United States
Environmental Protection
Agency
Office of Environmental
Information
Washington, DC 20460
EPA/240/B-01/002
March 2001
irEPA EPA Requirements for
Quality Management Plans
EPA QA/R-2
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FOREWORD
The U.S. Environmental Protection Agency (EPA) has developed the Quality
Management Plan as a means of documenting how an organization will plan, implement, and
assess the effectiveness of its quality assurance and quality control operations applied to
environmental programs. The process of planning, implementing, and assessing these
management systems is called quality management and the product of this process is called the
v Quality System. The Quality Management Plan is part of the mandatory Agency- wide Quality
System that requires all organizations performing work for EPA to develop and operate
management processes and structures for assuring that data or information collected are of the
needed and expected quality for their desired use.
This document provides the development and content requirements for Quality
Management Plans for organizations that conduct environmental data operations for EPA through
contracts, assistance agreements, and interagency agreements; however, it may be used by EPA as
well. It contains the same requirements as Chapter 3 of the EPA Order 5360 Al (2000), EPA
! Quality Manual for Environmental Programs, for EPA organizations.
N
t This document is one of the U.S. Environmental Protection Agency Quality System Series
J documents. These documents describe the EPA policies and procedures for planning,
^ implementing, and assessing the effectiveness of the Quality System. Questions regarding this
document or other Quality System Series documents should be directed to the Quality Staff:
i
•: U.S. EPA
Quality Staff (28 11R)
Washington, DC 20460
^ Phone: (202) 564-6830
? FAX: (202)565-2441
YS e-mail: quality@epa.gov
"?'
•^ Copies of EPA Quality System Series documents may be obtained from the Quality Staff directly
^ or by downloading them from its Home Page:
^, www.epa.gov/quality
^
n
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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.
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TABLE OF CONTENTS
Page
CHAPTER 1. INTRODUCTION 1
1.1 BACKGROUND 1
1.2 QUALITY MANAGEMENT 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 4
CHAPTER 2. QUALITY MANAGEMENT PLAN REQUIREMENTS 5
2.1 POLICY 5
2.2 PURPOSE 5
2.3 APPLICABILITY 5
2.4 GENERAL CONTENT AND DETAIL REQUIREMENTS 5
2.4.1 General Content 5
2.4.2 Level of Detail 6
2.5 QUALITY MANAGEMENT PLAN PREPARATION 6
2.6 QUALITY MANAGEMENT PLAN SUBMISSION AND APPROVAL 7
2.7 QUALITY MANAGEMENT PLAN REVISIONS 7
CHAPTER 3. QUALITY MANAGEMENT PLAN ELEMENTS 9
3.1 CONTENT REQUIREMENTS 9
3.2 MANAGEMENT AND ORGANIZATION 10
3.3 QUALITY SYSTEM COMPONENTS 11
3.4 PERSONNEL QUALIFICATION AND TRAINING 12
3.5 PROCUREMENT OF ITEMS AND SERVICES 12
3.6 DOCUMENTS AND RECORDS 13
3.7 COMPUTER HARDWARE AND SOFTWARE 14
3.8 PLANNING 15
3.9 IMPLEMENTATION OF WORK PROCESSES 16
3.10 ASSESSMENT AND RESPONSE 17
3.11 QUALITY IMPROVEMENT 18
REFERENCES 19
APPENDIX A. TERMS AND DEFINITIONS A-l
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CHAPTER 1
INTRODUCTION
1.1 BACKGROUND
The U.S. Environmental Protection Agency (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. Furthermore, as EPA is
increasingly involved in the use of environmental technology for pollution control and waste
clean-up, the use of particular technologies is often specified in permits and regulations. If
decision makers are to have the necessary confidence in the quality of environmental data used to
support their decisions or that environmental technology successfully performed its intended role,
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 organizations are required to document their
quality system in a Quality Management Plan through EPA Order 5360.1 A2, Policy and
Program Requirements for the Mandatory Agency-wide Quality System (EPA 2000). Non-EPA
organizations funded by EPA are required to document their quality system in a Quality
Management Plan (or equivalent document)1 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.
A Quality Management Plan documents how an organization structures its quality system
and describes its quality policies and procedures, criteria for and areas of application, and roles,
responsibilities, and authorities. It also describes an organization's policies and procedures for
implementing and assessing the effectiveness of the quality system. This document describes the
elements of a quality system that must be documented in a Quality Management Plan to comply
with EPA requirements.
'An equivalent document may not be called a Quality Management Plan but still would document an
organization's quality system and address the required quality management practices described in this document.
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This requirements document presents specifications and instructions for the information
that must be contained in a Quality Management Plan for organizations conducting environmental
programs funded by EPA. The document also discusses the procedures for review, approval,
implementation, and revision of Quality Management Plans. Users of this document should
assume that all of the elements described herein are required in a Quality Management Plan unless
otherwise directed by EPA.
1.2 QUALITY MANAGEMENT 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 that are funded
by EPA. Components of this 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. Quality system
documentation (e.g., the Quality Management Plan) is a key component of the EPA Quality
System as shown in Figure 1.
EPA policy is based on the national consensus standard, ANSI/ASQC E4-1994,
Specifications and Guidelines for Environmental Data Collection and Environmental
Technology Programs. The ANSI/ASQC E4-1994 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. The 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
Quality Assurance Project Plan (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 A requirements of the standard.
The Quality Management Plan may be viewed as the 'umbrella' document under which
individual projects are conducted. The Quality Management Plan is then supported by project-
specific QA Project Plans. A QA Project Plan is the 'blueprint' by which individual projects
involving environmental data are implemented and assessed and how specific quality assurance
(QA) and quality control (QC) activities will be applied during a particular project. EPA
requirements for QA Project Plans are defined in EPA Requirements for Quality Assurance
Project Plans (QA/R-5) (EPA 2001). 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.
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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)
Conduct Study/
. Experiment >
1
Standard
Operating
Procedures
i
Technical
Assessments
PLANNING
i
IMPLEMENTATION
ASSESSMENT
Defensible Products and Decisions
Figure 1. EPA Quality System Components and Tools
EPA QA/R-2
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1.3 THE GRADED APPROACH AND THE EPA QUALITY SYSTEM
Implementation of the EPA Quality System is based on the principle of graded approach.
This principle recognizes that a 'one size fits all' approach to quality requirements will not work
in an organization as diverse as EPA so managerial controls are applied according to the scope of
the program and/or the intended use of the outputs from a process. 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. 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. The specific application of the graded approach
principle to Quality Management Plans is described in Section 2.4.2.
1.4 INTENDED AUDIENCE
This document specifies the requirements for developing a Quality Management Plan 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 their Quality Management Plans since this document is clearer and more
user-friendly than the equivalent requirements defined in Section 3.3 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 3.2 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
EPA has issued a checklist for reviewing Quality Management Plans that can be used to
verify if the requirements defined in this document are satisfied. This checklist is available on the
Quality Staff website, www.epa.gov/quality/tools-org.htmWqmp.
1.7 SUPERSESSION
This document replaces QAMS-004/80, Interim Guidelines and Specifications for
Preparing Quality Assurance Program Plans (EPA 1980) in its entirety.
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CHAPTER 2
QUALITY MANAGEMENT PLAN REQUIREMENTS
2.1 POLICY
Quality systems supporting environmental programs involving environmental data or
technology conducted by EPA organizations or by organizations funded by EPA shall be covered
by an Agency-approved Quality Management Plan.
2.2 PURPOSE
A Quality Management Plan is a management tool that documents an organization's
quality system for planning, implementing, documenting, and assessing the effectiveness of
activities supporting environmental data operations and other environmental programs. The
Quality Management Plan is used to demonstrate conformance to Part A requirements of
ANSI/ASQC E4-1994.
2.3 APPLICABILITY
These requirements apply to all organizations conducting environmental programs funded
by EPA that acquire, generate, compile, or use environmental data and technology. These
requirements apply to all work performed through contracts, cooperative agreements, interagency
agreements, State-EPA agreements, State, local, and Tribal Financial Assistants/Grants (including
Performance Partnership Grants and Agreements), Research Grants, and in response to statutory
or regulatory requirements and consent agreements. These requirements shall be negotiated into
interagency agreements, including sub-agreements, and, in some cases, included in enforcement
consent agreements and orders. Where specific Federal regulations require the application of QA
and QC activities (see Section 1.1), Quality Management Plans shall be prepared, reviewed, and
approved in accordance with the specifications contained in this document unless explicitly
superseded by regulation.
2.4 GENERAL CONTENT AND DETAIL REQUIREMENTS
2.4.1 General Content
The Quality Management Plan documents the quality management practices which are
critical to a quality system. Specific Quality Management Plan content requirements are described
in Chapter 3. Each organization should evaluate these requirements for applicability to their
quality system. Where a particular element is not relevant, an explanation of why it is not relevant
must be provided in the Quality Management Plan. Also, if the Quality Management Plan
preparer or EPA organization sponsoring the work determines that additional quality management
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elements are useful or necessary for an adequate quality system, these elements should be
discussed in the Quality Management Plan.
2.4.2 Level of Detail
The Quality Management Plan should describe a Quality System that is designed to
support the objectives of the organization. The level of effort expended to develop a Quality
Management Plan should be based on the scope of the program. For example, large grants to a
State government may require a comprehensive quality system and Quality Management Plan,
whereas smaller grants for programs with relatively less significant impacts may require less
substantial documentation.
The Quality Management Plan must be sufficiently inclusive, explicit, and readable to
enable both management and staff to understand the priority which management places on QA
and QC activities, the established quality policies and procedures, and their respective quality-
related roles and responsibilities. The Quality Management Plan must be written so that an
assessment of the suitability and effectiveness of the organization's quality system can be
accomplished. Such assessments will enable management to determine if the quality system meets
the needs of the organization. The Quality Management Plan should be focused on the processes
and procedures used to plan, implement, and assess the programs to which it is applied, and must
include definitions of appropriate authorities and responsibilities for managers and staff.
2.5 QUALITY MANAGEMENT PLAN PREPARATION2
An organization's senior manager is responsible for assuring the preparation of a Quality
Management Plan to cover all environmental programs supported or undertaken by the
organization. Senior management, i.e., the executives and managers who are responsible and
accountable for mission accomplishment and overall operations of the organization, is responsible
for ensuring that the Quality Management Plan is prepared and that the quality system
documented in the Quality Management Plan satisfies all EPA policy requirements and meets all
statutory, contractual, and assistance agreement requirements for EPA work.
While senior management is responsible for the preparation of the Quality Management
Plan, the actual preparation may be assigned to the organization's staff so long as it is assured that
all managers support the effort; for example, the preparation of the Quality Management Plan may
be directed by the QA Manager of the organization. However, it is essential that all management
levels understand fully the content of the Quality Management Plan and concur with its
implementation.
2Specific preparation, submission, review, and approval requirements for EPA organizations are contained in
Section 3.2 of EPA Order 5360 Al (EPA 2000) as these represent internal EPA policy.
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2.6 QUALITY MANAGEMENT PLAN SUBMISSION AND APPROVAL
The Quality Management Plan must be approved and signed by the senior management of
the organization. This will certify that the organization has conducted an internal review of the
Quality Management Plan and that management has concurred with its contents.
When a Quality Management Plan is required either by statute, contractual requirement, or
assistance agreement condition, the Quality Management Plan must be submitted for review and
approval to the EPA official responsible for the work. The EPA official may include the
contracting officer's representative (such as the project officer, work assignment manager, or
delivery order project office), the award official, and the EPA QA Manager. For example, the
review and approval of a State Quality Management Plan that has been submitted as part of a
request for an assistance agreement may be performed by the QA Manager of the office awarding
the assistance agreement.
EPA approval of a Quality Management Plan will be valid for no more than five years for
State, local, and Tribal governments or the length of the extramural agreement for all other
extramural agreement holders. The period for which a Quality Management Plan is valid is
defined in the Quality Management Plan of the EPA organization sponsoring the work.
2.7 QUALITY MANAGEMENT PLAN REVISIONS
Each organization shall review its Quality Management Plan at least annually to reconfirm
the suitability and effectiveness of the approved quality management practices. The process of
developing, annually reviewing, and revising (as needed) the Quality Management Plan provides
an opportunity for management and staff to clarify roles and responsibilities, address problem
areas, and institutionalize improvements. Having an accurate Quality Management Plan at all
times is an essential element in every quality system, thus changes in QA policy and procedures
shall be documented in the Quality Management Plan in a timely fashion.
In general, a copy of any Quality Management Plan revision(s) made during the year
should be submitted to EPA as a report when such changes occur. However, if significant
changes have been made to the quality system that affect the performance of work for the
Agency, it may be necessary to re-submit the entire Quality Management Plan to EPA for re-
approval. Conditions requiring the revision of an approved Quality Management Plan include:
• expiration of the five-year life span of the Quality Management Plan;
• major changes in mission and responsibilities, such as changes in the delegation
status of a program;
re-organization of existing functions that affect programs covered by the Quality
Management Plan; and
• assessment findings requiring corrective actions and response.
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All appropriate personnel in the organization performing work covered by the scope of the
Quality Management Plan shall be notified of changes to the quality system and the Quality
Management Plan to keep them informed of the current requirements. This practice should also
include active sub-contractors for relevant work.
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CHAPTER 3
QUALITY MANAGEMENT PLAN ELEMENTS
3.1 CONTENT REQUIREMENTS
The Quality Management Plan documents management practices, including QA and QC
activities, used to ensure that the results of technical work are of the type and quality needed for
their intended use. Accordingly, the Quality Management Plan documents:
the mission and quality policy of the organization;
• the specific roles, authorities, and responsibilities of management and staff with
respect to QA and QC activities;
• the means by which effective communications with personnel actually performing
the work are assured;
• the processes used to plan, implement, and assess the work performed;
the process by which measures of effectiveness for QA and QC activities will be
established and how frequently effectiveness will be measured; and
the continual improvement based on lessons learned from previous experience.
The Quality Management Plan reflects the organization's commitment to quality management
principles and practices, tailored, when appropriate, by senior management to meet the
organization's needs.
The elements to be addressed in a Quality Management Plan include: management and
organization; quality system description; personnel qualifications and training; procurement of
items and services; documentation and records; computer hardware and software; planning;
implementation of work processes; assessment and response; and quality improvement. Specific
requirements for each of these elements are described below in Sections 3.2 through 3.11. Items
specific to Quality Management Plans developed by EPA organizations under EPA Order 5360.1
A2 (EPA 2000) are noted by "EPA Quality Management Plans." Organizations funded by EPA
do not have to address these EPA-specific items.
It is preferable, but not necessary, that the Quality Management Plan address the
specifications in the same order as presented below to ensure uniformity and a consistent and
complete review. If an existing, approved Quality Management Plan adequately addresses each of
these topics, it should not be rewritten simply to conform to the outline provided here.
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3.2 MANAGEMENT AND ORGANIZATION
Purpose - To document the overall policy, scope, applicability, and management responsibilities
of the organization's quality system.
Specifications - Provide the following:
• an approval page for the signatures of the organization's management and QA
manager. The approval page may be part of a title page or a separate sheet
following the title page. If EPA approval of the Quality Management Plan is
required, the approval page shall include a section for the signature of the EPA
official (see Section 2.6). For EPA Quality Management Plans3, the approval page
shall contain the signatures of the organization's senior manager, senior line
management (as appropriate), the QA Manager, the Director of the Quality Staff,
and the Assistant Administrator of the Office of Environmental Information;
• a statement of the organization's policy on quality assurance, including:
the importance of QA and QC activities to the organization and why,
the general objectives and goals of the quality system, and
the policy for resource allocation for the quality system (EPA Quality
Management Plans must discuss personnel, intramural and extramural
funding, and travel resources);
• an organization chart that identifies all of the components of the organization and,
in particular, the organizational position and lines of reporting for the QA Manager
(or similar position such as a Quality Manager) and any QA staff;
• a discussion of the authorities of the QA Manager and any other QA staff that also:
documents the organizational independence of the QA Manager from
groups generating, compiling, and evaluating environmental data, and
indicates how the organization will ensure that QA personnel will have
access to the appropriate levels of management in order to plan, assess, and
improve the organization's quality system;
• a discussion of the technical activities or programs that are supported by the
quality system including:
the specific programs that require quality management controls,
Organizations funded by EPA do not have to address these EPA-specific elements.
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where oversight of delegated, contracted, or other extramural programs is
needed to assure data quality, and
where and how internal coordination of QA and QC activities among the
group's organizational units needs to occur;
a discussion of how management will assure that applicable elements of the quality
system are understood and implemented in all environmental programs; and
• a discussion of the organization's process for resolving disputes regarding quality
system requirements, QA and QC procedures, assessments, or corrective actions
(requirement for EPA Quality Management Plans only).
3.3 QUALITY SYSTEM COMPONENTS
Purpose - To document how an organization manages its quality system and defines the primary
responsibilities for managing and implementing each component of the system.
Specifications - Provide the following:
a description of the organization's quality system that includes the principal
components of the system and the roles and implementation responsibilities of
management and staff with regards to these components. These components
include, but are not limited to:
quality system documentation
annual reviews and planning
management assessments
training
systematic planning of projects
project-specific quality documentation
project and data assessments;
• a list of the tools for implementing each component of the quality system. These
tools include, but are not limited to:
Quality Management Plans (quality system documentation),
Quality Systems Audits (management assessments),
Training Plans (training),
QA Project Plan (project-specific quality documentation),
Data Verification and Validation (data assessments);
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a list of any components of the organization that develop Quality Management
Plans (or equivalent document) in support of the organization's Quality System
and the review and approval procedures for such documentation; and
• a discussion of how roles and responsibilities for the principal components of the
Quality System are incorporated into performance standards (requirement for EPA
Quality Management Plans only).
3.4 PERSONNEL QUALIFICATION AND TRAINING
Purpose - To document the procedures for assuring that all personnel performing work for an
organization have the necessary skills to effectively accomplish their work.
Specifications - Provide the following:
• a statement of the policy regarding training for management and staff;
• a description of the process(es), including the roles, responsibilities, and authorities
of management and staff, for:
identifying, ensuring, and documenting that personnel have and maintain
the appropriate knowledge, skill, and statutory, regulatory, professional or
other certifications, accreditations, licenses, or other formal qualification
necessary, and
identifying the need for retraining based on changing requirements.
3.5 PROCUREMENT OF ITEMS AND SERVICES
Purpose - To document the procedures for purchased items and services that directly affect the
quality of environmental programs.
Specifications -
Describe or reference the process(es), including the roles, responsibilities, and authorities
of management and staff, pertaining to all appropriate procurement documents or extramural
agreements, including grants, cooperative agreements, and contracted and subcontracted
activities, involving or affecting environmental programs, for:
• reviewing and approving procurement documents (and any changes to these
documents) to ensure that procurement documents are accurate, complete, and
clearly describe:
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the item or service needed,
the associated technical and quality requirements,
the quality system elements for which the supplier is responsible, and
how the supplier's conformance to the customer's requirements will be
verified;
• review and approval of all applicable responses to solicitations to ensure that these
documents:
satisfy all technical and quality requirements, and
provide evidence of the supplier's capability to satisfy EPA quality system
requirements as defined in the extramural agreement or applicable Federal
Regulation (requirement for EPA Quality Management Plans only);
• ensuring that procured items and services are of acceptable quality, including the
review of objective evidence of quality for applicable items and services furnished
by suppliers and subcontractors, source selection, source inspections, supplier
audits, and examination of deliverables;
review and approval procedures for mandatory quality-related documentation
(e.g., Quality Management Plans or QA Project Plans) from suppliers (requirement
for EPA Quality Management Plans only);
• policies and criteria for delegations of EPA authority to review and approve
mandatory quality-related documentation (e.g., Quality Management Plans or QA
Project Plans) from suppliers consistent with Chapter 2.2 of EPA Order 5360 Al
(requirement for EPA Quality Management Plans only); and
ensuring that EPA quality-related contracting policies, as defined by the Federal
Acquisition Regulations, Office of Federal Procurement Policy, and the EPA
Contracts Management Manual [EPA Order 1900 (EPA 1998)], are satisfied
(requirement for EPA Quality Management Plans only).
3.6 DOCUMENTS AND RECORDS
Purpose - To document appropriate controls for quality-related documents and records
determined to be important to the mission of the organization.
Specifications - Describe or reference the process(es), including the roles, responsibilities, and
authorities of management and staff, for:
• identifying quality-related documents and records (both printed and electronic)
requiring control;
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preparing, reviewing for conformance to technical and quality system
requirements, approving, issuing, using, authenticating, and revising documents
and records;
• ensuring that records and documents accurately reflect completed work;
• maintaining documents and records including transmittal, distribution, retention
(including retention times), access, preservation (including protection from
damage, loss, and deterioration), traceability, retrieval, removal of obsolete
documentation, and disposition;
• ensuring compliance with all applicable statutory, regulatory, and EPA
requirements for documents and records [EPA Quality Management Plans shall
ensure compliance with EPA Order 2160 (EPA 1984) and EPA Directive 2100,
Chapter 10 (EPA 1998)]; and
• establishing and implementing appropriate chain of custody and confidentiality
procedures for evidentiary records.
3.7 COMPUTER HARDWARE AND SOFTWARE
Purpose - To document how the organization will ensure that computer hardware and software
satisfies the organization's requirements.
Specifications - Describe or reference the process(es), including the roles, responsibilities, and
authorities of management and staff, for:
developing, installing, testing (including verification and validation), using,
maintaining, controlling, and documenting computer hardware and software used
in environmental programs to ensure it meets technical and quality requirements
and directives from management [EPA Quality Management Plan specifications
must be consistent with EPA Directive 2100 (EPA 1998)];
• assessing and documenting the impact of changes to user requirements and/or the
hardware and software on performance;
• evaluating purchased hardware and software to ensure it meets user requirements
and complies with applicable contractual requirements and standards;
ensuring that data and information produced from, or collected by, computers
meet applicable information resource management requirements and standards; and
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• ensuring that applicable EPA requirements for information resources management
are addressed [EPA Directive 2100 (EPA 1998)] including security and privacy
requirements (requirement for EPA Quality Management Plans only).
Computer software covered by this requirement includes, but is not limited to, design, data
handling, data analysis, modeling of environmental processes and conditions, operations, or
process control of environmental technology system (including automated data acquisition and
laboratory instrumentation), data bases containing environmental data.
3.8 PLANNING
Purpose - To document how individual data operations will be planned within the organization to
ensure that data or information collected are of the needed and expected quality for their desired
use.
Specifications - Describe or reference the process(es), including the roles, responsibilities, and
authorities of management and staff, for:
• planning environmental data operations using a systematic planning process4 which
includes:
the identification and involvement of the project manager, sponsoring
organization and responsible official, project personnel, stakeholders,
scientific experts, etc. (e.g., all customers and suppliers);
a description of the project goal, objectives, and questions and issues to be
addressed;
the identification of project schedule, resources (including budget),
milestones, and any applicable requirements (e.g., regulatory and
contractual requirements);
the identification of the type and quantity of data needed and how the data
will be used to support the project's objectives;
the specification of performance criteria for measuring quality;
4EPA has developed a systematic planning process called the Data Quality Objectives (DQO) Process [See the
EPA Guidance for the Data Quality Objectives Process (QA/G-4) (EPA 2000)]. While not mandatory, the DQO
Process is the recommended planning approach for many EPA data collection activities.
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the specification of needed QA and QC activities to assess the quality
performance criteria (e.g., QC samples for both the field and laboratory,
audits, technical assessments, performance evaluations, etc.);
a description of how, when, and where the data will be obtained (including
existing data) and identification of any constraints on data collection; and
a description of how the acquired data will be analyzed (either in the field
or the laboratory), evaluated (i.e., QA review, verification, validation), and
assessed against its intended use and the quality performance criteria;
developing, reviewing, approving, implementing, and revising a QA Project Plan or
equivalent planning document [see EPA Requirements for Quality Assurance
Project Plans (QA/R-5) (EPA 2001)]; and
evaluating and qualifying data collected for other purposes or from other sources,
including the application of any statistical methods, for a new use.
3.9 IMPLEMENTATION OF WORK PROCESSES
Purpose - To document how work processes will be implemented within the organization to
ensure that data or information collected are of the needed and expected quality for their desired
use.
Specifications - Describe or reference the process(es), including the roles, responsibilities, and
authorities of management and staff for:
ensuring that work is performed according to approved planning and technical
documents;
• identification of operations needing procedures (e.g., standardized, special, or
critical operations), preparation (including form, content, and applicability),
review, approval, revision, and withdrawal of these procedures; and policy for use;
and
controlling and documenting the release, change, and use of planned procedures,
including any necessary approvals, specific times and points for implementing
changes, removal of obsolete documentation from work areas, and verification that
the changes are made as prescribed.
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3.10 ASSESSMENT AND RESPONSE
Purpose - To document how the organization will determine the suitability and effectiveness of
the implemented quality system and the quality performance of the environmental programs to
which the quality system applies.
Specifications - Describe or reference the process(es), including the roles, responsibilities, and
authorities of management and staff, pertaining to both management and technical assessments
for:
• assessing the adequacy of the quality system at least annually;
• planning, implementing, and documenting assessments and reporting assessment
results to management including how to select an assessment tool, the expected
frequency of their application to environmental programs, and the roles and
responsibilities of assessors;
determining the level of competence, experience, and training necessary to ensure
that personnel conducting assessments are technically knowledgeable, have no real
or perceived conflict of interest, and have no direct involvement or responsibility
for the work being assessed;
• ensuring that personnel conducting assessments have sufficient authority, access to
programs, managers, documents, and records, and organizational freedom to:
identify both quality problems and noteworthy practices,
propose recommendations for resolving quality problems, and
independently confirm implementation and effectiveness of solutions;
• management's review and response to findings;
• identifying how and when corrective actions are to be taken in response to the
findings of the assessment, ensuring corrective actions are made promptly,
confirming the implementation and effectiveness of any corrective action, and
documenting (including the identification of root causes, the determination of
whether the problem is unique or has more generic implications, and
recommendation of procedures to prevent recurrence) such actions; and
addressing any disputes encountered as a result of assessments.
Available assessment tools include quality systems audits, management systems reviews, peer
reviews, technical reviews, performance evaluations, data quality assessments, readiness reviews,
technical systems audits, and surveillance.
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3.11 QUALITY IMPROVEMENT
Purpose - To document how the organization will improve the organization's quality system.
Specifications - Identify who (organizationally) is responsible for identifying, planning,
implementing, and evaluating the effectiveness of quality improvement activities and describe the
process to ensure continuous quality improvement, including the roles and responsibilities of
management and staff, for:
• ensuring that conditions adverse to quality are:
prevented,
identified promptly including a determination of the nature and extent of
the problem,
corrected as soon as practical, including implementing appropriate
corrective actions and actions to prevent reoccurrence,
documenting all corrective actions, and
tracking such actions to closure;
encouraging staff at all levels to establish communications between customers and
suppliers, identify process improvement opportunities, and identify and offer
solutions to problems.
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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 (1999), Information Resources Management Policy Manual, U.S.
Environmental Protection Agency, Washington, DC.
EPA Order 1900 (February 1998), Contracts Management Manual, U.S. Environmental
Protection Agency, Washington, DC.
EPA Order 2160 (July 1984), Records Management Manual, U.S. Environmental Protection
Agency, Washington, DC.
EPA Order 5360 Al (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
Quality Assurance Program, U.S. Environmental Protection Agency, Washington, DC.
U.S. Environmental Protection Agency, 2001. EPA Requirements for Quality Assurance Project
Plans (QA/R-5), EPA/240/B-01/003, Office of Environmental Information.
U.S. Environmental Protection Agency, 2000. Guidance for the Data Quality Objectives Process
(QA/G-4), EPA/600/R-96/055, Office of Environmental Information.
U.S. Environmental Protection Agency, 1980. Interim Guidelines and Specifications for
Preparing Quality Assurance Program Plans, Q AMS-004/80, Office of Research and
Development.
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APPENDIX A
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.
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.
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.
environmental data operations - work performed to obtain, use, or report information
pertaining to environmental processes and conditions.
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
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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.
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.
inspection - examination or measurement of an item or activity to verify conformance to specific
requirements.
management - those individuals directly responsible and accountable for planning, implementing,
and assessing work.
management system - a structured, non-technical system describing the policies, objectives,
principles, organizational authority, responsibilities, accountability, and implementation plan of an
organization for conducting work and producing items and services.
management systems review - the qualitative assessment of a data collection operation and/or
organization(s) to establish whether the prevailing quality management structure, policies,
practices, and procedures are adequate for ensuring that the type and quality of data needed are
obtained.
objective evidence - any documented statement of fact, other information or record, either
quantitative or qualitative, pertaining to the quality of an item or activity, based on observations,
measurements, or tests which can be verified.
organization - a company, corporation, firm, enterprise, or institution, or part thereof, whether
incorporated or not, public or private, that has its own functions and administration.
peer review - a documented critical review of work by qualified individuals (or organizations)
who are independent of those who performed the work, but are collectively equivalent in technical
expertise. A peer review is conducted to ensure that activities are technically adequate,
competently performed, properly documented, and satisfy established technical and quality
requirements. The peer review is an in-depth assessment of the assumptions, calculations,
extrapolations, alternate interpretations, methodology, acceptance criteria, and conclusions
pertaining to specific work and of the documentation that supports them.
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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.
process - a set of interrelated resources and activities which transforms inputs into outputs.
Examples of processes include analysis, design, data collection, operation, fabrication, and
calculation.
quality - the totality of features and characteristics of a product or service that bear on its ability
to meet the stated or implied needs and expectations of the user.
quality assurance (QA) - an integrated system of management activities involving planning,
implementation, documentation, assessment, reporting, and quality improvement to ensure that a
process, item, or service is of the type and quality needed and expected by the client.
quality assurance project plan - 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.
quality control (QC) - the overall system of technical activities that measures the attributes and
performance of a process, item, or service against defined standards to verify that they meet the
stated requirements established by the customer; operational techniques and activities that are
used to fulfill requirements for quality.
quality improvement - a management program for improving the quality of operations. Such
management programs generally entail a formal mechanism for encouraging worker
recommendations with timely management evaluation and feedback or implementation.
quality management - that aspect of the overall management system of the organization that
determines and implements the quality policy. Quality management includes strategic planning,
allocation of resources, and other systematic activities (e.g., planning, implementation,
documentation, and assessment) pertaining to the quality system.
quality management plan - a document that describes the quality system in terms of the
organizational structure, functional responsibilities of management and staff, lines of authority,
and required interfaces for those planning, implementing, and assessing all activities conducted.
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.
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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.
self-assessment - assessments of work conducted by individuals, groups, or organizations directly
responsible for overseeing and/or performing the work.
specification - a document stating requirements and which refers to or includes drawings or other
relevant documents. Specifications should indicate the means and the criteria for determining
conformance.
standard operating procedure (SOP) - a written document that details the method for an
operation, analysis, or action with thoroughly prescribed techniques and steps, and that is
officially approved as the method for performing certain routine or repetitive tasks.
supplier - any individual or organization furnishing items or services or performing work
according to a procurement document or financial assistance agreement. This is an all-inclusive
term used in place of any of the following: vendor, seller, contractor, subcontractor, fabricator, or
consultant.
surveillance (quality) - continual or frequent monitoring and verification of the status of an
entity and the analysis of records to ensure that specified requirements are being fulfilled.
technical review - a documented critical review of work that has been performed within the state
of the art. The review is accomplished by one or more qualified reviewers who are independent
of those who performed the work, but are collectively equivalent in technical expertise to those
who performed the original work. The review is an in-depth analysis and evaluation of
documents, activities, material, data, or items that require technical verification or validation for
applicability, correctness, adequacy, completeness, and assurance that established requirements
are satisfied.
technical systems audit - 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.
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