ML20098D993

Change Notice 90-10 to Callaway Plant Operating QA Manual

ML20098D993
Person / Time
Site:	Callaway
Issue date:	06/30/1991
From:	UNION ELECTRIC CO.
To:
Shared Package
ML20098D876	List: ML20098D875 ML20098D993
References
NUDOCS 9206010164
Download: ML20098D993 (16)

Text

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ATTACHHENT 1

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OQAM, CN 90-10 IDENTIFICATION OF CHANGES 4

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9206010164 920515

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i OQAM LN W"M l 1

l 16.0 CORRECTIVE ACTION 324 Measures shall be established to assure that condi l 1870 141 tions adverse to quality are promptly identified, 1903 reported, and corrected. Nonconformances shall b 2978 controlled in accordance with the requirer nto described in Section 15. Each of the Nuclear ivi-ion Managers is responsible for developi and i plementing a program for identifying and c ntrol-lih,g adverse conditions. This responsibili may be s

satisfied by one or more programs. As minimum each' program shall provide for developing and anal-yzing (trends on a semiannual basis. Ttending of conditions adverse to quality identified at suppli- .

er's facilities is performed as part of the annual supplier ' evaluation per 00AM, Section 18.12. Proce-dures shall provide instructions for identifying, reporting, 'and initiating corrective action to l preclude recurrence of adverse conditions. It is understood that the term " corrective action" includes remedial action necessary to correct tne deficiency, as well as corrective action necessary to preclude recurrence. /

IJ.2 Conditions adverse \to qua ity which impede the implementation or reduce the effectiveness of the l

operating QA Program \shyll be controlled by the measures described her'ain. Adverse conditions may include, but are not limlted to, noncompliance with procedural requirements;N reportable occarrences required by regulat 'ons; adverse nonconformance trends: deficiencies identified in the OQAP; recur-ring conditions f r which past corrective action has been ineffecti'"e; or breakdowns in administra-tive and manage /ial control systems which could l

result in a syst'em designed to prevent or mitigate serious events / not being able to perform its intended functi'on.

16.3 Corrective action documents which record defects in .

deviations from l

basic comjonents or technical tequirements in procurement documents shall be reviewed /for reporting applicability under 10CFR21 and other Federal reporting requirements.

3599 16.4 Corrective action documents shall be transmitted 3600 to the responsible organization. The responsible organization shall investigate the findings and identify the cause(s) of the deficiency, and l

I specify and initiate the action (s) necessary to correct the conditions and prevent recurrence.

16-1 Rev. 14 1 6/91

OOAn vM <ro -10 16.5 clear Engineering shall review documented condir t ns adverse to quality which involve design def '- '

cies or design changes which are recommended as ci cor ctive action. Licensing and Fuels sh uld j rovi documented conditions adverse to quallt for fuel- lated issues. The ORC shall review a nifi-cant a verse conditions. Examples of such condi-tions i clude those identified by Callaw4? Plant Technical Specifications 6.5.1.6(f), 6y$.1.6(g),

6.5.1.6(h) 6 .5.1.6(1), and 6e5.1.6(m); knd NPDES violations.\

16.6 Corrective action documents shall be closed by verifying the implementation and adequacy of corrective action. The Quality Assurance Department shall close OA-originated corrective action docu-ments. by verifying the implementation and adequacy of corrective action. Copies of completed correc-tive action- documents shall be available for management review (hardcopy or electronic media) to keep them apprised of conditions adverse to qual-ity. The Quality Assurance Department shall period-ically prepare summaries of significant corrective action documents and submit them to the NSRB and appropriate levels of management.

16.7 The closure of corrective action documents shall be accomplished as promptly as practicable but shall occur only after the corrective action taken has been verified. . Verification may- be accomplished through direct observations, written communica-tions, re-audit / surveillances, or other appro-priate means. The nature of the deficiency may be such that remedial actions need to be taken imme-diately whereas development and implementation of corrective action to preclude recurrence may take substantially longer.

16.6 Summaries. of corrective action documents'shall be reviewed for the off :1veness of the corrective actions taken and ar.alyzed for potential adverse '

quality- trends. Quality Asrurance shall evaluate the analyses, the identification of adverse trends, and the acceptability of actions taken on these trends through routine audit and surveillance activities; and shall report the results of thehe l assessments to management.

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16-2 Rev. 14 6/91

. OQAM CN 90-10 16.0 CORRECTIVE ACTION 1870 16.1 Measures shall be established to assure that conditions 1903 adverse to quality are promptly identified, reported, and 2978 corrected. Such measures shall be established in a program or programs which are proceduralized. Those procedures, as a minimum, shall

1. Define responsibilities for identifying and correcting conditions adverse to quality. Such corrections may be defined as remedial action.

2. Defina responsibility for verifying that remedial actica was taken for conditions adverse to quality.

. 3. Define responsibilities for determination _of those conditions adverse to quality which are significant.

Significant conditione adverse to quality will require both remedial action and action to prevent recurrence.

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4. Define responsibility for performing root cause evaluation, deternining necessary actions to prevent recurrence, implementing those actions and verifying completion of those actions for significant conditions adverse to quality.

5. Provide a method for documon't.ing the identification of conditions adverso tc Juality. This documentation shall also include the root cause or causes and the action implemented to prevent recurrence for significant conditions adverse to quality.

6. Provide methods for reporting significant conditions adverse to quality to appropriate levels of management. Acceptable methods include direct addrese, distribution of copics, electronic access or review of summaries of the conditions. These methods shall include reporting of significant conditions adverse to quality to review committees.

7. Provide methods for submitting reports required by external agencies concerning conditions adverse to quality.

1800 8. Provide for developing and analyzing trends on at least a semiannual basis. Trending of conditions adverse to quality identified at supplier's facilities is performed as part of the annual supplier evaluation per OQAM, Section 18.12.

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, OQAM CH 90-10 E16.2 Conditions adverse to quality which are classified as nonconformances shall be controlled in accordance with the additional requirements described in OQAM, Section 15.

16.3 Conditions adverse to quality which impedo the implorentation or reduce the effectivenosa of the Operating QA Program shall be considered significant conditions adverse to quality. Significant conditions adverse to quality may include, but are not limited to, noncompliance with procedural requirements which impact nuclear or personnel safety; reportable occurrences required by regulations; adverse nonconformance trends; deficiencies identified in the OQAp; recurring conditions  :

for which past corrective action has been ineffective; or breakdowns in admir.istrative and managerial control systems which could result in a system designed to prevent or mitigate serious events not being able to perform its intended function. Some examples of such conditions include those which match the descriptions in Callaway Plant Technical Specification 6.5.1.6f, g,h, 1, m (potential hazards to nuclear safety) and NPDES violctions..

16.4 Conditions adverse to quality which involve defects in basic components or deviations from technical requirements in procurement documents shall be reviewed for reporting applicability under 10CFR21 and other Federal, reporting requirements. Reportable conditions adverse to quality are classified as significant.

16.5 The nature of the condition adverse to quality may be such that remedial actions need to be.taken immediately, whereas development and implementation of correct!ve action to preclude recurrence may take substantially longer.

16.6 Nuclear Engineering personnel shall review conditions adverse to quality which involve dec.lgn deficiencies or which involve recommending design changes as corrective action. Licensing and Fuels should review conditions t

ady?rse to quality for fuel-related issues. The ORC shall review significant conditions-adverse to quslity.

16.7 Corrective action documents shall be closed by verifying the implementation and' adequacy of corrective action. The l closure of. corrective action-documents-shall be accomplished as promptly as practicable but shall occur only after-the corrective action taken-has been verified.

Verification may be accomplished through direct observations, written communications, re-audit, surveillances, or other appropriate means.

, OQAM CH 90-10 16.8 cc les of completed corrective action documents shall be available for management review (hardcopy or electronic media) to keep them apprised of conditions adverse to quality. The Quality Assurance Department shall periodically review corrective action documents and identify significant conditions. Summaries of significant conditions adverse to quality shall be submitted to the NSRB and appropriate levels of management.

1800 16.9 Corrective action documents shall be reviewed for the effectiveness of the corrective actions taken and analyzed for potential adverse quality trends. Quality Assurance shall evaluate the analyses, the identification of adverse trends, and the acceptability of actions taken on these trerids through routine audit and surveillance activities; and shall report the results of these assessments to management.

OQAM APPENDIX A g(/ M (N W 'd l REGULATORY GUIDE 1.144 (cont.)

With regard to Section 2.3 (and subsections 2.3.1 through 2.3.3) of ANSI N45.2.12 - 1977 titled Training: The training of UE audit personnel shall be accomplished as described to meet the require-ments of Regulatory Guide 1.14G (ANSI N45.2.23 - 1978) an endorsed in this Appendix and OQAM Section 18.

With regard to Section 2 4 of ANSI N45.2.12 - 1977 titled Mainte-nance of Proficiency: The maintenance of proficiency of UE audit personnel shall be accomplished as described to meet the require-ments of Regulatory Guide 1.146 (ANSI N45.2.23 - 1978) as endorsed in this Appendix and OQAM Section 18.

With regard to Section 3.3 of ANSI N45.2.12 - 1977 titled Essen-tial Elements of the Audit System: UL' shall comply with subsec-tion 3.3.5 as it was originally written (subsection 3.2.5) in ANSI N45.2.12, Draft 3, Revision 4: " Provisions for reporting on the effectiveness of the Quality Assurance Program to the respon-sible management." For the auditing organization (UE), effective-nesa shall be reported as required by the Callevay Plant Tech-nical Specifications. Other than audit reporta, UE may not directly report on the effectiveness of the quality assurance programs to the audited organization when such organizations are outside of UE.

Subsection 3.3.6 requirements are considered to be fulfilled by compliance with the orgnnization and reporting measures outlined

! in this Operating QA Manual and the Callaway Plant Technical Specifications. In every case either identical or equivalent controls are provided in the sections of the referenced docu-ments.

Subnection 3. 3.7 requires verification of effective corrective action on a ' timely basis.' T4mSI-y- ba s is-4s- i n t e r p r e t ed - t c -mean notAT >within- the- f ramework-or-period-of-t-ime for completion oF correc-rP* b4ve--action-that-is-accepted by the Quality Assurance Department 966 or - Quality-Services-Department, Each finding requires a response 3 .bo(v and-a-cor rective action-complet4on-4 ate-; these dates are subject t o---r e v i si on-( w ith-t h e-a pp rova l-o f-t he-Qu a l i t y- A s s u r a nce--Depa rt -

ment-or-Quality Services-Department }-and-munt- be -escalated to h i g h e r--a u t ho r4 t y-w he n-the r-e-4 s-a-d i-sa g reeme n t-be t wee n --th e-eu d it ed and-t he-aud i t4 ng-o-rg a n i sa t4on s--on-wha t const4tatec " t4rie-ly cor rective-action."

With- regard to Section 3.4 of ANS7 N45.2.12-1977 titled Audit Planning: Identical or equivalent' controls are provided in this OQAM, Section 18.

A-30 Rev. 14 6/91

. OQAM CN 90-10 IMERT Verification of the implementation of corrective action is performed as indicated in Section 16 of this OQAM. Corrective action program effectiveness is determined through audit or surveillance as described in Section 18 of this COAM, using previously issued corrective action documents as input to the scope of audits and surveillances. Additionally, trending of corrective action documents will be used to reveal potentially ineffective corrective actions and the effectiveness of the corrective action program.

Page A-30a

OQAM APPENDIX A M # D' REGULATORY GUIDE 1.144 (cont.)

(c) Audit reports may not necessarily contain an evaluation statement regarding the effectiveness of the Quality Assu-rance Program elements which were audited, as required by l subsection 4.4.4, but they ahall provide a summary of the audited areas and the results which identify the importance of any adverse findings.

With regsrd to Section 4.5.1 of ANSI N45.2.12 - 10*/7 titled JB Audited Organization: UE shall comply with the following clarifi-cation of the Section: Manag eme n t-o f-t he-aud i ted-orga n4 ea t4o r mSEW_* activity shall review and investigate adverse audit finding as FA'*. necessary, (e.g. where the cause is not already known, j other has not already investigated and found p e cause, AO ](

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organization etc.) to determine and schedule appropriate coct orive action including action to prevent tecurrence. They a clearly state the corrective action taken or planned to prey t recurrence and the results of the investigation, if conducJe'd. In the event that corrective action is not completed )w din thirty days, the audited organization's response sh date for completion of planned correctJV'gli includeThe e action. a scheduled audited organi-zation shall take appropriatefacticn to assure that corrective action is accomplished as schd8uled. Since the audit.ing organiza-tion tracks scheduled ydrrective action completion dates and verifies corrective jdion completion, a follow-up response by the audited organiz6 tion stating the corrective action taken and the date that the' action was completed is not necessary, provided corrective go-dons are completed as specified. If corrective actions ard not completed as specified, the audited organization shall p a ravised response stating the corrective Action

! tha) ' bas (ovide the corrective action y=P to be completed, been taken, 4ad tha date-that-aL1-cor-rect 4we-act-lon-wi-1-1-bt-completed.

REGULATORY GUIDE 1.14C INITIAL ISSUE DATED 8/80 Qualification of Quality Assurance Program Audit Personnel for i Nuclear Power Plants (Endorses ANSI N45.2.23-1978) l DISCUSSION:

UE complies with the recommendations of this Regulatory Guide l

with the following clarifications:

l With respect to Section 1.4 of ANSI N45.2.23-1978 titled Defini-l tions: Definitions in this Standard which are not included in l ANSI N45.2.10 shall be used: " Audit" which is' included in this l Standard and ANSI N45.2.10 shall be used as clarified in this l Appendix under Regulatory Guide 1.74.

A-33 Rev. 14 6/91

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4 OQAM CN 90-10 INSERT Management cf the audited organization or activity shall review and investigate adverse audit findings, as necessary, (e.g. where the cause is not already kncvn, another organization has not already investigated and found the cause, etc.) to determine and schedule apprapriato remedial action. The audited organization shall assur6 documentation of remedia) action taken is provided.

Adverse audit findings shall be evaluated to determine the need for action to prevent recurrence. If such action is deemed necessary, the results of the investigation (root cause analysis), the corrective action taken or planned to prevent recurrence, and a schedule for implementation shall be provided by the audited organization. Such evaluations and implementation of actions shall be scheduled and performed consistent with the safety significance of the item. The audited organization shall take appropriate action to assure corrective action is accomplished an scheduled. In the event the action or schedule of implementation must be changed, the audited organization shall provide a revised response on or before the originally scheduled completion date stating the corrective action which has been taken, the corrective action yet to be completed, and the date that all corrective action will be completed. Evaluation progress and corrective action implementation will be performed in accordance with provisions of Section 16 of the Union Electric Operating Quality Assurance Manual and will be tracked.

With regard to Section 4.5.2 of ANSI N45.2.12-1977 titled By A Auditins j:: ganization: UE shall comply with the following m

clarifice._on of the section: For-internal audits, performed by or for the Quality Assurance Department, follow-up actions will be taken by the audited organization as described in Section 16 l

of this OQ2M. The internal audit program implemented in Section 18 of this OQAM provides assurance tn6t the corrective action program requirements are properly implemented. By sampling responses to conditions adverse to quality, the adequacy of root cause analysis and implementation of remedial action and action to prevent recurrence is verified to assure effective corrective action program implementation. Therefore, the auditing organization will not necessarily evaluate the adequacy and assure action is identified and accomplished for each adverse finding. For external audits sections 4.5.2 of ANSI N45.2.12-1977 shall be complied with as written.

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ATTACHHENT 2

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OQAM, CN 90-10 EXPLANATIONS OF AND JUSTIFICATIONS FOR PROPOSED CHANGES TO'THE OQAM

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. Attachment 2 ULNRC-2630 Page 2 of 6 EXPLANATIONS OF AND JUSTIF.*4ATIONS FOR PROPOSED CHANGE TO THE OPERATING QUALITY ASSURANCE MANUAL (OQAM)

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1) Justification for clarification of Section 16 of the OQAM.

Section 16 has been rewritten to clarify the sections and reorder them to make the sections more user friendly.

Additionally, the requirement to have the Quality Assurance (QA) Department close QA originated internal corrective action documents has been deleted. Implementing procedures currently require the management, of the group (s) required to take action to address conditions adverse to quality, verify the implementation of remedial action and action to prevent recurrence prior to closing the corrective action document. QA verification is not done until after the appropriate management has performed their verification and is thus redundant. QA has and will continue to verify, through the normal audit and surveillance process described in Chapter 18 of this oQAM, the effectiveness of management's verification. Requiring an additional verification of action implementation based on who originated the corrective action document is unnecessary.

Additionally, since some conditions' adverse to quality identified by QA are not "pignificant", imposing the additional verification activity may detract from the assessments of more significant areas. Currently the QA department expends approximately "/00 man-hours per year evaluating and verifying these less significant conditions

adverse to quality. This change would allow those man-hours I to be redirected to other assessment activities. A specific.

use may include verification of the adequacy of response and action implementation for a larger sample of conditions cdverse to quality identified by other plant personnel. This revision is a lossening of our previous quality progran commitment, however, it will not result in a lessening of the overall effectiveness of the Operating Quality Assurance Program. The OQAM continues to meet 10CFR50, Appendix B.

Conditions adverse to quality, identified during audits or surveillances of suppliers, will continue to be evaluated, accepted, and verified by QA personnel. This is done in accordance with procedures which implement the provisions of Chapter 16 of this OQAM. This clarification and revision of Chapter 16 will regelre no revision to our practices for conditions adverse to quality identified relative to suppliers.

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. Attachment 2 ULNRC-2630 Page 3 of 6

2) Justification for changes to clarification to Section 3.3.7 of ANSI N45.2.12-1977:

This section needs to be revised to eliminate the QA acceptance and approval of initial responses and completion date revisions for QA originated conditions adverse to quality. The basis for this change is explained in Justification 1, for revision to Char ter 16 of this 02AM.

Since QA is no longer interpreting timeliness based on corrective action schedule acceptance, no further clarification to Section 3.3.7 of ANSI N45.2.12-1977 is needed, our previous clarification also referred to escalation due to disagreements regarding timeliness of corrective action. Measures for resolution of disagreements, including those over corrective action and scheduled implementation dates are addressed in this OQAM, Section 2.8 and thus do not need to he restated here. Verification of effectiveness of previous corrective actions is through the normal audit and surveillance process and trending of corrective action documents.

QA personnel will continue to review and approve responses to corrective action documents sont to suppliers.

Verification of the effectiveness of action on supplier issues is typically performed at the time of re-audit of the vendor per Sections 18.2 (scope) and 18.11 (frequency) of this OQAM. Additional clarification is not needed for this section of ANSI N45.2.12.

3) Justification for clarification to Section 4.5.1 of ANSI N45.2.12-1977:

This clarification more clearly defines UE's expectation for resolution of internal audit findings. Such findings are reported via a common corrective action system used by plant departments as well as QA. This system provides for the evaluation of conditions adverse to quality consistent with their significance. Significance is based on nuclear safety, radiological safety, industrial safety, and regulatory considerations; and other factors deemed prudent by management. In.using this system some audit findings will require remedial action only. The plant trending program as well as periodic re-cudit by-QA will indicate if further action is needed. Other audit findings will be of a significance to warrant remedial action, root cause-analysis, and specific action designed to prevent recurrence. Conditions adverse to quality identified by personnel other than QA will also be evaluated by appropriate management to fit one of.the above mentioned criteria. As such the QA identified issues do not need to be evaluated within an erbitrary time period, e.g. thirty days.

They will now be evaluated and resolved based on their significance.

Attachmunt 2 ULNRC-3630 Page 4 of 6 This clarification is consistent with provisions of Regulatory Guide 1.33 for corrective action programs at operating nuclear power plants as well as the UE Operating Quality Assurance Program requirements for corrective action. While the elimination of the 30 day response time for audit findings may be considered a lessenit.y of previous commitments, this change does not reduce the effectiveness of the quality assurance program nor its adherence to provisions contained in Appendix B of 10CFR50.

4) Justification for clarification to Section 4.5.2 of ANSI N45.2.12-1977 As stated in the justification for the clarification for Section 4.5.1 of this stanward, the auditing organization (QA for internal audits) reports findings via a common corrective action system used by both QA and plant departments. Implementation of the program described in Chapter 16 of the OQAM requires the generation of written responses to adverse findings, evaluation of the adequacy of '

responses, identification of corrective action, identification of action implementation schedules and confirmation of action accomplishment. As stated in the justification for the clarification of Chapter 16, verification of adequacy of response and implementation of action by QA is redundant to that required of management of the audited organization. Plant trending as well as periodic audit and surveillance will provide assurance that audited management performs their verifications effectively. This section needed to be changed to be consistent with other-

' changes proposed herein. Requirements for external audits do not need clarifications as those audit findingn do need to be evaluated fc- adequacy and implementation verified by the QA Department.

5) Pages 5 and 6 of this justification are simplified flow charts which clarify how the current consolidate 6 corrective action program is implemented by plant administrative procedures and how the changes proposed in this submittal would revise that program.

Union Electric considers this reduction to be justified and the OQAM to continue to meet the requirements of 10CFR50, Appendix B.

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