ML21039A659
| ML21039A659 | |
| Person / Time | |
|---|---|
| Issue date: | 02/10/2021 |
| From: | William Roggenbrodt NRC/NRR/DEX/EICB |
| To: | |
| Roggenbrodt, William 301-415-0678 | |
| References | |
| Download: ML21039A659 (30) | |
Text
Digital Instrumentation and Controls Licensing and Inspection Workshop (Morning Session)
February 10, 2021
2 Workshop Goals
- Provide an update on Digital I&C licensing and inspection activities
- Share lessons learned and insights from the use of ISG-06, Alternate Review Process
- Clarify the scope of licensing and inspection activities associated with the Alternate Review Process
- Request feedback from industry on lessons learned
3 Workshop Agenda (AM)
- Introduction and Workshop Goals
- Digital Modifications Under 10 CFR 50.59
- Licensing Activities
- Overview of Digital I&C Modernization: External
4 Workshop Agenda (PM)
- ISG-06 Alternate Review Process Reflection: NRC
- ISG-06 Alternate Review Process Reflection: Industry
- Open Discussion and Next Steps
- Public Comments
5 DIGITAL MODIFICATIONS UNDER 10 CFR 50.59
6 Tools to Support Digital Upgrades
- RIS 2002-22, Supplement 1, Clarification on Endorsement of Nuclear Energy Institute Guidance in Designing Digital Upgrades in Instrumentation and Control Systems
- NEI 96-07, Appendix D, Supplemental Guidance for Application of 10 CFR 50.59 to Digital Modifications
- RG 1.187, Revision 2, Guidance for Implementation of 10 CFR 50.59, Changes, Tests, and Experiments
- Regional Inspector Training
- Proposed Digital OpE Smart Sample for Inspectors
7 RIS 2002-22, Supplement 1
- RIS 2002-22 Supplement 1, Clarification on Endorsement of Nuclear Energy Institute Guidance in Designing Digital Upgrades in Instrumentation and Control Systems, was issued in May 2018
- Clarifies guidance for preparing and documenting Qualitative Assessments
- Not for replacement of:
- Reactor Protection System (wholesale)
- Engineered Safety Features Actuation System (wholesale)
- Modification/Replacement of the Internal Logic Portions of These Systems
- NEI Industry Workshops conducted in 2nd half of 2018
- NRC inspector training conducted in December 2018 and June 2019
- Public Meeting held in February 2019
- Industry feedback that the RIS guidance was useful for conducting digital mods
8 NEI 96-07, Appendix D
- NEI 96-07, Appendix D, Supplemental Guidance for Application of 10 CFR 50.59 to Digital Modifications, was issued in May 2020 and endorsed by RG 1.187 in June 2020
- Appendix D does not alter and, unless explicitly noted, should not be interpreted differently than the guidance contained in NEI 96-07, Rev. 1. Rather, Appendix D provides focused guidance for the application of 10 CFR 50.59 to activities involving digital modifications. (Section 1.2)
- Appendix D provides the first screening guidance for digital modifications (NEI 01-01 did not have screening guidance).
- Human Factors Engineering (HFE) Evaluation guidance
- NEI industry training in progress. First training was conducted January 20-22, 2021
9 NEI 96-07, Appendix D Endorsement From April 2016 through 2017, the NRC staff and industry participated in monthly public meetings to resolve NRC comments on draft NEI 96-07, Appendix D In December 2017, NEI and the NRC staff mutually agreed to place the review of NEI 96-07, Appendix D on hold to dedicate resources to the issuance of RIS 2002-22, Supplement 1 RIS 2002-22 Supplement 1 was issued on 05/31/18 July - November 2018, resolve comments on Appendix D and issue draft RG 1.187 Revision 2 in May 2019 Draft RG 1.187 had one exception and several clarifications. The exception involved how to evaluate 10 CFR 50.59 Criterion VI (Create the possibility for a malfunction of an SSC with a different result)
From July 2019 - May 2020 work on revising Appendix D so that exception could be removed from draft RG 1.187
10 RG 1.187, Revision 2
- The NRC staff evaluated NEI 96-07, Appendix D, as applied to digital modifications only.
- The NRC staff endorsed NEI 96-07, Appendix D, Revision 1, as a means for complying with the requirements of 10 CFR 50.59 when conducting digital I&C modifications, subject to four clarifications in the RG:
- Relationship to NEI 01-01
- Changes from NEI 96-07, Revision 1
- Human-System Interface
- Use of Acceptance Criteria as Evaluation Results
- Sufficiently Low Likelihood of Software Common Cause Failure
- Appendix D, Section 4.3.6, Step 6: Basic Assumptions and Acceptance Criteria
11 Digital I&C Modification Inspection Training
- Regional Inspector Training was conducted in December 2020 on NEI 96-07, Appendix D; RG 1.187; and a refresher on RIS 2002-22, Supplement 1
- Most digital modifications are inspected through IP 71111.18, Plant Modifications, or 71111.17T, Evaluation of Changes, Tests and Experiments
- For digital modifications that involved a license amendment, IP 52003, Digital Instrumentation and Control Modification Inspection, (IMC 2515 Appendix C) is the correct IP
- Undergoing a revision
- May bring more inspection resources (Vendor Inspection Branch)
- Not a ROP Baseline IP
- New IMC 0355, Changes, Tests, and Experiments was issued on January 29, 2021
- One paragraph on digital I&C mods that point inspectors to NEI 96-07, Appendix D, RG 1.187, and RIS 2002-22, Supplement 1 for digital I&C mods under 50.59 guidance
12 Inspection-Smart Sample Development
- With digital I&C modifications becoming more prevalent NRC inspectors were looking for tools that could help them when inspecting new digital systems
- Staff determined the most efficient course of action would be to develop a digital I&C OpE Smart Sample
- Useful tool providing additional technical guidance for inspectors while inspecting digital I&C systems
- Can be used by inspectors under current ROP baseline inspections
- Working Group formed to develop the smart sample including regional inspectors and technical staff from NRC HQ
13 OPEN DISCUSSION
14 DIGITAL I&C LICENSING
15
- Defines the licensing process used to support the review of licensee amendment requests (LARs) associated with safety-related DI&C equipment modifications in operating plants and in new plants once they become operational.
- Provides guidance for activities performed before LAR submittal and during LAR review. The NRC staff uses the process described in the ISG to evaluate compliance with NRC regulations.
- ISG-06 is used in conjunction with SRP Chapter 7.
ISG-06 Purpose and Scope
16 Revision 1 introduced the concepts of Tiers and Phases:
- Tiers - a general guide for defining the scope or complexity of a review:
- Tier 1 - references a previously approved topical report (TR)
- Tier 2 - references a previously approved TR with deviations
- Tier 3 - does not reference a previously approved topical report
- Phases - a general guide for defining the NRC staff activities to be performed during the review.
- Phase 0 - Pre-Application Meetings with the NRC Staff
- Phase 1 - Initial Application (LAR)
- Phase 2 - Continued Review and Audit (Supplemental Information)
- Phase 3 - Implementation and Inspection ISG-06, Revision 1
17
- ISG-06, Rev. 1 has been used to review the Diablo Canyon Plant Protection System DI&C LAR (ADAMS Accession No. ML16139A008), the Hope Creek Power Range Neutron Monitoring System LAR (ADAMS Accession No. ML17216A022), and DI&C topical report reviews.
- Based on these reviews, the staff identified several improvements that could be made to ISG-06, Rev. 1.
- Industry expressed concerns that:
- Significant resources are required for procuring, developing, and testing a full digital I&C design before the license amendment is issued.
- Several review criteria topical areas were repetitive.
- In 2017, staff formed a working group under the DI&C Integrated Action Plan to revise ISG-06 based on lessons learned and industry feedback.
ISG-06, Revision 1 Lessons Learned
18
- The NRC working group met regularly with industry between 2017 and 2018 to develop the ISG revision.
- The Tier 1, 2 and 3 Review Process was streamlined and eliminated the system planning evaluation criteria.
- The Alternate Review Process (ARP) was introduced.
- Revision 2 focused on the information needed to make the required regulatory findings, instead of the submittal of specific documents.
- A tabletop exercise and an inspection workshop were held to discuss the LAR contents to be developed under the ARP (see next slides).
- ISG-06, Rev. 2 issued on December 2018 in time to support upcoming LARs.
ISG-06, Revision 2
19 Held on June 13-14, 2018 (ADAMS Accession Nos. ML19085A483 and ML19085A484).
Staff and industry went over how specific LAR sections would be developed based on the draft ISG-06, Rev. 2 ARP guidance:
- New System Architecture
- System Development Process
- Pre-application Coordination meetings
- Resolution of Topical Report Plant-Specific Action Items
- Human Factors Engineering
- Secure Development and Operational Environment
- Recommended Inspection Items
- Licensee Commitments
- Vendor Oversight Plan (VOP) Summary
- Improvements were made to the ISG draft based on the tabletop discussions.
Alternate Review Process Tabletop Exercise
20
- Held on November 15, 2018 (ADAMS Accession No. ML19086A059).
- The purpose was to provide clarity on the types of licensing audits and post-license amendment inspections expected to be performed under the ARP.
- Discussed the vendor oversight process and VOP Summary example.
- Discussed the scope of VOP and vendor inspections under the ARP.
- Staff provided a description of the acceptance criteria for design implementation and design outputs in Branch Technical Position (BTP) 7-14 sections B.3.2 and B.3.3 (ADAMS Accession No. ML19087A230).
- Improvements were made to the ISG draft based on the workshop discussions.
Alternate Review Process Inspection Workshop
21 Current DI&C Licensing Activities
- Waterford 3
- Core Protection Calculator System
- LAR submitted on July 2020
- Approval requested by August 2021
- Turkey Point Units 3 & 4
- Reactor Protection System, Engineered Safety Feature Actuation System, Nuclear Instrumentation System
- Pre-submittal meetings on December 2020 and January 2021
- LAR submittal expected in May/June 2021
- Limerick
- Reactor Protection System, Nuclear Steam Supply Shutoff System, Emergency Core Cooling System
- Pre-submittal meeting on June 2020
- LAR submittal expected in September 2022
22 NRC Resource Planning for Major Digital Modernization Projects
- NRC recommends Letter of Intent 6-12 months prior to LAR submittal.
- Reach out through your NRC licensing Project Manager if you intend to submit a Digital I&C amendment in 2021 or 2022.
- Early pre-submittal meetings encouraged to better understand the scope and complexity of planned submittal.
23 Licensing Infrastructure Development
24 Completion of BTP 7-19 Revision 8 Guidance for Evaluation of Defense in Depth and Diversity to Address Common-Cause Failure Due to Latent Design Defects in Digital Safety Systems, (ML20339A647) Issued January 26, 2021.
Addresses the issue of CCF in digital I&C systems with consideration of system safety significance. This allows more flexibility in potential design and analytical solutions to address CCF.
Restructured to improve organization of information and readability.
Refinements within BTP 7-19, Revision 8 Alternative Methods Qualitative Assessment (based upon RIS 2002-22 Supplement 1)
Clarified guidance on Spurious Operation Justification for Not Correcting Specific Vulnerabilities
25 NEI 20-07
- Draft NEI 20-07 proposes an alternative method (i.e. software assurance case) to address software common cause failure (SWCCF) in high safety-significant safety-related (HSSSR) systems and components
- Note: BTP 7-19 is cited as part of staff guidance for the regulatory evaluation under ISG-06, Revision 2
- Staff is currently engaging NEI in pre-submittal interactions to assess the feasibility and potential applicability of the proposed approach.
- First public meeting held on January 12, 2021 (ML21025A392)
26 Planned Updates to Regulatory Guides The staff are striving to improve the clarity and cohesiveness of the I&C regulatory infrastructure o Including more recent and relevant code and consensus standards; and, o Allowing a more effective navigation and use of the available guidance Plans to update the following RGs:
o RG 1.153 to endorse IEEE 603-2018 which includes a new clause addressing CCF that creates a potential to degrade or defeat the safety system function o RG 1.152 to endorse IEEE 7.4-3-2-2016 that includes new guidance for secure development and operational environment (SDOE), Independence (e.g. data communications), hazard identification and software tools o RG 1.168 to assess gradedapproach alternatives for the specified software integrity level guidance and assess the feasibility of consolidating software criteria in RGs 1.168 through 1.173
27 OPEN DISCUSSION
28 ADAMS - Agencywide Documents Access and Management System ARP - Alternate Review Process ASME - American Society of Mechanical Engineers BTP - Branch Technical Position CCF - common cause failure D3 - Defense-in-Depth and Diversity DI&C - Digital Instrumentation and Controls DRA - Division of Risk Assessment FAT - Factory Acceptance Test FMEA - Failure Modes and Effects Analysis GDC - General Design Criteria HW - Hardware HFE - Human Factors Engineering Acronyms
29 Acronyms HSSSR - high safety-significant safety-related IEEE - Institute of Electrical and Electronics Engineers I&C - Instrumentation and Controls IP - Inspection Procedure IRT - Integrated Review Team ISG - Interim Staff Guidance LAR - License Amendment Request MP - Modernization Plan NEI - Nuclear Energy Institute NQA - Nuclear Quality Assurance NRC - Nuclear Regulatory Commission OpE - operational experience QA - Quality Assurance
30 Acronyms RAI - Requests for Additional Information RIS - Regulatory Issue Summary RG - Regulatory Guide SAT - Site Acceptance Test SDOE - Secure Development and Operational Environment SPM - Software Program Manual SW - Software SWCCF - software common cause failure TR - Topical Report TS - Technical Specifications VOP - Vendor Oversight Plan V&V - Verification and Validation