Risk Assessment Program Quality Assurance Plan

1 ES/ER/TM-117/R1 Risk Assessment ProgramQuality Assurance PlanThis document has been approvedby the East Tennessee Technology ParkTechnical Information Officefor release to the public. Date: 11/20/97ES/ER/TM-117/R1 Risk Assessment ProgramQuality Assurance PlanDate Issued November 1997 Prepared byEnvironmental Management and Enrichment Facilities Risk Assessment Program Prepared for Department of EnergyOffice of Environmental Managementunder budget and reporting code EW 20 LOCKHEED MARTIN ENERGY SYSTEMS, theEnvironmental Management Activities at theEast Tennessee Technology ParkOak Ridge Y-12 PlantOak Ridge National LaboratoryPaducah Gaseous Diffusion PlantPortsmouth Gaseous Diffusion Plantunder contract DE-AC05-84OR21400for DEPARTMENT OF ENERGYAPPROVALSRisk Assessment ProgramQuality Assurance PlanES/ER/TM-117/R1 November 1997[name]Sponsor, Department of EnergyDate[name] Department of Energy Environmental ManagementQuality Assurance Program ManagerDate[name]Environmental Management and Enrichment FacilitiesQuality Assurance SpecialistDate[name]

2 Environmental Management and Enrichment FacilitiesRisk Assessment ManagerDate[name]Environmental Management and Enrichment FacilitiesRisk Assessment Program Quality Assurance SpecialistDateiiiPREFACEThis Quality Assurance plan (QAP) for the Environmental Management and EnrichmentFacilities (EMEF) Risk Assessment Program (RAP) specifies Quality Assurance requirements andapplicable standards and procedures. The QAP was produced by the EMEF RAP under WorkBreakdown Structure entitled Risk Assessment Review, Planning, andCoordination and within the Activity Data Sheet 8304. This document provides a plan that identifiesthe responsibilities of RAP personnel and the chain of command for executing Quality primary objective of this document is to establish a QAP that will be in compliance Department of Energy Order , Quality Assurance (DOE 1991) and based onrequirements specified in the ER Quality Program plan (MMES 1994a).

3 AND SOURCE AND APPLICATION OF Quality Assurance Quality ORGANIZATION AND Program Energy Systems EMEF Risk Assessment EMEF Quality Assurance Risk Assessment Program Quality Assurance Energy Systems Risk Assessment Energy Systems Risk Assessment Team Risk Assessment Council Technical Other Program TRAINING AND TRAINING NEEDS TRAINING Program Quality CONTROL OF NONCONFORMING ITEMS OR CORRECTIVE DOCUMENTS AND Quality Assurance DOCUMENT Document Document Controlled WORK INSTRUCTIONS, PROCEDURES, AND DESIGN AUTOMATED DATA-PROCESSING Software Verification and Configuration Control of Automated Data-Processing CONTROL OF PURCHASED ITEMS AND MANAGEMENT INDEPENDENT INDEPENDENT CORRECTIVE INTERNAL SURVEILLANCES .. A. RISK Assessment B. RISK Assessment READINESS REVIEW C. RISK MAPPING VERIFICATION D. RISK Assessment INFORMATION SYSTEM AND ABBREVIATIONSDMCD ocument Management CenterDMIPData Management Implementation Department of EnergyDOE- Department of Energy, Field Office, Oak Ridge Operations Environmental Management DivisionDQOdata Quality objectiveEMEFE nvironmental Management and Enrichment Environmental Protection AgencyEnergy SystemsLockheed Martin Energy Systems, ReportOREISOak Ridge Environmental Information SystemQAquality assuranceQAPQ uality Assurance PlanQASQ uality Assurance SpecialistQCquality controlPGDPP aducah Gaseous Diffusion PlantPORTSP ortsmouth Gaseous Diffusion PlantPRGpreliminary remediation goalRACRisk Assessment CouncilRAISRisk Assessment Information SystemRAMRisk Assessment ManagerRAPRisk Assessment ProgramRATLRisk Assessment Technical LeadSAS Statistical Analysis System (software)ixEXECUTIVE SUMMARYThe Environmental Management and Enrichment Facilities (EMEF) Risk Assessment Program (RAP)

4 Performs or manages all risk Assessment activities conducted for the Department ofEnergy, Field Office, Oak Ridge Operations Environmental Management Division . To accomplishthis role, the EMEF RAP is divided into two functional areas: Central EMEF Oversight andIntegration Activities and Risk Assessment project Support. The Program s main objectives are tooversee and review all risk activities; to produce high- Quality , consistent, and scientifically soundhuman health and ecological risk assessments in accordance with the requirements of theComprehensive Environmental Response, Compensation, and Liability Act; to develop and apply newmethodologies in risk Assessment ; and to implement risk prioritization purpose of this document is to establish a Quality Assurance plan (QAP) for the EMEF RAPso that the Program s objectives can be met effectively in a consistent and logical manner. This QAPhas been developed in compliance with DOE Order , Quality Assurance (DOE 1991),American Society of Mechanical Engineers document Quality Assurance Program Requirements forNuclear Facilities (ASME 1989a), and the software Quality Assurance (QA) requirements fromQuality Assurance Requirements for Nuclear Facility Applications (ASME 1989b).

5 This plan is alsobased on requirements specified in the ER Quality Program plan (MMES 1994a) and in LockheedMartin Energy Systems, Inc., Quality procedures. Specifically, this plan identifies the chain of command for executing Quality requirements, theresponsibilities of EMEF RAP staff, and applicable command media to meet the QA requirements. Inaddition, this QAP includes consideration of the technical aspects of the risk Assessment process in thecontext of QA. This QAP applies to any risk Assessment activity performed by or for the EMEF QAP will be supplemented by procedures that outline steps involved in various risk-relatedtasks. Revisions or additions to the QAP will be made as necessary to conform to the changing needsof the Program . All revisions will be dated and referenced on an approval page at the front ofthe GENERALThe Environmental Management and Enrichment Facilities (EMEF) Risk Assessment Program (RAP) was officially chartered on April 4, 1991, to centralize all risk Assessment efforts under the of Energy, Field Office, Oak Ridge Operations Environmental Management Division(DOE-ORO/EMD) and to ensure the development of consistent and scientifically defensible riskassessments.

6 Interim policy guidance was provided with the charter letter that defined the role of riskassessment and established the Risk Assessment Manager (RAM) and Risk Assessment Council(RAC) positions to provide technical expertise and support in the area of risk Assessment to all parties(including prime contractors and their subcontractors) involved in DOE-ORO/EMD risk assessmentactivities. RAP oversees all EMEF-related risk Assessment activities, leads and manages RAC;provides risk Assessment support for the five Lockheed Martin Energy Systems, Inc. (EnergySystems), EMEF sites at Oak Ridge, Tennessee; Paducah, Kentucky; and Piketon, Ohio; and conductshuman health and ecological risk assessments for the EMEF Program . Throughout the remainder ofthis document, the EMEF RAP will be referred to as primary goals of RAP are to oversee and review all EMEF risk activities; develop,implement, and ensure compliance with risk methodologies; produce high- Quality , consistent, andscientifically defensible human health and ecological risk assessments; and implement riskprioritization evaluations.

7 According to Energy Systems EMEF Program requirements, all riskassessment activities will be consistently conducted with Environmental Protection Agency (EPA)and state guidance , based on best scientific judgement, and carried out in a cost-effective manner. Asa result of adhering to these guidelines, risk Assessment activities will meet all of the pertinentrequirements of the Comprehensive Environmental Response, Compensation, and Liability Act andthe Resource Conservation and Recovery Act. All RAP personnel, Program staff, contractors, andsubcontractors involved in risk Assessment under the auspices of the Energy Systems RAP must followthe procedures set forth in this document; all EMEF procedures, standards, and instructions; andapplicable Energy Systems command media. All data used within RAP must be subjected to adocumented review prior to PURPOSEThis document sets forth requirements for establishing and executing Quality Assurance (QA)measures for RAP to facilitate the development of high- Quality , consistent, and scientifically defensiblerisk assessments.

8 The purposes of this document are to ensure that: RAP management provides planning, organization, direction, control, and support to achieveDOE-ORO/EMD s objectives; RAP achieves Quality in DOE-ORO/EMD risk assessments; and overall performance is frequently reviewed and evaluated .2 This document describes the RAP organizational structure; specifies the QA-related roles andresponsibilities of individuals within RAP to ensure that Program objectives are achieved as planned;and describes or references the controls, Quality procedures, and guidelines that must be implementedduring all risk Assessment SCOPEThis Quality Assurance plan (QAP) applies to all personnel performing risk Assessment activitiesfor RAP. Specifically, this QAP applies to RAP personnel, EMEF Program staff, and all primecontractors and subcontractors involved in risk activities at the five sites operated by Energy Systemsand at the off-site locations under the auspices of RAP.

9 Control of work activities affecting Quality willbe maintained as necessary throughout the life of the Program to ensure that Quality objectives are document may be modified as necessary to meet the specific needs of other primecontractors or subcontractors. If modifications are made, RAM approval must be received, and thechanges and justifications for the changes must be clearly documented, signed, dated, and attachedto this SOURCE AND APPLICATION OF Quality Assurance REQUIREMENTSThe QAP elements identified in this document meet the requirements of DOE Order , Quality Assurance (DOE 1991); the American Society of Mechanical Engineers Quality AssuranceProgram Requirements for Nuclear Facilities (ASME 1989a); and the software QA requirementsfrom Quality Assurance Requirements for Nuclear Facility Applications (ASME 1989b). The QAPhas also been written in compliance with ER Quality Program plan , ES/ER/TM-4/R4(MMES 1994a); Energy Systems QA procedures; and the Health Sciences Research Division,Management plan for CY 1996 (LMES 1996a).

10 Table 1 presents the parallel relationship of the RAP QAP with the ER Quality Program Planand lists the appropriate command media (Energy Systems, EMEF, or other) to implement each RAPQAP chapter. Figure illustrates the interrelationships of EMEF QA requirements. Quality ASSURANCEThe RAP s QA Program will be planned, implemented, and maintained in accordance with thisQAP. QA is the responsibility of all individuals within RAP. The RAP QA Program will implementall applicable Energy Systems and EMEF QA policies, standards, and procedures. In addition, the QAProgram will work to ensure the implementation of the most current policies and procedures asspecified in the various risk Assessment guidance documents produced by EPA, the state, and on the objectives for a particular project , the level of QA may be adjusted other words, some QA requirements specified in this plan may be relaxed or waived; however, alldeviations from the QA process as established in this plan must receive RAM prior approval, and theremust be documentation of the changes and their RAP QAP will be approved by the RAP DOE Sponsor, EMEF Quality Assurance Specialist(QAS), the RAP RAM, and the RAP 1.