Quality Assurance Source Requirements Traceability Database. Ram Murthy. Anna Naydenova

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1 Quality Assurance Source Requirements Traceability Database Ram Murthy MOL U.S. Department of Energy, Office of Civilian Radioactive Waste Management, Office of Quality Assurance 1551 Hillshire Dr, Las Vegas, NV, 89134, Anna Naydenova Science Applications International Corporation 1551 Hillshire Dr, Las Vegas, NV, 89134, Richard DeKlever Navarro Quality Services I55 I Hillshire Dr, Las Vegas, NV, , richard-deklever@ymp.gov Alesia Boone US. Department of Energy, Wce of Civilian Radioactive Waste Management, Office of Program Management, Information Technology Division 1551 Hillshire Dr, Las Vegas, NV 89134, alesia-boone@ymp.gov Abstract -At the Yucca Mountain Project the Project Requirements Processing System assists in the management of relationships between regulatory and national/industry standards source criteria, and Quality Assurance Requirements and Description document (DOE/R W-0333P) requirements to create compliance matrices representing respective relationships. The matrices are submitted to the U.S. Nuclear Regulatory Commission to assist in the commission 's review, interpretation, and concurrence with the Yucca Mountain Project QA program document. The tool is highly customized to meet the needs of the Office of Civilian Radioactive Waste Management Office of Quality Assurance. I. INTRODUCTION The U.S. Department of Energy (DOE) Office of Civilian Radioactive Waste Management (OCRWM) Office of Quality Assurance (OQA) at the Yucca Mountain Project's (YMP) Office of Repository Development (ORD) uses an Intranet relational database application to track compliance with U.S. Nuclear Regulatory Commission (NRC) criteria. Because the database is developed in-house, OQA has been able to influence data management and display, access controls, and information filtering to achieve customizations not offered in out-of-the-box commercial off the shelf (COTS) products. Based on well-established technologies, the Project Requirements Processing system (PW) offers customizations geared towards the purposes of OQA while remaining compatible with other project software. 11. BACKGROUND The Nuclear Waste Policy Act of 1982 (NWPA), as amended December 2 1, 1995,[ 11 established the OEce of Civilian Radioactive Waste Management (OCRWM) within the Department of Energy (DOE) and directed DOE to implement a program for handling high-level radioactive waste (HLW) and spent nuclear fuel (SNF) compliant with applicable federal and state laws and/or regulations. The NWPA mandates that the planned repository be licensed for design, construction, and operation by the U.S. Nuclear Regulatory Commission (NW. A comprehensive and effective Quality Assurance (QA) Program is essential for the performance of work for all phases of the OCRWM Program. OCRWM responsibilities are to ensure that appropriate QA controls are in place for verification by NRC; and that the systems, structures, and components (SSC) important to safety and

2 waste isolation under postulated conditions will not cause undue (radiological) risk to health and safety of repository workers and the public. As such, the OCRWM QA Program, as delineated in the Quality Assurance Requirements and Description (QARD), DOERW- 0333P, and approved implementing documents, has been established for items and activities governed by NRC regulations in relation to site characterization, design, and construction of the geologic repository at Yucca Mountain. QA programs for most U. S. commercial nuclear facilities are derived from 10 CFR 50[2] Appendix B, Quality Assurance (App. B). NRC have drawn from their vast experience developed during licensing the design, construction, and operation of such facilities over the past five decades to enact and promulgate the YMP QA program through 10 CFR 60[3], Subpart G. The basic App. B program was expanded to incorporate five supplements and appendices to control scientific investigation and data processing during site characterization activities based on 10 CFR 60 program requirements. The supplements added QA controls for managing software; sample control; scientific experiments, data qualification, and modeling; site surveys; and electronic management of information. The appendices added specific requirements and controls for HLW and SNF; and for interim storage and transportation of HLW and SNF. Over the past thirteen years various revisions of the QARD [4] have been developed, reviewed, and approved by DOE management and accepted by the NRC. In 2002, 10 CFR 63[5] was issued and set the initiative for DOE to develop its license application for NRC review and approval that would provide the basis and authorization for design and construction of a repository for HLW and SNF at Yucca Mountain. Supportive to the regulatory QA requirements identified in 10 CFR are NRC requirements, positions, and guidance presented in NUREG-1 804[6], Yucca Mountain Review Plan, section 2.5.1, Quality Assurance Program, which establish the basis for NRC review of the YMP QA program and to ensure satisfying requirements for the license application. Table I, shown below, presents the fifteen (1 5) primary Regulatory, Commitment, and Guidance source documents that establish the basis for the requirements in the QARD. The approved QARD R17 complies with 10 CFR , Quality Assurance Criteria, and will become integral to the YMP repository Safety Analysis Report and will subsequently support the license application. Requirements presented in this QARD revision are applicable to SSC s classified important to safety or waste isolation, barriers important to waste isolation, and consumables classified important to safety or waste isolation and their related activities. These items and consumables are maintained in a controlled project Q - List. Table I. Source Documents which contain Criteria - Establish Basis for QARD R17 Requirements Table I.A. Regulatory Source Documents SOURCE DOCUMENT NO 1 TITLE 10 CFR I Oualitv Assurance Criteria SOURCE DOCUMENT NO ANSVANS ASME NQA Subpart 2.7 ASME NQA-la-1983 ASNT TC-1A-1980 NRC IN NRC NUREG NRC NUREG NRC NUREG NRC NUREG NRC Regulatory Guide 1.28 NRC Regulatory Guide 1.8 TITLE Selection and Training of Personnel for Nuclear Power Plants Quality Assurance Requirements for Computer Software for Nuclear Facility Applications Quality Assurance Program Requirements for Nuclear Power Plants [as amended by ASME NQA-la-1983, Addenda] Recommended Practice for Nondestructive Testing Personnel Qualification and Certification Recognition of American Society of Mechanical Engineers Accreditation Program for N Stamp Holders, including Supplement 2, April 16, 1991 Peer Review for High-Level Nuclear Waste Renositories. Februarv 1988 Y, -- Qualification of Existing Data for High Level Nuclear Waste Repositories, February 1988 Branch Technical Position on the use of Expert Elicitation in the High-Level Radioactive Waste Program, November 1996 Regulatory Perspective on Model Validation in High-Level Nuclear Waste Management Programs, March 1999 Quality Assurance Program Requirements (Design and Construction) Revision 3, August 1985 Qualification and Training of Personnel for Nuclear Power Plants. Revision 3. Mav 2000

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7 4 V. CONCLUSIONS The evolution of the OCRWM QA program necessitated the adoption of automated criteria vs. requirements implementation tracking and CM generation, which led to the design of the PRP database. Through use of the PRP, OQA has enhanced review and approval features for the development and maintenance of the QARD. The tool has assisted in NRC reviews and has proven to be an asset to the project. ACKNOWLEDGMENTS Many thanks are extended to those Navarro Quality Services, Quality Systems and Engineering personnel who supported development of the final compliance matrices. Sincere appreciation to SAIC and Catapult Technology Ltd. management and staff for guidance in the paper creation and approval process. REFERENCES 1. Nuclear Waste Policy Act of 1982, Public Law ,42 USC , 1983, as amended by Title V of Public Law , 1987, Washington, D.C; as amended by Public Law , Title I, Subtitle E, sec. 1052(1), (109 Stat. 719), December 21, Appendix B, Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants, 10 CFR Part 50 - Domestic Licensing of Production and Utilization Facilities. Subpart G, Quality Assurance, Disposal of High- Level Radioactive Wastes in Geologic Repositories, 10 CFR Part 60 - Disposal of High-Level Radioactive Wastes in Geologic Repositories. DONALD G. HORTON, The History of the Quality Assurance Requirements, Proceedings of the ASQC Twenty First Annual National and Environmental Quality Division Conference, Improving the Civilian Radioactive Waste Management Quality Assurance Program for Scientific Investigations - Tailoring Quality Requirements to Fit the Need (1994). Section.142, Quality Assurance Criteria, 10 CFR Part 63 - Disposal of High-Level Radioactive Wastes in a Geologic Repository at Yucca Mountain, Nevada. NUREG-1804, Revision 2, Yucca Mountain Review Plan (2003). Capability Maturity Model@ Integration (CMMISM), Version 1.1, CMMISM for Software Engineering (CMMI-SW, V1. l), Staged Representation (2002). ITS Standard Software Process library.

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