US Environmental Protection Agency
Region III - Middle Atlantic States
1650 Arch Street
Philadelphia, Pennsylvania 19103-2029
QUALITY
MANAGEMENT
PLAN
Revision 2
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Region III QUALITY MANAGEMENT PLAN APPROVALS
/s/ Monica D. Jones
Monica D. Jones
Region III Quality Assurance Manager
/s/ Donald S. Welsh
Donald S. Welsh
Regional Administrator
Nancy Wentworth
Director, Quality Staff, Office of Environmental Information
5/30/03
Date
6/4/03
Date
Date
Kim Nelson
Assistant Administrator, Office of Environmental Information
Date
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FROM EPA, OSWE3, OSff, CIRM, RMB (FED 07. 18'03 06:53, ST. Go:52, NO. 356147449? P 2
? A \ UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
* WASHINGTON. D:C. 20460
JUL -7 2D3
OmCEOP
ENVWONMEMni INFORMATION
MEMORANDUM
SUBJECT: Approval of the Region 3 Quality Management Plan
FROM: Reggie Cheatham
Acting Director. Quality Staff (2811R)
TO: Donald S. Welsh
Regional Administrator, Region 3
I am pleased to approve the Quality Management Plan (QMP) for Region 3. Approval is
valid for a period not to exceed five years from the date of this memorandum- Please remember
that organizationaTand/or mission changes may make it necessary for you to revise and resubmit
thcQMP before the five-year approval period expires, per Section 3.2.4 of the EPA Manual 5360
A1, EPA Quality Manual for Environmental Programs (May 2000).
The Region3 QMP was reviewed in accordance with the specifications contained in
Chapter 3 of EPA Manual.5360 Al. Our review determined that Region 3 has made a number of
improvements to its QMP that will strengthen the quality system.
I look forward to the successful implementation of your QMP. Shoufd you have farther
questions, please call me at (202) 564-6830.
Attachment
cc: Monica Jones, Regional QA Manager
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TABLE OF CONTENTS
1.0 MANAGEMENT AND ORGANIZATION 1
1.1. REGIONAL QUALITY ASSURANCE POLICY 1
1.1.1 Background 1
1.1.2 Region HI QA Policy 1
1.1.3 Resources for the QA System 2
1.2 SCOPE OF THE QUALITY MANAGEMENT PLAN 3
1.2.1 Examples of Programs Covered by Region III Quality System 3
1.2.1.1 Air Protection Division 3
1.2.1.2 Chesapeake Bay Program Office 3
1.2.1.3 Environmental Assessment and Innovation Division 3
1.2.1.4 Hazardous Site Cleanup Division 4
1.2.1.5 Office of Enforcement, Compliance and Environmental Justice .. 4
1.2.1.6 Waste and Chemicals Management Division 4
1.2.1.7 Water Protection Division 5
1.2.2 Delegated Programs 5
1.3 REGION III ORGANIZATIONAL STRUCTURE 6
1.4 ROLES AND RESPONSIBILITIES 7
1.4.1 Regional Administrator and Senior Managers 7
1.4.2 Regional Quality Council (RQC) 8
1.4.3 Senior Management Representative to the Regional Quality Council.... 8
1.4.4 Regional Quality Assurance Manager (RQAM) 8
1.4.5 Regional Quality Assurance Officer (RQAO) 9
1.4.6 Quality Assurance Coordinator (QAC) 9
1.4.7 Quality Assurance Team 10
1.4.8 Program Managers 10
1.4.9 Project Officers and Work Assignment Managers 10
1.4.10 ASQAB Lab Quality Assurance Officer (QAO) 11
1.4.11 ASQAB Lab Technical Director (TD) 12
1.4.12 Analytical Team 12
1.4.13 Client Services Team 12
1.4.14 Freshwater Biology Unit .13
1.4.15 Office of Enforcement, Compliance and Environmental Justice (OECEJ)
Field Personnel 13
1.5 COMMUNICATIONS 13
1.6 DISPUTE RESOLUTION 14
2.0 QUALITY SYSTEM COMPONENTS 15
2.1 PRINCIPAL COMPONENTS OF THE SYSTEM 15
2.2 QUALITY MANAGEMENT PLANS (QMP) 15
2.2.1 Region III Quality Management Plans 15
2.2.2 Division/Program Quality Management Plans 16
2.2.3 Quality Management Plans for Extramural Projects 16
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Page
2.3 LABORATORY QUALITY MANUAL 17
2.3.1 Analytical Services and Quality Assurance Branch 17
2.3.2 Freshwater Biology Laboratory 17
2.4 QA ANNUAL REPORT AND WORK PLAN 17
2.5 QUALITY SYSTEM STATUS REPORT 18
2.6 QUALITY SYSTEM AUDITS 18
2.7 TRAINING PLANS 18
2.8 DATA QUALITY OBJECTIVES PROCESS 19
2.9 QUALITY ASSURANCE PROJECT PLANS (QAPPs) 19
2.10 STANDARD OPERATING PROCEDURES (SOPs) 20
2.11 TECHNICAL SYSTEMS AUDITS (TSA) 20
2.12 PROFICIENCY TESTING SAMPLES 20
2.13 DATA QUALITY ASSESSMENTS 21
3.0 QUALIFICATION AND TRAINING 22
3.1 Region HI'S QA TRAINING PROGRAM 22
3.1.1 Courses 22
3.1.2 Logistics 23
3.1.3 Documentation of Training 23
3.2 TRAINING REQUIREMENTS 23
3.2.1 Regional Administrator and Senior Managers 24
3.2.2 Program Managers 24
3.2.3 Project Officers and Work Assignment Managers 24
3.2.4 Regional Quality Assurance Manager (RQAM) 24
3.2.5 Regional Quality Assurance Officer (RQAO) 25
3.2.6. Quality Assurance Coordinators 25
3.2.7 Quality Assurance Team 25
3.2.8 Analytical Team and Freshwater Biology Staff 25
3.2.9 Client Services Team 26
3.3 RECERTIFICATION 26
4.0 PROCUREMENT OF ITEMS & SERVICES 27
4.1 ACQUISITIONS BY US GOVERNMENT CONTRACTING OFFICERS 27
4.2 SMALL PURCHASES 28
4.3 GRANTS AND COOPERATIVE AGREEMENTS 29
4.4 INTERAGENCY AGREEMENTS (IAGS) 30
5.0 DOCUMENTATION AND RECORDS MANAGEMENT 31
6.0 COMPUTER HARDWARE AND SOFTWARE 33
6.1 COMPUTER HARDWARE/SOFTWARE REQUIREMENTS 33
6.2 SYSTEM DEVELOPMENT 33
6.3 DATA STANDARDS .' 34
6.4 INFORMATION SECURITY 35
6.5 GEOGRAPHIC INFORMATION SYSTEMS (GIS) 36
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6.5.1 Project Management ..
6.5.2 Primary Data
6.5.3 Secondary Use Products
6.5.4 Summary
7.0 PLANNING 39
7.1 REGION-WIDE PLANNING 39
7.1.1 Internal Strategic Planning 39
7.1.2 External Data Coordination 39
7.1.3 Annual QA Plan 39
7.2 PROGRAM-SPECIFIC PLANNING 39
7.3 PROJECT LEVEL PLANNING 40
7.3.1 Quality Assurance Project Plan Preparation, Review, and Approval ... 40
7.3.2 Generic Quality Assurance Project Plans 41
7.3.3 Secondary Data 42
8.0 IMPLEMENTATION OF WORK PROCESSES 44
8.1 PROGRAM IMPLEMENTATION 44
8.2 PROJECT 45
8.2.1 Quality Assurance Project Plans 45
8.2.2 Standard Operating Procedures 46
8.2.3 EPA Region III Users' Guide for Acquiring Analytical Services 46
8.2.4 Region III OASQA Sample Submission Guidelines 46
8.2.5 Inspections 46
9.0 ASSESSMENT AND RESPONSE 48
9.1 QUALITY SYSTEM AUDITS (QSA) 48
9.1.1 Internal Quality System Assessments 48
9.1.2 External Quality System Assessments 49
9.2 TECHNICAL SYSTEMS AUDITS (TSA) 50
9.3 LABORATORY ASSESSMENTS 51
9.3.1 National Pollution Discharge Elimination System (NPDES) 50
9.3.2 Safe Drinking Water Act (SDWA) 51
9.3.3 Superfund Program: Laboratories used by Principally Responsible
Parties (PRP) 51
9.3.4 Contract Laboratory Program (CLP)-Routine Analytical
Services (RAS) 52
9.3.5 Delivery of Analytical Services (DAS) 52
9.3.6 National Environmental Laboratory Accreditation Conference(NELAC) 53
9.4 DATA QUALITY ASSESSMENTS 53
10.0 QUALITY IMPROVEMENT 54
10.1 APPROACH TO IMPROVEMENT 54
10.2 IMPROVEMENT LEADERS 54
10.2.1 Program Level 54
10.2.2 Project Level 55
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APPENDIX A: List of Standard Operating Procedures A-l
APPENDIX B: References B-l
APPENDIX C: Glossary of Terms C-l
LIST OF FIGURES
Organizational Chart: Environmental Protection Agency, Region III Figure 1
Region III Organization Chart: QA Functions Figure 2
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LIST OF ABBREVIATIONS
AA
Accrediting Authorities
ADP
Automated Data Processing
APD
Air Protection Division
ASQAB
Analytical Services and Quality Assurance Branch
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
FIRMA
Federal Information Resources Management Regulations
GIS
Geographic Information Systems
HSCD
Hazardous Site Cleanup Division
IAG
Interagency Agreement
ICMS
Integrated Contract Management System
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
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
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 Project Plan
QC
Quality Control
QMP
Quality Management Plan
QSA
Quality System Assessment
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LIST OF ACRONYMS
RCRA
Resource Conservation and Recovery Act
RQAM
Regional Quality Assurance Manager
RQAO
Regional Quality Assurance Officer
RQC
Regional Quality Council
SARA
Superfund Amendments and Reauthorization Act
SAP
Sampling and Analysis Plan
SDWA
Safe Drinking Water Act
SOP
Standard Operating Procedure
TD
Technical Director
TMDL
Total Maximum Daily Load
TSA
Technical Systems Audit
TSCA
Toxic Substances Control Act
WAM
Work Assignment Manager
WCMD
Waste and Chemicals Management Division
WPD
Water Protection Division
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CHAPTER 1: MANAGEMENT AND ORGANIZATION
1:1. REGIONAL QUALITY ASSURANCE POLICY
1.1.1 Background
Region ID has maintained the fundamental components of a quality system since the
establishment of the Regional Office in the early 1970's. Following the issuance of EPA Order
5360.1 CHG 1 in 1998, the Region began to systematically implement its quality management
system. The Region III Quality Management Plan (QMP) describes the policies, procedures and
management systems within the organization that govern the quality control activities. Quality
assurance (QA) requirements are integrated into each of the Region's media programs.
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
assessment phase.
1.1.2 Region III QA Policy
It is Region Ill's QA policy that all environmental data operations result in the collection
of environmental data of known and documented quality, suitable for its intended use. This
policy applies to all data collected under environmental operations and environmental technology
activities performed directly by the Region; Federal, State, Tribal and local partners under
interagency agreements and financial assistance agreements; contractors funded by EPA;
regulated entities and potentially responsible parties.
Specifically, it is the policy of Region III that:
o Each Regional program or activity that is responsible for the characterization of
environmental or ecological systems and the health of human populations; or the direct
measurement of environmental conditions or releases; or the use of environmental data collected
from other sources will be part of an effective quality system. This quality system shall be
documented in a Program, Division or Office QMP.
o The objectives for generating any new environmental data shall be determined prior to
data collection and control methods can be applied to ensure a level of data quality
commensurate with the intended use(s) for the data. These objectives will be documented in the
project's Quality Assurance Project Plan (QAPP).
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Rffl 5360.1 A CHG 2
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o Prior to the use of environmental data collected from other sources, such as literature,
industry surveys, databases or computerized models, the data shall be evaluated to ensure a level
of data quality that is commensurate with the intended use(s) of the data.
o Each program or activity that generates environmental data shall develop and
implement a QAPP and/or Standard Operating Procedures (SOPs) which specifies the detailed
procedures required to assure production of data of known quality and sufficient quantity to
support environmental decisions. These QAPP's shall be prepared by the originating program,
and reviewed and approved by an authorized QA representative prior to the start of any data
collection effort.
o All Regional programs that receive externally generated environmental data through
contracts, grants or interagency agreements shall ensure that acceptable QA requirements are
included in the appropriate extramural agreement documents. These external parties must submit
a QMP and a QAPP or a combined QMP/QAPP to EPA for review and approval.
o QA practices and quality control (QC) procedures will be implemented in the most cost
effective manner possible without compromising data quality objectives.
o There shall be an annual assessment of the Region's Quality System to ensure that it is
meeting the needs and expectations of our external and internal customers and QA requirements
and guidelines set forth in the EPA Quality Manual (5360.1 Al) and EPA Order (5360.1 A2).
The annual assessment of the Region's Quality System will be conducted by the Regional
Quality Assurance Manager (RQAM), in conjunction with the Regional Quality Council (RQC).
o The Region will ensure that EPA disseminated information products will be 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.
1.1.3 Resources for the QA System
The level of QA resources needed for an environmental program or project is determined
by the relevant Regional program. Each Division or Program Director shall ensure that there are
adequate resources to successfully implement their environmental programs. Since there exists
no assigned national program element for QA, most resources needed for QA are taken from a
variety of program elements which utilize QA functions and services.
Annually, the RQC will assess the adequacy of QA resources and the level of expertise
necessary to support 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 RQC will
provide Senior Managers with the results of their assessment of the Region's QA resources and
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recommendations for ways to resolve any outstanding issues. Senior Managers are responsible
for making final decisions about the allocation of QA resources.
1.2 SCOPE OF THE QUALITY MANAGEMENT PLAN
This QMP establishes the foundation for implementing an effective quality system within
EPA Region in. The QMP applies to all Region III programs, activities, grants, contracts and
interagency agreements that collect or evaluate environmental data which is used to make
decisions or support actions related to our defined mission and responsibilities. Environmental
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 data also includes information
produced from models, and compiled from other sources such as data bases or the literature.
Therefore, programs, activities, grants, contracts and interagency agreements which generate
and/or compile environmental data are required to comply with the requirements of this QMP.
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. Listed below are examples of the types of
environmental programs, grants and activities within each Division or Program Office which are
covered by the Region III Quality System.
1.2.1 Examples of Programs Covered by Region III Quality System
1.2.1.1 Air Protection Division
Clean Air Act
Ambient Air Quality Data (monitoring by states via 105 grant
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)
Environmental data collected as a result of a contract being
overseen by an APD Project Manager/Project Officer
CAA Compliance Inspections
1.2.1.2 Chesapeake Bay Program Office
Mainstem and Tributary Monitoring Program
Ambient Toxicity Monitoring Program
Baywide SAV Aerial Survey Program
1.2.1.3 Environmental Assessment and Innovation Division
Laboratory Analyses - performed at Ft Meade and Wheeling labs
Watershed Protection Program
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Water Quality Management (106) Grants Program
Ocean Dumping Program
Community-Based Special Studies (e.g., Newton-Chester, Monroe
County)
Fish Tissue Surveys
Dredging
Coastal Waters Sampling
. Wetland Grants
Inspection (NPDES laboratory assessments of State and regulated
laboratories, Superfiind PRP laboratories, State drinking water
laboratories)
1.2.1.4 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.
1.2.1.5 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
1.2.1.6 Waste and Chemicals Management 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
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RIH 5360.1 A CHG 2
June 4, 2003
RCRA Subtitle I grants
Delisting
TSCA
TSCA 404(g) lead grants
PCB enforcement
Other TSCA lead grants
1.2.1.7 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
Watershed Protection Program
Nonpoint Source (Section 319) Grants Program
Clean Lakes Program
State Revolving Fund Program
Water Quality Standards Program
Nutrient Criteria Program
Water Quality Cooperative Agreements (Section 104(b)(3)) Grant
Program
Total Maximum Daily Load (TMDL) Program
Great Lakes Program
Ambient water monitoring (routine monitoring performed mostly
through the states)
National Estuary Program
Beaches
1.2.2 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, West Virginia:
RCRA Subtitle C (hazardous waste)
RCRA Subtitle I (underground storage tanks)
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June 4,2003
Air - Clean Air Act T itle I permits; T itle 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
Pretreatment
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; the states have first responsibility. The Region's
QA responsibilities in relation to these delegated programs is oversight through mid-year
program reviews, end of the year program reviews, and approval of QMPs and QAPPs.
1.3 REGION III ORGANIZATIONAL STRUCTURE
The Region is composed of five Divisions and four Program Offices. The Program
Divisions are the Air Protection Division (APD), Environmental Assessment and Innovation
Division (EAID), Hazardous Site Cleanup Division (HSCD), Waste and Chemicals Management
Division (WCMD) and the Water Protection Division (WPD). The four Offices are the
Chesapeake Bay Program Office (CBPO), Office of Regional Counsel (ORC), Office of
Enforcement, Compliance and Environmental Justice (OECEJ), and the Office of Policy and
Management (OPM). A copy of the Region's organizational chart can be found in Figure 1.
Region III employs a decentralized approach to QA management, whereby each Division
or Office is responsible for deciding how it will implement the general policies and procedures of
this QMP. Division or Program Office QA requirements may be more, but not less stringent than
those presented in this QMP. The Regional Administrator has delegated responsibility for
overseeing the Region's Quality System to the Environmental Assessment and Innovation
Division (EAID). The RQAM is located in the Immediate Office of the EAID Division Director.
The RQAM is independent of direct environmental data generation, model development, or
environmental technology development. On issues relative to the Region's quality system, the
RQAM reports to the Senior Management Representative to the Regional Quality Council. The
Regional QA Officer (RQAO) is located in the EAID Environmental Information and Analysis
Branch. Within EAID's ASQAB, there is a Quality Assurance Team (QAT) which provides
technical support to various Regional programs. For additional information about the roles and
responsibilities of the RQAM, RQAO and QAT, refer to Section 1.4.
Each Division and Program Office which collects and/or evaluates environmental data
assigns a Quality Assurance Coordinator (QAC) to the RQC. The RQC is responsible for
the implementation of the Region's Quality System. The membership of the RQC includes the
RQAM, a Senior Management Representative, the RQAO and the QACs. The structure and
function of the RQC allows each level of the organization to participate in maintaining and
improving the Region's Quality System. If there are QA issues that cannot be resolved by the
RQC, the Senior Management Representative to the RQC, the RQAM and the RQC will raise
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RIII 5360.1 A CHG 2
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these issues to the Regional Administrator and Senior Managers. An organizational chart which
shows the reporting relationships for Region III QA personnel can be found in Figure 2.
Additional information about the roles and responsibilities of the Senior Management
Representative and the RQC can be found in Section 1.4.
1.4 ROLES AND RESPONSIBILITIES
All individuals in the Region who are directly or indirectly involved with environmental
data collection, analyses or use has some responsibility for ensuring data quality. This may
include staff level personnel, supervisors, project officers, program managers, senior managers,
and personnel specifically assigned to perform QA functions. The following is an overview of
the QA responsibilities of some of these Regional personnel:
1.4.1 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, dated 5/5/00. Specifically, the RA and Senior Managers are
responsible for ensuring that:
All Regional components and programs comply fully with the requirements of
EPA Order 5360.1 A2;
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 QA operations are developed, updated
and effectively implemented. QMPs are not required for the Offices of Regional
Counsel, Office of Communications and Government Relations and the Office of
Policy & Management;
All environmental data collection and data compilation activities are covered by
the appropriate documentation (i.e., Quality Assurance Project Plans, Sampling
and Analysis Plans, Quality Management Plans, Standard Operating Procedures
etc.);
All environmental programs implemented through extramural agreements comply
fully with applicable QA/QC requirements;
Training is available for State, local, and Tribal governments performing
environmental programs for EPA in the fundamental concepts and practices of
quality management and QA/QC that they may be expected by EPA to perform;
Internal management assessments are performed to ensure that programs comply
with QA requirements. Deficiencies highlighted in the assessments are
appropriately addressed;
Performance Agreements for supervisors, senior managers, and appropriate staff
contain performance measures that are commensurate with their assigned quality
management responsibilities;
The Division or Program Office is represented on the Regional QA Council by a
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RID 5360.1 A CHG 2
June 4, 2003
Quality Assurance Coordinator;
Disputes regarding quality system requirements, QA/QC procedures, assessments
or corrective actions are resolved.
1.4.2 Regional Quality Council (RQC)
The 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 all Division or Program Offices which generate and/or compile environmental
data. The primary responsibilities of the RQC are to:
Review and update the Region's QMP;
Provide assistance to Regional staff in the organization about QA/QC policies,
requirements, and procedures applicable to procurement;
Identify QA training needs for the Region;
Participate in assessments of Regional organizations conducting environmental
programs to determine the conformance of their mandatory quality systems to their
approved QMPs and the effectiveness of their implementation.
Establish QA priorities for each new fiscal year
1.4.3 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. The Senior Management Representative shall serve for a period of
two years. 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;
Resolves disputes regarding quality system requirements, QA/QC procedures,
assessments or corrective actions.
1.4.4 Regional Quality Assurance Manager (RQAM)
The RQAM has 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 EPA
Headquarters' Quality Staff Conference Call, National QA Conference, etc. Also,
serves as primary Regional liaison with the Quality Staff in EPA Headquarters and
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Rm 5360.1 A CHG 2
June 4,2003
the State QA contacts;
Providing expert assistance to Regional staff on QA/QC policies, requirements,
and procedures applicable to procurement and technical 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 programs to determine the conformance of their mandatory quality
systems to their approved QMPs and the effectiveness of their implementation;
Submitting the Annual QA Report and Workplan to Senior Regional Managers
and the Office of Environmental Information (OEI) Quality staff;
Authorizing individuals to review and approve QAPPs;
Providing and/or scheduling QA training and briefings;
Distributing Agency QA guidance documents, policies, and procedures;
Routinely reviewing the QA procedures within the Region and keep the RA and
senior managers apprized;
Facilitating the discussion of disputes regarding quality system requirements,
QA/QC procedures, assessments or corrective actions.
1.4.5 Regional Quality Assurance Officer (RQAO)
The RQAO serves as a technical QA expert within the Region. In the RQAM's absence,
the RQAO serves as the Region's liaison with the Quality Staff in EPA Headquarters. The
RQAO's primary responsibilities are to:
Provide technical assistance to Regional staff on QA/QC policies, requirements,
and procedures applicable to procurement and technical activities;
Review QAPPs submitted by holders of extramufal agreements (EAID's only);
Provide and/or schedule QA training;
Review and certify drinking water laboratories;
Administer the SDWA and NPDES Proficiency Testing (PT) studies;
Administer the Air Program Performance Evaluation studies; and
Participate in assessments of Regional and State QA programs to assure that they
adhere to their approved QMPs..
1.4.6 Quality Assurance Coordinator (QAC)
Each Division and Program Office, which collects and/or evaluates environmental data
has a 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 of his/her Division or Program Office's QMP;
Helps implement the Division or Program Office's QMP;
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Helps Project Managers and/or Project Officers resolve data quality issues with
contractors, grant recipients, and recipients of Interagency Agreements;
Consolidates Division or Program Office's QA information for the QA Annual
Report;
Participates in assessments of Regional and state QA programs to assure that they
adhere to their approved QMPs.
1.4.7 Quality Assurance Team (QAT)
The Quality Assurance Team (QAT) is located in the EAID Analytical Services and
Quality Assurance Branch (EAID/ASQAB). The QAT provides extensive QA support to the
Hazardous Site Cleanup Division. Limited QA assistance is also provided to the Water
Protection Division and Waste and Chemicals Management Division. The team's primary
responsibilities include:
Reviewing QAPPs for the Hazardous Site Cleanup Division (HSCD) and other
Regional programs defined in EAID/ASQAB negotiated Work Plans;
Providing technical assistance on QA/QC policies, requirements, and procedures
applicable to technical activities;
Participate in assessments of QA and QC activities within various Regional
Programs;
Develop Program-specific QA Guidance Documents and/or QA Directives;
Provide or schedule QA training courses.
1.4.8 Program Managers
Program Managers have technical expertise in a specific program area (i.e., TMDL,
permits, enforcement, etc.) and serve as the focal lead for environmental program. Program
Managers may be Branch Chiefs, Section Chiefs or Team Leaders. In this role, they must ensure
that:
All intramural and extramural projects within their program that involve the
collection and/or compilation of environmental data 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;
Cooperate with QA reviews or audits and submit requested information in a timely
manner;
Take appropriate corrective action recommended by audit findings; and
Discuss any QA concerns with the Divisional QA Coordinator and/or RQAM.
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1.4.9 Project Officers and Work Assignment Managers
Project Officers (POs) and Work Assignment Managers (WAMs) are assigned
responsibility for specific projects supported by EPA through contracts, grants or interagency
agreements (IAGs). This category includes Superfund Remedial Project Managers (RPMs) and
On-Scene Coordinators (OSCs) who are responsible for site specific monitoring projects, as well
as Project Officers and Project Managers in WPD, APD, and WCMD. Since POs and WAMs
may not be closely familiar with QA procedures, they are encouraged to work with their
Divisional QA Coordinator to ensure that QA requirements are addressed The specific
responsibilities of Project Officers and Work Assignment Managers are to ensure that:
All extramural projects which generate and/or compile environmentally related
data, adhere to QA requirements found in Regional and Divisional QMPs;
All grant recipients or contractors conducting a project which involves
environmental data collection and/or data compilation submit a QMP which
documents their quality system. The QMP must be approved before grant or
contract money is awarded;
All grant recipients or contractors conducting a project which involves
environmental data collection and/or data compilation have an approved QAPP
prior to initiating any data collection and/or data compilation;
For contracts, a Quality Assurance Review Form (EPA Form 1900) has to be
completed, and approved in writing by the RQAM, Project Officer and
Contracting Officer (see Chapter 4 for a description of specific procedures);
For grants, the decision memorandum has been completed to indicate whether QA
requirements should be applied;
Environmental 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.
1.4.10 ASQAB Lab Quality Assurance Officer (QAO)
The ASQAB Lab QAO is responsible for the design and management of ASQAB's
quality system. Specific responsibilities are as follows:
Assist ASQAB in establishing priorities, annual goals and measures of success;
Develop annual plans and schedules for internal audits, SOP review and revisions;
Notify ASQAB management of deficiencies in the quality system and monitor
corrective action;
Serve as the focal point for QA/QC and be responsible for the oversight of quality
control data (e.g., trend analysis);
Coordinate external audits of ASQAB (e.g., triennial SDWA inspection) and track
corrective actions;
Coordinate development of proficiency documentation procedures and protocols
including quality control policies, concerning ASQAB's participation in
performance sample studies, and analytical method review and validation;
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Coordinate, preparation and maintenance of ASQAB QA documents (e.g., Lab QA
Plan);
Develop a QA annual training plan including specific curriculum and provide
QA/QC orientation for new employees;
Assess and improve data review and evidence audits procedures for ASQAB's
analytical data including procedures to assure that necessary raw data is archived;
Review documentation and records for compliance to requirements and
consistency with EAID and Region III plans; and
Assist ASQAB in long-term QA/QC planning.
1.4.11 ASQAB Lab Technical Director (TD)
The ASQAB Lab Technical Director (TD) monitors lab technical operations and
conformance to ASQAB quality system components. Specific duties include:
Negotiate annual Workplan with Regional Clients and monitor progress in meet
ing customer needs;
Participate in yearly organization review including the review of ASQAB's quality
system;
Conduct technical system audits (TSAs) of technical operations (review of SOPs,
IDCs, MDLs, and PT sample performance and procedures and documentation
relative to the Lab Quality Manual and mandated Agency methods);
Participate in the development of quality system (data production) policies, and
update the Laboratory Quality Manual as necessary;
Monitor technical operations through conducting TSAs and the routine review of
case files;
Serve as technical mentor by conducting technical sessions to address analytical
issues/problems and providing training on the QM; and
Coordinate SDWA, NPDES and SF laboratory assessments and review of State
Laboratory Certification Programs.
1.4.12 Analytical Team
The Analytical Team is located in EAID/ASQAB. The Analytical Team provides
analytical services to the air, water and hazardous waste management programs in Region III.
The team's primary responsibilities include:
Analyzing various samples such as water, soils, sediments, .hazardous waste,
oil, tissue, and air;
c Providing technical assistance and scientific training for state and regulated
community inspectors and analysis;
Conducting laboratory inspections;
Providing support for criminal investigations and enforcement cases.
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1.4.13 Client Services Team
The Client Services Team is located in EAID/ASQAB. The Client Services Team serves
as the focal point for procurement of analytical services for environmental data collection
activities within the Region. The team'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.
1.4.14 Freshwater Biology Unit
The Freshwater Biology Unit is located in EAID/ASQAB. This unit conducts
bioassessments and toxicity testing. The unit's primary responsibilities include:
Fish and macroinvertebrate field surveys and collections;
Physical habitat assessments;
Identification of macroinvertebrates;
Acute and chronic freshwater toxicity tests
. 1.4.15 Office of Enforcement, Compliance and Environmental Justice (OECEJ)
Field Personnel
The Office of Enforcement, Compliance and Environmental Justice (OECEJ) includes a
staff of field personnel located in Fort Meade, Maryland;Wheeling, West Virginia and the
Philadelphia, Pennsylvania Regional Office. OECEJ field personnel conduct media specific and
multi-media compliance inspections. These inspections are done to support programs, such as
the Resource Conservation and Recovery Act (RCRA) Subtitles C and I; National Pollutant
Discharge Elimination System (NPDES); Toxic Substances Control Act (TSCA); and the
Emergency Planning and Community Right to Know Act (EPCRA). During these inspections,
OECEJ field personnel may collect samples to help identify whether a potential violation exists.
1.5 COMMUNICATIONS
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 disseminate QA
information. The Region III QMP will be posted on the Region's Intranet. On a regular basis, the
RQAM will keep the EAID Director, Senior Management Representative, RQAO, RQC and
Senior managers apprized 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.
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At a minimum, the RQC meets quarterly to discuss and resolve issues about QMP
implementation and its impact on data quality. The RQC will also discuss ways to improve the
Region's Quality System. The RQC is the primary cross-Divisional group for addressing QA
topics that impact the entire Region. The individual Divisions and Program Offices will
establish their own methods of communicating QA issues within their respective organizations.
Finally, each Division or Program Office will identify QA training needs for all Regional
personnel in their program who are responsible for environmental data activities. Senior
Managers must ensure that adequate resources are available to implement the Region III QA
Training Plan. The RQAM, Program Managers, RQAO, RQC and/or the QAT will develop
and/or schedule QA training. A list of core QA training courses can be found in Section 3.1.1.
1.6 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 unresolvable 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. The resolving officials will document the resolution and provide it
to the disputing parties.
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CHAPTER 2: QUALITY SYSTEM COMPONENTS
2.1 PRINCIPAL COMPONENTS OF THE 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's Quality System include program level and
project level. A list of these components is provided below:
Quality Management Plans
Laboratory Quality Manuals
Quality Assurance Annual Report and Work Plan
Quality System Status Reports
Quality Systems Assessments
Training Plans
Data Quality Objectives
Quality Assurance Project Plans
Standard Operating Procedures
Technical System Audits
Proficiency Testing Samples
Data Quality Assessments
2.2 QUALITY MANAGEMENT PLANS
2.2.1 Region III Quality Management Plans
The Region III QMP has been prepared by the RQC. This document describes the policies
and procedures being implemented to ensure that environmental data being generated by and for
the Region are of adequate quality for its intended use. This document complies with the
requirements found in the EPA Quality Manual (EPA Order 5360.1 Al) and EPA Order 5360.1
A2. The Region III QMP serves as the "umbrella" document for all Regional programs. This
QMP shall be reviewed and approved by all Division and Program Directors and the Regional
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 Region III QMP shall be
reviewed and updated, as necessary, on an annual basis.
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2.2.2 Division/Program Office Quality Management Plans
Each Region III Division and Program Office that conducts projects that involve the use of
environmental data shall prepare a 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 and EPA
Order 5360.1 A2. Division and Program QMP requirements may be more, but not less, stringent
than those presented in the Region III QMP. All Division/Program Office's QMPs must be
reviewed and approved by the RQAM, or designee. AH individuals who conduct QMP reviews
must complete the core courses found in Section 3.1.1. These individuals should also 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 the ability to adapt these applications to Agency QA requirements is also required. The
most recent version of the OEI Quality Staff QMP Checklist may be used to review these QMPs.
When there are organizational or policy changes that impact a Division or Program's quality
system, the Division/Program Office QMP shall be updated and submitted to the RQAM for
review and approval.
2.2.3 Quality Management Plans for Extramural Projects
Recipients of grants, cooperative agreements, contracts and interagency agreements that
involve the 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. These policies
and practices shall be documented in a QMP, or equivalent document. The QMP for grants
cooperative agreements and contracts shall be prepared in accordance with the most recent
version of EPA QA/R-2: EPA Requirements for Quality Management Plans. The content of the
QMP, or equivalent document for interagency agreements shall be negotiated by both parties.
The recipient's QMP shall be viewed and updated annually, or as needed.
Should there be multiple programs involved in a grant, cooperative agreement or contract
at the recipient's discretion, the recipient may submit a single QMP covering all of the programs
in the grant, cooperative agreement or contract or a separate QMP for each program receiving
grant, cooperative agreement or contract funds.
The extramural project QMP or combined QMP/QAPP shall be submitted to the RQAM
for review. The most recent version of the OEI Quality Staff QMP Checklist may be used to
review these QMPs. When applicable, Region III QA Coordinators shall facilitate their
organization's review of the technical activities and programs documented in QMP for
extramural projects being managed by their Division or Program Office. Prior to environmental
data collection or data compilation, the extramural project QMP or combined QMP/QAPP must
be approved by the RQAM.
Upon receipt of an extramural project QMP, the RQAM shall update the Region III QMP
Status Report. This report contains the name of the organization that submitted the QMP, the
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receipt date, the review status and the approval status. The updated Region III QMP Status
Report shall be sent to the Region III Office of Policy and Management Grants and Audit
Management Branch. The Grants and Audit Management Branch shall distribute the updated
QMP Status Reports to all EPA Grant Project Officers. EPA Project Officers shall use this
information to ensure that extramural agreements under their purview have fulfilled their EPA
QA requirements.
23 LABORATORY QUALITY MANUALS
2.3.1 Analytical Services and Quality Assurance Branch
The EAID Analytical Services and Quality Assurance Branch (ASQAB) Quality
Management System is based on the requirements of ISO 17025 General Requirements for the
Competency of Testing and Calibration Laboratories, and National Environmental Laboratory
Accreditation Conference (NELAC) Chapters 2 and 5. Analytical services provided by the EAID
Analytical Services and Quality Assurance Branch are documented in the "OASQA Laboratory
Quality Manual." This manual describes the laboratory's quality system policies and procedures.
23.2 Freshwater Biology Laboratory
The Laboratory Quality Manual for the EAID/ASQAB Freshwater Biology Laboratory
describes the management and technical, requirements of the bioassessments and toxicity testing
laboratory. This manual complies with the requirements found in ISO 17025 General
Requirements for the Competency of Testing and Calibration Laboratories. Each person
involved in the laboratory's operations shall be familiar with the Freshwater Biology
Laboratory's quality system and the technical requirements of the tests being conducted.
2.4 QA ANNUAL REPORT AND WORK PLAN
At least bi-annually, each Division and Program QA Coordinator shall prepare a QA
Report that summarizes the QA/QC activities being used to implement their program's quality
system. The RQAM consolidates this information into Region III QA reports. These
consolidated QA reports shall be distributed to the Senior Management Representative to the
RQC and each Region HI Division/Program QAC. At the end of each fiscal year, the RQAM
shall consolidate the information in the Region's QA reports into a QA Annual Report. The QA
Annual Report documents the Region's QA/QC activities (i.e., QA training, technical system
audits, quality system audits, QAPP reviews, quality system improvements, etc.) conducted
during the fiscal year. The content of the Region III QA Annual Report shall comply with the
requirements found in Chapter 4 of the EPA Quality Manual. Prior to the distribution of the QA
Annual Report to the Director of the EPA OEI Quality Staff, the report shall be reviewed and
approved by the Senior Management Representative to the RQC.
At the beginning of each fiscal year, the RQC shall establish a list of QA priorities for the
fiscal year. These QA priorities shall be documented in the QA Annual Report and Work Plan
(QAARWP) submitted to the Director of the EPA OEI Quality Staff. The Region III QA Work
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Plan shall also include a list of planned training courses, quality system audits and audit
responsibilities.
2.5 QUALITY SYSTEM STATUS REPORT
The Quality System Status Report provides a brief summary of the status of the Region's
compliance with the QA requirements found in EPA Order 5360.1 A2. This two page report
contains a table with a list of EPA QA requirements, the Region's QA activities conducted in the
previous year to fulfill these requirements, potential QA vulnerabilities and QA priorities for the
current year. A copy of this status report shall be included in the agenda and minutes of all RQC
meetings. The RQC shall use this report to monitor the Region's progress in implementation of
its quality system. The Council shall review and update the Quality System Status Report at least
once per quarter.
2.6 QUALITY SYSTEM AUDITS
The RQAM and the RQC shall evaluate the Region's conformance with the EPA Quality
Manual and EPA Order 5360.1 A2 annually. The scope of this audit shall be defined by the
RQAM and RQC. At a minimum, an evaluation of the Region's progress on the completion of
corrective actions from previous internal and external quality system audits shall be conducted
during this evaluation.
An in-depth quality system audit of each Division and Program Office in the Region's
quality system shall be conducted at least once every three years. This audit shall evaluate all of
the applicable elements of the organization's quality system. The RQAM shall be responsible for
assembling the audit team and coordinating audit activities. At a minimum, the audit team shall
consist of the RQAM or designee and at least one member of the RQC. The audit team may also
include a member of the EAID/ASQAB Quality Assurance Team and a representative from
outside the audited program. All members of the audit team shall be familiar with the QA
requirements found in EPA Order 5360.1 A2.
2.7 TRAINING PLANS
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 that participate in the Region's Quality System obtain information
about EPA QA requirements and understand their QA roles and responsibilities. Each Region III
Division and Program Office QAC shall receive information about QA requirements from the
Region III QA Manager and/or National Program Offices.
QA Coordinators shall assist their Division/Program Office in the identification of QA
training needs for the members of their organization. These QA training requirements shall be
documented in each Division/Program Office QMP. When QA responsibilities have been
defined, they shall be incorporated into performance standards.
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The implementation of QA requirements for extramural agreements is a critical
component of the Region's Quality System. Therefore, the RQC shall establish QA Training
requirements for Project Officers, Work Assignment Managers, etc. responsible for
implementing these tasks. The procedures found in the most recent version of EPA QA/G-10:
Guidance for Developing a QA Training Program may be used to develop these training plans.
Additional information about generic QA training requirements for all Region III
personnel can be found in Chapter 3 of this QMP.
2.8 DATA QUALITY OBJECTIVES PROCESS
The Region is committed to the generation of environmental data that is of adequate
quality for its intended use. All parties that generate environmental data for the Region shall use
a systematic planning process, such as the Data Quality Objectives (DQO) Process found in the
most recent version of EPA QA/G-4: Guidance for the Data Quality Objectives Process. The
results of the systematic planning process shall be documented in the project's QAPP.
When appropriate, each Division or Program Office may establish data quality objectives
for its ongoing programs. The EAID/ASQAB Quality Assurance Team may provide technical
assistance as warranted in determining the appropriateness of the DQO relative to the intended
use of the data. The RQAM, or designee, shall ensure that internal aii^ -"^ural project QMPs
require the use of the systematic pi^.^ ~
2.9 QUALITY ASSURANCE PROJECT PLANS (QAPPs)
The 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 must be approved prior to any environmental
data collection or compilation. 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" found in Section 2.4.2 of EPA QA/R-5:
EPA Requirements for Quality Assurance Project Plans for Environmental Data Operations. 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. For some environmental programs, a generic QAPP
may be acceptable. However, for all environmental projects conducted in the Region, the
applicable elements of EPA QA/R-5 shall be included in the QAPP.
For extramural projects, recipients of grants, cooperative agreements and Interagency
Agreements must submit a QAPP that conforms with the requirements found in the most recent
version of EPA QA/R-5. The QAPP must be submitted to the EPA Project Officer at least 30
days prior to the initiation of data collection or data compilation. The EPA Project Officer is
responsible for the approval of QAPPs. The decision to approve or reject a QAPP is based on
the Project Officer's technical expertise and the.comments received from QAPP reviewers. As
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noted above, the QAPP must be approved prior to environmental data collection or data
compilation.
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. These individuals should also 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 the ability
to adapt these applications to Agency QA requirements is also required. The QAPP Checklist
developed by the ASQAB Quality Assurance Team may be used for this review. To date, the
RQAM has not delegated the review and approval of QAPPs to any grant or cooperative
agreement recipient.
2.10 Standard Operating Procedures (SOPs)
A Standard Operating Procedure (SOP) is a set of written instructions that document a
routine or repetitive activity that shall be followed. The use of SOPs serves as a mechanism to
ensure comparability across programs and individual environmental data collection projects.
SOPs can describe both technical and administrative operational elements.
The information contained in the most recent version of EPA QA/G-6: Guidance for the
Preparation of Standard Operating Procedures (G-6) may be used to provide guidance on the
development and use of SOPs. Additional information about the development and use of SOPs
can be found in each Division or Office QMP. The RQAM or designee shall ensure that all
QMPs include the title(s) of the individual(s) responsible for the review and approval of SOPs.
2.11 Technical Systems Audits (TSA)
A technical systems audit is a systematic and objective examination of the facilities,
equipment, personnel, training, procedures, record-keeping, data validation, data management
and analysis, and reporting aspects of an environmental measurement system. The goal of the
TSA is to determine whether environmental data collection activities and related results comply
with the project's QAPP and other planning documents. Technical audits may also be used as an
investigative tool when problems are suspected.
All programs in the Region that employ environmental sample collection and analyses are
subject to a TSA. The most recent version of EPA QA/G-7: Guidance on Technical Audits and
Related Assessments 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 all QMPs include the title(s) of the individual(s) responsible for conducting TSAs.
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2.12 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, QATs laboratory, etc.) or found in the QAPP. The procedures being used
for the acquisition and evaluation of proficiency testing samples shall be included in either the
QMP, Laboratory Quality Manual or project QAPP.
2.13 Data Quality Assessments
A Data Quality Assessment (DQA) is the scientific evaluation of data to determine if data
obtained from environmental data operations are of the right type, quality, and quantity to
support their intended use. The most recent version of EPA QA/G-9: Guidance for Data Quality
Assessment may be used during the DQA. 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.
After the data has been subjected to this initial data review process, it shall be evaluated to
determine if the project's data quality objectives and sampling design criteria have been
achieved. Data validation reports, field and laboratory audit reports, proficiency testing sample
results and other quality control information may be used to make this determination. In
addition, various statistical tests (i.e., t-tests, quantile tests, etc.) may also be conducted to help
draw conclusions about the data.
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CHAPTER 3: QUALIFICATIONS AND TRAINING
It is Region Ill's policy to provide the QA and QC training necessary to ensure that all
persons involved in handling environmental data understand Region Ill's Quality System. All
Regional personnel involved with environmental data generation or use shall be required to have
the appropriate QA Training. It shall be the responsibility of the Directors of all Region m
Divisions and Program Offices to ensure that the individuals in their organizations meet the
minimum QA training requirements for their assigned activities. QA responsibilities are not
currently incorporated into performance standards, however, the emphasis on QA training should
have a greater impact on implementing the Region's QA policy statement and achieving the
Region's stated mission. The following sections describe Region Ill's QA training program and
the requirements for Regional personnel involved with environmental data use and generation.
3.1 REGION Ill's QA TRAINING PROGRAM
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 QMP. EPA
QA/G-10: Guidance for Developing a QA Training Program may be used as a tool. 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. These Region-
wide QA training courses may be given by the Region's Environmental Services Division,
another Region, other Federal Agencies, contractors or the OEI Quality Staff.
This section describes the core Region-wide QA training courses, the program logistics,
and the associated documentation.
3.1.1 Courses
Region III has identified below, the core QA courses that shall be offered to Region III
personnel and Region III state and local government agencies. More courses may be developed
as additional training needs are identified.
Orientation to the EPA Quality System: This course shall provide an overview of the EPA
Quality System, basic QA concepts, and a description of the application of these concepts to
environmental programs involving the collection or use of environmental data.
Introduction to Quality Management Plans: This course shall provide an overview of the
ten QMP elements found in QA/R-2. During this course, EPA's graded approach to QMP
development will also be emphasized.
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Introduction to the .Data Quality Objectives: This course shall provide an overview of the
Agency's systematic planning process. During this course, participants will not only learn the
seven steps of the Data Quality Objectives Process, but also the benefits of using the DQO
process for environmental projects.
Introduction to Quality Assurance Project Plans: This course shall provide an overview of
twenty-four QAPP elements found in QA/R-5. 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.
How to Prepare Standard Operating Procedures: This course shall provide information
about the purpose of a Standard Operating Procedure (SOP) and the recommended formats for
administrative and technical SOPs. Participants will also learn about the recommended process
for review and approval of SOPs.
3.1.2 Logistics
The Region III QA training nrr>orroปv. *- ... tnrough a conaouiauve enort
between the kcgiun ป anu tne RQC. Additional training support for non-routine topics
may be provided by the OEI Quality Staff, other Regions, local universities, contractors and
professional organizations. The Region Ill's Office of Policy and Management (OPM) shall
arrange for training announcements and training rooms.
3.1.3 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 the
courses shall be recorded. The Office of Policy and Management (OPM) shall maintain a record
of all QA 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.
The Regional 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 senior
management with a summary of the QA training courses that have been offered in the Region.
This information shall also be included in the Annual QA Report and Work Plan. This summary
shall include, but is not limited to the courses offered, the number of attendees (both EPA and
non-EPA), and a listing of all non-EPA participating organizations.
3.2 Training Requirements
One of the goals of the Region III training program is to ensure that the Region's Quality
System is being effectively implemented in a consistent manner throughout all Regional
programs and organizations. To accomplish this goal, all Region III personnel must have the
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appropriate knowledge of quality assurance policies, principles and procedures. Staff members
who are directly involved in the generation and/or use of environmental data are the primary
focus of the Region's QA training program. However, all individuals who are active participants
in the Region's Quality System shall be knowledgeable of the basic elements of the EPA Quality
System. Region Ill's training program incorporates a graded approach relative to the functions
performed by the various groups of personnel. This section outlines the minimum QA training
requirements for the various groups of personnel.
3.2.1 Regional Administrator and Senior Managers
Senior Managers are responsible for ensuring that the Region III Quality System is
implemented as described in this QMP and the resources are available to achieve these QA
requirements. Therefore, Senior Managers shall be knowledgeable of the QA requirements
described in the Region's "Orientation to the EPA Quality System" training course. Senior
Managers shall receive information about these QA requirements from the Region's Quality
System Status Report or during the RQC's Senior Management briefings.
3.2.2 Program Managers
Program Managers must ensure that all intramural and extramural projects within their
program that involve the collection and/or compilation of environmental data are performed in
accordance with the Regional and Divisional QMPs and an approved QAPP. Consequently, they
must be knowledgeable of the elements of the EPA Quality System. Program Managers are
required to attend an "Orientation to the EPA Quality System" training course or briefing.
Additional training may be required depending on the specific duties and responsibilities of the
individual. When additional QA training is required, Program Managers shall forward this
training request to their Division or Program Office QA Coordinator. These QA training
requests will be included in the Division or Program Office's annual QA training needs survey.
3.2.3 Project Officers and Work Assignment Managers
Project Officers (POs) .and Work Assignment Managers (WAMs) are assigned
responsibility for specific projects supported by EPA through contracts, grants or interagency
agreements (IAGs). Project Managers and WAMs must be knowledgeable of the elements of the
EPA Quality System. They shall be required to attend an "Orientation to the EPA Quality
System" training course or briefing. Additional training may be required depending on the
specific duties and responsibilities of the individual. An orientation to the EPA quality system
shall also be included in the Project Officer Certification Training. When additional QA training
is required, Project Managers and WAMs shall forward this training request to their Division or
Program Office QA Coordinator. These QA training requests will be included in the Division or
Program Office's annual QA training needs survey.
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3.2.4 Regional Quality Assurance Manager (RQAM)
With respect to QA training, the RQAM shall ensure that a summary of training offered
during the fiscal year is provided to senior management at the end of the fiscal year. Training
needs identified by EPA management and States shall be given consideration. At a minimum,
the RQAM must have successfully completed all of the core QA courses listed in Section 3.1.1.
In addition, the RQAM must complete a quality system audit training course.
3.2.5 Regional Quality Assurance Officer (RQAO)
The RQAO serves as a technical QA expert. In this role, the RQAO provides technical
assistance to Regional staff on QA/QC requirements and reviews QAPPs submitted by holders of
extramural agreements. In order to accomplish these roles, the RQAO must complete all of the
core QA courses listed in Section 3.1.1. In addition, the RQAO must complete a quality system
audit training course.
3.2.6 Quality Assurance Coordinators (QACs)
QACs are responsible for coordinating the implementation of the quality system in their
Division or Program Office. QACs shall also consolidate their program's QA training needs and
present this information to the RQC on an annual basis. At a minimum, QA Coordinators shall
complete the Orientation to the EPA Quality System, Introduction to Quality Management Plans
and Introduction to Quality Assurance Project Plans training courses. Additional training may be
required depending on the specific duties and responsibilities of the individual. When additional
QA training is required, these training requests will be included in the Division/Program Office's
annual QA training needs survey.
3.2.7 Quality Assurance Team
The EAID/ASQAB Quality Assurance Team provides extensive QA support to the
Hazardous Site Cleanup Division. Limited QA support is also provided to other Divisions and
Program Offices. This QA support includes reviewing QAPPs; providing technical assistance
and providing QA training. In order to accomplish these roles, all members of the Quality
Assurance Team must complete all of the core QA courses listed in Section 3.1.1. In addition, a
quality system audit training course must also be completed. Additional training may be required
depending on the individual's assigned duties and responsibilities. When additional QA training
is required, these training requests shall be forwarded to the EAID/ASQAB Associate Director.
These QA training requests may also be included in the Division or Program Office's annual QA
training needs survey.
3.2.8 Analytical Team and Freshwater Biology Staff
Members of these organizations conduct chemical and biological analyses and field
studies that support our Regional programs. Training requirements for individuals that conduct
these analyses are found in the laboratory's Quality Manual. When additional QA training is
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required, these training requests shall be forwarded to the appropriate Laboratory Director.
These QA training requests may also be included in the Division or Program Office's annual QA
training needs survey.
3.2.9 Client Services Team
The EAID/ASQAB Client Services Team serves as the focal point for the procurement of
analytical services for environmental data collection activities within the Region. At a minimum,
individuals on this team must complete an Orientation to the EPA Quality System training or
briefing. Additional training may be required depending on the individual's assigned duties and
responsibilities. When additional QA training is required, these training requests shall be
forwarded to the EAID/ASQAB Associate Director. These QA training requests may also be
included in the Division or Program Office's annual QA training needs survey.
3.3 Recertification
All persons who are actively involved in the Region's Quality System shall be required to
attend QA refresher courses every four years. The contents of these QA refresher courses shall
be determined by the year 2004.
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CHAPTER 4: PROCUREMENT OF ITEMS & SERVICES
4.1 ACQUISITIONS BY US GOVERNMENT CONTRACTING OFFICERS
EPA requires that all recipients of funds for work involving environmentally-related
measurements comply with the American National Standard ANSI/ASQC E4-1994. The EPA
Procurement Policy Notice: Guidance for Use of Higher-Level Contract Quality Requirements in
Acquisitions (March 2001) shall be used to develop a Region III QA form for defining the
contract quality requirements.
Contracting Officer's Representative (i.e., Project Officers, Deputy Project Officers,
Regional Project Officers, Zone Project Officers, Delivery Order Project Officers, Work
Assignment Managers, Task Order Managers, Technical Program Managers) and the RQAM will
use the Region III QA form to identify the appropriate QA requirements for the acquisition. The
QA form shall then be distributed to the Contracting Officer. The Contracting Officer shall use
the information on the Region III QA form to determine the appropriate QA clause from the
Integrated Contract Management System (ICMS) to include in the contract. This QA clause shall
require contractors to provide documentation of the organization's quality system and the
project's QA/QC requirements. The documentation of a contractor's quality system shall comply
with the most recent version of QA/R-2: EPA Requirements for Quality Management Plans.
The documentation of a contractor's project QA/QC requirements shall comply with the most
recent version of QA/R-5: EPA Requirements for Quality Assurance Project Plans.
Prior to the initiation of environmental data activities, the contractor's QMP and QAPP
must be approved. The QMP must be approved by the RQAM or designee. The RQAM shall
ensure that all Division/Program Office QMPs include the title(s) of the individual(s) responsible
for the approval of the contractor's QAPP.
For contracts consisting of a single project or task, a combined QMP/QAPP that describes
the organization's quality system and the application of the quality system to the work being
conducted in the contract may be submitted. The decision to use a combined QMP/QAPP can
only be made by the Contracting Officer's Representative (COR) and the RQAM or designee.
The RQAM, or designee shall identify the QA elements that must be addressed in the combined
QMP/QAPP. The combined QMP/QAPP must be approved by the RQAM or designee and the
COR prior to the initiation of environmental data activities.
For contracts or solicitations that cover similar activities being conducted at multiple
locations or over a long period of time, a Program QAPP may be submitted. The decision to
require a Program QAPP shall be made by the COR and the RQAM. The Program QAPP shall
describe common activities that are not site-specific, but those that are being applied throughout
the program. Site-specific QA activities shall be included in a site-specific Sampling and
.Analysis Plan (SAP). The Program QAPP and the SAP must be approved before environmental
data activities are initiated. The RQAM shall ensure that each Division/Program Office QMP
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includes the title(s) of the individual(s) responsible for the approval of the contractor's Program
QAPP and SAP.
If a contractor submits a Statement of Work (SOW) that involves environmental data
activities, the COR shall submit the SOW to the RQAM for review. The RQAM, or designee
shall review the draft SOW to ensure that the applicable QA requirements necessary to achieve
the project's data quality objectives have been included in the SOW. The results of this review
will be distributed to the COR. When applicable, the RQAM or designee shall also serve on
formal source selection technical panels. For an acquisition that involves Information
Technology hardware or software., the COR shall obtain the concurrence of Computer Services
Branch in the Region III OPM.
4.2 SMALL PURCHASES
Procurement of environmentally related measurements or data generation which quality
for small purchases under the Federal Acquisition Regulations (FAR) will be subject to QA
requirements. In Region III these actions are generally for analytical services obtained under the
regional Delivery of Analytical Services (DAS) Brokerage and by existing Headquarter's non-
Routine Analytical Services (non-RAS) contract for dioxin analysis.
Generally, an approved QAPP or similar documentation such as a SAP are used to create
an analytical services request for the procurement of analytical services. The requirement for a
QAPP and/or SAP should be included in the original contract award to study a site. Under the
direction of an EPA On Scene Coordinator (OSC), Regional Program Manager (RPM), or other
Project Manager/Project Officer, a request for analytical services is created by the contracted
field contractor and submitted to the Project Manager/Project Officer for approval.
The EAID DAS Brokerage Project Officer and the OSC or RPM of the Hazardous Site
Cleanup Division (HSCD) shall jointly prepare and review the analytical services request for
each procurement. This joint preparation and review consists of selecting the most cost effective
Field and Analytical Services Training Advisory Committee (FASTAC) contracting mechanism,
administrative site information component review, number of samples to be analyzed, methods
selected to characterize the site, parameters of interest, reporting limits, and stipulating the QA
Requirements as per the QAPP or SAP.
Once the joint review is completed, the DAS Brokerage Project Officer creates a bid form
for the solicitation of analytical services. Each bid form consists of the number of samples to be
analyzed, methods selected to characterize the site, parameters of interest, contract deliverables
and agreements, reporting limits, and Quality Assurance Requirements stipulated in the QAPP or
SAP. These bids are sent to regional participating commercial labs for price solicitation. All
commercial laboratories that receive this bid shall provide a copy of their laboratory's Quality
Manual. The EAID/ASQAB Client Services Team shall review this manual to ensure that the
laboratory's quality system conforms with the requirements found in the most recent version of
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ISO 17025, NELAC Chapter 5 or ANSI/ASQC Q2-1991. If the laboratory's documented quality
system is acceptable, the laboratory's solicited bid will be considered.
All acceptable bids shall be compiled and reviewed by the DAS Brokerage Project
Officer. Bids are reviewed to ensure that the laboratory's analytical procedures and QC
acceptance criteria meet the requirements found on the analytical request form. The DAS
Brokerage Project Officer will assure that a Procurement Request Package is complete and
provide it with a recommendation to the Procurement Contracting Officer for review and award.
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. The purchase of computer hardware must also conform with the
April 1, 1993 Executive Order Number 12845 titled Requiring the Agency to Purchase Energy
Efficient Computer Equipment.
4.3 GRANTS AND COOPERATIVE AGREEMENTS
All applicants for grants or cooperative agreements involving environmental data
collection or data compilation shall submit a QMP prepared in accordance with the specifications
provided in the most recent version of EPA QA/R-2: EPA Requirements for Quality
Management Plans, which describes the quality system implemented by the applicant. The EPA
Project Officer will indicate on the Funding Recommendation whether the project includes the
taking of environmentally related measurements or data generation. If it does, EPA will include
a term and condition in the assistance agreement. This term and condition requires the recipient
to submit the QMP within a specified time and notifies the recipient that they may not begin
work involving environmental data collection or compilation 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 data collection and data compilation. The QAPP should be prepared in accordance with the
specifications provided in the most recent version of EPA QA/R-5: EPA Requirements for
Quality Assurance Project Plans, which describes the quality assurance and quality control
activities to be implemented to satisfy the performance criteria for the work involving
environmental data collection and data compilation.
The Grants Specialist will assure that the terms and conditions are included in the
assistance agreements where QA requirements apply. The EPA Project Officer will assure that
the grantee complies with the conditions.
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The requirements for QA are contained in 40 CFR 30.54 for universities and other non-
profits, 40 CFR Part 31.45 for States, tribal, and local governments, and Regional Order 5361.5
Location Identification Policy and Responsibilities.
4.4 INTERAGENCY AGREEMENTS (IAGS)
All LAGs with environmental measurements activities which Region III funds, or
participates in, shall require an approved QMP, or equivalent document. The content of the
QMP, or equivalent document for interagency agreements shall be negotiated by both parties.
When Region III is providing funds to another organization, that organization is responsible for
preparing the QMP, or equivalent document. If the external organization's documented quality
system meets the requirements found in the most recent version of QA/R-2: EPA Requirements
for Quality Management Plans or the Intergovernmental Data Quality Task Force: Uniform
Federal Policy for Implementing Environmental Quality Systems (when implemented), their
QMP, or equivalent document shall be acceptable. If there are no comparable QA procedures,
the QA procedures agreeable to both parties must be negotiated for the LAG. Before any
environmental measurements or data collection activities can be performed, the external
organization must submit and have a QMP, or equivalent document and a QAPP approved or
successfully negotiated and acceptable to both parties.
In order to document compliance with the above policy, the EPA Project Officer shall
indicate in the LAG Program Decision Memorandum (Program Office Authorization for the
Award) if 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 to the EPA Project Officer a QMP and that EPA will review and concur on the QA
documents (e.g. QAPPs, SAPs and Workplan), which reflect environmental sampling and
laboratory analysis and Health and Safety Plans (HASPs).
After the IAG is executed by both parties it is the responsibility of the EPA Project Officer
to assure that the recipient of the IAG is in compliance with the QA condition(s). These QA
requirements shall be prepared in accordance with the specifications provided in the most recent
version of QA/R-2: EPA Requirements for Quality Management Plans or the Intergovernmental
Data Quality Task Force (IDQTF): Uniform Federal Policy for Implementing Environmental
Quality Systems and the IDQTF Uniform Federal Policy for Quality Assurance Project Plans or
QA/R-5: EPA Requirements for Quality Assurance Project Plans.
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CHAPTER 5: DOCUMENTATION AND RECORDS MANAGEMENT
Records include all books, papers, maps, photograph's, 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,
(from 44 U.S.C. Chapter 33, Sec. 3301).
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 programs, while providing adequate preservation of key records necessary to
support the mission of the Region.
It is Region Ill's plan to adopt and implement all Agency-approved records management
policies and guidance developed by the Office of Administration and Resources Management,
Office of Environmental Information (formerly the Office of Information Resources
Management). Region III adheres to the most recent version of the following guidance and
policies:
Records Management Manual (2160), U.S. Environmental Protection Agency, OIRM
IRM Policy Manual (2100), Chapter 10, Records Management, U.S. Environmental
Protection Agency, OIRM
IRM Policy Manual (2100A16), Chapter 8, Information Security, U.S. Environmental
Protection Agency, OIRM
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
Project level quality-related documents and records (both printed and electronic) will be
identified by the EPA Project Manager/Project Officer. Regional quality-related documents and
records will be identified by the RQAM. It is the responsibility of the person identifying quality-
related documents and records to manage and control those documents and records (or cause
them to be managed and controlled), in accordance with the guidance and policies listed above.
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The RQC is responsible for preparing, issuing and revising the Region III QMP. The
Region III QMP shall conform with the requirements found in the EPA Quality Manual for
Environmental Programs (5360.1 A1). Prior to the dissemination of this QMP, it will be
reviewed and approved by Region III Senior Managers, the Region III Administrator and the
Director of the EPA OEI Quality Staff or designee. When a revised Region III QMP is approved,
a notice will be sent to all Senior Managers for distribution to their staff. The obsolete version of
the Region III QMP posted on the Region III website will be removed and the current version of
the Region III QMP will be posted.
Each Division and Program Office that is responsible for environmental data activities
shall prepare a QMP. The Division or Program Office QMP shall conform with the requirements
found in the EPA Quality Manual for Environmental Programs (5360.1 Al). Division and
Program Office QMPs are reviewed by the RQAM or designee. After these QMPs are approved
by the RQAM, they are returned to the Division or Program Office QA Coordinator. The QA
Coordinator maintains the QMP in accordance with the procedures specified in the approved
QMP. When a revised Division or Program Office QMP is approved, the older version of this
document is removed from circulation.
QMPs for extramural projects are reviewed and approved by the RQAM. After these
QMPs are approved, they are returned to the Project Officer. Information about the review,
approval, distribution, retention and disposition of approved QAPPs and other QA-related
documents (i.e., chain of custody and evidentiary records, etc.) can be found in each
Division/Program Office approved QMP.
The Project Officer is responsible for managing all project level 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 procedures specified in their
Division/Program Office QMP. The Project Officer is also responsible for ensuring that records
and documents accurately reflect completed work. The RQAM is 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 listed above. Each Division and Program Office is responsible for managing the
custody and confidentiality of eyidentiary 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.
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CHAPTER 6: COMPUTER HARDWARE AND SOFTWARE
In order to ensure the effective and efficient use of the Regional Automated Data
Processing (ADP) systems, including hardware and software system design, development,
implementation and maintenance, Region III will comply with all EPA standards and regulations
pertaining to hardware, software, system development, and data. It is a Region III goal to achieve
consistency in the way data are generated, compiled, stored and disseminated across all Regional
programs.
6.1 COMPUTER HARDWARE/SOFTWARE REQUIREMENTS
Region III managers and staff will comply with all hardware and software standards
delineated in the Office of Environmental Information's Guidance on Hardware and Software
Standards. These standards address Compatibility, Hardware, Operating systems,
Communication, Database Management, User Interface/Printer Interface, Application
Development and Applications. This includes those policies and requirements related to the
Americans with Disabilities Act. Bankcard procurement will also follow the Region's specified
procedures.
Region III will procure Agency-approved hardware and software that conforms with
Agency information management architecture standards and complies with EPA Directive 2100.
Prior to any purchases, the PC Site Coordinator and/or LAN Manager will evaluate requested
software and hardware to determine its conformance to Agency standards, compatibility with
existing products and services, performance capabilities and impact on the existing
infrastructure. PC Site Coordinator will approve purchases only if it meets all of the above
requirements.
Installation and maintenance follow Agency guidelines, with emphasis being on security .
issues. We assess the impact on the user community by staying in touch with them and noting
their complaints and requests. System performance is monitored continually. If a system change
adversely impacts performance, we make any necessary adjustments or Undo the change.
6.2 SYSTEM DEVELOPMENT
All Region III Information Resource Management (IRM) system development,
enhancement and modernization efforts will comply with EPA Directive 2100, Information
Resources Management Policy Manual. This compliance should include a systematic and
comprehensive dialogue between the data providers, data/system users and system developers,
prior to the design of the system in order to ensure extensive user participation and a systematic
approach to the design.
All software systems shall be operated and maintained according to EPA Directive 2100.
Compliance with applicable IRM Standards as outlined in Region Ill's System Design and
Development Guidance documentation will ensure that all hardware and software configurations
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are tested. For proper implementation and maintenance of the ADP system, the appropriate
Divisions/Program Offices shall provide:
A written description of the computer system(s) hardware and written operating
procedures for routine maintenance operations. Documentation should be developed
to include a written description of the computer system(s) hardware and written
operating procedures which describe the routine operation, maintenance and testing, to
ensure that both the hardware and software in use is accurately performing the
intended functions;
A written document which contains a detailed description of the software in use,
including the listing of all algorithms or formulas used for data generation, processing
and assessment, clear guidelines for data acceptance criteria, criteria for data
validation/invalidation, data deletion/addition, and data correction; and
Standard Operating Procedures which describe the routine operation, maintenance and
testing, to ensure that both the hardware and software in use is accurately performing
the intended functions.
These documents should be readily available in the areas where these procedures will be
performed. Changes in any part of the operating procedures shall be properly authorized,
reviewed and accepted in writing by the designated responsible person.
The Information Services Branch (ISB) in the Office of Policy and Management
documents procedures and maintains those systems which it develops. It is anticipated that by
January 2003, SOPs will be formalized and distributed to ISB and Division software developers.
Divisions that develop systems using their own staff or contractors are responsible for
documenting procedures and maintaining their systems. For example, the Chesapeake Bay
Program Office has developed a Chesapeake Information Management System (CIMS)
development protocol to improve development, review, testing, and acceptance of new hardware,
software or procedural systems or subsystems being used by the CBPO. This protocol is
comprised of fourteen steps. A description of this protocol can be found in the Chesapeake
Information Management System Major Project 14 Point Development Protocol (Bahner, 1999).
6.3 DATA STANDARDS
To take full advantage of the Region's growing technological and data resources, there
needs to be an increased emphasis on improving compatibility of data among the systems. For
consistent definition of data, and to facilitate cross-media use of data, all data produced or
collected by the computers shall be managed as specified in the Agency IRM Policy manual.
Region III will incorporate Agency data standards as listed in the Agency Catalogue of Data
Policies and Standards. This catalog will summarize Federal data policies and standards which
are" the definitive list of data standards that Agency personnel, contractors, grantees, and other
governmental organizations must meet when developing information systems. Critical standards
that will be followed include:
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Chemical Abstract Service Registry Number Data Standard, EPA Order 2180.1, June 26, 1987;
Data Standards for the Electronic Transmission of Laboratory Measurement Results,
EPA Order 2180.2, December 10,1987;
The Minimum Set of Data Elements for Ground Water Quality, Policy Order
74500.IA, September 11,1989;
Facility Identification Data Standard, U.S. EPA Office of Administration and
Resources Management, Information Management and Services Division, April 9,
1990;
Policy on Electronic Reporting, U.S. EPA Office of Administration and Resources
Management, July 30,1990;
Site Location Identification Policy and Responsibilities, Region III Order 5361.5,
September 14, 1988;
Locational Data Policy, IRM Policy Manual, Chapter 13, April 1991;
Locational Data Policy Implementation Guidance - Guide to the Policy, U.S. EPA
Office of Information and Resources Management, March 1992.
EPA's data-related policies apply to all EPA organizations and personnel, including
contractors, grantees and other governmental organizations who design, implement, and maintain
information management systems for Region III. The Region will incorporate Agency data
standards into all data collection activities and into new or modernized information management
systems.
6.4 INFORMATION SECURITY
It is important that the Region's information resources are protected from potential loss
and misuse from a variety of accidental and deliberate causes. To ensure this, the Region will
safeguard all information resources as specified in the EPA Security Manual. Technical staff
will assure that all servers meet the Office of Environmental Information's security standards and
that all virus programs are kept current and virus definition files are deployed in a timely manner
to servers and workstations.
The Region will continue to expand the Regional Security Program. An Information
Security Officer (ISO) has been named and tasked with this responsibility as well as maintaining
a Regional Security Plan. Security awareness training and information will be provided to all
employees on a regular basis and all new employees are now required to take the Agency's
security awareness training.
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6.5 GEOGRAPHIC INFORMATION SYSTEMS (GIS)
QA issues within the Geographic Information Systems team are concentrated into three
distinct areas: project management, primary data, and secondary use products. Each of these
areas will be addressed individually.
6.5.1 Project Management
The GIS Team is currently comprised of one EPA Team Leader, seven on-site contractor
GIS analysts and one contractor GIS analyst assigned to the Wheeling, WV office. The
contractor employees are funded through an Interagency Agreement with the General Services
Administration (GSA). The internal hiring processes of the contractor ensure only individuals
who possess the necessary skills are brought on board. GSA ensures that very specific
requirements have been established to ensure candidates have received the proper academic and,
where applicable, on-the-job training prior to being accepted as candidates. Once hired, each
person is educated on EPA procedures by the on-site contractor task leader. Additionally, ample
opportunities for continuing education and training are afforded all members through EPA-
sponsored meetings, vendor training courses, and contractor-induced incentives.
Each GIS project is given a project number and, if user requirements are such that written
instructions or reference information are included, a project file folder is created and all pertinent
documents filed. Once a project is completed, it is archived using programs written to compress
the electronic files and copy them to CD or tape for off-line storage. Projects can be "un-
archived" if necessary.
6.5.2 Primary Data
The GIS Team in EPA Region III "creates" very little data. Virtually all primary data has
been obtained from outside sources. These sources include other federal agencies, state, county,
and local governments, non-profit groups, and academic institutions. Primary data is defined as
"general base map" information (roads, railroads, streams and rivers, political boundaries, etc.)
and "specific map" information (state game lands, historic places, soil types, etc.). With few
exceptions, Region III relies on these groups to ensure the quality of their data prior to
distribution.
Additionally, the GIS Team's quality assurance concern is focused primarily on the
"spatial" component rather than the "descriptive" attributes. The spatial component is the X-Y
location values in two-dimensional space. These values can be in many forms, including several
varieties of geographic coordinates (degrees+minutes+seconds, decimal degrees, decimal
minutes), individual state plane coordinate systems, and a host of other map projections in both
the English and metric systems.
While the Region III GIS Team generates very little data on its own, EPA as an agency
maintains several databases that are used in environmental mapping projects. These include
CERCLIS, RCRAInfo, TRIS, SDWIS, PCS, and several others. Historically, the spatial
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component of these databases has been poor. Created prior to the introduction of computer
mapping software, collecting geographic coordinate information for sites and facilities was not
given a high priority. Most of EPA's databases have place holders for coordinates but for a
variety of reasons have been either left blank or been populated with easily identified surrogate
information such as the latitudes and longitudes of nearby post offices or county and zip code
centroid. The historical QA/QC is also suspect. When placed on maps, many sites and facilities
appear in the ocean, in Europe, Asia, and on occasion, the north and south poles. A closer
inspection of the coordinates reveals transposed values (latitude values in the longitude field and
vice versa), impossible values (latitudes greater than 90 degrees), negative values where positive
values should appear, zero values and other similar problems.
This "oversight" has led to several efforts to improve the quality of the coordinate
information in these databases. The most recent is the Locational Data Improvement Project or
"LDIP." The Region III GIS Team is participating in this project by using aerial photography,
address-matching software, and telephone calls to facilities. The new information, if it is deemed
"better" than what already exists, is forwarded to EPA headquarters where it is incorporated into
the Locational Reference Table, a temporary holding area for coordinate information until
mechanisms are put in place to update the main EPA databases. The update process is slow
because there is still much debate about what is the actual location of sites and facilities. The
answer seems to be "it depends on the intended use." .
Metadata, or "data about data", is an important part of the total data set. It is here that
information about collection methods, dates, scales, responsible parties, etc. are listed. The GIS
Team maintains a searchable web presence of all metadata records which is freely usable over the
EPA Intranet. It is the intention of the GIS Team to eventually make all the metadata Federal
Geographic Data Committee-compliant. However, this is a slow and tedious process requiring
many hours of labor. Initially a "scaled-down" set of metadata is kept on each electronic data file
providing users the bare-bones facts about that particular data set.
A general disclaimer about the quality and reliability of each data layer is posted on the
web site under the "Data Catalog" section. However, other than this disclaimer, qualifications in
the metadata on the GIS Team web page, and verbal correspondence with the individual clients
there is not much effort put into identifying data problems with the descriptive attributes. It is
assumed to be the responsibility of the individual clients to understand their data, its appropriate
use and any inherent limitations.
6.53 Secondary Use Products
Paper maps and programmed applications make up the bulk of the what are considered
"secondary use products." There are several quality assurance initiatives in place that ensure that
only accurate products leave the GIS Team shop. All maps are reviewed and checked by the
author and two other GIS Team members for spelling, map element positioning (scale bars, north
arrows, etc.), colors, and overall readability. Maps are then reviewed by the client before final
delivery.
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Because map production is part science and part art, liberal latitudes are given to the GIS
analysts to develop their own styles within the boundaries of sound cartographic principles.
Based on the intended audience for the map and the message the client is trying to impart, sizes,
shapes, colors, fonts, line weights, labels, etc. are left to the discretion of the analyst.
6.5.4 Summary
The Region III GIS Team creates very little data. It is, however, heavily involved in
efforts to correct existing latitude and longitude value problems with EPA databases. Secondary
use products are checked by several trained individuals before being handed over to clients.
Project folders and archives are kept for each GIS project. Only qualified individuals are hired as
GIS Analysts.
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CHAPTER 7: PLANNING
The major goal of Region Ill's Quality System is to promote effective planning for the
collection, analysis and processing of environmental data. Quality planning must occur at three
levels to ensure that such data meets Regional programmatic and quality goals: Region-Wide,
Program-Specific and Project Level.
7.1 REGION-WIDE PLANNING
7.1.1 Internal Strategic Planning
The Regional Strategic Plan is the foundation for all programmatic priorities and for all
environmental data collection and use. Using the projected annual budget for the Region, and
guidance from the various program offices in EPA Headquarters, the Regional Administrator and
the senior managers meet early in the fiscal year to set Regional priorities. These priorities are
then reflected in the Regional Strategic Plan, which establishes program goals, resource
utilization plans and budget allocations. Yearly action plans developed by the individual
Divisions, tied to the Strategic Plan and budget distribution process, further specify the types of
environmental data generation activities that will occur and the corresponding requirements for
QA and QC procedures.
7.1.2 External Data Coordination
The Region also coordinates the collection and use of environmental data 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.
7.1.3 Annual QA Report and Work Plan
During October of each year, the RQAM will prepare a QA Report and Work Plan
(QAARWP). The Report will summarize the past fiscal year accomplishments and the Work
Plan will outline planned QA actions for the upcoming year. Included in the Report will be a
description of specific audits and evaluations. The QAARWP will be submitted to the QA
Council and to the Region's senior managers for their review and approval.
7.2 PROGRAM-SPECIFIC PLANNING
Programs are functional areas of work authorized by Statutory reference (e.g., the Air
Toxics Program) or by Executive or Agency direction (i.e., the Volunteer Monitoring Program).
All of the Regional environmental programs that generate environmental data are covered by this
QMP, though not all require the same level of QA. When initiating a new program or
incorporating major statutory changes, the program shall establish the minimum quality system
components required to achieve the program requirements.
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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
use these national program documents. Any modifications or deviations from these documents
shall be documented.
7.3 PROJECT LEVEL PLANNING
A project is an organized set of activities within a program. The QAPP is the primary
vehicle for ensuring adequate data quality at the project level (see Chapter 2, Section 2.9 for a
more complete discussion of the QAPP development and review process). All projects and tasks
involving the generation or use of environmental data that are conducted by or for Region Project
Level Planning (PLP) shall have an approved QAPP in place prior to the start of data generation
or use. The Project Manager/Project Officer is responsible for ensuring that a systematic
planning process is used and documented. Guidance and technical support in using a systematic
planning process may be provided by the EAID/ASQAB Quality Assurance Team as requested.
The key to good quality planning at this level is to link the data collection directly to the
environmental decision to be made. Achieving this connection requires a dialogue between the
decision maker and the data supplier. Consequently, all stakeholders shall be involved in the
systematic planning process. Division or Program Office QA Coordinators, with assistance as
necessary from the RQAM, RQAO or EAID/ASQAB Quality Assurance Team may be involved
in the systematic planning process. The most recent version of EPA QA/G-4: Guidance for the
Data Quality Objectives Process may be used to assist in the development of the project goals,
objectives, type and quantity of data needed to support the decision and the acceptance and
performance criteria for measuring quality. The results of this systematic planning process shall
be documented in a QAPP.
7.3.1 Quality Assurance Project Plan Preparation, Review, and Approval
QAPP shall be prepared in accordance with the most recent version of QA/R-5: EPA
Requirements for Quality Assurance Project Plans. At a minimum, the QAPP shall include the
project objectives; project organization; data generation and acquisition procedures; assessment
and oversight procedures and data validation and usability criteria. This requirement applies to
all QAPPs prepared for projects or tasks involving environmental data to be performed by
Regional staff or through grants, cooperative agreements (40 CFR Parts 30, 31, and 35), and
contracts (48 CFR Chapter 15, Part 1546) and Interagency Agreements. The Region uses the
"graded approach" to determine the level of detail required.
EPA QA/G-5: Guidance on Quality Assurance Project Plans may also be used during the
QAPP development process. In addition, the QAPP Checklist developed by the EAID/ASQAB
Quality Assurance Team may be used as a tool in the development and/or review of QAPPs.
Project Managers/Project Officers shall ensure that QAPPs are developed for all projects under -
their jurisdiction. Project Managers/Project Officers are responsible for approval of QA Project
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Plans. The decision to approve or reject a QAPP is based on the Project Manager/Project
Officer's technical expertise and the comments received from QA Project Plan reviewers
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. These individuals should also 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 the ability
to adapt these applications to Agency QA requirements is also required. The QAPP Checklist
developed by the ASQAB Quality Assurance Team 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. 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
approve the QAPP, sign it and include it in the project file. The decision to approve or reject a
QAPP is based on the Project Manager/Project Officer's technical expertise and the comments
received from QAPP reviewers. Revisions to the approved QAPP shall be documented in a
second or subsequent revision or an addendum. However, 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 Officer or Project Manager) 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. For continuous projects, the
Project Manager/Project Officer shall ensure that the approved QAPP is updated every three to
five years. 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.
73.2 Generic Quality Assurance Project Plans
For multiple projects or sites with the same objectives and environmental decision(s), a
generic QAPP may be prepared. A generic QAPP shall adhere to the QAPP requirements
specified in Section 7.3.1. The generic QAPP shall include the elements which remain constant
among the different projects or sites. Most generic QAPPs will be supported by a site-specific
or project-specific plan which address the QA elements that are unique to each site or project.
The generic QAPP shall include the procedures being used for the preparation, review, and
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approval of the site-specific or project-specific plan. The appropriateness of a generic QAPP is
determined on case-by-case basis by the Project Manager/Project Officer in cooperation with the
RQAM, RQAO or EAID/ASQAB Quality Assurance Team. The Project Manager/Project
Officer is responsible for the approval of generic QAPPs. The decision to approve or reject a
QAPP is based on the Project Manager/Project Officer's technical expertise and the comments
received from QAPP reviewers
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. These individuals should also 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 the ability
to adapt these applications to Agency QA requirements is also required. The QAPP Checklist
developed by the ASQAB Quality Assurance Team may be used for this review.
The Project Manager/Project Officer is responsible for the approval of site-specific and
project-specific plans. The decision to approve or reject a site-specific and project-specific plan
is based on the Project Manager/Project Officer's technical expertise and the comments received
from QAPP reviewers. If the site-specific or project-specific plan contains analytical and/or
sampling procedures that are not found in the generic QAPP, the site-specific or project-specific
plan must be reviewed in accordance with the procedures documented in the appropriate
Division/Program Office QMP.
7.3.3 Secondary Data
According to EPA Order 5360.1 A2, secondary 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. If a project intends to use secondary data, the project
QAPP shall:
Identify the types of secondary data needed for project implementation or decision
making;
Describe the intended use of the secondary data;
Define the acceptance criteria for the use of secondary data;
Specify any limitations on the use of the secondary data;
Identify the individual(s) responsible for evaluating and qualifying the secondary data.
The Project Manager/Project Officer is responsible for ensuring that the issue of secondary
data is addressed in a project-specific QAPP. For those projects which involve the compiling
and use of secondary data 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
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secondary data projects may be provided by the RQAM or the EAID/ASQAB Quality Assurance
Team as needed. The Project Manager/Project Officer is responsible for ensuring a QAPP is
prepared for these types of environmental data projects.
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CHAPTER 8: IMPLEMENTATION OF WORK PROCESSES
The implementation of the procedures specified in this section shall ensure that all
environmental data activities being conducted within the Region conform to the requirements
found in this QMP, EPA Quality Manual and the EPA Order 5360.1 A2. These procedures are
currently being implemented at the program and project level.
8.1 PROGRAM IMPLEMENTATION
Annually, the Region III QMP shall be reviewed by the RQC to ensure that the
documented QA policies and procedures are accurate. The Region HI QMP shall also be
reviewed whenever there is a major reorganization or there are significant changes that impact
the Region's Quality System. In addition, every three 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 comment. After
Senior Management approval of the revised QMP, the document shall be distributed to the
Regional Administrator for review and comment. After the QMP has been approved by the
Regional Administrator, it shall be distributed to the Director of the OEI Quality Staff for review
and approval. After final approval has been received, the approved QMP shall be distributed to
EPA Senior Managers and the RQC. An e-mail announcement about the newly approved Region
III QMP shall be sent from the Senior Management Representative to the RQC. The obsolete
version of the Region III QMP shall be removed from the Region's QA website and the newly
approved version shall be added.
Annually, each Division Or Program Office QA Coordinator shall review their
organization's QMP. Division or Program Office QMPs are also reviewed whenever there is a
major reorganization or a significant organizational change that impacts the Division or Office
quality system. Every three years, Division and Program Office QMPs undergo a more thorough
review. If revisions are required, the QA Coordinator shall revise their organization's QMP and
distribute it to the RQAM for review and comment. The RQAM is responsible for the approval
of the Division and Program Office QMPs. After the QMP has been approved, it shall be
distributed to managers and supervisors. Older versions of Division and Program Office QMPs
shall be removed from circulation.
Approved QMPs for extramural projects shall be updated every three years, or whenever
there are major organizational changes that impact the documented quality system. Grantees and
contractors are required to review their QMP annually. If revisions are required, the revised
QMP shall be submitted to EPA Region III for review and approval in accordance with the
procedures specified in Section 2.2.1.3. The State QMP Status Report is used to document the
approval status of QMPs for extramural projects.
Annually, the Region shall submit a QAARWP to the Director of the OEI Quality Staff.
The QA report will summarize the QA management resources, training, quality system-related
accomplishments (i.e., innovative practices, technical assessments, QMP revisions, QA guidance, .
technical assistance, etc.) and quality system audits that have been conducted in the previous
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fiscal year. The QAARWP will include a list of QA activities planned for the upcoming fiscal
year. Each Division or Program Office that is a part of the Region's Quality System shall
provide information for the Region III QAARWP. Prior to submission to the OEI Quality Staff,
"the QAARWP shall be reviewed by the Regional Administrator or his designee.
8.2 PROJECT IMPLEMENTATION
8.2.1 Quality Assurance Project Plans
EPA Region HI shall conform to the requirements found in EPA Order 5360.1 A2. More
detailed information about the implementation of this project requirement can be found in
Chapter 2. Whenever there is a major project reorganization or there are significant changes that
impact the QA/QC procedures documented in the QAPP, the QAPP shall be revised. In addition,
every three to five years, based upon the original approval date, the QAPP must be reviewed to
ensure that the documented procedures are still accurate. If a revision is required, the revised
QAPP shall be submitted to the Project Manager/Project Officer for review. The EPA Project
Manager/Project Officer is responsible for the approval of QAPPs. The decision to approve or
reject a QAPP is based on the Project Officer's technical expertise and the comments received
from QAPP reviewers. As noted above, the QAPP must be approved prior to environmental data
collection or data compilation.
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. These individuals should also 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 QA and the ability to adapt
these applications to Agency QA requirements is also required. The QAPP Checklist developed
by the ASQAB QA Team may be used for this review.
After 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 the project's
technical system audit that occurs after the changes have been implemented.
8.2.2 Standard Operating Procedures
SOPs can describe both technical and administrative operational elements. It is
recommended that SOPs have a control documentation notation that includes the SOP title and
identification number, the revision number and the revision date. In order for SOPs to accurately
reflect current procedures, it is further recommended that SOPs be reviewed every three years.
The RQAM shall ensure that the procedures each Division or Program Office uses to develop,
review, approve and implement SOPs is found in the Division or Program Office QMP.
Additional information about SOPs can be found in Section 2.10.
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The Office of Enforcement, Compliance and Environmental Justice (OECEJ) Field
Inspection Program has developed SOPs that describe the procedures for ambient monitoring and
the collection of outfall (wastewater) samples. OECEJ field personnel have also developed SOPs
that describe the procedures to be used to conduct opportunistic sampling during a compliance
and/or multi-media inspection. A list of these SOPs can be found in the Appendix of this
document. The Program Manager for the OECEJ Field Inspection Program is responsible for the
review and approval of these SOPs.
8.2.3 EPA- Region III Users' Guide for Acquiring Analytical Services
The EAID/ASQAB Client Services Team has developed a users' guide for acquiring
analytical services. This guide includes a list of analytical services available and the various
acquisition mechanisms for obtaining these services. A detailed description of the procedures to
be followed for requesting and scheduling these services is also provided. The Users' Guide also
includes detailed procedures for completing field and shipping documentation. A copy of this
document is available from the EAID/ASQAB Client Services Team.
8.2.4 Region III OASQA Sample Submission Guidelines
These guidelines have been prepared to document the procedures that are to be followed
when submitting samples to the ASQAB Laboratory located at Ft. Meade, Maryland. The use of
the procedures specified in these guidelines help ensure that the field and laboratory aspects of
the sampling event produce data of known quality. The appendix of this document contains
information about sample requirements, nominal quantitation limits and chain of custody
requirements. A copy of this document is available from the EAID/ASQAB Analytical Team.
8.2.5 Inspections
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
consider "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
OECEJ Field Inspection Program. For inspections being conducted to support criminal
investigations, the Criminal Investigation Division (CID) investigator in charge of the case
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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 site's RPM 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 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 site's approved QAPP and/or SAP are discussed
with the site's 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 type of sampling activities, the Region uses a generic SAP
developed by the PA Department of Environmental Protection (PADEP) for ambient water
quality monitoring projects. This SAP was reviewed by OECEJ field personnel and approved by
the EPA Project Officer. Data analysis and preparation of the final report shall be conducted by
the EPA Project Officer.
Samples collected for compliance and multi-media inspections are transported to the
Regional Laboratory (EAID/ASQAB). Occasionally, samples are shipped to a laboratory that is
secured by the EAID/ASQAB Client Services Team. 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
report shall include the inspector's conclusions regarding the data and its regulatory implication.
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CHAPTER 9: ASSESSMENT AND RESPONSE
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
reviews and assessments evaluate the conformance of the Region's Quality System with the
procedures described in this QMP. The Region is committed to using the results of these
assessments to make operational changes that improve our existing quality system.
9.1 QUALITY SYSTEM ASSESSMENTS (QSA)
9.1.1 Internal Quality System Assessments
An annual assessment of the Region's Quality System shall be conducted by the RQAM,
or designee and the RQC. The scope of this annual assessment shall be determined by the
RQAM and RQC. The results of this annual assessment shall be documented in the Region's
QA Status Report. The RQC shall use this information to determine the QA priorities for the
following year.
In addition, a formal QSA of each Division or Program Office that is a part of the quality
system shall be conducted every three years. Information found in the most recent version of
EPA QA/G-3: Guidance on Assessing Quality Systems may be used in the development of the
QSA. The use of standard checklists developed by the RQAM help ensure that the appropriate
QA requirements are evaluated during the QSA.
All members of the QSA team must complete the Orientation to the EPA Quality System
training course described in Section 3.1.1. In addition, members of the audit team are
encouraged to attend a quality system audit training course. The RQAM and RQC may request
assistance from the EAID/ASQAB Quality Assurance Team to supplement the experience and
technical knowledge of the QSA review team.
The QSA Team shall determine the scope of the audit and the tentative QSA schedule.
Typically, the RQAM, or designee serves as the QSA team leader. The audited Division or
Program Office's QA Coordinator shall assist the QSA Team in handling the logistics of the
QSA and scheduling interviews. The Senior Management Representative to the RQC shall be
responsible for sending QSA notifications, Findings Reports and requests for Corrective Action
Plans to the Division or Program Office Director.
During the QSA, managers and active participants in the organization's quality system are
interviewed. In addition, QA files, previous audit reports and corrective action plans are also
reviewed. The results of the QSA shall be documented in a Draft Findings Report. Findings
may include objective evidence of non-conformance with the organization's quality system or
noteworthy accomplishments.
Upon completion of the audit, the preliminary results of the internal QSA shall be shared
with the Division or Program Office's Senior Management. Within 45 days, the audit team shall
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submit a written draft findings report to the Division or Program Office's Senior Management.
The Division or Program Office shall review the draft findings report to ensure it accurately
describes the QA procedures being implemented by their organization. If there is a dispute about
the audit findings, it shall be resolved in accordance with the dispute resolution procedures
specified in Section 1.6 of the Region III QMP. Upon completion of its review, the Division or
Program Office shall provide the audit 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 procedures
shall be used to achieve consensus on the content of the final audit findings report. The audit
team shall submit the final audit 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. The Corrective Action Plan must identify the corrective action,
responsible official(s), and the projected completion date for each finding requiring corrective
action. This Corrective Action Plan shall be submitted to the QSA team within 30 days. The
QSA team shall review and approve the Division or Program Office's Corrective Action Plan.
The Division or Program Office's QA Coordinator and the RQAM shall periodically review the
status of approved Division or Program Office Corrective Action Plans. 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 QSA shall also be included.
9.1.2 External Quality System Assessments
External assessments are conducted by the OEI Quality Staff, Office of Inspector General
auditors, 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 consists of members of the OEI Quality
Staff and at least one person from another Region. The scope of this audit 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, the Region's Findings Report is finalized. If
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 audit file, which is maintained
by the RQAM, or designee. Region III managers are responsible for ensuring compliance with
the approved corrective actions. Bi-annually, the RQC will provide Senior Managers with
information about the Region's progress on implementation of the Corrective Action Plan.
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The QAARWP will summarize the findings of each QSA conducted during the previous
fiscal year. A summary of corrective actions initiated as a result of the OEI QSA shall also be
included.
9.2 TECHNICAL SYSTEMS AUDIT (TSA)
The goal of the TSA is to determine whether environmental data collection activities and
related results comply with the project's QAPP and other planning documents. TSAs may also
be used as an investigative tool when problems are suspected. 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 TSA is documented in the QAPP. The Project Manager or Project Officer is
responsible for ensuring the specified TSA is accomplished. The individuals conducting the
technical system audit should be knowledgeable of the procedures being audited.
The procedures being used to conduct TSAs of program activities (i.e., State laboratories,
PM 2.5, NPDES facilities, PRP laboratories, etc.) can be found in each Division or Program
Office QMP. These QMPs shall also include the title(s) of the individual(s) responsible for
ensuring that these TSAs are conducted. Information about TSAs being conducted by State
Agencies shall be included in their approved QMP. The RQAM, designee shall ensure that a
description of TSAs is included in all QMPs.
9.3 LABORATORY ASSESSMENTS
The EAID/ASQAB Technical Director in conjunction with members of the ASQAB
Analytical Team, Client Services Team and Quality Assurance Team conduct assessments of
laboratories that support the National Pollution Discharge Elimination System (NPDES) program
and the Safe Drinking Water Act (SDWA) program. EAID/ASQAB also conducts assessments
of several laboratories being used by Superfund Potentially Responsible Parties (PRP). The
EAID/ASQAB Client Services Team conducts assessments of laboratories in Region III that
participate in the Contract Laboratory Program and the Delivery of Analytical Services
procurement process. EAID/ASQAB also performs inspections under the National
Environmental Laboratory Accreditation Program (NELAP) for the review of Accrediting
Authorities(AA)
9.3.1 National Pollution Discharge Elimination System (NPDES)
EAID/ASQAB conducts laboratory assessments of NPDES permittee laboratories and
commercial laboratories analyzing compliance samples. Inspections are routinely performed in
partnership with the State Authority and may be announced or unannounced to the facility. The
goal of these assessments are to improve Discharge Monitoring Reports Quality Assurance
(DMRQA) performance; to provide technical assistance to States that have limited expertise in
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certain analytical methodology; to improve analytical QA/QC procedures; and to improve
documentation procedures.
During the DMRQA laboratory assessments, a review of analytical procedures; sampling
procedures; equipment; instrumentation; record keeping; documentation; analytical data and
Proficiency Testing (PT) sample results are conducted. A Data Audit Inspection (DAIs) is also
conducted. This audit is conducted by recalculating the results from unprocessed instrument
results and comparing them to the results reported on the Discharge Monitoring Reports (DMRs).
If routine problems are found in the Proficiency Testing (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 EAID/ASQAB 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", Fall 1994, EPA-903-R-94-043 (currently in
revision).
93.2 Safe Drinking Water Act (SDWA)
ASQAB performs laboratory inspections of Region III State Laboratories using
procedures specified by the Agency's Laboratory Certification Manual (LCM), EPA 815-B-97-
001( March 1997) and by SOP, R3-QA801.0: On-site Laboratory Assessments in the Drinking
Water Laboratory Certification Program (September 2001). The procedures for the Data Audit
Inspections are similar to those described in Section 9.3.1. On-site assessments are conducted
every three years and corrective actions are tracked and official certification update reports are
issued. Recommendations for changes in certification status are based upon corrective actions.
The EAID/ASQAB Technical Director is responsible for tracking corrective actions: ASQAB
also performs reviews of the Region III State SDWA Laboratory Certification Programs as per
the Laboratory Certification Manual. Ever three years, the assessments and program are
reviewed by the Office of Ground Water and Drinking Water through yearly questionnaires and
on-site inspection.
933 Superfund Program: Laboratories used by Potentially Responsible Parties
(PRP)
ASQAB conducts inspections of laboratories being used by Region III Superfund PRP.
The Region HI Hazardous Site and Cleanup Division (HSCD) selects the PRP laboratories that
will be inspected. These laboratory inspections are conducted in accordance with the procedures
found in the Standard Operating Procedure for On-site Inspection of Superfund PRP Monitoring
Procedures (December 2000). The procedures for the Data Audit Inspections are similar to those
described in Section 9.3.1. 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 EAID/ASQAB Quality Assurance Team. The
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EAID/ASQAB Technical Director is responsible for tracking the corrective actions for PRP
laboratories.
9.3.4 Contract Laboratory Program (CLP)Routine Analytical Services (RAS):
The EAID/ASQAB Client Services Team 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 EPA Office of Solid Waste and Emergency
Response (OS WER), Office of Emergency and Remedial Response (OERR), Analytical
Operations/ Data Quality Center (AO/DQC) conducts a contract compliance screening (CCS) of
all CLP analytical data packages. The primary goal of the CCS is to ensure that the laboratory
adheres to the applicable CLP contract documentation requirements The EAID/ASQAB Client
Services Team in conjunction with the Region III Environmental Services Assistance Team
(ESAT) also conducts evidentiary audits of CLP laboratory analytical deliverable packages.
These evidentiary audits evaluate the documentation for chain-of-custody and sample handling
procedures.
The results of the on-site audit, the contract compliance screening, Quarterly blind
Proficiency Testing samples, data validation and monthly laboratory visits are used to assess a
CLP laboratory's performance. Corrective actions from these laboratory assessments 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.
9.3.5 Delivery of Analytical Services (DAS):
For the analysis of samples for non-CLP methods, the Region contracts laboratories via
the DAS procurement process. Whenever possible, the Region will use CLP laboratories for
DAS 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 sample receipt, all DAS laboratories must provide a
statement of qualifications. At a minimum, this statement of qualifications shall contain 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 (IDC) for the non-routine method. The EAID/ASQAB Client
Services Team evaluates each of the proposed laboratory's statement of qualifications and IDC
results (if applicable) to assess a laboratory's capability to conduct analyses for the DAS
program.
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The EAID/ASQAB Client Services Team also conducts on-site audits of DAS
laboratories located in the Region. The procedures found in the applicable CLP Statement of
Work may be used to conduct these on-site audits. If applicable, the CLP on-site audit checklist
is used for specific analytical fractions (i.e., volatiles, semivolatiles, pesticides, metals, cyanide,
etc.). The EAID/ASQAB Client Services Team in conjunction with the Region III ESAT also
conducts a contract compliance screening and evidentiary audits of DAS laboratory analytical
deliverable packages. The results of the on-site audit, the compliance screening and data
validation are used to assess a CLP laboratory's performance. Corrective actions from these
laboratory assessments are monitored by the Region III DAS Project Officer. If significant
contract non-conformance is found, the Region III DAS Project Officer may reject the data
and/or initiate a reduced payment.
9.3.6 National Environmental Laboratory Accreditation Conference (NELAC)
EAID/ASQAB performs inspections under the National Environmental Laboratory
Accreditation Program (NELAP) for the review of Accrediting Authorities (AA). The
procedures for conducting these inspections are documented in the National Environmental
Laboratory Accreditation Conference (NELAC) Chapter 6 (Accrediting Authority). The results
of the inspections are documented in a 23 page checklist. Findings are resolved with the AAs
and the final reports are sent to the NELAP Director for final review and approval. The
program's procedures, assessments and accreditation are reviewed yearly by the AA Review
Board (described in Chapter 6 of the NELAC standards).
EAID/ASQAB has completed an inspection of the program being conducted by the
PADEP. In addition, EAID/ASQAB has completed a preliminary review of the program planned
for the Virginia Division of Consolidated Laboratory Services. EAID/ASQAB will also be
participating in NELAC accreditations of Region III State Laboratories and will serve on
assessment teams to accredit EPA Regional Laboratories.
The Quality System being implemented by the EPA Program for the Accreditation of
Laboratories (EPAL) is documented in a Quality Manual and detailed SOPs (rev., 2002). This
documentation has been reviewed by representatives from Florida, New York and Texas and
found compliant with Chapter 6. NELAP conducts a detailed program review (Management
System Review) of EPAL every 2 years. Every three years, NELAP will also conduct a TSA of
EAID/ASQAB. This TSA will include interviewing EAID/ASQAB assessors and reviewing
files of on-site inspections.
9.4 DATA QUALITY ASSESSMENTS
The goal of the DQA is to determine if data obtained from environmental data operations
are of the right type, quality, and quantity to support its intended use. The scope of the DQA
should be commensurate with the project objectives and intended use of the data. The
procedures to be followed for data quality assessments shall be included in the project's QAPP or
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SAP. The title(s) of the individual(s) responsible for the DQA process should 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.
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CHAPTER 10: QUALITY IMPROVEMENT
The QA procedures described in the previous nine Chapters 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 include quality assurance as a
critical component of all the work functions within our programs.
10.1 APPROACH TO IMPROVEMENT
At the beginning of each fiscal year, the RQC shall review the information included in the
previous year's QAAWRP, Quality System Status Report and QSA reports. This information
will be used to establish the Region's QA priorities for the upcoming fiscal year. These priorities
will be documented in the upcoming year's Quality System Status Report. A more detailed
description of the Region's Quality System Status Report can be found in Section 2.5.
Throughout the year, the report shall be updated by the RQAM, or designee when QA activities
are completed. The Quality System Status Report shall also be attached to the agenda and
minutes of all RQC meetings. This process helps ensure that all Division or Program Offices are
routinely made aware of the Region's progress in implementing its QA priorities. In addition,
the RQC schedules quarterly QA briefings with Senior Managers to discuss the status of the
Region's Quality System.
All Regional personnel are encouraged to raise issues that impact the quality of data and
information being generated or used by the Region. These issues should be raised to the
designated Division or Program Office QA Coordinator. One issue that has been identified is the
need to develop a formal process to conduct QSA of State programs. 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.
10.2 IMPROVEMENT LEADERS
10.2.1 Program Level
All individuals who are active participants in the Region's Quality System have the
opportunity to serve as an improvement leader. As noted in the previous section, all Regional
personnel are encouraged to offer suggestions about ways to improve the Region's Quality
System. The members of the Senior Management Representative to the RQC, the RQAM, the
RQAO and each of the members of the RQC serve as the Region's quality champions. These
individuals promote the use of Quality System tools within their organization. A list of these
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RIII 5360.1 A CHG 2
June 4,2003
tools can be found in Chapter 2.0.
10.2.2 Project Level
At the project level, the information obtained from technical system audits, data quality
assessments, conference calls and project meetings will be used to determine if there are
opportunities for quality improvements. If it is determined that quality improvements should be
implemented to ensure that the quality of data being generated is of adequate quality for its
intended use, the proposed changes to the project's existing sampling and analysis procedures
must be submitted to the Project Manager/Project Officer for review and approval. These
proposed QAPP changes must be reviewed and approved in accordance with the procedures
specified in each Division or Program Office approved QMP. The approved changes must be
included in the project files. In addition, the final project report will document the rationale for
the proposed changes and the results of the quality improvements that were implemented. The
Project Manager/Project Officer shall ensure that all project personnel obtain copies of the
project's revised sampling, analytical or data quality procedures. Older versions of the revised
procedures shall be removed from all work areas.
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Figure 1: Organizational Chart: EPA Region III
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RIII 5360.1 A CHG 2
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Figure 2: QA Chart
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APPENDIX A
STANDARD OPERATING PROCEDURES
Subject
Revision
Date
Chesapeake Bav Program Office
Managing Non-Point Source Data
0
June 14,2002
Blind Audit Program
0
June 21, 2002
Managing Point Source Data
0
June 21, 2002.
Assumptions and Procedures for Calculating Water
Quality Status and Trends In Tidal Waters of the
Chesapeake Bay and its Tributaries
January 2002
Environmental Services Division1
Freshwater Bioloev Laboratory
Macroinvertebrate Sample Receiving and Handling
2
July 2001
Macroinvertebrate Sample Subsampling and Sorting
2
July 2001
Identification of Macroinvertebrates
2
July 2001
Bioassessments Information & Data Management
Systems
2
July 2001
Bioassessments Document Handling
2
July 2001
Handling, Storage and Disposal of Toxicity Samples
0
July 2001
Data Review/Reporting/Retention Process for
Toxicity Testing
0
July 2001
Analysis of Total Residual Chlorine for Toxicity
Testing
0
July 2001
Amber Science Digital Conductivity Meter - Model
604
0
July 2001
Standard Operating Procedure (SOP) for the YSI
0
July 2001
Hanna pH Meter - Model 9023
0
July 2001
Cole Palmer Conductivity Meter - Model 01481-61
0
July 2001
Fathead Minnow, Pimephales Promelas Larval
Survival & Growth Test,
0
July 2001
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Dissolved Oxygen Meter - Model 50B
0
July 2001
Cladoceran, Ceriodaphnia Dubia Survival &
Reproduction Test
0
July 2001
Acute Toxicity Test
0
July 2001
'A list of Standard Operating Procedures used by the Environmental Services Division,
Analytical Services and Quality Assurance Branch Laboratory (ASQAB) may be obtained from
the ASQAB Director.
Subject
Revision
Date
Office of Enforcement. Comoliance and Environmental Justice
Field Operations
0
April 1982
RCRA Sampling Procedures for Drums/containers
1
August 1,2001
RCRA Sampling Procedures for Tanks
1
August 1, 2001
RCRA Sampling Procedures for Soil
1
August 1,2001
RCRA Groundwater Sampling Procedures
1
August 1,2001
RCRA Sampling Procedures for Waste Piles2
PCB Wipe Sampling Procedures
July, 1999
Sampling of Residential Drinking Water
Residential Well Sampling
QA/QC Guidance and Sop for NPDES Sampling
Summer 1999
Lamotte - Del 100 Chlorine Analyzer
Ysi Model 58 DO Meter
Beckman Model 11 Ph Meter
GPS Pro Instructions
August 1999
Niton X1309 Lead Detector
Hydrolab Calibration Procedure
2 Cannot Be Finalized at Present Time. Awaiting promulgation of Revised SW846
manual.
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APPENDIX B
REFERENCES
Quality System Documents
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.
EPA Quality Manual for Environmental Programs; EPA Order 5360.1 Al, 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, U.S. Government Printing Office; Washington, DC,
2001.
EPA Requirements for QA Project Plans (R-5); EP A/240/B-01/003; U.S. Environmental
Protection Agency, U.S. Government Printing Office; Washington, DC, 2001.
Guidance for the Data Quality Objectives Process (G-4); EPA/600/R-96/055; U.S.
Environmental Protection Agency, U.S. Government Printing Office; Washington, DC,
2000.
Guidance on Quality Assurance Project Plans (G-5); EPA/600/R-02/009; U.S. Environmental
Protection Agency, U.S. -Government Printing Office; Washington, DC, 2002.
Guidance for Preparing Operating Procedures (G-6); EPA/240/B-01/004; U.S. Environmental
Protection Agency, U.S. Government Printing Office; Washington, DC, 2001.
Guidance on Technical Audits and Related Assessments (G-7); EPA/600/R-99/080; U.S.
Environmental Protection Agency, U.S. Government Printing Office; Washington, DC,
2000.
Guidance on Environmental Verification and Validation fG:-5J;EPA/240/R-02/004; U.S.
Environmental Protection Agency, U.S. Government Printing Office; Washington, DC,
2002.
Guidance for Data Assessment: Practical Methods for Data (G-9); EPA/600/R-96/084; U.S.
Environmental Protection Agency, U.S. Government Printing Office; Washington, DC,
2000.
Guidance for Developing Training Program for Quality Systems (G-10), EPA/240/B-00/004;
U.S. Environmental Protection Agency, U.S. Government Printing Office; Washington,
DC, 2000.
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Policy and Program Specifications for the Mandatory Agency-wide Quality System-, EPA Order
5360.1 A2, U.S. Environmental Protection Agency; Washington, DC, 2000.
Guidance for Use of Higher-Level Contract Quality Requirements in Acquisitions; Procurement
Policy Notice; U.S. Environmental Protection Agency, Office of Environmental
Information; Washington, DC, 2001.
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.html1
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 for the Electronic Transmission of Laboratory Measurement Results', EPA
Order 2180.2. 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/labmeas/index.htmD
Facility Identification Data Standard; EPA Order 2180.3; U.S. Environmental Protection
Agency, Office of Environmental Information, Office of Technology Operations and
Planning, Information Technology Policy and Planning Division; Washington, DC,
1990. (Web Site: http://www.epa.gov/irmpoli8/facilid/index.htmD
Information Resources Policy Manual; EPA Directive 2100; U.S. Environmental Protection
Agency, Office of Environmental Information, Office of Technology Operations and
Planning, Information Technology Policy and Planning Division; Washington, DC,
1991. (Web Site: http://www.epa.gov/irmpoli8/polman/index.htmD
Minimum Set of Data Elements for Ground Water Quality, EPA Order 74500.IA,
U.S. Environmental Protection Agency, Office of Environmental Information, Office of
Technology Operations and Planning, Information Technology Policy and Planning
Division; Washington, DC 1992. (Web Site:
http://www.epa.gov/irmpoli8/gwstnd/index.htmD
One Stop Reporting; U.S. Environmental Protection Agency, Office of Environmental
Information; Washington,DC, 1998. (WebSite:
http://www.epa.gov/OEI/onestop/blocks/blocks.htm')
Requiring the Agency to Purchase Energy Efficient Computer Equipment, Executive Order
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12845; Washington, DC, 1993. (Web Site:
http ://hvdra.gsa. gov/pbs/pt/call-in/eo 12845 .htm)
Site Location Identification Policy and Responsibilities', Region III Order 5361.5; U.S.
Environmental Protection Agency, Region HI; Philadelphia, PA, 1988.
Program Documents
Chesapeake Bay Program Mainstem Coordinated Split Sample Program Report 1994-1998;
EPA-903-R-99-024; U.S. Environmental Protection Agency, Region III, Chesapeake
Bay Program Office; Annapolis, MD 1999.
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.
NPDES Compliance Inspection Manual, EPA 300-B-94-014; U.S. Environmental Protection
Agency, Office of Wastewater Management; Washington, DC, 1994
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.
Procedures for implementing QA requirements in extramural agreements', U.S. Environmental
Protection Agency, Chesapeake Bay Program Office; Annapolis, MD, 2001.
RCRA Inspection Manual',,EPA 530R94007; U.S. Environmental Protection Agency, Office of
Solid Waste and Emergency Response; Washington, DC, 1993.
Uniform Federal Policy for Implementing Environmental Quality Systems (Interim Final);
Intergovernmental Data Quality Task Force; 2000.
Uniform Federal Policy for Implementing Environmental Quality Systems (Draft);
Intergovernmental Data Quality Task Force; 2001.
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
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Air Protection Division Quality Management Plan', U.S. Environmental Protection Agency; Air
Protection Division; Philadelphia, PA, 2001.
Chesapeake Bay Program Office Quality Management Plan; U.S. Environmental Protection
Agency, Chesapeake Bay Program Office; Annapolis, MD, 2001.
Environmental Services Division Quality Management Plan (draft)-, U.S. Environmental
Protection Agency; Environmental Services Division; Philadelphia, PA, 2002.
Freshwater Biology Laboratory Quality Manual, U.S. Environmental Protection Agency;
Environmental Services Division; Wheeling, WV, 2001.
Hazardous Site Cleanup Division Quality Management Plan (draft); U.S. Environmental
Protection Agency; Hazardous Site Cleanup Division; Philadelphia, PA, 2001.
Office of Analytical Services and Quality Assurance (OASQA) Laboratory QA Manual (revision
2)\ U.S. Environmental Protection Agency; Environmental Services Division, Office of
Analytical Services and Quality Assurance; Philadelphia, PA, 2001.
Quality Management Plan for Ocean dumping Program; U.S. Environmental Protection
Agency; Environmental Services Division; Philadelphia, PA, 2001.
Waste and Chemicals Management Division Quality Management Plan; U.S. Environmental
Protection Agency; Waste and Chemicals Management Division; Philadelphia, PA,
2000.
Water Protection Division Quality Management Plan; U.S. Environmental Protection Agency;
Water Protection Division; Philadelphia, PA, 2001.
Records Management
Cartographic, Aerial Photographic, Architectural, and Engineering Records, General Records
Schedule 17; National Archives and Records Administration (NARA); Washington, DC,
1988. (Web Site - http://ardor.nara.gov/grs/grs 17.htmD
Records Management Manual; EPA Directive 2160; U.S. Environmental Protection Agency, O
Office of Environmental Information, Office of Technology Operations and Planning,
Information Technology Policy and Planning Division; Washington, DC, 1984. (Web
Site: http://www.epa.gOv/records/policv/2160/index.htrrA
Sampling and Analysis
General Requirements for the Competence of Testing and Calibration Laboratories; ISO/IEC
17025; International Organization for Standardization and the International
Electrotechnical Commission; 1999.
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Manual for the Certification of Laboratories Analyzing Drinking Water; EPA 815-B-97-001;
U.S. Environmental Protection Agency, Office of Water; Washington, DC, 1997.
National Environmental Laboratory Accreditation Conference (NELAC) Standards; National
Environmental Laboratory Accreditation Conference (NELAC); 2000.
National Environmental Methods Index; National Water Quality Monitoring Council;
Washington, DC, 2002. (Web Site -
http://wi.water.usgs.gov/pmethods/NEMI/NEMI.htmn
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', U.S. Environmental Protection Agency, Region III, Environmental Services
Division, Office of Analytical Services and Quality Assurance; Fort Meade, MD, 2002.
Split Sampling Study for the Maryland and Virginia Mesozooplankton Monitoring Programs',
ICPRB Report 00-3; Interstate Commission on the Potomac River Basin; 2000.
Standard Guide for General Criteria Used for Evaluating Laboratory Competence; E 548-94;
American Society for Testing and Materials; West Conshohocken, PA, 1995.
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APPENDIX C
GLOSSARY
Acquired data - data or information used for project implementation or decision making which
may meet some of the following criteria: is compiled from other sources; was originally
collected for some other purpose; or is obtained from non-measurement sources such as
computer databases, programs, literature files, historical data bases, or any other sources.
Assessment - the evaluation process used to measure the performance or effectiveness of a
system and its elements. As used here, assessment is an all-inclusive term used to denote any of
the following: audit, performance evaluation, management systems review, peer review,
inspection, or surveillance.
Audit (quality) - a systematic and independent examination to determine whether quality
activities and related results comply with planned arrangements and whether these arrangements
are implemented effectively and are suitable to achieve objectives.
Data quality assessment (DQA) - a statistical and scientific evaluation of the data set to
determine the validity and performance of the data collection design and statistical test, and to
determine the adequacy of the data set for its intended use.
Document - any written or pictorial information describing, defining,-specifying, reporting, or
certifying activities, requirements, procedures or results pertaining to environmental operations.
Examples include: QAPP, QMP, technical manuals, manuals, SOPs, etc.
Environmental data - any measurements or information that describe environmental processes,
location, or conditions; ecological or health effects and consequences; or the performance of
environmental technology. For EPA, environmental data include information collected directly
from measurements, produced from models, and/or compiled from other sources such as
databases, the literature, or any other sources.
Environmental data operations - work performed to obtain, use, or report information
pertaining to environmental processes and conditions.
Environmental programs - work or activities involving the environment, including but not
limited to: characterization of environmental processes and conditions; environmental
monitoring; environmental research and development; the design, construction, and operation of
environmental technologies; and laboratory operations on environmental samples.
Environmental technology - an all-inclusive term used to describe pollution control devices
and systems, waste treatment processes and storage facilities, and site remediation technologies
and their components that may be utilized to remove pollutants or contaminants from or prevent
them from entering the environment Examples include wet scrubbers (air), soil washing (soil),
granulated activated carbon unit (water), and filtration (air, water). Usually, this term will apply
to hardware-based systems; however, it will also apply to methods or techniques used for
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RIII 5360.1 A CHG 2
June 4, 2003
pollution prevention, pollutant reduction, or containment of contamination to prevent further
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RIII 5360.1 A CHG 2
June 4, 2003
movement of the contaminants, such as capping, solidification or vitrification, and biological
treatment.
Generic Quality Assurance Project Plan - a formal document for multiple projects or sites
with the same objectives and environmental decision(s) describing in comprehensive detail the
necessary QA, QC, and other technical activities that must be implemented to ensure that the
results of the work performed will satisfy the stated performance criteria.
Graded approach - the process of basing the level of application of managerial controls
applied to an item or work according to the intended use of the results and the degree of
confidence needed in the quality of the results.
Independent evaluation - an evaluation performed by a qualified individual, group, or
organization that is not a part of the organization directly performing and accountable for the
work being assessed.
Management - those individuals directly responsible and accountable for planning,
implementing, and assessing work.
Management system - a structured, non-technical system describing the policies, objectives,
principles, organizational authority, responsibilities, accountability, and implementation plan of
an organization for conducting work and producing items and services.
Organization - an agency, entity, company, corporation, firm, enterprise, or institution, or part
thereof, whether incorporated or not, public or private, that has its own functions and
administration.
Peer review - a documented critical review of work by qualified individuals (or organizations)
who are independent of those who performed the work, but are collectively equivalent in
technical expertise. A peer review is conducted to ensure that activities are technically adequate,
competently performed, properly documented, and satisfy established technical and quality
requirements. The peer review is an in-depth evaluation of the assumptions, calculations,
extrapolations, alternate interpretations, methodology, acceptance criteria, and conclusions
pertaining to specific work and of the documentation that supports them.
Proficiency Testing Sample - a type of audit in which the quantitative data generated in a
measurement system are obtained independently and compared with routinely obtained data to
evaluate the proficiency of an analyst or laboratory.
Process - a set of interrelated resources and activities which transforms inputs into outputs.
Examples of processes include analysis, design, data collection, operation, fabrication, and
calculation.
Quality - the totality of features and characteristics of a product or service that bear on its ability
to meet the stated or implied needs and expectations of the user.
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Rffl 5360.1 A CHG 2
June 4, 2003
Quality assurance (QA) - an integrated system of management activities involving planning,
implementation, documentation, evaluation, reporting, and quality improvement to ensure that a
process, item, or service is of the type and quality needed and expected by the client.
Quality Assurance Project Plan (QAPP)- a formal document describing in comprehensive
detail the necessary QA, QC, and other technical activities that must be implemented to ensure
that the results of the work performed will satisfy the stated performance criteria.
Quality control (QC) - the overall system of technical activities that measures the attributes
and performance of a process, item, or service against defined standards to verify that they meet
the stated requirements established by the customer; operational techniques and activities that
are used to fulfill requirements for quality.
Quality improvement - a management program for improving the quality of operations. Such
management programs generally entail a formal mechanism for encouraging worker
recommendations with timely management evaluation and feedback or implementation.
Quality management - that aspect of the overall management system of the organization that
determines and implements the quality policy. Quality management includes strategic planning,
allocation of resources, and other systematic activities (e.g., planning, implementation,
documentation, and evaluation) pertaining to the Quality System.
Quality Management Plan (QMP) - a document that describes the Quality System in terms of
the organizational structure, functional responsibilities of management and staff, lines of
authority, and required interfaces for those planning, implementing, and assessing all activities
conducted.
Quality System - a structured and documented management system describing the policies,
objectives, principles, organizational authority, responsibilities, accountability, and
implementation plan of an organization for ensuring quality in its work processes, products
(items), and services. The Quality System provides the framework for planning, implementing,
documenting, and assessing work performed by the organization.
Record - a completed document that provides objective evidence of an item or process. Records
may include photographs, drawings, magnetic tape, and other data recording media.
Senior Manager - an individual that serves as a Division Director or Program Office Director.
Specification - a document stating requirements and which refers to or includes drawings or
other relevant documents. Specifications should indicate the means and the criteria for
determining conformance.
Standard Operating Procedure (SOP) - a written document that details the method for an
operation, analysis, or action with thoroughly prescribed techniques and steps, and that is
officially approved as the method for performing certain routine or repetitive tasks.
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RID 5360.1 A CHG 2
June 4, 2003
Surveillance (quality) - continual or frequent monitoring and verification of the status of an
entity and the analysis of records to ensure that specified requirements are being fulfilled.
Technical review - a documented critical review of work that has been performed within the
state of the art. The review is accomplished by one or more qualified reviewers who are
independent of those who performed the work, but are collectively equivalent in technical
expertise to those who performed the original work. The review is an in-depth analysis and
evaluation of documents, activities, material, data, or items that require technical verification or.
validation for applicability, correctness, adequacy, completeness, and assurance that established
requirements are satisfied.
Technical System Audits (TSA) - a thorough, systematic, on-site, qualitative audit of facilities,
equipment, personnel, training, procedures, record keeping, data validation, data management,
and reporting aspects of a system.
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Figure 2
OA FUNCTIONS
Regional Quality Council
REGIONAL ADMINISTRATOR
DEPUTY REGIONAL ADMINISTRATOR
REGIONAL QUALITY COUNCIL MEMBERS
QA COORDINATORS
SENIOR MANAGEMENT REPRESENTATIVE
REGIONAL QA MANAGER
Environmental Services Division
CLIENTS
TEA,
ANALYTICAL
TEAM
AQUATIC
BIOLOGY
TEAM
REGIOHAL QA
OFFICER
DIVISIOH DIRECTOR
INNOVATION
BRANCH
KtUIOHAL QA MANAVtK
OFFICE OF ENVIRONMENTAL
PROGRAMS
ENVIRONMENTAL INFORMATION
ANALYSIS BRANCH
ANALYTICAL SERVICES AND
QUALITY ASSURANCE BRANCH
Ybe RqgbfljIOA Mjnagcr(RQAM) h bested in the Dr*fcbnS bmodbtc Office. The RQ&M h independent of direct envifonmcMdlQcnctalbn,
rปฎdcl dcvctopincnl, of environmental tocbnobgydcvebpfneirt. On inirai lebttotolheRegbn'iqajIrtytyttaA.lbe RQ^U reports to the
Senior ULxn^aoracat Representative ef the RqobnalQiijfrlyCooncn.
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PROPOSED REGION III ORGANIZATION CHART
OfTKE OF ENFORCEMENT,
COMPLIANCE, AND
BftflROHMBITAL JUSTICE
HAZARDOUS SITE
CLEANUP (HVISIOM
WASTE AND CHEMICALS
MANAGEMENT DIVISION
OFFICE OF
COMMUWCATIOHS AND
GOVERNMENT RELATIONS
WATS* PROTECTION
DJVtStON
OFFICE OF REGKMAL
COUHSB.
ENVStONMENTAL
ASSESSMSIT AND
INNOVATION DIVISION
AIR PROTECTION DtVtSKN
CHESAPEAKE DAY PROGRAM
OFRCE
OFRCE OF THE ASSISTANT
REGIONAL ADMINSTRATOR
FOR POLICY AND MANAGEMENT
DBVTV REGIONAL ADWWSTRATOR
REGIONAL ADMINISTRATOR
CHIEF OF STAFF
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