ML20217N573
| ML20217N573 | |
| Person / Time | |
|---|---|
| Site: | FitzPatrick  |
| Issue date: | 04/30/1998 |
| From: | Williams J NRC (Affiliation Not Assigned) |
| To: | James Knubel POWER AUTHORITY OF THE STATE OF NEW YORK (NEW YORK |
| References | |
| NUDOCS 9805050375 | |
| Download: ML20217N573 (19) | |
Text
3s April 30, 1998 Mr. J1mes Knubel Chief Nuclear Officer Power Authority of the State of
- New York 123 Main Street -
White Plains, NY 10601
SUBJECT:
NRR AUDIT OF LICENSEE PROGRAMS FOR MANAGING COMMITMENTS MADE TO THE NRC
Dear Mr. Knubel:
The NRC staff has initiated a variety of activities related to the management of licensing basis information as a result of problems sncountered at the Millstone and Maine Yankee facilities. As part of the staff's activities, audits of comm'iment 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 NRC. In this regard, the James A. FitzPatrick Nuclear Power Plant has been selected as one of reight facilities where the staff will audit commitment management programs.
The audits will be performed by the NRR project' manager and will be performed using the enclosed guidance document," Guidance for NRR Audit of Licensing Programs Managing Commitments Made to the NRC." The audit is currently planned to be performed during the week of May 11 - 15,1998. Specific details regarding information to be provided in advance will be coordinated with your staff. Following the completion of the audits, the staff will report the findings to the Commission and, 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. If you halve questions on this topic, please call me at (301) 415-1470, or William Reckley at (301) 415-1314.
Sincerely,
' Joseph IN rhecth5 nager Project Directorate 1-1 Division of Reactor Projects - 1/11 Office of Nuclear Reactor Regulation
' Docket No. 50-333 '
Enclosure:
As stated -
cc w/ encl: See next page
^
DISTRIBiJTION:
Dosisat181e' J. Zwolinski (A) - S. Little -- W. Reckley ACRS \\
PUBLIC ' S. Bajwa. ;J. Williams OGC C.Hehl PDI-1 R/F gg
- DOCUMENT NAME: G:\FITZ\ COMMIT.LTR ,
To receive a copy of this document, indicate in the box: "C" = Copy without attachment / enclosure E"
- = Copy with attschment/ enclosure ."N" = No copy .
OFFICE PM:P0l*1 //84/ lE LA: POI 1. L M- l D:PDI 1 A l l l NAME WiTETHE /fdN.4terni SLtttle V $5aJwe N8 %
DATE 04/ % /98 04/ d /96 04/tB/98 04/ /98 04/ /98 Official Record Copy 9905050375 990430 @
}- gor Apocnosoogs I[ - d i { p .$ $ $ p fa e rg y
1
. April 30, 1998
.: 6. .
- Mr. Jdmes Knubel IV- ~
Chief Nuclear Officer Power Authority of the State of.
New York 123 Main Street White Plains, NY 10601
SUBJECT:
NRR AUDIT OF LICENSEE PROGRAMS FOR MANAGING COMMITMENTS MADE
, TO THE NRC
Dear Mr. Knubel:
l l
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 commitmord 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 NRC. In this regard, the James A. FitzPatrick Nuclear Power Plant ,
has been selected as one of eight facilities where the staff will audit commitment management j programs. !
(
The audits will be performed by the NRR project manager and will be performed using the I enclosed guidance document, " Guidance for NRR Audit of Licensing Programs Managing .
Commitments Made to the NRC." The audit is currently planned to be performed during the -
week of May 11 - 15,1998. Specific details regarding information to be provided in advance will
. be coordinated with your staff. Following the completion of the audits, the staff will report the -
findings to the Commission and, as necessary, make recommendations for changas 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. If you have questions on this topic, please call me at (301) 4151470, or William Reckley at (301) 415-1314.
Sincerely,'
Joseph ibs rkectN5 nager Project Directorate 1 Division of Reactor Projects - 1/11 Office of Nuclear Reactor Regulation Docket No. 50-333
Enclosure:
As stated cc w/ encl: See next page DISTRIBUTION:
Docket File - J. Zwolinski (A) S. Little W. Reckley ACRS PUBLIC S. Bajwa J. Williams OGC C.Hehl PDl-1 R/F
' DOCUMENT NAME: G:\FITZ\ COMMIT.LTR To receive a copy of this document, indicate in the box: "C" = Copy without attachment / enclosure "E"
= Copy with attachment / enclosure "N" = No copy 0FFICE PM:PDI-1. / M lE LA:PDI*1 1 M - l D: POI 1 g l l l NAME 1retstTFiB /faALLterM SLittie V $8eJwe #' %
DATE 04/.27/98 04/ 3 /98 04/ tB/98 04/ /98 04/ /98 Official Record Copy
S
[ UNITED STATES
,j NUCLEAR REGULATORY COMMISSION
& WASHINGTON, D.C. 30666 0001
%..... April 30.1998 Mr. James Knubel Chief Nuclear Officer Power Authority of the State of New Yost 123 Main Street
- White Plains, NY 10601 -
SUBJFCT: NRR AUDIT OF LICENSEE PROGRAMS FOR MANAGING COMMITMENTS MADE -
TO THE NRC
Dear Mr. Knubel:
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 NRC. In this regard, the James A. FitzPatrick Nuclear Power Plant has been selected as one of eight facilities where the staff will audit commitment management programs.
. The audits will be performed by the NRR project manager and will be performed using the enclosed guidance document, " Guidance for NRR Audit of Licensing Programs Managing Commitments Made to the NRC." The audit is currently planned to be performed during the week of May 11 - 15,1998. Specific details regarding information to be provided in advance will be coordinated with your staff. Following the completion of the audits, the staff will report the findings to the Commission and, 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. If you have questions on this topic, please call me at (301) 415-1470, or Wdliam Reckley at (301) 415-1314.
Sincerely, ,
. An Jos ph F. Williams, Project Manager Project Directorate I-1 Division of Reactor Projects -1/11 Office of Nuclear Reactor Regulation Docket No. 50-333
Enclosure:
As stated cc w/ encl: See next page
James Knubel James A. FitzPatrick Nuclear Power Authority of the State Power Plant of New York cc:
Mr. Gerald C. Goldstein Regional Administrator, Region i Assistant General Counsel U.S. Nuclear Regulatory Commission Power Authority of the State 475 Allendale Road of New York King of Prussia, PA 19406 -
l- 1633 Broadway
- l. New York, NY.10019 Mr. F. William Valentino, President i L
New York State Energy, Research, , i Resident inspector's Office and Development Authority U. S. Nuclear Regulatory Commission Corporate Plaza West j P.O. Box 136 286 Washington Avenue Extension i Lycoming, NY 13093 Albt ny, NY 12203-6399 ;
Mr. Harry P. Salmon, Jr., V.P. Mr. lichard L. Patch, Director Nuclear Operations QLality Assurance Power Authority of the State Power Authority of the State I of New York of New York 123 Main Street 123 Main Street
. White Plains, NY 10601 White Plains, NY 10601 i
Ms. Charlene D. Faison Mr. Gerard Goering i Director Nuclear Licensing 28112 Bayview Drive !
Power Authority of the State Red Wing, MN 55066 i of New York 123 Main Street Mr. James Gagliardo White Plains, NY 10601 Safety Review Committee 708 Castlewood Avenue Supervisor Arlington,TX 76012 Town of Scriba Route 8, Box 382 Mr. Arthur Zaremba, Licensing Manager Oswego, NY 13126 James A. FitzPatrick Nuclear Power Plant Mr. Eugene W. Zeitmann P.O. Box 41 President and Chief Oporating Lycoming, NY 13093 Officer Power Authority of the State Mr. Paul Eddy of New York New York State Dept. of 123 Main Street Public Service White Plains, NY 10601 3 Empire State Plaza,10th Floor Albany, NY 12223 Charles Donaldson, Esquire Assistant Attomey General New York Department of Law 120 Broadway New York, NY 10271
.. ., 1 GUIDANCE FOR NRR AUDIT OF LICENSEE PROGRAMS FOR MANAGING COMMITMENTS MADE TO THE NRC 1.0 OBJECTIVES The audits will assess the adequacy of licensees' implementation of a sample of comitments made to the NRC in past licensing actions (amendments, exemptions.
etc.) and licensing activities (bulletins, generic letters, etc.). The NRC staff informed the Comission 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 a)propriate controls for managing current and future comitments made to the NRC tlat are not controllt;d by a codified regulatory process such as 10 CFR 50.59 or 50.54, including notification of the NRC when changes to comitments 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 comitment management.
2.0 BACKGROUND
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 Comission explained in some detail the basis for its belief that the current regulatory process provides an acceptable level of safety.
Among other things, the Comission described a process whereby licensee-initiated changes to any particular plant's licensing basis are subject to the Comission'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 Comission's request to provide informaticn and recomendations 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 Comission, the staff noted that some licensee comitments 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 sumarized 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
On January 4.1993, the.EDO esti.'lished the Regulatory Review Group (RRG) to identify those areas in which inu eased flexibility in the regulatory process could be made available to licensees without adversely affecting the level of safety at operating plants. In SECY-94-003. " Plan for Implementing Regulatory Review Group Recommendations." the staff informed the Comission of its )lan to implement recommendations made by the RRG. One of the ' areas identified in
. SECY-94-003 that would substantial ly 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 to complete this RRG item: (1) to develop and promulgate staff guidance on what constitutes a " commitment" and the types of contro's to be placed on changing -
commitments: or (2) to endorse a guideline developed by the industry. As described below, the Nuclear Energy Institute (NEI) volunteered to develop a guideline for managing commitments.- '< =
In SECY-94-066, the staff submitted to the Commission 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.
Crystal River. Fort Calhoun. Braidwood. Davis-Besse. Beaver Valley, and McGuire. ;
On the basis of the audit findings, the staff concluded that, in general, licensees had developed their own programs and processes that effectively managed commitments made to the NRC and controlled changes to these commitments. In its evaluation, the staff found that many licensees and NRC staff members did not have a clea'r understandits 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 significance. This t of both licensee and NRC' ype of action resulted in an inefficient expenditure 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' commitments.
The guidance developed by NEI on managing commitments provides a structured 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 '
Managing NRC Commitments." 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 commitments and defines the circumstances in which interaction with the staff is appropriate.
The NEI guidance document provides the following definitions to help clarify the regulatory significance of and distinction between, an obligation and a regulatory commitment: 1 Obligation means any condition or action that is a legally binding requirement imposed on licensees through applicable rules, regulations, orders, and licenses (including technical specifications and license conditions).
Audit Guide Revision: 11/10/97 l
1 Regulatory Commitment means an explicit statement to take a specific action a reed to or volunteered by a licensee that has been submitted in writing on
.t docket to the Commission.
In SECY-95-300 " Nuclear Energy Institute's Guidance Document 7 Guideline for Managing NRC Commitments' " cated December 20, 1995, the staff informed the Commission that the licensees' commitment change processes, either implementatici of the NEI guideline or licensee-specific programs, would be monitored to verify that comitments are being a)propriately controlled. If the audit process shows that licensees have not imp emented the NEI guidance, or have not adopted some I equivalent level of control and documentation of changes to their commitments, the staff will reassess the need to promulgate staff guidance or initiate rulemaking. This reassessment will be initiated after the commitment control i
process.at. selected. facilities has been audited using this guidance. -
l l The NRC staff evaluated problems encountered with licensing basis issues at !
- Millstone and Maine Yankee and offered lessons learned from these experiences in i SECY-97-036, " Millstone Lessons Learned Report, Part 2
- Policy Issues," dated l . February 12, 1997, and SECY-97-042, " Response to 0IG Event Inquiry 96-04S )
, Regarding Maine Yankee," dated February 18, 3997. Both reports recommended that, !
l as part of an overall revision of its oversight of licensing basis information, '
l 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 l important licensee commitments or other supporting design features or operating practices used by the licensee to justify a proposed change or address design or -l l operational problems, (2) determining by what means im>ortant commitments or ;
other supporting information should be verified, anc (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 L correspondence without formal regulatory controls). NRR process changes are being made to address these concerns for future activities. The part of this i audit that looks at licensee implementation of past commitments will be included, l
' 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 j L licensees, or proposing changes to NRC regulations. ;
l !
Revision: 11/10/97 Audit Guide
~
3.0 AUDIT GUIDELINES 3.1 VERIFICATION OF LICENSEE IMPLEMENTATION OF PAST COMITMENTS The primary focus of this part of the audit is to confirm that licensees have
-implemented those commitments 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 commitments were implemented in a manner that satisfied both the action committed to and the overall intent of the commitment. The auditor should
. select a sample of approximately 15 individual and unrelated commitments that s 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.
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 implementin The audit shou'g controlsthat d ensure for changes modifyingtoor deleting comitments commitments madeortodeletions)
(modifications the NRC.
are evaluated in accordance with the licensee's programs and procedures, the licensee's technical evaluations adequately justify the change, and that the NRC is informed of commitment 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.
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 commitments made to the NRC may be included in a stand-alone commitment management system or may be incorporated into other licensee administrative programs.
- b. Verify that the programs prov1de guidance regarding the evaluation of proposed changes to commitments in terms of safety and regulatory significance. The licensee's guidance should likewise include criteria "or determining when it would be appropriate to notify the NRC of a ctmmitment 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 recommended in the NEI guideline.
Audit Guide Revision: 11/10/97
.c 3.2.2 Imolementation' l 1
- a. Commitmant Chanoes Reoorted to NRC. Select an ' appropriate sample ofi l commitment changes .(modifications or deletions) that were reported or
.will be reportec to the NRC. Ten or more examples should be used if the licensee has performed many evaluations since the last major revision of.-
its commitment change process:- otherwise, include as many examples as practical to assess the -licensee's program for controlling commitment changes. Each commitment will be reviewed to determine the adequacy of
~ the licensee's technical justification for the change in commitment. The i sample should be selected following informal discussions with appropriate i regional staff, review of licensee tracking data, review of any reports j submitted by the licensee. and consideration of other information or concerns of individual' auditors Try to' select commitment changes from as many of the following categories as practical:
- 1. Generic Letter Responses:
- 2. Bulletin Responses:
- 3. Licensing Actions-(amendments, reliefs, or exemptions); or
- 4. Responses to Notices of Violation (NOVs):
- 5. Licensee Event Reports (LERs):
- 6. Inspection Reports: a
- 7. .Other docketed correspondence.- i
- b. Commitment Chanaes Not Reoorted to NRC. Select examples of commitment ,
changes (modifications or deletions) that the licensee has not and does
~
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 determine the adequacy of the licensee's technical justification for the change as well as the determination that notification of the NRC was not warranted. The sample should be selected following informal discussions with approoriate regional staff, review of licensee tracking data, and .j 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 J the change.
'd. Jraceab111tvofCnmmitmants. Confirm that the licensee has implemented l 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
regulatory commitment and direct them to the comitment 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 commitments. 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. 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 volunteered by a licensee and are documented in docketed correspondence. Unlike regulatory requirements (obligations) contained in regulations, licenses, and orders, regulatory comitments are not legally-binding. However, the regulatory process approariately relies on comitments in many instances and the NRC expects licensees to 1onor, in good faith, commitments that have a safety or regulatory aurpose. In large measure, regulatory comitments are not contained in the FSAR,
)ut in other docketed correspondence such as licensee event reports, responses to Notices of Violation, responses to generic letters, application , for licensing actions, and responses to requests for additional information. Those comitments 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 c' 'tments not contained in the FSAR without informing the Commission.
The NRC staff has the ability to issue an enforcement action if the failure to implement a comitment has the potential to adversely affect reactor safety. The 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 regarding plant design and operating practices are placed into the most appropriate licensing basis document, whether that be the license, FSAR, or docketed correspondence, i
Although a specific action comitted 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 commit to contained in a plant' perform routine s technical surveillances specifications in or teststobeyond order ensurethose 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 I personnel for follow-up as part of the NRC's inspection program.
Audit Guide Revision: 11/10/97
)
l
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4.1 VERIFICATION OF LICENSEE IMPLEMENTATION OF PAST COMMITMENTS 1 l
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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 changes for review:
- 1. Choose comitments related to a variety of systems:
- 2. Choose commitments involving a variety of engineering disciplines, such as nuclear, mechanical, civil, and electrical:
- 3. Choose commitments that involve a variety of lictasee 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. I To the e < tent practi' 51, identify commitments for verification that have not been '
previously addresse' by NRC inspections or audits. It is desirable to choose commitments with 3 reference to risk significant issues or systems. In
' addition, the audi. Jr should attempt to verify that not only the stated commitments have been satisfied but that the underlying intents of the l commitments have been fulfilled. For example, in contrast to verifying the installation of major pieces of equi) ment or issuance of major procedure or program documents, the auditor shoulc 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.quipment and training The commitment or of or aspect effectiveness measures a commitment being for verified and the information needed to perform the verification should, as much as possible, be identified and communicated 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 l potential insights pertaining to a licensee's performance in the area of I implementing commitments in preparation for the audit.
l- To verify the implementation of s ,
management records, work orders, pecific revised commitments, procedures. review licensee NRC inspection reports, commitment and !
other documentation that could demonstrate that the specific actions. were !
completed in ace.;rdance with the stated commitment and related schedule. .
Discussions with licensee personnel in licensing, system engineering, and other organizations may be useful in placing the commitment and its implementation in )
1
- the ap riate historic 61 and technical context. Where appropriate, utilize actual sical verifications of affected equipment or procedures. The auditor should ermine the needed level of investigation to verify the implementation of each selected comitment. -Whereas some commitments may be verified by a simple review of a revised procedure, training record, or completed work order, Revision
- 11/10/97 Audit Guide I
I
T l 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.
L . For each selected commitment, determine if the implementation of the commitment resulted in an update to the facility's updated final safety analysis 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 commitment should have been captured in an update of the L UFSAR. . Concerns regarding a potential violation of 10 CFR 50.71(e) identified i during this audit should be referred to the ap)ropriate regional office for j follow-up or otherwise pursued using other inspec31on and enforcement guidance, j 4.2 LICENSEF PROGRAMS FOR MANAGING COMMITMENTS MADE TO THE NRC-
~
This guidance is intended .to help auditors in evaluating licensee programs related to the revision of commitments made to the NRC. - The audit consists of two parts: (1) procedures and controls; and (2) implementation. Reviewing the licensee's commitment management program procedures in the office will allow more l time for implementation review while onsite. Choose the initial selection of
! commitment changes in the office using licensee-supplied lists of proposed and
! completed commitment changes and any available independent knowledge of recent changes to previn s commitments or activities that would likely affect past l
commitments. In ac. tion, select recent commitments from docketed correspondenae for performing the part of the audit dealing with traceability. At least one week.before the audit, inform the licensee which commitment changes have been selected for possible review. This should minimize the time waiting for the licensee to produce the requested documentation.
! NEI's guidance document is an acceptable guide for licensees to follow for managing and changing their commitments to the NRC. The defined process and controls of the NE- 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 volunteered
- by the licensee have been implemented in accordance with the original licensee l commitment and related schedule. This part of the audit focuses on subsequent '
changes to licensee commitments that may or may not involve interactions with the i NRC. The audit should (1) evaluate the licensee's method for evaluating 3roposed
. changes to regulatory commitments 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 commitment !
L changes to the NRC when such changes are deemed significant to safety or the i NRC's regulatory function.
An important aspect of com itment management that is not addressed in the NEI
- guideline is the part of the process that ensures traceability of commitments.
L The NEI guideline provides a basic framework for evaluating a change to a commitment once licensee personnel propose such a change. However, for those personnel to utilize the NEI guideline. they must realize when a change to a l
l Audit Guide Revision: 11/10/97 L
1
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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 ;) art of a regulatory commitment. Possible ways to provide
. traceability - incluce markings or notations within the procedure and administrative requirements to investigate proposed procedure changes that might affect regulatory commitments. Similar processes would be necessary for design features or other licensee commitments not incorporated into controlled procedures. - -
4.2.1 Procedures and Controls
- a. Verify that the licensee has defined a process for managing commitments made to the'NRC. Such 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 commitments made to the NRC may be included in e stand-alone commitment management system or may be incorporated into other licensee corrective action, licensing, or administrative programs.
Commitment management systems may involve periodic assessments of all outstanding commitments or may evaluate changes on a case-by-case basis.
Indentify the governing procedures and guidance documents and discuss the licensee's commitment 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 p osed changes to commitments.
For example the process may be governed an administrative procedure or other document that is controlled n accordance with facility i technical specifications and quality assurance programs or the process i 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 proposed changes to comitments in terms of safety and regulatory -
significance. The commitment 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 a) proval !
prior to implementation. The process should include a mechan'sm for 1 determining when it would be appropriate to notify the NRC of a ;
commitment change. The NEI guidance document is an acceptable guide for licensees to follow for managing and changing their commitments to the NRC. Ensure that the licensee has integrated the comitment management !
system with other line organization functions to ensure traceability of Revision: 11/10/97 Audit Guide
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- 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 i comparison of the licensee's process, including criteria for evaluation
'of changes and NRC notification, to that recommended in the NEI guide.
l- Although observations regarding the licensee's process' or related
! criteria should be included in the documentation of the audit, any i concerns related to the actual effectiveness of licensee programs should be reinforced by actual examples reviewed in accordance with Item 4.2.2.
j Implementation, of this audit guidance.
4.2.2 Imolementation l
The implementation area of the audit assesses the licensee's performance implementing its commitment change process. Commitments and changes thereto can involve all technical disciplines associated with a nuclear Few auditors are expert in every nuclear-related discipline. Therefore, plant. 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 anticipated based on the commitment changes selected for review. Also acceptable is simply identifying and documentin technical questions for follow-up at alater g (indate the (either documentation. of the by the region audit) 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 a"ect plant i
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 examsle, if you agree that a commitment change was safe and believe it would no; 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 l significant. Failure to recognize that a commitment change required assessment l 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 audit should be forwarded to the appropriate regional personnel for follow-up as part of the NRC's inspection program.
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-a. Commitment Chanaes Reoorted to the NRC. In addition to the selection of.
commitment changes from various sources such as submittals pertaining to licensing actions, responses to bulletins and generic letters, res>onses to NOVs. and LERs, other considerations for selecting commitment c1anges
-for review'are:
{
- 1. Choose changes related to a variety of systems:
l 2. Choose changes involving a variety of engineering disciplines, such as nuclear, mechanical, civil, and electrical: 1
- 3. Choose changes that involve a variety of licensee actions, such as -
~ design modifications, temporary modifications, procedure revisions, 1
_ personnel training.,and revised administrative controls: . ._ . .
- 4. The selected sample of commitments and commitment changes to' be reviewed may need to give preference to recent items since the commitment management systems being evaluated vary in regard to when they were developed and the extent to which past' commitments have been captured:
- 5. Since changes to the FSAR and other programs are, or will be, assessed in NRC inspection procedures, this review should exclude commitments integra;ed 'into the FSAR. Quality Assurance Program, Site Security Plan. Emergency Plan ~ or.other document governed by a change control' mechanism contained in regulations such as 10 CFR 50.59.or 50.54: and
- 6. Give preference to changes related to commitments which were previously considered in an NRC decision-making process. Examples include commitments related to enforcement discretion, resolution of generic safety issues, and resolution of significant inspection issues.
Review each selected commitment change against the requirements and guidance established in the licensee's procedures or guidance. For each change, consider:
e the relationship between the commitment being changed and regulatory requirements (obligations);
o the relationship between the commitment being changed and overall plant safety or risk profile; e the licensee's criteria for determining the acceptability of a proposed commitment change (e.g., the NEI guidance includes the use of the questions from 10 CFR 50.92):
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e systems and components affected by the change (What is the effect of the change on their capability to perform their specified or intended functions?): I e intent of the original comitment (Was comitment related to regulatory com required safety function, or process enhancement?); pliance, e potential effects of commitment change (Has licensee reasonably concluded that revised comitment will maintain plant safety and regulatory compliance, that original commitment was unnecessary or ineffective, or that revised comitment will improve performance?);
e documentation of ~the commitment change -(Each evaluation' of a comitment change should be documented in accordance with the licensee's procedural requirements. Auditors should note that the NRC accepted NEI guidance recomends less documentation for the justification of cciaitment changes than that typically provided in licensee 10 CFR 50.59 safety evaluations or design documents.); and o effective implementation of the revised comitment (Select several ;
comitment changes for verification of implementation. Review l licensee comitment management records, work orders, revised i procedures NRC inspection reports, and other documentation that !
could demonstrate that the specific revised actions were completed )
in accordance with the stated comitment revision and related schedule. Where appropriate, utilize actual physical verifications of equipment and processes.). l
- b. Commitment Chanaes Not Reoorted to NRC. Review each selected evaluation of a comitment change against the requirements and guidance established in the licensee's procedures or guidance. For each change, consider the technical factors listed above as well as the licensee's criteria for determining if the comitment r_hange requires notification of the NRC.
For those comitment changes not requiring NRC notification, ensure that the justification for the change is documented in a record that will be maintained for the life of the facility (maintenance of current licensing basis).
- c. Notifications to the NRC. Verify that each comitment change determined to warrant NRC notification. has been or will be included in either a periodic or individual report to the NRC. Ensure that the description of the comitment change submitted to the NRC is consistent with the action l taken by the licensee,
- d. Iraceability of Commitments. Verify that each sample of a recently implemented comitment would be reasonably identifiable as a comitment l to those licensee personnel most likely to be involved in a subsequent change to the affected design feature or operating practice.
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t 5,0 REPORTING REOUIREMENTS Document the results of this audit in an audit report which summarizes the licensee's commitment management process, specific reviews performed; and other pertinent information (recent changes in programs, planned changes in programs, etc.). The report will be transmitted to the licensee in a standard letter from the project manager.
6.0 ENFORCEMENT-The failure of any licensee to adopt the approach recommended by NEI and acceated by the NRC is not subject to enforcement action. However, an administra;ive action, such as a Notice of Deviation, may be warranted if poor licensee controls of commitment changes resulted in a significant failure to. satisfy.a commitment made to the NRC. In addition. issues regarding completeness and accuracy of information submitted to the NRC may warrant consideration of t".e requirements of 10 CFR 50.9. Suggested items for a Notice of Deviation and apvent violations of NRC regulations, operating licenses, or other regt.atory requirements discovered during execution of this audit must be referred to the appropriate regional office for follow-up or otherwise pursued using other inspection and enforcement guidance.
7.0 COMPLETION SCHEDULE This audit shall be performed and documented for the facilities selected for the pilot effort by May 31, 1998. Subsequent audits or inspections, if necessary, will be determined on the basis of the lessons learned from the first set of audits.
8.0 CONTACT If you have questions regarding this audit guidance, contact William Reckley, NRR/DRPW/PD3-3, at (301) 415-1314, e-mail WDR.
9.0 STATISTICAL DATA REPORTING TAC numbers will be opened for the reporting of time spent in the preparation for and execution of this audit.
10.0 RESOURCE ESTIMATE It is estimated that approximately 125 hours0.00145 days <br />0.0347 hours <br />2.066799e-4 weeks <br />4.75625e-5 months <br /> per facility will be expended in 1 performing this audit. The required time will consist of an in-office review of '
process descriptions, procedures, and documentation related to commitments and commitment changes that has been provided by the licensee in support of the audit i and an onsite portion involving interviews, review of supporting documentation for commitment changes, and verification of implementation of specific l commitments. Subsequent evaluation of the audit reports and pre "
recommendations is estimated to require an additional 100 hours0.00116 days <br />0.0278 hours <br />1.653439e-4 weeks <br />3.805e-5 months <br />. paration of The total i resource estimate, assuming audits at eight facilities, is 1100 hours0.0127 days <br />0.306 hours <br />0.00182 weeks <br />4.1855e-4 months <br />.
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The development of this guidance and the wrformance of the audits have been incorporated into NRR's Operating Plan for :.998 - 1999 as as part of the Reactor Licensing Program as well as being part of the division level operating plan for DRPE/DRPW.
11.0- REFERENCES i
Nuclear Energy Institute's. " Guideline for Managing NRC Commitments." i Revision 2 dated December 19. 1995 (copy attached).
SECY-95-300. Nuclear Energy Institute's Guidance Document. " Guideline for Managing NRC Commitments " dated December 20, 1995.
~
SECY-94-066, " Evaluation of Issues Discussed in SECY-92-314, ' Current Licensing Basis for Operating Plants' " dated March 15. 1994.
SECY-92-314. " Current Licensing Basis.for Operating Plants," dated j September 10, 1992. u i
SECY-94-003. " Plan for Implementing Regulatory Review Group Recommendations."
l dated January 7. 1994.
SECY-97-036. " Millstone Lessons Learned Report Part 2: Policy Issues." dated February 12, 1997. !
SECY-97-042, February 18. 199"Ref.orise to OIG Event Inquiry 96-045 Regarding Maine Yankee." dated 1
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Attachment:
NEI Guideline For Managing NRC Commitments, Rev. 2, 12/19/95
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Revision: 11/10/97 Audit Guide