£EPA
United States
Environmental Protection Agency
Office of Water
EPA821-R-09-001
February 2009
Office of Water
Quality Management Plan
February 2009
Revision 3
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Office of Water
Quality Management Plan Approvals
Michael H. Shapiro
Assistant Administrator (Acting), Office of Water
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Nanci E. Gelb
Deputy Assistant Administrator (Acting), Office of Water
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Director, Office of Wetlands, Oceans and Watersheds'*"'
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Director, American Indian Environmental Office
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Office of Water Quality Management Plan
Revision No. 3
February 2009
Page i of iv
Foreword
Most U.S. Environmental Protection Agency (EPA) activities involve some form of environmental data,
including the collection of data by EPA and the development of regulations requiring that others collect
environmental data. As a result, in 1979, EPA established a policy that requires all of its component
organizations to participate in an agency-wide quality system. Order CIO 2105.0, dated May 5, 2000, is
the most recent version of the policy and program requirements for the EPA quality system. The order
defines a quality system as:
"A structured and documented management system describing the policies, objectives,
principles, organizational authority, responsibilities, accountability, and implementation
plan of an organization for ensuring quality in its work processes, products, and
services."
The EPA quality system requirements have evolved since 1979 and now incorporate a national
consensus standard for quality systems authorized by the American National Standards Institute (ANSI)
and developed by the American Society for Quality Control (ASQC), ANSI/ASQC E4-2004, Quality
Systems for Environmental Data and Technology Programs - Requirements with Guidance for Use. The
Quality Staff in the Office of Environmental Information also develop documents that outline the specific
requirements for the EPA quality system and that provide guidance on its implementation (see the
reference section of this document).
Among other things, the EPA order requires that each organization prepare a document called a quality
management plan (QMP) that:
Documents the organization's quality policy
Describes its quality system
Identifies the environmental programs to which the quality system applies
This document is the quality management plan for the entire EPA Office of Water. It describes the quality
system used by the Office of Water and applies to all environmental programs within the Office of Water
and to any activity within those programs that involves the collection or use of environmental data. This
quality management plan supersedes the one approved by the Office of Water in 2002. It incorporates
many of the long-established procedures used to successfully manage quality in the Office of Water and
provides a practical approach to meeting the expanded _^^^^^^^^^^=^^^^^^^^^^=
goals of the EPA agency-wide quality system in the 21st
century.
A major goal of this plan is to provide a description of the
quality system that is of value to the users in the Office of
Water. The EPA Requirements for Quality Management
Plans (EPA QA/R-2) is the policy document containing the
specifications and requirements for quality management
plans and it includes ten elements of a quality system that
must be addressed in a quality management plan. The
Office of Water quality management plan addresses each of
the ten elements to the extent to which they apply.
However, to promote the understanding and use of the
plan, it has been written from the perspective of the Office
of Water staff who will implement it. In addition, the plan
avoids the use of jargon whenever possible and it is not
structured directly around the ten elements.
Ten Elements of a Quality System
All ten elements of a quality system are
addressed in this QMP
1. Management and Organization
2. Quality System Description
3. Personnel Qualifications and Training
4. Procurement of Items and Services
5. Documents and Records
6. Computer Hardware and Software
7. Planning
8. Implementation of Work Processes
9. Assessment and Response
10. Quality Improvement
It is anticipated that this Quality Management Plan will be further revised in 2009 to reflect the Agency's
new Quality Policy, EPA 2106.0, issued in October 2008.
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Office of Water Quality Management Plan Revision No. 3
February 2009
Page ii of iv
Table of Contents
Foreword i
Chapter 1 Introduction 1
1.1 Quality Policy 1
1.2 Graded Approach 2
1.3 Limitations of the Plan 3
1.4 How the Plan Affects You 3
1.5 How the Plan is Organized 3
1.6 Terminology 4
Chapter 2 Definition of Environmental Data 5
Chapters Organization and Management of the Quality System 7
3.1 Organization of the Office of Water 7
3.3 Organization of the Quality System 7
3.4 Program Management and Staff Responsibilities 11
3.4.1 Role of Management 11
3.4.2 Roles of Project Leads, Contract and Grant Project Officers, Delivery Order Project
Officers, and Project, Task Order, and Work Assignment Managers 13
3.4.3 Role of Technical Staff 13
3.5 Quality System Management and Staff Responsibilities 14
3.5.1 National Program Manager 14
3.5.2 Quality Assurance Manager 14
3.5.3 Quality Assurance Officer 15
3.5.4 Quality Assurance Coordinator 16
3.6 Delegated Programs - Responsibilities Outside of the EPA Headquarters Structure 17
3.6.1 Activities Delegated to EPA Regions 17
3.6.2 Delegated States, Tribal, Local, and Other Governmental Bodies 17
3.7 Assessing the OW Quality System 18
3.8 Dispute Resolution 18
Chapter4 Planning, Implementing, Evaluating, and Improving Quality 21
4.1 Planning Quality in Office of Water Activities 21
4.1.1 Planning Process 21
4.1.2 Planning Tools 22
4.2 Implementing Quality Management Activities 24
4.3 Evaluating the Results and Making Adjustments 25
4.3.1 Planning Assessments 25
4.3.2 Conducting and Documenting Assessments 25
4.3.3 Corrective Actions 26
4.3.4 Assessment Tools 26
4.3.4.1 Internal Peer Consultation 26
4.3.4.2 Formal Peer Review 27
4.3.4.3 Data Validation 27
4.3.4.4 Data Verification 28
4.3.4.5 Data Quality Assessment 29
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4.3.4.6 Technical System Reviews or Assessments 29
4.3.4.7 Performance Evaluation/Proficiency Testing 30
4.3.4.8 Quality System Assessments 31
4.3.4.9 Annual Program Review 32
4.3.5 Dispute Resolution 33
4.4 Quality Improvement 33
4.4.1 Encouraging Staff to Identify and Implement Improvements to Quality 33
4.4.2 Program-level Improvement 33
4.4.3 Project-level Improvement 34
Chapters Planning Documentation 35
5.1 Quality Assurance Project Plans 35
5.2 Equivalent Documentation 36
5.3 Documentation for Primary Data Collection 36
5.4 Documentation for Secondary Data Collection and Use 37
5.5 Information Quality Guidelines 37
5.6 Documentation for Contracts and Assistance Agreements (Grants and Cooperative
Agreements) 38
5.7 Preparation and Approval of Quality System Documentation 38
5.8 Standard Operating Procedures 40
5.8.1 Identifying Operations that Require SOPs 41
5.8.2 Preparation, Review, Approval, and Use of Office of Water SOPs 41
5.8.3 Revision and Removal of SOPs 42
5.8.4 SOP Format and Content 42
Chapter6 Management of Documentation and Records 45
6.1 Quality Assurance Records Schedules 45
6.2 Confidentiality 46
6.3 Review, Approval, and Release of Work Products 46
Chapter 7 Quality System Training 49
7.1 Office of Water's Quality System Training Program 49
7.2 Role of the Quality Assurance Manager 49
7.3 Training Requirements 50
7.4 Continuing Education and Refresher Training 50
7.5 Training for Grants and Contracts 52
Chapters Information Systems 53
8.1 General Support Systems and Major Applications 53
8.2 Compliance with Applicable Information System Standards 53
8.3 Compliance with EPA Data Standards 54
8.4 Office-wide Data System Coordination and Oversight 54
8.5 Other Information Systems 54
Chapter9 Procurement and Financial Assistance 57
9.1 Contracts 57
9.2 Financial Assistance 59
9.2.1 Assistance Agreements (Grants and Cooperative Agreements) 59
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9.2.2 Performance Partnership Agreements and Grants 61
9.3 Interagency Agreements 61
References 63
Requirements Documents 63
Guidance Documents 63
Other Reference Materials 65
List of Attachments
Attachment A Generic Quality Assurance Project Plan Checklist
Attachment B Three appendices from EPA's Contracts Management Manual Chapter 46 (Appendices
46.1A, 46.1B, and46.1C)
Attachment C Quality Assurance Review for Extramural Projects (Contracts)
Attachment D Quality Assurance Review Form for Extramural Projects (Contract WAs, DOs, and
TOs)
Attachment E Cincinnati Procurement Operations Division Work Assignment Review Checklist
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Chapter 1 February 2009
Page 1
Chapter 1
Introduction
The Office of Water is committed to ensuring the quality of all of its activities and decision-making
processes. The quality of our activities is essential to achieving the goals established for the Agency by
Congress under the Safe Drinking Water Act, the Clean Water Act, and other legislation aimed at
protecting the nation's aquatic resources; it also is essential for fulfilling the Clean and Safe Water Goal of
the Agency's Strategic Plan. This document is the quality management plan (QMP) for the Office of
Water and all of its component parts. This plan describes the management and technical practices that
are used to assure that the environmental data used by all programs within the Office of Water to support
decisions are of superior quality for their intended purpose. We refer to this collection of procedures and
activities as our "quality system." Our quality system is designed to provide decision makers in the Office
of Water with a practical framework for managing the quality of all activities within the Office. Quality
management is the part of an organization's overall management system that determines the
requirements for quality up front and implements the policies and procedures needed to ensure that the
quality requirements for the organization's products are continuously met. The Office of Water
recognizes that there cannot be a one-size-fits-all approach to every activity. Therefore, the basic tenet
of the Office of Water's quality system is that the level of effort needed to manage the quality of any
activity depends on:
The importance of the activity
The risk of a decision error
The schedule for completion
The available resources
This tenet is a guiding principle that applies throughout this quality management plan.
In addition to its commitment to quality in all of its activities, the Office of Water relies on environmental
data in its daily activities and decision-making processes. Accordingly, it is the Office of Water's goal that
environmental decisions are based on data of known and documented data quality, such that the
decisions are scientifically, and where necessary, legally defensible and able to withstand public scrutiny.
1.1 QUALITY POLICY
The Office of Water has established a quality policy that is based on the basic tenet and goal described
above and is in alignment with the Agency's Quality Policy, Information Quality Guidelines, and Peer
Review policy.12 The Office of Water quality policy provides a succinct statement of the scope of the
quality system and summarizes the components of the quality policy that guide implementation and
assessment of the quality system. The quality policy stresses the need for systematic up-front planning
and the use of a graded approach to quality management that conforms to the basic tenet listed above.
The Office of Water's quality policy is presented in Exhibit 1-1.
1 Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility and Integrity of Information
Disseminated by the Environmental Protection Agency, October 2002 (EPA/260R-02-008)
2 Peer Review Policy (and memo signed by the Administrator on January 31, 2006) (PDF) (4 pp, 261K)
and U.S. EPA Peer Review Handbook, 3rd Edition, EPA/1 OO/B-06/002 (PDF) (190 pp, 1.15MB), available
at http://www.epa.qov/peerreview/
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Exhibit 1-1
Office of Water Quality Policy
The quality system is not optional. It is a critical aspect of all activities in the Office of Water that involve
the generation and use of environmental data, and quality is built into these activities from the start. It applies
to activities conducted by the Office of Water, its contractors and grantees, and to those programs delegated
to States and Tribes.
All staff in the Office of Water have a responsibility for the quality of their work and of the
organization. The responsibility is fostered by clear communication of the goals and requirements of the
quality system to all staff, as well as appropriate quality-related training.
There is an individual identified within each organizational unit in the Office of Water who is the focal
point for the implementation of the quality system within that unit and whose quality system activities are
independent of the line management structure.
Quality is a critical responsibility of all levels of management within Office of Water and all
management personnel have identifiable roles in the quality system. Managers are responsible for ensuring
the allocation of funding for quality management activities, including intramural, extramural, and travel funds,
as well as funding for personnel and quality-related training.
Quality can only be achieved through systematic planning, assessment, and corrective action.
Management is responsible for ensuring that adequate staff and other resources are devoted to these aspects
of every project.
The importance of the project, the risk of a decision error, the schedule for completion, and the
available resources are used to establish the level of quality management applied to a given activity.
These considerations must be addressed and documented during the planning phase of the activity.
The quality of any environmental data or information used by the Office of Water must be assessed
(known) and documented, regardless of the source. Managers and decision makers are responsible for
ensuring that the results of those assessments are considered in the decision-making process.
All environmental decisions made by the Office of Water must be evaluated relative to the quality of
the underlying data and information and these evaluations must be documented. Where the quality of
the data or information cannot be controlled by the user (e.g., data from sources outside of the Office of
Water) or does not meet the objectives set during the planning phase, the decision will be adjusted
accordingly.
1.2 GRADED APPROACH
The graded approach to quality management may be the most important aspect of this plan and it will
apply to virtually all parts of the quality system. The basic philosophy behind the graded approach is to
recognize that "quality" is not an objective attribute that remains constant. Rather, quality is a subjective
attribute of a process or product that must be established in the context of the use of that process or
product. Environmental data are the products of many activities within the Office of Water.
Environmental decisions are also products, and they often are based on environmental data. Therefore,
the quality of the data and the effort to manage the quality of the data and the decisions should be based
on the end goal of the decision.
Not all decisions based on environmental data require the same numerical certainty in the underlying
results. Some decisions involve a greater risk if the decision is in error, for example, the risk to public
health if the level of a contaminant in drinking water is not adequately controlled.
Moreover, most environmental decisions made by the Office of Water are associated with some schedule
or deadline. These schedules and deadlines may be driven by legislative requirements, judicial decisions
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or consent decrees, funding priorities, or even emergency situations involving environmental accidents.
Thus, "good" quality data are those data that enable the user to make the decision at hand with an
acceptable risk of error and in the time frame required. Conversely, data that arrive too late to make the
decision may be of little or no value at all, regardless of any other measures of their quality.
This plan provides the Office of Water with an explicit mechanism to apply a graded approach to strike a
balance among the importance of the activity, the risk of a decision error, the schedule for completion,
and the available resources, when managing the quality of any activity involving environmental decision
making.
1.3 LIMITATIONS OF THE PLAN
This plan is a policy document and it cannot:
Be overly prescriptive, but will use examples and tools to provide context so that the user can tailor
the system to specific needs
Provide specific solutions, but will describe a general process and tools that can be used to support
quality management activities
Provide guidance for every situation or apply a single approach to all activities - it is a description of
the general approach needed to implement the Office of Water's quality policy
1.4 How THE PLAN AFFECTS You
This plan describes how you can manage the quality of your daily activities. While managers and other
staff may have specific roles in the quality system that are described in this plan, all staff in the Office of
Water play some role. If you are involved in the collection, evaluation, or use of environmental data, this
plan describes activities that are essential to meeting the Agency-wide requirements for quality.
Therefore, all Office of Water staff are required to:
1. Read the plan.
2. Identify your role in any data collection and environmental decision-making activities.
3. Identify the people in your organization with specific quality system roles, including managers and
quality system contacts, and your organizational relationships to them.
4. Discuss the plan and any questions you have with your supervisors and line managers.
5. Remain current on QA training requirements.
If you are an EPA contractor or a grantee, many aspects of this plan will flow down to your organization in
terms of specific contract or grant requirements to address quality. Therefore, you should follow the
same five steps listed above.
It is OW policy that all OW staff and managers participate in OW quality system training and adhere to
specific performance standards (PARS) related to implementation of OWs quality system and this Quality
Management Plan.
1.5 How THE PLAN is ORGANIZED
This plan addresses all ten of the required elements for an EPA quality system. However, in order to
promote the understanding and use of the document by the staff, it is written from the perspective of an
employee in the Office of Water, not a quality system specialist. Therefore, it is not rigidly organized
around those ten elements.
Chapter 1 is the introduction and includes the Office of Water quality policy statement.
Chapter 2 defines the types of environmental data and activities that are covered by this plan.
Chapter 3 identifies staff and management responsibilities for implementing this plan.
Chapter 4 provides an in-depth discussion of the tools and procedures used to implement the plan.
Chapter 5 describes the importance of documenting quality system activities.
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Chapter 6 describes the management of quality system documentation and records.
Chapter 7 describes our commitment to providing training that will allow for successful
implementation of this plan.
Chapter 8 describes the quality system requirements for computer hardware and software.
Chapter 9 addresses procurement and financial assistance.
The Reference section lists EPA quality system guidance and requirements documents.
The plan also includes a series of attachments that are checklists that may aid staff in the Office of Water
in carrying out the requirements of the quality system and documenting those activities. These checklists
include:
Generic Quality Assurance Project Plan Checklist
Three appendices from EPA's Contracts Management Manual Chapter 46 (Appendices 46.1 A,
46.1B, and 46.1C)
An example of the form used to define and approve the quality assurance requirements that will be
required for new contract acquisitions - this "Quality Assurance Review for Extramural Projects
(Contracts)" form is used to solicit new (or follow-on) contracts and is part of the Procurement
Initiation Notification (PIN) package
An example of a two page form used to define and approve the quality assurance requirements that
will be required for specific work assignments, task orders, and delivery orders - used after a contract
has been awarded and throughout the contract implementation
Cincinnati Procurement Operations Division Work Assignment Review Checklist
1.6 TERMINOLOGY
The OW Quality System applies to all environmental programs within OW and to any activity within those
programs that involves the collection or use of environmental data. Because activities are often
performed as part of a larger project, the use of the terms "activity" and "project" are used
interchangeably throughout this document.
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Chapter 2
Definition of Environmental Data
The focus of the quality system requirements in Order CIO 2105.0 is on environmental data. In the past,
this was often misunderstood to simply mean chemical measurement data collected in the field or in a
laboratory, and most quality system documents focused almost exclusively on procedures for assessing
the quality of such data. The latest Agency-wide order concerning quality makes it clear that the quality
system must address more than just measurement data.
Environmental data - Any measurements or information that describe environmental
processes, location, or conditions; ecological or health effects and consequences;
or the performance of environmental technology. For EPA, environmental data
include information collected directly from measurements, produced from models,
and compiled from other sources such as data bases or the literature.
Order CIO 2105.0, May 2000
The focus of this quality management plan is on environmental data, whether they are collected from
measurements, produced from or used in models, or compiled from other sources. Environmental
technologies are covered in the event that the Office of Water is involved.
TYPES OR SOURCES OF DATA
Many EPA organizations, including the Office of Water, distinguish between "primary" sources of data
and "secondary" sources of data, or "primary data" and "secondary data." For the purposes of this plan,
a primary source of data refers to data that are collected by the Office of Water, or under its direction
(e.g., by contractors, grantees, and others) for a specific purpose associated with the decision at hand..
The association of the data with the decision at hand is a critical distinction in the context of this quality
management plan. If the data are associated with a decision to be made by the Office of Water, then
those data are covered by this plan. Examples of primary data include, but are not limited to:
Field or laboratory data involving the physical, chemical, or biological characteristics of environmental
samples
Data on the physical location of such samples, including latitude, longitude, city, county, state
Field or laboratory data used to assess the performance of treatment systems or technologies
Financial information associated with the development of rules, regulations, or guidance documents
Engineering and process data
Results produced from models
When primary data are collected by the Office of Water, the collection activities must be planned with
quality in mind, and the quality of the primary data must be assessed against the needs of the project.
Chapter 4 of this quality management plan describes procedures for planning, implementing, evaluating,
and improving the quality of any activity, including the collection of primary data.
What often distinguishes primary sources of data from secondary sources is the control that the Office of
Water exerts on the generation of the data. This includes the ability to require that the information
needed to assess the quality of the data be generated along with the data and delivered to the Office of
Water. The control exerted by the Office of Water is often a function of the fact that the Office of Water is
paying for the data to be generated, but may also come into play where the Office of Water has direct
approval authority for the generation of data by an external party.
The Office of Water uses the term secondary data to describe the use of existing data that were not
directly generated by the Office of Water to support the decision at hand. Other terms such as "acquired
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data," and "data from other sources" have been used to express the same concept. Secondary data may
include:
Data collected by someone other than the Office of Water and not under the Office of Water's control
Data collected by the Office of Water or others for some other purpose than the current intended use
Data compiled from a variety of sources and published in the literature
Anecdotal information not collected in any organized fashion
This quality management plan is designed to encourage use of secondary data, where appropriate. The
secondary use of existing data can preserve budget resources by avoiding redundant data collection
activities within the Office of Water and across EPA programs. However, the challenge in using existing
data is that their generation is often outside of the Office of Water's control, and as a result, the Office
cannot directly manage or control the quality of the data. If the Office of Water lacks the ability to control
the quality of the data, then assessing the quality of the data becomes even more important. When the
Office of Water uses data that started as primary data generated by another program within the Office of
Water or another part of EPA, the quality of the data may be easy to determine by examining the
documentation that was produced with the data. In other cases, the data may have to be examined in
terms of who originally produced them and the quality may have to be inferred by less direct means.
Whatever the source, the quality of secondary data must be assessed. Chapter 4 describes planning
procedures for any data collection activity, including planning how secondary data may be assessed and
used in a manner that provides an acceptable level of risk in making environmental decisions.
The graded approach applies to the quality of environmental data as well. The decision makers and
planners must recognize that the quality of data must be defined by the use, and therefore, the decision
to be made. It is critical to plan for the use of data from either primary or secondary sources, but the
degree of planning and the quality of the data needed should be based on the importance of the project,
the risk of a decision error, the schedule for completion, and the available resources. Examples of the
subjective nature of quality and the use of a graded approach are provided below.
Americans face risks of illness from swimming and other recreational activities in coastal areas, lakes,
and rivers that are contaminated with disease-causing microbes. Many of the beaches and lakes are
monitored for conditions that present a threat to human health. When the conditions warrant, an advisory
may be issued or a beach may closed to swimming. The decision can be expressed as "Should an
advisory be issued or should a beach be closed?" The data used to make the decision may come from a
routine monitoring program. A series of water samples is collected over a 30-day period and analyzed for
enterococci, an indicator of sewage contamination. EPA established numerical guidelines for enterococci
in water that address the mean concentration of the organism in the samples as well as a statistical
protocol for evaluating the results. If the monitoring results exceed the guidelines, then an advisory may
be issued or the beach closed. The data require a high degree of quality management. A monitoring
program must be designed and implemented, samplers trained, a microbiological laboratory must be
hired, and statistical evaluations of the data must be made. This is a significant commitment of time and
effort to protect the potential users of the beach from possible exposure and infection.
In contrast, imagine that heavy rains entering a combined sewer system cause large lumps of untreated
sewage to wash onto the beach. The decision remains the same, "Should an advisory be issued, should
a beach be closed?" However, the untreated sewage is visually apparent and is sufficient evidence of a
problem without collecting samples or performing statistical analyses. The threat to human health is
immediate. Therefore, the visual observations of lifeguards with minimal scientific training provide data
that are of good quality for this decision. More importantly, the decision can be made on the schedule
required, i.e., immediately. Thus, using the graded approach, the decision to close the beach is made
without as much effort to manage the quality of the data.
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Chapter 3
Organization and Management of the Quality System
This chapter provides a brief overview of the Office of Water organizational structure and a detailed
description of the Office of Water's quality system, including responsibilities within that system. As an
Office of Water employee, you need to understand your responsibilities for implementing this plan. For
ease of reference, responsibilities are divided into two areas: program staff who are responsible for
managing and implementing projects within the Office of Water and quality system staff who are
responsible for assisting with and overseeing quality management activities. A third section focuses on
the unique set of roles and responsibilities required to manage quality in programs that are delegated to
Regions, States, Tribal, local, and other govern mental bodies.
3.1 ORGANIZATION OF THE OFFICE OF WATER
The mission of the Office of Water is to protect the nation's water resources. To accomplish this mission,
the Office of Water is divided into five major program offices. Each program office, other than the
American Indian Environmental Office, is divided into two or more divisions, and most of those divisions
are subdivided into two or more branches (see Exhibit 3-1). Because the branches are the origin of many
of the decisions that are based on environmental data, they also form the basis for the structure of the
Office of Water quality system. The immediate office and the five program offices are:
Office of Water Immediate Office
American Indian Environmental Office (AIEO)
Office of Ground Water and Drinking Water (OGWDW)
Office of Science and Technology (OST)
Office of Wastewater Management (OWM)
Office of Wetlands, Oceans, and Watersheds (OWOW)
3.2 APPLICABILITY ACROSS THE OFFICE
The quality system described in this QMP applies across the entire Office of Water. Although the Office
of Water involves a variety of different programs and different missions, all of the program offices and
divisions within OW use a common body of disciplines and tools (e.g., models, statistics, ecological
assessments, laboratory analyses, etc.) For example, both the Safe Drinking Water Act (SDWA) and the
Clean Water Act (CWA) allow stakeholders to request permission to use an alternate test procedure
(ATP) in lieu of the analytical methods that have been approved by EPA. Although the programs are
separate in that OGWDW is responsible for administration of the SDWA method approval program and
OST is responsible for administration of the CWA method approval program, both programs use the
same procedures and tools for implementing their programs. Accordingly, all OW programs are required
to adhere to the principles described in this QMP. Project- and mission-specific quality system
procedures are addressed at the Quality Assurance Project Plan (QAPP) level.
3.3 ORGANIZATION OF THE QUALITY SYSTEM
A fundamental principle of any quality system is that the system must receive direction from the top down
and be implemented from the bottom up. A quality system cannot be imposed on any organization from
above, nor overlaid on the organization without being incorporated into the organization's culture.
Accordingly, everyone in the Office of Water has some role to play in ensuring the quality of the products
of the Office of Water and everyone has a responsibility to do their best. However, there are a small
number of individuals with specific roles which must be fulfilled within the quality system itself.
The roles of these individuals are divided into two "tracks," one specifically for program staff, and the
other for those who specialize in managing the quality system itself, as shown in Exhibit 3-2.
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Note: If a Division has no branches, then the role of the Branch Chief may be filled by an Associate
Division Director. In addition, within some parts of the Office of Water, the Quality Assurance Coordinator
may be assigned at the Division level, rather than the Branch level. In these instances, the Quality
Assurance Coordinator will function at the Division level.
Contrary to common perception, the purpose of the two tracks is not to separate the responsibility for
quality from the routine management activities. Rather, the separate track for the quality system staff is
designed to ensure that the management of the quality system itself is independent of routine
management.
The staff within the quality system are responsible for the day-to-day functioning of the quality system and
for keeping management appraised on quality issues. In order to do that effectively, these positions
function independently of the line management structure. This is another fundamental tenet of any
quality system.
The solid lines indicate management authority within each track. The dotted lines indicate reporting
authority between the two tracks. As indicated, the staff in quality system team report information on the
status and success of the quality system to the management level above the one in which they function.
Finally, there are lines of communication between both tracks at every level. The communication lines
are shown with arrows at each end to emphasize the need for communications in both directions.
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Exhibit 3-1
Office of Water Organization Chart
Assistant
Administrator for
Watei
-. QA Manager
PnitctMwqtutnl
bnes of authority
Unesofcommunlcaton
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Exhibit 3-2
Management, Reporting, and Authority of OW Staff under the OW Quality System
National Program Manager/AA
Deputy AA for Water
Quality Assurance
Manager
Quality Assurance
Officer
Quality Assurance
Coordinator
\
\
Management Authority \
Reporting Authority
Communication
Office Director
Division Director
Branch Chief
Technical Staff
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3.4 PROGRAM MANAGEMENT AND STAFF RESPONSIBILITIES
3.4.1 Role of Management
Every member of the management structure within the Office of Water is responsible for implementing
the quality system. There are costs associated with producing quality work and for managing quality.
However, those costs are generally far less than the cost of redoing the work to achieve a quality product
or to defend against a poorly-made decision. Managers are responsible for allocating resources (budget
and staff) to every project undertaken within their part of the Office, and those resources must be
sufficient to carry out the technical work and ensure its quality. Managers set schedules and establish
priorities, both of which must reflect the demands of quality management. One of the most important
quality system functions the managers perform is communication, both up and down the management
chain. It is the managers who can communicate the importance of quality within the organization and
who can most readily affect its incorporation into the organization's culture. While communications may
focus on specific quality problems, managers must also communicate the need for quality training (see
Chapter?), staff and budget resources, and systematic planning.
The quality system responsibilities of the four levels of management from the Assistant Administrator
(AA) for Water to the Branch Chiefs are summarized in Exhibit 3-3 and are based on the requirements
described in Order CIO 2105.0. These managers maintain frequent communication and work in concert
with the quality system staff within the Office of Water to manage the quality system and incorporate it
into all environmental decision-making activities within the Office that rely on environmental data. The
quality system functions from the bottom up, such that the responsibility at each level of management
builds on the efforts of the levels below.
Exhibit 3-3
Quality System Responsibilities of Office of Water Managers
Management Responsibility
Compliance with the quality system by EPA staff
Communicating the importance of quality to staff
Providing adequate resources for the quality system, including training, travel, staff
and budgets
Ensuring that decisions are supported by data of known quality
Compliance with the quality system by delegated programs
Compliance with the quality system of extramural organizations
Ensuring that performance agreements contain quality system standards
Quality system training is provided to staff
Systematic planning of all projects within the organization
Assessment of data quality
Determining the need for quality system training
Participation in systematic planning
Approval of project planning documents
Approval of the Office of Water quality management plan
AA/ Deputy
AA
0
o
o
Office
Director
O
0
0
0
Division
Director
0
0
Branch
Chief*
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Exhibit 3-3
Quality System Responsibilities of Office of Water Managers
Management Responsibility
Periodic evaluations are conducted of internal and external organizations
Documenting quality management activities within the organization
Sampling, analysis, and data handling procedures meet quality system
requirements and are documented, reviewed, and approved
Identifying need for project SOPs
Identifying need for organizational SOPs
Ensuring implementation of corrective actions within the organization
Compliance with Information Quality Guidelines
Remaining current on QA training requirements
AA/ Deputy
AA
0
0
o
Office
Director
O
0
Division
Director
O
o
Branch
Chief*
* In a Division with no Branches, this is Associate Division Director
= Primary management responsibility
O = Oversight responsibility
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3.4.2 Roles of Project Leads, Contract and Grant Project Officers, Delivery Order Project
Officers, and Project, Task Order, and Work Assignment Managers
A contracting officer representative (COR) is the authorized representative of a contracting officer (CO).
A COR may be either an EPA employee or another Federal Agency, nominated by the program office
and appointed by the CO, who possesses the necessary knowledge, skills, and abilities to perform the
COR duties. COR duties are listed in the COR Workbook, which is available on the Federal Acquisition
Institute website (http://www.fai.gov/pdfs/corbluebook.pdf). These duties, along with EPA-specific
information are also listed in the EPA Contracts Management Manual (CMM), appendices 42.1 A and
42.1B. Over the years, EPA has developed a wide range of Agency titles for employees who perform
COR duties, such as project officer (PO), work assignment manager (WAM), delivery order project officer
(DOPO), task order project officer (TOPO), task manager, etc. Regardless of the title or their varying
roles, all these individuals are CORs. The basic differences center on the acquisition instrument the COR
manages, whether it is a basic contract, work assignment, task order, or delivery order. Regardless of
the title, all CORs play important roles in implementing the quality system, particularly in regard to the
activities of contractors and grantees. If you manage activities under a contract or grant, refer to Exhibit
3-4 to identify specific responsibilities that you have for implementing the quality system within that
vehicle.
Exhibit 3-4
Quality System Responsibilities of Project Leads, Contract and Grant Project Officers,
and Other Contract Officer Representatives
Participating with senior program staff and technical personnel in systematic planning for the project, including the
development of project objectives, the associated measures of quality, and acceptance criteria (see Chapter 4)
Identifying the resources needed for the project, including quality system training needs, and requesting funding
from the Branch Chief to meet those needs (see Chapter 4)
Coordinating with the Quality Assurance Officer in the selection and design of reviews, assessments, or other
performance evaluations appropriate for the project (see Chapter 4)
Identifying and implementing project-specific quality management procedures, which may include data quality
assessment, information management, data integration, and data validation (see Chapter 4)
Completing the appropriate Quality Assurance Review Forms for any extramural projects involving environmental
measurements to indicate the quality system requirements that must be included in the development of a contract
task order or work assignment, PIN package, or a Request for Proposal (see Attachments C and D)
Ensuring that work assignments, work plans, and contract deliverables include quality system documentation
appropriate for the activity (see Attachments D and E)
Preparing and implementing quality system documentation appropriate for the project (see Chapter 5)
Complying with quality system standards in performance agreements
Complying with Information Quality Guidelines, including preparation of IQG Pre-Dissemination Review Checklists
(see Chapter 5)
Remaining current on QA training requirements
3.4.3 Role of Technical Staff
As noted earlier, quality systems are implemented from the bottom up, and all Office of Water staff play a
role in the quality system. All technical staff members involved in the generation or use of environmental
data are responsible for complying with this plan. This includes:
Reviewing and understanding the quality requirements that are specific to your project(s)
Implementing and documenting your quality management activities (see Chapters 4 and 5 and the
attachments to this plan)
Reporting any quality management concerns to your supervisor or Quality Assurance Coordinator
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Complying with Information Quality Guidelines, including preparation of IQG Pre-Dissemination
Reviewing Checklists where relevant (see Chapter 5)
Remaining current on QA training requirements
3.5 QUALITY SYSTEM MANAGEMENT AND STAFF RESPONSIBILITIES
A hierarchy of quality system staff oversees the implementation of the Office of Water quality system. As
shown in Exhibits and 3-1 and 3-2, four specific titles are assigned to staff managing the quality system:
National Program Manager for the Office of Water, Office of Water AA/Deputy AA
Quality Assurance Manager (QAM), designated by the Office of Water
Quality Assurance Officers (QAO), designated by each Program Office Director and by the Deputy
AA for the Immediate Office
Quality Assurance Coordinators (QAC), typically assigned to each Branch/Division within the Office of
Water, designated by Division Directors and Branch Chiefs
Note: Within some parts of the Office of Water, the Quality Assurance Coordinator may be assigned
at the Division level, rather than the Branch level. In these instances, the Quality Assurance
Coordinator will function at the Division level.
As noted earlier, the roles of these staff are to make sure that the quality system functions on a day-to-
day basis (Exhibit 3-2). In order to do that effectively, these positions function independently of the line
management structure. This is another fundamental tenet of any quality system.
Ideally, each of these quality system positions would be staffed by individuals who are able to dedicate
100% of their time to their quality system roles. In reality, the Office of Water must balance the resource
constraints of budgets and staff levels against a variety of other factors including legislative mandates
and judicial schedules. As a result, most of the staff fulfilling these quality system roles do so only part
time, and also fill technical roles within each of their organizations. When performing work within the
quality system, they report to management as described in this plan. When performing technical work,
they report to the level of management appropriate for the technical work. Therefore, these individuals
must ensure that they are not performing reviews associated with the quality system of work to which
they made substantive technical contributions. The structure described here provides a sufficient number
of Quality Assurance Coordinators to allow them to cross between Branches when needed to avoid such
conflicts. Likewise, the Quality Assurance Officers and the Quality Assurance Manager can share and/or
delegate responsibilities for certain projects in which one or the other has played a technical role.
3.5.1 National Program Manager
The National Program Manager is responsible for the design, implementation, operation and performance
of the Office of Water (OW) quality system. The NPM works principally through the Quality Assurance
Manager (QAM) located in the OW Immediate Office (IO) on all matters of quality.
3.5.2 Quality Assurance Manager
The Quality Assurance Manager serves as the focal point for implementation of the quality system and is
responsible for Office of Water quality management efforts through a network of Quality Assurance
Officers and Quality Assurance Coordinators located in the program offices. The Quality Assurance
Manager reports to the National Program Manager for Water on all quality matters, and assists line
management in interpreting EPA quality policy and in developing quality policy and procedures for the
Office of Water. The Quality Assurance Manager is responsible for all quality management activities
including the following:
Inform the National Program Manager on quality assurance issues
Define and document the Office of Water quality management plan
Develop office-wide quality policies and procedures
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Review and approve Office of Water standard operating procedures (SOPs) as described in Section
5.8 of this QMP
Compile the Quality Assurance Annual Report and Work Plan and monitor progress against the work
plan
Perform assessments and reviews, and overseeing the implementation of internal and external
quality management evaluations - includes coordination of all QA Reviews within OWand Regional
Offices that support OW programs and directing OW Quality System Assessments as described in
the Office of Water Guidelines for Internal Assessment of OW Quality System Documentation,
available on the Office of Water intranet
Strive to align OW quality system requirements with Regional offices, States, Tribal, local, and other
governmental bodies
Serve as the liaison between Office of Water and the Quality Assurance Managers in other programs.
This function includes participation in QA conference calls and the Annual National QA Meeting
sponsored by the Office of Environmental Information
Coordinate Agency-wide and interagency quality functions
Comply with Information Quality Guidelines
Remain current on QA training requirements
Identify quality training needs, coordinate available resources for QA training for OW staff and
managers, and ensure that required training is implemented
Ensure that Performance Partnership Agreements (PPAs) and Performance Partnership Grants
(PPGs, or "block grants") address OW quality system requirements in concurrence with Regional
approval of the PPAs and PPGs
The Quality Assurance Manager has the authority to carry out these responsibilities and to bring to the
attention of the Assistant Administrator any issues associated with these responsibilities.
3.5.3 Quality Assurance Officer
A Quality Assurance Officer is assigned to serve in the immediate office and in each program office. The
Quality Assurance Officer's primary responsibilities are to oversee all aspects of quality system activities
within their program office or the immediate office. The program office Quality Assurance Officers report
directly to their Office Director and the Quality Assurance Manager regarding QA matters. The immediate
office Quality Assurance Officer reports directly to the Deputy AA and the Quality Assurance Manager
regarding QA matters.
Specific activities include:
Participate in regularly scheduled Office of Water quality system team meetings and review and
contribute to quality system documentation developed and published by the quality system team
Define and develop approaches needed to manage quality (e.g., manual or automated systems to
identify or track the planning, review, and implementation of data collection projects, review of results,
or documentation of project activities)
Establish and maintain a list and description of business processes executed within the program
office
Assist program office staff and project managers in identifying needs for and developing quality
policies and documents and in obtaining answers to technical quality questions
Review and approve program office SOPs as described in Section 5.8 of this QMP
Assist the Quality Assurance Manager in interpreting EPA quality policy, and report the status of
program office conformance with quality objectives to the Quality Assurance Manager
Develop assessment materials and performing reviews and assessments. Participate in Office of
Water Quality System Assessments as described in the Office of Water Guidelines for Internal
Assessment of OW Quality System Documentation
Provide input to the quality management plan
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Compile the program office Quality Assurance Annual Report and Work Plan, contribute to the Office
of Water's Quality Assurance Annual Report and Work Plan, and monitor progress against the work
plan
Participate in the Annual National QA Meeting sponsored by the Office of Environmental Information
Comply with Information Quality Guidelines, and retain the completed, approved Pre-Dissemination
Review Checklists
Remain current on QA training requirements
Ensure that all personnel in the program office have received appropriate QA training and are current
in their training
The Quality Assurance Officer works closely with management to ensure that:
Quality system requirements are integrated into Federal regulations and into the programs operated
by Regions, as well as State, Tribal, local, and other governmental bodies and the regulated
community, to ensure that data of known and documented quality are generated by program offices
and their delegated programs
Assessments/reviews are conducted with sufficient depth and frequency to ensure adherence to
approved plans, and to identify deficiencies in the quality system
Appropriate corrective actions are implemented in a timely manner in response to assessment/review
findings
All Office of Water personnel, contractors, and grantees who are involved in the collection and use of
environmental data have access to needed quality system training or information
Appropriate quality system requirements are included in all contract solicitations, assistance
agreements, and interagency agreements which entail data collection, and that those requirements
are met
3.5.4 Quality Assurance Coordinator
The Quality Assurance Coordinator's major responsibility is to assist the Quality Assurance Officer in the
implementation of the quality system. The responsibilities of the Quality Assurance Coordinator are to
oversee the day-to-day quality management activities within the Branch (or Division), implement quality
system policies under the direction of the Quality Assurance Officer and the Quality Assurance Manager,
and serve as the contact person for the technical staff. The Quality Assurance Coordinator reports
directly to the Division Director and the Quality Assurance Officer regarding quality management matters.
Specific activities include:
Report to management on the status and requirements of the Branch's (or Division's) quality system
activities and act as a conduit for quality management information to Division and Office staff
Serve as the central point for coordinating all Branch (or Division) quality management activities,
including assessing, reviewing, and resolving quality issues
Participate in Office of Water Quality System Assessments as described in the Office of Water
Guidelines for Internal Assessment ofOW Quality System Documentation
Review and approve all internal, contractor, and grantee quality system documentation as well as the
quality sections of all regulations, program guidance, procurement guidance and grants
Provide guidelines for content and format of quality system documentation, including standard
operating procedures, quality assurance project plans, and other planning documents
Review and approve division level SOPs as described in Section 5.8 of this QMP
Track the preparation, review, and approval of quality system documentation
Prepare requested sections of the Office of Water's Quality Assurance Annual Report and Work Plan
and review the quality section of Branch and Division reports
Comply with Information Quality Guidelines
Remain current on QA training requirements
Ensure that all personnel in the Branch (or Division) have received appropriate QA training and are
current in their training
The Quality Assurance Coordinator works closely with line management to ensure that:
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Appropriate planning and quality system documentation are prepared for all activities involving the
collection or use of environmental data and are approved in writing by management and quality
system staff at the appropriate levels
Quality system procedures conform to Agency quality system guidance and requirements
Routinely used procedures that affect data quality are described in standard operating procedures or
other appropriate documentation
3.6 DELEGATED PROGRAMS - RESPONSIBILITIES OUTSIDE OF THE EPA HEADQUARTERS
STRUCTURE
Many programs within the Office of Water are delegated to EPA Regions and to States, Tribes, and local
governments. Specific quality management responsibilities that reflect the limited role of the Office of
Water staff involvement in these activities are defined below. Chapter 9 of this plan also addresses
aspects of delegated programs, in the context of using financial assistance (grants and assistance
agreements) and project partnership agreements to implement appropriate quality management in such
programs.
3.6.1 Activities Delegated to EPA Regions
Office of Water quality staff work collaboratively with EPA Regions. The relationship between the Office
of Water and the EPA Regional offices varies on a program-by-program basis. The Office of Water is
responsible for overall policy, guidance, and regulation development. Management of day-to-day
activities of Regional water programs is the responsibility of the Directors within each Regional office.
Regional quality staff work collaboratively in developing and overseeing implementation of the Regional
quality systems. For programs that are directly implemented by the Region, the Regional quality system
takes precedence over the Office of Water quality system in areas where Regional policies and/or
procedures are more comprehensive or stringent, although the OW quality assurance manager is
responsible for ensuring that the OWs quality system requirements are met.
For Office of Water programs delegated to the EPA Regions, oversight and coordination of day-to-day
quality management activities are performed by the Regional quality staff. Notifying the Region of
projects that require Regional oversight is accomplished through the financial-assistance and contractual
processes described in Chapter 9 of this plan. The responsibilities of the Regional quality staff may
include reviewing and approving quality system documentation, planning and performing assessments
and reviews, reporting assessment findings, and training Regional, State, Tribal, local, and other
government personnel.
The Office of Water Quality Assurance Officers provide guidance and support to the Regional quality staff
in monitoring specific Office of Water programs that have been delegated to Regional offices when
requested and/or as needed. These activities may include training, interpreting Office of Water quality
system policies, developing guidance documents, and reviewing and approving quality system
documentation when requested.
3.6.2 Delegated States, Tribal, Local, and Other Governmental Bodies
In cases where Office of Water programs are delegated to States, Tribal, local or other government
bodies, the delegated organization is responsible for implementation of a quality system that complies
with EPA quality system policies and guidance.
3.6.3 Oversight of Delegated Programs
Oversight of delegated programs is applied uniformly across all OW program offices, with the exception
of AIEO, which has unique oversight requirements that are being addressed separately by the OWQAM.
In accordance with EPA policies, when authority is delegated to an organization other than EPA, that
organization is responsible and fully accountable for any actions it takes in exercising that authority. The
Office of Water ensures that delegated programs are implemented according to EPA policy and guidance
through the use of a differential oversight policy established in a Performance Partnership Agreement
(PPA) or Performance Partnership Grant (PPG, also known as a "block grant"). These grants are
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typically negotiated between the State, Tribal, local, or other government body and the applicable EPA
Region. In most such cases, the applicable Region has direct oversight responsibility for technical
implementation of the PPA or PPG. If OW provides funding for the PPA or PPG, then OW retains
oversight responsibility for ensuring that OW's quality system requirements are met within the framework
of federal regulations defined for grantees. These regulations specify that if the proposed PPA or PPG
project involves environmentally related measurements or data generation, the recipient must develop
and implement QA practices. These practices must be sufficient to produce quality data to adequately
meet project objectives and to minimize data loss due to uncontrolled conditions or malfunctions. (State,
local or Indian tribal government recipients are subject to regulations at 40 CFR 31.45; all other recipients
are subject to 40 CFR 40 CFR 30.54.) OWs oversight of these practices may be accomplished in a
variety of ways, depending on the scope and needs of each delegated program. Examples include, but
are not limited to:
Reviewing Regional QMPs to ensure they include requirements that States, Tribes, other local, and
other government bodies have QMPs or equivalent quality systems in place for all delegated
programs
Using OWs annual grant guidance documents as a mean to clearly delineate to the Regions the
Office of Water's QA expectations for critical data and information requirements
Providing clear, step-by-step guidance on all quality requirements for implementation of delegated
programs
Periodically assessing Regional implementation of delegated programs
Verifying and validating satisfactory implementation of OWs quality system requirements through
examination of work products from the delegated program
Requiring the Region to certify that it is implementing its quality system, and that this Regional quality
system meets OWs QMP requirements; such certification may be provided by the applicable quality
staff member in the Region or by the business manager responsible for the program in the Region
(e.g., the Division Director)
Other techniques for measuring the performance of the delegated program include obtaining feedback
from stakeholders, and communications between Office of Water staff and the other organization. These
communications vary with the nature of the delegated program, program maturity, and available
resources, and may include site visits, meetings, and conference calls.
3.7 ASSESSING THE OW QUALITY SYSTEM
All Office of Water staff are responsible for fulfilling their quality system responsibilities as described
above. Each year, the Office of Water conducts internal assessments to review implementation of the
quality system requirements described in this QMP and to identify areas where additional attention would
bring significant benefits. The Office of Water selects one of its five programs for internal assessments
each year, so that each program office is reviewed at least once during a five year cycle. This Office of
Water self-assessment is led by the Quality Assurance Manager, or designee (usually a QAO from one of
the offices not being internally assessed that year), and performed by an Assessment Team that includes
staff who are knowledgeable in the technical activities being reviewed and effective QA practices and
policies.
In addition to these internal self-assessments, the Office of Environmental (OEI) Information Quality Staff
performs periodic external assessments of the Office of Water quality system. These external OEI
assessments are performed every three years.
Refer to Section 4.3.4.8 for additional information regarding these assessments of the Office of Water
quality system.
3.8 DISPUTE RESOLUTION
An important aspect of the Office of Water quality system is frequent and open communication among
and between the parties with management responsibilities and quality system responsibilities. One goal
of those communications is to avoid disputes. However, when issues regarding quality system activities
are in dispute, resolution should be sought at the lowest management level practicable. To ensure
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independence, quality system staff from the next higher level within the organization will assist
management in the resolution (e.g., if the issue is to be resolved by a Branch Chief, then the Quality
Assurance Officer above that Branch should be involved). Should agreement not be reached at this
level, the issue will be resolved by the Office of Water Quality Assurance Manager, (Office and Division
directors), in coordination with OW senior managers. The Office of Water National Program Manager is
the final authority to resolve disputes involving Office of Water quality system issues.
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Chapter 4
Planning, Implementing, Evaluating, and Improving Quality
The concept of the "quality cycle" was made popular by W. E. Deming in the 1980s. The Office of Water
has translated Deming's four components of: plan, do, check, and act, into:
Planning projects with quality in mind
Implementing the project according to plan and making revisions when needed to address
unforeseen problems or changes
Evaluating the quality of interim and final products against the planned goals
Incorporating lessons learned into future activities
Office of Water processes for addressing each of these components is addressed in Sections 4.1 through
4.4 of this chapter. Documentation is not considered a distinct phase in the Office of Water quality
system. It is an ongoing requirement that you must perform throughout all phases of your project.
Indeed, it is often argued that if you did not document your quality management activities, you did not
perform them. Because documentation is so important, this plan includes a stand-alone chapter to guide
Office of Water managers and staff in documenting their quality management activities (see Chapter 5).
4.1 PLANNING QUALITY IN OFFICE OF WATER ACTIVITIES
Just as the three most important principles in real estate are location, location, location, the three most
important principles in quality management are planning, planning, planning! Because quality must be
built into a project at the start, not added later, a crucial requirement of the Office of Water's quality
system is the use of up-front, systematic planning for all projects, particularly those that will rely on
environmental data of one form or another. Although such projects vary greatly in scope and importance,
each should be started in essentially the same way - by determining the relevance of the activity and the
level of quality required, and by planning accordingly.
4.1.1 Planning Process
The planning steps outlined here are not absolutes, but are a suggested approach to planning that will
enable you to plan effectively and meet the requirements of the Office of Water quality system. Other
steps can be taken, other questions asked. The Office of Water's Program Management Office has
recently developed several templates to aid project managers in project planning. Although these
templates were initially aimed at supporting information technology (IT) projects, they have been
successfully adapted to non-IT projects by excluding the IT-specific sections. Use of these templates has
been helpful to project managers in reaching consensus on project scope and objectives and identifying
and addressing project quality needs. Other project managers have found it useful to use the Quality
Assurance Project Plan elements listed in EPA QA/R-5, EPA Requirements for Quality Assurance
Project Plans (see reference section) as an effective tool for identifying project scope, objectives, quality
needs and strategies to meet those needs. Other approaches also may be followed. The point is that
systematic planning is essential to managing quality and must be carried out by a group with sufficient
knowledge to ensure that the relevance of the project and activities undertaken will result in a product that
will have the level of quality needed for its intended purpose.
Step 1 - Identify the Project Scope and Purpose
The planning process should begin by addressing the following basic questions:
What is the primary goal and purpose of the project?
How is the activity (or project) relevant to our organization's mission, and why is it important to
proceed?
Who is the "customer" for this activity (e.g., senior EPA management, the public, Congress, the
regulated community, etc.)?
What are the customer's requirements?
Are environmental data required? If so, who are the "suppliers" of those data?
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Are there discrete tasks within the project scope?
What are quality requirements for the tasks within the project?
What are the quality requirements for the activity?
What is the schedule for completion and is it driven by forces outside of the Office of Water (e.g.,
legislative or judicial deadlines)?
While the questions need not be in this exact format, 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 work out the details.
The project manager should assemble a team that includes members of the management team, staff with
a firm technical grasp of the subject matter, be it environmental chemistry, economics, or statistics, to
name just a few, as well as those persons who control the budget and those who manage any contractors
or grantees involved in the effort. It is also essential that the team or work group consult with or seek
direction from a member with an assigned quality system role at an appropriate level within the
organization, such as the Quality Assurance Coordinator for an activity in a branch, or a Quality
Assurance Officer for an activity at the Program Office level. If a team approach is not employed, it is
even more important that a person within the quality system be consulted in the initial planning phase of
the activity to ensure that quality system requirements are being addressed.
Step 2 - Identify Resource Requirements
The answers to the questions above outline the requirements for the activity, which must include the
requirements for quality. Once the basic requirements are established, you have to answer additional
questions that will drive the implementation phase of the project. These questions include:
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 kinds 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?
If you do not have suitable answers to these questions, then you may need to modify the design or scope
of the activity to ensure that the product will meet the quality requirements on schedule and with the
available resources.
Step 3 - Identify Performance Measures
The third step is to identify how you will recognize if you have been successful. As in:
How can we measure the success of the project (e.g., through quantitative measures, surveys, peer
review, etc.)?
The measure of success is an important aspect of the assessment and corrective action phases of the
project, which are discussed at the end of this chapter.
4.1.2 Planning Tools
The Office of Water approves the use of a variety of planning tools that can help you manage the quality
of your activities. These tools include quality and peer reviews, the use of simple software tools that may
be used to identify project milestones and resources, and a formal multi-step process used to derive
qualitative and quantitative statements concerning data quality objectives for the project. Possible
planning tools are described below. This list is not exhaustive, and Office of Water staff are free to use
any other tools that may facilitate their planning processes. The selection of appropriate planning tools
should be done on a case-by-case basis using the graded approach described in this quality
management plan. In accordance with the Office of Water's bottom-up philosophy concerning
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implementation of the quality system, the selection of appropriate planning tools should be made at the
lowest possible level (i.e., the project or Branch level).
Quality Review: Also known as peer input or peer consultation, this type of planning review refers to the
involvement of technically qualified peers during the development of an Agency work product and
includes an open exchange of data, insights, and ideas. Depending on the project size and scope, it may
be advisable to ensure that stakeholder concerns are represented in this review. Peer consultation also
is an effective tool during the assessment stage of the project and, therefore, is further described in
Section 4.3.4.1, under the assessment tool section of this QMP.
Note: In accordance with EPA's Peer Review Policy, as revised January 2006, peers or stakeholders
who provide active, ongoing input and participation in the development of a work product are not eligible
to undertake a formal peer review of that work product because they lack independence from its
development.
Checklists: Certain projects may be small enough, routine enough, or straightforward enough that quality
can be adequately planned through the use of standardized checklists developed at the Office, Division,
Branch, or even Project level. For example, the Office of Water has developed the Office of Water
Project Quality System Documentation Checklist that may be used to document project planning
activities. This optional checklist is available on OWs intranet. The Office of Water encourages each
program office to consider the development and use of checklists to facilitate efficient planning and
documentation of such projects.
Project Scheduling Software: Commercially-available software tools are designed to identify project
milestones including interim deadlines, identify resources needed to complete the project, and identify
scheduling conflicts. These tools typically allow projects to be either forward-scheduled (i.e., planned
forward from a specific project start date) or reverse-scheduled (i.e., planned backwards from the
scheduled project due date).
Data Quality Objective Process: A formal, multi-step process described in EPA QA/G-4, Guidance for the
Data Quality Objective Process (see the Reference section of this QMP) was developed as a systematic
planning tool for environmental data collection. The process was originally developed around primary
data collection activities and while it may be applicable to establishing objectives for secondary uses of
data, it retains a focus on primary data collection. Therefore, although it is not required, the Office of
Water highly recommends that it be employed where practical.
Formal Peer Review: EPA has a formal Peer Review Policy, described in the EPA Peer Review
Handbook (3rd edition, EPA/1 OO/B-06/002). In accordance with this policy, the Office of Water requires
that Peer Review be incorporated into the planning process for all scientific or technical work products
that may be considered to be influential scientific information, including highly influential scientific
assessments. This documented, critical review is an in-depth assessment of the assumptions,
calculations, extrapolations, alternate interpretations, methodology, acceptance criteria and conclusions
pertaining to the scientific or technical work product and of the documentation that supports this product.
The determination that a scientific or technical product is "influential scientific information (ISI)" 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?
Is it likely to have an annual effect on the economy of $1OOM or more, or adversely affect in a
material way the economy, a sector of the economy, productivity, competition, jobs, the environment,
public health or safety, or State, Tribal, or Local governments or communities?
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If your project meets one or more of the above criteria, a formal Peer Review is required unless it meets
the criteria for the exemption, receives a waiver, or is otherwise determined not to be warranted as per
the Peer Review Handbook. Consult the Peer Review Handbook to identify appropriate planning
measures that need to be taken to ensure that project schedules and resources are adequate to allow for
this review.
If a scientific and/or technical work product has been categorized as ISI, it is also a candidate for
consideration as a highly influential scientific assessment (HISA). As with ISI determinations, the HISA
determination is made on a case-by-case basis, and is largely based on the same factors as identified
above. The primary differences between a product that is ISI only and one that also is a HISA concerns
their degree of influence and substance. If it can have a potential impact of more than $500M in any year
it is considered a HISA. Likewise, the more far-reaching or significant the impacts of a scientific
assessment are, the more appropriate it is to categorize it as a HISA.
Whatever planning tools are employed, they must be used in a systematic fashion. A graded approach to
planning ensures that the level of detail addressed in the planning phase is commensurate with the
importance of the work, its intended use, the available resources, and the schedule.
EPA maintains a database, called the Science Inventory (http://cfpub.epa.gov/si'), which is designed to
track and report peer review and other science activities. EPA uses this database to make its peer
review plans for ISI and HISAs available for public comment, as required by EPA's Information Quality
Guidelines (discussed in Chapter 5). OW has designated individuals within the various Offices who are
responsible for keeping the Science Inventory up to date. Two standard forms (available on the Office of
Water intranet) are used to report activities and products for inclusion in the Science Inventory: the "Data
Entry Form for Science Activities" and the "Data Entry Form for Products". If your project includes a
product or activity that meets the criteria above or is otherwise a candidate for peer review, you must
document it on the appropriate form and submit it to the designated point of contact for your Office.
4.2 IMPLEMENTING QUALITY MANAGEMENT ACTIVITIES
As described in Chapter 3, all Office of Water staff and managers are responsible for implementing this
quality management plan. The Assistant and Deputy Assistant Administrator for Water, Office Directors,
Division Directors, and Branch Chiefs do so by committing the staff, training, and other resources
necessary to successfully implement the quality system.3 The Office of Water quality system is
comprised of the National Program Manager, Quality Assurance Manager, Quality Assurance Officers,
and Quality Assurance Coordinators, who are charged with implementing this Quality Management Plan
by:
Assisting project managers and staff with incorporating quality management into their daily activities
Monitoring program activities to ensure that the quality system is being implemented as planned
Reporting the status of quality management activities to senior management and EPA Quality Staff
At a minimum, implementation of quality management activities at the project level requires that an
approved QA Project Plan (or equivalent documentation as described in Chapter 5) is kept current
throughout the project or task, and that the QAPP is implemented as prescribed. If the QAPP is written
by a contractor in support of a multi-year project or activity that crosses contractual performance periods,
the existing QAPP can suffice unless conditions change or new work elements are added in the new
contract period requirements. In such cases, it is recommended that the EPA contracting officer
representative (COR) re-issue the existing QAPP as part of the new work assignment, task order, etc,
with a requirement for only minor and necessary updates. Additional strategies for implementation of
quality management activities at the project level depend on the specific activities involved in the project.
As a result, it is not practical to suggest a "cookbook" approach that will cover all projects. However, the
staff participating in a project can start to implement the quality system by meeting the following generic
requirements:
3 The Assistant Administrator for Water has delegated this responsibility to the Deputy Assistant
Administrator for Water.
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Make sure you are aware of and familiar with any approved quality assurance project plans or other
documents governing the quality system to be used on the project. Project managers must provide
this information to the technical staff. If the staff have not received such materials, they need to ask
the project manager if they exist.
Identify your specific responsibilities listed within these materials. If such materials do not exist,
identify specific steps you can take to ensure the quality of work you produce.
Consult with the project manager and/or technical peers about changes in project scope or
unanticipated problems that may not be adequately addressed by the existing quality system.
Document problems that may be encountered on your project, including any deviations from the
Quality Assurance Project Plan (QAPP) or other quality system documentation, and the steps taken
to resolve those problems. (Documentation requirements are described in greater detail in Chapter
5).
4.3 EVALUATING THE RESULTS AND MAKING ADJUSTMENTS
The planning and implementation aspects of quality management are not performed simply to satisfy the
requirements of the EPA quality order. Rather, they are the first steps in the quality management
process. It is not possible to manage quality or learn from past mistakes without evaluating the results of
a project in relation to the plan and taking any corrective actions that may be needed. Closing the quality
cycle requires evaluating the success of the project and considering how the process can be improved.
4.3.1 Planning Assessments
There is a wide range of tools and processes available to evaluate the quality of project activities and
their resulting work products. The Office of Water encourages the use of any processes or tools that
promote cost-effective quality assessments and recommends that these tools be selected at the project
level. Selection of assessment tools to be used for each OW project is made during the project planning
phase and is documented in the QAPP, along with criteria that will be used to perform the assessment,
the timing and frequency of the assessments, the personnel that will perform the assessments and any
special qualifications required of those personnel, The Project Manager is responsible for ensuring that
each of these elements is defined and documented in the QAPP and for ensuring that the assessment
activities are implemented as described in the QAPP.
The ultimate goal of any given evaluation is to determine which aspects of the quality system are working
properly and which are not. However, the common perception of any of these evaluations is that they are
designed simply to find problems. That perception can lead to an "us versus them" mentality that pits the
evaluators against the staff performing the work and defeats much of the purpose of the quality system.
Everyone in the Office of Water has a responsibility to make the quality system work effectively. For this
reason, assessments must be performed by individuals who are knowledgeable and experienced in the
type of work they are assessing. Such a background will enable the assessor to avoid simply "checking
off a box" without being able to ask follow up questions that may be necessary to properly evaluate
deviations in complex situations. A qualified assessor should not only be able to identify deviations from
the expected criteria, but also be able to understand whether and how those deviations will adversely
impact overall project quality, and help identify solutions that can be implemented to address problems.
Each Project Manager is responsible for ensuring that qualified individuals are selected to assess
activities or products developed in support of his/her project. In addition, the Project Manager must
ensure that personnel who perform the assessments have no real or perceived conflict of interest, and
have no direct involvement in or responsibility for the work being assessed.
4.3.2 Conducting and Documenting Assessments
Individuals who perform assessments are responsible for clearly documenting their findings. If problems
are identified, the assessor documents the problems, along with the impact of these problems on the
quality of the work produced and on the overall project the work is supporting. The assessor also
recommends corrective action to address the deficiencies. To the maximum extent practical, the
assessor works with the assessed organization to discuss the situation and identify clarifications and
additional information that might address the deficiencies or prevent more severe problems as the project
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progresses. For example, before concluding that laboratory data are invalid because there is no
evidence that the instrument was calibrated before analyses were performed, the assessor should make
an effort to contact (or for contractors and grantees, have the COR contact) the laboratory to determine if
calibration was performed and calibration data are available for assessment.
4.3.3 Corrective Actions
Upon completion of their evaluation, the assessor provides his/her findings to the Project Manager, who
is responsible for ensuring that the problems are addressed. If the problems are adversely affecting the
overall quality of the work product and can be corrected within the project schedule, budget, and
resources, the Project Manager takes the steps necessary to correct the problems. If the work was
performed by a contractor or grantee, the Project Manager works with the Contracting Office
Representative (COR) to ensure that corrective actions are implemented under the terms of the contract
or grant. If the problems cannot be corrected, the Project Manager is responsible for ensuring that all
known limitations of the data generated to support the work product are known to all potential data users
and decision makers.
4.3.4 Assessment Tools
Several of the evaluation tools are the same as those used to plan quality management activities (section
4.1.2). For example, peer consultation and peer review are effective ways to obtain an independent
assessment of the quality of data generated in the project or of the final work product. Similarly, project
managers can use project scheduling software to compare the original project schedules and resource
estimates against the final schedules and resource utilizations. The point of the evaluation is not to cast
blame for delays or other problems, but rather, to identify aspects of the project that posed problems and
build on that knowledge when designing future projects.
Other tools are specifically designed to facilitate the evaluation phase of the quality system. These
include data validation, data quality assessment, technical system reviews or assessments, annual
program reviews, and quality system assessments. The evaluations described below, along with
recommended corrective strategies, may be carried out internally, by staff from the Office of Water, by
contractors under the direction of Office of Water staff, or by external parties, including the EPA Quality
Staff.
The tools described in Sections 4.3.4.1 - 4.3.4.7 are typically used as project assessment tools (e.g.,
validation of data gathered under a specific project, peer review of a project study design, etc.). Sections
4.3.4.8 and 4.3.4.9 describe quality system assessments and annual program reviews, which are typically
used as a program assessment tool (e.g., assessment of the quality system as it is performed by a
particular program office).
4.3.4.1 Internal Peer Consultation
Consulting with one's peers is a useful and important form of evaluation. It is also one that many people
practice already without giving it much thought. The process can range from an informal request for a
coworker to "take a look at this for me" to a more formal review. Peer consultation may go by other
names as well, including "peer input" or a "quality review" in some organizations. However, it should not
be confused with the formal "peer review" process established at EPA.
This form of review can apply to both technical and non-technical products, including correspondence.
Peers can provide needed editorial reviews, but they can also help identify other weaknesses in work
products. The scope and value of the review will depend on the reviewer's knowledge of the subject
matter and their own skills. Thus, if the goal is an editorial review, the reviewer should be a good writer or
editor. If the goal is an evaluation of the technical merits, then the reviewer should have a firm grasp of
the technical aspects of the material. As with all other types of assessments, it is important to ensure that
peers who are consulted for their input do not have any real or perceived conflict of interest. Generally,
assessors should have no direct involvement or responsibility for the work performed. However, peer
consultation may be characterized by a continued and interaction with scientific experts during work
product development. A common example of such peer input is the input received from workgroup
members during development of a product. Many OW products are developed through the efforts of a
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workgroup, which may include experts from other organizations, such as state and tribal representatives.
These workgroup members have an active, ongoing participation in developing the work product.
The Office of Water quality system encourages the use of peer consultation, but does not require it as a
formal process. However, whenever a peer is consulted, the comments from that consultation should be
maintained as a record of the consultation itself. This could be as simple as retaining a marked copy of
the product containing the reviewers comments, along with the reviewer's name and the date of the
consultation. Comments in an electronic form may serve the same purpose, provided that they can be
traced to the reviewer and the date.
Responses to Peer Consultation: As noted earlier, peer consultation is a useful, but not necessarily
formal, process. Therefore, no set responses are described here. However, common sense applies.
Obviously, typographical errors must be addressed and editorial comments should be considered in
revising the product. When major technical issues are identified, the reviewer and the developer or
author of the product should work together to determine if the issues are symptoms of a systematic
problem. Where needed, line management and the relevant quality system staff should be brought into
the process.
4.3.4.2 Formal Peer Review
Peer review is a formal Agency process that uses technically qualified peers (persons of equal or greater
skill to your own) to ensure independently the quality of scientific or technical work products that are
considered to be influential scientific information, highly influential scientific assessments, or otherwise
deemed significant enough to warrant an independent review. It is an essential Agency requirement
covering the review of these products and it is described earlier in this Chapter (see Section 4.1.2).
The Assistant Administrator is the ultimate decision maker and is accountable for implementing the Peer
Review Policy within the Office of Water. The Assistant Administrator may designate Office Directors and
Division Directors or other appropriate level line-managers as the front line decision makers.
Responses to Formal Peer Review: By its very nature, the peer review process is a formal one. In
general, every peer review comment must be formally addressed. Some comments may be addressed
by incorporating them or making the suggested changes, other comments may be addressed by careful
rebuttal, or by demonstrating that they are not relevant. The response to the peer review comments must
be documented in accordance with the Peer Review Policy.
4.3.4.3 Data Validation
As used in this quality management plan, data validation refers to an evaluation that is applied to primary
data collected under EPA's direction. The goal of data validation is to ensure that individual data
elements collected to support an EPA decision are valid in the context of the manner in which they were
collected. For sampling and analysis activities, "valid" data can be traced from the collection of a given
sample in the field, through the procedures employed by the laboratory performing the analysis, to a final
report of the results. Validation also examines the issue of "completeness" of a data set by determining if
results were produced for every sample that was collected, and if not, why not.
Data validation also involves a comparison of the sampling and analysis data against the acceptance or
performance criteria for the data. The criteria may be the result of the data quality objectives process, but
often are derived from the performance specifications of the sampling and analysis methods employed for
the specific project. For example, data validation may involve the examination of the quality control data
for various types of blanks, calibrations, and spiked sample analyses that are called for in many EPA
analytical methods, relative to the performance specifications in those methods. Validation also may
involve the comparison of the actual sample collection procedures with the sampling design described in
the planning documentation to determine the likelihood that the materials collected accurately represent
the source. The results of these evaluations may include a determination that the data meet the criteria,
that they do not meet the criteria because of poor performance by the samplers or the laboratory, or that
they do not meet the criteria because of problems inherent in the samples themselves.
Within the Office of Water, data validation activities are most likely to be employed for field sampling and
analysis projects, such as effluent guideline development studies. Because these activities involve
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standardized methods for sampling and analysis, data validation is generally performed in accordance
with a standard operating procedure that is specific to the analytical methodology.
Responses to Data Validation: Data validation typically identifies two distinct types of problems- those
associated with poor laboratory performance, including problems related to data entry or transcription,
and those associated with factors outside of the laboratory's control, including problems related to the
sample matrix itself or problems related to the sample collection and shipping processes. Whatever the
source of the problem, the goal of data validation is to obtain data that meet the quality required for the
specific project and to identify when that goal has not been met.
When the results of data validation efforts identify problems with laboratory performance, several forms of
corrective action may apply. For example, the laboratory may be required to reanalyze individual
samples associated with the performance problems at no additional cost to EPA. For problems that
indicate a more pervasive failure of the laboratory's quality system, it may be appropriate to negotiate a
more systematic solution to the problem, including changes to the laboratory's internal quality system. In
extreme cases, it may be necessary to take formal contract action against the laboratory. In the latter
examples, the response may not change the quality of the data already generated for the specific
samples or the project, rather, it may prevent future data quality problems.
When results of the data validation process identify problems that are outside of the control of the
laboratory, other forms of corrective actions may apply. For example, if the data validation results
indicate that the specified methods were either inappropriate or less than ideal for the samples that were
analyzed, the EPA project manager or project lead may elect to (1) determine and document the quality
of the available data relative to their intended use, (2) pay for reanalysis of samples using an alternate
method (if feasible), (3) identify alternate methods or techniques that can be used for future analysis of
similar samples, or (4) a combination of any of these actions. Other examples of problems outside the
laboratory's control include problems encountered during the collection or shipment of the samples
themselves. In such situations, similar forms of corrective action may apply.
Regardless of the specific problems identified, it is critical that the EPA project manager or project lead
determine the source of the problems so that EPA can take corrective actions. Therefore, the QAPP, or
equivalent documentation, must include a discussion of how such problems will be identified and
corrected. In some cases, part of the corrective action is to ensure that the data users understand the
limitations of the quality of the data that were produced, so that they can adjust their use of the data or
their conclusions about their meaning. Other cases may also involve corrective actions by the parties
collecting, shipping, or analyzing the samples.
4.3.4.4 Data Verification
As noted in Chapter 2, the Office of Water may make secondary use of data from other sources in
making environmental decisions. The data may take a variety of forms, ranging from primary data
generated by others with all the commensurate supporting information, to data compiled from literature
sources, to the results of modeling efforts, or even to data drawn from anecdotal sources. Whatever the
original source of the data, the Office of Water requires that reasonable efforts be made to verify the data
and to assess their quality to the greatest extent possible.
In the context of this plan, data verification refers to all efforts to determine if the data are properly
represented. This may include going back to the original published source of the information, rather than
relying on a summary or a citation in a review article. It may involve contacting the person who provided
the data and confirming the specific manner in which they were generated. If the data are the result of a
modeling effort, then the model should be examined to ensure that the results were generated as
intended. If the data involve calculations of descriptive statistics and the original data are available, then
the calculations may be spot-checked for accuracy. Where the data are primary data from some other
source, it may be possible to perform data validation procedures such as those described above. If the
Office of Water did not control the generation of those data, then it may not be possible to effect any
corrective actions to improve the quality of the results. Nevertheless, it is critical that the quality of
the data be known to the greatest extent possible and that any limitations to the use of the data be
identified and documented.
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4.3.4.5 Data Quality Assessment
A data quality assessment is a formal scientific and statistical evaluation to determine if the data obtained
from an environmental data operation are of the right type, quality, and quantity to support their intended
use. The need to conduct a data quality assessment is a project-specific decision and will be specified in
project-level quality system documents such as a Quality Assurance Project Plan (QAPP).
Two guidance documents may be used to assist in the data quality assessment process. These are
"Data Quality Assessment: A Reviewers Guide" (QA/G-9R) and "Data Quality Assessment: Statistical
Tools for Practitioners" (QA/G-9S). Data quality assessments are the responsibility of the project
managers, and the level of effort for the data quality assessment should be commensurate with the
project objectives and intended use of the data.
Data quality assessments often are conducted during and/or at the end of the data collection activity.
They may be performed during the project if the project manager has identified concerns about data
quality. The Project Manager, with assistance from the Quality Assurance Officer, is responsible for
determining the need for a data quality assessment. The process provides the necessary steps for the
statistical analysis of data to determine whether or not the data meet the objectives of the project and with
what level of confidence these data may be used. The result of a data quality assessment is a
quantitative statement of the limitations on the quality and potential uses of the data. If deficiencies are
found, potential technical and managerial causes are examined, and follow-up measures identified.
The results of the data quality assessment will be documented and provided to the Project Manager. The
Project Manager is responsible for reviewing the results, determining any corrective actions that are
needed, and confirming the implementation and effectiveness of those corrective actions.
Responses to Data Quality Assessments: Data quality assessments conducted during the project afford
an opportunity for ongoing corrective action. Data quality assessments conducted at the end of a project
provide a means of verifying the utility of the data, the need for a new project effort, or determination of
the feasibility of a long-term program.
The response to a data quality assessment may be to revise the systematic planning process for future
activities to avoid the data quality problems that were identified in the current projects. The response for
a specific project could include modifying the decision to match the quality of the data, or to collect more
data.
4.3.4.6 Technical System Reviews or Assessments
A technical systems assessment is a thorough, systematic, qualitative assessment of facilities,
equipment, personnel, training, procedures, record keeping, data validation, data management, and
reporting aspects of field and laboratory activities. Such assessments are also known as field and
laboratory audits, and focus on the actual environmental measurement data collection systems,
documentation, and the quality control data associated with those systems. A technical systems
assessment usually entails a site visit and an examination of sampling and measurement procedures,
personnel training, general laboratory cleanliness, support systems, equipment and facilities, calibration,
maintenance, and repair records, control charts, etc.
Given the costs associated with technical systems assessments, it is not practical to conduct them for
every data collection project. Moreover, since much of the sampling and analysis performed for the
Office of Water is conducted by a small number of contractors with multi-year contracts and operating
across a variety of projects, it may be more practical to rely on the results of routine pre-award and post-
award assessments of these contractors than to conduct project-specific reviews for every project. The
frequency of such assessments should be based on the schedule for the project and the length of the
contract.
Thus, under the graded approach, technical systems assessments may be reserved for specific projects,
based on the importance of the project, the risk of a decision error, the schedule for completion, and the
available resources. The need for and types and frequencies of technical system assessments should be
established and documented during the initial planning phase of the project.
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The most current version of the document Guidance on Technical Audits and Related Assessments for
Environmental Data Operations, EPA QA/G-7 (see the Reference section of this QMP), may be used to
plan and conduct an assessment, with modifications appropriate for the types of data that are being
collected. Technical systems assessments may be facilitated by the use of checklists geared to the types
of activities and analyses involved in the project. However, the assessors must be competent scientists
who are familiar with the particular data collection technology and procedures. Therefore, the assessors
must be selected on the basis of their demonstrated skills. Assessment of operations in biological
laboratories may require staff with different backgrounds and expertise than those who assess operations
in chemical laboratories. Similarly, assessments of field operations may require staff with different
backgrounds and expertise than those who conduct laboratory assessments. Where there are project-
specific concerns or anticipated problems, the Project Manager must provide that information to the
assessors.
Assessments will be scheduled and tracked by the Quality Assurance Officer, or designee, in consultation
with the Project Manager. The roles, responsibilities, and independence of the evaluation personnel, the
process for reviewing, reporting and responding to corrective actions, and the process for ensuring the
implementation and effectiveness of corrective actions can vary among projects. Therefore, these details
will be defined in a plan specific for each assessment. The results of technical systems assessment are
provided to the appropriate line and program supervisors.
Responses to Technical Systems Assessments: The results of a technical systems assessment may
point to pervasive problems that go beyond the results for a small number of the samples. Therefore, the
responses need to be on a similar scale. If a pre-award assessment finds significant problems, then the
EPA Project Manager must choose an appropriate response that is based on the project schedule. This
could include finding another contractor, improving communications between EPA and the contractor, or
an intensive effort by EPA to work with the contractor to resolve the problems now in order to meet the
project deadlines. The responses to the findings of an assessment conducted during the course of a
project should be designed to maximize the quality and quantity of the data to be delivered to EPA.
4.3.4.7 Performance Evaluation/Proficiency Testing
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
are commonly referred to as either performance evaluation (PE) or proficiency testing (PT) samples.
Proficiency testing 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. Proficiency testing samples 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.
Some state and federal programs require routine participation in a PT program, while others do not. The
Office of Water uses PT samples for projects involving important decisions or where multiple parties are
involved in data collection and data comparability is an issue.
For example, the Office of Groundwater and Drinking Water implements laboratory approval programs for
contaminants not covered under State certification programs. This includes the program for
Cryptosporidium monitoring under the Long Term 2 Enhanced Surface Water Treatment Rule and the
program for analyses under the Unregulated Contaminant Monitoring Rule - Cycle 2 (UCMR 2).
Laboratories that analyze source water samples for Cryptosporidium under the Safe Drinking Water Act
must be approved by EPA. This approval process requires that laboratories receive and properly analyze
a set of PT samples provided by OGWDW. Laboratories that successfully pass these initial PT tests are
then subjected to an on-site audit as described in the Technical System Review section above.
Laboratories that pass the audit and are approved by OGWDW are then required to participate in ongoing
(approximately quarterly) PT evaluations to demonstrate the laboratory continues to meet the
performance criteria of OGWDW Laboratory QA Program. Laboratories seeking to participate in the
UCMR 2 must successfully analyze PT sample(s) for each method for which they seek approval.
The Office of Science and Technology uses a similar approach to for laboratories that operate under their
multi-year contracts to support effluent guideline development studies conducted by the Engineering and
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Analysis Division. Prior to award of these long term contracts, candidate laboratories are required to
successfully analyze PT samples tailored to reflect the unique needs of each contract. Awarded
laboratories are then required to analyze PT samples on an ongoing basis as scheduled by EPA. The
exact frequency of these ongoing PT samples varies, depending on the volume of contract activity,
specific QA requirements of the projects being supported by the laboratories, and problems observed (or
not observed) with laboratory data submissions under the contract.
4.3.4.8 Quality System Assessments
Quality system assessments evaluate a specific quality system associated with environmental data
collection activities to either affirm the correctness and appropriateness of the quality system approach or
to identify areas where additional attention would bring significant benefits. Both external and internal
assessments are conducted on the Office of Water's quality system implementation.
The Office of Environmental Information (OEI) Quality Staff conduct independent quality system
assessments of the Office of Water quality system once every three years. EPA's Quality Staff Web site
provides resources and guidance regarding its quality system assessment process. These triennial
assessments comply with Section 7.a(3) of Order CIO 2105.0, which requires the Quality Staff to
"perform periodic management assessments of all EPA organizations conducting environmental
programs to determine the effectiveness of their mandatory quality systems and recommend corrective
actions." These Quality Staff assessments are referred to as external assessments because the review
is performed by staff outside of the Office of Water. Historically, the external review team has included
individuals from the Quality Staff, from other EPA Offices, and from Regions, who spend a week at the
Office of Water meeting with management, interviewing staff, and performing file reviews. The
assessments results, or "findings," are reported to the Office of Water through a findings report, and OW
responds to those findings by making improvements or adjustments to OW procedures and programs. It
is OW policy that all program offices participate in the external assessments. The OW QAM is
responsible for coordinating with OEI regarding the schedule for and approach to these assessments.
Each OW QAO is responsible for coordinating with QACs and managers within their office to facilitate the
assessments and ensure that all OW employees understand their roles and responsibilities for
participating in and supporting the assessments. OW managers are responsible for providing the Quality
Staff with access to the individuals and other resources necessary to conduct these assessments.
The Office of Water conducts annual self-assessments (referred to as internal assessments) of its quality
system implementation in OW program offices. OWs QMP is revised and reissued at five-year intervals,
and OWs internal assessment schedule is designed to correlate with this five-year schedule, such that
one of OWs five program offices is scheduled for internal assessment each year. This approach
provides feedback from each office for the five-year QMP update and complies with Section 6.4(4) of
EPA Order CIO 2105.0, which requires each EPA organization to assess the effectiveness of their quality
system at least annually. The OW QAM, assisted by the OW QAOs and senior OW management, select
the OW programs for annual internal quality system assessments. The self-assessment is usually led by
a QAO from one of the OW programs not being audited in a given year, with assistance from a technical
team selected by the designated lead QAO and approved by senior OW management. The assessments
results are reported to the National Program Manager, the OW Office Director, and other assessed Office
of Water managers s through a findings report. OW has developed Guidelines for Internal Assessment of
OW Quality System Implementation (see the References section of this QMP). These guidelines are
designed to promote consistency in performing internal assessments; they describe the procedures that
OW follows in planning, conducting, and following up on self-assessments of its quality system including
roles and responsibilities of assessors, experience and training for assessment personnel, independence
of assessment personnel, tools used in the assessment, and management review and response to
assessment feedback.
All assessments of the OWs quality system (whether internal or external) assess the quality
management structure, the quality management plan, and other office-wide quality system components,
to determine whether OW is implementing a satisfactory quality system. During the assessment, the
effectiveness of, and adherence to, the approved OW quality management plan, as well as the adequacy
of resources and personnel provided to implement the quality system will be evaluated by the
assessment team.
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The following issues are examined during quality system assessments:
Adherence to the Office of Water Quality Management Plan
Procedures for developing data quality objectives and other quality control acceptance criteria
Procedures for developing and approving quality assurance project plans
Quality of existing quality assurance project plan guidance and quality assurance project plans, e.g.,
is the guidance effective and do the plans meet the EPA requirements?
Procedures for developing and approving standard operating procedures
Adherence to new or revised standard operating procedures
Procedures, criteria, and schedules for designing and conducting assessments
Tracking systems for ensuring that the quality system is operating and that corrective actions
disclosed by assessments have been taken
Degree of management support
Responsibilities and authorities of the various line managers and the quality assurance officer for
carrying out the quality system
The level of financial resources and personnel devoted to implementing the quality system
Existence of appropriate quality system documentation and its conformance with the requirements of
the quality management plan.
Responses to Quality Systems Assessments: All quality system assessment results are communicated
to the assessed program's senior management in reports that may include recommendations for changes
to be made in processes to better comply with the OW Quality Management Plan. Senior management
closely reviews these reports and meets with the assessment team to clarify issues and
recommendations. Senior management determines the necessary actions, develops a corrective action
plan to address weaknesses disclosed in quality system assessment findings reports. The corrective
action plan includes milestones to use in measuring progress on corrective actions. Program office
managers are responsible for ensuring compliance with the approved corrective actions. Progress on
corrective actions taken in response to external audits is reported to the Administrator, Division and Office
Directors.
OWs Guidelines for Internal Assessment of OW Quality System Implementation, describe the roles and
responsibilities of assessors, managers, and QA staff in documenting and implementing corrective
actions related to internal assessments. The corrective action strategies described in these guidelines
also are used to address any issues identified in external Quality Staff assessments that require
corrective action. OWs Quality Assurance Annual Report and Work Plan (described in section 4.3.4.9
below) will summarize the results of, and response to any internal and external quality system
assessments conducted during the previous year.
4.3.4.9 Annual Program Review
Each year, the Office of Water is required to submit a Quality Assurance Annual Report and Work Plan
(QAARWP) that summarizes the quality management activities conducted during the preceding year. It
also reports on all reviews and audits conducted during the year, any actions taken in response to those
reviews, and plans for activities in the coming year. This QAARWP applies to activities in all Office of
Water program offices, divisions, and branches.
As part of the process of preparing the annual report, all programs involved in the collection of
environmentally-related data will review their quality system documents to determine if they remain
relevant to the mission of the program and if they ensure that data of known and sufficient quality are
used to support programmatic decisions. Ensuring that this review occurs is the responsibility of Branch
Chiefs and/or Division Directors responsible for implementing the program, with assistance from the
respective Quality Assurance Coordinators and Quality Assurance Officers.
At least annually, Office of Water management will meet with the Quality Assurance Manager, Quality
Assurance Officers, and Quality Assurance Coordinators to discuss adherence to the quality system and
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to identify areas where improvements can be made. Corrective actions will be developed to correct any
major deficiencies and outlined in the annual report and work plan.
4.3.5 Dispute Resolution
Disputes involved in the assessments are not uncommon. In the event that disputes arise concerning
assessment findings and corrective actions, resolution is sought at the lowest management level
practicable.
Sections 4.3.4.1 - 4.3.4.7 describe a variety of assessment tools that are aimed at assessing project level
activities. If a dispute arises between a member of the assessment team and a member of the assessed
organization, the issue should be resolved by the Project Manager, working with the Quality Assurance
Coordinator. If one or more of the organizations involved is a contractor, or grantee, the Contract Officer
Representative (COR) also must be engaged in resolving the dispute. If the dispute cannot be resolved
at this level, the issue should be elevated to the QAO and Division or Office Director responsible for
oversight of the project.
Sections 4.3.4.7 and 4.3.4.8 describe quality system assessments and annual program reviews that are
aimed at assessing how well OW programs are adhering to OW's quality system. The Office of Water
views these internal quality system assessments and program reviews as an educational opportunity to
enhance understanding of OWs quality system and how it can be applied in specific project areas.
Therefore, OW's quality system assessment procedures are designed to minimize disputes through a
collaborative approach and through frequent and open communication between all parties involved. If a
dispute arises between a member of the assessment team and a member of the assessed program
office, the issue should be resolved by the QAO that is leading the assessment activity and the Office
Director of the assessed program office. Should agreement not be reached at this level, the issue is
resolved by the Office of Water QAM and the Deputy AA for Water.
4.4 QUALITY IMPROVEMENT
One goal of this quality system is to afford all Office of Water programs with opportunities to improve the
quality of their products, including decisions based on environmental data. This QMP details OWs
quality system policy and processes, many of which facilitate improvement of OW programs and data
gathering activities. For example, regularly scheduled 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. Similarly, routine management meetings,
quality system assessments, and quality system training are examples of processes that provide
opportunities for identifying areas of improvement in OWs quality system.
4.4.1 Encouraging Staff to Identify and Implement Improvements to Quality
OW managers are encouraged to seek positive methods for ensuring adherence to OWs quality system.
All OW Branch Chiefs are expected to use their routine staff meetings as a forum for encouraging staff to
establish communications between customers and suppliers, identify process improvement opportunities,
and identify and propose solutions for problems.
4.4.2 Program-level Improvement
This QMP is approved by the National Program Manager, the Deputy Assistant Administrator for Water,
the Director of each OW program office, and the OW QAM, thereby demonstrating their commitment to
OWs quality system. OW management is responsible for ensuring that OW staff adhere to the
requirements of this quality system as documented in this QMP, and OWs quality system is constantly
being evaluated for effectiveness. This is facilitated through annual internal quality system assessments,
triennial external quality system assessments by OEI's quality staff, regular quality system training; and
OWs QA Annual Report and Work Plan.
The Deputy AA for Water meets regularly with the OW QAM to discuss adherence to the QMP and to
identify where improvements can be made. Included in these discussions are results of any assessments
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performed, stakeholder feedback on the quality system or on OW programs and products, staff
competence, process performance, and the status of preventative and corrective actions. Each Office
and Division Director routinely meets with their respective QAO to similarly discuss implementation of the
quality system and identify areas for improvement. Branch Chiefs and OW QACs conduct these
discussions at the Branch level. If major quality system deficiencies are identified at any of these levels,
the quality system team member working at that level proposes corrective action and works with their
corresponding line manager to ensure the corrective action is implemented, and finally assess if the
situation has improved. Deficiencies that are identified at the Branch or Division level that also may apply
to an entire program office or across the Office of Water are elevated to the QAO, QAM and senior line
managers as appropriate, and corrective actions are proposed, implemented, and improvements
assessed at that level as appropriate. These quality improvement initiatives are documented in OWs QA
Annual Report and Work Plan.
The annual OW internal quality system assessments provide another regularly scheduled opportunity for
review at the program level. As noted above, one program office is assessed each year so that all offices
are reviewed on a five year cycle. These internal quality system assessments are conducted with the
objectives of: verifying that the program office is complying with the requirements of OWs quality system
as documented in this QMP; identifying areas for improvement, and serving as an educational opportunity
to enhance understanding of OWs quality system and how it can be applied in specific project areas.
The triennial quality system assessments performed by OEI's Quality Staff also are used to identify
program and office level areas for improvement. As described above, action plans are developed to
address any deficiencies identified and ensure continuous improvement.
The OWQAM, in conjunction with each program office QAO, reviews OWs quality system and the QMP
each year to verify that it continues to be relevant to OWs mission and reflects current procedures.
Where necessary, aspects are modified to address evolving programs and changing needs, and the
modifications are documented in a revision to the QMP. For example, it is anticipated that this QMP will
be further revised in 2009 to reflect the Agency's new Quality Policy, EPA 2106.0, issued in October
2008. Revision of the QMP is indicated by the change in revision number and the date of the revision
included on the cover page and in the header information. All revisions are documented and posted in a
read-only format on OWs shared network drive and circulated by the AA via email to all OW staff.
4.4.3 Project-level Improvement
Office of Water staff at all levels are accountable for "continuous improvement" of the quality of their
products. The process of continuous quality improvement leads to a better and more responsive quality
system. The supervisors, project managers, and other technical staff have the most direct experience
with the quality system process and are encouraged to identify opportunities for improving the quality
system by contacting the Quality Assurance Manager directly or through discussion with their
management, their Quality Assurance Officer, or their Quality Assurance Coordinator.
As mentioned above, a variety of tools that are implemented as part of OWs quality system facilitate
improvement at the project level. Technical audits, peer reviews, and data quality assessments can
improve the quality for long-term data gathering projects, subsequent or follow-on projects, and new
projects that may be similar in nature. To increase the effectiveness of each data gathering project, OW
project managers, QACs and QAOs also are encouraged to conduct "debriefing" (or "wrap up") meetings
when a project has ended. Such meetings are used as an opportunity to review the QA/QC approaches
and documentation used for the project to determine how the plan could have been improved and how
similar ongoing projects may benefit from addressing these areas for improvement. The meetings
should address all aspects of the data gathering effort, including project planning, field and laboratory
procedures, data management, recordkeeping, and the appropriateness of the quality system. Such
meetings will assist project planners in identifying "lessons learned" and preventative actions that can be
included in future projects.
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Chapter 5
Planning Documentation
Another critical aspect of the Office of Water's quality system is that the planning process must be
documented. The three planning steps outlined in Chapter 4, section 4.1.1, result in various decisions
that will guide the implementation of an activity. Those decisions form the basis of a "plan" for the activity
and that plan is a quality system document.
Quality system documentation can take a variety of forms. Two of the most common forms are a Quality
Management Plan (QMP) such as this one, and a Quality Assurance Project Plan (QAPP) for an activity
involving environmental data. The reference section of this document contains the policies, procedures,
and guidelines for the Office of Water quality system. These QMPs and QAPPs do not apply to every
decision-making activity that may be conducted within the Office of Water, therefore, the Office of Water's
quality system explicitly recognizes that there are other formats in which the systematic planning of
activities can be documented and that content is more important than format.
The questions asked in the planning process and the answers that result must be documented in writing
in some fashion. Applying the graded approach, the format could be a checklist of questions and
answers, a simple "white paper" outlining the planning decisions, or more detailed, formal, quality
assurance project plan. One of the issues to be addressed during the planning phase of an activity may
be the nature of the quality system documentation that will be employed.
According to the EPA Quality Manual for Environmental Programs (see the References section of this
QMP), the eight elements of the planning process listed in Exhibit 5-1 must be documented. The specific
details of these elements are addressed in the three suggested planning steps described in Chapter 4.
Whateverform of documentation is used, it must address these elements of the planning process.
Exhibit 5-1
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, assessments, 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.
5.1 QUALITY ASSURANCE PROJECT PLANS
A commonly-used form of documentation for primary data collection activities is the quality assurance
project plan. A quality assurance project plan is a technical planning document that defines the
objectives of a project or continuing operation, as well as the methods, organization, and quality
management activities necessary to meet the goals of that project or operation. It serves as the blueprint
for implementing the data collecting activity, to ensure that the technical and quality goals of the operation
are met. It also provides the necessary link between the required data quality constraints and the
sampling and analysis activities to be conducted.
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EPA QA/R-5, Requirements for Quality Assurance Project Plans, identifies the data elements that must
be documented in a QAPP. Guidance for preparing QAPPs is available in EPA QA/G-5, Guidance for
Quality Assurance Project Plans. (See the references section of this QMP.)
The quality assurance project plan must be approved by the management and quality system staff of the
organization conducting the project (e.g., the Project Manager, Branch Chief, and Quality Assurance
Coordinator) prior to any data gathering or use, as described below in Section 5.7 and shown in Exhibit 5-
2 of that section.
5.2 EQUIVALENT DOCUMENTATION
Order CIO 2105.0 requires that the quality system require quality assurance project plans or "equivalent
documents" for all projects and tasks involving environmental data. Such documents must be approved
by the management and quality system staff of the organization conducting the project (e.g., the Project
Manager, Branch Chief, and Quality Assurance Coordinator) prior to any data gathering work or use,
except under circumstances requiring immediate action to protect human health and the environment or
operations conducted under police powers.
The allowance for "equivalent documents" is critical to successful planning and documentation of many
activities covered by this quality management plan. For example, the Office of Water funds a variety of
grants to States, Tribes, and public and private organizations that advance the overall mission of the
Office. 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 grants may 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. In addition,
the EPA Order now addresses the secondary uses of data, as described in Chapter 2, whereas the
traditional quality assurance project plan requirements are clearly designed to address primary data
collection activities and may not adequately address secondary data.
Therefore, the Office of Water quality system explicitly provides for a graded approach to the
documentation of environmental data activities. The most stringent approach to such documentation
remains a quality assurance project plan. As part of the planning process, project managers may decide
to specify that another form of documentation will be employed. In some cases, it may be determined
that a formal QAPP or equivalent documentation is not necessary at all, depending on the anticipated use
of the data. Section 5.7 describes the process for documenting approval of these decisions and for
preparation and approval of equivalent documentation.
5.3 DOCUMENTATION FOR PRIMARY DATA COLLECTION
Unless the planning process specifically identifies a rationale whereby it is not necessary, a quality
assurance project plan will be prepared for all primary data collection activities by EPA or at EPA's
direction by contractors. The quality assurance project plan will conform to the basic format outlined in
the most recent Quality Staff requirement documents available at the time the plan is prepared (e.g.,
QA/R-5, see reference section). When identified during the planning stages, such quality assurance
project plans may be written at the broadest possible level, e.g., covering data collection across related
sites for a given project, and supported by additional documents that are site-specific, or address
additional details not covered in the quality assurance project plan.
The quality assurance project plan must be approved and in place prior to the start of data generation or
use. It is the responsibility of the Project Manager to ensure an approved quality assurance project plan
is in place prior to the start of data generation or use. A generic checklist for reviewing quality assurance
project plans is included in Attachment A. It outlines 24 elements of a quality assurance project plan and
asks questions about how the plan addresses various aspects of each element. This checklist may be
used as is, noting those aspects and elements that do not apply to a given environmental data collection
project, the checklist may be modified for project-specific needs, or another approach to reviewing quality
assurance project plans maybe employed, so long as that approach and the results of the review process
are documented.
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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. That decision may employ the graded approach described
throughout this quality management plan. However, regardless of the approach chosen, the
documentation must be reviewed and approved by the relevant Office of Water management and quality
system staff prior to the start of data generation or use, as described in Section 5.7.
5.4 DOCUMENTATION FOR SECONDARY DATA COLLECTION AND USE
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. EPA's
ability to assess the quality of the results may vary. For example:
Data may be primary data from another project. It may be possible to perform a detailed assessment
of the data relative to the current use. In this instance, the quality system documentation could be
written in a form very similar to a quality assurance project plan, with less focus on controlling of the
generation of the data, and more focus on the assessment relative to the current use.
Data may be collected from various sources in the literature and the underlying results may not be
available in any form. In this instance, the quality system documentation could be in any format that
outlines the steps that EPA will take to assess the results. That assessment might focus on obtaining
copies of the original publications rather than relying on review articles. It could describe the process
that EPA will use to compile and compare data from various sources, to ensure consistent units of
measurement are used, etc.
Data may be presented to EPA from some outside source as a fait accompli, e.g., the results of an
industry-sponsored survey. The quality system documentation could focus on EPA's activities to
assess how the data were collected, to verify the responses with the original sources, etc.
Whatever format is used for the quality system documentation, it should address the eight elements listed
in Exhibit 5-1. The documentation must clearly identify all the instances in which the quality of the data
cannot be controlled or assessed. If existing data will be used, the project planning team should review
Chapter 3 of EPA QA/G-5, Guidance on Quality Assurance Project Plans (see the References section of
this QMP). Chapter 3 provides guidance to assist in determining whether or not existing data should or
should not be used, how to evaluate existing data relative to project needs, and how to address the use
of existing data in QA project plans.
5.5 INFORMATION QUALITY GUIDELINES
In October 2002, EPA finalized Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility
and Integrity of Information Disseminated by the Environmental Protection Agency (EPA/260R-02-008).
Commonly referred to as EPA's "Information Quality Guidelines" or "IQGs", these guidelines were
developed to comply with guidelines issued by the Office of Management and Budget (OMB) in response
to the Information Quality Act of 2002. EPA's IQGs contain the Agency's policy and procedural guidance
for ensuring and maximizing the quality of information we disseminate and complement EPA's Quality
Management System for assuring the quality of EPA's products and information. The IQGs also outline
administrative mechanisms for pre-dissemination review of information products, and describe
mechanisms that enable the public to seek and obtain, where appropriate, information disseminated by
the Agency that does not comply with EPA or OMB guidelines.
"Information" generally includes any communication or representation of knowledge or position/policy
such as facts or data, in any medium or form. This includes "preliminary" information that EPA has
endorsed or adopted, and also conclusions or facts drawn from or based upon other existing information
(secondary uses of information). Information generally includes material that EPA disseminates from a
web page. However, not all web content is considered "information" under the IQGs (e.g., certain
information from outside sources that is not adopted, endorsed or used by EPA to support an Agency
decision or position).
In general, EPA disseminates information to the public when one or more of the following criteria are met:
EPA prepares the information and distributes it to support or represent EPA's viewpoint, or to
formulate or support a regulation, guidance, or other Agency decision or position.
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EPA distributes information prepared or submitted by an outside party in a manner that reasonably
suggests that EPA endorses or agrees with it; if EPA indicates in its distribution that the information
supports or represents EPA's viewpoint; or if EPA in its distribution proposes to use or uses the
information to support a regulation, guidance, policy, or other Agency position
EPA reviews and comments on information distributed by an outside party in a manner that indicates
EPA is endorsing it, directs the outside party to disseminate it on EPA's behalf, or otherwise adopts
or endorses it.
In order to implement the IQGs, OW performs pre-dissemination review of OW activities and products
that are subject to the guidelines. OW uses a "Predissemination Review Checklist" to facilitate and
document this review. The Predissemination Review Checklist is initiated and prepared by the Project
Lead/Project Manager, and forwarded to the Division Director for review. After review and signature by
the Division Director, the checklist is forwarded to the OW IQG point of contact. The Division Director
must sign the checklist; it goes to the OW IQG point of contact. The IQG point of contact forwards a
signed version acknowledging receipt to the program office Quality Assurance Officer (QAO). The QAO
is responsible for maintaining the fully signed version of the checklist. A copy of the Office of Water
Information Quality Guidelines: Pre-Dissemination Review Guidance and Checklists, version 2.2
(January 10, 2003) is available on the Office of Water intranet.
Information that is adopted, endorsed, or used by EPA to support an Agency decision or position is
generally considered "information" for the purposes of the IQG and should be subject to pre-
dissemination review. The pre-dissemination review procedures are intended to provide assurance that
quality has been built into the information we disseminate.
Work products that are undergoing peer review are not considered to be disseminated under EPA's IQGs
because they are dynamic documents that are subject to change and, therefore, do not represent EPA's
final decision or position. These products should contain the following disclaimer while they are
undergoing the peer review process:
"This information is distributed solely for the purpose of pre-dissemination peer review under
applicable information quality guidelines. It has not been formally disseminated by EPA. It does not
represent and should not be construed to represent any Agency determination or policy."
In cases where the information is highly relevant to specific policy or regulatory deliberations, this
disclaimer should appear on each page of the work products. Peer review products that are
disseminated are subject to the Agency's IQGs. Refer to the IQGs and Section 1.3.4 of the Peer Review
Handbook for detailed information.
5.6 DOCUMENTATION FOR CONTRACTS AND ASSISTANCE AGREEMENTS (GRANTS AND
COOPERATIVE AGREEMENTS)
Chapter 9 describes how the Office of Water will incorporate quality system requirements into
procurements and financial assistance agreements, including contracts, assistance agreements (grants
and cooperative agreements), performance partnership agreements, and interagency agreements that
involve the collection or use of environmental data. The documentation associated with contracts and
assistance agreements (i.e., grants and cooperative agreements) often is derived from other
organizations within EPA, including the Office of Acquisitions Management. Attachments C, D, and E
contain forms and checklists that are used to document activities associated with contracts, grants, and
assistance agreements. The manager with responsibility for the contract, grant, or agreement and the
corresponding member of the quality system staff are responsible for completing these forms and
checklists, as well as complying with all other procurement or assistance requirements.
5.7 PREPARATION AND APPROVAL OF QUALITY SYSTEM DOCUMENTATION
The Branch Chief has the ultimate responsibility for ensuring that the appropriate quality system
documentation is prepared and approved for any project within the Branch, by signing off on the Quality
Assurance Review Form for Extramural Projects (Contract WAs, DOs, and TOs) provided in Attachment
D and the QAPP. In general, the quality system documentation should be prepared by staff involved in
the planning process. The project staff (which may include a contractor or grantee involved in the
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planning process) should prepare a draft of the quality system documentation that incorporates the
decisions about data quality and assessment that resulted from the planning phase of the project. The
general process for preparing and implementing a quality assurance project plan is shown in Exhibit 5-2.
Exhibit 5-2
Preparation and Approval of Quality Assurance Project Plans
Project Planning Team Identifies:
- The project goals and objectives
- The project schedule, resources, budgel, and milestones
- Tha type and quantity of data needed lo make Ihe decision
- The data quality objectives or acceptance criteria that apply
Project Planning Team
recommends whether a QAPP
should be prepared and forwards
recommendation to the QAO
QAO
determines if
QAPP or
equivalent
documentation
is required
Yes
Project Planning Team Prepares
(or oversees Ihe preparation of)
QAPP or equivalent documentation
Project planning team documents
justification that a QAPP or equivalent is
not needed
QAO reviews draft QAPP.
equivalent documentation or
justification
No (revise QAPP or equivalent)
No (revise justification)
Quality system staff and line
management signs plan and
provides implementation guidance
Project staff implements the plan
Audit or periodic review of plan
implementation
Results are integrated into project
report, including implications or
deviations from plan
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This process also addresses the use of equivalent forms of quality system documentation. As part of the
planning phase of the project, the team must decide what form of quality system documentation is most
appropriate for the data collection activities. As noted elsewhere, the structure of a quality assurance
project plan is built around the generation of primary data using field and laboratory procedures and it is a
well-established and effective means in which to document those activities. However, the project team
may wish to employ another form of quality system documentation for other types of data gathering
activities, including those involving secondary uses of data, where the scope of the project does not
warrant a quality assurance project plan (e.g., a small grant), or where the data collection activities are
not directly associated with a decision by the Office of Water (e.g., educational activities or other outreach
projects). In some cases, it may be determined that a formal QAPP or equivalent documentation is not
necessary at all, depending on the anticipated use of the data.
If the project team decides that a quality assurance project plan is not required, then that decision is
presented to the Quality Assurance Officer for concurrence. The Quality Assurance Officer will consult
with the Quality Assurance Coordinator for the project and notify the Project Manager of the decision.
If the QAO concurs with the project planning team recommendation regarding the use of equivalent
documentation, the project planning team documents prepares the equivalent documentation for
review by the QAO. If the equivalent documentation is acceptable, the QAO approves the equivalent
documentation prior to project initiation and provides implementation guidance to the Project
Manager.
If the QAO concurs with the project planning team recommendation that no QAPP or equivalent
documentation is necessary, the project planning team documents the justification for this decision
and forwards the justification to the QAO for review and approval. If the justification for this decision
is acceptable, the QAO approves the justification and provides implementation guidance to the
Project Manager.
The Quality Assurance Review Form for Extramural Projects (Contracts, WAs, DOs, and TOs) discussed
in Section provided in Attachment D to this QMP is used to document the approval of these decisions.
The draft quality assurance project plan (or equivalent documentation) is reviewed by the Quality
Assurance Coordinator for the project. If the Quality Assurance Coordinator played an active role in
preparing the plan, then to ensure some level of independence, a Quality Assurance Coordinator from
another Branch should perform the review. In addition, depending on the nature of the project, it may be
reviewed by the Quality Assurance Officer and management in the relevant program office (the need for
such higher level reviews should be identified during the planning process). As needed, it is returned to
the project staff for revisions. Once approved by the Quality Assurance Coordinator, it is sent to the
Branch Chief for review. Issues identified during the review by management should be addressed by the
quality system staff, with input where needed from the project staff. Final approval of the QAPP or
equivalent documentation is indicated by the signatures of the project's technical leader, the Branch
Chief, and the Quality Assurance Coordinator. Where the planning process identifies the need for review
and approval by higher levels of management, the documentation will be submitted to the Quality
Assurance Officer and the Division Director as well. For projects involving contractors and particularly
sampling and/or laboratory contractors, the quality assurance project plan must be reviewed and
approved by the contractor's management and quality system personnel as well, since they are going to
be bound by the constraints of the plan.
Contractors and grantees may prepare quality assurance project plans, or equivalent documentation, for
the projects in which they are involved and may also provide support to EPA in preparing quality
assurance project plans for use by others. However, the essential planning steps, including establishing
the data quality objectives and/or the acceptance or performance criteria, must be carried out by EPA. In
other words, if EPA is making the environmental decision, then EPA decides the quality of the data
needed to support that decision.
5.8 STANDARD OPERATING PROCEDURES
Procedures that OW staff routinely use during the collection, evaluation, or use of environmental data
within a program or project should be formalized as a standard operating procedure (SOP). The
approach presented in this section for developing, approving, and implementing SOPs for use in new and
ongoing projects is intended to provide OWwith the following benefits:
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Consistency in performance
Improved data comparability, credibility, and defensibility
Reduced errors
Increased efficiency in performing tasks, thus reducing costs
SOPs are commonly used for field and laboratory operations. For example, good laboratory practices
and good management of field sampling operations include the development and use of SOPs for all
routinely used field sampling and laboratory analysis activities and the housekeeping that supports them
(e.g., laboratory data management). Such SOPs facilitate the comparability of data generated at different
times or by different field or laboratory staff. SOPs are also applicable to other processes that are
performed repeatedly by multiple staff. For example, the Engineering and Analysis Division, within OWs
Office of Science and Technology operates a Clean Water Act Alternate Test Procedure (ATP) program
in which stakeholders may submit requests to use a modified or new test procedure in lieu of the
approved procedure promulgated in the Federal Register. Applicants must conduct specific tests and
submit specific types of data to demonstrate the comparability of their proposed ATP, and EPA reviews
the ATP against these criteria. Because the requirements for submission and review are constant, the
Engineering and Analysis Division has implemented an SOP for processing ATP applications.
SOPs serve not only to ensure that routine tasks are performed correctly and consistently but also to
provide a basis for staff training programs. Therefore, SOPs should be written by individuals that perform
(or have performed) the procedures and reviewed by one or more individuals with appropriate training
and experience in the process to address all salient details.
5.8.1 Identifying Operations that Require SOPs
During the planning phase of any program or project, OW managers should identify tasks or processes
that will be performed repeatedly or by multiple staff, and develop procedures for performing these tasks.
Where feasible, existing procedures should be modified and tailored to meet the specific needs of the
new program or project based on lessons learned from earlier experiences or knowledge of changes
needed to address the project-specific requirements. If the project involves routine procedures that are
already documented in an SOP, and if those SOPs are fully applicable to the current project, the existing
SOPs may be identified and adopted. A common example of this situation would be the use of a
laboratory SOP for analysis of a specific set of pollutants using a specific method with specific quality
control measures. Methods can be included in the SOP, either in the body of the document or as an
appendix. If the referenced method is not followed precisely, the SOP must include an addendum to the
method that clearly identifies the changes to the method. Again, laboratory methods are a common
example of a situation in which existing analytical methods may be used with minor modifications to
achieve specific project objectives. Planned use of SOPs for a project that involves data collection or use
should be documented in the QAPP. This can be accomplished by (1) clearly stating in the QAPP that
SOPs will be developed for specific processes, and identifying those processes, or (2) if the SOPs are
already available at the time the QAPP is developed, by listing in the QAPP the title, date, and if
applicable, revision number, of the SOPs that will be used in the project.
5.8.2 Preparation, Review, Approval, and Use of Office of Water SOPs
Within OW, SOPs may be prepared to support activities at various levels, including the Office level (i.e.,
across OW), the Program Office level (i.e., the Immediate Office, AIEO, OGWDW, OST, OWM, and
OWOW), the Division level, or the project level. Roles and responsibilities for development, review,
approval, and use of SOPs are summarized below.
Office-wide SOPs: At the Office level, the AA for Water (or designee), is responsible for development,
revision, and removal of SOPs. The AA, in conjunction with the OWQAM, identifies procedures that
would benefit from use of SOPs and, as necessary, identifies qualified individuals to develop and review
the written procedures. Once finalized, the AA and the QAM are responsible for reviewing and approving
the SOPs. Approved SOPs are posted in a read-only format on OWs intranet Web site and circulated by
the AA via email to all OW staff. All OW staff are responsible for implementing the new procedures. All
OW managers are responsible for ensuring that SOPs are followed by staff in their organization.
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Program Office and Immediate Office SOPs: Each program office may tailor (i.e., add additional
information to) the office-wide SOP to meet their needs, as long as the overall office-wide requirements
are retained. If such program office SOPs are developed, they must be approved by the Office Director
(or designee) and the QAO for that program office. Approved SOPs are posted on the program office
intranet, shared directory, or other location accessible to all staff and circulated in a read-only format by
the Office Director via email to all program office staff. All program office staff are responsible for
implementing the new procedures. Each line manager within the program office (i.e., the Office Director,
each Division Director, and each Branch Chief) is responsible for ensuring that program office SOPs are
followed by staff within their organization.
Division and Project Level SOPs: At the division or project level, the respective OW Division Director or
Project Manager, in conjunction with the Division QAC, works with technical staff from their organization
and support team to identify procedures that would benefit from the use of SOPs.
Division Directors and their division QACs are responsible for review and approval of division level
SOPs. Approved division level SOPs are posted in a central location accessible to all staff (e.g., a
shared directory) and circulated in a read only format by the Division Director (or designee) via email
to all division staff.
OW Project Managers are responsible for review and approval of SOPs applicable to their specific
projects. The Division QAC is not responsible for review and approval of project-specific SOPs, but
the SOP should be included or referenced in the project QAPP, which is reviewed and approved by
the QAC. Approved project level SOPs are circulated in a read-only format by via email to all project
staff by the EPA Project Manager. If a project-specific web site exists, the Project Manager will utilize
that web site as a means for maintaining the official, approved read-only version of the SOP. If such
a web site does not exist, the PM will create and maintain a centralized binder containing approved
SOPs. This binder will be maintained in a location that is physically accessible to all project staff.
If an SOP is developed and used by a contractor supporting the project, the SOP must be reviewed
and approved by the contractor's Program, Project, Work Assignment, or Task Order Manager. As
with OW project level SOPs, contractor SOPs should be included or referenced in the contractor's
QAPP, which is approved by the contractors' QA Officer. (The contractor's titles will vary, depending
on the type of contract vehicle.)
Within OW, all staff members in the OW Branches and Divisions are responsible for notifying their quality
assurance coordinator (QAC) and management (i.e., Branch Chiefs and Division Directors) of the need
for new or revised SOPs. QACs and line managers are responsible for considering these requests and,
where appropriate, responding to these needs by developing new SOPs or revising existing SOPs. If the
requested SOPs are applicable to an entire program office, rather than a single division, the QACs and
line managers are responsible for notifying their Office Director and QAO of the request, and where
necessary, assisting the Office Director and QAO in addressing it. Similarly, if requested SOPs are
applicable across OW, rather than within a single program office, the QAO and Office Director are
responsible for notifying the QAM and AA of the request, and where necessary, assisting in them in
addressing it.
5.8.3 Revision and Removal of SOPs
SOPs should be reviewed annually for currency, and updated or removed as appropriate. Changes to
existing SOPs and removal of obsolete SOPs follow the same line of responsibility and distribution as
described above. Obsolete SOPs will be removed the central locations in which they were originally
placed when current (e.g., intranet locations, shared drives).
All changes to existing SOPs should be identified on a change page at the end of the SOP.
5.8.4 SOP Format and Content
In 2009, OW is adopting a new standard format for its SOPs. A template for this format will be made
available on OWs intranet; the template includes the following minimum elements:
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A header that identifies
> The SOP source (e.g., "Office of Water," "Office of Wastewater Management," "Standards Risk
Management Division," etc)
> The version and date of the SOP (e.g., "Original, February 2009," "Revision 1, August 2009," etc.)
The unique title of the SOP, clearly centered at the top of the first page
A "Purpose" section that briefly describes the purpose of the SOP
An "Applicability" section that identifies the activities, projects, or circumstances to which the SOP
applies and the individuals who are responsible for implementing the SOP
A brief "Summary" section
A "Definitions" section that ensures all parties using the SOP interpret terms and definitions
consistently
A "Responsibilities" section that summarizes the responsibilities of individuals or classes of
individuals (e.g., the Project Manager, field sampling staff, quality system staff, etc.) with respect to
the processes described in the SOP
A "Procedures" section that provides a clear description of the steps and processes that are to be
followed
A change page for all revised SOPs that lists the changes since original publication, with the dates of
the changes.
Depending on the nature of the SOP, it may be desirable to include additional elements. For example,
laboratory SOPs typically include sections on: sample handling and preservation; interferences; safety;
equipment, materials, and reagents; instrument calibration; calculations; and references. Regardless of
the exact format used, all newly developed SOPs should include the minimum elements listed above,
presented in a form that is useful to anyone performing the work.
Note that this new template will not be retroactively enforced because revision of existing, time-tested
SOPs simply to comply with a new formatting standard is not a valuable use of OW's QA resources. The
litmus test will be the usefulness of the SOP.
Version Control
The procedures described above are designed to be consistent with International Standards Organization
requirements for quality management systems (i.e., ISO 9000) and include specific procedures to ensure
that all staff have access to the appropriate versions of the approved SOPs. These measures include the
use of a header that identifies the version and date of the SOP, the use of specified centralized locations
for these SOPs in a read only format (e.g., a designated intranet site, a designated binder, etc.), and the
use of email announcements to applicable staff that new, revised, or removed SOPs are available and
the location in which those SOPs are permanently stored.
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Chapter 6
Management of Documentation and Records
The OW Quality System is designed to be an integral part of all activities within the Office of Water. An
essential element of this Quality System is proper records management according to guidance provided
by both the Agency and the Office of Water. Proper records management is not only the law and the
right thing to do, it is mandatory within the Office of Water, and as such is your responsibility as an
employee.
All OW staff are expected to take records management seriously, know and keep up to date with the
correct policies and procedures and follow them in a timely manner. Records management applies to all
the information you handle, regardless of format (i.e. paper, electronic, microfiche, video, etc.). A basic
requirement is that all the information you handle must be properly identified and labeled as a record, a
nonrecord or a personal paper. EPA Records Schedules are the legal documents guiding "proper
handling" of your information. There are many Schedules covering information considered as records.
There is also one Schedule telling you how to handle Nonrecords as well as one telling you how to
handle Personal Papers. All staff are encouraged to check the OW Records Management intranet Site at
intranet.epa.gov/ow/records on a regular basis for the most updated policies, procedures and tools.
Records Management Contacts have been designated for every OW Program Office and Division and for
some branches. These contacts serve as a resource for you, should you have questions. A list of
current Records Management Contacts is also available at the OW Records Management intranet site.
The OW Records Management Workgroup has responsibility for developing standards and procedures
for the management of all records in OW, including those of the Quality System. This plan advocates the
integration of quality system documents with OW Records Program policies and procedures.
In addition, this plan recognizes the utility and increased use of electronic records of all kinds, including
quality system records. Thus, the records management provisions of this plan apply equally to records in
all media, including paper and electronic records.
6.1 QUALITY ASSURANCE RECORDS SCHEDULES
Presently, four schedules, shown in Exhibit 6-1, have been identified as being most relevant for handling
OW Quality Management information.
Exhibit 6-1
EPA Record Schedules Relevant to the OW Quality Management System
Records
Schedule
No.
006
145
147
185
Business
Reference
Model Code
301-093
304-104-02
304-104-06
304-104-06
Business
Function
Program
Monitoring
Program
Development
Quality
Management
Quality
Management
Title
Program Management Files
Program Development Files
Information Quality Guidelines (IQG) Requests for Correction (RFC)
and Reconsideration (RFR) process
Collections of Quality Assurance Project Plans (QAPPs)
As other EPA records schedules for Quality Systems documents are identified by the OW records
custodians and Records Management Contacts or Records Liaison Officer, they will be published in this
Quality Management Plan for uniform application by all OW Headquarters and Regional Quality Systems.
In the meantime, the general guidelines presented below will continue to be applicable for all OW Quality
Systems.
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6.2 CONFIDENTIALITY
Particularly at the project level, Office of Water staff may have access to information that is considered to
be proprietary or confidential by one or more parties. Examples include proprietary or confidential
business information (CBI) collected from a regulated entity, enforcement-sensitive information collected
during the course of enforcement proceedings by EPA or the Department of Justice, and information from
Tribes and States. There are specific statutory requirements and policies that govern the use and
disclosure of such information and are beyond the scope of this quality management plan. The Office of
Water requires that all confidential records be maintained according to those requirements and policies.
Office of Water staff must be aware of the presence of confidential information in relation to quality
system documentation. For example, some information that is normally included in a quality assurance
project plan may include CBI relating to the industrial processes to be sampled. If such CBI is included in
the quality assurance project plan, then the entire plan is subject to the statutory CBI protections and may
not be placed in files that are not approved for CBI, or handled by staff without CBI training. Similarly, the
documentation of reviews and evaluations could contain CBI or other sensitive information that is not
suitable for general distribution.
Therefore, in order to minimize the number of quality system documents that must be retained under
special circumstances, project managers are encouraged to identify the likelihood that information
collected during the project will require special handling during the up-front planning effort. In planning
the quality management activities for the project, reasonable efforts should be made to segregate
confidential or sensitive information in documents such as quality assurance project plans. For example,
if confidential or sensitive information is essential to the plan, it may be more practical to include the
information in a separate appendix or attachment. The sensitive portion is then maintained separately
from the bulk of the plan. Here again, a graded approach should be employed to balance the need for
the information in the quality system documentation against the resources required to protect
confidentiality.
6.3 REVIEW, APPROVAL, AND RELEASE OF WORK PRODUCTS
The Office of Water is committed to ensuring the quality of all work products, and the strategies described
throughout this QMP are designed to promote quality throughout all OW activities leading to the
development of final work products. All OW project managers and project leads are fully responsible for
reviewing, authenticating (i.e., verifying the content is accurate), and approving new and revised products
produced under their projects. As part of this process, each project manager and project lead is
responsible for ensuring that all records on environmental data and information comply with applicable
EPA policies, such as policies for identifying locational data. (Any such policies that apply to the project
also should be identified in the QAPP or equivalent documentation.) The Office of Water follows the
Office of Public Affairs (OPA) communications product development and review requirements and
content management system for preparing, reviewing, issuing, using, and revising documents and
records. The OPA communications product development and review requirements can be found at
http://www.epa.qov/productreview/index.html.
The OPA requirements apply to all of the following Office of Water work products:
New or significantly revised materials that have policy implications and are targeted to specific
audiences (e.g., industry groups, community organizations, educators, consumers, public officials) or
general public sectors, including:
> Agency initiatives
> Recommendations for public action
> Products that inform and educate the public about the environment
> Cross-program or multi-regional products that address specific topics
> Materials produced by and for the Agency through contracts and in cooperation with partners
> Publications such as fact sheets, brochures and pamphlets (unless pre-approved by the Media
Relations Office or Regional Press Office as parts of a press kit)
> Web content (note that concepts for new, redesigned or reorganized Web content must be
approved by the OPA Office of Web Communications, but that draft Web content must only be
approved by the applicable AAship or Region's Web Content Coordinator)
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> Previously approved documents being posted in Adobe Acrobat format (PDF) on the Web more
than one year after their original publication date require concept approval.
Exhibit banners, brands, specialty items, videos, posters, bookmarks, folders, radio or TV public
service spots, and multimedia products
Program brands: Specialized artwork/graphics representing specific programs, projects, teams, task
forces, workshops, etc.
Conference materials such as brochures and handouts
Jointly authored products: Non-technical products authored jointly by EPA and assistance recipients
(grantees) for distribution to the public. Joint authorship implies EPA acceptance of content; however,
these documents are not to communicate policy, guidance, internal operation procedures, or
regulations. Document front covers must clearly indicate the joint author relationship between EPA
and the assistance recipient by displaying identifiers of both organizations
Translated documents: All products translated from one language to another are subject to review.
Materials not listed above are not subject to OPA communications product development and review
requirements, but are subject to Office of Water review requirements as described below.
Editorial updates to existing materials that do not change the orientation or intent of the product or
represent new policy are reviewed by the Project Manager or Project Lead responsible for its
development.
Draft Web content is subject to review by the Office of Water's Web Content Coordinator, but not by
OPA.
Fact sheets, newsletters, and leaflets produced on pre-approved templates must be entered in the
Agency's product tracking database, PROTRAC, for OPA oversight, but they are not reviewed by
OPA. Instead they are reviewed by the Project Manager or Project Lead, the Branch Chief, and the
Division Director responsible for release of the materials.
Previously approved documents to be posted on the World Wide Web as Adobe Acrobat (PDF) files
within one year of their original publication date do not require OPA review. However, these
documents must be reviewed for currency by the Office of Water product review official. As noted
above, PDF documents posted more than one year following their original publication date must be
submitted as a Web concept for OPA approval.
Legal documents, notices, and testimony:
> Congressional testimony. All Congressional testimony documentation is reviewed by the
Assistant Administrator. Congressional testimony is also coordinated with and reviewed by the
EPA Office of Congressional & Intergovernmental Relations.
> Legal briefs and opinions are coordinated with and reviewed by the Office of General Counsel.
> Federal Register publications (e.g., notices, notices of proposed rulemaking, final rules, etc.) are
reviewed in accordance with the Agency's regulatory action procedures.
> Requests for proposals follow review and approval requirements as specified by the Office of
Acquisition Management.
> Meeting plans and agendas are reviewed and approved by the Office of Water manager or
project lead responsible for organizing the meeting.
Technical material:
> Documents requiring specialized knowledge targeted to technical audiences are reviewed by the
project manager or project lead responsible for their development and the applicable OW Branch
Chief. Technical reports used to support rulemaking, such as Technical Development
Documents, are subject to review by the applicable OW Division Director and program Office
Director. They are also subject to review by the Office of General Counsel (OGC) in conjunction
with their review of the rulemaking package. Memos, such as policy memos to regions and
states, are reviewed the same manner as technical reports.
> Documents subject to a formal public comment period or review by the Science Advisory Board
or Science Advisory Panel, or that are independently peer-reviewed follow the Agency
procedures established for each of these forms of review.
> Databases are controlled and thoroughly tested prior to deployment in accordance with
requirements specified QAPP. All OW databases are compliant with OEI data standards and
verification and validation protocols. Applications deployed to the public and hosted within the
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National Computer Center must comply with the Agency Standard Application Deployment
Checklist (ADC).
Exceptions: technical documents with broad and direct policy, political, social or ethical
implications, or those used to introduce a new Agency policy or requirement, must be reviewed
by OPA. In addition, there is no "technical material" exemption for Web pages. All Web pages are
subject to review by the appropriate Web Content Coordinator to ensure they are designed
properly and meet all requirements.
Reports:
> Advisory Committee statements or reports; internal policy statements, memoranda and
directives; and official correspondence
> Inspector General reports
> Congressional reports
> Verbatim conference proceedings
Materials produced entirely under grants, Memoranda of Agreement, and Cooperative Agreements
Speeches are drafted in the Office of Water program offices and reviewed by the Deputy
Communications Directory and the AA.
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Chapter 7
Quality System Training
It is Office of Water 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 the Office of Water's quality
system.
7.1 OFFICE OF WATER'S QUALITY SYSTEM TRAINING PROGRAM
Following approval of this quality management plan, all Office of Water staff will receive training to explain
the fundamental components of the quality system documented in the plan. In addition, all staff who
perform tasks related to the generation, management, and/or use of environmental data, including Project
Managers, laboratory analysts, field personnel, and data processors, need to understand quality
management procedures and principles, and will participate in training related to the generation of
environmental data.
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 environmentally-related data-gathering activities during the mid-year and annual
personnel performance evaluations. The Individual Development Plans of all Office of Water quality
system staff, supervisors, and managers will include appropriate quality system training requirements and
standards.
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 understanding of the importance of
the quality system, their responsibilities as managers of data collection activities, and specific Office of
Water quality system policies and procedures.
7.2 ROLE OF THE QUALITY ASSURANCE MANAGER
The OW Quality Assurance Manager is responsible for identifying annual training needs for the office,
disseminating information regarding available training opportunities for staff and management, and
arranging Office-wide quality system training, with guidance and assistance from the Office of
Environmental Information Quality Staff. Specifically, the Quality Assurance Manager will ensure that the
following are addressed:
All new employees receive introductory QA training
Supervisors have the introductory training and any in-depth training that is routinely offered
Project managers and project leads (and equivalent) will have a minimum of 8 hours of quality system
training, that includes the data quality objective (DQO) process and QAPPs
The Quality Assurance Manager, Quality Assurance Officers, and Quality Assurance Coordinators
will have a minimum of 24 hours of training
The necessary training is made available to all grantees and potential grantees including State,
Tribal, local and other government body personnel and other eligible grantees
All trained staff members take a refresher course every three years
Any necessary arrangements are made in response to special training requests by EPA, State,
Tribal, local, and other governmental representatives
The OW Quality Assurance Manager is responsible for arranging or providing for the training needs
identified by the Divisions and Program Offices. Specific organizational training needs will be addressed
annually in the Quality Assurance Annual Report and Work Plan.
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7.3 TRAINING REQUIREMENTS
Quality system training requirements can be met by attending seminars developed by EPA Quality Staff
or through equivalent in-house training. The EPA Quality Staff has made training materials available on
the internet so that staff may use the materials to take training or develop training courses to meet
mission-specific needs.
The Office of Water's training program incorporates a graded approach relative to the functions
performed by the various groups of personnel. Exhibit 7-1 of this section outlines the minimum quality
system training requirements for the various groups of personnel. These core courses may be modified
to address specific program needs. Additional quality system training needs identified by the Divisions,
Program Offices, and Quality Assurance Coordinators will be provided when needed.
Supervisors and Quality Assurance Coordinators, with necessary assistance from Quality Assurance
Officers and the Quality Assurance Manager, are responsible for identifying and providing program-
specific quality system training. Minimally, supervisors will assess and summarize their needs annually,
and will provide the listing to the Quality Assurance Coordinators for inclusion in the Quality Assurance
Annual Report and Work Plan.
Exhibit 7-1
Minimum Training Requirements by Position
Position
Managers (Branch Chiefs,
Division
Directors)/Supervisors
Work assignment managers,
project managers, project
officers, lab personnel, and
field personnel
Office of Water quality system
staff (QAM, QAOs, and QACs)
All Office of Water staff
involved in the generation or
use of environmental data
All other Office of Water staff
QA Training Requirements
Overview of the Office of Water quality system
Orientation to Quality Assurance for Managers and Supervisors
Overview of Information Quality Guideline requirements
Overview of EPA's Peer Review requirements
Overview of the Office of Water quality system
Introduction to Quality Assurance Project Plans
Introduction to Data Quality Objectives
Overview of Information Quality Guideline requirements
Overview of EPA's Peer Review requirements
Overview of the Office of Water quality system
Introduction to Quality Assurance Project Plans
Introduction to Data Quality Objectives
Overview of Information Quality Guideline requirements
Overview of EPA's Peer Review requirements
Overview of the Office of Water quality system
Introduction to Quality Assurance Project Plans
Introduction to Data Quality Objectives
Overview of Information Quality Guideline requirements
Overview of EPA's Peer Review requirements
Overview of the Office of Water quality system
Overview of Information Quality Guideline requirements
Attendance at the courses will be recorded, and attendees will receive a written record from the Quality
Assurance Manager or instructor after completion of a course. The Quality Assurance Officers will
maintain records of the quality system training taken by personnel in each Program Office. These
records will include, but not be limited to, a list of the courses offered, the names of attendees, and a
listing of all participating organizations.
7.4 CONTINUING EDUCATION AND REFRESHER TRAINING
The Office of Management and Budget's Office of Federal Procurement Policy issued a federal policy
(OFPP Policy Letter 05-01) requiring continuous learning for all members of the civilian acquisition
workforce. This policy requires all Contracting Officer Representatives (CORs) to obtain 40 Continuous
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Learning Points (CLPs) every 2 years. The Office of Acquisition Management's CLP Guidance provides
additional information on CLPs.
Training regarding the Quality Management Plan provided by OWs Quality Team and training on the
Agency Quality System by EPA's Quality Staff both qualify for CLPs. Courses offered by the EPA Quality
Staff are available on the Quality Staff web site and listed in Exhibit 7-2. These course apply to quality
system professionals (i.e., QA Managers, QA Officers, and QA Coordinators), program and project
managers (i.e., Office and Division Directors, Branch Chiefs, project managers, project leads, and
contracting officer representatives), and technical staff. The courses are offered by the Quality Staff or
may be presented by OWs Quality System Team. When offered by OWs Quality System Team, the
courses are supplemented with program-specific activities or material to provide context, emphasis, and
relevance to OW programs.
Exhibit 7-2
Training Course Offered by EPA's Quality Staff
Course Title
Assessing
Quality Systems
Detecting
Improper
Laboratory
Practices
Interpreting
Monitoring Data
Interpreting
Multivariate
Analysis
Introduction to
Data Quality
Assessment
Introduction to
Data Quality
Indicators
Description
One day course designed to prepare those who will either
assess or be assessed as part of an EPA quality system
or EPA-supported quality system.
One and a half day course that presents tools and
techniques for identifying improper practices in
environmental laboratories during routine technical
assessments. Identifies "red flags" in each step of the
assessment process that can indicate improper
laboratory practices.
Half day course on how to apply statistics to monitoring
data. Teaches the need to incorporate planning into
monitoring activities, the importance of
representativeness, how to graphically view data. Also
provides insight into the complexities of statistical
analyses of monitoring data.
Half day course covers multivariate analysis techniques
to explore relationships among several variables in an
effort to understanding an environmental problem.
One day course demonstrates how to perform a data
quality assessment (DQA) and provides detailed
information on graphical and statistical tools. Intended for
managers or analysts that either use (analyze) the data
or review the use of data by others.
One day (or optional half day) course discusses the
principal data quality indicators (DQIs): precision, bias,
representativeness, comparability, completeness, and
sensitivity. Also includes information on data verification,
validation, and integrity.
OW Beneficiaries of the Training
Quality
System
Staff
V
V
V
Managers/
Supervisors
V
V
V
V
Technical
Staff
V
V
V
V
V
V
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Course Title
Introduction to
Data Quality
Objectives
Introduction to
EPA Quality
System
Requirements
Introduction to
Quality
Assurance
Project Plans
Introduction to
Quality
Management
Plans
Overview of the
EPA Quality
System
Description
One day course teaches participants the basic elements
of the Data Quality Objective (DQO) process, including
the Agency's quality system, the elements of the DQO
process, how the process applies to a regulatory program
at EPA, and how to interpret consequences of potential
decision errors. Includes team sessions to apply the
process to real-life examples.
One day course intended to introduce the concepts of
quality management. Contains an overview of EPA's
quality system and basic QA concepts and a description
of application of these concepts to environmental
programs involving the collection or use of data.
One day course designed with a "how to" approach for
individuals who write, review, and/or approve QAPPs.
Provides an overview of QAPP development, which
stresses the need for systematic planning and EPA's
graded approach to project plan development, and
describes in detail, the 24 elements of the QAPP.
Half day course introduces the EPA policies and
specifications of QMPs. Presents information that
satisfies Order CIO 2105.0 and EPA Requirements for
Quality Management Plans (QA/R-2)
An abbreviated version of the Introduction to EPA Quality
System Requirements course. Focuses on the policies
and specifications of the EPA quality system and specific
elements that managers and project staff must address to
comply with EPA policy.
OW Beneficiaries of the Training
V
V
V
V
V
V
V
V
V
V
V
V
V
V
The Office of Water QAM is working with other members of OW's Quality System Team to develop a
Strategic Training Plan that will ensure that all Office of Water staff receive appropriate training to support
their role in implementing OWs quality system and the Agency's Strategic Plan. This Strategic Training
Plan will describe OWs requirements and processes for ensuring quality-related competencies, including
continuing education and refresher training. When completed, the EPA QAM will post it to OW's intranet
site and send an email to all OW staff and managers of its availability and their roles and responsibilities
for implementing and complying with the plan.
7.5 TRAINING FOR GRANTS AND CONTRACTS
Grant recipients or contract personnel involved with environmental data generation and use also must
have the necessary quality system training to successfully complete their grant or contract tasks and
functions. Contract and grant project managers are responsible for ensuring that the quality system
training requirements are described in the organization's approved quality system documentation. Work
assignment quality system requirements may be delineated in the Request for Proposal, the statement of
work, and/or the work assignment. The Quality Assurance Manager will ensure that an overview of the
quality system training course will be provided in addition to providing the financial assistance
management and contract administration training courses.
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Chapter 8
Information Systems
The Office of Water recognizes that the success of the national water program depends on information
systems that meet the needs and quality standards of internal and external customers. The Office of
Water has developed a variety of information systems ranging from general support systems and major
applications with broad applicability across to the Office of Water to smaller, specialized, and often ad
hoc, information systems that may include small databases, spreadsheets, and tools that are used by
project staff and citizens. The graded approach to quality management also applies to all these
information systems.
8.1 General Support Systems and Major Applications
The Office of Water ensures that general support systems and major applications meet customer needs
and quality standards in four ways.
Adhering to all Federal (laws, Presidential Decision Directives and Memorandums, and Office of
Management and Budget guidance) and EPA standards pertaining to hardware, software, system
development, and data. These standards can be found at the Office of Environmental Information
(http://intranet.epa.qov/oeiintra/imitpolicy/index.htm') as the IM/IT Policy Resources.
Adhering to all EPA data standards to reduce confusion caused by multiple methods of representing
the same information across EPA regulations, reporting requirements, and databases (CIO 2133.0).
Working closely with the Office of Water Information Management Project Management Office and
the Office of Environmental Information on all phases of system development, improvements, and
updates.
Working closely with the Office of the Chief Financial Officer (OCFO) for implementation of the OCFO
Information Quality Guidelines.
Senior management and information system staff from all Office of Water programs coordinate and direct
information system development, improvements and updates through participation on the Office of Water
Information Steering Committee.
The goal of these efforts is to achieve appropriate levels of quality and consistency in the way data are
generated, compiled, stored, and disseminated across all EPA water programs. This will ensure more
complete and adequate data with which to make management decisions.
8.2 COMPLIANCE WITH APPLICABLE INFORMATION SYSTEM STANDARDS
All efforts to develop, improve, or update information management systems within the Office of Water will
comply with EPA Directive 2100, Information Resources Management Policy Manual (CIO 2100.0). The
efforts will include a systematic and comprehensive dialogue among the data providers, data and system
users, and system developers, prior to the design of the system. The Office of Water relies on this
directive and on other policies and guidance from the Office of Environmental Information to translate
applicable Federal laws, Presidential Decision Directives and Memorandums, and Office of Management
and Budget guidance into policy that the Office of Water can use to direct information systems
development.
Highlights of the EPA directives and guidance that the Office of Water will follow for information systems
development, operation, and improvement are identified below. Office of Water personnel involved in
information systems are required to familiarize themselves with EPA directives and guidance and use any
that is applicable to their efforts.
During the operational phases of any information management systems, Office of Water will comply with
requirements within EPA Directive 2100 Information Resources Management Policy Manual and the most
current version of the EPA System Life Cycle Management Policy (CIO 2121.0). Compliance with the
applicable information resource management standards will ensure that all hardware and software
configurations are tested prior to use, perform as expected, and meet user requirements.
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All information management system development, modification and enhancement (DME), and
operations and maintenance (O&M) efforts will comply with the EPA System Lifecycle Management
Policy (CIO 2121.0).
In addition, the Office of Water will comply 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.
Managers and staff will comply with all hardware and software standards delineated in EPA's
Information Technology Architecture Road Map. The road map 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 supporting computing platforms
and network connectivity between computing platforms, as well as the systems software and related
products that interconnect computing platforms and make them operate.
The Office of Water also requires that sufficient data documentation be provided with a data set to assist
potential data users when evaluating the utility of the data set for their purposes. This data documentation
includes the original information on data quality associated with the data as well as any supplementary
information on the direct application of the original data, known restrictions, or cautions which will
facilitate the secondary use of the data.
8.3 COMPLIANCE WITH EPA DATA STANDARDS
The EPA Data Standards Program is established and documented in EPA Data Standards Policy (CIO
2133.0). The Office of Water promotes the use of data standards to help information managers and the
public assess environmental information more quickly and accurately, improve data sharing with
stakeholders, maximize the use of resources and improve data integrity. Within the Office of Water,
adherence to data standards policy is accomplished through the application of the data standards.
The Office of Water actively participates on EPA and intergovernmental committees and/or workgroups,
that actively pursue the development of comparable data elements and formats for data used by EPA
water programs.
8.4 OFFICE-WIDE DATA SYSTEM COORDINATION AND OVERSIGHT
The Office of Water's Senior Information Officer (SIO) is responsible for the Office of Water compliance
and implementation of all Agency information system standards and policies outlined above. The SIO
coordinates and provides oversight of information system activities in the water program offices through
the Office of Water Information Management Officer (IMO) involving the Information Steering Committee
(ISC). The Information Management Project Management Office supports the ISC.
The Office of Water Information Steering Committee is comprised of the SIO, IMO and Deputy Office
Directors from all OW Headquarters program offices. The ISC is responsible for overseeing and
coordinating information management activities within the Office of Water. The SIO, IMO and ISC work
together to ensure that the Office of Water information systems are developed, operated and improved in
full compliance with applicable Agency information systems directives, policies and data standards.
EPA's information system and data standards directives and policies apply to all EPA organizations and
personnel, including contractors, Senior Environmental Employee (SEE) program participants, and other
personnel assigned to EPA who design, implement, and maintain information management systems for
Office of Water and EPA.
8.5 OTHER INFORMATION SYSTEMS
Individual projects within the Office of Water may involve smaller, specialized, and often ad hoc,
information systems that could include small databases, spreadsheets, and tools. Many of these are
based on commercial off the shelf (COTS) software that may only be employed for short periods. As
such, the system design guidance, life cycle requirements, and other information system standards may
not be applicable and may do little to ensure the quality of those systems. Therefore, under the graded
approach, the project planning team, the Branch Chief (or Associate Division Director), and the OW IMO
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are responsible for identifying when such "minor" information systems will be employed and documenting
all efforts by the project staff to ensure their quality.
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Chapter 9
Procurement and Financial Assistance
It is Office of Water policy that quality system requirements be explicitly addressed when acquiring items
and/or services that may result in or relate to the collection and/or use of environmental data. 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,
and 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.
9.1 CONTRACTS
Contracts are used when the principal purpose of acquiring the service or item is for the direct benefit or
use of EPA. Obtaining services through contracting constitutes the largest extramural activity of the
Office of Water. The Office of Water conducts procurement functions in accordance with the Federal
Acquisition Regulations (FAR), and generally accepted business practices for the acquisition process.
The FAR was amended in 1999 to address contract quality systems requirements on a government-wide
basis. The FAR contract clause at 52.246-11, Higher-Level Contract Quality Requirement (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 E4-2004, Quality
Systems for Environmental Data and Technology Programs - Requirements with Guidance for Use, as
an acceptable standard.
Office of Water program management staff and quality management staff play active roles in assisting the
contract management staff in defining the quality system requirements for contracts. Contracts involving
the collection of either primary or secondary environmental data 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 Project Officer (also known
as the Contracting Officer's Representative, or COR), submits a request stating the desired service,
measures the quality of the service, and accepts the service. The Contracting Officer provides the means
of obtaining a contract and enforcing the provisions of the contract. 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 is 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 EPA's Contracts Management Manual (CMM, August 2007)
specifies the required training, experience, and workload limitations for an individual to serve as a PO.
OW adheres to these specifications. Two major tools that ensure that adequate service is provided under
a contract are (1) a detailed statement of work (SOW) or performance work statement (PWS) and (2)
quality system documentation that includes reviews of the work performed. Exhibit 9-1 summarizes the
difference between an SOW and a PWS.
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 an SOW or PWS that will accurately define the minimum
acceptable requirements for service. This is the first step in the procurement process and helps ensure
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that services produce results or products of acceptable quality. The PO must succinctly state OW's
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 is essential to a mutual understanding of what the
expectations are and how quality will be defined. Methods used to determine quality (e.g., audits,
quarterly interviews, random inspections, etc) should be explained prior to project implementation. The
Office of Management and Budget (OMB) Office of Federal Procurement Policy (OFPP) Pamphlet No. 4,
circular A-76, A Guide for Writing and Administering Performance Statements of Work for Service
Contracts, (1980) provides good guidance for writing PWSs and implementing QA surveillance plans.
Additional information can be found in A Guide to Best Practices for Performance-Based Service
Contracting which was released by OMB in March 1996 as a replacement for Pamphlet No. 4. The newer
guidance incorporates much of the general information from Pamphlet No. 4, includes additional
information about the concepts of performance based services acquisitions (PBSA), but omits much of
the useful details regarding how to accomplish PBSA. Therefore, both documents are recommended as
a tool for writing PWSs.
Exhibit 9-1
What is the Difference between a PWS and SOW?
Federal Acquisition Regulation (FAR) Section 37.102, states: "Performance-based contracting is the
preferred method for acquiring services. When acquiring services, including those under supply
contracts, agencies must... use performance-based contracting methods to the maximum extent
practicable."
A PWS describes the requirement in terms of measurable outcomes versus the method by which
services should be performed. A PWS is the means of defining technical contract requirements
that most closely adheres to the principles of Performance-Based Services Acquisition (PBSA).
The PWS is supported by a Quality Assurance Surveillance Plan (QASP) that defines the
government's expectations, how the performance requirements (products or services) will be
monitored and evaluated, and the incentives and remedies applicable to the work.
SOWs are the more traditional and historically more common means for the government to
define requirements for services. Normally, an SOW describes the requirement in terms of the
specific services to be performed. This approach does not easily support the principles of PBSA.
If you want a contractor to provide car waxing services, an SOW would define exactly how to
perform the waxing (e.g., apply wax to each car with a soft cloth or sponge, using a circular hand
motion, remove wax with a clean dry cloth using clean dry cloth), whereas a PWS would define
the required outcome (e.g., each car shall be waxed to present a uniform glossy appearance and
reflect 1 inch letters placed 5 inches from it, and the completed shine shall be free of wax build
up and smudges).
Chapter 46 of EPA's Contracts Management Manual (April 7, 2004) (CMM) provides guidance for the
inclusion of higher-level contract quality requirements in applicable solicitations and contracts. For EPA,
higher-level quality requirements apply to the collection, generation, use, or reporting of environmental
data, and the design, construction, or operation of environmental technologies. CMM Chapter 46
contains instructions for the Contracting Officer Representative (COR) and the Contracting Officer (CO)
regarding use of the QA Review form for contact actions, and provides a variety of "tailored" clauses that
the CO can incorporate into contract actions to enable tailoring of acceptable quality standards to meet
specific Agency needs. These procedures apply to solicitations and contract actions that involve a
significant change to the Statement of Work. As specified in CMM Chapter 46, the COR will complete the
QA Review form documenting the quality requirements for the acquisition or contract action. The CO will
then incorporate QA Review form requirements into the solicitation and contract via applicable clauses.
Attachment B of this QMP contains Directions for Contracting Officer's Representatives, Directions for
Contracting Officers, and Contracts Clause and Tailoring Language from CMM Chapter 46 Appendices
46.1 A, 46.1B, and 46.1C, respectively.
The Office of Water uses two QA Review forms to document QA requirements for contract actions.
Attachment C of this QMP provides an example of the QA Review Form for Extramural Projects
(Contracts) that is used to define and approve the quality assurance requirements that will be required for
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new contract acquisitions. This form, which is part of the Procurement Initiation Notification (PIN)
package, is completed during the solicitation and award of new (or follow-on) contracts that involve
environmental data and/or information collection. A different QA Review form, known as the Quality
Assurance Review Form for Extramural Projects (Contract WAs, DOs, and TOs) is used to define and
approve the quality assurance requirements that will be required for specific work assignments, delivery
orders, and task orders under an existing contract. This document is used after a contract has been
awarded and throughout implementation of the contract. An example of this two-page form is provided in
Attachment D of this QMP.
Office of Water quality system staff 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 Section 46.1.5.2 of CMM Chapter 46, a member of the Office of Water quality system staff at the
appropriate level will assist the Project Officer with development of the Technical Evaluation Criteria and
serve as a member of the Technical Evaluation Panel for procurements over $500,000, in cases where
quality system requirements are applicable to the procurement. Quality Assurance Coordinators or
Quality Assurance Officers from the relevant program will generally fulfill this role.
The Office of Water has developed Guidelines for Incorporating Quality Assurance into Procurement and
Management of Office of Water Technical Support Contracts to assist personnel in understanding the
process for reviewing, approving, and managing the quality of extramural agreements. These guidelines
are available on OWs intranet.
Final approval of deliverables and services is the responsibility of the EPA COR with possible assistance
from quality system staff at the appropriate level within the Office of Water (e.g., the Quality Assurance
Coordinator). Deliverables and services that do not meet established requirements shall be identified,
documented, and corrected by the contractor.
Quality system documentation associated with Office of Water contracts should be included in EPA
Records Schedule 185 (Quality Assurance Project Plans), as described in Chapter 6 of this Quality
Management Plan.
9.2 FINANCIAL ASSISTANCE
9.2.1 Assistance Agreements (Grants and Cooperative Agreements)
Assistance agreements are used to support or stimulate activities that are not principally for the direct
benefit of EPA. 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.
All assistance agreements originating within the Office of Water 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 5730.1A1, Policy and Procedures for Funding Assistance Agreements, July 18, 2000
40 CFR Part 30 (30.54), Grants and Agreements with Institutions of Higher Education, Hospitals, and
Other Non-Profit Organizations
40 CFR Part 31 (31.45), Uniform Administrative Requirements for Grants and Cooperative
Agreements to State and Local Governments
40 CFR Part 35, State and Local Assistance
OW 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 official
project records (see Chapter 6). As stated in Managing Your Financial Assistance Agreement, it is
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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 that will produce data of sufficient
quality to meet project objectives and will minimize loss of data due to out-of-control conditions or
malfunctions. If the applicant has an EPA-approved quality assurance project plan and it covers the
project in the application, then the applicant need only reference the plan in his/her application. The
quality assurance project plan must be acceptable to the Award Official in order to receive a grant award.
In keeping with the graded approach described throughout this plan, Office of Water policy requires that
all parties receiving EPA grants/financial assistance under which environmental measurements (primary
or secondary data) are produced or used include either a quality assurance project plan that has been
prepared in accordance with EPA QA/R-5 (see the References section), or equivalent quality system
documentation. The level of documentation must be established by Office of Water staff when planning
for the grant or financial assistance. (Refer to Chapter 5 for details regarding the decision to use and the
approval of equivalent documentation.)
The grant applicant is responsible for preparing the quality system documentation, which is then reviewed
and certified by the Quality Assurance Officer or his/her designee before environmental measurements
(primary or secondary data) are collected. For financial assistance grants under the purview of Regions,
the Regional Quality Assurance Officer or his/her 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 may be reviewed and cosigned by the Office of Water Quality Assurance
Officer.
If an applicant is unfamiliar with EPA and the Office of Water quality requirements, the Project Officer
should direct the applicant to the appropriate quality staff in the Office of Water or 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
CFR 30.54].
If an application is from a State or Tribal government (except for a wastewater treatment construction
grant) the applicant must define his/her plans for completion of the necessary quality system
documentation [see 40 CFR 31.45].
All other applicants must submit quality system documentation with their applications or as specified
in the term and condition of the assistance agreement.
The applicant's quality system documentation shall indicate whether the assistance involves
environmental data generation or use. The applicant must include a description of the program or project
associated with the assistance with Standard Form 424. The description contains five parts:
1. Objective
2. Results or Benefits Expected
3. Approach
4. General Program/Project Information
5. Quality Assurance Requirement
The decision on whether a grant or cooperative agreement involves environmental data generation or use
is determined by the Office of Water Project Manager in consultation with the Quality Assurance Officer
and after review of the narrative description provided with the Standard Form 424. The Programmatic
Certification-Authorization to Award an Assistance Agreement form is signed and dated by the Office of
Water Project Manager.
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.
The applicant's quality system documentation will be reviewed and approved as a condition for award of
any assistance agreement. The quality system documentation is be submitted as part of the application. If
the quality system documentation is not submitted as part of the application and the Office of Water
decides to fund the project, then the Office of Water will include a term and condition in the assistance
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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
work involving environmental programs until the Office of Water Project Manager informs them that the
quality system documentation has been approved. Exhibit 9-2 summarizes key steps for ensuring that
QA policies are implemented in financial assistance agreements.
Exhibit 9-2
Key Steps for Ensuring Compliance in Implementing QA Policies in Financial Assistance
Agreements (including Grants and Cooperative Agreements)
Step 1: The Grant PO determines if a QAPP or equivalent documentation is needed. A "yes" or "no" determination must
be made and indicated on the Funding Recommendation in the Integrated Grants Management System (IGMS). If
a QAPP is needed but not prepared, the PO must include a term and condition in the programmatic conditions of
the funding recommendation. The QAO (or designee) is available to assist the PO in determining if a QAPP is
needed. When a "no" determination is made, the QAO must concur with the decision. This is accomplished by
including the QAO (or designee) as an approver in IGMS.
Step 2: The Grants Specialist, based on the PO's QA determination (and the QAO's concurrence for a "no" determination)
incorporates the appropriate financial agreement condition(s) into the award.
Step 3: Once the final agreement has been awarded, the PO works proactively with the recipient to ensure that the QAPP
is developed, completed, and submitted to EPA for review and approval. The PO and QAC share responsibility for
review and approval of the submitted QAPP. Both the PO and QAC must sign the QAPP approval page. The PO
is responsible for maintaining a copy of the sighed QAPP with the project file.
The QAC is responsible for helping the PO discuss QA requirements with a recipient during development of the
QAPP. In particular, for complex monitoring projects, a scoping meeting between the recipient, PO, and QAC is
recommended. In accordance with Agency policy, the QAPP must be submitted and approved before initiation of
any data gathering activities
Step 4: The recipients progress reports and products must address the QA requirements. It is the PO's responsibility to
understand the recipients approved quality system and to make sure that the recipient is following planned QA
procedures. The PO must ensure that the recipient's products include quality system documentation established in
the project work plan.
9.2.2 Performance Partnership Agreements and Grants
When States or Tribes receive funds from the Office of Water, these funds may be provided through
performance partnership agreements (PPAs) or performance partnership grants (PPGs) between the
State or Tribe and the applicable EPA Region (i.e., the Region in which the State or Tribe is located and
to which the Office of Water has delegated responsibility for program implementation). In such cases, the
PPAs and PPGs should be used as a mechanism to define the quality system requirements for the effort
and to establish the respective quality management roles and responsibilities of the State or Tribe and
the EPA Region. OW maintains oversight responsibility for quality system implementation as described
in Chapter 3 of this QMP.
Quality system documentation associated with PPAs and PPGs should be included in EPA Records
Schedule 185 (Quality Assurance Project Plans), as described in Chapter 6 of this Quality Management
Plan.
9.3 INTERAGENCY AGREEMENTS
Interagency agreements that are funded by the Office of Water should include quality system
documentation requirements in the agreement. Because the Office of Water cannot unilaterally impose
such requirements, these requirements must be negotiated into each agreement. Policies and
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administrative procedures governing interagency agreements are defined in Chapter 5 of Managing Your
Financial Assistance Agreement. The Office of Water quality system requirements related to
environmental data apply to all activities funded by the Office of Water through interagency agreements.
Cooperative agreements that will produce environmental measurements must adhere to the quality
system documentation requirements at 40 CFR 30.503. These standards must be included explicitly in
all cooperative funding agreements.
All interagency agreements with environmental measurement activities which the Office of Water funds,
or participates in, will include quality system documentation. Where the Office of Water 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, those procedures
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 the
appropriate the Office of Water Quality Assurance Officer before environmental measurements (primary
or secondary data) are collected. All proposed cooperative funding agreements will be reviewed to
determine the applicability of quality system requirements as defined in Order CIO 2105.0. This
determination will be documented by the Office of Water quality system staff within the Program Office
providing the funding.
Where a quality management plan is required, the plan will be prepared in accordance with the
specifications provided in the most current version of EPA Requirements for Quality Management Plans
(QA/R-2). This document describes the quality system implemented by the party involved in the
environmental program. The plan defines the approving officials of the plan, which, at a minimum will be
the Office of Water Quality Assurance Manager.
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References
This section provides reference sources for a variety of materials to assist Office of Water staff and
managers in implementing the Office of Water Quality System. These references include:
A series of documents developed by the EPA Quality Staff that describe the various requirements of
the overall EPA quality system and 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/qualitv/qa docs.html. 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.
Guidance documents developed by the Office of Water to aid OW staff and mangers in complying
with OW quality system requirements. These include OW Information Quality Guidelines, guidance
for performing internal quality system assessments, and guidance for incorporating QA into the
procurement and management of OW contracts. All guidance documents developed by the Office of
Water are available on the OW intranet.
Quality-related Agency policies, such as the Agency's peer review policy and the Agency's
information quality guidelines.
Detailed information for each of these reference materials is provided below.
Requirements Documents
All of the documents that describe formal quality requirements for EPA organizations are defined "EPA
Directives," and are policy documents. These include:
Order CIO 2105.0, 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 CIO 2105-P-01 -0, May 2000, EPA Quality Manual for Environmental Programs. This
document describes the specifications for satisfying the mandatory quality system defined in EPA
Order CIO 2105.0.
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 (with Reissue Notice May 2006), EPA Requirements for Quality
Management Plans. QA/R-2 is the policy document containing the specifications and requirements
for Quality Management Plans for organizations that receive funding from EPA. These specifications
are equivalent to Chapters of EPA Quality Manual CIO 2105-P-01-0.
EPA QA/R-5, March 2001 (with Reissue Notice May 2006), 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. These specifications are equivalent to Chapters of EPA Quality Manual CIO 2105-P-01-0.
EPA QA/R-5 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. Most of the
guidance documents are designated with the letter "G" followed by a number. Two of the guidance
documents provide case studies, and are designed with the letters "CS" followed by a number. The
documents that are available in final form at this time are listed below, beginning with the "G" documents,
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References February 2009
Page 64
followed by the "CS" documents. Those that do not have the letter "G" designation are identified by their
EPA publication number at the end of this list.
EPA QA/G-1, November 2003 (with Reissue Notice January 2008), Guidance for Developing Quality
Systems for Environmental Programs. QA/G-1 provides guidance on developing and documenting
the elements of a functional quality system in organizations that carry out environmental data
operations within, or on behalf of, EPA.
EPA QA/G-3, March 2003, Guidance on Assessing Quality Systems. This document provides
guidance on assessing the adequacy and effectiveness of an environmental quality system.
EPA QA/G-4, February 2006, 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.
EPA QA/G-4D, September 2001, 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-5, December 2002, 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-5G, March 2003, Guidance for Geospatial Data Quality Assurance Project Plans. QA/G-
5G provides guidance on developing Quality Assurance Project Plans for geospatial data projects.
EPA QA/G-5S, December 2002, Guidance for Choosing a Sampling Design for Environmental Data
Collection. This document provides guidance on applying standard statistical sampling designs (such
as simple random sampling) and ore advanced sampling designs (such as ranked set sampling and
adaptive cluster sampling) to environmental applications.
EPA QA/G-5M, December 2002, Guidance for Quality Assurance Project Plans for Modeling. QA/G-
5M provides guidance for developing QA Project Plans that address the unique needs of modeling
projects.
EPA QA/G-6, April 2007, Guidance for Preparing Standard Operating Procedures. 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 (with Reissue Notice May 2006), Guidance on Technical Audits and
Related 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-8, November 2002 (with Reissue Notice January 2008), Guidance on Environmental Data
Verification and Data Validation. This document provides guidance to help organizations conduct
data verification and data validation activities.
EPA QA/G-9R, February 2006, Data Quality Assessment: A Reviewers Guide. QA/G-9-R provides
general guidance to organizations on assessing data quality criteria and performance specifications
for decision making. This is a non-technical document and shows a reviewer what constitutes an
appropriate Data Quality Assessment (DQA), and how to recognize situations or reports where a
DQA has been conducted.
EPA QA/G-9S, February 2006, Data Quality Assessment: Statistical Tools for Practitioners. This is
the technical version of QA/G-9R. It is designed as a 'toolbox' of useful techniques in assessing the
quality of data. The document is intended to enable the analyst to investigate many different
problems using systematic methodology.
EPA QA/G-10, December 2000 (with Reissue Notice May 2006), Guidance for Developing a Training
Program for Quality Systems. QA/G-10 provides guidance to help organizations determine and
develop program-specific quality system training for all levels of management and staff.
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References February 2009
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EPA QA/G-11, January 2005, Guidance on Quality Assurance for Environmental Technology Design,
Construction, and Operation. This document provides guidance on basic QA and QC principles and
good engineering principles and practices that may be used in the design, construction, or operation
of environmental technologies.
EPA QA/CS-1, February 2006, Systematic Planning: A Case Study for Hazardous Waste Site
Investigations. This document uses a case study to illustrate the use of systematic planning using
the Data Quality Objectives process. (It replaces an older document that was identified as QA/G-
4HW).
EPA QA/CS-2, March 2007, Systematic Planning: A Case Study of Particulate Matter Ambient Air
Monitoring. This document uses a case study to illustrate how the DQO process was applied to a
particulate matter ambient air monitoring program.
EPA/240/R-02/003, November 2002, Overview of the EPA Quality System for Environmental Data
and Technology. This guidance provides general information about existing EPA policies,
responsibilities, and resources to use in implementing both the EPA Quality System and quality
systems for specific organizations.
Other Reference Materials
Guidelines for Incorporating Quality Assurance into Procurement and Management of Office of Water
Technical Support Contracts, November 2008. This document is available on the OW intranet.
Guidelines for Internal Assessment of Office of Water Quality System Implementation, November
2008. Available on the OW intranet.
Peer Review Policy (and memo signed by the Administrator on January 31, 2006) (PDF) (4 pp, 261K)
and 3rd Edition of the Handbook (PDF) (190 pp, 1.15MB), available at
http://www.epa.gov/peerreview/
EPA/260R-02-008, October 2002, Guidelines for Ensuring and Maximizing the Quality, Objectivity,
Utility, and Integrity, of Information Disseminated by the Environmental Protection Agency. These
information quality guidelines (IQGs) were developed in response to guidelines issued by the Office
of Management and Budget (OMB) under Section 515 of the "Treasury and General Government
Appropriations Act for FY2001. This document is available electronically at
http://www.epa.qov/QUALITY/informationquidelines/
Office of Water Information Quality Guidelines: Pre-Dissemination Review Guidance and Checklists,
version 2.2 (January 10, 2003). Available on the EPA intranet at
http://intranet.epa.gov/ow/informationresources/qualitv/qualitvmanage.html.
Note 1: Page 1 (Background section) of this OW document provide the incorrect web site reference
for EPA's information quality guidelines guidance. The correct website link is:
http://www.epa.qov/QUALITY/informationquidelines/
Note 2: This OW document includes the following checklists
> Office of Water Information Quality Guidelines Checklist for Influential Information
> Office of Water Information Quality Guidelines Checklist for Influential Risk Assessment
Information
> Office of Water Information Quality Guidelines Checklist for Non-Influential Information
Information Access Policy (CIO 2171.0, 1/24/2008), Information Access Procedures (CIO 2171-P-01,
1/24/2008) and Customer Service and Public Access Standards (CIO 2171-S-01, 1/24/2008) issued by
the EPA Chief Information Officer as CIO Transmittal No. 08-006.
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Office of Water Quality Management Plan Revision No. 3
February 2009
Attachment A
Generic Quality Assurance Project Plan Checklist
The checklist that follows is an example of an approach that can be used to evaluate quality assurance
project plans developed by EPA or external organizations. It outlines 24 elements of a quality assurance
project plan and asks questions about how the plan addresses various aspects of each element.
Under the graded approach to quality management described throughout this document, this checklist
may be used as is, noting that aspects and elements that do not apply to a given environmental data
collection project, or the checklist may be modified for project-specific needs. As noted in Chapter 5 of
the Office of Water QMP, other forms of documentation may be employed, provided that the information
needed to meet the requirements of the Office of Water quality system is included.
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Attachment A February 2009
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Generic Quality Assurance Project Plan Checklist
December 2007
Project Title: Reviewer:
EPA Project Manager: Submitted:
Plan Author/Organization: Date Reviewed:
Conclusion/Recommendation:
Acceptable Acceptable with minor revisions Not
For plans found to be not acceptable, major deficiencies (defined here as the of relevant
information) were found in the following elements:
Title & Approval Sheet Analytical Methods
Table of Contents Quality Control
Distribution List Instrument/Equipment Testing
Project/Task Organization Instrument Calibration & Frequency
Problem Definition/Background Inspection/Acceptance for Supplies
Project/Task Description Data Acquisition (Non-Direct)
Quality Objectives & Criteria Data Management
Special Training/Certification Assessments & Response Actions
Documentation & Records Reports to Management
Sampling Process Design Data Review, Validation, & Verification
Sampling Method Validation and Verification Methods
Sample Handling & Custody Reconciliation with User Requirements
See the attached for comments related to all elements.
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A = Acceptable Nl = Not Included
U = Unacceptable NA = Not Applicable
A1 . Title & Approval Sheet
Title
Organization's name
Dated signature of project manager
Dated signature of QA officer
Other signatures, as needed
A2. Table of Contents
A3. Distribution List
A4. Project/Task Organization
Identifies key individuals with their responsibilities
(e.g., data users, decision makers, project QA
manager, Subcontractors)
Organization chart shows lines of authority &
reporting responsibilities
AS. Problem Definition/Background
Clearly states problem or decision to be resolved
Historical & background information
A6. Project/Task Description
Lists measurements to be made
Cites applicable technical, regulatory, or program-
specific quality standards, criteria, or objectives
Notes special personnel or equipment requirements
Provides work schedule
Notes required project & QA records/reports
A7. Quality Objectives & Criteria for
Measurement Data
States project objectives and limits, both qualitatively
& quantitatively
States & characterizes measurement quality
objectives as to applicable action levels or criteria
A8. Special Training
Requirements/Certifications
A9. Documentation & Records
Lists information & records to be included in data
report (e.g. raw data, field logs, results of QC
checks, problems encountered)
States requested lab turnaround time
Gives retention time and location for records and
reports
A
U
Nl
NA
Comments
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A = Acceptable Nl = Not Included
U = Unacceptable NA = Not Applicable
B1. Sampling Process Design (Experimental
Design)
Types and number of samples required
Sampling network design & rationale for design
Sampling locations & frequency of sampling
Sample matrices
Classification of each measurement parameter as
either critical or needed for information only
Validation study information, for non-standard
situations
B2. Sampling Method Requirements
Identifies sample collection procedures & methods
Lists equipment needs
Identifies support facilities
Identifies individuals responsible for corrective action
B3. Sample Handling & Custody Requirements
Notes sample handling requirements
Notes chain of custody procedures, if required
B4. Analytical Methods Requirements
Identifies analytical methods to be followed (with all
options) & required equipment
Provides validation information for non-standard
methods
Identifies individuals responsible for corrective action
B5. Quality Control Requirements
Identifies QC procedures & frequency for each
sampling, analysis, or measurement technique, as
well as associated acceptance criteria and
corrective action
References procedures used to calculate QC
statistics (e.g., precision, bias, accuracy)
B6. Instrument/Equipment Testing, Inspection,
and Maintenance Requirements
Identifies acceptance testing of sampling and
measurement systems
Describes equipment needing calibration and
frequency for such calibration
Notes availability & location of spare parts
A
U
Nl
NA
Comments
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A = Acceptable Nl = Not Included
U = Unacceptable NA = Not Applicable
B7. Instrument Calibration & Frequency
Identifies equipment needing calibration and
frequency for such calibration
Notes required calibration standards and/or
equipment
Cites calibration records & manner traceable to
equipment
B8. Inspection/Acceptance Requirements for
Supplies & Consumables
States acceptance criteria for supplies &
consumables
Notes responsible individuals
B9. Data Acquisition Requirements for Non-
Direct Measurements
Identifies type of data needed from non-
measurement sources (e.g., computer data bases
and literature files), along with acceptance criteria for
their use
Describes any limitations of such data
B10. Data Management
Describes standard record keeping & data storage
and retrieval requirements
Checklist or standard forms attached to QAPP
Describes data handling equipment & procedures
used to process, compile and analyze data ( e.g.,
required computer hardware & software)
A
U
Nl
NA
Comments
A = Acceptable Nl = Not Included
U = Unacceptable NA = Not Applicable
C1 . Assessments & Response Actions
Lists required number, frequency, &type of
assessments, with approximate date & names of
responsible personnel
Identifies individuals responsible for corrective actions
C2. Reports to Management
Identifies the preparer and recipients of reports
Identifies frequency and distribution of reports for:
Project status
Results of performance evaluations & assessments
Results of periodic data quality assessments
Any significant QA problems
A
U
Nl
NA
Comments
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A = Acceptable Nl = Not Included
U = Unacceptable NA = Not Applicable
D1 . Data Review, Validation, & Verification
States criteria for accepting, rejecting, or qualifying
data
Includes project-specific calculations or algorithms
D2. Validation and Verification Methods
Describes process for data validation and verification
Identifies issue resolution procedure and responsible
individuals
Identifies method for conveying these results to data
users
D3. Reconciliation with User Requirements
Describes process for reconciling with DQOs and
reporting limitations on use of data
A
U
Nl
NA
Comments
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Attachment B
Appendices from EPA's Contracts Management Manual Chapter 46
(Appendices 46.1 A, 46.1B, and 46.1C)
The following pages contain Directions for Contraction Officers Representatives, Directions for
Contracting Officers, and Contracts Clause and Tailoring Language from EPA's Contracts Management
Manual (CMM), Chapter 46 Appendices 46.1 A, 46.1B, and 46.1C, respectively.
The Office of Water QMP Appendix B header has been added to each page, but to avoid confusion,
these documents have not been renumbered for the purposes of this quality management plan, since
they are the products of the Office of Acquisitions Management and are not subject to modification by the
Office of Water. The titles and footers of each document appear here as published in the CMM
appendices.
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Attachment B February 2009
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Contracts Management Manual April 7, 2004
APPENDIX 46.1A DIRECTIONS FOR
CONTRACTING OFFICER'S REPRESENTATIVES
Before Award of Contract
STEP 1. Review the Statement of Work with the QA Manager (or the appropriate QA Personnel1) to
determine if QA requirements apply. If not, complete Sections I, Ma, and IV of the QA Review
Form (Appendix 46.1 D or an approved program-specific form provided by your QA Manager),
and the remaining steps (before award of contract) do not apply.
STEP 2. If QA requirements apply, determine what standards apply as allowed by your organization's
Quality Management Plan (with the assistance of the QA Manager). Generally, ANSI/ASQC
E4-1994 applies to the majority of EPA's work requiring higher-level contract quality
requirements; however, standards other than ANSI/ASQC E4-1994 may apply depending on
the nature of the work (for example, ISO 9001, ANSI/ASME NQA-1, etc.). If standards other
than ANSI/ASQC E4-1994 apply, identify (with the assistance of the QA Manager) what
documentation is required to determine conformance to these standards.
STEP 3. Complete the QA Review Form (Appendix 46.1 D or an approved program-specific form
provided by your QA Manager) and obtain a concurrence signature of the QA Manager as
part of the acquisition package. For each type of documentation selected in Section lll.b of
the QA Review Form, identify (with the assistance of the QA Manager) whether the
documentation should be prepared in accordance with the standard EPA requirements [i.e.,
EPA Requirements for Quality Management Plans (QA/R-2) and EPA Requirements for
Quality Assurance Project Plans (QA/R-5)] or whether other EPA-approved requirements will
be used. The standard EPA requirements should be used unless the QA Manager agrees to
different requirements identified in your organization's approved Quality Management Plan.
STEP 4. If the potential value of the procurement exceeds $500,000; or the estimate of the percentage
of costs or level-of-effort allocated to activities requiring quality requirements exceeds 15%;
or procedures defined in the Agency-approved Quality Management Plan of the organization
sponsoring the work apply; then the quality documentation (i.e., the Quality Management
Plan or equivalent documentation)
Appropriate QA personnel are defined in each EPA organization's Agency-approved Quality
Management Plan. For simplicity, the use of the term QA Manager will refer to both the QA Manager and
other approved QA personnel.
Contracts Management Manual Section 46.1 Page 5
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Contracts Management Manual April 7, 2004
shall be included as part of the Technical Evaluation Criteria. The QA Manager, QA Officer,
or authorized QA designee as defined in the organization's approved Quality Management
Plan, shall: (1) assist the Project Officer with development of the Technical Evaluation
Criteria, and any associated technical instructions, for the Request for Proposal, and (2)
serve as a member of the Technical Evaluation Panel for the purpose of evaluating the QA
aspects of the technical proposals when a Technical Evaluation Panel is convened.
After Award of Contract - Perform these steps for each Statement of Work under the contract.
STEP 5. Review the project and determine if it requires quality documentation (for example, a QA
Project Plan). Incorporate the requirement to develop this documentation and to implement
the EPA-approved documentation into the project's Statement of Work. If the project will be
based on previously prepared and current EPA-approved quality documentation , incorporate
the requirement to implement this documentation into the project's Statement of Work.
STEP 6. Complete a QA Review Form (Appendix 46.1 D or an approved program-specific form
provided by your QA Manager) for each project and attach it to the project's Statement of
Work (e.g., work assignment, delivery order, task order). Obtain a concurrence signature of
the QA Manager.
2For policy on approval procedures and requirements for ensuring quality documentation is current, see
Sections 5.2.1 and 5.2.2 of EPA Manual 5360 A1 (May 2000) and your organization's Quality
Management Plan.
Contracts Management Manual Section 46.1 Page 6
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Attachment B February 2009
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Contracts Management Manual April 7, 2004
APPENDIX 46.1 B DIRECTIONS FOR CONTRACTING OFFICERS
STEP 1: Review the QA Review Form (Appendix 46.1 D) provided by the COR. If the COR has not
provided a QA Review Form ask him/her to provide such form.
STEP 2: If the procurement requires higher-level quality assurance requirements, insert the contract
clause in Appendix 46.1C into the simplified acquisition, solicitation, and/or contract, and
select the appropriate documentation using Section lll.b of the QA Review Form provided by
the COR. If standards other than ANSI/ASQC E4-1994 are identified by the COR in Section
III.a.2 of the QA Review Form, insert these standards (and any tailoring) into the contract
clause in Appendix 46.1C. Also, incorporate the following statement addressing the
requirements for conforming to these standards:
"The following quality requirements apply to this work:" "
STEP 3: Incorporate all approved QA documentation submitted by the contractor before award into the
contract. Note: EPA may require that the Contractor revise the quality documentation after
award of the contract, so verify with the COR that the documentation has been approved
before incorporating it into the contract.
STEP 4: After award of the contract, review the QA Review Form and any quality assurance
requirements and information provided by the COR for each Statement of Work performed
under the contract. Ensure that these requirements are consistent with the quality
requirements of the contract.
Contracts Management Manual Section 46.1 Page 7
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Contracts Management Manual April 7, 2004
APPENDIX 46.1 C CONTRACTS CLAUSE AND TAILORING LANGUAGE
Do not incorporate the instructions in brackets [] into the solicitation and contract.
Higher-Level Contract Quality Requirement (FAR 52.246-11) (Feb 1999).
[Contracting Officer (CO), incorporate the following language into all solicitations and contracts that
require higher-level quality standards using the QA Review Form provided by the Contracting Officer's
Representative (COR). Include any other quality standards identified by the COR on the QA Review
Form.]
The Contractor shall comply with the higher-level quality standard selected below.
0
r
r
Title
Specifications and Guidelines for
Quality Systems for Environmental
Data Collection and Environmental
Technology Programs
Numbering
ANSI/ASQC E4
Date
1994
Tailoring
See below.
As authorized by FAR 52.246-11, the higher-level quality standard ANSI/ASQC E4 is tailored as follows:
The solicitation and contract require the offeror/contractor to demonstrate conformance to
ANSI/ASQC E4 by submitting the quality documentation described below.
In addition, after award of the contract, the Contractor shall revise, when applicable, quality
documentation submitted before award to address specific comments provided by EPA and
submit the revised documentation to the Contracting Officer's Representative.
After award of the contract, the Contractor shall also implement all quality documentation
approved by the Government and specified under this contract.
A. [CO, select the appropriate documentation using information provided by the COR and then insert
the following into the solicitation and contract]
Contracts Management Manual
Section 46.1
PageS
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Contracts Management Manual April 7, 2004
Quality Documentation: The offerer must submit the following quality system documentation:
Before Award Documentation
1. Documentation of an organization's Quality System: Either QMP developed in
accordance with R2 or Other:
Combined documentation of an organization's Quality System and application of
QA and QC activities to the single project covered by the contract: Either
developed in accordance with R-2 and R-5 or Other:
2. Programmatic QA Project Plan. Either developed in accordance with R-5 or
Other:
Application of QA and QC activities to the single project covered by contract:
Either QA Project Plan developed in accordance with R-5 or
Other:
Not applicable.
After Award Documentation
3. Documentation of an organization's Quality System: Either QMP developed in
accordance with R2 or Other:
Combined documentation of an organization's Quality System and application of
QA and QC to the single project covered by the contract: Either developed in
accordance with R-2 and R-5 or Other:
Not applicable.
4. Documentation of the application of QA and QC activities to applicable project(s):
Either developed in accordance with R-5; A supplement to the following
programmatic QA Project Plan; or Other:
Programmatic QA Project Plan with supplements for each specific project:
Developed in accordance with:
Existing documentation of the application of QA and QC activities will be used:
Either Documentation developed pre-award; Documentation will be identified
in individual statements of work; or Documentation identified in Section of
the Statement of Work
B. [PRE-AWARD TAILORING LANGUAGE: CO, insert the following paragraph into the solicitation
and contract]
Contracts Management Manual Section 46.1 Page 9
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Pre-award Documentation: The offerer must submit the documentation identified above as
"Before Award" as a separate and identifiable part of its technical proposal. This documentation
will be prepared in accordance with the requirements identified above [R-2 refers to EPA
Requirements for Quality Management Plans (EPA/240/B-01/002); R-5 refers to EPA Requirements
for QA Project Plans (EPA/240/B-01/003)]. The offerer shall describe their plan for covering the
costs associated with the required documentation. Work involving environmental data generation
or use shall not commence until the Government has approved this documentation and
incorporated it into the contract.
C. [POST-A WARD TAIL ORING LANGUA GE: CO, insert the following three paragraphs into the
solicitation and contract]
Post-award Documentation: The Contractor shall submit the quality system documentation
identified above as "After Award" to the Contracting Officer's Representative following issuance of
applicable statements of work.
This documentation will be prepared in accordance with the requirements identified above [R-2
refers to EPA Requirements for Quality Management Plans (EPA/240/B-01/002);
R-5 refers to EPA Requirements for QA Project Plans (EPA/240/B-01/003)]. The offerer shall
describe their plan for covering the costs associated with the required documentation.
The Government will review and return the quality documentation, with comments, and indicate
approval or disapproval. If the quality documentation is not approved, the contractor shall revise the
documentation to address all comments and shall submit the revised documentation to the
government for approval.
The Contractor shall not commence work involving environmental data collection, generation, use
or reporting until the Government has approved the quality documentation.
Contracts Management Manual Section 46.1 Page 10
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Attachment C
Quality Assurance Review for Extramural Projects
(Contracts)
The following pages contain a two-page example of the quality assurance review form that use used in
the acquisition of new contracts. This form is part of the Procurement Initiation Notification, or PIN,
package. A copy of the latest available version of this form may be obtained from your QA Officer or QA
Coordinator or may be downloaded from the Office of Water intranet.
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Attachment C February 2009
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Quality Assurance Review for Extramural Projects
(Contracts)
I. GENERAL INFORMATION
Descriptive Title:
Sponsoring Program Office:
Approximate Dollar Value:
Duration:
II. This contract requires environmental measurements
(YES) Complete form
(NO) sign form and submit with procurement request or procurement initiation
notice.
III. Quality Assurance Requirements (Projects involving environmental measurements):
YES NO
a. Submission of a written quality assurance (QA) program plan (commitment of the
offerer's management to meet the QA requirements of the scope of work) is to be
included in the contract proposal.
YES NO
b. Submission of a written QA project plan is to be included in the contract proposal.
YES NO
c. A written QA project plan is required as a part of the contract.
YES NO
d. Performance on available assessment samples or devices shall be required as part
of the evaluation criteria (see list on the next page).
YES NO
e. An on-site evaluation of the offerer's facilities will be made to ensure that a QA
system is operational and exhibits the capability for successful completion of this
project (see schedule on the next page).
YES NO
f. QA reports will be required (see schedule on the next page).
IV. Determination (Projects involving environmental measurements)
Percentage of technical evaluation points assigned to QA
PO estimate of percentage of cost allocated to environmental measures
For each parameter measured attach a summary which provides the following information:
a. Is quality control reference sampling or device available?
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Attachment C February 2009
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b. Are there split samples for cross-comparison?
c. Is it required for pre-award?
d. Specify frequency during the contract.
QA System Assessments are required: Pre-award ; during the contract.
QA Reports are required: with Progress Reports ; with the Final Report.
The signatures below verify that the QA requirements have been established.
Project Officer Signature Date
Quality Assurance Officer Signature Date
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Attachment D
Quality Assurance Review for Extramural Projects
(Contracts, WAs, DOs, and TOs)
The following pages contain an example of the two-page quality assurance review form that use used
during the implementation of Office of Water contracts. This form is used when issuing Work
Assignments, Delivery Orders, and Task Orders. A copy of the latest available version of this form may
be obtained from your QA Officer or QA Coordinator or may be downloaded from the Office of Water
intranet.
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Office of Water Quality Management Plan
Attachment D
Revision No. 3
February 2009
Page D-1
ATTACHMENT D
QUALITY ASSURANCE REVIEW FORM FOR EXTRAMURAL PROJECTS
(CONTRACT WAs, DOs, and TOs)
PART 1CONTRACT INFORMATION
I. Contract #
WA/DO/TO #:
Contractor Name:
Descriptive Title:
Original WA/
DO/TO:
WA/DO/TO
Amendment:
Carryover
WA/DO/TO:
WA/DO/TO Duration:
PART 2QUALITY ASSURANCE
II. This WA/DO/TO requires environmental measurements: (For each
parameter measured summarize the QA/QC requirements in the WA/DO/TO.)
YES % of effort: NO
III. This WA/DO/TO requires use of data from other sources;
YES % of effort: NO
IV. This WA/DO/TO requires use of models and/or databases:
YES % of effort: NO
If any are yes, complete sections V and VI, otherwise skip to Part 3 and Part 4.
Note: All work funded by EPA
that involves the acquisition of
environmental data generated
from direct measurement
activities, collected from other
sources, or compiled from
computerized data bases and
information systems shall be
implemented in accordance
with an approved QA Project
Plan.
V. Quality Assurance Requirements (Projects involving environmental measurements, use of secondary data, or
models/data bases): Check ail that apply. Add requirements as needed.
NOTE: Contractor does not receive this form- all QA requirements MUST be written into the WA/DO/TO.
A.
B.
C.
D.
E.
F.
G.
H.
Approved contract/ generic QAPP is applicable. (Attach copy. Also check additional needs below.)
A complete written QA project plan is required as a part of the WA/DO/TO. (Note: if Sec. II, III, or IV are
ves. Sec. V.A is not applicable and this is an original WA. check this box.)
The QAPP for the original WA/DO/TO applies. (For carry over WA/DO/TOs and some WA/DO/TO
amendments only).
Additional written QAPP descriptive elements required as a part of the WA/DO/TO. (If:
(1) contract/generic QAPP is not sufficient to address all of the WA/DO/TOs QA/QC requirements, or
(2) original WA/DO/TO QAPP is not sufficient to address all of the amendment QA/QC requirements.)
An on-site evaluation of the offerer's facilities will be made to ensure that a QA system is operational
and exhibits the capability for successful completion of this project.
Periodic QA audits are required in the WA/DO/TO. (complete Section VLB and/or VI. C)
QA reports are required in the WA/DO/TO. (complete Section VI. A)
Other (Specify in the Comments section, below)
VI. QA Documentation:
A.
B.
QA Reports are required (check all that apply)
D With Progress Reports D With Final Report
D Annually D Other
QA Performance Audits are required (check all that apply) If required during WA/DO/TO, specify frequency
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Office of Water Quality Management Plan
Attachment D
Revision No. 3
February 2009
Page D-2
c.
D Before WP Approval (or equivalent)
D During the WA/DO/TO
QA System Audits are required (check all that apply)
D Before WP Approval (or equivalent)
D During the WA/DO/TO
during WA/DO/TO:
If required during WA/DO/TO, specify frequency
during WA/DO/TO:
PART 3INFORMATION QUALITY GUIDELINES
VII. Does this WA/DO/TO involve a product that will be disseminated to
the public under EPA's Information Quality Guidelines? (See the Office of
Water Information Quality Guidelines: Pre-Dissenn'nation Review Guidance and
Checklists)
YES
NO
If yes, who will prepare the Information Quality Guidelines Checklist? (If this is the contractor, it must be
specified in the WA/DO/TO.)
The Product will be:
(check one)
D Influential D Influential Risk D Non-influential
Information assessment Information Information
PART 4PEER REVIEW
VIII.
Does
this
WA/DO/TO
involve
a
scientific
or technical
work
product?
YES
NO
If yes, attach a completed Peer Review Checklist for Determining Whether a Work Product Needs Peer
Review. (See the Peer Review Handbook.)
COMMENTS
APPROVALS
Name
WA/DO/TO Manager:
Branch Chief:
QA Coordinator :
Signature
Date
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Office of Water Quality Management Plan Revision No. 3
February 2009
Attachment E
Cincinnati Procurement Operations Division Work Assignment Review Checklist
The following page contains an example of the work assignment review checklist from the EPA Cincinnati
Procurement Operations Division. A copy of the checklist (or any subsequently issued version of this
checklist) is available from the Project Officer responsible for the contract under which the work
assignment will be issued.
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Office of Water Quality Management Plan Revision No. 3
Attachment E February 2009
Page E-1
Attachment E
Cincinnati Procurement Operations Division Work Assignment Review Checklist
December 2007
1. Contract number: 2. WA number:
3. Independent government estimate (attach completed form)
4, WA title:
5. Does WA/WA amendment fall within scope of work of this contract? D Yes D No
Cite specific section and paragraph(s) of contract SOW:
6. To the best of your knowledge, will the work to be performed under this WA duplicate any work
previously performed or currently being performed under any EPA contract? D Yes D No
7. (a) Total LOE ordered to date (not including this current WA/WA Amendment):
(b) Total LOE authorized to date under current term:
(c) Does this WAAA/A amendment require the exercising of quantity options? D Yes D No
(If so, attached justification)
8. (a) Are funds obligated in contract to support this WA? D Yes D No
(b) Is funding PR attached to support this WA? D Yes D No
(c) Is WA funded by multiple appropriations? D Yes D No
(d) If multiple appropriations, can accounts be identified with specific tasks?
(if not, attach FMD approval for use multiple appropriations) D Yes D No
9. Will all work (including deliverables) be completed during the current term? D Yes D No
10. Has the contractor been instructed to begin work on this WA,
prior to CO approval of WA, by anyone in the organization? D Yes D No
11. Does the WA contemplate improvement to realty
(repairs, alterations, modifications to real property)? D Yes D No
12. Does WA require printing or duplication exceeding contract limitations? D Yes D No
13. Does WA require videotaping or graphics support? D Yes D No
14. Does WA contemplate development or maintenance of software,
purchase of ADP equipment or ADP support services? Estimated Cost?
(If yes, attach OEI approval if not obtained at award) D Yes D No
15. (a) Has program recommended subcontracting/consulting
services to meet WA requirements? D Yes D No
(b) Has contractor been directed to use a particular source? D Yes D No
16. Does this WA include any actual or potential conflict of interest? D Yes D No
17. (a) Does WA contemplate personal services? D Yes D No
(b) Does WA contemplate inherently government functions? D Yes D No
(c) Does WA contemplate advisory and assistance services?
(If yes, attach copy of approval or indicate that this was obtained at contract award) D Yes D No
18. Does the WAAA/A amendment require the contractor to purchase or lease
(for more than two months) accountable property? D Yes D No
19. Is EPA Form 1900-65, designation and appointment of Project Officer/Work
Assignment Manager/Delivery Order Officer, completed and attached? D Yes D No
20. Is CBI checklist attached? D Yes D No
21. Is quality assurance project plan required from contractor? D Yes D No
Request/WAM signature (Date) Project Officer signature (Date)
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