QUALITY MANAGEMENT PLAN
FOR
EPA REGION III
DOCUMENT CONTROL NUMBER
RQMP/96-001
U.S. Environmental Protection Agency
Region III
841 Chestnut Building
Philadelphia, PA 19107
SEPTEMBER, 1996
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Region III Quality Management Plan September, 1996
Table of Contents Page T-1
TABLE OF CONTENTS
Title Page
Approval Memorandum
TABLE OF CONTENTS
Identification Form
Concurrences and Approvals
CHAPTER 1 ORGANIZATION AND MANAGEMENT
1.1 REGIONAL QA POLICY
1.2 SCOPE OF THE PLAN
1.3 ORGANIZATIONAL STRUCTURE
1.4 ROLES AND RESPONSIBILITIES
1.5 COMMUNICATIONS
CHAPTER 2 REGION Ill's QUALITY SYSTEM
2.1 PRINCIPAL COMPONENTS OF THE SYSTEM
2.2 PRINCIPAL TOOLS AND PRACTICES
CHAPTER 3 PERSONNEL QUALIFICATIONS AND TRAINING
CHAPTER 4 PROCUREMENT OF ITEMS AND SERVICES
4.1 CONTRACTS
4.2 SMALL PURCHASES
4.3 GRANTS AND COOPERATIVE AGREEMENTS
4.4 INTERAGENCY AGREEMENTS
CHAPTER 5 DOCUMENTATION AND RECORDS MANAGEMENT
CHAPTER 6 USE OF COMPUTER HARDWARE AND SOFTWARE
6.1 COMPUTER HARDWARE/SOFTWARE REQUIREMENTS
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Region III Quality Management Plan September, 1996
Table of Contents Page 7-2
6.2 SYSTEM DEVELOPMENT
6.3 DATA STANDARDS
6.4 INFORMATION SECURITY
CHAPTER 7 QA PLANNING
7.1 REGIONWIDE PLANNING
7.2 PROGRAM-SPECIFIC PLANNING
7.3 PROJECT-LEVEL PLANNING
CHAPTER 8 IMPLEMENTING QA PROCEDURES
8.1 REGIONWIDE IMPLEMENTATION
8.2 PROGRAM LEVEL IMPLEMENTATION
8.3 PROJECT LEVEL IMPLEMENTATION'
8.4 IMPLEMENTATION SCHEDULE
CHAPTER 9 QA ASSESSMENT AND RESPONSE
9.1 ANNUAL REVIEW OF REGIONAL QMP
9.2 REGIONAL AUDITS
9,3 PERFORMANCE EVALUATIONS
9.4 DATA QUALITY ASSESSMENTS
CHAPTER 10 CONTINUOUS IMPROVEMENT
10.1 APPROACH TO IMPROVEMENT
10.2 IMPROVEMENT LEADERS
10.3 QUALITY ASSURANCE COUNCIL
REFERENCES
APPENDICES
A. Terms and Definitions
B. EPA Order 5360.1
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Region III Quality Management Plan September, 1996
Identification Form Page 1-1
IDENTIFICATION FORM
Document Title: Region III Quality Management Plan
Document Control Number: RQMP - 96/001
Organizational Title: EPA Region III
Address: 841 Chestnut Building
Philadelphia, PA 19107
Responsible Official: W. Michael McCabe, Regional Administrator
Telephone: 215/566-2900
Regional Quality Assurance Manager: Diann Sims, QA Team Leader
Telephone: 410/573-2647
Plan Coverage: This Quality Management Plan (QMP) has been developed to
address the Agency quality assurance (QA) requirements and guidelines, and for the
data quality needs of Region III. The Plan reflects the overall QA Program framework
and management systems necessary to ensure that environmental data generated by
or for Region III are of acceptable quality to meet the needs of users and decision-
makers. It also describes the delegation of QA responsibilities to the various Divisions
and Offices within the Region. Each Regional Division and Program Office is
responsible for developing and continuously improving their own QMP.
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REGION III QUALITY MANAGEMENT PLAN
Concurrences and Approvals
Concurrences:
Diann Sims
Region III Quality Assurance Manager Phone: 410/573-2647
Signature: : Date:
John R. Pomponio, Director
Environmental Assessment and Protection Division Phone: 215/566-2702
Signature: ' Date:
William T. Wisniewski, Assistant Regional Administrator
Office of Policy and Management Phone: 215/566-5150
Signature: Date:
Alvin R. Morris, Director
Water Protection Division Phone: 215/566-5701
Signature: Date:
Thomas C. Voltaggio, Director
Hazardous Waste Management Division Phone: 215/566-3125
Signature: Date:
Thomas J. Maslany, Director
Air, Radiation and Toxics Division Phone: 215/566-2050
Signature: Date:
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William J. Matuszeski, Director
Chesapeake Bay Program Office
Signature:
Concurrences (continued):
Marcia E. Mulkey, Regional Counsel
Office of Regional Counsel
Signature: ,
James W. Newsom, Acting Director
Office of External Affairs
Signature:
Approval for Implementation:
W. Michael McCabe, Regional Administrator
Office of the Regional Administrator
Signature:
Phone: 410/267-5700
Date:
Phone: 215/566-2668
Date:
Phone: 215/566-5152
Date:
Phone: 215/566-2900
Date:
Stanley L. Laskowski, Deputy Regional Administrator
Office of the Deputy Regional Administrator
Signature:
Phone: 215/566-2989
Date:
Approval for Agency:
Nancy W. Wentworth, Director
Quality Assurance Division
Phone: 202/260-5763
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Signature: Date:
Robert J. Huggett, Ph.D.
Assistant Administrator for Research and Development Phone:, 202/260-7676
Signature: Date:
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Region III Quality Management Plan September, 1996
Chapter 1 Organization and Management Page 1-1
CHAPTER 1 ORGANIZATION AND MANAGEMENT
1.1. REGIONAL QUALITY ASSURANCE POLICY
1.1.1 Background
Region III has maintained the fundamental elements of a quality assurance and
quality control program ever since the establishment of the Regional office in the early
1970's. Following issuance of EPA Order 5360.1 in 1984, the Region attempted to
more systematically implement quality assurance program requirements, and in 1987
issued its own Regional Order (No. 5360.50) entitled "Region III Quality Assurance
Program Policy and Responsibilities". Since then, the Regional Office has
implemented its QA responsibilities, through the lead of its Environmental Services
Division (now the Environmental Assessment and Protection Division), over an
increasingly complex set of environmental programs, monitoring activities, grants and
contracts.
1.1.2 Importance of QA/QC within the Region
Managers and staff at EPA Region III make daily decisions which affect the lives
and livelihoods of millions of people who reside in the Middle Atlantic states. The
quality of air, water and land on which these people depend is the focus of our mission.
The quality of decisions made by EPA and its state counterparts depends heavily on
the quality of the information used to make those decisions. Everything we do at EPA
starts with the environmental information we have at hand. While other factors such as
the law, public opinion, and Court direction also influence our decisions, nothing is
more fundamental to our daily decisions than environmental data. If that data is not of
adequate quality to support its intended uses, then the decisions suffer
commensurately.
Environmental data is used for setting priorities, strategic direction, targeting
inspections, measuring compliance, identifying enforcement actions, measuring
progress and trends, certifying laboratories and for many other uses. This data is often
critical because it can impact our programs' direction and emphases, determine
whether an enforcement case will be successful, dictate which of several possible
cleanup options will be implemented at a hazardous waste site, or demonstrate our
progress to the public and Congress.
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Region III Quality Management Plan September, 1996
Chapter 1 Organization and Management Page 1-2
The consequences of "poor" data (that which does not meet user requirements)
are that our individual and collective decisions are not as sound as they could and
should be. In the fortunate cases, the consequences of "poor" data can be relatively
minor. However, on many occasions, the effects can be significant, such as when an
enforcement case has to be withdrawn because our own underlying compliance data is
challenged successfully by defendants.
1.1.3 General Goals and Objectives of the Regional Quality System
Region Ill's Quality System is designed to avoid occasions where environmental
data collected falls short of meeting the quality requirements established by the users
of the data. The primary goal of this Quality System is to ensure that all
environmentally-related data collection and processing activities performed by or for
the Region will result in the production of data that are documented and of known
quality, and can be used with a high degree of certainty by the intended user to support
specific decisions or actions. This includes those monitoring and measurement
activities supported by EPA through grants, contracts or interagency agreements. This
goal will be achieved by ensuring that appropriate resources are made available and
proper procedures followed throughout the process of planning for, collecting,
analyzing and interpreting environmental data.
Specifically, it is the policy of Region III that:
o Each Regional program or activity that generates environmental data will be
part of an effective Quality Assurance (QA) program, and will document their
involvement in such program within the framework of a Program, Division or Office
Quality Management Plan (QMP).
o The objectives for generating any new environmental data will be determined
prior fcrdata collection activities, so that appropriate resources, and quality assurance
and control methods can be applied to ensure a level of data quality commensurate
with the intended use(s) for the data.
o Each program or activity that generates environmental data will develop and
implement a QA Project Plan (QAPP) and/or Standard Operating Procedures (SOPs)
which specifies the detailed procedures required to assure production of quality data.
These QAPP's shall be prepared by the originating program, and reviewed and
approved by an authorized QA representative prior to the start of any data collection
effort.
o All Regional programs that support externally generated environmental data
through contracts, grants or interagency agreements will ensure that acceptable QA
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Region III Quality Management Plan September, 1996
Chapter 1 Organization and Management ' Page 1-3
requirements are included in the appropriate agreement documents, and that these
external parties follow acceptable Quality Management practices as described in the
relevant Federal regulations, and in requirements and guidance issued by EPA's
Quality Assurance Division (QAD).
o Similarly, any Regional programs or activities that accept externally generated
environmental data for use in decision-making, shall ensure that the party supplying the
data has followed acceptable Quality Management practices.
o Quality assurance (QA) practices and quality control (QC) procedures will be
implemented in the most cost effective,manner possible without compromising data
quality objectives.
o There shall be an ongoing system of evaluation for Regional QA efforts to
ensure that the Quality System is meeting the needs and expectations of data users,
and QA requirements and guidelines set forth by EPA Headquarters.
1.1.4 Resources for the QA System
The resources necessary to conduct the various QA and QC activities within the
Region are provided by the program customers who require assistance in order to
successfully implement their programs. QA is viewed as an integral part of the
programs and activities to which QA applies, i.e., any program which deals with
environmental measurements and data generation. This includes all monitoring
activities. The level of QA resources needed for any given program or project is
determined initially by the relevant Regional program or project manager, based on
Headquarters' workload models and experience with similar QA efforts.
Most of the Region's QA related positions are located within the Environmental
Assessment & Protection Division. Of these, the majority are located within the Office
of Analytical Services and Quality Assurance (OASQA) in Annapolis, MD. Since there
exists no assigned national program element for Quality Assurance, most resources
needed for QA are taken from a variety of program elements which utilize the QA
functions and services of EAPD. Included in this mix are resources devoted to general
management of the Quality System which are contributed by all benefitting programs.
1.2 SCOPE OF THE QUALITY MANAGEMENT PLAN
The Agency's Quality Assurance policies require that all EPA organizations
(national program offices, regional offices, ORD laboratories, etc.) that conduct or
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Region III Quality Management Plan September, 1996
Chapter 1 Organization and Management Page 1-4
support environmentally-related measurements (as defined in EPA Order 5360.1) will
participate in the Agencywide QA program. This participation includes the preparation
of an organizational Quality Management Plan (in this case, a Regional QMP). This
Plan is intended to establish the foundation for implementing an effective QA program
within Region III, covering all intramural and extramural activities which involve the
generation of environmental data.
This Quality Management Plan applies to any and all Region III programs,
activities, grants, contracts and interagency agreements that generate environmental
data which is used to make decisions or support actions related to our defined mission
and responsibilities. Environmental data is defined as information or measurements
resulting from any field data collection activity, laboratory analyses or models involving
the assessment of chemical, physical or biological factors relating to the environment.
Therefore, any programs, activities, etc. which generate such data are required to
comply with the requirements of this QMP.
Since Region III employs a primarily decentralized approach to quality
management, each Division or Program Office is responsible for determining the
specific environmental programs and activities to which the quality system will apply.
However, following is a sampling of the types of environmental programs, grants and
activities within each Division and Office which are covered by the Region III Quality
System.
Water Protection Division
Safe Drinking Water Act
Public Water System Supervision Program
Sole Source Aquifer Program
Comprehensive State Ground Water Protection Program
Underground Injection Control Program
' Wellhead Protection Program
Clean Water Act
National Pollutant Discharge Elimination System (NPDES) Program
Water Quality Management (Section 106) Grants Program
Watershed Protection Program
Nonpoint Source (Section 319) Grants Program
Volunteer Monitoring Program
Clean Lakes Program
State Revolving Fund Program
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Region III Quality Management Plan September, 1996
Chapter 1 Organization and Management Page 1-5
Water Quality Standards Program
Watershed Grants Program (Section 104(b)(3))
Air. Radiation and Toxics Division
Clean Air Act
Ambient Air Quality Data (monitoring by states via 105 grants)
Emissions Inventory Data (by states as per 40 CFR Part 51)
Stack Testing (by company, state or EPA)
I/M Program statistics (reports by states under 105 grants)
Asbestos NESHAP sampling
Other CAA Compliance Inspections
Toxics, Pestjcides and Radon Data
PCB Sampling
Pesticide Program (FIFRA)
Radon measurements in homes (for conditions and trends analyses)
Surface coating sampling (compliance monitoring)
Lead (Pb) Program grants (TSCA Title IV, Section 404(g))
Environmental Assessment & Protection Division
Laboratory Analyses - performed at Annapolis and Wheeling labs
Ambient air monitoring - per 40 CFR Part 58
Ambient water monitoring (routine monitoring performed mostly through the
states);
Compliance inspections which generate environmental data
State Laboratory Inspections
Ocean Dumping Program
National Estuary Program coastal waters sampling
Environmental Monitoring and Assessment Program (EMAP)
Mid-Atlantic Highlands Assessment Program (MAHA)
Community-Based Special Studies (e.g., Newton-Chester, Monroe County)
Fish Tissue Surveys
Hazardous Waste Management Division
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Region III Quality Management Plan September, 1996
Chapter 1 Organization and Management Page 1-6
Superfund Office
• CERCLA Program, as amended by SARA
• CWA Section 311 Oil and Spill Response Program
RCRA Office
• RCRA Corrective Action Program
-Administrative Orders
-Permits .
• RCRA Enforcement Program - Compliance Monitoring
« Delegated activities through RCRA grants to States
• Underground Storage Tank Program
Chesapeake Bay Program Office
• Mainstem and Tributary Monitoring Program
• Fall Line Monitoring Program
• Ambient Toxicity Monitoring Program
• Atmospheric Deposition Program
1.3 REGION III ORGANIZATIONAL STRUCTURE
Region III employs a decentralized approach to QA management, whereby eacn
Division, Office or program is responsible for deciding how they will specifically
implement the general policies and procedures of this QMP. The Regional
Administrator has delegated major responsibility for overseeing the QA System to the
Environmental Assessment and Protection Division (EAPD).
Within EAPD, a Quality Assurance Team (OAT) in Annapolis serves as
Regional QA Program lead, and the Team Leader as the Regional QA Manager
(RQAM). The RQAM, while located within the Division's Office of Analytical Services
and Quality Assurance, has direct access and reporting authority to the Division
Director. A Regional QA Officer (RQAO) located in the EAPD Philadelphia Office
serves as the senior technical QA expert for the Region and assists with a variety of
QA functions. Both the RQAM and the RQAO maintain an independence in location
and function from any offices or programs which generate environmental data.
The Region is composed of four major program Divisions - Water Protection, Air,
Radiation and Toxics, Hazardous Waste Management, and Environmental Assessment
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Region III Quality Management Plan September, 1996
Chapter 1 Organization and Management Page 1-7
and Protection - as well as the Offices of Policy & Management, External Affairs,
Regional Counsel and the Chesapeake Bay Program. Each Division and
Program Office assigns a Quality Assurance Coordinator (QAC) to work with the
RQAM to implement the QA Program. Figure 1-1 depicts the general Regional QA
organizational structure, while Figure 1-2 illustrates the location of the Regional QA
Manager within the EAPD.
It should be noted that all of the program Divisions and the Office of Policy &
Management have undergone major reorganizations during the past two years in
response to streamlining and reinventing government initiatives. As a result, in some
Divisions a layer of supervisory management has been eliminated. Thus, first line
supervisors, who are primarily responsible for ensuring that approved QAPPs and
QMPs are implemented, may be Section Chiefs in some organizations, while in others
they may be Branch Chiefs. Also, some former supervisors now serve in the capacity
of program managers, responsible for overseeing functional areas of work (e.g., the
Wetlands Program, the NPDES permits program). In this capacity, they may be
responsible for ensuring that QA requirements are met within their program's scope of
activities.
In addition to the above organizational structure, a Quality Assurance Council,
consisting of the QA Coordinators from each Division and Office, the RQAM, RQAO,
and a rotating management representative, will meet quarterly to discuss QA
implementation and common QA issues across the Region (see Section 1.5 of this
Chapter, and Chapter 10 for additional discussion about the Council).
1.4 ROLES AND RESPONSIBILITIES
Anyone in the Region who is directly or indirectly involved with environmental
data collection or analyses has some responsibility for ensuring data quality. This may
include staff level personnel, supervisors, project officers, program managers, senior
managers, and personnel specifically assigned to perform QA functions. The following
is an overview of the QA responsibilities of some of these Regional personnel:
Regional Administrator
The Regional Administrator (RA) has overall responsibility for the Regional QA
Program as described in EPA Order 5360.1, dated April 3, 1984. Specifically, the RA is
responsible for ensuring that QA is an identifiable activity with adequate resources
allocated for the accomplishment of program and Regional goals, including the
collection of the right type, quantity and quality of data for all in-house and extramural
projects.
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Region III Quality Management Plan September, 1996
Chapter 1 Organization and Management Page 1-10
Division and Office Directors (or Designated QA Coordinators)
(
Division and Program Office Directors have overall responsibility for managing
the QA program within their organization, as described in their own QMPs (QMPs are
not required for the Offices of Regional Counsel, External Affairs, and Policy &
Management). The Directors are specifically responsible for ensuring that:
• QMPs covering Divisional or Office QA operations are developed, updated and
effectively implemented;
• Adequate resources are provided to support QA program responsibilities;
• A QA Coordinator is designated to assist with QA implementation;
• All environmental data collection activities are covered by appropriate planning
documentation (DQOs, QAPP, SOP, QMP, etc.);
• QAPPs are written, signed, and effectively implemented for all projects which
generate environmental data;
• An adequate degree of auditing is performed to determine and achieve compliance
with QA requirements;
• Deficiencies highlighted in audits are corrected expeditiously;
• Program specific QA-related training needs are identified; and
• The Division/Office is represented on the Regional QA Council.
Regional Quality Assurance Manager (ROAM) and QA Team
• Maintain and update the Regional QMP;
• Oversee implementation of the Regional QMP;
• Prepare and submit the Annual QA Report and Workplan to Senior Regional
Managers and the QAD;
• Review and approve Region III Divisional, Office and State QMPs;
• Serve as primary Regional liaison with QAD in Headquarters and the State QA
contacts;
• Authorize individuals to review and approve QAPPs;
• Provide technical assistance to program offices and the states;
• Distribute Agency QA guidance documents, policies, and procedures;
• Routinely review the QA procedures within the Region and keep the RA and senior
managers apprised;
• Conduct formal reviews and assessments of QA and QC activities, and
prepare reports on such assessments;
• Provide guidance on QA issues for Regional use;
• Maintain a database/tracking system for Regional QA documents; and
• Assess Regional QA training needs, and arrange, develop and/or present training
courses on QA topics.
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Chapter 1 Organization and Management Page 1-11
Regional Quality Assurance Officer (RQAO)
Serve as senior technical QA expert within the Region;
Serve as secondary liaison with QAD in Headquarters and state QA contacts;
Assist the RQAM with assessment and provision of QA training needs;
Perform laboratory audits;
Review and certify drinking water laboratories;
Authorize individuals to review/approve QAPPs;
Provide technical assistance on program or project specific basis;
Administer the water supply and water pollution Performance Evaluation (PE)
studies; •
Administer the Air Program Performance Evaluation studies; and
Assist with audits of Regional and state QA programs to assure that they adhere to
their approved QMPs.
Program Managers
• Ensure that all intramural and extramural projects involving the generation of
environmental data are performed in accordance with the Regional and Divisional
QMPs and an approved QAPP;
• Ensure that resources needed to implement QA requirments are identified and
provided;
• Ensure that adequate procedures are in place to address QA requirments in all
applicable program operations, including those delegated to state agencies;
• Cooperate with any QA reviews or audits and submit requested information in a
timely manner;
• Take appropriate corrective action recommended by audit findings; and
• Discuss any QA concerns with the Divisional QA Coordinator and/or RQAM.
Project Officers and Work Assignment Managers
Project Officers (POs) and Work Assignment Managers (WAMs) are assigned
responsibility for specific projects supported by EPA through contracts, grants or
interagency agreements (lAGs). This catagory includes Superfund Remedial Program
Managers (RPMs) and On-Scene Coordinators (OSCs) who are responsible for site
specific monitoring projects. For those extramural projects which generate
environmentally related data, QA requirements must be followed. In addition to the
Regional and Divisional QMPs, the relevant QA requirements for extramural projects
are specified in 40 CFR 30 and 31, and 48 CFR 15. Chief among those requirements
are that any grant recipient or contractor conducting a project which involves
environmental measurements must have in place an acceptable Quality Management
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Region III Quality Management Plan September, 1996
Chapter 1 Organization and Management Page 1-12
System (as evidenced by a QMP or similar documentation), and must prepare an
acceptable Quality Assurance Project Plan (QAPP) prior to initiating any data
collection or analyses. In many cases, in order to document compliance with QA
requirements, a Quality Assurance Review Form (EPA Form 1900) must be completed,
and approved in writing by the relevant Project Officer and grants or contracts office
contact (see Chapter 4 for a description of specific procedures). Because POs and
WAMs may not be closely familiar with QA procedures, they are encouraged to work
with their Divisional QA Coordinator to ensure that QA requirements are addressed.
1.5 COMMUNICATIONS
To be effectively implemented, this QMP must not only be completed, circulated
and updated, but understood by those responsible for its implementation. Several
means will be used to ensure that this occurs. Lines of communication among some of
the involved and responsible QA personnel were described earlier in Section 1.3. The
Regional QA Manager will keep the EAPD Director and other senior managers
apprised of QA issues on a regular basis. The RQAM will also communicate and
coordinate with the Division and Office QA Coordinators regularly, and keep them
informed of new developments, policies, and other QA procedures, The QAM will also
maintain a list of all Region III state QA contacts and provide them with updates and
opportunities to exchange QA information as necessary.
The Region will also establish and maintain a standing Quality Assurance
Council consisting of the Division and Office QA Coordinators,,the Regional QAM and
QAO, and a rotating management representative. This group will meet on a quarterly
basis to discuss issues of data quality, QMP implementation, and any concerns or
suggestions for improving the Quality System. The Council is the primary cross-
Divisional Regional group for addressing Regionwide QA topics. The individual
Divisions and Offices will establish their own methods of communicating QA issues
within their respective organizations.
Finally, QA training will be offered on an ongoing basis in order that personnel
responsible for QA functions understand QA requirements and practices related to their
responsibilities. The RQAM will be responsible for ensuring that adequate training is
provided.
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Region III Quality Management Plan September, 1996
Chapter 2 Region Ill's Quality System Page 2-1
CHAPTER 2 REGION Ill's QUALITY SYSTEM
2.1 PRINCIPAL COMPONENTS OF THE SYSTEM
The Region III Quality Assurance System consists of the people, functions, tools
and procedures used to ensure that an appropriate quality of environmental data is
generated for the needs of Regional data users and decision makers.
A Regional Task Force which was established to produce this QMP identified
the following elements of an effective QA System:
o Statement of QA Goals and Policy
o List of Applicable QA Requirements and Criteria (EPA Orders, Regulations,
Guidelines, Federal Acquisition Regulations, etc.)
o Defined QA Organizational Structure
o Programs and Activities Covered by the QA Requirements
o Roles and Responsibilities of those involved with QA functions
o QA Tools and Procedures
o Resource Assessment and Accommodation
o Communications Processes (internal and external)
o Training Requirements
o Documentation and Record Keeping
o Review and Evaluation Procedures
o Definitions of Key QA Terms
o Methods for Continuous Improvement
As described in Chapter 1, overall QA Program responsibility is delegated to the
Environmental Assessment and Protection Division (EAPD). Within EAPD, a QA Team
(QAT) in Annapolis serves as Regional QA Program lead, and the Team Leader as the
Regional QA Manager (RQAM). A QA Officer (RQAO) located in Philadelphia serves
as the senior technical QA expert for the Region and assists with a variety of QA
functions.
The System is largely decentralized, with each Division and Office specifying QA
operating procedures in their own QMPs, consistent with this Regional QMP.
Divisional requirements many be more stringent than those presented in this QMP, but
not less stringent. Each Division and Program Office assigns a QA Coordinator to
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Region III Quality Management Plan. September, 1996
Chapter 2 Region Ill's Quality System Page 2-2
work with the RQAM and RQAO to support and implement the QA functions. A Quality
Assurance Council consisting of the Divisional QA Coordinators, the RQAM, RQAO,
and a Regional management representative(s), will meet quarterly to review the status
and needs of the Regional Quality System. By participating in this forum, each level of
the organization acknowledges and accepts responsibility for maintaining and
improving the Quality System.
2.2 PRINCIPAL TOOLS AND PRACTICES
Successful implementation of the Region III QA Program requires a consistent
and graded approach for QA practices, commensurate with the intended uses of the
data and degree of confidence needed in the results. A variety of tools and procedures
are employed for planning, implementing and evaluating the Quality System.
Managers and staff members are informed of the availability and use of these tools
through Regionwide training and through their Divisional Quality Assurance
Coordinators.
Primary QA planning and implementation tools include Quality Management
Plans (QMPs), establishment of Data Quality Objectives (DQOs), Quality Assurance
Project Plans (QAPPs), Standard Operating Procedures (SOPs) and, for Superfund,
Sampling and Assessment Plans (SAPs). Most of these tools are employed directly by
the Program Divisions/Offices, with technical assistance as necessary from the QA
Team, RQAM or RQAO.
Primary QA evaluation and assessment tools include Management Systems
Reviews (MSRs), Technical Systems Audits (TSAs), Performance Evaluations, and
Data Quality Assessments (DQAs). Most of these are arranged and/or performed by
the RQAM/QAT or RQAO.
Specific procedures for applying these tools are described in the Divisional
QMPs; however, some general requirements are specified in this Regional QMP,
including a requirement that all QAPPs must be approved, in writing, prior to
implementation.
2.2.1 Quality Management Plans
This Regional QMP describes the policies, procedures and systems governing
the Region III QA Program. It serves as the "umbrella" document for all Regional QA
operations. It was developed through the efforts of a cross-Divisional Regional Task
Force. Future revisions and updates to this QMP will be prepared by the Quality
Assurance Manager working through the Regional Quality Assurance Council.
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Chapter 2 Region Ill's Quality System Page 2-3
Each Region III Division and Program Office shall prepare a separate QMP that
describes their organization's QA management policies, objectives, and procedures.
These documents will be consistent with the requirements of the Regional QMP and
shall be prepared in accordance with EPA QA/R-2, as updated. Divisional
requirements may be more, but not less, stringent than those presented in this QMP.
The QAT/RQAM will review and approve Division and Program Office QMPs; prior to
their incorporation into the Regional QMP. All QMPs shall be reviewed and updated,
as necessary, on an annual basis.
QMPs submitted by state agencies and other external organizations as part of
extramural agreements will be submitted by the Divisional QA Coordinator to the
Regional QA Manager for review and approval. The QAM may request the Regional
QA Officer to assist with these reviews depending on the program involved. Approval
or disapproval of the QMP, along with any comments, will be returned to the submitter
within 15 working days.
2.2.2 Data Quality Objectives Process
Region III is committed to sound science and thus, the generation of
environmental data that are technically and legally defensible, and of adequate quality
to support decisions. The Data Quality Objectives (DQO) Process is used in the
planning phase of all environmental data collection activities. "Guidance for the Data
Quality Objectives Process, EPA QA/G-4" is used for the development of DQOs.
DQOs are a required element of any Quality Assurance Project Plan (QAPP) submitted
to Region III for review and approval. This requirement is applicable to all parties that
generate environmental data for use in Region III.
Each program office is responsible for establishing DQOs for its applicable
ongoing programs. The Quality Assurance Team will provide technical assistance as
warranted in determining the appropriateness of the DQO relative to the intended use
of the data. The Quality Assurance Team will review Divisional or Program QMPs to
.assure that Program offices establish and use DQOs. These.reviews will be performed
as part of the annual QMP review process by the appropriate QA Coordinator, with
assistance from the Regional Quality Assurance Manager (RQAM).
2.2.3 Quality Assurance Project Plans (QAPPs)
The QAPP presents the policies and procedures, organization, objectives,
quality assurance requirements, and quality control activities designed to achieve the
type and quality of environmental data necessary to support project objectives. In
Region III, no data collection or analyses will occur without the approval of the
supporting QAPP. All environmental data collection activities are subject to this
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Region III Quality Management Plan September, 1996
Chapter 2 Region Ill's Quality System Page 2-4
requirement. Additionally, all contracts must meet the Quality Assurance requirements
of the EPA Acquisition Regulations (EPAAR).
Region Ill's Quality Assurance Team is responsible for setting policy on format
and extent of detail necessary in each QAPP element. Each QAPP must use a
document control format that provides its version number and effective date. Currently,
EPA Guidance Document EPA QA/R-5, "EPA Requirements for Quality Assurance
Project Plan for Environmental Data Operations" is used in preparing QAPPs. Updated
QAPP (QA/R-5) guidance is under review and will be implemented upon final approval.
Implementation of each QAPP will be evaluated by the respective Division or Program
Office. The QAT will provided oversight through audits, Management System Reviews
(see Section 2.2.7 below) and other means.
QAPPs will be reviewed by personnel designated by the originating Division or
Office. All personnel conducting reviews must have a working knowledge of the
Program and/or Divisional Data Quality Objectives, and training in QAPP review (See
Chapter 3 on Training). QAPPs are not reviewed as stand alone documents. Rather
they are reviewed in the context of the broader project objectives for current and future
investigations, and may be reviewed by a team of subject area experts who will provide
specific project recommendations. This information, used in conjunction with the
Quality Assurance review, allows the Project Manager or Divisional designee to assign
an approval status for the QAPP. The Divisions' Quality Assurance Coordinator is
responsible for ensuring that all QAPPs receive a quality assurance review, are in
approval status prior to sampling, and signed by the Project Officer/Manager.
2.2.3.1 Intramural (In-house) Projects
The Quality Assurance Team will provide technical assistance, as necessary, in
the development of the QAPP for each data generation activity. Each QAPP must cite
the specific QMP, and its effective date, that it is guided by. The QA Team and the
Divisional QA Coordinators will evaluate the implementation of these plans through
Technical Systems Audits and Management Systems Reviews.
2.2.3.2 Extramural Projects (Grants, Contracts, Interagency Agreements)
Projects covered in this category are subject to the Quality Assurance
requirements described in 40 CFR Parts 30 and 31, 48 CFR part 15 subpart46.2 and
EPA Order 1900.2. The fulfillment of these requirements is the responsibility of the
respective Divisions and Program Offices. The oversight and implementation
procedures will be described in the Divisional QMPs.
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Region III Quality Management Plan September, 1996
Chapter 2 Region Ill's Quality System Page 2-5
2.2.4 QA Status Reports
Each QAPP for environmental data collection must include a section discussing
the frequency, content, and format of the required QA status report(s). These factors
are determined by the relevant Project Officer and Region III QA personnel. The status,
reports are submitted to the Division or Office QA Coordinator and QA Team, and will
be used to help track the progress of QAPPs throughout the Region. Each status
report must address, as a minimum, the following elements:
IStatus of project
IChanges in project activities (sampling, quality control measures, analytical
methods)
IResults of performance and systems audits
lAny Corrective Actions taken
IProject Organization changes
lAssessment of data quality indicators (precision, accuracy, completeness,
representativeness, and comparability)
Divisional or Office QMPs will contain program/process specifications for QA
status reports.
2.2.5 Standard Operating Procedures (SOPs)
The use of Standard Operating Procedures (SOPs) in Region III serves as one
mechanism to ensure comparability across programs and individual environmental data
collection projects. SOPs must be incorporated either in full or by reference in the
QMPs and QAPPs. SOPs developed for use in Region III must be peer reviewed and
receive approval by the QA Team or Divisional designees as appropriate. SOPs are
tracked and maintained by the QA Team and designated Divisional contacts as
described in the respective Division's QMP.
2.2.6 Technical Systems Audits (TSA)
All programs that employ environmental sample collection and analyses are
subject to a TSA. The TSA involves a thorough review of the facilities, equipment,
sampling and analysis procedures, documentation, data validation and management,
training procedures and reporting aspects of the technical system for collecting or
processing environmental data. TSAs may be routinely planned by the QA Team,
specifically requested by a program, or result from other audit or review findings. The
QA Team is responsible for scheduling the TSA, assembling the audit team, and
participating in the TSA. Results will be reported to the audited organization in the
form of a written report. See Chapter 9 for a further discussion of TSAs.
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Region III Quality Management Plan September, 1996
Chapter 2 Region Ill's Quality System Page 2-6
2.2.7 Management System Reviews (MSR)
Management System Reviews (MSRs) will be performed for each major Region
III Division and Program Office at least once every three years. The MSR will
qualitatively assess a program's organization and data collection procedures to
determine if the quality system in place is adequate to ensure the quality of the
program's data. The Quality Assurance Team is responsible for assembling the audit
team and coordination of audit activities. The RQAM, DQACs, and representatives
from outside the audited program's division will conduct the audit using current Quality
Assurance Division Guidance. Results of any MSRs conducted will be promptly shared
with the Division or Program's senior management upon completion of the review (but
prior to a final written report). The senior management of the organization reviewed is
responsible for taking any necessary corrective actions and determining whether
additional audit activities are required.
2.2.8 QA Annual Report and Workplan
At the beginning of each fiscal year, the Regional Quality Assurance Manager
will develop, after consulting with the Divisional QA Coordinators and the QA Council, a
QA status Report and Workplan (QAARWP). This combined report shall be submitted
to Regional Management and to the Director of the QAD. The QAARWP shall reflect
the implementation status of the Region III QA Program. The Work Plan shall describe
major planned QA activities for the coming fiscal year, including specific planned audits
and audit responsibilities.
The QA Report/Work Plan shall contain the following information as a minimum:
o Implementation Status of the Regional QA Program.
o Revisions to the Regional Quality Management Plan.
o Significant QA related needs, i.e., new policies, changes to existing policies,
guidance documents, audit protocols, etc.
o Data Quality Objectives.
o Status of QA Programs/Projects and Standard Operating Procedures.
o Audits conducted or planned.
o Resource changes.
o Training plans and needs.
In addition to the regular communication/reporting activities described above,
the RQAM shall participate in monthly QAD conference calls and Annual
Management/Technical meetings.
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Region III Quality Management Plan September, 1996
Chapter 3 Personnel Qualifications and Training Page 3-1
CHAPTER 3 PERSONNEL QUALIFICATIONS AND TRAINING
3.1 POLICY FOR QA RELATED TRAINING
The purpose of this Chapter is to explain the processes used by Region III to
ensure that staff and managers working in the various environmental programs are
trained and qualified to perform their required QA responsibilities . This includes
project managers, laboratory staff, field personnel, members of the Regional QA Team,
Division and Office QA Coordinators, data processors, modelers and the individuals
who manage and supervise these personnel.
3.1.1 Responsibilities
First line supervisors are responsible for ensuring that each staff member
involved with collecting or analyzing environmental data has the necessary technical,
quality assurance and project management training and certifications required for their
assigned tasks and functions. Supervisors are also responsible for ensuring that
technical staff maintain the necessary level of proficiency to effectively meet QA
responsibilities. QA training and additional development needs will be identified as
part of the mid-year and annual performance discussions, and during preparation of
Individual Development Plans (IDPs).
Maintaining staff proficiency in critical technical disciplines (e.g., laboratory
microbiologist, toxicologist, environmental engineer) is the joint responsibility of the
individuals filling those positions and the responsible program manager and/or
supervisor.
The individual Divisions and Program Offices, through their Quality Assurance
Coordinators, and with necessary assistance from the Regional QA Manager or Officer,
are responsible for identifying needed QA training within their organizations. The
RQAM is responsible for arranging or providing for the training needs so identified.
3.1.2 Identification of Training Needs
Generally, QA related training needs are assessed by first estimating which
personnel within each organization (Division or Program Office) have QA related
responsibilities, what specific types of QA functions they perform, and with what
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Region III Quality Management Plan September, 1996
Chapter 3 Personnel Qualifications and Training Page 3-2
frequency. These estimates are conveyed by the organization's QA Coordinator to the
Regional QA Manager, who develops an appropriate training program in response.
First line supervisors will identify program specific training needs, including those for
critical technical disciplines.
3.1.3 Implementation of Training Requirements
Staff are encouraged by supervisors to draw upon their educational background,
experience, professional symposia, and on-the-job training to enhance their
understanding and performance of QA related procedures.
The Regional QA Manager and QA Team will coordinate QA training with the
Region III Training Institute and Quality Assurance Division (QAD) staff. The QA Team
will arrange or make known the following courses at a schedule and frequency suited to
meet the needs of Region III and state employees with QA responsibilities.
1. Orientation to Quality Assurance Management
2. Data Quality Objectives
3. Preparing Quality Assurance Project Plans
4. Reviewing Quality Assurance Project Plans
The first two courses will be offered regularly throughout the year and will be
open to anyone responsible for QA functions. The QA Team will also work with the
Division QA Coordinators to schedule additional training for staff preparing or reviewing
QA Project Plans on an as-needed basis.
Members of the QA Team, the Regional QA Manager and Officer, and Division
and Program Office QA Coordinators are expected to take, or have taken, all of the
above courses, or their equivalent, within two years from the effective date of this QMP.
In addition, they are encouraged to to attend meetings and seminars, and to take
formal training, to enhance their understanding of the technical programs and
procedures they work with.
All staff and managers responsible for implementing QA and QC procedures
must attend "Orientation to Quality Assurance Management" as a minimum. Project
Officers who review QMPs and/or QAPPs must complete, in addition to the Basic
Project Officers training, courses 1, 2, and 4 above (within two years from the effective
date of this QMP). Individuals who review and approve QAPPs must be authorized to
do so by their QA Coordinator. The Regional QA Manager will set forth requirements
for such authorization. Individuals who are preparing QMPs or QAPPs should
complete courses 1, 2, and 3 above as a minimum.
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Region III Quality Management Plan September, 1996
Chapter 3 Personnel Qualifications and Training Page 3-3
3.1.4 Assurances for Grants and Contracts
Project Officers/Managers and Work Assignment Managers (WAMs) are
responsible for ensuring that all grant recipient or contract personnel involved with data
generation have the necessary QA training to successfully complete their granted or
contracted tasks and functions. Minimum QA training requirements should be
described in Requests for Proposals (RFPs), all specific Statements of Work (SOWs)
or similar documents, and in grant applications and/or conditions.
In addition, the Regional QA Manager will work with the Region III Training
Officer to ensure that fundamental training courses for grants and contracts include
segments addressing QA requirements and responsibilities for Project Officers and
WAMs.
3.1.5 Documentation of Training
The QA Team will keep a record of all QA training taken by staff and managers
responsible for environmental data generation. This list will also be kept on file with the
Regional Training Officer. Plans for upcoming Regionwide QA training will be
described annually in the QA Report and Workplan.
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Region III Quality Management Plan September, 1996
Chapter 4 Procurement of Items and Services Page 4-1
CHAPTER 4 PROCUREMENT OF ITEMS AND SERVICES
It is'Region III policy that all Extramural Agreements and Procurement involving
environmentally related measurements or data generation require suppliers (i.e.,
contractors, subcontractors, or financial assistance recipients) to have a Quality
Management System in accordance with EPA requirements (EPA QA/R-2).
Procurement, Contracts, Grants, Interagency Agreements (lAGs) and their related
actions are covered by this policy. In general, a Quality Assurance Management Plan
must be reviewed and approved by the Region before the formal execution of any
agreement or related action. Subsequently, the organization must submit a Quality
Assurance Project Plan (QAPP) for the Region's review and approval before any
environmental measurements or data collection activities can be performed.
4.1 CONTRACTS
The Office of Superfund conducts and oversees assessment, remedial, and
removal activities at hazardous waste sites in Region III. For some of these activities,
the Region contracts directly for environmentally related measurements or data
generation. The Region also utilizes existing contracts placed by Headquarters or
other EPA organizations for Superfund and other programs (e.g., Air, Water). Work
Assignments, Delivery Orders, etc. are then issued by the Region for services under
these contracts.
Where contracts and related actions involve the collection of environmental
data, the Regional Quality Assurance Manager (RQAM) or his/her designee shall be
involved in the contract development and execution process as follows:
Statement of Work--QAM reviews statement of work and provides QA tasks
where required.
Acquisition Plan-QAM and Project Officer define QA oversight role in
acquisition process.
RFP Development-QAM incorporates QA activities into evaluation as needed,
including QA in sample work assignment, Quality Management Plan, and Quality
Assurance Project Plan.
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Region III Quality Management Plan September, 1996
Chapter 4 Procurement of Items and Services - Page 4-2
RFP Evaluation-QAM serves on selection board (over $500,000) to score
specified QA submissions.
Contract Award--QAM participates in debriefing.
Work Assignments and Delivery Orders--QAM monitors work assignments
which require QAPP and monitors QA activities.
In order to document compliance with the above policy, the Project Officer and
the RQAM will jointly prepare a Quality Assurance Review Form (EPA Form 1900) for
each new contract, contract modification, work assignment or delivery order. If the
action involves environmental measurements, Part III of the Form will be completed
stipulating the Quality Assurance Requirements addressing functions such as (1)
procurement source evaluation and selection, (2) evaluation of objective evidence of
quality furnished by the supplier, (3) source inspections, (4) supplier audits, and (5)
examination of deliverables. Both the Project Officer and QA Manager or QA Officer
will sign the Form and attach it to the Procurement Request for the applicable action.
The Regional Contracting Officer will assure that a completed Form accompanies the
Procurement Request (Monetary Actions). For Non-monetary actions (e.g., time or
scope changes having no dollar impact), a Quality Assurance Review Form will also be
completed and forwarded to the Contracting Officer. The Contracting Officer will also
assure that there is a stipulation in the contract action that a Quality Assurance Project
Plan will be submitted by the contractor and approved by the Quality Assurance
Manager or Officer before any environmental measurements or data collection
activities are performed.
All procurement of services involving Federal Information Processing Standards
resources must meet the requirements of the FAR, the Federal Information Resources
Management Regulations (FIRMR), Delegation 1-84 (1200 TN310), OIRM Delegation
1-1OA (September 27, 1991), OARM's EPA Acquisition Regulations, Chapters Four and
Six OIRM's Information Resources Management Policy Manual (July 1987) and Region
III Order 5361.5 Site Location Identification Policy and Responsibilities.
4.2 SMALL PURCHASES
Procurement of environmentally related measurements or data generation which
qualify for small purchases under the FAR will be subject to Quality Assurance
requirements. In Region III these actions are generally for analytical services obtained
under an existing Headquarter's contract. The Project Officer from the applicable
Division and the QAM or QAO will jointly prepare a Quality Assurance Review Form for
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Region III Quality Management Plan September, 1996
Chapter 4 Procurement of Items and Services Page 4-3
each procurement. If the action involves environmental measurement, Part III of the
form will be completed stipulating the Quality Assurance Requirements. Generally, a
Quality Assurance Program Plan (or similar documentation) has previously been
provided and approved as required in the original contract award. The Regional
Contracting Specialist will assure that a completed Form accompanies the Procurement
Request. Also, the Contracting Specialist will assure that there is a stipulation in the
Procurement Action that a Quality Assurance Project Plan will be submitted and
approved by the Quality Assurance Officer before any environmental measurement or
data collection activities are performed.
Procurements qualifying as small purchases must meet established
administrative and QA requirements of the FAR, FIRMR, Delegation 1-84 (1200
TN310), OIRM Delegation 1-1OA (September 27, 1991), ARM'S EPA Acquisition
Regulations, and Chapters Four and Six of OIRM's Information Resources
Management Policy Manual, July 1987 and Region III Order 5361.5 Site Location
Identification Policy and Responsibilities. The purchase of computer hardware must
also conform with the April 1, 1993 Executive Order Number 12845 titled Requiring the
Agency to Purchase Energy Efficient Computer Equipment.
4.3 GRANTS AND COOPERATIVE AGREEMENTS
All applicants for grants and cooperative agreements under which environmental
measurements or.data generation are performed must have an approved Quality
Management Plan before an award can be made. If the applicant already has an EPA
approved Quality Management Plan and it covers the project than the applicant need
only reference that plan in their application. Before any environmental measurements
or data collection activities can be performed, the grantee, in addition, must submit a
Quality Assurance Project Plan for review and approval according to the applicable
Region III Division, Office or Program QMP procedures. s
In order to document compliance with the above policy, for grant or cooperative
agreement actions (including amendments), the Project Officer will indicate in the
Program Decision Memorandum (Program Office Authorization for the Award) if Quality
Assurance Requirements apply. If yes, then a Quality Assurance Review Form signed
by the Project Officer and the Regional Quality Assurance Manager or Officer
indicating that a Quality Assurance Management Plan has been approved must be
included in the award package. Awards cannot be made without such approval. In
addition, the Review Form will indicate if a Quality Assurance Project Plan (QAPP) has
been approved. If not, then a condition will be. included in the grant or cooperative
agreement stating that a QAPP must be submitted and approved before environmental
measurement or data collection activities can be performed.
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Region III Quality Management Plan September, 1996
Chapter 4 Procurement of Items and Services Page 4-4
The Grants Specialist will assure that a completed Quality Assurance Review
Form is included in grant award packages where QA requirements apply and also will
include a condition in grant awards requiring a QAPP. This policy applies to all grant
and cooperative agreements awards and amendments.
The requirements for QA are contained in 40 CFR Part 30.54 for universities and
other non-profits, 40 CFR Part 31.45 for States, tribal, and local governments, Regional
Order 5360.50 Quality Assurance Program Policy and Responsibilities and Regional
Order 5361.5 Location Identification Policy and Responsibilities.
4.4 INTERAGENCY AGREEMENTS (lAGs)
All lAGs with environmental measurement activities which Region III funds, or
participates in, will require an approved Quality Management Plan before an IAG is
executed. Where Region III is providing funds to another organization, that
organization is responsible for preparing the QMP. If the external organization has
equivalent requirements to EPA's for Quality Management Systems and Plans, then
their procedures may be acceptable. If there are not comparable QA procedures, the
QA procedures agreeable to both parties must be negotiated prior to execution of the
IAG. Before any environmental measurements or data collection activities can be
performed, the external organization must submit and have a Quality Assurance Project
plan approved or successfully negotiated and acceptable to both parties.
In order to document compliance with the above policy, the Project Officer will
indicate in the Program Decision Memorandum (Program Office Authorization for the
Award) if Quality Assurance Requirements apply. If yes, than a Quality Assurance
Review Form, signed by the Project Officer and the Regional Quality Assurance Officer,
indicating that a Quality Assurance Management Plan has been approved must be
included in the award package. Awards cannot be made without such approval. In
addition, the Review Form will indicate if a Quality Assurance Project Plan (QAPP) has
been approved. If not, then a condition will be included in the IAG stating that a QAPP
must be submitted and approved before environmental measurement or data collection
activities can be performed.
The Grants Specialist will assure that a completed Quality Assurance Review
Form is included in IAG packages where QA requirements apply and also will include a
condition in the IAG requiring a QAPP. This policy applies to all lAGs and
amendments.
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Chapter 4 Procurement of Items and Services Page 4-5
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Region III Quality Management Plan September, 1996
Chapter 5 Documentation and Records Management Page 5-1
CHAPTER 5 DOCUMENTATION AND RECORDS MANAGEMENT
Maintaining important QA documents and records is a continuous process at
EPA Region III. This process serves as a vehicle for identifying quality-related
documents and records requiring management control. Moreover, this process serves
to assure that QA documents and records are accessible and protected in storage from
damage and deterioration. Finally, the process ensures compliance with all statutory,
contractual, and assistance agreement requirements for records from environmental
programs, while providing adequate preservation of key records necessary to support
the mission of the Region. QA documents and records are maintained as follows:
5.1.1 National QA Documents
Copies of national guidance or requirements documents issued by the Quality
Assurance Division for QMPs, QAPPs, SOPs and other specific quality practices are
maintained by Region Ill's QA Manager, the Regional QA Officer, QA Team members
and Divisional Quality Assurance Coordinators. They are distributed by these
individuals to appropriate regional staff, states, grant recipients and support
contractors. National QA documents specific to one program area (e.g., Superfund or
the Office of Water QMPs) are maintained by the Quality Assurance Coordinator of the
Division or Office responsible for that program.
5.1.2 Routine QA Operating Documents
Project or site specific QA documents and records generated as part of the
Regional Quality System are used and stored in the various program offices within
Region III. Records and documents associated with a given project are the
responsibility of the Division that has primary responsibility for that project. Hard
copies of site or project specific information such as sample field sheets, chain-of-
custody records, laboratory notes, field notes, and instrument readings shall be
maintained by the responsible program office. These records provide support to the
validity of the environmental data for making decisions. [However, this information will
not be included within a central database]. Projects involving the generation of
environmental data shall include, as a minimum, the QAPP and final report, which
should be stored together, allowing a subsequent analyzer or investigator to
understand the full context of the data produced and the conclusions reached. Division
and Office QA Coordinators shall be responsible for maintaining QA documents for a
period specified in their Divisional QMP.
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Chapter 5 Documentation and Records Management Page 5-2
5.1.3 In-House QA Guidance Documents
Quality guidance documents developed in-house are peer reviewed by QA staff
personnel and the appropriate program office. Most of the in-house quality guidance
documents are formatted as SOPs covering specific environmental monitoring activities
such as field inspections; sample collection/handling; analytical protocols; and data
review/validation. The QA Team has developed an extensive list of SOPs which have
been peer reviewed and approved for Regional use. QA directives have also been
developed by this group. These documents are on file at OASQA and the Regional
Office library and specific program offices.
5.1.4 Other QA Documents
QMPs developed by Region III Divisions and Program Offices or by state
agencies are reviewed by Regional QA Team staff and program officers of the
respective program office. Copies are retained by both the QA Team and the relevant
program office. QAPPs submitted to Region III are also peer reviewed by'the
respective program manager/project officer, appropriate EAPD staff and Region III QA
staff. Copies are retained by the Project Officer and QA reviewers.
5.1.5 Peer Review
On June 7, 1994, the EPA Administrator issued a Policy requiring mandatory
peer review of major scientific work products. As a result, Region III established a
Standard Operating Procedure (SOP) which formalizes peer review. The SOP
establishes the Region III Peer Review Group and specifies an annual reporting cycle
which must be completed under the Regional Administrator's signature. Criteria for
identifying major scientific and technical work products subject to this SOP include:
o Supports major regulatory decisions or policy/guidance of major impact
o Establishes a significant precedent, model, or methodology
o Addresses controversial issues
o Focuses on significant emerging issues
o Has significant cross-Agency/inter-Agency implications
o Involves a significant investment of Agency resources
o Considers an innovative approach for a previously defined
problem/process/methodology
o Satisfies a statutory or other legal mandate for peer review
5.1.6 Document Tracking
A database of all Regional QMPs, QAPPs and other important quality
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Region III Quality Management Plan September, 1996
Chapter 5 Documentation and Records Management Page 5-3
documents shall be maintained by the Quality Assurance Team. This database will
include information similar to that required by the QTRAK system used by several EPA
organizations for tracking quality documents. All QMPs submitted to the QA Team for
review and approval will be entered into this system. QAPPs are not required to be
submitted to the QA Team, however basic information regarding the QAPPs must be
provided to the QA Team so that these documents can also be tracked. Division and
Office QA Coordinators will provide QAPP information to the QA Team. QMPs and
QAPPs are not considered to be approved unless they are entered into the Regional
quality database. All QMPs and QAPPs, regardless of approval status, must be
tracked to assure timely review, approval or re-submission, and to be able to inform
internal and external customers of the status of any QA document at any time.
5.1.6 Disposition of Documents and Records
The Quality Assurance Team in conjunction with Division Quality Assurance
Coordinators ensures that all QMPs and QAPPs are current. Should one of these
documents become outdated, the Regional QA Manager or QA Officer shall determine
the status of the plan, and initiate appropriate action. All quality assurance documents
or copies thereof which are sent to, generated by, and/or sent from the Quality
Assurance Team will be filed after action in a central EAPD file room. These
documents will be maintained under the supervision of a file clerk. Short and long term
storage shall be maintained in a place and for a period of time to be decided by each
Division/Office Director (with advice from the QA Coordinators) in accordance with the
EPA's Records Management Manual (Classification Number 2160, OIRM, 1984) and
similar governing policies. The Director represents the final custodian of that
information.
5.1.7 Maintaining Document Integrity
Following all appropriate action, the file clerk will take special care to preserve
the integrity of sensitive documents such as audit reports and performance evaluation
reports. This special care includes such precautions as locking these files in the
absence of the file clerk. If sensitive documents are to be used at a work station, due
care will be used there, too, in order to maintain the integrity of the data.
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Region III Quality Management Plan September, 1996
Chapter 6 Computer Hardware and Software Page 6-1
CHAPTER 6 COMPUTER HARDWARE AND SOFTWARE
In order to ensure the effective and efficient use of the Regional ADP systems,
including hardware and software system design, development, implementation and
maintenance, Region III will comply with all EPA standards and regulations pertaining
to hardware, software, system development, and data. It is a Region III goal to achieve
consistency in the way data are generated, compiled, stored and disseminated across
all Regional programs.
6.1 COMPUTER HARDWARE/SOFTWARE REQUIREMENTS
Region III managers and staff will comply with all hardware and software
standards delineated in the Enterprise Technology Systems Division (ETSD) Guidance
on Hardware and Software Standards. These standards address Compatibility,
Hardware, Operating Systems, Communication, Database Management, User
Interface/Printer Interface, Application Development and Applications.
Region III will procure Agency-approved hardware and software that conforms
with Agency-wide information management architecture. In some cases the Region will
buy or develop hardware or application software that is not on the Agency contract. All
such purchases will be evaluated to ensure that they comply with Agency standards in
the ETSD Guidance on Hardware and Software Standards. Prior to any purchases, the
PC Site Coordinator will evaluate software or hardware to determine it's performance
capabilities and impact of the change.
6.2 SYSTEM DEVELOPMENT $
All Region III Information Resource Management (IRM) system development,
enhancement and modernization efforts will comply with OARM's System Design and
Development Guidance. This compliance should include a systematic and
comprehensive dialogue between the data providers, data/system users and system
developers, prior to the design of the system in order to ensure extensive user
participation and a systematic approach.to the design.
All software systems shall be operated and maintained according to the OARM
Operation and Maintenance Manual. Compliance with applicable IRM Standards will
ensure that all hardware and software configurations are tested.
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Region III Quality Management Plan September, 1996
Chapter 6 Computer Hardware and Software Page 6-2
For proper implementation and maintenance of the ADP system, the appropriate
Divisions shall provide:
- A written description of the computer system(s) hardware and written operating
procedures for routine maintenance operations. Documentation should be developed
to include a written description of the computer system(s) hardware and written
operating procedures which describe the routine operation, maintenance and testing, to
ensure that both the hardware and software in use is accurately performing the
intended functions;
- A written document which contains a detailed description of the software in
use, including the listing of all algorithms or formulas used for data generation,
processing and assessment, clear guidelines for data acceptance criteria, criteria for
data validation/invalidation, data deletion/addition, and data correction; and
- Standard Operating Procedures which describe the routine operation,
maintenance and testing, to ensure that both the hardware and software in use is
accurately performing the intended functions.
These documents should be readily available in the areas where these
procedures will be performed. Changes in any part of the operating procedures shall
be properly authorized, reviewed and accepted in writing by the designated responsible
person.
6.3 DATA STANDARDS
To take full advantage of the Region's growing technological and data
resources, there needs to be an increased emphasis on improving compatibility of data
among the systems. For consistent definition of data, and to facilitate cross-media use
of data, all data produced or collected by the computers shall be managed as specified
in the Agency IRM Policy manual. Region III will incorporate Agency data standards as
listed in the Agency Catalogue of Data Policies and Standards (Draft). This catalog will
summarize Federal data policies and standards which are'the definitive list of data
standards that Agency personnel, contractors, grantees, and other governmental
organizations must meet when developing information systems. Critical standards that
will be followed include:
Chemical Abstract Service Registry Number Data Standard, EPA Order 2180.1,
June 26, 1987;
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Region III Quality Management Plan September, 1996
Chapter 6 Computer Hardware and Software Page 6-3
Data Standards for the Electronic Transmission of Laboratory Measurement
Results, EPA Order 2180.2, December 10, 1987;
The Minimum Set of Data Elements for Ground Water Quality, Policy Order
74500.IA, September 11, 1989;
Facility Identification Data Standard, U.S. EPA Office of Administration and
Resources Management, Information Management and Services Division, April
9, 1990;
Policy on Electronic Reporting, U.S. EPA Office of Administration and Resources
Management, July 30, 1990;
Site Location Identification Policy and Responsibilities, Region III Order 5361.5,
September 14, 1988;
Locational Data Policy, IRM Policy Manual, Chapter 13, April 1991;
Locational Data Policy Implementation Guidance - Guide to the Policy, U.S. EPA
Office of Information and Resources Management, March 1992.
EPA's data-related policies apply to all EPA organizations and personnel,
including contractors, grantees and other governmental organizations who design,,
implement, and maintain information management systems for Region III. The Region
will incorporate Agency data standards into all data collection activities and into new or
modernized information management systems.
6.4 INFORMATION SECURITY
It is important that the Region's information resources are protected from
potential loss and misuse from a variety of accidental and deliberate causes. For a
comprehensive, Region-wide security program to safeguard the Region's information
resources, all information resources shall be safeguarded as specified in the EPA
Security Manual.
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Region III Quality Management Plan September, 1996
Chapter 7 Quality Assurance Planning Page 7-1
CHAPTER? QUALITY ASSURANCE PLANNING
A major goal of Region Ill's Quality System is to promote effective planning for
the collection, analyses and processing of environmental data. Quality planning must
occur at three levels to ensure that such data meets Regional programmatic and quality
goals:
• Region-Wide;
• Program-Specific; and
• Project Level.
7.1 REGION-WIDE PLANNING
7.1.1 Internal Strategic Planning
The Regional Strategic Plan is the foundation upon which all programmatic
priorities and corresponding environmentally related data collection and use activities
are based. Using the projected annual budget for the Region and guidance from the
various program offices in EPA Headquarters, the Regional Administrator and the
senior managers (Division and Office Directors) usually meet early during the fiscal the
year to discuss and set Regional priorities. These priorities are then reflected in the
Regional Strategic Planning process, which establishes overarching goals, directions,
resource utilization policies and budget allocations. Yearly action plans developed by
the individual Divisions, tied to the Strategic P|an and budget distribution process,
further specify the types of environmentally-related data generation activities that will
occur, for what decisions they are designed to support, and the corresponding
requirements for quality assurance and quality control procedures.
t
7.1.2 External Data Coordination
The Region must also coordinate the collection and use of environmentally
related data across numerous government agencies, and also academic and private
organizations. Close coordination and planning is essential to ensure that data are of
sufficient quality to support decision-makers or otherwise meet the intended uses, and
can be shared where Data Quality Objectives (DQOs) are similar. The Region
encourages data sharing wherever possible, provided adequate data descriptors are
available so that the quality of the data is sufficiently known to support the applicable
decision(s).
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Region III Quality Management Plan September, 1996
Chapter 7 Quality Assurance Planning Page 7-2
7.1.3 Annual QA Plan
During October of each year, the QA Team will prepare a QA Report and
Workplan which summarizes past fiscal year accomplishments, and outlines planned
QA actions for the upcoming year. Included in this Report will be a description of
specific audits and evaluations to be performed. The Report will be submitted to the
QA Council and to the Region's senior managers, and shared with personnel who are
involved with QA activities in the Region.
7.2 PROGRAM-SPECIFIC PLANNING
Programs are functional areas of work authorized by Statutory reference (e.g.,
the Air Toxics Program) or by Executive or Agency direction (the Volunteer Monitoring
Program). Any of the Regional environmental programs which generate environmental
data are covered by this QMP, though not all require the same level of quality
assurance. Generally, program managers (their grades and titles vary by
Division/Office) are responsible for program level planning, which includes the
responsibility to ensure that there is agreement between the customer and the data
supplier as to expected data quality.
Developing Data Quality Objectives (DQOs) when initiating a new program or
incorporating major statutory changes is a mandatory component of QA planning at the
program level. The Quality Assurance Division guidance document Guidance for The
Data Quality Objectives Process (EPA QA/G-4) is available to assist users in
developing these objectives. DQOs at the program level include all sources of error
(i.e., design, sampling, measurement, or indicator error) that will accumulate and affect
the interpretation of data for status and trends. Program-level DQOs are defined by
their ability to meet Regional program objectives discussed with desired certainty. Data
Quality Objectives are used as performance criteria for assessments of data quality for
their adequacy in determining status and trends.
For many ongoing environmental monitoring programs, the National Program
Offices at EPA Headquarters have already developed DQOs. In these cases, Region
III simply uses the national guidance and DQOs, and incorporates them by reference
into the applicable QAPP.
It is critical to consider this QMP as part of the planning process when modifying
existing programs or designing new programs. Although this QMP outlines the
minimum QA requirements for the Regional programs, it is likely that most of the
programs covered by this QMP will need more QA specificity and detail for
implementing their programs. In these cases, supplemental QA components and
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Region III Quality Management Plan September, 1996
Chapter 7 Quality Assurance Planning Page 7-3
procedures should be developed and described in the Division or Office QMP.
They will also be referenced in future revisions to this QMP. The QA Team will serve
as technical advisors in the development of these procedures and documents. All
programs covered by this QMP should review their program needs within the next year
to determine whether this QMP adequately covers their QA needs, and develop
supplemental procedures as necessary.
7.3 PROJECT LEVEL PLANNING
A project is an organized set of activities within a program. The Quality
Assurance Project Plan (QAPP) is the primary vehicle for ensuring adequate data
quality at the project level (see Chapter 2, Section 2.2.3 for a more'complete discussion
of the QAPP development and review process). QA activities will be described as a
well-defined component of any project plan involving the collection or use of
environmental data.
The key to good quality planning at this level is to link the data collection or
analyses to be performed directly to the environmental decision to be made, so that the
Region is not collecting mounds of data for which it has no use or purpose. Achieving
this key requires a dialogue between the decision maker (the "customer") and the data
supplier. Again, QAD document EPA QA/G-4, Guidance for The DQOs Process, can
be invaluable in establishing the desired data certainty requirements based on the
decision to be supported.
The use of statistical methods to quantify data acceptability measures is highly
recommended. Members of the QA Team in Annapolis can provide assistance with
statistical applications. In addition, EPA Region III recently offered a graduate level
training course on statistical analyses tools which is being taken by approximately 30
Regional employees. The individuals completing this course are expected to possess
enough knowledge necessary to assist with QA project level planning and data review,
as well as design of DQO processes. In cases where special expertise is needed, the
Region will consider use of available QAD contract support for statistical analyses.
Since the Region employs a decentralized QA system, the Regional Quality
Assurance Manager is not directly involved in the Data Quality Objectives
(DQO)/QAPP planning process or data quality assessment. However, the QA Team is
involved with training and provides assistance with QAPP development as requested.
Also, technical expertise is typically available from a variety of personnel within the
Region for such subject areas as sampling protocols, analytical methods and QA and
QC procedures.
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Region III Quality Management Plan ' September, 1996
Chapter 7 Quality Assurance Planning Page 7-4
Planning documentation should identify the personnel responsible for all
components of the QAPP described therein. Project Officers or Managers will normally
be responsible for the development of these QA components, which will adhere to the
requirements of EPA QA/R-5, EPA Requirements for Quality Assurance Project Plans
for Environmental Data Operations. As part of the project planning, Project
Officers/Managers will adhere to the procedures specified within each Division or Office
QMP for the development, review and approval of the QAPP. Division or Office QA
Coordinators, with assistance as necessary from the RQAM or RQAO, will be involved
in the project planning process, and will approve in writing each QAPP developed
within their organization.
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Region III Quality Management Plan September, 1996
Chapter 8 Implementing QA Procedures Page 8-1
CHAPTER 8 IMPLEMENTING QA PROCEDURES
This Chapter of the QMP describes the processes used in the Region for
ensuring that the QA plans and procedures which comprise the Quality System are
effectively implemented. As with QA planning described in the previous Chapter,
implementation of QA procedures takes place at Regional, program and project levels.
8.1 REGION-WIDE IMPLEMENTATION
Region III utilizes a decentralized approach to ensure that environmental data is
of sufficient quality for its intended purpose. This Regional QMP requires each Division
and Program Office in the Region that generates environmental data to develop its own
specific Division or Program QMP which will address, at a minimum, the requirements
set forth by EPA's Quality Assurance Division as outlined in EPA QA/R-2 (and future
updates). Any revisions to this QMP or the Division/Office QMPs will be processed in
the same manner as the original documents. The QA Team, Regional QA Manager,
and Regional QA Officer will provide general oversight of implementation of the
Regional Quality System. The Divisions and Program Offices will provide technical
oversight for implementing .environmental data operations. The Divisional QA
Coordinators are responsible for determining the need for written QA procedures within
their organizations.
8.1.1 Division and Office QMPs
Each Division or Office QMP will contain specific implementation procedures
that identify those first line managers with direct implementation responsibilities. Each
Divisional QMP will address the process for implementing environmental data
operations according to the approved planning documents.
Additionally, each Division or Office QMP will identify those specific activities
that will ensure the generation of quality data by:
o Identifying mission elements and/or programs generating or using data for
environmental decisions;
o Identifying criteria for collecting or selecting data sufficient to support
environmental decisions;
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Region III Quality Management Plan September, 1996
Chapter 8 Implementing QA Procedures Page 8-2
o Describing procedures for the preparation, review and approval of QAPPs;
o Outlining procedures to ensure that the work described in the QAPP is being
performed according to the Plan, including evaluation activities;
o Ensuring that individuals with QA responsibilities have been properly trained;
and
o Defining the level of management oversight and inspection to be
provided that will be commensurate with the importance of the particular project
and the intended use of the project results.
8.2 PROGRAM LEVEL IMPLEMENTATION
8.2.1 Operating Policies and Procedures
Any/Regional program which generates or uses environmental data will
document their responsible QA policies and procedures, and will develop and/or use
appropriate policy and procedures manuals for their programs (the Annapolis
laboratory already has such procedures documented within its Facilities Plan). The
QAD document "Guidance for the Preparation of Operating Procedures for Quality-
Related Operations", QAD/G-6, November, 1995, should be consulted by Regional
programs for developing procedures manuals for administrative and technical QA
operations. Having these procedures available will ensure that program personnel are
knowledgable about their operations, and will also serve as a training guide for new
staff members.
The Regional QA Manager will work with the Regional programs to ensure that
operational QA policies and procedures developed by the programs are consistent with
the Regional QMP. This responsibility includes defining procedures for appropriate
routine, standardized, special, or critical operations, including the policies and
procedures that address, but are not limited to:
- identification of operations needing standardized procedures;
- the process for preparation of procedures, including form, content,
and applicability; and
- review and approval of the adequacy of the SOPs.
Any QA procedures manuals developed by Regional programs will be made
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Region III Quality Management Plan September, 1996
Chapter 8 Implementing QA Procedures Page 8-3
available to all personnel involved in program implementation. If implementation of the
program is delegated, the manuals will be referenced in any assistance or delegation
agreement. Where a program uses data generated by external sources, it must
develop criteria and a process by which to evaluate the acceptability of the data
supplied, in the context of the environmental decision(s) to be made. The data quality
assessment process described in Chapter 9.4 can be useful here.
8.3 PROJECT LEVEL IMPLEMENTATION
8.3.1 QAPP Implementation
All environmental data operations will be implemented in accordance with an
approved QAPP. Any changes to the QAPP will be documented and approved in
writing through an amended QAPP. Amendments will be reviewed and approved by
the original approving officials, including the Division or Office QA Coordinator. The
Project Officer should include identifiable QA milestones and target dates in the project
timeline so that progress and completion of the QA and QC activities can be effectively
tracked.
For contracts and grants involving environmental data generation, the Project
Officer and Division QA Coordinator shall ensure that the applicable Work Assignment,
Task/Delivery Order or similar documentlncludes specific requirements for reports on
the QA of products or services to be supplied.
8.3.2 Standard Operating Procedures (SOPs)
Many repetitive procedures that are routinely used can be standardized and
documented in writing as standard operating procedures (SOPs). SOPs can be
prepared for routinely conducted sampling, analytical, and quality control procedures.
Once established, the SOPs can be cited in QAPPs, contract proposals, grant
agreements, and other similar documents, thus saving time and paper by avoiding the
need to write out the specific procedures in each document. Regional SOPs relating to
QA shall be reviewed and approved by the Regional QA Manager and maintained by
the appropriate program office. Any substantive changes in the SOPs will be likewise
approved by the QAM.
Tasks or functions that may be effectively addressed within a SOP include:
o Sampling network design.
o Sampling site selection.
o .Sampling and analytical procedures.
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Region III Quality Management Plan September, 1996
Chapter 8 Implementing QA Procedures Page 8-4
o Sample collection methods and devices, containers, preservatives,
holding times, handling and transportation methods.
o Documentation and chain-of-custody procedures.
o Calibration and maintenance of instruments and equipment.
o Quality control procedures.
o Data review, reduction and validation.
o Safety procedures.
o Inspection and audit procedures.
8.4 IMPLEMENTATION SCHEDULE
The Quality Assurance Task Force will initially coordinate the schedule for
completion of the Divisional or Program Office QMPs. Following their, completion and
approval, the Quality Assurance Team (QAT) will track their implementation, and will
report progress and any concerns to EAPD senior management at least quarterly.
Where implementation problems are encountered, the Team will work with the
Divisional QA Coordinator to resolve. Program and project level implementation are
primarily the responsibility of the Divisions and Program Offices.
The schedule for major Region III QA efforts over the next several months is as
follows:
Timeline for Implementing the Region III QA System
Activity Target Date Lead
R3 QMP Final Completed August 15, 1996 QA Task Force
R3 QMP Authorization .August 20, 1996 DDs/OHs/DRA/RA
Submittal to QAD August 23, 1996 RA/DRA
R3 QMP Approval September 30, 1996 QAD (HQ)
Establish QA Council September 30, 1996 DRA
Annual QA Report
and Workplan November 1, 1996 QATeam
Division/Office QMPs
(Draft) October 15, 1996 Divisions and Offices
Review Div./Off. QMPs December 1, 1996 RQAM, RQAO
Identify Regional
QA Training Needs December 15, 1996 QATeam
Division/Office QMPs
(Final) January 1, 1997 Divisions and Offices
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Region III Quality Management Plan September, 1996
Chapter 8 Implementing QA Procedures Page 8-5
QAPP Reviews Ongoing Divisions/Offices
Review Program Needs August 1,1997 QA Manager/Team
Revise R3 QMP September 30, 1997 QA Manager/Team
Review Data Generating
Programs August 30, 1998 QA Manager
Complete QA Training September 30, 1998 QA Manager/Team
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Region III Quality Management Plan September, 1996
Chapter 9 Quality Assessment and Response Page 9-1
CHAPTERS QUALITY ASSESSMENT AND RESPONSE
This Chapter of the QMP describes how Region III will assess the effectiveness
of its Quality System. The Region will use a variety of internal management and
technical reviews, performance evaluations and audits to make sure that the
procedures in this QMP are implemented successfully. The Region will also use
independent reviews by personnel from other Regions and/or EPA offices to
periodically evaluate the systems and procedures described in the QMP. This Chapter
will also describe the Region's commitment to using the results of these evaluations to
make any necessary operational adjustments to the Region's data collection and
analytical procedures, as well as to the Quality System itself.
9.1 ANNUAL REVIEW OF THE REGIONAL QUALITY MANAGEMENT PLAN
The QA practices and procedures described in this QMP will be assessed
annually and revised or updated as necessary. The Regional QA Manager is
responsible for coordinating this assessment, arranging for appropriate personnel to
assist with the review, and for incorporating any recommended changes into the
document. Minor changes in the QMP will be reported to QAD and senior Regional
management through the QA Annual Report and Workplan. Any major changes may
require a formal resubmittal of the Plan to QAD.
9.2 REGIONAL AUDITS
Region III employs several assessment tools designed to provide an increased
understanding of the components of its quality system, and to provide a basis for
improving the system. Internal and external audits are one of the principal tools for
determining the effectiveness of the QA components described in the Regional or
Divisional QMPs. Audits of Region III QA programs and activities will be conducted in
accordance with established QAD or other appropriate protocols. Audit frequency and
scheduling varies with the type of audit conducted. Following is a description of some
of these evaluation tools.
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Region III Quality Management Plan September, 1996
Chapter 9 Quality Assessment and Response Page 9-2
9.2.1 Management System Reviews (MSRs)
An MSR is an independent assessment of an organization's QA management
practices. MSRs address the effectiveness of management controls in achieving and
assuring data quality, the adequacy of resources and personnel devoted to QA
functions, the effectiveness of training and assessments, and the applicability of data
quality requirements. MSRs can identify significant QA concerns and areas of needed
improvement, but also point out noteworthy accomplishments.
Organizational MSRs are generally conducted by an external party (typically
ORD/QAD or a QAD directed team) and focus on the organization's adherence to its
approved QMP, QAD attempts to conduct an MSR for every major Agency organization
(including the Regional Offices) once every three or four years (an MSR was last
conducted on Region Ill's QA System in August, 1994). The organizational MSRs
focus on the overall structure and procedures for accomplishing the QA program.
Program MSRs are generally performed by an internal review team and focus on
implementation of QA practices within a single program area. These MSRs will
typically be performed by a Review Committee authorized by the Director of EAPD.
The Review Committee will include representatives of the QATeam, and those with
knowledge of the Regional program under review, and may include staff members,
supervisors and managers.
Most MSRs will examine the following elements:
• An assessment of the overall effectiveness of the QA management system,
as measured by its adherence to the approved QMP;
• Procedures for developing Data Quality Objectives (DQOs);
• Procedures for developing and approving QAPPs;
• The effectiveness of existing QAPP guidance and QAPPs;
• Procedures for developing and approving SOPs;
• Procedures, criteria and schedules for conducting audits;
• Tracking systems for assuring that the QA program is operating and that
corrective actions disclosed by audits have been taken;
• Responsibilities and authorities of various line managers and QA personnel
for implementing the QA program;
• The degree of management support;
• The level of financial and other resources committed to implementing the
QA program;
MSRs performed or arranged by Region III will be conducted in accordance with
Guidance for the Management Systems Review Process, EPA QA/G-3 (now available
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Region III Quality Management Plan September, 1996
Chapter 9 Quality Assessment and Response Page 9-3
in draft form), the related Requirements Document, EPA QA/R-3, when it is finalized,
or future updates.
The Region may also make occasional use of independent, outside reviews of
its quality assurance practices. When electing to use an outside source, the Regional
QA Manager will make arrangements for such a review by selecting, in conjunction with
the appropriate Divisional QA Coordinator(s), an appropriate team of qualified
reviewers from other EPA Regions and/or Headquarters. The goals and objectives of
this type of review will be the same as if the assessment were conducted internally.
9.2.1.1 Review of Division and Office QA Programs
The Region will conduct internal assessments of individual Divisions' quality
assurance programs as described in their QMPs. All major data generating programs
within the Region will be reviewed not less than once every two years. These
programs include Air Quality, Toxics and Radiation, Water Quality, Drinking Water, the
Chesapeake Bay Program, Superfund and RCRA. Included in these reviews will be the
QA practices and QMPs of States, contractors, and other agencies that collect data for
EPA-supported activities.
These reviews will be authorized by the Director of the Environmental
Assessment and Protection Division (EAPD) and will be coordinated by a QMP Review
Committee arranged by the Regional QA Manager. The results of the evaluations will
be transmitted to the relevant Division Director in a written memorandum from the
Review Committee Chairperson. Program-specific recommendations will be provided
to the Divisional QA Coordinator for incorporation into the organization's QMP.
The reviews are intended to accomplish the following objectives:
• Identify any data quality problems.
• Identify benchmark practices that could be used in other Regional
programs.
• Propose recommendations for resolving quality problems.
• Confirm implementation and effectiveness of any recommended
corrective actions.
The reviewed program will normally have 30 days to prepare a written response
to the review memorandum. The response should include an evaluation of the Review
Committee's findings and recommendations. If the Review Committee recommended
corrective actions, the reviewed Division or Office should address those
recommendations and include a schedule for making any appropriate changes in its
quality assurance procedures.
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Region III Quality Management Plan September, 1996
Chapter 9 Quality Assessment and Response. Page 9-4
These reviews will be used by senior Regional managers to gauge the
effectiveness of the Regional QMP and of individual programs' approaches to data
quality management.
9.2.2 Technical Systems Audits (TSAs)
A Technical Systems Audit is conducted to assess the sampling and analytical.
quality control procedures used to generate environmental data. Region III will use
TSAs to evaluate laboratory and field procedures used by EPA and state personnel,
contractors and grantees. TSAs may entail a comprehensive, on-site, evaluation of
facilities, equipment calibration, personnel qualifications and training, record keeping
procedures, data validation, data management and reporting of field and laboratory
activities. Both laboratory and field tSAs are performed.
9.2.2.1 Laboratory TSAs
TSAs will be conducted for State laboratories and for contract laboratories in
Region III that prepare environmental data for use in EPA-sponsored programs. TSAs
will also be conducted for other Federal agency laboratories that perform sample
analysis under Interagency Agreements with Region III. The Region's EAPD Annapolis
laboratory will also be examined on a regular basis.
The primary goals of these audits will be to review the laboratory organization,
operation, and capabilities, determine the reliability of data, and note corrective action
for any apparent deficiencies. Auditors for TSAs will be selected by the Regional QA
Manager based on their technical proficiency in the subject area, and will be
responsible for planning and conducting the audit, and reporting the findings to the
laboratory manager.
9.2.2.2 Field TSAs
Oversight of field operations is an important part of the quality assurance
process, and Region III will conduct audits of field sampling activities, both for its own
field operations, and for those of States, contractors and other federal agencies that
collect samples for programs sponsored by EPA. The Divisional QMPs will specify
frequency and procedures for conducting field TSAs within specific program areas.
The Regional QA Manager will determine the adequacy of field TSAs when QMPs are
reviewed, and also during any MSRs or other audits.
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Region III Quality Management Plan September, 1996
Chapter 9 Quality Assessment and Response Page 9-5
9.3 PERFORMANCE EVALUATIONS
Performance Evaluations (PEs) are conducted to assess the ability of a
laboratory or field measurement system to obtain reliable data. PEs will normally be
accomplished at laboratories providing analytical services directly or indirectly for the
Region. The evaluation consists of providing a reference, or "blind", sample to the
laboratory for analysis. This PE sample contains known concentrations of chemical
constituents, or pollutants, of interest and will normally be in the appropriate media
(e.g., soil, water, air). The analytical results obtained by the laboratory are compared
to the known concentrations of the specific parameters contained in the PE sample(s)
as a means of determining if the laboratory demonstrated its ability to properly identify
and quantify pollutants within established or calculated control limits.
PEs will be scheduled at a frequency specified by program requirements, or on
an as-needed basis depending on the laboratory and program involved. Some national
programs, such as the Public Water Supply Supervision (PWSS) and National
Pollutant Discharge Elimination System (NPDES) programs, have regularly-scheduled
PE studies in which participation is mandatory for designated laboratories. For the
PWSS program, PE evaluations are required twice a year for all laboratories who wish
to be certified for drinking water analysis. Other national programs have regularly
scheduled evaluations, but participation is optional. In addition, PE samples of specific
parameters may be obtained from appropriate EPA ORD laboratories or prepared
locally.
All PEs performed within the Region, whether required on a regular basis or
performed on a one time basis, will be coordinated through or requested from the
RQAM or designee. In the case of the PWSS program, PEs will be coordinated by the
RQAO. The RQAM, or designee, will track and monitor the conduct of PEs and upon
completion, will provide the results to the requestor and the participant, as appropriate.
The results of PEs provide a means for assessing overall data integrity, and may be
used as the criteria for selecting candidates for on-site evaluations.
9.4 DATA QUALITY EVALUATIONS
Data quality requirements and evaluation methods are included in each
Divisional QMP and also in specific QA Project Plans. Each Division and Office QMP
will describe the methods by which data quality evaluations will be conducted and
utilized and how these evaluations relate to the Data Quality Objectives.
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Region III Quality Management Plan September, 1996
Chapter 9 Quality Assessment and Response Page 9-6
9.4.1 Data Quality Assessments (DQAs)
A Data Quality Assessment (DQA) refers to the process used to determine
whether the quality of a given data set is adequate for its intended use, using
appropriate statistical tools. DQAs can be performed on all or selected projects
involving data collection. The purpose of this type of evaluation is to determine
whether the data collected are acceptable to the decision-maker or user for their
intended use, since the data are ultimately meaningful only in this context. A DQA
involves a statistical comparison of the collected data with the Data Quality Objectives
(DQOs) for the project. The intended use of the data is established by the project's
Data Quality Objectives (see Chapter 7). This evaluation and comparison will result in
the determination that the data are useable or not useable for their intended purposes.
Guidance for this procedure is provided in EPA QA/G-9, Guidance for Data Quality
Assessment, July, 1996.
The Regional laboratory in Annapolis routinely reviews and validates data
generated in-house and by contract laboratories for the Superfund program. These
activities use standard operating procedures and standardized qualification codes to
indicate data quality.
9.4.2 Data Quality Audits
A related evaluation tool involving data review and assessment is the data
quality audit which is used to evaluate the documentation of the quality of data
generated for a given project. This assessment primarily involves an evaluation of the
completeness of the documentation of field and analytical procedures and quality
control results; and usually involves tracing the paper trail accompanying the data from
sample collection and custody to analytical results and entry into a data base. It.is
commonly used to verify the process involved in entering data residing in large
regulatory data bases.
Results of both DQAs and data quality audits can be used in a number of ways.
First, they can be used in making recommendations for changes in the design and
performance of data collection efforts, and in the use and documentation of QC
procedures. Secondly, they can be used as a guide for the planning and acquisition of
supplemental data for the project and potentially for other related projects. Problems
identified through DQAs may trigger the need for an MSR to determine management
deficiencies, or a TSR to identify technical problems.
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Region III Quality Management Plan September, 1996
Chapter 9 Quality Assessment and Response Page 9-7
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Region III Quality Management Plan September, 1996
List of References Page R-1
LIST OF REFERENCES
EPA Order 5360.1, Policy and Program Requirements to Implement the Mandatory
Quality Assurance Program, U.S. Environmental Protection Agency, April, 1984.
EPA Requirements for Quality Management Plans (Draft Interim Final), EPA QA/R-2,
U.S. EPA, Quality Assurance Management Staff, August, 1994.
Standard Operating Procedure for Quality Management Plan Reviews, QAD/96-1, U.S.
EPA, Quality Assurance Division, January, 1996.
EPA Information Security Manual (Draft), U.S. EPA Office of Information and
Resources Management, June, 1994.
U.S. EPA Acquisition Regulations, U.S. EPA Office of Administration and Resources
Management.
EPA 1900 - Contracts Management Manual, U.S. EPA Office of Administration,
January 31, 1991.
U.S. EPA Grant Regulations, QA Requirements, 40 CFR Part 30.54 for Universitites
and Other Non-Profits, and 40 CFR Part 31.45 for States, tribal, and local
governments.
Managing Your Financial Assistance Agreement, U.S. EPA Office of Administration and
Resources Management, EPA202-B-94-001, May, 1994.
Region III Order 5361.5, Location Identification Policy and Responsibilities, U.S. EPA
Region III, Office of Policy & Management.
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Region III Quality Management Plan September, 1996
Appendix A Terms and Definitions Page A-1
APPENDIX A
TERMS AND DEFINITIONS
Acceptable Quality Level - a limit above which quality is considererd satisfactory and
below which it is not. In sampling inspection, the maximum percentage of defects or
failures that can be considered satisfactory as an average.
Activity - an all-inclusive term describing a specific set of operations or related tasks to
be performed/either serially or in parallel (e.g., research and development, field sampling,
analytical operations, equipment fabrication), that in total result in a product or service.
Assessment - the evaluation process used to measure the performance or effectiveness
of a system and its elements. In this document, assessment is an all-inclusive term used
to denote any of the following: audit, performance evaluation, management systems
review, peer review, inspection or surveillance.
Audit - a planned and documented investigative evaluation of an item or process to
determine the adequacy and effectiveness, as well as compliance with established
procedures, instructions, drawings, QAPPs, and other applicable documents.
Characteristic - any property or attribute of a datum, item, process, or service that is
distinct, describable, and measurable.
Computer Program - a sequence of instructions suitable for processing by a computer.
Processing may include the use of an assembler, a compiler, an interpreter, or a translator
to prepare the program for execution. A computer program may be stored on magnetic
media, and be referred to as "software", or may be stored permanently on computer chips,
and be referred to as "firmware". Computer programs covered by this document are those
used for design analysis, data acquisition, data reduction, data storage (data bases),
operation or control, and data base or document control registers when used as the
controlled source of quality information.
Contractor - any organization or individual that contracts to furnish services or items or
perform work.
Corrective Action - measures taken to rectify conditions adverse to quality and, where
necessary, to preclude their recurrence.
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Region III Quality Management Plan September, 1996
Appendix A Terms and Definitions Page A-2
Customer - any individual or organization for whom items or services are furnished or
work performed in response to defined requirements and expectations.
Data Quality Assessment (DQA) - a process for performing statistical analysis to
determine whether the quality of a data set is adequate for its intended use.
Data Quality Objectives (DQOs) - qualitative and quantitative statements of the overall
level of uncertainty that a decision-maker is willing to accept in results or decisions derived
from environmental data. DQOs provide the statistical framework for planning and
managing environmental data operations consistent with the data user's needs.
Data Usability - the process of ensuring or determining whether the quality of the data
produced meets the intended use of the data.
Design Review- a documented evaluation by a team, including personnel other than the
original designers, the responsible designers, the customer for the work or product being
designed, and a QA representative to determine if a proposed design will meet the
established design criteria and perform as expected when implemented.
Engineered Environmental Systems - an all-inclusive term used to describe pollution
control devices and systems, waste treatment processes and storage facilities, and site
remediation technologies and their components that may be utilized to remove pollutants
or contaminants from the environment. Examples include wet scrubbers (air), soil washing
(soil), granulated activated carbon unit (water), and filtration (air, water). Usually, this term
will apply to hardware-based systems; however, it will also apply to methods or techniques
used for pollutant reduction or containment of contamination to prevent further movement
of the contaminants, such as capping, solidification or vitrification, and biological
treatment.
Environmental Conditions - the description of a physical medium (e.g., air, water, soil,
sediment) or biological system expressed in terms of its physical, chemical or biological
characteristics.
Environmental Data - any information or measurements resulting from field data collection
activity, laboratory analyses or modelling involving the assessment of chemical, physical
or biological factors related to the environment, and that describe environmental processes
or conditions,'or the performance of engineered environmental systems.
Environmental Data Operations - work performed to obtain, use, or report information
pertaining to environmental processes and conditions.
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Region III Quality Management Plan September, 1996
Appendix A Terms and Definitions Page A-3
Environmental Monitoring - the process of measuring or collecting environmental data.
Environmental Processes - manufactured or natural processes that produce discharges
to or impact the ambient environment.
Environmental Programs - an all-inclusive term pertaining to any work or activities
involving the environment, including but not limited to: characterization of environmental
processes and conditions; environmental monitoring; environmental research and
development; the design, construction, and operation of engineered environmental
systems; and laboratory operations on environmental samples. In this document, also
refers to functional areas of work performed by groups or teams of people within the
organization.
Environmentally Related Measurements - the data collection or analyses activity or
investigation involving the assessment of chemical, physical or biological factors in the
environment which affect human health or the quality of life.
Extramural - Relating to activities performed for EPA but not by EPA employees, usually
by contracts, grants or cooperative agreements. Used in reference to QAPPs and QMPs.
Financial Assistance - the process by which funds are provided by one organization
(usually government) to another organization for the purpose of performing work or
furnishing services or items. Financial assistance mechanisms include grants, cooperative
agreements, and government interagency agreements.
Graded Approach - the process of basing the level of application of managerial controls
applied to an item or work according to the intended use of results and the degree of
confidence needed in the quality of the results.
Hazardous Waste - any waste materials that satisfies the definition of "hazardous waste"
as given in 40 CFR Part 261, "Identification and Listing of Hazardous Waste".
Independent Assessment - an assessment performed by a qualified individual, group,
or organization that is not a part of the organization directly performing and accountable
for the work being assessed.
Inspection - examination or measurement of an item or activity to verify conformance to
specific requirements.
Intramural - Term used to describe activities performed by EPA employees, usually used
in relationship to QAPPs, QMPs, contracts or grants.
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Region III Quality Management Plan September, 1996
Appendix A Terms and Definitions Page A-4
Item - an all-inclusive term used in place of the following: appurtenance, facility, sample
assembly, component, equipment, material, module, part, product, structure, subassembly,
subsystem, system, unit, documented concepts, or data.
Management - those individuals directly responsible and accountable for planning,
implementing, and assessing work.
Management System - a structured non-technical system describing the policies,
objectives, principles, organizational authority, responsibilities, accountability, and
implementation plan of an organization for conducting work and producing items and
services.
Management System Review (MSR) - the qualitative assessment of a data collection
operation and/or organization(s) to establish whether the prevailing quality management
structure, policies, practices, and procedures are adequate for ensuring that the type and
quality of data needed are obtained.
Method - a body of procedures and techniques for performing an activity (e.g., sampling,
chemical analysis, quantification) systematically presented in the order in which they are
to be executed.
Mixed Waste - hazardous waste material, as defined by 40 CFR part 261 (RCRA), mixed
with radioactive constituents.
Peer Review - a documented critical review of work generally beyond the state of the art
or characterized by the existence of potential uncertainty. The peer review is conducted
by qualified individuals (or organization) who are independent of those who performed the
work, but are collectively equivalent in technical expertise (i.e., peers) to those who
performed the original work. The peer review is conducted to ensure that activities are
technically adequate, competently performed, . properly documented, and satisfy
established technical and quality requirements. The peer review is an in-depth
assessment of the assumptions, calculations, extrapolations, alternate interpretations,
methodology, acceptance criteria, and conclusions pertaining to specific work and of the
documentation that supports them. Peer reviews provide an evaluation of a subject where
quantitative methods of analysis or measures of success are unavailable or undefined,
such as in research and development.
Performance Evaluation (PE) - a type of audit in which the quantitative data generated
in a measurement system are obtained independently and compared with routinely
obtained data to evaluate the proficiency of an analyst or laboratory.
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Region III Quality Management Plan September, 1996
Appendix A Terms and Definitions Page A-5
Procedure - a documented set of steps or actions that systematically specifies or
describes how an activity is to be performed.
Process - an orderly system of actions that are intended to achieve a desired end or
result. Examples of processes include analysis, design, data collection, operation,
fabrication, and calculation.
QTRAK - is a computer program that contains database information on Quality
Management Plans and Quality Assurance Project Plans for the Program Managers,
Project Officers, and the QA Team for planning and assessment of the status of Regional
quality documents.
Qualified Data - any data that have been modified or adjusted as part of statistical or
mathematical evaluation, data validation, or data verification operations.
Quality - the sum of features and properties/characteristics of a process, item, or service
that bears on its ability to meet the stated needs and expectations of the user.
Quality Assurance (QA) - an integrated system of management activities involving
planning, implementation, assessment, reporting, and quality improvement to ensure that
a process, item, or service is of the type and quality needed and expected by the
customer.
Quality Assurance Council - an interdivisional organization with representatives from all
major Region III Divisions and Offices which provides a forum for discussion of
Quality Assurance activities and issues within Region 3, and provides advice to the senior
managers and the Quality Assurance Team.
Quality Assurance Division (QAD) - the EPA Headquarters office within the Office of
Research and Development that establishes and promulgates Quality Assurance Policy
for the Agency. Formerly the Quality Assurance Management Staff (QAMS).
Quality Assurance Manager (QAM) - the designated Region III lead for oversight of the
Regional QA Program. Also serves as Team Leader of the QA Team located within the
Office of Analytical Services and Quality Assurance (OASQA).
r
Quality Assurance Officer (QAO) - serves as the senior technical QA expert for the
Region and assists with a variety of QA functions, including performance evaluations for
drinking water laboratories and review of QAPPs.
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Region III Quality Management Plan September, 1996
Appendix A Terms and Definitions Page A-6
Quality Assurance Project Plan (QAPP) - a formal document describing in
comprehensive detail the necessary QA, QC, and other managerial and technical activities
that must be implemented to ensure that the results of the work performed will satisfy the
stated performance (data quality) objectives.
Quality Assurance Team (QA Team) - the designated Region III team whose function
consists exclusively of QA that comprise the directed work team led by the Region 3 QA
Manager. The QA Team reports to the Director of the Office of Analytical Services and
Quality Assurance.
Quality Control (QC) - the overall system of technical activities that measures the
attributes and performance of a process, item, or service against defined standards to
verify that they meet the stated requirements established by the customer.
Quality Improvement - a management program for improving the quality of operations.
Such management programs generally entail a formal mechanism for encouraging worker
recommendations with timely management evaluation and feedback or implementation.
Quality Indicators - measurable attributes of the attainment of the necessary quality for
a particular environmental decision. Indicators of quality include precision, bias,
completeness, representativeness, reproducibility, comparability, and statistical
confidence.
Quality Management - that aspect of the overall management system of the organization
that determines and implements the quality policy. Quality management includes strategic
planning, allocation of resources, and other systematic activities (e.g., planning,
implementation, and assessment) pertaining to the quality system.
Quality Management Plan (QMP) - a formal document that describes the quality system
in terms of the organizational structure, functional responsibilities of management and
staff, lines of authority, and required interfaces for those planning, implementing, and
assessing all QA activities conducted.
Quality System - a structured and documented management system describing the
policies, objectives, principles, organizational authority, responsibilities, accountability, and
implementation plan of an organization for ensuring quality in its work processes, products
(items), and services. The quality system provides the framework for planning,
implementing, and assessing work performed by the organization and for carrying out
required QA and QC procedures.
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Region III Quality Management Plan September, 1996
Appendix A Terms and Definitions Page A-7
Readiness Review - a systematic, documented review of the readiness for the startup or
continued use of a facility, process, or activity. Readiness reviews are typically conducted
before proceeding beyond project milestones and prior to initiation of a major phase of
work.
Remediation - the process of reducing the concentration of a contaminant (or
contaminants)'in air, water, or soil media to a level that poses an acceptable risk to human
health. .
Self-Assessment - Assessments of work conducting by individuals, groups, or
organizations directly responsible for overseeing and/or performing the work.
Service - the category of economic activity that does not produce manufactured items. In
environmental data operations or engineering projects, such activities include design,
inspection, laboratory and/or field analysis, repair, and installation.
Significant Condition - any state, status, incident, or situation of an environmental
process or condition of an engineered environmental system in which the work being
performed will be adversely affected in a manner sufficiently serious to require corrective
action to satisfy quality objectives or specifications and safety requirements.
Software Life Cycle - the period of time that starts when a software product is conceived
and ends when the software product is no longer available for routine use. The software
life cycle typically includes a requirements phase, a design phase, an implementation
phase, a test phase, an installation and check-out phase, an operation and maintenance
phase, and sometimes a retirement phase.
Standard Operating Procedure (SOP) - a written document that details the method for
an operation, analysis, or action with thoroughly prescribed techniques and steps, and that
is officially approved as trie method for performing certain routine or repetitive tasks.
Supplier- any individual or organization furnishing items or services or performing work
according to a procurement document or financial assistance agreement. This is an all-
inclusive term used in place of any of the following: vendor, seller, contractor,
subcontractor, fabricator, or consultant.
Surveillance - the act of monitoring or observing a process or activity to verify
conformance to specified requirements.
Technical Review - a documented critical review of work that has been performed within.
the state of the art. The review is accomplished by one or more qualified reviewers who
are independent of those who performed the work, but are collectively equivalent in
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Region III Quality Management Plan September, 1996
Appendix A Terms and Definitions Page A-8
technical expertise to those who performed the original work. The reviews are an in-depth
analysis and evaluation of documents, activities, material, data, or items that require
technical verification or validation for applicability, correctness, adequacy, completeness,
and assurance that established requirements are satisfied.
Technical Systems Audit (TSA) - a thorough, systematic, on-site qualitative audit of
facilities, equipment, personnel, training procedures, record keeping, data validation, data
management, and reporting aspects of a system.
Validation - an activity that demonstrates or confirms that a process, item, data set, or
service satisfies the requirements defined by the user.
Verification - the act of authenticating or formally asserting the truth that a process, item,
data set, or service is, in fact, that which is claimed.
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Region III Quality Management Plan September, 1996
Appendix B - EPA Order 5360.1 ' Page B-1
APPENDIX B
EPA Order 5360.1
Policy and Program Requirements to Implement the
Mandatory Quality Assurance Program
Aprils, 1984
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