ML20108C107

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Proposed Tech Specs,Relocating Administrative Controls Re QA Review & Audit Requirements of Section 6 from Plant TS to Boston Edison QA Manual
ML20108C107
Person / Time
Site: Pilgrim
Issue date: 05/01/1996
From:
BOSTON EDISON CO.
To:
Shared Package
ML20108C082 List:
References
NUDOCS 9605060174
Download: ML20108C107 (25)
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Attachment B Amended Technical Specification Paae # 6-7 l

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9605060174 960501 PDR ADOCK 05000293 P PDR

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ADMINISTRATIVE CONTROLS (Cont) 6.5 REVIEW AND AUDIT (Cont)

B. Nuclear Safety Review and Audit Committee (NSRAC) (Cont)

8. Audits Audits of facility activities shall be performed in accordance with the Boston Edison Quality Assurance Manual under the cognizance of the NSRAC.

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9. Authority l

The NSRAC shall report to and advise the Senior Vice President - Nuclear on those I l areas of responsibility specified in Section 6.5.B.7 and 6.5.B.8.

l l 10. Records Records of NSRAC activities shall be prepared, approved and distributed as indicated I below:

a. Minutes of each NSRAC meeting shall be prepared, approved and forwarded to the Senior Vice President - Nuclear, NSRAC members, and others the  ;

Chairman may designate. i l

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' "c.tlc.,177 Amendment No. 29, 30,1S, S9, 'i, SS,101,122,132,133 6-7 i

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l Attachment C Marked-up Technical Specification Pace # 6-7 1

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6.0 ADMINISTRATIVE CONTROLS (Cont) 6.5.. REVIEW AND AUDIT (Cont)

Nuclear Safety Review and Audit Committee (NSRAC) (Cont

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8. Audits [j, & #A

, p Onaas d Audits of facility activities shall be performe'o p H C Eh % nizance of

. the NSRA ese aualcs snali encu ass. 7

b. The conform ce of facility operat n to provisions contained within the Tec ical Specifications a applicable license conditions at lea once per year.
b. e training and quali ations of the entire t staff at least 1 o e per year.

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N The r sults of all actions requ d by deficiencies occur ' in 1

facili equipment, structures, sys ms or method of operatio l j that aff t nuclear safety at least o e per six months.

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d. The performa e of all activities required % the Quality '

Assurance Progkam to meet the criteria of Ap(pe dix "B",10 CFR 50, i at least once pk two years.

e. The Emergency Plan d implementing procedures at lea once per wo years.

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f. The tation Security Plan and implementing procedures at lea = l 2

once r two years.

g. Any other rea of facility oper . ion considered appropriate by the j NSRAC or th Senior Vice Presiden - Nuclear. '

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h. The Fire Protee on Program and implementing procedures at least '

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9. Authority 4 The NSRAC shall report to and advise the Senior Vice President - Nuclear on those areas of responsibility specified in Section 6.5.B.7 and ,

6.5.B.8. '

10. Records Records of NSRAC activities shall be prepared, approved and distributed as indicated below:
a. Minutes of each N3RAC meeting shall be prepared, approved and forwarded to the Senior Vice President - Nuclear, NSRAC members, and others the Chairman may designate.

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Revision 177 Amendment No. 29,-39 1 -46,-69 1 -74;-88 1 -104,-1221-132 1 -133 6-7

Attachment D Description of Chances to the Boston Edison Quality Assurance Manual A

- As required by 10 CFR 50.54 (a)(3), we are submitting changes made to the Boston Edison Quality Assurance Manual (DEQAM), Volume 11.

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[ The changes involve incorporation and revision of audit program requirements formerly

! contained in the technical specifications. We evaluated each change to determine if any .

requirements contained in the previously NRC approved QA program description were deleted i or made less stringent. Our evaluations concluded that some of these c'ianges result in l reductions in commitment. The identification of these changes, as well as the reasons and basis for continued compliance with 10 CFR 50 Appendix B, are provided in this attachment.

l Although some of the changes were considered to be reductions in commitment, overall, none of the changes made reduced the level of quality or compliance with 10 CFR 50 Appendix B.

Additionally, these QA program changes were made in accordance with the guidance provided  !

in NRC Administrative Letter 95-06," Relocation of Technical Specification Administrative l Controls Related to Quality Assurance". These changes are consistent with and satisfy the  !

I NRC position presented in the Administrative Letter.

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ATTACHMENT D i

I DESCRIIYTION OF CHANGES TO THE BOSTON EDISON QUALITY ASSURANCE MANUAL (BEQAM) l l INTRODUCTION The changes made to the BEQAM and presented in this submittal represent enhancements to the overall Quality Assurance Department (QAD) Oversight L

Program which consists of audits, surveillances, and reviews. The changes to each of these elements of the QAD Oversight Program is presented below.

SECTION 18. "AUD/TS' The changes to Section 18 include revisions to the Audit Program, enhancements to  :

Surveillance Monitoring requirements, and provides new requirements for the per- I formance of Program Reviews.

l IDENTIFICATION OF CHANGES i Changes to Paragraph 18.2.4 clarify and establish the BEQAM as the source for the frequency of NSRAC audits and delete the old references to the Technical Specifi- l cations for these requirements. These changes reflect the incorporation of the Nuclear Safety Review and Audit Committee (NSRAC) audit program which was previously contained in Section 6.5.B.8 of the Technical Specifications. Also, the statement reiterating compliance with the regulations, Regulatory Guides, and ANSI Standards contained in BEQAM Section 2 is redundant to actual Section 2 requirements and was deleted. l 1

l Changes to Paragraph 18.2.5 clarify BEQAM Section 18 as the source for audit program content. References to the Technical Specifications were deleted. These changes also reflect the incorporation of the NSRAC audit program which was pre-viously contained in Section 6.5.B.8 of the Technical Specifications.

Changes to Paragraph 18.3.1 establish the spaniffin requirements for audit program content. Audit subjects and their respective performance frequencies are now  :

classified as either once per 24 months (QA Program, Corrective Action, Training, '

Technical Specifications, Refueling, Fire Protection, and Conduct of Operations) or j once per 12 months (SNM, FFD, Fire Protection, and Security). These new 1 requirements differ from the previous Technical Specification Section 6.5.B.8  !

requirements in the following manner: l

1. The frequency of the Corrective Action Program audit changes from once per 6 months to once per 24 months.
2. The frequency of the Training and Quriification audit changes from once per 12 L

months to once per 24 months.

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3. The frequency of the Technical Specifications audit changes from once per 12 months to once per 24 months.
4. The frequency of the Station Security Plan audit changes from once per 24 months to once per 12 months.
5. The audit of the Emergency Plan once per 24 months changes to a Program Review performed on an annual basis.

Statements in Paragraph 18.3.1 concerning references to " Technical Specifications" and " auditing all elements of the QA Program at least every two years" become obsolete with the incorporation of the specific audit requirements above and, as such, are deleted.

In addition, changes to Paragraphs 18.1, 18.2.1, 18.2.2, 18.3.2, 18.4.1, 18.4.2, 18.5.1, and 18.5.3 and the addition of Paragraphs 18.2.6 and 18.5.4 are editorial in nature and are not considered part of the reductions in commitment.

The changes made in the Surveillance Monitoring process, involving Paragraphs 18.6.1 through 18.6.7, are enhancements to the overall QA Oversight Program and, therefore, not considered part of the reductions in commitment.

New paragraphs (18.7.1 through 18.7.8) were added to provide the general requirements for the performance of " Program Reviews." Program Reviews are another method by which QAD conducts oversight of specific activities utilizing surveillance monitoring. The Program Reviews involve a series of surveillances in a specific functional area over a designated time period. The results of Program Reviews are compiled, analyzed, and reported to senior management. The perform-ance of Program Reviews is an enhancement to the QA Oversight Program and, therefore, not considered part of the reduction in commitment.

REASONS FOR CHANGES The requirements for audit program content and frequency of performance are contained in several sources includog 10CFR, Technical Specifications, Regulatory Guides, ANSI Standards, and the BEGAM. This fragmentation of source require-ments creates an unnecessary burden on the commitment tracking process as well as reducing the effective utilization of rescarces by having to manage and monitor changes to a larger document base.

At the same time, the current audit prograrn requires audits to be performed regard-less of activities in progress, adhering to typically rigid schedules. Resources are consumed to meet time and specific subject requirements. This method of over-sight does not permit adjustment of schedale to focus resources more effectively oa areas of declining performance or, conversely, to reduce audit frequency in those areas of superior performance.

To address both issues above, the QA Oversight Program was revised to integrate j and schedule audits, reviews, and surveillances in a performance-based manner i which provides management with a continuous assessment of facility operation. I Specifically, the content and performance frequencies of the audit program were l revamped to introduce needed flexibility in QAD oversight activities. These audit program changes will permit reallocation of resources and more frequent audits or i l

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l surveillances in those areas of perceived or demonstrated weakness. This approach should have a positive impact on safety as resources are shifted to better focus on weak or declining areas while still providing periodic audit coverage in other stronger areas. The Program Review process was created to supplement changes in the audit program by providing a method to assess certain facility activities on a more frequent and ongoing basis via surveillance monitoring, with results summa-

rized and reported to senior management. These changes in the overall program j will also enable QAD to more broadly address spontaneous or emerging issues in I support of QA Program and plant needs.

Another benefit of these changes provides for incorporation of the former NSRAC Technical Specification audit requirements into Section 18 of the BEQAM. This j consolidation of program requirements into one source eliminates redundant licens-ing requirements, simplifies licensing document configuration control, and thereby I reduces cost and manpower expenditures.

J1 ASIS FOR SATISFYING 10CFR50 APPENDIX B

, The changes made to the BEQAM are being processed conservatively in accordance

! with 10CFR50.54(a) as a reduction in commitment. The revised QA Program con-tinues to satisfy the criteria of 10CFR50 Appendix B. All of the audits previously covered by the Technical Specifications which involved 10CFR50 Appendix B and safety-related activities will continue to be performed. Audit schedules will con-( tinue to be reviewed annually and adjustments made where necessary. A maximum l interval has been set to ensure all audit areas receive periodic coverage. Excluding audits required by 10CFR which will be conducted at the specified frequency, the maximum audit interval is 24 months. The 24-month frequency for most audits will allow resource focusing based on performance and activities in progress, while assuring that each area will be audited at a minimum frequency. The 24-month frequency is consistent with industry standard audit requirements.

The revision and incorporation into the BEQAM of the audit program requirements formerly contained in the " Administrative Controls" section of the Technical Specifi-cations have been processed in accordance with the guidance contained in NRC Administrative Letter 95-06, " Relocation of Technical Specification Administrative Controls Re/ated to Quality Assurance." The justifications for the changes made in l l the audit program frequencies, as well as the entire QA Oversight Program, detailed l in this submittal are consistent with the NRC position presented in the " Reviews and i

Audit" section of the Administrative Letter.

As part of the reconciliation and justification for revising the audit requirements, it is also noted that audit program requirements are contained in Regulatory Guide 1.33, Rev. 2. BEQAM Section 2 requires compliance with Reg. Guide 1.33, Rev. 2, with-out exception. The audit requirements contained in Section 4 of the Reg. Guide are identical to the audit requirements contained in the Administrative Controls section of Technical Specifications. Therefore, the basis and justification provided for the audit program changes in this submittal are also intended to envelope the audit requirements contained in the Reg. Guide.

Additionally, the Reg. Guide endorses the QA Program requirements of ANSI N18.7 l

1976. BEQAM Section 2 also requires compliance with ANSI 18.7 without excep-tion. Section 4.5 of ANSI 18.7 identifies the subject areas which must be audited on a minimum two-year frequency. The audit program changes to Section 18 of 1

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1 the BEQAM incorporate the N18.7 areas with the following exception: those sub-ject areas listed in ANSI 18.7 which have overlapping audit requirements with 10CFR (i.e., Security, Emergency Plan, and Radiation Controls) will be evaluated by the method and frequency specified by those regulations. This approach is consis-  !

tent with the NRC position presented in Administrative Letter 95-06.

The basis for each specific change in the audit program requirements is provided below.

1. The results of actions taken to correct deficiencies occurring in the facility equipment or methods of operation that affect nuclear safety.

FROM: audit every 6 months TO: audit every 24 months i

This requirement will be satisfied on an ongoing basis via audits and surveil-

! lances of all functional areas. Each audit will evaluate the adequacy of correc-

] tive action (C/A) taken since the previous audit. Additionally, surveillances will l be performed, separate from the audit program, of selected portions of C/A l controls and implementation. A dedicated audit of C/A will be conducted every two years and will focus on the programmatic controls as well as any C/A l weaknesses identified in other functional area audits and surveillances. )

1 l The proposed change does not negatively impact the evaluation of the Correc-1 tive Action Program. A C/A audit will continue to be performed on a two-year i basis to assess the adequacy and effectiveness of the C/A Program. C/A will 1 i also be assessed on a continual basis via review of C/A issues in each audit I

and through surveillance monitoring. Also, another method of evaluation of

. plant performance involves the Self-Assessme.nt Program. Currently, the QAD 1 coordinates the overall self-assessment process for the Nuclear Division and

! conducts oversight of the implementation of the process. The Nuclear Division l Group responsible for administration of the plant Corrective Action Program

! conducts self-assessments on a routine basis to monitor and evaluate its proc-1 esses. Its self-assessment practices will be monitored by QAD to verify imple-mentation of the self-assessment process.

2. The training and qualification of the entire plant staff.

FROM: audit every 12 months TO: audit every 24 months This requirement will continue to be satisfied. Each functional area audit will incorporate verification of certain training and qualification criteria to provide continuous coverage and assessment. Additional oversight will be accom-plished utilizing the surveillance program to focus on emerging issues. An audit will be conducted every two years and focus on the overall training program-matic controls. Plant problem monitoring and trending data will provide the necessary indicators of declining performance and will enable QAD to focus resources and adjust audit frequencies to address areas of noted weakness.

Reducing the frequency of this audit will not adversely impact the effectiveness of the audits performed since a dedicated audit of the Training Program will Page 4 of 6

l continue to be performed and training verification criteria wil! be integrated into other audits and surveillances. Additionally, the self-assessment practices of the Nuclear Training Departments will be monitored by the QAD to verify

, proper implementation of the self-assessment process.

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l 3. The conformance of the facility operation to the provisions contained in the Technical Specifications and applicable license conditions.

, FROM: audit every 12 months l TO: audit every 24 months

This requirement is satisfied by verifying that any organization responsible for l

implementation of procedures associated with compliance to Technical Specifi-l cation surveillance requirements properly executes those responsibilities. This l activity includes review of completed surveillance test procedures as well as l

l witnessing of such tests and is evaluated on a continual basis via all QAD audits, reviews, and surveillances in those areas where Technical Specification l surveillance criteria apply. Monitoring of LER issuance will provide an indicator

! of performance in which to target additional oversight resources.

Reducing the frequency of this audit from svery 12 months to every 24 months l will not adversely impact compliance with provisions of the Technical Specifi-cations, FSAR commitments, or the effectiveness of the audits performed.

l Compliance with Technical Specification surveiUance requirements and license l conditions is evaluated on a continuing basis in various functional area audits

! and surveillances in addition to a dedicated audit overy two years as a mini-l mum. Additionally, those organizations of the Nuclear Division responsible for l self-assessments in the area of Technical Specification surveillance perform-ance will be monitored by the QAD to verify proper implementation of the self-assessmer.t process.

l 4. The Station Security Plan and implementing procedures.

FROM: audit every 24 months TO: audit every 12 months This requirement will continue to be satisfied via the existing audit process and to the same level of detail and scope. The audit frequency has been changed

! to reflect 10CFR73.55 and 10CFR50.54 requirements regarding an audit of this t

area every 12 months.

Increasing the audit frequency from every 24 months to every 12 months does not adversely impact compliance with FSAR commitments or the effectiveness of the audits performed. This change eliminates redundant audit program requirements between the Technical Specifications and the above 10CFR soc-tions. Additionally, Security self-assessment practices will be monitored by the QAD to verify proper implementation of the self-assessment process.

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5. The Emergency Plan and implementing procedures.

FROM: audit once per 24 months TO: annual review This requirement is satisfied via performance of Program Reviews. Program Reviews involve a series of dedicated, scheduled surveillances which will evaluate the adequacy of key elements of the Emergency Plan and procedures over a 12-month period. At the conclusion of the review period, a comprehen-sive report will be issued to senior management providing a summary of the j

surveillance results as well as conclusions reached from analysis of those results. Oversight areas and frequencies will also be adjusted to respond to i l noted areas of weakness or improvement.

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! This proposed change does not adversely impact compliance with FSAR l

commitments or the effectiveness of the oversight performed in this area. This change reconciles overlapping requirements between the Technical Specifica-tions and 10CFR50.54(t). Performance of annual reviews is consistent with 10CFR50.54(t) regarding evaluation of Emergency Preparedness programs and procedures. The frequency requirement has been increased while the method of oversight provides for incremental monitoring of the same key elements of the EP Program previously covered by the audit program. The Program Review process will permit more real-time assessments and provide flexibility in adjust-ing resources and schedules to monitor areas of declining performance. Addi-tionally, monitoring of the EP self-assessment process will be integrated into the QAD Program Review of EP to verify proper implementation of the self-assessment process.

! Identification of findings and reporting of annual Program Review results will be

! communicated in the same manner and to the same level of management as in  ;

l the audit process. '

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Attachment E Amended Boston Edison Quality Assurance Manual Paaes i

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RTYPE: H8.46 ATTACHMENT E

. l AUDITS 18.1 PURPOSE This section establishes requirements for an internal auditing program to i verify the implementation of and to assess the effectiveness of the Boston i Edison Quality Assurance Program. This section also provides the general requirements for other QAD oversight functions, including surveillance moni-toring and performance of program reviews.

18.2 GENERAL REQUIREMENTS 1

18.2.1 QAD performs audits of all activities to which this Quality Assur-ance Program applies. Activities to which the QA Program do not apply arc nudited to the extent necessary to assure proper and safe operat on of PNPS.

18.2.2 Formal QAD audits may be supplemented by surveillance monitor-ing to provide adequate assurance of program compliance and effectiveness. Surveillance monitoring sbail be performed in accordance with Section 18.6. ,

18.2.3 Audits are performed by qualified personnel, using checklists to evaluate conformance to specified requirements, as well as to assess program effectiveness. Auditors shall not 'have direct responsibility in the areas being audited. Technical Specialists shall be utilized, as deemoc' necessary.

18.2.4 Audit subject and frequency is based on the requirements of Para-graph 18.3.1. Additional or more frequent audits may be per-formed when significant changes or problems arise, and upon request by NSRAC or the Senior VP, Nuclear. l 18.2.5 Audits required by this Section are performed under the cog-nizance of the Nuclear Safety Review and Audit Committee 1 l (NSRAC).

18.2.6 Audit results, including findings, shall be documented and distrib-uted to appropriate levels of management.

18.3 AUDIT PROGRAM ELEMENTS 18.3.1 An audit schedule is prepared annually. The schedule reflects the applicable regulatory, license, and QA Program requirements. The j audit program shall encompass, as a minimum, the following:

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l A. Once per 24 Months e The performance of activities required by the QA Program

. to meet the criteria of .10CFR50 Appendix B.

. The results of corrective actions taken to correct defi-ciencies in the facility equipment, st.ructures, systems, or methods of operation that affect nuclear safety.

  • The trainirg and qualification of the entire unit staff. l e The conformance of facility operation to the provisions i

contained within the Technical Specifications (Tech Specs)  ;

and applicable license conditions. I e The Fire Protection Program and implementing procedures.

  • Refueling activities and procedures.

1 e Conduct of operations and implementing procedures.  ;

e Any other area of facility operation considered appropriate by the NSRAC or the Senior Vice President, Nuclear. i B. Once per 12 Montha e The Special Nuclear Material Control Program and imple-menting procedures.

  • The Station Securit/ Plan and implementing procedures.

. The Fire Protection equipment and program implementation, utilizing either qualified off-site licensee personnel or an outside fire protection firm. An outside independent fire protection consultant shall be used at least every third year.

. Any other area of facility operation considered appropriate

. by NSRAC or the Senior Vice President, Nuclear.

18.3.2 Prior to each audit, a written audit plan is issued which identifies the audit scope and schedule, reference documents, organizations

, to be audited, and procedures or checklists. l 1 i l 18.3.3 Management of the audited organization (s) is notified in writing '

prior to each audit. The audit notification includes the audit scope,

}. the audit schedule, and identifies the audit team.

f 18.3.4 Prior to the start of each cudit, a pre-audit conference is con-

ducted with the audited organization (s) to confirm the audit scope, introduce the audit team, and establish channels of communica- l

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18.3.5 Audits are conducted utilizing checklists as a guide. Additional attribetes may be added as conditions dictate. The audit process includes review of objective evidence, and utinzes performance-based auditing techniques such as personal interviews and the witnessing of activities, if possible, to assess overall program effectiveners.

18.3.6 Where applicable, the audit includes a review of findings from previous audits in the area to assess the status of ongoing correc-tive actions and the effectiveness of completed corrective and  ;

preventive actions. i 18.3.7 At the conclusion of the audit, a formal post-audit conference is '

held with management of the audited organization (s) to discuss the audit results and present the audit findinr;s.

l 18.4 AUDIT REPORTS i l

18.4.1 All QA audits are followed by an Audit Report, signed by the audit team leader, within 30 working days of completion of the audit. l 18.4.2 The Audit Report includes, as a minimum:

  • Audit scope.

e Identity of the audit team, as well as key personnel contacted during the audit.

  • Summary of the audit results, including an evaluation statement regarding the overall effectiveness of the area and organi-zation(s) audited.
  • A description of deficiencies, as well as recommendakions for improvement identified during the audit.
  • Audit Reports shall be addressed to the Senior Vice President, Nuclear, with copies distributed, as a minimum, to:
  • Management of the audited organization (s),
  • QA Department Management, e NSRAC Coordinator.

l 18.5 AUDIT FINDINGE 1

! 18.5.1 Findings identified during QA audits are documentea on the l

appropriate corrective action document (refer to Section 15 or 16

. of this manual).

f j 18.5.2 Audit findings are discussed, as they are identified, viith manage-

ment of the audited organization (s).

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18.5.3 Organizations responsible for identified audit findings are required to respond within specified time limits. Responses are required to address the actions specified by the finding.

! 18.5.4 QAD performs follow-up activities for significant audit findings, to l include verification of the effectiveness of stated corrective l actions. Such follow-up activities shall be documented.

18.6 SURVEILLANG MONITORING PROGRAM l 18.6.1 QAD performs surveillances of selected NuOrg activities to assess l compliance with and performance to regulatory, license, and QA l Program requirements. Surveillance monitoring may also be per-l formed on non-safety-related activities or equipment, at the discre-l tion of QAD management.

l 18.6.2 Surveillances are intended to be narrowly-focused, short-duration evaluations which may involve direct observation of ongoing activities or reviews of con pleted records. Surveillances shs;l be of sufficient detail as to assess the performance and/or effective-

ness of the subject area or activity adequately.

18.6.3 Surveillances shall be performed in accordance with written proce-i dures tuhich provide instructions on surveillance planning, perform-ance, and reporting as a minimum.

l 18.6.4 Surveillances shall be performed by personnel qualified in accor-l dance with approved procedures.

l 18.6.5 Surveillance monitoring shall be both planned and unplanned in i

order to evaluate personnel and equipment performance under changing plant conditions.

l 18.6.6 Results of surveillance monitoring activities shall be documented.

Reports shall include, as a minimum:

  • Identification of subject area;
  • Surveillance scope;
  • Summary of results, including descriptions of findings.

Reports shall be distributed to the appropriate levels of manage-ment of the affected area.

18.6.7 Surveillance findings shall be recorded and processed in accor-dance with the appropriate corrective action document specified in l Sections 15 or 16 of this manual.

18.7 PROGRAM REVIEWS i

i' 18.7.1 QAD performs reviews of selected facility programs in order to verify compliance with applicable regulatory, license, and Station a requirements. Reviews consist of a series of surveillances which 11- 1 8 - 1 Rev.30  ;

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are designed to evaluate key elements of a specific program, in-crementally, over a designated period of time. At the conclusion of.the review period, the results of the individual surveillances are compiled and collectively evaluated for presentation in report for-mat to upper management.

18.7.2- The Program Review Subject List and schedule is prepared annu-ally. The content of the list, as well as the key elements of each subject, is reviewed periodically to assure that s>fficient coverage of the review subject will be achieved. As a minimum, the pro-gram review subject list shall encompass:

Every 12 Months e The program and implementing procedures for the processing, packaging, and shipping of radioactive wastes, j e The Radiological Environmental Monitoring Program (REMP).

  • The Radiation Protection Program and implementing procedures.

l 18.7.3 Program Review Oversight Plans shall be developed for . each .

review subject. These plans shall identify the key elements and attributes that must be verified during the review period in order to ensure sufficient coverage of a subject area. The content of the plans shall be derived from~ the applicable regulatory, license, and QA Program requirements. Also, content of the plans may be altered to reduce or ' increase the emphasis in those elements where exceptional or declining performance has been observed.

18.7.4 Program review periods shall be established for each review sub-ject, including beginning and end dates.

18.7.5 Program review su'rveillances shall be both planned and unplanned.

i Surveillance content shall include, as a minimum:

e identification of program review subject; e identification of Oversight Plan elements verified;

  • Summary of results, including description of findings and correc-tive action documents issued.

18.7.6 A Program Review Report shall be generated by QAD at the con-clusion of each subject review period. The report shall provide a summary of the subject surveillance results of the preceding period and a collective analysis of the overall results. The analysis of the overall results should focus on areas of declining performance and i adverse trends, as well as noted subject strengths and irnprove-l ments.

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18.7.7 Findings identified during the analysis of results shall be processed in accordance with Sections 15 or 16 of this manual, as appropri-l ate.

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18.7.8 Program Review Reports shall be issued within 30 working days of l

the end of the review period, i

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Attachment F Marked-up Boston Edison Quality Assurance Manual Paces l

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RTYPE: H8.46 ATTACHMENT F l . **

AUDITS 18.1 PURPOSE  !

This section establishes requirements for an internal auditing program to verify the implementation of and to assess the. effectiveness of the Boston Edison Quality Assurance Program. Audit: cf cupp!!c::' qu:!!ty :::uranee  ;

l p:cg::m: ::: =dd: ::cd in Secticn ?. This section also provides the general requirements for other QAD oversight functions, including surveillance moni- i toring and performance of program reviews.

l 18.2 GENERAL REQUIREMENTS l 18.2.1 QAD performs audits of all activities to which this Quality Assur-ance Program applies. Activities to which the QA Program do not  :

apply are audited to the extent necessary to assure proper c!:::!fi estion and safe operation of PNPS.

18.2.2 Formal QAD audits may be supplemented by surveillance monitor- .

i ing to provide adequate assurance of program compliance and  !

Surveillance monitoring shall be performed in effectiveness.

accordance with Section 18.6.

l l 18.2.3 Audits are performed by qualified personnel, using checklists to

! evaluate conformance to specified requirements, as well as to I

assess program effectiveness. Auditors shall not have direct responsibility in the areas being audited. Technical Specialists ,

shall be utilized, as deemed necessary.

18.2.4 Audit subject anc frequency is based on the requirements of Para-graph 1P. A.1:cgu!: lcnc, regu! : cry guidcs, :nd ANS! :: nd d; identifice in Secticn 2, : wc!! :: the PNPS Technic !

Specifications. Additional or more frequent audits may be per-formed when significant changes or problems arise, and upon men-gement request by NSRAC or the Senior VP, Nuclear.

18.2.5 Audits required by this Secticn S.O af-the PNPS Technica!

Specific: icn Section are performed under the cognizance of the Nuclear Safety Review and Audit Committee INSRAC).

18.2.6 Audit results, including findings, shall be documented and distrib-uted to appropriate levels of management.

i 18.3 AUDIT PROGRAM ELEMENTS i

l 18.3.1 An audit schedule is prepared annually. The schedule reflects i the:0 cudit: cqui:cd by Scotica 18.2.5, : minimum. The audit i schedu!: i: cviewed pericdic !!y te : urc that !! c!cment cf this i Qu !!!y A urance P cg := :: cudited : !cest Overy twc yearst s

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1 the applicable regulatory, license, and QA Program requirements.

l The audit program shall encompass, as a minimum, the following:

A. Once oer 24 Monthe l

  • The performance of activities required by the QA Program I to meet the criteria of 10CFR50 Appendix B.
  • The results of corrective actions taken to correct defi-ciencies in the facility equipment, structures, systems, or methods of operation that affect nuclear safety.
  • The training and qualification of the entire unit staff.
  • The conformance of facility operation to the provisions contained within the Technical Specifications (Tech Specs) and applicable license conditions.
  • Refueling activities and procedures.
  • Conduct of operations and implementing procedures.
  • Any other area of facility operation considered appropriate by the NSRAC or the Senior Vice President, Nuclear.

f B. Once oer 12 Months

  • The Station Security Plan and implementing procedures.
  • Tho Fire Protection equipment and program implementation, utilizing either qualified off-site licensee personnel or an outside fire protection firm. An outside independent fire protection consultant shallbe used at least every third year.
  • Any other area of facility operation considered appropriate l by NSRAC or the Senior Vice President, Nuclear.

i 18.3.2 Prior to each audit, a written audit plan is issued which identifies the audit scope and schedule, reference documents, organizations j to be audited, cudit schedule, and procedures or checklists. l 18.3.3 Management of the audited organization (s) is notified in writing prior to each audit. The audit notification includes the audit scope, the audit schedule, and identifies the audit team.

. 18.3.4 Prior to the start of each audit, a pre-audit conference is con-

, ducted with the audited organization (s) to confirm the audit scope,

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i J introduce the audit team, and establish channels of communica-tion.

18.3.5 Audits are conducted utilizing checklists as a guide. Additional  :

attributes may be added as conditions dictate. The audit process l includes review of objective evidence, and utilizes performance-based auditing techniques such as personal interviews and the witnessing of activities, if possible, to assess overall program effectiveness.

18.3.6 Where applicable, the audit includes a review of findings from previous audits in the area to assess the status of ongoing correc-  :

tive actions and the effectiveness of completed corrective and  !

preventive actions.

18.3.7 At the conclusion of the audit, a formal post-audit conference is held with management of the audited organization (s) to discuss the

- audit results and present the audit findings.

18.4 AUDIT REPORTS 18.4.1 All QA audits are followed by an Audit Report, signed by the audit l team leader, within 30 working days of completion of the audit. l 18.4.2 The Audit Report includes, as a minimum:

l e Audit scope.

e Identity of the audit team, as well as key personnel contacted during the audit.

  • Summary of the audit results, including an evaluation statement l regarding the overall effectiveness of the area and organi-l zation(s) audited.
  • A description of deficiencies, as well as recommendations for j improvement identified during the audit.

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  • Audit Reports ere- shall be addressed to the Senior Vice President, Nuclear, with copies distributed, as a minimum, to:

l e Management of the audited organization (s),

e QA Department Management, e NSRAC Coordinator, i

i 18.5 AUDIT FINDINGS  !

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! 18.5.1 Findings identified during QA audits cnd curvei!!cnccc are docu- l i mented on the appropriate corrective action document (refer to j Section 15 or 16 of this manual).

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A 18.5.2 Audit findings are discussed, as they are identified, with mant.ge-i ment of the audited organization (s).

i 18.5.3 Organizations responsible for identified auditisurvci!! nce findings are required to respond 10 OAD within specified time limits.

Responses are requimd to address the actions specified by the finding.

18.5.4 QAD performs foHow-up activities for significant audit findings, to include verification of the effectiveness of stated corrective actions. Such foHow-up activities shah be documented.

l 18.6 PERFORMANCE FOR SURVEILLANCE MONITORING PROGRAM l 18.6.1 GAO perform survci!!:nce monitoring of the activ!!!cs re!sted to the Station Organization and it: cupporting crganization: 10 : sess comp!! nce te!!h cetab!! hed Ou !!!y A urance Program require-mente, written pc!!cico, procedurce, instructions, directivcc, Ocdcs, standards, specifications, and centrc! documents. Surveillanees l can be performed by dircct Observation er rceerd revicw. Survci!

. !anccc cha!! be planned and unplanned, sc!cctivc!y and randomly, 1

and with sufficicnt detti! 10 cffectivc!y monitor and report the conditia at the Pilgrim Nuc! car Power Station and at the support ing facilitics.QAD performs surveiHances of selected NuOrg activities to assess compliance with and performance to regulatory, license, and QA Program requirements. SurveiHance monitoring may also be performed on non-safety-related activities or equipment, at the discretion of QAD management. l 18.6.2 O! crepancic noted during curve!!! nce monitoring cha!! be recorded on a Ocficiency Report tracked and dicpositioned ucing appicycd proccdurcs.SurveiHances are intended to be narrowly-focused, short-duration evaluations which may involve direct observation of ongoing activities or reviews of completed records.

SurveiHances shah be of sufficient detail as to assess the performance and/or effectiveness of the subject area or activity adequately.

18.6.3 SurveiHances shah be performed in accordance with written proce- ,

dures which provide instructions on surveiHance planning, perform- '

ance, and reporting as a minimum.

18.6.4 SurvoiHances shah be performed by personnel qualified in accor-dance with approvedprocedures.

18.6.5 SurveiHance monitoring shah be both planned and unplanned in order to evaluate personnel and equipment performance under changing plant conditions.

18.6.6 Results of surveiHance monitoring activities shan be documented.

Reports shah include, as a minimum-1 1

  • Identification of subject area; l, I

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e' SurveiHance scope;

  • Summary of results, including descriptions of findings.

, Reports shah be distributed to the appropriate levels of manage-ment of the affected area.

18.6.7 SurveiHance findings shah be recorded and processed in accor-dance with the appropriate corrective action document specified in Sections 15 or 16 of this manual.

18.7 PROGRAM REVIEWS 18.7.1 QAD performs reviews of selected facility programs in- order to l verify compliance with applicable regulatory, license, and Station ,

. requirements. Reviews consist of a series of surveiHances which i are designed to evaluate key elements of a specific program, in-crementaHy, over a designated period of time. At the conclusion of the review period, the results of the individual surveiHances are compiled and coHectively evaluated for presentation in report for-mat to upper management. l 18.7.2 The Program Review Subject List and schedule is prepared annu- )

aHy. The content of the list, as weH as the key elements of each j' subject, is reviewed periodicaHy to assure that sufficient coverage of the review subject wiH be achieved. As a minimum, the pro- 1 gram review subject list shah encompass- '

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. Everv 12 Months  :

  • The program and implementing procedures for the processing, '

packaging, and shipping of radioactive wastes.

  • The Radiological Environmental Monitoring Program (REMP).
  • The Radiation Protection Program and implementing procedures.  ;

18.7.3 Program Review Ovctsight Plans shah be developed for each review subject. These plans shah identify the key elements and attributes that must be verified during the review period in order to ensure sufficient coverage of a subject area. The content of the i plans shah be derived from the applicable regulatory, license, and.  ;

QA Program requirements. Also, content of the plans may be i

altered to reduce or. increase the emphasis in those elements where exceptional or declining performance has been observed.

l 18.7.4 Program review periods shan be established for each review sub-jec:, including beginning and end detes.  !

i 18.7.5 Program review surveiHances shah be both planned and unplanned.

SurveiHance content shah include, as a minimum:

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  • Identification of program review subject;
  • Identification of Oversight Plan elements verified;
  • Summary of results, including description of findings and correc-tive action documents issued.

18.7.6 A Program Review Report shall be generated by QAD at the con- \

clusion of each subject review period. The report shall provide a i summary of the subject surveillance results of the preceding period and a collective analysis of the overall results. The analysis of the ,

overall results should focus on areas of declining performance and l l

adverse trends, as well as noted subject strengths and improve-ments.

18.7.7 Findings identified during the analysis of results shall be processed '

in accordance with Sections 15 or 16 of this manual, as appropri-ate. '

18.7.8 Program Review Reports shall be issued within 30 working days of the end of the review period.

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