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Quality Management Plan: Full View

This page displays the Region 10 QMP with all sections expanded. The QMP also can be displayed from your point of view, whether you are a manager, a project officer, or a modeler you will be able to see which modules pertain to you, and what your roles and responsibilities might be. The current version being displayed is the "Full View" which is the fully expanded, complete version of Region 10's QMP. Other views are listed on a separate web page and are accessible using the "Views" link in the left side bar or by clicking here.

A copy of Region 10's QMP (PDF)(66pp, 360K) is available for download.


Region 10 eQMP

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Table of Contents: Complete Table



Table of Contents: Main Sections

Section 1: Quality System Foundation
Section 2: Quality System Components
Section 3: Personnel Qualifications and Training
Section 4: Procurement of Items and Services
Section 5: Document and Records
Section 6: Computer Hardware and Software
Section 7: Quality Planning
Section 8: Implementation of Work Processes
Section 9: Assessment and Response
List of Figures

Reg 10 map
About this QMP

Status: Under Revision
Effective date: January 2009
Approval Page





1 Quality System Foundation

Section 1 of the Region 10 Quality Management Plan (QMP) contains the basic Introduction to the Region 10's Quality System (QS), which states the mission, policy underlying the QS, and 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, 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.


Table of Contents: Section 1

  1.1 Mission
  1.2 Quality Assurance Policy
  1.3 Regional Organization and QA Responsibilities
  1.4 Quality System Roles, Responsibilities and Authorities
  1.5 Resources to Support the Quality System (QS)
  1.6 Independence of the Regional QA Manager
  1.7 Dispute Resolution


1 QUALITY SYSTEM FOUNDATION

1.1 MISSION

EPA Region 10's mission is to protect human health and the environment of the Pacific Northwest and Alaska for present and future generations. To achieve this mission, the Region relies on its own environmental measurements and those collected by other Governmental agencies and regulated parties to make decisions affecting public health and the environment. Our environmental objectives are to:

  • Protect diverse ecosystems and ensure healthy airsheds and watersheds
  • Prevent pollution through source reduction
  • Reduce the generation of land, air, and water pollutants
  • Clean up contaminated sites

We will use sound science and wise decision-making to accomplish these objectives by:

  • Maintaining an in-depth understanding of Region 10 and focusing our efforts on the greatest risks to human health and the environment
  • Ensuring compliance with federal environmental laws within and across boundaries, while considering national consistency and local circumstances
  • Working effectively with state and local governments, tribes, citizen groups, and industry to solve environmental problems
  • Assisting state, local, and tribal governments to develop environmental programs
  • Talking with the public about our actions and steps they can take to protect the environment
  • Promoting faster and more efficient solutions to advance sustainable environmental quality
  • Advocating regional needs and perspectives at the national level

We are accountable for achieving our mission. Our success as stewards of the public trust will be measured by meaningful and lasting environmental improvements.

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1.2 QUALITY ASSURANCE POLICY

It is EPA policy that all environmental programs performed by EPA or directly for EPA through EPA-funded extramural agreements shall be supported by individual quality systems that comply fully with the American National Standard ANSI/ASQC E4-2004, Specifications and Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology Program.

Region 10's Quality System is in compliance with the mandatory requirements set forth by the EPA Order CIO 2105 (Formerly QA Order 5360.1 A2)(PDF)(12 pp, 94K) and the specifications of the EPA Quality Manual (CIO 2105-P-01-0 formerly Order 5360.A1)(PDF)(63 pp, 3694K) which when implemented provide the needed management and technical practices to assure that environmental data used to support Agency decisions are of adequate quality and usability for their intended purpose. The QA policy also expands the applicability of QA and QC activities to the design, construction, and operation by EPA organizations of environmental technology such as pollution control and abatement systems; treatment, storage, and disposal systems; and remediation systems.


Region 10's QA Policy
  • Environmental measures are derived from the collection of data of known and documented quality, of sufficient quantity, legally defensible and is suitable for its intended use.
  • Environmental technologies utilized are supported by sound science to assure that performance will meet its intended use.

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1.3 REGIONAL ORGANIZATION AND QA RESPONSIBILITIES

EPA Region 10 is comprised of 8 Program Offices and 4 Operations Offices, one for each State, i.e., Washington, Alaska, Oregon and Idaho. Region 10's organizational structure is shown in Appendix A, Figure 1. A brief description of the Program and Operations Offices follows:

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OFFICE OF ENVIRONMENTAL ASSESSMENT (OEA)

OEA is where the Regional Science and Technology (RS&T) Director resides. OEA has the management responsibilities for the uniform implementation of the Quality System (QS) mandated by this QMP. OEA is comprised of a pool of technical specialists and experts in their fields providing specialized technical support in project planning and implementation, data evaluations, ecological and human health risk assessments, hydrogeology, GIS and other mapping tools, laboratory analytical services, field analytical support and economics/financial analyses to all media programs within and outside EPA Region 10. The Regional Quality Assurance Manager (RQAM) is located in OEA and reports to the RS&T Director. The RQAM ensures the implementation of the regions QS and provides QA oversight to EPA's special projects, internal and external environmental monitoring and measurement activities. Also located within OEA is the brokerage center for securing laboratory and analytical services called the Regional Sample Control Center- RSCC and the regional management and oversight of the Region 10 Superfund Contract Laboratory Program (CLP). Together, the RSCC, the CLP Project Officer and the RQAM ensure that the region's Field and Analytical Services Teaming Advisory Committee (FASTAC) strategy is implemented.

OEA also houses the Manchester Environmental Laboratory (MEL), Region 10's state of the art laboratory located across the Puget Sound. MEL is a NELAC certified full service laboratory operating under its own Quality Assurance Manual (QAM) and with a dedicated Quality Assurance Coordinator whose main responsibility is to ensure that the Region's specified Quality System is implemented in the laboratory.

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OFFICE OF AIR, WASTE & TOXICS (OAWT)

OAWT carries out waste and chemicals management programs under statutory authorities such as RCRA, TSCA, the Pollution Prevention Act, and EPCRA. OAWT also carries out enforcement actions dealing with lead based paint 1018 and 406 rules, AHERA (asbestos), and the Toxics Release Inventory reporting requirements. In addition, OAWT implements regulatory programs under the Clean Air Act, including development and support of collaborative projects to protect air quality. Air, waste, and toxics activities include work in permits, tribal projects, compliance assistance, TSCA enforcement, grants management, pollution prevention, technical assistance, and voluntary programs to promote sustainability. The work is accomplished through the Agency's interaction with States, tribes, local governments, non-profit organizations, and the regulated community. OAWT consults with the Office of Compliance and Enforcement on enforcement matters.

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OFFICE OF ECOSYSTEMS, TRIBAL & PUBLIC AFFAIRS (OETPA)

OETPA is the organization that ties together ecosystem health and the people who reside in those ecosystems. An ecosystem is the natural system in which energy and nutrients cycle between plants, animals and their environment. People are a part of that system, and influence the natural processes by our activities. The office is responsible for a variety of programs dealing with the interaction between people and their ecosystem – wetlands and the Clean Water Act, Endangered Species Act (ESA), ocean dredge material disposal sites, contaminated sites and environmental laws, activities related to NEPA, and tribal trust and assistance.

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OFFICE OF ENVIRONMENTAL CLEANUP (ECL)

ECL has the program management responsibilities for the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), Superfund Amendments and Re-authorization Act (SARA), and Emergency Response Programs. ECL ensures that Quality Assurance matters are properly reflected in budgets, program plans, contracts, permits, inter-agency agreements (IAGs) and work, operating, sampling and project plans. ECL serves as the technical and program authority for all Superfund and Emergency Response environmental monitoring activities within the geographical boundaries of Region 10. The environmental data arising from these programs are the product of efforts, both internal and external to the Region. Each of the ECL staff is aware and mindful of the minimum QA requirements required during remedial and clean-up activities as mandated by OSWER and the EPA Order CIO 2105 (Formerly QA Order 5360.1 A2)(PDF)(12pp, 94K).

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OFFICE OF COMPLIANCE & ENFORCEMENT (OCE)

OCE serves as the focal point for compliance and enforcement planning, guidance, and resources. This office is responsible for coordinating strategic compliance assurance efforts, measuring progress, coordinating with EPA HQ, and assisting in special enforcement or compliance assistance efforts. Most direct enforcement and compliance assurance work in the Regional Office is done by Units within this Office. Inspection and Compliance personnel work with the Quality Assurance staff (QAS) in ensuring that all of their investigations are covered by an EPA approved Quality Assurance Project Plan (QAPP) with sufficient QA/QC activities and documentation in preparation for future litigation process.

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OFFICE OF WATER & WATERSHEDS (OWW)

OWW is responsible for carrying out EPA's mandates under several laws, such as the Clean Water Act and Safe Drinking Water Act. The following are some of OWW's activities:

  • General ground water protection issues with support for State Wellhead and Source Water Protection programs
  • Preserving and restoring watersheds through providing resources including financial support to states and communities
  • Issues wastewater discharge permits in accordance with the National Pollutant Discharge Elimination System (NPDES) regulations
  • Water quality standards
  • TMDLs or surface water clean-up plans

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OFFICE OF REGIONAL COUNSEL (ORC)

The Office of Regional Counsel (ORCs) provides day-to-day support to each Region and to EPA Headquarters for all general legal matters, including defensive litigation and counseling issues. The regional attorneys draft federal rules and defend the Agency in litigation and play a unique role in ensuring that legal requirements and obligations are met. Office priorities are often driven by mandates or deadlines imposed by courts, statutes, or regulations. The regional attorneys give legal advice on: nearly 90 federal laws, numerous presidential executive orders, EPA regulations, policies, and guidelines, case decisions, international treaties, state laws and local ordinances. Specifically, ORC responsibilities entail counseling regional program staff and managers on the application of statutes, regulations, case law, and policies, as well as any other legal issues that arise. Finally, the ORC also provides legal support for all enforcement matters and supports regional and national priorities and commitments.

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OFFICE OF MANAGEMENT PROGRAMS (OMP)

OMP provides advice and support on administrative programs for all components of the Regional Office. The Office works with the Regional Administrator and senior staff to ensure that Agency goals are coordinated at the Regional level in conformance with EPA's long-term strategic plan, annual budget guidance, human capital strategy, and other applicable policies and regulations. The Director of the OMP is also the Region's designated Senior Information Officer (SIO). The SIO is accountable for ensuring the quality of the region's information and data resources. OMP also provides support to state and local agencies, tribes, educational institutions and non-profit organizations on grants assistance and partnership agreement and provides the administrative management of these funding vehicles. Other OMP functions include budget execution, financial and resources management for the Regional Office and individual programs, and management control and integrity assurance, Civil Rights, Equal Opportunity Employment and environmental justice overview and assistance, management and organization of human resources, space and facilities management, emergency and disaster response, health and safety, assistance on organizational effectiveness and management of Homeland Security and Contingency of Operations efforts.

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EPA STATE OPERATIONS OFFICES (ALASKA, IDAHO, OREGON, WASHINGTON)

The Operations Offices represent the Regional Administrator on state matters and provide leadership, coordination, and liaison with the officials of each state's environmental agency, tribes, and other federal, state, and local organizations. The Operations Offices perform Program specific functions such as facility inspections, permits, grants management and outreach, Superfund site clean-up and management, ecosystem, geographic work, and multi-media coordination.

Region 10's organizational chart is in Appendix A.

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1.4 QUALITY SYSTEM ROLES, RESPONSIBILITIES AND AUTHORITIES

The overall responsibility for the Quality Assurance (QA) Program in Region 10 rests with the Regional Administrator (RA). The responsibility to implement the management of the QA program rests with the Regional Quality Assurance Manager (RQAM), all Regional Managers and staff involved in the business lines of environmental measurements and environmental technology products and activities. Oversight responsibilities for developing and overseeing the Quality System (QS) that describes the QA program reside with the RQAM.

The Regional Administrator (RA), Senior Executive Team (ET), and managers ensure that adequate resources, including intramural and extramural money, training and travel funds, and personnel are allocated to achieve the implementation of the Region's quality policy.

This Quality Management Plan (QMP) describes the management and technical activities necessary to plan, implement, assess, and ensure the effectiveness of the quality assurance (QA) and quality control (QC) operations applied to the programs in Region 10 that are involved in the business line of environmental measures. This QMP further defines the program management's roles, responsibilities and authorities for implementing the management of Region's Quality System (QS).

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Table of Contents: Section 1.4

    1.4.1 Regional Administrator/Deputy Regional Administrator (RA/DRA)
    1.4.2 Regional Quality Assurance Manager (RQAM)
    1.4.3 Office Directors/Regional Program Managers
    1.4.4 Project Officers (POs), Contract Officer representatives (CORs) and Project Managers (PMs)
    1.4.5 Quality Assurance Staff (QAS) Team
    1.4.6 Quality Assurance Coordinators (QACs)
    1.4.7 Technical Specialists
    1.4.8 Assessors


1.4.1 REGIONAL ADMINISTRATOR/DEPUTY REGIONAL ADMINISTRATOR (RA/DRA)

The RA and DRA are committed in ensuring that Quality Assurance is an identifiable and required program with adequate resources and budget allocations to accomplish program policies and regional goals.

The QA responsibilities of the RA/DRA are as follows:

  • Ensure that all regional components and programs fully comply with the requirements of the EPA Order CIO 2105 (Formerly QA Order 5360.1 A2)(PDF)(12pp, 94K) and the specifications of the EPA Quality Manual (CIO 2105-P-01-0 formerly Order 5360.A1)(PDF)(63pp, 369K) and EPA Quality Program Policy- CIO 2106 (PDF) (11pp, 129K) and Procedure - CIO 2106-P-01.0 (PDF) (17pp, 340K), including the timely preparation of a QMP for Region 10, implementation of an effective management of the Quality System specified in the QMP and the submission of Quality Assurance Annual Report and Work Plan (QAARWP) to the Office of Environmental Information (OEI)


  • Full endorsement of USEPA Region 10's Quality System and implement Agency quality policies


  • Ensure that managers at all levels are committed to setting quality objectives and achieving quality results


  • Ensure that managers recognize and award collaborative QA efforts that promote quality performance results


  • Ensure that quality management is an identified activity with associated resources adequate to accomplish Region 10's program goals


  • Ensure that all applicable environmental programs delegated to state, tribal and local governments, or performed by organizations outside EPA comply fully with EPA regulations and requirements


  • Ensure that adequate and appropriate training relating to Quality Systems management and Quality Assurance/Quality Control issues are provided to Region 10 management and staff


  • Ensure that federal agencies and state, tribal and local governments implementing environmental measures under assistance agreements with EPA have sufficient training in Quality Systems management and Quality Assurance/Quality Control issues in order to perform the work successfully


  • Ensure that periodic Quality System Reviews (QSRs) of Region 10 organizational units, states, tribes, local governments, and other organizations implementing environmental measures for and by Region 10 are performed to assess program implementation effectiveness


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1.4.2 Regional Quality Assurance Manager (RQAM)

Region 10 has a centralized Quality System. The authority and responsibility for managing Region 10's QA program is assigned by the RA/DRA to the RQAM through the Director of OEA. The RQAM has ten performance objectives: organization structure and management support, QA planning and documentation, resource planning and management, product development and oversight, training, internal communication and outreach, external oversight, communication and outreach, program evaluation and assessment, collaboration, innovation and continuous improvement and performance deliverables.


Table of Contents: Section 1.4.2

      1.4.2.1 Organization Structure and Management Support
      1.4.2.2 Planning and Documentation
      1.4.2.3 Resource Planning and Management
      1.4.2.4 Product Development and Oversight
      1.4.2.5 Training
      1.4.2.6 Internal/External Oversight, Communications and Outreach
      1.4.2.7 Program Evaluation and Assessment
      1.4.2.8 Collaboration
      1.4.2.9 Innovation and Continuous Improvement
      1.4.2.10 Performance Deliverables


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1.4.2.1 Organization Structure and Management Support
  • Serves as principal advisor to the Regional Administrator, Deputy Regional Administrator, and Office Directors on all matters concerning the Agency's Quality System


  • Recommends policies and procedures for the management of QA/QC within EPA Region 10


  • Routinely participates in planning meetings with management on program priorities and budget decisions


  • Collaborates and facilitates integration of QA principles and concepts into cross-cutting programs


  • Ensures that QA performance elements are incorporated into PARS for management and QA staff


  • Ensures that management is involved with the RQAM and the QA staff in setting QA priorities and allocating QA resources


  • Serves as the official regional contact for all QA matters and communications from EPA Headquarters, other EPA Regions, states, tribes, local governments, and private sector

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1.4.2.2 Planning and Documentation
  • Ensures that procedures are developed for incorporating QA into environmental and non-environmental measurement activities


  • Ensures that systematic planning for QA throughout the life cycle of a project is a standard practice


  • Ensures that activities and procedures for implementing the organization QMP are documented and current


  • Develops guidance and training on the preparation of QA Project Plans, Standard Operating Procedures, laboratory protocols, QA Review forms, etc.


  • Assists contractors, grantees, States, tribes and other stakeholders in meeting EPA's QA requirements


  • Promotes an enterprise approach to quality management that allows Agency-wide access to quality information


  • Ensures that QA requirements are considered in the planning of emerging issues and new policies


  • Ensures that scientific information and products are supported by objective QA measures and documentation

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1.4.2.3 Resource Planning and Management
  • Ensures that management allocates adequate QA resources at the beginning of the budget planning cycle


  • Works with management and identifies program priorities for QA resources


  • Ensures that sufficient resources are available to allow the RQAM and QA staff to routinely evaluate organization's quality system for performance results and to provide training external partners, as needed


  • Ensures that there is systematic approach in QA funding tracking and in documenting QA records

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1.4.2.4 Product Development and Oversight
  • Reviews cross-cutting reports and final products for the required QA documentation


  • Ensures that the regulatory programs comply with EPA QA requirements and that final work products are reviewed for QA documentation prior to publication/dissemination


  • Ensures that procedures for peer review and product dissemination for Agency-wide work products are consistently applied and accessible to QA community


  • Ensures that the quality of data and QA requirements are documented for products reviewed by external parties


  • Ensures that the QA staff participates in scoping and technical meetings during product development


  • Ensures that Data Quality Objectives (DQOs) are routinely determined at the start of the project and Data Quality Assessment (DQA) is conducted at the end of the project


  • Ensures that performance of DQA is routinely accomplished by QA staff in reviewing final work products


  • Ensures that verification and validation of products and services are aligned with existing Plan, Do, Check, Act (P-D-C-A) paradigm

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1.4.2.5 Training
  • Assesses regional QA training needs and develops training for management and staff, as needed. Develops “tailored training “ for QA staff, Project officers (POs), Project Manager (PMs), CORs, COs and others to meet the quality needs of the organization for other lines of business


  • Provides training on QA requirements for extramural projects including grants, inter-agency grant (IAGs) agreements, partnership agreements, etc. Assists States, tribes and other non-EPA stakeholders to meet their training needs


  • Participates and collaborates with other regional, federal and state programs on activities such as sampling events, inspections/audits of laboratories and program internal assessment, to gain knowledge on QA concerns from clients perspectives and form partnerships in developing and delivering collaborative types of training


  • Maintain appropriate QA staff expertise to assist customers with QA issues

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1.4.2.6 Internal/External Oversight, Communications and Outreach
  • Reviews, comments, and approves/disapproves of the programs' QAPP, SOPs, SOWs, and other QA documents used for internal and external Regional environmental measures, except in situations where the state, tribal and local agencies have been granted QA-related document approval authority through the RQAM's approval of the organization's QMP


  • Assists Region 10 staff in the development of internal program Quality Assurance Project Plans (QAPP). Develop a relationship of trust with customers and promote discussion/acceptance of new QA requirements based on program needs. Communicate QA requirements in user friendly terms


  • Assists the regional programs in integrating EPA QA Program requirements into the scopes of work for states', tribes' and local organizations' grants, contracts, and partnership agreements


  • Creates flexibility and use graded approach in assisting the states, tribes, grantees and other stakeholders in the development and approval of their QMPs and QAPPs. Establish a network of QA expertise for assisting States, tribes and other EPA partners to meet QA requirements for environmental data collection and documentation


  • Promotes and facilitates integration of QA into program activities and establish procedures to ensure that appropriate QA planning and documentation occurs in all intramural and extramural agreements for applicable products and services


  • Serves as a Technical Evaluation Panel (TEP) member for Regional procurement where environmental measures are involved

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1.4.2.7 Program Evaluation and Assessment
  • Reviews the effectiveness of the implementation of the program's QAPP and determines the adequacy of the data generated for its intended use. Evaluates implementation of corrective actions for effectiveness


  • Coordinates and conducts routine and periodic Quality and Technical System Reviews (QSRs/TSRs) of the Region's internal and external environmental monitoring programs


  • Collaborates with other federal agencies, industry, and academia on best practices for QA. Reports successful coalitions and collaborations on QA to top management and QA community


  • Consistently conducts external audits and assessments on extramural projects

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1.4.2.8 Collaboration
  • Participates in QA conferences, training and workshops


  • Participates in OEI's Quality System Review (QSR) of Region 10


  • Presents and discusses common issues at monthly QA community conference calls


  • Establishes “Region-HQ connection” by having clearly defined program-specific QA requirements


  • Leads special workgroup efforts for advancing and improving EPA's Quality System

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1.4.2.9 Innovation and Continuous Improvement
  • Develops guidance for secondary data use


  • Conducts annual QA Team/PO brainstorming sessions on QA performance


  • Establish protocols for implementing corrective actions


  • Advocates for objective standards for data generation, use and reporting


  • Adopts an enterprise and risk management approach for quality decisions

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1.4.2.10 Performance Deliverables
  • Develops and revises the Regional QMP


  • Prepares and submits QAARWP to regional Management and OEI


  • Reviews and approves applications for Alternate Test Procedures (ATP)

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1.4.3 Office Directors/Regional Program Managers

Office Directors and Program Managers are responsible for ensuring that the internal and external data collection activities within their area of responsibility are conducted in accordance with EPA's QA policies and associated requirements. The key responsibilities of Office Directors and Regional Program Managers are:

  • Ensure that effective implementation of the management of Region's Quality Systems and other QA matters are reflected in monitoring budgets, program plans, and operating plans


  • Ensure that a systematic planning process is implemented (e.g., DQO) for monitoring activities


  • Review and evaluate internal and/or external monitoring of implementation and progress of any management of Quality Systems within their areas of responsibilities


  • Review and evaluate the quality and quantity of data generated by monitoring projects


  • Take corrective action as required by QA audits, assessments, or reviews.


  • Oversight of any Regional Program implementation of the Quality Systems management and QA activities


  • Report data quality problems to RQAM.


  • Ensure that all staff is aware of the requirements of this QMP


  • Ensures that staff comply with this policy and the EPA Order CIO 2105 (Formerly QA Order 5360.1 A2)(PDF)(12pp, 94K)


  • Request appropriate training for staff to comply with the Agency and Region 10's QA policies

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1.4.4 Project Officers (POs), Contract Officer Representatives (CORs) and Project Managers (PMs)

The following are the QA oversight and management responsibilities of the Contract Officer Representatives (i.e., Project Officer, Work Assignment Manager, Delivery Order Project Officer, or Task Order Project Officer). These are applicable to sites that are fund or non-fund leads, IAGs, contracts, grants and other environmental data collection activities conducted by and for EPA use:

  • For all solicitations, the COR must coordinate with the organization's QA Manager to determine whether any quality-related documentation or activities are necessary. The COR must provide the QA Manager with a copy of the Statement of Work for the proposed contract and the completed QA Review Form for the QA Manager's signature.


  • If quality-related documentation or activities are required for a solicitation or a Statement of Work under a multiple award contract, and the potential value of the procurement exceeds $500,000, or the estimate of the percentage of costs or level-of-effort allocated to activities requiring quality requirements exceeds 15%, or procedures defined in the Quality Management Plan of the COR's organization apply, then the COR must coordinate with the QA Manager to:

    1. develop the Technical Evaluation Criteria, and any associated technical instructions, for the Request for Proposal, and


    2. ensure that the QA Manager serves as a member of the Technical Evaluation Panel (when convened) for the purpose of evaluating the QA aspects of the technical proposals.

  • After award of the contract, the CORs must ensure that the quality-related requirements as defined for the contract are included in each Statement of Work under the contract and that a signed QA Review Form is attached to each Statement of Work. The COR should monitor the work of the contractor (including items relating to quality) and inform the Contracting Officer of any problems.


  • Both before and after award of the contract, the COR must also perform any responsibilities defined in his or her organization's Quality Management Plan, such as reviewing and approving QA Project Plans, and reconciliation of data with project and data quality objectives.


  • CORs must ensure that an EPA approved QAPP following the Uniform Federal Policy for Quality Assurance Project Plans (UFP-QAPP) guidance (PDF)(126pp, 989K) or the current version of the EPA Requirements for Quality Assurance Project Plans, EPA QA/R5 March 2001 (PDF)(40pp, 121K), are in place before starting the collection or use of environmental information. For projects performed by Potentially Responsible Parties (PRP), PMs shall also ensure that enforcement instruments contain the QAPP requirement.

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1.4.5 Quality Assurance Staff (QAS) Team

The QAS team is comprised of experienced chemists and technical experts authorized by the RQAM to review, provide comments and rationale for the approval/disapproval of the QA planning documents. They have the delegated authority from the RQAM to approve/disapprove site or project specific QAPPs, Field Sampling Plan(s) (FSPs) and Work Plan(s) (WP). They assist the RQAM in the development, preparation and review of program and project or site specific QAPPs. The QAS team works with the program and project managers to implement the management of Region 10's Quality System. In addition, the QS team provides data validation and assessment of the internal and extramural data generated for the programs. The key responsibilities of the QAS team are:

  • Review Program QA documents, such as QMPs, WPs, QAPPs, FSPs, SOPs, and SOWs, used for the regional internal and external data collection activities and provide rationale and recommendations for approval or disapproval to the RQAM


  • Assist the RQAM in coordinating QA oversight activities within the Region including Quality Systems Reviews (QSR) and Technical Systems Reviews/Audits (TSR/A) of States, laboratories and field activities


  • Prepare TSR/A, QSR and/or other QA assessment reports


  • Develop and update generic program QAPPs


  • Maintain and update inventories of field analytical support group


  • Maintain and update SOPs of the Region 10 Field Operations Group (FOG)


  • Provide data validation and assessment expertise to the programs


  • Participate during the planning, implementation and evaluation phases of special projects designed to meet national and regional initiatives


  • Advise the RQAM on changes needed to Region 10's QMP


  • Assist the RQAM in resolving QA issues with national and regional implications


  • Coordinate program's input for Region 10's QA annual report and work plan (QAARWP), prepare and submit this document to the RQAM for review and subsequent submission to OEI


  • Work with Region 10 staff to develop and maintain an effective QA program


  • Assist the RQAM in the preparation, planning, coordination and training of the Regional staff, states, local, tribes, and other organizations involved in environmental data collection


  • Through the Regional Sample Control Coordinator (RSCC), coordinate sampling and analysis activities with the Regional Laboratory and the Contract Laboratory Program (CLP) laboratories and provide regional sample tracking numbers, custody seals and custody documentation to the field samplers


  • Serve as the Document Control Officer (DCO) whose responsibility is to ensure that completed/signed QA documents given to the DCO are filed in a centralized QA file system


  • Enter into the QA tracking system all work requests accepted by the RQAM, QAS, and technical specialists


  • Serve as the Regional Project Officer (PO) for the Superfund's CLP. Provide technical direction, regional management, oversight and authorize payment of invoices from the CLP laboratories


  • Conduct evidentiary audits of CLP data packages. Obtain program authorization and coordinate with the Superfund Record Center (SRC) the data storage transfer of old (3-6 months) CLP data packages to the Federal Record Center (FRC)


  • Review data submitted through the Contract Laboratory Program (CLP) and by potentially responsible parties when requested


  • Participate in national and regional QA workgroups


  • Carry-out any additional program specific responsibilities as may be assigned by the RQAM

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1.4.6 Quality Assurance Coordinators (QACs)

There are two QACs in Region 10. The QACs manage focused Quality Systems in their offices, i.e. the US EPA Region 10 Manchester Environmental Laboratory and the Emergency Response Unit in ECL. The QACs have the RQAM delegated authority to review and approve QA documents designed specifically for the implementation of their program specific Quality System. The Quality Assurance Plan/Manual which the two offices have is the framework under which the focused Quality System is managed. The key responsibilities of the QACs are:

  • Act as technical advisor to their management and staff in the formulation of QA procedures based on general policy provided by the RQAM


  • Ensure the implementation of QA policy, reviews QA/QC data, and verifies that corrective action was taken when necessary


  • Prepare periodic reports (at least one annually) to RQAM and management documenting the quality assurance data, assessments and performance of their organizations


  • Coordinate the planning and implementation of the annual internal QA/QC management system audits of any subgroups within their Quality System


  • Provide a copy of the internal QA/QC management system audit reports to the RQAM


  • Ensures that corrective actions resulting from these audits are addressed in a timely manner


  • Identify the need for and coordinates revisions to their organization's QA Plan/Manual, SOPs, and other QA documents


  • Reviews and approves/disapproves QA document submitted by the contractors for their program-specific data collection activities


  • Ensure that the environmental data generated by their program(s) are in compliance with the Quality System requirements specified in the Region 10 and their organization QMPs


  • The Laboratory QAC is responsible for ensuring the Agency's Laboratory Competency Policy is implemented by obtaining and maintaining accreditation through a nationally recognized accreditation body


  • Assist in the planning and preparation of QA/QC training for regional program staff


  • Carry-out any additional program specific responsibilities as may be assigned by the RQAM

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1.4.7 Technical Specialists

To ensure that a satisfactory level of QM and QA capabilities are maintained in Region 10, the RQAM has the authority to request and access technical assistance from the technical specialists within EPA Region 10. These personnel have expertise in specific areas such as: air, water, drinking water laboratory certification, compliance monitoring, field operations, chemistry, risk assessment, hydrogeology, microbiology, environmental economics, biology, and data processing. Upon RQAM's request through the appropriate management, the technical specialists shall operate with and/or on behalf of the RQAM. The following duties may be assigned to the Technical Specialists:

  • Conduct system and performance evaluations of SLAMS/NAMS and Prevention of Significant Deterioration (PSD) special studies monitoring networks


  • Conduct network reviews of regional air and water monitoring and modeling programs


  • Provide expert economics and financial analysis support to regional and national programs, international agencies and other federal, state, tribes, local environmental organizations


  • Inform RQAM of the need for new or improved methods for sample collection, detection limits, data analysis and data assessment


  • Participate in technical assistance and training of state/local, and private laboratory personnel in EPA methods, instrumental, and QA requirements


  • Review subordinates' and associates' data for QA before transmittal to the requester and finalization in the data system


  • Interact with other Agency programs on technical problems related to QS management, Quality Assurance, methods, instrumentation, and new programs


  • Review QA documents for technical accuracy and appropriateness

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1.4.8 Assessors

Assessors are responsible for the actual planning, coordination, evaluation, reporting and documentation of field and laboratory assessments. They are responsible for follow up to the assessments and evaluation of the response actions. The authority to assess is derived from EPA Order 5360.1 A2. Assessment authority is confirmed in the planning stage for each assessment. For quality system assessments performed by the QA Staff, the RQAM obtains concurrence of the senior management of the organization being assessed. The purpose, scope and time frame for the assessment are documented in an assessment plan. For technical systems audits, the Lead Assessor and the Project Manager concur on the assessment's purpose, scope and time frame. These may be documented in a letter or in the final report for an assessment requested on short notice. Confirming the authority to assess in the planning stage of an assessment allows access to programs, managers, documents and records, and provides the organizational freedom to identify both problems and noteworthy practices, propose recommendations, and verify implementation and effectiveness of corrective actions.

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1.5 RESOURCES TO SUPPORT THE QUALITY SYSTEM (QS)

The Region provides in-house expertise in the implementation of quality assurance and other technical support in several scientific disciplines to all employees and programs in the Region. These support services include data needs assessment, data quality assessment, data analysis, risk evaluation and modeling provided by chemists, toxicologists, hydrologists, engineers, and others. Personnel providing these services are located in a number of Regional Program offices but most of them reside at OEA.

Through workload models, EPA Headquarters (HQ) recommends funding levels for Quality Management activities in each of the monitoring programs. The budgeting process reflects a policy of sharing resources between organizational units within the office. The OEA Director and the Program Directors involved in data collection activities jointly determine the level of QA resources needed to be allocated to OEA, to ensure program compliance and the implementation of the management of Region 10's Quality System. Region 10 Executive Team allocates the enabling Quality System (QS) management resources to the OEA Director. The OEA Director, in turn, distributes these QS management resources within OEA. A portion of these resources allocated to OEA is dedicated to the continuing support of the RQAM and the implementation of the QS within the boundaries of Region 10 with the balance distributed to the units responsible for providing technical support to the media Programs. The amount and distribution of QS management resources in the Region is not static, but a dynamic function of the changing emphases and priorities of the Agency monitoring programs. Therefore, staffing and travel resources allocated to the RQAM for each fiscal year varies and are identified in the QAARWP.

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1.6 INDEPENDENCE OF THE REGIONAL QA MANAGER

EPA Order CIO 2105 (Formerly QA Order 5360.1 A2)(PDF)(12pp, 94K) requires that the RQAM function independently of the programs involved in environmental data collection activities and that this individual report to a senior manager with executive leadership authority for the organization. EPA Order CIO 2105 (Formerly QA Order 5360.1 A2)(PDF)(12pp, 94K) further requires that the office directly responsible for implementing the Region's QS be provided the authority and necessary resources to carry out the requirements of the QA order.

Region 10's RQAM is a non-supervisory program management position located in OEA, reports directly to the Office Director (OD) and functions independently of direct environmental data generation, model development or technology development responsibilities. The RQAM has authority to go directly to the RA/DRA and find resolution to critical QA problems and disputes. The RQAM has sufficient technical, management expertise, and authority to provide independent oversight of and assure the implementation of Region 10's Quality Systems in the environmental programs. From various Regional Program Offices, the RQAM has the authority to access and utilize QA staff and technical specialists needed to support the management of the Regional Quality Systems. This provides the RQAM with sufficient authority and technical resources to assure the independent implementation and oversight of the regional quality system throughout EPA Region 10.

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1.7 DISPUTE RESOLUTION

For those situations in which QA issues are in dispute, resolution shall be sought at the lowest management level possible. Such disputes may occur in situations involving technical issues (e.g., audits and data quality assessments) and management issues (e.g., QMP reviews, QAPP reviews, quality system reviews, and data usability assessments).

All parties involved shall make every effort to resolve disputes through discussion and negotiation. If the agreement could not be reached at this level, the issue will be resolved by the RQAM and/or the Office Directors. QA issues or disputes with the program offices are presented by RQAM to the program's senior management for resolution. The RQAM has direct access to the RA/DRA to resolve any potential conflict of interest posed by the RQAM's organizational location in OEA. The RA/DRA has final dispute resolution authority on all Region 10 QA issues.

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Reg 10 map

2 Quality System Components

Section 2 of the Region 10 Quality Management Plan describes the different types of data collection activities that are performed by and for Region 10 and the Quality System components and planning tools that are required to meet the mandatory EPA Quality System requirements. It also highlights the general QA responsibilities of the regional staff responsible for the projects and sites conducting the environmental measurement activities.


Table of Contents: Section 2

  2.1 Program Quality System Tools
  2.2 Information Quality Guidelines


2 QUALITY SYSTEM COMPONENTS

The uniform and consistent application of Region 10's Quality System Processes and Quality Policy are required for the following products and services:

  • Data and information and their resulting products and services produced for public use or access by partners, stakeholders or organizations outside the agency. Organizations must ensure the application and documentation of uniform and consistent quality practices on products and services intended for external dissemination which are subject to high level of scrutiny under the Information Quality Act.


  • Data and information and their resulting products and services produced for cross-program business activities internal to the Agency. Products and services developed by one EPA organization for use by other Agency organizations are expected to utilize consistent quality practices and processes.


  • Products and services produced by individuals or organizations outside of EPA that support aspects of EPA's mission. Products and services produced by individuals or organizations outside EPA are also subject to applicable EPA quality requirements under federal extramural agreements.


  • Administrative or financial management systems, information technology applications or other technology-enabled systems developed for use by EPA offices and/or partners or stakeholders (including regulated parties) external to the Agency.


  • Technology, systems or devices acquired or developed for use in environmental monitoring, characterization, remediation, control, research, energy development or use or other areas pertinent to EPA's mission.

To effectively manage and implement the Region's quality system, environmental monitoring activities, technologies and product development, systematic planning, routine review, peer review and approval of project specific QA planning documents and assessment of the quality of data generated are required. The following sections discuss the quality system tools used in planning, implementation and oversight of the Region's quality system:

2.1 PROGRAM QUALITY SYSTEM TOOLS


Table of Contents: Section 2.1

    2.1.1 Quality Assurance Management Plan (QMP)
    2.1.2 QA Annual Report and Work Plan (QAARWP)
    2.1.3 Quality System Assessments
    2.1.4 Project Quality System Tools


2.1.1 QUALITY ASSURANCE MANAGEMENT PLAN (QMP)

All organizations conducting data collection activities for EPA's eventual use are required to have an EPA approved QMP. The QMP must address the QA elements specified in the “EPA Requirements for Quality Management Plans”, EPA QA/R-2, March 2001 (PDF)(30pp, 87K) or the most recent version. After the review and approval of the organization's QMPs, the authority to review the organization's site or project specific QAPPs and other QA planning document is delegated by the RQAM to the QA program of the organization. The approved QMPs must include a description of the preparation, review and approval process for specific QAPPs covered by the organization's grant. The approved QMPs shall be in effect for a period of no more than five years. Before the expiration date of the QMP, the organization shall revise their QMPs in accordance with EPA QA/R-2, March 2001 or the most recent version. Only two programs within the regional office have their own EPA approved program QMP, i.e., the EPA Manchester Environmental Laboratory and the Emergency Response Unit at the Office of Environmental Clean-up. Revisions and amendments to the approved QMP must be approved by the RQAM prior to implementation. The RQAM shall maintain a list and copies of the approved QMPs and their expiration dates.

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2.1.2 QA ANNUAL REPORT AND WORK PLAN (QAARWP)

The QAARWP is a summary of specific activities within the Region's QS. The Region's implemented QA activities of the previous fiscal year and the planned QA activities for the upcoming fiscal year are summarized in the QAARWP. The QAARWP is prepared according to Chapter 4 of the most current version of the EPA Quality Manual CIO 2105-P-01-0 (formerly Order 5360.A1)(PDF)(62pp, 369K) by the RQAM, and/or the QAS with inputs from the QACs, CORs and the PMs and used to identify minor changes or updates to Region 10's QMP. The QAARWP is initially submitted electronically to the OEI Office Director (OEI-OD) at the end of each year (or other date as specified by the OEI-OD). The electronic submission is then followed by a hard copy of the QAARWP signature page signed by the RQAM, OD-OEA, RA/DRA.

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2.1.3 QUALITY SYSTEM ASSESSMENTS

Program assessments are conducted by performing a Quality System Review/Audit (QSR/QSA). QSR is a qualitative evaluation of a data collection operation and/or organization(s) to determine whether the current quality management structure, policies, practices, and procedures are adequate for ensuring that the type and quality of data needed are obtained. QSR is a tool used to determine the effectiveness of, and adherence to, the quality system and the adequacy of resources and personnel provided to achieve and ensure quality in all activities. The focus of these assessments is on the quality system process not on evaluating the quality of specific products -- not judging the quality of environmental data or the performance of personnel or programs.

Depending on the availability of resources, OEI Quality Staff performs an independent QSR of Region 10's Quality System once every three years. The Region 10 QSR Team comprised of the RQAM, QAS and/or technical specialists conduct QSRs of the USEPA Region 10 Manchester Environmental Laboratory every two years [as required by the Regional Science and Technology (RS&T) Directors]. QSRs of contractors, State, Tribes and other agencies are performed every three years following the “Quality System Assessment Guidance (PDF)(83pp, 555K)”, EPA QA/G3, March 2003.

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2.1.4 PROJECT QUALITY SYSTEM TOOLS


Table of Contents: Section 2.1.4

      2.1.4.1 Quality Assurance Project Plan (QAPP)
      2.1.4.2 Generic QA Project Plans
      2.1.4.3 Standard Operating Procedures (SOPs)
      2.1.4.4 Data Quality Assessment
      2.1.4.5 Data Verification and Validation
      2.1.4.6 Technical System Review/Audit (TSR/TSA)


2.1.4.1 Quality Assurance Project Plan (QAPP)

All environmental data collection activities conducted within the region must be covered by an EPA approved QAPP prepared in accordance with the Agency required Uniform Federal Policy for Quality Assurance Project Plans (UFP-QAPP) guidance www.epa.gov/fedfac/documents/qualityassurance.htm or the most current version of the EPA Requirements for Quality Assurance Project Plans, EPA QA/R5 March 2001 (PDF)(40pp, 121K). A QAPP is a technical planning document that defines the project's Data Quality Objectives (DQOs), project management and functional organization, sample collection and field methodologies, chemicals of potential concern (COPCs) and project reporting limits, laboratory and analytical methods, and the QA and QC associated with all field and laboratory activities. The QAPP must be submitted to the RQAM at least 30 days before the start of a project to allow sufficient time for review, revision and laboratory space coordination, if needed. All QAPPs must be reviewed and approved by the RQAM or designee prior to sample collection.

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2.1.4.2 Generic QA Project Plans

(Note: This section is under development) Generic QA Project Plans were prepared by the RQAM, maintained and updated by the QAS to assist and provide field personnel and inspectors from the Office of Waste and Chemical Management, Office of Environmental Assessment and Region 10 State Offices with basic guidelines for the collection of samples, proper sample documentation and the use of correct sampling and analytical methodologies in the collection of “samples of opportunity” to verify and determine facility compliance. Enforcement and inspection-related samples collected are usually to the EPA Manchester Environmental Laboratory (MEL) located in Port Orchard, WA. These Generic QAPPs were prepared in compliance with the EPA Order CIO 2105 (Formerly QA Order 5360.1 A2)(PDF)(12pp, 94K), and in accordance with the Agency required QA EPA/R-5 “EPA Requirements for Quality Assurance Project Plans, March 2001 (PDF)(40pp, 121K)," and the “QA EPA/G5 “EPA Guidance for Quality Assurance Project Plans, December 2002 (PDF)(111pp, 400K). The following generic QAPPs are available for download:

  • Generic QAPP for RCRA Compliance Inspections
  • Generic QAPP for Polychlorinated Biphenyl (PCB) Inspections
  • Generic QAPP for the Concentrated Animal Feeding Operations (CAFO) Program
  • Generic QAPP for Aquaculture NPDES Compliance Inspections
  • Generic QAPP for Asbestos Inspection (AHERA, NESHAP & CERCLA)
  • Generic QAPP for Underground Injection Control Compliance Inspections
  • Generic QAPP for Stormwater Compliance Inspection
  • Generic Facility QAPP for Motor Vehicle Waste Disposal Sites
  • Generic QAPP for Seafood Processing Facility Inspections

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2.1.4.3 Standard Operating Procedures (SOPs)

Data collection and generation procedures are standardized and published as written protocols for inclusion by reference in QA Program Plans, QAPP, Sampling and Analysis Plans (SAPs), FSPs, contracts and similar documents, and for use as guidance and technical assistance documents. SOPs are prepared using the “Guidance for the Preparation of Standard Operating Procedures, EPA QA/G-6 (PDF)(60pp, 336K)”, April 2007. SOPs require RQAM review and approval and are generally integrated as addendums to the QAPP submitted for RQAM review and approval. Program Specific SOPs are prepared primarily by five groups: EPA Region 10, when performing the lead in an EDCA, IAG recipients (such as the U.S. Army Corps of Engineers, U.S. Geological Survey, or U.S. Department of Energy), grantees (such as States, Tribes, and Universities), PRPs, contractors and other government entities (i.e., Federal facilities). The responsibility for preparing, updating and approving SOPs rests with these parties, although the Region 10 RQAM may comment or require SOP revisions/modifications depending on the nature of the project. These groups are encouraged by the Region to develop program-specific SOPS for recurring activities. The RQAM and/or designated technical specialist may assist in the preparation of site-specific and program-specific sampling and analytical SOPs. To avoid duplication of effort, an SOP prepared by one program may be utilized by another program, when applicable. This will only be done with the permission of the originating party unless that party is under contract to EPA.

SOP revisions are prompted when the following situations occur and should be reviewed yearly:

  • Significant update/revision of procedures to improve method efficiency or changes due to instrument up-grades or new technologies


  • Modification of methods or previously approved SOPS to address project or site-specific needs (e.g., need a lower detection limit for an analytical method)


  • Promulgation of new regulations or their revisions requiring the addition of new or revisions of existing SOPS due to more stringent and higher environmental standards


  • Change of contract awardees

SOPs affected by these criteria will need to be updated during the year of the change. The one year rule for revision and update may be waived on a case-by-case basis due to resource constraints or where the change is so minor that the quality of the data generated are unaffected. In these cases the minimum frequency for update will be every three years. When significant changes occur in the contract or organization, SOPs are revised and submitted to RQAM or the QACs for review and approval as addendums to the QA planning documents. These significant changes are included in the planning documents submitted by the contractor or EPA PM. In addition, periodic field and laboratory visits are performed by the QA team to ensure that activities are conducted in accordance with the SOPs. Revisions to Region 10 program SOPs must be submitted to the RQAM for review and approval.

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2.1.4.4 Data Quality Assessment

Data Quality Assessment is used to assess the type, quantity, and quality of data generated in order to verify that the planning and project objectives, Quality Assurance Project Plan components, and sample collection and analytical procedures were satisfied and that the data are suitable for its intended purpose. It is the responsibility of the PO to evaluate, statistically and scientifically, the project data, both during the project and after completion. 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.

The following data assessments tools are also available for Region 10 to use for the CLP generated environmental data sets: Contract Compliance Screening for CLP organic analyses, for laboratory deliverables through the Electronic Data Exchange and Evaluation System (EXES). EXES include a self-inspection tool for CLP laboratories that provide an Electronic Data Deliverable (EDD) in the Staged Electronic Data Deliverable (SEDD) format. Using the EXES web-based system, laboratories upload their EDD and receive an e-mailed report outlining any compliance issues found in the EDD. This allows CLP laboratories to inspect the contractual completeness and compliance of their EDD prior to delivery to EPA, resulting in a more compliant deliverable for CLP customers. In addition, electronic data reviews of the SEDDs are conducted by ASB during EXES process and provides validated results based on Stage 2A EDD deliverables to the regions. SEDD electronic data validation checks 100% of the calculations. To access EXES, visit the SMO Customer Service Web site.

For CLP inorganic analyses, ASB uses the Web-based Contract Compliance Screening (WebCCS) system to provide contract compliance screening to laboratories. WebCCS is able to determine the contractual compliance and completeness of data submitted by the laboratories, prior to delivery to EPA. Following these evaluations, a defect report is generated and emailed to the laboratory. For more information visit the WebCCS software Web site.

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2.1.4.5 Data Verification and Validation

Data verification and validation is used to evaluate whether data has been generated according to specifications, satisfy acceptance criteria, and are appropriate and consistent with their intended use. Data verification is a systematic process for evaluating performance and compliance of a set of data when compared to a set of standards to ascertain its completeness, correctness, and consistency using the methods and criteria defined in the project documentation. Data validation follows the data verification process and uses information from the project documentation to ascertain the usability of the data in light of its measurement quality objectives and to ensure that results obtained are scientifically defensible. The analytical laboratory usually performs data verification prior to the release of analytical results to clients. Data validation determines the bias, usability limitations of the generated data based on meeting the project goals and QAPP specifications. Region 10 uses a graded approach when conducting data verification and validation. The validation levels depend largely on project needs and public visibility and are defined in the QA document “Draft Guidance for Labeling Externally Validated Laboratory Analytical Data for Superfund Use”, OSWER No. 9200.1-85, EPA 540-R-08-005, November, 2008. Region 10 has no contract support for data validation. The RQAM and QAS are responsible for providing data validation support to the programs, and partners, when needed. Region 10 QA program also works with OSWER's Analytical Services Branch (ASB) and use ASB's data assessment tools to evaluate contract compliance and electronically validate the analytical data generated by the Superfund Contract Laboratory Program. For data verification and data validation, Region 10 follows the QA and technical specifications of the QAPP and analytical methods, the procedures set forth in the Guidance for Data Verification and Data Validation (G8), applicable National Functional Guidelines for Organic and inorganic Analyses and Region 10 Data Validation Guidelines.

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2.1.4.6 Technical System Review/Audit (TSR/TSA)

A technical audit or assessment is a systematic and objective examination of an intramural or extramural project to determine whether (a) environmental data collection activities and related results comply with the project's QA Project Plan, (b) procedures defined by the QA Project Plan are implemented effectively, and (c) sufficient and adequate data and QC activities are obtained to achieve the QA Project Plan's data quality goals. Proper use of technical reviews and assessments provides important information to management to help ensure that collected environmental data are defensible. It can uncover deficiencies in physical facilities, equipment, project planning, training, operating procedures, technical operations, custody procedures, documentation of QA and QC activities as well as quality system aspects applying to more than one project. Technical system reviews can be performed before, during, and after environmental data collection.

TSRs of Superfund contractors like Remedial Action Contract (RACs), Environmental Services Assistance Team (ESAT), Superfund Technical Assessment & Response Team (START) and PRP contractors are coordinated, scheduled and conducted by the RQAM, QAS and/or designated technical specialists and the POs/RPMs on as per request basis, such as before the project starts or when problems are identified through data validation. Laboratory TSRs are performed on Superfund's CLP laboratories located within the Region at least once per year. State, Tribal and Territory drinking water laboratories certification and TSRs are conducted every three years by the Regions Certified SDWA Auditors. The RQAM and/or designated technical specialists also perform TSRs of commercial laboratories contracted by the PRPs, Federal facilities, RCRA owner/operators, National Pollution Discharge Elimination System (NPDES) dischargers and the Underground Injection Control Program upon request or as needed by the POs/RPMs. TSRs of internal programs and external organizations will be conducted by the TSR. Technical System Audits are performed following the Technical System Audit Guidance (PDF)(101pp, 255K), January 2000.

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2.2 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 disseminate. 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). EPA Region 10 is using a multi-faceted approach to implement EPA's Information Quality Guidelines and conduct Pre-Dissemination Reviews (PDRs). The key components of the Regional PDR implementation plan include:

  • Identifying information products


  • Implementing office review procedures, including the roles of authors, managers, and reviewers


  • Utilizing existing Region-wide mechanisms that ensure quality, including:


    • Regional QA Review conducted by the Office of Environmental Assessment
    • Regional Product Review conducted by the Office of Ecosystems, Tribal and Public Affairs
    • Regional Peer review coordinated by the Office of Environmental Assessment
    • Regional Executive Team and supervisor briefings

  • Distributing non-EPA information and the use of disclaimers


  • Providing Regional contacts for IQG and PDR

Table of Contents: Section 2.2

    2.2.1 R10 Office Review Procedures
    2.2.2 Types of IQG Review Processes, Roles, and Responsibilities
    2.2.3 Other Regional Review Processes that Are Considered Equivalent to PDR
    2.2.4 Documentation
    2.2.5 Distributing Non-EPA Information and Use of Disclaimers


2.2.1 R10 OFFICE REVIEW PROCEDURES

Region 10 Offices utilize various review processes to ensure that the quality of information products is adequate for the intended use and that the content of the information product has objectivity, utility, and integrity as defined in EPA's Information Quality Guidelines. Staff and management have roles and responsibilities, described below, to ensure that pre-dissemination review procedures are successfully implemented and that the quality of information is known and documented prior to its use. Unless impracticable, information products should be reviewed by at least one person in addition to the author. Here's a link to the PDR checklist.

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2.2.2 TYPES OF IQG REVIEW PROCESSES, ROLES, AND RESPONSIBILITIES

Whenever possible, existing review procedures will be used for IQG pre-dissemination reviews. The Region is incorporating and integrating the IQG quality components of objectivity, utility and integrity into existing review procedures. The following describes the menu of various review processes, roles, and responsibilities for staff and management to implement IQG pre-dissemination reviews. One or more review types may be appropriate depending upon the nature and importance of the information or product. Authors and supervisors who are developing an information product subject to Pre-dissemination Review should use best judgment in determining which of the review procedures listed below are most appropriate.

2.2.2.1 Author's Review

The author is considered a person or persons preparing an information product for dissemination. The primary author has the main responsibility to ensure that the informational content of a product is technically sound, meets the project's objectives, and fulfills the objectivity, utility, and integrity criteria of EPA's Information Quality Guidelines.

In some cases, the primary author may have had others (i.e. GIS or risk assessment staff) to prepare all or part of the material required to generate an information product. These technical support staff also have a role to ensure that the tools used to do the analysis are appropriate for meeting the primary author's stated purpose, that the data sources used are as defined in the project plan, and that the output produced has provided a reliable rendering of the analysis. The supervisor of technical support staff is responsible for the quality of their work.

2.2.2.2 Management Review

The direct supervisor is the person or persons who supervise the author or authors of an information or product for dissemination. The direct supervisor of the author is responsible for the quality of all documents and products (including documents and products not subject to EPA's IQG) generated within his/her Unit.

Direct supervisors should review all disseminated information products that:

  • have significant policy implications
  • set an important precedent
  • involve important emerging issues
  • are significantly controversial
  • have major cross-organizational impacts
  • represent a significant investment of Agency resources

They should also review other documents and products that sound professional judgment dictates.

Direct supervisors can delegate to appropriate staff the review of documents, especially those documents that do not meet the circumstances described above.

The direct supervisor is also responsible for conformance of information products to applicable EPA policy. The direct supervisor's review of disseminated information products includes the responsibility to ensure that the quality of such products is adequate for their intended use; that the content of the information product has objectivity, utility, and integrity as defined in EPA's Information Quality Guidelines; and that the product is aligned with applicable program policies.

2.2.3 OTHER REGIONAL REVIEW PROCESSES THAT ARE CONSIDERED EQUIVALENT TO PDR

2.2.3.1 Informal External Reviews

EPA Region 10 periodically solicits reviews of documents and information products from qualified individuals who are external to the region. External review is principally to ensure that the product is technically sound. Examples of external reviewers include experts from:

  • other EPA offices, regions, laboratories, or Headquarters
  • states or tribes
  • interstate organizations
  • Colleges or universities

A manager or designated senior staff person has the responsibility to coordinate and oversee all external reviews. Although a formal review charge is not required, Regional personnel have a responsibility to ensure that external reviewers are aware of any specific issues that should be a focus of attention and that reviewers understand their overall responsibilities. Products that are reviewed for technical quality by external reviewers also need PDR by qualified EPA personnel.

2.2.3.2 Formal Peer Review

Formal peer reviews are conducted and documented in accordance with the Agency's Peer Review Handbook and Peer Review Policy. Historically, only a few Regional products rise to the level of peer review on an annual basis. By definition, these reviews include a charge to the reviewers that identifies their responsibilities, content areas, and specific documentation procedures.

Formal peer review is generally considered to be the highest level of technical quality review. The Office Director determines which products shall undergo formal peer review as well as what type of peer review mechanism shall be utilized (e.g. internal or external, individual or panel, etc.). Supervisors are responsible to identify to their Office Director disseminated information products that may be subject to formal peer review.

Peer review is recognized as a component of pre-dissemination review that complements and enhances the objectivity and utility of information products. Scientific and technical products that are peer reviewed also need PDR by qualified EPA Regional personnel to ensure all IQG are fully met.

2.2.3.3 Quality Assurance Review

The EPA Region 10 Quality Assurance Staff provide direct scientific and technical assistance on quality assurance matters. This assistance is provided by reviews and assessments of documents, data, and quality systems. Reviews and assessments are considered integral procedures for pre-dissemination review. Products resulting from these reviews and assessments are used in the development of other information products that may be disseminated. The products resulting from Quality Assurance reviews and assessments will contain language attesting to satisfying some of the IQG performance goals. Information products that rely upon Quality Assurance reviews and assessments can use this documentation as evidence for a quality assurance pre-dissemination review.

2.2.3.4 R10 Product Review and Web Site Policy Standard Operating Procedures

The objective of the Product Review Process is to assist staff in producing quality products that are targeted at the right audience, utilize effective graphics and layout, and deliver a message which will achieve the desired result, while reducing the potential of redundant products.

Product review covers new or significantly revised materials that have policy implications and are targeted to specific audiences (e.g. industry groups, community organizations, educators, consumers, public officials) or general public sectors, and all web pages. Product review does not cover editorial updates; fact sheets, newsletters, and leaflets; previously approved documents posted on the Internet as Adobe Acrobat (PDF) files; Legal documents, notices, and testimony; Technical material; Reports; Materials produced entirely by partners under grants, Memoranda of Agreement, and Cooperative Agreements.

Those items subject to product review are first proposed at the Concept Stage to the Product Review Officer (PRO) in ETPA with supervisor approval. If approved by the PRO, the project is added to the PROTRAC database (print products only) which notifies HQ Office of Public Affairs of the concept. The product originator will then proceed to the Draft Product Stage, and submit the draft to the PRO. Upon approval, the product originator proceeds to the Final Product Stage, and submits the final for approval.

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2.2.4 DOCUMENTATION

For formal peer review, the documentation requirements outlined in the Agency's Peer Review Handbook shall be followed. For internal management and staff information product reviews and informal external reviews, there are no additional pre-dissemination review documentation requirements beyond those documentation practices that are currently being employed by each program office. At management's discretion, on a case-by-case basis, additional documentation requirements may be established. In all cases, Agency record retention requirements are to be met.

In view of EPA IQG and PDR guidance, Regional personnel are encouraged to develop sound documentation practices to be able to retrieve review documentation. For example, creating an electronic folder to file electronic records or a hard copy file to maintain hard copy review records is advised.

As necessary, the Region may utilize the upcoming Enterprise Content Management System (ECMS) to manage PDR documentation records.

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2.2.5 DISTRIBUTING NON-EPA INFORMATION AND USE OF DISCLAIMERS

EPA sometimes provides a service to the public and regulated community by distributing information from non-EPA sources. If EPA endorses or appears to endorse the information, the IQG and PDR apply. However, if through the use of disclaimers, EPA makes it clear to recipients that the information is not EPA's information, that we are only facilitating its distribution as a public service, and do not endorse or vouch for its quality, then the IQG and PDR may not apply. This is especially important for non-EPA information that we distribute via the web.

If EPA is using non-EPA information to support an Agency position or action, or if EPA is otherwise endorsing the information, EPA is responsible for the quality of the information and the IQG and PDR apply.

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3 Personnel Qualifications and Training

Section 3 of Region 10's Quality Management Plan describes the OPM and Human Resources Office's role and responsibilities in maintaining the pool of expertise within the region and their continued commitment in providing opportunities to all staff in obtaining diversified training and enhancing individual's personal development plans. It also discusses minimum required qualification of staff involved in the areas of data collection, generation and assessment and the appropriate QA/QC associated with the procedures.

3 PERSONNEL QUALIFICATIONS AND TRAINING


Table of Contents: Section 3

  3.1 Technical Proficiency and Quality Requirements at the Organization, Program, and Project Levels
  3.2 Technical Training
  3.3 Professional Development Training
  3.4 Responsibility for Providing Regional QA Training
  3.5 Identification of Training Needs
  3.6 QAS and Technical Specialists' QA Training
  3.7 Regional QA Training
  3.8 Assessors' Qualifications And Training
  3.9 Documentation of Training
  3.10 Access to QA Information


3.1 TECHNICAL PROFICIENCY AND QUALITY REQUIREMENTS AT THE ORGANIZATION, PROGRAM, AND PROJECT LEVELS

The Human Resources Office (HRO) conducts both employment and training activities for the Region, based on expressed management and staff needs. Management defines the duties, responsibilities and required performance levels for personnel involved in environmental programs and data collection. This is to ensure that personnel have the needed academic background, training and experience to fulfill the necessary function. HRO experts then translate these requirements into the appropriate position classifications and grade levels.

In general, technical staff is hired under scientific job classifications, i.e., environmental scientists, life scientists, environmental engineer, chemist, etc. The knowledge and qualifications necessary to receive these designations are dictated by the Federal Office of Personnel Management classification standards.

The knowledge and certifications for technical personnel performing certain duties are further specified by Agency directives:

  • Compliance inspectors/field investigators (personnel who conduct field activities that may lead to or support enforcement actions) (EPA Order 3500.1)

  • Contract managers (EPA Contract Management Manual, Chapters 7 and 8)

  • Health and safety (EPA Orders 1440.2 and 1440.3)

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3.2 TECHNICAL TRAINING

Training requirements for technical staff generally are specified by Agency directives as prerequisites for certification. Supervisors may specify training for individuals on a case-by-case basis. Staff members also have individual responsibility for maintaining and expanding their qualifications. Each office has been requested to designate a training contact who organizes training to meet the program's needs. Training courses developed to comply with regional policies are generally non-technical, in areas such as cultural diversity.

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3.3 PROFESSIONAL DEVELOPMENT TRAINING

To encourage professional development beyond initial qualifications, HRO sponsors training to maintain or increase the work effectiveness of technical employees. The Regional Training Catalog identifies the following training categories:

  • Communications
  • Office of Civil Rights
  • Management Development
  • Financial & Contract Management
  • Personal & Professional Development
  • Legal & Regulatory
  • Health & Safety
  • Human Resources
  • Science & Technology
  • Information Systems

Regional management supports the belief that regular training is needed to maintain and improve performance by providing training information, and by paying costs of training taken in-house and also at external institutions. Rotational work assignments, such as the Intergovernmental Personnel Agreement Act (IPA) and career rotation programs, are also encouraged.

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3.4 RESPONSIBILITY FOR PROVIDING REGIONAL QA TRAINING

Training, although resource consuming, is a necessary component of the RQAM's responsibilities, as many of the POs/RPMs and contractors lack the experience and training to personally carry out technical duties, or are reluctant to take ownership of QA functions.

Technical specialists involved in providing training are usually those experienced in performing the function for which training is being provided (i.e., QA review, data validation, sample collection, custody and shipment, project reporting limits, analytical methods and QA oversight).

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3.5 IDENTIFICATION OF TRAINING NEEDS

The primary means for identifying training needs are through the audit process, surveys, and one-to-one discussions between the RQAM and the programs. Training priorities are jointly developed and negotiated by the RQAM and the program offices as part of the annual QAARWP development.

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3.6 QAS AND TECHNICAL SPECIALISTS' QA TRAINING

QAS and technical specialists consist of environmental scientists, chemists, engineers, and life scientists. QA Training for technical specialists is encouraged by the RQAM to keep them abreast of innovations affecting their areas of responsibility.

RQAM designated technical specialists who conduct the majority of the QA review functions or oversees the contractor's performance of those activities, become qualified primarily through previous laboratory workbench and instrumentation experience and concurrent work assignments with experienced staff members.

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3.7 REGIONAL QA TRAINING

Basic QA training is included in the 4-day Basic Inspectors Training Course required to be taken by all regional staff involved in EDCA. This training introduces the staff to the regional QA policies, QA guidance documents, the required QA-planning documents prior to data collection activities and the Regional QMP available on the Region 10 website. The RQAM and/or QAS also present QA workshops, open houses, and training as needed or upon request. In addition, a basic on-line QA training module shall be developed by the RQAM and the regional technical specialists. The RA through the QA re-commitment letter will require all regional staff to take the QA on-line training on an annual basis. The RQAM and/or QAS may provide training to Regional staff, representatives of other federal agencies, state grant recipients, and Indian tribes on QA-related topics including but not limited to:

  • Orientation to QA management
  • Preparation of QMPs, QAPP, and navigating the review and approval of these documents
  • DQO process
  • Sample collection, sample packaging and shipping, paperwork for sample collection
  • Data generation and acquisition
  • Assessment and oversight
  • Data validation and usability
  • QA oversight activities

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3.8 ASSESSORS' QUALIFICATIONS AND TRAINING

Within OEA, all assessment team members receive appropriate training prior to conducting assessments. Region 10's QA Staff have attended Quality System Training Conferences or Workshops presented by the Agency's Quality Staff and received training for management system reviews, quality system assessments and/or data quality assessment. This training is recommended for new QA Unit assessors as available. All Drinking Water Certification Officers team have successfully completed a laboratory certification course offered by NERL-CI and are all familiar with quality assurance and quality control practices necessary to support data integrity, usability and defensibility. Annual refresher training (Training Module 97.00) is conducted for drinking water program assessors prior to the first on-site evaluation of that year. Personnel conducting assessments under NELAC are required to have the appropriate NELAC training (accreditation authority evaluator or laboratory assessor). Region 10 has 4 drinking water COs and two NELAC evaluating body COs.

Quality system assessors need to have direct experience with the implementation of quality systems before conducting assessments. Similarly, personnel leading technical systems audits should have experience or familiarity with the technical procedures they are auditing. Assessors in the Environmental Services Unit have been cross-trained (e.g., both field sampling and laboratory analysis) so that in addition to their own areas of technical expertise, they are familiar with other areas as well. When resources are available, a minimum of two assessors is preferred for conducting each assessment. In addition to increasing the degree of experience, this practice increases the level of competence and helps to prevent disputes over findings. The Assessment Team Leader and the RQAM review assessment plans to ensure that the designated assessors have no direct involvement or responsibility for the work being assessed, and that there are no real or perceived conflicts of interest. In the case of peer review, assessment personnel (reviewers) are required to respond to a Conflict of Interest Inquiry to avoid any potential conflicts.

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3.9 DOCUMENTATION OF TRAINING

The Region's industrial hygienist and Health and Safety Officer and HRO are responsible for maintaining personnel training records. The effectiveness of the training is assessed by HRO's review of the course evaluation portion of the SF-182 and by the supervisor's observation of work performance. Course evaluation forms are used to provide feedback to course instructors. Training completed is documented on EPA form SF-182, which is maintained in the employee's personnel file.

In response to the Clinger-Cohen Act (41 USC 433d, in collaboration with an interagency committee, the Federal Acquisition Institute (FAI) created the Acquisition Career Management Information System (ACMIS). ACMIS is a web-accessible database system that contains training and education records of the Agencies' acquisition workforce. ACMIS is designed to assist managers to make decisions on budget, staffing and training and to allow employees to easily access and update education, training and other career information records.

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3.10 ACCESS TO QA INFORMATION

Region 10's OEA website contains a considerable amount of QA material, as well as, links to other useful QA sites. Access to Region 10's OEA website can be from the intranet for internal users, but also from the internet for outside users (i.e., contractors, PRPs, etc.) Here's the direct link to Region 10's QA webpage where a listing of QA Reference Documents, Analytical Methods, and Data Review Guidelines could be found.

The EPA Quality and Superfund Contract Laboratory Program (CLP) website also provides a wealth QA information and guidance that could be referred to during environmental measurement activity planning, implementation and evaluation.

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4 Procurement of Items and Services

Section 4 of Region 10's Quality Management Plan describes the procedures followed for obtaining services and/or items involving environmental measurements. It especially focuses on the RQAM's, CO's and COR's responsibilities in ensuring that sufficient QA/QC activities are incorporated on different levels of contracts, grants and procurement activities involving environmental measurements.


Table of Contents: Section 4

  4.1 Procurement Activities
  4.2 Procurement - Oversight of Quality


4 PROCUREMENT OF ITEMS AND SERVICES

4.1 PROCUREMENT ACTIVITIES

Region 10 has no Contracting Office or Procurement Office. However, each program office is allowed to purchase items or services < $3,000.00 obtained through the use of Government Purchase Cards. Only purchases > $3,000.00 require Purchase Requisition (PR) Forms (1900-8) that are prepared and approved by the regional Program Managers with program funds committed to by the Funding Control Officers (FCOs). These PRs are approved and processed by Region 7 Contracting Officer(s).

All EPA purchases must meet established administrative and QA requirements. The Office of Personnel Management (OPM) is responsible for ensuring that all procured items and services meet established requirements and perform as specified. Procurement documents or financial assistance agreements require suppliers to have a Quality System, consistent with EPA QA requirements, if the supplier is providing services or items that directly affect the quality of results or products for environmental programs. Contractors, suppliers and financial assistance recipients are responsible for the quality of work performed or items and services provided by their subcontractors and suppliers.

4.1.1 CONTRACTS INVOLVING ENVIRONMENTAL DATA COLLECTION ACTIVITIES

During the contract pre-award phase, the originating program office through the project Contract Officer Representative (CORs) shall notify the RQAM of all contracts involving environmental data collection. Normally, the types of contracts which will require the generation of quality assurance documentation are those in which services are procured. Examples of these types of service contracts include contractor analytical operations, sampling/field measurements, data assessment, site investigations, etc. The QA requirements in the Federal Acquisition Regulations (FAR) 46.202-4 and FAR 52.246-11 (Higher-Level Contract Quality Requirement, Feb 1999) apply to regional contracts involving the collection and use of environmental data. The appropriate project and contracting officer (PO and CO) are responsible for ensuring that all solicitations for work involving environmentally-related measurements meet the Higher Level Quality Requirements specified in FAR 52.246-11. The COR shall ensure that a QA Review Form has been completed in accordance with EPA Order 1900, the Contracts Management Manual. The COR is also responsible for including the RQAM as a technical evaluation panel member on those contracts with a value of $500,000 or greater, if the contracts involve environmental measurements or technology.

It is the responsibility of the project COR and program office to ensure that QA Review (QAR) Forms, for each procurement request/order, except for incremental funding actions, when the acquisition is in excess of $25,000, with appropriate signatures, are included in every solicitation package. The QAR Form will specify if environmentally-related measurements are required under the contract's scope of work, and if so, which type of quality documentation is required under the contract. The default submissions for contracts requiring environmental measurements are a Quality Management Plan (QMP) before award and a Quality Assurance Project Plan (QAPP) for each applicable project after award. The QMP and QAPP may be combined into a single quality assurance document if agreed to before contract award by the contract PO and the RQAM. Prior to contract award, the program office shall ensure that QMPs and QAPPs are reviewed and approved by the RQAM for those contracts requiring environmental measurements or technology.

Details on QA requirements for contracts and solicitations involving measurement activities can be found in the following Contract Quality Requirements webpage.

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4.1.2 GRANTS AND FINANCIAL ASSISTANCE AGREEMENTS INVOLVING DATA COLLECTION ACTIVITIES

Region 10, as do most Regions, provides financial assistance to States, Tribes, Locals and non-profit organizations who assist the Agency in carrying out its mission. For projects involving environmental programs, EPA assistance agreement recipients must implement or have implemented a quality system conforming to the American National Standard ANSI/ASQC E4-1994, “Specifications and Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology Programs.” This quality system shall be applied to all environmental programs within the scope of the assistance agreement. Environmental programs include direct measurements or data generation, environmental modeling, compilation of data from literature or electronic media, and data supporting the design, construction, and operation of environmental technology. This requirement is consistent with and for all environmental programs operating under the EPA Quality System.

It is the Grant's Office and PO's responsibility to ensure that QA Review (QAR) Forms with appropriate signatures are included in each grant application packet involving data collection activities. The grantee, the PO and the RQAM work together to determine when the preparation of QA Planning documents are required. These QA documents are submitted by the grantee to the PO. The PO is responsible for ensuring that the QA planning documents submitted are adequate in meeting the Program goals and objectives. The document is then forwarded to the RQAM for QA review and approval/disapproval. Once the RQAM completes the review and approval of the planning document, immediate oversight responsibilities are transferred with the PO, Task Monitor or the WAM. For a more detailed information regarding QA requirements for EPA grants please refer to the Grants and Debarment webpage.

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4.2 PROCUREMENT - OVERSIGHT OF QUALITY

4.2.1 COR's Responsibilities

Please refer to section 1.4.4 of this QMP.

4.2.2 RQAM Responsibilities or Authorized Representative

Note: These responsibilities apply to QA Managers, QA Coordinators, QA Directors, and other authorized representatives. Authorizations are documented in each organization's Agency-approved Quality Management Plan.

  • For all solicitations, the QA Manager must review the Statement of Work and the completed QA Review Form to ensure that quality-related requirements are appropriately addressed and are consistent with the organization's Quality Management Plan, and then sign the QA Review Form.


  • If quality-related documentation or activities are required for a solicitation or a Statement of Work under a multiple award contract, and (a) the potential value of the procurement exceeds $500,000, or (b) the estimate of the percentage of costs or level-of-effort allocated to activities requiring quality requirements exceeds 15%, or (c) procedures defined in the Agency-approved Quality Management Plan of the organization sponsoring the work apply, then the QA Manager must:

    • Assist the COR with the development of the Technical Evaluation Criteria, and any associated technical instructions, for the Request for Proposal, and
    • Serve as a member of the Technical Evaluation Panel (when convened) for the purpose of evaluating the QA aspects of the technical proposals.

  • After award of the contract, the QA Manager must review each subsequent Statement of Work under the contract and the completed QA Review Form to ensure that quality-related requirements are addressed and are consistent with the organization's Quality Management Plan.


  • Both before and after award of the contract, the QA Manager must perform any additional responsibilities defined in his or her organization's Quality Management Plan (such as reviewing and approving quality documentation or ensuring that the organization's QMP is being implemented).


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5 Document and Records

Section 5 of the Region 10 Quality Management Plan describes the procedures in handling and management of both paper and electronic documents and records generated during environmental measurement activities and the staff that are responsible for their upkeep, maintenance, retention and eventual transfer to the Federal Record Center and the required documentation for each process. It also describes the different types of in-house databases used by the Region for environmental monitoring and work tracking purposes.


Table of Contents: Section 5

  5.1 Quality Related Documents and Records
  5.2 Region 10 QA Tracking System
  5.3 RSCC Electronic Tracking System
  5.4 QA Document Review Tracking System
  5.5 ASB CLP Tracking Systems
  5.6 Sample Documentation


5 DOCUMENT AND RECORDS

The Federal Records Act of 1950, as amended, requires all federal agencies to make and preserve records containing adequate and proper documentation of their organization, function, policies, decisions, procedures, and essential transactions. These records are public property and must be managed according to applicable laws and regulations.

All records and documents used in administering this Quality Management Plan and conducting environmental data operations and environmental technologies must be managed according to federal laws and regulations and EPA policy and guidance. Records are managed as an Agency asset throughout their life cycle, which consists of three basic stages: creation, active maintenance and use, and disposition. The records life cycle is initiated by the creation, collection, or receipt of records in the form of data or documents in the course of carrying out EPA's administrative and programmatic responsibilities. The life cycle continues through the processing and active use of the information in the record, until the record is determined to be inactive. The final step in the life cycles is disposition which frequently includes transfer to inactive storage, followed by transfer to the National Archives or destruction.

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

The Region 10 Records Management Program intranet site for EPA staff provides a records management manual, standard operating procedures, training modules, framework, retention schedules and program contacts to provide records storage and timely retrieval, secure storage and preservation of sensitive records, minimize potential loss or damage to records, and provide cost effective use of available storage space. It is also linked to the new Enterprise Content Management System (ECMS), an electronic standardized recordkeeping system that will improve records management at EPA and make records retrieval and information sharing easier and less time consuming.

5.1 QUALITY RELATED DOCUMENTS AND RECORDS

QA-related records and documentation are comprised of the products generated from the following QA activities and document: Management System Reviews, Technical System Audits, Data Audits, QAPPs, SOPs, QMPs, Data Review and Validation Reports and Superfund CLP Laboratory Data and Data Assessment results.

Each Program Office is the custodian of its own quality-related documents and records pertaining to environmental data operations. OEA's QA Records Management Procedures SOP identifies the policies and procedures for implementing OEA'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.

While undergoing data validation process, all original hard copy of the CLP- generated data and courtesy copies of QA documents submitted by the programs for review and approval are filed and stored in locked file cabinets on the 9th floor (which is accessible by employees/contractors with key card access to the floor) for a period of up to 6 months or until the site specific project had been completed. After the project has been completed, and program authorization has been obtained, the CLP-generated analytical data and review documents are transferred to the Superfund Records Center for filing and then eventually transferred to the Federal Records Center (FRC). The establishment and routine use of filing systems and security procedures for the programs are the responsibility of the Regional Program Offices. The documents are maintained in a manner ensuring compliance with all applicable statutory, regulatory and EPA requirements for documents and records, i.e., EPA Order 2160 (EPA 1984) and the EPA Directive 2100, Chapter 10 (EPA 1998) by the QA staff and the RQAM. Detailed SOPs on requesting record for review, retention and transfer of records to the Superfund Records Center and/or Federal Record Center can be found in the Region 10 Superfund Records Center Web page.

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5.2 REGION 10 QA TRACKING SYSTEM

The QA program uses three tracking systems in monitoring and maintaining electronic data files and information regarding sample analysis requests, QA workload and receipt of data deliverables from the laboratories. The sample analysis and submitted deliverables database is located in the QA user share drive and maintained by Region 10 RSCC, the sample analysis request database, the SDG tracking system, was created and maintained by the Sample Management Office (SMO) in ASB and the QA workload tracking is maintained by the RQAM and the QAS.

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5.3 RSCC ELECTRONIC TRACKING SYSTEM

The RSCC electronic data tracking system is a relational ACCESS database system created, maintained and modified, as needed, by the RSCC. The system is stored under the RSCC subdirectory of the QA directory. This system is purely a tracking system for CLP data packages received in the region and summary information for samples scheduled for analysis with the EPA Region 10 Laboratory or for subcontracting. The system does not contain environmental data.

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5.4 QA DOCUMENT REVIEW TRACKING SYSTEM

For tracking QA documents submitted to the RQAM for review and approval, the RQAM utilizes the QA Workload tracking system. The project requests are logged-in by the RQAM or assigned staff with the expected deliverables, estimated level of effort (man-hours) and the estimated date of completion. At the end of each fiscal year, the number of QAPPs reviewed and the data validations completed are summed up using the tracking system. These numbers are reported in the QAARWP.

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5.5 ASB CLP TRACKING SYSTEMS

ASB has the following tracking databases that are also used by regions to keep track of their Superfund analytical services requests and data packages. The tracking systems are: (1) Analytical Services Tracking System (ANSETS) is a web-based database that keeps track of each Region's Superfund analytical services that were sub-contracted to commercial laboratories, (2) Superfund Project Request System (SUPRS) is a web-based database that allows users to manage the sample request and scheduling process based on their roles, responsibilities, and assigned user privileges. SUPRS allows user to perform the following tasks (users who perform the task are indicated in the parentheses): create, update, and submit requests for analytical services (Regions); assign and notify laboratories and regional personnel of a laboratory's assignment (SMO); verify the accuracy of site data (SMO and Regions); and confirm acceptance of an assignment to perform analytical services (laboratories), (3) Sample Delivery Group (SDG) Tracking System (STS) (password protected site) is also a web0based tracking system that keeps the Regional POs, RSCCs, and the other CLP community of the status of the submission of the analytical data from the CLP laboratories, and (4) Web-based Invoicing System (WIS) was designed to permit authorized CLP laboratories to generate and submit invoices via the Internet. This Internet-based solution has minimum startup costs for the laboratories, requiring only a low-end computer, Internet access, and a Web browser. Encryption and authentication techniques have been incorporated to ensure secure transmission of confidential and sensitive invoice information over the Internet.

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5.6 SAMPLE DOCUMENTATION


Table of Contents: Section 5.6

    5.6.1 Sample Numbers
    5.6.2 FORMS II Lite
    5.6.3 MEL Sample Traffic Report/Chain-of Custody (TR/COC) Form
    5.6.4 Sample Tags and Custody Seals
    5.6.5 Control of QA Guidance Documents


5.6.1 SAMPLE NUMBERS

EPA CLP sample numbers are issued by SMO to the RSCC after the laboratory has been assigned to the project. The RSCC supplies the laboratory assignment, address, lab contact person, sample shipment instructions and sample numbers to the EPA Project Manager and the field sample collection PM. For in-house tracking, the RSCC also issues and keeps tract of the Region 10 sample tracking numbers issued in increments of 50 samples per project starting with the year as the first two number and the weeks of sample for the third and fourth number and then the four digit sample numbers. Sample collection team may use the Forms II Lite or the Region 10 MEL traffic report/chain of custody form during sampling.

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5.6.2 FORMS II LITE

All samples that are scheduled for analysis via the Superfund CLP laboratories are required to use the Field Operations and Records Management System (FORMS) II Lite software for chain-of custody (COCs). The FORMS II Lite software is a flexible and easy-to-use, stand-alone, Windows-based application that simplifies and accelerates the sample documentation process. FORMS II Lite reduces the generation of hand written documents by nearly 70 percent. Specifically, FORMS II Lite: generates sample labels, bottle tags, and Chain of Custody (COC) forms; tracks samples from the field to the laboratory; facilitates electronic capture of sample information into databases; and exports data electronically as .xml, .dbf, or .txt files. Here's the link to the FORMS II Lite website.

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5.6.3 MEL SAMPLE TRAFFIC REPORT/CHAIN-OF CUSTODY (TR/COC) FORM

The Region 10 personnel collecting samples for measurement activities have the option to use the FORMS II Lite or the MEL TR/COC Form to keep track of the samples and sampling information both of which could be obtained from the RSCC. In the absence of the FORMS II Lite and the MEL TR/COC forms, the samplers may use the COC provided by the laboratory where the samples will be sent for analysis. This usually happens when the samples are scheduled to be sub-contracted to a commercial lab.

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5.6.4 SAMPLE TAGS AND CUSTODY SEALS

Unless the samples collected are for enforcement, sample tags are no longer required for each sample container collected. This will minimize mistakes in the field and will allow the field crew to focus on the maintenance of the COCs and reconciliation of sample bottles with the sample collection documentation. When needed, sample tags can be obtained from the RSCC prior to mobilization to the site. The use of custody seals are still required by the region. Due to the latest developments in security and sample processing at the laboratory, custody seals per sample are no longer required. Custody seals are usually affixed on the lid and sides of the coolers to monitor cooler custody tampering during sample shipment.

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5.6.5 CONTROL OF QA GUIDANCE DOCUMENTS

QA guidance documents are developed for Regional use by the RQAM and technical specialists in the absence of Agency-wide guidance, or when detailed Regional processes need to be documented. Examples include Regional Guidance for Data Deliverables for CLP and non-CLP laboratory data packages, Region 10 Data Review Guidelines and Generic QAPP for Program Compliance Inspections, Filed and Laboratory Standard Operating Procedures (SOPs) and Modified Analysis Statement of Work (MA SOWs) for Organic and Inorganic Analyses for the CLP Lab. The regional guidance is readily accessible at the Region 10 QA web site.

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6 Computer Hardware and Software

Section 6 of Region 10's Quality Management Plan is describes the responsibilities of the group accountable for the management of the information technology infrastructure and reliable electronic information products within the region.


Table of Contents: Section 6

  6.1 IRU Roles and Responsibilities
  6.2 Regional Information Management Systems
  6.3 Hardware and Software Requirements
  6.4 Data Standards


6 COMPUTER HARDWARE AND SOFTWARE

EPA's ability to fulfill its mission is dependent upon a strong information technology infrastructure and reliable electronic information products. These must be able to support a broad range of mission objectives; all of which require information integration and dynamic communication among EPA offices and its partners.

OEI is responsible for managing the Agency's information functions, including information collection, technology infrastructure, and access. In that role, OEI has established information technology (IT) standards to ensure that information technology components integrate properly into the overall IT infrastructure. It has also developed information product standards to ensure that information deliverables can be readily integrated and used for a varied range of uses. The Region conforms to OEI's IT standards.

6.1 IRU ROLES AND RESPONSIBILITIES

Information Resources Unit of the Office of Management Programs (OMP) has the primary responsibility for setting policy and guidance for the management and development of computer-related program support in Region 10. The Director of this Office directs the Information Resources Unit (IRU) responsible for the Local Area Network, Geographic Information Systems, database management, information security, personal computing and information access, application development, desktop support, training, and records management. Personal Computing/Local Area Network coordinators in each Office act as liaisons between IRU and their office co-workers. The IRU is responsible for the following computer hardware and software support activities:

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


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


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


  • Coordinating system software and hardware changes for PC equipment


  • Troubleshooting and fixing software and hardware problems reported by users


  • Overseeing PC and LAN security


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


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

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6.2 REGIONAL INFORMATION MANAGEMENT SYSTEMS

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

It is Regional policy to work closely with Regional information system customers, as well as OEI and national program offices as appropriate, on all phases of system development, improvements, and updates, including contractor developed and other entity developed systems. During all life cycle phases of information management systems, the Region will comply with requirements within EPA Directive 2100, Information Resources Management Policy Manual, the Interim Agency System Life Cycle Management Policy (PDF)(13pp, 229K) and Interim Agency System Life Cycle Management Procedure (PDF)(94pp, 4.65MB). Compliance with the applicable information resource management standards will ensure that all hardware and software configurations are developed, installed, and tested prior to use, to guarantee they perform as expected, are well documented, and meet user requirements.

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6.3 HARDWARE AND SOFTWARE REQUIREMENTS

The Region conforms to the System Design and Development Guidance and Operations and Maintenance Manual and the Delegation of Procurement Authority Guide. This ensures that purchased hardware and software will meet user requirements and will conform to OEI's technology and procurement guidelines. Other pertinent hardware and software standards utilized by the Region include: EPA's Network Security guidelines, Energy Star and Section 508 guidelines, and EPA's Hardware and Software Standards Roadmap.

The Information Technology Policies and Processes intranet site for EPA staff also provides a comprehensive process followed by Region 10 staff when procuring computer hardware and software on a short-, medium- and long term priority scale. General information on information security, data access, confidential data and roles and responsibilities of each Region 10 employee are explicitly discussed in the Information Security intranet site.

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6.4 DATA STANDARDS

All federal agencies are required to adhere to federally mandated data standards and regulations. It is the policy of the Region to comply with all applicable regulations, guidance, executive orders, and internal policy documents concerning data standards. These include EPA's core information data standards: the Locational Data Accuracy Standard, the Facility Identification Standard, the Groundwater Data Element Standard, the Chemical Abstract Number Standard, and the Electronic Transmission of Lab Measurements Standard. It is the responsibility of individual Offices within the Region to be aware of the current standards and regulations. These standards and polices can be found at http://www.epa.gov/irmpoli8/. Other relevant data product standards include: standards for web product development contained in the EPA Web Guide and two related EPA Orders: 2190.1 Cookies and other User Tracking Methods and 2190.2 Children's Privacy and Copyright Issues.

Some of the program offices have their own database administrators who coordinate activities relating to their associated databases. Since these databases are national databases, requirements are defined by the national program offices at HQ. Regional data are collected, processed, and managed by the program offices. IRU manages the hardware, software and networking platforms. IRU also coordinates with the program offices on hardware and software issues, purchases and upgrades, and pilot programs.

The Region 10 Information Technology intranet site for EPA employees contains more information regarding Region 10's information technology strategic plans, roles and responsibilities, policies, security, resource management and projects.

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7 Quality Planning

Section 7 of Region 10's Quality Management Plan describes the management of QA resources and planning procedures used within the region.


Table of Contents: Section 7

  7.1 Management of Systematic Planning
  7.2 Systematic Planning Process
  7.3 Use of Existing Data


7 QUALITY PLANNING

7.1 MANAGEMENT OF SYSTEMATIC PLANNING

The primary vehicles for annual planning in the Region are the budget process, GPRA and the State/EPA Agreement process. Depending on the sensitivity and level of work that may be involved, sites are prioritized by the RA/DRA. The DRA allocates resources to each office for the management and operation of specific programs, based on the Region's anticipated budget. Program managers balance their available resources with their projected need for support, e.g., QA and technical support from OEA and other Regional Offices to meet GPRA and program goals and commitments. Programs' full time employee (FTE) distribution (in terms of man-hours) in the Region's Technical Support Offices are revisited and negotiated. Acceptance of the program's proposal for FTE distribution results in work commitments.

Most regional work activities are mandated by policy guidance, congressional initiatives, commitments to HQ, and Program Office Work Projection Plan (WPP) prepared by each Program Office prior to the start of a fiscal year. It contains estimates of the work activities for that year. Ideally, the WPP is developed in consultation with the Program Offices' technical support offices. The RQAM seeks input from the offices it supports in preparing the QAARWP prepared for each fiscal year.

7.2 SYSTEMATIC PLANNING PROCESS

All program and project managers are responsible for (1) specifying, prior to the initiation of data collection and/or usage, their data quality needs; (2) providing adequate resources to ensure that the needs will be satisfied; and, (3) ensuring that the quality control and quality assurance requirements are written and satisfied for all environmental data collection activities (EDCAs). This includes modeling projects and the use of historical data for decision making purposes. All personnel involved with EDCAs, including field, laboratory, project and data processing personnel, as well as, grant and contract officers, have the responsibility for ensuring the quality of the data associated with those measurements.

For new data collection activities, it is Region 10’s policy that high level decision makers use a systematic planning process, i.e. the data quality objectives (DQOs) process, as a mechanism for balancing conflicting demands and data quality needs to ensure that environmental monitoring will effectively support decision making. DQOs are qualitative and quantitative statements that define the type, quality, and quantity of data necessary to support defensible environmental management decision-making. The DQOs are developed before data are collected and consist of the following 7 steps: (1) description of the problem, (2) identification of the decision needed to solve the problem, (3) identification of the information and measurements needed to support the decision, (4) condition specifications (5) definition of the conditions which the decision maker will choose among alternative actions, (6) specifications of acceptable limits on decision error and (7) evaluation of the results of the 6 previous steps and develop the most resource efficient design for data collection that meets all DQOs. The DQO systematic planning process ensures that adequate and appropriate data will be collected to support project needs.

Region 10 also uses the project teaming approach when planning and implementing projects for all programs. During the planning phase of the project, the project team, comprised mostly of the technical staff from OEA, and the clients, i.e., program PMs, CORs, contractors and stakeholders, meet regularly to discuss concerns and issues related to project goals, schedule and milestones, roles and responsibilities, logistic needs, project data objectives, measurement objectives, data needs, measurement and data performance criteria and specifications, QA/QC requirements and criteria, sources of data – primary or secondary and criteria for data usability. Project decisions are reached through a general consensus of the project team members. Regional managers make decisions based on information provided by the technical advisory committees and by regulatory requirements. Development of performance acceptance criteria is a normal part of the planning process and accomplished based on cost-effectiveness and realistic capabilities of the measurement process. The results of the DQO process are documented in the QA Project Plan. EPA developed the following documents for the DQO process: Guidance for the Data Quality Objectives Process (PDF)(121pp, 1.6 MB),” G-4, EPA/600/R-96/055, February 2006, or Data Quality Objective Process for Hazardous Waste Site Investigations, EPA QA/G4HW(PDF)(143pp, 599K),” January 2000 or most recent version, depending on the program involved.

7.3 USE OF EXISTING DATA

Before QA concerns are identified, the project team shall first establish the intended use of the data. This will determine the criteria that will be used to assess the quality of the data. Existing data that will be used for screening purposes do not require stringent QA requirements. A more robust data quality assessment will be needed for data that will be used to support decision making and at a minimum may need the following documents associated with the data: chain of custody, QA Project Plan, QC Narrative or Data Validation Report, QA/QC report and laboratory analytical data report. It is Region 10's QA policy to conduct data quality assessment of existing data (secondary data), prior to another project’s intended use. The region follows the EPA guidance document on data assessment, Data Quality Assessment: A Reviewer's Guide (PDF)(61pp, 258K),” EPA QA/G9R, February 2006. The EPA Quality website provides a list of useful tools that can be used for the assessment of secondary data.

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8 Implementation of Work Processes

Section 8 of Region 10's Quality Management Plan describes the QA workflow processes.


Table of Contents: Section 8

  8.1 RQAM Workflow and Tracking Process
  8.2 When is a QAPP Required?
  8.3 QAPP/QMP Review Process


8 IMPLEMENTATION OF WORK PROCESSES

8.1 RQAM WORKFLOW AND TRACKING PROCESS

The Regional Project Officers/Regional Project Managers in Region 10 shall follow the following workflow process when requesting technical support for the review and approval of QA documents:

  • The need for QA support is identified by the program and the designated Project Officer or Project Manager (referred to as the “requester”).


  • A formal request for a need for technical QA support is made by the requester to the Environmental Services Unit Manager and cc the RQAM using the OEA tech support tracking system. If the QA staff supporting the site, project, or program is known or has been previously designated (referred to as “designated QA staff”), that person will be copied with the formal request. If available in electronic format, the documents for review are also attached by the requester to the formal request. The work request will specify the following:


    • Name of the site or project
    • Site account number or regional office/program being supported
    • Type of QA support needed
    • Completion due date
    • Level of effort required


  • Depending on the designated staff's current workload and commitments, the designated staff will respond to the requester, discuss due dates and deliverables with copies sent to the RQAM and his/her Unit Manager. Once an agreement has been reached between the designated staff and the requester, the QA staff's manager will formally accept the work request in the OEA tracking data base. The designated QA staff designated staff will enter the work request into the in-house web-based QA workload tracking system.


  • If the site or project is new and the QA document is not available in electronic format the requester will submit the hard copy document to the RQAM.


  • The RQAM checks with the appropriate Unit Manager regarding the availability of the requested expertise, the presence of any conflicts of interest, and the current workload of the affected staff/Unit. If the staff's workload capacity is full, the RQAM, requesting official, and Unit Manager will re-prioritize the work request and re-assign the request to the appropriate Unit staff.


  • If the site or project is highly sensitive, requiring fast turnaround completion time and high level of effort, the requester shall meet with the RQAM and the corresponding Unit Manager to discuss the details of the work that is requested and the rationale for the level of effort and fast turn around time.


  • For new sites or projects with regular turn around times (3-4 weeks), the RQAM enters the work request into the QA tracking system as unassigned work and communicates with the Units for the need for technical support. Once the work request has been entered in the QA workload tracking system, a tracking number or File ID is assigned automatically. It is incumbent upon the staff to check the status of the unassigned work request and check for availability of support. The RQAM meets regularly with the technical QA staff and keeps them informed of the workload status.


  • The staff member accepting the work becomes the designated staff and goes to the QA tracking system entering their name as the expert assigned and changes the status of the work request.


  • If no unresolved problems are encountered and the work is completed by the due date, the product is submitted to the requester with a copy sent to the RQAM and the work status changed in the QA tracking system as “closed” by the designated staff. The RQAM or the RQAM designee approves the product and returns the work product to the requestor. If the document is not approvable, the designated staff sends his/her comments and/or recommendations to the requester. The designated QA staff and the requester continually work together during review and revision process until the document has been finally approved.


  • If problems occur that will prevent the designated staff from completing the work by the required due date, the requestor will be informed by the designated staff or the RQAM to establish a new due date.


If an agreement on the new due date can not be reached, the requester will consult with the designated staff's Unit Manager for resolution. The Unit Manager and RQAM will either re-assign the work request to another technical staff member or change the priorities of the designated staff to meet the new due date. The work request entry to the OEA tech support tracking system is revised as necessary to reflect the new work request, work assignment, and due date. A Schematic Diagram for the QA Workflow and Tracking is in Appendix A of this QMP.

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8.2 WHEN IS A QAPP REQUIRED?

A QAPP is a required planning document for all projects that involve the generation and/or use of environmental information - generally called 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 and they are:

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 and in the UFP QAPP Guidance - Subsection 2.7 at http://www.epa.gov/fedfac/pdf/ufp_qapp_v1_0305.pdf (PDF)(177pp, 1.6 MB) page 74).

Modeling Projects, some projects utilize models or mathematical algorithms for inferring or predicting an environmental condition. 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 http://www.epa.gov/quality/qs-docs/g5m-final.pdf (PDF)(121pp, 615K) 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 how it should be developed. Region 10 has modeling experts and technical specialists that handle the review of modeling QAPPs.

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 (PDF)(106pp, 1.4 MB) 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 10 GIS Team.

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8.3 QAPP/QMP REVIEW PROCESS

The QAPP integrates all technical and quality aspects of a project, including planning, implementation, and assessment. The function of the QAPP is to document planning results for environmental data operations and to provide a project-specific “blueprint” for obtaining the type and quality of environmental data needed for a specific decision or use.

The QAPP shall be prepared in accordance with the (UFP-QAPP) guidance www.epa.gov/fedfac/documents/qualityassurance.htm for regulated or clean-up facilities or the most current version of the EPA Requirements for Quality Assurance Project Plans (PDF)(40pp, 87K), EPA QA/R5 March 2001.

It is the PO's, PM's or COR's responsibility to submit the QAPP to the RQAM for review and approval. For reviews that will entail more than 8 hours estimated level of effort, the work request is entered by the PM/PO/COR into the OEA tracking database. For timekeeping and accounting purposes, the work request is routed to the PM/PO/COR's immediate supervisor for approval. The RQAM initially reviews the document needing a review and confers with the QAS' and technical specialist's immediate supervisor for FTE availability. Once a turn around time has been agreed upon by all parties, i.e., the requestor, the program supervisors, the assigned QAS/technical specialist and the RQAM, the review process then commence. Only the RQAM is authorized to approve QMPs. The QAS has the RQAM delegated authority to approve QAPPs. The PM/PO/COR and the RQAM or the designated QAS are the approving authorities for QAPPs. No environmental measurement activity could occur in the region without an EPA approved QAPP. A detailed schematic diagram of the QAPP/QMP review process is in Appendix A.

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9 Assessment and Response

Section 9 of Region 10's Quality Management Plan describes the procedures used by the QA staff when conducting field, laboratory and data assessments, the required planning, reporting and follow-up documents and handling of special circumstances like conflict of interest.


Table of Contents: Section 9

  9.1 Assessment Procedures
  9.2 Assessment Programs
  9.3 Response Procedures
  9.4 Corrective Actions
  9.5 Quality Improvement Process
  9.6 Effective QSRs and TSRs Conducted by RQAM
  9.7 QSRs Conducted by Quality Staff (OEI)


9 ASSESSMENT AND RESPONSE

9.1 ASSESSMENT PROCEDURES

All environmental measurement activities require a mechanism for monitoring the effectiveness and adequacy of the QA measures integrated into the program. The standard oversight mechanisms used by the Region for Quality System Assessments are: (1) quality assessment review/audit (2) technical assessment review/audits (3) data verification and validation and (4) data assessment. Each type of review follows EPA specified planning, implementation and evaluation procedures as documented in the following guidance: Guidance on Assessing Quality Systems (EPA QA/G-3)(PDF)(83pp, 555K),” March 2003; “Guidance on technical Audits and related Assessments for Environmental Data Operations, (EPA QA/G-7),” May 2006; “Guidance on Environmental Data Verification and Data Validation, (EPA QA/ G-8)(PDF)(96pp, 387),” January 2008, “Data Quality Assessment, A Reviewer's Guide (PDF)(61pp, 259K),” EPA QA/G9R, February 2006; “Data Quality Assessment; Statistical Methods for Practitioners (PDF)(198pp, 2.3 MB),” EPA QA/ G9S, February 2006, and the “2003 NELAC Standard, EPA/600/R04-003 (PDF)(324pp, 2.4 MB).”

Overall, the outcome of the assessment is expected to: (1) identify strengths and weaknesses, (2) cause corrective actions to be taken to alleviate problems, (3) facilitate the initiation of changes to enhance the QA program, (4) serve as a vehicle for providing technical assistance, (5) enhance awareness and understanding of QA/QC policies and procedures and (6) provide a measurement of the effectiveness of QC in assuring the quality of data.

The qualifications and responsibilities of the assessors are discussed in section 3.8 of this QMP.

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9.2 ASSESSMENT PROGRAMS

9.2.1 SUPERFUND'S CONTRACT LABORATORY ASSESSMENT PROGRAM

The Superfund Contract Laboratory Program (CLP) is a national contracting vehicle for analytical services needed by the Superfund program. Currently, the CLP program has six analytical services contracts and maintains the accreditation of about 25 laboratories. To maintain accreditation and good contract standing, each of the laboratories are required to pass the Quarterly Blind Performance Evaluation Samples (QB-PES), quarterly data assessment and an annual on-site audit. Region 10 is committed to support the CLP by providing a Project Officer (PO) and a Regional Sample Control Coordinator (RSCC). The qualifications and responsibilities of the CLP POs are specified in the CLP website. PO with the QATS auditor is required to conduct an annual technical system audit of the laboratory(s) located within the region. The CLP PO and the QATS auditor follow the stringent CLP on-site audit checklist and SOP and the contractual requirements set forth by the contract’s Statement of Work. The Region 10 CLP PO may also be requested by HQ to conduct TSA’s on other CLP laboratories located in other regions. Assessment procedures include 60 day planning (prior to on-site site), review of documents, coordination (30 days), preparation of additional audit questionnaires, on-site evaluation, preparation of draft report, reconciliation of audit report and submission of final report.

9.2.2 NELAP CERTIFICATION/RE-CERTIFICATION ASSESSMENTS

Region 10 is committed to support the National Environmental Laboratory Accreditation Program, commonly known as NELAP. Region 10 provides Certification Officers that participate during the certification or re-certification of Accreditation Body (AB) located within the geographical boundaries of the region. Currently, Region 10 has only one AB, i.e., Oregon Laboratory Accreditation Program (ORLAP). NELAP has very stringent and proprietary SOPs for laboratory certification and accreditation. For AB certification, three assessments are performed: (1) data completion, (2) on-site evaluation and (3) assessment observation/evaluation. The qualifications, roles and responsibilities of COs, assessment checklist and SOPs are specified in the most current approved version of the NELAC Standard (PDF)(324pp, 2.4 MB).

9.2.3 SAFE DRINKING WATER ACT (SDWA) ACCREDITATION PROGRAM

Currently, Region 10 has four SDWA Certification Officers for organics, inorganics, and microbiology analyses. The SDWA program is very prescriptive in nature and follows the requirements, procedures, schedules and timelines specified in the 40CFR. During assessments, the capability and capacity of the State laboratories are assessed to retain primacy and maintain proficiency in the accreditation of commercial laboratories for drinking water analyses.

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9.3 RESPONSE PROCEDURES

Assessments conducted under the Assessment Program must, by definition, produce a written report which summarizes the assessment, and states the findings, observations and recommendations for response actions. Without documentation in a final report, a review or evaluation is not considered an assessment.

The objective of the report is to communicate assessment results to the responsible level of management of the organization being assessed. Efficient communication of results allows management to implement timely, effective response actions so that the quality objectives can be met. Quality system assessments are typically reported to senior managers of the organization responsible for the work. Assessments of project activities are reported to the EPA Project Manager. Copies of reports for internal assessments of project activities conducted by Lead Organizations also are sent to the EPA Project Manager. The EPA Project Manager may request a review of an audit report by the QA Staff. Senior managers of the assessed organization are responsible for ensuring that any deficiencies found in quality system assessments are appropriately addressed. Project Officers and Project Managers are responsible for ensuring that findings from assessments of project activities are appropriately addressed.

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9.4 CORRECTIVE ACTIONS

The process for corrective action is the response to the findings of an assessment. The authority of the RQAM is relied upon by the programs and regional partners to point out the necessary corrective actions needed to address any QA vulnerability that may arise in environmental data collection activities conducted in Region 10, external agreements, regulatory processes, or day-to-day operations (e.g., use of non-approved methods for Clean Water Act compliance monitoring by a State program). If the RQAM and assessment team identify vulnerabilities through the audit processes, these vulnerabilities will need to be addressed by the respective office or organization audited. The RQAM will follow-up with the respective office or organization to ensure that a corrective action plan is developed and implemented by the office or organization to correct and/or resolve the vulnerability addressed in the audit report. Follow-up is performed by the RQAM or designee with the organization to ensure that the resolution reached has been implemented.

Essentially, the principal responsibility for the implementation of response/corrective action is that of the assessed organization. A written response is provided by the assessed organization for all assessment findings with objective evidence of the effectiveness of the correction, and with specified time frames for those actions in progress or planned for the future. For project activities, copies of all corrective action response letters and corrective action forms should be included as attachments to the QA Management Reports and included in the Final Project Report.

The authority and responsibility for verifying the timeliness and effectiveness of corrective action resides with the senior management ultimately responsible for the work that was assessed. The responsible senior manager or the RQAM may request the assessors who conducted the assessment to verify the effective implementation of corrective actions. Assessment follow up is documented and reported using the same process as the original assessment.

Where QA concerns remain unaddressed, the RQAM may elevate the vulnerability to an OD as discussed in Section 1.6 of this QMP.

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9.5 QUALITY IMPROVEMENT PROCESS

QA implementation is a continuous improvement process. It is the responsibility of the program managers to ensure staff participation in all program reviews and to annually review all QA activities of their program and staff, e.g., DQOs and QAPPs are developed and approved in advance of project start-up, project –specific SOPs are in place and revised if necessary, and DQAs are conducted at the end of the project. All deviations and discrepancies noted during any independent or self-assessment review will be corrected promptly and modifications made, if necessary.

As an added activity for quality improvement process, routine contractor on-site evaluations are also performed by QAS to minimize errors, at the start of each sampling season, (March –May) each year. Field and laboratory on-site evaluations are conducted to determine the efficiency and technical proficiency of the contracted staff assigned to implement the projects. Each of the contractors is evaluated. The EPA approved site specific QAPP and the SOPs are used as a basis for the evaluation. Deviations from the set procedures and specifications of the QAPP are noted. Mistakes, poor techniques, documentation weaknesses as well as good practices are identified and noted. A report addressed to the PM is written by the QAS within 7 days after the on-site evaluation. The evaluation process determines techniques that could be improved, weaknesses and errors that could be eliminated in the future and good practices that could be used and adapted by other organizations. The RQAM communicates results of audit, assessments, and reviews with program counterparts to identify areas of excellence, and areas needing corrective actions.

Similarly, when the program or a partner to the Region communicates that QA vulnerability exists within its program or the program it oversees, the RQAM or designee may elect to perform a review. Upon completion of the review, offices or responsible organizations are expected to address any audit findings in writing, documenting the corrective measures to be implemented. Follow-up is performed by the RQAM or designee with the organization to ensure that the resolution reached has been implemented.

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9.6 EFFECTIVE QSRS AND TSRS CONDUCTED BY RQAM

QSRs and direct communication with organizations responsible for performing environmental data collection activities for Region 10 is a necessary tool for the RQAM in detecting and preventing data quality problems. These quality problems may be related to the services provided by the organization, or more systemic problems which affect an organizations ability to produce data of known quality.

QSRs and direct communication with organizations responsible for performing environmental data collection activities for Region 10 is a necessary tool for the RQAM in detecting and preventing data quality problems. These quality problems may be related to the services provided by the organization, or more systemic problems which affect an organizations ability to produce data of known quality.

QSRs and TSRs will be periodically conducted by the RQAM to check the performance of the program, organization and/or offices performing environmental data collection activities by and for Region 10. Field and laboratory audits will be utilized as a preventive measure to ensure that data collection activities are supported by EPA approved QA documentation and data generated are of known and intended quality. It is expected that when deficiencies are identified, corrective action is initiated, documented and effectively implemented by the responsible project officer or manager.

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9.7 QSRS CONDUCTED BY QUALITY STAFF (OEI)

The RQAM relies on the QSRs conducted by OEI every three years on the Region's QS to contribute towards its continual quality improvement. The OEI review is based on the QS described in this QMP. The QSR assesses the effectiveness of the Quality System implemented in the Region and verifies conformance of the implemented system with what is documented in the QMP. OEI identifies areas of QA vulnerability in the Region and ensures that these concerns are adequately addressed by the RQAM and the QAS. The RQAM also works with the RA/DRA and different offices in responding to the comments and developing Corrective Action Plans, if needed.

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Appendix A - Region 10 Organizational Charts

Region 10's Organizational Chart Office of Water and Watersheds Office of Regional Counsel Office of Environmental Cleanup Office of Management Programs Office of Environmental Assessment Office of Ecosystems, Tribal and Public Affairs Washington Operations Office Oregon Operations Office Idaho Operations Office Alaska Operations Office Office of Air, Waste and Toxics Regional Administrator's Office
Figure 1 - Region 10's Organizational Chart (staff and phone listing)



OEA Organizational Chart
Figure 2 - OEA Organizational Chart



Appendix B - Schematic Diagrams - QA Work Processes

RQAM Workflow and Tracking Processes
Figure 3 - RQAM Workflow and Tracking Processes



QA Document Review Process
Figure 4 - QA Document Review Process



Appendix C - List of Acronyms


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