1. Quality Assurance Program National Enrichment Facility Warren Dorman September 19, 2005 2005 National Energy and Environmental Conference

2. Agenda Introduction Organization QA Program Basis Management Measures Application Approval Basis Program Applicability Quality Level QL-1 and 2 Program Elements Configuration Management- Design Phase 2

3. Introduction QA Program Description (QAPD) was reviewed and approved by the NRC in April 2004 Included as Appendix A of Safety Analysis Report Chapter 11, “Management Measures.” License application is principally under 10CFR 70, “Domestic Licensing of Special Nuclear Material.” Regulator will be NRC 3

4. Organization Consortium of Urenco, Westinghouse, Exelon, Entergy, and Duke Power President and CEO- Jim Ferland Vice President Licensing, Safety, and Nuclear Engineering- Rod Krich Vice President Projects-Mike Lynch 4

5. QA Program Basis 10 CFR 70.22 (f)- A description of the quality assurance program to be applied to the design, fabrication, construction, testing and operation of the structures, systems, and components of the plant based on criteria of 10CFR 50 App B. 5

6. Management Measures 10CFR 70.62(d) - Management measures…shall establish management measures to ensure compliance with the performance requirements of 70.61, “Performance Requirements 10CFR 70.65 (b)(4) - Management measures mean the functions performed by the licensee, generally on a continuing basis, that are applied to items relied on for safety, to ensure the items are available and reliable to perform their functions when needed 6

7. Management Measures (con’t) NUREG- 1520, “Standard Review Plan for the Review of a License Application for A fuel Cycle Facility.” Section 11 “Management Measures” Criteria for Management Measures is in addition to QA criteria. Management Measures are implemented through the QAPD 7

8. Application Approval Basis 10CFR 23(b)….when the Commission has determined that the design bases of the principal structures, systems, and components, and the quality assurance program provide reasonable assurance of protection against natural phenomena and the consequences of potential accidents. 8

9. Program Applicability Applies to [IROFS] items relied on for safety means structures, systems, components (SSC),and items that affect IROFS and; Safe by Design components, and; Activities of personnel that are: –relied on to prevent potential accidents at a facility that could exceed the performance requirements in 70.61 –or to mitigate their potential consequences. 9

10. Quality Level Facility components and processes are assigned a QA Level based on their safety significance. –Quality Level 1 Applied to SSC’s and administrative controls determined to be IROFS. Any items which are determined to affect the function of the IROFS. To items required to satisfy regulatory requirements Applies to development of Integrated Safety Analysis Summary Process. 10

11. Quality Level (con’t) –Quality Level 2 SSCs and associated activities that are not IROFS. –Owner designated SSCs and activities. Provide support of normal operations. Do not affect the function of the IROFS, e.g., occupational exposure, radioactive waste management 11

12. Quality Level (con’t) –Quality Level 3 Standard commercial practice. Level 3 covers all activities not designated as QA Level 1 or QA Level 2. Documented Level 3 program not required. 12

13. QL-1 Program Elements 18 Criteria- Same as App B. Implement with NQA-1-1994 w/NQA-1a- 1995 addenda (NQA-1). –NRC required explicit commitment to certain Supplementary Requirements. –Part II, Subpart 2.7- Computer Software for Nuclear Facility Application 13

14. QL-2 Program Elements Owner defined program, use NQA-1 as guidance. Contractors’ Level 2 QA program manual must be approved by LES. Contractors’ Level 2 program documents which are to be approved by LES. ISO-9000 series program is acceptable. 14

15. QL-2 Program Elements (con’t) Process should include a determination of which QA controls are necessary. Use of nuclear industry precedent acceptable. Specific elements to be included, e.g., Organization, Procedures, Design 15

16. Configuration Management Design Phase Scope –IROFS identified by the Integrated Safety Analysis.(ISA) –Design documents are subject to Configuration Management. 16

17. Configuration Management Design Phase (con’t) Program –Design requirements are to be documented in a Design Requirements Document. –Procedures for controlling design. –Changes to approved design are reviewed to ensure consistency with design bases if IROFS. –Audits and assessments are required. 17

18. Configuration Management Design Phase (con’t) Program (con’t) –ISA team review, includes review of ISA impacts. –Verification process 18

19. QUESTIONS? 19