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{{#Wiki_filter:Alternative Approach to Use Suppliers with a Commercial Quality Program (ISO-9001) | {{#Wiki_filter:Alternative Approach to Use Suppliers with a Commercial Quality Program (ISO-9001) | ||
NRC Public Meeting: | NRC Public Meeting: | ||
Nuclear Energy Institutes Concept for Quality Assurance Standard ISO-9001 November 30, 2021 Nuclear Energy Institute | Nuclear Energy Institutes Concept for Quality Assurance Standard ISO-9001 November 30, 2021 Nuclear Energy Institute | ||
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 | ©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 | * Addresses necessary growth of the AR supplier community | ||
* Drives innovation for emergent AR technologies | * Drives innovation for emergent AR technologies | ||
* Reduces economic challenges to small suppliers posed by development of Appendix B Program | * Reduces economic challenges to small suppliers posed by development of Appendix B Program | ||
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 | ©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 | ||
Introduction and Overview No change in original goal: Support Advanced Reactor Development and Deployment | ©2021 Nuclear Energy Institute 4 Introduction and Overview No change in original goal: Support Advanced Reactor Development and Deployment | ||
* Expand the community of suppliers available to the Advanced Reactor community | * Expand the community of suppliers available to the Advanced Reactor community | ||
* Improve supply chain performance and efficiency Possible Near -Term Benefits to Operating Fleet | * Improve supply chain performance and efficiency Possible Near - Term Benefits to Operating Fleet | ||
* Address concerns with obsolescence and shrinking supplier pool | * Address concerns with obsolescence and shrinking supplier pool | ||
* Support modernization efforts Continue focus on preserving reasonable assurance | * Support modernization efforts Continue focus on preserving reasonable assurance | ||
ISO-9001: Current Use and Examples Mark Coren-Duke Energy | ©2021 Nuclear Energy Institute 5 ISO-9001: Current Use and Examples Mark Coren-Duke Energy Current Process for Using ISO-9001 Nuclear Safety-Related | ||
* 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. | * 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 | * 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. | 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 | * 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. | * 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. | 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 the wide acceptance of the ISO-9001 quality program | ||
* Recognize customers historically get consistent, good-quality products and | * Recognize customers historically get consistent, good-quality products and ser vices | ||
* Address gaps (ISO vs App B) through additional procurement requirements/specifications | * 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 | * 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 | * Will require tailored assessments based on the identified gaps | ||
* Targeted scope rather than a full App B audit scope | * Targeted scope rather than a full App B audit scope | ||
* Designed specifically for the item/component | * Designed specifically for the item/component | ||
* Industry cooperation regarding oversight | * 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 | |||
Alternative Approach to the Use of ISO-9001 Certified Suppliers Marc Tannenbaum-EPRI | 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 | ||
www.epri.co © 2021 Electric Power Research Institute, Inc. All rights reserved. | |||
m | m Why focus on ISO-9001? | ||
Widen the pool of suppliers and equipment available for use in advanced reactors | Widen the pool of suppliers and equipment available for use in advanced reactors | ||
* Decrease in nuclear suppliers in the US and worldwide | * 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 | * 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 | * 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 16 | * Those not willing to fully implement a nuclear QA program may consider and option based on existing commercial program | ||
16 www.epri.co © 2021 Electric Power Research Institute, Inc. All rights reserved. | |||
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 | |||
* Provides baseline for assessment | |||
* Enables use of QA comparisons (ISO vs. App. B) | * Enables use of QA comparisons (ISO vs. App. B) | ||
Basic Approach Identify items in scope of supply Identify applicable quality e.g. Appendix B criteria criteria Develop targeted | Rights of access to supplier s | ||
Develop/Execute | * Assessment and oversight facility | ||
17 www.epri.co © 2021 Electric Power Research Institute, Inc. All rights reserved. | |||
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 | |||
18 www.epri.co © 2021 Electric Power Research Institute, Inc. All rights reserved. | |||
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 | |||
19 www.epri.co © 2021 Electric Power Research Institute, Inc. All rights reserved. | |||
m TogetherShaping the Future of Energy ' | |||
Closing Comments Mark Richter-NEI | 20 www.epri.co © 2021 Electric Power Research Institute, Inc. All rights reserved. | ||
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 | |||
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 | ©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 | * Addresses necessary growth of the AR supplier community | ||
* Drives innovation for emergent AR technologies | * Drives innovation for emergent AR technologies | ||
* Reduces economic challenges to small suppliers posed by development of Appendix B Program | * Reduces economic challenges to small suppliers posed by development of Appendix B Program | ||
Discussion}} | ©2021 Nuclear Energy Institute 23 Discussion}} | ||
Latest revision as of 04:15, 19 November 2024
| 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) | |
Text
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
©2021 Nuclear Energy Institute 4 Introduction and Overview No change in original goal: Support Advanced Reactor Development and Deployment
- 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
©2021 Nuclear Energy Institute 5 ISO-9001: Current Use and Examples Mark Coren-Duke Energy Current Process for Using ISO-9001 Nuclear Safety-Related
- 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
www.epri.co © 2021 Electric Power Research Institute, Inc. All rights reserved.
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
16 www.epri.co © 2021 Electric Power Research Institute, Inc. All rights reserved.
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
Rights of access to supplier s
- Assessment and oversight facility
17 www.epri.co © 2021 Electric Power Research Institute, Inc. All rights reserved.
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
18 www.epri.co © 2021 Electric Power Research Institute, Inc. All rights reserved.
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
19 www.epri.co © 2021 Electric Power Research Institute, Inc. All rights reserved.
m TogetherShaping the Future of Energy '
20 www.epri.co © 2021 Electric Power Research Institute, Inc. All rights reserved.
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
©2021 Nuclear Energy Institute 23 Discussion