United States
Environmental Protection
Agency
Office of Environmental
Information
Washington, DC 20460
EPA/240/R-02/003
November 2002
<&EPA Overview of the EPA Quality
System for Environmental
Data and Technology
-------
FOREWORD
This document provides a brief summary of EPA's Quality System for environmental data
and technology for EPA and non-EPA organizations who are not familiar with the system but are
subject to its requirements. It shows where to find detailed information on the requirements and
structure, but does not contain in-depth discussions. For example, this document will help an
individual identify whether their organization needs a Quality Management Plan, and if so, where
to find detailed procedures, specifications, and other information.
EPA's Quality System is a key component in implementing EPA's Information Quality
Guidelines released October 2, 2002 (see www.epa.gov/oei/quality/guidelines/index.html). This
document provides information on the policies and responsibilities defined in EPA Order 5360.1
A2 (May 2000), Policy and Program Requirements for the Mandatory Agency-wide Quality
System. This document does not change any existing EPA policies or create any new
requirements.
EPA works every day to produce quality information products. The information used in
these products are based on Agency processes to produce quality data, such as the quality system
described in this document. Therefore, implementation of the activities described in this document
is consistent with EPA's Information Quality Guidelines and promotes the dissemination of quality
technical, scientific, and policy information and decisions.
This is one of the EPA Quality System Series documents that describe EPA policies and
procedures for planning, implementing, documenting, and assessing the effectiveness of a quality
system. Questions regarding any EPA Quality System Series documents should be directed to:
U.S. EPA
Quality Staff (2811R)
1200 Pennsylvania Avenue, NW
Washington, DC 20460
Phone: (202)564-6830
Fax: (202)565-2441
e-mail: quality@epa.gov
Copies of EPA Quality System Series documents may be obtained from the Quality Staffer by
downloading them from the Quality Staff Home Page:
www.epa.gov/quality
This document is valid for a period of up to five years from the official date of publication.
After five years, this document shall either be reissued without change, revised, or withdrawn
from the Quality System Series documentation.
EPA Quality System _ Final
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EPA Quality System _ _ Final
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TABLE OF CONTENTS
Page
1. BACKGROUND 1
2. GOALS AND BENEFITS OF THE EPA QUALITY SYSTEM 2
3. EPA QUALITY SYSTEM BASICS AND STRUCTURE 3
3.1 Scope 3
3.2 Basis 3
3.3 Organizational Structure of the EPA Quality System 6
3.3.1 EPA Organizations 6
3.3.2 Non-EPA Organizations 7
3.4 Structural Components of the EPA Quality System 7
3.4.1 Graded Approach 9
3.4.2 Policy Components 9
3.4.3 Organization/Program Components 12
3.4.4 Project Components 13
4. REQUIREMENTS 14
4.1 Requirements for EPA Organizations 14
4.2 Requirements for Non-EPA Organizations 15
5. RESPONSIBILITIES 16
5.1 Agency Senior Management Official for Quality 16
5.2 Quality and Information Council/Quality Subcommittee 16
5.3 Office of Environmental Information's Quality Staff 20
5.4 National Program Offices 20
5.5 Regional Offices 20
5.6 Individual Responsibilities 20
5.6.1 EPA Quality Personnel Responsibilities 20
5.6.2 EPA Managers and Staff 21
5.6.3 EPA Extramural Personnel 21
5.7 Non-EPA Organizations 22
6. OTHER SOURCES OF INFORMATION 22
7. REFERENCES 23
APPENDIX A. QUALITY SYSTEM TOOLS 25
A. 1 Program/Organizational Tools 25
A. 1.1 Quality Management Plan 25
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Page
A. 1.2 Quality System Audit 26
A.I.3 QA Annual Report and Work Plans 26
A. 1.4 Training Program 26
A.2 Project Tools 27
A.2.1 Systematic Planning and the Data Quality Objectives Process 27
A.2.2 Quality Assurance Project Plans 27
A.2.3 Standard Operating Procedures 28
A.2.4 Technical Assessments 28
A.2.5 Data Verification and Validation 28
A.2.6 Data Quality Assessment 29
LIST OF FIGURES
Page
1. Example EPA Organizations within the EPA Quality System 6
2. EPA Quality System Components and Tools 8
3. The Project Life Cycle 13
4. Quality Management Responsibilities by Individual 19
LIST OF BOXES
Page
1. How to Use this Document 1
2. Important Definitions 4
3. Examples of Environmental Programs 5
4. Regulations Containing Quality-Related Requirements for non-EPA Organizations ... 11
5. Quality Management Responsibilities for EPA Organizations 17
A-l. Quality Management Tools 25
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OVERVIEW OF THE EPA QUALITY SYSTEM
FOR ENVIRONMENTAL DATA AND TECHNOLOGY
1. BACKGROUND
In order to provide quality products and services, an organization must control its
technical, administrative, and human factors that affect quality. A quality system is the means by
which an organization ensures the quality of the products or services it provides and includes a
variety of management, technical, and administrative elements such as:
• policies and objectives,
• procedures and practices,
• organizational authority,
• responsibilities, and
• accountability.
It provides the framework for planning, implementing, assessing, and improving work performed
by an organization and for performing quality assurance (QA) and quality control (QC) activities.
This document summarizes the EPA's Quality System for environmental data and
technology for those who are not familiar with the system but are subject to its requirements. It
is intended to be a reference guide for EPA managers and staff who implement the EPA Quality
System by summarizing the structure (Sections 3.3 and 3.4), requirements (Section 4),
responsibilities (Section 5), and tools (Appendix A). This document does not provide detailed
information on each subject, instead it shows where to find such information. For example, this
document will help an individual identify whether their organization needs a Quality
Management Plan, and if so, where to find detailed procedures, examples, and other information.
For a description of the topics covered in this document, see Box 1.
Box 1. How to Use this Document
If you are interested in: see Section(s)
A general overview of the EPA Quality System 2 and 3
Organizational structure 3.3 and 5
Components and tools for implementing the EPA Quality System 3.4 and Appendix A
Basic requirements for EPA organizations 4.1
Roles and responsibilities 5
Information for non-EPA organizations 3.4.2.2, 4.2, and 5.7
EPA Quality System Final
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This document can also be used by non-EPA organizations (e.g., State, local, and Tribal
governments; contractors; etc.) to identify the general requirements for their organization
(Sections 3.4.2.2, 4.2, and 5.7) as well as components and tools (Appendix A) that can be used to
satisfy these requirements. However, detailed specifications for non-EPA organizations are not
described because these specifications can not extend beyond what is contained in the Code of
Federal Regulations or in an individual agreement.
2. GOALS AND BENEFITS OF THE EPA QUALITY SYSTEM
The goal of the Agency-wide Quality System is to ensure that environmental programs
and decisions are supported by data of the type and quality needed and expected for their
intended use, and that decisions and applications involving environmental technology are
supported by appropriate quality-assured engineering standards and practices. Effective
implementation of the EPA Quality System leads to several benefits including:
• Scientific Data Integrity - EPA will produce data of known and documented
quality and non-EPA organizations will submit data of known and documented
quality to EPA.
• Reduced or Justifiable Resource Expenditures - Resource expenditures can be
reduced as planned information collection activities are more closely matched to
the information needs. For example, through systematic planning, only the
appropriate type, amount, and quality of data will be collected by EPA, and those
collecting data on behalf of EPA or to satisfy EPA requirements.
• Effective Management of Internal and External Activities - The quality system
requires documentation of activities and oversight for evaluation purposes. This
reduces the potential for waste and abuse.
• Reliable and Defensible Decisions - When the quality of data is known, it is
possible to determine if the data can be used for a specific decision. This reduces
the likelihood of losing challenges to regulations, enforcement actions, permit
appeals, etc., resulting from the use of data of uncertain quality.
• Burden Reduction - As EPA better defines the data needed for a specific
application, the burden on other organizations who are required to collect and/or
report these data may be reduced. Our own internal burden may also be reduced
as we become more efficient.
• Continual Improvement - The continual improvement component of the EPA
Quality System leads to the development of a better and more responsive Quality
System and technical system which should result in better products and services.
EPA Quality System Final
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Overall, successful implementation of the EPA Quality System will reduce the Agency's
vulnerabilities in decision making and increase EPA's credibility by providing the ability to make
reliable, timely, cost-effective, and defensible decisions. The consequences of not having a
successfully implemented quality system include the potential to waste time, money, and other
resources and increase the uncertainty in EPA's decisions.
3. EPA QUALITY SYSTEM BASICS AND STRUCTURE
3.1 Scope
The EPA Quality System encompasses management and technical activities pertaining to
the planning, implementation, assessment, and improvement of environmental programs within
the Agency's scope that involve:
• the collection, evaluation, and use of environmental data, and
• the design, construction, and operation of environmental technology.
Box 2 contains definitions that are useful in understanding the scope of this system; Box 3
contains examples of environment programs to which the EPA Quality System applies. The EPA
Quality System applies uniformly to EPA organizations and to non-EPA organizations funded by
EPA. Section 3.3 describes the organizations that are included within the EPA Quality System.
3.2 Basis
The EPA Quality System is based on ANSI/ASQC E4-1994, Specifications and
Guidelines for Quality Systems for Environmental Data Collection and Environmental
Technology Programs. ANSI/ASQC E4 is an American National Standard for quality
management practices for environmental programs involving the collection and evaluation of
environmental data and the design, construction, and operation of environmental technologies.
This standard provides a basis for planning, implementing, documenting, and assessing an
effective quality system. EPA requires conformance to this standard through internal Orders and
the Code of Federal Regulations (see Section 3.4.2). Copies of the ANSI/ASQC E4 may be
purchased from:
ASQ Quality Press
P.O. Box 3005
Milwaukee, WI 53201-3005
Phone:(800)248-1946
www.asq.org
EPA Quality System Final
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Box 2. Important Definitions3
Environmental Programs - activities involving the environment, including but not
limited to: characterization of environmental processes and conditions;
environmental monitoring; environmental research and development; laboratory
operations on environmental samples; and the design, construction, and operation
of environmental technologies.
Environmental Data - any measurements or information that describe
environmental processes, locations, or conditions; ecological or health effects and
consequences; or the performance of environmental technology. For EPA,
environmental data include both primary data (i.e., information collected directly
from measurements) and secondary/existing data (i.e., data that were collected for
other purposes or obtained from other sources, including literature, industry
surveys, models, data bases, and information systems).
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.
Quality Assurance (QA) - an integrated system of management activities involving
planning, implementation, assessment, reporting, and improvement to ensure that a
process, item, or service is of the type and quality needed. QA is typically applied
by managers or technical personnel assigned to a specific oversight role. Example
QA activities include technical and management assessments of field and analytical
operations.
Quality Control (QC) - an overall system of technical activities that measures the
performance of a process, item, or service against defined standards to verify that
the performance meets the stated requirements. QC is typically applied by
technical personnel. Example QC activities include the use of control samples
during sample collection, handling, and analysis, and activities such as data review.
Trom ANSI/ASQC E4-1994
EPA Quality System Final
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Box 3: Examples of Environmental Programs
Example environmental programs include but are not limited to:
Characterize and/or evaluate the states and/or conditions of environmental or
ecological systems and the health of human populations;
Characterize and/or evaluate chemical, biological, physical, or radioactive
constituents in environmental and ecological systems, and their behavior and
associated interfaces in those systems;
Establish the ambient conditions in air, water, sediments, and soil in terms of
physical, chemical, radiological, or biological characteristics;
Determine and/or categorize radioactive, hazardous, toxic, and mixed wastes in the
environment and to establish their relationships with and/or impact on human health
and ecological systems;
Quantify and/or monitor the waste and effluent discharges to the environment from
processes and operations (e.g., energy generation, metallurgical processes,
chemicals production), during either normal or upset conditions (i.e., operating
conditions that cause pollutant or contaminant discharges);
Develop and/or evaluate environmental technology for waste treatment, storage,
remediation, and disposal; pollution prevention; and pollution control and the use of
the technology to generate and/or collect data (e.g., treatability and pilot studies);
Map environmental processes and conditions, and/or human health risk data, etc.
(e.g., geographical information system);
Support enforcement and/or compliance monitoring efforts;
Develop or evaluate methods for use in the collection, analysis, and use of
environmental data;
Develop and/or evaluate models of environmental processes and conditions and
use models to characterize environmental processes or conditions;
Develop, revise, or use of information technology and management system
operations that impact the quality of the results of environmental programs (e.g.,
electronic databases with environmental information including data entry, handling,
transmission and analysis, and laboratory information management systems); and
Monitor or address concerns over the occupational health and safety of personnel in
EPA facilities (e.g., indoor air quality measurements) and in the field (e.g., chemical
dosimetry, radiation dosimetry).
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3.3 Organizational Structure of the EPA Quality System
3.3.1 EPA Organizations
Because of the diversity (and dispersion) of programs within EPA, the Agency-wide
Quality System is decentralized so organizations have individual quality systems that specifically
address their needs. As a result, the EPA Quality System is composed of individual quality
systems developed and implemented by the various EPA Regions, National Program Offices, and
the National Centers and Laboratories in the Office of Research and Development. These
individual quality systems are supported by the quality systems of non-EPA organizations who
receive funding from, and provide data and information to, EPA.
Figure I1 shows the organizational structure for quality management in EPA. Overall,
there are more than 40 EPA organizations that maintain quality systems. These organizations are
usually at the Regional Office level, at the level immediately below each National Program
Quality and Information
Council and
Quality Subcommittee
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Figure 1. Example EPA Organizations within the EPA Quality System
^ote, not all EPA Offices are shown on Figure 1. See www.epa.gov/epahome/organization.htm for a
current list of EPA Offices.
EPA Quality System
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Office, and at the National Center and Laboratory level. Specialized, complex, large, or highly-
visible programs (for example, EPA's Great Lakes National Program) also may have their own
quality systems. Typically, such programs cut across organizational lines and have their own
organizational infrastructure. The Assistant Administrator for Environmental Information is
responsible for developing and coordinating the EPA Quality System in addition to directing its
implementation within EPA. This role is performed by the Quality Staff. See Section 5 for a
discussion of the specific responsibilities of each of these organizations.
3.3.2 Non-EPA Organizations
Non-EPA organizations are required to develop and implement quality systems to support
their environmental programs and projects funded or regulated by EPA. This quality system may
be part of an existing system for the organization as long as it addresses all of EPA's
requirements. Organizations that may be affected by the EPA Quality System requirements
include: other Federal departments and agencies; State, local, and Tribal governments; academic
and other non-profit organizations; and commercial business enterprises. Quality management
requirements are either defined through the Federal Regulations that specify, in general, what an
organization must do to comply with EPA policy, or are negotiated into agreements that are not
covered by the Federal Regulations. See Sections 3.4.2.2 and 4.2 for discussions on the specific
regulations and requirements for non-EPA organization.
3.4 Structural Components of the EPA Quality System
Figure 2 illustrates the components to consider when developing an individualized
Quality System. There are 3 types of components in the EPA Quality System:
1. Policy - These components address quality-related policies and regulations that EPA
organizations and non-EPA organizations must address.
2. Organization/Program - These components address the management and
implementation component of the individual Quality System. The components are
applied across an entire organizations (e.g., a Regional Office or a National Research
Laboratory) or to a specialized, complex, large, or highly-visible programs (for example,
EPA's Great Lakes National Program).
3. Project - These components address the project-specific components that are applied
to individual projects (within an organization or program) to ensure that the project
objectives are achieved.
Figure 2 also shows some of the quality management tools EPA has developed to assist in
developing and implementing a quality system. These tools are described in Appendix A.
EPA Quality System Final
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Consensus Standards
ANSI/ASQC E4
ISO 9000 Series
External Policies
Contracts - 48 CFR 46
Assistance Agreements
40 CFR 30, 31, and 35
Internal EPA Policies
EPA Order 5360.1
EPA Manual 5360
EPA Program &
Regional Policy
Quality System
Documentation
(e.g., Quality Management Plan)
Supporting System Elements
(e.g., Procurements,
Computer Hardware/Software)
Training/Communication
(e.g., Training Plan,
Conferences)
I
Annual Review and Planning
(e.g., QA Annual Report
and V\fork Plan)
System Assessment
(e.g., Quality System Audit)
Systematic
Planning
(e.g., DQO Process)
PLANNING
IMPLEMENTATION
ASSESSMENT
........j
Defensible Products and Decisions
Figure 2. EPA Quality System Components and Tools
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3.4.1 Graded Approach
The development and implementation of a quality system should be based on a "graded
approach." This means that the components and tools of a quality system (Figure 2) are applied
according to the scope and nature of an organization, program, or project and the intended use of
its products or services. This approach recognizes that a "one size fits all" approach to quality
management is not appropriate and that the quality system of different organizations and program
should (and will) vary according to the specific needs of the organization. For example, the
quality expectations of a research program are different from that of a regulatory compliance
program because the intended use of the products differs.
3.4.2 Policy Components
The policy components of the EPA Quality System consist of:
/ Agency-wide policies specific to EPA organizations,
/ Agency-wide policies for non-EPA organizations that perform environmental
programs on behalf of EPA, and
/ Organization and program-specific policies for both EPA and non-EPA
organizations. These policies are consistent with one another and are based on the
national consensus standard ANSI/ASQC E4.
3.4.2.1 Agency-wide Internal Policy
Agency-wide policies for EPA organizations are contained in EPA Order 5360.1 A2 and
EPA Manual 5360 Al. Together, these documents define the Agency-wide Quality System.
Copies of these documents are available atwww.epa.gov/quality/tools-pol.html.
EPA Order 5360.1 A2 (May 2000), Policy and Program Requirements for the
Mandatory Agency-wide Quality System - Establishes the minimum requirements for
EPA organizations covered by the mandatory Agency-wide Quality System including
conformance to ANSI/ASQC E4-1994. Contains requirements specific to EPA such as
developing Quality Management Plans, ensuring adequate resources, providing training,
etc. Describes responsibilities for EPA management, staff, and quality management
personnel.
EPA Manual 5360 Al (May 2000), EPA Quality Manual for Environmental Programs
- Known as the Quality Manual. Provides implementation requirements for EPA
organizations covered by the mandatory Quality System defined in EPA Order 5360.1.
Addresses the implementation of quality management activities, including inherently
governmental functions (i.e., the limitations on the use of non-EPA organizations for
EPA Quality System Final
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quality-related activities); reporting requirements; requirements for organizations funded
by EPA; requirements for reporting results from applicable environmental programs;
Quality System requirements and guidance documents; user-specific quality-related
guidance; and dispute resolution. Provides details on documenting compliance with EPA
Order 5360.1.
3.4.2.2 Agency-wide External Policy
Quality System policies and requirements for non-EPA organizations funded by EPA are
contained in the Code of Federal Regulations (CFR). There are four basic regulations that apply
to extramural agreements (i.e., contracts, grants, and cooperative agreements, as well as any work
assignments, delivery orders, or tasks orders that are contained in the above). Box 4 contains
information on which requirement applies to an individual or organization. Each regulation is
described below and the full text is available at www.epa.gov/quality/exmural.html.
48 CFR 46, "Quality Assurance" - Contains requirements for contracts, work
assignments, delivery orders, and task orders. Allows Federal agencies to select a
national consensus standard as a basis for their quality requirements. EPA uses
ANSI/ASQC E4 as its basis and requires that offerers/contractors submit a Quality
Management Plan (or equivalent) and a QA Project Plan (or equivalent) to demonstrate
conformance to the standard.
40 CFR 30, "Grants and Agreements with Institutions of Higher Education, Hospitals
and Other Non-Profit Organizations" - Contains requirements for organizations
identified in title. Requires that grantees comply with ANSI/ASQC E4. EPA requires
that grantees submit a Quality Management Plan (or equivalent) and a QA Project Plan
(or equivalent) to demonstrate conformance.
40 CFR 31, "Uniform Administrative Requirements for Grants and Cooperative
Agreements to State and Local Governments" - Contains requirements for grants and
cooperative agreements to State, local, and Tribal Governments. Requires that grantees
develop and implement quality-related practices to produce data of adequate quality to
meet project objectives. EPA has issued clarifying language to require grantees to
comply with ANSI/ASQC E4-1994 and submit a Quality Management Plan and QA
Project Plans (or equivalents) to demonstrate conformance. This clarifying language is
available at www.epa.gov/ogd/ quality_ assurance_ requirements.htm and is consistent
with 40 CFR 30.
40 CFR 35, "State and Local Assistance" - Contains program-specific requirements for
financial assistance agreements to State, local, and Tribal governments. Requires that
grantees comply with 40 CFR 31.
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Box 4. Regulations containing Quality-Related Requirements
for non-EPA Organizations
Contractor
Consultant
Federal
Agency
Hospital
Institute of Higher
Education
Local Government
Non-profit
Organization
Permittees
Regulated Entity
State Government
Tribal Government
Contract
48CFR46
40 CFR 46
N/A
48 CFR 46
48 CFR 46
48 CFR 46
48 CFR 46
N/A
N/A
48 CFR 46
48 CFR 46
Cooperative
Agreement
N/A
N/A
N/A
40 CFR 30
40 CFR 30
40 CFR 30,
31,35
40 CFR 30
N/A
N/A
40 CFR 30,
31,35
40 CFR 30,
31,35
Grant*
N/A
40 CFR 30
N/A
40 CFR 30
40 CFR 30
40 CFR 30,
31, 35
40 CFR 30
N/A
N/A
40 CFR 30,
31,35
40 CFR 30,
31,35
Inter-Agency
Agreement
N/A
N/A
Negotiated into
each agreement
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Agency Mandates
N/A
N/A
Contained in the individual Federal Regulation
Contained in the individual Federal Regulation
Contained in the individual Federal Regulation
Contained in the individual Federal Regulation
Contained in the individual Federal Regulation
Contained in the Federal Regulation under
which the permit was issued as well as the
specific requirements contained in the permit
Contained in the individual Federal Regulation
Contained in the individual Federal Regulation
Contained in the individual Federal Regulation
*Grants include Performance Partnership Grants and Performance Partnership Agreements.
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Quality requirements are negotiated into interagency agreements and consent agreements,
and may be included in consent orders. This is done on a case-by-case basis by the EPA
organization sponsoring or overseeing the work. Additional quality requirements may be
included in Federal regulations. For example, 40 CFR 160.35, "Federal Insecticide, Fungicide,
Rodenticide Act," contains additional quality management requirements specific to this Act.
3.4.2.3 Organizational-specific or Program-specific Policies for both EPA and non-EPA
Organizations
Each EPA organization or program integrates the Agency-wide quality policies into its
individual quality policies, procedures, and practices. These organizations or programs also:
(1) tailor internal policies in their Quality Management Plan (see Appendix A,
Section A. 1.1) to better meet their organization-specific needs; and
(2) define additional quality-related requirements for non-EPA organizations to
ensure that program-specific goals and objectives are satisfied. These
requirements are written into program-specific Federal Regulations or individual
extramural agreements.
All program or organization-specific policies must be consistent with the Agency-wide policies.
3.4.3 Organization/Program Components
The organization/program components include management policies and processes that
have broad application across an organization or program. There are four key components:
Quality System Documentation; System Assessments; Annual Reviews and Planning; and
Training. Successful implementation of each component is essential to an effective Quality
System. For each of these components, EPA has developed tools to assist in the implementation.
These tools are italicized in the discussion below and described in Section A. 1 of Appendix A.
The use of a component or tool should reflect the needs of the organization relative to its
environmental programs and the organization's policy. The Organization/Program components
should address the policies and responsibilities that apply to activities that are common to all
projects performed by (or for) the organization or program. For example, an organization's
policy requiring QA Project Plans along with the process for reviewing and approving those
plans should be included in the quality system documentation (an Organization/Program
component) since the process would apply to all QA Project Plans. The Organization/Program
components include:
Quality System Documentation - Documentation that describes the authorities, policies,
and procedures specific to an organization. EPA organizations are required to document
their quality system in a Quality Management Plan.
EPA Quality System Final
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System Assessments - Systematic assessments of a program and/or organization's
quality system. EPA uses Quality Systems Audits, Management System Reviews, and
other assessment techniques to evaluate EPA and supporting organizations. EPA
organizations are required to assess their organization at least annually.
Annual Reviews and Planning - A review of the activities within, and changes to, an
organization's quality system; work accomplished; and the planning of future quality-
related activities. Each EPA organization is required to submit a QA Annual Report and
Work Plan to document their review and planning.
Training - Education to ensure that all personnel with responsibility for management,
data collection activities, or the use of environmental technology have the necessary
skills, knowledge, and proficiency in accordance with their organization's quality system.
EPA organizations are required to document their Training Program in their Quality
Management Plan.
3.4.4 Project Components
These components apply to projects within an organization or program that involve
environmental data generation, acquisition, and use. Note that projects are not limited to those
involving the collection of environmental measurements; the project components of the EPA
quality system also apply to projects involving the use of measurements collected for a different
project or purpose, produced from models, and compiled from other sources such as data bases or
the literature.
There are three project components
- planning, implementation, and
assessment - that correspond to the Project
Life Cycle (see Figure 3) and lead to a
specific product or decision. The project
life cycle is iterative in nature; each
component feeds back into the others for
improvements. Use of each component is
critical for ensuring that the quality of
environmental information can be
determined and whether the information
can be used for a specific decision.
Results
inform future
studies
Planning
Planning documents,
\ performance criteria,
\Standard Operating
Procedures
Product
or Decision
_A
Implementation
and Oversight
Statistical \
analysis and
scientific
conclusions
Assessment and
Improvement
/Aquired data w/
/ accompanying
/ quality-related
' information
Figure 3. The Project Life Cycle
For each project component, EPA has developed quality management tools to assist in the
implementation. These tools are italicized in the discussion below and described in Section A.2
of Appendix A. Individuals who typically use these tools are identified in Section 5.
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Planning: Prospective data users use systematic planning., such as the Data Quality
Objectives Process, to develop performance criteria for the data (i.e., the type, quantity,
and quality of data needed for a specific purpose), to develop a sampling plan that
satisfies the criteria, and to determine the level of oversight and quality control activities
needed to ensure the criteria are satisfied. The systematic planning results are
documented in the QA Project Plan or other planning documents.
Implementation and Oversight: Data are acquired according to the approved methods
and procedures documented in the QA Project Plan and Standard Operating Procedures.
Oversight is performed using technical audits and assessments (such as product/service
or process quality audits) to determine if the data are being acquired as required by the
QA Project Plan and other planning documents. Actions are taken to correct problems
identified through the audits or assessments.
Assessment: Project personnel use technical knowledge and statistical methods to
determine whether or not the data meet the user's needs. The data are formally verified
and validated to ensure that the measured values are free of gross errors due to procedural
or technical problems and then are analyzed to determine if they meet the performance
criteria documented in the QA Project Plan (data quality assessment). The results of a
project may also be peer reviewed.
Also, an assessment of the overall project may be performed as part of a system assessment
described in Section 3.4.4 at any time during the project life-cycle,
4. REQUIREMENTS
4.1 Requirements for EPA Organizations
There are 11 basic quality management requirements defined in EPA Order 5360.1 for all
EPA organizations covered by the EPA Quality System. These requirements are to:
/ Conform to the minimum specifications of ANSI/ASQC E4-1994 - see Section
3.2 for information about ANSI/ASQC E4-1994;
/ Identify a QA Manager and ensure that this individual quality function is
independent from environmental data collection and use - see Section 5.6.1 for
responsibilities of a QA Manager;
/ Develop a Quality Management Plan and implement this plan following Agency
approval - see Section A. 1.1 of Appendix A for more information on quality
management plans;
/ Provide sufficient resources to implement the quality system;
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/ Perform an assessment of the effectiveness of the quality system at least annually
and implement corrective actions based on assessment results in a timely manner -
see Section A. 1.2 of Appendix A for more information on assessments of quality
systems;
/ Submit an QA Annual Report and Work Plan that summarizes the previous year's
activities and outlines the work proposed for the current year - see Section A. 1.3
of Appendix A for more information on the QA Annual Report and Work Plan;
/ Implement Agency-wide Quality System requirements in all applicable EPA-
funded extramural agreements - see Section 3.4.2.2 for specific requirements;
/ Provide appropriate training for all levels of management and staff to assure that
quality-related responsibilities and requirements are understood - see Section
A. 1.4 of Appendix A for more information on training;
/ Use a systematic planning approach to develop acceptance or performance criteria
for all work covered by the EPA Quality System - see Section A.2.1 of Appendix
A for more information on systematic planning;
/ Have approved QA Project Plans, or equivalent documents, for all applicable
projects and tasks involving environmental data - see Section A.2.2 of
Appendix A for more information on QA Project Plans; and
/ Assess existing data, when used to support Agency decisions or other secondary
purposes, to verify that they are of sufficient quantity and adequate quality for
their intended use - see Section A.2.3-A.2.5 of Appendix A for more information
on data assessment.
EPA Order 5360.1 also contains program-specific requirements and responsibilities for EPA
managers and staff.
4.2 Requirements for Non-EPA Organizations
In general, EPA requires that recipients of funds for work involving environmental data
collection comply with the American National Standard ANSI/ASQC E4-1994, Specifications
and Guidelines for Quality Systems for Environmental Data Collection and Environmental
Technology Programs. In addition, each EPA organization's Quality Management Plan
describes how the organization will interact with, and any additional requirements for, the
organizations they fund.
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To demonstrate conformance to E4-1994, EPA requires two forms of documentation:
1. Documentation of the organization quality system (usually called a Quality
Management Plan), and
2. Documentation of the application of quality-related activities to an
activity-specific effort (usually called a QA Project Plan)2.
Use of existing quality system documentation, such as that required by the ISO 9000 family of
quality standards, may be an acceptable alternative.
For grants, contracts, and other extramural agreements that consist of a single project or
task, these two documents may be combined into a single document that describes the
organization's quality system and the application of this system to the work performed under the
grant or contract. This can only be done with permission of the EPA QA Manager who will
identify the elements that should be addressed in a combined document.
5. RESPONSIBILITIES
Responsibility for the EPA Quality System is spread across the Agency. Each EPA
organization described below has a specific role and set of responsibilities. These
responsibilities are summarized in Box 5 and the relationship between these organizations and
individuals is shown in Figure 4.
5.1 Agency Senior Management Official for Quality
The Assistant Administrator for Environmental Information is the Agency's Senior
Management Official for Quality and is responsible for developing and coordinating the Agency-
wide Quality System and directing its implementation within EPA. In addition to the Agency-
wide Quality responsibilities, the Assistant Administrator for Environmental Information has
responsibilities specific to this office that are described in Section 5.4.
5.2 Quality and Information Council/Quality Subcommittee
The Quality and Information Council is an advisory group of Agency senior managers
that assists the Assistant Administrator for Environmental Information in the role of Senior
Management Official for Quality. This Council is supported by the Quality Subcommittee which
Note: EPA may provide the QA Project Plan (or equivalent documentation). In this case, the fund
recipient would simply implement the Plan provided and not create a new one.
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Box 5. Quality Management Responsibilities for EPA Organizations1
Asst. Administrator
Env. Information2
Quality Staff
National
Program Offices
Regional Offices
Quality
Management
Policies
Issue policies
recommended by Quality
Staff and/or Quality and
Information Council and
Quality Subcommittee
Develop for Agency-wide
use
Develop for program - may
apply to Regions
Apply Agency-wide policies
Develop for Region, and
State, local, and Tribal
governments
Apply Agency-wide policies
Quality
Management Plan
Approve EPA plans
Review EPA organization's
plans
Recommend approval to
the Sr. Official for Quality
Develop and implement for
each program laboratory and
organization
Review/approve the plans of
non-EPA organizations
funded by EPA
Develop and implement for
Region
Review/approve the plans of
State, local, and Tribal
governments, and non-EPA
organizations funded by EPA
Quality
Management
Procedures and
Guidance
Issue procedures and
guidance developed by
Quality Staff
Develop for EPA, non-EPA
organizations funded by
EPA, and for internal use
Develop for program and
activities delegated to
Regions; coordinate
implementation with Regions
Develop for Regions - may
apply to State, local, and
Tribal governments
Resources for
Quality
Management
Activities
Recommend
improvements and
balance resource
allocation
Monitor resource allocation
across Agency and
highlight differences and
inconsistencies
Provide sufficient resources
to implement organization's
Quality Management Plan for
their Office and related
Regional programs
Provide sufficient resources
to implement the
organization's Quality
Management Plan
System
Assessments and
Evaluation
Mandate Agency-wide
corrective actions
Periodically review each
EPA organization
Identify Agency-wide
problems and corrective
actions
Perform internal
assessments
Assess supporting
organizations (EPA or
otherwise)
Perform internal
assessments
Assess supporting
organizations (EPA or
otherwise), including State
agencies
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Box 5. Quality Management Responsibilities for EPA Organizations1
Asst. Administrator
Env. Information2
Quality Staff
National
Program Offices
Regional Offices
QA Annual Report
and Work Plan
Report to EPA
Administrator
Compile information in
report to AA/OEI and EPA
Administrator
Report yearly
Report yearly
Communication
and Outreach
Represents EPA on
quality practices and
issues.
Perform outreach and
consulting
Host monthly conference
calls, annual National QA
Conference
Liaison with Quality Staff,
EPA QA Managers, and
holders of assistance
agreements
Liaison with Quality Staff,
other EPA QA Managers and
State, local, and Tribal
governments
Training
Issue generic training
materials
Develop generic training
materials
Provide generic training on
limited basis
Develop program-specific
training
Provide training to program
management and staff
Develop Region-specific
training
Provide training to Regional
management and staff
Ensure training is available
for State, local, and Tribal
governments
Employee
Evaluation
(Performance)
Standards
Issue general standards
policy
Develop general standards
policy
Ensure quality-related
activities reflected in
performance standards
Ensure Quality-related
activities reflected in
performance standards
1Non-EPA organizations are responsible for developing an EPA-approved Quality Management Plan. This plan should address the other
elements listed on this table with the exception of performance standards.
2ln conjunction with the Quality and Information Council and Quality Subcommittee.
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EPA Administrator
Responsible for EPA's Quality System
Assistant Administrators
Responsible for Org.'s Quality System.
Issues Org's QMP
QA Representative
Coordinates quality
management for AA
Assistant Administrator
Environmental Information
Sr. Mgt. Official for Quality
Issues Agency policy/procedures
Oversees Agency-wide implementation
Regional Administrators
Responsible for Region's Quality System
Issues Region's QMP
. i .j. i
• Assists AA/OE1 in developing policy |
Quality Staff
Develops Agency policy/procedures.
Performs oversight of implementation
QMPs, QAARWPs, QSAs, Training
Office, Center, Lab Directors
Responsible for Org.'s Quality System.
Issues Org's QMP
QA Manager/Director
Develops Office policy & oversees implementation
QMPs, QAARWPs, QSAs, Training
DQOs, QAPPs, TAs, DQAs
QA Staff
Assists QA Manager
QMPs, QSAs, Training, DQOs, QAPPs,
SOPs, TAs, DQAs
QMP = Quality Managment Plan '
I QAARWP = QA Annual Reports and Work Plans)
. QSAs = Quality SystemAassessments
I DQO = Data Quality Objectives
i QAPP = Qualitiy Assurance Project Plan
SOP = Standard Operating Procedure
| TA = Technical Assessment
Project Personnel
Implements policies and procedures
DQOs, QAPPs, SOPs, TAs, DQA
DQA=Data Quality Assessment/Data Review
State, Local, and Tribal Govts.
Contractors, Cooperators, Grantees,
Persons under Env. Statutes, Stakeholders
Implements policies and procedures
QMPs, DQOs, QAPPs, SOPs, TAs, DQA
Figure 4. Quality Management Responsibilities by Individual
addresses Agency-wide policy issues in the implementation of the quality program. Both groups
function as a forum in which Agency-wide Quality System issues are resolved.
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5.3 Office of Environmental Information's Quality Staff
The Quality Staff of the Office of Environmental Information supports the Assistant
Administrator for Environmental Information in his/her role as Senior Management Official for
Quality. The Staff is the Agency organization assigned the responsibility for developing Agency-
wide policy and procedures, coordinating with EPA's Program Offices, Laboratories, Regional
Offices, and overseeing the implementation of the EPA Quality System. This role includes both
supporting Agency organizations in developing and implementing their individual Quality
Systems and performing assessments on these organizations. Specific responsibilities for the
Quality Staff are described in Box 5.
5.4 National Program Offices
The Assistant or Associate Administrator of each National Program Office (including the
Office of Research and Development) is responsible for its quality system (see Section 3.3 for
example EPA Program Offices). Specific responsibilities of the National Program Offices are
described in Box 5.3 Each National Program Office has a QA Representative that reports to the
Assistant Administrator; advises on quality-related activities; and assists in the planning,
implementation, documentation, and assessment of the organization's quality system. Each line
office within a National Program Office typically has a QA Manager or QA Director, QA
Officers, QA Coordinators, and other QA personnel to provide support to the ongoing operations
of the organization.
5.5 Regional Offices
Each Regional Administrator is responsible for the quality system in the Region. Specific
responsibilities for the EPA Regional Offices are shown in Box 5. Each Regional Office has a
QA Manager, who advises the Region's senior management on quality-related activities, and
assists in the planning, implementation, documentation, and assessment of the Region's quality
system. Each QA Manager is supported by QA personnel that provide support to the ongoing
operations of the organization.
5.6 Individual Responsibilities
5.6.1 EPA Quality Personnel Responsibilities
EPA organizations are required by EPA Order 5360.1 to identify a QA Manager (or QA
Director) who reports on quality issues to the senior management of the organization. This
3 Note, organizations within a National Program Office may have programs that are delegated to the EPA
Regions, States, and Tribal governments, or are supported by Regional, State, or EPA National Research Centers
and Laboratories. In this case, the National Program Office must define the quality management responsibilities for
these programs (in their Quality Management Plan) and ensure these responsibilities are addressed.
EPA Quality System Final
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individual must have sufficient technical and management expertise and authority to conduct
independent oversight of and assure the implementation of the organization's quality system in
the environmental programs of the organization. This individual must function independently of
direct environmental data generation, model development, or technology development. See Gee
(1996) and Pyzdek (1996) for a discussion on roles and activities of a QA Manager for a general
organization. The responsibilities of a QA Manager and other quality management personnel
include:
• facilitating the development and maintaining the organization's Quality
Management Plan;
• representing the organization on matters pertaining to quality management;
providing expert assistance on quality-related issues;
• developing and implementing a QA Training Program;
reviewing and/or approving quality management documentation;
• providing quality management support; and
overseeing and assessing the organization's quality system.
In addition to these general responsibilities, each EPA organization's Quality Management Plan
defines specific responsibilities for its QA Manager and other quality management personnel.
5.6.2 EPA Managers and Staff
Quality-related responsibilities for EPA managers and staff are defined in their
organization's Quality Management Plan. However, EPA managers are also responsible for
ensuring that adequate resources are available for quality management activities and that
environmental programs comply with EPA Order 5360.1. In addition, both EPA managers and
staff are responsible for ensuring their applicable intramural and extramural programs and
activities comply fully with EPA Order 5360.1 and for assuring that the results of environmental
programs are of sufficient quantity and adequate quality for their intended use.
5.6.3 EPA Extramural Personnel
Responsibilities for EPA's Contracting Officers and Contracting Officer's
Representatives are contained in the EPA Manual 1900 (EPA 1998), Contracts Management
Manual (epawww.epa.gov/oamintra/policy/cmm.pdf). Quality-related requirements specific to
the EPA Quality System, such as the use of a QA Review Form and criteria for the Technical
Evaluation Panel, are contained in Chapter 2 of EPA Manual 1900.
EPA's Assistant Agreement Project Officers and other representatives are responsible for
ensuring that all quality-related requirements for both proposals and assistance agreements are
satisfied. More information is available on EPA's Internet (www.epa.gov/ogd) and Intranet
(intranet, epa.gov/oinij hhk/ogd. htm).
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5.7 Non-EPA Organizations
EPA can not define responsibilities for non-EPA organizations beyond what is contained
in the Federal Regulations or in individual agreements (contracts, grants, etc.). General
requirements are for non-EPA organizations are described in Section 3.4.2.2; specific
requirements are contained in each individual agreement with EPA.
6. OTHER SOURCES OF INFORMATION
EPA uses several approaches to disseminate quality-related information to quality
professionals and to collaborate with other organizations on new initiatives to improve quality
management practices and procedures. These approaches include conference calls, guidance,
conferences, Internet sites, and participation in professional societies.
Conference Calls: The EPA QA Managers participate in three monthly conference calls
(one for the Regions, one for the Program Offices, and one for the Office of Research and
Development) to exchange information and to discuss current issues and activities. These
calls are restricted to EPA personnel only and are sponsored by the Quality Staff. EPA
Program Offices may also sponsor conference calls for their quality management
personnel.
Quality System Series Documents: EPA publishes a series of documents that describe the
Agency-wide policies and procedures for planning, implementing, and assessing the
effectiveness of the EPA Quality System and provide criteria and guidance on satisfying
EPA quality requirements. These documents are called the Quality System Series and are
available at www.epa.gov/quality/qa_docs.html.
Annual Quality Management Conference: EPA sponsors an annual conference so that
EPA and other quality professionals can share experiences in managing and
implementing their quality systems and quality-related practices. These conferences may
be general in scope or have a specific focus, depending on the needs expressed by the
quality management community. The conferences include presentations on national
issues and feature presentations by EPA and other organizations on technical issues. The
Quality Staff generally offers training in conjunction with these conferences to provide an
optional opportunity for education and professional development in quality concepts and
practices. Information on past and upcoming conferences is available at
www.epa.gov/quality/meeting.html.
Annual Training Conference: EPA sponsors an annual training conference to equip
quality management professionals with the knowledge and skills they need to promote
effective management and implementation of environmental quality systems. These
conferences offer practical educational opportunities and workshops of varying lengths
that allow conference attendees to participate in Quality-related training events that are
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specific to their organizational needs. The training curriculum includes classes in basic
quality-related concepts and principles as well as specialized and advanced courses.
Information on upcoming training conferences is available at
www. epa. gov/quality/train. html.
Web Sites: The Agency-wide Quality System web site (www.epa.gov/quality) contains
information on the EPA Quality System, quality requirements for organizations funded by
EPA, training, the Annual Conference, the Quality System Series, and contact persons for
each individual EPA organization. Most Regional Offices and a few program offices also
maintain web sites with quality-related information. Link to these sites are maintained on
the EPA Quality System web site.
Professional Societies and Standards Development: EPA participates in the quality
management activities of several professional societies and standards developing
organizations including the American Society for Quality, the American Society for
Testing and Materials, the American National Standards Institute, and the International
Organization for Standardization.
7. 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 Order 1900, Contracts Management Manual, February 1998.
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 Manual 5360 A1 (May 2000). EPA Quality Manual for Environmental Programs, U.S.
Environmental Protection Agency, Washington, DC.
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Gee, G., Richardson, W., and Wortman, B. (1996). CQMPrimer, Quality Council of Indiana,
West Terra Haute, IN.
Pyzdek, T. (1996). The Complete Guide to CQM., Quality Publishing, Tuscon, AZ.
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APPENDIX A
QUALITY SYSTEM TOOLS
For each components used to develop and implement a Quality System (discussed in
Section 3.4), EPA has developed quality management tools to assist in implementation (see Box
A-l for a summary). The sections below describe these tools and provide references to the
Quality System Series documents and other references that discuss the subjects in greater detail.
The most recent copies of the Quality System Series are available at
www.epa.gov/quality/qa_docs.html. In addition, web pages containing these documents, along
with examples, training, and other resources, is identified below for each tool.
Box A-1. Quality Management Tools
Program/Organization Tools Project Tools
Quality Management Plans
Quality System Audits
QA Annual Report and Work Plan
QA Training Program
The Data Quality Objectives Process
QA Project Plans
Standard Operating Procedures
Technical Assessments
Data Validation and Verification
Data Quality Assessment
A.I Program/Organizational Tools
A. 1.1 Quality Management Plan - www.epa.gov/quality/qmps.html
Purpose: To document an organization's quality system for planning, implementing,
and assessing the effectiveness of activities supporting environmental
programs. It also documents how, when, and by whom an organization's
quality system will be implemented and assessed.
Requirement: Both EPA and non-EPA organizations are required to document their
quality systems in a Quality Management Plan (or equivalent).
References: EPA Manual 5360 A1 (May 2000). EPA Quality Manual for
Environmental Programs., U.S. Environmental Protection Agency,
Washington, DC. Chapter 3 (EPA Only)
EPA Requirements for Quality Management Plans (QA/R-2) (2000).
EPA/240/B-01/002, U.S. Environmental Protection Agency, Office of
Environmental Information.
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MacLean, G. E. (1993). Documenting Quality for ISO 9000 and Other
Industry Standards., ASQ Quality Press, Milwaukee, WI.
A.I.2 Quality System Audits - www.epa.gov/quality/qsas.html
Purpose: To verify, by examination and evaluations of objective evidence, that
applicable elements of the quality system are appropriate and have been
developed, documented, and effectively implemented in accordance and in
conjunction with specified requirements (Smith and Russell, 1997).
Requirement: EPA organizations are required to assess their quality systems on at least
an annual basis using quality system audits or other assessment processes.
The Quality Staff also performs periodic audits of EPA organizations to
determine the effectiveness of their quality systems.
References: Guidance on Assessing Quality Systems (G-3) (2002). Peer Review Draft,
U.S. Environmental Protection Agency, Office of Environmental
Information.
Smith, J. L. and Russell, J. P. (1997). The Quality Audit Handbook, ASQ
Quality Press, Milwaukee, WI..
A.I.3 QA Annual Report and Work Plans - www.epa.gov/quality/qaarwps.html
Purpose: To document an EPA organization's previous year's quality-related
activities and those planned for the current year, including current and
planned resources for the management and implementation of quality-
related activities, training, accomplishments, and assessments.
Requirement: EPA organizations are required to submit a QA Annual Report and Work
Plan to the Assistant Administrator of the Office of Environmental
Information every year.
References: EPA Manual 5360 A1 (May 2000). EPA Quality Manual for
Environmental Programs., U.S. Environmental Protection Agency,
Washington, DC. Chapter 4.
A. 1.4 Training Program - www.epa.gov/quality/training.html
Purpose: To assure that all personnel have the necessary skills in order to effectively
accomplish their work and that quality management responsibilities and
requirements are understood at every stage of project implementation
throughout the Agency.
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Requirement: EPA organizations are required to provide training, for all levels of
management and staff, to assure that quality-related responsibilities and
requirements are understood at every stage of project implementation;
References: Guidance for Developing a Training Program for Quality Systems
(QA/G-10) (2000). EPA/600/B-00/004, U.S. Environmental Protection
Agency, Office of Environmental Information.
A.2 Project Components
A. 2.1 Systematic Planning and the Data Quality Objectives Process -
www.epa.gov/quality/dqos.html
Purpose: To identify the expected outcome of the project, the technical goals, the
cost and schedule, and the acceptance criteria for the final result before a
project begins. EPA recommends using the Data Quality Objectives
Process when data are being used to select between two opposing
conditions, such as determining compliance with a standard.
Requirement: EPA organizations must use a systematic planning process to develop
acceptance or performance criteria for the collection, evaluation, or use of
environmental data.
References: Guidance for the Data Quality Objectives Process (QA/G-4) (2000)
EPA/600/R-96/055, U.S. Environmental Protection Agency, Office of
Environmental Information.
The Data Quality Objectives Process for Hazardous Waste Sites
(QA/G-4HW) (2000). EPA/600/R-00/007, U.S. Environmental Protection
Agency, Office of Environmental Information.
A.2.2 Quality Assurance Project Plans - www.epa.gov/quality/qapps.html
Purpose: To document performance criteria and the project-specific plan for
obtaining the type, quality, and quantity of data needed for a specific use.
Requirement: An EPA-approved QA Project Plan (or equivalent) is required for all
projects and tasks involving environmental data.
References: EPA Manual 5360 A1 (May 2000). EPA Quality Manual for
Environmental Programs, U.S. Environmental Protection Agency,
Washington, DC. Chapter 5 (EPA Only)
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EPA Requirements for Quality Assurance Project Plans (QA/R-5) (2001).
EPA/240/B-01/003, U.S. Environmental Protection Agency, Office of
Environmental Information.
Guidance for Quality Assurance Project Plans (QA/G-5) (1998).
EPA/600/R-98/018, U.S. Environmental Protection Agency, Office of
Environmental Information. Office of Research and Development.
A.2.3 Standard Operating Procedures - www.epa.gov/quality/sops.html
Purpose: To document the procedures necessary to carry out routine or repetitive
administrative and technical activities.
Requirement: As Applicable.
References: Guidance for the Preparation of Standard Operating Procedures for
Quality-Related Documents (QA/G-6) (2001). EPA/240/B-01/004, U.S.
Environmental Protection Agency, Office of Environmental Information.
A.2.4 Technical Audits - www.epa.gov/quality/dqa.html
Purpose: To provide a systematic independent technical examination of a project to
determine if a data collection activity is being conducted as planned and
producing data and information of the type and quality specified in the QA
Project Plan. Examples of technical audits include technical system
audits, readiness reviews, surveillance, etc.
Requirement: As Applicable.
References: Guidance on Technical Audits and Related Assessments for Environmental
Data Operations (QA/G-7) (2000). EPA/600/R-99/080, U.S.
Environmental Protection Agency, Office of Environmental Information.
A.2.5 Data Verification and Validation - www.epa.gov/quality/vandv.html
Purpose: To determine if data has been collected in accordance to the QA Project
Plan with respect to compliance, correctness, consistency, and
completeness and to evaluate the technical usability of the data with
respect to the planned objectives or intention of the project.
Requirement: As Applicable.
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References: Guidance on Environmental Data Verification and Validation (G-8)
(2001). Peer Review Draft, U.S. Environmental Protection Agency,
Office of Environmental Information.
Data Validation Functional Guidelines for Evaluating Environmental
Analyses (1996). U.S. Environmental Protection Agency, Region I, EPA-
New England.
A. 2.6 Data Quality Assessment - www. epa. gov/quality/dqa. html
Purpose: To provide a scientific and statistical assessment to determine whether
data are of the right type, quality, and quantity to achieve the objectives of
a project.
Requirement: As Applicable.
References: Guidance for Data Quality Assessment: Practical Methods for Data
Analysis (QA/G-9) (2000). EPA/600/R-96/084, U.S. Environmental
Protection Agency, Office of Environmental Information.
Bibliography of References for Assessing Secondary Data (2000). Draft,
U.S. Environmental Protection Agency.
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