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Quality Management Plan

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Quality Management Plan for Region 2

Table of Contents

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Section 1: QUALITY SYSTEM FOUNDATION

Section 1 of the Region 2 Quality Management Plan (QMP) contains in 1.A. the basic Introduction to the Quality System (QS), which states the mission, policy underlying the QS, and in 1.B. the description of how the organizational structure of the Region supports the implementation of the QS, stressing the roles and responsibilities of groups and individuals within the Region. This section of the QMP, including the Mission and Scope, Quality Policy, and Quality System subsections, describes the Region's goals and policies related to the generation and use of environmental information. It also describes the system that is in place to make this all happen. It is closely linked with the Organizational Structure subsection, which describes, among other things, how the large and small groups within the Region are organized and how the individuals within that structure work together to accomplish the mission described here. You may find your own role and responsibilities in the overall Quality System described here.

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1.A. Introduction

1.A.1. Mission, Policy and Scope

Region 2's Quality Policy

All environmental information operations conducted in the Region, and all those conducted for it are to be of known quality, adequate for their intended use, with all aspects of their collection and analysis thoroughly documented with such documentation being verifiable and defensible.

EPA's mission is to protect human health and the environment. To accomplish that mission, EPA utilizes Environmental Information from a variety of sources. Almost everything we do is directly dependent upon the collection and use of environmental information. In the context of this QMP and the Region's Quality System, "environmental information" means "environmental data," but also includes less quantitative descriptions of the environment or processes involving it. The Policy supporting Region 2's Quality System ensures that all of the environmental information collected and/or used is of known quality, adequate for its intended use, with all aspects of collection and analysis thoroughly documented; such documentation being verifiable and defensible.

Quality Glossary - A listing of QA related terms and their definitions can be found at www.epa.gov/quality/glossary.htm

This policy, and the Quality System designed to accomplish it, are based on the various statutes and directives that authorize and direct EPA's overall mission to protect public health and the environment. More specifically, the Quality System mission itself is authorized and directed by the national EPA Order 5360.1 A2, (www.epa.gov/quality/qs-docs/5360-1.pdf) which directs components of the Agency to establish and implement Quality Systems. The Order, along with references to the rest of the new Policy documents, clearly define the Agency's policies regarding environmental data operations to which the Region's Quality System complies, in part through the development and implementation of this QMP. The QMP has been signed, and authorized for implementation, by all of the Senior Managers in the Region and by the Director of the Headquarters Quality Staff.

The scope of this Quality System is broad:

  • organizationally addressing environmental information operations conducted by the Regional staff, our grantees (from large states to municipalities and universities), our contractors (from those working routinely on site to those who may work on specific projects our Federal Government partners), the regulated community and volunteer organizations;
  • functionally encompassing planning, collection and analysis, review and assessment, use, and documentation of environmental data;
  • including a diversity of data types such as: the results of monitoring the quality of the air, water, waste, land, flora, and fauna; measurements of the regulated community's emissions, discharges, and processes; and results of research on the environment; as well as
  • other information subject to the Information Quality Guidelines (IQGs) (available at www.epa.gov/quality/informationguidelines).

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1.A.2. Regional Laboratory QMPs

Three laboratories operate within Region 2, the Regional Laboratory, the Brownfields Mobile Laboratory and the Ambient Air Quality, Air Standards Laboratory. All three are located within the Division of Environmental Science and Assessment. All three have quality management plans which document the overall laboratory management systems, policies, responsibilities and procedures.

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1.B. Quality System Organizational Structure, with Roles and Responsibilities

Within Region 2's Organizational Structure, there are defined implementation roles and responsibilities, authorities, accountability, lines of communication and processes to manage the quality of environmental information. The structure of the regional Quality System ensures that appropriate resources are effectively dedicated to implementation of the Region 2 Quality Assurance program at all organizational levels, and is managed by an independent Regional Quality Assurance Manager (RQAM).

The Region's Organizational Structure, as shown in Appendix A, is headed by the Regional Administrator (RA), Deputy RA and their staff. There are 8 Divisions, each headed by a Division Director, along with a number of small Offices. The Quality System is overseen by the Regional QA Manager (RQAM), who reports directly to the Director of the Division of Environmental Science and Assessment (DESA, in Edison, NJ), and has direct access to the Deputy RA through explicit incorporation in the RQAM's Performance Agreement. Region 2 has a functionally centralized QA Program, with program-specific Quality Assurance staff providing QA document review, data review, project oversight, technical support, and analytical services support to Regional Programs. The RQAM is supported by three groups of QA Officers in three different branches in DESA. The QAOs are located in the Hazardous Waste Support Section (HWSS), the Air and Water Quality Assurance Team (AWQAT), and the Laboratory Branch (LAB). This Centralized QA System consolidates the QA decision-making, assessment (auditing), guidance, and training functions in a central core, yet allows delegation of authority for day to day QA activities to staff in the various Divisions and Offices.

The independence of the RQAM and QA Staff is not only required by national EPA policy (EPA Order 5360.1 A2, www.epa.gov/quality/qa_docs.html), but is vitally important to the Region's implementation of its Quality System, allowing the RQAM the authority to advocate the importance and relevance of quality in EPA's work. The RQAM is able to serve without any potential conflicts of interest due to his/her location in the Office of the Director of DESA, outside any sub-group that collects and/or uses environmental information directly, and with explicit ties to the Deputy RA to resolve any potential conflict of interest posed by the RQAM's organizational location in DESA. The formal mechanism for resolving any QA issues or disputes with program divisions are presented by the DESA Division Director to senior regional management for resolution.

The three groups of Quality Assurance Officers (QAOs) in DESA also maintain independence. While there are environmental information operations in the three branches housing the QAO groups, the two self-contained groups, along with the separate laboratory QAO, exist solely for the purpose of conducting quality-related activities, thus supporting their functional independence. Additionally, they are encouraged to elevate any conflicts or disputes within their branches (or elsewhere) to the RQAM for resolution or further elevation.

The Region 2 website at www.epa.gov/region02/science/ contains contact information for the current RQAM, along with the QAOs and their supervisors.

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1.B.1. Authorities and Accountability for Managing the Quality System

Everyone Has Responsibilities in a Quality System

Any Quality System is a group effort. The Region's QA staff does only SOME of the QA. Region 2 Program Staff all have QA responsibilities for specific projects.

While the RQAM and QAOs in the Region's Centralized QA System perform many QA functions, essential elements of the Region's Quality System are the responsibility of others in the Region, from the Regional Administrator (RA) to individual staff members. This section of the QMP details their roles and responsibilities, along with the authorities and accountabilities that go along with them.

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1.B.2. Quality System Roles, Responsibilities, and Authorities

1.B.2.a. Individual's Quality System Roles, Responsibilities, and Authorities
Regional Policy on Use of the UFP-QAPP

On November 8, 2005 a memorandum from George Pavlou, Director of ERRD formalized the implementation of the OSWER Directive 9272.0-17 with DESA by applying the Uniform Federal Policy for QAPPs to all fund-lead and responsible party lead environmental investigations for CERCLA, RCRA and Brownfields projects in Region 2.

  1. Regional Administrator (RA)

    Overall responsibility for the QA Program in Region 2 rests with the Regional Administrator (RA). The RA is committed to ensuring that the Quality System is developed and implemented with adequate resources allocated for accomplishment of program and Regional goals in the development and execution of all projects and tasks involving environmental information, both in-house and extramural.

  2. Deputy Regional Administrator (DRA)

    The DRA is responsible for day to day operation of all Region 2 programs. As part of this, the DRA is responsible for the effectiveness of the Region's Quality System. The DRA provides independent upper management access to the RQAM. The DRA will also ensure the development and implementation of corrective actions in conformance with external and/or internal assessments.

  3. Regional Quality Assurance Manager (RQAM)

    Planning, oversight and policy recommendations are the responsibility of the RQAM, as authorized in the RQAM's Performance Agreement. The RQAM is scheduled to: (1) hold quarterly meetings with the QAOs to discuss national and regional QA concerns (2) brief the DESA Division Director at weekly DESA Branch Chief meetings and, (3) participate in the monthly national RQAM Conference call among RQAMs and OEI Quality Staff. The DESA Division Director discusses current QA issues, when necessary, at weekly regional senior staff meetings with the RA.

    Specific QA responsibilities of the RQAM and the Regional Quality Assurance Officers (QAOs), who are located in three Branches within DESA, are shown in Table 1. For clarity, those activities routinely performed by the QAOs are designated by H, M, or L for Hazardous Waste Support Branch, Monitoring and Assessment Branch, and Laboratory Branch, respectively.

  4. Regional Quality Assurance Officers (Regional QAOs)

    QA Officers (QAOs) serve under the general guidance of the Region 2 RQAM, but functionally report to their respective DESA Branch Chiefs, who communicate with the RQAM concerning the work load and accomplishments of their respective QAO activities.

    The QAOs in the Hazardous Waste Support Branch perform centralized QA activities for regional RCRA permitting and corrective action programs, Superfund Brownfields, Emergency Response, Removal, Pre-remedial, Remedial programs, and the Region 2 Mobile Laboratory.

    QAOs in the Air and Water Quality Assurance Team in the Monitoring and Assessment Branch perform QA activities for: Water, Air, FIFRA and TSCA programs as well as other areas.

    The QAO for the Region 2 Laboratory is located in the Laboratory Branch. The QAO is responsible for ensuring compliance with and implementation of all QA/QC policies and practices as outlined in the laboratory QMP.

    As indicated in Table 1, some QA responsibilities are routinely performed by some or all of the QAOs. In addition to Table 1, the RQAM activities may be delegated to QAOs on a case-by-case basis, while the QAOs may offer various levels of assistance on other activities, as requested or as warranted. In addition, other Region 2 DESA staff may be called upon from time to time to perform certain QAO activities, such as participating in audits or reviewing QAPPs, based on their particular capabilities and the specific need.

  5. Divisional Management

    QA is intended to be an integral part of every Region 2 Program that is associated with environmental measurements. Managers are responsible for providing and managing adequate resources to assure that all data and environmental information in support of their respective programs are of known quality and adequate for their intended use.

    Division Directors have overall responsibility for ensuring that Division Managers are knowledgeable and implement respective QA responsibilities outlined in the Region 2 QMP. Acceptance of these responsibilities is indicated by signature on the Regional QMP.

    Branch Chiefs, Section Chiefs and Team Leaders are responsible for assuring that their respective staff carry out all collection, analysis, and assessment activities for environmental data or information in accordance with Region 2 Quality Assurance policies and procedures. This includes: 1) implementation of the systematic planning process, 2) development and implementation of QAPPs, 3) development and implementation of corrective action plans, 4) development, maintenance and approval of SOPs, and 5) identification of program-specific QA training and/or resource needs.

  6. Project Officers (PO), Contract Officer Representatives (COR), and Project Managers (PM) across the Region

    Regional staff who serve as Project Officers, Contract Officer Representatives, and Project Managers have specific QA roles and responsibilities independent of those assigned to general staff in their organizational unit. They are responsible for the quality of information produced or used for their respective Programs, Contracts, and Projects, etc., in accordance with EPA Region 2 Quality System requirements. They must ensure that work plans and contract deliverables include appropriate QA documentation. They must ensure use of the systematic planning process and identify the need for any technical and performance evaluations.

    • In the Superfund, Brownfields, and RCRA Programs, PMs and POs for projects that involve the collection and/or use of environmental information have specific roles and responsibilities. The PMs include: On-scene Coordinators (OSCs), Remedial Project Managers (RPMs), Brownfields Project Managers, and RCRA Project Managers. They are responsible for ensuring an EPA approved QAPP using the Uniform Federal Policy for Quality Assurance Project Plans (UFP-QAPP) guidance www.epa.gov/fedfac/documents/qualityassurance.htm is in place before beginning the collection or use of environmental information. For projects performed by Potentially Responsible Parties (PRP) PMs ensure that enforcement instruments contain this requirement. PMs also ensure that the PRP QAPPs are reviewed by Region 2 technical personnel. PMs retain approval authority over both fund-lead and PRP-lead QAPPs. When PMs oversee grants and/or contracts they are also called Project Officers (POs).

      For work performed by Region 2 contractors, PMs ensure that the Scope of Work (SOW) requires the contractor to prepare QAPPs that are compliant with the UFP-QAPP guidance and other Region 2 QA requirements. They are also responsible for ensuring that Interagency Agreements (IAG) with the US Army Corps of Engineers (USACE) contain QA requirements as noted above. The POs and PMs serve as liaisons between the EPA QAOs and their contractors/USACE.

    • In the Air, Water, TSCA, FIFRA, and other programs, Project Officers (POs) and Project Managers for projects that involve the collection and/or use of environmental information have specific roles and responsibilities. These individuals include program staff who:

      1. Serve as official Project Officers/Project Managers for grants and contracts and Interagency Agreements (IAGs)
      2. Serve as the Agency contact for other external projects, such as test or monitoring projects being conducted for the Agency by the regulated community
      3. Are in charge of in-house projects that involve environmental information.

      POs also serve as liaisons between project management and the appropriate QAO within AWQAT. In general, this includes:

      1. Transmitting information about the QA requirements - particularly the requirement to have a Quality Assurance Project Plan (QAPP) approved prior to the start of work.
      2. Performing a preliminary review of the QAPP
      3. Forwarding the screened QAPP to AWQAT
      4. Ensuring the eventual correction of deficiencies and signing the QAPP.

      For all programs, POs for Grant projects involving environmental information have the added responsibility for ensuring that the requirement for QA is correctly indicated in the Integrated Grants Management System (IGMS) along with all follow-up questions, as appropriate. This will include ensuring that an organizational level QMP and/or a project level QAPP is in place, in consultation with a QAO, based on the graded approach. In addition, the POs must ensure that sufficient funding and time are allocated for the completion of the appropriate QA activities.

      POs for IAGs have the added responsibility for ensuring that the QA requirements are documented in the Scope of Work for an environmental information IAG project (item 13. on the EPA Form 1610-1 includes the QA requirements that a QAPP will be prepared for the work to be performed).

      PMs for internal environmental information projects have dual responsibilities of serving as the liaison with the appropriate QAOs and for ensuring that the project conforms to all of the Region's QA requirements.

    • Contract Officer Representatives (CORs) for contracts involving environmental information must utilize the QA Review (QAR) form to document the need for QA involvement in those contracts. CORs are also responsible for documenting QA requirements in the Scope of Work. QA requirements include development and implementation of EPA approved QMPs, QAPPs, etc. in accordance with EPA Agency and Regional policy, in consultation with a QAO and based on the graded approach. In addition, the CORs perform oversight, evaluation and auditing functions and must ensure that sufficient funding and time are allocated for the completion of the appropriate QA activities.

Table 1. Routine QA Responsibilities among the Regional QAM and QAOs
R = Regional QA Manager (RQAM)
H, L, M = QAOs in Hazardous Waste Support Branch, Laboratory Branch,
Monitoring and Assessment Branch
Responsibility R H L M
Recommend policies and procedures for managing QA/QC within the Region X X X X
Develop and revise the Regional QMP X      
Review and approve all state, local, tribal, EPA contractor and other grantees QMPs X X   X
Oversee the QA annual review and work plan process X      
Act as the official contact in the Region for all QA matters and communications from OEI Quality Staff, other Regions and Headquarters personnel X      
Act as the official contact in the Region for QA matters and communication with the States, Indian Nations, and the private sector.   X   X
Maintains tracking system to ensure that all organizations with Region 2-approved QMPs conduct and report on annual reviews and updates of their QMPs. X      
Provide QA guidance and training to Regional and state personnel   X   X
Ensure timely review and updating of regional QA SOPs and QAPPs. X X X X
Assist Region 2 personnel in the preparation and review of Quality Assurance Project Plans (QAPPs), Standard Operating Procedures (SOPs) and data usability assessments   X   X
Review and sign the QA Review Form for contracts X X   X
Conduct systems reviews, performance audits and data usability assessments   X   X
Review and approve QAPPs for Regional monitoring projects   X X X
Review and approve SOPs to ensure adherence to QA/QC policies X X X X
Provide QA advice and guidance to EPA grantees and contractors, ensuring conformance with their QMPs and other QA requirements   X X X
Oversee compliance with Regional QA Program requirements   X X X
Submit periodic reports to Regional management and OEI Quality Staff X      
Conduct certification evaluations of state drinking water laboratories     X X
Review data submitted by EPA staff, contractors, grantees, potentially responsible parties, and the regulated community when requested   X X X
Manage Regional and state information for the national proficiency testing programs     X X
Act as a focal point for EPA methodology requirements   X X X
Review Alternate Test Procedure applications     X X
Ensure that QA activities or tasks that arise are addressed appropriately   X   X
R H L M

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1.B.2.b. Organizations' Quality System Roles, Responsibilities, and Authorities

Caribbean Environmental Protection Division (CEPD)

The Division consists of a Division Director, a Deputy Division Director, 3 branches and a Virgin Islands (VI) Coordinator. In general, it serves as the program lead for and contact with the Commonwealth of Puerto Rico and the Territory of the Virgin Islands. The Division does not currently have contracting responsibilities. Contracts for the type of projects addressed under the QMP are done at the Regional level. The Division is responsible for Quality System activities for all of the programs under its responsibility in the Caribbean, and all projects performed for or as part of them. CEPD is also responsible for assuring that data from the regulated community and other outside sources are used appropriately.

Public Affairs Division (PAD)

PAD develops, implements and coordinates communications for the Region and plans and oversees community relations, public outreach and intergovernmental activities. This division serves as a focal point for relations with the print and broadcast media, Congressional, state and local elected officials, public interest groups and concerned community members, and works to ensure that the public is informed about the Agency's policies and programs. It operates a regional speakers bureau, produces public information materials and events, and is responsible for managing the Region's environmental education program, Superfund community relations, the Region 2 Web site and the Freedom of Information Act control office. It is not normally directly involved with environmental monitoring programs, except through the environmental education program and promoting the public's understanding of Regional monitoring work.

Division of Enforcement and Compliance Assistance (DECA)

The Division consists of five branches, two teams and a Deputy Division Director all reporting to the Director. It is responsible for compliance and enforcement activities for all of the Region's regulatory programs. Project Officers have the responsibilities described in the Project Officer's Subsection. DECA is also responsible for assuring that data from the regulated community and other outside sources are appropriate for use by the Agency.

Division of Environmental Planning and Protection (DEPP)

The Division consists of a Director, two Deputy Division Directors and three Senior Policy Advisors, six branches and a Long Island Sound (LIS) Office. The latter is jointly administered by Regions 1 and 2 to support the LIS Management Conference. The Division staff are responsible for the QA activities in a number of areas because of its leadership in overseeing many large and small grants and contracts. Project Officers have the responsibilities described in the Project Officer's Subsection. DEPP is also responsible for assuring that data from the regulated community and other outside sources are appropriate for use by the Agency.

Division of Environmental Science and Assessment (DESA)

The Division consists of the Director, the RQAM, a Science Officer, a Regional Science Liaison to ORD, and three branches that all report to the Division Director. The QA responsibilities for this Division fall into three basic categories: QA Management, Project Management, and Environmental Project execution. The QA Management responsibilities are described in the RQAM and Regional QAO Subsections. Project Officers have the responsibilities described in the Project Officer's Subsection. DESA is also responsible for assuring that data from the regulated community and other outside sources are appropriate for use by the Agency.

In addition DESA operates three separate laboratories. These include a: 1)Laboratory Branch which is a full service chemical, biological, and microbiological laboratory; 2) Mobile Laboratory (in the Hazardous Waste Support Branch) which is a trailer-based lab for analyzing organics and other parameters either at its home base in Edison, NJ or on-site, routinely at Superfund, Brownfields or Emergency sites; and 3) Ambient Air Quality Stardards Laboratory, (in the Monitoring and Assessment Branch) which performs routine QA services for the ambient air program. All three laboratories have their own Quality Management Plans (QMPs).

Emergency and Remedial Response Division (ERRD)

The Division consists of a Director and a Deputy Division Director, and six branches. The Division manages regional CERCLA and Brownfields activities, remedial and removal activities, emergency responses and incidences of national significance. The QA responsibilities within the Region are: 1) to ensure that contracts, IAGs and enforcement instruments include a requirement that the contractor, PRP and/or Agency implement a Quality System that complies with EPA Region 2 requirements; 2) to ensure that field investigations are performed with a QAPP that has been approved by Region 2; and 3) to ensure that appropriate technical personnel review QAPPs and QMPs prepared by PRPs, Contractors and USACE. ERRD is also responsible for assuring that data from the regulated community and other outside sources are appropriate for use by the Agency.

Office of Policy and Management (OPM)

The Office (similar to a Division) consists of the Assistant Regional Administrator (ARA), who serves as Director, two Deputy Division Directors, the Equal Employment Opportunity Officer, the Senior Information Officer and six branches, all of whom report to the ARA. The Office is responsible for all of the Region's policy and administrative activities, including management, policy making and coordination, cross-divisional coordination, resource management, and coordination of lead region functions. Project Officers have the responsibilities described in the Project Officer's Section. Each division is also responsible for assuring that data from the regulated community and other outside sources are appropriate for use by the Agency.

The Office's Policy, Planning and Evaluation Branch provides policy and program coordination, integrated planning and budgeting, grants administration, contracts management, audit management, financial management, information systems, human resources management, equal employment opportunity, total quality and customer service coordination, health and safety and facilities management. This branch also houses the Region's main Geographical Information System (GIS) activities and has the responsibility for ensuring that appropriate QA measures are applied to projects they manage or are involved in.

In addition, the Grants and Contracts Management Branch (GCMB) is responsible for confirming that grants involving environmental information are appropriately entered and tracked through IGMS. GSMB is responsible for ensuring the use of the QAR form for contracts. The GCMB is also responsible for including appropriate QA policy and practice information in the training it provides concerning grants, contracts, and interagency agreements

Finally, the Information Systems Branch is responsible for ensuring that computing and communication hardware and software used by the Region are the subject of appropriate QA oversight.

The Senior Information Officer (SIO) is responsible for providing leadership, coordination and advice on Information Technology and Information Management issues facing the Region. The SIO serves as a central point of accountability on information technology and management matters for the Region. He also serves as the Region's representative on the Quality Information Council (QIC), an Agency-wide council, to address enterprise-wide issues and to develop Agency policies to guide EPA decision makers in the area of information technology/information management.

Office of Regional Counsel (ORC)

This Office (similar to a Division) is headed by the Regional Counsel, who serves as this office's Director, supported by a Deputy Regional Counsel, two Associate Regional Counsels, and five branches, all of whom report to the Regional Counsel. ORC is concerned with the development, implementation and coordination of all Regional legal activities. This Office very rarely is responsible for any programs or projects that involve environmental information except for requirements that its staff might include in enforcement actions. In those cases, ORC staff will usually utilize DECA staff to serve as the Project Manager, responsible for ensuring the application of the appropriate QA controls.

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1.B.3. QA Approval Authority

As described in Subsection 2.B.4, Table 2a, 2b and 3, Region 2 has designated individuals to review and approve QMPs, QAPPs and other documents, either through formal or informal delegation. If at any time question of signatory authority arises, the question should be raised to the RQAM, the Hazardous Waste Support Section Chief, and/or the Air and Water QA Team Leader.

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1.B.4. Resources to Support the Quality System

The RA allocates resources based on OPM's and Division Director recommendations. The DESA Division Director, based on recommendations from the RQAM and the QAOs through their Branch Chiefs, allocates funds for all intramural, extramural, training, and travel funds on an annual basis, or when emergencies arise. If the RQAM does not believe these allocations to be adequate, the RQAM may raise the issue with the DRA.

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1.B.5. Lines of QA Communication

Communication about QA matters flows freely and routinely between the RQAM and the QAOs, particularly among the RQAM and the Hazardous Waste Support Section Chief, the Air and Water QA Team Leader, and the Laboratory QAO. Specific QA responsibilities of the RQAM and the Regional Quality Assurance Officers (QAOs), who are located in three Branches within DESA, are shown in Table 1. To foster communication and to promote broad discussion of current QA issues, the RQAM schedules quarterly meetings with the combined QA staff from MAB, HWSB and LAB. In addition, communication on specific agenda topics takes place among the RQAM and the QAOs with Headquarters and QA staff in other Regions during the monthly RQAM calls. The QAOs also have free and routine exchanges within their groups and with those in the Region with whom they have program or project related dealings. During the annual work planning meetings in the fall, the degree of communication between the QA Staff and program personnel increases. The RQAM and QAOs communicate with others, as appropriate, when issues arise or questions are raised. On project-specific QA matters, communication is normally between the QAO and the Project Officer and not directly with the grantee or contractor.

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Section 2: PLANNING

We have used the acronym "PIE" to describe Region 2 Quality System functions. The "P" stands for Planning, the "I" for Implementation and the "E" for Evaluation. Each of these main parts of our quality system are described within this QMP. Planning is described here in Section 2. Implementation is described in Section 3 and Evaluation in Section 4.

PIE graphic
Figure 1. The Quality System PIE

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2.A. Management of Systematic Planning

2.A.1. The Graded Approach

Quality Glossary - A listing of QA related terms and their definitions can be found at www.epa.gov/quality/glossary.htm

In the Region 2 Quality System, we apply the Graded Approach across all programs and projects. Highly complex, costly, priority programs and projects are expected to be more detailed in their planning and implementation of quality policies and principles, while those at the other extreme are expected to apply those policies and principles in a manner that fits their circumstances.

Region 2's graded approach is determined on a case by case basis.

EPA's QA Order 5360.1 (available at www.epa.gov/quality/qs-docs/5360-1.pdf) and supporting documents encourage the use of the graded approach for QA of environmental data collection/use activities. This approach leads to a logical level of QA/QC activities and documentation for each type of environmental data collection activity performed. Headquarters (HQ) Quality Staff leaves each Region to apply the graded approach building in flexibility, depending on the needs of the program and/or project.

At the project level, the most common example of a project that may require a lesser level of detail is a QAPP being developed for an inexpensive project being conducted by a small organization or for a project collecting screening level data. However, if the results of the project are likely to be controversial or very influential in future actions, are confirmatory in nature, and/or may be used for risk assessments or litigation purposes, more detailed documentation is required in a QAPP. Just because the organization is small does not necessarily mean that the impact of its work will be insignificant.

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2.A.2. Systematic Planning in the Region

At the start of each Fiscal Year, DESA meets with DECA, DEPP, and ERRD to identify that year's priorities in the context of Regional resources , regulatory requirements and national and regional EPA goals. Every attempt is made through this iterative process to coordinate the collection and use of environmental data with other federal, state, tribal and local governmental agencies, volunteer monitoring organizations and academic institutions. To this end, participation in cross-organizational planning groups is encouraged. This process results in formal and informal interdivisional Work Plans, specifying the types of activities that will be conducted that year, and quantifying those activities in detailed work plans. This systematic planning process also involves routine contacts throughout the year for "mid-course corrections," if needed.

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2.B. Systematic Planning for Environmental Information Projects (EIP)

It is Agency and Regional Policy that Systematic Planning be used for all environmental information projects.

2.B.1. Systematic Planning Process

Region 2 Policy

Decision-makers/data users must use a systematic planning process as a mechanism for balancing conflicting demands and data quality needs to ensure that environmental monitoring will effectively support decision making.

It is Regional policy that decision-makers/data users use a systematic planning process (SPP) as a mechanism for balancing conflicting demands and data quality needs to ensure that environmental monitoring will effectively support decision making. Regional managers make decisions based on information provided by their staff, technical advisory committees and by regulatory requirements. QA staff should be involved in all planning sessions, such as scoping and technical meetings. The process focuses attention on the relationship between data quality and the likely effectiveness of the final decision that will be based on the data. This allows the decision maker to balance the concrete costs of monitoring against the less tangible costs, or risks, of making a decision based on uncertain data.

For individual projects, development of the QAPP is the practical application of the systematic planning process. The QAPP itself is then the product and documentation of the systematic planning process.

The SPP clarifies project technical and quality objectives, defines the appropriate type of data, and specifies tolerable levels of uncertainty that will be used as the basis for establishing the quality and quantity of data needed to support decisions. Development of performance acceptance criteria must be a part of the SPP, and be accomplished based on cost-effectiveness and realistic capabilities of the measurement process.

The underlying concept of the Systematic Planning Process is that the project manager is responsible for the quality of the project, and is responsible for ensuring that the project is planned from the start with the clear goal of achieving its intended purpose. The Region's QA Staff are available to assist, and will fulfill the responsibilities described for them in section 1.B.2. of this QMP, but the project manager carries ultimate responsibility from the beginning to the end.

The Agency's combined Data Quality Objectives/Data Quality Assessment (DQO/DQA) Processes (discussed in Subsection 2.B.5.)are recommended tools for applying the Systematic Planning Process to specific projects to ensure that the decision-makers will fully understand the balance between the risks of making an incorrect decision based on the results of the project and the costs in conducting the project. They are followed, at least to some degree, for many Superfund projects. However, the DQO/DQA process is not necessary or appropriate for many Region 2 projects. Instead, the essential elements of their iterative development process are utilized via the graded approach (see Subsection 2.B.2. for document citations and see Subsection 2.A.1. for the Graded Approach).

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2.B.2. The Quality Assurance Project Plan (QAPP): the Product of Systematic Planning

The primary tool that is available for use by the PM/PO/COR for fulfilling their overall responsibility for the quality of their projects is the Quality Assurance Project Plan (QAPP). It is Region 2 policy that a QAPP is required to be developed and signed prior to the generation or use of environmental data in any project conducted by or for the Region. Preparation of the QAPP ensures thorough development and documentation of the Systematic Planning Process because it leads the PM/PO/COR and the technical staff (whether in-house, grantees, contractors, or others) in a step by step process from conceptualization of the project all the way through the eventual data usability assessment.

Regional Policy

Use of a Quality Assurance Project Plan (QAPP) ensures thorough development and documentation of the Systematic Planning Process. No data collection activities or use can begin until there is an approved QAPP.

For individual projects, development of the QAPP is the practical application of the systematic planning process. The QAPP itself is then the product and documentation of the systematic planning process.

The first step for the PM/PO/COR is to ensure that those actually planning the project utilize the QAPP as a guide and as a mechanism for documenting their planning process. This is often accomplished at a Scoping Meeting among the project managers, QAO and other appropriate stakeholders. Arguably the most important elements in the QAPP are the statement of the objectives of the project as a whole, followed by the data needs and the data quality needs to achieve those objectives, along with assurance that suitable and sufficient resources will be available for completing the project. Normally, the QAPP contains quantitative measures of the quantity and quality of the data that will need to be collected, often called Measurement Quality Objectives (MQOs). For some projects, project managers will be able to utilize EPA's Data Quality Objectives (DQO) Process to arrive at its DQOs for the project. DQOs have been found to be a very effective and efficient process when applicable (please see G-4 for details at www.epa.gov/quality/qs-docs/g4-final.pdf).

QA Note - For stack emission tests, the QAPP is called a Stack Test Protocol

A number of valuable guidance documents related to systematic planning and QAPP development are available on the EPA Headquarters Quality web site, at www.epa.gov/quality/qa_docs.html and at www.epa.gov/fedfac/documents/qualityassurance.htm.

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2.B.3. When is a Quality Assurance Project Plan (QAPP) Required?

A QAPP is a required planning document for all projects that involve the generation and/or use of environmental information - generally thought of as environmental data. These environmental information projects are mostly traditional sampling and analysis projects. However, many other types of work are considered environmental information projects and require QAPPs.

It is Region 2 policy that no data collection or use activities may begin until there is an approved QAPP in place.

Some projects requiring QAPPs include:
Sampling and analysis
The use of data collected for some other uses, called the Secondary Use of Environmental Data (see section 2.B.3.a. for more)
The development and/or use of models of environmental processes, such as air pollution models, models used for TMDL development, or land use models
The use of Geographic Information Systems (GIS), usually beyond the use of GIS to produce routine presentation maps not involved in decision-making
Questionnaires of human activities
Surveys (e.g. Emergency Room admissions for asthma or mass transit use)
Studies of flora and/or fauna prevalence or trends
Research into methods or procedures

For regulatory work Region 2 staff are strongly encouraged to include QA requirements as part of their enforcement instruments.

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2.B.3.a. Secondary Use of Data Projects

Very often PMs/POs/CORs want to use some data or other information that already exists, or is being collected at the same time, but in a different project, i.e. secondary use of data. PMs/POs/CORs need to take special care in their Secondary Use of external data to ensure that they don't compromise their own project, while still taking advantage of someone else's hard work - and expense. Sometimes, the external data are simply the only way that such information could be gathered, such as trend data on contamination of a harbor over the last 10 years. There is no way that PMs/POs/CORs could go back in time and collect those data.

Secondary Use of Data requires the development of a QAPP, or needs to be included in a QAPP for a project that includes other data generation or use as well. The only exception is if you can verify that the data were generated for the same purpose for which you will use them. The various guidance documents explain how to treat the Secondary Use of Data in your QAPP, and in your project (Section 9 of regional QAPP guidance at www.epa.gov/region02/qa/qa_documents/air_h20_qapp04.pdf and in the UFP QAPP Guidance - Subsection 2.7 at www.epa.gov/fedfac/pdf/ufp_qapp_v1_0305.pdf page 74).

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2.B.3.b. Modeling Projects

There are a number of different types of projects that utilize models (mathematical algorithms for inferring/predicting an environmental condition). Some projects involve the development or modification of a model to address a specific question. Others involve the use of existing models. Some of these modeling projects utilize only existing data, while others utilize only new data collected as part of the same project, or a combination of old and new data. In general modeling projects need to be covered by a QAPP, however the QAPP may not necessarily need to be developed for the specific project at hand. There are a number of guidance documents available (i.e. G-5M www.epa.gov/quality/qs-docs/g5m-final.pdf and the November 2003 Council for Regulatory Environmental Monitoring [CREM] "Draft Guidance on the Development, Evaluation, and Application of Regulatory Environmental Models" found at http://cfpub.epa.gov/crem/cremlib.cfm#whitepapers) that provide assistance in determining whether a new QAPP is needed, and if so, how it should be developed. Anyone contemplating beginning a new modeling project should consult with a member of the QA Staff.

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2.B.3.c. GIS Projects

There are a number of different types of projects that utilize Geographic Information Systems (GIS, a collection of computer hardware, software, and geographic data designed to capture, store, update, manipulate, analyze, and display geographically referenced data). Some projects involve the development of new techniques and/or underlying spatial data to answer a specific question. Some of these GIS projects utilize only existing data, while others utilize only new data collected as part of the same project, or a combination of old and new data. In general projects that simply involve use of existing data and established procedures do not require a QAPP. Projects that involve field collection of new spatial data or development of new procedures to support environmental decisions generally should be covered by a QAPP. Refer to "EPA Guidance for Geospatial-related Quality Assurance Projects Plans" found at http://www.epa.gov/esd/gqc/pdf/g5g-final.pdf for guidance in determining whether a new QAPP is needed, and if so, how it should be developed. Anyone starting a new GIS project should consult with a member of the QA Staff or the Region 2 GIS Team (r2gisdata@epa.gov).

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2.B.4. Guidance for QAPP Development, Submittal, Review and Approval

Regional Policy

No data collection activities or use can begin until there is an approved QAPP.

The Region's QA Staff have implemented a number of simple steps to facilitate the development, submittal, review, approval and tracking of QAPPs. In order to accommodate the needs and constraints of the various programs, these steps are segregated by program: Superfund, RCRA and Brownfields; Emergency Response; Stack Emission Tests; all other Programs. The procedures for QAPP Development, Submittal, Review and Approval are described in Subsections 2.B.4.a, b, and c, respectively.

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2.B.4.a. QAPP Development

The PM/PO/COR responsible for submitting a QAPP should enlist the assistance of others involved in the project to write, provide input, and/or review the QAPP, but retains ultimate authority for ensuring the implementation of an EPA approved QAPP. The PM/PO/COR is encouraged to include all organizations that will be involved in the project to participate in planning scoping meetings. The PM/PO/COR should encourage all parties to sign the QAPP both to ensure that their interests are appropriately accounted for and to verify their acceptance of the responsibilities described in the QAPP. The QAO responsible for approving the QAPP should not write the QAPP but is encouraged to participate in general scoping meetings and to offer advice when asked. The PM/PO/COR is responsible for ensuring that no data collection or use begins until the QAPP is approved. Generally, 30 days are recommended for review of a QAPP.

To ensure their effectiveness, QAPPs should be prepared according to an established EPA guidance. Guidance for Quality Assurance Project Plans (QA/G-5), available on the Headquarters Quality Staff web site www.epa.gov/quality/qa_docs.html is the underlying primary reference for all projects. However, depending on the project and circumstances, several guidance documents based on it are required or strongly recommended for projects in Region 2, as described below.

For Superfund, RCRA, and Brownfields projects, it is Region 2 policy that QAPPs be prepared in accordance with the Uniform Federal Policy (UFP) requirements, which are contained in the UFP QAPP Manual and its associated Compendium and Worksheets (www.epa.gov/fedfac/documents/qualityassurance.htm). The Policy was developed as a joint initiative between the USEPA, DOD and DOE for use on all federal facility hazardous waste projects. In Region 2, the UFP has been adopted for all Superfund, RCRA, and Brownfields projects, as it is consistent with the EPA's existing QAPP guidance (QA/G-5). Use of the UFP is compliant with the Quality System requirements of ANSI/ASQ E4 and also ensures the quality, objectivity, utility and integrity of environmental information that the federal government disseminates per the Information Quality Guidelines.

For Emergency Response Projects, special treatment is required, largely because there is often little to no time to plan the environmental data activities from scratch. To accommodate this need, ERRD has applied the graded approach (see Subsection 2.A.1.) to develop a three phase process for implementing the Systematic Planning Process and developing appropriate QAPPs.

Emergency Response activities are time-critical and mostly short term and are sometimes followed by longer term monitoring and assessment, as we experienced in all of the incidents of National Significance to date. The Region's policy must fully support the data collection needs of these projects, while providing the flexibility needed as a project evolves from an initial response to a more mature response. Equally important is the need for appropriate QA planning and documentation for emergency response environmental data collection activities. To meet both requirements, the graded approach is essential to the program and data quality needs.

In emergency situations there is not sufficient time (or information) to develop Quality Assurance Project Plans (QAPP) satisfying all of the EPA Regional and HQ requirements and guidance. QAPP requirements for the emergency response should be streamlined to suit the environmental data collection activities being performed, as well as the situation taking place. For this reason, Region 2 implements QA/QC policies and procedures through the graded approach for Emergency Response environmental data collection activities using three phases. Each phase is defined by the status of the situation, the degree of time criticality, immediate life threats, the potential for follow-up monitoring and the potential for long term monitoring.

Phase 1 - Emergency Response Monitoring
Phase 2 - Transitional or Follow-up Monitoring
Phase 3 - Long Term Monitoring

During emergency or disaster responses QA staff may be utilized within the Incident Command System under the Environmental Unit. This allows QA staff to be available on site or by phone during an emergency should any support be required by the Incident Management Team or Operations staff. QA staff can provide guidance and assistance on the completion of any QA documentation, application of QA principles during implementation, and data review.

For stack emission tests, the QAPP is called a Stack Test Protocol.

For other Region 2 projects, the "Guidance for the Development of Quality Assurance Project Plans for Environmental Monitoring Projects," April 2004 or successor, located at www.epa.gov/region02/qa/qa_documents/air_h20_qapp04.pdf should be utilized. For projects involving the secondary use of existing data, modeling projects, GIS projects, research projects, or other specific work for which the recommended guidance does not seem appropriate, the PM/PO/COR is encouraged to consult with a QAO in the Air and Water QA Team. The National Risk Management Research Laboratory (NRMRL) has guidance applicable for applied and basic research projects.

When a group or continuum of monitoring projects is to be carried out for the same purpose and with the same personnel and procedures, a "generic" plan may be developed. Otherwise, a QAPP must be prepared and approved separately for each project.

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2.B.4.b. QAPP Submittal

To facilitate the tracking and review of QAPPs, the Region's QA Staff have implemented a number of simple steps for submitting a QAPP for review. They are described below:

Superfund and RCRA QAPPs should be submitted to the Hazardous Waste Support Section Chief for review. Brownfields QAPPs are to be submitted to the Superfund Support Team for review.

Emergency Response QAPPs will be submitted to and approved by the Incident Management Team (IMT).

For stack emission tests, the Protocols must be sent to the Chief of the Air Compliance Branch for preliminary review and forwarded to the Air and Water QA Team.

For projects involving the secondary use of existing data, modeling projects, GIS projects or other specific work for which the recommended guidance does not seem appropriate, the POs are encouraged to consult with a QAO in the Air and Water QA Team. A QAPP is to be submitted directly to the PO who will screen the QAPP to ensure that it is complete and that it satisfies the Region's programmatic needs. The PO then submits the QAPP to the Air and Water QA Team Leader, along with a QAPP Review Request Form, which is available on the Region's web site at www.epa.gov/region02/qa/documents.htm.

For all other projects, the QAPP is to be submitted directly to the PO who will screen the QAPP to ensure that it is complete and that it satisfies the Region's programmatic needs. The PO then submits the QAPP to the Air and Water QA Team Leader, along with a completed QAPP Review Request Form, which is available on the Region's web site at www.epa.gov/region02/qa/documents.htm.

See Table 2a and Table 2b for additional information.

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2.B.4.c. QAPP Review and Approval

The Region's QAPP review processes are delineated in SOPs and are available from the RQAM upon request.

The responsibility for submitting and approving a QAPP is shown in Tables 2a and 2b. For some organizations EPA has delegated QAPP approval authority to the organization itself, as is demonstrated in Table 3. The Program variations are as follows:

  • For Water Programs, this information is contained in Table 3. The designated EPA QAO retains the QAPP approval authority for those organizations that are not delegated self-approval authority.
  • For Superfund, regional Contractor PMs submit the QAPP through the Region 2 PM/PO/COR. This PM/PO/COR is responsible for submitting the QAPP to the Region 2 QAO (and other regional technical reviewers as appropriate) for review. The QAO recommendations are given to the Regional PM/PO/COR who approves the QAPP. For PRP lead sites, the QAPP is submitted, reviewed and approved in the same manner. In some instances, the Regional PM engages a regional contractor to perform review of the QAPP, but approval authority remains with the Regional PM.
  • For Brownfields projects, QAPPs are prepared and submitted by the Grantee to the Regional Brownfields PM/PO/COR. This PM/PO/COR is responsible for submitting the QAPP to the Region 2 QAO (and other regional technical reviewers as appropriate) for review. The QAO recommendations are given to the Regional PM/PO/COR who approves the QAPP along with the Grantee.
  • and for RCRA projects, QAPPs are prepared and submitted by the permitted facilities to the RCRA PM. The PM is responsible for review of the QAPP using either an EPA contractor or the Hazardous Waste Support Branch. The PM approves the QAPP, based upon the recommendations of the reviewers.
  • If the EPA PM/PO/COR determines that EPA QAO approval is needed, even though the grantee has been delegated approval authority, a grant condition or other explicit direction must be incorporated indicating this requirement. Also, the EPA PO/COR/PM is responsible for ensuring that any other organizations (such as the Army Corps or Engineers) significantly involved in the project that should review and approve the QAPP do so.

In cases not described below, or if there is any doubt about the proper protocol for a specific project, either the RQAM, the Air and Water QA Team Leader, or the Hazardous Waste Support Section Chief should be consulted.

Table 2a. Routine QAPP Roles and Responsibilities
Organization Submitting QAPP Individual Submitting the QAPP Individual Approving the QAPP
EPA Region 2 Region 2 PM Region 2 QAO
Region 2 Grantee
(except as indicated in Table 3)
Grantee PM/QAO through the Region 2 PO Grantee PM and Grantee QAO then Region 2 PO and QAO
Region 2 Contractor Contractor PM through the Region 2 PM/COR Contractor PM and QAO then Region 2 PM/COR and QAO
Federal Agency Agency project manager through Region 2 PO/PM Agency QAO, then Region 2 PO/PM and QAO


Table 2b. Routine QAPP Roles and Responsibilities for Superfund and Brownfields
Organization Individual Submitting the QAPP Individual Reviewing the QAPP Individual Approving the QAPP
EPA Region 2 staff Region 2 PM Region 2 QAO Region 2 QAO and PM
Region 2 Contractor Contractor PM through the Region 2 PM/PO/COR Region 2 QAO Contractor PM and QAO then Region 2 PM with Region 2 QAO recommendation
Region 2 PRP PRP PM through the Region 2 PM Region 2 QAO or EPA contractor Region 2 PM
Federal Agency (i.e. USACE under IAG) Fed. Agency PM through Region 2 PO/PM Region 2 QAO Fed. Agency QAO then Region 2 PM with Region 2 QAO recommendation
Region 2 Brownfields (Grantee) Grantee PM through the Region 2 PM/PO/COR Region 2 QAO Grantee PM and Region 2 PM/PO/COR with Region 2 QAO recommendation
Region 2 State (Grantee) State PM/QAO State PM/COR or QAO State PM/COR or QAO
RCRA permitted facility RCRA permitted facility through Region 2 PM/COR EPA contractor or Region 2 QAO Region 2 PM/COR


Table 3. Routine Water Program QAPP Approval Delegations
EPA QAO Contact is Air and Water QA Team
Organization Authority to Self-Approve QAPPs
PREQB Water Quality Area No
PREQB Monitoring and Sampling Division No
Interstate Environmental Commission (IEC) No
Haudenosaunee Environmental Task Force No
Seneca Nation of Indians No
St. Regis Mohawk Tribe No
NJDEP Yes
NYSDEC Division of Water Yes
NYSDOH PWSS Program Yes
NYSDOH Wadsworth Yes
NYSDOH Beach Program No
PR Dept. of Ag No
PRDOH PWSS Program Yes
VIDPNR-Division of Env. Protection Yes

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2.B.4.d. QAPP Use During Projects

Important Note

A QAPP is not just a paper document. It is a dynamic tool to be utilized in the field by project personnel.

The QAPP is not simply a paper document, it is a dynamic tool to be utilized in the field by project personnel. If the PM/PO/COR believes that due to time constraints some work on the project needs to and may begin before the QAPP receives final approval, the PM/PO/COR should contact the QAO and request consideration of granting conditional approval, which may be granted in rare circumstances.

If anything goes wrong during implementation, figure out the best course of action, reach an agreement, document the changes, attach them to the QAPP, and distribute the changes to everyone involved in the project!!

After the QAPP is approved and work has begun, if the PM/PO/COR and/or QAO determine that changes to the approved processes are needed, they must follow the corrective action procedures outlined in the approved QAPP. Revised QAPPs generally take less review time. If the corrective actions are approved, they must be documented with the QAPP and sent to the original distribution list in the QAPP. The QAPPs for long term projects should be reviewed annually by the PM/PO/COR to ensure that no significant changes have been made to the project and rewritten every five years. Annual reviews must be documented.

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2.B.5. Systematic Approach for Assessing Data

Once data resulting from the implementation of the approved QAPP are available, they must be evaluated. This process is described in detail in the QAPP. The two most frequently used systematic processes are Data Quality Assessment (DQA) and Data Usability Assessment (DUA).

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2.B.5.a. Data Quality Assessment

Data Quality Assessment (DQA) is the scientific and statistical evaluation of environmental data to determine if they meet the planning objectives of the project, and thus are of the right type, quality, and quantity to support their intended use. This formalized approach is encouraged but rarely used in Region 2. Project Managers who select to use the formal DQO process and subsequent statistical approach to determine whether the data collected meet project objectives should refer to Data Quality Assessment: A Reviewer's Guide (QA/G-9R) and Data Quality Assessment: Statistical Tools for Practitioners (QA/G-9S), both available at http://www.epa.gov/quality1/qa_docs.html. The PM/PO/COR must ensure that this information is specifically discussed in the QAPP.

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2.B.5.b. Data Usability Assessment

As described in detail in Subsection 2.B.1 and 2.B.2. on QAPP development, the Region routinely utilizes a non-statistical approach to project planning under the umbrella of Systematic Planning. When this approach is used, an appropriate tool for assessing the success of the project is the Data Usability Assessment (DUA) checklist. It is the responsibility of the PM/PO/COR to ensure that a Data Usability Assessment (DUA) is used to evaluate the project data, mostly at the completion of the project. This evaluation is required to determine whether the data are adequate for their intended use. DUAs are to be documented and filed with final project report documentation: PMs/POs/CORs should consult with the QAO supporting their programs and projects. The PM/PO/COR must ensure that this information is specifically discussed in the QAPP.

For most projects, data usability is based upon the QA parameters defined in the QAPP, which have been determined by the project planning team. The results of the data validation process are used to determine whether the data are usable for the stated goals of the project. Normally, analytical results that are not rejected during data validation are used for project decisions. However, it is important that each data generation QAPP include provisions for incorporating qualitative input from the field (sampling) components in the project's DUA. This ensures that any important environmental or sampling anomalies, deviations, or variabilities will be considered before the resulting data are used.

In addition, DUAs are conducted by program offices, often under different names. The Ambient Air Quality program, for example, reviews all of the data submitted by the states and, based on the review, certifies the data for entry into the national data base. The review follows very strict and detailed rules, specified in the regulations.

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2.B.6. Standard Operating Procedures

SOPs are used to document routine or repetitive administrative and technical activities. They are considered an integral part of the QA system and are viewed as extensions both of Region 2's QMP and Project QAPPs. They promote consistency within the programs, reducing work effort and improving data comparability, credibility and defensibility.

SOPs should be clearly written and detailed (such as a "cookbook"). They should be maintained in document control and kept current. SOPs must be signed by the preparer and the approving supervisor. They should be reviewed annually to ensure that they reflect current procedures and be updated when necessary. This review should be documented. SOPs documenting internal EPA processes should be maintained within each Division.

SOPs must be readily available to all personnel who need them and implemented as written. Modifications should be documented and have written supervisory concurrence.

SOPs should be reviewed annually to ensure that they reflect current procedures.

When an SOP covers a data generation or use operation that is covered by a QAPP, the SOP should be part of the QAPP by direct attachment or by reference when it is otherwise available. Any modifications to the SOP that occur during the project must be detailed in an addendum to the QAPP. All data collection and use operations, not covered explicitly in an SOP must be in an approved QAPP.

DESA has an SOP for documenting its SOPs that is available for use by anyone else in the Region developing SOPs, whether related to environmental data or not. DESA's QA-related SOPs to be used by internal and external parties, including the SOP for SOPs, may be found at: www.epa.gov/region02/qa/documents.htm.

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2.C. Planning QA for Extramural Agreements

The Region is responsible for ensuring that its contractors, grantees, and other partners have and implement Quality Systems of their own that will be sufficient to ensure that their environmental data operations fulfill the Region's needs.

For larger organizations, this means that they must develop and implement Quality Management Plans of their own, demonstrating their organization's commitment to quality, describing their organizational roles and responsibilities, and their internal systematic planning process. The RQAM, in consultation with the QAOs and regional program managers, will determine which organizations shall be required to submit QMPs. The Region's policy, in conformance with EPA QA-R2, (www.epa.gov/quality1/qs-docs/r2-final.pdf), is that all submitted QMPs must conform to QA-R2 and the Uniform Federal Policy for Implementing Environmental Quality Systems (UFP-QS). QMPs may be approved for up to 5 years, at the discretion of the RQAM in consultation with Region 2 QAOs and the organization submitting the QMP. They need to be reviewed annually by the organization's QAO and reported to the RQAM, who tracks the process. QMPs may be updated more often if significant changes take place in the organization or its programs. The QMPs will be signed and tracked by the RQAM.

Larger organizations and others as determined by the RQAM and the QAOs, will be required by their QMP or work plan to submit annual QA reports and work plans. These documents will indicate the status of the organizations' QA programs, their accomplishments and needs.

2.D. Information Quality Guidelines

EPA's Information Quality Guidelines (IQGs) contain EPA's policy and procedural guidance for ensuring and maximizing the quality of information the Agency disseminates. They are interrelated to the Regional Quality System for assuring the quality of EPA's data products and information. "Information" generally includes any communication or representation of knowledge or position/policy such as facts or data in any medium or form. This includes "preliminary" information that EPA has endorsed or adopted and also conclusions or facts drawn from or based upon other existing information. This QMP incorporates by reference all definitions, principles, policies and procedures found in EPA's IQGs (http://www.epa.gov/quality/informationguidelines).

2.D.1. Implementation Policy and Procedures

Region 2 will comply fully with EPA's IQGs and where needed will establish policies and procedures for complying with these guidelines. Emphasis will be on using existing Regional processes and procedures wherever possible to comply with the requirements of the IQGs. The review process is intended to ensure the quality of the Region's information disseminations and is incorporated into the QAPP review processes of each Divisional QMP. The Region 2 Information Quality Guidelines Officer assumes responsibility for coordination of the IQG process in Region 2 with the Office of Environmental Information.

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2.D.2. Request for Correction (RFC)

The Information Quality Guidelines (IQGs) allow for affected persons to request correction of information if that information does not comply with the IQGs. The Office of Environmental Information will receive these complaints and forward them to the Region 2 IQG Officer when the information in question belongs to or involves Region 2. Upon receipt of the request for correction from the OEI, the IQG Officer will notify the responsible Programmatic Division(s).

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2.D.3. Request for Reconsideration (RFR)

The IQGs allow for affected persons to request a reconsideration of EPA's decision on a request for correction of information if they are dissatisfied with the decision. The Office of Environmental Information will receive these complaints and forward them to the Region 2 IQG Officer when the information in question belongs to or involves Region 2. Upon receipt of the request for reconsideration from OEI, the IQG Officer will notify the responsible Programmatic Division(s).

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2.D.4. Predissemination Review

Subsection 7.1 of EPA's Information Quality Guidelines require that each organization (Region 2 in this case) implement procedures to assure that information is reviewed before it is disseminated and has developed Pre-Dissemination Review Guidelines (PDRGs) (pdfs/pdr-guidelines.pdf) Region 2 is in the process of developing a process for PDRG and when it is finalized it will be added to this QMP.

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Section 3: IMPLEMENTATION

We have used the acronym "PIE" to describe our quality system here in Region 2. The "P" stands for Planning, the "I" for Implementation and the "E" for Evaluation. Each of these main parts of our quality system are described within this QMP. Planning is described in Section 2. Implementation is described here in Section 3 and Evaluation in Section 4.

PIE graphic

The Planning step is the most important part of the Region's Quality System, but the Implementation part is the largest, most active part, with the shortest description. The complete description of the management of the implementation of the Quality System is: Implement the Plans as described in Table 4 below, measure their performance (See Section 4, Evaluation), and document any deviations.

Table 4. Quality System Implementation Activities
Program Level Activities
Quality System Activity Planning (P) Implementation (I) Evaluation (E) Link to Section in this QMP
QMP Regional QA Staff Regional Employees OEI Quality Staff n/a
QA Training Regional QA Staff Regional QA Staff Participants Subsection 5.B.1.
QAARWP Regional QA Staff n/a OEI Quality Staff Subsection 4.A.1.
Interdivisional Workplans DESA and Other Divisions DESA via DESA Management Accountability System (MAS)  
Assessment of Region's Quality System OEI Quality Staff and Region 2 QA Staff OEI Quality Staff and Region 2 QA Staff Regional Management Subsection 4.B.1.
Project Level Activities
QAPPs See Tables 2a, 2b and 3 See Tables 2a, 2b and 3 See Tables 2a, 2b and 3 See Tables 2a, 2b and 3
Quality System Assessments Regional QA Staff Regional QA Staff Audited Entity Subsection 4.A.3.a.
Performance Test Audit (or PT Sample) Regional QA Staff Audited Entity Regional QA Staff Subsection 4.A.3.c.
Data Usability Assessment PM/PO/COR PM/PO/COR n/a Subsection 2.B.5.b.
Internal Assessment (IA) Regional QA Staff Regional QA Staff Program Management Subsection 4.B.2.

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Section 4: EVALUATION

We have used the acronym "PIE" to describe our quality system here in Region 2. The "P" stands for planning, the "I" for implementation and the "E" for evaluation. Each of these main parts of our quality system are described within this QMP. Planning is described in Part 2. Implementation is described in Part 3 and Evaluation here in Part 4.

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4.A. Evaluation by the Region

Region 2 uses the terms evaluate, assess, and audit interchangeably.

This section of the QMP deals with the "Evaluation" step in the process. Region 2 uses the terms evaluate, assess and audit, interchangeably. An audit is simply a check to determine whether you did what you said you were going to do. This section also describes what we do when an audit reveals the need to take corrective action. However, before we get to the various types of audits that the Region utilizes, two points need to be clarified: who and what are we auditing, and whether it is all done formally.

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4.A.1. Annual Region 2 Management Review

Quality Glossary - A listing of QA related terms and their definitions can be found at www.epa.gov/quality/glossary.htm.

Region 2 QA staff perform an annual review of the Region's Quality System. The results of this assessment are documented in the Quality Assurance Annual Report and Work Plan (QAARWP). The QAARWP is submitted to Headquarters OEI Quality Staff. In preparing the QAARWP response, the Region's QA Staff performs informal but sometimes quantitative assessments of the accomplishments, issues, and status of the Quality System. The QAARWP is signed by the Regional Administrator and serves as a tool for ensuring dialog between the QA Staff and regional management on the state of the Region's Quality System.

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4.A.2. What Does the Region Evaluate?

The Region uses a variety of evaluation tools (See Subsection 4.A.3.) to assess the components of the Quality Systems for which it has oversight responsibility. These include: the Region's own Quality System, its environmental data programs and projects, state programs, state laboratories, federally funded projects (internal or external), standard operating procedures, and data used to support EPA programs and projects.

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4.A.3. What are the types of Assessments performed by Region 2 QA Staff?

The Region utilizes a number of different types of assessments for evaluating programs, organizations and activities. The following subections describe the different types of assessments that are carried out as part of the Region's Quality System.

Assessment Type Abbrev. Description
Quality Systems Assessment QSA Checks conformance with the QMP, and determines if it is working. Typically performed on states, tribes and large grantees.
Technical Systems Audit TSA Checks conformance with the QAPP and/or SOP. Typically performed in the lab or the field.
Performance Test Audit (or PT Sample) PTA Assessment of performance on a very specific activity, such as sample analysis.
Data Quality Assessment DQA Assessment of the final results of a project that had been designed using the Data Quality Objectives (DQO) Process (See Subsection 2.B.5.).
Data Usability Assessment DUA Assessment of the actual usability of the data produced by a project that did not use DQO. Less formal than DQA (See Subsection 2.B.5.).

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4.A.3.a. Quality Systems Assessment (QSA)

A Quality Systems Assessment is a formal assessment (or audit) of a program's Quality System. In practical terms, it is an assessment of how well the organization is conforming to its Quality Management Plan (QMP), along with an assessment of the degree to which the Quality System is actually working. In Region 2 we conduct QSAs on our major grantees, namely the States, and occasionally on other organizations or programs. The RQAM maintains a schedule of QSAs that are to be performed with the goal of auditing all major programs in 3-year cycles. To ensure consistency and adequate and appropriate coverage, the Region conducts its QSAs according to a Standard Operating Procedure.

QSAs of major EPA Superfund contractors are scheduled on an annual basis. Priority focus for such reviews is based on problems uncovered during technical system assessment and prior QSA reports.

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4.A.3.b. Technical Systems Assessment (TSA)

A Technical Systems Assessment (TSA) is an audit/review of a technical activity, such as sampling, analysis, or calibration. It is usually project-specific, and is usually conducted in the field or laboratory. Whenever possible, an audit is performed by a team of two or more individuals knowledgeable in the specific activity being audited. Experts can be called upon to assist in a TSA as well, but the EPA QAO is in charge of the review and final determinations.

A TSA compares the way the activity is being conducted in comparison to the way it is supposed to be conducted, as specified in an approved QAPP, SOP, manual, or other documentation.

Grantees with approved QMPs may conduct TSAs of their own operations. In some instances, Region 2 is required by regulations to conduct TSAs of certain grantee operations (i.e., state drinking water analysis laboratories, and state/tribal ambient air quality monitoring networks). EPA remedial contractors and field investigation team contractors are required to conduct TSAs of their own field activities.

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4.A.3.c. Performance Test Audit (PTA)

The Performance Test Audit (PTA), also called a Performance Evaluation (PE) Audit or a PT Sample or PE Sample, is a means for evaluating performance on a specific analytical method, either in the laboratory or in the field. The Region's laboratory operations are subject to a number of PT Audits. For example, the Laboratory Branch participates annually in the Water Pollution (WP) and Water Supply (WS) studies. From time to time, the Region may utilize PT samples to audit targeted analytical operations.

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4.B. Evaluation of Regional Operations

We have used the acronym "PIE" to describe our quality system here in Region 2. The "P" stands for Planning, the "I" for Implementation and the "E" for Evaluation. Each of these main parts of our quality system are described within this QMP. Planning is described in Section 2. Implementation is described in Section 3 and Evaluation here in Section 4.

The following subections describe the internal and external assessments performed on Region 2's Quality System.

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4.B.1. Independent Program-level Assessment

In addition to reviewing and commenting upon the QAARWP, EPA's QS conducts a QSA of the Regional QA program on a triennial basis. Findings requiring corrective action are appropriately addressed in a timely manner. In addition, management systems reviews of program activities are carried out by the appropriate EPA headquarters program staff. For example, the drinking water certification program is reviewed annually either in person or by information requested to be submitted. Independent assessments of delegated program and grantee activities are conducted through jointly conducted TSAs as well as the QSA process, as discussed in Subsections 4.A.3.a. and b.

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4.B.2. Internal Assessment (IA)

Internal Assessments (IAs) are Assessments or audits of Region 2 Environmental Data Operations, QA Activities, and/or related processes that are conducted by Region 2 QA Staff for the purpose of determining whether those activities, operations, or processes are ineffective, inefficient, or in need of improvement. The results of the IA are reported to the organizational unit being assessed, requiring the development and implementation of a corrective action plan. This is further discussed in Subsection 4.C.4., and in Headquarters' "Guidance on Technical Audits and Related Assessments for Environmental Data Operations" (QA/G-7), available at www.epa.gov/quality/qs-docs/g7-final.pdf. DESA managers and the QA staff determine the Internal Audits to be conducted each year and track them as part of the Division's overall work plan output tracking system.

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4.B.3. Technical Independent Assessment

The Regional laboratory participates in and is audited by the NELAP. Other reviews may be conducted by appropriate headquarters personnel. Also, regional participation in annual PT studies assess technical competency. Corrective actions are addressed in a timely manner, as appropriate for the process that identified the finding. In addition the Brownfields Mobile Laboratory and the Ambient Air Standards Lab participate in a variety of Assessment Activities, as specified in their respective QMPs.

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4.B.4. Internal Review

An essential element in the development of QA planning for the next year is a careful review of the past year's activities, accomplishments, and problems. The RQAM and the QA staff conduct this review in conjunction with the divisional work plan planning process to ensure that the plans reflect any identified needs and concerns. At the same time, the relevance of the QMP is reviewed. The QAARWP is submitted to QS for review. Regional peer reviews are conducted on selected projects as determined annually by the peer review work group.

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4.C. Quality Improvement

We have used the acronym "PIE" to describe our quality system here in Region 2. The "P" stands for Planning, the "I" for Implementation and the "E" for Evaluation. Each of these main parts of our quality system is described within this QMP. Planning is described in Section 2. Implementation is described in Section 3 and Evaluation here in Section 4. This subsection of Section 4, Quality Improvement, is the natural second half of Evaluation, because any time we find anything as part of an Evaluation that needs improvement, it is essential that we pursue that improvement. Quality Improvement is an inherent part of the Region's Quality System, and fits well in this QMP as the natural consequence of Evaluation.

The Region 2 QA staff meets regularly to discuss cross-cutting issues and to look at ways of improving the organizational implementation of QA. The Region 2 QA staff also provides a perspective on the continuous improvement process and provides advice and recommendations to program office managers on ways to improve the quality processes within the Region.

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4.C.1. Quality System Improvement Process

It is the responsibility of line management for assuring staff participation for all program reviews and to review annually all QA activities of their staff, e.g., determining that SOPs are in place and revised if necessary, that QAPPs are written and approved in advance of project start-up and that data quality assessments are made. All deviations and discrepancies noted during any independent or self-assessment review will be corrected promptly and modifications made, if necessary, to the Regional QMP. Additionally, the RQAM communicates results of audits, assessments, and reviews with program counterparts to identify areas of excellence, and areas needing corrective actions.

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4.C.2. Corrective Action for Quality-Related Problems

Region 2 SOPs for conducting QSAs and laboratory or field TSAs mandate corrective actions be identified in review or audit reports, when appropriate. The RQAM and QAOs ensure that reports contain warranted corrective actions, and that such corrective actions are, in fact, implemented in the specified timeframe. The results of follow-up on corrective action are documented with the associated reports that initiated the requirement for corrective actions. The QAARWP will reflect progress made in these corrections.

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4.C.3. Creating an Environment for Facilitating and Promoting Quality Improvement in Project Development

It is the responsibility of PM/PO/COR to request project reviews and/or audits and to identify where improvements can be made. This process is started during the scoping meeting initiating the Systematic Planning Process and is finalized during the assessment of data quality in the project final report. All corrective actions and deviations required during the life cycle of the project are to be filed in or with the final report. QAOs are encouraged to attend project meetings and conference calls and to conduct technical audits.

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4.C.4. Corrective Action via Internal Assessments

Region 2 QA Staff and management develop an annual list of Internal Assessments to be conducted that year, based on their experience during the past year, external reports, etc. This is further discussed in Subsection 4.B.2., and in Headquarters' "Guidance on Technical Audits and Related Assessments for Environmental Data Operations (QA/G-7)," available at http://www.epa.gov/quality/qs-docs/g7-final.pdf.

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4.C.5. Continuous Improvement of Products, Services, and Performance

It is the Region's policy that the QA staff and all others associated with the environmental information generation and use programs and projects will strive for continuing improvement in the products and services they provide, and in their performance in doing so. Managers should encourage innovation and improvement and should include it as tangible elements in staff performance reviews and awards. The RQAM and the other QA managers and supervisors should seek and implement processes designed to foster an atmosphere of improvement in the Region's QA community.

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Section 5: INFRASTRUCTURE

5.A. Procurement of Products and Services

This Section documents the procedures for purchasing items and services that directly affect the quality of environmental programs. 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.

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5.A.1. Procurement Planning and Control

Procurement of items must meet established administrative and QA requirements of the agency. In Region 2, OPM is responsible for ensuring that procedures are in place for all procured items and services. Procurement of environmental data services requires suppliers to have a Quality System, consistent with EPA QA requirements.

Quality Glossary - A listing of QA related terms and their definitions can be found at www.epa.gov/quality/glossary.htm.

Request for proposals and other solicitation documents for the Superfund and RCRA programs are reviewed by the Region 2 QAOs to insure that QA requirements are included in the solicitation. All respondents are required to describe their quality system.

In Region 2, part of the process for ensuring conformance with these requirements for contracts is the use of a QA Review (QAR) Form for each procurement request/order, except for incremental funding actions, when the acquisition is in excess of $25,000 and is in one of the following object classifications: Research and Development Contracts, Program Contracts, Occupational Health Monitoring, Occupational Health and Safety Other, Laboratory Supplies, Scientific and Technical Equipment. In addition, the QAR Form must be submitted for procurements valued at less then $25,000 that are for information collected or produced from measurements, analyses or models of:
  1. environmental processes or conditions;
  2. industrial, commercial, or personal processes or conditions of interest because of their relationship to the environment; or,
  3. experimental systems representing any such processes or conditions.

Contractors and suppliers are responsible for the quality of work performed or items and services provided by their subcontractors and suppliers.

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5.A.2. Superfund Procurement Assessment and Verification

Region 2 Superfund QAOs routinely participate in the selection process for procurement of items and services that involve the collection and use of environmental data. Proposals must show that the description of the quality system meets EPA Region 2 requirements.

During the life of the contract, Region 2 QAOs provide oversight of the contractor's products and activities. Region 2 QAOs also participate in the evaluation of the contractor's performance throughout the year. The performance of the contractors' quality system is an integral part of the evaluation process.

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5.B. Personnel Qualifications And Training

The application of sound QA policies and procedures requires that all staff who perform quality-related tasks associated with environmental data operations have an appropriate level of knowledge of QA procedures and principles.

The Region 2 Quality System depends on each individual understanding the program and her or his roles and responsibilities within it, and then carrying them out. This subsection describes the Region's program for ensuring that individuals in the Region associated with environmental data operations receive the training, guidance and experience needed.

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5.B.1. Training

Managers are responsible for ensuring that all personnel (including themselves) involved with environmental data have the necessary knowledge, skills and training, including certifications, for their tasks and functions, and that the EPA Program requirements, where available, are met. The Regional QA Manager (RQAM) and the Regional QA Officers are responsible for determining general and specific QA training needs and for making appropriate training available to managers and their staff. In addition, they are responsible for assisting major grantees (and perhaps others) in providing appropriate QA training for their staff.

The Region has a comprehensive QA training program designed to train all individuals involved with environmental data operations in the basics of QA and of the Region's Quality System. The initial training is an intranet-based on-line course. The website address is available from the RQAM . All new employees involved with environmental data operations are required to take the on-line training. For employees designated by their management, the initial training is followed by program-specific training to groups of individuals in their specific QA roles and responsibilities. Records of employee's QA training are maintained by the RQAM.

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5.B.2. Evaluation of Training Needs

Quality Assurance (QA) training needs for the QA staff are determined on a case by case basis, with the general goal being exposure to current QA thinking and methods along with changing Agency QA directives and policies.

QA training needs for others in the Region 2 community are determined and established by the RQAM and QAOs through their experience and in consultation with regional managers and staff. Training Evaluation Forms are used to revise course content and guide future training developments.

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5.B.3. Access to QA Information

The Region 2 DESA website contains a considerable amount of Region 2 QA material, as well as, links to other useful QA sites (including the extensive HQ QA site www.epa.gov/quality/qa_docs.html). The website containing the Region 2 QA documents and links is located at: www.epa.gov/region02/qa/documents.htm. Employees interested in this material are encouraged to visit that site.

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5.C. Documentation and Records

Each Program Office is the custodian of its own quality-related documents and records pertaining to environmental data operations.

Each Program Office is the custodian of its own quality-related documents and records pertaining to environmental data operations. DESA's QA Records Management Procedures SOP identifies the policies and procedures for implementing DESA's management of quality system documents. This SOP is available from the RQAM on request. All quality system documents are maintained in accordance with EPA's Records Schedules.

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5.D. Computer Hardware and Software

Region 2 adheres to OEI's Information Technology policies, standards, guidance and procedure, where applicable. Region 2's Information Systems Branch (ISB) is responsible for the planning, implementation, support and maintenance of the Region 2's Local Area Network (LAN) and electronic mail using Lotus Notes. ISB manages the Information Center/Help Desk and provides training and support for the Region's PCs and application software. The branch is also responsible for the approval, installation and support of all information technology (IT) related hardware and software. The branch provides database administration support for some major program systems in the region. ISB is responsible for the Region 2 Intranet website and shares responsibility with the Public Affairs Division for the EPA Region 2 public access website.

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Appendices

Appendix A: Organizational Charts


Region 2 Organizational Chart

Region 2 Organizational Chart

Division of Environmental Science and Assessment (DESA) Organizational Chart

DESA Organizational Chart

Appendix B: Acronyms

Click Here or See Acronyms Link in the Left Side Bar



Appendix C: List of Referenced Essential Links


Link Description
www.epa.gov/quality/qs-docs/5360-1.pdf EPA Order 5360.1 A2
www.epa.gov/quality/glossary.htm A listing of QA related terms and their definitions
http://www.epa.gov/quality/informationguidelines Information Quality Guidelines Website
www.epa.gov/region02/science/ Region 2 Science and Technology website
www.epa.gov/fedfac/documents/qualityassurance.htm Uniform Federal Policy for Quality Assurance Project Plans (UFP-QAPP) guidance
www.epa.gov/quality/qa_docs.html EPA Headquarters Quality web site
www.epa.gov/region02/qa/qa_documents/air_h20_qapp04.pdf Region 2 QAPP Guidance pdf file
www.epa.gov/fedfac/pdf/ufp_qapp_v1_0305.pdf UFP QAPP Guidance pdf file
www.epa.gov/quality/qs-docs/g5m-final.pdf Guidance for Quality Assurance Project Plans for Modeling
http://cfpub.epa.gov/crem/cremlib.cfm#whitepapers November 2003 Council for Regulatory Environmental Monitoring [CREM] "Draft Guidance on the Development, Evaluation, and Application of Regulatory Environmental Models"
www.epa.gov/quality/qa_docs.html Headquarters Quality web site
www.epa.gov/region02/qa/documents.htm Region 2 QA Documents web site
http://www.epa.gov/quality1/qs-docs/r2-final.pdf EPA Requirements for Quality Management Plans (QA-R2)
pdfs/pdr-guidelines.pdf Developed Pre-Dissemination Review Guidelines (PDRGs)
http://www.epa.gov/quality1/qs-docs/g7-final.pdf Guidance on Technical Audits and Related Assessments for Environmental Data Operations (QA/G-7)
http://www.epa.gov/quality/qs-docs/g4-final.pdf EPA's Data Quality Objectives (DQO) Process
http://www.epa.gov/esd/gqc/pdf/g5g-final.pdf EPA Guidance for Geospatial-related Quality Assurance Project Plans

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