ML20101Q794
| ML20101Q794 | |
| Person / Time | |
|---|---|
| Site: | Davis Besse  |
| Issue date: | 04/10/1996 |
| From: | Stetz J CENTERIOR ENERGY |
| To: | NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM) |
| References | |
| 2364, NUDOCS 9604150220 | |
| Download: ML20101Q794 (25) | |
Text
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%CV ENERG1f 300 Modmon Awenue John P. teatr Toledo, OH 43652M1 Vice Pneident . Nuclear -
419-240-2300 Dovts-Beses Docket Number 50-346 License Number NPF-3 Serial Number 2364 April 10, 1996 United States Nuclear Regulatory Commission Document Control Desk Washington, D. C. 20555
Subject:
Request for Change in Quality Assurance Program Audit and Surveillance Finding Processing Ladies and Gentlemen:
In accordance with 10CFR50.54 (a)(3), Toledo Edison (TE) hereby submits its l plans regarding changes in the processing of Quality Assessment (QA) audit and surveillance findings at the Davis-Besse Nuclear Power Station (DBNPS),
Unit 1. It is proposed that these QA-originated nonconformance documents be documented and processed through the existing DBNPS nonconformance/
corrective action program (i.e., the Potential Condition Adverse to Quality (PCAQ) Program) in the same manner as other DBNPS-identified nonconformances.
These changes, discussed in the attached 10CFR50.54 (a) review, have been identified as a reduction to the commitments currently contained in the DBNPS Updated Safety Analysis Report (USAR) Chapter 17.2, Quality Assurance Program for Station Operation. Although these changes have been identified as a reduction in commitment, the attached 10CFR50.54 (a) review demon-strates the Quality Assurance (QA) Program continues to tisfy the criteria of 10CFR50, Appendix B.
In addition to changes to the QA Program as described in the USAR, manage-ment commitments regarding the audit process were also identified as being affected. These commitments were made in response to Inspection Report I (IR) Number 93-019, dated February ll, 1994 (TE Log Number 1-2982).
E-1500 %
9604150220 960410 PDR ADOCK 05000346-p PDR c3 Operating Companies: h Cleveland Electnc lituminating I Toledo Edison ll'
.S
Docket Number 50-346 License Number NPF-3
, Serial Number 2364
.Page 2 They were made to strengthen weaknesses in the QA audit finding resolution process regarding heightening management attention and follow-up, and to improve the adequacy of corrective actions taken in response to nonconform-ances identified during QA audits.
Toledo Edison's response, dated March 14, 1994 (TE letter Serial Number 1-1036) 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 findings within 120 days and to have QA initial assessment and follow-up at prescribed intervals was chosen by TE management to heighten site awareness and ensure corrective actions were performed in a timely manner.
These commitments, made in response to IR Number 93-019, are being modified. Under the proposed changes, nonconformances identified during audits by QA personnel and nonconformances identified by site personnel will be processed similarly under the DBNPS corrective action process (PCAQ). The combining of these processes provides consistency in the processing of corrective action documents by requiring QA-identified nonconformances found during audit /surveillances to be processed, evalu-ated, reviewed, completed, and closed out by the DBNPS nonconformance (PCAQ) process. Management of the responsible department will review and investigate all documented conditions adverse to quality (nonconformances) to determine and schedule appropriate corrective action and to close-out the condition adverse to quality in a timely manner.
These changes increase line management's accountability for timely and thorough corrective action under the DBNPS corrective action process.
This reliance on responsible management for close-out will permit Quality Assessment to focus on verifying the effectiveness of corrective actions I for audit / surveillance-identified nonconformances and DBNPS-identified nonconformances through audits and reviews as required by Technical Specifications and the USAR Quality Assurance Program. These changes also provide for more effective allocation of Quality Assessment auditing resources to areas considered more significant.
l The proposed changes are based on similar changes which were implemented at i the Union Electric Company's Callaway Plant in May, 1992. Toledo Edison I requests that the NRC approve these proposed changes for the DBNPS Quality l Assurance Program within the next 60 days in accordance with 10CFR50.54 (a) (3) (iv) .
. 3 Docket Number 50-346 l License Number NPF-3 i Serial Number j
.Page 3 l If you have any questions regarding this proposal, please contact Mr. James L. Freels, Manager - Regulatory Affairs, at (419) 321-8466.
Very truly yours, J. P. Stetz lh Attachments cc: L. L. Gundrum, DB-1 NRC/NRR Project Manager H. J. Miller, Regional Administrator, NRC Region III S. Stasek, DB-1 NRC Senior Resident Inspector Utility Radiological Safety Board
-Docket Number 50-346
, , License Number NPF-3 Serial Number 2364
. Attachment 1 Page 1 I
l ATTACHMENT 1 :
DAVIS-BESSE NUCLEAR POWER STATION USAR CHAPTER 17.2," QUALITY ASSURANCE PROGRAM FOR STATION OPERATION" CONTENT AFFECTED BY PROPOSED CHANGE 4
. Ei n " E n
' Serial Number 2364 INFORMATION ONLY
. Attachment 1 Page 2 D-D 17.2.15 NONCONFORMING MATERIALS, PARTS, OR COMPONENTS 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 f rom performing its intended function is considered to be a nonconformance and is identified as such and documented.
5 When nonconformances are found or suspected, an appropriate status identi-fication such as the station tagging system, or hold tag is used to preclude further activity pending resolution of the adverse condition. Procedures contain provisions to ensure that nonconformances such as equipment malfunctions, procedure deviations, defective material and items, and deviations to regulatory requirements are promptly identified, documented, 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 mental to the safety of personnel or safe operation of the plant, immedi-ate action is taken to notify the Shift Supervisor. If necessary, notification occurs prior to documenting the condition to ensure control 5 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 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. Conditions 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 j as non-operable and to nonconforming material and items found deficient during the receipt inspection process. 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 I affect plant operation, the Shif t 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.
- 17.2-42 REV 19 5/91
Docket Number 50-346 I P A E E
. License Number NPF-3
' Serial Number 2364 l f gg (. .
. 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, an 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 maintainability. 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 Material or items identified by suppliers as reportable in accordance with 14 4
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 17.2.15.4 Trending The Director - Nuclear Assurance has established a trending and analysis 18 program to detect generic problems, adverse quality trends and repetitive 5 conditions. This program includes the review of documented conditions adverse to quality and significant conditions adverse to quality at a minimum. The specific documents included in the trending and analysis program are identified and distributed in accordance with implementing 9 procedures. 5 9
17.2-43 REV 19 5/95
' Docket Number 50-346 m==>
Attachment 1-INFORMATION ONLY Page 4 D-B 17.2.16 CORRECTIVE ACTION 17.2.16".1 General Procedures have been established to ensure that significant conditions adverse to quality are promptly identified, documented, evaluated for their significance, and corrected. These procedures require that the completed carrective action be documented and verified, and that the condition be r: ported 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
Fcr significant conditions, the cause is determined and corrective action to preclude repetition identified, and the status is tracked until correc-tive action is complete and verified.
Corrective action documents contain provisions for identifying the root
, c=se of the condition adverse to quality, the recommended corrective -
I cction, and the corrective action taken to prevent recurrence, in addition
, to the Nuclear Assurance Department's documented concurrence of the adequacy 18 cf the corrective action. The Nuclear Assurance Department also has the final review of all corrective action documents for closecut. 5 Thz quality assurance requirements in procurement documents or contracts rsquire the supplier or contractor not only to identify material or parts that do not conform to the procurement requirements, but also to determine end correct the causes for the condition adverse to quality. When suppliers furnish items that do not conform to procurement requirements, the 7 n:nconformance is documented and evaluated for further action. The actions !
, v2ry depending on the nature of the nonconformance and the supplier's quality history and may involve obtaining supplier corrective action or 1
j supplier reevaluation as a prerequisite for future procurement activities I with the supplier.
l
, 17.2.16.2 Significant Conditions Adverse to Quality l l
1 Conditions adverse to quality are considered significant when any of the following conditions exists
- c. The condition requires immediate notification to the NRC in accor-dance with 10CFR50.72. 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 j implementation, such that the design does not conform to the criteria l and basis stated in the Updated Safety Analysis Report (USAR). i 17.2-44 REV 18 11/93
Docket Number 50-346
[
. License Number NPF-3
) ' Serial Number 2364
- Attachment 1 Page 5 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, or to otherwise establish the adequacy of the structure, system, or component to perform its intended safety function is discovered.
- e. A closed commitment to an outside agency has not been implemented as required.
- f. A repetitive or adverse trend exists.
- g. Failure to resolve a deficiency in a timely manner or any condition 5
. determined to be significant by the Director - Nuclear Assurance such 18
' as the existence of a repetitive or adverse trend. 5 Significant conditions adverse to quality are documented and reported to 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 review or audit to verify the adequacy of the corrective action. 5 17.2.16.3 Tracking and Resolution 5
Implementing procedures define the methods employed for tracking and resolving corrective action documents. The responsible Department has the 8 responsibility to track the status of conditions adverse to quality until 5 the implementation of the corrective action has been completed and to assure that adequate resources are applied to close out the conditions adverse to g ua_lity in a timely manner.
(1h05E 1 4 >
1 . . QUALITY ASSURANCE RECORDS 17.2.17.1 General Per*inent documentation classified as Quality Assurance Records such as design, procurement, fabrication, inspection, nonccaformances and corrective action, tests, audits, and construction reports; document 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 operating logs; maintenance and modification procedures; reportable 5 occurrences; and other records as required by the Technical Specification are retained and available for review.
A Nuclear Records Management Program, as defined in approved implementing '
l procedures, identifies these records in the nuclear records list. This 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 ,
1 l
1 i
17.2-45 REV 18 11/93
, . . _ - _ . . - _ . ...-_.___._..._______...m_ __ _ . - _ . . - . . _. _.. _ _. . . . , .
Docket Number 56-346 .
, , License Number NPF-3 l Serial Number'2364-
-. ~ Attachment-1 Page 6 INSERT "A" {
[ Add the following to Section 17.2.16.3, Tracking and Resolution]_
,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-. j f
for significant conditions. The responsible Depar tment is also required to respond as requested by the correctiv _______ 2 ,,_2,__ ..
j m 3_z- w- -
y-------_--..g,~
,o 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.
u p -s -
17.2.18.7 Resolution of Audit and Surveillance Findinos 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 17.2.16.3.
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 responsibilities for resolution of identified nonconforming conditions are transferred to management of the audited organization.
\
17.2-50 REV 9 7/89
D-B Tablo 17.2-1 (enneina)
APPLICAi!1E ISC IEULEFJ GUIIES. ANSI STMDES, MD DOUST1T N . .
ISC REGIAIGT GJIIE.
I!n!s11U m ANSI STMDJtDS DAVIS-BESSE POSITION l14 .
B. Sectim 1.2 the "the adninistrative 'o > cn 't* t)
+
- 4. ANSI /ANS 3.2 (cme 4=M) cmtrols and ity Assurance provisions of $QS n0 1 be e p. r. m x the standard important plant i==applied e at atolevel other o or o e cr==tsurate with'thir of the p t g{Hg" to reliable and effic Imst operation. .
mz scZ 2
In lieu of this ,the ts 14 of this standard as discussed above and to I to ted itsmas Listed ites.
"$E g m 8-The applie=hility to AQ c sified itens armi nmM to those activitles that can affect the quality M ,
or safe operatim of these itses is accomplished . U$ z $ .
in a graded numer. cn *u i smw C. Sectim 2.2 - In lieu of the definitim of i" a m" in this standard Davis-Besse
- Inspect' l14 cr==tte to the definitim of ,n==e*4r=
s as dellreated in ANSI N45.2.10.1973.
D. Sectim 3.4.3 requires that persomel qualified in the tectnical areas indi- 5 cated be caphie of respandirig within two hours tor the purpose of providing tednical advice to tra Shift S@ervisor m a 24 hr.-a-day basis. In lieu of t
the specified two hour respmse tisurrespmse times delineated in the Devls he Besse lhergpncy Plan shall be utiliaod.
T,sQ g f Sect' ion 5.2.1.6 - In lieu of the require- 16 p* samts sitich limit the scheduled work time of the required shift cmplemurtt of licensed operators and sertior gerators aid the shift .
tar 4=ie=1 adviser. Davis-Besse cammits to the rapirements as delinanted in Davis-Besse thaclear Power Station thit 1 Tectnical Specificatims. Sectim 6.0.
FEV 16 7/92 g 17.2-54
b INSERT "B" ~
Add new Position 17.2-1.4.E:
" Sections 4.2.10 and 4.2.11 of: ANSI /ANS 3.2 require 'I N E)I Eb that written programs for both independent audits $ E ILS Si and reviews contain provisions to:
- F ES
- Assure timely response to review and audit "'d ~
- z findings by the subject organization, and R ES
- Require notification of appropriate management if '
- g. , h.7 agreed to follow-up action resulting from a "$"
review or audit is not implemented within the
, 3gg agreed to time period. os m i - -
In satisfying the intent of these requirements, all "7$" * '
audit findings shall be documented and processed in accordance with the existing Corrective Action program which shall require:
- Responsible management of the audited organization to review and investigate documented conditions adverse to quality to determine and schedule appropriate corrective action, including action to prevent recurrence for significant conditions.
- Responsible management to respond as. requested by the corrective action document giving results of the review and investigation, including root cause determination if required.
- Responsible management's response to state the corrective action taken or planned, including actions taken to prevent recurrence, if required. l In addition, the Audit program shall require periodic audits of the Corrective Action program:
- To 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).
- To verify implementation of completed corrective '
actions to previously identified audit findings which require audit follow-up."
D-3 Tabla 17.2-1 (Continued)
APPLICA$LE NRC PICULATORY CUIDES, AMST STANDARCS. MD IMDUSTRY CODES NRC REGULATORY GUIDE, IICUSTRY COCES ANSI STMCARCS TOLEDO EDISON POSITION V
- 4. ANSI /ANS 3.2 (Continued) f. Section S.2.2 requires that temporary changes wtick clearly do not change a *T3 >* fft t3 -
l16 Os rt m P- O g* the latent of the approved procedure, shall at a mialaus be approved by Q ft M O O~
two members of the plant staff knowledgeable is the areas affected by the procedere. At least one of these shall be a mammer of plant supervision. O${h[
H y H t/3 ft For changes to procedures which may affect the operational statue of plant MS O systems cc equipment, the changes shall be approved by two memDers of the plant supervision, at least one of whom holds a senior operators license on h D , *'*
ry the unit affected. In lieu of these requirements, Toledo Edisce commits to v (7" the requirement delineated in the Davis-Besse Nuclear power Statica Unit & WO O Technical Specifications, Appendix & to License No. NPF-3, Section 6.0 q y
Paragraph 6.S.3.1.b. M tFt WZO Section 5.2.15 requires that " Plant procedures shall be reviewed by aa indi- 16 .
g* vidual knowledgeable la the area af fected by the procedure no less frequent. a h ly than every two years to determine if changes are necessary or desirable. W&
This requireemat for routine follow.ap review, can be accomplished in several ways, incloding (but not necessarily lialted to): documented step-by-step use of the procedure (such as occurs when the procedere has a step-by-atop checkof f associated with it), or detailed scrutiny of the procedure as part of a docu-seated training progras, drill, slaulator exercise, or other such activity. A revistos of a procedure constitutes a procedure review.* In lies of these re.
quirements, Davis-Besse has many existing programmatic controls, which identify the necessity for procedure alternations to ensure that procedures are appropri-ate for the circumstance and are malatained current. Changes to prTedures are identified through the following processess plant modification; condition adverse to quality reporttag and management corrective action; test control; conduct of operations and maintenance control; control of Udpated Safety Analysis Report (USAR) changes, vendor manual control; operettag emperience assessment; Operating License Amendment; commitment management; destga specification changes; control of procedure changes; Quality Assurance
- audits and surveillance; setpoint control and document change request. Additionally, Davis-Besse performs an amasal Quality Assurance surveillance of randomly selected plant procedures. The surveillance will provide added assurance that' existing programmatic controle provide for timely revision of procedures.
17.2-54a REV 16 7/92 v
D-B Table 17.2-1 (Continued)
APPLICABLZ NO REIAIEtRY GJIIES, ANSI STMOWDS, MO DUJSTIE CIES .
NC PH11ATCET GJIIE, DELIST!Of (EG3 #EI STMOMtts DWIS-BESSE POSITICH l14 l14 yyyMg
-15. Pegulatory Guide 1.123 cmtimed B. Sectim 10.2.d of MtSI N45.2.,13 is $ $O 1S SDS O-inte as fo11ous the pers m a to a certificate shall be 5 C["$"
m2 2 an armi ible esplayee Z of the st9 plier and be identi- % N fled by tne supplier. s &
Oulde 1.144, ANSI N45.2.12-1977 Re- 1. Davis-Besse ccanits to the regulatory l14 "@"
u m
- 17. Regula for hxilting positicn of this gpide. wZo Rev. 1 80 " Auditing of 5-ty Assurance Pro ear Power Plants" gram for r surance Program lear Power Flants".
2@O i a w*
- 2. Davis-Besse cannits to the ts I14 of this standard with the fo clari-ficatim 5
A. Sectim 2 of ANSI N45.2.12 provides requirments for the training and gualificatim of =ditirw personnel.
in lieu of this requirmint Davis- 14 Besse shall quality its atailtors in accordsoce with the requirments of 5 Regulatory Guide 1.146.
_L tJ5El'YC
~17.2-n - REV 14 7/91
=
- - - - - - - - - - - - - - _ - ____m_ _ _ _ _ _ _ _ _ _ _ _ , _ _ _ ,
INSERT 'C' --
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 g g gI2 g adverse audit findings and identified quality g g Q g p.
assurance program deficiencies on a timely basis. oaoe In lieu of these requirements, the Corrective $ ![ *" $ "
Action and Audit programs shall contain provisions @ q z g*
for the actions outlined in Position 17.2-1.4.E." "& &
"$e$
Add Position 17.2-1.17.2.C: u " u,
" Sections 4.3.2.4 and 4.3.2.5 of ANSI N45.2.12 g$?
require that when a nonconformance or quality *?"
assurance program deficiency is identified as a wm 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 lieu 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.D:
"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 l
- The audited organization provide a follow-up
, report stating the corrective action taken and the date corrective action was completed.
l In lieu of these requirements, the Corrective Action and Audit programs shall contain provisions for the actions outlined in Position 17.2-1.4.E."
1
m v rie g
$ N $ EIn !
- 8 Br 8 2' INSERT "C" (cont'd)
G[~2" n *z% .
Q .
Add position 17.2-1.17.2.E: ~"ngn'
. "Section 4.5.2 of ANSI N45.2.12 requires that, when g" y,
> necessary, follow-up actions for audit findings be wm? _
amw.
performed by the audit team leader or management of the auditing organization through communication, O$.
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 i identifies and schedules corrective action for each audit finding, and f
- Confirm management of the audited organization i accomplishes corrective action to audit findings as scheduled."
l In lieu of these requirements, the Corrective Action and Audit programs shall contain provisions for the actions outlined in Position 17.2-1.4.E."
- n -
I t
Docket Number 50-346
.Lidense Number NPF-3 Serial Number 2364
- Attachment 2 Page 1 1
ATTACHMENT 2 DAVIS-BESSE NUCLEAR POWER STATION EVALUATION
- OF PROPOSED QUALITY ASSURANCE PROGRAM REDUCTIONS
Docket Number 50-346
. , License Number NPF-3 Serial Number 2364
. Attachment 2 Page 2
.J 3
1CCFR50.54 EVALUATION FOR UCN 95-033U
- (EVALUATION OF PROPOSED QUALITY ASSURANCE PROGRAM REDUCTIONS)
PROPOSED CHANGES The proposed changes to the Updated Safety Analysis Report (USAR)
Chapter 17.2, Nuclear Quality Assurance Program Description, are shown '
^
on the marked-up pages of Sections 17.2.16.3, 17.2.18.5, and 17.2.18.6 and Table 17.2-1.
The proposed changes are intended to:
. Eliminate " thirty days' as a prescribed time limit for completion of audit finding responses and required corrective actions,
. Eliminate " root cause determination" and " action to prevent recurrence" as prescribed audit finding actions (except for i significant conditions),
. Eliminate Nuclear Assurance / Quality Assessment (also known as
" Quality Auditing") in-line responsibilities for audit finding corrective action and verification, and
. Separate audit and surveillance activity completion from closure of associated audit / surveillance-identified deficiencies.
I. CORRECTIVE ACTION REPORTING, INVESTIGATION, CLOSE-0UT, AND I
FOLLOW-UP Ia) 17.2.16.3, Page 17.2-45: Add to Section 17.2.16.3 as shown in i Insert A: "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 state the corrective action taken or planned, including actions taken to prevent recurrence, if required."
i 4
4 i
Docket Number 50-346
, License Number NPF-3 Serial Number 2364 Attachment 2 Page 3 Ib) 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."
Ic) 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."
Id) 17.2.18.6, Page 17.2-49: Remove: "Upon notification the remedial /
corrective action to prevent recurrence has been completed, appropriate follow-up measures such as reading is used to confirm that these actions have been satisfactorily accomplished."
Ie) Page 17.2-50: Add new Section 17.2.18.7 as shown:
" 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 17.2.16.3."
If) 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 and reviews contain provisions to:
- Assure timely response to review and j audit findings by the subject 1 organization, and
- 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. i i
l Docket Number 50-346 i
, License Number NPF-3 l Serial Number 2364
. Attachment 2 l Page 4 l
If) Table 17.2-1: Add new Position 17.2-1.4.E: (cont'd.)
In satisfying the intent of these requirements, all audit findings _shall be documented and processed in accordance with the existing corrective Action program which shall require:
- Responsible management of the audited !
organization to review and investigate !'
documented conditions adverse to quality to determine and schedule appropriate corrective action, including action to prevent recurrence ;
for significant conditions.
- Responsible management to respond as requested by the corrective action document giving results of the review ,
and investigation, including root cause determination if required. ;
- Responsible management's response to state the corrective action taken or planned,. including actions taken to prevent recurrence if required. j t
In addition, the Audit program shall
- require periodic audits of the Corrective Action program:
- To 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).
- To verify implementation of completed corrective actions to previously identified audit findings which require audit follow-up."
Ig) 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 lieu of these requirements, the Corrective Action and Audit programs shall contain
- provisions for the actions outlined in Position 17.2-1.4.E."
4
Docket Number 50-346 License Number NPF-3
' Serial Number 2364
. Attachment 2 Page 5 Ih) 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
- 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 lieu of these requirements, the Corrective Action and Audit programs shall contain provisions for the actions outlined in Position 17.2-1.4 E."
Ii) Table 17.2-1: Add Position 17.2-1.17.2.D as shown in Insert C: "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 lieu of these requirements, the Corrective Action and Audit programs shall contain provisions for the actions outlined in Position 17.2-1.4.E."
Ij) 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 performed by the audit team leader or management of the auditing organization 1 through communication, re-audit, or other appropriate means to:
Docket Number 50-346 License Number NPF-3 Serial Number 2364
. Attachment 2 Page 6
- 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 lieu of these requirements, the Corrective Action and Audit programs shall contain provisions for the actions outlined in Position 17.2-1.4.E."
II. AUDIT AND SURVEILLANCE ACTIVITY COMPLETION iia) 17.2.18.6, Page 17.2-50: Remove: "An audit is considered closed on the date when all audit findings have been verified and closed."
4 iib) Page 17.2-50: Add new Section 17.2.18.8 as shown:
"Close-out of Audits and Surveillances -
Audits and Surveillances can be considered closed after the audit report 4 or surveillance report is issued and responsibilities for resolution of identified non-conforming conditions are transferred to management of the audited organization."
REASON FOR AND EFFECT OF CHANGES As shown in Changes Ia-Ij, the existing Audit program reliance on prescribed time limits, corrective action levels, and in-line Quality Assessment follow-up for audit finding corrective actions will be modified to make line management accountable for assuring timely and thorough corrective action under the Corrective Action Program. Technical Specification 6.5.2.8.c, USAR 17.2.16.2, and USAR 17.2.18.3.e will appropriately 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.
_ . . . . _ _ _ . . __ . _ _ . ~ . _ . . _ _
Docket Number 50-346 License Number NPF-3 Serial Number 2364
- Attachment 2 Page 7 As shown in Changes iia and iib, the existing requirements for audit / surveillance packages to remain open until all identified 1
findings are resolved will be modified to allow closure of audits and surveillances after the applicable report is issued and responsibilities for non-conforming conditions are transferred to line management. Resolution and closure of associated findings will be by responsible management, rather than by Quality Auditing, and will be
, independent of the audit and surveillance processes.
Elimination of these in-line responsibilities will allow more effective allocation of Quality Auditing resources to selected activities considered more significant.
BASIS FOR CONCLUSION THAT REDUCTIONS CONTINUE TO SATISFY 10CFR50 APPENDIX B i
While the changes are considered to be reductions to existing commitments, the requirements of the associated 10CFR50 Appendix B I "Nonconformances", " Corrective Action", and " Audits" criteria will not be affected by the proposed changes. All systematic 10CFR50 Appendix B nonconformance, corrective action, and audit programmatic
+ requirements will continue to be satisfied by DBNPS's Nuclear Quality
, Assurance Program.
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