ML23345A079
| ML23345A079 | |
| Person / Time | |
|---|---|
| Site: | 05200050 |
| Issue date: | 12/16/2023 |
| From: | Beverly Smith NRC/NRR/DNRL |
| To: | Renee Taylor Office of Nuclear Reactor Regulation |
| References | |
| Download: ML23345A079 (6) | |
Text
December 16, 2023
MEMORANDUM TO: Robert M. Taylor Deputy Office Director New Reactors Office of Nuclear Reactor Regulation
FROM: Br ian W. Smith, Director /RA/
Division of New and Renewed Licenses OfficeofNuc lear Reactor Regulation
SUBJECT:
NUSCALE STANDARD DESIGN APPROVAL APPLICATION REVIEW INTERIM LESSONS LEARNED REPORT
The purpose of this memorandum is to document lessons learned a nd planned improvements performed by the Division of New and Renewed Licenses (DNRL) st emming from the ongoing NuScale Standard Approval Application Phase A review. The enclo sed interim lessons learned report includes recommendations and specific actions to improve the review process.
The following are the reports major observations:
- The extended audit process has worked well. Many of the issues the staff have raised in the audit would have been communicated as request for additional in formation (RAI) in previous reviews. As audits progress, and the staff is not getting the i nformation needed to make their safety finding, they should move to issue an RAI.
- The staff should be developing their safety evaluation report input throughout the audit review to ensure that they are capturing all the information th at may be missing from the application that is needed to make their safety finding. This w ill allow these information needs to be a part of the audit and, if the staff is at an impa sse with the applicant on the information needed to make a safety finding, issue an RAI. An R AI developed in this manner is, in effect, an open item in the staffs review.
- RAIs should have clear and appropriate background and a descri ption of the issue, specific regulatory basis that is directly related to the question being asked, and specific information needs that will support the staff evaluating the issue and maki ng their safety finding. This should include any specific information that needs to be includ ed in a revised final safety analysis report.
CONTACT: Mahmoud Jardaneh, NRR/DNRL 301-415-4126
R. Taylor 2
The DNRL staff is in the process of implementing the five recom mendations outlined in the report. Please contact Mahmoud Jardaneh, Chief of the New React or Licensing Branch, if you have any specific questions regarding implementation of the rec ommendations.
Docket No. 05200050
Enclosure:
Lessons Learned Report
ML23345A079 *via email NRR-04 3 OFFICE NRR/DNRL/NRLB:PM NRR/DNRL/NRLB: BC* NRR/DNRL/NLIB:LA NRR/DNRL:D NAME GTesfaye MJardaneh SGreen BSmith DATE 12/11/2023 12/12/2023 12/13/2023 12/16/2023 NUSCALE STANDARD DESIGN APPROVAL APPLICATION REVIEW INTERIM LESSONS LEARNED REPORT
M. Mitchell, J. Colaccino, G. Tesfaye
November 2023
The purpose of this document is to identify interim lesson lear ned observations that, if implemented, would improve the review of the NuScale Standard D esign Approval Application (SDAA). The observations focus on the audit process, identifica tion of requests for additional information (RAI) and the development of an advanced safety eva luation report (ASER) with no open items. Improvements that are being suggested include a bet ter-defined transition process between the completion of the audit for each chapter or licensi ng topical report (LTR) to any needed RAIs as well as clear expectations on the development of ASERs to support the identification of RAIs that are needed to make a finding in the safety evaluation report (SER).
The lessons learned report on the review of the NuScale design certification (DC) application (Agencywide Documents Access and Management Systems Accession N o. ML22088A161) highlighted improvements that should be implemented for the use of audits and issuance of RAIs. The report stated that the NRC should use consistent app roaches, such as focused durations; clear and tangible obj ectives; routine schedules for progress reports; and phased approaches that prevent moving on to subsequent portions of aud its before both the applicant and the NRC agree that precursor activities have been satisfact orily completed. The report also discussed improvements to the RAI process incorporated into Rev ision 1 of LIC-115 to enhance the RAI process through greater focus on the regulator y requirements, safety significance, and clarity of RAIs. The report further stated t hat additional opportunities are available to focus the staffs review only on RAIs necessary to support the reasonable assurance finding. Finally, regarding safety evaluations, the report stated that a more concerted effort to streamline SERs at the beginning of the review would further concentrate efforts on the most safety-significant aspects of the design and create a suff icient safety basis for the staffs regulatory conclusions.
The project team charter for the NuScale US460 SDAA implemented these improvements. Of note, the charter specified that in Phase A of the review the N RC would perform audits and develop (1) items that could result as RAIs, and (2) an ASER wi thout open items. Across all the individual chapter and LTR reviews, hundreds of issues have bee n identified and resolved through this process. The Project Managers, Technical Staff, an d applicant have frequently cooperated well and resolved these issues without having to eng age higher levels of management. These activities have been implemented consistent w ith both the lessons learned report and the review. Of the approximately 700 issues that hav e been entered in the audit spread sheet to date for the 19 review chapters and four LTRs, approximately 65% have been resolved during the audit and the remaining are under the NRC r eview, awaiting NuScale response, or converted to a formal RAI. The majority of issues identified in the audit and resolved would have been RAIs in previous similar reviews. Their resolution represents a success in implementing the audit process for this review.
Enclosure
Transitioning issues out of the audit process and into a more f ormalized RAI is addressed in the audit plan. However, in practice, it is clear that more directi on needs to be provided to the staff regarding when to convert an issue into an RAI.
The following are a number of observations that support this as sertion:
- There is an impression among some members of the staff that m anagements message when starting this review was that RAIs were to be avoided and that having to resort to RAIs would be viewed as a failure. While that was almost cert ainly not intended that seems to be what the staff, in many cases, heard.
- Although the audits were executed under the general principle of giving the applicant at least two opportunities to resolve an issue under the audit bef ore elevating it to an RAI, specific review areas for high effort chapters where the staff has reached an impasse in the audit after one round of draft response would benefit from the issuance of an RAI that identifies the information needed for the staff to make it s safety finding.
- There also likely needs to be a bit of additional rigor when establishing by when the audit process for a particular chapter/LTR/etc. must close and any re maining unresolved issues be converted to formal RAIs. In some cases, the Project Managers, Technical Staff, and NuScale extended the audit phases for a particular C hapter/LTR/etc. and were successful in using the additional time to efficiently and effectively close the outstanding issues. However, in other cases, always with very g ood intentions, the extension of the audit phase out to a point close to when the S E input was due for a particular Chapter/LTR/etc. did not always leave an obvious win dow of opportunity to close the audit, issue an RAI, get a response, and complete the SE while staying on schedule.
- In some cases, technical branches expressed a reluctance to s tart documenting RAIs on a time frame which would have supported them being issued more promptly after the closure of the associated audit because they did not want to be seen as charging a few additional hours to the NuScale review to prepare just in case RAI questions if their last ditch attempts to resolve issues at the audit deadline failed. While their rigor with regard to managing hours charged may be appreciated, this may have bee n to the detriment of being able to keep the reviews moving by getting what turned ou t to be necessary RAIs issued more promptly.
The review charter specifies that the activities in Phase A inc lude the staff performing an audit and developing (1) items that could result as RAIs, and ( 2) an ASER without open items. While this change eliminated preparation of a safety eva luation with open items, the extensive use of audits has enabled the staff to identify issue s that previously would have been transmitted to the applicant as RAIs. The issues that are converted to RAIs out of the audit are, in effect, the remaining open items in the chapter.
As weve modified the review process, we may have lost some of the granularity of the former process with the DC review which had an earlier SE with open items phase which basically forced reviewers to get to that point in their writin g. There is some sense at least that for certain Chapter/LTR reviews, reviewers may not have cl early identified all their issues as early as they could have because they didnt write up their draft SE input early.
This observation is clouded somewhat by the specifics of the Nu Scale low/medium effort SDAA chapter reviews where reviewers were directed to use the S E that was already written for the corresponding DC chapter and only make minor modificati ons to address what changed (if anything) between the DC and SDAA.
Recommendations:
- 1. Management should convey that the use of audits is not inten ded to eliminate RAIs.
Rather, the purpose of the audit is to identify all the review issues and, when they cannot be resolved in the audit, are converted into RAIs that f ocus on obtaining information that the staff needs to make a safety finding.
- 2. Allow audit issues to be framed and sent as RAIs as soon as it has become clear that resolution via the audit is unlikely.
- 3. The audit for a particular Chapter or LTR should close 2.5 t o 3 months prior to the due date for the associated SE with all outstanding issues writ ten up and converted to RAIs within one week of the closure of the audit. Discretion should be allowed to extend the audit if the staff and PMs agree that the issue can be closed relatively quickly, even if it is discovered late in the audit.
- 4. The staff should strive to develop their draft safety evalua tion input for various chapter/LTR reviews significantly ahead of the schedule for the associated chapter ASER in order to better ensure that all potential issues are id entified early.
- 5. In order to further the efficient and effective issuance of RAIs needed to make a safety finding, NRLB PMs should review the management comments to draft RAIs during the prior round of RAIs to become aware of certain types or pattern of improvement needs and apply them during the PM review of draft RAIs. NRLB PMs should identify whether certain deficiencies (e.g., lack of tec hnical/guidance clarity, improperly cited regulations, etc.) indicate that more guidance /direction should be provided to reviewers to improve the initial quality of RAIs.