United States
Environmental
Protection Agency
Great Lakes
National Program
Office
EPA905-R-02-009
October 2002
Quality Management Plan
for the Great Lakes National
Program Office
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Quality Management Plan Approvals
Document Title:
Organizational Title:
Address:
Quality Management Plan for the Great Lakes National
Program Office
Great Lakes National Program Office
77 West Jackson Street
Chicago, IL 60604
Nancy Wentworth
Director, Office of Environmental foformation-Quality
Staff - J
Thomas Skinner
Great Lakes National ProgranvManager
yvicki
icki Thomas
Chief, Policy Coordination ^Communications Branch
L
Paul Horvatin
Chief, Monitoring Indicators & Reporting Branch
7 u U*"-7C"'V
David Cowgill
Date
Date
Date
Date
Date
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% UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
* WASHINGTON, D.C. 20460
APR 2 8 2003
OFFICE OF
ENVIRONMENTAL INFORMATION
MEMORANDUM
SUBJECT: Approval of the Quality Management Plan for the Great Lakes National Program
Office
FROM: Naney W. Wentworth
Director, Quality Staff (2811R)
TO: Thomas V. Skinner
Great Lakes National Program Manager
I am pleased to approve the Great Lakes National Program Office Quality Management
Plan (QMP) for a period not to exceed five years from the date of this memorandum. This
approval was based on a comparison of the QMP to the specifications contained in Chapter 3 of
EPA Order 5360 (May 2000), EPA Quality Manual for Environmental Programs. Please
remember that organizational and/or mission changes may make it necessary for you to revise
and resubmit the QMP before the five year approval period expires, per Section 3.2.4 of EPA
Order 5360. If there are any questions about the review and approval, please call me at
(202) 564-6830.
cc: Louis Blume
Internet Address (URL) • http://www.epa.gov
Recycled/Recyclable • Printed with Vegetable Oil Based Inks on Recycled Paper (Minimum 30% Postconsumer)
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Table of Conten ts
Acknowledgments vii
Acronyms and Abbreviations ix
Section 1 Quality Management and Organization 1
1.1 Introduction 1
1.2 Quality Management Policy, Goals, and Objectives 3
1.3 Program Description 5
1.3.1 Mission 6
1.3.1.1 Accomplishing the Mission 7
1.3.1.2 Setting Goals to Accomplish the Mission 8
1.3.2 GLNPO Activities and Programs 8
1.3.3 Base Monitoring Program 10
1.4 Organization of the Great Lakes National Program Office 11
1.4.1 GLNPO Functional Teams 12
1.4.2 Key Personnel and Associated Responsibilities 14
1.4.2.1 GLNPO Director 14
1.4.2.2 Branch Chiefs/Management Advisors 15
1.4.2.3 Team Leaders 16
1.4.2.4 Team Members 17
1.4.2.5 Quality Manager 17
1.4.2.6 Project Officer 19
1.4.2.7 Principal Investigator 20
1.5 Working with EPA Regions and States 20
1.6 History of Quality Management at GLNPO and Organizational Acceptance 21
Section 2 Quality System Components 22
2.1 Quality Management Plans 22
2.2 Project Quality Objectives and Systematic Planning 22
2.3 Quality System Documentation 23
2.3.1 GLNPO's Graded Approaches to Quality System Documentation 24
2.4 Standard Operating Procedures 25
2.5 Training 26
2.6 Tracking Environmental Information Collection Activities 26
2.7 Quality Management Team Monthly Reports to Management 31
2.8 Reviews of Quality System Implementation at the Branch Level 31
2.9 Annual Report and Workplan 32
2.10 Quality System Audits and Technical System Audits 32
Section 3 Personnel Training and Qualifications 33
3.1 Quality Manager Training 33
3.2 GLNPO Personnel Quality System Training 33
Section 4 Procurement of Items and Services 35
4.1 Procurement of Items 35
4.2 Procurement of Services 36
4.2.1 Contracts 40
4.2.2 Assistance Agreements 42
4.2.3 Special Conditions 45
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Section 5 Document Control and Records 46
5.1 Management of Documents and Records 46
5.2 Version Control 46
5.3 Information Quality Guidelines 47
5.3.1 Standard Operating Procedures for Pre-dissemination Review 47
5.3.2 Standard Operating Procedures for Request for Correction 47
Section 6 Information Management 48
6.1 GLNPO Information Management System 48
6.2 Hardware and Software Requirements 50
6.3 Reporting Standards 51
6.3.1 GLNPO Locational Data Policy 52
6.4 Information Security 52
Section 7 Quality Planning 53
7.1 Project Planning and Scoping 53
7.2 Documentation 55
7.2.1 GLNPO's Graded Approaches to Quality System Documentation 58
7.2.1.1 Quality System documentation for programs 59
7.2.1.1.1 Cluster Grants 60
7.2.1.1.2 Consortium Grants 61
7.2.1.1.3 Repeating Projects of Similar Scope 61
7.2.1.2 Quality System Documentation for Projects 63
7.2.1.2.1 Existing Data/Modeling 63
7.2.1.2.2 Tribal Grants 64
7.2.1.2.3 Sediment Assessment 64
7.2.1.2.4 Habitat/Ecosystem Restoration Management 65
7.2.1.2.5 Ambient Monitoring and Research Demonstration .... 65
7.2.1.2.6 Pollution Prevention and Environmental Education ... 65
7.2.1.2.7 Volunteer Monitoring 65
7.2.2 QA Annual Report and Workplan 68
7.3 Peer Review 68
7.4 Health and Safety Issues 69
Section 8 Quality Implementation of Work Processes 71
8.1 Intramural Activities 71
8.2 Extramural Activities 71
8.3 Communication 72
8.4 Dispute Resolution 72
Section 9 Quality Assessment and Response 73
9.1 Quality Systems Audits and Technical Systems Audits 73
9.2 Performance Evaluations 74
9.3 Project Assessments 75
9.4 Assessment Implementation 76
9.5 Data Quality Assessments 77
9.6 Assessment Reporting 79
9.7 Response Actions 79
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Section 10 Quality Improvement 80
10.1 Program Review 80
10.2 Project Reviews 81
References 82
Glossary 85
Appendices
A. EPA Quality Manual for Environmental Programs (EPA Manual 5360 Al) and Policy and Program
Requirements for the Mandatory Agency-wide Quality System (EPA Order 5360.1 A2)
B. Great Lakes National Program Office Team Mission Statements
C. Monthly Quality Assurance Status Tracking Sheet
D. Great Lakes National Program Office Data Standard: Quality Assurance/Quality Control Codes
E. Great Lakes National Program Office Information Security Plan
F. Suggested Quality System Documentation Checklist
G. EPA Requirements for Quality Assurance Project Plans (EPA QA/R-5)
H. Project Inventory and Approval Form, Grant Agreement
I. Project Inventory and Approval Form, Interagency Agreement
J. Quality Assurance Project Plan and Quality Management Plan Checksheets
K. Examples of GLNPO's Graded Approaches to Quality System Documentation
L. Peer Review Checklists
M. Protocol to Address Missed Requirements in Great Lakes National Program Office Assistance
Agreements
N. Example of Delinquency Notification Letter
O. Quality System Documentation Status Tracking Sheet
P. Example Audit Checksheet
Q. Audit Finding Response Form
R. Examples of Quality Assurance/Quality Control Analysis Checklists
S. GLNPO Quality System Documentation Review Procedures and Tracking
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Acknowledgments
The authors appreciate the reviewer comments received by the U.S. Environmental Protection
Agency, Great Lakes National Program Office staff, and would like to thank the following individuals for
their technical assistance during the revision to this document. From the U.S. Environmental Protection
Agency Great Lakes National Program Office, we thank Mike Russ for his in-depth review of sections
pertaining to budgets and planning and Scott Cieniawski and Demaree Collier for their sediment quality
assurance project plan example and quality assurance/quality control analysis checklists (both are
included in appendices to this quality management plan). We thank Mary Beth Giancarlo of Oak Ridge
Institute for Science and Education (ORISE) for her coordination, review, and organization of various
aspects of this document. We thank Judy Schofield of DynCorp Science and Engineering Group for
assisting the GLNPO QA Manager in assembling and editing the document and Kim Malloy for
document production.
For supporting development of GLNPO's quality system the authors thank from the Great Lakes
National Program Office, Gary Gulezian and Paul Horvatin for supporting the quality manager and the
direction he has taken GLNPO's quality program. We thank GLNPO's Quality Management Team
members including Scott Cieniawski, Demaree Collier, Mary Beth Giancarlo, Duane Heaton, Sandra
Hellman, Edward Klappenbach, Marvin Palmer, and Vergel Santos for assisting in the development and
implementation of GLNPO's quality program. We thank Environmental Careers Organization (ECO)
and ORISE for the series of student interns who have helped implement the quality program including
Lucy Stanfield, John Goldsmith, John Crncic, Simon Manoyan, Dwayne Holmes, Allison Witt, and
Kimberly Hill and we thank Ethel Crisp of Region 5 for providing such well-qualified trainees.
Additionally, the authors would like to thank the EPA Graded Approach Workgroup who have
helped shape our graded approaches to GLNPO investments, which are new to this document.
Workgroup members include: Patricia Lafornara of Office of Environmental Information Quality Staff
and Co-Chair of the Workgroup; Louis Blume of GLNPO and Co-Chair of the Workgroup; Marcus
Kantz of Region 2; David Taylor of Region 9; Kevin Bolger of Region 5; William Telliard and Marion
Kelly of Office of Water; Thomas Wagner of Office of Research and Development, National Health and
Environmental Effects Research Laboratory; Nancy Parry of Office of Research and Development,
National Center for Environmental Research; Michael Papp of Office of Air Quality Planning and
Standards; Joan Karnauskas of Region 5; Betsy Grim of Office of Prevention, Pesticides, and Toxic
Substances; and Mark Doehnert of Office of Radiation and Indoor Air. Special thanks to William
Telliard and Marion Kelly for contractual support and also technical support regarding analytical
methods and regulatory implications surrounding GLNPO programs.
The authors thank the EPA Quality Staff for the guidance they have provided for the last 10 years
and the forums they provide for debate, such as conference calls, annual meetings, and training sessions.
We also thank the EPA Quality Staff for their flexibility in assisting us in developing graded approaches
that apply to our activities. Special thanks to Patricia Lafornara of the Quality Staff who was an
instrumental reviewer and sounding board for the approaches discussed here. Finally, special thanks to
Michael Papp for his initial drafting of GLNPO's QMP from 1992 to 1996, which provided the base
QMP that we have enhanced here.
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Acronyms and Abbreviations
AOC Areas Of Concern
ARCS Assessment and Remediation of Contaminated Sediments
CRT Communications & Reporting Team
DCM Document Control Manager
DOE Department of Energy
DQA Data Quality Assessment
DQOs Data Quality Objectives
EICAA Environmental Information Collection and Assessment Activity
EMIT Environmental Monitoring & Indicators Team
EPA Environmental Protection Agency
EPAR EPA Acquisition Regulations
ERST Ecological Protection Restoration Team
FAR Federal Acquisition Regulations
FIPS Federal Information Processing Standards
FWS Fish and Wildlife Service
GIS Geographical Information Systems
GLNPO Great Lakes National Program Office
HST Health & Safety Team
IAG Interagency Agreement
IMS Information Management Staff
IMDI Information Management & Data Integration Team
ISP Information Security Plan
1ST Invasive Species Team
LaMP Lakewide Management Plans
LAN Local Area Network
MQOs Measurement Quality Objectives
MT Management Team
NIST National Institute of Standards and Technology
OEI Office of Environmental Information
OMB Office of Management and Budget
ORD Office of Research and Development
P2 Pollution Prevention Team
PBT Program Planning & Budgeting Team
PE Performance Evaluation
PTD Project Tracking Database
QA Quality Assurance
QAARWP Quality Assurance Annual Report and Workplan
QMP Quality Management Plan
QAPP Quality Assurance Project Plan
QC Quality Control
QSA Quality System Audits
RAP Remedial Action Plans
SART Sediment Assessment & Remediation Team
SIRMO Servicing Information Resources Management Officer
SOP Standard Operating Procedure
SOW Statement or Scope of Work
TSA Technical System Audit
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Section 1
Quality Management and Organization
1.1 INTRODUCTION
The Environmental Protection Agency (EPA) Order 5360.1 A2 Policy and Program
Requirements for the Mandatory Agency-wide Quality System, May 2000 (Appendix A), establishes
policy and program requirements for the preparation and implementation of quality management systems.
The order requires that all EPA organizational units participate in a centrally managed quality assurance
(QA) program. This Agency-wide system management system provides the necessary elements to plan,
implement, document, and assess the effectiveness of quality assurance (QA) and quality control (QC)
activities applied to environmental programs conducted by or for EPA. The intent is to develop a
consistent approach to environmental decisions that ensures the collection of supporting data that are
scientifically sound, legally defensible, and of known and documented quality. The Office of
Environmental Information's (OEI's) Quality Staff is responsible for developing, coordinating and
directing the implementation of the Agency's QA program.
To document adherence to EPA Order 5360.1 A2, EPA requires each organizational unit to
develop a quality management plan (QMP) per the specifications in Chapter 3 of EPA's Manual 5360
Al, EPA Quality Manual for Environmental Programs ( included as Appendix A of this QMP). The
QMP is management's statement of the process that will govern the QA activities for a given
organization. The QMP defines an organization's QA-related policies, areas of application, roles,
responsibilities and authorities of staff, and the management and technical practices that assure that
environmental data used to support decisions are:
*• of adequate quality and usability for their intended purpose, and
*• where necessary, legally and scientifically defensible.
This document defines the Great Lakes National Program Office's (GLNPO's) quality system.
GLNPO is a geographically-focused office, whose mission is to lead and coordinate United States efforts
to protect and restore the Great Lakes. This QMP is a management tool that describes how GLNPO will
plan, implement, document, and assess its quality system to support its mission. The document also
communicates the policy and provides guidance on GLNPO's quality management system to all
personnel associated with GLNPO. The document has been submitted to GLNPO management and
OEI's Quality Staff for review and approval.
Program management is responsible for ensuring that the QMP is implemented. In accordance
with policies and procedures established under EPA Order 5360.1 A2 Section 7-b., Program Office
Directors and Senior Managers shall:
(1) ensure that all Program components and programs comply fully with the requirements of the
Order;
(2) ensure that quality management is an identified activity with associated resources adequate
to accomplish its program goals and is implemented as prescribed in the organizations
approved QMP;
(3) ensure that the environmental data form environmental programs delegated to State, local,
and Tribal governments are of sufficient quantity and adequate quality for their intended use
and are used consistent with such intentions;
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(4) ensure that training is available for State, local, and Tribal governments performing
environmental programs for EPA in the fundamental concepts and practices of quality
management and QA and QC activities that they may be expected by EPA to perform;
(5) perform periodic assessments of Regional organizations conducting environmental programs
to determine the conformance of their mandatory quality system to their approved QMPs and
the effectiveness of their implementations;
(6) ensure that deficiencies highlighted in the assessments are appropriately addressed;
(7) identify QA and QC training needs for all levels of management and staff and provide for
this training; and
(8) ensure that performance plans for supervisors, senior manager, and appropriate staff contain
critical elements that are commensurate with the quality management responsibilities
assigned by this Order and the organizations QMP.
This QMP documents GLNPO's quality system to meet these requirements in fulfilling its
mission. The QMP is organized in the following ten sections:
*• Section 1 continues with a description of GLNPO's program, mission, organizational structure, and
roles and responsibilities of GLNPO management and staff;
*• Section 2 describes the components of GLNPO's quality system, including a description of the tools
used by GLNPO staff to implement the quality system;
*• Section 3 provides information regarding personnel qualifications and quality system training
requirements;
*• Section 4 discusses GLNPO's process for procuring items and services and ensuring suppliers
provide items and services that are of known and documented quality and meet associated technical
requirements;
*• Section 5 provides information on the control and maintenance of documents and records;
*• Section 6 discusses GLNPO's process for managing information, including a description of
computer hardware and software administration;
*• Section 7 discusses GLNPO's process for planning environmental projects, including a step-by-step
list of questions that project planners can implement during initial stages;
*• Section 8 discusses GLNPO's implementation of work processes;
*• Section 9 provides a description of GLNPO's policies and procedures for assessing environmental
information collection activities and responding to assessment findings; and
*• Section 10 discusses GLNPO's ongoing activities towards improving quality throughout the
program.
A list of references is included at the end of the document that provides detailed information
regarding EPA OEI reference and guidance documents. A number of appendices also are included in the
QMP to further communicate GLNPO's quality system to OEI and GLNPO staff and to provide
assistance to GLNPO staff and associated agencies and organizations in implementing GLNPO's quality
system. For example, Appendix K provides examples of GLNPO's graded approaches to quality system
documentation including a quality assurance project plan (QAPP) for a project using secondary data,
Great Lakes Sediment Data Support, and Appendix L contains a checklist for determining whether peer
review is needed for a given environmental information collection and assessment activity (EICAA).
In accordance with the guidance provided in EPA Manual 5360 Al, this QMP is a dynamic
document that is subject to change as GLNPO's program progresses. A QMP should represent current
activities. This QMP is reviewed annually by the GLNPO Quality Manager to determine if revision is
required. In addition, as GLNPO's program progresses in accordance with the continuous improvement
philosophy consistent with ISO 9001 (ISO 9001:2000, Quality Management Systems-Requirements,
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2000), all changes to procedures described in this QMP will be reviewed by the GLNPO Quality
Manager to determine if the changes significantly impact the quality objectives of the program. If
changes are deemed to be significant, the QMP will be revised accordingly and distributed to the Great
Lakes National Program Manager; GLNPO's Director, Branch Chiefs, and Document Control
Coordinator; and OEFs Quality Staff.
In accordance with GLNPO's document control procedures, GLNPO's Quality Manager and
document control coordinator will maintain controlled copies of this QMP in blue binders (Section 5).
These controlled copies will be distributed to GLNPO's Director, Branch Chiefs, and OEI's Quality
Staff. GLNPO managers and staff are instructed to locate electronic copies of the QMP on GLNPO's
LAN (G:USER/SHARE/ALL/QA/GLNPO QMP/QMP 02) and in hard-copies by obtaining a controlled
copy from the Document Control Coordinator.
1.2 QUALITY MANAGEMENT POLICY, GOALS, AND OBJECTIVES
GLNPO's quality management policy focuses on four operating principles: assistance,
flexibility, value-added, and continuous
improvement. GLNPO's quality staff provide
assistance to Project Officers (POs) and
GLNPO focuses on continuous improvement
The integrity of the quality management
system is maintained when changes to the
quality management system are planned and
implemented.
planners with quality tools necessary to
implement their programs. The quality
program is flexible with the policy that all QA
policies and requirements should provide added
value to environmental information collection
and assessment activities (EICAAs). GLNPO
strives for continuous improvement by
constantly evaluating the system to identify problem areas, potential issues of concern, and areas for
improvement and then developing and implementing corrective actions to address them. The primary
goals and objectives of GLNPO's quality system are implementing projects that are based on sound
science and provide information of adequate quality to support the underlying decision. Providing cost
effective environmental programs to the taxpayer also is an overarching goal of the quality program.
GLNPO is committed to the protection of the Great Lakes system. To accomplish this, a myriad
of decisions must be made on the quality of the environment and the health of humans and wildlife.
These decisions usually depend on qualitative and quantitative measurements derived from various
EICAAs. Decision makers must be able to use these measurements with some level of confidence in
order to make informed decisions. It is the policy of the Great Lakes National Program Office to
ensure collected information is of adequate quality for the intended use. This overarching quality
management policy is implemented through a series of policies and practices that are described below.
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Allocation of appropriate
resources
Inclusion of quality
management in daily
activities
Systematic planning
Quality system documentation
Policies and Practices
GLNPO management will allocate adequate resources to meet the
quality system goals and requirements outlined in this QMP for all
EICAAs.
It is GLNPO policy that the quality system must be implemented in
daily activities of GLNPO staff. This policy is fostered through
training of all GLNPO staff on the quality system philosophy,
requirements, tools, and reference documents. In addition, GLNPO's
Quality Manager is involved in a supporting role at the project level in
many GLNPO-funded EICAA's. GLNPO policy stresses
management's responsibility to create an environment in which all
personnel contribute to producing high quality products.
It is GLNPO policy that quality can be achieved only through
systematic planning, assessment, and corrective action. Every program
supported by GLNPO funds should have clear objectives and a
detailed plan to meet these objectives. This is accomplished by
employing a thorough systematic planning process at the initiation of
any EICAA.
It is GLNPO policy that appropriate quality system documentation
(such as QAPPs) will be developed for any project which includes
EICAAs.
Provision of quality training
GLNPO's quality policy involves training POs and staff on the quality
system requirements, available quality implementation tools, and
reference and guidance documents to assist them in implementing their
programs while meeting GLNPO quality goals and complying with
GLNPO's quality system.
EPA recognizes that a "one size fits all" approach to quality requirements will not work due to
the variety of projects conducted by EPA and funded entities. Therefore, the implementation of the EPA
quality system is based on a graded approach. In accordance with EPA's quality system, GLNPO
employs a graded approach philosophy throughout all quality system activities. Applying a graded
approach means that quality systems for different organizations and programs vary according to the
specific objectives and needs of the organization. A graded approach also is applied to quality system
documentation.
The level of
effort needed to
develop and
document a
quality system
SLNPO's Quality System Requirements are commensurate with:
*• Importance of Work
>• Availability of resources
>• Unique needs of organization
>• Consequences of potential decision errors
should be based
on the scope of
the program and
the nature of the
decision. Similarly, the level of detail for quality documentation of specific projects varies according to
the complexity of the work being performed and the intended use of the data. Examples of this
philosophy are discussed in this QMP.
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As mentioned above, GLNPO employs a graded approach to documentation. The Quality
Manager, in conjunction with Project Officers, will determine the appropriate level of quality system
documentation for each project. In the past, GLNPO has used a four-tiered project category approach
(Simes 1989) to determine the detail necessary for QAPPs. These categories have been replaced by the
following categories:
»• Existing data/Modeling *• Habitat/Ecosystem restoration
»• Tribal grants *• Ambient monitoring and research
*• Sediment assessment demonstration
*• Consortium grants *• Pollution prevention and Environmental
*• Cluster grants education
*• Volunteer monitoring *• Repeating projects of similar scope
*• State Agencies
This QMP encompasses environmental information collection and assessment activities for
which GLNPO has lead responsibility, including any contracting and assistance agreements requiring
GLNPO funds. However, many agencies (Army Corps of Engineers, Department of Energy, United
States Geological Survey, EPA Regions, etc.) and state and private organizations (The Nature
Conservancy, The International Joint Commission, The Great Lakes Commission, etc.) cooperate with
GLNPO on multiple and recurring projects. In cases where GLNPO is participating in projects which are
not the direct responsibility of GLNPO, GLNPO personnel will adhere to the approved quality systems of
the lead agency, if consistent with EPA Order 5360.1 A2; otherwise personnel will adhere to GLNPO's
quality policy.
1.3 PROGRAM DESCRIPTION
The Great Lakes National Program Office (GLNPO) was created in 1978 to fulfill the United
States' obligation under the Great Lakes Water Quality Agreement with Canada. Since inception,
additional responsibilities for GLNPO have been defined in Section 118 of the Clean Water Act, Section
112 of the Clean Air Act Amendments, and the Great Lakes Critical Programs Act of 1990. GLNPO is a
geographically-focused office, whose mission is to lead and coordinate United States efforts to protect
and restore the Great Lakes. GLNPO's responsibilities include:
*• overseeing fulfillment of EPA's international commitments under the U.S.-Canada Great
Lakes Water Quality Agreement;
»• monitoring lake ecosystem indicators;
»• managing and providing public access to Great Lakes data;
»• helping communities address contaminated sediments in their harbors;
*• supporting local protection and restoration of important habitats;
*• promoting pollution prevention through activities and projects such as the U.S.-Canada Great
Lakes Binational Toxics Strategy and;
*• providing assistance for community-based Remedial Action Plans for Areas of Concern and
for Lakewide Management Plans.
GLNPO assists Great Lakes partners (including federal, state, tribal, local, educational, and
industry organizations) in these areas through technical assistance and coordination, as well as grants,
interagency agreements, and contracts.
GLNPO has the primary responsibility for developing policies and coordinating programs
relating to the Great Lakes which are both national and international in scope and effect. It functions as a
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principal liaison with Canadian federal and provincial governments, the International Joint Commission,
other EPA Regions, the EPA Office of International Activities, and the State Department. The Office
serves as a focal point of EPA's activities in fulfillment of the Great Lakes Water Quality Agreement. It
utilizes the coordinated efforts of contractors, grantees, Regional support staff, and other organizations to
generate necessary technical data and reports of findings.
1.3.1 MISSION
The ultimate mission of the Great Lakes National Program Office is to promote the protection
and restoration of the chemical, physical, and biological integrity of the Great Lakes ecosystem. GLNPO
supports its mission of Great Lakes protection by working towards the following goals:
Chemical Integrity - Reduce toxic substances in the Great Lakes Basin Ecosystem, with an emphasis on
persistent bioaccumulative substances, so that all organisms are protected. Over time, these substances
will be virtually eliminated. Maintain an appropriate nutrient balance to ensure ecosystem health.
Physical Integrity - Protect and restore the physical integrity of the Great Lakes, including habitats vital
for the support of healthy and diverse communities of plants, fish, and other aquatic life and wildlife in
the Great Lakes Basin Ecosystem. Protect Great Lakes water as a regional natural resource from
diversions and exports.
Biological Integrity - Protect human and biological health. Restore and maintain stable, diverse, and
self-sustaining populations of fish and other aquatic life, wildlife, and plants in the Great Lakes Basin
Ecosystem, including controlling and eliminating pathogens and preventing the introduction and spread
of invasive species to the maximum extent possible, to protect human health, biological health, and
economic vitality.
GLNPO, in cooperation with various States, federal agencies, Tribes, and other key partners has
developed a Strategic Plan to achieve the
above three environmental goals. The Great
Lakes Strategy (Great Lakes 2002, A Plan
for the New Millennium, April 2002)
provides the agenda for Great Lakes
Ecosystem management, reducing toxic
substances, protecting and restoring
important habitats, and protecting
human/ecosystem species health. The
Strategy was developed cooperatively by the
U.S. Policy Committee, a forum of
senior-level representatives from federal, state, and tribal natural resource management/environmental
protection agencies. The US EPA Great Lakes National Program Manager (also the Region 5
Administrator) chairs this forum. The draft Strategy identifies the major basin-wide environmental
issues in the Great Lakes and establishes common goals that the agencies will work toward. It also will
help fulfill domestic responsibilities described in the U.S.-Canadian Great Lakes Water Quality
Agreement. This strategy includes a fourth goal:
Working Together - Work together as an environmental community to establish effective programs,
coordinate authorities and resources, report on progress, and hold forums for information exchange and
collective decision-making, so the Great Lakes are protected and the objectives of the Agreement are
achieved.
The basin of this international watershed
includes two nations, eight U.S. states, a
Canadian Province, over forty Tribes and First
Nations, and many local governments. Only
through a cooperative partnership can we
ensure the health of the
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1.3.1.1 ACCOMPLISHING THE MISSION
The Great Lakes Strategy identifies the major issues or challenges stakeholders face, establishes
major efforts to address these issues, and describes how stakeholders will work together. GLNPO also
has established 5 objectives that address issues specific to its role in protecting the Great Lakes
ecosystem.
5 Objectives Established By GLNPO
to Accomplish its Mission
O Integrate Monitoring and Data Interpretation- The
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1.3.1.2 SETTING GOALS TO ACCOMPLISH THE MISSION
At the beginning of each fiscal year, GLNPO staff meet to review and assess progress, identify
goals for the coming year and outline technical activities to meet those goals. These activities typically
include:
*• Assessment and mitigation of the effects of air pollution and water pollution introduced into
the Great Lakes through monitoring of water, air, biota, and sediments,
*• Assessments and mitigation of habitat loss or modification,
»• Development of environmental indicators,
*• Assessment and mitigation of invasive species,
»• Binational coordination,
*• Restoration and enhancement of degraded or lost ecological resources,
»• Evaluation of the toxicity and extent of contaminated sediments, and
*• Pollution prevention.
GLNPO collects environmental measurements in support of these activities. These
measurements typically include:
*• Sampling and analysis of organics and inorganics in sediments, water, precipitation, air, and
wildlife,
*• Abundance and concentration surveys of wildlife,
»• Toxicity testing using bioassays,
»• Testing for physical properties of sediments and water,
*• Mapping and landscape characterization techniques through remote sensing platforms,
»• Meteorological and physical parameters,
*• Surveys regarding utilization of pollution prevention tools,
*• Modeling of secondary data, and
*• Surveys of environmental education effectiveness.
1.3.2 GLNPO ACTIVITIES AND PROGRAMS
GLNPO has ongoing monitoring programs, conducts special studies to address new impacts of
concern, and is involved in several large scale cooperative studies including a lakewide pollutant
modeling study, the Lake Michigan Mass Balance Study. Several ongoing activities are summarized
below and GLNPO's base monitoring program is discussed in detail in the next section.
Great Lakes Strategy — As discussed above, the strategy is being developed cooperatively by the U.S.
Policy Committee and a forum of senior-level representatives from federal, State, and Tribal natural
resource management/environmental protection agencies. The draft strategy identifies the major
basin-wide environmental issues in the Great Lakes and establishes common goals that the agencies will
work toward.
Great Lakes Binational Toxics Strategy (GLBTS) — Signed on April 7, 1997 by the EPA
Administrator and the Canadian Minister of the Environment, the strategy has attracted a high level of
interest both nationally and internationally. The strategy targets a suite of key chemicals that have
impacted the Great Lakes for decades, including mercury, PCBs, and dioxin. The GLBTS has become
instrumental in focusing attention on the importance of eliminating persistent, bioaccumulative, toxic
substances from the environment.
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State of the Lakes Ecosystem Conference (SOLEC) — The fourth biennial SOLEC, held in October
2001, was attended by over 500 people from a wide variety of government and non-government sectors.
Objectives for SOLEC include to 1) assess the state of the Great Lakes ecosystem based on accepted
indicators; 2) strengthen environmental decision-making and management; 3) inform local
decision-makers of Great Lakes environmental issues; and 4) provide a forum for networking among all
the Great Lakes stakeholders. SOLEC has brought heightened awareness in the Great Lakes community
to several emerging issues, including habitat loss, urban sprawl, and invasive species.
Environmental Indicator Implementation — To be successfully implemented, the SOLEC indicators
(discussed above) must be supported by: 1) a commitment to each indicator by at least one stakeholder
agency or organization for data collection, analysis, and reporting; 2) coordinated monitoring programs
among the stakeholders for cost-effective data collection; and 3) timely reporting through a binational,
interactive web site. GLNPO and Environment Canada are organizing the SOLEC efforts in all three
areas, but strong cooperation and support of many other agencies and organizations is essential.
Lake Michigan Mass Balance (LMMB) — One of the most extensive studies of a lake ecosystem ever
undertaken, the LMMB study is providing important environmental information regarding toxic loadings,
transport, and bioaccumulation within the food web. The chemicals under study, PCBs, atrazine,
mercury and trans-nonachlor, present a cross-section of important contaminants in the environment. The
mathematical mass balance models, the main products of the study, will provide state-of-the-art
management scenarios/options for control of toxics in Lake Michigan. Final project results for several
components of the study are scheduled for 2001 and 2002.
Binational Consortium to Protect Great Lakes Coastal Wetlands — Over the last several years,
Great Lakes coastal wetlands have received increasing attention concerning their quantity and quality. A
consortium of Canadian and United States scientists and resource managers has been convened to
monitor the size and ecological health of Great Lakes coastal wetlands in order to guide their protection
and restoration. The tasks of consortium members over the next two years are 1) to design and validate
indicators to assess the ecological integrity of Great Lakes coastal wetlands; 2) to design an
implementable, long-term program to monitor Great Lakes coastal wetlands; and, 3) to create, and
populate, a binational database accessible to all scientists, decision-makers, and the public.
Invasive Species — In the Great Lakes Basin, over 139 non-indigenous aquatic species have become
established since the 1800s. Many of the non-indigenous species have been introduced over the last 4
decades as a result of increased shipping and international trade. Control programs cost millions of
dollars annually, and the species are a threat to the ecological and economic value of the Great Lakes.
GLNPO participates in regional, national and international efforts to prevent introductions and control
the impact of invasive species. Through its grant program, GLNPO is funding programs to investigate
control strategies, as well as basin-wide demonstrations of innovative restoration techniques.
Air Deposition — GLNPO, working with Environment Canada, operates the Integrated Atmospheric
Deposition Network (IADN), a network of 16 air monitoring stations (5 in the U.S.). The objectives of
IADN are to determine concentration trends of priority toxic chemicals, calculate atmospheric loadings
(amounts deposited to the lakes), and to supply this information to environmental managers so that
appropriate control actions can be pursued. Currently IADN monitors for organochlorine pesticides
(including DDT, dieldrin, and chlordane), PCBs, and a suite of polycyclic aromatic hydrocarbons
(PAHs). IADN is considered a model for long-term atmospheric deposition monitoring.
Contaminated Sediments — GLNPO provides technical, financial, and field support for state and tribal
partners to help solve sediment problems. Recent actions have included remediation efforts involving the
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Ottawa River in Toledo, Ohio, and the Fox River in Green Bay, Wisconsin and additional partnership
projects are targeted for the Trenton Channel and White Lake in Michigan, and the Minnesota Slip in
Duluth, Minnesota. GLNPO also is actively involved in demonstrating the use of treatment technologies
as an alternative to landfilling. GLNPO is coordinating efforts with the Army Corps of Engineers to
evaluate options for the beneficial reuse of sediments.
Remedial Action Plan Delisting Guidance — Great Lakes Areas of Concern (AOCs) were identified in
the 1987 Protocol to the Great Lakes Water Quality Agreement. To date, only one of the 43 identified
AOCs has been remediated and formally delisted through the Remedial Action Plan process. A
workgroup comprised of federal and state agency staff as well as observers from Canada, the Province of
Ontario, and the International Joint Commission (IJC) are developing a guidance document which
describes what needs to be accomplished to achieve formal delisting.
1.3.3 BASE MONITORING PROGRAM
GLNPO has primary responsibility within the US for conducting surveillance monitoring of the
offshore waters of the Great Lakes. The water quality surveys generally consist of two surveys per year:
a spring survey and a summer survey. The spring surveys are designed to collect water quality
information during unstratified (isothermal) conditions of the lake, so the survey circuit is planned to
move from warmest to coolest waters to ensure that sampling at all sites is conducted before stratification
begins. The summer surveys are designed to monitor the quality of each lake during stratified conditions.
Survey activities are conducted onboard EPA's R/VLake Guardian, a former offshore oil field
supply vessel. The ship is operated by an onsite ship operations contractor and staffed by GLNPO Chief
Scientists, contractors, and grantees. Most of the survey measurements are made onboard the ship, either
on the bridge or deck (e.g., meteorological measurements such as wind speed and direction, wave height
and direction, air temperature, etc.), by the conductivity/temperature/depth (CTD) probe attached to a
sampling device, or in the onboard laboratories (e.g., turbidity, conductivity, pH, etc.). The remaining
measurements are made by grantee and contractor staff.
GLNPO attempts to coordinate its
spring and summer survey activities with
other organizations, such as EPA Regions
2,3, and 5, who are involved in Great Lakes
research activities. The goal of this
coordination is to maximize sampling
activities aboard the R/V Lake Guardian.
GLNPO offers the vessel for special
projects to States, universities, research
institutions, agencies, and other
organizations. In these cases, GLNPO's
Quality Management Team reviews quality
system documentation, usually a QAPP or
streamlined QAPP that addresses relevant
components consistent with the graded
approach policy of GLNPO.
SLNPO's quality system tools increase the
effectiveness of its monitoring program
through:
^" documenting and implementing SOPs,
^ conducting annual training and
readiness reviews,
^ coordinating efforts among
researchers, State, and Regional
staff,
^ maintaining, distributing, and
implementing a QAPP
^ creating real-time electronic data
To support GLNPO's ongoing monitoring programs and other special studies, GLNPO has
developed a quality management system to assure environmental information used to support decisions is
of adequate quality and usability for their intended purpose.
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1.4 ORGANIZATION OF THE GREAT LAKES NATIONAL PROGRAM OFFICE
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&LNPO staff at all levels are accountable for
continuous quality improvement
GLNPO is organized into nine teams that specialize in specific areas of interest and expertise for
data gathering activities. Each team is comprised of a team leader and staff from GLNPO, and where
appropriate, other organizations within EPA
(such as Region 5, Region 2, etc). The teams
conduct projects, develop products, and
provide support to other teams, making teams
interdependent and providing for efficiencies.
A management team oversees the activities of
all other teams. Figure 1.1 represents the
GLNPO organizational structure. As illustrated, the organization is made up of a Director, Management
Advisors, Branch Chiefs, Senior Advisor, Teams, and staff. The following sections describe the
functions of the teams and various individuals. The Quality Management Team Leader, the Quality
Manager, reports directly to GLNPO's Office Director. GLNPO's Director reports to the Great Lakes
National Program Manager, who is also the Region 5 Administrator as dictated by Section 118 of the
Clean Water Act, and thus the GLNPO Director is part of Region 5 Senior Management. Therefore,
administrative services such as budget development, training, implementation of contracts and grants,
and facilities are provided through Region 5. The GLNPO management and staff share responsibility for
implementation of GLNPO's quality system.
Figure 1.1: Great Lakes National Program Office Functional Organizational Structure
Management Team
_L
Vleki Thomas
Branch Chief.
Policy Coordination
a Communications
and Management Advisor
\
I
Teams:
Pollution Prevention,
Communications fl Reporting,
and
Program Planning fi
Budgeting
Gary Gulezian
D rector
D&ve Cui.ijgill
Branch Chief.
Technical Assistance
a Analysis
and Management Adxisor
Teams:
Sediment Assessment
S Remediation,
Ecological Protection
Restoration,
and
Information Management
a Data Integration
Paul Horvatin
Branch Chief,
Monitoring Indicators
a Reporting
and Management Advisor
Louis Blume
Quality Manager
Teams:
Biuironmental Monitoring
a lnvasi¥e Species,
and
Hearth a Safety
Team:
Quality Man agement
Quality Management Authority
Management Authority
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1.4.1 GLNPO FUNCTIONAL TEAMS
In establishing teams, the following three premises apply: (1) all teams will be established to
accomplish tasks identified as Office priorities; (2) each team and its members have responsibility for
grant and contract oversight where support resources are essential to achieving team commitments; and
(3) in general, PO and grant and contract oversight roles are determined through the teams, the team
leader, and the management advisor. These teams are:
»• Management Team (MT)
*• Ecological Protection and Restoration Team (ERST)
*• Sediment Assessment and Remediation Team (SART)
»• Information Management and Data Integration Team (IMDI)
»• Environmental Monitoring and Indicators Team (EMIT)
»• Health and Safety and Environmental Compliance Team (HST)
»• Communications and Reporting Team (CRT)
*• Pollution Prevention Team (P2)
*• Program Planning and Budget Team (PBT)
*• Quality Management Team (QMT)
Each team has developed a performance agreement (except for the Management Team and Teamlets),
which includes a mission statement. Mission statements of each team are provided in Appendix B.
Team leaders are responsible for developing the performance agreements. Although team leaders
suggest and facilitate key people and functions for staff, they are not part of management and do
not have supervisory authority. However, as part of the development of performance agreements, tasks
are assigned to key staff and these tasks are finalized with management approvals of the agreements. For
this reason, it is important that Team leaders draft performance agreements that are detailed enough to
capture staff assignments. Team performance agreements do not cover all GLNPO activities such as:
Great Lakes Team activities; developing, publishing and distributing Reports to Congress; LaMP
activities; and new activities addressing areas of concern (AOCs). Annually, each team submits a
workplan and proposed resources for discussion and approval by GLNPO managers. Team activities for
the year are planned based on these approvals. Two "functional areas" also are active and in the future
may become teams. They are: Invasive Species and Emerging Issues. These functional areas coordinate
grants and contracts and prepare formal and informal reports to management.
The Quality Management Team supports GLNPO's environmental information collection and
assessment activities by providing the necessary resources and tools to assure the collection of data of
known and appropriate quality.
The Quality Management Team serves three major functions. First and foremost, the team
provides assistance to GLNPO staff and cooperators to assure that studies produce data of adequate
quality for the environmental decisions being made. Secondly, the Quality Management Team functions
in a role of independent evaluation and oversight to assure adherence to GLNPO quality policy and
protocols. Lastly, the Quality Management Team assists in developing documents or products, including
policy statements, progress reports, plans, and reports for major data collection activities.
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Table 1-1. Major Functions of the Quality Management Team
Function
Description
Provide assistance
Assist in the development of quality system documentation and identification of project quality
objectives
Provide tools (software, guidance documents, technical expertise) for the development of
quality system products. These include QA project plans, sampling designs, field and
laboratory audits, data quality assessments, and QA reports
Provide training on various quality system requirements and concepts, with special emphasis to
POs
Assist in defining appropriate project-specific quality system documentation
Provide assistance and guidance in implementing the National Peer Review Policy
Maintain a QA Library
Act as a liaison with EPA Quality Staff (monthly conference calls) for policy information
Attend national/bi-national QA meetings to keep abreast of QA improvements
Evaluation/Oversight
Review and comment on QA project plans within 10 working days of receipt by PO
Assist in implementing data quality and technical systems audits
Conduct data quality assessments
Use QATRACK as an evaluation tool for quality system documentation development (Section
2.6)
Serve as QA chair on various programs
Develop QA reports for major data collection activities
Oversee peer review program
Documentation
Revise GLNPO's QMP every five years or as needed to capture policy changes, submit QMP to
Quality Staff, and distribute to GLNPO staff
Write QA Annual Report and Workplan for EPA Quality Staff and GLNPO Staff
Prepare monthly Quality Management Team briefing reports
Maintain a database of peer review and scientific activities. Write a mid-year and annual report
Coordinate development of SOPs for ongoing monitoring projects
Maintain a database for key QA project-level documents
Assist in the development ofQA reports for efforts supporting key environmental decisions
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1.4.2 KEY PERSONNEL AND ASSOCIA TED RESPONSIBILITIES
1.4.2.1 GLNPO DIRECTOR
The Director has overall responsibility for managing GLNPO according to Agency policy and
has final authority at the program office level.
As noted in EPA Order 5360.1 A2, the direct
responsibility for assuring data quality rests
with line management. Ultimately, the
Director is responsible for establishing QA
policy and resolving QA issues which are
identified through the Quality Management
Team and Quality Staff.
SLNPO's Director fosters a seamless quality
management policy by integrating quality
activities into daily operations.
Table 1-2. Major Responsibilities of the Director
Function
Description
Management
Serves as Management Team leader
Approves the budget and planning processes
Ensures quality management policy is discussed with GLNPO management and
is addressed in individual and team performance agreements
Quality policy establishment
Ensures that GLNPO develops and maintains a current QMP and ensures
adherence to the document by GLNPO staff, other EPA offices, and extramural
cooperators funded by GLNPO
Establishes policies to ensure that quality management requirements are
incorporated in all environmental information collection activities
Ensures that appropriate quality system documentation is developed for all data
collection activities in which GLNPO is the project leader and submitted to the QA
Manager for review and approval prior to project initiation
Encourages atmosphere where quality management practices are a beneficial
and integral par of GLNPO staff daily activities
Recognizes and awards exemplary quality implementation
QA issue resolution
Maintains an active line of communication with the Quality Manager
Facilitates corrective action that may be required by the quality Manager's
findings
Ensures that the protocol to address missed requirements in GLNPO assistance
agreements (Appendix M) is implemented.
The Director delegates partial responsibility of quality management system development and
implementation in accordance to Agency policy to the Branch Chiefs, Team Leaders, and Project
Officers. Oversight of the GLNPO quality management program is delegated to the Quality Manager.
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1.4.2.2 BRANCH CHIEFS/MANAGEMENT ADVISORS
Branch Chiefs and Management Advisors oversee and support the activities of the various
GLNPO teams. These individuals serve a dual role: that of supervisor to designated GLNPO staffer
Senior Advisors, and that of Management Advisor to designated teams. Because each advisor has
specific skills, education, and work experience, advisors are a resource to all teams. The Branch Chief is
the delegated manager responsible for data collection and quality management activities of projects
occurring within their respective branch. GLNPO's director is the management advisor for the Quality
Management Team.
Table 1-3. Major Responsibilities of Branch Chiefs and Management Advisors
Function
Description
Supervision/Management
Supports the team members and assists in obtaining necessary resources
Helps select the team leaders and team members
Advocates the team cause and works to overcome barriers
Ensures that the protocol to address missed requirements in GLNPO assistance
agreements (Appendix M) is implemented.
Management of data
collection and quality
management activities
Ensures that appropriate QA criteria for all projects and tasks are included in operating
guidance forall teams in which the Senior Advisor is the Management Advisor
Ensures establishment of data quality acceptance criteria for all projects and tasks
conducted by the branch
Ensures that an adequate degree of auditing is performed to determine compliance with
quality management requirements
Ensures that deficiencies highlighted in audits are appropriately addressed
Develops quality management-related infrastructure and communications channels
Identifies project-specific quality training needs and provides for required Quality
management training
Evaluates QA/QC costs
Reviews and evaluates the quality of outputs generated by each project
Informs the GLNPO Quality Manager of all data collection activities occurring within
his/her respective branches
Ensures that all POs understand their quality management responsibilities and that quality
is addressed in the position descriptions of all subordinates involved in data collection
activities
Ensures that quality management is an identifiable activity with associated resources
adequate to accomplish program goals in the development and execution of all projects
and tasks, both intramural and extramural, involving environmentally related
measurements
Ensures that all projects and tasks involving environmentally related measurements are
covered by an appropriate quality system documentation and that the system is
implemented
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1.4.2.3 TEAM LEADERS
The Team Leader is the person who manages the team, including orchestrating all team
activities, calling and facilitating meetings, handling administrative details, and overseeing preparations
for reports and presentations. The Team Leader is responsible for preparing Team performance
agreements. Ultimately, it is the Team Leader's responsibility to identify team tasks and, through the
Supervisor, to assign tasks and provide the means to enable team members to do their work. The Team
Leader is the contact point for communication between the team and the rest of the organization,
including the management team. The Team Leader position will be periodically reviewed and changes in
leaders can occur based on recommendations from the current leader, the team, or the Management
Team.
Table 1-4. Role of the Team Leader
Function
Description
Team management
Focuses the energies of the team on defining and accomplishing desired outcomes on
projects as directed by the Management Team to accomplish an Office priority
Strengthens the team and its processes by being careful to see that all matters that
involve and affect the team are dealt with by the group, while at the same time avoiding
those items or tasks that do not concern the group. (These items are handled by
appropriate subgroups or individuals who give feedback on progress and results to the
whole team.)
Shares information on quality system documentation delinquencies (except for Safety
Team)
Prepares monthly report and annual workplan (except for Safety Team)
Considers quality system implementation in workplan and team discussions
Suggests POs to team projects
Communication contact
point
Helps the team utilize efficient communication processes that provide better information,
more technical knowledge, more facts, and more experience for decision-making
purposes
Routinely updates and briefs the Management Advisor and the Management Team on
status of projects, schedules, anticipated road blocks with proposed solutions, budget
projections, etc.
Team member
encouragement and
support
Uses group decision making at every appropriate opportunity to earn team member's
support for the final product or decision, thus gaining commitment to execute it fully
Knows that at times decisions must be made rapidly and cannot wait for group processes;
therefore, anticipates these emergencies and establishes procedures with the team for
handling them so that action can be taken rapidly with group support
Takes primary responsibility for establishing and maintaining a thoroughly supportive
atmosphere throughout the team; encourages every member to participate
Encourages discovery of alternatives and solutions by protecting team members and their
ideas from attack and criticism, so team members feel secure in sharing and exploring a
multitude of proposals, ideas, thoughts and opinions
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1.4.2.4 TEAM MEMBERS
Although one person in the team will have the formal responsibility of being the Team Leader,
each team member shares in the responsibility to accomplish the goals of the team. Whenever a team
comes together to trade information, develop strategies, solve problems, or make decisions, every
member of the team must share the responsibility for making the meeting as successful as possible. In
addition, all GLNPO team members and GLNPO staff are responsible for implementing GLNPO's
quality system.
Table 1-5. Responsibilities of Team Members
Function
Description
Accomplishing the goals and purpose
of the team
Team members will consider their participation as a priority responsibility, not
an intrusion on their real jobs
Team members are responsible for contributing fully to the project as possible,
sharing their knowledge and expertise, participating in all team meetings and
discussions, even on topics that may be outside their area
Team mem bers will carry out their assignments between meetings
An individual may be needed as a team member if they:
*• Possess critical information, knowledge, or expertise pertinent to the subject or project
under consideration;
*• Have a stake in the final outcome. That is, this individual will be directly impacted by what
is decided, and his/ her commitment is required for successful implementation;
*• Have responsibility for implementing the project;
*• Possess contrary viewpoints that will stimulate discussion, produce critical thinking, and
moves the group forward in its thought process; and
*• Need to be a team member because of his or her position in the management structure of
the Office.
1.4.2.5 QUALITY MANAGER
The Quality Manager is the delegated manager of the GLNPO quality management program.
The main responsibilities of the Quality Manager are overseeing all quality management tasks, ensuring
that all personnel understand GLNPO's quality management policy and requirements and that all
personnel understand their specific quality management responsibilities. The Quality Manager provides
technical support to plan, implement, document, and assess the effectiveness of QA and QC activities
associated with GLNPO-funded EICAA's. To facilitate this role, the Quality Manager reviews and
approves all quality management products.
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Table 1-6. Responsibilities of the Quality Manager
Function
Description
Oversight and management
Interprets Agency quality policy and develops the QA policy for GLNPO in
accordance with Agency quality management policies and direction from
management
As a quality management advisor, reviews all acquisition packages (grants,
cooperative agreements, inter-agency agreements) to determine the necessary
QA requirements (the Quality Manager's approval signature is required on all
grant acquisition packages to evaluate whether environmental data is collected or
used)
Develops quality management budgets
Ensures that all laboratory, field, or office personnel involved in environmental
information collection have access to any training orQA information needed to be
knowledgeable in QA requirements and protocols
Ensures that audits/reviews are accomplished to assure adherence to approved
quality system documentation and to identify deficiencies in QA/QC systems
Ensures that adequate follow-through actions are implemented in response to
audit/review findings
Tracks the status of all quality system documentation
Identifies problems and advises on required management-level corrective actions
to Director and Management Team
Serves as the program's liaison with Quality Staff
Implements peer review component of quality system
Provision of technical support
Assists staff scientists and project managers in developing quality system
documentation and in providing answers to technical questions
Ensures that all environmental information collection activities are covered by
appropriate quality system documentation (e.g., QAPPs)
Ensures that sampling and analytical methods for routine operations are well-
documented through Standard Operating Procedures (SOPs)
Assists in determining for each project, the need for, type, and frequency of
performance evaluation and reference samples.
Assists in solving QA-related problems at the lowest possible organizational level
Development, review and approval
of QA products
Develops a QMP and revises it as necessary
Develops a QA Annual Report and Workplan for the GLNPO Director and the
Agency's Quality Staff
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SLNPO's Quality Management Team provides
"tailor-made" support to assist the Project
Officer in implementing appropriate quality
system activities.
The Project Officer (PO) has ultimate
responsibility for ensuring GLNPO's quality
policy is implemented for all EICAAs under
their primary direction. The PO, in consultation
with the Quality Management Team, determines
the quality system requirements and criteria for
scheduled projects based on the intended use of
the data. The PO has the responsibility for
ensuring that these quality system activities are
communicated in the project-specific quality system documentation (e.g. QAPPs). The PO is the key
Agency spokesman for the grantee regarding implementation of the quality system. The PO is the
principal technical contact for the Agency regarding extramural investments. In general, the PO is the
only person who can evaluate the technical content of requested products and accept or reject these
products.
Table 1-7. Responsibilities of the Project Officer
Function
Description
Coordination of specific project(s)
and determination of QA criteria
Develops or assists in the development of project quality objectives
Ensures the submission, review, and approval of appropriate quality system
documentation (e.g., QAPP) prior to information collection
Ensures the implementation of approved quality system documentation for the
project
Ensures that standard operating procedures (SOPs) for each data collection
operation are reviewed and approved
Implements systematic planning for all environmental information collection
activities
Reviews project products for adherence to QA goals
Adheres to Agency peer review policy
Alerts management and Quality Management Team when a grantee or contractor is
not producing acceptable deliverables
Arranges for performance evaluation samples or reference samples (when
applicable) in consultation with the quality manager
Arranges and conducting audits
Ensures that required corrective actions are implemented
Reports data quality problems to the Quality Manager.
Reviews the quality system documentation with project staff, and for extramural
projects, with extramural organization's QA representative and principal investigator
Ensures that the protocol to address missed requirements in GLNPO assistance
agreements (Appendix M) is implemented.
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In some cases, GLNPO will fund programs in other EPA Regions and a Project Officer will be
identified from Region staff. This individual will be responsible for the quality management activities
listed above as required in the Region's QMP. However, the GLNPO Quality Manager and other staff
will have an opportunity to review quality management material as defined in Section 1.2
1.4.2.7 PRINCIPAL INVESTIGATOR
The principal investigator (both intramural and extramural) is responsible for adhering to
guidance and protocol specified in the quality system documentation when carrying out tasks for
GLNPO-funded EICAAs.
Table 1-8. Responsibilities of the Principal Investigator
Function
Description
Adherence to quality system
documentation
Prepares quality system documentation, in accordance with EPA Order 5630.1 A2 and
grant specifications, and submits it to GLNPO PO for review and approval prior to
information collection activities
Negotiates data quality requirements with the PO and appropriate QA representatives
Trains staff in the requirements of the quality system documentation and in the
evaluation of QC measurements
Develops standard operating procedures (SOPs) and implements good laboratory
practices
Verifies that all required quality management activities were performed and that
measurement quality standards were met as required in the quality system
documentation
Follows all manufacturer's specifications for utilized instrumentation
Performs and documents preventative maintenance
Documents deviations from established procedures and methods
Reports all problems and corrective actions to the PO
Prepares quarterly reports and final project report in addition to other deliverable
requirements in the grant/contract
1.5 WORKING WITH EPA REGIONS AND STATES
In implementing EICAA's to achieve its mission, GLNPO works cooperatively with EPA
Regions 2, 3, and 5, as well as eight Great Lakes States (Pennsylvania, New York, Ohio, Indiana,
Michigan, Illinois, Minnesota, and Wisconsin). The Regions, as well as some of the Great Lakes States,
have developed and implemented quality systems specific to their EICAAs. Implementation of the
quality systems may not be similar; however, comparability of data collected from each organization is of
prime importance. Before cooperative projects are implemented, Regions, States, and programs
participating in the project will have an opportunity to review quality system documentation. The PO has
the responsibility of reviewing the quality system documentation from a technical perspective. GLNPO
will distribute this QMP to Regions with which it frequently cooperates for review and comment.
GLNPO also will review quality system documentation from the respective Regions, States, and other
organizations to gain an understanding of their quality policy requirements.
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GLNPO will work with States to develop and implement an approved quality system through
review and approval of a quality management plan. If a State has a GLNPO-approved quality system,
then GLNPO will assist the State with review of quality system documentation but will defer to the State
for approval of the documentation. To date, Wisconsin is the only state to develop a GLNPO-approved
QMP; however, additional states are in the process of developing QMPs.
1.6 HISTORY OF QUALITY MANAGEMENT AT GLNPO AND ORGANIZATIONAL
ACCEPTANCE
GLNPO initiated an independent quality management program in 1992, previously operating
under the Region 5 QA Program. Since 1992, GLNPO's program has matured and now governs a wide
variety of environmental information collection activities. Currently, for all base monitoring program
activities that derive key environmental data for the Government Performance and Results Act (GPRA),
GLNPO has established sampling and analytical protocols that are documented in a retrievable and
publicly-available format. GLNPO also has developed a database that includes a common data
dictionary and sufficient management controls that provide for data collection storage and reporting. In
aggregate, GLNPO's quality system provides for ensuring quality data collection for decisions based in
sound science.
GLNPO's efforts over the next five years will emphasize maintaining the current program, as
documented in this QMP, as well as institutionalizing the use of our data systems and standards. Further,
GLNPO hopes to work with the many external stakeholders implementing the new Agency QA Order
which is consistent with the International Standard 9000 (2000), that provides for all our partners to
implement consistent quality management systems.
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Section 2
Quality System Components
GLNPO must implement a quality management program that provides the management and
technical practices to ensure that environmental information used to support Agency decisions are of
adequate quality and usability for their intended purpose. GLNPO uses a wide variety of quality
management practices and tools to implement its quality system including:
^" quality management plans,
^" project quality obj ectives and systematic planning,
^" quality system documentation,
>- standard operating procedures,
>- training,
>- tracking EICAAs,
^" quality management team monthly reports to management,
>- Director review of quality system implementation at the branch level, and
^" GLNPO's annual report and workplan.
2.1 QUALITY MANAGEMENT PLANS
This QMP serves to document GLNPO's quality system and also to communicate the quality
system to all GLNPO staff. The QMP is developed for use by all GLNPO staff, as detailed in Section 1.
This QMP is approved by the GLNPO Director, Branch Chiefs, Team Leaders, and a Quality Staff
representative. Staff also will be encouraged to use the QMP as a reference in support of EICAA's.
When funding EICAA's through States, Regions, or other organizations, GLNPO may require
development of a QMP for important or long-term projects that support a critical environmental decision.
2.2 PROJECT QUALITY OBJECTIVES AND SYSTEMATIC PLANNING
A crucial component of GLNPO's quality system is up-front systematic planning. Although
projects vary greatly in scope and importance, each should be started in essentially the same way —by
determining the level of quality required and by planning accordingly. Consistent with GLNPO's graded
approach, the level of quality required will be determined by evaluating the importance of the activity,
available resources, the unique needs of the organization, and the consequences of potential decision
errors. A systematic planning process is used to facilitate the planning of data collection activities. It
asks the data user to focus their planning efforts by specifying: 1) the use of the data (the decision), 2) the
decision criteria, and 3) an acceptable probability threshold for making an incorrect decision based on the
data. The process should:
*• establish a common language to be shared by decision makers, technical personnel, and statisticians
in their discussion of program objectives and data quality;
*• provide a mechanism to pare down a multitude of objectives into major critical questions;
*• facilitate the development of clear statements of program objectives and constraints which will
optimize data collection plans; and
*• provide a logical structure within which an iterative process of guidance, design, and feedback may
be accomplished efficiently and cost effectively.
Systematic planning must be a normal part of the project planning process and must be
accomplished based on cost-effectiveness and realistic capabilities of the measurement process. A
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detailed step-by-step process for planning is included in Section 7, that can be used to assist POs and
planners with planning effective EICAAs and complying with GLNPO's systematic planning
requirements.
One approach that can be used for systematic planning is the Data Quality Objective process as
described in EPA's document Guidance for the Data Quality Objective Process, EPA QA/G-4, August
2000. Generally, the data quality objectives (DQOs) are statements of the overall maximum uncertainty
associated with the measurement system and the population that the data users are willing to accept in the
results derived from the EICAA. It is the responsibility of the GLNPO PO to define this allowable
uncertainty and develop DQOs with the principal investigators and cooperators. When a formal DQO
document is required, it will be reviewed and approved by the Quality Manager and the Branch Chief.
Training software on the DQO process also can be acquired from Quality Staff: Decision Errors
Feasibility Trials (DEFT) is an updated version of earlier software that assists in the implementation of
the DQO process.
A formal systematic planning document must be prepared for EICAAs that meet any of the
following criteria:
• EICAAs in support of EPA regulations or enforcement;
• Long term monitoring programs at numerous sites throughout the Great Lakes and surrounding
basin;
• EICAAs that provide a basis for significant environmental decisions (relative to the importance
of the decision);
• EICAAs longer than two years; and
• Any EICAA for which the Director deems it necessary.
Other projects that do not meet these criteria will require less formal documentation and should
include the following information:
• definition of the objectives of the study and why environmental data are needed;
• definition of the quality of the data needed in order to meet the objectives (acceptable
uncertainty);
• time and resource constraints of the project and how it affects data quality;
• identification of the possible errors that may arise during the data collection process; and
• the calculations, statistical or otherwise, that will be performed on the data in order to arrive at a
result.
A systematic planning process assists the user in defining the purpose for the EICAA and sets the
framework for the design, implementation, and quality management of the project. Once project quality
objectives are defined, a quality management program can be developed. Quality system documentation
detailing this quality management program is then created which describes all the activities specifically
designed for controlling and evaluating the data in order to satisfy the project objectives.
2.3 QUALITY SYSTEM DOCUMENTATION
The EPA quality policy requires every EICAA to have written and approved quality system
documentation (e.g., QAPPs) prior to the start of the EICAA. This policy and the information included
in this section applies equally to intramural and extramural quality system documentation. The purpose
of the documentation is to specify the policies, organization, objectives, and the quality assurance
activities needed to achieve the project objectives of an EICAA. It is the responsibility of the PO to
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adhere to this policy. GLNPO employs a checklist that can be used by the PO and the Quality Manger to
determine if formal quality system documentation is necessary for a given project (Appendix F). If the
PO proceeds without approved quality system documentation, they are fully aware of the risks and
assumes all responsibility. This risk should only be taken in extreme emergencies. The PO also bears
the responsibility of providing copies of the approved quality system documentation to each individual
who has a major responsibility in the EICAA and explaining the elements of the quality system
documentation to these individuals.
If a Quality Assurance Project Plan (QAPP) is deemed to be required by the PO and Quality
Manager, QAPPs are prepared, reviewed, and approved in accordance with EPA QA/R-5, EPA
Requirements for Quality Assurance Project Plans (Appendix G). This document identifies and defines
the 24 elements that must be addressed in all formal QAPPs. For some EICAAs, only a subset of the 24
elements may be applicable and according to GLNPO's graded approaches, GLNPO only requires that
applicable elements are addressed in quality system documentation. These graded approaches are further
discussed in Section 2.3.1.
Review of the quality system documentation must include principal investigators, the PO, and the
Quality Manager. It is recommended that the document be reviewed by the PO before submission to the
Branch Chief and Quality Manager. The Quality Manager will review quality system documentation for
the required elements, the soundness of the quality assurance activities, and compliance with GLNPO's
quality system. The Quality Manager will provide written comments on each element, which will be
accompanied by a QAPP or QMP checksheet (Appendix J). The checksheet is a summary that alerts the
PO as to whether or not QA requirements have been adequately described. The Quality Manager will
attempt to review quality system documentation within 10 working days of submission.
All quality system documentation should be filed with the GLNPO Document Control
Coordinator (DCC), who will identify the document with a unique document control number (see section
5). At present, this will be accomplished manually, however, an automated system is planned. All
original copies of the quality system documentation will be secured by the DCC. The Quality Manager
will maintain a hard- and soft-copy of the QM review for the quality management files. Tracking of
quality system documentation will be accomplished by the GLNPO Quality Manager utilizing
"QATRACK" a database system described in Section 2.6.
2.3.1 GLNPO's GRADED APPROACHES TO QUALITY SYSTEM DOCUMENTATION
All EICAAs conducted by GLNPO staff (including Federal or private employees retained for
GLNPO services and located at the GLNPO offices) must be covered by appropriate quality system
documentation prior to the start of the EICAA. In the past, GLNPO has used a four-tiered project
category approach to its quality management program in order to effectively focus quality management
activities. This approach was developed by the U.S. EPA, Risk Reduction Engineering Laboratory,
Cincinnati, Ohio (EPA/600/9-89/087). As stated in this year's QAARWP, GLNPO is no longer using
these categories for development and review of QAPPs. However, for historical clarification, GLNPO's
base monitoring program falls under Category 2 and a QAPP meeting these requirements is being
implemented in support of that program. Guidelines for each of these categories can be found in EPA
document EPA/600/9-89/087.
Every expenditure that GLNPO makes towards EICAAs, and every intramural project that
collects environmental information driven by environmental decisions should have some documentation
commensurate with the importance of the question that is being addressed. GLNPO's graded approaches
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for quality system documentation for secondary data, modeling, consortium grants, habitat/ecosystem
restoration, and sediment assessment are discussed in Section 7.2.1 and examples are included in
Appendix K.
2.4 STANDARD OPERATING PROCEDURES
Good laboratory practices and good management of field sampling operations include the
development and use of standard operating procedures (SOPs) for all routinely used sampling,
preparation and analytical laboratory methods, and the housekeeping that supports them. SOPs facilitate
comparability of data generated at different times, or by different field or laboratory staff. These
protocols should be detailed enough so that someone else can reproduce results using the SOP (i.e., a
journal article is usually not sufficient).
GLNPO will use SOPs to reduce variability in processes that are performed repeatedly by
multiple staff. During the planning phase of any EICAA, GLNPO will identify tasks that will be
performed routinely or by multiple staff, and will develop procedures for performing these tasks. SOPs
are written by the individuals performing the procedure and are reviewed by one or more individuals with
appropriate training and experience with the process. The SOPs not only serve to ensure that routine
tasks are performed correctly and consistently, but also provide the basis for staff training programs. The
GLNPO Quality Manager will review and audit staff conformance to SOPs and make recommendations
for updating these procedures annually. The POs in conjunction with the Quality Manager will work
with the principal investigators and quality staff from their organization to identify the procedures that
would benefit from the use of SOPs. This approach for developing and approving SOPs for use in new
and ongoing projects provides GLNPO with the following benefits:
*• consistency in performance, particularly in conducting data review and validation tasks;
*• improved data comparability, credibility, and defensibility;
*• reduced errors; and
*• increased efficiency in performing tasks, thus lowering costs.
In 2000, GLNPO developed a comprehensive manual titled, Sampling and Analytical Procedures
for GLNPO's Water Quality Survey of the Great Lakes. GLNPO reviews all SOPs in the manual for
improvement and clarity during performance of the WQS and will develop new SOPs for appropriate
activities. This manual will be updated yearly using appropriate document control procedures to
incorporate improvements and clarifications identified during the survey. A controlled copy of this
document is maintained by GLNPO to ensure that all individuals participating in the survey have and
employ current SOPs (Section 5).
Recommended Elements of an Analytical SOP
•• Scope and Application
•• Method Summary
•• Sample Handling and Preservation
•• Interferences
•• Safety
•• Equipment/Materials/Reagents
•• Calibration
•• Procedure
•• Calculations
QA/QC
•• References
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The elements listed above are recommended but will not be strictly enforced due to the fact that
methods may be used that have been previously documented. However, long-term programs should
contain SOPs that include these elements, presented in a form that is useful to anyone performing the
method.
Methods can be included in the quality system documentation either in the body of the document
or as an appendix. If the referenced method is not followed precisely, addendums to the method must be
included in the documentation that clearly identifies changes to the method, such that changes are
obvious to any individual using the method. If this altered method is used for an extended period of time,
the full method must be revised and submitted. A method cannot be revised during project
implementation without the prior consent of the PO. If the modification is accepted, it must be
documented in a letter to the PO and included in the next submitted report. It is the responsibility of the
PO to inform all relevant project participants of the protocol change.
Laboratories working with GLNPO should have a good laboratory practices document that is
available for review during technical audits. GLPs refer to the general practices that relate to the
majority of measurements such as: facility and equipment maintenance, record keeping,
chain-of-custody, reagent control, glassware cleaning, and general safety.
2.5 TRAINING
In order to facilitate staff awareness of the quality system, all GLNPO staff involved in EICAAs
will receive a training course on the quality system based on this QMP. As part of the training, staff will
be given an overview of the contents of this QMP and the location, electronically and hard-copy, of the
current QMP. Staff also will be encouraged to use the QMP as a reference in support of EICAA's.
Management personnel receive additional training on their specific roles and responsibilities for
implementing GLNPO's quality system. GLNPO's quality management staff receive additional training
on quality planning, documentation, and assessment. Section 3 provides detailed information regarding
GLNPO's training requirements for quality management.
2.6 TRACKING ENVIRONMENTAL INFORMATION COLLECTION ACTIVITIES
Due to the number of assistance agreements funded each year, GLNPO developed and employs a
database system (QATRACK) to track the development, review, and approval of quality system
documentation for all EICAA's involving GLNPO funds. The database assists GLNPO with ensuring
that all grants and contracts have the required quality system documentation as determined by the Quality
Manager and PO. Because quality system documentation must be approved prior to initiation of an
EICAA, the Quality Manager is part of the assistance agreement signature chain (see Appendices H and
I), allowing for the earliest possible tracking of the agreement. Data are entered into QATRACK during
the assistance agreement start-up stage, upon review and signature approval of the agreement by the
Quality Manager. QATRACK has the capability to capture multiple rounds of submissions and reviews
of the quality system documentation.
The QATRACK database also is used to prepare reports on the status of quality system
documentation for ongoing EICAAs. GLNPO's Quality Management Team uses the database to assist
them in preparing reports to management that provide the number of ongoing EICAAs and the status of
required quality system documentation. The database was designed also to function as a management
tool for evaluating adherence to the quality system and staff workload distribution. QATRACK is a
Microsoft Access-based application with one version available for the Quality Manager for entry, editing
and archive, and a second version available to staff which is "write protected" for review and query.
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GLNPO is in the process of developing a version of this system in Oracle, GLNPO's Project Tracking
Database (PTD) and hopes to implement the system in the last quarter of FY 2002. When implemented,
information for new projects will be entered into the PTD and information for past projects will be rolled
over into the new database as time allows. The database will be organized according to nine tabs as
follows:
Tab 1: General Project Information
- GLNPO ID # (alpha-numeric)
*• Funding Mechanism (grant, interagency agreement, cooperative agreement, contract, in-house,
procurement request)
*• Assistance Agreement #
»• Contract #
*• Solicitation Type (text)
*• DCN # (alpha-numeric)
*• Title of Project (text)
*• Project Summary/Description (text)
*• Project Type (research or demonstration; survey, study, or investigation; other)
*• PI Information (name, address, phone, fax, email, organization name, organizational type [checklist:
State; Interstate Agency or Commission; Sub-state or special purpose district; County; Municipality;
Federal Agency; College or University; Tribal Organization; Federally funded research and
development center; Individual; For-profit Company; or Other])
*• PO Information (name, phone)
*• Category (contaminated sediments, ecological protection and restoration, pollution prevention and
reduction, monitoring, indicator development, invasive species, strategic or emerging issues, LaMP,
GLWQA, GPRA, other)
*• Lake basin (Ontario, Erie, St. Clair, Huron, Michigan, Superior, Connecting Channels, AOCs [list all
out] All, Other)
- State/province where project is located (NY, PA, OH, MI, IN, IL, WI, MN, Ontario, All, Other)
*• Congressional district (text)
*• Project Location (text)
*• Project period start (date)
*• Project period end (date)
»• Amendment start date(s)
»• Amendment end date(s)
»• Amendments (open)
»• Award date
*• QA needed (yes or no)
*• Peer review needed (yes or no)
- Data to GLENDA (yes or no)
*• Keyword (text)
*• Comments (open field)
Tab 2: Grant, Cooperative Agreement, Interagency Agreement Pre-Award Phase
- GLNPO ID #
*• Funded? (Yes/no)
»• Amount requested (money)
»• Amount match (money)
»• Preproposal (open field to attach document)
»• Technical screening (checkbox)
»• Lake team recommendations (checkbox)
»• Recommendations to management (checkbox)
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»• Management decision (checkbox)
»• Date of Management decision
»• Comments (open field)
Tab 3: Grant, Cooperative Agreement, Interagencv Agreement Award Phase
- GLNPO ID #
»• Grant specialist name and phone
*• Budget period start (date)
*• Budget period end (date)
»• Fiscal year
»• Amount obligated (money)
»• Amount matched (money)
*• Congressional earmark? (Yes/no)
»• Date of full proposal request letter
*• Date full proposal received
*• Date documents/checklist come from assistance section
*• Date commitment notice sent (GLNPO)
*• Date of decision memo
*• Date final documents come from assistance section
*• Date assistance agreement to NPM
*• Comments (open field)
Tab 4: Grant, Cooperative Agreement, Interagency Agreement Project Management Phase
- GLNPO ID #
»• Progress report frequency (open)
*• Site visits (date) (be able to enter in multiple dates)
*• Site visit report (open field) (be able to enter in multiple reports)
»• Program requirements checklist (progress report, draft of final report, final report, project
documentation, payment, meetings/conferences, subcontracting, quality assurance, locational
information, data reporting, safety manual, signage, disposition of wastes, other)
»• Date progress reports due
*• Date progress reports received
*• Progress reports (open field)
*• Date receive QA plan
*• Unliquidated obligations (open field)
*• Unliquidated obligations dates
*• Date of financial status report
*• Financial status report (checkbox)
*• Comments (open field)
*• Reminder e-mail sent (checkbox)
*• Recipient contacted (checkbox)
»• Demand letter sent (checkbox)
»• Delinquency notice sent (checkbox)
»• Letter sent to branch chief (checkbox)
»• Letter sent to grantee from BC (checkbox)
*• Teleconference (checkbox)
*• Suspension letter sent from BC (checkbox)
»• Meeting to discuss options (checkbox)
»• Comments (open)
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Tab 5: Grant. Cooperative Agreement. Interagency Agreement Project Closeout Phase
- GLNPO#
*• Final document checklist (MBE/WBE, property, inventions, final FSR)
*• Money expended
*• Final report received (yes/no)
*• Final report approved (yes/no)
*• Final report (open field)
*• Final report location (eg.: web address)
*• Date closed-out
*• Comments (open field)
*• Reminder letter from assistance (check mark)
*• Contact recipient prior to due date (check mark)
*• Recipient contacted on due date (check mark)
*• Demand letter sent (checkmark)
*• Teleconference (check mark)
*• Delinquency notice sent (check mark)
*• Letter sent to branch chief (check mark)
*• Letter to grantee from director (check mark)
*• Teleconference (check mark)
*• Suspension letter sent to grantee (check mark)
*• Teleconference (check mark)
*• Debarment and suspension call and letter sent (check mark)
»• Comments (open)
Tab 6: Contracts
- GLNPO ID #
*• Statement of work/Specifications (open field)
*• Contract specialist name and phone
*• Contract officer name and phone
*• Contracting Officers Representative Training (yes or no)
*• Contracting Officers Representative Training Form (open)
*• Work assignment/Task order (open)
*• Work assignment # / Task order #
*• Work assignment/Task order Start Date
*• Work assignment/Task order End Date
*• Work plan (open)
*• Technical Directive (text)
*• Technical Directive (date)
*• Procurement Request (open)
•• Date of procurement requisition
*• Procurement requisition amount ($)
•• Committed amount ($)
- Amount ($)
»• Date of commitment
- DCN#(text)
•• Comments (open)
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Tab 7: Communications
- GLNPO ID #
»• Final report submitted to GLNPO? (yes/no)
*• Web information (open)
»• Press release (open)
»• Fact sheet (open)
*• Journal article publication (open)
*• Outreach/Tech transfer planned (open)
*• Slides (open)
»• Comments (open)
Tab 8: Quality System Documentation
- GLNPO ID #
»• Date entered
»• Quality system documentation (check QMP or QAPP)
»• Quality system documentation (open)
»• Quality system documentation type (modeling, habitat restoration, secondary data, monitoring,
research analytical, sediment assessment, sediment remediation)
*• Date QS documentation due
- GLNPO Lead
*• Funding branch
*• Funding team
*• Date to QA manager
*• Quality system review checksheet (open)
*• Initial approval date
*• QA approval ID
*• Approval status (no submittal, under review, approved, approved w/minor revisions, unacceptable,
delinquent)
*• Date of review completion
*• Date of final approval
*• Audit checksheet (open field)
»• Date of audit
*• Audit summary report (open field)
»• Data files (open field)
»• Data assessment report (open field)
»• Comments (open field)
»• Contacted recipient (check mark)
*• Second contact with recipient (check mark)
•• Delinquent but not significantly affecting quality (check mark)
»• 1st Phase Delinquency (check mark)
»• Letter sent to PO (check mark)
*• Teleconference (checkmark)
*• Cc letter sent to branch chief (check mark)
*• 2nd Phase Delinquency (check mark)
*• Letter sent to branch chief (check mark)
*• Seriously Delinquent (checkmark)
*• Letter sent to grantee from director (check mark)Suspension letter sent to grantee (check mark)
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*• Teleconference (check mark)
»• Debarment and suspension call and letter sent to grantee (check mark)
»• Withdraw funds (check mark)
»• Comments (open)
Tab 9: Peer Review
- GLNPO ID #
»• Date entered into peer review database
*• Objective (open)
*• Cross-cutting science issues (older Americans, children's health, tribal science, contaminated
sediments, cumulative risk, indoor environments, environmental justice, genomics)
»• Peer Review Leader (name and phone)
*• Science Category (major scientific/technical, non-major scientific/technical, major economic, non-
major economic, major social science, non-major social science, other)
*• Environmental Regulatory Model (new, modified, new application, N/A)
*• Environmental Medium (air, human health, multimedia, terrestrial, water, other)
*• Peer Review Type (internal, external, to be determined)
*• Peer Review Mechanism (text)
*• Results of Peer Review Comments (substantive revision to final product, minor revision to final
product, no significant change to final product, product was terminated, to be determined)
*• Peer Review Charge/Instructions (open)
*• Peer Reviewer Name & Affiliation (text)
*• Peer Review Comments (open)
*• Management Decision on Comments (open)
*• Location of Peer Review File (text)
*• File Contact Name, organization, telephone (text)
*• Additional Supporting Documentation / Comments (open)
»• Date of projected peer review
»• Date peer review was conducted
»• Date peer review was completed
»• Date final peer review comments were received
»• Date of management decision on peer review comments
»• Comments (open)
2.7 QUALITY MANAGEMENT TEAM MONTHLY REPORTS TO MANAGEMENT
GLNPO's Quality Management Team presents a status report on quality management activities
associated with all GLNPO-funded EICAA's each month during a management meeting. GLNPO uses a
monthly quality assurance status tracking sheet (Appendix C) to summarize and present the status of
these activities to management. The Team provides for all outstanding EICAA's, a list of required
quality system documentation, the due dates for the documentation, and the review and approval status of
the documentation. These reports are designed to also serve as a management tool to evaluate office
work loads.
2.8 REVIEWS OF QUALITY SYSTEM IMPLEMENTATION AT THE BRANCH LEVEL
GLNPO recently established a new procedure to facilitate assessing quality system
implementation at the Branch level. GLNPO's Office Director will meet with each Branch Chief twice
yearly regarding adherence to the quality system by all EICAA's administered through the branch. Prior
to the meeting, GLNPO's Quality Manager will prepare a briefing document on implementation of the
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quality system, including the status of quality system documentation, the status and results of all
technical system audits or reviews, and outstanding issues. This meeting will function to close the loop
on the quality system cycle from planning and implementation to assessment and applying corrective
action when needed.
2.9 ANNUAL REPORT AND WORKPLAN
GLNPO is required to submit a quality assurance annual report and workplan (QAARWP) to
OEI's Quality Staff. GLNPO's Quality Manager will follow the outline provided by Quality Staff.
Every year, GLNPO's Quality Management Team prepares a performance agreement along with the
other GLNPO functional teams. This performance agreement serves as the workplan within the annual
report. In the annual report, an inventory of all EICAA's is provided that includes: information regarding
the number of quality system documentation packages that were submitted to GLNPO and reviewed
throughout the year, the status of quality system documentation for all ongoing and scheduled EICAAs,
and an overview of workload distribution within the office. The report is organized so that it can be used
as management tool for assessment of EICAA's and staffing issues.
2.10 QUALITY SYSTEM AUDITS AND TECHNICAL SYSTEM AUDITS
Quality systems audits (QSAs), previously termed management systems reviews, are on-site
evaluations by internal or external parties to determine if the organization is implementing a satisfactory
quality management program. They are used to determine the adherence to the program, the
effectiveness of the program, and the adequacy of allocated resources and personnel to achieve and
ensure quality in all activities. Internal QSAs are conducted by GLNPO senior management.
GLNPO-funded entities also may undergo QSAs lead by GLNPO's Quality Manager. External QSAs are
conducted by EPA Quality Staff to determine compliance of GLNPO's program with this QMP.
Technical systems audits (TSAs) are qualitative on-site evaluations of all phases of an EICAA(i.e.,
sampling, preparation, analysis). These audits can be performed prior to or during the data collection
activity, in order to evaluate the adequacy of equipment, facilities, supplies, personnel, and procedures
that have been documented in the quality system documentation. Because a TSA is most beneficial at the
beginning of a project, GLNPO schedules audits at the initiation phase of an EICAA, when possible.
GLNPO performs a QSA, site visit, or TSA for the most high-profile EICAA's (i.e., those that support an
important decision). The number and frequency are dependent on the length of the project, the
importance of the project objectives, and the evaluations of prior audits. Technical System Audits and
QSAs are discussed in Section 9.1
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Section 3
Personnel Training and Qualifications
The success of any quality management program ultimately lies with the personnel who
implement the program on a daily basis. GLNPO must not only support activities that will satisfy the
mandatory quality management program, but also instill the philosophy of improving activities to provide
the highest quality data in a cost-efficient manner. It is GLNPO policy to provide the quality system
training necessary to ensure that all staff involved with the generation and use of environmental data
understand and use GLNPO's quality system. Management is committed to ensuring that GLNPO
personnel responsible for EICAAs have the necessary education, training, and experience to develop,
control and evaluate data quality. The following sections describe GLNPO's quality system training
program.
3.1 QUALITY MANAGER TRAINING
The Quality Manager regularly attends national and, in some cases, international conferences and
meetings on quality systems and the development of quality management materials and protocols relevant
to GLNPO. The Quality Manager will participate in training courses on quality management topics, such
as data quality assessment and QAPP development. This will assure that GLNPO personnel receive up-
to-date training on a variety of quality assurance subjects including EPA's quality policy.
3.2 GLNPO PERSONNEL QUALITY SYSTEM TRAINING
Supervisors are responsible for ensuring that staff have the qualifications to do their jobs,
including those related to the quality system. Managers are responsible for discussing quality training
needs with personnel involved in EICAAs during the mid-year and annual personnel performance
evaluations.
In addition, because line management is ultimately responsible for the quality of data, managers
and supervisors also must receive the
necessary training to ensure their
Repetition is critical to raising awareness
understanding of the importance of the
quality system, their responsibilities as
managers of data collection activities, and
specific GLNPO quality system policies and procedures.
Training schedules will be developed in order to optimize attendance. Training may consist of
seminars or classes, or on-the-job training. If training cannot be met through in-house expertise, it may
be accomplished through external organizations. Training also will be available to all personnel
cooperating on GLNPO projects (universities, other agencies etc.). It will be the responsibility of the
GLNPO projects leads to make cooperators aware of these training opportunities. The Quality Manager
will provide the following training at least every three years:
*• Overview of GLNPO's Quality System »• GLNPO Quality System Training for Project
»• QA Project Plan development Officers
*• Auditing and data verification/validation techniques
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The Quality Manager will develop a library of pertinent quality management documentation to
assist GLNPO technical staff. The library will include documentation as well as software training
programs. The minimum required quality management training for GLNPO staff is detailed in Table 3-1.
Table 3-1. Quality Management Training Requirements for GLNPO Staff
Position
Managers (Branch Chiefs, Division Directors)
Work Assignment Managers, Project
Managers, Project Officers
GLNPO Quality Management Team
All GLNPO staff involved in the generation or
use of environmental information
Quality Management Training Requirements
•• Overview of GLNPO's Quality System (every 3 years)
•• Orientation to Quality Assurance for Managers (1 time only)
•• Overview of GLNPO's Quality System (every 3 years)
•• GLNPO Quality System Training for Project Officers (every 3 years)
•• Overview of GLNPO's quality system (every 3 years)
•• Development of Quality Assurance Project Plans (1 time only)
•• Data Quality Assessment (1 time only)
•• Development of Quality Management Plans (suggested course)
•• Overview of GLNPO's quality system (every 3 years)
Attendance at the courses will be recorded, and attendees will receive a written record from the
Quality Manager or instructor after completion of a course. The Quality Management Team will
maintain records of the quality system training taken by personnel in each Program Office. A summary
of the quality system training will be provided in the annual report, including, but not limited to, a list of
the courses offered, the number of attendees, and a listing of all participating organizations. Whenever a
new QMP is developed or whenever significant revisions to the QMP are conducted, training will take
place within 6 months of approval of the QMP by OEF s Quality Staff in order to ensure GLNPO staff are
fully informed of the quality system at any given time.
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Section 4
Procurement of Items and Services
GLNPO must ensure that procured items and services meet EPA regulations, are delivered in a
timely fashion, and are within GLNPO's specifications. The following sections describe GLNPO's
procurement procedures.
It is GLNPO policy that quality system requirements be explicitly addressed when acquiring
items or services that involve EICAA's. This policy applies to procurements such as contracts, as well as
to cooperative agreements, partnership agreements, grants to institutions of higher education, and other
non-profit organizations, Tribes, States, local governments, and interagency agreements. The following
Federal regulations contain sections relating to quality management or quality systems:
- 48 CFR Part 46. Quality Assurance
*• 40 CFR Part 30. Grants and Agreements with Institutions of Higher Education, Hospitals, and Other
Non-Profit Organizations
»• 40 CFR Part 31. Uniform Administrative Requirements for Grants and Cooperative Agreements to
State and Local Governments
- 40 CFR Part 35. State and Local Assistance
In addition, there are other rules and regulations that apply to contracts and other forms of
financial assistance, including grants, assistance agreements, performance partnership agreements, and
interagency agreements, as described below.
4.1 PROCUREMENT OF ITEMS
GLNPO utilizes the services of the EPA Region 5 Purchasing Section of the Contracts and
Grants Branch for its procurement needs. The Purchasing Section follows the guidelines in Section 13 of
the Federal Acquisition Regulations (FAR) which establishes government-wide policies and procedures
governing the acquisition process. Two EPA documents: EPA 1900-Contract Management Manual and
the EPA Acquisition Regulation Manual (EPAAR) have been developed to supplement the FAR. Region
5 is required to implement the regulations in these documents. EPA attempts to purchase through FAR
mandatory sources (i.e., GSA): items on the FAR source list that meet the minimum specifications on the
procurement request must be purchased through a FAR source. Procurements of computer hardware and
software have a distinct process. Computer procurements will be developed by the Information
Management and Data Integration Team and adhere to Region 5 policy.
Requests for purchases and identification of funds begins at the planning stages of any GLNPO
project. In order to assure agreement among GLNPO POs, principal investigators, and the Region 5
Purchasing Section, requesters should explicitly identify all items and associated specifications required
to meet the government's minimum needs. These specifications will be required during the procurement
process. In order to provide the Region 5 Purchasing Section with the correct information, it is suggested
that the specifications be developed or reviewed with a purchasing agent before initiating the
procurement request. This will assure that the GLNPO requestor will receive the proper item and reduce
the chances of purchase delays or incorrect purchases due to inadequate product specifications. The
purchasing agent also can assist the requestor in preparing the procurement request form.
GLNPO utilizes procurement request forms (EPA form 1990-8) to initiate requests. These forms
will be reviewed by the GLNPO planning and management staff for completeness and accuracy then
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forwarded to appropriate GLNPO staff for required GLNPO reviews and approvals. The procurement
request will then be forwarded for additional reviews and approvals to the Region 5 Budget Office. The
Budget Office certifies that funds are available and the Budget Services Center assigns a document
control number (DCN). The Budget Office forwards the procurement request to the Property
Management Officer for signature. Finally, the request is sent to the Region 5 Purchasing Section. The
approval process may take up to two weeks from the time the procurement request is written until it
arrives at Region 5 Purchasing for approval and procurement. If the item is required sooner, the
procurement request must be "walked through" the approval process.
4.2 PROCUREMENT OF SERVICES
Two types of mechanisms are principally used to procure services; contracts and assistance
agreements (grants, interagency agreements etc.). At GLNPO, contract officers are the only individuals
authorized to obligate funds for services.
Certain activities are of a policy and decision-making nature and should remain the sole authority
of the EPA. Therefore, contracts or assistance grants should not include the following services:
*• the actual preparation of Congressional testimony;
*• the interviewing or hiring of individuals for employment by EPA;
*• developing and/or writing of Position Descriptions and Performance Standards;
*• the actual determination of Agency policy;
*• participating as a voting member on a Performance Evaluation Board; participating in and attending
Award Fee meetings;
*• preparing Award Fee letters, even under typing services contracts;
*• the preparation of documents on EPA letterhead other than routine administrative correspondence;
*• reviewing vouchers and invoices for the purposes of determining whether cost hours, and work
performed are reasonable;
*• the development of Statements of Work, Work Assignments, Technical Direction Documents,
Delivery Orders, or any other work issuance document under a contract the contractor is performing
or may perform;
»• on behalf of EPA, actually preparing responses to audit reports from the Inspector General, General
Accounting Office, or other auditing entities;
»• on behalf of the EPA, actually preparing responses to Congressional correspondence;
»• the actual preparation of responses to Freedom of Information Act requests, other than routine,
non-judgmental correspondence-in all cases, EPA must sign it;
»• any contract which authorizes a contractor to represent itself as EPA to outside parties; and
*• conducting administrative hearings.
In the past, contract and assistance agreements were utilized to provide QA/QC support to EICAAs.
Such use of non-EPA personnel could result in situations in which inherent government functions are
being performed by non-governmental personnel or in which potential conflict of interest could occur.
Table 4-2 lists quality management tasks as either EPA only tasks or discretionary tasks which may be
performed by EPA or non-EPA support staff.
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Table 4-2. Quality Management Task Performance by EPA and Non-EPA Personnel
Quality Management Task
Details
Performed by:
Manage and coordinate
quality system (quality
management program)
Manages the day-to-day operation of GLNPO's mandatory
quality system (quality management program)
Acts as a liaison between the organization and OEI's Quality
Staff on matters of quality policy
Coordinates with senior management on the development
and preparation of the organization's QMP that describes the
quality system implemented by the organization
Coordinates with senior management on changes to the
quality system as needed to assure its continued
effectiveness and reports the results annually to
management and to OEI's Quality Staff in the QA Annual
Report and Workplan (QAARWP)
Manages organization resources designated for the quality
system (quality management program)
Maintains pertinent records of all quality system activities
performed by the organization
EPA only
Review and approve
procurement and financial
assistance documents for QA
requirements
Reviews procurement and financial assistance documents to
confirm that any need for QA requirements has been
established, provides any necessary special language or
conditions for such QA requirements, and approves by
signing the appropriate Quality Assurance Review (QAR)
Form
Participates directly or indirectly in the proposal or
cooperative agreement/grant review processes to advise the
PO on the suitability of the offerer's Quality System (QA
program) or QA/QC approach for the particular project.
Reviews work assignments to certify that appropriate QA
requirements have been established and that the necessary
instructions are being communicated to the contractor to
carry out the expected QA/QC tasks and provides signature
approval
EPA only
Review and approval of
quality management planning
documents
Reviews QA Project Plans (QAPPs) for all projects, work
assignments, grants, cooperative agreements, and
inter-agency agreements involving data acquisition, data
generation, and/or measurement activities that are performed
on behalf of EPA
EPA only
Approves all QAPPs for implementation in all applicable
projects, work assignments, grants, cooperative agreements,
and inter-agency agreements performed on behalf of EPA
and where specific approval of QAPPs has been delegated to
a responsible EPA official, the Quality Manager reviews the
QAPPs for concurrence
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Quality Management Task
Details
Performed by:
Coordinates the correction of deficient QAPPs with the PO
and his/her management, and assures through appropriate
procedures (e.g., contract, financial assistance) that no data
collection operations commence before a QAPP is approved
Reviews, at the specific technical direction of the Quality
Manager, QAPPs and other QA-related planning documents,
such as sampling and analysis plans, DQO specifications,
etc., to determine if the proposed QA approach documented
is adequate for the work planned, based on explicit
evaluation criteria provided by the Quality Manager (the
reviews should identify specific technical deficiencies in the
QAPP to the attention of the Quality Manager)
Discretionary
tasks
Review and technical
assistance in developing and
preparing experimental
designs
Interprets Agency policy and requirements pertaining to
developing and preparing experimental design requirements
Provides corrective action technical assistance and guidance
to intramural and extramural researchers to enable them to
produce, in a timely manner, satisfactory experimental design
documents using the DQO process
EPA only
Using explicit criteria provided by the Quality Manager,
reviews experimental designs produced to determine if
satisfactory results can be obtained from the design and
provides the Quality Manager with a technical assessment of
strengths and weaknesses in the design
Discretionary
tasks
Tracking and reporting of QA
program deliverables
Tracks critical QA program deliverables for the organization
and makes periodic reports to senior management on the
status of reporting actions and deliverables
EPA only
Compiles/logs administrative management information
including:
- turnaround times to correct QAPPs,
- responses to audits, and
- quality reviews of final reports
Discretionary
tasks
Management of contractor
support work assignments
Serves as PO of record for contracts established to provide
QA support to the organization and usually serves as the
Work assignment manager (WAM) for specific work
assignments involving QA activities within the same or other
contracts
EPA only
Conduct management
assessments
Plans, directs/conducts, and reports to senior management
the results of annual assessments of effectiveness of the
quality system (QA program) being applied to EICAAs.
Coordinates with senior management any revision of the
quality system (QA program) as necessary based on findings
of the assessment.
EPA only
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Performed by:
Provides technical support to EPA Quality Manager in the
planning phase of management assessments (such activities
are limited to the assembly and compilation of background
information and data, guidance documents, technical reports,
etc., available in public domain, for use by EPA in designing
the assessment goals and specifications)
Discretionary
tasks
Conduct technical
assessments
Plans and directs, with the responsible EPA PO, the
implementation of periodic technical assessments of ongoing
EICAAs that technical and quality objectives are being met
and that needs of the customer are being satisfied (such
assessments include technical systems audits, audits of data
quality, surveillance, performance evaluations, and data
quality assessments)
EPA only
Performs technical assessment (as listed above) of the
organization's EICAAs, both intramural or extramural
according to a specific plan prepared by the Quality Manager
in the presence of the Quality Manager or authorized EPA
official (preparations for such assessments may include the
acquisition or development of audit materials and standards.
Results (findings) are summarized and presented to the
Quality Manager, or authorized EPA official, for determination
of conclusions and necessary actions, if any)
Discretionary
tasks
Preparation and presentation
of quality management
subjects in the technical
literature and at
meetings/symposia
Represents EPA in transferring quality management subjects
to other Agency, public, or scientific groups through:
- participation in technical meetings and symposia, and
- participation in technical literature, including peer-
reviewed journal papers, oral presentations, and panel
discussions
EPA only
Transfers quality management subjects to other groups
through participation in technical meetings and symposia and
through the technical literature, with appropriate disclaimer
that the information does not represent EPA policy or position
(only EPA personnel may represent the Agency in an official
role)
Discretionary
tasks
Research relative to quality
management issues
The Quality Manager should be kept abreast of advances in
quality management through technical literature, training, and
symposia to create opportunities for improvements to the
organization's quality system (QA program)
Performs searches of the technical and quality management
literature relative to specific QA/QC issues including
compiling summaries of alternative sampling and analytical
methods, identification of QC reference material, and
availability of standard operating procedures for calibrating
certain instrumentation
Discretionary
tasks
Preparation and
presentations of QA training
materials and courses
Develops and presents detailed guidance and training for
QA/QC activities based on interpretation of Agency-wide
requirements and guidance.
EPA only
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Quality Management Task
Details
Performed by:
Provides or coordinates quality-related training for the
organization in special skill areas not generally available to
the organization
Provides assistance in preparing and presenting
quality-related technical training (within constraints of
potential conflict of interest)
Discretionary
Tasks
Quality review and approval
of final reports
Defines criteria for the acceptability of quality documentation
in the organization's published papers and reports
Approves for publication only those papers and reports that
contain an adequate discussion of the quality of the projects
results and the usability of the data produced
EPA only
Conducts a review of all reports produced by the organization
using the qualitative and quantitative specifications obtained
from the DQO process to ensure that an adequate discussion
of the quality of the project results and the usability of the
data produced are included (This quality review complements
the peer review process and documents that the results of
the EICAA have or have not been reconciled with the quality
objectives. Results of any reviews performed by non-EPA
support personnel are presented to the Quality Manager for
decision on the acceptability of the report)
Discretionary
tasks
As it does for procurement of items, GLNPO utilizes the services of the EPA Region 5 Contracts
Management Branch for the procurement of services. This group must approve all contracts and
agreements before they are implemented. It is GLNPO policy that before any funding of contracts or
agreements containing EICAAs is initiated, appropriate quality system documentation must be submitted.
To that end, all procurement packages and associated quality system documentation are reviewed by the
Quality Manager. The documentation must be reviewed by the GLNPO Quality Manager and determined
to be "acceptable with minor revisions" (see Appendix J) prior to initiation of an EICAA. Information on
the development of quality system documentation is detailed in Section 2. In order to determine whether
quality system documentation is required, GLNPO POs can use the Quality System Documentation
Checklist (Appendix F). The PO is responsible for ensuring that the technical requirements of the quality
system are satisfied. It is GLNPO policy that all POs overseeing contracts and assistance agreements be
certified through PO and contract administration training.
4.2.1 CONTRACTS
GLNPO conducts procurement functions in accordance with the Federal Acquisition Regulations
(FAR), and generally accepted business practices for the acquisition process. The FAR was recently
amended to address contract quality systems requirements on a government-wide basis. The new FAR
contract clause at 52.246-11, Higher-Level Contract Quality Requirements (February 1999), as
prescribed by FAR 46.311, allows a Federal agency to select a voluntary consensus standard as the basis
for its quality requirements for contracts, and identifies ANSI/ASQC E4-1994, Specifications and
Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology
Programs, as an acceptable standard.
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Due to these FAR changes, EPAAR 1546.2, Contract Quality Requirements (March 1984),
which is a quality regulation that applies only to EPA, was determined to be unnecessary and the
pertinent requirements from EPAAR 1546.2 will be included in the EPA Directive 1900, Contracts
Management Manual (CMM).
The EPA Office of Acquisitions Management issued Procurement Policy Notice No. 01-02 in
March 2001 that provides guidance for the use of these higher-level contract quality requirements.
Notice 01-02 includes two attachments that provide directions for contracting officers and their
representatives in the program offices (e.g., PO and Work Assignment Managers), as well as quality
staff, and describes the process for determining the quality system requirements that must be included in
contract acquisition packages.
Contracts are used when the government derives sole benefit from a particular product or service.
Contracts can be specific and require a degree of lead time for development. Depending upon the scope
of the service, quality assurance requirements that must be adhered to under the terms and agreements of
the contract are developed. Currently, POs and their supervisors are responsible for review of
procurement packages. GLNPO relies on the contract officer, PO, work assignment manager, and
specialist (as appropriate) to include required documentation. GLNPO quality staff also will assist in the
contracting process by evaluating quality system documentation submitted by contractors in response to
either pre-award or post-award requirements. As noted in the EPA 1900 — Contracts Management
Manual, a member of the GLNPO's Quality Management Team at the appropriate level will be involved
for procurements over $500,000, in cases where quality system requirements are applicable to the
procurement. GLNPO's Quality Manager will generally fulfill this role.
GLNPO's management staff and Quality Management Team play active roles in assisting the
contract management staff in defining the quality system requirements for contracts. Contracts involving
EICAAs will include requirements for the provision of a quality management plan and quality assurance
project plans, or other appropriate quality system documentation.
In procuring services, responsibility does not follow the line of authority. The PO, as a
functional person, submits a request stating the desired service, measures the quality of the service, and
accepts the service. The Contracting Officer provides the means of getting a contract and enforcing the
provision. The PO has overall responsibility to see that the service is provided but works through the
contracting officer's authority. The PO is appointed by the Contracting Officer and formally designated
as a technical representative of the Contracting Officer in the contract. Project Officers must complete
PO and contract administration training to serve on a contract. Chapter 7 of the EPA Contracts Manual
(EPA-1900) specifies the required training, experience, and workload limitations for an individual to
serve as a PO. GLNPO will adhere to these specifications. Two major tools to ensure that adequate
service is provided are a well-defined statement of work (SOW) and quality system documentation that
includes reviews (audits).
Whenever the government enters into a contract, it is entitled to receive quality service. In order
to define and measure quality, the PO must develop a statement or scope of work (SOW) that will
accurately define the minimum acceptable requirements for the service. This is the first step in the
procurement process that helps to ensure that services produce results or products of acceptable quality.
The PO must succinctly state their expectations of the product or service and be able to relate this to the
supplier. Good communication between the PO and the supplier of a product or service is essential to a
mutual understanding of what the expectations are and how quality will be defined. Methods used to
determine quality (audits, quarterly interviews, random inspections etc.) should be explained prior to
project implementation so that the supplier will understand how quality will be assessed. Supplement #2
to OMB circular A-76, A Guide For Writing and Administering Performance Statements of Work for
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Service Contracts, provides good guidance for writing SOWs and implementing QA surveillance plans.
Another important source of information is the EPA 1900-Contracts Management Manual which
specifies all required documents for developing contracts. The Quality Manager will maintain copies of
both documents in the QA library.
GLNPO personnel must be aware of "personal services," which are characterized by an
employer-employee relationship between government and contractor employees. These contracts are
illegal in EPA. Personnel services conflicts arise when government employees assume the right to
instruct, supervise, or control a contractor's employee in how they perform work. It is the contractor's
right to hire and terminate, to assign, and to organize and implement tasks, as the contracting
organization deems appropriate. GLNPO may tell the contractor what to do within the terms and
agreements of the contract, but not how to do it.
4.2.2 ASSISTANCE AGREEMENTS
Assistance agreements are used when both parties (EPA and the group providing the service)
derive benefit out of the service. This usually occurs with grants, cooperative agreements, or interagency
agreements (lAGs) where universities or States derive benefits from participating in EICAAs. If the
project involves environmentally-related measurements or generation of either primary or secondary
data, then the applicant/recipient must develop and implement a quality management system. Grants are
assistance agreements where EPA has no substantial involvement in the project. Cooperative agreements
are assistance agreements where EPA has substantial involvement in the project.
As discussed in the EPA proposed Order, Policy for Competition in Assistance Agreements, July
15 2002, it is EPA policy to promote competition in the award of assistance agreements to the maximum
extent practicable. When assistance agreements are awarded competitively, it is EPA policy that the
competitive process be fair and open and that no applicant receive an unfair competitive advantage. It is
GLNPO policy to promote fair and open competition in the award of assistance agreements and GLNPO
is committed to meeting the specifications of EPA's final order on this subject. This policy will be
discussed as part of the staff training session, Overview ofGLNPO's Quality System.
GLNPO follows guidelines developed in the EPA Assistance Administration Manual
(EPA-5700) and in the 4th edition of Managing Your Financial Assistance Agreement - Project Officer
Responsibilities (EPA 202-B-96-002, January 2000). Project Officers are responsible for incorporating
project materials into the official working files located in the GLNPO central standardized filing system
(see section 5).
A Project Inventory and Approval Form (Appendices H and I) is used to determine if a grant or
IAG package contains all required components in appropriate format with sufficient documentation. This
is usually completed by the PO and the Grants Specialist. The GLNPO Quality Manager also will review
the application to determine the QA and peer review requirements and sign this checklist. All decisions
on the checklist are sanctioned by the GLNPO Director through signature. The PO is responsible for
submitting the checklist to the Quality Manager. The Quality Manager also will use the information for
tracking progress on the development of project quality system documentation.
For assistance agreements, SOWs are usually developed jointly. However, once the SOW is
completed, the parties also must agree on the quality standards for assuring the product or service. It is
the responsibility of the PO to be aware of EPA QA policy and to work with the GLNPO Quality
Manager to represent these standards during the development of the projects SOW.
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All assistance agreements originating within GLNPO must meet established administrative and
quality assurance requirements in the latest editions of the following:
*• Assistance Administration Manual, EPA Directive 5700, 1984 Edition (or later);
»• EPA Order 5700.1, Policy for Distinguishing Between Assistance and Acquisition, March 22, 1994;
»• EPA Order 5730.1, Policy and Procedures for Funding Assistance Agreements, January 21, 1994;
»• 40 CFR Part 30, Grants and Agreements with Institutions of Higher Education, Hospitals, and Other
Non-Pro fit Organizations;
»• 40 CFR Part 31, Uniform Administrative Requirements for Grants and Cooperative Agreements to
State and Local Governments; and
- 40 CFR Part 35, State and Local Assistance.
As stated in Managing Your Financial Assistance Agreement (EPA 202-B-94-001, May 1994), it
is Agency policy that applicants are required to develop and implement quality management practices for
all projects involving environmentally-related measurements or data generation. These practices consist
of policies, procedures, specifications, standards, and documentation which will produce data of
sufficient quality to meet project objectives and will minimize loss of data due to out-of-control
conditions or malfunctions. All applicants for grants or cooperative agreements involving environmental
programs shall submit quality system documentation which describes the quality system implemented by
the applicant, which may be in the form of a quality management plan or equivalent documentation. In
keeping with the graded approach described throughout this plan, GLNPO policy requires that all parties
receiving EPA grants/financial assistance under which EICAA's are performed include either a quality
assurance project plan that has been prepared in accordance with EPA Requirements for Quality
Assurance Project Plans (Final, March 2001), or equivalent quality system documentation.
The applicant's quality system documentation shall indicate whether the assistance involves an
environmental information collection or use. The applicant is requested to submit a description of the its
program or project as part of the workplan submitted with Standard Form 424.
The level of documentation must be established by GLNPO staff when planning for the grant or
financial assistance. If the applicant has an EPA-approved QMP or QAPP and it covers the project in the
application, then they need only reference the plan in their application. The quality assurance project
plan must be acceptable to the Award Official in order to receive a grant award.
The grant applicant is responsible for preparing the quality system documentation, which is then
reviewed and certified by the Quality Manager or his designee prior to initiation of the EICAA. For
financial assistance grants under the purview of Regions, the Regional Quality Assurance Officer or his
designee is responsible for the review and approval of the quality system documentation. At the request
of the Regional Quality Assurance Officer, the quality system documentation also maybe reviewed and
cosigned by GLNPO's Quality Manager.
If an applicant is unfamiliar with EPA and the GLNPO quality requirements, the PO should
direct them to the appropriate quality staff, either in the GLNPO, or in the Office of Environmental
Information. The following are quality requirements by applicant type:
*• If an application is for research financial assistance, the application must include a quality statement
which either addresses certain areas or provides justification why specific areas do not apply [see 40
CFR30.503(d)].
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»• If an application is from a State or Tribal government (except for a wastewater treatment
construction grant) the applicant must define their plans for completion of the necessary quality
system documentation
»• All other applicants must submit quality system documentation with their application.
The decision on whether a grant or cooperative agreement involves environmental information
collection or use is determined by the GLNPO PO in consultation with the Quality Management Team
and a review of the project workplan. Project Officers approve projects, subject to their terms and
conditions, during the "award phase" of the project. At that time, they review award documentation
prepared by the Assistance Section, develop and initial a transmittal letter, and pass the package "up-the-
chain" for sign off by Team Leaders, Management, and the Great Lakes National Program Manager.
The applicant's quality system documentation will be reviewed and approved as a condition for
award of any assistance agreement. The quality system documentation must be submitted as part of the
application (unless GLNPO-approved quality system documentation is cited in the application).
If the quality system documentation is not submitted as part of the application, GLNPO will, in some
cases, fund the project and include a term and condition in the assistance agreement. This term and
condition requires the recipient to submit the quality system documentation within a specified time after
award of the agreement and notifies the recipient that they may not begin the EICAA until the GLNPO
PO informs them that the quality system documentation has been approved (Section 4.2.3).
When States receiving funds from GLNPO agree to enter into performance partnership
agreements with GLNPO, the performance partnership agreements will be used as a mechanism to define
the quality system requirements for the effort and to establish the respective roles of and responsibilities
of the State and GLNPO in quality management activities.
Interagency agreements that are funded by GLNPO should include quality system documentation
requirements in the agreement. Because GLNPO cannot unilaterally impose such requirements, these
requirements must be negotiated into each agreement. Policies and administrative procedures governing
interagency agreements are defined in Chapter 5 of Managing Your Financial Assistance Agreement.
The GLNPO quality system requirements related to environmental data apply to all activities funded by
GLNPO through interagency agreements. Cooperative agreements that will involve EICAA's must
adhere to the quality system documentation requirements in 40 CFR 30.503. These standards must be
included explicitly in all cooperative funding agreements.
All interagency agreements with EICAA's which GLNPO funds, or participates in, will include
quality system documentation. Where GLNPO is providing funds to another organization, that
organization is responsible for preparing the quality system documentation. If the other organization has
equivalent requirements for quality system documentation, that guidance may be employed. If there are
not comparable quality system procedures, the quality system procedures agreeable to both parties must
be negotiated prior to initiation of the program or effort and are attached to the Memorandum of
Decision. The quality system documentation will be reviewed and certified by GLNPO's Quality
Manager prior to initiation of the EICAA. All proposed cooperative funding agreements shall be
reviewed to determine the applicability of quality system requirements as defined in EPA Order 5360.1
A2. This determination shall be documented by the GLNPO Quality Management Team.
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Where a quality management plan is required, the plan shall be prepared in accordance with the
specifications provided in the most current version of EPA Requirements for Quality Management Plans
(QA/R-2), which describes the quality system implemented by the party involved in the environmental
program. The plan shall define the approving officials of the plan, which, at a minimum will include the
GLNPO Quality Manager.
4.2.3 SPECIAL CONDITIONS
Special conditions are usually included in assistance agreements. The PO will list the conditions
for which project participants must adhere. One of these conditions relates to quality system
documentation. Any assistance agreement that includes environmental information collection activities
must include the following statement:
Projects involving collection of environmental data (measurements or information that describe
environmental processes, location, or conditions; ecological or health effects and consequences;
or the performance of environmental technology) must meet the American National Standard
Specifications and Guidelines for Quality Systems for Environmental Data Collection and
Environmental Technology Programs, ANSI/ASQC E4-1994. "Quality System Documentation"
includes a Quality Management Plan (QMP), a Quality Assurance Project Plan (QAPP), or such
other documentation which demonstrates compliance with ANSI/ASQC E4-1994.
An applicant with current, approved Quality System Documentation will, by the earlier of (i) the
30th day prior to collection of environmental data and (ii) the 90th day after the project start date,
notify GLNPO's Quality Assurance Manager of the way it is applying the above standard to this
project. In all other cases, Quality System Documentation shall be submitted for approval to
GLNPO by the earlier of (i) the 30th day prior to collection of environmental data and (ii) the
90th day after the project start date. Costs associated with data collection are not allowable costs
until Quality System Documentation is approved by the GLNPO Quality Manager.
Contact GLNPO's Quality Manager, Louis Blume (312) 353-2317 with questions or to request
sample documentation. Further guidance is available in the Grants Requirements/Instruction in
the Application Kit and from < http://www.epa.gov/quality/qa_docs.html >, which includes the
document "QA/R-5: EPA Requirements for Quality Assurance Project Plans."
In some cases, exceptions to this condition are made. For example, the time constraint maybe
lengthened in cases where GLNPO is working with State agencies and the funds are going to a
subcontract.
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Section 5
Document Control and Records
Organizations that perform EICAAs must establish and maintain procedures for the timely
preparation, review, approval, issuance, use, control, revision and maintenance of documents and
records. A document is any volume that contains information which describes, defines, specifies,
reports, certifies, or provides data or results pertaining to environmental programs. As defined in the
Records Disposal Act of 1943 (now 44 U.S.C. 3301), records are: "...books, papers, maps, photographs,
machine readable materials, or other documentary materials, regardless of physical form or
characteristics, made or received by an agency of the United States Government under Federal Law or in
connection with the transaction of public business and preserved or appropriate for preservation by that
agency or its legitimate successor as evidence of the organization, functions, policies, decisions,
procedures, operations, or other activities of the Government or because of the informational value of
data in them...." This section will define GLNPO's document control and records procedures.
5.1 MANAGEMENT OF DOCUMENTS AND RECORDS
GLNPO has centralized the office function to manage documents and records by establishing a
staff role, the document control coordinator (DCC). The staff member that fulfills this role is within the
Communications and Reporting Team in Policy Coordination and Communications Branch. This
document control coordinator is responsible for the following activities:
*• Coordinating assignment of EPA document numbers,
*• Conducting review of documents as requested, and
*• Maintaining inventory of all GLNPO documents with EPA numbers.
POs are responsible for submitting deliverables associated with an EICAA (planning documents,
progress reports, final reports etc.) to the DCC for entry into the system. The DCC also will maintain
submitted copies of these deliverables in central marked files for proper storage and protection from
degradation. Soft-copies are maintained on GLNPO's local area network (LAN). Backups of the LAN
are made periodically and maintained offsite. Document preparation, review, and approval will be
dependent upon the type of document being produced. For example, an internal document will have
different preparation, review, and approval requirements than an external document. The process
befitting each document will be determined by the task leader and immediate supervisor. The process for
quality system documentation is discussed in Section 2.
5.2 VERSION CONTROL
In order to ensure that GLNPO staff and involved parties are using current documents, GLNPO
uses version control procedures that are consistent with ISO 9000 for documents that support critical
activities. Currently, these include: 1) this Quality Management Plan, 2) the SOP document in support of
GLNPO's base monitoring program, Sampling and Analytical Procedures for GLNPO's Open Lake
Survey of the Great Lakes, and 3) the GLNPO Health, Safety, and Environmental Compliance Manual.
GLNPO's procedure involves placing these controlled copies in blue binders for easy identification.
Controlled copies of a particular document will be provided to individuals with signature approval for
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that document. All GLNPO staff are informed of this procedure during GLNPO's training on the quality
management system. POs are responsible for ensuring that all relevant parties involved in EICAA's are
aware of GLNPO's controlled copy policy to ensure they locate the current document when needed.
When a new version of a controlled documents is created, a summary of revisions will be maintained
with the controlled copies.
5.3 INFORMATION QUALITY GUIDELINES
Recently, EPA developed Information Quality Guidelines to comply with an Office of
Management and Budget (OMB) guideline (FRL-7157-8, March 2002). Section 515 of the Treasury and
General Government of Appropriations Act for FY2001 (Public Law 106-554) directed OMB to issue
guidelines that "provide policy and procedural guidance to Federal agencies for ensuring and maximizing
the quality, objectivity, utility, and integrity of information, including statistical information,
disseminated by Federal agencies." EPA posted the final EPA Information Quality Guidelines (IQGs) on
October 2, 2002 on OEI's website. GLNPO believes their procedures will enable them to comply with
these guidelines and it is GLNPO's goal to implement these guidelines as appropriate throughout the
program. Implementation of the requirements specified in these guidelines will be administered through
GLNPO's quality system. Specifically, the Information Quality Guidelines will be implemented through
the Communications and Reporting Team. The Team Leader for the Communications and Reporting
Team will serve as the Divisional Tracking Contact and a Primary Consultant for this initiative. The
Team Leader will be supported by the Document Control Coordinator, whose role at GLNPO was
established this year (see Section 5.1). GLNPO's Quality Manager will serve as a IGQ primary
consultant and also as the IQG Trainer. Training on IQGs will be included in the training course,
Overview of GLNPO's Quality System, discussed in Section 3. GLNPO will report on the status of this
implementation in the QA annual report and workplan.
5.3.1 STANDARD OPERA TING PROCEDURES FOR PRE-DISSEMINA TION REVIEW
As part of the implementation of IQGs, GLNPO is developing standard operating procedures for
pre-dissemination review of GLNPO documents subject to the guidelines. These procedures will include
an approval process of pertinent documents by the GLNPO Director. The GLNPO Director may request
that other GLNPO staff with applicable experience, such as Team Leaders and the GLNPO Quality
Manager, participate in the review of particular documents, as he deems necessary. Formal peer review,
as discussed in Section 7.3, also may be part of the pre-dissemination review procedures. Currently,
GLNPO plans to track pre-dissemination review in GLNPO's Project Tracking Database described in
Section 2.6.
5.3.2 STANDARD OPERATING PROCEDURES FOR REQUEST FOR CORRECTION
GLNPO is developing standard operating procedures for requests for correction (RFC) pertaining
to GLNPO documents. A response to an RFC will be processed within 90 days of receipt. If a correction
is made, the GLNPO Director will provide signature approval of the correction. If the correction is
denied, substantiation to defend the decision will be signed by the GLNPO Director. Currently, GLNPO
plans to track requests for correction in GLNPO's Project Tracking Database described in Section 2.6.
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Section 6
Information Management
EPA's Office of Environmental Information (OEI) manages EPA's information technology
policy, infrastructure, and oversight of Federal and Agency information technology statutes, regulations
and standards. With Agency Directive 2100, Information Resources Management Policy Manual, EPA
established a policy framework for information management at EPA. This manual defines information
resources management as encompassing activities associated with planning, budgeting, organizing,
directing, and controlling information. GLNPO's efforts to manage environmental information will
comply with Agency Directive 2100 and employ this manual and other guidance and planning documents
developed by OEI. In addition, all information management system development, enhancement, and
modernization efforts comply with the most recent versions of the System Design and Development
Guidance (EPA Directive 2182, April 30, 1993) and the Operations and Maintenance Manual (EPA
Directive 2181, April 1990) available from the Office of Environmental Information. The IRM policy,
standards, guidance and planning documents are listed on OEI's website.
As GLNPO's information needs expand, the Office must develop and maintain hardware,
software, and information systems that efficiently support GLNPO environmental information collection
activities and are compatible with Federal and State agencies. GLNPO's Information Management and
Data Integration (IMDI) Team leads development and implementation of GLNPO's information
management policy.
6.1 GLNPO INFORMATION MANAGEMENT SYSTEM
The IMDI Team provides leadership and support to GLNPO and other involved parties in the
storage, access, and retrieval of Great Lakes environmental information. The IMDI Team is responsible
for:
*• defining GLNPO information management policy,
*• developing and maintaining information management systems (e.g., hardware, software, and
networks),
*• ensuring conformance with EPA and Federal information management policy,
*• reviewing and processing hardware and software requests,
*• providing technical support to operate information management systems,
*• serving as the contact point for electronic data dissemination,
*• supporting specialized processing requirements (GIS, remote sensing), and
*• providing database administration and management.
The IMDI Team oversees and coordinates all information management activities at GLNPO.
The IMDI Team assists GLNPO project planners with communicating pertinent details of GLNPO's
Information Management Systems to parties involved in GLNPO-funded EICAA's and facilitating their
use. These systems are made available so that States, agencies, and organizations involved in GLNPO
EICAA's can implement them if desired.
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Most GLNPO employees transfer and retrieve information electronically through the use of
personal computers (PCs). GLNPO PCs are linked to a number of communications packages. All
GLNPO PCs are linked through local area networks (LANs). This allows a number of PCs to be grouped
together to provide a means for sharing information, applications, and equipment such as printers and
plotters.
Central to GLNPO's information management system is a computerized database system to
house environmental monitoring data. The system was developed and initially implemented to support
the Lake Michigan Mass Balance Study (LMMB) and is now supporting aspects of GLNPO's Base
monitoring program and other special studies. The Oracle-based system, the Great Lakes Environmental
Monitoring Database (GLENDA), was developed to provide data entry, storage, access, and analysis
capabilities to meet the needs of GLNPO staff, LMMB study modelers, and other potential users of Great
Lakes data.
Development of GLENDA began in 1993, based on the user requirements and logical design
from US EPA's STORET modernization project. The close association with STORET has limited the
duplication of effort common to database development projects, and ensures maximum portability to the
future central home of most environmental data. GLENDA was developed with the following guiding
principles:
^" True multi-media scope — water, air, sediment, taxonomy, fish tissue, fish diet, and meteorology
data can all be housed in the database,
>- Data of documented quality — data quality is documented by including results of quality control
parameters,
>- Extensive contextual indicators — ensures data longevity by including enough information to
allow future or secondary users to make use of the data,
>- Flexible and expandable — the database is able to accept data from any Great Lakes monitoring
project, and
>- National-level compatibility — GLENDA is compatible with STORET and allows ease of
transfer between these large databases.
During GLNPO's Water Quality Survey (WQS) of the Great Lakes in Summer 2000, GLNPO
began phasing in the use of an on-board GLENDA data entry system designed to capture data directly
into the database on a daily basis. The purpose of this pilot was to test the entry system as a means of
facilitating streamlined upload of survey data to GLENDA and dissemination of survey results to
interested parties. The data entry system is available on the Lake Guardian and also at GLNPO
headquarters. The data entry system can be used for real-time data entry or by entering data recorded on
hard-copy data forms. The system is designed to include real-time data entry checks to prevent analysts
or technical staff from entering 'nonsensical' values.
The WQS Chief Scientist has primary responsibility for assuring that all data gathered in the
survey are documented. Documentation includes raw instrument level printouts, summary bench sheets,
and electronic records generated on board ship and in the laboratories. All shipboard-generated strip
charts, bench records, and computer printouts are kept in a folder, indexed by station, until the remaining
samples are transferred to involved laboratories. All raw data are assembled and indexed by parameter,
by lake, and by survey leg. All onboard results will be recorded in the GLENDA data entry system, or on
hard-copy or soft-copy data forms for subsequent entry into the onboard system. These files will be
transferred to a CD or floppy diskettes.
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For extramural programs, GLNPO POs are responsible for obtaining all appropriate data derived
from GLNPO-funded EICAAs. At the time of project planning, the data reporting requirements,
including the type of data (raw, verified, QA/QC), and the media (paper, electronic, disk, tape etc.), must
be explicitly determined and documented in the quality system documentation. It is highly recommended
that all environmental monitoring data funded by GLNPO be reported according to the data reporting
standards (Section 6.3).
6.2 HARDWARE AND SOFTWARE REQUIREMENTS
The IMDI Team ensures that GLNPO is conforming to all Federal and EPA standards for
hardware and software and in-house information management systems. The Office of Environmental
Information develops standards for EPA data processing and telecommunications. They also provide
technical assistance and advice to EPA and State agencies concerning the acquisition and implementation
of information management technology. As part of this assistance, EPA developed an information
technology architecture road map that establishes the Agency's information technology portfolio, as
required under the Information Technology Management Reform Act of 1996. The road map forms the
basis for the selection and deployment of computing platforms and network connectivity between
computing platforms, as well as the software and related products that interconnect computing platforms.
GLNPO conforms with this road map when purchasing hardware and software. In addition, GLNPO
complies with the Delegation of Procurement Authority Guide to ensure that purchased software will
meet user requirements and will comply with the Office of Environmental Information standards. The
IMDI Team relies on guidance and planning documents developed by OEI on technology infrastructure
to purchase and manage information technology systems.
IMDI regularly conducts user needs assessments of GLNPO staff to identify when additional
infrastructure is needed. Once a need is defined, the IMDI solicits various vendors for software
demonstrations. Only vendors that comply with Agency information resources management standards
are solicited. The IMDI, as well as appropriate GLNPO staff, evaluate the software to determine its
performance and future capabilities. Prior to purchase, the IMDI Team fully evaluates software in terms
of its intended use. Software is selected on the basis of minimum performance standards and cost.
Software also may be developed in-house and may involve smaller, specialized information
systems that could include small databases, spreadsheets, and data entry tools. Many of these systems
are based on commercially-available software and may only be employed for short periods. In these
cases, the information system standards may not be applicable and may do little to ensure the quality of
those systems. GLNPO's graded approach applies to planning and documentation of software
development. The PO and the Branch Chief are responsible for identifying when such "minor"
information systems will be employed and documenting all efforts by the project staff to ensure their
quality. Project documentation should include a detailed description of the algorithm or software process
used in the project. For larger scope software development projects proper documentation must be
developed that includes:
*• hard-copy documentation of the software,
*• the developer's name,
*• the names of all current maintenance personnel,
*• intended use of the software package (capabilities & non-capabilities),
*• the detailed process used to verify the software, including test examples, and
*• software code with sufficiently detailed comments to ensure understanding by other analysts or
programmers according to EPA coding policy.
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A formal quality management process must be developed for complex software development
projects (e.g., mathematical models). Prior to initiation of these projects, GLNPO staff must prepare
planning documentation that includes a section devoted to the quality management of the software
system. The documentation should address the planning, budgeting, organizing, directing, and training
needs associated with the software development project. The planning documentation also should
address audits and tests of the software at various phases to assure the integrity of the software.
6.3 REPORTING STANDARDS
In order to be capable of utilizing information across GLNPO programs and between other EPA
Regions and laboratories, emphasis must be placed on improving information compatibility. The EPA
Data Standards Program is established and documented in EPA Directive 2100 Information Resources
Management Policy Manual. GLNPO adheres to this program and all mandatory Agency data standard
policies.
GLNPO devised reporting standards for data submissions for their EICAAs in accordance with
Agency policy. GLNPO's data standards are designed to ensure consistency in reporting and facilitate
data verification, data validation, and database development. GLNPO's data standard conforms to the
QA/QC codes as derived from EPA Order 2180.2 Appendix B. To date, GLNPO has developed
standards for the following data: air/water analyses, fish tissue, fish diet, and sediments. The latest
reporting standards are available at the following web page:
http://www.epa.gov/glnpo/lmmb/rptstds/index.html. This site will be updated periodically as the
reporting standards are changed. The reporting standards also can be requested from GLNPO for transfer
by disk or e-mail. Examples of GLNPO's data reporting standard and QA/QC codes are listed in
Appendix D.
The Field Reporting Standard contains information about the station visit, sample collection
activities, and results from in situ measurements and visual observations. Generally, it is used to record
information about what was collected, where it was collected, how it was collected, by whom it was
collected, and the results of field measurements and observations. The Laboratory Reporting Standard
contains information about laboratory samples and analyses. Generally, it is used to record information
about the analysis of field and QC samples and the results obtained from such analyses. To capture all of
this information in a logical and useful way, the Reporting Standard is broken into several files - most of
which are used only in special cases.
Data reporting requirements must be consistent with GLNPO and Agency information
management policy. POs are responsible for the format, quality and submittal of data derived from
GLNPO funded EICAAs. At the time of project planning, the type of data (raw, verified, QA/QC), and
the media (paper, electronic, disk, tape etc.) must be determined. A data submission is defined as a
logical combination of Reporting Standard files that are sent as a unit from an investigator to GLNPO.
Each submission is defined within a field delivery header file that contains a unique combination of
project code, sampling organization code, submission number, and version number. The submission
number and version number are assigned by the investigator for tracking purposes. The version number is
simply a control number that distinguishes a specific collection of data from older (or newer)
submissions of the same data. The data submission concept becomes important when an investigator
determines that he/she needs to replace a data submission that was sent previously to GLNPO. An
investigator easily can replace a data submission by sending an updated, complete data submission that is
identified with the same submission number as the original data but with an incremented version number.
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6.3.1 GLNPO LOCA TIONAL DA TA POLICY
IRM Policy Manual 2100 Chapter 13, requires geographic coordinates and associated method,
accuracy, and description codes (MAD) for all environmental measurements collected by EPA
employees, contractors, and grantees. This policy establishes the principles for collecting and
documenting latitude/longitude coordinates for facilities, sites, and monitoring and observation points
under Federal environmental programs. The intent of this policy is to extend environmental analyses and
allow data to be integrated based upon location, thereby promoting the enhanced use of EPA's extensive
data resources for cross-media environmental analyses and management decisions. This policy
underscores EPA's commitment to establishing the data infrastructure necessary to enable data sharing
and secondary data use. To facilitate the integration of data into these systems it is important that coding
of geographic coordinates and associated attributes be standardized. All GLNPO projects that include
data collection, habitat restoration, or other 'location dependant' activity are required to adhere to
GLNPO's Locational Data Reporting Format, both intramural and extramural. The GLNPO Locational
Data Reporting Format is compliant with the Region 5 and Headquarters Locational Data Policy and was
approved by the Region 5 Locational Data Manager. The GLNPO Locational Data Reporting Format is
available on the GLNPO web page http:\\www.epa.gov/glnpo/ fund/ldp.html.
6.4 INFORMATION SECURITY
GLNPO has developed an information security plan to manage security controls of GLNPO's
LAN, named Great Lakes National Program Office Binational and Partner Network (GLNPO.net). The
purpose ofGLNPO.net is to provide a development/production Internet site available for web projects
that are binational or regional in scope without putting the US EPA network at risk. The system supports
50 developers, including GLNPO, Region 5, US Army Corp of Engineers, State and Environment Canada
staff and their contractors, as well as EPA grantees and cooperators. GLNPO is responsible for
development and implementation of the system. The users that view pages on the site range from
GLNPO partners (using "user IDs" and passwords) to the public, who are directed to a particular URL,
depending on content. The system is located at in the Metcalf Federal Building in Chicago, Illinois.
The Information Security Plan is maintained by the Information Management and Data
Integration Team who are responsible for implementation of the plan. Specifically, Pranus
Pranckevicius1, the Team Leader, maintains the plan. A cover page of the December 2000 draft of the
Information Security Package is included in Appendix E that includes authorizations for the plan and the
table of contents for the Information Security Package. In the plan, GLNPO documents assignment of
responsibilities associated with the development and implementation of GLNPO's system security as
well as user responsibilities. GLNPO included in the plan the rules for accessing GLNPO.net and using
GLNPO data. The plan also includes information on training individuals to use the system and on
security awareness in general. GLNPO also details management of personnel controls for the system and
incident response activities. Confidentially sensitive data are not permitted on GLNPO.net. GLNPO is
developing this system in accordance with the following laws and regulations:
*• The Computer Security Act of 1987,
»• Privacy Act,
>• OMB Circular A-130, Management of Federal Information Resources,
*• EPA Information Resources Management Policy Manual, and
*• the Enterprise Technology Services Division LAN Operating Procedures Manual.
'Phone: 312-353-3437, E-mail: pranckevicius.pranas@epa.gov
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Section 7
Quality Planning
In order to accomplish its mission, GLNPO must effectively plan and implement environmental
information collection activities. It is GLNPO policy that collecting environmental data of adequate
quality for its intended use can only be achieved with systematic planning prior to initiation of an
EICAA. Further, GLNPO's quality management policy stipulates that planning processes must be
adequately documented. In accordance with GLNPO's graded approach the level of detail in planning
and documenting the planning process should be commensurate with the importance and intended use of
the work, available resources and unique needs of the organization. The following sections describe the
processes GLNPO uses to plan EICAAs and document the planning process.
7.1 PROJECT PLANNING AND SCOPING
Each year, GLNPO conducts planning meetings with local, State, Tribal, Federal, and
international Great Lakes stakeholders. From these annual meetings and through Agency direction, Great
Lakes environmental issues of concern are identified and funds are reserved for discretionary grants and
intramural activities to address these issues. GLNPO Teams then develop and distribute requests for
proposals (RFPs) regarding these issues of concern. Once pre-proposals are submitted, GLNPO Teams
review them and identify those that are of interest to GLNPO to fulfill their mission. The Quality
Management Team assists the POs in distributing to potential grantees a copy of EPA QA/R5, EPA
Requirements of Quality Assurance Project Plans and pertinent examples of quality system
documentation from similar past projects. Potential grantees are encouraged to submit a full proposal
based on applicable sections of QA/R5. In this way, the quality planning process begins at the earliest
phase of the EICAA and the probability this process will provide added value to the EICAA is greatly
increased.
Systematic planning is essential to managing quality and should be conducted by a group with
sufficient knowledge to ensure that the activities undertaken will result in a product with the level of
quality needed for its intended purpose. The planning steps listed below are one suggested approach that
GLNPO POs and task leads can use to plan effectively and meet the requirements of GLNPO's quality
system. Although the exact questions illustrated in the planning steps may not need to be answered, the
issues behind the questions need to be addressed before proceeding with the activity. A common
approach to answering these questions, and thus to planning, is to assemble a team or a work group of
knowledgeable staff to address these details. At GLNPO, the functional teams often fulfill this role with
their Management Advisor and additional participating staff with a firm technical grasp of the subject
matter. In addition, staff that control the budget and those that manage any contractors or grantees
involved in the effort also should be included in the group. It is also essential that the team consult with
a member of the Quality Management Team to ensure that GLNPO's quality system requirements are
being addressed.
Step 1 - Problem Identification
*• What is the problem and how does it relate to GLNPO's mission? (e.g., verbal statements of the
general problem can be are narrowed into succinct questions that are unambiguous and can be
answered with specific data.)
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Step 2 - Project Purpose
»• What is the primary purpose of the activity and why is it important to proceed?
»• Are environmental data required?
»• What is the schedule for completion and is it driven by forces outside of GLNPO (e.g., legislative or
judicial deadlines)?
Step 3 - Project Design
»• What are the quality requirements for the activity?
»• What is the allowable level of uncertainty? (i.e., quantify the level of uncertainty that will be
allowed while still being able to answer the project questions outlined in Step 1.)
Step 4 - Resource Requirements
»• What activities must be performed?
»• What staff members are needed to complete these activities? Are these staff available? If not, what
other options exist (e.g., will staffing limitations dictate achievable project quality or project design?)
»• What resources and materials are needed to complete project activities? Are these
resources/materials available? If not, what other options exist (e.g., will resource limitations dictate
achievable project quality or project design)?
»• If data are required, what kind of data are needed, how will they be collected, and what are the
quality requirements?
»• Can we achieve these requirements within the schedule, using the available technical, financial, and
staffing resources?
Note: Quality management is an integral part of any GLNPO EICAA and should be included as a
budget line item.
Step 5 - Roles and Responsibilities and Project Products
*• Who is the customer and what are their expectations (e.g., senior EPA management, the public,
Congress, the regulated community, etc.)?
*• What types of information does the customer need (i.e., summary information, detailed trends,
graphs, GIS etc.).
*• Who is the supplier and what are their responsibilities? (i.e., personnel responsible for management,
planning, budgeting, reporting, etc. must be clearly identified in the planning documentation.
Step 6 - Performance Measures
*• How can we measure the success of the project (e.g., through quantitative measures, surveys, peer
review, etc.)?
Note: The measure of success is an important aspect of the assessment and corrective action phases of
the project, which are discussed in Section 9.
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Upon completion of these steps, it should be clear whether the questions can be answered with
the resources available and at the desired level of uncertainty. The project leads may have to choose
between adding more resources or having less confidence in the data. In summary, systematic planning
involves determining and clearly defining your objective and developing a detailed plan to address the
objective that considers available resources that are allocated to support it.
At GLNPO, the Quality Management Team is involved in planning EICAAs. The Team will
assist POs and task leads by identifying necessary quality management activities for a given project. The
Quality Management Team generally assists in:
»• developing quality system documentation,
*• implementing the quality system,
*• conducting audits and system reviews,
*• providing technical support to determine needed QC samples, and
*• assessing data quality.
In order to ensure that quality system requirements are considered for every EICAA, the Quality
Manager reviews every expenditure for extramural projects to determine if quality system documentation
and peer review are needed for that project to meet GLNPO's quality policy. A Project Inventory and
Approval Form (Appendices H and I) accompanies assistance (grant and IAG) packages and serves to
document the Quality Manager's determination of whether quality system documentation or peer review
are needed for a given project. GLNPO senior management does not approve of expenditures without a
project inventory and approval form containing the approval signature of the Quality Manager or his
designee from Quality Management Team. This is a key part of GLNPO's quality system because it is
the first step in the inventory of all EICAA's at GLNPO. The Quality Management Team and POs can
employ a series of checklists to assist them in making this determination. The Quality System
Documentation Checklist provided in Appendix F can be used to guide POs, line management and the
Quality Management Team through the process of planning a project while complying with GLNPO's
quality system.
If the project requires quality system documentation, the Quality Management Team begins
tracking the EICAA by entering information regarding the project into GLNPO's tracking database,
QATRACK. The Quality Management Team uses QATRACK to provide the status of EICAAs and
associated required quality system documentation to GLNPO staff and management at monthly meetings.
In addition, the database assists the Quality Management Staff in notifying POs when required
documentation is overdue. Once the documentation is overdue, GLNPO's Protocol to Address Missed
Requirements is implemented (Appendix M). The protocol addresses the failure of funded entities to
provide quality system documentation and other required work products on schedule by providing a
general framework for action including how and when to involve management. This protocol involves
notifying the PO of the delinquency through a written memo from the Quality Management Team. An
example of this memo is provided in Appendix N.
7.2 DOCUMENTATION
Another critical component of GLNPO's quality system is that the planning process must be
documented. The information generated during the six planning steps listed above forms the basis of the
quality system document. GLNPO recognizes that documentation of the project is of utmost importance
and must address all phases of the EICAA. While the data from a project may be technically sound, lack
of proper documentation can make the data suspect and the defense of a project difficult if not
impossible. Documentation must address all phases of the EICAA.
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Quality system documentation can be developed in a variety of forms. Two of the most common
forms are a quality management plan such as this one, and a quality assurance project plan for an activity
involving the collection of environmental data. The reference section of this document contains the titles
of the latest guidance and requirements documents for those plans that are available from the EPA
Quality Staff. These plans do not apply to every decision-making activity that may be conducted by or
for GLNPO, and may apply poorly to others.
Therefore, GLNPO's quality system explicitly provides for a graded approach to the
documentation of environmental data collection activities. The most stringent approach to such
documentation is a quality assurance project plan as described in EPA QA/R-5. However, the planning
process may be used to specify when other forms of documentation will be employed. For example,
GLNPO funds a variety of grants to States, Tribes, and public and private organizations that advance its
mission. Some of those grants involve the collection of environmental data, but are for small dollar
amounts that simply cannot support the production of elaborate quality system documents such as quality
assurance project plans. Other intramural activities involve the collection of environmental data that are
never going to be used to make an environmental decision, but rather are used as a means to raise public
awareness of environmental issues or provide educational outreach. Therefore, these data collection
activities need not be documented in a format as formal as a quality assurance project plan. For other
projects, a document addressing all components of QA/R-5 is appropriate. For example, GLNPO has
developed a QAPP in accordance with EPA QA/R-5 for the base monitoring program that is updated
annually by POs and the Quality Management Staff. GLNPO's graded approach will rely on EPA R-5 to
form the basis for quality system documentation and will require documentation that addresses applicable
components of EPA QA/R-5 for all GLNPO-funded EICAAs.
According to the EPA Quality Manual for Environmental Programs, the eight elements of the
planning process listed in Exhibit 6 must be documented. The specific details of these elements are
addressed in the six suggested planning steps described in the previous section. Whatever form of
documentation is used, it must address these elements of the planning process.
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Exhibit 6
Eight Elements of the Planning Process That Must Be Documented
1. Identifying the project manager, the sponsoring organization and the responsible
individual within that organization, the project personnel, the "customers" and
"suppliers," and describing their involvement in the project.
2. The project goal, objectives, and the questions and issues to be addressed
3. The project schedule, resources and budget, and milestones, and any applicable
requirements (e.g, regulatory or contractual requirements)
4. The type of data needed and how those data will be used to support the project
objectives
5. How the quantity of data needed was determined and how the criteria for the quality of
the data were determined
6. How, when, and from where data will be obtained, including existing data. Identifying
any constraints on the data collection process
7. Specification of the activities during data collection that will provide the information
used to assess data quality (i.e., field or laboratory quality control operations, audits,
technical assessments)
8. How the data for the project will be analyzed, evaluated, and assessed against their
intended use and the performance criteria established above.
It is important to establish efficient communications among all project participants to ensure
smooth operation of all phases of an EICAA. A "Project Organization" section in the quality system
documentation helps to establish the lines of communication.
For projects or tasks involving environmental data performed through grants and cooperative
agreements (40 CFR Parts 30, 31, and 35), the planning process must identify the appropriate level of
quality system documentation that will be employed. The documentation must be reviewed and
approved by the relevant POs, task leads, and the Quality Management Team prior to the start of
EICAAs.
When working with States that have GLNPO-approved QMPs, approval authority for quality
system documentation for EICAA's under their supervision is delegated to the State. The PO can review
quality system documentation to ensure that the technical requirements of the project are clearly met;
however, approval of the quality system is delegated to the State. The States often request that GLNPO
review and provide input on quality system documentation. GLNPO routinely offers its support and is
committed to working with States in the Great Lakes Region to effectively plan and implement EICAAs.
For projects that employ data from other sources (i.e., secondary data), the level of quality
system documentation should be commensurate with the nature of the data and the decision to be made.
The Office of Environmental Information is developing guidance on using data from other sources.
When the guidance is finalized, GLNPO will review it and, if appropriate, incorporate the guidance into
the procedures for assessing the quality of secondary data. In the meantime, GLNPO will continue to use
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the planning process described in this plan to identify when secondary data will be used, to establish
acceptance criteria for the data, and to outline the manner and extent to which secondary data will be
verified. The project staff will continue to employ professional judgement to ensure that the data meet
the needs of the project.
Once quality system documentation is submitted, the PO reviews the document to ensure that the
technical requirements of the project are clearly met. If approved by the PO, the quality system
documentation is forwarded to the Quality Management Team for review and approval. The Team
employs formal procedures for logging, tracking, and maintaining all submitted documents as described
in Appendix S. As part of these tracking procedures, the Quality Management Team uses a Quality
System Documentation Status and Tracking Sheet (Appendix O) to monitor fulfillment of documentation
requirements. All submitted documents are maintained by the Team in both hard-copy and soft-copy
(when available). The Team conducts a standardized review using a checklist to document the
acceptability of all applicable requirements and determines that quality requirements are:
*• included and acceptable,
*• included and not acceptable,
»• not included,
»• not applicable.
The checksheets, one for reviewing QAPPs, and one for reviewing QMPs, can be found in Appendix J.
After completing the review, the Quality Management Team provides a cover memo and check sheet
with comments to the PO detailing conclusions, recommendations and any required revisions. When
revisions are needed, the documentation is resubmitted and reviewed by the Team. GLNPO's Quality
Manager is available to assist involved parties with understanding and meeting the quality system
requirements and often participates in meetings or conference calls if requested by the PO.
As part of project planning, project leaders will develop timelines for the development, review,
and completion of required documentation. Appropriate reviewers of documentation also should be
identified as part of the planning process. Documents will be archived as detailed in Section 5.
7.2.1 GLNPO's GRADED APPROACHES TO QUALITY SYSTEM DOCUMENTATION
GLNPO implements a graded approach to quality system documentation that is consistent with
the decision being made. Every expenditure that GLNPO makes towards EICAAs and every intramural
project that collects environmental information driven by environmental decisions should have quality
system documentation commensurate with the importance of the question that is being addressed. A
small environmental education grant will not need as much documentation as a large monitoring program
involving several agencies and large-scale sampling. At a minimum, all projects that collect
environmental information should default to quality system documentation in accordance with
EPA Requirements for Quality Assurance Project Plans (EPA QA/R-5), addressing all applicable
components. Typically, GLNPO will accept a QAPP as sufficient documentation of the quality system.
In other cases, when providing funds to one organization that will in turn provide those funds to another
organization, a QMP is required. However, QMPs are not required for all of GLNPO's extramural
projects. Available resources also are a consideration, such as when working with Tribes. In these cases,
GLNPO will work more closely with organizations that do not have the infrastructure to support a large-
scale quality system.
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The Quality Manager, in conjunction with Project Officers, will determine the appropriate level
of quality system documentation for each project. In the past, GLNPO has used a four-tiered project
category approach to determine the detail necessary for QAPPs (GLNPO QMP, October 1997, Revision
03). These categories have been replaced by the eleven categories listed in the table below.
Categories of Environmental Information Collection and Assessment Activities
State agencies
Consortium grants
Cluster grants
Repeating projects of similar scope
Existing data/modeling
Tribal grants
Sediment assessment
Habitat/Ecosystem restoration
Ambient monitoring and research demonstration
Pollution prevention and Environmental education
Volunteer monitoring
Quality system documentation at the program-level is most
often required (QMPs)
Quality system documentation at the project-level is most
often required (QAPPs)
Suggestions and requirements for quality system documentation for each of these categories are
discussed in detail in the following sections. In some cases, categories identified as most often requiring
project-level documentation may be better suited to program-level documentation. This will be
determined on a case-by-case basis by GLNPO's Quality Manager. Quality system documentation for
programs is discussed in Section 7.2.1.1 and quality system documentation for projects is discussed in
Section 7.2.1.2. Examples of GLNPO's graded approaches for quality system documentation are
included in Appendix K
7.2.1.1 QUALITY SYSTEM DOCUMENTATION FOR PROGRAMS
GLNPO often funds other organizations that conduct or oversee EICAAs. These activities fall
into four general categories: 1) consortium grants, 2) cluster grants, 3) state agency funding, and 4)
funding repeating projects with similar scope and common elements. Consortium grants include large
studies with multiple grantees and sub-grantees addressing a single issue. For example, GLNPO issued a
consortium grant for Lake Erie where many experts were assembled to address the single issue of oxygen
depletion in the lake. Cluster grants generally involve one organization that administers multiple
projects. GLNPO regularly administers funds to States around the Great Lakes covering a multitude of
projects. Repeating projects of similar scope are a unique type of agreement. They include projects
where GLNPO works with an approach or standard operating plan developed by a lead agency, such as
The Nature Conservancy, where multiple projects are administered individually through various grantees.
For groups that are working with GLNPO in one of these categories, GLNPO expects the grantee
organization to have a quality system in place that is consistent with ISO 9001 and EPA Order 5360.1
A2. For major programs, EPA Requirements for Quality Management Plans (EPA/QA R-2) must serve
as the basis for quality system documentation. A list of components of a quality management plan
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A true functional value-added quality system
is not driven by approved documentation, but
more so, by the activities implemented on a
daily basis that enhance the quality of the
environmental decision.
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according to EPA QA/R-2 is provided in Table 1 at the end of this section. All of the project planning
documents, quality system documentation, and products of the projects are subject to GLNPO review and
approval. Quality system documentation for specific projects including QAPPs and SOPs must be
provided to GLNPO upon request to facilitate a technical system or a quality system audit. Many POs at
GLNPO request project-specific documentation in order to get an idea of the technical direction and
adequacy of specific projects, but they do not serve in an approval capacity.
Once a quality management plan is
approved, GLNPO will not micro-manage
organizations or agencies. GLNPO
understands that time is needed to implement
a true functioning quality system. GLNPO
will request quality system documentation
only for specific instances in order to review
technical correctness and will not review
documentation as a matter of course.
GLNPO's Quality Management Team will
provide training on development of quality systems as requested.
GLNPO administers funds to eight States around the Great Lakes: Minnesota, Wisconsin,
Michigan, Ohio, Indiana, Illinois, Pennsylvania, and New York. Currently, GLNPO only recognizes the
quality management system implemented by the State of Wisconsin. For states that have obtained EPA
Regional approval of their quality management system, GLNPO will recognize this approval, as long as
the scope of GLNPO activities that the State is involved in is addressed in the quality system. GLNPO is
interested in working with each State to develop an approved quality system and will offer assistance
when requested.
Quality management resources often are lacking at the State level. In these cases, GLNPO may
provide assistance for reviewing quality system documentation and other quality management areas as
requested by the State. In some cases, grants to State agencies fit into the cluster grant category and are
termed performance partnership agreements.
The quality system documentation requirements for the remaining three program-level categories are
further described below.
7.2.1.1.1 CLUSTER GRANTS
GLNPO issues a large number of grants, many of which are quite small, and the administrative
burden can exceed GLNPO's ability to effectively oversee and implement the projects. GLNPO uses
cluster grants to coordinate groups of grantees and sub-grantees. For example, GLNPO often administers
one cluster grant to the Great Lakes Commission which provides grants to 3 different agencies. In these
agreements, GLNPO expects that project-level quality system documentation will be reviewed by a
trained quality manager. The principle investigator also can review the quality system documentation for
technical correctness and GLNPO encourages this procedure. The quality system documentation for
cluster grants must include detailed information regarding the review procedures for project-level quality
system documentation. This detailed information should discuss what is expected in project-level quality
system documentation, the procedures that will be implemented to review the quality system
documentation, and the roles and responsibilities of involved parties regarding the review and approval
of the project-level quality system documentation. The GLNPO Quality Management Team can assist
grantees with training for reviewing quality system documentation and can assist in the review, if
requested. Grantees should conduct a quality system audit at least once during the project, preferably
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close to the start of the project. Details of how this assessment will be conducted and who is responsible
for ensuring that it is conducted also should be included in the quality system documentation. Cluster
grants require regular coordination among quality managers at grantee and sub-grantee organizations and
GLNPO.
7.2.1.1.2 CONSORTIUM GRANTS
Consortium grants are similar to cluster grants, except that groups of grantees are focusing on
one key question. The quality system documentation requirements are the same as for cluster grants,
however, the focus is on the over-arching quality management plan, whereas for cluster grants, the focus
is on project-specific quality system documentation. Other than this difference in focus, the quality
system documentation requirements are the same for consortium grants as they are for cluster grants. The
Great Lakes Commission Quality Management Plan is provided in Appendix K as example
documentation for a consortium grant.
7.2.1.1.3 REPEATING PROJECTS OF SIMILAR SCOPE
GLNPO works with various non-governmental organizations that conduct projects of similar
scope with a variety of grantees. For example, GLNPO often enters into agreements with The Nature
Conservancy. In implementing projects, each grantee uses standard procedures developed by The Nature
Conservancy that include:
1. Data dictionary,
2. Data reporting procedures,
3. Data use and security restrictions, and
4. Standard operating procedures for species identification and abundance measures.
GLNPO encourages organizations that implement these types of projects to develop a single quality
system document to cover all of these types of activities in order to save resources needed to develop and
review multiple quality system documents. A quality management plan at the national level will ease the
administrative burden at the local level. GLNPO will assist these organizations in developing program-
level quality system documentation. A generic quality assurance project plan for the repeating projects
also maybe appropriate. In these cases, additional event-specific documentation, such as a sampling and
analysis plan that documents specific information that is not addressed in the generic QAPP, may be
sufficient
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Table 7-1. Required Elements in a Quality Management Plan (QMP)
Elements
A1
A2
A3
A4
A5
B1
B2
B3
C1
D1
D2
D3
E1
F1
G1
H1
11
J1
Management and Organization
Organization's QA Policy
Statement
Distribution List
QA Manager/Staff Authorities
Technical Activities/Programs
Quality System Components
Principle Components
Tools for Implementing
Components
Personnel Qualifications & Training
Procurement of Items & Services
Procurement Document Approval
Solicitation Response Approval
Documents and Records
Computer Hardware and Software
Planning
Implementation of Work Processes
Assessment and Response
Quality Improvement
Requirements
Give an overview of
State the importance of QA and QC, general objectives/goals of Quality System,
and policy for resource allocation for the Quality System.
Distribution list for the QMP revisions and final guidance.
Discuss the responsibilities and authorities of QA Manager and other QA staff;
document independence of QA Manager
Discuss specific programs that require quality management controls, where
oversight of extramural programs is needed to assure data quality, and where
internal coordination of QAand QC activities needs to occur.
Describe the organization's quality system
Discuss the principal components (quality system documentation, annual
systems review, management assessments, etc.) which comprise the quality
system
QMPs, management assessments, technical assessments, systematic planning,
SOPs, QAPPs, and data quality assessments
Describe organization's training policy, processes, and documentation.
Describe the roles, responsibilities, and authorities of management and staff
which pertain to all appropriate procurement documents or extramural
agreements
Describe review and approval procedures for procurement documents
Describe review and approval processes of all applicable responses
Discuss procedures for documents and records
Describe QA and QC processes for the use of computer hardware and software
to support environmental data operations
Describe systematic planning process for environmental programs, discuss
QAPP process, and discuss organization's secondary data policy
Describe developing and implementing procedures, planned procedures, and
controlling measures
Describe how and by whom assessments of environmental programs are
planned, conducted, and evaluated; and the processes by which management
determines assessment activities and tools appropriate for a particular project
and expected frequency of use
Describe how organization will detect and prevent quality problems and ensure
continual quality improvement; communication of expectations about quality
improvement to staff
GLNPO added note:
The above elements are the minimum requirements for a QMP, and therefore, should be
used during the QMP development.
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7.2.1.2 QUALITY SYSTEM DOCUMENTATION FOR PROJECTS
GLNPO's environmental information collection activities typically fall into the seven categories
listed in 7.2.1. Quality system documentation for these activities will vary according to the
characteristics of the specific projects in accordance with GLNPO's graded approach, such as the impact
of the decision, the cost of the project, and the project objective. The required documentation for all the
following categories must be based on EPA QA/R-5. A list of the components of quality system
documentation according to EPA QA/R-5 is provided in Table 2 at the end of this section. However, all
components will not apply to all projects. Suggestions for quality system documentation for the seven
general categories are further described below.
7.2.1.2.1 EXISTING DATA/MODELING
GLNPO environmental information activities can involve modeling and the use of existing data.
Project planning for modeling projects is important in order to ensure that the model is scientifically
sound, robust and defensible. EPA's Quality Staff has developed a guidance document (EPA QA/G-5M)
that can provide assistance in planning and implementing modeling projects. Additionally, EPA's
Quality Staff also has developed a draft checklist, Using Data from Other Sources - A Checklist for
Quality Concerns, for use in planning modeling and other projects using existing data. The checklist
includes the following steps (adapted by GLNPO):
1. Identify the decision you are making or the project objectives.
2. Identify the data and information from outside sources proposed for the project.
3. Prioritize data needed for decision (i.e., what are the most important pieces of data).
4. Determine whether the data have any constraints affecting their use in the new project.
5. Determine where the acquired data will be used in the decision-making process.
6. Scrutinize data for quality concerns pertinent to the intended use.
7. Document your analysis plan.
8. Execute your analyses and document the outcome appropriately.
A past GLNPO modeling project, Lake Erie Total Phosphorus Loads, illustrates how the
checklist can be used for planning and documenting a project (see Appendix K). An example of quality
system documentation for modeling, Quality Assurance Project Plan for Lake Erie Total Phosphorus
Loads: 1996 to 2000, also is provided in Appendix K. In addition, an example of quality system
documentation for secondary data, Quality Assurance Project Plan for Great Lakes Sediment Data
Support, is provided in Appendix K.
In general, for modeling projects and projects that use existing data, the expertise of personnel
involved in the modeling effort is of utmost importance. Curriculum vitae and resumes of key personnel
should be included with the quality system documentation. Roles of involved personnel and their
expertise is critical due to the subjective components of model development and application. Experts
that are needed to provide related technical assistance, such as chemists, also must be identified in the
documentation.
For modeling projects and other projects that use existing data, a QAPP based on the applicable
components of EPA QA/R-5 would be considered sufficient to define the appropriate quality system. For
modeling projects, the importance of having all of the quality system documentation finalized prior to
initiation of the project is not as great as it is for other types of projects (such as when cost constraints
involved with sampling efforts require thorough documentation prior to sampling). GLNPO understands
that for modeling projects, much of the planning will depend on the outcome of the initial efforts that
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involve evaluating existing models and available data. For this reason, the documentation could be
developed in steps, given the evolution of the modeling effort. Documentation with as much detail as
practical should be developed prior to initiation of the project. Thorough quality system documentation
that addresses other components of the project could be developed in the mid-stages of the project, once
the initial efforts have provided the final direction of the project. For example, the roles and
responsibilities of involved personnel must be documented in detail prior to the initiation of the modeling
effort. In addition, the criteria for evaluating data for acceptability into the model also must be
documented. Another important component to include in the initial documentation is the methods that
will be used to evaluate, assess, and test software and other modeling tools.
For development of new models, comparison of the output to existing models would provide a
good assessment tool for the new model. Documentation should discuss these planned activities in
addition to planned sensitivity testing of the model and identification of key variables.
7.2.1.2.2 TRIBAL GRANTS
GLNPO administers grants to several Tribes in the Great Lakes region. In some cases, Tribes are
characterized by less infrastructure and available resources than many other organizations that work with
GLNPO. However, in order to conduct effective projects and make good use of resources, quality
assurance issues need to be addressed. Tribal grantees should use EPA QA/R-2 and EPA QA/R-5 as the
basis for quality system documentation, while considering the tenet behind the graded approach
discussed throughout this document. In fact, tribal grants are one of the driving forces behind the graded
approach. GLNPO will implement a flexible approach when reviewing quality system documentation for
tribal grants, however, as stipulated for GLNPO's graded approach, quality activities for a given project
must be commensurate with the decision that is being made. GLNPO will offer training to tribal grantees
when requested and will provide examples of quality system documentation from similar grants when
available. GLNPO also encourages coordination among Tribes, so that quality management activities for
one project can serve as an example for similar projects.
7.2.1.2.3 SEDIMENT ASSESSMENT
GLNPO conducts three types of sediment assessment projects: 1) assessments which include
screening level and site-specific assessments, 2) remediation projects, and 3) post-remediation projects.
For GLNPO's sediment assessment grants, GLNPO requests that grantees develop quality system
documentation that addresses all components of EPA QA/R-5. Typically, remediation projects will
involve more detailed documentation than the other types of projects. Sediment assessment projects use
the NOAA Query Manager Database to store and retrieve sediment data. Sediment assessment projects
stipulate data reporting in a format specific to the Query Manager Database and the quality system
documentation should describe activities that implement this data standard. Details of the database are
described in, The Quality Assurance Project Plan for Great Lakes Sediment Data Support included in
Appendix K. Sediment assessment projects also can involve existing data and the quality system
documentation issues described in Section 7.2.1.2.1 are pertinent for these projects. Examples of quality
system documentation are provided in Appendix K and include: for assessment, The Quality Assurance
Project Plan for Cuyahoga River Old Channel Assessment', for site-specific assessment, The Quality
Assurance Project Plan for Raisin River Sediment Sampling in FY2002: A Follow-up to the 1997
Sediment Remediation Project', and for remediation projects, Quality Assurance Project Plan for
Kinnickinnic River Sediment Sampling in FY2002.
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7.2.1.2.4 HABITAT/ECOSYSTEM RESTORATION MANAGEMENT
Activities supporting habitat and ecosystem restoration management generally fall into three
categories: assessment, restoration, and protection. Of these three categories, habitat assessment projects
generally require the highest level of data quality. For habitat restoration management projects, quality
system documentation should identify the expertise needed to support the project. Expertise involving
species identification, detailed knowledge of site conditions, and optimal site conditions associated with
target species is very important in habitat restoration and management activities and should be discussed
in the quality system documentation. Species identification training for staff supporting the project also
should be included and often involves picture or photo keys that staff can use in the field or the lab.
Because some of the habitat measures involve subjective measurements, such as percent dieback, photo
documentation may be helpful. Random checks on personnel involved in these subjective measures, such
as a side-by-side comparison of measurements against qualified personnel can enhance the confidence in
the data and if implemented should be discussed in the documentation. Other important considerations
for habitat projects that should be included in the documentation include use of geographical standards
and proper handling of ecologically sensitive data such as those that involve endangered species. An
example of quality system documentation for habitat restoration management, Quality Assurance Project
Plan for Controlling the Spread of Swallow-wort, is provided in Appendix K.
7.2.1.2.5 AMBIENT MONITORING AND RESEARCH DEMONSTRATION
GLNPO's ambient monitoring activities include programs on a variety of environmental media
such as the open lake, fish, and atmospheric toxics monitoring, and are described in Section 1.3. For
these long-term projects, comparability of data over time is critical because many projects involve data
sets representing more than 30 years. Comparability among other monitoring agencies, such as the
Canadian government in the air toxics monitoring program, also is critical. For these programs, GLNPO
stipulates development of quality system documentation that addresses all components of EPA QA/R-5.
For GLNPO's fish monitoring program, sampling is conducted on a voluntary basis and therefore
additional oversight is needed and must be addressed in quality system documentation.
7.2.1.2.6 POLLUTION PREVENTION AND ENVIRONMENTAL EDUCATION
GLNPO is involved in many environmental education and pollution prevention projects and the
primary function often is to build stakeholder involvement and consensus for environmental initiatives.
These projects also function to empower other organizations by providing information and training. In
some cases, these projects involve compiling existing information to develop outreach materials for
educating the public and organizations. These projects typically do not require as much documentation
as many of the other GLNPO projects. The quality system documentation may focus on objectives of the
project more than data quality. In general, quality management activities often are discussed in
qualitative, as opposed to quantitative, terms. For some projects, an original proposal may serve to
document the quality system sufficiently. In other cases, a quality management narrative that describes
the objective of the project and the quality management activities that will be undertaken to ensure a
successful project would suffice.
7.2.1.2.7 VOLUNTEER MONITORING
GLNPO administers several projects that involve volunteer monitoring. The quality system
documentation for volunteer monitoring depends on the primary reason for collecting the information. In
some cases, the primary reason is to educate and promote public stewardship of local environments. In
these cases, quality system documentation may be a scaled-back version of EPA QA/R-5 and should
focus on interactions with the individuals involved in monitoring and how they can be educated about the
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environmental data they are gathering. In other cases, the monitoring is being conducted for a large study
and the data will be used to characterize environmental conditions and make decisions. In these cases,
standard operating procedures and training are of primary importance. The project may involve such
quality management activities as a minimum performance test at the completion of volunteer monitoring
training, to increase the confidence and quality of the data. Data collection forms are an important
component of all volunteer monitoring activities and should be included in the systematic planning of
projects and also in quality system documentation. Oversight of the project by qualified personnel is an
important aspect of volunteer monitoring. Safety is of utmost importance in volunteer monitoring
projects and must be considered in the documentation. For projects where a high level of data quality is
needed, audits may be required at a high frequency to ensure proper procedures are being followed.
A series of fact sheets, guidance documents and methods for volunteer monitoring have been
developed by EPA's Office of Wetlands, Oceans, and Watersheds (OWOW). GLNPO's QA Manager
believes OWOW has done a very nice job of defining QA issues and considerations for quality system
documentation. An OWOW website, http ://www. epa. gov/owow/monitoring/vol.html, includes, The
Volunteer Monitor's Guide to Quality Assurance Project Plans, in addition to a variety of other guidance
documents and methods. GLNPO encourages individuals involved in volunteer monitoring projects to
review these materials.
Table 7-2. Required Elements in a Quality Assurance Project Plan (QAPP)
Elements
Requirements
PROJECT MANAGEMENT
A1
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
Data Quality Objectives
for Measurement Dat
Special Training
Requirements/
Certification
Documentation and
Record
Title and approval sheet.
Document control format.
Distribution list for the QAPP 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.
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Elements
Requirements
MEASUREMENT/DATA ACQUISITION
B1
B2
B3
B4
B5
B6
B7
B8
Sampling Process
Designs (Experimental
Design)
Sampling Methods
Requirements
Sample Handling and
Custody Requirements
Analytical Methods
Requirements
Quality Control
Requirements
Instrument/Equipment
Testing Inspection and
Maintenance
Requirements
Instrument Calibration
and Frequency
Inspection/Acceptance
Requirements for
Supplies and
Consumables
B9 Data Acquisition
Requirements
(Non-direct Measurements)
B10
Data Management
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 routine (real-time) QC procedures that should be associated with each
sampling and measurement technique. List required QC 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.
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.
ASSESSMENT/OVERSIGHT
C1
C2
Assessments and Re-
sponse Actions
Reports to Management
Describe the assessment activities needed for this project. These may include DQA,
PE.TSA, MSR/PR/RR
Identify the frequency, content and distribution of reports issued to keep management
informed.
DATA VALIDATION AND USABILITY
D1
D2
D3
Data Review, Validation,
and Verification
Requirements
Validation and
Verification Methods
Reconciliation With Data
Quality Objectives
State the criteria used to accept or reject the data based on quality.
Describe the process to be used for validating and verifying data, including the chain-of-
custody for data throughout the lifetime of the project.
Describe how results will be evaluated to determine if DQOs have been satisfied.
GLNPO added note: The above elements are the minimum requirements for a QAPP, and therefore,
should be used during the QAPP development.
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7.2.2 QA ANNUAL REPORT AND WORKPLAN
The Quality Manager may submit a QA Annual Report and Workplan (QAARWP) to GLNPO line
management and EPA Quality Staff. This report summarizes the quality management activities for
previous years and describes the activities planned for the coming year. The QAARWP generally
includes:
*• a general status of the quality management program including strengths, weaknesses, successes, and
problems;
»• an assessment of the adequacy of the QMP and recommended changes;
»• a list of quality management training for GLNPO personnel;
»• a list of quality system documentation and SOPs developed over the last year;
»• a list of the major EICAAs undertaken in the last year that require quality system documentation, the
status of the documentation, including budgeting and time estimates for the development of
outstanding documents;
»• a list of the projects that were audited and reviewed in the preceding year; and
*• a list of the major projects for which audits are planned for the coming year.
The report is submitted in conjunction with the GLNPO Team Workplans. In addition, the Quality
Manager develops periodic reports that include categories for progress, problems and resolutions,
reports, and a list of activities scheduled for the next period. These reports are presented to the
management team during the monthly team briefings. The Quality Manager will immediately report any
serious QA problems to line management as they arise. Serious matters requiring immediate attention
will be reported directly to the GLNPO Office Director.
7.3 PEER REVIEW
EPA has a formal Peer Review Policy, described in the EPA Peer Review Handbook. In
accordance with this policy, GLNPO requires that peer review be incorporated into the planning process
for all major, scientific or technical work products. This documented, critical review is an in-depth
assessment of the assumptions, calculations, extrapolations, alternate interpretations, methodology,
acceptance criteria and conclusions pertaining to the major scientific or technical work product and of the
documentation that supports this product. The determination that a scientific or technical product is
"major" is based on whether it meets at least one of the following criteria:
*• Does it support major regulatory decisions or policy/guidance of major effect?
*• Does it establish a significant precedent, model or methodology?
*• Does it address controversial issues?
*• Does it focus on significant emerging issues?
*• Does it have significant cross-Agency/inter-Agency implications?
*• Does it involve a significant investment of Agency resources?
*• Does it consider an innovative approach for a previously defined problem/process/methodology?
*• Does it satisfy a statutory or other legal mandate for peer review?
GLNPO POs and the Quality Management Team can use the checklist, GLNPO Required Peer
Review Information, (Appendix L) to assist them in complying with Agency peer review policy. Because
GLNPO manages approximately 100-200 assistance agreements and contracts each year it is not practical
to complete this checklist for all of these projects because most of them do not need peer review. The
alternative approach that GLNPO utilizes meets the criteria in the Peer Review handbook and entails
Project Inventory and Approval Forms (Appendices H and I) that are reviewed by the QA manager, who
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recommends to GLNPO's Director whether the project needs quality system documentation or peer
review. The peer review recommendation made by the QA manager is based on the questions posed in
Appendix L and a final determination is made by the Director on approval of the package and
corresponding documents. A new database, GLNPO's Projects Tracking Database (see section 2.6),
which will be implemented in the last quarter of FY2002, will track the peer review status for each
project. This database will include the contracts and in-house projects that are not subject to grant project
inventory and approval forms and sign-offs. Peer review determinations will be sanctioned by the office.
Those projects requiring peer review, including those to be peer reviewed via a refereed, scientific
journal, will be entered into the EPA Science Inventory which tracks national peer review products and
science activities. The Peer Review Leader will be given GLNPO's checklist #2, or will fill out the
appropriate fields in GLNPOs Projects Tracking Database. The progress of the peer review planning
process can be tracked by entering comments or attaching documents to section 14 of the National
Database, and when the peer review is completed the database manager will update the entry in the
National Database. Those projects which do not need peer review, but are scientific or technical, are
entered into the Science Activity section of the National Database. The project summaries for each fiscal
year are added to the appropriate GLNPO science category, which are: Atmospheric Deposition
Monitoring Program, Coastal Wetlands Monitoring and Indicator Development, Emerging Issues, Fish
Contaminant Monitoring, Great Lakes Limnology Monitoring, Great Lakes Planktonic and Benthic
Monitoring Program, Habitat Protection/Restoration, Invasive Species Program, Lake Michigan Mass
Balance, Pollution Prevention, Sediment Assessment and Monitoring, and State of the Lakes Ecosystem
Indicators.
7.4 H EALTH AND SAFETY ISSUES
The health and safety of project participants is of primary importance to GLNPO and health and
safety issues must be addressed in the planning process for all GLNPO-funded EICAAs. For assistance
agreements, GLNPO will address safety requirements within the special conditions sections of written
agreements.
GLNPO has a designated Health, Safety, & Environmental Compliance Coordinator and Health and
Safety Team who are responsible for managing health and safety issues at GLNPO. GLNPO has
developed a comprehensive document outlining health and safety issues pertinent to GLNPO EICAAs
titled, Health, Safety, & Environmental Compliance Manual. This manual was updated in May 2002.
GLNPO conducts many EICAAs on the GLNPO research vessel R/V Lake Guardian and the R/V
Mudpuppy. The manual specifies comprehensive requirements for medical monitoring and safety
training for any GLNPO employee that will be working on our vessels. The R/V Lake Guardian and the
R/V Mudpuppy also accommodate other EPA personnel, contractors, and researchers implementing
GLNPO-funded EICAAs. The vessels each contain a copy of the current safety manual and GLNPO
requires that all individuals working on the vessels review the manual. To facilitate this review, GLNPO
provides training on the manual as part of its mandatory onboard training conducted each Spring prior to
GLNPO's Water Quality Surveys. Safety inspections of the vessel occur annually or more frequently if
hazardous situations are discovered. A report of the inspection is distributed to the GLNPO Health and
Safety Team who then address any safety infractions. GLNPO's Health, Safety, & Environmental
Compliance Coordinator is responsible for reviewing the Health, Safety, & Environmental Compliance
Manual and revising it as needed to address all issues related to GLNPO EICAAs.
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Office safety also is addressed in the GLNPO Health, Safety, & Environmental Compliance Manual
as well as in the Region 5 Safety Manual (2000). GLNPO participates in the Region 5 evacuation
procedures and has personnel identified to assist the Region 5 Safety Manager in an emergency. The
Region 5 Safety Manager and the GLNPO Safety Manager annually inspect the GLNPO offices and
vessels for hazardous conditions. The GLNPO Safety Manager will inform GLNPO employees of any
specific hazards in their office space.
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Section 8
Quality Implementation of Work Processes
Implementation of a quality system is as important as planning the system. For intramural and
extramural projects, the GLNPO PO is responsible for ensuring that tasks supporting EICAAs are
performed according to plan. GLNPO's processes for ensuring implementation of the quality system
during EICAAs are detailed below.
8.1 INTRAMURAL ACTIVITIES
As described in the previous section, EICAAs require detailed, comprehensive planning and
documentation of the planning process. These planning documents should detail operational tasks of an
EICAA such as:
*• Field sampling *• Sample analyses
*• Sample handling and shipping *• Sample archiving
*• Sample preparation *• Data reporting
GLNPO ensures that these tasks are carried out according to plan by ensuring all relevant parties
have copies of the planning documentation. It is the PO's responsibility to identify these relevant parties
and distribute the planning documentation. The PO is also responsible for ensuring all involved parties
understand the plan and their specific roles and responsibilities. This is often accomplished through a
"kick-off or "all-hands" meeting prior to the initiation of an EICAA. Because GLNPO often employs
functional teams in the planning process and the individuals on the team will be subsequently involved in
the tasks involved in the project, this provides an added benefit to GLNPO where the involved staff are
fully informed of the purpose of the project and the project design.
For example, in support of GLNPO's base monitoring program, the monitoring team coordinates
meetings of all involved staff in January or February as they develop their schedule for the year. These
meetings include an assessment and subsequent revision of the QAPP for the survey and the SOP
document, Sampling and Analytical Procedures for GLNPO's Open Lake Water Quality Survey of the
Great Lakes, to capture small changes to the program. The schedules developed in the meetings are
communicated to all parties involved in the survey through distribution of an "information package."
The package contains a detailed survey schedule, sampling plan, and logistical information. In addition,
onboard training is conducted prior to the survey. The training includes a review of health and safety
issues, an overview of the survey schedule, a detailed review of SOPs, and information regarding
location of current documents including all SOPs, planning documentation, and safety manuals. In this
way, the PO ensures all involved parties are aware of the project purpose, plan, and their roles and
responsibilities as outlined in the planning documents.
8.2 EXTRAMURAL ACTIVITIES
To ensure tasks are being performed in accordance with the project plan, the PO has regular
communication with investigators. For example, for all GLNPO-funded EICAAs, the grantee prepares
periodic (generally semi-annual or quarterly) reports on the status and progress of activities. For larger
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scale or long-term EICAAs, the PO also conducts site visits, in accordance with government policy, to
view tasks in progress. As needed, the PO is available to provide technical and logistical support to the
investigator.
The investigator is required to submit SOPs with their quality system documentation or prior to
initiating EICAAs. Any revisions to SOPs or quality system documentation must be approved by the PO
prior to implementing the changes. The investigator is responsible for ensuring personnel are trained in
all SOPs and laboratory and field operations according to the requirements in the quality system
documentation. During review of the quality system documentation, the PO and Quality Management
Team attempt to identify additional procedures that would benefit from development and implementation
of SOPs . If additional SOPs are deemed to be necessary, the PO can request development and submittal
of these SOPs prior to initiation of the EICAA. SOPs are discussed further in Section 2.4.
To assist POs in obtaining the required work products on schedule, the Quality Management
Team provides reports to the PO listing outstanding work products, associated due dates, and the review
and approval status of these reports. As necessary, the Quality Management Team assists the PO with
implementing the Protocol to Address Missed Requirements (Appendix M). This protocol is discussed in
detail in Section 7.
For extramural projects, GLNPO's relationship to external parties is maintained through the PO.
The PO is the only person who has the power to accept or reject the product from an EICAA that is being
funded by GLNPO. Although the Quality Management Team is intimately involved in the EICAA, they
function to assist the PO in effectively implementing the EICAA. For example, all correspondence
regarding the project is addressed to the PO, who must then communicate the information to the grantee.
The Quality Management Team does not work directly with the funded party without the PO's
involvement. Responsibility of the PO for implementing the system and they have final authority for
determining activities of the grantee.
8.3 COMMUNICATION
Due to the multitude of external parties involved in GLNPO projects, communication is critical
to the success of GLNPO EICAAs and accomplishment of the mission. The Quality Manager attends
monthly meetings with GLNPO management and presents a written report on the progress and status of
quality system activities for all ongoing EICAAs. In most cases, the Quality Management Team will
copy Management Advisors on all internal and external communications for projects under their
responsibility. Communication between the Quality Management Team and all GLNPO staff also is
fostered through the quality system training provided by the Team.
8.4 DISPUTE RESOLUTION
Implementation of quality management activities may sometimes result in disagreements among
involved parties. When these disputes occur, resolution will be sought at the lowest management level.
GLNPO staff will attempt to resolve the dispute through discussion and negotiation. Final resolution will
be made by GLNPO's Director when negotiations do not resolve the issue.
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Section 9
Quality Assessment and Response
Quality assessments are used to determine the effectiveness of a quality system in meeting its
goals — in GLNPO's case, in ensuring that environmental information is of adequate quality for its
intended use. An assessment is a formal evaluation of performance relative to pre-determined standards.
Once an evaluation is conducted and documented, a response is implemented that provides corrective
actions to improve performance where necessary. A variety of tools are available to assess
environmental information collection activities including: audits, data quality assessments, quality
systems audits, peer reviews, technical reviews, performance evaluations, and technical systems audits.
These assessments are the principal means used by EPA to determine compliance and to control systems
in a real-time manner to improve performance. This section describes GLNPO's use of these assessment
tools.
9.1 QUALITY SYSTEMS AUDITS AND TECHNICAL SYSTEMS AUDITS
Quality systems audits (QSAs), previously termed management systems reviews, are on-site
evaluations by internal or external parties to determine if the organization is implementing a satisfactory
quality management program. They are used to determine the adherence to the program, the
effectiveness of the program, and the adequacy of allocated resources and personnel to achieve and
ensure quality in all activities. Internal QSAs are conducted by GLNPO senior management. GLNPO-
funded entities also may undergo QSAs lead by GLNPO's Quality Manager. External QSAs are
conducted by EPA Quality Staff to determine compliance of GLNPO's program with this QMP. The
QSA includes reviews of:
*• adherence to the GLNPO quality management plan,
*• procedures for developing project quality objectives and other acceptance criteria,
*• procedures for planning EICAAs,
*• procedures for developing and approving quality system documentation,
*• the quality of existing quality system documentation,
*• procedures for developing and approving standard operating procedures (SOPs),
*• procedures, criteria, and schedules for designing and conducting audits,
*• tracking systems for ensuring that the quality management program is operating and that corrective
actions disclosed by audits have been taken,
*• the degree of management support,
*• responsibilities and authorities of the various line managers and the Quality Manager for carrying
out the quality system,
»• the level of financial resources and personnel devoted the implementing the quality system, and
»• existence of appropriate quality system documentation and its conformance with the requirements of
the quality management plan.
To achieve the objectives of a QSA, the review should be conducted by an individual somewhat
independent of the organization, but still with a "stake" in seeing improvement. Because GLNPO
cooperates with many agencies, an individual from one of these agencies could lead an internal QSA.
The leader could then build a review team composed of individuals from GLNPO senior management
that would assist in the planning, scheduling, and implementation of the review. Prior to the audit, the
review team should develop an audit plan that defines the scope, purpose, and details of the review as
discussed in Section 9.5.
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The Quality Management Team will coordinate periodic QSAs of specific GLNPO functional
teams, depending on the number and importance of the projects being conducted by a Team. For
GLNPO's base monitoring program, the Quality Management Team will conduct an QSA on at least one
component of the program every year (e.g., limnology, fish monitoring, atmospheric monitoring, etc.) and
more frequently if serious deficiencies are identified. The review should occur between the months of
March and April, at the start of the Spring Survey.
Results of all QSAs coordinated by GLNPO are presented in reports to GLNPO management, the
Quality Manager, and EPA Quality Staff. The format for these reports is discussed in Section 9.5. For
all identified deficiencies, the review teams will develop proposed corrective actions and will discuss
them in the report. These corrective actions will become goals as part of the Quality Manager's
performance appraisal. In addition, the Quality Manager will detail the progress on these corrective
actions at management meetings, during Quality Manager performance reviews, and in subsequent
QAARWPs.
Technical systems audits (TSAs) are qualitative on-site evaluations of all phases of an EICAA
(i.e., sampling, preparation, analysis). These audits can be performed prior to or during the data
collection activity, in order to evaluate the adequacy of equipment, facilities, supplies, personnel, and
procedures that have been documented in the quality
system documentation. Because a TSA is most
beneficial at the beginning of a project, GLNPO will
schedule audits at the initiation phase of an EICAA,
when possible. GLNPO will perform a QSA, site visit,
or TSA for the most high-profile EICAA's (i.e., those
that support an important decision). The number and
frequency are dependent on the length of the project,
the importance of the project objectives, and the
evaluations of prior audits. GLNPO will conduct
TSAs on two or more GLNPO grants or contracts that involve EICAAs each year. Selection of these
grants and contracts will be proposed by the Quality Manager an sanctioned by the Quality Management
Team Management Advisor (GLNPO's Director).
Audits will be scheduled by the PO and tracked by the Quality Manager. The Quality Manager
can assist in facilitating audits at the request of the PO. In addition, the Quality Manager can participate
in audits at any time, to evaluate auditing procedures. The PO, in conjunction with the Quality
Management Team, is responsible for developing an audit plan (section 9.5) and documenting audit
results (section 9.7).
9.2 PERFORMANCE EVALUATIONS
Performance evaluations (PEs) are a means of independently evaluating data quality and the
variability associated with the overall measurement system or a distinct phase of the measurement
system. This is accomplished through the analysis of samples of known composition and concentration.
These samples can be introduced into the measurement system as blind samples where the identity and
the concentration are unknown to the analyst. These samples can be used to evaluate bias and precision
and to determine whether DQOs or MQOs associated with a given project have been satisfied. PEs also
can be used to determine inter- and intra-laboratory variability over the course of long-term projects, and
to evaluate laboratories prior to contract awards.
(SLNPO's value-added assessments
focus on improvement of the data
collection process through direct
involvement of the technical team
members in the assessment response.
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PEs are required for projects involving important decisions or where multiple parties are
involved in data collection and data comparability is an issue. At times, PE samples maybe of interest to
a PO but appropriate reference material from reliable sources may not be available. If time permits, the
PO, in conjunction with the Quality Management Team, can coordinate development of reference
samples from a bulk source. The samples are characterized by an laboratory, independent of the project,
through analysis of a statistically valid number of replicates and then used as reference material. GLNPO
participates in PE programs that apply to its EICAAs and provide information regarding data quality. For
example, GLNPO participates in several PE programs coordinated by the National Laboratory for
Environmental Testing in Ontario. GLNPO distributes information regarding pertinent PE programs to
grantees, states, and other involved parties and encourages participation. As part of the systematic
planning, POs should consider the use of PE samples.
9.3 PROJECT ASSESSMENTS
In order to conduct efficient audits, POs in conjunction with the Quality Management Team
should thoroughly plan the audit and document the plan. The audit plan document is not a major
undertaking and in most cases will be a one page table or report. However, the document represents
thoughtful and concise planning for an efficient and successful audit. The audit plan should be made
available to the organization audited, with adequate lead time to ensure that appropriate personnel and
documents are available for the audit. An audit plan for any type of audit will typically include the items
listed in Table 9-1.
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Table 9-1. Items to be Included in Project Assessments
Item
Project title
Audit number
Date of audit
Scope
Purpose
Standards
Audit team
Auditees
Documents
Timeline
Description
GLNPO project title
Year and number of audit can be combined; 2001-1, 2001-2
Date audit is scheduled
Establishes the boundary of the audit and identifies the groups and activities to be evaluated. The
scope can vary from general overview, total system, to part of system, which will effect the length of
the audit.
Why the audit is being conducted and what the audit should achieve.
Standards are the criteria against which performance is evaluated. These standards must be clear
and concise and should be used consistently when auditing similar facilities or procedures. The use
of audit checklists is suggested to assure that the full scope of an audit is covered. An example
checklist for an analytical laboratory audit can be found in Appendix P.
Team leader and members and their affiliation.
People that should be available for the audit from the audited organization. This should include the
Program Manager, Principal Investigator, organizations QA Representative, and other management,
and technicians as necessary.
Documents that should be available for the audit to proceed efficiently. Too often documents are
asked for during an audit, when auditors do not have the time to wait for these documents to be found.
Documents could include QMPs, QAPPs, SOPs, GLPs, control charts, raw data, QC data, previous
audit reports, etc.
A timeline of when organizations (auditors/auditees) will be notified of the audit for efficient scheduling
and full participation of all parties. The timeline also may include the schedule for the opening
briefing, data collection, exit briefing, and draft report orother product.
9.4 ASSESSMENT IMPLEMENTATION
After the audit plan has been developed, the auditee is notified prior to conducting the on-site
visit, to inform the auditee about the audit including its scope, purpose, and logistics. During this initial
contact, certain information can be requested such as the auditees organizational structure, SOPs, GLPs,
control charts, etc., that will help to efficiently implement the audit. Mutually acceptable audit dates
should be identified so that the appropriate staff are available during the audit period.
During the actual audit, there should be an initial interview with the audit team and the auditees,
in order to restate the scope and purpose of the audit, and develop a detailed schedule that is acceptable
to all involved parties. The schedule should include a list of the operational phases of the EICAA that
will be observed and time for debriefing activities.
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During the observation phase of the audit, one must be aware of one's own perceptions (a good
job to one auditor maybe a sloppy job to another). Three concepts (Arter, 1989) to consider in order to
persuade the audited organization that the auditor's perception of the facts is useful include:
*• Present items and facts that will satisfy the needs of the audited and auditing organizations. Make
a contribution. Show how the facts affect the product or service.
*• Ignore or downplay mildly disturbing things. Do not nitpick. Strive to answer the "So what? "
response.
*• Pay attention to significant things. Chronic or persistent problems and weaknesses, along with
trends, will get the auditee 's attention.
The Six Steps to the Basic Observation Interview
(as explained by Arter, 1989)
O Put them at ease. Give the auditee an opportunity to size you up and lower the natural sense of anxiety.
& Explain your purpose. Tell the auditee what you want and why you are asking the questions. Most people will
express a desire to share information once it is known why it is wanted.
© Find out what they are doing. Use open-ended questions (e.g., "what do you do as soon as you get the
sample; and then what happens.") The checksheet described in Appendix P can then be used during the
auditees response to fill in the "yes/no" answers.
v Analyze what they are doing. Once you have heard the words, analyze what they mean. You may want to
repeat the process and "think out loud" which will force you to put the facts in perspective and in a logical
arrangement.
© Make a tentative conclusion. Conclusions of that phase of the EICAA can be made. If the initial analysis
indicates that all is well, let the person know; they will continue to perform well with recognition from an outsider.
If there is a deficiency, give the auditees an opportunity to produce additional factual evidence to show that you
have made the error.
Explain your next step. Conclude the discussions and let the person know what's next. It is important to
remember that people want to know: (1) how they did in the interview, and (2) whether they are finished.
The six steps listed below are presented in Arter's book, Quality Audits for Improved
Performance (1989) along with additional details of all phases of an audit. A reference copy is available
from the GLNPO Quality Manager and is a suggested source of good information.
9.5 DATA QUALITY ASSESSMENTS
A data quality assessment (DQA) is used to evaluate the quality of specific data and determine if
this quality satisfies the stated project objectives of an EICAA. POs and the Quality Management Team
can use the guidance document, EPA QA/G-9, Guidance for the Data Quality Assessment Process:
Practical Methods for Data Analysis developed by EPA Quality Staff to assist them assessing data
quality.
Data quality assessments are generally conducted on the second TSA, at the completion of an
EICAA as part of a QA report, or at the request of a PO when concerns about data quality are identified.
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Based on TSA reports, the Branch Chief or the Quality Manager may suggest a DQA to the PO. The PO
is responsible for determining the need for a DQA and will be responsible for conducting this assessment
and developing subsequent reports. The GLNPO Quality Manager can assist in facilitating the
assessment as necessary.
Data quality assessments also can be made by conducting data review and verification. These
reviews typically focus on the QA data collected with the routine field data. Examples of QA analysis
checklists are provided in Appendix R.
In support of the Lake Michigan Mass Balance (LMMB) Study, GLNPO has developed "state-
of-the-art" data quality assessment approaches. For the study analytes, GLNPO determined quantitative
estimates of data quality in terms of three attributes: sensitivity, precision, and bias. In addition, GLNPO
developed a novel approach to assessing data quality, the percent variability due to sampling and
analytical measurement uncertainty. These estimates are described below.
Sensitivity The detection limit for each data set was estimated by the principal investigator. The
types of detection limits vary among investigators, although a commonly used approach
in LMMB was EPA's MDL (described at 40 CFR part 136, Appendix B that involves
analysis of seven replicate samples of known concentration). Sensitivity for each data
set is presented as a percent of field sample results above and below the detection limit.
Precision Precision was estimated through statistical analysis of analytical results for field and
laboratory duplicate samples. System precision, a measure of the precision for the entire
sampling and analytical procedure, was estimated through comparison of analytical
results obtained for routine field samples and their associated field duplicates.
Analytical precision, a measure of the precision of the laboratory analytical component
of the system, is a subset of the system precision, and was estimated through comparison
of analytical results obtained for routine field samples and their associated laboratory
duplicates.
Bias Bias was estimated through statistical analysis of analytical results for laboratory-spiked
routine field samples. System bias, a measure of the bias of the entire sampling and
analytical procedure, can be estimated through analysis of samples that have been spiked
in the field. Analytical bias, a measure of the bias of the laboratory analytical
component of the system, can be estimated through analysis of laboratory-spiked
environmental or blank samples.
Percentage of variability due to sampling
and analytical measurement uncertainty
The percentage of variability due to sampling and analytical measurement uncertainty is
estimated as the proportion of variability among all RFS results that can be attributed to
sampling and analytical measurement uncertainty. This measure is estimated as the
mean variance between field duplicate pairs as a proportion of the variance among all
RFS samples.
The quantitative estimates described above reflect data quality for a given entire data set
produced by a single laboratory. Study modelers have requested an interval estimate for single study
results. GLNPO is currently developing approaches to determine these interval estimates. GLNPO plans
to continue to develop approaches to assessing data quality and apply these approaches to all EICAAs.
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9.6 ASSESSMENT REPORTING
At the completion of an audit, the audit team will meet with auditees to discuss the results of the
audit and the next steps of the process. Positive and negative aspects of the EICAA will be discussed
between the audit team, management of the area audited, and, if necessary, technical personnel
performing the measurement activity. The review team should provide copies of the draft audit summary
and findings to all in attendance. The review team will discuss with the auditees, all necessary actions
needed to improve the measurement system.
The PO is responsible for reporting results from TSAs, DQAs, and PEs, even when the PO is not
the review team leader for the audit. For QSAs, the review team leader or an appointed designee is
responsible for preparing the report. These reports generally include:
»• audit title and number and any other identifying information;
»• audit team leaders, audit team participants and audited participants;
*• background information about the project, purpose of the audit, dates of the audit, particular
measurement phase or parameters that were audited, and a brief description of the audit process;
»• summary and conclusions of the audit and corrective action requirements; and
»• attachments or appendices that include all audit evaluation forms and audit finding forms.
A report should be completed within five working days of completion of an audit. The Quality
Manager and PO review TSA, DQA, and PE reports and document their review and approval through an
approval signature. The report is then filed with the Quality Manager. For QSAs, the audit team leader
and GLNPO Director review the reports and provide the approval signatures. The reports are filed with
the Director and Quality Manager. It is the responsibility of the review team leader to forward audit
reports to the appropriate project participants. Audit report have restricted distribution in order to foster
constructive working relationships. When significant concerns are identified during an audit, GLNPO's
Quality Manager or Director will schedule a meeting to address these concerns with the appropriate
parties.
9.7 RESPONSE ACTIONS
As mentioned above, the audit reports are discussed with the audited organization specifically noting
the corrective actions necessary to rectify and control the situation. Line management may be requested
to assist in problem resolution. For each audit finding, an audit finding response form will be developed
to track corrective actions. An example audit finding response form is provided in Appendix Q. These
forms will be included in the audit file retained by the Quality Manager. The PO (for TSAs, DQAs, PEs,
and QSAs of other organizations) or the GLNPO Director (for QSAs of GLNPO) are responsible for
ensuring compliance with the corrective actions. If major deficiencies are found, follow-up audits are
often required.
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Section 10
Quality Improvement
GLNPO's quality policy focuses on four operating principles: assistance, flexibility, value-
added, and continuous improvement. This QMP details GLNPO's quality system policy and processes,
many of which facilitate improvement of GLNPO EICAAs. For example, monthly management
meetings, quality system training, data quality assessments, and peer review activities provide
opportunities to identify areas for improvement that can be addressed in subsequent projects. GLNPO's
quality system is designed to facilitate identification and communication of these areas of improvement
to all GLNPO staff through meetings, training, and Quality Management Team reports. This section
describes GLNPO's process for realizing continuous improvement.
10.1 PROGRAM REVIEW
This QMP is approved by the GLNPO Director and all GLNPO Branch Chiefs, thereby
demonstrating their commitment to GLNPO's quality system. GLNPO management is responsible for
ensuring that GLNPO staff follow the guidelines of the quality system as documented in this QMP. This
is facilitated through regular quality system training, Quality Management Team monthly reports on the
status of quality system activities, and
maintenance of a central library that contains
GLNPO quality system documents and Agency ,.. j. • . n • i j
n J J. & J The input to management review shall include
guidance and requirements documents.
°T,TT,«, r, , • , ,, i • information on:
GLNPO s quality system is constantly being
evaluated for effectiveness. Line management re '
stakeholder feedback on the quality
system,
staff competence,
process performance, and
the status of preventive and corrective
actions.
and the Quality Manager meet quarterly to
discuss adherence to the QMP and to identify
where improvements can be made. For any
major quality system deficiencies, the Quality
Manager will develop proposed corrective
action, implement the action, and finally assess
its implementation. The Quality Manager will
summarize these meetings including the areas
for improvement and corrective actions in a quarterly report that is placed on GLNPO's LAN in the QA
directory. These reports also will be included in the QAARWP.
Management should always seek positive methods for ensuring adherence to policy; however,
management must implement corrective action procedures for staff that do not adhere to GLNPO or EPA
policy (e.g., obtaining approval of quality system documentation prior to implementation of an EICAA).
If staff members continuously disregard the policy, management should include this assessment in the
individual's performance evaluations.
The Quality Manager will review this QMP each year to determine if the document is relevant to
GLNPO's mission and reflects current procedures. Sections will be modified to address GLNPO's
evolving program and changing needs. GLNPO's quality system and this QMP also will be reviewed as
needed when changes in Agency policy or guidance occur. Revision of the QMP will be noted by the
change in revision number and the date of the revision included in the header information and in the
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Table of Contents. All revisions will be reviewed and approved by GLNPO's Director, Branch Chiefs,
and EPA Quality Staff before implementation. Upon approval, the QMP will distributed to all GLNPO
staff, along with a summary of the revisions
As discussed in Section 9, GLNPO invites Quality Staff to review the GLNPO's quality system
at any time or at a minimum of every two years. For all areas where deficiencies exist, the GLNPO
Quality Manager and line management will develop action plans for any deficiencies and inform EPA
Quality Staff of their progress to rectify these situations.
10.2 PROJECT REVIEWS
As mentioned above, a variety of tools that are implemented as part of GLNPO's quality system
facilitate improvement. Technical audits, peer reviews, and data quality assessments can improve the
quality for long-term EICAAs and for subsequent projects. In addition, to increase the effectiveness of
its EICAAs, GLNPO will conduct "wrap-up" meetings at the conclusion of as many EICAAs as possible.
These meetings should include as many project participants as practical. The meetings provide an
opportunity to review the quality system documentation to determine how the plan could be improved,
and how similar ongoing projects may benefit from addressing these areas for improvement. Preliminary
data quality assessments should be available to determine whether the quality system was successful in
controlling data quality to an acceptable level. The meetings serve to focus project planners and
participants on areas for improvement in all aspects of the EICAA including planning, field and
laboratory procedures, and appropriateness of the quality system. This project review will assist project
planners in identifying preventive actions that can be included in future EICAAs. The Quality
Management Team will document these meetings and maintain them on the GLNPO LAN so that these
"lessons learned" can be applied to all subsequent EICAAs where applicable.
&LNPO shall continually improve the effectiveness of the quality
management system through the use of the quality policy, quality
objectives, audit results, analysis of data, corrective and
preventive action, and management review.
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References
The EPA Quality Staff developed a series of documents describing the various requirements of
the overall EPA quality system as well as a series of guidance documents that describe how the system
can be implemented by EPA and by external organizations, including contractors and grantees. Many of
these documents are cited in the body of this quality management plan. All of the documents are
available from the Quality Staff web site in PDF format. The current uniform resource locator (URL) for
that web site is: www.epa.gov/quality
The Quality Staff also are working on a variety of new documents and revisions to existing ones,
and the reader is encouraged to check the web site above frequently for the latest available information.
Requirements Documents
All of the documents that describe formal quality requirements for EPA organizations are
defined "EPA Directives," and are policy documents. These include:
• EPA Order 5360.1 A2, May 2000, Policy and Program Requirements for the Mandatory Agency-
wide Quality System. This document describes the Quality requirements for EPA organizations that
produce environmental data.
• EPA Manual 5360 Al, May 2000, EPA Quality Manual for Environmental Programs. This
document describes the specifications for satisfying the mandatory quality system defined in EPA
Order 5360.1
Additional requirements documents apply to both EPA and external organizations. They are
designated with the letter "R" followed by a number. The documents that are available in final form at
this time are:
• EPA QA/R-2, March 2001, EPA Requirements for Quality Management Plans. QA/R-2 is the policy
document containing the specifications and requirements for Quality Management Plans.
• EPA QA/R-5, March 2001, EPA Requirements for Quality Assurance Project Plans. QA/R-5
replaces the 1980 document QAMS-005/80. This external policy document establishes the
requirements for QA Project Plans prepared for activities conducted by or funded by EPA. It is
intended for use by organizations having extramural agreements with EPA.
Guidance Documents
The Quality Staff have prepared a number of guidance documents that can assist in the
development and implementation of a suitable quality system for both EPA and non-EPA organizations.
The guidance documents are designated with the letter "G" followed by a number. The documents that
are available in final form at this time are:
• EPA QA/G-4, August 2000, Guidance for the Data Quality Objectives Process. QA/G-4 provides
guidance to help organizations plan, implement, and evaluate the Data Quality Objectives (DQO)
process, a systematic planning process for environmental data collection. It has a focus on
environmental decision-making for regulatory and enforcement decisions. The guidance presents a
step-by-step description of the DQO process.
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EPA QA/G-4D, September 1994, Data Quality Objectives Decision Errors Feasibility Trials (DEFT)
Software. QA/G-4D provides guidance for using the Decision Error Feasibility Trials (DEFT)
software to help organizations plan, implement, and evaluate the Data Quality Objectives (DQO)
process. The guidance presents a step-by-step description of the use of the PC-based DEFT software
DQO process.
EPA QA/G-4HW, January 2000, Guidance for the Data Quality Objectives Process for Hazardous
Sites. QA/G-4HW provides guidance to help organizations plan, implement, and evaluate the
statistics-based Data Quality Objectives (DQO) process as applied to hazardous waste sampling
activities. The guidance will present a step-by-step description of the DQO process and its
application to environmental remediation and waste management activities.
EPA QA/G-5, February 1998, Guidance on Quality Assurance Project Plans. QA/G-5 provides
guidance to help organizations develop Quality Assurance Project Plans that will meet EPA
expectations and requirements. The document provides a linkage between the DQO process and the
QAPP. It contains tips, advice, and case studies to help users develop improved QAPPs.
EPA QA/G-5M, April 2002, Guidance for Quality Assurance Project Plans for Modeling, peer
review draft. QA/G-5M discusses issues to be addressed in QA Project Plan elements in the context
of data use on modeling, emphasizing systematic planning, the use of existing data, hardware and
software configuration issues for modeling, and the graded approach.
EPA QA/G-6, March 2001, Guidance for the Preparation of Operating Procedures for
Quality-Related Operations. QA/G-6 provides guidance to help organizations develop and document
standard operating procedures (SOPs). The document contains tips, advice, and case studies to help
users develop improved SOPs.
EPA QA/G-7, January 2000, Guidance on Technical Assessments for Environmental Data
Operations. QA/G-7 provides guidance to help organizations plan, conduct, evaluate, and document
technical assessments for their programs.
EPA QA/G-9, July 2000, Guidance for the Data Quality Assessment Process: Practical Methods for
Data Analysis. QA/G-9 provides guidance for planning, implementing, and evaluating retrospective
assessments of the quality of the results from environmental data operations. Data quality
assessment is a statistically-based, quantitative evaluation of the extent to which a data set satisfies
the user's needs. This document is aimed at the project managers who are responsible for conducting
the environmental data operations and assessing the usability of the results.
EPA QA/G-9D, December 1997, Data Quality Evaluation Statistical Toolbox (DataQUEST).
QA/G-9D provides guidance for planning, implementing, and evaluating retrospective assessments of
the quality of the results from environmental data operations using the PC-based software,
DataQUEST.
EPA QA/G-10, December 2000, Guidance for Determining Quality Training Requirements for
Environmental Data Operations. QA/G-10 provides guidance to help organizations determine and
develop program-specific quality system training for all levels of management and staff.
No number, July 1999, Guidance on Quality Assurance Project Plans for Secondary Research Data.
Example Quality Assurance Project Plan requirements for secondary research data developed by the
QA Managers in EPA's National Risk Management Research Laboratory.
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EPA QA/G-0
EPA QA/G-3
Arter, D.R. 1989.
Byers, G.E. 1991.
EPA Order 5360.1A2
Proposed New EPA Order
ISO 9001:2000
Simes, G. F. 1989.
Taylor, J.K. 1987.
"EPA Quality System Description"
November 1997
"Guidance for the Management Systems Review Process "
January 1994
"Quality Audits for Improved Performance" ASQC Quality Press,
Milwaukee, Wisconsin. 93 pp.
"Quality Assurance Program in Monitoring and Research Strategy For
Forests" EPA 600/4-91/012. U.S. Environmental Protection Agency.
Las Vegas, Nevada.
"Policy and Program Requirements for the Mandatory Agency-wide
Quality System" U.S. Environmental Protection Agency
May 2000
Policy for Competition in Assistance Agreements, July 15, 2002
"Quality Management Systems - Requirements", International
Organization for Standardization", 2000.
"Preparing Perfect Project Plans" EPA/600/9-89/087. U.S.
Environmental Protection Agency, Cincinnati, Ohio.
"Quality Assurance of Chemical Measurements" Lewis Publishers,
Chelsea, Michigan. 328 pp.
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Glossary
bias
blind sample
comparability
completeness
data quality objective
environmentally-
related data
measurement quality
objective
overall data uncertainty
precision
project
quality assurance
quality control sample
representativeness
uncertainty
the level of agreement between an observed value and the "true" value of
a characteristic
a reference sample submitted to the analyst in such a manner that the
sample is known as a reference sample but its concentration is unknown
the similarity of data from different sources included in a given set of
data and the similarity of methodologies from related projects across the
regions of interest
the quantity of data that is successfully collected with respect to the
amount intended in the experimental design
user-defined criteria established for each parameter to evaluate usability
of data
Any laboratory or field data gathering activity or investigation involving
the determination of chemical, physical, or biological factors related to
the environment.
critical level which, if exceeded, is considered to append additional and
possibly unacceptable, measurement uncertainty to the corresponding
data
confounded population and measurement uncertainty occurring in a
sample
the level of agreement among multiple measurements of a characteristic
An organized undertaking or specified unit of investigation involving
environmentally related measurements
The total integrated program for assuring the reliability of monitoring
and measurement data.
any sample utilized by the analyst to check measurement conditions,
whose measurement is expected to fall within specific acceptance
criteria or control limits
the degree to which the data collected accurately represents the
population of interest
a measure of imprecision, bias, or other sources of variability in a given
value
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validation the process of determining the legitimacy of data for its state purpose,
involving internal consistency checks for outlier removal and definition
of levels of confidence
variability imprecision about a specific characteristic
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