ASME Nuclear Conformity Assessment

2. ASME Nuclear Conformity Assessment Kevin Ennis Director, Nuclear Codes and Standards

3. ASME Nuclear Conformity Assessment • What is it? • Why is Conformity Assessment Important? • Who is involved? • What are the steps in the process? • How does Conformity Assessment fit into the nuclear industry?

4. Conformity Assessment - Defined • Definition (from ISO/IEC 17000) • Demonstration that specified requirements relating to a product, process, system, person or body are fulfilled • Examples: testing, inspection, certification, registration, accreditation • Simply: • Programs, processes and procedures for demonstrating compliance with Section III of the ASME Boiler and Pressure Vessel Code • Product Certification • Nuclear Components • Materials

5. Conformity Assessment - Defined

6. Conformity Assessment - Defined Quality System Certificate • Material Manufacturers and Material Suppliers • Supply material to nuclear component manufacturers • Examples: • Bars, fasteners, castings, forgings, plates, fittings, flanges, tubular products • Wire, rod, billets, ingots • Welding material • Concrete reinforcing bars, prestressing components

7. Conformity Assessment - Defined • Types of Certificates • Accreditation – Approval of QA Program • Accreditation – Quality System Manufacture and Supply of Material • Authorization – Component Manufacture • Authorization – Supports

8. Conformity Assessment - Defined • ASME Certifies the manufacturer • Manufacturer certifies the product

9. Importance of Conformity Assessment • History • Industrial Revolution ~ late 1800’s • Steam power to 1910 • Explosions • Early Regulations • ASME Boiler Code – 1915 • Conformity Assessment – S, A and PP Stamps • Interstate Commerce • Global Trade

10. Importance of Conformity Assessment • Conformity assessment process ensures: • Products, services, or systems have the required characteristics (i.e., meet Code requirements) • Characteristics are consistent from product to product, service to service, or system to system

11. Importance of Conformity Assessment • Conformity assessment process enables: • Manufacturers have access to markets • Purchasers to have confidence that products will be acceptable for use (regulations and liability insurance) • Regulatory Authorities to have confidence that equipment is safe to operate • Organizations to have recourse for bringing products into compliance with the Code

12. Importance of Conformity Assessment • Conformity assessment process assists in: • Supply chain management • Last Build – US technology with US suppliers (mostly) • New Build – global supply chains • New Build – global suppliers (As an example, a component may be assembled and certified in the US but the parts may come from all over the world.)

13. Conformity Assessment Organizations • Organizations Involved: • Regulatory Authorities • NRC • Jurisdiction • Certification Bodies • ASME • National Board of Boiler and Pressure Vessel Inspectors (National Board) • Third Party Inspection Agency • Authorized Nuclear Inspection Agency (ANIA) • Certificate Holder • Manufacturer

14. Conformity Assessment Organizations • Regulatory Authorities: • Nuclear Regulatory Commission • Endorse the Code as an acceptable means of complying with regulation • Member of the Committee on Nuclear Certification • Jurisdictions • Adopt and enforce the Code • Member of the Committee on Nuclear certification • May participate as a member of the survey team

15. Conformity Assessment Organizations • Certification Bodies: • ASME • Promulgates the Code • Certifies Manufacturers • Authorizes the Inspection Agencies (ANIA) • National Board • Examination and Commissioning of Inspectors • May represent the Jurisdictions

16. Conformity Assessment Organizations • Third Party Inspection Agency • Government agencies which adopt and enforce the ASME Boiler and Pressure Vessel Code. “Jurisdictions” • Companies licensed in U.S. or Canada to write Boiler and Pressure Vessel insurance • Accredited by ASME to perform the inspections required by one or more sections of the ASME Boiler and Pressure Vessel Code • Provide third party inspection (oversight) to ensure the ASME Certificate Holder is in compliance with Scope of Authorization • Participate in the survey of the manufacturer

17. Conformity Assessment Organizations • Certificate Holder: • Controlled Manufacturing process • All Examinations • All Tests • Final Certification

18. Conformity Assessment Process 6 Months Application-Preparation 3-5 days Survey 30-90 days Deficiency Correction 3-year cycle 1 week Certification Decision (CNC) Issuance of Certificate

19. Conformity Assessment Process • Application/Preparation: • Applicant applies to ASME • Enters into an agreement with an ANIA • Applicant prepares for the survey • Establishes and implements QA program • Internal audit

20. Conformity Assessment Process • Survey: • Survey Team • ASME Team Leader • 1/2 ASME Team Members • Authorized Nuclear Inspector • Authorized Nuclear Inspector Supervisor • Jurisdiction (invited)

21. Conformity Assessment Process • Survey: • 3-5 Day Survey • Manual review • Entrance meeting • Implementation demonstration • Team findings and recommendations • Exit meeting • Recommendations • Due process

22. User Regulatory Authority Manufacturer Interaction among organization in the nuclear industry Regulation Contract Conformity Assessment Regulation