ML20216D286
| ML20216D286 | |
| Person / Time | |
|---|---|
| Site: | Three Mile Island  |
| Issue date: | 03/11/1998 |
| From: | Colburn T NRC (Affiliation Not Assigned) |
| To: | Langenbach J GENERAL PUBLIC UTILITIES CORP. |
| References | |
| NUDOCS 9803160338 | |
| Download: ML20216D286 (2) | |
Text
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. March 11 1998
. Mr. James W. Langenbach, Vice President and Director- TMI-1 GPU Nuclear Corporation P.O. Box 480 Middletown; PA 17057
SUBJECT:
NRR AUDIT OF LICENSEE PROGRAMS FOR MANAGING COMMITMENTS ,
- MADE TO THE NRC
Dear Mr. Langenba.ch:
The NRC staff has initiated a variety of activities related to the management of licensing basis -
information as a result of problems encountered at the Millstone and Maine Yankee facilities. . As part of the staff's activities, audits of commitment management programs will be performed at eight representative reactor facilities. The audits will assess the licensees' implementation of commitments made to NRC and will also assess the long-term control of commitments as a follow-up to the issuance of industry guidance for evaluating and reporting changes to commitments made to the LRC. In this regard, Three Mile Island Unit No.1 (TMI-1) has been selected as one of eight facilities at which the staff will audit commitment management programs.
The audits will be performed by the WRR project manager ana will be performed using the
- enclosed guidance document, " Guidance for NRR Audit of Licensing Programs Managing Commitments Made to the NRC," a copy of which has already been provided to your staff.
Audits will take place during the next 90 days and will require approximately one week onsite.
Specifics details regarding dates and information to be provided in advance have been coordinated with your staff. The onsite portion of the TMI-1 audit is currently scheduled to begin March 30,1998. Following the completion of the audits, the staff will report the findings to the Commission a.:d, as necessary, make recommendations for changes to NRC policy or regulations regarding the handling of commitments made to the NRC that are not otherwise controlled by specific regulations.
Thank you for your cooperation in support of this effort. You, or your staff, may direct any questions regarding the audit to either myself (301) 415-1402 or William Reckley at (301) 415-1314.
Sincerely, Original signed by ,
l Timothy G. Colbum, Senior Project Manager 4 . Project Directorate 1-3 1
31gO O 89 Division of Reactor Projects - 1/ll 3 Office of Nuclear Reactor Regulation p PDR ,
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Docket No. 50-289
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J.Langenbach Three Mile Island Nuclear Station, Unit No.1 cc:
l Michael Ross Robert B. Borsum -
i Director, O&M, TMI B&W Nuclear Technologies GPU Nuclear Corporation Suits 525 l P.O. Box 480 1700 Rockville Pike Middletown, PA 17057 Rockville, MD 20852 l
John C. Fomicola William Domsife, Acting Director Director, Planning and Bureau of Radiation Protection Regulatory Affairs Pennsylvania Department of GPU Nuclear Corporation Environmental Resources
.100 Interpace Parkway P.O. Box 2063 Parsippany, NJ 07054 Harrisburg, PA 17120 l Jack S. Watmore Dr. Judith Johnsrud l- Manager, TM! Regulatory Affairs National Energy Committee GPU Nuclear Corporation Sierra Club P.O. Box 480 433 Orlando Avenue Middletown, PA 17057 State College, PA 16803 l Emest L. Blake, Jr., Esquire Peter W. Eselgroth, Region i Shaw, Pittman, Potts & Trowbridge U.S. Nuclear Regulatory Commission 2300 N Street, NW. 475 Allendale Road Washington, DC 20037 King of Prussia, PA 19406 Chairman Board of County Commissioners
- of Dauphin County Dauphin County Courthouse Harrisburg, PA 17120 Chairman Board of Supervisors of Londonderry Township
.R.D. #1, Geyers Church Road Middletown, PA 17057 Wayne L. Schmidt Senior Resident inspector (TMI-1)
U.S. Nuclear Regulatory Commission P.O. Box 311 Middletown, PA 17057 Regicnal Administrator Region i U.S. Nuclear Regulatory Commission 475 Allendale Road King of Prussia, PA 19406 I
GUIDANCE FOR NRR AUDIT OF LICENSEE PROGRAMS l FOR MANAGING COMMITMENTS MADE TO THE NRC i !
i 1.0 OBJECTIVES l l
The audits will assess the adequacy of licensees' implementation of a sample of commitments made to the NRC in past licensing actions (amendments, exemptions. ;
etc.) and licensing activities (bulletins, generic letters, etc.). The NRC staff i informed the Commission that such assessments would be conducted as a follow-up to the licensing basis issues identified at facilities such as Maine Yankee and Millstone.
The audits will also determine if licensees have implemented !
aapropriate controls for managing current and future commitments made to the NRC l t1at are not controlled by a codified regulatory process such as 10 CFR 50.59 or i 50.54, including notification of the NRC when changes- to commitments are determined to have safety or regulatory significance. The combined results of these audits and other NRC activities will help to determine if additional regulatory actions are needed in the area of commitment management.
2.0 BACKGROUND
l In the original Statements of Consideration for 10 CFR Part 54 " Requirements for !
Renewal of Operating Licenses for Nuclear Power Plants," dated December 13,1991 (56 FR 64943), the Commission explained in some detail the basis for its belief that the current regulatory process provides an acceptable level of safety. ;
Among other things, the Commission described a process whereby licensee-initiated !
changes to any particular plant's licensing basis are subject to the Commission's formal regulatory controls. This process ensures that a documented basis for licensee-initiated changes in the licensing basis exists and that NRC staff review and approval is obtained before implementation if the changes to the licensing basis raise an unreviewed safety question or involve changes to the technical specifications.
In SECY-92-314. " Current Licensing Basis for Operating Plants." dated September 10, 1992, the staff responded to the Commission's request to provide information and recommendations concerning compilation of the current licensing basis for operating reactors and current industry practices for updating the Final Safety Analysis Report (FSAR). In conducting the activities necessary to respond to the Commission, the staff noted that some licensee commitments are not contained in the plant's FSAR and. therefore, are not controlled by a defined regulatory process such as 10 CFR 50.59. As a result of the findings described in SECY 314, the staff proposed a series of actions to further examine the issues. The staff summarized these actions in SECY-94-066, " Evaluation of Issues Discussed in SECY-92-314, ' Current Licensing Basis for Operating Plants'."
Revision: 11/10/97 Audit Guide Enclosure 8 0115001 -
l .
l On January 4,1993, the ED0 established the Regulatory Review Group' (RRG) to identify those areas in which increased flexibility in the regulatory process l could be made available to licensees without adversely affecting the level of j i safety at operating plants. In SECY-94-003, " Plan for Implementing Regulatory l Review Group Recommendations." the staff informed the Comission of its )lan to implement recommendations made by the RRG. One of the areas identified in l
SECY-94-003 that would substantially reduce unnecessary regulatory burden was the development of guidance for use by licensees to control docketed commitments that are not contained in the FSAR. Two options were discussed in SECY-94-003 tc
, complete this RRG item: (1) to develop and promulgate staff guidance on what constitutes a " commitment" and the types of controls to be placed on changing
- commitments: or (2) to endorse a guideline develo As
! described below, the Nuclear Energy Institute (NEI)volunteered ped by the industry.
to develop a guideline for managing commitments.
In SECY-94-066, the staff submitted to the Comission the results of its further evaluation of the issues identified in SECY-92-314. To address the issues pertaining to commitments made to the NRC but not controlled by processes defined in regulations, the staff performed audits of licensee programs at Hope Creek.
l Crystal River. Fort Calhoun. Braidwood. Davis-Besse. Beaver Valley, and McGuire.
On the basis of the audit findings, the staff concluded that, in general.
l licensees had developed their own programs and processes that effectively managed comitments made to the NRC and controlled changes to these comitments. In its evaluation, the staff found that many licensees and NRC staff members did not have a clear understanding of when commitments can be changed without NRC interaction. This circumstance led most licensees to act conservatively, interacting with NRC staff, and reporting changes to commitments regardless of safety sienificance. This type of action resulted in an inefficient expenditure of both licensee and NRC resources. Therefore, in SECY-94-066 the staff referred to the recommendation of the RRG in SECY-94-003 to develop guidance, either by the staff or by the nuclear industry, on what constitutes a commitment and the types of controls to be placed on comitments.
The guidance developed by NEI on managing comitments provides a structured l
process, found acceptable to the staff in late 1995, that licensees can use on a voluntary basis. The NRC accepted version of the NEI document. " Guideline for i Managing NRC Comitments." Revision 2. dated December 19. 1995, is provided as an attachment to this audit guidance. The NEI guidance describes a process that can be used by licensees to modify or delete comitments and defines the circumstances in which interaction with the staff is appropriate.
l The NEI guidance document provides the following definitions to help clarify the
! regulatory significance of, and distinction between. an obligation and a regulatory comitment:
Obliaation means any condition or action that is a legally binding requirement
- imposed on licensees through applicable rules, regulations, orders, and j licenses (including technical specifications and license conditior.s). '
Audit Guide Revision: 11/10/97 i
r v I
' Reaulatory Comit=nt means an explicit statement to take a specific action agreed to or volunteered by a licensee that has been submitted in writing on the docket to the Commission.
In SECY-95-300. " Nuclear Energy Institute's Guidance Document. ' Guideline for Managing NRC Commitments'." dated December 20. 1995, the staff informed the Commission that the licensees' commitment change processes, either implementatim of the NEI guideline or licensee-specific programs, would be monitored to verify that commitments are being a)propriately controlled. If the audit process shows that licensees have not imp emented the NEI guidance, or have not adopted some equivalent level of control and documentation of changes to their commitments.
l the staff will reassess the need to promulgate staff guidance or initiate rulemaking. This reassessment will be initiated after the commitment control
- process at selected facilities has been audited using this guidance.
The NRC staff evaluated problems encountered with licensing basis issues at Millstone and Maine Yankee and offered lessons learned from these experiences in SECY-97-036. Millstone Lessons Learned Report. Part 2: Policy Issues." dated i
' February 12. 1997, and SECY-97-042. " Response to 0IG Event Inquiry 96-04S Regarding Maine Yankee." dated February 18.1997. Both reports recomended that, as part of an overall revision of its oversight of licensing basis information, the staff proceed with its plans to perform this audit to evaluate the industry's
< implementation of commitment management systems. As a result of the lessons learned from these efforts. it was deemed prudent to have the staff define a sample of previous commitments made to the NRC in licensing actions and licensing activities and to verify the licensees' implementation of those commitments.
This and other staff efforts related to managing licensee commitments made to the NRC are integral to improving the staff's performance in (1) identifying important l'censee commitments or other supporting design features or operating practices used by the licensee to justify a proposed change or address design or operational problems. (2) determining by what means im)ortant commitments or other supporting information should be verified, and (3) determining the appropriate placement of the information within the various licensing basis documents associated with the affected facility (i.e. the license or technical specifications, the FSAR. program description documents, or docketed correspondence without formal regulatory controls). NRR process changes are being made to address these concerns for future activities. The part of this audit that looks at licensee implementation of past commitments will be included, along with reviews of past audit and inspection findings. in an assessment of the need for additional staff actions. This assessment will include. to the extend practical, a review of the findings from those inspections performed in accordance with temporary instructions associated with licensing activities such as bulletins and generic letters. Additional staff actions following the assessment may include additional NRC inspections, requests for information from licensees or proposing changes to NRC regulations.
Revision: 11/10/97 Audit Guide
3.0 AUDIT GUIDELINES 3.1 VERIFICATION OF LICENSEE IMPLEMENTATION OF PAST COMMITMENTS The primary focus of this part of the audit is to confirm that licensees have implemented those comitments made to the NRC as part of past licensing actions and resolution of past licensing activities. The audit should ensure that the sample of past comitments were implemented in a manner that satisfied both the action comitted to and the overall intent of the comitment. The auditor should .
select a sample of approximately 15 individual and unrelated comitments that I were included in licensee correspondence in order to justify a licensing action (amendment, exemption, etc.) or resolve a licensing activity (bulletin, generic !
1 letter, etc.). The sample should be selected following informal discussions with appropriate regional staff, review of licensee tracking data, review of any reports submitted by the licensee, and consideration of other information or concerns of individual auditors. l 3.2 LICENSEE PROGRAMS FOR MANAGING COMMITMENTS MADE TO THE NRC The primary focus of this part of the audit is the licensee's performance related to implementing controls for modifying or deleting comitments made to the NRC. !
The audit should ensure that changes to comitments (modifications or deletions) are evaluated in accordance with the licensee's programs and procedures, the licensee's technical evaluations adequately justify the change, and that the NRC l 1s informed of comitment changes that have safety or regulatory significance.
The auditor should, as a minimum, determine whether the licensee, using the NEI guidelines or alternative process, resolved safety issues pertinent to the associated comitment and has or will inform the NRC of the change if the applicable notification threshold is exceeded.
1 3.2.1 Procedures and Controls
- a. Verify that the licensee has established administrative controls for modifying or deleting commitments made to the NRC. The controls for changing comitments made to the NRC may be included in a stand-alone comitment management system or may be incorporated into other licensee administrative programs.
- b. Verify that the programs provide guidance regarding the evaluation of proposed changes to comitments in terms of safety and regulatory significance. The licensee's guidance should likewise include criteria for determining when it would be appropriate to notify the NRC of a comitment change. The NEI guidance document is an acceptable guide for licensees to follow for managing and changing their comitments to the .
NRC. For those licensees that have not adopted the NEI methodology, document a comparison of the licensee's process, including criteria for evaluation of changes and NRC notification, to that recomended in the l NEI guideline.
Audit Guide Revision: 11/10/97 L
! 3.2.2 Imolementation
- a. Commitment Chanaes Reoorted to NRC. Select an appropriate sample of l commitment changes (modifications or deletions) that were reported or l will be reported to the NRC. Ten or more examples should be used if the licensee has performed many evaluations since the last major revision of l its commitment change process: otherwise include as many examples as practical to assess the licensee's program for controlling commitment I changes. Each commitment will be reviewed to determine the adequacy of the licensee's technical justification for the change in commitment. The sample should be selected following informal discussions with appropriate ,
regional staff, review of licensee tracking data, review of any reports j submitted by the licensee, and consideration of other information or l
l concerns of individual auditors. Try to select commitment changes from !
as many of the following categories as practical: j
- 1. Generic Letter Responses:
)
- 2. Bulletin Responses:
- 3. Licensing Actions (amendments, reliefs, or exemptions): or
- 4. Responses to Notices of Violation (NOVs): l l
S. Licensee Event Reports (LERs):
- 6. Inspection Reports: i
- 7. Other docketed correspondence.
- b. Commitment Chances Not Reoorted to NRC. Select examples of commitment -
changes (modifications or deletions) that the licensee has not and does l not )lan to report to the NRC. Approximately 10 commitment changes '
shou'd be selected using the various categories and considerations discussed above. Each selected commitment change will be reviewed to l determine the adequacy of the licensee's technical justification for the l change as well as the determination that notification of the NRC was not l warranted. The sample should be selected following informal discussions l
with appropriate regional staff, review of licensee tracking data, and consideration of other information or concerns of individual auditors.
- c. Notifications to the NRC. For those commitment changes that are determined to warrant NRC notification, confirm that the notification has or is planned to be made and that the notification accurately describes the change,
- d. Traceability of Commitments. Confirm that the licensee has implemented a process to ensure the traceability of commitments to support the change control process. Such processes should ensure that licensee personnel are able to identify when their activity may involve changing a Revision: 11/10/97 Audit Guide l
regulatory commitment and direct them to the commitment management process. Select a sample of recently implemented comitments and evaluate whether the licensee's process would reasonably support identification of the comitment in case personnel subsequently propose to alter the design features or operating practices that were the subject of the comitments. The sample should be selected following informal discussions with appropriate regional staff, review of licensee tracking i
data, review of any reports submitted by the licensee, and consideration of other information or concerns of individual auditors. Note that the NEI guide does not provide recommendations for performing this function.
4.0 GUIDANCE Regulatory comitments are specific actions that have been agreed to or j volunteered by a licensee and are documented in docketed correspondence. Unlike {
regulatory requirements (obligations) contained in regulations, licenses, and '
orders, regulatory commitments are not legally-binding. However, the regulatory process appro)riately relies on comitments in many instances and the NRC expects licensees to lonor. in good faith, commitments that have a safety or regulatory 4 purpose. In large measure. regulatory commitments are not contained in the FSAR.
but in other docketed correspondence such as licensee event reports. responses to Notices of Violation, responses to generic letters. applications for licensing actions, and responses to requests for additional information. Those commitments not contained in the FSAR may not be controlled by a defined regulatory process such as 10 CFR 50.59. Therefore, licensees may have the ability to change docketed commitments not contained in the FSAR without informing the Comission.
The NRC staff has the ability to issue an enforcement action if the failure to l implement a commitment has the potential to adversely affect reactor safety. The l staff may also use the administrative enforcement tool of a Notice of Deviation if a licensee fails to satisfy a commitment. In addition, issues regarding completeness and accuracy of information submitted to the NRC may warrant consideration of the requirements of 10 CFR 50.9. Additional measures are being implemented to ensure that licensee commitments and other important information l regarding plant design and operating practices are placed into the most appropriate licensing basis document, whether that be the license. FSAR or docketed correspondence.
Although a specific action committed to by a licensee may not be legally-binding.
the auditors should carefully consider whether the comitment, or an alternative '
action is necessary to ensure compliance with an NRC regulation or otherwise ensure safe plant operation. For example, a licensee's response to a generic letter may comit to perform routine surveillances or tests beyond those contained in a plant's technical specifications in order to ensure the operability of an important system or component. The licensee's failure to implement such a comitment or failure to adequately evaluate changes to that comitment may call into question the operability of the related system or component. Safety concerns or possible regulatory nonconformances that are discovered during this audit should be forwarded to the appropriate regional personnel for follow-up as part of the NRC's inspection program.
Audit Guide Revision: 11/10/97 m
1 4.1 VERIFICATION OF LICENSEE IMPLEMENTATION OF PAST COMMITMENTS In defining the audit sample of approximately 15 commitments from past licensing actions and licensing activities, the auditors should consider the following in selecting commitment cbsages for review:
- 1. G oose commitments related to a variety of systems:
- 2. Choose comitments involving a variety of engineering disciplines, such as nuclear, mechanical, civil, and electrical:
- 3. Choose commitments that involve a variety of licensee actions such as design modifications, temporary modifications, procedure revisions, personnel training, and revised administrative controls:
- 4. Ensure that the sample of selected commitments includes some which were important to the NRC staff's decision-making 3rocess for licensing actions and licensing activities during the 'ast several years.
To the extent practical, identify comitments for verification that have not been previously addressed by NRC i mections or audits. It is desirable to choose commitments with a prefen m m risk significant issues or systems. In addition, the auditor si- 1 ct; 7t to verify that not only the stated commitments have been ss ~'J . l that the underlying intents of the comitments have been ' ' # For example, in contrast to verifying the installation of major equi) ment or issuance of major procedure or program documents, the, audit. aboulc assess the lower profile but essential aspects of implementation such as the commitments regarding maintenance or surveillance of the subject e the subject process changes.quiament The comitment and training or effectiveness or aspect measures of a comitment being for verified and the information needed to perform the verification should, as much as possible, be identified and comunicated to the licensee prior to the site visit in order to minimize time spent waiting for information. The auditor should have informal discussions with the regional staff and other NRC staff with potential insights pertaining to a licensee's performance in the area of c implementing commitments in preparation for the audit.
To verify the implementation of specific commitments, review licensee commitment management reccrds, work orders, revised procedures, NRC inspection reports, and other documentation that could demonstrate that the specific actions were completed in accordance with the stated comitment and related schedule.
Discussions with licensee personnel in licensing, system engineering, and other organizations may be useful in placing the comitnent and its implementation in the app opriate historical and technical context. Where appropriate, utilize ar:tual hysical verifications of affected equipment or procedures. The auditor should etermine the needed level of investigation to verify the implementation of each selected comitment. Whereas some comitments may be verified by a simple review of a revised procedure, training record, or completed work order, Revision: 11/10/97 Audit Guide 1
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verification of other commitments may require more exhaustive reviews of design !
documents and surveillance histories, comparison of corrective actions to '
appropriate effectiveness measures, or interviews with licensee personnel.
4 ,
l For eachinselected resulted an updatecommitment, determine to the facility's updateif t#m[lementation of the final safety analysis commitment report (UFSAR). additional docketed correspondence (e.g., a letter confirming implementation) or other communications with the NRC staff. The auditor should also determine if the comitment should have been captured in an update of the UFSAR. Concerns regarding a potential violation of 10 CFR 50.71(e) identified during this audit should be referred to the appropriate regional office for follow-up or otherwise pursued using other inspection and enforcement guidance. i 4.2 LICENSEE PROGRAMS FOR MANAGING COMMITMENTS MADE TO THE NRC This guidance is intended to help auditors in evaluating licensee programs related to the revision of comitments made to the NRC. The audit consists of !
two parts: (1) procedures and controls; and (2) implementation. Reviewing the l licensee's comitment management program procedures in the office will allow more '
time for implementation review while onsite. Choose the initial selection of comitment changes in the office using licensee-supplied lists of proposed and completed commitment changes and any available independent knowledge of recent changes to previous comitments or activities that would likely affect past comitments. In addition, select recent commitments from docketed corresponcen for performing the part of the audit dealing with traceability. At least one week before the audit. inform the licensee which comitment changes have been selected for possible review.
This should minimize the time waiting for the licensee to produce the requested documentation.
NEI's guidarce document is an acceptable guide for licensees to follow for managing and changing their comitments to the NRC. The defined process and controls of the NEI guidance document are the preferred method, but auditors may encounter various degrees of formality and involvement of NRC staff in licensee processes for changing commitments. Various inspection and NRR activities include or will include, verification that commitments agreed to or volunteerei by the licensee have been implemented in accordance with the original licensee comitment and related schedule. This part of the audit focuses on subsequent danges to licensee commitments that may or may not involve interactions with the NRC. The aJdit should (1) evaluate the licensee's method for evaluating ?roposed changes to regulatory comitments with consideration given to the inten; of the original commitment and the safety and regulatory significance of the proposed change, and (2) evaluate the licensee's method for communicating comitment changes to the NRC when such changes are deemed significant to safety or the NRC's regulatory function.
An important aspect of comitment management that is not addressed in the NEI guideline is the part of the process that ensures traceability of comitments.
The NEI guideline provides a basic framework for evaluating a change to a comitment once licensee personnel propose such a change. However, for those
( personnel to utilize the NEI guideline. they must realize when a change to a Audit Guide Revision: 11/10/97 u
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plant design feature or-operating practice affects a commitment made to the NRC staff. For example, a licensee commits to perform independent verification at a specific point in the execution of a procedure as a result of problems identified in an NRC Notice of Violation. Several years later, the licensee determines that the independent verification step is no longer necessary due to improved performance of its personnel. In order for a commitment change process to work effectively, the personnel likely to propose a revision to the affected procedure must be able to identify that the independent verification was added to the procedure as part of a regulatory comitment. Possible ways to provide traceability include markings or notations within the procedure and administrative requirements to investigate proposed procedure changes that might affect regulatory comitments. Similar processes would be necessary for design features or other licensee comitments not incorporated into controlled procedures.
4.2.1 Procedures and Controls
- a. Verify that the licensee has defined a process for managing comitments made to the NRC. Sucn process descriptions may be contained in licensee procedures, general guidance documents, program descriptions, training material. administrative documents, or combinations of these documents.
The controls for changing comitments made to the NRC may be included in a stand-alone comitment management system or may be incorporated into other licensee corrective action, licensing or administrative programs.
Comitment management systems may involve periodic assessments of all outstanding comitments or may evaluate changes on a case-by-case basis.
Indentify the governing procedures and guidance documents and discuss ..e licensee's comitment change process with the responsible licensee personnel. Document how the licensee's process is controlled as well as the how the process is used to evaluate proposed changes to comitments.
For example the process may be governed by an administrative procedure or other document that is controlled in accordance with facility technical specifications and quality assurance programs or the process may be controlled within a licensing group as a relatively informal procedure. In either case, the effectiveness of a licensee program will consider the assessments performed for Item 3.2.2. Implementation, of this audit.
- b. Verify that licensee programs include guidance regarding the evaluation of pro)osed changes to commitments in terms of safety and regulatory signif cance. The comitment change process should distinguish between the changes licensees can implement without interaction with the NRC and those governed by regulations that may require NRC review and approval prior to implementation. The process should include a mechanism for determining when it would be appropriate to notify the NRC of a comitment change. The NEI guidance document is an acceptable guide for licensees to follow for managing and changing their comitments to the NRC. Ensure that the licensee has integrated the commitment management system with other line organization functions to ensure traceability of Revision: 11/10/97 Audit Guide
l l a regulatory commitment following its initial implementation. Such systems are necessary to ensure that licensee personnel are able to recognize that future changes to the affected design features or
' operating practices require evaluation of the proposed change in accordance with the commitment chan
- design or procedure change process. ge process as well as the normal Although the process and review criteria in the NEI guidance document is the preferred method for controlling changes to commitments, there is no defined regulatory recuirement that specifies how licensees must control those changes. Tierefore. licensees may define criteria for justification of commitment changes and NRC notification of such changes that are different than those recommended in the NEI guidance. For those licensees that have not adopted the NEI methodology, document a comparison of the licensee's process, including criteria for evaluation of changes and NRC notification, to that recommended in the NEI guide.
Although observations regarding the licensee's process or related criteria should be included in the documentation of the audit, any concerns related to the actual effectiveness of licensee programs should be reinforced by actual examples reviewed in accordance with Item 4.2.2.
~
Implementation, of this audit guidance.
4.2.2 Imolementation The implementation area of the audit assesses the licensee's performance implementing its commitment change proass. Commitments and changes thereto can involve all technical disciplines associated with a nuclear plant. Few auditors are expert in every nuclear-related discipline. Therefore, the auditor should recognize when technical assistance is needed to effectively review a safety evaluation or resolve a safety concern. The need for assistance can be antici ted based on the commitment changes selected for review. Also acceptable is si ly identifying and documenting (in the documentation of the audit) techni 1 questions for follow-up at a later date (either by the region or NRR).
Recognizing failures of the licensee to comply with the administrative control requirements of its commitment change process is important. However, recognizing failures of the licensee to adequately assess how a change will affect plant operational safety or compliance with applicable regulations is more important.
The focus of the implementation part of the audit should, therefore, be on safety and ensuring that revised commitments have not led to noncompliance with applicable regulations. For example, if you agree that a commitment change was safe and believe it would not introduce issues of compliance with any regulations, questions or concerns regarding the change process can simply be documented in the audit report. By contrast, a commitment change evaluation that failed to address an obvious safety or regulatory consideration would be more significant. Failure to recognize that a commitment change required assessment by regulations such as 10 CFR 50.59 or 50.54 may also be significant. Safety l concerns or possible regulatory nonconformances that are discovered during this i audit should be forwarded to the appro part of the NRC's inspection program.priate regional personnel for follow-up as Audit Guide Revision: 11/10/97
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