UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
REGION IX
75 Hawthorne Street
San Francisco, OA 94105
MEMORANDUM
Subject;
Region 9 Quality Management Plan (2014) Senior Management Signatures
To;
From:
Assistant Regional Administrator (MTS-1)
It is with great pleasure that I submit the Region 9 Quality Management Plan. This document
describes the Region's commitment to a technically astute and dynamic quality system that
supports all our environmental decisions. The Region 9 Quality Management Plan describes
Region 9's quality system; as a demonstration of the Region's alignment with the national
program; and as a model for state, tribal and other organizations to use as they develop their own
quality systems.
The underlying principle is that quality is everyone's responsibility. This year's National Honor
Awards announcement acknowledges the highest level of commitment to that principle by the
Region. The Air Quality Analysis and Quality Assurance Technical System Audit Team won
the Barbara Metzger Environmental Data Quality Assurance Manager and Team Award and the
Contracts Management Award went to the Region 9 Remedial Action Contract (RAC) Award
Team that included two members of the Quality Assurance staff.
If you have any questions, please contact Eugenia McNaughton (415-972-3411,
.in ciiaughton.euKcn ia@epa. gov) of my staff.
-------
REGION 9 QUALITY MANAGEMENT PLAN
September 2014
CONCURRENCE:
0 -c^f^r £ l^rTf
Jajpd Blumenfeld \J Date
Regional Administrator
c,^jjtk^icrv-A
ck— S erena Mcllwain Date
I Assistant Regional Administrator
^ f/nf//
Eugenia McUaughton, Manager (/ Date
Quality Assurance Office
-------
Contents
EXECUTIVE SUMMARY 6
FOREWORD 7
1.0 Quality System Foundation 7
1.1 Regional Quality Assurance Goals and Policies « 7
1.1.1 Quality Assurance Basic Goals 8
1.1.2 Quality Assurance Policies . 8
2.0 -Region 9 Organization 9
2.1 Regional Administrator 9
2.2 Assistant Regional Administrator/Senior Information Officer 10
2.3 Senior Management 10
2.4 Regional QA Manager 10
2.4.1 Mandatory Independence of the Regional Quality Assurance Office .11
2.5 Quality Assurance Office 12
2.6 Regional Organizations with QA responsibilities 13
2.6.1 Air Division 13
2.6.2 Enforcement Division 14
2.6.3. Land Division........... 14
2.6.4 Management and Technical Services Division i 4
2.6.5 Office of Public Affairs 15
2.6.6 Office of Regional Counsel 15
2.6.7 Superflmd Division 15
2.6.8 Water Division 16
3.0 Regional Quality System 16
3.1 Overview................ ..16
3.1,1 The Graded Approach ........16
3.2 System Level Planning 17
3.3 Program Level Planning 17
3.3.1 Graded Approach at the Organization or Program Level 17
3.4 Project Level Planning 18
3.4.1 Scoping Meetings 18
3.4.2 Setting Project Data Quality Objectives 18
3.4.3 Graded Approach at the Project Level 19
3.5 QA Annual Planning 19
3.5.1 Regional QA Planning Process,.,.. 19
3.5.2 National QA Planning Process 20
3.5.3 QA Office Planning Process 20
3.6 Planning Documentation 20
3.6.1 Policies 20
3.6.2 Types of QA Planning Documents 21
3.6.3 Review and Approval of QA Planning Documents 22
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 Office Review Process 23
4.2.2 Other Document Review 24
4.3 Training 24
iii
-------
4.3.1 Quality Assurance Office Staff Competency 24
4.3.2 In-House and External Training 25
4.4 Procurement of Items and Services 25
4.4.1 Procurement Activities 25
4.4.2 Contracts Involving Environmental Measurements 25
4.4.3 Grants and Financial Assistance Agreements 26
4.4.4 Interagency Agreements 27
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 S tandards for Computer Generated Data 31
4.6.3 Regional Environmental Data Storage and Retrieval 31
4.6.4 Geographic Information Systems 26 31
4.7 Laboratory Program 32
4.7.1 Mission 32
4.7.2 Facilities 32
4.7.3 Delivery of Laboratory Services 33
4.7.4 Laboratory Quality Assurance Organization 33
4.7.5 Laboratory Quality Assurance System 33
4.8 Field Operations 34
4.8.1 Organization, Roles and Responsibilities 34
4.9 Standard Operating Procedures 36
4.10 Measurement Quality Objectives/Data Quality Indicators Tables 36
4.11 Information Quality Guidelines 37
4.12 Peer Review 37
5.0 Assessment 37
5.1 Overview 37
5.2 Assessment Tools 39
5.2.1 Management System Reviews (MSRs) 39
5.2.2 Technical Systems Audits (TSAs) 40
5.2.3 Performance Evaluation Samples (PEs) 41
5.2.4 Data Review: Verification and Validation 42
6.0 Quality Improvement 43
6.1 Planning documents 43
6.2 Training 43
6.3 Audits 43
6.4 Standard Operating Procedures 43
APPENDIX A 44
APPENDIX B 46
APPENDIX C 49
-------
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 supports Agency decisions
with data of known quality that may be presented with the confidence that they are
credible and defensible. Each Program and Region has a Quality Management Plan that
describes its commitment to and support of its quality system. Its 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 funds from EPA to perform
environmental data collection.
The Quality Assurance Office reviews and revises the Quality Management Plan every
five years. The Manager asks all Divisions and Offices to review it, particularly as it
addresses their specific data collection-related activities, and to indicate by signature that
they agree to adhere to the commitments, roles and responsibilities that are described
therein. It is then submitted to the Quality Staff (Office of Environmental Information)
for review and approval.
The current version of the Region 9 Quality Management Plan reflects the many changes
that have taken place in the Region over the last five years. An Enforcement Division is
now in place and the Communities and Ecosystem and Waste Divisions merged to
become the Land Division. The document also includes Region 9\s responses to several
initiatives that have become policies addressing federal government, Agency and
Regional commitments 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 Field
Operations Guidelines Policy. These are also described in the Quality Management Plan.
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 Office to support the Quality system; Section 3, Quality System
describes the Region 9 Quality Assurance Office'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 that
comprise the Quality system as practiced by the Quality Assurance Office and other
Region 9 organizations, such as the Region 9 Laboratory and Enforcement Division and
other staff involved in taking environmental measurements.
6
-------
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 the Policy and Procedure for Environmental Data
Operations (CIO 2105 and CIO 2105-P-01 to have a strong 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 that are in place relating 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.
The System is employed throughout the life cycle of a project; 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 3.0,4.0 and
5.0 discuss the activities in detail; the appendices include organization charts of the
Regional Office and other organization charts that relate to Regional QA activities.
Section 6 affirms the commitment to maintaining a dynamic and responsive Quality
System.
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.
Responsibility for developing and overseeing the implementation of the System resides
with the QA Office (QAO). 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.
• Reliable and Defensible Decisions — Decisions made based on data of known
quality are more likely to be upheld if challenged.
7
-------
• 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
Program Plan (QAPrP), Quality Assurance Project Plan (QAPjP), Sampling and
Analysis Plan (SAP), Field Sampling Plan (FSP), or Work Plan (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 that use existing data or data from modeling or secondary
sources have an approved QA Plan. The plan specifies the quality system that
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
8
-------
laboratories generating environmental data used in Agency and Regional decision
making are competent to provide usable and defensible results.
• Region 9 Policies and/or Orders to strengthen on going field activities and to
implement a sustainable management system that incorporates all ten of the Field
Operations Group guidelines are in place by February 15, 2016
Overall responsibility for QA in Region 9 resides with the Regional Administrator, who
makes the commitment to ensure that 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 Assistant Regional Administrator (ARA), Management and Technical
Services Division (MTS) (see Appendix B). The ARA is independent of the Divisions
responsible for collecting environmental measurements, except for the Region 9
Laboratory that is in MTS. The RQAM supervises the Quality Assurance Office (QAO).
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 Division Air Quality Analysis (AQA) Office (see Section
2.6.1), the Enforcement Division (see Section 2.6.2), the Land 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 six Divisions: Air, Enforcement, Land, Management and
Technical Services, Superfund and Water (see Appendix C). The Region also maintains
a Laboratory in Richmond, California, and field offices in Los Angeles CA, San Diego
CA and Honolulu HI. There are place-based staff in Carson City NV and Phoenix AZ.
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).
9
-------
• Ensures that quality management activities are supported by resources adequate to
accomplish program goals.
2.2 Assistant Regional Administrator/Senior Information Officer
The Assistant Regional Administrator:
• Supervises the QAC), the Regional Laboratory, Comptroller and Information
Resources Branches, the Human Resources, Facilities/Health & Safety and Grants
Offices.
• Acts as a senior management liaison between the QAO and senior managers in
other divisions,
• Serves as the Senior Information Officer (SIO) 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.
• 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 QAO in the Management and Technical Services Division
(see Appendix B).
The Regional Quality Assurance Manager
• Serves as manager of the Regional QA Program and supervises a group of nine
professional employees.
• 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 all QA planning documents prepared by or on behalf of the Agency for
10
-------
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.
• Reviews and approves Funding Recommendations and prepares grant conditions
as needed relating to environmental data collection.
• Reviews and approves Interagency Agreements.
• Oversees QA training for internal and external organizations upon request.
• Prepares and submits annual reports to Regional management and Office of
Environmental Information Quality Staff. Reviews, revises and submits the QMP
to the Quality Staff 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. Represents Region 9 on the national
technical Field Operations Group (FOG).
2.4.1 Mandatory Independence of the Regional Quality Assurance Office
Neither the RQAM nor the QAO 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 Division 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 ARA, s/he may raise the issue to the ARA.
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 QAO report to the ARA, the two organizations are geographically and functionally
11
-------
separate. The Regional Laboratory has its own QA system, which the QAO audits every
other year.
2.5 Quality Assurance Office
A table of QA Office GS series, responsibilities and years in service can be found in
Appendix A. The Quality Assurance Office:
• Acts as point of contact for information relating to EPA QA concepts and
practices.
• Ensures that 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 those provisions in the Regional QMP that apply to oversight of
grantees and other 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
QAPrPs, QAPjPs, 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).
12
-------
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 Office of Enforcement
and Compliance and Region 9 Enforcement Division.
2.6 Regional Organizations with QA responsibilities
2.6.1 Air Division
The Air Division is responsible for implementing the provisions of the Clean Air Act
(CAA) within the geographic boundaries of Region 9, including the Mexican border. The
Air Program guides the federal management, implementation, 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 QAO to perform the ambient air monitoring quality
assurance functions required by the CAA such as Technical System Audits. The QAO
also provides technical support for air methods development and oversees a voluntary
quality improvement program through round-robin performance evaluation studies.
Grants managed by Programs in the Division are reviewed by the QAO to ensure quality
assurance planning document requirements are addressed. The QA Office reviews
internal QAPjPs and State and Tribal QMPs, QAPrPs and QAPjPs
(www.epa.gov/region9/air).
13
-------
2.6.2 Enforcement Division
The Region 9 Enforcement Division was created on February 11, 2013. The new
organization consolidates the region's civil enforcement responsibilities under the federal
air, water, waste, pesticides, and toxics statutes. The Environmental Justice and National
Environmental Protection Act programs are located in this Division. The QAO reviews
inspection SAPs.
EPA has undertaken a national effort to strengthen its field activities and to implement a
consistent management system that incorporates Field Operations Group guidelines no
later than February 15, 2016. The Field Operations Lead or Point of Contact (POC),
reporting to the Deputy Director of the Enforcement Division, 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/enforeeroenf). 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.
2.6.3. Land Division
The Land Division, a new division formed by bringing together the Community and
Ecosystem and Waste Divisions, 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 Communities (Tribes, Pacific Islands and Mexico
Border), Pollution Prevention (Toxics, Toxic Substances Control Act (TSCA), Pesticides
and Zero Waste (Federal Insecticide, Fungicide, Rodenticide Act (FIFRA), Asbestos
Hazard Emergency Response Action (AHERA), the Asbestos School Hazard Abatement
Act (ASHAA), Section 313 (Toxics Release Inventory) of the Emergency Planning and
Community Right-to-Know Act (EPCRA) and the Food Quality Protection Act (FQPA)
and the Resource Conservation and Recovery Act (RCRA) (Corrective Action Permits
and Underground Storage).
Grants managed by the Division are reviewed by the QAO to ensure quality assurance
planning document requirements are addressed fwww.epa.gov/region9/waste). The QAO
reviews data collection SAPs for several Land Division programs.
2,6.4 Management and Technical Services Division
The Management and Technical Services Division provides overall infrastructure support
and services for EPA Region 9, including its field offices, in the following areas; physical
space, contract and grant administration, financial, human resources, health and safety,
information resources, environmental analysis and quality assurance. The Division
provides leadership in strategic planning, performance tracking, and accountability. It is
responsible for audit management and the management integrity programs
14
-------
(www2.epa.gOv/aboutepa/organization-chart-qpas-pacific-southwest-office#mts). The
Division manages implementation of the Region's mandatory QA Program
(www.epa.gov/region9/qa), operates the Region 9 Laboratory
(www.epa.gov/region9/laboratorv) and provides scientific and technical support to the
Region.
2.6.5 Office of Public Affairs
The Office of Public Affairs 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 Information
Resources Branch and the QAO 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 (www.epa.gov/region9/mediacenter).
2.6.6 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 QAO provides attorneys with technical and QA-related information
(www.eDa.gov/region9/orc) upon request.
2.6.7 Superfund Division
The Superfund Division is responsible for implementing the Comprehensive
Environmental Response, Compensation and Liability Act (CERCLA) as amended by the
Superfund Amendments and Reauthorization Act (SARA) of 1986, the Brownfields
Initiative, the Emergency Planning and Community Right-to-Know Act (EPCRA), the
Clean Air Act 112(r) and the Oil Pollution Act (OPA) within EPA Region 9. The
15
-------
Division is charged with conducting all activities for these programs, except enforcement
litigation activities. The Division works with other federal, State, Tribal and local
agencies, and the private sector to correct uncontrolled hazardous waste site problems.
The Division coordinates with the QAO, Regional Laboratory and the Contracts Office.
The Emergency Response Team has an approved QMP to support quality assurance
requirements for data collection in emergency situations. Grants administered by the
Division in the Brownficlds program are reviewed by the QAO to ensure quality
assurance planning document requirements are addressed. The QAO reviews internal
QAPjPs and State and Tribal QMPs, QAPrPs and QAPjPs and provides technical support
for emerging issues, such as sampling design for vapor intrusion studies
fwww.epa.gov/region9/supcrfund).
2.6.8 Water Division
The Water 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 Division has the ultimate responsibility for assuring that the chemical, physical and
biological integrity of the region's waters are restored and maintained so that water
pollution does not constitute a threat to public health, safety, well-being and the
environment. The QAO 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 QAO
to ensure quality assurance planning document requirements are addressed. The QA
Office reviews internal QAPjPs and State and Tribal QMPs, QAPrPs and QAPjPs
(www, epa, go v/re gio n9/wa tc r).
3.0 Regional Quality System
3.1 Overview
It is Agency and Regional policy that systematic planning be used for all projects
involving collection of environmental measurements. Managers make decisions based on
information provided by staff, technical advice and regulatory requirements. The QAO
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 the 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. This approach applies to all stages of data generation activity and to the use
16
-------
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/qa/r-2). The Region 9 QMP is available on line at
www,epa,gov/reeion9/qmo. 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 theComprehensive 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
QAPrPs to allow appropriate technical and policy review of the steps being taken to
ensure that data generated are of known quality.
The QAPrP Cwww.epa.gov/region 9/qa/pdfs/mngmt-plan guidance 2012) 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 QAPjPs and SAPs.
3,3.1 Graded Approach at the Organization or Program Level
The QAO works with grantees and other organizations to determine the type of planning
document most appropriate for the program. The QAO may require that a QMP with
supporting QAPrPs, or a combination QMP/QAPrP be prepared. In some cases, a waiver
may be granted. For example, for Tribal organizations with grants in only one or two
media areas, preparation of QAPjPs may be sufficient. This 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 or a QAPrP is generally not resource effective. A State program
generally prepares a QAPrP, but may prepare a QMP or a hybrid QMP/QAPrP,
depending on the scope and the structure of its quality system. The QAO works with the
State or Tribal organization to determine the most appropriate planning document.
17
-------
As the QA function in the Region is centralized and the QAO assists all Divisions in
implementing the QMP, the Divisions are not required to prepare separate QAPrPs, 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 QAPrP 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 QAO. However, whenever appropriate, the
QAO 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 or his or her
designee, the EPA Task Manager if an EPA contract is involved, a representative of the
organization preparing the plan, and QAO staff.
The QAO 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 QAO 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 Q A/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/quality/qs-docs/g4-fmal.pdf), is the primary systematic planning tool for
18
-------
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.
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 QAPjP 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 QAO to develop an appropriate document.
3.5 QA Annual Planning
Annual planning for the QAO ensures that resources are used efficiently to accomplish
the Region's QA activities. Planning is undertaken at two levels: QAO goals are
included in the Region 9 Management and Technical Services Division Operating Plan
and annual planning goals are included in the Quality Assurance Annual Review and
Workplan (QAARWP) that is 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 QAO 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 QAO seeks input
from the divisions with which it works in preparing its Strategic Operating Plan.
19
-------
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 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 Quality
Staff 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 QAO 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 Quality Assurance Officers 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 arc required to have an
appropriate QA planning document approved by the QAO prior to the initiation of
data collection. The document is developed in accordance with regional and
national guidance, which is available on the QA Web page (http:/ /www
.epa.gov/region09/QA/r9-QAdocs.html).
• 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 QAO
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 up-
dated annually as necessary. After five years, they are reviewed and revised to
reflect the current activities being performed, and submitted to the QAO for
approval.
• A State program that has an approved QMP and/or QMP/QAPrP(s) in place that
has been evaluated by the QAO to ensure that it meets EPA requirements may
20
-------
review and approve internal- and contractor-generated QAPjPs, SAPs and FSPs.
3.6.2 Types of QA Planning Documents
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 QAO 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/QAPrP.
3.6.2.2 Quality Assurance Program Plans
Q A Program Plans (QPPrPs) are formatted and prepared according to EPA Region 9
Guidance for the Preparation of Quality Assurance Program Plans (R9/3.2, June, 2012),
which is based on the requirements in EPA Guidance for QA Project Plans (QA/G-5)
EPA/240/B-01 /003, March 2001. The guidance expands the scope of the QA/G-5
guidance to reflect a programmatic perspective. A QAPrP is appropriate in situations
where an organization using environmental data has multiple on-going and similar
measurement activities, such as collecting monitoring data or performing inspections, or
where a grant recipient serves as an umbrella organization and uses EPA funding to
support its own grants and contracts.
A QAPrP may incorporate elements of a QMP. QAPrPs are expected to cite regulatory
objectives and criteria for decision making. The program should define Hie
documentation requirements for its activities. Either EPA guidance or independently
developed guidance may be specified. QAPrPs should include copies of relevant
sampling or other field standard operating procedures (SOPs), copies of relevant
laboratory Q A Plans/Manuals and/or SOPs or laboratory Statements of Work, and discuss
data reporting and review procedures.
3.6.2.3 Quality Assurance Project Plans
The planning of project-specific data collection activities is documented in QAPjPs or
equivalent documents, such as SAPs (discussed in Section 3.6.2.4). QAPjPs may be
prepared by Region 9 staff or contractors, grantees, responsible parties, or contractors
employed by these organizations. When implemented as written, the QAPjP provides a
detailed record of the scope and objectives of data collection activities, procedures, and
QA/QC requirements. QAPjPs are prepared using one of the several guidance
documents available on the Region 9 Quality Assurance website
21
-------
(www.epa/re gion09/gualit v/documents).
QAPjPs may be used to describe program activities that are limited in scope in lieu of a
QAPrP. QAPjPs should be reviewed by the organization every year, but must be
approved by the Region 9 PO or Remedial Project Manager and QAO every five years,
3.6.2.4 Sampling and Analysis Plans
Sampling and Analysis Plans (SAPs) combine elements of a QAPjP 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) or Sampling and Analysis Guidance and
Template, Version 3, Brownfields Assessment Projects (R9QA/008.1, August 2012) are
available for use on the Region 9 website (www.epa.gov/region9/qa/projplans).
3.6.2.5 Field Sampling Plans
Field Sampling Plans (FSPs) are planning documents for activities taking place within a
longer-term project that has a QAPjP 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 (R9QAJ009.1, May 2014) may be used. The QAO 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 QAPjP. Approval of an FSP is limited to the
specific sampling event
3.6.2.6 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 QAPjP for research projects may also be
appropriate. Questions as to which guidance to use or approach to take should be
directed to the QAO.
3.6.3 Review and Approval of QA Planning Documents
QA planning documents must be approved by the Region 9 QA Manager. Documents
produced by responsible parties (Superftmd), or by grantees (other media programs) are
reviewed by the QAO. In the case of QAPrPs or QAPjPs for the air program, the QAO
approves the document with concurrence from the Air Division Air Quality Analysis
Office. The PO overseeing the grant reviews the planning document for conformance to
program requirements.
22
-------
3.6,4 Quality Assurance Guidance Documents
Guidance for preparing planning documents for all types of projects may be found on the
EPA website (http://www.EPA/home/qualitv). Region 9 has prepared several guidances
to assist organizations in writing QA planning documents, including the QAPrP
guidance, SAP guidance documents and the QAPjP guidance for wetlands projects
(http://www.epa/region9/qa). In addition, a CD ROM containing guidance materials a
template, SOPs and references for surface water monitoring
(http://www,epa.gov/region9/oa/tribes .html) is available. Although the CD ROM was
developed for Tribal programs, it contains information applicable to any surface water
monitoring program. It is available on the Region 1 Q A website
(epa .gov/regionl /lab / qa/qaproj ectplandevtool).
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 QAO; other relevant and ancillary activities are supported by
other Region 9 Divisions and Offices.
4.2 Document Review
4,2.1 Quality Assurance Office Review Process
A primary responsibility of the QAO is document review. Documents may be submitted
to the QAO 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 QAO is completed before a memo relaying
information about the status of a quality assurance document is submitted to the QA
Manager for signature. Occasionally, a PO or Remedial Project Manager with QA
expertise will review a document. The QAO makes the final evaluation regarding the
consistency of the review with Agency and Regional QAO policy. The service standard
for document review is 120 days for QMPs and QAPrPs, and 25 days for QAPjPs, SAPs
and FSPs, although this is subject to negotiation.
During the course of its review, the QAO 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 review
23
-------
memorandum or letter. Reviews may be transmitted independently of the QAO or, in the
case of Tribes and air districts, may be sent by the QAO 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 Super fund 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.
A State or Tribe having a quality system in place that has been described in an EPA-
approved QMP or a QAPrP may receive authorization from EPA to review and approve
its ownQA documents. The QAO 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.
4.3 Training
The QAO provides a variety of trainings designed to meet the needs of specific target
audiences. The training may be generated by the QAO based on an internal assessment
or in response to a program or external request. Trainings may be designed to be
informational or practical.
4.3.1 Quality Assurance Office Staff Competency
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 on-line and in classroom format as time and resources permit.
4.3.1.2 Technical T raining
QAO staff are classified as chemists and environmental scientists with backgrounds that
include specialized training in inorganic chemistry, organic chemistry, hydrogcology,
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 maytaken
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
24
-------
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-Iearnmg (Skillport) database.
4.3.2 In-House and External Training
The QAO 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 QAO responds to all training requests for standard presentations and specific topics.
The QAO also sponsors training from outside sources. Examples of QAO 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
• 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 QAO consist of purchases under $3000
(microprocurement) are made through the Management and Technical Services Division,
Office of the Director. 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 involved several steps. A Program Office first identifies its
25
-------
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 QAPjP is due with the proposal or soon after contract award.
The QAO may review the QA provisions of the Request for Proposal (RFP) or contract.
If a contract includes environmental data collection activities, the QAO participates on
the technical evaluation panel. The QAO also participates in the initial briefing session
with the contractor to provide 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 QAO review. Once the QAO
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
(1GMS). 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 QAO for review and
approval. The QAO reviews the description of the activity being funded and the PO's
responses to specific Q A questions against information in the QAO 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.
26
-------
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 QAO 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 QAO 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 take environmental measurement evaluate and attest the competency
of the laboratories they use or plan to use.
Recipients of EPA grants that include taking environmental measurements: 1) are
required to submit a Quality Assurance Project Plan (QAPP) or a Quality Assurance
Program Plan (QAPrP) for EPA Regional QA Office approval prior to award; and 2)
must submit documentation of laboratory competency for EPA awards
>$200,000. Documentation concerning the laboratory may be submitted with the
QAPrP or QAPjP.
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 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 QAPjP, depending on the nature of the project
27
-------
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 Regional Order
160, Records Management Policies and Procedures, and in the Regional Records
Management Manual. The Manual 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 Management and Technical Services 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.
As Region 9 moves to a smaller footprint within the same building, the QAO is assisting
the RMO to coordinate the Division's activities relating to records management. This
task is expected to continue through the move and will result in a reduction of non-
current work-related documents and references being retained in Division Offices.
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
for at least five years. Superfund documents are then moved to the Super fund Records
Center for long term storage. The QAO keeps a comprehensive file of all signed QA
reviews and some approved plans for reference. Signed reviews are also saved in ,pdf
format as the QAO moves to all electronic record keeping. The original memorandums
are sent to the Tribe or State program (Air) 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 database, developed by the Information Resources Management
Branch (IRMB) Computer Operations Office in collaboration with the QAO, 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
28
-------
database 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 database 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 database 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 on-
going grants and cooperative agreements, the database is consulted to determine the
status of Q A 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 QAO signature, including date, DCN, associated
grantee, Regional and QAO staff.
4.5.2.3 Document Retention
It is Region 9 QAO policy to send approved QA documents to the Project Officer or
grantee who generated them for their records or archives. The QAO requests that
documents be sent electronically to reduce paper and physical storage space use. QAO
will retain some QA documents informally from some programs in order to provide them
to those programs to use as models for other grantees. The QAO has developed, but not
finalized, a records management plan. It will become final when the building renovation
is completed and our common immediate storage space is in place.
4.5.3 Quality Assurance Guidance Documents
Regional Q A 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 QAPrPs
• Wetlands QAPjP Guidance
• QAPjP Preparation Tool for Tribes (with Region 1)
• SAP Guidance and Template
• SAP Guidance and Template for Brownfields Projects
These plans are available on the EPA Region 9 Quality Assurance webpage,
www.epa.gov/region09/qa with the exception of the QA Plan preparation tool for tribes,
which is available in CD-ROM form by request or on line at
(epa.gov/reg 1 /lab/qa/qaproj ectdevtool).
Regional QA guidance documents are drafted by QAO staff experienced in the subject
area and reviewed by the RQAM and other subject-area peers before approval by the
29
-------
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 Information Resources Management Branch in MTSD 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 IRMB 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, IRMB
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. Section
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, IRMB works closely with customers to
determine their needs, options and implementation schedule.
4.6.1.1.2 Development of Software
30
-------
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. A typical example is the Lotus Notes Quality
Assurance Management System (QAMS), a document tracking system developed by
IRMB for the QAO, which is still maintained although the Region has changed internet
platforms to Microsoft 365 (see Section 4,5.2.2). The QAMS database is managed by the
QAO but is available to the Region 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 application; preparation and
delivery of user documentation
• Preparation by the developer of a manual on the development process
• 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 IRMB 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 26
The Geographic Information Systems (GIS) Center is part of IRMB. GIS policy
guidance is found at http://intranet.epa.gov/gis/eeopolicies.html.
The GIS Center follows guidance contained in the following documents;
• OMB Circular A-16. Coordination of Geographic Information, and Related
Spatial Data Activities Chttp ://www.whitehouse. gov/omb/circulars aO 16 rev)
• OMB Circular A-130. Management of Federal Information Resources
fhttp: //www. white ho u se. go v/om b/c i rcul ars a!30 a!30trans4)
31
-------
• Latitude/Longitude Data Standard
(http://www,exchangenetwork.net/standards/Lat Long Standard 08 11 2006 Fi
nal.pdf)
• EPA National Geospatial Data Policy
("http://www.epa.gov/eeosDatial/docs/National Geospatial Data Policy.ndfl
• Global Positioning Systems - Technical Implementation Guidance
(http ;//nepis. epa.gov)
• Guidance for Geospatial Data Quality Assurance Project Plans
(http://www, epa. gov/ geospati al/docs/g 5 g-final.pdf)
• Geospatial Metadata Standards (http://www.fgdc.gov/metadata/geospatial-
metadata- standard s)
• National Geospatial Data Policy Procedures for Geospatial Metadata Management
(http://epa.gov/geospatial/docs/2131 .pdf)
The GIS Center uses the following data and GIS tool:
• EPA Metadata Editor (http s: //e d g. ep a. go v/HM I •/I
• Scribe: Environmental Field Data Capture
Tool (http://www.ertsupport.org/scribe horoe.htm)
4.7 Laboratory Program
4.7.1 Mission
The Region 9 Laboratory is a full-service state-of-the-art facility located in Richmond,
CAs pecializing 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 Richmond Field Station. The Laboratory employs 30-35
scientists, including EPA staff and ESAT contractor staff.
32
-------
4.7.3 Delivery of Laboratory Services
Before samples are analyzed in the Laboratory, a QA planning document is prepared by
the requester, reviewed, and approved by the QAO. The written plan contains the
requester's analytical needs that 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
Q A activities are implemented under the leadership of the Laboratory's Q A Officer. She
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 which 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 QAO performs quality system audits of the
Laboratory in alternate years.
33
-------
4.8 Field Operations
On March 1,2013, EPA issued a memo "... asking all EPA organizations conducting
field activities to implement a sustainable management system that incorporates all 10 of
the Field Operations Group [FOG] guidelines no later than February 15, 2016. " The
ten field guidelines are based on Agency quality-related and ISO-17025 accreditation
requirements. The FOG Guidelines are applicable to all organizations within Region 9
that conduct inspections/investigations and/or collect environmental samples and
measurements in the field. Region 9 is developing its Field Operations Management
System.
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 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.
34
-------
4.8.1.6
Overarching Management System Procedures
The FOG 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.
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.
35
-------
* 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 QAPrPs, QAPjPs, 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 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 QAO
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 Q A Plan and lists the Laboratory SOPs on the Region 9
Laboratory intranet webpage. The QAO 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 QAO 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 request 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. go v/region9/qa/datatables).
36
-------
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 QAO, OPA and IRMB have
developed a Regional policy, the Pre-Dissemination Review, that outlines procedures the
Region follows in 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 (www.epa.gov/si). The RQAM 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
37
-------
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 QAG on Regional programs as needed and as resources allow,
Q AO 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 QAO 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 QAO develops findings
during an audit, presents preliminary findings during the exit briefing and prepares a draft
report, ideally 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 QAO 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.
38
-------
Tafcile 1. Region 9 QA Office 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 MSRs*
Not regularly
scheduled
Audit checklist
Executive
Director
AirPQAOTSA
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
QAPrPs and on
demand
Review of
reported results
Project
Manager/
Superfund, Air
Districts,
DMR-QA
reports
Data
Verification/Validation
As per
recommendation in
QAPrPs
Review of
reported results
Project
Manager
To be added
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 QAO 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
QAO is able to gather current information about quality management systems throughout the Region.
5.2 Assessment Tools
The assessment tools used by the Region are management systems review (MSR).
technical systems audit (TSA), performance evaluation samples (PES) and data
validation.
5.2.1 Management System Reviews (MSRs)
A Management Systems Review (MSR) 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
39
-------
actions.
The QAO may conduct MSRs 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 MSRs 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 MSR 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
QAPrPs, the QAO, working with the state QA Officers, will evaluate the need to develop
a schedule to conduct MSRs of their quality systems.
5.2.2 Technical Systems Audits (TSAs)
A technical systems audit (TS A) 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 TS A 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 considered
to be PQAOs: Morongo, Pechanga, Gila River and Salt River.
Technical System Audits (TSAs) of state air PQAOs are conducted jointly by the Air
Division AQA Office and the QA Office. 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 AQA and QAO perform
equipment audits of other air monitoring programs as requested. TSAs of the Tribes are
conducted by an EPA contractor.
The AQA Office oversees the ESAT technician who conducts compliance audits of
equipment used by air districts for the Air National Performance Audit Program (NPAP)
40
-------
and Performance Evaluation Program (PEP) on a regular basis and as needed. The QAO
continues to provide technical support as requested.
Field audits are conducted by staff at the Region 9 Laboratory; the QAO may participate
or conduct the audit as requested by the Laboratory field team. The QAO conducts field
audits of vapor intrusion investigations for the Superfund Division upon request.
The Laboratory and QAO 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 National Exposure Research Laboratory (NERL), Cincinnati.
Since The NELAC Institute (TNI) became a completely private organization, QAO no
longer participates in Accrediting body evaluations. Staff at the Regional Laboratory
continue to participate in these 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 them, as indicated in the QAPjP.
The QAO 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 QAO
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
41
-------
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 "verificationand. "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 QAO 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, QAO 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 QAO provides technical assistance as
requested.
5.2.4.2 Tiered Data Review
The QAO 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.
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 foil 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
42
-------
Contract Laboratory Program (CLP). Although the guidance is used principally to
validate SuperfLuid data, it may be used in other programs.
6.0 Quality Improvement
The QAO 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.
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 QAO has developed a number of specific templates that are posted on the R9
website. Staff are available to provide further assistance.
6.2 Training
The QAO 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.
6.3 Audits
The Clean Air Act requires EPA to audit air districts within the Region every three years.
The QAO continues to collaborate with the Air Division 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 QAO 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 QAO SOPs will be posted on the Region 9 Quality Assurance webpage.
43
-------
APPENDIX A
-------
Quality Assurance Office
Grade Series
Responsibilities
Years in QA
1320 Chemist
QMPs, QA Program Plans,
small program QA,
training, audits
>20
1320 Chemist
Stiperfund CLP TOP0/
audits, PE program, Air
audits and PEs, Water ATP
coordinator
>20
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
Brownfields review and
training, Water, Regional
Science Counsel co-chair
>20
1301 Environmental
Scientist
Air QA reviews, audits,
Superfund and Air training,
vapor intrusion expert
>15
1301 Environmental
Scientist
Air QA reviews, audits,
Superfund groundwater,
place-based in Hawai'i
>20
1301 Environmental
Scientist
Superfund, Water QA
reviews, training, audits,
statistics, sampling design
>20
1109 Grants Management
Specialist
NEIEN Project Officer,
delegation officer, division
records management liaison
>20
503 Financial Assistant (on
detail)
ESAT assistant COR,
Brownfields QAPP
reviewer
>1
45
-------
APPENDIX B
-------
MANAGEMENT and TECHNICAL SERVICES DIVISION
Management and Technical Services Division
-------
APPENDIX C
£EPA United States Environmental Protection Agency
Region 9
April 2014 ¦
Management snd Tech nic»l Se«ieM Diviiioo
^15.347.8/06
Acting Director; Ca;otyn Iruong
Acting Deputy Director: Brerate
Betteocourt
Adm rt Fe Weber-2-3435
ijBftjBMllffiTecIiiiotejf/ManagefflimJ
• jFunc CostAcccorfing
i-SyeawPatey
.vjQutffcAsiurance
•..fte&Sk francs, Contracts
•vWuasc Resources
OWtl&Sare^acife
Planting
U3i4)Kte Uaftmiint'.A
Air Div«fon
415.947.6715
Director: Deborah Jordan
Deputy Director EEizebetti Adams
Admin: tote* Wilder—7-4143
lAowe
jJ2s®is
UJsfe
iJuiToaes, Radiation & Indoor Air
•JfeQusHy Analysis
<
¦ Pfyi Energy 4 Climate Change
Regional Administrator JarEdBfmnenfetd
Scheduler/Secretary: ftfatGaudario Deputy
Regional Administrator. Alexis Strauss
Administrative Specialist; Nelly Sin|
Special Assistant: TfinaMartynowicz
So. California Field Office;
Director Steven John - 213-244-1804
Land Division
415.947.8704
Director: Jeff Scotl Deputy
Director. Steven pa rfcptc Admin
Agnes Chan—2-3M3
»Pteic I) lends
»USMkxc Bolter
* PesfckfES
* Toxics
* GMdren's Heal)
* EnvironmentBl Education
»Tribal Program
* Resource Conservation &Re«veiy Act
* RCRA&TSCAConediwAcliaii &Permfe
¦ Underground S Sara gs lank fVcgram
* Solid'.Vaste and Municipal LandSIs
> Susl&nabie Materials Management
» Polygon Prewitiw
rrr
H
Office of the
RSflWMl CoBBUl
415.S47.8705
RegionalCcainael; Sylwa Quasi Deoirfv
Regions! Counsel: Robert Moyer Admin:
RwariaBsuaa— 2-3M2
iMm
iJjTOl Counseling
Office of Civil Rights
Director: GinaMwsrtis
Admin; David LOeVere—7-4282
iJfflfflSlS EmptoymenifBamer Ana^sis
^Sc©3il,Effli«iflsis & Dweratji
Awareness
LJasstM Outreach Inialwes
iJEEQ. CarBelinjfMediaticn
Office of Public Affairs
415347.8700
Director: KeRy Zita
Deputy Director Bill Keener
i uJjJOKUl and Congressional ASatrs
! • WebandFOlA
; Islands Contact Office
j (HonoMu, HI)
Enfarccme nt Q rv i tion
41i,W.87CC
Director Kathleen Jolmioi»
Deputy Director: Amy Miller
Arfmin: Mercedes Anaya 7C30
iXoaBaaatfi Inspection
'.JmSSC Development
•.Ate Oversight
VCtoifcKData
Management 8 Analysis
U&,-
LJEoswGswtitai Juslee
Snperfund Drvision
415J47J708
Director: bnnqueiiAOMAiliO.
Deputy Director: Nancy Lindsay
Admin: Christina Cheng —2-3017
jjijtfe Cleanup
¦^lateral F«»ti« end Base Closures
fnerarg Response & Ptammsi
iSmmA involvement
Assessment
tJJ4PDituflor»
iJ3SH®GsS&
: Pfljlnpyiai land, ReviiaUzaton
Cleanup
Water Dwiiion
415.947.8707
Director. Jane Diamond Deputy
Director Krittin Gatlitt Admin:
Unda Moore—2-3745
;_£Ssafl Water Act
l«Ssife Drinking Water Act
jJ&kws Protection, Research &
Sanctuaries Aet
49
-------
REGION IX
QUALITY MANAGEMENT PLAN
U.S. Environmental Protection Agency
Region IX
75 Hawthorne Street
San Francisco CA 94105
Document Control Number
MISC0185PV2
September 2014
------- |