ML18005A337
| ML18005A337 | |
| Person / Time | |
|---|---|
| Site: | Harris  |
| Issue date: | 01/29/1988 |
| From: | CAROLINA POWER & LIGHT CO. |
| To: | |
| Shared Package | |
| ML18005A336 | List: |
| References | |
| CQAD-80-1, NUDOCS 8803160255 | |
| Download: ML18005A337 (51) | |
Text
~ e IA CONTROL NO ~
CAROLINA POWER 6 LIGHT COMPANY CORPORATE QUALITY ASSURANCE DEPARTMENT TITLE:
PROCEDURE FOR CORPORATE A AUDITS
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CQAD 80-1 Date 12/31/85 Rev.
10 Rev ~
No.
Revision Description Recommended By Concurred Approved By Effective Date Date
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Administrative Changes V
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~ II 8803160255 880222 PDR ADOCK D5000400 6
PDR CQAD 80-1 Page 1 of 48 Rev.
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PROCEDURE FOR CORPORATE A AUDITS 1.0 PURPOSE To provide a procedure for the prepaxation, notification, performance, reporting, and follow-up of Corporate Quality Assurance audits in accordance wi'th the Carolina Power 6 Light Company Corporate Quality Assurance Program and personneL screening program (PSP) audits conducted in accordance with Reference 3.9, and to define and assign responsibility fox the accomplishment of this procedure.
2.0 DISCUSSION 2.1 This procedure px'ovides requi.rements and guidance for the preparation, notification, performance, reporting, and follow-up of Corporate QuaLity Assuxance audits of the foLlowing activities'.
2.1.1 Nuclear Generation and Opex'ations Support Quality Assurance Program 2.1.2 Contractor and Vendor Quality Assurance Pxogram 2.1.3 Personnel Screening Program for Unescorted Access to CP6L Nuclear Plants CQAD 80-1 Page 2 of 48 Rev.
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PROCEDURE FOR CORPORATE A AUDITS
3.0 REFERENCES
3.1 CP6L Corporate Quality Assurance Program 3.2 CQAD 40-1, "Contractor and Supplier Evaluations" 3.3 CQAD 20-2, "Procedure for Training and Qualification of Quality Assurance Program Audit Personnel" 3 ~ 4 II CQAD 90-3, Requirements for Collection, Storage, and Maintenance of Quality Assurance Records" 3.S AP"6, "Protection of Safeguards Information" 3.6 CQAD 10"3, "Matrix for Determining Audit Requirements" 3.7 CQAD 20-3, "Training and Qualification of QuaLity Assurance Engineering Unit Personnel" 3.8 CQAD 20-4, "Training and Qualification of Vendor Surveillance Unit PersonneL" 3.9 "Personnel Screening Criteria for Non-Licensee Personnel" 3.10 CPhL's Drug and ALcohol Abuse Program CQAD 80-1 Page 3 of 48 Reo.
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PROCEDURE FOR CORPORATE A AUDITS 4.0 DEFINITIONS 4.1 Nonconformance - A deficiency in characteristic, documentation, or procedure which renders the quality of an item or activity unacceptable or indeterminate.
Nonconformances will be categorized as either findings or concerns>
each shall require a written response.
4.1.1 Finding - A nonconformance identified as a physical defect, test failure, or failure to compLy with the approved Quality Assurance Program requirements other than administrative requirements during
- design, engineering, procurement, construction, operation, or t
maintenance.
4.1.2 Concern " A nonconformance identified as incorrect or inadequate documentation or failure to comply with administrative requirements of the approved Quality Assurance Program.
4.2 Comment, - A questionable practice which has the potential for causing a nonconformance, or addressing a situation where additional information is required for evaluation of acceptability.
Comments shall, not require a written response.
0 CQAD 80-1 Page 4 of 48 Re'v.
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PROCEDURE FOR CORPORATE A AUDITS 4 ~ 3 Technical Specialist " An individual who, by education, experience, or training or a combination thereof, has been evaluated and selected to provide assistance in a designated area of a specific audit.
When audit responsibilities are discussed in this procedure, the technical specialist is responsible for performing the duties assigned to the auditor.
Additional terms and definitions applicable to the QA Audit Program are contained in the CP&L Corporate QA Program Manual.
5.0 RESPONSIBILITY 5.1 Authority and responsibility for the administration and execution of the quality assurance requirements are described in the CP&L Corporate QA Program.
5.2 The Manager - QA Services is responsible for implementation of the Corporate QA Audit Program in accordance with this procedure.
5.3 QA Services Unit Principals are responsible for principal assistance to the Manager - QA Services for implementation of the Corporate QA Audit Program in accordance with this procedure, as follows:
5.3.1 The Principal QA Specialist - Performance Evaluation is responsible for'.
internal audits of CP&L organizations>
preparation of the QA Services Section audit schedule, and maintenance of this procedure.
CQAD 80-1 Page 5 of 48 Rev.
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PROCEDURE FOR CORPORATE A AUDITS 5,3.2 Principal QA Specialist - Vendor Surveillance is responsible for contractor,
- supplier, and personneL screening program audits.
5.3.3 Principal QA Specialist - QA Engineering is responsible for Architectural Engineer, Nuclear Steam Supply-System supplier, and engineering contractor audits'.4 Preaward and periodic audits of contractors and suppliers shall be performed in accordance with Reference 3.2.
5.5 The assigned Lead Auditor is responsible for.') audit notification,')
audit agenda/plan preparation;
- 3) assignments to auditors;
- 4) audit checklist preparation',
- 5) orientation of auditors,
- 6) audit group travel arrangements>
- 7) conduct of preaudit and postaudit meetings,')
coordination and supervision of audit group performance',
- 9) preparation of the written audit report; and
- 10) initiating, completing, and reporting the follow-up action taken as a result of the audit.
CQAD 80-1 Page 6 of 48 Rev.
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PROCEDURE FOR CORPORATE A AUDITS
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6.0 PROCEDURE 6.1
~Sehedulin 6.1.1 A quarterly audit schedule of internal and external audits, similar I
e to Enclosure 11, shall be prepared by the Principal QA Specialist "
Performance Evaluation listing the activities to be periodicalLy audited, audit staffing, and the month in which the audit is planned.
The Principal QA Specialists - Vendor Surveillance and QA Engineering will provide their respective unit audit schedules to the Principal QA Specialist - Performance Evaluation for inclusion in the quarterly schedule.
Audit changes may be made by the Unit 0
Principals with notification qf the significant changes to the Manager - QA Services.
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6.1.2 Lead Auditor and auditor assignments will. be made by the responsible Unit Principal.
.Each Unit Principal will ensure that Lead Auditors and Auditors from his unit are appropriately trained and indoctrinated to plan, conduct, and report audits in accordance with Reference 3.3, supported by References 3.7 and 3.8, as appLicable.
Reference 3.2 of this procedure provides guidance for preaward audits.
Each Unit Principal will also ensure that technical specialists possess the 'necessary qualifications to perform an audit in the technical specialists'rea of expertise.
CQAD 80-1 r'e Page 7 of 48 Rev.
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PROCEDURE FOR CORPORATE A AUDITS 6,],3 Audit frequency is based on the status and relative nuclear safety-related importance of each activity to assure compliance with the applicable program.
Additional audits may be performed at any time at the discretion of the Manager - QA Services.
6.1.3.1 Applicable elements of the QA Program for nuclear plant operations shall be audited within the established frequency identified by the individual plant technical specifications.
6.1.3.2 The need for periodic supplier audits to maintain qualification shall be evaluated and determined by the Principal Vendor Surveillance Specialist/Principal QA Engineer (as appLicable) in accordance with Reference 3.2.
6.1.3.3 PSP audits shall be scheduled based on recommendations from the Nuclear Staff Support. Section with the audit requirements based on References 3.9 and 3.10 compliance, as applicable.
6.2 Audit Pre aration 6.2.1 The Lead Auditor:
6.2.1.1 Prepares an audit agenda/plan (see Enclosure
- 2) identifying the audit
- schedule, scope, requirements, activity to be audited, applicable documents, and auditors'repares an audit notification letter which CQAD 80-1 Page 8 of 48 Rev.
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PROCEDURE FOR CORPORATE A AUDITS transmits the audit agenda/plan and identifies the audit schedule.
These documents should be prepared approximately one month prior to an audit and submitted to the cognizant Unit Principal for review and to the Manager " QA Services for approval signature.
Distribution of these documents shall be made in accordance with Enclosure 1, except for PSP audits which are distributed to the Nuclear Staff Support Section and appropriate nuclear project management.
For external audits, the audit agenda/plan shall provide notification to the responsible individual in the company being audited.
These organizations should receive the audit agenda/plan approximately thirty (30) days prior to the scheduled audit date and are responsible for providing notification to the activity being audited.
6.2.1.2 Prepares a checklist of characteristics for the activity being audited.
Standard checklist(s),
such as Form 1483, Manufacturer Evaluation; Form 1483-1, Laboratory Services Evaluation'or Form 1483-2, Vendor Evaluation for ASME BSPV Code,Section III, NCA-3800; may be used.
See Enclosure 3 for example.
If a special checklist is necessary, a form, such as Enclosure 4, will be used.
Previous audit nonconformances that are open or require verification shall be included on the current audit checklist.
The auditor shall report in the comments section of the checklist the results of his evaluation, ini.luding a specific statement of the current status of each item; e.g.,
open, closed, unsatisfactory, etc.
CQAD 80"1 Page 9 of 48 Rev.
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PROCEDURE FOR CORPORATE '
AUDITS Sources'f information used for preparing the checklist should include, but not be limited to, the following documents as applicable:
FSAR> Technical Specifications, QA plan of the activity being audited (when available), prior audits, NRC compliance and regulatory correspondence, and Program.
Any other sources of CP&L Corporate Quality Assurance information pertinent to quality or nuclear safety may be employed at the discretion of the Lead Auditor.
Reference 3.9 is the basic document for prepa'ration of PSP audit checklists.
The Incomplete Checklist Items Log will be reviewed by the
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responsible Lead Auditor for subsequent audits to ensure that follow-up items are included in the checklist for subsequent audits.
6.2.1.3'erforms orientation and briefs the auditors on the audit and makes the following available to the auditors:
agenda/plan, applicable checklists and procedures, standards, instructions, and other pertinent data.
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'1 6.2.1.4 Assures that auditors understand organizational responsibilities and/or contractual interfaces of the activity being audited.
0 CQAD 80-1 Page 10 of 48 Rev.
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PROCEDURE FOR CORPORATE A AUDITS 6.3 Performin the Audit 6.3.1 A preaudit meeting will be conducted by the Lead Auditor with management of the audited activity to.
review the audit scope, present the audit plan, introduce auditors, meet counterparts, discuss audit sequence, establish channels of communication, and discuss plans for the postaudit meeting.
Where PSP audits are conducted in the General Offices of CPSL, a preaudit telephone conference is conducted in lieu of a meeting.
6.3.2 The audit is performed by the auditors.
The checklist shall detail the information obtained during the audit, such as items checked and conditions identified.
Open items from previous audits which are determined to have been satisfactorily completed shall be indicated in the checklist.
When a nonconformance is identified during the audit which has also been identified and documented by the audited organization's quality assurance personnel or by the NRC, the following action(s) shall be taken:
- 1) if the nonconformance identified by the audited organization's QA personnel/NRC, as applicable, has been resolved with documented corrective action to the point of closure, the auditor shall record the conditions found on the audit checklist together with annotation that the nonconformance was identified and closed by the audited organization/NRC as applicable;
- 2) if the audited organization has not taken the necessary corrective action to resolve. the CQAD 80-1 Page 11 of 48 Rev.
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PROCEDURE FOR CORPORATE A AUDITS nonconformance the auditor shall record the status of the nonconformance in the audit report along with a current assessment of conditions and parameters pertinent to the deficiency.
6.3.2.1 Incomplete checklist items will be identified on the audit checklist along with the reason the items were not checked.
Checklist questions not answered will be entered in a Log and evaluated by the I
Lead Auditor to determine if follow"up during a subsequent audit is neces8eay.
The results of this evaluation will be recorded in the Loge 6.3.2.2 If checklist questions are not being answered because the activity is not in progress during the audit, the auditor shall review documented records which reflect accomplishment of the activities which may have been performed during an earlier time period.
The auditor shall answer the checklist questions from the results of this document review.
6.3.3 Com liance Verification 6.3.3.1 The checklist shall be used as a guide and shall not, restrict the audit investigation.
Additional questions, not specifically included in the checklist, which are necessary to complete the investigation wilL be drafted,
- answered, and included in the checkList.
CQAD 80-1 Page 12 of 48 Rev.
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PROCEDURE FOR CORPORATE A AUDITS
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6.3.3.2 Objective evidence shall be examined for compliance with the audited
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actxvxty s QA program requirements, and documented on the audit checklist.
6.3.3.3 Selected elements of the audited activity's QA or PSP program shall be audited to the depth necessary to determine if the audited program is being effectively implemented.
6.3.3.4 For audit nonconformances, the objective evidence reviewed shall be identified to aid in further required investigation.
6.3.3.5 Mhen a nonconformance is identified during the audit, the audited management shall be notified.
6.3.3.6 When a nonconformance, which requires immediate corrective action, is identified during the audit, a verbal report will be immediately made to the manager of the audited activity or his designee.
6.3.3.7 During each audit of an operating nuclear plant, a general walkthrough inspection will be conducted by the auditors to determine the status of housekeeping.
CQAD 80-1 Page 13 of 48 Rev.
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PROCEDURE FOR CORPORATE A AUDITS
.0 6,3,4 Postaudit Meetin A postaudit meeting between the auditors and management of the audited activity will be conducted by the Lead Auditor to present and clarify audit results.
At this time, the management of the audited activity may indicate any corrective action they plan to initiate for identified nonconformances and a tentative date for implementation and/or resolution of identified nonconformances.
Audited management shall be requested to acknowledge understanding of each f ~
nonconformance, whether or not they agree with the nonconformance.
When PSP audits are conducted in the General Offices of CPGL, a
postaudit telephone conference is conducted in lieu of a meeting.
- 0 To ensure that timely notifications of unsatisfactory audit results are provided, the following reports shall be made:
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The Lead Auditor will inform the cognizant Unit Principal or his alternate by telephone.
If this can not be done from the audit
- location, the report will be made at the start of the next working day.
b.
The Unit Principal will immediately notify the Manager - QA Services or his alternate.
In the case of unsatisfactory vendor
- audits, he will also notify the following when he and the Section Manager co.icur with the Lead Auditor's evaluation:
CQAD 80-1 Page 14 of 48 Rev.
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'0 PROCEDURE FOR CORPORATE A AUDITS (a)
Unit Principal, Vendor Suxveillance Unit (b)
- Manager, Procurement Support (c)
Project Specialist, Security in the Nuclear Staff Support Section for unsatisfactory Pexsonnel Scxeening Program audits'.
The Manager - QA Services or his alternate will notify the Manager - Corporate Quality Assurance Department at the first opportunity.
6.4
~Re ortin The preparation of the audit repoxt is the responsibility of the Lead Auditor, to be accomplished in accordance with the following requirements.
The basic format of Enclosure 5 shall be used in preparing the report.
6.4.1 The heading of the report shall be completed with the name of the audited activity, audit number, audit report issue date, name(s) of the auditor(s) (indicating the Lead Aud'itor) including technical specialists, and the names and positions of the personnel contacted who provided pertinent information during conduct of the audit.
An asterisk (*) will be placed by the names of persons who attended the preaudit meeting.
A double asterisk (~) will be placed by the names of persons who attended the postaudit meeting.
A triple asterisk 0
1 CQAD 80-1 Page 15 of 48 Rev.
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PROCEDURE FOR CORPORATE A AUDITS
(~) will be placed by the names of persons who attended both the preaudit and postaudit meetings.
6.4.2 The "Scope" section details the guidelines used to conduct the audit and identifies the areas audited.
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6.4.3 The "Summary" section highlights the results of the audit and details the main conclusions such as nonconformances (if appropriate),
status of the program, verification of corrective action from prior audits, and a conclusion regarding the overall effectiveness of the program.
The number of nonconformances identified will be included, and any nonconformances closed during the audit shall be identified.
A general statement on housekeeping shaLL" be incLuded in the summary for audits of operating plants.
The audited management shall be requested to formally respond to the audit report nonconformances within thirty (30) days of the audit report issue date.
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6.4.4 Comments shall be itemized and listed in a paragraph following the listing of nonconformances or provided to the audited management by memorandum from the Manager - QA Services Comments do not require a
written response.
6.4.5 The results of verification of actions to resolve nonconformances E
from previous rsdits not previously verified shall be reported and the status of the nonconformances identified.
CQAD 80-1 Page 16 of 48 Rev.
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PROCEDURE FOR CORPORATE A AUDITS 6.4.6 Nonconformances, including recommendations as appropriate, shall
.be itemized and listed on the Audit Nonconformance Report (Enclosure 6).
Each form (Enclosure
- 6) shall describe the nonconformance and the corresponding acknowledgement and response (if any) provided by the audited organization.
The Audit Nonconformance Report shall include the criteria which establishes the requirements.
When the response of the audited activity includes the corrective action and/or action to prevent recurrence for the nonconformance, the response shall also include the scheduled date of implementation.
The acknowledgement and response may also contain any explanation of the nonconformances by the audited management and/or the auditors.
6.4.7 Audit resuLts, incLuding responses, which relate to any nuclear plant or industrial security system and which have been determined to be CP&L Company Safeguards information shall be detailed in an attachment to the audit report (Reference 3.5).
Distribution of this attachment will be'to those having a "need"to-know" as determined by the Manager " QA Services.
6.4.8 The audit report will be signed by the Lead Auditor, reviewed by the cognizant Unit Principal and approved by the Manager " QA Services'he audit report shall be submitted to the Manager " QA Services in sufficient time to obtain approval by the Manager - Corporate Quality CQAD 80-1 Page 17 of 48 Rev.
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PROCEDURE FOR CORPORATE A AUDITS Assurance to enable the report to be issued within thirty (30) calendar days after the audit.
6.4.9 Following approval of the audit report by the Manager " Corporate QA, the Manager - QA Services shall ensure distribution to management of the audited activity and to other CP&L management with responsibilities for the audited activity (identified in ).
An audit report cover letter shall be prepared and issued to the designated management of all non-CP6L organizations audited.
This letter shall be signed by the Manager - QA Services and dated indicating the audit report issue date.
The letter shall, as a
minimum, contain the following.'.
Date of issue.
b.
Concise summary statement of number of nonconformances identified.
c.
The status of the audited organizations program as effective and satisfactory or unsatisfactory.
d.
Summary of the requirements of response:
- details, schedules, etc., if required.
e.
Identification by name and title of the CPSL management individual to whom responses are to be addressed.
CQAD 80-1 Page 18 of 48 Rev.
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PROCEDURE FOR CORPORATE A AUDITS f.
Instructions to include the Manager - QA Services in the distribution of all related correspondence sent to CP&L.
Distribution of the report cover letter shall include the Manager-Corporate QA and the individual detailed in item (e) above.
6.4.10 A memorandum shall be prepared, concurrent with the audit report, for submittal to the Senior Executive Vice President " Power Supply and Engineering
& Construction by the Manager - Corporate Quality Assurance which summarizes the.audit report (and includes the audit report as an encLosure).
(For preaward audits, the memorandum shall be submitted to the Manager " Corporate Quality Assurance by the Manager " QA Services.)
This memorandum shall provide a method for the Senior Executive Vice President (Manager - Corporate Quality Assurance for preaward audits) to indicate his comments and document his review of the audit report.
This memorandum, with appropriate
- comments, shall be returned to the Manager - Corporate Quality Assurance (Manager - QA Services for preaward audits) and will be retained in the Corporate Quality Assurance Department files.
6.4.11 Preaward audit reports reviewed by the Manager - Corporate Quality Assurance shall be retained in the Corporate Quality Assurance Department files.
Reports of internal audits, periodic externaL
- audits, and PSP audits reviewed by the Senior Executive Vice President - Poser Supply and Engineering
& Construction shall also CQAD 80-1 be retained in the Corporate Quality Assurance Department files'age 19 of 48 R'ev.
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PROCEDURE FOR CORPORATE A AUDITS 6.5 Follow-u Action 6.5.1 As requested by the audit report and the cover letter, the audited activity management identified in Enclosure 1 shall review the nonconformances identified in the audit repott; determine and schedule appropriate corrective and preventive actions; and respond to the applicable purchasing manager with a copy to the Manager - QA Services for external audits, or to the Manager - QA Services for internal audits, in writing, within thirty (30) days of the issue date of the report, giving results of the review and investigation.
A satisfactory response shall clearly state the cause, effect (internal audits), corrective action and preventive action taken.
In the event that actions cannot be completed within thirty (30) days, the response shall include a scheduled date for completion.
A follow-up response shall be submitted stating the actions taken and the date(s) of completion.
The Lead Auditor of the most recent audit shall be responsible for action follow-up of all open nonconformances for that organisation including completion of all pertinent documentation.
If the audited activity management fails to respond within the thirty"day time period or by the scheduled date for completion of actions, the Lead Auditor shall contact the responsible management designee to obtain information as to when the proper response will be submitted.
The Lead Auditor shall document this action and the response commitment received from the responsible CQAD 80 1
Page 20 of 48 R'ev.
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PROCEDURE FOR CORPORATE A AUDITS manager.
This may be in the form of a handwritten record of the conversation and shall be filed in the audit report file.
6.5.2 The response document describing what action has been taken by the audited management shall be routed to the appropriate Lead Auditor for review.
The Lead Auditor shall evaluate the adequacy of the action taken to close out the nonconformance(s) and prepare a reply letter for external audits (or a memorandum for internal audits) for review by the cognizant Unit Principal and approval by the Manager-QA Services.
This letter or memorandum shall summarize and report the status of all nonconformances including the schedule of an additional response, if required.
The Manager - QA Services shall ensure that the results of the evaluation are forwarded to the audited activity management and to the Manager - Corporate Quality Assurance.
A change to the initial resolution must be approved by
'the Manager - QA Services.
If a second change becomes necessary, it must be approved by the Manager - Corporate Quality Assurance.
6.5.3 For internal audits, if the Manager - QA Services and the audited organization cannot agree on corrective action, the matter shall be resolved by referral to the appropriate management level of both organizations.
Referral level is defined in Section 6.7 of this procedure.
CQAD 80-1 Page 21 of 48 Rev.
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PROCEDURE FOR CORPORATE A AUDITS 6,5,4 The following measures have been established to assure timely correction of internal audit nonconformances:
the initial resolution of a nonconformance submitted to QA Services shall be approved by the Plant General Manager or Section Manager of the audited activity.
A change to the initial resolution will not be accepted by QA Services unless approved by the Department Manager of the audited activity.
If a second change becomes necessary, it will not be accepted unless approved by the Group Executive of the audited activity.
Changes in the corrective action schedule require approval by the Plant General Manager or section manager of the audited activity.
6.5.5 For internal audits, the Lead Auditor shall escalate the nonconformances as defined in Section 6.7 of this procedure if a response is not received within the required time Limit or if an acceptable resolution is not obtained.
The Manager - Quality Assurance Services may grant one extension, not to exceed thirty days, in response to a written request for an extension of the response schedule if received within the original scheduled period.
Additional extensions shall require the concurrence of the Manager-Corporate Quality Assurance.
All extensions shall be documented and placed in the audit file.
6.5.6 For internal and external audits, the current audit activity will include the evaluation and report of the status of all nonconformances identified during prior audits which have not been CQAD 80-1 Page 22 of 48 Rev.
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PROCEDURE FOR CORPORATE A AUDlTS previously closed by verification of corrective action.
The status of each nonconformance remaining open will be identified and reported by audit number, and finding and concern number.
Corzective action reported foz each nonconformance will be verified and the nonconformance will be closed if adequately implemented.
The status of nonconformances to which the audited orgahisation has not issued a
response will be-evaluated
.and should be closed if:
(1) the Lead Auditor considers the implemented corrective action to be satisfactory; and (2) a written report of the action, taken is received prior to issue of the current audit zeport.
6.6 Escalation Process 6.6 1
A Corrective Action Request (CAR) form (Enclosure
- 8) shall be prepazed by the Lead Auditor and issued by the Principal QA Specxalxst - Performance Evaluation to escalate an internal audit report nonconformance if one or more of the following occurs:
a.
The required response is not received within five (5) working days after the specified due date.
The CAR shall be initiated by the fifth (5th) working day after the specified due date.
b.
The initial z'esponse received is not satisfactory and a
satisfactozy resolution cannot be reached, as determined by the Lead Auditor.
The CAR shall be initiated within five (5) working CQAD 80-1 Page 23 of 48 Rev.
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PROCEDURE FOR CORPORATE A AUDITS days of the date that a satisfactory resolution can not be reached.
c.
Corrective action is not satisfactorily completed by the specified completion date.
The CAR shall be initiated within five (5) working days of the date the coirective action was due.
6.6.1.1 Consecutive numbers will be assigned to CARs with a listin 1$
Lng maintained in a log book by the Principal QA Specialist " Performance Evaluation.
6.6.2 The Lead Auditor shall identify the item being escalated and the reason for escalation on the CAR.
A copy of the item being escalated shall be attached to the CAR.
The CAR shall be forwarded by the Principal QA Specialist - Performance Evaluation to the applicable Plant General Hanager or Section Hanager and the Manager - QA Services.
6.6.2.1 The Lead Auditor will continue attempts to obtain satisfactory resolution after the CAR is issued.
However, if resolution is not obtained within ten (10) days a conference will be held as described in 6.6.3.
If resolution is obtained within ten (10) working days
- ays, the CAR will be marked as closed, and signed by the Lead Auditor and filed in accordance with 6.6.6.
CQAD 80-1 Page 24 of 48 Rev.
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PROCEDURE FOR CORPORATE A AUDITS 6.6,3 Conference.
Applicable Plant General Manager or Section Manager Manager - QA Services This conference shall be held within ten (10) working days from the date of issuance of the CAR. If satisfactory resolution is reached as a result of this conference, the resolutionlcorrective action assigned shall be noted on the CAR which shall.
become a part of the basic document which was attached for escalation.
If the item remains unresolved after the conference (or the conference is not held within ten (10) working days) between the applicable Plant General Manager or Section Manager and the Manager - QA Services, the reason shall be noted on the CAR and it shall be forwarded to the applicable Department Manager and the Manager - Corporate Quality Assurance for a conference.
6.6.4 Conference
Applicable Department Manager Manager - Corporate Quality Assurance This conference shall be held within ten (10) working days from the date of receipt of the CAR as noted above.
If a satisfactory resolution is reached as a result of the conference, the resolution/
corrective action assigned shall be noted on the CAR, which shall become a part of the basic document which was attached for escalation.
When an item cannot be resolved (or the conference is not held within ten (10) working days) between the applicable CQAD 80"1 Page 25 of 48 Rev.
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PROCEDURE FOR CORPORATE A AUDITS 0
Department Manager and the Manager - Corporate Quality Assurance, the reasons shall be noted on the CAR and it shall be forwarded to the applicable Group Executive and the Manager " Corporate QA for a conference.
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6.6.5 Conference
Applicable Group Executive Manager " Corporate Quality Assurance This conference shall be held within ten (10) working days from the date of receipt of the CAR as noted above.
If a satisfactory resolution is reached as a result of the conference, the resolution/
corrective action assigned shall be noted on the CAR, which shall become a part of the basic document which was attached for escalation.
When an item cannot be resolved (or the conference is
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not held within ten (10) working days) between the applicable Group Executive and Manager - Corporate Quality Assurance, the reasons shall be noted on the CAR and it shall be forwarded within five (5) working days to the Senior Executive Vice President - Power Supply and Engineering 6 Construction for a final decision.
The final corrective action shall be noted on the CAR.
The CAR shall be returned to the Manager - Corporate Quality Assurance for distribution to affected parties and to the Manager " QA Services for verification of implementation.
4 6.6.6 Copies of the CAR shall be distributed as follows (as marked by "X")
for each respective escalation conference.
Following final disposition, the CAR will be filed in the applicable audit file.
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'I CQAD 80-1 Page 26 of 48 4
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PROCEDURE FOR CORPORATE A-AUDITS CAR Escalation Conference Levels Distribution To Reci ients 1
1.
Plant General Manager/
Section Manager Section/Plant General Manager and Manager-A Services Manager-CQAD and Appl.icabl.e Manager " CQAD Department and Appl.icable
~Mana ar Grau Exacuciva 2.
Lead Auditor 3 ~
Principal QA Specialist PEU Prepares Submits X
X'.
Manager - QA Services 5 ~
Applicable Department Original 6.
Manager - Corporate Quality Assurance Original.
T.
Applicable Group Executive 8.
Senior Executive Vice President Original Copies of the CAR shall be distributed to the responsible individuals prior to a conference.
For each conference held, if a resolution is reached, the original.
copy of the CAR shall be returned to the Manager -
QA Services for the audit file.
If a
resolution is not
- reached, distribution is made for the next conference as shown by an X.
Encl.osure 9 is a flow chart showing the normal flow for the documents which identify and report nonconforming conditions and the interface with the escalation flow path when it becomes necessary.
CQAD 80-1 Page 27 of 48 Rev.
14
PROCEDURE FOR CORPORATE A AUDITS 6.7 Audit Status Record The QA Audit. Status Record (Enclosure
- 7) for each audit shall be prepared and maintained by the Lead Auditor.
A separate QA Audit Status Record may be prepared for each nonconformance when necessary.
As the status of nonconformances-changes, the Lead Auditor shall update the QA Audit Status Record to indicate the current status.
Mhen all required action has been reported complete, the Lead Auditor shall sign and date the QA Audit Status Record(s) to indicate the audit is closed.
QA Audit Status Records for closed audits shall be filed in the audit file.
Implementation of corrective/preventive actions will be verified during the next regularly scheduled audit of the activity, if applicable.
The status of all nonconformances will be listed on the Audit Status Record of the current audit.
6.7.1 Meekl Audit Activit Re ort A weekly activity report is prepared under the direction of the Manager QA Services using the format of Enclosure 10.
6.8 A monthly report indicating audits conducted, reports issued during the month, and status of nonconformances shall be prepared by the CQAD 80"1 Page 28 of 48 Rev.
14
PROCEDURE FOR CORPORATE A AUDITS Principal QA Specialist - Performance Evaluation for submittal by the Manager " QA Services to the Senior Executive Vice President - Power Supply and Engineering 6 Construction.
6.9 Records of the Audit 6.9.1 A separate file will be maintained by the QA Engineering Unit for each audit and shall contain correspondence,
- reports, and documents associated with that audit such as audit agenda, written responses and replies, and record of completion of corrective action(s).
These QA audit records are maintained in accordance with Reference 3.4.
6.9.2 When the audit checklist questions have been answered and proof-read by the audit group members, the Lead Auditor shall sign and date the checklist certifying it as a completed record.
Completed audit checklists will be filed in CQAD files.
6.9.3 Handwritten and typed draft Safeguards comments/reports shall be controlled and when no longer required for preparation of the final report, destroyed in accordance with appropriate CP&L administrative procedures for destruction of Safeguards material (Reference 3.5).
6.9.4 Handwritten field notes taken by auditors may be destroyed when no longer required for preparation of the final audit report.
CQAD 80-1 Page 29 of 48 Kev.
14 I
/
~
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'I v
PROCEDURE FOR CORPORATE A AUDITS 7.0 ENCLOSURES 7.1 7.2 7.3 Enclosure 1 - Audit Documentation Distribution List Enclosure 2 - Audit Agenda/Plan Enclosure 3 - Manufacturer Evaluation QA (Form) 7,4 7.5 Enclosure Enclosure 4 - Audit Checklist (Form) 5 - Audit Report 7.6 7.7 7 ~ 8 7.9 7.10 7.11." Audit Nonconformance Report (Form)
Enclosure 7 - QA Audit Status Record and Continuation Page (Form)
Enclosure 8 - Corrective Action Request (Form)
Enclosure 9 " Escalation Flow Chart Enclosure 10 - Weekly Audit Activity Report Enclosure 11 - Master Audit Schedule/Plan CQAD 80-1 Page 30 of 48 Rev.
14
~ ~
rstg Enclosure I Page l of 3 4a CO OI 8~
4 4 CI M ~
a o CL 8 Cl R Cl AM a
Cl 4 v44 cn oe CO
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AUDIT PRE EHCT TITLE Cha i'rasa/Pres ident /CEO var va'r 1
r.
1 ri var 1 r.
1 r.
DISTRISUTION 1 r.
1 r 1 r.
var 1 r.
1 r
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Sr. Esecutive Vice President
- PS aad Engineering g
Construction ooo 2A 2A 2A so+
2A of+
2A 2A 2h 2A 2A 2A 2A 2h 2A 2A l
'I ~
r i
~
lt P
p
~
C Senior Vice President-Nuclear Ceneration Manager - Nuclear Staff oc Support Section Vice Presid~nt - Robinsoa Nuclear Project Ceneral Hanager - H. $.
Robinson Plant kobinson Construction Hansger Vice President - Harris Nuclear Project Hsasger Construction, Harris Plant bcDc 2
1c2$
Ih,b*
1,2D 2D 2D 2$
2D 2D 2b 2D 2$
2$
2$
2$
2DcK 1 ~2$
1,2$
e lhc2$
2$
2$
Hansger - Hodification Project 1,2Do h,
=c ~
1
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Ceneral Hansger - Harris Plant Hsasger - Harris Plant Adainistration lh, 2Do 1,2 D
2D 2D 2D 1,2D 2L 2D D
'C'-.l Cd 1
Enclosure 1
age 0
0 So W 0 g 8'a:
i aQ u w IS o M
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Nuclear troject Csnaral Nonager - bruasukck Plant Nsnsger gNP Engines'ring
$ Coastruction 1,2C
- lsA, 2Ca C
1,2 2C 2C 1C 1C, 2C 1,2C 1C 1C 2C 2C 2C 2C 2C 1,2C Is2C IA 2Ce 2C 2C 2C 1,2A 2C 4I
~ I 0
~r. Vice tresident-Operations Support Vice tresident - Nuclear Engineering Manager " Nuclear tlaata Engineering Nsaager - Engineering gppport Nuclear tlaata ls Il Naaagar Nuclear'ngineering Projects Noaoger - Licensing 4 Nuclear fuel Nanager - Nuclear Fuel Vice tresident - Operations Training g Technical Sea'vs.
Nansger - Health Physics lH,N I
1,2 2I 2
1 ~ 2 1,2 2I 1,2 lA,2 IAs 2e ls 2
1,2 2I 1ll I
11
<<4 1,2 1,2 lA,2 Is2 ls2 1,2 Naaager - Nuclear Training 28 lA,2 Noasger - Nuclear Safety g Envjronaental Services 2sCo lA,2 2
lA,2 Ce 2
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'F n
Enclosure I
~age oD3 04 I
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Hsnsger - Emergency Preparedness I
00 Hansyer Corporate Qualety Assurance
'I 1 ~ 2tttt 1 ~ 2 1,2
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1,2 1,2 1,2 0++
1,2 1,2 142 le2 1,2 1,2 le2 142 lhe2 le2 le2 le2 O
I04 Hsnager - Operations QA/QC Directoi - QA/QC Brunsuick Plant Director QA/QC Robinson Plant 142 B,CJD Cl,2 Bl,23'C D,
2BIC 2C 2B 2C 2C 2C 2
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++
2b
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lbe2t 142C 142b 2C 2b 1,2C le2b 2C 2
le Director - QA/QC Harris Plant Hsnsger - Qh Services Hsnayer -. Hsterisla Quality Projpct Hansger (AE or NSSS)
Project or QA Hansger (Vendor) 1 ~ 2D 1,2D lh,2 t3 2D lh,2 lA,2 t3 2D
++
2D0+
1,2D lhe2 2D 1
2D 1,2*
2D 2D lA,2
LEGEND FOR ENCLOSURE 1
(1)
Receives "Audit Notification" and "Audit Agenda/Plan" (2)
Receives "Audit Report" (3)
AE Pr'oject Manager Receives Copy of NSSS Audits (A)
Individual to whom the document is addressed (B)
Items pertaining to "RNP" (C)
Items pertaining to "BNP" (D)
Items pertaining to "HNP Engineering" and "HNP Construction" (E)
Items pertaining to Purchasing" (F)
Items pertaining to "Procurement" (G)
Items pertaining to "Environmental Monitoring" (H)
Items pertaining to "Training" (I)
Items pertaining to Nuclear Fuel, Items and Services (J)
Items pertaining to AE or NSSS purchases as applicable (K)
Items pertaining to "HNP Start-up and Operations" (L)
Items pertaining to "Contracts" (M)
Items pertaining to "Emergency Preparedness" Organisations responsible for notifying and coordinating the audited activity', and responsible for audit report follow-up.
(~)
Audit frequency"-triennially supplemented with documented annual evaluation per Reg.
Guide 1.144.
Receives documents when plant security is audited.
(~)
Receives documents when site emergency plan is audited.
(++)
Site audit only.
(+++)
Preaward audits addressed to Manager - Corporate Quality Assurance; periodic audits addressed to Senior Executive Vice President - Power Supply and Engineering
& Construction.
CQAD 80-1 Page 34 of 48 Rev.
14
ENCLOSURE 2 AUDIT AGENDA/PLAN Activity.'udit Schedule Date(s):
Auditor(s):
- Lead Auditor Requirements:
(P.O./Contract)
(Corporate QA Program)
(License), etc.
Applicable Documents.'CQAP)
(Applicable Procedures)
(QA Plan), etc.
Agenda:
1.0 Preaudit Meeting 2.0 Scope of Audit - Functional Activities 3.0 Postaudit Meeting Audit'eport No.:
CQAD Procedure No.:
NOTE:
(Not to be included on agenda)
A checklist will be prepared in accordance with the appl.icable audit procedure and used as a guide for auditing the various functional activities.
CQAD 80-1 Page 35 of 48
- j Form Ho.
1483 Revi H 6/15/79 CASE Approved 801-CE-025-Rev.
906.
Carolina Power 4 l.lght Company MANUFACTURER EVALUATION QUALITY ASSURANCE ENCLOS~
3 Date Vendor Address Phone 1
-l
~ j Contact Title Item(s)
Spec.
Ho.
Audit by P.O. No.
of Coda/Safety Class FACILITY INFORMATION Principal Products or Servicest Work Distribution:
Z Coomercial Nuclear Z
Navy Nuclear Z
Coamercial Z
Other Code Stamps and Authorizations.'otal Number of Empl.oyees Number of Shifts d
Total Number of Quality Assurance Personnel (Inspectors included)
Revision of Quality Assurance Program Manual Evaluated Other Manufacturing Facilities on Location Coaments Dated page 36 of 48 Rev.
14
QUALITY ASSURANCE AUDIT CHECKLIST 00 C)
I RE PORT NO:
QAA//
ACTIVITY DATE AUDIT PROCEDURE
~
AUDIT SUBJECT LEAD AUDITOR AUDITOR~
AUDIT ITEMS
$+T UNsAT N//'A COMMENTS 0
~
ttl off Pa e
of
SAT ma'am N/~
AUDIT NO. QAA/
PAGE Of Comment
ENCLOSURE 5 AUDIT REPORT Activity Audited:
Audit Report No.:
Date(s) Audited:
Auditor(s)t Personnel Contacted:
Audit Report Issue Date:
Scope:
Summary:
I.
Nonconformances A.
Findings B.
Concerns II.
Comments III. Status"Of Nonconformances From Previous Reports Submitted by:
Lead Auditor Recommended by:
Principal QA VS Speciaiist Engineer Approved by'.
Manager - QA Services CQAD &Q-1 Page 39 of 48
~
4
~
~
,.h.
EHCLOSURE 6 Page 1 of 1
AUDIT HOHCOHFOBKlHCE REPORT REPORT NO.
AA/
DATE OF AUDIT AUDITOR HOHCOHFORHAHCE DISCUSSED WITH UNDERSTOOD h ACRHOWLEDCED SY NONCONFORMANCE NO Title Title Date NOHCOHFOBKLHCE:
I 1 ~ )
CORRECTIVE ACT10H REPLY:
(Include Cause and Preventive Action)
CLEAD 80-1 Page 40 of 48 Rev.
14 0
e
'I.
a.i@i ~
se.'
4
CORPORATE QA THRHT QA AUDIT STATUS RECORD
)HCMSURE 7 etlof'
~
1 I-FACILITY 2 QAAI HUHBER REPORT ISSUED DT 3
CLEAD NO.
4 POST AUDIT HTG ~,DT ~
5 6
LA INITIAL/NAHE:
7 AUDITOR'S INITIALS:
8 FACILITY NAHE:
9 MISCELLANEOUS INFO:
10 11 AUDIT TYPE:
INT EXT (circle one)
Findings.
Concerns:
INITIALRESPONSE DUE'2 I
~
~
PAST AUDIT F
STAT QAAg C
(If Applicable) 14 15 CRITERIA 16 17 18 CLEAD STAT NQ.
DUE DATE 19 RESP DATE STAT 20 17 CLEAD NO.
18 DUE DATE 19 RESP DATE 20 STAT 17 CQAD HO.
18 CLOSE PATE 21 E
X T
22 PRTR 23 I'
V AUDIT STATUS LEGEND ICR - Item Closed by Acceptable Response; No Further Verification Required ICRV Item Closed by Acceptable Response>
Verification Required ICA - Item Verified Cl.osed by Audit ICFR Item Closed) Failed to Respond h
FRR Response Hot hcceptable, Further Response Required OPC Open Pending Completion of Corrective Action~ Response Required RBE Response Being Evaluated (For Computer Input/Output On OPV Open Pending Verification RFRR Reopened; Further Response Required
+HOTEI ENTER DATE YYHHDD 24 AUDIT ClQSE6 a
u ator CLEAD 80-1 Page 41 of 48 Rev.
1
CORPORATE QA DEPARTMENT QA AUDIT STATUS RECORD CONTIHUATIOH MEET t
gHCIDSURE 7
}eet 2 of'.:
Number:
AA/
Lead Auditor:
PAST AUDIT F
STAT /AALU C
(lf Applicable) 14 15 CRITERIA STAT CLEAD NO.
18 DUE DATE
~ 19 RESP DATE 20 STAT 17 CLEAD NO+
18 DUE DATE 19 RESP DATE 20 17 18 CLEAD STAT NO.
CLOSE DATE 21 E
X T
22 PRTR AUDIT STATUS LEGEND ICR Item'Closed by Acceptable Response; Ho Further Verification Required ICRV Item Closed by Acceptable
- Response, Verification Required ICA Item Verified Closed by Audit ICFR Item Closed; Failed to Respond FRR Response Hot Acceptable, Further Response Required OPC Open Pending Completion of Corrective Action~ Response Required RBE Response Being Evaluated (For Computer Input/Output On OPV Open Pending Verification RERR Reopened; Further Response Required
- NOTE:
ENTER DATE YYHHDD 24 AllDIT CLOSED Lead Auditor CLEAD 80-1 Par e 49 nf hA Once
LEGEND FOR ENCLOSURE 7
1.
Facility name 2.
QAA number 3.
Date (YYMMDD) audit report is issued 4.
CQAD f assigned to audit report 5.
Date (YYMMDD) of postaudit meeting 6.
3 char.
lead auditor initials and 17 char. last name comma first and middle initial 7.
3 char. initials for all auditors participating (NOTE:
TS-is technical specialist) 8.
20 char. facility name or person responsible to respond 9.
Free format enter information that may be applicable to audit> i.e.,
phone 0, incomplete checklist items, etc.
10'udit type is internal or external ll.
Total number of findings/concerns 12.
Enter 35 days after report is issued (YYMMDD) 13.
Enter date of first response (YYMMDD) 14.
Enter QAA 0 of nonconformances that have been closed by audit (ZCA) or reopened due to inadequate corrective actions 15.
Finding/concern number 16.
For internal. audits, enter an eight-digit code based on CQAD Procedure 70-4.
For external audits, enter N/A.
17.
Status of nonconformance.
See Audit Status Legend.
18.
Enter CQAD number that establishes the status of nonconformance 19.
Due date is 35 days of the issue date for applicable CQAD letter number 20.
Enter date of response 21.
Enter date nonconformance is closed 22.
Enter a ( ) check mark for each extension that is granted 23.
Enter initials of person responsible to respond for internal audits or person responsible to expedite response for external audits 24.
Lead auditor vill sign and date when all nonconformances have been closed.
CQAD 80-1 Page 43 of 48 Rev.
14
CORRECTIVE ACTION REQUEST No.
(To Be Escalated)
CAROLINA POWER 6 LIGHT COMPANY ENCLOSURE 8
Sheet 1 of 2 Issued To:
THE FOLLOWING NONCONFORMING ITEMS HAVE NOT BEEN RESOLVED, FOR THE REASONS NOTE AND ARE BEING ESCALATED TO HIGHER MANAGEMENT FOR DIRECTION, NONCONFORMING ITEM AUDIT AND ITEM NUMBER COPY ATTACHED:
REASON(S)
FOR ESCALATION ISSUED BY PRINCIPAL QA SPECIALIST - PEU CONFERENCE RESULTS DATE 1.
Corrective Action Assigned, as follows.'MPLEMENTATION DUE DATE 2.
Unresolved, because:
IMPLEMENTATION VERIFIED BY PEU INITIALS:
PLANT OR SEC.
MGR.
MANAGER - QA SERVICES DATE FORWARDED CONFERENCE RESULTS 1.
Corrective Action Assigned, as follows.'MPLEMENTATION DUE DATE
= ~
E 2.
Unresolved, because:
IMPLEMENTATION VERIFIED BY PEU h
h ~
TNZTZALE:
DEPARTMENT NANAGER MANAGER, CORPORATE QUALITY ASSURANCE DATE FORWARDED CQAD 80-1 Page 44 of 48 Rev.
14
, ~
-t
. 'h Kh h hh a'
ENCLOSURE 8
Sheet 2 of 2 CORRECTIVE ACTION REQUEST No ~
(To Be Escalated)
AUDIT REPORT NO.
CAROLINA POWER 6 LIGHT COMPANY ITEM NUMBER CONFERENCE RESULTS 1.
Corrective Action Assigned, as follows:
IMPLEMENTATION DUE DATE 2.
Unresolved, because:
IMPLEMENTATION VERIFIED BY PEU INITIALS:
GROUP EXECUTIVE MANAGER - CORPORATE QUALITY ASSURANCE DATE FORWARDED FINAL RESOLUTION CORRECTIVE ACTION REQUIRED:
SIGNATURE:
SENIOR EXECUTIVE VICE PRESIDENT POWER SUPPLY AND ENGINEERING 6 CONSTRUCTION DATE DISTRIBUTION:
CQAD 80-1 Page 45 of 48 Rev.
14 0
ESCALATION FLOW CHART ENCLOSURE 0
NORMAL FLOW
.I UIQT NOHCOHFORMANCES (30 Days) a
RESPONSE
DUE DATE OmfiueNTS PEU SSUE CORRECTIVE ACTION REQUEST (TEN DAYS)
I+
I PEU REVIEW & EVALUATE PROPOSED CORRECTIVE ACTION EXTENS ION REQUEST TAKE CORRECTI VK ACTION PLANT/
SECTION MGR>>
UNRESOLVED MAHAGKR-QA SERVICES NOTIFICATION PROMPTLY CONFERENCE WITHIN 10 DAYS h
CORRECTIVE ACTION COMPLETIO UNACCEPTABLE DATE COMPLETIOH PKU MONITOR DEPT.
MGR.
CONFERENCE MGR. - CQA VERIFY COMPLETION CCEP TABLE OF CORRECTIVE ACTIO COMPLETION UNRESOLVED NOTIFICATION PROMPTLY CONFERENCE WITHIN 10 DAYS ACCEPTABLE COMPLETION CONFERENCE GROUP EXEC.
MGR.
CQA UNRESOLVED CONFERENCE WITHIN 5 DAYS CLOSE:
AUDIT HOHCONFORMANCES PIHAL DECISXOH SEPEOR EXECUTIVE VICE PRESNEsST CQAD 80-1 Page 46 of 48 Rev. I4
ENCLOSURE 10 Meekly Audit Activity Report Date Lead Date Rept.
due Rept. appr.
O~r anlzation Auditor Conducted Sec.
N r.
Sec.
H r.
Issued Resp.
Resp.
Reply Reply Due Rec.
Due Sent Resarks Distribution:
- Hanager, CLEAD
- Hanager, Qh Services
/AS Unit Reads Office Services Supervisor
9 III ~
9 REVISION 1
III. 1986 ACTI JLNOLRT PRMllART NARC'.
A S
IgmklUL AUDIT SCNRDOLR 2
tttR.
1986
~3l98&
JULY ADCUST APRIL IRT JONR OPRRATIRG FILNTS 4t h R.
198(9 SRPIlRRilk OCTORRR NOVRlQRR DR(XlNIR lklP (iA)
BNP (IB) 9 ~6
~
h 9
~ -
8 1
IOlP TiC) c 00 NNP o (2A) c BHP (2n)
CORSTROCTION INOIPICLTIONS RHP (2C)
NNP 73m)
BNP 4 (38)