REGION IX
QUALITY MANAGEMENT PLAN
U.S. Environmental Protection Agency
Region IX
75 Hawthorne Street
S an F ranci scoCA94105
Document Control Number
MISC0185PV3
September 1, 2020
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PAGE INTENTIONALLY LEFT BLANK
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UK P. PA RRilON Y MANAt iPMPN !' PLAN
September 1.2Q2l)
Rl*(il( )N lH'C >NCrRR!-:NCK:
mUM D I ICTCDI in Digitally signed by JOHN BUSTERUD
JUiiN DUb I tKUU Date: 2020,09,05 13:42:12 -07*00'
John W. Huston id Dale
Regional Administrator
nCRnDALI inDnAKI Digitally signed by DEBORAH JORDAN
UlLDUKAm JUKUAN Date: 2020.09.06 09:03:51 -0700"
Deborah Jordan Date
Deputy Regional Administrator
m lAWF I A M FQ Digitally signed by PUANE JAMES
L/UMM L_ JMlVlLJ Date: 2020.09.0409:15:17 -07*00"
Duane James, Director Date
Lab Services and Applied Science Division
Digitally signed by Audrey L Johnson
Audrey L Johnson
Date: 2020.09.0210:03:52 -0700'
Audrey L, Johnson, Manager Dale
Quality Assurance Branch
OM-lt'H or MISSION STPPORi rONlVRRLNCl-;
\/A| irUM kl flf* A Digitally signed by VAUGHN MOGA
VAUUnil INUOA Date: 2020.09,0910:21:13 -04*00'
Yauuhn Noga. Chid'Information < M'Heer and Dale
Deputy Assistant Administrator for I m ironmenUii Information.
C H'ilcc of Mission Support
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Contents
EXECUTIVE SUMMARY 7
FOREWORD 8
1.0 Quality System Foundation 8
1.1 Regional Quality Assurance Goals and Policies 8
1.1.1 Quality Assurance Basic Goals 9
1.1.2 Quality Assurance Policies 9
2.0 Regi on 9 Organizati on 10
2.1 Regi onal Admini strator 10
2.2 Laboratory Services & Applied Science Division Director /Scientific Integrity Officer
2.3 Senior Management 11
2.4 Regional QA Manager 11
2.4.1 Mandatory Independence of the Regional Quality Assurance Branch 12
2.5 Quality Assurance Branch 12
2.6 Regional Organizations with QA responsibilities 13
2.6.1 Air and Radiation Division 13
2.6.2 Enforcement and Compliance Assurance Division 14
2.6.3. Laboratory Services and Applied Science Division 14
2.6.4. Land, Chemicals and Redevelopment Division 15
2.6.5 Mission Support Division 15
2.6.6 Office of Public Affairs 15
2.6.7 Office of Regional Counsel 16
2.6.8 Superfund and Emergency Management Division 16
2.6.9 Tribal, Intergovernmental and Policy Division 17
2.6.10 Water Division 17
3.0 Regional Quality System 17
3.1 Overview 17
3.1.1 The Graded Approach 17
3.2 System Level Planning 18
3.3 Program Level Planning 18
3.3.1 Graded Approach at the Organization or Program Level 18
3.4 Project Level Planning 19
3.4.1 Scoping Meetings 19
3.4.2 Setting Project Data Quality Objectives 19
3.4.3 Graded Approach at the Proj ect Level 20
3.5 Q A Annual PI anning 20
3.5.1 Regional QA Planning Process 20
3.5.2 National QA Planning Process 20
3.5.3 QA Office Planning Process 21
3.6 Planning Documentation 21
3.6.1 Policies 21
3.6.2 Types of QA Planning Documents 21
3.6.3 Revi ew and Approval of Q A PI anning Documents 23
3.6.4 Quality Assurance Guidance Documents 23
4.0 Implementation 23
4.1 Overview 23
4.2 Document Review 23
4.2.1 Quality Assurance Branch Review Process 23
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4.2.2 Other Document Review 24
4.3 Training 24
4.3.1 Quality Assurance Branch Staff Competency 25
4.3.2 In-House and External Training 25
4.4 Procurement of Items and Services 26
4.4.1 Procurement Activities 26
4.4.2 Contracts Involving Environmental Measurements 26
4.4.3 Grants and Financial Assistance Agreements 27
4.4.4 Interagency Agreements 28
4.5 Quality Documentation and Records 28
4.5.1 Regional Records Management System 28
4.5.2 Quality Assurance Documentation and Records 28
4.5.3 Quality Assurance Guidance Documents 29
4.6 Computer Hardware and Software 30
4.6.1 Regional Information Resources Management Policies 30
4.6.2 Standards for Computer Generated Data 31
4.6.3 Regional Environmental Data Storage and Retrieval 31
4.6.4 Geographic Information Systems 31
4.7 Lab oratory Program 32
4.7.1 Mission 32
4.7.2 Facilities 32
4.7.3 Delivery of Laboratory Services 32
4.7.4 Laboratory Quality Assurance Organization 33
4.7.5 Laboratory Quality Assurance System 33
4.8 Field Operations 33
4.8.1 Organization, Roles and Responsibilities 34
4.9 Standard Operating Procedures 35
4.10 Measurement Quality Objectives/Data Quality Indicators Tables 36
4.11 Information Quality Guidelines 36
4.12 Peer Review 37
5.0 Assessment 37
5.1 Overview 37
5.2 Assessment Tools 39
5.2.1 Quality System Reviews (QSRs) 39
5.2.2 Technical Systems Audits (TSAs) 39
5.2.3 Performance Evaluation Samples (PEs) 40
5.2.4 Data Review: Verification and Validation 41
6.0 Quality Improvement 42
6.1 Planning documents 42
6.2 Training 42
6.3 Audits 43
6.4 Standard Operating Procedures 43
This Page Intentionally Left Blank 44
APPENDIX A: Quality Assurance Branch Staff Qualifications 45
APPENDIX B: Organization of the Laboratory Services and Applied Science Division 47
APPENDIX C: Region 9 Organization 49
APPENDIX D: Navajo Abandoned Uranium Mine QMP 51
CONCURRENCES AM) APPROVALS iv
PURPOSE AM) BACKGROUND 1
Introduction 1
iv
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Definition of the Problem and Background Information 4
Program Description 4
Tribal Land Cleanup and Remedial Support Branch Manager 7
Project Manager 7
Quality Assurance Branch 8
Data Management Team 8
Office of Radiation and Indoor Air 8
Office of Land and Emergency Response 9
Partner Agencies 9
NAUM Standard Quality Practices 11
Review and Approval of QAPPs 11
Field Oversight Tools and Considerations 15
Validation of Data 15
Laboratory Competency 17
Continuous Quality Improvement 17
Deterrence of Fraud 18
Quality Objectives and Criteria for Measurement Data 19
DATA GENERATION AM) ACQUISITION 20
Sampling Process Design 20
Data Quality Objectives 20
Data Quality Indicators 20
Measurement Quality Objectives 22
Field Sample Collection Methods 24
Laboratory Analytical Methods 25
Quality Control Requirements 25
Field Sampling Quality Control 25
Laboratory Quality Control 25
Instrument and Equipment Testing, Inspection, Maintenance 26
Instrument and Equipment Calibrations and Frequency 26
Gamma Scanning Field Measurements 27
Non-Direct Measurements 27
Gamma Data Validation Considerations 27
ASSESSMENT AM) OVERSIGHT 37
NAUM program oversight efforts 37
Assessment and Response Actions 37
Audits 37
Nonconformance and Corrective Actions 38
Reconciliation of Data with Data Quality Objectives 38
Field Oversight 39
Types of Field Oversight Activities 39
Field Oversight Goal 40
Field Oversight Responsibilities 42
Field Oversight Tools and Considerations 44
Resources for Planning and Implementing Field Oversight 44
Reports to the Project Manager 46
DATA VALIDATION AM) USABILITY 46
Data Review and Validation 46
Data Review and Validation Procedure 46
Data Usability Assessment 47
RELEVANT PROGRAM GUIDANCE 49
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REFERENCES
ACRONYMS AND ABBREVIATIONS
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EXECUTIVE SUMMARY
USEPA requires that all Programs, Laboratories and Regions operate within a quality
management system that specifically addresses the collection, production or use of
environmental data. This commitment to a quality system ensures that Agency decisions are
made with data of known quality and are presented with the confidence that they are credible and
defensible. Each Program and Region has a Quality Management Plan (QMP) that describes its
commitment to and support of its quality system. The QMP is intended to be useful internally to
inform Region management and staff, and externally as a model for state, tribal and local
agencies and contractors receiving EPA funds to perform environmental data collection.
The Quality Assurance Branch reviews and revises the QMP every five years. The QMP is
submitted to the Office of Mission Support (OMS), Environmental Information (EI), Office of
Enterprise Information Program (OEIP), Enterprise Quality Management Division (EQMD) for
review and suggested revisions.
The Region 9 QMP reflects the Agency's decision in 2018 to realign EPA's regional
organizational structure, to increase visibility into regional office operations; improve the
consistent implementation of EPA regulations and policies; allow for better resource allocation;
enhance operational excellence; and provide for greater transparency for EPA's customers. The
QMP also includes Region 9's commitment to collect and use data of known and appropriate
quality to support decision making, including the Information Quality Guidelines (Region 9 Pre-
Dissemination Review Policy), the Laboratory Competency Policy and the Quality Assurance
Field Activity Procedures (QAFAP). In addition, Region 9 has developed a program specific
Quality Management Plan to describe the practices for environmental data collection for cleanup
decisions and work on Navajo Abandoned Uranium Mines (NAUMs). This document is
included as an appendix within the QMP.
The Quality System is employed throughout the life cycle of a project funded by EPA; it
informs the planning, implementation and assessment activities of a project. This QMP
describes the System in place in EPA Region 9. Section 1 provides an overview of the System;
Section 2 lists the related roles and responsibilities of Region 9 management and staff; Sections
3, 4 and 5 discuss the activities in detail; and Section 6 affirms the commitment to maintaining a
dynamic and responsive Quality System. The appendices include organization charts of the
Regional Office and other organization charts that relate to Regional QA activities.
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FOREWORD
The Quality Management Plan (QMP) of the U.S. Environmental Protection Agency (EPA)
Southwest Region 9 (Region 9) represents the commitment of the Region to comply with the
requirements of the Policy and Procedure for Environmental Data Operations (CIO 2105 and
CIO 2105-P-01) to have a quality system in place to support all aspects of environmental data
collection, analysis and reporting. The objective of this system is to support regional
management with data of known quality upon which they may base defensible and appropriate
environmental decisions. The QMP defines the planning and oversight activities related to data
collection activities conducted in the Region and defines the roles and responsibilities for
implementing those activities.
1.0 Quality System Foundation
EPA uses environmental measurements collected by the Agency, other governmental agencies,
grantees, regulated parties, non-governmental organizations and academia to make decisions
affecting public health and the environment. The Quality System (System) requires that each
Program Office and Region establish such a system to ensure that data of known quality are
generated by and for the Agency.
Sections 1. Quality System Foundation and 2. Region 9 Organization present the national
Quality policy and outlines the roles and responsibilities of Region 9 management and the
Quality Assurance Branch to support the Quality system; Section 3. Quality System describes the
Region 9 Quality Assurance Branch's customized approach to working with grantees and
contractors, with Quality Staff and, by extension, the national EPA Quality community in
planning environmental data collection projects. Sections 4. Implementation, 5. Assessment and
6. Quality Improvement detail the activities which encompass the Quality system as practiced by
the Quality Assurance Branch and other Region 9 organizations, such as the Region 9
Laboratory and Enforcement and Compliance Assurance Division and other staff involved in
taking environmental measurements.
1.1 Regional Quality Assurance Goals and Policies
The responsibility to implement the System rests with all Regional staff and managers involved
in data collection activities, including use of data in decision making. The responsibility for
developing and overseeing the implementation of the System resides with the QA Branch
(QAB). The QMP describes the management and technical processes in place to plan,
implement and assess the effectiveness of System operations in Region 9. It defines the roles,
responsibilities and authorities for implementation. The benefits of having such a system in
place include:
Scientific Data Integrity - Data produced, reviewed and used are of known and
documented quality.
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Reliable and Defensible Decisions - Decisions based on data of known quality are more
likely to be upheld if challenged.
Effective Management of Internal and External Activities - All activities during
planning, implementation and reporting stages of data generation are transparent.
Reduced or Justifiable Resource Expenditures - Resources may be used more efficiently
as information collection activities are better aligned with information needs.
Region 9's QA policies and activities are consistent with the requirements of CIO 2105.0 and
other relevant Agency mandates. The basic goals and specific policies are summarized below.
1.1.1 Quality Assurance Basic Goals
Environmental data, including models and data from other sources, used in decision-
making are of known quality.
Data collected are of the type and quality needed and meet established objectives.
1.1.2 Quality Assurance Policies
The following policies apply to all environmental data collection activities conducted by Region
9 personnel and its contractors, grantees and interagency agreement recipients:
Appropriate QA planning documents such as this QMP, Quality Assurance Project Plans
(QAPP), Sampling and Analysis Plans (SAP), Field Sampling Plans (FSP), or Work
Plans (WP) are developed and approved for each environmental data collection activity
prior to the initiation of data collection.
Intended use(s) and data quality objectives (DQOs) of environmental data are identified
prior to collection in the appropriate QA planning document.
Implementation of projects and tasks involving environmental data collection conforms
to information provided in approved QA planning documents.
Oversight of data collection activities is performed and deficiencies promptly corrected.
Programs and projects using existing data or data from modeling or secondary sources
have an approved QA Plan. The plan specifies the quality system will be used to
determine the suitability of the data for the proposed use.
Quality Assurance oversight is performed to ensure that entities such as laboratories
generating environmental data used in Agency and Regional decision making are
competent to provide usable and defensible results.
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Region 9 Policies and/or Orders to strengthen ongoing field activities and to implement a
sustainable management system that incorporates all ten of the Field Operations Group
guidelines were established and implemented on February 1, 2017.
Overall responsibility for Quality Assurance in Region 9 resides with the Regional Administrator
who makes the commitment to ensure adequate resources are allocated to accomplish Program
and Regional goals. Quality Assurance is an integral part of the process of development and
execution of all projects and tasks involving environmental measurement. The Regional
Administrator's responsibility to QA is outlined in Section 2.1.
The responsibility for planning, developing and implementing the Region's Quality System
resides with the Regional Quality Assurance Manager (RQAM). The RQAM reports to the
Director of the Laboratory Services and Applied Science Division (LSASD) (see Appendix B).
The LSASD Director is independent of the other Divisions responsible for collecting
environmental measurements, except for the Region 9 Laboratory, which also resides in LSASD.
The RQAM supervises the Quality Assurance Branch (QAB). The RQAM's responsibilities are
described in Section 2.3.
Other personnel who have specific QA responsibilities include senior staff and technical
personnel located in the Air and Radiation Division's Air Quality Analysis Office (AQAB) (see
Section 2.6.1), the Enforcement and Compliance Assurance Division (see Section 2.6.2), the
Land, Chemicals and Redevelopment Division (see Section 2.6.5), the Superfund Emergency
Response Team (see Section 2.6.7), and the Water Division (see Section 2.6.8). Staff throughout
the Divisions who have quality assurance experience may support the planning document review
process as requested.
2.0 Region 9 Organization
Region 9 is organized into three Offices: Regional Administrator, Public Affairs and Regional
Counsel, and eight Divisions: Air and Radiation; Enforcement and Compliance Assurance;
Laboratory Services and Applied Science; Land, Chemicals and Redevelopment; Mission
Support; Superfund and Emergency Management; Tribal, Intergovernmental and Policy; and,
Water (see Appendix C). The Region also maintains a Laboratory in Richmond, California, and
field offices in Los Angeles and San Diego, California and Honolulu, Hawaii. Each Division has
programs and offices that may generate or oversee environmental data collection activities.
2.1 Regional Administrator
The Regional Administrator:
Retains overall responsibility for the Quality System in Region 9 as described in this
QMP and ensures that all Regional programs comply fully with the requirements of EPA
Quality Manual for Environmental Programs (CIO 2105).
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Ensures that quality management activities are supported by resources adequate to
accomplish program goals.
2.2 Laboratory Services & Applied Science Division Director /Scientific
Integrity Officer
The Laboratory Services and Applied Science Division Director:
Serves as the Scientific Integrity Officer for the Region. In this capacity, s/he is
responsible for resolving disputes related to the Information Quality Guidelines and the
Data Quality Act (PL 106-554 HR 5658 Section 515) and QA implementation issues that
may arise within Region 9.
Supervises the Regional Quality Assurance Manager, the Regional Laboratory and the
Regional Science Liaison.
Acts as a senior management liaison between the Quality Assurance Branch and senior
managers in the other divisions.
Retains overall responsibility for the implementation of the quality management system
within Region 9.
2.3 Senior Management
Has responsibility for ensuring that division and grant recipient data collection activities
conform to Regional quality assurance policies as described in this QMP.
2.4 Regional QA Manager
The RQAM supervises the Quality Assurance Branch in the Laboratory Services and Applied
Science Division (see Appendix B).
The Regional Quality Assurance Manager:
Serves as manager of the Regional QA Program and supervises professional employees
who actively support the Region by reviewing QA documents and technical assistance
when requested.
Prepares the Region 9 QMP, monitors its implementation for all internal monitoring,
measurement, and data collection, review and utilization activities.
Ensures that standards are in place requiring managers and staff to perform specific
quality management functions.
Approves QA planning documents prepared by or on behalf of the Agency for projects or
programs within the region.
Develops policies and procedures for implementation of Quality Assurance/Quality
Control (QA/QC) within the Region.
Reviews and signs the Quality Assurance Review Form (QARF) for contracts.
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Reviews and approves Funding Recommendations and prepares grant conditions as
needed relating to environmental data collection.
Reviews and approves Interagency Agreements when tasks involving environmental
measurements are included in the agreement.
Oversees QA training for internal and external organizations upon request.
Prepares and submits annual reports to Regional management and the Quality Staff
within the Office of Environmental Information, Enterprise Quality Management
Division (Quality Staff). Reviews, revises and submits the QMP every five years for
review.
Works with Quality Staff, and Regional, State, and Tribal counterparts to promote mutual
understanding and coordination in development of QA requirements and implementation
of the System.
Represents the Region on QA matters.
Addresses quality disputes or challenges and consults the Laboratory Services and
Applied Science Division Director and/or RA if needed.
2.4.1 Mandatory Independence of the Regional Quality Assurance Branch
Neither the RQAM nor the QAB is directly connected with any of the media or regulatory
programs within the region. Neither is involved in the collection or analysis of any samples, and
is not responsible for the acquisition and use of secondary data. In the event of a disputed QA
finding, discussion is initiated at the most appropriate level. If staff and supervisors cannot come
to an agreement, the issue may be brought to the attention of the LSASD Director. In some
instances, it may be useful to seek the advice of the Quality Staff or other experts. The RQAM
and staff may bring any issue related to QA directly or where a dispute or challenge cannot be
satisfactorily addressed to the attention of the LSASD Director, s/he may raise the issue to the
RA.
Since the Regional Laboratory is accredited by The National Environmental Laboratory
Accreditation Conference Institute (TNI), that organization might be called upon to facilitate a
resolution process, if necessary. Although both the Regional Laboratory and the QAB report to
the LSASD Director, the two organizations are geographically and functionally separate. The
Regional Laboratory has its own QA system, which the QAB audits every two years.
2.5 Quality Assurance Branch
A table of the QA Branch GS series, responsibilities and years in service can be found in
Appendix A. The Quality Assurance Branch:
Acts as point of contact for information relating to EPA QA concepts and practices.
Ensures all applicable programs delegated to State, Tribal and local governments or
organizations taking environmental measurements pursuant to regulatory programs
comply fully with EPA QA requirements.
Implements provisions in the Regional QMP that apply to oversight of grantees and other
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organizations using EPA funding to collect environmental measurements.
Coordinates the review and approval of alternate test methods according to the
requirements of the Clean Water Act (CWA) Alternate Test Procedure program.
Ensures that QA training and technical support needs are identified and prioritized.
Provides training to assist Federal, State, Tribal, local governments, and non-profit
organizations performing environmental data operations and environmental technology
activities under assistance agreements with EPA.
Performs periodic management assessments of Regional organizational units performing
environmental monitoring programs.
Performs periodic management assessments of EPA funded projects and programs
conducted by State, Tribal, and local governments.
Reviews QA planning documents prepared by or for EPA for projects or programs by
EPA staff, contractors, responsible parties, EPA-funded agencies, or grantees.
Develops and provides guidance in the preparation and implementation of QMPs,
QAPPs, SAPs, FSPs and other QA planning documents.
Facilitates effective planning, implementation, and assessments of data collection
systems through scoping meetings and other forms of technical support.
Oversees Superfund technical service contracts such as the Contract Laboratory Program
(CLP) and the Environmental Services Assistance Team (ESAT). Manages contract
Delivery Orders and Task Orders for technical support of QA-related work.
Manages and implements the Regional project-specific performance evaluation (PE)
sample program; assists EPA programs with the selection of appropriate PE materials and
with the development or procurement of new or customized PE samples; provides
technical assistance in the interpretation of results and with laboratory corrective action
processes.
Performs management and technical system audits of Regional and State environmental
monitoring programs to verify the effectiveness of QA/QC implementation; ensures that
deficiencies or problems identified through audits are corrected.
Provides assessment of data quality related to its usability for Region 9 programs and
their contractors.
Reviews and approves state Discharge Monitoring Report-Quality Assurance (DMR-QA)
Study waiver requests in coordination with the Enforcement and Compliance Assurance
Division.
2.6 Regional Organizations with QA responsibilities
2.6.1 Air and Radiation Division
The Air and Radiation Division is responsible for implementing the programmatic provisions of
the Clean Air Act (CAA) within the geographic boundaries of Region 9, including the Mexican
border. The Division conducts activities to reduce emissions so air pollution does not constitute
a threat to public health, safety, well-being and the environment. To carry out its mission, the
Division works with other federal agencies, state and local agencies, tribal governments, the
public, and the private sector. The Air Program guides the federal management, implementation,
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and technical oversight of ambient and indoor air quality, including control of pollution from
stationary and mobile sources, prevention of radiation exposure and protection of the
stratospheric ozone layer.
In assuring compliance with the requirements of the CAA, the Division performs a wide variety
of functions, including developing, reviewing, and implementing air quality plans (State
Implementation Plans) and related regulations/rules; issuing permits; administering grants to
state and local agencies, tribes, and non-governmental organizations (NGOs); and ensuring
compliance with the CAA.
The Division works with the QAB to perform the ambient air monitoring quality assurance
functions required by the CAA such as Technical System Audits. The QAB also provides
technical support for air methods development and oversees a voluntary quality improvement
program through round-robin performance evaluation studies. Grants managed by the Division
are reviewed by the QAB to ensure quality assurance planning document requirements are
addressed. The QA Office reviews internal QAPPs and State and Tribal QMPs and QAPPs.
2.6.2 Enforcement and Compliance Assurance Division
The Enforcement and Compliance Assurance Division is responsible for developing and
implementing Regions 9's enforcement and compliance assurance programs and statutes EPA
administers in California, Arizona, Nevada, Hawai'i, the Pacific Island Territories and 148 federally-
recognized tribal nations. The Enforcement and Compliance Assurance Division works closely with
the other Region 9 divisions, Office of Regional Counsel (ORC), Criminal Investigations Division
(CID), and Department of Justice (DOJ) to deliver a comprehensive enforcement and compliance
assurance program utilizing the entire spectrum of compliance assurance tools available to the
region. This includes strategic planning for enforcement, compliance monitoring and compliance
assistance activities, conducting inspections, developing enforcement cases, preparing and issuing
administrative actions, assessing penalties, developing judicial enforcement actions, negotiating
settlements, measuring and reporting results of the Region's enforcement efforts.
The QAB reviews QAPPs, inspection SAPs and provides technical assistance to staff as
requested.
2.6.3. Laboratory Services and Applied Science Division
The Laboratory Services and Applied Science Division provides laboratory analytical support for
the region's media programs and enforcement programs, as well as dedicated field services. The
Division coordinates with regional media and enforcement programs to ensure the effective
collection and analysis of environmental data and makes certain the data collected, reported and
used in the Region is properly documented and sufficiently accurate to meet the data quality
objectives of program needs. The Division manages implementation of the Region's mandatory
Quality Assurance System, operates the Region 9 Laboratory and provides scientific and
technical support to the Region.
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2.6.4. Land, Chemicals and Redevelopment Division
The Land, Chemicals and Redevelopment Division is responsible for providing leadership and
direction on regional multimedia issues, emphasizing and promoting cross-program and place-
based approaches to address regional environmental issues. The Division oversees, manages,
and directs the activities related to the Resource Conservation and Recovery Act (RCRA), the
brownfields provisions of the Comprehensive Environmental Response, Compensation and
Liability Act, Federal Insecticide Fungicide, Rodenticide Act (FIFRA), Residential Lead Based
Paint Hazard Reduction Act, Toxic Substances Control Act (TSCA), Asbestos Hazard
Emergency Response Action (AHERA), the Asbestos School Hazard Abatement Act (ASHAA),
and the Pollution Prevention Act.
Grants managed by the Division are reviewed by the QAB to ensure quality assurance planning
document requirements are addressed. The QAB reviews data collection SAPs for several Land,
Chemicals and Redevelopment Division programs.
2.6.5 Mission Support Division
The Mission Support Division is responsible for providing leadership, support, communications
and direction to ensure efficient operations vital to EPA and regional goals. The Mission
Support Division Director holds the roles of Senior Resource Official (SRO) and Senior
Information Official (SIO), and advises the Regional Administrator and Deputy Regional
Administrator, senior leadership, and management on regional and national policies involving
strategic planning, performance tracking, technical, and resource management issues. The
Division provides management and technical program development of the region's physical
space, contract and grant administration, financial, human resources, health and safety, and
information resources.
The QAB coordinates with the Mission Support Division to ensure the Region's QA System is
integrated in the Region's grants and contracts and communicated to the Region's Project
Officers. The QAB also provides technical assistance to staff as requested.
2.6.6 Office of Public Affairs
The Office of Public Affairs is located in the Office of the Regional Administrator and
communicates Region 9 program activities and policies to its stakeholders, including the public,
the media, state and local governments, state legislatures and Governors' offices, Congress, the
international community, the academic community, and special interest and non-governmental
organizations. It serves as the gatekeeper for all Region 9 information products, ensuring
quality, coordination and consistency with Agency priorities and standards. The Office works
with the Mission Support Division and the QAB to ensure that communications are consistent
with the Region's and the Agency's policies relating to the Data Quality Act and the Information
Quality Guidelines.
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2.6.7 Office of Regional Counsel
The Office of Regional Counsel is responsible for preparing administrative, judicial and criminal
cases against violators of environmental laws. The primary statutes enforced by the EPA are the
Clean Air Act, Clean Water Act, Safe Drinking Water Act, Toxic Substances Control Act,
Resource Conservation and Recovery Act, Comprehensive Environmental Response,
Compensation and Liability Act (Superfund) and the Federal Insecticide, Fungicide and
Rodenticide Act. The Office of Regional Counsel works collaboratively with State, Tribal, and
local governments to implement national environmental laws.
In addition to preparing enforcement actions, attorneys are also responsible for counseling the
Regional Administrator and Program Division Directors on the interpretation of environmental
laws, regulations and policies. Attorneys are expected to participate in civil or criminal litigation
of cases referred to the Department of Justice and to represent the Agency in administrative
proceedings.
The QAB provides attorneys with technical and QA-related information upon request.
2.6.8 Superfund and Emergency Management Division
The Superfund and Emergency Management Division recommends goals, priorities, and
objectives for implementation of activities pursuant to the Comprehensive Environmental
Response Compensation and Liability Act of 1980 (CERCLA); Section 311 of the Clean Water
Act (CWA), as amended by the Oil Pollution Act of 1990 (OPA); the Emergency Planning and
Community Right to Know Act; the National Oil and Hazardous Substance Pollution
Contingency Plan (the National Contingency Plan or NCP) and the National Response Plan;
aligning with the HQ's Office of Land and Emergency Management and the Office of
Enforcement and Compliance Assurance (OECA). This Division has overall responsibility for
ensuring that Region 9 executes its responsibility for managing resources and personnel for
emergency responses, removal and remedial response actions, hazardous substance and oil spill
prevention activities, cost recovery, and contingency planning and preparedness activities
involving oil and hazardous substances.
The Division coordinates with the QAB and the Regional Laboratory as needed for technical
assistance, field services and document review. The Emergency Response Team has an
approved QMP to support quality assurance requirements for data collection in emergency
situations. In 2019, the Navajo Abandoned Uranium Mine Program collaborated with the QAB
to develop a QMP that communicates the practices for environmental data collection. It
describes the quality system for data-driven decisions and delegates responsibility for reviewing
and approving QA documentation and records retention for the complex program (Appendix D).
Grants and contracts administered by the Superfund and Emergency Management Division are
reviewed by the QAB to ensure quality assurance planning document requirements are
addressed. The QAB reviews internal QAPPs, QARFs and State and Tribal QMPs, QAPPs and
SAPs and provides technical support for emerging issues, such as sampling design for vapor
intrusion studies.
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2.6.9 Tribal, Intergovernmental and Policy Division
The Tribal, Intergovernmental and Policy Division was developed under the realignment and
provides support to Region 9's communities including, Tribes, the Pacific Trust Territories and
Freely Associated States, and the U.S.-Mexico Border. The Division also works closely with
various federal agencies to provide technical assistance in complying with the National
Environmental Protection Act and manages the Environmental Justice Program.
Grants administered by the Division are reviewed by the QAB to ensure quality assurance
planning document requirements are addressed. The QA Branch also provides technical
assistance as needed to staff.
2.6.10 Water Division
The Water Division ensures drinking water is safe, and restores and maintains watersheds and
their aquatic ecosystems to protect human health, support economic and recreational activities,
and provide healthy habitat for fish, plants, and wildlife. The Division implements the
provisions of the Clean Water Act (CWA), as amended, the Safe Drinking Water Act (SDWA),
as amended, and the Marine Protection, Research and Sanctuaries Act (MPRSA) within the
geographic boundaries of Region 9. The Water Division provides technical assistance to protect
public health and achieve environmental results; oversees the implementation of the Clean Water
Revolving Fund and Drinking Water State Revolving Fund programs; conducts oversight of
delegated/authorized state and tribal programs, directly implements federal programs where not
delegated/authorized; and conducts audits and assessments under the CWA and SDWA.
The QAB staff who evaluate Alternate Test Procedure applications communicate with the
Division's National Pollution Discharge Elimination System (NPDES) Permits Office. Grants
administered by the Division are reviewed by the QAB to ensure quality assurance planning
document requirements are addressed. The QA Branch also provides technical assistance as
needed to staff.
3.0 Regional Quality System
3.1 Overview
It is Agency and Regional policy that systematic planning be used for all projects involving the
collection of environmental measurements. Managers make decisions based on information
provided by staff, technical advice and regulatory requirements. The QAB supports all planning
efforts by helping staff understand the level of data quality needed to make informed decisions
and to weigh the short-term and long-term costs associated with that level of quality.
3.1.1 The Graded Approach
As different programs have specific requirements for data upon which decisions are to be made,
Region 9 uses a graded approach to fit the level of planning to program requirements and
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commensurate to program resources. This approach applies to all stages of data generation
activity and to the use of environmental data subsequent to its collection. Implementation of the
graded approach is discussed in the following sections.
3.2 System Level Planning
If an organization is of such size and complexity that it encompasses several programs with
different data collection requirements, management support for quality is documented in a QMP
(www.epa.gov/quality/epa-qar-2-epa-requirements-quality-management-plans). The Region 9
QMP is available online at www.epa.gov/qualitv/quality-management-plan-epas-pacific-
southwest-region-9. This policy document describes the organization's quality system,
management and staff roles and responsibilities, and the general systematic planning process
that are expected for all programs.
3.3 Program Level Planning
The objective of environmental data collection is to provide information that may be used to
implement environmental programs such as State and Tribal environmental programs funded
under the federal environmental laws, including the Comprehensive Environmental Response,
Compensation, and Liability Act (CERCLA); the Clean Air Act (CAA); the Clean Water Act
(CWA); the Brownfields Program; the Safe Drinking Water Act (SDWA); the Resource
Conservation and Recovery Act (RCRA); and the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA). For some programs, human health-based criteria defined in the
legislation or their State or Tribal equivalents guide decision making; in others,
presence/absence, registration or permit defined requirements drive the data collection process.
The criteria associated with each program should be cited in QAPPs to allow appropriate
technical and policy review of the steps being taken to ensure that data generated are of known
quality.
The QAPP (www.epa.gov/quality/qualitv-assurance-planning-epas-pacific-southwest-region-9)
provides a detailed record of the scope and objectives of the data collection and Quality
Assurance/Quality Control (QA/QC) procedures to be used throughout a program, and defines
a quality assurance system that will include development of supporting documents, such as
QAPPs and SAPs.
3.3.1 Graded Approach at the Organization or Program Level
The QAB works with grantees and other organizations to determine the type of planning
document most appropriate for their programs. The QAB may require a QMP with supporting
QAPPs, a combination QMP/QAPP or a singular QAPP be prepared. The QAB works with the
State, Tribal or grantee organization to determine the most appropriate planning document. For
example, for many Tribal organizations receiving grants from the Region, preparation of
QAPPs is sufficient to meet project goals and define their environmental data collection
activities. This determination is evaluated on a case-by-case basis. If a grantee organization
has a staff of fewer than five individuals, the preparation of a QMP is generally not resource
effective. A State program commonly prepares a QAPP, but may prepare a QMP or a hybrid
QMP/QAPP, depending on the scope and the structure of its quality system.
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As the QA function in the Region is centralized and the QAB assists all Divisions in
implementing the QMP, the Divisions are not required to prepare separate QAPPs. Most
measurement activity conducted directly by the Region is covered under project specific
documents prepared by EPA staff or by contractors who work directly for EPA. For example,
the Pesticide Enforcement Program has an approved QAPP that covers the activities of EPA
inspectors or inspectors for State and Tribal agencies working under Federal authority. The
Emergency Response Team has developed a QMP based on the specific need to ensure that the
work conducted under emergency conditions is also of known and legally defensible quality.
3.4 Project Level Planning
3.4.1 Scoping Meetings
Many organizations that conduct environmental measurement collection activities have a good
understanding of the type of QA planning document their work requires. They usually proceed
without consulting with the QAB. However, whenever appropriate, the QAB encourages an
organization to participate in a scoping meeting before a plan is written. Scoping meetings,
which can be held in person or by teleconference, are attended by the EPA Project Officer (PO)
or Remedial Project Manager (RPM) or his or her designee, the EPA Task Manager if an EPA
contract is involved, a representative of the organization preparing the plan, and QAB staff.
The QAB considers scoping meetings to be integral to the effectiveness of the Region 9 Quality
System. During these meetings, the participants systematically review all aspects of a project,
including the objectives, decisions, sample design, collection activities, data analysis, quality
control, and data assessment. Decisions are made as to the type of QA planning document that
should be prepared, the appropriate analytical methods to be used, and the level of quality
control necessary to achieve project objectives. Finally, the common understanding reached at a
scoping meeting will facilitate review when the planning document is submitted to the QAB for
review and approval.
3.4.2 Setting Project Data Quality Objectives
Data Quality Objectives (DQOs) are quantitative and qualitative statements that specify the
acceptable error rates associated with environmental measurements for decision making
purposes. The DQO process is designed to ensure that the type, quantity, and quality of the
environmental data collected are appropriate to support specific decisions or regulatory actions.
Working through the DQO process helps the project proponent define the criteria that data
collection design must satisfy, including what type of data are needed, why they are needed, how
they will be used and who will use them; the tolerable error rate and level of QA/QC to be
implemented; an evaluation of alternative data collection and analytical approaches; the level of
data review, self-audits to be performed, corrective actions to be implemented, and any
constraining factors. This process of selecting DQOs, which is detailed in Data Quality
Objectives Process (www.epa.gov/sites/default/files/2015-06/documents/g4-final.pdf), is the
primary systematic planning tool for developing projects performing environmental
measurements, but the Region is flexible and open to the use of other planning tools or
approaches that meet project requirements.
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For some routine monitoring programs and regulatory programs, the EPA National Program
Offices have developed DQOs, usually in the form of regulatory standards. Those DQOs are
adopted by the delegated agencies that are primarily charged with implementing these programs.
They are incorporated into planning documents for specific activities. For projects initiated in
the Region, the PO is responsible for defining, citing, or developing DQOs as part of the
planning process.
3.4.3 Graded Approach at the Project Level
Region 9 supports a wide variety of environmental data collection projects. It is Region 9 policy
to ensure that the type of QA planning document required and the level of QA/QC to be
implemented are commensurate with the objectives of the project. For some projects, a narrative
description of the quality system may be sufficient. Other projects may require a QAPP with
appendices containing sampling and analytical Standard Operating Procedures (SOPs).
Although use of Agency or Regional guidance for preparing documents is generally
recommended, some project activities do not lend themselves to these formats and EPA staff,
grantees, or contractors may need to work directly with the QAB to develop an appropriate
document.
3.5 QA Annual Planning
Annual planning for the QAB ensures resources are used efficiently to accomplish the Region's
QA activities. Planning is undertaken at two levels: QAB goals are included in the Region 9
Laboratory Services and Applied Science Division Operating Plan and annual planning goals are
included in the Quality Assurance Annual Review and Workplan (QAARWP) submitted to the
Agency Quality Staff.
3.5.1 Regional QA Planning Process
The primary vehicles for annual planning in the region are the budget process, the Annual
Commitment System (ACS), State/EPA annual grant workplan process and the Regional
Operating Plans. The Deputy Regional Administrator allocates resources to each division for the
management and operation of specific programs, based on the Region's anticipated budget.
Support from the QAB helps the Region meet Agency Government Performance Results Act
(GPRA) goals, program goals, and ACS commitments.
Most Regional work activities are mandated by policy and tracked via the commitments made in
Program Office Strategic Plans. The Strategic Operating Plan contains commitments in the form
of the coming fiscal year's activities. The QAB seeks input from the divisions with which it
works in preparing its Strategic Operating Plan.
3.5.2 National QA Planning Process
The Region's Quality Assurance Annual Report and Work Plan (QAARWP) is prepared as part
of the annual Regional planning process and contains descriptions of Regional, State and Tribal
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activities. It also includes information about the range of activities completed, the significant
fiscal year QA accomplishments and provides updates to the Regional QMP. The QAARWP is
submitted by the Region to the Director of the Enterprise Quality Management Division in the
Office of Environmental Information, who uses the information for short- and long-term
planning purposes.
3.5.3 QA Office Planning Process
The QAB uses several resources to assess the adequacy of the quality system during the year,
including referring to the QA document review database for the status of all types of QA
documents; occasional meetings with the Superfund QA liaison and Regional Laboratory;
regular meetings with the Air Quality Analysis Office; and follow-up meetings with State and
Tribal grant POs in the Air, Land and Water Divisions as grants are awarded during the year. As
necessary, the RQAM meets with State program managers and their Quality Assurance branches
to discuss quality system issues. Audits and trainings are scheduled based on information from
these sources.
3.6 Planning Documentation
3.6.1 Policies
All environmental measurement projects conducted by Agency personnel, its contractors,
grantees and interagency agreement recipients are required to have an appropriate QA
planning document approved by the QAB prior to the initiation of data collection. The
document is developed in accordance with regional and national guidance, and is
available on the Quality QA Web page.
Projects that use existing data or data from secondary sources are also required to have an
approved QA Plan. The plan should specify the quality system that will be used to
determine the suitability of the data for the proposed use. States or Tribes conducting
regulatory programs that provide data to Region 9 are required to have their own QA
systems in place. These QA systems are subject to QAB review and approval.
After approval, the final documents are retained by the project manager. Approved QA
planning documents remain in effect for five years; they are updated annually as
necessary. After five years, they are reviewed and revised to reflect the current activities
being performed and submitted to the QAB for approval.
A State program that has an approved QMP and/or QMP/QAPP(s) in place which has
been evaluated by the QAB to ensure that it meets EPA requirements may review and
approve internal- and contractor-generated QAPPs, SAPs and FSPs.
3.6.2 Types of QA Planning Documents
The success of an environmental program or project depends on the quality of the environmental
data collected and used in decision-making. Decisions depend significantly on the adequacy of
the quality assurance planning documents developed for the organization, project or sampling
effort.
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3.6.2.1 Quality Management Plans
A QMP outlines the structure of an organization's quality system and its underlying QA
management policies. EPA generally requires that a QMP be in place for organizations with
which it has contracts, grants and cooperative agreements, but the Region takes a flexible
approach in implementing this policy. Region 9 requires that QMPs follow the guidance EPA
Requirements for Quality Management Plans (QA/R-2) (EPA/240/B-01/002, March 2001). An
organization may also work with the QAB to develop an alternative approach. Such an approach
must still contain the major elements found in QA/R-2, but may emphasize or delete certain
sections. In some cases, Region 9 accepts documentation of an organization's quality system in
a combination QMP/QAPP.
3.6.2.2 Quality Assurance Project Plans
The planning of project-specific data collection activities is documented in QAPPs or equivalent
documents, such as SAPs (discussed in Section 3.6.2.3). QAPPs may be prepared by Region 9
staff or contractors, grantees, responsible parties, or contractors employed by these
organizations. When implemented as written, the QAPP provides a detailed record of the scope
and objectives of data collection activities, procedures, and QA/QC requirements. QAPPs are
prepared using EPA Requirements for Quality Assurance Project Plans for Environmental Data
Operations (QA/R-5, March 2001).
It is encouraged that QAPPs be reviewed by the submitting organization every year. However,
every five years QAPPs must be reviewed and revised, if appropriate, by the submitting
organization and sent to the QAB and the Region 9 PO/RPM for approval.
3.6.2.3 Sampling and Analysis Plans
Sampling and Analysis Plans (SAPs) combine elements of a QAPP and an FSP (see Section
3.6.2.5), and are prepared for one-time sampling events that are intended to be limited in scope.
Although any format is acceptable provided it covers the necessary material, two guidance
documents, Sampling and Analysis Plan (SAP) Guidance and Template, Version 4 (R9QA/009.1,
May 2014) and Sampling and Analysis Guidance and Template, Version 3, Brownfields
Assessment Projects (R9QA/008.1, August 2012) are available on the Agency Quality website
for use.
3.6.2.4 Field Sampling Plans
Field Sampling Plans (FSPs) are planning documents for activities taking place within a longer-
term project that has a QAPP in place; the larger project usually includes multiple sampling
events that have specific data quality objectives. There is no specific guidance for FSPs; an
abbreviated version of Sampling and Analysis Plan (SAP) Guidance and Template, Version 4
(R9QA/009.1, May 2014) may be used. The QAB review focuses on reviewing the sampling
design, as it is assumed that information about project data quality objectives, intended uses of
the data, sampling methods, analytical methods, and data review is available in the overarching
QAPP. Approval of an FSP is limited to the specific sampling event.
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3.6.2.5 Other Quality Assurance Planning Documents
If the standard elements of a QA planning document are not relevant to a specific project, a
narrative statement or expanded workplan may be sufficient. Specialized QA planning
documents may be appropriate for projects involving the use of databases, secondary data or
models. Alternatives such as the Region 9 guidance for recipients of wetlands grants or the
Office of Research and Development QAPP for research projects may also be appropriate.
Questions as to which guidance to use or approach to take should be directed to the QAB and are
often discussed in the scoping meetings described in Section 3.4.1.
3.6.3 Review and Approval of QA Planning Documents
Region 9's QA planning documents are approved by the Region 9 QA Manager, unless another
process has been described for review and approval in a Region-specific QMP (examples include
the Region's Emergency Response QMP and the NAUM QMP). Documents produced by
grantees to describe media project goals are reviewed by the QAB and approved by the Region 9
QA Manager. The PO overseeing the grant reviews the planning document for conformance to
program requirements.
3.6.4 Quality Assurance Guidance Documents
Guidance for preparing planning documents for all types of projects may be found on the EPA
Quality website (www.epa.gov/quality). Region 9 has prepared several guidance documents
which exist on the Quality website to assist organizations in writing QA planning documents,
including the QAPP guidance, SAP guidance documents and the QAPP guidance for wetlands
projects. In addition, a CD ROM containing guidance material, a template, SOPs and references
for surface water monitoring is available.
4.0 Implementation
4.1 Overview
The Quality System is implemented throughout the Regional Office. Review of planning for
environmental data collection activity and subsequent implementation oversight are the
responsibility of the QAB; other relevant and ancillary activities are supported by other Region 9
Divisions and Offices.
4.2 Document Review
4.2.1 Quality Assurance Branch Review Process
A primary responsibility of the QAB is document review. Documents may be submitted to the
QAB by Remedial Project Managers, POs or external organizations. Staff that have appropriate
expertise in the subject area and document type are assigned to perform the review. A peer
review process within the QAB is completed before a memo (for internal reviews) or a letter (to
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the grantee) relaying information about the status of a quality assurance document is submitted to
the QA Manager for signature. Occasionally, a Remedial Project Manager with QA expertise
will review a document. The QAB can evaluate such reviews to ensure consistency with Agency
and Regional QAB policy. The service standard for document review is 120 days for QMPs, and
60 days for QAPPs, SAPs and FSPs, although this timeframe is subject to negotiation.
During the course of its review, the QAB assesses whether the document is consistent with
national and Regional QA guidance and whether the proposed QA/QC activities support the
program or project data quality objectives. The QA reviewer may interact directly with planning
document authors throughout the planning process (see Section 3.4.1). Formal comments that
identify areas of project QA vulnerability are prepared. The author responds to the review to
address the comments and resubmits the plan. This iterative process continues until the planning
document is approved.
Comments from POs or Remedial Project Managers may be incorporated into the document and
sent via review memorandum or letter. Reviews may be transmitted independently of the QAB
through the PO/RPM or, may be sent by the QAB directly to the grantee, as requested by the
programs.
4.2.2 Other Document Review
One office in the Region has been delegated responsibility for review of QA documents: the
Emergency Response Team in the Superfund Division. The Emergency Response Team has an
approved QMP that describes how the Quality System will be implemented by the organization,
which often operates within very tight deadlines.
The NAUM QMP also describes a collaborative process by which the Remedial Project Manager
or the On-Scene Coordinator works closely with QAB to review and approve QAPPs.
A State or Tribe having a quality system in place that has been described in an EPA-approved
QMP may receive authorization from EPA to review and approve its own QA documents. The
QAB must be satisfied that the State or Tribe's implementation of its quality system is
sufficiently rigorous to ensure that reviews meet EPA Region 9 standards. Currently, no State or
Tribal organization has authorization to review and approve QAPPs that describe environmental
data collection funded by EPA.
4.3 Training
The QAB provides a variety of trainings designed to meet the needs of specific target audiences.
The training may be generated by the QAB based on an internal assessment or in response to a
program or external request. Trainings may be designed to be informational or practical.
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4.3.1 Quality Assurance Branch Staff Competency
Region 9 ensures the QAB staff have a combined technical knowledge including a variety of
environmental science backgrounds and certifications. The staff are trained to interpret
information and apply appropriate guidance while performing their daily work.
4.3.1.1 Document Review
New reviewers and reviewers working in areas outside their original expertise are trained by
performing parallel reviews with senior staff until it can be demonstrated that they understand
how to interpret and apply the appropriate guidance. They are encouraged to take additional
training online and in-classroom format as time and resources permit.
4.3.1.2 Technical Training
QAB staff are classified as chemists and environmental scientists with backgrounds that include
specialized training in inorganic chemistry, organic chemistry, hydrogeology, engineering,
biochemistry and biology. Staff are encouraged to keep current in their specialties and to expand
their areas of expertise to meet emerging needs. Staff may take training in bioassessment, air
quality monitoring, chemistry, hydrology, and genomics offered by EPA or state agencies. Staff
who oversee contractors as Contract Officer Representatives (COR) take contract management
and technical training required to maintain the mandatory COR and federal FAC-COTR
certification.
4.3.1.3 Documentation of Training
Documentation of all formal training is maintained in the individual's personnel file. Contract
management training and certification is documented in the FAITAS database. Other required
training is documented in the e-learning database.
4.3.2 In-House and External Training
The QAB uses surveys and interviews to identify training needs for programs and grantees. In
this way, the training may be customized to meet specific needs. In general, the QAB responds
to all training requests for standard presentations and specific topics. The QAB also sponsors
training from outside sources. Examples of QAB trainings include:
Introduction to QA for new Superfund Remedial Project Managers
Introduction to QA for Division managers
Uniform Federal Policy and QA Planning, a sponsored training for federal and state
agencies
How to work with the QA Office for Water Tribal Program POs
Preparing a QAPP for Tribal Pesticide Enforcement Officers
Clean Water Act 106 and 319 QA requirements for Tribes
QA and related Statistics for Hawai'i Department of Health Clean Water Branch
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QA policy for collecting Volatile Organic Compounds in soil for internal field staff
Bioassessment training for staff and Tribes
Implementing the Laboratory Competency Policy for Grants
Clean Air Act Program Introduction to Quality Assurance/Quality Control Requirements
Vapor Intrusion Study Design
4.4 Procurement of Items and Services
4.4.1 Procurement Activities
The procurement activities in the QAB that consist of purchases under $3000
(microprocurement) are made through the Mission Support Division. Simplified Procurements
are those procurements for supplies and services under $100,000 and basically are of an off-the-
shelf type. The Regional Contracts Office places and administers selected contracts over
$100,000; places and administers orders against Government Wide Agency Contracts and
Schedule Contracts of other agencies; and administers those contracts put in place for the Region
by the Office of Acquisition Management at Headquarters (HQ). Contract activities for other
Program Offices are developed by the user in the appropriate Division.
4.4.2 Contracts Involving Environmental Measurements
Regional procurements involve several steps. A Program Office first identifies its requirements
and develops the technical specifications, evaluation criteria, and any certifications that may be
required. These are documented on an Electronic Purchase Request Form that is electronically
reviewed and approved by the Section Manager and Division Director, funded by the funding
control staff, and submitted to the Contracting Officer (CO) for action. Changes to procurement
requirements undergo the same electronic review and approval sequence.
Whether it is to be made at the Headquarters or Regional Contracting Office, procurement of the
requested items or services is undertaken by the CO according to Federal Agency regulations
detailed in the Federal Acquisition Regulations (FAR), EPA Acquisition Regulations (EPAAR),
EPA Contracts Management Manual, and the Procurement Policy Notice (PPN) Regulation
No. 01 -02, Guidance for Use of Higher-Level Contract Quality Requirements in Acquisitions
March 2001, which provides guidelines for addressing EPA quality requirements for
environmental data collection and use. The procurement process is documented in the contracts
file pertaining to the particular action.
When environmental measurements are performed by contractors, QA requirements are
integrated into the statements of work. In accordance with PPN No. 01-02, the contract-level
COR generates a Quality Assessment Review Form (QARF), which defines the appropriate
types of QA planning and oversight activities and is signed by the RQAM. In many cases, a
QMP or QAPP is due with the proposal or soon after contract award. The QAB may review the
QA provisions of the Request for Proposal (RFP) or contract. If a contract includes
environmental data collection activities, the QAB participates on the technical evaluation panel.
The QAB also participates in the initial briefing session with the contractor to provide
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information about the Region 9 QA process. As a contract task is assigned, the appropriate QA
planning document is generated and forwarded by the Work Assignment Manager (WAM) or PO
for QAB review. Once the QAB completes its review and approval of the planning document,
the WAM or PO has the responsibility for performing oversight to ensure the activities covered
are implemented as described.
4.4.3 Grants and Financial Assistance Agreements
If States, Tribes and non-profit organizations (NGOs) that assist the Agency in carrying out its
mission use EPA funding to perform environmental measurements, they are required under 40
CFR 31.45 to demonstrate that the organization has a quality system in place. These grants are
processed through the Integrated Grants Management System (IGMS). The process generates
Funding Recommendations (FR) that POs must complete in order to award the grant.
In Region 9, all Funding Recommendations are routed through the QAB for review and
approval. The QAB reviews the description of the activity being funded and the PO's responses
to specific QA questions against information in the QAB document review database. A decision
is made whether to add a QA requirement to the grant Terms and Conditions. These conditions
inform the grantee as to what type of QA planning document must be prepared for the project
and provides a deadline for its submittal.
Once the recipient signs the grant and returns it to EPA, the grant condition is considered final.
Region 9 policy does not require that QA plans or related documents be submitted with
proposals or work plans; all documents are created after the grant is funded and after a scoping
session has been held. This allows grant funds to be used to prepare the appropriate QA
planning document.
The grantee and EPA PO work together to determine when the QA planning documents are to be
submitted as a project deliverable. The PO reviews the QA planning documents for
conformance with programmatic goals and work plan objectives. The document is then
forwarded to the QAB for review. Once the QA Office completes its review and approves the
planning document, oversight responsibilities revert to the PO or Task Monitor, unless a special
request is made for further QAB involvement.
4.4.3.1 Laboratory Competency
In 2011, the Agency issued the Policy to Assure Competency of Laboratories, Field Sampling
and Other Organizations Generating Environmental Measurement Data under Agency-Funded
Acquisitions. The intent of the policy is to ensure that all recipients of government funding
collecting and using environmental measurements evaluate and attest the competency of the
laboratories they use or plan to use.
Recipients of EPA grants that include taking environmental measurements are required to 1)
submit a Quality Assurance Project Plan (QAPP) for EPA Regional QA Office approval prior to
award; and 2) submit documentation of laboratory competency for EPA awards greater than
$200,000. Documentation concerning the laboratory may be submitted with the QAPP.
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Documentation of laboratory competency must be submitted to EPA prior to award of the
agreement or, if not practicable, prior to beginning any work involving the generation or use of
environmental data under the agreement. This policy became effective for implementation on
October 1, 2013.
4.4.4 Interagency Agreements
Region 9 works with a number of other Federal agencies, including, but not limited to, the Army
Corps of Engineers, the Indian Health Service, the U.S. Fish and Wildlife Service, the Bureau of
Reclamation, the Bureau of Land Management, the U.S. Forest Service, the National Oceanic
and Atmospheric Administration (NOAA), the U.S. Coast Guard, the Centers for Disease
Control and the U.S. Geological Survey. Generally, these agencies have their own quality
systems in place. However, Region 9 may require that the organization prepare a project-
specific QAPP, depending on the nature of the project.
4.5 Quality Documentation and Records
4.5.1 Regional Records Management System
A records management program provides for storage and timely retrieval, secure storage and
preservation of government records, minimizes potential loss of or damage to those records, and
ensures cost effective use of available storage space. All employees are responsible for ensuring
that Agency records are maintained in a proper manner.
Regional records management policies and guidance are contained in the Agency's Records
Management Policy CIO 2155.4, August 22, 2018. The Policy contains information on topics
such as records and files management, transferring records to the Federal Records Center,
requesting records from the Federal Records Center, and records retention and destruction. The
disposition of records is governed by the General Records Retention Schedules and EPA
Retention Schedules that specify how long EPA records must be kept and when they may be
destroyed.
Records management assistance and training are provided by the Regional Records Management
Officer (RMO) in the Computer Systems, LAN and Telecom Program of the Mission Support
Division. The RMO also serves as the primary liaison with the local Federal Records Center,
coordinates the transfer and retrieval of records, and assists offices in completing necessary
forms and handling special situations.
4.5.2 Quality Assurance Documentation and Records
4.5.2.1 Hard Copy Records
Copies of final approved versions of planning documents should be maintained by the PO as a
grant deliverable. Superfund documents are then moved to the Superfund Records Center for
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long term storage. The QAB keeps a comprehensive file of all signed QA reviews and approved
plans for reference, if needed. Signed reviews are also saved in .pdf format as the QAB moves
to all electronic record keeping. The original memorandums are sent to the Tribe or State
program and/or PO, in electronic and/or hard copy, depending on the customer's request.
4.5.2.2 QA Document Tracking Database
A Document Review spreadsheet is used to monitor and track the status of reviews or approvals
of QA planning documents, reviews of reports or other documents not requiring approval and
audits. Each entry in the spreadsheet receives a unique document control number (DCN). The
DCN tracks each document from initial submittal through one or more iterations to final
approval. Once a document is approved, the spreadsheet record is closed and the DCN is retired.
If an approved document is later amended or revised, a different DCN is assigned to the new
document. The spreadsheet may be sorted in any of its fields. It can be searched by several
categories, which allows workload and timeliness statistics to be calculated. For ongoing grants
and cooperative agreements, the spreadsheet is consulted to determine the status of QA
documentation so that appropriate conditions may be added to grant Funding Recommendations
(see Section 4.4.3). The RQAM keeps a separate spreadsheet that lists all actions taken that
require a QAB signature, including date, DCN, associated grantee, Regional and QAB staff.
4.5.2.3 Document Retention
It is Region 9 QAB policy to send approved QA documents to the Project Officer or grantee who
generated them for their records or archives. The QAB requests that documents be sent
electronically to reduce paper and physical storage space use. QAB will also retain QA
documents from some programs in order to provide them to those programs to use as models for
other grantees.
4.5.3 Quality Assurance Guidance Documents
Regional QA guidance documents have been developed for use in the absence of Agency-wide
guidance on particular types of projects, or when specific Regional processes need to be
documented. Examples include:
Regional guidance documents for preparing non-Contract Laboratory Program (CLP)
laboratory data packages
EPA Region 9 Guidance in the Preparation of QAPPs
Wetlands QAPP Guidance
QAPP Preparation Tool for Tribes (with Region 1)
SAP Guidance and Template
SAP Guidance and Template for Brownfields Projects
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These plans are available on the EPA Quality Assurance webpage at www.epa. gov/quality.
Regional QA guidance documents are drafted by QAB staff experienced in the subject area and
reviewed by the RQAM and other subject-area peers before approval by the RQAM for
distribution. Unique document control numbers are assigned to each document. Revisions are
prepared and transmitted as needed.
4.6 Computer Hardware and Software
4.6.1 Regional Information Resources Management Policies
The Infrastructure Services Branch (ISB) in the Mission Support Division has the primary
responsibility for setting policy and guidance for the management and development of computer-
related programs. It supports the Local Area Network (LAN), Geographic Information Systems
(GIS), information security, and application development. It includes the Desktop Services
Office, which is responsible for division LAN support, training and records management.
Personal Computing/Laptop coordinators in each Division act as liaisons between ISB and
division staff. Program administrators coordinate activities relating to their databases. As these
are national databases, maintenance requirements are defined by the national program offices.
Regional data are collected, processed, and managed by the program divisions. ISB manages the
hardware, software and networking platforms. It also coordinates with the program divisions on
hardware and software issues, purchases and upgrades, and pilot programs.
NIST Security Publication 800-53 requires all federal agencies to have an information security
program. The issue of security impacts all aspects of the Agency's information technology
infrastructure. An information security program that is consistently administered across the
entire Agency is critical to its ability to sustain and maintain its ongoing operations. The Agency
must achieve an appropriate balance between providing safe public access to accurate
environmental information and protecting the information assets of the Agency. Region 9 is
fully compliant with the requirements of NIST S.P. 800-53.
4.6.1.1 Use of Computer Hardware and Software
The purchase of computer hardware and software by Region 9 and its contractors is regulated by
Regional Order R2100 Information Resources Management Hardware Policy and Regional
Order R2100.1 Information Resources Management Software Policy. Regional policies are
designed to ensure that computer hardware and software meet program requirements and are
consistent with the Agency-wide standards.
4.6.1.1.1 Assessments of Impacts of Hardware and Software Changes
Most requests for computer system development, maintenance and enhancements are initiated by
clients in the program offices. ISB works closely with customers to determine their needs,
options and implementation schedule.
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4.6.1.1.2 Development of Software
Software applications developed in Region 9 are limited in scope. They are primarily user-
oriented and not expected to be shared outside the Region. Database applications are developed
using existing software only. An example is the Lotus Notes Quality Assurance Management
System (QAMS), which was a document tracking system developed by ISB for the QAB, and is
no longer maintained in the Region. The QAMS database was managed by the QAB as a read-
only database. Regional personnel are discouraged from developing their own software. The
development process includes the following steps:
Meetings with the user to determine user needs
Development, validation, and verification of the
user documentation
Preparation by the developer of a manual on the
Feedback from the user(s)
4.6.2 Standards for Computer Generated Data
Regional IRM data standards are consistent with Agency-wide standards. Regional contracts
require conformance to the Regional and Agency standards for hardware, software, and data
delivery format. Division justifications for computer related purchases require the ISB
concurrence. The monitoring of compliance is the responsibility of POs.
4.6.3 Regional Environmental Data Storage and Retrieval
Some monitoring data on individual computers are part of databases developed by HQ program
offices (STORET or its successor, the Water Quality Exchange (WQX) and the Air Quality
System [AQS]), while others are developed for specific users (e.g., Superfund contractor data
from remedial investigations). The database software includes QA routines. These routines are
assumed by the user to be adequate for the intended use of the database. The responsibility for
quality control of data entry and corrections belongs to the program office or division that
maintains the databases.
4.6.4 Geographic Information Systems
The Geographic Information Systems (GIS) Center is part of ISB. GIS policy guidance is
found at www.epa.gov/frs/gis-applications.
The GIS Center follows guidance contained in the following documents:
OMB Circular A-16, Coordination of Geographic Information, and Related Spatial Data
Activities (www.whitehouse.gov/omb/information-for-agencies/circulars/)
OMB Circular A-130, Management of Federal Information Resources
(www.whitehouse.gov/omb/information-for-agencies/circulars/)
Latitude/Longitude Data Standard
(www.exchangenetwork.net/standards/Lat Long Standard 08 11 2006 Final.pdf)
application; preparation and delivery of
development process
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EPA National Geospatial Data Policy: (www.epa.gov/geospatial/epa-national-
geospatial-data-policy)
Global Positioning Systems - Technical Implementation Guidance (nepis.epa.gov)
Guidance for Geospatial Data Quality Assurance Proj ect Plans
(www.epa.gov/fedfac/guidance-geospatial-data-quality-assurance-proiect-plans
Geospatial Metadata Standards (www.fgdc.gov/metadata/geospatial-metadata-
standards)
National Geospatial Data Policy Procedures for Geospatial Metadata Management
(www.epa.gov/geospatial/national-geospatial-data-policy-procedure-geospatial-
metadata-management)
The GIS Center uses the following data and GIS tool:
EPA Metadata Editor (www.epa.gov/geospatial/epa-metadata-editor)
Scribe: Environmental Field Data Capture Tool (www.ertsupport.org/Scribe)
4.7 Laboratory Program
4.7.1 Mission
The Region 9 Laboratory is a full-service state-of-the-art facility located in Richmond, CA
specializing in chemical and biological analysis and field sampling services. The mission of the
Laboratory is to provide quality analytical data in support of EPA regional and national programs
including hazardous waste, water, air, pesticides and toxics. It primarily supports the activities
of the Superfund program, for which it performs analyses generally not available through the
CLP.
In addition to non-routine analytical analyses, the Laboratory develops expertise and analytical
techniques to support specialized regional needs. The Laboratory also provides technical support
and training to internal and external laboratories and programs.
The Laboratory has the capability to analyze all types of environmental samples, including air,
water, soil, solid and liquid wastes, dust and biota (avian, fish and mammalian tissue). Analyses
include general inorganic chemistry, metals, volatile organic compounds, semi-volatile organic
compounds, PCBs and pesticides. Biological analyses include toxicity testing and
microbiological testing. The Laboratory also offers a variety of field services, including field
sampling, and field audits.
4.7.2 Facilities
The Laboratory maintains a 40,000 square foot facility located on the grounds of the University
of California's Richmond Field Station. The Laboratory employs 30-35 scientists, including
EPA staff and ESAT contractor staff.
4.7.3 Delivery of Laboratory Services
Before samples are analyzed in the Laboratory, a QA planning document is prepared by the
requester, and is then reviewed and approved by the QAB. The written plan contains the
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requester's analytical needs, which are communicated electronically to the Laboratory on a
"Request for Analysis" Form. The form is submitted to the Regional Sample Control
Coordinator who enters the information into a database for tracking purposes.
4.7.4 Laboratory Quality Assurance Organization
QA activities are implemented under the leadership of the Laboratory's QA Officer. S/he is
assisted by the QA Coordinator for the ESAT contract, operating under a task directive under the
contract.
4.7.5 Laboratory Quality Assurance System
The Laboratory is committed to monitoring and optimizing its performance through a variety of
activities. The Laboratory's QA Program is documented in its QA Plan, which is reviewed and
approved by the QA Office every three years or each time a revision is prepared.
Components of the Laboratory's QA system include document and record control; improvements
and preventive actions; ethics and data integrity procedures; Corrective Action Reports,
highlighting quality assurance issues that require investigation and correction; Discrepancy
Forms, documenting QC analytical problems of a more routine nature; external and internal
audits; single blind and split PE samples; and thorough review of all data generated by the
Laboratory prior to issuance of the final report.
The Laboratory routinely analyzes QA/QC samples and with field samples to determine
laboratory performance. The specific QA/QC requirements vary with the method, but generally
include the analysis of blanks, matrix spike/matrix spike duplicate samples, and laboratory
control samples with each batch, along with a low level quantitation check and calibration
checks. Other requirements may be specified in the appropriate SOPs or QA planning
documents. All laboratory analyses and other processes are described in standard operating
procedures. SOPs for routine activities are prepared, reviewed, and updated as needed. The
responsibility for review and approval of Laboratory SOPs rests with the Chemistry Team
Leader, the Biology Team Leader, the Laboratory QA Officer, and the Laboratory Director.
Data that the Laboratory generates are reviewed by the ESAT contractor, senior EPA personnel
and, in selected instances, the Laboratory QA Officer. The Laboratory Director signs all final
reports.
The Laboratory is audited by the State of Oregon in fulfillment of the requirements for
accreditation by The National Environmental Laboratory Accreditation Conference Institute
(TNI) every two years. The QAB performs quality system audits of the Laboratory in alternate
years.
4.8 Field Operations
On February 2, 2017 Region 9 implemented the Quality Assurance Field Activities Procedure
(QAFAP). The ten field guidelines were developed by the Region and are based on Agency
quality-related and ISO-17025 accreditation requirements. The QAFAP Guidelines are
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applicable to all organizations within Region 9 that conduct inspections/investigations and/or
collect environmental samples and measurements in the field.
The Field Operations Lead or Point of Contact (POC), oversees the implementation of this
system in Region 9. The POC conveys information and training materials within Region 9 and
assists each unit conducting field activities to implement the FOG Guidelines.
(www.epa.gov/region9/enforcement). The QA Manager represents the Region on the national
FOG technical group and works with the POC and the Region 9 Laboratory QA Officer to
support this effort.
4.8.1 Organization, Roles and Responsibilities
4.8.1.1 Regional Point of Contact/Implementation Coordinator
The Regional Point of Contact/Implementation Coordinator (POC/IC) is responsible for
coordinating the development and implementation of the field operations management system
across all Divisions and reports directly to the Enforcement and Compliance Assurance Division
Deputy Director.
4.8.1.2 Division Points of Contact
The Division Points of Contact (DPOCs) have the technical knowledge to assist their
organization with the implementation of the FOG Guidelines and development of SOPs. DPOCs
serve on the Regional FOG Implementation Workgroup led by the Region POC/IC. These
individuals may also assist in training their organization's staff.
4.8.1.3 Field Inspectors and Personnel
Region 9 field inspectors and personnel (e.g., project managers, field staff in the Region 9
Laboratory, on scene coordinators) are responsible for having an approved standard operating
procedure (SOP) as well as following other relevant QA planning requirements discussed in this
document prior to conducting field activities.
4.8.1.4 Subject Matter Experts
Subject Matter Experts (SMEs) are personnel competent, experienced, and knowledgeable in
matters relating to the procedure, standard, guidance or other subject matter relating to the FOG.
They serve on an organization-specific workgroup for FOG implementation. The RQAM is one
of the subject matter experts.
4.8.1.5 Document Control, Records Management and Equipment Custodian
Depending on the size, structure, and complexity of the organization, additional personnel may
be required to perform these duties if there is no such position in the current organization.
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4.8.1.6 Overarching Management System Procedures
The QAFAP Guidelines consist of ten main categories. Each DPOC will work within his/her
Division to develop management system procedures including:
Document Control includes the preparation, review, approval, issuance, revision,
revocation and archiving of SOPs and identifies a person to manage all SOPs.
Personnel and Training outlines the requirements for the education, training, knowledge,
and experience that qualify the employee to conduct field activities, including Health &
Safety Requirements under EPA Order 1440.21 and requirements under EPA Order
3500.12 (Employee Credentials).
Records Management requires that field teams maintain a records management system
suited to their particular circumstances and complies with applicable Federal, Agency and
Regional records management regulations and retention schedules.
Field Documentation describes the procedures to document field activities relating to data
entered into field notes, logbooks, photo logs, digital photos and mobile electronic units.
Reports summarize results of field activities, including compliance inspections and
contain the minimum requirements that are to be incorporated into all field inspection
reports regardless of the Division and/or Program.
Sampling and Environmental Data Management includes the identification,
transportation, handling, protection, storage, and retention of samples and other evidence
(measurements, or documentation such as field notes, instrument charts, laboratory
reports, photographs, or technical reports) collected in the field.
Field Equipment Logs track the record of maintenance, calibration, verification,
inventory, and records of equipment used for field sampling and measurement activities.
Field Inspections and Investigations procedures are found in national program guidance
documents (i.e., RCRA Inspector Guidance, NPDES Compliance Inspection Manual,
etc.). The Region may develop one procedure for Inspections/Investigations to
incorporate these guidance documents by reference or the Divisions/organizations may
choose to develop specific procedures for their inspections/investigations.
Internal Audits are conducted periodically by field teams to verify that their operations
comply with the guidelines.
Corrective Actions address the findings from internal audits through corrective actions
whenever nonconformities are identified.
4.9 Standard Operating Procedures
Data collection procedures may be standardized and published as written protocols for inclusion
by reference in QAPPs, SAPs, FSPs, contracts and similar documents, and for use as guidance
and technical assistance documents. SOPs are prepared using Guidance for the Preparation of
Standard Operating Procedures (G-6) (EPA/600/B-07/001, April 2007). The responsibility for
1 EPA Order 3500.1 A1 Training and Development for Individuals Who Lead Compliance Inspections/Field
Investigations, December 23, 2002.
2 EPA Order 1440.2 Health and Safety Requirements for Employees Engaged in Field Activities, July 12, 1981.
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preparing, updating and approving SOPs rests with the party using them.
Routine activities that are performed by a Division or Office on a regular basis, especially if they
are complex and/or sequential, may be usefully described in an SOP. This will ensure
consistency of application, accountability for changes and will reduce data gaps that might
otherwise occur during a change in personnel or reorganization. The QAB reviews internal
SOPs as requested.
Region 9 does not currently have an overarching policy for preparing, reviewing and approving,
maintaining and replacing SOPs. A Region 9 policy/order will be put in place to govern SOPs
for field operations. The Region 9 Laboratory has an SOP policy, which is described in the
Laboratory QA Plan and lists the Laboratory SOPs on the Region 9 Laboratory intranet
webpage. The QAB may review these documents as part of its review of QA planning
documents or audits it conducts, but it does not approve SOPs. The Region 9 Laboratory also
has an extensive collection of SOPs, including both field and analytical procedures, available
upon request.
4.10 Measurement Quality Objectives/Data Quality Indicators Tables
The Region 9 QAB has developed Measurement Quality Objective (MQO) tables of data quality
indicators (DQIs) for most of the more commonly requested analytical methods. These may be
used by grantees or Region 9 staff in procuring requests for analytical services. The tables
specify detailed calibration and QC requirements for each analytical method, including quality
control limits and corrective action procedures. DQI tables are available on the Region 9 quality
assurance web page (www.epa.gov/region9/qa/datatables).
4.11 Information Quality Guidelines
The Region 9 Office of Public Affairs follows the Guidelines for Ensuring and Maximizing the
Quality, Objectivity, Utility, and Integrity of Information Disseminated by the Environmental
Protection Agency (www.epa.gov/quality/informationguidelines/) in reviewing information
from all Divisions that is disseminated to the public through its communication networks. The
review process ensures that such products meet the performance goals stated in the guidance:
Dissemination of information should adhere to a basic standard of quality, including
objectivity, utility, and integrity.
Principles of information quality should be integrated into each step of EPA's
development of information, including creation, collection, maintenance, and
dissemination.
Administrative mechanisms for correction should be flexible, appropriate to the nature
and timeliness of the disseminated information, and incorporated into EPA's information
resources management and administrative practices.
Following the national Information Quality Guidelines, the QAB, OP A and ISB have developed
a Regional policy, the Pre-Dissemination Review, that outlines procedures the Region follows in
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conformance with the national policy
(http://intranet.epa.gov/9online/sites/communications/pdf/pre-dissemination-review.pdf).
4.12 Peer Review
Peer review is a documented critical review of a specific Agency scientific and/or technical work
product. Peer review is conducted by qualified individuals (or organizations) who are
independent of those who performed the work, but who are collectively equivalent in technical
expertise (i.e., peers) to those who performed the original work. Peer review is conducted to
ensure that activities are technically adequate, competently performed, properly documented, and
consistent with established quality principles. EPA's peer review process is described in the
Peer Review Handbook, 3rd Edition (EPA/ 100/B-06/002). Work products requiring formal peer
review may be entered in the Science Inventory (https://cfpub.epa.gov/si/). The Regional
Science Liaison is the Point of Contact for Peer Review and the Science Inventory for Region 9.
An annual call for entries is sent out on the R9 Communicator.
5.0 Assessment
5.1 Overview
The audit is the standard mechanism for performing oversight of the effectiveness and adequacy
of a quality system of a program or project collecting environmental measurements. During an
audit, the data quality needs of the program as articulated in the quality assurance planning
documents are compared against the implementation information and quality of the data
obtained.
The audit process is expected to identify strengths and weaknesses; suggest corrective actions to
be taken to resolve problems; facilitate the initiation of changes to enhance the QA program;
serve as a vehicle for providing technical assistance; enhance awareness and understanding of
QA/QC policies and procedures; and provide a measurement of the effectiveness of QC in
assuring the quality of data. Audits or reviews are scheduled and performed by the QAB on
Regional programs as needed and as resources allow.
QAB staff responsible for conducting these audits are trained to perform these reviews and have
experience in performing the types of environmental measurements. While most Region 9 QAB
staff have taken and, in some cases, provided, training in performing audits, when regulations or
assignments change or new collection activities are introduced, they are strongly encouraged to
take training in auditing the new area. This is reflected in their Individual Development Plans.
Staff performing audits must complete ethics training and financial disclosure statements, if
required, each year to ensure that they are not aware of any real or perceived conflict of interest
in the work being assessed.
An auditor may gather information in any form, through interviews and observations, and
inspection of records and data tracking documentation. The QAB develops findings during an
audit, presents preliminary findings during the exit briefing and prepares a draft report, ideally
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within a month of the audit. The auditor may consult with the audited agency to clarify issues or
discuss potential corrective actions before the final report is issued. The results of the
communication may be included in the report. Depending on the nature of the findings, the QAB
may follow up to ensure that the corrective action plan is being implemented or may review the
status of the implementation at the next scheduled audit. If there is a question about the findings,
the issue may be raised to the next level of organization management up to and including the
Regional Administrator. The approach for each type of audit is presented in Table 1.
Descriptions of each type of audit is found in the following sections.
Table 1. Region 9 QA Ol
'fice Audits
Type of Audit
Frequency
Assessment
tool used
Reports
Division within the
Regional Office review
of QA requirements
Not regularly
scheduled
Interview and
checklist
Division
Director or
designee
State QSRs*
Not regularly
scheduled
Audit checklist
Executive
Director
Air PQAO TSA
Every three years
Audit checklist
District
Executive
Regional Laboratory
Every two years
Audit checklist
Laboratory
Director
Other laboratories
On demand
Audit checklist
Project
Manager
Performance
Evaluation Samples
As per
recommendation in
QAPPs and on demand
Review of
reported results
Project
Manager/
Superfund, Air
Districts,
DMR-QA
reports
Data
Verifi cati on/Vali dation
As per
recommendation in
QAPPs
Review of
reported results
Project
Manager
Field system
As per FO guidance
Audit checklist
FOPOC
Field
As per FO guidance
Audit checklist
FOPOC
*Prior to 2005, State QA programs were audited on an ad hoc basis. Since 2005, the QAB has focused on reviewing
State Quality Management and Program Plans. With many of those reviews in the process of being up dated, we are
developing a process and a schedule for conducting state MSRs. Travel restrictions limit most of these MSRs to
desk audits. Restricted travel to perform air districts audits, as required every three years by the Clean Air Act, has
led to the substitution of in person by desk top audits for every other audit in the cycle. Using this process, however,
along with follow-up Performance Evaluation Samples, the QAB is able to gather current information about quality
management systems throughout the Region.
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5.2 Assessment Tools
The assessment tools used by the Region are quality systems review (QSR), technical systems
audit (TSA), performance evaluation samples (PES) and data validation.
5.2.1 Quality System Reviews (QSRs)
A Quality Systems Review (QSR) is an evaluation of the management of the QA program being
implemented in the Region, States and some Tribes, including the level of management support,
systematic planning and planning documentation, data quality assessment, internal audit
procedures, and the effectiveness and consistency of corrective actions.
The QAB may conduct QSRs to determine whether the documented quality system is being
implemented and to evaluate its effectiveness. The management and technical activities for
ensuring the collection of data of known quality are reviewed, along with the roles,
responsibilities, and authorities of the individuals implementing the system.
Regional QSRs are conducted in accordance with the Guidance for Preparing, Conducting, and
Reporting the Results of Management Systems Reviews (EPA QA/G-3, March, 2003). In
fulfillment of the TNI laboratory accreditation requirement, an MSR is conducted every year at
the Regional Laboratory. An QSR may be triggered by serious or persistent quality control
failures or non-compliance identified through routine and standard field/lab audits and other
quality checks. As States update their QMPs and QAPPs, the QAB, working with the state QA
Officers, will evaluate the need to develop a schedule to conduct QSRs of their quality systems.
5.2.2 Technical Systems Audits (TSAs)
A technical systems audit (TSA) evaluates aspects of the actual performance of specific projects
or data generation activities, implementation of QA planning documents and evaluation of field
and laboratory activities.
In accordance with Federal regulations at 40CFR Part 58, EPA regional offices are required to
conduct TSAs of each Primary Quality Assurance Organization (PQAO) at least once every
three years. A PQAO is a monitoring organization or a coordinated aggregation of such
organizations that is responsible for a network of air monitoring stations that share data quality
standards. Conducting a TSA is one of the ways that EPA provides oversight to ensure air
quality data collected by state and local agencies meet EPA's data quality requirements.
In Region 9, there are eleven PQAOs which include: California Air Resources Board, Bay Area
Air Quality Monitoring District, South Coast Air Quality Monitoring District, San Diego Air
Pollution Control District, Nevada Division of Environmental Protection, Washoe County, Clark
County, Hawaii Department of Health, Arizona Department of Environmental Quality, Maricopa
County and Pima County. Four Tribes are also PQAOs: Morongo, Pechanga, Gila River and
Salt River.
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Technical System Audits (TSAs) of state air PQAOs are conducted jointly by the Air and
Radiation Division's Air Quality Analysis Office (AQAO) and the QA Branch. Each district is
audited once every three years. Because there are 15 PQAOs, and considering staff time and
travel resource limitations, desk top audits are conducted on alternate TSA cycles. The AQAO
and QAB perform equipment audits of other air monitoring programs as requested.
The AQAO Office oversees the ESAT technician who conducts compliance audits of equipment
used by air districts for the Air National Performance Audit Program (NPAP) and Performance
Evaluation Program (PEP) on a regular basis and as needed. The QAB continues to provide
technical support as requested.
Field audits are conducted by staff at the Region 9 Laboratory; the QAB may participate or
conduct the audit as requested by the Laboratory field team. The QAB conducts field audits of
vapor intrusion investigations for the Superfund Division upon request.
The Laboratory and QAB staff may audit laboratories working for Responsible Parties, Federal
Facilities, Resource Conservation and Recovery Act (RCRA) owner/operators, National
Pollution Discharge Elimination System (NPDES) dischargers and Superfund contractors upon
request or as needed.
Laboratory certification audits of State, Territory, and Tribal drinking water laboratories are
conducted by Regional Laboratory certification officers once every three years. Procedures and
checklists for these audits are defined in the laboratory certification manuals published by the
Office of Ground Water and Drinking Water's Technical Support Center, Cincinnati.
Since the NELAC Institute (TNI) became a completely private organization, neither QAB or
staff at the Regional Laboratory participates in accrediting body evaluations.
For both field and laboratory audits, prepared reports describe when, how and by whom the audit
was conducted, what specific procedures were reviewed, a summary of the findings, and
recommendations for corrective action. The audit report is transmitted to the audited office, the
program manager, and the PO, as appropriate. The audited organization is responsible for
ensuring that prompt corrective action takes place. Follow-up activities vary according to project
objectives.
5.2.3 Performance Evaluation Samples (PEs)
Performance evaluation samples (PEs) are samples of the chemical of interest in a known
concentration that may be sent as a known performance sample or an unknown environmental
sample to verify the ability of a laboratory to produce reliable data.
Performance evaluation samples are used to assess laboratory capability and performance prior
to contract award and on an on-going basis as an external means to evaluate laboratory
performance and ensure data reliability. Federal facilities are required to use PEs on a regular
basis, as indicated in planning documents. For EPA-lead sites, the EPA contractor must use
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them, as indicated in a Region 9 approved QAPP.
The QAB provides single blind (identification of performance sample of unknown
concentration) or double blind (sample is not identified as a PE and is prepared using media
resembling the site) audit samples to evaluate laboratory performance. The QAB recommends
the use of PEs to evaluate the capability of a laboratory to perform the requested analysis and to
determine whether laboratory performance is consistent for on-going projects. Laboratories also
participate in regularly-scheduled EPA-wide Water Supply and Water Pollution (WS/WP) PE
studies. The Regional Laboratory uses PEs in a self-evaluation program.
5.2.4 Data Review: Verification and Validation
Data review is a continuum of processes, including review or verification and validation, to
determine whether data have been generated according to specifications, satisfy acceptance
criteria, and are appropriate for their intended use. Data verification evaluates completeness,
correctness, and compliance of data to defined methods, procedures, and control limits. Data
validation expands verification to assess the data and the methods used against project
objectives, and may point out areas needing corrective action in future efforts. In Region 9, the
terms "verification and "review" may be used interchangeably to cover a range of processes,
according to a graded approach.
5.2.4.1 Responsibility for Data Review
The QAB performs data review primarily for Superfund Fund-lead projects and through
contractors, although contractors do not evaluate the usability of data for intended uses. Upon
request, QAB staff may perform data validation and oversight of data reviews for other projects
from the Superfund Division (e. g., Potentially Responsible Party-lead, State-lead, Federal
Facility-lead, or Brownfields) or other Divisions. All other data review defined in QA planning
documents is performed by the project team. The EPA project manager is responsible for
making the final determination as to whether the data may be used for their intended purpose; the
QAB provides technical assistance as requested.
5.2.4.2 Tiered Data Review
The QAB follows a data evaluation system in which the level of effort of the review increases
with successive tiers. The tier is appropriate to project DQOs and financial and temporal
resource constraints.
Tier 1 is a relatively streamlined review of quality control (QC) information. Data review may be
limited to reviewing reported QC results against acceptance limits, possibly using a software
program, with no review of the raw data. The inherent risk of mischaracterizing data quality
must be assumed to be acceptable for project needs.
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Tier 2 is a targeted review of specific components of the data package, typically specific samples
or analytes of particular interest. Tiers 1 and 2 are suited to projects that have sufficient
historical data.
In Tier 3, a full data review is performed, including but not limited to method details, instrument
printouts and logs, including calculation checks. Tier 3 reviews are intended to evaluate the
legal defensibility of the data. For Superfund projects, Tier 3 validation is performed using the
Superfund Functional Guidelines for Evaluating Laboratory Data (OSWER 9240.1-46, July
2007) for organic and inorganic analyses generated through the Contract Laboratory Program
(CLP). Although the guidance is used principally to validate Superfund data, it may be used in
other programs.
6.0 Quality Improvement
The QAB is committed to continual improvement of the Region 9 Quality System. The staff
meets regularly as an office and as needed in designated or self-identified teams to discuss
quality issues related to projects and the quality system in general. The Office may identify
areas where a general policy needs to be established or changed.
In addition, the QAB has initiated and implemented the EPA Lean Management System (ELMS)
to track actions as they move through QAB's process in order to respond and resolve challenges
quickly and thoroughly using Lean principles and tools. QAB's current project tracks the time it
takes for eligible State and Tribal QAPPs to be approved by the QAB. The QAB goal is to
review and approve eligible State and Tribal QAPPs in 60 days, not counting the time the
grantee takes to respond to comments. Progress in meeting the goal is tracked in a National
performance measure maintained by the Agency's Quality Staff.
6.1 Planning documents
The QA Office is committed to supporting internal and external efforts to create QA planning
documents that are dynamic and useful. We believe that the process of writing the document
should help the author articulate management, program and project objectives that are clearly
stated and consistently supported. QA documentation should be familiar and available for
reference to all levels of an organization. To facilitate that effort, the QAB has developed a
number of specific templates that are posted on the Agency's quality website. Staff are available
to provide further assistance.
6.2 Training
The QAB supports continuous training for staff in quality assurance, in technical subjects related
to their area of expertise and in new areas of interest or of emerging importance to the Agency
and to Region 9 Divisions. Trainings are held at the request of the media divisions or provided
to grantees as needed.
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6.3 Audits
The Clean Air Act requires EPA to audit air districts within the Region every three years. The
QAB continues to collaborate with the Air and Radiation Division's Air Quality Analysis Office
to complete the QA elements of Technical System Audits, contribute findings to reports, and to
follow up on corrective action plans on a regular schedule
6.4 Standard Operating Procedures
The QAB has a set of SOPs that describe various office activities. They are peer reviewed by
staff and approved by the RQAM. SOPs that have been superseded are archived. The QAB
SOPs will be posted on the Region 9 Quality Assurance webpage.
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APPENDIX A: Quality Assurance Branch Staff Qualifications
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Quality Assurance Branch
Grade Series
Responsibilities
Years in QA
401 Supervisory Life
Scientist
Manages QAB
2
1320 Chemist
Superfund and RCRA
reviews and audits, ESAT
COR for data validation
-20
1301 Environmental
Scientist
Superfund and Water
review, groundwater
expertise, website manager
>20
1301 Environmental
Scientist
Air QA reviews, audits,
Superfund and Air training,
vapor intrusion expert
-20
1301 Environmental
Scientist
Air QA reviews, audits,
Superfund groundwater,
Water ATP coordinator
>20
1301 Environmental
Scientist
Superfund, Water QA
reviews, training, audits,
statistics, sampling design
>20
819 Environmental
Engineer
Air QA reviews, audits,
Superfund technical
assistance, vapor intrusion
expert
-3
28 Environmental
Protection Specialist
ESAT COR, Brownfields
QAPP reviewer
-3
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APPENDIX B: Organization of the Laboratory Services and Applied Science
Division
-------
Environmental Protection Agency - Region 9
Laboratory Services & Applied Science Division
Immediate Office
(415) 947-8720
Duane James - Director
LSS-1
Matthew Small - ORD Science Liaison
Regional Laboratory
Peter Husby
LSS-2
Quality Assurance Branch
Audrey Johnson
LSS-3
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APPENDIX C: Region 9 Organization
-------
Tribal, Intergovernmental
& Policy Division
(415) 947-8721
Laura Ebbert
TIP-1
Southern California
Field Office
(213) 244-1800
Steven Leonido-John - Director
Environmental Protection Agency
Region 9
Office of the Regional Administrator
(415) 947-8702
John Busterud - Regional Administrator
Deborah Jordan - Deputy Regional Administrator
ORA-1
Water Division
(415) 947-8707
Tomas Torres
WTR-1
Air & Radiation Division
(415) 947-8715
Elizabeth Adams
AIR-1
i
i
Public Affairs Office
(415) 947-8702
Mike Alpern
OPA-1
EEO/Diversity Manager
(415) 947-4284
Gina Edwards
i
Office of Regional Counsel
(415) 947-8705
Sylvia Quast
ORC-1
Superfund & Emergency
Management Division
(415) 947-8709
Enrique Manzanilia
SFD-1
Enforcement & Compliance
Assurance Division
(415) 947-8700
Amy Miller
ENF-1
Land, Chemicals &
Redevelopment Division
(415) 947-8704
Jeff Scott
LND-1
_L
Laboratory Services &
Applied Science Division
(415) 947-8720
Duane James
LSS-1
I
M ission Support Division
(415) 947-8709
Kerry Drake
MSD-1
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APPENDIX D: Navajo Abandoned Uranium Mine QMP
-------
EPA Region IX
Navajo Abandoned Uranium Mines Program
Quality Management Plan
September 1, 2020
-------
TABLE OF CONTENTS
CONCURRENCES AM) APPROVALS iv
1 PURPOSE AM) BACKGROUND 1
1.1 Introduction 1
1.2 Definition of the Problem and Background Information 4
1.2.1 Program Description 4
1.3 Roles and Responsibilities 4
1.3.1 Tribal Land Cleanup and Remedial Support Branch Manager 7
1.3.2 Proj ect Manager 7
1.3.3 Quality Assurance Manager 8
1.3.4 Data Management Team 8
1.3.5 Office of Radiation and Indoor Air 8
1.3.6 Office of Land and Emergency Response 9
1.3.7 Partner Agencies 9
1.4 NAUM Standard Quality Practices 11
1.4.1 Review and Approval of QAPPs 11
1.4.2 Field Oversight Tools and Considerations 15
1.4.3 Validation of Data 15
1.4.4 Laboratory Competency 17
1.4.5 Continuous Quality Improvement 17
1.4.6 Deterrence of Fraud 18
1.5 Quality Objectives and Criteria for Measurement Data 19
2 DATA GENERATION AND ACQUISITION 20
2.1 Sampling Process Design 20
2.1.1 Data Quality Obj ectives 20
2.1.2 Data Quality Indicators 20
2.1.3 Measurement Quality Objectives 22
2.2 Field Sample Collection Methods 24
2.3 Laboratory Analytical Methods 25
2.4 Quality Control Requirements 25
2.4.1 Field Sampling Quality Control 25
2.4.2 Laboratory Quality Control 25
2.5 Instrument and Equipment Testing, Inspection, Maintenance 26
2.6 Instrument and Equipment Calibrations and Frequency 26
2.7 Gamma Scanning Field Measurements 27
2.8 Non-Direct Measurements 27
2.9 Gamma Data Validation Considerations 27
3 ASSESSMENT AND OVERSIGHT 37
3.1 Assessment and Response Actions 37
3.1.1 Audits 37
3.1.2 Nonconformance and Corrective Actions 38
3.1.3 Reconciliation of Data with Data Quality Objectives 38
3.2 Field Oversight 39
3.2.1 Types of Field Oversight Activities 39
3.2.2 Minimum Field Oversight Goal 40
EPA Region 9
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3.2.3 Field Oversight Responsibilities 42
3.2.4 Common Concerns for any Oversight Event 43
3.2.5 Resources for Planning and Implementing Field Oversight 44
3.3 Reports to the Project Manager 46
4 DATA VALIDATION AM) USABILITY 46
4.1 Data Review and Validation 46
4.2 Data Review and Validation Procedure 46
4.3 Data Usability Assessment 47
RELEVANT PROGRAM GUIDANCE 49
REFERENCES 50
ACRONYMS AM) ABBREVIATIONS 51
EPA Region 9
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LIST OF TABLES
Table 1-1 - EPA NAUM Program Key Responsibilities
Table 1-2 - Partner Agencies
Table 1-3 - Responsibilities for Implementation of the Review and Approval Process Table
1-4 - NAUM QAPP Approval Guide
Table 1-5 - Data Validation Responsibilities
Table 2-1 - Typical NAUM Laboratory Methods
Table 2-2 - Typical Data Quality Indicators for Soil and Sediment Samples
Table 2-3 - Typical Data Quality Indicators for Water Samples
Table 2-4 - Typical Data Quality Indicators for Gamma Scanning (Under Development)
Table 3-1 - Program Minimum Oversight Goal and Responsibility
Table 3-2 - Field Oversight Responsibilities
Table 3-3 - Noted Problems in CERCLA Programs and Oversight Considerations
LIST OF FIGURES
Figure 1-1 -NAUM QAProgram Overview
Figure 1-2 - Organization Chart
Figure 2-1 - Typical Analytical Techniques
LIST OF APPENDICES
Appendix A: QAPP Signature Block Template Examples
Appendix B: QAPP Review Checklist
Appendix C: NAUM Field Surveillance Checklist
Appendix D: Radiochemical Data Validation SOP
Appendix E: Gamma Scanning Checklist (Under Development)
EPA Region 9
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I V \ Ri»iun 9
INavajo Abandoned I r:iilium Minis Program
<>u;ilil\ M;m.imnK uf Plan
Scptctulicr 1| 2020
CONCt RRKNCTS AND APPROVALS
W ill Duncan
Assistant Director, Tribal Land Cleanup anci Remedial Support Branch
Stature: WILL DUNCAN M D,«e;
-BW
\udrc) ! . Johnson
Manager, Quality Assurance Branch
A1 iH rmt I Digitally signed by
#^uui cy l. Audrey I Johnson
Signature: jQ^p^on 2020.09.C2 Date:
1fJ»C34L3(s -0700
John \\ . liustcrud
Regional Administrator
JOHN
Si«n;.li.rv: RUSTERUD
Zgassr**""
mm-issmm1 jaw Date
«r«r
EPA Region 9
Navajo Abandoned Uranium Mhu-s I'n .grain
Page iv
Quality Management Ban
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Standards, methods, and approaches described in this Quality Management Plan are intended for
use by U.S. Environmental Protection Agency personnel for all data collection efforts for
Superfund cleanup projects at Navajo Abandoned Uranium Mine Program sites.
EPA Region 9 Quality Management Plan
Navajo Abandoned Uranium Mines Program
Page iv
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PURPOSE AND BACKGROUND
Introduction
This Quality Management Plan (QMP) describes practices for environmental data collection for
cleanup decisions on United States Environmental Protection Agency (EPA) Region 9 work on
Navajo Abandoned Uranium Mine (NAUM) Program sites. This QMP is a program-specific
amendment of the EPA Region 9 QMP and describes a system to ensure that data-driven decisions
meet agency requirements for:
Scientific integrity
Legal defensibility
Transparency
Accountability
Efficiency
The principal components of the system described are planning (e.g., scoping meetings and Quality
Assurance Project Plan [QAPP] development), verification (e.g., data validation and audits), and
documentation. Policies or specifications that facilitate implementation of work under this QMP
are provided. Quality assurance (QA) policies, when applicable, apply to all data generation and
collection activities, and the burden is on the project team to evaluate and modify any element of
the quality system as necessary on a site-by-site basis.
This document not only supplements the EPA Region 9 QMP but also provides additional
information typically found in a QAPP. The functions of the QMP and QAPP have been combined
into one comprehensive document for efficiency and to accomplish the QA objectives of the
NAUM Program. One major focus of this QMP is to describe the radiological environmental data
collection and analysis practices of the NAUM Program in compliance with EPA QA policies.
This effort supplements the chemical analysis QA already included in the EPA Region 9 QMP.
Key objectives of this QMP include:
Ensuring that the data are of sufficient quality to support the project objectives and the data
end uses. This QMP presents the practices, program organization, functions, and QA and
quality control (QC) requirements designed to meet the objectives of the NAUM Program.
Providing guidance that establishes the analytical protocols and documentation
requirements to ensure that data are collected, reviewed, and analyzed in a consistent
manner.
The elements of the NAUM QA program are presented in Figure 1-1 and defined in EPA QA
guidance. This QMP focuses on the implementation of these elements when performing cleanup
activities on the Navajo Nation. The NAUM Program is in the process of developing
implementation documents as resources for Remedial Project Managers (RPMs) and On-Scene
Coordinators (OSCs) to effectively carry out a defensible QA program. The project documentation
column in Figure 1-1 lists the documents necessary to ensure that the required QA steps have been
carried out appropriately.
Development of this first version of the NAUM QMP focuses primarily on the investigation phase
of NAUM cleanup since most of the field work is currently focused on the collection of data for
EPA Region 9
Navajo Abandoned Uranium Mines Program
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investigation purposes. This QMP includes key implementation tools such as data quality indicator
(DQI) and measurement quality objective (MQO) tables, a field surveillance checklist, and data
validation standard operating procedure (SOP). Additional topics include NAUM-specific
guidelines on:
Review and approval of QAPPs
Field oversight
Validation of data
Laboratory competency
Continuous improvement
Deterrence of fraud
This QMP was developed with contractual support and then went through a subsequent review for
technical accuracy by experts under a different contractor. As part of the continuous improvement
process, this QMP is envisioned as a living document and will be revised and expanded to cover
additional topics such as a corrective action tracking system, an annotated QAPP review checklist,
and additional implementation tools. The QMP will be expanded to incorporate information
specific to data collection under the Navajo Nation Contaminated Structures Program and for site
clearances, such as data collected during the Final Status Survey.
EPA Region 9
Navajo Abandoned Uranium Mines Program
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Figure 1-1 - NAUM QA Program Overview
QA Category
QA Element1
EPA Region 9
NAUM
Quality Assurance
Program
Notes:
1.
DQO
EPA
EPA. 2002a. Guidance for Quality
Assurance Project Plans. EPA
QA/G-5, EPA/R-02/009.
December.
Data quality objective
U.S. Environmental Protection
Agency
NAUM Navajo abandoned uranium mine
QA Quality assurance
QAPP Quality Assurance Project Plan
SOP Standard Operating Procedure
Program
Purpose and
Structure
Data
Validation
Program
Guidance and
References
E Roles and Responsibilities
Definition of the Problem/
Background Information
| Quality Objectives/Criteria"
Special Training and Certs
Sample Process Design
Sampling Methods
Sample Handling
[ Analytical Methods
Quality Control
Equipment Testing
[ Equipment Calibration
Inspection/Acceptance
Non-Direct Measurements
Data Management
Field Oversight
h: Reports to Management
Verification Methods
Third-Party Data
L-C Reconciliation
References and Resources
Documentation / Record '
Assessment/Response Actions
I-C Data Review/Validation
1
EPA Region 9
Navajo Abandoned Uranium Mines Program
Page 3
Implementation
Documents and Tools
QA Management Plan
DQO Best Practices
QAPP Review Checklist
Field / Equipment SOPs
Field / Equipment Forms
Data Management Plans
and Tools
Project Documentation
Approved Quality
Assurance Plan
Training Records
Field Data and
Log Books
Completed SOP
Forms
r
\
Field Surveillance
Checklist
V
V
Assessment and
Oversight Findings
Data Validation/Gamma/
Lab SOPs
Lab Data Package
Data Validation
Report
Guidance
Documents
Quality Management Plan
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Definition of the Problem and Background Information
The Navajo Nation, roughly the size of West Virginia, encompasses more than 27,000 square miles
and extends into northeastern Arizona and parts of southeastern Utah and northwestern New
Mexico. Over 30 million tons of uranium ore were extracted during mining operations on or near
the Navajo Nation from 1944 to 1986 for developing the U.S. nuclear weapons stockpile and
supplying the nuclear power industry. Uranium mining activities no longer occur on the Navajo
Nation, but the legacy of these activities remains. More than 500 abandoned uranium mines
(AUMs) or mine claims remain on or near the Navajo Nation with more than 1,000 mine features.
Waste piles and other sources of contamination remain on many AUMs. Many structures and water
sources contain elevated levels of uranium, radium, and other radionuclides. Uranium and other
elements (selenium, arsenic, etc.) associated with mine and mill sites also occur naturally at
elevated levels in rock, soil, surface water, and groundwater across the Navajo Nation and the
broader Four Corners region. Health effects as a result of exposure to these elements can include
lung cancer, bone cancer, and impaired kidney function.
Program Description
EPA, other federal agencies, and the Navajo Nation are working together to address the legacy of
uranium mining and milling on the Navajo Nation. EPA Region 9's NAUM Program comprises
professionals within the Superfund and Emergency Management Division and draws support from
numerous colleagues within the region and throughout the agency. The NAUM Program uses
Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) authority
to oversee assessment and cleanup work at Navajo AUMs, coordinating with the Navajo Nation
Environmental Protection Agency (NNEPA), other Navajo agencies, communities, stakeholders,
and other federal partners. The goal of these efforts is to reduce the health and environmental risks
associated with past uranium mining activities and find long-term solutions to the remaining
uranium issues on Navajo lands.
Roles and Responsibilities
EPA NAUM Program personnel are responsible for the quality of work and must be
knowledgeable of the requirements, processes, capabilities, and tools utilized to accomplish tasks
at their site. Figure 1-2 shows the EPA NAUM Program organizational chart. The primary NAUM
program includes the RPMs, Community Involvement Coordinators (CICs), Project Officers
(Pos), and managers in the Tribal Lands Cleanup and Support Sections shown in the bright yellow
box below in Figure 1-2. This NAUM team is located in the Superfund and Emergency Response
Division, and is supported by technical support, Quality Assurance, legal, contracting, OSCs, and
other staff and managers in multiple Divisions throughout the region. Table 1-1 includes the roles
of key EPA positions within the NAUM Program for the purposes of QA.
EPA Region 9
Navajo Abandoned Uranium Mines Program
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Figure 1-2 - EPA NAUM Program Organization Chart
ORIA Office of Radiation & Indoor Air
OSC Oil-Scene Coordinator
PO Project Officer
RPM Remedial Project Manager
EPA Region 9
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Table 1-1 - EPA NAUM Program Key Responsibilities
NAl'M Program Supervisors
Ensure that adequate procedures are in place to address QA requirements in all applicable
program operations, including those delegated to other agencies
Ensure that resources needed to implement QA requirements are identified and provided
Ensure that QA training is available for RPMs and OSCs implementing the CERCLA
process at NAUMs
Ensure adequate QA reviews or audits are performed on a routine basis
Ensure an appropriate system to track and implement corrective actions is in place (to be
developed)
Coordinate NAUM QA matters with the RQAM to ensure that all QA policies and
methods are in accordance with EPA national and regional guidelines
Ensure routine assessment of QA needs occurs and that any identified improvements
needed are implemented, which may include revisions to the NAUM QMP, developing
new trainings, etc.
Collecting NAUM QA information for the RQAM for consolidation into the Region 9 QA
Annual Report and Work Plan
Facilitate opportunities for routine technical discussions among NAUM RPMs and OSCs
to ensure consistency between projects and continuous improvement in implementation
(see Section 1.4.5)
NAl'M Project Managers (UPM/OSQ
Ensure that all NAUM projects involving the generation of environmental data are
performed in accordance with the NAUM QMP
Review, comment on, and approve project-specific QAPPs for all NAUM projects
Perform QA reviews and oversight with assistance from the RQAM or other technical
experts as needed
Perform or arrange for QA audits as appropriate
Ensure individual corrective actions are taken based on recommendations contained in the
QA review findings report
Identify NAUM QA and QC needs and respond to problems or questions with assistance
of the RQAM or other technical experts as necessary
Identify NAUM QA training needs in coordination with the RQAM
Notes:
CERCLA
Comprehensive Environmental Response, Compensation, and Liability Act
EPA
United States Environmental Protection Agency
NAUM
Navajo abandoned uranium mine
osc
On-Scene Coordinator
RPM
Remedial Project Manager
RQAM
Regional Quality Assurance Manager
QA
Quality assurance
QAPP
Quality Assurance Project Plan
QC
Quality control
QMP
Quality Management Plan
EPA Region 9
Navajo Abandoned Uranium Mines Program
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Tribal Land Cleanup and Remedial Support Branch Manager
The NAUM Program is led by the Tribal Land Cleanup and Remedial Support Branch Manager.
The Branch Manager oversees two Tribal Lands Cleanup Sections, which include the two Section
Managers, RPMs, a Project Officer, and Community Involvement Coordinators. The Branch
Manager also oversees technical support staff and is supported by various program managers both
within the division and throughout the region, including:
Emergency Response
Quality Assurance
Contracting
Office of the Regional Council
The Section Managers maintain the authority, responsibility, and accountability for overall
program planning and implementation, contract utilization, and interaction with other partner
agencies.
Project Manager
EPA RPMs and OSCs manage specific projects within the NAUM Program. RPMs and OSCs
serve as the primary decision-maker and are responsible for establishing data quality objectives
(DQOs) while clarifying information necessary to successfully manage the site. RPMs and OSCs
are also responsible for directing operations associated with the project, working with agency and
contractor personnel to develop project teams with the appropriate level of technical input, as well
as ensuring the health and safety of project personnel. RPMs and OSCs oversee project QA,
environmental compliance, environmental sampling, environmental data management, records
management, and project delivery.
RPMs and OSCs are responsible for obtaining adequate support on projects using contractors or
program support staff, including:
Community Involvement Coordinators
QA Officer (QAOs)
Data management experts
Health and Safety Officers
Regional counsel
Health Physicists
Statisticians
Risk Assessors
Geologists
Ecologists
Biologists
Engineers
EPA Region 9
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Quality Assurance Branch
The Region 9 QA Manager is responsible for the implementation of the Region 9 QA Program
and Region 9 QMP, as well as defined responsibilities in the NAUM QMP, which include:
Coordinating with the NAUM Program Section Managers for QA support activities
Providing and interpreting agency QA policies and procedures
Jointly with Program Managers, developing, maintaining, and implementing processes to
ensure NAUM Program decisions are based on sound, defensible, and documented
information
Approving QAPPs, as appropriate, and Regional Contract QA requirements
Ensuring independent reviews of data quality are performed
Providing QA training on regional policies and procedures for EPA-implemented projects,
assignment of a QAO to work as an integral member of a project specific team to ensure
implementation of QAPP requirements and serve as a point of contact for Quality
Assurance Branch (QAB).
Data Management Team
The EPA NAUM Program Data Manager oversees the development of the NAUM Data Portal.
Each RPM and OSC is responsible for data management at a project level, and Data Management
Plans (DMPs) may be developed on a site-by-site or project-by-project basis. The Data Manager
works with project teams and data management staff, including geographic information systems
(GIS) analysts, database developers, and programmers to facilitate generated data being uploaded
to the NAUM Data Portal. The overall NAUM DMP is in development.
Data Manager responsibilities include:
Managing and overseeing NAUM data management systems for receiving, reviewing, and
verifying data deliveries from parties conducting work
Coordinating j oint data needs with program stakeholders (such as Navaj o departments and
agencies)
Coordinating NAUM Program management needs, such as status of projects, with data
systems
Ensuring all proj ects within the NAUM Program receive data management support and are
incorporated into NAUM Program data systems (e.g., the NAUM Data Portal)
Reviewing project-specific DMPs and providing NAUM Program data management
guidance that RPMs and OSCs can provide to data collectors
The Data Manager works with EPA GIS and data systems specialists to ensure NAUM Program
compliance with agency regulations on data management and compatibility with agency guidance
and protocols for data systems.
Office of Radiation and Indoor Air
The EPA Office of Radiation and Indoor Air (ORIA) develops protection criteria, standards, and
policies to protect the public and the environment from the risks and impacts of radiation and
EPA Region 9
Navajo Abandoned Uranium Mines Program
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indoor air pollution. ORIA supports the EPA regions by performing radiochemical analysis of
environmental samples and providing guidance on QA, evaluating and assessing sites
contaminated with radioactive material, providing advice on radiological health and safety
programs, and providing scientific guidance on radiation dose and risk assessment. ORIA, through
its National Analytical Radiation Environmental Laboratory (NAREL), supports the NAUM
Program by providing technical review of radiochemical methods, conducting oversight for
laboratory data validation, and completing quality reviews of radiological data packages. NAREL
supports the Superfund program by providing guidance on the implementation of thq Multi-Agency
Radiological Laboratory Analytical Protocols (MARLAP) Manual (EPA 2004). MARLAP
provides guidance on the planning, implementation, and assessment phases of projects requiring
laboratory analysis of radionuclides. The National Center for Radiological Field Operations assists
the NAUM Program with field oversight to ensure that field work is performed according to
planning criteria. The Radiation Protection Division of ORIA supports the Superfund program by
providing guidance on the implementation of the Multi-Agency Radiation Survey and Site
Investigation Manual (MARSSIM) (EPA 2000b). MARSSIM provides a nationally consistent
consensus approach to conducting radiation surveys and investigations at potentially contaminated
sites and describes how to demonstrate that a site cleanup is in compliance with federal and state
radiation regulations.
Office of Land and Emergency Response
EPA's Environmental Response Team (ERT) in the Office of Land and Emergency Response
(OLEM) provides on-site health physics support, technical advice, and support related to
radiological contamination in all EPA regions. Support can include federal workers and contractor
reach-back support for a wide variety of health physics needs at emergency response and remedial
sites for exposure rate, contamination, and airborne concentration measurements. ERT provides
nuclide-specific airborne concentration limits for on-site worker protection for respiratory
protection and site boundary monitoring and has additional caches of standardized radiological
instrumentation that regions can use for larger site needs. ERT also houses specialized equipment
for remote exposure rate monitoring with the SkyLink and ShortLink systems, swipe and air filter
concentration screening, gas flow proportional gross alpha/beta floor monitors, and gamma
contour mapping that is compatible with ESRI ArcGIS software tools. In addition, EPA's Airborne
Spectral Photometric Environmental Collection Technology (ASPECT) airplane is located near
Dallas, Texas, and is part of EPA's Consequence Management Advisory Division, also under
OLEM. The ASPECT airplane has been used as a tool to collect radiological data for NAUMs in
several areas of the Navajo Nation. This information, collected from approximately 300 to 500 feet
in altitude, is a screening tool for understanding where ground investigations may be warranted.
However, cleanup decisions are based on data collected on the ground.
Partner Agencies
EPA NAUM Program personnel will often coordinate with other stakeholder agencies based on
unique project-specific factors. While all NAUM projects require coordination with the Navajo
Nation government and affected communities throughout the process, many projects may require
coordination with other federal agencies before, during, or following project implementation.
Partner agencies will often review EPA deliverables and data and participate in the determination
of project recommendations. Potential partnering agencies are identified during the initial project
planning process. Table 1-2 shows the list of common partner agencies at EPA NAUM sites. If
EPA Region 9
Navajo Abandoned Uranium Mines Program
Page 9
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private lands are involved, coordination with the States of Arizona, New Mexico, or Utah may
also be required.
EPA Region 9 Quality Management Plan
Navajo Abandoned Uranium Mines Program
Page 10
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Table 1-2 - Partner Agencies
Agenev
Abbreviation
United States Environmental Protection Agency Region 9
EPA Region 9
United States Environmental Protection Agency Region 6
EPA Region 6
Navajo Nation Environmental Protection Agency
NNEPA
Navajo Abandoned Mine Lands Reclamation Program
NAMLRP
United States Army Corps of Engineers
USACE
Bureau of Indian Affairs
BIA
Indian Health Service
IHS
United States Coast Guard
USCG
United States Geological Survey
USGS
Agency for Toxic Substances and Disease Registry
AT SDR
Nuclear Regulatory Commission
NRC
United States Department of Energy
DOE
NAUM Standard Quality Practices
Every NAUM project should include sufficient QA to assess and document the suitability of the
data used for decision-making; the level and type of effort should be commensurate with decision
significance and risks to ensure optimal use of limited resources. The QMP should be reviewed at
least annually as part of NAUM Program's continuous improvement process and will be revised
at least every 5 years.
The NAUM Program has adopted specific approaches to implement its QA program in a
uniform and efficient manner. These standard practices supplement or adapt requirements in
the Region 9 QMP or guidance referenced therein.
This QMP supplements existing EPA guidance in the following areas:
Review and approval of QAPPs
Field oversight
Validation of data
Laboratory competency
Continuous improvement
Deterrence of fraud
Review and Approval of QAPPs
The NAUM Program's QAPP review and approval process is described below. This process
ensures consistency, transparency, and conformance to EPA data quality policies.
Responsibilities for Implementation of the Review and Approval Process
Table 1-3 describes the responsibilities of the NAUM Program Supervisor, Project Managers, and
the RQAM or delegated QA Reviewer for the implementation of the QAPP review and approval
process. Table 1-4 presents the NAUM QAPP approval guide.
EPA Region 9
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Table 1-3 - Responsibilities for Implementation of the Review and Approval Process
NAl'M Program Supervisors
Ensure that the approval process is implemented and complete
Coordinate with the RQAM to obtain any necessary program support
Ensure appropriate training for RPMs and OSCs
Resolve conflicts between technical reviewers and consult with the RQAM when
necessary
Provide guidance to RPMs and OSCs for the level of effort for a QAPP review (see
Section 6 of 1.4.1 )
Primarily for unforeseen circumstances, any significant deviations from the NAUM QMP,
consult with affected parties and the RQAM
NAl'M Project Managers (UPM/OSQ
Initiate appropriate re\ iew s, including determining scope, approach, and the le\ el of effort
for a QAPP review
Coordinate comments and review of revisions
Consult with the RQAM for any unusual QAPP specifications to ensure consistency and
conformance to EPA policies and standards
Inform the RQAM of any significant QA concerns identified that could recur or be a
systematic problem affecting other projects or sites
Sign the QAPP to document agency approval (see Table 1-4)
Ensure that required external signatures are obtained or otherwise document process
deviations
Document other approvals as appropriate
UQAM or Delegated QA Reviewer
Assist RPM/OSC with tasks listed above
Ensure QAPP policies and procedures meet Agency requirements via reviews
Ensure the level of reviews are commensurate with decision risks, primarily defined by
the NAUM RPM requesting a specific QAPP review
Periodically, at least annually, consult with NAUM management about any ongoing
concerns or priorities
Provide training, as necessary or requested, about EPA QA policies and procedures
Sign QAPPs requiring R9QAM approval (See Table 1-4)
Notes:
i
EPA United States Environmental Protection Agency
NAUM Navajo Abandoned Uranium Mine
OSC On-Scene Coordinator
QA Quality Assurance
QAPP Quality Assurance Proj ect Plan
QMP Quality Management Plan
RPM Remedial Project Managers
RQAM Regional Quality Assurance Manager
Table 1-4 - NAUM QAPP Approval Guide
EPA Region 9
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Project Typo
Project Category
QAPP Approval Signature Requirements1
EPA
External Pnrlner
UPM/OSC
UQA.M2
Na\ajo
EPA
Implementing
Entity'
PRP-Lead
All
V
Trustee
All
V
V
EPA-Lead
RSE
V
RI/FS/
Final Status
Survey
y
y
V
Time Critical4
EPA Funded
Interagency
Agreement/Grant
All
y
V
V
Notes:
1 Approvals are required by EPA regulation or policies, or enforcement agreement (in the case of the trustee). In the rare case that
the non-EPA entity may refuse or does not have authority to sign the QAPP, the reason for this deviation must be well
documented.
2 EPA may form teams where other EPA organizations (i.e., ERT) perform site work under the direction of the EPA
NAUM RPM. Factors such as efficiencies, roles, responsibilities, and authorities should be considered by the NAUM
RPM and RQAM to determine if, on a project-specific basis, another EPA organization's QAM can substitute for the
RQAM.
3 The implementing entity could be a PRP, trustee, EPA contractor, another federal agency, grant recipient, etc.
4 Time Critical QAPPs do not have a mandatory approval process; however, a predefined model QAPP is typically used.
EPA United States Environmental Protection Agency
ERT Environmental Response Team
NAUM Navaj o abandoned uranium mine
OSC On-Scene Coordinator
PRP Potentially responsible party
QAM Quality Assurance Manager
QAPP Quality Assurance Proj ect Plan
RI/FS Remedial Investigation/Feasibility Study
RPM Remedial Project Manager
RQAM Regional Quality Assurance Manager
RSE Removal Site Evaluation
1.4.1.1 Documentation of QAPP Approval
Documentation Methods. For any QAPP requiring an approval signature (see Table 1-4), the
NAUM RPM or OSC is responsible for ensuring that all appropriate signatures are obtained for
EPA records. However, the NAUM Program allows the RPM or OSC to accommodate unusual
circumstances that preclude a timely signature. Methods of documenting a QAPP approval are:
Signature block on the QAPP (preferred; see Appendix A for an example signature pages)
Physically attaching or merging electronically into one PDF an approval memorandum to
a QAPP
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NAUM RPM or OSC providing a hand annotation of the QAPP that documents who
approved the document, the date of approval, and the method of approval communication
Date of Approval. Generally, the date of approval is the date the QAPP or approval memo is
signed. In absence of a recorded date, the date of receipt of the EPA RPM or OSC approval
communication, such as an email, is the effective date.
Verbal Approval. There are two circumstances for verbal approvals:
Extenuating circumstances, such as the NAUM RPM or OSC is in a remote location and
there is urgency to approve a QAPP to meet a deadline
QAPP amendments and addenda that are not complex and do not substantively change an
umbrella QAPP and there is risk of not meeting a deadline should a formal approval process
be followed
The NAUM RPM or OSC should document verbal approvals by annotation of the QAPP document
with the name of the approver and the date of approval. The approval documentation should be
submitted/retained in the Superfund Records Center, preferably as an integral part of the archived
QAPP. If the approval is archived as a stand-alone document, the site record index should clearly
identify the associated QAPP.
1.4.1.2 Reviews for QAPP Nomenclature Variations
Environmental programs frequently use document structures, such as a work plan, sampling and
analysis plan, program plan, sampling plan, investigation plan, and characterization plan. When a
document by any name addresses elements of the QAPP, those QAPP elements should be reviewed
as a QAPP, QAPP amendment, or QAPP addendum. The NAUM RPM or OSC is responsible for
this determination.
1.4.1.3 QAPP Amendments and Addenda
Both amendments and addenda to a previously approved QAPP are common for environmental
work and both should be treated as a QAPP for determining the appropriate approval process.
Frequently, changes described by amendments and addenda are not complex and do not
substantively change the umbrella QAPP. In this case, the NAUM RPM or OSC may decide not
to request a formal review by the RQAM; however, the RPM or OSC shall annotate such
documents with corresponding rationale.
1.4.1.4 Level of Review
Minimum Level of Review. The level of detail for a QAPP approval review will vary based on the
NAUM RPM's determination of the project's significance or vulnerabilities. In general, the
minimal level of effort is a professional judgment determination whether a good-faith effort to
address each of the QAPP elements specified in the EPA Requirements for Quality Assurance
Project Plans (EPA 2001a) has been made and whether EPA policy requirements have been met.
Scope of Review. The RPM may request assistance with the technical QAPP review from the
RQAM or from an EPA contractor. QAPP reviewers exercise judgment about whether to
independently verify references, cross-references, calculations, documentation adequacy for
professional judgment and assumptions, completeness of conceptual models, adequacy of the level
of detail in procedures, and appropriateness of applied standards and methodology.
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Tailored QAPP Reviews. QAPP reviewers commonly review a subset of the QAPP planning
elements as requested by the NAUM RPM. Typically, these are aspects related to conformance to
EPA policies, new methods or contractors, or QA-related concerns found in technical reviews.
ROAM and Laboratory Method Reviews. Traditionally, the RQAM is responsible for reviewing
the technical adequacy of laboratory methods specified in a QAPP; however, for radiochemical
methods, the Region 9 QA Branch does not currently have an adequate level of expertise. In the
interim, the NAUM RPM is responsible for obtaining, as necessary,2 a technical review of
QAPP-specified radiochemical methods from EPA's oversight contractor, NAREL, or ERT.
1.4.1.5 Technical Standard for QAPP Reviews
EPA encourages the use of consensus standards when relevant and appropriate. These include
ASTM International (ASTM), Uniform Federal Policy for Quality Assurance Project Plans, and
MARSSIM. Regardless of the approach to QAPP development, the QAPP is evaluated using EPA
Requirements for Quality Assurance Project Plans (EPA 2001a). (See the QAPP Review Checklist
in Appendix B.)
Field Oversight Tools and Considerations
All NAUM field activities should be monitored by planned EPA oversight of the type and level
sufficient to mitigate vulnerabilities. The NAUM Program has no default list of oversight activities
as the vulnerabilities from field activities vary with site-specific circumstances. Hence, EPA
applies a framework with tools, triggers, and goals. In general, every project involving sampling
is under EPA surveillance with random spot checks to typically corroborate the sample locations,
sampling approach, and time of sampling. More complex oversight activities, such as split
samplings, are performed either as a program-wide minimum effort or in response to identified
project-specific risks.
Section 3.2 and Appendix C provide guidance to assist RPMs in planning for oversight.
Validation of Data
The Region 9 QMP3 and references therein are amended to account for radiochemical data.
Responsibilities for initiating or implementing data validation are described in Table 1-5.
Laboratory data used for NAUM projects should undergo data validation based on a graded
approach described in existing EPA guidance. Chemical data should be validated using regional
QA guidance. Radiochemical data should be validated in a manner consistent with the
specifications below. Aspects of implementing radiochemical validation, when not defined in
regional guidance, should be defined in a QAPP. Chemical data validation is based on relevant
national functional guidelines.4 Radiochemical data validation for the NAUM Program is based
on the American National Standards Institute (ANSI) 41.5 Standard.5
2 Most of the NAUM projects are in the investigation phase and use the same laboratory methods for identical DQOs
where other factors, such as the field contractor and laboratory, are the same. In these cases, an additional technical
review is not performed.
3 Section 5.2.4 of the September 2014 Region 9 QMP.
4 EPA guidelines can be found at https://www.epa.gov/clp/superfund-clp-national-functional-guidelines-data-
review.
5 Available for purchase at https://webstore.ansi.org/standards/ansi/ansians412012.
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Region 9 QA uses the terms Tier 1, Tier 2, and Tier 3 to describe the type of verification required
for data validation:
Tier 1 validation under Region 9 QA guidance is ANSI verification.
Tier 2 or Tier 3 validation is a subset of checks covered by ANSI verification and
validation. The EPA Region 9 Radiochemical Data Validation SOP in Appendix D defines
the subset of ANSI checks covered by Tier 3 validation.
Radiochemical data validation for the NAUM Program should meet the following specifications:
1) Validation should be based on the consensus standard Verification and Validation of
Radiological Data for Use in Waste Management and Environmental Remediation
(American Nuclear Society 2012).
2) The data validator should be independent of the laboratory performing the measurements.
This is applicable to both chemical and radiochemical data. For significant site decisions
or when other oversight monitoring suggests a lab oratory-related quality problem,
radiochemical data validation should be performed by a third party relative to the sampler,
laboratory, and responsible party. For most projects, a third party is the EPA Region 9 QA
Branch, NAREL, or another EPA organization. The validator should be described in a
project-specific QAPP.
The intent of this specification is to ensure that the data validation conclusions about data
quality are acceptable to all stakeholders and to deter laboratory fraud found historically
on some CERCLA projects.
The RQAM will request a "Quality Review" from NAREL for radiological laboratories on
a periodic basis as necessary. When such a review is necessary, a minimum of one batch
of data (typically 20 samples or less) for each radiological method should be reviewed. The
intent of this requirement is to mitigate risks of undetected systematic laboratory problems.
The RQAM will maintain a list of reviewed laboratories on the NAUM SharePoint website.
3) A validator performing Tier 3 validation (EPA Region 9 QA system) should meet
qualification requirements in ANSI Standard 41.5. Validators performing Tier 1 validation
need only meet qualification requirements established for validation of inorganic chemical
data by the EPA Contract Laboratory Program. A Tier 3 validation report should document
whether the validator meets this qualification or not.
4) Levels of validation effort for radiochemical data should be defined on a project-specific
basis in a QAPP based on regional QA guidance.
5) The Regional QA Branch should be consulted for any clarification about what and when
to validate data.
6) NAREL, as EPA's center of excellence for radiological laboratory methods, should be
consulted for any significant technical disagreements surfaced in data validation reviews
and used to referee any significant method disagreements between EPA and an outside
organization.
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Table 1-5 - Data Validation Responsibilities
YM'.M UPM
Selects data for validation
Determines the appropriate amount of data to validate
Initiates the validation process with the oversight contractor, NAREL, or RQAM
Ensures that data validation report conclusions are provided to data users
YM'.M RQAM
Monitors the validation processes for consistency via spot checks of systemwide validation
reports
Informs NAUM Supervisors of project consistency concerns
Provides guidance and consultation on EPA QA policies and EPA Region 9 procedures
Provides validation services for non-radiological data
Provides Tier 1 validation for radiological validations
Notes:
EPA United States Environmental Protection Agency
NAREL National Analytical Radiation Environmental Laboratory
NAUM Navajo abandoned uranium mine
QA Quality assurance
RPM Remedial Proj ect Manager
RQAM Regional Quality Assurance Manager
Laboratory Competency
Laboratories used for NAUM projects should be pre-qualified to meet project data quality
objectives. For chemical data laboratories, EPA guidance should be consulted for relevant
pre-qualification requirements. For radiochemical laboratories8, the pre-qualification requirement
can be met by meeting applicable chemical laboratory guidance and the following specifications:
1) Radiochemical laboratories must be accredited by a generally recognized consensus body
to meet applicable and relevant laboratory certification standards. For example, the
laboratory can be accredited to meet the most current relevant United States Department
of Defense (DOD) and United States Department of Energy's (DOE) Consolidated Quality
Systems Manual (QSM) for Environmental Laboratories.9
2) Radiochemical laboratories must have acceptable performance on a relevant
interlaboratory calibration study or a performance test sample in accordance with its
accreditation. For example, this requirement can be met by providing acceptable results of
an annual performance test, preferably on a similar matrix. Alternatively, when available
for the specific proj ect matrix and analytes, a commercial interlaboratory study can be used.
Continuous Quality Improvement
The NAUM Program is committed to continuous improvement with regard to efficient use of
EPA's limited resources through adoption of best practices and lessons learned. NAUM team
meetings, quality system training, data quality assessments, and peer review activities provide
opportunities to identify areas for improvement that can be addressed in subsequent projects. Some
8 Details about evaluating and overseeing a laboratory's performance can be found in Chapter 7 of MARLAP.
9 The DOD and DOE QSM standard can be found at www.denix.osd.mil/edqw/documents/.
The accreditation status of a laboratory can be verified at www.denix.osd.mil/edqw/accreditation/
accreditedlabs/.
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of these examples are already in place to identify process improvement opportunities and propose
solutions for problems. Other measures may be developed more fully in the future.
1. Encouraging Staff to Identify and Implement Quality Improvements
NAUM Program Managers ensure periodic technical meetings occur to provide a forum for staff
to share best management practices. These interactions are critical for RPMs to share lessons
learned from the identification of issues adverse to quality. These discussions encourage staff to
identify process improvements and propose corrective actions.
2. Program-Level Improvement
The Region 9 QA Branch routinely performs quality system assessments of the various regional
programs. These internal quality system assessments are conducted with the objectives of verifying
that the program is complying with the requirements of Region 9's quality system as documented
in the regional QMP; identifying areas for improvement; and serving as an educational opportunity
to enhance understanding of the quality system and how it can be applied in specific project areas.
Where necessary, aspects are modified to address evolving programs and changing needs, and the
modifications will be documented in a revision to the QMP.
3. Project-Level Improvement
NAUM staff members are all accountable for the continuous improvement of the quality of their
products. The process of continuous quality improvement leads to a better and more responsive
program. Supervisors, RPMs, and other technical staff are encouraged to identify opportunities for
improving the quality system through discussion with their management or by contacting regional
QA Branch staff.
4. Tracking System. Record Keeping, or Annual Presentation
It is important that lessons learned from past activities are communicated among NAUM team
members for the improvement of project planning, field and laboratory procedures, data
management, record keeping, safety, and cost effectiveness. The NAUM Program will document
lessons learned from previous data gathering activities and incorporate them into future efforts.
The implementation of a tracking system will be developed.
Deterrence of Fraud
The NAUM Branch Manager ensures that an active ethics program, which provides a clear
understanding of staff responsibilities and how staff can report any concerns, remains an integral
part of the NAUM Program. An annual 1- or 2-hour presentation from an invited speaker, such as
the EPA Office of Inspector General (OIG), will be provided with a focus on describing types of
fraud and how they can be detected. A relevant presentation or training on a region-wide basis may
substitute for NAUM-specific training as determined by the NAUM Branch Manager.
EPA RPMs will periodically verify that work performed under contracts is managed under a
program with clear ethics statements, responsibilities, and information about who to contact should
staff have concerns. Generally, EPA RPMs can meet this specification by observing appropriate
information being provided to field staff as an internal contractor program (e.g., at a tailgate
meeting) or by verifying informally that field staff are aware of the EPA OIG reporting hotline
program.
EPA RPMs will verify or designate responsibility to verify that appropriate best practices for
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laboratory and data review described in Best Practices for the Detection and Deterrence of
Laboratory Fraud (California Military Environmental Coordination Committee 1997) are
incorporated into project implementation plans. This verification is typically part of the review
process to approve a QAPP.
For field activities (sampling in particular), NAUM RPMs will follow NAUM Program field
oversight practices (see Section 3.2), which recommend a minimal surveillance effort
supplemented with audits based on a graded approach. By following these practices, EPA RPMs
will ensure that applicable oversight required in EPA's Chief Information Officer (CIO) directive
2105-P-02.0 (EPA 2014) or referenced guidance is applied during project implementation based
on a graded approach.
Quality Objectives and Criteria for Measurement Data
This section introduces several important terms used by EPA QA policy and guidance that govern
how NAUM projects generate data of known quality and sufficient quantity for decision-making.
These terms include DQOs, DQIs, and MQOs. Correct application of these concepts will ensure
that data quality is sufficient to support all NAUM project activities including adequately and
accurately determining the nature and extent of contamination; performing human health and
ecological risk assessments; evaluating and selecting remediation alternatives; monitoring and
assessing remediation activities; and, ultimately, demonstrating that cleanup goals have been
achieved.
The NAUM QMP describes data quality specifications at two levels:
1) At the level of the decision or study question (i.e., DQOs)
2) At the level of the measurements used to support the decision (i.e., DQIs and MQOs)
EPA's systematic planning process (the DQO process) is used to plan and design the study and
investigation activities. The DQO process is utilized to frame the important study questions and
decisions that will need to be carried out for each project in the context of site-specific conditions
and limitations. The outputs of the seven-step DQO process are then used to specify the level of
data quality necessary for the measurements used to support the decision or study question.
QA planning is a proactive process that is preventative in nature; it recognizes vulnerabilities in
the data generation activities and puts a process in place to address and control those
vulnerabilities. The QAPP documents, as part of the QA planning process, provide the approaches,
techniques, methods, and processes that ensure project DQOs will be met. QA planning must be
completed before QC can be implemented.
QC is a part of the overall QA system that focuses on detecting issues with the data and is reactive
in nature. QC activities monitor and verify that the approaches, techniques, methods, and processes
used to manage and create data have been followed correctly and that the project deliverables meet
the defined quality standards. Field surveillance and data validation are two examples of QC
implementation.
Data quality refers to the level of acceptability associated with a particular data set or data point
for its intended uses. Performance and acceptance criteria for measurement data are often
expressed in terms of DQIs. The principal indicators of data quality are precision, bias, accuracy,
representativeness, comparability, completeness, and sensitivity. Acceptance thresholds or QC
goals for project data are expressed in terms of MQOs and serve a critical purpose during the data
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review and validation process. Additional information regarding project DQOs, DQIs, and MQOs
can be found in Section 2.
DATA GENERATION AND ACQUISITION
This section addresses the following data acquisition activities: sampling design, sampling
methodology, sampling documentation, analytical testing, QC, and data management.
Sampling Process Design
The sampling design is a fundamental part of data collection for scientifically based
decision-making. A well-developed sampling design plays a critical role in ensuring that data are
representative and sufficient to draw the conclusions needed.
Representativeness may be considered as the measure or the degree to which data captures the
"true" site conditions. EPA utilizes the systematic planning process, otherwise known as the
seven-step DQO process, to design a site-specific sampling approach that will result in the
collection of a representative data set.
Data Quality Objectives
DQOs are qualitative and quantitative statements that specify the field and laboratory data quality
necessary to support specific decisions or regulatory actions. DQOs describe which data are
needed, why the data are needed, and how the data will be used to meet the needs of the sampling
program. DQOs also establish numeric limits for the data to allow the data user (or reviewers) to
determine whether the data collected are of sufficient quality for their intended use. The seven-step
DQO process, as set forth in EPA's Guidance on Systematic Planning Using the Data Quality
Objectives Process (EPA 2006), should be followed to establish project-specific DQOs for data
collection activities. The seven steps of the DQO process are:
1) State the problem
2) Identify the decision
3) Identify inputs for the decision
4) Define the boundaries of the study
5) Develop a decision rule
6) Specify limits on decision errors
7) Optimize the design
The NAUM Program has established a workgroup to explore best management practices regarding
systematic planning and DQOs for site investigations.
Data Quality Indicators
The quality of data is expressed by DQIs. The principal DQIs are precision, accuracy,
representativeness, comparability, completeness, and sensitivity (PARCCS) and are used as a ruler
for the question of "How good is the project data?"
QC procedures are needed to define the tolerable errors in quantitative measurements that estimate
the true value or concentration of a physical or chemical property. Uncertainty in analytical data
comes from variability in sample collection, sample handling, and the conditions associated with
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the specific samples, as well as analytical variability. Appropriate MQOs for analytical data are
established as quantitative measures of performance against selected DQIs as described below.
Precision
Precision is a measure of the reproducibility of measurements. Typically, analysis of field
duplicate samples provides an estimate of the precision of environmental data.
Analytical precision is estimated by laboratory duplicate analyses typically on laboratory control
samples, spiked samples, or field samples. For chemical analyses, precision is evaluated using the
relative percent difference (RPD). For radiochemical data, precision is evaluated using the
Duplicate Error Ratio (DER). Accuracy
Accuracy is the closeness of measurements to an accepted reference value. Generally, accuracy is
reported as a percent recovery of analytes in samples of known concentrations of analytes (e.g.,
QC samples).
Representativeness
Representativeness is the degree to which a sample accurately characterizes environmental
conditions at the time of collection. Representativeness is dependent on the adequacy of the
sampling design defined in the QAPP.
Comparability
Comparability expresses the confidence with which one data set can be compared to another and
describes the ability and appropriateness of making collective decisions with two or more data
sets. Many variables may affect the descriptive value of the data and include:
Variables of interest in each data set
Use of common units
Similarity of methods and QA/QC
Time frames
Season
Weather
Equipment
Completeness
Completeness is a measure of the amount of usable data obtained from a measurement system
expressed as a percentage of the number of measurements that should have been collected
according to the study design (i.e., the measurements that were planned to be collected).
Sensitivity
Sensitivity refers to the capability of a method or instrument to detect a given analyte at a given
concentration and reliably quantitate the analyte.
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Measurement Quality Objectives
MQOs are the acceptance windows, thresholds, or goals for project data and serve a critical
purpose during the data review and validation process.
Laboratory analytical method parameters (precision, accuracy, and sensitivity) should be
compared against project or program DQIs established during the DQO planning process with
defined acceptable levels of uncertainty throughout the analytical process. Typical NAUM
measurement performance criteria are included in Tables 2-1 through 2-4.
Radiochemical Measurement Quality Objectives
The MQOs that determine acceptable analytical laboratory decision errors are usually obtained
from other similar sampling events based on calculation in the DQO process or based on
programmatic defaults.
Combined Standard Uncertainty (CSU)
The uncertainty of radiochemical measurements is typically expressed as a standard uncertainty
(or one-sigma uncertainty), also referred to as "counting uncertainty," and is expressed as
one standard deviation (lo or "1 sigma" CSU).
The CSU value may be multiplied by a specified factor called a coverage factor (e.g., 2 or 3) to
obtain an expanded combined uncertainty (a 2o or 3o uncertainty), which describes an interval
about the result that can be expected to contain the true value with a specified probability.
All laboratory radiochemical measurements should be reported with the associated CSU and the
laboratory's definition of the CSU. Coverage factors are not standardized between laboratories and
must be documented in data reports.
Minimum Detectable Concentration (MDC)
The MDC is used to evaluate laboratory method performance. Results above the MDC are deemed
to have been reliably detected. Generally, the MDC is used to select laboratory methods to ensure
adequate sensitivity for project objectives. The MDC with another statistical measure (critical
value) are sometimes used in data validation.
All sample results for the NAUM Program should be reported with corresponding instrument- and
method-specific MDC.
For laboratory instruments, the MDC is defined in the MARLAP Manual in Sections 20.4.2 and
20A.3 (EPA 2004); however, the exact procedure used by any laboratory should be defined in its
laboratory QA manual or method SOP.
For field scanning instruments, the MDC is described in Sections 6.7.1 and 6.7.2 of MARSSIM
(EPA 2000b) and NUREG-1507 (United States Nuclear Regulatory Commission 1998). MDCs
should be calculated following instrument calibration and verified during function checks because
instrument background is a key component of the MDC. The MDC, and specific inputs and
formula used to calculate the MDC, should be documented with the reported results.
Minimum Quantifiable Concentration (MQC)
Results must meet an acceptable critical value and exceed the MDC to be considered quantified.
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Unlike chemical measurements, the accuracy of each radiochemical result is reported. At the level
of the MQC, reported results will have a quantitative uncertainty that is small, is relative to the
reported value, and will allow for control of decision errors even though the sampling uncertainty
(which is generally assumed to be approximately three times the analytical uncertainty) is not
quantified and incorporated into the reported results. In practice, the MQC is not used to make
specific data use decisions as the CSU allows for a more precise and specific evaluation. The MQC
concept is retained in the QMP to integrate chemical and radiochemical data interpretation
approaches.
Precision
Precision is an important measure of the repeatability of a measurement as all real-world
measurements can be affected by random fluctuations. Various quality control measure the
precision of measurements.
Overall Precision (Field + Laboratory). Field duplicates as a measure of combined field and
laboratory precision are evaluated using a Z-score, also called a normalized difference, as defined
below. The frequency of a field duplicate sample is defined in a project-specific QAPP and is
typically about 1 per 20 site samples.
Laboratory Precision. Laboratory duplicates are typically used at a rate of 1 in 20 site samples to
evaluate laboratory precision. Matrix spikes (MSs) and matrix spike duplicates (MSDs) are also
sometimes used. The results of the analysis of duplicates and each MS/MSD pair are evaluated
using a Z-score. An acceptable Z-score should be within limits defined by the laboratory's QA
system or the method SOP. If not specified, precision will be evaluated using a factor of 2 or 3
depending on the project DQO.
Definition of Z-Score
A Z10-score for two results is calculated using the following general equation:
U-xJ
4csu2xl +csu2X2
Where:
XI = The value of the first measured result (sample)
X2 = The value of the second measured result (duplicate)
CSU = The reported CSU (at lo) associated with XI and X2
The Z-score for a measured parameter is used to evaluate the significance of the difference between
the two results.
Chemical Measurement Quality Objectives
The chemical MQOs that determine acceptable analytical laboratory decision errors are usually
obtained from other similar sampling events based on calculation in the DQO process or based on
10 Commonly referred to as Decision Error Ratio (DER)
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programmatic defaults.
Method Detection Limit (MDL)
For chemical analyses, the MDL, as defined in 40 Code of Federal Regulations Part 136, is used
to evaluate measurement performance. The MDL is the minimum concentration of a substance
that can be measured and reported with 99 percent confidence that the analyte concentration is
greater than zero.
Reporting Limit (RL)
For chemical analyses, the RL is the lowest concentration that can be reliably achieved within
limits of precision and accuracy during routine operating conditions. The RL is generally 5 to
10 times the MDL, and the implied accuracy of results greater than the RL is defined by the method
SOP.
Precision
Overall Precision (Field + Laboratory). Field duplicates as a measure of combined field and
laboratory precision are evaluated using a RPD calculation as defined below. The frequency of the
field duplicate measurement is defined in a project-specific QAPP and is typically about 1 in
20 site samples.
Laboratory Precision. Analytical precision is evaluated by analyzing laboratory duplicates or
MS/MSD pairs. The results of the analysis of duplicates and each MS/MSD pair will be used to
calculate a RPD for evaluating precision. Laboratory measurement duplicates will be performed
once for every 20 samples. An acceptable RPD is defined by the laboratory's QA system or method
SOP.
Relative Percent Difference Definition
The RPD is calculated as:
Where:
Sample + Duolicate ¦,
I ' 2 /
Sample = The first sample value (original)
Duplicate = The second sample value (duplicate)
Field Sample Collection Methods
Field measurements and sample collection procedures will follow the QAPP and are developed
based on agency and industry guidance and standards, such as EPA methods, ASTM standards,
industry SOPs, and instrument manufacturers' recommended procedures. Procedures will identify
the methods employed to obtain representative field measurements and samples of specified
media, as well as the equipment, instruments, and sampling tools that are needed and, where
appropriate, performance criteria (e.g., special handling, operational checks, and field calibrations)
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to ensure the quality of the field data.
Laboratory Analytical Methods
The analytical techniques and methods to be used will be documented in the site-specific QAPP.
The laboratory shall have SOPs that detail how the required method or technique is implemented.
Method performance shall meet the requirements specified in the site-specific QAPP. Typical
analytical techniques used for NAUM projects are included in Figure 2-1.
Quality Control Requirements
Field Sampling Quality Control
A variety of instruments, equipment, sampling tools, and supplies will be used to collect samples
and to monitor site conditions. Proper inspection, calibration, maintenance, and use of the
instruments and equipment are required to ensure field data quality. The QC objective of data
collection activities is to obtain reproducible and comparable measurements to a degree of
accuracy consistent with the intended use of the data.
Field QC samples are used to quantitatively and qualitatively evaluate the analytical performance
of the laboratory and to assess external and internal effects on the accuracy and comparability of
the reported results. Field QC samples will be uniquely identified in a manner consistent with the
project sample-numbering scheme. Site-specific QAPPs identify the appropriate type of field QC
samples, such as temperature blanks, equipment blanks, and field duplicates.
Temperature Blanks
Where ice is used, each sample cooler shall contain a temperature blank. The temperature blank
should be supplied by the receiving laboratory and can be either a 40- milliliter (mL) vial or a
100-mL plastic bottle filled with reagent grade water. The purpose of the temperature blank is to
document the temperature of the representative solution contained within the same transport cooler
as the collected field sample.
Equipment Blanks
Where non-dedicated equipment is used to collect samples, equipment rinsate blanks should be
collected at a rate of one per day to evaluate field decontamination procedures.
Field Duplicate Samples
Duplicate soil samples should be collected at locations that are chosen randomly in the field and
should be designated for collection at a specified frequency in the site-specific QAPP (typically, a
rate of at least 1 for every 20 field samples).
Laboratory Quality Control
Laboratory QC is designed to detect, reduce, and correct deficiencies in a laboratory's internal
analytical processes to improve the quality of the results reported by the laboratory. The QC system
includes measurement performance criteria for DQIs and MQOs as described in Sections 2.1.2 and
2.1.3 and in Tables 2-1 through 2-4.
Laboratory QC samples generally include preparation and reagent blanks, laboratory control
EPA Region 9
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samples, and, if required by the project, MS/MSD pairs.
Instrument and Equipment Testing, Inspection, Maintenance
A variety of instruments, equipment, sampling tools, and supplies will be used to collect samples
and to monitor site conditions. Proper inspection, calibration, maintenance, and use of the
instruments and equipment are required to ensure field data quality.
Field equipment, instruments, tools, gauges, and other items used in performing work tasks that
require preventive maintenance will be serviced in accordance with manufacturers'
recommendations and instructions. When applicable, technical procedures will identify the
manufacturers' instructions and recommended frequency for servicing the equipment. Preventive
maintenance for calibrated measuring and test equipment will be performed either by field or
laboratory personnel who are knowledgeable of the equipment or by a manufacturer's authorized
service center as part of routine calibration tasks. Records of equipment calibration, repair, or
replacement of controlled instruments will be filed and maintained in accordance with the
applicable records management requirements described in the site-specific QAPP.
Field equipment, instruments, and associated supplies used to obtain field measurements and
collect samples are described in the site-specific QAPP. Any item, data, or process found to be in
noncompliance with specified requirements will be documented as defined in Section 3.1.2.
The project roles and responsibilities provided in the site-specific QAPP should define the
technical or field lead who is responsible for ensuring the overall maintenance, operation,
calibration, and repairs made to field equipment, instruments, and tools are in conformance with
SOPs and manufacturers' recommendations and that the field records adequately document
maintenance, repairs, and calibrations performed in the field.
Instrument and Equipment Calibrations and Frequency
Equipment and instruments used to obtain data will be maintained and calibrated with sufficient
frequency and in such a manner that accuracy and reproducibility of results are consistent with the
manufacturers' specifications. Calibration of equipment and instruments will be performed at
approved intervals, as specified by SOPs or manufacturers' recommendations, or more frequently
as conditions dictate. Calibration standards used as reference standards will be traceable to the
National Institute of Standards and Technology (NIST) or other recognized standards when
available. In some instances, calibration periods or operational response checks will be based on
usage rather than periods of time. Equipment will be calibrated or response checked as a part of
its operational use. Calibrations and operational checks will be performed and documented in
accordance with procedure requirements. Calibration procedures for field equipment are described
in the Work Plan and manufacturers' equipment manuals.
The responsibility for the calibration of laboratory equipment rests with the selected laboratory.
Each type of instrumentation and each EPA-approved method have specific requirements for the
calibration procedures, depending on the analytes of interest and the sample medium. Calibration
procedures and calibration frequency for the equipment used to perform the analyses will be in
accordance with requirements established by the EPA methods.
The laboratory is ultimately responsible for ensuring that the laboratory instrumentation is
maintained in accordance with specifications. Individual laboratory SOPs will be followed for
corrective actions and preventative maintenance frequencies.
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Gamma Scanning Field Measurements
This subsection has been written specifically for field gamma scanning; however, other field
techniques (e.g., X-ray fluorescence) may be added to the NAUM Program as they become more
frequently utilized.
The NAUM Program relies heavily on field gamma scanning measurements to interpret,
characterize, and delineate the extent of contamination. Various field equipment QA procedures
can be utilized to ensure that field gamma scanning is consistent with project DQOs.
To utilize the gamma scanning data for decision-making, EPA must ensure that adequate QC steps
are performed and documented. Therefore, general QC checks, such as those included in
Appendix E, should be considered when reviewing any gamma scanning SOPs identified in the
project QAPP. The checklist for gamma scanning will be further developed in the future.
Non-Direct Measurements
Sources and types of secondary data useful for this project include the following:
Historical records
Previous investigations
Regulatory agency files
Topographic maps
Historical aerial photographs
Visual site reconnaissance
Interviews
The quality of these secondary data sources must be evaluated to ensure that they are of the type
and quality necessary to support their intended uses. When evaluating the reliability of secondary
data and determining limitations on their uses, the source of the data, time period during which
they were collected, data collection methods, potential sources of uncertainty, type of supporting
documentation available, and comparability of data collection methods to the currently proposed
methods should be evaluated. With respect to secondary analytical data that will be utilized to
support critical decisions, such as a comparison of contaminant levels with applicable standards, a
detailed review of the data will be necessary to determine the usability of the data.
For additional information and guidance, see Chapter 3 of EPA's Guidance for Quality Assurance
Project Plans (EPA 2002a).
Gamma Data Validation Considerations
An example oversight checklist for gamma scanning activities is under development (see
Appendix E) and will be available in future revisions of this QMP. Examples of parameters which
may be included in this checklist are listed below.
Performance checks validate that equipment is working correctly and verify the accuracy of
gamma scanning data, including:
Meter and source checks
o Document the calibrations and daily source checks before and after daily use
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o Use NIST-traceable sources
o Check meter battery life, settings, and calibration due dates
o Check daily source count results against a control chart
o Complete equipment logs
Data collection evaluation
o Ensure that scanning rates (the speed that the radiological technician walked) are not
too fast, and that the instrument was paused when the surveyor stopped walking for
any reason
o Ensure that coverage was adequate by looking at the number of mapped points
measured within a specific time period and area, etc.
o Control the stand-off distance of detector(s) from the surface using a mechanical
device
Global positioning system (GPS) accuracy
o Check GPS data against a benchmark for accuracy (Terrasync tracks data on
horizontal accuracy that could be evaluated)
Coverage evaluation
o Continually review maps and check to make sure that all of a desired area was
monitored and that no parts of the area were missed as indicated by no measurement
points
Data delivery
o Define specific formats and data delivery streams to access and review raw and
modified data, including:
¦ Spatial gamma scanning sensor and GPS data
Mesa2: GSF
Trimble: SSF
ArcGIS: SHP, DBF
Metadata: XML
¦ Waypoints and areas of interest
Pressurized Ion Chamber (PIC) data: CSV
SCRIBE electronic data deliverable: CSV
Sample locations: CSV, GSF, SSF
Static measurement locations: CSV, GSF, SSF
Areas of interest: CSV, GSF, SSF, XML
¦ Operational viewers and portals
Document archive: NAUM Portal
Operational viewer: Geoviewer
VIPER: Viper.net
EPA Region 9
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Figure 2-1 - Typical Analytical Techniques
Sample Media Typical Analyte Analytical Method Field Method
Typical Sampling Activities at
Abandoned Uranium Mines
Soil Sampling
Notes:
DOE United States Department of Energy
EML Emission Measurement Laboratory
EPA United States Environmental Protection Agency
HASL Health and Safety Laboratory
SW Solid waste
Radium-226
Lead-210
Thorium-232
Arsenic
Molybdenum
Selenium
Uranium
Lead-210
Uranium
Arsenic
Molybdenum
Selenium
Mercury
Gross Alpha
Gross Beta
EPA 901.1m
EML HASL 300
SW 6010B, SW 6020
Mercury
SW 7471
Radium-226/228
EPA 903.0/904,0
Gross-Alpha
EPA 900.0
EML HASL 300
EPA 200.7, EPA 200.8
SW 7470
Radium-226
EPA 903.1
Thorium-230/232
DOE EML HASL 300
Uranium-23 4/238
Gamma Activity
Scanning
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Table 2-1 - Typical NAUM Laboratory Methods
Analvte
Matrix
Analytical
Method
Parameters
Method
Modifications
Sample Prep
Other?
Preservative
Molding
lime
Volume
Container
Screening
Level12
Reporting
l.imi(!
Method
Detection
Limit-'
Metals by ICP-MS:
Arsenic
Soil/
Sediment
SW 601 OB,
SW 6020
uranium, arsenic,
molybdenum,
selenium, and
vanadium
4°C
180 days
4 oz
Glass/
Poly
0.29
mg/kg
0.25
mg/kg
0.02
mg/kg
EML
Lead - 210
Soil/
Sediment
HASL-300
Method Ga-
01-R
Gamma radioassay,
21 day in-growth
None
N/A
4 oz
Poly /
Ziploc
N/A
1 pCi/g
0.1 pCi/g
Mercury
Soil/
Sediment
SW 7471
Mercury by cold
vapor atomic
adsorption
spectrometry
4°C
28 days
4 oz
Glass/
Poly
11 mg/kg
1 mg/kg
0.0036
mg/kg
Metals by ICP-MS:
Molybdenum
Soil/
Sediment
SW 6010B,
SW 6020
uranium, arsenic,
molybdenum,
selenium, and
vanadium
4°C
180 days
4 oz
Glass/
Poly
390 mg/kg
1 mg/kg
0.47
mg/kg
Metals by ICP-MS:
Selenium
Soil/
Sediment
SW 6010B,
SW 6020
uranium, arsenic,
molybdenum,
selenium, and
vanadium
4°C
180 days
4 oz
Glass/
Poly
0.26
mg/kg
0.158
mg/kg
0.158
mg/kg
Metals by ICP-MS:
Uranium
Soil/
Sediment
SW 6010B,
SW 6020
uranium, arsenic,
molybdenum,
selenium, and
vanadium
4°C
180 days
4 oz
Glass/
Poly
14 mg/kg
0.1 mg/kg
0.001
mg/kg
No sample treatment.
Radium-226
Soil/
Sediment
EPA
901.1m
Radium-226 (with
21-day in-growth),
including other
gamma emitters
(e.g., uranium-238
progeny,
thorium-232
progeny, and
potassium-40)
Radiological
laboratory-specific
procedures may
modify the method
with specific
instrument models,
count times,
geometry for sample
containers,
container sealing
procedures, or other
details without
invalidating the
data.
Typical sample
preparations include
grinding, mixing,
homogenizing,
aliquoting samples into
standardized containers,
and sealing containers to
ensure that radon gas
does not escape prior to
counting the sample.
Alternate grow-in
periods shorter than
21 days are possible but
likely result in increased
counting error.
Sample containers
may be jars,
bottles, or poly
bags. No sample
treatment or
preservation
required.
None
N/A
2 kg
Poly /
Ziploc
N/A
1 pCi/g
0.1 pCi/g
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Table 0-1 - Typical NAUM Laboratory Methods (Continued)
Analvte
Matrix
Analytical
Method
Parameters
Method
Modifications
Sample Prep
Other?
Preservative
Molding
lime
Volume
Container
Screening
Level12
Reporting
Limit-'
Method
Detection
Limit-'
Thorium-232
Soil/
Sediment
EML
HASL300
Thorium-232 by
alpha spectroscopy
- EML HASL
Method 300
TH-01-RC
Modified, using
alpha spectroscopy
None
N/A
4 oz
Poly /
Ziploc
N/A
1 pCi/g
0.1 pCi/g
Arsenic
Water
EPA 200.7,
EPA 200.8
Metals by ICP-MS:
uranium, arsenic,
molybdenum,
selenium, and
vanadium
HN03, 4°C
180 days
4 oz
Poly
10|ig/L
10|ig/L
2 |ig/L
Lead-210
Water
EML
HASL-300
Method
Ga-01-R
Gamma radioassay,
21 day in-growth
HN03, 4°C
N/A
1,000
mL
Poly
15 |ig/L
1 |ig/L
1 |ig/L
Mercury
Water
SW 7470
Mercury by cold
vapor atomic
adsorption
spectrometry
HN03, 4°C
28 days
250 mL
Poly
2 |ig/L
0.2 |ig/L
0.2 |ig/L
Molybdenum
Water
EPA 200.7,
EPA 200.8
Metals by ICP-MS:
uranium, arsenic,
molybdenum,
selenium, and
vanadium
HN03, 4°C
180 days
4 oz
Poly
1000 |ig/L
1 |ig/L
1 |ig/L
Selenium
Water
EPA 200.7,
EPA 200.8
Metals by ICP-MS:
uranium, arsenic,
molybdenum,
selenium, and
vanadium
HN03, 4°C
180 days
4 oz
Poly
5 |ig/L
1 |ig/L
1 |ig/L
Uranium
Water
EPA 200.7,
EPA 200.8
Metals by ICP-MS:
uranium, arsenic,
molybdenum,
selenium, and
vanadium
HN03, 4°C
180 days
4 oz
Poly
30 |ig/L
1 |ig/L
0.1 ng/L
Uranium
Isotopes
Water
DOE
HASL300
U-02-RC
Uranium-234,
Uranium-23 5,
Uranium-23 8
HN03, 4°C
180 days
1 gallon
Poly
30 |ig/L
1 |ig/L
0.1 ng/L
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Table 0-1 - Typical NAUM Laboratory Methods (Continued)
Analvte
Matrix
Analytical
Method
Parameters
Method
Modifications
Sample Prep
Other?
Preservative
Molding
lime
Volume
Container
Screening
Level12
Reporting
Limit-'
Method
Detection
Limit-'
Combined
Radium-226
+228
Water
EPA
903.0/904.0
Radium-226
(water) by alpha
spectroscopy/
scintillation
counting
Lab-specific
procedures may
modify the sample
volume, treatment,
and count times
without invalidating
the data.
At collection, nitric acid
is added to pH 2 (or
untreated samples should
be received at the lab),
acidified in the original
sample container, and
held for at least 16 hours
before processing.
Typical sample
preparation includes
barium co-precipitation
to isolate radium via wet
chemistry.
Sample
containers: plastic
bottle preferred
over glass to
prevent breakage.
Alpha scintillation
counting or gas
proportional
counting if
interference from
radium-223 or
radium-224 is
expected.
Ingrowth of decay
products may
interfere with
counting.
hno3
180 days
1 L
Poly
5 pCi/L
1 pCi/L
1 pCi/L
Gross-Alpha
Radiation
Water
EPA 900.0
Gross alpha by
scintillation
counting.
Lab-specific
procedures may
modify the sample
evaporation/solid
concentrating and
plating process, the
instrument model,
the count time, and
other details of the
procedure without
invalidating the
data.
At collection, nitric acid
is added to pH 2 (or
untreated samples should
be received at the lab),
acidified in the original
sample container, and
held for at least 16 hours
before processing.
Typical sample
preparations include
aliquoting based on total
dissolved solid levels in
the sample and
evaporation of water
from the aliquot to plate
the solids on a planchet,
Sample
containers: plastic
bottle preferred
over glass to
prevent breakage.
Sample density on
the planchet
should be about
5 mg/cm2. Gas
flow proportional
counters are
acceptable, but
reabsorbed
moisture and
static interference
may reduce
analytical
sensitivity through
increased
self-ab sorption
and erratic
counting,
respectively.
Scintillation
counters are
preferred.
hno3
180 days
500 mL
Poly
15 pCi/L
5 pCi/L
1 pCi/L
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Table 0-1 - Typical NAUM Laboratory Methods (Continued)
Notes:
1 Soil/Sediment values are EPA Regional Screening Levels for Protection of Groundwater.
2 Water values are EPA Maximum Contaminant Levels.
3 Standard values are shown, but reported values on laboratory data reports may vary based on sample conditions and results of sample preparation.
Not applicable
(ig/L Microgram per liter
DOE United States Department of Energy
EML Emission Measurement Laboratory
EPA United States Environmental Protection Agency
HASL Health and Safety Laboratory
HNO3 Nitric acid
ICP-MS Inductively coupled plasma-mass spectrometry
L Liter
mg/cm2 Milligram per square centimeter
mg/kg Milligram per kilogram
mL Milliliter
N/A Not applicable
NAUM Navajo abandoned uranium mine
oz Ounce
pCi/g Picocurie per gram
pCi/L Picocurie per liter
SW Solid waste
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Table 2-2 - Typical Data Quality Indicators for Soil and Sediment Samples
Analyle'
Screening
1 .evel2
Reporting
Limit-'
Method
Detection
Limit'
Accuracy
(Percent
Recovery for
Laboratory
Conlrol Sample)
Precision
(Relative Percent Difference
for Matrix Spike / Matrix
Spike Duplicates and Lield
Duplicates)
/-Score4
Percent
Complete
Arsenic
0.29
mg/kg
0.25 mg/kg
0.02
mg/kg
75-100%
< 35%;
< 50% for field duplicates
-
> 90%
Lead-210
N/A
1 pCi/g
0.1 pCi/g
75-100%
< 35%;
< 50%) for field duplicates
<2.0
> 90%
Mercury
11 mg/kg
1 mg/kg
0.0036
mg/kg
75-100%
< 35%;
< 50%) for field duplicates
-
> 90%
Molybdenum
390 mg/kg
1 mg/kg
0.47
mg/kg
75-100%
< 35%;
< 50%) for field duplicates
-
> 90%
Selenium
0.26
mg/kg
0.158
mg/kg
0.158
mg/kg
75-100%
< 35%;
< 50%) for field duplicates
-
> 90%
Thorium-232
N/A
1 pCi/g
0.1 pCi/g
75-100%
< 35%;
< 50%) for field duplicates
<2.0
> 90%
Uranium
14 mg/kg
0.1 mg/kg
0.001
mg/kg
75-100%
< 35%;
< 50%) for field duplicates
-
> 90%
Radium-226
N/A
1 pCi/g
0.1 pCi/g
75-100%
< 35%;
< 50%) for field duplicates
<2.0
> 90%
Notes:
1 Typical analyte of concern at Navajo abandoned uranium mines.
2 Values are soil/sediment EPA Regional Screening Levels for Protection of Groundwater
3 Standard/typical values are shown, but reported values on laboratory data reports may vary based on sample conditions and results of sample preparation.
X X
4 Z = -Jcsu\ csu2 Where XI = first measured result (sample); X2 = second measured result (duplicate); and CSU = reported CSU (at la) associated with XI and X2.
CSU Combined standard uncertainty
EPA United States Environmental Protection Agency
mg/kg Milligram per kilogram
N/A Not applicable
pCi/g Picocurie per gram
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Table 2-3 - Typical Data Quality Indicators for Water Samples
Analyte1
Screening
Level2
Report in«
Limit'
Method
Detection
Limit-'
Accuracy
(Percent
Recovery for
Laboratory
Control
Sample)
Precision
(Relative Percent
Difference for Matrix
Spike / Matrix Spike
Duplicates and I' ield
Duplicates)
Z-Score4
Percent
Complete
Arsenic
10|ig/L
10|ig/L
2 |ig/L
75-100%
< 35%
-
> 90%
Lead-210
15 |ig/L
1 |ig/L
1 |ig/L
75-100%
< 35%
<2.0
> 90%
Mercury
2 |ig/L
0.2 |ig/L
0.2 |ig/L
75-100%
< 35%
-
> 90%
Molybdenum
1000 |ig/L
1 |ig/L
1 |ig/L
75-100%
< 35%
-
> 90%
Selenium
5 |ig/L
1 |ig/L
1 |ig/L
75-100%
< 35%
-
> 90%
Uranium
30 |ig/L
1 |ig/L
0.1 ng/L
75-100%
< 35%
-
> 90%
Uranium Isotopes
30 |ig/L
1 |ig/L
0.1 ng/L
75-100%
< 35%
-
> 90%
Combined
Radium-226+228
5 pCi/L
1 pCi/L
1 pCi/L
75-100%
< 35%
<2.0
> 90%
Gross-Alpha
Radiation
15 pCi/L
5 pCi/L
1 pCi/L
75-100%
< 35%
<2.0
> 90%
Notes:
1 Typical analyte of concern at Navajo abandoned uranium mines.
2 Values are EPA maximum contaminant levels.
3 Standard/typical values are shown, but reported values on laboratory data reports may vary based on sample conditions and results of sample preparation.
4 z = xi~xz Where XI = first measured result (sample); X2 = second measured result (duplicate); and CSU = reported CSU (at la) associated with XI and X2
Jcsult+csulz
(ig/L Microgram per liter
CSU Combined standard uncertainty
EPA United States Environmental Protection Agency
pCi/L Picocurie per liter
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Table 2-4 - Typical Data Quality Indicators for Gamma Scanning (Under Development)
Table under development.
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ASSESSMENT AND OVERSIGHT
This section describes NAUM program oversight efforts to verify that information
gathered from field activities meet the intended use of the information.
Assessment and Response Actions
The following subsections describe the assessments and corresponding response actions for
oversight of sampling activities.
Audits
Audits shall be conducted periodically to assess conformance to this QMP and the project-specific
Work Plan. Any changes and deviations from this QMP or project-specific Work Plan during field
activities will be documented. Corrective action procedures will be implemented when deviations
that could potentially impact data quality and usability are noted by project personnel outside the
formal assessment process. Any such incidents will be documented and resolved using the
procedures and personnel that were detailed for planned assessments.
The two specific types of audits that will generally be performed are project audits and field audits.
These audits will be performed on an as-needed basis.
Project Audits
Project audits will be conducted to evaluate the quality, completeness, and timeliness of individual
project task assignments. Audits will be conducted, and nonconformance issues will be reported
in compliance with the project-specific Work Plan and QAPP.
Field Audits
Field audits are conducted to ensure that field personnel are adhering to proper sampling,
administrative, and health and safety SOPs. Field audit considerations should include sample
documentation; sampling plan adherence; equipment operation, maintenance, and calibration;
proper handling of standards, calibration gases, and preservatives; sampling techniques;
decontamination methods; data management and review; sample custody; packing and shipment
procedures; and health and safety practices. Field audits will be conducted on a random basis and
in response to reports or findings of poor performance or noncompliance with this QMP,
project-specific Work Plan, or sound engineering practices.
Performance and System Audits
Technical systems and performance audits will be performed as independent assessments of
sample collection and analysis procedures, if necessary (i.e., when there is incomplete performance
or audit history). Audit results will be used to evaluate the ability of the laboratory or field sampling
contractor to:
Produce data that fulfill the objectives established for the project
Comply with the QC criteria presented in this QMP
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Identify any areas requiring corrective action
The systems audit is a qualitative review of the overall sampling or measurement system while the
performance audit is a quantitative assessment of a measurement system and includes both internal
and external audits. EPA program and project personnel will conduct internal audits with
contractor support as necessary.
Nonconformance and Corrective Actions
Corrective action is the process of identifying, recommending, approving, and implementing
measures to counter unacceptable procedures or out-of-control performance that may affect data
quality. The RPM is responsible for overseeing, documenting, and verifying the adequacy of
implementation of any corrective action. If requested, the QA staff can assist the RPM in verifying
that the corrective action has been implemented. To correct a quality problem or work deficiency,
corrective action should generally be taken at the time the problem is identified. The individual
who identifies the problem will be responsible for notifying the appropriate project- or
program-level personnel. Corrective actions should not be initiated without prior communication
of findings through the proper channels.
Any nonconformance with the established QC procedures specified in the project-specific Work
Plans or this QMP will be identified and corrected in accordance with the applicable planning
documents. Once implemented, corrective actions must be documented in the field logbook or
project-specific location.
The goals of corrective action are to resolve the immediate problem, prevent future occurrences of
the problem, and improve processes. Significant problems with corrective actions should be shared
with other NAUM RPMs in regular section or branch meetings. A system for issuing, tracking,
and documenting the completion of formal corrective actions will be developed in the future..
The following three special and rare types of corrective action are highlighted for management
attention:
Unusual patterns of significant problems for EPA-lead projects: the RPM will inform the
EPA Contracting Officer, and NAUM management, and if applicable, the RQAM.
Failures that appear to be intentional and significant: the RPM will consult with NAUM
management and specifically consider whether the EPA OIG should be informed.
First-hand receipt of whistleblower fraud allegations: the RPM will immediately report by
email to NAUM management and the EPA OIG.
Reconciliation of Data with Data Quality Objectives
Assessment of data quality is an ongoing activity throughout all phases of a project. The following
outlines the methods to be used by the contractor for evaluating the results obtained from the
project.
Review of the DQO outputs and the sampling design should be conducted by project personnel
prior to sampling activities designated in project-specific Work Plans. The reviewer will submit
comments to the appropriate project personnel for action, comment, or clarification. This process
will be iterative.
A preliminary data review will be conducted by appropriate project personnel. The purpose of the
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review is to look for problems or anomalies in the implementation of the sample collection and
analysis procedures and to examine QC data for information to verify assumptions underlying the
DQOs and the project-specific Work Plan (including the Field Sampling Plan and QAPP). When
appropriate to sample design, basic statistical quantities may be calculated, a statistical hypothesis
test conducted, and assumptions underlying the test identified.
Data collected during the field activities should be reconciled with the requirements of the data
user. The end users may perform statistical evaluations to determine confidence levels along with
a subjective evaluation of the data qualifiers, which will determine any bias or skewing of the
results and usability of the data for the overall project.
If the validated data are determined to be not usable for the project or the data are found to have
deviated significantly from the DQI goals, the impacts will be documented. If critical data points
are affected that impact the ability to complete the project objectives, the data users will report
these findings immediately to the appropriate project personnel to discuss potential corrective
actions.
Field Oversight
The Tribal Land Cleanup and Remedial Support Branch field oversight program is implemented
to deter fraud, prevent systematic problems, ensure compliance with approved planning documents
such as a SOP or QAPP, and promote best practices for work quality and safety. Field oversight
comprises spot checks, surveillance, triggered checks, and field audits; see Section 3.2.1 for
definitions of these activities. As the quality of environmental work is strongly affected by
non-technical factors, which are often site-specific factors, the Tribal Land Cleanup and Remedial
Support Branch's oversight of NAUM cleanup projects is primarily project specific.8
The Tribal Land Cleanup and Remedial Support Branch's NAUM project oversight must be
performed by personnel independent of those performing the work. An EPA RPM, an EPA
contractor, or a Navajo Nation or other government agency staff member who is part of the project
planning team typically meet this independence requirement.
EPA often uses contractors for field oversight of potentially responsible party (PRP) work;
however, when an EPA contractor performs site work, the EPA Task Order Contracting Officer's
Representative (usually the EPA RPM) should perform all necessary field oversight.
The level and type of effort for field oversight is commensurate with risks of an incorrect EPA
decision, public concern, available resources, and project-specific evaluation factors as described
below.
Types of Field Oversight Activities
A spot check is a random check of in-progress activities at a time and place convenient to the
person performing the oversight without negatively affecting work schedules or quality. These
checks would normally be used to decide if an additional level of oversight should be performed.
Spot checks are normally performed by an EPA RPM or delegate and documented in a field
notebook. Documentation can include only summary information or specific, detailed
8 Guidance to develop a project-specific oversight approach is considered more effective than program-wide
prescriptive requirements for field oversight for a variety of reasons, including 1) the quality of work processes
vary with site-specific human factors and 2) site-specific risk and benefit considerations directly impact the level
of assurance EPA needs to provide stakeholders.
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observations. A spot check differs from a surveillance in that a spot check is focused on one
particular component of QA and generally involves asking questions, inspecting documentation,
and comparing any gathered information against a standard of performance, such as a SOP.
A surveillance is a planned visual inspection of field operations with a focus on the overall
management practices that generally relies on the judgment and experience of the RPM or
delegate. Typically, a surveillance will 1) confirm the presences of appropriate equipment and
staff, 2) confirm the location and time of activities, 3) observe whether management and
implementation practices appear efficient and organized, 4) confirm that samples are appropriately
stored under custody and with proper preservation, and 5) confirm that any critical checks specified
in the umbrella QAPP or task-specific SOP are being performed (e.g., required calibrations occur
timely, subcontractor oversight by a technically qualified person, etc.). Often, multiple field
operational activities occur in parallel, and a surveillance will have a goal of broad coverage of
each type of activity or work that has the most impact on subsequent decisions, such as observing
each sampling team or activity as appropriate. Surveillance activities can be documented in field
notebooks, a completed checklist, or, for concerns that may require additional follow-up, a brief
field report or memorandum summarizing findings. Surveillance activities may take place for a
portion of or all of a field sampling event.
A triggered check is a planned oversight activity to directly verify or refute a significant
nonconformance concern or other special circumstance. For example, if samples were previously
received by a laboratory in broken bottles, the RPM may inspect all shipping containers for
appropriate shipping precautions and interview the samplers to determine whether practices need
to be changed. These checks can be performed by an EPA RPM, an EPA contractor, or other
government agency personnel. Triggered checks can be documented in field notebooks, a
completed checklist, or, for significant concerns with nonconformance findings, a formal field
report or through the initiation of a corrective action process.
A focused audit is a formal planned review of a specific site process and generally used when
passive visual observation alone is inadequate to verify the acceptability of work and the work
quality cannot be established by routine supporting documentation. Generally, these audits are
based on SOPs, employ checklists, and result in a formal report. Example focused audits include
sampling audits and split sampling. Focused audits are typically initiated by the NAUM program
or QAB and generally performed as a response to project-specific findings or as part of a program-
wide requirement. Audits are generally planned activities because they involve extensive
interaction with field personnel and have an impact on project schedules.
Field Oversight Goal
Generally, the purpose of field oversight is to independently and affirmatively corroborate9 that
field work is performed in accordance with umbrella planning documents, such as a QAPP or
Health and Safety Plan (HASP), and to ensure that there are no unanticipated circumstances that
could affect work quality. The Tribal Land Cleanup and Remedial Support Branch has a minimum
field oversight goal for certain oversight activites10 as described in Table 3-1. The minimum
9 As opposed to independent verification and assessment of the acceptability of each step of a process, all steps of a
process, or all aspects of a project that could vary from planning expectations.
10 The oversight goal reflects that some minimum level of affirmative information is needed to validate the quality
of EPA decisions for stakeholders. These oversight goals describe a minimum effort on a program-wide basis that
would generally occur in the situation where no actual or perceived quality concerns are found for a NAUM
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oversight goal is developed to provide the NAUM program with a regular assessment of the quality
of field work, which allows for continuous quality improvement.
Field oversight typically has a focus on aspects of data collection that can only be verified in the
field and complements other oversight activities performed in the office, such as data assessment
and documentation reviews.
The oversight approaches and actions for trustee-lead projects are developed in partnership with
NNEPA; however, oversight for all projects should be coordinated with NNEPA so that the agency
can participate when available. Field oversight for data collected under an EPA grant or as a time-
critical action are not subject to a minimal level of EPA oversight.11
Program-Wide Field Oversight
An annual assessment of oversight implementation will be made by Tribal Land Cleanup and
Remedial Support Branch management in the first quarter of every fiscal year. Oversight
implementation will depend on the number, type, and goals of field activities planned for the year.
As described in Table 3-1, for PRP and trustee projects, the NAUM Program has a minimum goal
of one split sampling event per year and one field audit event per year on a program-wide basis.
In addition, the Program has a minimum goal of perform a field audit on an annual basis for EPA
projects. Branch management will decide which projects will be used to meet the program-wide
goal.
Project-Specific Field Oversight
Project-specific oversight approaches should be developed within budget, time, and resource
limitations. Frequently, general approaches used in recent similar NAUM projects are an
appropriate starting point. Site-specific concerns or special circumstances may arise that influence
the type and frequency of oversight activities required to meet oversight goals. An important factor
to consider is who will perform specific activities to ensure both independent and competent
oversight occurs. The EPA RPM should be alert for and identify vulnerabilities or processes that
vary unacceptably and would have the most significant negative impact on project decisions. To
meet these objectives, EPA RPMs often strategically apply support from contractors or other EPA
and governmental organizations.
project. There is no maximum or typical level of field oversight. However, if no problems are found, no additional
oversight activities are triggered on a project-specific basis. Establishing minimum oversight goals rather than
required oversight specifications eliminates the risk of unnecessarily slowing down a cleanup or misallocating
human and financial resources where they may not be needed.
11 Data collected underan EPA grant are covered by terms and conditions forthe grant. Data collected as time-
critical or emergency actions are only subject to oversight determined as appropriate by the project RPM or OSC.
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Table 3-1 - Program Minimum Oversight Goal and Responsibility
Oversight
Activity
Project
Type
Approach
l-'requencv
Responsibility
Surveillance
PRP Lead
Trustee Lead
EPA Lead
Project-specific
Project-specific
Project-specific
Every sampling event
Every sampling event
Every sampling event
RPM
RPM
RPM
Split
sampling
PRP Lead or
Trustee Lead
Program-wide
1 sampling event per year
Designated RPM1
Field audit
PRP Lead or
Trustee Lead
Program-wide
1 sampling event per year
Designated RPM
EPA Lead
Program-wide2
1 sampling event per year
Designated RPM
Notes:
1 The designated RPM is the RPM for the project identified to fulfill the program-wide oversight goal.
2 Program-wide EPA contractor oversight.
EPA United States Environmental Protection Agency
PRP Potentially responsible party
RPM Remedial Proj ect Manager
Field Oversight Responsibilities
Most of field oversight responsibility lies with individual RPMs (Table 3-1); however, the
approach is expected to vary as the program develops.
This QMP addresses how a contractor is used to perform field work for EPA. As one contractor
may work with multiple RPMs and multiple projects, EPA monitors system performance via
corrective action reports or performs assessment of work products. The regional QAB will monitor
internal corrective action reports, project-specific surveillance reports, data validation reports, and
the results of any audits. If a trend of poor performance is observed that is not project specific,
EPA will address the concern in a systematic way. For example, the Tribal Land Cleanup and
Remedial Support Branch could initiate focused audits of all or multiple projects and coordinate
with the regional QAB and the EPA Contracting Officer.
In cases where EPA personnel or other federal agency staff (e.g., the United States Coast Guard
[USCG], United States Geological Survey [USGS], etc.) perform actual field work, the QAB
approving the umbrella QAPP or the Tribal Land Cleanup and Remedial Support Branch Assistant
Director should initiate any oversight activities in consultation with the project manager designated
in the QAPP.
Specific field oversight responsibilities of management and staff are described in Table 3-2.
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Table 3-2 - Field Oversight Responsibilities
Tribal Land C lea 11 n p and Remedial Support lira noli Section and Branch Managers are
responsible lor ihe following program o\ersighl
Ensure annually that program-wide minimum oversight goals are met
Ensure that meetings are held regularly to share project-specific oversight findings
Provide guidance to RPMs on the type and level of field oversight in response to new or
unusual vulnerabilities identified
Verify reasonableness and program-wide consistency of project-specific field oversight
Plan program-wide EPA field oversight activities to adequately address vulnerabilities
during the first quarter of every fiscal year
Ensure that any whistleblower complaints are reported to the EPA Office of Inspector
General
NAl'M Project Managers (KP.M/OSC ) are responsible for the follow inu project-specific
lleld o\ersiuhl aeli\ ities
Initiate any oversight activity
Coordinate and ensure implementation of activities
Ensure that properly qualified personnel are performing activities (technically competent
and independent)
Document oversight activities, findings, and actions taken and include this documentation
in the project site file
Develop and/or approve of corrective actions required to resolve quality issues
Ensure the appropriate response to any oversight finding
Share oversight findings with other Tribal Land Cleanup and Remedial Support Branch
RPMs and, as appropriate, partner agencies
The QAIJ is re sponsible for the following RP\1 support for Held o\ersiuhl
Inform RPMs of poor-quality planning documents that have been submitted for review,
primarily in areas of internal management practices, technical SOPs, and quality control
Inform RPMs about any quality concerns detected in data assessments and validations
Make recommendations to RPMs that address findings from periodic checks of EPA
contractor quality assurance corrective actions
Assist the Tribal Land Cleanup and Remedial Support Branch in updating program
planning documents, such as this QMP
Ensure consistency in project-specific planning documents with overall QMP goals
Notes:
EPA United States Environmental Protection Agency
NAUM Navajo abandoned uranium mine
OSC On-Scene Coordinator
QAB Quality Assurance Branch
QMP Quality Management Plan
RPM Remedial Project Manager
SOP Standard operating procedure
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Field Oversight Tools and Considerations
To assist the RPM with field oversight responsibilities and documentation, an example checklist
is included in Appendix C. This checklist provides a comprehensive list of process elements for
RPM surveillance; however, the specific subset of elements to be checked is determined by the
RPM. This checklist does not take the place of any site-specific HASP checks. The RPM can use
the Field Surveillance Checklist, modify the checklist, or document oversight activities in another
way, such as entries in a logbook. The documentation should be included in the site file in the
Superfund records center to document that QA activities are appropriately implemented in the
field. If field oversight activities uncover QA areas of concern, in addition to implementing
corrective actions, the RPM may want to consider additional tools, such as a triggered check or a
focused audit. If the concern is minor and easily addressed, the corrective action could be
immediately implemented in the field at the time the concern is identified with appropriate written
documentation of the change. However, if the concern is more complex, the RPM may need to
consult with the project QAB to determine an appropriate course of action, which may include a
focused audit. Additional tools for gamma scanning activities are under development.
Table 3-3 lists the noted problems in historical Region 9 CERCLA programs and serves as a
starting point for oversight planning for RPMs. Root causes of QA problems often are lack of
effective communication, lack of adequate training, and lack of available resources (time, people,
and equipment).
Resources for Planning and Implementing Field Oversight
Project oversight must be performed by personnel independent of those performing the work. The
following resources typically meet this independence requirement and can be used to plan and
implement field oversight of the NAUM Program:
EPA Emergency Response Team
EPA ORIA
EPA Oversight Contractor (for PRP-lead projects)
EPA Region 9 Technical Support Team
EPA Region 9 Field Team
EPA Region 9 QAB
NNEPA
USCG
USGS
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Table 3-3 - Noted Problems in CERCLA Programs and Oversight Considerations
Kreqiienev .
Problem (T.UCI.A °M Held Oversight Strategv
.... . Decisions
\\ ide
Inadequate sample
preservation
High
Low to severe
Spot check
Unreadable sample labels
Moderate
Low to severe
Spot check
Incomplete chain of custody
Moderate
Low to severe
Spot check
Rushed workload with
increased risk for errors
Moderate
Low to severe
Surveillance, spot check
Inadequate care for cross-
contaminati on/ cl eaning
Moderate
Low to severe
Spot check, focused audit on
sampling technique
Improper field QC
Moderate
Low to severe
Spot check
Switched samples
Low
Moderate to
severe
Focused audit on
organization
Significant field variances
Low
Moderate to
severe
Triggered check, corrective
action process, focused audit
based on findings
Out of spec field instrument
calibration
Low
Low to severe
Spot check, field
Performance Evaluation1
sample
Inexperienced samplers
Low
Low to severe
Spot check
Inadequate sampling
volume
Low
Low to severe
Spot check
Improper use of field
instruments
Low
Low to severe
Spot check
Sample location error (e.g.,
GPS error)
Low
Low to severe
Spot check, focused audit on
experience and procedures,
independent location record
Field variances (low
significance) without
documentation and approval
Low
Low
Triggered check,
surveillance
Slow work because of poor
organization/preparedness
Low
Low to
moderate
Surveillance, spot check
Unsupervised subcontractor
Low
Low to
moderate
Spot check
Deliberate falsification of
sample location
Very low
Severe
Deterrence by split sampling,
spot check
Notes:
1 Performance Evaluation samples are used to test the proficiency of an analytical method or field measurement
procedure
CERCLA Comprehensive Environmental Response, Compensation, and Liability Act
GPS Global positioning system
QC Quality control
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Reports to the Project Manager
The Project Manager will receive reports from designated project personnel on programmatic
issues as they occur. The roles and responsibilities of project management personnel will be
defined in the project-specific Work Plan. Generally, Project Managers will receive reports on all
issues that arise during the project that could affect data quality, data use objectives, project
objectives, or project schedules. The types of reports that could be supplied to both program and
project management personnel include the following:
Field audit
Laboratory audit
Field activities summary
Project status calls and meetings
Data validation report
Data usability report
DATA VALIDATION AND USABILITY
Data Review and Validation
Data validation will be performed according to EPA's Region 9 Superfund Data
Evaluation/Validation Guidance (EPA 2001c) and Section 1.4.3. Upon completion of validation,
data will be classified as one of the following: acceptable for use without qualifications, acceptable
for use with qualifications, or unacceptable for use. Analytical data will primarily be generated by
commercial analytical laboratories.
Data Review and Validation Procedure
Data review is the process to evaluate whether 1) analytical data are generated and documented in
a technically sound and defensible manner; 2) analytical data meet the applicable QC criteria; and
3) data usability and the extent of impact to the data from technical deficiencies and QC outliers
are acceptable through independent verification.
Data packages are reviewed for technical deficiencies or potential issues impacting the validity of
the reported results depending on the analytical program and validation level. The basic procedure
is as follows:
Determine the completeness of data package
Evaluate the data for DQIs and issues that could impact reliability or usability
Apply appropriate qualifiers to data
Prepare the validation report
Complete an internal review of validation report
Submit the validation report
Finalize the validation report
Variances from the QA/QC objectives will be addressed as part of the data validation summary
reports.
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Data Usability Assessment
The data usability assessment is considered the final step in the data evaluation process and
evaluates whether underlying assumptions used during systematic planning are supported, sources
of uncertainty have been accounted for and are acceptable, data are representative of the population
of interest, and the results can be used as intended with the acceptable level of confidence. The
following general steps will be followed to conduct a data usability assessment:
Step 1 - Review the project's objectives and sampling design
Step 2 - Review the data verification and data validation outputs
Step 3 - Verify the assumptions of the selected statistical method (if applicable)
Step 4 - Implement the statistical method (if applicable)
Step 5 - Document the data usability and draw conclusions
All data will be assessed for usability regardless of the data evaluation and validation process
implementation. Data usability goes beyond validation in that it evaluates the achievement of the
DQOs based on the comparison of the project DQIs and individual study-specific work plans with
the obtained results.
Primarily, the assessment of the usability will be conducted according to the process outlined
below.
1) Sampling and Analysis Activities Evaluation. The first part of the data usability
assessment will include a review of the sampling and analysis activities in comparison to
project-specific DQIs. Limitations to the data will be determined and documented.
2) Achievement of DQIs. The second part of the data usability assessment pertains to the
achievement of the project-specific DQIs. Designated project personnel will compare the
performance achieved for each data quality criterion against the expected and planned
performance. In general, this comparison will follow from the DQIs used to define each
DQO. This comparison is the most critical component of the assessment process. Any
deviation from planned performance will be documented and evaluated to determine
whether corrective action is advisable. Potential corrective actions will range from
resampling and reanalyzing the data to qualification or exclusion of the data for use in the
data interpretation. If corrective action is not possible, any limitations of the data with
regard to achieving the DQOs will be noted.
In conjunction with the DQI achievement review, decisions for the use of qualified values
must be considered. Data qualifiers are applied to individual data results, and data usability
decisions should be made based on the assessment of the usability of each of these results
for their intended purpose. The evaluation will describe the uncertainty (bias, imprecision,
etc.) of the qualified results. Cumulative QC exceedances from the DQIs may require
technical judgment to determine the overall effect on the usability of the data. Finally, data
users may choose to determine final data usability qualifiers as a result of this overall
examination and decision process.
3) Achievement of DQOs. The final part of the data usability assessment concerns the
achievement of the DQOs. Once the data set has been assessed to be of known quality, data
limitations have been documented, and overall result applicability and usability for its
intended purpose has been determined, the final data assessment can be initiated by
determining if the DQOs have been achieved.
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Where data gaps are identified as a result of problems, biases, trends, etc., in the analytical data,
or if conditions exist that were not anticipated in the development of the DQOs, a solution or
corrective action should be formulated. It is particularly important that each data usability
assessment specifically address any limitations on the use of the data that may result from a failure
to achieve the stipulated DQO.
When the data do not meet the project DQOs, the root cause to the deficiency should be
investigated. Reasons could include laboratory operation, such as the failure of laboratory RLs to
meet site criteria. Corrective actions may include:
Resampling for all or some of the parameters
Preparing a technical memorandum detailing limitations to the data
Validating the data at a higher tier level to better qualify the results
Preparing a technical memorandum determining the bias of field results
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RELEVANT PROGRAM GUIDANCE
EPA Policy and Program Requirements for the Mandatory Agency-Wide Quality System, EPA
Order, CIO Policy 2105.0 (EPA 2000a).
EPA Requirements for Quality Assurance Project Plans, EPA QA/R-5, EPA/240/B-01/003
(EPA 2001a).
EPA Guidance for Quality Assurance Project Plans, EPA QA/G-5, EPA/R-02/009 (EPA 2002a).
EPA Guidance on Systematic Planning Using the Data Quality Objectives Process, EPA QA/G-4,
EPA/240/B-06/001 (EPA 2006).
EPA Region 9 Quality Management Plan (EPA 2014).
EPA Region 9 Guidance for Quality Assurance Program Plans, EPA R9QA/03.2 (EPA 2012).
EPA Region 9 Laboratory Documentation Required for Data Evaluation, EPA R9QA/004.2
(EPA 2001b).
EPA Region 9 SuperfundData Evaluation/Validation Guidance, EPA R9QA/006.1 (EPA 2001 c).
EPA Multi-Agency Radiological Laboratory Analytical Protocols (MARLAP) Manual, EPA 402-
B-04-001A (EPA 2004).
EPA Multi-Agency Radiation Survey and Site Investigation Manual (MARSSIM), EPA 402-R-97-
016 (EPA 2000b).
EPA Test Methods for Evaluating Solid Waste: Physical/Chemical Methods, Third Edition, Final
Update III-A, EPASW-846-3.3a, March (EPA 1999).
EPA Methods for the Determination of Inorganic Substances in Environmental Samples,
EPA/600R-93-100 (EPA 2002b).
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REFERENCES
American Nuclear Society. 2012. Verification and Validation of Radiological Data for Use in
Waste Management and Environmental Remediation. ANSI/ASI-41.5-2012.
California Military Environmental Coordination Committee. 1997. Best Practices for the
Detection and Deterrence of Laboratory Fraud. Version 1.0. March
United States Environmental Protection Agency (EPA). 1980. Prescribed Procedures for
Measurement of Radioactivity in Drinking Water. EPA/600/4-80-032. August.
EPA. 1999. EPA Test Methods for Evaluating Solid Waste: Physical/Chemical Methods. Third
Edition, Final Update III-A. EPA SW-846-3.3a. March.
EPA. 2000a. EPA Policy and Program Requirements for the Mandatory Agency-Wide Quality
System. EPA Order, Chief Information Officer (CIO) Policy 2105.0. May 5.
EPA. 2000b. Multi-Agency Radiation Survey and Site Investigation Manual. EPA 402-R-97-016,
Rev. 1. August.
EPA. 2001a. EPA Requirements for Quality Assurance Project Plans. EPA QA/R-5, EPA/240/B-
01/003. March.
EPA. 2001b. Laboratory Documentation Requirements for Data Evaluation. EPA Region 9.
EPA R9/QA/00.4.2. August.
EPA. 2001c. Region 9 Superfund Data Evaluation/Validation Guidance. EPA R9/QA/006.1.
December.
EPA. 2002a. Guidance for Quality Assurance Project Plans. EPA QA/G 5, EPA/R-02/009.
December.
EPA. 2002b. Methods for the Determination of Inorganic Substances in Environmental Samples.
EPA/600R-93-100. December.
EPA. 2004. Multi-Agency Radiological Laboratory Analytical Protocols Manual. EPA 402-B-04-
001A. July.
EPA. 2006. Guidance on Systematic Planning Using the Data Quality Objectives Process. EPA
QA/G-4, EPA/240/B-06/001. February.
EPA. 2012. EPA Region 9 Guidance for Quality Assurance Program Plans. EPA R9QA/03.2.
March.
EPA. 2014a. Region 9 Quality Management Plan. October.
EPA. 2014b. EPA QA Field Activities Procedure. CIO Directive 2105-P-02.0. September.
United States Nuclear Regulatory Commission. 1998. Minimum Detectable Concentrations with
Typical Radiation Survey Instruments for Various Contaminants and Field Conditions.
NUREG-1507.
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ACRONYMS AND ABBREVIATIONS
ANSI American National Standards Institute
ASPECT Airborne Spectral Photometric Environmental Collection Technology
ASTM ASTM International
AUM Abandoned uranium mine
CERCLA Comprehensive Environmental Response, Compensation, and Liability Act
CIO Chief Information Officer
CSU Combined standard uncertainty
DMP Data Management Plan
DOD United States Department of Defense
DOE United States Department of Energy
DQI Data quality indicator
DQO Data quality objective
EPA United States Environmental Protection Agency
ERT Environmental Response Team
GIS Geographic information system
GPS Global positioning system
HASP Health and Safety Plan
MAPEP Mixed Analyte Performance Evaluation Program
MARLAP Multi-Agency Radiological Laboratory Analytical Protocols
MARS SIM Multi-Agency Radiation Survey and Site Investigation Manual
MDC Minimum detectable concentration
MDL Method detection limit
mL Milliliter
MQC Minimum quantifiable concentration
MQO Measurement quality objective
MS Matrix spike
MSD Matrix spike duplicate
NAUM Navajo abandoned uranium mine
NAREL National Analytical Radiation Environmental Laboratory
NIST National Institute of Standards and Technology
NNEPA Navaj o Nation Environmental Protection Agency
NRC Nuclear Regulatory Commission
ORC Office of Regional Counsel
OIG Office of Inspector General
OLEM Office of Land and Emergency Response
ORIA Office of Radiation and Indoor Air
OSC On-Scene Coordinator
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PARCCS
Precision, accuracy, representativeness, comparability, completeness, and
sensitivity
PRP
Potentially responsible party
QA
Quality assurance
QAB
Quality Assurance Branch
QAO
Quality Assurance Officer
QAPP
Quality Assurance Project Plan
QC
Quality control
QMP
Quality Management Plan
QSM
Quality Systems Manual
RL
Reporting limit
RPD
Relative percent difference
RPM
Remedial Project Managers
RQAM
Regional Quality Assurance Manager
SAP
Sampling and Analysis Plan
SOP
Standard operating procedure
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Appendix A-l
Example QAPP Signature Block Template
PRP-Lead, RSE type QAPPs (see Table 1-4)
Insert Document Title
Prepared by:
Approved by: Contractor, Project Manager Phone Date
Approved by: Contractor QA Officer Phone Date
For EPA use:
Approved:
{Insert Name) EPA Proj ect Manager, Date
Received by QA Branch: Date:
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Appendix A-2
Example QAPP Signature Block Template
Trustee-Lead type QAPPs (see Table 1-4)
Insert Document Title
Prepared by:
Approved by: Contractor, Project Manager Phone Date
Approved by: Contractor QA Officer Phone Date
Approved:
{Insert Name) EPA Proj ect Manager, Date
{Insert Name) Navaj o EPA Proj ect Manager, Date
Received by QA Branch: Date:
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Appendix A-3
Example QAPP Signature Block Template
EPA Funded Interagency Agreement/Grant,
EPA-Lead Final Status Survey (See Table 1-4)
Insert Document Title
Prepared by:
Approved by: Contractor, Project Manager Phone Date
Approved by: Contractor QA Officer Phone Date
For EPA use:
Approved by: {Insert Name), EPA Project Manager Phone Date
Received by QA Branch: Date: Expedited review? ~ Yes DNo
Reviewed by:
Region 9 QA Reviewer Date
Approved:
EPA Region 9
Navajo Abandoned Uranium Mines Program
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Region 9 QA Manager,
Date
EPA Region 9 Quality Management Plan
Navajo Abandoned Uranium Mines Program
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Appendix B
QAPP Review Checklist
EPA Region 9 Quality Management Plan
Navajo Abandoned Uranium Mines Program
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Appendix C
NAUM Field Surveillance Checklist
EPA Region 9 Quality Management Plan
Navajo Abandoned Uranium Mines Program
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Appendix C: Field Surveillance Checklist
Site Name:
Lead Agency:
Remedial Project Manager:
Work Order No.:
Date:
Time on Site:
Time off Site:
On-Site Field Group Personnel:
Affiliation
Name(s)
Abandoned Uranium
Mines Visited:
Global Positioning
System (GPS)
Coordinates:
Weather:
Temperature:
Summary of Activities:
EPA Region 9
Navajo Abandoned Uranium Mines Program
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Region/Office Division/Unit Name and Location:
Date(s) of Assessment:
Name(s)/Affiliation of Assessor(s):
General Requirement
Assessment
Source1
(I, O, D)
Assessor Comments
Y
N
NA
1 Personnel and Training
1.1 Personnel responsible for field activities have
appropriate qualifications, education, training, and
experience, and a satisfactory knowledge of the
requirements of the activities to be carried out.
2 Procedures - Availability
2.1 Field sampling and measurement activities are
conducted in accordance with applicable standard operating
procedures, quality assurance project plans (QAPPs), and
sampling and analysis plans.
2.2 All instructions, standards or written procedures,
worksheets, checklists, and reference data relevant to the
field investigations/inspections are current, accurate, and
readily accessible by the staff.
2.3 Key personnel identified in the QAPP are present and
implementing quality assurance checks identified in the
QAPP.
2.4 Field groups identify, document, and implement any
required corrective actions.
EPA Region 9
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General Requirement
Assessment
Source1
(I, O, D)
Assessor Comments
Y
N
NA
3 Records Management - Legibility and Traceability
3.1 Within the context of field oversight activities, records
provide objective evidence of actions taken and observations
made.
Examples of field records include (but are not limited to):
field logbook entries, electronic field measurement data log,
completed chain-of-custody forms, instrument calibration
and recalibration records, daily results of source checks and
performance chart comparisons, instrument damage or fault
reports, photographs, maps, completed inspection forms,
QAPPs, etc.
3.2 Field groups maintain and utilize established procedures
to ensure:
a) All records are legible and stored and retained in such a
way that they are readily retrievable, either electronically or
in hard copy format.
b) Observations, calculations, and measurement entries are
clearly and permanently recorded at the time they are made.
c) Technical records associated with field activities include
the identity of personnel responsible for the sampling or
inspection activities.
d) Each page of project-related records is traceable back to
the project.
e) Information that is to be included in files that contain
project records is defined.
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General Requirement
Assessment
Source1
(I, O, D)
Assessor Comments
Y
N
NA
f) Electronic records have back-up processes and protection
from unauthorized access or amendment.
g) Records that have been recorded manually are recorded in
permanent ink.
When weather conditions do not make it feasible to use
permanent ink, then entries can be made in non-smear
pencil. The penciled entries shall be captured permanently
by photocopying or photographing the penciled entries or
other acceptable manner.
h) Error corrections do not obliterate entries in the original
record.
Corrections are made by marking through the error with a
single line and then initialing and dating the correction.
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General Requirement
Assessment
Source1
(I, O, D)
Assessor Comments
Y
N
NA
4 Data Management - Custody and Security
4.1 Field groups maintain and utilize procedures for the
identification, transportation, handling, protection, storage,
and retention of samples and other appropriate
environmental data during field activities.
The procedures ensure:
a) Field samples and appropriate environmental data are
maintained under custody at all times during field studies,
investigations, and inspections.
Samples and data are in custody if they are:
i) Within the direct possession or the control (i.e., within the
view) of an individual designated to have sample handling
responsibilities
ii) Placed in a designated secure area to prevent tampering
iii) Maintained in a manner that ensures the integrity of the
samples is not compromised when placed in an unsecure
area.
b) All samples, measurements, and other appropriate data
are uniquely identified to ensure items cannot be confused
physically or when referred to in records or other
documents.
c) A chain-of-custody record shall be maintained for the
collection of environmental samples that details each person
who takes possession of the samples.
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General Requirement
Assessment
Source1
(I, O, D)
Assessor Comments
Y
N
NA
d) If electronic systems (i.e., bar coding of potential
evidence/samples, Scribe, etc.) are used for sample labeling
or chain-of-custody generation, hardcopy/manual systems
should be available in the event of the failure of the primary
electronic system or device.
5 Field Documentation - Completeness
5.1 For field measurements and sample collection,
documentation includes, as appropriate, but is not limited to:
a) Date and time of measurement or sample collection.
b) Location description and/or global positioning system
(GPS) coordinates.
c) Measurement/sample identification.
d) Measurement/sample collection method.
e) Measurement/sample collection equipment used,
including identification numbers and the manufacturer
name/model number as appropriate.
f) Calibration standards, buffers, etc., including
manufacturer, lot numbers, and expiration date.
g) Initial and continual calibration data and meter end
checks.
h) Measurement values for non-logging equipment.
i) Sample containers (number and type).
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General Requirement
Assessment
Source1
(I, O, D)
Assessor Comments
Y
N
NA
j) Sample preservation (chemical, ice, etc.).
k) Physical description of matrix measured or sampled.
1) Maps/sketches.
m) Conditions that may adversely impact the quality of
measurements/samples if applicable (for example,
radiological interferences [shine], rain, wind, smoke, dust,
extreme temperatures, etc.).
n) Photograph log.
6 Equipment - Validation/Certification
Field groups implement procedures for field equipment that
ensure:
a) All measurement equipment is uniquely identified (i.e.,
identification number).
b) Measurement equipment is calibrated before being put
into service and thereafter according to an established
procedure.
d) Up-to-date instructions on the use and maintenance of
measurement equipment, including any relevant manuals
provided by the manufacturer of the equipment, are readily
available for use by the appropriate personnel.
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General Requirement
Assessment
Source1
(I, O, D)
Assessor Comments
Y
N
NA
e) Equipment that has been shown to be defective or outside
specified quality control limits is taken out of service. Such
equipment shall be isolated to prevent its use and clearly
labeled/marked as being out of service until it has been
repaired and shown by calibration or test to perform
correctly.
f) Whenever practicable, equipment requiring calibration
shall be labeled, coded, or otherwise identified to indicate
the status of calibration, including the date when calibration
is due.
The date when last calibrated and performance chart
comparisons may also be included.
i) Records shall be maintained to document the check
sources, standards, reagents, etc. used to calibrate equipment
and may include, as appropriate, the manufacturer,
standard/reagent lot number, expiration date of the
standard/reagent; and date and activity of a check source.
Note:
11 = Interview; O = Observation; D = Documentation
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Appendix D
Radiochemical Data Validation SOP
EPA Region 9 Quality Management Plan
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Appendix E
Gamma Scanning Checklist
(Under Development)
69
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Appendix E
Gamma Scanning Checklist (Under Development)
Checklist Under Development
70
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