Quality Requirements for Extramural Agreements: U.S. EPA Region 5 Perspectives

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Quality Requirements for Extramural
AgreementsU.S. EPA Region 5 Perspectives

• Kevin Bolger
• Amberina Khan
• Office of the Regional Administrator
• U.S. EPA Region 5
• San Antonio
• May 14, 2009

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Quality Requirements for Extramural Agreements
Presentation Goals

• Overview of the basis of EPAs quality
  requirements for environmental data operations
• Types of extramural agreements (EAs)
• Assessing EAs for environmental data operations
  (EDOs)
• Incorporating quality requirements during the EA
  lifecycle (Interagency Agreement example)
• Recommendations for success with managing EAs
  (Interagency Agreement example)

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Quality System (aka Quality Program)

• Structured and documented management system
  describing controls, processes and documentation
  used to plan, implement and assess the
  application of quality within an organization
• Provides the ability for organizations to utilize
  data and information of known and acceptable
  quality for decision-making

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U.S. EPA Quality Systems for Environmental
Programs

• CIO 2105.0 Policy and Program Requirements for
  the Mandatory Agency-Wide Quality System
  (previously EPA Order 5360.1 A2 May 2000) EPA
  Policy which applies directly to U.S. EPA and its
  environmental programs
• ANSI/ASQ E4-2004 Quality Systems for
  Environmental Data and Technology Programs
  Requirements with Guidance for Use February 2004
  Consensus standard which applies to both U.S.
  EPA and extramural organization environmental
  programs

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Implementing U.S. EPAs Quality System

• CIO 2105 and ASNI/ASQ E4-2004 use a multi-tiered
  quality system to describe and document
  organization-level and project-level activities
  for environmental programs
• Organization-level activities documented via a
  quality management plan (QMP)
• Project-level activities documented via a quality
  assurance project plan (QAPP)

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U.S. EPA Quality Systems for Environmental
Programs Keystone Definitions

• Environmental Data
• Environmental Technology
• Environmental Data Operations

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Environmental Data

• Measurements or information describing
• environmental processes, location, or conditions
• ecological or health effects and consequences or
  
• the performance of environmental technology

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Environmental Data

• Environmental data includes the generation,
• assessment and/or use of
• Primary data includes new data from various
  sources including field, lab, computer models,
  and environmental technology, among others
• Secondary data includes existing data from
  databases, data resulting from previous projects,
  and the scientific literature, among others

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Environmental Technology

• All-inclusive term used to describe
• pollution monitoring, measurement and control
  devices and systems
• waste treatment processes and storage facilities
  
• site remediation technologies to remove or
  prevent pollutants from entering the environment

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Environmental Data Operations (EDOs)

• Work performed to obtain, use, or report
  information pertaining to environmental processes
  and conditions
• Inclusive of environmental data and environmental
  technology

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Applicability of U.S. EPAs Quality System

• Quality systems must be documented and
• implemented when environmental data
• operations are conducted
• directly by U.S. EPA or
• on behalf of U.S. EPA through various means
  including extramural agreements

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Extramural Agreements

• Documented legal agreements between EPA and an
  organization external to EPA for items and/or
  services by the organization
• Acquisition agreements include all types of
  acquisitions from simple purchases to contracts
  (40 CFR 46)
• Assistance agreements include grants, cooperative
  agreements and interagency agreements (40 CFR
  Parts 30, 31, 35 and 40 among others)

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U.S. EPA Quality Requirements

• Apply a Graded Approach to quality requirements
  commensurate with the proposed environmental data
  operations
• EPA specifies quality requirements to be
  submitted and/or conducted during pre-award and
  post-award of EA lifecycle
• Default quality requirements include
  organization-level documentation (i.e. QMP)
  during pre-award and project-level documentation
  (i.e. QAPPs, Standard Operating Procedures
  (SOPs)) during post-award
• Other types of quality requirements may include
  non-traditional documents such as joint QMP/QAPP

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Assessing EAs General Issues

• Identifying EDOs early and often in the scope of
  solicitations, proposals, work assignments and
  throughout the EA lifecycle (Can you find the
  EDOs?)
• Recognition of models, secondary data, etc
  (Were not collecting any samples!)
• Masking of EDOs behind a non-EDO oriented
  proposal, work assignment, etc (This is only an
  environmental education project)
• Dealing with existing quality documentation (We
  already did a QAPP in 2002 !)

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EA Example
Interagency Agreements (IAs)

• IAs are different and can be more complex
  compared with other types of EAs
• IAs use an assistance agreement vehicle supported
  by other extramural agreements such as contracts
  or cooperative agreements
• EPA role as either a receiving vs servicing
  agency
• EPA staff with assistance and acquisition
  experience increase the odds for the IAs
  potential success

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Types of IAs

• EAs which provide goods and/or services
• as follows
• Federal between Federal agencies
• Intergovernmental between Federal agency and
  state, local, tribal government
• International between Federal agency and
  foreign government, entity,etc

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IA Funds Flow

• Funds Out EPA provides funds and receives
  products/services
• Funds In EPA receives funds and provides
  products/services
• No Funds Exchanged No transfer of funds each
  organization bears own expenses
• Allocation transfers funds transferred between
  agencies by special authorization in conjunction
  with OMB

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IA-Specific Quality Issues

• Identify quality issues pertinent to each IA and
  the structure of the IA-supporting contracts,
  cooperative agreements, etc
• U.S. EPAs role/perspective as either the
  servicing or receiving organization
• Negotiation of quality requirements between U.S.
  EPA and the extramural organization
• Negotiation of quality assurance roles and
  responsibilities for each organization

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IA Lifecycle Development

• IA Project Officer (IA PO) initiates discussion
  of potential IA with the designated U.S. EPA QA
  representative
• IA PO and designated QA representative jointly
  determine whether the scope of the IA will or may
  include environmental data operations
• Include U.S. EPA and extramural organization QA
  managers in joint meetings for IAs with
  environmental data operations

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IA Lifecycle Development

• For IAs which include environmental data
• operations, identify the following
• Applicable extramural agreements, international
  consensus standards (ISO 9000), Federal and/or
  state laws (i.e. Information Quality Act),
  multi-agency policies (Uniform Federal Policy
  between EPA DOD) or other overarching
  quality-related documents which must be
  considered in conjunction with the new IA
• Existing quality system documents (i.e. QMPs) for
  the requesting and servicing organizations and
  other supporting organizations (i.e. contractors)

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IA Lifecycle Development

• Identify new or existing quality documentation
  and/or other quality requirements to be
  submitted, reviewed and approved/completed during
  pre-award and post-award of the IA
• Identify respective QA roles and responsibilities
  of U.S. EPA and other organization throughout the
  IA cycle
• Document the quality requirements and QA roles
  and responsibilities as IA terms and conditions

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IA Lifecycle Pre-Award

• IA PO and U.S. EPA QA Manager jointly
• Review, reconcile issues and approve all
  submitted pre-award quality requirements and
  coordinate closely with their counterparts at the
  other agency
• and/or
• Provide same with other agency when EPA provides
  environmental data operations

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IA Lifecycle Post-Award

• IA PO and U.S. EPA QA Manager jointly
• Review, reconcile issues and approve all
  submitted post-award quality requirements and
  coordinate closely with their counterparts at the
  other agency
• and/or
• Provide same with other agency when EPA provides
  environmental data operations

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IA Lifecycle Implementation, Oversight and
Closeout

• IA PO and U.S. EPA QA Manager jointly
• Assess/report implementation of quality
  requirements (i.e. project-level QA activities,
  periodic audits) in conjunction with their
  counterparts in the other agency
• Confirm that all IA QA requirements and
  environmental data operations were completed and
  met quality objectives

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Recommendations for Success with IAs

• IA PO and QA Manager jointly assess the scope of
  the proposed IA for environmental data operations
• Document/summarize the relationship under the IA
  between EPA and the other agency
• Define EPAs and other agencys roles and
  responsibilities (including QA) for the EDOs
• Identify existing EAs which will support the IA

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Recommendations for Success with IAs

• Assess the applicability of existing quality
  documentation, audits and consensus standards to
  the IA
• Negotiate IA quality requirements between EPA and
  the other agency
• Document quality requirements as terms and
  conditions for all stages (i.e. pre- and
  post-award) of the IA lifecycle
• IA PO and QA Manager maintain active involvement
  through review, approval and assessment of all
  quality requirements

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More Questions?

• Kevin Bolger
• Regional QA Manager
• U.S.EPA Region 5
• 312-886-6762
• bolger.kevin_at_epa.gov