DSHW-2024-007650

Deq submit <[e-mail]>
Draft Prison SAP
1 message
Stephen Galley <[e-mail]>Mon, Aug 5, 2024 at 10:41 AM
To: "Shawn Anderson (UDC)" <[e-mail]>, Robert Kempe <[e-mail]>, "Shane Welch (UDC)"
<[e-mail]>, Aubrey Stapel <[e-mail]>, Jon Vance <[e-mail]>, Douglas Hansen
<[e-mail]>, Deborah Ng <[e-mail]>, Stevie Norcross <[e-mail]>, Kaci McNeill
<[e-mail]>, "Leonard Wright," <[e-mail]>, Dave Roskelley <[e-mail]>, Steve Smith
<[e-mail]>, Jamison Moss <[e-mail]>, "Brian Kenney (UDC)" <[e-mail]>,
[e-mail]
All:
The Draft SAP dated August 5, 2024 is attached for review by DEQ.
DRAFT - DFCM RCRA Closure SAP, Former
Draper Prison, Draper, UT, 08-05-24.pdfWe request that all DEQ Divisions send us their comments as a single roll-up from DEQ. This will prevent double tapping
items and also prevent conflicting requirements. We can then address the comments universally when they are received.
If there are issues downloading due to government security controls, please notify me by replying to this email and we will
make other arrangements to get you the document.
Thank you
Stephen

Stephen S. Galley, CSP
R&R Environmental, Inc.
47 West 9000 South, Suite #2
Sandy, Utah 84070
m: [phone]
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[e-mail]
8/5/24, 10:46 AM State of Utah Mail - Draft Prison SAP
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SUBSURFACE SAMPLING AND ANALYSIS PLAN
FORMER DRAPER PRISON
UTD980951727
14425 SOUTH BITTERBRUSH LANE
DRAPER, UTAH 84020

AUGUST 5, 2024
DRAFT

PREPARED FOR
1480 NORTH 8000 WEST
SALT LAKE CITY, UTAH 84116

PREPARED BY
47 West 9000 South, Suite 2
Sandy, Utah 84070
Phone: [phone]
[e-mail]
SUBSURFACE SAMPLING AND ANALYSIS PLAN
Former Draper Prison
Draper, Utah 84020

i

TABLE OF CONTENTS
1.0 INTRODUCTION ............................................................................................................................ 1
1.1 Facility History ........................................................................................................................ 1
1.2 RCRA Generator Closure ........................................................................................................ 2
1.3 Purpose and Scope ................................................................................................................... 2
1.4 Protocol .................................................................................................................................... 2
1.5 Approvals ................................................................................................................................. 2
1.6 References ................................................................................................................................ 3
2.0 METHODOLOGY AND CERTIFICATIONS .............................................................................. 4
2.1 Sampling and Inspection Rationale .......................................................................................... 4
2.1.1 Sampling for Priority Pollutant Metals .................................................................................... 4
2.1.2 Inspecting for Asbestos ............................................................................................................ 4
2.1.3 Inspection and Sampling Requirements ................................................................................... 4
2.2 Sample Summary ..................................................................................................................... 9
2.3 Data Compilation ................................................................................................................... 10
3.0 SAMPLING TEAM ........................................................................................................................ 11
3.1 Project Manager ..................................................................................................................... 11
3.2 Safety Officer ......................................................................................................................... 11
3.3 Soil Sampler ........................................................................................................................... 11
3.4 Asbestos Inspector ................................................................................................................. 11
3.5 Quality Assurance/Quality Control Officer ........................................................................... 12
4.0 SAMPLING PROCEDURES ........................................................................................................ 13
4.1 Survey .................................................................................................................................... 13
4.2 Drilling ................................................................................................................................... 14
4.3 Sample Aliquots ..................................................................................................................... 15
4.4 Surface Soil Samples for Priority Pollutant Metals in Soil .................................................... 15
4.5 Samples for Asbestos in Construction Debris ........................................................................ 15
4.6 Asbestos Sample Locations.................................................................................................... 16
4.7 Changes to PPol Metals Sample Locations Based on Suspect ACM Discovery ................... 17
6.0 SAMPLE HANDLING AND CUSTODY .................................................................................... 19
6.1 Chemistry Samples ................................................................................................................ 19
6.2 Asbestos Samples ................................................................................................................... 19
6.3 Field Notebooks ..................................................................................................................... 19
6.4 Organic and Inorganic Chemistry Sample Storage and Shipping .......................................... 20
6.5 Asbestos Sample Storage and Shipping ................................................................................. 20
7.0 APPENDICES................................................................................................................................. 21
Appendix A—MAPS OF WORK AREAS FOR SURVEYING AND SAMPLING
Appendix B—UDEQ CORRESPONDENCE
Appendix C—CHEMTECH-FORD QA MANUAL
Appendix D—EUROFINS RESERVOIRS ENVIRONMENTAL, INC. QA MANUAL
Appendix E—RECORD OF CHANGES (Not Presently Used)

SUBSURFACE SAMPLING AND ANALYSIS PLAN
Former Draper Prison
Draper, Utah 84020

1
1.0 INTRODUCTION

1.1 Facility History

Authorization for the construction of a new prison was given by the State of Utah Legislature in 1937. It
was to be built on a "pay-as-you-go" basis. A Draper farm site of 1,009 acres, located twenty-two miles
south of Salt Lake City was chosen. After a work stoppage caused by World War II shortages, prisoners
were moved to the new prison facility in 1951.

The Utah State Prison (USP) was one of two prisons managed by the Utah Department of Corrections
(UDC), Division of Institutional Operations. The location was in Draper, Utah, United States, about 20
miles southwest of Salt Lake City. It was replaced by the Utah State Correctional Facility in July 2022
and the new facility is located approximately 20 miles north of the previous location.

The prison was built to replace Sugar House Prison, which closed in 1951. The location was once
considered remote, and the nearby communities were rural. Since the prison's construction, business parks
and residential neighborhoods have developed the once rural area into a suburban one. Seeking the ability
to offer a better treatment option, the state legislature initiated a process to build a new prison, deciding it
was best to relocate elsewhere. Several sites were under consideration. A study was completed in 2005 by
Wikstrom Economic & Planning Consultants, Inc., to determine if moving the prison would be feasible.
The test of feasibility was whether the value of the real estate of the current location could support the
cost of relocation. It was determined that the cost of relocating the prison far exceeded the value that
could be realized from the sale of the Draper prison site. However, on August 19, 2015, a special session
of the state legislature voted to move the prison to the west side of Salt Lake City. The former Draper
prison is now closed.

The large prison complex housed both male and female prisoners in separate units. The prison had a
capacity of over 4,000 inmates. The Draper site was located near Point of the Mountain along
the Traverse Ridge and consisted of several units named after surrounding mountains and mountain
ranges. These units range from minimum security to supermax. The Uintas housed maximum security
units for male inmates and included a supermax facility and execution chamber. Wasatch and Oquirrh
units housed the medium security male inmates. Promontory unit was a medium security therapeutic
community designed to treat drug abusers. Timpanogos unit housed female inmates and Olympus was the
mental health unit. Lone Peak was a minimum-security unit.

During the later part of the former prison history, the facility conducted various operations with the
prisoners such as cabinetry, painting operations, Dairy operations, vehicle maintenance, and asbestos
abatement activities. Some of these operations fell under the Resource Conservation and Recovery Act
(RCRA).

On July 16, 1984, UDC notified as an LQG of hazardous waste on EPA Form 8700-12 and notified of
management of D001, F002, and F003 wastes. On February 19, 2004, UDC re-notified as a Small
Quantity Generator (SQG) managing D001, F002, and F003 wastes. During a 2008 inspection, the
Director’s representatives (inspectors) and Environmental Protection Agency (EPA) representatives
identified spills and mismanagement of containers (DSHW-2008-007561). During a 2016 inspection,
inspectors identified mismanagement of containers (DSHW-2016-010264). Also, the notification to the
local hospital sent by UDC’s Safety/Compliance representative identified additional wastes, including:
“Paint waste with Benzene, Acetone, Toluene, Xylene Press Wash waste with Petroleum Distillates,
Xylenes, Aliphatic Solvent Naphtha”

SUBSURFACE SAMPLING AND ANALYSIS PLAN
Former Draper Prison
Draper, Utah 84020

2
On April 8, 2024, per the Director’s request, UDC (1) re-notified as an SQG managing D001, F003, and
F005 wastes and (2) notified of closure of Facility 1, which was two years after the required LQG closure
notification requirements in Utah Admin. Code R315-262-17(a)(8). UDC also indicated that it was not in
compliance with the performance standards in 40 C.F.R. 262.17(a)(8) and Utah Admin. Code R315-262-
17(a)(8)(iii). Between February 2024 and May 2024, the Director received documentation from UDC,
including sampling and soil boring analyses from the removal of Underground Storage Tanks, hazardous
waste manifests of containers shipped off site, and a map of the operation areas. UDC did not properly
notify the Director, and inspectors were therefore unable to inspect Facility 1 prior to demolition. UDC
had not met the LQG closure requirements for Facility 1 specified in Utah Admin. Code R315-262-
17(a)(8) as of the 2024 dates.

1.2 RCRA Generator Closure

On June 19, 2024, the State of Utah, Department of Environmental Quality (DEQ), Division of Solid and
Hazardous Waste (DSHW) letter, DSHW-2024-003012, was issued to the Utah Correctional Industries
(UCI) Director. It is noted that UCI is a State of Utah entity under UDC. UCI had R&R Environmental,
Inc. issue a response letter dated July 8, 2024, to DEQ, DSHW indicating responses to DEQ
interrogatives for two separate EPA ID numbers. The letter included a recommendation for an immediate
administrative closure of the UTR000017855 EPA ID number. The letter further indicated that the UCI
would prepare this Sampling and Analysis Plan (SAP) for the collection of data to be used for the closure
of the facility as EPA ID number UTD980951727.

1.3 Purpose and Scope

This document represents the Sampling and Analysis Plan (SAP) for the sampling of the Former Draper
Facility as a whole. The facility site is currently mostly brought to grade with the demolition of buildings
and structures. This plan’s purpose is to collect data concerning the facility processes, using existing
knowledge and conducting investigatory work to identify previous locations on the facility where
chemicals were used and potentially stored. This SAP serves as the basis for collecting data for
compilation into a final report that may be used to determine if additional sampling or cleanup operations
need to occur on the site. This scope does not include determinations of soils composition for the possible
identification of asbestos. The provisions of this plan apply to the investigations and sampling to be
conducted at the Former Draper Facility within the plan’s scope.

1.4 Protocol

Contained herein are the sampling and analysis protocols for Priority Pollutant metals and chemicals in
soil in the areas to be sampled. This approach will ensure the process is compliant with applicable federal,
state, and local regulations. Regulatory comments, replies to those comments, and changes, are included
in Appendix E.

The sampling practices outlined are specifically designed to provide hazardous waste information and
occupational hazard assessment information that support activities to facilitate the determination of the
facility’s subsurface soils. However, the information obtained may also be used to provide support for
proper disposal of any soils that are determined to be hazardous.

1.5 Approvals

This Sampling and Analysis Plan (SAP) is approved by R&R Environmental, Inc., as certified by
signatures below.
SUBSURFACE SAMPLING AND ANALYSIS PLAN
Former Draper Prison
Draper, Utah 84020

3

Stephen S. Galley, MAEd., CSP David C. Roskelley, MSPH, CIH, CSP
Environmental Services Director, Vice President President
R&R Environmental, Inc. R&R Environmental, Inc.

1.6 References

1-77000-RM-001 Records Management Guidance for Records Sources.

Environmental Quality, Waste Management and Radiation Control, Waste Management. Hazardous Wate
Generator Requirements. R315-262-17(a)(8).

R&R Operating Procedure for Control of Records, R&R PROC-002, Most Recent Version.

R&R Operating Procedure for Logbooks, R&R PROC-010, Most Recent Version.

US EPA. Safety, Health, and Environmental Management Program Procedures and Policy Manual.
Region 4 SESD, Athens, GA, Most Recent Version.

SUBSURFACE SAMPLING AND ANALYSIS PLAN
Former Draper Prison
Draper, Utah 84020

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2.0 METHODOLOGY AND CERTIFICATIONS

The initial step in sampling for Total Petroleum Hydrocarbons (TPH) Gas (G) and Diesel (D), Benzene,
Toluene, Ethylbenzene, Xylenes, Naphthalene (BTEXN), Volatile Organic Compounds (VOC), Semi-
Volatile Organic Compounds (SVOC), Polychlorinated Biphenyls (PCB), Organochlorine Pesticides
(Organo. Pesticides), and Priority Pollutant Metals (PPol Metals), in environmental media is to research
the process knowledge, or building records, in addition to documents concerning the uses of these
chemicals. Also considered in this process are dates of removal and storage as well as locations from
which the waste was derived. This initial research with the tenant of the facility, also allows for the
consideration of sampling events specific to the soils that may have taken place in the past. For example,
some locations throughout the former prison site have had cursory and intensive sampling conducted for
chemicals or materials of concern. This data is included in the identification process for samples if it is
determined to be relevant and meets the minimum requirements of this plan and any related regulatory
drivers. The second step in this process is to physically inspect the areas to be sampled to identify
appropriate analytes and numbers of samples to be obtained.

2.1 Sampling and Inspection Rationale

Analytes for each sample were selected based on facility process information received from UCI. UCI
indicated the locations of buildings in the prison where specific processes were occurring. The
information was received and reviewed, and the specific analytes were selected for these locations based
on the chemicals that were likely used at each satellite location. The selected chemicals of concern to be
sampled for are intended to give the broadest view to identify potential issues that may exist below the
site.

2.1.1 Sampling for Priority Pollutant Metals

When inspecting for Priority Pollutant (PPol metals), suspect materials include (but are not limited to)
paint, lubricating fluids, insulation, rubber, soil, and building siding. The PPol metals are intended to
determine if residual welding metals are in the surface soils and at the location of unknown contaminants.
R&R Environmental, Inc., will supply a sampling technician who has been directly involved in a soil
sampling event in the Prison Facility. This requirement will allow for proper care and handling when
obtaining the samples.

2.1.2 Inspecting for Asbestos

R&R Environmental, Inc., will provide a federally accredited and State-of-Utah certified Asbestos
Building Inspector to obtain asbestos samples in the event a borehole core has suspect asbestos containing
materials in it. This sampling scheme is not intended to inspect for asbestos. However, since the site
dump locations have large quantities of asbestos that are presently being removed, having an accredited
asbestos inspector on the site is a reasonable precaution to ensure health and safety protocols on the site.
Non-suspect asbestos-containing materials are those made of wood, glass, plastic, metal, or rubber.
However, the Asbestos Inspector will consider materials on a case-by-case basis if they are discovered.
Suspect materials, if identified, will be separated into three general categories: surfacing materials,
thermal system insulation (TSI), and miscellaneous materials.

2.1.3 Inspection and Sampling Requirements

Approximate borehole locations are indicated in the attached figures (See Figures 1-5 in Appendix A).
The specific location information will be documented in the field in the logbooks of the Project Manager
SUBSURFACE SAMPLING AND ANALYSIS PLAN
Former Draper Prison
Draper, Utah 84020

5
and surveyed. The sample numbers and borehole designators are included in the table below. A copy of
the field logbook or the table below will be supplied as the final report from this plan.

Sample Summary Tables

Boring
Number
Type of
Sample Sample Location*** Matrix Analytes Sample
Number
B-1 Grab UCI Furniture Shop
Vadose Zone Soil VOC
SVOC S-1
B-1 Grab UCI Furniture Shop
Groundwater Level Water VOC
SVOC W-1
B-2 Grab UCI Furniture Shop
Vadose Zone Soil VOC
SVOC S-2
B-2 Grab UCI Furniture Shop
Groundwater Level Water VOC
SVOC W-2
B-3 Grab UCI Furniture Shop
Vadose Zone Soil VOC
SVOC S-3
B-3 Grab UCI Furniture Shop
Groundwater Level Water VOC
SVOC W-3
B-4* Grab UCI Furniture Shop
Vadose Zone Soil VOC
SVOC S-4
B-4* Grab UCI Furniture Shop
Groundwater Level Water VOC
SVOC W-4
B-5 Grab Timp Vocational Tng
Vadose Zone Soil TPH-G/D
BTEXN S-5
B-5 Grab Timp Vocational Tng
Groundwater Level Water TPH-G/D
BTEXN W-5
B-6 Grab Timp Vocational Tng
Vadose Zone Soil TPH-G/D
BTEXN S-6
B-6 Grab Timp Vocational Tng
Groundwater Level Water TPH-G/D
BTEXN W-6
B-7 Grab Timp Vocational Tng
Vadose Zone Soil TPH-G/D
BTEXN S-7
B-7 Grab Timp Vocational Tng
Vadose Zone Soil TPH-G/D
BTEXN
S-7
Duplicate
B-7 Grab Timp Vocational Tng
Vadose Zone Soil TPH-G/D
BTEXN
S-7
MS/MSD
B-7 Grab Timp Vocational Tng
Groundwater Level Water TPH-G/D
BTEXN W-7
B-7 Grab Timp Vocational Tng
Groundwater Level Water TPH-G/D
BTEXN
W-7
Duplicate
B-7 Grab Timp Vocational Tng
Groundwater Level Water TPH-G/D
BTEXN
W-7
MS/MSD
SUBSURFACE SAMPLING AND ANALYSIS PLAN
Former Draper Prison
Draper, Utah 84020

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B-8 Grab Flammable Storage
Vadose Zone Soil
TPH-G/D
VOC
SVOC
S-8
B-8 Grab Flammable Storage
Groundwater Level Water
TPH-G/D
VOC
SVOC
W-8
B-9 Grab Flammable Storage
Vadose Zone Soil
TPH-G/D
VOC
SVOC
S-9
B-9 Grab Flammable Storage
Groundwater Level Water
TPH-G/D
VOC
SVOC
W-9
B-10 Grab Flammable Storage
Vadose Zone Soil
TPH-G/D
VOC
SVOC
S-10
B-10 Grab Flammable Storage
Groundwater Level Water
TPH-G/D
VOC
SVOC
W-10
B-11 Grab Quonset Hut Storage
Vadose Zone Soil
TPH-G/D
BTEXN
Organo. Pesticides
S-11
B-11 Grab Quonset Hut Storage
Groundwater Level Water
TPH-G/D
BTEXN
Organo. Pesticides
W-11
B-12 Grab Quonset Hut Storage
Vadose Zone Soil
TPH-G/D
BTEXN
Organo. Pesticides
S-12
B-12 Grab Quonset Hut Storage
Groundwater Level Water
TPH-G/D
BTEXN
Organo. Pesticides
W-12
B-13 Grab Quonset Hut Storage
Vadose Zone Soil
TPH-G/D
BTEXN
Organo. Pesticides
S-13
B-13 Grab Quonset Hut Storage
Groundwater Level Water
TPH-G/D
BTEXN
Organo. Pesticides
W-13
B-14 Grab Motor Pool
Vadose Zone Soil
TPH-G/D
VOC
PCBs
S-14
B-14 Grab Motor Pool
Groundwater Level Water
TPH-G/D
VOC
PCBs
W-14
B-15 Grab Motor Pool
Vadose Zone Soil
TPH-G/D
VOC
PCBs
S-15
B-15 Grab Motor Pool
Groundwater Level Water
TPH-G/D
VOC
PCBs
W-15
SUBSURFACE SAMPLING AND ANALYSIS PLAN
Former Draper Prison
Draper, Utah 84020

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B-16 Grab Motor Pool
Vadose Zone Soil
TPH-G/D
VOC
PCBs
S-16
B-16 Grab Motor Pool
Groundwater Level Water
TPH-G/D
VOC
PCBs
W-16
B-17 Grab Motor Pool
Vadose Zone Soil
TPH-G/D
VOC
PCBs
S-17
B-17 Grab Motor Pool
Groundwater Level Water
TPH-G/D
VOC
PCBs
W-17
B-18 Grab Motor Pool
Vadose Zone Soil
TPH-G/D
VOC
PCBs
S-18
B-18 Grab Motor Pool
Groundwater Level Water
TPH-G/D
VOC
PCBs
W-18
B-19 Grab Motor Pool
Vadose Zone Soil
TPH-G/D
VOC
PCBs
S-19
B-19 Grab Motor Pool
Groundwater Level Water
TPH-G/D
VOC
PCBs
W-19
B-20 Grab Motor Pool
Vadose Zone Soil
TPH-G/D
VOC
PCBs
S-20
B-20 Grab Motor Pool
Groundwater Level Water
TPH-G/D
VOC
PCBs
W-20
B-21 Grab Motor Pool
Vadose Zone Soil
TPH-G/D
VOC
PCBs
S-21
B-21 Grab Motor Pool
Groundwater Level Water
TPH-G/D
VOC
PCBs
W-21
B-22* Grab Motor Pool
Vadose Zone Soil
TPH-G/D
VOC
Organo. Pesticides
PCBs
S-22
B-22* Grab Motor Pool
Groundwater Level Water
TPH-G/D
VOC
Organo. Pesticides
PCBs
W-22
NA Grab
UCI Welding/Sign
Shop
Surface (0-6 inches)
Soil PPol. Metals M-1
NA Grab
UCI Welding/Sign
Shop
Surface (0-6 inches)
Soil PPol. Metals M-2
SUBSURFACE SAMPLING AND ANALYSIS PLAN
Former Draper Prison
Draper, Utah 84020

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NA Grab
UCI Welding/Sign
Shop
Surface (0-6 inches)
Soil PPol. Metals M-3
B-23 Grab
UCI Welding/Sign
Shop
Vadose Zone
Soil VOC
SVOC S-23
B-23 Grab
UCI Welding/Sign
Shop
Groundwater Level
Water VOC
SVOC W-23
B-24 Grab
UCI Welding/Sign
Shop
Vadose Zone
Soil VOC
SVOC S-24
B-24 Grab
UCI Welding/Sign
Shop
Groundwater Level
Water VOC
SVOC W-24
B-25 Grab
UCI Welding/Sign
Shop
Vadose Zone
Soil VOC
SVOC S-25
B-25 Grab
UCI Welding/Sign
Shop
Groundwater Level
Water VOC
SVOC W-25
B-26 Grab Vocational Training
Vadose Zone Soil VOC
SVOC S-26
B-26 Grab Vocational Training
Groundwater Level Water VOC
SVOC W-26
B-27 Grab Vocational Training
Vadose Zone Soil VOC
SVOC S-27
B-27 Grab Vocational Training
Groundwater Level Water VOC
SVOC W-27
B-28 Grab Vocational Training
Vadose Zone Soil VOC
SVOC S-28
B-28 Grab Vocational Training
Groundwater Level Water VOC
SVOC W-28
B-29 Grab Dairy Dump North
Vadose Zone Soil
TPH-G/D
VOC
SVOC
PPol. Metals
PCB
S-29
B-29 Grab Dairy Dump North
Groundwater Level Water
TPH-G/D
VOC
SVOC
PPol. Metals
PCB
W-29
B-30 Grab Dairy Dump North
Vadose Zone Soil
TPH-G/D
VOC
SVOC
PPol. Metals
PCB
S-30
SUBSURFACE SAMPLING AND ANALYSIS PLAN
Former Draper Prison
Draper, Utah 84020

9
B-30 Grab Dairy Dump North
Groundwater Level Water
TPH-G/D
VOC
SVOC
PPol. Metals
PCB
W-30
B-31 Grab Dairy Dump West
Vadose Zone Soil
TPH-G/D
VOC
SVOC
PPol. Metals
PCB
S-31
B-31 Grab Dairy Dump West
Groundwater Level Water
TPH-G/D
VOC
SVOC
PPol. Metals
PCB
W-31
B-32 Grab Dairy Dump West
Vadose Zone Soil
TPH-G/D
VOC
SVOC
PPol. Metals
PCB
S-32
B-32 Grab Dairy Dump West
Groundwater Level Water
TPH-G/D
VOC
SVOC
PPol. Metals
PCB
W-32
B-33 Grab Dairy Dump West
Vadose Zone Soil
TPH-G/D
VOC
SVOC
PPol. Metals
PCB
S-33
B-33 Grab Dairy Dump West
Groundwater Level Water
TPH-G/D
VOC
SVOC
PPol. Metals
PCB
W-33
Reserved* Reserved Reserved As Identified Reserved TBD
*These designated borehole locations may be adjusted by the Environmental Engineer/Scientist in the field
and adjustments in placement will be at the discretion of the Engineer/Scientist.
**Priority Pollutant Metals (PPol.) include antimony, arsenic, barium, beryllium, cadmium, chromium,
copper, lead, mercury, nickel, selenium, silver, thallium, and zinc.
***Attempts will be made to achieve the desired level and location of sampling. However, geologic factors
and topography may not allow for all indications to be achieved.
NA=Not Applicable

2.2 Sample Summary

Surface and subsurface sample locations were selected based on the operations and processes that were
identified as occurring within certain buildings or areas. Samples will be obtained from the approximate
SUBSURFACE SAMPLING AND ANALYSIS PLAN
Former Draper Prison
Draper, Utah 84020

10
locations that are marked on the map Figures 1-5 which are in Appendix A. Samples and boreholes may
be added by the assigned Environmental Engineer/Scientist, if in the professional’s professional opinion,
or PID reading suggests, the additional sampling is prudent to allow for discovery of surface or
subsurface contamination at the facility. Asbestos samples, if required, will be obtained as necessary from
any materials identified during the sampling event. All asbestos samples will be collected by a federally
accredited and State of Utah certified Asbestos Building Inspector.

The R&R Project Manager reserves the right to add samples and analytical methods during the sampling
process if it is deemed warranted by the discretion of the Project Manager.

2.3 Data Compilation

The Project Manager will compile the information gathered during the sampling event. The Asbestos
Inspector will identify homogeneous areas of waste within the materials identified and will supply the
information to the Project Manager for compilation into the final report. This information is necessary for
regulatory compliance and the statistical reliability of the outcome.

An asbestos report and a soils and construction debris report will be completed following the receipt of
laboratory results, if any. Both reports will be forwarded to the State of Utah, Department of
Environmental Quality, Division of Waste Management and Radiation Control and the asbestos report, if
any, will also be forwarded to the Division of Air Quality.
SUBSURFACE SAMPLING AND ANALYSIS PLAN
Former Draper Prison
Draper, Utah 84020

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3.0 SAMPLING TEAM

The positions on the Sampling Team must have the below listed education, experience, and certifications.
Multiple positions may be held by the same person. However, the QA/QC Officer must not have any
other responsibilities.

3.1 Project Manager

The Project Manager shall have a minimum education of a bachelor’s degree in environmental science,
environmental engineering, or geology as well as a minimum of 30 years of direct experience in the field.
The Project Manager shall be current with Occupational Safety and Health Administration (OSHA) 40-
hour Hazardous Waste Emergency Operations and Emergency Response (HAZWOPER) training and will
hold a current certification in the State of Utah as an Asbestos Building Inspector. The Project Manager
has the ultimate responsibility for the overall project. This responsibility includes decision-making,
technical direction, logistics, safety, site control, and reporting. The Project Manager shall also have
successfully completed the OSHA 30-hour certification for general industry occupational safety and
health.

3.2 Safety Officer

The Safety Officer shall have a minimum education of a bachelor’s degree in any related field as well as a
minimum of 10 years of experience in safety. The Safety Officer will also report directly to the Project
Certified Industrial Hygienist (CIH). The Safety Officer is also responsible for detailing all information to
the Project Manager as well as the CIH. The Safety Officer shall hold a current Certified Safety
Professional (CSP) certification. The CIH shall hold a current CIH certification. The CIH will not be
required to be on site during field operations. However, if the Safety Officer requests, the CIH shall report
to the site within 4-hours. The Safety Officer is responsible for all safety on-site and has the authority to
shut the project down if necessary. (Note: All members of the Sampling Team are responsible for on-site
safety.)

3.3 Soil Sampler

The Soil Sampler shall have a minimum education of a high school diploma as well as a minimum of five
years of experience in soil sampling for environmental contaminants. The Soil Sampler shall report to the
Project Manager. The Soil Sampler is responsible for obtaining samples, as directed in this plan. The Soil
Sampler is also responsible for all soil sample containers, ice chests, chain-of-custody documents, and
final sample delivery to the environmental laboratory.

3.4 Asbestos Inspector

The Asbestos Inspector shall have a minimum education of a high school diploma as well as a minimum
of 5 years of experience in soil sampling for environmental contaminants. The Asbestos Inspector shall
report to the Project Manager. The Asbestos Inspector shall maintain a federal accreditation as an
Asbestos Building Inspector accreditation and a State of Utah Asbestos Inspector certification. The
Asbestos Inspector is responsible for visually identifying and sampling suspect asbestos-containing
material (ACM) identified on the site that is encountered by the Sampling Team. The Asbestos Inspector
will also determine the number of asbestos samples and locations of the asbestos samples. The Asbestos
Inspector is also responsible for asbestos containers, chain-of-custody documents, and final sample
delivery to the asbestos laboratory.

SUBSURFACE SAMPLING AND ANALYSIS PLAN
Former Draper Prison
Draper, Utah 84020

12
3.5 Quality Assurance/Quality Control Officer

The Quality Assurance/Quality Control (QA/QC) Officer shall have a minimum education of a high
school diploma as well as a minimum experience of 10 years in soil sampling for environmental
contaminants and 10 years of experience as an asbestos inspector. The QA/QC Officer shall report to the
Project Manager. The QA/QC Officer is responsible for the overall and final integrity and quality of the
samples and proper completion of documents.

SUBSURFACE SAMPLING AND ANALYSIS PLAN
Former Draper Prison
Draper, Utah 84020

13
4.0 SAMPLING PROCEDURES

Appropriate safety precautions will be observed and followed to prevent the spread of contaminants and
to protect site personnel and other personnel in the areas where sampling is occurring. Non-asbestos
samples will be obtained as grab samples. Asbestos (if encountered) will be sampled as suspect asbestos-
containing material as identified by the State of Utah certified and federally accredited asbestos building
inspector.

4.1 Survey

Survey will be performed by a Utah licensed survey company. In advance of the sampling, the survey
subcontractor will obtain the building corners of the buildings where sampling will occur. The survey
reconstruction is designed to identify building locations for borehole and sample placement. The building
corners requiring survey are listed below and are detailed in Figures 6-9:

Building Figure Building Wall
Being Simulated
Building Corner
Requiring Survey
Blue Flag Identifying
Marks*
UCI Furniture Shop 6 NW, SW Noted on Figure Name of Building, F6
Timpanogas Automotive VT 7 W Noted on Figure Name of Building, F7
UCI Farm Storage Quonset 8 W Noted on Figure Name of Building, F8
UCI Flammable Storage Building 8 W Noted on Figure Name of Building, F8
Motorpool/Garage/Grounds 8 NW, NE, SE, SW Noted on Figure Name of Building, F8
UCI Welding Shop, Plate Plant, and Sign Shop 9 NW, NE, SW Noted on Figure Name of Building, F9
Vocational Training Building 9 NW, SW Noted on Figure Name of Building, F9
Note 1: F = Figure. The number following the F is the specific Figure number.
Note 2: The survey point # shall follow the figure designator as indicated on the respective Figure.
*Identifying location flag will note the building name as well as the abbreviated Figure and survey corner unique identifier.
Prior to the field sampling event, the survey subcontractor will obtain building corner location
information from historical, aerial, drone imagery. The survey subcontractor, on the business day prior to
sampling, will survey in and recreate the building corners as indicated in Appendix A, on Figures 6-9.
The surveyed building corners will be labeled as indicated above and from the figures, and the labeling
will be written on a blue pin flag for ease of identification. Building corners not completely surveyed and
flagged prior to the first day of sampling will be completed on the first day of the actual sampling event.
Survey equipment to be used will be Trimble R-12 GPS, or similar. Building corners can be accurately
represented using historical location extractions, to effectively represent the building corners within an
accuracy of approximately 1.0’. On the first day of the sampling event, the surveyor will be at the site to
walk sampling personnel through sample recreation locations and ensure they can be identified by
sampling personnel.

The borehole locations will be laid out by the Environmental Engineer/Scientist or by the Environmental
Professional based on the building corner locations identified and marked by the surveyor. The
Environmental Engineer/Scientist will mark each borehole location, following sampling and backfill of
each borehole, with a red pin flag. The red pin flags will be placed within approximately one foot of each
borehole and the pin flag will be identified with the borehole number (e.g. “B-1”, “B-17”, “B-xx”…).

Upon completion of the drilling portion of the field work, but not more than three days following, the
surveyor will return to the site and survey each borehole location to an accuracy of 0.1’. The surveyor will
also sample the ground surface level at each borehole location to within ± .02’. The ground surface level
SUBSURFACE SAMPLING AND ANALYSIS PLAN
Former Draper Prison
Draper, Utah 84020

14
survey measurement will be used to calculate groundwater depth, if groundwater is identified during
sampling.

The survey field crew will be on site approximately one day to locate and mark building corners for the
assigned buildings. It is anticipated that four hours will be needed to walk through the site and familiarize
sampling personnel with identified buildings. The survey subcontractor will be on site for a third day to
locate borehole elevation and surface elevation near boreholes. An excel table exhibit will be provided
listing borehole numbers, borehole elevations, as well as surface level elevation.

4.2 Drilling

Once this SAP is approved and prior to drilling, a Ground Penetrating Radar (GPR) operation will be
conducted at each of the dump borehole locations (B-29 through B-33) to ensure we will not encounter
large debris. Following GPR activities, each borehole location will be advanced using direct push
technology (DPT). Soil borings B-1 through B-4 are placed to investigate the UCI Furniture Shop
building. Soil borings B-5 through B-7 are placed to investigate the Timpanogas Vocational Training
Shop. Soil borings B-8 through B-10 are placed to investigate the Flammable Storage Shed. Soil borings
B-11 through B-13 are placed to investigate the Quonset Hut Storage building. Soil borings B-14 through
B-22 are placed to investigate the Motor Pool building and area. Soil borings B-23 through B-25 are
placed to investigate the UCI Welding and Sign Shop. Surface samples M-1, M-2 and M-3 are also
intended to investigate the UCI Welding and Sign Shop. Soil borings B-26 through B-28 are placed to
investigate the Vocational Training building and soil borings B-29 through B-33 are placed to investigate
the dump areas for historical waste disposal purposes. The assigned Environmental Engineer/Scientist
may place additional boreholes to determine subgrade contamination during the sampling event, if in the
Environmental Engineer/Scientist’s professional opinion the additional sampling will be needed to
achieve reasonable subsurface data for possible contamination identification. It is noted that groundwater
is likely below 100 feet at this facility. It is highly unlikely that groundwater will be encountered unless it
is perched on a clay lens or similar.

R&R will contact the local Blue Stakes buried line locator service prior to sampling and request
underground utilities be marked throughout the entire property. Due to the property being on State owned
land, it is unlikely the blue stakes will have any meaningful data to adjust borehole locations. A private
utility clearance using a GPR will be provided by Direct Push Services (DPS) to clear underground
utilities and possible debris within 2-feet of the proposed soil boring locations in the dump areas.

During the direct push process, soil samples will be collected continuously utilizing a macro core sampler
from the ground surface to a maximum depth of approximately 25 feet bgs. If refusal is encountered after
five feet in depth, the borehole will be considered complete. The macro core sampler will be
decontaminated between each boring with a phosphate free detergent such as Alconox and a clean water
rinse, or a clean, new sampler will be used.

During the sampling process a portion of each soil sample interval (typically 5-foot intervals) will be
transferred to a zip-lock type plastic bag and allowed to sit at ambient temperature. After an approximate
five-minute time period of exposure to sunlight or ambient infrared (IR), the headspace in each bag will
be field screened with a portable Photo-Ionization Detector (PID). The soil samples collected from the
borings will be field logged according to soil type (Unified Soil Classification), color, consistency, and
moisture content. Obvious signs of impact (i.e. staining, odor, etc.) will be documented, if encountered, in
any of the five-foot sections during the soil sampling collection effort. PID vapor readings and specific
soil types will be presented on boring logs for the final report.

SUBSURFACE SAMPLING AND ANALYSIS PLAN
Former Draper Prison
Draper, Utah 84020

15
The sample from each soil boring section, registering the highest PID concentration readings will be
submitted for laboratory analysis. If no PID readings register above background levels (5ppm), then the
soil sample collected from near the soil-water table interface, or the lowest possible location in the core,
will be submitted for laboratory analysis. Progression will be in the order listed in the previous sentence.
Upon completion of the soil sampling effort in each borehole, an attempt to collect groundwater samples
will be made from the borings through the drilling rods using dedicated disposable tubing. Water samples
will only be obtained if water is available at the depth achieved in each borehole. An ODEX drill rig will
be on standby to continue coring if we encounter refusal at an inordinate level which is less than 5-feet.

4.3 Sample Aliquots

The volumes of each sample obtained will depend on the respective analyte required and the QA/QC
protocols of the laboratory which are detailed in later sections of this report. Determination of sample
quantity is based on the regulatory drivers associated with each sample type. In the absence of a
regulatory driver, the relevant deciding factors are process knowledge, historical data, and the
Environmental Professional’s experience. Soil and groundwater samples will be obtained as indicated in
this plan and aliquot volumes will fill the containers form the laboratory according to laboratory QQ/QC.
Asbestos samples will be obtained based on regulatory drivers and experience.

4.4 Surface Soil Samples for Priority Pollutant Metals in Soil

Three surface soil samples will be collected near the UCI Welding Shop. The three soil samples will be
obtained from 0-6 inches below ground surface (bgs). The samples will be obtained at the approximate
locations indicated on Figure 5, which is in Appendix A (M-1, M-2, and M-3).

The surface soil samples will be obtained using a new, clean trowel, or similar device. The locations to be
sampled will be directed by the Soil Sampler in accordance with this plan and Figure 5 in Appendix A.
The trowel will be used to dig through the surface soil to achieve the required approximate depths of each
sample. The Soil Sampler will fill each laboratory container with the soil obtained with the trowel.

4.5 Samples for Asbestos in Construction Debris

As construction debris is encountered in the soil borings, if any, the Asbestos Inspector will sample and
assess the suspect asbestos-containing materials (ACM) that are encountered. The inspector will generally
use the Asbestos Hazard Emergency Response Act (AHERA) protocols (adapted for debris) to select and
sample suspect ACM, including selecting the number of samples to be obtained. Sample numbering will
commence with the number 1 and will continue sequentially. Due to possible other constituents in the soils,
the sampler should not touch the materials to be sampled; instead, the Asbestos Inspector should use gloves
while sampling suspect ACM.

A physical assessment will be performed for each homogeneous material identified in the borehole operation.
These physical assessments include evaluating the condition and determining the friability of each material.
Friability is a term used to describe the ease with which a building material inherently lends itself to
disturbance. By definition friable materials are those that can be crushed, pulverized, or reduced to powder by
hand pressure, when dry. Each material identified by the inspector will be further classified into one of three
categories, which have specific sampling requirements:

SUBSURFACE SAMPLING AND ANALYSIS PLAN
Former Draper Prison
Draper, Utah 84020

16
Surfacing Materials Spray-applied or troweled surfaces, such as plaster ceilings and walls,
fireproofing, textured paints, textured plasters, and spray-applied acoustical
surfaces.
Thermal System Insulation Insulation is used to inhibit heat gain or loss on pipes, boilers, tanks, ducts,
and various other building components. surfaces.
Miscellaneous Materials Friable and non-friable products and materials that do not fit in the above
two categories, such as resilient floor covering, baseboards, mastics,
adhesives, roofing material, caulking, glazing, and siding. This category
also contains wallboard and ceiling panels.

The asbestos inspection will be conducted in general accordance with AHERA requirements, using a
minimum number of samples collected from each Homogeneous Area (HA), which also meets the
sampling requirement found in 29 CFR 1926.1101. However, at the discretion of the Asbestos Inspector,
the number of samples obtained may be greater than the minimum required by AHERA. Sample
collection depends on the category that the HA falls into and the amount of material present, as follows:

AHERA GUIDELINES FOR DETERMINING THE NUMBER OF SAMPLES TO TAKE
HA CATEGORY HA SIZE MINIMUM SAMPLES REQUIRED
Surfacing Materials
<1,000 SF 3
1,000–5,000 SF 5
>5,000 SF 7
Thermal System Insulation No Stipulation 3+ (Must also sample all repair patches)
Miscellaneous Materials No Stipulation
Per AHERA, these materials must be sampled "in a
manner sufficient to determine whether or not they
contain asbestos" typically 2–3 samples, based upon
inspector judgement.

If the analytical results indicated that all the samples collected per HA did not contain asbestos, then the HA
(material) would be considered a non-ACM. However, if the analytical results of one or more of the samples
collected per HA indicated that asbestos was present in quantities of greater than 1% asbestos by weight (as
defined by USEPA), the entire suite of the HA (material) would be treated as an ACM regardless of any other
analytical results. Materials which the accredited inspector can visually determine to be non-asbestos
(unpainted metal, glass, wood, etc.) are not required to be sampled.

4.6 Asbestos Sample Locations

Sample locations are selected randomly based on how each represents a homogeneous material. Since
homogeneous areas are limited to the subsurface exploration given to the Asbestos Inspector at any one
time, the representation and number of samples, rather than the exact location of the samples, are the
driving factors.
SUBSURFACE SAMPLING AND ANALYSIS PLAN
Former Draper Prison
Draper, Utah 84020

17
4.7 Changes to PPol Metals Sample Locations Based on Suspect ACM Discovery

If suspect ACM is encountered, the Project Manager may adjust other sample locations to prevent cross
contamination to laboratory samples. Any location adjustments shall be recorded by the Project Manager,
along with the reason the location adjustments were made.

SUBSURFACE SAMPLING AND ANALYSIS PLAN
Former Draper Prison
Draper, Utah 84020

18
5.0 Laboratory Submission, Analysis, and Instrumentation

The details for laboratory analysis and instrumentation are attached in the laboratory Quality Assurance
Plan. Chemtech-Ford Laboratories in Sandy, Utah, will be used for all chemistry sample analysis.
Eurofins Reservoirs Environmental, Inc., in Denver, Colorado, will be used for asbestos analysis.

The following methods are anticipated to be used for the sampling required in the SAP.

Volatile Organic Compounds (VOC) EPA Method 8260
Semi-Volatile Organic Compounds (SVOC) EPA Method 8720
Organophosphate Pesticides (Pesticides) EPA Method 8081
Polychlorinated Biphenyls (PCB) EPA Method 8082
TPH-GRO (Gasoline) EPA Method 4 18.1
TPH-DRO (Diesel) EPA Method 4 18.1
BTEXN EPA Method 8260
Priority Pollutant Metals (Total) EPA Method 6010
Mercury (Total) EPA Method 7471
Asbestos Polarized Light Microscopy (PLM)

SUBSURFACE SAMPLING AND ANALYSIS PLAN
Former Draper Prison
Draper, Utah 84020

19
6.0 SAMPLE HANDLING AND CUSTODY

Establishing and maintaining a fully documented chain of custody for analysis is critical for litigation and
verifiable scientific evaluation. The chain of custody is facilitated by implementing four elements of
documentation: sample labels, chain-of-custody forms, custody seals, and field notebooks.

6.1 Chemistry Samples

Organic chemistry and inorganic chemistry metals samples collected during this project will be labeled
with waterproof labels supplied by the laboratory or written with permanent markers and taped over with
clear tape. Sample containers may also be placed in individual plastic bags to prevent water intrusion onto
the labels. Labels with the sample identification number will be completed or applied as samples are
collected or beforehand.

6.2 Asbestos Samples

Asbestos samples collected during this project will be labeled with a permanent marker directly on the
individual bag holding each sample. Sample containers will be individual resealable plastic bags (e.g.,
Ziploc brand) to prevent the escape of asbestos fibers. Labels with the sample identification number will
be completed or applied as samples are collected or beforehand.

6.3 Field Notebooks

The Project Manager and samplers, or their authorized representative, will use an QA-issued notebook
and indelible blue or black ink to record field activities related to the investigation and other relevant
information about the sample and sampling event. Each entry will begin with the event start time. Below
are more specific items that may be recorded in the field notebook.

• Table of contents
• SAP title
• Statement describing the sampling evolution
• Purpose of the sampling
• Personnel present during the sampling effort
• Sampling methods
• Sample identification number(s)
• Date and time of sample collection
• QC samples obtained
• Field observations
• Sampling equipment used
• Location of the sampling point
• Name of the field contact and/or sampler
• Number and volume of the sample(s) obtained
• Type of material sampled
• Suspected waste composition
• Decontamination of sampling equipment (if used)
• Storage and packing conditions (if different than specified)

SUBSURFACE SAMPLING AND ANALYSIS PLAN
Former Draper Prison
Draper, Utah 84020

20

6.4 Organic and Inorganic Chemistry Sample Storage and Shipping

Once the samples are placed on ice in the storage cooler(s) (~4° Celsius) for non-ACM samples, the
chain-of-custody will undergo the QA/QC process. To the extent possible, the samples (primary and
quality control samples) for an analytical batch will be placed in the same cooler for shipping.

To maintain container requirements and to avoid omitting a sample in the field, the chain-of-custody
forms and sample numbers will be verified against the sample table of numbers and types of samples and
containers, found in 2.1.3 of this Plan.

After containers are filled with the sampled materials, each container will be labeled and returned to the
cooler. Glass bottles may be bubble-wrapped and placed in a resealable plastic storage bag. Once all
bottles are placed in the cooler, packages of ice (prepared by putting ice in a resealable plastic bag,
double-bagging, and securing with duct tape) will be placed between and among the containers. Blue ice
may be placed on top of the cooler. Any excess volume in the cooler will be filled with cushioning
material or additional ice. The cooler will be taped shut and custody sealed. The cooler drain will also be
taped. The shipping labels will be completed and placed on top of the cooler if the cooler is shipped by a
third-party. The cooler may be hand delivered to the laboratory by R&R Environmental, Inc. The chain-
of-custody form will be placed in a resealable plastic storage bag and taped to the top of the cooler. The
sample cooler will be hand delivered to the laboratory by the next business day.

6.5 Asbestos Sample Storage and Shipping

The chain-of-custody and sample numbers will be verified to be sequential and unique. The individual
sample bags will be placed into a larger resealable plastic storage bag. At the end of the day, the samples
will be custody sealed. Should the samples remain off-site prior to shipping, they will be kept in a secure
facility. R&R personnel will then hand deliver the sample package to a Federal Express drop-off location
with a prepaid shipping label and a shipping container for delivery to the contracted laboratory by
overnight express. The chain-of-custody form will be deposited in a resealable plastic storage bag and
placed in the sample package.

Asbestos samples will be placed into plastic containers, double-bagged as batches, and shipped overnight
in a transportation-company-supplied bag.

SUBSURFACE SAMPLING AND ANALYSIS PLAN
Former Draper Prison
Draper, Utah 84020

21
7.0 APPENDICES

Appendix A—MAPS OF WORK AREAS FOR SURVEYING AND SAMPLING
Appendix B—UDEQ CORRESPONDENCE
Appendix C—CHEMTECH-FORD QA MANUAL
Appendix D—EUROFINS RESERVOIRS ENVIRONMENTAL, INC. QA MANUAL
Appendix E—RECORD OF CHANGES (Not Presently Used)

R&R Environmental, Inc.
APPENDIX A

MAP OF WORK AREAS FOR SURVEYING AND SAMPLING
14425 BITTERBRUSH LN S
DRAPER, UT 84020
JULY 2024DRAPER PRISON LOCATION
FIGURE 1
14425 BITTERBRUSH LN S
DRAPER, UT 84020
JULY 2024
DRAPER PRISON FULL MAP
UTD980951727
B33
B32 B31
B30
B29
FIGURE 2
14425 BITTERBRUSH LN S
DRAPER, UT 84020
JULY 2024
DRAPER PRISON BOREHOLE LOCATION MAP
UTD980951727
B4?
B1
B2
B3
= APPROXIMATE BOREHOLE LOCATION ##
FIGURE 3
14425 BITTERBRUSH LN S
DRAPER, UT 84020
JULY 2024
DRAPER PRISON BOREHOLE LOCATION MAP
UTD980951727
B7
B6
B5
##= APPROXIMATE BOREHOLE LOCATION
FIGURE 4
14425 BITTERBRUSH LN S
DRAPER, UT 84020
JULY 2024
DRAPER PRISON BOREHOLE LOCATION MAP
UTD980951727
= APPROXIMATE BOREHOLE LOCATION TBD ##
B11
B10 B9 B8
B13
B12
B20
B19
B16 B21 B18 B15 B17 B14
FIGURE 5
14425 BITTERBRUSH LN S
DRAPER, UT 84020
JULY 2024
DRAPER PRISON BOREHOLE LOCATION MAP
UTD980951727
B26
B27 B28
B23
B24
B25
= APPROXIMATE BOREHOLE LOCATION ##= APPROXIMATE SURFACE SAMPLE LOCATION ##
M-2
M-1
M-3
FIGURE 6
14425 BITTERBRUSH LN S
DRAPER, UT 84020
JULY 2024
DRAPER PRISON SURVEY LOCATION MAP
UTD980951727
F6,4
F6,1
F6,2
F6,3
F6,5
= SURVEY LOCATION ##
F7,3
FIGURE 7
14425 BITTERBRUSH LN S
DRAPER, UT 84020
JULY 2024
DRAPER PRISON SURVEY LOCATION MAP
UTD980951727
##
F7,1
F7,2
= SURVEY LOCATION
FIGURE 8
14425 BITTERBRUSH LN S
DRAPER, UT 84020
JULY 2024
DRAPER PRISON SURVEY LOCATION MAP
UTD980951727
F8,3
F8,4
F8,1
F8,2
F8,5
F8,8
F8,6
F8,7
= SURVEY LOCATION ##
FIGURE 9
14425 BITTERBRUSH LN S
DRAPER, UT 84020
JULY 2024
DRAPER PRISON SURVEY LOCATION MAP
UTD980951727
F9,4
F9,8
F9,5
F9,6
F9,7
F9,9
F9,3
F9,1 F9,2
= SURVEY LOCATION ##

R & R Environmental, Inc.
APPENDIX B

UDEQ CORRESPONDENCE

DSHW-2024-004404 195 North 1950 West • Salt Lake City, UT
Mailing Address: P.O. Box 144880 • Salt Lake City, UT 84114-4880
Telephone [phone] • Fax [phone] • T.D.D. 711
www.deq.utah.gov
Printed on 100% recycled paper
State of Utah

SPENCER J. COX
Governor

DEIDRE HENDERSON
Lieutenant Governor
Department of
Environmental Quality

Kimberly D. Shelley
Executive Director

DIVISION OF WASTE MANAGEMENT
AND RADIATION CONTROL

Douglas J. Hansen
Director

February 1, 2024

Shane Welch, UCI Director
Utah Department of Corrections
1480 North 8000 West
Salt Lake City, UT 84116

RE: Request for More Information Regarding Draper State Prison Closure
UTD980951727 and UTR000017855

Dear Mr. Welch:

Per meetings and subsequent conversations with the Division of Waste Management and Radiation Control
(Division) on December 12, 2023, regarding the large quantity generator closure procedures for the Draper
Prison sites with the associated EPA ID Numbers UTD980951727 and UTR000017855, the Division is
requesting you provide the UST Closure documentation as well as the HazMat Closeout reports indicated in
an email submitted to the Division on December 12, 2023.

These facilities were notified as a Large Quantity Generator of RCRA Hazardous waste. Per Utah
Administrative Code (UAC) R315-262-17, a large quantity generator accumulating hazardous wastes prior to
closing a unit at the facility or prior to closing the facility shall meet all applicable conditions. These
facilities failed to meet the applicable conditions listed under UAC R315-262-17, as such, the Division
requires documentation indicating whether the hazardous wastes that were accumulated on site were shipped
to an appropriate designated facility for disposal, records showing there were no reportable spills while the
facilities were in operation and generating hazardous wastes, and, if there were spills, the Division requires
the reports that were filed for these spills.

If you have any questions, please call Erika Greenwell at 385-499-0346.

Sincerely,

Douglas J. Hansen, Director
Division of Waste Management and Radiation Control
(Over)

DJH/EEG/jk

c: Angela C. Dunn, MD, MPH, Health Officer, Salt Lake County Health Dept.
Dorothy Adams, Deputy Director, Salt Lake County Health Dept.
Ron Lund, Environmental Health Director, Salt Lake County Health Dept.
Shane Welch, UCI Director, Utah Department of Corrections (Email and Hard Copy)
Stephen Galley, R&R Environmental, Inc. (Email)
Dave Roskelley, R&R Environmental, Inc. (Email)
Steve Smith, R&R Environmental, Inc. (Email)
Mike Ambre, Deputy Director, DFCM, Utah Department of Government Operations (Email)
Jon Vance, Program Manager, DFCM, Utah Department of Government Operations (Email)
Aubrey Virgin, Intern, DFCM, Utah Department of Government Operations (Email)
Bob Kempe, Facilities Coordinator, Utah Department of Corrections (Email)
Paige Walton, Division of Waste Management and Radiation Control,
Utah Department of Environmental Quality

R & R Environmental, Inc.
47 West 9000 South, Suite #2, Sandy, Utah 84070 [phone]: Office  [phone]: Fax www.rrenviro.com

May 10, 2024

Ms. Deborah Ng
Hazardous Waste Manager
Hazardous Waste Section
Division of Waste Management and Radiation Control
Utah Department of Environmental Quality
195 North 1950 West
Salt Lake City, Utah 84114-42894
Sent via email: [e-mail]

Re: Draper State Prison RCRA Closure
Waste Information
EPA ID Number UTR000017855

Dear Ms. Ng:

In response to the State of Utah, Department of Environmental Quality, Division of Waste
Management and Radiation Control, request for refinement of the submitted form 8700 data, the
following additional information is provided regarding removal of waste from the site for closure.

The manifest data from the waste removal action at the Draper Prison was examined in detail to
determine accurate quantities of wastes that were removed from the site. The review of the data
indicated an estimated 13% of manifest data was not readable, or the information was indeterminant.
Therefore, the indicated quantities in this letter are estimated to be 13% below actual quantities that
were removed.

The waste information below indicates waste that was removed from the facility, less the estimated
13% shortfall indicated above. It is additionally noted; this data is presented by “Work Group”. The
data was left in the respective Work Groups so that if required, we may identify the contractor that
conducted the actual removal.

Manifests / Receipts

WG 1 Waste Manifests

Metro Group, Inc. (Control numbers: 1404121, 1405345, 1402509, 1404445)
#1 Copper Wire- 4 lbs.
#2 Copper Wire- 484 lbs.
Steel Sheet / Tin- 8750 lbs.
Ballasts – Non-PCB- 975 lbs.
Alternators- 28 lbs.

Page | 2

Batteries (auto & truck)- 383 lbs.
Copper Transformers Small- 289 lbs.
Dirty Aluminum- 869 lbs.
Circuit Boards- 18 lbs.
BX Wire- 9 lbs.

Utah Metal, Works Inc.
Electronic Brkg-low grade- 8210 lbs. (ID 4/6
Steel- 470 lbs.
Reg Batteries- 50 lbs.
Reg Ballasts- 90 lbs.

Wasatch Propane, Inc.
“Propane tanks were dropped oof to be recycled at Wasatch propane on 10/11/22” –
thanks Kelsey.

Waste Control Management
Non-friable- 5000, 7540, 4500 lbs. / 80, 10, 90, 15, 6, 42, 20, 1, bags / 8 barrels / 5.5, 7,
7, 7, 15, 15, 15, 15, 15, 7, 8, 15, 15, cubic yards /
Friable- 80 bags,

CAT Scale- 14814 S Minuteman Dr, Draper UT
16000, 12960 lb.

Waste Management Mountain View Landfill
Non-friable-
Friable- 125, 80, Bags / 10, 20, 7, cubic yards

US Ecology – EPA ID # UTR0000017855
EPA ID- UTD98807412 / IDD073114654
- Manifest # 023049977 JJK – D002 (sodium hydroxide) 6 DF 900 P, (sulfuric
acid) 1 DF 200 P / D001 D018 D035 (isopropanol, methanol) 5 DM 1000 P / D001
D035 (waste Paint related material) 1 CF 800 P

- Manifest # 023049978 JJK – D001 D035 (waste paint related material) 5 DM
2400 P / D001 (waste propane) 1 DF 40 P / D009 (mercury & fire extinguishers) 5
DM 500 P

- Manifest # 023049979 JJK – Aerosol Cans 3 DM 300 P / Spent Road Flares 1 DF
20 P / Non Haz Liquids 2 CF 1600 P / Non Haz Maintenance liquids 2 CF 1600 P

- Manifest # 023049980 JJK – Non Haz maintenance liquids 7 DM 2800 P / Non
Haz maintenance liquids 2 DF 800 P

Page | 3

Veolla Environmental Services (EPA ID # - UTD988074712 / AZ0000337360)
Tracking number - 800SUW-12/23/01
Universal Waste Mercury Articles 1 DF 10 P
Universal NiCad Batteries 1 DF 20 P
Universal Mixed Batteries 1 DF 60 P
Universal Waste Non-OCB Capacitors 1 DM 450 P
Electronic Waste 1 DF 25 P

WG 2_3 Waste Manifests & Updated WG 2_3 Waste Manifests

ArcBest
Recycled Electronics – 1200 lbs.

A-Gas (Rapid Recovery) – reference # 00308853
8 Refrigerant recovery services

US Ecology – EPA ID # UTR0000017855 / EPA ID- UTD98807412 / IDD073114654
- Manifest # 024560239 JJK – D002 29 DF 2543 lbs. / D002 12 DF 1000 P / D001
D018 D035 10 DM 8000 P / 3 CF 1500 KG
- Tracking Number 7878-1/6-01
Cleaning Chemicals 11 CF 11000 P
Maintenance Fluids 3 CF 3000 P
Non-haz paints 4 CF 4000 P
Non-haz Solids 4 CF 5000 P

4 MX-7000 (8698.20/10,234)
Security system/pyscon
3 x-ray scanners (21,3750)
5 x-ray systems (15,500)
2 provision 2 body scanners (150,470)
1 L3 Provision 2 body scanner (150,470)

Veolla Environmental Services (EPA ID # - UTD988074712 / AZ0000337360)
Tracking number – 7878UW-PU01
Electronic Waste 24 CF 24000 P
Tracking number – 7878UW-11/9-01
Universal Waste – Electronic waste 24 CF 24000 P
Tracking number – 7878UW-2/8-01
Light Tubes 13 CF 4500 P
HID Bulbs 2 CF 1000 P
5 CF 10000 P
Electronic Waste with Monitors 10 CF 1800 P

Mountain View Landfill
Job # 23458

Page | 4

- 32552, 32549, 32551, 32550, 32744, 32743, 32745, 32742, 32741, 32774, 32779,
32775, 32776, 32780, 32781, 32778, 32777
Job # 23457
- 32530, 32531, 32532, 32733, 32732, 32734, 32529, 32735, 32785, 32784, 32782,
32783, 32791, 32792, 32794, 32793, 32795, 32797, 32796, 32798, 32739, 32740,
32736, 32737, 32738 (30 cubic yards N.F), 32847, 32844, 32843, 32846, 32852,
32851, 32849, 32850, 32848, 32845,

Other Email Attachments

US Ecology
Tracking number - 7878-2/22-01
Cleaning Chemicals – 5 CF 700 P
Maintenance Fluids 13 CF 500 P
Non-Haz Paints 1 CF 1000 P
Non-Haz Maintenance Fluids 6 DM 1600 P
Tracking number 7878-W01
Non-Haz Solids 1 DM 400 P
Aerosol Cans 1 DM 200 P
Tracking number - 7878-2/22-02
Aerosol Cans 11 DM 2200 P
Non-Haz liquids 1 DF 100 P
Non-Haz Cleaning Chemicals 6 DF 300 P
Non-Haz Cleaning Chemicals 3 CF 600 P
Tracking number – 024560238 JJK
D001 Propane 1 DF 75 P
D001 Compressed Oxygen 1 DM 75 P
Fire Extinguishers 1 CF 650 P
D001, D018, D035 Waste liquids 1 CF 200 P
Tracking number - 024560248 JJK
D001, D035 Waste Paint Related Material 89 DM 3200 P
D001, D035 Waste Paint Related Material 3 CF 500 P
Non-Haz Solids 1 DM 500 P
Tracking number – 024560239 JJK
D002 Waste Corrosive Liquid, Basic, Inorganic (S.H) 29 DF 5600 P
D002 Waste Corrosive Liquid, Basic, Inorganic (S.A) 12 DF 1400 P
D001, D018, D035 (Isopropanol, Methanol) 10 DM 3000 P
D001, D018, D035 Polychlorinated Biphenyls 3 CF 700 Kg

Waste Management
Manifest # 6707168
2780 lbs. / 75 bags / 6 cubic yards

A-Gas (Rapid Recovery)

Page | 5

Ref # 00309896
11 Refrigerant Recovery Services
Ref # 00309895
4 Refrigerant Recovery Services

Utah Metal Works
Electronic Ballasts 90 lbs.
Steel 174 lbs.

Email with photos

Waste Control Management
# - 15363 Non-friable - 90 bags
# - 15610 Non-friable – 10 bags / 8 barrels
# - 15634 Friable – 80 bags
# - 15615 Non-friable - 7 cubic yards

We appreciate the opportunity to perform these services. Should you have any questions or require
additional information, please do not hesitate to contact the undersigned at [e-mail] or
call [phone].

Sincerely,
R & R Environmental, Inc.

Stephen S. Galley, CSP
Environmental Division Director

c: Raymond Mixon, State of Utah, Attorney General
Shawn Anderson, State of Utah, Department of Corrections
Bob Kempe, State of Utah, Department of Corrections
Shane Welch, State of Utah, Department of Corrections
Aubrey Stapel, State of Utah, Division of Facilities, Construction, and Management
John Vance, State of Utah, Division of Facilities, Construction, and Management
Doug Hansen, State of Utah, DEQ, Division of Waste Management & Radiation Control
Stevie Norcross, State of Utah, DEQ, Division of Waste Management & Radiation Control
Paige Walton, State of Utah, DEQ, Division of Waste Management & Radiation Control
Dave Roskelley, R&R Environmental, Inc.
Steven B. Smith, R&R Environmental, Inc.

DSHW-2024-003012 195 North 1950 West • Salt Lake City, UT
Mailing Address: P.O. Box 144880 • Salt Lake City, UT 84114-4880
Telephone [phone] • Fax [phone] • T.D.D. 711
www.deq.utah.gov
Printed on 100% recycled paper
State of Utah

SPENCER J. COX
Governor

DEIDRE HENDERSON
Lieutenant Governor
Department of
Environmental Quality

Kimberly D. Shelley
Executive Director

DIVISION OF WASTE MANAGEMENT
AND RADIATION CONTROL

Douglas J. Hansen
Director

June 19, 2024

Shane Welch, UCI Director
Utah Department of Corrections
1480 North 8000 West
Salt Lake City, UT 84116

RE: Large Quantity Generator Closure - Draper Prison Locations
UTD980951727 and UTR000017855

Dear Mr. Welch:

The Director of the Division of Waste Management and Radiation Control (Director) has evaluated
information relating to the two large quantity generator (LQG) locations at the Utah Department of
Corrections (UDC) Draper Prison Site, located at 14072 South Pony Express Road, Draper, Utah,
EPA ID No. UTD980951727 (Facility 1) and 14425 Bitterbrush Lane, Draper, Utah, EPA ID No.
UTR000017855 (Facility 2). Based on the following, the Director is requesting information from UDC
regarding Facility 1 and Facility 2.

Facility 1, EPA ID No. UTD980951727.

The following facts apply to Facility 1:

1. On July 16, 1984, UDC notified as an LQG of hazardous waste on EPA Form 8700-12 and
notified of management of D001, F002, and F003 wastes.

2. On February 19, 2004, UDC re-notified as a Small Quantity Generator (SQG) managing D001,
F002, and F003 wastes.

3. During a 2008 inspection, the Director’s representatives (inspectors) and Environmental
Protection Agency (EPA) representatives identified spills and mismanagement of containers
(DSHW-2008-007561).

(Over)
Page 2

4. During a 2016 inspection, inspectors identified mismanagement of containers
(DSHW-2016-010264). Also, the notification to the local hospital sent by UDC’s
Safety/Compliance representative identified additional wastes, including:

“Paint waste with Benzene, Acetone, Toluene, Xylene Press Wash waste with Petroleum
Distillates, Xylenes, Aliphatic Solvent Naphtha”

5. On April 8, 2024, per the Director’s request, UDC (1) re-notified as an SQG managing D001,
F003, and F005 wastes and (2) notified of closure of Facility 1, which was two years after the
required LQG closure notification requirements in Utah Admin. Code R315-262-17(a)(8).
UDC also indicated that it was not in compliance with the performance standards in 40 C.F.R.
262.17(a)(8) and Utah Admin. Code R315-262-17(a)(8)(iii).

6. Between February 2024 and May 2024, the Director received documentation from UDC,
including sampling and soil boring analyses from the removal of Underground Storage Tanks,
hazardous waste manifests of containers shipped off site, and a map of the operation areas.

7. UDC did not properly notify the Director, and inspectors were therefore unable to inspect
Facility 1 prior to demolition.

8. UDC has not met the LQG closure requirements for Facility 1 specified in Utah Admin. Code
R315-262-17(a)(8).

Based on the Director’s evaluation of the following, Facility 1 should be closed in one of the three ways
specified below.

Within 30 days of the date of this letter, please inform the Director of whether UDC will close Facility
1 by (1) closing in accordance with the clean closure standards under Utah Admin. Code
R315-262-17(a)(8); (2) closing as a landfill with post-closure monitoring; or (3) entering into an
administrative order to perform risk-based closure of Facility 1 in accordance with Utah Admin. Code
R315-101.

Facility 2, EPA ID No. UTR000017855.

Based on the Director’s evaluation of the following, the Director is requesting additional information
from UDC regarding Facility 2 as specified below.

1. On August 23, 2022, UDC notified as an LQG managing D009, F001, F002, F003, F004, F005,
and F008 wastes.

2. On April 5, 2024, per the Director’s request, UDC re-notified of its closure of Facility 2 on
July 18, 2022, which was beyond the notification timeframes for LQGs required by Utah Admin.
Code R315-262-17(a)(8).

Within 30 days of the date of this letter, please provide a detailed description of (1) why UDC notified
as an LQG on August 23, 2022; and (2) if waste was generated at Facility 2, whether the waste was
hazardous or non-hazardous and how UDC made such determination.

Page 3

All information regarding the requests in this letter, should be addressed to the Director at the following:

If by U.S. Mail, to the following address:
Douglas J. Hansen, Director
Division of Waste Management and Radiation Control
P.O. Box 144880
Salt Lake City, UT 84114-4880

If by email, to the following address:
[e-mail]

If you would like to discuss these options further, please contact Deborah Ng, Hazardous Waste
Program Manager, at 385-499-0837 or by email at [e-mail] to arrange a meeting.

Sincerely,

Douglas J. Hansen, Director
Division of Waste Management and Radiation Control

DJH/DSN/wa

c: Dorothy Adams, Interim Health Officer, Salt Lake County Health Dept.
Ron Lund, Environmental Health Director, Salt Lake County Health Dept.
Eric Peterson, Environmental Health Deputy Director, Salt Lake County Health Dept.
Annette Maxwell, U.S. EPA Region 8
Shane Welch, UCI Director, Utah Department of Corrections (Email and Hard Copy)
Mike Ambre, Interim Director, DFCM, Utah Department of Government Operations (Email)
Jon Vance, Project Manager, DFCM, Utah Department of Government Operations (Email)
Aubrey Stapel, Hazmat Program Manager, DFCM, Utah Department of Government Operations
(Email)
Bob Kempe, Facilities Bureau Correctional Administrator, Utah Department of Corrections
(Email)
Stephen Galley, R&R Environmental, Inc. (Email)
Dave Roskelley, R&R Environmental, Inc. (Email)
Steve Smith, R&R Environmental, Inc. (Email)
Stevie Norcross, PhD, Asst. Director, Div. of Waste Management and Radiation Control, UDEQ
Brenden Catt, Assistant Attorney General, Utah Attorney General’s Office
Paige Walton, Division of Waste Management and Radiation Control, UDEQ
Jay Morris, Division of Air Quality, UDEQ
Morgan Atkinson, Division of Environmental Response and Remediation, UDEQ
R & R Environmental, Inc.
47 West 9000 South, Suite #2, Sandy, Utah 84070 [phone]: Office  [phone]: Fax www.rrenviro.com
July 8, 2024

Mr. Douglas J. Hansen
Director
Division of Waste Management and Radiation Control
P.O. Box 144880
Salt Lake City, Utah 84114-4880
Sent via email: [e-mail]

Re: Response to the State of Utah, Department of Environmental Quality,
Division of Waste Management and Control Letter, DSHW-2024-003012, dated
June 19, 2024, regarding Facility 2, EPA ID No. UTR000017855

Dear Mr. Hansen:

The Division of Waste Management and Radiation Control letter (DSHW-2024-003012), dated June 19, 2024,
has been received by Utah Department of Corrections (UDC), Utah Correctional Industries (UCI), and the
Division of Facilities, Construction, and Management. It is noted that DEQ, UDC, UCI, and DFCM are all
entities of the State of Utah. R&R Environmental, Inc. (R&R) is responding to the request for information
indicated in the referenced letter on behalf of, and with the approval of UDC and UCI, through DFCM.

In the DSHW-2024-003012 letter, the following was indicated:

Interrogative:
“Within 30 days of the date of this letter, please provide a detailed description of (1)
why UDC notified as an LQG on August 23, 2022; and (2) if waste was generated at
Facility 2, whether the waste was hazardous or non-hazardous and how UDC made such
determination.”

Response:
(1) UDC, through DFCM, did request a RCRA LQG status in August 2023. This request
was made due to a planned relocation and demolition of the Draper Prison facility. The
thought process for this registration was: the universal and hazardous waste that required
removal from the facility would need to go under a separate cover from the existing
building wastes which may have different waste codes.

(2) Waste was not generated at the facility. However, existing building demolition
wastes, which were classified as both Universal and Hazardous wastes, were removed
from the structures prior to demolition, to facilitate the demolition of the facility.
Additional wastes in the facility that were generated as part of the existing RCRA LQG
status were also removed prior to demolition.

The wastes removed from the facility to facilitate demolition were both hazardous
and nonhazardous. The waste was initially identified by R&R and documented. The
waste was then removed via multiple environmental contractors and their qualified
subcontractors while being overseen by R&R. The waste was characterized by the
subcontracting companies for transportation and disposal prior to removal from the site.
All waste removed from the site was documented on manifests and supplied to DEQ
under separate cover.

2 | Page

Based on the information contained in this letter and based on the fact there is another LQG with an EPA ID
No. associated with the facility, UDC, UCE, and DFCM formally request that EPA ID No. UTR000017855
be closed without any additional testing. It is further noted, the facility will be evaluated under EPA ID No.
UTD980951727.

R&R appreciates the opportunity to provide these environmental services. Should you have any questions or
require additional information, please do not hesitate to contact the undersigned at [phone] or
[e-mail].

Sincerely,

R & R Environmental, Inc.

Stephen S. Galley, CSP
Environmental Division Director

C: Dorothy Adams, Interim Health Officer, Salt Lake County Health Dept.
Ron Lund, Environmental Health Director, Salt Lake County Health Dept.
Eric Peterson, Environmental Health Deputy Director, Salt Lake County Health Dept.
Annette Maxwell, U.S. EPA Region 8
Shane Welch, UCI Director, Utah Department of Corrections
Mike Ambre, Interim Director, DFCM, Utah Department of Government Operations
Jon Vance, Project Manager, DFCM, Utah Department of Government Operations
Aubrey Stapel, Hazmat Program Manager, DFCM, Utah Department of Government Operations
Bob Kempe, Facilities Bureau Correctional Administrator, Utah Department of Corrections
Dave Roskelley, R&R Environmental, Inc.
Steve Smith, R&R Environmental, Inc.
Stevie Norcross, PhD, Asst. Director, Div. of Waste Management and Radiation Control, UDEQ
Brenden Catt, Assistant Attorney General, Utah Attorney General’s Office
Deborah Ng, Program Manager, Division of Waste Management and Radiation Control, UDEQ
Paige Walton, Division of Waste Management and Radiation Control, UDEQ
Jay Morris, Division of Air Quality, UDEQ
Morgan Atkinson, Division of Environmental Response and Remediation, UDEQ
R & R Environmental, Inc.
47 West 9000 South, Suite #2, Sandy, Utah 84070 [phone]: Office  [phone]: Fax www.rrenviro.com
July 8, 2024

Mr. Douglas J. Hansen
Director
Division of Waste Management and Radiation Control
P.O. Box 144880
Salt Lake City, Utah 84114-4880
Sent via email: [e-mail]

Re: Response to the State of Utah, Department of Environmental Quality,
Division of Waste Management and Control Letter, DSHW-2024-003012, dated
June 19, 2024, regarding Facility 2, EPA ID No. UTR000017855

Dear Mr. Hansen:

The Division of Waste Management and Radiation Control letter (DSHW-2024-003012), dated June 19, 2024,
has been received by Utah Department of Corrections (UDC), Utah Correctional Industries (UCI), and the
Division of Facilities, Construction, and Management. It is noted that DEQ, UDC, UCI, and DFCM are all
entities of the State of Utah. R&R Environmental, Inc. (R&R) is responding to the request for information
indicated in the referenced letter on behalf of, and with the approval of UDC and UCI, through DFCM.

In the DSHW-2024-003012 letter, the following was indicated:

Interrogative:
“Within 30 days of the date of this letter, please provide a detailed description of (1)
why UDC notified as an LQG on August 23, 2022; and (2) if waste was generated at
Facility 2, whether the waste was hazardous or non-hazardous and how UDC made such
determination.”

Response:
(1) UDC, through DFCM, did request a RCRA LQG status in August 2023. This request
was made due to a planned relocation and demolition of the Draper Prison facility. The
thought process for this registration was: the universal and hazardous waste that required
removal from the facility would need to go under a separate cover from the existing
building wastes which may have different waste codes.

(2) Waste was not generated at the facility. However, existing building demolition
wastes, which were classified as both Universal and Hazardous wastes, were removed
from the structures prior to demolition, to facilitate the demolition of the facility.
Additional wastes in the facility that were generated as part of the existing RCRA LQG
status were also removed prior to demolition.

The wastes removed from the facility to facilitate demolition were both hazardous
and nonhazardous. The waste was initially identified by R&R and documented. The
waste was then removed via multiple environmental contractors and their qualified
subcontractors while being overseen by R&R. The waste was characterized by the
subcontracting companies for transportation and disposal prior to removal from the site.
All waste removed from the site was documented on manifests and supplied to DEQ
under separate cover.

2 | Page

Based on the information contained in this letter and based on the fact there is another LQG with an EPA ID
No. associated with the facility, UDC, UCE, and DFCM formally request that EPA ID No. UTR000017855
be closed without any additional testing. It is further noted, the facility will be evaluated under EPA ID No.
UTD980951727.

R&R appreciates the opportunity to provide these environmental services. Should you have any questions or
require additional information, please do not hesitate to contact the undersigned at [phone] or
[e-mail].

Sincerely,

R & R Environmental, Inc.

Stephen S. Galley, CSP
Environmental Division Director

C: Dorothy Adams, Interim Health Officer, Salt Lake County Health Dept.
Ron Lund, Environmental Health Director, Salt Lake County Health Dept.
Eric Peterson, Environmental Health Deputy Director, Salt Lake County Health Dept.
Annette Maxwell, U.S. EPA Region 8
Shane Welch, UCI Director, Utah Department of Corrections
Mike Ambre, Interim Director, DFCM, Utah Department of Government Operations
Jon Vance, Project Manager, DFCM, Utah Department of Government Operations
Aubrey Stapel, Hazmat Program Manager, DFCM, Utah Department of Government Operations
Bob Kempe, Facilities Bureau Correctional Administrator, Utah Department of Corrections
Dave Roskelley, R&R Environmental, Inc.
Steve Smith, R&R Environmental, Inc.
Stevie Norcross, PhD, Asst. Director, Div. of Waste Management and Radiation Control, UDEQ
Brenden Catt, Assistant Attorney General, Utah Attorney General’s Office
Deborah Ng, Program Manager, Division of Waste Management and Radiation Control, UDEQ
Paige Walton, Division of Waste Management and Radiation Control, UDEQ
Jay Morris, Division of Air Quality, UDEQ
Morgan Atkinson, Division of Environmental Response and Remediation, UDEQ

R & R Environmental, Inc.
APPENDIX C

CHEMTECH-FORD QA MANUAL
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.
Quality Manual
Only documents located on the intranet are controlled. All other forms
are uncontrolled.
Effective
Date:
10/01/2017
Rev:
27
Chemtech-Ford Laboratories Quality Manual Page No.
3 of 139
Prepared by: Ron Fuller Reviewed by: Paul Ellingson
Approved for
affiliate
laboratory use
Status: Active
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
Quality Manual
Only documents located on the intranet are controlled. All other forms
are uncontrolled.
Effective
Date:
10/01/2017
Rev:
27
Chemtech-Ford Laboratories Quality Manual Page No.
4 of 139
Prepared by: Ron Fuller Reviewed by: Paul Ellingson
Approved for
affiliate
laboratory use
Status: Active
5.9 Assuring the Quality of Test and Calibration Results
5.10 Reporting the Results
Quality Manual
Only documents located on the intranet are controlled. All other forms
are uncontrolled.
Effective
Date:
10/01/2017
Rev:
27
Chemtech-Ford Laboratories Quality Manual Page No.
5 of 139
Prepared by: Ron Fuller Reviewed by: Paul Ellingson
Approved for
affiliate
laboratory use
Status: Active
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
Quality Manual
Only documents located on the intranet are controlled. All other forms
are uncontrolled.
Effective
Date:
10/01/2017
Rev:
27
Chemtech-Ford Laboratories Quality Manual Page No.
6 of 139
Prepared by: Ron Fuller Reviewed by: Paul Ellingson
Approved for
affiliate
laboratory use
Status: Active
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.
Quality Manual
Only documents located on the intranet are controlled. All other forms
are uncontrolled.
Effective
Date:
10/01/2017
Rev:
27
Chemtech-Ford Laboratories Quality Manual Page No.
7 of 139
Prepared by: Ron Fuller Reviewed by: Paul Ellingson
Approved for
affiliate
laboratory use
Status: Active
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.
Quality Manual
Only documents located on the intranet are controlled. All other forms
are uncontrolled.
Effective
Date:
10/01/2017
Rev:
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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
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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
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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.
Quality Manual
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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
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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
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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
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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
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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
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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.

R & R Environmental, Inc.
APPENDIX D

EUROFINS RESERVOIRS ENVIRONMENTAL, INC. QA MANUAL

STATEMENT
OF
QUALIFICATIONS

TABLE OF CONTENTS

1.0 INTRODUCTION
2.0 QUALITY ASSURANCE / QUALITY CONTROL (QA/QC)
3.0 OBJECTIVE OF THE QUALITY ASSURANCE PROGRAM
4.0 QA/QC PROCEDURES FREQUENCY CHART
5.0 TYPES OF ANALYSES (SUMMARIZED)
5.1 Air Sample Analysis by Transmission Electron Microscopy
5.2 Air Sample Analysis by Phase Contrast Microscopy
5.3 Bulk Sample Analyses by Transmission Electron Microscopy
5.4 Bulk Sample Analysis by Polarized Light Microscopy
5.5 Water Sample Analyses by Transmission Electron Microscopy
5.6 Metal Sample Analysis by Atomic Absorption Spectroscopy
5.7 Water/Soil/Waste Sample Analysis by Gas Chromatography
5.8 Pathogenic Bacteria Sample Analysis
5.9 Spoilage and Indicator Bacteria Analysis
6.0 INSTRUMENTATION
7.0 PERSONNEL QUALIFICATIONS
8.0 ACCREDITATION AND LICENSES
8.1 NVLAP Accreditation for TEM/PLM
8.2 AIHA LAP-IHLAP Accreditation for PCM
8.3 AIHA LAP-IHLAP Accreditation for Metals
8.4 AIHA LAP-ELLAP Accreditation of Lead
8.5 Food Laboratory Accreditation Program (FoodLAP)
8.6 State of Colorado Department of Public Health and Environment for Microbiology

9.0 REPRESENTATIVE PROJECT EXPERIENCE
10.0 CHAIN OF CUSTODY
11.0 CERTIFICATIONS

1.0 INTRODUCTION
Located in Denver, CO, Reservoirs Environmental, Inc is a full-service environmental testing laboratory
specializing in Asbestos, Organic, Inorganic and Microbiological analyses. For nearly two decades, we have
provided analytical services to the Rocky Mountain Region, national and international clientele. Founded in
1987 in response to an increasing industry demand for quality analytical services in the environmental and
industrial hygiene industries, Reservoirs has many years of experience in applied research and mineral
identification. Reservoirs Environmental, Inc. continues to provide innovative technical expertise and
comprehensive analytical testing services for state and local government agencies, consulting firms, public
utilities, private owners, building contractors, and school districts. As we continue to expand our capabilities to
meet the increasing environmental needs of the business community, Reservoirs Environmental, Inc. is
committed to meet those needs with the highest level of service and support.

2.0 QUALITY ASSURANCE/QUALITY CONTROL (QA/QC)
As samples arrive at Reservoirs for analysis, a Reservoirs Chain of Custody (COC) document is reviewed
and signed (see Section 10). If a COC does not accompany samples received, one will be initiated by the
sample receiving coordinator. To complete the COC, each job is assigned a RES job number (RES #) which
will appear on the client's report and invoice. In addition to the RES job number, each individual sample
within a job is assigned an internal tracking number (EM #). These numbers are used throughout the
preparation and analysis of the sample. Internal tracking numbers help eliminate any possible bias within the
lab.
The final report provided to the client includes tables showing:
ꞏ Total mineral / analyte concentration
ꞏ Customer provided sample information
ꞏ Method used in the analyses
ꞏ Copy of the Chain of Custody
ꞏ Copies of count sheets (If Applicable)
Final reports are stored on computer and paper copy for future reference by the client.
ASBESTOS: 
Reservoirs has established a QA/QC program that assures the integrity of analyses performed on air, bulk,
and water samples. This program is specifically tailored to the asbestos industry, and conforms with or
exceeds the minimum laboratory requirements for sample receiving, preparation, analysis and reporting
required by the U.S. Environmental Protection Agency (USEPA). Our quality control program guarantees
precision within the laboratory and accuracy of all analyses. All analysts participate in routine analysis of re-
preps, recounts, verified counts and blind samples. Each analyst and all laboratory procedures are checked
using periodic training, counting standards, proficiency testing samples, inter-laboratory sample exchange,
mineral standards review, and NIST standards.
Reservoirs is fully accredited by NVLAP for airborne asbestos fiber analysis and bulk asbestos fiber analysis
(NVLAP Lab Code 101896-0). Reservoirs is also accredited for industrial hygiene asbestos samples through
the AIHA LAP Industrial Hygiene Laboratory Accreditation Program (AIHA LAP 101533).
METALS:
The QA/QC program for metals analysis conforms to current EPA, HUD and NIOSH requirements for metals
in air, bulks, wipes and water samples. Reservoirs is AIHA LAP accredited (AIHA LAP 101533) for lead in
environmental matrices, paint, soil, and wipes through the AIHA LAP Environmental Lead Laboratory
Accreditation Program (ELLAP), and metals in air through the AIHA LAP. IHLAP Industrial Hygiene
Laboratory Accreditation Program (IHLAP).
Our Quality Control program uses measures necessary to monitor the laboratory's analytical program in
order to ensure data produced meets the requirements of the client and standards set by the laboratory.
Standard Operating Procedures (SOP) are in place for all analyses performed.
The accuracy and precision of data is determined by use of reference samples, commercially obtained
NIST/NBS standards, and recovery data including calibration checks, spikes, duplicates, replicates and
blanks. Corrective action procedures are incorporated into the QA/QC program.

ORGANICS:
The organics laboratory operates under a QA/QC program which conforms to or exceeds the minimum
laboratory requirements for sample receiving, preparation, analysis, and reporting required by the U.S.
Environmental Protection Agency (USEPA). The laboratory holds AIHA LAP accreditation (AIHA LAP
101533) and is proficient in all environmental testing rounds provided by Environmental Resource
Associates (ERA).
The data generated is in strict accordance with this QA/QC program and meets all client requirements
and the standards set up by the laboratory. Accuracy and precision is determined by statistical evaluation
of the data generated using NIST traceable standards, calibration checks, spikes, duplicates, replicates,
and blanks.
MICROBIOLOGY:
The microbiology laboratory has an established QA/QC program that ensures the integrity of analyses
preformed on environmental and food samples of various matrices. This program is customized with stringent
attention to rid contamination and complies with ISO 17025, AIHA-LAP, AOAC, CDC, and state guidelines
and methods.
All analyses and data are held to strict quality requirements. Before final reports are released, all data
packages are reviewed and approved by our quality assurance department, thereby ensuring an
independent review of the original work for additional verification.
We are exceedingly committed to quality. Reservoirs microbiology laboratory participates in numerous
proficiency rounds per year and rigorous internal quality control procedures. The high standard of data is
ensured by the use of commercially obtained certified reference cultures (CRC), replicates, and blanks.
Intensive corrective action protocols are incorporated into the QA/QC program.
Reservoirs is AIHA-LAP accredited (AIHA LAP 101533) for microbiology analyses through the FOOD
Laboratory Accreditation Program (FoodLAP), the Environmental Microbiology Laboratory Accreditation
Program (EMLAP) and the CDC Elite program.

3.0 OBJECTIVE OF THE QUALITY ASSURANCE PROGRAM

The objective of Reservoirs’ Quality Assurance (QA) Program is to assure the scientific reliability of all
laboratory data. Management, administrative, statistical, and investigative techniques, as well as preventive
and corrective actions maximize the reliability of the data. Quality, as defined in the following document, is
accurate and reproducible analytical data. Specific QA objectives are:
ꞏ To develop and initiate QA methodologies capable of meeting the laboratory’s need for precision and
accuracy.
ꞏ To validate and improve laboratory procedures necessary to comply with performance standards.
ꞏ To characterize the laboratory’s analytical performance level.
ꞏ To ensure that individual analysts, as well as the entire laboratory, meet established performance
levels set by the QA/QC department.
ꞏ To maintain consistently high levels of quality at all levels of the laboratory including: sample
tracking, sample preparation, equipment calibration and maintenance, sample analysis, report
generation, reporting of data and sample storage.
ꞏ To participate in inter-laboratory QA programs to achieve and maintain consistently high levels of
quality.
It is the responsibility of the QA/QC department to ensure that the laboratory meets these objectives.

4.0 QA/QC PROCEDURES FREQUENCY CHART
ADMINISTRATIVE
Action Performed Each Sample Each Job As Required
Report Generation X
Chain of Custody X
Sample Tracking X X
Data Entry X X
Recalculate Results X

TEM LABORATORY & PERSONNEL
Action Performed Each
Sample
Each
Job
10% Daily Monthly Yearly As
Required
Equipment and Supplies Contamination
Check X
Grid Opening Size (TEM) X
Precision / Accuracy (Repreps, Recounts
and Laboratory Blanks etc.) X
Equipment Calibration X X
Equipment Maintenance X 4 X X
Laboratory Blank X
Multiple Grid Preparations X
Air Monitoring 4X
Proficiency Analytical Testing Samples X X
S.A.E.D Photo & Indexing (TEM) X X
1876b(e) X
Mineral Standards Review X

METALS LABORATORY & PERSONNEL
Action Performed Batch Daily Quarterly As Required Yearly
Equipment and Supplies Contamination
Check
X
Quality Control Samples (Precision /
Accuracy)
X
Equipment Calibration X X X
Equipment Maintenance X
Initial Demonstration of Capability X
Laboratory Preparation Blank X
Air Monitoring X
Method Detection Limits X X
Proficiency Analytical Testing Samples X X

PCM LABORATORY & PERSONNEL
Action Performed 1% 10% Daily Monthly Quarterly Yearly As
Required
Equipment and Supplies Contamination
Check
X
Precision / Accuracy (Recounts / Counting
Standard, etc.)
X
Equipment Calibration / Alignnment X X
Equipment Maintenance X X
Laboratory Blank X
Round Robin 2 X
Counting Standards (1 of 20 samples) X
Air Monitoring X X
Proficiency Analytical Testing Samples X

PLM LABORATORY & PERSONNEL
Action Performed Each
Sample
2% 10% Daily Weekly Quarterly Yearl
y
As
Required
Monthly
Equipment and Supplies Contamination
Check
X
Refractive Index Calibration X X
Precision / Accuracy (Repreps, Recounts,
etc.)
X
Equipment Alignment X
Equipment Maintenance X
Laboratory Blank X
Round Robin 2X
NVLAP Proficiency Testing 2X
Multiple Preparations X
Air Monitoring X X
Tape Sampling X X

ORGANICS LABORATORY & PERSONNEL
Action Performed Batch Daily Quarterly Yearly As Required
Equipment and Supplies Contamination
Check
X
Quality Control Samples (Precision /
Accuracy)
X
Equipment Calibration X
Equipment Maintenance X
Initial Demonstration of Capability X
Contamination Monitoring (Wipe) 4X
Laboratory Preparation Blank X
Method Detection Limits X X
Proficiency Analytical Testing Samples 2X

MICROBIOLOGY LABORATORY & PERSONNEL
Action Performed 1% 10% Daily Monthly Quarterly Yearly As
Required
Equipment and Supplies Contamination
Check
X X
Precision / Accuracy (Recounts / Counting
Standard, etc.)
X X
Equipment Alignment & Calibration X X X
Equipment Maintenance X X
Method Blank X
Round Robin 2 X
Counting Standards (1 of 20 samples) X
Air Monitoring X X
Proficiency Analytical Testing Samples X X

5.0 TYPES OF ANALYSES (SUMMARIZED)
5.1 Air Sample Analysis by Transmission Electron Microscopy (TEM)
Mixed cellulose ester (MCE) and polycarbonate (PC) air filters submitted for TEM analysis are
prepared according to the Interim Transmission Electron Microscopy Analytical Methods contained
within AHERA (40 CFR Part 763 Appendix A, Subpart E). Asbestos fibers are identified by their
morphologies, elemental compositions through energy dispersive X-ray spectrometry (EDX), and
characteristic diffraction patterns by selected area electron diffraction (SAED). Samples are counted
for asbestos structures (i.e., fibers, bundles, clusters, and matrices) according to the rules defined in
the AHERA regulations. Analytical results are discussed in a report and are presented in tabular
format. The reported data includes the number of asbestos structures, number of asbestos fibers
greater than 5 microns in length, asbestos fiber concentration on the filter (structures/mm) and in the
air volume sampled (structures/cc). The report is further documented with analytical count sheets.
Transmission Electron Microscopy (TEM) methods for analysis of air samples according to ISO
10312, EPA Level II (Yamate, et.al., 1984) and NIOSH 7402 are also available as per client request,
for projects not subject to the AHERA regulations. The samples are prepared and analyzed in
accordance with the EPA/NIOSH approved method requested. The laboratory maintains NVLAP
(NVLAP Lab Code 101896-0) accreditation.
5.2 Air Sample Analysis by Phase Contrast Microscopy (PCM)
Mixed cellulose ester air filters submitted for PCM analysis are prepared according to the NIOSH
7400 method. The client specifies NIOSH 7400 A (Issue 2), B rules or OSHA Reference Method
counting rules. Analyses are carried out utilizing the Phase Contrast Microscope fitted with a
Walton-Beckett Graticule calibrated to 100um field of view. Optically observable fibers meeting
length and aspect ratio criteria are counted.
Fiber concentrations are quantified and analytical results are reported in tabular format. The reported
data includes Fiber Concentration (F/cc), Detection Limit (F/cc), Fiber Density (F/mm2), Fiber Count,
Fields Analyzed, Volume and other pertinent data. The data is documented with analytical count
sheets. The laboratory maintains AIHA-LAP (AIHA LAP 101533) Accreditation.
5.3 Bulk Sample Analyses by Transmission Electron Microscopy (TEM)
Reservoirs offers three methods of bulk sample analysis: Quantitative, Semi-Quantitative, and
Presence/Absence.
5.3.1 Quantitative Bulk Sample Analysis
Each bulk sample submitted for quantitative TEM analysis is ground into a homogeneous
powder, weighed and suspended in filtered distilled water. An aliquot is deposited onto a
polycarbonate or mixed cellulose ester filter.
The filter is then prepared and analyzed by TEM/EDX/SAED per Level II TEM protocol. Asbestos
structures and dimensions are recorded on the analytical count sheets. The mass of each
asbestos type present is calculated based on the fiber dimensions and density of the asbestos
structures counted, and is reported in weight percent.

5.3.2 Semi Quantitative Bulk Sample Analysis
A representative sub-sample of the bulk material (most commonly floor tile) is weighed and then
placed in a muffle furnace to burn away all organic material. The residue is ground in a mortar
and pestle and treated with acid to remove carbonate materials. The material that remains after
the acid treatment is suspended in water and deposited onto a pre-weighed polycarbonate filter.
The filter is then dried in a dessicator and weighed again. A sample of the deposit is analyzed by
TEM and an estimate of the percent asbestos present relative to the total amount of debris is
recorded. The estimated percent asbestos related to residue and the original weight of the sub-
sample yields a semi-quantitative weight percent of asbestos in the sample, as well as estimated
percentages of organic and carbonates matrix materials.
 5.3.3 Asbestos Presence/Absence Bulk Sample Analysis
A representative sub-sample of the bulk material is pulverized and treated with solvents in an
ultrasonic bath to liberate fibers contained in the sample matrix. An aliquot of the resulting
suspension is deposited on a carbon coated TEM grid. The grid is examined in the TEM to
determine the presence/absence of asbestos minerals. Identification of fibers present is
confirmed by SAED/EDX.
5.4 Bulk Sample Analysis by Polarized Light Microscopy (PLM)
Each bulk sample submitted for PLM analysis is prepared and analyzed following guidelines outlined
by the EPA 600/R-93/116, 1982 & 1993.
Reservoirs also offers analytical procedures to comply with EPA 40 CFR, Part 61, NESHAP Final
Rule (FR 40710), November 10, 1990.
Each sample preparation is analyzed using a polarized light microscope fitted with a dispersion-
staining objective. Positive identification of each layer's constituents is performed through observation
of optical properties such as color, pleochroism, extinction angle, birefringence, sign of elongation,
dispersion staining colors and other distinguishing optical characteristics. A report is generated
identifying and quantifying each layer and its asbestos and non-asbestos components in estimated
volume/area percents.
5.5 Water Sample Analyses by Transmission Electron Microscopy
TEM Level II, EPA 100.1 or EPA 100.2 protocol is used for water samples submitted for TEM
asbestos analysis. An aliquot of the sample is deposited on a polycarbonate or mixed cellulose ester
filter. The filter is dried and prepared for TEM analysis. Analytical results are discussed in a letter
report and presented in a tabular format, which includes the aliquot deposited, number of asbestos
structures, number of asbestos structures greater than 10 microns in length, filter area analyzed, and
asbestos concentration (structures/Liter).
5.6 Heavy Metal Analyses in Air, Paint, Soil Bulk, Wipe, and Water by Inductively
Coupled Plasma (ICP), Flame Atomic Absorption (FAA), Graphite Furnace
Analysis (GFAA), Cold Vapor Analysis (CV), and Gravimetric Analysis.
Samples submitted are processed via an appropriate temperature and acid digestion method, and
diluted to volume prior to analysis. The sample is digested is then analyzed by ICP, Atomic
Absorption Spectroscopy (FAA, GFAA, or CV), or Gravimetric analysis.
Methods used are outlined by EPA, NIOSH, or OSHA depending on the matrix, analyte, and
detection levels required by the client. Analytical results determine a concentration of the analyte per
solution. This is reported to give a concentration of the analyte per area, volume, or mass. Materials
submitted of TCLP require an 18 hour leaching period prior to analysis.

5.7 Water/Soil/Waste Sample Analysis by Gas Chromatography.
Upon receipt by the laboratory, samples are cooled to <4C in the sample refrigerator. The sample is
transferred, if necessary, to a 40 mL Volatile Organics Analysis tube in a manner to minimize the loss
of volatile compounds. During preparation, the Varian Archon autosampler places the vial in a 40C
heating coil and pierces an injection needle through the vial septum. An internal standard and
surrogate standard solution is added through the needle. The sample is then purged with a flow of
nitrogen gas. Volatile organic compounds are forced into the headspace and through a transfer line to
an absorbent trap, consisting of Tenax, silica gel, and activated charcoal. After sufficient purge time,
the trap is flash-heated and backflushed to inject the sample into the gas chromatograph.
Compounds are detected based on retention time and mass spectrum.

5.8 Pathogenic Bacteria Sample Analysis
An increasing number of production companies must establish and maintain effective sampling and
testing protocols for selected pathogenic bacteria. Using the latest methodologies, our highly skilled
microbiologists can analyze environmental samples for a multitude of pathogenic organisms, fungal
contaminants and product sterility.

5.9 Spoilage and Indicator Bacteria Analysis
Using only the industries’ most widely accepted analytical methods, we offer spoilage and indicator
organism identification services. Reservoirs can perform bacterial analysis of environmental samples
for E.coli, Staphylococcus aureus, Coliforms, Yeast: Mold, and Aerobic Plate Count.

*Please refer to our fee schedule for a complete list of services offered*

6.0 INSTRUMENTATION
Asbestos
Reservoirs uses two in-house JEOL electron microscopes: JEM 100CX II STEM with IXRF EDX system
and JEM 1200EX with EDAX system. These instruments are capable of performing selected area
electron diffraction (SAED). Both STEMs are capable of resolving individual asbestos fibers less than 0.1
micron in diameter. Microscopes are calibrated and adjusted to maintain paramaters set by the Quality
Assurance/Quality Control program; Magnification, spot size, grid opening area, EDX, SAED are all a part
of this program.
The PCM air samples are analyzed using either of our two Olympus CX31 phase contrast microscope
fitted with Walton-Beckett graticules. PLM samples are analyzed using Zeiss, Wild or Meiji stereo-
binocular microscopes and Zeiss, Olympus or Nikon polarized light microscopes fitted with dispersion
staining objectives.
Reservoirs has a complete sample preparation laboratory for air and water samples, and a separate
facility for bulk sample preparation. The preparation laboratories contain all required equipment including:
laminar flow hoods, fume hoods, plasma asher, and carbon evaporation units.
Metals
The metals laboratory utilizes Inductively Coupled Plasma Mass Spectrometry technology for the
determination of metals in various matrices. The Perkin Elmer NexION 300X instrument is a mass
spectrometer capable of simultaneously analyzing multiple elements.
The metals preparation laboratory is fully equipped for the proper digestion of all sample matrices
including the appropriate; glassware, fume hoods, balances, etc. Microsoft Access based computer
system is used for data reduction and reporting.
Organics
The organics laboratory has two Hewlett Packard Series II 5890 GC/FID analytical systems. Both
systems are equipped with a flame-ionization detector and a Hewlett Packard 5971 Mass Selective
Detector. Volatile organic compounds are analyzed with the GC/MS coupled to a Varian Archon purge
and trap autosampler and an O.I. Analytical 4560 concentrator. Methamphetamine extracts are analyzed
using a GC/MS equipped with a Hewlett Packard 7673A Liquid autosampler.
Microbiology
The microbiology lab analyzes microbial samples using a Leitz Diaplan, Leitz Orthoplan or Olympus
CH30 light microscope. The microbiology lab is also equipped with a Biological Class II Safety Cabinet,
Forma Scientific - Model 1112 for sample preparation.
The microbiology lab is fully equipped for the proper handling, preparation and propagation of biological
organisms including appropriate incubators, balances, media, autoclaves, etc. Microsoft Excel based system is
used for data reporting.

7.0 PERSONNEL QUALIFICATIONS
Jeanne Spencer CEO/President
Laboratory Director
Ms. Spencer is the President and CEO of Reservoirs Environmental LLC. A founding member of
Reservoirs Environmental, she directly oversees day to day operations. Ms. Spencer is also actively
involved in the industry both locally and nationally. She acts as an expert witness/advisor as needed by
clients. Jeanne is a technical expert, providing both analytical services and method development for the
Libby, Montana Project. Over the years, she has acted as a lab consultant in Paris, France. Participated
in the development CO Reg. 8, Lead Regulations for the State, and participated in the ASTM committee
developing standards for the industry.
Ms. Spencer received her B.S. Degree in Microbiology at Ohio State University. Prior to working at
Reservoirs, she worked at Battelle Memorial Institute for eight years where she was directly involved in
the research and development of analytical procedures adopted by the US EPA. Jeanne joined
Reservoirs in 1987 as the laboratory director, where she led the transformation of Reservoirs
Environmental, Inc. “Geology” to “Environmental”. With her direction the laboratory gained its NVLAP and
AIHA-LAP accreditations for Air/Bulk asbestos, metals and microbiological analyses, and began providing
analytical services to the industry.
Training and Certificates:
TEM Planner
EPA NIOSH 582
AHERA Building Inspector

Robin S. Klover
CFO, Vice President
AIHA LAP Laboratory Operations Manager
AIHA LAP Quality Assurance Manager
PCM/Metals Analyst
Mr. Klover received his B.S. Degree at Kansas State University in Science and has completed two years
in their master’s program. Robin has been with Reservoirs Environmental, Inc. since January 1994. As
Laboratory Manager Robin schedules staff and directs laboratory production. As the Quality
Control/Quality Assurance Manager for the laboratory, he maintains compliance with AIHA LAP
accreditations. Robin is the technical manager for the Metals, Chemistry and Phase Contrast Microscopy
Laboratories.
Training and Certificates:
EPA NIOSH 582
Radiation Safety Officer Training

Paul LoScalzo
NVLAP Laboratory Operations Manager
Radiation Safety Officer
TEM/PLM/PCM/SEM Analyst
Mr. LoScalzo received his B.A. Degree in Geology from the University of Colorado. Paul has been with
Reservoirs Environmental, Inc. since 1992. As Laboratory Manager, Paul schedules staff and directs
laboratory production. As the Quality Control/Quality Assurance Coordinator, he maintains compliance of
NVLAP Accreditations, which includes regulatory compliance under Reservoirs' Radioactive Materials
License. Paul is the technical coordinator for the Polarized Light Microscopy and Transmission Electron
Microscopy Laboratories.
Training and Certificates:
EPA NIOSH 582
McCrone - Microscopical Identification of Asbestos
OSHA Hazwoper (40 HR)
EPA Certified Asbestos Inspector
Radiation Worker
Optical Mineralogy
Radiation Safety Officer Training

Brett Colbert - PLM Analyst
Mr. Colbert joined Reservoirs in 1994 and worked in Colorado until 2000. He transferred to Texas and
started his own asbestos laboratory when Reservoirs was sold. Brett rejoined Reservoirs in 2012 and is
responsible for PLM analysis.
Training and Certificates:
EPA NIOSH 582E
McCrone - Microscopical Identification of Asbestos
Daniel Erhard - PLM Analyst
Mr. Erhard received his B.S. in Marine Geology from Eckerd College. Mr. Erhard joined Reservoirs in 2016
and is responsible for PLM analysis.
Gregory Hronich - PLM Analyst
Mr. Hronich received his B.S. in Environmental Health from the Colorado State University. Mr. Hronich joined
Reservoirs in 2017 and is responsible for PLM Analysis.
Ryan Schilling - PLM Analyst
Mr. Shilling received his B.S. in Geological and Atmospheric Sciences from Iowa State University. Mr.
Shilling joined Reservoirs in 2017 and is responsible for PLM Analysis.
Josh Baker - PLM Analyst
Mr. Baker received his B.S. in Geology from Western State College of Colorado. Mr. Baker joined Reservoirs
in 2017 and is responsible for PLM Analysis.
Tyler Hutchinson - PLM Analyst
Mr. Hutchinson received his B.S. in Geological Sciences from Ohio University. He joined Reservoirs in 2018
and is responsible for PLM analysis.
Thomas Harbour - PLM Analyst
Mr. Harbour received his M.S. in Geology from Iowa State University. He joined Reservoirs in 2019 and is
responsible for PLM analysis.

John McIntyre - PLM Analyst
Mr. McIntyre received his B.S. in Geology from University of Colorado. He joined Reservoirs in 2018 and is
responsible for PLM analysis.
Andrew Roberts - PLM Analyst
Mr. Roberts received his B.S. in Geological Engineering from Colorado School of Mines. He joined
Reservoirs in 2018 and is responsible for PLM analysis.
Emily Giddens - PLM Analyst
Ms. Giddens received her B.S. in Geological Engineering from Colorado School of Mines. She joined
Reservoirs in 2019 and is responsible for PLM analysis.
Piper-Lenore Murphy - PLM Analyst
Ms. Murphy received her B.S. in GeoSciences – Earth Systems from University of Arizona. She joined
Reservoirs in 2018 and is responsible for PLM analysis.
William Spells - PLM Analyst
Mr. Spells received his B.S. in Geology from Western State Colorado University. He joined Reservoirs in
2018 and is responsible for PLM analysis.
Norberto Zimbelman - TEM Analyst / PCM Analyst / Chemistry Technician
Mr. Zimbelman attended FAE University in Sao Paulo, Brazil and joined Reservoirs in 1999. Norbie has
extensive experience in the analysis of superfund samples by TEM. He is responsible for PCM/TEM/Metals
sample preparation and analysis.

Training and Certificates:
EPA NIOSH 582E
Matthew Barr - TEM Analyst / PCM Analyst
Mr. Barr received his B.A. in Geology from Middlebury College. He joined Reservoirs in 2019 and is
responsible for TEM/PCM sample preparation and analysis.
Training and Certificates:
EPA NIOSH 582E
Patricia Wood - TEM Analyst / PCM Analyst
Ms. Wood received her B.S. in Geology from SUNY at Stony Brook. She joined Reservoirs in 2018 and is
responsible for TEM/PCM sample preparation and analysis.
Training and Certificates:
EPA NIOSH 582E
Sean Kieffer - PCM Analyst / TEM Prep / Metals Prep
Mr. Kieffer received his B.S. in Biology from University of Mary. He joined Reservoirs in 2019 and is
responsible for PCM analysis as well as TEM & Metals preparation.
Training and Certificates:
EPA NIOSH 582E
Evan Alger-Meyer - PCM Analyst / TEM Prep / PLM Analyst
Ms. Alger-Meyer received her B.S. in Geology from Washington University. She joined Reservoirs in 2019
and is responsible for PCM and PLM analysis as well as TEM preparation.
Training and Certificates:
EPA NIOSH 582E

Alejandro Mejia - PCM Analyst / TEM Prep
Mr. Mejia is currently pursuing B.S. degrees in Biology and Computer Science from the University of
Colorado, Denver. He joined Reservoirs in 2017 and is responsible for PCM analysis as well as TEM
preparation.
Training and Certificates:
EPA NIOSH 582E
Ryan Ellerby – Metals/Organics Analyst / PCM Analyst
Mr. Ellerby has a B.A. in Chemistry from Hampshire University. Mr. Green joined Reservoirs in 2019 and is
responsible for Metals/Organics analysis as well as PCM analysis.

Training and Certificates:
EPA NIOSH 582E
Jeff Green - Metals/Organics Analyst / PCM Analyst / TEM Analyst
Mr. Green has a B.S. in Chemistry from Cleveland State University. Mr. Green joined Reservoirs in 2017 and
is responsible for Metals/Organics analysis, PCM analysis as well as TEM preparation and analysis.
Training and Certificates:
EPA NIOSH 582E
David Spero - Microbiology Lead Analyst
Mr. Spero received his B.A. in Biology from Sonoma State University. Prior to joining Reservoirs in 2020, Mr.
Spero worked in consulting and laboratory management for the last 20 years. He has extensive experience
in environmental microbiology. Mr. Spero is responsible for overseeing the microbiology laboratory and
associated quality assurance program.
Sam Li - Microbiology Analyst
Mr. Li received his B.A. in Geology from the University of Colorado Boulder. Mr. Li joined Reservoirs in
2019 and is responsible for microbiology analysis.

Training and Certificates:
EPA NIOSH 582E
AnneMarie Kieffer - Customer Support / Administrative Assistant 
Ms. Kieffer has a B.S. in Marketing and Communications from the University of Mary. Ms. Kieffer joined
Reservoirs in 2019 and is responsible for a variety of administrative duties, including project log-in, customer
support, bookkeeping entry and project data reporting.
Hanna Marti - Customer Support  
Ms. Marti has a B.S. in University Studies from Northern Arizona University. Ms. Marti joined Reservoirs in
2019 is responsible for a variety of administrative duties, including project log-in and customer support.

8.0 ACCREDITATION AND LICENSES
8.1 NVLAP LAB Code 101896-0 Accreditation for TEM and Bulk
Reservoirs received National Voluntary Laboratory Accreditation Program (NVLAP Lab Code 101896-0 )
accreditation for airborne asbestos fiber analysis (TEM) and bulk (PLM) on July 24, 1990.
8.2 AIHA LAP 101533 Accreditation for Phase Contrast Microscopy
Reservoirs is accredited through the American Industrial Hygiene Association Laboratory Accreditation
Program for asbestos air sample analysis by phase contrast microscopy. Reservoirs participates in the
AIHA LAP PAT (AIHA LAP 101533) program for PCM analysis.
8.3 AIHA LAP-IHLAP 101533 Accreditation for Metals
Reservoirs is accredited through the American Industrial Hygiene Association Laboratory Accreditation
Program for the analysis of air samples for metal content. Reservoirs participates in the AIHA-LAP
PAT (AIHA LAP 101533) program for metal analysis.
8.4 AIHA LAP-ELLAP 101533 Accreditation for Lead Analysis
Reservoirs is AIHA LAP (AIHA LAP 101533) accredited for the analysis of lead in environmental; paint,
soil and dust wipe samples through the ELPAT (ELLAP) Program.

8.5 AIHA LAP 101533 Food Laboratory Accreditation Program (FoodLAP)
Reservoirs is AIHA LAP (AIHA LAP 101533) accredited for bacterial analysis of food. Reservoirs
participates in the Association of Analytical Communities’ (AOAC) and American Proficiency Institute’s
microbiology proficiency programs.
8.6 State of Colorado Department of Public Health and Environment
Reservoirs is accredited for drinking water analysis of total coliforms & E.coli through the State of
Colorado.

9.0 Representative Project Experience
ꞏ Aurora Public Schools - Aurora, CO
ꞏ Dallas Independent School District - Dallas, TX
ꞏ Denver Housing Authority - Denver, CO
ꞏ Denver Public Schools - Denver, CO
. Department of Defense Dependent Schools (Germany)
ꞏ Kaiser-Hill - Rocky Flats - Golden, CO
ꞏ Federal Aviation Administration - Worldwide Projects
ꞏ Federal Bureau of Prisons - Littleton, CO
ꞏ San Antonio Independent School District - San Antonio, TX
ꞏ US EPA – Libby Montana
ꞏ U.S. Courts - Denver, CO
ꞏ U.S. West - Denver, CO
ꞏ U.S. State Department – Worldwide
ꞏ City and County of Denver - DAT

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11.0 CERTIFICATIONS

R & R Environmental, Inc.
47 West 9000 South, Suite #2, Sandy, Utah 84070 [phone]: Office  [phone]: Fax
www.rrenviro.com

May 23, 2023

Mr. Thomas Daniels
Site Assessment Section Manager
State of Utah, Department of Environmental Quality
Division of Environmental Response and Remediation
195 North 1950 West
Salt Lake City, Utah 84114-42894
Sent via email: [e-mail]

RE: Regulator Agency Comments and Responses – Final
Treasure Mountain Junior High School Soils Sampling and Analysis Plan (SAP)
1048 Oakridge Drive
Centerville, Utah 84014

Mr. Daniels:

R & R Environmental, Inc. (R & R) is pleased to provide this information related to the comments
indicated in the letter from the Utah Department of Environmental Quality, Division of Environmental
Response and Remediation, dated March 9, 2023. Please note the following:

Comment 1 Indicates:
“The December 9, 2022 letter specifies that the characterization of the soil stockpiles include:
• Total Metals and TCLP analysis of the soil piles.
• The volume of the soil piles.
• Verification of the thickness and composition of cap material to ensure a minimum of six inches
of soil containing 200 mg/kg lead or less.

While lead and arsenic are the primary contaminants of concern at the site as reflected in the table in
section 2.1.3, DEQ would like to see total metals analysis for all samples as
indicated in the letter. Additionally, a discussion of TCLP analysis does not appear to be present. Please
add TCLP analysis to the sampling and analysis plan.

Please also provide additional narrative details regarding soil pile volume assessment, and include
additional samples that will provide a verification of the thickness and composition of the cap material to
ensure that there is a minimum of six inches of soil present that contains 200 mg/kg of lead or less.

Please include that a copy of the Asbestos Inspection Report will be submitted to Rachel Hancock,
Division of Air Quality as well as to DERR.”

Comment 1 Original Response:
3. Section 4.6 Soil Cap – The following section was added to the SAP and the sample table was updated
to include the lead samples. “The thickness of the soil cap on the soils pile will be determined at a
minimum of four (4) locations on the surface of the soils pile. The soils pile will be figuratively divided
into four approximately equal sections and at least one thickness measurement will be made within the
area of each section. Approximate locations of each measurement will be determined with a hand-held
GPS device and recorded. Thickness of the soil cap will be measured by using hand tools to remove a
small (less than 2 square feet) area of the cap soils until the underlying soils (tailings) are encountered.

2 | Page

Upon encountering the tailings, the thickness of the cap soil at the location will be measured and
recorded. The disturbed cap soil will then be replaced with hand tools.

The soil cap will be sampled by the Soil Sampler during the soil cap thickness testing. The Soil Sampler
will collect four (4) soil cap samples at the same locations as the thickness testing. Each of the four (4)
samples collected will be analyzed by Chemtech-Ford Laboratories for Total Lead to verify the soil cap
contains 200 mg/kg lead or less.”

Comment 1 Response to R&R Comments:
3. Non-concur. At least one cap assessment is needed from the C&D pile as well.

Comment 1 Current Response:
3. Section 4.6 Soil Cap – The sentence was added to the end of the section. “One cap assessment
sampling location will also occur on the C&D pile using the same protocols as indicated above.”

Comment 3 Indicates:
“Please provide in the text an estimated number of samples to be collected broken down by per pile - i.e.
estimated 6 composite samples from the soil pile, and estimated 3 composite samples from the waste pile.

Comment 3 Original Response:
Section 2.2 Sample Summary – Section 2.2 was added to the SAP. The previous Section 2.2 has been
changed to Section 2.3. Section 2.2 now indicates, “Twelve (12) composite TCLP and twelve (12)
composite Total Metals samples will be obtained from the soils pile. Two (2) composite TCLP and two
(2) composite Total Metals sample will be obtained from the C&D pile. Four (4) grab samples will be
obtained from the soil cap on the soil pile. Asbestos samples will be obtained as necessary from the C&D
Pile as determined by the inspector. The R&R Project Manager reserves the right to add samples and
analytical methods during the sampling process if it is deemed warranted by the discretion of the Project
Manager.”

Comment 3 Response to R&R Comments:
Non-concur: The Sample Summary Table shows only one sample collected from the C&D Pile, S-13, the
text states "Two (2) composite TCLP and two (2) composite Total Metals Samples will be obtained from
the C&D Pile". Please clarify which number of samples is correct.

Comment 3 Current Response:
Section 2.2 Sample Summary – The paragraph was modified to read as follows. “Twelve (12) composite
TCLP and twelve (12) composite Total Metals samples will be obtained from the soils pile. Two (2)
composite TCLP and two (2) composite Total Metals samples will be obtained from the C&D pile. Four
(4) grab samples will be obtained from the soil cap on the soil pile and one (1) grab sample will be
obtained from the soil cap on the C&D pile. Asbestos samples will be obtained as necessary from the
C&D Pile as determined by the inspector. The R&R Project Manager reserves the right to add samples
and analytical methods during the sampling process if it is deemed warranted by the discretion of the
Project Manager. An estimated twelve (12) soil samples will be obtained from the soils pile and an
estimated two (2) soil (material) samples will be obtained from the C&D pile.”

Comment 5 Indicates:
“Please add a composite sample from the C&D pile collected approximately 2' from the bottom of the
pile.”

3 | Page

Comment 5 Original Response:
A composite sample from the C&D pile collected approximately 2; from the bottom of the pile is already
indicated in the Sample Summary Table. No changes were made to the SAP.

Comment 5 Response to R&R Comments:
Non-concur. DERR made a mistake in this comment, we would like to see at least two composite samples
(top and bottom), and preferably three (top, middle, bottom), collected from the C&D pile. The comment
was meant to read "Please add a composite sample from the C&D pile collected approximately 2' from
the top of the pile".

Comment 5 Current Response:
Section 2.2 Sample Summary – The sample summary table and the map were updated to reflect the
changes and the paragraph was modified to read as follows. “Twelve (12) composite TCLP and twelve
(12) composite Total Metals samples will be obtained from the soils pile. Two (2) composite TCLP and
two (2) composite Total Metals samples will be obtained from the C&D pile. Four (4) grab samples will
be obtained from the soil cap on the soil pile and one (1) grab sample will be obtained from the soil cap
on the C&D pile. Asbestos samples will be obtained as necessary from the C&D Pile as determined by
the inspector. The R&R Project Manager reserves the right to add samples and analytical methods during
the sampling process if it is deemed warranted by the discretion of the Project Manager. An estimated
twelve (12) soil samples will be obtained from the soils pile and an estimated two (2) soil (material)
samples will be obtained from the C&D pile.”

Comment 12 Indicates:
“Please provide details relating to how the sample location will be recorded.”

Comment 12 Original Response:
Section 4.2 Samples for RCRA Metals in Soil – The following sentences were added to Section 4.2/3.
“Sample numbers to be used are indicated in the Sample Summary Table. The Soil Sampler will record
the sample number from the Sample Summary Table onto the laboratory container for each sample. The
sample number and location will be confirmed against the map in Appendix A and the sample number
will be recorded in a field notebook.”

Comment 12 Response to R&R Comments:
Non-concur. What GPS system will be used to note sample locations? Please also provide the GPS
accuracy (ie. within 1m).

Comment 12 Current Response:
Section 4.2 Samples for RCRA Metals in Soil – The following sentence was modified as indicated below.
“For each sample, the Soil Sampler will record the sample number and PID reading in the logbook and
the sample location in the pile will be surveyed in using a Trimble R8 GPS (or similar) to determine State
Plane Coordinates with an accuracy of less than 1 meter.”

Section 4.3 Samples for Asbestos in Construction Debris – The following sentences were added to end of
Section 4.3, “For each arsenic and lead sample in the C&D pile, the Soil Sampler will record the sample
number reading in the logbook and the sample location in the pile will be surveyed in using a Trimble R8
GPS (or similar) to determine State Plane Coordinates with an accuracy of less than 1 meter. Asbestos
samples will not be surveyed. The pile will be classified using AHERA protocols related to the
homogeneous nature of the materials identified by the Asbestos Inspector.”

4 | Page

Comment 16 Indicates:
“Please provide in the report details on how the cap will be replaced/repaired following sampling
activities.”

Comment 16 Response:
Section 4.3 Soil Cap Replacement – The following paragraph was added to the SAP

“4.8 Soil Cap Replacement

To facilitate sampling, the track hoe (or similar) bucket will be inserted through the cap and into the piles.
Soil will be removed and placed on polyethylene sheeting until the bucket with the sample is removed.
After the sampling has been completed, the removed soil will be placed back into the vertical testing pits.
Clay will be imported to the site and placed over the sample holes to match the thickness of the existing
cap. If the thickness of the existing cap is determined to be less than adequate, the cap thickness will be
addressed in the future Soils Management Plan. Following replacement of the cap, the straw cover will
also be replaced.”

Comment 17 Indicates:
“Please update the sample location map to reflect the new sample numbers as shown in the Sample
Summary Table”

Comment 17 Response:
The Sample Location Map was updated to match the Sample Summary Table.

Note: Section 4.2, 5th Paragraph - Modified as Indicated Below:
“The residual dirt on the track hoe bucket, from sampling, will be brushed clean at each new vertical
sampling location and samples will be obtained from the approximate center of the bucket.”

The reason this was changed is: the bucket must pass through the upper levels of the piles to reach the
lower levels of the piles. Therefore, the bucket will pass through the above space that was previously
sampled and cleaning the bucket to pass through the space above will not prevent cross-contamination if
the piles are not homogeneous in nature.

5 | Page

Thank you for the opportunity to provide these services. Please feel free to contact me at
[e-mail] or 801-971-3988 if there are any questions or if additional information is required.

Sincerely,

R & R ENVIRONMENTAL, INC.

Stephen S. Galley, CSP
Environmental Division Director

Encl: R & R Environmental Inc., Treasure Mountain Junior High Soils Sampling and Analysis Plan,
dated January 20, 2023, revised April 5, 2023.

c: Ryan Blair, Park City Zoning
Kerry Guy, U.S. Environmental Protection Agency, Region 8
Rachel Hancock, Division of Air Quality
Todd Hansen, Park City School District
Wade Hess, Division of Waste Management and Remediation Control
Hannah Marty, Division of Environmental Response and Remediation
Marty McComb, U.S. Environmental Protection Agency, Region 8
Dave Roskelley, R & R Environmental, Inc.
Brian Speer, Division of Waste Management and Remediation Control

R & R Environmental, Inc.
APPENDIX D

RECORD OF CHANGES
(Not Presently Used)