ML24047A185
| ML24047A185 | |
| Person / Time | |
|---|---|
| Issue date: | 01/24/2024 |
| From: | Kevin Heller, John Lehning, Ngola Otto Licensing Processes Branch |
| To: | |
| References | |
| Download: ML24047A185 (14) | |
Text
Lessons Learned from the U.S. NRC Staffs Review of Framatome Topical Report ANP-10339P, ARITA - ARTEMIS/RELAP Integrated Transient Analysis Methodology January 24, 2024 K. Heller, DSS J. Lehning, DSS N. Otto, DORL
2 Background
- ARITA is a complex methodology for analyzing a wide array of SRP Chapter 15 events (excluding LOCA and rod ejection).
- Multiple challenges were encountered during the review.
- Multiple topical areas united into one method
- Unique vendor-proposed approaches
- Resource limitations
- Multiple schedule extensions to support:
- Vendor preparation and submittal of topical report
- Vendor responses to RAIs
- Staff preparation of SE
- NRC initiated a lessons learned assessment based on the evolution of the ARITA review.
- Framatome supported the lessons-learned assessment by providing its own assessment of lessons learned and recommendations.
3 Review Timeline FRAMATOME NRC ANP-10339P Submitted Aug 2018 Acceptance Review Complete Nov 2018 Acceptance Review Supplement Mar 2019 Onsite Audit Sept 2019 Batch 1 RAIs (13)
Issued Dec 2019 Prospective L&Cs First Discussed Dec 2020
Response
to 13 RAIs Mar 2020
Response
to 37 RAIs Jul 2020
Response
to 16 RAIs Dec 2020
Response
to 26 RAIs May 2021 Updated Topical Report / Final RAI Response Jun 2022 Batch 2 RAIs (79)
Issued Apr 2020 Draft SE Apr 2023 2018 2019 2020 2021 2022 2023 19 Audits & Meetings to Resolve RAIs Nov 2020 - April 2022 Acceptance Supplement Detailed Review RAI Resolution Draft SE ACRS Mtgs Jun/Jul 2023 Final SE Oct 2023
4 Lessons Learned Key Points
- The NRC management and staff should:
- Follow existing processes (e.g., acceptance review, RAI resolution)
- Improve existing guidance w/ respect to non-acceptance criteria (e.g., completing a review should be possible w/o excessive resources)
- Improve planning for reviews with complex technical issues
- Improve adherence to issue resolution milestones
- Improve documentation and communication with all stakeholders (e.g., effectively communicate TR review prioritization)
5 Recommended Actions
- Minimize deviations from guidance and review processes.
- Integrate Lessons-Learned into next update of LIC-500 (i.e.,
limited scope update)
- Explicitly document basis for schedule and resources, and basis for any changes to schedule.
- Develop a detailed tracking list for complex reviews to document the status and resolution of each RAI.
- Effective communication tool for alignment of follow-up actions
- Significantly enhanced both internal and external discussions
- Potential opportunity to leverage the RAI-app
- Establish and adhere to deadlines for RAI responses/resolution of technical concerns.
6 Framatome Recommendations
- The NRC staff is considering Framatomes review process recommendations for the next revision to LIC-500.
- Meeting Summaries and Audits
- The NRC staff plans to ensure appropriate documentation for audits and public meetings.
- Resolution of Technical Issues
- The NRC will continue to use its organizational values and regulatory requirements in decision-making for resolving technical issues.
- Reasonable Assurance Guidance
- Reasonable assurance is a legal standard that predates nuclear industry and is incorporated into the Atomic Energy Act of 1954.
- NRC staff has recently issued expectations for how to approach reviews to achieve a reasonable assurance standard.
7 Questions?
8 Follow Existing Processes
- Issues:
- The original submittal did not meet the acceptance criteria for TRs which led to supplemental information.
- Lessons Learned:
- The NRC staff should more strictly adhere to guidance (LIC-500, LIC-109) for acceptance reviews (regarding readily available information and resolution of information insufficiencies) and formal reviews.
- Actions:
Deviations from acceptance review guidance should be minimized Acceptance of an application for formal review should not be based on availability of information that has not been independently assessed for completeness.
Deviations from the current topical report formal review process should be minimized.
9 Improve Existing Guidance
- Issues:
The NRC staff could not accurately estimate the initial review schedule and resources because of the need for supplemental information and the identification of several challenging technical issues with uncertain resolution timelines.
Consequently, the NRC staff could not determine the magnitude of resources and schedule changes needed to overcome challenges during the review.
Lessons Learned:
LIC-500 guidance should be updated to be clearer regarding non-acceptance of applications.
Submittal content and quality criteria.
Reasonable assurance that a formal review can be completed without excessive resources or burdensome limitations and conditions.
Action:
Update LIC-500 guidance to address content and quality of applications.
Confirm with reasonable assurance that a formal review can be completed on mutually agreeable schedule without burdensome limitations and conditions.
10 Improve Planning for Complex Reviews Issues:
- The initial review schedule was a best estimate based on the information at that time, but NRC staff was unable to quantify impacts based technical issues that had not yet been identified in requests for additional information (RAIs).
Lessons Learned:
- The NRC staff should improve the comprehensiveness and realism of review schedules in the acceptance letter that consider RAI response times and resources based on the review complexity.
Actions:
- The NRC staff and applicants should establish schedules for responding to RAIs.
- For complex reviews, the NRC staff and applicants should budget additional time and resources.
- Use LIC-115 guidance for issuance and response timeliness of RAIs.
11 Improve Adherence to Issue Resolution Milestones Issues:
- Schedule and resources were revised on multiple occasions based on delays and challenges in resolving technical issues during the review.
Lessons Learned:
- The NRC staff should improve the monitoring and management of review schedules and resources when faced with challenging technical issues.
Actions:
- The NRC staff should establish firm resolution deadlines for technical issues and ensure they are not exceeded.
- Preparing limitations and conditions to address unresolved technical issues.
- Stopping the review if technical issues take excessively long to resolve.
- Concluding the review by completing the draft safety evaluation with consideration of an inadequate safety determination.
12 Improve Documentation and Communication Issue:
- Challenges impacted schedules, and/or resources were not adequately documented and effectively communicated with all stakeholders.
Lessons Learned:
- The NRC staff should improve documentation and communication with all stakeholders when challenges are encountered that impact schedules, resources, or both.
- The NRC staff should communicate clearly and effectively, both internally between management and technical staff and externally between NRC staff and stakeholders, on the prioritization of the TR review.
- The NRC staff should explicitly document in the acceptance review letter any identified emergent complexities or challenges that could impact the review.
- Communicating safety issues early and establishing information needs for timely resolution.
13 Improve Documentation and Communication
- Actions:
- Communication should take the form of an official letter.
- Challenges and schedule and resource impacts should be clearly identified, including instances when the applicant requests extension of a review.
- Internal communication should include clear prioritization of all applicable work products.
- Any deviations from the acceptance review process or current TR formal review process should be thoroughly documented and clearly justified.
- Review schedule assumptions should be clearly identified.
- The NRC staff will continue to use pre-submittal discussions to assure that potential issues are identified as early as possible.
- Early communication of safety issues and concerns.
14 Framatome Lessons Learned Alignment with review schedule, scope, and commitments Management oversight, early escalation, and define the escalation process within LIC-500 Develop preliminary SE at the onset of the review in accordance with LIC-500 Framatome Recommendations Revise LIC-109/LIC-500 to address the following:
Use of a preliminary SE with open items prior to issuance of RAIs will aid in determining what information is needed to make a safety and regulatory finding on the report.
Management oversight, early escalation, and the escalation process need to be defined within LIC-500.
Publish detailed meeting and audit summaries including an Issue Resolution Map to assure agreements are addressed and retained.
Ensure traditional audits are utilized where underlying calculations are reviewed and interactions with technical experts are performed to resolve concerns are performed.
Framatome Recommendations Allow audit reports with RAI responses to be used in final -A version without the need for a formal RAI and RAI response.
Provide instructions on revising acceptance review milestones in the event original milestones are exceeded.
Provide the Technical Evaluation Report with the draft SE when subcontractors are used to assure transparency and completion.
Reference topical report information in lieu of repeating in the final SE.
Allow vendors to create NP version of final SE to reduce time and expense.
Develop an appeal process to address significant and unresolved disagreements between NRC Staff and Framatome Technical Staff positions as well as between NRC Staff and Contractor positions.
A written Issue Resolution Map with NRC tracking to adequate resolution should be kept and distributed to Framatome and NRC Staff so that all are aware of the resolution status of each item.
Develop guidance on what constitutes reasonable assurance for use by NRC Staff and share with industry.