October 27, 1998
MEMORANDUM
SUBJECT: Review of External Review Draft Final of EPA Requirements for
Quality Management Plans (QA/R-2)
FROM: Nancy W. Wentworth, Director /s/
Quality Assurance Division (8724R)
TO: EPA QA Managers
External Reviewers
Attached for your review is the External Review Draft Final, EPA
Requirements for Quality Management Plans (QA/R-2), dated October 1998.
This document formally defines the EPA requirements for Quality Management
Plans (QMPs) developed by non-EPA organizations. EPA policy (EPA Order 5360.1
CHG 1, July 1998) requires that all organizations conducting environmental
programs by or on behalf of EPA establish and implement effective quality systems
to support these programs. Part of this policy is the requirement to document these
quality systems in an EPA-approved QMP.
This external review is the last step before this document is finalized and
invoked in EPA financial agreements to satisfy the requirements of this policy.
Earlier versions of R-2 have been widely circulated inside and outside of the Agency
which have yielded many helpful comments. This draft final incorporates revisions
necessary to assure conformance with EPA Order 5360.1 CHG 1.
The QMP is a management "blueprint" for applying quality assurance and
quality control to environmental programs. The QMP describes an organization's
quality system for planning, implementing, and assessing the effectiveness of
activities supporting environmental data operations and other environmental
programs. The development, review, approval, and implementation of the QMP is
required by the mandatory Agency-wide Quality System defined by the Order. This
policy requires all organizations performing environmental programs for EPA to
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develop and implement procedures and processes to ensure that data collected or
compiled for use in Agency decision making are of the type and quality needed and
expected for their intended use.
EPA's Agency-wide Quality System is based on the national consensus
standard, ANSI/ASQC E4-1994, Specifications and Guidelines for Environmental
Data Collection and Environmental Technology Programs. The ANSI/ASQC
E4-1994 defines the requisite management and technical elements necessary to
develop and implement a quality system for an organization's environmental
programs. The ANSI/ASQC E4 standard requires a QMP or Quality Manual, and
the requirements given in this document are consistent with the E4 standard. EPA
has invoked ANSI/ASQC E4-1994 through 48 CFR Part 46 for contracts (to be
issued shortly) and 40 CFR Part 30 for grants and cooperative agreements to
institutions of higher education, hospitals, and other non-profit recipients of
financial assistance. The current quality assurance requirements in 40 CFR Part
31, for State, local, and Tribal governments, allows EPA flexibility in defining an
acceptable QA program. It is EPA policy that an "acceptable QA program" is one
that conforms to the E4 standard. While 40 CFR Part 31 does not currently invoke
E4, it is expected to be revised in the future to specifically invoke E4. Compliance
with the requirements of this document will be considered consistent with the QMP
requirements of E4. In the meantime, the Office of Grants and Debarment will
provide standard terms and conditions that address QMP documentation
requirements for assistance agreements covered by 40 CFR Part 31.
Please note that this document will not undergo a review through the Federal
Register since EPA is invoking this document as a method for complying with the
requirements of E4. Also note that the content of this document has undergone an
Agency-wide review and has been issued as internal policy as Chapter 4 of EPA
Order 5360, The EPA Quality Manual for Environmental Programs (July 1998). In
addition, this document will be supplemented by the EPA Guidance for Quality
Management Plans (QA/G-2) (under development) which provides suggestions on
preparing, reviewing, and implementing QMPs. Copies of any of these references
and additional copies of this review document are available on the world wide web
at "es.epa.gov/ncerqa/qa/index.html" or may be obtained directly from EPA's Quality
Assurance Division (202/564-6830).
In order to complete a comprehensive peer review of this document, I ask that
you carefully review the document to answer the following questions:
Does R-2 conform to the requirements defined by ASQC/ANSI
E4-1994?
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Are there any quality management processes missing from the
document?
Is the text readable and clear in its meaning? If the text is unclear,
please provide alternative language to clarify the current text.
Please submit your comments by November 30, 1998 to:
QMP Requirement Comments
Quality Assurance Division (8724R)
U.S. Environmental Protection Agency
401 M. Street, SW *
Washington, DC 20460
In addition, comments may be faxed to (202) 565-2441, ATTN: QMP Requirements
Comments or e-mailed to ord-qad@epa.gov.
I appreciate your time spent in reviewing this document. Your input is very
important. I strongly believe that these requirements will assist both EPA and our
extramural agreement holders in ensuring that data collected or complied for EPA
are of the type and quality needed to support timely, cost-effective decision making.
Attachment
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EPA REQUIREMENTS FOR
QUALITY MANAGEMENT PLANS
EPA QA/R-2
United States Environmental Protection Agency
Quality Assurance Division (8724R)
401 M Street, SW
Washington, DC 20460
EXTERNAL REVIEW DRAFT FINAL
OCTOBER 1998
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FOREWORD
The U.S. Environmental Protection Agency (EPA) has developed the Quality
Management Plan (QMP) as a means of documenting how an organization will plan, implement,
and assess the effectiveness of quality assurance (QA) and quality control (QC) 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
Quality System. The development, review, approval, and implementation of the QMP 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. The QMP is
an integral part of the fundamental principles of Quality Management which form the foundation
of the Agency's Quality System.
This document contains essentially the same requirements as Chapter 3 of the EPA Order
5360 (July 1998), EPA Quality Manual for Environmental Programs, for EPA organizations.
This document provides the QMP requirements in an external publication primarily for non-EPA
organizations that conduct environmental data operations in behalf of EPA through contracts,
assistance agreements, and interagency agreements; however, it may be used by EPA as well. A
companion document, EPA Guidance for Quality Management Plans (QA/G-2), is currently
being developed to provide guidance on satisfying the requirements of this document.
This document is one of the U.S. Environmental Protection Agency Quality System Series
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:
U.S. EPA
Quality Assurance Division (8724R)
401 M Street, SW
Washington, DC 20460
Phone: (202) 564-6830
FAX: (202)565-2441
e-mail: ord-qad@epa.gov
Copies of EPA Quality System Series documents may be obtained from the Quality
Assurance Division or by downloading them from the QAD Home Page at:
URL Address: http://es.epa.gov/ncerqa/qa/index.html
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ACKNOWLEDGMENTS
This document reflects the collaborative efforts of many quality management
professionals throughout the Environmental Protection Agency, who are participating in the
challenge for continuous improvement in quality systems supporting environmental programs.
These individuals, representing the EPA Regional Offices, Program Office organizations, and
research and development centers and laboratories, provide a diverse and broad range of needs
and experiences in environmental data collection programs. Their contributions and the
comprehensive reviews provided by members of the EPA quality community during the
development of this document are greatly appreciated.
11
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TABLE OF CONTENTS
Page
CHAPTER 1. INTRODUCTION 1
1.1 BACKGROUND 1
1.2 QMPs, THE EPA QUALITY SYSTEM, AND ANSI/ASQC E4 2
1.3 SUPERSESSION 3
1.4 PERIOD OF APPLICABILITY 3
1.5 ADDITIONAL RESOURCES 3
CHAPTER 2. QUALITY MANAGEMENT PLAN PREPARATION, SUBMISSION,
REVIEW, AND APPROVAL 5
2.1 POLICY 5
2.2 PURPOSE 5
2.3 APPLICABILITY 5
2.4 GENERAL CONTENT AND DETAIL REQUIREMENTS 5
2.5 QMP PREPARATION RESPONSIBILITY 6
2.6 QMP SUBMISSION AND EPA APPROVAL 7
2.7 QMP REVISIONS 7
CHAPTER 3. QUALITY MANAGEMENT PLAN REQUIREMENTS 9
3.1 CONTENT REQUIREMENTS 9
3.2 MANAGEMENT AND ORGANIZATION 10
3.3 QUALITY SYSTEM AND DESCRIPTION 11
3.4 PERSONNEL QUALIFICATION AND TRAINING 11
3.5 PROCUREMENT OF ITEMS AND SERVICES 11
3.6 DOCUMENTATION AND RECORDS 12
3.7 COMPUTER HARDWARE AND SOFTWARE 12
3.8 PLANNING 13
3.9 IMPLEMENTATION OF WORK PROCESSES 15
3.10 ASSESSMENT AND RESPONSE 15
3.11 QUALITY IMPROVEMENT 16
REFERENCES 18
APPENDIX A. TERMS AND DEFINITIONS A-l
in
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(This page has been left blank intentionally.)
IV
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CHAPTER 1
INTRODUCTION
1.1 BACKGROUND
Environmental programs conducted in behalf of the'U.S. Environmental Protection
Agency (EPA) involve many diverse activities that address complex environmental issues. The
EPA annually spends several hundred million dollars in the collection of environmental data' for
scientific research and regulatory decision-making. In addition, the regulated community may
spend as much as an order of magnitude more each year to respond to Agency compliance
requirements. Furthermore, EPA is increasingly involved in the use of environmental
technology for pollution control and waste clean-up, often specifying the use of particular
technologies in permits and regulations.
Environmental data are critical inputs to decisions involving the protection of the public
and the environment from the adverse effects of pollutants from natural and man-made sources.
Such sources may include waste operations and industrial discharges. Similarly, environmental
data are key inputs to decisions and actions pertaining to environmental protection efforts in air,
land, forests, fresh water, oceans, estuaries, and ground water. The success of environmental
technology in abating pollutant emissions and effluent discharges, or in remediating waste sites,
depends largely on the design of the technology, its proper fabrication and construction, and its
proper operation. Consequently, quality assurance (QA) and quality control (QC) practices are
needed to ensure that environmental technology successfully performs its intended role.
It is EPA policy (EPA Order 5360.1 CHG 1) that all organizations conducting
environmental programs by or on behalf of EPA establish and implement effective quality
systems to support those programs. Part of this quality system is the requirement to document
their quality system2 in an EPA-approved Quality Management Plan (QMP). This requirement is
externalized through several mechanisms, including
° 48 CFR Part 46, Federal Acquisition Regulations, for contractors;
e 40 CFR Parts 30, 31, and 35 for assistance agreement recipients;
'Environmental data include any parameters or pieces of information collected or produced from measurements,
analyses, or models of environmental processes and conditions and effects of pollutants on human health and the
ecology, including results from laboratory analyses or from experimental systems representing such processes and
conditions.
2A quality system is a structured and documented management system describing the policies and procedures for
ensuring that work processes, products, or services satisfy stated expectations or specifications. A more complete
definition is given in the appendix.
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° and other mechanisms, such as consent agreements in enforcement actions.
The QMP is the blueprint for how the organization will plan, implement, and assess its
quality system for the environmental work to be performed. The QMP defines an organization's
QA-related:
° policies and procedures,
e criteria for and areas of application, and,
° roles, responsibilities, and authorities.
1.2 QMPs, THE EPA QUALITY SYSTEM, AND ANSI/ASQC E4
EPA Order 5360.1 CHG 1 establishes a mandatory Agency-wide Quality System that
applies to all organizations performing work for EPA as well as to EPA. (The authority for the
requirements defined by the Order are contained in the applicable regulations for extramural
agreements.) These organizations must ensure that data collected for the characterization of
environmental processes and conditions are of the appropriate type and quality for their intended
use and that environmental technologies are designed, constructed, and operated according to
defined expectations. The QMP is a key component of the EPA Quality System as shown in
Figure 1.
EPA policy is based on the national consensus standard, ANSI/ASQC E4-1994,
Specifications and Guidelines for Environmental Data Collection and Environmental
Technology Programs. The ANSI/ASQC E4-1994 provides the basis for the quality system for
an organization's environmental programs. The document provides the requisite management
and technical area elements necessary for developing and implementing a quality system. The
document first describes the quality management elements that are generally common to
environmental problems, regardless of their technical scope. The document then discusses the
specifications and guidelines that apply to project-specific environmental activities involving the
generation, collection, analysis, evaluation, and reporting of environmental data. Finally, the
document contains the minimum specifications and guidelines that apply to the design,
construction, and operation of environmental technology.
The ANSI/ASQC E4 standard requires two principal forms of quality system
documentation: the QMP and the quality assurance project plan (QAPP). The QMP documents
how an organization structures its quality system, defines and assigns QA and QC
responsibilities, and describes the processes and procedures used to plan, implement, and assess
the effectiveness of the quality system. The QMP may be viewed as the "umbrella" document
under which individual projects are conducted. The requirements defined by EPA for QAPPs are
given in EPA Requirements for Quality Assurance Project Plans (QA/R-5) (EPA 1998).
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1.3 SUPERSESSION
This document replaces QAMS-004/80, Interim Guidelines and Specifications for
Preparing Quality Assurance Program Plans (EPA 1980) in its entirety.
1.4 PERIOD OF APPLICABILITY
Per EPA Order 5360, this document shall be valid for a period of five years from the
official date of publication. After five years, this document shall either be reissued, revised, or
removed from the EPA Quality System.
1.5 ADDITIONAL RESOURCES
Guidance on preparing QMPs may be found in a companion document, EPA Guidance
for Quality Management Plans (QA/G-2) (in progress). This guidance discusses the application
of the QMP requirements given in this document to both EPA and non-EPA organizations and
provides examples of how the QMP requirements may be satisfied.
In addition to this guidance, the EPA Quality Assurance Division has developed a
standard operating procedure (SOP) for reviewing EPA QMPs, which may be applied to
extramural QMPs as well. Copies of this SOP are available on the QAD website
(URL:http://es.epa.gov/ncerqa/qa/index.html). The same SOP is included an appendix to the
QA/G-2 document described above.
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Consensus Standards
ANSI/ASQC E4
ISO 9000 Series
External EPA Policies
Contracts - 48 CFR Part 46
Assistance Agreements - 40 CFR
Parts 30, 31, and 35
Internal EPA Policies
EPA Order 5360.1 CHG 1
EPA Quality Manual (5360)
EPA Program &
Regional Policy
QA Annual Report
and Work Plan
(Internal EPA)
Management
Assessments
Defensible
Products and
Decisions
Figure 1. The EPA Quality System
EPA QA/R-2
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CHAPTER 2
QUALITY MANAGEMENT PLAN
PREPARATION, SUBMISSION, REVIEW, AND APPROVAL
2.1 POLICY
All work performed by extramural organizations on behalf of EPA that involves the
acquisition of environmental data generated from direct measurement activities, collected from
other sources, or compiled from computerized data bases and information systems shall be
covered by an Agency-approved QMP. Work performed on behalf of EPA includes activities
performed under contracts, assistance agreements, or interagency agreements. These
requirements will be negotiated into interagency agreements, including sub-agreements, and, in
some cases, included in enforcement consent agreements and orders.
2.2 PURPOSE
Quality management begins with the QMP. The QMP is the management "blueprint" for
applying QA and QC to environmental programs. The QMP defines the unique quality system
for planning, implementing, and assessing the effectiveness of activities supporting
environmental data operations and other environmental programs. The QMP provides the
principal basis for management reviews of an organization's quality system.
2.3 APPLICABILITY
These QMP requirements apply to all organizations having environmental programs that
acquire, generate, or compile environmental data and that are performed on behalf of EPA.
These operations include work performed through contracts, cooperative agreements, interagency
agreements, State-EPA agreements, State, local, and Tribal Financial Assistants/Grants, Research
Grants, and in response to statutory or regulatory requirements and consent agreements. These
requirements will be negotiated into interagency agreements, including sub-agreements, and, in
some cases, included in enforcement consent agreements and orders. Where specific Federal
regulations require QA and QC, QMPs shall be prepared, reviewed, and approved in accordance
with the specifications contained in this document unless explicitly superseded by the regulation.
2.4 GENERAL CONTENT AND DETAIL REQUIREMENTS
This document describes the quality management practices which are considered to be
critical to a quality system and which must be addressed and documented in a QMP. Some
elements are mandatory to ensure consistency across EPA-related quality systems. Other
elements may be mission-specific and may not apply to every organization. Each organization
should evaluate these key elements to see if they are applicable to their quality system. Where a
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particular element is not relevant, a brief explanation of why it is not relevant should be provided
in the QMP. On the other hand, if the QMP preparer determines that additional quality
management elements are useful or necessary for an adequate quality system, these elements
should be developed and discussed in the QMP.
The QMP is a management tool whose contents may be appropriately tailored to the
needs of the organization and which defines how its quality management objectives will be
attained. The QMP must be sufficiently inclusive, explicit, and readable to enable managers and
supervisors to understand the priority which management places on QA, the established QA
policies and procedures, and their respective QA roles. The QMP must be constructed and
written so that an assessment of the suitability and effectiveness of the organization's quality
system following implementation can be accomplished. Such assessments will enable
management to determine whether or not the quality system is meeting the needs of the
organization's mission and goals for its environmental programs. In practice, the QMP 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. The level of detail in the QMP should be based on a common sense, graded
approach3 that establishes QA and QC requirements commensurate with the importance of the
work, the available resources, and the unique needs of the organization.
2.5 QMP PREPARATION RESPONSIBILITY
An organization's top manager is responsible for assuring the preparation of a QMP to
cover all environmental programs supported or undertaken by the organization. The term senior
management refers to executives and managers who are responsible and accountable for mission
accomplishment and overall operations of the organization. Senior management is responsible
for ensuring that the QMP is prepared and that the quality system documented in the QMP meets
all statutory, contractual, and assistance agreement requirements for EPA work.
While senior management is responsible for the preparation of the QMP, the physical
preparation may be assigned to the organization's staff so long as it is assured that all managers
participate in and support the effort. For example, the preparation of the QMP may be directed
by the QA Manager of the organization; however, it is essential that all management levels
understand fully the content of the QMP and concur with its implementation.
3A graded approach to QA and QC bases the level of managerial controls on the intended use of the results and
the degree of confidence needed in the quality of the results.
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2.6 QMP SUBMISSION AND EPA APPROVAL
The QMP must be approved and signed by the senior management of the organization
preparing the QMP. This will certify that the organization has conducted an internal review of
the QMP and that management has concurred with its contents.
When review and approval of a QMP by EPA is required either by statute, contractual
requirement, or assistance agreement condition, the QMP must be submitted for review to the
EPA organization responsible for the work to be performed. For example, the review of a State
QMP that has been submitted as part of a request for an assistance agreement will be performed
by the Region or Office making the decision on the assistance request. EPA will approve those
QMPs that include acceptable QA policies, procedures, administrative criteria, and management
systems for key QA elements including systematic planning; preparation, review, and approval
of QAPPs; review and approval of other, applicable QMPs (such as for subcontractors); use of
Standard Operating Procedures (SOPs); use of management and technical assessments; and
oversight of delegated programs.
EPA approval of a QMP will be valid for five years for State and local governments or
the length of the extramural agreement for all other extramural agreement holders. EPA policy
requires that each approved QMP be reviewed at least annually to reconfirm the suitability and
effectiveness of the approved quality management practices. Revisions to an EPA-approved
QMP resulting from a review are covered in Section 2.7.
2.7 QMP REVISIONS
EPA policy requires that all quality systems supporting agency quality systems be
reviewed at least annually by their organizations to reconfirm the suitability and effectiveness of
the approved quality management practices. This assessment must also include an evaluation of
the effectiveness of the QMP. The process of developing and then annually updating the QMP
provides an opportunity for management and staff to clarify roles and responsibilities, address
problem areas, and acknowledge successes so that they may be fostered and rewarded. Having
an accurate QMP at all times is an essential element in every quality system. It is EPA policy
that changes in QA policy and procedures shall be documented in timely fashion by QMP
revisions.
In general, a copy of any QMP revision(s) made during the year should be submitted to
EPA as a report when such changes occur. In some cases, however, it may be necessary to re-
submit the entire QMP if significant changes have been made to the quality system that
significantly affects the performance of work for the Agency. It is recommended that all
appropriate personnel in the organization performing work covered by the scope of the QMP be
notified of all changes to the quality system and the QMP to keep them informed of the current
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requirements. This practice should also be extended to include active sub-contractors for
relevant work.
EPA recognizes that the QMP has broader applicability for an organization than just the
period of performance for an extramural agreement. While the value to the organization of
having a quality system conforming to ANSI/ASQC E4 may extend beyond the organization's
relationship with EPA, the QMP must be valid for the full period of performance for any work
performed on behalf of EPA and all EPA requirements for review and assessment must be met.
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CHAPTER 3
QUALITY MANAGEMENT PLAN REQUIREMENTS
3.1 CONTENT REQUIREMENTS
The QMP describes how the organization plans and implements the necessary quality
management practices, including QA and QC, to help management to ensure that the results of
technical work are of the type and quality needed for their intended use.
Accordingly, the QMP shall document:
° 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,
e the process(es) used to plan, implement, and assess the work performed,
° the process by which measures of effectiveness for QA and QC will be
established and how frequently effectiveness will be measured, and
• continual improvement based on lessons learned from previous experience.
The QMP must reflect the organization's commitment to quality management principles and
practices, tailored, when appropriate, by senior management to meet the organization's needs.
For the purposes of uniformity and to ensure a consistent and complete review of the QMP, it is
preferable, but not necessary, that the QMP address the specifications in the same order as
presented below. If an existing, approved QMP adequately addresses each of these topics, but in
a different order, it should not be rewritten simply to conform to the outline provided here.
There are 10 elements to be addressed in a QMP: management and organization; quality
system and 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 within
each of these program elements are in sections 3.2 through 3.11. If an organization believes that
an element is not applicable to its quality system, then it must state why this is the case when
submitting a QMP for EPA approval.
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3.2 MANAGEMENT AND ORGANIZATION
Provide the following management and organizational items:
• a statement of the organization's policy on quality assurance, including:
the importance of QA and QC to the organization and why,
the general objectives/goals of the quality system, and
the policy for resource allocation for the quality system;
° 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 (and any QA staff) that documents the independence of the QA Manager
from groups generating, compiling, and evaluating environmental data;
° a discussion of the responsibilities and authorities of the QA Manager and any
other QA staff;
° a discussion of the technical activities or programs that are supported by the
quality system and to which it applies; that is, the specific programs that require
extensive quality management controls; where oversight of delegated, contracted,
or other extramural programs is needed to assure data quality; and where internal
coordination of QA and QC among the group's organizational units needs to
occur;
e a discussion of the QA and QC roles and responsibilities of management,
technical staff, and any other staff, and how these roles and responsibilities are
incorporated into assessments of performance;
° a discussion of how management will assure that applicable elements of the
quality system are understood and implemented in all environmental programs;
and
• an approval page for the signatures of the management, the QA manager of the
organization, and for the responsible EPA official. The EPA official may include
the contracting officer's representative (for example, the project officer for
contracts, the work assignment manager for work assignments, or the delivery
order project office for delivery orders), the award official (for assistance
agreements), and the EPA QA manager. This approval page may be part of a title
page or a separate sheet following the title page.
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3.3 QUALITY SYSTEM AND DESCRIPTION
Discuss the principal components or "tools" comprising the quality system and how and
when they are to be applied to individual projects and tasks. These components include, but are
not limited to:
QMPs
• management assessments (self and independent)
• systematic planning processes
QAPPs
» standard operating procedures
° technical assessments (self and independent)
° data quality assessments
The discussion shall include the roles and responsibilities of all management and staff
involved in planning and implementing the quality system.
3.4 PERSONNEL QUALIFICATION AND TRAINING
State the policy regarding training for management and staff. Describe the processes and
the management and/or staff responsible for:
° identifying statutory, regulatory, or professional certifications that may be
required to perform certain operations; and
° identifying, designing, performing, and documenting technical, quality, and
project management training.
Describe how staff proficiency in critical technical disciplines is maintained and documented.
3.5 PROCUREMENT OF ITEMS AND SERVICES
Describe and discuss the organization's process for ensuring that contracted and
subcontracted activities that involved or affect environmental programs produce results of
acceptable quality, including, as appropriate:
° procurement source evaluation and selection,
° evaluation of objective evidence of quality furnished by the supplier,
° source inspections,
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0 supplier audits, and
e examination of deliverables.
3.6 DOCUMENTATION AND RECORDS
Describe or reference the process:
• for identifying quality-related documents and records requiring control;
° for handling documents and records to assure their accessibility, protection from
damage and deterioration, and means of retention, including discussion of the
roles and responsibilities for management and staff;
° by which all technical guidance documents are prepared, reviewed, approved,
issued, used, and revised; and
° by which all planning documents (e.g., QAPPs, Sampling and Analysis Plans) are
prepared, reviewed, approved, issued, used, and revised; and
• for ensuring compliance with all statutory, contractual, and assistance agreement
requirements for records from environmental programs and that provides adequate
preservation of key records necessary to support the mission of the organization.
Documents and records, including revisions, must be reviewed for conformance with the quality
system requirements and approved by authorized personnel for general use.
Describe or reference the management process that ensures that records accurately reflect
completed work and/or fulfill statutory and contractual requirements. The maintenance of
records includes defining requirements and responsibilities for record transmittal, distribution,
retention, protection, preservation, traceability, disposition, and retrievability. Identify how the
disposition of records, in accordance with regulatory requirements, schedules, or directives from
management, is accomplished.
3.7 COMPUTER HARDWARE AND SOFTWARE
Describe or reference:
° the process for ensuring that computer hardware used in environmental programs
meets technical requirements and quality expectations;
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° how changes to hardware shall be controlled to assess the impact of the change on
performance;
° the process for developing computer software, for validating, verifying, and
documenting the software for its use, and for assuring that the software meets the
requirements of the user;
« how purchased software is evaluated to meet user requirements and to comply
with applicable contractual requirements and standards; and
° describe or reference the process for ensuring that data and information produced
from or collected by computers meet applicable information resource
management requirements and standards.
These descriptions shall include the roles and responsibilities assigned to management and staff.
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, and data bases.
3.8 PLANNING
3.8.1 Systematic Planning
Environmental data operations shall be planned using a systematic planning process that
encompasses principles based on the scientific method. The planning process shall use a
common sense, graded approach to ensure that the level of detail in planning is commensurate
with the importance and intended use of the work and the available resources. Minimum
elements of a systematic planning approach that must be documented in the QMP include:
° identification and involvement of the project manager, sponsoring organization
and responsible official, project personnel, stakeholders, scientific experts, etc.
(e.g., all customers and suppliers);
« description of the project goal, objectives, and questions and issues to be
addressed;
0 identification of project schedule, resources (including budget), milestones, and
any applicable requirements (e.g., regulatory and contractual requirements);
0 identification of the type of data needed and how the data will be used to support
the project's objectives;
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» determination of the quantity of data needed and specification of performance
criteria for measuring quality;
• description of how, when, and where the data will be obtained (including existing
data) and identification of any constraints on data collection;
s 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.);
° description of how the acquired data will be analyzed (either in the field or the
laboratory), evaluated (i.e., QA review, validation, verification), and assessed
against its intended use and the quality performance criteria.
A systematic planning process shall ensure that all organizations and/or parties who
contribute to the quality of the environmental program or use the results are identified and that
they participate in this process. The planning process shall also provide for direct
communication between the customer and the supplier to ensure that there is a clear
understanding by all participants of the needs and expectations of the customer and the product
or results to be provided by the supplier.
EPA has developed a systematic planning process called the Data Quality Objectives
(DQO) Process (EPA 1994). The DQO Process is based on the scientific method and employs
statistical methods to create project planning results. The resulting designs are expressed in
terms of acceptable allowed error in the project results. While not mandatory, this process is the
recommended planning approach for many EPA data collection activities.
Describe the process for planning environmental programs, including identification of
who is responsible and how general project planning is documented. Describe who uses the
planning "tools" (as defined in the Quality System Description section of the QMP) and the roles
and responsibilities of all management and staff involved in planning.
3.8.2 Quality Assurance Project Plans
Discuss how the results of planning for environmental data operations shall be
documented in a QAPP (EPA 1998). The process for developing, reviewing, submitting for
approval, implementing, and revising a QAPP, must be described in this section of the QMP.
Describe or discuss how data obtained from sources outside EPA that did not use an
EPA-approved QAPP (or equivalent planning document) for data collection shall be evaluated
and qualified for use. Discuss the process for qualifying such data, including the application of
any statistical methods used.
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3.9 IMPLEMENTATION OF WORK PROCESSES
Describe the process of how and by whom work shall be implemented within the
organization for:
° ensuring that work is performed according to plan;
e developing and implementing procedures for appropriate routine, standardized,
special, or critical operations, including those that address, but are not limited to:
identification of operations needing procedures;
preparation of procedures, including form, content, and applicability; and
review and approval of procedures; and
° use of QA and QC "tools" such as standard operating procedures (SOPs).
Describe how appropriate measures for controlling the release, change, and use of
planned procedures are implemented. These measures shall provide for the 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.
To help to assure consistency in common procedures, SOPs are encouraged for
appropriate routine, standardized, or special/critical operations. The QMP shall describe the
organization's process for identifying the need for SOPs, the process for developing SOPs, and
the policy for using SOPs. The QMP shall also describe the process by which SOPs are
reviewed for initial and subsequent use.
3.10 ASSESSMENT AND RESPONSE
Describe how and by whom assessments of environmental programs are planned,
conducted, and evaluated. Describe the process by which management chooses a particular
assessment tool, and the expected frequency of their application to environmental programs.
Available assessment tools include audits, data quality assessments, management systems
reviews, peer reviews and technical reviews, performance evaluations, readiness reviews,
technical systems audits, and surveillance. Senior management shall assess (at least annually)
the adequacy of the quality system.
Discuss or address the following items pertaining to management and technical
assessments:
° how the process for the planning, scheduling, and implementation of assessments
works, as well as how the organization shall respond to needed changes;
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° responsibilities, levels of participation, and authorities for all management and
staff participating in the assessment process; and
* how, when, and by whom actions shall be taken in response to the findings of the
assessment, and how the effectiveness of the response shall be determined.
Describe how the level of competence, experience, and training necessary to ensure the
capability of personnel conducting assessments are determined. Personnel conducting
assessments shall be qualified, based on project-specific requirements, to perform the assigned
assessment. Management is responsible for choosing the assessors, defining acceptance criteria,
approving audit procedures and check lists, and identifying goals prior to initiation of an
assessment. Assessors shall be technically knowledgeable with no real or perceived conflict of
interest. If the assessors are chosen from within the organization, they must have no direct
involvement or responsibility for the work being assessed, except for self-assessments.
Describe how personnel conducting assessments shall have sufficient authority, access to
programs and managers, access to documents and records, and organizational freedom to identify
quality problems; identify and cite noteworthy practices that may be shared with others to
improve the quality of their operations and products; propose recommendations for resolving
quality problems; and independently confirm implementation and effectiveness of solutions.
Describe how assessment results are documented, reported to, and reviewed by
management. Describe how management shall respond to the results (or findings) and
recommendations from assessments in a timely manner. When conditions needing corrective
action are identified, the appropriate response must be made promptly. Indicate how follow-up
action shall be taken and documented to confirm the implementation and effectiveness of the
response action. Describe how disputes, if encountered, as a result of assessments are addressed
and by whom.
3.11 QUALITY IMPROVEMENT
Describe how the organization shall detect and prevent quality problems and for ensuring
continuous quality improvement, including:
° the management process and identify who (organizationally) is responsible for
identifying, planning, implementing, and evaluating the effectiveness of quality
improvement activities;
° a corrective action program to ensure that conditions adverse to quality are
identified promptly and corrected as soon as practical.
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Corrective actions shall include the identification of root causes of problems, the
determination of whether the problem is unique or has more generic implications, and a
recommendation of procedures to prevent recurrence.
Describe how staff at all levels are encouraged to identify and establish communications
among customers and suppliers, identify process improvement opportunities, identify problems,
and offer solutions to those problems.
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REFERENCES
Title 40, Part 30, Code of Federal Regulations, "Grants and Agreements With Institutions of
Higher Education, Hospitals, and Other Non-Profit Organizations."
Title 40, Part 31, Code of Federal Regulations, "Uniform Administrative Requirements for
Grants and Cooperative Agreement to State and Local Governments."
Title 40, Part 35, Code of Federal Regulations, "State and Local Assistance."
Title 48, Part 46, Code of Federal Regulations, "Federal Acquisition Regulations."
ANSI/ASQC E4-1994, Specifications and Guidelines for Quality Systems for Environmental
Data Collection and Environmental Technology Programs, American National Standard,
January 1995.
EPA Order 5360, July 1998. EPA Quality Manual for Environmental Programs, U.S.
Environmental Protection Agency, Washington, DC.
EPA Order 5360.1 CHG 1 (July 1998), Policy and Program Requirements to Implement the
Mandatory Quality Assurance Program, U.S. Environmental Protection Agency,
Washington, DC.
U.S. Environmental Protection Agency, 1998. EPA Requirements for Quality Assurance Project
Plans (QA/R-5), EPA/600/R-98/???, Office of Research and Development.
U.S. Environmental Protection Agency, 1994. Guidance for the Data Quality Objectives
Process (QA/G-4), EPA/600/R-96/055, Office of Research and Development.
U.S. Environmental Protection Agency, 1980. Interim Guidelines and Specifications for
Preparing Quality Assurance Program Plans, QAMS-004/80, Office of Research and
Development.
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APPENDIX A
TERMS AND DEFINITIONS
activity - an all-inclusive term describing a specific set of operations or related tasks to be
performed, either serially or in parallel (e.g., research and development, field sampling,
analytical operations, equipment fabrication), that in total result in a product or service.
assessment - the evaluation process used to measure the performance or effectiveness of a
system and its elements. As used here, assessment is an all-inclusive term used to denote any of
the following: audit, performance evaluation, management systems review, peer review,
inspection, or surveillance.
audit (quality) - a systematic and independent examination to determine whether quality
activities and related results comply with planned arrangements and whether these arrangements
are implemented effectively and are suitable to achieve objectives.
completeness - a measure of the amount of valid data obtained from a measurement system
compared to the amount that was expected to be obtained under correct, normal conditions.
contractor - any organization or individual that contracts to furnish services or items or perform
work.
client - any individual or organization for whom items or services are furnished or work
performed in response to defined requirements and expectations.
data quality assessment (DQA) - a statistical and scientific evaluation of the data set to
determine the validity and performance of the data collection design and statistical test, and to
determine the adequacy of the data set for its intended use.
data quality objectives (DQO) process - a systematic planning tool to facilitate the planning of
environmental data collection activities. Data quality objectives are the qualitative and
quantitative outputs from the DQO Process.
design - specifications, drawings, design criteria, and performance requirements. Also the result
of deliberate planning, analysis, mathematical manipulations, and design processes.
entity - that which can be individually described and considered, such as a process, product,
item, organization, or combination thereof.
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environmental conditions - the description of a physical medium (e.g., air, water, soil,
sediment) or biological system expressed in terms of its physical, chemical, radiological, or
biological characteristics.
environmental data -any measurements or information that describe environmental processes,
location, or conditions; ecological or health effects and consequences; or the performance of
environmental technology. For EPA, environmental data include information collected directly
from measurements, produced from models, and compiled from other sources such as data bases
or the literature.
environmental data operations - work performed to obtain, use, or report information
pertaining to environmental processes and conditions.
environmental monitoring - the process of measuring or collecting environmental data.
environmental processes - manufactured or natural processes that produce discharges to, or that
impact, the ambient environment.
environmental programs - work or activities involving the environment, including but not
limited to: characterization of environmental processes and conditions; environmental
monitoring; environmental research and development; the design, construction, and operation of
environmental technologies; and laboratory operations on environmental samples.
environmental technology - an all-inclusive term used to describe pollution control devices and
systems, waste treatment processes and storage facilities, and site remediation technologies and
their components that may be utilized to remove pollutants or contaminants from or prevent them
from entering the environment. Examples include wet scrubbers (air), soil washing (soil),
granulated activated carbon unit (water), and filtration (air, water). Usually, this term will apply
to hardware-based systems; however, it will also apply to methods or techniques used for
pollution prevention, pollutant reduction, or containment of contamination to prevent further
movement of the contaminants, such as capping, solidification or vitrification, and biological
treatment.
financial assistance - the process by which funds are provided by one organization (usually
government) to another organization for the purpose of performing work or furnishing services or
items. Financial assistance mechanisms include grants, cooperative agreements, and government
interagency agreements.
finding - an assessment conclusion that identifies a condition having a significant effect on an
item or activity. An assessment finding may be positive or negative, and is normally
accompanied by specific examples of the observed condition.
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graded approach - the process of basing the level of application of managerial controls applied
to an item or work according to the intended use of the results and the degree of confidence
needed in the quality of the results.
guideline - a suggested practice that is non-mandatory in programs intended to comply with a
standard.
independent assessment - an assessment performed by a qualified individual, group, or
organization that is not a part of the organization directly performing and accountable for the
work being assessed.
inspection - examination or measurement of an item or activity to verify conformance to specific
requirements.
item - an all-inclusive term used in place of the following: appurtenance, facility, sample,
assembly, component, equipment, material, module, part, product, structure, subassembly,
subsystem, system, unit, documented concepts, or data.
management - those individuals directly responsible and accountable for planning,
implementing, and assessing work.
management system - a structured non-technical system describing the policies, objectives,
principles, organizational authority, responsibilities, accountability, and implementation plan of
an organization for conducting work and producing items and services.
management systems review (MSR) - the qualitative assessment of a data collection operation
and/or organization(s) to establish whether the prevailing quality management structure, policies,
practices, and procedures are adequate for ensuring that the type and quality of data needed are
obtained.
method - a body of procedures and techniques for performing an activity (e.g., sampling,
chemical analysis, quantification) systematically presented in the order in which they are to be
executed.
objective evidence - any documented statement of fact, other information, or record, either
quantitative or qualitative, pertaining to the quality of an item or activity, based on observations,
measurements, or tests which can be verified.
observation - an assessment conclusion that identifies a condition (either positive or negative)
which does not represent a significant impact on an item or activity. An observation may
identify a condition which does not yet cause a degradation of quality.
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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.
performance evaluation (PE) - 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 (QAPP) - 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,
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allocation of resources, and other systematic activities (e.g., planning, implementation,
documentation, and assessment) pertaining to the quality system.
quality management plan (QMP) - a document that describes the quality system in terms of the
organizational structure, functional responsibilities of management and staff, lines of authority,
and required interfaces for those planning, implementing, and assessing all activities conducted.
quality system - a structured and documented management system describing the policies,
objectives, principles, organizational authority, responsibilities, accountability, and
implementation plan of an organization for ensuring quality in its work processes, products
(items), and services. The quality system provides the framework for planning, implementing,
documenting, and assessing work performed by the organization and for carrying out required
QA and QC.
readiness review - a systematic, documented review of the readiness for the start-up or
continued use of a facility, process, or activity. Readiness reviews are typically conducted before
proceeding beyond project milestones and prior to initiation of a major phase of work.
record - a completed document that provides objective evidence of an item or process. Records
may include photographs, drawings, magnetic tape, and other data recording media.
research (applied) - a process, the objective of which is to gain knowledge or understanding
necessary for determining the means by which a recognized and specific need may be met.
research (basic) - a process, the objective of which is to gain fuller knowledge or understanding
of the fundamental aspects of phenomena and of observable facts without specific applications
toward processes or products in mind.
scientific method - the principles and processes regarded as necessary for scientific
investigation, including rules for concept or hypothesis formulation, conduct of experiments, and
validation of hypotheses by analysis of observations.
self-assessment - assessments of work conducted by individuals, groups, or organizations
directly responsible for overseeing and/or performing the work.
service - the result generated by activities at the interface between the supplier and the customer,
and by supplier internal activities to meet customer needs. Such activities in environmental
programs include design, inspection, laboratory and/or field analysis, repair, and installation.
specification - a document stating requirements and which refers to or includes drawings or
other relevant documents. Specifications should indicate the means and the criteria for
determining conformance.
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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 (TSA) - a thorough, systematic, on-site, qualitative audit of facilities,
equipment, personnel, training, procedures, record keeping, data validation, data management,
and reporting aspects of a system.
traceability - the ability to trace the history, application, or location of an entity by means of
recorded identifications. In a calibration sense, traceability relates measuring equipment to
national or international standards, primary standards, basic physical constants or properties, or
reference materials. In a data collection sense, it relates calculations and data generated
throughout the project back to the requirements for quality for the project.
user - an organization, group, or individual that utilizes the results or products from
environmental programs or a customer for whom the results or products were collected or
created.
validation - confirmation by examination and provision of objective evidence that the particular
requirements for a specific intended use are fulfilled. In design and development, validation
concerns the process of examining a product or result to determine conformance to user needs.
verification - confirmation by examination and provision of objective evidence that specified
requirements have been fulfilled. In design and development, verification concerns the process
of examining a result of a given activity to determine conformance to the stated requirements for
that activity.
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