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NEI Presentation for Alternative Approach to Use Suppliers with a Commercial Quality Program (ISO-9001)
	ML21327A263
Person / Time
Site:	Nuclear Energy Institute
Issue date:	11/30/2021
From:	; Nuclear Energy Institute
To:	Yiu Law; NRC/NRR/DRO/IQVB
	Law Y
References
	ISO-9001
	Download: ML21327A263 (24)
	v • d • e

Alternative Approach to Use Suppliers with a Commercial Quality Program (ISO-9001)

NRC Public Meeting:

Nuclear Energy Institutes Concept for Quality Assurance Standard ISO-9001 November 30, 2021 Nuclear Energy Institute

©2021 Nuclear Energy Institute Introduction and Overview Mark Richter-NEI What we are proposing and why Develop an approach and strategy to utilize a supplier with ISO -9001 certification to meet the requirements of 10 CFR Part 50 Appendix B

Addresses necessary growth of the AR supplier community

Drives innovation for emergent AR technologies

Reduces economic challenges to small suppliers posed by development of Appendix B Program

©2021 Nuclear Energy Institute 3 Introduction and Overview Initial effort focused on guidance to support Part 53 More efficient to develop a free-standing approach that will support Part 53 QA requirements, while enabling potential near term applications Forward path will include NEI Guidance as well as other means to seek NRC endorsement Opportunities to support industry now Suppliers certified to ISO-9001

Expand the community of suppliers available to the Advanced Reactor community

Improve supply chain performance and efficiency Possible Near - Term Benefits to Operating Fleet

Address concerns with obsolescence and shrinking supplier pool

Support modernization efforts Continue focus on preserving reasonable assurance

Suppliers often have both ISO -9001 & 10CFR50, Appendix B programs

ISO-9001 quality programs are often modified to include 10CFR50, Appendix B

Example: Corrective Action

ISO-9001 provides for analysis and evaluation of products/services, customer satisfaction, and performance of the quality program.

10CFR50, Appendix B, is specific on identifying conditions adverse to qualityfailures, malfunctions, deficiencies, deviations, etc., such as

Items being manufactured for use as nuclear safety-related may require more rigor in the area of corrective action.

Current Process for Using ISO-9001

Example: Control of Special Processes

ISO-9001 does not provide a discussion on Special Processes

10CFR50, Appendix B provides specific instructions for control of welding, heat treating, and nondestructive testing, are controlled and accomplished by qualified personnel using qualified procedures.

Items being manufactured for use as nuclear safety-related will require specific instructions for the control of Special Processes in contracts/purchase orders.

Current Process for Using ISO-9001

Going forward:

Recognize the wide acceptance of the ISO-9001 quality program

Recognize customers historically get consistent, good-quality products and ser vices

Address gaps (ISO vs App B) through additional procurement requirements/specifications

Gaps will vary based on reactor designs and need to be addressed on a case-by-case basis Current Process for Using ISO-9001

Going forward:

Will require tailored assessments based on the identified gaps

Targeted scope rather than a full App B audit scope

Designed specifically for the item/component

Industry cooperation regarding oversight Industry App B/ISO-9001 gap analysis

10CFR50, Appendix B ISO-9001 I - Organization No significant gaps, independence to identify quality concerns may need to be addressed II - Quality Assurance Program No significant gaps

III - Design Control Reviews and Verification may be able to provide an equivalent to Independence Reviewer IV - Procurement Document Control Ensure the requirements are passed down to the sub-contractors

V - Instructions, Procedures, and Drawings No significant gaps

VI - Document Control No significant gaps

VII - Control of Purchased Material, Equipment, and Services No significant gaps Industry App B/ISO-9001 gap analysis

10CFR50, Appendix B ISO-9001 VIII - Identification and Control of Materials, Parts, and Components No significant gaps identified

IX - Control of Special Processes May require specific instructions for the control of Special Processes

X - Inspection Development of specific witness and hold points

XI - Test Control No significant gaps identified

XII - Control of Measuring & Test Equipment No significant gaps identified

XIII - Handling, Storage, and Shipping No significant gaps identified

XIV - Inspection, Test and Operating Status No significant gaps identified XV - Nonconforming Material, Parts, or Components No significant gaps identified Industry App B/ISO-9001 gap analysis

10CFR50, Appendix B ISO-9001 XVI - Corrective Action May need more rigor for identifying conditions adverse to quality

XVII - Quality Assurance Records No significant gaps

XVIII - Audits No discussion of External Supplier Audits Alternative Approach to the Use of ISO -9001 Certified Suppliers Marc Tannenbaum -EPRI Alternative Approach to the Use of ISO-9001 Certified Suppliers

m Why focus on ISO-9001?

Widen the pool of suppliers and equipment available for use in advanced reactors

Decrease in nuclear suppliers in the US and worldwide

Existing nuclear Suppliers are reacting to reduced demand

Speed manufacture and deployment of new nuclear technologies

Quicker achievement of net zero emissions in the US

ISO-9001 is essentially a de facto requirement for industry

Many high-quality industrial manufacturers are already accredited

Those not willing to fully implement a nuclear QA program may consider and option based on existing commercial program

m Basic Premises for Consideration of ISO-9001 Certified Programs

Supplier s product meets

Suitability of design is established design requirements

Acceptance requirements

Should be the case for new design/construction are known for the supplier s

Available for assessment

Supplier has accredited QA

Provides baseline for assessment p ro g ra m

Enables use of QA comparisons (ISO vs. App. B)

Rights of access to supplier s

Assessment and oversight facility

m Basic Approach

Identify items in scope of supply

Identify applicable quality e.g. Appendix B criteria criteria

Develop targeted Particular focus on areas of assessment disparity between 10CFR50, Appendix B and accredited program requirements

Identify gaps Where is buttressing required?

Develop/Execute Generic template Inspection and Enables buttressing Can include activities performed by Test Plan supplier or, licensee

m Future Possibilities

If industry oversees the commercial quality SECY 03-117 programs accreditation process, NQA-1, Part IV, Subpart 4.1 assessment scope could focus on areas of NUPIC experience assessing ISO certificate holders disparity between ISO and Appendix B Additional Comparisons

Help operating fleet address obsolescence and modernization

Establish nuclear industry accreditation capabilities

m TogetherShaping the Future of Energy '

m Closing Comments Mark Richter-NEI Opportunities Are Here Today

Increasing recognition for carbon-free energy sources driving deployment of advanced reactors Energy markets remain competitive and volatile, affirming need to preserve operating fleet and sustain it with improved performance and efficiency Transformational approaches to Quality Assurance are needed by industry, codes and standards and regulatory communities to grow supplier pool, enhance supply chain performance and competition and achieve improved supplier performance

©2021 Nuclear Energy Institute 22 What we are proposing and why Develop an approach and strategy to utilize a supplier with ISO -9001 certification to meet the requirements of 10 CFR Part 50 Appendix B

Addresses necessary growth of the AR supplier community

Drives innovation for emergent AR technologies

Reduces economic challenges to small suppliers posed by development of Appendix B Program

ML21327A263

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