600R81101
GUIDELINES AND SPECIFICATIONS FOR IMPLEMENTING
QUALITY ASSURANCE REQUIREMENTS
FOR DEMONSTRATION PROJECTS FINANCIAL ASSISTANCE
INVOLVING ENVIRONMENTAL MEASUREMENTS
QAMS-003/80/02
Quality Assurance Management Staff
Office of Monitoring Systems- and Quality Assurance
Office of Research and Development
U.S. Environmental Protection Agency
August 3, 1981
U.S. CfiVlr • " :->a Agency
ftoglon '
230 80s.:.
Chicago, n,.»\ -jiV«
DRAFT
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Guidelines and Specifications for Implementing
Quality Assurance Requirements
for Demonstration Projects Financial Assistance
Involving Environmental Measurements
Abstract
On May 30, 1979, an EPA policy was established requiring all Regional
Offices, Program Offices, EPA Laboratories, and the States to participate
in a centrally-managed Agency-wide Quality Assurance (QA) Program. The
stated goal of the program is to ensure that all environmentally-related
measurements which are funded by EPA or which generate data mandated by
EPA are scientifically valid, defensible, and of known precision and
accuracy. A memorandum dated June 14, 1979 extended these QA require-
ments to all EPA extramural projects, including contracts, interagency
agreements, and grants and cooperative agreements that involve environ-
mental measurements.
This document aids Project Officers, QA Officers, and Program
Managers Involved in the administration of demonstration projects (grants
and cooperative agreements) to uniformly Implement the Administrator's QA
Policy. The Intent of this document is to ensure that QA requirements
for these extramural projects are consistent and appropriate to meet
EPA*s data quality objectives.
Guidance and review forms are provided to assist in the systematic
review of QA requirements for environmental measurement projects assisted
by EPA. The steps of the review include: (1) requirements of the
application; (2) evaluation of the application; and (3) requirements of
the agreement.
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Applicants for assistance should stipulate their willingness to
participate in appropriate EPA QA performance audits as part of the
evaluation process or during the assistance period. Each applicant
will be required to submit a QA program plan to EPA for approval and
agree to prepare a QA project plan(s) prior to award of financial assis-
tance. The QA program plan will become a part of the agreement incorpo-
rated by reference. The agreement must also include requirements for
submitting separate periodic QA reports, EPA's right -to conduct en-site
QA systems audits, and as appropriate, requirements for participation
in EPA performance evaluation (PE) studies.
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Revision No. I
Date: 8-3-81
Page 1 of 10
Guidelines and Specifications for Implementing
Quality Assurance Requirements
For Demonstration Projects Financial Assistance
Involving Environmental Measurements
1.0 INTRODUCTION
By memoranda of May 30, 1979 and June 14, 1979 EPA established
policy requiring participation in a Quality Assurance (QA) Program by
all organizations conducting environmental measurements required or sup-
ported by the EPA. The aim of this policy is to ensure that all environ-
mentally related measurements funded or mandated by the EPA are scienti-
fically valid, defensible, and of adequate and known precision and
accuracy.
1.1 Purpose
The purpose of this document is to assist EPA Project Officers, QA
Officers, and Program Managers in the uniform implementation of QA
requirements for environmental measurements supported via Federal Assis-
tance for Demonstration Projects. This document does not invalidate
&ny QA requirements stipulated in current EPA regulations.
1.2 Authority
The Office of Research and Development is delegated the responsi-
bility to develop and direct the implementation of -the National QA Program
for the Agency (Delegation of Authority Manual, Chapter 1_, March 4,
1981).
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1.3 Applicability and Scope
This document applies to all financial assistance for Demonstration
Projects involving environmentally related measurements. This includes
all demonstration assistance agreements designated as Grants or Coopera-
tive Agreements under the Federal Grant and Cooperative Agreement Act,
40 CFR Part 30.
1.4 Definitions
.1 Applicant - any individual, agency, or entity which has filed a
preapplication or an application for Federal Assistance pursuant
to the Federal Grant and Cooperative Agreement Act.
•2 Assistance — an award of funds or other aid via a written
assistance agreement,
.3 Assistance Agreement - the written agreement (grant or coopera-
tive agreement) and amendments thereto between EPA and a recipi-
ent in which the terms and conditions governing the assistance
are stated and agreed to by both parties pursuant to 40 CFR
Part 30, revised as of_June 30, 1978.
.4 Assistance Approving Official — the EPA official designated
to approve assistance and take other assistance-related actions
authorized by Environmental Protection Agency Orders or 40 CFR
Part 30 (Sometime referred to as the Decision Official).
.5 Demonstration Project - vode of assistance for demonstrating the
practical application of a new device, technique, or control
technology to a process or measurement.
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.6 Environmental Measurement - all field or laboratory investiga-
tions which generate data such as measuring the chemical, physi-
cal, or biological parameters in the environment; determining
pollutants in waste streams; conducting health and ecological
effect studies; carrying out clinical and epidemiological inves-
tigations; performing engineering and process evaluations; con-
ducting studies involving simulation of environmental events;
investigating"pollutant transport and fate; and developing and
using models.
.7 Federal Assistance - the entire Federal contribution for a
project including, but not limited to, the EPA Assistance amount.
.8 Performance Evaluation - documentation of laboratory's ability
to consistently produce valid data of known and acceptable
quality. This is done through analysis of samples of -known and
certified concentration.
.9 Project - the undertaking identified in the assistance agreement
which will receive EPA assistance for a specified budget period;
may refer to a program (e.g., State water pollution control
program, air pollution control program).
.10 Project Officer - the EPA official designated in the assistance
agreement as the Agency's principal contact with the recipient
of funds for a particular project; this person Is responsible
for monitoring the performance and coordinating the project.
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.11 Project Period - the period of time specified in the assistance
agreement estimated to be required for completion of the project
for which Federal assistance has been requested; it is composed
of one or more budget periods.
.12 quality Assurance - the total integrated program for assuring
the reliability of monitoring and measurement data.
.13 Quality Assurance Officer - that individual who is assigned the
responsibility for QA overview and guidance of QA for an organi-
zation or for a specific project; the QA officer must be in a
position to provide independent and objective evaluations and
assessments of the effectiveness of the QA program, and to pro-
vide timely feedback recommendations and approvals.
.14 Quality Assurance Program Plan - a written document prepared by
applicant/recipient which presents, in general terms, the over-
all policies, organization, objectives, functional responsi-
bilities (within the organization), and general procedures
designed to achieve data quality goals.
.15 Quality Assurance Project Plan - a written document prepared by
applicant/recipient for a specified project which details the
policies, organization, objectives, functional activities, and
specific QA and quality control (QC) procedures and activities
designed to achieve data quality goals or requirements. The QA
project plan includes specific procedures to be used to routinely
assess data precision, accuracy, completeness, representativeness,
and comparability of the measurements involved.
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Page 5 of 10
.16 Quality Assurance Systems Audit - a quantitative analysis or check
with a material or device with known properties or characteristics.
Such audits are performed periodically to determine the accuracy of
a measurement system.
.17 Quality Assurance Systems Audit - a systematic on-site qualitative
review of facilities, equipment, training, procedures, recordkeeping,
data validation, data management, and reporting aspects of the
total QA system.
(QA plans and audits are required to assess the capability of
the measurement system of applicant to generate data of the
required quality or to determine compliance of recipient with
i
the QA requirements of the Grant or Cooperative Agreement*
•18 Recipient — any individual, agency, or entity which has been
awarded assistance pursuant to 40 CFR 30.345.
.19 Regional Administrator - the Administrator of one of the ten EPA
Regional Offices or any person authorized to act for him.
.20 State-KPA Agreement - a statement between the State and EPA
delineating priority program activities to be carried out in the
State by either party; the document specifically covers work
to be undertaken during the fiscal year encompassed.
2.0 QUALITY ASSURANCE HEQUIBgMENTS
Recipients of Federal assistance must comply with QA guidelines
described in References 1 and 2, Appendix B.
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3.0 QUALITY ASSURANCE REVIEW
Recipients of assistance are responsible for the QA requirements,
established through negotiation, for all phases of the project. However,
EPA Project Officers and QA Officers both share responsibility for imple-
menting QA requirements in all Agency assisted environmental measurement
projects. Tom QAE-DCA (for EPA Internal Use Only) has been prepared to
assist EPA personnel in evaluating QA systems described in applications
for assistance involving environmental measurements for demonstration
projects.
The QA Officer of the sponsoring office will notify QA Officers of
all other offices having substantial Interest in the assistance activity
(program, Regional offices, and laboratories) for an opportunity to
comment if they so desire.
3.1 Assistance Conditions
Special conditions of the Assistance Agreement, Tart V of EPA Form
5700-20A (Revision 8-79) must include QA requirements of the agree-
ment. As a m-tri-tnmm condition of the assistance, the applicant must
state his QA policy, ensure the preparation of QA project plans for
all environmental measurements (see Reference 2, Appendix B), and
agree to participate in relevant EPA performance evaluation stu-
dies. As applicable, the following QA areas should also be ad-
dressed in Part V.
1. The intended use of the data and the associated acceptance
criteria for data quality
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2. Project requirements for precision, accuracy, representativeness,
completeness, and comparability
3. Selection of sampling sites and collection of samples
4. Sample identification, preservation, transportation, and storage
5. Selection of analytical methods
6. Standard QA/QC procedures to be followed.
The procedures to be used for the above QA areas should be
identified and discussed in sufficient detail to allow an
assessment of the QA practices to be followed during the project.
In most cases, an in—depth and detailed discussion of -each area
•will not be necessary at this time. for example, *here standard
procedures described in an EPA handbook or other standard
reference are ±o be followed, they may be included by reference.
Sections III through VI of Form QAR-DCA should be used to
determine specific QA requirements and schedules.
3.1*1 QA System Audit
Applicants will be informed in the Application Kit, or in pre-
application assistance, that they may be required to permit cm-
site systems audits as part of the preaward evaluation or during the
period of the performance under the agreement or both.
3.1.2 QA Performance Evaluation Studies
Performance evaluation studies will be a part of the agreement unless
no QC reference materials or devices
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In the event that no routine QC reference materials or devices are
available for the measurements involved, consideration should be
given to the use of common samples (or split samples) for cross-
comparison of results from the recipient with those of EPA.
3.2 Preaward Requirements
Prior to formal review and approval of applications for Federal
assistance, the Project Officer and QA Officer must determine if the
project requires the generation of environmentally-related measurement
data covered by the Agency's mandatory QA policy. If so, the Project
Officer must delineate the QA requirements, approved by the QA Officer,
which each applicant must include in the application. The following will
be included in the special instructions as reqirements for assistance and
will be submitted as part of the application.
1. A QA program plan as described in Section 3.2.1
2. Agreement, if requested, to participate in Performance Audits
using selected QC reference samples/devices or agreement to
document performance on such samples; such reference samples or
devices will be supplied by EPA at no cost to the recipient.
3. Agreement, to permit a QA systems audit by EPA of the applicant's/
recipient's facilities and operation.
Whenever appropriate, the QA Officer will ensure that the requirements
for QA project plans, QA performance audits, and QA systems audits are
met by an applicant or recipient.
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3.2.1 QA Program Plan
The application will include the following information concerning the
management of the QA effort for the proposed project:
1. A statement of policy concerning the applicant's commitment to
implement QA procedures and policies to assure generation of
data of known quality to meet project objectives.
2. An organizational structure showing the position of each key
person associated with the project.
3. A delineation of the QA authority and responsibilities of each
key person involved in generating or processing data.
3.2.2 QA Project Plan
The applicant nay be required to submit, as part of the assistance
proposal, a proposed QA project plan for the effort required by the
project. If not included as part of the assistance proposal, a QA
project plan must be developed as a separate, or identifiable part
of the recipient's work plan (see Section 3.3)
3.3 Award
In reviewing the QA requirements for assistance, the Project Officer
will, in accordance with Section 3.1, delineate the needs of the project
for various QA activities throughout the duration of the agreement. A
complete and detailed QA project plan will be required to be submitted as
a deliverable item. The QA project plan will be approved by the Project
Officer and QA Officer and shall be adhered to. Provisions will be made
in the assistance agreement for formal approval of any subsequent revisions
of the QA project plan.
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Date: 8-3-81
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3.4 QA Reports
Projects of 6 months or less may require only a final QA report.
Projects of longer duration may require periodic QA reports. The QA
reports will be separately identified progress reports and should
contain such information as:
1. Changes to QA management
2. Status of completion of QA project plan
3. Measures of data quality from the project
4. Significant quality problems, quality accomplishments, and status
of corrective actions
5. Results of QA performance audits
6. Results of QA system audits
7. Assessment of data quality in terms of precision, accuracy,
completeness, representativeness, and comparability
8. Quality-related training.
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APPENDIX A
C
QUALITY ASSURANCE REVIEW FOEMS
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QUALITY ASSURANCE REVIEW FOR EXTRAMURAL PROJECTS
(DEMONSTRATION PROJECTS AND COOPERATIVE AGREEMENTS)
I. GENERAL INFORMATION
1. Descriptive Title:
2. Sponsoring Program Office:
3. Responsible Region(s)
(where applicable)
4. Approximate Dollar Amount:
5. Duration:
II. DESCRIPTION OF WORK Yes No
This Project requires environmental measurements?
Tes No
HI. QUALITY ASSURANCE ASSISTANCE AGREEMENT REQUIREMENTS
(Projects requiring environmental measurements)
1. A written QA project plan is required as a part of
the agreement. (Required if the answer to II is
yes.)
2. Submission of a written QA project plan is to be
included in the assistance application.
3. Audit samples or devices are available for the
parameter(s) relevant to this project (complete on
reverse side).
A. Performance on available audit samples shall
be required, (complete on reverse side).
If not, attach justification for exception.
5. An on-site evaluation of applicant's facilities
will be made prior to -award to ensure that a QA
system is operational and exhibits the capability
for successful completion of this project (complete
on reverse side).
QA Form QAR-DCA, Revision No. 0, 1980
Page 1 of 2
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Measured Sample or Device for ior miring
Available Cross-Comparison Preaward Assistance Agreemen
(Yes or No)(Yes or No)(Yes or No)
1.
2.
3.
.4.
5.
6.
7.
8.
9.
10.
7. PLANNED DATES FOR QA SYSTEMS AUDITS Planned Audit Team
Preaward During Agreement
VI. QA REPORTS SCHEDULE
Progress Reports ___
Final Report
Before submission of the application to Assistance Approving Official, the signatures
below verify that the QA requirements have been established.
Project Offleer/Review Panel: Concurrence QA Officer:
Signature Date Signature Date
After the selection of the recipient, . the signatures below
verify that the preaward requirements have been satifactorily fulfilled.
Project Officer: Concurrence QA Officer:
Signature Date Signature Date
After signing, mall a copy of this form to the QAMS (RD-680) and to the
Assistance Approving and Award Officials.
QA Form QAR-DCA "~~ ~ " ~~ ~"~
Pa-e 2 of 2
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APPENDIX B
BIBLIOGRAPHY
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The following EPA documents or regulations provide guidance on
establishing QA programs for environmental measurement projects for
various media or pollutants. There are many other reference works also
available,
General
1. Guidelines and Specifications for Preparing Quality Assurance Program
Plans, QAMS-004-80
2. Guidelines ans Specifications for Preparing Quality Assurance Project
Plans, QAMS-007-80
Air
• A-l. EPA-600/9-76-005
«
A-2. EPA-600/4-77-027a
A-3. EPA-600/4-77-027b
A-4. EPA-600/4-76-044
A-5. Regulation
Water
¥-1. EPA-660/4-019
¥-2. EPA-600/4-78-017
W-3. EPA-600/4-75-008
HTIS-PB-253258/AS
Quality Assurance Handbook for Air Pollution
Measurement Systems. Volume I, Principles
(March, 1976)
Quality Assurance Handbook for Air Pollution
Measurement Systems. Volume II, Ambient Air
Specific Methods (May, 197.7J
Quality Assurance Handbook for Air Pollution
Measurement Systems. Volume III, Stationary
Source Specific Methods (August, 1977)
The EPA Program for the Standardization of
Stationary Source Emission Test Methodology-
- A Review (August, 1976)
Federal Register, May 10, 1979, Appendices
A&B
Handbook for Analytical Quality Control
in Water and Wastewater Laboratories
(March, 1979)
Procedures for the Evaluation of Environmental
Monitoring Laboratories (March, 1978)
Prescribed Procedures for Measurement of
Radioactivity in Drinking Water (March, 1976)
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'M "C1
U.S. EnvJr --""•* "^ Agency
Region v
230 Sf
Chicago, "-'
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Water (continued)
W-4. EPA-600/8-73-008
W-5. EPA-600/-78-017
W-6. EPA-600/4-79-020
W-7* EPA-600/2-79-046
W-8. Regulation
W-9. Regulation
W-10. Regulation
Manual for the Interim Certification of
Laboratories Involved in Analyzing Public
Drinking Water Supplies, Criteria, and
Procedures (August, 1978)
Microbiological Methods for Monitoring
and Environment (December, 1978)
Methods for Chemical Analysis of Water
and Wastes (March, 1979)
Quality Assurance Guidelines for IERL-CI
Project Officers (December, 1979)
Federal Register, December 1, 1976
Federal Register. November 29, 1979
Federal Register, December 18, 1979
Radiation
R-l. EPA-600/4-78-033
NTIS-PB-286981/AS
R-2. EPA-600/4-78-032
NTIS-PB-284850/AS
R-3. EPA-600/7-77-088
TVA-E-EP-77-4
NTIS-PB-277254/9BE
Radioactivity Standards Distribution Progri
1978-1979 (June, 1978)
Environmental Radioactivity Laboratory
Intercomparison Studies Program 1978-1979
(June, 1978)
Handbook for Analytical Quality Control and
Radioactivity Analytical Laboratories
(August, 1977)
Pesticides
P-1- EPA-600/1-79-008
P-2. Environmental
Toxicology Division,
Health Effects
Research Division,
U.S. EPA, Research
Triangle Park, NC
EPA-600/1-013
Manual of Analytical Quality Control for
Pesticides and Related Compounds in Human
and Environmental Samples (January, 1979)
Analysis of Pesticides Residues in Human and
Environmental Samples—A Compilation of
Methods Selected for Use in Pesticide
Monitoring Programs.
Guides for Quality Assurance in
Environmental Health Research (January,
1979).
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