DERR-2024-013251

SITE CHARACTERIZATION WORK PLAN
Redwood Road Dump Pilot Phase Development – VCP Site C121
Approximately 1850 West Indiana Avenue
Salt Lake City, Salt Lake County,Utah
October 17, 2022
Terracon Project No. 61227342_2
Prepared for:
Salt Lake City Corporation
Salt Lake City, Utah
Prepared by:
Terracon Consultants, Inc
Midvale, Utah
Terracon Consultants Inc. 6949 S High Tech Dr, Ste 100 Midvale, UT 84047-3707
P 801-545-8500 F 801-545-8600 terracon.com
October 17, 2022
Utah Department of Environmental Quality
Division of Environmental Response and Remediation
195 North 1950 West
Salt Lake City, Utah 84116
Attn: Mr. Chris Howell
P: [phone]
E:[e-mail]
Re: Site Characterizaiton Work Plan
Redwood Road Dump Pilot Phase Development, VCP Site C121
Approximately 1850 West Indiana Avenue, Salt Lake City, Utah
Terracon Project No. 61227342
Dear Mr. Howell:
Terracon Consultants, Inc. (Terracon) is pleased to submit this Site Characterization Work Plan
on behalf of Salt Lake City Corporation designed to address a request for additional information
pertaining to the above-referenced site.
Sincerely,
Terracon Consultants, Inc.
Nancy Saunders Amy Austin
Project Manager Authorized Project Reviewer
Responsive ■Resourceful ■Reliable
TABLE OF CONTENTS
INTRODUCTION ................................................................................................................ 1
Project Background ................................................................................................... 1
SITE CHARACTERIZATION STRATEGY ......................................................................... 2
Methodology .............................................................................................................. 2
Utility Clearance and Safety ....................................................................................... 3
Soil Investigation Methodology .................................................................................. 3
Groundwater Investigation Methodology .................................................................... 4
Surface Soil Sample Collection .................................................................................. 6
Investigation Derived Wastes..................................................................................... 6
Analytical Program ........................................................................................................... 6
REGULATORY SCREENING LEVELS ............................................................................. 6
QUALITY ASSURANCE / QUALITY CONTROL ............................................................... 7
REPORT ............................................................................................................................ 8
CONTINGENCY PLAN ...................................................................................................... 8
APPENDICES
Appendix A Exhibit 1 – Topographic Map
Exhibit 2 – Proposed Sampling Locations
Appendix B Table B1 – Sampling and Analytical Program
Appendix C Quality Assurance Project Plan
Site Characterization Work Plan – VCP Site C121
Redwood Road Dump Pilot Phase Development ■ Salt Lake City, Utah
October 17, 2022 ■ Terracon Project No. 61227342
Responsive ■Resourceful ■Reliable 1
INTRODUCTION
The site comprises approximately 8 acres, located at approximately 1850 West Indiana
Avenue, Salt Lake City, Utah (Exhibit 1; Appendix A). Salt Lake City Corporation (SLCC)
seeks to redevelop the property as a tiny home development to serve the City’s unsheltered
population. This would consist of numerous tiny homes, a medical clinic, and two additional
public buildings. Because of the documented environmental impacts identified at the Site, the
Client will need to take specific measures to address exposure risks for the proposed future
development.
SLCC has enrolled the Site in Utah Division of Environmental Response and Remediation’s
(DERR’s) Voluntary Cleanup Program (VCP). The site was evaluated and accepted into the
VCP and is designated by DERR as VCP Site C121.
Project Background
The Site was formerly included in the Redwood Road Dump CERCLA facility (Facility ID
UTD980961502); however, the current Pilot Phase development is comprised of 8 acres
which are situated east of the area that was landfilled (Exhibit 2; Appendix A).
Previous investigations of the larger parent parcel and the current Pilot Phase portion have
indicated that there have been minimal impacts from landfilling and other industrial uses of
the Site and nearby properties. Soil impacts have not been observed, with the exception of
minor amounts of debris in the upper 5 feet in soils in some locations. Groundwater impacts
site-wide appear limited to dissolved arsenic. In addition, a sample from one groundwater
monitoring well at the site reported perfluoroalkyl substances (PFAS) compounds in excess
of federal health advisories. The source of these impacts is likely the landfill on the parent
parcel which appears to be upgradient of the Site.
Chloroform may pose a potential for vapor intrusion into future buildings on the northern
portion of the Site based on the soil gas analytical results. Methane appears to be present at
elevated levels farther west of the Site, on the parent parcel. The source of the methane was
not specifically identified, but likely includes both landfill materials and natural sources.
In correspondence dated September 1, 2022, the DERR has indicated that additional site
characterization is needed to provide data on current site conditions, to characterize the
nature of the overlying non-native fill material, and to evaluate potential impacts from the east-
adjoining Alvie Carter Trust (ACT) property junk yard, some of which had encroached onto
the site.
Site Characterization Work Plan – VCP Site C121
Redwood Road Dump Pilot Phase Development ■ Salt Lake City, Utah
October 17, 2022 ■ Terracon Project No. 61227342
Responsive ■Resourceful ■Reliable 2
SITE CHARACTERIZATION STRATEGY
On behalf of SLCC, Terracon has developed this Site Characterization Work Plan (SCWP)
outlining the proposed approach to complete the additional investigations requested by DERR
in their letter to SLCC dated September 1, 2022.The scope of work is designed to provide
data necessary to more fully characterize the nature and extent of any impacts as well as data
needs that were identified based on the proposed development strategy. The developer
intends to remove all fill from the Pilot Phase area, which is unsuitable for use as building
substrate. The fill material, where present, ranges in thickness from approximately one foot
to five feet thick. Depending on the character of the fill material, it will be transferred to the
western side of the parent parcel, where the large landfill pile is located. This material was
not characterized in previous investigations and the feasibility of this approach needs to be
evaluated.
Previous investigations included sampling soil gas for volatile organic compounds (VOCs) as
well as methane. Sampling indicated a soil vapor intrusion condition may exist in portions of
the Pilot Phase area and methane was detected in soil gas farther west on the parent parcel.
The developer intends to incorporate a vapor intrusion mitigation system into occupied
buildings in order to address this potential condition. As such, additional soil gas sampling is
not proposed for this Site Characterization.
This Site Characterization Work Plan addresses the following tasks:
n Sampling of fill materials not previously sampled;
n An evaluation of potential impacts originating from the adjoining Alvie Carter Trust
(ACT) property on the east side of the site, including an apparent burn pit discovered
within the Site boundary;
n Installation of two new monitoring wells;
n Groundwater sampling from all five monitoring wells at the Site and a water level
survey; and
n Collection of surface soils from the section of the North Ditch that crosses the Site.
Methodology
Standard Operating Procedures (SOPs) to be followed during the implementation of the Site
characterization field work are described in detail in the Quality Assurance Project Plan
(Appendix C) and are summarized in the following sections.Exhibit 2; Appendix A shows
the locations of proposed sampling points.Table 1; Appendix B, presents the sample
strategy, rationale, analyses and analytical methods.
Site Characterization Work Plan – VCP Site C121
Redwood Road Dump Pilot Phase Development ■ Salt Lake City, Utah
October 17, 2022 ■ Terracon Project No. 61227342
Responsive ■Resourceful ■Reliable 3
Utility Clearance and Safety
Following receipt of a notice to proceed and no later than 48 hours prior to intrusive activities,
the selected boring and excavation subcontractors will contact the public utility locating
service (Blue Stakes) to arrange for underground utility locates at the site. Terracon will
subcontract with a private utility locating service to clear the monitoring well and test pit
locations.
Terracon has a 100% commitment to the safety of all its employees. As such, and in
accordance with our Incident and Injury Free® safety culture, Terracon will develop a safety
plan to be used by our personnel during field services. Prior to commencement of on-site
activities, Terracon will hold a meeting to review health and safety needs for this specific
project. At this time, we anticipate performing fieldwork in a USEPA Level D work uniform
consisting of hard hats, safety glasses, protective gloves, and steel-toed boots.
Soil Investigation Methodology
The excavation of test pits using a mini-excavator will be used to evaluate soils and collect
sub-surface samples. Seven test pits will be advanced in areas where fill has previously been
encountered for the purpose of observing the nature of the materials and to collect samples
for laboratory analyses (Test Pits TP-33 through TP-39). An additional three test pits will be
excavated to investigate the ACT area and burn pit (Test Pits TP-40 through TP-42).
Soils from the test pits will be logged to document general lithology, color, and the presence
or absence of fill and debris. Soils will be field screened using a photoionization detector (PID)
to qualitatively evaluate the presence of volatile organic compounds (VOCs).
Sampling equipment will be cleaned using an Alconoxâ wash and potable water before
beginning the project and before collecting each soil sample. The samples will be placed in
laboratory-prepared containers, labeled, and placed on ice in a cooler. The sample coolers
and completed chain-of-custody forms will be relinquished the analytical laboratory for
analysis on a standard turnaround time.
Test Pit Samples for Fill Investigation
One soil sample will be collected from each test pit designated to investigate fill material (TP-
33 through TP-39). Samples to be submitted for VOC analysis will be grab samples from the
6-inch interval displaying the greatest impacts, such as positive PID readings and/or staining.
If evidence of impacts is not observed, the grab samples will be collected from the 6-inch
interval in the approximate center of the vertical profile. Samples for non-volatile analytes
(metals, SVOCs, PCBs, dioxins/furans) will be composited from the material encountered
from the surface to the total depth of the test pit using a hand trowel. In addition, TP-37,
positioned just north of the asphalt pad used for green waste staging, will also be used to
Site Characterization Work Plan – VCP Site C121
Redwood Road Dump Pilot Phase Development ■ Salt Lake City, Utah
October 17, 2022 ■ Terracon Project No. 61227342
Responsive ■Resourceful ■Reliable 4
investigate potential impacts from Salt Lake City’s occasional staging of household waste from
clearing homeless camps.
A second sample from each test pit location will be collected from the underlying native
material. This sample will be placed on hold at the laboratory until the results of the primary
fill sample are received. It will be submitted for selected analysis if impacts above regulatory
levels are reported in the fill material.
Test Pit Samples for ACT Investigation
Two soil samples will be collected from each test pit designated to investigate the ACT burn
pit that has encroached on to the Site (TP-40 through TP-42): one composite sample will be
collected from the fill material and a second sample will be collected from underlying native
soils.
Materials excavated from the test pits will be examined for the presence of potential Asbestos-
Containing Building Materials (ACBM) by a Certified Asbestos Building Inspector as required
by Utah Division of Air Quality rules at UAC R307-801. If suspect materials are observed, a
sample will be collected of each material type to determine asbestos content. The samples
will be submitted to a Utah-certified laboratory for analysis by polarized light microscopy (PLM),
using EPA Method 600/R-93/116.
Groundwater Investigation Methodology
The groundwater sampling program includes the installation of two new monitoring wells,
MW04 and MW05, which will create a network of five wells. The five wells will be surveyed
by a licensed surveyor and water levels measurements will be collected in order to calculate
the direction of groundwater flow in the shallow water table. One groundwater sample will be
collected from each well.
New Monitoring Well Installation
Soil borings for the two new monitoring wells will be advanced with direct push (“Geoprobe”)
drilling equipment outfitted with 3.75-inch rods to allow for the construction of 2-inch-diameter
monitoring wells. The mechanized drilling services will be performed by a Utah-licensed well
driller; Terracon environmental personnel will select the boring locations, visually observe the
drilling activities, and log the soil borings. Soil samples for laboratory analysis will not be
collected; however, soils will be continuously cored in 5-foot intervals and observed to
document subsurface soil types, color, relative moisture content, presence or absence of fill,
and sensory evidence of environmental impacts. The soil cores will be field screened using
sensory methods, and a PID to qualitatively evaluate the presence of VOCs.
At each location, the borings will be converted to groundwater monitoring wells (MW-04, and
MW-05). The monitoring wells will be installed according to the following general procedures:
Site Characterization Work Plan – VCP Site C121
Redwood Road Dump Pilot Phase Development ■ Salt Lake City, Utah
October 17, 2022 ■ Terracon Project No. 61227342
Responsive ■Resourceful ■Reliable 5
n Borings will be advanced to a total depth between 13 to 16.5 feet below
ground surface (bgs);
n Installation of 10 feet of 2-inch diameter, 0.010-inch machine slotted
polyvinyl chloride (PVC) well screen with a threaded bottom cap;
n Installation of 2-inch diameter, threaded, flush-joint PVC riser pipe to
approximately 2 feet above the surface;
n Addition of pre-sieved 20/40 grade silica sand for annular sand pack
around the screened interval from the bottom of the boring to 2 feet above
the top of the screen;
n Placement of 2 feet of hydrated bentonite pellets above the sand pack;
and;
n Addition of cement/bentonite slurry to the surface.
Monitoring Well Development
A minimum of 24 hours after the new wells are constructed, they will be developed by bailing
with new disposable bailers to remove fine grained sediments from the sand pack and well
screen in order to allow the infiltration of formation water. Approximately five casing volumes
of water will be removed from each well.
Water Level Survey
The top of the PVC casing in each of the five monitoring wells will be surveyed by a licensed
surveyor. Depth-to-groundwater will be measured in each of the monitoring wells on the same
day and the site-specific groundwater gradient will be calculated using the well casing
elevations and depth-to-groundwater measurements.
Groundwater Sample Collection
The three existing and two new wells will be sampled using low-flow sampling methods as
described in the QAPP (SOP 12A). In general, the wells will be purged using a low-flow
peristaltic pump with the inlet placed within the top foot of the water column. The peristaltic
pump will be set to pump water at a rate of 200 milliliters per minute (mL/min) or less. The
wells will be purged until groundwater quality parameters of pH, temperature, conductivity,
dissolved oxygen, and turbidity stabilize to within 10% over three consecutive readings.
In some cases, it may not be possible to achieve stabilization of the above-listed water quality
parameters. In those cases, the well will be purged until either three casing volumes are
removed; or the well pumps dry. If the well purges dry before water quality parameters
stabilize, the well will be allowed to recharge and a sample will be directly collected from the
well using the low-flow method.
Site Characterization Work Plan – VCP Site C121
Redwood Road Dump Pilot Phase Development ■ Salt Lake City, Utah
October 17, 2022 ■ Terracon Project No. 61227342
Responsive ■Resourceful ■Reliable 6
Once the sampling criteria has been met, the sample will be collected using the well purging
pump already in place. The laboratory-supplied sample containers will be filled out of the pump
discharge line maintaining the low-flow setting.
Samples collected for analysis of PFAS compounds require special handling procedures, as
detailed in SOP 13 included in the QAPP. In general, Terracon will employ the “Clean Hands
– Dirty Hands” protocol, developed by the US EPA for sampling low level metals and can be
used for other contaminants that are analyzed in the parts per trillion range. Samples for
analysis of metals will be filtered through an in-line, disposable, 0.45-micron pore filter.
Surface Soil Sample Collection
A total of two soil samples will be collected of the shallow soil / sediments in the North Ditch
at two locations where it crosses the site (ND-4 and ND-5). Shallow soil samples will be
collected from the sediments / surficial soils from 0 to 4 inches below the surface using a hand
trowel.
Investigation Derived Wastes
Soils excavated from the test pits will be returned to the pit from which they were removed.
Soil cuttings from well installation will be scattered in the vicinity of the boring that they came
from. Groundwater from well development and sampling will be thin spread in the vicinity of
the sampled well. If the well is located near pavement or other hard surface, the purge water
will be spread on that surface.
ANALYTICAL PROGRAM
Table 1, Appendix B, presents the proposed sample analyses for this Site Characterization.
REGULATORY SCREENING LEVELS
The laboratory analytical results will be compared to current Environmental Protection Agency
(EPA) regulatory guidance and standards.
Soil sample results will be compared to the most recently published EPA Regional Screening
Levels (RSL) for residential and industrial use scenarios.
Groundwater sample results will be compared to the Federal Maximum Contaminant Levels
(MCLs) for drinking water. If an MCL is not established for an analyte, the results will be
screened against the EPA RSL for tapwater. Note that MCLs have been published for five
PFAS compounds.
Site Characterization Work Plan – VCP Site C121
Redwood Road Dump Pilot Phase Development ■ Salt Lake City, Utah
October 17, 2022 ■ Terracon Project No. 61227342
Responsive ■Resourceful ■Reliable 7
QUALITY ASSURANCE / QUALITY CONTROL
This Work Plan includes the collection of thirteen (13) fill samples, three (3) shallow soil
samples, and five (5) groundwater samples. In addition, seven (7) native soil samples of will
be collected and held at the laboratory pending results of the fill sample analyses. All sample
analyses will be conducted by Chemtech Ford Analytical Laboratories under a Level 3 QC
Program that includes a laboratory control sample, a matrix spike and matrix spike duplicate
requested to be performed on one of the project samples, a laboratory method blank, a
narrative report of QC results and any corrective actions required.
Field duplicates will be collected at rate of 10 percent of soil and groundwater samples. Up
to three field duplicate soil samples and one field duplicate groundwater sample will be
selected at random.
Equipment blank samples will be collected at a rate of 10 percent for groundwater samples
collected for PFAS analysis. One equipment blank groundwater sample will be collected.
Field blank samples will be collected at a rate of 10 percent for groundwater samples collected
for PFAS analysis. One field blank groundwater sample will be collected.
Trip blank samples will be collected at a rate of 10 percent for groundwater samples collected
for VOC and PFAS analyses.
One trip blank groundwater sample will be collected and included in the sample transport for
VOC samples. One field blank groundwater sample will be collected and included in the
sample transport for PFAS samples.
UDEQ split soil samples may be collected of all soil and groundwater samples and submitted
for laboratory analyses at their discretion. UDEQ split samples will be collected and submitted
to a second independent Utah-certified analytical laboratory for the same analyses as the
original samples, using the same analytical method and QC procedures as the laboratory
analyzing the soil and groundwater samples. The UDEQ split samples will be coordinated
with, and collected by, the field team collecting the samples to maintain consistency of
sampling procedures. UDEQ split sample collection will be observed by a UDEQ
representative and the sample custody will be transferred to the UDEQ representative to
complete laboratory chain-of-custody forms and deliver to the second, independent Utah-
certified analytical laboratory.
Soil boring logs, groundwater sample forms, and field notes will be completed during the field
work. All work will be conducted following Terracon’s Standard Operating Procedures
included in the QAPP in Appendix C.
Site Characterization Work Plan – VCP Site C121
Redwood Road Dump Pilot Phase Development ■ Salt Lake City, Utah
October 17, 2022 ■ Terracon Project No. 61227342
Responsive ■Resourceful ■Reliable 8
Site-specific conditions may require an adjustment to the field program and a deviation from
this Work Plan to accommodate site-specific needs. If an adjustment or deviation becomes
necessary, the activities and reasoning will be documented and implemented. The UDEQ
Project Manager will be notified if the adjustment is determined to be a significant one. Such
adjustments (for example, adjustments in sampling locations) may introduce some degree of
variability, which will be reconciled with project information by evaluating whether contaminant
levels may be underestimated or overestimated, and how this may affect eventual site
management or cleanup approaches, if applicable.
REPORT
A report will be prepared and submitted within 30 days of receipt of laboratory analytical data.
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. The report will
include, at a minimum, site observations (e.g. subsurface lithology, distribution of impacts,
etc., boring and test pit logs, groundwater sampling forms), comprehensive analytical results
and QA/QC tables, any deviations from this Work Plan, and sample location maps.
The report will be submitted to the DERR for review and acceptance.
CONTINGENCY PLAN
In the event that unidentified environmental concerns are encountered during the site
investigation, work will stop in the area of the concern until SLCC, Terracon, and regulatory
agency personnel determine an appropriate course of action.
APPENDIX A
Exhibits
TOPOGRAPHIC MAP
Redwood Road Dump Pilot Phase VCP Site
1850 West Indiana Avenue
Salt Lake City, UT
TOPOGRAPHIC MAP IMAGE COURTESY OF THE U.S. GEOLOGICAL SURVEY
QUADRANGLES INCLUDE: SALT LAKE CITY NORTH, UT (1/1/1998) and SALT LAKE CITY SOUTH, UT (1/1/1999).
6949 S High Tech Dr Ste 100
Midvale, UT 84047-3707
61217342
Project Manager:
Drawn by:
Checked by:
Approved by:
NS
AA
AA
1”=2,000’
Ex 1
9/22
Project No.
Scale:
File Name:
Date:
1
ExhibitNS
APPROXIMATE
SITE BOUNDARY
APPENDIX B
Tables
Sample ID Type and
Designation
Purpose
REC/Site Concern
Advancement
Method Estimated Depth No. of Soil Samples
per location Soil Analytical1
Water
Sample?
(y/n)
Groundwater
Analytical1
TP-33 Fill Material
Sample
Evaluate Fill material to be
moved west of site Mini Excavator
Composite of
observed fill profile:
approximately 0-5 feet
2: one Fill, one
native.
Hold native at lab
VOCs, RCRA Metals,
SVOCs N n/a
TP-34 Fill Material
Sample
Evaluate Fill material to be
moved west of site Mini Excavator
Composite of
observed fill profile:
approximately 0-5 feet
2: one Fill, one
native.
Hold native at lab
VOCs, RCRA Metals,
SVOCs, PCBs N n/a
TP-35 Fill Material
Sample
Evaluate Fill material to be
moved west of site Mini Excavator
Composite of
observed fill profile:
approximately 0-5 feet
2: one Fill, one
native.
Hold native at lab
VOCs, RCRA Metals,
SVOCs, PCBs N n/a
TP-36 Fill Material
Sample
Evaluate Fill material to be
moved west of site Mini Excavator
Composite of
observed fill profile:
approximately 0-5 feet
2: one Fill, one
native.
Hold native at lab
VOCs, RCRA Metals,
SVOCs N n/a
TP-37 Fill Material
Sample
Evaluate Fill material to be
moved west of site; also
evaluate potential impacts
from homeless camp
cleanouts
Mini Excavator
Composite of
observed fill profile:
approximately 0-5 feet
3: one shallow soil,
one fill, one native.
Hold native at lab
VOCs, RCRA Metals,
SVOCs, PCBs N n/a
TP-38 Fill Material
Sample
Evaluate Fill material to be
moved west of site Mini Excavator
Composite of
observed fill profile:
approximately 0-5 feet
2: one Fill, one
native.
Hold native at lab
VOCs, RCRA Metals,
SVOCs, PCBs N n/a
TP-39 Fill Material
Sample
Evaluate Fill material to be
moved west of site Mini Excavator
Composite of
observed fill profile:
approximately 0-5 feet
2: one Fill, one
native.
Hold native at lab
VOCs, RCRA Metals,
SVOCs N n/a
Fill
Table 1 - Sampling and Analytical Program
Redwood Road Dump Pilot Phase VCP Site C121
1850 West Indiana Ave, Salt Lake City, Utah
Terracon Project No. 61227342
Page 1 of 2
Sample ID Type and
Designation
Purpose
REC/Site Concern
Advancement
Method Estimated Depth No. of Soil Samples
per location Soil Analytical1
Water
Sample?
(y/n)
Groundwater
Analytical1
Table 1 - Sampling and Analytical Program
Redwood Road Dump Pilot Phase VCP Site C121
1850 West Indiana Ave, Salt Lake City, Utah
Terracon Project No. 61227342
TP-40
Fill Material
Sample &
Native Soil
Sample
Evaluate Fill and underlying
native adjacent to Alvie
Carter Property
Mini Excavator
Composite of fill
material( 0-24");
Native just below Fill
2
VOCs, RCRA Metals,
SVOCs, PCBs, ACBM if
suspect material
observed
N n/a
TP-41
Fill Material
Sample &
Native Soil
Sample
Evaluate Fill and underlying
native adjacent to Alvie
Carter Property and in burn
pit
Mini Excavator
Composite of fill
material( 0-24");
Native just below Fill
2
VOCs, RCRA Metals,
SVOCs, Dioxins/furans,
ACBM if suspect
material observed
N n/a
TP-42
Fill Material
Sample &
Native Soil
Sample
Evaluate Fill and underlying
native adjacent to Alvie
Carter Property
Mini Excavator
Composite of fill
material( 0-24");
Native just below Fill
2
VOCs, RCRA Metals,
SVOCss, PCBs, ACBM if
suspect material
observed
N n/a
ND-4 Surface Soil Evaluate surface soils and
sediments in North Ditch Hand trowel 0-4"1 VOCs, RCRA Metals,
SVOCs N n/a
ND-5 Surface Soil Evaluate surface soils and
sediments in North Ditch Hand trowel 0-4"1 VOCs, RCRA Metals,
SVOCs N n/a
MW-01 Groundwater Evaluate current
groundwater conditions
2" Monitoring
Well n/a 0 n/a Y
VOCs, RCRA Metals*,
SVOCs, PFAS, 1,4-
dioxane, TDS
MW-02 Groundwater Evaluate current
groundwater conditions
2" Monitoring
Well n/a 0 n/a Y
VOCs, RCRA Metals*,
SVOCs, PFAS, 1,4-
dioxane, TDS
MW-03 Groundwater Evaluate current
groundwater conditions
2" Monitoring
Well n/a 0 n/a Y
VOCs, RCRA Metals*,
SVOCs, PFAS, 1,4-
dioxane, TDS
MW-04 Groundwater Evaluate upgradient
groundwater conditions
2" Monitoring
Well n/a 0 n/a Y
VOCs, RCRA Metals*,
SVOCs, PFAS, 1,4-
dioxane, TDS
MW-05 Groundwater
Evaluate groundwater
adjacent to Alvie Carter
property
2" Monitoring
Well n/a 0 n/a Y
VOCs, RCRA Metals*,
SVOCs, PFAS, 1,4-
dioxane, TDS
Notes:n/a - not applicable.
1Analytical Methods:
VOCs - Volatile organic compounds by EPA 8260. RCRA Metals - Arsenic, Barium, Cadmium, Chromium, Lead, Mercury, Selenium, and Silver. *Dissolved.
SVOCs - Semi-volatile Aromatic Hydrocarbons by EPA Method 8270 SIM. PCBs - Polychlorinated Biphenols by EPA Method 8082
Dioxins / furans by EPA Method 8290. PFAS - perfluoroalkyl substances by EPA Method Modified 537. 1,4 Dioxane by EPA Method 8260 SIM
TDS-Total dissolved solids by EPA SM 2540 C; ACBM - Asbestos-containing building materials by EPA Method 600/R-93/116
Groundwater Assessment
North Ditch
ACT / Burn Pit
Page 2 of 2
APPENDIX C
Terracon Quality Assurance Project Plan
QUALITY ASSURANCE PROJECT PLAN
Redwood Road Dump Pilot Phase Project
VCP Site C121
Salt Lake City, Utah
October 17, 2022
Terracon Project No. 61227342
Prepared for:
Salt Lake City Corporation, Department of Sustainability
Prepared by:
Terracon Consultants, Inc.
Salt Lake City, Utah
Quality Assurance Project Plan
Redwood Road Dump Pilot Phase VCP ■ Salt Lake City, Utah
October 17, 2022 ■ Terracon Project No. 61227342
Responsive ■ Resourceful ■ Reliable 1
GROUP A PROJECT MANAGEMENT
A1 Title and Approval Sheet
Project Title:
Redwood Road Dump Pilot Phase Project Quality Assurance Project Plan
VCP Site C121
Salt Lake City, Utah
Terracon Consultant Project Manager
Signature Date
Nancy Saunders.
Printed Name
Terracon Consultant Authorized Project Reviewer
Signature Date
Amy Austin
Printed Name
N:\Projects\2022\61227342\Working Files\DRAFTS (Proposal-Reports-Communications)\61227342 Redwood Road Dump Pilot Ph QAPP.docx
Quality Assurance Project Plan
Redwood Road Dump Pilot Phase VCP ■ Salt Lake City, Utah
October 17, 2022 ■ Terracon Project No. 61227342
Responsive ■ Resourceful ■ Reliable 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 ............................................................................................................... 5
A4 Project/Task Organization ............................................................................................... 6
A5 Problem Definition/Background ....................................................................................... 8
A5.1 Regulatory Standards and Criteria...................................................................... 9
A6 Project / Task Description and Schedule ........................................................................ 9
A7 Quality Objectives and Criteria for Measurement Data .................................................. 10
A7.1 Data Quality Objectives .................................................................................... 10
A7.2 Measurement Performance Criteria .................................................................. 10
A8 Special Training Requirements ..................................................................................... 12
A9 Documentation and Records......................................................................................... 12
GROUP B MEASUREMENT/DATA ACQUISITION ....................................................................... 13
B1 Sampling Process Design ............................................................................................. 13
B2 Sampling Methods Requirements ................................................................................. 13
B3 Sample Handling, Preservation and Custody Requirements .......................................... 14
B4 Analytical Methods Requirements ................................................................................. 14
B5 Quality Control Requirements ....................................................................................... 14
B5.1 Definitive Data ................................................................................................. 14
B5.2 Non-definitive data ........................................................................................... 17
B6 Equipment Testing, Inspection, and Maintenance Requirements ................................... 17
B7 Instrument/Equipment Calibration and Frequency ......................................................... 17
B7.1 Field Instruments ............................................................................................. 17
B7.2 Laboratory Instruments .................................................................................... 18
B8 Inspection/Acceptance Requirements for Supplies and Consumables ........................... 18
B9 Data Acquisition of Non-direct Measurements ............................................................... 18
B10 Data Management ........................................................................................................ 19
GROUP C ASSESSMENT/OVERSIGHT ....................................................................................... 19
C1 Assessment Activities ................................................................................................... 19
C2 Reports to Management ............................................................................................... 21
GROUP D DATA VALIDATION AND USABILITY ......................................................................... 21
D1 Data Review ................................................................................................................. 21
D2 Validation and Verification Methods .............................................................................. 21
D3 Reconciliation with User Requirements ......................................................................... 22
GROUP E REFERENCES ............................................................................................................. 22
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EXHIBIT
Exhibit 1:Project Boundary
TABLES
Table 1:Measurement Performance Criteria in Terms of Data Quality Indicators
Table 2:Method Summary
Table 3:Data Validation and Verification Methods
APPENDICES
Appendix A: Standard Operating Procedures and Field Forms
Appendix B: Laboratory Quality Assurance Manuals
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A2.1 Acronym List
CERCLA Comprehensive Environmental Response, Compensation, and Liability Act, as Amended
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 ESC Laboratories
HASP Health and Safety Plan
LCS Laboratory Control Sample
LFB Laboratory Fortified Blank
LIMS Laboratory Information Management System
LRL Laboratory Reporting Limit
MCL Maximum Contaminant Level
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 micrograms per liter (or parts per billion)
MS Matrix Spike
MSD Matrix Spike Duplicate
NELAP National Environmental Laboratory Accreditation Program
OSHA Occupational Safety and Health Act
PARCCS Precision, Accuracy, Representativeness, Completeness, Comparability, and Sensitivity
ppb parts per billion (in µg/kg or µg/L)
ppm parts per million (in mg/kg or mg/L)
PR Percent Recovery
PS Performance Standard
QA Quality Assurance
QAPP Quality Assurance Project Plan
QC Quality Control
RSL Regional Screening Level
SAP Sampling and Analysis Plan
SLCC Salt Lake City Corporation
TOC Table of Contents
UDEQ Utah Department of Environmental Quality
US EPA United States Environmental Protection Agency
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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]
Chris Howell, P.G.
Utah Department of Environmental Quality
Division of Environmental Response and Remediation
P.O. Box 144840
Salt Lake City, UT 84114-4840
(801) 385-391-8140
Email:[e-mail]
Nancy Saunders
Consultant Project Manager
Terracon Consultants, Inc.
6949 South High Tech Drive
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]
Environmental Laboratory: Chemtech-Ford Analytical
Jen Osborne, Laboratory Quality Assurance Director
9632 500 West
Sandy, Utah 84070
Phone: [phone]
Email:[e-mail]
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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 Redwood Road Dump Pilot Phase Project. The property is
enrolled in the Utah Department of Environmental Quality (UDEQ) Voluntary Cleanup Program
and is registered as VCP Site C121. Following is a brief description and identification of key
personnel involved in conducting investigations at this site.
Salt Lake City Corporation Project Manager
The property is owned by the Salt Lake City Corporation (SLCC). 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 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 (SCWPs) 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:
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Nancy Saunders
Consultant Project Manager
Terracon Consultants, Inc.
6949 South High Tech Drive
Midvale, UT 84047
Phone: [phone]
Email:[e-mail]
Consultant QA/QC Officer
The Consultant QA/QC Officer for this project will act 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:
Chris Howell, P.G.
Utah Department of Environmental Quality
Division of Environmental Response and Remediation
P.O. Box 144840
Salt Lake City, UT 84114-4840
(801) 385-391-8140
Email:[e-mail]
Environmental Laboratory: Chemtech Ford Analytical Laboratories
Samples of environmental media that are collected during the course of this project will be
analyzed by Chemtech Ford Analytical Laboratories. Chemtech Ford is responsible for providing
reliable and high-quality analytical data, using the quality systems detailed in its Quality Manual
(Appendix B). The Quality Assurance Director for Chemtech Ford is responsible for managing
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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:
Chemtech-Ford Inc.
Jenn Osborn, Laboratory Director of Quality
9632 South 500 West
Sandy, Utah 84070
Phone: [phone]
Email:[e-mail]
Environmental Laboratory: Eurofins EMLab P&K Analytical Testing Laboratories (EMLab P&K)
Samples of potential asbestos-containing building materials (ACBM), if collected, will be analyzed
by EMLab P&K. A copy of EMLab P&K’s Quality Assurance Manual is provided in Appendix B.
The Environmental Laboratory and Quality Assurance Director is:
Eurofins EMLab P&K Analytical Testing Laboratories
Claudia Palermo, Laboratory Quality Manager
1501 W. Knudsen Drive
Phoenix, Arizona 85027
Phone: [phone] x 102
Email:[e-mail]
A5 Problem Definition/Background
The site is located at approximately 1850 West Indiana Avenue, Salt Lake City, Utah (Exhibit 1).
It was formerly included in the Redwood Road Dump CERCLA facility (Facility ID
UTD980961502); however, the current Pilot Phase Project area is comprised of 8 acres which
are situated east of the area that was formerly landfilled.
Previous investigations of the larger parent parcel and the current Pilot Phase portion have
indicated there have been minimal impacts from landfilling and other industrial uses of the site
and nearby properties. Soil impacts have not been observed, with the exception of minor amounts
of debris in the upper 5 feet in soils in some locations. Groundwater impacts appear limited to
dissolved arsenic. In addition, a sample from one groundwater monitoring well at the site reported
perfluorooctanesulfonic acid (PFOS) in excess of the health advisory level of 70 ng/L. The source
of these impacts is likely the landfill on the parent parcel which appears to be upgradient of the
Site.
Chloroform may pose a potential for vapor intrusion into future buildings on the northern portion
of the Site based on soil gas analytical results. Additionally, methane appears to be present at
elevated levels farther west of the Site, on the parent parcel. The source of the methane was not
specifically identified, but likely includes both landfill materials and natural sources.
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The UDEQ VCP has indicated that additional site characterization is needed to provide data on
current site conditions, to characterize the nature of the overlying fill material so that proper
disposal methods during site development can be determined, and to evaluate impacts from the
east-adjoining Alvie Carter Trust (ACT) property junk yard observed during a site visit. In
correspondence dated September 1, 2022, the DERR requested a Site Characterization
Workplan (SCWP) for additional investigation and a QAPP to guide all investigations at the Site.
A5.1 Regulatory Standards and Criteria
Regulatory standards will be the current Environmental Protection Agency (EPA) regulatory
guidance and standards.
n Soil sample results will be compared to the most recently published EPA Regional
Screening Levels (RSL) for residential and industrial use scenarios.
n Groundwater sample results will be compared to the most recently published EPA
Maximum Contaminant Levels (MCLs) for drinking water. If an MCL is not established
for an analyte, the results will be screened against the EPA RSL for tapwater. Note
that MCLs have been published for five PFAS compounds.
n Samples of suspect ACBM will be analyzed and compared to regulatory guidance and
standards at U.S. EPA 40 CFR Part 60 Subpart M (Asbestos NESHAP) and Utah
Department of Environmental Quality, Division of Air Quality standards at UAC R307-
801.
A6 Project / Task Description and Schedule
The objectives of sampling at the Site are to:
n Identify and document concentrations of COCs in groundwater and, if COC
concentrations are identified in groundwater that exceed Cleanup Levels, properly
address management of groundwater.
n Evaluate the potential for other COCs in the ACT area where junk yard debris has
encroached onto the site and evidence of burning was recently observed. Further
characterization of soils and groundwater in this area is warranted.
n Document concentrations of COCs in soil. Where present, proper handling of
those soils will be specified in the RAP.
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A Site Characterization Work Plan (SCWP) will be developed for the Phase II Assessment to be
conducted on the site. The SCWP will detail the contaminants of concern, sampling locations,
and sampling rationale.
The SCWP will include 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) (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.
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.
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.
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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 on the basis of relative percent difference (RPD)
as a measure of reproducibility between LCS/LCSD pairs and 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, LCS/LCSD, and MS/MSD
summaries provided by the laboratory. Method blank analyte concentrations are expected to be
below laboratory reporting limits, while 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 through
the use of 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. Completeness is the ratio of valid measurements to
the number of planned measurements, expressed as a percentage, and the completeness goal
for the project is 90%. The level of 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 EPA Superfund Data Categories (EPA; September 1993). Analytical results will be evaluated
using current EPA RSLs, MCLs, and VISLs, as appropriate. Results for asbestos samples, if
collected, will be compared to EPA 40 CFR Part 60 Subpart M (Asbestos NESHAP) and Utah
Department of Environmental Quality, Division of Air Quality standards (UAC R307-801). As
such, the level of data sensitivity is required to result in laboratory reporting limits (practical
quantitation limits or PQLs) that are below the regulatory screening levels listed above.
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 laboratory. The laboratory, which is associated with
the National Environmental Laboratory Accreditation Program (NELAP), will verify the reliability
and credibility of the analytical results. Additionally, the laboratory reporting limits need to be
lower than the screening levels for each of the analytes analyzed. A copy of the laboratories’
Quality Assurance Manuals (QAM) with the laboratory reporting levels is provided in Appendix
A.
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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 Project Manager will ensure that
training/certification requirements are satisfied for all field personnel prior to their entry to any
project site where investigation 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 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. 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 at UAC R307-801.
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 any field problems and corrective measures taken. Additional field documents will include
sketch maps, field forms, borehole logs, and chain of custody records.
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 a local server hard drive in the Terracon office that
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is backed up automatically on a daily basis to a separate file server hard drive at Terracon’s
corporate office in Olathe, Kansas. In addition, analytical reports and chain-of-custody records
will be maintained indefinitely on the analytical laboratory’s LIMS database, and made available
via the laboratory’s secured online data access system.
Samples will be submitted to the laboratory using standard turnaround times unless alternate
turnaround times are requested on chain of custody records for individual sample sets. It is
anticipated that Chemtech Ford and EMLab (if required) will be used for analyses. If another
laboratory performs analyses, it must meet the following criteria and submit QA/QC
documentation for approval as described above:
n Demonstrated ability to achieve the required detection limits;
n Certified by the State of Utah for the specific analyses;
n 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, chromatograms, and
narrative report of QC results and any corrective actions required; and
n Follows an internal QA/QC Program.
Details of the laboratory QA/QC Programs are presented in Appendix B.
GROUP B MEASUREMENT/DATA ACQUISITION
B1 Sampling Process Design
A SCWP will be developed for each Phase II ESA investigation. Regulatory and historical data
available for the Site, a visual inspection of the property, and any identified issues will be used to
develop the SCWP. The SCWP will be reviewed and approved by the DERR prior to
implementation. The sample results will be used to evaluate whether concentrations of COCs
are above or below Cleanup Levels established in the RAP.
B2 Sampling Methods Requirements
Samples will be collected following applicable Terracon Standard Operating Procedures (SOPs)
included in Appendix B. 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) (U.S. 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 problem and corrective action will
be documented in the field log book.
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B3 Sample Handling, Preservation and Custody Requirements
Samples will be identified, labeled, preserved, and handled following SOP 20, which includes
chain of custody and documentation procedures. An example sample label and chain of custody
form are included as attachments to SOP 20.
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 assessment are summarized in the work plans and are presented here in Table 2. The
primary analytical parameters anticipated for the assessments include, but are not limited to, the
following: volatile organic compounds (VOCs; EPA Method 8260); semi-volatile organic
compounds (SVOCs; EPA Method 8270); metals (EPA Methods 6010//6020/7470/7471);
polychlorinated biphenols (PCBs; EPA Method 8082); Dioxins / Furans (EPA Method 1613), per-
and polyfluoroalkyl substances (PFASEPA Method 537, modified), and 1,4-dioxane (EPA Method
8260 SIM). Soil gas samples, if collected, will be analyzed for VOCs using EPA Method TO-15.
Samples will be placed into the appropriate laboratory-provided container immediately after
collection. The container will remain in the sight of the sampler or will be locked in a secured area
until the samples are transported under chain of custody protocols for delivery to the laboratory.
B4 Analytical Methods Requirements
All 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 QM’s (Appendix B) for analytical SOPs and information regarding
analytical equipment, instrumentation, performance criteria, corrective action procedures and
documentation, sample disposal, and method validation information and procedures for
nonstandard methods. Laboratory turnaround times needed will be specified on chain of custody
records for each sample set.
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:
n Field duplicates
n Field/Equipment blanks (if applicable for individual sites)
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n Trip blanks (if applicable for individual sites)
n Matrix spikes and matrix spike duplicates (MS/MSDs)
n Laboratory method blanks
n Laboratory control samples (LCS)
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 limit (LRL) and the difference between the reported
concentration in the sample and the reported concentration in the duplicate is less than or equal
to the LRL value (for aqueous samples) or less than twice the LRL (for soil/solid samples), the
samples will be considered within control. If the difference is greater than the LRL value, the data
will be flagged and evaluated by the Consultant QA/QC Officer.
The relative percent difference (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 5 times the LRL. The RPD is calculated to evaluate precision using the
following equation.
RPD =௑భି௑మ
ቀ೉భశ೉మ
మ ቁ
ݔ100 Where X1 and X2 are the reported concentrations of the samples
being evaluated.
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 blanks may be collected, as specified in the SCWP.
Acceptance criteria will be analyte concentrations less than the LRLs. If above the LRLs, 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 volatile organic compounds (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
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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 VOC sample shipment where soil and groundwater sample
analyses will include VOCs; and one trip blank will typically be used and analyzed per PFAS
sample shipment.
Matrix Spike (MS) and Matrix Spike Duplicate (MSD) Samples. Samples for MS/MSD
analyses will be selected by the laboratory from the sample set at random and split in the
laboratory. 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 above.
Percent Recovery =௑ೞି௑೔
ௌ஼ ݔ100 Where Xs = concentration measured in spiked sample
Xi = concentration measured prior to spiking, and
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 Chemtech Ford QM (Appendix B). 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. If data fail to meet the
acceptance criteria, the Consultant QA/QC Officer will evaluate the data with the laboratory to
determine 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 of 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.
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.
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Percent Recovery =௑ೞ
ௌ஼ ݔ100 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.
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 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 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. Any identified deficiencies will be documented in the field log
book, along with any corrective actions (e.g., spare parts replacement and instrument re-testing)
and effectiveness of corrective actions.
Each laboratory conducts its own equipment testing, inspections, maintenance, and record
keeping of the laboratory equipment as detailed in the laboratory QMs provided in Appendix B.
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) standards
or equivalent. Calibration deficiencies, if any, will be documented in the field log book along with
their resolution (e.g., spare parts replacement and re-calibration).
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B7.2 Laboratory Instruments
The laboratories QM and SOPs meet all State of Utah, The NELAC Institute, and EPA method
protocols necessary to produce legally and defensible analytical data, as indicated in the Utah
Environmental Laboratory Certification Program (ELCP) document. Certification also applies to
instrument calibration, reference material, standards traceability, data validation, and all 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 is conducted. Records of events and corrective
actions taken by the laboratory to resolve issues and to prevent further occurrences are
maintained.
B8 Inspection/Acceptance Requirements for Supplies and Consumables
Sample containers and other dedicated consumables will meet 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
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 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), bailers, and/or tubing will be used to
collect groundwater samples and will be discarded after use. Prior to use, the materials provided
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.
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
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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 course of 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 log books and forms. Example forms for
typical field data collection are included 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 possible
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 (subject to
daily backup on a separate file server at Terracon’s corporate office in Olathe, KS) and on the
laboratory’s LIMS database system, and can be retrieved via the local server and via the
laboratory’s secured online data access system. Please refer to Appendix B for information
relating to procedures used and individuals responsible for laboratory data processing,
transmittal, storage/archival, and hardware/software configurations.
GROUP C ASSESSMENT/OVERSIGHT
C1 Assessment Activities
Assessment and oversight activities will be conducted by the Consultant QA/QC Officer. There
will be three primary activities conducted by the Consultant QA/QC Officer:
1)Surveillance Level Oversight
The Consultant Project Manager will coordinate the investigation, with independent oversight by
the Consultant QA/QC Officer. Both of these 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. Any deviations from the QAPP will be addressed immediately to
ensure the quality of the data. Surveillance level oversight will be conducted throughout the
duration of field activities.
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2)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.
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3)Data Quality Validation Summary
Within approximately one week of 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 immediately notify the laboratory if any need for
corrective actions is identified. In this case, the laboratory will be required to perform and verify
any 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.
C2 Reports to Management
Data validation summaries will be included as part of the final reports detailing the investigations.
In the event that laboratory corrective actions are required, the Consultant Project Manager will
notify Salt Lake County, and final reports will include copies of both the original and amended
laboratory reports. In the event that field corrective actions are required, the problem and
corrective action will be recorded in the field log book, and will also be documented in the final
report. Copies of the final reports detailing the investigations will be sent to all 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 ensures that the results conform to the users’ needs.
D2 Validation and Verification Methods
All 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 QM (Section 5.4) in Appendix B.
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
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laboratory as a Level III data package which will include the final analytical report with qualifiers
where necessary; chain of custody records; and results for method blanks, MS/MSD analyses
with control limits; LCS summary with control limits; reporting limits listed on all reports; surrogate
recoveries for GC and GC/MS analyses; initial and continuing calibration information; and
instrument blank performance.
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.
Any 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.
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 including 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
U.S. Environmental Protection Agency.Guidance for Preparing Standard Operating Procedures
(SOPs) (QA/G-6). EPA/600/B-07/001, April, 2007.
U.S. Environmental Protection Agency.Data Quality Assessment: A Reviewer’s Guide (QA/G-
9R). EPA/240/B-06/003, February, 2006.
U.S. Environmental Protection Agency.Data Quality Assessment: Statistical Tools for
Practitioners (QA/G-9S). EPA/240/B-06/002, February, 2006.
U.S. Environmental Protection Agency.Guidance for Quality Assurance Project Plans (QA/G-5).
EPA/240/R-02/009, December, 2002.
U.S. Environmental Protection Agency.Guidance on Systematic Planning Using the Data
Quality Objectives Process (QA/G-4). EPA/240/B-06/001, February, 2006.
U.S. Environmental Protection Agency.Data Quality Objectives Process for Superfund –
Interim Final Guidance. Pub. No. 9355-9-01, September, 1993.
U.S. Environmental Protection Agency.Regional Screening Levels (RSLs).
www.epa.gov/risk/regional-screening-levels-rsls
U.S. Environmental Protection Agency. National Primary Drinking Water Regulations.
www.epa.gov/ground-water-and-drinking-water/national-primary-drinking-water-regulations
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Table 1
Data Quality Indicators (DQIs)
Parameter QC Program Evaluation Criteria Summary of QA/QC Goals
Precision Field Duplicate Pairs RPDa
RPDs will be less than ± 25% (aqueous samples) and ± 50% (solid
samples) when detected concentrations are ≥ 5x the LRL. When
detected concentrations are <5x the LRL and the difference between
the reported concentrations is less than or equal to the LRL value
(for aqueous samples) or less than twice the LRL (for soil/solid
samples), the samples will be considered within control.
Bias
Laboratory Control Sample Percent Recoveryb
LCS percent recoveries will vary by sample medium, analyte,
and method, and may be either method defaults or laboratory-
derived.
Matrix Spike/Matrix Spike
Duplicate (MS/MSD)
Percent Recoveryb
RPDa
MS/MSD percent recoveries and RPDs will vary by sample
medium, analyte, and method, and may be either method
defaults or laboratory-derived.
Accuracyc Method Blanks LRL Less than LRL
Equipment Blanks LRL Less than LRL
Representativeness
Standard Operating Procedures
(SOPs)
Qualitative determination of SOP
adherence All samples collected following SOPs
Holding Times Holding Times All samples analyzed within holding times
Field/Equipment Blanks LRL Less than LRL
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 SOP
adherence All samples collected following SOPs
QC Samples
10% Field Duplicates
10% Field Blanks
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 LRL 100% of LRLs are less than Performance Standards
a: RPD =௑భି௑మ
ቀ೉భశ೉మ
మ ቁ
ݔ100; where X1 and X2 are the reported concentrations of the samples being evaluated.
b: Percent Recovery =௑ೞି௑೔
ௌ஼ ݔ100; 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 ESC’s Standard Operating Procedures.
LRL - Laboratory Reporting Limit
RPD - Relative Percent Difference
SOP - Standard Operating Procedure
Quality Assurance Project Plan
Redwood Road Dump Pilot Phase VCP ■ Salt Lake City, Utah
Asbestos Building Material
EPA Methods:
600/M4-82-020 and
600/R-93/116
<1%NA NA NA NA NA
VOCs Soil SW-846 8260 0.002 - 0.12 mg/kg 4 oz glass 1 NA 4 deg C*14
VOCs (including 1,4-
dioxane)Groundwater SW-846 8260 0.2 - 40 ug/L 40 ml liter 3 HCL 4 deg C*14
SVOCs Soil SW-846 8270 0.01 - 0.1 mg/kg 4 oz glass1 1 NA 4 deg C*14
SVOCs Groundwater SW-846 8270 0.5 - 4 ug/L 60 ml amber glass 4 NA 4 deg C*7
Barium, Cadmium,
Chromium, Silver Soil SW-846 6010 0.271 mg/kg 4 oz glass1 1 NA NA 180
Arsenic, Lead,
Selenium Soil SW-846 6010 2.71 mg/kg 4 oz glass1 1 NA NA 180
Mercury Soil SW-846 7471 0.03 mg/kg 4 oz glass1 1 NA NA 28
Dissolved Metals Groundwater SW-846 6020 0.0005 mg/L 250 ml plastic2 1 HNO3 NA 180
Dissolved Metals -
Mercury Groundwater SW-846 7470 0.0002 mg/L 250 ml plastic2 1 HNO3 NA 28
PFAS Groundwater 537 Mod 20 ng/L 1 L amber glass 1 NA 4 deg C*28
TDS Groundwater SM 2540 C 20 mg/L 1 L plastic 1 NA 4 deg C*7
PCBs Soil 8082 2 ug/L 4 oz glass1 1 NA 4 deg C*7
Dioxins/furans Soil 8290 0.196 - 4.14 ng/kg 4 oz glass 1 NA 4 deg C*365
1glass - may be combined with other analyses
2combined with other dissolved metals analyses and filtered in the field
L = liter; mg = milligrams; ug = micrograms; ng = nanograms; oz - ounce
HCL = hydrochloric acid; HNO3 - nitric acid
NA - Not Applicable / Not Required
*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 2
Maximum
Holding Time
(days)
Temp
Method Summary
PreservativeParameterMatrixAnalytical Method
Laboratory Method
Detection Limit
(MDL)
Container Volume
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Table 3
Data Validation and Verification Methods
Data Validation and Verification Requirements Data Validation and Verification Methods
n Samples were collected as per scheduled
locations and frequency.
n Comparison with Site Characterization Work
Plan.
n Sample collection and handling followed
specific procedures (i.e., relevant SOPs and
chain of custody procedures).
n Review of field notes, sampling logs and
COCs.
n Surveillance-level oversight of field
procedures to maximize consistency in field.
n Appropriate analytical methods were used,
and internal laboratory calibration checks
were performed according to the method-
specified protocol.
n Review of analytical methods and case
narratives provided with laboratory reports.
n Maintain documentation of communications
with laboratory regarding problems or
corrective actions.
n Required holding times and laboratory
reporting limits were met.
n Comparison with specified holding times and
LRLs.
n Recovery acceptance limits for field and
laboratory QC samples (MS/MSD, LCS, and
method blanks) were met.
n Comparison with specified acceptance limits.
n Comparison with Data Quality Indicators.
n 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.
n Maintaining a permanent file of hard copies of
laboratory analytical reports.
n Minimizing retyping of data.
n Double-checking values entered into
database, tables, and maps against
laboratory reports.
APPENDIX A
Relevant Standard Operating Procedures (SOPs) and Field Forms
SOP 1-1
SOP 1
Soil Sampling and Logging
Introduction
This SOP describes the procedures for properly collecting, handling, and logging soil samples
(when required). Method-specific sampling techniques are presented in the following SOPs:
SOP 2 Surface Soil Sampling
SOP 4 Test Pit and Excavation Soil Sampling
SOP 5 Direct-push Drilling Sampling
SOP 13 Field Instrument Calibration
SOP 17 Equipment Decontamination
SOP 20 Sample Handling and Documentation
Equipment
Equipment needs will vary, depending on the sample collection or drilling method. Refer to
the appropriate SOP listed above for method-specific equipment needs.
Procedures
Non-Sleeved Grab Samples
Immediately upon receiving the sample, either from the split spoon or backhoe bucket, the
material will be screened with the appropriate direct reading instrument, such as a PID or
XRF, and the reading will be recorded on the log form or in the field notebook. The portion of
the sample collected for chemical analysis will be transferred immediately into the appropriate
sample container using decontaminated equipment, new wooden tongue depressors, or by
hand wearing new disposable chemical-resistant gloves. Avoid gravels and rock fragments
when filling soil sample containers. If the sample is to be analyzed for volatile organics, the
container will be completely filled with soil to minimize headspace. The container will be
labeled appropriately following SOP 20 and immediately stored in an iced cooler to maintain
a temperature of 4° Celsius.
Grab Samples Using Sleeves (auger drilling methodology)
When sampling for volatile compounds, the sample will be kept in the brass or plastic sleeves,
and the sleeves will be handled with chemical-resistant gloves. The sample will be screened
with the direct reading instrument by exposing the end of one sample tube to the instrument
probe. The sample sleeve selected for chemical analysis will be packaged immediately by
covering each end of the sleeve with Teflon™ tape and sealed with plastic caps. The sample
sleeve will be labeled as described above and immediately stored in an iced cooler to maintain
a temperature of 4° Celsius.
Grab Samples Using Sleeves (Direct-push drilling methodology)
The sample sleeve will be cut and the sleeves will be handled with chemical-resistant gloves.
The sample will be screened with the direct reading instrument by removing a portion of the
sleeve, exposing the soil to the instrument probe. The soil sample selected for chemical
analysis will be packaged immediately into laboratory-supplied soil jars, labeled as described
above, and immediately stored in an iced cooler to maintain a temperature of 4° Celsius.
SOP 1-2
Composite Soil Samples
Composite samples will be prepared by placing equal amounts of soil in a stainless steel bowl
or a clean plastic bag using a stainless steel spoon or by hand wearing new chemical-resistant
gloves. The sample will be homogenized with a stainless steel spoon or gloved hand. The
homogenized soil will be packaged in a laboratory-supplied sample container, labeled
appropriately, and placed in an iced cooler to maintain a temperature of 4° Celsius. Note that
samples for VOC analysis will not be composited.
Soil Logging
When a detailed log of soils is required by the Sampling and Analysis Plan, soil will be logged
following the procedures outlined below. The level of detail for soil logging will depend on the
Data Quality Objectives and intended use of the log information. A description of visual soil
characteristics will be recorded for all soil samples. The soil description may include the
following information (in the order listed below):
n Soil type according to unified soil classification system
n Color according to the Munsell color chart
n Grain size and roundness
n Percentage fines, sands, and gravels
n Presence of interbedding, and number and thickness of layers
n Description of odors, staining, or sheen
n Density or stiffness
n Relative moisture content
A description of soil types and various field tests for soil classification is given at the end of
this SOP.
The following information will be recorded in the appropriate spaces provided on the sample
log form:
n Depth of all drive samples;
n Sample interval submitted for laboratory analysis;
n Meter reading from direct-reading instrument (if applicable);
n Contacts between soil types.
In addition to logging soils, the geologist will record the occurrence of first water and the
approximate static water level within each borehole. The reference point for all subsurface
measurements will be included on all boring logs (i.e., feet below ground surface).
Decontamination
Strict decontamination procedures, as outlined in SOP 17, will be used to prevent cross-
contamination of samples. Decontamination will be performed on non-disposable sampling
equipment, including drilling equipment (e.g., auger barrel, split spoon) and hand tools (e.g.,
shovels, hand augers, etc.
When possible, samples will be collected using disposable equipment to avoid the need for
decontamination.
Unified Soil Classification System (when required)
SOP 1-3
The following is an overview of classifying soil according to the USC system. The distinction
between soil types is based on the percentage of fine vs. coarse material in a sample. This
is easily done in a laboratory but involves a lot of guesswork in the field. The key is to be
consistent. If you are fortunate enough to have samples submitted to a geotechnical lab for
sieve analysis, check your field classifications against the laboratory results. This will help
you estimate percentages in the field.
1) Distinguishing Coarse-grained from Fine-grained Soils:
A) Determine if material is predominantly coarse grained (sand or gravel) or fine grained
(silt or clay). Coarse-grained materials are those with more than 50% retained on a
No. 200 sieve (very fine-grained sand or larger).
B) If coarse-grained, determine if it is predominantly sand or gravel. Be aware that in the
USCS system, pea gravel-size particles are considered “very coarse grained sand.”
C) Further classify material based on the amount of fines present. Roughly, no or very
little fines is a SP or GP classification; slight amount of fines is a GP-GM or a SP-SM
classification; much fines is a GM or SM classification. The following chart shows the
breakdown for these classifications.
Classification of Coarse-grained Sands
>50% larger than No. 200 sieve
Percentage Fines Soil Name USC Designation
<5% Fines Gravel GP or GW1
Sand SP or SW1
5-12% Fines Gravel with Silt or Clay GP-GM or GP-GC
Sand with Silt or Clay SP-SM or SP-SC
>12%Silty or Clayey Gravel GM or GC
Silty or Clayey Sand SM or SC
1 - The designation SW or GW means well sorted -not well graded (confusing for
geologists). This is a condition not normally found in natural depositional
environments and usually indicates engineered fill. Do not use this classification
unless you think the material is specifically graded-engineered fill.
D) If material is fine grained, determine if any coarse-grained materials are present. Note
that all fine-grained materials have the same USC designation. Therefore, you must
use both the name and the designation to adequately describe the soil. Use the
following chart to classify fine-grained materials.
SOP 1-4
Classification of Fine-grained Soils
>50% passing No. 200 sieve
Percentage Coarse Soil Name USC Designation
<15% Coarse Silt ML, MH
Clay CL, CH
15-29% Coarse Silt w/Coarse ML, MH
Clay w/Coarse CL, CH
>29% Coarse Sandy Silt ML, MH
Gravelly Silt ML, MH
Sandy Clay CL, CH
Gravelly Clay CL, CH
2) Classification of Fine-grained Soils
A) Distinguish clay from silt. The following are field tests for determining if a material is
clay or silt.
1) Dilatency (reaction to shaking)
Remove course-grained materials. Prepare a pat of moist soil with a volume of
about 1/2 cubic inch. Add enough water if necessary to make the soil soft but not
sticky. Place the pat in the open palm of one hand and shake horizontally, striking
vigorously against the other hand several times. A clean fine-grained sand will
rapidly show water on the surface and become glossy. When squeezed between
fingers, the gloss disappears from the surface, the pat stiffens and finally cracks or
crumbles. A very plastic clay will show little reaction to shaking and squeezing; an
inorganic silt will react somewhere in between.
2) Dry strength (crushing characteristics)
After removing coarse-grained particles, mold a pat of soil to a 1/2-inch cube,
adding water, if necessary. Allow to dry completely. Test the strength of the dry
cube by crushing between fingers. The dry strength increases with increasing
plasticity, with a plastic clay having high dry strength. An inorganic silt and silty
fine-grained sands are similar. Fine sand feels gritty where silt has a smooth, flour-
like feel.
3) Toughness (consistency near plastic limit)
The worm test: roll soil into a rope (or worm). A clay can usually be rolled to 1/8-
inch diameter before it breaks.
B) CH vs. CL and MH vs. ML
SOP 1-5
C) Additional Characteristics
1) Relative Density (coarse-grained material)
Blows per foot Relative Density
<4 very loose
4 - 10 loose
10 - 30 medium dense
30 - 50 dense
> 50 very dense
2) Consistency (fine-grained material)
Blows per foot Consistency Field Test
0 - 2 very soft easily penetrated several inches with fist
2 - 4 soft easily penetrated several inches with thumb
4 - 8 medium stiff penetrated several inches by thumb with
moderate effort
8 - 15 stiff readily indented by thumb but penetrated only
with great effort
15 - 30 very stiff readily indented by thumbnail
> 30 hard indented with difficulty by thumb nail
3) Relative Moisture
Moisture is measured relative to its optimum water content for compaction. Use
the following descriptions:
Relative Moisture Field Test
Dry does not contain water.
Slightly Moist damp, will not hold together.
Moist soil will reach its maximum compaction under
pressure.
Wet contains excess moisture for compaction.
Saturated below the water table.
SOP 2-1
SOP 2
Surface Soil Sampling
Introduction
This SOP describes the procedures for sampling surface soils from ground surface to 12
inches below ground surface. Samples may be collected with decontaminated hand tools.
Equipment
n Hand tools (e.g., shovels, spoons, etc.)
n Sample driver apparatus
o Drive barrel
o Brass sleeves
o Rod and slide hammer
n Teflon™ tape and end caps to seal brass sleeves
n Laboratory-supplied sample containers if not using brass sleeves
n Decontamination Supplies
o Buckets
o Alconox Detergent
o Distilled water
o Scrub brush
n Direct Reading Instrument (PID and/or XRF)
n Tape Measure
n Log Forms/Field Notebook
Preliminaries
Soil sample locations will be determined from the project-specific work plan. If necessary,
concrete coring will be arranged before mobilizing to the field.
Procedures
Soil will be collected and placed into laboratory-supplied sample containers with
decontaminated hand tools or with a gloved hand. Coarse-grained soils, such as gravel and
rock fragments, will be avoided whenever possible. To prevent loss of volatiles, soil will be
packed tightly inside the sample container to minimize headspace.
If soil samples are being collected with a sample driver, brass sleeves will be placed inside
the sample barrel and the sampler will be driven to the desired depth with the slide hammer.
After the sample barrel is retrieved, the brass sleeves will be removed and the ends of each
sleeve will be covered with Teflon™ tape and sealed with plastic caps.
Samples will be labeled appropriately and immediately stored in an iced cooler to maintain a
temperature of 4° Celsius. The sample depths and locations will be measured and
documented in the field notebook with the soil description.
SOP 4-1
SOP 4
Test Pit/Excavation Soil Sampling
Introduction
This SOP describes the equipment and procedures for collecting soil samples from test pits
and excavations. Samples may be collected from the backhoe bucket or from the excavation
wall, provided the excavation meets safe entry requirements.
Equipment
n Hand tools (e.g., shovels, spoons, etc.)
n Sample containers
n Decontamination supplies
o Buckets
o Alconox detergent
o Distilled water
o Scrub brush
n Direct reading instrument
n Tape measure
n Log forms/field notebook
n Laboratory-supplied sample containers
Preliminaries
Sample locations will be determined using the project-specific work plan. Arrangements will
be made for the location of underground utilities using Blue Stakes. When necessary, a
private locating service will be used for utilities that are not covered by Blue Stakes.
Procedures for Sampling from Backhoe Bucket
Soil within the backhoe bucket will be screened with the appropriate direct reading instrument
and readings will be recorded in the field notebook. Soil samples selected for laboratory
analysis will be collected from the backhoe bucket, taking care to avoid sloughed material and
avoiding material that has been in direct contact with the backhoe bucket. Samples will be
packed in laboratory-supplied containers to minimize headspace. Each sample will be labeled
following SOP 20.
Procedures for Sampling Directly from Pit Wall (less than 5 feet deep)
A fresh surface will be scraped from the pit wall using decontaminated hand tools. The soil
on the pit wall will be screened with a direct reading instrument and the reading will be
recorded in the field notebook. A soil sample will be collected by either pushing a brass sleeve
into the wall of the excavation, or by removing material with decontaminated hand tools or
gloved hand and packing it into the sample container. To prevent loss of volatiles, the brass
sleeve or sample jar should be packed full so that no headspace is present. Each sample will
be labeled following SOP 20.
SOP 4-2
Decontamination
Strict decontamination procedures, as outlined in SOP 17, will be used to prevent cross-
contamination of samples. Decontamination will be performed on non-disposable sampling
equipment, including drilling equipment (e.g., auger barrel, split spoon) and hand tools (e.g.,
shovels, hand augers, etc.
SOP 5-1
SOP 5
Direct-push Drilling Sampling
Introduction
Direct-push drilling equipment will be used to advance shallow soil borings (generally 30 feet
or less) to collect soil and groundwater samples and for sites where access restrictions
prevent mobilization of a larger drill rig. Standard operating procedures for direct-push soil
and groundwater sampling are described below.
Preliminaries
Direct-push drilling sample locations will be marked or staked in the field and coordinated with
the Terracon project manager and, if necessary, the client's project manager. Blue Stakes
utility clearance will be requested for each boring location prior to direct-push sampling.
Borings will be located at least two feet from marked underground utilities.
All sampling equipment will be decontaminated according to SOP 17 prior to initiating drilling
activities. This equipment includes all direct-push drill rods, samplers, and hand tools.
Direct-push Drilling Equipment and Procedures
Soil borings will be advanced and sampled using a hydraulic hammer mounted to a truck, van,
three-wheeler, or small tractor. Each borehole will be started by hydraulically hammering steel
drill rod with a disposable pointed steel end point into the ground. The borehole will be
advanced in regular increments, available in varying lengths from 2 to 5-feet, by adding
sections of flush-threaded drill rod to the drill stem already in the ground. No lubricants or
additives will be used while advancing direct-push borings.
Soil Sampling Equipment
The following equipment will used to conduct soil sampling:
n Direct-push core samplers (supplied by the drilling contractor)
n New polybuterate sample liners (supplied by the drilling contractor)
n New sample liner end caps (supplied by the drilling contractor)
n Chemical-resistant gloves
n Appropriate personal protection equipment according to the HASP
n Sealable plastic bags
n Sample labels
n Laboratory-supplied glass soil sample jars and labels (optional)
n Stainless steel putty knife
n Stainless steel bowl and spoon
n Photoionization detector (PID)
n Cooler and ice
n Munsell color chart, if required
n Unified Soil Classification System (USCS) chart, if required
SOP 5-2
Soil Sampling
Samples will be collected as specified in the site-specific sampling plan. At a minimum, soil
samples will be collected at regular intervals if lithologic information is needed. Each soil
sample will be collected in a drill rod sampler lined with a clear polybuterate sample sleeve.
The sampler will be attached to the drill rod, lowered to the sample interval, opened, and then
hydraulically hammered into the subsurface.
Soil samples for laboratory analyses can be collected directly in the samples’ sleeves or may
be transferred from the sleeves to laboratory-supplied sample containers using
decontaminated hand tools or by hand wearing new chemical-resistant gloves.
Soil Sampling Using the Driller’s Sample Sleeves
The polybuterate sleeves may be used as sample containers, using the following procedure.
After the sampler has been retrieved from the borehole, the sample shoe will be removed from
the sampler and the soil contents will be sealed in a plastic bag for headspace analysis. If the
sample shoe is empty, a small amount of soil will be removed from the portion of the liner
immediately above the sample shoe. The soil will be allowed to equilibrate in the plastic bag
for approximately 15 minutes. The headspace vapors inside the bag will be measured by
pushing the PID tip through one side of the plastic bag into the headspace of the bag. The
maximum PID reading over a 30-second interval will be recorded at the corresponding depth
on the soil-boring log. Following headspace sample collection, soil will be removed from each
end of the polybuterate liner for soil classification. If recovery is poor, the headspace sample
will be used for soil classification after the headspace reading has been measured and
recorded on the boring log. The polybuterate liner will be trimmed flush on each side to
minimize headspace, and each end will be covered with Teflon tape. Each end of the liner
will then be sealed tightly with polybuterate end caps. The sample will be labeled and
immediately placed in an iced cooler to maintain a temperature of 4°C.
In general, the sample liner associated with the highest headspace reading will be submitted
for VOC and semi-VOC analysis. If headspace readings are zero for all samples, odors, soil
staining, and clay-rich (high sorption) lithology will be used as selection criteria.
Soil Sampling Using Laboratory-Supplied Soil Jars
The sample sleeve will be cut and the sleeves will be handled with chemical-resistant gloves.
The sample will be screened with the direct reading instrument by removing a portion of the
sleeve, exposing the soil to the instrument probe. The soil sample selected for chemical
analysis will be packaged immediately into laboratory-supplied soil jars, labeled as described
above, and immediately stored in an iced cooler to maintain a temperature of 4° Celsius.
Sample Selection Criteria for Laboratory Analysis
In general, the sample liner associated with the highest headspace reading will be submitted
for VOC and semi-VOC analysis. If headspace readings are zero for all samples, odors, soil
staining, and clay-rich (high sorption) lithology will be used as selection criteria.
SOP 5-3
Groundwater Sampling
To facilitate the collection of groundwater samples at sites where the water table is penetrated,
a temporary well point will be installed in the direct-push borehole. After the water table has
been encountered, the borehole will be advanced at least three more feet to ensure adequate
sample volume. The well point may consist of either a three-foot long stainless steel screen
drill rod attachment or slotted PVC screened in a similar interval. New tubing and well screens
will be used for each well point. A peristaltic pump will be attached to the tubing to obtain
groundwater samples by the following analyte order in the appropriate laboratory-supplied
pre-preserved sample containers:
1) VOCs and BTEXN
2) Semi-VOCs
3) Total Petroleum Hydrocarbons
4) Oil and Grease
5) Filtered metals
Groundwater samples collected for dissolved metals analysis may be field filtered using in-
line filters attached to the outlet tubing of the peristaltic pump or with NalgeneTM hand-pump
filters.
The sample will be labeled and immediately placed in an iced cooler to maintain a temperature
of 4°C.
Boring Abandonment
After all soil and groundwater samples have been collected, each soil boring will be backfilled
with granular bentonite. Borings that were drilled through asphalt or concrete will be backfilled
with granular bentonite to within six inches of the ground surface and the asphalt and concrete
cores will be restored.
Demobilization
After the equipment has been rigged down and loaded, the site will be cleaned and restored
as close to its original condition as possible. All sampling equipment will be decontaminated
prior to mobilizing to the next direct-push drilling sample location.
SOP 9A-1
SOP 9A–SOIL GAS SAMPLING
Introduction
This SOP describes the equipment, criteria, and procedures that will be used to collect samples
from soil gas probes. Some deviations from this SOP may be necessary because of site-specific
conditions. This SOP applies to soil gas probes installed up to 5 feet below the ground surface
(bgs).
Equipment
Below is a checklist of equipment for conducting soil gas probe sampling:
n Direct Reading Instrument (e.g., MGD-2002 gas meter for helium))
n Necessary fittings to complete the sample train;
n Log Forms
n Batch-certified clean Summa® canisters, using new Teflon® tubing and flow
regulator to be supplied by the laboratory;
n Peristaltic pump for evacuating the tubing and filling Tedlar bags with helium for
leak detection testing.
Procedures
Summa Canister Sampling
Soil vapor samples will be collected in laboratory-supplied, batch-certified clean Summa®
canisters, using new Teflon® tubing and a flow regulator that will restrict flow to no more than 200
mL per minute.
In order to ensure the soil vapors collected are representative of subsurface pore spaces, the soil
probe and attached tubing will be evacuated of three volumes of the vapor point annulus and
attached Teflon®-lined or Tygon® tubing prior to sampling. The sample train will be constructed
in a manner that allows for annulus purging and sample collection without disconnecting the
sample train. The canister will be connected to the sampling port using dedicated Teflon®-lined
or Tygon® sample tubing connected to a sample train.
Leak detection will be conducted using two separate methods. First, a shut-in test will be
conducted on the sample train after it is fully assembled. Shut-in tests involve pulling a vacuum
on the sample train and monitoring the vacuum on an inline vacuum gauge. If the sample train
holds vacuum, the sample train will be deemed to be airtight. The second test measures the
integrity of the sample train by introducing helium gas in the vicinity of the sample train while a
vacuum is being applied. Air from the vapor point and tubing will be purged and collected in a
new Tedlar bag. While the purging occurs, the sample point and sample train are placed under
a shroud that is filled with 15-20% helium by volume. The helium percentage in the shroud is
monitored with a MGD-2002 gas meter. The purged air collected in the Tedlar bag is then tested
with the gas meter. If the purged air contains less than 5% of the shroud’s helium content, the
sample train will be deemed to be airtight. This process is repeated three times to ensure the
sample train’s integrity and to purge the appropriate three volumes of air from the vapor point
annulus through the entire sample train.
SOP 9A-2
Once purging has been completed, open the Summa canister valve. The flow rate for the Summa
canister will vary, depending upon desired results (e.g., for comparison to PELs or TLVs). Once
sampling is complete, close the valve of the canister and disconnect the tubing. Document the
flow rate, the time the canister’s regulator was opened, and the time the canister’s regulator was
closed. The Summa canister should not be completely filled (i.e. the valve should be shut when
the vacuum gauge reads between 2 to 4 inches of Hg). Document the vacuum gauge reading.
Mark the sample canister with the sample identification, date and time of collection, and the
sampler’s initials. Document all of the sampling methodologies used in the project field log form.
SOP 10B-1
SOP 10B
Monitoring Well Design and Installation (using direct-push drilling)
Introduction
This SOP describes procedures for the drilling and installation of shallow monitoring wells
within the unconfined water table aquifer using direct-push drilling equipment. Site-specific
conditions may warrant deviating from these standard designs. Field personnel should
consult with the project manager and the work plan before deviating from the basic design.
Well Design
The typical well design to be used is intended to provide water samples of the upper 5-10 feet
of the water-bearing zone. The well screens will be 10-feet long and will be set so that the
top of the screen is at least two feet above the highest-observed water level.
Casing and Screen Materials
In general, well materials will be 1-inch to 2-inch-diameter, schedule 40, flush-threaded, PVC.
All joints will be flush-threaded. The perforated zone will be constructed from machine slotted
0.010-inch or 0.020-inch slot screen. A six-inch long sump (silt trap) will be placed at the
bottom of the screen. Depending on site conditions, well materials can vary, including different
diameter casings, different schedule ratings for the PVC, etc.
Sand Pack
The sand pack material will be a commercially packaged, inert, non-carbonate, well rounded,
sieved, product of clean, silica sand. In general, a sand of 16-40 to 10-20 mesh should be
used with 0.020-inch slot well screen. The sand pack will be placed from the bottom of the
boring up to 1 foot above the top of the screened section.
Bentonite Seal
A bentonite seal will be installed in the annulus above the sand pack to prevent grout from
infiltrating into the screen and sand pack zone. Bentonite chips may be used for the seal if it
is placed above the water table. Pellets should be used below the water table, as they have
a higher density than the chips and will settle through the water better.
Annular Seal
Shallow wells (less than 20 feet of annulus above the bentonite seal) can be sealed with
bentonite chips, which are hydrated in place with potable water. Wells that have a longer
annular space should be sealed with a cement grout mix.
Drilling and Installation Methods
Drilling Equipment
Boreholes for monitoring wells will be installed using direct-push drilling equipment unless
field conditions dictate otherwise. The inside diameter of the rods should be at least 1 inch
larger than the outside diameter of the well casing to allow room for a filter pack and grout
seal to be installed through the rods.
SOP 10B-2
Borehole Drilling
The borehole for the well casing will be drilled using direct-push rods. No lubricants,
circulating fluid, drilling muds, or other additives will be used during drilling.
During drilling, native soil samples will be retrieved in clear polybuterate sleeves within the
direct-push rods. The collected samples will be logged per the sampling work plan
requirements, which may include soil type (Unified Soil Classification), moisture, and color.
Selected samples may be submitted for chemical and physical analysis if called for in the work
plan.
Once the borehole has been drilled to the desired depth, the subcontractor will prepare to
install the well. The drill rods will remain in the ground to ensure stability of the borehole
during well construction.
Well Casing Installation
Clean chemical-resistant gloves will be worn by drilling personnel while handling the well
screen and casing. All lengths of well casing and screen will be measured and recorded in
the field log book prior to well installation.
Filter Pack Installation
The filter sand pack will be installed by slowly pouring silica sand through the direct-push rods
as they are slowly removed from the borehole. By this procedure, the rods act as a tremie
pipe and will prevent sand from bridging inside the rods. The level of sand pack inside the
annular space will be continuously monitored. As the rods are pulled upward, the sand settles
out through the bottom and additional sand pack will be added at the surface. By adding sand
pack this way, the borehole will remain open and free from cave-ins, and the well casing will
remain centered within the sand pack and the borehole.
Bentonite Seal Installation
After the appropriate amount of sand pack has been added and its depth verified, the
remaining annulus will be sealed with bentonite. Once the desired thickness of bentonite is
in place, the bentonite will be allowed to settle for approximately 30 minutes. The thickness
of the bentonite seal will be verified and subsequently hydrated using potable water.
Flush-Mount Completion
After the grout has cured, the PVC well casing will be cut so that it is approximately three
inches below the ground surface. The top of the PVC well casing will be sealed with a locking
expandable well cap, or PVC cap, and an 8-inch flush-mount well vault will be installed at the
surface with cement. The cement surface surrounding the vault cover will be slightly mounded
to cause surface water to drain away from the well so that the well vault will not fill with water.
SOP 12-1
SOP 12
Groundwater Monitoring Well Sampling
Introduction
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.
Equipment
Below is a checklist of equipment for conducting groundwater sampling:
n Tools for opening well covers
n Keys to wells
n Water-level indicators
o Dual-phase (if free product is suspected)
o Single phase
n Positive displacement pump
n pH, conductivity, and temperature meters
n Standards for pH calibration
n In-line filters for metals samples
n Chemical resistant gloves
n Laboratory-supplied sample containers
n Iced cooler
n Field Notebook
n Chain of custody form
n Appropriate personal protection equipment according to HASP
n Photoionization detector (optional)
n Drum(s) for purge water containment
n Drum labels
n Permanent marker
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.
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 field logbook.
The lock and well cap will then be removed from the well casing and depth to water and total
depth will be measured.
SOP 12-2
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,
disposable bailer, peristaltic pump with new 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.
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)(1)
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:Casing Volume = (TD-DTW feet) (0.16 gallons/foot)
Total Purge Volume = Casing Volume x 3
For a 4-inch diameter well casing:Casing Volume = (TD-DTW feet) (0.65 gallons/foot)
Total Purge Volume = Casing Volume x 3
Stabilization Parameters
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:
n pH readings are consistently within 0.2 pH units;
n temperature is within 0.5˚C of the last reading;
n conductivity is within 10 percent of the last reading.
SOP 12-3
Groundwater Sample Collection
A complete set of laboratory-supplied sample containers will be prepared and labeled prior to
collecting groundwater samples. A disposable bailer or low-flow peristaltic pump will be used
to obtain groundwater samples by the following analyte order in the appropriate pre-preserved
sample containers:
1)PFAS
2)VOCs;
3)Semi-VOCs;
4)Filtered metals
All 40-milliliter containers will be filled so that no headspace is present in the container after
the lid has been fastened. Groundwater samples collected for dissolved metals analysis may
be field filtered using inline filters attached to the outlet tubing of a peristaltic pump or with a
Nalgene™ hand-pump filter press. The labels for each groundwater sample will be double-
checked and immediately placed in an iced cooler to maintain a temperature of 4˚C.
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:
n Site Identification
n Monitoring Well Identification
n Volume (Gallons) of Purge Water
n Terracon
n Terracon Project Manager (Name)
6949 South High Tech Drive
Midvale, UT 84047
801-545-8500
The final disposition of the purge water will depend on groundwater analytical results and
contract specifications.
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.
Demobilization
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.
SOP 12A-1
SOP 12A Monitoring Well Sampling Using Low-flow Methods
Introduction
This SOP describes the equipment, criteria, and procedures that will be used to sample
groundwater monitoring wells using low-flow (micropurging) methods. Some deviations from this
SOP may be necessary because of site-specific conditions. Well sampling should be completed at
least 24 hours after the wells have been developed.
Equipment
Below is a checklist of equipment for conducting groundwater sampling:
·Tools for opening well covers
·Keys to wells
·Water-level indicators
- Dual-phase (if free product is suspected)
- Single phase
·Low-flow micropurge pump
·Hydrolab with flow-through cell
·Standards for Hydrolab calibration
·In-line filters for metals samples
·Chemical-resistant gloves
·Laboratory-supplied sample containers
·Iced cooler
·Field notebook
·Chain-of-custody form
·Appropriate personal protection equipment according to HASP
·Photoionization detector (optional)
·Drum(s) and label(s) for purge water containment (if specified in Work Plan)
·Permanent marker
Preliminaries
All equipment will be decontaminated as described in SOP 17 prior to mobilizing to the site. All
equipment requiring calibration will be calibrated at the equipment warehouse prior to mobilizing
to the field. The operating condition of pump will be checked prior to field mobilization.
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 field log book. The lock
and well cap will then be removed from the well casing and depth to water and total depth will be
measured.
Equipment
The wells will be evacuated with a low-flow micropurge pump. New tubing will be used for each
well. Stabilization parameters will be measured in line with a Hydrolab flow-through cell (or
SOP 12A-2
equivalent instrumentation). The meter will be calibrated according to manufacturer's
specifications.
Purging Procedures
·Measure depth to water and total depth of each well
·Calculate one volume of the screened or open interval as performed in the following
example:
10 foot screen, 2-inch well diameter = 10 feet x 0.1632 gal/foot = 1.632 gal
1.63 gal x 3.785 liters/gal = 6.17 liters or 6.17 liters x 1,000 mL/liter = 6171 mL
·Calculate the time required to purge one well volume, assuming a purge rate of 200
mL/min:
6171 mL ÷ 200 mL/min = 30.85 minutes to purge one volume
Calculating the purge volume will be helpful in determining when stability of the water-borne
constituents can be expected.
·Lower pump to the mid-point of the screened interval.
·Inflate packer (if used) just above top of screen to isolate the screened interval.
·Begin to purge well. USEPA recommends a purge rate of 200 to 300 mL/min. Actual
purge rates will be site-specific. If the packer is not used, the purge rate should not
exceed the recharge rate (i.e., no drawdown in static water level).
·Measure water quality parameters specified in the Work Plan (pH, temperature,
turbidity, conductivity, , and dissolved oxygen) with a flow-through cell at 3 to 5
minute intervals. These parameters should begin to stabilize at one-half the screened
area volume.
·Once the above-mentioned parameters have stabilized within 10% over three
readings, sampling can begin.
Sampling Procedures
Using the well purging pump already in place, the sample will be collected out of the pump
discharge line. The sampling rate can be maintained at 200 mL/min for collecting samples for
metals analysis. The flow-through cell will be disconnected or bypassed during sample collection.
If analyzing for dissolved metals, the samples will be collected through an in-line, disposable,
0.45-micron pore filter.
Purge Water Disposal
Purge water will be thin-spread on the ground, either in the area around the well or on asphalt or
concrete. .
Decontamination
SOP 12A-3
All sampling equipment will be decontaminated according to SOP 17 before mobilizing to the site.
If more than one well will be sampled, sampling equipment must be decontaminated between
wells.
Demobilization
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.
SOP 13-1
SOP 13
Groundwater Monitoring Well Sampling - perfluoroalkyl substances (PFAS)
Introduction
This SOP describes the equipment, criteria, and procedures that will be used to sample
groundwater monitoring wells for PFAS compounds. These analytes require special sampling
and handling methods. Terracon will employ the “Clean Hands – Dirty Hands” protocol,
developed by the US EPA for sampling low level metals and can be used for other
contaminants that are analyzed in the parts per trillion range. Some deviations from this SOP
may be necessary because of site-specific conditions.
Equipment
In addition to the equipment listed in SOP 12, Groundwater Monitoring Well Sampling, the
following is a list of specific equipment for use when sampling for PFAS.
ITEMS TO BRING:
n High-density polyethylene (HDPE) tubing
n Clothing - 100% cotton (no use of dryer sheets)
ITEMS THAT CANNOT BE BROUGHT TO SITE:
n Rain gear
n Non-cotton fabrics
n food
n Anything marked as waterproof (ie notebook, Gore-tex boots)
n Aluminum foil
n Teflon-coated containers or lids
n Sunscreen
n Insect repellent
n Personal care products
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.
Step-by-step Procedures
Clean Hands (CH) / Dirt Hands (DH)
1. Before arriving onsite
a. Wash water level probe
b. Wash hands then put on nitrile gloves
c. Put ice in Ziploc bags then into coolers
2. Arrive onsite, Prep
a. Put on gloves – DH opens outer glove bag for CH, CH opens inner bag and
removes gloves
SOP 13-2
3. Equipment blank before sample first well
a. DH opens outer bag with sample tubing
b. CH opens inner bag with sample tubing, holds segment of tubing for DH to cut
c. DH connects tubing to pump
d. DH2 opens cooler, removes bag with sample bottles, opens outer sample bottle
bag
e. CH opens inner sample bottle bag, removes bottles
f. DH1 turns on pump
g. CH collects sample. Hold lids or keep in inner sample bag (do not place on ground)
4. Gauges well: DH gauge using deconned WLM and records info on groundwater sampling
form
5. To Purge Well:
a. DH stages pump next to well
b. DH opens outer bag with HDPE tubing
c. CH opens inner bag with sample tubing
d. CH handles tubing, puts down well (touching nothing but tubing), holds tubing for
DH to cut
e. DH cuts tubing
f. DH sets up water quality meter – probe in bucket, not connected to tubing
g. DH turns on pump, purges water into bucket, records readings on sample form
6. To Sample PFAS sample:
a. DH opens cooler, removes bag with sample bottles
b. DH opens outer sample bottle bag
c. CH opens inner sample bottle bag, removes bottles
d. CH collects sample, touching nothing but sample tubing and sample bottles. Hold
lids or keep in inner sample bag (do not place on ground)
e. CH fills out label on sample bottles
f. CH puts sample bottles in inner sample bag and zips bag closed
g. DH closes outer bag, opens cooler, places sample in cooler
7. Field Blank – follow sampling protocol. Only CH touch sample bottles and pours PFAS free
water
8. Fill remaining sample containers; CH/DH not applicable
.
SOP 14-1
SOP 14
Field Instrument Calibration
Introduction
This SOP describes the procedures for the use and calibration of the most commonly used
field instruments. The use and calibration procedures are provided for the following field
instruments:
n Photoionization detector/organic vapor monitor (PID/OVM)
n X-Ray Fluorescence (XRF) Multi-element Analyzer
Photoionization Detector
n Photoionization detector meter and filter screen
n Isobutylene span gas (100 ppm) and gas sample bag
Calibration Procedures
Calibration procedures will be performed, as specified by the manufacturer, each day prior to
use.
SOP 17-1
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 to document the decontamination procedures will be collected if
required in the sampling work plan.
SOP 20-1
SOP 20
Sample Handling and Documentation
Introduction
This SOP describes procedures to follow once soil, sediment, or water samples are collected to ensure
that the samples are handled properly and that appropriate documentation is completed.
Sample Handling
Chemical resistant gloves will be worn during collection and initial handling of all samples. All samples
will be promptly placed in an iced cooler to maintain a temperature of 4°C. Typically, samples selected
for chemical analysis are delivered at the end of each day to the analytical laboratory. If they are not
submitted to the laboratory on the same day collected, they will be stored in a refrigerator in a locked
sample storage room at Terracon’s office until transport and delivery to the laboratory in an iced cooler.
Upon receipt of the samples, the laboratory will record the internal temperature of the sample transport
coolers on the chain of custody record.
Documentation
Sample Identification and Labeling
Samples will be labeled following the specific labeling requirements set forth in the sampling plan or
using labeling methods that identify the area from which they were collected and the depth.
Each sample sleeve or sample container will be immediately labeled with the following information:
n Project number
n Sample identification
n Sample depth
n Date and time collected
n Analyses requested
n Filtered or unfiltered (for water samples)
This information will also be recorded in the field notebook. An example sample label is provided as an
attachment to this SOP
Chain of Custody
Chain of custody documentation will begin in the field for each sample submitted to the laboratory and
will be maintained by laboratory personnel. Samples will remain in the possession of the sampler at all
times, or in a locked facility until delivery to the analytical laboratory. A chain of custody form will be
completed and will accompany each sample cooler to the analytical laboratory. An example chain of
custody form is provided as an attachment to this SOP.
SOP 20-2
Field Book
Terracon field personnel will maintain a field log book to record all field activities. The field logbook will
be a weather-resistant bound survey-type field book. All data generated during the project and any
comments or other notes will be entered directly into the field logbook.
Example Sample Label:
Example Chain of Custody Form:
APPENDIX B
Laboratory Quality Assurance Manuals
Chemtech-Ford, Inc.
9632 South 500 West
Sandy, UT 84070
[phone]
Vice President of Quality: Paul Ellingson
Quality Manager: Ron Fuller
Laboratory Director: Dave Gayer
Date of Issue: October 1, 2017
Controlled Copy #: QM-27
Dave Gayer, Laboratory Director
Paul Ellingson, Vice President
Ron Fuller, QA Officer
Quality Manual
This Quality Manual meets the requirements of ISO 17025, ISO 9001, and TNI. This
Quality Manual is confidential and assigned as outlined below.
Original Document: Quality Manager
Controlled Copy
Uncontrolled Copy
All employees have access to a controlled version through Quality Manager, or through
the Chemtech-Ford intranet. Printed copies are not considered controlled documents.
Companies whose Quality Systems are defined by this document are:
Chemtech-Ford Laboratories
9632 South 500 West
Sandy, UT 84070
801.262.7299
Timpview Analytical Laboratories
1384 West 130 South
Orem, UT 84058
801.229.2272
This Quality Manual has been approved for use by affiliate laboratories of Chemtech-
Ford, Inc.
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Table of Contents
Introduction
1. Scope
2.Normative References
Reference List
Cross-references
3.Terms and Definitions
4.Management Requirements
4.1 Organization
4.2 Management System
4.3 Document Control
4.4 Review of Requests, Tenders, and Contracts
4.5 Sub-contracting of Tests and Calibrations
4.6 Purchasing Services and Supplies
4.7 Service to the Customer
4.8 Complaints
4.9 Control of Nonconforming Testing and Calibration work
4.10 Improvement
4.11 Corrective Action
4.12 Preventive Action
4.13 Control of Records
4.14 Internal Audits
4.15 Management Reviews
5.Technical Requirements
5.1 General
5.2 Personnel
5.3 Accommodation and Environmental Conditions
5.4 Test and Calibration Methods and Method Validation
5.5 Equipment
5.6 Measurement Traceability
5.7 Sampling
5.8 Handling of Test and Calibration Items
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5.9 Assuring the Quality of Test and Calibration Results
5.10 Reporting the Results
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Introduction
Purpose
This Quality Manual contains all the requirements that our laboratory uses to demonstrate
our quality management system, technical competence, and valid results.
Section 4 specifies how we demonstrate sound management and maintain client
satisfaction.
Section 5 specifies how we demonstrate technical competence in our laboratory.
In addition, this Quality Manual outlines how we meet:
ISO 17025
ISO 9001
TNI
All personnel are to take an active role in establishing, implementing, and maintaining
our quality management program. We do not separate quality from our daily business.
Quality is integrated into every facet of the decision-making process in the management
of our laboratory and the science that we practice.
It is the policy of Chemtech-Ford, Inc. and its employees to 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
co-workers, 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.
Chemtech-Ford, Inc. encourages its employees to demonstrate consistently ethical and
professional behavior by implementing programs consonant with that purpose. These
programs, generally, include:
1) a thorough training program for new employees and continuing seminars throughout
employment which reflect Chemtech-Ford, Inc.'s commitment to integrity and quality
control and which present specific ways to honor that commitment
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2) a comprehensive documentation program for all facets of laboratory operation, which
allows ready reconstruction of any quality process
3) a program of continual evaluation, both internally and externally, with required levels
of quality acceptance
4) a management monitoring system which routinely evaluates the overall performance of
the laboratory.
This Quality Manual summarizes the policies and procedures employed by Chemtech-
Ford, Inc. It is the purpose of these policies and procedures to maintain the highest level
of integrity and ethical behavior in all aspects of laboratory work.
Distribution List
The approved version of this manual is available to all employees through Quality
Manager and/or Chemtech-Ford Laboratories intranet. All printed copies are
uncontrolled.
In the event that a controlled copy of this manual is necessary, the Quality Manager will
maintain a distribution list.
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1. Scope
This Quality Manual facilitates:
Recognition of technical competence for standardized methods, non-routine methods,
and laboratory-developed methods we perform
Inspection and product certification capabilities and/or services we provide
Total quality for our administrative and technical systems
Audits by clients, regulatory authorities and accreditation bodies
Meeting the requirements of ISO 17025, ISO 9001, and TNI
Client satisfaction
Chemtech-Ford Laboratories displays all Fields of Accreditation on our website.
2. Normative References
Reference List
ISO/IEC 17000, Conformity assessment – Vocabulary and general principles
VIM, International vocabulary of basic and general terms in metrology, issued by BIPM,
IEC, IFCC, ISO, IUPAC, IUPAP and OIML.
ISO 9001:2000 – Quality Management Systems – Fundamentals and vocabulary.
ISO/IEC 17025:2005 – General Requirements for the Competence of Testing and
Calibration Laboratories.
TNI Standard, Volume 1, 2009 NELAC Standard.
Cross-references
This manual is numerically aligned with the international standard ISO 17025.
Furthermore, each section cross-references the ISO 9001 standard.
For ease of use, each section starts with a brief summation of what the section addresses
and a listing of the quality terminology and key words.
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3. Terms and Definitions
For the purposes of this manual, the following documents and their corresponding
definitions apply: ISO/IEC 17000; ISO/IEC Guide 30; ISO Council Committee on
Conformity Assessment (CASCO); ISO 9000; ISO 5725-1; ISO 17025; TNI 2009
Standard; AOAC; and International Vocabulary of Basic and General Terms in
Metrology (VIM).
Accreditation – formal recognition of a laboratory by an independent science-based
organization that the laboratory is competent to perform specific tests.
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4.1 Organization
Section Synopsis
This section tells you our laboratory has:
1. Appointed a Quality Manager
2. Organized the workforce to achieve quality
3. Provided adequate resources to ensure quality
Key Words
Quality Manager
Organizational Chart
Authority
Resources
Confidential Information
Proprietary Rights
Responsibilities
Conflict of Interest
Cross-references
ISO 17025:2005 Section 4.1
ISO 9001:2000 Section 4.1, 5.1, 5.3, 5.4.1, 5.5.1, 5.5.2, 5.5.3, 6.1, 6.2.1, 6.2.2,
6.3.1, 7.1, 7.5.4
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4.1.1 Legal Identification / Registration
Chemtech-Ford, Inc.
9632 South 500 West.
Sandy, UT 84070
[phone]
[phone]
4.1.2 Laboratory Requirements
The work area of Chemtech-Ford, Inc has been organized to satisfy the needs of the
customer and regulatory authorities and to meet the international standards TNI, ISO
17025 and ISO 9001. Chemtech-Ford, Inc. is composed of the following work areas:
President/CEO/Vice Presidents
Lab Director
QA/QC Department
Customer Service Department
Receiving/Shipping Department
Organics Lab
Inorganics Lab
Microbiology Lab
Metals Lab
4.1.3 Scope of Management System
The management system covers activities all of the laboratory’s facilities. The fields of
activities include:
Environmental Sample Testing
Medical Device Testing
Nutraceutical Product Testing
Specialty Testing
The laboratory’s scope of tests is listed in the current Price List.
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4.1.5 Organization
A) Management and Technical Personnel
Policy:
The laboratory managerial and technical personnel, irrespective of other responsibilities,
have the necessary authority and resources needed to meet the mandates assigned to their
areas.
Details:
Responsibilities are detailed in 5.2.5
Departures from the organizational and management policies in this manual can only be
approved by a Vice President.
Departures from quality management system procedures can only be approved by a Vice
President or the Quality Manager.
Departures from test methods or technical standard operating procedures (SOPs) can only
be approved by the Quality Manager and/or the Laboratory Director.
See also section 5.2.
B) Conflict of Interest
Policy:
Management and personnel are to be free from any 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 Laboratories performs annual data integrity training. A review of the undue
pressure policy is part of this training.
Details:
The following list provides some guidelines on how employees avoid conflict of interest
situations. Employees shall not:
falsify records, prepare fraudulent reports, or make false claims
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seek or use privileged or confidential company information, or data from any
customer, for any purpose beyond the scope of employment
conduct non-laboratory business on laboratory time, or use company facilities or
equipment to conduct outside interests in business, unless prior approval has been
obtained
solicit business on their own behalf (rather than the laboratory) from a customer
be employed by, or affiliated with, organizations whose products or services compete
with laboratory products or services
have employment that negatively affects or interferes with their performance of
laboratory duties
compete with the laboratory in the purchase, sale, or leasing of property or goods
allow association, family, or friends to influence business decisions to their benefit.
Decisions must be made on a strictly business basis, always in the best interest of the
laboratory
make any decision that provides gains or benefits to the employee and/or others
have personal financial dealings with an individual or company that does business
with the laboratory which might influence decisions made on the laboratory’s behalf
Firm adherence to this code of values forms the foundation of our credibility. Personnel
involved in dishonest activities are subject to a range of disciplinary action including
dismissal.
C) Customer Confidentiality
Policy:
It is the policy of our laboratory to protect the confidential information and proprietary
rights of our customer including the electronic storage and transmission of results.
Details and Procedures:
All employees sign a Confidentiality Agreement. The signed agreement is retained in
each employee’s Human Resources file.
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.
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D) Operational Integrity
Policy:
The laboratory will avoid involvement in any activities that would diminish confidence in
its competence, impartiality, judgment, or operational integrity.
Details and Procedures:
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 DOCs (Demonstration of Competency) reports. Impartiality
is assessed through audits and approvals. Judgment is ensured through the hiring of
qualified personnel and by continuously refining, upgrading, and improving his or her
skills. 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. Any problems are acted on immediately through
corrective action procedures.
E) Organizational Structure
Policy:
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 an organizational chart.
Details:
The most current organizational structure is contained within Quality Manager. The
organizational structure is reviewed at regular intervals (at least two times per calendar
year).
F) 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
5.2.5
G) Laboratory Supervision
Policy:
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Adequate supervision is provided in each area of the laboratory for all testing and
calibration personnel, including trainees, by persons familiar with the methods and
procedures.
Details:
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 analyses in the
commercial PT study program, and/or DOC studies are evidence of successful and
continued training.
H) Technical Management
Policy:
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.
Details:
While the technical manager may at times delegate duties to other personnel, the
technical manager is responsible for the work produced in his area of the laboratory, and
is accountable for any nonconforming activities.
I) Quality Manager
Policy:
The Quality Manager is appointed by the highest level of management. The Quality
Manager, who, irrespective of other duties and responsibilities, has defined responsibility
and authority for ensuring that 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.
Details:
This statement notifies all laboratory personnel that the Quality Manager is authorized by
senior management and the President to administer all activities relating to the Chemtech-
Ford Laboratories quality system. A formal announcement to the laboratory and
appropriate certification/regulatory authorities will be made if a change is made to the
person filling this position.
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J) Managerial Substitutions
Policy:
Deputies for key personnel are appointed to fulfill the key personnel’s duties in their
absence.
Details:
In the absence of the Lab Director, the Quality Manager or Deputy Lab Director will
assume his/her responsibilities.
In the absence of the Quality Manager, the Lab Director will assume his/her
responsibilities.
In the absence of the Laboratory Supervisor, the Lab Director, Deputy Lab Director
and/or Quality Manager will assume his/her responsibilities.
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.
K) Awareness
Policy:
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.
Details:
Supervisors review the details of each employee’s job description with the appropriate
employee and how the overall Quality Policy Statement (Section 4.2.2) relates to their
activities to achieve the objectives of the management system.
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4.1.6 Communication Processes
Policy:
Top management ensures that appropriate communication processes are established
within the laboratory and that communication takes place regarding the effectiveness of
the management system.
Details:
Management meetings are held regularly. Assignments and important communications
are made in this meeting. The appropriate manager communicates the assignment or
communication to their direct reports. These meetings are documented and follow-up
activities are recorded.
Revision History
Changes from Revision 26
Modified section 4.1.3 to include all of the facilities of the company rather than just the
main facility.
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4.2 Management System
Section Synopsis
This section tells you that our Management System (or Quality Management
System) is based on:
1. A well-defined quality policy statement
2. Say what you do through documentation
3. Do what you say following your documentation
4. Record what you did
Key Words
Establish, Implement, and Maintain
Policies, Systems, Processes, Programs, Procedures, Instructions
Communicate, Understand
Quality Policy Statement
Quality Manual
SOP
Test Method
Cross-references
ISO 17025:2005 Section 4.2
ISO 9001:2000 Section 4.1, 4.2.1, 4.2.2, 5.1, 5.3, 5.4.1, 5.4.2, 5.5.1, 5.5.2, 6.2.1,
7.1
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4.2.1 Policies and Procedures
Policy:
The Quality Management System is established, implemented, and maintained by
management. It is applicable to all the 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 results generated. These documents are communicated to, understood by,
available to, and implemented by the appropriate personnel.
Details:
The purpose of our 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.
The effectiveness of the Quality Management System is assessed in several ways:
by a program of planned internal audits, covering all aspects of the operation of the
quality management system
by regular management reviews of the suitability and effectiveness of the quality
management system
by analysis of potential and actual problems as shown by customer complaints and
supplier and subcontractor assessments
by other methods approved from time to time by the appropriate authority.
This Quality Manual and associated documents (including procedures) and records serve
as the quality plan for the laboratory. Other documents and records may include:
standard operating procedures (SOPs)
quality control plans in test methods
organizational charts
proposals
project management schemes
Equipment manuals
Reference methods
Regulations
Accreditation standards
Software
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4.2.2 Quality Policy Statement
Policy:
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
during management review. The Quality Policy Statement is issued under the authority of
the Senior Management on the effective date.
Quality Policy Statement:
To ensure accurate and timely analytical services and to continuously meet or exceed the
stated or implied expectations of our customers through day-to-day interactions.
Effective Date: February 15, 2016
a) 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 customers’ 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.
b) Standards of service include:
 Customer Satisfaction
 Accuracy
Timeliness
Compliance with applicable standards and procedures
Excellence in 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.
c) 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.
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d) Personnel: familiarize them with quality documentation and implement the policies
and procedures in their work.
e) Management is committed to complying with the applicable standards and regulations
(e.g. TNI, ISO, OGWDW etc.) and to continually improve the effectiveness of the
management system:the objective of this Quality Manual 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.
Additional objectives include:
to establish the level of the laboratory’s performance
to make test method changes to improve performance
to participate in proficiency testing or quality evaluation programs with peer
laboratories
to ensure that all personnel are trained to a level of familiarity with the quality
management system appropriate to the individual’s degree of responsibility
to improve and validate laboratory methodologies by participation in method
validation collaborative tests
to establish and report on quality savings
4.2.3 Commitment to the Management System
Policy:
Top management is committed to the development and implementation of the
management system and continually improving its effectiveness.
Details:
The results of the management system are regularly reviewed during management review
(see Section 4.15) and continual improvements are made as outlined in Section 4.10 –
Improvements.
4.2.4 Communication of Requirements
Policy:
Top management communicates to the organization the importance of meeting customer
requirements as well as statutory and regulatory requirements.
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Details:
In general, 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 Quality Manual
Policy:
This Quality Manual outlines the structure of the documentation used in the quality
management system. This Quality Manual makes reference to supporting procedures
including technical procedures and is maintained up to date.
Details:
This quality management system is structured in three tiers of documentation. The tiers
are as follows:
I. Quality Manual
II. Standard Operating Procedures and Test Methods
III. Records
For most customers, this Quality Manual and the associated documents form 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.
All of the above documents are controlled documents. Not all quality system documents
and procedures are maintained in this manual, rather some are referenced and located in
other documents. The following records and directive documents are contained or
referenced in the Quality Manual:
organizational chart (section 4.1.5.E)
identification of resources and management review (section 4.15.1)
job descriptions (section 5.2.4)
statistical techniques (section 5.9)
test reports (section 4.13.2 and 5.10)
identification of the laboratory’s approved signatures (section 5.10.2)
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laboratory’s scope of tests (section 4.1.3)
equipment inventory and records (sections 5.5.4 and 5.5.5)
calibration status indicators (section 5.5.8)
reference standards inventory (section 5.6.3)
verification records (section 5.9)
quality control plan / criteria for workmanship (section 5.4.1)
corrective action records (section 4.11)
preventive action records (section 4.12)
customer complaint records (section 4.8.1)
audit schedule and records (section 4.14.3)
procurement and subcontracting records (sections 4.6 and 4.5.4)
training records (section 5.2.5)
master list of documentation (section 4.3.2)
confidentiality agreements (section 4.1.5 C)
contract review (section 4.4.2)
validation of test methods (section 5.4.5)
facility floor plan (section 5.3.1)
4.2.6 Change Management
The roles and responsibilities for change management are outlined in QSP 4-2-6.
4.2.7 Technical Management and the Quality Manager
The roles and responsibilities for technical management and the Quality Manager are
outlined in section 5.2.5 of this manual.
Technical management ensures that section 5 of this manual is implemented and
maintained. The Quality Manager ensures that section 4 of this manual is implemented
and maintained.
4.2.8 Maintenance
Policy and Details:
Top management ensures that the integrity of the management system is maintained
when changes to the management system are planned and implemented.
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Revision History
Changes from Revision 24
Revision 25 is a significant revision with numerous additions, deletions and corrections.
These are not all documented in the revision history, rather all persons on the distribution
list are required to read the entire document.
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4.3 Document Control
Section Synopsis
This section tells you that Document Control involves:
1. Writing good procedures
2. Getting them to the users
3. Keeping procedures good
Key Words
Controlled Document
Master List
Unique Identification
Revise
Revision Number
Effective Date
Review and Approval
Obsolete
Archive
Hand-written changes
Cross-references
ISO 17025:2005 Section 4.3
ISO 9001:2000 Section 4.2.1, 4.2.3, 4.2.4
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4.3.1 Policies and Procedures
Policy:
The SOP#QSP 4-3-1 is used to control all quality management system documents
(internally generated and from external sources). These include documents of external
origin, such as regulations, standards, other normative documents, test and/or calibration
methods, as well as drawings, specifications, instructions, and manuals.
Details:
Document means any information or instructions including policy statements,
procedures, specifications, charts, text books, posters, notices, memoranda, software,
drawings, and plans. These may be in various media, whether hard copy or electronic and
they may be digital, analog, photographic or written.
The documents to be controlled include:
Quality Manual
Standard Operating Procedures and test methods
Forms
Standards
Software manuals
Reference methods and manuals
Equipment manuals
Applicable regulations/statutes
The control of data related to testing and calibration is covered in section 5.4.7. The
control of records is covered in section 4.13.
4.3.2 Document Approval and Issue
4.3.2.1 Review / Approval / Master List
Policy and Details:
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 (i.e.,
reviewed by personnel knowledgeable in the documented activity and then approved by
management). A master list can be obtained by viewing the lists located on the Chemtech
Quality Manager and the SOP database for performance based methods, or intranet under
the SOP section. The categories are divided by folders. Each folder has a hyperlinked list
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of the SOPs. A listing of document revision is posted on the announcement area of the
Chemtech Document Archive tab. A revision history is maintained. Documents are
formally reviewed periodically to ensure their continuing suitability.
4.3.2.2 Availability and Obsolete Documents
Policy and Details:
The master list shows the current status of all controlled documents. The master list
document is organized with the following information:
Document Title
Effective Date
Revision Number
Method Reference (if applicable)
Date of last review
Controlled documents are approved before issue.
The SOP# QSP 4-3-1 for 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 purposes are
suitably marked (i.e., “INACTIVE" and dated) and/or archived appropriately.
4.3.2.3 Identification
Policy and Details:
All quality management system documentation is identified by:
date of issue and/or revision number
page numbering
total number of pages (e.g., page 5 of 5)
issuing authority (i.e., reviewer approval)
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4.3.3 Document Changes
4.3.3.1 Review / Approval
Policy:
Changes to documents are reviewed and approved by the same function (i.e., personnel or
position) that performed the original review.
Details:
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.
The Quality Manual is reviewed annually by the Quality Manager. Records are kept of
this review.
Test methods and SOPs are reviewed on a biennial basis. Procedures for this are outlined
in SOP# QSP 4-3-1.
Obsolete documents are withdrawn, but are retained for archive purposes and clearly
labeled as obsolete.
4.3.3.2 Identification of Changes
Policy:
The nature of document changes is identified in the document.
Details:
As outlined in SOP# QSP 4-3-1.
In general, the nature of changes is identified in the document by changing the font color
to blue. Revision history is recorded at the end of the document.
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4.3.3.3 Amendments by Hand
Policy and Details:
Hand-written amendments to documents are permitted only by those personnel
authorized to do so (see section 4.1.5 A). Amendments are clearly marked, initialed, and
dated. A revised document is formally re-issued at the time of the annual review. For
further details refer to SOP# QSP 4-3-1.
4.3.3.4 Computerized Documents
Policy and Details:
The SOP# QSP 4-3-1 details how changes in documents maintained in computerized
systems are made and controlled.
Revision History
Changes from Revision 24
None
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4.4 Review of Requests, Tenders, and Contracts
Section Synopsis
This section tells you that you must:
1. Clearly understand customer requirements
Key Words
Requirements
Subcontractor
Request
Tender
Contract
Review
Cross-references
ISO 17025:2005 Section 4.4
ISO 9001:2000 Section 5.2, 6.1, 7.2.1, 7.2.2, 7.2.3
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4.4.1 Policies and Procedures
Policy:
Prior to the commencement of any services that fall within the scope of this Quality
System, Chemtech-Ford will ensure that the scope of the work is clearly defined and that
the objectives of the project can be met. In some cases, the requests are formalized
through a statement of work and signed contract. Other cases require less formalized
contracts. In all instances Chemtech-Ford formalizes a contract between the laboratory
and the client. The lab ensures that:
a)the customer requirements including the methods to be used are adequately defined,
documented and understood (see section 5.4.2)
b)the laboratory has the capability and resources to meet the requirements
c)the appropriate test method is selected and capable of meeting the customer’s
requirements (see section 5.4.2)
When practicable, any differences between the request or tender and the contract are
resolved before any work commences. Each contract must be acceptable by both the
laboratory and the customer.
Details:
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.
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.
All work orders at Chemtech-Ford Laboratories 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
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timely manner. If the customer does not reply in a timely manner, Chemtech-Ford
Laboratories 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.
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.
Typical types of contracts include:
approved service quotations
confidentiality agreements
 non-disclosure agreements
 sample submission requests
 memorandum of agreement
 memorandum of understanding
 research proposals and contracts
 verbal orders (oral agreements)
 activity plans
4.4.2 Records of Review
Policy:
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.
Details:
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 Laboratories interpretation of the request.
Chemtech-Ford Laboratories assumes that the request is accurate unless the client
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informs us otherwise. If there is a discrepancy, the change is noted and documented in
the LIMS or chain-of-custody.
Other work may demand more complex and formalized contract review. These contracts
are maintained by Chemtech-Ford Laboratories and the client. Formal contracts should
be stored in the project in LIMS. The LIMS project can be customized for most of the
project requirements such as pricing, analyte lists, reporting limits, QC limits, report
format, report recipients, etc.
When a formal contract is entered into between the lab and the client, the appropriate lab
member of management must sign the contract (usually the Vice President or their
designee). 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
Policy:
Request, tender, and contract review also includes work that is subcontracted by the
laboratory.
Details:
Subcontractor laboratories are reviewed as described in section 4.5. Performance based
methods developed by Chemtech-Ford Laboratories are not subcontracted.
4.4.4 Notification of Customer
Policy and Details:
Customers are informed of deviations from the contract. This is typically communicated
to the customer prior to the performing the deviation.
4.4.5 Contract Amendment
Policy and Details:
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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.
Revision History
Changes from Revision 24
Revision 25 is a significant revision with numerous additions, deletions and corrections.
These are not all documented in the revision history, rather all persons on the distribution
list are required to read the entire document.
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4.5 Subcontracting of Tests and Calibrations
Section Synopsis
This section tells you that we must:
1. Know what tests and calibrations need to be done by another laboratory
2. Check out the other laboratories
Key Words
Competence
Register of Subcontractors
Assessment
Cross-references
ISO 17025:2005 Section 4.5
ISO 9001:2000 Section 7.2.3, 7.4.1, 7.4.3, 8.2.4
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4.5.1 Subcontractor Competence
Policy:
Performance based methods developed by Chemtech-Ford Laboratories 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
contracts requiring some extra technical expertise
Details:
The subcontracted laboratory demonstrates technical competence by possession or receipt
of one or more of the following:
recognized technical accreditation (e.g. TNI, ISO, EPA etc.)
satisfactory performance of appropriate quality control check samples, certified
reference material, in-house reference material or replicate analysis
audit of the subcontractor’s quality management system by our auditors
It is the responsibility of the Quality Manager to assess and approve the competence level
of subcontractor laboratories. The approved subcontract laboratories are maintained in
Quality Manager.
4.5.2 Customer Approval
Policy:
Customers are advised of work (or any portion thereof) that is being subcontracted to
another laboratory and their approval is obtained (preferably in writing).
Details:
Customers are advised of subcontracted work through the contracting process (see 4.4).
4.5.3 Assurance of Subcontractor Competence
Policy:
If the laboratory selects the subcontracted lab, then the laboratory is responsible to the
customer for the subcontractor’s work. Technical competence of subcontractor
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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.
Details:
Records of subcontractor competence can include, but are not limited to, the following:
accreditation certificates or documentation
registration certificates
check sample results
audit results
approval by the Quality Manager
approval by the client
4.5.4 Subcontractor Register
Policy:
A register of all subcontractors performing tests and calibrations is maintained in Quality
Manager or within the project records.
Details:
The approved register of subcontractors is maintained by the applicable Accreditation
Body or in the project records.
Revision History
Changes from Revision 24
Revision 25 is a significant revision with numerous additions, deletions and corrections.
These are not all documented in the revision history, rather all persons on the distribution
list are required to read the entire document.
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4.6 Purchasing Services and Supplies
Section Synopsis
This section tells you that we must:
1. Know what we want
2. Check out our suppliers
Key Words
Selection
Verify
Specifications
History
Cross-references
ISO 17025:2005 Section 4.6
ISO 9001:2000 Section 6.3.1, 7.4, 7.5.5, 8.2.4
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4.6.1 Policies and Procedures
Policy:
The SOP# QSP 4-6-1 is used to select and purchase services and supplies. The SOP#
QSP 4-6-1 is used for procurement, reception, and storage of supplies.
Details:
Consumable materials are stored according to the appropriate test method, SOP, or work
instruction.
4.6.2 Specifications
Policy:
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.
Details:
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 or other appropriate area after the COA is checked to ensure the received item
meets minimum specifications.
Chemicals are purchased with manufacturer’s certificates where possible. Uncertified
chemicals are purchased from ISO 9000 registered companies. Whatever the source, the
laboratory verifies the quality of the standards by comparing the new batch of standards
to the old. Due regard is paid to the manufacturer’s recommendations on storage and
shelf life.
Reagents are generally purchased from manufacturers who have a quality management
system based on ISO 9000. The grade of any reagent used (including water) is stated in
the method together with guidance on any particular precautions to be observed in its
preparation or use.
Where no independent assurance of the quality of procured goods or services is available
or the supplier’s evidence is insufficient the laboratory ensures that purchased goods and
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services comply with specified requirements. Where possible and practical the laboratory
ensures that goods are inspected, calibrated, or are otherwise in compliance with any
standard specification relevant to the calibrations or tests concerned.
4.6.3 Purchasing Documents
Policy:
Purchasing requests are recorded on the Purchase Order form and contain data describing
the product ordered. The Purchase Order is reviewed and approved for technical content
prior to release.
Details:
The description may include type, class, grade, precise identification, specifications,
drawings, inspection instructions, other technical data including approval of test results,
quality required and quality management system standard under which they were
produced.
The completion of the Purchase Order is the responsibility of the originator or supervisor.
Either reviews the Purchase Order for accuracy and approve the technical content prior to
release with their signature and the date.
4.6.4 Approved Suppliers
Policy:
Suppliers of critical services are evaluated and approved before use. An approved
supplier list is maintained.
Details:
Audits or tender evaluation is conducted to qualify suppliers of critical services prior to
use. The criteria for evaluation may include, but is not limited to the following:
references
accreditation
formal recognition
The records are maintained by purchasing personnel.
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Revision History
Changes from Revision 24
Revision 25 is a significant revision with numerous additions, deletions and corrections.
These are not all documented in the revision history, rather all persons on the distribution
list are required to read the entire document.
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4.7 Service to the Customer
Section Synopsis
This section tells you that we must:
1. Facilitate clarification of the customer’s request
2. Give customer access to relevant testing area
3. Maintain customer contact
4. Inform customer of delays or deviations
5. Utilize customer surveys
Key Words
Clarification
Deviations
Delays
Customer Satisfaction Survey
Cross-references
ISO 17025:2005 Section 4.7
ISO 9001:2000 Section 6.1, 7.2.1, 7.2.3, 7.4.3, 7.5.1
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4.7.1 Service
Policy:
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.
Details and Procedures:
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.
Maintaining of open contacts. 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 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
Policy and Details:
The laboratory seeks feedback from the customer. Positive and negative feedback can be
obtained passively through ongoing communications with the customer (e.g., review of
test reports with customers) or actively through customer satisfaction surveys. The
feedback is used to improve the quality management system, testing activities, and
customer service.
One mechanism Chemtech-Ford Laboratories has established is a database that allows for
the entry of customer feedback (both positive and negative). The database categorizes
each item of feedback. When a laboratory representative receives feedback from a client
or other interested party, this should be reported in the database. When feedback requires
an action this is documented and assigned to the appropriate team member for review.
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Other mechanisms are in place to review customer feedback. During weekly
management meetings, customer feedback is reviewed (positive and negative).
Revision History
Changes from Revision 24
Revision 25 is a significant revision with numerous additions, deletions and corrections.
These are not all documented in the revision history, rather all persons on the distribution
list are required to read the entire document.
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4.8 Complaints
Section Synopsis
This section tells you that you must:
1. Maintain records of Complaints
2. Maintain records of Corrective Action
Key Words
Resolving
Investigation
Corrective Action
Follow-up Verification
Cross-references
ISO 17025:2005 Section 4.8
ISO 9001:2000 Section 7.2.3
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4.8.1 Policies and Procedures
Policy:
The SOP#QSP 4-8-1 is used for resolving complaints received from customers or other
parties. Records are maintained of all complaints and follow-up.
Details:
Records of complaints include the following information:
description of the complaint
investigation
corrective action (if necessary)
solution notes and date
follow-up verification
issuance level
See also section 4.11.
Revision History
Changes from Revision 24
Revision 25 is a significant revision with numerous additions, deletions and corrections.
These are not all documented in the revision history, rather all persons on the distribution
list are required to read the entire document.
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4.9 Control of Nonconforming Testing and Calibration Work
Section Synopsis
This section tells you that you must:
1. Stop testing when nonconforming work is identified
2. Determine what is causing nonconforming work
Key Words
Nonconforming
Root Cause
Cross-references
ISO 17025:2005 Section 4.9
ISO 9001:2000 Section 5.5.1, 7.4.3, 7.5.1, 8.2.4, 8.3, 8.5.3
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4.9.1 Procedures to Control Nonconforming Work
Policy:
The SOP#QSP 4-9-1 is used to control any aspect of testing and/or calibration work, or
the results of this work, when they do not conform with the test methods or the agreed
requirements of the customer.
Details:
The procedure ensures that:
Responsibilities and authorities for the management of nonconforming work are
designated and actions (including halting of work and withholding of test reports as
necessary) are defined and taken into consideration when nonconforming work is
identified
an evaluation of the significance of the nonconforming work is made
correction is taken immediately, together with any decision about the acceptability of
the nonconforming work
where necessary, the customer is notified and the work is recalled
the responsibility for authorizing the resumption of work is defined
Identification of nonconforming work or problems with the quality management system
or with testing activities can occur at various locations within the quality management
system and technical operations such as:
customer complaints
quality control
instrument calibration
checking of consumable materials
staff observations or supervision
test report checking
management reviews
internal or external audits
4.9.2 Root Cause Analysis
Policy:
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
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taken by participating personnel are to be reflected on the corrective action form. The
QM directs this process and retains all documentation within the appropriate files for
future reference. These corrective action documents will be stored for five years.
Details:
The SOP# QSP 4-11-1 outlines the recording of the root cause analysis for investigating
nonconforming work.
Situations warranting 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
Revision History
Changes from Revision 24
Revision 25 is a significant revision with numerous additions, deletions and corrections.
These are not all documented in the revision history, rather all persons on the distribution
list are required to read the entire document.
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4.10 Improvements
Section Synopsis
This section tells you that you must:
1. Review procedures for improvements
2. Continually implement improvements
Key Words
Continually
Effectiveness
Analysis of data
Cross-references
ISO 17025:2005 Section 4.10
ISO 9001:2000 Section 6.1, 8.1, 8.2.1, 8.4, 8.5.1
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4.10.1 Policies and Procedures
Policy:
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.
Details:
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.
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.
Inputs for improvement opportunities may be obtained from the following sources:
customer satisfaction surveys and any other 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 from process and service characteristics and their trends
Opportunities for improvement may also be identified on a special project basis. The
following are listed only as examples:
improving usefulness of bench space
reducing excessive inspection/testing
reducing excessive handling and storage
reducing test/calibration failures
Opportunities for improvement from daily feedback on operational performance (i.e.,
internal audits, customer feedback, test/calibration failures) are evaluated by the
Technical or Quality Manager. Typically, they are implemented through the corrective
and preventive action system.
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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. The process for this
evaluation is described in Section 4.15. Longer-term improvement projects are initiated
through the management review process, as well as the corrective and preventive action
system.
Service improvement opportunities are evaluated by management. They are implemented
through the supervisor of the laboratory who ensures that the improvements are validated
as outlined in Section 4.12 of this manual and appropriate level of quality control is
performed on an ongoing basis.
Revision History
Changes from Revision 24
Revision 25 is a significant revision with numerous additions, deletions and corrections.
These are not all documented in the revision history, rather all persons on the distribution
list are required to read the entire document.
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4.11 Corrective Action
Section Synopsis
This section tells you that you must:
1. Identify problems
2. Determine why the problem occurred
3. Fix the cause of the problem
4. Verify that your changes worked
Key Words
CAR
Root Cause
Monitor
Audit
Nonconforming work
Cross-references
ISO 17025:2005 Section 4.11
ISO 9001:2000 Section 5.5.1, 5.5.2, 8.1, 8.2.2, 8.2.3, 8.4, 8.5.2, 8.5.3
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4.11.1 General
Policy:
The SOP# QSP 4-11-1 is utilized for implementing corrective action when
nonconforming work or departures from policies and procedures in the quality
management system or technical operations have been identified. The procedure requires
that appropriate authority be designated for the implementation of corrective actions and
includes cause analysis, selection and implementation of corrective action, and
monitoring of actions.
Details:
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.
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
Policy:
Corrective action always begins with an investigation to determine root cause(s) of the
problem (see SOP# QSP 4-11-1).
Details:
Potential causes of the problem could include customer requirements, the samples,
sample specifications, methods and procedures (see 4.11.6), personnel skills and training,
consumable materials, or equipment and its calibration.
4.11.3 Selection and Implementation of Corrective Actions
Policy and Details:
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
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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 Action
Policy:
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.
Details:
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
Policy:
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.
Details:
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.
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4.11.6 Responsibility
Policy:
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.
Details:
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 Laboratories employees can recommend
corrective action. If it is determined that the problem merits corrective action, the
Quality Manager will initiate the corrective action.
Revision History
Changes from Revision 24
None
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4.12 Preventive Action
Section Synopsis
This section tells you that you must:
1. Identify potential problems
2. Determine why the problem could occur
3. Fix the cause of the potential problem
4. Verify that your changes worked
Key Words
PAR
Potential Nonconformity
Action Plan
Cross-references
ISO 17025:2005 Section 4.12
ISO 9001:2000 Section 4.2.4, 6.3.1, 8.4, 8.5.1, 8.5.2, 8.5.3
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4.12.1 Preventative Action Identification
Policy:
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.
Details:
Records of preventive action include the following information:
details of potential nonconformities
investigation
preventive action
follow-up verification
4.12.2 Preventive Action Plans
Policy:
The preventive action procedure includes the initiation of such actions and application of
controls to ensure that they are effective.
Details:
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.
Preventive actions can be designated and documented in the Corrective Action database
or in management meeting notes or other approved laboratory mechanism for
recording/monitoring preventive actions.
Revision History
Changes from Revision 24
Revision 25 is a significant revision with numerous additions, deletions and corrections.
These are not all documented in the revision history, rather all persons on the distribution
list are required to read the entire document.
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4.13 Control of Records
Section Synopsis
This section tells you that you must:
1. Identify the records to be kept
2. Keep identified records in a useful state
3. Destroy records when they are no longer needed
Key Words
Collection
Indexing
Access
Storage
Maintenance
Disposition
Legible
Traceable
Retrievable
Secure
Cross-references
ISO 17025:2005 Section 4.13
ISO 9001:2000 Section 4.2.4, 6.3, 6.4, 7.1, 7.5.1, 7.5.2, 7.5.3, 8.1, 8.2.2, 8.2.3,
8.2.4
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4.13.1 General
4.13.1.1 Procedures
Policy:
The SOP#QSP 4-13-1 is used to identify, collect, index, access, file, store, maintain,
protect, backup, and dispose quality and technical records. Quality records include
reports from internal audits and management reviews as well as corrective and preventive
action records.
Details:
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 electronically
or physically), and in confidence to the customer. Records are maintained in the
designated archival area for five (5) years.
4.13.1.2 Record Integrity
Policy:
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.
Details:
The retention times for records are generally set at five (5) years. Records may be in the
form of any type of media, such as hard copy or electronic media.
4.13.1.3 Record Security
Policy:
All records are held secure and in confidence.
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Details:
Access to records is secured through locked rooms, filing cabinets, passwords.
4.13.1.4 Record Backup
Policy:
The SOP# QSP 4-13-1 is followed to protect and backup data/records held on computers
at all times and to prevent unauthorized access to or amendment of data/records on
computers.
Details:
Data is password protected.
Backups ensure integrity and availability of data/information in the event of a
system/power failure.
4.13.2 Technical Records
4.13.2.1 Record Information
Policy:
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.
Details:
Technical records are accumulations of data (see 5.4.7) 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
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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.
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 # or lot #, 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 Recording
Policy:
Observations, data, and calculations are clearly and permanently recorded and
identifiable to the specific job at the time they are made.
Details:
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 Corrections to Records
Policy:
Changes to test data are made so as not to obscure or delete the previous data entry.
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Details:
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.
4.13.2.4 Transfer of records
Policy:
Records will be maintained or transferred in the event that a laboratory transfers
ownership or goes out of business.
Details:
In the event that the laboratory changes 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.
Revision History
Changes from Revision 24
Revision 25 is a significant revision with numerous additions, deletions and corrections.
These are not all documented in the revision history, rather all persons on the distribution
list are required to read the entire document.
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4.14 Internal Audits
Section Synopsis
This section tells you that:
1. Trained internal auditors examine your internal operations for quality
2. Auditors report the results to those in charge
3. You must correct any areas that need fixing
Key Words
Schedule
Elements
Independent
Nonconformity
CAR
Cross-references
ISO 17025:2005 Section 4.14
ISO 9001:2000 Section 8.1, 8.2.2, 8.2.3
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4.14.1 Internal Audit Program
Policy:
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 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.
Details:
The tracking of internal audit results is maintained in Quality Manager. The frequency is
also 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 (see also 4.11.5). 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.
Generally, the types of audits include:
quality management system
technical methods
products, services, and reports
4.14.2 Corrective Action
Policy:
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 if investigations show that laboratory results may have been
affected.
Details:
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
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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.
4.14.3 Records and Management
Policy:
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.
Details:
A report is prepared by the auditors and distributed to those audited and/or the area
manager/supervisor within an appropriate and agreed timeline. The audit report may
include the following sections, as appropriate:
audit objective and scope
area or section audited
personnel involved – auditors and auditees
date of audit
reference documents
observations including nonconformities and commendations
opening and closing meetings
recommendations
audit report distribution
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 kept in the
laboratory.
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4.14.4 Follow-up Audits
Policy:
Follow-up audits are performed to verify and record the implementation and
effectiveness of the corrective action taken.
Details:
The follow-up audit is performed at a mutually acceptable time between the area
implementing corrective action and the auditor. This time is determined when the CAR is
issued.
Revision History
Changes from Revision 24
Revision 25 is a significant revision with numerous additions, deletions and corrections.
These are not all documented in the revision history, rather all persons on the distribution
list are required to read the entire document.
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4.15 Management Reviews
Section Synopsis
This section tells you that management must:
1. Periodically review technical competence and customer satisfaction
2. Keep records of reviews
3. Ensure follow-up is executed
4. Measure progress
Key Words
Supervisor Reports
Audit Reports
CAR / PAR
Proficiency Results
Customer Satisfaction Survey
Resources
Cross-references
ISO 17025:2005 Section 4.15
ISO 9001:2000 Section 5.1, 5.4.2, 5.6, 6.2.1, 7.1, 8.5.1
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4.15.1 Review of Quality Management System and Testing
Policy:
Top management periodically (at least annually) and in accordance with a predetermined
schedule and SOP# QSP 4-15-1, 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.
Details:
The review takes account of:
suitability of policies and procedures (including the Quality Policy outlined in this
manual)
reports from managerial and supervisory personnel
the outcome of recent internal audits
corrective and preventive actions
assessments by external bodies
results of inter-laboratory comparisons or proficiency tests
changes in the volume and type of work undertaken
feedback from customers, including complaints and customer satisfaction surveys
recommendations for improvement
other relevant factors, such as quality control activities, resources and personnel
training
A minimum period for conducting a management review is once a year. Results of the
review feed into the laboratory planning system and include goals, objectives and action
plans for the coming year.
A management review can be supplemented by consideration of related subjects at
regular management meetings.
4.15.2 Findings, Actions, and Records
Policy and Details:
Findings from management reviews and the actions that arise are recorded in the minutes
of the meeting. Management will ensure that the actions are discharged within an
appropriate and agreed upon timeline.
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Revision History
Changes from Revision 24
Revision 25 is a significant revision with numerous additions, deletions and corrections.
These are not all documented in the revision history, rather all persons on the distribution
list are required to read the entire document.
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5.1 General
Section Synopsis
This section informs you that:
1. Many factors contribute to the correctness and reliability of tests and/or
calibrations
2. The laboratory must account for these factors
Key Words
Correctness
Reliability
Uncertainty
Cross-references
ISO 17025:2005 Section 5.1
ISO 9001:2000 Section 7.1, 7.5.1
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5.1.1 Correctness and Reliability
Policy and Details:
Correctness and reliability of the tests and/or calibrations performed have many
contributing factors including:
Human factors (see section 5.2)
Accommodation and environmental conditions (see section 5.3)
Test and calibration methods and method validation (see section 5.4)
Equipment (see section 5.5)
Measurement traceability (see section 5.6)
5.1.2 Measurement Uncertainty
Policy:
When developing test and calibration methods and procedures, total measurement
uncertainty must be accounted for in the training and qualification of personnel, and in
the selection and calibration of equipment.
Details:
The extent to which the factors contribute to total measurement uncertainty differs
between tests, matrices, methodologies.
See section 5.4.6 for more details.
Revision History
Changes from Revision 24
Revision 25 is a significant revision with numerous additions, deletions and corrections.
These are not all documented in the revision history, rather all persons on the distribution
list are required to read the entire document.
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5.2 Personnel
Section Synopsis
This section tells you that management:
1. Analyzes training needs
2. Provides training to employees for them to do their jobs
3. Qualifies people performing specific tasks
Key Words
Competence
Qualification
Authorize
Training Needs
Job Description
Registry of Skills
Cross-references
ISO 17025:2005 Section 5.2
ISO 9001:2000 Section 5.5.1, 6.2.1, 6.2.2, 7.5.1, 7.5.2
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5.2.1 Competence and Qualification
Policy:
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.
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.
Details:
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:
5.2.1.1 Laboratory Director – The minimum requirements for the technical director are:
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 Laboratories 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.
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
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addition, the person shall have one (1) year of experience in microbiological
analyses.
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.
5.2.1.2 Quality Manager - The minimum requirements for the quality manager are:
Bachelor’s degree and 2 years of experience in environmental laboratory
analysis/operation or an associate’s degree and 4 years of experience in
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 Supervisor - The minimum requirements for a laboratory supervisor are:
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.
The supervisor must demonstrate competency to supervise testing in the areas
over which they supervise.
5.2.1.4 Technical Employees - The minimum requirements for technical laboratory
employees vary as to position and job requirements. The education requirements
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differ based on the job assignments. In general, the requirements are:
A bachelors degree in the biological, chemical, or physical sciences from an
institution of higher education; or
An associates degree in the biological, chemical, or physical sciences from an
institution of higher education; or
A high school degree.
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
Policy:
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. SOP# QSP 5-2-1 is utilized to identify training needs and providing the
necessary training for personnel.
Details:
The skills and knowledge are defined in the job description for each job function as
described in section 5.2.1. Management compares the job description to the skills and
knowledge of the new incumbent to determine the training needs.
5.2.2.1 QA Program - Chemtech-Ford, Inc. provides easy access to controlled copies of
this “quality assurance program” as written within this document for all employees
of this laboratory.
5.2.2.2 Training Files - Chemtech-Ford, Inc. maintains training files for all employees
involved with data generation and reduction. The training files contain the
following sub-files:
Job description (minimum qualifications, experience, and skills
defined).
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Analytical qualification documentation “Demonstrations of
Capability,” (DOC’s). DOCs are neither appropriate nor required
for the analyses of Odor, Color, and Paint Filter Test. Also
alternatively, duplicate checks of capability are performed for
Dissolved Oxygen, Flashpoint, and all microbiological analyses.
Training attendance sheets.
SOP reading documentation.
Certificates, degrees, etc.
Signed “Ethics Statement.”
Training in the laboratory must include all methods or parts of methods and techniques
that personnel are asked to perform. 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.
5.2.3 Employees
Policy:
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.
Details:
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
Policy:
Current job descriptions for managerial, technical and key support personnel involved in
tests and/or calibrations are maintained centrally in the administration area of the
laboratory.
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Details:
Minimum contents of job descriptions include:
The duty of performing tests.
The act of planning tests and evaluation of results.
The responsibility of developing and validating new methods as / when requested.
Expertise and experience.
Qualifications and training programs.
Managerial duties.
5.2.5 Key Personnel and Responsibilities
Policy:
Chemtech-Ford, Inc. complies with the managerial staff requirements as identified and
required by “Utah Rule R444-14-8.”
Details:
Key Personnel include the following listed positions:
5.2.5.1 Authority and Interrelationships – The laboratory has designated the following
lines of authority:
CEO
President – Reports to CEO
Executive Vice President reports to President
Vice President, Quality Manager, Laboratory Director report to Executive
Vice President
Deputy Lab Director report to Lab Director
Section Manager reports to Lab Director or Deputy Lab Director
Team Leader reports to Section Manager
Analysts & Technicians report to Team Leader
These lines of authority may have exceptions (e.g. there may not be a Team Leader and
the analyst/technician may report to a Section Manager. The organizational chart is
reviewed and updated (as needed) at least semi-annually (or more frequently as needed).
5.2.5.2 Laboratory Director - The Laboratory Director is responsible for the
administrative oversight and overall technical operation of the laboratory. The
laboratory director will:
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Define minimum qualifications, experience, and skills necessary for all
technical employees.
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.
Review the Quality Managers audit findings and document such reviews.
Oversee laboratory technical and support staff.
Review and approve all new and existing analytical procedures.
Review and approve all deviations from normal analytical protocols.
Review external and internal quality control audits and all other relative
documentation/information.
Perform final review and approval of new laboratory projects including
reports and documents.
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.
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.
Ensure that subcontracted laboratories are capable and appropriately
certified for analytical work sent to them.
5.2.5.3 Quality Manager (QM) - The QM reports directly to the executive team. The QM
has the responsibility for the quality system and its implementation (See Section 6
of the QM). The Quality Assurance Officer will:
Have direct access to the highest level of management at which decisions
are taken on laboratory policy and resources, and to the laboratory director.
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Serve as the focal point for quality assurance and oversee and review quality
control data.
Have functions independent from laboratory operations for which he or she
has quality assurance oversight.
Have documented training or experience in quality assurance procedures
and be knowledgeable in the quality assurance requirements of Utah Rule
R444-14; also be knowledgeable in the quality systems.
Have knowledge of the approved methods used by the laboratory in order
to accurately evaluate laboratory performance.
Objectively evaluate data and objectively perform assessments without
undue influence.
Oversee all quality aspects of sample handling, testing, and report
generation.
Schedule, oversee, and be responsible for reviews of the entire technical
operation of the laboratory. This includes conducting annual technical
audits.
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.
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).
Serve as the back-up to the Laboratory Director in the absence of the
Laboratory Director.
5.2.5.4 Laboratory Area Supervisors - These managers are responsible for the day-to-
day operation of the laboratory. Their responsibilities include:
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Supervise all technical and non-technical employees.
Be responsible for the production and quality of all data reported by the
laboratory.
Review and approve analytical data generated within the area.
Develop and submit new methods and operating procedures for approval by
the Laboratory Director.
Evaluate instrument and personnel needs.
Ensure that all samples are accepted, analyzed, and reported in accordance
with laboratory SOPs.
5.2.5.5Technical Staff - Technical personnel, generally, are responsible for the routine
receipt, analysis and reporting of all laboratory samples. The technical staff will:
Report directly to the assigned supervisor.
Perform duties in accordance to laboratory policy and procedures.
Read, understand, and follow the Quality Manual and all appropriate SOPs.
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5.2.6 Laboratory Organizational Chart
The official organizational structure is contained in Quality Manager.
5.2.7 Staff Management Policies
Policy:
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.
Details:
5.2.7.1 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 of laboratory procedures and
analytical results to clients, regulatory agencies, and other interested parties. All
employees should understand that analytical data legally belongs to the client
who contracted such work.
5.2.7.1.1 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.
5.2.7.1.2 E-mail and FAX Correspondence
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Similar guidelines to 5.2.7.1.1 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.
5.2.7.1.3 "In-Person" Requests
Similar guidelines to 5.2.7.1 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.
5.2.7.1.4 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.
5.2.7.2 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 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.
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Serious violations of Chemtech-Ford, Inc.'s ethical policy include, but are not
limited to, the following:
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; and
Willfully circumventing the sample disposal Standard Operating Procedure.
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.
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 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.
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.
Furthermore, management will institute internal proficiency testing (blind and
double blind samples) where applicable; QC meetings whose emphasis is on
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appropriate and inappropriate laboratory technique and instrument/data
manipulation will be held routinely to address this topic.
5.2.7.2 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 (e.g. for unusual tailing due to matrix
effect).
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.
5.2.7.3 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.
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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:
5.2.7.3.1 The employee may report the source of the pressure(s) affecting lab
performance to his or her supervisor, or to the laboratory director or
owner if the employee believes notifying the supervisor will be
ineffective or problematic; and/or
5.2.7.3.2 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.
5.2.7.4 Validation of Employee Qualifications
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.
Each new employee is required to read, sign, and understand a
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. This
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.
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.
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Demonstrations of Capability for all technical competencies
required.
An explanation of the Chemtech-Ford, Inc. Laboratory Information
Management System (LIMS) and its functions.
New employees are apprised of all laboratory security systems and the
Training Files to be kept by each employee.
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.
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.
Records are held in Quality Manager.
Revision History
Changes from Revision 24
Revision 25 is a significant revision with numerous additions, deletions and corrections.
These are not all documented in the revision history, rather all persons on the distribution
list are required to read the entire document.
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5.3 Accommodation and Environmental Conditions
Section Synopsis
This section tells you:
1. That laboratory facilities are suitable for attaining correct performance of tests
and calibrations
2. Critical environmental conditions are monitored, controlled and recorded
3. Incompatible activities are separated
4. Access to laboratories is controlled
5. Good housekeeping is practiced
Key Words
Incompatible activities
Prevent cross-contamination
Controlled access
Cross-references
ISO 17025:2005 Section 5.3
ISO 9001:2000 Section 6.3, 6.4, 7.1, 7.5.1, 7.5.2, 7.6, 8.2.3
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5.3.1 Facility
Policy:
Laboratory facilities shall be 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.
Details:
This section deals with the test areas in the laboratory and premises for support such as
sample receipt and storage. 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
Policy:
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.
Details:
Laboratories are ventilated to reduce the levels of contamination, lower humidity, and
control temperature. Laboratories’ test areas are air-conditioned and the temperature is
20-25 °C.
Bench tops and floors are made of impervious, smooth easily cleaned materials. There is
at least two linear meters workspace per analyst while working. Walls and ceilings are
made of materials that are smooth and easily cleaned.
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5.3.3 Separation of Incompatible Activities
Policy:
Effective separation between neighboring areas is made when the activities are
incompatible. Measures are taken to prevent cross-contamination.
Details:
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
Policy:
Access to and use of areas affecting quality of the tests is defined and controlled.
Details:
Access to the laboratory is restricted to authorized personnel only. The authorized
personnel are made aware of the following items:
the intended use of the area
the restrictions imposed on working within such areas
the reasons for imposing the restrictions
5.3.4.1 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.
5.3.4.2 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. As with the main laboratory, access to this building
is limited to authorized personnel only. All GC/MS volatiles work is performed in
this area.
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5.3.4.3 Inorganic Chemistry Laboratory - The inorganic chemistry laboratory occupies
the largest of the lab area within the building. The area 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.
5.3.4.4 Wet Chemistry Laboratory - This laboratory is adjacent to the inorganic chemistry
laboratory and contains the necessary equipment required to perform various wet
chemistries (e.g., BOD, COD, and TSS).
5.3.4.5 Metals Laboratory - The metals analysis laboratory contains all of the metals
analytical equipment. However, samples are prepared for metals analysis in the
inorganic laboratory, thus reducing the possibility of instrument contamination. The
metals laboratory is designed for ICP, ICP/MS, and Hg cold-vapor instrumentation.
5.3.4.6 GC and Semi-Volatile GC/MS Laboratory - The preparation lab contains standard
fume hoods and ample bench space for sample extraction. The GC and Semi-volatile
GC/MS instrument laboratory has several benches with GC and GC/MS
instrumentation and supplies.
5.3.4.7 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.
5.3.4.8 Sample Storage - Samples remaining in the sample analysis stream are located
within their respective holding areas (refrigerators, etc.) until required analyses
have been complete. Additional post-analysis storage for metals-preserved sample
bottles is accomplished via storage shelves located within the metals laboratory.
All other inorganic/organic samples are kept for a maximum of three months
(following data reporting) in refrigerated storage throughout the laboratory.
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5.3.5 Good Housekeeping
Policy:
Measures are taken to ensure good housekeeping in the laboratory. Special procedures
are followed when necessary.
Details:
Controlled use of cleaning and pest control materials is exercised. The laboratory
complies with the local health and safety requirements.
Revision History
Changes from Revision 25
Section 5.4.5.3 Title edited for grammar.
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5.4 Test Methods and Method Validation
Section Synopsis
This section tells you:
1. Preference is given to the use of a standard method when selecting
procedures
2. All methods must be validated before use
3. Measurement uncertainty is estimated
4. Data is controlled
Key Words
Standard Methods
Laboratory-Developed Methods
Non-standardized Methods
Validation
Uncertainty of Measurement
Data Checks
Cross-references
ISO 17025:2005 Section 5.4
ISO 9001:2000 Section 4.2.1, 4.2.3, 6.1, 6.3, 6.4, 7.1, 7.2.1, 7.2.2, 7.3, 7.4.3,
7.5.1, 7.5.2, 7.6, 8.1, 8.2.3, 8.2.4
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5.4.1 General
Policy:
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/or
calibrated
an estimation of the measurement of uncertainty as well as statistical techniques for
analysis of test and/or calibration data where appropriate
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.
Details:
There are SOPs for sample handling, storage, preparation of test items, QA/QC
procedures (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. The content of an environmental
(TNI) test method should include:
Applicable Matrices
Detection Limit
Method Scope
Method Summary
Definitions
Interferences
Safety
Equipment and Supplies
Reagents and Standards
Sample Collection, Preservation, Shipment and Storage
Quality Control
Calibration and Standardization
Procedure
Calculations
Method Performance
Changes to the Approved Method
Data Assessment and Acceptance Criteria
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Corrective Action & Contingencies for Out of Control Data
Pollution Prevention and Waste Management
References
Editorial Changes to SOP
Appendices
International, national, or regional standards or other recognized specifications that
contain sufficient and concise information on how to perform the tests and/or calibrations
are not necessarily supplemented or rewritten as an internal procedure when they are
written in a way that can be used as published by laboratory staff. Consideration may
need to be given to providing additional documentation for optional steps in the method.
5.4.2 Selection of Methods
Policy:
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 used unless it is not
appropriate or possible to do so. When necessary, the standard is supplemented with
additional details to ensure consistent application.
Details:
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. Methods may be adopted from but are not limited to the following
sources: EPA, Standard Methods, USP, AOAC, FDA BAM, USDA FSIS & AMS,
APHA SMEDP, APHA, AWWA, WEF, NELAC, TNI, Compendium of Methods for the
Microbiological Examination of Foods, ISO, ICMSF, National Food Processors,
American Association of Cereal Chemists, Association of Dressing and Sauces, Health
Canada, Environmental Protection Agency, OIE, and ASTM.
The ability of the laboratory to achieve satisfactory performance against documented
performance characteristics is verified before samples are analyzed.
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
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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.
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
Policy:
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.
Details:
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.
5.4.4 Non-Standard Methods
Policy:
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.
Details:
Discussion and agreement for the use of non-standard methods is recorded as part of
contract review procedures (see section 4.4).
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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Quantitative test methods are validated to demonstrate specificity, sensitivity, relative
accuracy, positive and negative deviation, repeatability, reproducibility, and limit of
determination.
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.
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:
appropriate identification
scope
description of the type of item to be tested or calibrated
parameters or quantities to be determined
apparatus and equipment, including technical performance requirements
reference standards and reference materials required
environmental conditions required and any stabilization period needed
description of the procedure, including:
affixing identification marks, handling, transporting, storing and preparing of
items
ensuring checks are made before the work is started
checking that the equipment is working properly and, where required, calibrating
and adjusting the equipment before each use
listing method of recording the observations and results
indicating any safety measures to be observed
criteria and/or requirements for approval/rejection (quality control plan)
data to be recorded and method of analysis and presentation
uncertainty or procedure for estimating uncertainty
5.4.5 Validation of Methods
5.4.5.1 Performance Characteristics
Policy:
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.
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Details:
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
quality control incorporating statistics as applicable
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.
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
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confirm their significance. In all cases, the reasons for choosing one or more alternatives
must be documented.
analysis of standard reference materials (SRM) that are identical or almost identical to
the test samples
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
using an alternative method to measure the same parameter provides a very high level
of confidence if results are confirmed
recovery studies by the addition of a known concentration of the parameter of interest
to some of the replicates being measured
The parameters to be determined include:
the scope of the method and any known interference
detection limit
the range of concentration where the method is valid
precision and bias
Judgment 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.
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.
Records are kept on all validation activities. The records include any of the performance
characteristics chosen, reference procedures or guidance documents followed to validate
the method or custom validation procedure, and a final confirmation (memo to file) that
the method validation results are acceptable for continued use of the method. An example
statement would be “This serves as record that the validation of the XYZ Test Method
has been approved for use by [name and title of approver]”.
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5.4.5.2 Fit for Use
Policy:
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 (may include procedures for sampling, handling, and transportation). 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.
Details and Procedure:
Validation records are kept as in section 5.4.5.1. 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.
The techniques used for the determination of the performance of a method, are one of, or
a combination of, the following:
calibration using reference standards or reference 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
Policy:
The range and accuracy of the values obtainable from validated methods (e.g., the
uncertainty of the results, detection limit, selectivity of the method, linearity, limit of
repeatability and/or reproducibility, robustness against external influences and/or cross-
sensitivity against interference from the matrix of the sample/test object) as assessed for
the intended use is relevant to the customer’s needs.
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Details:
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 Uncertainty of Measurement
5.4.6.1 Calibration
Policy:
Physical, chemical, and biological standards are calibrated or characterized by qualified
subcontractors.
Details and Procedures:
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.
Note – in-house calibrations include procedures for uncertainty of measurement
estimates where practicable.
5.4.6.2 Testing
Policy:
The SOP#QSP 5-4-1 is utilized to estimate uncertainties of measurement in testing,
except when the test methods preclude such rigorous calculations. 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
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knowledge of the performance of the method and on the measurement scope and makes
use of previous experience and validation data.
Details:
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
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 (see section 5.10).
5.4.6.3 Uncertainty Components
Policy:
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.
Details:
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.
For further information, see ISO 5725 and the Guide to Expression of Uncertainty in
Measurement.
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5.4.7 Control of Data
5.4.7.1 Calculations and Data Transfers
Policy:
Calculations and data transfers are subject to appropriate checks in a systematic manner.
Details:
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 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
Policy:
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 that:
computer software developed by the user is documented in sufficient detail and
suitably validated or otherwise checked as being adequate for use
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 (see section
4.13.1.4)
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
data is securely maintained by preventing unauthorized access to, and unauthorized
amendment of, computer records
Details and Procedures:
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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.
Commercially developed software in general use within its designed application range
may be considered sufficiently validated. Laboratory software configuration /
modifications are validated as outlined in SOP# QSP 5-5-1.
It is the stated goal of Chemtech-Ford Laboratories to meet the requirement for
Electronic records, electronic signatures, and handwritten signatures executed to
electronic records as defined by 21 CFR. Part 11 (Docket No. 92NO251) RIN0910-
AA29; Federal Register: March 20, 1997, Volume 62, Number 54), Rules and
Regulations, pages 13429-13466. Chemtech-Ford is not now fully compliant, but records
of compliance evaluation are maintained and can be inspected upon request.
For details of the requirement see:
http://www.fda.gov/ora/compliance_ref/part11/
Revision History
Changes from Revision 24
Revision 25 is a significant revision with numerous additions, deletions and corrections.
These are not all documented in the revision history, rather all persons on the distribution
list are required to read the entire document.
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5.5 Equipment
Section Synopsis
This section tells you to:
1. Identify information needs for accept / reject decisions
2. Install equipment capable of providing that information
3. Use the equipment in the proper environment
4. Periodically check the equipment calibration
Key Words
Required Equipment and Accuracy
Authorized Personnel
Unique Identification
Inventory
Maintenance
Procedures
Out of Service
Calibration Status
Re-verification
Checks
Correction Factors
Safeguards against Adjustment
Cross-references
ISO 17025:2005 Section 5.5
ISO 9001:2000 Section 4.2.1, 4.2.3, 5.1, 6.2.2, 6.3.1, 7.1, 7.4, 7.5.1, 7.5.2, 7.5.3,
7.6, 8.1, 8.2.3, 8.2.4
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5.5.1 Required Equipment
Policy:
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.
Details:
Equipment is used in an environment appropriate to its proper 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.
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5.5.2 Required Accuracy
Policy:
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.
Details:
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
Policy:
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.
Details:
Access to laboratory equipment is controlled to ensure that only authorized personnel use
equipment.
5.5.4 Unique Identification
Policy:
Each item of equipment used for testing and calibration is uniquely identified when
practicable.
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Details:
Measuring and testing equipment is uniquely identified. 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
Policy:
Records are maintained for each item of equipment significant to the tests and/or
calibrations performed. The records include the following:
identity of the item of equipment (and its software)
manufacturer’s name, type identification, and serial number and/or other unique
identification
Date received (if available)
Date placed into service (if available)
checks that equipment complies with the specification (see section 5.5.2)
current location, where appropriate
the manufacturer’s instructions, if available, or reference to their location
dates, results and copies of reports and certificates of all calibrations, adjustments,
acceptance criteria, and due date of next calibration
maintenance carried out to date and the maintenance plan (includes calibration)
damage, malfunction, modification or repair to the equipment
Analysts initials
Details:
A database is used to capture the above inventory information. The above information
related to service and maintenance is kept in Quality Manager. Other information
recorded may include:
date received and date placed in service
condition when received (e.g., new, used, refurbished)
dates and results of calibration and/or verification and date of next calibration and/or
verification
performance history, where appropriate (e.g., response time, drift, noise level)
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5.5.6 Equipment Procedures
Policy:
The SOP# QSP 5-5-1 is utilized as an established plan for safe handling, transport,
storage, use and maintenance (including calibration) of measuring equipment, and
appropriate use of correction factors to ensure proper functioning and in order to prevent
contamination or deterioration.
Note – additional procedures may be necessary when measuring equipment is used
outside the permanent laboratory for tests, calibrations, or sampling (currently not
applicable at our laboratory).
Details and Procedures:
The procedures for each piece of measuring equipment are located in the appropriate
room where the equipment is located. These procedures detail any information for safe
handling, transport, storage, use, and maintenance of measuring equipment.
5.5.7 Out of Service Equipment
Policy:
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.
Details:
Routine testing work is completely discontinued on equipment that even shows minor
nonconformances. Not only do we do this for ethical reasons in support of our customer,
but minor nonconformances are often indicative of major breakdowns in expensive
equipment. These breakdowns need to be avoided wherever possible.
Out of service equipment is clearly marked as outlined in section 5.5.8.
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.
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5.5.8 Calibration Status
Policy:
Equipment requiring calibration is labeled to indicate the calibration status and/or
operational status and the date when re-calibration is due when appropriate.
Details:
Calibration labels have a write-on surface and a pressure sensitive adhesive. The areas
that are filled out include the person who performed the calibration, the date it was
performed, the date it is due for re-calibration, and the equipment’s identification
number.
Measuring equipment that has failed calibration or is deemed out of service is labeled
with one of the following labels:
A piece of equipment that is not calibrated or checked is labeled with the following label:
5.5.9 Return to Service
Policy:
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.
Details and Procedures:
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
CALIBRATION VOID
DO NOT USE
CALIBRATION
BY DATE
DUE ID#
OUT OF SERVICE
DO NOT USE
FOR REFERENCE ONLY
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manufacturer’s equipment manual. Any additional quality control checks are outlined in
the “Quality Control Plan” section of the appropriate test method.
5.5.10 Periodic Checks
Policy:
When intermediate checks are needed to maintain confidence in the calibration status of
equipment, these checks are carried out periodically according to defined procedure.
Details and Procedures:
As stated in section 5.5.6, the procedures for each piece of measuring equipment are
available on the laboratory computer network. SOP# QSP 5-5-1 outlines a general
maintenance plan for equipment and includes various checks. 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
Policy
Calibrations that give rise to a set of correction factors are updated along with all copies
of this data (e.g., in computer software).
Details and Procedures:
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
Policy:
Test and calibration equipment, including hardware and software, are safeguarded from
adjustments that invalidate test and/or calibration results/status.
Details:
Safeguards against adjustment for laboratory equipment include:
detailed SOPs and manufacturer’s manuals on the operation of the equipment
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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
Revision History
Changes from Revision 24
Revision 25 is a significant revision with numerous additions, deletions and corrections.
These are not all documented in the revision history, rather all persons on the distribution
list are required to read the entire document.
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5.6 Measurement Traceability
Section Synopsis
This section tells you:
1. Measurements are traceable to SI units (when applicable)
2.Reference Standards and Reference Materials are used
Key Words
Systemèm International
Reference Standard
Reference Material
Traceability
Cross-references
ISO 17025:2005 Section 5.6
ISO 9001:2000 Section 6.3.1, 7.1, 7.5.1, 7.6
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5.6.1 General
Policy:
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. As mentioned in section 5.5, the SOP#QSP 5-5-1
outlines an established program for the maintenance of equipment and includes calibration.
Details:
The program includes a system for selecting, using, calibrating, checking, controlling, and
maintaining:
measurement standards
reference standards used as measurement standards
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
measurement of weights, volumes, time intervals, temperatures, and pressures and
related calculations
relevant processes (e.g., pH adjustment, sterilization)
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/or expiry. The person responsible for the
preparation of the reagent is identified either from the label or from records.]
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5.6.2 Specific Requirements
5.6.2.1 Calibration
Policy:
The program for calibration equipment is designed and operated to ensure that calibration
measurements are traceable to the System International (SI) units of measurement.
Details:
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 (see also section
5.10.4.2).
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.
Maintain certificates of all reference standards, measuring equipment, or certified reference
material used in ensuring traceability. Where traceability to national standards of
measurement is not applicable, the laboratory provides satisfactory evidence of correlation
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of results, for example by participation in a suitable program of inter-laboratory
comparisons or proficiency testing.
Reference standards, such as thermometers and weights, are traceable to a national or
international standard (e.g., NIST).
5.6.2.1.1 Instrument Performance Evaluation
5.6.2.1.1.1 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.
5.6.2.1.1.2 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.
5.6.2.1.2 Calibration
5.6.2.1.2.1 Generally, as applicable to the method, calibration curves are established for
each parameter using known concentrations of standards. At least three
different concentrations in non-interfering matrices, that span the range of
expected sample values are analyzed and plotted. Generally, a correlation
coefficient of better than 0.995 constitutes an acceptable calibration.
5.6.2.1.2.2 Method-specific calibration requirements are included in individual SOPs. In
this case, the analytical method will take precedence.
5.6.2.1.3 Continuing Calibration
5.6.2.1.3.1 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
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calibration standards. When bracketing is required, only results between
valid calibration verification standards can be used.
5.6.2.1.3.2 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 either initially and during sample analysis or at a rate that the
established method requires. The continuing calibration (may be substituted
by the check standard) is 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-celebrated. Continuing
calibration standards must agree within established limits of calibration. If
not, the cause of the discrepancy is identified, corrected, and documented.
5.6.2.1.4 Initial Calibration Verification (ICV)
5.6.2.1.4.1 An ICV is a well-characterized material that is run, at a minimum, with each
calibration. The material, which is obtained from a documented second
source. 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.
A calibration check solution or sample material should be analyzed at least
each day of analysis to demonstrate that calibration and standardization of
instrumentation is within acceptable limits.
5.6.2.1.5 Calibration Policy
5.6.2.1.5.1 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, flow rate (e.g.,
rotometers), volume (e.g., dry gas meters), temperature measurement
equipment, balances, weights, thermometers, pH meters, SRM’s, etc.
5.6.2.1.5.1.1 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.
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5.6.2.1.5.3 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.
5.6.2.2 Testing
5.6.2.2.1 Uncertainty
Policy:
The requirements given in section 5.6.2.1 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.
Details:
The extent to which the requirements in section 5.6.2.1 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, as
given in section 5.6.2.2.2.
5.6.2.2.2 Traceability
Policy:
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
participation in a suitable program of inter-laboratory comparisons or proficiency testing
Details:
Reliable characterization involves an estimate of recovery.
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The laboratory participates in proficiency testing and/or check sample programs. The list of
programs is maintained by the Quality Manager.
5.6.3 Reference Standards and Reference Materials
5.6.3.1 Reference Standards
Policy:
The SOP# QSP 5-6-1 outlines the program for the calibration of reference standards.
Reference standards are obtained or calibrated by a body that can provide traceability as
described in section 5.6.2.1. 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.
Details:
Reference standards are obtained from ISO certified vendors], if applicable.
5.6.3.2 Reference Materials
Policy:
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.
Details:
Reference materials, 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.
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5.6.3.3 Intermediate Checks
Policy:
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.
Details and Procedures:
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. It is
the responsibility of the Quality Manager to establish and maintain the individual schedule
for each SOP and/or test method. 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.
5.6.3.4 Transport and Storage
Policy:
The SOP# QSP 5-6-1 outlines 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.
Revision History
Changes from Revision 24
Revision 25 is a significant revision with numerous additions, deletions and corrections.
These are not all documented in the revision history, rather all persons on the distribution
list are required to read the entire document.
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5.7 Sampling
Section Synopsis
This section tells you:
1. There must be a sampling plan and procedure
2. Appropriate records of sampling are kept
3. Deviations, additions, and exclusions from the plan or procedure are
recorded
Key Words
Sampling Plan and Procedure
Deviation, Addition, or Exclusion
Cross-references
ISO 17025:2005 Section 5.7
ISO 9001:2000 Section 4.2.4, 7.5.1
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5.7.1 Sampling Plan and Procedures
Chemtech-Ford, Inc. Does not currently perform sampling.
Revision History
Changes from Revision 24
Revision 25 is a significant revision with numerous additions, deletions and corrections.
These are not all documented in the revision history, rather all persons on the distribution
list are required to read the entire document.
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5.8 Handling of Test and Calibration Items
Section Synopsis
This section tells you to:
1. Keep samples in good condition.
Key Words
Identification
Receipt
Protection
Cross-references
ISO 17025:2005 Section 5.8
ISO 9001:2000 Section 6.3, 6.4, 7.1, 7.4.3, 7.5, 8.2.4
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5.8.1 Procedures
Policy:
The SOP#QSP 5-8-1 outlines the procedures for the transportation, receipt, handling,
protection, storage, retention and/or disposal of test and/or calibration items, including all
provisions necessary to protect the integrity of the test or calibration item, and the interests
of the laboratory and the customer.
Details:
Samples, reagents, and standards are stored so as to ensure their integrity by preventing
against deterioration, contamination, and loss of identity. It is recognized that this is a
general statement, but details are elaborated upon in SOP# QSP 5-8-1.
5.8.2 Identification of Test and/or Calibration Items
Policy:
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.
Details:
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
Policy:
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 customer for further instructions
before proceeding and keeps a record of the discussion.
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The Chemtech-Ford sample acceptance policy is detailed in document QSP 5-8-3.
Details:
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.
5.8.4 Protection
Policy:
The SOP#QSP 5-8-1 outlines the procedures and appropriate facilities for avoiding
deterioration, loss or damage to the test or calibration item during storage, handling and
preparation and testing; instructions provided with the item are followed. When items have
to be stored or conditioned under specified environmental conditions, these conditions are
maintained, monitored, and recorded. Where a test item is to be held secure (e.g., for reasons
of record, safety or value, or to enable complementary test and/or calibrations to be
performed later), the laboratory has arrangements for storage and security that protect the
condition and integrity of the secured item concerned.
Details:
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.
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Where a sample, 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.
Revision History
Changes from Revision 24
Revision 25 is a significant revision with numerous additions, deletions and corrections.
These are not all documented in the revision history, rather all persons on the distribution
list are required to read the entire document.
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5.9 Assuring the Quality of Test Results
Section Synopsis
This section tells you:
1. That results are monitored
2. There is a plan for monitoring
Key Words
Internal Quality Control
Statistical Techniques
Inter-laboratory Comparisons
Proficiency Testing
Certified Reference Materials
Secondary Reference Material
Replicates
Re-testing
Correlation
Cross-references
ISO 17025:2005 Section 5.9
ISO 9001:2000 Section 6.3, 6.4, 7.1, 7.2.1, 7.2.2, 7.3, 7.4.3, 7.5.1, 7.5.2, 7.5.3,
7.5.5, 8.1, 8.2.3, 8.2.4, 8.4
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5.9.1 Quality Control / Quality Assurance
Policy:
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 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
Details:
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.
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 Plan" of each
test method.
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.
The QM 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.
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Technical personnel use certified reference materials and 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.
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.
5.9.1.1 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.
5.9.1.1.1 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. One duplicate
sample is analyzed for each matrix type and method, and for each sample batch,
or for each sample batch containing 20 samples, whichever is less. The relative
percent difference (RPD) for each component is then calculated and compared to
the acceptance limits for the matrix and method.
5.9.1.1.2 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 Evaluation (PE) studies is also utilized to monitor accuracy of
data in the laboratory.
5.9.1.1.3 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.
5.9.1.2 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
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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.
5.9.1.2.1 Matrix Spike and Matrix Spike Duplicate - Matrix spikes are employed to
monitor recoveries and maintain extraction and/or concentration 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.
5.9.1.2.1.1 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
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.
Solutions used to fortify samples should, when possible, be made from a
source other than that from which the calibration standards are made.
Percent recovery of matrix spikes is determined using the following:
Percent Recovery = (SSR-SR)/SA x 100
Where:
SSR = Spiked Sample Result
SR = Sample Result
SA = Spike Added
5.9.1.2.1.2 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.
5.9.1.2.1.3 Laboratory matrix spikes and matrix spike duplicates must be prepared
and analyzed for each ten samples for drinking water and for each twenty
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samples for RCRA and wastewater analyses. This procedure provides
information regarding the precision of an analysis. (These sample types are
not always possible due to the type of analysis, for example pH.) The
relative difference between duplicate measurements is assessed using the
following equation:
Relative Percent Difference (RPD) = |D1-D2|/ ((D1 + D2)/2) x 100
Where:
D1 = Sample Value
D2 = Duplicate Sample Value
5.9.1.2.2 Laboratory Control Spikes - Compounds of interest are added to reagent blank
samples prior to extraction and analysis, as required by each method SOP.
Compound recoveries and reproducibility are then compared with tables of
acceptance for each method.
5.9.1.2.3 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 or duplicate spike analysis must
range between + 2 standard deviations (SD) of historical relative percent
difference (RPD), when 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.
5.9.1.2.4 Surrogates - Surrogate spike compounds of interest are added to each sample
prior to extraction and analysis. Compound recoveries and reproducibility are
then compared with tables of acceptance for each method.
5.9.1.2.5 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.
5.9.1.2.6 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
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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.
5.9.1.2.7 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 solution that is “second source” in difference from the calibration
standards/tuning standards. These solutions will be used to verify the stability
of the analytical curve established for the current analytical run.
5.9.1.2.7.1 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. Control limits during analysis of these solutions
will be subject to the QA protocol as defined by the method SOP.
5.9.1.2.7.2 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 or no greater than + 20 percent of the true value.
Where method specific ranges exist, they may be used.
5.9.1.2.8 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 QA SOP protocol. Selection of appropriate
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formulae to reduce raw data to final results is included in the method analyte
SOP
5.9.1.3 Other Quality Control Measures
5.9.1.3.1 Control charts can be produced by analyte for the evaluation of QA/QC data.
The charts are produced by the LIMS software.
5.9.1.4 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, contained in Chemtech-Ford, Inc.'s Data Validation and Acceptance
Procedure, have been established to be used in the evaluation of out-of-control
data for each analytical SOP
5.9.2 Correction and Prevention
Policy and Details:
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.
Revision History
Changes from Revision 24
Revision 25 is a significant revision with numerous additions, deletions and corrections.
These are not all documented in the revision history, rather all persons on the distribution
list are required to read the entire document.
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5.10 Reporting of Results
Section Synopsis
This section tells you:
1. What needs to be on a report
2. How to handle amendments to reports
Key Words
Specific Information
Required Information
Interpretation
Opinion
Subcontractor
Electronic Transmission of Results
Format
Amendments
Cross-references
ISO 17025:2005 Section 5.10
ISO 9001:2000 Section 6.1, 6.3.1, 7.1, 7.2.1, 7.2.2, 7.4.3, 7.5.1,
7.5.4, 7.5.5, 8.2.4
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5.10.1 General
Policy:
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. This information may include what is outlined
in section 5.10.2, 5.10.3 and 5.10.4.
Details:
Test reports are issued as either hard copy or by electronic data transfer.
5.10.2 Test reports and certificates
Policy:
Test reports include the following information, as appropriate:
a title (e.g., “Certificate of Analysis”)
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
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
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Details:
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
(Page 3 of 16).
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
Policy and Details:
In addition to the requirements listed in section 5.10.2, test reports include the following,
where necessary for the interpretation of results:
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 (see section 5.10.5)
additional information required by specific methods, customers, or groups of customers
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5.10.3.2
Policy and Details:
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:
date 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
5.10.4.1
Policy:
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.
Details:
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 (see 5.6.2.1.1)
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5.10.4.2
Policy:
This section is not applicable to a testing laboratory.
5.10.4.3
Policy:
This section is not applicable to a testing laboratory.
5.10.4.4
Policy:
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
Policy:
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.
Note - Opinions and interpretations should not be confused with inspections and product
certifications as intended in ISO/IEC 17020 and ISO/IEC Guide 65.
Details:
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
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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
Policy and Details:
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
Policy:
In the case of transmission of test results by telephone, facsimile or other electronic or
electromagnetic means, the requirements of the policies and procedures of this Quality
Manual continue to apply (see also 5.2.7.1.2).
Details:
Signatures are recorded on file at the laboratory. Clients may request a hardcopy example of
signatures.
5.10.8 Format of Reports
Policy:
The format of reports is designed to accommodate each type of test carried out and to
minimize the possibility of misunderstanding or misuse.
Details:
The layout of the test report is such that the presentation of the test data facilitates ease of
assimilation by the reader.
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5.10.9 Amendments to Reports
Policy:
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.
Details:
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.
Details for producing an amended report are located in document QSP-5-10-9.
Revision History
Changes from Revision 24
Revision 25 is a significant revision with numerous additions, deletions and corrections.
These are not all documented in the revision history, rather all persons on the distribution
list are required to read the entire document.
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:_______________________
Document No. EM-QA-IP-1129
Revision No. 16
Effective Date: 10/02/2020
Page 2 of 133
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:_______________________
Document No. EM-QA-IP-1129
Revision No.: 16
Effective Date: 10/02/2020
Page 3 of 133
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
Document No. EM-QA-IP-1129
Revision No.: 16
Effective Date: 10/02/2020
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
Company Confidential & Proprietary
Document No. EM-QA-IP-1129
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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Document No. EM-QA-IP-1129
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Effective Date: 10/02/2020
Page 6 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.
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
Company Confidential & Proprietary
Document No. EM-QA-IP-1129
Revision No.: 16
Effective Date: 10/02/2020
Page 7 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.
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
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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.
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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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
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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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