NQA – 1 QUALITY ASSURANCE REQUIREMENTS FOR NUCLEAR FACILITY APPLICATIONS Presented By – Robert G. Burns, PE 32nd National Energy & Environmental Division Conference in San Antonio , Texas SCOPE • NQA – 1 An Historical Perspective • NQA – 1 User Community • Scope, Structure and Content • Basic, Supplements and Non-mandatory Appendices Slide 2 TYPICAL USERS • • • • Utilities / Power Generators ASME Section III Users Department of Energy National Laboratories, Repositories and Fuel Fabrication facilities • Trans Alaska Pipeline • Offshore Nuclear Power Projects • LES Enrichment Project Slide 3 PRECURSOR DOCUMENTS FOR DEVELOPING QA REQUIREMENTS FOR NQA-1 • Mil - Q-9858 Quality System • Mil - I-45208 Inspection System • Mil - C-45662 Calibration System • NASA NPC 200-2 • BUSHIPS BSI 4410.17 • 10CFR50, Appendix B • 10 CFR50 Appendix A, Criterion 1 • The ASQ NPTC Matrix Initiative Slide 4 QUALITY RELATED REGULATIONS, RULES, ORDERS, CODES & STANDARDS CIVILIAN NUCLEAR DEPARTMENT OF ENERGY ENVIRONMENTAL 10 CFR 50, Appendix B ( NRC Programmatic ) 10CFR 830, Subpart A ( Nuclear – Programmatic ) EPA QA/R-2 ( EPA Requirements for Quality Management Plans ) 10CFR50, Part 21 ( Reporting Defects ) 10CFR820, Appendix A ( Price Anderson) 10 CFR50.55 ( Codes & Standards ) DOE O 414.A ( Quality Assurance ) R.G. 1.28 ( NRC Adoption of ANSI/ASME Standards) ASME Section III ( BPVC – Nuclear ) ASME NQA-1 ( Quality Program ) DOE G 414.1-2 ( QA Management System ) DOE G 414.I-1 ( Independent & Management Assessment ) DOE P 450.4 ( Safety Management System ) EPA QA/R- 5 ( EPA Requirements for QA Project Plans ) ANSI/ASQC E4-1994 ( Specifications and Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology Programs ) RW-0333P OCRWM-YMP ( Waste Repository QA Program ) Slide 5 COMM’L/INTERNATIONAL ISO-9001-2000 ( QA Program ) ISO-14001 ( Environmental Management System ) ASME VIII ( Non-nuclear QA/QC ) Note Adoption / use of an ISO program does not require Certification. BRIEF HISTORY OF NQA-1 ANSI ASME-American Society of Mechanical Engineers N45.2 Quality Assurance Requirements for Nuclear Power Plants AIChE -American Institute of Chemical Engineers N46.2 QA Program Requirements for Post Nuclear Fuel Cycle Facilities N45.2.6-Qualification of Inspection, Examination and Testing Personnel for Nuclear Power Plants N45.2.9-Requirements for Collection, Storage and Maintenance of Quality Assurance Records N45.2.10-Quality Assurance Terms and Definitions N45.2.11-Quality Assurance Requirements for the Designof Nuclear Power Plants N45.2.12-Requirements for Auditing of Quality assurance Programs for Nuclear Power Plants N45.2.13-Quality Assurance Requirements for Control of Procurement of Items and Services for Nuclear Power Plants N45.2.23-Qualification of Quality Assurance Program Audit Personnel for Nuclear Power Plants NQA-1-1994 WITH 1995(a) ADDENDA QUALITY REQUIREMENTS for NUCLEAR POWER FACILITY APPLICATIONS QA AS ESTABLISHED BY REGULATORY RULEMAKING TITLE 10, APPENDIX B to PART 50 Quality Assurance Criteria for Nuclear Power Plants & Reprocessing Facilities “ Quality Assurance Comprises All Those Planned and Systematic Actions Necessary to Provide Adequate Confidence That a System, Structure or Component Will Perform Satisfactorily in Service” Quality Assurance includes Quality Control, Which Comprise Those Quality Assurance Actions Related to The Physical Characteristics Of A Material , Structure , Component , or System Which Provides A Means To Control The Quality Of The Material, Structure Component Or System To Predetermined Requirements. Slide 7 QUALITY REQUIREMENTS ESTABLISHED BY REGULATORY RULEMAKING TITLE 10 APPENDIX A TO PART 50 Criteria 1. – Quality Standards and Records. Structures, Systems , and Components Important To Safety Shall Be Designed, Fabricated, Erected and Tested to Quality Standards Commensurate With The Importance Of The Safety Functions To Be Performed. Where Generally Recognized Codes and Standards Are Used , They Shall Be Identified And Evaluated To Determine The Applicability, Adequacy, And Sufficiency And Shall Be Supplemented Or Modified As Necessary to Assure A Quality Product In Keeping With The Required Safety Function. A Quality Assurance Program Shall be Established And Implemented In Order To Provide Adequate Assurance That These Structure, Systems, And Components Will Satisfactorily Perform Their Safety Functions. Appropriate Records Of The Design,Fabrication, Erection, And Testing Of Systems, Structures And Components Important To Safety Shall Be Maintained By Or Under The Control Of The Nuclear Power Unit Licensee Throughout The Life Of The Unit. Slide 8 OTHER DAUGHTER STANDARDS • • • • • • • Incorporated into NQA-2-1983 N45.2.1 Fluid Systems N45.2.2 Packaging & Handling N45.2.3 Housekeeping N45.2.5 Civil / Structural Inspection N45.2.8 Mechanical Equipment Inspection N45.2.15 Hoisting & Rigging N45.2.20 Subsurface Investigations Slide 9 NQA STRUCTURE – Part I, “Requirements” ( sometimes referred to as “basic requirements”) which coincide with the 18 Criteria contained in 10CFR50, Appendix B. – Part II, ”Requirements” ( formerly NQA-2, various daughter standards) – Part III, “Non-mandatory Guidance” ( formerly Non-mandatory Appendices to Slide 10 DEVELOPMENTAL MILESTONES • Performance Based vs. Compliance • Graded Approach • Risk Informed Slide 11 PERFORMANCE BASED INITIATIVE 1993 SAN DIEGO TASK FORCE FORMED • • • • SEVEN CRITERIA FOR REWRITE OF PART I Is it performance base related Does it contribute to safe/reliable plant ops Is benefit commensurate with implementation cost • Is it consistent with current technology and industry maturity • Is the level of detail required to achieve desired result Slide 12 PERFORMANCE BASED (CONTINUED) • For the intended activity, is this a minimum requirement that applies to all applications • Is the requirement stated once and not duplicated Application of these seven criteria were intended to move the focus from “Compliance “ to the verification of the “Attainment of safety and reliability” Slide 13 PERSPECTIVE ON MISSION Nuclear Regulatory Commission Nuclear Industry • SAFETY • LICENSABLE • CONSERVATISM •SAFETY • COMPLIANCE • FUNCTIONALITY • PAPER TRAIL • RELIABILITY • LICENSABLE • COMPLIANCE 1993-NQA Committee Performance Based Initiative VERIFICATION OF COMPLIANCE nqa1.history.4. FOCUS Slide 14 ATTAINMENT OF SAFETY AND RELIABILITY FUTURE NQA APPLICATIONS • Advanced & Generation IV Reactors • Fuel Production Facilities • Thermonuclear Power Projects Slide 15 NQA COMMITTEE Main Committee (35 Members) • • • • SC on Assessment & Verification SC on Waste Management SC on Applications SC on Engineering and Procurement Processes • SC on Program Management Processes • SC on Interface and Administration FUNCTIONS • • • • • • • Maintain the NQA documents Planning for changes and new documents Balloting changes and new documents Responding to Inquiries Working with Regulators Outreach to Users Balance of Interest Slide 17 FEATURES • Two meetings a Year • Electronic Ballot Process • Member Performance Evaluation • Consideration of All positions • Open Process Slide 18 NQA – 1 QUALITY ASSURANCE REQUIREMENTS FOR NUCLEAR FACILITY APPLICATIONS Presented By – Robert G. Burns, PE 32nd National Energy & Environmental Division Conference in San Antonio , Texas THINGS YOU WONT FIND IN NQA-1 HELPFUL QA SURVIVAL HINTS AUDIT STRATEGIES • PLAN A BE LUCKY • PLAN B BE DECEPTIVE • PLAN C BE COMPLIANT BEST STRATEGY: • ACCEPT RESPONSIBILITY - BE ACCOUNTABLE • RESPOND IN RELATION TO SEVERITY - MOST CRITICAL-SAFETY - NEXT IS FUNCTIONALITY - LAST IS COSMETIC COMPLIANCE • CONTEND INANE FINDINGS- THEY REFLECT BADLY ON THE AUDITOR AND YOU. REMEMBER A NONSENSE FINDING IS OFTEN IMPOSSIBLE TO ANSWER LOGICALLY! Slide 21 AUDIT MANAGEMENT • PRESENTATIONS • LUNCHES & DINNERS • FACILITY TOURS • NON-AUDIT DISCUSSIONS FALL-BACK STRATEGY • “NEW SYSTEM” • “ PLEAD GUILTY TO EASY TO FIX ERRORS” • “CONTEND THEN SURRENDER” • “ PRAY FINDING TRACKS TO PREVIOUS QA MANAGER” Slide 22 SELLING AN NQA QUALITY PROGRAM OR PLAN • PLAY CLIENT MUSIC & LYRICS • BUILD FLEXIBILITY INTO TEXT – Shall, Should May • MAXIMIZE USE OF DIAGRAMS, MAPS, FLOWCHARTS • SELL THE PROGRAM AS A PRODUCT • IT’S NOT BIBLICAL – Plan for Revision • ASSESS EFFECTIVENESS COST TO IMPLEMENT SCHEDULE IMPACT USER BUY-IN DISCIPLINE / ACCOUNTABILITY • RESELL THE PROGRAM & Reach Beyond Compliance Slide 23 DEVELOPMENT DANGER - THE IMPROVEMENT DEATH SPIRAL Investigate Resume Investigation Plan New Approach Implement New Approach Degrade to Original Practice Measure Improvement Modify New Approach Find Any Non-Improvement Slide 24