ML20091J319

Change Notice 90-10 to Rev 14 to Operating QA Manual

ML20091J319
Person / Time
Site:	Callaway
Issue date:	01/03/1992
From:	UNION ELECTRIC CO.
To:
Shared Package
ML20091J317	List: ML20091J315 ML20091J319
References
NUDOCS 9201100269
Download: ML20091J319 (14)

Text

_ - _ - - _ _ _ _ - _ - _ _ - _ - _ _ __

• t 9

A T T A C 11 M E N T 1

/////////////////////////////////////////////////////////////////////////////////////////////

OQAM, CN 90-10 IDENTIFICATION OF CHANGES ,

5 2

////////////////////////////////////////////////////////////////////////////////////'////////

9 201 ] OQ 2/;.? is20103 2 pgg ADOCV. 05000%_.7- PDn 1>

y

~ - . - - . , -

y=

- -- - ; oggg c d 9 7

}. ,

16.0 CORRFCTIVE ACTION 3 16.1 Measure 3'shall-be established to assure that condi-1870 tions adverse to quality are promptly identified, 1903 .

reported, and corrected. Nonconformances shall be 2978- controlled in- accordance with the requirements described in Section 15. Each of the' Nuclear Divi-sion Managers is responsible -for- developing and- ,

implementing-a program for identifying and control-  :

Lling adverse conditions.LThis responsibility may be tisfied by one or more: programs. As a minimum e 'h program shall provide for developing and anal-yzhg -trends. on a semiannual basis. Trending of cond'tions adverse to quality identified at suppli-er's facilities is performed as part of the annual

-suppli r evaluation per OQAM, Section 18.12. Proce- <

dures all provide instructions for identifying, 4 reporting and initiating corrective action to preclude ocurrence of adverse conditions. It is understood that the . term " corrective action"

-includes re edial action necessary to correct the deficiency, s well as corrective action necessary to-preclude te urrence.

16.2 Conditions -adve ce to quality which impede the implementation - os reduce the effectiveness of_ the Operating QA' Pro am-shall be controlled by the mensures described erein. Adverse conditions 1 may

. include, but are not imited to, noncompliance with procedurel requireme ts; reportable occurrences ,

required- by regulatio p; adverse nonconformance trends; deficiencies ided ified in the OQAP; recur-ring conditions for--whi past corrective _ action has been ineffective; or b eakdowns in administra-tive and managerial contro systems which could .

. result in=a system-designed o prevent.or mitigate serious _ events not being a e to- perform its-intended function. >

16.3 Corrective action documents which ecord defects in basic . components or- deviations rom -technical requirements in procurement. docum ts shall be C reviewed for reporting. applicability nder 10CFR21 and other Federal reporting requirement .

3599' 16.4 Corrective-action documents shall be tran itted 3600 to' the responsible organization. The res onsible organization _ shall investigate _the- findin s _and identify the- cause(s) of the deficiency, and specify and initiate the action (s) 'necessar to correct the conditions and prevent recurrence.

16-1 Rev. 14 6/91

OOAM CN #dd s

16 bp Nocjsar Engineering shall review documented condi-La m adverse to quality which involve design defi-

\ ciencies or design changes which are recommended as s corrective action. Licensing and Fuels should review documented conditions adverse to quclity for fbel-related issues. The ORC shall review signifi-

~l cast adverse conditions. Examples of such condi-tionq include those identified by Callaway Plant Techn1 cal Specifications 6.5.1.6(f), 6.5.1.6(g),

6 . 5 .1.' h), 6.5.1.6(1), and 6.5.1.6(m); and NPDES violati s.

16.6 Correctiv action documents shall be closed by verifying the implementation and adequacy of corrective a tion. The Quality Assurance Department shall close QA-originated corrective action docu-ments by veritying the implementation and adequacy of corrective Aption. Copies of completed correc-tive action documents shall be available for management review \(hardcopy or electronic media) to keep them appriseds of conditions adverse to qual-ity. The Quality Assyrance Department shall period-ically prepare summa les of significant corrective action documents aa submit them to the NSRB and appropriate levels of m nagement.

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

16.8 Summaries of corrective action docum nts shall be reviewed for the effectiveness of th corrective actions taken and analyzed for potent'al adverse quality trends. Quality Assurance shal evaluate the analyses, the identification of adver' e trends, and the acceptability of actions taken n these trends through routine audit and sur 1111ance activities; and shall report the results o these -

assessments to management, g

\

'\ s 16-2 Rev. 14 6/91

OQAM CN 90-10 1870 16.0 CORRECTIVE ACT19H 2978 t 1903 16.1 Measures shall be established to assure that conditions 3599 adverse to quality are promptly identified, reported, and 3600 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. Define responsibility for verifying that remedial action was taken for conditions adverse to quality.

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

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

4. Define responsibility for performing root cause evaluation, determining 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 documenting the identification of conditions adverse to quality. 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 address, distribution of copies, electronic access or review of summaries of the conditions. These methods shall include reporting of selected significant conditions adverse to quality to review committees.

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

8. Provide for developing and analyzing trends on 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.

l OQAM CN 90-10 i

16.2 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 impede the implementation or reduce the effectiveness of the operating QA Program shall be considered significant conditions adverse to quality. 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; adverso nonconformance trends; deficiencies identified in the OQAP; recurring conditions for which past corrective action has been ineffective; or breakdowns in administrative 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.

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.

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 corrective action to preclude recurrence may take substantially longer.

16.6 Regardless of the program used, Nuclear Engineerir.g personnel shall review all documented conditions adverse tc quality which involve design deficiencies or which involve recommending design changes as corrective action.

Licensing and Fuels should review documented conditions adverse to quality for fuel-related issues. The ORC shall review significant conditions adverse to quality.

Examples of such conditions include those identified by Callaway Plant Technical Specifications 6.5.1.6(f),

F 6.5.1.6(g), 6.5.1.6(h), 6.5.1.6(1), and 6. 5.1. 6 (m) ; and NPDES violations.

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

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

l l '

OQAM CN 90-10 t

16.8 Copies 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 identity significant conditions. Summaries of these conditions shall be submitted to the NSRB and appropriate levels of management.

324 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 taker on these trends through routine audit and surveillancc activities; and shall report the results of these assessments to management.

f d

' OQAM (. h sfJ - @

APPENDIX A h::GULATORY GU1DE l.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 1.146 (ANSI N45.2.23 - 1978) as 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 audic personnel shall be accomplished as described to m?et the require-ments of Regulatory Guide 1.146 (ANSI N45.2.23 - 1978) as endorsed in this Appendix and OQArt Section 18.

With regard to Section 3.3 of ANSI N45.2.12 - 1977 titled Essen-tial Slements of the Audit System: UC 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." FC: the auditing organization (UE), effective-ness shall be reported as required by the Callaway Plant Tech-nical Specifications. Other than audit reports, 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 organization and reporting measures outlined in this Operating QA Manual and the Callaway Plant Technical Specifications. In every case either dentical or equivalent controls are provided in the sections of the referenced docu-ments.

Subsection 3.3.7 requires verification of effective corrective action on a " timely basis." Timely basic in ir*erpreted to--mean w-i-thi n the framewor cr period of time f o r compte tri er of-so44eo -

t44e--ast-ten--t-hat-hs-ascepted- by t he Qua4-i-t-y--Assw-anse -Depa r teeet or Quality Servicer Departner+t. Each -- f i nd iaq--+ equi t ec a r+pwre and 2-corrective action completion date: there d2 tes--a-se : ub j ect te revisier (with the approva,L-of-the Quality-Asswance Depart-ment cr Oua1i ty Se rv ice r Depar-trent4.-and--mus t bc -esea-M Hi--be h-i-gher-auMor-i t y u!' ^ "

• 50 : e i c a d i saqFeemeet--beheen-We

. s +i-bed and the a uh-g o rg aniza t ions-- on " hat const-i-t-ubeE - 1 -me-It gnerace;un n e v ; o r, -n

. .n TAT y With regard to Section 3.4 of ANSI N45.2.12-1977 titled _9it h# # Planning: Identical or equivalent controls are provided in i is OQAM, Section 18.

A-30 Rev. 14 l 6/91

1, l

, OQAM CN 90-10 l

INSERT-l Verification of the implementation of corrective action is performed as indicated in Section 16 of this OQAM. The effectiveness of previous corrective action is determined through audit or surveillance as described-in Section 18 of this OQAM, 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 ~.

Page A-30a

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

t J .

OQAM c,a to -Id APPENDIX A

-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 subsection- 4.4.4, but they shall provide a summary of the audited areas and the results which identify the importaace of-any-adverse findings.

With- regard to Section 4.5.1 of ANSI N45.2.12 - 1977 titled .By '-

LAudited Organization: UE shall comply with the following clarifi-

'gg gg - cation- of the Section: Manag- ent of the audited crgan!zation --

F",4 activity" shall review an investigate adverse audit findingpr'as ,

J Ogf necessary,- (e.g. where th cause is not already known, f& organizacion has_ not alrea investicated and found JA6, another cause,

-etc.) to- determine and sche le appropriate cor rydive action including l action?to prevent re trence. They sh 11 clearly state-the corrective-acti'on taken or p(anned to pr ent recurrence and the results ofLthe investigation, I condu ed. In the event that corrective action is not complet d hin thirty days, the audited organizatica's- response sh include a scheduled date for completioncof planned correc (jve a tion. The audited organi- -

zation-~shall -take appropriat action t assure that corrective action is accomplished-as e eduled. Since the auditing organiza--

tion tracks acheduled orrective action mpletion dates _and  :

verit!ies . corrective ction completion, a fo. ow-up response by '

the-. audited orga, ation' stating the correctiv action taken.and 1

the date that t action was completed is not ne ssary, provided corrective- tions are completed as specified. If corrective +

actiots e not completed as specified, the_audite organization

-shall, rovide .a revised response stating the correc ive- action th W has1been taken, the corrective action yet to be empleted, g.d 't he dc.te - tha+-al-1-eeMeet-ive-ectier. ;;ill bc c=plc tc .

W=

REGULATlRY; GUIDE 1.146 INITIAL-ISSUEL DATED 8/80 Qualification of Quality Assurance Program Audit Personnel _ for -

Nuclear Power Plar.ts (Endorses ANSI N45.2.23-1978)

• DISCUSSION:

'o UE: . coraplies with the recommendations of this Regulacory Guide with the following' clarifications:

With respect to Section 1.4 of ANSI N45.2.23-1978 titled Defini- (

tions: Definitions in this-Standard.which are'not included in ANSI N45.2.10. shall be used: " Audit" which.is included in this '

Standard and ANSI N45.2.10 shall be used as clarified in this Appendix under Regulatory Guide 1.74, t'

i t

A-33 Rev. 14 6/91

_ _ m .- - . __ _ _ _ ,..._ _ _ _ _ _ . . _ _ - _ . _ . _ _ . . _ _ ,m

OQAM CN 90-10 i

INSERT Management of the audited organization or activity shall review and investigate adverse audit findings, as necessary, (e.g. where the cause is not already known, another organization has not alresdy investigated and found the cause, etc.) to determine and schedule appropriate remedial action. The audited organization shall assure documentation of remedial action taken is provided.

Adverse audit findings shall be evaluated to determine the need for action to prevent recurrence. If such action is deened 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 organizotion. 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 as scheduled. In the event the action or schedule of implementation must be changed, the audited organization shall provide a revised response 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. Tracking of evaluation progress and corrective action implementation will be performed in accordance with provisions of Section 16 of the Union Electric Operating Qutlity Assurance Manual.

With regard to Section 4.5.2 of ANSI N45.2.12-1977 titled By Auditina Oraanization: UE shall comply with the following clarification 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 of this OQAM. The audit program implemented in Section 18 of this OOAM providos assurance that responses are adequate and actions are identified, scheduled, and accomplished. Therefore, the auditing organization will not necessarily evaluate the adequacy, assure action is identified or scheduled or confirm that corrective action is accomplished as scheduled for audit findings. For external audits this section shall De complied with as written.

Page A-33a I

' ' " .. h 4,

ATTACHMENT 2

/////////////////////////////////////////////////////////////////////////////////////////////

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

s

////////,///////////////////////////////////////////'//////////////!/////////////////////////

Attachment 2 L ,

L Page 1 of 3 EXPLANATIONS OF AND JUSTIFICATIONS FOR PROPOSED CHANGE TO THE OPERATING QUALITY ASSURANCE MANUAL (OQAM)

///////////////////////////////////////////////////////////////////////////////////l/////////

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 implementatic . based on who originated the corrective action document is unnecessary.

Additionally, since many conditions adverse to quality identified by QA are not significant, impor.ing the additional verification activity may detract from the assessments of more significant areas. This revision is a lessening of our previous quality program 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 ce evaluated, accepted, and verified by QA or Quality Services Division personnel, this is done in accordance with procedures which implement the provisions of Chapter 16 of thin OQAM. This clarification and revision of Chapter 16 will require no revision to our practices for conditions adverse to quality identified relative to suppliers.

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 s

b _. . _ _ _ . _ _ _ . _ _ _ . _ _ . _ . _ _ . _ _ _ _ _ _ _ _ _ _ _ _ _ . _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

Attachment 2 Page 2 of 3 date revisions for QA originated conditions adverse to quality. The basis for this change is explained in Justification 1, for revision to Chapter 16 of this OQAM.

Since QA is no longer interpreting timeliness based on corrective action schedule accuptance, 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 be restated here. Verification of effectivenesu of previous corrective actions is through the normal audit and surveillance process and trending of corrective action documents.

Either QA or Quality Services Department personnel will continue to review and approve responses to corrective action documents sent 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 items consistent with their significance.

Significance is based on nuclear safety, radiological cafety, 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-audit by QA will indicato 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 Items identified by persennel other than QA will h..o 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 arbitrary time period, e.g. thirty days.

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

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

Attachment 2 Page 3 of 3 Qu111ty Assurance Program requirements for corrective action. While the elimination of the 30 day response time for audit findings may be considered a lessening of previous commitments, this change does not reduce 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 standard, 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 findings do need to be evaluated for adequacy and implementation verified by either QA or Quality Services Department.

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

d V