Quality Management Plan and
Quality Assurance Project Plan
Seminar
U.S. Environmental Protection Agency
Region 6 - Dallas, Texas
Office of Quality Assurance
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TABLE OF CONTENTS
July 16, 2001
Agenda
Course Objectives
Quality Management Plans (QMP)
EPA QA/R-2
QMP Exercise #1
QMP Exercise #2
Part C of ANSI/ASQ E4-1994
Quality Assurance Project Plans
EPA QA/R-5
QAPP Exercise #1
QAPP Exercise #2
Terms and Definitions
QA Office Information
Page Number
1
3
5
7
31
55
99
129
131
167
185
247
253
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NOTES
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AGENDA
Day 1 - Morning Session: 8:00 AM - 12:00 PM
8:00 - 8:30 AM Introduction
8:30 - 9:00 AM Quality Management Plans - General
9:00 - 10:00 AM EPA QMP Requirements
10:00 - 12:00 PM QMP Practical Exercise #1
Lunch: 12:00 - 12:30 PM
Afternoon Session: 12:30 - 4:30 PM
12:30 - 1:00 PM Critique Exercise # 1
1:00 - 2:00 PM QMP Practical Exercise # 2
2:00 - 2:30 PM Critique Practical Exercise # 2
2:30 - 4:30 PM ANSI/ASQC E4-1994 Part C
Day 2 - Morning Session: 8:00 AM - 12:00 PM
8:00 - 9:00 AM QAPPs - General
9:00 - 10:00 AM EPA QAPP Requirements
10:00 - 12:00 PM QAPP Practical Exercise #1
Lunch: 12:00 - 12:30 PM
Afternoon Session: 12:30 - 4:30 PM
12:30 - 1:30 PM Critique Exercise # 1
1:30 - 3:00 PM QAPP Practical Exercise # 2
3:00 - 4:00 PM Critique Practical Exercise # 2
4:00 - 4:30 PM Wrap-Up & Final Comments
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NOTES
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COURSE OBJECTIVES
By the end of this course, participants will be able to:
- understand in detail the 10 elements of a Quality Management Plan;
- effectively evaluate the elements of a Quality Management Plan;
- determine the approvability of a Quality Management Plan;
- understand the linkage between Quality Management Plans and Quality Assurance
Project Plans;
- define the review and approval process for QA Plans in EPA Region 6;
- understand in detail the 24 elements of a Quality Assurance Project Plan;
- effectively evaluate the elements of a Quality Assurance Project Plan;
- determine the approvability of a Quality Assurance Project Plan; and
- understand the relationship of the EPA's QA System to ANSI/ASQ E-4.
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NOTES
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QUALITY MANAGEMENT PLANS
Definition;
Quality Management Plan (QMP) - a formal 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.
What it does:
- Ensures senior management commitment and involvement;
- Provides a blueprint of the quality program;
- Describes roles and responsibilities;
- Defines requirements for QA Project Plans;
- Provides a benchmark for evaluating progress;
- Satisfies CFR requirements for documenting quality program.
Criteria:
EPA Requirements for Quality Management Plans. EPA QA/R-2
(Replacing Guidance and Specifications for Preparing Quality Assurance
Program Plans. OAMS-004/80
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NOTES
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United States Office of Environmental EPA/240/B-01/002
Environmental Protection Information March 2001
Agency Washington, DC 20460
v>EPA 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
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.
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 the Quality Staff:
U.S. EPA
Quality Staff (2811R)
Washington, DC 20460
Phone: (202) 564-6830
FAX: (202)565-2441
e-mail: quality@epa.gov
Copies of EPA Quality System Series documents may be obtained from the Quality Staff directly
or by downloading them from its Home Page:
www.epa.gov/quality
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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
CHAPTERS. 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 '.'.'.".".'.'.'.'.'.'.'.'. \*
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 ofPart 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
Supporting System Elements
(e.g.. Procurements,
Computer Hardware/Software)
Training/Communication
(e.g.. Training Plan,
Conferences)
Systematic
Planning
(e.g., DQO Process)
^S. Experiment
I
i
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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13
Final
March 2001
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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.
Specific 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 Q A 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
hi 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
Final
EPA QA/R-2 14 March 2001
24
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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;
*EPA 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.
Final
EPA QA/R-2 15 March 2001
25
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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.
Final
EPAQA/R-2 16 March 2001
26
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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.
Final
EPA QA/R-2 17 March 2001
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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.
Final
EPAQA/R-2 18 March 2001
28
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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, 'Tederal 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, QAMS-004/80, Office of Research and
Development.
Final
EPAQA/R-2 19 March 2001
29
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(This page has been left blank intentionally.)
Final
EPAQA/R-2 20 March 2001
30
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QMP PRACTICAL EXERCISE #1
In small groups, we will review a "Good Example" of a "Bad Example" of a Quality
Management Plan submitted by the Commonwealth of East Carolina's Water Commission
(ECWC), for it's Marine and Estuarine Division. The ECWC has total responsibility for all
Environmental work on surface, subsurface and coastal waterways in the mythical
Commonwealth of East Carolina. Since this "Bad Example" is comprised of bits and pieces of
QMPs submitted from, several organizations and states the name of the state has been changed
to protect the guilty.
Spending a limited amount of time, as defined by the instructor, review the sections identified
by the instructor using EPA QA/R-2 as the review criteria.
31
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NOTES
32
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QUALITY MANAGEMENT PLAN
FOR
MARINE AND ESTUARINE ENVIRONMENTAL
MONITORING AND REMEDIAL ACTION
SUBMITTED BY EAST CAROLINA
WATER COMMISSION
33
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TABLE OF CONTENTS
SECTION NO. HEADING REVISION PAGEff
N/A Tide Page 5 N/A
N/A Table of Contents 5 i
N/A Quality Management Plan
Approval Page 5 ii
1.0 Quality Management and
Organization 5 1
2.0 Quality System and Description 5 3
3.0 Personnel Qualifications
and Training 5 5
4.0 Procurement of Items and
Services 5 6
5.0 Quality Documentation and
Records 5 7
6.0 Use of Automated Data
Processing System 5 8
7.0 Quality Planning 5 10
8.0 Quality Implementation of
Work Processes 5 11
9.0 Quality Assessment and Response 5 12
10.0 Quality Improvement 5 14
Appendices
App A Appendix A-Defmitions 5 A-l
App B ECWC SOP #5 3
App C ECWC Directive # 5-92 N/A
34
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Quality Management Plan for work to be performed by, or implemented by, the East Carolina
Water Commission, for all efforts involving Marine and Estuarine Environmental Monitoring
and Remedial Action, in the State and Coastal Waters of the Commonwealth of East Carolina.
East Carolina Water Commission Document Control Number OMP-1996-ME Div.-l
EPA Region 6 QTRAK #_
Plan Prepared By:
Susan Daigle, ECWC Marine &
Division Quality Assurance Manager
ECWC Concurre
Breedon, ECWC Central Laboratory
division Director
Gflmore, ECWC DataTrocessing
Division Chief
Paul Cronin, ECWC Field Operations
Division Chief
ECWC Appn
arryl Rqfyale, Marine and Estuarine
Divi&ion Director
Shelia Meyers, Qua^ty Manager ECWC
EPA Approvals:
Date:
Date:
Date:
Date
: 9//Z/96
Date:
Date:
Date:
Barry S\^mitter, ECWC Commissioner
Alva L. Smith, 6EN-XQ
Regional Quality Assurance Officer
Date:
35
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Section No._
Revision No..
. 12. 1996
Page 1 of 17
1. . QUALITY MANAGEMENT AND ORGANIZATION
1.1 EC WC Marine and Estuarine Division Mission
The mission of ECWC Marine and Estuarine Division is to monitor and protect the environment
to the extent outlined by Commonwealth of East Carolina Statutory Law and the delegated
responsibilities from the U.S. Code of Federal Regulations that U.S. EPA has empowered the
ECWC. A good decision for ECWC is one that follows both the spirit and letter of
environmental law and regulations, protects the environment and public health, expends the least
amount of resources, is made quickly and causes the least amount of disruption. Decisions made
by ECWC must be based on valid scientific assumptions and good information, because those
decisions impact not only the environment but public health, the regulated community and
ECWC's credibility.
1.2 Quality Assurance Policy
Quality Assurance (QA) is an integrated system of management activities involving planning,
implementation, assessment, reporting, and quality improvement to ensure that a process, item,
or service is of the type and quality needed and expected by the customer. As a matter of
policy, ECWC is strongly committed to good science, and sound quality assurance practices.
It is a general objective that on all work performed by the ECWC Marine and Estuarine Division
that there be achievable data quality goals defined for every project in which Environmentally
Related Measurements will be generated. These goals will be stated in each QAPP.
1.3 QA Structure
The ECWC Marine and Estuarine Division utilizes a decentralized QA organization, relying on
each Branch and/or project within the division to be responsible for their own Quality Assurance
efforts, with overall QA Management and policy coming from Marine and Estuarine Division
QA Manager. Within the ECWC there is a QA Manager within each Division that is
responsible for preparation, maintenance, update and implementation of their respective
Division's QMP as described in the overall QMP for the ECWC. Figure 1-1 is an organization
chart that shows the lines of authority in the ECWC, and specifically in the Marine and
Estuarine Division.
1.4 Effective Date
This QMP becomes effective on the date finally approved by the U.S. EPA Region 6 QA
Officer, and remains in effect until revised at the time required by the U.S. EPA Marine and
Estuarine General Program Grant.
1.5 QMP/QAPP Policy
36
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Section No.. 1
Revision No
Page
This QMPs follows the guidance of Quality Assurance Management Staff (QAMS) at EPA"
^Headquarters (EPA QA/R-2). I3ie initial review and-approval of Quality Assurance Project
Plans, rests with the ECWC Marine and Estuarine Division QA Manager an Division Director.
Approval or disapproval and return of a QAPP to the submitter will be accomplished within 20
working days by the ECWC Marine and EstuarineEsturaine Division QA Manager. Once a
QAPP is deemed acceptable it will be forwarded to the QA Managers of any other ECWC
Division that has any participation in the project for concurrence. After all participating ECWC
Divisions have approved/concurred on the QAPP it will be forwarded on to the ECWC QA
Manager for final review/approval and forwarding to EPA Region 6. Specific written comments
shall be provided when a QAPP is disapproved that assist the submitter in creating a workable
QAPP. Final approval of QAPPs rests with the appropriate EPA Region 6 Division QA Officer.
Once a QAPP is approved, it is in effect until the project is completed. QAPPs must follow the
guidance of QAMS for QAPPs, which is EPA QAMS 005/80.
1.6 QA Plan Document Control Numbering
All QMPs and QAPPs will be assigned a document control number by the ECWC QA Manager,
prior to submission to EPA. Individual tasked with responsibility for preparation or revision of
a QA Plan will receive'and use that document control number in that respective QA Plan. QA
Plan format for ECWC defined by ECWC SOP # 5 (Appendix B) will be followed without
exception in the Marine and Estuarine Division.
1.7 QA Manager
The ECWC Marine and Estuarine Division Quality Assurance Manager and staff will be
responsible for the following QA activities (see Section 9 for explanation of these functions):
1.7.1 Preparation and submission of the Marine and Estuarine Division QMP;
1.7.2 Review and approval of all Marine and Estuarine Division QAPPs;
1.7.3 Laboratory audits (multimedia and program specific):
1.7.4 Certification of laboratories; and
1.7.5 Maintenance of a file system that contains a copy of all current Marine and Estuarine
Division QAPPs.
37
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Section No._
Revision No..
12. 1996
Page__3
FIGURE 1
ECWC MARINE D ESTUARBSE DIVISION PERSONNEL
38
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Section No._
Revision No.
Date Sept. 12. 1996
Page 4 of 17
2. QUALITY SYSTEM AND DESCRIPTION
The ECWGJ Marine and Estuarine Division utilizes a decentralized QA organization, relying on
each project to be responsible for their own Quality Assurance efforts, with overall QA
Management and policy coming from Marine and Estuarine Division QA Manager.
2.1 Project Quality Assurance Functions
Each Project Director shall be jointly responsible for the following QA activities in their
respective Projects, along with the Project QA Officer:
2.1.1 Concurrence and submission of QAPPs to Region 6 Office of Quality Assurance for
final approval;
2.1.2 Assignment of a QA/QC Technical Liaison between Project and Marine and Estuarine
Division;
2.1.3 Providing routine technical guidance to Project Staff on implementation of the
QAPPs;
2.1.4 Maintenance or oversight of a file system that contains a copy of all valid SOPs; and
2.1.5 Preparation of a quarterly QA report on each project that will be submitted to the Marine
and Estuarine Division QA Officer.
2.2 Data Quality Objective (DQO) Process
The Data Quality Objective (DQO) Process is an essential tool to be used in planning all
environmental data collection activities. DQOs shall be developed following all current and
applicable EPA guidance (Currently EPA QA/G-4, Guidance for Planning for Data Collection
in Support of Environmental Decision Making Using the Data Quality Objectives Process.
Participants in the DQO process shall be those individuals that represent organizations that are
involved or could be affected by the respective project. At a minimum the ECWC Marine and
Estuarine Division Project Director, Project Officer and Project QA Officer will participate.
A representative will be requested from the ECWC elements that will collect samples, analyze
samples. At least 30 days prior to initiation of DQO Planning session the Project Director shall
provide a list of proposed organizations/individuals that will be invited to participate. Region
6 EPA Project Officer will be kept apprised of DQO sessions, and invited to participate.
2.3 QA Project Plans (QAPPs)
Every project involving the collection of environmental data must have a written Quality
39
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Section No. 2
Revision No. 4
Date Sent. 12. 1996
Page__5_ of 17
Assurance Project Plan (QAPPs) approved prior to initiation of data collection activities:
A QAPP presents, in specific terms, the policies, organization, objectives, functional activities,
QA, and quality control (QC) activities designed to achieve the data quality objectives (DQOs)
of a particular project or continuing operation. The typical characteristics of a good QAPP are:
. requirements for management and technical audits and
a process for correction of deficiencies.
. a requirement for documenting sampling procedures
. the definition of specific QC activities.
EPA is responsible for policy on format and areas of coverage for QAPPs. Each QAPP will
cite the specific QMP, and its effective date, that it falls under. No QAPP can be approved
without an approved QMP, as the QMP is essential for defining the criteria of a QAPP.
Implementation of QAPPs will be evaluated by U.S. EPA Region 6 Office of QA through audits
and other means.
2.4 In-House Projects
The ECWC Marine and Estuarine Division will prepare QAPPs for all projects that will be
performed totally by ECWC personnel. All QAPPs will conform -to QAMS 005/80 or EPA
QA/R-5. The Project QA Officer shall evaluate the implementation of these plans.
2.5 Contracted Projects
The contractor will prepare QAPPs for all projects that will be performed totally by contractor
personnel. All QAPPs will conform to EPA QA/R-5. The Contractor's QA Officer shall
evaluate the implementation of these plans, and oversight of this evaluation shall be performed
annually by designated ECWC Marine and Estuarine Division Staff.
2.6 Standard Operating Procedures (SOPs)
Standard Operating Procedures (SOPs) may be developed and incorporated into QMPs or QAPPs
by reference and attachment. Use of SOPs is encouraged both as a method to reduce variation
and to reduce costs, when a similar method or process is utilized in a number of projects or
programs. All SOPs shall be written, reviewed, approved and updated in accordance with
ECWC SOP # 1, revision current at time SOP is approved.
40
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Section No. 2
Revision No. 4
.120926.
2.7 Management Systems Reviews (MSRs) Page_JL_ of 17
Management System Reviews shall be performed on all projects within 1?80 days"of project
completion. Staff designatedito perform MSRs:will he defined: in the respective QAPPs. MSR
reports will be prepared and submitted to respective Project Officer for review, comment and
if requested, corrective action(s) within 90 days ofi completion of the MSR by the MSR4eam
leader. If corrective action is requested the Project Officer shall define the necessary corrective
action(s) to be taken in a response to the MSR team leader.
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Section No._
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3. PERSONNEL QUALIFICATIONS AND TRAINING
3.1 Required certification
All ECWC sample collectors receive 32 hours of formal training an successfully complete a
written and performance examination prior to collection of any samples in accordance with
ECWC Samplers Certification Program, formally approved by U.S. EPA, Region 6 on July 11,
1993. After 90 days of OJT, a sample collector is fully certified if all observed work has been
of an acceptable quality to the first line supervisor. All ECWC Marine and Estuarine Division
Project Officers, Project and Division QA Officers, QA Coordinators, and Project Directors
shall be certified for QA in accordance with ECWC Directive # 5-92 (Appendix C).
3.2 Establishing training requirements for personnel
The Project QA Officer is making plans to attend the 1994 EPA National QA Meeting, and will
attend several training courses there.
At the present time, no specified training is required above and beyond what staff personnel are
already capable of; however, training will be sought which will improve the effectiveness of the
staff. Original FY 94 budget had allocated considerable funding for staff training, but had to
be re-allocated to cover salaries. Some money is available for training from other sources, but
it is anticipated that it will not be enough to cover all the training desirable for project personnel.
3.3 Identifying and satisfying technical and project management training needs;
Each Division of the ECWC participates in the centrally managed East Carolina Personnel
Commission's annual training survey, which defines training needs by department.
3.4 Identifying and/or designing training programs to meet these needs;
Where there are existing training programs personnel requiring such training can enroll and take
training at their discretion, with first line supervisor approval.
3.5 Performing introductory training and continuing training (or re-training);
U.S. EPA Region 6 will present the following courses:
1. Orientation to Quality Assurance Management,
2. Data Quality Objectives,
3. Quality Management Plans and Quality Assurance Project Plans Seminar.
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Section No.
Revision No.
Sept. 12.
3.6 Encouraging professional development beyond initial qualifications; Page§ of _17_
All ECWC staff are encouraged to take training to prepare themselves for acceptance of
/positions requiring higher level skills and abilities.
3.7 Documenting and maintaining training records for personnel;
The East Carolina Personnel Commission maintains all training records of East Carolina State
employees. Training records are forwarded to the East Carolina Personnel Commission at the
discretion of the employee, with concurrence of the first line supervisor.
3.8 Identifying qualified trainers;
All ECWC Marine and. Estuarine Division staff that conduct training shall have as a minimum:
- completed any course they conduct;
- completed a course in conducting training;
- a dry and sarcastic sense of humor;
- a latent disrespect for "sacred cows";
- complete support of University of Texas Longhorns athletics.
3.9 Assessing the effectiveness of training and (where applicable) establishing a program
for training and updating the instructors on training techniques and technical changes; and
Evaluations from each ECWC Marine and Estuarine Training course will be evaluated by the
course instructors for areas in which improvements can be made. Supervisors of instructors will
review all course evaluations also.
3.10 Reviewing and updating training materials and course content.
All training courses will be reviewed and updated annually, and more frequently if course
evaluations are consistently negative, or if significant changes to documents, regulations, policy
or state or federal laws that courses are based upon are changed.
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Section No._
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Page 9 of 17
4. PROCUREMENT OF ITEMS AND SERVICES
4.1 Processoror defining and;assuring that 1QA/QC requirements for all applicable acquisi-
tions are documented for each acquisition action;
All procured items will be field tested prior to actual data collection activities to ensure they are
performing properly. Project personnel will verbally inform project officer of non-conforming
equipment or supplies.
4.2 Process to assure changes to procurement documents receive the same review approvals
as the original documents;
Any changes to procurement documents will be approved by the Project Officer or designee.
4.3 Process to assure QA/QC requirements are adequately addressed hi responses to
applicable solicitations and that QA/QC is an integral criterion of the evaluation criteria;
Commonwealth of East CaroJina=General:Services Agency creates the policy for all procurement
activities, ECWC provides input into that process to assure QA/QC requirements are met
4.4 Process for ensuring that contracted and subcontracted activities produce results of
acceptable quality.
Each project QAPP will define the process by which supplies and services are accepted for the
ECWC from the supplier or contractor.
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Section No.
Revision No._
Page__lQ_
5. DOCUMENTATION and RECORDS
fel Documentation and* Procedure for Review of Quality Assurance Project Plans
The review will be conducted using EPA Requirements for Quality Assurance Project Plans for
Environmental Data Operations (EPA QA/R-5) as a standard along with this QMP. Approved,
Quality Assurance Project Plans will be maintained in the files of the appropriate Project Office
while the approved Quality Management Plan will be maintained by the Quality Assurance
Manager. Each QAPP shall cite the QMP that it falls under, including approval date.
5.3. Record Maintenance
All quality assurance documents of the ECWC Marine and Estuarine Division will be filed after
action in the central ECWC file room. The documents will be maintained under the supervision
of a file clerk. The file clerk will take special care to preserve the integrity of sensitive
documents such as enforcement actions. This special care includes such precautions as locking
these files in the absence of the file clerk. If sensitive documents are to be used at a work
station, due care will be used there, too, in order to maintain the integrity of the data.
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Section No..
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6. USE OF AUTOMATED DATA PROCESSING SYSTEM Page.
6.1. Policy
It is an ECWC policy that data collected, analyzed, processed and maintained on all automated
data processing (ADP) systems, in support of environmental studies, be accurate and of
sufficient integrity to support effective environmental management.
In order to ensure the effective and efficient use of the ECWC's ADP systems, including
hardware and software system design, development, implementation, and maintenance, ECWC
will follow the Commonwealth of East Carolina's Information Resource Management (IRM)
Policy.
6.2 Computer Hardware and Software Requirements
6.2.1 All hardware and software shall meet Commonwealth of East Carolina's
Informational Resource Management Hardware and Software Standards from the
Architectural Management and Planning Branch of the ECIRM's Data Processing
Division.
6.2.2 All software systems shall be developed and designed according to the
ECIRM's Systems and Development Guidance.
6.2.3 All software systems shall be operated and maintained according to ECIRM's
Operation and Maintenance Manual.
6.2.4 For integrity of computer resident data in stand alone PC systems, the
laboratories or offices which use systems for environmental effects studies shall
follow the EPA Good Automated Laboratory Practices guidelines.
6.4 Data Management
To take full advantage of the ECWC's growing technological and data resources, there needs
to be an increased emphasis on improving compatibility of data among the systems. For
consistent definition of data, and to facilitate cross-media use of data, all data produced or
collected by the computers shall be managed as specified in the Commonwealth of East
Carolina's IRM Policy Manual. ECIRM is in the process of developing State-wide data
standards, in the ECIRM Catalog of Data Policies and Standards. This catalog will summarize
State data policies and standards which are the definitive list of data standards that East Carolina
agency personnel and contractors must meet when developing information systems.
6.5 Information Security
It is important that the ECWC's information resources are protected from potential loss and
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Section No.
Revision No.
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Page 12 of 17
misuse from a variety of accidental-and deliberate causes, which can take the form of
destruction, disclosure, alteration, delay or undesired manipulation.
For a comprehensive, Statewide security program to safeguard the ECWC's information
resources, all information resources shall be safeguarded as specified in the ECIRM ADP
Disaster .Recovery Plan.
6.6 Documents
For proper implementation and maintenance of the system, the appropriate offices shall have:
6.6.1 A written description of the computer system(s) hardware and a written operating
procedures for routine maintenance operations;
6.6.2 A written document which contains detailed description of'the software in use,
including the listing of all algorithms or formulas used for data generation, processing
and assessment, clear guidelines for data acceptance criteria, criteria for data
validation/invalidation, data deletion/addition, and data correction; and
6.6.3 Standard Operating Procedures (SOPs) which describe the routine operation,
maintenance and testing, to ensure that both the hardware and software in use is
accurately performing the intended functions.
These documents shall be readily available in the areas where these procedures will be
performed. Published literature or vendor documentation may be used as a supplement to
software documentation if properly referenced therein. All deviations from the operational
instructions for data collection systems shall be authorized by the designated responsible person.
Changes in any part of the operating procedures shall be properly authorized, reviewed and
accepted in writing by the designated responsible person.
6.7 Personnel
Personnel involved in computer data collection systems, hardware and software shall:
6.7.1 have adequate education, training, and experience to perform the assigned system
functions;
6.7.2 have a current summary of their training, experience, and job description,
including information relevant to system design and operation maintained at the facility;
and
6.7.3 be of sufficient number for timely and proper conduct of the study, including
timely and proper operation of the automated data collection system(s).
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Section No. 7__
Revision No. 4
Patent, 12, 1996
Page
7. PLANNING
7.1 Customer Identification Process
The customer for the results of the work is the Environmental Conditions of the Bays and
Estuaries of the Commonwealth of East Carolina.
7.2 Identification of Customer Needs and Expectations
The ECWC will use the Data Quality Objectives Process (DQO) planning methodology for all
in-house projects that will exceed $ 75,000 per year. For projects to be performed by a
Contractor Data Quality Objectives will be used at the discretion of the Contractor.
7.3 Creation of Quality Specifications for Data
The ECWC Marine and Estuarine Division utilizes the DQO process to define the data quality
specifications for each project. Once the DQO process is accomplished for a project not only
does it define data quality requirements, but it also considers any cost and schedule constraints
within which project activities are required to be performed, and identifies acceptance criteria
for the result or measures of performance by which customer satisfaction will be determined.
48
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Section No.. 8
Revision No.___4
Page 14 Of _17_
8. IMPLEMENTATION OF WORK PROCESSES
8.1 Procedures for ensuring that work is performed according to plan
All ECWC Marine and Estuarine Division environmental data operations project will be imple-
mented in accordance with the Quality Assurance Project Plan. The ECWC Marine and
Estuarine Division Director meets quarterly with all Project Managers to review implementation
status of projects.
8.2 Level of management oversight and inspection
The level of oversight and inspection will be commensurate with the importance of particular
projects and the intended use of the data.
8.3 Procedures for appropriate routine, standardized, special, or critical operations
development and implementation
8.3.1 Identification of operations needing procedures
Operations requiring procedures are defined in the QAPP. If the procedures are standard
or routine they will be covered in depth in the ECWC Sampling Handbook, which will
be incorporated by reference into all QAPPs.! ECWG SOPs, can be used in the same
manner where applicable.
8.3.2 Preparation of procedures
All special and critical operations procedures will be defined in the applicable QAPP in
detail.
8.3.3 Review and approval of procedures
All procedures will be approved by the Director ECWC Marine and Estuarine Division
prior to actual use. Special and critical operations procedures will be peer reviewed by
at least three Project Officers prior to submission for final approval.
49
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Section No.
Revision No.
Date Sent. 12.
Page 15 of 17
9. QUALITY ASSESSMENT AND RESPONSE
Even the best QA plans are of limited value unless they are implemented. In order to ensure
that QA plans are being implemented and that they are adequate, a series of technical and
managerial audits are necessary. These audits comprise the major mechanism of the ECWC
oversight. The QAPP must describe how and by whom assessments of environmental programs
are planned, conducted, and evaluated to measure the effectiveness of the implemented quality
system. The assessment tools for environmental programs encompass:
management systems reviews,
surveillances,
audits,
performance evaluations,
audits of data quality,
peer reviews and technical reviews,
readiness reviews, and
data quality assessments.
9.1 Planning, scheduling, and implementation of assessment and response to needed
changes
Project Officers have total responsibility for assessments-of their projects.
9.2 Definition of responsibilities, levels of participation, and authority for staff
Coverage of these items is in section 9.4.
9.3 How, when, and by whom actions will be taken in response to the findings of the
assessment, and how the effectiveness of the response will be determined.
Responses to assessment findings will be the responsibility of the Project QA Officer.
9.4 Ability of personnel conducting assessments 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;
independently confirm implementation and effectiveness of solutions; and
provide documented assurance to line management that, when problems are
identified, further work performed is monitored carefully until the problems are
suitably resolved.
50
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Section No
Revision No
The personnel performing in-house management assessments are trained managers with years
of supervisory, managerial and administrative experience. The technical self-assessments will
be .performed by Project Managers and Project Officers who are intimately familiar with the
goals of the project. .The independent technical assessment will be performed by natural
resource specialist with years of experience in their respective fields. As the assessors are fully
qualified professionals in their fields, any recommendations made will be considered by the
Project Managers and Project Officer of the particular project under assessment, and
implemented immediately, with approval of the Director.
External assessments will be performed by U.S. EPA QAMS Staff. Recommendations made
by QAMS will be considered by the Project Managers and Project Officer of the particular
project under assessment, and implemented immediately, with approval of the Director.
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Section No. 10
Revision No. 4 _
12. 1996
Page
10. QUALITY IMPROVEMENT
This section of the QMP includes a description ofrthe ECWC Marine and Estuarine Division's
management system for. detecting and preventing quality problems and for ensuring continuing
quality improvement.
10.1 Process and personnel responsible for identifying, planning, implementing, and
evaluating the effectiveness of quality improvement activities.
In the ECWC Marine and Estuarine Division the Quality Manager has total responsibility for
Quality Improvement. On each project the Project QA Officer has total responsibility for
Quality Improvement.
10.2 Corrective action program.
Each QAPP will define a method to ensure that conditions adverse to quality are identified
promptly and corrected as soon as practical. This Corrective Actions process shall include the
identification of root causes of problems, determining if the problem is unique or has more
generic implications, and recommending procedures to prevent recurrence.
52
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APPENDIX A
TERMS AND DEFINITIONS
Terms and definitions are at the back of this book at page 247.
53
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NOTES
54
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QMP CLASSROOM EXERCISE #2
In our same small groups, we will now revise the "Bad Example" of a Quality Management
Plan into a "Better Example" of a QMP.
Work in your group on the sections assigned by the instructor, using EPA QA/R-2 as the criteria
document for the revision.
55
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NOTES
56
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QUALITY MANAGEMENT PLAN
FOR
MARINE AND ESTUARINE ENVIRONMENTAL
MONITORING AND REMEDIAL ACTION
SUBMITTED BY EAST CAROLINA
WATER COMMISSION
57
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Original Table of Contents:
TABLE OF CONTENTS
SECTION NO.
HEADING
REVISION
PAGEl
N/A
N/A
N/A
1.0
2.0
3.0
4.0
5.0
6.0
7.0
8.0
9.0
10.0
App A
Title Page
Table of Contents
Quality Management Plan
Approval Page
Quality Management and
Organization
Quality System and Description
Personnel Qualifications
and Training
Procurement of Items and
Services
Quality Documentation and
Records
Use of Automated Data
Processing System
Quality Planning
Quality Implementation of
Work Processes
Quality Assessment and Response
Quality Improvement
Appendices
Appendix A-Definitions
4
4
4
4
4
4
4
4
4
4
4
4
4
N/A
i
ii
1
3
5
6
7
8
10
11
12
14
A-l
Comments:
Table of Contents is not a required item for a QMP, but it certainly adds to the usefulness,
especially in longer QMPs.
58
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Original Approval Page:
Quality Management Plan for work to be performed by, or implemented by, the East Carolina
Water Commission, for all efforts involving Marine and Estuarine Environmental Monitoring
and Remedial Action, in the State and Coastal Waters of the Commonwealth of EasLCarolina.
East Carolina Water Commission Document Control Number OMP-1996-ME Div.-l
EPA Region 6 QTRAK #
Plan Prepared By:
Date:
Susan Daigle, , ECWC Marine & Estuarine
Division Quality Assurance Manager
ECWC Concurrence:
Date:
Joan Breedon, Laboratory Director
Date:
Bob Gilmore, Data Processing Chief
Date:
Paul Cronin, Field Operations Chief
ECWC Approvals:
Date:
Darryl Royale, Marine and Estuarine
Division Director
Date:
Shelia Meyers, Quality Manager ECWC
Date:
Barry Switchitter, ECWC Commissioner
EPA Approvals:
Date:
Alva L. Smith, Chief, 6E-Q
Quality Assurance Officer
59
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REMEMBER- 3 COPIES ARE RECOMMENDED TO BE SUBMITTED, ALL WITH
ORIGINAL SIGNATURES.
Requirement; (From Section 1 of EPA QA/R-2)
This section of the QMP shall contain or address the following management and organizational
items:
an approval page for the signatures of the accountable managers, senior line
management (as appropriate), and the QA Manager/QA Officer of the organiza-
tion, and for the Region 6 QA Officer, and appropriate Region 6 Program Office
staff. This approval page may be part of a title page or a separate sheet follow-
ing the tide page.
TASK 1. GROUP ASSIGNMENT:
Revise the original organizational chart, adding or deleting at the consensus of the work
group.
60
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Original Section 1:
1. QUALITY MANAGEMENT AND ORGANIZATION
1.1 ECWC Marine and Estuarine Division Mission
The mission of ECWC Marine and Estuarine Division is to monitor and protect the environment
to the extent outlined by Commonwealth of East Carolina Statutory Law and the delegated
responsibilities from the U.S. Code of Federal Regulations that U.S. EPA has empowered the
ECWC. A good decision for ECWC is one that follows both the spirit and letter- of
environmental law and regulations, protects the environment and public health, expends the least
amount of resources, is made quickly and causes the least amount of disruption. Decisions made
by ECWC must be based on valid scientific assumptions and good information, because those
decisions impact not only the environment but public health, the regulated community and
ECWC's credibility.
1.2 Quality Assurance Policy
Quality Assurance (QA) is an integrated system of management activities involving planning,
implementation, assessment, reporting , and quality improvement to ensure that a process, item,
or service is of the type and quality needed and expected by the customer. As a matter of
policy, ECWC is strongly committed to good science, and sound quality assurance practices.
It is a general objective that on all work performed by the ECWC Marine and Estuarine Division
that there be achievable data quality goals defined for every project in which Environmentally
Related Measurements will be generated. These goals will be stated in each QAPP.
1.3 QA Structure
The ECWC Marine and Estuarine Division utilizes a decentralized QA organization, relying on
each Branch and/or project within the division to be responsible for their own Quality Assurance
efforts, with overall QA Management and policy coming from Marine and Estuarine Division
QA Manager. Within the ECWC there is a QA Manager within each Division that is
responsible for preparation, maintenance, update and implementation of their respective
Division's QMP as described in the overall QMP for the ECWC. Figure 1-1 is an organization
chart that shows the lines of authority in the ECWC, and specifically in the Marine and
Estuarine Division.
1.4 Effective Date
This QMP becomes effective on the date finally approved by the U.S. EPA Region 6 QA
Officer, and remains in effect until revised at the time required by the U.S. EPA Marine and
Estuarine General Program Grant.
1.5 QMP/QAPP Policy
This QMPs follows the guidance of Quality Assurance Management Staff (QAMS) at EPA
61
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Headquarters (EPA QA/R-2). The initial review and approval of Quality Assurance Project
Plans, rests with the ECWC Marine and Estuarine Division QA Manager an Division Director.
Approval or disapproval and return of a QAPP to the submitter will be accomplished within 20
working days by the ECWC Marine and Esturaine Division QA Manager. Once a QAPP is
deemed acceptable it will^be forwarded to the QA Managers of any other ECWC Division, that
has any participation in the project for concurrence. After all participating ECWC Divisions
have approved/concurred on the QAPP it will be forwarded on to the ECWC QA Manager for
final review/approval and forwarding to EPA Region 6. Specific written comments shall be
provided when a QAPP is disapproved that assist the submitter in creating a workable QAPP.
Final approval of QAPPs rests with the appropriate EPA Region 6 Division QA Officer. Once
a QAPP is approved, it is in effect until the project is completed. QAPPs must follow the
guidance of QAMS for QAPPs, which is EPA QAMS 005/80.
1.6 QA Plan Document Control Numbering
All QMPs and QAPPs will be assigned a document control number by the ECWC QA Manager,
prior to submission to EPA. Individual tasked with responsibility for preparation or revision of
a QA Plan will receive and use that document control number in that respective QA Plan. QA
Plan format for ECWC defined by ECWC SOP # 5 (Appendix B) will be followed without
exception in the Marine and Estuarine Division.
1.7 QA Manager
The ECWC Marine and Estuarine Division Quality Assurance Manager and staff will be
responsible for the following QA activities (see Section 9 for explanation of these functions):
1.7.1 Preparation and submission of the Marine and Estuarine Division QMP;
1.7.2 Review and approval of all Marine and Estuarine Division QAPPs;
1.7.3 Laboratory audits (multimedia and program specific):
1.7.4 Certification of laboratories; and
1.7.5 Maintenance of a file system that contains a copy of all current Marine and Estuarine
Division QAPPs.
Requirement; This section of the QMP shall contain or address the following management and
organizational items:
a statement of the organization's policy on quality assurance, including:
the level of importance of QA/QC to the organization and why,
the general objectives/goals for QA/QC, and
the commitment of resources for QA/QC;
62
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an organization chart that identifies all of the components of the organization and,
in particular, the organizational position of the QA Manager/QA Officer;
a discussion of the responsibilities and authorities of the QA Manager/QA Officer
and any other QA staff, including:
the line of reporting to senior management, and
the means by which management will be kept informed about quality
issues;
a discussion of the mission of each organization component, functional responsi-
bilities of management and staff, levels of accountability and authority, and lines
of communication for planning, implementing, and assessing environmental
programs;
a discussion of the QA/QC roles and responsibilities of line management,
technical staff, and any other staff;
identification of all activities to which QA/QC are to be applied;
how management will assure that applicable elements of the Quality System are
understood and are implemented in all activities under their responsibility
involving environmental programs;
TASK 1. INDIVIDUAL ASSIGNMENT:
Using material from the next two pages and the instructor, develop a revised
organizational chart for the ECWC Marine and Estuarine Division.
63
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NOTES
64
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PROJECT DIRECTOR
Cedar Bay Project
Zack Dempsey
(777) 555-1210
QA OFFICER
Cedar Bay Project
Troy Achemann
(777) 555-1212
C/ECWC Mgmt. Info.
Systems Branch
Bob Gilmore
(777) 555-1214
QC/LAB
Robert Mendez
(777) 555-1216
QC/FIELD
Diane Jenkins
(777) 555-1218
PROJECT OFFICER
Cedar Bay Project
Rebecca Quince
(777) 555-1211
COMMISSIONER
ECWC
Barry SwiteMtter
(777) 555-1200
LABORATORY MANAGER
ECWC Central Lab.
Joan Breedon
(777) 555-1213
DIRECTOR
Marine & Division
Darryle Royale
(777) 555-1205
C/ECWC Field
Operations Branch
Paul Cronin
(777) 555-1215
QC/ADP
Mark Preston
(777) 555-1217
ECWC QUALITY MANAGER
Sheila Meyers
(777) 555-1204
QUALITY MANAGER
Marine & Division
Susan Daigle
(777) 555-1222
65
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NOTES
66
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FIGURE 1
ECWC Marine and Estuarine DIVISION PERSONNEL
67
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NOTES
68
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TASK 2. GROUP ASSIGNMENT:
Each group will reach a consensus on the Organizational Chart that will be the
most effective for this organization. Revise chart as required, to reach consensus.
PROJECT DIRECTOR
Cedar Bay Project
Zack Dempsey
(777) 555-1210
QA OFFICER
Cedar Bay Project
Troy Achemann
(777) 555-1212
C/ECWC Mgmt. Info.
Systems Branch
Bob Gilmore
(777) 555-1214
QC/LAB
Robert Mendez
(777) 555-1216
QC/FIELD
Diane Jenkins
(777) 555-1218
PROJECT OFFICER
Cedar Bay Project
Rebecca Quince
(777) 555-1211
COMMISSIONER
ECWC
Barry Switchitter
(777) 555-1200
LABORATORY MANAGER
ECWC Central Lab.
Joan Breedon
(777) 555-1213
DIRECTOR
Marine & Division
Darryle Royale
(777) 555-1205
C/ECWC Field
Operations Branch
Paul Cronin
(777) 555-1215
QC/ADP
Mark Preston
(777) 555-1217
ECWC QUALITY MANAGER
Sheila Meyers
(777) 555-1204
QUALITY MANAGER
Marine & Division
Susan Daigle
(777) 555-1222
69
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NOTES
70
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FIGURE 1
ECWC Marine and Estuarine DIVISION PERSONNEL
71
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NOTES
72
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TASK 3. GROUP ASSIGNMENT:
Once the organizational chart is complete, as a group, revise the areas of. Section 1. that
are not effective in the space below. Section must comply with requirements above.
73
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Original Section 2;
2. QUALITY SYSTEM AND DESCRIPTION
The ECWC Marine and Estuarine Division utilizes a decentralized QA organization, relying
on each project to be responsible for their own Quality Assurance efforts, with overall QA
Management and policy coming from Marine and Estuarine Division QA Manager.
2.1 Project Quality Assurance Functions
Each Project Director shall be jointly responsible for the following QA activities in their
respective Projects, along with the Project QA Officer:
2.1.1 Concurrence and submission of QAPPs to Region 6 Office of Quality Assurance for
final approval;
2.1.2 Assignment of a QA/QC Technical Liaison between Project and Marine and Estuarine
Division;
2.1.3 Providing routine technical guidance to Project Staff on implementation of the
QAPPs;
2.1.4 Maintenance or oversight of a file system that contains a copy of all valid SOPs; and
2.1.5 Preparation of a quarterly QA report on each project that will be submitted to the
Marine and Estuarine Division QA Officer.
2.2 Data Quality Objective (DQO) Process
The Data Quality Objective (DQO) Process is an essential tool to be used in planning all
environmental data collection activities. DQOs shall be developed following all current and
applicable EPA guidance (Currently EPA QA/G-4, Guidance for Planning for Data
Collection in Support of Environmental Decision Making Using the Data Quality Objectives
Process. Participants in the DQO process shall be those individuals that represent
organizations that are involved or could be affected by the respective project. At a minimum
the ECWC Marine and Estuarine Division Project Director, Project Officer and Project QA
Officer will participate. A representative will be requested from the ECWC elements that
will collect samples, analyze samples. At least 30 days prior to initiation of DQO Planning
session the Project Director shall provide a list of proposed organizations/individuals that will
be invited to participate. Region 6 EPA Project Officer will be kept apprised of DQO
sessions, and invited to participate.
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2.3 QA Project Plans (QAPPs)
Every project involving the collection of environmental data must have a written Quality
Assurance Project Plan (QAPPs) approved prior to initiation of data collection activities.
A QAPP presents, in specific terms, the policies, organization, objectives, .functional
activities, QA, and quality control (QC) activities designed to achieve the data quality
objectives (DQOs) of a particular project or continuing operation. The typical, characteristics
of a good QAPP are:
. requirements for management and technical audits and
a process for correction of deficiencies.
. a requirement for documenting sampling procedures
. the definition of specific QC activities.
EPA is responsible for policy on format and areas of coverage for QAPPs. Each QAPP
will cite the specific QMP, and its effective date, that it falls under. No QAPP can be
approved without an approved QMP, as the QMP is essential for defining the criteria of a
QAPP.
Implementation of QAPPs will be evaluated by U.S. EPA Region 6 Office of QA through
audits and other means.
2.4 In-House Projects
The ECWC Marine and Estuarine Division will prepare QAPPs for all projects that will be
performed totally by ECWC personnel. All QAPPs will conform to QAMS 005/80 or EPA
QA/R-5. The Project QA Officer shall evaluate the implementation of these plans.
2.5 Contracted Projects
The contractor will prepare QAPPs for all projects that will be performed totally by
contractor personnel. All QAPPs will conform to EPA QA/R-5. The Contractor's QA
Officer shall evaluate the implementation of these plans, and oversight of this evaluation shall
be performed annually by designated ECWC Marine and Estuarine Division Staff.
2.6 Standard Operating Procedures (SOPs)
Standard Operating Procedures (SOPs) may be developed and incorporated into QMPs or
QAPPs by reference and attachment. Use of SOPs is encouraged both as a method to reduce
variation and to reduce costs, when a similar method or process is utilized in a number of
projects or programs. All SOPs shall be written, reviewed, approved and updated in
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accordance with ECWC SOP # 1, revision current at time SOP is approved.
2.7 Management Systems Reviews (MSRs)
Management System Reviews shall be performed on all projects within, 180 days of project
completion. Staff designated^ perform MSRs will be defined in the respective QAPPs.
MSR reports will be prepared and submitted to respective Project Officer for review,
comment and if requested, corrective action(s) within 90 days of completion of the MSR by
the MSR team leader. If corrective action is requested the Project Officer shall define the
necessary corrective action(s) to be taken in a response to the MSR team leader.
Requirement; This section of the QMP shall contain or address the following items
pertaining to the Quality System and the technical mission to which it applies:
A discussion of the principal components or "tools" comprising the organiza-
tion's Quality System and the process and procedures for their use. These
components include, but are not limited to:
Quality Management Plans
Management Systems Reviews
Data Quality Objectives Process
QA Project Plans
Standard Operating Procedures
Technical Assessments (Self and Independent)
Data Quality Assessments
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The process discussion should include the roles and responsibilities for all
management and staff in planning and implementing the Quality System.
A discussion of the technical activities or programs that are supported by the
Quality "System and to which the QA/QC controls, apply* that is^ the, specific;
programs that require extensive QA/QC controls; where oversight of delegat-
ed, contracted, or other extramural programs is needed to assure data quality;
and, where internal coordination of QA/QC among the group's organizational
units need to occur.
TASK 1. GROUP ASSIGNMENT:
Revise the areas of Section 2 that are not effective hi the space below. Section must
comply with requirements above.
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Original Section 3;
3. PERSONNEL QUALIFICATIONS AND TRAINING
3.1 Required certification
All ECWC sample collectors receive 32 hours of formal training an successfully complete a
written and performance examination prior to collection of any samples in accordance with
ECWC Samplers Certification Program, formally approved by U.S. EPA, Region 6 on July
11, 1993. After 90 days of OJT, a sample collector is fully certified if all observed work
has been of an acceptable quality to the first line supervisor. All ECWC Marine and
Estuarine Division Project Officers, Project and Division QA Officers, QA Coordinators, and
Project Directors shall be certified for QA in accordance with ECWC Directive # 5-92
(Appendix C).
3.2 Establishing training requirements for personnel
The Project QA Officer is making plans to attend the 1994 EPA National QA Meeting, and
will attend several training courses there.
At the present time, no specified training is required above and beyond what staff personnel
are already capable of; however, training will be sought which will improve the effectiveness
of the staff. Original FY 94 budget had allocated considerable funding for staff training, but
had to be re-allocated to cover salaries. Some money is.available for training from other
sources, but it is anticipated that it will not be enough to cover all the training desirable for
project personnel.
3.3 Identifying and satisfying technical and project management training needs;
Each Division of the ECWC participates in the centrally managed East Carolina Personnel
Commission's annual training survey, which defines training needs by department.
3.4 Identifying and/or designing training programs to meet these needs;
Where there are existing training programs personnel requiring such training can enroll and
take training at their discretion, with first line supervisor approval.
3.5 Performing introductory training and continuing training (or re-training);
U.S. EPA Region 6 will present the following courses:
1. Orientation to Quality Assurance Management,
2. Data Quality Objectives,
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3. Quality Management Plans and Quality Assurance Project Plans Seminar.
3.6 Encouraging professional development beyond initial qualifications;
All ECWC staff-are encouraged to-take training to prepare themselves for acceptance of
positions requiring higher level skills and abilities.
3.7 Documenting and maintaining training records for personnel;
The East Carolina Personnel Commission maintains all training records of East Carolina
State employees. Training records are forwarded to the East Carolina Personnel Commission
at the discretion of the employee, with concurrence of the first line supervisor.
3.8 Identifying qualified trainers;
All ECWC Marine and Estuarine Division staff that conduct training shall have as a
minimum:
- completed any course they conduct;
- completed a course in conducting training;
- a dry and sarcastic sense of humor;
- a latent disrespect for "sacred cows";
- complete support of University of Texas Longhorns athletics.
3.9 Assessing the effectiveness of training and (where applicable) establishing a program
for training and updating the. instructors on,training techniques and technical changes;
and
Evaluations from each ECWC Marine and Estuarine Training course will be evaluated by the
course instructors for areas in which improvements can be made. Supervisors of instructors
will review all course evaluations also.
3.10 Reviewing and updating training materials and course content.
All training courses will be reviewed and updated annually, and more frequently if course
evaluations are consistently negative, or if significant changes to documents, regulations,
policy or state or federal laws that courses are based upon are changed.
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Requirement; The QMP must reflect management's commitment to and describe its systems
for:
identifying certifications required to perform operations for the different
programs: for which the organization is responsible;,
establishing training requirements for personnel;
identifying and satisfying technical and project management training needs;
identifying and/or designing training programs to meet these needs;
performing introductory training and continuing training (or re-training);
encouraging professional development beyond initial qualifications;
documenting and maintaining training records for personnel;
identifying qualified trainers;
assessing the effectiveness of training and (where applicable) establishing a
program for training and updating the instructors on training techniques and
technical changes; and
reviewing and updating training materials and course content.
Included in the above is the responsibility of management to identify what qualifications or
certifications are necessary for, personnel,to perform their work safely and effectively,
TASK1. GROUP ASSIGNMENT:
Revise the areas of Section 3 so that this QMP reflects your group's personal feelings
regarding Training and Certification Requirements. Again, section must comply with
requirements above.
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TASK 1. GROUP ASSIGNMENT: (CONTINUED)
Revise the areas of Section 3 so that this QMP reflects your group's personal feelings
regarding Training and Certification Requirements. Again, section must comply with
requirements above.
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Original Section 4;
4. PROCUREMENT OF ITEMS AND SERVICES
4.1 Process for defining and assuring that QA/QC requirements for all applicable
acquisitions are documented for each acquisition action;
All procured items will be field tested prior to actual data collection activities to ensure they
are performing properly. Project personnel will verbally inform project officer of non-
conforming equipment or supplies.
4.2 Process to assure changes to procurement documents receive the same review
approvals as the original documents;
Any changes to procurement documents will be approved by the Project Officer or designee.
4.3 Process to assure QA/QC requirements are adequately addressed in responses to
applicable solicitations and that QA/QC is an integral criterion of the evaluation
criteria;
Commonwealth of East Carolina General Services Agency creates the policy for all
procurement activities, ECWC provides input into that process to assure QA/QC
requirements are met.
4.4 Process for ensuring that contracted and subcontracted activities produce results of
acceptable quality.
Each project QAPP will define the process by which supplies and services are accepted for
the ECWC from the supplier or contractor.
Requirement; This section of the QMP shall contain discussions of or address the following
issues pertaining to the procurement of items and services:
the organization's process for assuring that QA/QC requirements are defined
for all applicable acquisitions and that this assurance process is documented for
each acquisition action;
how changes to procurement documents will receive the same review approv-
als as the original documents;
the organization's process for assuring that QA/QC requirements are adequate-
ly addressed in all responses to applicable solicitations and that QA/QC is an
integral criterion of the evaluation criteria; and
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the organization's process for ensuring that contracted and subcontracted
activities 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, supplier audits^, and
examination of deliverables.
TASK 1. GROUP ASSIGNMENT:
Revise the areas of Section 4 so that this QMP reflects your group's personal feelings
regarding the "Best Way" to procure goods and services. Again, section must
comply with requirements above.
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Original Section 5;
5. DOCUMENTATION and RECORDS
5.1 Documentation and Procedure for Review of Quality Assurance Project Plans
The review will be conducted using EPA Requirements for Quality Assurance Project Plans
for Environmental Data Operations (EPA QA/R-5) as a standard along with this QMP.
Approved Quality Assurance Project Plans will be maintained in the files of the appropriate
Project Office while the approved Quality Management Plan will be maintained by the
Quality Assurance Manager. Each QAPP shall cite the QMP that it falls under, including
approval date.
5.3. Record Maintenance
All quality assurance documents of the ECWC Marine and Estuarine Division will be filed
after action in the central ECWC file room. The documents will be maintained under the
supervision of a file clerk. The file clerk will take special care to preserve the integrity of
sensitive documents such as enforcement actions. This special care includes such precautions
as locking these files in the absence of the file clerk. If sensitive documents are to be used
at a work station, due care will be used there, too, in order to maintain the integrity of the
data.
Requirement: This section of the QMP must include:
a description of the organization's process for identifying quality-related
documents and records requiring control;
a description of the organization's process 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;
a description of the process by which all technical guidance documents are
prepared, reviewed, approved, issued, used, and revised; and
a description of the process that ensures compliance with all statutory, contrac-
tual, 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.
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TASK 1. GROUP ASSIGNMENT:
Revise the areas of Section 5 so that this QMP reflects your group's personal feelings
regarding the "Best Way" to do documentation and recording of QA information.
Again, section must comply witb requirements above.
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Original Section 6;
6. USE OF AUTOMATED DATA PROCESSING SYSTEM
6.1. Policy
It is an ECWC policy that data collected, analyzed, processed and maintained on all
automated data processing (ADP) systems, in support of environmental studies, be accurate
and of sufficient integrity to support effective environmental management.
In order to ensure the effective and efficient use of the ECWC's ADP systems, including
hardware and software system design, development, implementation, and maintenance,
ECWC will follow the Commonwealth of East Carolina's Information Resource Management
(IRM) Policy.
6.2 Computer Hardware and Software Requirements
6.2.1 All hardware and software shall meet Commonwealth of East Carolina's
Informational Resource Management Hardware and Software Standards from the
Architectural Management and Planning Branch of the ECIRM's Data Processing
Division.
6.2.2 All software systems shall be developed and designed according to the
ECIRM's Systems and Development Guidance.
6.2.3 All software systems shall be operated and maintained according to ECIRM's
Operation and Maintenance Manual.
6.2.4 For integrity of computer resident data in stand alone PC systems, the
laboratories or offices which use systems for environmental effects studies shall
follow the EPA Good Automated Laboratory Practices guidelines.
6.4 Data Management
To take full advantage of the ECWC's growing technological and data resources, there needs
to be an increased emphasis on improving compatibility of data among the systems. For
consistent definition of data, and to facilitate cross-media use of data, all data produced or
collected by the computers shall be managed as specified in the Commonwealth of East
Carolina's IRM Policy Manual. ECIRM is in the process of developing State-wide data
standards, in the ECIRM Catalog of Data Policies and Standards. This catalog will summarize
State data policies and standards which are the definitive list of data standards that East Carolina
agency personnel and contractors must meet when developing information systems.
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6.5 Information Security
It is important that the ECWC's information resources are protected from potential loss and
misuse from a variety of accidental and deliberate causes, which can take the form of
destruction, disclosure, alteration, delay or undesired manipulation.
For a comprehensive, Statewide security program to safeguard the ECWC's information
resources, all information resources shall be safeguarded as specified in the ECIRM ADP
Disaster Recovery Plan.
6.6 Documents
For proper implementation and maintenance of the system, the appropriate offices shall have:
6.6.1 A written description of the computer system(s) hardware and a written operating
procedures for routine maintenance operations;
6.6.2 A written document which contains detailed description of the software in use,
including the listing of all algorithms or formulas used for data generation, processing
and assessment, clear guidelines for data acceptance criteria, criteria for data
validation/invalidation, data deletion/addition, and data correction; and
6.6.3 Standard Operating Procedures (SOPs) which describe the routine operation,
maintenance and testing, , to .ensure that-both the, hardware .and. software in use is
accurately performing the intended functions.
These documents shall be readily available in the areas where these procedures will be
performed. Published literature or vendor documentation may be used as a supplement to
software documentation if properly referenced therein. All deviations from the operational
instructions for data collection systems shall be authorized by the designated responsible person.
Changes in any part of the operating procedures shall be properly authorized, reviewed and
accepted in writing by the designated responsible person.
6.7 Personnel
Personnel involved in computer data collection systems, hardware and software shall:
6.7.1 have adequate education, training, and experience to perform the assigned system
functions;
6.7.2 have a current summary of their training, experience, and job description,
including information relevant to system design and operation maintained at the facility;
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and
6.7.3 be of sufficient number for timely and.proper conduct of me study, including
timely and proper operation of the automated .data collection system(s).
Requirement: This section of the QMP shall address the use of computer hardware and
software in the organization's operations. Specifically, the QMP must:
describe the process for ensuring that computer hardware used in environmental
programs meets the requirements of these programs;
describe how changes to hardware shall be controlled to assess the impact of the
change on performance;
describe 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;
describe how purchased software is evaluated to meet user requirements and to
comply with applicable organizational policy regarding software proliferation and
configuration management standards; and
describe the process for ensuring that data and information produced from or
collected by computers meet applicable organizational policy standards.
These descriptions shall include the roles and responsibilities assigned to management and staff.
TASK1. GROUP ASSIGNMENT:
As a group, using the requirements from above, and the supporting rationale, revise
this QMP Section.
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Original Section 7:
7. PLANNING
7.1 Customer Identification Process
The customer for the results of the work is the Environmental Conditions of the Bays and
Estuaries of the Commonwealth of East Carolina.
7.2 Identification of Customer Needs and Expectations
The ECWC will use the Data Quality Objectives Process (DQO) planning methodology for all
in-house projects that will exceed $ 75,000 per year. For projects to be performed by a
Contractor Data Quality Objectives will be used at the discretion of the Contractor.
7.3 Creation of Quality Specifications for Data
The ECWC Marine and Estuarine Division utilizes the DQO process to define the data quality
specifications for each project. Once the DQO process is accomplished for a project not only
does it define data quality requirements, but it also considers any cost and schedule constraints
within which project activities are required to be performed, and identifies acceptance criteria
for the result or measures of performance by which customer satisfaction will be determined.
Requirement; This section of the QMP shall document how and by whom work shall be
planned by the organization. Minimally, the QMP shall describe the system or process used to:
identify the customer for whom the work is to be performed,
identify the needs and expectations of the customer in terms of both technical and
quality goals,
translate the customer's needs into specifications to produce the desired result,
consider any cost and schedule constraints within which project activities are
required to be performed, and
identify acceptance criteria for the result or measures of performance by which
customer satisfaction will be determined.
All projects involving the generation, acquisition and use of environmental data shall be
planned using a systematic planning process such as the Data Quality Objective process as
defined by the current revision of Guidance for Planning for Data Collection in Support of
Environmental Decision Making Using the Data Quality Objectives Process, EPA QA/G-4, or
acceptable alternate, and shall be documented in a Quality Assurance Project Plan (QAPP), as
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defined by the current revision of EPA Requirements for Quality Assurance Project Plans for
Environmental Data Operations, EPA QA/R-5, and approved by authorized QA personnel for
implementation.
TASK 1. GROUP ASSIGNMENT:
As a group, using the requirements from above, and the supporting rationale, revise this
QMP Section.
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Original Section 8:
8. IMPLEMENTATION OF WORK PROCESSES
8.1 Procedures for ensuring that work is performed according to plan
All ECWC Marine and Estuarine Division environmental data operations project will be imple-
mented in accordance with the Quality Assurance Project Plan. The ECWC Marine and
Estuarine Division Director meets quarterly with all Project Managers to review implementation
status of projects.
8.2 Level of management oversight and inspection
The level of oversight and inspection will be commensurate with the importance of particular
projects and the intended use of the data.
8.3 Procedures for appropriate routine, standardized, special, or critical operations
development and implementation
8.3.1 Identification of operations needing procedures
Operations requiring procedures are defined in the QAPP. If the procedures are standard
or routine they will be covered in depth in the ECWC Sampling Handbook, which will
be incorporated by reference into all QAPPs. ECWC SOPs, can be used in the same
manner where applicable.
8.3.2 Preparation of procedures
All special and critical operations procedures will be defined in the applicable QAPP in
detail.
8.3.3 Review and approval of procedures
All procedures will be approved by the Director ECWC Marine and Estuarine Division
prior to actual use. Special and critical operations procedures will be peer reviewed by
at least three Project Officers prior to submission for final approval.
Requirement; This section of the QMP shall describe the process of how and by whom work
shall be implemented by or on behalf of the organization. Minimally, the QMP must describe:
the procedures for ensuring that work is performed according to plan;
the needed level of management oversight and inspection that will be commen-
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Original Section 8:
8. IMPLEMENTATION OF WORK PROCESSES
8.1 Procedures for ensuring that work is performed according to plan
All ECWC Marine and Estuarine Division environmental data operations project will be imple-
mented in accordance with the Quality Assurance Project Plan. The ECWC Marine and
Estuarine Division Director meets quarterly with all Project Managers to review implementation
status of projects.
8.2 Level of management oversight and inspection
The level of oversight and inspection will be commensurate with the importance of particular
projects and the intended use of the data.
8.3 Procedures for appropriate routine, standardized, special, or critical operations
development and implementation
8.3.1 Identification of operations needing procedures
Operations requiring procedures are defined in the QAPP. If the procedures are standard
or routine they will be covered in depth in the ECWC Sampling Handbook, which will
be incorporated by reference into all QAPPs. ECWC SOPs, can be used in the same
manner where applicable.
8.3.2 Preparation of procedures
All special and critical operations procedures will be defined in the applicable QAPP in
detail.
8.3.3 Review and approval of procedures
All procedures will be approved by the Director ECWC Marine and Estuarine Division
prior to actual use. Special and critical operations procedures will be peer reviewed by
at least three Project Officers prior to submission for final approval.
Requirement; This section of the QMP shall describe the process of how and by whom work
shall be implemented by or on behalf of the organization. Minimally, the QMP must describe:
the procedures for ensuring that work is performed according to plan;
the needed level of management oversight and inspection that will be commen-
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surate with the importance of the particular project and the intended use of the project results;
and
o how procedures fbr appropriate routine, standardized, special, or critical
.operations are developed and implemented, including the policies and procedures
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.
The QMP must stress that environmental data operations project will be implemented in
accordance with the Quality Assurance Project Plan. The QMP shall consider those activities,
policies, and procedures that are common to all projects of the specific organization. It must
also emphasize the importance of documenting activities including any exceptions to the QA
Project Plan.
The organization shall 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.
TASK 1. GROUP ASSIGNMENT:
As a group, using the requirements from above, and the supporting rationale, revise this
QMP Section.
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Original Section 9:
9. QUALITY ASSESSMENT AND RESPONSE
Even the best QA plans are of limited .value unless they are implemented. In order to ensure
that QA plans are being implemented and that they are adequate, a series of technical and
managerial audits are necessary. These audits comprise the major mechanism of the ECWC
oversight. The QAPP must describe how and by whom assessments of environmental programs
are planned, conducted, and evaluated to measure the effectiveness of the implemented quality
system. The assessment tools for environmental programs encompass:
management systems reviews,
surveillances,
audits,
performance evaluations,
audits of data quality,
peer reviews and technical reviews,
readiness reviews, and
data quality assessments.
9.1 Planning, scheduling, and implementation of assessment and response to needed
changes
Project Officers have total responsibility for assessments of their projects.
9.2 Definition of responsibilities, levels of participation, and authority for staff
Coverage of these items is in section 9.4.
9.3 How, when, and by whom actions will be taken hi response to the findings of the
assessment, and how the effectiveness of the response will be determined.
Responses to assessment findings will be the responsibility of the Project QA Officer.
9.4 Ability of personnel conducting assessments 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;
independently confirm implementation and effectiveness of solutions; and
provide documented assurance to line management that, when problems are
identified, further work performed is monitored carefully until the problems are
suitably resolved.
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The personnel performing in-house management assessments are trained managers with years
of supervisory, managerial and administrative experience. The technical self-assessments will
be performed by Project Managers and Project Officers who are intimately familiar;with, the
.goals of the,project. The independent .technical .assessment will be performed by natural,
resource specialist with years of experience in their respective fields. As the assessors are fully
qualified professionals in their fields, any recommendations made will be considered by the
Project Managers and Project Officer of the particular project under assessment, and
implemented immediately, with approval of the Director.
External assessments will be performed by U.S. EPA QAMS Staff. Recommendations made
by QAMS will be considered by the Project Managers and Project Officer of the particular
project under assessment, and implemented immediately, with approval of the Director.
Requirement; Assessments are evaluations intended to increase the user's understanding of the
program or system being assessed, and to provide a basis for improving such programs or
systems. This section of the QMP must describe how and by whom assessments of environ-
mental programs are planned, conducted, and evaluated to measure the effectiveness of the
implemented quality system. This section of the QMP shall also describe how management
determines during planning which type of assessment activity is appropriate for a particular
project and which assessment tool is to be used. The assessment tools for environmental
programs encompass:
management systems reviews,
surveillances,
audits,
performance evaluations,
audits of data quality,
peer reviews and technical reviews,
readiness reviews, and
data quality assessments.
This section shall contain or address the following items pertaining to management
assessment of the effectiveness of the organization's Quality System:
how the process for the planning, scheduling, and implementation of assessments
works, as well as how the organization will respond to needed changes;
definition of responsibilities, levels of participation, and authorities for all
management and staff for the assessment process; and
discussion of how, when, and by whom actions will be taken in response to the
findings of the assessment, and how the effectiveness of the response will be
determined.
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Personnel conducting assessments shall be qualified based on project-specific
requirements to perform the assigned assessment. The QMP must describe how the level of
competence, experience, and training necessary to ensure the capabilitpof personnelconducting
assessments is determined. The QMP must document how persons conducting assessments must
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;
independently confirm implementation and effectiveness of solutions; and
provide documented assurance to line management that, when problems are
identified, further work performed is monitored carefully until the problems are
suitably resolved.
The QMP must clearly define the responsibilities and authorities of personnel conducting
assessments, particularly in regard to authority to suspend or stop work in progress upon
detection and identification of an immediate adverse condition affecting the quality of results or
the health and safety of personnel.
The QMP must describe how management will respond to the findings and recom-
mendations from assessments in a timely manner. When conditions needing corrective action
are identified, the appropriate response must be made promptly. The QMP should indicate how
follow-up action shall be taken and documented to confirm the implementation and effectiveness
of the response action.
Environmental data must be qualified according to the intended use of the data. Data
obtained from sources that did not use, or fully comply with, a QA Project Plan (or equivalent
planning document) for data collection must also be qualified. Data shall be qualified according
to procedures documented in the QMP. These procedures shall document the decision process
and factors used in arriving at the choice of the particular qualification method. This process
shall include the correct application of statistical methods during the assessment process. The
decision to qualify the data for their intended use shall be based on reconciliation with the
performance measures for the project defined by the data quality requirements. Any limitations
on data use shall be identified quantitatively to the extent practicable and fully documented.
The QMP shall also describe how project reports containing data or reporting the results
of environmental data operations shall be reviewed independently to confirm that the data or
results are presented correctly. The QMP shall describe the process used for these reviews and
the approval authority required prior to the publication or distribution of any reports.
The QMP shall also describe the process by which periodic assessments of environmental
programs are planned, scheduled and implemented. Line management is responsible for
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overseeing assessments and for responding to their findings. Scheduling of assessments and
allocation of resources are to be based on the status, risk and complexity of the sampling and
analytical activities.
TASK1. GROUP ASSIGNMENT:
As a group, using the requirements from above, and the supporting rationale, revise this
QMP Section.
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Original Section IQi
10. QUALITY IMPROVEMENT
This section Of the QMP includes a description of the ECWC Marine and Estuarine Division's
management system for detecting and preventing quality problems and for ensuring continuing
quality improvement.
10.1 Process and personnel responsible for identifying, planning, implementing, and
evaluating the effectiveness of quality improvement activities.
In the ECWC Marine and Estuarine Division the Quality Manager has total responsibility for
Quality Improvement. On each project the Project QA Officer has total responsibility for
Quality Improvement.
10.2 Corrective action program.
Each QAPP will define a method to ensure that conditions adverse to quality are identified
promptly and corrected as soon as practical. This Corrective Actions process shall include the
identification of root causes of problems, determining if the problem is unique or has more
generic implications, and recommending procedures to prevent recurrence.
Requirement: This section of the QMP shall include a description of the organization's
management system for detecting and preventing quality problems and for ensuring continuing
quality improvement. Accordingly, this, section shall describe:
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.
Corrective actions shall include the identification of root causes of problems, determining
if the problem is unique or has more generic implications, and recommending procedures to
prevent recurrence.
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TASK.l. GROUP ASSIGNMENT:
As a group, using the requirements from above, and the supporting rationale, revise this
QMP Section.
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Part C - E4 Workshop
Part C - Design, Construction, and Operation of
Environmental Technology
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PartC - E4 Workshop
(0) General
Part C elements used in conjunction with Part A for design,
construction, operation of environmental technology
Quality system elements for environmental technology that
- remediate contamination in environment
- prevent / remove pollutants from discharge
- dispose of / store contaminants
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Part C E4 Workshop
(0) General (cont'd)
Environmental technology includes
pollution control devices/systems
waste treatment processes/storage facilities
site remediation technology
Does not include
in-process pollution prevention/control devices
process modification
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Part C - E4 Workshop
(0) General (cont'd)
Program elements
- planning
- design of systems
- construction/fabrication of systems and components
- operation of systems
- quality assessment and response
- verification and acceptance of systems
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Part C - E4
(1) Planning - Specifications
All activities and projects for design, construction, operation of
environmental technology shall be
planned
documented
must involve key users, customers of system and technical staff
Planning/design subject to review for conformance to technical
and quality requirements
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Part C - E4 Workshop
(1) Planning - Specifications (cont'd)
Project planning - coordinate among organizations
- following elements
acceptable criteria for completed systems
delivery, handling, storage, identification, inspection,
testing, installation requirements
notify involved organization in project and role in
design, construction, operation, assessment
personnel, equipment required
program/task scope and objectives
reviews, assessments
QA/project records
technical, performance, regulatory quality standards
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Part C - E4 Workshop
(1) Planning - Specifications (cont'dj
Document project planning in work plans, QAPPs, design
criteria, schedules, drawings
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Part C - E4 Workshop
(2) Design of Systems
Purpose and Background
- To provide quality management practices and criteria for
the design of environmental technology systems
- Goal is to ensure that the technology systems are designed
using sound engineering and scientific principles and
appropriate standards
- Derived primarily from ISO-9004 and ASME NQA-1
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Part C - E4 Workshop
(2) Design of Systems (cont'd)
Specifications
- The results of the design (including changes) shall be
defined, controlled to the extent required, verified, and
documented
- Design documents shall specify necessary technical and
?PJ« ny»fiCC5Iitance.Fiteria as we» as the inspections and
tests needed to verify acceptable construction and
operation
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Part C - E4 Workshop
(2) Design of Systems (cont'd)
Specifications (cont'd)
~ F»nal design shall be verified formally and documented,
and design adequacy verified by independent authorities
- Readiness reviews shall be performed prior to
implementation of the design
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(2) Design of Systems (cont'd)
The design process shall ensure that the control of design
mouts processes, outputs, configuration changes, interfaces
'""lion), and records provide for
- ability of components and systems to perform under
expected conditions of use
- ability of components and systems to safely respond to
unexpected conditions (such as accidents and equipment
tenures), including consideration of redundant systems or
otner safeguards j
- acceptance/rejection criteria for components and syst
ems
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Part C - E4 Workshop
(2) Design of Systems (cont'd)
The design process shall ensure that the control of design
inputs, processes, outputs, configuration changes, interfaces
(coordination), and records provide for
- agreement of customer needs expressed during planning
with technical specifications for materials, items, and
services, including delivery documentation requirements
any constraints of cost or schedule that apply
- compliance with regulatory requirements, national
standards and codes, and organizational engineering
practices
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(2) Design of Systems (cont'd)
The design process shall ensure that the control of design
inputs, processes, outputs, configuration changes interfaces
(coordination), and records provide for
- considerations of unintended uses and misuses
- effective coordination and interfacing of organizations
participating in the design process
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Part C - E4 Workshop
(2) Design of Systems (cont'd)
The design process shall ensure that the control of design
inputs, processes, outputs, configuration changes, interfaces
(coordination), and records provide for
- production of verified, reviewed, and approved design
outputs in a timely manner
- safety, reliability, serviceability, and maintainability
requirements
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(2) Design of Systems (cont'd)
Guidelines
- The design review process should ensure that all necessary
design documents, drawings, guides, instructions,
specifications, and data sheets are documented and
reviewed, approved by authorize^ personnel, and are
distributed to personnel performing the work
- The design review should identify anticipated problems or
inadequacies and corrective actions
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Part C - E4 Workshop
(2) Design of Systems (cont'd)
Guidelines (cont'd)
- Design verification should be conducted prior to
subsequent critical staged of development to ensure timely
correction of deficient conditions
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Part C - E4 Workshop
(3) Construction/Fabrication of Systems and Components
Purpose and Scope
- To provide quality management practices and criteria for
the construction arid fabrication of systems and
components based on the design documents provided
- Goal is to ensure that items, systems, components meet the
needs and function as defined in design documents
- Derived primarily from ISO-9004 and ASME NQA-1
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Part C - E4 Workshop
(3) Construction/Fabrication of Systems and Components (cont'd)
Specifications
- Construction shall be performed
under appropriate controlled conditions
in accordance with approved drawings and
specifications
- Only qualified and accepted items and services shall be
used and installed as indicated by design
- Items shall be identified as to their acceptability (directly or
indirectly)
- Inspections and tests shall be performed during
construction/fabrication to assure conformity to design
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Part C - E4 Workshop
(3) Construction/Fabrication of Systems and Components (cont'd)
Specifications (cont'd)
- Handling, storage, cleaning, packaging, shipping and
preservation of equipment shall be controlled to prevent
loss damage or deterioration
- Periodic preventatiye and corrective maintenance shall be
performed in accordance with design or manufacturer's
specifications during construction and fabrication to ensure
satisfactory performance
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Part C - E4 Workshop
(3) Construction/Fabrication of Systems and Components (cont'd)
Specifications (cont'd)
- M&TE used during construction shall be
of the proper type, range and accuracy
calibrated and maintained
- The basis for calibration shall be documented
- Documentation of calibration shall be maintained and
traceable to the equipment calibrated
- M&TE found unsatisfactory shall be repaired,
recalibrated, and certified within tolerances prior to being
used
The validity of measurements made without
calibration equipment shall be evaluated and repeated
as required
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Part C *. E4 Workshop
(3) Construction/Fabrication of Systems and Components (cont'd)
Specifications (cont'd)
- Inspection and test procedures shall include test objectives,
test personnel requirements, test equipment, acceptance
criteria, and disposition of unacceptable items
- The results of tests and inspections, including the
applicable procedures, shall be documented and
maintained
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Part C - E4 Workshop
(3) Construction/Fabrication of Systems and Components (contfd)
Guidelines
- Items in storage subject to time-based deterioration should!
be checked periodically to detect possible deterioration and
corrective action performed as appropriate
- As-built drawings should be prepared when such
information is required for operation
- Calibration and control measures may not be required for
M&TE when normal commercial availability provides
required accuracy (rulers, tape measures, levels*...)
- Traceability to nationally recognized performance
standards (not required) should be maintained when they
are used
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Part C - E4 Workshop
(4) Operation of Systems
Purpose and Scope
- To provide quality management practices and criteria for
the operation of systems and components based on the
design documents provided
- Goal is to ensure that items, systems, components are
operated and function as defined in design documents
- Derived primarily from ISO-9004 and ASME NQA-1
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Part C - E4 Workshop
(4) Operation of Systems (cont'd)
Specifications
- Environmental technology shall be operated in accordance
with design document requirements and operating
instructions and guides. Operating guides include
material controls
configuration management
operating procedures, including control limits and
safety limits
process control during abnormal and fault conditions
special environmental conditions
personnel skill, capability, knowledge, and proficiency
requirements
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Part C E4 Workshop
(4) Operation of Systems (cont'd)
Specifications (cont'd)
- Auxiliary materials, utilities, and consumables shall be controlled and
verified periodically wh&i required to ensure uniformity and quality
- Status indicators shall be provided indicating operating status and limits.
- Status indicators shall be used to prevent inadvertent operation or
removal from operation when such actions
affect operational safety^
present an environmental hazard
violate state or regulatory requirements
jeopardize the goals of a project (such situations include loss qf data
that are difficult or expensive to reproduce)
- Items shall be identified as to their acceptability (directly or indirectly)
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Part C - E4 Workshop
(5) Assessment and Response
Purpose and Background
- To provide quality management practices and criteria for
the assessment of activities during the design, construction
and operation of environmental technology
- Goal is to ensure that approved planning requirements,
design specifications, and operating guides are
implemented as prescribed
- Derived primarily from ISO-9004 and ASME NQA-1
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Part C - E4 Workshop
(5) Assessment and Response (cont'd)
Specifications
- Assessments shall be performed regularly during design,
construction, and operation
- Appropriate corrective actions must be taken in response
to findings and their adequacy verified and documented
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Part C - E4 Workshop
(5) Assessment and Response (cont'd)
Guidelines
- Assessments may include surveillances, peer reviews,
readiness reviews, and audits
- Frequency of assessments should be appropriate to the
circumstances or as required in the planning
documentation
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Part C - E<
(6) Verification and Acceptance of Systems
Purpose and Background
- To provide quality management practices and criteria for
the verification and acceptance of environmental
technology following design and construction and prior to
operation
- Goal is to ensure that environmental technology performs
as prescribed in the design specifications and is acceptable
for its intended use
- Derived primarily from ISO-9004 and ASME NQA-1
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Part C - E4 Workshop
(6) Verification and Acceptance of Systems (cont'd)
Specifications
- Performance of environmental technology shall be verified
prior to its routine use
- When performance measurement involves environmental
data operations, the requirements of Part B shall be
followed
- Deficiencies shall be corrected and the effectiveness of the
corrective actions confirmed and documented
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QUALITY ASSURANCE PROJECT PLANS
Definition:
Quality Assurance Project Plan (QAPFl - 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.
What it does:
- Ensures project management commitment and involvement;
- Provides a specific plan of QA/QC requirements for the project;
- Assures project is implemented as planned;
- Defines oversight requirements for a project;
- Defines assessment requirements for a project;
- Provides for a continuous improvement capability;
- Satisfies CFR requirements for a QAPP.
Criteria:
EPA Requirements for Quality Assurance Project Plans. EPA QA/R-5
(Replacing Guidance and Specifications for Preparing Quality Assurance
Project Plans. QAMS-005/80
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NOTES
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United States Office of Environmental EPA/240/B-01/003
Environmental Protection Information March 2001
Agency Washington, DC 20460
&EPA EPA Requirements for Quality
Assurance Project Plans
EPA QA/R-5
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FOREWORD
The U.S. Environmental Protection Agency (EPA) has developed the Quality Assurance
Project Plan (QA Project Plan) as a tool for project managers and planners to document the type
and quality of data needed for environmental decisions and to describe the methods for collecting
and assessing those data. The development, review, approval, and implementation of the QA
Project Plan is part of EPA's mandatory Quality System. The EPA Quality System requires all
organizations to develop and operate management structures and processes to ensure that data
used in Agency decisions are of the type and quality needed for their intended use. The QA
Project Plan is an integral part of the fundamental principles and practices that form the
foundation of the EPA Quality System.
This document provides the QA Project Plan requirements for organizations that conduct
environmental data operations on behalf of EPA through contracts, financial assistance
agreements, and interagericy agreements; however, it may be used by EPA as well. It contains the
same requirements as Chapter 5 of EPA Order 5360 Al (EPA 2000), The EPA Quality Manual
for Environmental Programs, which has been developed for internal use by EPA organizations.
A companion document, EPA Guidance for Quality Assurance Project Plans (QA/G-5) (EPA
1998) provides suggestions for both EPA and non-EPA organizations on preparing, reviewing,
and implementing QA Project Plans that satisfy the requirements defined in this document.
This document is one of the EPA Quality System Series documents which describe EPA
policies and procedures for planning, implementing, and assessing the effectiveness of a quality
system. Questions regarding this document or other EPA Quality System Series documents
should be directed to:
U.S. EPA
Quality Staff (2811R)
Washington, DC 20460
Phone: (202) 564-6830
FAX: (202)565-2441
e-mail: quality@epa.gov
Copies of Quality System Series documents may be obtained from the Quality Staffer by
downloading them from the Quality Staff Home Page:
www.epa.gov/quality
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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 QA PROJECT PLANS, THE EPA QUALITY SYSTEM, AND
ANSI/ASQC E4-1994 '.... 2
1.3 THE GRADED APPROACH AND THE EPA QUALITY SYSTEM 4
1.4 INTENDED AUDIENCE 4
1.5 PERIOD OF APPLICABILITY 4
1.6 ADDITIONAL RESOURCES 4
1.7 SUPERSESSION 5
CHAPTER2. QA PROJECT PLAN REQUIREMENTS 7
2.1 POLICY 7
2.2 PURPOSE 7
2.3 APPLICABILITY 7
2.4 GENERAL CONTENT AND DETAIL REQUIREMENTS 7
2.4.1 General Content 7
2.4.2 Level of Detail : 8
2,5 QA PROJECT PLAN PREPARATION AND APPROVAL 8
2.6 QA PROJECT PLAN IMPLEMENTATION 9
2.7 QA PROJECT PLAN REVISION 9
CHAPTERS. QA PROJECT PLAN ELEMENTS 11
3.1 CONTENT REQUIREMENTS 11
3.2 GROUP A: PROJECT MANAGEMENT 12
3.2.1 Al - Title and Approval Sheet 13
3.2.2 A2 - Table of Contents 13
3.2.3 A3 - Distribution List 14
3.2.4 A4 - Project/Task Organization 14
3.2.5 A5 - Problem Definition/Background 14
3.2.6 A6 - Project/Task Description 14
3.2.7 A7 - Quality Objectives and Criteria 15
3.2.8 A8 - Special Training/Certification 15
3.2.9 A9 - Documents and Records 15
3.3 GROUP B: DATA GENERATION AND ACQUISITION 15
3.3.1 Bl- Sampling Process Design (Experimental Design) 16
3.3.2 B2 - Sampling Methods 17
3.3.3 B3 - Sample Handling and Custody 17
3.3.4 B4 - Analytical Methods 17
3.3.5 B5 - Quality Control 18
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3.3.6 B6 - Instrument/Equipment Testing, Inspection, and Maintenance 18
3.3.7 B7 - Instalment/Equipment Calibration and Frequency 18
3.3.8 B8 - Inspection/Acceptance of Supplies and Consumables 19
3.3.9 B9 - Non-direct Measurements 19
3.3.10 BIO - Data Management 19
3.4 GROUP C: ASSESSMENT AND OVERSIGHT 20
3.4.1 Cl - Assessments and Response Actions 20
3.4.2 C2 - Reports to Management 20
3.5 GROUP D: DATA VALIDATION AND USABILITY 21
3.5.1 Dl - Data Review, Verification, and Validation 21
3.5.2 D2 - Verification and Validation Methods 21
3.5.3 D3 - Reconciliation with User Requirements 21
REFERENCES 23
APPENDIX A. CROSSWALKS AMONG QUALITY ASSURANCE DOCUMENTS .A-l
Al BACKGROUND A-l
A.2 CROSSWALK BETWEEN EPA QA/R-5 AND QAMS-005/80 A-l
A3 CROSSWALK BETWEEN THE DQO PROCESS
AND THE QAPROJECT PLAN A-3
APPENDIX B. TERMS AND DEFINITIONS B-l
FIGURES
Page
1. EPA Quality System Components and Tools 3
2. Example Document Control Format 14
TABLES
Page
1. Group A: Project Management Elements 13
2. Group B: Data Generation and Acquisition Elements 16
3. Group C: Assessment and Oversight Elements 20
4. Group D: Data Validation and Usability Elements 21
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CHAPTER 1
INTRODUCTION
1.1 BACKGROUND
Environmental programs conducted by or funded by the U.S. Environmental Protection
Agency (EPA) involve many .diverse activities that address complex environmental issues. The
EPA annually spends several hundred million dollars in the collection of environmental data for
scientific research and regulatory decision making. In addition, non-EPA organizations may
spend as much as an order of magnitude more each year to respond to Agency requirements. If
decision makers (EPA and otherwise) are to have confidence in the quality of environmental data
used to support their decisions, there must be a structured process for quality hi place.
A structured system that describes the policies and procedures for ensuring that work
processes, products, or services satisfy stated expectations or specifications is called a quality
system. All organizations conducting environmental programs funded by EPA are required to
establish and implement a quality system. EPA also requires that all environmental data used in
decision making be supported by an approved Quality Assurance Project Plan (QA Project Plan).
This requirement is defined in EPA Order 5360.1 A2 (EPA 2000), Policy and Program
Requirements for the Mandatory Agency-wide Quality System, for EPA organizations. Non-EPA
organizations funded by EPA are required to develop a QA Project Plan through:
48 CFR 46, for contractors;
40 CFR 30, 31, and 35 for assistance agreement recipients; and
other mechanisms, such as consent agreements in enforcement actions.
The QA Project Plan integrates all technical and quality aspects of a project, including
planning, implementation, and assessment. The purpose of the QA Project Plan is to document
planning results for environmental data operations and to provide a project-specific "blueprint"
for obtaining the type and quality of environmental data needed for a specific decision or use. The
QA Project Plan documents how quality assurance (QA) and quality control (QC) are applied to
an environmental data operation to assure that the results obtained are of the type and quality
needed and expected.
The ultimate success of an environmental program or project depends on the quality of the
environmental data collected and used in decision-making, and this may depend significantly on
the adequacy of the QA Project Plan and its effective implementation. Stakeholders (i.e., the data
users, data producers, decision makers, etc.) shall be involved in the planning process for a
program or project to ensure that their needs are defined adequately and addressed. While time
spent on such planning may seem unproductive and costly, the penalty for ineffective planning
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includes greater cost and lost time. Therefore, EPA requires that a systematic planning process be
used to plan all environmental data operations. To support this requirement, EPA has developed
a process called the Data Quality Objectives (DQO) Process. The DQO Process is the Agency's
preferred planning process and is described in the Guidance for the Data Quality Objectives
Process (QA/G-4) (EPA 2000b). The QA Project Plan documents the outputs from systematic
planning.
This requirements document presents specifications and instructions for the information
that must be contained in a QA Project Plan for environmental data operations funded by EPA
The document also discusses the procedures for review, approval, implementation, and revision of
QA Project Plans. Users of this document should assume that all of the elements described herein
are required in a QA Project Plan unless otherwise directed by EPA.
1.2 QA PROJECT PLANS, THE EPA QUALITY SYSTEM, AND ANSI/ASQC
E4-1994
EPA Order 5360.1 A2 and the applicable Federal regulations (defined above) establish a
mandatory Quality System that applies to all EPA organizations and organizations funded by
EPA Components of the EPA Quality System are illustrated in Figure 1. Organizations must
ensure that data collected for the characterization of environmental processes and conditions are
of the appropriate type and quality for their intended use and that environmental technologies are
designed, constructed, and operated according to defined expectations. The QA Project Plan is a
key project-level component of the EPA Quality System.
EPA policy is based on the national consensus standard, ANSI/ASQC E4-1994,
Specifications and Guidelines for Environmental Data Collection and Environmental
Technology Programs, The ANSI/ASQC E4-1994 standard describes the necessary management
and technical elements for developing and implementing a quality system. This standard
recommends using a tiered approach to a quality system. This standard recommends first
documenting each organization-wide quality system in a Quality Management Plan or Quality
Manual (to address requirements of Part A: Management Systems of the standard) and then
documenting the applicability of the quality system to technical activity-specific efforts in a QA
Project Plan or similar document (to address the requirements of Part B: Collection and
Evaluation of Environmental Data of the standard). EPA has adopted this tiered approach for its
mandatory Agency-wide Quality System. This document addresses Part B requirements of the
standard.
A Quality Management Plan, or equivalent Quality Manual, documents how an
organization structures its quality system, defines and assigns5QA and QC responsibilities, and
describes the processes and procedures used to plan, implement, and assess the effectiveness of
the quality system. The Quality Management Plan may be viewed as the "umbrella" document
under which individual projects are conducted. EPA requirements for Quality Management Plans
are defined in EPA Requirements for Quality Management Plans (QA/R-2) (EPA 2001). The
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o
D.
Consensus Standards
ANSI/ASQC E4
ISO 9000 Series
Internal EPA Policies
EPA Order 5360.1
EPA Manual 5360
External Policies
Contracts - 48 CFR 46
Assistance Agreements -
40 CFR 30. 31. and 35
EPA Program &
Regional Policy
Supporting System Elements
(e.g.. Procurements,
Computer Hardware/Software)
Training/Communication
(e.g.. Training Plan,
Conferences)
Systematic
Planning
(e.g., DQO Process)
||>>Xconduct Study/\
^^s. Experiment ;/
Standard
Operating
Procedures
1
Technical
Assessments
PLANNING
i
-- IMPLEMENTATION
--» ASSESSMENT
Defensible Products and Decisions
Figure 1. EPA Quality System Components and Tools
EPA QA/R-5
3
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Quality Management Plan is then supported by project-specific QA Project Plans. In some cases,
a QA Project Plan and a Quality Management Plan may be combined into a single document that
contains both organizational and project-specific elements. The QA Manager for the EPA
organization sponsoring the work has the authority to determine when a single document is
applicable and will define the content requirements of such a document.
1.3 THE GRADED APPROACH AND THE EPA QUALITY SYSTEM
Recognizing that a "one size fits all" approach to quality requirements will not work in
organizations as diverse as EPA, implementation of the EPA Quality System is based on the
principle of graded approach. Applying a graded approach means that quality systems for
different organizations and programs will vary according to the specific objectives and needs of
the organization. For example, the quality expectations of a fundamental research program are
different from that of a regulatory compliance program because the purpose or intended use of the
data is different. The specific application of the graded approach principle to QA Project Plans is
described in Section 2.4.2.
1.4 INTENDED AUDIENCE
This document specifies the requirements for developing QA Project Plans for
organizations that conduct environmental data operations funded by EPA through contracts,
financial assistance agreements, and interagency agreements. EPA organizations may also use this
document to develop QA Project Plans since this document is clearer and more user-friendly than
the equivalent requirements defined in Section 5.3 of EPA Order 5360 Al (EPA 2000), The EPA
Quality Manual for Environmental Programs (an internal policy document). However, the
preparation, submission, review, and approval requirements for EPA organizations are still
contained in Section 5.2 of EPA Order 5360 Al as these represent internal EPA policy.
1.5 PERIOD OF APPLICABILITY
This document shall be valid for a period of up to five years from the official date of
publication. After five years, it shall either be reissued without change, revised, or withdrawn
from the EPA Quality System.
1.6 ADDITIONAL RESOURCES
Guidance on preparing QA Project Plans may be found in a companion document, EPA
Guidance for Quality Assurance Project Plans (QA/G-5) (EPA 1998). This guidance discusses
the application of the QA Project Plan requirements and provides examples. Other documents
that provide guidance on activities critical to successful environmental data operations and
complement the QA Project Plan preparation effort include:
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Guidance for the Data Quality Objectives Process (QA/G-4), (EPA 2000b)
Guidance for the Preparation of Standard Operating Procedures for Quality-
Related Documents (QA/G-6), (EPA 1995)
Guidance for Data Quality Assessment: Practical Methods for Data Analysis
(QA/G-9), (EPA 2000a)
1.7 SUPERSESSION
This document replaces QAMS-005/80, Interim Guidelines and Specifications for
Preparing Quality Assurance Project Plans (EPA 1980) in its entirety.
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CHAPTER 2
QA PROJECT PLAN REQUIREMENTS
2.1 POLICY
All work funded by EPA that involves the acquisition of environmental data generated
from direct measurement activities, collected from other sources, or compiled from computerized
data bases and information systems shall be implemented in accordance with an approved QA
Project Plan. The QA Project Plan will be developed using a systematic planning process based
on the graded approach. No work covered by this requirement shall be implemented without an
approved QA Project Plan available prior to the start of the work except under circumstances
requiring immediate action to protect human health and the environment or operations conducted
under police powers.
2.2 PURPOSE
The QA Project Plan documents the planning, implementation, and assessment procedures
of, and how specific QA and QC activities will be applied during a particular project. The QA
Project Plan demonstrates conformance to Part B requirements of ANSI/ASQC E4-1994.
2.3 APPLICABILITY
These requirements apply to all environmental programs funded by EPA that acquire,
generate, or compile environmental data including work performed through contracts, work
assignments, delivery orders, task orders, cooperative agreements, interagency agreements, State-
EPA agreements, State, local and Tribal Financial Assistance/Grants, Research Grants, and in
response to statutory or regulatory requirements and consent agreements. These requirements are
negotiated into interagency agreements, including sub-agreements, and, in some cases, are
included in enforcement settlement and consent agreements and orders. Where specific Federal
regulations require the application of QA and QC activities (see Section 1.1), QA Project Plans
shall be prepared, reviewed, and approved in accordance with the specifications contained in this
document unless explicitly superseded by the regulation.
2.4 GENERAL CONTENT AND DETAIL REQUIREMENTS
2.4.1 General Content
The QA Project Plan must be composed of standardized, recognizable elements covering
the entire project from planning, through implementation, to assessment. Chapter 3 of this
document describes specific elements to address for QA Project Plans submitted to EPA_ In some
cases, it may be necessary to add special requirements to the QA Project Plan. The EPA
organization sponsoring the work has the authority to define any special requirements beyond
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those listed in this document. If no additional requirements are specified, the QA Project Plan
shall address all required elements. Each EPA organization defines their organizational-specific
requirements for QA Project Plan documentation in their Quality Management Plan. All
applicable elements defined by the EPA organization sponsoring the work must be addressed.
While most QA Project Plans will describe project- or task-specific activities, there may be
occasions when a generic QA Project Plan may be more appropriate. A generic QA Project Plan
addresses the general, common activities of a program that are to be conducted at multiple
locations or over a long period of time; for example, it may be useful for a large monitoring
program that uses the same methodology at different locations. A generic QA Project Plan
describes, in a single document, the information that is not site or time-specific but applies
throughout the program. Application-specific information is then added to the approved QA
Project Plan as that information becomes known or completely defined. A generic QA Project
Plan shall be reviewed periodically to ensure that its content continues to be valid and applicable
to the program over time.
2.4.2 Level of Detail
The level of detail of the QA Project Plan should be based on a graded approach so that
the level of detail in each QA Project Plan will vary according to the nature of the work being
performed and the intended use of the data. As a result, an acceptable Q A Project Plan for some
environmental data operations may require a qualitative discussion of the experimental process
and its objectives while others may require extensive documentation to adequately describe a
complex environmental program.
2.5 QA PROJECT PLAN PREPARATION AND APPROVAL
The QA Project Plan may be prepared by an EPA organization, a contractor, an assistance
agreement holder, or another Federal agency under an interagency agreement. Except where
specifically delegated in the Quality Management Plan of the EPA organization sponsoring the
work, all QA Project Plans prepared by non-EPA organizations must be approved by EPA before
implementation.
The QA Project Plan shall be reviewed and approved by an authorized EPA reviewer to
ensure that the QA Project Plan contains the appropriate content and level of detail. The
authorized reviewer, for example the EPA project manager1 with the assistance and approval of
the EPA QA Manager or by the EPA QA Manager alone, are defined by the EPA organization's
Quality Management Plan. In some cases, the authority to review and approve QA Project Plans
is delegated to another part of the EPA organization covered by the same Quality Management
1 This term refers to the EPA official responsible for the project. This individual may also be called Project Officer,
Delivery Order Project Officer, Work Assignment Manager, or Principal Investigator.
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Plan. In cases where the authority to review and approve QA Project Plans is delegated in writing
by EPA to another organization (i.e., a Federal agency or a State under an EPA-approved Quality
Management Plan when the environmental data operation itself has been delegated to that
organization for implementation), it is possible that the EPA project manager and EPA QA
Manager may not be involved in the review and approval steps.
2.6 QA PROJECT PLAN IMPLEMENTATION
None of the environmental work addressed by the QA Project Plan shall be started until
the QA Project Plan has been approved and distributed to project personnel except in situations
requiring immediate action to protect human health and the environment or operations conducted
under police powers. Subject to these exceptions, it is the responsibility of the organization
performing the work to assure that no environmental data are generated or acquired before the
QA Project Plan is approved and received by the appropriate project personnel. However, EPA
may grant conditional approval to a QA Project Plan to permit some work to begin while non-
critical deficiencies in the QA Project Plan are being resolved.
The organization performing the work shall ensure that the QA Project Plan is
implemented as approved and that all personnel involved in the work have direct access to a
current version of the QA Project Plan and all other necessary planning, implementation, and
assessment documents. These personnel should understand the requirements prior to the start of
data generation activities.
2.7 QA PROJECT PLAN REVISION
Although the approved QA Project Plan must be implemented as prescribed; it is not
inflexible. Because of the complex and diverse nature of environmental data operations, changes
to original plans are often needed. When such changes occur, the approving official shall
determine if the change significantly impacts the technical and quality objectives of the project.
When a substantive change is warranted, the originator of the QA Project Plan shall modify the
QA Project Plan to document the change and submit the revision for approval by the same
authorities that performed the original review. Only after the revision has been received and
approved (at least verbally with written follow-up) by project personnel, shall the change be
implemented.
For programs or projects of long duration, such as multi-year monitoring programs or
projects using a generic QA Project Plan, the QA Project Plans shall be reviewed at least annually
by the EPA Project Manager (or authorized representative). When revisions are necessary, the
QA Project Plan must be revised and resubmitted for review and approval.
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CHAPTERS
QA PROJECT PLAN ELEMENTS
3.1 CONTENT REQUIREMENTS
The QA Project Plan is a formal document describing in comprehensive detail the
necessary QA, QC, and other technical activities that must be implemented to ensure that the
results of the work performed will satisfy the stated performance criteria. The QA Project Plan
must provide sufficient detail to demonstrate that:
the project technical and quality objectives are identified and agreed upon;
the intended measurements, data generation, or data acquisition methods are
appropriate for achieving project objectives;
assessment procedures are sufficient for confirming that data of the type and
quality needed and expected are obtained; and
any limitations on the use of the data can be identified and documented.
Most environmental data operations require the coordinated efforts of many individuals, including
managers, engineers, scientists, statisticians, and others. The QA Project Plan must integrate the
contributions and requirements of everyone involved into a clear, concise statement of what is to
be accomplished, how it will be done, and by whom. It must provide understandable instructions
to those who must implement the QA Project Plan, such as the field sampling team, the analytical
laboratory, modelers, and the data reviewers. In all aspects of the QA Project Plan, the use of
national consensus standards and practices are encouraged.
In order to be effective, the QA Project Plan must specify the level or degree of QA and
QC activities needed for the particular environmental data operations. Because this will vary
according to the purpose and type of work being done, EPA believes that the graded approach
should be used in planning the work. This means that the QA and QC activities applied to a
project will be commensurate with:
the purpose of the environmental data operation (e.g., enforcement, research and
development, rulemaking),
the type of work to be done (e.g., pollutant monitoring, site characterization, risk
characterization, bench level proof of concept experiments), and
the intended use of the results (e.g., compliance determination, selection of
remedial technology, development of environmental regulation).
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The QA Project Plan shall be composed of standardized, recognizable elements covering
the entire project from planning, through implementation, to assessment. These elements are
presented in that order and have been arranged for convenience into four general groups. The
four groups of elements and their intent are summarized as follows:
A Project Management - The elements in this group address the basic area of project
management, including the project history and objectives, roles and responsibilities
of the participants, etc. These elements ensure that the project has a defined goal,
that the participants understand the goal and the approach to be used, and that the
planning outputs have been documented.
B Data Generation and Acquisition - The elements in this group address all aspects
of project design and implementation. Implementation of these elements ensure
that appropriate methods for sampling, measurement and analysis, data collection
or generation, data handling, and QC activities are employed and are properly
documented.
C Assessment and Oversight - The elements in this group address the activities for
assessing the effectiveness of the implementation of the project and associated QA
and QC activities. The purpose of assessment is to ensure that the QA Project
Plan is implemented as prescribed.
D Data Validation and Usability - The elements in this group address the QA
activities that occur after the data collection or generation phase of the project is
completed. Implementation of these elements ensures that the data conform to the
specified criteria, thus achieving the project objectives.
All applicable elements, including the content and level of detail under each element,
defined by the EPA organization sponsoring the work must be addressed in the QA Project Plan.
If an element is not applicable, state this in the QA Project Plan. Documentation, such as an
approved Work Plan, Standard Operating Procedures, etc., may, be referenced in response to a
particular required QA Project Plan element to reduce the size of the QA Project Plan. Current
versions of all referenced documents must be attached to the QA Project Plan itself or be placed
on file with the appropriate EPA office and available for routine referencing when needed. The
QA Project Plan shall also address related QA planning documentation (e.g., Quality Management
Plans) from suppliers of services critical to the technical and quality objectives of the project or
task.
3.2 GROUP A: PROJECT MANAGEMENT
The elements in this group (Table 1) address project management, including project
history and objectives, roles and responsibilities of the participants, etc. These elements document
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that the project has a defined goal, that the participants understand the goal and the approach to
be used, and that the planning outputs have been documented.
Table 1. Group A: Project Management Elements
Al
A2
A3
A4
A5
A6
A7
A8
A9
Title and Approval Sheet
Table of Contents
Distribution List
Project/Task Organization
Problem Definition/Background
Project/Task Description
Quality Objectives and Criteria
Special Training/Certification
Documents and Records
3.2.1 Al - Title and Approval Sheet
On the Title and Approval Sheet, include the title of the plan, the name of the
organization(s) implementing the project, the effective date of the plan, and the names, titles,
signatures, and approval dates of appropriate approving officials. Approving officials may
include:
Organization's Project Manager
Organization's QA Manager
EPA Project Manager
EPA QA Manager
Others, as needed (e.g., field operations manager, laboratory managers,
State and other Federal agency officials)
3.2.2 A2 - Table of Contents
Provide a table of contents for the document, including sections, figures, tables,
references, and appendices. Apply a document control format (Figure 2) on each page following
the Title and Approval Sheet when required by the EPA Project Manager and QA Manager.
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Section No. _
Revision No.
Date
Page of
Figure 2. Example Document Control Format
3.2.3 A3 - Distribution List
List the individuals and their organizations who need copies of the approved QA Project
Plan and any subsequent revisions, including all persons responsible for implementation (e.g.,
project managers), the QA managers, and representatives of all groups involved. Paper copies
need not be provided to individuals if equivalent electronic information systems can be used.
3.2.4 A4 - Project/Task Organization
Identify the individuals or organizations participating in the project and discuss their
specific roles and responsibilities. Include the principal data users, the decision makers, the
project QA manager, and all persons responsible for implementation. The project quality
assurance manager must be independent of the unit generating the data. (This does not include
being independent of senior officials, such as corporate managers or agency administrators, who
are nominally, but not functionally, involved in data generation, data use, or decision making.)
Identify the individual responsible for maintaining the official, approved QA Project Plan.
Provide a concise organization chart showing the relationships and the lines of
communication among all project participants. Include other data users who are outside of the
organization generating the data, but for whom the data are nevertheless intended. The
organization chart must also identify any subcontractor relationships relevant to environmental
data operations, including laboratories providing analytical services.
3.2.5 A5 - Problem Definition/Background
State the specific problem to be solved, decision to be made, or outcome to be achieved.
Include sufficient background information to provide a historical, scientific, and regulatory
perspective for this particular project.
3.2.6 A6 - Project/Task Description
Provide a summary of all work to be performed, products to be produced, and the
schedule for implementation. Provide maps or tables that show or state the geographic locations
of field tasks. This discussion need not be lengthy or overly detailed, but should give an overall
picture of how the project will resolve the problem or question described in A5.
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3.2.7 A7 - Quality Objectives and Criteria
Discuss the quality objectives for the project and the performance criteria to achieve those
objectives. EPA requires the use of a systematic planning process to define these quality
objectives and performance criteria.
3.2.8 A8 - Special Training/Certification
Identify and describe any specialized training or certifications needed by personnel in order
to successfully complete the project or task. Discuss how such training will be provided and how
the necessary skills will be assured and documented.
3.2.9 A9 - Documents and Records
Describe the process and responsibilities for ensuring the appropriate project personnel
have the most current approved version of the QA Project Plan, including version control,-
updates, distribution, and disposition.
Itemize the information and records which must be included in the data report package
and specify the reporting format for hard copy and any electronic forms. Records can include raw
data, data from other sources such as data bases or literature, field logs, sample preparation and
analysis logs, instrument printouts, model input and output files, and results of calibration and QC
checks.
Identify any other records and documents applicable to the project that will be produced,
such as audit reports, interim progress reports, and final reports. Specify the level of detail of the
field sampling, laboratory analysis, literature or data base data collection, or modeling documents
or records needed to provide a complete description of any difficulties encountered.
Specify or reference all applicable requirements for the final disposition of records and
documents, including location and length of retention period.
3.3 GROUP B: DATA GENERATION AND ACQUISITION
The elements in this group (Table 2) address all aspects of data generation and acquisition
to ensure that appropriate methods for sampling, measurement and analysis, data collection or
generation, data handling, and QC activities are employed and documented. The following QA
Project Plan elements describe the requirements related to the actual methods or methodology to
be used for the:
collection, handling, and analysis of samples;
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data obtained from other sources (e.g., contained in a computer data base from
previous sampling activities, compiled from surveys, taken from the literature); and
the management (i.e., compiling, handling) of the data.
The methods described in these elements should have been summarized earlier in element A6. The
purpose here is to provide detailed information on the methods. If the designated methods are
well documented and are readily available to all project participants, citations are adequate;
otherwise, detailed copies of the methods and/or SOPs must accompany the QA Project Plan
either in the text or as attachments.
Table 2. Group B: Data Generation and
Acquisition Elements
Bl
B2
B3
B4
B5
B6
B7
B8
B9
BIO
Sampling Process Design (Experimental Design)
Sampling Methods
Sample Handling and Custody
Analytical Methods
Quality Control
Instrument/Equipment Testing, Inspection, and Maintenance
Instrument/Equipment Calibration and Frequency
Inspection/Acceptance of Supplies and Consumables
Non-direct Measurements
Data Management
3.3.1 Bl- Sampling Process Design (Experimental Design)
Describe the experimental data generation or data collection design for the project,
including as appropriate:
the types and numbers of samples required,
the design of the sampling network,
the sampling locations and frequencies,
sample matrices,
measurement parameters of interest, and
the rationale for the design.
EPA QA/R-5
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3.3.2 B2 - Sampling Methods
Describe the procedures for collecting samples and identity the sampling methods and
equipment, including any implementation requirements, sample preservation requirements,
decontamination procedures, and materials needed for projects involving physical sampling.
Where appropriate, identify sampling methods by number, date, and regulatory citation. If a
method allows the user to select from various options, then the method citations should state
exactly which options are being selected. Describe specific performance requirements for the
method. For each sampling method, identify any support facilities needed. The discussion should
also address what to do when a failure in the sampling or measurement system occurs, who is
responsible for corrective action, and how the effectiveness of the corrective action shall be
determined and documented.
Describe the process for the preparation and decontamination of sampling equipment,
including the disposal of decontamination by-products; the selection and preparation of sample
containers, sample volumes, and preservation methods; and maximum holding times to sample
extraction and/or analysis.
3.3.3 B3 - Sample Handling and Custody
Describe the requirements for sample handling and custody in the field, laboratory, and
transport, taking into account the nature of the samples, the maximum allowable sample holding
times before extraction or analysis, and available shipping options and schedules for projects
involving physical sampling. Sample handling includes packaging, shipment from the site, and
storage at the laboratory. Examples of sample labels, custody forms, and sample custody logs
should be included.
3.3.4 B4 - Analytical Methods
Identify the analytical methods and equipment required, including sub-sampling or
extraction methods, laboratory decontamination procedures and materials (such as hi the case of
hazardous or radioactive samples), waste disposal requirements (if any), and any specific
performance requirements for the method. Where appropriate, analytical methods may be
identified by number, date, and regulatory citation. Address what to do when a failure in the
analytical system occurs, who is responsible for corrective action, and how the effectiveness of the
corrective action shall be determined and documented. Specify the laboratory turnaround time
needed, if important to the project schedule.
List any method performance standards. If a method allows the user to select from
various options, then the method citations should state exactly which options are being selected.
For non-standard method applications, such as for unusual sample matrices and situations,
appropriate method performance study information is needed to confirm the performance of the
Final
EPA Q A/R-5 17 March 2001
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method for the particular matrix. If previous performance studies are not available, they must be
developed during the project and included as part of the project results.
3.3.5 B5 - Quality Control
Identify QC activities needed for each sampling, analysis, or measurement technique. For
each required QC activity, list the associated method or procedure, acceptance criteria, and
corrective action. Because standard methods are often vague or incomplete in specifying QC
requirements, simply relying on the cited method to provide this information is usually insufficient.
QC activities for the field and the laboratory include, but are not limited to, the use of blanks,
duplicates, matrix spikes, laboratory control samples, surrogates, or second column confirmation.
State the frequency of analysis for each type of QC activity, and the spike compounds sources and
levels. State or reference the required control limits for each QC activity and corrective action
required when control limits are exceeded and how the effectiveness of the corrective action shall
be determined and documented.
Describe or reference the procedures to be used to calculate applicable statistics (e.g.,
precision and bias). Copies of the formulas are acceptable as long as the accompanying narrative
or explanation specifies clearly how the calculations will address potentially difficult situations
such as missing data values, "less than" or "greater than" values, and other common data
qualifiers.
3.3.6 B6 - Instrument/Equipment Testing, Inspection, and Maintenance
Describe how inspections and acceptance testing of instruments, equipment, and their
components affecting quality will be performed and documented to assure their intended use as
specified. Identify and discuss the procedure by which final acceptance will be performed by
independent personnel (e.g., personnel other than those performing the work) and/or by the EPA
project manager. Describe how deficiencies are to be resolved, when re-inspection will be
performed, and how the effectiveness of the corrective action shall be determined and
documented.
Describe or reference how periodic preventive and corrective maintenance of
measurement or test equipment or other systems and their components affecting quality shall be
performed to ensure availability and satisfactory performance of the systems. Identify the
equipment and/or systems requiring periodic maintenance. Discuss how the availability of critical
spare parts, identified in the operating guidance and/or design specifications of the systems, will
be assured and maintained.
3.3.7 B7 - Instrument/Equipment Calibration and Frequency
Identify all tools, gauges, instruments, and other sampling, measuring, and test equipment
used for data generation or collection activities affecting quality that must be controlled and, at
Final
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specified periods, calibrated to maintain performance within specified limits. Describe or
reference how calibration will be conducted using certified equipment and/or standards with
known valid relationships to nationally recognized performance standards. If no such nationally
recognized standards exist, document the basis for the calibration. Identify the certified
equipment and/or standards used for calibration. Indicate how records of calibration shall be
maintained and be traceable to the instrument.
3.3.8 B8 - Inspection/Acceptance of Supplies and Consumables
Describe how and by whom supplies and consumables (e.g., standard materials and
solutions, sample bottles, calibration gases, reagents, hoses, deionized water, potable water,
electronic data storage media) shall be inspected and accepted for use in the project. State
acceptance criteria for such supplies and consumables.
3.3.9 B9 - Non-direct Measurements
Identity any types of data needed for project implementation or decision making that are
obtained from non-measurement sources such as computer data bases, programs, literature files,
and historical data bases. Describe the intended use of the data. Define the acceptance criteria
for the use of such data in the project and specify any limitations on the use of the data.
3.3.10 BIO - Data Management
Describe the project data management process, tracing the path of the data from their
generation to their final use or storage (e.g., the field, the office, the laboratory). Describe or
reference the standard record-keeping procedures, document control system, and the approach
used for data storage and retrieval on electronic media. Discuss the control mechanism for
detecting and correcting errors and for preventing loss of data during data reduction, data
reporting, and data entry to forms, reports, and databases. Provide examples of any forms or
checklists to be used.
Identify and describe all data handling equipment and procedures to process, compile, and
analyze the data. This includes procedures for addressing data generated as part of the project as
well as data from other sources. Include any required computer hardware and software and
address any specific performance requirements for the hardware/software configuration used.
Describe the procedures that will be followed to demonstrate acceptability of the
hardware/software configuration required. Describe the process for assuring that applicable
information resource management requirements are satisfied.
Describe the process for assuring that applicable Agency information resource
management requirements (EPA Directive 2100) are satisfied (EPA QA Project Plans only). If
other Agency data management requirements are applicable, such as the Chemical Abstract
Service Registry Number Data Standard (EPA Order 2180.1), Data Standards for the Electronic
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Transmission of Laboratory Measurement Results (EPA Order 2180.2), the Minimum Set of Data
Elements for Ground-Water Quality (EPA Order 7500.1 A), ornew data standards as they are
issued by EPA, discuss how these requirements are addressed.
3.4 GROUP C: ASSESSMENT AND OVERSIGHT
The elements in this group (Table 3) address the activities for assessing the effectiveness
of project implementation and associated QA and QC activities. The purpose of assessment is to
ensure that the QA Project Plan is implemented as prescribed.
Table 3. Group C: Assessment and
Oversight Elements
Cl
C2
Assessments and Response
Actions
Reports to Management
3.4.1 Cl - Assessments and Response Actions
Describe each assessment to be used in the project including the frequency and type.
Assessments include, but are not limited to, surveillance, management systems reviews, readiness
reviews, technical systems audits, performance evaluations, audits of data quality, and data quality
assessments. Discuss the information expected and the success criteria (i.e., goals, performance
objectives, acceptance criteria specifications, etc.) for each assessment proposed. List the
approximate schedule of assessment activities. For any planned self-assessments (utilizing
personnel from within the project groups), identify potential participants and then- exact
relationship within the project organization. For independent assessments, identify the
organization and person(s) that shall perform the assessments if this information is available.
Describe how and to whom the results of each assessment shall be reported.
Define the scope of authority of the assessors, including stop work orders, and when
assessors are authorized to act.
Discuss how response actions to assessment findings, including corrective actions for
deficiencies and other non-conforming conditions, are to be addressed and by whom. Include
details on how the corrective actions will be verified and documented.
3.4.2 C2 - Reports to Management
Identify the frequency and distribution of reports issued to inform management (EPA or
otherwise) of the project status; for examples, reports on the results of performance evaluations
and system audits; results of periodic data quality assessments; and significant quality assurance
EPA QA/R-5
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Final
March 2001
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problems and recommended solutions. Identify the preparer and the recipients of the reports, and
any specific actions recipients are expected to take as a result of the reports*!
3.5 GROUP D: DATA VALIDATION AND USABILITY
The elements in this group (Table 4) address the QA activities that occur after the data
collection phase of the project is completed. Implementation of these elements determines
whether or not the data conform to the specified criteria, thus satisfying the project objectives.
Table 4. Group D: Data Validation
and Usability Elements
Dl
D2
D3
Data Review, Verification, and Validation
Verification and Validation Methods
Reconciliation with User Requirements
3.5.1 Dl - Data Review, Verification, and Validation
State the criteria used to review and validate that is, accept, reject, or qualify data, in
an objective and consistent manner.
3.5.2 D2 - Verification and Validation Methods
Describe the process to be used for verifying and validating data, including the chain-of-
custody for data throughout the life of the project or task. Discuss how issues shall be resolved
and the authorities for resolving such issues. Describe how the results are conveyed to data users.
Precisely define and interpret how validation issues differ from verification issues for this project.
Provide examples of any forms or checklists to be used. Identify any project-specific calculations
required.
3.5.3 D3 - Reconciliation with User Requirements
Describe how the results obtained from the project or task will be reconciled with the
requirements defined by the data user or decision maker. Outline the proposed methods to
analyze the data and determine possible anomalies or departures from assumptions established in
the planning phase of data collection. Describe how reconciliation with user requirements will be
documented, issues will be resolved, and how limitations on the use of the data will be reported to
decision makers.
EPA QA/R-5
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EPAQA/R-5 22 March 2001
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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."
ANS1/ASQC E4-1994, Specifications and Guidelines for Quality Systems for Environmental
Data Collection and Environmental Technology Programs, American National Standard,
January 1995.
EPA Directive 2100 (1998), Information Resources Management Policy Manual, U.S.
Environmental Protection Agency, Washington, DC.
EPA Order 2180.1 (June 1987), Chemical Abstract Service Registry Number Data Standard,
U.S. Environmental Protection Agency, Washington, DC.
EPA Order 2180.2 (December 1988), Data Standards for the Electronic Transmission of
Laboratory Measurement Results, U.S. Environmental Protection Agency, Washington,
DC.
EPA Order 5360 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
Agency-wide Quality System, U.S. Environmental Protection Agency, Washington, DC.
EPA Order 7500.1A (October 1992), Minimum Set of Data Elements for Ground-Water Quality,
U.S. Environmental Protection Agency, Washington, DC.
U.S. Environmental Protection Agency, 2001. EPA Requirements for Quality Management
Plans (QA/R-2), EPA/240/B-01/002, Office of Environmental Information.
U.S. Environmental Protection Agency, 2000a. Guidance for Data Quality Assessment:
Practical Methods for Data Analysis (QA/G-9), EPA/600/R-96/084, Office of
Environmental Information.
Final
EPAQA/R-5 23 March 2001
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U.S. Environmental Protection Agency, 2000b. Guidance for the Data Quality Objectives
Process (QA/G-4), EPA/600/R-96/055, Office of Environmental Information.
U.S. Environmental Protection Agency, 1998. Guidance for Quality Assurance Project Plans
(QA/G-5), EPA/600/R-98/018, Office of Research and Development.
U.S. Environmental Protection Agency, 1995. Guidance for the Preparation of Standard
Operating Procedures (SOPs)for Quality-Related Documents (QA/G-6), EPA/600/R-
96/027, Office of Research and Development.
U.S. Environmental Protection Agency, 1980. Interim Guide lines and Specifications for
Preparing Quality Assurance Project Plans, QAMS-005/80, Office of Research and
Development.
Final
EPAQA/R-5 24 March 2001
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APPENDIX A
CROSSWALKS AMONG QUALITY ASSURANCE DOCUMENTS
A.1 BACKGROUND
This appendix contains crosswalks between this document and other QA planning
documents. The first crosswalk compares this requirements document with its predecessor
document, QAMS 005/80, Interim Guidelines and Specifications for Preparing Quality
Assurance Project Plans (EPA 1980). The second crosswalk compares the elements of the QA
Project Plan defined in this document with the steps defined in Guidance for the Data Quality
Objectives Process (QA/G-4) (EPA 2000b), the Agency's preferred systematic planning process,
for environmental decision making. This crosswalk is provided to assist the reader in determining
how the outputs from the DQO Process can be integrated into a QA Project Plan.
A.2 CROSSWALK BETWEEN EPA QA/R-5 AND QAMS-005/80
QAMS-005/80 ELEMENTS
1.0
2.0
3.0
4.0
5.0
6.0
7.0
8.0
Title Page with Provision for
Approval Signatures
Table of Contents
Project Description
Project Organization and
Responsibility
QA Objectives for Measurement
Data (PARCC)
Sampling Procedures
Sample Custody
Calibration Procedures and
Frequency
QA/R-5 ELEMENTS
Al
A2
A5
A6
A3
A4
A8
A9
A7
Bl
B2
B3
B7
Title and Approval Sheet
Table of Contents
Problem Definition/Background
Project/Task Description
Distribution List
Project/Task Organization
Special Training/Certification
Documents and Records
Quality Objectives and Criteria
Sampling Process Design
Sampling Methods
Sample Handling and Custody
Instrument/Equipment Calibration and
Frequency
EPA QA/R-5
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Final
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QAMS-005/80 ELEMENTS
9.0
10.0
11.0
12.0
13:0
14.0
15.0
16.0
Analytical Procedures
Data Reduction, Validation, and
Reporting
Internal Quality Control Checks
and Frequency
Performance and Systems
Preventive Maintenance
Specific Routine Procedures Mea-
surement Parameters Involved
Corrective Action
QA Reports to Management
QA/R-5 ELEMENTS
B4
Dl
D2
B9
BIO
B5
Cl
-B6
D3
Cl
C2
Analytical Methods
Data Review, Verification, and
Validation
Verification and Validation Methods
Non-direct Measurements
Data Management
Quality Control
Assessments and Response Actions
Instrument/Equipment Testing,
Inspection, and Maintenance
Reconciliation with User Requirements
Assessments and Response Actions
Reports to Management
EPA QA/R-5
A-2
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Final
March 2001
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A.3 CROSSWALK BETWEEN THE DQO PROCESS AND THE QA PROJECT PLAN
Elements
Requirements
DQO Overlap
PROJECT MANAGEMENT
Al Title and Approval Sheet
A2 Table of Contents
A3 Distribution List
A4 Project/Task
Organization
A5 Problem Definition/
Background
A6 Project/Task Description
A7 Quality Objectives and
Criteria
A8 Special Training/
Certification
A9 Documents and Records
Title and approval sheet.
Document control format.
Distribution list for the QA Project Plan
revisions and final guidance.
Identify individuals or organizations
participating in the project and discuss their
roles, responsibilities and organization.
1) State the specific problem to be solved or
the decision to be made.
2) Identify the decision maker and the principal
customer for the results.
1) Hypothesis test, 2) expected measurements,
3) ARARs or other appropriate standards, 4)
assessment tools (technical audits), 5) work
schedule and required reports.
Decision(s), population parameter of interest,
action level, summary statistics and acceptable
limits on decision errors. Also, scope of the
project (domain or geographical locale).
Identify special training that personnel will
need.
Itemize the information and records that must
be included in a data report package, including
report format and requirements for storage,
etc.
N/A
N/A
Step 1: State the Problem
Step 1 : State the Problem
Step 1 : State the Problem
Step 2: Identify the Decision
Stepl: State the Problem
Step 2: Identify the Decision
Step 3 : Identify the Inputs to the Decision
Step 6: Specify Limits on Decision Errors
Step 4: Define the Boundaries
Step 5: Develop a Decision Rule
Step 6: Specify Limits on Decision Errors
N/A
Step 3 : Identify the Inputs to the Decision
Step 7: Optimize the Design for Obtaining Data
EPA QA/R-5
A-3
Final
March 2001
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Elements
Requirements
DQO Overlap
DATA GENERATION AND ACQUISITION
B 1 Sampling Process Design
(Experimental Design)
B2 Sampling Methods
B3 Sample Handling and
Custody
B4 Analytical Methods
B5 Quality Control
B6 Instrument/Equipment
Testing, Inspection, and
Maintenance
B7 Instrument/Equipment
Calibration and
Frequency
B8 Inspection/Acceptance of
Supplies and
Consumables
Outline the experimental design, including
sampling design and rationale, sampling
frequencies, matrices, and measurement
parameter of interest.
Sample collection method and approach.
Describe the provisions for sample labeling,
shipment, chain-of-custody forms, procedures
for transferring and maintaining custody of
samples.
Identify analytical method(s) and equipment
for the study, including method performance
requirements.
Describe quality control procedures that
should be associated with each sampling and
measurement technique. List required checks
and corrective action procedures.
Discuss how inspection and acceptance testing,
including the use of QC samples, must be
performed to ensure their intended use as
specified by the design.
Identify tools, gauges and instruments, and
other sampling or measurement devices that
need calibration. Describe how the calibration
should be done.
Define how and by whom the sampling
supplies and other consumables will be
accepted for use in the project.
Step 5:
Step 7:
Step 7:
Develop a Decision Rule
Optimize the Design for Obtaining Data
Optimize the Design for Obtaining Data
N/A
Step 3:
Step 7:
StepS:
Step 3:
Step 3:
Identify the Inputs to the Decision
Optimize the Design for Obtaining Data
Identify the Inputs to the Decision
Identify the Inputs to the Decision
Identify the Inputs to the Decision
N/A
EPA QA/R-5
A-4
Final
March 2001
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Elements
B9 Non-direct
Measurements
BIO Data Management
Requirements
Define the criteria for the use of non-
measurement data, such as data that come
from databases or literature.
Outline the data management scheme including
the path and storage of the data and the data
record-keeping system. Identify all data
handling equipment and procedures that will be
used to process, compile, and analyze the data.
DQO Overlap
Step 1: State the Problem
Step 7: Optimize the Design for Obtaining Data
Step 3: Identify the Inputs to the Decision
Step 7: Optimize the Design for Obtaining Data
ASSESSMENT AND OVERSIGHT '
Cl Assessments and
Response Actions
C2 Reports to Management
Describe the assessment activities needed for
this project.
Identify the frequency, content, and
distribution of reports issued to keep
management informed.
Step 7: Optimize the Design for Obtaining Data
N/A
DATA VALIDATION AND USABILITY
Dl Data Review,
Verification, and
Validation
D2 Verification and
Validation Methods
D3 Reconciliation With User
Requirements
State the criteria used to accept or reject the
data based on quality.
Describe the process to be used for verifying
and validating data, including the chain-of-
custody for data throughout the lifetime of the
project.
Describe how results will be evaluated to
determine if performance criteria have been
satisfied.
Step 7: Optimize the Design for Obtaining Data
Step 3: Identify the Inputs to the Decision
Step 7: Optimize the Design for Obtaining Data
EPA QA/R-5
A-5
Final
March 2001
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(This page is intentionally blank.)
Final
EPAQA/R-5 A-6 March 2001
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QAPP CLASSROOM PRACTICAL EXERCISE #1
In small groups, we will review a "Good Example" of a "Bad Example" of a Quality
Assurance Project Plan submitted by the Commonwealth of East Carolina's Water
Commission (ECWC), by it's Marine and Estuarine Division. The QAPP is being submitted
as part of a Grant Application Package by the ECWC to seek $350,000.00 to determine the
cause of recent Fish and Shellfish Kills in Cedar Bay. Watch the video tape for additional
information, keeping in mind two things:
1. What is the purpose of the proposed project?
2. What is the primary motive behind the Governor's involvement in this project?
Spending a limited amount of time, as defined by the instructor, review the sections
identified by the instructor using EPA QA/R-5 as the review criteria, list the things in those
sections that are incorrect.
167
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NOTES
168
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QUALITY ASSURANCE PROJECT PLAN
FOR
DETERMINING ENVIRONMENTALLY RELATED CAUSES OF
FISH KILLS IN CEDAR BAY FY 1994
PROJECT OFFICER: Rebecca Quince
QUALITY ASSURANCE OFFICER: Bob Gilmore
PROJECT DIRECTOR: Zack Dempsey
169
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NOTES
170
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TABLE OF CONTENTS
Revision 0, October 15, 1996
Page
I Distribution List 1
n Project/Task Organization 2
HI Problem Definition/Background 2
IV Project Task Description 2
V Data Quality Objectives for Measurement Data 4
VI Special Training Requirements/Certification 4
VII Documentation and Records 4
Vin Sampling Process Design (Experimental Design) 6
IX Sampling Methods Requirements 6
X Sample Handling and Custody Requirements ' 9
XI Analytical Methods Requirements 9
XII Quality Control Requirements 9
XIII Instrument/Equipment Testing, Inspecting, and
Maintenance Requirements 9
XIV Instrument Calibration and Frequency 12
XV Inspection/Acceptance Requirements for Supplies
and Consumables 12
XVI Data Acquisition Requirements 12
XVn Data Management 12
XVIII Assessments and Response Actions 12
XIX Reports to Management 13
XX Data Review, Validation and Verification Requirements 13
LIST OF TABLES
Table 1: Quality Assurance Requirements 5
Table 2: Monitoring Parameters 8
Table 3: Analytical Methods 10
Table 4: QC Checks for Precision/Accuracy 11
LIST OF FIGURES
Figure 1: Responsibilities of Personnel 3
Figure 2: Data Collection Sites on Cedar Bay 7
APPENDICES
Appendix A: Receipt Document For QAPP Distribution A-l
Appendix B: Sample Tracking Sheet B-l
Appendix C: Sample Tag C-l
171
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Section No. I
Revision No. 0
Date Oct. 15. 1996
Page 1 of 13
I Distribution List
Following individuals will receive copies of approved QAPP.
Project Personnel:
Zack Dempsey
Bob Gilmore
Rebecca Quince
Joan Breedon
Paul Cronin
Robert Mendez
Mark Preston
Diane Jenkins
U.S. EPA Region 6 Personnel:
Alva Smith, 6EN-XQ
Charles Ritchey, 6EN-XQ
Russell Bowen, 6WQ-AG
Petra Sanchez, 6PD-L
Linda Raye Chapman, 6WQ-EW
Karen Alverez, 6PD-S
Steffanie Barnett, 6WQ-EM
Pam Mintz, 6WQ-AG
Other Personnel/Organizations:
Governors Office
Chairman, State Water Management Board
President, State Shellfishermans Association
President, Cedar Bay Homebuilders Association
President, Cedar Bay Chamber of Commerce
President, Cedar Bay Farmers Cooperative
President, Cedar Bay Realators Association
Director AAA-Ace Environmental Sampling and Analytical
Laboratory (3 Copies)
Each copy of the QAPP will be serial numbered, and a receipt will be signed and returned to
the QA Officer. Example of the receipt document is Appendix A of this document. Recipients
are responsible for assuring they have a current and correct copy of the applicable QAPP.
172
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Section No. II - IV
Revision No. 0
Date Oct. 15. 1996
H Project/Task Organization Page_J_ of 13
The individuals responsible for the major aspects of the project are provided in Figure 1.
HI Problem Definition/Background
This project was developed by the State Water Management Board, in conjunction with the
Cedar Bay Technical Institute, to determine the environmental causes of recent fish and shellfish
kills in the area. There is only minimal background studies and information known to exist for
environmental concerns in Cedar Bay, primarily a DDT Study was performed in 1977, by the
State Agriculture Department, funded by the U.S.D.A., that indicated a level of DDT present
that was far below any level of concern. A limited study was performed in December of 1993,
for Total Suspended Solids (TSS), by the AAA-Ace Environmental Sampling and Analytical
Laboratory, funded by the Cedar Bay Homebuilders Association. Results are not considered
valid due to Laboratory not being able to show traceability of results to sampling events or
locations.
IV Project Task Description
This project is to define the nature and extent of contamination or pollution that may be present
in Cedar Bay by:
* The collection and analysis of samples to determine water quality;
* Define the types of chemicals and fertilizers being used in agricultural land management
processes;
* Determine presence of contamination or pollution caused by construction;
* Collect biological specimens for fish and shellfish tissue samples.
All project records and QA/QC data will be retained for at least 5 years after completion of the
project.
All sample collection will be completed within 45 days of the start of the project, and all
analytical work and data validation completed within 60 days of the start of the project. Project
will start within 30 days of receipt of funding.
173
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Section No. H.
FIGURE 1
RESPONSIBILITIES OF PERSONNEL
Revision No. Q_
Date Oct. 15. 1996
Page 3 of 13
PROJECT DIRECTOR
Zack Dempsey
QA OFFICER
Bob Gilmore
PROJECT OFFICER
Rebecca Quince
Water Mgmt. Board
LABORATORY ANALYSIS
Joan Breedon
DATA PROCESSING
Bob Gilmore
QC
Robert Mendez
FIELD OPERATIONS
Paul Cronin
QC
Mark Preston
QC
Diane Jenkins
Water Quality Lab
Cedar Bay Technical Institute
42 Catskill Lane
Benton, EC 79797
Agriculture Engineering Department
Cedar Bay Technical Institute
249 Plantation Drive
Benton, EC 79797
174
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Section No. V-VH
Revision No. 0
Date Oct. 15. 1996
Page 4 of 13
V Data Quality Objectives for Measurement Data
The Data Quality Objectives Process is not required for this project, as the Data must be of the
highest quality possible from the analytical equipment available at the laboratories performing
the analytical work. To that end the data quality requirements are specified in Table 1, and
were based on the best available advice of several experienced staff members of the Water
Resources Board.
VI Special Training Requirements/Certification
Sampling Personnel
Since much of the sample collection will be from boats all personnel that are responsible for
actual boat operation must successfully complete a U.S.C.G. Safe Boating course. All sample
collectors will be briefed on the correct methods to take samples, prior to start of sample
collection operations. At least one person in each boat will possess a current Red Cross
Lifesaving Certification. All personnel working in and around the boats shall have successfully
passed Red Cross First Aid and CPR Training courses within the past 3 years.
Analytical Personnel
All analytical chemists will have, at a minimum, a B.S. in Chemistry, and at least two years
experience in Analytical Chemistry.
All biologists will have, at a minimum, a B.S. in Marine Biology or Microbiology, as
applicable, and at least two years experience in their field.
Other Personnel
All other personnel will be qualified for their positions.
VII Documentation and Records
All field samplers will maintain an accurate field log that describes as specifically as possible
the location where the sample was collected, its appearance, its sample tag number, and any
information that would be beneficial to the analyst. If a sampling plan cannot be followed
exactly the sampler is to notify the Project Officer, who will issue verbal instructions to the
sampler.
175
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Section No. V
TABLE 1
Revision No. 0
Date Oct. 15. 1996
Page 5 of 13
QUALITY ASSURANCE REQUIREMENTS
Parameter Sample Detection Quantitation Estimated Estimated
Matrix Limit Limit Accuracy Precision
TSS
All 0.01 mg/1
It relative ±1 mg/1
error
COD
All
5 mg/1
15 ng/1 it relative ±1 mg/1
error
BOD
All
5 mg/1
15 mg/1 1% relative +1 mg/1
error
All 0.02 mg/1
1 mg/1 99-1071 +0.01 mg/1
recovery
All
0.2 mg/1
l mg/1 96-100* ±0.01 mg/1
recovery
T-P
All
0.1 mg/1
5 mg/1 86-96* ±0.01 mg/1
recovery
TKN
All
All
0.1 mg/1
0.02 mg/1
5 mg/1 bias %-25% ±0.01 mg/1
1 mg/1
Pesticides All 0.012 mg/1 o.02 mg/1
89-96% ±0.01 mg/1
recovery
75-150* ±0.2 ug/1
recovery
176
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Section No. VII - IX
Revision No. 0
Date Oct. 15. 1996
Page 6 of 13
Records of samples sent for analysis will be maintained by the samplers and receipt will be
verified with the analytical laboratory.
Laboratories will provide all analytical data in written format. All individual data sheets will
be dated and signed/initialed by the analyst, the data validator, and the appropriate supervisor.
Data validation will be performed on all data, and both validated and raw data will be provided
to the Project Officer for review, evaluation and approval.
All QA/QC data will be filed.
Sampling Process Design (Experimental Design)
All sampling procedures and monitoring equipment has been tested to ensure the collection of
valid data.
The frequency of monitoring parameters in this project is uniform. Due to the nature and extent
of the study, collection activities will take place only once.
Grab samples for surface runoff will be collected with a bucket and immediately stored in
water-tight containers for shipping. Two types of biological samples will be collected and
compared for lab analysis. The first set will come from the dead fish/shellfish at the kill sites;
the second set will be living organisms accumulated with netting from Cedar Bay. The tissues
from each set will be tested and analyzed for pesticides and chemicals. The composite water
samples will be collected at intervals using a submersible pump. The results from the 3-foot
interval and the 6-foot interval will then be mixed together in one container. All air samples
will be analyzed for temperature. Also, engine emission pollutants from hydrocarbons will be
measured using an organic vapor analyzer (OVA). As water samples are collected they will be
stored on ice until delivery to a laboratory for analysis.
IX Sampling Methods Requirements
Sampling locations were chosen to best represent the area of the largest number of fish/shellfish
kills. Figure 2 shows the locations of the data collection sites, and Table 2 lists the sample
types, matrix, monitoring parameters, and frequency of collection at each site.
Because of the nature and extent of the project, only one sampling event per site and sample type
will occur during the confines of the study.
Instantaneous grab samples for surface runoff will be collected at stations CB1-CB3, and will
be representative of contaminants from nearby farm lands. At stations CB4-CB6, composite
177
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Section No. IX
Revision No. 0
FIGURE 2
DATA COLLECTION SITES ON CEDAR BAY
Date Oct. 15. 1996
Page 7 of 13
178
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TABLE 2
Section No. IX
Revision No. 0
Date Oct. 15. 1996
Page 8 of 13
MONITORING PARAMETERS
SITE TYPE OF SAMPLE MATRIX PARAMETERS FREQUENCY
CB1-CB3
Grab
Surface TSS
Runoff Nitrate
Ammonia
TKN
Total Nitrogen
Ortho -P
Total -P
Filterable Total -P
Ch. Oxygen Demand
Bio. Oxygen Demand
Pesticides
1 Event
CB4-CB6
Composite
Cedar Bay
Water Sample
-3ft interval
-6ft interval
CB1-CB6
FD1-FD2
P1-P3
A1-A3
A4-A6
Grab
Grab
Air
Biological
(Fish)
Controlled Rainfall
Grab
Grab
Air
Air
TSS
Nitrate
Ammonia
TKN
Total Nitrogen
Ortho -P
Total -P
Filterable Total -P
Ch. oxygen Demand
Bio. Oxygen Demand
Pesticides
Temperature
Pesticides
Quantity
Intensity
Temperature
Temperature
Engine Emission
1 Event
1 Event
1 Event
10 min.
10 min.
1 Event
1 Event
179
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Section No. IX - XII
Revision No. 0
Date Or.t 15. 1996
Page 9 of 13
water samples from Cedar Bay will be collected at various depths to determine contaminant
characteristics at various depths. Air samples will be taken at stations CB1-CB6. Air
monitoring stations will be located near the main highway and in areas where extensive boating
activity occurs to assess possible pollutants from exhaust emissions.
Random temperature readings from air samples will be taken and recorded in the field log
books. Grab samples for biological testing will be collected at stations FD1-FD2 to determine
if pesticides are present in tissue samples. Stations P1-P3 will collect controlled rainfall samples
to determine quantity and intensity.
X Sample Handling and Custody Requirements
Samples will be delivered to the designated laboratory within 24 hours of each sampling event
and stored in a freezer onsite at 10 degrees Celsius. The sampling tracking sheet (example at
Appendix B) included with the samples must be checked upon arrival to ensure that all required
information is included, such as sample date, location sampled, type of sample, number of
samples, and the name of the person who sent the samples. Samples will not be discarded until
all analyses have been completed and confirmed.
XI Analytical Methods Requirements
Table 3 provides references for each analytical method that will be used in the project.
XII Quality Control Requirements
Table 4 contains precision/accuracy protocol for QC checks. A comprehensive plan for the field
has been prepared and is available from the QA officer.
XIII Instrument/Equipment Testing, Inspecting, and
Maintenance Requirements
All field and analytical instruments and equipment will be inspected and tested daily, prior to
operation. Any instruments and equipment not passing the daily inspection and test will not be
used unless there are no alternates available. Operation and preventative maintenance for field
equipment can be found in the manufacturer's instructions of each piece of equipment.
Laboratory preventative maintenance procedures are provided in the laboratory QA Project Plan.
180
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TABLE 3
ANALYTICAL METHODS
Section No. XI
Revision No. Q_
Date Oct. 15. 1996
Page 10 of 13
Parameter
Number of
Samples
Sample
Matrix
Method
Reference
TSS
COD
BOD
NHj-N
NO,-N
T-P
TKN
P04
Pesticides
Temperature
Conductivity.
AH
All
All
All
All
All
All
All
All
All
All
Water
Water
Water
Water
Water
Water
Water
Water
Water
Fish tissue
Water
Water
209C'
508C*
507'
417G'
006302
006252
006692
424G1
8080J
212'
205'
1 Standard Methods for Examination of Water and Wastevater, 16th
ed., 1985, American Public Health Association, Washington, D.C.
] Manual for Chemical Analysis of Water and Wastes, 1974, U.S.
Environmental Protection Agency, Waohington, D.C.
r SW 846
181
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Section No. XH
TABLE 4
Revision No. 0
Date Oct. 15. 1996
Page 11 of 13
QC CHECKS FOR PRECISION AND ACCURACY
Parameter
Sample
Precision/Accuracy
Protocol
TSS
All
1 duplicate/20 samples
1 standard/day
COD
All
1 duplicate/5 samples
6 standards/40 samples
BOD
All
1 duplicate/5 samples
6 standards/40 samples
All
5 standards/30 samples
1 NBS standard/day
NO,-N
All
4 standards/30 samples
1 MBS standard/day
T-P
All
5 standards/30 samples
1 NBS standard/day
TKN
All
4 standards/30 samples
1 NBS standard/day
P04
All
6 standards/30 samples
1 NBS standard/day
Pesticides
All
3 standards/30 samples
1 NBS standard/day
182
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Section Mn YTV - XVm
Revision No. Q
XIV Instrument Calibration and Frequency Date.Bet 15, 1996
Page 12 of 13
All thermometers are precalibrated by the National Institute of Science and Technology. The
organic vapor analyzer will be calibrated according to the manufacturer's instructions prior to
each sampling event.
Laboratory calibration procedures are defined in the laboratory QA Project Plan.
XV Inspection/Acceptance Requirements for Supplies
and Consumables
All supplies and consumables, upon receipt, will be verified with shipping/receiving documents,
and purchase order to verify quantity ordered equals quantity received. Incorrect quantity
shipments will be reported to purchasing agent for resolution with the supplier. Incorrect items
will be evaluated by receiving clerk for suitability of use.
XVI Data Acquisition Requirements (Non-direct Measurements)
Existing data from the limited study performed for Total Suspended Solids (TSS), by the AAA-
Ace Environmental Sampling and Analytical Laboratory, funded by the Cedar Bay Homebuilders
Association has been evaluated and results are not considered valid due to Laboratory not being
able to show traceability of results to sampling events or locations. If reconstruction of samplers
logs is accomplished that provides traceability of sample location to analytical results, those
individual data are considered acceptable for use as background material.
XVII Data Management
The data management system used by the laboratory performing the analytical work shall be
described in the laboratory QA Project Plan.
XVm Assessments and Response Actions
Performance and systems audits will occur in the field and the laboratory. Field audits will
consist of the staff overseeing all sampling procedures. Laboratory audits will include double
blind performance evaluation samples to assess the efficiency of laboratory staff. The results
will be given to Rebecca Quince for review.
183
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Section No. XIX - XX
Revision No. 0
Date Drt. 15. 1996
Page 13 of 13
XIX Reports to Management
Interim QA reports will be issued bi-weekly during the course of the study. A final report will
be issued at the termination of the project, and is the responsibility of the Project Director.
XX Data Review, Validation, and Verification Requirements
All data reduction procedures will follow the method specifications for performing calculations,
found in Bloch et al (1986). All data will be reviewed 100%. Data validation processes will
include verification mat all QA criteria have been met. Data reporting procedures will ensure
that all data outlined have been evaluated to determine if data quality is adequate.
REFERENCES
Bloch, S. Conducting Field Research in Agricultural Hydrology. Agricultural Handbook No.
95. Washington, D.C.: U.S. Department of Agriculture, 1986.
184
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QAPP CLASSROOM PRACTICAL EXERCISE #2
In our same small groups, we will now revise the "Bad Example" of a Quality Assurance
Project Plan into a "Better Example" of a QAPP.
Work in your group on the sections assigned by the instructor, using EPA QA/R-5 as the criteria
document for the revision.
185
-------
NOTES
186
-------
Original Cover Page (Compressed):
QUALITY ASSURANCE PROJECT PLAN
FOR
DETERMINING ENVIRONMENTALLY RELATED CAUSES OF
FISH KILLS IN CEDAR BAY FY 1994
PROJECT OFFICER: Rebecca Quince
QUALITY ASSURANCE OFFICER: Bob Gilmore
PROJECT DIRECTOR: Zack Dempsey
Comments: Title Page/Element Al: Missing required signatures of Project Personnel, missing
names and signatures of EPA personnel. Name of organization implementing project not
provided.
Requirement; Al
Include:
Title and Approval Sheet
Title of the plan
Name of the organization(s) implementing the project
Names, titles, signatures of appropriate approving officials and
approval dates for:
Organization's Project Manager (Required)
Organization's Quality Assurance Manager (Required)
Project Subordinate Supervisors Concurrence (Optional)
Region 6 EPA Project Manager (Required)
Region 6 EPA Approving Official (Required)*
Others, as needed (e.g., State, other Federal Agency)
Title and Region 6 QTRAK number of the approved Quality
Management Plan applicable to submitted QAPP
Submission of at least two original approval pages is recommended.
"EPA Approving Official'' is the Region 6 Program Office Manager or staff person designated and authorized by Certification of the Region 6 QA
Officer to approve QAPPs. If the EPA Project Manager/Officer is unable to determine the approving official, contact the Office of Quality Assurance.
187
-------
(Revised Title Page)
QUALITY ASSURANCE PROJECT PLAN
FOR
DETERMINING ENVIRONMENTALLY RELATED
CAUSES OF
FISH KILLS IN CEDAR BAY FY 1994
SUBMITTED BY EAST CAROLINA
WATER COMMISSION
188
-------
(New Approval Page)
Quality Assurance Project Plan for Determining Environmentally Related Causes of Fish Kills
in Cedar Bay FY 1994
Plan is prepared by, and work to be implemented by, ,the East Carolina Water Commission,
under the East Carolina Water Commission Quality Management Plan for Marine and Estuarine
Environmental Monitoring and Remedial Action, EPA Region 6 QTRAK # Q-94-069.
Plan Prepared By:
Date:
Rebecca Quince, ECWC Project Officer
ECWC Concurrence:
. Date:
Joan Breedon, Laboratory Director
Date:
Bob Gilmore, Data Processing Chief
Date:.
Paul Cronin, Field Operations Chief
ECWC Approvals:
Date:_
Troy Achemann, Project QA Officer
Date:
Zack Dempsey, Project Director
EPA Approvals:
Rebecca Quince, Project Officer
Date:
Date:
Steffanie Barnett, Project Officer
Date:
Richard Hoppers, Chief, 6W-Q
189
-------
Original Table of Contents;
TABLE OF CONTENTS
Revision 0, October 15, 1996
Page
I Distribution List 1
n Project/Task Organization 2
IE Problem Definition/Background 2
IV Project Task Description 2
V Data Quality Objectives for Measurement Data 4
VI Special Training Requirements/Certification 4
VII Documentation and Records 4
VIE Sampling Process Design (Experimental Design) 6
IX Sampling Methods Requirements 6
X Sample Handling and Custody Requirements 9
XI Analytical Methods Requirements 9
Xn Quality Control Requirements 9
XIII Instrument/Equipment Testing, Inspecting, and
Maintenance Requirements 9
XTV Instrument Calibration and Frequency 12
XV Inspection/Acceptance Requirements for Supplies
and Consumables 12
XVI Data Acquisition Requirements 12
XVH Data Management 12
XVin Assessments and Response Actions 12
XK Reports to Management 13
XX Data Review, Validation and Verification Requirements 13
LIST OF TABLES
Table 1: Quality Assurance Requirements 5
Table 2: Monitoring Parameters 8
Table 3: Analytical Methods 10
Table 4: QC Checks for Precision/Accuracy 11
LIST OF FIGURES
Figure 1: Responsibilities of Personnel 3
Figure 2: Data Collection Sites on Cedar Bay 7
APPENDICES
Appendix A: Receipt Document For QAPP Distribution A-l
Appendix B: Sample Tracking Sheet B-l
Appendix C: Sample Tag C-l
Comments; Table of Contents/Element A2: Acceptable, recommend use of document
control format on this page to be consistent throughout the QAPP.
190
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Revised Table of Contents;
TABLE OF CONTENTS
Revision 0, October 15, 1996
Page Rev.
I Distribution List 1 0
n Project/Task Organization 2 0
ffl Problem Definition/Background 2 0
IV Project Task Description 2 0
V Data Quality Objectives for Measurement Data 4 0
VI Special Training Requirements/Certification 4 0
VII Documentation and Records 4 0
Vffl Sampling Process Design (Experimental Design) 6 0
IX Sampling Methods Requirements 6 0
X Sample Handling and Custody Requirements 9 0
XI Analytical Methods Requirements 9 0
XT! Quality Control Requirements 9 0
Xin Instrument/Equipment Testing, Inspecting, and
Maintenance Requirements 9 0
XTV Instrument Calibration and Frequency 12 0
XV Inspection/Acceptance Requirements for Supplies
and Consumables 12 0
XVI Data Acquisition Requirements 12 0
XVH Data Management 12 0
XVin Assessments and Response Actions 12 0
XIX Reports to Management 13 0
XX Data Review, Validation and Verification Requirements 13 0
LIST OF TABLES
Table 1: Quality Assurance Requirements 5 0
Table 2: Monitoring Parameters 8 0
Table 3: Analytical Methods 10 0
Table 4: QC Checks for Precision/Accuracy 11 0
LIST OF FIGURES
Figure 1: Responsibilities of Personnel 3 0
Figure 2: Data Collection Sites on Cedar Bay 7 0
APPENDICES
Appendix A: Receipt Document For QAPP Distribution A-l 0
Appendix B: Sample Tracking Sheet B-l 0
Appendix C: Sample Tag C-l 0
TASK1: MODIFY TABLE OF CONTENTS AS REQUIRED.
191
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Original Section I;
I Distribution List
Following individuals will receive copies of approved QAPP.
Project Personnel:
Zack Dempsey
Bob Gilmore
Rebecca Quince
Joan Breedon
Paul Cronin
Robert Mendez
Mark Preston
Diane Jenkins
U.S. EPA Region 6 Personnel:
Alva Smith, 6EN-XQ
Charles Ritchey, 6EN-XQ
Russell Bowen, 6WQ-AG
Petra Sanchez, 6PD-L
Linda Raye Chapman, 6WQ-EW
Karen Alverez, 6PD-S
Steffanie Barnett, 6WQ-EM
Pam Mintz, 6WQ-AG
Other Personnel/Organizations:
Governors Office
Chairman, State Water Management Board
President, State Shellfishermans Association
President, Cedar Bay Homebuilders Association
President, Cedar Bay Chamber of Commerce
President, Cedar Bay Fanners Cooperative
President, Cedar Bay Realators Association
Director AAA-Ace Environmental Sampling and Analytical
J^aboratory (3 Copies)
Each copy of the QAPP will be serial numbered, and a receipt will be signed and returned to
the QA Officer. Example of the receipt document is Appendix A of this document. Recipients
are responsible for assuring they have a current and correct copy of the applicable QAPP.
192
-------
r.nmments: Section I/Element A3: Revise to indicate responsibility for assuring all QAPP
recipients have a current copy of the QAPP rests with project, not with recipients. Appendix
A referred to in this section is missing from the QAPP. Recommend addition of titles beside
names of project personnel.
Requirement: A3 Distribution List
List the individuals and their organizations who will receive copies of the
approved QAPP and any subsequent revisions. Include all managers who are
responsible for implementing the plan, as well as the QA managers and
representatives of all groups involved.
Revised Section I;
I Distribution List
Following individuals will be provided copies of approved QAPP, and all changes to the QAPP,
once approved.
Project Personnel:
Zack Dempsey, ECWC Project Director
Troy Achemann, ECWC Quality Assurance Officer
Bob Gilmore, ECWC Data Processing Supervisor
Rebecca Quince, ECWC Project Officer
Joan Breedon, ECWC Laboratory Director
Paul Cronin, ECWC Field Operations Supervisor
Robert Mendez, QC Coordinator
Mark Preston, QC Coordinator
Diane Jenkins, QC Coordinator
U.S. EPA Region 6 Personnel:
Russell Bowen, 6WQ-AG
Linda Raye Chapman, 6WQ-EW
Steffanie Barnett, 6WQ-EM
Pam Mintz, 6WQ-AG
193
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Other Personnel/Organizations:
Governors Office
Chairman, State Water Management Board
President, State Shellfishermans Association
President, Cedar Bay Homebuilders Association
President, Cedar Bay Chamber of Commerce
President, Cedar Bay Farmers Cooperative
President, Cedar Bay Realators Association
Each copy of the QAPP will be serial numbered, and mailed via "return receipt" mail. The PS
Form 3811, upon its return to the QA Officer, will be maintained as proof of receipt.
Recipients are responsible for assuring the ECWC, Cedar Bay Project Office, has at all times
their current mailing address. The ECWC will maintain records to assure traceability of
QAPPs, by serial number.
Original Section II:
n Project/Task Organization
The individuals responsible for the major aspects of the project are provided in Figure 1.
Comments; Section H/Element A4: Two organizations are listed at bottom of organizational
chart, it is not clear which organization has what if any responsibility in this effort, clarification
is required. If personnel are from different entities they should be defined as to which
organization they work for. Possible conflict of interest situation exists for Bob Gilmore,
requires clarification. Specific responsibilities are not defined in the QAPP. Organization chart
indicates the QA Officer has supervisory control over the Project Officer. There is no direct
communication between the QC staff and the QA Officer. Recommend listing phone numbers
of key staff for ease of access.
Requirements; A4 Project/Task Organization (DQO)
Identify the individuals or organizations participating in the project and discuss
their specific roles and responsibilities. Include the principal data users and the
decision-makers. The project quality assurance manager shall be independent of
the unit generating the data. This does not include senior officials, such as
corporate managers or agency administrators, who are nominally but not
functionally involved in data generation, data use, or decision-making. The
QAPP should also identify the person(s) responsible for approving and accepting
final products and deliverables.
194
-------
Provide a concise organization chart showing the relationships and the lines of
communication among all project participants. Include other data users who are
outside of the organization generating the data, but for whom the data are
nevertheless intended; e.g., modelers, risk assessors, design engineers, lexicolo-
gists, etc. Where direct contact between project managers and data users does
not occur, such as, between a project consultant for a Potentially Responsible
Party and EPA risk assessment staff, the organization chart should show the route
by which information is exchanged. The organization chart should also identify
any subcontractor relationships relevant to environmental data operations. This
chart should be realistic and practical, and should reflect only actual lines of
authority and communication for the project described. Names of current
incumbent occupying a position is essential, as is the identification of vacant
positions.
Revised Section II;
TASK 1. INDIVIDUAL ASSIGNMENT:
Using next page and material from the instructor, create an organizational chart
for the Cedar Bay Project, with the assumption that all efforts will be performed
by ECWC personnel.
TASK 2. GROUP ASSIGNMENT:
Each group will reach a consensus on the Organizational Chart that will be the
most effective for this project. Revise chart as required, to reach consensus.
TASK 3. GROUP ASSIGNMENT:
Once the organizational chart is complete, as a group, write Section n, in the
space below. Section must comply with requirements above.
Project/Task Organization
195
-------
Project/Task Organization (Continued)
196
-------
PROJECT DIRECTOR
Zack Dempsey
(777) 555-1210
PROJECT OFFICER
Rebecca Quince
(777) 555-1211
QA OFFICER
Troy Achemann
(777) 555-1212
LABORATORY MANAGER
Joan Breedon
(777) 555-1213
DATA PROCESSING
Bob Gilmore
(777) 555-1214
FIELD OPERATIONS
Paul Cronin
(777) 555-1215
QC
Robert Mendez
(777) 555-1216
QC
Mark Preston
(777) 555-1217
QC
Diane Jenkins
(777) 555-1218
197
-------
NOTES
198
-------
Project/Task Organization (Continued)
199
-------
Original Section HI;
HI Problem Definition/Background
This project was developed by the State Water Management Board, in conjunction with the
Cedar Bay Technical Institute, to determine the environmental causes of recent fish and shellfish
kills in the area. There is only minimal background studies and information known to exist for
environmental concerns in Cedar Bay, primarily a DDT Study, was performed in 1977, by the
State Agriculture Department, funded by the U.S.D.A., that indicated a level of DDT present
that was far below any level of concern. A limited study was performed in December of 1993,
for Total Suspended Solids (TSS), by the AAA-Ace Environmental Sampling and Analytical
Laboratory, funded by the Cedar Bay Homebuilders Association. Results are not considered
valid due to Laboratory not being able to show traceability of results to sampling events or
locations.
Comments! Section Hi/Element A5: Area is too vague to define what problem is to be solved
or decision is to be made.
Requirement; A5 Problem Definition/Background (DQO)
State the specific problem to be solved or decision to be made. Include sufficient
background information to provide a historical perspective for this particular
project. For example, this would include the regulatory or alleged toxic exposure
situation that led to the need for this project. The discussion must include enough
information about the problem, the past history, any previous work or data, and
any regulatory or legal context to allow a technically-trained reader to make sense
of the project objectives and activities. This discussion also identifies the decision
maker(s) and the principal customer(s) for the results. (When the Data Quality
Objectives [DQO] process has been used, this information should be readily
available.)
Revised Section El:
TASK 1. GROUP ASSIGNMENT: State the Problem; Concisely describe the
problem to be studied. Review prior studies and existing information to gain
an acceptable understanding of the problem.
200
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TASK 2. GROUP ASSIGNMENT: Identify the Decision: Identify the decision that
will solve the problem using new data.
TASK 3. GROUP ASSIGNMENT: Identify the Inputs to the Decision: Identify the
information that needs to be learned and the measurements that need to be.
taken in order to resolve the decision.
TASK 4. GROUP ASSIGNMENT: Define the Study Boundaries: Specify the
conditions (spatial^ time, event related) to which decisions will apply, and
within which the data should be collected.
TASK 5. GROUP ASSIGNMENT: Develop a Decision Rule; Integrate the outputs
from previous steps into an "if....then...." statement that defines the
conditions that would cause the decision maker to choose among alternative
actions.
201
-------
TASK 6. GROUP ASSIGNMENT: Specify Acceptable Limits on Decision Errors;
Define the Decision Maker's acceptable decision error rates based on the
consequences of making an incorrect decision based on data that inaccurately
estimate the true state.
TASK 7. GROUP ASSIGNMENT: Optimize the design: Evaluate information from
the previous steps and generate alternative sampling designs. Choose the most
resource-efficient design that meets all DQOs.
202
-------
Now that the POOs are completed we can revise Section UT.
TASKS. GROUP ASSIGNMENT: Revise Section TTf;
203
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Original Section IV;
IV Project Task Description
This project is to define the nature and extent of contamination or pollution that may be present
in Cedar Bay by:
* The collection and analysis of samples to determine water quality;
* Define the types of chemicals and fertilizers being used in agricultural land management
processes;
* Determine presence of contamination or pollution caused by construction;
* Collect biological specimens for fish and shellfish tissue samples.
All project records and QA/QC data will be retained for at least 5 years after completion of the
project.
All sample collection will be completed within 45 days of the start of the project, and all
analytical work and data validation completed within 60 days of the start of the project. Project
will start within 30 days of receipt of funding.
Comments; Section IV/Element A6: Types of measurements described are not complete, use
of the DQO process would clarify types of data required for a decision. Quality standards, that
would also come from DQO process are not defined. No special personnel/equipment
requirements are defined, list any required or state none are required. No assessment tools are
defined. Where or who retains records is not defined.
Requirements: A6 Project/Task Description (DQO)
Provide a description of the work to be performed. This discussion may not need
to be lengthy or overly detailed, but it should give a overall picture of how the
project will resolve the problem or question described in A5. Describe in general
terms the following, as needed:
Measurements that are expected during the course of the project and the
approach that will be used.
Applicable technical, regulatory, or program-specific quality standards,
criteria, or objectives.
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Any special personnel and equipment requirements that may indicate the
complexity of the project.
The assessment tools needed (i.e., program technical reviews, peer
reviews, surveillances, and technical audits as needed and/or specified by
the QMP) for the project.
A schedule for the work to be performed.
Project and quality records required, including the types of reports
needed.
Now that the DOOs are completed we can revise Section IV.
TASK1. GROUP ASSIGNMENT: Revise Section IV;
IV Project Task Description
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Original Section V:
V Data Quality Objectives for Measurement Data
The Data Quality Objectives Process is not required for this project, as the Data must be of the
highest quality possible from the analytical equipment available at the laboratories performing
the analytical work. To that end the data quality requirements are specified in Table 1, and
were based on the best available advice of several experienced staff members of the Water
Resources Board.
Section V/Element A7: Data Quality Objectives are essential requirements for
QAPPs in Region 6, and are required by EPA Order 5360.1. This project, due to its wide open
possibilities, is in need of structured planning prior to data collection activities.
Requirements: A7 Quality Objectives and Criteria for Measurement Data
(DQO)
Any QAPP must include a statement of the project quality objectives and
measurement performance criteria. EPA recommends that a graded approach be
used in planning, such as the Data Quality Objectives (DQO) Process. Even in
those cases in which the formal DQO Process is not needed, a statement of the
project quality objectives and measurement performance criteria is needed. The
DQO process provides quality objectives based on several factors chosen by the
user of the data. For details on the DQO Process and when it should be used,
please see the EPA guidance document (QA/G-4)9.
The project quality objectives should be stated in quantitative terms to the extent
possible:
Example: UV Treatment of Contaminated Groundwater. "The purpose
of this project is to demonstrate whether or not the residual trichlorethene
concentration in the treated water is less than 0.5 /ig/L at a confidence
level of 95 percent.
Without such quantitative goals, it is difficult to know whether the selected
analytical method is sufficiently sensitive or precise, or whether a sufficient
number of samples are being collected. Sometimes, of course, project objectives
must be stated somewhat less quantitatively, particularly in those situations when
the use of the formal DQO Process is not needed.
9 EPA QA/G-4 ia Guidance for Planning foj^Data Collection UL Support of Environmental Decision MaVmp Using tfac Data (
Process.
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Example: Oil Spill Remediation. "One objective of this project is to
determine whether the populations of clams, mussels, and sand fleas
recover more rapidly in the treated than the untreated area."
Example: Epidemiology Study. "The purpose of this project is to
determine whether the concentrations of indoor NO2 and soot are greater
in the residences of lung cancer patients than in the residences of healthy
persons."
The section on project quality objectives and measurement performance criteria
should address, as appropriate, the following:
the scope of the project; that is, the domain (geographical locale and
.boundaries, environmental medium, time period, etc.) over which conclu-
sions and decisions will apply;
- - the time, resource, or other constraints on the measurement project;
the intended uses of the data, in order of importance and the expected
users of the data;
the specific data needed: type, quantity, matrices involved;
the action levels or standards upon which decisions will be made,
including the detection limits and data reporting units, and the source(s)
of this information;
the population parameter(s) of interest; e.g., mean, maximum, or range,
which specify the form the data will be in when compared against action
levels or standards;
the acceptable level of confidence in the data needed for the stated
purposes or the acceptable amount of uncertainty;
the quantitative sensitivity, precision, bias, and completeness criteria for
each major measurement planned (including all pollutant and process
measurements) for each sample matrix, based on the DQO statements;
the units of expression of the precision and bias goals, which should
correspond to the methods selected to assess data precision and bias; and
the goals for achieving data representativeness and comparability, and
the planning considerations for attaining these goals (unlike precision,
bias, and completeness, these objectives are not usually expressed or
assessed quantitatively);
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Data quality or measurement performance criteria may be typically specified in
terms of detection or quantitation limits, precision, bias, and comparability.
However, simply listing requirements for precision, bias, and completeness
without further discussion is not sufficient. Even statements such as "bias will
be measured as percent recovery of a matrix spike sample" are of marginal help.
In specifying data quality, it is thus essential to specify exactly how such quality
will be measured and interpreted.
Example: A possible statement of bias requirement. "Bias will be mea-
sured a minimum of five times throughout this project by the analysis of
standard reference materials No. 956B. Recovery of TCE from this SRM
should average 85 percent or greater, with a relative standard deviation of
no more than 20 percent."
Data specifications should also be distinguished from the specific QC procedures
that are routinely carried out as part of each measurement. QC procedures are
used while carrying out specific procedures; data specifications are used for
selecting the appropriate methods and QC criteria.
The QAPP may need to define different types of sensitivity (i.e., qualitative,
quantitative, screening, etc.) that may be appropriate for different parts of the
project.
The quantitative goals should reflect the total measurement, if possible, or address
the field, laboratory, and data handling components separately. In the event there
is no basis for defining data quality goals for the project, goals may be estimated
based on prior knowledge of the measurement system, and on method validation
studies (using replicates, spikes, standards, recovery, studies, etc.) Explain the
circumstances under which these goals were established.
If defining quantitative goals is not relevant for certain measurements, indicate
this and state the reason.
Data representativeness is the degree to which the environmental samples truly
reflect the population or material in the real world. It can be affected by the
time, place, and manner by which the samples are collected.
Data comparability is dependent upon consistency in sampling conditions,
selection of sampling procedures, sample preservation methods, analytical
methods, and data reporting units, throughout the project, and with previous
projects with which these results will be compared.
The DQO Process for compliance and/or enforcement projects in the Regions
may not be within the control of the EPA project manager and QA manager.
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The measurement performance criteria are specified in regulations, permits, or
orders. Whether or not those criteria satisfy the requirements of this document,
they are absolutely required. Often the results of the DQO Process are not
expressible in the terms stated here, such as precision, bias, or comparability.
The affected source is simply required to follow a specified method. In such
cases, it is sufficient for the portion of the QAPP addressing the DQO Process
to state that the testing will satisfy the regulatory requirements specified. This
does not, however, relieve the project manager or QA manager from their
responsibility to comply with all other applicable QAPP requirements in this
document.
Now that the DQOs are completed we can revise Section V.
TASK 1. GROUP ASSIGNMENT: Revise Section V;
V Data Quality Objectives for Measurement Data
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Original Section VI;
VI Special Training Requirements/Certification
Sampling Personnel
Since much of the sample collection will be from boats all personnel that are responsible for
actual boat operation must successfully complete a U.S.C.G. Safe Boating course. All sample
collectors will be briefed on the correct methods to take samples, prior to start of sample
collection operations. At least one person in each boat will possess a current Red Cross
Lifesaving Certification. All personnel working in and around the boats shall have successfully
passed Red Cross First Aid and CPR Training courses within the past 3 years.
Analytical Personnel
All analytical chemists will have, at a minimum, a B.S. in Chemistry, and at least two years
experience in Analytical Chemistry.
All biologists will have, at a minimum, a B.S. in Marine Biology or Microbiology, as
applicable, and at least two years experience in their field.
Other Personnel
All other personnel will be qualified for their positions.
Comments: Section VI/Element A9: Courses cited are related to Health and Safety much more
than Data Quality, however they are acceptable. What would be beneficial would be a statement
that none of the work performed would exceed the general knowledge criteria for field sampling
personnel, as defined in the current approved Quality Management Plan. Is the criteria for
analytical personnel acceptable? Other personnel "will be qualified" but qualifications are
lacking, as is the responsible party for that decision.
Requirements: A9 Special Training Requirements/Certification
Identify and describe any specialized training or certification requirements for
personnel in order to successfully complete the project or task. Discuss how such
training will be provided and how the necessary skills will be assured and
documented.
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Now that the DOOs are completed we need to consider revision of Section VI.
TASK 1. GROUP ASSIGNMENT: Revise Section VI;
VI Special Training Requirements/Certification
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Original Section VII:
VII Documentation and Records
All field samplers will maintain an accurate field log that describes as specifically as possible
the location where the sample was collected, its appearance, its sample tag number, and any
information that would be beneficial to the analyst. If a sampling plan cannot be followed
exactly the sampler is to notify the Project Officer, who will issue verbal instructions to the
sampler.
Records of samples sent for analysis will be maintained by the samplers and receipt will be
verified with the analytical laboratory.
Laboratories will provide all analytical data in written format. All individual data sheets will
be dated and signed/initialed by the analyst, the data validator, and their appropriate supervisor.
Data validation will be performed on all data, and both validated and raw data will be provided
to the Project Officer for review, evaluation and approval.
All QA/QC data will be filed.
Comments; Section VH/Element A10: Verbal "documentation" is no documentation, and not
acceptable. While flexibility is needed at times in field operations, obtaining this "flexibility"
should be through a structured process that documents the deviations thoroughly. QA/QC data
being "filed" is not fully acceptable. Filed and retained, with a specific retention time, an
assignment of responsibility for record retention, and perhaps even access procedures may be
required. An SOP could be used here easily, or if a governmental agency, citing the regulatory
or policy document is acceptable.
Requirements; A10 Documentation and Records
Itemize the information and records which must be included in a data report
package for the project or task, and specify the reporting format, if desired.
Documentation can include raw data, filed logs, instrument printouts, and results
of calibration and QC checks. Specify the laboratory data reporting turnaround
time. Specify whether a field sampling and/or laboratory analysis "case
narrative"10 is required to provide a complete description of any difficulties
encountered during sampling or analysis.
Specify any requirements for the final disposition of records and documents from
the project, including location and length of retention period.
10"Case Narrative" refers to an annotated summary of the analytical work performed by a laboratory that
describes in narrative form what activities were performed and identifies any problems encountered. The case
narrative provides additional information to user in interpreting the data received.
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Now that the DQOs are completed we need to consider revision of Section VII.
TASK 1. GROUP ASSIGNMENT: Revise Section VH:
VII Documentation and Records
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VIH Sampling Process Design (Experimental Design)
All sampling procedures and monitoring equipment has been tested to ensure the collection of
valid data.
The frequency of monitoring parameters in this project is uniform. Due to the nature and extent
of the study, collection activities will take place only once.
Grab samples for surface runoff will be collected with a bucket and immediately stored in
water-tight containers for shipping. Two types of biological samples will be collected and
compared for lab analysis. The first set will come from the dead fish/shellfish at the kill sites;
the second set will be living organisms accumulated with netting from Cedar Bay. The tissues
from each set will be tested and analyzed for pesticides and chemicals. The composite water
samples will be collected at intervals using a submersible pump. The results from the 3-foot
interval and the 6-foot interval will then be mixed together in one container. All air samples
will be analyzed for temperature. Also, engine emission pollutants from hydrocarbons will be
measured using an organic vapor analyzer (OVA). As water samples are collected they will be
stored on ice until delivery to a laboratory for analysis.
Comments: Section VHI/Element Bl: Section is unacceptable in total. The experimental
design of the project is not defined, and those requirements stated are not validated by any
specific criteria. Measurements are not identified as to their criticality. Sampling methods are
not well defined by applicable standard method. Process conditions are lacking totally.
Requirements; Bl Sampling Process Design (Experimental Design) (DQO)
Outline in general terms the experimental design of the project and the anticipated
project activities, including the types of samples required, sampling network
design, sampling frequencies, sample matrices, measurement parameters of
interest, and the rationale for the design. If individual sampling plans will be
developed for discrete project phases, include their preparation schedule.
Describe techniques or guidelines to be followed in selecting sampling points and
frequencies, well installation design (when applicable), field decontamination
procedures and materials needed, and sampling equipment. When field screening.
techniques will be used to identify samples for laboratory analysis, describe the
criteria for sample selection. Similarly, when locational data are to be collected,
stored, and transmitted, the method(s) used must be specified and described (or
referenced). Key elements to be addressed include how locations and their bias
are determined.
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All measurements should be classified as critical (i.e., required to achieve project
objectives) or non-critical (informational purposes only). Critical measurements
will undergo closer scrutiny during the review and data gathering process, and
will have first-claim on limited budget resources.
For non-standard methods or unusual sample matrices and situations, appropriate
method validation study information is needed to confirm the performance of the
method for the particular matrix. Such validation studies may included round-
robin studies performed by other organizations. If previous validation studies are
not available, they must be developed during the project and included as part of
the project results. It is very important for this element to include complete
documentation and validation of both the sampling and analytical methodologies.
Identifying standard methods by number, date, and regulatory citation (as
appropriate) is often sufficient. However, many published (and even regulatory)
methods allow the user to select from various options. The method citations
should state exactly which options are being selected.
Measurement of process conditions is often essential to a project (e.g., industrial
plant or control equipment operation associated with a compliance test,
meteorological parameters associated with impoundment volatization). In such
cases, the experimental design must include the design and validation techniques
as described above.
Now that the DOOs are completed we can revise Section VDL
TASK 1. GROUP ASSIGNMENT: Revise Section Vni;
VTfl Sampling Process Design (Experimental Design)
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VHI Sampling Process Design (Experimental Design) Continued
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An alleged "GOOD EXAMPLE" from a previous class for this section is as follows:
Vm. Sampling Process Design (Experimental Design)
Sampling Activities
The project sampling activities will be divided into two phases. Phase I will be designed as a
Pilot Study. The Pilot Study will be conducted as a one time sampling event and will be
completed within 10 days of the start of the project. Appropriate biological, physical and
chemical samples will be taken simultaneously at each site during the sampling event. The
rationale behind conducting the Pilot Study is to eliminate those parameters which did not
contribute to the death of the crabs and to determine the possible causes of death. After
conclusive results of Phase I determine the biological, physical or chemical parameter(s) of
concern (causing the death of the crabs), the project sampling design will enter Phase 11. Phase
11 will be designed as a Surveillance Strategy. The selection of sample sites will be based on
the possible sources of the specific contaminant(s) and areas where the Pilot Study samples
exhibited the highest contaminant concentrations. All sampling collection will be completed
within 45 days of the start of the project.
Pilot Study Biological Sampling Activities
The biological sampling network will be random sampling throughout the kill sites designated
in Figure 2. Data Collection Sites on Cedar Bay and a reference site. Triplicate samples shall
be taken from each site. Living organisms will be netted. Individual organisms will be assigned
a unique number and identified as to species, location, and general physical condition.
NECROPSY of live and morbid crabs/fish from the kill site will be conducted to determine the
biological and toxicological causes of death or effects on the living organisms. Two types of
biological samples will be collected from the kill site. They will be histological and
bacteriological samples. Specific organs from the live and morbid crabs/fish will be collected
for histological examination. Bacteriological samples will be taken from shell surface and
internal organs. The toxicological tests will be conducted on whole crab/fish samples for tissue
concentrations of specific chemicals and metals. Tissues will be collected from dead, live and
morbid organisms.
Pilot Study Chemical Sampling Activities
Water samples will be taken from the same sites as those described above in the biological
sampling activities. Water samples will also be taken from the surface runoff from construction
and farming sites up to three miles upstream from the kill sites. A sample will be taken from
a three mile upstream reference site to determine background concentrations of chemical
parameters. Triplicate samples shall be taken from each site. Sample types will be determined
by the chemical analysis to be performed on each sample as listed on Table 3.
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Pilot Study Physical Sampling Activities
Sediment samples will be taken from the same sites as those described above in the biological
sampling network. Sediment samples will also be taken from the areas of introduction of runoff
from the construction and farming sites described above in the chemical sampling activities.
Triplicate samples shall be taken from each site.
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Original Section IX:
IX Sampling Methods Requirements
Sampling locations were chosen to best represent the area of the largest number offish/shellfish
kills. Figure 2 shows the locations of the data collection sites, and Table 2 lists the sample
types, matrix, monitoring parameters, and frequency of collection at each site.
Because of the nature and extent of the project, only one sampling event per site and sample type
will occur during the confines of the study.
Instantaneous grab samples for surface runoff will be collected at stations CB1-CB3, and will
be representative of contaminants from nearby farming lands. At stations CB4-CB6, composite
water samples from Cedar Bay will be collected at various depths to determine contaminant
characteristics at various depths. Air samples will be taken at stations CB1-CB6. Air
monitoring stations will be located near the main highway and in areas of extensive boating
activities to assess possible pollutants from exhaust emissions.
Random temperature readings from air samples will be taken and recorded in the field log
books. Grab samples for biological testing will be collected at stations FD1-FD2 to determine
if pesticides are present in tissue samples. Stations P1-P3 will collect controlled rainfall samples
to determine quantity and intensity.
Comments: Section DC/Element B2: First sentence too vague. Figure 2, sampling map, has
no scale, no North arrow, is difficult to determine land from water. One sampling event may
not provide all required data, without DQOs it is not easy to determine data requirements.
Requirements: B2 Sampling Methods Requirements
Describe the procedures for collecting samples. Identify the required sampling methods (and/or
equipment, if automated), including any implementation requirements, decontamination
procedures and materials needed, and any specific performance requirements for the method.
For each sampling method, identify any support facilities needed. The discussion should also
address what to do if there is a failure in the sampling or measurement system and who is
responsible for corrective action.
Describe the preparation and decontamination of sampling equipment, including disposal of
decontamination by-products; the selection and preparation of sample containers, sample
volumes, preservation methods, and maximum holding times to sample extraction and/or
analysis. A tabular presentation format is strongly recommended, particularly when two or more
sample matrices are involved.
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Now that the DOOs are completed we need to consider revision of Section IX.
TASK 1. GROUP ASSIGNMENT: Revise Section IX:
IX Sampling Methods Requirements
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An alleged "GOOD EXAMPLE" from a previous class for this section is as follows:
IX. Sampling Method Requirements
Sampling Locations and Techniques
Preliminary sampling points have been chosen for sample collection and are depicted in Figure
2. Table 2 lists the sampling points that will be selected according to each sampling network
design under biological, chemical and physical sampling activities. Locations will be
determined by the possibility of greatest impact on the death of the crabs based on observation
and proximity to shoreline. Sampling types (grab or composite) and techniques will be in
accordance with the procedures described for each specific analysis to be performed on the
biological, chemical and physical parameters as listed in Table 2. All biological, chemical and
physical measurements are critical and take equal priority hi determining the death of the crabs.
Sampling protocol will follow QA methods described in each of the analytical procedures listed
in Table 3 and include QC checks listed in Table 4.
Changes to Figure 2. include a key to identify the north direction and mileage scale, demarkation
between land and water, identification of sample locations and contoured areas to denote the
locations of greatest crab/fish kills, identification of local roadways, and the agricultural and
construction areas contributing to surface runoff. Tributaries that are within three miles of the
kill sites should be denoted. Any changes hi sampling locations should be reflected on Table
2.
Sampling Performance Requirements
Each sample will be collected according to the corresponding FJ>A published methodology
including preservation and implementation requirements, decontamination procedures, and
specific performance requirements. Support facilities for attaining sample containers, sampling
equipment and ice will be arranged through the Carolina Water Commission as needed for each
sampling method.
The Project Officer shall review the techniques that the contract sampling and analytical
laboratory plan to use for sampling equipment preparation, decontamination, disposal of
decontaminated by-products, sample containers, sample volume, preservation methods, holding
times and analytical methods. These shall conform to the methods cited in Table 3.
Should a failure in sampling occur, the contract sampling and analytical laboratory will inform
the Project Officer. The Project Officer shall decide the corrective action.
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Original Section X;
X Sample Handling and Custody Requirements
Samples will be delivered to the designated laboratory within 24 hours of each sampling event
and stored in a freezer onsite at 10 degrees Celsius. The sampling tracking sheet (example at
Appendix B) included with the samples must be checked upon arrival to ensure that all required
information is included, such as sample date, location sampled, type of sample, number of
samples, and the name of the person who sent the samples. Samples will not be discarded until
all analyses have been completed and confirmed.
Comments! Section X/Elemeht B3: How are samples delivered to the laboratory? Holding
times, while contained in the cited Standard Methods, are not listed separately, which would be
of benefit to samplers and others that may not have access to or time to determine holding times.
Sample Tracking Sheet, Appendix B, is not provided. Sample receiving and custody at the
laboratory is not defined. Temperature cites are suspect, and not specific as to media.
Requirements; B3 Sample Handling and Custody Requirements
Describe the provisions for sample handling and shipment, taking into account the
nature of the samples and the maximum allowable sample holding times before
extraction or analysis. Describes the following provisions for sample custody, in
both the field and the laboratory:
Forms, notebooks and procedures to record the exact location and ambient
conditions associated with sample collection, possession and analysis. In
the laboratory, a sample custody log should be maintained.
Examples of sample documentation forms, such as sample labels, custody
seals, and chain-of-custody forms.
Labeling procedures and information entered on the forms, including
sample preservation, if any, and dates and times of sample transfer and
analysis.
Procedures for transferring and maintaining custody of samples.
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Now that the DOOs are completed we need to consider revision of Section X.
TASK1. GROUP ASSIGNMENT: Revise Section X:
X Sample Handling and Custody Requirements
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An alleged "GOOD EXAMPLE" from a previous class for this section is as follows:
X. Sample Handling and Custody Requirements
Sample Preservation
Samples will be delivered to the contract laboratory within 24 hours of the sampling event or
within the holding times specified by the analytical method. Sufficient ice or a freezer shall be
used to ensure proper temperature for preservation described by each analytical method.
Sample Tracking
Each sample will have an attached sample tracking sheet. When sampling personnel deliver the
sample to the laboratory, the tracking sheet shall be checked to ensure that all the required
information is included, such as a sample identification number, sample date, location, type,
analysis to be performed, holding times, and special handling instructions. This tracking sheet
will also serve as a Chain-Of-Custody form. The sampling personnel will sign and date the
Chain-Of-Custody form when they relinquish the sample to the laboratory personnel. The
laboratory personnel will sign and date the Chain-Of-Custody form as they receive the sample
and every time the sample changes custody. The laboratory will maintain its own sample
custody procedures, including a sample custody log book, that will be defensible in a court of
law.
Field Sampling Procedures
Sampling personnel will maintain a field notebook to record the sample identification number,
sample type, location, date, ambient conditions including Ph and dissolved oxygen, and
observations of meteorological conditions. Each sample will have a custody seal.
The Project Officer will review the contract laboratory's sample Chain-Of-Custody and field
sampling procedures. Samples will not be discarded until all analyses have been performed and
results reviewed by the Project Officer.
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Original Section XT:
XI Analytical Methods Requirements
Table 3 provides references for each analytical method that will be used in the project.
Comments: Section XI/Element B4: Footnote 1 of Table 3 cites the 16th edition , which may
or may not be accurate. For waste water it is the 18th edition, for other analytical methods it
may be other editions.
Requirements: B4 Analytical Methods Requirements (DQO)
Identify the analytical methods and/or equipment required, including any
extraction methods needed, laboratory decontamination procedures and materials
needed (such as in the case of hazardous or radioactive samples), waste disposal
requirements (if any), and any specific performance requirements for the method.
The QAPP should also address what to do if there is a failure in the analytical
system and who is responsible for corrective action.
Now that the DQOs are completed we can revise Section XI.
TASK 1. GROUP ASSIGNMENT: Revise Section XI;
XI Analytical Methods Requirements
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XI Analytical Methods Requirements (Continued)
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Original Section
XII QuaKty Control Requirements
Table 4 contains precision/accuracy protocol for QC checks.
A comprehensive plan for the field has been prepared and is available from the QA officer.
Comments; Section Xn/Element B5: Table 4 has no blanks cited for contamination detection.
The "comprehensive" QC plan should be appended to this document.
Requirements; B5 Quality Control Requirements
Discuss QC procedures that should be associated with each sampling, analysis,
or measurement technique. Such specific procedures are performed routinely
during the measurement process, and the results are required to be evaluated
immediately by the technician upon completion of the test. Results must fall
within certain acceptance criteria, or specific corrective action is required. For
projects at or beyond the "proof-of-concept" stage, or for projects employing
well-characterized methods, this section should list each required QC procedure,
along with the associated acceptance criteria and corrective action. Because
standard methods are often vague or incomplete in specifying QC requirements,
simply relying on the cited method to provide this information is usually
insufficient. In any case, QC procedures must frequently be modified on a
project-specific basis in order to meet data specifications.
QC procedures must be compatible with the data specifications discussed above.
This means, if a measurement must be precise within +20 percent, the stability
of calibration checks must be somewhat better than ±20 percent. For some
research-oriented projects, the analytical technique may not be available until well
into the project. In such instances, detailed QC requirements may not need to be
specified in the initial QAPP. More appropriately, the initial document might
specify general requirements for precision, bias, and detection limits, and the
means of achieving these goals would be developed by the principal investigator
during the course of the project.
List the required QC checks, such as matrix spikes, duplicates, blanks, laboratory
control samples, surrogates, or second column confirmation. State the frequency
of analysis for each type of QC check, and the spike compounds and levels. State
or reference the required control limits for each QC check and corrective action
required when control limits are exceeded.
Describe the procedures to be used to calculate each of the QC statistics,
including the QC checks described in the preceding paragraph as well as precision
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and bias. Copies of the formulas are acceptable as long as the accompanying
narrative or explanation specifies clearly how the calculations will address difficult
situations such as missing data values and "less than" or "greater than" values.
Now that the DOOs are completed we can revise Section XEL
TASK1. GROUP ASSIGNMENT: Revise Section XII;
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Original Section YTTT?
Xin Instrument/Equipment Testing, Inspecting, and
Maintenance Requirements
All field and analytical instruments and equipment will be inspected and tested daily, prior to
operation. Any instruments and equipment not passing the daily inspection and test will not be
used unless there are no alternates available. Operation and preventative maintenance for field
equipment can be found in the manufacturer's instructions of each piece of equipment.
Laboratory preventative maintenance procedures are provided in the laboratory QA Project Plan.
Comments! Section Km/Element B6: No equipment can be used that is not operating
correctly, regardless of availability of replacement equipment. Precision checks must be at least
as precise as precision requirements for data. If Statistical Process Control Charts are
maintained and evaluated this must be defined here.
Requirements! B6 Instrument/Equipment Testing, Inspection, and
Maintenance Requirements
Discuss how inspections and acceptance testing, including the use of QC
standards and reference materials, of environmental sampling and measurement
systems and their components must be performed and documented to assure their
intended use as specified by the design. Identify and discuss how final acceptance
shall be performed by independent personnel (e.g., personnel other than those
performing the work). Discuss how deficiencies are to be resolved when
acceptance criteria are not met, and how and when re-inspection will be
performed as necessary.
Discuss how periodic preventive and corrective maintenance of measurement or
test equipment shall be performed to ensure availability and satisfactory
performance of the systems. Identify the equipment and/or systems requiring
periodic maintenance. Discuss how the availability of critical spare parts,
identified in the operating guidance and/or design specifications of the systems,
will be assured and maintained.
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Now that the DOOs are completed we can revise Section Xin.
TASK 1. GROUP ASSIGNMENT: Revise Section XIH:
Instrument/Equipment Testing, Inspecting, and
Maintenance Requirements
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Original Section
XIV Instrument Calibration and Frequency
All thermometers are precalibrated by the National Institute of Science and Technology. The
organic vapor analyzer will be calibrated according to the manufacturer's instructions prior to
each sampling event.
Laboratory calibration procedures are defined in the laboratory QA Project Plan.
)
Comments; Section XTWElement B7: Laboratory calibration procedures are defined in the
laboratory QAPP. What laboratory? QAPP from the laboratory should be provided.
Requirements; B7 Instrument Calibration and Frequency
Identify all tools, gauges, instruments, and other sampling, measuring, and test
equipment used for data collection activities affecting quality that must be
controlled and, at specified periods, calibrated to maintain bias within specified
limits. Discuss how calibration shall be conducted using certified equipment
and/or standards with known valid relationships to nationally recognized
performance standards. If no such nationally recognized standards exist,
document the basis for the calibration. Identify the certified equipment and/or
standards used for calibration. Indicate how documentation of calibration shall
be maintained and be traceable to the instrument.
Now that the DOOs are completed we can revise Section XIV.
TASK1. GROUP ASSIGNMENT: Revise Section XIV:
XTV Instrument Calibration and Frequency
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TASK 1. GROUP ASSIGNMENT: Revise Section XIV;
XIV Instrument Calibration and Frequency (Continued)
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Original Section XV?
XV Inspection/Acceptance Requirements for Supplies
and Consumables
All supplies and consumables, upon receipt, will be verified with shipping/receiving documents,
and purchase order to verify quantity ordered equals quantity received. Incorrect quantity
shipments will be reported to purchasing agent for resolution with the supplier. Incorrect items
will be evaluated by receiving clerk for suitability of use.
Comments: Section XV/Element B8: Section is too vague and non-specific. No inspection
criteria for specific items, no list of what the items will be. In this instance quantity ordered
equals quantity received is the sole inspection criteria for all items. Receiving clerk making
evaluation of suitability of non-conforming items is not acceptable.
Requirements; B8 Inspection/Acceptance Requirements for Supplies and
Consumables
Discuss how and by whom supplies and consumables shall be inspected and
accepted for use in the project. Supplies and consumables are those items
necessary to support the sampling and analytical operation. They include, but are
not limited to: sample bottles, calibration gases, reagents, hoses, materials for
decontamination of sampling equipment, deionized water, and potable water.
Identify acceptance criteria for such supplies and consumables in order to satisfy
the technical and quality objectives of the project or task.
Now that the DQOs are completed we can revise Section XV.
TASK 1. GROUP ASSIGNMENT: Revise Section XV;
XV Inspection/Acceptance Requirements for Supplies
and Consumables
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XV Inspection/Acceptance Requirements for Supplies
and Consumables (Continued)
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Original Section XVT?
XVI Data Acquisition Requirements (Non-direct Measurements)
Existing data from the limited study performed for Total Suspended Solids (TSS), by the AAA-
Ace Environmental Sampling and Analytical Laboratory, funded by the Cedar Bay Homebuilders
Association has been evaluated and results are not considered valid due to Laboratory not being
able to show traceability of results to sampling events or locations. If reconstruction of samplers
logs is accomplished that provides traceability of sample location to analytical results^ those
individual data are considered acceptable for use as background material.
Comments; Section XVI/Element B9: Acceptable section.
Requirements; B9 Data Acquisition Requirements (Non-direct
Measurements)
Identify the type of data acquired from non-measurement sources such as
computer data bases, spreadsheets, and programs, and literature files. Define
acceptance criteria for the use of the data in this project. Discuss any limitations
on the use of the data based on uncertainty in the quality of the data and discuss
the nature of that uncertainty.
Now that the DQOs are completed we may need to revise Section XVI.
TASK 1. GROUP ASSIGNMENT: Revise Section XVI;
XVI Data Acquisition Requirements (Non-direct Measurements)
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Original Section XVII;
XVII Data Management
The data management system used by the laboratory performing the analytical work shall be
described in the laboratory QA Project Plan.
Comments; Section XVn/Element BIO: Laboratory data management procedures are defined
in the laboratory QAPP. What laboratory? QAPP from the laboratory should be provided. No
mention of data management by project staff, regardless of source, no mention of procedures
for data generated by project personnel.
Requirements; BIO Data Management
Outline the project data management scheme, tracing the path of the data,
beginning from receipt from the field or laboratory, to the use or storage of the
final reported form. Describe the standard record-keeping procedures, document
control system, and the approach used for data storage and retrieval on electronic
media. Discuss the control mechanism for detecting and correcting paperwork
errors and for preventing loss of data during data reduction (i.e., calculations),
data reporting, and data entry to forms, reports, and databases. Provide examples
of any forms or checklists to be used.
Identify and describe all data handling equipment and procedures that will be used
to process, compile, and analyze the data. This includes procedures for
addressing data generated as part of this project as well as data from other
sources. The specifications should include any required computer hardware and
software and should address any specific performance requirements for the
hardware/software configuration used. Describe the procedures that will be
followed to demonstrate acceptability of the hardware/software configuration
required.
Now that the DQOs are completed we can revise Section XVII.
TASK 1. GROUP ASSIGNMENT: Revise Section XVH;
XVTI Data Management
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TASK 1. GROUP ASSIGNMENT: Revise Section
XVII Data Management
237
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Original Section XVffl;
XVin Assessments and Response Actions
Performance and systems audits will occur in the field and the laboratory. Field audits will
consist of the staff overseeing all sampling procedures. Laboratory audits will include double
blind performance evaluation samples to assess the efficiency of laboratory staff. The results
will be given to Rebecca Quince for review.
Comments! Section XVHI/Element Cl: Section is to vague and non-specific to be of value.
Revise section thoroughly, addressing all criteria required for this section.
Requirements: Cl Assessments and Response Actions
Identify the number, frequency, and type of assessment activities needed for this
project. Assessments include, but are not limited to, the following:
surveillance,
peer review,
management systems review,
readiness review,
technical systems audit,
performance evaluation,
audit of data quality, and
data quality assessment.
Discuss the information expected from the assessment and success criteria (i.e.,
goals, performance objectives, acceptance criteria specifications, etc.) for each
assessment proposed. For each proposed assessment, list the approximate
schedule of activities, and discuss the information expected from the assessment
and the criteria for success. For any planned self-assessments (utilizing personnel
from within the project groups), identify the participants and their exact
relationship within the project organization. For independent assessments,
identify the organization and person(s) that will perform the assessments. Discuss
how and to whom the results of the assessments will be reported. Define the
authorities of the assessors. For example, if the assessors should order a work
suspension upon finding a significant condition, this section delineates clearly
their authority to do so. Define explicitly the unsatisfactory conditions under
which the assessors are authorized to act. Recognizing that assessments may be
needed at any time during the project, provide a schedule for the assessments to
be performed.
Discuss how response actions to non-conforming conditions will be addressed and
by whom. Identify who is responsible for implementing the response action.
Describe how response actions will be verified, validated, and documented.
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Now that the DQr>« are completed we mav need to revise Section XVm.
TASK 1. GROUP ASSIGNMENT: Revise Section XVm:
XVHI Assessments and Response Actions
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Original Section XIX;
XIX Reports to Management
Interim QA reports will be issued bi-weekly during the course of the study. A final report will
be issued at the termination of the project, and is the responsibility of the Project Director.
Comments; Section XIX/Element C2: No criteria is cited for what must be addressed in either
the bi-weekly reports or the final report. Responsibility for preparation of the bi-weekly reports
is not assigned. Distribution is not stated for bi-weekly or final reports.
Requirements; C2 Reports to Management
Identify the frequency, content, and distribution of reports issued to inform
management of the following:
status of the project;
results of performance evaluations and system audits;
results of periodic data quality assessments; and
significant quality assurance problems and recommended solutions.
Identify the responsible organization(s) that will prepare the reports, and the
recipients of the reports. Identify any other status reports to management as well
as their content and frequency.
Now that the DQOs are completed we may need to revise Section XIX.
TASK 1. GROUP ASSIGNMENT: Revise Section XIX;
XIX Reports to Management
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Original Section
XX Data Review, Validation, and Verification Requirements
All data reduction procedures will follow the method specifications for performing calculations,
found in Bloch et al (1986). All data will be reviewed 100%. Data validation processes will
include verification that all QA criteria have been met. Data reporting procedures will ensure
that all data outlined have been evaluated to determine if data quality is adequate.
Comments: Section XX/Element Dl: Section is to vague and non-specific to be of value.
Revise section thoroughly, addressing all criteria required for this section.
Requirements; Dl Data Review, Validation, and Verification Requirements
State the criteria used to review and validate - that is, accept, reject, or qualify -
data, in an objective and consistent manner. Provide examples of any forms or
checklists to be used.
Project-specific calculations or algorithms should be discussed. Some projects
may require special calculation during or after data generation:
Example: Indoor Air Pollution. Consider a project that is meant to
estimate the number of residences within the greater Washington, D. C.,
area exhibiting NO2 concentrations greater than 100 /xg/m3 at a frequency
of 30 of more days per year. Once NO2 measurements are available, one
would attempt to extrapolate the limited information to the greater
metropolitan area. The QAPP should explain the statistical techniques that
will be employed, including how uncertainties will be assessed.
For other projects, one may only need to calculate a mass balance of a de-
struction/removal efficiency. While these are much simpler requirements, the
specific formulas and data inputs should be listed. This approach helps assure
that at least the minimum necessary data are collected for the intended inter-
pretation (even if additional interpretation schemes are eventually employed).
Now that the DOOs are completed we mav need to revise Section XX.
TASK1. GROUP ASSIGNMENT: Revise Section XX:
XX Data Review, Validation, and Verification Requirements
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XX Data Review, Validation, and Verification Requirements (Cont.)
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Comments: Element D2: Not Addressed.
Requirements: D2 Validation and Verification Methods
Describe the process to be used for validating and verifying data, including the
chain of custody for data throughout the life cycle of the project or task. Discuss
how issues shall be resolved and the authorities for resolving such issues.
Describe how the results are conveyed to data users. The review of data can
include checks of the following: transmittal errors, field and laboratory QC data,
detection limits, instrument calibration, special sampling or analysis conditions,
performance evaluations, technical systems audits, contract compliance issues
(e.g., holding times), and statistical data treatments, such as tests for
identification of potential outliers.
TASK1. GROUP ASSIGNMENT: Write Section XXI:
XXI Validation and Verification Methods
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Comments: Element D3: Not Addressed.
Requirements: D3 Reconciliation with Data Quality Objectives
Describe how the results obtained from the project or task will be reconciled with
the results of the DQO Process. Describe how issues will be resolved. Discuss
how limitations on the use of the data will be reported to decision makers.
Identify the procedures used to assess precision, bias, and completeness for the
project data.
A methodology has been developed to assist users in reconciling data results with
the DQOs. The Data Quality Assessment (DQA) Process07* is used to assess the
scientific and statistical quality of data collected for a specific purpose. In the
DQA Process, the data will be analyzed scientifically to inspect for technical
anomalies and to judge that the context of the data is correct. At the same time,
the data will be evaluated statistically to confirm that the statistical model was
correct by selecting a statistical test and validating the test by verifying
assumptions, such as for distribution and independence. The outcome of the
DQA process will indicate whether a decision can be made using the existing data
or additional data must be collected.
TASK 1. GROUP ASSIGNMENT: Write Section XXII:
XXII Reconciliation with Data Quality Objectives
244
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REFERENCES
Bloch, S. Conducting Field Research in Agricultural Hydrology Agricultural Handbook No. 95.
Washington, D.C.: U.S. Department of Agriculture, 1986.
245
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NOTES
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APPENDIX A
TERMS AND DEFINITIONS FROM BOTH R-2 AND R-5
assessment - the evaluation process used to measure the performance or effectiveness of a system
and its elements. As used here, assessment is an all-inclusive term used to denote any of the
following: audit, performance evaluation, management systems review, peer review, inspection, or
surveillance.
audit (quality) - a systematic and independent examination to determine whether quality
activities and related results comply with planned arrangements and whether these arrangements
are implemented effectively and are suitable to achieve objectives.
calibration - comparison of a measurement standard, instrument, or item with a standard or
instrument of higher accuracy to detect and quantify inaccuracies and to report or eliminate those
inaccuracies by adjustments. (R-5 Only)
chain-of-custody - an unbroken trail of accountability that ensures the physical security of
samples, data, and records.. (R-5 Only)
contractor - any organization or individual that contracts to furnish services or items or perform
work; a supplier in a contractual situation.. (R-5 Only)
data quality assessment - a statistical and scientific evaluation of the data set to determine the
validity and performance of the data collection design and statistical test, and to determine the
adequacy of the data set for its intended use.
data usability - the process of ensuring or determining whether the quality of the data produced
meets the intended use of the data.. (R-5 Only)
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
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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 processes - manufactured or natural processes that produce discharges to or that
impact the ambient environment.. (R-5 Only)
environmental programs - work or activities involving the environment, including but not
limited to: characterization of environmental processes and conditions; environmental monitoring;
environmental research and development; the design, construction, and operation of
environmental technologies; and laboratory operations on environmental samples.
environmental technology - an all-inclusive term used to describe pollution control devices and
systems, waste treatment processes and storage facilities, and site remediation technologies and
their components that may be utilized to remove pollutants or contaminants from or prevent them
from entering the environment: Examples include wet scrubbers (air), soil washing (soil),
granulated activated carbon unit (water), and filtration (air, water). Usually, this term will apply
to hardware-based systems; however, it will also apply to methods or techniques used for
pollution prevention, pollutant reduction, or containment of contamination to prevent further
movement of the contaminants, such as capping, solidification or vitrification, and biological
treatment.
financial assistance - the process by which funds are provided by one organization (usually
government) to another organization for the purpose of performing work or furnishing services or
items. Financial assistance mechanisms include grants, cooperative agreements, performance
partnership agreements, and government interagency agreements.. (R-5 Only)
graded approach - the process of basing the level of application of managerial controls applied
to an item or work according to the intended use of the results and the degree of confidence
needed in the quality of the results.
independent assessment - an assessment performed by a qualified individual, group, or
organization that is not a part of the organization directly performing and accountable for the
work being assessed.
information resources management - the planning, budgeting, organizing, directing, training
and controls associated with information. The term encompasses both information itself and
related resources such as personnel, equipment, funds and technology.. (R-5 Only)
-------
inspections/examination or measurement of an item or activity to verify cbnformance, to specific
requirements.
management - those individuals directly responsible and accountable for planning, implementing,
and assessing work.. (R-2 Only)
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.. (R-2 Only)
method - a body of procedures and techniques for performing an activity (e.g., sampling,
modeling, chemical analysis, quantification) systematically presented in the order in which they are
to be executed.. (R-5 Only)
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.. (R-2 Only)
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.. (R-2 Only)
participant - when used in the context of environmental programs, an organization, group, or
individual that takes part in the planning and design process and provides special knowledge or
skills to enable the planning and design process to meet its objective.. (R-5 Only)
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.. (R-5 Only)
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.
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process - a set of interrelated resources andactivities- which transforms inputs into, outputs.,
.Examples of processes include analysis, design, data collection, operation, fabrication, and
calculation.. (R-2 Only)
quality - the totality of features and characteristics of a product or service that bear on its ability
to meet the stated or implied needs and expectations of the user.
quality assurance (QA) - an integrated system of management activities involving planning,
implementation, documentation, assessment, reporting, and quality improvement to ensure that a
process, item, or service is of the type and quality needed and expected by the client.
quality assurance manager - the individual designated as the principal manager within the
organization having management oversight and responsibilities for planning, documenting,
coordinating, and assessing the effectiveness of the quality system for the organization.. (R-5
Only)
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.. (R-2
Only)
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.
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* The quality system provides the framework for planning; implementing,,:; dqcumenting^ancL ^
assessing work performed by the organization and for carrying out required QA and QC activities.
readiness review - a systematic, documented review of the readiness for the start-up or continued
use of a facility, process, or activity. Readiness reviews are typically conducted before proceeding
beyond project milestones and prior to initiation of a major phase of work.
record - a completed document that provides objective evidence of an item or process. Records
may include photographs, drawings, magnetic tape, and other data recording media.
self-assessment - assessments of work conducted by individuals, groups, or organizations directly
responsible for overseeing and/or, performing the work.. (R-2 Only)
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.. (R-5 Only)
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,'
-------
validation - confirmation by examination and provision of objective evidence thaLthe 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..
(R-5 Only)
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.. (R-5 Only)
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IMPORTANT INFORMATION
U.S. EPA Region 6 Quality Assurance Staff:
Regional Quality Assurance Manager, 6MD:
Don Johnson - (214) 665-8343, Fax (214) 665-7082, email:
Johnson.donald(g),epa.gov
Programmatic Divisional QA Officers:
Charles Ritchey, 6PD, (214) 665-8350, email:
ritchey.charles@epa.gov
Dr. Randall Romig, 6WQ-D, (214) 665-8346, email:
romig.randall@iepa.gov
Walt Helmick, 6SF-D, (214) 665-8373, email:
helmick.walt@epa.gov
Gerald Carney, 6EN-XP, (214) 665-6523, email:
carney.gerald(g),epa.gov
Mailing Address:
Name (6 -_)
U.S. EPA Region 6
1445 Ross Avenue
Dallas, Texas 75202-2733
Call for any assistance we can give you on QA matters, such as finding
out about the status of your QA Plans, advice on writing your QA Plans,
or attending one of our QA Courses.
253
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NOTES
254
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