EPARegion 1QMP1
US EPA Region 1 Quality Management Plan

Date: July 21, 2020
Rev.: 1.0
Page 1 of 59

U.S. ENVIRONMENTAL PROTECTION AGENCY

REGION 1
QUALITY MANAGEMENT PLAN

Revision 1.0
July 21, 2020


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EPARegion 1QMP1
US EPA Region 1 Quality Management Plan

Date: July 21, 2020
Rev.: 1.0
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EPA Region 1 Quality Management Plan

NAME: Vaughn Noga

TITLE: Chief Information Officer & Deputy Assistant Administrator for
Environmental Information, Office of Mission Support, U.S. EPA

APPROVAL FOR AGENCY

VAUGHN
NOGA

Digitally signed by
VAUGHN NOGA

Date: 2020.07.30
15:02:38 -04'00'


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EPARegion 1QMP1
US EPA Region 1 Quality Management Plan

Date: July 21, 2020
Rev.: 1.0
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EPA Region 1 Quality Management Plan
APPROVAL FOR EPA REGION 1

1.

DENNIS
DEZIEL

Digitally signed by
DENNIS DlZIEL
2020.07.29
13:15:43 -04'00'

NAME: Dennis Deziel

TITLE: Regional Administrator, Office of Regional Administrator

CONCURRENCE

1.

l/ADCM	Digitally signed by

^ ^—	KAREN MCGUIRE

IV/l^f^l IIPP	Date: 2020.07.27

IVIOOUIrxC	09:03:03 -04'00'

NAME: Karen McGuire

TITLE: Director, Enforcement and Compliance Assurance Division

2.

A DTI—II ID Digitally signed by
/-\r\ I r1Ur\ ARTHUR JOHNSON

JOHNSON gfl/^Q27

NAME: Arthur Johnson

TITLE: Director, Mission Support Division

3.

Digitally signed by ROBERT
REINHART

Date: 2020.07.21 14:54:21 -04'00'

ROBERT
REINHART

NAME: Robert Reinhart

TITLE: Regional Quality Assurance Manager

4.

I OH A MM A	Digitally signed by

JVJnAINlNA	JOHANNA HUNTER

Ul IMTCD	Date: 2020.07.21

NUN I tr\	15:03:46-04'00'

NAME: Johanna Hunter

TITLE: Director, Laboratory Services and Applied Science Division


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5.

I YMMF	Digitally signed by

l_ I IN IN t	LYNNEHAMJIAN

HAM J IAN

EPARegion 1QMP1
US EPA Region 1 Quality Management Plan

Date: July 21, 2020
Rev.: 1.0
Page 4 of 59

NAME: Lynne Hamjian

TITLE: Director, Air and Radiation Division

6.

KFNNFTH	Digitally signed by

r\l_ININI_ I I I	KENNETH MORAFF

MHDACC	Date: 2020.07.27

IVIUr\Mrr	10:44:20 -o4,ooi

NAME: Ken Moraff

TITLE: Director, Water Division

7.

RRYAM	Digitally signed by

DIA I AAIN	BRYAN OLSON

Q/^KI	Date: 2020.07.27

WLOWlN	11:16:05 -04'00'

NAME: Bryan Olson,

TITLE: Director, Superfund and Emergency Management Division

8 NANCY

Digitally signed by
NANCY BARMAKIAN

BARMAKIAN

NAME: Nancy Barmakian

TITLE: Director, Land, Chemicals and Redevelopment Division

9.

CARL

Digitally signed by
CARL DIERKER

Date: 2020.07.27

12:56:18 -04'00'

NAME: Carl Dierker

TITLE: Regional Counsel, Office of Regional Counsel


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EPARegion 1QMP1
US EPA Region 1 Quality Management Plan

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Rev.: 1.0
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Table of Contents

Introduction	7

1.0 Management and Organization	7

1.1	EPA Region 1 Mission Statement	8

1.2	EPA Region 1 Quality Assurance Policy	8

1.3	Assignment of Responsibility	8

1.4	Environmental Program and Operations	15

2.0 Quality System Components	25

3.0 Personnel Qualifications, Training and Competence	28

3.1	Commitment to Training	29

3.2	Qualifications	29

3.3	Professional Development and Training	29

3.4	Certifications	30

3.5	Regional QA Training	30

4.0 Procurement of Items and Services	32

4.1	Contracts	32

4.2	Financial Assistance Agreements	33

5.0 Documents and Records	34

5.1	Records and Documents Pertaining to the Quality Management Plan	35

5.2	Ensuring Documents and Records Accurately Reflect Completed Work	37

5.3	Establishing and Implementing Chain of Custody and Confidentiality Procedures37

5.4	Regulations, Policies, and Guidance Pertaining to Documents and Records	38

6.0 C omputer Hardware and Software	38

6.1	Roles and Responsibilities	39

6.2	Regional Information Management Systems	39

6.3	Hardware and Software Requirements	40

6.4	Data Standards	40

6.5	EPA Region 1 Internet and Intranet Site Responsibilities and Procedures	40

7.0 Planning	41

7.1	Region 1 QAB Planning Procedures	41

7.2	Quality Management Plans (QMPs)	42

7.3	Quality Assurance Project Plans (QAPPs)	42

7.4	QAPP Approval Authority	44


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8.0 Implementation of Work Processes	45

8.1	Regional Procedures	45

8.2	Standard Operating Procedures (SOPs)	45

8.3	Responsibility for Regional Procedures and SOPs	46

8.4	LSASD SOPs	46

8.5	Inspection and Oversight of Work-Related Processes	47

8.6	Tracking and Reporting QAB Activities	47

9.0 Assessment and Response	47

9.1	Region 1 Quality System Assessment	47

9.2	Internal Assessments	50

9.3	External Assessments Performed	52

9.4	Internal and External Assessment Reporting and Response	52

9.5	Corrective Actions	53

9.6	Di spute Resoluti on	53

10.0 Quality Improvement	53

10.1	EPA Lean Management System (ELMS)	54

10.2	Roles and Responsibilities	54

10.3	Annual Reporting	55

10.4	Organizational Improvement Based on Assessments	55

Attachement 1 - Acronyms	56

List of Appendicies	59


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EPARegion 1QMP1
US EPA Region 1 Quality Management Plan

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Rev.: 1.0
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INTRODUCTION

The mission of the U.S. Environmental Protection Agency is to protect human health and the
environment - air, water, and land - upon which life depends. EPA Region 1 focuses on human
health and environmental issues within the six New England States for present and future
generations.

The EPA Region 1 mission framework is documented in the EPA Region 1 Quality Management
Plan (QMP) which defines the Quality System (QS). The QMP describes the policies,
procedures, and management systems within the organization that govern quality assurance (QA)
and quality control (QC) practices applied to environmental programs involving environmental
information and technology1. The QS was developed in accordance with the EPA Order CIO
2105.0. EPA's policy it to ensure that all environmental programs performed by EPA, or directly
for EPA through EPA-funded extramural agreements, shall be supported by individual quality
systems that comply with the American National Standard ASQ/ANSI E4:2014, Quality
management systems for environmental information and technology programs - Requirements
with guidance for use, prepared as an American National Standard by: ASQ Energy and
Environmental Division and ASQ Standards Committee.

The QMP also incorporates, by reference, the QA allied Regional policies and/or programs
including the: Peer Review Policy; Information Quality Guidelines-Pre-dissemination Review2:
Policies for Assuring Competency, Scientific Integrity Policy, Human Subject Research Policy
and the Quality Assurance Field Activities Procedure (OAFAP).

1.0 MANAGEMENT AND ORGANIZATION

This Section documents the Regional quality system overall policy, scope, applicability, and
management responsibilities. The EPA Region 1 Administrator, Deputy Regional Administrator,
and senior management are fully committed to implementing an effective quality system. Senior
management ensures understanding and implementation of the Regional quality system by
issuing policy statements, allocating resources, performing assessments, developing guidance
and providing training. Regional commitment is consistent with the objectives and goals EPA
Order CIO 2105.0.

1	ASQ/ANSI E4:2014, environmental information - any data, measurements, or calculations that describe
environmental processes, location, or conditions; ecological or health effects and consequences; or the performance
of environmental technology.

Note 1 - Environmental information includes data collected directly from measurements, produced from models,
and compiled from other sources such as data bases or the literature.

Note 2 - Environmental information also includes data derived from samples collected from the environment, the
results of other analytical testing (e.g., geophysical, hydrological) of environmental conditions, and process data of
physical parameters collected from the operation of environmental technologies.

2	Please note that not all hyperlinks are available to all users. If you need access to a site that you are restricted from
please contact the RQAM.


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Rev.: 1.0
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1.1	EPA Region 1 Mission Statement

The mission of the U.S. Environmental Protection Agency is to protect human health and the
environment — air, water, and land — upon which life depends. The EPA New England Regional
Office focuses on human health and environmental issues within the six New England States for
present and future generations. Additional information about the Region is available on the EPA
Region 1 website.

1.2	EPA Region 1 Quality Assurance Policy

It is Regional policies and procedures which ensure that environmental data operations will
result in the collection, production, and use of environmental data of known and documented
quality, suitable for the intended use. This quality policy applies to all environmental information
and technology activities performed by and for the Region. To that end, quality assurance (QA)
and quality control (QC) requirements, processes, and procedures are integrated into the Region's
media programs that administer environmental information and technology operations directly
and through grants, cooperative agreements, interagency agreements and contracts.

The Regional Administrator and senior management ensure that adequate resources, including;
intramural, extramural, training and travel funds, and personnel are available and allocated to
achieve the Region's quality mission. All Region 1 employees have a responsibility to
implement the quality system elements, as appropriate, to ensure the quality of decisions made.

1.3	Assignment of Responsibility

In accordance with EPA Order CIO 2105.0, the Regional Administrator has overall
responsibility for the QA program. Through the approved QMP, the Regional Administrator has
delegated authority to the Regional Quality Assurance Manager (RQAM) for: developing and
documenting Regional QA policies, procedures and guidance; overseeing the implementation
and assessment of the Regional quality system; and providing QA training. The RQAM is
located within the Laboratory Services and Applied Science Division (LSASD).

Figure 1 depicts the basic components of the Region's organization and structure for quality
assurance authority and reporting. The RQAM reports directly to the LSASD Division Director.
The dashed line between the RQAM and the Deputy Regional Administrator indicates that the
RQAM can elevate issues to the next higher level of senior management, that is, the Deputy
Regional Administrator. Further detail can be found in the Region 1 organizational charts.


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Figure 1 Quality Assurance Reporting and Structure

Roles and responsibilities pertaining to the implementation of allied programs including Peer
Review, Information Quality Guidelines, Pre-dissemination Review, and Human Subject
Research are detailed in their respective implementation plans. Intranet and Internet links are
provided for these program plans in Section 2.

Specific quality assurance responsibilities for Regional personnel and partners are described
below:

1.3.1 Regional & Deputy Regional Administrator, Division Directors/Deputy
Directors, and Branch/Section Chiefs

As specified in EPA Order CIO 2105.0 the Regional Administrator (RA) and Deputy Regional
Administrator (DRA), Division Directors (DD), Deputy Division Directors (DDD), Branch
Chiefs, and Section Chiefs are responsible for the Regional quality system, and to that end they:

• Designate one representative from each division and/or branch for quality management
activities, to advise and assist the implementation of the Quality System (QS) through
planning, documentation, implementation, assessment, and quality improvement within
their purview (see 1.3.6);

• Ensure that all Regional components and programs comply fully with the EPA Order
CIO 2105.0, including the preparation of the Region 1 QMP, implementation of an


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effective Regional quality system (QS), and effective communication and support to the
HQs, Office of Mission Support (OMS);

•	Ensure that quality management activities are identified, and resources are adequate to
support the Quality System (QS) components, and that the QS is implemented as
prescribed in this QMP;

•	Ensure that all environmental programs implemented through extramural agreements are
compliant with the EPA Order CIO 2105.0;

•	Ensure that the environmental data from environmental programs delegated to State,
local, and Tribal governments meet program data quality objectives, including sufficient
quantity and adequate quality for their intended use;

•	Ensure that training is available for State, local, and Tribal governments performing
environmental programs for EPA. Training specific to the fundamental concepts and
practices of quality management, and QA/QC activities which ensure the quality of
outcomes or products;

•	Ensure that assessments of Regional environmental programs, internal and external
programs, are performed at a frequency appropriate to the program, and that assessments
are performed against approved QMPs to determine the effective implementation of the
Quality System;

•	Ensure that deficiencies identified through assessments are addressed appropriately;

•	Identify QA and QC training needs for all levels of management and staff and support the
training; and

•	Ensure that performance plans for all Region 1 personnel are commensurate with the
quality management responsibilities designated by this QMP.

1.3.2 Regional Quality Assurance Manager (RQAM)

The Regional Administrator has delegated the responsibility and authority to implement the
Regional quality system to the RQAM. As shown in Figure 1, the Regional QA Manager
position is located within the Laboratory Services and Applied Science Division (LSASD). The
dashed line connection to the Deputy Regional Administrator (DRA), indicates that the QA
Manager can directly and independently interact and communicate with the DRA. This signifies
independence in all QA matters. The RQAM can independently elevate quality-related issues to
the DRA at his/her discretion without challenge. The RQAM does not need approval or pre-
notification to initiate such communication.

The RQAM manages the QAB located organizationally within LSASD. The RQAM utilizes the
QAB staff to assist in the day-to-day implementation of the Regional quality system. QA staff
has access to appropriate levels of management to address all QA matters. The QAB will use
commonly accepted practices, such as starting with the lowest possible level of management,
escalating to higher levels of management, only as necessary to resolve conflicts. The QA staff is


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expected to notify the RQAM whenever any level of management involvement is needed to
resolve QA issues. Should the RQAM recognize that QA independence is being challenged; the
RQAM can initiate communication with the DRA as described above. RQAM responsibilities
include:

•	Facilitating the EPA Region 1 QMP development, approval, and maintenance;

•	Collaborating with EQMD OMS, EPA programs and partners regarding the
implementation of EPA Order CIO 2105.0;

•	Providing expert assistance to staff in the organization regarding QA/QC policies,
requirements, and procedures applicable to procurement and technical activities;

•	Ensuring the implementation of Quality System (QS) policies and procedures, and tools
for EPA Region 1;

•	Identifying and providing or making provisions for QS, QA, and/or QC training needs for
the organization,

•	Collaborate with the Mission Support Division (MSD) to ensure the implementation of
QS financial agreements and contract QS requirements.

1.3.3 Managers

As primary supervisors of Regional personnel, managers have the ability to directly evaluate the
effectiveness of the planning, implementation, and assessment components of the Region's
quality system. Managers are responsible for:

•	Ensuring that quality management is an identified activity with associated resources
adequate to accomplish program quality goals;

•	Ensuring that all organizational components and programs for which management is
responsible comply fully with the requirements of the EPA Order CIO 2105.0;

•	Ensuring that all sampling, analytical and data handling practices are documented in
written procedures, i.e., SOPs. SOPs for all Branch programs are developed as functional,
accurate documents that are approved initially and reviewed routinely for continued
adequacy;

•	Assessing the QA/QC training needs of their staff and arranging for such training with
the RQAM;

•	Requiring staff to use current guidance and requirement documents from both OMS and
the Regional QAB to ensure uniform application of Agency QA policies and procedures;

•	Ensuring that a systematic planning process is used to determine project quality
objectives for all environmental data operations; and subsequently, ensuring that the
results of the planning process are sufficiently documented in approved QA planning
documents, i.e., QAPPs and SAPs, prior to the initiation of work;

•	Ensuring that QAPPs are implemented as described; that technical assessments are


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performed as required; and that data are reviewed prior to use;

•	Ensuring that corrective actions are monitored for implementation and effectiveness; and

•	Implementing program recording-keeping procedures to ensure the maintenance of
quality-related documents including QMPs, QAPPs, amendments, technical assessments,
corrective action responses, and data review and usability reports.

1.3.4 Contracting Officer's Representatives, Project Officers and Project
Managers

EPA personnel involved with environmental information operations performed under financial
assistance agreements, contracts, and extramural, non-supported measurement (as by industry)
are responsible for incorporating QA requirements into grants, cooperative agreements,
interagency agreements, contracts, and voluntary, consensual or unilateral enforcement
agreements, decrees and orders.

Project Officers, including Grant and Interagency Agreement; Contracting Officer
Representatives, and Project Managers (Remedial Project Managers (RPMs), Site Assessment
Mangers (SAMs), RCRA Facility Managers (RFMs), and On-Scene Coordinators (OSCs)) are
responsible for:

•	Ensuring EPA Order CIO 2105.0 and Regional requirements are satisfied in all
environmental projects conducted by EPA personnel or through grants, cooperative
agreements, interagency agreements and contracts;

•	Ensuring QA requirements are incorporated or negotiated into voluntary, consensual or
unilateral enforcement agreements, decrees and orders;

•	Ensuring that all QA deliverables (QMPs or equivalent quality system documentation,
QA Management Reports, QAPPs/SAPs, amendments, addenda, SOPs, QC performance
results, data quality reports, etc.) are provided to the Region;

•	Providing signature concurrence or approval on QAPPs;

•	Ensuring that QAPPs are approved prior to the initiation of data collection and
implemented as written for all projects involving environmental data operations;

•	Ensuring that appropriate QA documentation, including copies of signed and completed
QA Project Plan Approval Forms, QAPP/SAP Title and Approval Pages and/or copies of
the final approval letters or documentation, are provided to the QAB prior to the initiation
of environmental data operations for programs that have been delegated QAPP approval
authority;

•	Ensuring that QA Review Forms (QARFs) are completed and provided to the RQAM
when required for contracts, work assignments, delivery orders and task orders;


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•	Ensuring that QAPPs are implemented as described; that technical assessments are
performed as necessary; corrective actions are implemented when required; and that data
are reviewed prior to use;

•	Assuring that the results of environmental programs are of sufficient quantity and
adequate quality for their intended use; and

•	Conforming to program record-keeping procedures and QA-related documents.

1.3.4.1	Contract Officers, Contracting Officer's Representatives (CORs)

Regional Contract Officers and Contracting Officer's Representatives (CORs) preparing
acquisition packages, awarding, and overseeing Agency funded contracts and procurements
supporting environmental information and technologies are responsible for ensuring that
contracts and associated documents include current QA requirements from National and
Regional policies and programs.

The Region's procurement process ensures compliance with and full participation by all
Regional programs with applicable policies and regulations pertaining to QA in the procurement
and management of contracts, work assignments, delivery orders and task orders. Contracting
Officers and authorized CORs are responsible for adhering to the EPA Acquisition Guide,
Chapter 46 Quality Assurance, Section 46.2 Contract Quality Requirements and the most current
version of the Contract and Procurement OA Requirements Statements.

•	Quality Assurance Review Forms (QARF) for SEMD Contracts and Procurements

•	Quality Assurance Review Forms (QARF) for Non-SEMD Contracts and Procurements

1.3.4.2	Project Officers/Project Managers for Grants, Cooperative Agreements,
Interagency Agreements and Grant Specialists

EPA staff including Project Officers and Grant Specialists that award and oversee Regionally
funded grants, cooperative agreements and interagency agreements are responsible for ensuring
that financial assistance agreements include current National and Regional QA policies and
procedures. The Region's grants management process was established to ensure compliance with
and participation by all Regional programs with applicable QA policies and regulations
pertaining to the award and management of grants, cooperative and interagency agreements.

Project Officers for Grants and Cooperative Agreements and Grant Specialists are responsible
for the procedures in the most current version of the Region 1 OA Policy Memo for Grants. See
Appendices.

Similarly, Interagency Agreement (IA) Project Officers are responsible for the procedures in the
most current version of the Region 1 OA Policy Memo for IAs. See Appendices.

1.3.5 Office QA Contacts

Senior management is committed to providing resources to ensure compliance with QA
requirements in the award and management of financial assistance agreements. In each


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Division/Office an individual has been identified as a QA Contact. The office QA contacts assist
staff in complying with QA policies and procedures specific to the Division/Office functions.
QA Division/Office contacts responsibilities are described in the memos referenced above.

1.3.6	LSASD Laboratory Quality Assurance Officer (QAO)

The LSASD Laboratory QAO, is a member of the QAB, and is responsible for implementing the
laboratory quality system as described in the Quality Manual for US EPA New England Regional
Laboratory (NERL), Laboratory Services and Applied Science Division (hereafter the NERL
Quality Manual). The QAO reports to the RQAM and keeps the LSASD Management team
apprised on the status of the lab qualtiy system. The QAO works together with QAB staff to
conduct audits and other necessary checks on the quality system.

1.3.7	Field Sampling/Measurements, Existing Data, and Environmental
Modeling

1.3.7.1	Field Sampling and Field Measurements

For EPA personnel performing field sampling and/or collecting field measurements, QA
activities include:

•	Ensuring that the procedures comply with CIO 2105-P-02.0, EPA QA Field Activities
Procedure (EPA QAFAP), which include QA documents; QAPPs, SAPs, FSPs, SOPs,
etc.;

•	Documenting any deviations from established methodologies, SOPs and QC protocols, in
the report or final documents as appropriate, and communicating the deviations to the
project team, including the data users;

•	Identifying possible data quality problems and potential areas for quality improvement
and reporting these to the project team, including the data users in a timely manner;

1.3.7.2	Regional Staff Acquiring, Using, and Compiling Existing Data

EPA personnel acquiring, using, and compiling existing data are responsible for:

•	Ensuring that existing data activities are performed according to an approved QAPP or
equivalent document. Specifically, data selection and rejection criteria must be
documented in the QAPP and all data sources of existing data must be documented;

•	Documenting any deviations from established methodologies, SOPs and QC protocols,
and reporting the deviations to their project team and data users as appropriate;

1.3.7.3	Regional Staff and Environmental Models

EPA personnel developing, evaluating, and applying environmental models are responsible for:

•	Ensuring that work is conducted under approved QA planning documents and is
consistent with the most EPA Order CIO 2105.0. Data selection and rejection criteria
must be documented in the planning document and necessary training for the subject
model must be procured prior to generating data;


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•	Following established appropriate and applicable modeling practices/procedures as
described in QA planning documents;

•	Reviewing modeling reports, documenting any deviations from approved QAPPs and
reporting deviations to the project team and end users;

•	Identifying possible data quality problems and potential areas for quality improvements
and reporting them to the project team and end users;

•	Ensuring that the model performs as anticipated and meets the objectives and
documenting the procedures for the mechanism of assurance.

1.3.8 Dispute Resolution

When quality assurance issues are disputed, resolution will be sought at the lowest management
level possible. Such disputes may occur in situations involving technical issues (e.g., audits, data
quality assessments) and management issues (e.g., QMP reviews, QAPP reviews, and quality
system assessments).

All parties will make every effort to resolve disputes through discussion and negotiation.
Disagreements will be resolved at the lowest administrative level possible. The Region has
trained mediators on staff to help facilitate dispute resolution. Should agreement not be reached
at a lower level of management, the issue will be resolved by senior management. The Regional
Administrator and the Deputy Regional Administrator have final dispute authority for all quality
issues.

1.4 Environmental Program and Operations
1.4.1 Office of Regional Administrator

The Office of the Regional Administrator (ORA) is the central coordinating Office of the Region
providing leadership, planning, and oversight of key policy and program initiatives and resource
management. While the Regional Administrator is ultimately responsible for the Regional
quality system, few environmental data operations are conducted directly by this Office.
However, when ORA does perform an environmental data operation (e.g., education grants,
environmental impact reviews), all Regional quality policies and procedures are applied.

The Agency has appointed a Scientific Integrity Official to champion scientific integrity
throughout the Agency. The Scientific Integrity Official chairs a standing committee of Deputy
Scientific Integrity Officials representing each EPA Program Office and Region. The EPA
Region 1 Scientific Integrity Official is a senior-level employee who provides oversight for the
implementation of the Scientific Integrity Policy, acting as liaison for the Region and is available
to address any questions or concerns regarding this policy. The Regional Administrator has
designated the Director of the Laboratory Services and Applied Science Division (LSASD) as
the Regional Scientific Integrity Official.


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1.4.2 Laboratory Services and Applied Science Division

The Laboratory Services and Applied Science Division (LSASD) is organized into the following
Branches:

•	Quality Assurance Branch

•	Field Services Branch

•	Lab Services Branch

LSASD administers the following programs:

•	Quality management

•	Scientific integrity

•	Field sampling

•	Lab services

In accordance with the Agency Policy Directive Ensuring the Competency of EPA Laboratories,
the FSB and LSB have documented their quality system in the NERL Quality Manual which is
maintained in the LSASD Document Control System. It describes specific quality system
components and demonstrates laboratory competency through the use of independent external
assessments and participation in inter-laboratory comparison studies and programs. The
Directive requires that all EPA laboratories become accredited where appropriate. To this end,
NERL maintains ISO 17025 certification for biology, chemistry and field sampling parameters.
ISO certification is maintained through adherence to ISO requirements.

1.4.2.1 Quality Assurance Branch

The QAB is responsible for managing the Regional quality system; establishing quality policy,
guidance, and procedures for all environmental data operations as appropriate; reviewing and
approving intramural and extramural QMPs and QAPPs; and reviewing various QA documents
(e.g., SAPs, workplans, SOPs); conducting Quality System Assessments (QSAs) and Technical
Assessments/Audits to ensure conformance with QA requirements; providing guidance for
developing project quality objectives, QMPs, QAPPs, SOPs; and providing technical assistance
to resolve sampling, analytical, and data usability issues. Members of the QAB also provide
training for QA/QC concepts and QA requirements, for the program offices within the Region,
Agency contractors, and State, Tribal, and local governments that are involved in environmental
data operations.

In addition, the Branch is responsible for coordinating the Regional Peer Review Program;
providing analytical services through the Contract Laboratory Program (CLP), providing various
support through the Environmental Services Assistance Team (ESAT) contract; coordinating the
Information Quality Guidelines-Pre-dissemination Review program; supporting the FASTAC
strategy; providing quality assurance assistance to the Superfund Program by administering the
Performance Evaluation Sample Program; managing the Drinking Water Certification Program;
performing Alternate Test Method reviews; and supporting the National Environmental


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Laboratory Accreditation Program (NELAP).
1.4.2.2 Lab Services Branch

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The Lab Services Branch (LSB) is responsible for performing chemical and biological analyses
of environmental samples, and providing oversight of ESAT, and external contract laboratories
to support investigations conducted by the EPA Region 1. The Team also provides technical
assistance to the Regional media programs, State and local environmental agencies, private
industries and independent laboratories in areas such as analytical methods and method
development. Members of the Team provide consultation for legal cases and supporting various
laboratory audits.

1.4.2.3 Field Services Branch

The Field Services Branch (FSB) supports Regional programs, States and Tribes, as well as
nationwide monitoring initiatives. Under the Clean Water Act and Clean Air Act, FSB assists
States and Tribes implementing and ensuring compliance with ambient monitoring programs.

FSB works with the States to implement National and State ambient air monitoring programs,
including special projects and research on priority issues such as mercury. FSB oversees the
collection and evaluation of air quality data collected by States and other entities in support of
Regional and National monitoring. FSB has delegated QAPP approval authority and is
responsible for reviewing all external air programs' QAPPs for environmental data collection
and for approving external air program standard operating procedures (SOPs). FSB ensures that
air monitoring meets the Agency's required siting and design criteria, data collection techniques,
and QA/QC procedures. It ensures that data are accurately reported to the Agency's National
data system, AQS, or another appropriate data system.

The FSB is also responsible for providing field support, including environmental sampling and
regulatory compliance inspections for the Air, Water and Waste Programs. These activities are
performed to determine compliance with the applicable provisions of the CAA, RCRA, SDWA,
CWA, and TSCA. Environmental sampling is conducted according to generic and project
specific QAPPs, sampling and field measurement SOPs, and data are reviewed prior to decision
making.

Data are collected by FSB according to a generic program QAPP (with associated sampling and
analysis plans (SAPs), project specific QAPPs, and sampling and field measurement SOPs. Data
are reviewed prior to use in identifying and characterizing sources of contamination, determining
compliance with State water quality standards, developing mathematical models for load
allocations, and reporting on the general health of New England's waters.

1.4.3 Superfund and Emergency Management Division

The Superfund and Emergency Management Division (SEMD) is an integrated office for the
management of hazardous waste sites and emergency response activities. SEMD is organized
into the following branches:

• Emergency Planning and Response Branch


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•	Remediation Branch I

•	Remediation Branch II

SEMD Administers the following programs:

•	Superfund site assessment and cleanup

•	Emergency response

•	Oil spill prevention and planning

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1.4.3.1	Remediation and Restoration Programs

At Fund-lead NPL sites, SEMD, States and their contractors undertake environmental data
operations to characterize sites, make site remediation decisions, and monitor remedy
implementation and effectiveness. At PRP-lead and Federal Facility NPL sites, Lead agencies
and their contractors undertake environmental data operations to characterize sites, develop site
remediation alternatives, and monitor remedy implementation and effectiveness. SEMD and the
States oversee activities undertaken at PRP and Federal Facilities sites.

Associated environmental data operations are conducted in accordance with National and
Regional quality standards and guidance, and data are reviewed prior to use.

1.4.3.2	Superfund Emergency Planning and Response

During an emergency response including incidents of National significance, SEMD, States and
their contractors may undertake environmental data operations to characterize the spill or release,
assess the risk to the surrounding population, and determine the appropriate response to contain
or minimize the spread of the spill or release. Data collection operations performed by the
Emergency Planning and Response Branch (EPRB) are conducted under the EPRB Generic
Program Quality Assurance Plan developed in accordance with National and Regional quality
standards and guidance, and data are reviewed prior to use.

1.4.4 Land, Chemicals, and Redevelopment Division

The Land, Chemicals, and Redevelopment Division (LCRD) is organized into the following
sections:

•	Brownfields and Sustainable Materials Management Section

•	RCRA Waste Management, UST and Pesticides Section

•	RCRA Corrective Action and TSCA Section

LCRD administers the following programs:

•	RCRA Hazardous waste management

•	RCRA facility corrective action

•	Underground storage tanks/Leaking underground storage tanks


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•	Brownfields

•	Toxic Substances Control Act (TSCA)

o PCB program and
o Lead-based paint program

•	Asbestos demolition/renovation

•	Pesticides

•	Pollution prevention
1.4.4.1 LCRD Programs

The Resource Conservation and Recovery Act (RCRA) program is overseen and monitored by
LCRD and enforced by ECAD. All six New England States have been authorized to implement
RCRA requirements and EPA maintains oversight responsibility.

The UST/LUST programs have been delegated to all six New England States. LCRD maintains
oversight responsibility for the delegated programs in all six New England States.

1.4.5 Water Division

WD is a multi-program, ecosystem-based office that works to establish environmental standards
and goals and works with States and communities to achieve these goals. The WD manages
regulatory considerations and issues permits.

Programs involved in the collection, production and use of environmental data, including the
application or development of models, are described below.

The Water Division is organized into the following Branches and Sections:

•	Drinking Water and Municipal Assistance Branch

•	Surface Water Protection Branch

•	Water Permits Branch

The Water Division administers the following programs:

•	Coastal and ocean resources

•	Drinking water

•	Groundwater protection

•	Water infrastructure

•	National Estuary Program

•	Lake Champlain Basin Program


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•	S outheast New Engl and Program

•	Non-point source pollution

•	NPDES permits

•	Ocean disposal and dredging

•	Clean Water State Revolving Fund (CWSRF)

•	Drinking Water State Revolving Fund (DWSRF)

•	Water quality standards

•	Total Maximum Daily Loads (TMDLs)

•	Wastewater and storm water permitting

•	Watershed restoration

•	Wetlands

1.4.5.1 Water Programs

The WD has permitting and monitoring responsibilities for the wide range of programs and
regulations relating to the Region's water systems, from drinking water to wastewater. EC AD
supports these activities with field inspection and compliance activities as well as enforcement
actions. The major data collection activities are divided into different areas pursuant to
supporting the Clean Water Act, the Marine Protection, Research and Sanctuaries Act, and the
Safe Drinking Water Act.

WD staff members in conjunction with LSASD are responsible for reviewing and approving
QAPPs prepared by grantees and contractors working with or gathering environmental data.

1.4.5.1.1	Clean Water Act

The WD's water program branches (Surface Water Branch, Water Permits Branch, Drinking
Water and Municipal Assistance Branch) are responsible for implementing and monitoring
programs which support all aspects of the Clean Water Act (CWA) and Safe Drinking Water Act
(SDWA).

WD staff members in the Water Permits Branch implement the National Pollutant Discharge
Elimination System (NPDES) permit program either directly or through oversight of a delegated
State. For the NPDES and Pretreatment programs, primacy has been delegated to four New
England States: Connecticut, Rhode Island, Maine and Vermont.

1.4.5.1.2	Safe Drinking Water Act

All six New England States have been delegated or authorized to enforce the following SDWA
programs; PWSS Drinking Water, Wellhead Protection and UlC/Section 1422. The Drinking
Water Quality Protection Unit oversees state enforcement of the SDWA through the Safe
Drinking Water Information System (SDWIS), which contains information about public water
systems and their violations.


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1.4.6	Enforcement and Compliance Assurance Division

The Enforcement and Compliance Assurance Division (ECAD) is responsible for developing
and implementing Regions l's enforcement and compliance assurance programs and statutes that
EPA administers in the geographic boundaries of the region. ECAD is organized into the
following Sections:

•	Water Compliance Section

•	Air Compliance Section

•	Waste and Chemical Compliance Section

•	Toxics, Pesticides and Drinking Water Compliance Section

•	Multi-Media Assistance and Support Section

ECAD administers the following programs:

•	Enforcement of broad range of environmental statutes, including the Clean Air Act
(CAA), Clean Water Act (CWA), Safe Drinking Water Act (SDWA), Resource Conservation
and Recovery Act (RCRA), Federal Insecticide, Fungicide and Rodenticide Act (FIFRA),
Toxics Substance Control Act (TSCA), Emergency Planning and Right- To- Know Act
(EPCRA), Marine protection, Research, and Sanctuaries Act (MPRSA

•	Inspections and compliance monitoring programs, including targeting, on- and off-site
compliance monitoring activities, credentialing, and inspection reports Developing
enforcement cases, preparing and issuing administrative actions, assessing penalties,
developing judicial enforcement actions, and negotiating Tracking and resolution of tips
and complaints

•	Implementing compliance assistance activities

1.4.7	Mission Support Division

The Mission Support Division is a resource management office responsible for personnel,
facilities, and space; financial management, including budgeting; information services; grants,
contracts, and procurement; and other support services. No significant environmental data
operations are performed directly by this office. Its role in supporting environmental programs is
discussed below.

MSD is organized into the following Branches and Sections:

•	Information Services Branch

•	Customer Service and Facilities Branch

•	Comptroller Branch

•	Human Resources Branch

•	Contracts and Procurement Branch


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•	Grants Management Branch

MSD administers the following programs:

•	Strategic planning and process improvement

•	Budget

•	Finance

•	Financial aspects of cost recovery

•	Management Control and Financial Integrity Federal Managers Financial Integrity Act
(FMFIA)

•	Facilities and security

•	Health and safety

•	Human resources

•	Information technology and information management (including geographic information
systems)

•	Customer service support

•	Management of grants and interagency agreements

•	Contracts and acquisitions

The Contracts and Procurement Branch is responsible for ensuring all contracts and
procurements incorporate QA requirements in accordance with 48 CFR Part 46, and Regional
QA requirements for contracts, typically represented by QARF, and procurements.

The Grants Management Branch is responsible for ensuring that all statutory and regulatory
administrative requirements are addressed prior to the award of all financial assistance
agreements. This includes QA requirements specified in 40 CFR Parts 30, 31 and 35 and
Regional requirements for implementing QA policies for financial assistance agreements.

The Information Services Branch is responsible for the storage, management, and retrieval of
mainframe data for PCS, STORET and the AIRS database systems. This Office is also
responsible for the Region's IT infrastructure, the purchase and upkeep of computer hardware
and software and technical support for the Region's Geographic Information Systems (GIS),
providing Web, desktop computing, IT security and local applications development support.
Additional information on these functions can be found in Section 6.0 of this QMP.


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1.4.8 Air and Radiation Division

The Air and Radiation Division (ARD) implements the programmatic aspects of the Clean Air
Act (CAA) within the geographic boundaries of Region 1, except for inspections and
enforcement, which are principally managed by the ECAD. Additionally, LSASD principally
implements regional and federal regulations and guideline associated with the collection of air
quality data. Under the CAA and in accordance with implementing regulations and agency
guidelines, the Division conducts activities to reduce emissions so that air pollution does not
constitute a threat to public health, safety, well-being and the environment. To carry out its
mission, the Division works with other federal agencies, state and local agencies, tribal
governments, the public, and the private sector. The Division coordinates with the Office of Air
and Radiation to ensure national consistency and strives to meet legal deadlines imposed by the
CAA.

ARD is organized into the following Branches:

•	Air Quality Branch

•	Energy and Resilience Branch

•	Air Permits, Toxics and Indoor Programs Branch

•	Grants and Program Support Branch

ARD administers the following programs:

•	State, Tribal, and Federal Implementation Plans (SIPs/TIPs/FIPs)

•	National Ambient Air Quality Standards (NAAQS) designations

•	Air permits

•	Air toxics

•	New Source Performance Standards (NSPS)

•	National Emission Standards for Hazardous Air Pollutants (NESHAP)

•	Maximum Attainable Control Technology (MACT)

•	Diesel Emissions Reduction Act (DERA)

•	Air grants

•	Tribal Air

•	Radon

•	Indoor air

•	Voluntary programs consultation, technical assistance and outreach (Energy Star, radon,
asthma, etc.)

•	Programmatic grant support, including state, tribal, air, and water grants


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1.4.8.1 Clean Air Act

ARD's air program relies on ambient air quality monitoring data and source emission data
collected by the New England States. The States collect ambient air quality monitoring data on
air toxics, ground-level ozone, ozone precursors, lead, nitrogen dioxide, carbon monoxide, sulfur
dioxide, and particulate matter. All six States have been delegated or authorized to enforce in
part or in full the following CAA programs: Part 60/NSPS, Part/61 and 63 NESHAPS, Sect.
Prevention of Significant Deterioration permitting, Title V/Part 70 permitting , Nonattainment
New Source Review (NSR) permitting, minor NSR permitting, and Indoor Radon/Section 306.

EPA funded programs involving data operations are required to conform to Agency and
Regional quality requirements, standards and guidance. LSASD works with the States to ensure
that quality assurance requirements are met. The States also prepare inventories of emissions
from sources. ARD requires the States to have adopted and used proper quality assurance
requirements in preparation of these emission inventories.

Quality assurance issues are addressed in SIPs which require Agency approval. For emissions
testing programs, including stack testing, pre-test reports are submitted by the regulated
community and are reviewed by the Field Service Branch of LSASD. The tests are then observed
to determine conformance with Federal reference methods and the data are evaluated to
determine adherence to the pre-test reports.

1.4.9 Office of Regional Council

The Office of Regional Counsel (ORC) Counseling Branch provides legal advice to Region 1
programs on the implementation of all environmental statutes and on the general legal
requirements applicable to the operations of the Region. This Branch also represents the Region
in any defensive litigation that arises from the Agency's actions in Region 1, either directly
before administrative bodies such as the Environmental Appeals Board or the Equal Opportunity
Employment Commission or in coordination with the Department of Justice when a case is in
federal court.

The ORC Legal Enforcement Branch provides legal advice and representation of the agency in
connection with enforcement and compliance assurance programs and statutes EPA administers
in the geographic boundaries of the region. The Legal Enforcement Branch Chief works closely
with the other Region 1 divisions, OECA, and Department of Justice (DOJ) to deliver a
comprehensive enforcement and compliance assurance program utilizing the entire spectrum of
compliance assurance tools available to the region.

ORC is organized into the following Branches and Sections:

•	Counseling Branch

•	Legal Enforcement Branch

o Superfund and Site Remediation Legal Enforcement Section
o Regulatory Legal Enforcement Section


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ORC administers the following programs:

•	Legal counsel

•	Litigation

•	Ethics

•	Regional Hearing Clerk
Freedom of Information Act (FOIA)

2.0 QUALITY SYSTEM COMPONENTS

This Section documents how EPA Region 1 quality system is
managed and defines the primary responsibilities for managing
and implementing each component of the system. The Regional
quality system provides a management structure that ensures
the quality of work and services pertaining to environmental
data throughout the organization. Specifically, it provides the
framework for planning, implementing, documenting, reporting
and assessing Regional activities relevant to environmental data
operations in keeping with the universally recognized quality
cycle. See also Section 1.1 Mission Statement.

The scope of this QMP precludes the need for additional QMPs by the organization; hence no
approval procedures have been developed for review of QMPs internal to the Region. However,
review and approval procedures for QMPs developed for extramural environmental activities are
documented in the most recent version of the EPA New England Standard Operating Procedure
for Reviewing Quality Management Plans.

The Regional data quality management system has evolved since first institutionalized in 1994. It
comprises several functional components that have matured into quality system programs,
including the:

•	Quality Assurance Proj ect Plan Program;

•	Performance Evaluation Program;

•	Assessment Program;

•	Data Review Program; and

•	QA Training Program.

The Regional quality system functions in coordination with allied programs, including:

•	Peer Review Program;

•	Human Subject Research Program; and

•	Information Quality Guidelines and Pre-Dissemination Review Program


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Quality system programs and components are implemented by policy memoranda and using a
variety of quality tools. These tools include National and Regional requirements and guidance
documents. The Regional guidance documents may be obtained from the OA Regional Web site.
and the Regional Science Council SharePoint site. Regional policies are available on the Intranet
site. Regional policies and SOPs are maintained on the LSASD Document Control System.
National documents may be obtained from the Enterprise Quality Management Web site.

The following table provides an overview of the Region's quality system programs, components,
and available tools. Detailed descriptions of these components including roles and
responsibilities for their implementation are provided in Sections 3 - 10 of this QMP.

Table 1. Summary of Regional Quality System Components, Tools and Requirements

Quality System

CIO Standard 2105-P-01-0, (formerly 5360 Al) EPA Quality Manual for Environmental Programs

Components

Tools

Quality System

EPA Region 1 QMP

Annual Quality System Review and Planning

QA Annual Report

Regional QA Policies

Management Memoranda

Quality Assurance Project Plan Program

EPA New England QAPP Program Guidance document
EPA OA Requirements and Guidance documents
Tracking Systems for project-related information

- LSASD Request for Assistance (RFA) Database

Components

Tools

Project Planning

EPA Region 1 Systematic Planning Process

Project QA Documentation

Project-specific QAPPs, Generic QAPPs, Program QAPPs,
Combined QMP/QAPPs, and equivalent QA documentation

Project QA Planning Documentation Review and
Approval Process

QAPP Review Procedures

Implementation

EPA OA Reauirements and Guidance Documents

-	New England Sample Tracking System (NESTS)

-	LSASD RFA Database

-	Region 1 Document Control System

-	QAFAP Standard Operating Procedures

Components

Tools

Representative Sampling

Sampling SOPs

Field Analytics

Field Analytical SOPs


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LSASD Sampling, Analytical, and QA SOPs

NERL Quality Manual

LSASD SOPs LSASD Document Control System

Performance Evaluation Samples

EPA New England Data Review Program Guidance
SPSWEB system

Assessment Program

Quality Assurance Branch SOP for Quality System Assessments and Technical Systems Audits
Tracking Systems

-	Superfund Performance Evaluation Sample Scoring Web (SPSWEB system)

-	LSASD RFA Database

Components

Tools

Management Assessment

Quality System Assessments

Guidance on Assessing Quality Systems, (QA/G-3)

Project Assessment

Technical Assessments including:

-Field Sampling Technical Systems Audits (TSAs)

-Field Analytical TSAs

-Field Laboratory TSAs

-Fixed Laboratory TSAs

-Split Sampling and Analysis Audits

-Data Package TSAs

-Data Validation TSAs

-Drinking Water Program Audits

EPA Region 1 Technical Systems Audit SOP
Project-Specific Audit Checklists and Audit Reports
Performance Evaluation Samples

Data Review Program (Verification, Validation and Usability)

EPA New England Data Review Program Guidance and Supplement documents
Tracking Systems

-	LSASD RFA Database

-	WEB New England Sample Tracking System (WNESTS)

Components

Tools

Data Review

EPA New England Data Review Program Guidance and Supplement.

Data Usability Assessment

EPA New England Data Review Program Guidance

EPA Guidance for Data Quality Assessment: Practical Methods for
Data Analysis (QA/G-9)

QA Training Program

Components

Tools


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QA Training Program

Types of Training
-Classroom
- Informal
-e-Training
-Conferences

EPA New England Standard Operating Procedure for QA Training
Documentation

Quality-related Internet and Intranet Sites

Components

Tools

Internet: EPA Resion 1 OA Home Pase

Links to:

-Training
-Services

-Quality System Documents

Intranet: EPA Resion 1 OA

Links to:

Regional QA Policies

Resional Science Council SharePoint Site

Links to:

-	Human Subjects Research

-	Peer Review

-	Information Quality Guidelines

-	Pre-dissemination Review

Peer Review Program

Program documented in Science Policy Council Handbook, Peer Review, 4rd edition, 2015
Tracking Systems

- National Science Inventory Database

Components

Tools

Agency-defined Peer Review Program

Resional Web site

Peer Review Call Letters/Memoranda

Information Quality Guidelines

Components

Tools

Pre-Dissemination Review Procedures for
Agency Information

Intranet EPA NEIOG & PDR Web rase Resional I mole mentation
Plan

IQG-PDR e-Training

3.0 PERSONNEL QUALIFICATIONS, TRAINING AND COMPETENCE

The Region implements procedures to assure all personnel performing work for EPA Region 1
have the competency to effectively accomplish their work. To achieve Regional quality goals
and objectives, management and staff performing tasks related to environmental data operations
must have the necessary skills and knowledge to effectively accomplish their work.


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3.1	Commitment to Training

It is Regional policy to provide and make available to management and staff the training,
including QA training, necessary to carry out their work successfully. Senior management takes
the lead in ensuring that the necessary levels of technical proficiency and QA knowledge are
maintained. In addition, senior management identifies mandatory training required by staff to
comply with program requirements.

3.2	Qualifications

Personnel must meet the minimum qualifications defined in the Office of Personnel Management
(OPM) Qualification Standards Handbook for their series and grade. The application of sound
QA policies and procedures requires that all personnel performing quality-related tasks
associated with environmental data operations have an appropriate level of knowledge of QA
procedures and principles.

The Human Resources Shared Service Center works with the Regional Human Resources Office
to ensure that all EPA positions are properly classified as to job series, title, and grade based on
an analysis of the duties of the position, as defined and submitted by the supervisor and manager
of record for the position, in compliance with OPM's position classification system. Each
classified position defines the principal duties, the knowledge required, the level of supervision,
and a variety of other factors used to determine the final grade level of the position. The
knowledge, skills, and abilities needed to perform the work of the position are incorporated as
part of the qualifications identified to fill the position. Applicants for QA positions must
demonstrate that they have the required knowledge, skills, and abilities to meet the qualifications
of the position.

It is also essential that the supervisor and manager of record for positions with QA
responsibilities ensure that incumbents have performance plans, critical job elements, and
performance standards reflecting their QA work each year, in compliance with EPA's
performance management system. In this manner, employees with QA responsibility will have
identified measurable goals and objectives for each year.

3.3	Professional Development and Training

The Region provides professional development and training, including QA training and field
measurement training (or use environmental data operations) through the Center for
Development and Learning, through external providers, and other means. E-training is also
provided through various venues including the EPA eLearning FedTalent training system.
Quality-related training is discussed further in Section 3.5. Needs assessments are conducted
periodically to identify training needs for the Region, such as training for Project Officers and
new hires. In-house training is also posted on the FedTalent training system. Registration for
training is accomplished electronically through FedTalent. The Human Resources Office is
responsible for maintaining records of employee training received through FedTalent and
received from sources external to the Region.


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3.4	Certifications

Formal certifications are required for various personnel in the Region. Personnel involved in
auditing and certifying State SDWA programs are required to successfully complete the SDWA
Certification Officer Training. A refresher training course is provided by the QAB prior to each
state laboratory audit.

Personnel involved in managing contracts are required to successfully complete Contracting
Officer's Representative (COR) training. The following are links for COR Certification and
recertification training requirements.

Personnel involved in managing grants (Project Officers and Grants Specialists) including,
cooperative agreements and interagency agreements are required to successfully complete the
Project Officers Basic Grant or Interagency Agreement Certification Training. The Project
Officers Refresher Course is required to be taken every three years.

Personnel in positions that require EPA-issued credentials must complete all initial and refresher
training required by EPA order 3500.1 (which also includes Health and Safety training required
by EPA order 1440.2). In addition, EPA Offices including OLEM, OAR, OECA, and OW,
require program-specific training related to the technical, operational, and administrative aspects
of environmental data operations.

Certificates are kept on file by the person certified.

3.5	Regional QA Training

The QAB works with the Regional Training Officer, Office Directors and their staff to assess
Regional QA training needs. The QAB provides support in developing general QA awareness
training and specific mandatory training.

Also, in conjunction with the Office Directors and program managers, the QAB identifies,
develops, and provides QA training to EPA contractors, States and other federal financial
assistance recipients.

Assessment team members receive appropriate training prior to conducting assessments in
accordance with Section 9.3 of this QMP.

QA training is based on prioritized needs and implemented as resources permit. QA training
provided by the QAB of EPA and non-EPA personnel is tracked in the LSASD RFA database.

3.5.1 QA Training Needs Assessment

The Region uses a multi-pronged approach to identify Regional QA training and re-training
needs.

1. Employee training needs are identified and documented during annual PARS reviews.


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2.	Training needs are identified through internal and external audits and management
systems reviews.

3.	Training is developed when new National and Regional quality-related policies are
issued.

3.5.2	QAB Staff Training

The RQAM evaluates the training needs of the QAB staff members during the PARS process. In
general, training for QAB staff includes attendance at one or more job-related training courses,
workshops, or professional meetings each year.

3.5.3	Financial Assistance Agreement Recipients and Contractors

The competency and training of personnel performing environmental data operations funded by
the Region under federal financial assistance agreements and contracts are evaluated through
quality system assessments, technical system audits, performance evaluation sample analysis,
and pre-award reviews of QA documentation (e.g., QMPs, QAPPs, SOPs) and accreditations, as
applicable. In addition, States participating in the EPANE/State QA Roundtable identify their
QA training needs. The Region provides QA training based on prioritized programmatic needs as
resources permit.

3.5.4	Regional QA Training Program and Outreach

3.5.4.1	Training

The Regional QA training is described in the EPA New England Quality Assurance Training
Documentation SOP available through the LSASD Document Control System.

3.5.4.2	Mandatory QA Training

Regional management determines which training is mandatory and for whom, and the frequency
of the training. Managers are responsible for ensuring that staff complete their required trainings.
Currently the following Regional QA training is mandatory:

•	Quality System Awareness Training is required for all EPA Region 1 personnel;

•	Project Officer Quality Assurance Awareness Training is required for EPA Project
Officers, Grants Specialists and supervisors;

•	QAPP training and/or QAPP Review Training is required for all Superfund RPMs, Site
Assessment Managers (SAMs), and RCRA Corrective Action RFMs; and

•	Laboratory Annual Ethics and Data Integrity Training is required for LSASD technical
staffs, managers and contractors.

3.5.5	QA Training Records Maintenance - QA Training Provided by EPA
Region 1

Procedures for maintaining records of training provided by the QAB are described in the most
current version of the Quality Assurance Unit Quality Assurance Training Documentation
Standard Operating Procedure (LSASD Document Control System.: EQASOPQATrainDoc).


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All trainings conducted by the QAB are logged in the QAB tracking database. Each entry
includes a copy of the training materials as appropriate and an attendance sheet.

3.5.6 QA Training Records - QA Training Provided by other Sources

QA training provided by sources external to the Region is tracked by the Regional Training
Office.

4.0	PROCUREMENT OF ITEMS AND SERVICES

Regional procedures for acquiring items and services that directly affect the quality of
environmental programs are documented. It is the Region's policy to specify the designated
quality assurance and quality control requirements when acquiring items and/or services that
relate to environmental data operations and environmental technologies. Regional policy also
requires that environmental data acquired, regardless of the mechanism, must be reviewed prior
to use and dissemination. Regional procurement functions and financial assistance agreements
are conducted in accordance with Federal Acquisition Regulations and related Agency policies,
directives, and guidance. Contractors, suppliers, and financial assistance recipients are
responsible for the quality of work performed directly for EPA and for items and services
provided by their subcontractors/sub-awardees and suppliers.

A graded approach to implementing QA/QC requirements is a key tenet of the Regional quality
system. The RQAM has the authority to establish "equivalent" quality requirements. All
deviations from the requirements set forth below must be documented in the
contract/program/project file.

4.1	Contracts

All procurements and contracts originating in the Region must meet established administrative
and QA requirements in the Federal Acquisition Regulations (FAR 46.202-4 and 52.246-11), the
EPA Acquisition Guide (EPAAG), Chapter 46 Quality Assurance, Section 46.2.1 Contract
Quality Requirements. The most recent Regional procurement policies regarding Quality
Assurance Review Forms (QARFs) are in the following memoranda and available on the
LSASD intranet website under Quality Assurance (QA) Requirements, Guidance and Tools.
See also the Appendices.

•	Quality Assurance Requirements for Non-SEMD Contract Actions (QARFs)

•	Quality Assurance Requirements for SEMD Contract Actions

These policy memoranda outline policies, procedures, and responsibilities. In procurements and
contracts where higher level quality requirements apply, appropriate contract clauses must be
used.


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For all new contracts or procurements, the Contracting Officer's Representative (COR) must
complete the EPAAG QA Review Form (QARF) in Appendix 46.2.1-D prior to forwarding a
request for procurement/contract placement.

After contract award, when requesting services either through the issuance of task orders, the
EPA Region 1 QARF must be completed and provided to the QA Office by the COR.

4.2 Financial Assistance Agreements

Financial assistance recipients are required to conform to applicable QA requirements as
specified in:

•	1 CFR1500.il, "Quality Assurance"

•	40 CFR Part 30, "Uniform Administrative Requirements for Grants and Agreements with
Institutions of Higher Education, Hospitals and Other Non-Profit Organizations"

•	40 CFR Part 31, "Uniform Administrative Requirements for Grants and Cooperative
Agreement to State and Local Governments"

•	40 CFR Part 35, "State and Local Assistance"

Specifically, organizations funded by the Region to conduct environmental data programs,
operations and activities are required to submit QMPs (or equivalent quality system
documentation) and QAPPs to EPA for review and approval. These programs include (but are
not limited to) "direct measurements or data generation, environmental modeling, compilation of
data from literature or electronic media, and data supporting the design, construction, and
operation of environmental technology". See also the Appendices.

4.2.1 Grants and Cooperative Agreements

The current Regional process for ensuring that financial assistance recipients meet QA
requirements was developed in 2000 and is revised annually to ensure compliance with and full
participation by all Regional programs with applicable policies and regulations pertaining to
quality in the award and management of grants, cooperative and interagency agreements. This
regional grants management process was initiated through the January 25, 2001 policy statement
Revised Quality Assurance Requirements for Grants.

This policy memo is reissued periodically to update procedural changes and to remind Project
Officers of their roles and responsibilities. The most current version of the Regional Grants QA
policy is available on the LSASD intranet website under Quality Assurance (QA)
Requirements, Guidance and Tools. See also the Appendices.

•	Grants & Cooperative Agreements

For continuing program grants that involve environmental data operations, QMPs (or equivalent
quality system documentation as approved by the RQAM) and QAPPs are required. There may
be situations where a QMP may not be appropriate such as one-time grants where only a QAPP


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would be required. The RQAM ensures that QAPPs for one-time grants or similar situations
contain sufficient information to describe consistent application of QA at the organizational
level.

The QA requirements memo describes the following process;

The Grant Project Officer determines if a QAPP is needed and the decision is
documented on the Funding Recommendation. If a QAPP is not needed, the appropriate
"Division IGMS QA Contact must concur with that decision on the Funding
Recommendation. If a QAPP is needed, the Project Officer incorporates the appropriate
special grant condition(s) into the grant award. Any modifications to the special grant
condition language must be reviewed and approved by the RQAM. Once the grant is
awarded, the Grant Project Officer works pro-actively with the grantee to ensure that the
QAPP is developed, completed and submitted to the RQAM for review and approval.
Grant Project Officers must also provide signature approval concurrence on QAPPs
produced under financial assistance agreements. Attachment 3 of the policy memo
identifies those organizations required to have a QMP.

QMPs and QAPPs will be prepared, reviewed and approved in accordance with the
specifications provided in Section 7.0 of this QMP. All QMPs and QAPPs are reviewed and
approved by the RQAM, or designated QAB staff, as received from the Grant Project Officer or
directly from the financial assistance recipient. The only exception to the required RQAM
approval is when QAPP approval authority has been delegated as discussed in Section 7.4.

4.2.2 Interagency Agreements

Interagency agreements funded by EPA Region 1 are subject to the requirements described in the
most recent policy memo available on the LSASD intranet website under Quality Assurance
(QA) Requirements, Guidance and Tools. See also the Appendices.

• Quality Assurance Review Forms (QARFs) Interagency Agreement Shared Service
Centers (IASSC)

These requirements are incorporated into individual agreements by IA Project Officers/Project
Managers. This policy memo is reissued annually to describe any procedural changes and to
remind personnel of their roles and responsibilities.

5.0 DOCUMENTS AND RECORDS

The Region implements appropriate controls for quality-related documents and records
determined important to the mission of the organization. The Federal Records Act of 1950, as
amended, requires all Federal agencies to make and preserve records containing adequate and
proper documentation of their organization, function, policies, decisions, procedures, and
essential transactions. These records are public property and must be managed according to
applicable laws and regulations.


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All records and documents used in administering this QMP and conducting environmental data
operations must be managed according to current Federal laws and regulations and EPA policy
and guidance specified in Section 5.4.

Records will be managed as an Agency asset throughout their life cycle, which consists of three
basic stages: creation, active maintenance and use, and disposition. The records life cycle is
initiated by the creation, collection, or receipt of records in the form of data or documents in the
course of carrying out EPA's administrative and programmatic responsibilities. The life cycle
continues through the processing and active use of the information in the record until the record
is determined to be inactive. The final step in the life cycle is disposition which frequently
includes transfer to inactive storage, followed by transfer to the National Archives or destruction.

Maintenance of documents and records (both printed and electronic) associated with the mission
of a given program or project is the responsibility of the Office which has primary responsibility
for that program or project. Each Office is responsible for establishing and implementing
procedures for identifying and managing records throughout their life cycle and ensuring that
procedures conform to established records retention schedules.

This Section of the QMP describes roles and responsibilities for ensuring records and documents
used to administer this Quality Management Plan are properly managed. Understanding roles
and responsibilities is essential because official Agency records are public assets and belong to
the government not to programs, by virtue of their possession, or to individuals, by virtue of their
position as Agency officials. Penalties for the willful and unlawful destruction, removal from
files and private uses of official records are found in 18 U.S.C. 2071.

5.1 Records and Documents Pertaining to the Quality Management Plan

In accordance with the most current EPA Order CIO 2105.0, the EPA Region 1 QMP must be
revised every 5 years and resubmitted to EQMD for review and signature approval by EPA's
Chief Information Officer (CIO). Also, the QMP must be reviewed annually and
changes/revisions must be reported in the QA Annual Report. Minor changes to the QMP do not
require EQMD signature approval.

The QMP is maintained in the LSASD Document Control System in accordance with the LSASD
Document Control User Manual. Superseded versions are archived in the database for reference.
All QMP citations must include the document control number and date of revision.

The QAB has been delegated the authority to and is responsible for developing Regional
guidance and procedures relevant to QA-related documents and records. The QAB identifies and
provides guidance for preparing quality-related records and documents in the following:

•	EPA New England QA Project Plan Program Guidance;

•	EPA New England Data Review Program Guidance; and


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The QAB assesses conformance to Regional requirements through assessments.

5.1.1	Records and Documents Pertaining to Environmental Data Operations

Each Office is the custodian of quality-related documents and records pertaining to
environmental data operations that it conducts and manages. As provided for in this QMP, the
QAB has a role in the review and approval of project-specific documents; however, each Office
must ensure the management of documents and records according to laws, statutes, policy and
program-specific guidance. Each Office is responsible for managing its QA-related documents
(both printed and electronic), including but not limited to:

•	Project-specific QA planning documents (e.g., QAPPs, SAPs, FSPs, QAPP addenda and
amendments);

•	Quality Management Plans;

•	Generic QAPPs, Program QAPPs and site-specific addenda and amendments;

•	Written procedures and other SOPs;

•	Data Review and Usability Reports; and

•	Technical System Audit Reports and Corrective Action Responses.

In addition, each Office is responsible for managing project-related QA/QC records (both
printed and electronic), including but not limited to:

•	Chain of Custody Records;

•	Field Sampling and Measurement Logs;

•	Deviations from approved QAPPs and SOPs;

•	Sample Results and Supporting Data; and

•	Communication Records

5.1.2	Document Control Requirements

Identifying documents and records (both printed and electronic) associated with the mission of a
given program or project is the responsibility of the Office which has primary responsibility for
that program or project. Each Office is responsible for establishing and implementing procedures
for preparing, distributing, filing, storing, protecting, accessing, and archiving documents and
records. The Manager is responsible for ensuring that proper procedures are implemented.

In addition, programs involved in environmental data operations follow Regional requirements
for quality-related records and documents. At a minimum, the approved QAPP and its addenda
and amendments, SOPs, technical assessments, corrective action responses, data usability
determinations, and final project/site reports are to be filed together according to the Office's file
structure guidance. The specific file system used by each program is the responsibility of the
individual Managers.


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For those programs delegated QAPP approval authority (refer to Section 7.6.1), the authorized
program representative must maintain the official copy of the completed Title and Approval
Page with approval signatures (or other record of approval) and provide a copy to the QAB for
each project specific QAPP.

5.1.2.1	LSASD Document Control Procedures

The handling of LSASD controlled documents is described in the NERL Quality Manual, QAB
Document Control SOP, and the SOP for the Management of Standard Operating Procedures.
Controlled documents include manuals, plans, policies, guidance, SOPs, forms and other
documents used to implement management systems. The electronic document control system is
available through the LSASD intranet page. Controlled documents are accessible to all LSASD
personnel as portable document format (PDF) files. Only the electronic document viewed on-line
is a controlled document. Printed copies are not considered controlled copies, and a caveat
stating this is included with each SOP.

Archived versions are maintained in order to permit reconstruction of historical practices. Write
access for entering, editing, and archiving controlled documents is limited to designated
Document Control Contacts. Documents which are still current but were developed prior to the
implementation of the electronic system, are maintained as hard copies in the appropriate
LSASD Branch.

5.1.2.2	QAB Documents and Records

All QAB work is logged into the Request for Assistance (RFA) Database. Each assignment is
automatically assigned a sequential RFA number and tracked in accordance with the RFA
Manual. In March of 2012, the database was upgraded to accommodate digital storage of
documents.

Hard copies of documents and records may also be maintained in the QAB file room by RFA
number for 5 years in accordance with the LSASD QAB File System SOP. After five years,
records are disposed of in accordance with program records retention regulations, policies and
Regional procedures.

5.2 Ensuring Documents and Records Accurately Reflect Completed Work

Each Office is responsible for establishing and implementing procedures for ensuring the
consistency and technical accuracy of its work products. In accordance with the EPA New
Ensland Information Quality Guidelines - Pre-dissemination Review Implementation Plan. each
Office will use established review procedures to ensure that disseminated information products
are of adequate quality for their intended use. Specifically, all Regional information products
must be reviewed prior to their dissemination to ensure these products meet established quality
guidelines for objectivity, utility and integrity.

5.3 Establishing and Implementing Chain of Custody and Confidentiality


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Procedures

Each Office is responsible for establishing and implementing chain of custody and
confidentiality procedures, including confidential business information (CBI). It is the Manager's
responsibility to ensure that required procedures and security are implemented and comply with
current EPA policies.

5.4 Regulations, Policies, and Guidance Pertaining to Documents and
Records

The Region adheres to all Federal regulations, statutes, laws and policies and guidance pertaining
to documents and records as specified at: http://www.epa.gov/records/laws/index.htm. It also
conforms to Agency Records Disposition Schedules. These include, but are not limited to:

•	44 U.S.C. Chapter 31, Records Management by Federal Agencies;

•	44 U.S. C. Chapter 33, Disposal of Records; and

•	18 U.S.C. Chapter 101, Records and Reports;

The EPA Region 1 SEMS Records and Information Center (SEMS RIC) supports the Superfund
Enterprise Management System - Records Management (SEMS-RM) and maintains the EPANE
SEMS Portal.

Guidance, Site File Structure procedures, Document Coding forms, training and contact
information are provided through the Intranet site.

6.0 COMPUTER HARDWARE AND SOFTWARE

EPA's ability to fulfill its mission is dependent upon a strong information technology
infrastructure and reliable electronic information products. The Environmental Information
Program is responsible for managing the Agency's information functions, including information
collection, technology infrastructure, access and security. Within the Environmental Information
Program, the Office of Information Management (OIM) establishes information technology (IT)
policies, standards and procedures to ensure that information technology components integrate
properly into the overall IT infrastructure and that Agency-owned environmental databases
provide accurate data. OIM has also developed information product standards to ensure that
information deliverables can be readily integrated and used for a varied range of uses.

The Region conforms to OIM's IT policies, standards, and procedures. In addition, Service
Bulletins are periodically issued by the Mission Support Division (MSD) to address Information
Management issues including e-mail, data retention, data back-up, data storage, etc. Consistent
with the Region's IOG-PDR procedures, the Region expects that all information and
environmental data acquired from IT methods and sources are evaluated prior to use using
systematic planning procedures described in Section 7.0 Planning.


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6.1	Roles and Responsibilities

The designated Senior Information Officer (SIO) for EPA Region 1, as part of the SIO network
supporting the CIO, is responsible for ensuring consistent Agency-wide management of
information technology, information management and the integrity of electronic data.

6.1.1	Hardware and Software

The Information Services Branch within the Office of Mission Support (OMS) is responsible for
the following computer hardware and software support activities:

•	Installing, configuring, testing, and troubleshooting network operating system and LAN
based application software;

•	Troubleshooting and solving problems for the LAN server, data switches and routers, and
any related gateways and communications equipment;

•	Supporting personal computer (PC) hardware and software procurement, system
configuration, testing and installation of PC and peripheral equipment;

•	Coordinating system software and hardware changes for PC equipment;

•	Troubleshooting and fixing software and hardware problems reported by users;

•	Overseeing PC and LAN security;

•	Ensuring security software, system patches, system controls procedures and policies are
implemented to prevent introduction of malicious software and computer viruses as well
as to prevent unauthorized system/network access by hackers via the Internet; and

•	Reviewing security practices to ensure that appropriate levels of information security are
maintained. This includes review and implementation of policies and practices such as
those that apply to user IDs and passwords, remote access, Internet, server system/data
backup and recovery, physical access to Regional data center and communication closets.

6.1.2	Computer Models

Project Managers and Project Officers are responsible for ensuring all activities involving the
development, modification, evaluation and/or application of mathematical or computerized
models of environmental processes and conditions are performed under an approved QAPP.

6.2	Regional Information Management Systems

All information management system development, improvements, and updates will comply with
Information Resources Management Policy Manual CIO 2100 and will include a systematic and
comprehensive dialogue among the data providers, data and system users, and system developers
prior to the design and installation of the system.

It is Regional policy to work closely with information system customers, as well as OMS and
National Program Offices, as appropriate, on all phases of system development, improvements,


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and updates, including contractor-developed systems and those developed by other entities.
During all life cycle phases of information management systems, the Region will comply with
requirements within the Information Resources Management Policy Manual, the System Life
Cycle Management Policy, and the System Life Cycle Management Procedure.

6.3	Hardware and Software Requirements

The Region conforms to QMS policies, standards and guidance pertaining to hardware and
software, and the Enterprise Architecture Policy CIO 2122.0. Through its procurement
procedures, the Region ensures that purchased hardware and software meet user requirements
and conform to OMS's technology and procurement guidelines.

6.4	Data Standards

It is Regional policy to comply with all applicable Federal regulations, guidance, executive
orders, and internal policy documents concerning data standards, and Data Standards CIO
2133.0. These include EPA's core information data standards: The Locational Data Accuracy
Standard, the Facility Identification Standard, the Groundwater Data Element Standard, the
Chemical Abstract Number Standard, and the Electronic Transmission of Lab Measurements
Standard. It is the responsibility of individual Offices within the Region to be aware of the
current standards and regulations.

Other relevant data product standards include standards for Web product development contained
in the EPA Web Guide and two related EPA Orders: 2190.1 Cookies and other User Tracking
Methods and 2190.2 Children's Privacy and Copyright Issues.

The EPA Data Standards Program is established and documented in the Information Resources
Management Policy Manual. Within EPA, adherence to data standards policy is accomplished
through the direction of OMS and the Senior Information Officer (SIO) network. EPA's
information product-related policies apply to all EPA organizations and personnel, including
contractors, Senior Environmental Employee (SEE) Program participants, and other personnel
assigned to EPA who design, implement, and maintain information management systems and
products for the Region.

6.5	EPA Region 1 Internet and Intranet Site Responsibilities and
Procedures

The Regional Web Content Coordinator is responsible for information products posted on the
Regional Web site. The EPA Region 1 Communication Group maintains the Regional Internet
Web site. This requires a three-pronged approach focused on the following issues: 1) content
creation and maintenance; 2) navigation through the Web site; and 3) maintaining and
incorporating new Web technology. The Communications Group comprises Communication
Coordinators from the various Offices, staff from the Regional Administrator's Office and Web
technical staff.

All Web site requests are treated as information products used by EPA to represent or support


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Agency positions and policies. Therefore, requests are managed in accordance with the
Information Quality Guidelines through the EPA Region 1 Web site. Requests for Web site
dissemination of information, reviews, and managerial concurrence are managed through the
Video/Internet/Design Information (VIDI) system.

It is Regional policy to conform to the EPA Intranet Publishing Guidelines.

7.0	PLANNING

Regional policy requires the use of systematic planning according to the Guidance of Systematic
Planning Using the Data Quality Objectives, EPA QA/G-4, and the Region 1 Systematic
Planning Process (Table 1) to ensure that all data, including existing data, and information are of
the needed and expected quality for the desired use.

The G-4 planning process elements include: Organization, Project Goal, Schedule, Data Needs,
Criteria, Data Collection, Quality Assurance, and Analysis.

7.1	Region 1 QAB Planning Procedures

The QAB uses the Request for Assistance (RFA) database, a management tool, to plan, track,
and report assistance, for internal and external clients. The RFA database serves to expedite
client requests, allocate workloads, meet work schedules, and ensure that QMPs, QAPPs and
other planning documents are reviewed and approved in a timely manner.

The QAB provides several general and program specific QAPP development tools on the R1
Quality Systems Documents Internet page. This site provides examples of various project
QAPPs, in addition to the following specific QAPP tools:

•	Brownfields

•	Environmental modeling

•	Water quality monitoring

•	Secondary/Existing data projects

For media programs, many of the National Program Offices have developed programmatic data
quality objectives and model QAPPs, the Region typically uses the National guidance and/or
model QAPPs. The Region adopts a graded approach for the development of a QAPP, based on
program-specific guidance, for planning, documenting, and assessing environmental projects.
QAPP elements are addressed using the systematic planning process and are commensurate with
the objectives and intended use of the data.

The RQAM and QAB staff, as project team members, provide QA recommendations and
technical assistance when planning projects and developing project quality objectives. However,
the ultimate project and data quality decisions are made by the program. It is the program's
responsibility to properly plan the project to ensure that the collection or use of data/information


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are the right type, quantity, and quality needed to support the objectives.

7.2	Quality Management Plans (QMPs)

In accordance with EPA Order CIO 2105.0, EPA organizations and extramural organizations
funded by EPA that conduct environmental data operations are required to operate under quality
systems that conform to ANSI/ASQ E-4 specifications and are documented in a Quality
Management Plan (QMP).

Therefore, the Regional quality system is planned, developed, and documented in this QMP in
accordance with the most current EPA Order CIO 2105.0. This QMP is reviewed and approved
by EQMD. Implementing the QMP is a shared responsibility among all Regional personnel; the
RQAM is responsible for overseeing the implementation of the quality system. To that end, the
RQAM maintains a current QMP, resubmits the QMP to EQMD whenever major revisions are
necessary or at a minimum of every five years, and performs annual reviews of the quality
system.

For organizations funded by EPA Region 1, a quality system must be planned, developed, and
documented in accordance with applicable Federal Regulations for Acquisition and Financial
Assistance Agreements. QMPs, or equivalent organizational quality system documents, are
required by the Region. Equivalent documentation of a quality system is determined on a case-
by-case basis by the RQAM (Section 4.2.1). All extramural QMPs and other organizational
quality system documentation is reviewed and approved by the RQAM or designated QAB staff.
The QAB reviews and approves QMPs in accordance with the EPA New England Standard
Operating Procedure for Reviewing Quality Management Plans (LSASD Document Control
System). QMPs are not required for all grants, for example one-time grants.

Federally funded organizations are responsible for keeping their QMPs (or equivalent
documentation) current, performing annual reviews of their quality systems, and resubmitting
their QMPs whenever major revisions are necessary, when so directed by EPA NE, or at a
minimum of every five years. The QAB maintains a tracking database that provides the status of
State, Tribal and Interstate organization QMPs, and the status of contractor QA documents that
have been reviewed and approved.

In conjunction with members of the EPA Region 1/State QA Roundtable, the Annual Quality
System Status Report Template was developed as guidance for organizations required to report
annually on the status of their quality systems. Areas of reporting include assessments, training
needs, notable QA issues/activities for the year, and current QAPPs.

7.3	Quality Assurance Project Plans (QAPPs)

The Regional QAPP Program requires that the results of the systematic planning process are
documented in a QAPP (or in an equivalent QA planning document). Equivalent documentation
is determined on a case-by-case basis by the RQAM and QAB staff and is based upon the project
quality objectives and the intended use of the data.


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Approved QAPPs are required for all environmental data operations. Project Managers and
Project Officers are responsible for ensuring that the results of the systematic planning process
are documented in an approved QAPP prior to starting project activities.

The Region has adopted a graded approach to project activities, including the preparation and
review of QAPPs. However, to be approved, a QAPP must include sufficient information to
document a transparent process that supports the achievement of project objectives.

7.3.1	Types of QAPPs

The Region supports the use of project specific QAPPs, Generic QAPPs and Program QAPPs as
defined in the EPA New England QAPP Program Guidance.

The Region encourages the use of Generic and Program QAPPs whenever practicable. The QAB
is available to provide technical assistance to the States, Tribes and local governments for
developing them. Approved generic and program QAPPs are supported by site-specific or
project-specific addenda or SAPs which address the issues unique to each site or project. The
generic and program QAPP will specify the preparation, review, and approval of site-specific or
project-specific addenda. EPA may authorize the Lead organization to approve site-specific and
project-specific addenda. This authorization is contingent upon a review and approval process
that is fully documented in the generic and program QAPP.

7.3.2	QAPP Review/Approval Process and Turnaround Time

The Regional review procedures for QAPPs are detailed in the EPA New England Standard
Operating Procedure for Reviewing Quality Assurance Project Plans in the LSASD Document
Control System.

The time required to review and approve a QAPP is dependent on whether the initial submission
of the QAPP provides appropriate and sufficient project information. In order to allow for
comment and response, organizations are requested to submit an approvable QAPP to the QAB a
minimum of 60 calendar days before the initiation of work. An approvable QAPP is one that is
complete, includes adequate information to describe project activities and the quality objectives
are well defined. The information must be sufficiently transparent to allow a re-creation of the
data collection or use activity.

7.3.3	Implementing and Revising QAPPs

Approved QAPPs must be implemented as written, however, a QAPP may be modified and
amended to be current and accurate. Modifications may be necessary to address changing
site/project conditions and to ensure project objectives are met. Modifications must be
documented in an amendment and undergo the approval process, which is similar to the new
QAPP approval process.

QAPPs are generally approved for a fixed time period specific to the environmental


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data/information operation. They must be kept current and revised whenever necessary and when
so directed by the Region or National Program Office. The QAPP should be reviewed annually,
and this annual review should be documented and submitted to the original approval authority
(i.e., EPA QAB and/or Superfund RPM, State authority).

7.4 QAPP Approval Authority

All environmental data operations conducted by EPA or funded by EPA must have an approved
QAPP in place prior to the initiation of data collection. The RQAM has the authority and
responsibility to approve all extramural and intramural environmental data operation QAPPs,
unless delegated as described in the Regional QMP (refer to 7.4.1 and 7.4.2). In addition, Project
Officers must also provide signature approval concurrence on QAPPs produced under financial
assistance agreements.

7.4.1 Delegation of QAPP Approval Authority

7.4.1.1	EPA Region 1 Delegation

In accordance with EPA Order CIO 2105.0, the RQAM may authorize a representative, as
defined in the approved QMP, to review and approve QAPPs. Delegation of QAPP approval
authority does not preclude review by the QAB. Regional QA staff are available for technical
and QA assistance upon request.

In EPA Region 1, the RQAM has authorized Project Managers in the Superfund and RCRA
Corrective Action programs to review and approve QAPPs prepared for EPA by contractors,
other Federal agencies, States, and those QAPPs submitted by the regulated community under
voluntary and consensual or unilateral enforcement agreements, decrees and orders. Superfund
and RCRA Corrective Action Project Managers are required to provide a completed copy of the
approval documentation to the QAB after they review and approve the QAPP.

Delegation of authority is contingent upon Project Managers attending QAPP training,
conforming to this QMP, and providing the required approval documentation to the RQAM.

Records of current and expired authorizations of QAPP approval authority are maintained by the
QAB on the LSASD S/Quality Assurance directory.

7.4.1.2	State Agency or Environmental Program Delegation

The RQAM may authorize a State agency or an environmental program the authority to approve
QAPPs from clients. For example, QAPP approval authority could be delegated to an entire
Department of Environmental Protection, or the approval authority could be limited to just the
Water Quality program. Delegation of QAPP approval authority does not preclude review by the
QAB. Regional QA staff are available for technical and QA review assistance upon request.

Delegation of approval authority is contingent upon concurrence by the environmental program
manager within EPA Region 1. In addition, the organization must:

• Document and implement an effective quality system;


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•	Use a systematic process to plan projects, identify clients, determine project quality
objectives, select technical and QA/QC activities for the project;

•	Convene project scoping meetings as appropriate;

•	Document results of systematic planning processes in QA planning documents, i.e.,
QAPPs;

•	Document and implement procedures for reviewing and approving QAPPs prior to the
initiation of work; and

•	Document and implement assessment and oversight programs that will ensure project
activities are conducted as planned and non-conformances will be corrected.

Records of current and expired delegations of QAPP approval authority are maintained by the
QAB on the LSASD S/Quality Assurance directory.

8.0	IMPLEMENTATION OF WORK PROCESSES

Work processes must be implemented appropriately to ensure that environmental information
collected and used by and for the Region is of the needed and expected quality for the objective.
To that end, the Region documents technical and administrative procedures for the collection and
use of environmental information in all environmental programs including monitoring,
regulatory enforcement, and permitting.

It is the policy of the Region to implement data and information collection activities according to
an approved QAPP, by reference Standard Operating Procedures (SOPs) and all other associated
documents and/or regulations. QAPPs are required to include written descriptions of all technical
and QA/QC activities that will be performed.

8.1	Regional Procedures

Regional procedures are documented to ensure consistency in the collection and use of
environmental information and data products. Documented procedures are used to ensure
consistency, continuity of operations, serve as a basis for auditing, assist in training, and
succession planning. LSASD SOPs are maintained in the LSASD Document Control System
(DCS). EPA Region 1 uses EPA QA Field Activities Procedures (QAFAP) for field
investigations. QA refresher training reinforces the importance of planning and documenting
environmental activities.

8.2	Standard Operating Procedures (SOPs)

For routine activities, the Region uses Standard Operating Procedures (SOPs) for documenting
procedures and a consistent application of processes. Some activities with SOPs include;

QAFAP field investigations, inspections, analytical methods, data handling procedures, and
QAPP review, etc. These written protocols serve to ensure a standardized and consistent
approach for work processes.


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EPARegion 1QMP1
US EPA Region 1 Quality Management Plan

Date: July 21, 2020
Rev.: 1.0
Page 46 of 59

Standardization of sampling, analytical, and review procedures provides a basis for generating
information that is useful for determining whether objectives were achieved. Deviations from
approved SOPs are documented and maintained with project records for usability determination.
Documented protocols also serve as a basis for technical assessments.

8.3	Responsibility for Regional Procedures and SOPs

The responsibility for identifying operations that need written procedures/SOPs, and for
preparing, updating, approving, withdrawing, and archiving procedures, ultimately lies with the
Manager. The determination for when an SOP is or is not necessary, is through collaboration
between staff performing the work and management. However, it is incumbent upon all staff to
identify operations which need SOPs and/or revisions to remain current.

Managers are responsible for ensuring that Office procedures are implemented appropriately.
Managers can use a variety of mechanisms to accomplish this, including direct oversight of work
being performed, comparability of work products between staff, and results of assessments.
Written procedures/SOPs are to be clearly and concisely written so that a person with the
appropriate technical background can follow the procedure without interpretation or assumption.

Written procedures are initially prepared by staff and revised when necessary. Managers are
responsible for the final review, approval, and subsequent periodic review and revision of Office
procedures. Office procedures must be current and readily available to all personnel. Managers
are responsible for ensuring that the most recent version of an Office procedure/SOP is followed.
Modifications to current procedures must be documented and have supervisory concurrence.
Outdated procedures are withdrawn from work areas and archived when no longer relevant.
Archived procedures/SOPs should be maintained to allow for reconstruction of historic practices.
In addition, Managers are responsible for implementing other record keeping procedures specific
to their Office and program.

For compliance with CIO 2105-P-02.0 (EPA QA Field Activities Procedure) Region 1
established several regional standard operating procedures including an Oracle-based Document
Control System to house all controlled documents related to field activities. It is available
through the Region 1 intranet page. All Region 1 QAFAP SOPs can be accessed here.

8.4	LSASD SOPs

LSASD manages the SOP process with the LSASD SOP for the Management of Standard
Operating Procedures and copies of all LSASD SOPs and the QAFAP SOPs, are maintained in
the LSASD Document Control System (DCS) in accordance with the LSASD Document Control
System User Guide. The LSASD Quality Assurance Officer, QAO, is responsible for the SOP for
the Management of Standard Operating Procedures. EPA staff and contractors are required to
read and attest to all SOPs relevant to their work. The "reading and attesting to" SOPs by
personnel is managed electronically for management and staff to oversee the process.

Controlled documents are accessible to all LSASD personnel as portable document format (PDF)


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files. Only the electronic document viewed/maintained on-line is a controlled document. Printed
copies are not considered controlled copies, and a caveat stating this is included with each SOP.

Archived SOPs are maintained in the DCS which allows for the reconstruction of historical
practices, as necessary. DCS access for uploading and maintaining controlled documents is
limited to management and SOP/document custodians.

8.5	Inspection and Oversight of Work-Related Processes

Program Managers and Project Officers are responsible for program oversight. They monitor
work conducted by and for the Agency at the project level. Regional processes described in
Section 9 of this QMP are used to ensure that approved QAPPs, technical procedures,
documents, and SOPs are implemented as written. Data review and environmental information
evaluation procedures are used to monitor project deliverables, ensuring data usability and that
project objectives are met. Corrective actions resulting from performance monitoring are
resolved, confirmed and documented.

Managers oversee the work products of their staff and are responsible for reviewing data and
information products prior to their dissemination.

8.6	Tracking and Reporting QAB Activities

The QAB tracks projects in the Request for Assistance (RFA) database. In accordance with RFA
procedures, relevant project information (acceptance and due dates, requestor, service requested,
etc.) are entered by QA Unit staff.

The RQAM uses the reporting features of the RFA and SOP Document Control System (DCS) to
generate reports for management and reporting purposes. Cumulative tracking information is
generated and reported as necessary.

9.0 ASSESSMENT AND RESPONSE

EPARegion 1 QMP 1
US EPA Region 1 Quality Management Plan

Date: July 21, 2020
Rev.: 1.0
Page 47 of 59

EPA Region 1 documents processes and procedures to determine the suitability and effectiveness
of the implemented quality system and the quality performance of the environmental programs.

To measure the effectiveness and performance of the Regional quality system, the QAB
coordinates an assessment program for Regional environmental programs such as states, tribal
nations and interstate organizations. The assessment process is described in the EPA New
England SOPs for Quality System Assessments and Technical System Audits.

9.1 Region 1 Quality System Assessment

The Regional quality system is assessed annually and may include responding to an OMS
request for a QA Annual Report. The QA Annual Report may be requested by OMS, EQMD and
the reporting elements may vary from year-to-year. Annually the QAB requests, compiles, and
reviews information regarding Regional quality resources and activities that may include 1)
quality management resources, 2) QA/QC training - provided and received, 3) quality system-


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EPARegion 1QMP1
US EPA Region 1 Quality Management Plan

Date: July 21, 2020
Rev.: 1.0
Page 48 of 59

related accomplishments, and 4) assessments performed and received.

The process used by the QAB for planning, implementing and documenting assessments and
reporting results to management is described in the LSASD QAB SOPs for Quality System
Assessments and Technical System Audits.

9.1.1 Assessment Tools

Selection of the appropriate assessment tool depends on whether a quality or technical system
will be performed. Technical system assessment tool selection may also depend on the stage of
the project during which the assessment is conducted. Tool types for quality system assessments
and various technical assessments are in the tables below.

Quality System & Technical Assessment Tools

Quality System

Appropriate Tool Type

Comments and
Examples

Quality System

Quality System
Assessment (QSA);
Management System
Review

Assesses conformance
to a documented quality
system through the
collection of information
and documented
evidence of the system
implementation.



Technical Assessments

Appropriate Tool Types

Examples

Planning

Site Scoping Meeting;
Site Visit; QA Project
Plan Review

Site Scoping; Site Visit;
QAPP Review

Sampling

Technical Systems Audit
(TSA)

Field Sampling TSA
(example, Low Flow
Ground Water TSA)

Analysis

Technical System Audit;
Performance Evaluation
Sample (PES)

Field Analysis TSA

Field Lab TSA

Fixed Lab TSA

PES Analysis/Scoring

Data Evaluation and
Reporting

Data Review, Validation
and/or Audit

See Section 9.9 - Data
Review, Validation and
Verification, and Data
Usability Reporting


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EPARegion 1QMP1
US EPA Region 1 Quality Management Plan

Date: July 21, 2020
Rev.: 1.0
Page 49 of 59

Data Usability

Data Usability

See Section 9.9 - Data



Assessment

Review, Validation and





Verification, and Data





Usability Reporting

Specific tools utilized by the Region are described in QA SOPs and/or other appropriate
documents.

9.1.2	Data & Information Review, Verification, Validation, and Usability
Reporting

Another assessment tool, among other requirements Agency quality policies and standards, is
that results obtained from products or services involving environmental data and information
shall be reviewed, verified, validated and qualified, prior to decision making, or data/information
usage. Specific data and information review procedures, roles and responsibilities are described
in applicable guidance and planning documents, including QAPPs or other equivalent
documents.

The regional implementation documents include, the EPA New England Environmental Data
Review Program Guidance and EPA New England Environmental Data Review Supplement.

9.1.3	Assessor Qualifications, Responsibilities and Authority

Qualifications - QAB members that lead assessments have apprenticed under senior members of
the Branch prior to and during an assessment.

All LSASD team members participating in Chemistry, Microbiology and Cryptosporidium
assessments of the State drinking water programs must have successfully completed a laboratory
certification course offered by the OGWDW Technical Support Center, Cincinnati and must be
familiar with quality assurance and quality control practices necessary to support data integrity,
usability and defensibility. Radiochemistry assessments are performed by an EPA contractor as
there currently is no Certification Officer training for radiochemistry. The QAB leads refresher
training for drinking water program assessors prior to the first on-site evaluation of the
assessment year. Personnel conducting laboratory assessments under NELAC or the new TNI
Standards are required to have the appropriate assessor training. Similarly, teams evaluating
NELAP Accreditation Bodies are required to have evaluator training.

As described above, quality system assessors need to have direct experience with the
implementation of quality systems before conducting these assessments. Similarly, personnel
leading technical systems audits should have experience or familiarity with the technical
procedures they are auditing, including reviewing Quality Management Plans, Quality Assurance
Project Plans and Standard Operating Procedures, as appropriate. When resources are available,
a minimum of two assessors is preferred for conducting assessments. In addition to increasing


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EPARegion 1QMP1
US EPA Region 1 Quality Management Plan

Date: July 21, 2020
Rev.: 1.0
Page 50 of 59

the degree of experience, this practice increases the level of competence and helps to prevent
disputes over findings. The Assessment Lead and the RQAM review assessment plans to ensure
that the designated assessors have no direct involvement or responsibility for the work being
assessed, and that there are no real or perceived conflicts of interest.

9.1.3.1	Responsibilities

Assessors are responsible for planning, conducting, evaluating, documenting and reporting
assessments. They are also responsible for follow-up to the assessment and evaluation of the
response actions. Assessors' roles and responsibilities are described in the Assessment SOPs.

9.1.3.2	Authority

The authority to assess is derived from the most current version of EPA Order CIO 2105.0.
Assessment authority is confirmed in the planning stage for each assessment. The purpose, scope
and time frame for the assessment are documented in an assessment plan. For quality system
assessments, the Lead Assessor and the organization's point of contact for quality assurance
concur on the assessment's purpose, scope and time frame. For technical systems audits, the Lead
Assessor and the Project Manager concur on the assessment's purpose, scope and time frame.
Confirming the authority to assess in the planning stage of an assessment allows access to
programs, managers, documents/records, and provides the organizational freedom to identify
both problems and noteworthy practices, propose recommendations, and verify implementation
and effectiveness of corrective actions.

9.2 Internal Assessments

9.2.1 Region 1 Quality System Assessment Procedures

EPA Order CIO 2105.0 requires EPA organizations to perform an annual review of their Quality
System (QS), and when requested, submit a Quality Assurance Annual Report to the Office of
Mission Support (OMS), Environmental Quality Management Division (EQMD). When an
Annual Report is requested, the Region prepares the report which addresses QA activities for all
environmental data and information programs, including the oversight of delegated activities,
and those specific to the QAB. The OMS request includes the reporting elements and format.

When the annual report is not requested by EQMD, the RQAM generates internal reports to
assess the Region 1 Quality System.

Internal assessments include; a) As part of requested reporting to OMS/EQMD, the Regional
quality system is reviewed as described in Section 9.1. b) LSASD, LSB assessments are
performed annually, c) TSAs, Data Evaluation and Reporting, Data Usability, and various other
assessments are performed on an ongoing basis, d) As appropriate, QAB assessments of internal
programs.

When necessary the RQAM assists with reviewing plans for internal audits, corrective action
plans and follow-up, for EPA Region 1 field sampling and measurement activities, for
compliance with CI02015-P-02.0 EPA QA Field Activities Procedure.


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Annually Peer Review activities are compiled, documented, and reported according to Peer
Review Guidance or current procedures.

9.2.2 LSASD Management Reviews

EPARegion 1QMP1
US EPA Region 1 Quality Management Plan

Date: July 21, 2020
Rev.: 1.0
Page 51 of 59

As part of LSASD's quality system, the LSASD management team (Division and Deputy
Directors, LSB, FSB, and QAB Branch Chiefs) and QAO, meet annually to conduct a review of
the laboratory's Laboratory Services, Field Services, and Quality Assurance Branch activities to
ensure services are suitable, appropriate, effective, and consistent. The management team
meeting also is a time to identify necessary Division wide changes or improvements. The
meeting is an opportunity to evaluate the following items:

•	Suitability of policies and procedures,

•	Reports from managerial personnel,

•	Recent internal & external audit/assessment results,

•	Corrective and preventive actions,

•	Results of proficiency tests,

•	Changes in volume and type of work,

•	Client feedback and complaints, and

•	Other relevant factors, such as QA activities, resources and staff training.

The results of this annual review are documented in the Division Director's files. Any corrective
actions identified by this review are tracked as part of the Office-wide problem tracking system
to ensure appropriate action is taken according to an acceptable time schedule.

9.2.3 Technical Assessments

Technical Assessments are identified through project planning procedures including; the Quality
Assurance Review Form (QARF), Project Manager's requests, Scoping Meetings, Quality
Assurance Project Plans or comparable documents, etc. The Region's strategy is to conduct
technical assessments as early as practicable in a data/information collection activity to identify
potential problems and prevent the generation of data/information that do not meet the project
objectives. Data audits may be useful in the early stages of a project, while data usability
assessments may be conducted at the end of a project to evaluate overall usability to determine if
the project objectives were achieved. In the Superfund program, performance evaluation samples
PES) are included with each sample delivery group (SDG) of samples, for each matrix, analytical
parameter, and concentration level, as available. The PESs are considered an assessment for a
specific time period.


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EPARegion 1QMP1
US EPA Region 1 Quality Management Plan

Date: July 21, 2020
Rev.: 1.0
Page 52 of 59

9.3	External Assessments Performed

9.3.1	Air Monitoring Programs

a.	New England States - comprehensive Technical Systems Audits (TSA) including
evaluation of program quality system scheduled every three years. Performance Audits,
NPAP TTP and PEP Program Audits complement the TSAs.

b.	New England Tribes with air programs - TSA scheduled every three years in same
year as State where Tribe resides.

9.3.2	State Certification Programs for Drinking Water Laboratories

a.	Connecticut, Maine, Massachusetts and Rhode Island - Evaluation performed by the
Region under the Agency's laboratory certification program every three years.

b.	New Hampshire and Vermont - Assessment performed under NELAC Standards by
NH Environmental Laboratory Accreditation Program with observation by Regional
Office every two years (Effective July 1, 2011, laboratories are assessed to The NELAC
Institute (TNI) Standards, adopted September 2009.)

9.3.3	State Principal Laboratories Analyzing Drinking Water

a.	Connecticut, Maine, Massachusetts and Rhode Island - Assessment performed by the
Region under the Agency's laboratory certification program every three years.

b.	New Hampshire and Vermont - Assessment performed under NELAC Standards by
NH Environmental Laboratory Accreditation Program with observation by the Regional
Office every two years (Effective July 1, 2011, laboratories are assessed to The NELAC
Institute (TNI) Standards, adopted September 2009.)

9.3.4	Environmental Agencies/Organizations

a.	New England States - The goal is for quality system assessments to be conducted
every three-to-five years, as resources allow.

b.	New England Interstate Organizations - The goal is for quality system assessments to
be conducted every three-to-five years, as resources allow.

9.4	Internal and External Assessment Reporting and Response

The quality system and technical assessments conducted by QAB personnel are tracked in the
Request for Assistance (RFA) database. The assessment process and reporting are described in
the EPA New England SOPs for Quality System Assessments and Technical System Audits.

Assessment and audit outcomes must include a written report which summarizes the assessment
activities, includes the findings, and, provides recommendations for response actions, as
appropriate.

The objective of the report is to communicate assessment results to the responsible level of
management. Efficient communication of results allows management to implement timely,
effective response actions so that the quality objectives can be met. Quality system assessments


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are typically reported to senior managers of the organization responsible for the work.
Assessments of project activities are reported to the EPA Project Manager. Copies of reports for
internal assessments of project activities conducted by Lead Organizations also are sent to the
EPA Project Manager. The EPA Project Manager may request a review of an audit report by the
QA Unit. The process for reporting results of project assessments to EPA managers is described
in Section 5.0

Senior managers of the assessed organization are responsible for ensuring that any deficiencies
found in quality system assessments are appropriately addressed. Project Officers and Project
Managers are responsible for ensuring that findings from assessments of project activities are
appropriately addressed and copies of reports are provided to the RQAM.

9.5	Corrective Actions

The assessment process is described in the EPA New EnglandSOPs for Quality System
Assessments and Technical System Audits.

The principal responsibility for the implementation of response/corrective action is that of the
assessed organization. A written response is provided by the assessed organization for all
assessment findings with objective evidence of the effectiveness of the correction, and with
specified time frames for those actions in progress or to be done by a future date. For project
activities, copies of all documentation relative to the corrective action and response must be
included in the final project report. The authority and responsibility for verifying the timeliness
and effectiveness of corrective action resides with the senior management ultimately responsible
for the work that was assessed.

9.6	Dispute Resolution

If a dispute is encountered during an assessment and/or follow-up activity, then the dispute
resolution process outlined in Section 1.3.8 of this QMP would be applied.

10.0 QUALITY IMPROVEMENT

EPARegion 1 QMP 1
US EPA Region 1 Quality Management Plan

Date: July 21, 2020
Rev.: 1.0
Page 53 of 59

EPA Region 1 continuously evaluates and improves the quality system. All Regional personnel
are responsible for identifying, planning, implementing, and evaluating conditions which maybe
adverse to quality. Adverse conditions must be prevented, identified, and corrective actions
implemented promptly, evaluated and tracked to closure to ensure actions are effective. The
Region's senior management is fully committed to quality improvement as a process by which to
proactively address vulnerabilities and to enhance efficiency. The Regional Administrator
submitted a region wide message regarding the R1 Suggestion Box located on R1 Connect. This
is a mechanism for everyone to contribute toward improvement and efficiency in the region.

Quality improvement is incorporated as a core organizational element of the Region's quality
culture and philosophy and looks to correct systemic problems, improve consistency, streamline
processes, re-engineer ineffective work procedures, and customize quality tools. Management
and staff are encouraged to establish communications among themselves and with customers and


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EPARegion 1QMP1
US EPA Region 1 Quality Management Plan

Date: July 21, 2020
Rev.: 1.0
Page 54 of 59

suppliers to explore areas for improved service. R1 personnel are expected to identify areas for
process improvement and to actively participate in problem solving.

10.1	EPA Lean Management System (ELMS)

In November of 2018 the Office of Continuous Improvement (OCI) initiated the EPA Lean
Management System (ELMS). The R1 deployment of ELMS was in April 2019. ELMS
implementation invites teams to come together (standing, sitting, in-person or via Skype) through
huddle meetings, problem solving sessions, and improvement events to examine processes to
make EPA's functions timelier and more accurate.

10.2	Roles and Responsibilities

Roles and responsibilities for identifying, planning, implementing and evaluating the
effectiveness of quality improvement activities are interwoven throughout the fabric of the
organization and have been discussed throughout this QMP. The R1 processes and procedures
are intended to prevent quality issues, correct, solve documented quality issues from
identification to resolution, all within a timely manner. Issues are identified, corrected as soon as
practical, corrective actions are implemented, evaluated for effectiveness, and the process is
documented by program personnel as issues are identified and corrected.

Quality issues may be referred to the QAB for evaluation and assistance. The QAB evaluation
will determine if it is:

•	An isolated non-conformance with Regional policies, requirements or procedures;

•	A recurring systemic problem requiring "re-engineering" the quality system component,
work processes and procedures, and/or training to prevent reoccurrence of system failures
and deficiencies; and/or

•	A result of inconsistent implementation of work procedures and/or quality system
processes.

The QAB documents quality issues and makes recommendations for corrective actions, revising
procedures and training, as applicable. Corrections and/or modifications made to work processes
and procedures, are documented in new or revised standard operating procedures (SOP), or the
appropriate equivalent document. It is management's responsibility to communicate to staff
issues that have been identified and the resolution. All personnel are encouraged to identify areas
for improvement, share the information with management and QAB personnel as appropriate,
and a collaborate to address situations that have been identified.

Enhancements to components of the quality system are documented in revisions and
amendments to the QMP. The QMP is reviewed annually to ensure that all the information is
current and relevant. Approximately every five years, or when major changes to the quality
system dictate updating the QMP, the RQAM reviews the document and submits a revised QMP
to EQMD for review and approval.


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EPARegion 1QMP1
US EPA Region 1 Quality Management Plan

Date: July 21, 2020
Rev.: 1.0
Page 55 of 59

The approved Regional QMP is posted on the LSASD Web page. Quality system components
and tools, including guidance documents and access to standard operating procedures, are also
posted on Regional internet and/or intranet sites.

10.3	Annual Reporting

A QA annual review provides the opportunity for the Region to identify areas of performance as
well as components of the quality system that require correction or improvement. A QA annual
review serves to communicate quality issues to senior management to assist in prioritizing
workloads and allocating resources to support quality needs. Under EPA Order CIO 2105.0,
when requested, the Region reports annually to OMS the status of the Regional quality system.

10.4	Organizational Improvement Based on Assessments

As discussed in Sections 8 and 9, the RQAM uses both external and internal assessment findings
to initiate quality improvement. The RQAM, in collaboration with the QAB and QA
Representatives, identify root causes of deficiencies; make recommendations for improvement;
work with Regional management, staff and external partners to implement corrective actions;
and subsequently, evaluate the effectiveness of corrective actions to substantiate necessary
changes.

10.4.1	External Quality System Assessments

The EQMD typically conducts an assessment of the Region 1 quality system every three-to-five
years. In addition, National Program Offices may perform assessments of Regional programs.
These assessments serve to periodically evaluate the effectiveness of the quality system and
quality-related procedures for Regional environmental programs; ensure consistency across the
ten Regions; and to identify Agency quality system issues.

The results of Regional Quality System Assessments are communicated to the Regional
Administrator and RQAM. The RQAM works directly with senior management to plan and
implement corrective actions and to modify the quality system when and where appropriate. In
addition, the RQAM may assist Offices within the Region when responding to national
assessments of their environmental programs.

10.4.2	Internal Assessments

The goal is to conduct internal assessments as frequently as resources allow. The RQAM
communicates the findings and results of internal assessments to the affected program managers.
As a follow-up to internal and external quality system assessments, the RQAM monitors the
effectiveness of corrective actions and evaluates improvements that have been made to the
quality system.


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EPARegion 1QMP1
US EPA Region 1 Quality Management Plan

Date: July 21, 2020
Rev.: 1.0
Page 56 of 59

ATTACHEMENT 1 - ACRONYMS

AIRS - Aerometric Information Metric System

ANSI - American National Standards Institute

AQS - Air Quality System

ARD - Air and Radiation Division

ASQ - American Society for Quality

CAA - Clean Air Act

CBI - Confidential Business Information

CFR - Code of Federal Regulations

CIO - Chief Information Officer

CLP - Contract Laboratory Program

COR - Contracting Officer Representative

CWA - Clean Water Act

CWSRF - Clean Water State Revolving Fund

DCS - Document Control System

DD - Division Director

DDD - Deputy Division Director

DERA - Diesel Emissions Reduction Act

DOJ - Department of Justice

DRA - Deputy Regional Administrator

DWSRF - Drinking Water State Revolving Fund

EC AD - Enforcement and Compliance Assurance Division

ELMS - EPA Lean Management System

EPA - Environmental Protection Agency

EPA AG - EPA Acquisition Guide

EPCRA - Emergency Planning and Right- To- Know Act

EPRB - Emergency Planning and Response Branch

EQMD - Enterprise Quality Management Division

ESAT - Environmental Services Assistance Team

FAR - Federal Acquisition Regulation

FASTAC - Field and Analytical Services Teaming and Advisory Committee

FIFRA - Federal Insecticide, Fungicide and Rodenticide Act

FMFIA - Financial Integrity Federal Managers Financial Integrity Act

FOIA - Freedom of Information Act

FSB - Field Service Branch

FSP - Field Sampling Plan

GIS - Graphic Information System

HQs - Headquarters

IA - Interagency Agreement

IASSC - Interagency Agreement Shared Service Centers
IGMS - Integrated Grants Management System
IQG - Information Quality Guidelines


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EPARegion 1QMP1
US EPA Region 1 Quality Management Plan

Date: July 21, 2020
Rev.: 1.0
Page 57 of 59

ISO - International Organization for Standardization
IT - Information Technology
LAN - Local Area Network

LCRD - Land, Chemicals, and Redevelopment Division

LS ASD - Laboratory Services and Applied Science Division

LSB - Laboratory Services Branch

LUST - Leaking Underground Storage Tanks

MACT - Maximum Attainable Control Technology

MPRSA - Marine Protection, Research, and Sanctuaries Act

MSD - Mission Support Division

NAAQS - National Ambient Air Quality Standards

NE - New England

NELAC - National Environmental Laboratory Accreditation Conference
NELAP - National Environmental Laboratory Accreditation Program
NERL - New England Regional Laboratory

NESHAP - National Emission Standards for Hazardous Air Pollutants
NESTS - New England Sample Tracking System
NH - New Hampshire

NPAP - National Performance Audit Program

NPDES - National Pollutant Discharge Elimination System

NPL - National Priority List

NSPS - New Source Performance Standards

NSR - New Source Review

OAR - Office of Air and Radiation

OCI - Office of Continuous Improvement

OECA - Office of Enforcement and Compliance Assurance

OGWDW - Office of Ground Water and Drinking Water

OIM - Office of Information Management

OLEM - Office of Land and Emergency Management

OMS - Office of Mission Support

OPM - Office of Personnel Management

ORA - Office of the Regional Administrator

ORC - Office of Regional Counsel

OSC - On-Scene Coordinator

OW - Office of Water

PARS - Performance Agreement Reporting System

PC - Personal Computer

PCB - Polychlorinated Biphenyl

PCS - Permit Compliance System

PDF - Portable Document Format

PDR - Pre-Dissemination Review

PEP - Performance Evaluation Program

PES - Performance Evaluation Sample


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EPARegion 1QMP1
US EPA Region 1 Quality Management Plan

Date: July 21, 2020
Rev.: 1.0
Page 58 of 59

PRP - Potentially Responsible Party

PWSS - Public Water System Supervision

QA - Quality Assurance

QAB - Quality Assurance Branch

QAFAP - Quality Assurance Field Activities Procedures

QAO - Quality Assurance Officer

QAPP - Quality Assurance Project Plan

QARF - Quality Assurance Review Form

QC - Quality Control

QMP - Quality Management Plan

QS - Quality System

QSA - Quality System Assessment

RA - Regional Administrator

RCRA - Resource Conservation and Recovery Act

RFA - Request for Assistance

RFM - RCRA Facility Manager

RIC - Records and Information Center

RPM - Remedial Project Manager

RQAM - Regional Quality Assurance Manager

SAMs - Site Assessment Managers

SAP - Sampling and Analysis Plan

SDG - Sample Delivery Group

SDWA - Safe Drinking Water Act

SDWIS - Safe Drinking Water Information System

SEE - Senior Environmental Employee

SEMD - Superfund and Emergency Managment Division

SEMS - Superfund Enterprise Management System

SEMS-RM - Superfund Enterprise Management System - Records Management
SIO - Senior Information Officer
SIPs - State Implementation Plan
SOP - Standard Operating Procedure

SPSWEB - Superfund Performance Evaluation Sample Scoring Web

TMDLs - Total Maximum Daily Load

TNI - The NELAC Institute

TSA- Technical System Audit

TSCA - Toxic Substance Control Act

TTP - Through the Probe

US - United States

UST - Underground Storage Tank

VIDI - Video/Internet/Design Information

WD - Water Division


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EPARegion 1QMP1
US EPA Region 1 Quality Management Plan

Date: July 21, 2020
Rev.: 1.0
Page 59 of 59

LIST OF APPENDICIES

1.	Fiscal Year 2020 Requirements for Implementing Quality Assurance Policies for
Assistance Agreements - Grants and Cooperative Agreements. May 2019.

2.	Region 1 Procedures and Responsibilities for Implementing the Quality Assurance
Review Form (QARF) for Interagency Agreements (IAs) through the Interagency
Agreement Shared Service Center (IASSC). August 2018.

3.	Quality Assurance Requirements for Contract Actions. Quality Assurance Review Form
(OARFl July 2018.

4.

Regional Organizational Charts


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