Quality Requirements for Quality Requirements for Extramural Agreements:Extramural Agreements:

U.S. EPA Region 5 PerspectivesU.S. EPA Region 5 Perspectives

Kevin BolgerKevin BolgerAmberina KhanAmberina Khan

Office of the Regional AdministratorOffice of the Regional AdministratorU.S. EPA Region 5U.S. EPA Region 5

San AntonioSan AntonioMay 14, 2009May 14, 2009

Quality Requirements for Extramural Quality Requirements for Extramural Agreements: Presentation GoalsAgreements: Presentation Goals

Overview of the basis of EPA’s quality Overview of the basis of EPA’s quality requirements for environmental data operationsrequirements for environmental data operations

Types of extramural agreements (EAs)Types of extramural agreements (EAs) Assessing EAs for environmental data Assessing EAs for environmental data

operations (EDOs)operations (EDOs) Incorporating quality requirements during the EA Incorporating quality requirements during the EA

lifecycle (Interagency Agreement example)lifecycle (Interagency Agreement example) Recommendations for success with managing Recommendations for success with managing

EAs (Interagency Agreement example)EAs (Interagency Agreement example)

Quality System (aka Quality Quality System (aka Quality Program)Program)

Structured and documented management Structured and documented management system describing controls, processes and system describing controls, processes and documentation used to plan, implement documentation used to plan, implement and assess the application of quality within and assess the application of quality within an organizationan organization

Provides the ability for organizations to Provides the ability for organizations to utilize data and information of known and utilize data and information of known and acceptable quality for decision-makingacceptable quality for decision-making

U.S. EPA Quality Systems for U.S. EPA Quality Systems for Environmental ProgramsEnvironmental Programs

CIO 2105.0CIO 2105.0 Policy and Program Requirements Policy and Program Requirements for the Mandatory Agency-Wide Quality System for the Mandatory Agency-Wide Quality System (previously EPA Order 5360.1 A2 May 2000) – (previously EPA Order 5360.1 A2 May 2000) – EPA Policy which applies directly to U.S. EPA EPA Policy which applies directly to U.S. EPA and its environmental programsand its environmental programs

ANSI/ASQ E4-2004ANSI/ASQ E4-2004 Quality Systems for Quality Systems for Environmental Data and Technology Programs – Environmental Data and Technology Programs – Requirements with Guidance for Use Requirements with Guidance for Use February February 2004 – 2004 – Consensus standard which applies to Consensus standard which applies to both U.S. EPA and extramural organization both U.S. EPA and extramural organization environmental programsenvironmental programs

Implementing U.S. EPA’s Implementing U.S. EPA’s Quality SystemQuality System

CIO 2105 and ASNI/ASQ E4-2004 use a CIO 2105 and ASNI/ASQ E4-2004 use a multi-tiered quality system to describe and multi-tiered quality system to describe and document organization-level and project-document organization-level and project-level activities for environmental programslevel activities for environmental programs

Organization-level activities documented Organization-level activities documented via a quality management plan (QMP)via a quality management plan (QMP)

Project-level activities documented via a Project-level activities documented via a quality assurance project plan (QAPP)quality assurance project plan (QAPP)

U.S. EPA Quality Systems for Environmental U.S. EPA Quality Systems for Environmental

Programs: Keystone DefinitionsPrograms: Keystone Definitions

Environmental DataEnvironmental Data Environmental TechnologyEnvironmental Technology Environmental Data OperationsEnvironmental Data Operations

Environmental DataEnvironmental Data

Measurements or information describing:Measurements or information describing: environmental processes, location, or environmental processes, location, or

conditions;conditions; ecological or health effects and ecological or health effects and

consequences; or consequences; or the performance of environmental the performance of environmental

technologytechnology

Environmental DataEnvironmental Data

Environmental data includes the generation,Environmental data includes the generation,assessment and/or use of:assessment and/or use of: Primary dataPrimary data includes new data from includes new data from

various sources including field, lab, various sources including field, lab, computer models, and environmental computer models, and environmental technology, among otherstechnology, among others

Secondary dataSecondary data includes existing data includes existing data from databases, data resulting from from databases, data resulting from previous projects, and the scientific previous projects, and the scientific literature, among othersliterature, among others

Environmental TechnologyEnvironmental Technology

All-inclusive term used to describe:All-inclusive term used to describe: pollution monitoring, measurement and pollution monitoring, measurement and

control devices and systems;control devices and systems; waste treatment processes and storage waste treatment processes and storage

facilities; facilities; site remediation technologies to remove or site remediation technologies to remove or

prevent pollutants from entering the prevent pollutants from entering the environmentenvironment

Environmental Data Operations (EDOs)Environmental Data Operations (EDOs)

Work performed to obtain, use, or report Work performed to obtain, use, or report information pertaining to environmental information pertaining to environmental processes and conditionsprocesses and conditions

Inclusive of environmental data and Inclusive of environmental data and environmental technologyenvironmental technology

Applicability of U.S. EPA’s Quality Applicability of U.S. EPA’s Quality SystemSystem

Quality systems must be documented and Quality systems must be documented and

implemented when environmental data implemented when environmental data

operations are conducted: operations are conducted:

directly by U.S. EPA ordirectly by U.S. EPA or

on behalf of U.S. EPA through various on behalf of U.S. EPA through various means including extramural agreementsmeans including extramural agreements

Extramural AgreementsExtramural Agreements

Documented legal agreements between Documented legal agreements between EPA and an organization external to EPA EPA and an organization external to EPA for items and/or services by the for items and/or services by the organization organization

Acquisition agreementsAcquisition agreements include all types of include all types of acquisitions from simple purchases to acquisitions from simple purchases to contracts (40 CFR 46)contracts (40 CFR 46)

Assistance agreements Assistance agreements include grants, include grants, cooperative agreements and interagency cooperative agreements and interagency agreements (40 CFR Parts 30, 31, 35 and agreements (40 CFR Parts 30, 31, 35 and 40 among others)40 among others)

U.S. EPA Quality RequirementsU.S. EPA Quality Requirements Apply a Apply a Graded Approach Graded Approach to quality requirements to quality requirements

commensurate with the proposed environmental data commensurate with the proposed environmental data operations operations

EPA specifies quality requirements to be submitted EPA specifies quality requirements to be submitted and/or conducted during pre-award and post-award of and/or conducted during pre-award and post-award of EA lifecycleEA lifecycle

Default quality requirements include organization-level Default quality requirements include organization-level documentation (i.e. QMP) during pre-award and documentation (i.e. QMP) during pre-award and project-level documentation (i.e. QAPPs, Standard project-level documentation (i.e. QAPPs, Standard Operating Procedures (SOPs)) during post-awardOperating Procedures (SOPs)) during post-award

Other types of quality requirements may include non-Other types of quality requirements may include non-traditional documents such as joint QMP/QAPPtraditional documents such as joint QMP/QAPP

Assessing EAs: General IssuesAssessing EAs: General Issues Identifying EDOs early and often in the scope of Identifying EDOs early and often in the scope of

solicitations, proposals, work assignments and solicitations, proposals, work assignments and throughout the EA lifecycle (Can you find the throughout the EA lifecycle (Can you find the EDOs?)EDOs?)

Recognition of models, secondary data, etc Recognition of models, secondary data, etc (“We’re not collecting any samples!”)(“We’re not collecting any samples!”)

““Masking” of EDOs behind a non-EDO oriented Masking” of EDOs behind a non-EDO oriented proposal, work assignment, etc (“This is only an proposal, work assignment, etc (“This is only an environmental education project”)environmental education project”)

Dealing with existing quality documentation (“We Dealing with existing quality documentation (“We already did a QAPP in 2002 !”) already did a QAPP in 2002 !”)

EA Example: EA Example: Interagency Agreements (IAs)Interagency Agreements (IAs)

IAs IAs areare different and can be more complex different and can be more complex compared with other types of EAscompared with other types of EAs

IAs use an assistance agreement vehicle IAs use an assistance agreement vehicle supported by other extramural agreements such supported by other extramural agreements such as contracts or cooperative agreementsas contracts or cooperative agreements

EPA role as either a receiving vs servicing EPA role as either a receiving vs servicing agencyagency

EPA staff with assistance EPA staff with assistance andand acquisition acquisition experience increase the odds for the IA’s experience increase the odds for the IA’s potential success potential success

Types of IAsTypes of IAs

EAs which provide goods and/or services EAs which provide goods and/or services

as follows:as follows: Federal – between Federal agenciesFederal – between Federal agencies Intergovernmental – between Federal Intergovernmental – between Federal

agency and state, local, tribal governmentagency and state, local, tribal government International – between Federal agency International – between Federal agency

and foreign government, entity,etcand foreign government, entity,etc

IA Funds FlowIA Funds Flow

Funds Out – EPA provides funds and Funds Out – EPA provides funds and receives products/servicesreceives products/services

Funds In – EPA receives funds and Funds In – EPA receives funds and provides products/servicesprovides products/services

No Funds Exchanged – No transfer of No Funds Exchanged – No transfer of funds; each organization bears own funds; each organization bears own expensesexpenses

Allocation transfers – funds transferred Allocation transfers – funds transferred between agencies by special authorization between agencies by special authorization in conjunction with OMB in conjunction with OMB

IA-Specific Quality IssuesIA-Specific Quality Issues

Identify quality issues pertinent to each IA and Identify quality issues pertinent to each IA and the structure of the IA-supporting contracts, the structure of the IA-supporting contracts, cooperative agreements, etccooperative agreements, etc

U.S. EPA’s role/perspective as either the U.S. EPA’s role/perspective as either the servicing or receiving organizationservicing or receiving organization

Negotiation of quality requirements between Negotiation of quality requirements between U.S. EPA and the extramural organizationU.S. EPA and the extramural organization

Negotiation of quality assurance roles and Negotiation of quality assurance roles and responsibilities for each organizationresponsibilities for each organization

IA Lifecycle: DevelopmentIA Lifecycle: Development

IA Project Officer (IA PO) initiates discussion of IA Project Officer (IA PO) initiates discussion of potential IA with the designated U.S. EPA QA potential IA with the designated U.S. EPA QA representativerepresentative

IA PO and designated QA representative jointly IA PO and designated QA representative jointly determine whether the scope of the IA will or determine whether the scope of the IA will or may include environmental data operationsmay include environmental data operations

Include U.S. EPA and extramural organization Include U.S. EPA and extramural organization QA managers in joint meetings for IAs with QA managers in joint meetings for IAs with environmental data operationsenvironmental data operations

IA Lifecycle: DevelopmentIA Lifecycle: Development

For IAs which include environmental dataFor IAs which include environmental dataoperations, identify the following:operations, identify the following:

Applicable extramural agreements, international Applicable extramural agreements, international consensus standards (ISO 9000), Federal consensus standards (ISO 9000), Federal and/or state laws (i.e. Information Quality Act), and/or state laws (i.e. Information Quality Act), multi-agency policies (Uniform Federal Policy multi-agency policies (Uniform Federal Policy between EPA & DOD) or other overarching between EPA & DOD) or other overarching quality-related documents which must be quality-related documents which must be considered in conjunction with the new IAconsidered in conjunction with the new IA

Existing quality system documents (i.e. QMPs) Existing quality system documents (i.e. QMPs) for the requesting and servicing organizations for the requesting and servicing organizations and other supporting organizations (i.e. and other supporting organizations (i.e. contractors)contractors)

IA Lifecycle: DevelopmentIA Lifecycle: Development

Identify new or existing quality documentation Identify new or existing quality documentation and/or other quality requirements to be and/or other quality requirements to be submitted, reviewed and approved/completed submitted, reviewed and approved/completed during pre-award and post-award of the IAduring pre-award and post-award of the IA

Identify respective QA roles and responsibilities Identify respective QA roles and responsibilities of U.S. EPA and other organization throughout of U.S. EPA and other organization throughout the IA cyclethe IA cycle

Document the quality requirements and QA roles Document the quality requirements and QA roles and responsibilities as IA terms and conditionsand responsibilities as IA terms and conditions

IA Lifecycle: Pre-AwardIA Lifecycle: Pre-Award

IA PO and U.S. EPA QA Manager jointly:IA PO and U.S. EPA QA Manager jointly: Review, reconcile issues and approve all Review, reconcile issues and approve all

submitted pre-award quality requirements submitted pre-award quality requirements and coordinate closely with their and coordinate closely with their counterparts at the other agencycounterparts at the other agency

and/orand/or Provide same with other agency when Provide same with other agency when

EPA provides environmental data EPA provides environmental data operations operations

IA Lifecycle: Post-AwardIA Lifecycle: Post-Award

IA PO and U.S. EPA QA Manager jointly:IA PO and U.S. EPA QA Manager jointly: Review, reconcile issues and approve all Review, reconcile issues and approve all

submitted post-award quality requirements submitted post-award quality requirements and coordinate closely with their and coordinate closely with their counterparts at the other agencycounterparts at the other agency

and/orand/or Provide same with other agency when Provide same with other agency when

EPA provides environmental data EPA provides environmental data operations operations

IA Lifecycle: Implementation, IA Lifecycle: Implementation, Oversight and CloseoutOversight and Closeout

IA PO and U.S. EPA QA Manager jointly:IA PO and U.S. EPA QA Manager jointly: Assess/report implementation of quality Assess/report implementation of quality

requirements (i.e. project-level QA requirements (i.e. project-level QA activities, periodic audits) in conjunction activities, periodic audits) in conjunction with their counterparts in the other agencywith their counterparts in the other agency

Confirm that all IA QA requirements and Confirm that all IA QA requirements and environmental data operations were environmental data operations were completed and met quality objectivescompleted and met quality objectives

Recommendations for Success with IAsRecommendations for Success with IAs

1.1. IA PO and QA Manager jointly assess the IA PO and QA Manager jointly assess the scope of the proposed IA for environmental scope of the proposed IA for environmental data operationsdata operations

2.2. Document/summarize the relationship under Document/summarize the relationship under the IA between EPA and the other agency the IA between EPA and the other agency

3.3. Define EPA’s and other agency’s roles and Define EPA’s and other agency’s roles and responsibilities (including QA) for the EDOs responsibilities (including QA) for the EDOs

4.4. Identify existing EAs which will support the IAIdentify existing EAs which will support the IA

Recommendations for Success with IAsRecommendations for Success with IAs

5.5. Assess the applicability of existing quality Assess the applicability of existing quality documentation, audits and consensus documentation, audits and consensus standards to the IAstandards to the IA

6.6. Negotiate IA quality requirements between Negotiate IA quality requirements between EPA and the other agency EPA and the other agency

7.7. Document quality requirements as terms Document quality requirements as terms and conditions for all stages (i.e. pre- and and conditions for all stages (i.e. pre- and post-award) of the IA lifecyclepost-award) of the IA lifecycle

8.8. IA PO and QA Manager maintain active IA PO and QA Manager maintain active involvement through review, approval and involvement through review, approval and assessment of all quality requirementsassessment of all quality requirements

More Questions?More Questions?

Kevin BolgerKevin Bolger Regional QA ManagerRegional QA Manager U.S.EPA Region 5U.S.EPA Region 5 312-886-6762 312-886-6762 bolger.kevin@epa.gov