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]

2 Sponsor, Department of EnergyDate[name] Department of Energy Environmental ManagementQuality Assurance Program ManagerDate[name]Environmental management and Enrichment FacilitiesQuality Assurance SpecialistDate[name]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.

3 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). 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.

4 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.

5 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) performs or manages all risk Assessment activities conducted for the Department ofEnergy, Field Office, Oak Ridge Operations Environmental management Division.

6 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.

7 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). 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.

8 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.

9 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 .

10 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. 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.