United States
Environmental Protection
Agency
Office of Environmental
Information
Washington, DC 20460
EPA/240/B-01/003
March 2001
&EPA EPA Requirements for Quality
Assurance Project Plans
EPA QA/R-5
-------
-------
FOREWORD
The U.S. Environmental Protection Agency (EPA) has developed the Quality Assurance
Project Plan (QA Project Plan) as a tool for project managers and planners to document the type
and quality of data needed for environmental decisions and to describe the methods for collecting
and assessing those data. The development, review, approval, and implementation of the QA
Project Plan is part of EPA's mandatory Quality System. The EPA Quality System requires all
organizations to develop and operate management structures and processes to ensure that data
used in Agency decisions are of the type and quality needed for their intended use. The QA
Project Plan is an integral part of the fundamental principles and practices that form the
foundation of the EPA Quality System.
This document provides the QA Project Plan requirements for organizations that conduct
environmental data operations on behalf of EPA through contracts, financial assistance
agreements, and interagency agreements; however, it may be used by EPA as well. It contains the
same requirements as Chapter 5 of EPA Order 5360 A1 (EPA 2000), The EPA Quality Manual
for Environmental Programs., which has been developed for internal use by EPA organizations.
A companion document, EPA Guidance for Quality Assurance Project Plans (QA/G-5) (EPA
1998) provides suggestions for both EPA and non-EPA organizations on preparing, reviewing,
and implementing QA Project Plans that satisfy the requirements defined in this document.
This document is one of the EPA Quality System Series documents which describe EPA
policies and procedures for planning, implementing, and assessing the effectiveness of a quality
system. Questions regarding this document or other EPA Quality System Series documents
should be directed to:
U.S. EPA
Quality Staff (2811R)
Washington, DC 20460
Phone: (202) 564-6830
FAX: (202)565-2441
e-mail: quality@epa.gov
Copies of Quality System Series documents may be obtained from the Quality Staff or by
downloading them from the Quality Staff Home Page:
www.epa.gov/quality
Final
EPAQA/R-5 i March 2001
-------
ACKNOWLEDGMENTS
This document reflects the collaborative efforts of many quality management professionals
who participate in the challenge for continual improvement in quality systems supporting
environmental programs. These individuals, representing the EPA, other Federal agencies, State
and local governments, and private industry, reflect a diverse and broad range of needs and
experiences in environmental data collection programs. Their contributions and the
comprehensive reviews during the development of this document are greatly appreciated.
Final
EPAQA/R-5 ii March 2001
-------
TABLE OF CONTENTS
Page
CHAPTER 1. INTRODUCTION 1
1.1 BACKGROUND 1
1.2 QA PROJECT PLANS, THE EPA QUALITY SYSTEM, AND
ANSI/ASQC E4-1994 2
1.3 THE GRADED APPROACH AND THE EPA QUALITY SYSTEM 4
1.4 INTENDED AUDIENCE 4
1.5 PERIOD OF APPLICABILITY 4
1.6 ADDITIONAL RESOURCES 4
1.7 SUPERSESSION 5
CHAPTER 2. QA PROJECT PLAN REQUIREMENTS 7
2.1 POLICY 7
2.2 PURPOSE 7
2.3 APPLICABILITY 7
2.4 GENERAL CONTENT AND DETAIL REQUIREMENTS 7
2.4.1 General Content 7
2.4.2 Level of Detail 8
2.5 QA PROJECT PLAN PREPARATION AND APPROVAL 8
2.6 QA PROJECT PLAN IMPLEMENTATION 9
2.7 QA PROJECT PLAN REVISION 9
CHAPTER 3. QA PROJECT PLAN ELEMENTS 11
3.1 CONTENT REQUIREMENTS 11
3.2 GROUP A: PROJECT MANAGEMENT 12
3.2.1 Al - Title and Approval Sheet 13
3.2.2 A2 - Table of Contents 13
3.2.3 A3 - Distribution List 14
3.2.4 A4 - Project/Task Organization 14
3.2.5 A5 - Problem Definition/Background 14
3.2.6 A6 - Project/Task Description 14
3.2.7 A7 - Quality Objectives and Criteria 15
3.2.8 A8 - Special Training/Certification 15
3.2.9 A9 - Documents and Records 15
3.3 GROUP B: DATA GENERATION AND ACQUISITION 15
3.3.1 Bl- Sampling Process Design (Experimental Design) 16
3.3.2 B2 - Sampling Methods 17
3.3.3 B3 - Sample Handling and Custody 17
3.3.4 B4 - Analytical Methods 17
3.3.5 B5 - Quality Control 18
Final
EPAQA/R-5 iii March 2001
-------
Page
3.3.6 B6 - Instrument/Equipment Testing, Inspection, and Maintenance 18
3.3.7 B7 - Instrument/Equipment Calibration and Frequency 18
3.3.8 B8 - Inspection/Acceptance of Supplies and Consumables 19
3.3.9 B9 - Non-direct Measurements 19
3.3.10 BIO -DataManagement 19
3.4 GROUP C: ASSESSMENT AND OVERSIGHT 20
3.4.1 Cl - Assessments and Response Actions 20
3.4.2 C2 - Reports to Management 20
3.5 GROUP D: DATA VALIDATION AND USABILITY 21
3.5.1 Dl - Data Review, Verification, and Validation 21
3.5.2 D2 - Verification and Validation Methods 21
3.5.3 D3 - Reconciliation with User Requirements 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 QA PROJECT PLAN A-3
APPENDIX B. TERMS AND DEFINITIONS B-l
FIGURES
Page
1. EPA Quality System Components and Tools 3
2. Example Document Control Format 14
TABLES
Page
1. Group A: Project Management Elements 13
2. Group B: Data Generation and Acquisition Elements 16
3. Group C: Assessment and Oversight Elements 20
4. Group D: Data Validation and Usability Elements 21
Final
EPA QA/R-5 iv March 2001
-------
CHAPTER 1
INTRODUCTION
1.1 BACKGROUND
Environmental programs conducted by or funded by the U.S. Environmental Protection
Agency (EPA) involve many diverse activities that address complex environmental issues. The
EPA annually spends several hundred million dollars in the collection of environmental data for
scientific research and regulatory decision making. In addition, non-EPA organizations may
spend as much as an order of magnitude more each year to respond to Agency requirements. If
decision makers (EPA and otherwise) are to have confidence in the quality of environmental data
used to support their decisions, there must be a structured process for quality in place.
A structured system that describes the policies and procedures for ensuring that work
processes, products, or services satisfy stated expectations or specifications is called a quality
system. All organizations conducting environmental programs funded by EPA are required to
establish and implement a quality system. EPA also requires that all environmental data used in
decision making be supported by an approved Quality Assurance Project Plan (QA Project Plan).
This requirement is defined in EPA Order 5360.1 A2 (EPA 2000), Policy and Program
Requirements for the Mandatory Agency-wide Quality System, for EPA organizations. Non-EPA
organizations funded by EPA are required to develop a QA Project Plan through:
48 CFR 46, for contractors;
40 CFR 30, 31, and 35 for assistance agreement recipients; and
• other mechanisms, such as consent agreements in enforcement actions.
The QA Project Plan integrates all technical and quality aspects of a project, including
planning, implementation, and assessment. The purpose of the QA Project Plan 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
QA Project Plan documents how quality assurance (QA) and quality control (QC) are applied to
an 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 QA Project Plan and its effective implementation. Stakeholders (i.e., the data
users, data producers, decision makers, etc.) shall be involved in the planning process for a
program or project to ensure that their needs are defined adequately and addressed. While time
spent on such planning may seem unproductive and costly, the penalty for ineffective planning
Final
EPAQA/R-5 1 March 2001
-------
includes greater cost and lost time. Therefore, EPA requires that a systematic planning process be
used to plan all environmental data operations. To support this requirement, EPA has developed
a process called the Data Quality Objectives (DQO) Process. The DQO Process is the Agency's
preferred planning process and is described in the Guidance for the Data Quality Objectives
Process (QA/G-4) (EPA 2000b). The QA Project Plan documents the outputs from systematic
planning.
This requirements document presents specifications and instructions for the information
that must be contained in a QA Project Plan for environmental data operations funded by EPA.
The document also discusses the procedures for review, approval, implementation, and revision of
QA Project Plans. Users of this document should assume that all of the elements described herein
are required in a QA Project Plan unless otherwise directed by EPA.
1.2 QA PROJECT PLANS, THE EPA QUALITY SYSTEM, AND ANSI/ASQC
E4-1994
EPA Order 5360.1 A2 and the applicable Federal regulations (defined above) establish a
mandatory Quality System that applies to all EPA organizations and organizations funded by
EPA. Components of the EPA Quality System are illustrated in Figure 1. 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 QA Project Plan is a
key project-level component of the EPA Quality System.
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 standard describes the necessary management
and technical elements for developing and implementing a quality system. This standard
recommends using a tiered approach to a quality system. This standard recommends first
documenting each organization-wide quality system in a Quality Management Plan or Quality
Manual (to address requirements of Part A: Management Systems of the standard) and then
documenting the applicability of the quality system to technical activity-specific efforts in a QA
Project Plan or similar document (to address the requirements of Part B: Collection and
Evaluation of Environmental Data of the standard). EPA has adopted this tiered approach for its
mandatory Agency-wide Quality System. This document addresses Part B requirements of the
standard.
A Quality Management Plan, or equivalent Quality Manual, 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 Quality Management Plan may be viewed as the "umbrella" document
under which individual projects are conducted. EPA requirements for Quality Management Plans
are defined inEPA Requirements for Quality Management Plans (QA/R-2) (EPA 2001). The
Final
EPAQA/R-5 2 March 2001
-------
O
LLJ
O
o
o
Q.
z
g
i
z
o
o
O
_l
O
Q.
Consensus Standards
ANSI/ASQC E4
ISO 9000 Series
Internal EPA Policies
EPA Order 5360.1
EPA Manual 5360
External Policies
Contracts - 48 CFR 46
Assistance Agreements -
40 CFR 30, 31, and 35^
EPA Program &
Regional Policy
Supporting System Elements
(e.g., Procurements,
Computer Hardware/Software)
Training/Communication
(e.g., Training Plan,
Conferences)
Systematic
Planning
(e.g., DQO Process)
-------
Quality Management Plan is then supported by project-specific QA Project Plans. In some cases,
a QA Project Plan and a Quality Management Plan may be combined into a single document that
contains both organizational and project-specific elements. The QA Manager for the EPA
organization sponsoring the work has the authority to determine when a single document is
applicable and will define the content requirements of such a document.
1.3 THE GRADED APPROACH AND THE EPA QUALITY SYSTEM
Recognizing that a "one size fits all" approach to quality requirements will not work in
organizations as diverse as EPA, implementation of the EPA Quality System is based on the
principle of graded approach. Applying a graded approach means that quality systems for
different organizations and programs will vary according to the specific objectives and needs of
the organization. For example, the quality expectations of a fundamental research program are
different from that of a regulatory compliance program because the purpose or intended use of the
data is different. The specific application of the graded approach principle to QA Project Plans is
described in Section 2.4.2.
1.4 INTENDED AUDIENCE
This document specifies the requirements for developing QA Project Plans for
organizations that conduct environmental data operations funded by EPA through contracts,
financial assistance agreements, and interagency agreements. EPA organizations may also use this
document to develop QA Project Plans since this document is clearer and more user-friendly than
the equivalent requirements defined in Section 5.3 of EPA Order 5360 Al (EPA 2000), The EPA
Quality Manual for Environmental Programs (an internal policy document). However, the
preparation, submission, review, and approval requirements for EPA organizations are still
contained in Section 5.2 of EPA Order 5360 Al as these represent internal EPA policy.
1.5 PERIOD OF APPLICABILITY
This document shall be valid for a period of up to five years from the official date of
publication. After five years, it shall either be reissued without change, revised, or withdrawn
from the EPA Quality System.
1.6 ADDITIONAL RESOURCES
Guidance on preparing QA Project Plans may be found in a companion document, EPA
Guidance for Quality Assurance Project Plans (QA/G-5) (EPA 1998). This guidance discusses
the application of the QA Project Plan requirements and provides examples. Other documents
that provide guidance on activities critical to successful environmental data operations and
complement the QA Project Plan preparation effort include:
Final
EPAQA/R-5 4 March 2001
-------
Guidance for the Data Quality Objectives Process (QA/G-4), (EPA 2000b)
• Guidance for the Preparation of Standard Operating Procedures for Quality-
Related Documents (QA/G-6), (EPA 1995)
• Guidance for Data Quality Assessment: Practical Me thods for Data Analysis
(QA/G-9), (EPA 2000a)
1.7 SUPERSESSION
This document replaces QAMS-005/80, Interim Guidelines and Specifications for
Preparing Quality Assurance Project Plans (EPA 1980) in its entirety.
Final
EPAQA/R-5 5 March 2001
-------
(This page is intentionally blank.)
Final
EPAQA/R-5 6 March 2001
-------
CHAPTER 2
QA PROJECT PLAN REQUIREMENTS
2.1 POLICY
All work 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 QA
Project Plan. The QA Project Plan will be developed using a systematic planning process based
on the graded approach. No work covered by this requirement shall be implemented without an
approved QA Project Plan 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.
2.2 PURPOSE
The QA Project Plan documents the planning, implementation, and assessment procedures
of, and how specific QA and QC activities will be applied during a particular project. The QA
Project Plan demonstrates conformance to Part B requirements of ANSI/ASQC E4-1994.
2.3 APPLICABILITY
These requirements apply to all environmental programs funded by EPA that acquire,
generate, or compile environmental data including work performed through contracts, work
assignments, delivery orders, task orders, cooperative agreements, interagency agreements, State-
EPA agreements, State, local and Tribal Financial Assistance/Grants, Research Grants, and in
response to statutory or regulatory requirements and consent agreements. These requirements are
negotiated into interagency agreements, including sub-agreements, and, in some cases, are
included in enforcement settlement and consent agreements and orders. Where specific Federal
regulations require the application of QA and QC activities (see Section 1.1), QA Proj ect Plans
shall be prepared, reviewed, and approved in accordance with the specifications contained in this
document unless explicitly superseded by the regulation.
2.4 GENERAL CONTENT AND DETAIL REQUIREMENTS
2.4.1 General Content
The QA Project Plan must be composed of standardized, recognizable elements covering
the entire project from planning, through implementation, to assessment. Chapter 3 of this
document describes specific elements to address for QA Project Plans submitted to EPA. In some
cases, it may be necessary to add special requirements to the QA Project Plan. The EPA
organization sponsoring the work has the authority to define any special requirements beyond
Final
EPAQA/R-5 7 March 2001
-------
those listed in this document. If no additional requirements are specified, the QA Project Plan
shall address all required elements. Each EPA organization defines their organizational-specific
requirements for QA Project Plan documentation in their Quality Management Plan. All
applicable elements defined by the EPA organization sponsoring the work must be addressed.
While most QA Project Plans will describe project- or task-specific activities, there may be
occasions when a generic QA Project Plan may be more appropriate. A generic QA Project Plan
addresses the general, common activities of a program that are to be conducted at multiple
locations or over a long period of time; for example, it may be useful for a large monitoring
program that uses the same methodology at different locations. A generic QA Project Plan
describes, in a single document, the information that is not site or time-specific but applies
throughout the program. Application-specific information is then added to the approved QA
Project Plan as that information becomes known or completely defined. A generic QA Project
Plan shall be reviewed periodically to ensure that its content continues to be valid and applicable
to the program over time.
2.4.2 Level of Detail
The level of detail of the QA Project Plan should be based on a graded approach so that
the level of detail in each QA Project Plan will vary according to the nature of the work being
performed and the intended use of the data. As a result, an acceptable QA Project Plan for some
environmental data operations may require a qualitative discussion of the experimental process
and its objectives while others may require extensive documentation to adequately describe a
complex environmental program.
2.5 QA PROJECT PLAN PREPARATION AND APPROVAL
The QA Project Plan may be prepared by an EPA organization, a contractor, an assistance
agreement holder, or another Federal agency under an interagency agreement. Except where
specifically delegated in the Quality Management Plan of the EPA organization sponsoring the
work, all QA Project Plans prepared by non-EPA organizations must be approved by EPA before
implementation.
The QA Project Plan shall be reviewed and approved by an authorized EPA reviewer to
ensure that the QA Project Plan contains the appropriate content and level of detail. The
authorized reviewer, for example the EPA project manager1 with the assistance and approval of
the EPA QA Manager or by the EPA QA Manager alone, are defined by the EPA organization's
Quality Management Plan. In some cases, the authority to review and approve QA Project Plans
is delegated to another part of the EPA organization covered by the same Quality Management
1 This term refers to the EPA official responsible for the project. This individual may also be called Project Officer,
Delivery Order Project Officer, Work Assignment Manager, or Principal Investigator.
Final
EPAQA/R-5 8 March 2001
-------
Plan. In cases where the authority to review and approve QA Project Plans is delegated in writing
by EPA to another organization (i.e., a Federal agency or a State under an EPA-approved Quality
Management Plan when the environmental data operation itself has been delegated to that
organization for implementation), it is possible that the EPA project manager and EPA QA
Manager may not be involved in the review and approval steps.
2.6 QA PROJECT PLAN IMPLEMENTATION
None of the environmental work addressed by the QA Project Plan shall be started until
the QA Project Plan has been approved and distributed to project personnel except in situations
requiring immediate action to protect human health and the environment or operations conducted
under police powers. Subject to these exceptions, it is the responsibility of the organization
performing the work to assure that no environmental data are generated or acquired before the
QA Project Plan is approved and received by the appropriate project personnel. However, EPA
may grant conditional approval to a QA Project Plan to permit some work to begin while non-
critical deficiencies in the QA Project Plan are being resolved.
The organization performing the work shall ensure that the QA Project Plan is
implemented as approved and that all personnel involved in the work have direct access to a
current version of the QA Project Plan and all other necessary planning, implementation, and
assessment documents. These personnel should understand the requirements prior to the start of
data generation activities.
2.7 QA PROJECT PLAN REVISION
Although the approved QA Project Plan must be implemented as prescribed; it is not
inflexible. 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 shall
determine if the change significantly impacts the technical and quality objectives of the project.
When a substantive change is warranted, the originator of the QA Project Plan shall modify the
QA Project Plan 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 received and
approved (at least verbally with written follow-up) by project personnel, shall the change be
implemented.
For programs or projects of long duration, such as multi-year monitoring programs or
projects using a generic QA Project Plan, the QA Project Plans shall be reviewed at least annually
by the EPA Project Manager (or authorized representative). When revisions are necessary, the
QA Project Plan must be revised and resubmitted for review and approval.
Final
EPAQA/R-5 9 March 2001
-------
(This page is intentionally blank.)
Final
EPAQA/R-5 10 March 2001
-------
CHAPTER 3
QA PROJECT PLAN ELEMENTS
3.1 CONTENT REQUIREMENTS
The QA Project Plan 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 QA Project Plan
must provide sufficient detail to demonstrate that:
the project technical and quality objectives are identified and agreed upon;
the intended measurements, data generation, 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, including
managers, engineers, scientists, statisticians, and others. The QA Project Plan 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 QA Project Plan, such as the field sampling team, the analytical
laboratory, modelers, and the data reviewers. In all aspects of the QA Project Plan, the use of
national consensus standards and practices are encouraged.
In order to be effective, the QA Project Plan must specify the level or degree of QA and
QC activities 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 activities applied to a
project will be commensurate with:
the purpose of the environmental data operation (e.g., enforcement, research and
development, rulemaking),
• the type of work to be done (e.g., pollutant monitoring, site characterization, risk
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).
Final
EPAQA/R-5 11 March 2001
-------
The QA Project Plan shall be composed of standardized, recognizable elements covering
the entire project from planning, through implementation, to assessment. These elements 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 - The elements in this group address 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 Data Generation and Acquisition - The elements in this group address all aspects
of project design and implementation. Implementation of these elements ensure
that appropriate methods for sampling, measurement and analysis, data collection
or generation, data handling, and QC activities are employed and are properly
documented.
C Assessment and Oversight - The elements in this group address the activities for
assessing the effectiveness of the implementation of the project and associated QA
and QC activities. The purpose of assessment is to ensure that the QA Project
Plan is implemented as prescribed.
D Data Validation and Usability - The elements in this group address the QA
activities that occur after the data collection or generation 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, including the content and level of detail under each element,
defined by the EPA organization sponsoring the work must be addressed in the QA Project Plan.
If an element is not applicable, state this in the QA Project Plan. Documentation, such as an
approved Work Plan, Standard Operating Procedures, etc., may be referenced in response to a
particular required QA Project Plan element to reduce the size of the QA Project Plan. Current
versions of all referenced documents must be attached to the QA Project Plan itself or be placed
on file with the appropriate EPA office and available for routine referencing when needed. The
QA Project Plan shall also address related QA planning documentation (e.g., Quality Management
Plans) from suppliers of services critical to the technical and quality objectives of the project or
task.
3.2 GROUP A: PROJECT MANAGEMENT
The elements in this group (Table 1) address project management, including project
history and objectives, roles and responsibilities of the participants, etc. These elements document
Final
EPAQA/R-5 12 March 2001
-------
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
Special Training/Certification
Documents and Records
3.2.1 Al - Title and Approval Sheet
On the Title and Approval Sheet, include the title of the plan, the name of the
organization(s) implementing the project, the effective date of the plan, and the names, titles,
signatures, and approval dates of appropriate approving officials. Approving officials may
include:
Organization's Project Manager
Organization's QA Manager
EPA Project Manager
EPA QA Manager
Others, as needed (e.g., field operations manager, laboratory managers,
State and other Federal agency officials)
3.2.2 A2 - Table of Contents
Provide a table of contents for the document, including sections, figures, tables,
references, and appendices. Apply a document control format (Figure 2) on each page following
the Title and Approval Sheet when required by the EPA Project Manager and QA Manager.
EPA QA/R-5
13
Final
March 2001
-------
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 need copies of the approved QA Project
Plan and any subsequent revisions, including all persons responsible for implementation (e.g.,
project managers), the QA managers, and representatives of all groups involved. Paper copies
need not be provided to individuals if equivalent electronic information systems can be used.
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.)
Identify the individual responsible for maintaining the official, approved QA Project Plan.
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, including laboratories providing analytical services.
3.2.5 A5 - Problem Definition/Background
State the specific problem to be solved, decision to be made, or outcome to be achieved.
Include sufficient background information to provide a historical, scientific, and regulatory
perspective for this particular project.
3.2.6 A6 - Project/Task Description
Provide a summary of all work to be performed, products to be produced, and the
schedule for implementation. Provide maps or tables that show or state the geographic locations
of field tasks. This discussion need not be lengthy or overly detailed, but should give an overall
picture of how the project will resolve the problem or question described in A5.
Final
EPAQA/R-5 14 March 2001
-------
3.2.7 A7 - Quality Objectives and Criteria
Discuss the quality objectives for the project and the performance criteria to achieve those
objectives. EPA requires the use of a systematic planning process to define these quality
objectives and performance criteria.
3.2.8 A8 - Special Training/Certification
Identify and describe any specialized training or certifications 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 - Documents and Records
Describe the process and responsibilities for ensuring the appropriate project personnel
have the most current approved version of the QA Project Plan, including version control,
updates, distribution, and disposition.
Itemize the information and records which must be included in the data report package
and specify the reporting format for hard copy and any electronic forms. Records can include raw
data, data from other sources such as data bases or literature, field logs, sample preparation and
analysis logs, instrument printouts, model input and output files, and results of calibration and QC
checks.
Identify any other records and documents applicable to the project that will be produced,
such as audit reports, interim progress reports, and final reports. Specify the level of detail of the
field sampling, laboratory analysis, literature or data base data collection, or modeling documents
or records needed to provide a complete description of any difficulties encountered.
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: DATA GENERATION AND ACQUISITION
The elements in this group (Table 2) address all aspects of data generation and acquisition
to ensure that appropriate methods for sampling, measurement and analysis, data collection or
generation, data handling, and QC activities are employed and documented. The following QA
Project Plan elements describe the requirements related to the actual methods or methodology to
be used for the:
• collection, handling, and analysis of samples;
Final
EPA QA/R-5 15 March 2001
-------
• data obtained from other sources (e.g., contained in a computer data base from
previous sampling activities, compiled from surveys, 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;
otherwise, detailed copies of the methods and/or SOPs must accompany the QA Project Plan
either in the text or as attachments.
Table 2. Group B: Data Generation and
Acquisition Elements
Bl
B2
B3
B4
B5
B6
B7
B8
B9
BIO
Sampling Process Design (Experimental Design)
Sampling Methods
Sample Handling and Custody
Analytical Methods
Quality Control
Instrument/Equipment Testing, Inspection, and Maintenance
Instrument/Equipment Calibration and Frequency
Inspection/ Acceptance of Supplies and Consumables
Non-direct Measurements
Data Management
3.3.1 Bl- Sampling Process Design (Experimental Design)
Describe the experimental data generation 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
• the rationale for the design.
EPA QA/R-5
16
Final
March 2001
-------
3.3.2 B2 - Sampling Methods
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 for projects involving physical sampling.
Where appropriate, identify sampling methods by number, date, and regulatory citation. 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.
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, and preservation methods; and maximum holding times to sample
extraction and/or analysis.
3.3.3 B3 - Sample Handling and Custody
Describe the requirements 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 for projects
involving physical sampling. Sample handling includes 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
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. Where appropriate, analytical methods may be
identified by number, date, and regulatory citation. Address what to do when a failure in the
analytical system occurs, 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.
List any method performance standards. 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 method applications, such as for unusual sample matrices and situations,
appropriate method performance study information is needed to confirm the performance of the
Final
EPAQA/R-5 17 March 2001
-------
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
Identify QC activities needed for each sampling, analysis, or measurement technique. For
each required QC activity, list the associated method or procedure, 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.
QC activities for the field and the laboratory include, but are not limited to, the use of blanks,
duplicates, matrix spikes, laboratory control samples, surrogates, or second column confirmation.
State the frequency of analysis for each type of QC activity, and the spike compounds sources and
levels. State or reference the required control limits for each QC activity 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 applicable statistics (e.g.,
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
Describe how inspections and acceptance testing of instruments, equipment, and their
components affecting quality will be performed and documented to assure their intended use as
specified. 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 or other systems and their components affecting quality 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/Equipment Calibration and Frequency
Identify all tools, gauges, instruments, and other sampling, measuring, and test equipment
used for data generation or collection activities affecting quality that must be controlled and, at
Final
EPA QA/R-5 18 March 2001
-------
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.
3.3.8 B8 - Inspection/Acceptance of Supplies and Consumables
Describe how and by whom supplies and consumables (e.g., standard materials and
solutions, sample bottles, calibration gases, reagents, hoses, deionized water, potable water,
electronic data storage media) shall be inspected and accepted for use in the project. State
acceptance criteria for such supplies and consumables.
3.3.9 B9 - 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. Describe the intended use of the data. Define the acceptance criteria
for the use of such data in the project and specify any limitations on the use of the data.
3.3.10 BIO - Data Management
Describe the project data management process, tracing the path of the data from their
generation to their final use or storage (e.g., the field, the office, the laboratory). 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
information resource management requirements are satisfied.
Describe the process for assuring that applicable Agency information resource
management requirements (EPA Directive 2100) are satisfied (EPA QA Project Plans only). If
other Agency data management requirements are applicable, such as the Chemical Abstract
Service Registry Number Data Standard (EPA Order 2180.1), Data Standards for the Electronic
Final
EPAQA/R-5 19 March 2001
-------
Transmission of Laboratory Measurement Results (EPA Order 2180.2), the Minimum Set of Data
Elements for Ground-Water Quality (EPA Order 7500.1 A), or new data standards as they are
issued by EPA, discuss how these requirements are addressed.
3.4 GROUP C: ASSESSMENT AND OVERSIGHT
The elements in this group (Table 3) address the activities for assessing the effectiveness
of project implementation and associated QA and QC activities. The purpose of assessment is to
ensure that the QA Project Plan is implemented as prescribed.
Table 3. Group C: Assessment and
Oversight Elements
Cl
C2
Assessments and Response
Actions
Reports to Management
3.4.1 Cl - Assessments and Response Actions
Describe each assessment to be used in the project including the frequency and type.
Assessments include, but are not limited to, surveillance, management systems reviews, readiness
reviews, technical systems audits, performance evaluations, audits of data quality, 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 assessment 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 each assessment shall be reported.
Define the scope of authority of the assessors, including stop work orders, and when
assessors are authorized to act.
Discuss how response actions to assessment findings, including corrective actions for
deficiencies and other non-conforming conditions, are to be addressed and by whom. Include
details on how the corrective actions will be verified and documented.
3.4.2 C2 - Reports to Management
Identify the frequency and distribution of reports issued to inform management (EPA or
otherwise) of the project status; for examples, reports on the results of performance evaluations
and system audits; results of periodic data quality assessments; and significant quality assurance
EPA QA/R-5
20
Final
March 2001
-------
problems and recommended solutions. Identify the preparer and the recipients of the reports, and
any specific actions recipients are expected to take as a result of the reports.
3.5 GROUP D: DATA VALIDATION AND USABILITY
The elements in this group (Table 4) address 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 Elements
Dl
D2
D3
Data Review, Verification,
Verification and Validation
and Validation
Methods
Reconciliation with User Requirements
3.5.1 Dl - Data Review, Verification, and Validation
State the criteria used to review and validate — that is, accept, reject, or qualify - data, in
an objective and consistent manner.
3.5.2 D2 - Verification and Validation Methods
Describe the process to be used for verifying and validating data, including the chain-of-
custody for data throughout the life 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.
Provide examples of any forms or checklists to be used. Identify any project-specific calculations
required.
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 reconciliation with user requirements will be
documented, issues will be resolved, and how limitations on the use of the data will be reported to
decision makers.
EPA QA/R-5
21
Final
March 2001
-------
(This page is intentionally blank.)
Final
EPAQA/R-5 22 March 2001
-------
REFERENCES
40 CFR 30, Code of Federal Regulations, "Grants and Agreements With Institutions of Higher
Education, Hospitals, and Other Non-Profit Organizations."
40 CFR 31, Code of Federal Regulations, "Uniform Administrative Requirements for Grants and
Cooperative Agreement to State and Local Governments."
40 CFR 35, Code of Federal Regulations, "State and Local Assistance."
48 CFR 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 Order 2180.1 (June 1987), Chemical Abstract Service Registry Number Data Standard,
U.S. Environmental Protection Agency, Washington, DC.
EPA Order 2180.2 (December 1988), Data Standards for the Electronic Transmission of
Laboratory Measurement Results, U.S. Environmental Protection Agency, Washington,
DC.
EPA Order 5360 A1 (May 2000). EPA Quality Manual for Environmental Programs, U.S.
Environmental Protection Agency, Washington, DC.
EPA Order 5360.1 A2 (May 2000), Policy and Program Requirements for the Mandatory
Agency-wide Quality System, 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.
U.S. Environmental Protection Agency, 2001. EPA Requirements for Quality Management
Plans (QA/R-2), EPA/240/B-01/002, Office of Environmental Information.
U.S. Environmental Protection Agency, 2000a. Guidance for Data Quality Assessment:
Practical Methods for Data Analysis (QA/G-9), EPA/600/R-96/084, Office of
Environmental Information.
Final
EPAQA/R-5 23 March 2001
-------
U.S. Environmental Protection Agency, 2000b. Guidance for the Data Quality Objectives
Process (QA/G-4), EPA/600/R-96/055, Office of Environmental Information.
U.S. Environmental Protection Agency, 1998. Guidance for Quality Assurance Project Plans
(QA/G-5), EPA/600/R-98/018, Office of Research and Development.
U.S. Environmental Protection Agency, 1995. 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, 1980. Interim Guidelines and Specifications for
Preparing Quality Assurance Project Plans, QAMS-005/80, Office of Research and
Development.
Final
EPAQA/R-5 24 March 2001
-------
APPENDIX A
CROSSWALKS AMONG QUALITY ASSURANCE DOCUMENTS
A.1 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 QA
Project Plan defined in this document with the steps defined in Guidance for the Data Quality
Objectives Process (QA/G-4) (EPA 2000b), 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 QA Project Plan.
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
8.0
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
Calibration Procedures and
Frequency
QA/R-5 ELEMENTS
Al
A2
A5
A6
A3
A4
A8
A9
A7
Bl
B2
B3
B7
Title and Approval Sheet
Table of Contents
Problem Definition/Background
Project/Task Description
Distribution List
Project/Task Organization
Special Training/Certification
Documents and Records
Quality Objectives and Criteria
Sampling Process Design
Sampling Methods
Sample Handling and Custody
Instrument/Equipment Calibration and
Frequency
EPA QA/R-5
A-l
Final
March 2001
-------
QAMS-005/80 ELEMENTS
9.0
10.0
11.0
12.0
13.0
14.0
15.0
16.0
Analytical Procedures
Data Reduction, Validation, and
Reporting
Internal Quality Control Checks
and Frequency
Performance and Systems
Preventive Maintenance
Specific Routine Procedures Mea-
surement Parameters Involved
Corrective Action
QA Reports to Management
QA/R-5 ELEMENTS
B4
Dl
D2
B9
BIO
B5
Cl
B6
D3
Cl
C2
Analytical Methods
Data Review, Verification, and
Validation
Verification and Validation Methods
Non-direct Measurements
Data Management
Quality Control
Assessments and Response Actions
Instrument/Equipment Testing,
Inspection, and Maintenance
Reconciliation with User Requirements
Assessments and Response Actions
Reports to Management
EPA QA/R-5
A-2
Final
March 2001
-------
A.3 CROSSWALK BETWEEN THE DQO PROCESS AND THE QA PROJECT PLAN
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
A8 Special Training/
Certification
A9 Documents and Records
Title and approval sheet.
Document control format.
Distribution list for the QA Project Plan
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 to the Decision
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
N/A
Step 3 : Identify the Inputs to the Decision
Step 7: Optimize the Design for Obtaining Data
EPA QA/R-5
A-3
Final
March 2001
-------
Elements
Requirements
DQO Overlap
DATA GENERATION AND ACQUISITION
B 1 Sampling Process Design
(Experimental Design)
B2 Sampling Methods
B3 Sample Handling and
Custody
B4 Analytical Methods
B5 Quality Control
B6 Instrument/Equipment
Testing, Inspection, and
Maintenance
B7 Instrument/Equipment
Calibration and
Frequency
B8 Inspection/ Acceptance of
Supplies and
Consumables
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.
Describe quality control procedures that
should be associated with each sampling and
measurement technique. List required 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.
Step 5: Develop a Decision Rule
Step 7: Optimize the Design for Obtaining Data
Step 7: Optimize the Design for Obtaining Data
N/A
Step 3 : Identify the Inputs to the Decision
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 3 : Identify the Inputs to the Decision
N/A
EPA QA/R-5
A-4
Final
March 2001
-------
Elements
B9 Non-direct
Measurements
BIO Data Management
Requirements
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 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 AND OVERSIGHT
Cl Assessments and
Response Actions
C2 Reports to Management
Describe the assessment activities needed for
this project.
Identify the frequency, content, and
distribution of reports issued to keep
management informed.
Step 7: Optimize the Design for Obtaining Data
N/A
DATA VALIDATION AND USABILITY
Dl Data Review,
Verification, and
Validation
D2 Verification and
Validation Methods
D3 Reconciliation With User
Requirements
State the criteria used to accept or reject the
data based on quality.
Describe the process to be used for verifying
and validating 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-5
Final
March 2001
-------
(This page is intentionally blank.)
Final
EPAQA/R-5 A-6 March 2001
-------
APPENDIX B
TERMS AND DEFINITIONS
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.
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.
contractor - any organization or individual that contracts to furnish services or items or perform
work; a supplier in a contractual situation.
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.
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.
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.
Final
EPAQA/R-5 B-l March 2001
-------
environmental data operations - work performed to obtain, use, or report information
pertaining to environmental processes and conditions.
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
movement of the contaminants, such as capping, solidification or vitrification, and biological
treatment.
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, performance
partnership 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.
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.
information resources management - the planning, budgeting, organizing, directing, training
and controls associated with information. The term encompasses both information itself and
related resources such as personnel, equipment, funds and technology.
inspection - an activity such as measuring, examining, testing, or gauging one or more
characteristics of an entity and comparing the results with specified requirements in order to
establish whether conformance is achieved for each characteristic.
Final
EPAQA/R-5 B-2 March 2001
-------
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.
method - a body of procedures and techniques for performing an activity (e.g., sampling,
modeling, chemical analysis, quantification) systematically presented in the order in which they are
to be executed.
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.
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.
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 - 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 - 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 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 - a document that describes a quality system in terms of the
organizational structure, policy and procedures, functional responsibilities of management and
Final
EPAQA/R-5 B-3 March 2001
-------
staff, lines of authority, and required interfaces for those planning, implementing, documenting,
and assessing all activities conducted.
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 activities.
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.
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.
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
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 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.
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, verification concerns the process of
examining a result of a given activity to determine conformance to the stated requirements for that
activity.
Final
EPAQA/R-5 B-4 March 2001
------- |