QUALITY MANAGEMENT PLAN
for
REGION 7
March 2017
Region 7
United States Environmental Protection Agency
11201 Renner Boulevard
Lenexa, KS 66219
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REGION 7 QUALITY ASSURANCE MANAGEMENT PLAN APPROVALS
Rebecca Weber
Director, Air and Waste Management Division
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Ceoilia Tapia
Director; Environmental Sciences and Technology Division
Mary Petersen
Director, Superfand Division
Jeff Robichaud
Acting Director, Water, Wetlands, and Pesticides Dmsion
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Patrick Bustos
Director, Office of Tribal Affairs
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Leslie Humphrey 0
Acting, Office of Regional Counsel
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Curtis Carey 1
Director, Office of Public Affairs
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Director, Enforcement Coordination Office
FcnjcMH A KrcLtfel
Assistant Regional Administrator ve^m
Office of Policy and Management
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iVIc I'ecMn 7 xOl* tlMP
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REGION -> Ql.Al I'l V ASSURANCE MANAGEMKNT PLAN APPROVALS
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Diane Harris
Regional Qual:l> Assuutncc Manager
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Edward H. Chu
Acf«n« Regional Vdmniistt^loi
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Vinek Iltjlluimin
Acting Director, Enterprise Quality Management Division
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TABLE OF CONTENTS
1. MANAGEMENT AND ORGANIZATION 10
1.1. Definition of Environmental Data 10
1.2. Data Collection Activities Covered by the Quality Management Plan 10
1.3. Region 7 Programs Covered by the Quality Management Plan 10
1.4. Region 7 Mission 11
1.5. Quality Assurance Policy 11
1.6. Organization 12
1.6.1. Air and Waste Management Division (AWMD) 12
1.6.2. Environmental Services Division (ENST) 12
1.6.3. Superfund Division (SUPR) 13
1.6.4. Water, Wetlands, & Pesticides Division (WWPD) 13
1.6.5. Office of Regional Counsel (CNSL) 13
1.6.6. Office of Public Affairs (OP A) 13
1.6.7. Enforcement Coordination Office (ECO) 13
1.6.8. Office of Policy and Management (PLMG) 14
1.6.9. Office of Tribal and International Coordination (OTIC) 14
1.7. Key Region 7 Personnel 14
1.7.1. Regional Administrator 14
1.7.2. Environmental Services Division Director 165
1.7.3. Deputy Division Director, Environmental Services Division 165
1.7.4. Quality Assurance Personnel 16
1.7.4.1 Quality Assurance Team - Regional QA Manager 16
1.7.4.2 Quality Assurance Team - Permanently Assigned QA Staff 17
1.7.5. Division and Office Directors 18
1.7.6. Supervisors 18
1.7.7. Project Officers/Project Managers/Work Assignment Managers 18
1.8 Delegated Programs 19
1.9 Dispute Resolution 20
2. QUALITY SYSTEM COMPONENTS 21
2.1. Quality System Documents 21
2.1.1 .Internal Quality Management Plan 21
2.1.2.External Quality Management Plans 22
2.1.3.Quality Assurance Annual Report and Work Plan (QAARWP) 23
2.2. Management Evaluations 23
2.2.1.Quality System Audits (QSAs) and Management System Reviews (MSRs) 23
2.2.2.Program Reviews 23
2.2.3.Project Level Planning - Systematic Planning Process 23
2.2.4.Project-Level Documents - Quality Assurance Project Plans 23
2.2.5.Routine Procedures Documents 24
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2.2.5.1.Standard Operating Procedures 24
2.2.5.2.Analytical Methods Manual 24
2.2.6.Project-Level Evaluations 24
2.2.6.1.Data Quality Assessments 24
2.2.6.2.Technical Systems Audits 24
2.2.6.3.Other Technical Audits 25
2.2.6.4.Performance Evaluations 25
2.2.7.Quality System Personnel Standards - Quality Assurance Training 25
2.2.8.Information Quality Guidelines 25
2.2.8.1.Implementation Policy and Procedures 25
2.2.8.2.Requests for Correction 26
3. QUALIFICATIONS AM) TRAINING 27
3.1. Region 7's QA Training Program 27
3.2. Courses 27
3.2.1.Logistic s 28
3.2.2.Documentation of Training 28
3.2.3.Training Requirements 28
3.2.3.1. Management 29
3.2.3.2. Supervisors 29
3.2.3.3.Project Managers, Lab and Field Personnel 29
3.2.3.4.Permanently assigned QA Staff 29
3.2.3.5.RQA M 30
3.2.4.Recertificatio n 30
3.2.5.Assurance for Grants and Contracts 30
4. PROCUREMENT AND FINANCIAL ASSISTANCE 31
4.1. Procurement - Contracts 31
4.2. Financial Assistance 32
4.2.1.Grants and Cooperative Agreements 32
4.2.2.Interagency Agreements 33
4.2.3.FEM Competency Policy 34
4.2.3.1. States 34
4.2.3.2.Tribes and other grantees 35
4.2.3.3.Region 7 QA Office and Project Officer Responsibilities 36
5. DOCUMENT AND RECORDS MANAGEMENT 37
6. COMPUTER HARDWARE AM) SOFTWARE 38
6.1. Region 7 Information Management System 38
6.2. Hardware and Software Requirements 39
6.3. Data Standards 39
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7. QUALITY PLANNING 40
7.1. Annual Planning 40
7.2. Project-level Planning 40
7.2.1. Systematic Planning Process 40
7.2.2.Quality Assurance Project Plans 41
7.2.3.Quality Assurance Project Plan Preparation, Review, and Approval 41
7.2.4.Quality Assurance Project Plan Review and Approval Authorization 42
7.2.5.Generic Quality Assurance Project Plans 43
7.2.6.Regulated Facilities 44
7.2.7.Quality Assurance Project Plan Implementation 44
7.2.8.Quality Assurance Project Plan Revision 44
7.3. Acquired Data 44
8. IMPLEMENTATION OI WORK PROCESS 46
8.1. Program Implementation 46
8.2. Project Implementation 46
8.3. Standard Operating Procedures 46
8.3.1.Uses of SOPs 47
8.3.2.Implementation of SOPs 48
8.4. Analytical Methods 48
8.4.1.Use of Analytical Methods 48
8.4.2.Implementation of Analytical Methods 48
9. EVALUATION AND RESPONSE 49
9.1. Annual Review of the Quality System and Quality Management Plan 49
9.2. Audits 49
9.2.1.Quality System Audits (QSAs) and Management System Reviews (MSRs) 49
9.2.1.1 .QSAs by EQMD 49
9.2.1.2.MSRs by the Region 7 QA Team 50
9.2.2. Annual Program Reviews 51
9.2.3.Technical Systems Audits 51
9.2.4.Other Technical Audits 52
9.2.5.Response Actions 53
9.2.6.Data Quality Assessments 53
9.2.7.Performance Evaluations 53
9.2.8.Dispute Resolution 54
10. QUALITY IMPROVEMENT 55
10.1.Internal Region 7-Wide Reviews 55
10.2.SOP Reviews 55
10.3.Program Reviews 55
10.4.Project Reviews 56
10.5.Quality Improvement Responsibilities 56
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Attachment A:
Attachment B:
Attachment C:
Attachment D:
Attachment E:
Attachment F:
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LIST OF ATTACHMENTS
Region 7 Organization Chart with QA Lines of Authority and
Communication (1 page)
Quality Assurance Review for Extramural Projects Form (4 pages)
Standard Form 424 (1 page)
Programmatic Certification Authorization to Award Assistance
Agreement (1 page)
Quality Assurance Requirement Form (1 page)
Glossary (4 pages)
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LIST OF ACRONYMS
AWMD - Air and Waste Management Division
CAA - Clean Air Act
CNSL - Office of Regional Counsel
DQA - data quality assessment
ECO - Enforcement Coordination Office
EMMC - Environmental Monitoring Methods Council
ENST - Environmental Sciences and Technology Division
EPA - Environmental Protection Agency
EQMD - Enterprise Quality Management Division
MSR - management systems review
NARA - National Archives and Records Administration
OIRM - Office of Environmental Resources Information Management
OPA - Office of Public Affairs
OTA - Office of Tribal Affairs
PLMG - Office of Policy and Management
PPAs - Performance Partnership Agreements
QA - quality assurance
QAARWP - quality assurance annual report and work plan
QAFAP - Quality Assurance Field Activities Procedure (a.k.a., Field Operations Guidelines or
FOG)
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QAPP - quality assurance project plan
QC - quality control
QMP - quality management plan
QSA - quality systems audit
LTAB - Laboratory Technology and Analysis Branch
RCRA - Resource Conservation and Recovery Act
RQAM - Regional Quality Assurance Manager
SOP - standard operating procedure
SPP - systematic planning process
SUPR - Superfund Division
TEP - Technical Evaluation Panel
TSA - technical systems audit
WWPD - Water, Wetlands, and Pesticides Division
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1. MANAGEMENT AND ORGANIZATION
To implement Agency policy, EPA Laboratories, Program Offices, and Regional Offices are
required to prepare a QMP covering all intramural and extramural environmental programs
which generate and use environmental data. This QMP was prepared according to EPA
Requirements for Quality Management Plans. EPA QA/R-2, March 2001, reissued May 2006
and Chapter 3 of the EPA Quality Manual for Environmental Programs. CIO 2105-P-01, May 5,
2000 to document the quality assurance policies and management structure to be used in
implementing the Region 7 quality system.
1.1. Definition of Environmental Data
Environmental data are any measurements or information that describe environmental
processes, location, or conditions; ecological or health effects and consequences; or the
performance of environmental technology. For Region 7, environmental data include
information collected directly from measurements, produced from models, and compiled
from other sources such as databases or the literature.
Acquired data are data or information used for project implementation or decision making
which meet the following criteria: 1) are compiled from other sources; 2) were originally
collected for some other purpose; or 3) are obtained from non-measurement sources such as
computer databases, programs, literature files, and historical databases. The quality of
acquired data will directly impact the quality of the project results or environmental decision
to which they are applied and are subject to the Region 7 quality system requirements.
1.2. Data Collection Activities Covered by the Quality Management Plan
The QMP encompasses data directly generated by Region 7 programs, their contractors, or
grantees as well as data obtained for Region 7 programs from other sources. The QMP also
covers environmental data that Region 7 programs require States, tribal governments, and
grantees to collect.
In compliance with EPA OA Field Activities Procedure. CIO 2105-P-02.0, September 23,
2014, (QAFAP) Region 7 defines the scope of field activities to mean activities requiring the
collection of environmental observations, samples, or data in support of EPA programs,
Executive Orders, regulations, or environmental laws at a site or location. Region 7 further
defines environmental observations as observations about the environment that will be used
in decision making of environmental clean-up, compliance, enforcement, or monitoring
under any EPA regulatory program. In general, "environmental observations", as defined by
Region 7, are not likely to be made when Region 7 personnel conduct a facility or site visit
taken solely for the purpose of education (i.e. a site or facility tour). Section 1.6 of this QMP
identifies those Region 7 organizations subject to the QAFAP. See also the May 2017
Memorandum to File which provides additional detail and rationale regarding the Region 7
organizations subject to the QAFAP.
1.3. Region 7 Programs Covered by the Quality Management Plan
The Region 7 QMP is applicable to all Region 7 environmental programs. This includes field
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and laboratory data-gathering activities or investigations that involve the determination of
chemical, physical, locational measurements (in accordance with SOP 2341.01), or biological
characteristics related to the environment, the collection of observations and samples, as well
as investigations or studies that involve acquired data.
1.4. Region 7 Mission
Region 7's mission is to protect and enhance the quality of our air, water, and terrestrial
environment from pollution for the benefit of all by:
Preventing or minimizing the release of pollutants into our environment by ensuring
compliance with environmental laws and enforcing against those who violate these
laws;
Working in partnership with those federal, tribal, state, and local agencies with whom
we have shared responsibility for environmental protection;
Working with stakeholders to implement flexible voluntary approaches to solve
environmental problems;
Conducting environmental education and outreach to the public and regulated
community to enable them to prevent or reduce the generation of wastes and to
become better environmental stewards;
Making environmental quality information easily accessible to the public to enable
them to make choices about the level of environmental quality they expect; and
Ensuring all our nation's communities have equal protection from pollution.
1.5. Quality Assurance Policy
It is the policy of Region 7 that, within the constraints of available resources, quality
assurance activities be conducted to assure environmental data generated or used for its
programs will be of known and documented quality and adequate for their intended use. The
Region also promotes consistency in the management of field practices, including spatial
location collection, across Regional programs to reduce potential vulnerabilities. The Region
shall also support and implement a graded approach to the quality system which bases the
level of managerial controls applied to an item or work commensurate with the intended use
of the results and the degree of confidence needed for the results.
To ensure that this quality assurance policy is uniformly applied to Region 7 environmental
programs, the Region 7 Quality Assurance Manager (RQAM) is authorized to conduct
oversight of the Region 7 quality system. The authority covers environmental programs as a
result of:
Region 7 in-house environmental activities;
Contracts;
Interagency Agreements;
Grants;
Cooperative Agreements;
Partnerships with industry, state and local offices, tribes, and other EPA Offices; and
Enforcement agreements.
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1.6. Organization
Region 7 is organized into four Divisions: Air and Waste Management (AWMD);
Environmental Sciences and Technology (ENST); Superfund (SUPR); and Water Wetlands,
and Pesticides (WWPD); and five Offices: Office of Regional Counsel (CNSL); Office of
Public Affairs (OPA); Enforcement Coordination Office (ECO); Office of Tribal Affairs; and
Office of Policy and Management (PLMG). This QMP reflects the overall regional
organization found at Region 7 Organization Overview. See ENST Organization for the
ENST organizational structure including the position of the RQAM and QA Office. See
Attachment A for the QA lines of authority and communication for the RQAM and the QA
Office.
1.6.1. Air and Waste Management Division (AWMD)
AWMD, under the supervision of its Director, is responsible for the Clean Air Act
(CAA), Resource Conservation & Recovery (RCRA), Underground Storage Tank,
Leaking Underground Storage Tank, Risk Management Plan (CAA 112(R)), Emergency
Planning Community Right to Know Act, Spill Prevention Control Measures, TSCA
PCB programs, regulatory (other than Water) and industrial sector programs. The
Pollution Prevention program, also housed in AWMD, serves as an advocate for
Pollution Prevention approaches for all Region 7 programs and manages the Region 7
Pollution Prevention grants.
For AWMD, it has been determined that the following Branches are subject to the
QAFAP implementation requirements as defined in this QMP:
Waste Remediation and Permitting Branch (WRAP)
Waste Enforcement and Material Management Branch (WEMM)
Chemical and Oil Release Prevention Branch (CORP)
1.6.2. Environmental Sciences and Technology Division (ENST)
The Environmental Services, under the supervision of its Director, is responsible for
compliance inspections (air, RCRA, and water enforcement), environmental monitoring
(ambient air and water), the State Safe Drinking Water Act Laboratory certification
program, managing the Regional quality system, environmental evaluations,
Geographical Information Systems (GIS), providing laboratory services, developing an
expanded cross-media data integration and analysis program, and the National
Environmental Policy Act program.
For ENST, it has been determined that the following Branches are subject to the QAFAP
implementation requirements as defined in this QMP:
Environmental Field Compliance Branch (EFCB)
Environmental Data & Assessment Branch (EDAB)
Monitoring and Environmental Sampling Branch (MESB)
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1.6.3. Superfund Division (SUPR)
The Superfund Division, under the supervision of its Director, is responsible for
Superfund Emergency Response/Preparedness, Site Assessment, Remedial, Removal,
Federal Facilities, Brownfields and Oil spills programs.
For SUPR, it has been determined that the following Branches are subject to the QAFAP
implementation requirements as defined in this QMP:
Assessment Emergency Response & Removal Branch (AERR)
Lead Mining and Special Emphasis Branch (LMSE)
Site Remediation Branch (REMB)
1.6.4. Water, Wetlands, and Pesticides Division (WWPD)
The Water, Wetlands, & Pesticides Division, under the supervision of its Director, is
responsible for the Clean Water Act, Safe Drinking Water Act, Federal Insecticide,
Fungicide and Rodenticide Act, Endangered Species Act, lead-based paint, asbestos
AHERA, underground injection, and Sustainable Infrastructure.
For WWPD, it has been determined that the following Branches are subject to the
QAFAP implementation requirements as defined in this QMP:
Toxics & Pesticides Branch (TOPE)
Watershed Planning & Implementation Branch (WPIB)
Drinking Water Management Branch (DRWM)
Water Enforcement Branch (WENF)
1.6.5. Office of Regional Counsel (CNSL)
The Office of Regional Counsel, under the supervision of the Regional Counsel, serves as
a central legal office providing regional and national leadership in the environmental
arena, particularly in the area of enforcement.
1.6.6. Office of Public Affairs (OPA)
The Office of Public Affairs, under the supervision of its Director, is responsible for
environmental outreach and cultivating environmental values with Agency customers, the
states and tribal partners. Other major responsibilities include: media relations;
Intergovernmental relations; small business assistance; community involvement/outreach;
information sharing; Freedom of Information Act; product review; environmental
education; Web; and audio-visual. The Regional Community Based Environmental
Protection Program is also managed within OPA.
1.6.7. Enforcement Coordination Office (ECO)
The Office of Enforcement Coordination Office, under the supervision of its Director,
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provides cross-program enforcement coordination for the Region 7 divisions. The Office
is a focal point for review and dissemination of national enforcement guidance and
strategy and coordination of enforcement agreements with headquarters and states. ECO
manages compliance assistance and general coordination for federal facilities,
environmental justice coordination, and the Region 7 environmental justice grant
program.
1.6.8. Office of Policy and Management (PLMG)
The Office of Policy and Management, under the supervision of the Assistant Regional
Administrator, is responsible for policy, strategic planning, state relations including
capacity building, tribal and multimedia program coordination, budget formulation,
financial implementation, contracts, grants, cooperative agreements, facilities, human
resources, health and safety, information management, computer services, and other
administrative services (supplies, motor pool, mail, etc.).
1.6.9. Office of Tribal and International Coordination (OTIC)
The Office of Tribal Affairs, under the supervision of its Director, is responsible for
helping tribes strengthen their abilities to manage environmental programs in Indian
country and to ensure that tribes have a voice in decisions that affect their land, air, and
water. This includes the Regional Tribal Operations Committee (RTOC) which serves
critical functions in maintaining the government-to-government relationship between
EPA and the federally-recognized tribes located within Region 7. The RTOC assists with
advancing the protection and improving the conditions of tribal health and the
environment in Indian country. It serves as a liaison between the National Tribal
Operations Committee (NTOC), the tribal nations of Region 7, and EPA Region 7
personnel on national policy issues, and communicates environmental needs and
concerns of the RTOC to the NTOC. Region 7 serves nine federally recognized tribes
within the states of Kansas, Nebraska, and Iowa.
The international coordinator works with the Office of International and Tribal Affairs
(OITA) assisting the Agency with international projects and request for expertise abroad.
The International coordinator receives and coordinates requests from the OITA and the
Department of State regarding international visitors. This coordination includes proper
security vetting of the visitors through OITA and the Office of Homeland Security as
well as meeting logistics and working with management to select the appropriate
presenters. The international coordinator also works with management to distribute
announcements for projects abroad assisting foreign governments to establish
environmental rules and regulations.
1.7. Key Region 7 Personnel
1.7.1. Regional Administrator
The Regional Administrator is responsible to the Administrator, within the boundaries of
Region 7, for the execution of the Regional environmental programs of the Agency and
such other responsibilities as may be assigned. The direct responsibility for assuring data
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quality rests with regional Division and Office Directors. Ultimately, the Regional
Administrator is responsible for establishing quality assurance policy and for resolving
quality assurance issues identified through the quality system. Major quality assurance
related responsibilities of the Regional Administrator include the following:
Ensure that all Region 7 components and programs comply fully with the
requirements of this QMP;
Ensure that quality assurance is an identified activity with associated resources
adequate to accomplish program and Regional goals in planning, implementing,
and evaluating all environmental programs;
Ensure that all applicable environmental programs delegated to state, local, and
Tribal governments or performed by organizations outside EPA pursuant to EPA
mandates comply fully with the requirements of this QMP;
Ensure that quality assurance (QA) and quality control (QC) training is provided
to Regional management and staff, as defined by this QMP;
Ensure that state and local governments performing environmental data collection
for EPA have current EPA-approved QMPs as applicable;
Ensure that QA and QC training opportunities are provided to state and local
governments performing environmental data generation for EPA, as defined by
this QMP and allowable by available resources; and
Ensure periodic evaluations are conducted of internal and external environmental
programs to determine the effectiveness of their quality systems.
The Regional Administrator authorizes the Division and Office Directors to be
responsible for quality assurance development and implementation in accordance with
this QMP. The RQAM within ENST has been authorized to conduct oversight and
management of the Region 7 quality system.
1.7.2. ENST Division Director
The Environmental Sciences Division Director serves a dual role as Director of a
Regional division and as the Senior Staff member with oversight of the Regional quality
system. The Director is also designated as the Region's Scientific Integrity Official.
1.7.3. Deputy Division Director, ENST
The Deputy Division Director of ENST serves as the first line supervisor of the RQAM
and the QA Office.
Major responsibilities include:
Supporting the RQAM and other QA staff (collectively, the QA Office) with
required resources;
Meeting regularly with the RQAM to provide feedback and guidance on QA
matters;
Approving recommendations relating to QA matters; and
Advocating the QA Office cause and working to overcome barriers.
Peer Review Coordinator and NEPA Program Manager
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1.7.4. Quality Assurance Personnel
The RQAM is responsible for ensuring Region 7 management and staff understands the
requirements for the quality system as defined in the QMP. The RQAM and the
permanently assigned QA staff form the QA Office.
1.7.4.1.Quality Assurance Team - Regional Quality Assurance Manager
The RQAM is the authorized manager of the Region 7 quality system and has direct
access to the Regional Administrator on all matters pertaining to quality assurance.
Conditions which might require management intervention involving issues the QA
Office does not have the authority to unilaterally decide upon could include, but not
be limited to:
Significant or fundamental changes to Regional QA policy as set forth in this
QMP
New or changing QA training requirements different from what is
documented in the QMP
The need for additional QA resources such as FTEs, travel funds, training
dollars; and
Regional personnel or financial assistance recipients who knowingly and
willfully refuse to comply with Agency and/or Regional QA requirements.
The process to obtain management intervention would begin by the RQAM working
through the ENST Deputy Division Director for their support and assistance in
addressing the issues and for contacting other managers who may need to be
involved. For those issues that cut across programs and divisions, the ENST Division
Director would send an email to the RA, ARA, and the Staff Coordinator asking to be
placed on the agenda for the weekly Senior Staff meetings to brief them about the
situation and to get their concurrence on changes to Regional QA policy; their
agreement with new or changing QA training requirements; their support for
additional QA resources; their help with addressing any Regional personnel or
financial assistance recipient who refuses to comply with Agency and/or Regional
QA requirements, or their assistance with any other situation that might require
management intervention. If this process leads to disputes, the dispute resolution as
described in section 1.9 would be followed.
See Attachment A for the QA lines of authority and communication for the RQAM
and the QA Office. The main responsibility of the RQAM is quality assurance
oversight and ensuring that all personnel understand the QMP and their QA and QC
responsibilities. The RQAM reviews and approves a variety of quality system
documents and provides additional QA support as needed. The RQAM
responsibilities include:
Interpreting Agency QA policy and developing the QA policy for Region 7 in
accordance with Agency QA policies and direction from Regional
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management;
Maintaining the QMP in an up-to-date condition in regard to content and
conformity with Agency requirements, as appropriate;
Preparing a Quality Assurance Annual Report and Work Plan (QAARWP) for
the Regional Administrator and the Director of EQMD;
Reviewing and approving QMPs from regional, state, tribal, local, or other
governmental program offices, and contractors;
Assisting project officers, project managers, states, tribes, local governments
and other financial assistance recipients in developing QA documents and in
providing answers to technical questions;
Ensuring that all personnel involved in environmental data generation and use
have access to any training or QA information needed to be knowledgeable in
QA requirements, protocols, and technology;
Reviewing and approving quality assurance project plans (QAPPs) and other
project-level documents;
Reviewing and approving the QA review form submitted for contracts to
determine the necessary quality assurance requirements and to certify that the
review took place;
Reviewing and approving standard operating procedures (SOPs);
Assisting the Regional Laboratory in compliance with the Agency Policy
Directive, Assuring the Competency of Environmental Protection Agency
Laboratories. November 20, 2015,
Providing technical assistance to Regional programs with compliance with
Policy to Assure the Competency of Organizations Generating Environmental
Measurement Data Under Agency-Funded Assistance Agreements. FEM-
2012-02, March 13,2013.
Overseeing the implementation of internal and external QA management
evaluations;
Assisting in solving QA-related problems at the lowest possible organizational
level;
Serving as the Regional liaison with EQMD; and
Responding to evaluations performed on the Regional quality system and
establishing corrective actions.
The RQAM has the authority to carry out these responsibilities and to bring to the
attention of the Regional Administrator/Deputy Regional Administrator any issues
associated with these responsibilities. If the issues are in dispute, however, Section
1.9 of this QMP addresses dispute resolution.
1.7.4.2.Quality Assurance Office - Permanently Assigned QA Staff
The permanently assigned QA staff provides assistance to the RQAM in the oversight
and management of the quality system. The responsibilities of the permanently
assigned QA staff include:
Assisting the RQAM with the development and maintenance of the QMP;
Providing input to the QAARWP as requested;
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Reviewing QMPs from contractors, regional, state, tribal, local, or other
government program offices and commenting to RQAM on content;
Assisting with the development of quality system documents;
Reviewing QAPPs and other project-level documents, commenting on content
to RQAM, and recommending approval actions;
Reviewing SOPs and commenting on their content to the RQAM;
Developing and presenting QA training as required;
Assisting with the conduct of internal and external management evaluations
and technical evaluations as assigned; and
Providing technical assistance on QA-related issues as requested.
1.7.5. Division and Office Directors
The Division and Office Directors have overall responsibility for their respective quality
system. The Director is responsible for ensuring that quality assurance is an identifiable
activity within their program(s), for providing adequate resources to support quality
system efforts, and for accomplishing the quality assurance objectives of all intramural
and extramural environmental data activities within their program(s).
1.7.6. Supervisors
Supervisors are ultimately responsible for the quality of data and include all
supervisory personnel at the branch, unit, and section levels. The responsibilities for
supervisors include:
Assessing staff members' QA training needs and arranging for such training with
the RQAM;
Participating in a systematic planning process;
Assuring that QAPPs are in place before projects begin;
Ensuring that all sampling, analytical, and data-handling procedures performed
within the organization are consistent with accepted scientific principles and EPA
mandates, are documented, and adequately reviewed; and
Ensuring that corrective actions are implemented.
1.7.7. Project Officers/Project Managers/Work Assignment Managers
Project managers are defined, in the context of this QMP, as those individuals assigned
the responsibility of handling, directing, or managing a task or activity. Region 7 project
managers can include, but not be limited to, the following:
Project officers;
Team leaders;
Work assignment managers;
Compliance officers;
Remedial project managers;
Inspectors; and
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On-scene coordinators
For the purposes of this QMP, the term Project Manager will be used generically to
indicate any of the above positions or any other individual acting in the capacity of a
Project Manager. Project Managers are responsible for ensuring that the quality assurance
requirements in this QMP are met as they relate to their responsibilities. It is recognized
that the Project Manager may not have experience in quality assurance. Therefore, it is
critical that they work closely with the RQAM to be sure QA issues are appropriately
addressed including QA requirements related to grants, contracts, cooperative
agreements, interagency agreements, enforcement-related documents, and special
initiatives/projects. Project Managers have primary responsibility for coordinating the
following QA and QC activities:
Ensuring that work assignments, work plans, and contract deliverables include
appropriate QA documents;
Preparing and implementing approved QAPPs for intramural projects;
Ensuring that approved QAPPs are developed for and implemented in extramural
projects;
Coordinating with the RQAM on the selection and design of audits and
performance evaluation materials appropriate for the project;
Identifying, resolving, and implementing project-specific QA and QC issues
(which may include data quality assessment, information management, data
integration, and data validation); and
Providing review and approval of QAPPs from a programmatic perspective
1.8 Delegated and Authorized Programs
The following programs have been delegated or authorized to the states in Region 7:
RCRA - Subtitle C (hazardous waste): Nebraska and Kansas have the base
program, Missouri has the majority of the program, and Iowa has no delegation;
RCRA Subtitle I (underground storage tanks);
Air - Clean Air Act Title I permits, Title V permits, and most of Title III air
toxics;
Public Water Supply;
Underground Injection Control: Region 7 has direct implementation
responsibilities for Iowa;
Pesticides: all four states in Region 7 have primacy;
National Pollutant Discharge Elimination System;
Pretreatment: Kansas, Missouri and Nebraska have partial delegation;
Toxic Substances Control Act (TSCA);
402 of TSCA (Lead Training Certification program): All four states in the Region
are currently running the program with Iowa having received final approval; and
406 (b) of TSCA (Pre-Renovation Notification program): Kansas and Iowa are
running the program with Iowa having received final approval
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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 include oversight
through management systems reviews, program audits, and review and approval of QAPPs.
The Region's QA responsibilities in relation to those programs not delegated includes the
implementation of the quality system as defined in this QMP.
1.9 Dispute Resolution
For those situations in which issues regarding quality assurance are in dispute, resolution
should be sought at the lowest management level practicable. Such disputes may occur in
situations involving technical issues (e.g., audits, data quality assessments) and management
issues (e.g., QMP reviews, QAPP reviews, management system reviews).
All parties should make every effort to resolve disputes through discussion and negotiation.
Disagreements should be resolved at the lowest administrative level possible. Should
agreement not be reached at this level, the issue will be resolved by the Region 7
senior management team (office and division directors). The Region 7 Deputy Regional
Administrator has final dispute authority on all Region 7 quality assurance issues.
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2. QUALITY SYSTEM COMPONENTS
To meet its stated mission using environmental data, Region 7 must implement a quality
system that assures environmental data are of known and documented quality and can be used
for their intended purpose. The principal components of the Region 7 quality system are
quality system documents, management evaluations, project-level planning, project-level
documents, routine procedures documents, project-level evaluations, and quality system
personnel standards. The following tools are used in implementing the principal components of
the quality system:
Quality Management Plans (quality system documents)
Quality Assurance Annual Report and Work Plan (quality system documents)
Quality System Audits and Management System Reviews (management evaluations)
Annual Program Reviews (management evaluations)
Systematic Planning Process (project-level planning)
Quality Assurance Project Plans (project-level documents)
Generic Quality Assurance Project Plans (project-level documents)
Standard Operating Procedures (routine procedures documents)
Analytical Methods Manual (routine procedures documents)
Data Quality Assessments (project-level evaluations)
Technical System Audits (project-level evaluations)
Performance Evaluations (project-level evaluations)
Quality Assurance Training (quality system personnel standards)
Details regarding how the identified components are implemented and the responsibilities for
management and staff are included in the description for each quality system tool.
2.1. Quality System Documents
2.1.1. Internal Quality Management Plan
The Region 7 QMP contains the quality assurance policies, procedures, and management
systems governing the Region 7 quality system. The document 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
evaluating activities conducted. Management is implementing these quality assurance
policies to ensure that all environmental data generated for or by Region 7 are of known
and documented quality and are acceptable for their intended use as well as to promote
consistency across Regional programs in the management of field activities.
The QMP is developed by the RQAM with assistance, as appropriate, from the
permanently assigned QA staff and Division and Office Directors. The QMP is intended
for use by all Regional staff. A hardcopy of the QMP will be maintained by the Regional
QA Office. The QMP will also be accessible to all Regional staff through the Regional
Intranet and to external organizations through the Region 7 home page. Approval of the
QMP will include the RQAM, Division/Office Directors, and the Regional
Administrator. It will then be submitted for approval to the Director of EQMD. The
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approval is effective for up to five years, pending changes to the organization or
results from management system reviews. On or before the five-year anniversary, the
QMP will be updated as necessary and resubmitted for approval by the RQAM,
Division/Office Directors, Regional Administrator, and the Director of EQMD.
2.1.2. External Quality Management Plans
All applicants for Region 7 financial assistance involving environmental data generation
or use must prepare a QMP according to the most current version of EPA Requirements
for Quality Management Plans. EPA QA/R-2. The QMP must describe the management
policies, objectives, procedures, organizational authority, roles, and responsibilities to be
implemented by the organization to ensure environmental data are of the type and quality
needed for their intended use. The QMP will be reviewed by the RQAM or designee for
compliance with R-2 and the QMP Review Checklist (https://www.epa.gov/qualitv/epa-
qualitv-management-tools-organizations-and-programs ). The QMP must be approved by
the RQAM and the Regional Administrator for organizations receiving assistance for a
variety of environmental programs. The QMP must be approved by the RQAM, the
regional program manager, and/or the Regional Administrator for organizations receiving
assistance for an individual program.
The approval of a QMP is effective for five years unless significant changes are needed.
On or before the five-year anniversary date, the organization must resubmit the QMP for
the same approval as the original document; otherwise, the QMP will be considered out-
of-date and no longer applicable. If the anniversary date cannot be met, the organization
can request a one-time extension from the RQAM, not to exceed three months beyond the
anniversary date.
Under the EPA quality system, QMPs are supported by project-specific QAPPs;
however, there may be situations when a single document is applicable. Because of these
situations and the fact that the Region supports the use of the graded approach, the
RQAM may grant exceptions or modifications to the requirement for a QMP from an
organization receiving financial assistance from Region 7. Each exception or
modification will be determined on a case-by-case basis by the RQAM. A document in
place of a QMP will still be required but the content of this document will be defined by
the RQAM. In general, organizations receiving financial assistance may be granted an
exception or modification to the QMP requirement if they meet criteria which may
include, but not be limited to, the following:
small grants as defined by the EPA Small Grants Policy;
one-time, short-term, and special projects or projects of limited scope; and
organizations using or generating environmental data for public education
purposes
If an organization is granted an exemption or modification, it will be documented on the
Programmatic Certification-Authorization to Award an Assistance Agreement form (see
Section 4.2.1 of this QMP for further details) and will only apply to the QMP
requirement.
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2.1.3. Quality Assurance Annual Report and Work Plan (QAARWP)
The QAARWP is a summary of specific activities within the quality system. The
Region's implemented QA activities of the previous fiscal year are summarized in the
QAARWP. It will be prepared according to the direction received from EQMD by the
RQAM with cooperation from the permanently assigned QA staff and other Regional
staff as applicable. The QAARWP will also be used to identify minor changes or updates
to Region 7's QMP. The QAARWP will be submitted to EQMD on or before the
requested date and in the manner requested (e.g., electronically, hard copy, or both).
2.2. Management Evaluations
2.2.1. Quality System Audits (QSAs) and Management System Reviews (MSRs)
A quality system audit (QSA) or management system review (MSR) is a qualitative
evaluation of a data collection operation and/or organization(s) to establish whether the
prevailing quality management structure, policies, practices, and procedures are adequate
for ensuring that the type and quality of data needed are obtained. They are used to
determine the effectiveness of, and adherence to, the quality system and the adequacy of
resources and personnel provided to achieve and ensure quality in all activities. EQMD
plans to implement independent QSAs of the Region 7 quality system once every three
years. See Section 9.2.1 of this QMP for more information regarding QSAs.
MSRs of internal programs and external organizations will be conducted by the QA
Office as detailed in Section 9.2.1.2 of this QMP.
2.2.2. Program Reviews
The QA Team will participate in annual program reviews as identified in Section 9.2.2 of
this QMP.
2.2.3. Project Level Planning - Systematic Planning Process
A systematic planning process is a common sense, graded approach to planning projects
to ensure that the level of detail in planning is commensurate with the importance and
intended use of the work and the available resources. Section 7.2.1 of this QMP provides
additional detail regarding the use of systematic planning, including the Data Quality
Objectives process.
2.2.4. Project-Level Documents - Quality Assurance Project Plans
A QAPP is a project-level document describing in comprehensive detail the necessary
quality assurance, quality control, and other technical activities that must be implemented
to ensure that the results of work performed will satisfy the stated performance criteria.
The QAPP is also used as a means for documenting the results of a systematic planning
process. Policy and Program Requirements for the Mandatory Agency-wide Quality
System. CIO 2105.0, requires all applicable projects and tasks involving environmental
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data to have a written and approved QAPP prior to the start of the data generation or use.
See Sections 7.2.2 - 7.2.8 of this QMP for more information pertaining to the Region's
requirements for QAPPs.
2.2.5. Routine Procedures Documents
2.2.5.1.Standard Operating Procedures
Regional routine technical and administrative activities will be documented in an
SOP to ensure consistency in the quality of the product. The SOPs will include
thoroughly described steps and techniques and will be sufficiently clear to be readily
understood by a person knowledgeable in the general concept of the procedure.
Details regarding the Regional SOP System, the preparation, and the review and
approval process for SOPs are described in Section 8.3 of this QMP.
As a part of implementing the QAFAP requirements (aka, FOG), Region 7 has
created eight regional overarching SOPs which address how the Region will
implement these guidelines. These SOPs have been incorporated into the Regional
SOP system and are subject to the same preparation, review, and approval process
outlined in Section 8.3 of the QMP.
QAFAP SOPs may also be supplemented with program specific procedure documents
to provide additional detail on program activities not included in an overarching
QAFAP SOP. Each program will be responsible for addressing how they will create,
modify, review and approve their documents at the program or division level.
Program specific procedures, guidelines, and checklists should also be controlled in a
manner similar to the Regional SOPs.
2.2.5.2.Analytical Methods Manual
Laboratory analytical methods will be documented using the Environmental
Monitoring Methods Council format and will be compiled in the Region 7 Analytical
Methods Manual. Details regarding the Analytical Methods Manual and the review
and approval process are described in Section 8.4 of this QMP.
2.2.6. Project-Level Evaluations
2.2.6.1.Data Quality Assessments
A data quality assessment (DQA) is the scientific and statistical 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 use of the DQA process in
Region 7 is covered by Section 9.2.6 of this QMP.
2.2.6.2.Technical Systems Audits
Technical systems audits (TSAs) are a thorough, systematic, on-site, qualitative audit
of facilities, equipment, personnel, training, procedures, recordkeeping, data
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validation, data management, and reporting aspects of field and laboratory activities.
TSAs, as they apply to Region 7, are further described in Section 9.2.3 of this QMP.
2.2.6.3.0ther Technical Audits
Other types of technical audits can include, but not be limited to: readiness reviews,
surveillance, and audits of data quality. These types of audits, as they apply to Region
7, are further described in Section 9.2.4 of this QMP.
2.2.6.4.Performance Evaluations
A performance evaluation (also referred to as a performance testing sample) is a type
of audit where samples of known concentration are analyzed by a laboratory to
evaluate the proficiency of an analyst or laboratory. Additional detail regarding
performance evaluations can be found in Section 9.2.7 of this QMP.
2.2.7. Quality System Personnel Standards - Quality Assurance Training
Region 7 focuses on QA training to assure that QA responsibilities are recognized,
understood, and implemented by Regional staff. All Regional personnel involved with
environmental data generation or use will be required to have this QA training. The
specific QA training requirements for the different levels of Regional personnel are
detailed in Chapter 3 of this QMP. 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.
2.2.8. Information Quality Guidelines
EPA's Information Quality Guidelines (IQGs) contain EPA's policy and procedural
guidance for ensuring and maximizing the quality of information the Agency
disseminates and complements EPA's Quality System for assuring the quality of EPA's
products and information. "Information" generally includes any communication or
representation of knowledge or position/policy such as facts or data, in any medium, or
form. This includes "preliminary" information that EPA has endorsed or adopted, and
also conclusions or facts drawn from or based upon other, existing information. This
QMP incorporates by reference all definitions, principles, policies, and procedures found
in EPA's IQGs (found at the following link EPA IPGs).
2.2.8.1.Implementation Policy and Procedures
In accordance with EPA's IQGs, Region 7 has established policies and procedures for
complying with these guidelines, as described below, with emphasis on using existing
Regional processes or procedures wherever possible to comply with the requirements
of the IQGs. The review process is intended to ensure the quality of the Region's
disseminations and is described in the Region 7 Product Development and Approval
Plan which can be found at
http://r7atvvork.r07.epa.uov/intranet/oldr7/proceduresforms/opa/r7 product devlpmnt
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and apprvl pln.html. The Region 7 Product Review form can be found at
http://r7atvvork.r07.epa.uov/intranet/oldr7/proceduresforms/opa/pdf/r7 product rev f
orm.pdf. The Region 7 Information Quality Guidelines Officer is located within the
Office of Policy and Management which has taken the lead for IQGs.
2.2.8.2.Requests for Correction
The IQGs allow for affected persons to request correction of information if that
information does not comply with EPA or Office of Management and Budget
Information Quality Guidelines. The Office of Environmental Information (OEI) will
receive these complaints and forward them to the Region 7 IQG Officer when the
information in question belongs to or involves Region 7. In general, the process will
be as follows:
Upon receipt of the request for correction from OEI, the IQG Officer will determine
who in Region 7 has ownership of the information. The IQG Officer will forward the
request to the appropriate Division coordinator. The Division coordinator will then
manage the request for correction and ensure compliance with the 90-day turnaround
time for responding to these requests as established by the EPA IQGs.
The Region will notify the requester and take corrective action if the request is
approved. If the request for correction is not approved, the Region will notify the
requester and explain the reason for not approving the request.
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3. QUALIFICATIONS AND TRAINING
It is Region 7's policy to provide the quality assurance and quality control training necessary to
ensure that all persons involved in handling environmental data understand Region 7's quality
system. The following sections describe Region 7's QA training program and the requirements
for regional personnel involved with environmental data use and generation.
For activities and Regional personnel subject to the QAFAP requirements, details regarding the
identification of employee training needs, training delivery mechanisms, demonstration of
competency, and training and competency tracking can be found in the QAFAP overarching
SOP 1710.01, Regional Field Personnel and Training, current revision. Each program will be
responsible for developing any program-specific procedures, guidelines, and checklists to
supplement SOP 1710.01 as applicable.
3.1. Region 7's QA Training Program
To assist personnel with their responsibilities and requirements, Region 7 has developed a
formal training program. Region 7's QA Training Program consists of a core curriculum of
courses which are administered by the QA Team in conjunction with additional courses
which are administered by other regional offices, program offices, and EQMD. This section
describes the courses, the program logistics, and the associated documentation.
3.2. Courses
Region 7 has implemented a routine QA training program which includes several courses
offered on a routine basis. The Region 7 LAN Bulletin Board will be used to internally
announce scheduled training to Regional Office staff. An email list will be maintained by the
QA Office and used to announce scheduled training to our external partners. In general, the
core courses will be offered at least once a year, but will typically be offered two times
throughout the year depending upon available time and resources. The core courses are
summarized in Table 1.
Additional courses may be developed as the needs are identified. Additionally, courses
offered by the EQMD, other regions, and professional organizations may be invited to the
Region to provide support in non-routine areas as needed.
Table 1 Quality Assurance Core Courses
Course Title
Length
Comments
Orientation to Quality Assurance
4 hours
A detailed overview of the Agency's quality system
requirements and how they are implemented in Region
7
Systematic Planning Process
4 hours
An introduction to systematic planning with a detailed
focus on the DQO process
Quality Assurance Project Plans
4 hours
An in-depth review of QAPP format, content, review,
and approval requirements
Data Quality Assessment
4 hours
A basic introduction to DQA; intended for non-
statisticians
QA Refresher
2 hours
A briefing on updates/changes to the quality system;
required for Region 7 staff every 3 years
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Training courses covering SOPs and QMPs are also available and given upon request.
The QA training courses are tailored to target a specific audience (e.g., Senior Staff,
managers, Brownfields grantees, etc.) as requested and as resources allow.
3.2.1. Logistics
The RQAM and permanently assigned QA staff will provide the core courses on a routine
basis. The QA Team will maintain and archive the necessary documentation for training,
including copies of the course slides, related handouts, announcements, attendee lists,
attendee evaluations, and a database of attendees.
The minimum training requirements are described in the training requirements section
below. The RQAM and the ENST Division Director are responsible for granting any
variances or waivers for training. In order to grant a waiver for QA training, the
individual must initiate a request for a waiver. This request must be routed through the
requestor's Division Director and addressed to the ENST Division Director. The ENST
Division Director and the RQAM will grant a waiver based on a certificate of completion
for a functional equivalent course and the course outline or a memo of justification which
assures the Division Director and the RQAM that the individual understands the EPA
Quality System.
Additional QA training needs which have been identified by the divisions and program
offices will be provided when needed. Modifications to the core courses may be made to
address programmatic issues. However, each key topic must be described in order to
maintain the basic integrity of the original course.
3.2.2. Documentation of Training
After completion of a course, attendees will receive a certificate of completion from the
RQAM. For this reason, attendees at the courses will be recorded. The QA Office will
maintain a record of all QA training taken by all personnel in the Quality Assurance
Training Tracking System (QATTS). This database will provide the record of all QA
training, the necessary recertification information, and notes about any waivers.
At the end of each fiscal year, a summary of the QA training will be provided in the
QAARWP as requested.
3.2.3. Training Requirements
In order for the quality system to be effective and to be implemented in a consistent
manner throughout the Regional programs and organizations, staff need to be properly
equipped with the appropriate level of knowledge of quality assurance policies, principles
and procedures. The QA training program is intended to fulfill this need. The staff
members who are directly involved in the generation and/or use of environmental data
are the primary focus of the training program. However, there are others (such as
supervisors and projects managers) who should have at least a familiarity with QA.
Region 7's training program incorporates a tiered approach relative to the functions
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performed by the various groups of personnel. This section outlines the minimum QA
training requirements for the various groups of personnel.
3.2.3.1.Management
Division and Office Directors are responsible for ensuring the Region 7 quality
system is implemented as described and the resources are available in meeting the
criteria of the system. Therefore, it is critical that management has a good
understanding of the quality system and quality management issues described in the
regional QA training course "Orientation to Quality Assurance for Managers". The
individual Divisions and Program Offices with the necessary assistance from the
RQAM are responsible for identifying needed QA training within their organizations.
3.2.3.2.Supervisors
Supervisors are ultimately responsible for the quality of data. Therefore, it is critical
that supervisors receive the necessary awareness training to ensure their
understanding of the importance of quality assurance, their responsibilities as
supervisors of environmental data activities, and specific Region 7 quality assurance
policies and procedures. Toward that end, supervisors who oversee environmental
programs which generate or use environmental data should attend the "Orientation to
Quality Assurance" course. Additional training, including an introductory course
tailored to supervisors' needs, may be provided depending on the specific duties and
responsibilities of the individual.
On an annual basis, a report listing the QA training completed by their staff will be
sent to each supervisor. A request asking the supervisor to identify any changes to
their staff and QA training needs for their staff for the upcoming year accompanies
this report.
3.2.3.3.Project Managers, Lab and Field Personnel
Project managers, lab personnel, and field personnel are responsible for ensuring that
all projects are conducted with known quality, and are in compliance with the agency
standards. In the performance of these functions, the project manager prepares or
reviews QAPPs. Therefore, it is critical that project managers receive the necessary
training, including "Orientation to Quality Assurance", "Systematic Planning Process
and Quality Assurance Project Plans", and "Data Quality Assessment". Additional
training may be identified by the project manager, their supervisor, or the RQAM.
3.2.3.4.Permanently assigned QA Staff
Permanently assigned QA Staff are responsible for assisting the RQAM with quality
issues. As part of this responsibility, the permanently assigned QA Staff will assist in
writing or reviewing quality documents, including QAPPs, SOPs, and QMPs.
Therefore, it is critical that the RQAM and permanently assigned QA Staff receive
the necessary training, including "Orientation to Quality Assurance," "Systematic
Planning Process and Quality Assurance Project Plans," "Data Quality Assessment,"
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"Standard Operating Procedures," and "Quality Management Plans." Additional
training, such as auditor training, may be identified by their supervisor or the RQAM.
3.2.3.5.RQAM
The RQAM is responsible for identifying training needs, disseminating information
regarding available training opportunities for Region 7 staff and management, and
arranging region-wide quality assurance training as appropriate. Specifically, the
RQAM will ensure that:
Coordination occurs with supervisors to provide QA training for them and
their staff as requested and as resources allow, including ensuring project
managers and EPA personnel have a minimum of 16 hours QA training;
Quality Assurance personnel will have a minimum of 24 hours training. Any
additional QA training to perform specific duties such as auditing or trainer
training, and any technical training which would facilitate the understanding
of the Agency's operations would be discussed in the individual's mid-year
and annual performance appraisal;
The QA training is made available to all grantees including State and Tribal
personnel;
QA Refreshers are routinely offered to ensure Regional Office staff get
recertified in a timely manner; and
Any special training requests by EPA, state, or tribal personnel are
coordinated.
The RQAM is responsible for arranging or providing for the training needs
identified by the Divisions and Program Offices.
3.2.4. Recertification
All personnel who are involved in environmental data generation and use will be required
to attend "QA Refresher Course" every three years (± 6 months) to maintain their quality
assurance proficiency. Prior to presenting the "QA Refresher Course," the RQAM will
notify staff and their supervisor that they are due for a refresher.
3.2.5. Assurance for Grants and Contracts
Minimum QA training requirements for grant recipients or contract personnel involved
with environmental data generation or use should be described in the organization's
approved QMP. Grantees with a current relationship with EPA are welcome to attend the
Region 7 QA training courses. Contractors may attend the training at the written request
of their contracting officer or their designee. Project Managers are responsible for
providing information about the Region's QA training to their grant recipients or contract
personnel involved with environmental data generation or use to help ensure they have
the necessary QA training to successfully complete their granted or contracted tasks and
functions.
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4. PROCUREMENT AND FINANCIAL ASSISTANCE
It is Region 7's policy to state the designated quality assurance and quality control
requirements when acquiring items and/or services that may result in or relate to environmental
programs. Within Region 7, procurement functions are conducted in accordance with the
Federal Acquisition Regulations and generally accepted business practices for the acquisition
process. The Region 7 Quality System does invoke the Agency's graded approach. This
approach allows the RQAM a certain degree of latitude in the requirements set forth below.
Any deviation from the requirements set forth below must be documented in the
project/contract file.
4.1. Procurement - Contracts
All procurements originating at Region 7 must meet established administrative and
quality assurance requirements in the latest editions of:
the Federal Acquisition Regulations, Part 13;
the Acquisition Handbook (AH); and
the Contracts Management Manual (CMM).
Quality assurance requirements for contracts are set forth in the EPA Contracts
Management Manual (Section 7.3.5.3 and Chapter 46) and the Federal Acquisition
Regulation (FAR) 46.202-4 and 52.246-01.
Requirements include the QA Review Form, or other program-specific QA review form,
that includes, as a minimum, the information shown in Attachment B. The QA review
form shall be completed as required and signed by the Project Manager and the RQAM to
assure that all environmentally related measurements which are funded by EPA or which
generate data mandated by EPA are scientifically valid, legally defensible, and of known
and documented quality.
Region 7 contracts (as opposed to those originating at Headquarters) involving
environmental programs shall submit a QMP prepared in accordance with the
specifications provided in the most current version of EPA Requirements for Quality
Management Plans (QA/R-2), which describes the quality system implemented by the
applicant. The QMP shall be reviewed and approved by the EPA Contracting Officer, the
EPA Project Manager, and the RQAM as described in Section 2.1.2 of this QMP as a
condition for award of any contract. The QMP must be submitted as part of the
application.
If the QMP is not submitted as part of the application and EPA decides to award the
contract, EPA will include a term and condition in the contract. This term and condition
requires the recipient to submit the QMP within a specified time after award of the
contract and notifies the recipient that they may not begin work involving environmental
programs until the EPA Contracting Officer informs them that the QMP has been
approved.
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The contractor shall also be required to submit QAPPs to EPA for review and approval
by the EPA Project Manager and the RQAM as described in Section 7.2.3 of this QMP
before undertaking any work involving environmental programs. All QAPPs shall be
prepared using the most current version of EPA Requirements for Quality Assurance
Project Plans (QA/R-5), which describes the quality assurance and quality control
activities to be implemented to satisfy the performance criteria for the work involving
environmental programs.
There may be instances where deviations to these requirements such as submittal of a
single document or use of a modified format would be appropriate. Any such deviations
will be clearly documented and must have concurrence by the appropriate contracting
officer and the RQAM.
When a contract originates at the Regional level and involves the generation or use of
environmental data, the RQAM will be included as part of the Technical Evaluation
Panel (TEP) to evaluate the adequacy of the QA documents required. The TEP develops
the evaluation criteria and the Statement of Work for the solicitation and performs the
technical evaluation of offers.
4.2. Financial Assistance
4.2.1. Grants and Cooperative Agreements
The applicant shall complete a Quality Assurance Requirement form (see Attachment E)
indicating whether the assistance involves environmental data generation or use. A
narrative description of the program or project associated with the assistance is provided
with Standard Form 424 (SF-424, see Attachment C). The description contains 5 parts:
1) Objective;
2) Results or Benefits Expected;
3) Approach;
4) General Program/Project Information, and
5) Quality Assurance Requirement.
The decision on whether a grant or cooperative agreement involves environmental data
generation or use is determined by the EPA Project Manager in consultation with the
RQAM and a review of the narrative description provided with the SF-424. The
Programmatic Certification-Authorization to Award an Assistance Agreement form is
signed and dated by the EPA Project Manager (see Attachment D).
All applicants for grants or cooperative agreements involving environmental data
generation or use programs shall submit a QMP prepared in accordance with the
specifications provided in the most current version of EPA Requirements for Quality
Management Plans (QA/R-2), which describes the quality system implemented by the
applicant.
The applicant's QMP shall be reviewed and approved as described in Section 2.1.2 of this
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QMP as a condition for award of any assistance agreement. The QMP must be submitted
as part of the application. If the QMP is not submitted as part of the application and EPA
decides to fund the project, 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 after award of the agreement and notifies the recipient that they may not
begin work involving environmental programs until the EPA Project Manager informs
them that the QMP has been approved. Modification or exceptions to the requirement for
a QMP may be granted by the RQAM as identified in Section 2.1.2 of this QMP.
The recipient shall also be required to submit QAPPs to EPA for review and approval by
the EPA Project Manager and the RQAM before undertaking any work involving
environmental programs. All QAPPs shall be prepared using the most current version of
EPA Requirements for Quality Assurance Project Plans (QA/R-5), which describes the
quality assurance and quality control activities to be implemented to satisfy the
performance criteria for the work involving environmental programs. Section 7.2.3 of this
QMP provides additional detail regarding the review and approval of QAPPs in Region 7.
There may be instances where deviations to these requirements such as submittal of a
single document or use of a modified format would be appropriate. Any such deviations
will be clearly documented and must have concurrence by the appropriate project officer
and the RQAM
Approval of the recipient's QMP may authorize the recipient to review and approve
QAPPs, in place of the RQAM, based on procedures documented in the QMP. Section
7.2.4 of this QMP describes Region 7's policy and process for this authorization.
Oversight of an organization's QAPP approval process will be part of the MSR process
as described in section 9.2.1.2 of this QMP.
Oversight of QA requirements in the grants and cooperative agreements process is
included in the MSRs and program reviews performed by the QA Office on specific
environmental programs (see Section 9.2.1.2 of this QMP). MSRs of both internal
programs and external organizations will include a random sampling of the projects for
that program or organization (a list of the projects will be requested from the program or
organization as part of the MSR) to determine if the projects were correctly identified as
including environmental data generation and/or use and if the QA requirements,
including approved QAPPs prior to environmental data generation and/or use, were
applied and adequately addressed. Additional mechanisms will be developed as needed
through the Regional Grants Customer Relations Council established to provide a region-
wide forum for the discussion and resolution of matters relating to the management of
EPA's assistance programs. The Council includes the Senior Resource Official, the
Grants Management Officer, up to two representatives from each division/office with
responsibilities for managing assistance activities, grant management specialists and the
Financial Management Officer.
4.2.2. Interagency Agreements
Interagency agreements that are funded by EPA should include QMP and QAPP
requirements in the agreement. Because EPA cannot unilaterally impose such
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requirements, these requirements must be negotiated into each agreement.
The QMP shall be prepared in accordance with the specifications provided in the most
current version of EPA Requirements for Quality Management Plans (QA/R-2), which
describes the quality system implemented by the party involved in the environmental
program. The prepared QMP shall define the approving officials of the QMP; minimally,
this will be the EPA RQAM.
The QMP shall be supported by QAPPs which are submitted to EPA for review and
approval before undertaking any work involving environmental programs. All QAPPs
shall be prepared using EPA Requirements for Quality Assurance Project Plans
(QA/R-5), which describes the quality assurance and quality control activities to be
implemented to satisfy the performance criteria for the work involving environmental
programs. The prepared QMP shall define the approving officials for QAPPs; minimally,
this will be the RQAM.
4.2.3. FEM Competency Policy
To comply with Agency Policy Directive Number FEM-2012-02, Policy to Assure the
Competency of Organizations Generating Environmental Measurement Data under
Agency-funded Assistance Agreements. Region 7 has determined the following approach
to be acceptable as adequately demonstrating competency and meeting the requirements
of this Policy for assistance agreements which include the generation and/or use of
environmental data and that exceed a total of $200,000 in federal funds.
4.2.3.1.States
The state may document their compliance with the Policy through their QMP and this
documentation can include, but not be limited to, any of the options or combination of
options listed below:
For personnel:
A description of any training program for staff collecting samples or field
measurements that includes a review of relevant procedures and methods, a
commitment from staff to comply with said procedures and methods, on-the-
job field training, and documentation of successful completion of that training.
How successful completion of the training will be documented, who will be
responsible for ensuring completion of the training, and how it will be ensure
personnel competency is maintained needs to be included.
A description of the processes in place for the hiring of personnel relevant to
the subject of the award and how it will be ensured that relevant personnel are
in place prior to environmental data activities.
A description of any formal personnel certifications and/or accreditations, PT
testing, or other EPA accepted audits/assessments of proficiency
demonstration relevant to the subject of the award including the source(s) of
such personnel proficiency demonstration, how this is documented, and how it
will be ensured the proficiency demonstration is maintained.
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For laboratories:
A description of any formal laboratory certification and/or accreditations,
PT testing, or other EPA accepted audits/assessments of proficiency
demonstration relevant to the subject of the award including the source(s)
of such laboratory proficiency demonstration, how this is documented, and
how it will be ensured the proficiency demonstration is maintained.
A description of the processes in place for the selection of a laboratory to
perform environmental data activities relevant to the subject of the award
and what quality system documentation is required, such as laboratory
quality manuals or QMPs that describe the organization's quality practices
and detailed standard operating procedures, and who will be responsible
for ensuring such quality system requirements and documentation are in
place.
For pass-through funds to sub-recipients and/or sub-contractors, the State will have
the burden for proof and responsibility for meeting the demonstration of competency
in compliance with the Policy.
Any unique or specialized competency documentation required for a particular
project in addition to that described above will need to be addressed on a project-
specific basis through the relevant QAPP.
At any time, the EPA Project Officer may request that a copy of the competency
documentation described above be submitted as part of the grant award.
4.2.3.2.Tribes and other grantees
To demonstration compliance with the competency policy, Section A8 of the QAPP,
Special Training/Certification Requirements, can include, but not be limited to, any of
the options or combination of options listed below:
For personnel:
A description of any training program for staff collecting samples or field
measurements that includes a review of relevant procedures and methods, a
commitment from staff to comply with said procedures and methods, on-the-
job field training, and documentation of successful completion of that training.
How successful completion of the training will be documented, who will be
responsible for ensuring completion of the training, and how it will be ensure
personnel competency is maintained needs to be included
A description of the processes in place for the hiring of personnel relevant to
the subject of the award and how it will be ensuring that relevant personnel
are in place prior to environmental data activities.
A description of any formal personnel certifications and/or accreditations, PT
testing, or other EPA accepted audits/assessments of proficiency
demonstration relevant to the subject of the award including the source(s) of
such personnel proficiency demonstration, how this is documented, and how it
will be ensured the proficiency demonstration is maintained; the results of any
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related assessments can be addressed in Section CI of the QAPP, Assessments
and Response Actions
For laboratories:
A description of any formal laboratory certification and/or accreditations,
PT testing, or other EPA accepted audits/assessments of proficiency
demonstration relevant to the subject of the award including the source(s)
of such laboratory proficiency demonstration, how this is documented, and
how it will be ensured the proficiency demonstration is maintained; the
results of any related assessments can be addressed in Section CI of the
QAPP, Assessments and Response Actions
A description of the processes in place for the selection of a laboratory to
perform environmental data activities relevant to the subject of the award
and what quality system documentation is required, such as laboratory
quality manuals or QMPs that describe the organization's quality practices
and detailed standard operating procedures, and who will be responsible
for ensuring such quality system requirements and documentation are in
place
For pass-through funds to sub-recipients and/or sub-contractors, the State will have
the burden for proof and responsibility for meeting the demonstration of competency
in compliance with the Policy.
At any time, the EPA Project Officer may request that a copy of the competency
documentation described above be submitted as part of the grant award
4.2.3.3.Region 7 QA Office and Project Officer Responsibilities
EPA-approved QMPs are kept on file by the Regional QA Office and are available to
Project Officers for review to verify the competency demonstrations options for a
particular state.
Because QAPPs are not routinely maintained by the Regional QA office, the Project
Officer is responsible for maintaining either a copy of the QAPP in the grant file or
other equivalent documentation showing EPA approval of the QAPP (e.g., the QA
approval memo, copy of the signed QAPP signature page) and demonstration of
competency in compliance with FEM-2012-02.
Documentation of any project relevant personnel or laboratory certifications and/or
accreditations will not be submitted to nor maintained by the Regional QA office but
may be submitted directly to the Project Officer as requested. The Regional QA
Office will provide assistance to the Project Officer in reviewing and determining the
adequacy of such documentation as needed.
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5. DOCUMENT AND RECORDS MANAGEMENT
It is Region 7'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. Region 7 adheres to the most current version of the
Agency records management procedures including the National Archives Records
Administration and Records Management Policy (EPA 2155.13, February 2015) and EPA
Records Schedule 1006b.
Project level quality-related documents and records (both printed and electronic) will be
identified by the EPA Project Manager. 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.
The EPA Project Manager is responsible for preparing, issuing, using, and revising Quality
Assurance Project Plans (QAPPs) in accordance with Sections 7.2.2-7.2.8 of this QMP, as
applicable. The RQAM is responsible for reviewing and approving all QAPPs in accordance
with the most current version of EPA Requirements for Quality Assurance Project Plans for
Environmental Data Operations. EPA QA/R-5. The RQAM is responsible for preparing,
issuing, using, and revising the Regional QMP in accordance with the most current version of
EPA Requirements for Quality Management Plans. EPA QA/R-2. The Regional QMP requires
review and approval by EPA personnel outside of Region 7, but this review is beyond the
scope of this document.
When QAPPs are approved by the RQAM, they are returned to the Project Manager. The
RQAM does not maintain archival copies of project level quality-related documents, though
temporary copies may be kept as needed for the convenience of the QA Office. The Project
Manager 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 policies and guidance listed above. The Project Manager 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 and Region 7 SOP
1330.5, Handling and Disposition of Regional Quality Assurance Files, current revision.
Regional Counsel is responsible for managing the custody and confidentiality of evidentiary
quality-related documents and records in accordance with applicable regulations. Regional
Records Center staff and resources are available to assist in carrying out these responsibilities.
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6. COMPUTER HARDWARE AND SOFTWARE
The Environmental Protection Agency's ability to fulfill its mission is dependent upon a strong
information technology infrastructure. Mission objectives rely on an infrastructure that is
capable of supporting environmental information and dynamic communication among EPA
offices. One of the most critical components of the EPA infrastructure is information
technology. The hardware, software, and communications components that are encompassed
by information technology form the foundation for environmental information and EPA-wide
communication. The management of information technology, therefore, is critical to the
success of the EPA.
The Office of Environmental Information and the National Technology Services Division
(Office of Technology Operations and Planning, Office of Environmental Information) are
responsible for managing the EPA's information technology infrastructure and components. In
that role, the Office of Environmental Information and the National Technology Services
Division have established information technology standards to manage and ensure that
information technology components integrate properly into the infrastructure.
6.1. Region 7 Information Management System
All information management system development, improvements, and updates will comply
with EPA Directive 2100, Information Resources Management Policy Manual to include a
systematic and comprehensive dialogue among the data providers, data and system users, and
system developers, prior to the design of the system.
It is Region 7 policy to work closely with the Office of Environmental Information on all
phases of system development, improvements, and updates. During the operational phases of
information management systems, Region 7 will comply with requirements within EPA
Directive 2100 Information Resources Management Policy Manual and the most current
version of the System Life Cycle Document which assists all EPA Regional offices in
complying with EPA Information Resource Management (IRM) standards by establishing a
set of guidelines for all new and enhancement/replacement systems under development. It
can be found at http://r7atvvork.r07.epa.gov/intranet/information sources/pdf/irmb sdlc.pdf.
This procedure will be administered by the Information Resource Management Branch
(IRMB) within the Region. IRMB will oversee all stages of the systems life cycle
management process to ensure conformance to EPA IRM standards, improve systems
quality, and develop more efficient and cost-effective systems. The centralization of this
function will establish a consistent methodology for use throughout the Region. This
oversight will include review and approval of all system front ends (user interface) and back
ends (databases, etc.), complete documentation of all system development efforts (analysis,
design, code, variables, processes, etc.) using standard documentation formats and forms that
are maintained by the IRMB.
This document defines the different stages of the EPA-standard "generic" system
development life cycle, lists points of contact for each stage, explains the required
documentation, and provides a "checklist" of activities that must occur during each stage.
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Please note that this document does not replace EPA IRM policies and procedures. Instead, it
seeks to simplify and enumerate these policies and procedures and to establish one standard
approach for systems development documentation practices. Much of the information in this
document has been taken directly from EPA directives. Where available, web links to more
information have been provided.
Region 7 is moving to performance-based contracts, so for IT contracts that involve
applications development, the performance work statement will include, but not be limited
to, requirements for system specification reviews; system development plans; data validation
and transfer; acceptance testing, and report generation.
6.2. Hardware and Software Requirements
In addition to the System Design and Development Guidance and Operations and
Maintenance Manual Region 7 will comply with the Office of Administration and Resources
Management's Delegation of Procurement Authority Guide. This will ensure that purchased
software will meet user requirements and will comply with the Office of Environmental
Information.
6.3. Data Standards
All Federal agencies are required to adhere to Federally mandated data standards and
regulations. It is the policy of Region 7 to comply with all applicable regulations, guidance,
executive orders, and internal policy documents concerning data standards. These include:
The National Institute of Standards and Technology;
The Federal Information Processing Standards; and
The EPA Data Standards Program (https://www.epa.gov/data-standards/find-epa-
data-standard)
EPA's data-related policies apply to all EPA organizations and personnel, including
contractors, Senior Environmental Employee (SEE) Program participants, and other personnel
assigned to EPA who design, implement, and maintain information management systems for
Region 7 and EPA.
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7. QUALITY PLANNING
7.1. Annual Planning
The primary vehicles for annual planning in the Region are the Agency Operating Guidance,
the budget process, a Regional Plan (that somewhat resembles a work plan), Performance
Partnership Agreements (PPAs), and state annual program work plans.
The PPAs describe overall operating objectives and goals between EPA and the state
agencies. The individual program managers negotiate with each appropriate state agency to
obtain commitments from them on the work they will complete during the fiscal year. These
negotiations with the state agencies result in the preparation of the annual program work
plans by the state agencies. The QA needs for a state are identified through the PPA process
and the lead project officers on these PPAs, many of whom are representatives on the GCRC
with the RQAM, are responsible, in consultation with the RQAM, for identifying and
specifying the QA needs for a PPA including QMPs. The RQAM maintains a status table for
external QMPs on the intranet which all Region 7 staff, including PPA project officers, have
access to. The QA needs are then identified through conditions placed in the PPA. The PPA
project officers are responsible for tracking the status of all conditions, including QA
conditions, and for verifying they have been met. The required QA documentation is
submitted to the RQAM for review and approval through the Project Officer.
The end result of the above efforts is the establishment of overall operating plans for the
Region to meet the goals within each program based on state, Regional, and other available
resources. The planning for QA is fully integrated into this annual planning process. Any
specific QA requirements are included in the PPAs as a condition for grant approvals or in
the annual program work plans.
7.2. Project-level Planning
7.2.1. Systematic Planning Process
A systematic planning process shall be used for all environmental programs conducted by
or for Region 7. The Data Quality Objectives process as described in the most current
version of Guidance for the Data Quality Objectives Process, EPA QA/G-4, is
recommended and encouraged by the Region but is not mandatory except for SUPR as
noted in the OSWER Directive. Any other systematic planning process that is used must
include the elements defined in Chapter 3 of the EPA CIO 2105-P-01-0. The Project
Manager is responsible for ensuring that a systematic planning process is used and
documented. Guidance and technical support in using a systematic planning process will
be provided by the QA Office as requested.
For activities and personnel subject to the QAFAP requirements, all field project
planning will be conducted and documented in accordance with this section of the QMP
and the QAFAP overarching SOP 1740.02 Regional Field Activity Planning, current
revision. Where applicable, each program will be responsible for developing and
documenting any program-specific procedures for targeting and planning field projects
and for documenting the results of planning field projects to supplement this QMP and
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SOP 1740.02.
7.2.2. Quality Assurance Project Plans
All projects and tasks involving the generation or use of environmental data (as defined
in Section 2.1 of this QMP) that are conducted by or for Region 7 shall have an
approved QAPP in place prior to the start of data generation or use. It is the responsibility
of the Project Manager to ensure an approved QAPP is in place prior to the start of data
generation or use. This includes QAPPs prepared for projects or tasks involving
environmental data to be performed by Regional staff or through grants and cooperative
agreements (40 CFR Parts 30, 31, and 35), and contracts (48 CFR Chapter 15, Part 1546).
Interagency agreements are addressed separately in Section 4.2.2 of this QMP. Oversight
to ensure Regional projects and projects funded by EPA through financial assistance
agreements or contracts will be performed through internal and external MSRs and
program reviews by the Region 7 QA Office. These reviews will include a random
sampling of the projects for that program or organization (a list of the projects will be
requested from the program or organization) to determine if the projects were correctly
identified as including environmental data generation and/or use and if the QA
requirements, including approved QAPPs prior to environmental data generation and/or
use, were applied and adequately addressed.
7.2.3. Quality Assurance Project Plan Preparation, Review, and Approval
Quality Assurance Project Plans are prepared, reviewed and approved in accordance with
the most current versions of EPA Requirements for Quality Assurance Project Plans for
Environmental Data Operations. EPA QA/R-5, and Guidance on Quality Assurance
Project Plans. EPA QA/G-5. All QAPPs prepared by or for Region 7 will be approved by
the RQAM or designee for QA requirements and by the Project Manager for technical
and programmatic requirements. This includes QAPPs prepared for projects or tasks
involving environmental data to be performed by Regional staff or through grants and
cooperative agreements (40 CFR Parts 30, 31, and 35), and contracts (48 CFR Chapter
15, Part 1546). Interagency agreements are discussed separately in Section 4.2.2 of this
QMP.
Based upon the graded approach, there may be instances when an alternate or modified
QAPP format is more appropriate for a project than that required by R-5. Any such
modifications to the R-5 requirements must be developed in cooperation with and
approved by the RQAM.
The Region 7 SOP 1330.2, Review of Project-level Quality Assurance Related
Documents, current revision describes in detail the Region 7 process for the review and
approval of QAPPs submitted to the RQAM. All QAPPs must be submitted to the
RQAM through the Project Manager. Once a QAPP is received the RQAM or designee
will review it for compliance with the requirements outlined in R-5 (as identified above).
A QAPP review checklist may also be used to facilitate the review. An example review
checklist can be found in Appendix C in Guidance on Quality Assurance Project Plans.
EPA QA/G-5 (https://www.epa.gov/sites/production/files/2015-06/documents/g5-
fmal.pdf).
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The completed checklist is for internal use by the QA Office and is not provided to the
Project Manager or others outside the QA Office; however, a copy of a blank QAPP
review checklist is available for use by others on the Region 7 home page. Comments are
provided to the Project Manager through four types of review memoranda:
Approved - the document complies with R-5 and addresses the key issues
satisfactorily.
Approved with comments - although the document satisfactorily addresses most
of the key issues and complies with R-5, minor issues were noted. These issues
should not have a direct impact on the quality of the resulting data, but are
noteworthy of pointing out for the record.
Approved with conditions - the document was found to be incomplete in
addressing some key areas to the extent of potentially jeopardizing the quality of
the data. These areas are fully described in this review memorandum and can be
adequately addressed by incorporation into the document but without
resubmission.
Resubmission Requested - the document was found to be insufficient in
describing the key issues. Further clarification of specific issues is required prior
to approval of the plan and initiation of the data collection activity.
Once all critical issues have been addressed, the RQAM will sign the QAPP and return it
to the originator of the review. The approval will be effective for the length of the project
or for five years; whichever is less unless significant changes are needed (see Section
7.2.8 for how revisions are handled). If the QAPP will be used beyond the original length
of the project or beyond five years, the QAPP must be submitted for the same approval as
the original document.
The QA Office will keep only a file copy of the final review memorandum and a copy of
the completed QAPP signature page. The original document including the original signed
signature page will be returned to the EPA project manager. See Chapter 5 of this QMP
for additional details regarding the retention and maintenance of quality-related
documents and records.
7.2.4. Quality Assurance Project Plan Review and Approval Authorization
Some organizations can be authorized to approve some QAPPs in place of the RQAM
where federal regulations allow. In order to receive this authorization, an adequate and
appropriate process for the development, review, approval, and revision of QAPPs within
the organization or program must be documented in an approved QMP. The QMP must
be prepared, reviewed, and approved as defined in Section 2.1.2 of this QMP. Other
organizations cannot be authorized to approve QAPPs, in place of the RQAM, for
Superfund pre-remedial (40 CFR 35 Subpart O), remedial (40 CFR 35 Subpart O), and
removal projects (40 CFR 300). QAPPs falling into these categories must be forwarded to
the RQAM for review and approval as previously identified. Oversight of an
organization's QAPP approval process which has been authorized by an approved QMP
will be part of the MSR process as described in section 9.2.1.2 of this QMP.
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Due to changes in the Superfund regulations, Brownfields and State Response Program
activities, although CERCLA, are no longer funded through the Superfund Trust (these
are now STAG grants) and have been determined to not be subject to 40 CFR Part 35,
Subpart O. Therefore, states, tribes, local governments, Regional programs, and other
organizations can be authorized to review and approve QAPPs prepared in support of
these Brownfields activities in place of the RQAM. In order to receive this authorization,
the same criteria as described above for an adequate and appropriate process for the
review, approval, and revision of these QAPPs apply, and this process must be
documented in an organization's approved QMP. Oversight of an organization's QAPP
approval process which has been authorized by an approved QMP will be part of the
MSR process as described in section 9.2.1.2 of this QMP.
Because of resource constraints and to facilitate the Brownfields process, Region 7 may
request assistance from a state program with the review and approval of QAPPs for non-
state EPA grantees. For this to occur, the state program must be authorized, as described
in the first paragraph of this section through an approved QMP, to review and approve
QAPPs in lieu of the RQAM. Review and approval of non-state EPA Brownfields
grantee QAPPs by a state program will be limited to those instances where there is
mutual agreement among the parties involved (the state, Region 7, and the grantee), and a
relationship has been established between the state program and the non-state EPA
grantee following the guidelines established by the state for their Brownfields program.
The request for such assistance will be made through the EPA Project Officer in
consultation with the RQAM as necessary. Oversight of an organization's QAPP
approval process for Brownfields which has been authorized by an approved QMP will
be part of the MSR process as described in section 9.2.1.2 of this QMP.
Per OSWER Directive 9272.0-17, the UFP-QAPP is designated for use in Federal
facilities projects where environmental data are collected. The UFP-QAPP may be used,
but is not currently required, for other non-Federal facilities projects in Region 7. Any
QAPP prepared in compliance with the UFP-QAPP requirements is also in compliance
with R-5.
7.2.5. Generic Quality Assurance Project Plans
For multiple projects or sites with the same objectives and environmental decision(s), a
generic QAPP may be prepared. The generic QAPP will still be prepared according to the
most current version of EPA Requirements for Quality Assurance Project Plans for
Environmental Data Operations. EPA QA/R-5, and Guidance on Quality Assurance
Project Plans. EPA QA/G-5, but will address the issues which remain constant among the
different projects or sites. Generic QAPP must also be supported by site-specific or
project-specific addenda which address the issues unique to each site or project. The
generic QAPP will specify the preparation, review, and approval of the site-specific or
project-specific addenda. Generic QAPPs require a QA review and approval by the
RQAM and a technical and program review by the Project Manager. The QA approval of
generic QAPPs for external organizations can be authorized in a similar manner as
described in Section 7.2.4 of this QMP. The appropriateness of a generic QAPP is
determined on case-by-case basis by the Project Manager in cooperation with the RQAM.
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7.2.6. Regulated Facilities
Programs are encouraged to include QA and QAPP requirements in permits and other
compliance documents to ensure data of known and documented quality are obtained and
to ensure sound environmental decision making. NPDES permit requirements and Region
7 SOP 2332.2, NPDES Compliance Sampling Inspections, current revision have been
determined to adequately cover the environmental data generation activities performed by
the Regional NPDES inspectors and are used in lieu of a traditional QAPP.
7.2.7. Quality Assurance Project Plan Implementation
The Project Manager is responsible for ensuring that QAPPs are implemented. This can
be done on an informal basis using routine on-site surveillance or project status reports
(or other project reports as required and identified in the project-specific QAPP). The
Project Manager can also use a more formal process like a TSA to ensure implementation
of a QAPP. The TSA can be done with the assistance of the QA Team upon request. The
use of a TSA (or some other evaluation) will be identified and described in each QAPP.
7.2.8. Quality Assurance Project Plan Revision
Any revisions required to the approved QAPP can 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 Manager in consultation with the RQAM as
needed) and affect the scope and objectives of the project, data use, or data quality, the
revised QAPP or addendum must be reviewed and approved in the same manner as the
original QAPP. The Project Manager is responsible for ensuring all appropriate personnel
receive a copy of the revised QAPP or addendum once it is approved.
7.3. Acquired Data
As defined in Section 2 of this QMP, acquired data are data or information used for project
implementation or decision making which meet some or all of the following criteria:
Are compiled from other sources;
Were originally collected for some other purpose; and
Are obtained from non-measurement sources such as computer databases, programs,
literature files, and historical databases.
The use of acquired data must be addressed in each project-specific QAPP to include the
following information:
The type of data needed from non-measurement sources;
The acceptance criteria for their use;
A description of any limitations of such data; and
The individual(s) responsible for evaluating and qualifying the acquired data.
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The Project Manager is responsible for ensuring acquired data is addressed in a project-specific
QAPP. For those projects which involve the compiling and use of acquired data exclusively
(i.e., there will be no direct environmental data generation performed to accomplish the
project), a project-specific QAPP will still need to be prepared, reviewed, and approved as
described in Section 7.2.3 of this QMP. The Project Manager is responsible for
ensuring a QAPP is prepared for these types of environmental data projects. Because the
Region supports the use of the graded approach, the content of QAPPs for these types of
projects will vary and the standard QAPP format (as identified in the R-5 document) may need
to be modified to better meet the needs of these projects. Any such modifications to the R-5
requirements must be developed in cooperation with and approved by the RQAM.
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8. IMPLEMENTATION OF WORK PROCESS
The procedures described in this section on the implementation of work process must be
followed within all Divisions/Offices of Region 7. Within this Section, the implementation of
programs will be discussed through the use of the QMP and the QAARWP with the proper
levels of management participation and approval identified. Project implementation will also
be considered by focusing on the implementation of QAPPs, SOPs, and the Analytical
Methods Manual.
8.1. Program Implementation
The QMP will be reviewed annually by the RQAM, with assistance from the QA staff, to
determine if the information remains relevant to the Region. If changes are required, they
will be made in time to be reported to EQMD through the QAARWP. The on-line version of
the QMP will also be updated to include the changes. Every five years, based upon the
original approval date, the QMP will undergo a thorough review, in its entirety, and go
through the complete approval cycle. The QMP will also go through the complete approval
cycle anytime changes are made to the QMP that include major reorganization, significant
changes to the Region's mission, or other major changes to the Region's quality system.
Region 7 developed the QMP as a means of documenting how a Region 7 organization will
plan, implement, and evaluate the effectiveness of quality assurance and quality control
operations applied to environmental programs. All Divisions and Offices within Region 7 are
responsible for their implementation of the QMP. Quality System Audits, internal and
external MSRs (as defined in Section 2.2.1 of this QMP) will ensure that the Region 7 quality
system is being implemented as documented in this QMP.
The implementation of the Region 7's quality system will also be monitored through the
QAARWP. All EPA organizations conducting environmental programs that have a QMP
must submit an approved QAARWP to EQMD as required by the annual call letter and CIO
2105-P-01-0. The purpose of the QAARWP is to inform Agency senior management and
Region 7 senior management about the status and effectiveness of Region 7's quality system.
The QAARWP documents the findings of management's evaluation of Region 7's quality
system and the Region's performance during the immediate past fiscal year.
8.2. Project Implementation
Section 7.2.7 of this QMP discusses the implementation of QAPPs. Due to unforeseen
circumstances, changes in a QAPP and planned procedures may become necessary during the
project. Refer to Section 7.2.8 of this QMP for further details on how revisions to QAPPs are
handled. The Project Manager is responsible for verifying the changes were made as
described. This verification can be accomplished on an informal basis using routine on-site
surveillance or project status reports (or other project reports as required and identified in the
project-specific QAPP). The Project Manager can also use a more formal process like a TSA.
8.3. Standard Operating Procedures
Routine technical (except laboratory analytical methods) and administrative activities will be
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documented in SOPs to ensure consistency in the quality of the products and/or processes.
The SOPs will thoroughly describe steps and techniques, and will be sufficiently clear to be
readily understood by a person with knowledge in the general concept of the procedure or
process. The need for an SOP for a specific activity or operation can be identified by any
staff member in the Region, and can be written by any Regional staff member who is
knowledgeable of the activity, equipment, procedure or process to be addressed.
As a part of implementing the QAFAP requirements (aka, FOG), Region 7 has created eight
regional overarching SOPs which address how the Region will implement these guidelines.
These QAFAP SOPs have been incorporated into the Regional SOP system and are subject to
the same preparation, review, and approval process outlined in this section.
The QAFAP SOPs may also be supplemented with program specific procedure documents to
provide additional detail on program activities not included in an overarching QAFAP SOP.
Each program will be responsible for addressing how they will create, modify, review and
approve their documents at the program or division level. Program specific procedures,
guidelines, and checklists should also be controlled in a manner similar to the Regional
SOPs.
The primary guidance document for the preparation of SOPs is Region 7's SOP 1330.4,
Preparation of Standard Operating Procedures, current revision. The basis of the contents of
the SOP is the EQMD document entitled Guidance for the Preparation of Standard Operating
Procedures, EPA QA/G-6. The SOP outlines responsibilities, development, approval, and
filing of SOPs. Also, the specific elements to be addressed in both technical and
administrative type SOPs are included in the SOP. All Regional SOPs will be tracked and
maintained by the SOP Coordinator as outlined in Region 7 SOP 1340.3, Standard Operating
Procedures Tracking and Reporting System, current revision.
All SOPs will be approved, via signatures on the cover page, at a minimum by a peer
reviewer, the author's immediate supervisor, and the RQAM. All SOPs will be reviewed
every two years at which time the SOPs will be revised, recertified or archived (i.e., no
longer active). The SOPs will be accessible online by all Regional personnel via the Region
7@work intranet site. The QA Office will maintain signed versions of all Regional SOPs and
the archived SOP file.
8.3.1. Uses of SOPs
The use of SOPs is encouraged as a means of documenting routine or repetitious
activities, operations, and processes; of formally documenting routine actions; of
providing a reference that can be cited in QA documents; of promoting consistency in the
management of field practices across Regional programs to reduce potential
vulnerabilities; and for facilitating the consistency of procedures and processes which
will result in reliable data and results. The SOPs developed in Region 7 are accessible by
all Region 7 personnel. The Region's SOPs can be referenced in QAPPs and other
documents, as appropriate, in order to alleviate having to include descriptions of entire
processes or procedures that are routinely performed. Any limitations on the use or
applicability of an SOP will be included in the SOP itself.
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8.3.2. Implementation of SOPs
The implementation of SOPs is a responsibility that may cross organizational and
functional lines depending on the type of SOP (i.e., technical or administrative as defined
in Region 7 SOP 1330.4 Preparation of Standard Operating Procedures, current revision
and the situation involved. Generally, SOPs are implemented by personnel who perform
the activity or function to which the SOP pertains. It is normally the responsibility of the
applicable organization's manager to ensure that specific SOPs that pertain to the
organization's operations are implemented. It is normally the responsibility of the project
manager to ensure SOPs referenced in specific QAPPs are implemented. It is the
responsibility of the individual users of an SOP to follow the procedures contained in the
SOP, or to document any deviations. The implementation of SOPs will be assessed
through internal MSRs, TSAs or other oversight activities
8.4. Analytical Methods
Laboratory analytical methods will be documented using the Environmental Monitoring
Methods Council (EMMC) format and will be reviewed, approved, tracked, and maintained
similarly to SOPs as outlined in SOP 1330.4
Laboratory procedures that do not directly result in the generation of environmental data, but
which may or may not be related to a specific analytical method (e.g., glassware cleaning)
are called Standard Laboratory Operating Methods (SLOMS) and are reviewed, approved,
maintained, and tracked per SOP 1330.4.
8.4.1. Use of Analytical Methods
Generally, the analytical methods are for use by all LTAB analytical personnel and in-
house laboratory contractors. The analytical methods can be referenced in QAPPs and
other SOPs as appropriate. Any additional limitations on the use or applicability of a
method will be documented in the method itself.
8.4.2. Implementation of Analytical Methods
The LTAB Branch Manager and Section Chiefs are responsible for the implementation of
laboratory procedures and for ensuring all analyses are documented with an approved
LTAB method. Implementation of procedures will be ensured through LTAB internal
reviews according to Region 7 SOP 2430.6, Periodic Internal Program Review of the
Region 7 Laboratory, current revision and internal MSRs conducted by the QA Team as
described in Section 2.2.1 of this QMP.
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9. EVALUATION AND RESPONSE
It is Region 7's policy to evaluate the Region 7 quality system on a regular basis. The
mechanisms to be used for this evaluation are summarized below.
9.1. Annual Review of the Quality System and Quality Management Plan
The Region-wide quality assurance procedures described in the QMP will be assessed
annually and the QMP updated as necessary. The RQAM will be responsible for coordinating
this effort and ensuring that appropriate changes are incorporated into the QMP. Each
Division and Office Director will be responsible for ensuring that appropriate staff members
participate in the review of the Region-wide quality system. The Division and Office
Directors will review and approve significant changes to the QMP prior to their submittal to
EQMD. The annual review of the QMP and the quality system will be undertaken at the
same time as the development of the Region 7 QAARWP.
9.2. Audits
Internal and external audits will be the principal means for determining compliance with and
effectiveness of the quality system defined in the Region 7 QMP. Internal audits of Region 7
environmental programs are conducted by the Region 7 QA Office and technical staff
(usually on a division by division basis). Internal audits of activities subject to the QAFAP
requirements are conducted per the overarching QAFAP SOP 1750.01 Regional Field
Program Internal Audits and Corrective Actions, current revision.
External audits of the Region 7 quality system are conducted by EQMD, Office of Inspector
General auditors, or Headquarters' program office personnel. External audits of the Regional
Laboratory quality system are performed by the Region's NELAC Accrediting Authority per
the current NEL AC standards. Audits of Region 7 states, tribes and other external
organizations participating in the Region 7 quality system are performed by the Region 7 QA
Office. Internal and external audits should be conducted at a frequency sufficient to ensure
that appropriate quality assurance measures are being implemented. If auditing resources are
limited, environmental data collection programs or activities that are highly visible will be
given priority.
9.2.1. Quality System Audits (QSAs) and Management System Reviews (MSRs)
9.2.1.l.QSAs by EQMD
Quality system audits and MSRs evaluate a specific quality system to determine its
effectiveness and to identify areas where additional attention would bring significant
benefits. Quality system audits of Region 7 will be conducted by EQMD and MSRs
of R7 internal programs and external organizations will be conducted by the QA
Office. EQMD plans to implement independent QSAs of the Region 7 quality system
once every three years. Usually a review team of four members (two from EQMD
and two from other Regions) will spend a week in Region 7 meeting with
management, conducting personnel interviews, and performing file reviews. Results
are reported to the Region through a Draft Findings Report. The Region must respond
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to the results of the audit and develop a Corrective Action Plan to address any issues
which require corrective action. The roles and responsibilities of auditors, experience
and training for audit personnel, independence of audit personnel, and headquarters'
management review of and response to findings for QSAs conducted by EQMD are
established by the EQMD and are beyond the scope of this QMP. The QAARWP will
summarize the results of and response to any QSA conducted by the EQMD during
the previous fiscal year.
9.2.1.2.MSRs by the Region 7 QA Team
The RQAM will be responsible for MSRs of internal programs and external
organizations. All internal and external MSRs conducted by the Region 7 QA Office
will be performed as described in this section. The MSRs will be conducted by a
Region 7 review team with a minimum of two members according to the most current
version of Guidance for Preparing. Conducting, and Reporting the Results of
Management Systems Reviews. EPA QA/G-3 as modified by regional policy. MSRs
of both internal programs and external organizations will include a random sampling
of the projects for that program or organization (a list of the projects will be requested
from the program or organization as part of the MSR) to determine if the projects
were correctly identified as including environmental data generation and/or use and if
the QA requirements, including approved QAPPs prior to environmental data
generation and/or use, were applied and adequately addressed. MSRs will also
evaluate an organization's QAPP approval process which has been authorized by an
approved QMP and will be part of the MSR process as described in section 9.2.1.2 of
this QMP. Currently, this only applies to external MSRs because there is no QAPP
approval authority in place beyond the RQAM for internal organizations and
programs.
Modifications to the MSR process as described in the guidance are defined in the
MSR work plan templates and checklists developed by the QA Office and approved
by the RQAM. The team members will usually consist of permanently assigned staff
from the QA Office in order to ensure independence of the reviewers. Because
external MSRs are conducted by Region 7 QA Office personnel on organizations
external to Region 7, independence of the MSR team is ensured. If technical
assistance is needed for an external MSR, that assistance will be obtained through
Region 7 or from a different organization than the one being reviewed. Before a QA
Office member can be assigned to an MSR review team, they must have completed
the QA training required by this QMP for permanently assigned QA Staff (Section
3.2.3.4). The RQAM will assign the MSR review team members based upon the
internal program to be reviewed to ensure QA Staff with the appropriate experience,
competence, and technical knowledge are included on the MSR review team. The
RQAM may request assistance from other Regions or EQMD to supplement the
experience, competence, and technical knowledge of the MSR review team if needed
to accomplish a particular MSR. The review team will be expected to develop an
MSR work plan, to prepare notification and verification letters or memoranda
regarding the MSR, coordinate dates and times for the MSR meetings and interviews,
conduct the MSR, and prepare the MSR report. Typically, a review team leader will
be designated by the RQAM to coordinate the MSR effort with the other review team
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members and the reviewed organization or program.
The MSRs will consist of meetings with the management of the reviewed
organization or program, interviews with personnel, and file reviews. The verification
letter or memorandum is a follow up to the initial notification letter to verify the
dates, times, and location for the MSR. The verification letter will also inform the
reviewed organization or program of the programs, personnel, documents, and
records to be addressed by the MSR to ensure the review team will have the required
access to complete the evaluation. Because the Regional Administrator has directed
the RQAM to conduct internal MSRs and the QA Office is centrally located within
ENST, the review team will have sufficient authority and organizational freedom to
identify quality problems and noteworthy practices, propose recommendations, and
independently confirm implementation and effectiveness of solutions.
Results of the MSR will be reported to management through a Draft Findings Report.
The reviewed organization or program will be given the opportunity to respond to the
Draft Findings Report and to develop a Corrective Action Plan to address any issues
identified as requiring corrective action. The Corrective Action Plan must identify the
corrective action, responsible official(s), and the projected completion date for each
finding requiring corrective action. The RQAM will review the Corrective Action
Plan and prepare any necessary responses for discussion with the management of the
reviewed organization or program. Once any outstanding issues have been addressed
and the corrective actions agreed upon by the RQAM and the reviewed organization's
or program's management, a Final Report will be issued. The confirmation and
implementation of the corrective actions will be done through the submittal of
associated documents (e.g., a revised QMP) to the RQAM for review or through a
follow-up evaluation. The QAARWP will identify the MSRs of internal programs or
external organizations planned for the upcoming fiscal year.
9.2.2. Annual Program Reviews
The QA Office will participate in annual program reviews as requested by the applicable
Region 7 Program Coordinator for each state or tribe (State Coordinator). These reviews
will follow the same process as an MSR conducted by the QA Office (as described in
Section 9.2.1.2 of this QMP) with modifications made as necessary to meet the particular
needs of the program being reviewed and the State Coordinator. The QAARWP will
identify participation by the QA Team in annual program reviews for the upcoming fiscal
year, if the information is available at the time the QAARWP is prepared.
9.2.3. Technical Systems Audits
Technical systems audits are a thorough, systematic, on site, qualitative audit of facilities,
equipment, personnel, training, procedures, recordkeeping, data validation, data
management, and reporting aspects of field and laboratory activities. Project-level
documents, such as a QAPP, will specify the need for a TSA for a particular project. The
Project Manager is responsible for ensuring the specified TSA is accomplished.
Although a project manager will be responsible for ensuring any planned TSA is
accomplished, under no circumstances will a project manager ever be responsible for
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auditing his/her own work. For most projects in Region 7, the work for a project is
actually being performed by a contractor, a facility, the facility's consultant, a grantee, or
some other party and the Project Manager provides oversight. For example, many RCRA
Project Managers will contract with USGS to perform oversight and split sampling
activities as part of technical oversight of a facility and/or their consultant.
The QA Office will perform a TSA or otherwise provide assistance for a TSA in a
situation where the Project Manager is responsible for actually performing the work. A
TSA can be conducted with the assistance from the QA Office as requested. The
QAARWP will identify any other TSAs planned for the upcoming fiscal year. The most
current version of the document Guidance on Technical Audits and Related Assessments
for Environmental Data Operations. EPA QA/G-7, can be used to assist with the conduct
of a TSA.
The individual(s) conducting the TSA should, at a minimum, have completed the QA
training courses as required in this QMP (or their functional equivalent). The roles,
responsibilities, and independence of the evaluation personnel, the process for reviewing,
reporting and responding to corrective actions, and the process for ensuring the
implementation and effectiveness of corrective actions can vary among projects;
therefore, these details will be defined in a QAPP. During QAPP reviews, the QA Office
will ensure that the process described in a QAPP for a TSA covers the completion of
assessment reports in a timely manner including appropriate levels of review and
approval as well as how and when corrective actions are to be taken in response to the
findings.
9.2.4. Other Technical Audits
Other types of technical audits can include, but not be limited to: readiness reviews,
surveillance, and audits of data quality. Project-level documents, such as a QAPP, will
specify the need for these types of technical audits for a particular project. During QAPP
reviews, the QA Office will ensure that the process described in a QAPP for technical
audits covers the completion of assessment reports in a timely manner including
appropriate levels of review and approval as well as how and when corrective actions are
to be taken in response to the findings. The Project Manager is responsible for ensuring
the specified technical audit is accomplished. These technical audits can be conducted
with the assistance from the QA Team as requested. The QAARWP will identify any
other technical audits planned for the upcoming fiscal year. The most current version of
the document Guidance on Technical Audits and Related Assessments for Environmental
Data Operations. EPA QA/G-7, can be used to assist with the conduct of these other
technical audits.
Audits for activities subject to the QAFAP requirements will be routinely conducted as
defined in the QAFAP overarching SOP 1750.01 Regional Field Program Internal Audits
and Corrective Audits, current revision. Personnel conducting the audits will be required
to have completed QAFAP auditor training, be familiar with and understand the QAFAP
requirements, and at least one member of the audit team will have field experience.
QAFAP audits will be coordinated through the Regional QA Office which will ensure
audit personnel have the freedom to conduct the audit and the needed access to records
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and personnel. To ensure independence, the QAFAP audit team will be made up of
personnel from a program other than the one being audited.
9.2.5. Response Actions
Senior management is responsible for determining necessary actions and developing a
plan to address weaknesses disclosed in any audit. Milestones will be developed so that
progress on corrective actions can be measured. This information will be included in the
audit file, which is to be maintained by the RQAM. Regional managers are responsible
for ensuring compliance with the approved corrective actions. Progress is to be reported
to the Regional Administrator, Division and Office Directors, and the Regional Federal
Managers' Financial Integrity Act Coordinator. This will include identifying any
problems in audits discussing corrective actions and summarizing follow-ups on the
previous year's agenda. If major deficiencies are found, follow-up audits may be required
and should be discussed with senior management.
9.2.6. Data Quality Assessments
A data quality assessment (DQA) is the scientific and statistical 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 use of the DQA process will be
specified in project-level documents such as a QAPP. The most current version of EPA's
DQA guidance (QA/G-9R and G-9S) can be used to assist in the DQA process. Data
quality assessments are the responsibility of the Project Managers and the level of effort
for the DQA will be commensurate with the project objectives and intended use of the
data. An individual(s) conducting DQAs should, at a minimum, have completed the DQA
training course and associated prerequisites required by this QMP (or their functional
equivalent). The QA Office will provide technical assistance as requested. If assistance is
requested from the QA Office, the Project Manager will ensure the QA Office has access
to all project documents and records needed to complete a DQA. The results of the DQA
will be documented and provided to the Project Manager. The Project Manager will then
be responsible for reviewing the results, determining if and what corrective actions are
needed, for confirming implementation and effectiveness of corrective actions, and
determining final usability of the data in alignment with project objectives and decisions.
9.2.7. Performance Evaluations
A performance evaluation, also known as a performance test sample, is a type of audit
where samples of known concentration are analyzed by a laboratory to evaluate the
proficiency of an analyst or laboratory. Performance evaluations programs are developed
as a tool to help ensure the quality of the Agency's and Region 7's environmental data
collection activities. Performance evaluation programs are important because
environmental data are used as a basis for regulatory and guidance development and for
compliance evaluation across the Agency. Performance evaluations are strongly
supported and should be used by the Region, States, and local agencies.
Because performance evaluations are project-level evaluations, their use will be specified
in a project's QAPP. It is the responsibility of the Project Manager to determine the
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applicability of performance evaluations for a project and to ensure they are
accomplished as defined in QAPPs. The Project Manager will also be responsible for
reviewing the results of performance evaluations, determining corrective actions, and
confirming the implementation and effectiveness of corrective actions.
Region 7 ENST may periodically incorporate performance evaluation samples into
analytical activities managed by ENST regardless of where the analyses are performed
and a Region 7 Project Manager may also request performance evaluation samples. The
performance evaluation samples are then submitted "blind" to the laboratory being
evaluated. Each request must go thru the Laboratory Director and will be managed on a
case-by-case basis.
Performance evaluation of the Regional Laboratory is addressed in Region 7 SOP
2430.11, Region 7 Laboratory Participation in Proficiency Testing Studies, current
revision.
9.2.8. Dispute Resolution
If disputes are encountered as a result of evaluations, the dispute resolution process as
defined in Section 1.9 of this QMP shall apply.
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10. QUALITY IMPROVEMENT
It is Region 7 policy that quality assurance be a critical component of all the work functions
within our programs. The intent of this QMP is to provide the basis for integrating appropriate
quality assurance activities into the full cycle of Region 7 programs from the planning phases
through the evaluation phases. If the principles outlined in the QMP are followed, problems
can be detected in a timely manner, before programmatic and financial issues become critical
and hinder program implementation and decision making.
Within Region 7, there are several levels of review that will help uncover problems with the
quality system.
10.1. Internal Region 7-Wide Reviews
Each year the quality system and QMP will be reviewed by Region 7 staff and management
as part of the QAARWP development process to ensure that the QMP is still relevant to the
Region 7 mission. It will be the responsibility of the RQAM to coordinate the review. The
QMP will be modified to reflect changing needs or additional guidance as needed.
The RQAM meets with each program office staff as necessary. A key purpose of these
meetings is to identify quality assurance issues of concern. Based on consultations with
senior management, the RQAM will initiate MSRs or special projects to address and correct
quality assurance problems identified by staff input. The RQAM will also respond to requests
from management to address specific quality assurance problems of significance to the entire
office. Actions developed to correct any major quality assurance deficiencies will be
documented in the QAARWP and reviewed and approved by the appropriate Division/Office
Director and the Regional Administrator. See Section 8.1 of this QMP for more details
regarding the review and revision of the QMP and the preparation of the QAARWP.
10.2. SOP Reviews
At least every two years each Region 7 SOP will be reviewed to determine if they remain
relevant to the mission of the program and properly describe the procedures used to obtain
data of known and sufficient quality to support programmatic decisions. Ensuring that this
review occurs is the responsibility of Supervisors and/or Division/Office Directors
responsible for implementing the program. Actions will be developed by Supervisors or their
designee to correct any major quality assurance deficiencies. The QAARWP should also
describe any progress in quality assurance implementation. See Sections 8.3 and 8.4 of this
QMP for more details regarding the maintenance of the Regional SOP system and analytical
methods, respectively.
10.3. Program Reviews
Program reviews, as described in Section 9.2.2 of this QMP, and internal MSRs, as described
in Section 9.2.1.2 of this QMP, are conducted with the intent to look for opportunities for
improving the quality system at either the state and tribal or Regional Office level,
respectively. The program reviews and internal MSRs will be utilized as a means of
evaluating implementation and effectiveness of quality systems.
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10.4. Project Reviews
It is Region 7's policy that the Project Manager, with assistance from the RQAM and project
participants, will review project implementation at regular intervals to identify where
improvements in data quality can occur. Project reviews can consist of:
Technical System Audits;
Data Quality Assessments;
Peer reviews;
Conference calls; and
Meetings.
Generally, there should be a meeting at the end of the data collection phase of a project. If
results from preliminary DQAs are available for this meeting, participants can use the
information to determine whether a QAPP was followed and that quality was controlled to an
acceptable level. The SOPs should be revised to reflect changes and improvements in
procedures that were developed during the program. Weaknesses, problems, and
recommended corrective actions for future programs should be documented in the quality
assurance section of the final project report.
10.5. Quality Improvement Responsibilities
Region 7 staff, at all levels, is accountable for continuous quality improvement. The process
of continuous quality improvement leads to a better and more responsive quality system. In
order to minimize, prevent, detect, and promptly correct problems related to the quality
system, the Region has implemented the evaluation approach as described in Chapters 8 and
9 of this QMP. Because the supervisors, Project Managers, and other technical staff are
responsible for the day-to-day operations, they typically have the most direct experience with
the quality system process and are encouraged to identify opportunities for improving the
quality system by contacting the RQAM directly or through discussion with their
management. During interviews conducted by the Region 7 QA Office during the MSR
process, the review team includes questions regarding the support received by personnel
from the QA Office in an effort to encourage open dialogue on how the quality system can be
improved to help Regional staff perform their job functions. Another process by which the
QA Office actively encourages input on the quality system from Regional personnel is
through the evaluation forms provided during each QA training course. After completion of
the course, attendees complete an evaluation form which is used to evaluate the training
program and to identify future training needs. The entire QA Office is given the opportunity
to review the evaluation forms and QA training meetings are held regularly to discuss and
address critical issues identified through these evaluation forms. The QA Refresher also
offers staff an opportunity to provide their input and suggestions about the quality system.
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ATTACHMENT A
Region 7 Organization Chart with QA Lines of Authority and Communication
OFFICE OF
REGIONAL
COUNSEL (CNSL)
REGIONAL
ADMINISTRATOR
(RGAD)
OFFICE OF
PUBLIC AFFAIRS
(OPA)
OFFICE OF
TRIBAL AFFAIRS
(OTA)
ENFORCEMENT
COORDINATION
OFFICE (ECO)
ENVIRONMENTAL
SCIENCES AND
TECHNOLOGY
DIVISION (ENST)
Regional QA
Manager and QA
Office
AIR AND WASTE
MANAGEMENT
DIVISION (AWMD)
SUPERFUND
DIVISION (SUPR)
WATER,
WETLANDS AND
PESTICIDES
DIVISION (WWPD)
OFFICE OF
POLICY AND
MANAGEMENT
(PLMG)
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ATTACHMENT B
Quality Assurance Review Form
Title: Region 7 2016 QMP
Revision: 0
Date: December 2016
Page 58 of 68
Contracts Management Manual April 7, 2004
APPENDIX 46.ID U.S. EI'A QUALITY ASSURANCE REVIEW FORM
FOR CONTRACT ACTIONS
I. General Information
a. Vehicle Type:
| J Solicitation/Sole Source (RFP #: )
[ ] Delivery Order/Work Assignment /Task Order
(SOW if- and Contract U: _
1». Descriptive Tide:
c. Sponsoring Organization {e.g., Branch, Division, Office, etc J;
d. Project Duration:
e. Is this a new f J or continuation of an existing | J project?
II S co |J e o f W o rk
/For example etetiviths, set' www.epa-gov/qualiiy/examples.htmJJ
a. Dots the work involve: Yes No
the collection, generation, use and/or reporting of environmental datu? | ] [J
(Environmental data arc defined as any measurements or information that
describe environmental processes, location, or conditions; ecological or
health efleets und consequences; or the performance of environmental
technology. Foi CPA, environmental data include information collected
directly from measurements, produced from models, and compiled from
other sources such as data bases or the literature.)
design, construction, and/or operation of environmental technologies?
development and/or use of models?
- other activities that need quality assurance or quality control
requirements as identified in your organization's Quality Management
Plan? If yes, list:
IJ nil answers arc Na, skip Sect inn III and cmttplclc AVcthtn 1\,
b- listtmate. of percentage of cost;, or level-ol-elTort allocated to the activities identified above;
%.
Ill]
MM
MM
CoiUtv.GLs Management Manual
Section 46,1
P% 11
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Title: Region 7 2016 QMP
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April 7, 2004
HI. Quality-Related Requirements
[Where applicable, reference a specific section of the Statement of Work.]
a, For Solicitations Only [complete (b) - (/) below, as we//]
S. Insert the percentage of technical evaluation points assigned to offeror's quality
system documentation, or P/P if the evaluation is pass/fail:
2, List any quality standards (from your organization's Quality Management Plan)
that you will use in lieu of, or in addition to. Spec ijications and Guidelines for
Quality Sv,stems for Environmental Dot it i "oilection and Environmental
Technology Programs (ANSl/ASQC F4j. These standards arc
Title: _____
Numbering:
Date:
Requirements (Tailoring):
b. QA Documentation Options: [For wlicitaliiUts, complete items 1-4: for all actions
other than solicitations, complete items 5-4 All documentittion specified water "Oilier"
in f is I he defined in your organization Qua!it) Management Plan ami he consistent with
requirements defined in EPA Monthtl S360 A I, For items cheeked under H2, there must
he adequate information in the SOU far the offeror c> develop this documentation.]
Before Award Documentation'
1. Documentation of an organization's Quality System* Hither O QMP
developed in accordance with R-2 ui U Other:
Combined documentation of an organization's Quality System and
application of QA and QC to the .single project covered by contract;
Either developed in accordance with ~ R-2 and R-5 or ~ Other:
2. Programmatic QA Project Plan: Either developed in accordance with R5
or ~ Other:
' 'I- i ,i '.}uaiiry K.iti.rs-r..-- u< £ . .4; i. -'t c;r cij. .itat 1 c v,'1 i r.^ec' ; ',.11
1 - - - 1 t.o '4 U.T\ li.i'v rf ;- 1 '-ji
~if"' ' * !x-*' r v - to yt'A ! -ytni r pm^n" a tor (I'.ji,, v 'an.if.m^nt F ^an.
,"b-2) iEPA/4h-OiYY , n iii) -1. guv/qu- ' " , y ,
Contracts Management Manual Section 46,1 Page 12
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Contracts Management Manual April 7, 2004
Application of QA and QC activities to the single project covered by
contract: Either ~ QA Project Plan developed in accordance with R-5 or
~ Other:
Not applicable.
After Award Documentation1
3. _ Documentation of an organization's Quality System: Either ~ QMP
developed in accordance with R-2 or ~ Other:
Combined documentation of an organization's Quality System and
application of QA and QC to the single project covered by the eon:ract:
Either developed in accordance with ~ R-2 and R-5 or ~ Other:
Not applicable,
4. Documentation of the application of QA and QC activities to applicable
projeet(s): Either developed in accordance with ~ R-5: ~ A .supplement
to the following Programmatic QA Project Plan ; or
~ Other:
Programmatic QA Project Plan with supplements for each specific
project: Developed in accordance with:
Existing documentation of the application of QA and QC activities will be
used: Either ~ Documentation developed pre-award: ~ Documentation
will be identified in individual Statements of Work or ~ Documentation
identified in Section of the Statement of Work,
c. Reports: Are quality reports or reports containing quality assurance in torn Kit ion (for
example, status of quality system implementation, review of a quality system, quality
control data, etc.) required? | ] Yes [ ] No
[f yes, identify the required reports and the time frame for submission:
d. Assessments; Select all quality assessments that will be performed either pre-award or
post-award:
Pre-
Award
Post-
Award
On-site evaluation of offerors/contraetors facility
Assessments of the offerer's/contractor's Quality System (e.g.,
quality system audits, management system reviews, etc.)
Contracts Management Manual
Section 46.1
Page 13
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Title: Region 7 2016 QMP
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Page 61 of 68
April 7, 2004
Project-specific assessments (e.g., technical systems audits,
surveillance, performance evaluations, data qualify assessments.
peer reviews, readiness reviews)
For each assessment, specify type, date to perform, and who will perform it (if known):
e. Procedures to Update Documentation: Identify any procedures/requirements for
updating EPA-approved quality-related documentation:
f. Other Requirements: Identify any other pertinent quality-related requirements (as
identified in your organization's Quality Management Plan):
IV. The signatures below verify that the Statement of Work has been reviewed to ascertain if
quality assurance or quality control activities are needed and that the appropriate qualify
requirements have been established.
Contracting Officer's Representative Date Quality Assurance Manager Date
Contracts Management Manual Section 46.1 Page 14
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ATTACHMENT C
STANDARD FORM 424
Title: Region 7 2016 QMP
Revision: 0
Date: December 2016
Page 62 of 68
APPLICATION FOR
FEDERAL ASSISTANCE
2. DATE SUBMITTED
Applicant Identifier
1. TYPE OF SUBMISSION
Application
~ Construction
~ Non-Construction
Preapplication
~ Construction
~ Non-Construction
3. DATE RECEIVED BY
STATE
State Application Identifier
4. DATE RECEIVED BY
FEDERAL AGENCY
Federal Identifier
5. APPLICANT INFORMATION
Legal Name:
Organizational Unit:
Address (give city, county, state, and zip code):
Name and telephone number of the person to be contacted on matters involving
this application (give area code)
6. EMPLOYER IDENTIFICATION (EIN):
TYPE OF APPLICANT: (enter appropriate letter here)
8. TYPE OF APPLICATION:
~ New ~ Continuation
~ Revision
If Revision, enter appropriate letter(s) in box(es):
~ ~
A. State H. Independent School District
B. County !. State Controlled Institution of Higher Learning
C. Municipal J. Private University
D. Township K. Indian Tribe
E. Interstate L. Individual
F. Intermunicipal M. Profit Organization
G. Special District N. Other (Specify):
A. Increase Award
C. Increase Duration
Other Specify:
B. Decrease Award
D. Decrease Duration
9. NAME OF FEDERAL AGENCY:
10. CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER:
11. DESCRIPTIVE TITLE OF APPLICANT'S PROJECT:
~ ~
~ ~ ~
12. AREAS AFFECTED BY PROJECT (cities, counties, states, etc.):
13. PROPOSED PROJECT:
14. CONGRESSIONAL
DISTRICT OF:
Start Date
End Date
a. Applicant:
b. Project
15. Estimated Funding:
16. IS APPLICATION SUBJECT TO REVIEW BY STATE EXECUTIVE
ORDER
12372 PROCESS?
a, YES. THIS PREAPPLICATION/APPLICATION WAS MADE AVAILABLE
TO THE STATE EXECUTIVE ORDER 12372 PROCESSES FOR
REVIEW ON:
DATE
a. Federal
$
b. Applicant
$
c. State
$
d. Local
$
b. NO. ~ PROGRAM IS NOT COVERED BY E.O. 12372
~ OR PROGRAM HAS NOT BEEN SELECTED BY STATE FOR
REVIEW
e. Other
$
f. Program Income
$
17. IS THE APPLICANT DELINQUENT ON ANY FEDERAL DEBT?
~ YES If "Yes" attach an explanation. ~ NO
g. TOTAL
$
18. TO THE BEST OF MY KNOWLEDGE A
ND BELIEF, ALL DATA IN THIS APPLICATION/PREAPPLICATION ARE TRUE AND CORRECT, THE
DOCUMENT HAS BEEN DULY AUTHORIZED BY THE GOVERNING BODY OF THE APPLICANT AND THE APPLICANT WILL COMPLY WITH THE
ATTACHED ASSURANCES IF THE ASSISTANCE IS AWARDED.
a. Typed Name of Authorized Representative.
b. Title:
c. Telephone Number
d. Signature of Authorized Representative
e. Date Signed
Previous Editions Not Usable AUTHORIZED FOR LOCAL REPRODUCTION Standard Form 424 (REV 7-97)
Prescribed by OMB Circular A-102
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ATTACHMENT D
PROGRAMMATIC CERTIFICATION
AUTHORIZATION TO AWARD AN ASSISTANCE AGREEMENT
PROGRAMMATIC CERTIFICATION
Authorization to Award an Assistance Agreement'
(Instructions for Completing this form are on the Reverse Side)
ASSISTANCE NUMBER
ASSISTANCE RECIPIENT NAME
DELEGATION
NUMBER
PROGRAM
CODE
STATUTORY AUTHORITY
ACT:
SECTION:
APPROVED PROJECT PERIOD
START
END
PROGRAM/PROJECT TITLE AND DESCRIPTION:
RECOMMENDED FUNDING: The proposed budget included In (he Application for Federal Assistance, (which includes the Recipient and
Federal share ol funds) has been reviewed lor eligibility and reasonableness of costs related to program activities contained in the nvrkplan.
I recommend funding as indicated below and have attached a Commitment Notice (EPA Form 2550-9) to obligate these funds:
TOTAL APPROVED» PROGRAM/ PROJECT COSTS? FEDERAL FUNDS?
OTHER REQUIREMENTS
QUALITY ASSURANCE This grant/cooperative agreement includes activities that require the preparation
and approval of Duality Assurance documents. If YES, please indicate the following:
The workpian adequately addresses OA requirements including preparation, review and approval of QA
documents. If NO, please attach the required QA condition to the award.
COMPETITION This application was competed. If no, please attach the rationale for the decision to award
this application non-competitiveiy.
PEER REVIEW IS REQUIRED FOR THIS AWARD.
PROGRAMMATIC TERMS AND CONDITIONS OF AWARD ARE REQUIRED (attach conditions)
THIS IS A COOPERATIVE AGREEMENT.
YES
NO
~ ~
~ ~
~ ~
~ ~
~ ~
CrHTIFICAIION; ihoappr
reviewed
Li fiction with
IS
review
ax ro:;
EPA PROJECT OFFICER
r
PRINTED NAME
TITLE
DIV/BRANCH/SECTION | EXTENSION
RECOMMENDING OFFICIAL
SIGNATURE & PRINTED NAME
TITLE
DATE
DECISION OFFICIAL (or their designee)
S1GNA1 UHE & rHINTED NAME
TITLE
DATE
Grant Management Specialist: * 7-y^,
*7 G*0 04/98
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ATTACHMENT E
QUALITY ASSURANCE REQUIREMENT FORM
¦s A \ quality assurance
I ? REQUIREMENT FORM
9 J? 40 CFR 30.54 and 31.45
^ PRO"*^°
If your program/project involves environmentally related measurements or data genera-
tion, you are required to develop and implement quality assurance practices. Please
complete this form in its entirety and return it with the Application for Federal Assis-
tance, SF-424.
YES NO
~
~
~
~
The workplan, which is submitted with the Application for
Federal Assistance, includes environmental sampling
or data generation.
A Quality Management Plan was previously reviewed and
approved by the U.S. EPA and is still current and applicable.
Please note that prior to environmental sampling or data generation, a site
specific Quality Assurance Project Plan must be prepared and approved. For
additional information concerning quality assurance, please contact the R7
Quality Assurance Manager at (913^ 551-5000
Date Applicant Signature
Applicant Title
Applicant Organization
ENSV Revised 03/97
1-1
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ATTACHMENT F
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
pollution prevention, pollutant reduction, or containment of contamination to prevent further
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movement of the contaminants, such as capping, solidification or vitrification, and biological
treatment.
Exportable standard operating procedures - technical SOPs which address techniques or
processes which can be used by and distributed to other agencies, organizations, or individuals
outside of Region 7 or the Agency. These SOPs will typically focus on environmental data
generation, use or data quality.
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.
Intramural standard operating procedures - administrative SOPs (desk top procedures) which are
Region-specific and can be either common across the Region or can be division-specific. These
SOPs are not available for use to others outside the Region 7.
Management - those individuals directly responsible and accountable for planning,
implementing, and assessing work.
Management system - a structured, non-technical system describing the policies, objectives,
principles, organizational authority, responsibilities, accountability, and implementation plan of
an organization for conducting work and producing items and services.
Management systems review (MSR) - the qualitative evaluation of a data collection operation
and/or organization(s) to establish whether the prevailing quality management structure, policies,
practices, and procedures are adequate for ensuring that the type and quality of data needed are
obtained.
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
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pertaining to specific work and of the documentation that supports them.
Performance evaluation - 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.
Quality assurance (OA) - 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,
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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 and for carrying out required
QA and QC activities.
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.
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.
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 systems audit (TSA) - a thorough, systematic, on-site, qualitative audit of facilities,
equipment, personnel, training, procedures, record keeping, data validation, data management,
and reporting aspects of a system.
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