US Environmental Protection Agency
Region III: Mid-Atlantic States
\ ** * 165° Arch street
Philadelphia, Pennsylvania 19103-2029
QUALITY
MANAGEMENT
PLAN
October 2008
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% UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
§ ^?f^7 I WASHINGTON, D.C. 20460
OCT 1 2008
OFFICE OF
ENVIRONMENTAL INFORMATION
MEMORANDUM
SUBJECT: Review of the Quality Management Plan for EPA Region 3
FROM: Reggie Cheatham, Director /
Quality Staff (2811R)
TO: Donald S. Welsh, Regional Administrator
Region 3
Thank you very much for the prompt response to our comments on Region 3's
revised Quality Management Plan (QMP), which were sent to your Quality Assurance
Manager, Terry Simpson, on July 1, 2008. It is clear that Region 3 has made significant
improvements with the latest revised QMP.
I am pleased to approve this QMP so that Region 3 can proceed with its timely
implementation. The QMP is the foundation of a Quality Management System as it
describes and documents quality management practices, authorities, and responsibilities
of EPA organizations; the application of quality assurance and quality control practices to
projects; sustainment of staff proficiency in quality; the planning, implementation, and
assessment of work; and the processes for improvement to organizations' quality
assurance procedures and practices.
We commend Region 3 for taking actions to continue to improve its Quality
Management System. The approval of this QMP is valid for up to five years unless there
are changes due to the implementation of the new Agency Quality Policy, a major change
in the Region 3 organization or mission, or the findings of a future assessment of your
Quality Management System.
Should you have any questions, please contact me at (202) 564-6830 or
Gary Johnson of my staff at (919) 541-7612.
cc: Terry Simpson, Quality Assurance Manager, Region 3
James W. Newsom, Assistant Regional Administrator for Policy and Management
Tai-Ming Chang, Senior Management Representative to the Regional Quality
Council
Gary Johnson, Quality Staff/RTF (N276-01)
Ron Shafer, Quality Staff (2811R)
Connie Thoma, Quality Staff (2811R)
Internet Address (URL) http://www.epa.gov
Recycled/Recyclable Printed with Vegetable Oil Based Inks on 100% Postconsumer, Process Chlorine Free Recycled Paper
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EPA Region III Quality Management Plan
September 2008
EPA REGION III QUALITY MANAGEMENT PLAN
CONCURRENCE
NAME Terry Simpson
TITLE Regional Quality Asg^ranqe^Manager
SIGNATURE
NAME Tai-Ming Chang
TITLE Senior Managerfieht Representative to the Regional Quality Council
SIGNATURE
Assistant RegionarAdrcfiniitrator for Policy and Management
-
NAME /Judith Katz
TITLE Director,
SIGNATURE
NAME Jeffrey Laf
TITLE Director, Chesape^ce Bay Program Office
SIGNATURE
NAME John "Randy" Pomponio
TITLE Director, Inrviroiimeljtal A'ss^ssrnent an4 Innovation Division
SIGNATURE 1//U IL^
NAME
TITLE
SIGNATURE
of EHfarce,jz^nt, Compliance and Environmental Justice
NAME V_Jsrnes J. Burke
TITLE Director, Hazardous Site Cleanup Division
SIGNATURE
NAME Abraham Ferdas
TITLE Director, Landed
SIGNATURE
NAME Jon Capacasa
TITLE Director, Fates Protection Qivifion
SIGNATURE
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EPA Region III Quality Management Plan
September 2008
EPA REGION III QUALITY MANAGEMENT PLAN
NAME Thomas M. Damm
TITLE Directo@ffife^CPublic Affairs
SIGNATURE
NAME Catherine A. Libertz
TITLE Director, Office of State and Congressional Relations
SIGNATURE '
NAME William
TITLE Regio:
SIGNATURE
APPROVAL FOR REGION III
NAME
TITLE
SIGNATURE
Donald S. Welsh
Regnal Administrat
NAME William T. Wisniewski
TITLE Depaty Regional ^dmifijstrator
SIGNATURE
APPROVAL FOR AGENCY
NAME Reggie Cheatham
TITLE Director, Quality Staff, Office of Environmental Information
SIGNATURE
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EPA Region III Quality Management Plan October 2008
TABLE OF CONTENTS
SECTION A: QUALITY SYSTEM FOUNDATION 1
A.I INTRODUCTION 1
A.I.a. Mission, Policy and Scope 1
A.l.b. Programs Covered by the Region III Quality System 2
A.l.b.l. Air Protection Division 2
A.l.b.2. Chesapeake Bay Program Office 3
A.l.b.3. Environmental Assessment and Innovation Division 3
A.l.b.4. Hazardous Site Cleanup Division 3
A.l.b.5. Land and Chemicals Division 3
A.l.b.6. Office of Enforcement, Compliance and Environmental Justice 4
A.l.b.7. Water Protection Division 4
A.l.b. 8. Office of Policy and Management 4
A.l.b.9. Office of State and Congressional Relations 4
A.l.b. 10. Delegated Programs 4
A.2. REGION III ORGANIZATION STRUCTURE 5
A.3. QUALITY SYSTEM ROLES AND RESPONSIBILITIES 6
A.3.a. Regional Administrator and Senior Leadership 7
A.3.b. Program Managers 7
A.3.c. Project Managers /Project Officers 8
A.3.d. Regional Quality Council 9
A.3.e. Senior Management Representative to the Regional Quality Council 10
A.3.f. Regional Quality Assurance Manager 10
A.3.g. Regional Quality Assurance Officer 10
A.3.h. Information Quality Guidelines Officer 11
A.3.L Quality Assurance Coordinators 11
A.3.J. Technical Services Branch 12
A.3.k. OASQA Laboratory Technical Director 12
A.3.1. OASQA Laboratory Quality Assurance Officer 13
A.4. COMMUNICATION 13
A.5. DISPUTE RESOLUTION 13
A.6. RESOURCES FOR THE REGION III QUALITY SYSTEM 13
A.7. PRINCIPAL COMPONENTS OF THE QUALITY SYSTEM 14
A.8. QUALITY MANAGEMENT PLANS 14
A.S.a. Region III Quality Management Plan 14
A.S.b. Division/Program Office Quality Management Plans 15
A.S.c. Quality Management Plans for Extramural Projects 15
A.9. LABORATORY QUALITY MANUALS 17
A.9.a. Office of Analytical Services and Quality Assurance 17
SECTIONB: PLANNING 18
B.I. REGION-WIDE PLANNING 18
B.I.a. Internal Strategic Planning 18
B.l.b. External Data Coordination 18
B.2. PROGRAM-SPECIFIC PLANNING 18
B.3. PROJECT-LEVEL PLANNING 19
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EPA Region III Quality Management Plan October 2008
B.3.b. Quality Assurance Project Plans 20
B.3.c. Generic or Program Quality Assurance Project Plans 21
B.3.d. Secondary Use of Environmental Information or Data 22
B.4. INFORMATION QUALITY GUIDELINES 23
B.4.a. Implementation Policy and Procedures 23
B.4.b. Requests for Correction 23
B.4.c. Requests for Reconsideration 23
B.4.d. Pre-Dissemination Review 24
SECTION C: IMPLEMENTATION OF WORK PROCESSES 25
C.I. PROGRAM IMPLEMENTATION 25
C.2. PROJECT IMPLEMENTATION 26
C.2.a. Quality Assurance Project Plans 26
C.2.b. Standard Operating Procedures 26
C.2.c. Inspection and Oversight of Facilities and Work Processes 27
SECTIOND: EVALUATION 29
D.I. ASSESSMENT TOOLS 29
D.I.a. Dispute Resolution 30
D.2. QUALITY SYSTEM ASSESSMENTS 30
D.2.a. Internal Quality System Assessments 30
D.2.b. Independent External Assessments 31
D.3. TECHNICAL SYSTEMS AUDITS 32
D.4. LABORATORY AUDITS 33
D.4.a. National Pollution Discharge Elimination System 33
D.4.b. Safe Drinking Water Act 33
D.4.c. Laboratories Used by Potentially Responsible Parties 34
D.4.d. Contract Laboratory Program 34
D.4.e. Other Analytical Services 35
D.4.f. National Environmental Laboratory Accreditation Program 35
D.5. PROFICIENCY TESTING SAMPLES 35
D.6. DATA VERIFICATION & VALIDATION 36
D.7 DAT A QUALITY ASSESSMENT 37
D.8. PEER REVIEW 37
D.9. QUALITY IMPROVEMENT 37
SECTIONE: INFRASTRUCTURE 39
E.I. QUALIFICATIONS AND TRAINING 39
E.I.a. Region III QA Training Program 39
E.l.b. Courses 39
E.l.c. Logistics 40
E.l.d. Documentation of Training 41
E.l.e. Training Requirements 41
E.2. PROCUREMENT AND FINANCIAL ASSISTANCE 43
E.2.a. Procurement- Contracts 43
E.2.a.l. Small Purchases 44
E.2.a.2. Procurement of Analytical Services 44
E.2.b. Financial Assistance 45
E.2.b.l. Grants and Cooperative Agreements 45
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EPA Region III Quality Management Plan October 2008
E.2.b.2. Inter-Agency Agreements 46
E.2.c. Evaluation of Deliverables 47
E.3. DOCUMENTATION AND RECORDS MANAGEMENT 47
E.3.a. Ensuring Documents and Records Accurately Reflect Completed Work 49
E.4. COMPUTER HARDWARE AND SOFTWARE 49
E.4.a. Roles and Responsibilities 49
E.4.b. Region III Information Management Systems 50
E.4.c. Data Standards 50
LIST OF FIGURES
Figure 1: EPA Region III Organization Chart
Figure 2: EPA Region III Organization Chart: QA Functions
Figure 3: The Quality System PIE
Figure 4: EPA IQG Request for Correction Process
Figure 5: EPA IQG Request for Reconsideration Process
APPENDICES
A j- A Region III Quality Assurance Requirements for Grants and . 1
Appendix A: * . , v ,T , _ on A-l
Cooperative Agreements, November 7, 2000
Appendix B: QA Review Form for Contract Actions B-l
Appendix C: Region III QMP Checklist C-l
Appendix D: Region III QAPP Preparation Checklist D-l
Appendix E: EPA Region III IQG Pre-dissemination Review Document E-l
Appendix F: Region III QSA Checklist F-l
Appendix G: References G-l
GLOSSARY
A glossary, available on the EPA Quality System website, includes terms commonly used in the
context of EPA's Quality System. These definitions were adapted from EPA or other federal
publications; reprinted with permission from the American Society for Quality (ASQ); or
included at the suggestion of the EPA QA Community.
http://www.epa.gov/qualitv/glossary.htm
in
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EPA Region III Quality Management Plan
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LIST OF ACRONYMS
AA Accrediting Authorities
ADP Automated Data Processing
APD Air Protection Division
CAA Clean Air Act
CBPO Chesapeake Bay Program Office
CLP Contract Laboratory Program
COR Contracting Officer's Representative
DAI Data Audit Inspection
DAS Delivery of Analytical Services
DMRQA Discharge Monitoring Reports Quality Assurance
DQA Data Quality Assessment
EAID Environmental Assessment and Innovation Division
EPA Environmental Protection Agency
EPCRA Emergency Planning and Community Right to Know Act
FAR Federal Acquisition Regulations
FIRMR Federal Information Resources Management Regulations
GIS Geographic Information Systems
HSCD Hazardous Site Cleanup Division
IAG Interagency Agreement
ICMS Integrated Contract Management System
IQG Information Quality Guidelines
IQGO Information Quality Guidelines Officer
IRM Information Resources Management
ISB Information Services Branch
ISO Information Security Officer
LCM Laboratory Certification Manual
NARA National Archives and Records Administration
NELAC National Environmental Laboratory Accreditation Conference
NELAP National Environmental Laboratory Accreditation Program
NPDES National Pollution Discharge Elimination System
OASQA Office of Analytical Services and Quality Assurance
OECEJ Office of Enforcement, Compliance and Environmental Justice
OEI Office of Environmental Information
OIRM Office of Information Resource Management
OPM Office of Policy and Management
ORC Office of Regional Counsel
PADEP Pennsylvania Department of Environmental Protection
PDR Pre-dissemination Review
PRP Potentially Responsible Parties
P/T Proficiency Testing
QA Quality Assurance
QAARWP Quality Assurance Annual Report and Work Plan
QAC Quality Assurance Coordinator
QAO Quality Assurance Officer
QAPP Quality Assurance Proj ect Plan
IV
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EPA Region III Quality Management Plan
October 2008
QC
QMP
QAS
QSA
RCRA
RFC
RFR
RQAM
RQAO
RQC
SARA
SAP
SDWA
SOP
TD
TMDL
TSA
TSCA
WAM
LCD
WPD
Quality Control
Quality Management Plan
Quality Assurance Staff
Quality System Assessment
Resource Conservation and Recovery Act
Request for Correction
Request for Reconsideration
Regional Quality Assurance Manager
Regional Quality Assurance Officer
Regional Quality Council
Superfund Amendments and Reauthorization Act
Sampling and Analysis Plan
Safe Drinking Water Act
Standard Operating Procedure
Technical Director
Total Maximum Daily Load
Technical Systems Audit
Toxic Substances Control Act
Work Assignment Manager
Land and Chemicals Division
Water Protection Division
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VI
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EPA Region III Quality Management Plan
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SECTION A: QUALITY SYSTEM FOUNDATION
A.1 INTRODUCTION
A.l.a. Mission, Policy and Scope
Environmental information or data is defined as
any measurements or information that describe
environmental processes, location, or conditions;
ecological or health effects and consequences; or the
performance of environmental technology. For EPA
Region III, environmental information also includes
data produced from models, and compiled from
other sources such as data bases or literature.
EPA's overarching
mission is to protect human
health and the environment.
To accomplish this mission,
EPA utilizes environmental
information from a variety of
sources. The Region III
Quality Management Plan
(QMP) describes the policies,
procedures and management
systems within the
organization that govern
quality control activities of
environmental information collection and/or use. Activities involving environmental
information and/or data that are covered by the Region III Quality System include, but are not
limited to:
Characterize and/or evaluate the states and/or conditions of environmental or
ecological systems and the health of human populations;
Characterize and/or evaluate chemical, biological, physical, or radioactive
constituents in environmental and ecological systems, and their behavior and
associated interfaces in those systems, including exposure assessment, transport, and
fate;
Establish the ambient conditions in air, water, sediments, soil, etc. in terms of
physical, chemical, radiological, or biological characteristics;
Determine and/or categorize radioactive, hazardous, toxic, and mixed wastes in the
environment and to establish their relationships with and/or impact on human health
and ecological systems;
Quantify and/or monitor the waste and effluent discharges to the environment from
processes and operations (e.g., energy generation, metallurgical processes, chemicals
production), during either normal or upset conditions (i.e., operating conditions that
cause pollutant or contaminant discharges);
Develop and/or evaluate environmental technology for waste treatment, storage,
remediation, and disposal; pollution prevention; and pollution control and the use of
the technology to generate and/or collect data (e.g., treatability and pilot studies);
Map environmental processes and conditions, and/or human health risk data, etc.
(e.g., geographic information system);
Support enforcement and/or compliance monitoring efforts;
Develop or evaluate methods for use in the collection, analysis, and use of
environmental data;
Develop, evaluate and/or use models to characterize environmental processes or
conditions; and
1
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EPA Region III Quality Management Plan October 2008
Develop, revise, compare, or otherwise use information technology and management
systems that impact the environmental data quality (e.g., electronic databases with
environmental information including data entry, handling, transmission and analysis
and laboratory information management systems);
The primary goal of the Region's quality system is to ensure that all environmentally-
related data activities performed by or for the Region will result in the production of data that is
of adequate quality to support specific decisions or actions. In order for this data to be used with
a high degree of certainty by the intended user, its quality must be known and documented. This
goal will be achieved by ensuring that appropriate resources are made available and proper
procedures followed throughout each environmental project's planning, implementation and
evaluation phase.
Region III Quality Policy
It is Region III policy that all environmental data and information collected
and/or used in the process of decision-making are of known and documented
quality, suitable for its intended use, with all aspects of collection and analysis
thoroughly documented; such documentation being verifiable and defensible.
This policy applies to all data collected under environmental operations and
environmental technology activities performed directly by or for the Region.
This includes all Federal, State, Tribal and local partners under inter agency
and financial assistance agreements; contractors funded by EPA; regulated
entities and potentially responsible parties.
The Regional Administrator, Senior Leadership and managers ensure that
adequate resources (intramural and extramural money, travel and training
funds, and personnel) are allocated to achieve the Region's quality policy.
This QMP establishes the foundation for implementing an effective quality system within
EPA Region III. The QMP applies to all Region III programs, activities, grants, contracts and
interagency agreements that collect and/or evaluate environmental data which is used to make
decisions or support actions related to our defined mission and responsibilities. Listed below are
specific examples of environmental programs, grants and activities within each Division or
Program Office which are covered by the Region III Quality System.
A.l.b. Programs Covered by the Region III Quality System
A. l.b.l. Air Protection Division
Clean Air Act
Ambient air quality data (monitoring by states via 105 grants)
Ambient air monitoring - per 40 CFR Part 58
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)
CAA compliance inspections
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EPA Region III Quality Management Plan October 2008
A.l.b.2. Chesapeake Bay Program Office
Mainstem and Tidal Tributary Monitoring Programs
Baywide SAV Aerial Survey Program
Non-tidal Monitoring Program
A.l.b.3. Environmental Assessment and Innovation Division
Laboratory analyses - performed at Ft Meade and Wheeling labs
Ocean Dumping Program
Fish tissue surveys
Dredging
Coastal Aerial Survey Program
Coastal waters sampling
Wetland grants
NEPA
Environmental planning / environmental indicator development
Geospatial analysis
Laboratory assessments (CLP, Regional contract laboratories, NPDES laboratory
assessments of State and regulated laboratories, Superfund PRP laboratories, State
drinking water laboratories)
A.l.b.4. Hazardous Site Cleanup Division
CERCLA and the Superfund Amendments and Reauthorization Act of 1986 (SARA)
SARA Title III Chemical Emergency Preparedness and Prevention (CEPP) program.
Regional Oil Program pursuant to the Oil Pollution Act (OPA) of 1990
A.l.b.5. Land and Chemicals Division
Asbestos
CAA - NESHAPS
Asbestos enforcement
Asbestos hazard in schools (AHERA)
Asbestos Hazard Abatement Act (ASHAA)
Asbestos enforcement grants
FIFRA
Pesticide cooperative agreement grants
Pesticide environmental stewardship grants
RCRA
Corrective action
RCRA compliance and enforcement
RCRA Subtitle C grants
RCRA Subtitle I grants
Deli sting
TSCA
TSCA 404(g) lead grants
PCB enforcement
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EPA Region III Quality Management Plan October 2008
Other TSCA lead grants
A.l.b.6. Office of Enforcement Compliance and Environmental Justice
Compliance inspections (media specific and multi-media)
Sample collection
Facility inspections that support RCRA (Subtitle C and I, NPDES, pretreatment,
TSCA/PCB, EPCRA/TRI reporting and asbestos
A.l.b.7. 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
Source Water Protection Program
Clean Water Act
National Pollutant Discharge Elimination System (NPDES) Program
Water Quality Management Planning (Section 604(b)) Grants Program
Water Pollution Control (Surface/Groundwater Programs) (Section 106) Grants
Program
Targeted Watershed Initiative
Non-point Source (Section 319) Grants Program
Clean Lakes Program
State Revolving Fund Program
Water Quality Standards Program
Nutrient Criteria Program
Total Maximum Daily Load (TMDL) Program
Great Lakes Program
Ambient water monitoring (routine monitoring performed mostly through the
states)
National Estuary Program
Beaches
Watershed Protection Program
Water Quality Management (106) Grants Program
A.l.b.8. Office of Policy and Management
Regional Geographic Initiative Grant Program
A.l.b.9. Office of Public Affairs
Environmental Education Grant Program
A. 1 .b. 10.Delegated Programs
The following programs have been delegated to some or all of the Region III Middle
Atlantic States - Delaware, District of Columbia, Maryland, Pennsylvania, Virginia, and West
Virginia:
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EPA Region III Quality Management Plan October 2008
RCRA Subtitle C (hazardous waste)
RCRA Subtitle I (underground storage tanks)
Air - Clean Air Act Title I permits, Title V permits, and most of Title III air toxics
Public Water Supply (except District of Columbia)
Underground Injection Control (except the District of Columbia and
Pennsylvania)
Pesticides
National Pollutant Discharge Elimination System (except the District of
Columbia)
Pretreatment (except the District of Columbia, Delaware and Pennsylvania)
There are no delegations for the Sludge, Oil Pollution Act, Wetlands, Water Quality
Standards, or Chlorofluorocarbons (CFCs) programs. The Total Maximum Daily Load (TMDL)
program is not an officially delegated program; however, the states have primary responsibility.
The Region's quality assurance (QA) responsibilities in relation to these delegated programs are
oversight through mid-year program reviews, end of the year program reviews, and approval of
QMPs and QAPPs. Program-specific oversight responsibilities are documented in respective
Division/Program Office QMPs.
A.2. REGION III ORGANIZATION STRUCTURE
EPA Region III employs a 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. Division/Program Office QA requirements may
be more, but not less stringent than those presented in this QMP and are documented in
respective Quality Management Plans.
The Region is comprised of five Divisions and six Program Offices. The program-
specific Divisions are the Air Protection Division (APD), Environmental Assessment and
Innovation Division (EAID), Hazardous Site Cleanup Division (HSCD), Land and Chemicals
Division (LCD) and the Water Protection Division (WPD). The six Offices are the Chesapeake
Bay Program Office (CBPO), Office of Enforcement, Compliance and Environmental Justice
(OECEJ), Office of Regional Counsel (ORC), Office of Public Affairs, Office of State and
Congressional Relations and the Office of Policy and Management (OPM). A copy of the
Region's organization chart can be found in Figure 1.
At this time, the ORC, OP A, and OSCR do not perform or manage environmental data
operations and; consequently, do not maintain QMPs. Occasionally, OPM administratively
manages (i.e., competition, funding, ensuring completion of deliverables) discretionary funded
grants involving environmental data operations. However, a technical representative is always
also assigned to assist in the management of such grants. These grants will adhere to the
respective Division/Program Office QA requirements and those specified in this QMP, as
applicable.
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EPA Region III Quality Management Plan
October 2008
All individuals in the Region
who are directly or indirectly
involved with environmental
data operations have some
responsibility for ensuring data
quality.
A.3. QUALITY SYSTEM ROLES AND RESPONSIBILITIES
In accordance with EPA Order 5360.1 A2 (CIO Directive 2105.0), overall
responsibility for the quality assurance program in
Region III rests with the Regional
Administrator. The responsibility for
developing and documenting Regional QA
policies, procedures and guidance; overseeing the
implementation and assessment of the Regional
quality system; and providing QA training has
been delegated to the Regional Quality Assurance
Manager. The Regional Quality Assurance Manager (RQAM) is located in the Immediate
Office of the EAID Division Director and is independent of direct environmental data operations.
On issues relative to the Region's quality system, the RQAM reports to the Senior Management
Representative to the Regional Quality Council (RQC or Council) and is afforded access to the
Regional Administrator / Deputy Regional Administrator, if needed. The mission of the Council
is to oversee implementation and ensure the continuous effectiveness of the Region III Quality
Management Plan and strives to create an environment where an awareness of quality is the
norm. Each Division and Program Office that collects and/or evaluates environmental data
assigns a Quality Assurance Coordinator to the Council (see Table A. 1 for a list of current
members). The structure and function of the RQC allows each level of the organization to
participate in maintaining and improving the Region's Quality System. An organization chart
which shows the reporting relationships for Region III QA personnel can be found in Figure 2.
Table A.I. Regional Quality Council Membership
Division/Office or
Responsibility
Sr. Mgmt Representative
Regional QA Manager
APD
CBPO
EAID
OASQA/QA Staff (EAID)
IQG Officer (EAID)
HSCD
LCD
OECEJ
OPM
WPD
Representative
Alternate Rep
Tai-Ming Chang
Terry Simpson
Chris Pilla
Rich Batiuk
Mary Ellen Ley
Charlie Jones
Mary Ellen Schultz
John Graves
Jeff Turtle
David Friedman
Jose Jimenez
Norman Rodriguez
Larry Merrill
Mail
Code
3EAOO
3EAOO
3 API 2
3CB10
3CB10
3EAOO
3EA20
3EA10
3HS41
3LC10
3ECOO
3PM60
3WP30
Phone
(215)814-2761
(410) 305-2739
(215) 814-3438
(410)267-5731
(410)267-5750
(215)814-2734
(410) 305-2746
(215)814-5710
(215)814-3236
(215)814-3395
(215)814-2148
(215)814-5274
(215)814-5452
Email
Chang .tai-ming@epa.gov
Simpson.terry@epa.gov
Pilla.chris@epa.gov
Batiuk.richard@epa.gov
Lev.marv(2),epa.eov
Jones.charlie@epa.gov
Schultz.maryellen@epa.gov
Graves.john@epa.gov
Turtle j effrey @epa. gov
Friedman.davidm@epa.gov
Jimenez.jose@epa.gov
Rodriguez.norman@epa.gov
Merrill . larry@epa. gov
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EPA Region III Quality Management Plan October 2008
A.S.a. Regional Administrator and Senior Leadership
The Regional Administrator (RA), Deputy RA, and Senior Managers (Division
Directors/Office Directors) have overall responsibility for the Regional QA Program as
described in EPA Order 5360.1 A2 (CIO Directive 2105.0), available at
http://www.epa.gov/irmpoli8/ciopolicy/2105-0.pdf. Specifically, the RA, DRA and Senior
Managers are responsible for ensuring that:
All Regional components and programs comply fully with the requirements of EPA
Order 5360.1 A2 (CIO Directive 2105.0);
Quality program management is an identified activity with associated resources
adequate to accomplish its program goals and is implemented as prescribed in the
Region III QMP;
QMPs covering Division or Program Office environmental data operations are
developed, updated and effectively implemented;
All environmental data operations are covered by the appropriate documentation (i.e.,
Quality Assurance Project Plans, Sampling and Analysis Plans, Standard Operating
Procedures, etc.);
All environmental data operations implemented through extramural agreements
comply fully with applicable QA/QC requirements;
Training in the fundamental concepts and practices of quality management is available
for state, local, and tribal governments performing environmental data operations for
EPA;
Internal quality assessments are performed to ensure that programs comply with QA
requirements. Deficiencies highlighted in the assessments are appropriately addressed;
Agency policy and guidance are applied in identifying work products subject to peer
review, determining the type and timing of such review, and documenting the process
and outcome of each peer review;
Performance Agreements for supervisors, senior managers, and appropriate staff
contain performance measures that are commensurate with their assigned quality
management responsibilities;
Each Division or Program Office which collects, evaluates and/or uses environmental
data is represented on the Regional Quality Council by a Quality Assurance
Coordinator; and
Disputes regarding quality system requirements, QA/QC procedures, assessments or
corrective actions are resolved.
A.S.b. Program Managers
Program Managers may be Branch Chiefs, Section Chiefs or Team Leaders and are
the stewards of environmental data in Region III. EPA staff involved with environmental data
operations performed under financial assistance agreements, contracts, and extramural non-
supported measurement are responsible for incorporating QA requirements into grant conditions;
contracts; and voluntary, consensual or unilateral enforcement agreements, decrees and orders.
Program Managers have technical expertise in a specific program area (e.g., TMDL, permits,
enforcement, etc.) and serve as the focal lead for a specific environmental program. In this role,
they must ensure that:
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EPA Region III Quality Management Plan October 2008
All intramural and extramural projects within their program that involve environmental
data operations are performed in accordance with the Regional and Divisional QMPs
and an approved QAPP;
Resources required to implement Program QA requirements are identified and
provided;
Adequate procedures are in place to address QA requirements in all applicable program
operations, including those delegated to state agencies;
All environmental data operations are covered by the appropriate documentation (i.e.,
Quality Assurance Project Plans, Sampling and Analysis Plans, Standard Operating
Procedures, etc.);
Internal quality assessments are performed to ensure that programs comply with QA
requirements. Deficiencies highlighted in the assessments are appropriately addressed;
Agency policy and guidance are applied in identifying work products subject to peer
review, determining the type and timing of such review, and documenting the process
and outcome of each peer review;
Performance Agreements for supervisors, team leaders, and appropriate staff contain
performance measures that are commensurate with their assigned quality management
responsibilities;
The Division or Program Office cooperates with QA reviews or audits and submits
requested information in a timely manner;
Appropriate corrective action recommended by audit findings is implemented;
QA concerns with the Division/Office QA Coordinator and/or RQAM are discussed;
Disputes regarding quality system requirements, QA/QC procedures, assessments or
corrective actions are resolved;
QA training needs for his/her specific environmental program are identified and
reported to the QA Coordinator; and
Pre-dissemination review for an information product will be planned and implemented
at the start of each applicable project.
A.S.c. Project Managers / Project Officers
Project Officers (POs), Project
Managers, Site Assessment Managers
(SAMs), Remedial Project Managers (RPMs),
On-Scene Coordinators (OSCs) and Work
Assignment Managers (WAMs) are assigned
For the purposes of this document, Region
III uses the terms Project Manager,
Project Officer (Technical &
Administrative), Site Assessment Manager,
Remedial Project Manager, On-Scene
responsibility for specific projects supported Coordinator and Work Assignment
1 V A ^1 1 A ^ A- Manager interchangeably.
by EPA through contracts, cooperative
agreements, grants or interagency agreements
(lAGs). Since POs and WAMs may not be
closely familiar with QA procedures, they are
encouraged to work with their Divisional/Program Office QA Coordinator to ensure that QA
requirements are addressed.
The specific responsibilities of Project Managers/Project Officers are to ensure that:
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EPA Region III Quality Management Plan October 2008
All extramural projects which generate and/or compile environmentally related data,
adhere to QA requirements found in Agency, Regional and Divisional policy and/or
QMPs;
All grant and TAG recipients or contractors conducting projects which involve
environmental data operations submit a QMP, which documents their quality system,
as appropriate. If applicable, the QMP must be submitted to the EPA Project Officer at
least 45 days prior to the initiation of environmental data operations per the Region III
Quality Assurance Requirements for Grants and Cooperative Agreements, November
7, 2000 (Appendix A) and Section B.3.b of this QMP;
All grant and TAG recipients or contractors conducting a project which involves
environmental data operations have an approved QAPP prior to initiating any data
generation, compilation and/or use per the Region III Quality Assurance Requirements
for Grants and Cooperative Agreements, November 7, 2000 (Appendix A) and Section
B.S.bofthisQMP;
For contracts, the Region III Quality Assurance Review Form for Contract Actions
(Appendix B) is completed, and approved in writing by the RQAM (or designee) and
Project Officer (see Section E.2 for a description of specific procedures);
For grants and assistance agreements, the funding recommendation form in IGMS is
completed to indicate whether QA requirements apply;
Data from environmental programs delegated to state and local governments are of
sufficient quantity and adequate quality for their intended use and are used consistent
with such intentions;
Agency policy and guidance are applied in identifying work products subject to peer
review, determining the type and timing of such review, and documenting the process
and outcome of each peer review;
Determine whether an information product will be disseminated and ensure that a pre-
dissemination review is completed; and
Plan for dissemination of the information at the start of the project.
A.S.d. Regional Quality Council
The Regional Quality Council (RQC) oversees the Regional Quality System and ensures
the effective implementation of practices and policies defined by the Regional Quality
Management Plan. The RQC consists of a Senior Management Representative, RQAM,
Regional Quality Assurance Officer and a QA Coordinator from each Division or Program
Offices conducting environmental data operations. The primary responsibilities of the RQC are
to:
Review and update the Region's QMP;
Develop & oversee implementation of Regional QA policies and procedures;
Develop QA training and Quality System Assessment plans for the Region;
Review and implement quality system assessment recommendations;
Establish QA priorities for each new fiscal year; and
Resolve disputes regarding quality system requirements, QA/QC procedures,
assessments or corrective actions.
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EPA Region III Quality Management Plan October 2008
A.S.e. Senior Management Representative to the Regional Quality Council
The Senior Management Representative to the RQC serves as a liaison between the
Senior Managers and the RQC. The Regional Administrator shall appoint the Senior
Management Representative to the RQC. Specifically, the Senior Management Representative:
Provides Senior Managers with periodic updates on the status of the Region's Quality
System;
Provides the RQC with periodic updates from the Senior Managers about issues that
impact the Region's Quality System; and
Resolves disputes regarding quality system requirements, QA/QC procedures,
assessments or corrective actions.
A.S.f. Regional Quality Assurance Manager
The Regional Quality Assurance Manager (RQAM) has been delegated primary
responsibility for the oversight of the Regional Quality System. Specifically, the RQAM is
responsible for:
Facilitating the development of the Region's QMP and preparing updates to the
approved QMP;
Representing the Region at national quality meetings, such as the RQAM monthly
conference call, national QA conferences, etc. Also, serves as primary Regional liaison
with the Quality Staff in EPA Headquarters and Region III State QA contacts;
Providing expert assistance to Regional staff on QA/QC policies, requirements, and
procedures applicable to procurement, financial assistance and technical
activities/services;
Reviewing and approving QMPs submitted by Region III Divisions and Offices and by
holders of extramural agreements;
Performing periodic assessments of Regional organizations conducting environmental
data operations to determine the conformance of their mandatory quality systems to
their approved QMPs and the effectiveness of their implementation;
Coordinating and submitting the Annual QA Report and Workplan to Senior Regional
Managers and the Office of Environmental Information (OEI) Quality staff;
Authorizing organizations (i.e., states and local governments) to review and approve
QAPPs;
Providing, scheduling and/or notifying Regional staff of QA training and briefings;
Distributing Agency QA guidance documents, policies, and procedures;
Initiating and/or revising Regional QA policy & procedures; and
Facilitating the discussion of disputes regarding quality system requirements, QA/QC
procedures, assessments and/or corrective actions.
A.S.g. Regional Quality Assurance Officer
The Regional Quality Assurance Officer (RQAO) serves as a technical QA expert and
liaison to the Quality Assurance Coordinators within the Region. As liaison, the RQAO is
expected to keep program QACs informed of activities and test results. In the RQAM's
absence, the RQAO serves as the Region's liaison with the Quality Staff in EPA Headquarters.
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EPA Region III Quality Management Plan October 2008
The RQAO's primary responsibilities are to:
Serve as QA Coordinator for EAID (see duties under A.3.L);
Facilitate the development of EAID's QMP and preparing updates to the approved
plan;
Provide technical assistance to Regional staff on QA/QC policies, requirements, and
procedures applicable to procurement, financial assistance and technical
activities/services;
Review QAPPs submitted by holders of extramural agreements financed by EAID;
Provide, schedule and/or notify Regional staff of QA training and briefings;
Review and certify drinking water laboratories;
Administer the SDWA and NPDES Proficiency Testing (P/T) studies;
Participate in assessments of Regional and State QA programs to assure that they
adhere to their approved QMPs; and
Serve as Discharge Monitoring Report Quality Assurance (DMRQA) Evaluation Study
Coordinator.
A.S.h. Information Quality Guidelines Officer
The Information Quality Guidelines Officer (IQGO) is located in EAID Office of
Environmental Information and Analysis. The IQGO serves as a Regional coordinator for
Information Quality Guidelines activities. The IQGO coordinates IQG activities with the
RQAM and the Region's Product Review officer. Specific responsibilities are as follows:
Provide technical assistance to Regional staff on IQG policies, requirements, and
procedures;
Serve as point of contact on IQG procedures;
Help implement IQG pre-dissemination review procedures in the Region;
Facilitate communication on IQG policies and procedures within the Region and with
HQ Quality Staff; and
Coordinate responses from Region III information owners to requests for correction
and requests for reconsideration with HQ Quality Staff
A.S.i. Quality Assurance Coordinators
Each Division and Program Office conducting environmental data operations shall
have a Quality Assurance Coordinator (QAC). QACs are responsible for coordinating the
implementation of the quality system within their Division or Program Office. The QAC:
Disseminates QA information to Division or Program Office staff;
Conducts QA briefings for Division or Program Office Directors;
Participates in RQC meetings;
Facilitates preparation and/or revision of his/her Division or Program Office's QMP;
Helps implement the Division or Program Office's QMP;
Helps Project Managers and/or Project Officers resolve data quality issues with
contractors and financial assistance recipients;
Reviews and/or approves program/project QAPPs and SOPs (according to the policies
and procedures described in the Division or Program Office QMP);
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EPA Region III Quality Management Plan October 2008
Assesses Division or Program Office's QA-related training needs and arranges the
delivery of training;
Provides assistance to Project Managers/Project Officers with completion of QA
Review Forms for acquisitions/contracts/work assignments;
Reviews and signs QA Review Forms for acquisitions/contracts/work assignments;
Assists Project Managers/ Project Officers with completion of QA-related questions on
the funding recommendation form in IGMS for grants, cooperative agreements, and
interagency agreements;
Tracks the number of projects in progress within his/her Division or Program Office;
the number of projects involving environmental data operations; and the title, preparer
and date of QAPPs received, reviewed and approved;
Provides reports on above to RQAM at a frequency to be determined by the RQC (at
least annually);
Consolidates Division or Program Office's QA information for the QA Annual Report
and Work Plan and delivers it to the RQAM; and
Participates in and/or conducts assessments of Divisional or Program Office and state
QA programs to assure that they adhere to their approved QMPs.
A.S.j. Technical Services Branch
The Technical Services Branch is comprised of the Regional Sample Brokerage and
Quality Assurance (QA) Staff. It is organizationally placed in EAID Office of Analytical
Services and Quality Assurance (OASQA) and geographically located in Fort Meade, MD. The
Branch serves as the focal point for procurement of analytical services for environmental data
operations and providing quality assurance support to Divisions and Program Offices in Region
III. The branch's primary responsibilities include:
Determining the most cost-effective means for acquiring environmental sample
analyses;
Procuring and/or scheduling sample analysis through national or regional contracts;
Evaluating and assessing environmental data for contract compliance;
Conducting laboratory inspections for the Superfund Contract Laboratory Program
(CLP), and other contract laboratories;
Assisting with environmental project planning;
Reviewing QAPPs, SAPs, and other QA documentation;
Assisting the RQAM with review of external Quality Management Plans;
Providing technical assistance on QA/QC policies, requirements, and procedures
applicable to technical activities;
Participating in assessments of QA and QC activities;
Working with the RQAM to develop Regional QA policy & guidance documents; and
Providing, scheduling and/or notifying Regional staff of QA training courses.
A.S.k. OASQA Laboratory Technical Director
The OASQA Laboratory Technical Director (TD) monitors lab technical
operations and conformance to OASQA quality system components at the laboratory.
Specific duties are detailed in the current version of the EPA Region III OASQA
Laboratory Quality Manual.
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EPA Region III Quality Management Plan October 2008
A.3.1. OASQA Laboratory Quality Assurance Officer
The OASQA Laboratory QAO is responsible for the design and management of
OASQA's laboratory quality system. Specific responsibilities are detailed in the current
version of the EPA Region III OASQA Laboratory Quality Manual.
A.4. COMMUNICATION
This QMP will be distributed to all individuals responsible for implementing the
policies and procedures found in this document. Several mechanisms will be used to distribute
QA information. On a regular basis, the RQAM will keep the EAID Director, Senior
Management Representative, RQAO, RQC and senior managers apprised of QA issues that
impact the Region's quality system. In addition, new QA developments, policies, and
procedures will be distributed to all Division and Program Offices and posted on the
internet/intranet sites, as applicable. The Region III QMP will be posted on the Region's
internet/intranet site(s) and/or shared directories of the Region's Local Area Network, as
applicable. When the Region III QMP is revised, the new version will be posted and older
versions archived. Organizational QMPs and project-specific QAPPs will be posted on the
Region's internet/intranet site, as applicable.
The RQC, as the primary cross-Divisional group for addressing QA topics that impact the
entire Region, meets quarterly to discuss and resolve issues about QMP implementation and its
impact on data quality. The RQC also discusses ways to improve the Region's Quality System.
Communication of an Agency-wide nature, takes place among the RQAM, the OASQA QA
Staff, other RQAMs and Headquarters during monthly teleconferences.
A.5. DISPUTE RESOLUTION
In order to resolve disputes related to quality assurance, the Region will strive to resolve
the issue at the lowest administrative level practicable. The dispute resolution process shall
begin when either disagreeing party declares an issue to be irresolvable and sends written
correspondence to the other party defining the disputed issue, and presenting supporting
arguments for the first party's position on the issue. All parties shall make every effort to
resolve disputes through discussion and negotiation. Should agreement not be reached at this
level, the issue will be directed to the Divisional QAC. If the issue is not resolved, it will be
directed to the RQAM. If necessary, the RQAM will work to resolve the problem with the
Senior Management Representative to the RQC and ultimately the RA/DRA. The resolving
officials will document the resolution and provide it to the disputing parties.
A.6. RESOURCES FOR THE REGION III QUALITY SYSTEM
The level of QA resources needed for an environmental program or project is determined
by the relevant Regional program. Since an assigned national program element for QA does not
exist, most resources needed for QA are taken from a variety of program elements which utilize
QA functions and services. Each Division or Office Director shall ensure that there are adequate
resources to successfully implement QA requirements for their environmental programs.
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EPA Region III Quality Management Plan
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A.7. PRINCIPAL COMPONENTS OF THE QUALITY SYSTEM
The Region III Quality System consists of the people, functions, tools and procedures
used to ensure that data of known quality and sufficient quantity is generated for Regional data
users and decision makers. Successful implementation of the Region III Quality System requires
a consistent and graded approach for QA practices commensurate with the intended use of the
data. A variety of tools and procedures are employed for planning, implementing and evaluating
the Region's Quality System. Managers and staff members are informed of the availability and
use of these tools through their Divisional QACs.
The principal components of the Region Ill's Quality System exist at the program-
and project-level. A list of these components is provided below:
Program-level
Quality Management Plans
Laboratory Quality Manuals
Quality Assurance Annual Report and Work Plan
Quality Systems Assessments
Training Plans
Information Quality Guidelines
Quality Management Plan Status Reports
Newly Awarded Grants Reports
Project-level
Data Quality Objectives
Quality Assurance Project Plans
Standard Operating Procedures
Technical System Audits
Proficiency Testing Samples
Data Quality Assessments
Pre-dissemination Reviews
Assessment Factors
kfl
A.8. QUALITY MANAGEMENT PLANS
A.S.a. Region III Quality Management Plan
The Region III QMP complies with the
requirements found in the EPA Quality Manual,
EPA Order 5360 Al (CIO Procedure 2105-P-01-0),
May 5, 2000 and Policy and Program
Requirements for the Mandatory Agency-wide
Quality System, EPA Order 5360.1A2 (CIO
Directive 2105.0), May 5, 2000. This document
serves as the "umbrella" document for all Regional
programs and describes the quality system in terms
of organizational structures, functional
responsibilities of management and staff, lines of
authority, and required interfaces for those
planning, implementing, and evaluating activities
conducted.
The QMP is developed by the RQAM with assistance from the Regional Quality Council
and the OASQA QA Staff and is intended to be used by all Regional staff. This QMP shall be
reviewed and approved by all Division and Program Office Directors and the Regional
The Region III QMP contains the
policies and procedures being
implemented to ensure that
environmental data generated,
collected, compiled, analyzed,
and/or utilized by and for the
Region are of adequate quality
for its intended use.
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EPA Region III Quality Management Plan October 2008
Administrator. Final approval of the Region III QMP shall be granted by the Director of the
EPA Office of Environmental Information (OEI) Quality Staff. The approval is valid for up to
five years; however, pursuant to EPA Order 5360.1A2 (CIO Directive 2105.0), updates or
revisions to the QMP are required as a result of organizational and/or Regional policy/process
changes, or findings from quality system assessments. The Region III QMP shall be reviewed
for such changes and updated, as necessary, on an annual basis.
A.S.b. Division/Program Office Quality Management Plans
Each Region III Division and Program Office that conducts environmental data
operations shall develop and maintain its own QMP. This QMP shall describe the organization's
QA management policies, objectives, and internal procedures. These documents shall be
consistent with the requirements found in the most recent version of the EPA Quality Manual
5360A1 (CIO Procedure 2105-P-01) and EPA Order 5360.1A2 (CIO Directive 2105.0).
Division and Program Office QMP requirements may be more, but not less, stringent than those
presented in the Region III QMP. All Division/Program Office's QMPs require approval by
Division/Program Office management and the RQAM, or designee.
The most recent version of the Region III QMP Checklist (Appendix C) may be used to
review these QMPs. Approval of the Division/Program Office QMP is valid for a period up to
five years and is subject to review and revision by the Quality Assurance Coordinator annually.
Minor organizational and/or policy changes shall be documented in the Division/Program Office
QA Annual Report and Work Plan. When there are substantial organizational or policy changes
that impact a Division or Program's quality system, the Division/Program Office QMP shall be
updated and resubmitted to the RQAM for review and approval.
A.S.c. Quality Management Plans for Extramural Projects
Likewise, financial assistance
recipients' quality policies and practices
shall be documented in a QMP, or
equivalent document, in accordance with
the most recent version of EPA
Requirements for Quality Management
Plans, EPA QA/R-2, March 2001,
available at
http://www.epa.gov/qualitv/qs-docs/r2-
final.pdf. Should there be multiple
programs involved in a grant, cooperative
agreement, IAG or contract, the recipient
may submit a single QMP covering all of the programs in the grant, cooperative agreement,
IAG or contract or a separate QMP for each program receiving such funds, per the Region III
Quality Assurance Requirements for Grants and Cooperative Agreements, November 7, 2000
(Appendix A).
The recipient's QMP shall be approved internally by its Quality Assurance Manager, or
equivalent and the organization's senior management. Financial assistance recipients at all
levels, must submit their QMP or combined QMP/QAPP to the EPA Project Officer/Project
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Region III Policy
Recipients of Region III financial assistance
(i.e., grants, cooperative agreements, contracts
and inter agency agreements) that involve the
generation, collection, compilation and/or use of
environmental data must develop and implement
QA policies and practices that are sufficient to
produce data of adequate quality to meet
program objectives.
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EPA Region III Quality Management Plan October 2008
Manager at least 45 days prior to the initiation of environmental data operations, per the Region
III Quality Assurance Requirements for Grants and Cooperative Agreements, November 7, 2000
(Appendix A). The QMP or combined QMP/QAPP shall be forwarded to the RQAM, or
designee, for review. The most recent version of the Region III QMP Review Checklist
(Appendix C) may be used to facilitate the review. When applicable, the Region III QACs will
be asked to facilitate the QMPs' review by conducting a review of the technical activities and
programs documented in QMPs for extramural organizations being funded by their Division or
Program Office. The QMP or combined QMP/QAPP must be approved by the RQAM prior to
the conduct of environmental data operations. EPA approval is valid up to five years. The
recipient shall review its QMP annually and report minor organizational and/or policy changes in
its annual report to the Agency, as applicable. When there are substantial organizational and/or
policy changes that impact the recipient's quality system, the recipient shall update and resubmit
its QMP to the RQAM for review and approval.
For smaller or single program/project organizations there may be situations when a single
document is more applicable. By applying a graded approach to these situations, the RQAM
and/or Division/Program Office QACs may identify more appropriate quality system
documentation required from the organization receiving financial assistance. Each situation will
be determined on a case-by-case basis by the RQAM and/or Division/Program Office QAC, as
applicable. In general, organizations receiving financial assistance may be granted an exception
or modification to the QMP requirement if they meet criteria which may include, but not be
limited to, the following:
small grants as defined by the EPA Small Grants Policy,
one-time, short-term, and special projects or projects of limited scope; and
organizations generating, collecting, compiling and/or using environmental data for
public education purposes.
Upon receipt of a QMP or combined QMP/QAPP, the RQAM shall update the Region
III QMP Status Report. This report contains the name of the organization that submitted the
QMP, the receipt date, the review status and the approval status. The QMP approval shall be
formally documented in a letter to the financial assistance recipient, a memorandum to the
Project Manager/Officer, and/or both. The status of a QMP may be:
Approved: The Quality Management Plan adheres to requirements found in EPA
Requirements for Quality Management Plan, EPA QA/R-2. QMP is
valid for five years from date of approval.
Conditional: The cursory review of this document indicates that the grantee has
documented the basic components of a quality system. However,
minor revisions to the grantee's QMP are required to ensure
conformance to EPA Requirements for Quality Management Plans,
EPA QA/R-2. Conditional approval allows grantees to perform
activities that include the generation and/or use of environmental data
while making revisions to finalize their plan.
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EPA Region III Quality Management Plan October 2008
Resubmit: The Quality Management Plan is in need of significant revision in order
to meet the basic components of a quality system. The
grantee/contractor is required to ensure conformance to EPA
Requirements for Quality Management Plans, EPA QA/R-2 prior to
performing activities that include the generation and/or use of
environmental data.
Expired: The Quality Management Plan on file with EPA Region III is no longer
current and needs to be revised and resubmitted for review.
In Progress: The Quality Management Plan has been received by EPA Region III
and is undergoing review.
Each month, the updated Region III QMP Status Report shall be posted on the Regions'
intranet site and distributed to the Region III Division/Program Office QACs; the Office of
Policy and Management (OPM's) Grants and Audit Management Branch; and OPM's Contracts
Branch. The Grants and Audit Management Branch and Contracts Branch shall distribute the
updated QMP Status Reports to all Region III Project Officers. Region III Project Officers
shall use this information to ensure that extramural agreement holders under their purview have
fulfilled their EPA QA requirements.
A.9. LABORATORY QUALITY MANUALS
A.9.a. Office of Analytical Services and Quality Assurance
The EAID Office of Analytical Services and Quality Assurance (OASQA) Quality
System is based on the requirements of ISO 17025 General Requirements for the Competency
of Testing and Calibration Laboratories, and the National Environmental Laboratory
Accreditation Program (NELAP) Chapters 2 and 5. Analytical services provided by OASQA
are documented in the most recent version of the OASQA Laboratory Quality Manual. This
manual describes the laboratory's quality system policies and procedures. The Laboratory's
Quality System is NELAP accredited by the State of New Jersey Department of Environmental
Protection (NJDEP), an approved Accrediting Body. Each person involved in the laboratory's
operations shall be familiar with OASQA's quality system and the technical requirements of the
tests being conducted. The OASQA Laboratory Quality Manual and a list of SOPs are available
upon request from the OASQA Director.
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EPA Region III Quality Management Plan
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SECTION B: PLANNING
Figure 3. The Quality System PIE
The acronym PIE is used to describe Region Ill's
Quality System components. "P" stands for planning; "I"
for implementation; and "E" for evaluation. Planning is
described here, in Section B. Implementation is described
in Section C and Evaluation in Section D.
A major goal of Region Ill's Quality System is to
promote effective planning for the collection, analysis and
processing of environmental information and/or 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.
B.I. REGION-WIDE PLANNING
B.l.a. Internal Strategic Planning
The Region III Strategic Plan is the foundation for all programmatic priorities and
environmental data operations. Using the projected annual budget for the Region, and guidance
from the various program offices in EPA Headquarters, the Regional Administrator and the
Senior Leadership meet early in the fiscal year to set Regional priorities. The Regional
Administrator and Senior Leadership rely in part on Logic Models developed for all Region III
programs having 10 or more FTE's to set conceptual priorities. The setting of priorities for
programs within Region III is evaluated using tools such as the Multi-criteria Integrated
Resource Assessment (MIRA) application. Region III recognizes the Logic Model and MIRA
processes as systematic planning. These priorities are then reflected in the Regional Strategic
Plan, which establishes program goals, resource utilization plans and budget allocations. Annual
action plans developed by the individual Divisions and Offices, tied to the Strategic Plan and
budget distribution process, further specify the types of environmental data operations that will
occur and the corresponding requirements for QA and QC procedures.
B.l.b. External Data Coordination
Region III also coordinates environmental data operations with numerous government
agencies, academic and private organizations. Close coordination and planning is essential to
ensure that data are of sufficient quality to support the intended uses and can also be shared
with other organizations. The Region encourages data sharing wherever possible and supports
the data quality planning to make that possible.
B.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 (e.g., the Volunteer Monitoring Program).
All Regional environmental data operations conducted in support of these programs are covered
by this QMP, though not all require the same level of QA. When initiating a new program or
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EPA Region III Quality Management Plan October 2008
incorporating major statutory changes, the program shall establish the minimum quality system
components required to achieve program compliance.
For many ongoing environmental monitoring programs, the National Program Offices at
EPA Headquarters have established standard QA/QC requirements. These QA/QC requirements
may be documented in a generic Program QMP, QAPP or SOP. In these cases, the Region shall
defer to these national program documents. Any modifications or deviations from these
documents shall be documented.
B.3. PROJECT-LEVEL PLANNING
B.S.a. Systematic Planning Process
Region III Policy
A systematic planning process shall be
used for all environmental data operations
conducted by or on behalf of Region III.
The systematic planning process is a
mechanism for balancing conflicting demands
and data quality needs to ensure that
environmental data operations will effectively
support decision-making. EPA's Guidance on
Systematic Planning Using the Data Quality
Objectives Process, EPA QA/G-4, February
2006, available at http://www.epa.gov/quality/qs-docs/g4-fmal.pdf describes one such process
but any other systematic planning process may be used as long as it is based on the scientific
method and complies with Chapter 3 of the EPA Quality Manual, 5360 Al (CIO Procedure
2105-P-01).
Elements of a systematic planning approach shall include:
S Identification and involvement of the Project Manager/Project Officer, sponsoring
organization and responsible official, project personnel, stakeholders, scientific
experts, etc. (i.e., all customers and suppliers);
S Description of the project goal, objectives and questions/issues to be addressed;
-S Identification of project schedule, budget, milestones, and any applicable
requirements (e.g., regulatory requirements, contractual requirements);
S Identification of the type of data needed and how the data will be used to support
the project's objectives;
-S Determination of the quantity of data needed and specification of the performance
criteria for measuring quality;
S Description of how, when, and where the data will be obtained including existing
data and identification of any constraints on data collection;
S Specification of needed QA and QC activities to assess the quality performance
criteria (e.g., QC samples for both the field and laboratory, audits, technical
assessments, performance evaluations, etc.);
S Description of how the acquired data will be analyzed (either in the field or the
laboratory), evaluated (i.e., QA review, validation, verification), and assessed
against its intended use and the quality performance criteria.
The Project Manager/Project Officer is responsible for ensuring that a systematic
planning process is used and documented and that all organizations and/or parties who contribute
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Region III Policy
All projects and tasks involving environmental
data operations that are conducted by or for
Region shall have an approved QAPP in place
prior to the start of data generation or use.
EPA Region III Quality Management Plan October 2008
to the quality of the environmental project or use the results are identified and participates in the
planning process. Guidance and technical support for using a systematic planning process are
available from the RQAM and OASQA Quality Staff, upon request.
B.S.b. Quality Assurance Project Plans
The systematic planning
process described above results in the
development of a sampling network
design, generation of appropriate data
quality indicators, selection of
measurement and analytical
methodologies, standard operating
procedures, etc. Region III policy
requires that the results of the systematic planning process be documented in a Quality
Assurance Project Plan (QAPP) and approved by authorized personnel prior to implementation.
The only exception to this requirement shall be for environmental projects that require
immediate action to protect human health and the environment or operations conducted under
police powers.
The Region has embraced the "graded approach" as defined in Section 2.4.2 of EPA
Requirements for Quality Assurance Project Plans for Environmental Data Operations, EPA
QA/R-5, March 2001, available at http://www.epa.gov/quality/qs-docs/r5-fmal.pdf The level of
detail found in the QAPP shall be commensurate with the nature of the work being performed
and the intended use of the data.
The QAPP shall be prepared in accordance with EPA Requirements for Quality Assurance
Project Plans for Environmental Data Operations, EPA QA/R-5, March 2001. EPA's Office of
Solid Waste and Emergency Response (OSWER) has issued OSWER Directive 9272.0-17,
available at http://www.epa.gov/swerffrr/pdf/oswer qapp directive.pdf stating that the Uniform
Federal Policy for Quality Assurance Project Plans (UFP-QAPP) is designated for use in Federal
facility projects where environmental data are collected (e.g., CERCLA, RCRA, Brownfields).
EPA Region III subscribes to this policy and strongly encourages the use of the UFP-QAPP for
Federal facility and other hazardous waste projects. QAPP requirements apply to all
environmental data operations conducted by Regional staff or through grants, cooperative
agreements, contracts, Interagency Agreements and compliance orders.
Project Managers/Project Officers shall ensure that QAPPs are developed and approved
for all projects under their authority. The decision to approve or reject a QAPP is based on the
Project Manager/Project Officer's technical expertise and the comments received from the
EAID QA Staff. To date, the RQAM has not delegated the review and approval of QAPPs to
any extramural agreement recipient.
The title(s) of the individual(s) responsible for the review of QAPPs shall be documented
in all Division/Program Office QMPs. All individuals' assigned responsibility for QAPP
reviews shall be knowledgeable of EPA QA/R-5 and/or UFP-QAPP and have completed the
Region's required training for QAPP reviewers. These individuals should also have
professional knowledge of chemical and biological principles, theories, practices and
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EPA Region III Quality Management Plan October 2008
established methods, statistical techniques commonly used in quality control, data assessments,
and data management practices. Extensive knowledge of the principles and practices of quality
assurance and the ability to adapt these applications to Agency programs is also required. The
Region III QAPP Preparation Checklist (Appendix D) developed by the OASQA Quality
Assurance Staff may be used for this review.
The QAPP approval shall be formally documented in accordance with procedures
specified in the approved Division or Program Office QMP. The status of a QAPP may
be:
Approved The document was found to address the key QA issues
satisfactorily.
Conditionally Approved The document satisfactorily addressed most of the key
elements; however, minor deficiencies were noted.
Sampling and analysis may begin while these minor
deficiencies are being resolved.
Resubmission Required The document was found to be deficient in describing the
key elements. Further clarification of specific issues is
required. Modification to specific procedures that may
influence data quality should be accomplished prior to
approval of the plan and initiation of the data collection
activity.
Once all critical issues have been addressed, the Project Manager/Project Officer shall
indicate QAPP approval via signature or approval memorandum; ensure it is implemented as
written; and include a copy in the project file. For continuous projects, the QAPP must be
reviewed annually by the authoring organization. Annual review shall be documented in the
organization's annual report to EPA Region III. Additionally, the QAPP must be revised and
submitted to EPA for review every three to five years, based upon the original approval date, to
ensure that the documented procedures are still accurate. Revisions to the approved QAPP shall
be documented in a second or subsequent revision or an addendum. Sometimes the scope of a
project can change which may have the potential to affect the quality of the data. If these
changes are significant (as determined by the Project Manager/Project Officer) and affect the
scope and objectives of the project, data use, or data quality; the revised QAPP or addendum
must be reviewed and approved in the same manner as the original QAPP. The Project
Manager/Project Officer is responsible for ensuring all appropriate personnel receive a copy of
the revised QAPP or addendum once it is approved.
B.S.c. Generic or Program Quality Assurance Project Plans
For multiple projects or sites with the same objective(s) and/or environmental decision(s),
a Generic or Program QAPP may be desirable and appropriate. A Generic or Program QAPP
shall adhere to the QAPP requirements specified in Section B.3.b. The Generic or Program
QAPP shall include the elements which remain constant among the different projects or sites.
Most Generic or Program QAPPs will be supported by a site-specific or project-specific plan
which addresses the QA elements that are unique to each site or project. The Generic or
Program QAPP shall include the procedures being used for the preparation, review, and approval
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EPA Region III Quality Management Plan
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of the site-specific or project-specific plan. If the site-specific or project-specific plan contains
analytical and/or sampling procedures that are not found in the Generic or Program QAPP, the
site-specific or project-specific plan must be reviewed in accordance with the procedures
documented in the appropriate Division/Program Office QMP and Section B.3.b of this QMP.
The appropriateness of a Generic or Program QAPP is determined on case-by-case basis
by the Project Manager/Project Officer in cooperation with the RQAM, RQAO, QAC or
Quality Assurance Staff. The Project Manager/Project Officer shall ensure that the approved
Generic or Program QAPP is reviewed annually for changes to organization, policy, and/or
procedures and updated every three to five years. Any minor changes can be appended to the
original document. Substantial changes require that the document be resubmitted to EPA for
review and approval.
B.S.d. Secondary Use of Environmental Information or Data
Secondary use data is defined as data that is collected
for other purposes or from other sources, such as
literature, industry surveys, compilations from
computerized databases and the results from
computerized or mathematical models of environmental
processes and conditions.
Prior to its use,
environmental data
collected from secondary
sources shall be evaluated
to ensure a level of quality
that is commensurate with
its intended use(s). The
Project Manager/Project
Officer is responsible for
ensuring that such data
collection is addressed in a project-specific QAPP, if applicable. The project QAPP shall:
V Identify the types of data needed for project implementation or decision making;
V Describe the intended use of the data;
V Define the acceptance criteria for the use of data;
V Specify any limitations on the use of the data;
V Identify the individual(s) responsible for evaluating and qualifying the data.
For those projects which involve the compilation and use of environmental data from
secondary sources exclusively (i.e., there will be no direct environmental data generation
performed to accomplish the project), a project-specific QAPP is still required. Per the graded
approach, the level of detail for this QAPP will differ from that for a direct environmental data
generation project. Assistance with determining the appropriate elements for a QAPP for
projects involving secondary use data may be provided by the RQAM or the OASQA Quality
Assurance Staff, upon request. The Project Manager/Project Officer is responsible for ensuring
a QAPP is prepared for these types of environmental data projects.
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EPA Region III Quality Management Plan
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B.4. INFORMATION QUALITY GUIDELINES
"Information " generally includes any
communication or representation of
knowledge, position or policy such as
facts or data, in any medium, or form.
This includes "preliminary " information
endorsed or adopted by EPA, and also
conclusions or facts drawn from or based
upon other existing information.
The Guidelines for Ensuring and
Maximizing the Quality, Objectivity, Utility,
and Integrity of Information Disseminated
by the EPA, 260R-02-008, December 2002,
or more commonly known as the IQGs,
contain EPA's policy and procedural
guidance for ensuring and maximizing the
quality of information the Agency
disseminates and complements EPA's
Quality System for assuring the quality of
EPA's products and information. This QMP
incorporates by reference all definitions,
principles, policies, and procedures found in
EPA's IQGs
http://www.epa.gov/quality/informationguidelines/documents/EP A_InfoOualityGuidelines.pdf.
The Region will ensure that EPA disseminated information products are presented in an
accurate, clear, complete and unbiased manner. The Region will also ensure that the integrity of
EPA Region III web sites will be protected from unauthorized access or revision.
B.4.a. Implementation Policy and Procedures
In accordance with EPA's IQGs, Region III has established policies and procedures for
complying with these guidelines (Appendix E) with emphasis on using existing Regional
processes or procedures wherever possible. The Region III Information Quality Guidelines
Officer works with communications and web coordinators in each division when an information
product is proposed to be disseminated.
B.4.b. Requests for Correction
The IQGs allow for affected persons to request correction of information if that
information does not comply with EPA or Office of Management and Budget (OMB)
Information Quality Guidelines. The Office of Environmental Information (OEI) Quality Staff
will receive the requests for correction (RFC) and forward them to the Region III IQG Officer
when the information in question belongs to or involves Region III. The IQG Officer will then
work with the OEI Quality Staff and the information owner to formulate a response. A
schematic for the RFC process is attached as Figure 4.
B.4.c. Requests for Reconsideration
Affected persons may appeal EPA responses to RFC's under a formal Request for
Reconsideration (RFR). When an RFR is received for a Region III product, the IQG Officer will
work with the information owner and the OEI Quality Staff on the response. This process is
depicted in Figure 5.
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EPA Region III Quality Management Plan October 2008
B.4.d. Pre-Dissemination Review
The review process is intended to ensure the quality of products the Region disseminates.
Pre-dissemination review should begin at the planning stage for information products. Region
III programs may use one or more review processes to satisfy pre-dissemination review as
specified by EPA's Pre-dissemination Review Guidelines. Region III programs may also use the
EPA Region III Information Quality Guidelines Pre-Dissemination Review document which is
included as Appendix E. This document contains the Region's checklist for pre-dissemination of
information.
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EPA Region III Quality Management Plan
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SECTION C: IMPLEMENTA TION OF WORK PROCESSES
The implementation of the procedures
specified in this section shall ensure that all
environmental data operations being conducted within
the Region conform to the requirements found in this
QMP, the EPA Order 5360.1 A2 (CIO Directive
2105.0) and the EPA Quality Manual, 5360 Al.
These procedures are currently being implemented at
the program and project level.
C.I. PROGRAM IMPLEMENTATION
Figure 3. The Quality System PIE
Annually, the Region III QMP shall be reviewed by the RQC to ensure that the
documented QA policies and procedures are current and accurate. The Region III QMP shall
also be reviewed whenever there is a major reorganization or there are significant policy and/or
procedural changes that impact the Region's Quality System. In addition, every five years,
based upon the original approval date, the Region III QMP will undergo a more in-depth review.
If revisions are required, the RQC shall revise the QMP and distribute it to Senior Managers for
review and approval. After the QMP has been approved by the Regional Administrator, it shall
be delivered to the Director of the OEI Quality Staff for review and approval. Upon final
approval, a copy of the QMP will be filed with each Regional Division/Program Office via the
Region III intranet and/or shared directories on the Regional local area network and to external
organizations through the Region III home page. An e-mail announcement about the newly
approved Region III QMP shall be sent to all staff from the RQAM.
Similarly, each Division or Program Office QA Coordinator shall review his/her
organization's QMP. Minor changes to the QMP will be documented in the Division/Program
Office's annual report. Significant policy and/or procedural changes require revision to the QMP
and submission to the RQAM for approval. After the QMP has been approved, the QA
Coordinator shall distribute the newly revised QMP to managers and supervisors. Older versions
of Division/Program Office QMPs shall be removed from circulation.
Approved QMPs for extramural projects shall be updated every five years, or whenever
there are major organizational changes that impact the documented quality system. Extramural
agreement holders are required to review their QMP annually and report the outcome of the
review in their annual report. If revisions are required, the revised QMP shall be resubmitted to
EPA Region III for review and approval in accordance with the procedures specified in Section
A.S.c. The QMP Status Report is used to document the approval status of QMPs for extramural
projects.
Annually, the Region shall submit a Quality Assurance Annual Report and Work Plan
(QAARWP) to the Director of the OEI Quality Staff. The QA report will summarize the QA-
related resources, training, accomplishments (i.e., innovative practices, technical assessments,
QMP revisions, QA guidance, technical assistance, etc.) and quality system assessments/audits
that have been conducted in the previous fiscal year. The QAARWP will also include a list of
QA activities planned for the upcoming fiscal year. Each Division or Program Office that is a
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EPA Region III Quality Management Plan October 2008
part of the Region's Quality System shall provide its information to be compiled into a
Region-wide report. The QAARWP will be prepared according to Chapter 4 of the most
current version of the EPA Quality Manual, 5360 Al (CIO Procedure 2105-P-01) by the
RQAM with cooperation from the QA Coordinators and OASQA Quality Staff. The
QAARWP will also be used to identify minor changes or updates to Region Ill's QMP. The
QAARWP will be distributed to the RQC for concurrence. Prior to its distribution to the
Director of the EPA OEI Quality Staff, the report shall be reviewed and approved by the
Regional Administrator or his/her designee.
C.2. PROJECT IMPLEMENTATION
C.2.a. Quality Assurance Project Plans
Once final approval has been received, the Project Managers/Project Officers shall ensure
that all project personnel have a copy of the newly approved QAPP. The Project
Manager/Project Officer shall also ensure that obsolete versions of the QAPP are removed from
work areas. Verification of the changes to the QAPP shall be determined during a project's
technical system audit. The approved QAPP must be implemented as prescribed; however, the
QAPP may be modified and/or amended at any time to ensure project objectives are met.
Modifications and/or amendments to the QAPP must follow the appropriate submission and
approval procedures outlined in Section B of this QMP.
C.2.b. Standard Operating Procedures
The use of SOPs serves as a mechanism to ensure
comparability across programs and individual environmental
data operations. SOP use is encouraged as a means of Procedure (SOP) is a set
ensuring that routine or repetitive activities, processes or
procedures are performed consistently within acceptable that document a routine
A Standard Operating
of written instructions
or repetitive activity that
shall be followed.
timeframes and with acceptable quality. SOPs can describe
both technical and administrative operational elements.
SOPs will thoroughly describe steps and techniques, and will
be sufficiently clear to be understood by a person with
knowledge in the general concept of the procedure or
process. Any limitation on the use or applicability of a specific SOP will be documented in the
SOP itself.
The need for an SOP for a specific activity or operation can be identified by any staff
member in the Region, and can be written by any Regional staff member who is knowledgeable
of the activity, equipment, procedure, or process to be addressed. In general, the SOP is
implemented by staff that perform the activity, process or procedure to which the SOP pertains.
It is the responsibility of the individual users of an SOP to follow the procedures contained in the
SOP or to document any deviations. It is the responsibility of managers to ensure that specific
SOPs that pertain to their program operations are implemented. It is the responsibility of Project
Managers / Project Officers to ensure that SOPs referenced in specific QAPPs are implemented.
The implementation of QA-related SOPs is a responsibility of the QAC of the respective
Division/Office. Implementation of SOPs will be assessed through internal QSAs and TSAs.
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EPA Region III Quality Management Plan October 2008
The primary guidance document for the preparation of SOPs in Region III is entitled,
"Guidance for the Preparation of Standard Operating Procedure", EPA QA/G-6, April 2007,
available at http://www.epa.gov/quality/qs-docs/g6-fmal.pdf. All SOPs shall be reviewed and
approved by the manager of the organization within the respective Division/Office originating
the SOPs and by the Division/Office QAC or his/her designee. All SOPs will be reviewed every
3 years or periodically, as specified in the respective Division/Office QMP. Detailed
procedures/processes for SOP development, review, approval, revision and withdrawal are
further documented in each Division/Office QMP. The RQAM, or designee, shall ensure that
the procedures each organization conducting environmental data operations uses to develop,
review, approve and implement SOPs are found in its respective QMP.
C.2.c. Inspection and Oversight of Facilities and Work Processes
Compliance inspections occur at active municipal, industrial and/or federally owned
facilities. These inspections are primarily focused on making compliance determinations based
upon facility representative interviews, facility records and facility documents. However,
samples may be collected to help identify whether a potential violation exists.
The vast majority of sampling conducted during compliance inspections would be
considered "opportunistic" sampling. These sampling activities are not planned. The inspector
makes a decision to collect samples as a result of observations made during the course of the
inspection. If sampling is required, samples are collected in accordance with SOPs developed by
the Office of Enforcement, Compliance and Environmental Justice (OECEJ) Field Inspection
Program. For inspections being conducted to support criminal investigations, the Criminal
Investigation Division (CID) investigator in charge of the case manages the sampling activities.
CID investigators often rely on the technical expertise of the OECEJ field inspectors to help
determine where to sample and how many samples to collect.
OECEJ field personnel rarely conduct sampling in support of the Region III Superfund
program. However, when this type of sampling is required, OECEJ field personnel work closely
with the Project Manager/Project Officer to ensure that all of the necessary sampling objectives
are met. Prior to sampling, OECEJ field personnel familiarize themselves with the site's QAPP
and/or Sampling and Analysis Plan (SAP). To the extent practicable, OECEJ field personnel
ensure that their sampling activities are consistent with those specified in the site's approved
QAPP and/or SAP. Any deviations between OECEJ sampling procedures and those specified in
the sites approved QAPP and/or SAP are discussed with the Project Manager/Project Officer.
In addition to compliance related sampling, OECEJ field personnel routinely collect
samples to support ambient water quality monitoring projects, such as TMDL and water quality
standards investigations. For these types of sampling activities, the Region uses an approved
generic SAP developed by the Pennsylvania Department of Environmental Protection (PADEP)
for ambient water quality monitoring projects.
Samples collected for compliance and multi-media inspections are transported to the
OASQA Regional Laboratory. Occasionally, samples are shipped to a laboratory that is
secured by the Region's Sample Brokerage. Analytical data reports are sent to the OECEJ
inspector. The inspector shall be responsible for evaluating the analytical results and
submitting a written report to the appropriate Region III Division/Program Office. The written
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EPA Region III Quality Management Plan October 2008
report shall include the inspector's conclusions regarding the data and its regulatory
implication.
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EPA Region III Quality Management Plan
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SECTIOND: EVALUATION
The Region uses a variety of tools (i.e., quality
system audits, technical audits, etc.) to ensure that the
procedures documented in this QMP are being
implemented. These independent audits, reviews and
assessments evaluate the conformance of the Region's
Quality System with the procedures described in this
QMP.
Annually, the RQC will assess the adequacy of QA
., » ,. , resources and the level of expertise necessary to support
Figures. The Quality System PIE , . . , £ . , . y + -n
the various programs in the Region. This assessment will
evaluate the Region's environmental program activities to determine if the number and type of
QA resources are adequate. The assessment will also
evaluate the adequacy of intramural and extramural
funding to determine if adequate funding is provided for
QA-related activities. The results of this assessment will
be documented in the Region's Quality Assurance
Annual Report and Work Plan (QAARWP) described
earlier. Region III Senior Leadership is responsible for
making final decisions about the allocation of QA resources.
Region III uses the terms
audit, review, assess, and
evaluate interchangeably.
D.I. ASSESSMENT TOOLS
Selection of the appropriate assessment tool depends upon whether a quality system or
technical system is being assessed. Technical system assessment tools are also dependent upon
the stage of the project being assessed. The following table outlines the types of assessment
tools that may be used in Region III.
Quality System Assessments
Level Appropriate Tool
Assessment of Quality Quality System Assessment (QSA)
System
Comments
Assesses conformance to a
documented quality system through
collection of information and
documented evidence of
implementation.
Technical (Project-level) Assessments
Project Stage
Planning
Sampling
Analysis
Appropriate Tool
QA Project Plan Review;
Site Scoping Meeting and/or Visit
Technical Systems Audit
Technical Systems Audit
Example(s)
QAPP Review; Peer Review
Field Sampling Audit
Laboratory (Field or Fixed) Audit;
Proficiency Testing Sample
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EPA Region III Quality Management Plan
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Project Stage
Data
Evaluation/Assessment
Data Usability
Appropriate Tool
Data Audit
Data Quality Assessment
Example(s)
Data Audit Inspection; Data Verification
and Validation
Data Quality Assessment; Usability
Report; Peer Review
D.l.a. Dispute Resolution
If disputes are encountered as a result of evaluations, the dispute resolution process as
defined in Section A. 5 of this QMP shall apply.
D.2. QUALITY SYSTEM ASSESSMENTS
Each year, the RQAM and RQC shall evaluate the Region's conformance with the EPA
Order 5360.1A2 (CIO Policy 2105.0) and the EPA Quality Manual, 5360 Al (CIO Procedure
2105-P-01). Each October, the RQAM requests, compiles, and reviews information regarding
Regional quality resources and activities, including: 1) quality management resources; 2)
QA/QC training; 3) quality system-related accomplishments; and 4) assessments of quality and
technical systems. For any area found to need improvement, an action plan is developed and
incorporated in the QA Annual Report and Work Plan. The QAAWRP will summarize the
findings of each QSA conducted during the previous fiscal year. A summary of corrective
actions initiated as a result of these QSAs shall also be included. The RQC shall use these
reports to inform decisions on the QA priorities for the following year.
D.2.a. Internal Quality System Assessments
It is the goal of Regional Quality Council to conduct an internal QSA of at least one
division/office per year, and complete QSAs on all divisions/offices within a 3-year cycle. The
RQAM and RQC are responsible for regional-level QSAs of each division/office. The RQAM
shall be responsible for assembling the assessment team and coordinating activities. At a
minimum, the team shall consist of the RQAM (or designee) and at least one member of the
RQC. The team may also include a member of the OASQA Quality Assurance Staff and a
representative from outside the program being assessed. The audited Division or Program
Office's QA Coordinator shall assist the QSA Team in handling the logistics of the assessment
and scheduling interviews.
Upon completion of the assessment, the preliminary results of the regional-level QSA
shall be shared with the Division or Program Office's Senior Leadership during an exit briefing.
Approximately 60 days following the QSA, the assessment team shall submit a written draft
findings report documenting the results of the QSA to the Division or Program Office's Senior
Management. Findings may include noteworthy accomplishments and/or objective evidence of
non-conformance with the organization's quality system. The Division or Program Office shall
review the draft findings report to ensure it accurately describes the QA procedures being
implemented by their organization. The Division or Program Office shall then provide the
assessment team with formal comments on the draft findings report. If the QSA team concurs
with these comments, the findings report shall be revised and finalized. If concurrence with the
formal comments can not be achieved, dispute resolution specified in Section A.5 shall be used
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EPA Region III Quality Management Plan October 2008
to achieve consensus on the content of the final findings report. The assessment team shall
submit the final report to the Division or Program Office's Senior Management.
Upon receipt of the final findings report, the Division or Program Office shall prepare a
written corrective action plan and submit it to the RQC. The Corrective Action Plan must
identify the corrective action, responsible official(s), and the projected completion date for each
finding requiring corrective action. Upon acceptance by the RQC, implementation may begin.
The Division or Program Office's QA Coordinator and the RQC shall periodically review the
status of the Division or Program Office Corrective Action Plans.
All members of the assessment teams shall be familiar with the QA requirements found
in EPA Order 5360.1A2 (CIO Directive 2105.0) and this QMP. The individuals should also
have professional knowledge of chemical and biological principles, theories, practices and
established methods. Knowledge of the principles and practices of quality assurance and the
ability to adapt these applications to Agency programs is also desired.
Information found in EPA's Guidance on Assessing Quality Systems., QA/G-3, March
2003, available at http://www.epa.gov/quality/qs-docs/g3-fmal.pdf may be used in the
development of the QSA. A standard checklist, developed by the RQAM (Appendix F), is used
to help ensure that the appropriate QA requirements are evaluated during the QSA. During the
QSA, managers and active participants in the organization's quality system are interviewed.
Project files, previous audit reports and corrective action plans are also reviewed.
Likewise, it is the goal of each division/office to conduct a QSA of at least one program
element within its division/office per year. More frequent review may be needed if serious
deficiencies are detected. The respective division/office QAC and line managers are responsible
for the assessments of program elements within the respective division/office. Assessments
conducted at the division/office level follow similar procedures as discussed above, depending
upon the program element assessed, with one exception. The RQC is not typically involved in
the briefing, reporting, or corrective action processes. The RQC may be employed in the event
of disputes. Further details on the procedures for planning, conducting, documenting, and
reporting QSAs at the division/office level are documented in the QMP of each respective
division/office.
D.2.b. Independent External Assessments
Independent assessments are conducted by the OEI Quality Staff, the Office of Inspector
General, the Government Accountability Office, or Headquarters' program office personnel. The
frequency of these assessments is determined by the office conducting the QSA. Every three
years, the OEI Quality Staff conducts a QSA of the Region's Quality System. The QSA Team
usually consists of members from the OEI Quality Staff and at least one person from another
Region or EPA Headquarters Program Office. The scope of their assessment is determined by
the OEI QSA Team. The RQAM and RQC shall assist the OEI QSA team by handling the
logistics and scheduling interviews.
The findings of the OEI QSA are documented in a Draft Findings Report. After the
Region's Senior Management and the OEI QSA Team reach consensus on the accuracy of the
observations made in the QSA Draft Findings Report, the Findings Report is finalized. If
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EPA Region III Quality Management Plan October 2008
corrective actions are required, the RQC with input from Senior Managers shall develop the
Region's Corrective Action Plan. Milestones will be developed so that progress on corrective
actions can be measured. This information will be included in the assessment file, which is
maintained by the RQAM, or designee. Region III managers are responsible for ensuring
compliance with the approved corrective actions. The RQC will periodically provide Senior
Managers with information about the Region's progress on implementation of the Corrective
Action Plan.
D.3. TECHNICAL SYSTEMS AUDITS
The goal of the technical systems audit (TSA) is to determine whether environmental
data operations and related results comply with the project's QAPP and other planning
documents. A TSA compares the implemented activity against the documented (i.e., QAPP,
SOP, manual, etc.) activity. TSAs may also be used as an investigative tool when problems are
suspected. It is usually project-specific, and
is usually conducted in the field or
laboratory.
of the facilities, equipment, personnel,
Grantees with approved QMPs may ^^ dures> record.keepmg,
conduct TSAs of their own environmental
A
systematic and objective examination
data validation, data management
and analysis, and reporting aspects of
an environmental measurement
system.
data operations. In some instances, Region
III is required by regulation to conduct
TSAs of certain delegated program activities
(e.g., state drinking water analysis
laboratories and state ambient air quality
monitoring networks). To maximize the
efficient use of resources, Region III will
often times combine the TSA with mid- and end-of-year program reviews. EPA remedial and
field investigation team contractors are required to conduct TSAs of their own environmental
data operations.
At a minimum, each QAPP shall include the scope and frequency of TSAs to be
conducted during the life of the project. The QAPP shall also include the title(s) of
individual(s) responsible for conducting the TSA and the procedures to be used to implement
corrective actions. The QAPP reviewer shall ensure that information about TSAs is
documented in the QAPP. The Project Manager or Project Officer is responsible for ensuring
the specified TSAs are accomplished. The individuals conducting the technical system audit
should be knowledgeable of the procedures being audited. These individuals should also have
professional knowledge of chemical and biological principles, theories, practices and
established methods. Extensive knowledge of the principles and practices of quality assurance
and the ability to adapt these applications to Agency programs is also required.
All programs in the Region that employ environmental data operations are subject to a
TSA. EPA's Guidance on Technical Audits and Related Assessments for Environmental Data
Operations, EPA QA/G-7, January 2000, available at http://www.epa.gov/quality/qs-docs/g7-
final.pdf may be used as a resource for planning, conducting, evaluating and documenting
technical systems audits and related assessments. The RQAM (or designee) shall ensure that a
description of applicable TSAs is included in all QMPs and that all QMPs include the title(s) of
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EPA Region III Quality Management Plan October 2008
the individual(s) responsible for conducting TSAs.
D.4. LABORATORY AUDITS
The OASQA Technical Director, with the support of OASQA staff conducts
assessments of laboratories that support the National Pollution Discharge Elimination
System (NPDES) program and the Safe Drinking Water Act (SOWA) program. OASQA
personnel may also conduct assessments of laboratories being used by some Superfund
Potentially Responsible Parties (PRPs). Sample Brokerage personnel conduct assessments
of laboratories that participate in the Contract Laboratory Program and the Regional
laboratory contract procurement process. OASQA also performs inspections under the
National Environmental Laboratory Accreditation Program (NELAP) for the review of
Accrediting Bodies (AB).
D.4.a. National Pollution Discharge Elimination System
OASQA conducts laboratory assessments of National Pollution Discharge Elimination
System (NPDES) permittees' and commercial laboratories analyzing compliance samples.
Inspections are performed at the request of and in partnership with the State Authority and may
be announced or unannounced to the facility. The goals of these assessments are to:
improve Discharge Monitoring Reports Quality Assurance (DMRQA) performance;
provide technical assistance to States that have limited expertise in certain analytical
methodology;
improve analytical QA/QC procedures; and
improve documentation procedures.
During the DMRQA laboratory
assessments, analytical procedures;
sampling procedures; equipment;
instrumentation; record keeping;
documentation; analytical data and
Proficiency Testing (P/T) sample results
are reviewed. A Data Audit Inspection
(DAI) is also conducted. If routine
problems are found in the P/T sample
results, a more extensive tracking of P/T
sample results will occur until successful performance is achieved. Laboratory assessment
reports are completed within 30 days of the assessment and follow-up corrective actions are
tracked (corrective action reports are required within 45 days of the assessment through the
issuance of a Deficiency Notice). The OASQA Technical Director is responsible for tracking
corrective actions for NPDES permittee laboratories and commercial laboratories analyzing
compliance samples. The procedures employed are described in NPDES Self-Monitoring Data
and Data Inspections DAIs, EPA-903-R-94-043, Fall 1994.
D.4.b. Safe Drinking Water Act
OASQA performs laboratory inspections of Region III State Laboratories using
33
A DAI consists of recalculating the results
from unprocessed instrument results and
comparing them to the results reported on
the Discharge Monitoring Reports
(DMRs).
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EPA Region III Quality Management Plan October 2008
procedures specified by the Agency's Manual for the Certification of Laboratories Analyzing
Drinking Water: Criteria and Procedures Quality Assurance, Fifth Edition, EPA 815-R-05-004,
January 2005 (or most current version) and the OASQA SOP, On-site Laboratory Assessments in
the Drinking Water Laboratory Certification Program, R3-QA801.0, September 2001 (or most
current version). The procedures for the Data Audit Inspections are similar to those described
above. On-site assessments are conducted every three years and corrective actions are tracked
and official certification update reports are issued. The OASQA Technical Director is
responsible for tracking corrective actions. OASQA also performs reviews of the Region III
State Safe Drinking Water Act (SOWA) Laboratory Certification Programs as per the laboratory
certification manual. Every three years, the assessments and program are reviewed by the Office
of Ground Water and Drinking Water through yearly questionnaires and on-site inspection.
D.4.c. Laboratories Used by Potentially Responsible Parties
OASQA personnel may conduct limited inspections of laboratories used by Region III
Superfund Potentially Responsible Parties (PRPs). The Region III Hazardous Site and Cleanup
Division (HSCD) selects the PRP laboratories to be inspected. These laboratory inspections are
conducted in accordance with the procedures found in the Standard Operating Procedure for On-
site Inspection of Superfund PPJ* Monitoring Procedures, December 2000 (or most current
version). The procedures for the Data Audit Inspections are similar to those described above.
The PRP laboratory inspections include the review of PT sample results; the site's QAPP and/or
SAP; and the site's third party data validation reports. Prior to distribution of the laboratory
inspection findings report to the appropriate HSCD Project Officer, the report shall be reviewed
by the OASQA Quality Assurance Staff. The OASQA Technical Director is responsible for
tracking the corrective actions for PRP laboratories.
D.4.d. Contract Laboratory Program
The Contract Laboratory Program (CLP) Project Officer conducts annual on-site audits
of CLP laboratories located in Region III. These audits are conducted in accordance with
procedures found in the applicable CLP Statement of Work. The national Contract Laboratory
Program processes the data through an automated Data Assessment Tool (DAT). DAT is a
complete data assessment package that incorporates Contract Compliance Screening (CCS) and
data usability reviews to provide EPA Regions with electronic data usability and compliance
reports, spreadsheets, and files within 24 to 48 hours from the receipt of data from laboratories.
This automated tool facilitates the transfer of analytical data into Regional databases. In
addition to the Regional electronic reports, the CLP laboratories are provided with a data
assessment report that documents the instances of non-compliance. The CLP Quality
Assurance and Technical Support (QATS) contractor performs data evaluation and review
services. This three-step review process provides the CLP customer with data of known and
documented quality.
When the data package is delivered to the Regional Sample Control Center, the package
is subject to an evidentiary audit to evaluate the documentation for chain-of custody and sample
handling procedures. It also undergoes a data validation process following the National
Functional Guidelines (most current version), to further assess the quality and usability of the
data.
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EPA Region III Quality Management Plan October 2008
The above described activities are used to assess a CLP laboratory's overall performance.
Corrective actions from these laboratory checks are monitored by the Region III CLP Project
Officer. If there are significant contract non-conformances, the Region III CLP Project Officer
forwards this information to the National CLP Program Manager and Contracting Officer for
appropriate action. This action may include the rejection of data and/or a reduction in payment.
D.4.e. Other Analytical Services
For the analysis of samples for non-CLP methods, the Region contracts laboratories via
its own procurement process. Whenever possible, the Region will use laboratories participating
in the CLP for non-CLP analytical services. The use of a CLP laboratory, provides the Region
with access to information about a laboratory's performance (i.e., quarterly blind Proficiency
Testing sample results, on-site audit reports, etc.). Prior to contract award, laboratories must
provide a copy of their quality manual, which should include the laboratory's quality policy; a
description of the laboratory facilities; a list of personnel with qualifications; measurement and
calibration procedures; procedures for data review and corrective action procedures. For non-
routine methods, the laboratory must also submit an initial demonstration of capability for the
non-routine method. OASQA evaluates the laboratory's quality documentation to determine its
capability to conduct the requested analyses.
OASQA also conducts on-site audits of the regionally contracted laboratories. The
procedures in the applicable CLP Statement of Work may be used to conduct these on-site
audits. If applicable, the CLP on-site audit checklist may be used for specific analytical fractions
(i.e., volatiles, semi-volatiles, pesticides, metals, cyanide, etc.). The Regional contract laboratory
data is subject to the same evidentiary audit and data validation procedures as CLP data.
Corrective actions are monitored by the Region III Project Officer. If significant contract non-
conformance is found, the Region III Project Officer may recommend rejection of the data
and/or reduction in payment.
D.4.f. National Environmental Laboratory Accreditation Program
OASQA participates in inspections under the National Environmental Laboratory
Accreditation Program (NELAP) for the review of Accrediting Bodies (AB). The procedures
for conducting these inspections are documented in Chapter 6 of the National Environmental
Laboratory Accreditation Conference (NELAC) standards, available at http://www.nelac-
institute.org/. The results of the inspections are documented in a checklist. Findings are
resolved with the ABs and the final reports are sent to the NELAP Board for final review and
approval. The program's procedures, assessments and accreditation are reviewed annually by
the NELAP Board as described in Chapter 6 of the NELAC standards.
D.5. PROFICIENCY TESTING SAMPLES
A Proficiency Testing (P/T) sample is used as a quantitative audit of analytical results
generated by a measurement system. Whenever possible, the proficiency testing sample shall
mimic the matrix of the routine field sample. The concentration of the P/T sample shall be
unknown to the analyst. The results of the P/T sample are used to determine if a measurement
system's results are within the measurement quality objectives specified by the Program (i.e.,
CLP, Drinking Water, Quality Assurance Technical Support laboratory, etc.) or found in the
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EPA Region III Quality Management Plan October 2008
QAPP. The procedures being used for the acquisition and evaluation of proficiency testing
samples shall be included in the QMP, Laboratory Quality Manual or project QAPP.
D.6. DATA VERIFICATION & VALIDATION
Data verification and data validation are key steps in the assessment phase. Data
verification is the process of evaluating the completeness, correctness, and
conformance/compliance of a specific data set against the method, procedural, or contractual
requirements. The goal of data verification is to ensure and document that the reported results
reflect what was actually done. Data verification may be performed by personnel involved with
the collection of samples or data, generation of analytical data, and/or by an external data
verifier. Some programs may require the conduct of external data verification upon receipt of
data packages to confirm the completeness of the data package and to permit authorization of
payment for the work.
Data validation is an analyte- and sample-specific process that extends the evaluation of
data beyond verification to determine the analytical quality of a specific data set. The goal of
data validation is to evaluate whether the data quality goals established during the planning phase
have been achieved. Data validation is typically performed by person(s) independent of the
project activity. The appropriate degree of independence will be determined on a program
specific basis. At a minimum, the individual(s) conducting the validation should not belong to
the same organizational unit with immediate responsibility for producing the data set. Data
quality indicators (such as precision, bias, comparability, sensitivity, representativeness, and
completeness) are typically used as expressions of the quality of the data.
Personnel performing data verification and validation should have professional
knowledge of chemical and biological principles, theories, practices and established methods,
statistical techniques commonly used in quality control, data assessments, and data management
practices. Extensive knowledge of the principles and practices of quality assurance and
familiarity with the project-specific data quality indicators is also necessary. The specific
procedures and title(s) of the individual(s) responsible for data verification and validation shall
be included in the project's QAPP or SAP. Results of the data verification and validation should
be documented and provided to the Project Manager/Project Officer. EPA's guidance
documents Guidance on Environmental Data Verification and Data Validation, EPA QA/G-8,
November 2002, available at http://www.epa.gov/quality/qs-docs/g8-fmal.pdf and US EPA's
Contract Laboratory Program National Functional Guidelines., available at
http://www.epa.gov/superfund/programs/clp/guidance.htm may be used to conduct the data
verification and validation processes.
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EPA Region III Quality Management Plan October 2008
D.7 DATA QUALITY ASSESSMENT
A Data Quality Assessment (DQA) is
the scientific evaluation of data to
determine if they meet the planning
objectives of the project, and thus are
of the right type, quality, and quantity
to support their intended use.
The scope of the DQA should be
commensurate with the project objectives and
intended use of the data. EPA's guidance
documents Data Quality Assessment: A
Reviewer's Guide, EPA QA/G-9R, February
2006 and Data Quality Assessment: Statistical
Methods for Practitioners, EPA QA/G-9S,
February 2006, available at
http://www.epa.gov/quality/qa_docs.html#guida
nee may be used to conduct the DQA. The
specific procedures to be followed for data quality assessments shall be included in the project's
QAPP or SAP. The title(s) of the individual(s) responsible for the DQA process shall also be
included in the project QAPP or SAP. The results of the DQA should be documented and
provided to the Project Manager/Project Officer.
At a minimum, all environmental data shall be reviewed to ensure that the analytical
measurement criteria specified in the approved QAPP has been achieved. Data shall be qualified
in accordance with the data validation criteria specified in the approved QAPP.
D.8. PEER REVIEW
Peer review is intended to uncover any technical problems or unresolved issues in a
preliminary work product through the use of independent experts. This information is then used
to revise that draft product so that the final work product will reflect sound technical information
and analyses. Peer review is a process for enhancing a scientific or technical work product so
that the decision or position taken by the Agency, based on that product, has a sound, credible
basis. To be most effective, peer review of a scientific and/or technical work product should be
incorporated into the up-front planning of any action based on the work product - this includes
obtaining the proper resource commitments and establishing realistic schedules. Peer review
takes many different forms depending on the nature of the work product, relevant statutory
requirements, and office-specific policies and practices. It is Region III practice that Project
Managers/Project Officers, in consultation with their first line supervisors, senior managers and
technical staff, will make the decision on whether his/her project should be peer reviewed and
what level that peer review will take. When applicable, Region III follows the procedures and
guidance found in EPA's Peer Review Handbook, 3rd Edition, EPA/100/B-06/002, 2006,
available at http://www.epa.gov/osa/spc/2peerrev.htm.
D.9. QUALITY IMPROVEMENT
The quality assurance procedures described in this QMP establish a foundation for
ensuring that data of acceptable quality for its intended use will be used to make environmental
decisions. One of the goals of the Region III Quality System is to incorporate quality assurance
as a critical component of all the work functions within our programs.
All Regional personnel are encouraged to raise issues that impact the quality of data and
information being generated and/or used by the Region. Issues should be raised to the
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EPA Region III Quality Management Plan October 2008
designated Division or Program Office QA Coordinator. If these issues impact more than one
Division or Program Office, the QA Coordinator will facilitate a discussion of the issue during
the scheduled RQC meeting. Based on these discussions, the RQC will make a recommendation
to Senior Management about ways to resolve the issue and improve the Region's Quality
System. If the issue requires immediate action, it will be forwarded to the Senior Management
Representative to the RQC. The Senior Management Representative to the RQC will then
determine the appropriate mechanism to resolve the issue. Whenever possible, the RQC will be
involved in discussions about issues that impact the Region's Quality System.
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EPA Region III Quality Management Plan October 2008
SECTIONE: INFRASTRUCTURE
E.I. QUALIFICATIONS AND TRAINING
All Regional personnel involved
with environmental data operations shall
Region III Policy
It is Region Ill's policy to provide the training
necessary to ensure that all per sons involved in
handling environmental data understand the
Region's Quality System.
be required to have the appropriate QA
training. It shall be the responsibility of
the Directors of all Region III Divisions
and Program Offices to ensure that the
individuals in their organizations meet the
minimum QA training requirements for
their assigned activities. The following sections describe Region Ill's QA training program and
the requirements for Regional personnel involved with environmental data operations.
E.l.a. Region III QA Training Program
The Region is committed to ensuring that all personnel have the necessary skills to
effectively accomplish the tasks that have been assigned. To facilitate this process, it is
imperative that all individuals involved with environmental data operations obtain information
about EPA QA requirements and understand their QA roles and responsibilities.
Each Region III Division or Program Office shall determine their organization's QA
training needs in accordance with the procedures specified in their Division/Program Office
QMP. EPA's Guidance for Developing a Training Program for Quality Systems, EPA QA/G-
10, December 2000, available at http://www.epa.gov/quality/qs-docs/glO-fmal.pdfmay be used
as a tool for this exercise. Senior Managers must ensure that adequate resources are available to
implement the Region III QA Training Plan. Annually, the RQC shall review these QA training
needs to determine if the training needs for Divisions and Programs are similar. When similar
QA training needs have been identified, the RQC shall determine the feasibility of offering a
Region-wide QA training course(s). The RQC shall then identify the most cost-effective
method(s) to obtain Region-wide QA training.
The implementation of QA requirements for extramural agreements is a critical
component of the Region's Quality System. Project Managers/Project Officers/Work
Assignment Managers are responsible for assisting major assistance agreement holders obtain
necessary QA-related training.
This section describes the desired core Region-wide QA training courses, the program
logistics, associated documentation and requirements. The Region is in the process of
rebuilding its QA training program.
E.l.b. Courses
Table E. 1 describes the core QA courses that are being developed and offered to Region
III personnel and Region III state and local government agencies. More courses may be
developed as additional training needs are identified.
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EPA Region III Quality Management Plan
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Table E.I. Core Quality Assurance Courses
Course Title
Region III Quality System
Awareness
Systematic Planning for
Environmental Data Operations
Quality Assurance Project Plans
Data Evaluation
Information Quality Guidelines
(On-line at:
http ://intranet. epa. gov/quality/inf
ormationguidelines/files/iqg-
overview.ppt)
QA Refresher (On-line - under
development)
Description
A detailed overview of the Agency's quality system
requirements and how they are implemented in
Region III.
This course shall provide an overview of systematic
planning. During this course, participants will learn
the elements of a systematic planning approach
based on the scientific method.
This course shall provide an overview of the twenty-
four QAPP elements found in QA/R-5 and the UFP-
QAPP. During this course, the need for systematic
planning and EPA's graded approach to project plan
development shall be emphasized. Based on the
training needs of the audience, the course may either
focus on how to write a QAPP or how to review a
QAPP.
This course shall provide an overview of data
validation and usability. Participants will acquire
knowledge of 1) the importance of data validation;
2) Region Ill's data validation procedures; and 3)
the usability of data against project objectives.
Participants will acquire: 1) knowledge of the origin
and intent of the 2001 Data Quality Act; 2)
information on the implementation of EPA's
Information Quality Guidelines (IQGs); 3) insight
on managing IQG requests; and 4) appreciation of
the impact of the IQGs on enhancing EPA's Quality
System.
A briefing on updates/changes to the quality system;
required for Region III staff every 2 years to
maintain QA proficiency.
E.l.c. Logistics
The Region III QA training program shall be administered through a collaborative effort
between the Region's EAID and the RQC. Additional training support for non-routine topics
may be provided by the OEI Quality Staff, other Regions, other Federal Agencies, local
universities, contractors and professional organizations. The Region III OPM shall arrange for
training announcements and training rooms. When additional QA training is required, Program
Managers shall forward this training request to their Division or Program Office QA
Coordinator, who is then responsible for bringing it to the attention of the RQAM and RQC.
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EPA Region III Quality Management Plan October 2008
E.l.d. Documentation of Training
After completion of each QA training course, attendees shall receive a certificate of
completion from the organization providing the training. For this reason, attendance at all
courses shall be recorded. OPM shall maintain a record of all Q A training taken by all
personnel. This record shall be maintained in OPM's training data base. Upon request, OPM
shall provide Division and Program Office Directors with a list of individuals within their
Division/Program Office who have completed core QA training courses. Division and Program
Office Directors shall use this information to determine whether appropriate members of their
staff meet the minimum training requirements for their assigned activities. At the end of each
fiscal year, the RQAM or designee shall provide a summary of the QA training courses that have
been offered in the Region in the QA Annual Report and Work Plan. This summary shall
include, but is not limited to the courses offered, the number of attendees and a list of all non-
EPA participating organizations.
E.l.e. Training Requirements
Table E.2 illustrates the required QA-related training courses by functional role/title.
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EPA Region III Quality Management Plan
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Table E.2. Training Requirements by Functional Role/Title
Regional Administrator & Senior
Leadership
Program Managers (Branch
Chiefs / Section Chiefs / Team
Leaders)
Project Managers / Project
Officers / Work Assignment
Managers / etc.
Regional QA Manager
Regional QA Officer
Quality Assurance Coordinators
Information Quality Guidelines
Officer
Technical QA Staff
SGH/JCGS
. Client Services
Branch Staff
Laboratory Branch & Freshwater
Biology Team
Region III
Quality System
Awareness
X
(briefing only)
X
X
X
X
X
x
/\
X
X
Systematic
Planning for
Environmental
Data Operations
X
X
X
X
X
X
Quality Data Quality System
Assurance Evaluation Assessments
Project Plans
X X
XXX
XXX
XXX
XXX
XXX
Information
Quality
Guidelines
X
(briefing only)
X
X
X
X
X
x
/\
X
X
Refresher
X
X
X
X
X
x
/\
X
X
per respective Laboratory Quality Manuals
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EPA Region III Quality Management Plan
October 2008
E.2. PROCUREMENT AND FINANCIAL ASSISTANCE
E.2.a. Procurement - Contracts
The Contracts Branch within the Office of Policy and Management is responsible for
developing and keeping current Regional purchasing policies and procedures. Quality assurance
requirements for contracts are set forth in the EPA Contracts Management Manual (Section
7.3.5.3 and Chapter 46) and the Federal Acquisition Regulation (FAR) 46.202-4 and 52.246-01.
All procurements originating in Region III must meet established administrative and quality
assurance requirements in the latest editions of the:
Federal Acquisition Regulations, Part 13
Acquisition Handbook (http://intranet.epa.gov/oamintra/policy/ah(new).pdf)
Contracts Management Manual (http://epawww.epa.gov/oamintra/policy/cmm.pdf)
In order to assure that contractually procured environmental data operations are
scientifically valid, defensible, and of known precision and accuracy, Contract Project Officers,
Contracting Officer Representatives, and Contracting Officers are responsible for adhering to
EPA's Guidance for Use of Higher-Level Contract Quality Requirements in Acquisitions,
Procurement Policy Notice 01-02, March 2001. Requirements include the QA Review Form,
modified for Region III, as shown in Appendix B. The QA Review Form shall be completed
and signed by the Project Manager/Project Officer. The Project Manager/Project Officer
signature indicates that the agreement clearly describes the item or service needed and that
associated technical and quality requirements are defined. The RQAM reviews and signs the
QA Review Form to assure that all environmental data operations contractually funded by EPA
are in compliance with EPA Order 5360.1 A2 (CIO Policy 2105.0). Where QA requirements
apply, the Contracting Officer will assure that quality assurance terms and conditions are
included in contract statements of work. The quality assurance term and condition requires
contractors to document its quality system in a Quality Management Plan and submit quality
assurance project plans or appropriate planning documents that meet EPA program-specific
project goals and objectives. The EPA Project Manager/Project Officer will assure that the
contractor complies with the conditions and deliverables.
Region III Policy
Contracts procured by Region 111 (as opposed to
those originating at Headquarters) involving
environmental data operations shall submit a
QMP prepared in accordance with the
specifications provided in the most current version
of EPA Requirements for Quality Management
Plans, QA/R-2.
The QMP documents and
describes the quality system
implemented by the applicant. The
QMP shall be reviewed and approved by
the EPA Contracting Officer, the EPA
Project Manager/Project Officer, and the
RQAM as described in Section A.S.c of
this QMP as a condition for award of
any contract. The QMP should ideally
be submitted as part of the application.
If the QMP is not submitted as part of the application and EPA decides to award the
contract, EPA will include a term and condition in the contract. This term and condition requires
the recipient to submit the QMP within a specified time after award of the contract and notifies
the recipient that they may not begin work involving environmental data operations until the
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EPA Region III Quality Management Plan October 2008
EPA Contracting Officer informs them that the QMP has been approved.
The contractor shall also be required to submit QAPPs to EPA for review and approval
by the EPA Project Manager/Project Officer according to the procedures described in Section
B.3.b of this QMP prior to undertaking any work involving environmental programs.
Region III typically employs the use of contract vehicles procured at the headquarters
level; however, when a contract originates at the regional level and involves the generation
and/or use of environmental data, the RQAM or an individual knowledgeable in QA (e.g., a
member of the Quality Assurance Staff or the division/office Quality Assurance Coordinator)
may be included as part of the Technical Evaluation Panel (TEP) to evaluate the satisfaction of
technical and quality requirements. The TEP develops the evaluation criteria and the Statement
of Work for the solicitation and performs the technical evaluation of offers. Ultimately, the
Project Manager/Project Officer is responsible for ensuring that procured items and services
conform to specifications and needs of the program prior to payment as well as throughout the
life of the contract or purchase. The quality requirements of the items or services to be
purchased for a given program are defined in its Division/ Program Office QMP. The quality
requirements of the items or services to be purchased for a given project are defined in the
project QAPP, SOP or other planning document. When program needs/requirements change and
the changes affect the technical specifications of the required goods and services, these changes
need to be documented in the applicable QMP, QAPP, SOP or other planning document prior to
initiating additional purchases or change orders.
E.2.a.l. Small Purchases
Region III Policy
Procurement of environmentally related
measurements or data generation which qualifies
as small purchases under the Federal Acquisition
Regulations (FAR) is subject to QA requirements.
Procurements qualifying as
small purchases must meet
established administrative and QA
requirements of the Federal
Acquisition Regulations (FAR),
Federal Information Resources
Management Regulations (FIRMR),
Delegation 1-84 (1200 TN310),
Office of Information Resource Management (OIRM) Delegation 1-10A (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. Bankcard, blanket purchase order, and federal
supply schedule procurements involving environmental data operations will adhere to the above
Region III requirements.
E.2.a.2. Procurement of Analytical Services
Procurement of analytical services obtained through the Region's Sample Brokerage,
including the Superfund CLP, Headquarters' non-Routine Analytical Services (non-RAS)
contracts, and regionally awarded contracts are subject to QA requirements.
In order to request analytical services, the requester, usually a Project Manager/Project
Officer, must produce an approved QAPP or SAP. The QAPP or SAP includes information such
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EPA Region III Quality Management Plan October 2008
as project objectives, number of samples to be collected and analyzed, parameters of interest,
reporting limits, and other QA requirements. The QAPP and/or SAP are used to develop the
analytical requirements for the procurement, which are incorporated into the Analytical Request
Form. The Analytical Request Form and instructions can be found at
http://www.epa.gov/region3/esc/labservices.htm.
When the analytical requirements are approved, Sample Brokerage personnel, in
consultation with the requester, apply the Field and Analytical Services Team Advisory
Committee (FASTAC) process to determine the most appropriate mechanism to acquire the data.
The data may be acquired via one of the following mechanisms in the order presented:
1. EPA Regional Lab
2. CLP lab
3. Regional contract
4. Field contractor subcontract
If data are to be acquired via # 3, Regional contracts, Sample Brokerage personnel create
a bid solicitation form that incorporates the approved analytical requirements. The bid
solicitation is distributed to participating commercial labs for price quotations. Participating labs
must provide the most current version of their Quality Manual for review. The lab's Quality
System, as documented in the Quality Manual, is assessed to ensure that it conforms to the
requirements found in the most recent version of ISO 17025, NELAC Chapter 5 or ANSI/ASQC
Q2-1991. If the laboratory's documented quality system is acceptable, the laboratory's solicited
bid is considered.
All environmental data acquired through the Sample Brokerage is reviewed to determine
whether it meets the analytical requirements specified in the QAPP/SAP and analytical request.
Remedies, including request for additional information, data qualification, and/or payment
penalties may be applied to data that does not conform to requirements.
E.2.b. Financial Assistance
E.2.b.l. Grants and Cooperative Agreements
Region III Policy
All applicants for grants or cooperative
agreements involving environmental data
operations shall submit a QMP prepared in
accordance with the specifications provided in the
most current version of the EPA Requirements for
Quality Management Plans, EPA QA/R-2.
The QMP documents and
EPA quality assurance
requirements for grants and
cooperative agreements are contained
in 40 CFR 30 for universities and
other non-profits and 40 CFR Parts 31
and 35 for state, tribal, and local
governments.
describes the quality system implemented by the applicant. The EPA Project Manager/ Project
Officer will ensure the agreement clearly describes the item or service needed and that
associated technical and quality requirements are defined. The Project Manager/Project Officer
will also indicate on the Funding Recommendation whether the project involves environmental
data operations. If it does, EPA will insert a term and condition in the grant or assistance
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EPA Region III Quality Management Plan October 2008
agreement per the Region III Quality Assurance Requirements for Grants and Cooperative
Agreements, November 7, 2000 (Appendix A). The term and condition requires the recipient to
submit the QMP within a specified time and notifies the recipient that they may not begin the
work involving environmental data operations until the QMP has been approved by the EPA
RQAM.
A condition will also be included in the assistance agreement requiring the recipient to
submit a QAPP to EPA for review and approval by the EPA Project Officer prior to the initiation
of projects involving environmental data operations. The QAPP shall be prepared in accordance
with the specifications provided in the most current version of the EPA Requirements for Quality
Assurance Project Plans, EPA QA/R-5; which describes the quality assurance and quality
control activities to be implemented for the work involving environmental data operations.
The Grants Specialist will assure that the terms and conditions are included in the
assistance agreements where QA requirements apply. The EPA Project Manager/Project
Officer will assure that the grantee complies with the conditions. On a monthly basis, the
RQAM reviews notifications of newly awarded grants, cooperative agreements and lAGs to
determine whether QA requirements were appropriately addressed. The results of this review
is tabulated and distributed to the Division/Program Office QA Coordinators for follow-up.
For certain financial assistance agreements, a combined QMP/QAPP may be
supplemented for the individual QMP and QAPP document(s). The appropriateness and content
of the combined QMP/QAPP shall be determined by the Project Manager/ Project Officer in
consultation with the RQAM, or designee. At a minimum, the combined QMP/QAPP shall
adhere to the QAPP requirements specified in Section B.3.b. of this QMP.
E.2.b.2. Inter-Agency Agreements
When Region III is providing
funds to another Federal organization,
the organization receiving the funds is
responsible for preparing the QMP or
equivalent document. If the external
organization's documented quality
system meets the requirements found in
the EPA Requirements for Quality
Management Plans, EPA QA/R-2, March 2001 (http://www.epa.gov/quality/qs-docs/r2-
fmal.pdf) or the Intergovernmental Data Quality Task Force: Uniform Federal Policy for
Implementing Environmental Quality Systems, EPA-505-F-03-001, March 2005
(http://www.epa.gov/fedfac/documents/qualityassurance.htm), their QMP, or equivalent
document shall be acceptable. If comparable QA procedures do not exist, the QA procedures
agreeable to both parties must be negotiated for the Inter-Agency Agreements (IAG). Before
any environmental data operations can be performed, the external organization must have an
approved QMP and QAPP (or equivalent documents) or successfully negotiated and acceptable
to both parties. These QA requirements are in accordance with the specifications provided in
EPA Requirements for Quality Assurance Project Plans, EPA QA/R-5, March 2001 or the
Intergovernmental Data Quality Task Force: Uniform Federal Policy for Quality Assurance
Project Plans, EPA-505-B-04-900A, March 2005, as appropriate.
46
Region III Policy
AllIAGs with environmental data operations
in which Region III funds, or participates,
shall require an approved QMP, or equivalent
document.
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EPA Region III Quality Management Plan
October 2008
In order to document compliance with the above policy, the EPA Project Manager /
Project Officer shall indicate in the IAG Program Decision Memorandum (Program Office
Authorization for the Award) whether QA requirements apply. If yes, the EPA Grants
Specialist will include a special condition in the IAG. The special condition notifies the
other Federal agency that they must submit a QMP and QAPP to the EPA Project
Manager/Project Officer and that EPA will review and concur on the QA documents (e.g.
QAPPs, SAPs and Workplan).
After the IAG is executed by both parties, it is the responsibility of the EPA Project
Manager / Project Officer to assure that the recipient of the IAG is in compliance with the QA
condition(s).
E.2.c. Evaluation of Deliverables
Project Managers / Project Officers establish the framework for monitoring the quality of
items or services by incorporating inspection and acceptance criteria into contract statements of
work or work plans for grants/interagency agreements. They are responsible for oversight and
for ensuring that products delivered are complete, accurate and meet contract, grant, co-operative
and interagency agreement requirements. Oversight of contractor QA-related products is
accomplished mainly by the efforts of the RQAM, QA Staff and/or other designated technical
specialists (e.g., QACs, risk assessors, hydrologists, etc.) as requested by the Project Manager /
Project Officer.
E.3. DOCUMENTATION AND RECORDS MANAGEMENT
Records include all books, papers, maps,
photographs, machine readable materials, or other
documentary materials, regardless of physical form
or characteristics, made or received by an agency of
the United States Government under Federal law or
in connection with the transaction of public business
and preserved or appropriate for preservation by
that agency or its legitimate successor as evidence of
the organization, functions, policies, decisions,
procedures, operations, or other activities of the
Government or because of the informational value in
them. (44 U.S.C. Chapter 33, Sec. 3301).
programs, while providing adequate preservation of key records
of the Region.
Maintaining important
QA documents and records is
a continuous process in the
Region. 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
necessary to support the mission
47
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EPA Region III Quality Management Plan October 2008
Region III adheres to the most . TTT n ,.
r-.i r- n 1 -1 s Region III Policy
recent version or the following legislation,
regulations, guidance and policies as they r, . . TTT, ,. . , . ,. ,
° . ° . J It is Region Ills policy to adopt and implement
pertain to program requirements: u A ^ ^ *
^ ^ ° n all Agency-approved records management
..TT__ _, 01 n 7 policies and guidance developed and/or
44 U.S.C. Chapter 31, Records ^,. , ,, * ^^ , ., \ . , ,. ,
/ ' , directed by the Office of Administration and
Management by r ederal »^ , j,; /->,« r
. * J Resources Management, and the Office of
Asencies'
. 44 U.S.C. Chapter 33, Disposal Environmental Information.
of Records;
18 U. S. C. Chapter 101, Records and Reports;
Paperwork Reduction Act of 1995;
OMB Circular A-13 0, Management of Federal Information Resources;
36 CFR Chapter XII, Subchapter B
Records Management Policy (CIO Policy 2155.0), U.S. Environmental Protection
Agency;
Managing Cartographic and Architectural Records (Instructional Guide Series),
National Archives and Records Administration (NARA);
Managing Electronic Records (Instructional Guide Series), NARA;
Federal Records Management Laws and Regulations, NARA;
Disposition of Federal Records: A Records Management Handbook., NARA Personal
Papers of Executive Branch Officials: A Management Guide (Management Guide
Series);
Records Disposition Schedules, U.S. Environmental Protection Agency,
http ://intranet. epa. gov/records/schedule/index.htm;
A User Guide for Getting Started in ECMS E-mail Records, U. S. EPA; and
USEPA Region III OASQA Records Management Handbook Standard Operating
Procedures, http://intranet.epa.gov/r3intran/esclibrary/rm/SOP.htm
The Enterprise Content Management System (ECMS) is the official EPA content
management program. EPA is currently in the process of rolling out ECMS for email records to
each Program Office and Region. Region III began limited implementation of ECMS in 2007.
Enterprise content management integrates technologies, tools, and methods in order to capture,
manage, store, preserve, and deliver content across an enterprise. ECMS will allow the
management of unstructured information including images, office documents, graphics,
drawings, and print streams, as well as the new electronic objects such as Web pages and
content, e-mail, video and rich media assets throughout the content's lifecycle.
The Project Manager / Project Officer is responsible for managing all project level
quality-related documents and records (paper and electronic), including transmittal, distribution,
retention, access, preservation (including protection from damage, loss, and deterioration),
traceability, retrieval, removal of obsolete documents, and disposition, in accordance with the
procedures specified in their Division/Program Office QMP. The Project Manager / Project
Officer is also responsible for ensuring that records and documents accurately reflect completed
work. The RQAM, QACs and QA Staff are responsible for managing all regional quality-
related documents and records, including transmittal, distribution, retention, access,
preservation (including protection from damage, loss, and deterioration), traceability, retrieval,
removal of obsolete documents, and disposition, in accordance with the policies and guidance
48
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EPA Region III Quality Management Plan October 2008
listed above. Each Division and Program Office is responsible for managing the custody and
confidentiality of evidentiary quality-related documents and records in accordance with
applicable regulations. Regional Records Center staff and resources are available to assist in
carrying out these responsibilities.
Further information about ECMS and records management in general can be found on
EPA Region Ill's intranet site, http://intranet.epa.gov/r3intran/oirm/recman.htm, and the EPA
National Records Management Program website: http://intranet.epa.gov/records/index.htm.
Region III staff may also contact the Records Manager with requests for technical assistance
and/or training.
E.S.a. Ensuring Documents and Records Accurately Reflect Completed Work
Each office is responsible for establishing and implementing procedures for ensuring
consistency and technical accuracy of its work products. It is the Senior Leadership's
responsibility to ensure that each Division/Program Office uses established procedures to ensure
that disseminated information products are of adequate quality for their intended use and comply
with EPA's Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and
Integrity of Information Disseminated by the Environmental Protection Agency, EPA/260R-02-
008, October 2002 and EPA Region Ill's Information Quality Guidelines Pre-Dissemination
Review, PDR Version 1.1, July 2007.
E.4. COMPUTER HARDWARE AND SOFTWARE
The Environmental Protection Agency's ability to fulfill its mission is dependent upon a
strong information technology infrastructure. Mission objectives rely on an infrastructure that is
capable of supporting environmental information and dynamic communication among EPA
offices. One of the most critical components of the EPA infrastructure is information
technology. The hardware, software, and communications components that are encompassed by
information technology form the foundation for environmental information and EPA-wide
communication. The management of information technology, therefore, is critical to the success
of the EPA.
The Office of Environmental Information (OEI) is responsible for managing the EPA's
information technology infrastructure and components. In that role, OEI has established
information technology standards to manage and ensure that information technology components
integrate properly into the infrastructure.
E.4.a. Roles and Responsibilities
The Computer Services Branch (CSB) is responsible for local area and wide area network
support; managing and operating the regional computer center; providing data communications
services; personal computer planning and operational support; information technology security;
and management of regional word processing support. CSB also participates in overall
information management for the Region in cooperation with the Environmental Assessment and
Innovation Division (EAID) and the Information Services Branch (ISB). CSB focuses on
desktop applications when participating in information management activities.
49
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EPA Region III Quality Management Plan October 2008
ISB is responsible for the life cycle management of information systems (i.e., feasibility
study, analysis, design, programming, implementation, testing, operations, maintenance and
systems review). It provides management and operational support to the operating divisions for
all information systems utilized by the region; and for managing and operating the Regional
Center for Environmental Information (RCEI). ISB also participates in overall information
management for the Region in cooperation with EAID and CSB for matters concerning
information systems.
E.4.b. Region III Information Management Systems
All information management system development, improvements, and updates will
comply with Information Resources Management Policy., CIO Policy 2100.0 to include a
systematic and comprehensive dialogue among the data providers, data and system users, and
system developers, prior to the design of the system.
It is Region III policy to work closely with the Office of Environmental Information on
all phases of system development, improvements, and updates. During the operational phases of
information management systems, Region III will comply with requirements within CIO Policy
2100.0, Information Resources Management Policy Manual and CIO Policy 2121.0, System Life
Cycle Management Policy. Both are located on the OEI Intranet site:
http://intranet.epa.gov/oeiintra/imitpolicy/policies.htm. The goal of this process is to have a
uniform approach and review of applications under consideration by Region III. The process
will determine if an application has management support, IRM support, is doable in the time
frame needed, and is within the resource constraints identified. Compliance with the applicable
information resource management standards will ensure that all hardware and software
configurations are tested prior to use, to guarantee they perform as expected and meet user
requirements.
For information technology contracts that involve applications development, the
performance work statement will include, but not be limited to, requirements for system
specification reviews; system development plans; data validation and transfer; acceptance
testing, and report generation.
E.4.c. Data Standards
All Federal agencies are required to adhere to Federally-mandated data standards and
regulations. It is the policy of Region III to comply with all applicable regulations, guidance,
executive orders, and internal policy documents concerning data standards. These include, but
are not limited to:
The National Institute of Standards and Technology develops standards and guidelines to
achieve the most effective use of Federal information.
The Federal Information Processing Standards (available at
http://www.itl.nist.gov/fipspubs/) are the Federal data standards for all data exchange
among agencies.
The EPA Data Standards Program is established and documented in the Information
Re sources Management Policy, CIO Policy 2100.0 and Data Standards, CIO Policy
2133.0.
50
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EPA Region III Quality Management Plan October 2008
Within EPA, adherence to data standards policy is accomplished through the direction of
OEI. EPA's data-related policies apply to all EPA organizations and personnel, including
contractors, Senior Environmental Employee (SEE) Program participants, and other personnel
assigned to EPA who design, implement, and maintain information management systems for
Region III and EPA. Additional information on secondary use of environmental information
and/or data can be found in Section B.3.d.
51
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EPA Region III Quality Management Plan October 2008
Figures
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EPA Region III Quality Management Plan October 2008
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Figure 1
Environmental Protection Agency, Region
OFFICE OF POLICY AND
MANAGEMENT
James W. Newsom
Assistant Regional Administrator
John J. Krakowiak, Acting Deputy
AIR PROTECTION DIVISION
Judith Katz, Director
David L. Arnold, Deputy
REGIONAL ADMINISTRATOR
Donald S. Welsh
DEPUTY REGIONAL ADMINISTRATOR
William T. Wisniewski
OFFICE OF PUBLIC AFFAIRS
Thomas M. Damm, Director
Michael Kulik, Deputy
WATER PROTECTION DIVISION
Jon M. Capacasa, Director
John A. Armstead, Deputy
OFFICE OF STATE AND
CONGRESSIONAL RELATIONS
Catherine Libertz, Director
HAZARDOUS SITE CLEANUP DIVISION
James J. Burke, Director
Kathryn Hodgkiss, Deputy
CHESAPEAKE BAY PROGRAM
OFFICE
Jeffrey Lape, Director
Diana Esher, Deputy
OFFICE OF ENFORCEMENT,
COMPLIANCE AND ENVIRONMENTAL
JUSTICE
Samantha Beers, Director
OFFICE OF REGIONAL COUNSEL
William C. Early, Regional Counsel
Lydia Isales, Deputy
LAND AND CHEMICALS DIVISION
Abraham Ferdas, Director
Wayne S. Naylor, Deputy
ENVIRONMENTAL ASSESSMENT
AND INNOVATION DIVISION
John "Randy" Pomponio, Director
Tai-Ming Chang, Deputy
July 2008
Regional QA Manager
Terry Simpson
-------
Figure 2
Region III QA Functional Responsibilities
Council Members
Senior Management Representative
RQAM, RQAO
QA Coordinators
IQG Officer
OASQA QA Staff Representative
RQC
Implements the Region's Quality System
Develops QA policies and procedures
Reviews and updates the Region's QMP
Develops Regional QA training plan
Establishes annual QA priorities
Conducts QSAs of Regional operations
Reviews & implements QSA recommendations
RQAM
Oversees implementation of the Region's QS
Facilitates development of Region's QMP & QA policies
Approves QMPs & Conduct QSAs
Conducts or coordinates QA Training
Provides QA assistance to Mgrs, QACs & Staff
Coordinates & submits Regional QAARWP
Regional Administrator
Ensures Region III complies w/EPA Order 5360.1 A2
Provides resources for implementing the Region III
Quality System
Issues Region's QMP & Annual Report
Ensures all EDOs are covered by appropriate QA
documentation
Resolves disputes regarding Quality System requirements
Senior Leadership
Responsible for Division/Program Office Quality System
Issues Division/Program Office QMP
Ensures all EDOs are covered by appropriate QA
documentation
Ensures Regional Divisions/Program Offices comply
w/EPA Order 5360.1 A2
Ensures extramural agreement holders comply w/QA
requirements
Senior Management Representative
Serves as liaison between Sr. Leadership and the RQC
Resolves disputes regarding Quality System requirements
1
1
'QAC
Coorc
Helps
Revie
Asses
Cond
Cons
Provi
^L Mar
Coordinates QA activities within the Division/Program Office
Helps Division/Program Office implement its QMP
Reviews Division/Program Office QAPPs & SOPs
Assesses Division/Program Office QA training needs
Conducts internal QSAs
Consolidates Division/Program Office QAARWP
Provides QA assistance to Division/Program Office
Managers & Staff
DMRQA = Discharge Monitoring Report Quality Assurance
DW= Drinking Water
EDO = Environmental Data Operation
IQG = Information Quality Guidelines
NPDES = National Pollutant Discharge Elimination System
NPO = National Program Office
OASQA = Office of Analytical Services and Quality Assurance
PM/PO = Project Manager / Project Officer
PT = Proficiency Test
QA = Quality Assurance
QAPP = Quality Assurance Project Plan
QAARWP = Quality Assurance Annual Report and Work Plan
QC = Quality Control
QMP = Quality Management Plan
QS = Quality System
QSA = Quality System Assessment
RQAM = Regional Quality Assurance Manager
RQAO = Regional Quality Assurance Officer
RQC = Regional Quality Council
SDWA = Safe Drinking Water Act
TMDL = Total Maximum Daily Load
UFP = Uniform Federal Policy
WAM = Work Assignment Manager
Environmental Assessment &
Innovations Division (EAID)
RQAO
Serves as EAID QA Coordinator
Facilitates development of & updates to EAID QMP
Provides QA tech assistance to Mgrs, QACs & Staff
Reviews QAPPs for EAID
Administers the SDWA & NPDES PT Studies
Reviews and certifies DW laboratories
Participates in QSAs
VServes as DMRQA Evaluation Study Coordinator
OASQA/Quality Assurance Staff
Works w/RQC to develop QA/QC policies & procedures
Reviews QAPPs for compliance to EPA QA/R-5 & UFP-QAPP
Assists RQAM w/external QMP reviews
Participates in internal QSAs
Provides QA training
Provides technical assistance to QACs, PMs/POs, et al.
Program Managers
Serves as focal lead on a specific environmental
program (i.e., TMDL, enforcement, etc.)
Ensures data for environmental program meets
QA requirements of EPA NPO, R3 QMP &
Division/Program Office QMP
Cooperates w/QA reviews
Ensures audit recommendations are completed
V^ldentifies & reports QA training needs to QAC
Project Managers / Project Officers
Works with QA Coordinators and/or appropriate R3 QA
personnel (i.e., RQAM, RQAO, OASQA) to ensure
appropriate QA requirements are included in all
internal and external projects
Ensures extramural agreement holders comply w/EPA
QA requirements
V >
State & Local Governments,
Cooperative Agreements, lAGs,
Grantees, and Contractors
Implements QA requirements specified in
EPA 5360.1 A2, R3 QMP & Division/Program
QMPs
July 2008
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Figure 4
RFC Process
Handle outside of
RFC process or
notify sender that
it's not an RFC.
- Determine Info Owner and
Assign Case Manager & Tracking
Number.
- Create database entry.
- Notify: 1-sender of receipt; 2-
IQG Community, w/ opportunity to
participate.
- Post to Web site.
- Notify OMB.
Identify Congressional or
"other" outside interests.
NOTES:
E-mail transmission to OEMO should include a document link to the
IQG database, to provide access to items 1-5 below, and also a statement
of the action recommended by Quality Staff - whether review and concur
for OMB review or final signature, or sign for OEI ownership.
(1) submitter of RFC.
(2) summary of the request- specific issues being challenged,
which quality "concept" is being challenging (integrity,
objectivity, utility, reproducibility, influential designation, etc.)
- and response addressed to each issue.
(3) which Program/Region is the EPA Lead for responding to
the RFC.
(4) statement of any major, precedent-setting policy issues for
OEI or EPA overall with regard to Quality, Science, legal, etc.,
that AA/CIO should know before approval.
(5) original RFC document.
Transmission to OMB should include summary information from the
IQG tracking database along with draft to be reviewed. (Copy RFC
information from database, paste into word processing file, delete any
"EPA-only" information in "Notes" section, save the info as Word or
WordPerfect and attach to email.)
Initial Scoping Meeting scheduled by
IQG Officer, Information Owner:
staff/manager involved, OEI Case
Manager, OGC, other interested
programs/regions.
Determine whether
Agency will address
orrections requeste
Prepare draft "no action"
response to submitter.
Prepare draft response with
explanation of corrections to be made.
OGC and other interested programs/regions
review and approve draft response.
OEI reviews and approves draft
response prior to submittal to OMB.
Make changes as
requested.
Quality staff submits draft response
to OMB for review and approval.
OMB responds to Quality Staff with
requested changes or approval.
All approvals in place;
information owner sends
response to submitter.
Final response posted to IQG Web
site. All database entries completed
and corrective actions noted for
follow-up if necessary.
-------
Figure 5
RFR Process
Notify
Handle outside of
RFR process or
notify sender that
it's not an RFR.
- Determine Info Owner and
Assign Case Manager
-Tracking Number is RFC # w/ 'A'.
- Create database entry.
- Notify: 1 -sender of receipt;
2-IQG Community (offer
to participate.)
- Post to Web site.
- Notify OMB.
Identify Congressional or
"other" outside interests.
Is there conflict of interest
for any panel member?
Information owner develops
recommendation for response.w/
corrective action, if applicable.
Pre-brief panel members w/ options
and recommendation.
yes
Will RFR
appeal be
nsidered?
1
?
Develop briefing
summary & pre-brief
panel members to
obtain decision of
whether to consider
appeal.
Designate
replacement panel
member.
Check w/ OMB for any concerns
Convene panel (in person or telecon-
ference) to reach decision on response.
Panel appoints steward for corrective
action, if applicable.
Quality staff submits draft response
to OMB for review and approval.
OMB responds to Quality Staff with
requested changes or approval.
no
Prepare draft "no action" response for
Panel Chair to send to submitter.
RFR is closed.
Prepare draft response based on Panel
decisions; obtain Panel approval of draft.
Return edits to panel for
review and approval.
NOTE:
Transmission to OMB should include
summary information from the IQG
tracking database along with draft to be
reviewed.
Review requested edits.
Panel Chair and Quality
Staff make changes as
requested, information
owner involved if
warranted.
All approvals in place; Panel
Chair sends response to
submitter.
Final response posted to IQG Web
site. All database entries completed
and corrective actions noted for
follow-up if necessary.
Corrective actions completed.
Submitter and panel members
notified.
RFR closed.
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EPA Region III Quality Management Plan October 2008
Appendix A
Region III Quality Assurance Requirements for Grants and Cooperative Agreements
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EPA Region III Quality Management Plan October 2008
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
REGION III
1650 Arch Street
Philadelphia, Pennsylvania 19103-2029
REGION III QUALITY ASSURANCE REQUIREMENTS FOR
GRANTS AND COOPERATIVE AGREEMENTS
November 7, 2000
Quality Management Plan (QMP) Requirement
This QA requirement applies to all grants, cooperative agreements, contracts and interagency
agreements that involve the use of environmental data. Environmental data is defined as direct
measurements of environmental conditions or releases, such as sample collection and analysis.
Environmental data also includes data collected from secondary sources of information, such as
computer databases, computer models, literature files and historical databases. This data may
be used for a variety of purposes, such as characterization of ecological effects, the health of
human populations or the performance of environmental technology.
In accordance with 40 CFR 30.54 and 31.45, the recipient must develop and implement quality
assurance policies and practices that are sufficient to produce data of adequate quality to meet
program objectives. These policies and practices must be documented in a Quality
Management Plan (QMP). The QMP should be prepared in accordance with EPA QA/R-2:
EPA Requirements for Quality Management Plans. EPA QA/R-2 replaces EPA guidance
document QAMS-004/80. The recipient's QMP should be reviewed and updated annually as
needed.
Should there be multiple programs involved in a grant, cooperative agreement or interagency
agreement, at the recipient's discretion, they may submit one of the following:
a. A single QMP covering all of the programs in the grant or agreement or
b. A separate QMP for each program receiving the grant or agreement funds.
For certain grants and agreements, the EPA Project Officer may allow the recipient to submit a
combined Quality Management Plan/Quality Assurance Project Plan (QMP/QAPP). The
minimum EPA requirements for a Quality Management Plan and a Quality Assurance Project
Plan must be included in the combined QMP/QAPP.
The QMP or combined QMP/QAPP must be submitted to the EPA Project Officer at least 45
days prior to the initiation of data collection or data compilation. Prior to environmental data
collection or data compilation, the QMP or combined QMP/QAPP must be approved by the
EPA Regional Quality Assurance Manager.
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EPA Region III Quality Management Plan October 2008
Quality Assurance Project Plan (QAPP) Requirement
This QA requirement applies to all grants, cooperative agreements, contracts and interagency
agreements that involve the use of environmental data. Environmental data is defined as direct
measurements of environmental conditions or releases, such as sample collection and analysis.
Environmental data also includes data collected from secondary sources of information, such as
computer databases, computer models, literature files and historical databases. This data may
be used for a variety of purposes, such as characterization of ecological effects, the health of
human populations or the performance of environmental technology.
In accordance with 40 CFR 30.54 and 31.45, the recipient must develop and implement quality
assurance and quality control procedures, specifications and documentation that are sufficient to
produce data of adequate quality to meet project objectives. The Quality Assurance Project
Plan (QAPP) is the document that provides comprehensive details about the quality
assurance/quality control requirements and technical activities that must be implemented to
ensure that project objectives are met. The QAPP should be prepared in accordance with EPA
QA/R-5: EPA Requirements for Quality Assurance Project Plans. EPA QA/R-5 replaces EPA
QAMS 005/80.
The QAPP must be submitted to the EPA Project Officer at least 30 days prior to the initiation
of data collection or data compilation.
Prior to environmental data collection or data compilation, the QAPP must be approved by the
EPA Project Officer. When the recipient is delegating the responsibility for an environmental
data collection or data compilation activity to another organization, the EPA Regional Quality
Assurance Manager may allow the recipient to review and approve that organization's QAPP.
QA Requirement for Lead Grants (Combined QMP/QAPP)
For lead grants, the recipient must develop a combined QMP/QAPP that meets the requirements
found in the Region III Lead Program Quality Assurance Project Plan Guidance. A copy of this
guidance document can be obtained from the Region III Hotline. The hotline number is 1 (800)
438-2474. The combined QMP/QAPP must be submitted to the EPA Project Officer at least 30
days prior to the initiation of data collection or data compilation. Prior to environmental data
collection or data compilation, the combined Lead QMP/QAPP must be approved by the EPA
Project Officer and the Land and Chemicals Division (formerly the Waste and Chemicals
Management Division) QA Coordinator.
QA Requirement for Brownfields Cooperative Agreements (Combined QMP/QAPP)
For cooperative agreements awarded for Brownfields' projects, the recipient must develop QA
documents that meet the requirements found in 40 CFR Part 30, Subpart O and the US EPA
Quality Assurance Guidance for Conducting Brownfields Site Assessments. A copy of the US
EPA Quality Assurance Guidance for Conducting Brownfields Site Assessments can be
downloaded from the Internet at http://www.epa.gov/swerosps/bf/pdf/bfqag4.pdf.
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EPA Region III Quality Management Plan October 2008
In accordance with 40 CFR Part 30, Subpart O, the recipient must develop and implement
quality assurance policies and practices that are sufficient to produce data of adequate quality to
meet program objectives. Phase I environmental site assessments are non-intrusive, desktop
studies which must be conducted in accordance with the most recent version of the American
Society for Testing and Materials (ASTM) Practice El527 (Standard Practice for
Environmental Site Assessments: Phase I Environmental Site Assessment Process). El527
identifies the practices that constitute all appropriate inquiry into the previous ownership and
uses of the property consistent with good commercial or customary practice. Upon completion
of the Phase I assessment, the recipient must submit a copy of the Phase I Report to the EPA
Brownfields Project Officer or designated EPA Brownfields Project Representative.
If the EPA Brownfields Project Officer or designated EPA Brownfields Project Representative
authorizes the initiation of a Phase II assessment, the recipient must prepare a combined
QMP/QAPP. This combined QMP/QAPP must be prepared in accordance with the U.S. EPA
Region III Generic Quality Assurance Project Plan (QAPP) Template. A copy of the US EPA
Region III Generic Quality Assurance Project Plan Template can be obtained from the EPA
Brownfields Project Officer, designated EPA Brownfields Project Representative or the
Regional Quality Assurance Manager. At least 30 days before the initiation of the Phase II
assessment, the recipient must submit the generic QAPP to the EPA Brownfields Project Officer
or designated EPA Brownfields Project Representative. The EPA Brownfields Project Officer
or designated EPA Brownfields Project Representative must approve the recipient's generic
QAPP before the Phase II assessment begins.
In addition, at least 30 days before the initiation of any site sampling and analysis investigation,
the recipient must submit a site-specific Sampling and Analysis Plan. This site-specific
Sampling and Analysis Plan must meet the requirements found in the U.S. EPA Region III
Site-Specific Sampling and Analysis Plan Template. A copy of the US EPA Region III Site-
Specific Sampling and Analysis Plan Template can be obtained from the EPA Brownfields
Project Officer, designated EPA Brownfields Project Representative or the Regional Quality
Assurance Manager. Before sampling and analysis begins, the site-specific Sampling and
Analysis Plan must be approved by the EPA Brownfields Project Officer or designated EPA
Brownfields Project Representative.
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EPA Region III Quality Management Plan October 2008
Appendix B
Region III QA Review Form for Contract Actions
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EPA Region III Quality Management Plan October 2008
APPENDIX 46.1D U.S. EPA QUALITY ASSURANCE REVIEW FORM
FOR CONTRACT ACTIONS
**** Modified for Region III ****
I. General Information
a. Vehicle Type:
[ ] Solicitation/Sole Source
[ ] Delivery Order/Work Assignment /Task Order
(SOW #: and Contract #:)
b. Descriptive Title:
c. Sponsoring Organization (e.g., Branch, Division, Office, etc.):
d. Project Duration:
e. Is this a new [ ] or continuation of an existing [ ] project?
II. Scope of Work
[For example activities, see www.epa.gov/quality/examples.html]
a. Does the work involve: Yes No
- the collection, generation, use and/or reporting of environmental data? [ ] [ ]
(Environmental data are defined as any measurements or information that
Describe environmental processes, location, or conditions; ecological or
health effects and consequences; or the performance of environmental
technology. For EPA, environmental data include information collected
directly from measurements, produced from models, and compiled from
other sources such as data bases or the literature.)
- design, construction, and/or operation of environmental technologies? [ ] [ ]
- development and/or use of models? [ ] [ ]
- other activities that need quality assurance or quality control [ ] [ ]
requirements as identified in your organization's Quality Management
Plan? If yes, list: .
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EPA Region III Quality Management Plan October 2008
If all answers are No, skip Section III and complete Section IV.
b. Estimate of percentage of costs or level-of-effort allocated to the activities identified above:
III. Quality-Related Requirements
[Where applicable, reference a specific section of the Statement of Work.]
a. For Solicitations Only [complete (b) - (f) below, as well]
1. Insert the percentage of technical evaluation points assigned to offerer's quality system
documentation, or P/F if the evaluation is pass/fail:
2. List any quality standards (from your organization's Quality Management Plan) that you will
use in lieu of, or in addition to, Specifications and Guidelines for Quality Systems for
Environmental Data Collection and Environmental Technology Programs (ANSI/ASQC
E4).
Title: EPA Requirements for Quality Management Plans
Numbering: EPA QA/R-2
Date: March 2001
Requirements (Tailoring): Submit QMP to RQAM for review & approval.
Prior to the initiation of environmental data activities, the contractor's QMP
and QAPP must be approved. The recipient's QMP shall be reviewed and
updated annually, or more frequently as needed.
Title: EPA Requirements for Quality Assurance Project Plans
Numbering: EPA QA/R-5
Date: March 2001
Requirements (Tailoring): Submit QAPP to Project Officer for review &
approval. Prior to the initiation of environmental data activities, the
contractor's QMP and QAPP must be approved. QAPPs that are developed for
multiple projects and/or span over one year shall be reviewed and updated at
least annually.
Title: Region III Quality Assurance Requirements for Grants and Cooperative
Agreements
Numbering:
Date: November 7. 2000
Requirements (Tailoring):_
b. QA Documentation Options: [For solicitations, complete items 1-4; for all actions other than
solicitations, complete items 3-4. All documentation specified under "Other "must be defined in
your organization's Quality Management Plan and be consistent with requirements defined in
EPA Manual 5360 Al. For items checked under #2, there must be adequate information in the
SOW for the offer or to develop this documentation.]
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EPA Region III Quality Management Plan October 2008
Before Award Documentation1
1. Documentation of an organization's Quality System: Either [ ] QMP developed in
accordance with R-2 or [ ] Other: .
Combined documentation of an organization's Quality System and application of QA
and QC to the single project covered by contract: Either developed in accordance with [ ]
R-2 and R-5 or [ ] Other:
2. Programmatic QA Project Plan: Either developed in accordance with R5 or [ ] Other:_
Application of QA and QC activities to the single project covered by contract:
Either [ ]QA Project Plan developed in accordance with R-5 or [ ] Other:
Not applicable.
After Award Documentation1
3. Documentation of an organization's Quality System: Either [ ] QMP developed
in accordance with R-2 or [ ] Other:
Combined documentation of an organization's Quality System and application of
QA and QC to the single project covered by the contract: Either developed in accordance
with [ ] R-2 and R-5 or [ ] Other:
_ Not applicable.
Documentation of the application of QA and QC activities to applicable
project(s): Either developed in accordance with [ ] R-5; [ ] A supplement to the
following Programmatic QA Project Plan ; or [ ]Other:
_ Programmatic QA Project Plan with supplements for each specific project:
Developed in accordance with:
_ Existing documentation of the application of QA and QC activities will be used:
Either [ JDocumentation developed pre-award; [ ] Documentation will be
QMP refers to a Quality Management Plan. Programmatic QA Project Plan refers to a QA Project Plan that would
cover multiple projects with similar activities. R-2 refers to EPA Requirements for Quality Management Plans (QA/R-2)
(EPA/240/B-01/002, 03/20/01) and R-5 refers to EPA Requirements for Quality Assurance Project Plans (QA/R-5)
(EPA/240/B-01/003, 03/20/01) - copies of these documents are available at www.epa.gov/quality.
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EPA Region III Quality Management Plan October 2008
identified in individual Statements of Work or [ ] Documentation identified in
Section of the Statement of Work.
c. Reports: Are quality reports or reports containing quality assurance information (for example,
status of quality system implementation, review of a quality system, quality control data, etc.)
required? [X]Yes [ ] No
If yes, identify the required reports and the time frame for submission:
Indication of annual review and update of QMP and/or QAPP(s) shall be reported in
the contractor's annual report of performance.
d. Assessments: Select all quality assessments that will be performed either pre-award or post-
award:
Pre- Post-
Award Award
- On-site evaluation of offerer's/contractor's facility [ ] [ ]
- Assessments of the offerer's/contractor's Quality System [ ] [X]
(e.g., quality system audits, management system reviews, etc.)
- Project-specific assessments (e.g., technical systems audits, [ ] [ X ]
surveillance, performance evaluations, data quality assessments.
peer reviews, readiness reviews)
For each assessment, specify type, date to perform, and who will perform it (if known):
- On-Site Evaluation - To be performed by the CO/PO with the assistance of other qualified
EPA personnel as requested, annually, or more frequently if deemed necessary.
- Quality System Assessment - To be performed by the CO/PO with the assistance of other
qualified EPA personnel as requested, annually, or more frequently if deemed necessary.
- Project-Specific Assessments - To be performed by the CORs (the Work Assignment
Managers) on a routine basis for all sites/projects that each COR manages. Annually, the
CORs will also prepare Performance Evaluations for each Site/Project that received
Contractor support. These evaluations will be provided to the PO to be included in the
Contractor's Annual Performance Evaluation.
e. Procedures to Update Documentation: Identify any procedures/requirements for updating EPA-
approved quality-related documentation:
The recipient's QMP shall be reviewed and updated annually, or more frequently as
needed. QAPPs that are developed for multiple projects and/or span over one year shall be
reviewed and updated at least annually. Minor organizational and/or policy changes shall be
reported to EPA per requirements in III.c. above.
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f. Other Requirements: Identify any other pertinent quality-related requirements (as identified in
your organization's Quality Management Plan):
Prior to the initiation of environmental data activities, the contractor's QMP must be
approved by the ROAM, the QAPP must be approved by the Project Officer.
IV. Approvals
The signatures below verify that the Statement of Work has been reviewed to ascertain if
quality assurance or quality control activities are needed and that the appropriate quality
requirements have been established.
Contracting Officer's Representative Date Quality Assurance Manager Date
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EPA Region III Quality Management Plan October 2008
Appendix C
US EPA Region III Quality Management Plan Review Checklist
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EPA Region III Quality Management Plan
October 2008
US EPA REGION III
QUALITY MANAGEMENT PLAN
REVIEW CHECKLIST
Organization:
EPA
Organization:
EPA Program:
Contact:
EPA
Contact:
EPA Contract/Grant/lAG Number:
Phone
Number:
Phone
Number:
Reviewer:
Date
Reviewed:
Reviewer
Organization:
Check
One:
New
Plan:
Revised
Plan:
Phone
Number:
Response to
Comments:
Recommendation:
Acceptable:
Acceptable
w/comments:
Unacceptable
w/comments:
Key: A=Acceptable; U=Unacceptable; NI=Not Included; NA=Not Applicable
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October 2008
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QUALITY MANAGEMENT PLAN
REVIEW CHECKLIST
MANAGEMENT AND ORGANIZATION
1. Is there an approval page for signatures of senior managers,
senior line management (as appropriate) and the QA manager?
2. Has management established and implemented a quality
policy to ensure that the environmental program produces the
type and quality of results needed and expected?
2a. Does the policy discuss the importance of QA/QC activities
and why?
2b. Does the policy include general objectives and goals of the
quality system?
2c. Does management provide adequate resources and assign
sufficient authority and independence to staff to enable them to
plan, implement, assess and improve the organization's quality
system?
3. Is there an organizational chart that identifies all relevant
organizations, functional responsibilities, levels of accountability
and authority, and lines of communication?
4. Does the organizational chart document the independence of
the QA Manager from the groups generating environmental
data?
5. Is there a discussion of the responsibilities and authorities of
the QA Manager? Does the QA Manager report to senior
management on quality issues?
6. Is there a discussion of the technical activities or programs
that are supported by the quality system?
6a. Does the plan discuss where oversight of delegated,
contracted, or other extramural programs is needed?
6b. Does the plan identify where internal coordination of QA
and QC activities among organizations is needed?
7. Does management ensure that the applicable elements of the
quality system are understood and implemented in the
environmental program(s) under their authority?
A
U
Nl
NA
SECTION
COMMENTS
Key: A=Acceptable; U=Unacceptable; NI=Not Included; NA=Not Applicable
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QUALITY MANAGEMENT PLAN
REVIEW CHECKLIST
8. Does the document describe the process for resolving
disputes?
9. Does the document state that when physical changes in the
organization and/or changes in policy occur, the QMP will be
updated to reflect this information?
QUALITY SYSTEM AND DESCRIPTION
1 . Does the document include a description of the quality
system?
1a. Does the document describe the principal quality system
components (e.g., quality system documentation, annual
reviews and planning, management assessments, training,
systematic planning, project specific quality documentation,
project & data assessments) and how they are implemented?
1b. Is there a list of tools for implementing each component
(e.g., QMPs, Quality Systems Audits, Training Plans, QA
Project Plans, Data Assessment)?
1c. Does the description of components includes the
responsibilities of management and staff?
PERSONNEL QUALIFICATIONS AND TRAINING
1. Does the document contain a policy statement regarding QA
training for management and staff?
2. Is there a process for identifying, ensuring, and documenting
that personnel have and maintain the appropriate knowledge;
skill; and statutory, regulatory, professional or other
certifications, accreditations, licenses?
3. Does the document describe the process for identifying the
need for quality-related retraining based on changing
requirements?
4. Does the document include roles, responsibilities, and
authorities in its description of the above processes?
A
A
U
U
Nl
Nl
NA
NA
SECTION
SECTION
COMMENTS
COMMENTS
Key: A=Acceptable; U=Unacceptable; NI=Not Included; NA=Not Applicable
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QUALITY MANAGEMENT PLAN
REVIEW CHECKLIST
PROCUREMENT OF ITEMS AND SERVICES
1. Does the document describe or reference the process for
reviewing and approving all extramural agreements (grants,
cooperative agreements and contracts)?
1a. Does the review process ensure documents are complete
and accurate?
1b. Does the review process ensure agreements clearly
describe the item or service needed?
1c. Does the review process ensure agreements describe the
associated technical and quality requirements?
1d. Does the review process ensure agreements describe the
quality system elements for which the supplier is responsible?
1e. Does the review process ensure that the supplier's
conformance to the customer's requirements will be verified?
2. Does the document describe the process to ensure procured
items and services are acceptable?
3. Does the document describe the process for review and
approval of suppliers' quality-related documentation (e.g., QA
Project Plans and QMPs)?
4. Does the document describe the process to ensure EPA
extramural agreement policies are satisfied?
5. Are the roles, responsibilities, and authorities of managers
and staff included in the description of the above processes?
A
U
Nl
NA
SECTION
COMMENTS
Key: A=Acceptable; U=Unacceptable; NI=Not Included; NA=Not Applicable
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QUALITY MANAGEMENT PLAN
REVIEW CHECKLIST
DOCUMENTS AND RECORDS
1. Does the document describe the process for identifying
quality-related documents (i.e., SOPs, QAPPs, MSRs, etc.) and
other project-related records (both paper and electronic)
requiring control?
2. Does the document describe the process for preparing,
reviewing, approving, issuing, using, authenticating, and revising
documents and records?
3. Does the document describe the process for ensuring that
records and documents accurately reflect completed work?
4. Does the document describe the process for maintaining
documents and records; including transmittal, distribution,
retention, access, preservation, traceability, retrieval, removal of
obsolete documentation, and disposition?
4a. Have retention times for records been established based
on contractual and statutory requirements? If not, has
management specified appropriate retention times?
4b. While in storage, are records protected from damage, loss
and deterioration?
5. Does the document describe the process for ensuring
documents and records comply with all applicable statutory,
regulatory, and Agency policies?
6. When evidentiary records are involved, are appropriate chain
of custody and confidentiality procedures established and
implemented?
7. Are the roles, responsibilities, and authorities of managers
and staff included in the description of the above processes?
A
U
Nl
NA
SECTION
COMMENTS
Key: A=Acceptable; U=Unacceptable; NI=Not Included; NA=Not Applicable
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QUALITY MANAGEMENT PLAN
REVIEW CHECKLIST
COMPUTER HARDWARE AND SOFTWARE
1. Does the document describe the process for developing,
installing, testing, using, maintaining, controlling, and
documenting computer hardware/software used in
environmental programs to ensure that it meets user
requirements?
2. Does the document describe the process for assessing and
documenting the impact of changes to user requirements and/or
the hardware and software on performance?
3. Does the document describe the process for evaluating
purchased hardware and software to ensure it meets user or
contractual requirements?
4. Does the document describe the process for ensuring that
data and information produced from or collected by computers
meet applicable information resource requirements and
standards?
5. Are the roles, responsibilities, and authorities of managers
and staff included in the description of the above processes?
PLANNING
1. Does the document describe the process for planning
environmental data operations using a systematic planning
process, such as EPA's Data Quality Objectives Process?
1a. Does the planning process include identification and
involvement of all project personnel, scientific experts,
customers and suppliers?
1 b. Does the planning process include a description of the
project goal, objectives, and questions/issues to be
addressed?
A
A
U
U
Nl
Nl
NA
NA
SECTION
SECTION
COMMENTS
COMMENTS
Key: A=Acceptable; U=Unacceptable; NI=Not Included; NA=Not Applicable
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QUALITY MANAGEMENT PLAN
REVIEW CHECKLIST
1c. Does the planning process include identification of project
schedule, resources, milestones, and any applicable
requirements?
1d. Does the planning process include identification of the type
and quantity of data needed and how the data will be used to
support the project's objectives?
1e. Does the planning process include specification of
performance criteria for measuring quality?
1f. Does the planning process include specification of needed
QA and QC activities to assess the quality performance
criteria?
1g. Does the planning process include a description of how,
when, and where the data will be obtained (including existing
data) and identification of any constraints on data collection?
1h. Does the planning process include a description of how
the acquired data will be analyzed, evaluated, and assessed
against its intended use and the quality performance criteria?
2. Does the document state that the results of the systematic
planning process will be documented in a Quality Assurance
Project Plan, or equivalent?
3. Does the document describe the process for developing,
reviewing, approving, implementing, and revising QA Project
Plans?
4. Does the document state that an environmental data
operation cannot begin until there is an approved Quality
Assurance Project Plan, or equivalent?
5. Does the document describe the process for evaluating and
qualifying previously collected data and other information that
will be used to make project decisions?
Key: A=Acceptable; U=Unacceptable; NI=Not Included; NA=Not Applicable
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QUALITY MANAGEMENT PLAN
REVIEW CHECKLIST
6. Are the roles, responsibilities, and authorities of managers
and staff included in the description of the above processes?
IMPLEMENTATION OF WORK PROCESSES
1. Does the document state that work shall be performed
according to approved planning and technical documents?
2. Does the document describe the process for ensuring that
work is performed according to approved planning and technical
documents?
3. Does the document list the source and title of Standard
Operating Procedures (SOPs) that are being used for routine,
standardized and critical operations?
3a. Does the document describe the process for preparation,
review, approval, revision, and withdrawal of SOPs?
3b. Does the document describe the policy for use of these
procedures?
4. Does the document describe the process for controlling and
documenting the release, change, and use of these SOPs?
4a. Does the process include a description of required
approvals?
4b. Does the process include removal of obsolete
documentation from work areas?
4c. Does the process include verification that the changes are
made as prescribed?
5. Are the roles, responsibilities, and authorities of managers
and staff included in the description of the above processes?
ASSESSMENT AND RESPONSE
1. Does the document describe the process for assessing the
adequacy of the quality system? Does the review occur at least
annually?
A
A
U
U
Nl
Nl
NA
NA
SECTION
SECTION
COMMENTS
COMMENTS
Key: A=Acceptable; U=Unacceptable; NI=Not Included; NA=Not Applicable
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QUALITY MANAGEMENT PLAN
REVIEW CHECKLIST
2. Does the document describe the process for planning,
implementing and documenting assessments and reporting
results to management?
2a. Does the process include selecting an assessment tool
(e.g., quality system audits, management system reviews,
peer reviews, technical reviews, performance evaluations,
data quality assessments, readiness reviews, technical
systems audits, and surveillance), the expected frequency of
their application to environmental programs, and the roles and
responsibilities of assessors?
2b. Does the process include determining the level of
competence, experience and training needed for assessment
personnel?
2c. Does the process include ensuring that personnel have no
real or perceived conflict of interest, and have no direct
involvement or responsibility for the work being assessed?
2d. Does the process include ensuring that personnel
conducting assessments have sufficient authority, access to
programs and managers; access to documents and records;
and organizational freedom to identify problems and
noteworthy practices, propose recommendations for resolving
problems, and/or independently confirm implementation &
effectiveness of solutions ?
3. Does the document describe the process for management's
review of, and response to, findings?
4. Does the document describe the process for identifying how
and when corrective actions are to be taken in response to the
findings of the assessment?
4a. Does the process include ensuring corrective actions are
made promptly?
Key: A=Acceptable; U=Unacceptable; NI=Not Included; NA=Not Applicable
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QUALITY MANAGEMENT PLAN
REVIEW CHECKLIST
4b. Does the process include confirming the implementation
and effectiveness of any corrective action?
4c. Does the process include documenting actions?
5. Does the document describe the process for addressing
disputes encountered as a result of assessments?
6. Are the roles, responsibilities, and authorities of managers
and staff included in the description of the above processes?
QUALITY IMPROVEMENT
1. Does the document describe the process for ensuring that
conditions adverse to quality are prevented, promptly identified
and corrected; and that actions are taken to prevent
reoccurrence?
1a. Are these actions documented and tracked to closure?
2. Does the document describe the process for encouraging staff
to establish communication between customers and suppliers,
identify process improvement opportunities, and identify and
propose solutions for problems?
3. Are the roles, responsibilities, and authorities of managers
and staff included in the description of the above processes?
A
U
Nl
NA
SECTION
COMMENTS
Key: A=Acceptable; U=Unacceptable; NI=Not Included; NA=Not Applicable
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Appendix D
Region III QAPP Review Checklist
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Document Number:
Site Name:
Document Title:
Account Number:
Revision: 0
Date: January 27, 2006
REGION III QAPP Review Checklist
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Date: January 27, 2006
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Revision: 0
Date: January 27, 2006
IA = Included and Adequate for Data Quality ID = Included and Inadequate for Data Quality Nl = Not included NA = Not Applicable
Reference
Code
(Section #)
Elements & Required Information
IA
IU
Nl
NA
Location of Element
in Submitted
Document
(Section #, Table #,
figure #, etc)
COMMENTS
PROJECT MANAGEMENT
1(A1)
1 (A2)
1 (A3)
1 (A4)
Title & Approval Page
Includes title of plan
Includes name of the organizations
Includes names, titles, signatures of appropriate
officials and their approval dates
Table of Contents
(Lists sections, figures, tables, references, and
appendices)
Effective Document Control Format
Distribution List
(Lists all the individuals and their organizations who
will receive copies of the approved QAPP and any
subsequent revisions.)
Project Organization
Identifies key individuals or organizations
participating in the project with their responsibilities
(e.g., data users, decision-makers, project QA
manager, subcontractors, etc.)
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IA = Included and Adequate for Data Quality ID = Included and Inadequate for Data Quality Nl = Not included NA = Not Applicable
Reference
Code
(Section #)
Elements & Required Information
IA
IU
Nl
NA
Location of Element
in Submitted
Document
(Section #, Table #,
figure #, etc)
COMMENTS
PROJECT MANAGEMENT
1 (A5)
Identifies/Describes individual(s) responsible for
overall QA/AC (Project QA manager is independent
of the data generating unit)
Identifies individual(s) responsible for sampling
operations and sampling QC
Identifies individual(s) responsible for data
processing and data processing QC
Identifies organization(s) involved with data analysis
Identifies individual(s) responsible for data validation
(needs to be independent of data
generator/laboratory)
Project Organization Chart(s) [Shows lines of
authority and reporting responsibilities, includes
contractors and subcontractors]. Includes EPA's
role and other stakeholders/decision makers.
Site Background
Includes a list of the known and suspected
contaminants in each medium and estimates of their
concentration, variability, distribution, and location.
Includes the site's physical and chemical
characteristics that influence migration and
associated human, environmental and physical
targets.
Includes a conceptual site model and exposure
pathways
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Reference
Code
(Section #)
Elements & Required Information
IA
IU
Nl
NA
Location of Element
in Submitted
Document
(Section #, Table #,
figure #, etc)
COMMENTS
PROJECT MANAGEMENT
1(A5)
2(Chap.1)
3
(Chap. 1)
4
(Chap. 1)
Includes a summary of the outcome and status of
any previous response(s) at the site, such as early
actions or previous data collection activities
Includes Site Maps (historical & present)
Problem Definition
Includes statement(s) of the decision(s) that will be
made based on the outcome of the field
investigation
Includes list of actions that will be taken toward
remediation or removal of the potential
contamination problem based on the outcome of the
field investigation
Includes the types of informational inputs needed for
decision (e.g., sampling, modeling, or a combination
of these approaches). If applicable, include
collection of previous data collection (identifying
sources).
Identifies Applicable technical quality standards or
criteria (e.g., ARARS, State standards, other federal
agency standards, action levels).
Includes specific action levels and the criteria for
choosing between alternative actions
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Reference
Code
(Section #)
Elements & Required Information
IA
IU
Nl
NA
Location of Element
in Submitted
Document
(Section #, Table #,
figure #, etc)
COMMENTS
PROJECT MANAGEMENT
1(A6)
4
(Chap. 3)
Includes a decision rule . an "jf...then...." statement
that defines the conditions that would cause the
decision maker to choose among alternative
courses of action. The decision rule should include
the decision, the actions, the parameter of interest
and the action level.
Project Description & Schedule
Provides a description of the work to be performed;
provides sufficient information as to the project's
goals and types of activities to be conducted
Includes special personnel and equipment
requirements that may indicate the complexity of the
project (particularly for any new or innovative
sampling or analytical technique being employed)
Includes Project Schedule Timeline (graphical or
tabular format). Includes start and completion dates
for all project activities (including quality assurance
assessments).
Includes procedure for notification of project
participants concerning schedule delays (identify job
function, org. name, personnel responsible for
providing and receiving such notification, and
personnel responsible for approving schedule
changes)
Includes discussion of resource and time
constraints, such as seasonal sampling restrictions
and considerations (if applicable)
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Reference
Code
(Section #)
Elements & Required Information
IA
IU
Nl
NA
Location of Element
in Submitted
Document
(Section #, Table #,
figure #, etc)
COMMENTS
PROJECT MANAGEMENT
1(A7)
Quality Objectives & Criteria
Lists measurement methods for each item of
necessary information (list chemical and/or
biological analytical methods). Specific tables may
be included here or under A7 and/or B4 of this
checklist. Tables need to include Project Action
limits, project quantitation limits and laboratory
detection limits.
Includes the range of anticipated concentrations of
the parameters of interest
Defines and evaluates the potential consequences
of decision errors (i.e., false positive error or false
negative error) near the action level.
Includes how sufficient data will be collected to
ensure that the proposed action limits are not
exceeded after remediation and/or removal of
contaminants of concern.
Describes when screening and definitive data2 will
be used to make site decisions. Also, defines
limitations on the use of screening data. For
screening data being used for site decisions, at least
10% must be confirmed by fixed laboratory.
Provides justification when not confirming.
For definition of screening and definitive data see reference 2.
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Reference
Code
(Section #)
Elements & Required Information
IA
IU
Nl
NA
Location of Element
in Submitted
Document
(Section #, Table #,
figure #, etc)
COMMENTS
PROJECT MANAGEMENT
Addresses Precision (quantitative measurement
performance criteria, QA/QC activities, and/or QC
checks/samples being used to determine acceptable
precision for each matrix, analytical parameter and
concentration level). Includes equations to be used
to calculate precision.
Addresses Accuracy (quantitative measurement
performance criteria, QA/QC activities, and/or QC
checks/samples being used to determine acceptable
accuracy/bias for each matrix, analytical parameter
and concentration level). Includes equations to be
used to calculate accuracy.
Addresses Representativeness (quantitative
measurement performance criteria, QA/QC activities
being used to determine representativeness for
each matrix, analytical parameter and concentration
level).
Addresses Comparability (quantitative measurement
performance criteria, QA/QC activities, and/or QC
checks/samples being used to determine
comparability for each matrix, analytical parameter
and concentration level). Sampling and analytical
procedures are consistent within and between data
sets.
Provides criteria for comparing oversight split
sampling, if applicable.
Provides Comparability criteria for field
screening/confirmatory results, if applicable.
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October 2008
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Reference
Code
(Section #)
Elements & Required Information
IA
IU
Nl
NA
Location of Element
in Submitted
Document
(Section #, Table #,
figure #, etc)
COMMENTS
PROJECT MANAGEMENT
1 (A8)
1 (A9)
Addresses Completeness. If applicable, includes a
list of critical samples. Includes equations to be
used to calculate completeness.
Includes a table with the project's QA objectives for
precision, accuracy and completeness. The QA
objectives should include requirements for "Total
system" variability and bias not just laboratory error
or criteria (Total system = sampling design error +
measurement error).
Special Training Requirements/Certification Listed
(Unique methods, Validators, Water Plans)
Lists or states how training is provided,
documented, and assured
Documentation and Records
Itemizes the information and records (field operation
records, laboratory records, data handling records)
that must be included in the data report package
and specifies the desired reporting format for hard
copy and electronic forms
Identifies any other records and documents
applicable to the project, such as audit reports,
interim progress reports, and final reports, that will
be produced. Includes electronic data from
instrumentation (tapes).
Specifies or references all applicable requirements
for the final disposition of records and documents,
including location and length of retention period.
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IA = Included and Adequate for Data Quality ID = Included and Inadequate for Data Quality Nl = Not included NA = Not Applicable
Reference
Code
(Section #)
Elements & Required Information
IA
IU
Nl
NA
Location of Element
in Submitted
Document
(Section #, Table #,
figure #, etc)
COMMENTS
PROJECT MANAGEMENT
States Revisions/updates to QAPP are every 3.5
years
MEASUREMENT/DATA ACQUISITION ELEMENTS
1(B1)
1 (B2)
Sample Design
Identifies Type (composite, grab, etc.) and number
of samples required. Table format recommended.
Provides justification for type and number of
samples; MDL rationale/impact. Identifies
Background samples (if applicable)
Sampling Process Design (Experimental Design)
[Describes the experimental design or data
collection design for the project]
Sample Locations and frequency (e.g. map)
Sample & Analysis Methods (General description)
Sample matrices
Classifies each measurement parameters as either
critical or needed for information only
Provides Appropriate validation study information;
for nonstandard situations
Sampling Methods Requirements
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IA = Included and Adequate for Data Quality ID = Included and Inadequate for Data Quality Nl = Not included NA = Not Applicable
Reference
Code
(Section #)
Elements & Required Information
IA
IU
Nl
NA
Location of Element
in Submitted
Document
(Section #, Table #,
figure #, etc)
COMMENTS
PROJECT MANAGEMENT
Identifies sample collection procedures and
methods (if referencing sampling, SOPs may be
attarhprl tn OAPP1
Describes filtering procedures, if applicable.
Describes sequencing of samples, if applicable
Describes homogenizing of samples, if applicable
Identifies support facilities
Identifies individuals for corrective action. Describe
decision/who's responsible and documentation
rpmiirprl
Includes Sampling SOP Modifications
Provides Cleaning & Decontamination Procedures
of Equipment/Sample Containers [Decontamination
Procedures includes acid, water, and solvent rinse
(methanol is preferred solvent)]; SOPs
Provides Sampling Containers, Volumes, Holding
Times, & Preservation Table
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Date: January 27, 2006
IA = Included and Adequate for Data Quality ID = Included and Inadequate for Data Quality Nl = Not included NA = Not Applicable
Reference
Code
(Section #)
Elements & Required Information
IA
IU
Nl
NA
Location of Element
in Submitted
Document
(Section #, Table #,
figure #, etc)
COMMENTS
PROJECT MANAGEMENT
1(B3)
Provides Field Sampling Equipment Calibration w/
table
Identifies Field Equipment Maintenance, Testing &
Inspection Requirements
Provides Inspection & Acceptance Requirements for
Supplies/Sample Containers
Sample Handling, Tracking & Custody
Requirements
Note: Laboratory QAP should included information
about laboratory sample handling and custody.
Provides Sample Handling, Tracking & Custody
SOPs with Sample Handling Flow Diagram (used for
multiple sampling events with multiple laboratories)
Provides Sample Collection Documentation
(includes form to track custody)
Provides Sample Container Label / Sample Tag
(include examples)
Identifies Field Notes (lists information to be entered
in field logbook)
Documents source of field reagents or supplies,
includes sample containers
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Date: January 27, 2006
IA = Included and Adequate for Data Quality ID = Included and Inadequate for Data Quality Nl = Not included NA = Not Applicable
Reference
Code
(Section #)
Elements & Required Information
IA
IU
Nl
NA
Location of Element
in Submitted
Document
(Section #, Table #,
figure #, etc)
COMMENTS
PROJECT MANAGEMENT
1(B4)
Includes procedures/forms for recording the location
& specific consideration associated with samples
Documents specific preservation method (including
temperature upon receipt)
Analytical Methods Requirements
Provides SOPs and validation information for
nonstandard methods
Provides 10% offsite laboratory confirmation for
screening methods
Identifies laboratory (ies)
Includes laboratory(ies) information (QA Manual,
SOPs, PE results, certifications)
[Use LQAP checklist ifLQAP submitted separately]
Identifies individuals responsible for corrective
action
Specifies needed laboratory turnaround time (if
important to the project schedule)
Provides Field Analytical Methods & SOPs (includes
modifications if applicable)
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IA = Included and Adequate for Data Quality ID = Included and Inadequate for Data Quality Nl = Not included NA = Not Applicable
Reference
Code
(Section #)
Elements & Required Information
IA
IU
Nl
NA
Location of Element
in Submitted
Document
(Section #, Table #,
figure #, etc)
COMMENTS
PROJECT MANAGEMENT
Provides Field Analytical Instrument Calibration
Provides Field Analytical Instrument/ Equipment
Maintenance Testing & Inspection Requirements
Identifies Field Analytical Inspection & Acceptance
Requirements for Supplies
Provides Fixed Lab Analytical Method Requirements
(include sub-sampling, preparation, cleanup, or
pvtrartinn mpthnrli/nrnrprlnrpO
Provides Fixed Lab Analytical Methods & SOPs
(includes modifications if applicable; includes
reporting limits, etc.)
[Use LQAP checklist if LQAP was submitted
separately]
Provides Fixed Lab Instrument Calibration
procedures
n /Q£> / DAP rh(*rkli
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October 2008
Revision: 0
Date: January 27, 2006
IA = Included and Adequate for Data Quality ID = Included and Inadequate for Data Quality Nl = Not included NA = Not Applicable
Reference
Code
(Section #)
Elements & Required Information
IA
IU
Nl
NA
Location of Element
in Submitted
Document
(Section #, Table #,
figure #, etc)
COMMENTS
PROJECT MANAGEMENT
1(B5)
1 (B6)
Quality Control Requirements (Identifies required
measurement QC checks for both the field and the
laboratory)
Includes Trip blank (1/cooler containing volatiles)
Includes Field blank (1 blank/matrix/day or 1
blank/20 samples/matrix, whichever is more
frequent)
Includes Rinsate/Equipment Blank (1
blank/matrix/day or 1 blank/20 samples/matrix,
whichever is more frequent)
Includes Temperature Blank (1/cooler)
Includes Field Duplicate (1 duplicate/20 samples)
Includes Matrix Spike/Matrix Spike Dup (1/20
samples/matrix)
Identifies acceptance criteria and corrective action
for QC procedures
Identifies Field Analytical QC (calibration check
samples), includes frequency and limits
Provides Fixed Laboratory QC procedures,
frequency and limits
[Use LQAP checklist if LQAP was submitted
separately]
Instrument/Equipment Testing, Inspection, and
Maintenance Requirements
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Date: January 27, 2006
IA = Included and Adequate for Data Quality ID = Included and Inadequate for Data Quality Nl = Not included NA = Not Applicable
Reference
Code
(Section #)
Elements & Required Information
IA
IU
Nl
NA
Location of Element
in Submitted
Document
(Section #, Table #,
figure #, etc)
COMMENTS
PROJECT MANAGEMENT
1(B7)
1 (B8)
Identifies acceptance testing of sampling and
measurement systems
Describes equipment preventative and corrective
maintenance
Notes availability and location of spare parts
Instrument Calibration and Frequency
Identifies equipment needing calibration and
frequency for such calibration
Identifies frequency of calibration verification or
continuing calibration
Notes required calibration standards and/or
equipment
Cites calibration records and manner traceable to
equipment
Inspection/Acceptance Requirements for Supplies
and Consumables
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Revision: 0
Date: January 27, 2006
IA = Included and Adequate for Data Quality ID = Included and Inadequate for Data Quality Nl = Not included NA = Not Applicable
Reference
Code
(Section #)
Elements & Required Information
IA
IU
Nl
NA
Location of Element
in Submitted
Document
(Section #, Table #,
figure #, etc)
COMMENTS
PROJECT MANAGEMENT
1(B9)
1 (A9,
B10)
States acceptance criteria for supplies and
consumables
Notes responsible individuals
Data Acquisition Requirements for Non-Direct
Measurements (Historical/Databases/Modeling)
Identifies types of data needed for non-
measurement sources (e.g., computer databases
and literature files), along with acceptance criteria
for their use
Describes any limitations of such data
Documents rationale for original collection of data
and its relevance to this project
Data Management
Can be included in separate Data Management Plan
Describes Data Recording (Describes standard
record-keeping and data storage and retrieval
rffniiirffmpmtO
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IA = Included and Adequate for Data Quality ID = Included and Inadequate for Data Quality Nl = Not included NA = Not Applicable
Reference
Code
(Section #)
Elements & Required Information
IA
IU
Nl
NA
Location of Element
in Submitted
Document
(Section #, Table #,
figure #, etc)
COMMENTS
PROJECT MANAGEMENT
Describes Data Validation (Details the process of
data validation; should address how the method,
instrument, or system preforms the function it is
intended to -consistently, reliably, and accurately
when generating the data)
Note: Part D addresses the overall project data
validation
Describes Data Transformation (Documents
Procedures)
Data transformation is the conversion of individual
data point values into related values or possibly
symbols using conversion formulas or a system for
replacement)
Note: Transformation and aberration of data for
statistical analysis should be outlined in element D3.
Describes Data Transmittal (Describes each data
transfer step and the procedures used to
characterize data transmittal error rates and to
minimize information loss in transmittal)
Describes Data Reduction - involves irreversible
reduction in the size of the data set and an
associated loss of detail. (For manual calculation,
includes an example of how raw data is reduced; for
automated data process, indicates how the raw data
are to be reduced with a well-defined audit trail, and
references specific software documentation)
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October 2008
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IA = Included and Adequate for Data Quality ID = Included and Inadequate for Data Quality Nl = Not included NA = Not Applicable
Reference
Code
(Section #)
Elements & Required Information
IA
IU
Nl
NA
Location of Element
in Submitted
Document
(Section #, Table #,
figure #, etc)
COMMENTS
PROJECT MANAGEMENT
Describes Data Analysis (includes an outline of the
proposed methodology with a more detailed
discussion included in final report)
Describes Data Tracking (describes procedures for
tracking the flow of data through the data processing
system)
Describes Data Storage and Retrieval (describes
procedures for data storage and retrieval including
security and time of retention included; includes
documentation of the complete control system;
discusses performance requirements of the data
processing system, including provisions for the
batch processing schedule and the data storage
facilities). Includes storage and retrieval of electronic
data (needs to be available upon EPA request)
ASSESSMENT/OVERSIGHT ELEMENTS
1(C1)
Assessments and Response Actions
Lists required number, frequency and type of
assessments, with approximate dates and names of
responsible personnel (assessments include but are
not limited to peer reviews, management systems
reviews, technical systems audits, performance
evaluations, and audits of data quality)
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October 2008
Revision: 0
Date: January 27, 2006
IA = Included and Adequate for Data Quality ID = Included and Inadequate for Data Quality Nl = Not included NA = Not Applicable
Reference
Code
(Section #)
Elements & Required Information
IA
IU
Nl
NA
Location of Element
in Submitted
Document
(Section #, Table #,
figure #, etc)
COMMENTS
PROJECT MANAGEMENT
1(C2)
Identifies individual(s) responsible for corrective
actions
Provides Feedback from performance audits (field
and laboratory)
Includes Schedule of audits
Reports to management
Identifies frequency and distribution of reports for
project status
Identifies frequency and distribution of reports for
results of performance evaluations and audits
Identifies frequency and distribution of reports for
results of periodic data quality assessments
Identifies frequency and distribution of reports for
changes in the QAPP
Identifies frequency and distribution of reports for
any significant QA problems indicating EPA is
nntifiprl immp>rliatp>l\/
Identifies frequency and distribution of reports for
preparers and recipients of reports
DATA VALIDATION AND USABILITY ELEMENTS
1 (D1)
Data Review
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October 2008
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Date: January 27, 2006
IA = Included and Adequate for Data Quality ID = Included and Inadequate for Data Quality Nl = Not included NA = Not Applicable
Reference
Code
(Section #)
Elements & Required Information
IA
IU
Nl
NA
Location of Element
in Submitted
Document
(Section #, Table #,
figure #, etc)
COMMENTS
PROJECT MANAGEMENT
1(D2)
5
6
7
1 (D3)
Describes the procedures being used to review field
and laboratory data to ensure that it meets
requirements specified in field and analytical SOPs.
Includes project-specific calculations or algorithms
Identifies issue resolution procedure and title(s) of
individual(s) responsible for issue resolution
Data Verification and Validation Methods
Describes process for data validation and
verification (provide SOPs or reference Region III
Modifications to National Functional Guidelines for
Data Review)
Identifies issue resolution procedure and title(s) of
individual(s) responsible for issue resolution
Identifies method for conveying these results to data
users
Data Quality Assessment
Describe the procedures used to evaluate the
uncertainty of data acquired during sampling and
analytical procedures.
Describes the procedures that will be used to
reconcile project results with DQOs.
Describes how the limitation on use of the data will
be reported.
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References
1. EPA Requirements for Quality Assurance Project Plans, EPA QA/R5, March 2001. Can be downloaded from the Internet at
http://www.epa.qov/QUALITY/qa docs.html.
2. Data Quality Objectives Process for Superfund: Interim Final Guidance (EPA, 1993)
3. Guidance on Systematic Planning using the Data Quality Objectives Process. EPA /240/B067001, February 2006. Can be downloaded from the Internet
at http://www.epa.gov/QUALITY/qa docs.html
4. Data Quality Objectives Process for Hazardous Waste Site Investigations, EPA QA/G-4HW, January 2000. Can be downloaded from the Internet at
http://www.epa.gov/QUALITY/qa docs.html
5. Region III Modifications to the National Functional Guidelines for Inorganic Data Review, April 1993.
http://www.epa.gov/regi on3/esc/OA/docs_dataval.htm
6. Region III Modifications to the National Functional Guidelines for Organic Data Review, November 1994.
http://www.epa.gov/region3/esc/QA/docs dataval.htm
7. Region III Innovative Approaches to Data Validation, June 1995. http://www.epa.gov/region3/esc/QA/docs dataval.htm
8. Region III Dioxin/Furan Data Validation Guidance, March, 1999. http://www.epa.gov/region3/esc/QA/docs dataval.htm
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EPA Region III Quality Management Plan October 2008
Appendix E
EPA Region III Pre-dissemination Review Document
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EPA Region III Quality Management Plan October 2008
EPA Region III
Information Quality Guidelines Pre-Dissemination Review
Overview
EPA issued its Information Quality Guidelines (IQG) in October 2002 in response to guidelines issued by OMB pursuant to the 2001
Information Quality Act.
EPA's IQG contain EPA's policy and procedural guidance for ensuring and maximizing the quality of information it disseminates.
The EPA IQG provide definitions for "information", "dissemination", "utility", "objectivity", "integrity" and others and should be
referred to for detailed information. The EPA IQG document is available on the IQG public web site at
http://www.epa.gov/quality/informationguidelines/index.html. Additional IQG documents and training materials for EPA staff are
available on the IQG intranet site at http://intranet.epa.gov/quality/informationguidelines/
A Pre-Dissemination review as defined in section 7 of the IQG is intended to insure that information EPA disseminates is of the
highest quality possible and meets standards for objectivity, utility and integrity. Any disseminated information not meeting these
standards can be subject to a "request for correction" (RFC) and its appeal, a "request for reconsideration" (RFR) by any person.
OEI has a formal process in place for the administration of RFCs and RFRs. Past and current RFCs and RFRs can be viewed on the
EPA website.
EPA issued its Pre-Dissemination Review Guidelines in 2006 to assist offices and regions in implementing their own pre-
dissemination review procedures. This document therefore serves as a basis for Region Ill's procedure for conducting pre-
dissemination reviews. Region III offices may expand upon the review procedure presented here.
Please note that EPA's pre-dissemination review guidelines provide non-binding internal policy and procedural guidance intended
solely for EPA management and stafr
Pre-Dissemination Review
One of the most important things to remember about conducting a pre-dissemination review is that it is not intended to consist solely
of a final review in the development of a product. Rather, it should be conducted throughout a product's development life cycle.
This document provides a checklist which can be used to document the results of pre-dissemination review during development.
Determine Eligibility
1. Determine if you need to conduct a pre-dissemination review using the IQG definitions of "information" and
"dissemination" (Steps 2 and 3 below and IQG Section 5.3). The Region III IQG officer can be consulted should you have
questions about whether the IQG apply (and thus a review is needed). Examples of non-applicability of the IQG are given
in IQG Section 5.4
2. Determine whether the product to be reviewed is information. "Information," generally includes any communication or
representation of knowledge such as facts or data, in any medium or form.
3. Determine whether the product will be disseminated by EPA. EPA disseminates information to the public when EPA
initiates or sponsors the distribution of information to the public.
4. If neither step 2 or 3 applies then no PDR is necessary at this time. Otherwise continue to step 5. Note that under certain
circumstances a product may become eligible for a review (e.g. EPA decides it would like to disseminate a report that had
been only available within EPA).
Determine whether quality is maximized and IQG quality criteria are met
5. Determine whether the product to be disseminated has maximized quality and has met the IQG criteria for utility,
objectivity and integrity. "Utility" refers to the usefulness of the information to the intended users. "Objectivity" focuses
on whether the disseminated information is being presented in an accurate, clear, complete, and unbiased manner, and as a
matter of substance, is accurate, reliable, and unbiased. "Integrity" refers to security, such as the protection of information
from unauthorized access or revision, to ensure that the information is not compromised through corruption or
falsification. (See IQG, Sections 5.land 6.1)
3 EPA Final Pre-Dissemination Review Guidelines. September 2006.
PDR Version 1.1 July 2007
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EPA Region III Quality Management Plan October 2008
6. Determine whether the product is influential. "Influential," when used in the phrase "influential scientific, financial, or
statistical information," means that the Agency can reasonably determine that dissemination of the information will have
or does have a clear and substantial impact (i.e., potential change or effect) on important public policies or private sector
decisions. If the product is influential then a higher degree of transparency for data and methods will be required. Consult
IQG Section 6.3 on transparency requirements.
Approval of information prior to dissemination
7. Obtain approval for the information to be disseminated from the appropriate program director. Approval can include other
types of reviews such as legal reviews, peer reviews, programmatic reviews, scientific and technical review clearance
processes, stakeholder reviews, and product review in accordance with the Office of Public Affairs guidelines.
Records management
8. Pre-dissemination review records (such as the checklist) should be retained with other product documents. Records should
be retained using the appropriate records schedules.
PDR Version 1.1 July 2007
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EPA Region III Quality Management Plan
October 2008
Region III Pre-Dissemination Review Checklist
Product Title
Document Number
or Month / Year of
Release
Product Owner
Work Product Owner
Name
Originating Division or
Office and Branch
Signature and date
IQG-related questions on the work product
Is the product objective?
Is the product useful?
Is the product integrity
assured?
Is the product influential?
Yes
No
Comments / description of actions taken to
fulfill requirements.
Other Quality Reviews
List additional reviews
Review type
Comments
Approving Official
Name
Title
Program or
Office
Signature and date
PDR Version 1.1 July 2007
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EPA Region III Quality Management Plan October 2008
Appendix F
Region III QSA Checklist
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EPA Region III Quality Management Plan
October 2008
EPA REGION III
QUALITY SYSTEM AUDIT CHECKLIST
Person
Interviewed:
Job Title:
Interviewer(s):
Date:
Yrs Experience
(Current Position):
COMMENTS
Duties and Responsibilities
1 . What decisions are supported by the data being
generated by your Section?
2. What are your roles and responsibilities relative
to the collection and/or use of that data?
3. Does your program use data generated by a
third party (i.e., contractors, IAG, grant)? How is
this data being used? (If yes, go to #4. If no, go
to #5)
4. Are you involved in the award of contracts,
extramural agreements and lAGs, which involve
environmental data? If yes, describe your duties
relative to the award of contracts, extramural
agreements and lAGs, which involve
environmental data. How long have you been
doing this?
5. What technical support do you routinely use or
give to assist in making project and/or program
decisions?
QMP
1 . What role did/do you play in the development,
review and/or revision of the Office/Division
QMP?
2. How do managers ensure that QA roles and
responsibilities designated in this document are
performed?
3. To your knowledge are Standard Operating
Procedures being used for any activities in your
jurisdiction?
4. If yes, how do you ensure that the most recent
version of the SOP is being used?
5. If yes, who is responsible for maintaining these
documents?
Quality System Assessments
1 . Please describe the quality system assessments
and/or audits that you or a member of your
section has been subjected to in the last two
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October 2008
EPA REGION III
QUALITY SYSTEM AUDIT CHECKLIST
years?
2. Who performed these assessments and/or
audits?
3. Who is responsible for ensuring that the quality
system being implemented by others (i.e., PRPs,
states, contractors, other government Agencies
(lAG's)) who provide data for your projects is
adequate? If this is your responsibility, how do
you do this?
4. Who is responsible for ensuring that corrective
actions from quality system audit/assessment
reports are implemented? How are these
actions being documented?
Extramural Agreements
Contracts
1. How do you ensure that requests for proposals,
work assignments, task orders or acquisitions
that involve environmental data collection and/ or
use contain acceptable QA requirements? If you
are not responsible for this task, who is?
2. What are the typical QA requirements that are
included in RFPs, work assignments, task
orders, etc?
3. For contracts, do you use a QA Review Form? If
yes, when is it used? If no, how are QA
requirements being communicated to the
Contracting Officer?
4. When applicable, who is responsible for ensuring
that QMPs are reviewed and approved before
the collection and/or use of environmental data?
How are the results of QMP reviews and
approvals distributed to you? (Reviewers - Does
the file have evidence that there was an
approved QMP for this grant? If no, ask where
this information can be found.)
5. When applicable, who is responsible for the
review of QAPPs for projects that involve
environmental data collection or use? If you are
not responsible, how are the results of QAPP
reviews being given to you? (Reviewers - Does
the file have evidence that there was a QAPP
review before approval? If no, ask where this
information can be found.)
6. Who is responsible for the approval of contractor
QAPPs? How is this information transmitted to
the contractor? (Reviewers - Does the file have
evidence that there was an approved QAAP
before data collection and/or use? If no, ask
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EPA REGION III
QUALITY SYSTEM AUDIT CHECKLIST
8.
where this information can be found.)
Who is responsible for ensuring that contractors
implement the QA/QC activities found in the
approved QAPP? How is this being done?
(Reviewers - Does the file have evidence of
audits, assessments, etc.? If no, ask where this
information can be found.)
How is the data being evaluated to ensure that
the contractor met the requirements specified in
the QAPP? Who is responsible for this task?
(Reviewers - Does the file have evidence of data
validation reports, data assessments, etc. ? If no,
ask where this information can be found.)
G rants/IAG
9. How do you ensure that grants and lAGs that
involve the collection and/or use of
environmental data contain acceptable QA
requirements? If you are not responsible for this
task, who is?
10. What are the typical QA requirements found in
extramural agreements and lAGs?
11. Would you provide examples of how this
requirement is being communicated to grantees,
IAG participants and OPM? (Reviewers - Does
the grant contain information about QA
requirements? If no, ask where this information
can be found.)
12. When applicable, who is responsible for ensuring
that QMPs are reviewed and approved before
the collection and/or use of environmental data?
How are the results of QMP reviews and
approvals distributed to you? (Reviewers - Does
the grant file have evidence that there was an
approved QMP for this grant? If no, ask where
this information can be found.)
13. When applicable, who is responsible for the
review of QAPPs for projects that involve
environmental data collection or use? If you are
not responsible, how are the results of QAPP
reviews being distributed to you? (Reviewers -
Does the grant file have evidence that there was
a QAPP review? If no, ask where this
information can be found.)
14. Who is responsible for the approval of QAPPs for
grantees? How is this information transmitted to
the grantee or government agency? (Reviewers -
Does the grant file have evidence there was an
approved QAPP before data collection or use? If
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EPA REGION III
QUALITY SYSTEM AUDIT CHECKLIST
no, ask where this information can be found.)
15. Who is responsible for ensuring that grantees or
government agencies implement the QA/QC
activities found in the approved QAPP? Who is
responsible for this task? (Reviewers - Does the
grant file have evidence of audits, assessments,
etc. ? If no, ask where this information can be
found.)
16. How is the data evaluated to ensure it met the
requirements specified in the QAPP? Who is
responsible for this task? (Reviewers - Does the
grant file include data validation reports, data
assessments, etc? If no, ask where this
information can be found.)
Training
1. What QA-related courses have you taken? Did
you find the information presented in the
course(s) helpful?
2. What QA-related courses would you like to take?
Why?
3. How is training being documented? Who
maintains the records?
Systematic Planning (Project Officers,
Toxicologist, Hydrologists, Geologists)
1. Are you involved in project planning (i.e., level of
QA/QC required, sampling and analytical
protocols, establishing project goals, etc.)? If no,
go to next section. If yes, go to question #2.
2. What process is being used to define intended
data uses, level of quality required, sampling and
analytical protocols, project goals and objectives,
etc. before the initiation of a project which
involves environmental data collection or use?
3. Who is responsible for ensuring that a systematic
planning process is being performed?
4. Who is currently involved in the planning
process?
5. How is the process documented?
6. Is this process being used for all of your
projects? If not, why not?
7. Would you provide a copy of documentation (i.e.,
notes, scoping meeting minutes, etc.) which
shows systematic planning process for two sites
that have had activity in the last 2 years?
Quality Assurance Project Plans (Project
Officers, Hydrologist, Toxicologists, Geologists)
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EPA Region III Quality Management Plan
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EPA REGION III
QUALITY SYSTEM AUDIT CHECKLIST
1. Are you involved in the review and/or approval of
QAPPs? If yes, go to question #2. If no, go to
next section. (For toxicologists, hydrologists,
geologists)
2. Who is responsible for the review and approval
of QAPPs before the initiation of environmental
data activities?
3. Where are approved QAPPs being kept?
(Project Officer)
4. Would you provide a copy of an approval letter
or a signature page for a site-specific Sampling
and Analysis Plan and/or QAPP for two sites that
have had activity in the past 2 years? (Project
Officer)
5. Who is responsible for ensuring that contractors,
grantees and/or EPA personnel implement the
QA/QC activities found in the approved QAPP?
How is this being done?
6. Describe the technical assessments/audits (i.e.,
readiness reviews, surveillance, technical
system audits, P/Ts, etc.) that are being
conducted at your sites? (Project Officer)
7. When are these assessments being performed?
What is your involvement in this process?
8. Would you be able to provide copies of ISA
reports performed at two of your sites in the past
0-3 years? Also, briefly describe how the results
of these assessments were used?
Data Verification and Validation
1. Do you use secondary data (i.e., databases,
literature, models) to make environmental
decisions? How do you evaluate this data before
use to determine that it meets your project
objectives?
2. Describe the procedures being used to ensure
that the data is adequate for the intended use.
Who is responsible for this task?
3. Would you provide examples of data verification
and/or validation reports for two sites that have
had activity in the past 0-2 years?
4. Is this process being followed by all parties (i.e.,
States, contractors, PRPs, etc.) who submit data
for your use? If not, why not?
5. How are the results of these data validation
reports being used?
6. How are qualifiers being interpreted in final
reports?
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EPA Region III Quality Management Plan
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EPA REGION III
QUALITY SYSTEM AUDIT CHECKLIST
7. What procedures are being used to evaluate
data to ensure it meets project and/or program
objectives?
8. Who is responsible for conducting this task?
9. Would you provide two examples of data quality
assessment reports for two sites that have had
activity in the past 0-2 years?
10. How are the results of these DQA reports being
used?
Quality Improvement
1. What recommendations would you make to
improve your Division's quality system?
2. Do you believe you are getting sufficient
management support to perform your job
effectively?
3. Do you believe you have sufficient resources to
perform your job effectively?
Other Comments
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EPA REGION III
QUALITY SYSTEM AUDIT CHECKLIST
INTERVIEWER EVALUATION
Requirement (EPA ORDER 5360.1 A2)
1 . Develop a QMP and implement this plan following Agency approval.
2. Perform assessments of the effectiveness of the quality system at
least annually and implement corrective actions based on
assessment results in a timely manner.
3. Submit information for Region 3 QA Status Report.
4. Implement Agency-wide Quality System requirements in all
applicable EPA-funded extramural agreements.
5. Provide appropriate QA/QC training for all levels of management and
staff.
6. Use a systematic planning approach to develop acceptance or
performance criteria for all work covered by the Division/Program
Quality System.
7. Have approved QA Project Plans, or equivalent documents for all
applicable projects and tasks involving environmental data.
8. Assess existing data, when used to support Agency decisions or
other secondary purposes, to verify that they are of sufficient quantity
and adequate quality for their intended use.
YES
NO
N/A
Requirement #
For each item that has NO response, briefly describe the documented and/or verbal evidence
that this has not occurred. Describe impact on quality of data being generated by or for this
Division/Program. Include recommendations to alleviate the problem.
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EPA Region III Quality Management Plan October 2008
Appendix G
References
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EPA Region III Quality Management Plan October 2008
REFERENCES
Quality System Documents (Web site: http://www. epa. soy/quality/)
Specifications and Guidelines for Quality Systems for Environmental Data Collection and
Environmental Technology Programs (ANSI/ASQC E4-1994); American Society for
Quality Control (ASQC), 1994.
Specifications and Guidelines for Quality Systems for Environmental Data Collection and
Environmental Technology Programs (ANSI/ASQC E4-2004); American Society for
Quality (ASQ), 2004.
Policy and Program Specifications for the Mandatory Agency-wide Quality System; EPA Order
5360.1 A2 (CIO Policy 2105.0); U.S. Environmental Protection Agency; Washington,
DC, 2000.
EPA Quality Manual for Environmental Programs; EPA Order 5360 Al (CIO Procedure 2105-P-
01); U.S. Environmental Protection Agency, Washington, DC, 2000.
EPA Requirements for Quality Management Plans (R-2); EPA/240/B-01/002; U.S.
Environmental Protection Agency, Washington, DC, 2001.
Guidance on Assessing Quality Systems (G-3); EPA/240/R-03/002; U.S. Environmental
Protection Agency, Washington, DC, 2003.
EPA Requirements for QA Project Plans (R-5); EPA/240/B-01/003; U.S. Environmental
Protection Agency, Washington, DC, 2001.
Guidance on Systematic Planning using the Data Quality Objectives Process (G-4); EPA/240/B-
06/001; U.S. Environmental Protection Agency, Washington, DC, 2006.
Guidance on Quality Assurance Project Plans (G-5); EPA/600/R-02/009; U.S. Environmental
Protection Agency, Washington, DC, 2002.
Guidance for Geospatial Data Quality Assurance Project Plans (G-5G); EPA/240/R-03/003;
U.S. Environmental Protection Agency, Washington, DC, 2003.
Guidance for Preparing Standard Operating Procedures (G-6); EPA/600/B-07/001; U.S.
Environmental Protection Agency, Washington, DC, 2007.
Guidance on Technical Audits and Related Assessments for Environmental Data Operations (G-
7); EPA/600/R-99/080; U.S. Environmental Protection Agency, Washington, DC, 2000.
Guidance on Environmental Data Verification and Data Validation f'G-S);EPA/240/R-02/004;
U.S. Environmental Protection Agency, Washington, DC, 2002.
Data Quality Assessment: A Reviewer's Guide (G-9R); EPA/240/B-06/002; U.S. Environmental
Protection Agency, Washington, DC, 2006.
Data Quality Assessment: Statistical Methods for Practitioners (G-9S); EPA/240/B-06/003; U.S.
Environmental Protection Agency, Washington, DC, 2006.
Guidance for Developing a Training Program for Quality Systems (G-10), EPA/240/B-00/004;
U.S. Environmental Protection Agency, Washington, DC, 2000.
Guidance for Quality Assurance for Environmental Technology Design, Construction and
Operation (G-ll); EPA/240/B-05/001; U.S. Environmental Protection Agency,
Washington, DC, 2005.
Peer Review Handbook, 3rdEdition, EPA/100/B-06/002, U.S. Environmental Protection Agency,
Washington, DC, 2001.
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EPA Region III Quality Management Plan October 2008
Information Management
Chemical Abstract Service Registry Number Data Standard, EPA Order 2180.1, U.S.
Environmental Protection Agency, Office of Environmental Information, Office of
Technology Operations and Planning, Information Technology Policy and Planning
Division; Washington, DC, 1987. (Web Site:
http://www.epa.gov/irmpoli8/casstandard/index.html)
Chesapeake Information Management System Major Project 14 Point Development Protocol;
U.S. Environmental Protection Agency, Region III, Chesapeake Bay Program Office,
Annapolis, MD, 1999.
Data Standards Policy; EPA CIO 2133.0; U.S. Environmental Protection Agency; Office of
Environmental Information; Washington, DC; 2007.
Federal Information Processing Standards; National Institute of Standards and Technology;
Gaithersburg, MD, 2008. (Web site: http://www.itl.nist.gov/fipspubs/)
Information Resources Management Policy Manual, CIO Policy 2100.0, U.S. Environmental
Protection Agency, Office of Environmental Information, Washington, DC, 1987.
Site Location Identification Policy and Responsibilities; Region III Order 5361.5; U.S.
Environmental Protection Agency, Region III; Philadelphia, PA, 1988.
System Life Cycle Management Policy; CIO Policy 2121.0; U.S. Environmental Protection
Agency, Office of Environmental Information, Washington, DC, 2006.
Program Documents
Chesapeake Bay Program, Grant and Cooperative Agreement Guidance; U.S. Environmental
Protection Agency, Chesapeake Bay Program Office; Annapolis, MD, 2008.
EPCRA Section 313 Data Quality Inspection Manual; 68-C8-0066, 68-DO-0020; U.S.
Environmental Protection Agency, Office of Water; Washington, DC, 1992.
Generic Quality Assurance Project Plan Guidance for Programs Using Community Level
Biological Assessment in Wadable Streams and Rivers; EPA 841-B-95-004; U.S.
Environmental Protection Agency, Office of Water; Washington, DC, 1995.
Graves, J., Metadata Tools Manual for EPA Region III (Draft); U.S. Environmental Protection
Agency, Office of Environmental Data; Philadelphia, PA, 2001.
Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility and Integrity of
Information Disseminated by EPA; EPA/260R/02-008; U.S. Environmental Protection
Agency, Office of Environmental Information, Washington, DC, 2002. (Web site:
http://www.epa.gov/quality/informationguidelines/).
Manual for the Certification of Laboratories Analyzing Drinking Water; EPA 815-R-05-004;
U.S. Environmental Protection Agency, Office of Water; Washington, DC, 2005.
NPDESCompliance Inspection Manual, EPA 305-X-03-004; U.S. Environmental Protection
Agency, Office of Enforcement and Compliance Assistance; Washington, DC, 2004.
NPDES Self-Monitoring Data and Data Inspections DAIs; EPA-903-R-94-043; U.S.
Environmental Protection Agency, Office of Wastewater Management; Washington,
DC, 1994.
On-Site Inspection of SuperfundPRP Monitoring Procedures; U.S. Environmental Protection
Agency, Region III, Philadelphia, PA, 2000.
RCRA Inspection Manual; EC-G-1999-001; U.S. Environmental Protection Agency, Office of
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Solid Waste and Emergency Response; Washington, DC, 1998.
Uniform Federal Policy for Implementing Environmental Quality Systems, Final, Version 2;
Intergovernmental Data Quality Task Force; 2005.
Uniform Federal Policy for Quality Assurance Project Plans, UFP-QAPP Manual, Final, Version
7; Intergovernmental Data Quality Task Force; 2005.
Volunteer Monitor's Guide to Quality Assurance Project Plans; U.S. Environmental Protection
Agency, Office of Wetlands, Oceans and Watersheds; Washington, DC, 1996.
Quality Management Plans/Quality Manuals
Air Protection Division Quality Management Plan, U.S. Environmental Protection Agency; Air
Protection Division; Philadelphia, PA, October 2006.
Chesapeake Bay Program Office Quality Management Plan; U.S. Environmental Protection
Agency, Chesapeake Bay Program Office; Annapolis, MD, June 2005.
Environmental Assessment and Innovation Division Quality Management Plan; U.S.
Environmental Protection Agency; Environmental Assessment and Innovation
Division; Philadelphia, PA, June 2006.
Hazardous Site Cleanup Division Quality Management Plan; U.S. Environmental
Protection Agency; Hazardous Site Cleanup Division; Philadelphia, PA, July 2005.
Office of Analytical Services and Quality Assurance (OASQA) Laboratory Quality Manual,
Laboratory Branch, Freshwater Biology Team, Associate Director's Immediate Office,
Version 6 ; U.S. Environmental Protection Agency; Environmental Services Division,
Office of Analytical Services and Quality Assurance; Fort Meade, MD, August 6, 2007.
Quality Management Plan for Ocean Dumping Program; U.S. Environmental Protection
Agency; Environmental Assistance and Innovation Division; Philadelphia, PA,
2001.
Waste and Chemicals Management Division Quality Management Plan; U.S. Environmental
Protection Agency; Waste and Chemicals Management Division; Philadelphia, PA,
March 2005.
Water Protection Division Quality Management Plan; U.S. Environmental Protection Agency;
Water Protection Division; Philadelphia, PA, July 2007.
Records Management
A User Guide for Getting Started in ECMS E-mail Records, ECMS, U.S. Environmental
Protection Agency, Washington, DC, 2007. (Web site:
http://intranet.epa.gov/ecms/Attachments-for-the-Web/ECMS E-mail User Guide.pdf)
Disposition of Federal Records: A Records Management Handbook, NARA Personal Papers of
Executive Branch Officials: A Management Guide (Management Guide Series), 2000.
(Web site: http://www.archives.gov/records-mgmt/pdf/dfr-2000.pdf)
Federal Records Management Laws and Regulations, NARA. (Web site:
http://www.archives.gov/records-mgmt/laws/index.html)
Managing Cartographic and Architectural Records (Instructional Guide Series), National Archives
and Records Administration (NARA). (Web site:
http://www.archives.gov/research/formats/cartographic.html)
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EPA Region III Quality Management Plan October 2008
Managing Electronic Records (Instructional Guide Series), NARA. (Web site:
http://toolkit.archives.gov/pls/htmldb/f?p=102:1:10272796255933812381)
OMB Circular A-130, Management of Federal Information Resources; 36 CFR Chapter XII,
Sub chapter B. (Web site: http://www.whitehouse.gov/omb/circulars/al30/al30.html)
Records Disposition Schedules, U.S. Environmental Protection Agency. (Web site:
http ://intranet. epa. gov/records/schedule/index.htm)
Records Management Manual; U. S. Environmental Protection Agency; National Records
Management Program, Washington, DC. (Web site:
http://www.epa.gov/records/policy/manual/index.htm)
Records Management Policy; CIO Directive 2155.0; U.S. Environmental Protection Agency,
Office of Environmental Information, Office of Technology Operations and Planning,
Information Technology Policy and Planning Division; Washington, DC, 2006. (Web
Site: http://www.epa.gov/records/policy/index.htm)
Sampling and Analysis
CLP National Functional Guidelines (Series); U.S. Environmental Protection Agency,
Washington, DC. (Web site:
http://www.epa.gov/superfund/programs/clp/guidance.htm)
General Requirements for the Competence of Testing and Calibration Laboratories; ISO/IEC
17025; International Organization for Standardization and the International Electro-
technical Commission; 2005.
National Environmental Laboratory Accreditation Conference (NELAC) Standards;
EPA/600/R-04/003; The NELAC Institute, 2003.
National Environmental Methods Index; National Water Quality Monitoring Council;
Washington, DC. (Web Site http://www.nemi.gov)
Quality Management and Quality System Elements for Laboratories - Guidelines; ANSI/ASQC
Q2-1991; American National Standards Institute, Washington, DC 1991.
Recommended Guidelines for Sampling and Analyses in the Chesapeake Bay Monitoring
Program., EPA 903-R-96-006; U.S. Environmental Protection Agency, Region III,
Chesapeake Bay Program Office; Annapolis, MD, 1996.
Region III Office of Analytical Services and Quality Assurance (OASQA) Sample Submission
Guidelines, Revision 11.0; U.S. Environmental Protection Agency, Region III,
Environmental Services Division, Office of Analytical Services and Quality Assurance;
Fort Meade, MD, 2002.
Contracts Management
Acquisition Handbook; U.S. Environmental Protection Agency, Washington, DC, 2007. (Web
site: http://intranet.epa.gov/oamintra/policy/ah(new).pdf)
EPA Contracts Management Manual; U.S. Environmental Protection Agency, Washington, DC
2008. (Web site: http://epawww.epa.gov/oamintra/policy/cmm.pdf)
Guidance for Use of Higher-Level Contract Quality Requirements in Acquisitions; Procurement
Policy Notice 01-02; U.S. Environmental Protection Agency, Washington, DC, 2001.
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