ML070520143

Lessons Learned - Accelerated Review Process ITS (DC Cook) Lessons Learned

ML070520143
Person / Time
Site:	Cook
Issue date:	03/05/2007
From:	NRC/NRR/ADRO/DIRS/ITSB
To:
Telson, R - NRR/DIRS - 415-2256
Shared Package
ML070520128	List: ML070520143
References
Download: ML070520143 (4)

Text

ACCELERATED REVIEW PROCESS ITS LESSONS LEARNED The following lessons learned from the Accelerated Review Process (ARP) address the internal operation of the ARP that involving the interactions between the Licensees review staff and the NRC review staff. For this purpose the ARP lessons learned are grouped as Ground Rules for conducting a TS Conversion Review. ITS Conversion Ground Rules need to be established to provide a baseline for efficient exchange of information between the NRC and Licensee and also to capture the lessons learned from previous efforts.

The following list of expectations/lessons learned should be considered when creating a working agreement between the NRC and the Licensee:

ITS Conversion Ground Rules

1. Review Times for RAIs- A reasonable time expectation for posting/answering/closing questions in the database should be agreed upon. This should include details associated with:

a. An acceptable response time by the licensee,

b. An acceptable response review time by the NRC,

c. The expectation on timely closure for those questions that are responded to satisfactorily,

d. For those questions that require additional information from the licensee, the expectation on review and response should also be considered,

e. Precedence- Past precedence/repeatability should be considered when establishing expectations on review times and effort.

f. Licensee should consider review and approval cycles and procedure requirements for final letter docketing.

The real issue on this is the compatibility between resources at NRC vs Licensee.

Specifically, the staff has the ability to generate RAIs at a higher rate than the licensee can respond. A consistent application of reviewer resources should translate into a consistent rate of RAI formation.

For those responses or closure resolutions that are taking too long, based on the previously agreed upon guidelines, an issue resolution panel should be engaged. The panel, consisting of NRR and Licensee personnel, should identify individual positions and provide solutions/success paths for RAI response delays. (Is a resolution panel needed, or simply to discuss the outliers in the weekly status meetings.)

2. BSI Definition- Changes which are in addition to the direct conversion of CTS to ITS have been labeled Beyond Scope Issues. The current guidance on defining a BSI can be found in NEI 96-06. It describes potential beyond scope or licensing basis changes as those that are both different than the CTS and different than the STS.

NEI 96-06 also provides guidance on the acceptability of including beyond scope issues

in the conversion. It supports that those changes which are in addition to the direct conversion of the CTS to the ITS but which may be included within the scope of an ITS conversion application include incorporation of Generic Letter line item improvements (including extending surveillance frequencies to 24 months in accordance with Generic Letter 91-04), incorporation of generically approved topical reports, i.e. AOT-STI, and generically approved risk based changes.

Changes which are considered beyond the scope of an ITS conversion application, and therefore may result in delays in the review and approval of the application, include plant-specific risk based changes, and power uprate.

It is appropriate for NRC STS Section reviewers to obtain additional help when required including concurrence from other NRR Sections and Branches, however, the responsibility for issue identification and closure should remain in the NRC assigned reviewer for the associated TS Section. Closure of BSIs is the responsibility of the Licensing PM. A mutual understanding, of the beyond scope concept, is required by both the Licensee and NRC to ensure the correct identification of beyond scope issues and the ultimate transfer of review responsibility for the issue in question to the NRC licensing PM for the facility conversion, with appropriate NRC technical support staff.

3. BSI Schedule Impact- When a licensee submits an ITS conversion that includes precedent setting BSIs or unapproved TSTFs, the licensee assumes they will be reviewed/approved within the schedule for the conversion. (Licensees never assume something would be approved without the proper review by the staff -

anything else would be pre-decisional) However, history has demonstrated that the review of those BSIs and TSTFs may potentially control the schedule.

Previously established conversion guidance permits only those BSIs that are not precedent setting and approved TSTFs to be incorporated into the conversion.

Therefore, during the acceptance review and/or initial public meeting, an effort should be made to identify any precedent setting changes incorporated in the proposed license amendment. The licensee will be given the option to retract the precedent setting BSIs or unapproved TSTFs or accept a separation between the BSI and the standard conversion. Each BSI element should receive individual schedule milestones that support the ITS conversion schedule milestones for completion. Precedent-setting BSIs, unapproved TSTFs and outstanding LARs subsequently identified during the staffs review would be subject to the same provision.

4. BSI Reviewers- A BSI review can be very complicated and time consuming. An NRC BSI Project Manager and BSI technical reviewers should be assigned and made part of the NRC review team during the initial public meeting. They should be trained with the team during the initial review and be informed of the precedent/non-precedent discussions. The BSI review and the conversion review need to track parallel paths for a timely completion for the entire license amendment review.

5. BSI Communication/Expectations- During the informal RAI process supporting BSI issues, the issue resolution process may stall due to poor communication/information exchange. As a result, the original issue is sometimes lost or misunderstood. It is important that the Q&A process maintains a keen focus on identified issues through out the issue resolution process.

6. BSI Reviewer Questions- Reviewers questions should fully describe the potential issues/concerns and stay within the scope of the conversion. Reviewers questions have sometimes tended to be very narrow in scope and have led to additional rounds of questions to fully address the potential issue/concern. In turn, this can cause a gradual loss of focus on the original issues/concerns, excessive to redundant review, and an inefficient use of staff and licensee resources and time.

Isnt the expectation that the RAI development takes place to alleviate documentation deficiencies as the reviewer prepares the draft SER. In other words, the RAI is needed to fill holes in the draft SER. In many cases the reviewers were asking questions without putting pen to paper on the draft SER.

A recommendation, especially for the less experienced reviewers, is that questions be screened by a more senior reviewer prior to being placed on the web page. Alternatively the appropriate NRC STS Section, the TS Section conversion lead or the licensing Project Manager could review each BSI-reviewer question before it is added to the question data base via the web page. This approach will help the NRC Project Manager and the TS Section conversion leads maintain the expected quality standards and awareness of issues as they develop. (Note this is the same expectation for a normal review).

7. More Restrictive Changes- Consistent application of requirements/justification to include more restrictive changes for an ITS Conversion is required. Inconsistent application of requirements to adopt more restrictive changes has been experienced in recent conversions. This inconsistency has resulted in an inefficient use of resources and tends to shift the focus from more important justifications to proposed changes that could very well be optional for the licensee.

8. Removal Of Brackets-NEI 01-03, Writers Guide for the Improved Technical Specifications, provides guidance for removal of bracketed items in the STS.

There has been an inconsistent level of detail required to justify the removal of brackets and the replacement of information inside the brackets. Licensee and NRC Project Management need to agree on specific acceptable criteria for bracket removal and information replacement.

9. Licensees should consider the level of detail for the JFDs to support a timely review. In past applications the JFD did not provide sufficient detail to fully explain the acceptability of the change/deviation.

10. The sufficiency review should develop a detailed schedule on the completion of the reviews on a sectional basis. This information can then be used by the Licensee for planning purposes. Consideration for alternate activities and vacation schedules should be included.

11. In all cases, the level of engineering detail that is provided with the application is a summary of the design documentation available on site. Consideration should be made to utilize the face-to-face meetings as a vehicle to review some of the onsite documentation. Requests for documentation can be made in an RAI and the Licensee can bring these to the meeting for reviews. This is similar to an inspection/audit. This would enable the staff to gain the comfort level that the backup documentation is sound and avoid unnecessary regulatory burden with docketing the information.

12. Face-to-face meeting minutes to be completed in a timely manner to capture participants and topic discussions.