
and experimental procedures are to be provided to the Health and Safety Officer in order
that a proper review can be carried out. Flammable substances are to be stored in
designated cabinets and shall be maintained in the minimum quantities necessary for
laboratory operation.
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12.3.3 Hazardous Material Handling
Individuals handling hazardous materials shall acquire a thorough knowledge of these
materials. Safe handling procedures include, but are not limited to, materials compatibility,
storage properties, transfer procedures, disposal, decontamination procedures and system
design specifications. Prior to initiating work with a potentially hazardous material, the
following precautions shall be taken:
1. The physical and chemical characteristics of the material must be known and
understood,
2. The proper protective materials and clothing must be available,
3. The facility (fume hoods, etc.) must be in proper working order, and
4. The operating procedures must be approved by Management and the Safety Officer.
12.4 Job Safety Analysis
A job safety analysis sheet for Strataprobe, mobile laboratories and hand drilling operations is
required to be on hand and on site by most of H&Ps oil company clients. This document is part of
the QSM and is included.
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13. 0 ANALYTICAL TEST METHODS
LAB ID METHOD CERTIFICATION
FIXED BASE EPA8260B
TPH LUFT
H&P8260SV
EPA TO-15
TPHV
APH (various methods)
FIXED GASES
HELIUM
METHANE
CA ELAP CERT #2741
CA ELAP CERT #2741
DoD CERT #L11-175
LA NELAP CERT 04138/DOD CERT #L11-175
NONE
NONE
NONE
NONE
NONE
LAB 1 (in
process)
H&P8260SV
TPHV BY GCMS
In Process
None
LAB 3 H&P8260SV
TPHV BY GCMS
DoD CERT #L11-175
NONE
LAB 4 H&P8260SV
TPHV BY GCMS
DoD CERT #L11-175
NONE
SB1 H&P8260SV
TPHV BY GCMS
METHANE
FIXED GASES
DoD CERT #L11-175
NONE
NONE
NONE
SB2 EPA8260B
H&P8260SV
TPHV BY GCMS
METHANE
FIXED GASES
CA ELAP CERT #2740/DoD CERT #L11-175
DoD CERT #L11-175
NONE
NONE
NONE
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14.0 ANALYTICAL ISTRUMENTATION
LABORATORY ID
FIXED BASE AUTOSAMPLERS GAS
CHROMATOGRAPHS
DETECTORS
8260 TEKMAR 3000/SOLATEK
72
AG6890 GC#4 SN US00027517 AG5973 MSD SN
UD82311632
8260 ATOMX XYZ AG6850A GC#5 SN US00002576 AG5973 MSD SN
US10441742
TPH DHS LUFT NONE AG5890 GC#6 SN 3235A46654 FID
TO-15 SV & IA ENTECH 7200A, 7032D,
7016D
AG6850 GC#9 SN GC#9
SN6313964
AG 5973N MSD SN
US33246175
TO-15 IA ENTECH 7100AR, 7032 AQ,
7016A
AG6850 GC#12 SN 7324508 AG 5975C MSD SN
US74818075
TO-15 HYBRID ENTECH 7032 A-L, 7016A AG5850 GC#13 SN CN11012006 AG 5975 MSD SN
US11020601
METHANE & FIXED
GASSES
NONE SHUMADZU 14A FID, TCD
HELIUM NONE CARLE 311 TCD
TO-14 NONE SRI ECD, PID, TCD
LAB 1 ATOMX XYZ AG 6890 GC#1 SN US00007247 AG 5973 MSD SN
US72810840
LAB 3
8260 TEKMAR 3000/SOLATEK
72
AG6890 GC#22 SN US00027182 AG 5973 MSD SN
US63810185
LAB4
8260 ATOMX XYZ TEKMAR
3000/SOLATEK 72
AG6850A GC#7 US00002576SN
02-10442379
AG 5973N MSD
US00002451US10442379
SB1
8260 TEKMAR 3000/STRATUM
SOLATEK 72
AG 6890 GC#3 SN US00024631 AG 5973 MSD SN
US72810840
SB2
8260 TEKMAR 3000/SOLATEK
72
AG6890 GC#22 SN US00027182 AG 5973 MSD SN
US63810185
METHANE & FIXED GASES NONE SRI 8610 FID & TCD
OTHER PERIPHERAL
EQUIPMENT
TO-15 Cleaning Oven #1 SN 1203-8185
TO-15 Cleaning Oven #2 SN O-021002-D
TO-15 Cleaning Oven #3 SN B33ER-01731
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15.0 ANALYTICAL SOFTWARE
GCMS Software/Hardware
Model #
Lab MS #OS Chem Station Version MS GC
L3 22 WIN XP 1701DA D.02.00.275 5973 6890 Series Plus +
GPIB PCI Card MS GPIB-20
(Agilent 82350-6511 Rev A)GC GPIB-15
SB2 1 WIN XP 1701DA D.01.02.16 (15-Jun-2004) 5973 6890 Series Plus +
GPIB PCI Card MS GPIB-20
(Agilent 82350-65511 Rev A)GC GPIB-15
SB1 3 WIN XP 1701DA D.01.02.16 (15-Jun-2004) 5973A 6890 Series Plus +
GPIB PCI Card MS GPIB-20
(Agilent 82350-65511 Rev A)GC GPIB-15
CARLSBAD 8260 4 WIN XP 1701DA D.02.00.275 5973 6890 Series Plus +
GPIB PCI Card MS GPIB-20
(Agilent 82350-65511 Rev A)GC GPIB-15
CARLSBAD 8260 5 WIN XP 1701DA D.02.00.275 5973N 6850
IP Address -10.1.1.100 BootP Mac Address -00:60:b0:dd:17:24
Subnet Mask -255.255.255.0 MS IP Address -10.1.1.101
L4 7 WIN XP 1701EA E.02.02.1431 5973N 6850
IP Address -10.1.1.100 BootP Mac Address -00:30:d3:0e:9d:42
Subnet Mask -255.255.255.0 MS IP Address -10.1.1.101
CARLSBAD TO-15 9 WIN XP 1701EA E.02.02.1431 5975C VL 6850N
(Soil Vapor)IP Address -10.1.1.100 Mac Address -00:30:d3:0e:bd:c7
Subnet Mask -255.255.255.0
MS IP Address - 10.1.1.102
GC IP Address –Blank
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15.0 ANALYTICAL SOFTWARE
GCMS Software/Hardware
CARLSBAD TO-15 12 WIN XP 1701EA E.02.02.1431 5975C VL 6850N
(Indoor Air)IP Address -10.1.1.100 Mac Address -00:30:d3:10:67:01
Subnet Mask -255.255.255.0 (Keyboard)MS IP Address -10.1.1.102
GC IP Address -10.1.1.101
CARLSBAD TO-15 13 Win 7 1701EA E.02.02.1431 5975C VL 6850N
IP Address -10.1.1.100 Mac Address -00:30:d3:18:78:81
Subnet Mask -255.255.255.0 (Keyboard)MS IP Address -10.1.1.102
GC IP Address -10.1.1.101
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Appendix B
Standard Operating Procedures
Standard Operating Procedure PFAS 12

PFAS SOP 12 Groundwater Monitoring Well Sampling v0.0.docx
Title: PFAS Groundwater Monitoring Well
Sampling
SOP Number: PFAS SOP 12
Issue Date: October 2019 Approved by: Ken Olson
Prepared by: Dan Schneider Page 1 of 6

1. OBJECTIVE
This SOP describes the equipment, criteria, and procedures that will be used to
sample groundwater monitoring wells. Some deviations from this SOP may be
necessary because of site-specific conditions.
2. BACKGROUND
Per- and Poly-fluoroalkyl substances (PFAS) are synthetic chemicals that have been
used in a variety of consumer and industrial products. They include non-stick
cookware, food packaging, water repellent clothing, stain resistant material and
firefighting foam (AFFF). PFAS chemicals have been found in several types of finished
and raw water supplies and are a concern due to their widespread use, persistent
nature and evidence that continued exposure to certain PFAS chemicals can cause
health issues.
In response to this concern, Method 537.1 was developed and validated by the EPA to
measure 18 PFAS compounds in drinking water. Commercial laboratories have begun using
modified versions to analyze other media including ground water, surface water, wastewater,
landfill leachate and solids. It is important to note that these modifications are not standardized
or validated and could impact result accuracy. The EPA is in the process of establishing
methods specifically for ground water, surface water, wastewater, landfill leachate and solids.
When selecting a laboratory, it is important to evaluate its modified version and verify it will
satisfy project goals. The U.S. Department of Defense Environmental Laboratory
Accreditation Program has a list of requirements pertaining to many of the 537 modified
versions and can be used when choosing a laboratory. Some states have even suggested
using a USDOD certified laboratory as result of this list.
3. EQUIPMENT
Below is a checklist of equipment for conducting groundwater sampling:
a) Tools for opening well covers
b) Keys to wells
c) Water-level indicators
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Standard Operating Procedure PFAS 12

PFAS SOP 12 Groundwater Monitoring Well Sampling v0.0.docx
i. Dual-phase (if free product is suspected)
ii. Single phase
d) Positive displacement pump with silicone tubing
e) pH, conductivity, and temperature meters
f) Standards for pH calibration
g) Chemical resistant gloves
h) Laboratory-supplied sample containers
i) Iced (no chemical ice) cooler
j) Loose leaf paper on aluminum or masonite clipboard
k) Chain of custody form
l) Appropriate personal protection equipment according to PFAS sampling
guidelines
m) Photoionization detector (optional)
n) Drum(s) for purge water containment
o) Drum labels
p) Permanent marker

4. DOCUMENTATION
a) Record project and site information in the field logbook to document site
conditions prior to and during sampling.
b) Prepare chain of custody for submittal with samples to the laboratory.
c) Sample Storage and Submitting
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Standard Operating Procedure PFAS 12

PFAS SOP 12 Groundwater Monitoring Well Sampling v0.0.docx
i. The US EPA provides guidelines for preservation, storage and shipping
for Method 537.1 (drinking water) only. There are no guidelines for
other media.
ii. The use of Trizma preservation is not needed as it is specific to drinking
water only.
iii. EPA time-based studies show ample hold times are 28 days. Samples
should be cooled with ice. Do not use ice packs or bottles (chemical
ice) as they may contain PFAS compounds.
Samples should be shipped overnight per laboratory guidelines. This will ensure
proper holding times and temperature upon receipt.
5. PERSONAL PROTECTIVE EQUIPMENT/SAFETY
a) Identify specific hazards associated with implementation of this SOP and
include discussion and mitigation measures in project Health and Safety Plan
(including discussion of requirement/need for utility clearance for SOP
implementation). Discuss during Pre-task Planning/Kick-off Meetings.
b) Wear and maintain Terracon-approved PPE at project sites and in laboratories
as required by project, task, and/or work environment, except when in a PPE-
Free Zone. This includes use of the Core PPE Kit.
c) Reevaluate risks and necessary actions during initial site mobilization, each
day and when conditions or activities change.
6. PROCEDURES
a) Preliminaries
All equipment will be decontaminated as described in SOP 17 prior to initiating
sampling. Equipment requiring calibration will be calibrated following
manufacturer’s recommendations prior to initiating sampling. If a well pump
will be used, the operating condition of well pump will be checked prior to field
mobilization.
b) Procedures
Upon arriving at each groundwater monitoring well, the well vault cover will be
removed, and the wellhead will be examined. Any signs of tampering will be
recorded in the notes. The lock and well cap will then be removed from the
well casing and depth to water and total depth will be measured.
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Standard Operating Procedure PFAS 12

PFAS SOP 12 Groundwater Monitoring Well Sampling v0.0.docx
c) Well Evacuation
To obtain a groundwater sample representative of natural aquifer conditions,
at least three casing volumes will be evacuated from the well using a positive
displacement pump (that is outfitted with silicon tubing), HDPE disposable
bailer, peristaltic pump with new silicone tubing, or other equipment per the
sampling work plan. Non-disposable equipment will be decontaminated prior
to use as described in SOP 17. Evacuated groundwater will be poured into a
graduated 5-gallon bucket to keep track of the purge volume. If purge water
cannot be discharged at the site, when the graduated bucket is full, the
contents will be transferred into a 55-gallon drum. If the well does not recharge
fast enough to permit the removal of three casing volumes, the well will be
pumped dry and sampled as soon as it has sufficiently recharged.
d) Casing Volume Calculation
The well casing volume will be calculated to determine the purge volume
required to obtain a groundwater sample representative of natural aquifer
conditions. The following procedure will be used to calculate the total purge
volume. Using the top of the north side of the inner well casing as a reference
point, the depth to water (DTW) and total depth (TD) of the well will be
measured using a water-level probe. The height of the water column will then
be calculated by subtracting the depth to water from the total depth of the well
(TD - DTW). Equation (1) below is used to calculate volume constants for wells
with various casing sizes.
Well Casing Volume = π (Casing Radius)2 (7.48 gal/ft3)
where Casing Radius = the radius of the well casing in feet
7.48 gal/ft3 = volume conversion constant
π = constant = 3.14
For a 2-inch diameter well casing:
where Casing Volume = (TD-DTW feet) (0.16 gallons/foot)
Total Purge Volume = Casing Volume x 3
For a 4-inch diameter well casing:
where Casing Volume = (TD-DTW feet) (0.65 gallons/foot)
Total Purge Volume = Casing Volume x 3
e) Stabilization Parameters
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Standard Operating Procedure PFAS 12

PFAS SOP 12 Groundwater Monitoring Well Sampling v0.0.docx
If required by the sampling work plan, groundwater stabilization parameters
pH, temperature, and specific conductivity can be monitored during well
purging to verify when the aquifer has stabilized and groundwater sampling
can commence. Stabilization parameters will be measured at least four times;
once every casing volume and immediately before sampling. All stabilization
parameter measurements will be recorded in the field log book. The following
guidelines are acceptable ranges for stabilization parameters:
• pH readings are consistently within 0.2 pH units;
• temperature is within 0.5˚C of the last reading;
• conductivity is within 10 percent of the last reading.
f) Groundwater Sample Collection
A complete set of laboratory-supplied HDPE sample containers will be
prepared and labeled prior to collecting groundwater samples. A disposable
HDPE bailer or low-flow peristaltic pump with silicone tubing will be used to
obtain groundwater samples. The labels for each groundwater sample will be
double-checked and immediately stored in a cooler filled with Ziploc© (or similar
resealable) baggies full of ice only (no Blue Ice or similar) to maintain a
temperature of 4˚C.
g) Purge Water Containment and Disposal
If required by the sampling work plan, purge water can be contained in labeled
55-gallon drums and stored onsite. At a minimum, drum labels will contain the
following information:
• Site Identification
• Monitoring Well Identification
• Volume (Gallons) of Purge Water
• Terracon
• Terracon Project Manager (Name)
• Office address
The final disposition of the purge water will depend on groundwater analytical
results and contract specifications (disposal options should be determined by
contaminant profile).
h) Decontamination
All sampling equipment will be decontaminated according to SOP 17 before
initiating sampling. If more than one well will be sampled, sampling equipment
must also be decontaminated between wells.
i) Demobilization
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PFAS SOP 12 Groundwater Monitoring Well Sampling v0.0.docx
After well sampling has been completed and all equipment has been
decontaminated, each well will be capped and secured. Damaged equipment
will be noted in the field logbook and labeled on the instrument.
7. REFERENCES
a) Review operating manuals for all equipment used for this SOP.
b) Review local/state specific requirements and modify field practices to conform
to local/state requirements as appropriate.
8. TRAINING
a) Training of new hires and less-experienced staff to be completed by skilled
project staff, PM, APR or SME.
b) Check Terracon University for training modules that may be available.

Draft
SOP 17
Equipment Decontamination
In order to reduce the risk of cross-contamination or transferring contaminants from areas
of known contamination to known clean areas, decontamination of personnel and equipment
is required. The decontamination procedures shall be established for each site based on the
degree of hazard associated with the site and the amount of contact with hazardous
materials resulting from site work. Final decontamination procedures shall be reviewed and
approved by the Site Safety and Health Manager and included in the site-specific Health and
Safety Plan (HASP). This procedure contains general decontamination protocols, suitable for
most sites, although decontamination procedures will be reviewed on a site-by-site,
contaminant-by-contaminant basis. Spent decontamination fluids will generally be
considered non-hazardous waste and disposed accordingly, dependent on contaminant
types present at a given site.
Decontamination Guidelines
Terracon uses a four-step decontamination procedure described below:
Step 1 Gross Contaminant Removal
This step consists of a removing gross materials by gloved hand and then scrubbing
using a detergent solution and water and a stiff brush. Scrubbing will continue until
visible contaminants are removed. The water will be changed as necessary, daily at a
minimum.
Step 2 Alconox Wash
An Alconox wash will be prepared by mixing 1 to 1-½ tablespoons of Alconox per
gallon of warm water. The water will be changed as necessary, daily at a minimum.
Step 3 Clear Water Rinse
A rinse with clear potable water. This water will be changed as necessary to ensure its
purity, daily at a minimum.
Step 4 Distilled Water Rinse
Unused distilled water will be used as a final rinse for all decontamination procedures.
The water may be poured or sprayed.
Decontamination Blanks (Equipment Blanks) to document the decontamination procedures
will be collected if required in the sampling work plan.
Draft
STANDARD OPERATING PROCEDURE E.0025
1
E.0025
BASIC RECORDKEEPING AND FIELD DOCUMENTATION
LAST REVIEW/REVISION: January 2022
OBJECTIVE
To provide a basic level and quality of documentation throughout Terracon projects that
complements and supports other data collection forms in the course of conducting field activities
during environmental assessments, sampling, or remediation. The intent is not to place into
writing an extensively detailed “diary” of every activity, but rather to log and record significant
information that is useful as a measure of field activities during report writing and discussions
with clients and agencies. The information should be legible and readily understood by
someone other than the author; later being used as a reference by managers, other project staff
and quality assurance reviewers. Field records and documentation will be electronically
scanned and placed into the project file and managed in accordance with Terracon’s File
Retention Policies.
PROCEDURES
Appropriate documentation will be maintained to track project activities and document quality
control. The following sections describe the specific records that will be maintained through the
duration of the project.
Individual SOPs, agency- or client-approved sampling plans or other referenced guidance may
prescribe specific additional documentation that staff will complete specific to field tasks. These
forms will be fully completed unless otherwise approved by the Project Manager. Errors in
documents shall be deleted with one line through the erroneous text, and initialed by the author.
At the start and end of the workday on the site, the time shall be noted and each initialed or
signed by the author.
Common and routine field documentation includes, but is not limited to the following;
Safety
Every environmental project should be accompanied by a formal project-specific Health and
Safety Plan (HASP or HSP). The on-site copy of the HSP will be incorporated into field
documentation for on-site use, reference and field notations of required safety measurements
and tailgate safety meetings. Any pre-task planning should be included.
Copies of Work Scope
The on-site copy of the final site-specific Sampling and Analysis Plan will be incorporated into
field documentation for reference and field notations relative to field-dictated changes in sample
Draft
STANDARD OPERATING PROCEDURE E.0025
2
collection, field screening, and laboratory analysis procedures. The field copy of the sampling
plans will include drawings and maps that illustrate property location, property features, and
proposed sampling locations relative to these features. The rationale behind each proposed
location and laboratory analysis will be provided in text and/or tables of the sampling plan for
reference by field staff.
If a formal sampling and analysis plan is not required for the sampling activity or if the plan is
field-derived (i.e., Triad approach), a field copy of the final proposal with scope of work will be
incorporated into field documentation for reference and field notations relative to field-dictated
changes in sample collection.
If a formal Quality Assurance Project Plan (QAPP) is required for the sampling activity, a field
copy of the QAPP will be maintained with field documents for in-progress reference and
discussions with off-site managers/supervisors during the course of field activities.
Field Logbook
Field Site Managers will document activities on daily log forms. The Field Site Manager will
maintain the daily log forms. Between field mobilizations, the Terracon Project Manager or Field
Site Manager will make scanned electronic copies of field documentation for storage in the
project file and will maintain the daily log forms in a project file that will be placed at a central file
location following completion of the project. The daily log forms will include documentation
relative to observed site conditions, sample collection information, problems encountered,
sampling plan deviations, photograph logs, and other relevant information.
Custody Records
Field Site Managers will maintain a copy of completed chain-of-custody records for collected
laboratory samples. The Field Site Manager will provide the Terracon Project Manager copies of
the completed chain-of-custody forms following completion of field activities. The Project
Manager will subsequently maintain these records at the central office file location.
Photographic Documentation
A photographic log will be maintained to document project activities and site conditions.
Photographs will be taken during each day of major field activity. Photographs will be stored
electronically with the project file. Logs will be maintained to document photograph details such
as date, direction, photographer, and photo descriptions.
In taking photographs to document site conditions, field staff should keep in mind the following
general rules;
Draft
STANDARD OPERATING PROCEDURE E.0025
3
· Include objects of scale in the photographs. Preferably items of known dimension in close-
up pictures (e.g., rulers, tape measures, survey rods) and common objects for wider view
documentation of the property (e.g., car, street sign).
· Keep in mind how the documentation will be used and presented in the final report. If
unsure, ask the Project Manager.
· To the extent practical, document the site from a distance and from different directions so
that other users have a perspective of the “total” site.
· Take and document more pictures than you will need for the final report.
Draft

Standard Operating Procedure E.0026

SOP E.0026 Chain of Custody Documentation v0.0
Title: Chain of Custody Documentation SOP Number: SOP E.0026
Issue Date: August 2019
Prepared by: Daniel Schneider
Updated by: Todd McFarland Page 1 of 3
1. OBJECTIVE
This document defines standard operating procedures for documenting sample
collection using proper chain-of-custody techniques. The purpose of proper chain-of-
custody techniques is to provide accountability for and documentation of sample
integrity from the time samples are collected until sample disposal.
This procedure is intended to document sample possession during each stage of a
sample's life cycle, that is, during collection, shipment, storage, and the process of
analysis.
2. BACKGROUND AND REFERENCE
a) Note relevant background information that explains why the procedure is
performed or needed.
b) What types of situations is the procedure used for?
c) What types of situations is the procedure not used for (i.e., similar procedures
or situations that may be confused with the SOP).
3. EQUIPMENT
 Terracon chain-of-custody record(s) or laboratory-specific chain-of-custody forms
(typically supplied with sample containers),
 If samples are being shipped via courier, custody seals for coolers,
 Indelible ink marker, and
 Zip top bag.

4. DOCUMENTATION
a) Note what paperwork needs to be completed and what information should be
documented (e.g., complete chain-of-custody form while sampling).
b) List each form that should be filled out or completed.

Standard Operating Procedure E.0026

SOP E.0026 Chain of Custody Documentation v0.0
5. PERSONAL PROTECTIVE EQUIPMENT
a) Wear and maintain Terracon-approved PPE at project sites and in laboratories
as required by project, task, and/or work environment, except when in a PPE-
Free Zone. This includes use of the Core PPE Kit.
b) Don’t try to account for unusual or special health and safety situations.
Unusual or special health and safety situations should be addressed by the
Health and Safety Plan and the Project Manager.
c) Also note cautions (e.g., “Caution: the 40-milliliter vials contain acid”).
6. PROCEDURES
Sample containers will be labeled in advance of sampling with the sample date,
location (monitor well identifier), sampler’s initials, and project name. Written sample
custody procedures will be followed whenever samples are collected, transferred,
stored, analyzed, or destroyed, to trace possession and handling of a sample from
collection to disposal.
Accountability for a sample begins when the sample is collected. Each sample will be
accounted for with the use of sample labels, chain-of-custody forms, a record of
sample collection, and field data notebooks.
The following chain-of-custody procedures will be implemented by the field staff:
 Entries in the field notebook and chain-of-custody form will be made in ink.
Documentation of each sample must be completed at the time of sampling.
 The chain-of-custody should include at a minimum:
o Project name and/or number
o Name and contact information for the sampler collector
o Collector’s signature
o Sample designation
o Date sampled
o Time sampled
o Sample media
o Number and size of containers for each sample
o Types of sample preservatives used
o Analyses requested
 The original chain-of-custody must accompany the samples at all times after
collection, until relinquished to the analytical laboratory. A copy of the chain-of-
custody form will be kept by the field staff for filing in the project folder at the office.
 The original chain-of-custody form should be sealed in a Ziplock bag if shipping
samples on ice via courier. The sealed Zip top bag will protect the document from
moisture that may be present due to sample preservation. The chain-of-custody
should be the last item packed in a sample cooler, so that it is easily accessible if
the cooler is misplaced by the courier or shipped to an incorrect address.

Standard Operating Procedure E.0026

SOP E.0026 Chain of Custody Documentation v0.0
 If shipping samples, a chain-of-custody specific to the contents of each cooler will
be packaged with the respective samples. Chain-of-custody forms should not be
shipped in separate containers than the samples they document. At least one
custody seal should be completed by the collector and applied to each cooler sent
to the laboratory. The custody seal should be affixed to the cooler in such a
manner as to ensure breakage of the seal upon opening of the cooler (e.g., across
the cooler lid opening).
 When the possession of samples is transferred, the individuals relinquishing and
receiving the samples will sign, date, and note the time on the chain-of-custody
form.
7. REFERENCES
a) Note references (e.g., other SOPs, regulatory standards, etc.) that might aid in
performing the procedure or in selecting between procedures.
8. TRAINING AND CERTIFICATION
 ASTM D4840-99 Standard Guide for Sampling Chain-of-Custody Procedures

Standard Operating Procedure E.0038

SOP E.0038 Soil Excavation Procedures v0.0.docx
Title: Soil Excavation Procedures SOP Number: SOP E.0038
Issue Date: April 2022 Approved by: Ken Olson/Kitty Hiortdahl5
Prepared by: Derek Koller Page 1 of 4

1. OBJECTIVE
General procedures for completing test trenches/test pits during an environmental
investigation.
2. BACKGROUND
Soil excavation has been a common activity during environmental both assessment
and response to address impacts to soil and will continue to be a routine activity
considered to address soil and fill impacts at a broad range of sites. Soil excavation
has the benefit of offering the ability to see a much broader cross-section of native
soil, impacted media and fill, thus expanding the understanding of a site, while allowing
samples to be collected as part of site characterization.
3. EQUIPMENT
a) Personal Protection Equipment (i.e. hardhat, reflective safety vest, impact-
resistant gloves, steel-toe boots, safety glasses, hearing protection)
b) Shovels (flat and spade) and hand-trowel
c) Camera
d) Clipboard
e) Pen – Indelible ink for field notebook, test pit log, and sample labels
f) Field notebook
g) Test pit log
h) Backhoe
i) Power washer
j) Laboratory sampling containers
k) Terracore Samplers if VOC sampling is being conducted
Draft
Standard Operating Procedure E.0038

SOP E.0038 Soil Excavation Procedures v0.0.docx
l) Nitrile Gloves (for environmental sampling)
m) Field screening devices (PID, FID, XRF, etc.)
n) Cooler with ice (for sample storage)
o) Measuring tape
p) Decontamination equipment
q) Robber Gloves (for deconning equipment)
r) Stakes and caution tape if excavations are left open prior to backfilling

4. DOCUMENTATION
a) Complete the necessary documentation of site conditions and field data in
accordance with SOP E.0018 Basic Recordkeeping and Field Documentation
as appropriate. Complete chain of custody in accordance with E.0026 Chain of
Custody Documentation as appropriate.
b) Use Terracon forms or locally generated forms for data collection tabulation
when collected via paper forms or collect electronically when using electronic
forms such as Device Magic.
c) IDENTIFY SPECIFIC FORM AS APPROPRIATE FOR ACTIVITY.
5. PERSONAL PROTECTIVE EQUIPMENT/SAFETY
a) Identify specific hazards associated with implementation of this SOP and
include discussion and mitigation measures in project Health and Safety Plan
(including discussion of requirement/need for utility clearance for SOP
implementation). Discuss during Pre-task Planning/Kick-off Meetings.
b) Wear and maintain Terracon -approved PPE at project sites and in laboratories
as required by project, task, and/or work environment, except when in a PPE-
Free Zone. This includes use of the Core PPE Kit.
c) Reevaluate risks and necessary actions during initial site mobilization, each
day and when conditions or activities change.

Draft
Standard Operating Procedure E.0038

SOP E.0038 Soil Excavation Procedures v0.0.docx
6. PROCEDURES
a) Stake locations of anticipated work areas.
b) Locate all public and private utilities in work area.
c) Upon completion of utility locate begin soil excavation with backhoe. Place
removed soils at a safe distance away from the excavation. Complete all
excavations in accordance with applicable Occupational Safety and Health
Administration (OSHA) standards.
d) Excavate soil at 2-foot intervals to desired depth. Field screen grab samples of
removed soils from backhoe bucket using selected field screening instrument
(at least one sample per 10 cubic yards of soil removed).
e) Prior to collecting soil samples for laboratory analysis, decontaminate backhoe
bucket by scraping loose soils from bucket.
f) Re-advance backhoe bucket to desired sample depth and sampling point and
collect soil into backhoe bucket. Lift bucket to surface for environmental
technician to collect sample from bucket.
g) At completion of sampling, measure width, length, and depth of test pit and
map on Test Pit log.
h) Document soil lithology and presence of apparent non-native materials in field
notebook. Take photographs as warranted. Minimum of one photograph per
test pit for inclusion in digital test pit log.
i) Backfill and test pit and compact soils with backhoe bucket at 2-foot intervals.
Note, if this is not performed immediately, surround test pit with caution tape
until which time this task can be completed.
j) Stake boundaries of test pit or mark boundaries using GPS.
7. REFERENCES
a) Review operating manuals for all equipment used for this SOP.
b) Review local/state specific requirements and modify field practices to conform
to local/state requirements as appropriate.
c) TBD-add any others.
Draft
Standard Operating Procedure E.0038

SOP E.0038 Soil Excavation Procedures v0.0.docx
8. TRAINING
a) Training of new hires and less-experienced staff to be completed by skilled
project staff, PM, APR or SME.
b) Check Terracon University for training modules that may be available.
Draft
Standard Operating Procedure E.100
SOP E.100 Surface and Near-Surface Bulk Sampling v1.01/21/2025 docs
Title: Surface & Near-Surface Bulk Sampling SOP Number:SOP E.100
Issue Date: Sept. 2024 Revision Date (within 3 years): Sept. 2027
Prepared by: Andrew Turner Approved by: SOP Review Committee
Page 1 of 4
1. OBJECTIVE
To provide standard procedure for collecting surface and near-surface soil samples of
unconsolidated materials with hand tools as surface soils, tailings, spoils or other
waste materials appropriate to project conditions.
Samples are generally collected from the surface to a depth of approximately four (~4)
inches. Near-surface soil/tailings/spoils samples are generally collected from the
surface to a depth of approximately four to twelve (~4-12) inches from the original
surface. The original surface may be ground surface or the exposed horizontal or
vertical surface of material excavated in mass from the subsurface.
Grab sampling is appropriate to conditions and projects where the end use of the
sample is not overly sensitive to disturbance and handling during collection. Grab
sampling should not be applied where the sample is used for field or laboratory
measurements of low levels of readily volatile organic compounds. Grab sampling is
appropriate for general field screening and as a field guide to directing environmental
excavation, if compatible with the physical properties of the chemical(s) to be
measured. Grab sampling should not be used for samples intended to represent in-
situ, undisturbed subsurface conditions.
Sufficient samples will be collected for the analysis that will be performed as prescribed
by the project documents. Soil descriptions will be completed for each collected soil
sample using the general terminology of the unified soil classification system (ASTM
D2487-17). Descriptions shall be recorded in field books.
2. BACKGROUND
This SOP is used for surface and near surface soil sampling using hand tools. This
document should be considered supplementary to applicable state/federal SOPs as
Standard Operating Procedure E.100
SOP E.100 Surface and Near-Surface Bulk Sampling v1.01/21/2025 docs
well as Terracon Safe Right Procedures (SRPs). Sampling techniques can vary
between analytical methods and should be reviewed during Pre-Task Planning.
3. EQUIPMENT
 Rigid sampling equipment such as a trowel or shovel of inert material relative to
the chemical(s) of concern and capable of reaching the depths prescribed for
surface and near-surface soils.
 Disposable gloves.
 Nitrile/chemical-resistant gloves and work gloves (cut designation of 3 or greater).
 The laboratory prepared sample containers.
 Roll of plastic sheeting.
 Plastic trash bag for collecting expended supplies.
 Field documentation forms or project logbook.
 Chain-of-Custody forms for samples intended for laboratory analysis.
 Marking pencils or indelible markers that will not leave residues which can cause
interference with laboratory testing procedures.
4. DOCUMENTATION
 Complete the necessary documentation of site conditions and field data in
accordance with SOP E.0018 Basic Recordkeeping and Field Documentation as
appropriate. Complete the chain of custody in accordance with E.0026 Chain of
Custody Documentation as appropriate.
 Use Terracon forms or locally generated forms for data collection tabulation when
collected via paper forms or collect electronically when using electronic forms such
as Device Magic.
 Identify specific form as appropriate for activity.
Standard Operating Procedure E.100
SOP E.100 Surface and Near-Surface Bulk Sampling v1.01/21/2025 docs
5. PERSONAL PROTECTIVE EQUIPMENT/SAFETY
 Identify specific hazards associated with implementation of this SOP and include
discussion and mitigation measures in the project Health and Safety Plan
(including discussion of requirement/need for utility clearance for SOP
implementation). Discuss during Pre-task Planning/Kick-off Meetings.
 Wear and maintain Terracon-approved PPE at project sites and in laboratories as
required by project, task, and/or work environment, except when in a PPE-Free
Zone.
 Reevaluate risks and necessary actions during initial site mobilization, each day
and when conditions or activities change.
6. PROCEDURES
Select the location. Identify it with a unique designation for the project. Diagram, GPS,
or otherwise describe the location on field forms or in the logbook relative to a fixed
benchmark that will allow the specific location to be re-visited in the future, if
necessary. If appropriate, estimate the vertical elevation of the sample and record.
If the grab sample is constructed of multiple aliquots to represent averaging of
conditions in soils/tailings/spoils, diagram, GPS, or otherwise describe the area
represented by the constructed sample. Diagram or otherwise accurately describe
sub-sample locations on forms or in the logbook relative to a fixed benchmark that will
allow the specific sub-sample locations to be re-visited in the future, if necessary. If
appropriate, estimate the vertical elevation of the sub-samples and record.
At each location before collecting the soil sample, put on a clean pair of disposable
chemical-resistant gloves.
Collect each sample by hand using procedures and equipment/tools specified by the
project manager and applicable SOPs.
Place the sample directly into the laboratory prepared sample container(s) and
complete the sample label and Chain-of-Custody as instructed by the project manager.
Standard Operating Procedure E.100
SOP E.100 Surface and Near-Surface Bulk Sampling v1.01/21/2025 docs
If intended for laboratory analysis, preserve the sample as required by project plans.
7. REFERENCES
 Review operating manuals for all equipment used for this SOP.
 Review local/state specific requirements and modify field practices to conform to
local/state requirements as appropriate.
ASTM E1903-19 Standard Guide for Environmental Site Assessments: Phase II
Environmental Site Assessment Process.
8. TRAINING
 Training of new hires and less-experienced staff to be completed by skilled project
staff, PM, APR or SME.
 Check Terracon University for training modules that may be available.
Standard Operating Procedure E.0160
SOP E.0160 Soil Sampling - General v1.0 9-9-24.docx
Title: Soil Sampling - General SOP Number:SOP E.0160
Issue Date: Sept. 2024 Revision Date (within 3 years): Sept. 2027
Prepared by: Andrew Turner Approved by: SOP Review Committee
Page 1 of 5
1. OBJECTIVE
To provide standard procedure for collecting subsurface and near-surface soil
samples appropriate to project conditions.
Sufficient sample will be collected for the analysis that will be performed as prescribed
by the project documents. Soil descriptions will be completed for each collected soil
sample using the general terminology of the unified soil classification system (ASTM
D2487). Descriptions shall be recorded in field books and/or field logs.
2. BACKGROUND
This SOP is used for general surface and subsurface soil sampling using hand tooling
as well as drilling using direct push, sonic, auger, and split barrel techniques. This
document should be considered supplementary to applicable state/federal SOPs, as
well as Terracon Safe Right Procedures (SRPs). Soil sampling techniques can vary
between analytical methods and should be reviewed during Pre-Task Planning.
3. EQUIPMENT
 Surface Soil Sampling Equipment:
o Hand Augers (multiple size
stainless steel buckets)
o Power Auger (if required for
2+ foot depth
o Stainless steel trowels
o Shovels (to remove gravel
and debris
o Plastic sheeting and/or
aluminum foil
o Decontamination equipment
as required
o Hand tools (for equipment or
other needs)
o Camera (Digital or film); or
Cell PhoneWatch
o Field Screening Equipment
(PID, FID, etc.)
o Labels
o Cooler
o Field log book
o Soils Data form, Daily QC
form, etc.
o Site Safety and Health Plan
o Appropriate sample bottles
o Plastic bags (sealable)
o Compass
o Measuring tape or wheel
Standard Operating Procedure E.0160
SOP E.0160 Soil Sampling - General v1.0 9-9-24.docx
 Subsurface Soil Sampling Equipment:
o Drill rig and equipment
o Stainless steel split spoon
o Shelby tubes
o Photoionization detector
o Indelible pens
o Cooler and ice
o Plastic sheeting and/or
aluminum foil
o Measuring tape or measuring
wheel
o Field screening equipment
(PID, FID, etc.)
o Sample containers –
chemical and geotechnical
analysis
o Decontamination equipment
(as necessary)
o Boring log form, etc.
o Ziploc® baggies
o Compass
o Watch
o Camera Phone
4. DOCUMENTATION
 Lithological Logging
The lithology of the sample along with any other pertinent information shall be logged
by an environmental consultant. Particular consideration should be given to grain-size
distribution (relative percentages of different size materials), presence of lamination or
layering and soil consistency. Estimate the mineralogy for coarser grained material.
Classify soil samples and enter onto the boring log using the Unified Soil Classification
System (USCS), following methods outlined in ASTM standard D 2488 (American
Society for Testing and Materials, 1984b). Prepare the final boring log using
observations of the driller and on-site Geologist/Engineer/Environmental Scientist and
from laboratory analysis.
Chain of Custody and other field notes requirements should be documented as
referenced in applicable SOPs.
5. PERSONAL PROTECTIVE EQUIPMENT
 Wear and maintain Terracon-approved PPE at project sites and in laboratories as
required by project, task, and/or work environment, except when in a PPE-Free
Zone.
 Don’t try to account for unusual or special health and safety situations. Unusual
or special health and safety situations should be addressed by the Health and
Safety Plan and the Project Manager.
Standard Operating Procedure E.0160
SOP E.0160 Soil Sampling - General v1.0 9-9-24.docx
 Review SRPs specific to the task to be completed.
6. PROCEDURES
 Surface Soil Procedures
Select the location. Identify it with a unique designation for the project. Diagram, GPS,
or otherwise describe the location on forms or in the logbook relative to a fixed
benchmark that will allow the specific location to be re-visited in the future, if
necessary. If appropriate, estimate the vertical elevation of the sample and record.
Surficial soil samples shall be collected as follows. Vegetation at the sample location
is removed by cutting or scraping away with a stainless-steel trowel. While drilling the
hole, remove gravel or other debris before obtaining the sample. Advance the auger
or trowel to a depth of approximately six inches and then remove from the hole. Using
pre-cleaned stainless-steel equipment, extrude the soil directly into the sampling
containers. If dedicated sampling equipment is not used, sampling equipment must be
decontaminated before collecting another sample. See appropriate SOPs for details
on Sampling Equipment Decontamination.
Samples for VOC analysis must be collected first. Fill VOC sample containers as full
as possible to minimize headspace losses. After mixing as required by project-specific
quality documents, fill separate containers with enough soil for analyses of other
required parameters. Immediately place the samples on ice. Enter all data into field
log book. Describe soil samples as indicated below in Section 3.0, Lithologic Logging.
See appropriate SOPs for details on Sample Preservation, Storage, Handling and
Documentation.
 Subsurface Soil Procedures
Subsurface soil samples can be obtained by several methods depending on the type
of samples required and the soil conditions. The usual method is to collect samples
using a direct push (i.e. Geoprobe), Sonic, or 2.5 to 3-inch diameter, 2.5 to 5 feet long,
continuous-drive, split-barrel sampler, which is advanced with the augers during
drilling. These techniques have several advantages, the primary one being good
sample recovery over a large interval, and accuracy in that cuttings are less likely to
be included in the sample than in other methods. Disturbance to the soil is minimal so
that subtle structures such as laminations or voids are less likely to be destroyed and
geologic contacts are more readily observed and logged. In loose soil and/or where
large debris or cobbles impede the progress of the sampler, sample recovery with a
continuous sampler may be poor and a different sampling technique may be used.
Standard Operating Procedure E.0160
SOP E.0160 Soil Sampling - General v1.0 9-9-24.docx
When continuous drive sampling is not practical, a 24-inch stainless steel split-barrel
sampler can be driven a total of 24 inches into the undisturbed materials by dropping
a 140-lb weight 30 inches. A 3-inch diameter split spoon may be used to increase the
chances of sufficient volume recovery for sampling purposes. Record in 6-inch
increments the number of blows required to drive the sampler, if required. Indicate
these data along with the amount of sample recovery in the drilling log. In the event of
poor sample recovery, the consultant may elect to offset to obtain the missing sample
interval. Note on the boring log if the offset boring is unsuccessful.
At times where samples are required from shallow depths (less than 10 feet) it may be
more feasible to collect samples using a hand auger. In this case a decontaminated
hand auger shall be advanced to the top of the desired sample interval. Continue
through the sample interval and collect the sample using the hand auger or using a
stainless-steel trowel or sampling trier and place in a laboratory-cleaned glass
container and labeled accordingly. Samples for VOC analysis must be collected first
to minimize potential loss of volatiles. To minimize the potential for cross-
contamination, use dedicated stainless-steel trowels or sampling triers at each
location. Between each use, decontaminate sampling equipment in accordance with
appropriate SOPs.
 Sample Collection Procedures
o Field screening samples
Soil samples should be collected for field screening at regular intervals as
specified in the project scoping document, at zones of obvious contamination,
or at the water table. Perform the field screening in accordance with the
applicable SOPs. Note the field screening results on the boring log.
o Laboratory samples
After collecting the field screening samples, collect soil samples for laboratory
analysis. Samples for VOC analysis must be collected first to minimize
potential loss of volatiles. Place VOC soil samples in a suitable container. Fill
sample containers as full as possible to prevent headspace degradation of
VOC. Properly label the container and immediately place the sample into
coolers packed with ice to maintain a temperature of less than 4ºC. When the
headspace screening is complete for each boring, the laboratory sample that
corresponds to the highest headspace sample is selected for laboratory
analysis. If field screening showed no elevated headspace readings, the
sample collected as specified in the project scoping documents.
See appropriate SOPs for details on sample preservation, storage, handling, and
documentation.
Standard Operating Procedure E.0160
SOP E.0160 Soil Sampling - General v1.0 9-9-24.docx
7. REFERENCES
ASTM E1903-19 Standard Guide for Environmental Site Assessments: Phase II
Environmental Site Assessment Process.
ASTM D2487-17 Standard Classification of Soils for Engineering Purposes
(Unified Soil Classification System).
8. TRAINING AND CERTIFICATION
 Training of new hires/less-experienced staff to be completed by skilled project
staff, PM, APR or SME.
 Check Terracon University for training modules that may be available.

Standard Operating Procedure E.0464

SOP E.0464 Sample Handling - Soil (Safety Level D) v0.0.docx
Title: Sample Handling – Soil (Safety Level D) SOP Number: SOP E.0464
Issue Date: April 2022 Revision Date (within 3 years): March 2025
Prepared by: Daniel Schneider Approved by: Ken Olson/Kitty Hortdahl
Page 1 of 4
1. OBJECTIVE
To obtain a representative soil or sediment sample for chemical analysis. This includes
the documentation of sampling methods, and protocols used for sample collection,
processing, handling and shipment.
2. BACKGROUND
Soil and sediment sampling ha ve been a common activity during environmental both
assessment and response to address impacts to soil and will continue to be a routine
activity during site investigation and remediation. Each analyte group often requires
specific sampling protocols, sampling containers, preservation and hold times. The
work plan should include a complete description of the sample locations, depths,
media, purpose and use of sample results, sample container description, preservation
and hold times that will direct actual col lection and analysis to meet the project
objectives.
3. EQUIPMENT
a) Monitoring equipment (PID, FID, multi -gas meters, colormetric detector tubes)
as specified by Project Manager;
b) Sampling Device (split barrel sampler, hand auger, hand trowel, shovel, push
probe sampler, or other appropriate sampling device);
c) Decontamination Equipment;
d) Laboratory prepared sample containers;
e) Forms including soil boring form, chain -of-custody, etc;
f) Indelible ink pen;
g) Stainless steel bowl for composite sampling;
h) Plastic sheeting;
i) Site map;
Draft

Standard Operating Procedure E.0464

SOP E.0464 Sample Handling - Soil (Safety Level D) v0.0.docx
j) Measuring wheel;
k) Engineers tape marked in units of feet, tenths of a foot (0.1 ft.), and hundredths
of a foot (0.01 ft.);
l) Disposable chemical-resistant gloves; and
m) Chem-wipes

4. DOCUMENTATION
a) Complete the necessary documentation of site conditions and field data in
accordance with SOP E.0018 Basic Recordkeeping and Field Documentation
as appropriate. Complete chain of custody in accordance with E.0026 Chain of
Custody Documentation as appropriate.
b) Use Terracon forms or locally generated forms for data collection tabulation
when collected via paper forms or collect electronically when using electronic
forms such as Device Magic.
c) IDENTIFY SPECIFIC FORM AS APPROPRIATE FOR ACTIVITY
5. PERSONAL PROTECTIVE EQUIPMENT
a) Identify specific hazards associated with implementation of this SOP and
include discussion and mitigation measures in project Health and Safety Plan
(including discussion of requirement/need for utility clearance for SOP
implementation). Discuss during Pre-task Planning/Kick-off Meetings.
b) Wear and maintain Terracon-approved PPE at project sites and in laboratories
as required by project, task, and/or work environment, except when in a PPE -
Free Zone. This includes use of the Core PPE Kit.
c) Reevaluate risks and necessary actions during initial site mobilization, each
day and when conditions or activities change .
6. PROCEDURES
a) Surficial soil/sampling
i. Determine sample location (set grid, if necessary)
ii. Determine the proper sampling device based on soil type, depth, sample
type, etc.
iii. Collect each sample at the specified depth consistently for each sample.
Draft

Standard Operating Procedure E.0464

SOP E.0464 Sample Handling - Soil (Safety Level D) v0.0.docx
b) Direct Sampling
i. Transfer sample directly from the sampling device to the sample
container.
ii. If evaluating for organic vapors, transfer the sample to plastic bag (zip
top) for field screening. When appropriate, the sample should be split so
as to obtain a sample for screening that is representative of the sample
for testing. This can be accomplished by slicing the sample (if cohesive)
lengthwise or by using other mechanical means. Care should be taken
so as not to over-agitate the sample, especially if volatile organic
compound testing is required.
iii. Document visual and physical characteristics
c) Composite sampling (non-volatile only)
i. Transfer equal volume/weight of sample from each location/depth to a
stainless-steel mixing bowl
ii. Use a hand trowel or spoon to mix the soil sample
iii. If the sample size is very large, composite on a large sheet of clean plastic or
stainless-steel sheet pan or mix equal volumes from numerous composite
samples.
iv. If soils are cohesive, break up clumps.
v. Spread soil uniformly on plastic sheet or in bottom of stainless-steel bowl or
stainless-steel tray and divide into quarters.
vi. Obtain equal quantity of soil from each sample for transfer to sample
container (without mixing or break up).
d) Decontamination
i. Decontamination procedures should be specified by the project manager.
ii. Decontamination procedures for UST sites includes an Alconoxâ detergent
scrub followed by a clean water rinse.
iii. Decontamination fluids are to be collected and replenished between sample
locations (each boring) to reduce the potential for cross contamination.
e) Sample preservation - store in cooler with ice. Use preservative as appropriate for
the analytes tested.
f) Sample documentation
i. Complete field documentation and chain-of-custody form. Data to be
recorded includes sampling location, methodology, depth, visual and physical
characteristics, time and date.

7. REFERENCES
a) Review operating manuals for all equipment used for this SOP.
b) Review local/state specific requirements and modify field practices to conform
to local/state requirements as appropriate.
c) TBD-add any others.
Draft

Standard Operating Procedure E.0464

SOP E.0464 Sample Handling - Soil (Safety Level D) v0.0.docx
8. TRAINING
a) Training of new hires and less -experienced staff to be completed by skilled
project staff, PM, APR or SME.
b) Check Terracon University for training modules that may be available .

Draft

E.480
SURFACE WATER SAMPLING

Last Review or Revision: June 2010

OBJECTIVE
To collect a representative surface water sample from the sampling point for chemical analysis.
This includes the documentation of sampling methods, sampling supplies, and protocol to reduce
potential for alteration and or cross-contamination during the sampling event.

This TSOP describes the procedure and equipment for collecting surface samples of water or
other liquids using a dipper or equivalent. A pond sampler or dipper with extension handle
allows the operator to sample streams, ponds, waste pits, and lagoons as far as 15 ft from the
bank or other secure footing. The dipper is useful in filling a sample bottle without
contaminating the outside of the bottle. This TSOP can be used to describe the sampling
procedures to be used from a boat or from within the stream using hip-waders, however specific
safety precautions should be implemented in these situations. See the project manager if
sampling will not be conducted from the shore or other stable surface (boat dock, etc.).

EQUIPMENT
 Sampling and monitoring equipment specified by project
manager;
 Disposable chemical-resistant gloves;
 Cleaning equipment;
 Proper forms, labels and indelible ink pen;
 Sample containers and packing material, tape, and labels;
 Cooler with ice pack and packing media;
 Dipper or equivalent sampling device; and
 Site map.

PROCEDURES

1. Clean sampling equipment in accordance with SOP 17.
2. Locate sampling site at the designated point in the stream.
3. Attach extensions to the dipper as required to reach the distance from the shore specified by
the project manager.
Draft
TSOP E.480 Terracon

2
4. Submerge the container end of the dipper at sampling point such that mouth of dipper is at
the depth specified by the project manager. If no depth has been specified, submerge the
dipper about 2 to 3 inches below the water surface, if possible.
5. Allow the dipper to fill; rinse the dipper by shaking and discharging this water. Repeat this
procedure three times.
6. Collect sample and transfer into a holding container or directly to the laboratory sample
container. If a holding container is used for ease of transfer or to create a composite sample
from multiple sampling locations, transfer water from the holding container into sampling
bottles.
7. Fill out appropriate field form(s) documenting sample location, time, and other pertinent
information before leaving sampling site.

OTHER SUPPORTING DOCUMENTS
ASTM D5358-93 Standard Practice for Sampling with a Dipper or Pond Sampler.
Draft
Standard Operating Procedure E.0495
PFAS SOP E.0495 Surface Water Sampling v0.0 - Approved.docx
Title: Perfluoroalkyl and Polyfluoroalkyl
Substances (PFAS) Surface Water Sampling
SOP Number:SOP E.0495
Issue Date: October 2019 Approved by: Ken Olson
Prepared by: Dan Schneider Page 1 of 6
1. OBJECTIVE
The purpose of this standard operating procedure (SOP) is to help provide uniform
sampling techniques when collecting surface water samples for selected PFAS analyses.
These guidelines should help ensure that samples are collected in a manner which
allows for accurate data collection by limiting the potential risks of cross-contamination
from a variety of sources including but not limited to sampling equipment, sampling
techniques and personal protective wear.
2. BACKGROUND AND REFERENCE
Per- and Poly-fluoroalkyl substances (PFAS) are synthetic chemicals that have been
used in a variety of consumer and industrial products. They include non-stick
cookware, food packaging, water repellent clothing, stain resistant material and
firefighting foam (AFFF). PFAS chemicals have been found in several types of finished
and raw water supplies and are a concern due to their widespread use, persistent
nature and evidence that continued exposure to certain PFAS chemicals can cause
health issues.
In response to this concern, Method 537.1 was developed and validated by the EPA
to measure 18 PFAS compounds in drinking water. Commercial laboratories have
begun using modified versions to analyze other media including ground water, surface
water, wastewater, landfill leachate and solids. It is important to note that these
modifications are not standardized or validated and could impact result accuracy. The
EPA is in the process of establishing methods specifically for ground water, surface
water, wastewater, landfill leachate and solids. When selecting a laboratory, it is
important to evaluate its modified version and verify it will satisfy project goals. The
U.S. Department of Defense Environmental Laboratory Accreditation Program has a
list of requirements pertaining to many of the 537 modified versions and can be used
when choosing a laboratory. Some states have even suggested using a USDOD
certified laboratory as result of this list.
3. EQUIPMENT
a)Avoid using any material or equipment that has or may have fluoropolymers
(Teflon, Polytetrafluoroethylene (PTFE), Ethylene tetrafluoroethylene (ETFE),
Fluorinated ethylene propylene (FEP)) as they could result in sample
contamination.
Standard Operating Procedure E.0495
PFAS SOP E.0495 Surface Water Sampling v0.0 - Approved.docx
b)Low Density Polyethylene (LDPE) can be used if it does not come in contact
with the sample media.
c)If possible, use High Density Polyethylene (HDPE), polyvinyl chloride (PVC) or
silicon single use disposable materials.
d)Dedicate non-disposable materials to the project to reduce the potential for
cross-contamination from other projects.
e)Use nylon or cotton string/rope when using bailors, buckets, etc.
f)Keep sampling equipment in factory packaging until needed.
g)If possible, have the equipment manufacturer provide a confirmation letter or
certificate that the equipment/material is PFAS free. Equipment and field
blanks using certified PFAS free water (available from the analytical laboratory)
should be collected in the event a certificate from the manufacturer cannot be
obtained.
h)Horizontal and vertical (Van Dorn) style samplers may have components that
contain PFAS chemicals but can be used if found PFAS free.
i)Automated samplers should be equipped with silicon pump tubing and HDPE
or polypropylene sample line and bottles if possible. Unlined HDPE or
polypropylene bottle caps should also be used. LDPE is acceptable if it is
shown to be PFAS free.
j)Do not filter samples. Filtering could produce an artificially low result because
some PFAS chemicals are not hydrophilic and can be loss in the process
k)Use HDPE sample bottles provided by the laboratory.
l)Pencils, ball point pens and plain white paper should be used when recording
field notes. Do not use markers, plastic clip boards or water-resistant paper.
4. DOCUMENTATION
a)Record project and site information in the field logbook to document site
conditions prior to and during sampling.
b)Prepare chain of custody for submittal with samples to the laboratory.
c)Sample Storage and Submitting
Standard Operating Procedure E.0495
PFAS SOP E.0495 Surface Water Sampling v0.0 - Approved.docx
i.The US EPA provides guidelines for preservation, storage and shipping
for Method 537.1 (drinking water) only. There are no guidelines for
other media.
ii.The use of Trizma preservation is not needed as it is specific to drinking
water only.
iii.EPA time-based studies show ample hold times are 28 days. Samples
should be cooled with ice. Do not use ice packs or bottles (chemical
ice) as they may contain PFAS compounds.
d)Samples should be shipped overnight per laboratory guidelines. This will
ensure proper holding times and temperature upon receipt.
5. PERSONAL PROTECTIVE EQUIPMENT/SAFETY
a)Identify specific hazards associated with implementation of this SOP and
include discussion and mitigation measures in project Health and Safety Plan
(including discussion of requirement/need for utility clearance for SOP
implementation). Discuss during Pre-task Planning/Kick-off Meetings.
b)Wear and maintain Terracon-approved PPE at project sites and in laboratories
as required by project, task, and/or work environment, except when in a PPE-
Free Zone. This includes use of the Core PPE Kit.
c)Reevaluate risks and necessary actions during initial site mobilization, each
day and when conditions or activities change.
d)Personal Clothing
i.PFAS chemicals are commonly used to produce water proof/resistant,
stain resistant and insulating material (Gore-Tex). These types of
clothes should be avoided if possible.
ii.Use clothing that is made with synthetic and natural fibers (cotton) that
has been washed a minimum of 5 times (not brand new). Fabric
softeners can also contain PFAS chemicals. Do not wash clothes with
softener prior to wearing the clothing for sampling.
e)Personal Protective Equipment (PPE)
i.PFAS chemicals are also used in certain articles of PPE. These include
coated Tyvek suits, water resistant footwear and disposable gloves.
Standard Operating Procedure E.0495
PFAS SOP E.0495 Surface Water Sampling v0.0 - Approved.docx
ii.Personal Safety is the Number One Priority When Sampling. At no point
will PPE be disregarded to eliminate potential impacts to the sample
media. If available, a suitable PFAS free PPE alternative or sampling
method will be used. For example, PFAS free boot covers can be used
in combination of safety toed boots. Non-coated Tyvek suits are also
acceptable. PFAS containing PPE shall be used in the event an
alternative is not found. The use of such material should be recorded in
the field notes.
iii.Do not use latex gloves. Instead, use powder free Nitrile gloves.
iv.Many brands of insect repellant and sun screen have also been found
to contain PFAS chemicals. Eliminate using such PFAS-containing
materials. Contact the manufacturer to confirm a product is PFAS free
if it is unknown. At a minimum, apply the product away from the
sampling area.
f)Personal Care Products
i.Personal care products have also been found to contain PFAS
compounds. Examples include makeup, moisturizer, dental floss. It is
recommended to limit/eliminate the use of personal care products the
day of sampling. At a minimum, they should be applied away from the
immediate sampling area.
6. PROCEDURES
Several issues need to be taken into consideration when sampling surface water for
PFAS chemicals. Its widespread use produces great potential for cross-contamination.
In addition, not all PFAS chemicals are hydrophilic in nature and can stratify, adhere
and or absorb to material. This can potentially generate an artificially low result. The
guiding principle when sampling is limiting the use of any material or condition that
could potentially alter a sample result. When in doubt err on the side of caution.
Standard Operating Procedure E.0495
PFAS SOP E.0495 Surface Water Sampling v0.0 - Approved.docx
a)Decontamination
i.As stated earlier, the use of single use disposable materials is
preferred.
ii.Decontamination of non-disposable equipment should be done prior to
use, in between samples and before storage.
iii.Laboratory certified PFAS-free water is preferred. Commercial
deionized water or city water may be used if it is verified PFAS free.
Available water can also be tested for PFAS to verify
absence/presence.
iv.Several soaps have been found to be PFAS free. They include Alconox,
and Liquinox. Do not use Decon 90.
v.Cleaning equipment should also be PFAS free. For example, use PVC
bristled scrub brushes.
vi.Periodically collect field rinsate samples using laboratory provided
PFAS free water or other water that has been shown to be PFAS free.
b)Sample Storage and Submitting
i.The US EPA provides guidelines for preservation, storage and shipping
for Method 537.1 (drinking water) only. There are no guidelines for
other media.
ii.The use of Trizma preservation is not needed as it is specific to drinking
water only.
iii.EPA time-based studies show ample hold times are 28 days. Samples
should be cooled with ice. Do not use ice packs or bottles (chemical
ice) as they may contain PFAS compounds.
iv.Samples should be shipped overnight per laboratory guidelines. This
will ensure proper holding times and temperature upon receipt.
Standard Operating Procedure E.0495
PFAS SOP E.0495 Surface Water Sampling v0.0 - Approved.docx
7. REFERENCES
a)Review operating manuals for all equipment used for this SOP.
b)Review local/state specific requirements and modify field practices to conform
to local/state requirements as appropriate.
8. TRAINING AND CERTIFICATION
a)Training of new hires and less-experienced staff to be completed by skilled
project staff, PM, APR or SME.
b)Check Terracon University for training modules that may be available.
Standard Operating Procedure E.0552
SOP E.0552 Field Headspace Screening - Soil - Photoionization Detector v0.0.9-9-2024.docx
Title: Field Headspace Screening – Soil /
Photoionization Detector
SOP Number:SOP E.0552
Issue Date: Sept. 2024 Revision Date (within 3 years): Sept. 2027
Prepared by: Chris Bartley Approved by: SOP Review Committee
Page 1 of 4
1. OBJECTIVE
To provide a qualitative and limited quantitative field screening of soil samples to aid in
the evaluation of soil for the presence of volatile or semi-volatile organic chemicals.
2. BACKGROUND
The procedure is premised on the physical property of volatile compounds to move from
the soil matrix of a freshly obtained soil sample (e.g., split spoon sample, grab sample,
etc.) to the airborne state as vapor. The measurement of ambient air in close proximity
to the surface of the soil or drilling core will produce an indication of contaminants moving
from the soil matrix to air. The relative strength of contaminants in ambient air around
the sample will be considered an indication of the relative concentration of chemicals in
the soil sample.Note that often, a sample aliquot may be maintained in a separate
container, free from headspace, and store in an iced cooler for later fixed-
laboratory analysis. Please refer to associated proposal/quality documents for the
project.
The procedure is semi-quantitative and valid only for the most preliminary qualitative
decision-making. The procedure is highly susceptible to external air changes in wind
velocity, ambient dilution by moving air and ambient influence by contaminants in moving
air. The rate and degree of volatilization is susceptible to smearing of the exterior of the
sample by the sampler wall in clay soils.
Measurements cannot be used as the sole indicator of soil contamination or in lieu of
prescribed laboratory chemical testing for purposes of regulatory compliance. This
procedure is only to be used for sites involving volatile or semi-volatile organic
compounds. This procedure is not to be used for purposes of health and safety
monitoring.
Standard Operating Procedure E.0552
SOP E.0552 Field Headspace Screening - Soil - Photoionization Detector v0.0.9-9-2024.docx
3. EQUIPMENT
 Calibration gas from manufacturer
 Photoionization detector (PID) equipped with 10.0 eV lamp or greater (depending on the
contaminants to be screened)
 Forms and indelible ink pen
 Disposable chemical-resistant gloves
 Test chamber, reusable or disposable, examples:
 Mason jar with aluminum foil
 Mason jar equipped with charcoal filter
 Ziploc bags or other sealable containers of at least 500 cubic centimeters to provide
a fixed headspace volume for constancy between tests
 Rigid, disposable concrete test cylinder mold with plastic cap
4. DOCUMENTATION
Record the highest reading in calibration gas equivalents on forms provided by the
Project Manager or in the field logbook. Pertinent data will vary based on the parameter
and the form; however, the following data must be recorded; date, job number, project
name, sampling location, sample interval (if appropriate) sample identification, samplers
name, and general observations.
5. PERSONAL PROTECTIVE EQUIPMENT
 Wear and maintain Terracon-approved PPE at project sites and in laboratories as
required by project, task, and/or work environment, except when in a PPE-Free
Zone.
 Don’t try to account for unusual or special health and safety situations. Unusual
or special health and safety situations should be addressed by the Health and
Safety Plan and the Project Manager.
 Follow manufacturer’s safety recommendations for the specific instrument you are
using.
Standard Operating Procedure E.0552
SOP E.0552 Field Headspace Screening - Soil - Photoionization Detector v0.0.9-9-2024.docx
6. PROCEDURES
Immediately prior to making a field measurement, the PID should be operated for
approximately 1 minute and any background concentrations noted or ”zero-ed out”
relative to measurements.
Daily, the unit should be gas calibrated to a manufacturer’s gas standard and the results
recorded in the field logbook. If the unit does not calibrate, return it to the local Terracon
equipment evaluation for evaluation and, if necessary, repair.
Prior to site testing an empty, unused test chamber should be sealed containing nothing
but ambient air and allowed to stabilize for 1 minute. Test the chamber headspace to
identify background contaminants contributed by the chamber itself. If anything is
detected, change to another type of chamber which is inert relative to contributing
ionizable materials to the headspace.
 Transfer soil sample representative of the condition to be measured from the
sampling device to testing chamber (e.g., mason jar covered by aluminum foil,
disposal concrete cylinder mold, Ziplock bag, or other sealable container).
 Sample material should be representative of the vertical and horizontal cross-section
of the sampled interval.
 The volume of soil should remain as constant as is practical for all site tests.
 The soil volume should not exceed 25% of the total volume of the air-filled testing
chamber.
 Immediately seal the chamber after transfer and allow the sample to equilibrate for a
minimum of 15 minutes at ambient temperatures above 50 F.
Standard Operating Procedure E.0552
SOP E.0552 Field Headspace Screening - Soil - Photoionization Detector v0.0.9-9-2024.docx
 Insert probe into sealed container for reading for 1 minute for volatile compounds of
concern and 3 minutes for semi-volatile compounds of concern to account for varied
response times.
Record highest reading obtained as parts per million (ppm) calibration gas equivalents
(i.e., TEI580 calibrated to isobutylene would be expressed as ppmi).
Sample Disposal
Soil Samples should be returned to the site and included in auger soil or excavation soil
for proper disposal.
7. REFERENCES
Operating/User’s Manual for the Equipment Being Used
8. TRAINING AND CERTIFICATION
 Follow manufacturer’s instructions for use in the User’s Manual as well as any
online instructional resources.
Standard Operating Procedure E.1940
SOP E.1940 Groundwater Sampling – Low Flow Groundwater Sampling v1.0 1/21/2025
Title: Groundwater Sampling – Low Flow
Groundwater Sampling
SOP Number:SOP E.1940
Issue Date: Sept. 2024 Revision Date (within 3 years): Sept. 2027
Prepared by: Andrew Turner Approved by: SOP Review Committee
Page 1 of 4
1. OBJECTIVE
To collect a representative groundwater sample from the sampling point for chemical
analysis. This procedure should be used when attempting to minimize stress to the
aquifer due to monitoring well sampling. This procedure includes the documentation
of sampling methods, supplies and protocols to reduce potential for inaccurate
representative samples and or cross-contamination during the sampling event.
2. BACKGROUND
This SOP is used for low-flow volumetric or parametric purging/sampling. This
document should be considered supplementary to applicable state/federal SOPs as
well as Terracon Safe Right Procedures (SRPs). Sampling techniques can vary
between analytical methods and should be reviewed during Pre-Task Planning.
3. EQUIPMENT
 Groundwater Elevation Data form.
 laboratory Chain-of-Custody form.
 laboratory sample labels.
 field logbook.
 indelible ink pen.
 pH, temperature, and specific conductance meter.
 turbidity meter.
 sample containers and packing material.
 cooler with ice pack and packing media.
 well purging equipment – disposable bailers and string.
 sampling device – low-flow peristaltic pump.
 mobile, secure shed to protect equipment during sampling (insulated during colder
weather).
Draft
Standard Operating Procedure E.1940
SOP E.1940 Groundwater Sampling – Low Flow Groundwater Sampling v1.0 1/21/2025
 keys for locking cap on well and secure shed.
 Deionized (DI) water
 site map
4. DOCUMENTATION
a.) Record all pertinent sampling information on the sampling container label, sampling
information form, chain-of-custody, and shipping form.
 Pertinent data will vary based on the parameters and the form; however, the
following data must be recorded - time, date, job number, project name, sampling
location, samplers name, sampling methodology, parameters to be analyzed,
stabilization data, and general observations.
 Make appropriate entries in the chain-of-custody form at time of sample collection
- ensure that the chain-of-custody protocol required for the project is maintained
5. PERSONAL PROTECTIVE EQUIPMENT
a)Wear and maintain Terracon-approved PPE at project sites and in laboratories
as required by project, task, and/or work environment, except when in a PPE-
Free Zone.
b)Don’t try to account for unusual or special health and safety situations.
Unusual or special health and safety situations should be addressed by the
Health and Safety Plan and the Project Manager.
c)Reevaluate risks and necessary actions during initial site mobilization each day
and when conditions or activities change.
6. PROCEDURES
Preparation
 Obtain the sample containers, forms, and equipment necessary to complete the
sampling event;
 Calibrate all field equipment i.e., temperature, pH, specific conductance meter and
turbidity meter;
 Document equipment calibration in field logbook; and
 Establish sampling sequence.
Draft
Standard Operating Procedure E.1940
SOP E.1940 Groundwater Sampling – Low Flow Groundwater Sampling v1.0 1/21/2025
Monitoring Well Purging (when needed)
 Document all field activities in field logbook and field forms
 Water levels - collect and record water levels
 Purge monitoring wells
o Using low-flow sampling equipment or bailers, remove three (3) well casing
volumes of water from each well (or until well goes dry)
o Collect purge water in a bucket and dispose of in accordance with
investigatory derived waste (IDW) handling procedures for the site
 Return to site after stabilization
 Contamination minimization
o Use plastic sheet as an apron to isolate the wellhead by splitting sufficiently
to pass the well protector and slide over wellhead onto ground.
Sampling
 Use a low-flow sampling pump
 Determine proper depth of purging device, approximately half the distance of the
water column or approximate middle of the well screen
 Attach new section of pump tubing to pump
 Lower pump suction tubing slowly (to minimize disturbance) into well to midpoint
of sampling zone
 Start pump at its lowest setting and slowly increase speed until discharge occurs.
 Check water level and adjust pump speed to maintain drawdown at less than four
(4) inches and pump no faster than 0.2 L/min
 Stabilization parameters
o Record turbidity, temperature, pH, and specific conductance at regular
intervals
o Pump until measured parameters are stabilized
 Transfer the groundwater sample directly to the laboratory prepared sample
containers
 Fill sample containers by allowing pump discharge to flow gently down the side of
the container with minimal disturbance
 Do not over-fill sample containers which contain a preservative
 Place samples in cooler with ice
7. REFERENCES
Low Stress (Low Flow) Purging and Sampling Procedure for the Collection of Ground
Water Samples from Monitoring Wells, EPA Region 1, July 30, 1996, Revision 2.
Draft
Standard Operating Procedure E.1940
SOP E.1940 Groundwater Sampling – Low Flow Groundwater Sampling v1.0 1/21/2025
8. TRAINING AND CERTIFICATION
a)Training is available both internally and externally (refer to Terracon
University).
Draft
Standard Operating Procedure E.2128
SOP E.2128 Sub-slab and Surface Vapor Sampling v.1.0 9-9-24.docx
Title: Standard Operating Procedures for Sub-
slab & Shallow Soil Vapor Sampling
SOP Number:SOP E.2128
Issue Date: Sept. 2024 Revision Date: Sept. 2027
Prepared by: Andrew Turner Approved by: SOP Review Committee
Page 1 of 9
1. OBJECTIVE
General procedure for collecting representative sub-slab & shallow soil vapor
samples during an environmental investigation.
The purpose of this SOP is to provide general guidance and recommended standard
practices for conducting sub-slab vapor sampling.
2. BACKGROUND AND REFERENCE
This SOP is used for both sub-slab and surface vapor sampling. This document
should be considered supplementary to applicable state/federal SOPs as well as
Terracon Safe Right Procedures (SRPs). Sampling techniques can vary between
analytical methods and should be reviewed during Pre-Task Planning.
3. EQUIPMENT
 Level D PPE.
 Rotary Hammer Drill.
 1/2-inch diameter hammer bit.
 1 1/2-inch diameter hammer bit and flush mount cover (for flush mount
applications).
 Wet/dry vacuum equipped with HEPA filtration unit.
 Power source, if needed for drill or vacuum.
 Bottle brush.
Standard Operating Procedure E.2128
SOP E.2128 Sub-slab and Surface Vapor Sampling v.1.0 9-9-24.docx
 Vapor Pin®, new silicone sleeve, and protective cap (or stainless steel, Teflon, or
other inert 1/4-inch tubing and grout, cement or other non-VOC containing and
non-shrinking product to construct vapor sampling point and seal).
 Vapor Pin® installation/extraction tool.
 Mallet or drive hammer, if using Vapor Pin® system.
 1 1/2 to 2-inch (height) piece of 2 1/2-inch diameter (or greater) PVC pipe and
modeling clay (or similar – must be non-VOC containing), if using water dam for
leak testing*.
 Distilled water, if using water dam for leak testing*.
 Concrete patching compound.
 Putty knife.
 New inert sample tubing [¼-inch outside diameter (OD)] to connect to sampling
canister: Teflon, Teflon-lined, Nyalflow or similar. The use of polyethylene tubing
is commonly used for groundwater sampling or vinyl tubing.
 Laboratory-provided vacuum sampling canister with vacuum gauge and flow
regulator (e.g., 200 milliliters per minute).
 1/4-inch Swagelock nut.
 1/4-inch Ferrule.
 1/4-inch Spacer nut.
 Moisture filter.
 3/8-inch OD inert tubing to construct sampling train.
 Fittings/valves (to be used with 3/8-inch OD inert tubing): Stainless steel or plastic
ball or 3-way valves, tee connectors and/or couplers. Setting up will vary based on
Standard Operating Procedure E.2128
SOP E.2128 Sub-slab and Surface Vapor Sampling v.1.0 9-9-24.docx
user preference and sampling train. Connections between tubing and fittings
should be airtight. Fittings and valves should be properly decontaminated between
sampling locations. Brass is not recommended, because of the potential for
residual cutting oils to be present.
 Graduated syringe, peristaltic pump, or similar for purging.
 Vacuum gauge and pump or hand pump with gauge, if conducting vacuum shut-in
testing on sampling train*.
 Shroud, tracer gas (e.g., helium) and portable tracer gas detector, if conducting
tracer gas leak testing*.
 Field screening devices (PID, FID, etc.).
 Field Notebook/Soil Vapor Field Data Form.
 Chain of Custody.
 Decontamination supplies.
It is recommended that some form of leak detection be used during sub-slab vapor
sampling events. The degree of the leak testing will depend on the project objectives.
Vacuum shutting in testing is used to detect leaks in the connections in the sampling
train, while both a water dam and tracer gas leak testing is used to detect potential
short circuiting between the sub-slab and ambient air. Therefore, choosing either a
water dam or trace gas leak testing rather than conducting both is generally
appropriate.
4. DOCUMENTATION
Field Data Form: Sub-Slab Soil Gas Sampling (attached)
5. PERSONAL PROTECTIVE EQUIPMENT
Standard Operating Procedure E.2128
SOP E.2128 Sub-slab and Surface Vapor Sampling v.1.0 9-9-24.docx
 Identify specific hazards associated with implementation of this SOP and include
discussion and mitigation measures in the project Health and Safety Plan
(including discussion of requirement/need for utility clearance for SOP
implementation). Discuss during Pre-task Planning/Kick-off Meetings.
 Wear and maintain Terracon-approved PPE at project sites and in laboratories as
required by project, task, and/or work environment, except when in a PPE-Free
Zone.
 Reevaluate risks and necessary actions during initial site mobilization, each day
and when conditions or activities change.
6. PROCEDURES
 Locate public and private utilities in the work area. Scanning the sampling location
with ground penetrating radar (GPR) may be required.
 Put on appropriate PPE.
 If installing a permanent flush mount vapor sampling point, drill a 1 1/2-inch
diameter hole at least 1 3/4 inch into the floor slab.
 Drill a 5/8-inch diameter hole through the floor slab (and in the middle of the 1 1/2-
inch diameter hole, if installing a permanent sampling point) and about 1 to 2
inches into the underlying soil.
 Brush the hole with the bottle brush to remove concrete cuttings. Use a vacuum
equipped with HEPA filter to remove loose cuttings and soil, if required.
 For Vapor Pin® installation, place the lower end of the Vapor Pin® with silicone
sleeve in 5/8-inch hole and place the small hole located in the handle of the
installation/extraction tool. Tap Vapor Pin® into place using mallet. Make sure
installation/extraction tool is parallel to Vapor Pin® to avoid damaging barbs on
Vapor Pin®. Silicone sleeve should bulge slightly between floor slab and Vapor
Pin® shoulder. Place protective cap on Vapor Pin®.
Standard Operating Procedure E.2128
SOP E.2128 Sub-slab and Surface Vapor Sampling v.1.0 9-9-24.docx
 If constructing a vapor sampling point, cut the length of inert, 1/4-inch tubing long
enough to extend through the slab into the open cavity below the slab. To avoid
obstruction of the tubing, ensure that it does not extend into the sub-slab soil. Add
coarse sand or glass beads to cover the tip of the tubing. Establish a seal between
the tubing and top of the floor slab using grout, cement or other non-VOC
containing and no-shrinking product. Cap the end of the tubing. Sampling should
not occur until after the seal has properly set.
 Allow at least 20 minutes (or as required by oversight agency) for sub-slab
conditions to equilibrate prior to sampling.
To construct a water dam, which tests for short-circuiting leaks between sub-slab
and ambient air, begin by placing PVC ring around vapor point. Secure PVC ring
to floor surface using a bead of non-volatile molding clay. If a flush mount vapor
point is being constructed, use of the PVC ring is not needed, and water can be
placed within the 1 1/2-inch drilled hole.
 Remove the protective cap and attach 3/8-inch OD tubing to vapor sampling point.
Attach fittings/valves and tee connections so a continuous connection can be
maintained and isolated between the sampling point and the sampling canister and
between the sampling point and an auxiliary connection onto which a PID, syringe,
or pump can be connected. The use of fittings and tee connections in the sampling
train allow the user to switch flow between tubing leading to the sampling canister
and tubing leading to the syringe, pump, PID, etc. without introducing ambient air.
A typical sampling train will include tubing with a tee connection between the vapor
point and sampling canister. The second, auxiliary connection from the tee will
have a valve downstream of the tee.If conducting a shut-in test, a valve should
be installed between the vapor point and sampling canister so that the sampling
train can be pressurized without drawing air through the Vapor Pin®.If
conducting a helium test, the tubing between the vapor point and sampling
canister should be placed through the shroud (e.g., plastic storage bin) – see
example below.
Standard Operating Procedure E.2128
SOP E.2128 Sub-slab and Surface Vapor Sampling v.1.0 9-9-24.docx
Examples of Sampling Trains:
 Connect sampling canister to sampling train using laboratory instructions, which
generally involve removal of the brass cap from the top of the canister. Connect
about 6 inches of 1/4-inch Teflon or similar tubing to top of sampling canister. Place
ferrule on 1/4-inch Teflon tubing, followed by spacer nut and Swagelock nut. Hand-
tighten nut to top of canister and then lightly tighten using a 9/16-inch wrench. Do
Standard Operating Procedure E.2128
SOP E.2128 Sub-slab and Surface Vapor Sampling v.1.0 9-9-24.docx
not overtighten. Lightly tug on tubing to confirm connection has been made.
Connect moisture filter to end of Teflon tubing and connect to 3/8-inch OD tubing
on sampling train. Do not open the valve on the sampling canister until leak testing
and purging has occurred.
If using a water dam, pour distilled water into PVC ring taking care not to
submerge the top of the vapor point. If a flush mount vapor point is being
constructed, use of the PVC ring is not needed and water can be placed within the
1 1/2-inch drilled hole. During purging and sampling, the water level in the dam will
be monitored. If water is lost, the Vapor Pin® will be reinstalled, or the seal
otherwise re-established and sampling procedure will be repeated.
To conduct a vacuum shut-in test, which tests for leaks in the sampling train,
close the valve between vapor sampling point and the sampling canister. Attach a
vacuum gauge and purge pump or hand pump with gauge to auxiliary line. Open
valve downstream of tee connection, between pump and sampling canister.
Pressurize line to demonstrate vacuum. Turn off pump. Monitor gauge for 2 to 3
minutes to ensure pressure in sampling train remains consistent. If pressure is lost,
fittings should be checked and re-established before conducting shut-in test again.
Close valve on auxiliary line.
To conduct a helium tracer test,which tests for short-circuiting leaks between
sub slab and ambient air, introduce helium gas into the shroud. Measure helium
concentration in shroud with portable gas meter. Helium concentration should be
between 15 to 20 percent (%) by volume.
 Open valve on auxiliary line and purge at least two volumes of “dead air” from the
sampling train and vapor point using a graduated syringe, pump, or similar. The
purging should be conducted at a low-flow rate (i.e., less than 200 ml/min). Close
valve on auxiliary line.
If conducting a helium tracer test, connect portable tracer gas detector to
auxiliary line and open valve. If the detected tracer gas concentration is 5% or
Standard Operating Procedure E.2128
SOP E.2128 Sub-slab and Surface Vapor Sampling v.1.0 9-9-24.docx
more of helium concentration within the shroud, the sampling point and sampling
train should be examined for potential leaks and the tracer test reconducted.
 To begin sampling, ensure valve on auxiliary tubing is closed. Open valve on
sampling canister and record canister vacuum. If canister is not under full vacuum,
do not use canister for sample collection. Record time sample collection began.
 Close sampling canister valve when the vacuum on the sampling canister reaches
near 2 to 3 inches of mercury of vacuum (or per laboratory’s instructions) in the
sampling canister after sample collection for comparison with the vacuum
measured upon laboratory receipt to identify possible canister leaks during sample
shipment. Record the time sampling was completed and the final vacuum reading.
 Disassemble sampling train. For temporary sampling points, remove sampling
point and patch floor slab using patching compound and putty knife. If a permanent
or flush mount sampling point is being used, place flush mount cover in the 1 1/2-
inch diameter hole.
 Deliver/ship sampling canisters maintaining chain-of-custody. Sampling canisters
are typically sent back to the laboratory in originally supplied box and packaging
and do not require cooling/chilling.
7. REFERENCES
 No specific references for this procedure are required.
8. TRAINING AND CERTIFICATION
 Training of new hires and less-experienced staff to be completed by skilled project
staff, PM, APR or SME.
 Check Terracon University for training modules that may be available.
Attachment: Field Data Form: Sub-Slab Soil Gas Sampling
Standard Operating Procedure E.2128
SOP E.2128 Sub-slab and Surface Vapor Sampling v.1.0 9-9-24.docx

E.3000
BULK SAMPLING OF SUSPECT ASBSETOS-CONTAINING MATERIAL (ACM)

Last Review or Revision: June 2010

I. PURPOSE

The purpose of this standard operating procedure (SOP) is to provide information on the
hazards of asbestos and procedures to follow to sample suspect materials for laboratory
analysis. The following guidelines contained in this document apply to Terracon personnel who
engage in bulk sampling of suspect ACM and are designed to provide standardization with
respect to sample collection. This procedure should ensure that potential asbestos-
containing material samples are collected in a manner which allows for accurate analysis of
the material and that sampling personnel are protected against potential asbestos fiber
releases through controlled sampling techniques or appropriate personal protective
equipment.

The objective of bulk sampling building materials and components suspected to contain
asbestos is to characterize the items that contain asbestos in quantities equal to or greater
than 1% or other contaent limit as specified by local or state guidelines. By characterizing the
locations and quantities of asbestos-containing materials (ACM), exposure hazards can be
greatly reduced.

II. BACKGROUND AND REFERENCE

Asbestos has been a common component used in several building materials because of its
strength enhancing and fire resisting properties. However, asbestos has been recognized
as a human carcinogen and respiratory hazard. Due to its health hazards, building
inspections and asbestos bulk sampling is requested for schools and many public or
commercial properties prior to building renovation or demolition activities. Therefore,
identifying, locating and quantifying materials containing asbestos is essential in the effort to
prevent worker exposure to asbestos and prevent environmental contamination.

As a consequence of inhalation of asbestos fibers, a body of federal and state regulations
has been developed. Federal regulations pertaining to asbestos are included in AHERA
(Asbestos Hazard Emergency Response Act) US EPA 40 CFR 763, Subparts E, F;
NESHAP (National Emissions Standards for Hazardous Air Pollutants (EPA 40 CFR 61);
OSHA Asbestos Standards (29 CFR 1910.1001 and 29 CFR 1926.1101), and ASHARA
(Asbestos School Hazard Abatement Reauthorization Act). Many states and local
authorities have additional requirements including state-specific licensing and certification.
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TSOP E.3000 Terracon
2

Terracon will comply with applicable federal, state and local regulations when conducting
asbestos-related services.

III. EQUIPMENT

The minimum equipment necessary to conduct bulk sampling of suspect materials, in
addition to the personal protective equipment outlined below in the Health and Safety
Section, is listed below.

 Utility Knife, Chisel, Hammer, Screwdriver, Coring Tool
 Duct Tape
 Sample Containers (preferably ziplock-style clear plastic bags)
 Sample Labels and Indelible Marker
 Spray Atomizer containing Detergent Amended Water, Paper Towels/Wet Wipes
 Spray Adhesive
 Roof Patch Kit (if necessary)
 Measuring Wheel
 Camera
 Flashlight
 Field ACM Sample Log

IV. CERTIFICATION

Individuals conducting asbestos sampling must have the certifications listed below. Copies of
these certifications and licenses should be taken to the site during the sampling event.

 United States Environmental Protection Agency Building Inspector training (and refresher
training, if applicable)
 Asbestos Inspector State-license for the state of the project location (where necessary)

In addition, Terracon requires company-based training courses and hands-on experience of
employees prior to commencing asbestos-related field services. Each employee must also
receive respirator training, be medically monitored and successfully pass a fit-test utilizing
issued respirator(s).

V. HEALTH AND SAFETY

Asbestos has been recognized to cause asbestosis, cancer of the lungs and digestive tract
and mesothelioma. Asbestosis is a lung disorder characterized by a diffuse interstitial
(between cell) fibrosis. The onset of asbestosis probably depends upon the asbestos dust
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TSOP E.3000 Terracon
3

concentration, the morphology of the fiber and length of exposure. Cigarette smoking is
strongly implicated as a co-carcinogenic among asbestos workers.

Under the OSHA asbestos standards, the employer has an obligation to protect employees
against exposure to asbestos fibers in excess of 0.1 fibers per cubic centimeter of air
(0.1f/cc). Personnel engaged in asbestos-related activities (including building inspections)
must be trained, medically cleared and fit-tested for respiratory protection. Therefore,
enrollment in a medical surveillance program in compliance with the OSHA asbestos and
respiratory protection standards is mandatory. Terracon employees are not permitted to
engage in asbestos-related activities unless they are enrolled in the Terracon medical
surveillance program and have been medically cleared for respirator use by a physician.
The following safety and health protocols apply to Terracon personnel who engage in asbestos-
related services. The guidelines contained in this document are based upon potential health
hazards from exposure to asbestos fibers and physical hazards which may be encountered on
survey project sites. Field activities will be performed in accordance with the procedures
outlined in this document and applicable federal/state health and safety regulations.
Terracon personnel will use professional judgment during sample collection to prevent exposure
to other building occupants. If unauthorized personnel attempt to enter a sampling area which
could reasonably pose a fiber release hazard, the inspector will curtail bulk asbestos sample
collection activity and request that the individual(s) leave the work area. If unauthorized
personnel refuse to leave the work area, immediately contact the Project Safety Officer and/or a
client representative. Sample collection activities should recommence only after unauthorized
personnel have left the work area.

In the event that minor amounts of suspect asbestos containing materials such as thermal
system insulation, sprayed-on or trowled-on surfacing materials, ceiling texture, etc. are
released during the course of sampling, sampling team members will immediately evacuate the
area and don Level C personal protective equipment. The area of potential ACM release will
then be approached and suspect materials will be thoroughly wetted with amended water,
slowly and deliberately swept to a centralized pile, re-wetted, and containerized in heavy mil
asbestos disposal bags. Affected surfaces will then be re-wetted and swabbed with clean
cloths or paper towels. Used wipes will be disposed of as asbestos-containing waste.

In the event that large quantities of potential ACM is released during sample collection activities,
personnel will immediately evacuate the area and notify the Project Safety Officer and the client
representative. The Project Safety Officer will request that the area be sealed until a properly
attired response team can be mobilized to the area with a high efficiency particulate air filter
(HEPA) vacuum and other equipment necessitated by site conditions.
If suspect materials are in deteriorated condition and fiber release appears likely, or if
sampling must be conducted overhead and/or above drop ceilings, personnel will upgrade to
Level C personal protective equipment as itemized above. Level C personal protective
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TSOP E.3000 Terracon
4

equipment should be donned before moving drop ceiling panels, attic access panels, etc.
where friable fireproofing or thermal system insulation are known to be present.
The indicated personal protective equipment shall be mobilized to asbestos sampling project
sites on each day of sample collection and utilized, if necessary:
 Tyvek (standard) protective coveralls
 Half face or full face air purifying respirator equipped with HEPA (P-100) cartridges
 Impermeable gloves (nitrile or latex).
 Tyvek boot covers or washable outer footwear

Additional Health and Safety protocols such as those established by the owner/operator of the
project site and Terracon’s company policy regarding ladder safety, confined space entry and
electrical hazards shall be followed.

VI. SAMPLING HAZARDS

a. Elevated Surfaces

Asbestos building inspections may include roofing materials and ceiling spaces containing
suspect ACM. Appropriate ladders or other suitable devices (e.g., manlifts) will be used for
gaining access to elevated sampling locations. Ladders will be inspected prior to use.
Spreaders will be fully extended on all step ladders and firmly positioned prior to use.
Where footing is uncertain, a sample team member will hold or otherwise secure ladders
while in use by another sample team member. Personnel must always face ladders during
both ascent and descent. Extension ladders will not be positioned more than one-quarter of
their working length from buildings, walls, etc. (4:1 pitch). Sample team personnel will not
walk on steeply pitched roof surfaces and will not walk on low pitched roofing surfaces while
wet. Remain on designated roof walkways wherever present. Terracon personnel will
visually inspect roofs prior to beginning sample collection activities and will avoid all areas
which appear to be structurally unsound.

b. Confined Space Entry

Terracon asbestos inspectors will not enter any pit, shaft, tunnel, etc. which has limited
means of egress, the potential for an oxygen deficient or toxic atmosphere or which was not
designed for human occupancy without first developing a written safety plan which includes
a confined space entry permit and procedures. Readily accessible spaces such as pipe
tunnels in which personnel may stand can be entered to a distance where continuous visual
and verbal communication can be maintained with another sample team member.

Adequate portable lighting must be utilized during sample collection in tunnels and similar
spaces. No Terracon or sample team member may attempt to walk through a pipe tunnel,
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TSOP E.3000 Terracon
5

etc. beyond the sight of a stand-by team member unless written confined space entry
procedures have been prepared for the project.

c. Electrical Contact Hazards

Personnel will remain cognizant of the location and condition of electrical wiring during the
collection of bulk asbestos samples. A visual assessment of each work space will be made
prior to sample collection and electrical contact hazards will be evaluated. Unguarded
junction boxes, exposed wiring, knife switches, etc. will be avoided during the collection of
bulk ACM samples, and coring tools will not be used in near proximity to electrical switches
or receptacles.

VII. PROCEDURES FOR BULK SAMPLING OF SUSPECT ACM

The primary purpose of this section is to identify the methods and techniques of controlled
sampling, sampling site control and use of appropriate personal protective equipment to
protect Terracon personnel and members of the general public from exposure to asbestos
fibers during sampling activities. Adherence to these procedures should enhance personnel
safety during sample collection activities and aid in the suitability of samples for analysis.
Field activities will be performed in accordance with the procedures outlined in this document
and applicable federal/state health and safety regulations.

Protocols for inspection and bulk sampling are defined in AHERA regulations. These are
applicable for any type of survey; for example, a school, an area prior to renovation, a
building prior to demolition and inspections undertaken to rebut the OSHA presumption that
certain materials contain asbestos.

An accredited Building Inspector must perform the inspection. A summary of AHERA
sampling protocols is as follows:

1. Visually inspect the building interior and/or exterior and identify locations of suspect
ACM. Identify homogenous areas of friable and non-friable suspect ACM. Document
locations, condition, classification and estimated quantities of each suspect material. It is
recommended to depict locations of materials on a building diagram and take photographs
of sampled materials.
2. Touch each suspect ACM to determine its friablity.
3. Collect representative samples of suspect ACM. Terracon recommends a minimum of
three (3) samples of each material be collected from each homogeneous area. However,
specific materials may require additional samples such as surfacing material and insulation
Draft
TSOP E.3000 Terracon
6

as described below. Judgment should be used on the need for and quantity of additional
sample collection.
Surfacing materials: Collect, in a statistically random manner, at least 3 bulk samples
from each homogenous area of 1,000 sq. ft. or less, at least 5 bulk samples from
each homogenous area that is greater than 1,000 sq. ft. but less than or equal to
5,000 sq. ft., and at least 7 bulk samples of each homogenous area larger than
5,000 sq. ft.

Thermal System Insulation (TSI): Collect, in a randomly distributed manner, at least
three bulk samples from each homogeneous area of TSI; collect at least one bulk
sample from each homogeneous area of patched TSI if the patched section is less
than 6 linear or square feet; collect bulk samples from each insulated mechanical
system where cement or plaster is used on tees, elbows, etc. in a manner sufficient
to assess whether the material is ACM.

If fiber release appears likely, wet methods will be employed in the collection of suspect
ACM samples. Water amended with a minimum of 10% commercially available window
cleaning solution or other suitable surfactant should be used to moisten materials prior to
sampling. Bulk asbestos samples will not be collected over the heads of, or in near
proximity to, non-project personnel. Respiratory protection is not required when sampling
non-friable suspect materials or materials below the breathing zone which are adequately
wetted with amended water.

4. Bulk ACM samples should be immediately placed in sample containers and sealed
while the materials are wet. If collecting samples of friable ACM or normally non-friable
materials which are in deteriorated condition, precautions must be taken to prevent the
release of fibers to the work area. Precautions include aggressively wetting the surface or
potentially isolating the material (e.g. glove bagging) prior to disturbance.

5. Reusable sampling equipment will be gently rinsed with amended water. Dry the
equipment with paper towels to be disposed of as contaminated materials.

6. The following decontamination sequence should be used following sample collection
activities requiring Level C personal protective equipment:
 Remove coveralls slowly turning the outside inward.
 Place in heavy mil asbestos disposal bag.
 Remove gloves and shoe covers (if utilized)
 Remove respirator and carefully dispose of respirator cartridges in asbestos disposal
bag.
 Securely seal protective clothing and any potentially contaminated disposable
sampling equipment in heavy mil asbestos disposal bags.
 Do not smoke or eat with soiled hands.
Draft
TSOP E.3000 Terracon
7

 Wash hands, face and forearms thoroughly before eating, drinking smoking or using
toilet facilities.
 Shower thoroughly as soon as possible upon leaving the project site.

7. Bulk sample analysis for asbestos content is performed by polarized light microscopy
(PLM). The analytical testing procedure is based on U.S. Environmental Protection Agency
(EPA) methods and National Voluntary Laboratory Accreditation Program (NVLAP)
requirements. Terracon will use NVLAP accredited and appropriately licensed laboratories
for analysis of asbestos bulk samples. Samples will be controlled with the analytical
laboratory through chain of custody documentation.

Draft
Appendix C
PFAS Sampling Guides
PFAS EPA Method 1633 SAMPLING INSTRUCTIONS
Non-Potable Water and Solids
PLEASE READ INSTRUCTIONS ENTIRELY PRIOR TO SAMPLING EVENT
Sampling for PFAS can be challenging due to the prevalence of these compounds in consumer products. The
following guidelines are strongly recommended when conducting sample collection for EPA Method 1633
(January 2024).

This guide is limited in use to collection of non-potable water and solids for analysis by EPA Method 1633.

Note that it is possible that project-specific data quality objectives, QAPP requirements, or state-specific
sampling guidance documents may include modifications or additions to the following guidance. As such,
please always consult your applicable agency stakeholder as the primary reference guide. This document
contains basic sampling guidance, focusing on elements of sample collection needed to facilitate the
collection of samples in the proper containers.

CLOTHING and PPE
• No clothing or boots containing Gore-Tex™.
• Safety boots must be made from polyurethane or PVC.
• No materials containing Tyvek®.
• Do not use fabric softener on clothing to be worn in the field.
• Do not use cosmetics, moisturizers, hand cream, or other related products the morning of sampling .
• Do not use unauthorized sunscreen or insect repellant.
• Wet weather wear - made of polyurethane and PVC only.

FOOD CONSIDERATIONS
• No food or drink on site except for bottled water and/or hydration drinks (e.g., Gatorade®) that are
available for consumption only in the Support Zone.

SAMPLE CONTAINERS
• Sample containers made of HDPE or polypropylene are required and supplied by the laboratory.
• Caps are unlined and made of HDPE or polypropylene (no Teflon®-lined caps).
• Please see Exhibit 1 for more details regarding sample containers. If you have questions, please contact
your project manager (name/number typically provided in container order).

PREPARATION FOR SAMPLING
Sampler must wash hands and then put on nitrile gloves in order to limit contamination during sampling. Each
sample set requires a set of containers to comply with the method as indicated below. A sample set is
composed of samples collected from the same sample site and at the same time.
Draft
PFAS EPA Method 1633 SAMPLING INSTRUCTIONS
Non-Potable Water and Solids
Sampling Instructions – Non-Potable Water
1. Collect a non-potable water (NPW) sample in the supplied 2 X 500 mL HDPE containers. Note for landfill
leachate you will receive 3 X 125 mL HDPE containers. Place each set of sample containers in a clear plastic
resealable bag.
2. If you choose to collect a field or equipment blank, you will receive one (1) empty 500 mL container and
one (1) 500 mL container containing PFAS-free water. Transfer the PFAS-free water into the empty
container at the time of sampling for a field blank or use the 500 mL of PFAS-free water as a final rinse step
and collect as an equipment blank.
3. When completing the chain of custody (COC), each bag of containers must be listed as individual line
items. Each line is considered an individual sample by the laboratory. Include the # of containers for each
sample on the COC.
4. Complete and affix the labels directly onto the sample containers.
5. When packing the samples in a cooler, ensure the caps are tight. Keep the containers in the plastic bags
and pack the bags amongst adequate amounts of ice.
6. The temperature of the samples must be 4 ± 2°C when received by the laboratory.
Sampling Instructions – Solids (soil, sediment, etc.)
1. Collect a grab sample of approximately 100 grams in a 90 mL or 125 mL container. For solids, any PFAS-
suitable container can be used as long as at least 50 grams per sample is provided. Place each set of
sample containers in a clear plastic resealable bag.
2. Complete and affix the label directly onto the sample container.
3. When packing the samples in a cooler, ensure the lids of the sample containers are tightly sealed.
4. The temperature of the samples must be 4 ± 2°C when received by the laboratory.

Please see Exhibit 1A for details regarding containers, Exhibit 1B for container pictures, and Exhibit 2 for
details regarding holding times for EPA Method 1633.
Draft
PFAS EPA Method 1633 SAMPLING INSTRUCTIONS
Non-Potable Water and Solids
Exhibit 1A – Container Requirements Using EPA Final Method 1633

Matrix
Category Matrix Detail Containers (Per Sample) Comments
AQ NPW (GW,
WW, SW)
2 x 500 mL For MS/MSD (if requested1), collect 6 x 500 mL.
AQ Landfill
Leachate
3 x 125 mL NOTE: this is not TCLP/SPLP leachate, this is landfill leachate, i.e., a very
specific matrix per the method. We only target extracting
approximately 100 mLs for landfill leachate per the method
requirement. Extracting this volume results in a 5X increase in
reporting limits (relative to NPW). For MS/MSD (if requested), collect 6
x 125 mL. NOTE: it is acceptable if this matrix is collected in a larger
PFAS container for whatever reason. In this instance, the lab will
subsample for preparation/analysis, and this will be narrated in the
report.
SOLID Soil/Sediment 1 x 90 mL straight-sided
(preferred)
- OR -
1 x 125 or 250 mL
This straight-sided 90 mL container is available in our PFAS container
program and is optimal for solids. However, we can use standard 125
mL or even 250 mL containers for this matrix, if they originate from our
PFAS container program. No additional volume needed for MS/MSD
sample (if requested). NOTE: for "biosolids," please see next row.
SOLID Biosolid 1 X 125 mL If a sample is identified as a "biosolid" then use this 125 mL container.
For MS/MSD (if requested), collect 2 x 125 mL. Note that "biosolid" is
often colloquially called "sludge." Method 1633 considers biosolid a
separate matrix, and there is a specific extraction protocol that is
different than other solids, resulting in a 10X increase in solid reporting
limits. As with the soil/sediment matrix, a larger PFAS container (e.g.,
250 or 500 mL) is also acceptable.
Draft
PFAS EPA Method 1633 SAMPLING INSTRUCTIONS
Non-Potable Water and Solids
Matrix
Category Matrix Detail Containers (Per Sample) Comments
Field QC Field Blank (FB) 1 x 500 mL (PFAS-free water)
1 x 500 mL (empty)
Necessity and frequency are determined by client as this is a field QC
sample. It is not a method requirement. The sampler transfers the
water into the empty container, and that becomes the FB sample.
Field QC Equipment
Blank (EB)
1 x 500 mL (PFAS-free water)
1 x 500 mL (empty)
Necessity and frequency are determined by client as this is a field QC
sample. It is not a method requirement. PFAS-free water is used after
routine decon procedures to demonstrate decon efficacy. Use the
provided 500 mL for this sample collection and collect into the empty
container provided; this becomes the EB sample container.
QC Trip Blank 1 x 500 mL (PFAS-free water) This is not frequently requested, and not required by the method.
There are some clients’ and/or State regulatory guidance documents
that require them. If collected and analyzed, this is a billable sample.
QC MS/MSD MS/MSD samples are not unilaterally required by the method. If your project requires MS/MSD
samples, make sure you communicate the number of MS/MSD samples required. For any MS/MSD
sample, see above for required sample containers. Please note that MS/MSD analyses are billable
samples (because they are not required) and thus result in an additional two (2) invoiced samples.
NPW = non-potable water
GW = groundwater
WW = wastewater
SW = surface water
Draft
PFAS EPA Method 1633 SAMPLING INSTRUCTIONS
Non-Potable Water and Solids
Exhibit 1B – Pictures of Method 1633 Containers

Solid container is a 90 mL
polypropylene bottle (pictured).
However, larger containers (e.g.,
125 mL or 250 mL) containers can
be used, as long as they are part of
the Pace PFAS container program.
Aqueous NPW sample set, consisting of 2 x 500 mL. Fill to
dotted line. Note that for landfill leachate, if we are
alerted in advance, you will receive 3 x 125 mL.
Draft
PFAS EPA Method 1633 SAMPLING INSTRUCTIONS
Non-Potable Water and Solids
Exhibit 2 – Holding Times for EPA Method 1633

Matrices Stored at 0 - 6 °C, protected from light Stored at -20 °C, protected from light
Holding Time Caveats (from Method) Holding Time Caveats (from Method)
SAMPLES (Two Lab Storage Conditions with Associated Holding Times)
Aqueous 28 days “Issues were observed with certain
perfluorooctane sulfonamide
ethanols and perfluorooctane
sulfonamidoacetic acids after 7
days”
90 days None
Solid 90 days “samples may need to be extracted
as soon as possible if NFDHA is an
important analyte”
90 days “samples may need to be
extracted as soon as possible if
NFDHA is an important analyte”
Biosolid 90 days None 90 days None
Tissue NA NA 90 days Must arrive <6°C. See NFDHA
caveat (solids)
EXTRACTS (Two Lab Storage Conditions with Associated Holding Times)
All 28 days None 90 days @ <6°C “issues were observed for some
ether sulfonates after 28 days.”

Draft
December 2022
PFAS in the metal plating and
finishing industry
An inventory of information about PFAS use, environmental release pathways, and source
reduction strategies.
PFAS Inventory Analysis
Draft
Minnesota Pollution Control Agency
520 Lafayette Road North | Saint Paul, MN 55155-4194 |
651-296-6300 | 800-657-3864 | Or use your preferred relay service. | [e-mail]
This report is available in alternative formats upon request, and online at www.pca.state.mn.us.
Document number: gp3-05

Authors
Maya Gilchrist

Reviewers/acknowledgements
Sophie Greene
Yodit Sheido
Catherine Neuschler
Erik Smith
PFAS Lateral Team

Editing and graphic design
Paul Andre
Lori McLain

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i
Contents
Tables .................................................................................................................................................. ii
Figures ................................................................................................................................................. ii
Abbreviations ..................................................................................................................................... iii
Overview ............................................................................................................................................. 1
Metal plating and finishing in Minnesota ............................................................................................. 3
Industry classification ....................................................................................................................................... 3
Timeline of important dates ................................................................................................................. 6
Metal plating and finishing operations ................................................................................................. 7
Chrome plating ................................................................................................................................................. 7
Processes associated with PFAS ..................................................................................................................... 10
PFAS in products ............................................................................................................................................. 11
Non-chromium metal plating ......................................................................................................................... 12
Overview ........................................................................................................................................................ 13
Processes associated with PFAS ..................................................................................................................... 14
PFAS in products ............................................................................................................................................. 14
Overview ........................................................................................................................................................ 16
Processes associated with PFAS ..................................................................................................................... 17
PFAS in products ............................................................................................................................................. 18
Potential PFAS release pathways ....................................................................................................... 19
Wastewater .................................................................................................................................................... 19
Solid waste ..................................................................................................................................................... 19
Air ................................................................................................................................................................... 20
Products ......................................................................................................................................................... 20
Accidental releases ......................................................................................................................................... 20
Source reduction considerations ........................................................................................................ 22
Supplementary information ............................................................................................................... 24
References ......................................................................................................................................... 24

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ii
Tables
Table 1. Metal finishing industry classes encompassing business operations representing potential
sources of PFAS……………………………………………………………………………………………………………………………………….4
Table 2. Summary of select PFAS used in chrome plating and adjacent operations………………………………...8
Table 3. Summary of select PFAS used in non-chromium metal plating………………………………………………...12
Table 4. Summary of select PFAS used in metal coating and treatment operations……………………………….15
Figures
Figure 1. Potential metal finishing facilities in Minnesota………………………………………………………………………..5

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iii
Abbreviations
6:2 FTS 6:2 Fluorotelomer sulfonic acid
Cr(III) Trivalent chromium
Cr(VI) Hexavalent chromium
CalEPA California Environmental Protection Agency
ECTFE Ethylene chlorotrifluoroethylene
EPA Environmental Protection Agency
FEP Fluorinated ethylene propylene
FEVE Fluoroethylene vinyl ether
GAC Granulated activated carbon
HDPE High density polyethylene
MPCA Minnesota Pollution Control Agency
NAICS North American Industrial Classification System
NESHAP National Emission Standards Hazardous Air Pollutants
PVDF Polyvinylidene fluoride
PFAAs Perfluoroalkyl acids
PFAS Per- and polyfluoroalkyl substances
PFBS Perfluorobutanesulfonate
PFCAs Perfluoroalkyl carboxylic acids
PFECHS Perfluoroethyl cyclohexyl sulfonate
PFHxA Perfluorohexanoic acid
PFOA Perfluorooctanoic acid
PFOS Perfluorooctanesulfonic acid
PFPE Perfluoropolyether
PFSA Perfluoroalkyl sulfonate
PTFE Polytetrafluoroethylene
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PVC Polyvinyl chloride
SIC Standard Industrial Classification System
SNUR Significant new use rule
TCEQ Texas Commission on Environmental Quality
TSCA Toxic Substances Control Act
UNEP United Nations Environment Programme
WA/FS Wetting agent/fume suppressant
WWTP Wastewater treatment plant
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PFAS in the metal plating and finishing industry • December 2022 Minnesota Pollution Control Agency
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Overview
Metal plating and finishing processes serve to add resistance to wear, corrosion, and heat, as well as to
add lubricity, electrical conductance, and aesthetic properties to base materials. Per- and polyfluoroalkyl
substances (PFAS) have been used across this industry sector as wetting agents, fume suppressants,
dispersion products, coating additives, corrosion inhibitors, and more. The chrome plating industry in
particular has received considerable regulatory and scientific attention as a source of PFAS to the
environment, since perfluorooctanesulfonic acid (PFOS) and other PFAS have been used for decades as
agents to suppress emissions of hexavalent chromium (Cr(VI)), a known carcinogen. Source
identification studies conducted by the U.S. Environmental Protection Agency (EPA) and state agencies
have concluded that the metal finishing industry represents a significant source of PFOS emissions to
wastewater treatment plants (WWTPs), and that within the metal finishing industry, facilities
performing chrome plating and associated operations represent the dominant sources (EPA, 2009; EPA,
2021a; MI EGLE, 2020b). However, PFAS are associated with several finishing processes for chromium
and other metals, including electroplating, electroless plating, anodizing, coating, etching, and cleaning.
Examples include the use of polytetrafluoroethylene (PTFE) in electroless nickel plating and powder
coating, PFAS-based deposition aids in copper plating, PFAS-based wetting agents in metal plating on
plastics, and fluorochemical blocking agents in aluminum foil production.
The primary pathway for PFAS release to the environment from metal finishing facilities is through
wastewater. PFAS are used as agents in chemical baths in which metal finishing operations are
performed. When the baths are replaced, toxics such as Cr(VI) are removed, and the remaining water,
including the PFAS, is discharged. Air emissions are also significant, due to the potential of PFAS
aerosolization from finishing tanks and subsequent release through facility vents. PFAS may also be
present in waste sludge and in certain metal plated or coated products. An EPA rule effective 2015
banned PFOS use in wetting agents/fume suppressants (WA/FS) in chrome plating and chromium
anodizing operations. However, other PFAS are still used in WA/FS and in other metal finishing
processes. The primary PFAS replacement in WA/FS formulations is 6:2 fluorotelomer sulfonic acid (6:2
FTS, also abbreviated 6:2 FTSA), which degrades in the environment to several compounds including
perfluorohexanoic acid (PFHxA).
There are alternatives to PFAS use in this industry sector. Nonfluorinated WA/FS are commercially
available and viable for plating without Cr(VI) and for etching plastics in preparation for electroplating.
Moreover, some metal finishing facilities have adopted mechanical controls for suppressing chromium
emissions that do not require the use of WA/FS, presenting an alternative for hard chrome plating.
Despite this progress, emissions of PFAS from metal finishing facilities, including PFOS, continue to
occur. This is likely due to the ongoing use of PFAS-containing products as well as persistence of PFAS in
the equipment when PFAS-free alternatives are adopted. Source reduction strategies include limiting
use of PFAS-based agents in metal finishing processes, cleaning and replacing contaminated equipment,
and installing waste pre-treatment technologies at discharging facilities.
The remainder of this report provides information on the metal finishing operations that use PFAS and
discusses the specific applications of PFAS, pathways for environmental release, and opportunities to
reduce PFAS emissions from metal finishing facilities. This information is intended to be useful to
regulators, environmental professionals, and industry workers in conducting mitigation, cleanup, and
programmatic efforts around PFAS. Supplementary information tables are included as part of this report
which detail information about specific chemistries and known trade names for PFAS-containing
products used in metal finishing processes. These lists draw on sources including the scientific literature,
chemical industry, and government reports, but they are not exhaustive. Many PFAS-containing
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PFAS in the metal plating and finishing industry • December 2022 Minnesota Pollution Control Agency
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products are associated with numerous trade names, and information on specific products and
chemicals is often considered proprietary information. A definitive list of products is therefore outside
the scope of this report; however, the information provided here may be used as a basis for further
investigation.

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PFAS in the metal plating and finishing industry • December 2022 Minnesota Pollution Control Agency
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Metal plating and finishing in Minnesota
Industry classification
Several industrial processes falling under the metal plating and finishing sector are associated with PFAS
use. These include the core operations subject to EPA’s Metal Finishing Effluent Guidelines for industrial
wastewater: electroplating, electroless plating, anodizing, coating, chemical etching and milling, and
printed circuit board manufacture (Metal Finishing Point Source Category, 1983). These processes are
therefore covered in this report, with the exception of printed circuit board manufacture. Printed circuit
boards contain PFAS as part of their construction; fluoropolymers including PTFE and perfluoroalkoxy
alkane (PFA) form a fiber-reinforced layer underlying laminates of copper (PSD, 2019; Brown, 2022;
Gaines, 2022). While their manufacture falls under a regulatory point source category, from an industrial
standpoint, it may be best categorized as part of the electronics and electrical components industry (e.g.
Glüge et al., 2020; Gaines, 2022). PFAS use in printed circuit board manufacture is included in this report
as part of discussions on plated products; however, further discussion is outside the scope of this report.
To assess the presence of the metal plating and finishing industry in Minnesota, businesses that may
perform the metal finishing processes likely to use PFAS were identified on the basis of North American
Industrial Classification System (NAICS) codes. NAICS is the standard system used by the federal
government in classifying businesses for the purpose of statistical data collection, analysis, and
publication related to the U.S. business economy. It was implemented to replace the Standard Industrial
Classification (SIC) system and was most recently updated in 2022 (U.S. Census Bureau, 2022). NAICS
codes describing industries that are known to use PFAS have been utilized by government agencies,
research groups, and other organizations to identify potential industrial PFAS sources (e.g. Andrews et
al., 2021; MPCA, 2022a; Salvatore et al., 2022).
The metal finishing operations that are associated with PFAS use and covered in this report are
encompassed by three NAICS codes (Table 1). Minnesota businesses that may perform these operations
were identified by using these NAICS codes in a search of the U.S. Businesses module of Data Axle’s
Reference Solutions database, an annually updated repository of detailed business information in the
United States available for government use (Data Axle, 2022). This search yielded 566 unique facilities
listed with one or more of the metal finishing-relevant NAICS codes (Figure 1). Facilities may have more
than one of these NAICS codes listed in this database, since up to ten codes may be included for each
business. Therefore, any duplicate facilities yielded by the data aggregation process were removed
based on location information. Additionally, business records designated “closed/out of business” were
excluded.

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PFAS in the metal plating and finishing industry • December 2022 Minnesota Pollution Control Agency
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Table 1. Metal finishing industry classes encompassing business operations representing potential sources of
PFAS. The table columns represent a) NAICS codes and titles encompassing metal finishing processes, b) select
index entries for metal finishing operations associated with PFAS use, c) inclusion on MPCA’s criteria for
inclusion in the PFAS Monitoring Plan (MPCA, 2022a), and d) number of facilities with the NAICS code listed in
the Reference Solutions database (Data Axle, 2022).
NAICS
codea NAICS titlea Illustrative index entriesb
On MP
list?c
MN
facility
countd
332812
Metal Coating,
Engraving (except
Jewelry and
Silverware), and
Allied Services to
Manufacturers
• Aluminum coating of metal products for
the trade
• Etching metals and metal products
(except printing products) for the trade
• Powder coating metals and metal
products for the trade No 219
332813
Electroplating,
Plating, Polishing,
Anodizing, and
Coloring
• Anodizing metals and metal products for
the trade
• Chrome plating metals and metal
products for the trade
• Electroplating metals and formed
products for the trade
• Plating metals and metal products for the
trade Yes 110
332999
All Other
Miscellaneous
Fabricated Metal
Product
Manufacturing
• Bathroom fixtures, metal, manufacturing
• Foil not made in rolling mills
• Plated ware manufacturing Yes 284

Data considerations
Importantly, the Reference Solutions dataset contains information about known businesses in
Minnesota performing activities ascribed to the selected NAICS codes. These codes are not self-
reported, but rather assigned by Data Axle. The dataset may include facilities that are not currently
operating under any environmental permits. It may also include businesses performing one or more
operations captured by the NAICS codes beyond the metal finishing processes associated with PFAS that
are included in this report. For example, code 332812 contains index entries for both powder coating
(included in this report) and metal engraving (not included in this report). Further, businesses may be
captured who perform one of the metal finishing operations of interest as a minor portion of business,
even if the major business operations do not involve metal finishing. Relatedly, corporate offices for
companies involved with metal finishing may be captured, even if no metal finishing is performed
onsite. Finally, the list may include duplicates that were not captured by removal based on coordinates,
in the case of multiple listings with differing geographic information.
These limitations may apply to other datasets relying on industrial classification systems to determine
the potential for PFAS use. The maps and facility data included here should not be interpreted as a
definitive list of PFAS users, but rather a visualization of the geographic spread of potential PFAS sources
within the metal plating and finishing industry category.
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PFAS in the metal plating and finishing industry • December 2022 Minnesota Pollution Control Agency
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Figure 1. Potential metal finishing facilities in Minnesota. Facilities have been identified based on NAICS codes
encompassing the metal finishing operations described in this report. Facility location data was retrieved from
the U.S. Businesses module of Data Axle’s Reference Solutions database (Data Axle, 2022).

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PFAS in the metal plating and finishing industry • December 2022 Minnesota Pollution Control Agency
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Timeline of important dates
• Early 1920s: Chrome plating became commercially available (Rudy, 2022).
• 1954: Use of PFAS-based WA/FS in the chrome plating industry was first reported. These were
PFAS with amino functional groups. This “second generation” class of WA/FS followed the
hydrocarbon-based “first generation” WA/FS (Gaines, 2022).
• Early 1970s: Trivalent chromium (Cr(III)) was introduced as a commercially viable alternative to
Cr(VI) in decorative chrome plating (Snyder, 2022).
• Late 1980s/early 1990s: “Third generation” WA/FS begun to be used. These utilized PFAS with a
sulfonate functional group, namely PFOS (Gaines, 2022).
• 1995: EPA finalized a rule limiting Cr(VI) and Cr(III) emissions from metal finishing facilities under
the Clean Air Act (NESHAP, 1995).
• 2007: EPA amended a significant new use rule (SNUR) under the Toxic Substances Control Act
(TSCA) to require reporting of PFAS. The SNUR contained an exception for the use of the
ammonium salt of PFOS as a “fume/mist suppressant in metal finishing and plating baths.
Examples of such metal finishing and plating baths include: hard chrome plating; decorative
chromium plating; chromic acid anodizing; nickel, cadmium, or lead plating; metal plating on
plastics; and alkaline zinc plating” (PFOS SNUR, 2007).
• 2012: EPA finalized a rule to phase out the use of PFOS in WA/FS for hard and decorative
chromium electroplating and anodizing tanks. This rule applied to PFOS only; no other PFAS
were mentioned (NESHAP, 2012).
• 2015: Compliance began for PFOS phase-out as part of the updated National Emission Standards
Hazardous Air Pollutants (NESHAP) requirements (NESHAP, 2012).

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Metal plating and finishing operations
Chrome plating
Key points
• PFAS have been used for decades in wetting agents/fume suppressants in chrome plating baths
to suppress chromium-bearing mist emissions.
• Historically, several PFAS compounds have been associated with chrome plating.
• PFOS was commonly used as an ingredient in wetting agents/fume suppressants up until its
regulatory phase-out beginning in 2012. Since then, 6:2 FTS has been its primary replacement.
• There are alternatives to PFAS-based wetting agents/fume suppressants, including the use of
non-fluorinated surfactants and mechanical controls to suppress fumes.
• In the US, chrome plating represents the most significant source of PFAS to the environment
within the broader category of metal finishing industry.
Table 2. Summary of key PFAS used in chrome plating and adjacent operations. For a more detailed list, see
Supplementary Table S1.
PFAS compound Processes Products
Time period of
concern
Potential media
impacted
Potassium or amine
perfluoroalkyl sulfonate
(PFSA)
Chrome plating and
associated
processes WA/FS 1954 – late 1980s
Wastewater, air,
solid waste,
groundwater, soil
Potassium perfluoroethyl
cyclohexyl sulfonate
(PFECHS)
Chrome plating and
associated
processes WA/FS 1954 – late 1980s
Wastewater, air,
solid waste,
groundwater, soil
Ammonium
perfluorohexylethyl
sulfonate (6:2 FTS-NH4)
Chrome plating and
associated
processes WA/FS 1954 – late 1980s
Wastewater, air,
solid waste,
groundwater, soil
Perfluorooctane sulfonic
acid and derived salts
(PFOS)
Chrome plating,
plating on plastics,
etching, anodizing
Wetting agents,
mist
suppressants,
WA/FS Late 1980s - 2015
Wastewater, air,
solid waste,
groundwater, soil
Perfluorobutanesulfonate
(PFBS) Chrome plating
Mist
suppressants
Unknown
(registered
product in EU)
Wastewater, air,
solid waste,
groundwater, soil
Fluorotelomer sulfonic
acids (6:2 FTS and 6:4
FTS)
Chrome plating,
plating on plastics,
etching, anodizing
Wetting agents,
mist
suppressants,
WA/FS 2000s – present
Wastewater, air,
solid waste,
groundwater, soil

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PFAS in the metal plating and finishing industry • December 2022 Minnesota Pollution Control Agency
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Overview
There are two main types of chrome plating: hard and decorative chrome plating. Hard chrome plating
describes the process of electrochemically applying a relatively thick layer of chromium to base metals
to provide hardness, corrosion resistance, lubricity, and heat and chemical resistance (NESHAP, 2012). It
is widely applied in the automotive industry, aircraft construction, shipbuilding and engineering, railroad
industry, and mold manufacturing for the plastic and rubber industries (ECHA, 2021). Decorative chrome
plating describes the process of plating base materials including brass, steel, aluminum or plastic with
layers of copper and nickel, followed by a relatively thin layer of chromium (NESHAP, 2012). This serves
to provide a bright, decorative finish and a surface resistant to tarnish and wear. Decorative chrome
plating is associated with the manufacture of bathroom and kitchen appliances, car and truck bumpers,
motorcycle parts, and more (ECHA, 2021).
Hard chrome plating has historically been associated with aerosol emissions of hexavalent chromium
(Cr(VI)), which is highly toxic and carcinogenic. Chromium-bearing mist is generated as a byproduct of
the electroplating process, resulting from hydrogen and oxygen evolution of chromic acid leftover in the
chrome tanks after plating operations (Baral & Engelken, 2002). To suppress these fumes, wetting
agents are applied to the chrome baths. These lower the surface tension of the plating solution, which
lowers the size and energy of process gas bubbles and thus reduces the likelihood of mist emission to
the air (ECHA, 2021). EPA has regulated emissions of chromium compounds from the metal plating
industry since 1990 (NESHAP, 1995), although PFAS-containing surfactants have been used as
ingredients in WA/FS since the 1950s (Paulson et al., 2004). Due to their efficiency in controlling Cr(VI)
emissions, their inclusion in WA/FS for hard chrome plating is ubiquitous today.
Decorative chrome plating has also historically employed Cr(VI) and thus PFAS-based WA/FS. However,
since hard plating involves the application of a thicker layer of chromium than decorative plating (10 to
> 300 μm vs. 0.25 μm), decorative plating is associated with significantly lower levels of potential
chromium emissions (Baral & Engelken, 2002). Additionally, in the 1970s, decorative plating with Cr(III)
emerged as commercially available option (Rudy, 2022). In addition to greater industrial efficiency, Cr(III)
has generally low human toxicity compared to Cr(VI) (Baral & Engelken, 2002). The widespread adoption
of Cr(III) over Cr(VI) in decorative chrome plating generally renders the use of PFAS-based WA/FS
unnecessary for this purpose (Gaines, 2022), although it is not disallowed (NESHAP, 2012). Notably, the
shift toward Cr(III) use in decorative chrome plating is relatively recent, and Cr(VI) has still been
commonly used within the past two decades. In 2009, an EPA Region 5 study of Cr(VI)-based decorative
chrome plating facilities found that all the facilities emitted PFOS and other PFAS in their effluent
wastewater (EPA, 2009). A more recent study of PFOS sources in Michigan identified Cr(VI) use by
decorative chrome plating facilities, indicating that PFAS-based WA/FS are likely still employed by
decorative chrome platers (MI EGLE, 2020b).
Chrome plating has historically been associated with many distinct PFAS, although in the past couple of
decades, PFOS has been dominant. In conversation with metal finishing industry representatives, EPA
Region 5 found that PFOS-based WA/FS use had become the industry standard in complying with Cr(VI)
emission regulations (EPA, 2009). A 2007 EPA SNUR regulating PFOS included an exception for the
compound’s use as a WA/FS in metal finishing operations (PFOS SNUR, 2007). However, a 2012 rule
banned the use of products containing greater than 1% PFOS by weight in chrome plating and anodizing
operations by 2015 (NESHAP, 2012). The primary PFAS replacement in WA/FS for chrome plating has
been 6:2 FTS (Ritter, 2010), although 6:4 FTS has also been discovered in fume suppressants (MI EGLE,
2020a). Notably, 6:2 FTS degrades in the environment to PFHxA, which is a PFAS with known toxicity
(ECHA, 2021).
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PFAS in the metal plating and finishing industry • December 2022 Minnesota Pollution Control Agency
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Although several metal finishing operations are associated with PFAS use, state agencies and EPA have
concluded that within this industry category, chromium plating is the most significant source of PFAS to
the environment, primarily via wastewater (MI EGLE, 2020b; EPA, 2021a). Notably, however, not all
chrome plating facilities use PFAS today. WA/FS that do not contain PFAS appear to be on the market
and in use by some facilities. Mechanical controls for suppressing chromium emissions are also possible,
reducing the need for surfactants in the plating baths (MI EGLE, 2020a; MI EGLE, 2020b). Furthermore,
while EPA has not found any current permits requiring treatment or evaluation for PFAS, some facilities
are proactively removing PFAS from effluent wastewater using granulated activated carbon (GAC)
technology (EPA, 2021a).
Anodizing
Anodizing refers to the process of using an acid to form an oxide layer on a metal surface, forming a
nanoporous coated surface. Anodizing may be performed using chromic acid, sulfuric acid, or a
combination of acids (Stevenson, 1994; NESHAP, 2012; AlumiPlate, 2022). Chromium anodizing
specifically is associated with PFAS use and is discussed here due to its similarity to chrome
electroplating with regards to PFAS applications and regulatory framework.
The term “anodizing” refers to the fact that the part to be coated becomes the anode during the
electrolytic processes, as distinct from electroplating, in which it becomes the cathode (Stevenson,
1994). While aluminum and its alloys are most commonly subject to anodizing, other nonferrous metals,
such as magnesium and titanium, can also be anodized. Unlike metal plating, anodizing fully integrates
the metal oxide layer with the underlying substrate, meaning there is no possibility of chipping or
peeling. The resultant surface is porous and can be further processed (AAC, 2022a). Anodizing serves
several purposes, including to increase corrosion and abrasion resistance, provide a decorative
appearance, increase paint and bonding adhesion, improve lubricity, provide electrical insulation, and to
facilitate further plating (Stevenson, 1994). Anodizing is used to strengthen components such as aircraft
parts and underlying materials in architectural structures that are subject to high stress and corrosive
conditions (NESHAP, 2012).
Sulfuric acid anodizing is not suitable for all applications, particularly in anodizing parts that are subject
to the highest levels of stress, such as aircraft parts, or in anodizing parts from which removing all of the
acid may be difficult. This is due to the particularly corrosive nature of sulfuric acid (Stevenson, 1994;
AnoPlate, 2022). However, according to industrial sources—including the Aluminum Anodizers Council—
sulfuric acid is generally preferred over chromic acid anodizing (e.g. AAC, 2022b; AnoPlate; 2022).
Where chromium anodizing is performed, PFAS are used similarly as they are in chrome plating: as
WA/FS to minimize chromium misting (EPA, 2021b). Chromium anodizing is regulated in the same way
as decorative chrome plating. Though EPA had less data on chromium anodizing facilities compared to
chrome plating facilities during the rulemaking process, it was determined that the two processes were
similar enough that the same emissions limits for chromium were used (NESHAP, 2012). Furthermore,
chromium anodizing operations and chromium electroplating are collectively the more significant
sources of PFAS to wastewater treatment plants in the metal finishing category due to the use of PFAS-
based WA/FS to control Cr(VI) emissions (EPA, 2021a).

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Processes associated with PFAS
Chrome plating and anodizing baths
In both hard and decorative chrome plating as well as chromium anodizing, PFAS are primarily used to
suppress chromium fumes from the plating baths. PFAS-based surfactants are included as active
ingredients in WA/FS added to the electrolytic baths used to deposit layers of chromium on base
materials, which can include various metals or plastics. The WA/FS lie on the surface of the chrome tank,
lowering the kinetic energy of gas bubbles produced as a byproduct of chromic acid reactions and thus
preventing the escape of chromium-bearing droplets (ECHA, 2021; Finishing.com, 2021). Fume
suppressants may be added to chromium baths by the tank owner (i.e. the facility performing chrome
plating), or purchased by the chrome plater as part of a pre-mixed bath package. There are some
differences between how Cr(VI) and Cr(III) suppressed by a wetting agent are regulated with regards to
work practice and continuous monitoring requirements. EPA’s 2012 rule expanding on emissions
requirements for chrome platers states that in Cr(III)-based decorative plating baths, if a wetting agent is
used, it must be part of a premade bath mixture (NESHAP, 2012).
Decorative chrome plating typically takes advantage of chromic acid baths containing chromium in the
trivalent form Cr(III), which is less toxic than the hexavalent form ((CrVI)) (Baral and Engelken, 2002)
and, as mentioned previously, subject to fewer regulations (NESHAP, 2012). PFAS may still be used in
decorative chrome plating, although alternatives to PFOS-based fume suppressants were more readily
available and adopted for decorative compared to hard chrome plating by the time PFOS began to be
phased out of the industry (UNEP, 2010). In hard and decorative chrome plating operations taking
advantage of chemical WA/FS, 6:2 FTS has been the primary replacement for PFOS. In a recent study of
Michigan chrome plating facilities, about half of the inspected facilities subject to chromium emission
regulations used PFAS-based surfactants (mostly 6:2 FTS-based) in their operations (MI EGLE, 2020b).
Plastic etching
PFAS may also be applied to etching baths to facilitate plastic electroplating. This is performed in
conjunction with decorative chrome plating, whereby plastic base materials are plated with layers of
copper and nickel followed by a thin layer of chromium. Plating on plastics is becoming popular in the
decorative chrome plating industry as a cost-efficiency measure and to create lighter-weight final
products (MI EGLE, 2020). Plastics are made electrically conductive by etching microscopic pores into
the plastic surface to prepare them for chrome electroplating. They are etched in a bath of highly
concentrated chromo-sulfuric acid (ECHA, 2021). Since the acid baths contain Cr(VI), PFAS may be used
as fume suppressants to control air emissions, as in chrome plating on metal base materials (MI EGLE,
2020). PFAS may also be used as stable surfactants added to the acid etch bath to achieve wettability of
the hydrophobic plastic surface (Blepp et al., 2017). Polyfluorinated wetting agents, including those
based on 6:2 FTS, are predominantly used today as an alternative for PFOS (Willand et al., 2022).
Pre-treatment processes
Several pretreatment steps are required to clean aluminum surfaces prior to anodizing. These include
alkaline soaking, etching, vapor degreasing, and/or removal of leftover solvents from the cleaning and
etching processes (TCEQ, 2007). PFAS can be used in the alkaline baths to improve the efficiency and
thus extend the lifetime of the bath (Glüge et al., 2020). They may also be used as wetting agents in the
aluminum etch baths (Gaines, 2022). Pickling with acid or molten-salt baths may be used as a step in the
aluminum cleaning process (Stevenson, 1994). PFAS-based surfactants can be added to pickling baths to
disperse scum, increase bath life, and prevent hydrogen formation and embrittlement (Kissa, 2001).
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PFAS in products
PFOS was commonly used in hard chrome plating from the late 1980s to 2010s, beginning with its
inclusion as a surfactant in third generation wetting agents/fume suppressants and ending with its
regulatory phase-out in the United States and Europe. It has most commonly been used in its salt forms
(Glüge et al., 2020). Quaternary tetraethylammonium perfluorooctane sulfonate has been frequently
used in hard chrome plating (Gaines, 2022), although other PFOS derivatives, such as potassium
perfluorooctane sulfonate, have been used for this purpose as well (Glüge et al., 2020). These WA/FS
exist under several trade names, including Fluorotenside-248, SurTec 960, and Fumetrol 140 (Gaines,
2022), the latter of which was originally developed for the purpose of compliance with EPA chromium
emission standards (Paulson et al., 2004) and found to be used by a majority of Cr(VI) electroplating
facilities included in a 2003 survey by the California Air Resources Board (CalEPA, 2006). Most WA/FS
serve the general purpose of suppressing chromium emissions from plating and/or etching baths, but a
subset are used for a more specific purpose. PFAS dispersion products, which have been manufactured
since 1951, create foam to suppress acid mists and to reduce bath material drag (Gaines, 2022). Some
examples of these include Dupont’s (now Chemours) Zonyl FSN and Chemguard’s fluorosurfactants
tested for use in metal plating (Chemguard, 2007; Gaines, 2022).
Earlier generations of chrome bath WA/FS either did not use a fluorosurfactant or used other
polyfluorinated or perfluorinated compounds. The first generation of WA/FS were hydrocarbon-based,
although these posed fire and health risks and would lead to oxidation, forming Cr(III) as a byproduct.
The second generation of WA/FS were introduced in 1954. These utilized a polyfluorinated or
perfluorinated chain in place of the hydrocarbon. Some active ingredients included potassium
perfluoroalkyl sulfonate (PFSA), amine perfluoroalkyl sulfonate (PFSA), potassium perfluoroethyl
cyclohexyl sulfonate (PFECHS), and ammonium perfluorohexylethyl sulfonate. These WA/FS were more
stable and less prone to oxidation, but their low solubility posed functional issues for the final chromium
plate, leading to the development of the third generation of more highly soluble perfluorinated WA/FS
(including PFOS-based). These are not associated with adverse effects on the final chromium plate
(Paulson et al., 2004).
Presently, fluorotelomer-based substances, perfluoroalkyl acids (PFAAs), and perfluoropolyether (PFPE)-
based substances are used instead of PFOS (Glüge et al., 2020). The primary replacement for PFOS has
been 6:2 FTS, which degrades to PFAS including PFHxA in the environment. In Europe, there is one
perfluorobutanesulfonate (PFBS)-based spray mist inhibitor registered for use in industrial chrome
plating, Bayowet FT 248. Since this product consists of a mixture of PFBS and PFOS, however, it is likely
no longer in use in the US or EU (Lassen et al., 2017). A 2020 study of PFAS at chrome plating facilities in
Michigan found a suite of PFAS present in effluent wastewater, including PFOS and 6:2 FTS in addition to
PFBS, perfluorooctanoic acid (PFOA), other perfluoroalkyl carboxylic acids (PFCAs), and more. The study
concluded that PFOS detections were a product of historical PFOS-based fume suppressant usage (MI
EGLE, 2020b). Many of these compounds have either been historically used or patented for use as
WA/FS in chrome plating. Their presence in emissions from chrome plating facilities could therefore
indicate the historical usage of WA/FS based on these compounds.
A list of PFAS compounds used and/or patented for use in chrome plating operations is included as
Supplementary Information Table S1.

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Non-chromium metal plating
Key points
• Copper and nickel are the most commonly plated metals and serve in a wide variety of
engineering and decorative applications.
• PFAS can be used as surfactants in nickel, copper, and tin electro- and electroless plating to
reduce foaming, improve bath stability, and ensure uniform thickness of the final plate
• In certain electroless plating operations, PFAS are incorporated into the final coating or plate.
Table 3. Summary of key PFAS used in non-chromium metal plating. For a more detailed list, see Supplementary
Table S2.
PFAS compound Processes Products
Time period of
concern
Potential media
impacted
Perfluorooctane sulfonic
acid (PFOS)
Copper, nickel, and
tin electroplating on
metals or plastics;
etching plastics in
preparation for
copper and nickel
plating
Products that
regulate foam,
improve bath
stability, aid in
metal
deposition, and
improve the
quality of the
final plate;
wetting agents 1980s – 2015
Wastewater, air,
solid waste,
groundwater, soil
6:2 Fluorotelomer
sulfonic acids (6:2 FTS)
Copper, nickel, and
tin electroplating on
metals or plastics;
etching plastics in
preparation for
copper and nickel
plating
Products that
regulate foam,
improve bath
stability, aid in
metal
deposition, and
improve the
quality of the
final plate;
wetting agents 2000s – present
Wastewater, air,
solid waste,
groundwater, soil
Polytetrafluoroethylene
(PTFE)
Nickel electroless
plating
Nickel coating
additives 1985 – present
Wastewater, solid
waste,
groundwater, soil,
final plated
products

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Overview
PFAS are used for a variety of applications in both electroplating and electroless plating with metals
other than chrome. Electroplating describes a process by which a material is coated with a layer of a
metal by means of electrolysis. To accomplish this, a charge is applied to the object to be plated by
immersing it in a metal salt solution (Makhlouf & Gajarla, 2020). Electroless plating, or chemical plating,
refers to non-galvanic metal plating performed on a material without the use of an electric current
(Makhlouf & Rodriguez, 2020). Instead, the reactions are forced by the use of a chemical reducing agent
or by the material being plated (Makhlouf & Gajarla, 2020). Electroplating is typically used to deposit
thicker layers of metal (Zhang & Hoshino, 2019), but both electro- and electroless plating serve to
improve corrosion resistance of base materials (Makhlouf & Rodriguez, 2020).
Nickel
Nickel is the most commonly plated metal and has both decorative and engineering applications. It is
valuable for its high level of corrosion resistance and is often used to provide protection to steel parts
(Zangari, 2018). Nickel electroplating can be performed as a standalone coating or as an undercoat onto
which other metals are subsequently plated; for example, decorative nickel plating can be covered by a
thin layer of chromium for applications requiring brilliance. This kind of plating can be found on
automobiles, hardware, and home fixtures. Non-decorative engineering applications include plating
parts used by the aerospace industry, coins, jewelry, and circuit boards (Arnold, 2022). Electroless nickel
plating is performed using chemical nickel plating baths consisting of phosphorous-containing acid and
the nickel substrate. This type of coating provides a low friction surface and wear- and corrosion-
resistance, and it is commonly used in plating fixtures and doorknobs (McKeen, 2016).
In nickel electroplating, PFAS, including PFOS, have been used to improve stability of the electroplating
bath and enhance overall performance (Cheremisinoff, 2017; Gaines, 2022). PTFE powder can be added
to electroless nickel plating baths to provide stability and is incorporated into the final plate (McKeen,
2016). Fluorosurfactants are not specifically mentioned in the Nickel Plating Handbook published by the
Nickel Institute, but anionic surfactants are typically used as wetting agents to lower the surface tension
of bath solutions during nickel electroplating (Nickel Institute, 2014). Information provided by
manufacturers of commercial organic additives commonly used in nickel electroplating confirmed the
use of alkyl or lauryl ether sulfate sodium salt as wetting agents, but the reference study does not
specifically mention fluorosurfactants (Schmitz et al., 2016).
Copper
Copper is the second most commonly plated metal and, like nickel, can be used for decorative or
engineering purposes. A copper plate can provide corrosion resistance, enhanced conductivity, and
improved surface adhesion. It can be coated underneath other metal plates to provide enhanced rust
resistance in highly corrosive environments. Copper plating is considered advantageous over other
metal plating for the low cost of copper and its high thermal and electrical conductivity, ductility, and
plating efficiency (Snyder, 2022). Due to these properties, copper plating is used extensively in the
electronics manufacturing industry, including printed circuit boards, semiconductors, and electrical
cabling, where copper is plated onto wire made of steel or other metals (Miura & Honma, 2003; SPC,
2022). It is also commonly applied to parts used in the oil and gas industry (Electro-Coatings, 2022).
Decorative copper electroplating may be used in the automotive and domestic appliance industries
(Horner, 1999; Weimer, 2017).

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Electroless copper plating involves the deposition of copper from solution onto a base material without
the use of an electric current. This requires use of a copper salt, a reducing agent, and stability of the
plating solution. Additives are required to maintain the latter and are considered proprietary ingredients
of the copper plating baths. Electroless copper plating is slower and more expensive than electroplating,
but its high performance in surface uniformity and ability to coat non-conductive surfaces make it useful
for certain applications. Notable examples are circuit manufacture and decorative and functional plating
on plastics (Deckert, 1995).
Acidic sulfate baths are typically used in copper electroplating and have generally included a variety of
organic additives as constituents to improve the final copper deposit (e.g. Passal, 1959; Volov, 2012;
Marro et al., 2017). PFAS are known to be used in copper electroplating to prevent haziness in the final
plate. These are included as ingredients in chemical additives to copper baths for their ability to regulate
foam and improve the stability of the plated copper (Cheremisinoff, 2017). Furthermore, PFAS can aid in
the deposition of copper during the electroplating process by reducing hydrogen evolution and the
formation of metal oxides. One study demonstrated that the fluorosurfactant Zonyl FSN enhanced
deposition of a copper-tin alloy onto base metals by adsorbing onto the surface of the metal and
becoming incorporated into the final deposit (Pewnim & Roy, 2015). In copper electroless plating, PFAS
are added to the plating solution to disperse free fluoride generated in the acid baths and to improve
the quality of the final plate (Glüge et al., 2020; Gaines, 2022).
Processes associated with PFAS
PFAS use is associated with the metal deposition process in electro- and electroless plating baths. In
copper, nickel, and tin electroplating PFAS can serve as surfactants in acid bath formulations to regulate
foam, reduce the surface tension and increase the stability of the baths, and improve the quality of the
final plate (Cheremisinoff, 2017). In copper electroplating specifically, fluorosurfactants can aid in the
adhesion of the copper to the base material being plated (Pewnim & Roy, 2015; Gaines, 2022). In nickel
electroplating, fluorinated surfactants can be used to prevent foaming and increase the strength of the
final plate by eliminating pinholes, cracks, and peeling (Kissa, 2001). In nickel electroless plating, PTFE
powder is included as an ingredient in chemical bath formulations to enhance lubrication of the final
surface while retaining the mechanical properties of a non-fluorinated hard nickel coating (Ebdon, 1985;
McKeen, 2016; Atotech, 2022a).
In addition to base metal materials, copper and nickel can be electroplated or chemically plated onto
plastics (DuPont, 2022). As a first step, the underlying plastics must be made electrically conductive by
etching with chromic and/or sulfuric acids (ECHA, 2021; DuPont, 2022). Stable surfactants containing
PFOS, 6:2 FTS, or other PFAS alternatives may be added to the acid etching baths to achieve wettability
of the hydrophobic plastic surface (Blepp et al., 2017; Willand et al., 2022).
PFAS in products
PFAS are used as ingredients in baths used to perform copper, nickel, tin, and zinc electroplating, as well
as copper and nickel electroless plating. The PFAS-containing products are added to baths to ensure
even thickness in the final plate, prevent foaming in the bath, and increase the stability of the bath by
reducing surface tension (Cheremisinoff, 2017; Gaines, 2022). PFOS has specifically been cited for use in
these applications historically (Cheremisinoff, 2017), although other PFAS replacements may be used
today. In copper electroplating, the use of PFAS-containing products in the plating bath can help the
copper better adhere to the base material being plated. Zonyl FSN is an example of a fluorosurfactant
that has been shown to be useful for this purpose (Pewnim & Roy, 2015); however, Zonyl
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fluorosurfactant products were discontinued between 2009 and 2014. They have been replaced by a
line of fluorosurfactants called Capstone, which are described to be “based on short-chain molecules
that cannot break down to PFOA or PFOS in the environment” (ChemPoint, 2022). PTFE, the polymeric
PFAS compound commonly known as Teflon, is used as a surfactant in nickel electroless plating baths to
provide lubricating properties to the final plate. The availability of this technology, termed “Niflor,” has
been reported since at least the 1980s (Ebdon, 1985) and is still marketed for use today (e.g. Atotech,
2022a).
A list of PFAS compounds used and/or patented for use in non-chromium metal plating is included as
Supplementary Information Table S2.
Metal coating and treatment
Key points
• PFAS can be used in various types of metal coating, either as WA/FS--as in plating—or as
ingredients in the final coat
• PFAS are often used as cleaning, etching, and other metal surface treatment agents associated
with a variety of metal finishing processes
• PFAS-coated and PFAS treatment products can be found in a wide range of industries, including
the chemical manufacture and architecture industries
Table 4. Summary of select PFAS used in metal coating and treatment operations. For a more detailed list, see
Supplementary Table S3.
PFAS compound Processes Products
Time period of
concern
Potential media
impacted
Perfluorooctane sulfonic
acid and derived salts
(PFOS)
Chromate
conversion coating WA/FS Late 1980s – 2015
Wastewater, air,
solid waste,
groundwater, soil
6:2 Fluorotelomer
sulfonic acids (6:2 FTS)
Chromate
conversion coating WA/FS 2000s – present
Wastewater, air,
solid waste,
groundwater, soil
Polyvinylidene fluoride
(PVDF) Powder coating
Weathering-
resistant
coatings for
products such
as pipelines;
coatings for
steel building
materials 1965 - present
Wastewater, air,
solid waste,
groundwater, soil,
final coated
products
Ethylene
chlorotrifluoroethylene
(ECTFE) Powder coating
Coatings for the
surfaces of
vessels,
reactors,
chemical
storage tanks,
piping, and
semiconductors
1960s/70s –
present
Wastewater, air,
solid waste,
groundwater, soil,
final coated
products

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PFAS compound Processes Products
Time period of
concern
Potential media
impacted
Fluoroethylene vinyl
ether (FEVE) Powder coating
Coatings for
aluminum
window frames
and curtain
walls of
buildings 1970s – present
Wastewater, air,
solid waste,
groundwater, soil,
final coated
products
Perfluorooctanoic acid
(PFOA) Unknown
Nonstick
aluminum oil ? – present
Final products,
other media
unknown
Perfluorobutane sulfonic
acid (PFBS) Unknown
Nonstick
aluminum oil ? – present
Final products,
other media
unknown
Overview
The terms “coating” and “plating” are sometimes used interchangeably, but coating refers to metal
finishing operations meant to provide a durable outer surface that are distinct from electroplating or
electroless plating and can be performed in conjunction with plating for added durability. Cleaning and
other forms of metal treatment are also usually performed in conjunction with other metal finishing
operations. Conversion coating, powder coating, metal cleaning operations, and various specialized
metal treatment operations have been associated with PFAS usage.
Conversion Coating
Conversion coating refers to the process of “converting” the surface properties of the underlying
substrate to those of the metal providing the coating. Unlike plating, where the coating is applied as a
layer on top of the base material, conversion coating alters the base material itself to provide the
desired properties (AST, 2022). Aluminum is a particularly common substrate, although conversion
coating may also be applied to magnesium, zinc, and cadmium. The two principal coating methods are
chromate and phosphate conversion coating, which pickle the surface of the base metal with chromate
or phosphate salt solutions. The reaction with the metal oxide at the surface of the substrate produces a
protective “coating” that is resistant to corrosion and stress and can act as a primer for further coatings.
It can be performed as an alternative to or in conjunction with anodizing (Hughes, 2018; MI EGLE,
2020b).
Importantly, chromate conversion coating can be performed using Cr(VI) and/or Cr(III) solutions (AST,
2022). PFOS has been historically used as a WA/FS for chromate conversion coating. In MI EGLE’s recent
study of PFAS in chrome plating facility effluent, they found that chromate conversion coating, along
with chrome plating, was one of the dominant sources of PFOS to WWTPs within the metal finishing
category, due to use of WA/FS to suppress Cr(VI) fumes. The report notes, however, that facilities
performing chromate conversion coating alone were associated with lower PFOS emissions than those
performing chrome plating. Additionally, as with chrome plating, PFOS emissions appeared to be
associated with historical use, although 6:2 FTS may currently serve as a replacement agent (MI EGLE,
2020b).
PFAS are also associated with phosphate conversion coating, as additives to the phosphating solutions
to help dissolve the oxide layer of aluminum substrates (Glüge et al., 2020).

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Powder coating
Powder coating, unlike conversion coating, does not contribute additional properties to the underlying
metal being coated. Rather, the powder is applied externally to the base material to provide surface
protection and a durable finish (ProPlate, 2022). Powder coatings can be applied either by spraying or
dipping followed by curing with UV or visible light. Polymeric PFAS are often used in powder coating due
to their thermal, fire, and corrosion resistance properties. These coatings may be used on non-metal
surfaces but can be used in metal finishing as well, particularly in coating aluminum and steel. Powder
coating has numerous applications in the architectural and chemical industries, providing protection to
the exterior surfaces of metal bridges and building structures and lining metal tanks and reaction vessels
(OECD, 2022). Within the chrome plating industry, it is considered best practice to use heating and
cooling tanks with PTFE incorporated into the surface (Pullara & Gardner, 2022). Note that only
fluoropolymers, rather than any short- or long-chain PFAS, have been identified for use in powder
coating. There are commercially available alternatives to fluorinated powder coatings, including
products based on high density polyethylene (HDPE), polyvinyl chloride (PVC), and epoxy, although
these may not provide the same degree of thermal and fire resistance as fluoropolymers (OECD, 2022).
Metal treatment and cleaning
PFAS are associated with various treatment and cleaning processes that are performed as steps in the
metal finishing operations discussed in previous sections. In order to plate plastics—and oftentimes
steel and aluminum—the base materials must be electrolyzed via a chemical etching process. PFAS are
often used as agents in these baths to promote wettability of the substrate being etched and/or to
suppress fumes from chromic acid used in the wetting process (Gaines, 2022). PFAS may also be used in
cleaning solutions for plating tanks and other reaction vessels, as well as to pre-treat base metals before
they are further processed by anodizing, conversion coating, or plating (Kissa, 2001). There is
documented use of PFAS as anti-blocking agents for aluminum foil production (Gaines, 2022). Finally,
fluorinated surfactants can be used to promote the flow of metal coatings, prevent cracks during the
drying process, and treat steel surfaces to inhibit corrosion (Kissa, 2001; Glüge et al., 2020; Gaines,
2022).
Processes associated with PFAS
In both chromate and phosphate conversion coating, PFAS use is associated with the process of applying
the base metal to a crystalline salt bath to chemically transform its surface. PFAS-based WA/FS are
applied to chromate baths to suppress Cr(VI) fumes, while PFAS are included in phosphating solutions as
an additive to break down aluminum oxides, in the case of phosphating on an aluminum substrate
(Glüge et al., 2020; MI EGLE, 2020b).
In powder coating, PFAS are incorporated into the final coat and therefore the finished metal product,
as opposed to facilitating the coating process as in conversion coating, anodizing, and plating. PFAS are
included as ingredients in free-flowing powders which are applied via spraying or dipping the base
object, depending on its size and application (OECD, 2022).
Etching is performed on materials with low or no electrical conductivity to create microscopic pores that
enable current flow during electroplating (ECHA, 2021). PFAS-based surfactants may be added to etch
baths to achieve wettability of hydrophobic base materials, in the case of plating on plastics, or to
suppress Cr(VI) emissions when chromic acid is used for etching (Blepp et al., 2017; Gaines, 2022). They
may also be added to alkali aluminum etch baths to improve the efficiency and thus extend the lifetime
of the bath (Glüge et al., 2020). PFOS-based solutions have historically been used to clean machine parts
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following nickel plating operations. Further, PFAS-based surfactants can be used as anti-blocking
additives in aluminum foil production, which reduce the tendency of sheets to stick together (Murphy,
2001; Gaines, 2022).
The use of PFAS-based surfactants in improving the quality of metal coating and inhibiting corrosion on
steel has been documented, which may apply to several operations within the scope of metal finishing.
PFAS in products
PFAS are included as WA/FS in baths used to perform chromate conversion coating. Fluorosurfactants
serve the same purpose for this application as in chromium electroplating—which is to suppress
chromium-bearing fumes—implying that similar products are available and viable for use in chromate
conversion coating. For further discussion, see Section 5.1.3. For a list of PFAS compounds used and/or
patented for use in chrome plating, see Supplementary Information Table S1. Specific PFAS-containing
products for aluminum phosphating have not been named in the referenced literature (Kissa, 2001;
Glüge et al., 2020).
Polymeric PFAS are used in powder coatings broadly applied in the oil and gas industry and chemical
processing and manufacturing. Polyvinylidene fluoride (PVDF) coatings are one of the most commonly
used industrial coatings, originally developed in 1965 under the trademark Kynar (Fonnov, 2018). The
fluoropolymer resin is highly inert and stable, providing protection for weathering. The product Solef,
manufactured by Solvay, is a PVDF-based coating used for internal and external surface coating of
pipelines (OECD, 2022). Ethylene chlorotrifluoroethylene (ECTFE)-based coatings have been in use for
decades and can provide anti-corrosion, chemical resistance, and fire resistance (Solvay, 2019; Solvay,
2022). Halar, also manufactured by Solvay, is an ECTFE-based coating designed for application to the
surfaces of vessels, reactors, chemical storage tanks, and piping (OECD, 2022). Within the electronics
industry, it can also be used to coat semiconductors (Solvay, 2022). Similar fluoropolymers are used in
powder coatings for the architectural industry to provide durability and weather resistance. Fluoplast,
Kynar, and Koflux are PVDF- and hydrocarbon-based coatings marketed as coatings for steel and other
building materials. Fluoroethylene vinyl ether (FEVE)- and fluorinated ethylene propylene (FEP)-based
coatings have been in use for several decades and are reported as coating ingredients in aluminum
window frames and aluminum curtain walls of buildings (Blankenship, 2020; Chemours, 2022; OECD,
2022).
Fluorinated surfactants can be used to treat metal surfaces to provide resistance to physical and
chemical wear. Zonyl FSN and Zonyl FSP have been used to provide water and solvent repellency to
underlying metal surfaces. The fluorosurfactant Atsurf F-21 has been used to inhibit corrosion in steel
surfaces. Various PFAS-based agents can be added to pickling baths used to clean metals for the
purposes of dispersing scum, accelerating acid runoff when the metal article is removed from the bath,
and increase the lifetime of the bath. PFAS are also used in anti-blocking agents, such as Monflor 91, to
prevent sticking of aluminum foil sheets during manufacture (Kissa, 2001). While these agents are
generally not incorporated into the final aluminum foil product, foil marketed as “nonstick” has been
found to contain PFOA and PFBS (Rodowa et al., 2020).
A list of PFAS compounds used and/or patented for use metal coating and treatment applications is
included as Supplementary Information Table S3.
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Potential PFAS release pathways
There are four life cycle stages described for the wetting agents/fume suppressants—which may contain
PFAS—generally used in metal finishing baths:
1. The manufacture of the WA/FS
2. The production of the etching, anodizing, or plating agents and baths
3. The industrial use of these agents for metal finishing operations
4. The disposal of the metal finishing bath (Lassen et al., 2017).
The production of fluorosurfactants and bath formulations are typically performed by distinct parties
from those performing the metal finishing operations. Therefore, this discussion focuses on life cycle
stages (3) and (4).
Wastewater
The primary pathway for PFAS release to the environment from metal finishing operations is via
wastewater. The acid baths used to perform plating and other metal finishing operations have a limited
usage lifetime (Lassen et al., 2017). Once they can no longer be used, the liquid is treated to remove
chromium and other metals and discharged to the sewer system. Common treatment technologies
include electrochemical reduction of Cr(VI) to Cr(III), chemical precipitation, and ion exchange. Use of
adsorptive media such as activated carbon can be used to treat relatively low concentrations of
chromium, and membrane filtration may be used by facilities that reclaim chromium, although this
method is less common and more costly (SAMCO, 2020). Granular activated carbon, ion exchange
resins, and high-pressure membrane systems are the three treatment technologies currently known to
effectively remove PFAS (EPA, 2021c); the traditional metal treatment methods alone will likely not
remove them. At facilities using PFAS-based WA/FS or baths containing PFAS ingredients, absent any
targeted treatment technologies, PFAS likely remain present in the effluent wastewater (NESHAP, 2012).
Furthermore, facilities that are not currently using PFAS-based agents may still discharge PFAS via
wastewater if products containing PFAS were used historically. A 2020 study of chrome finishing
facilities in Michigan found that PFOS was present in effluent wastewater from nearly every facility
included in the study, although no facilities were actively using PFOS-based fume suppressants. It was
concluded that the PFOS discharge was associated with historical usage (MI EGLE, 2020a). A larger
Michigan study of PFAS sources to wastewater treatment plants found that two thirds of metal finishers
were sources of PFOS, despite compliance with the phase-out of these products. One decorative chrome
plating facility built after the 2015 PFOS ban was not a PFOS source to WWTPs, further supporting the
conclusion that historical use can lead to ongoing discharge (MI EGLE, 2020b).
Solid waste
It has been suggested that PFAS may be present in solid waste generated by chrome plating facilities
due to their use as WA/FS in the plating baths (Lu et al., 2017). After removing spent plating baths and
before discharging to the sewer, chromium is removed from the baths by reducing the chromium and
then precipitating the metal hydroxides. This process generates a sludge that is highly concentrated in
heavy metals (de Souza e Silva et al., 2005; Wang et al., 2022). If PFAS-based surfactants are included in
the bath, then treatment of associated wastewaters may result in PFAS-bearing sludge (HRP, 2022).
Sludge containing Cr(VI) is classified as hazardous waste and discharged to hazardous waste
management facilities. Sludge containing primarily Cr(III), however, is not considered hazardous waste
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and is discharged to nonhazardous industrial or municipal waste landfills (Identification and Listing of
Hazardous Waste, 1980).
Air
Air emissions of PFAS may be associated with metal finishing operations. Generally, PFAS can be
released to air by either evaporation or aerosolization. In the metal finishing industry, PFAS may be
released from open vessels and air ventilation canals (Lassen et al., 2017). These could include open
etching, anodizing, and plating baths containing PFAS-based agents as well as facility vent systems. Air
emissions tend to be of greater concern with regards to short-chain PFAS such as PFBS and 6:2 FTS, since
they are both more volatile and water-soluble, enabling gas- and aqueous-phase air transport (Danish
EPA, 2015; Lassen et al., 2017; Riedel et al., 2021). However, long-chain PFAS such as PFOS more easily
adsorb to particles, so they are capable of atmospheric transport via particulate matter (Danish EPA,
2015). Both PFOS and its primary replacement in metal finishing operations, 6:2 FTS, will likely therefore
have an air pathway for environmental release if there are open reactors on site (rather than a closed
reactor system). An illustrative example of this pathway is the case of Douglas Corporation, a chrome
finishing facility in St. Louis Park, MN. PFOS contamination in a nearby lake, Bde Maka Ska (formerly
known as Lake Calhoun), was traced to concentrations in snow and stormwater runoff from the roof of
the facility. PFOS had been accumulating there by way of fumes vented to the roof from the chromic
acid etch tanks inside the facility. After the facility switched to a 6:2 FTS based mist suppression product,
elevated levels of 6:2 FTS were observed downwind from the facilities in ambient air monitors (MPCA,
2022b).
Products
In general, PFAS wetting agents/fume suppressants remain in the baths used to perform metal plating
and other finishing operations. This is specifically noted for chrome electroplating, which comprises the
dominant operation in the broader metal finishing industry category (Lassen et al., 2017). In some cases,
however, PFAS may be incorporated into the final metal product. PTFE is used in electroless nickel
plating as an ingredient in the final coat. Roughly 20-25% of the final nickel plate in products
manufactured via this method will be PTFE (McKeen, 2016). It has also been shown that
fluorosurfactants used in copper electroplating adhere to the base surface onto which the copper is
deposited (Pewnim & Roy, 2015), although it is unclear how much PFAS ultimately remains in the final
product. In powder-coated materials, fluoropolymers comprise a significant portion of the coating.
Therefore, although waste and fumes produced during the manufacturing process of metal plated
articles are the dominant sources of PFAS to the environment, use and disposal of metal plated or
powder coated products may represent a minor source. When there are both industrial and consumer
users of PFAS, however, consumer product use has been found to be an insignificant source PFAS to
WWTPs compared to industrial processes. In a study of PFOS release to wastewater treatment plants,
MI EGLE found that plants with no significant industrial PFOS source received influent water with PFOS
concentrations similar to the background level (MI EGLE, 2020b).
Accidental releases
In addition to the waste streams highlighted above, PFAS may be discharged from metal finishing
facilities by way of leaks, cracks, and corrosion of equipment or facility flooring. The baths used to
perform plating, etching, anodizing, and conversion coating operations are strongly acidic and therefore
corrosive to certain materials. At a chrome plating facility in Minnesota, chromo-sulfuric acid corrosion
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of a steel POP etch tank and subsequent corrosion of the underlying concrete led to a release of Cr(VI)
and other bath chemicals to the groundwater (Carlson McCain, 2020). Bath chemicals—including PFAS—
may also be released to soil and groundwater via spills and leaks from piping, sumps, and other
equipment, as well as from spills occurring during raw material handling (CalEPA, 2011). The possibilities
for accidental PFAS release are numerous, and in many cases, likely to be facility-specific. Further
discussion of these possibilities is outside the scope of this report.

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Source reduction considerations
Fluorinated surfactants are widely used as wetting agents throughout the metal plating and finishing
industry to suppress harmful fumes, stabilize plating baths, and ensure high quality of the final product.
These chemical agents are financially costly; therefore, they are typically used only when alternative
surfactants cannot deliver the required performance (Knepper & Lange, 2012). The original WA/FS used
by the metal plating industry were based on hydrocarbons rather than fluorocarbons; however,
associated health and safety issues as well as process inefficiencies led to the adoption of fluorinated
surfactants (Paulson et al., 2004).
Following emerging evidence regarding the toxicity and persistence of long-chain PFAS and subsequent
regulatory action, PFOS in metal plating surfactants was replaced with 6:2 FTS. Based on information
available to date, 6:2 FTS is considered less bioaccumulative and less toxic than PFOS, but it can be
nearly as persistent in the environment. Its environmental persistence is of concern due to the potential
for continuous exposure, which prevents elimination from organisms despite shorter tissue and serum
half-lives (Lu et al., 2017; Brendel et al., 2018). Additionally, there is comparatively little health risk data
available for 6:2 FTS, and it degrades in the environment to several intermediate PFAS whose toxicities
are not all well-known (Hoke et al., 2015; Sheng et al., 2016). One degradate of 6:2 FTS is PFHxA, which
is associated with toxic effects on development, reproduction, and the endocrine and neurological
systems (MDH, 2021; MDH, 2022).
There is a growing consensus that nonfluorinated WA/FS may be a viable alternative in chrome plating
based on Cr(III), and that transitioning from Cr(VI) to Cr(III) is generally feasible for decorative chrome
plating and plating on plastics. Source reduction efforts may therefore include using the trivalent form
of chromium wherever technically possible, although it has been noted that some facilities may face
logistical and economic challenges surrounding such a transition. Cr(III) is not a feasible substitute in
hard chrome plating, as the level of hardness, corrosion- and wear-resistance provided is insufficient
given the performance conditions of hard chrome-plated parts. In some decorative chrome plating
applications requiring a high level of technical performance, Cr(III) may not be feasible either. The
viability of non-fluorinated surfactants in hard chrome plating applications requires further research and
testing. There are greater safety concerns with the performance of non-fluorinated surfactants in
suppressing Cr(VI)-bearing fumes, since these surfactants are reportedly not as effective (ECHA,
2021). Notably, however, there is at least one WA/FS product marketed for use in plating with Cr(VI)
that is advertised as “PFAS-free” (e.g. Atotech, 2022b). Additionally, a Michigan study of WA/FS used by
chrome plating facilities found one product containing no detectable PFAS when analyzed using existing
targeted and non-targeted methods, although it was not specified whether this product was used for
hard or decorative chrome plating (MI EGLE, 2020a).
Fluorinated surfactants are often used in electroplating on plastics, in the process of etching to enable
electrical conductivity of the underlying plastic. However, nonfluorinated surfactants are viable as non-
toxic and easily biodegradable alternatives. Acid permanganate solutions, nitric acid, and trichloroacetic
acid mixtures have been tested as alternative immersion techniques. Additional safety and technological
controls may be required when using these alternatives, as there is risk of forming nitrous gases with
use of nitric acid, fire risk with permanganate solutions, and the potential for organohalogen compound
formation (ECHA, 2021).
Mechanical controls present an alternative to the use of surfactants in suppressing metal plating fumes.
Performing metal finishing operations inside closed coating reactors would eliminate the need for
surfactants and, by extension, the need for fluorosurfactants (ECHA, 2021). Due to the complexity in
metal finishing processes, there is no single describable way to accomplish a closed system. Different
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technological and safety controls would be required for each combination of possible operations (e.g.
plating, anodizing, etching, cleaning, etc.) (Blepp et al., 2017). Moreover, a closed system presents
unique safety concerns that would need to be addressed, such as the explosion hazard of hydrogen gas
produced during electroplating processes (UNEP, 2021). Nevertheless, enclosures and physical controls
are in use today in the chrome plating industry. In a survey conducted by MI EGLE, about half of chrome
plating facilities regulated for chromium emissions used mechanisms other than chemical fume
suppression, including scrubbers, physical fume suppression methods, and non-fluorinated chemicals. In
the same study, approximately one third of chrome platers were not sources of PFOS to wastewater
treatment plants—despite the potential for legacy emissions based on historical use—indicating that
mechanical controls were likely used by those facilities in the past as well (MI EGLE, 2020b).
Chromate conversion coating relies on fluorosurfactants as WA/FS due to the risk posed by Cr(VI)
emissions. However, advances in conversion coating technology that do not rely on hard chromate may
alleviate the need for this usage. Conversion coatings based on Cr(III), permanganate, rare earth
elements, vanadium, heteropolymolybdate, and others have been tested, although these do not appear
to have been commonly adopted in industry and present drawbacks in durability compared to surfaces
converted with Cr(VI) (Minevski et al., 2002; NCMS, 2002; Pommier et al., 2014). Ongoing research and
development of Cr(VI)-free alternatives to conversion coating and protective coatings for aluminum has
been reported, although these efforts are generally in their early stages, and technical limitations have
been identified for the most demanding applications, such as in the aerospace industry (Henkel, 2017).
There are a number of commercially available non-fluorinated alternatives to powder coatings based on
materials including HDPE, PVC, and epoxy. These may be suitable for some applications, but in
applications requiring a high degree of thermal resistance, such as chemical manufacturing,
fluoropolymers provide higher degrees of thermal resistance.
The potential for PFAS emissions based on historical use invites an opportunity for source reduction
efforts beyond the shift away from using PFAS-based agents at metal finishing facilities. In MI EGLE’s
study, approximately two thirds of chrome plating facilities included were emitting PFOS to wastewater
treatment plants, despite not actively using baths or bath agents containing PFOS. Five of these facilities
were the single industrial PFOS source to their respective wastewater treatment plants. After installing
GAC pretreatment technologies, PFOS concentrations in effluent wastewater were reduced by orders of
magnitude, and there were improvements in solid waste concentrations as well. Extensive cleaning of
metal finishing equipment resulted in some PFOS reduction, but pretreatment technologies were still
required to achieve dischargeable levels. EGLE noted that since PFOS may persist in many surfaces and
conduits—including various tanks, parts, ducts, etc.—cleaning in and of itself is likely not an adequate
source reduction method (MI EGLE, 2020b).
Importantly, there are limits to the capability of treatment technologies in reducing sources of PFAS to
the environment. Though treatment of 6:2 FTS in wastewater is generally more feasible than treatment
of PFOS, there is little known about the destruction or decomposition of fluorotelomers from solid
waste, including chrome-plating sludge (Lu et al., 2017). Other short-chain PFAS such as PFHxA, which is
a degradation product of 6:2 FTS, have low adsorption potential and cannot be as readily removed from
water using granular activated carbon technology (Brendel et al., 2018). Furthermore, removal of any
PFAS in wastewater or solid waste does not necessarily reduce the possibility of aerosol or particulate-
bound air emissions. A combination of minimized PFAS use, equipment cleaning and/or replacement,
and waste pretreatment would likely produce the most significant outcomes with regards to PFAS
reduction from metal finishing sources.
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Supplementary information
Supplementary information tables can be found online as report number gp3-05a, “PFAS in the metal
plating and finishing industry: Supplementary information.”
References
Advanced Surface Technologies. (n.d.). Chromate Conversion Coating. Retrieved September 2, 2022,
from https://www.astfinishing.com/plating-service/chromate-conversion-coating/
AECOM. (2021, April). Evaluation of PFAS in Influent, Effluent, and Residuals of Wastewater Treatment
Plants (WWTPs) in Michigan. Michigan Department of Environment, Great Lakes, and Energy,
Water Resources Division. https://www.michigan.gov/pfasresponse/-
/media/Project/Websites/egle/Documents/Programs/WRD/IPP/pfas-initiatives-statewide-full-
report.pdf
Aluminum Anodizers Council. (a). What is anodizing? Anodizing...the Finish of Choice. Retrieved
September 2, 2022, from https://www.anodizing.org/page/what-is-anodizing
Aluminum Anodizers Council. (b). Current Anodizing Processes. Anodizing...the Finish of Choice.
Retrieved September 2, 2022, from https://www.anodizing.org/page/current-anodizing-
processes#:~:text=Sulfuric%20Acid%20is%20the%20preferred%20method%20among%20anodiz
ers&text=The%20predominant%20anodizing%20process%20today,formed%20in%20a%2015%2
0pct
AlumiPlate. (n.d.). The Ultimate Guide to High Purity Aluminum. Retrieved September 2, 2022, from
https://www.alumiplate.com/solutions/high-purity-aluminum-guide/
Andrews, D. Q., Hayes, J., Stoiber, T., Brewer, B., Campbell, C., & Naidenko, O. V. (2021). Identification of
point source dischargers of per- and polyfluoroalkyl substances in the United States. AWWA
Water Science, 3(5). https://doi.org/10.1002/aws2.1252
Arnold, J. (2022, June 18). Nickel electroplating. Products Finishing. Retrieved August 31, 2022, from
https://www.pfonline.com/articles/nickel-electroplating \
Atotech. (n.d.,a). Electroless Nickel Coatings. MKS | Atotech. Retrieved August 31, 2022, from
https://www.atotech.com/products/general-metal-finishing/wear-resistance/electroless-nickel-
coatings/
Atotech. (n.d.,b). Fumalock: First fluorine-free, non-PFOS, non-PFAS fume suppressant. MKS | Atotech.
Retrieved September 2, 2022, from https://www.atotech.com/products/general-metal-
finishing/wear-resistance/functional-chrome-coatings/fumalock/
Baral, A., & Engelken, R. D. (2002). Chromium-based regulations and greening in Metal Finishing
Industries in the USA. Environmental Science & Policy, 5(2), 121–133.
https://doi.org/10.1016/s1462-9011(02)00028-x
Blankenship, K. (2020, September 1). FEVE Powder Technology for Weather- and Corrosion-Resistant
Coatings. Paint & Coatings Industry. Retrieved October 6, 2022 from
Draft

PFAS in the metal plating and finishing industry • December 2022 Minnesota Pollution Control Agency
25
https://www.pcimag.com/articles/107819-feve-powder-technology-for-weather--and-
corrosion-resistant-coatings
Blepp, M., Willand, W., & Weber, R. (2017, November). Use of PFOS in chromium plating –
Characterisation of closed-loop systems, use of alternative substances. (UBA-FB 002369/ENG).
German Environment Agency.
https://www.umweltbundesamt.de/sites/default/files/medien/1410/publikationen/2017-11-
01_texte_95-2017_pfos_en_0.pdf
Brendel, S., Fetter, É., Staude, C., Vierke, L., & Biegel-Engler, A. (2018). Short-chain perfluoroalkyl acids:
Environmental concerns and a regulatory strategy under REACH. Environmental Sciences Europe,
30(1), 1–11. https://doi.org/10.1186/s12302-018-0134-4
Brown, A. (2022, June 15). PTFE vs. FR4 PCB laminated materials – cost and performance options. EPEC
Engineered Technologies. Retrieved November 2, 2022 from https://blog.epectec.com/ptfe-vs-
fr4-pcb-laminate-materials-cost-and-performance-options
Cachet, C., & Wiart, R. (1999). Influence of a perfluorinated surfactant on the mechanism of zinc
deposition in acidic electrolytes. Electrochimica Acta, 44(26), 4743–4751.
https://doi.org/10.1016/s0013-4686(99)00223-6
Calafat, A. M., Kato, K., Hubbard, K., Jia, T., Botelho, J. C., & Wong, L. Y. (2019). Legacy and alternative
per- and polyfluoroalkyl substances in the U.S. general population: Paired serum-urine data
from the 2013-2014 National Health and Nutrition Examination Survey. Environment
international, 131, 105048. https://doi.org/10.1016/j.envint.2019.105048
Carlson McCain. (2020, April). P-O-P line etch tank replacement report. Available upon request.
California Environmental Protection Agency. (2006, August). Proposed amendments to the hexavalent
chromium airborne toxic control measure for chrome plating and chromic acid anodizing
operations. California Environmental Protection Agency, Air Resources Board, Stationary Source
Division, Air Quality Measures Branch.
https://ww2.arb.ca.gov/sites/default/files/barcu/regact/chrom06/cpisor.pdf
California Environmental Protection Agency. (2011, May). Investigation and remediation of plating
facilities. California Environmental Protection Agency, Department of Toxic Substances Control.
https://dtsc.ca.gov/wp-content/uploads/sites/31/2018/11/Plating_051611.pdf
Chemguard Specialty Chemicals. (2007). Fluorosurfactants. Chemguard.
https://www.chemguard.com/pdf/specialty-chemical-brochure.pdf
Chemours. (n.d.). The History of Teflon Fluoropolymers. Teflon Brand, Chemours News and Events.
Retrieved October 6, 2022 from https://www.teflon.com/en/news-events/history.
ChemPoint. Have You Used Zonyl® Fluorosurfactants And Repellents In The Past? Fluorosurfactant &
Repellent Transition Guide. Retrieved August 31, 2022, from
https://www.chempoint.com/insights/chemours-zonyl-to-capstone
Cheremisinoff, N. P. (2017). Perfluorinated Chemicals (PFCs): Contaminants of Concern. Wiley.
Draft

PFAS in the metal plating and finishing industry • December 2022 Minnesota Pollution Control Agency
26
Danish Environmental Protection Agency. (2015). Short-chain Polyfluoroalkyl Substances (PFAS): A
literature review of information on human health effects and environmental fate and effect aspects of
short-chain PFAS. Environmental project No. 1707.
https://www2.mst.dk/Udgiv/publications/2015/05/978-87-93352-15-5.pdf
Data Axle. (2022). U.S. Businesses. Retrieved from Reference Solutions database.
http://www.referenceusagov.com/
Deckert, C. A. (1995). Electroless Copper Plating, A Review: Part I. Plating & Surface Finishing, 48–55.
https://www.nmfrc.org/pdf/p0295g.pdf
DuPont. (n.d.). Plating on Plastics. DuPont Electronic Solutions. Retrieved August 31, 2022, from
https://www.dupont.com/electronic-materials/plating-on-plastics.html
Ebdon, P. R. (1985). ‘Niflor’ — A new generation approach to self-lubricating surfaces. Materials &
Design, 6(1), 33–36. https://doi.org/10.1016/0261-3069(85)90088-3
Electro-Coatings. (n.d.). Industrial Copper Plating. Retrieved August 31, 2022, from https://www.electro-
coatings.com/copper-plating.php
Environmental Protection Agency. (2009, September). PFOS chromium electroplater study. U.S.
Environmental Protection Agency – Region 5. https://cswab.org/wp-
content/uploads/2018/09/Chromium-Plating-PFOS-Study-EPA-Region-5-Sept-2009.pdf
Environmental Protection Agency. (2021a, September). Multi-Industry Per- and Polyfluoroalkyl
Substances (PFAS) Study – 2021 Preliminary Report. (EPA 821-R-21-004). U.S. Environmental
Agency, Office of Water. https://www.epa.gov/system/files/documents/2021-09/multi-
industry-pfas-study_preliminary-2021-report_508_2021.09.08.pdf
Environmental Protection Agency. (2021b, September). Preliminary Effluent Guidelines Program Plan 15.
(EPA 821-R-21-003). U.S. Environmental Protection Agency, Office of Water.
https://www.epa.gov/system/files/documents/2021-09/ow-prelim-elg-plan-15_508.pdf
Environmental Protection Agency. (2021c, December 13). PFAS Treatment in Drinking Water and
Wastewater—State of the Science. EPA Research to Support States. Retrieved November 9, 2022
from https://www.epa.gov/research-states/pfas-treatment-drinking-water-and-wastewater-
state-science
European Chemicals Agency. (2021, December). Background Document to the Opinion on the Annex XV
dossier proposing restrictions on undecafluorohexanoic acid (PFHxA), its salts and related
substances. European Chemicals Agency, Committee for Risk Assessment; Committee for Socio-
economic Analysis. https://echa.europa.eu/documents/10162/c41acb41-9ed0-3a35-504f-
255292abdc1f
Ferreira, M.G.S., Zheludkevich, M.L., Yasakau, K.A. (2012). Self-healing nanocoatings for corrosion
control. In Corrosion Protection and Control Using Nanomaterials. Woodhead Publishing.
Finishing.com. (2021, August 12). Chrome plating mist /fume control: PFOS, fume suppressants, surface
tension reducers. Retrieved August 15, 2022, from https://www.finishing.com/325/78.shtml
Draft

PFAS in the metal plating and finishing industry • December 2022 Minnesota Pollution Control Agency
27
Fonnov. (2018, December 24). PVDF Coating vs Powder Coating (Process and Performance). Retrieved
October 6, 2022, from https://www.fonnovaluminium.com/pvdf-vs-powder-coating.html
Gaines, L. G. T. (2022). Historical and current usage of per- and Polyfluoroalkyl Substances (PFAS): A
literature review. American Journal of Industrial Medicine, 1–26.
https://doi.org/10.1002/ajim.23362
Glüge, J., Scheringer, M., Cousins, I., DeWitt, J. C., Goldenman, G., Herzke, D., Lohmann, R., Ng, C., Trier,
X., & Wang, Z. (2020). An overview of the uses of per- and polyfluoroalkyl substances (PFAS).
Environmental Science: Process and Impacts, 20(12), 2345–2373.
https://doi.org/10.31224/osf.io/2eqac
Henkel AG & Co. KGaA. (2017, July). Use of Dischromium tris(chromate) for surface treatment of metals
such as aluminium, steel, zinc, magnesium, titanium, alloys, sealings of anodic films. Analysis of
alternatives submitted to European Chemicals Agency as part of Application for Authorisation.
Retrieved November 10, 2022 from https://echa.europa.eu/documents/10162/e6e945c4-38ed-
48a9-bbd4-6b653b2f8205; https://echa.europa.eu/documents/10162/026452b5-a20e-4a1e-
ad1c-204a48f2c953
Hoke, R. A., Ferrell, B. D., Ryan, T., Sloman, T. L., Green, J. W., Nabb, D. L., Mingoia, R., Buck, R. C., &
Korzeniowski, S. H. (2015). Aquatic hazard, bioaccumulation and screening risk assessment for
6:2 fluorotelomer sulfonate. Chemosphere, 128, 258–265.
https://doi.org/10.1016/j.chemosphere.2015.01.033
Horner, J. (1999). Cyanide Copper Plating. Plating & Surface Finishing, 36–38.
https://www.nmfrc.org/pdf/p1199l.pdf
HRP Associates. (n.d.). PFAS in the Metal Plating Industry: Fact Sheet. Retrieved September 2, 2022 from
https://hrpassociates.com/uploads/files/Metal_Plating_Fact_Sheet.pdf?v=1623863694814
Hughes, A.E. (2018). Conversion Coatings. In Encyclopedia of Interfacial Chemistry. Elsevier.
https://doi.org/10.1016/B978-0-12-409547-2.13441-9
Identification and Listing of Hazardous Waste, 45 F.R. § 261 (1980).
Kissa, E. (2001). Fluorinated surfactants and repellents (Vol. 97, Ser. Surfactant Science). Marcel Dekker.
Knepper, T. P., & Lange, F. T. (2012). Polyfluorinated chemicals and transformation products (Vol. 17,
Ser. The Handbook of Environmental Chemistry). Springer Berlin.
Lassen, C., Brinch, A., & Jensen, A.A. (2017, May). Investigation of sources to PFBS in the environment.
(M-759|2017). Norwegian Environment Agency.
https://www.miljodirektoratet.no/globalassets/publikasjoner/M759/M759.pdf
Lu, M., Cagnetta, G., Zhang, K., Huang, J., & Yu, G. (2017). Mechanochemical mineralization of “very
persistent” fluorocarbon surfactants ‒ 6:2 fluorotelomer sulfonate (6:2Fts) as an example.
Scientific Reports, 7(1), 1–10. https://doi.org/10.1038/s41598-017-17515-7
Makhlouf, A. S. H., & Gajarla, Y. (2019). Advances in smart coatings for magnesium alloys and their
applications in industry. In Advances in Smart Coatings and Thin Films for Future Industrial and
Biomedical Engineering Applications. Elsevier. https://doi.org/10.1016/C2016-0-02150-2
Draft

PFAS in the metal plating and finishing industry • December 2022 Minnesota Pollution Control Agency
28
Makhlouf, A. S. H., & Rodriguez, R. (2019). Bioinspired smart coatings and engineering materials for
industrial and biomedial applications. In Advances in Smart Coatings and Thin Films for Future
Industrial and Biomedical Engineering Applications. Elsevier. https://doi.org/10.1016/C2016-0-
02150-2
Manufacturing Network. (n.d.). What types of anodising are there, and which materials can you
anodise?. Retrieved September 2, 2022, from
https://www.manufacturingnetwork.com/knowledgebase/view/40
Marro, J. B., Okoro, C. A., Obeng, Y. S., & Richardson, K. C. (2017). The Impact of Organic Additives on
Copper Trench Microstructure. Journal of the Electrochemical Society, 164(9). DOI:
10.1149/2.1131707jes
McKeen, L. W. (2016). Binders. In Fluorinated Coatings and Finishes Handbook (Second Edition). Elsevier.
https://doi.org/10.1016/C2014-0-01971-5
Metal Finishing Point Source Category, 40 C.F.R. § 433 (1983).
Michigan Department of Environment, Great Lakes, and Energy. (2020a, June). Targeted and
Nontargeted Analysis of PFAS in Fume Suppressant Products at Chrome Plating Facilities.
https://www.michigan.gov/-
/media/Project/Websites/egle/Documents/Programs/WRD/IPP/pfas-chrome-
plating.pdf?rev=6a8e877adb0e44b6a8c6427b2e4bef66
Michigan Department of Environment, Great Lakes, and Energy. (2020b, August). Identified Industrial
Sources of PFOS to Municipal Wastewater Treatment Plants. https://www.michigan.gov/-
/media/Project/Websites/egle/Documents/Programs/WRD/IPP/pfas-ipp-intiative-identified-
sources.pdf?rev=0f234a957d4947968ba3b44711a93e10
Minevski, Z., Maxey, J., Eylem, C., & Nelson, C. (2002, August 13). Isomolybdate conversion coatings.
(U.S. Patent No. 6432224B1). U.S. Patent and Trademark Office.
https://patents.google.com/patent/US6432224B1/en
Minnesota Department of Health. (2021, December). Toxicological Summary for: Perfluorohexanoate.
https://www.health.state.mn.us/communities/environment/risk/docs/guidance/gw/pfhxa.pdf
Minnesota Department of Health. (2022, February). Air Toxicological Summary for: Perfluorohexanoic
acid (PFHxA).
https://www.health.state.mn.us/communities/environment/risk/docs/guidance/air/pfhxa.pdf
Minnesota Pollution Control Agency. (2017, June). Metal Finishing Pretreatment Facility State Disposal
System General Permit. (MNG120000). https://www.pca.state.mn.us/sites/default/files/wq-
wwprm9-20.pdf
Minnesota Pollution Control Agency. (2022a, March). PFAS Monitoring Plan. (p-gen1-22b).
https://www.pca.state.mn.us/sites/default/files/p-gen1-22b.pdf
Minnesota Pollution Control Agency. (2022b, April). PFAS Air and Deposition Monitoring Report. (tdr-g1-
23). https://www.pca.state.mn.us/sites/default/files/tdr-g1-23.pdf
Draft

PFAS in the metal plating and finishing industry • December 2022 Minnesota Pollution Control Agency
29
Miura, S., & Honma, H. (2003). Advanced copper electroplating for application of Electronics. Surface
and Coatings Technology, 169, 91–95. https://doi.org/10.1016/s0257-8972(03)00165-8
Murphy, J. (2001). Modifying Processing Characteristics: Lubricants, Mould Release Agents, Anti-slip and
Anti-blocking. In Additives for Plastics Handbook. https://doi.org/10.1016/B978-1-85617-370-
4.X5000-3
National Center for Manufacturing Sciences. (2002, April). Recent Alternatives to Chromate for
Aluminum Conversion Coating. (0030RE02).
https://ncms.app.box.com/s/lqtceedvsbf8zvp71i1mixx3u5cgqx5d
National Emission Standards for Chromium Emissions From Hard and Decorative Chromium
Electroplating and Chromium Anodizing Tanks, 40 C.F.R. § 9
(1995). https://www.govinfo.gov/content/pkg/FR-1995-01-25/pdf/95-65.pdf#page=1
National Emission Standards for Chromium Emissions From Hard and Decorative Chromium
Electroplating and Chromium Anodizing Tanks, 40 C.F.R. § 63
(1995). https://www.govinfo.gov/content/pkg/FR-1995-01-25/pdf/95-65.pdf#page=1
National Emission Standards for Hazardous Air Pollutant Emissions: Hard and Decorative Chromium
Electroplating and Chromium Anodizing Tanks; and Steel Pickling—HCl Process Facilities and
Hydrochloric Acid Regeneration Plants, 40 C.F.R. § 63
(2012). https://www.govinfo.gov/content/pkg/FR-2012-09-19/pdf/2012-20642.pdf
Nickel Institute. (2014). Nickel Plating Handbook.
https://nickelinstitute.org/media/2323/nph_141015.pdf
OECD (2022). Per- and Polyfluoroalkyl Substances and Alternatives in Coatings, Paints and Varnishes
(CPVs), Report on the Commercial Availability and Current Uses. OECD Series on Risk
Management, No. 70. Environment, Health and Safety, Environment Directorate, OECD.
https://www.oecd.org/chemicalsafety/portal-perfluorinated-chemicals/per-and-polyfluoroalkyl-
substances-alternatives-in-coatings-paints-varnishes.pdf
Passal, F. (1959). Copper Plating during the Last 50 Years. Plating, 46(6).
https://www.nmfrc.org/pdf/psf2006/100638.pdf
Paulson, K., Matzdorf, C., & Scwartz, S. (2004, March). Final report for the use of wetting agents/fume
suppressants for minimizing the atmospheric emissions from hard chromium electroplating
baths. Naval Facilities Engineering Command, Engineering Service Center.
https://apps.dtic.mil/dtic/tr/fulltext/u2/a423561.pdf
Perfluoroalkyl Sulfonates; Significant New Use Rule, 40 C.F.R. § 721 (2007).
Pewnim, N., & Roy, S. (2015). Effect of fluorosurfactant additive during Cu-Sn codeposition from
Methanesulfonic acid. Journal of The Electrochemical Society, 162(8), 360–363.
https://doi.org/10.1149/2.0551508jes
Pommiers, S., Frayret, J., Castetbon, A., & Potin-Gautier, M. (2014). Alternative conversion coatings to
chromate for the protection of magnesium alloys. Corrosion Science, 84, 135–146.
https://doi.org/10.1016/j.corsci.2014.03.021
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PFAS in the metal plating and finishing industry • December 2022 Minnesota Pollution Control Agency
30
Power Systems Design. (2019, January 22). Fluorinated Resin for Protecting Printed Circuit Boards.
Retrieved November 2, 2022, from https://www.powersystemsdesign.com/articles/fluorinated-
resin-for-protecting-printed-circuit-boards/29/14021
Prevedouros, K., Cousins, I. T., Buck, R. C., & Korzeniowski, S. H. (2005). Sources, Fate and transport of
perfluorocarboxylates. Environmental Science & Technology, 40(1), 32–44.
https://doi.org/10.1021/es0512475
ProPlate. (n.d.). Difference between plating and coating. ProPlate®. Retrieved September 2, 2022, from
https://proplate.com/whats-the-difference-between-plating-and-coating/
Pullara, C., & Gardner, A. (2022, June 18). Chromium Plating. Products Finishing. Retrieved September 2,
2022, from https://www.pfonline.com/articles/chromium-plating(2)
Riedel, T. P., Wallace, M. A., Shields, E. P., Ryan, J. V., Lee, C. W., & Linak, W. P. (2021). Low temperature
thermal treatment of gas-phase fluorotelomer alcohols by calcium oxide. Chemosphere, 272,
129859. https://doi.org/10.1016/j.chemosphere.2021.129859
Ritter, S. K. (2010, February 1). Fluorochemicals Go Short. Chemical & Engineering News, 88(5).
https://cen.acs.org/articles/88/i5/Fluorochemicals-Short.html
Rodowa, A. E., Christie, E., Sedlak, J., Peaslee, G. F., Bogdan, D., DiGuiseppi, B., & Field, J. A. (2020). Field
sampling materials unlikely source of contamination for perfluoroalkyl and polyfluoroalkyl
substances in field samples. Environmental Science & Technology Letters, 7(3), 156–163.
https://doi.org/10.1021/acs.estlett.0c00036
Rudy, S. F. (2022, March 23). Decorative trivalent chromium plating: How goes it? Plating. Retrieved
September 2, 2022, from https://finishingandcoating.com/index.php/plating/1017-decorative-
trivalent-chromium-plating-how-goes-it
Salvatore, D., Mok, K., Garret, K. K., Poudrier, G., Brown, P., Birnbaum, L. S., et al. (2022). Presumptive
Contamination: A New Approach to PFAS Contamination Based on Likely Sources. Environmental
Science & Technology Letters. https://doi.org/10.1021/acs.estlett.2c00502
SAMCO. (2020, December 7). Which Technologies Are the Best at Removing Chromium from Industrial
Water and Wastewater? Retrieved November 9, 2022 from
https://samcotech.com/technologies-best-atremoving-chromium-industrial-water-wastewater/
Schmitz, E. P. S., Quinaia, S. P., Garcia, J. R., de Andrade, C. K., & Lopes, M. C. (2016). Influence of
Commercial Organic Additives on the Nickel Electroplating. International Journal of
Electrochemical Science, 11, 983–
997. http://www.electrochemsci.org/papers/vol11/110200983.pdf
Sharetts Plating Company. (n.d.). Electronics plating. A Comprehensive Guide to Plating for Electronics.
Retrieved September 2, 2022, from https://www.sharrettsplating.com/industries/electronics-
electroplating
Sheng, N., Zhou, X., Zheng, F., Pan, Y., Guo, X., Guo, Y., et al. (2016, December 28). Comparative
hepatotoxicity of 6:2 fluorotelomer carboxylic acid and 6:2 fluorotelomer sulfonic acid, two
fluorinated alternatives to long-chain perfluoroalkyl acids, on adult male mice. Archives of
Toxicology, 91, 2909 – 2919. doi: 10.1007/s00204-016-1917-2
Draft

PFAS in the metal plating and finishing industry • December 2022 Minnesota Pollution Control Agency
31
Snyder, D. (2022, June 18). Choosing and troubleshooting copper electroplating processes. Products
Finishing. Retrieved September 2, 2022, from https://www.pfonline.com/articles/choosing-and-
troubleshooting-copper-electroplating-processes
Solvay. (n.d.). Halar® ECTFE. Retrieved September 2, 2022, from
https://www.solvay.com/en/brands/halar-ectfe
Solvay. (2019, March 19). Solvay develops sustainable Halar ECTFE anti-corrosion coating system.
Retrieved October 6, 2022 from https://www.solvay.com/en/press-release/solvay-develops-
sustainable-halar-ectfe-anti-corrosion-coating-system.
de Souza e Silva, P. T., de Mello, N. T., Menezes Duarte, M. M., Montenegro, M. C., Araújo, A. N., de
Barros Neto, B., & da Silva, V. L. (2006). Extraction and recovery of chromium from
electroplating sludge. Journal of Hazardous Materials, 128(1), 39–43.
https://doi.org/10.1016/j.jhazmat.2005.07.026
Stevenson, M. F. (1994). Anodizing. ASM Handbook, 5, 482–493.
https://doi.org/10.1361/asmhba0001281
Texas Commission on Environmental Quality. (2007, October). Chromium Plating & Anodizing
Operations Using Chromic Acid. Texas Commission on Environmental Quality, Air Permits
Division.
https://www.tceq.texas.gov/assets/public/permitting/air/Guidance/NewSourceReview/emiss_c
alc_chrome.pdf
United Nations Environment Programme. (2010, October). Guidance on alternatives to perfluorooctane
sulfonate and its derivatives. (UNEP/POPS/POPRC.6/13/Add.3). Stockholm Convention on
Persistent Organic Pollutants. http://chm.pops.int/Default.aspx?tabid=783
United Nations Environment Programme. (2021, March). Guidance on best available techniques and
best environmental practices forthe use of perfluoroocatane sulfonic acid (PFOS) and related
chemicals listed under the Stockholm Convention on Persistent Organic Pollutants. Stockholm
Convention.
http://chm.pops.int/implementation/nips/guidance/guidanceonbatbepfortheuseofpfos/tabid/3
170/default.aspx
United States Census Bureau. (2022). Introduction to NAICS. North American Industry Classification
System. Retrieved November 2, 2022 from https://www.census.gov/naics/?99967
Volov, I. (2012). Copper and Copper Alloys: Studies of Additives (Doctoral dissertation, Columbia
University, Ney York, USA). Retrieved from
https://academiccommons.columbia.edu/doi/10.7916/D8X92JCT
Wang, Y., Xu, Y., Lin, S., Liu, W., & Wang, Y. (2022). Recycling of chromium electroplating sludge using
combined calcination-hydrothermal treatment: A risk-reducing strategy for separation of Cr(III)
from solid waste. Surfaces and Interfaces, 29, 101750.
https://doi.org/10.1016/j.surfin.2022.101750
Willand, W., Baron, Y., Blepp, M., Weber, R. (2022, February). Best available techniques for PFOS
substitution in ht esurface treatment of metals and plastics and analysis of alternative
substances to PFOS when used in equipment for chromium plating and plastic etching. Federal
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PFAS in the metal plating and finishing industry • December 2022 Minnesota Pollution Control Agency
32
Environment Agency (UBA).
https://www.umweltbundesamt.de/sites/default/files/medien/1410/publikationen/2022-03-
02_texte_13-2022_best-available-techniques-pfos-substitution.pdf
Zangari, G. (2018). Fundamentals of Electrodeposition. In Encyclopedia of Interfacial Chemistry.
Elsevier.
Zhang, J. X. J., & Hoshino, K. (2018). Fundamentals of nano/microfabrication and scale effect. In
Molecular Sensors and Nanodevices (Second Edition). Elsevier. https://doi.org/10.1016/C2017-0-
02290-5
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