ML20138E524

Provides Proposed Reduction in Commitment Changes to Unit 1, USAR Section 17.2, QA During Operating Phase, & Plant Commitments Made to Nrc,Per Telcons W/Nrc

ML20138E524
Person / Time
Site:	Davis Besse
Issue date:	04/25/1997
From:	Jeffery Wood CENTERIOR ENERGY
To:	NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM)
References
2401, NUDOCS 9705020302
Download: ML20138E524 (27)

Text

VI .

.t e

,e .

CEPffEHRfC)Rf i EfWEURGY  !

5501 N. State Route 2 419-249 2300 John K. Wood l Oak Hartrar. OH 43449 FAX: 419-321-8337 Vce Presdent . Nuclear l Daws-EMsse l l

l l

Docket Number 50-346 l License Number NPF-3 l

Serial Number 2401 April 25, 1997 I

l United States Nuclear Regulatory Commission l Document Control Desk Washington, D. C. 20555-0001

Subject:

10 CFR 50. 54 (a) (3) Request for Change in QA Program Audit and Surveillance Finding Processing i l

Ladies and Gentlemen:

l The attached provides proposed reduction in commitment changes to the Davis-Besse Nuclear Power Station (DENPS), Unit 1 Updated Safety Analysis Report l (USAR) Section 17.2, " Quality Assurance During the Operating Phase," and DBNPS l

commitments made to the NRC. Pursuant to 10 CFR 50. 54 (a) (3) Toledo Edison (TE)  ;

previously proposed changes to these Quality Assurance program commitments in a j letter dated April 10, 1996 (TE letter Serial Number 2364). Subsequent to the l

April 10, 1996 submittal, several telephone conference calls were held between the NRC Staff and TE to discuss the details of the proposed changes resulting in a revision of the original submittal. This letter supersedes TE's previous ,

submittal in its entirety. '

The proposed changes modify the Quality Assessment (QA) audit and surveillance findings process at the DBNPS. It is proposed that these QA-originated nonconformance documents may be documented and processed through either the existing DBNPS audit / surveillance finding process or the existing DBNPS nonconformance/ corrective action program (i.e., the Potential Condition Adverse to Quality Report (PCAQR) program) in the same manner as other DENPS-identified nonconformances. It is proposed that audit personnel will limit their evaluation of the adequacy of audit finding responses to "significant conditions adverse to quality", rather than to all audit findings. Audits will be allowed i

to be closed after the audit finding is issued and corrective action responsibilities are transferred to line management. Additionally, it is proposed that the DBNPS commitment requiring the completion of Audit Finding Report corrective actions within 120 days be eliminated.

\

9705020302 970425 PDR P

ADOCK 05000346 PDR . } {, ,[ , h'

,l; 3 ";

3

}.

c"s} "ni n'

P

'h ~'g

9.

Docket Number 50-346 License Number NPF-3

, Serial Number 2401 Page 2 Current Program Description The DENPS Quality Assessment (QA) Section performs scheduled audits to meet QA Program and Technical Specification requirements. Currently, Audit Finding Reports (AFR) are used by the QA organization to document nonconformances or program deficiencies noted during the audit process. Findings identified during audits which may affect personnel or plant safety, operability, or may be reportable are also reported immediately to the Manager - Quality Assessment and the Shift Supervisor and documented on a PCAQR. The current program requires a response to each audit finding within 30 days. Responses must identify remedial corrective action (s) and corrective action to prevent recurrence. These actions must be complete within 30 days, or a schedule provided for completion of the corrective actions. The auditor has responsibility for: concurrence with proposed corrective actions, verifying the effectiveness of the completed corrective actions through the close-out process, and performing follow-up effectiveness evaluations of the corrective action during subsequent audit activities.

The PCAQR process is the DBNPS's primary method of reporting and documenting any condition that an individual believes is potentially adverse to quality. This process is used to improve plant operation and safety by identifying issues, observations, or concerns with hardware, programs, or activities regardless of quality classification.

Currently, the PCAQR process requires categorization of the identified PCAQR for significance as Category 1, 2, 3, or 4. A Category 1 PCAQR is defined as a Significant Condition Adverse to Quality with escalated levels of management attention and involvement. A Category 2 PCAQR is defined as a Significant Condition Adverse to Quality. A Category 3 PCAQR is defined as a Condition Adverse to Quality. A Category 4 PCAQR is defined as a minor situation which does not warrant treatment as Category 1, 2, or 3 and that may be processed via other work / action programs. Detailed attributes of each category are contained in DENPS procedure NG-NA-00702, " Potential Condition Adverse to Quality Reporting."

Conditions adverse to quality that are considered significant as defined in USAR Section 17.2.16.2, "Significant Condition Adverse to Quality," are addressed as a Category 1 or 2 PCAQR. These PCAQRs receive DBNPS Director level involvement, a formal root cause evaluation, and follow-up review or audit to verify the adequacy of the corrective actions.

In addition to the QA Program commitments as described in the USAR, DBNPS commitments regarding the audit process are affected by the proposed changes.

These commitments were made by TE in response to NRC Inspection Report (IR)

Number 93-019, dated February 11, 1994 (TE Log Number 1-2982). Toledo Edison's l response (letter Serial Number 1-1036) dated March 14, 1994 to IR Number 93-019, committed to have " corrective actions for audit findings completed by the responsible line organization within 120 days or receive Vice President -

Nuclear approval for extension." The response also stated, "QA will perform our initial assessment of the corrective actions within two weeks of their completion. Follow-up QA review of corrective action effectiveness and final QA closure will be completed on a schedule appropriate for the corrective actions under consideration." The commitment to complete corrective actions for audit

__ , . -- . -- .- ,. . _ _ = _ - - _ _ - - - - .

' # Docket Numbar 50-346 License Number NPF-3 Serial Number 2401

' Page 3

\

i findings within 120 days and to have QA initial assessment and follow-up at prescribed intervals was established to strengthen weaknesses in the QA audit finding process regarding heightening management attention and follow-up, and to l improve the timeliness and adequacy of corrective actions taken in response to l nonconformances identified during QA audits.

3 Pronosed Chances i

Under the proposed changes, nonconformances identified during audits /

surveillances by QA personnel and nonconformances identified by site personnel

may be processed, corrective actions scheduled for completion, and root cause j evaluations performed, if appropriate, under the DBNPS PCAQR corrective action l process rather than the audit finding process. The PCAQR process categorizes l each aonconformance (audit-identified or site personnel-identified) for significance. As described in Attachment 1, audit personnel will limit their evaluation of the adequacy of responses to "significant conditions adverse to i quality" (Category 1 and 2 PCAQRs) identified during audits, including proposed corrective actions and the associated schedule for corrective action completion rather than to all audit findings.

In addition, the commitment to complete corrective actions for audit findings )

within 120 days and the commitment for QA to complete assessment of the  !

j corrective actions within two weeks of their completion are proposed for l e1.imination. I i

1 Conclusion

\ The option for combining of these processes and the elimination of both the self-imposed 120 day - requirement and required follow-up within two weeks for all audit-identified nonconformances provides for greater consistency in: I

processing corrective actions, identification and resolution of significant conditions, establishing accountability with line management for timely and

, effective corrective actions, and escalated management attention to delinquent actions.

4 When used in lieu of AFRs, the PCAQR process provides for timely review, evaluation, reporting and corrective action for potential conditions adverse to quality. The process also provides for PCAQR identification to a review board to ensure proper assignment, prioritization and follow-up. Quality Assessment will remain involved in audit-identified significant conditions adverse to quality to ensure adequate corrective actions are established, completed in a timely manner, and are verified for effectiveness.

These changes, discussed in the attached 10 CFR 50.54 (a) evaluation, have been identified as a reduction to the commitments currently contained in the DBNPS USAR Section 17.2. Although these changes have been identified as a reduction in commitment, the attached 10 CFR 50.54 (a) evaluation demonstrates the QA Program continues to satisfy the criteria of 10 CFR 50, Appendix B.

e Docket Number 50-346 License Number NPF-3 Serial Number 2401 Page 4 In accordance with 10 CFR 50. 54 (a) (3) (iv) , TE understands that these proposed changes will be regarded as acceptable to the NRC within sixty days from the date of this letter, unless TE is otherwise notified.

Should you have any questions or require additional information, please contact Mr. James L. Freels, Manager - Regulatory Affairs, at (419) 321-8466.

Very truly yours, JCS laj Attachments cc: A. B. Beach, Regional Administrator, NRC Region III A. G. Hansen, DB-1 NRC/NRR Project Manager S. Stasek, DB-1 NRC Senior Resident Inspector Utility Radiological Safety Board

Docket Number 50-346 License Number NPF-3 Serial Number 2401 Attachment 1 Page 1 4

i ATTACHMENT 1 DAVIS-BESSE NUCLEAR POWER STATION i

l USAR SECTION 17.2," QUALITY ASSURANCE DURING THE OPERATIONS PHASE" J

A CONTENT AFFECTED BY PROPOSED CHANGE  :

i 3

J d

,1 1

4 s

e

Docket Numbar 50-346 Licensa Number NpF-3 l Serial Humber 2401

, Attachment 1 t Page 2 ,

~

17.2.15 N_0NCONFORMING MATERIALS. PARTS, OR COMPONENTS FORINFORMIONDEY 17.2.15.1 Nonconformance Identification Items or activities which deviate from approved, specifications, codes, drawings, procedures, or other applicable documents, or any or condition that affects the quality of items, services, or program, or prevent a structure, system or component from performing its intended i function is considered to be a nonconformance and is identified as such l and documented. I 5

, When nonconformances are found or suspected, an appropriate status identi- f fication such as the station tagging system, or hold tag is used to preclude l

further activity pending resolution of the adverse condition. Procedures contain provisions to ensure that nonconformances such as equipment l

malfunctions. procedure deviations, defective material and items, and deviations to regulatory requirements are promptly identified, documented.

l evaluated for impact on plant operability, reportability and significance, and corrected.

Nonconformances discovered by suppliers during the manufacturing of l5 materials or items are reported to the Nuclear Group. The supplier's 14 disposition is approved by Engineering or their agent. 19 Whenever a condition adverse to quality is identified that may be detri- l9 i mental to the safety of personnel or safe operation of the plant, immedi. l ate action is taken to notify the Shift Supervisor. If necessary. ~,

notification occurs prior to documenting the condition to ensure control 5 j of the condition or item.

The Manager - Quality Assessment has the authority to stop or delay work 19  !

activities, except reactor operations, at any time after a condition 9 I adverse to quality is identified, if proceeding could jeopardize the quality of an item, adversely affect the quality of subsequent work, or degrade the condition. Co'nditions affecting reactor operations are  ;

reported to the Plant Manager for corrective measures. Hold tags are attached to non-installed nonconforming equipment that has been, evaluated as non-operable and to nonconforming material and items found deficient during the receipt inspection procesr. Nonconforming plant installed equipment is identified through the normal station tagging program. When

• practical, nonconforming items are physically segregated from conforming items. 5 17.2.15.2 Review and Evaluation Documented conditions adverse to quality are reviewed by the initiators supervisor to verify the reported condition. If the condition could affect plant operation, the Shift Supervisor evaluates the condition for 19 impact on Technical Specification requirements and for determination of 5

! the reportability to the NRC or other regulatory agencies, i

l If the condition could affect dry spent fuel storage operation, the Shift l

Supervisor evaluates the condition for impact on the Dry Spent Fuel Storage 20 Cask Certificate of Compliance requirements and for determination of the reportability to the NRC.

17.2-42 REV 20 12/96 i

, ,' Docket Numbar 50-346 License Numbar NPF-3 Serial Number 2401 Attachment 1 *

' Page 3 D-B As part of the evaluation and dispositioning process, nonconforming equipment is evaluated for the ability to perform its intended function and the department responsible for implementing the disposition is design-nated. If the nonconforming equipment cannot perform its intended func- 5 tion, at evaluation of the affected system's operability in accordance with Technical Specifications is performed.

Engineering evaluation of the nonconforming condition includes an assessment 19 to ensure that the item meets the functional requirements, including 5 performance, safety, reliability and maintain 6bility. The engineering evaluation is required to be documented and traceable to the applicable corrective action document.

The acceptability of repaired or reworked items is determined by verifying through inspection or testing that the level of quality obtained for the item 9 is the same as, or at least equivalent to the original quality requirements. .

When the nonconformance has been resolved. Nuclear Assurance personnel 18 signify their concurrence on the corrective action document. 5 Systems which contain nonconforming material or items and which have been declared inoperable due to the nonconforming condition, are not declared operable until documentary evidence is available to verify the material or  !

item is in conformance with specified requirements or a documented evalua-tions provided by Engineering to ensure that it will satisfactorily perform 5 its intended function. ~ ~ ~

17.2.15.3 10CFR21 Reporting Conditions adverse to quality are evaluated and reported in accordance with 14 the provisions of 10CFR21. 5 l

Material or items identified by suppliers as reportable in accordance with 14 10CFR21 are reviewed by Engineering to determine applicability and to 10 initiate corrective actions as appropriate.

Items considered to be reportable under 10CFR21 are reported to the Plant Manager and the Regulatory Affairs Section for notification to the NRC in 18 accordance with the requirements of 10CFR21. 5 l

i 17.2.15.4 Trending Mg g., Q g 4 The Si.; ...

L_ '. . ...____. has established a trending and analysis 18 i program to detect generic problems, adverse quality trends and repetitive 5 l conditions. This program includes the review of documented conditions  !

adverse to quality and significant conditions adverse to quality at a 3 minimum. The specific documents included in the trending and analysis '

program are identified and distributed in accordance with implementing 9 procedures.

5 l

9 17.2-43 REV 19 5,*95

+

I i

, ,' Docket Numbsr 50-346 Licensa Number NPF-3 Serial Numbar 2401 Attachment 1 '

Page 4 l FORINFORMAil0N0KI

! 17.2.16 CORRECTIVE ACTION P

l 17.2.16.1 Ceneral l

l Procedures have been established to ensure that significant conditions l adverse to quality are promptly identified, documented,' evaluated for their significance, and corrected. These procedures require that the completed corrective action be documented and verified, and that the condition be reported to supervisory personnel.

Conditions adverse to quality are also evaluated as to their reportability to the NRC in accordance with the provisions of 10CFR20, 10CFR21, 10CFR50, 5 10CFR70. 10CFR72 OR 10CFR73. 20 5

For significant conditions, the cause is determined and corrective action to preclude repetition identified, and the status is tracked until ccrrec. l tive action is complete and verified. l l

I Corrective action documents contain provisions for identifying the root cause of the condition adverse to quality, the recommended corrective action, and the corrective action taken to prevent recurrence, in addition to the Nuclear Assurance Department's documented concurrence of the adequacy 18 of the corrective action. The Nuclear Assurance Department also has the final review of all corrective action documents for closeout. 5 The quality assurance requirements in procurement documents or contracts "'*

require the supplier or contractor not only to identify material or parts that do not conform to the procurement requirements, but also to determine and correct the causes for the condition adverse to quality. When suppliers furnish items that do not conform to procurement requirements, the 7 nonconformance is documented and evaluated for further action. The actions vary depending on the nature of the nonconformance and the supplier's quality history and may involve obtaining supplier corrective action or supplier reevaluation as a prerequisite for future procurement activities with the supplier. 1 17.2.16.2 Significant Conditions Adverse to Quality 1 Conditions adverse to quality are considered significant when any of the following conditions exist: '

a. The condition requires immediate notification to the NRC in accor-dance with 10CFR50.72 or 10CFR72.75(a) . 20 1

b. A serious failure or breakdown in the implementation of the Nuclear Quality Assurance Program.

c. A significant deficiency in final design as approved and released for implementation, such that the design does not conform to the criteria and basis stated in the Updated Safety Analysis Report (USAR) or Site 20 Certified Safety Analysis Report (CSAR) for dry spent fuel storage.

4 17.2-44 REV 20 12/96

,

• Docket Number 50-346

, Licensa Number NPF-3 Serial Number 2401 Attachment 1 ,

Page 5 I

D-B

d. A significant' deviation from performance specifications or a

- significant deficiency in construction of, and/or modification to '

a structure, system or component which requires extensive evaluation, 5 redesign, or repair to meet the criteria and basis stated in the USAR, site CS4R or to otherwise establish the adequacy of the structure, 20 s'f s tem, or component to perform its intended safety function is 5 discovered.

e. A closed commitment to an outside agency has not been implemented as required. - - - - -

f. A repetitive or adverse trend exists. W bM _

" W d er -

)

g. Failure to resolve a deficiency in 3 timely manner or any condition 5 determined to be significant by the/ Director -: Nuclear Assurance.eeeb 18

th : int:n:: f: ::p:titir: :: ric:::: i: nd. 5 Significant conditions adverse to quality are documented and reported to i the Vice President - Nuclear, and the affected Nuclear Group Directors. 9 When the corrective action to a significant condition adverse to quality 5 has been completed, the Nuclear Assurance Department performs a follow-up 18 I review or audit to verify the adequacy of the corrective action.; 5 i

17.2.16.3 Tracking and Resolution Implementing procedures define the methods employed for tracking and 5 ",

resolving corrective action documents. The responsible Department has the 8 i responsibility to track the status of conditions adverse to quality until 5 )

the implementation of the corrective action has been completed and to assure l that adequate resources are applied to close out the conditions adverse to_ ~

uality in a timely manner.

L se 4 A I

' Audits will verify corrective actions for 17.2.17 QUALITY ASSURANCE RECORDS audit identified significant conditions 17.2.17.1 General (adverse to quality.

Pertinent documentation classified as Quality Assurance Records such as design, procurement, fabrication, inspection, nonconformances and j corrective action, tests, audits, and construction reports; document j reviews, material analysis, and monitoring of work performance; qualifi-cation of personnel, procedures and equipment; drawings, specifications, calibration procedures and reports, NDE procedures and reports; pertinent I operating logs; maintenance and modification procedures; reportable 5 j occurrences; and other records as required by the Technical Specifications l

and the Dry Spent Fuel Storage Cmaks Certificate of Compliance are 20 j retained and available for revier 5 i

A Nuclear Records Management Program, as defined in approved implementing procedures, identifies these records in the nuclksc records list. This d

list is reviewed, approved and revised in accordance with written proce-dures and contains provisions for identifying the records to be retained, identifying the organization (s) with record copy responsibility, specifies the minimum retention period for each record type and specifies the method 17.2-45 REV 20 12/96 l

. ..- - - . - . . - . - . - .- - . . - _ - . - . - - - - - . - . - . - . . - . . ~ . . - - - - -

. Docket Number 50-346

, License Number NPF-3 Serial Number 2401 4 . Attachment 1 Page 6 i

l INSERT "A"

[ Add the following to Section 17.2.16.3, Tracking and Resolution) i  :

l Management of the responsible department is required to review and investigate documented conditions adverse to quality to determine and 3

schedule appropriate corrective action, including action to prevent i recurrence for significant conditions. The responsible department is i also required to respond as requested by the corrective action i document giving results of the review and investigation, including ,

i root cause determination if required. The response shall clearly

' state the corrective action taken or planned, including actions taken  ;

to prevent recurrence if required. The responsible department shall 1

respond to audit identified significant conditions adverse to quality )

I within thirty days and include a scheduled date for the completion of I l corrective action. I i i r

i For significant conditions adverse to quality identified during

' audits, audit personnel will evaluate the adequacy of responses ,

including proposed corrective actions and associated scheduling. '

i i

i

~4 i

3 i

1 1

J 9

N l

l 1

i 4

4 1

. . _ .~. . _ . . _ _

, , ' Docket Number 50-346 License Number NPF-3

' Serial Number 2401 l

Attachment 1 Page 7 D-B filing method, and the method for disposing non-permanent records and hard copy of records being retained on microfilm, including authorization for disposal.

17.2.17.3 Records Storage Facilities for the storage of records have been constructed and located to conform to the req 'irements of ANSI N45.7.9 as modified in Table 17.2-1.

The facility provi. ts the controls to preclude deterioration of the records due to moir ure, temperature and pressure, or other deteriorative conditions approp . .e to the record form such as radiographs, photo- 5 graphs, negativee, and microfilm.

Storage facility control procedures contain provisions that prohibit such activities as smoking, eating, drinking, records reproduction, and film developing in the storage facility. These procedures also describe controls to preclude the entry of unauthorized personnel to guard against larceny and vandalism.

17.2.18 AUDITS 17.2.18.1 Audit Requirements The Nuclear Assurance Department has the responsibility for the implementa- 18 tion of a comprehensive system of planned and periodic audits to verify 5 the compliance and effectiveness of the Nuclear Quality Assurance Program. +

The audits are conducted in accordance with established procedures which l14 incorporate the requirements of ANSI N45.2.12, and are performed by personnel having no direct responsibilities in the areas being audited. Audits are 5 performed as required by the Technical Specifications.

The organizations being audited have the responsibility for ensuring that l9 all request 5for corrective action are promptly answered and 5 actions taken to correct the discrepancy are adequate and timely.

Internal audits of selected aspects of operational activities are per-formed with a frequency consnensurate with their safety significance and in such a manner as to assure that an audit of all activities within the 5 scope of the Nuclear Quality Assurance Program are completed within the time periods specified in the Technical Specification.

T5: yu:1::h. _ n._dM Esse.55mtM

:: c:p:: ___.yperfoms audits of selected suppliers l18 and service contractors to verify and evaluate their Quality Assurance Programs, procedures and activities to ensure that they are effectively complying with specific aspects of the QA program and procurement require-ments which include verification that the suppliers and contractors review 5 i

l and audit the QA programs of their suppliers as required. Suppliers listed on the Approved Vendor 1,ist are audited in accordance with the l requirements uf Regulatory Guide 1.144 as modified in Table 17.2-1.

17.2 47 REV 18 11/93 L i

, ,' Docket Number 50-346 i '

• License Number NPF-3 l Serial Number 2401

! Attachment 1 ,

D-B I

l g dg i t The audit program is reviewed semi-annually by the Company Nucleat Keview 5 I Board or by a Management representative or subcommitte.e designated by the 5 Vice President - Nuclear. to assure the audits are being conducted in 9 accordance with the requirements of the Technical Specifications and th<e 5 Nuclear Quality Assurance Manual.

17.2.18.2 Audit Personnel 5 Audit personnel are provided with appropriate training to ensure that they are competent to perform the required audits. Auditors and Audit Team Leaders are required to be qualified in accordance with the requirements of ANSI N45.2.23 as endorsed by NRC Regulatory Guide 1.146. Technical specialists, who orcasionally act as audit team members, receive the required indoctrination and guidance during the audit.

17.2.18.3 Audit Scheduling and Planning 5 Audits are scheduled in a manner to provide coverage and coordination 9 with ongoing quality assurance program activities, and at a frequency 5 commensurate with the status and importance of the activity and, as specified, in the Technical Specifications. 9 The audit system has provisions for rcheduling audits on short notice to respond to specific quality problems and for conducting unannounced audits. Regularly scheduled audits are supplemented by additional audits -,

for one or more of the following conditions: '

a. W en significant changes are made in the Nuclear Quality Assurance i Program or an approved Supplier's Quality Assurance Program.

l

b. I W en the scope of an approved supplier's activities is significantly 5  :

increased.

c.

E en it is suspected that safety, performance, or reliability may be i I

in jeopardy due to deficiencies in the Nuclear Quality Assurance Program or an approved supplier's Quality Assurance Program.

d. Wen a systematic independent assessment of program effectiveness or item quality or both is considered necessary.

e.

To verify implementation of completed corrective actions to previous-ly identified audit findings which require audit follow-up.

The audit schedules for both the internal and external audits are approved 5 by the Manager - Quality Assessment. 19 9

An audit plan is prepared for each audit that identifies the organization and functional activities or projects to be audited, the scope of the 5 audit and requirements or documents to which the audit will be performed.

the time frame of the audit and names of audit team members. Checklists are also considered to be part of the audit plan.

17.2-48 REV 19 5/95

Docket Number 50-346 License Number NPF-3 Serial Number 2401 Attachment 1 Page 9 i

D-B 9

i l

i 17.2.18.4 Audit Performance 5

Procedures have been developed by Nuclear Assurance that contain provi- IB sions for audit performance activities. These activities include the 5  !

conduct of the pre-audit conference, conduct of the audit, and conduct of i the post-audit conference.

i l

Audit performance activities include an objective evaluation of quality related practices, procedures, and instructions for compliance with applicable Code requirements the requirements of the Nuclear Quality 5 Assurance Manual and the Technical Specifications. Audits also verify that activities comply with the requirements of the quality related practices, and procedures, and that records reflect that the Nuclear Quality Assurance Program and its implementing procedures are effective and are being l9 ,

properly implemented.  !

I 5

Conditions adverse to quality discovered during an audit that may affect the safe operation of the plant are immediately brought to the attention ,

of the Manager - Quality Assessment and the Shif t Supervisor. )

19 l 17.2.18.5 Audit Reporting 5 i

. . . :n Upon completion of the audit, an audit report is signed by the Audit Team Leader audit and approved by the Manager - Quality Assessment. The content of the 19 report complies with ANSI N45.2.12 and is distributed to management 5 of the audited organizations the Vice President - Nuclear (excluding external 19 supplier audits): Company Nuclear Review Board, and the Station Review 9 Board if the audit findings involve station activities. The audit report is required to be issued within thirty (30) days of the post-audit conference. 5 For external audits and audits of contractors, the audit report transmittal also includes the responsible management of the contractor and the department responsible for administration and technical control of the 14 project.

5 A

or w ittetion aniz respo w thinse to ach an it fi ing i requfedfrmth[ audit /d irty ( 0) da s fol wing ssuan of he au it 5 f ach ndinespon

, exce t whe a sho er pe iod i spec led o the pudit inding is r quired o ele rly i entif the edlyl cor etive etion and t e cory ctive actio take to prevent recurr9nce l9 in he ev t the corre tive pction anno be co7pletpd wit) n thi[r y d ys, th reas 5 and e scheduled date r completi n is 'equire in t espons .

17.2[8.6F low-u Up n noti icati 5 h s bee the emedi 1/cor ectiv act) n to preven rec rent comply ed, y prop ate 110w- pmefsure such p rea ng When a condition adverse to quality is identified, the condition i documented and processed as described in Sections 17.2.15 and 17.2.16.

17.2-49 REV 19 5/95

Docket Number 50-346 1 License Number NPF-3 '

Serial Number 2401 Atta,chment 1 Page 10 D-9 l "r-d tr confi r that th::: :::i::: Fr:

u.-rd!! fr rz! derm cle M en the d:te cheb::: :::icft::::ily .::; ,lich:3- -

'5

.... e s s a a -,--.a 211 Mit findirg: Fr

11. Z. . l f. 6

-17.2.18.i surve111ances sur.eillance activities, planned o audit system and the inspection syrr unplanned, are used to supplement the 5 Huclear Quality Assurance Program.Atem

-, a a. . 4 ~.

to assure adequate coverage of the S r>:!'l-- 5

.u ..,

41, .~.e , < < p- pge , :.:g afiMir;: :: :x:::::d :: 5

-findir; ::=.:: 5: :.:::x t:d :: r. .-^r :M - If th:

Ic:l=d d=fr; th: ::=:: ;f th: :;n:il- 5 5

?r.n, the deficirr; i dr~ rtM. --d pr^a rrM M 2 F8-dir; Pr;rt. 9 19 When a condition adverse to quality is identified, the condition is documented and processed as described in Sections 17.2.15 and 17.2.16.

^

[ m e_ A N t. W 5 a.c,\ \tn 2 g m~ -- _ -

17.2.18.7 Resolution of Audit and Surveillance Findings Management of the audited organization is required to review and investigate any- audit or surveillance findings to determine and schedule appropriate corrective action, including action to prevent recurrence for significant conditions, in accordance with Section i

)

l 17.2.16.3.

1 17.2.19.8 Close-out of Audits and Surveillances Audits and surveillances can be considered closed after the audit I

report or surveillance report is issued and identified conditions adverse to quality, if applicable, have been documented in accordance with Sections 17.2.15 and 17.2.16. I

/ 17.2.18.9 Follow-u_p.

j i

Audits are conducted to verify implementation of completed corrective 1

[ actions to previously identified audit findings requiring audit follow-up, including significant conditions adverse to quality.

l

' Periodic audits will also review results of actions taken to correct deficiencies occurring in unit equipment, structures, systems or method of operation that affect nuclear safety (Tech Spec 6.5.2.8.c).

17.2-50 PIV 9 7/g9 t

p

• Table 17.2-1 (Continued) ,

APPI.ICAB1E WC RK1JUGIRY fMTTE, #EI Sr#DWDS, #D DUEIRY 0]ES *

!PC REMAmY GIIIE, DUEIRY (YYn # EI St# D 2 DS [KVIS-BESSE F051TICN l14 y 3, to t* t1 4* mnaro

1. EI/#5 3.2-1982, 1. thvis-Besse comits to the tuulatory position 14 toanna

%inistrative Contrels and Onlity Assurance for of this stardard with the follan,tg clarificatioln mg7@l 8 s :r r m o Ibclear Ibwer Plants" sa e A. Section 1.1

$@zc

• res that this starulard be h b "fmetions applied to aYactivities tinse to the safety affecting !Oclear

' H S important ot " @

Power Plant Structures, Systens and n u m Ccmpments". Davis-Besse shall apply the l14 requirenents of this standard to those

• i@

systems structures and amponets drich emw are clas,sified as "0". The term "0" is i 6 t defined as follows:

Ttese ruclear safety-relatal system ard com-ponets that are relial upcm to remain fme- 8 ticral durirg design basis evmts to ensure: >

(1) The intgrrity of the Reactor Coolirg Bomdary.

(2) mainta 1he cab it in safe dutdown ccmdition andhility to dot down the rector and l8 (3)1he capability to prevet or altimate the con-sequeces of accidints that auld result in en o eminrable to the "T1 Cll3 "l%3

==

E m

Q ll%ll3 ms DJun

%A3

~4 emne .

17.2-53 REV 14 7/91 O im

r. am p 6

5'S'as alsman paw

"*d  ;

.w#

e 4

V.

e D-B Table 17.2-1 (Cmtinued)

APPLICABLE ISC REDUUdORY GJIIES. ANSI STMDGDS, MO DOUSTRY CODES ISC FB21A10RY GJIIE, ENE[@

to rr N oo It G S11er e ANSI STR OU E DAVIS-BESSE POSITICN l14 apnaX

4. ANSI /ANS 3.2 (Ccntirued) B. Sectim 1.2 cmtrols and s the "the adninistrative ty Assurance provisims of s@$$$

ua a the standard 1 be applied to other * %  %

" C inportet plant equipmt at a level ccmuensurate with the inportance of the equ2 pent N=@n

& g,&

to reliable and efficient lant geration." H ao a In lieu of this of this standard

, the reguirensts I apply to Q-Listed itens 14 "@"

u tn

• Zo as discussed above and to AQ-Listed itens.

lhe applicability to AQ classified itens and to those activities that can affect the quality

@0 i*

'd

• or safe operaticn of these itens is accmplished in a graded numer.

C. Secticn 2.2 - In lieu of the definition of

• Tn=r=crim* in this standard, Davis-Besse (14 casunts to the definiticn of inspection as delineated in ANSI N45.2.10,1973.

D. Secticn 3.4.3 requires that perscrnel qualified in the tecimical areas indi- 5 cated be ca_pahle of respmiing within two hours for the pirpose of providing technical advice to the Shift Supervisor cn a 24 hr.-a-day basis. In lieu of the specified two hour respcnse tine, the response times delineated in the Davis-g Besse Brergecy Plan shall be utilized.

L

1. .E.'" Sect'lan 5.2.1.6 - In lieu of the require- 16 p* sents diich limit the scheduled work tine of the required shift emplenet of licensed operators avi smier operators and the shift tectnicalA Davls-Besse ccamits to the ts as delineated in Davis-Besse thcles r Staticn thit 1 Technical Spec ications Secticn 6.0.

ahmoc 17.2-54 REV 16 7/92

-- -. .. - - - . . . _ . - . - - - - - . _ . . . . . . - - _ _ _ - - ~ . . . ._. - - . - . . .

Dockat Numbar 50-346

' ,' , Licanae Number NPF i

.; Serial Number 2401 Attachment 1

~

Page 13 s

5

l l I

~

I l 4

INSERT "B"

}

[ Add new Position 17.2-1.4.E:}

} " Sections'4.2.10 and 4.2.11 of ANSI /ANS 3.2 require that written

. programs for both independent audits and reviews contain provisions ,

tos-

! )

i

• Assure tLaely response to review and audit findings by the subject organization, and j

• Require notification of-appropriate management if agreed to follow-  !

I up action resulting fram a review or audit is not implemented  ;

'within the agreed to time period. i I i 4

lta satisfying the intent of these requirements, all audit findings shall be documented and processed in accordance with the Corrective  !

l Action program which requires: I i

• Responsible management of audited organizations to review and  !

i investigate documented conditions adverse to quality to determine 5

and schedule appropriate corrective actions, including action to ,

prevent recurrence for significant conditions, i i

• Responsible management to respond as requested by corrective action documents giving results of theit reviews and investigations, including root cause determination if required.

,

• Responsible management responses to state the corrective actions '

taken or planned, including action taken to prevent recurrence if  !

l required. ,

• Responsible management responses to audit identified significant  !

! conditions adverse to quality within thirty days to include i

[ scheduled dates for the completion of corrective actions.

[

• Audit personnel to evaluate adequacy of the responses, including ,

j

! proposed corrective actions and associated scheduling, dor audit identified significant conditions adverse to quality.

.

• Nuclear Assurance Department follow-up reviews or audits, as j l appropriate, to verify adequacy of completed corrective actions to i

! significant conditions adverse to quality.  !

i

• Audit verification of corrective actions for audit identified  ;

i significant conditions adverse to quality.  ;

1

)

4 l

I

}

e l

l 4

4 1-5 4r, .-

-.,,m. s --- -

.- _ - - _y. .-, 4,

D-B

.P l i

Table 17.21 (Ccntinued)

. e ty i APPLICABE NRC FIEL8.AIMY GUIIES, ANSI STROGDS, AND INDUSTRY GIES g <g g y 0 . !

m , we x

!TC FIEUUGGY GUIIE, omoe i INDUSTRY QIES ANSI STANDARDS DMTIS-BESSE POSITION [{Hg"[

l14

16. Pegulatory Guide 1.123 Ccntinued

, oz z:

[14 3 g B. Section 10.2.d of ANSI N45.2.13 is interpreted as follows: The person emhe i attestm' g to a certificate shall be 5 u vi !

an authorized and te ible splayee *zo of the lier and 11 be identi- @O<

fied by supplier. 4*, *

17. Guide 1.144, ANSI N45.2.12-1977 Re- 1. Davis-Besse cemits to the regulatory Pegulatory/80 Rev. 1, 9 ' Auditing of s for Aud1 ting positicn of this guide. l14  !

Quality Assurance Program for ~

Assurance Program 5

• tuclear Power Plants

• r lear Power Plants". ,

2. Davis-Besse cemits to the requirenents l14 i of this standard with the following clari-ficaticn: i 5 t

, A. Secticn 2 of ANSI N45.2.12 prwides e

requiremnts for the training armi l gualificaticn of auditing perscrinel.

In lieu of this requirment, Davis- 14 3 Besse shall qualify its auditors in 20 accordance with the requireients of 5 In3e4*,C* Fegulatory Guide 1.146.

s -

L s

I l

?

i i

17.2-71 FH 20 12/% I 3

• Docket Number 50-346 License Number NPF-3 Serial Number 2401 t

Attachment 1 Page 15 INSERT "C"

~

f

' [ Add Position 17.2-1.17.2.B:]  !

" Sections 3.2.5 and 3.3.7 of ANSI N45.2.12 require that the Audit '

system provide provisions for verification of effective corrective action of adverse audit findings and identified quality assurance program deficiencies on a timely basis.

l In satisfying the intent of these requirements, the Corrective Action  !

and Audit programs shall contain provisions for the actions outlined l in Position 17.2-1.4.E."

' [ Add Position 17 . 2 - 1.17 . 2 . C : ]

" Sections 4.3.2.4 and 4.3.2.5 of ANSI N45.2.12 require that when a nonconformance or quality assurance program deficiency is identified as a result of an audit:

• The audit finding be acknowledged by a member of the audited organization, and

• Further investigation be conducted by the audited organization in an effort to identify the cause and effect and to determine the extent of the corrective action required.

In satisfying the intent of these requirements, the Corrective Action and Audit programs shall contain provisions for the actions outlined in Position 17.2-1.4.E."

<4

[ Add Position 17 . 2 - 1.17 . 2 . D : ] l "Section 4.5.1 of ANSI N45.2.12 requires that:

l

• Management of the audited organization respond to audit findings as l requested by the audit report, l

• In the event that corrective action to audit findings cannot be I completed within thirty days, the audited organization's response include a scheduled date for the corrective action, and

• The audited organization provide a follow-up report stating the corrective action taken and the date corrective action was completed.

In satisfying the intent of these requirements, the Corrective Action and Audit programs shall contain provisions for the actions outlined in Position 17.2-1.4.E."

[ Add position 17. 2 - 1.17. 2 . E : ]

"Section 4.5.2 of ANSI N45.2.12 requires that, when necessary, follow-up actions for audit findings be performed by the audit team leader or management of the auditing organization through communication, re-audit, or other appropriate means to:

• Obtain written response to the audit findings from management of the audited organization when required by the audit report, i

Evaluate adequacy of the audited organization's response to the l audit findings, l

• Assure management of the audited organization identifies and l schedules corrective action for each audit finding, and I

• Confirm management of the audited organization accomplishes corrective action to audit findings as scheduled."

In satisfying the intent of these requirements, the Corrective Action and Audit programs shall contain provisions for the actions outlined in Position 17.2-1.4.E." l

, , Docket Number 50-346

,,,, , License Number NPF-3 Serial Number 2401 Attachment 2 Page 1 ATTACHMENT 2 DAVIS-BESSE NUCLEAR POWER STATION EVALUATION OF l PROPOSED QUALITY ASSURANCE PROGRAM l REDUCTIONS .. <

l i

i t

l l

l l

l I

, , Docket Number 50-346

, Licensa Number NPF-3 Serial Number 2401 Attachment 2 Page 2 10 CFR 50. 54 (a) EVALUATION FOR USAR CHANGE NOTICE (UCN)95-033 Changes to Corrective Action and Audit Processes

SUMMARY

OF CHANGES The proposed changes to the Updated Safety Analysis Report (USAR) Section 17.2,

" Quality Assurance During the Operations Phase," (Nuclear Quality Assurance Program) involve " reductions" in commitments under 10 CFR 50.54 (a) and several supporting "non-reduction" changes.

The proposed reduction changes:

Limit " thirty days" as a prescribed time-limit for completion of audit finding responses to significant conditions adverse to quality,

. Limit prescribed audit finding corrective action root cause determination and action to prevent recurrence to significant conditions adverse to quality, Limit audit personnel's evaluation and verification of audit finding response, scheduling, and corrective action to significant conditions, and

. Allow close-out of audits /surveillances separate from processing / closure of associated audit / surveillance-identified conditions adverse to quality.

The proposed supporting non-reduction changes:

. Assign additional quality assurance duties to Quality Assessment, Provide better interface with the existing corrective action system, and

. Make editorial changes, correct typographical errors, and renumber steps.

REFERENCES 10 CFR 50 Appendix B 10 CFR 50. 54 (a)

ANSI /ANS-3.2-1982 ANSI N45.2.12-1977 USAR Section 17.2 UCN 95-033 PROPOSED CHANGES See marked-up pages of USAR Section 17.2 (attached).

DESCRIPTION OF CHANGES

1) 17.2.15.4, Page 17.2-43: Replace " Director - Nuclear Assurance" in the 1st sentence with " Manager - Quality Assessment".

[already approved under NRC Log 1-3573 (4/95)]

2) 17.2.16.2, Page 17.2-45: Add the Manager - Quality Assessment to item "g" as

" Failure to resolve a deficiency in a timely manner or any condition determined to be significant by the Manager - Quality Assessment or Director -

Nuclear Assurance."

[previously approved under NRC Log 1-3573 (4/95)]

' ,' ,' , Docket Number 50-346 License Number NPF-3 Serial Number 2401 4

l Attachment 2 l l

Page 3 1 1

3) 17.2.16.2, Page 17.2-45: Eliminate the item "g" phrase "such as the existence of a repetitive or adverse trend" which is redundant to item "f".

4) 17.2.16.2, Page 17.2-45: Add the following to the last paragraph: " Audits will verify corrective actions for audit identified significant conditions adverse to quality."

5) 17.2.16.3, Page 17.2-45: Add to Section 17.2.16.3 as shown in Insert A:

" Management of the responsible department is required to review and investigate documented conditions adverse to quality to determine and schedule appropriate corrective action, including action to prevent recurrence for significant conditions. The responsible department is also required to respond as requested by the corrective action document giving results of the review and investigation, including root cause determination if required. The response shall clearly state the i corrective action taken or planned, including actions taken to prevent recurrenco if required. 1 The responsible department shall respond to audit l identified significant conditions adverse to quality within thirty days and include a scheduled date for the completion of corrective action.

For significant conditions adverse to quality identified during audits, audit personnel will evaluate the adequacy of responses including proposed corrective actions and associated scheduling."

6) 17.2.18.1, Page 17.2-47: Correct typo " request" in the 2nd paragraph.

7) 17.2.18.1, Page 17.2-47: Replace "The Nuclear Assurance Department" in the 1st line of the 4th paragraph with " Quality Assessment" to specify the responsible section.

8) 17.2.18.5, Page 17.2-49: Add "When a condition adverse to quality is identified, the condition is documented and processed as described in Sections 17.2.15 and 17.2.16."

9) 17.2.18.5, Page 17.2-49: Remove "A written response to each audit finding is required from the audited organization within thirty (30) days following issuance of the audit finding, except when a shorter period is specified on the audit finding. Each response is required to clearly identify the remedial corrective action and the corrective action taken to prevent recurrence."

(see item #5 above).

g" ,' Docket Number 50-346 License Number NPF-3 Serial Number 2401 Attachment 2 Page 4

10) 17.2.18.5, Page 17.2-49: Remove "In the event that corrective action cannot be completed within thirty days, the reason and the scheduled date for completion is required in the response." (see item #5 above).

11) 17.2-.18.6, Page 17.2-49: Remove 17.2.18.6 " Follow-uo - U p on notification the remedial / corrective action to prevent recurrence has been completed, appropriate follow-up measures such as reading is..." (see item #18 following) .

12) 17.2.18.6, Page 17.2-50.: Remove 17.2.18.6 " Follow-up - ...used to confirm that these actions have been satisfactorily accomplished. An audit is considered closed on the date when all audit findings have been verified and closed." (see item #17 following).

13) 17.2.18.7, Page 17.2-50: Renumber to 17.2.18.6 to reflect elimination of 17.2.18.6 (see items #11 and #12 above).

14) 17.2.18.7, Page 17.2-50: Add "When a condition adverse to quality is identified, the condition is documented and processed as described in Sections 17.2.15 and 17.2.16."

15) 17.2.18.7, Page 17.2-50: Eliminate the second and third sentences

" Surveillance findings are corrected or resolved during the surveillance, if possible. If the finding cannot be corrected or resolved during the course of the surveillance, the deficiency is documented and processed via a Finding Report."

(see item #14 above).

16) (Page 17. 2-50) : Add new Section 17.2.18.7:

Resolution of Audit and Surveillance Findinas -

Management of the audited organization is required to review and investigate audit or surveillance findings to determine and schedule appropriate corrective action, including action to prevent recurrence for significant conditions, in accordance with Section 17.2.16.3."

17) (Page 17. 2-50) : Add new Section 17.2.18.8:

"Close-out of Audits and Surveillances -

Audits and surveillances can be considered closed after the audit report or surveillance report is issued and identified conditions adverse to quality, if applicable, have been documented in accordance with sections 17.2.15 and 17.2.16."

8

• , . Docket Number 50-346

' '

• License Number NPF-3 i Serial Numbar 2401 .

Attachment 2 1 l

Page 5

18) (Page 17.2-50) : Add new Section' 17.2.18.9:

" Follow-up - Audits are conducted to verify implementation of completed corrective actions to previously identified audit findings requiring audit follow-up, including significant conditions i adverse to quality. Periodic audits will also  !

review results of actions taken to correct deficiencies occurring in unit equipment, structures, systems or method of operation that af fect nuclear safety (Tech Spec 6.5.2.8.c) . "

19) Table 17.2-1: Add new Position 17.2-1.4.E as shown in Insert B:

" Sections 4.2.10 and 4.2.11 of ANSI /ANS 3.2 require that written programs for both independent audits I and reviews contain provisions to:

• Assure timely response to review and audit findings by the subject organization, and f Require notification of appropriate management if agreed to follow-up action resulting from a review or audit is not implemented within the agreed to time period.

In satisfying the intent of these requirements, all i audit findings shall be documented and processed in accordance with the corrective Action program which requires: i Responsible management of audited organizations to review and investigate documented conditions adverse to quality to determine and schedule appropriate corrective actions, including action to prevent recurrence for significant conditions.

Responsible management to respond as requested by corrective action documents giving results of their reviews and investigations, including root cause determination if required.

• Responsible management responses to state the corrective actions taken or planned, including action taken to prevent recurrence if required.

• Responsible management responses to audit identified significant conditions adverse to quality within thirty days to include scheduled dates for the completion of corrective actions.

• Audit personnel to evaluate adequacy of the responses, including proposed corrective actions and associated scheduling, for audit identified significant conditions adverse to quality.

• Nuclear Assurance Department follow-up reviews or audits, as appropriate, to verify adequacy of completed corrective actions to significant conditions adverse to quality.

8 Docket Number 50-346 License Number NPF-3 Serial Number 2401 Attachment 2 Page 6

• Audit verification of corrective actions for audit identified significant conditions adverse to quality.

20) Table 17.2-1: Correct typo " adviser" in Position 17.2-1.4.E.

21) Table 17.2-1: Renumber Positions E, F and G to F, G and H in 17.2-1.4 to add new "E" (see item #17 above).

22) Table 17.2-1: Add Position 17.2-1.17.2.B as shown in Insert C:

" Sections 3.2.5 and 3.3.7 of ANSI N45.2.12 require that the Audit system provide provisions for verification of effective corrective action of adverse audit findings and identified quality assurance program deficiencies on a timely basis.

In satisfying the intent of'these requirements, the Corrective Action and Audit programs shall contain provisions for the actions outlined in Position 17.2-1.4.E."

23) Table 17.2-1: Add Position 17.2-1.17.2.C as shown in Insert C:

" Sections 4.3.2.4 and 4.3.2.5 of ANSI N45.2.12 require that when a nonconformance or quality assurance program deficiency is identified as a result of an audit:

• The audit finding be acknowledged by a member of the audited organization, and Add Position 17.2-1.17.2.C:

• Further investigation be conducted by the audited organization in an effort to identify the cause and effect and to determine the extent of the corrective action required.

In satisfying the intent of these requirements, the Corrective Action and Audit programs shall contain provisions for the actions outlined in Position 17.2-1.4.E."

24) Table 17.2-1: Add Position 17.2-1.17.2.D as shown in Insert C:

4 "Section 4.5.1 of ANSI N45.2.12 requires that:

• Management of the audited organization respond to audit findings as requested by the audit report,

• In the event that corrective action to audit findings cannot be completed within thirty days, the audited organization's response include a scheduled date for the corrective action, and

• The audited organization provide a follow-up report stating the corrective action taken and the date corrective action was completed.

In satisfying the intent of these requirements, the corrective Action and Audit programs shall contain provisions for the actions outlined in Position )

17.2-1.4.E." I l

)

_ _ _ _ _ __m - _ __.__- _ - _ _ _ _ _ _ . . . ._ ___

y[

Docket Number 50-346

' ' License Numbar NPF-3 Sorial Number 2401 Attachment 2 l Page 7 l I

25) Table 17.2-1: Add Position 17.2-1.17.2.E as shown in Insert C: {

"Section 4.5.2 of ANSI N45.2.12 requires that, when necessary, follow-up actions for audit findings be i performed by the audit-team leader or management of the auditing organization through communication, re-audit, or other appropriate means to:

• Obtain written response to the audit findings from management of the audited organization when required by the audit report,

• Evaluate adequacy of the audited organization's response to the audit findings,

• Assure management of the audited organization identifies and schedules corrective action for each audit finding, and

• Confirm management of the audited organization accomplishes corrective action to audit findings as scheduled.

In satisfying the intent of these requirements, the Corrective Action and Audit programs shall contain provisions for the actions outlined in Position 17.2-1.4.E."

1 I

REASON FOR AND EFFECT OF CHANGES The USAR description of ownership in the audit program will emphasize the ANSI N45.2.12 requirement for responsible management to review and investigate any adverse audit findings to determine and schedule appropriate corrective action.

Exceptions will be made to ANSI N45.2.12-prescribed time limits, corrective action levels, and in-line audit personnel follow-up for audit finding corrective actione to define applicability to significant conditions adverse to quality. The ANSI N45.2.12-prescribed requirement for audit packages to remain open until all audit-identified findings are resolved will be modified to allow closure of audits /surveillances after the applicable report is issued and corrective action responsibilities are transferred to line management.

Technical Specification 6.5.2.8.c, USAR 17.2.16.2, and USAR 17.2.18.3.e still require Nuclear Assurance to verify effectiveness of the corrective action program through such activities as periodic audits and reviews after the corrective actions have been completed.

Under the proposed changes, nonconformances identified during audits /

surveillances by QA personnel may be processed, corrective actions scheduled for completion, and root cause evaluations performed, if appropriate, under the existing audit finding process, or under the existing PCAQR corrective action process. The PCAQR process categorizes each nonconformance (audit-identified or site personnel-identified) for significance and assigns response due dates. The well-established PCAQR process provides for timely review, evaluation, reporting and corrective action for potential conditions adverse to quality. The process also provides for PCAQR identification to a review board to ensure proper assignment, prioritization and follow-up. Audit personnel will continue to evaluate the adequacy of responses to significant conditions adverse to quality (Category 1 and 2 PCAQRs, and significant audit findings) identified during audits, including proposed corrective actions and the associated schedule for i

I

,f Docket Number 50-346

• License Number NPF-3 0 ** ' Serial Number 2401 Attachment 2 l

' Page 8 i l

corrective action completion. However, the adequacy of responses to audit findings of minor significance identified during audits will not be required to be evaluated by audit personnel.

These proposed changes will reduce in-line Quality Assessment responsibility for corrective action evaluation / verification and, therefore, allow for more effective allocation of auditing resources to activities considered more significant in the monitoring of Nuclear Quality Assurance Program effectiveness. In addition, the changes will provide a better description of Quality Assessment duties, improve the interface between the audit program and ,

the corrective action system, correct typographical errors, renumber steps, and make editorial changes. l l

BASIS FOR CONCLUSION THAT REDUCTIONS CONTINUE TO SATISFY 10 CFR 50 APPENDIX B {

While some of the proposed changes are considered reductions to existing Nuclear Quality Assurance Program commitments, the requirements of associated 10 CFR 50 '

Appendix B nonconformance, corrective action, and audit criteria will not be affected.

As required by 10 CFR 50 Appendix B Criterion XVIII, " Audits", audit results will continue to be documented and reviewed by management having responsibility in the area audited. Follow-up action, including reaudit of deficient areas, I

will continue to be taken as outlined in the proposed USAR Section 17.2.18 and  !

USAR Table 17.2-1 Position 4.E.

l As required by 10 CFR 50 Appendix B Criterion XVI, " Corrective Action",

conditions adverse to quality and nonconformances will continue to be promptly identified and corrected. In the case of significant conditions adverse to quality, the corrective action process will assure that the cause of the I

condition is determined and corrective action taken to preclude repetition. The I DBNPS corrective action process commitments for audit-identified and site I personnel-identified nonconformances are as described in the proposed USAR 1 I

Section 17.2.16.

These changes will not reduce the effectiveness of any program as all systematic requirements will continue to be satisfied by the Davis-Besse Nuclear Quality Assurance Program.