October 26, 1998
MEMORANDUM
SUBJECT: Review of External Review Dr-aft Final of EPA Requirements for
Quality Assurance Project Plans (QA/R-5)
FROM: Nancy W. Wentwortr^Director /s/
Quality Assurance Division (8724R)
TO: EPA QA Managers
External Reviewers
Attached for your review is the External Review Draft Final, EPA
Requirements for Quality Assurance Project Plans (QA/R-5), dated October 1998.
This document formally defines the EPA requirements for Quality Assurance
Project Plans (QAPPs) developed by non-EPA organizations. EPA policy (EPA
Order 5360.1'CHG 1, July 1998) requires an approved QAPP for all environmental
data collection and use by or for the Agency.
This external review is the last step before this document is finalized and
invoked in EPA financial agreements to satisfy the requirements of this policy.
Earlier versions of R-5 have been widely circulated inside and outside of the Agency
which have yielded many helpful comments. This draft final incorporates revisions
necessary to assure conformance with the EPA Order 5360.1 CHG 1.
The QAPP is the "blueprint" by which individual projects are implemented
and assessed. The QAPP documents the results of the systematic planning process
used to design the work activity and the performance measures for its successful
completion. The development, review, approval, and implementation of the QAPP
is part of the mandatory Agency-wide Quality System defined by the Order. This
policy requires all organizations performing environmental programs for EPA to
develop and implement procedures and processes to ensure that data collected or
compiled for use in Agency decision making are of the type and quality needed and
expected for their intended use.
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EPA's Agency-wide Quality System is based on the national consensus
standard, ANSI/ASQC E4-1994, Specifications and Guidelines for Environmental
Data Collection and Environmental Technology Programs. ANSI/ASQC E4-1994
defines the requisite management and technical elements necessary to develop and
implement a quality system for an organization's environmental programs. The
ANSI/ASQC E4 standard requires a QAPP for environmental data operations and
the requirements given in this document are consistent with the E4 standard. EPA
has invoked ANSI/ASQC E4-1994 through 48 CFR Part 46 for contracts (to be
issued shortly) and 40 CFR Part 30 for grants and cooperative agreements to
institutions of higher education, hospitals, and other non-profit recipients of
financial assistance. The current quality assurance requirements in 40 CFR Part
31, for State, local, and Tribal governments, allows EPA flexibility in defining an
acceptable QA program. It is EPA policy that an "acceptable QA program" is one
that conforms to the E4 standard. While 40 CFR Part 31 does not currently invoke
E4, it is expected to be revised in the future to specifically invoke E4. Compliance
with the requirements of this document will be considered consistent with the
QAPP requirements of E4. In the meantime, the Office of Grants and Debarment
will provide standard terms and conditions that address QAPP documentation
requirements for assistance agreements covered by 40 CFR Part 31.
Please note that this document will not undergo a review through the Federal
Register since EPA is invoking this document as a method for complying with the
requirements of E4. Also note that the content of this document has undergone an
Agency-wide review and has been issued as internal policy as Chapter 5 of EPA
Order 5360, The EPA Quality Manual for Environmental Programs (July 1998). In
addition, this document is supplemented by the EPA Guidance for Quality
Assurance Project Plans (QA/G-5) (EPA 1998) which provides suggestions on
preparing, reviewing, and implementing QAPPs. Copies of any of these references
and additional copies of this review document are available on the world wide web
at "es.epa.gov/ncerqa/qa/index.html" or may be obtained directly from EPA's Quality
Assurance Division (202/564-6830).
In order to complete a comprehensive peer review of this document, I ask that
you carefully review the document to answer the following questions:
Does R-2 conform to the requirements defined by ASQC/ANSI
E4-1994?
Are there any quality management processes missing from the
document?
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Is the text readable and clear in its meaning? If the text is unclear,
please provide alternative language to clarify the current text.
Comments should be submitted by November 30, 1998 to:
QAPP Requirement Comments
Quality Assurance Division (8724R)
U.S. Environmental Protection Agency
401 M. Street, SW
Washington, DC 20460
In addition, comments may be faxed to (202) 565-2441, ATTN: QAPP Requirements
Comments or e-mailed to ord-qad@epa.gov.
I appreciate your time spent in reviewing this document. Your input is very
important. I strongly believe that these requirements will assist both EPA and our
extramural agreement holders in ensuring that data collected or complied for EPA
are of the type and quality needed to support timely, cost-effective decision making.
Attachment
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EPA REQUIREMENTS
FOR
QUALITY ASSURANCE PROJECT PLANS
FOR ENVIRONMENTAL DATA OPERATIONS
EPA QA/R-5
United States Environmental Protection Agency
Quality Assurance Division
Washington, DC 20460
EXTERNAL REVIEW DRAFT FINAL
OCTOBER 1998
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FOREWORD
The U.S. Environmental Protection Agency (EPA) has developed the Quality Assurance
Project Plan (QAPP) as an important tool for project managers and planners to document the
type and quality of data needed for environmental decisions and to provide a blueprint for
collecting and assessing those data from environmental programs. The development, review,
approval, and implementation of the QAPP is part of the mandatory Agency-wide Quality
System that requires all organizations performing work for EPA to develop and operate
management structures and processes for ensuring that data collected or compiled for use in
Agency decisions are of the type and quality needed and expected for their intended use. The
QAPP is an integral part of the fundamental principles and practices that form the foundation of
the EPA Quality System.
This document contains the same requirements as Chapter 5 of EPA Order 5360 (July
1998), The EPA Quality Manual for Environmental Programs, which has been developed for
internal use by EPA organizations. This document provides the QAPP requirements for
organizations that conduct environmental data operations in behalf of EPA through contracts,
financial assistance agreements, and inter-agency agreements. A companion document, EPA
Guidance for Quality Assurance Project Plans (QA/G-5) (EPA 1998c) provides suggestions on
preparing, reviewing, and implementing QAPPs. The guidance is intended for use by both EPA
and non-EPA organizations.
This document is one of the U.S. Environmental Protection Agency Quality System Series
requirements and guidance documents. These documents describe the EPA policies and
procedures for planning, implementing, and assessing the effectiveness of the Quality System.
Requirements documents (identified as EPA QA/R-x) establish criteria and mandatory
specifications for quality assurance (QA) and quality control (QC) activities. Guidance
documents (identified as EPA QA/G-x) provide suggestions and recommendations of a non-
mandatory nature for using the various components of the Quality System.
Questions regarding this document or other Quality System Series documents should be
directed to:
U.S. EPA
Quality Assurance Division (8724R)
401 M Street, SW
Washington, DC 20460
Phone: (202) 564-6830
FAX: (202)565-2441
e-mail: ord-qad@epa.gov
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Copies of EPA Quality System Series documents may be obtained from the Quality
Assurance Division or by downloading them from the QAD Home Page at:
URL Address: http://es.epa.gov/ncerqa/qa/index.html
11
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TABLE OF CONTENTS
Page
CHAPTER 1. INTRODUCTION 1
1.1 BACKGROUND 1
1.2 QAPPs, THE EPA QUALITY SYSTEM, AND ANSI/ASQC E4 2
1.3 SUPERSESSION 3
1.4 PERIOD OF APPLICABILITY 3
1.5 ADDITIONAL RESOURCES 3
CHAPTER 2. QUALITY ASSURANCE PROJECT PLAN REQUIREMENTS 5
2.1 POLICY 5
2.2 PURPOSE 5
2.3 APPLICABILITY 5
2.4 GENERAL CONTENT AND DETAIL REQUIREMENTS 6
2.5 QAPP PREPARATION RESPONSIBILITIES AND APPROVALS 6
2.6 QAPP IMPLEMENTATION 7
2.7 QAPP REVISION 7
2.8 QAPPS AND PQAPS 8
CHAPTER 3. QAPP ELEMENTS 9
3.1 CONTENT REQUIREMENTS 9
3.2 GROUP A: PROJECT MANAGEMENT 10
3.2.1 Al - Title and Approval Sheet 11
3.2.2 A2 - Table of Contents , 11
3.2.3 A3 - Distribution List 12
3.2.4 A4 - Project/Task Organization 12
3.2.5 A5 - Problem Definition/Background 12
3.2.6 A6 - Project/Task Description 12
3.2.7 A7 - Quality Objectives and Criteria for Measurement Data 13
3.2.8 A8 - Special Training Requirements/Certification 13
3.2.9 A9 - Documentation and Records 13
3.3 GROUP B: MEASUREMENT/DATA ACQUISITION 14
3.3.1 Bl- Sampling Process Design (Experimental Design) 15
3.3.2 B2 - Sampling Methods Requirements 15
3.3.3 B3 - Sample Handling and Custody Requirements 16
3.3.4 B4 - Analytical Methods Requirements 16
3.3.5 B5 - Quality Control Requirements -. . 16
3.3.6 B6 - Instrument/Equipment Testing, Inspection, and Maintenance
Requirements 17
3.3.7 B7 - Instrument Calibration and Frequency 17
in
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Page
3.3.8 B8 - Inspect!on/Acceptance Requirements for Supplies and
Consumables 18
3.3.9 B9 - Data Acquisition Requirements (Non-direct Measurements) 18
3.3.10 BIO - Data Management 18
3.4 GROUP C: ASSESSMENT/OVERSIGHT 19
3.4.1 Cl - Assessments and Response Actions 19
3.4.2 C2 - Reports to Management 19
3.5 GROUP D: DATA VALIDATION AND USABILITY 20
3.5.1 Dl - Data Review, Validation, and Verification Requirements 20
3.5.2 D2 - Validation and Verification Methods 20
3.5.3 D3 - Reconciliation with User Requirements 20
CHAPTER 4. PQAP ELEMENTS 21
REFERENCES 23
APPENDIX A. CROSSWALKS AMONG QUALITY ASSURANCE
DOCUMENTS A-l
A.I BACKGROUND A-l
A.2 CROSSWALK BETWEEN EPA QA/R-5 AND QAMS-005/80 A-l
A.3 CROSSWALK BETWEEN THE DQO PROCESS AND THE QAPP A-3
APPENDIX B. TERMS AND DEFINITIONS B-l
FIGURES
Page
1. The EPA Quality System 4
2. Example Document Control Format 12
TABLES
Page
1. Group A: Project Management Elements 11
2. Group B: Measurement/Data Acquisition Elements 14
3. Group C: Assessment/Oversight Elements 19
4. Group D: Data Validation and Usability 20
IV
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CHAPTER 1
INTRODUCTION
1.1 BACKGROUND
The Environmental Protection Agency (EPA) annually spends more than several hundred
million dollars in the collection of environmental data.' In addition, the regulated community
may spend as much as an order of magnitude more each year in complying with Agency
requirements. There are several important concerns common to environmental data operations2
for both the EPA and the regulated community. Both groups want to make decisions using the
right data collected properly the first time.
The complexity of environmental data operations demands that a systematic process and
structure for quality must be established if decision makers are to have the necessary confidence
in the quality of data that support their decisions. This process and structure must include the
means to determine when the data are not fully usable and what to do about the situation. This
process and structure is provided by the quality system for the organization conducting the
environmental data operations. EPA Order 5360.1 CHG 1 requires that the collection of
environmental data by and on behalf of the Agency be supported by a mandatory quality system.
Moreover, EPA Order 5360.1 CHG 1 requires that all environmental data used in decision
making be supported by an approved Quality Assurance Project Plan (QAPP). These
requirements are externalized through several mechanisms, including:
° 48 CFR Part 46, for contractors;
° 40 CFR Parts 30, 31, and 35 for assistance agreement recipients;
° and other mechanisms, such as consent agreements in enforcement actions.
The QAPP integrates all technical and quality aspects for the life-cycle of the project,
including planning, implementation, and assessment. The purpose of the QAPP is to document
planning results for environmental data operations and to provide a project-specific "blueprint"
for obtaining the type and quality of environmental data needed for a specific decision or use.
The QAPP documents how quality assurance (QA) and quality control (QC) are applied to an
1 Environmental data include any measurements or information that describe environmental processes, location, or
conditions; ecological or health effects and consequences; or the performance of environmental technology. For
EPA, environmental data include information collected directly from measurements, produced from models, and
compiled from other sources such as data bases or the literature.
2 This term is used throughout this document to refer to activities involving the acquisition, analysis, and evaluation
of environmental data. See Appendix B for a more complete definition.
External Review Draft Final
EPA QA/R-5 1 October 1998
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environmental data operation to assure that the results obtained are of the type and quality
needed and expected.
The ultimate success of an environmental program or project depends on the quality of
the environmental data collected and used in decision-making, and this may depend significantly
on the adequacy of the QAPP and its effective implementation. This planning must include the
"stakeholders" (i.e., the data users, data producers, decision makers, etc.) to ensure that all needs
are defined adequately and that the planning for quality addresses the specific needs defined.
While time spent on such planning may seem unproductive and costly, the penalty for ineffective
planning includes greater cost and lost time. In the chapters to follow, the elements of the QAPP
are discussed in detail. These elements represent the information that EPA believes to be
necessary for data operations involving the characterization of environmental processes and
conditions.
This document presents specifications and instructions for the information that must be
contained in a QAPP for environmental data operations performed on behalf of the EPA by
extramural organizations. The document also discusses the procedures for review, approval,
implementation and revision of QAPPs. Users of this document should assume that all of the
elements described herein are required in the QAPPs unless otherwise directed by EPA.
1.2 QAPPs, THE EPA QUALITY SYSTEM, AND ANSI/ASQC E4
EPA Order 5360.1 CHG 1 establishes a mandatory Agency-wide Quality System that
applies to all organizations performing work for EPA as well as to EPA. (The authority for the
requirements defined by the Order are contained in the applicable regulations for extramural
agreements.) These organizations must ensure that data collected for the characterization of
environmental processes and conditions are of the appropriate type and quality for their intended
use and that environmental technologies are designed, constructed, and operated according to
defined expectations. The QAPP is a key component of the EPA Quality System as shown in
Figure 1.
EPA policy is based on the national consensus standard, ANSI/ASQC E4-1994,
Specifications and Guidelines for Environmental Data Collection and Environmental
Technology Programs. The ANSI/ASQC E4-1994 provides the basis for the quality system for
an organization's environmental programs. The document provides the requisite management
and technical elements necessary for developing and implementing a quality system. The
document first describes the quality management elements that are generally common to
environmental problems, regardless of their technical scope. The document then discusses the
specifications and guidelines that apply to project-specific environmental activities involving the
generation, collection, analysis, evaluation, and reporting of environmental data. Finally, the
document contains the minimum specifications and guidelines that apply to the design,
construction, and operation of environmental technology.
External Review Draft Final
EPA QA/R-5 2 October 1998
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The ANSI/ASQC E4 standard requires two principal forms of quality system
documentation: the quality management plan (QMP), which addresses the Part A requirements,
and the quality assurance project plan (QAPP), which addresses the Part B requirements. The
QMP documents how an organization structures its quality system, defines and assigns QA and
QC responsibilities, and describes the processes and procedures used to plan, implement, and
assess the effectiveness of the quality system. The QMP may be viewed as the "umbrella"
document under which individual projects are conducted. The requirements defined by EPA for
QMPs are given in EPA Requirements for Quality Management Plans (QA/R-2) (EPA 1998a).
The QAPP is the "blueprint" by which individual projects are implemented and assessed.
The QAPP documents the results of the systematic planning process used to design the work
activity and the performance measures for its successful completion. This document defines the
EPA requirements for QAPPs. Figure 1 shows the relationship between the QMP and the QAPP
in the EPA Quality System.
1.3 SUPERSESSION
This document replaces QAMS-005/80, Interim Guidelines and Specifications for
Preparing Quality Assurance Project Plans (EPA 1980) in its entirety.
1.4 PERIOD OF APPLICABILITY
Per EPA Order 5360, this document shall be valid for a period of five years from the
official date of publication. After five years, this document shall either be reissued, revised, or
removed from the EPA Quality System.
1.5 ADDITIONAL RESOURCES
Guidance on developing, preparing, reviewing, and approving QAPPs may be found in a
companion document, EPA Guidance for Quality Assurance Project Plans (QA/G-5) (EPA
1998c). This guidance discusses the application of the QAPP requirements given in this
document to data collection activities and provides examples of the QAPP requirements along
with helpful checklists. Other documents that are useful for the development of a QAPP include:
° Guidance for the Data Quality Objectives Process (QA/G-4), (EPA 1994)
° Guidance for the Preparation of Standard Operating Procedures for Quality-
Related Documents (QA/G-6), (EPA 1995)
0 Guidance for Data Quality Assessment: Practical Methods for Data Analysis
(QA/G-9), (EPA 1998b)
These documents provide guidance on activities critical to successful environmental data
operations and complement the QAPP preparation effort.
External Review Draft Final
EPA QA/R-5 3 October 1998
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o
UJ
o
oc
Q.
Consensus Standards
ANSI/ASQC E4
ISO 9000 Series
External EPA Policies
Contracts - 48 CFR Part 46
Assistance Agreements - 40 CFR
Parts 30, 31, and 35
Internal EPA Policies
EPA Order 5360.1 CHG 1
EPA Quality Manual (5360)
EPA Program &
Regional Policy
QA Annual Report
and Work Plan
(Internal EPA)
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:
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EPA QA/R-5
External Review Draft Final
October 1998
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CHAPTER 2
QUALITY ASSURANCE PROJECT PLAN
REQUIREMENTS
2.1 POLICY
All work performed by extramural organizations on behalf of or funded by EPA that
involves the acquisition of environmental data generated from direct measurement activities,
collected from other sources, or compiled from computerized data bases and information systems
shall be implemented in accordance with an approved QAPP developed using a systematic
planning process based on the "graded approach"3. Work performed on behalf of EPA includes
activities performed under contracts (including work assignments, task orders, delivery orders,
etc.), assistance agreements, or interagency agreements. No work covered by this requirement
and funded by EPA shall be implemented without an approved QAPP available prior to the start
of the work except under circumstances requiring immediate action to protect human health and
the environment or operations conducted under police powers. These requirements will be
negotiated into interagency agreements, including sub-agreements, and, in some cases, included
in enforcement consent agreements and orders.
2.2 PURPOSE
The QAPP is a critical planning document for any environmental data operation. The
QAPP documents how environmental data operations are planned, implemented, and assessed
with respect to quality during the life cycle of a program, project, or task. The purpose of the
QAPP is to define in detail how specific QA and QC activities will be applied during a particular
project operation.
2.3 APPLICABILITY
These QAPP requirements apply to all environmental programs that acquire, generate, or
compile environmental data and that are performed on behalf of or funded by EPA. These
operations include work performed through contracts, work assignments, deliver orders, task
orders, cooperative agreements, interagency agreements, State-EPA agreements, State, local and
Tribal Financial Assistants/Grants, Research Grants, and in response to statutory or regulatory
requirements and consent agreements negotiated as part of enforcement actions. These
requirements will be negotiated into interagency agreements, including sub-agreements, and, in
some cases, included in enforcement consent agreements and orders. Where specific Federal
regulations require QA and QC, QAPPs shall be prepared, reviewed, and approved in accordance
3 A graded approach is the process of basing the level of application of managerial controls applied to an item or
work according to the intended use of the results and the degree of confidence needed in the quality of the results.
External Review Draft Final
EPA QA/R-5 5 October 1998
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with the specifications contained in this document for the acquisition of environmental data
unless explicitly superseded by the regulation.
2.4 GENERAL CONTENT AND DETAIL REQUIREMENTS
The QAPP must be composed of standardized, recognizable elements covering the entire
project from planning, through implementation, to assessment. Chapter 3 of this document
describes specific content requirements for QAPPs submitted to EPA. Each EPA organization
will define their QAPP requirements in their QMP. All applicable elements defined by the EPA
organization sponsoring the work must be addressed in the QAPP.
In some cases, it may be necessary to add special requirements to the QAPP. The EPA
organization sponsoring the work has the authority to define any special requirements beyond
those listed in this document. If no additional requirements are specified, the QAPP shall, at
least, address all required elements.
The "graded approach" concept recognizes that a "one size fits all" concept of QAPPs
will not be appropriate for most environmental programs. Environmental data collection
operations encompass diverse and complex activities, including rule making, long-term
monitoring, research and development, compliance and enforcement, and human health and
ecological effects studies. As a result, some environmental data operations may only require a
qualitative discussion of the experimental process and its objectives while others may require
extensive documentation in order to adequately describe a complex environmental program.
Consequently, the content and level of detail in each QAPP will vary according to the nature of
the work being performed and the intended use of the data. The decision on QAPP content and
level of detail belongs to the EPA organization responsible for the work to be done. This is
necessary to acknowledge and accommodate regulatory authorities that may exist and that may
take some precedence over the results of the planning process.
2.5 QAPP PREPARATION RESPONSIBILITIES AND APPROVALS
The QAPP may be prepared by a contractor, an assistance agreement holder, or another
Federal agency under an interagency agreement. Except where specifically delegated, all QAPPs
prepared by non-EPA organizations must be approved by EPA before implementation.
It is EPA policy that the QAPP be reviewed and approved by an authorized EPA reviewer
to ensure that the QAPP contains the appropriate content and level of detail. This may be the
EPA project manager4 with the assistance and approval of the EPA QA Manager or by the EPA
QA Manager alone, as defined by the organization's QMP. In some cases, the authority to
4 This term refers to the responsible EPA official for the project and includes such descriptors as Project Officer,
Delivery Order Project Officer, Work Assignment Manager, and Principal Investigator.
External Review Draft Final
EPA QA/R-5 6 October 1998
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review and approve QAPPs is delegated to a QA Coordinator in another part of the EPA
organization covered by the same QMP. In other cases, the authority to review and approve
QAPPs is delegated in writing by EPA to another organization (i.e., a Federal agency or a State
under an EPA-approved QMP) when the environmental data collection program itself has been
delegated to the other organization for implementation. In such cases, it is possible that the EPA
project manager and EPA QA Manager may not be involved in the review and approval steps.
2.6 QAPP IMPLEMENTATION
None of the environmental work addressed by the QAPP shall be started until the initial
QAPP has been approved and distributed to project personnel except under limited special
circumstances. These include situations requiring immediate action to protect human health and
the environment or operations conducted under police powers. Conditional approval to a QAPP
may be granted to permit some work to begin while non-critical deficiencies in the QAPP are
being resolved. Subject to these exceptions, it is the responsibility of the organization
performing the work to assure that no environmental data are acquired before the QAPP is
approved and received by project personnel.
All QAPPs shall be implemented as approved for the intended work. The organization
performing the work is responsible for implementing the approved QAPP and to ensure that all
personnel involved in the work have copies of the approved QAPP and all other necessary
planning documents. These personnel should understand the requirements prior to the start of
data generation activities.
2.7 QAPP REVISION
The approved QAPP must be implemented as prescribed; however, it is not inflexible.
When conditions or requirements change during environmental data operations, the QAPP must
be revised, then reviewed and approved in the same manner as the original QAPP. Because of
the complex and diverse nature of environmental data operations, changes to original plans are
often needed. When such changes occur, the approving official will determine if the change
significantly impacts the technical and quality objectives of the project. When a substantive
change is warranted, the originator of the QAPP shall modify the QAPP to document the change
and submit the revision for approval by the same authorities that performed the original review.
Only after the revision has been approved and received (at least verbally with written follow-up)
by project personnel, shall the change be implemented.
It is absolutely essential that the QAPP be kept current and that all personnel involved in
the work effort have easy access to a current version of the QAPP. For programs or projects of
long duration, such as multi-year monitoring programs, the QAPPs shall be reviewed at least
annually by the Project Manager. When revisions are necessary to reflect current needs, the
QAPP must be revised and resubmitted for review and approval.
External Review Draft Final
EPA QA/R-5 7 October 1998
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2.8 QAPPS AND PQAPS
As indicated earlier, environmental data operations vary widely in complexity and not all
QAPPs should demand the same level of comprehensiveness. Two general types of QAPP
formats are generally acceptable when submitting QAPPs to EPA for review and approval:
° Quality Assurance Project Plan (QAPP) Document: The QAPP document is
the most frequently used format and applies to most environmental data collection
work. Chapter 3 of this document contains the specific requirements for the
QAPP Document. It will apply to contracts, work assignments, inter-agency
agreements, large cooperative agreements and assistance agreements, etc., that
include post-award environmental monitoring, sampling and analysis activities,
and long-term studies.
° Proposal Quality Assurance Plan (PQAP) (formerly QA Narrative
Statement): The PQAP is a brief 2-3 page document that provides in a narrative
form the necessary documentation of QA and QC elements to be applied to small
projects and tasks. The PQAP has been also called the "QA Narrative Statement."
Chapter 4 of this document contains the specific requirements for PQAP.
Typically, PQAPs will be submitted as part of proposal or financial assistance
application in order to provide evidence of the offerer/applicant's capabilities to
satisfy QA and QC requirements in the applicable extramural agreement
regulations. In some cases, a full QAPP Document will be required after an
award is made. The PQAP may be applied as an official QAPP to small tasks
(including short duration tasks), research assistance agreements, and related work
in which the scope of work is broadly defined. This will be determined by the
EPA project manager.
The choice of format is made by the EPA project manager (or award official).
External Review Draft Final
EPA QA/R-5 8 October 1998
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CHAPTER 3
QAPP ELEMENTS
3.1 CONTENT REQUIREMENTS
The QAPP is a formal document describing in comprehensive detail the necessary QA,
QC, and other technical activities that must be implemented to ensure that the results of the work
performed will satisfy the stated performance criteria. The QAPP provides the "road map" for
QA and QC for a specific project. The QAPP must provide sufficient detail to demonstrate that:
° the project technical and quality objectives are identified and agreed upon;
° the intended measurements or data acquisition methods are appropriate for
achieving project objectives;
° assessment procedures are sufficient for confirming that data of the type and
quality needed and expected are obtained; and
° any limitations on the use of the data can be identified and documented.
Most environmental data operations require the coordinated efforts of many individuals, possibly
including managers, engineers, scientists, statisticians, and others. The QAPP must integrate the
contributions and requirements of everyone involved into a clear, concise statement of what is to
be accomplished, how it will be done, and by whom. It must provide understandable instructions
to those who must implement the QAPP, including the field sampling team, the analytical
laboratory, and the data reviewers. The use of national standards and practices and inclusion of
standard operating procedures is encouraged in all aspects of the QAPP.
In order to be effective, the QAPP must specify the level or degree of QA/QC needed for
the particular environmental data operations. Because this will vary according to the purpose
and type of work being done, EPA believes that the graded approach should be used in planning
the work. This means that the QA and QC applied to a project will be commensurate with:
° the purpose of the environmental data collection (e.g., enforcement, research and
development, rulemaking),
0 the type of work to be done (e.g., pollutant monitoring, site characterization,
bench level proof of concept experiments), and
° the intended use of the results (e.g., compliance determination, selection of
remedial technology, development of environmental regulation).
External Review Draft Final
EPA QA/R-5 9 October 1998
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The QAPP must be composed of standardized, recognizable elements covering the entire
project from planning, through implementation, to assessment. The QAPP elements that follow
are presented in that order and have been arranged for convenience into four general groups. The
four groups of elements and their intent are summarized as follows:
A Project Management - This group of QAPP elements covers the basic area of
project management, including the project history and objectives, roles and
responsibilities of the participants, etc. These elements ensure that the project has
a defined goal, that the participants understand the goal and the approach to be
used, and that the planning outputs have been documented.
B Measurement/Data Acquisition - This group of QAPP elements covers all aspects
of measurement systems design and implementation, ensuring that appropriate
methods for sampling, analysis, data handling, and QC are employed and are
properly documented.
C Assessment/Oversight - This group of QAPP elements addresses the activities for
assessing the effectiveness of the implementation of the project and associated
QA and QC. The purpose of assessment is to ensure that the QAPP is
implemented as prescribed.
D Data Validation and Usability - This group of QAPP elements covers the QA
activities that occur after the data collection phase of the project is completed.
Implementation of these elements ensures that the data conform to the specified
criteria, thus achieving the project objectives.
All applicable elements defined by the EPA organization sponsoring the work must be
addressed in the QAPP. If an element is not applicable, state this in the QAPP. Documentation,
such as an approved Work Plan, Standard Operating Procedures (SOPs), etc., may be referenced
in response to a particular required QAPP element to reduce the size of the QAPP and the time
required for preparation and review. All referenced documents must be attached to the QAPP
itself or be placed on file with the appropriate EPA office and available for routine referencing
when needed. Such references must be kept current by the submitter. The QAPP shall also
address related QA planning documentation (e.g., Quality Management Plans) from
subcontractors or suppliers of services critical to the technical and quality objectives of the
project or task.
3.2 GROUP A: PROJECT MANAGEMENT
This group of QAPP elements (Table 1) covers the basic area of project management,
including the project history and objectives, roles and responsibilities of the participants, etc.
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These elements ensure that the project has a defined goal, that the participants understand the
goal and the approach to be used, and that the planning outputs have been documented.
Table 1. Group A: Project
Management Elements
Al
A2
A3
A4
A5
A6
A7
A8
A9
Title and Approval Sheet
Table of Contents
Distribution List
Project/Task Organization
Problem Definition/Background
Project/Task Description
Quality Objectives and Criteria for
Measurement Data
Special Training Requirements/Certification
Documentation and Records
3.2.1 Al - Title and Approval Sheet
On the Title and Approval Sheet, list the title of the plan, the name of the organization(s)
implementing the project, and the names, titles, signatures of appropriate approving officials and
their approval dates. Approving officials include:
0 Organization' s Project Manager
e Organization's Quality Assurance Manager
° EPA Project Manager
° EPA Quality Assurance Manager
° Others Offices, as needed (e.g., field operations manager, laboratory managers,
State and other Federal Agency officials)
3.2.2 A2 - Table of Contents
List the table of contents for the document, including sections, figures, tables, references,
and appendices. Document control format (Figure 2) may be required by the EPA Project
Manager and QA Manager. When required, apply the document control format in the upper
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right-hand corner of each page following the Title and Approval Sheet. An example document
control format is contained in Figure 2.
Section No. _
Revision No.
Date
Page of.
Figure 2. Example Document
Control Format
3.2.3 A3 - Distribution List
List the individuals and their organizations who will receive copies of the approved
QAPP and any subsequent revisions. Include all persons responsible for implementation
(including managers), the QA managers, and representatives of all groups involved.
3.2.4 A4 - Project/Task Organization
Identify the individuals or organizations participating in the project and discuss their
specific roles and responsibilities. Include the principal data users, the decision-makers, the
project QA manager, and all persons responsible for implementation. The project quality
assurance manager must be independent of the unit generating the data. (This does not include
being independent of senior officials, such as corporate managers or agency administrators, who
are nominally, but not functionally, involved in data generation, data use, or decision-making.)
Provide a concise organization chart showing the relationships and the lines of
communication among all project participants. Include other data users who are outside of the
organization generating the data, but for whom the data are nevertheless intended. The
organization chart must also identify any subcontractor relationships relevant to environmental
data operations.
3.2.5 A5 - Problem Definition/Background
State the specific problem to be solved or decision to be made. Include sufficient
background information to provide a historical and scientific perspective for this particular
project.
3.2.6 A6 - Project/Task Description
Provide a description of the work to be performed and the schedule for implementation.
This discussion may not need to be lengthy or overly detailed, but it should give an overall
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picture of how the project will resolve the problem or question described in A5. Describe in
general terms the following, as needed:
° Measurements that will be made during the course of the project.
» Applicable technical, regulatory, or program-specific quality standards, criteria, or
objectives.
° Any special personnel and equipment requirements.
° The assessment tools needed (i.e., program technical reviews, peer reviews,
surveillances, and technical audits) for the project.
° A schedule for the work to be performed.
° Project and quality records required, including the types of reports needed.
3.2.7 A7 - Quality Objectives and Criteria for Measurement Data
The QAPP must include a statement of the project quality objectives and measurement
performance criteria. EPA requires the use of a systematic planning process to define these
quality objectives and performance criteria. To support this requirement, EPA has developed a
systematic planning process based on a graded approach for environmental decision making
called the Data Quality Objectives (DQO) Process. The DQO Process is the Agency's preferred
planning process and provides quality objectives and performance criteria based on the user's
determination of tolerable error in the results. For details on the DQO Process and guidance on
how and when it may be used, see the Guidance for the Data Quality Objectives Process
(QA/G-4) (EPA 1994).
3.2.8 A8 - Special Training Requirements/Certification
Identify and describe any specialized training or certification requirements needed by
personnel in order to successfully complete the project or task. Discuss how such training will
be provided and how the necessary skills will be assured and documented.
3.2.9 A9 - Documentation and Records
Describe the process and responsibilities for ensuring that the most current approved
version of the QAPP is available.
Itemize the information and records which must be included in the data report package
and specify the desired reporting format for hard copy and electronic forms, when used. Records
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can include raw data, field logs, instrument printouts, and results of calibration and QC checks.
Identify any other records and documents applicable to the project, such as audit reports, interim
progress reports, and final reports, that will be produced. Specify the level of detail of the field
sampling and/or laboratory analysis narrative needed to provide a complete description of any
difficulties encountered during sampling or analysis. The narrative refers to an annotated
summary of the analytical work performed by a laboratory that describes in narrative form what
activities were performed and identifies any problems encountered. This information is
important to the data user when interpreting the data received.
Specify or reference all applicable requirements for the final disposition of records and
documents, including location and length of retention period.
3.3 GROUP B: MEASUREMENT/DATA ACQUISITION
This group of QAPP elements (Table 2) covers all aspects of measurement systems
design and implementation, ensuring that appropriate methods for sampling, analysis, data
handling, and QC are employed and are documented. The following QAPP elements describe
the requirements related to the actual methods to be used for the:
° collection, handling, and analysis of samples;
e measured parameters obtained from other sources (e.g., data contained in a
computer data base from previous sampling activities, data compiled from
surveys, data taken from the literature); and
° the management (i.e., compiling, handling) of the data.
The methods described in these elements should have been summarized earlier in element A6.
The purpose here is to provide detailed information on the methods. If the designated methods
are well documented and are readily available to all project participants, citations are adequate.
If these methods are not well documented, detailed copies of the methods and/or SOPs must
accompany the QAPP either in the text or as attachments.
Table 2. Group B: Measurement/Data
Acquisition Elements
Bl
B2
B3
B4
Sampling Process Design (Experimental Design)
Sampling Methods Requirements
Sample Handling and Custody Requirements
Analytical Methods Requirements
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Table 2. Group B: Measurement/Data
Acquisition Elements
B5
Quality Control Requirements
B6
Instrument/Equipment Testing, Inspection, and Maintenance
Requirements
B7
Instrument Calibration and Frequency
B8
Inspection/Acceptance Requirements for Supplies and Consumables
B9
Data Acquisition Requirements (Non-direct Measurements)
BIO
Data Management
3.3.1 Bl- Sampling Process Design (Experimental Design)
Describe the experimental design or data collection design for the project, including as
appropriate:
° the types and numbers of samples required,
• the design of the sampling network,
° the sampling locations and frequencies,
° sample matrices,
• measurement parameters of interest, and
e the rationale for the design.
Classify all measurements as critical (i.e., required to achieve project objectives) or non-critical
(informational purposes only).
3.3.2 B2 - Sampling Methods Requirements
Describe the procedures for collecting samples and identify the sampling methods and
equipment, including any implementation requirements, sample preservation requirements,
decontamination procedures, and materials needed. Identifying sampling methods by number,
date, and regulatory citation (as appropriate) is often sufficient. If a method allows the user to
select from various options, then the method citations should state exactly which options are
being selected. Describe specific performance requirements for the method. For each sampling
method, identify any support facilities needed. The discussion should also address what to do
when a failure in the sampling or measurement system occurs, who is responsible for corrective
action, and how the effectiveness of the corrective action shall be determined and documented.
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Describe the process for the preparation and decontamination of sampling equipment,
including the disposal of decontamination by-products; the selection and preparation of sample
containers, sample volumes, preservation methods, and maximum holding times to sample
extraction and/or analysis.
3.3.3 B3 - Sample Handling and Custody Requirements
Describe the requirements and provisions for sample handling and custody in the field,
laboratory, and transport, taking into account the nature of the samples, the maximum allowable
sample holding times before extraction or analysis, and available shipping options and schedules.
Sample handling includes preservation, packaging, shipment from the site, and storage at the
laboratory. Examples of sample labels, custody forms, and sample custody logs should be
included.
3.3.4 B4 - Analytical Methods Requirements
Identify the analytical methods and equipment required, including sub-sampling or
extraction methods, laboratory decontamination procedures and materials (such as in the case of
hazardous or radioactive samples), waste disposal requirements (if any), and any specific
performance requirements for the method. Address what to do when a failure in the analytical
system occurs and who is responsible for corrective action and how the effectiveness of the
corrective action shall be determined and documented. Specify the laboratory turnaround time
needed, if important to the project schedule.
Identifying analytical methods by number, date, and regulatory citation (as appropriate) is
often sufficient. If a method allows the user to select from various options, then the method
citations should state exactly which options are being selected. For non-standard methods, such
as unusual sample matrices and situations, appropriate method performance study information is
needed to confirm the performance of the method for the particular matrix. If previous
performance studies are not available, they must be developed during the project and included as
part of the project results.
3.3.5 B5 - Quality Control Requirements
Identify the QC procedures needed for each sampling, analysis, or measurement
technique. For projects at or beyond the "proof-of-concept" stage and projects employing well-
characterized methods, this section should list each required QC procedure, along with the
associated acceptance criteria and corrective action. Because standard methods are often vague
or incomplete in specifying QC requirements, simply relying on the cited method to provide this
information is usually insufficient. In any case, QC procedures must frequently be modified on a
project-specific basis in order to meet data specifications.
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Identify required measurement QC checks for both the field and the laboratory; for
example, blanks, duplicates, matrix spikes, laboratory control samples, surrogates, or second
column confirmation. State the frequency of analysis for each type of QC check, and the spike
compounds sources and levels. State or reference the required control limits for each QC check
and corrective action required when control limits are exceeded and how the effectiveness of the
corrective action shall be determined and documented.
Describe or reference the procedures to be used to calculate each of the QC statistics,
including the QC checks described in the preceding paragraph as well as precision and bias.
Copies of the formulas are acceptable as long as the accompanying narrative or explanation
specifies clearly how the calculations will address potentially difficult situations such as missing
data values, "less than" or "greater than" values, and other common data qualifiers.
3.3.6 B6 - Instrument/Equipment Testing, Inspection, and Maintenance Requirements
Describe how inspections and acceptance testing of environmental sampling and
measurement systems and their components will be performed and documented to assure their
intended use as specified by the design. Identify and discuss the procedure by which final
acceptance will be performed by independent personnel (e.g., personnel other than those
performing the work) and/or by the EPA project manager. Describe how deficiencies are to be
resolved, when re-inspection will be performed, and how the effectiveness of the corrective
action shall be determined and documented.
Describe or reference how periodic preventive and corrective maintenance of
measurement or test equipment shall be performed to ensure availability and satisfactory
performance of the systems. Identify the equipment and/or systems requiring periodic
maintenance. Discuss how the availability of critical spare parts, identified in the operating
guidance and/or design specifications of the systems, will be assured and maintained.
3.3.7 B7 - Instrument Calibration and Frequency
Identify all tools, gauges, instruments, and other sampling, measuring, and test equipment
used for data collection activities affecting quality that must be controlled and, at specified
periods, calibrated to maintain performance within specified limits. Describe or reference how
calibration will be conducted using certified equipment and/or standards with known valid
relationships to nationally recognized performance standards. If no such nationally recognized
standards exist, document the basis for the calibration. Identify the certified equipment and/or
standards used for calibration. Indicate how records of calibration shall be maintained and be
traceable to the instrument.
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3.3.8 B8 - Inspection/Acceptance Requirements for Supplies and Consumables
Describe how and by whom supplies and consumables (e.g., sample bottles, calibration
gases, reagents, hoses, deionized water, potable water) shall be inspected and accepted for use in
the project. State acceptance criteria for such supplies and consumables.
3.3.9 B9 - Data Acquisition Requirements (Non-direct Measurements)
Identify any types of data needed for project implementation or decision making that are
obtained from non-measurement sources such as computer data bases, programs, literature files,
and historical data bases. Define the acceptance criteria for the use of such data in the project
and discuss any limitations on the use of the data resulting from uncertainty in its quality.
Document the rationale for the original collection of data and indicate its relevance to this
project.
3.3.10 BIO - Data Management
Describe the project data management scheme, tracing the path of the data from their
generation in the field or laboratory to their final use or storage. Describe or reference the
standard record-keeping procedures, document control system, and the approach used for data
storage and retrieval on electronic media. Discuss the control mechanism for detecting and
correcting errors and for preventing loss of data during data reduction, data reporting, and data
entry to forms, reports, and databases. Provide examples of any forms or checklists to be used.
Identify and describe all data handling equipment and procedures to process, compile,
and analyze the data. This includes procedures for addressing data generated as part of the
project as well as data from other sources. Include any required computer hardware and software
and address any specific performance requirements for the hardware/software configuration used.
Describe the procedures that will be followed to demonstrate acceptability of the
hardware/software configuration required.
Describe the process for assuring that applicable Agency information resource
management requirements (EPA Directive 2100) are satisfied. Agency policy requires that
locational data be collected and reported with environmental data. If other Agency data
management requirements are applicable, discuss how these requirements are addressed. Such
requirements may include:
° use of Chemical Abstract Service Registry numbers (EPA Order 2180.1),
» electronic transfer of laboratory data (EPA Order 2180.2), and
° use of minimum data elements for ground water quality (EPA Order 7500.1 A).
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3.4 GROUP C: ASSESSMENT/OVERSIGHT
This group of QAPP elements (Table 3) addresses the activities for assessing the
effectiveness of the implementation of the project and associated QA and QC. The purpose of
assessment is to ensure that the QAPP is implemented as prescribed.
Table 3. Group C: Assessment/Oversight
Elements
Cl
C2
Assessments and Response Actions
Reports to Management
3.4.1 Cl - Assessments and Response Actions
List and describe the assessments to be used in the projec including the frequency and
type of assessment activities needed for this project. Assessments include, but are not limited to
surveillance, management systems reviews, readiness reviews, technical systems audits,
performance evaluations, audit of data qualitys, and data quality assessments. Discuss the
information expected and the success criteria (i.e., goals, performance objectives, acceptance
criteria specifications, etc.) for each assessment proposed. List the approximate schedule of
activities. For any planned self-assessments (utilizing personnel from within the project groups),
identify potential participants and their exact relationship within the project organization. For
independent assessments, identify the organization and person(s) that shall perform the
assessments if this information is available. Describe how and to whom the results of the
assessments shall be reported.
Define the scope of authority of the assessors, including stop work orders. Define
explicitly the unsatisfactory conditions under which the assessors are authorized to act and
provide an approximate schedule for the assessments to be performed.
Discuss how response actions to assessment findings, including corrective actions for
deficiencies and other non-conforming conditions are to be addressed and by whom. Identify
who is responsible for implementing response actions and describe how the response actions are
to be verified and documented.
3.4.2 C2 - Reports to Management
Identify the frequency and distribution of reports issued to inform management of the
status of the project; results of performance evaluations and system audits; results of periodic
data quality assessments; and significant quality assurance problems and recommended
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solutions. Identify the preparer and the recipients of the reports, and the specific actions
management is expected to take as a result of the reports.
3.5 GROUP D: DATA VALIDATION AND USABILITY
This group of QAPP elements (Table 4) covers the QA activities that occur after the data
collection phase of the project is completed. Implementation of these elements determines
whether or not the data conform to the specified criteria, thus satisfying the project objectives.
Table 4. Group D: Data Validation
and Usability
Dl
D2
D3
Data Review, Validation, and Verification
Requirements
Validation and Verification Methods
Reconciliation with User Requirements
3.5.1 Dl - Data Review, Validation, and Verification Requirements
State the criteria used to review and validate - that is, accept, reject, or qualify - data, in
an objective and consistent manner. Provide examples of any forms or checklists to be used.
Identify any project-specific calculations required.
3.5.2 D2 - Validation and Verification Methods
Describe the process to be used for validating and verifying data, including the chain of
custody for data throughout the life cycle of the project or task. Discuss how issues shall be
resolved and the authorities for resolving such issues. Describe how the results are conveyed to
data users. Precisely define and interpret how validation issues differ from verification issues for
this project.
3.5.3 D3 - Reconciliation with User Requirements
Describe how the results obtained from the project or task will be reconciled with the
requirements defined by the data user or decision maker. Outline the proposed methods to
analyze the data and determine possible anomalies or departures from assumptions established in
the planning phase of data collection. Describe how issues will be resolved and discuss how
limitations on the use of the data will be reported to decision makers.
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CHAPTER 4
PQAP ELEMENTS
The Proposal Quality Assurance Plan (PQAP) is a document that encompasses elements
of the Quality Management Plan (QMP) and the more detailed QA Project Plan (QAPP), and
presents these elements in a less formal format, including a narrative. Previously, the PQAP was
called the QA Narrative Statement. Its purpose is to provide information to the EPA project
manager (or award official) on an offerer's or applicant's capabilities to provide sufficient and
adequate QA and QC for proposed work in a shorter, less rigorous document than the QAPP. As
noted earlier, the PQAP may also be applied to small data collection tasks, small assistance
agreements for basic or exploratory research, and similar work of limited scope and duration, that
do not require the level of detail of the QAPP. The decision to accept the PQAP for
environmental data collection work in lieu of the QAPP belongs to the EPA project manager.
When used in a proposal or application evaluation, a full QAPP may be required after an
award is made in order to provide sufficient and adequate detail on the environmental data
collection activities. In the case of the small projects discussed earlier, the PQAP may contain
sufficient detail and may be substituted for the QAPP. Such small projects may include research
assistance agreements (under 40 CFR Part 30), small assistance agreements to states or
municipalities (under 40 CFR Parts 31 and 35), and small tasks in level-of-effort contracts (under
48 CFR Part 46). This decision is made by the EPA project manager (or award official). When
accepted as such, the PQAP becomes the official QAPP for the work.
The use of the PQAP is left flexible deliberately. It is not EPA's intention to arbitrarily
define "small" or "large" projects, or "complex" and "simple" projects. The EPA project
manager, in consultation with the EPA QA Manager, is the best person to decide when to use the
PQAP or the QAPP, because some small projects may be very complex and need extensive QA
and QC documentation while other, larger projects may not need that level of QA and QC
documentation. In general, the options are as follows:
° Assistance Agreements:
use the PQAP with application. A formal, more detailed QAPP may be
required after award, or
require a formal QAPP with the application.
0 Contracts, Work Assignments, Interagency Agreements:
use PQAP with proposals for contracts and interagency agreements. A
formal, more detailed QAPP is required after award,
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use PQAP or QAPP for work assignments, delivery orders, or task orders,
as appropriate and as determined by the Work Assignment Manager.
The PQAP shall include or address:
e a project description, including the purpose of the work (including the hypothesis
to be tested, if appropriate), the data collection activities to be performed, and how
the environmental data produced will be used;
° a statement of the project objectives, including the primary goals, expected level
of confidence in the resulting data, and criteria for successful completion of the
work;
° a description of the sampling and analytical design (experimental design) of the
project, including identification of critical and non-critical aspects of the project,
sampling and analytical method to be used, calibration requirements for
instruments (as appropriate), and relevant method performance criteria;
° a description of the process for the handling and custody of samples, including
sample identification, preservation, transportation, storage, and final disposal;
° a listing of the proposed start and ending dates for the project with key milestones
and interim deliverables, as appropriate, identified;
° a listing of the key project staff and their roles and responsibilities;
0 a description of how quality will be assured during the project, including the use
of performance evaluations, audits, surveillance, and other assessment procedures;
procedures for data validation and verification (including statistical analyses
used), and the how corrective actions will be implemented and their effectiveness
confirmed; and
° identification of any needed special reports on the QA and QC activities
performed, as appropriate.
In conclusion, the PQAP may an acceptable choice of QA and QC planning
documentation for small projects. The PQAP may also be used when both the organizational
capabilities of the offeror/applicant relative to QA and QC and some project-specific details are
key to the successful performance of the work. In all cases, either the PQAP or QAPP must be
used.
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REFERENCES
Title 40, Part 30, Code of Federal Regulations, "Grants and Agreements With Institutions of
Higher Education, Hospitals, and Other Non-Profit Organizations."
Title 40, Part 31, Code of Federal Regulations, "Uniform Administrative Requirements for
Grants and Cooperative Agreement to State and Local Governments."
Title 40, Part 35, Code of Federal Regulations, "State and Local Assistance."
Title 48, CFR, Part 46, Code of Federal Regulations, "Federal Acquisition Regulations."
ANSI/ASQC E4-1994, Specifications and Guidelines for Quality Systems for Environmental
Data Collection and Environmental Technology Programs, American National Standard,
January 1995.
EPA Directive 2100 (1998), Information Resources Management Policy Manual, U.S.
Environmental Protection Agency, Washington, DC.
EPA Directive 2182 (December 1996), EPA System Design and Development Guidance, U.S.
Environmental Protection Agency, Washington, DC.
EPA Order 2180.1 (June 1987), Chemical Abstract Service Registry Number Data Standard,
U.S. Environmental Protection Agency, Washington, DC.
EPA Order 2180.2 (December 1998), Data Standards for the Electronic Transmission of
Laboratory Measurement Results, U.S. Environmental Protection Agency, Washington,
DC.
EPA Order 5360, July 1998. EPA Quality Manual for Environmental Programs, U.S.
Environmental Protection Agency, Washington, DC.
EPA Order 5360.1 CHG 1 (July 1998), Policy and Program Requirements to Implement the
Mandatory Quality Assurance Program, U.S. Environmental Protection Agency,
Washington, DC.
EPA Order 7500.1 A (October 1992), Minimum Set of Data Elements for Ground-Water Quality,
U.S. Environmental Protection Agency, Washington, DC.
ISO 8402-1994, Quality Management and Quality Assurance - Vocabulary (April 1994).
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U.S. Environmental Protection Agency, 1998a. EPA Requirements for Quality Management
Plans (QA/R-2), EPA/600/R-98/???, Office of Research and Development.
U.S. Environmental Protection Agency, 1998b. Guidance for Data Quality Assessment:
Practical Methods for Data Analysis (QA/G-9), EPA/600/R-96/084, Office of Research
and Development.
U.S. Environmental Protection Agency, 1998c. Guidance for Quality Assurance Project Plans
(QA/G-5), EPA/600/R-98/018, Office of Research and Development.
U.S. Environmental Protection Agency, 1996. Guidance for the Preparation of Standard
Operating Procedures (SOPs)for Quality-Related Documents (QA/G-6), EPA/600/R-
96/027, Office of Research and Development.
U.S. Environmental Protection Agency, 1994. Guidance for the Data Quality Objectives
Process (QA/G-4), EPA/600/R-96/055, Office of Research and Development.
U.S. Environmental Protection Agency, 1980. Interim Guidelines and Specifications for
Preparing Quality Assurance Project Plans, QAMS-005/80, Office of Research and
Development.
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APPENDIX A
CROSSWALKS AMONG QUALITY ASSURANCE DOCUMENTS
A.I BACKGROUND
This appendix contains crosswalks between this document and other QA planning
documents. The first crosswalk compares this requirements document with its predecessor
document, QAMS 005/80, Interim Guidelines and Specifications for Preparing Quality
Assurance Project Plans (EPA 1980). The second crosswalk compares the elements of the
QAPP defined in this document with the steps defined in Guidance for the Data Quality
Objectives Process (QA/G-4) (EPA 1994), the Agency's preferred systematic planning process
for environmental decision making. This crosswalk is provided to assist the reader in
determining how the outputs from the DQO Process can be integrated into a QAPP
A.2 CROSSWALK BETWEEN EPA QA/R-5 AND QAMS-005/80
QAMS-005/80 -ELEMENTS
1.0
2.0
3.0
4.0
5.0
6.0
7.0
Title Page with Provision for
Approval Signatures
Table of Contents
Project Description
Project Organization and
Responsibility
QA Objectives for Measurement
Data (PARCC)
Sampling Procedures
Sample Custody
QA/R-5 ELEMENTS - "' J^ %: ';;
Al
A2
A5
A6
A4
A9
A7
Bl
B2
A8
B3
Title and Approval Sheet
Table of Contents
Problem Definition/Background
Project/Task Description
Project/Task Organization
Documentation and Records
Quality Objectives and Criteria for
Measurement Data
Sampling Process Design
Sampling Methods Requirements
Special Training Requirements/
Certification
Sample Handling and Custody
Requirements
EPA QA/R-5
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A.2 CROSSWALK BETWEEN EPA QA/R-5 AND QAMS-005/80
QAMS-005/80 ELEMENTS
8.0 Calibration Procedures and
Frequency
9.0 Analytical Procedures
10.0 Data Reduction, Validation, and
Reporting
1 1 .0 Internal Quality Control Checks
and Frequency
12.0 Performance and Systems
13.0 Preventive Maintenance
14.0 Specific Routine Procedures
Measurement Parameters
Involved
15.0 Corrective Action
16.0 QA Reports to Management
QA/R-5 ELEMENTS
B7
B4
Dl
D2
B9
BIO
B5
Cl
B6
B8
D3
Cl
A3
C2
Instrument Calibration and Frequency
Analytical Methods Requirements
Data Review, Validation, and
Verification Requirements
Validation and Verification Methods
Data Acquisition Requirements
Data Management
Quality Control Requirements
Assessments and Response Actions
Instrument/Equipment Testing,
Inspection, and Maintenance
Requirements
Inspection/ Acceptance Requirements
for Supplies and Consumables
Reconciliation with User
Requirements
Assessments and Response Actions
Distribution List
Reports to Management
EPA QA/R-5
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A.3 CROSSWALK BETWEEN THE DQO PROCESS AND THE QAPP
Elements
Requirements
DQO Overlap
PROJECT MANAGEMENT
Al Title and Approval Sheet
A2 Table of Contents
A3 Distribution List
A4 Project/Task
Organization
A5 Problem Definition/
Background
A6 Project/Task Description
A7 Quality Objectives and
Criteria for Measurement
Data
A8 Special Training
Requirements/
Certification
A9 Documentation and
Records
Title and approval sheet.
Document control format.
Distribution list for the QAPP revisions and final guidance.
Identify individuals or organizations participating in the project and discuss
their roles, responsibilities and organization.
1) State the specific problem to be solved or the decision to be made.
2) Identify the decision maker and the principal customer for the results.
1) Hypothesis test, 2) expected measurements, 3) ARARs or other
appropriate standards, 4) assessment tools (technical audits), 5) work
schedule and required reports.
Decision(s), population parameter of interest, action level, summary
statistics and acceptable limits on decision errors. Also, scope of the
project (domain or geographical locale).
Identify special training that personnel will need.
Itemize the information and records that must be included in a data report
package, including report format and requirements for storage, etc.
N/A
N/A
Step 1: State the Problem
Step 1: State the Problem
Step 1: State the Problem
Step 2: Identify the Decision
Step 1: State the Problem
Step 2: Identify the Decision
Step 3: Identify the Inputs
Step 6: Specify Limits on Decision Errors
Step 4: Define the Boundaries
Step 5: Develop a Decision Rule
Step 6: Specify Limits on Decision Errors
Step 3: Identify the Inputs to the Decision
Step 3: Identify the Inputs to the Decision
Step 7: Optimize the Design for Obtaining Data
MEASUREMENT/DATA ACQUISITION
B 1 Sampling Process Design
(Experimental Design)
B2 Sampling Methods
Requirements
B3 Sample Handling and
Custody Requirements
B4 Analytical Methods
Requirements
Outline the experimental design, including sampling design and rationale,
sampling frequencies, matrices, and measurement parameter of interest.
Sample collection method and approach.
Describe the provisions for sample labeling, shipment, chain-of-custody
forms, procedures for transferring and maintaining custody of samples.
Identify analytical method(s) and equipment for the study, including
method performance requirements.
Step 7: Optimize the Design for Obtaining Data
Step 5: Develop a Decision Rule.
Step 7: Optimize the Design for Obtaining Data
Step 3: Identify the Inputs to the Decision
Step 3: Identify the Inputs to the Decision
Step 7: Optimize the Design for Obtaining Data
EPA QA/R-5
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External Review
October 1998
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A.3 CROSSWALK BETWEEN THE DQO PROCESS AND THE QAPP
Elements
B5 Quality Control
Requirements
B6 Instrument/Equipment
Testing, Inspection, and
Maintenance Reqs.
B7 Instrument Calibration
and Frequency
B8 Inspection/ Acceptance
Requirements for
Supplies and
Consumables
B9 Data Acquisition
Requirements (Non-
direct Measurements)
BIO Data Management
Requirements
Describe routine (real-time) QC procedures that should be associated with
each sampling and measurement technique. List required QC checks and
corrective action procedures.
Discuss how inspection and acceptance testing, including the use of QC
samples, must be performed to ensure their intended use as specified by the
design.
Identify tools, gauges and instruments, and other sampling or measurement
devices that need calibration. Describe how the calibration should be done.
Define how and by whom the sampling supplies and other consumables
will be accepted for use in the project.
Define the criteria for the use of non- measurement data such as data that
come from databases or literature.
Outline the data management scheme including the path and storage of the
data and the data record-keeping system. Identify all data handling
equipment and procedures that will be used to process, compile, and
analyze the data.
DQO Overlap
Step 3: Identify the Inputs to the Decision
Step 3: Identify the Inputs to the Decision
Step 3: Identify the Inputs to the Decision
N/A
Step 1: State the Problem
Step 7: Optimize the Design for Obtaining Data
Step 3: Identify the Inputs to the Decision
Step 7: Optimize the Design for Obtaining Data
ASSESSMENT/OVERSIGHT
Cl Assessments and
Response Actions
C2 Reports to Management
Describe the assessment activities needed for this project. These may
include DQA, PE, TSA, MSR/ PR/RR
Identify the frequency, content and distribution of reports issued to keep
management informed.
Step 5: Develop a Decision Rule
Step 6: Specify Limits on Decision Errors
N/A
DATA VALIDATION AND USABILITY
Dl Data Review, Validation,
and Verification
Requirements
D2 Validation and
Verification Reqs.
D3 Reconciliation With User
Reauirements
State the criteria used to accept or reject the data based on quality.
Describe the process to be used for validating and verifying data, including
the chain-of-custody for data throughout the lifetime of the project.
Describe how results will be evaluated to determine if performance criteria
have been satisfied.
Step 7: Optimize the Design for Obtaining Data
Step 3: Identify the Inputs to the Decision
Step 7: Optimize the Design for Obtaining Data
EPA QA/R-5
A-4
External Review
October 1998
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APPENDIX B
TERMS AND DEFINITIONS
activity - an all-inclusive term describing a specific set of operations or related tasks to be
performed, either serially or in parallel (e.g., research and development, field sampling,
analytical operations, equipment fabrication), that in total result in a product or service.
assessment - the evaluation process used to measure the performance or effectiveness of a
system and its elements. As used here, assessment is an all-inclusive term used to denote any of
the following: audit, performance evaluation, management systems review, peer review,
inspection, or surveillance.
audit (quality) - a systematic and independent examination to determine whether quality
activities and related results comply with planned arrangements and whether these arrangements
are implemented effectively and are suitable to achieve objectives.
bias - the systematic or persistent distortion of a measurement process which causes errors in one
direction (i.e., the expected sample measurement is different from the sample's true value).
calibration - comparison of a measurement standard, instrument, or item with a standard or
instrument of higher accuracy to detect and quantify inaccuracies and to report or eliminate those
inaccuracies by adjustments.
chain of custody - an unbroken trail of accountability that ensures the physical security of
samples, data, and records.
completeness - a measure of the amount of valid data obtained from a measurement system
compared to the amount that was expected to be obtained under correct, normal conditions.
configuration - the functional, physical, and procedural characteristics of an item, experiment, or
document.
contractor - any organization or individual that contracts to furnish services or items or perform
work.
client - any individual or organization for whom items or services are furnished or work
performed in response to defined requirements and expectations.
data quality assessment - a statistical and scientific evaluation of the data set to determine the
validity and performance of the data collection design and statistical test, and to determine the
adequacy of the data set for its intended use.
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data quality objectives process - a systematic planning tool to facilitate the planning of
environmental data collection activities.
data usability - the process of ensuring or determining whether the quality of the data produced
meets the intended use of the data.
design - specifications, drawings, design criteria, and performance requirements. Also the result
of deliberate planning, analysis, mathematical manipulations, and design processes.
entity - that which can be individually described and considered, such as a process, product,
item, organization, or combination thereof.
environmental conditions - the description of a physical medium (e.g., air, water, soil,
sediment) or biological system expressed in terms of its physical, chemical, radiological, or
biological characteristics.
environmental data - any measurements or information that describe environmental processes,
location, or conditions; ecological or health effects and consequences; or the performance of
environmental technology. For EPA, environmental data include information collected directly
from measurements, produced from models, and compiled from other sources such as data bases
or the literature.
environmental data operations - work performed to obtain, use, or report information
pertaining to environmental processes and conditions.
environmental monitoring - the process of measuring or collecting environmental data.
environmental processes - manufactured or natural processes that produce discharges to or that
impact the ambient environment.
environmental programs - work or activities involving the environment, including but not
limited to: characterization of environmental processes and conditions; environmental
monitoring; environmental research and development; the design, construction, and operation of
environmental technologies; and laboratory operations on environmental samples.
environmental technology - an all-inclusive term used to describe pollution control devices and
systems, waste treatment processes and storage facilities, and site remediation technologies and
their components that may be utilized to remove pollutants or contaminants from or prevent them
from entering the environment. Examples include wet scrubbers (air), soil washing (soil),
granulated activated carbon unit (water), and filtration (air, water). Usually, this term will apply
to hardware-based systems; however, it will also apply to methods or techniques used for
pollution prevention, pollutant reduction, or containment of contamination to prevent further
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movement of the contaminants, such as capping, solidification or vitrification, and biological
treatment.
EPA project manager - the responsible EPA official for the project and includes such
descriptors as Project Officer, Delivery Order Project Officer, Work Assignment Manager, and
Principal Investigator.
extramural agreement - a legal agreement between EPA and an organization outside EPA for
items or services to be provided. Such agreements include contracts, work assignments, delivery
orders, task orders, cooperative agreements, research grants, state and local grants, and EPA-
funded interagency agreements.
financial assistance - the process by which funds are provided by one organization (usually
government) to another organization for the purpose of performing work or furnishing services or
items. Financial assistance mechanisms include grants, cooperative agreements, and government
interagency agreements.
graded approach - the process of basing the level of application of managerial controls applied
to an item or work according to the intended use of the results and the degree of confidence
needed in the quality of the results.
guideline - a suggested practice that is non-mandatory in programs intended to comply with a
standard.
hazardous waste - any waste material that satisfies the definition of "hazardous waste" as given
in 40 CFR Part 261, "Identification and Listing of Hazardous Waste."
independent assessment - an assessment performed by a qualified individual, group, or
organization that is not a part of the organization directly performing and accountable for the
work being assessed.
inspection - examination or measurement of an item or activity to verify conformance to specific
requirements.
item - an all-inclusive term used in place of the following: appurtenance, facility, sample,
assembly, component, equipment, material, module, part, product, structure, subassembly,
subsystem, system, unit, documented concepts, or data.
management - those individuals directly responsible and accountable for planning,
implementing, and assessing work.
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management system - a structured non-technical system describing the policies, objectives,
principles, organizational authority, responsibilities, accountability, and implementation plan of
an organization for conducting work and producing items and services.
management systems review (MSR) - the qualitative assessment of a data collection operation
and/or organization(s) to establish whether the prevailing quality management structure, policies,
practices, and procedures are adequate for ensuring that the type and quality of data needed are
obtained.
measurement and testing equipment - tools, gauges, instruments, sampling devices or systems
used to calibrate, measure, test, or inspect in order to control or acquire data to verify
conformance to specified requirements.
method - a body of procedures and techniques for performing an activity (e.g., sampling,
chemical analysis, quantification) systematically presented in the order in which they are to be
executed.
objective evidence - any documented statement of fact, other information, or record, either
quantitative or qualitative, pertaining to the quality of an item or activity, based on observations,
measurements, or tests which can be verified.
organization - a company, corporation, firm, enterprise, or institution, or part thereof, whether
incorporated or not, public or private, that has its own functions and administration.
participant - when used in the context of environmental programs, an organization, group, or
individual that takes part in the planning and design process and provides special knowledge or
skills to enable the planning and design process to meet its objective.
peer review - a documented critical review of work by qualified individuals (or organizations)
who are independent of those who performed the work, but are collectively equivalent in
technical expertise. A peer review is conducted to ensure that activities are technically adequate,
competently performed, properly documented, and satisfy established technical and quality
requirements. The peer review is an in-depth assessment of the assumptions, calculations,
extrapolations, alternate interpretations, methodology, acceptance criteria, and conclusions
pertaining to specific work and of the documentation that supports them.
performance evaluation - a type of audit in which the quantitative data generated in a
measurement system are obtained independently and compared with routinely obtained data to
evaluate the proficiency of an analyst or laboratory.
External Review
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precision - a measure of mutual agreement among individual measurements of the same
property, usually under prescribed similar conditions, expressed generally in terms of the
standard deviation.
process - a set of interrelated resources and activities which transforms inputs into outputs.
Examples of processes include analysis, design, data collection, operation, fabrication, and
calculation.
quality - the totality of features and characteristics of a product or service that bear on its ability
to meet the stated or implied needs and expectations of the user.
quality assurance (QA) - an integrated system of management activities involving planning,
implementation, documentation, assessment, reporting, and quality improvement to ensure that a
process, item, or service is of the type and quality needed and expected by the client.
quality assurance manager (QAM) - the individual designated as the principal manager within
the organization having management oversight and responsibilities for planning, documenting,
coordinating, and assessing the effectiveness of the quality system for the organization.
quality assurance project plan (QAPP) - a document describing in comprehensive detail the
necessary QA, QC, and other technical activities that must be implemented to ensure that the
results of the work performed will satisfy the stated performance criteria.
quality control (QC) - the overall system of technical activities that measures the attributes and
performance of a process, item, or service against defined standards to verify that they meet the
stated requirements established by the customer; operational techniques and activities that are
used to fulfill requirements for quality.
quality improvement - a management program for improving the quality of operations. Such
management programs generally entail a formal mechanism for encouraging worker
recommendations with timely management evaluation and feedback or implementation.
quality management - that aspect of the overall management system of the organization that
determines and implements the quality policy. Quality management includes strategic planning,
allocation of resources, and other systematic activities (e.g., planning, implementation,
documentation, and assessment) pertaining to the quality system.
quality management plan (QMP) - a document that describes the quality system in terms of the
organizational structure, functional responsibilities of management and staff, lines of authority,
and required interfaces for those planning, implementing, and assessing all activities conducted.
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quality system - a structured and documented management system describing the policies,
objectives, principles, organizational authority, responsibilities, accountability, and
implementation plan of an organization for ensuring quality in its work processes, products
(items), and services. The quality system provides the framework for planning, implementing,
documenting, and assessing work performed by the organization and for carrying out required
QA and QC.
readiness review - a systematic, documented review of the readiness for the start-up or
continued use of a facility, process, or activity. Readiness reviews are typically conducted before
proceeding beyond project milestones and prior to initiation of a major phase of work.
record - a completed document that provides objective evidence of an item or process. Records
may include photographs, drawings, magnetic tape, and other data recording media.
research (applied) - a process, the objective of which is to gain knowledge or understanding
necessary for determining the means by which a recognized and specific need may be met.
research (basic) - a process, the objective of which is to gain fuller knowledge or understanding
of the fundamental aspects of phenomena and of observable facts without specific applications
toward processes or products in mind.
research development/demonstration - systematic use of the knowledge and understanding
gained from research and directed toward the production of useful materials, devices, systems, or
methods, including prototypes and processes.
self-assessment - assessment of work conducted by individuals, groups, or organizations directly
responsible for overseeing and/or performing the work.
service - the result generated by activities at the interface between the supplier and the customer,
and by supplier internal activities to meet customer needs. Such activities in environmental
programs include design, inspection, laboratory and/or field analysis, repair, and installation.
specification - a document stating requirements and which refers to or includes drawings or
other relevant documents. Specifications should indicate the means and the criteria for
determining conformance.
standard operating procedure (SOP) - a written document that details the method for an
operation, analysis, or action with thoroughly prescribed techniques and steps, and that is
officially approved as the method for performing certain routine or repetitive tasks.
supplier - any individual or organization furnishing items or services or performing work
according to a procurement document or financial assistance agreement. This is an all-inclusive
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term used in place of any of the following: vendor, seller, contractor, subcontractor, fabricator, or
consultant.
surveillance (quality) - continual or frequent monitoring and verification of the status of an
entity and the analysis of records to ensure that specified requirements are being fulfilled.
technical review - a documented critical review of work that has been performed within the state
of the art. The review is accomplished by one or more qualified reviewers who are independent
of those who performed the work, but are collectively equivalent in technical expertise to those
who performed the original work. The review is an in-depth analysis and evaluation of
documents, activities, material, data, or items that require technical verification or validation for
applicability, correctness, adequacy, completeness, and assurance that established requirements
are satisfied.
technical systems audit (TSA) - a thorough, systematic, on-site, qualitative audit of facilities,
equipment, personnel, training, procedures, record keeping, data validation, data management,
and reporting aspects of a system.
user - an organization, group, or individual that utilizes the results or products from
environmental programs or a customer for whom the results or products were collected or
created.
validation - confirmation by examination and provision of objective evidence that the particular
requirements for a specific intended use are fulfilled. In design and development, validation
concerns the process of examining a product or result to determine conformance to user needs.
verification - confirmation by examination and provision of objective evidence that specified
requirements have been fulfilled. In design and development, validation concerns the process of
examining a result of a given activity to determine conformance to the stated requirements for
that activity.
External Review
EPA QA/R-5 B-7 October 1998
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