ML20085H794

MP3: NEI 17-06 - Review: QA Aspects of SIL Certification - Public Meeting April 1, 2020

ML20085H794
Person / Time
Site:	Nuclear Energy Institute
Issue date:	04/01/2020
From:	Nuclear Energy Institute
To:	Office of Nuclear Reactor Regulation
Holonich J
References
MP3: NEI 17-06
Download: ML20085H794 (14)

Text

MP3 : NEI 17-06 Review QA Aspects of SIL Certification April 01, 2020

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Quick Review of NEI 17-06 Process

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CBs & ABs

• Certification Bodies (CBs) have a standardized, rigorous, and reliable evaluation process

• Accreditation Bodies (ABs) ensure CBs are consistent and trustworthy

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The EPRI Report- Section 3 of NEI 17-06

• SIL Certification Aligns Well With EPRI TR-106439 EPRI TR-106439 SIL Certification- Safety Case Development Personnel Qualifications/ Experience HW/SW Design, Development, Verification & Validation Processes Availability/Reliability Requirements Failure Modes Analysis/ Testing/ Management Design Documentation Configuration Management Quality Assurance SW Requirements Definition & Requirements Traceability Vendor Testing (Performance, Environmental, SW V&V, Fault Insertion)

Product Operating History Error Tracking/ Problem Reporting

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COTS Justification Process Overview

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Justification Process- Section 4 of NEI 17-06 Review of SIL Certification Review of SIL Not replacing CGD Certification

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How to Address QA Aspects of NEI 17-06 Process

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Accreditation Replaces Commercial Grade Survey of SIL Certifier Service

• Accreditation of SIL Certifier to ISO 17065 should be comparable to the NRC accepted practice for commercial grade surveys as a method of CGD of a service

• NEI 17-06 will describe how ISO/IEC-17065 requirements address the quality activities included in a commercial grade survey addressing the CC associated with the service provided by the certifier

• Any identified gaps will be justified, or compensating measures defined

• SIL Certifier accredited by AB to ISO/IEC-17065 Similar to Calibration Service accredited by AB to ISO/IEC-17025 NRC, in ML14322A535, finds that the ILAC accreditation process

[based on ISO/IEC-17025] continues to satisfy the requirements of Appendix B to 10 CFR Part 50 and, therefore, is acceptable.

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Comparison of Methodologies Dedication of Testing/Calibration Service with Dedication of a Programmable Digital Device with Accreditation (NEI 14-05) Accreditation and Certification (NEI 17-06)

Periodic Oversight Periodic Oversight by US Nuclear Accreditation Body by US Nuclear Accreditation Body Industry Industry Accreditation Accreditation Licensee Licensee Or Dedicating Entity Or Dedicating Entity Calibration Lab *CGD of Service Certification Body

• CGD of Service ISO 17025 ISO 17065

• CGD of Equipment/

Components Calibration Certificate - Dependability CCs } SIL Certificate Calibration Service Evaluation Service

-Performance CCs

-Physical CCs } Traditional EPRI Methods Equipment/ Equipment/ OEM Components Components IEC 61508

• Note that CGD activities include a technical evaluation

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NEI 17-06 Methodology

• The service provided by the SIL certifier will be dedicated Each time a programmable digital device (PDD) SIL certification is used to support a CGD, a CGD package is prepared to dedicate the service provided by the SIL certifier.

The CGD package credits the SIL certifiers AB accreditation to conclude the certifying service is equivalent to nuclear grade.

The specific SIL certification becomes acceptable for use (from a QA perspective).

The accepted SIL certification is then used to confirm acceptability of the dependability CCs in the CGD of the PDD. ©2020 Nuclear Energy Institute 10

NEI/Licensee Responsibilities

• NEI 17-06 will evaluate for any gaps between ISO/IEC-17065 quality activities and the commercial grade survey quality activities (in respect to CCs of the certifiers service), and will either justify the gaps or identify licensee compensating measures for the gaps

• When ISO/IEC 17065 is revised, NEI will evaluate the changes for impact to NEI 17-06 evaluation

• The licensee, on a periodic basis, will observe the ANSI or DAkkS accreditation of CBs to ISO/IEC-17065 Similar to ILAC process of licensee observing AB accreditation of calibration services to ISO/IEC-17025 Observations will include documentation review of previous certifications performed by the certifier

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Future Work, After NEI 17-06 Acceptance of a Programmable Digital Device with an

• 10CFR50 App B procurement ISO 17065 Accredited IEC 61508 Certification requirements (Section IV & VII)

Periodic Oversight satisfied by ISO 17065 accredited by US Nuclear Accreditation Body Industry certification to IEC 61508 Accreditation

• 10CFR50 App B does not require Licensee Or Dedicating Entity that suppliers have a 10CFR50 Certification Body ISO 17065 App B QA program. That is just 10CFR50 App B how the industry has Section IV. Procurement Document Control SIL Certificate Evaluation Service implemented it. Section VII. Control of Purchased Material, Equipment, and Services Equipment/ OEM Components IEC 61508

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©2020 Nuclear Energy Institute 13 MP3 Schedule Task Resource Due Date Public Meeting on MP3 - NEI 17-06 NRC/NEI 4/01/2020 NEI submits NEI 17-06, rev. C for NRC Review NEI 5/29/2020 Public Meeting on MP3 - NEI 17-06 NRC/NEI June 2020 Comments issued on NEI 17-06, rev. C NRC TBD NEI submits NEI 17-06, rev. 0 for NRC Review NEI TBD Issue RAIs for NEI 17-06, rev. 0 NRC TBD Respond to NRC RAIs and re-submit revised NEI 17-06, rev. 0 NEI TBD Issue SER on NEI 17-06, rev. 0 NRC TBD Publish NEI 17-06, rev. 0 including NRC SER NEI TBD

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