ML13303B524
| ML13303B524 | |
| Person / Time | |
|---|---|
| Site: | Oconee, Mcguire, Catawba, McGuire  |
| Issue date: | 10/07/2013 |
| From: | Waldrep B Duke Energy Carolinas |
| To: | Document Control Desk, Office of Nuclear Reactor Regulation |
| References | |
| Download: ML13303B524 (69) | |
Text
Benjamin C. Waldrep 526 South Church Street DUKE Charlotte, NC 28202" ENERGY, Mailing Address: Mail Code EC07H/P.O.
Box 1006 Charlotte, NC 28201-1006 704-382-6056 fax October 7, 2013 U. S. Nuclear Regulatory Commission ATTENTION:
Document Control Desk Washington, D. C. 20555-0001 Oconee Nuclear Station (ONS) McGuire Nuclear Station (MNS)Docket Nos. 50-269, 50-270, 50-287 Docket Nos. 50-369, 50-370 Catawba Nuclear Station CNS Oconee Nuclear Station Docket Nos. 50-413, 50-414 Docket Nos. 50-269, 50-270, 50-287
Subject:
Duke Energy Carolinas, LLC (Duke Energy)Quality Assurance Program Topical Report Amendment 40 Ladies and Gentlemen, Pursuant to 1OCFR50.54(a)(3) and 1OCFR50.71(e), attached is Amendment 40 to the Duke Energy Carolinas Topical Report, Duke-I -A, Quality Assurance Program (hereafter referred to as Topical Report). Amendment 40 includes organizational changes and administrative, clarification, and editorial changes.Duke Energy has completed an evaluation of each of these changes in accordance with provisions of 1 OCFR50.54(a)(3).
Amendment 40 contains no reduction in commitment addressed by the Topical Report. The results of the Duke Energy evaluation are summarized in Attachment 1, providing a description, reason, and basis for each change since the last update, which was submitted to the NRC October 10, 2011.Since NRC approval is not required for these changes, Amendment 40 was implemented September 30, 2013 and is provided for information as Attachment
- 2. The changes are shown by the use of indicator bars on the margin of affected pages.Please direct your questions on this matter to G. S. Kent at (980) 373-6032 (Gregory.
Kent@duke-energy.com).
There are no regulatory commitments associated with this letter.
U.S. Nuclear Regulatory Commission 4-.October 7, 2013 Page 2 I certify that all statements and matters set forth herein are true and accurate to the best of my knowledge and that the information represents changes made to the Duke Energy Carolinas Quality Assurance Program Topical Report, Duke-i-A, since the previous submittal.
Sincerely, blýýC1A142 Benjamin C. Waldrep VP Nuclear Corporate Governance
& Operation Support Attachments
- 1. Quality Assurance Program Topical Report Discussion of Changes 2. Quality Assurance Program Topical Report, Duke-I-A, Amendment 40: ,. ,-* 1, .. .,: ..ww.duke-en y.xom U. S. Regulatory Commission October 7, 2013 Page 3 xc: V. M. McCree, Regional Administrator U.S. Nuclear Regulatory Commission
-.Region II Marquis One Tower 245 Peachtree Center Ave., NE Suite 1200 Atlanta, Georgia 30303-1257 J. C. Paige, Project Manager (CNS & MNS)U.S. Nuclear Regulatory Commission 11555 Rockville Pike Mail Stop 8 G9A Rockville, MD 20852-2738 R. V. Guzman, Project Manager (ONS)U.S. Nuclear Regulatory Commission 11555 Rockville Pike Mail Stop 8 C2 Rockville, MD 20852-2738.
E. L. Crowe NRC Senior Resident Inspector Oconee Nuclear Station J. Zeiler NRC Senior Resident Inspector McGuire Nuclear Station G. A. Hutto NRC Senior Resident Inspector Catawba Nuclear Station Attachment 1 Discussion of Changes Duke Energy Carolinas Topical Report, Duke-I-A Quality Assurance Program, Amendment 40 Attachment 1 Duke Energy Carolinas Topical Report, Duke-i -A Quality Assurance Program, Amendment 40 Discussion of Changes Page 1 of 4 Purpose The purpose of this attachment is to identify the changes, the reason for the change, and the basis for concluding that the revised program incorporating the change continues to satisfy the criteria of Appendix B of 10 CFR Part 50 and the quality assurance program description commitments previously accepted by the NRC. The evaluation is consistent with the provisions contained in NRC regulation 10 CFR 50.54(a).
The changes do not represent a reduction in commitment and have been implemented.
Discussion The following changes to the Duke Energy Carolinas Topical Report have been made since the last update. Change bars in the margin of the affected pages indicate the changes.Change 1
Description:
Organizational description in Section 17.3.1.2 was revised to reflect changes resulting from the merger between Duke Energy and Progress Energy and to incorporate subsequent organizational changes.The merger related changes were communicated to the NRC in late 2011 prior to the merger. These changes included:* The change removed the Chief Nuclear Officer (CNO) responsibility for generation by non-nuclear facilities but added has responsibility for four nuclear sites (Brunswick, Crystal River 3, Shearon Harris, and Robinson).
Those four sites do not come under this description of the Quality Assurance Program. (17.3.1.2.2.b)" The Nuclear Oversight executive reports directly to the CNO instead of reporting to the Nuclear Corporate executive.
In addition to the oversight functions, the Nuclear Oversight executive is responsible for the Employee Concerns, which previously reported to the Nuclear Corporate executive.
(17.3.1.2.2.a)
- The Nuclear Engineering executive reports directly to the CNO instead of reporting to the Nuclear Corporate executive.
Nuclear Engineering adds new responsibilities for document control, records management, and computer applications replacing the quality assurance program aspects of the services previously provided through Department Interfaces with Enterprise Operations Services, Generation Support, and Information Technology.
(17.3.1.2.2.a)" The term Nuclear Corporate has been replaced with Corporate Governance and Operations Support. The executive for this area continues to report directly to the CNO. (17.3.1.2.2.a)" Changes to Department Interfaces (17.3.1.2.3):
o Enterprise Operations Services was removed with Nuclear Engineering assuming responsibility for document control and records management.
o Generation Support is replaced by Finance for the decommissioning related activities.
The remaining functions previously provided by Generation Services have been assumed by Nuclear Engineering.
o Human Resources continues to support, but no longer administers, the Access Authorization, Fitness for Duty, and Fatigue Rule programs.* The typical Site Organization is revised as follows (17.3.1.2.2.b):
o The Station Manager is changed to Plant Manager o Safety Assurance is changed to Organizational Effectiveness Attachment 1 Duke Energy Carolinas Topical Report, Duke-i-A Quality Assurance Program, Amendment 40 Discussion of Changes Page 2 of 4 o Engineering, Security, and Major Projects all have On-Site organizations with a manager reporting to the site Vice President; however, governance for these is provided by the associated off-site nuclear executive.
Additional editorial changes were made throughout the document replacing the acronym"INOS" with "NOS" reflecting the new generic terminology.
In addition, an editorial change was made in Section 17.3.1 to replace the acronym DEC ("Duke Energy Carolinas" which constitutes the scope of applicability for this description of the QA Program) with Duke Energy where the organization description applies to the corporation.
Subsequently, the Organization Description in Section 17.3.1.2.2.a was revised to show Site Engineering as a Site organization instead of a part of corporate engineering as had been approved in the Merger Organization.
The Organization Description in Section 17.3.1.2 was next revised to identify a senior executive position between the Chief Executive Officer and the Chief Nuclear Officer. The Chief Nuclear Officer (CNO) remains the corporate executive responsible for quality assurance (QA) and remains the highest level of management responsible for establishing Duke Energy Carolina's QA policies, goals, and objectives.
The CNO has overall responsibility for Duke Energy's operating nuclear power plants. The CNO reports to a senior executive who is also responsible for the non-operational functions of nuclear plant development, nuclear plant decommissioning, and project management
& construction.
Additionally, Nuclear Oversight in Section 17.3.1.2.2.b is revised to clarify the continuing oversight responsibilities for nuclear plant development and decommissioning.
The final changes to the Organization Description were to reflect a new corporate executive assuming the roles and responsibilities associated with training and leadership development (17.3.1.2.2.a).
Those roles and responsibilities were previously assigned to Corporate Governance and Operations Support.Reason for these changes: The initial organization change was necessary for the completion of the merger between Duke Energy and Progress Energy. Subsequent changes were made based on benchmarking and to strengthen oversight and management of the operating fleet while maintaining focus on nuclear plant development and decommissioning.
Change 1
Conclusion:
The change in CNO responsibilities added four nuclear sites but removed non-nuclear generation facilities from the responsibility of the CNO. The number of direct reports to the CNO remains the same. This change will maintain or improve nuclear communication to the highest level within the company. Each of the four added nuclear sites has its own description of the Quality Assurance Program, which will continue to be applicable to that site. When performing QA Program related work for a given site, individuals will have to be qualified to the QA Program applicable to that site. This is not a change to the QA Programs.The change in reporting level for the executive responsible for Nuclear Oversight to a position directly reporting to the CNO maintains or enhances individual and organizational ability to perform QA functions.
It ensures continuing authority, organizational freedom, and Attachment 1 Duke Energy Carolinas Topical Report, Duke-i -A Quality Assurance Program, Amendment 40 Discussion of Changes Page 3 of 4 independence to ensure that cost and schedule pressures do not compromise quality or nuclear safety considerations.
None of the organizational changes constitute a reduction in any commitment currently contained within the Duke Energy Carolinas Quality Assurance Program. The organizational revisions ensure that persons and organizations performing quality assurance functions continue to have the requisite authority and organizational freedom, including sufficient independence from cost and schedule when opposed to safety considerations.
Change 2
Description:
This change revises definition for Quality Control Inspector in Section 17 to remove reference to industry standard SNT TC 1 A. The commitment to the qualification standard is documented in Topical Report Table 17-1 for Regulatory Guide 1.58, which is not changed. A similar change is made in Section 17.3.2.12, inspection replacing the standards previously identified with a reference to Table 17-1.Reason for this change: These are administrative improvements and clarifications or editorial corrections to reduce repetition within the document.Change 2
Conclusion:
These changes are administrative improvements and clarifications, or editorial items as defined in 10CFR50.54(a)(3).
These items are all considered corrections or editorial clarifications of existing descriptions within the Duke Energy Carolinas Quality Assurance Program. These changes do not constitute a reduction in any commitment currently contained within the Duke Energy Carolinas Quality Assurance Program nor do they result in a change to Duke Energy Carolinas' current practices.
Specifically, the correct standard for inspector qualification is and has been identified in the QATR commitments in Table 17-1 Change 3
Description:
This change revises the text in section 17.3.2.14 to provide generic references to controlled nuclear department manual(s) rather that appearing to specifically require a "Nuclear Policy Manual." Reason for this change: The change is made to improve consistency and add administrative clarifications on requirements.
Change 3
Conclusion:
The changes in this section are administrative improvements and clarifications, or editorial items as described in 10CFR50.54(a)(3).
These items are all considered to be clarifications of existing descriptions within the Quality Assurance Program and to enhance consistency with the description in Topical Report Section 17.3.2.1.
These changes do not constitute a reduction in any commitment contained within the Quality Assurance Program, removing the appearance of a specific name (Nuclear Policy Manual)for the manual containing the controlled procedures.
The controls applied to the procedures remain the same. Additionally, these changes do not result in a change to our current practices.
Change 4
Description:
The definition of QA Condition 3 in the Introduction is revised to remove the reference to the Hazards Analysis and simply reference satisfaction of 1 OCFR 50.48 consistent with Oconee license amendment for NFPA 805 implementation.
Attachment 1 Duke Energy Carolinas Topical Report, Duke-i -A Quality Assurance Program, Amendment 40 Discussion of Changes Page 4 of 4 Reason for this change: The change is in response to the Oconee license amendment for implementation of NFPA 805.Change 4
Conclusion:
This change simplifies the definition of QA Condition 3 to clearly apply to SSCs identified as important to Fire Protection including those under the new NFPA 805 implementation at Oconee and to continue to apply to SSCs identified under the more prescriptive fire hazards analyses at Catawba and McGuire. This is not a reduction of commitments as it implements the NRC approved License Amendment Request (LAR) at Oconee for the application of NFPA 805.
Attachment 2 Duke Energy Carolinas Topical Report, Duke-I-A Quality Assurance Program, Amendment 40 DUKE ENERGY CAROLINAS TOPICAL REPORT Quality Assurance Program DUKE-1-A ABSTRACT This topical report describes the Duke Energy Carolinas Quality Assurance Program (QAP) for the operational phase of its nuclear power plants. The report is organized like and is generally used for Chapter 17, "Quality Assurance" of each of the Duke Energy Carolinas nuclear station's Updated Final Safety Analysis Reports (UFSAR).The Duke Energy Carolinas QAP conforms to applicable regulatory requirements such as 1 OCFR 50, Appendix B and to approved industry standards such as ANSI N45.2-1977 and ANSI N18.7-1976 and corresponding daughter standards, or to equivalent alternatives.
The Duke Energy Carolinas QAP also conforms to the regulatory position of the NRC Regulatory Guides listed in Table 17-1 of this report with the exception of the clarifications, modifications, and alternatives stated therein.The Duke Energy Corporation QAP Policy Statement, issued by the President and Chief Executive Officer, describes the corporate policy and assigns responsibility for implementation of the QAP.Section 17, "Quality Assurance", Introduction describes the purpose of this report, provides definitions, and shows conformance to regulations, standards, and guides.Section 17.3, "QAP Description" describes the QAP and organization for station operation.
Section 17.3, "QAP Description" follows the format of NUREG-0800, "Standard Review Plan For The Review of Safety Analysis Reports for Nuclear Power Plants", Section 17.3, "QAP Description," except that the Duke Energy Carolinas QAP is based on ANSI N 18.7-1976 in lieu of ANSI/ASME NQA-1 and NQA-2.The topical is intended to be a comprehensive up-to-date description of Duke Energy Carolinas QAP for nuclear power plants.Hl Amendment 40 Table of Contents 17. QUALITY ASSURANCE
...............................................................................................
I INTRODUCTION
........................................................................................................................
1 DEFINITIONS
..............................................................................................................................
2 EXPLANATION OF "QUALITY ASSURANCE".
..................................................................
3 QA STANDARDS AND GUIDES ...........................................................................................
3 17.1 QA DURING DESIGN AND CONSTRUCTION
....................................................
,.. 15 .17.2 OPERATIONAL QA ............................................
15 17.3 QUALITY ASSURANCE PROGRAM (QAP) DESCRIPTION
.........................................
I...16 17.3.1 Management
............................................
16.17 .3.1.1 M ethod ology .....................................................................................................
...........................
16 17.3.1.2 O rganization
......................................................................................................
W ..........................
16 17.3.1.2.1 Corporate Organization
...........................
..................................................................
16 17.3.1.2.2 Nuclear Geneition:
........ :....................................................................................................
17 17.3.1.2.3 Department Interfaces
...............................
..............................
19 17.3.1..3.Responsibility.......................................................
19 17 .3 .1.3 R espo nsibility
.......................................
I........................................................................................
19 17 .3.1.4 A utho rity .... ...................................................................................................................................
20 17.3.1.5 Personnel Training and Qualification
....................................................................................
20 17.3.1.6 Corrective Action ..........................................................................................................................
20 17.3.1.7 Regulatory Commitments
.......................................................................................................
20 17.3.2 PerformranceA/erification
...............................................................................
24 17.3.2.1 M ethodology
.................................................................................................................................
24 17.3.2.2 Design Control ...............................................................................................................................
24 17.3.2.3 Design Verification
....................................................................................................................
25 17.3.2.4 Procurement Control .....................................................................................................................
27 17.3.2.5 Procurement Verification
...........................................................................................................
29 17.3.2.6 Identification and Control of Items ..........................................................................................
30 17.3.2.7 Handling, Storage, and Shipping .........................................
31 17.3.2.8 Test C ontrol ........................................................................................
........................................
3 1, 17.3.2.9 Measuring and Test Equipment Control .................................................................................
33 17.3.2.10 Inspection, Test, and Operating Status ...................................................................................
34 17.3.2.11 Special Process Control .........................................................................................................
34 17.3.2.12 Inspection
.....................................................................................................................................
35 17.3.2.13 Corrective Action ..........................................................................................................................
36 17.3.2.14 Document Control ........................................................................................................................
38 17.3 .2.15 R ecords ........................................................................................................................................
4 1 17.3.3 Self Assessment
.............................................................................................
44 17.3.3.1 Methodology
.................................................................................................................................
44 17.3.3.2 Assessment
..................................................................................................................................
45 17.3.3.2.1 Nuclear Safety Review Board .............................................................................................
45 17.3.3.2.2 Plant Operations Review Committee
.................................................................................
46 17.3.3.2.3 Independent Nuclear Oversight
..........................................................................................
46 17.3.3.2.4 Corporate Audit ........................................................................................................................
49 Amendment 40 i1i List of Tables TABLE 17-1 CONFORMANCE OF DEC's PROGRAM TO QUALITY ASSURANCE STANDARDS, 'REQUIREMENTS AND GUIDES .........................................................................
..........
- ...IV Amendamt 40, List of Figures FIGURE 17-1. DUKE ENERGY CORPORATION QUALITY ASSURANCE POLICY STATEMENT
....... 21 FIGURE 17-2. CORPORATE AND OFFSITE ORGANIZATION
...............................
22 FIGURE 17-3. NUCLEAR SITE ORGANIZATION
.........................................................................
23 Amendment-40 v
vI AMendment 40 List of Effective Pages Page No.Title Page 17-ii 17-iii 17-iv 17-v 17-vi 17-vii 17-viii 17-ix 17-x Amendment No.40 40 40 40 40 40 40 40 40 40 17-1 17-2 17-3 17-4 17-5 Table 17-1 (Page 1 of 10)17-6, Table 17-1 (Page 2 of 10)17-7, Table 17-1 (Page 3 of 10)17-8, Table 17-1 (Page 4 of 10)17-9, Table 17-1 (Page 5 of 10)17-10, Table 17-1 (Page 6 of 10)17-11, Table 17-1 (Page 7 of 10)17-12, Table 17-1 (Page 8 of 10)17-13, Table 17-1 (Page 9 of 10)17-14, Table 17-1 (Page 10 of 10)17-15, 17-16 17-17 17-18 17-19 17-20 17-21 17-22, Figure 17-1 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 Page No.17-23, Figure 17-2 17-24, Figure 17-3 17-25 17-26 17-27 17-28 17-29 17-30 17-31 17-32 17-33 17-34 17-35 17-36 17-37 17-38 17-39 17-40 17-41 17-42 17-43 17-44 17-45 17-46 17-47 17-48 17-49 17-50 Amendment No.40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 40 I Amendment 40 VIII V.d 4 viii Amendment 40 LIST OF AMENDMENTS Number Original 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 Amendment Date March 1, 1974 October 1, 1974 (Complete Revision)February 14, 1975 November 22, 1976 June 29, 1978 July 14, 1981 February 3, 1983 June 22, 1984 May 20, 1985 July 30, 1985 October 17, 1986 November 12, 1987 March 30, 1989 April 18, 1990 August 23, 1991 August 7,1992 (Complete Rewrite)June 16, 1994 June 16, 1994 December 12, 1994 March 30, 1995 June 29, 1995 July 11, 1996 November 1, 1997 June 30, 1998 January 5, 1999 May 31, 1999 September 13, 2000 December 14, 2000 June 21, 2001 December 10, 2001 July 31, 2002 December 16, 2002 June 03, 2004 July 29, 2004 May 2, 2006 May 31, 2007 September 18, 2008 January 28, 2010 Number Amendment Date 38 August 17, 2010 (Reissue of Amendment 37 per NRC Safety Evaluation dated 08-17-10)39 September 30, 2011 40 September 30, 2013 I Amendment 40 ix Summary of Changes Changes since last NRC update at Amendment 39 Description of Change Organizational description in Section 17.3.1 was revised to reflect changes resulting from the merger between Duke Energy and Progress Energy.Additional editorial changes were made throughout the document replacing the acronym"INOS" with "NOS" reflecting the new generic terminology.
Editorial change in Section 17.3.1 to replace the acronym DEC ("Duke Energy Carolinas" which constitutes the scope of applicability for this description of the QA Program) with Duke Energy. The organization description applies to the whole corporation.
Per PIP G-12-01565 revised definition section for Quality Control Inspector to remove reference to SNT-TC-1A.
The commitment to the standards is documented in QATR commitment section, Table 17-1. Similar change is made on Page 17-37 to replace the standards with a reference to Table 17-1.Revised the text in section 17.3.2.14 to provide generic references to controlled nuclear department manual(s) rather that appearing to specifically require a "Nuclear Policy Manual." Org Description in Section 17.3.1.2.2 was revised to show the Site Eng Mgr reporting to Site VP instead of corporate engineering as had been approved in the Merger Organization (July 3, 2012 change to the QATR Amendment 39).Org Description in Section 17.3.1.2 revised to identify a senior executive position between the Chief Executive Officer and the Chief Nuclear Officer. The Chief Nuclear Officer (CNO) remains the corporate executive responsible for quality assurance (QA) and remains the highest level of management responsible for establishing Duke Energy Carolina's QA policies, goals, and objectives.
The CNO has overall responsibility for Duke Energy's operating nuclear power plants. The CNO reports to a senior executive who is also responsible for the executives of Nuclear Plant Development, Nuclear Plant Decommissioning, and Project Management
& Construction organizations.
Definition of QA Condition 3 in Section 17.0 Introduction revised for clarity of application and consistency with Oconee LAR for application of NFPA-805.Org Description in Section 17'3.1.2.2 was revised to divide the Corporate Governance and Operations Support responsibilities approved in the Merger Organization (July 3, 2012 change to the QATR Amendment
- 39) among two executives.
- .' , -, .X Amendment
- 40.
- 17. QUALITY ASSURANCE INTRODUCTION Duke Energy Carolinas (DEC) maintains full responsibility for assuring that its nuclear power plants are designed, constructed, tested and operated in conformance with good engineering practices, applicable regulatory requirements and specified design bases and in a manner to protect the public health and safety. To this end DEC has established and implemented a Quality Assurance Program (QAP) which conforms to the criteria established in Appendix.
B to Title 10 Code of Federal Regulations (1 OCFR), Part 50, "Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants" published June 27, 1970 (35 F. R. 10499), amended September 17, 1971 (36 F. R. 18301), amended January 20, 1975 (40 F. R.32100), and amended August 28, 2007 (72 F. R. 49505).This Topical Report is written in the format of a Safety Analysis Report (SAR) Chapter 17,"Quality Assurance", in accordance with Revision 2 of the Nuclear Regulatory Commission (NRC) Regulatory Guide 1.70, "Standard Format and Content of Safety Analysis Reports for Nuclear Power Plants -LWR Edition" and subsequent NRC guidelines.
The QAP described herein is applicable to DEC nuclear power stations as referenced by Chapter 17 of each station's UFSAR.This Topical Report describes the QAP for those systems, components, items, and services which have been determined to be nuclear safety related (QA Condition 1). In addition, the QAP provides a method of applying a graded QAP to certain non-safety related systems, components, items, and services.
These are classified as QA Conditions 2, 3, 4, or 5. This method involves defining a Quality Assurance (QA) "Condition" for each level of QA requhrel.These will be designated as "QA Condition
". The quality of systems, components,#itqms, and services within the scope of QA Conditions 1, 2, 3, 4, and 5 is assured commensurate with the system's, component's, item's, or service's importance to safety. The following ,ondfiton have been defined.QA Condition 1 covers those systems and their attendant components, items, ainc services.which have been determined to be nuclear safety related. These systems are detailed in Ae, Safety Analysis Report applicable to each nuclear station: The Topical Report applie"h ft"'.entirety to systems, components, items, and services identified as QA Condition.
.QA Condition 2 covers those systems and their attendant componentS, iteffS, anid strudk*important to the management and containment of liquid, gaseous, and solid roc~ioacti waste, QA Condition 3 covers those systems, components, items, anrd Wxvlces whio are Minorit to fire protection in addressing 10 CFR 50.48.QA Condition 4 covers those seismically designed/restrained aystems, 66#ýnm tsnd structures whose continued functions are r60 required-durin§ and atMr thwselenievefli.
The general scope of these systems, components, and structures, identified as Seismic Categwy 1!(SCII) are defined in Regulatory Guide 1.29, Seismic Design Classication. , .. ...QA Condition 5 covers those systems, components, items, and services which are imporIM tO the mitigation of design basis and other selected events.as defined in,applicat.
pro~edWes
.., and directives.
QA Condition 5 only applies to Oconee Nuclear Statiqn." Quality assurance program requirements for Oconee, , .M 're, and Cata dicask activities are performed in accordance with applicble 19CFR72,212 reportsfo h sil W invokes the NRC approved 10CFR50 Appendix B QAP as desacibetwo this Tgp.cal Report.Amendment 40 17-1 This Topical Report also provides the basis for the control and performance of 4fqet,related and quality related activities associated with new DEC nuclear plants until the .WAkwoves a'QA Program Description specific to the new units and the associated implementing procedures are in place. 'Subsequent changes to the DEC QAP shall be incorporated in this Topical Report. The Topical Report is intended to be a comprehensive up-to-date description of the DEC QAP for nuclear power plants.Any programmatic changes to the QAP that constitute a reduction in commitment will be submitted for review and acceptance prior to implementation.
Significant organizational.
changes will be submitted as required by 1OCFR50.54 (a) (3).DEFINITIONS The following definitions are applicable to terms used in this report. Terms used in this report which are not.defined in this section are defined in ANSI N45.2.10, "Quality Assurance Terms and Definitions." ADorover -An individual who reviews an activity for concept and conformity with codes and standards; the approver is a person other than the originator or checker.Audit (Intermal)
-An activity to determine through investigation the adequacy of, and adherence to, established procedures, instructions, specifications, codes, and other applicable contractual and ficenslho r0euirements, and the effectiveness of Implementation.
Basic C2mnet- See QA Condition I in previous section.Check r,-Ah individual, other than the originator or approver, who is qualified in the area being chedk10dnd:Who has the responsibility to check the activity and/or all revisions for coiittin ity, and accuracy.Do -T,*Th4icividal who performed the design.Deficiency
-Any condition considered to be adverse to quality including inadequacies of personne"iOul, methods, or items.`', M ften pictorial Information describing, defining, specifying, reporting, oro procedures, or results. Examples of documents are drawings, specifications, InW66eIm andprocedures significant to the design, construction, testing, maisPC! opowri. in ofQA Condition 1 equipment and systems.ErdjA6Wft!Chlf g g&- -A planned change in plant design accomplished in a land limitations of applicable codes, standards, specificatiOns, licenses and predetermined safety restrictions.
- X. A aOQU to provide a process by which field*vanationS from deqign * # er~ev*Wsed and permittedi........
iffte preparation, deýv mtf-, lstaNkttin 6W'construction,
- & tif6tý r6oes thatrt'equie tfsit or reglew by ldreflfibd component, part, or ." -" P ZpAj' 7r- *fIell,. ) petformed in a'cordande witt p uresore W Wdx ij)eAtieA Andtd 1 of e*encetat the nAP has been devek& d66iV~hted,'
"41thiteft~nted6b ac~wdathb with s~cf fld tekulremnerts.
17-2 A d \40 Amendment 40 Problem Investigation Process -A process used during the operation phase of nuclear stations that documents an occurrence, situation, or nonconformance that resulted in other than expected equipment performance, personnel action, or failure to operate within established limits.Quality Assurance (QA) -The planned and systematic actions necessary, to provide adequate confidence that a material, component, system or facility will perform satisfactorily in service.(Note: See Section 17, "Quality Assurance," Explanation of "Quality Assurance" below for further explanation.)
QA Records -Those records which furnishdocumentary evidence of the quality of items and of activities affecting quality.QA Requirements
-Those inspection, test, examination, certification and documentation requirements which are imposed to provide objective evidence of the conformance of an item or activity to established design, engineering, standards, and code requirements.
Quality Control (QC) -Those QA actions which provide a means to control and measure the physical characteristics of an item, process or facility.to established requirements.
Quality Control Inspector (Inspector)
-Any individual certified to the requirements identified in Table 17-1 for Regulatory Guide 1.58 who performs required inspections, tests or examinations.
Responsible Engineer -The engineer assigned responsibility for an item or service.Revisions
-Any addition, correction, deletion or change.Services -The performance by a supplier of activities such as calibration, design, investigation, inspection, nondestructive examination, software applications, and installation.
Supplier Audit -A documented activity performed in accordance with written procedures or checklists to verify, by examination and evaluation of objective evidence, that applicable elements of the QAP have been developed, documented and. implemented in accordance with specified requirements.
EXPLANATION OF "QUALITY ASSURANCE" QA as used in this document includes:
- 1) the independent assurance activities associated with items and tasks critical to the safety and integrity of the facility and 2) quality verifications performed by the Internal and Procurement Quality audit functions and by the Nuclear Safety Review Board in Nuclear Generation.
The QAP as defined above is not an altemative to good technical work. Rather, it is a system of controls to verify that quality is achieved.
The QAP places the responsibility on line management of achieving and assuring quality in all areas of their operation.
As defined, the Chief Nuclear Officer has been given the responsibility to develop and manage a QAP for the Corporation.
QA STANDARDS AND GUIDES The DEC QAP conforms to Appendix B of 1OCFR 50, as discussed in Section 17, "Quality Assurance." The QAP also conforms to applicable NRC Regulatory Guides and approved ANSI Standards, or applicable alternatives.
Table 17-1 addresses QAP conformance to the, referenced regulatory and program guidance contained in NUREG-0800.
QAP conformance with the documents identified in Table 17-1 may, however, be modified contingent upon future NRC or ANSI action. For example, if a draft document is subsequently approved and issued or if an approved document is revised, provisions of the more recent issue Amendment 40 17-3 of such a document may be complied with in lieu of those contained in the version, listed in Table 17-1, provided the more recent issue has been endorsed by the NRC. Also, formal regulatory actions of the NRC (e.g., issuance or amendment of a station's Facility Operating License) are considered to supersede the contents of Table 17-1, as applicable., '
- ii..... ..., .....'A,., '.,, y .g'I. ., *.. ..7 ['7 .'~;4% rl..iUi,¶1/22.
a '1.VVA bc~ ~'1...* P.Tb K;~ vr 7~'.-..*1, 17-4 Amendment 40 .
Table 17-1 Conformance of DEC's Program to Quality Assurance Standards, Requirements and Guides Standard, Requirement or Guide Conformance Remarks Status Regulatory Guide 1.8 Rev (1-R) -Alternative RG 1.8 Rev (l-R) incorporates ANSI N18.1. The DEC QAP Personnel Selection and Training conforms to ANSI N18.1-1971 or as otherwise stipulated in the Technical Specifications Regulatory Guide 1.26 Rev (3) -Quality Alternative The DEC QAP conforms to this Regulatory Guide except for Group Classifications
& Standards for additional details and directions noted in each station's UFSAR.Water, Steam, and Radioactive-Waste Containing Co"pone nts of Nuclear Power Plants Regulatory Guide 1.28 Rev (2) -QAP Conforms Requirements (Design and Construction)
Regulatory Guide 1.29 Rev (3) -Seismic Alternative The DEC QAP conforms to this Regulatory Guide except for Design Classification additional details and directions noted in each station's UFSAR.Regulatory Guide 1.30 Rev (0) -Quality Conforms RG 1.30 Rev (0) incorporates ANSI N45.2.4-1972 for both Assurance Requirements for the construction and operation Installation, Inspection and Testing of Instrumentation and Electric Equipment Regulatory Guide 1.33 Rev (2) -QAP Alternative RG 1.33 Rev (2) incorporates ANSI N18.7-1976/ANS-3.2.
The Requirements (Operations)
DEC QAP conforms to ANSI N 18.7-1976 except the frequency of audits of selected aspects of operational phase activities is defined in Section 17.3.3, "Self Assessment" and the frequency for procedure review, as described in Section 17.3.2.14,"Document Control," is based on ANSI/ANS-3.2 (1994) with appropriate reviews performed when the need is identified by normal use, unusual incidents, engineering changes, or established quality programs.
Review frequencies for Abnormal Pgocedures, Emergency Procedures, and Emergency Response Procedures shall not exceed six years. Procedures that have not been used for six years shall be reviewed prior to reuse.,....,.....,When pMui.r hiag *omrnrcia-gradj calibration services from Amendment 40 17-5 Tale171 on~we -eof DEC* PrognmU alft Murn",~nd Reii~~t nd uies Standard, Requirement or Guide Conformance Remarks Status .-cgttain accredited cafibration laboratoriesb the procurement documenta are trot reuired to impose a QAP consistent with ANSi N45.2-1977.
Alternate req rements described in the QA T*ou Report for Regulatory Guide 1.123 may be implemented in lieu of imposing a QAP consistent With'ANSI N45.2-1977.
A person with nondestructive testing experience is not required on the Nuclear Safety Review Board (NSRB) as required by section 4.3.1 of ANSI N18.7-1976.
The technical experience requirements for NSRB members were transferred from each... ..site's technical speccations and did not include a person with n.,destructive testing experience.
The transfer of NSRB requirements from each site's Technical Specification to the QA Topical Report was approved by an SER dated October 22, 1998 for amendment 23.The independent review of Technical Specification changes and license amendments shall be performed by the Plant Operations Review Committee (PORC). NSRB review and approval of Technical Specification changes and license amendment changes is not required.Reatory Guide 1.36 Rev. (0) -Adopted The conformance to this Regulatory Guide will be as addressed in Nýometa`l*
Tieriymetsuetion for each station's UFSAR.Auitenitkletairness Steel ReuA y Guide 1.37 Rtv (0) -Quality Conforms RG 1.37 Rev (0) incorporates ANSI N45.2.1-1973 for both Assurance Requirements for. Cleaning of construction and operation Fluid Systems and Associated Components of WatexCoold Nuclear Power Plants 17-6 Amendment 40 Table 17-1 Conformance of DEC's Program to Quality Assurance Standards, Requirements and Guides Standard, Requirement or Guide Conformance Remarks Status Regulatory Guide 1.38 Rev (2) -Quality Alternative RG 1.38 Rev (2) incorporates ANSI N45.2.2-1972.
The DEC Assurance Requirements for Packaging, QAP conforms to ANSI N45.2.2-1972 except container markings Shipping, Receiving, Storage and Handling shall be marked on at least one side (A.3.9(1))
and shall be of Items for Water-Cooled Nuclear Power applied with waterproof ink or paint in characters of a legible size, Plants and caps and plugs for pipe and fittings are required unless specified by Engineering, and off-site inspection, examination, and testing is monitored by personnel qualified to ANSI N45.2.12 in lieu of ANSI N45.2.6.Regulatory Guide 1.39 Rev (2) -Conforms RG 1.39 Rev (2) incorporated ANSI N45.2.3-1973 for both Housekeeping Requirements for Water- construction and operation.
Personnel accountability for Cooled Nuclear Power Plants personnel entering housekeeping zones F, I, and III without materials shall be maintained by housekeeping logs or alternate methods such as radiation work permits, confined space permits, work requests or other accepted methods capable of assuring personnel accountability.
Regulatory Guide 1.54 Rev (0) -Quality Alternative Catawba has adopted the Regulatory Guide. McGuire and Assurance Requirmnts for Protective Oconee adopt portions of the Regulatory Guide and address CoaPAPRiad to Water.Cooled Nuclear alternatives which meet the intent of this Guide, in each Power Plants respective station'sUFSAR.
Regulatory Guide 1.58 Rev (1) -Alternative RG 1.58 Rev (1) incorporates ANSI N45.2.6-1978 for both Qualification of Nuclear Power Plant construction and operation.
DEC's nondestructive examination Inspection, Examination and Testing (NDE) personnel will meet the qualification requirements of Personnel SNT-TC-1A and ANSI/SNT-CP-189 as governed by the applicable ASME Section XI requirement or other code requirement.
Operationaltfunctional testing personnel will meet: ..-therequirements-of ANSI N18.1-1971 rather than ANSI N45.2.6.Also, Leve I inspectors receive a minimum of 4 months experience as Level I before being certified as Level II, in lieu of one year experience recommended by ANSI N45.2.6. Inspectors
,,. , .assigned tasks for which they have been qualified.
,. Ad :RGI,044WV'(2) dOrporates ANSI N452.11-1974.
The use of Amendment 40 17-7 Tafh 1 am ftnPW V6gra "40t*Assurance skndavdt; Requimets.
and Gtides Standard, Requiremen or Guide Conformance R- .. ""s Status Assurance Requirements for Design of Clarification the*ork esimumedmts supervisor for design verification shall Nuclear Power Plants 0* restried to special stuations where the immediate supervisor is theonly-ind"viduat capable of performing the verification.
Advance jusfication for such use shall be documented and s.,ied by thesupervisors management.
And the frequency and.. .. .~.* ,: effectiveness of the supervisor's use as design verifier are , -, .,-indepe tly verified to guard against abuse. The supervisor will not be the design verifier on work for which he is the actual performer
/ originator.
RlgplrXGakdpt Conforms RG 1.74 Rev (0) Incorporates ANSI N45.2.10-1973.
Some Asauawc Turns -md Qefintionas definitions used by DEC are worded differently than those in this standard; however, the general meanings are the same.Regulatory Guide 1.88 Rev (2) -Collection, Alternative RG 1.88 Rev (2) Incorporates ANSI N45.2.9-1974.
The DEC Storage, and Maintenance of Nuclear QAP conforms to RG 1,88 except the records storage facilities Power Plant Quality Assurance Records have a minimum 3-hour rating. A qualified Fire Protection Engineer will evaluate record storage areas (including satellite files) to assure records are. adequately protected from damage.The fire protection engineer shall be a graduate of an engineering curriculum of accepted standing and shall have completed not less than 6 years of engineering attainment indicative of growth in engineering competency and achievement, 3 years of which shall have been in responsible charge of fire protection engineering work. The DEC program for storage of records on optical disks meets the quality controls contained in NRC Generic Letter 88-18.DEC fully meets NIRMA Technical Guide (TG) 11-1998, Authentication of Records and Media, NIRMA TG 15-1998,."Management of Electronic Records," and NIRMA TG 1&-1998,"Software Configuration Management and Quality Assurance" for...**managing quality assurance records in electronic media:: ... .. ......NIRMA TG 21-1998, "Electronic Records Protection and 17-8 Amendment 40 Table 17-1 Conformance of DEC's Program to Quality Assurance Standards, Requirements and Guides Standard, Requirement or Guide Conformance Remarks Status Restoration" -The data backup provisions in sections 5.4.2 and 5.4.4 are not being fully met. Until the backup requirements are met, dual storage or microfilm will be used for all QA Records.Regulatory Guide 1.94 Rev (1) -Quality for Alternative RG 1.94 Rev (1) Incorporates ANSI program for McGuire and Installation, Inspection, and Testing of Catawba conforms to ANSI N45.2.5-1974 except the length of Structural Concrete and Structural Steel bolts shall be flush with the outside face of the nut.During the Construction Phase of Nuclear Paragraph 5.5 requires inspection of structural steel welding to be Power Plants performed in accordance with the provisions of Section 6 of the AWS D1. 1. Visual Weld Acceptance Criteria (VWAC) for Structural Welding at Nuclear Power Plants, NCIG-01, Revision 2, prepared by the Nuclear Construction Issues Group (NCIG) and accepted by the NRC in their letter to the NCIG dated June 26, 1985 may be used as an alternative to AWSD1.1 for non ASME Code structural weld inspections. (July 31, 2000 J M Farley SER)Regulatory Guide 1.116 Rev (0-R) -Quality Conforms RG 1.116 Rev (0-R) Incorporates ANSI N45.2.8-1975 Assurance Requirements for Installation, Inspections, and Testing of Mechanical Equipment and Systems Regulatory Guide 1.123 Rev (1) -Quality Alternative RG 1.123 Rev (1) Incorporates ANSI N45.2.13-1976.
With Assurance Requirements for control of respect to ANSI N45.2.13, Section 3.2, "Content of the Procurement of Items and Services for Procurement Documents," Subsection 3.2.3, "QAP Requirement," Nuclear Plants DEC takes the following exception:
When purchasing commercial-grade calibration services from calibration laboratories accredited by a nationally recognized accrediting body, the procurement documents are not required to impose a QAP consistent with ANSI N45.2-1977.
Nationally-recognized aorediting bodies include the National Voluntary Laboratory Institute of Standards and Technology (NIST) and other-9-6001ng bodies recognized by NVLAP via a Mutual-. ,- .: m._ .. f gpitioiiAw"e' F 6#ARA). In such cases, accreditation Amendment 40 17-9 Table 17-4 Conformance of DEC's Program to Quality Assuawl aqukrmsnts and Guides Standard, Requirment or Gulde Conformance
.Staus mayWbe:a:epted in lieu of the purchaser imposing a QA Program oonsistent withANSI N4512-4977, rovided all the following are 1. The accreditation is to ANSI/ISO/IEC 17025. 2- The accrediting body is either NVLAP or an accrediting body reoognized by NVLAP through MRA. (NVLAP or American Association for Laboratory Accreditation (A2LA))3. The published scope of accreditation for the calibration laboratory covers the needed measurement parameters, ranges, and uncertainties.
Note: Well defined and documented measurement assurance techniques or uncertainty analysis may be used to verify the adequacy of the measurement process. If such techniques are not used, the collective uncertainty of the measurement standards shall not exceed 25% of the acceptable tolerance for each characteristic being calibrated. (This is typically referred to as the four-to-one ratio.)4. The purchase documents impose additional technical and administrative requirements, as necessary, to satisfy DEC QAP and technical requirements.
As a minimum, the procurement documents shall require that the calibration certificate/report include identification of the laboratory
"'.j ; : :ý .. .equipment/standards used.5. The purchase documents require reporting as-found calibration data when calibrated items are found to be out-oftoleramce.
17-10 Amendment 40 Table 17-1 Conformance of DEC's Program to Quality Assurance Standards, Requirements and Guides Standard, Requirement or Guide Conformance Remarks Status Regulatory Guide 1.143 Rev (1) -Design Conforms Guidance For Radioactive Waste Management Systems, Structures, and Components Instaled in Light-Water-Cooled Nuclear Power Plants Regulatory Guide 1.144 Rev (1) -Auditing Alternative RG 1.144 Rev (1) incorporates ANSI N45.2-12, (1977). The DEC of Quality Assurance Programs for Nuclear Power Plants QAP conforms to ANSI N45.2.12-1977 for internal/external audits except Section 4.4.6. In lieu of making recommendations for correcting program deficiencies we will identify the deficiencies to the audited organization.
For external audits, the results of the audit will be provided to the audited organization in lieu of the audit report. Also, the re-evaluation may be extended to 15 months and the triennial period as specified in the Reg. Guide may be extended by3 months as described in Section 17.3.2.4,"Procurement Control." Additionally, the DEC QAP meets regulatory position C.3.b of this regulatory guide, as clarified by NRC Information Notice 86-21, Supplement
- 2. Internal Technical Audits shall require a response describing corrective action and implementation schedule as requested by the audit report but not to exceed sixty days of receipt of the audit report.The requirements of Section C.3.b(2) are accepted with the following interpretation:
When purchasing commercial-grade calibrations services from calibration laboratories accredited by a nationally-recognized accrediting body, the accreditation process and accrediting body may be credited with carrying out a portion of the purchaser's duties of varifying acceptability and effective implementation of the calibration service supplier's QA program.hatiopolly-recognized accrediting bodies include National Voluntary LaboratoM-Accreditation Program (NVLAP)-4 -.-'?ý K7 ! -t4t T ", I C ý 11-1 0 -.4 1M ..7-' VýAmendment 40 17-11 Table 17-1 Coaformance of DEC. Program to Quality Assurance Standards, Requirements and Guides Standard, Requirement or Guide Conformance P0 ....Status 0mUsteredl by the National Institute of Standards and Tct.0ology (NIST)and .otheraccrediting bodies recognized by N ,VL aMutual Recognition Agreement (MRA).lnlieu of peromning an audit, accepting an audit by another licensee, or performing a cornmercial-grade supplier survey, a docuwented review of the supplier's accreditation shall be performed by the purchaser.
This review shall include, at a minimum, verification of the following:
- 1. The accreditation is to ANSI/SOAIEC 17025.2. The accrediting body is either NVLAP or an accrediting body recognized by NVLAP through MRA. (NVLAP or American Association for Laboratory Accreditation (A2LA))3. The published scope of accreditation for the calibration laboratory covers the needed measurement parameters, ranges, and uncertainties.
Note: Well defined- and documented measurement assurance techniques or uncertainty analysis may be used to verify the adequacy of the measurement process. If such techniques are not used, the collective uncertainty of the measurement standards shall not exceed 25% of the acceptable tolerance for each characteristic being calibrated. (This is typically referred to as the four-to-one ratio.)ReWasto'y GrM 1.146 Rev (0)- Alternative The DEC QAP conforms to ANSI/ASME N45.2.23 -1978 except Oudfl d of QA Program Audit Section 2.3.4. In lieu of prospective lead auditors participating in Persdnnel for Nudear PbWvr Plants a minimum of five QA audits within a period of three years prior to date of certification, prospective lead auditors shall demonstrate their ability to effectively lead an audit team and shall have.;i~K> -.participated in at least one nuclear QA audit within one year-- ........ .preceding the individual's effective date of qualification.
Upon 17-12 Amendment 40 Table 17-1 Conformance of DEC's Program to Quality Assurance Standards, Requirements and Guides Standard, Requirement or Guide Conformance Remarks Status successful demonstration of the ability to lead audts, and having met the other provisions of ANSI N45.2.23-1978, the individual may be certified as being qualified to lead audits. This process is described in approved procedures which require documentation of the evaluation and demonstration of results.Regulatory Guide 1.152 Rev (0) -Criteria Not applicable Regulatory Guide does not apply to plants prior to 11/85 For Programmatic Digital Computer System Software In safety-Related Systems of Nuclear Power Plants Regulatory Guide 4.15 Rev (1) -Quality Adopted Adopted at Oconee, McGuire, and Catawba via various site Assurance For Radiological Monitoring procedures that meet the intent of the Regulatory Guide.Program (Normal Operations)
-Effluent Streams and the Environment Regulatory Guide 7.10 Rev (1) -Alternative The DEC QAP conforms to the intent of this Regulatory Guide as Establishing QAPs For Packaging Used In addressed in each station's UFSAR.The Transport of Radioactive Material Criteria I of Appendix A to 1OCFR 50 Conforms 10CFR'50, Appendix B1- Quality Assurance Conforms Criteria for Nuclear Power Plants IOCFR 50.55a -Licensing of Production Conforms IOCFR 50.55a Specifies ASME Section XI Code dates. The DEC,i I ASME Boiler and QAP conforms to 1OCFR 50.55a with the specific editions and Pre6k Vess0 Code, S -ctlbnXI -Rules addenda of Section XI specified in the In-service Inspection (ISI)Inspection of Nuclear Reactor Plan for each station.Coolant Systems)10CFR 55- Operans ijoms Confonm 1OCFR 55, Appendix A -Requalification 9PO -s P!uction nt Amendment 40 17-13 VIbrUqu-kwS-4
'tf; Is- Program to Qualty Assurance Standards, Requirements and Guides Conformance Remarks 9-R1 l,.J -: .Conforms2 &'# ': " Conforms Fir-e protection controls are in accordance with the intent of"ti regulatory positions 2 & 4 of Branch Technical Position CMEB." "" 9.5-1 as'stated in the Safety Evaluation Reports for the respective
.--- nuclear stations.* r-17-14 Amendment 40 17.1 QA DURING DESIGN AND CONSTRUCTION Deleted 17.2 OPERATIONAL QA Deleted (NOTE: Amendment 15 of this Topical Report reformatted the description of the QA Program to follow Standard Revision Plan Section 17.3, replacing the content of 17.1 and 17.2.)'I.: .I ¸Amendment 40 171#146 ý 17.3 QUALITY ASSURANCE PROGRAM (QAP) DESCRIPTIONM, I. ..11 17.3.1 MANAGEMENT 17.3.1.1 Methodology
, The Chief Nuclear Officer is the corporate executive responsible for quality assurance (QA) and is the highest level of management responsible for establishing DEC's QA policies, goals, and objectives.
The QAP Policy Statement, shown in Figure 17-1, assigns this responsibility and'.requires development of and compliance with procedures in all QA Condition 1 matters. All'organizations performing quality affecting activities are bound by this Policy Statement.
The QAP has been developed in accordance with this Policy Statement.
The individuals who constitute Nuclear Generation have full personal and corporate responsibility to assure that nuclear power plants are designed, constructed, tested and operated in a manner to protect the public health and safety. The comprehensive program to assure this begins with initial design and continues throughout the life of the station. The DEC QAP must assure that the necessary quality requirements for QA Condition 1 structures, systems, components and materials are achieved.
All special equipment, environmental conditions, skills and processes that are determined to be QA Condition 1 will be provided within the scope of the QAP.QA Condition structures, systems, and components are specified by approved design documents and directives.
This program applies to the QA Condition 1 portions of the plant but may also be optionally applied, in whole or in part, to other selected items necessary for reliable operation.
Section 17,"Quality Assurance" identifies those items currently included under the DEC QAP.17.3.1.2 Organization 17.3.1.2.1 Corporate Organization The President and Chief Executive Officer has overall responsibility for Design, Construction, Operation, and Decommissioning of generation and transmission facilities.
Reporting to the President and Chief Executive Officer is the Group Executive responsible for nuclear operations, nuclear development and nuclear decommissioning, and project management.
Reporting to this Group Executive is the Chief Nuclear Officer (CNO) who has the overall authority and responsibility for the QAP and Nuclear Generation, which includes the operation of the nuclear plants. Also reporting to the President and Chief Executive Officer are Group Executives responsible for providing support to Nuclear Generation for the following:
electrical transmission; electrical distribution laboratory services switchyard maintenance and'technical support; support for the emergency response communications; Information Technology Services; and support of the Access Authorization, Fitness for Duty, and Fatigue Rule programs.
The interfaces with organizations providing those activities are described in Section 17.3.1.2.3.
As such, the attainment of quality rests with those assigned the responsibility of performing the activity.
The verification of quality is assigned to qualified Oersonnel Independent of the responsibility for performance or direct supervision of the activity.
The degree of independence varies commensurate with the activity's importance to safety.The policies described in this document are implemented through departmental program manuals and procedures, and are, therefore, transmitted to all levels of management.
Organization charts for the Nuclear General Office Organizations and the Nuclear Site Organizations are shown in Figures 17-2 and 17-3 respectively.
Amn"dmnt 40 17.3.1.2.2 Nuclear Generation Nuclear Generation has direct line responsibility for all Duke Energy nuclear station operations.
Nuclear Generation is responsible for achieving quality results during engineering, preoperational testing, operation, testing, maintenance and modification of the Corporation's nuclear stations and with complying with applicable codes, standards and NRC regulations.
The functions of Nuclear Generation are directed by the CNO.The CNO formulates, recommends', and carries out plans, policies, and programs related to the nuclear generation of electric power. The CNO is informed of significant problems or occurrences relating to safety and QA through established administrative procedures and participates directly in their resolution, where necessary.
Nuclear Generation is organized into eight divisions..
The activities of each division are directed by an executive who reports to the CNO. Three of those divisions are headed by the three executives of Nuclear Operations, which are discussed in the. Nuclear Site description following the description of the Nuclear General Office. The remaining five divisions, which comprise the Nuclear General Office (NGO), are: Nuclear Engineering, Nuclear Major ProjectsNuoldar' Oversight, Organizational Effectiveness, and Corporate Governance and Operations Support.a) Nuclear General Office Nuclear Engineering.
The executive for Nuclear Engineering reports to the CNO. Nuclear Engineering provides broad engineering leadership and technical support to the nuclear sites with ermphasls op generic issues and consistent practices, providing expertise in safety assessmen w.twith technical support in the areas of risk assessment, radiological engineering, and safety, analysis; fuel management with leadership and technical support in the areas of ful supply, spent fuel management, reactor core mechanical and thermal hy raubic,'mqalysi;
- , -#A*electrical and procurement engineering with technical support in the areas of procurement engineering, nuclear process systems, and electrical systems and gaind pram's and components support in the areas of steam generator inspections and m~int'enaqi-engineering programs, component engineering, material failure analysis and mati .W science, equipment reliability, and ASME Code inspections and testing.Nuclear Engineering provides record storage and document management sprvices, technology planning, project control and technical support for infotmatilon applications and systems such as equipment databases, applIc1o.h, ad plant process information systems.NUclear Malor Prolects The executive for Nuclear Major Projects reports to the CNO. Nude lr .em r6*1 responsible for contracts, engineering and manageniment fteet.d-d'riu1eA'b*
'major projects.Nuclear Oversight The executive for Nuclear Oversight (NOS) reports to the CNO. NOS provides oversight of the general office and nuclear sites with QA program audits, performance assessment, : procurement quality supplier verification, and quality control. In addition, NOS provides an.advisory function to senior management through the NSRB. NOS also provides oversight of Nuclear Development and Nuclear Decommlesioning thftugh QA pmguamnaudits.
The NOS executive has the authority and organizationaW freedom to' identify qMly prebisms inhbute, recommend or provide solutions to quality problems through dbsignatoinnelsiV#rfy.ie implementation of solutions to quality problems, and einSure cost and stedule don~t n Ainendmw*t40 M M1 7' ý influence decision making involving quality. This includes full access to Nuclear Development and Nuclear Decommissioning and all levels of management up to and including the Chief Executive Officer.The NOS executive is delegated prmary ownership of the department QA progran description and is responsible-for day-to-day administration of the program and reolution of QA issues.If significant quality problems are identified, NOS personnel have the authority totstop Work as discussed in Section 17.3.1.4 pending satisfactory resolution of the identified problem.Also reporting to the executive for Nuclear Oversight is Employee Concerns, whidh investigates concerns identified through the Employee Concerns Programs to deter-miihe their validity and initiate corrective actions as appropriate.
Employee Concerns also promotes the Safety Conscious Work Environment (SCWE) Program and is sensitive to SGWE c6cerrs during investigations performed.
The executive for nuclear training reports to the CNO. The responsibilities of this organization include training and leadership development.
Cornporate Governance and Operations Support Tbe e*eryqe for Corporate Governance and Operations Support reports to the CNO.brprt3overnance and Operations Support provides assistance to help improve overall fleao ance. This centralized organization includes Protective Services (Security and AGCcSerkcAs);
Noear Support Services; Organizational Effectiveness; Regulatory Maj..r; Emergency, Prepsdnss Performance Improvement; and Operations Support.b) NuW&Ir lbtrOvgafafon, TYT!ie e1x1cuties of Nuclear Operations, each reporting directly to the CNO and Io(;s 'qe 1Qt;bne resisible for Oconee and Robinson nuclear stations; one reso ' fpr Ct ana rln McGuire nuclear stations; and one responsible for Brunswick an 6he rnlHarnis pi, rW, 6statoinis.', Reporting to each executive are the Site executives for the respective nuctear station.Rep ,y 0LP ..tiv* for eapch nuclear station is a Nuclear Plant Manager who is mwrw,. fb'qtyfor-tlhe qaife operation of the facilit including operations, maintenan"ee wod manag- .ant, ridiation protection, and chemistry.
The qualification' requirements for the Nuclear Plant Manager are in accordance with the provisions of ANSIl N18.1 as presented in each station's UFSAR. Also reporting to theSft x!c,,tlve~ilanLr,: WbO is re ponsible for regulatory afairs, emergency.rui. perfrmanc, enbvr0pmental services, andWaind s yasi te6 ngineeaing and a Site Tiamining managet,.
iach SXe executive also has a Security manager and a Major Projects manager matrixed to provide'services to the site. -" IMW& ilmdiic" h emiirwpu rs": &w~ry fluoW*~ vtaflo to ftheo~~oicecp in ry I~-a TfWt*WW**,Qs WuI Aswrwo. P*'wn Is describo of' referenc~ed (owan thws Topical p~vod i ~fito~i Capt 17,9f thw(P,)FSAR fpr each Nuclear Slatiqn., Auuna~en40 17.3.1.2.3 Department Interfaces Departmental interfaces are identified in QAP manuals. Quality related activities performed by departments other than Nuclear Generation are identified by and conducted in accordance with approved departmental interface agreements.
The following are generic descriptions of those other corporate departments and the services they provide. These generic organizations are referred to, as appropriate, within this document; however, approved departmental interface agreements establish and define the applicability of the QAP to the services they provide: CoGorate Communications Corporate Communications provides support for the nuclear site emergency response organization.
Environmental Health and Safety Environmental, Health and Safety provides environmental and laboratory support services.Nuclear Finance Nuclear Finance provides support for the nuclear sites in the areas of financial planning.Human Resources Human Resources provides support for the nuclear sites Access Authorization, Fitness for Duty (FFD), and Fatigue Rule programs.Information Technoloav Information Technology provides a variety of services and technical support'to Nuclear Generation for information technology applications and systems such as eqwipment databases, applications, and infrastructure.
Customer Operations Customer Operations provides electrical transmissions' distribution and sichybd.engineering, as well as providing electrical maintenance and testing uppirt, Nuclear Supply Chain Nuclear Supply Chain provides procurement services, storage, inventouy Om ;-and receipt inspection/testing.
'17.3.1.3 Responsibility
'A ," The individuals who constitute Nuclear Generation have full persond, and caqmrsaft-..
responsibility to assure nuclear -power plants are designed,'.
ooxmtRgted, mautaiftdi telmd WW operated in a manner to protect the public health and safety; anmtDasswureltQwerasn
-4*the QAP.Corporate audits are initiated and directed by the 'CNO. This 400its b it$ 0 1effbry '....assess the adequacy of the QAP. This audit is discussed in greiateii'det in 17.3.3..4,-"Corporate Audit." .! , ) '.; " It- r Appropriate procedures are developed, approved by the responsible implementing manager, issued for ue, and used at the kcation where the.
- e -: appropriate:
Sufflcientpersonnel are availale and trained with nksWrusorf=i rio to performing activities that affect quality.Amnendment 40 T4 lT. I 17.3.1.4 Authority Anyone involved in quality activities in the Duke Energy organization has the authority and responsibility to stop work if they discover deficiencies in quality. Personnel perforymwg QA and quality control functions have the authority and responsibility to stop unsatisfactory work nd.to assure the item/activity is controlled to prevent further processing, delivery, installation, orse until authorized by appropriate management.
If a member of the group performing the work disagrees, they are instructed to take the matter to their management.
The disagreement may either be resolved at this level or at any level up to and including the Chairnman, Pe and Chief Executive Officer.17.3.1.5 Personnel Training and Qualification A training program is established for each nuclear station and support organization to develop and maintain an organization qualified to be responsible for operation, engineering, testing, inspection, maintenance, engineering changes and other technical aspects of the nuclear station Involved.
The program is formulated to provide the required training based on Individual employee experience and intended position.
The program is in compliance with NRC licensing requirements, where applicable.
The training program is such that trained and qualified operating, maintenance, work control, engineering, inspection, testing, technical support and supervisory personnel are available in. necessary numbers at the times required.
In all cases, the objectives of the training program shall be to assure safe and reliable operation of the station.The tra i g9,program is kept current to reflect station engineering changes and changes in pr Ms.' A 6Itlniilng effort is used after a station goes into commercial operation for training
- e personnel and for periodic retraining, reexamining, and/or recertifying as required to assure that personnel remain proficient.
Personnel receive formal orientation training in basic QA policies and practices.
PersonA .eov additional.formal training, as appropriate, which addresses specific topics such as NR QA procedures, auditing and applicable codes and standards.
Special training of personnel in QA related matters, particularly new or revised requirements, is conducted as necessary.
Training and qualification records are maintained for each , We.0*oemurnation of formal training includes the objectives, content of the program, attendees, and date of attendance.
17.3.1.6 Corective Action DEC has action process whereby all;personnel are to assure cowditions aa .quftvdl mpronwptly V idetWied, oa.-olled, and corrected.:
This process is,!si,6W *tkmW onatt raluem end, itomsc ther, Ow.estabish, bime orfault., "thl, -process also provides for trending of problems to detect adverse trends in quality performaoce, inddinrprIate J!veIpf ma.nag#mont This process is discussed in 17.3.1.7 Regulatory Commitments
..*; *-. * .-.* .' " ., ..... .. ...The DWA.A14antt VA-b. regubionei codes, arA as dentified -i Tabie. 1 74ji GoWmtmar= .EdWQAP to Quality Aaturarnce Stenrd% R.quR nlmelnd*Guides.Aendient 40
$* DUKE S ENERGY.QUALITY ASSURANCE PROGRAM POLICY STATEMENT Duke Energy Corporation (DEC) designs, procures, constructs and operates its nuclear plants in a manner that ensures the health and safety of the public and workers. These activities are performed in compliance with the requirements of the Code of Federal Regulations (CFR), the applicable Nuclear Regulatory Commission (NRC) Facility Operating Licenses, and applicable laws and regulations of the state and local, governments.
The applicable Quality Assurance Program (QAP) is the Quality Assurance Program Description (QAPD) contained or referenced in each nuclear plant's (Updated)
Final Safety Analysis Report and the associated implementing documents.
Together they provide for control of DEC activities that affect the quality of safety-related nuclear plant structures, systems, and components (SSCs) and include all planned and systematic activities necessary to provide adequate confidence that such SSCs will perform satisfactorily in service. The QA Program may also be applied to certain equipment and activities that are not safety-related, but support safe plant operations, or Where other NRC guidance establishes program requirements.
The QAPD is the top-level policy document that establishes DEC's ovpraU philosophy regarding achievement and assurance of quality. Implementing documents assign detailed responsibilities and requirements and define the organizational interfaces involved in conducting activities within the scope of the QAP. Compliance with the QA ig mandatory for individuals involved directly or indirectly with its implementation.
DEC personnel have authority commensurate with their responsibility, including the authority to stop work that does not conform to established requirements.
This stop work authority may be exercised in accordance with established nuclear system procedures.
Date J.Lynn, GooýPresklent and CEO Duke Energy Quality Assurance Program Policy Statement updated with Amendment 40 Figure 17-1. Duke Energy Corporation Quality Assurance9 ,tement Amvndment 40 I)~174,t, ,
Senior Executive Nuclear*.Management Development and '1 "Offier... .. .Decommissioning
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,-Technology Nuclear Corporate Training Governance
&10ierati~ns
[Nuclear Supply Suppert .....Chain Support Figure 17-2. Corporate pnd Offslto Organizaton,rl( '- -! '"; L'L *':. ' "' ' .! 4 r i ',rt ;: 1142 f I mndment,40 Work Managemen Radiation Protection Chemistry Regulatory Environmental Healthh&Safety Emergency Planning Performlace.
Performance Security ,.'.: :" ." j ....:. Nuclear Site Organizatioh updated with Amendment 406 Figure 17-3. Nuclear Site Organization I Amen.,dment 40 : .1).. 4. 3 .. , I ...; ., ...: ;: * , , ,: -; : I, ,M : 3 Amendment 40 -
17.3.2 PERFORMANCENVERIFICATION 17.3.2.1 Methodology The DEC QAP is described in various Corporation manuals. Procedures and work instructions necessary to implement the requirements of the QAP are developed and approved by the organization responsible for the activity.
These procedures and instructions may be contained in manuals, station procedures and directives, administrative instructions and/or other documents.
These documents identify the criteria to determine acceptable quality for the activity being performed.
On-site implementation of procedures and work instructions is the responsibility of the Site Vice President.
Verification of quality against these documents is performed by means of inspections, tests, audits, and reviews. Procedures for such inspections, audits and reviews are developed and approved by the responsible implementing manager, The program receives on-going review and is revised as necessary to assure its continued effectiveness.
17.3.2.2 Design Control In order to provide for-the continued safe and reliable operation of a nuclear station's QA Condition I structuros, systems and components, design control measures commensurate with those applied to the original design are implemented during the operational phase to assure that the quality of such sfudtures, systems and components is not compromised by engineering changes.DEC has assig ro the iesponsibility for design activities during the operational phase of nuclear stations to Nuclear Generation.
The QAP and instructions, for implementation and assurance of design control during the aperational phases for QA Condition I items. These procedures and instructions assI*tNWedeaign is performed in accordance with approved criteria, and that deviations and nonrormoances are controlled.
Each QA Condition 1 se ie -nt s , ionh specification, or drawing, is prepared by a jnoWge!en4Uai ividual 'ho specifies and includes the appropriate codes, standards, SAc wns, 4nd otheridesign input within the design documents.
The preparer note4 any d vatý s change* from such standards within the design documentation package. Eac -S is then feckWeVrb'another individual qualified In the same discipline and is reviewed for concept and conformity with applicable codes, standards, and other design inputs (as specified within the design documentation package).
The document is approved by the individual having overall responsibility for the design function.
A review of each specification is made to assure incorporati9n,of nec.essary QA iformto .The entire review process is documented.
Prior to the release of any QA Condition I design document, it is tewewed to assure coordination of disciplines.
If the document clearly involves no coordination with the other disciplines, this review may be waived by the sponsor, with documented concurrence by the other disciplines.
In order to assure proper interface control, the responsibilities of the various individuals/organizations involved in engineering changes are formally identified.
The assignment of responsibility for the evaluation and design of a particular engineering change to a specific individuallorganization is documented.
Also, the written instructions addressing the 1T44 I 44AmendsueW-40ý.
control of engineering changes address the communication of information between involved individuals/organizations and, where appropriate, require documentation of such communications.
For each proposed engineering change, the individual/organization assigned responsibility for evaluation and design of the engineering change considers the following in the design of the engineering change: a) Necessary design analyses, e.g., physics, stress, thermal, hydraulic, accident, etc.b) Compatibility of materials.
c) Accessibility for operation, testing, maintenance, inservice inspection, etc, d) 'Necessary installation and periodic inspections and tests, andacceptance criteria therefore.
e) The suitability of application of materials, parts, components, and processes that are essential to the function of the structure(s), system(s) and/or component(s) to be modified.Final approval prior to implementation of each station engineering change shall be by the.Nuclear Station Manager or the Manager of Engineering; or for the Nuclear Station Manager by the Operations Superintendent, the Maintenance Superintendent, the Work Control .Superintendent, or the On-Duty Emergency Coordinator as previously designatae by the Nuclear Station Manager. Engineering changes are then executed in accordance with approved checklists, instructions, procedures, drawings, etc., appropriate tO the, hature 6f the work to be performed.
These checklists, instructions, procedures, drawings, etc.ir'ckude criteria for determining the acceptability of the engineering change.Errors and deficiencies noted in the design of an engineering change are opirrecded by oens of an EC Revision.
The control measures applied to each such EC Revisi'n are tQ he control measures applied to the engineering change originally.
Each EC Revision and the review and approval thereof, is documented.
Prior to an engineering change being declared operable and returned to rvico, $A pr...es.governing the operation of the engineering change are reviewed and revised as ne"ssawy, If the engineering change'significantly alters the function, operating procedure, or operating equipment, then. additional training is administered as necesy.Adequate identification and retrievable documentation of station edihl#r isi retained for the life of the station.Computer programs are controlled in accordance with appropdrate de dures, whereby programs are certified to demonstrate their applicabiity and .vucfij ,.17.3.2.3 Design Verification During the check and review of design docuwtqit, partiwPr *vn powipl, 4 .9e n ssuring conformance With applicable codes, quality standards, SAR design commitments, and other design input. the individuals' assigned to ,erform the c08'afrevie 6a QA' l fittbn I document have full authorityto withhold apWovO-1f-the do~mwnt uutijoery quw*ltn concerning the work has been resolved.
If required, the matter can be carried u to the Chief Nuclear Officer by individuals in'Nuclear Genera Office d,- t6OIl* fte'V16 At$s ntby individuals in Site tngineerlng for resolution.
The checker W ieIrg or by alternate computatiOns.
Analytical models, theorist, exaitimp, tabWei, obdes, m1r programs, etc., used as bases for design must be referenced in the design document and their Ameindment 407 17-25 ?-ý, I application verified during check and review. Model tests, when required, to prove the adequacy of concept or design are reviewed and approved by the responsible erglineer.
The, tests used for design verification must meet all the requirements of the designing activity.Computer programs are controlled in accordance with the applicable QA Manual whereby programs are certified to demonstrate their applicability and validity.Design verification may consist of reviews, alternate calculations, and/or qualification testing., Design reviews are intended to verify the correctness of design inputs, logic, calculations, and analyses.
Calculations by alternate methods provide assurance that, for instance, computer codes are performing as expected, and that no systematic enror In Cal~ulation prooedures exists.Qualification tqstirpg, when suitable, is guided by DEC's adoption .Qf various regulatory guides which deal with .qucalification testing, Qualification testing will simulate the most adverse design conditions that are expected tO be encountered.
Design verificatioh is performed by qualified individuals in accordance with approved procedures which identify the respohsi5ilities, features api pr.nent considerations to be verified such as verification method, design parameters,,teria, and documentation requiremernts.
Design verification is required to be completed before relying on the item to perform its function and before its installation becomes irreversible.
The use of the originator's immediate supervisor for verification is: 1) restricted and justifiedto sp"I 0 lsituations where the immediate supervisor is the only individual capable of peiohfM§ Wie- V oiflctbon
- 2) the need is individually documented and approved in advance by the supervisor'edtfianageoment and 3) the frequency and effectiveness of the supervisor's use as design o z1feendently verified to guard against abuse.Theý va rgmqation assigned responsibility for evaluation and design of a engineering awie Pe$fpps an evalklation of the proposed engineering change. This evaluation provides the bases for whether or not the engineering change requires a license amendment.
This evaluation is reviewed by an individual/group other than the individual/group performing the 6valuoitR'i*hdi'may be flom the same Organization as the individual/group which performed the Oaf jlb~i -n. TlsleluatiorW and the review thereof are documented.
Following completion of design and evaluation of an engineering change, the responsible individual/organization summarizes the engineering change design and identifies the design.W1AW I Md l If m in redfbr engineering change implementation.
This addresses a) A d6scription of the "g ing hange.bý %ppcw d in" Mtio yalation and. design of the engineering change, and necessary for the implementation of the engineering change.d) Operatiofb,,, t:;eit ftearenaead inspectieot requireffietiAts.
.e) Materials, parts and components required in order to n change.,i -c fi.r, The're'~~
V. I ;*T~ ~-~..Owo .du g app.lcale i prlNqc 0ures Ih AqW~i~ hayq ~ej.ne6 inspection, a .... :reqr ie nd 0ner, rfu nenng cae..Eneerzng cl~nges which.!, -, * ., ,, : ; , '- ', .:. ..: .-i .-.-17-26 Amendvtent 40 ' .
are determined to require a license amendment are reviewed by the PORC and must be authorized by the NRC prior to implementation.
17.3.2.4 Procurement Control The DEC QAP requires the control of QA Condition 1 items or services purchased from a supplier, subsupplier, or consultant through appropriate processes and specific procurement documents.
Pertinent provisions of IOCFR50, Appendix B are applied to these organizations.
If a supplier is providing commercial-grade calibration services and is accredited by a nationally-recognized accrediting body as described in Table 17-1 for Regulatory Guides 1.123 and 1.144, a documented review of the supplier's accreditation by the purchaser may be used in lieu of inspections or tests following delivery or in-process surveillances during performance of the service. This review shall include, at a minimum, all of the following:
- 1. The accreditation is to ANSI/ISO/IEC 17025.2. The accrediting body is eithe" National Voluntary Laboratory Accreditation Program (NVLAP)or an accrediting body recognized by NVLAP through an MRA. (NVLAP or American Association for Laboratory Accreditation (A2LA))3. The published scope of accreditation for the calibration laboratory covers the needed measurement parameters, ranges, and uncertainties.
Note: Well defined and documented measurement assurance techniques or uncerta!nrty analysis may be used to verify the adequacy of the measurement process. If such techniques are not used, the collective uncertainty of the measurement Standards safl riot exceed 25% of the acceptable tolerance for each characteristic being calibrated. (This is typically referred to as the four-to-one ratio.)The QAP supplements appropriately the ASME Code QA requirements with thergulatory guides listed in Table 17-1, with the clarifications or alternatives stated ther*l,. .Procurement of QA items is to the quality program requirements in effect at thermeo -purchase.
....Nuclear Generation is responsible for the technical qualfficati.on of suppliers indmdriroiif the initial procurement of all QA Condition 1 items and services.
Procurement requirements/specifications are prepared, checked, and approved tby appr6 0 0ewonhel arfd forwarded to the Nuclear Supply Chain division, who prepares an- Irquity hirk 1btWar'"'it to approved suppliers.
NOS-Procurement Quality is responsible for quall'If O 0i1pUl6e QA programs.QA Condition I material, equipment and services procured as bosic conownentinmay ohty W1 procured from qualified 6ulptiers, tupplier qualciotionis tia PIS-, Procurement auality evaluation of the suoppier QA ptograi. ** soyý t"'.performed by 'NOS-Pocurbm~entQuality when req'uired".'
1ý'e adAbd opr ef v Fh',s -carded out in accordance with a comprehensive audit'cheddlttto detillhf.W h th.suppllir QA program and man'ual()
to met applicablfM.
ceHl'df ". Apdi. i.ASME Code when iequirWd, arid any other dedeý and dds det,-& b t *lefe for the prospective scope of supp*y,: The auditorvy milnldeoe S ie aOwIw.t QA&program manuals. The audit team preparese formalaudit report_~hich satole wwlewtohrot the'supplier is qualfd: to supply the spcif' kerimeor sonimi.l.: -The mliitmrp.rt*m"Wed1 and approved or disapproved by the NOS-Priocurement Quality manager. Ap~ eiplfliers;.;
of basic components wilt then be included on the QIifWmd Suploier List,.- To.mic.al qualifications are determined by engineering peorinel.
Commer(clsqualiicatiois deV*m d Amendment40 17-27 -," .";
by the Nuclear Supply Chain division following evaluation of bids from qualified suppliers, Sid evaluation includes evaluation of the technical, quality and commercial qualfications of the prospective suppliers.
When QA Condition 1 basic components and services are procured from a lglupplier whose quality performance has not been verified by audit, additional assurance of product quality sho be obtained by supplier surveillance, inspection or test.The Manager, NOS-Procurement Quality may place a supplier on the Qualified:
Suppliers List following review, approval and acceptance of an audit performed by another licensed nuclear.uliity .or joint utility audit. team, Review of such third party audits shall ensure that items.to be...: procured are within the audit scope and any unique plant quality and technical requirements are adequately addressed by such audits.NOS-Procurement Quality will perform a documented on-going evaluation of each supplier in order to maintain the supplier on the Qualified Suppliers List. Where applicable, this evaluation will take Anto account. (I review of supplier-furnished documents such as certificates of confdrranoe, nonconf6trnance notices, and corrective actions, (2) results of previous source.verifications, audits, anid' receiving-inspections, (3) -operating experience of identical or similar products furnished by the same supplier, and (4) results of audits from other sources (e.g., customer,,ASME, or NRC audits). The results of the.evaluations will be reviewed and appropriate corrective action will be taken. Adverse findings resulting from these evaluations, will ro:., _Oally reviewed in order to determine if, as a whole, they result in a significant conditon ia' .rs.Q to qua'ity and to provide input to support supplier audit activities Conducted by theýi."n~oe~r y auditing entity. Additionally, suppliers will be re-evaluated bymeans of an au, t00'10 'nniaily, "if initial approval was by audit or survey. The triennial audit requirement rhiay be extended by-3 months, from 36 to 39 months, with written approval of the Manager, NOS-Procurement Quality. Extensions would be on an infrequent basis for reasons such as -0.1m odatlgr manuf:iduring schedules, synchronizing with other utility audits, or allowing time for lmpWeMrntatl.n of supplier QA program changes.Materials, a Alntd nsshall be procured to specified technical and quality requirements at least equivalent to those applicable to the original equipment or those specified by aprppge rm ýan p o V revision, As required by the applicable purchase do66ment%, fs 4ýg& tat.on which identifies the material and equipmentt~p prmremnt requirements met by the items. Also, as required by the wo 01 F 4).luppjierswill provide, documentation which identifies any.[~i., .M ha ot been comp.ied with, together with a-description of., any devlafiOrs and repair recds.p/oneI ,,ryic§ mae, not supp wit4 s a ..mponeif; and me*.thp defnitlbn W crIto -PWm rd" re~in9 r~nleuir dwdu .' n, .#Nucr tq."nn ý6# itq 1,he dedctoofnr nrqt to the J: the lnhee ftmnc~bt i4tem t hak*ttdw uded- for; e ptarlc.and
, dedication of dwIagrdmsaeeftdt l*l eaoaea.Wn that the dwm~wImemig euttue pcfctoi n ilpvfm~encsv 17-28 AmendmenM40,.
i, ,:
safety functions in the intended applications.
Verification of critical characteristic acceptability will be by manufacturer/supplier survey, source verification, receipt tests or inspections, or post installation testing. Historical data, when documented, will represent industry wide experience.
If verification of a critical characteristic is to be by supplier survey, NOS-Procurement Quality is responsible for verifying the acceptability of the supplier control of the identified critical characteristic.
Procurement of materials, parts, components and services associated with QA Condition I structures, systems, and components is controlled during the operational life of the station so as to assure the suitability for their intended service and that the safety and reliability of the station, are not compromised.
Procurement information for materials, parts, components, and services associated with QA Condition 1 structures, systems and components is identifiably designated as such. The procurement requirements applicable to each item are determined by a cognizant individual.
This determination is reviewed by another cognizant individual who may be from the same organization as the individual/group making the determination.
Procurement informationmust include or reference other documents such that sufficient information is fully Identified to specify the items being procured.
Subsequent to preparation, procurement information is approved by the Procurement Engineering or Nuclear Supply Chain manager or designee who is qualified by experience and training for the function.Procurement information for QA Condition I materials, parts and components Is reviewed to assure that QA, technical and regulatory requirements including supplier .pcunentation
.requirements are adequately incorporated into the purchase document(s).
Sign4itcant chianges to the content of such purchasing information are reviewed and approved in a manner, consistent with the original.Where necessary, procurement documents require that QA Condition 1 materials, pqrt, ano! ,, components be acquired from suppliers determined to be acceptable by N0S9Pkur~
jt. I Quality -see Section 17.3.3.2.3.2, "NOS-Procurement Quality." Detfrmination of requires that a supplier provide DEC the right of access to the supplier's facilities and records for inspection and audit.Except for some commercial grade items each shipment of item4 procured fr m a supplier must be accompanied by a certificate of conformance (or equivalent) which ldentvZfi'the applicable procurement documents and item(s). The certificate and supplier dvoc nlia'ecifies that the item meets the procurement requirements and includes repair-* Wr sind a decription of any deviations.
This documentary evidence must be on site(anW locatlortbnder**QA Program) and all procurement, inspection, and testing requiremwift sh&M hk b v1 he item is placed. in service or used.Nuclear Generation personnel wilt review and approvethis dou en e m titem conformance with procurement requirements.
..17.3.2.6 Procurement Verification The approved procijremen documents ako~pg with at 6uality!p t ecn! 'ulremnts are prviel othe Supplier by'Nuclear _ n'o.n.t pinboed to the NOS-Procurement Quality sectiOn and the reCeiving localY: :i 9 omt ... to1' tth As required by procurement criteria, in order to assure that and ea,"pmegt are fabricated in accordance w~ith applicoblo requuirbmens, "U~lIlr reviw, aud4 l are performed by the NOS.Procurement Quality sectidn. Fie teviev, tudit And Ur Hllance Amendment 40 7-17-29 ý':,c -,
may include witnessing of tests, observation of fabrication checkpoints, and documentation, review. Evaluation of overall supplier performance is performed at intefvalsand to adepth consistent with the item's or service's importance to safety, complexity, and the quantity and frequency of procurement.
Procedures are established which implement the surveillance program for suppliers.
This assures that items and services procured for use in nuclear QA Condition I applications are in compliance with applicable procurement requirements/specifications.
These procedures provide for surveillance of those characteristics or processes to be W*9*e, irdSpected or verified.
Surveilance activities assure that the supplier compiles with all quality requirements outlined in the procurement document(s).
The surveillance report, becqofes'a part of the NOS-Procurement Quality section files. The surveillance representative has the authority and responsibility to stop work when the required quality standards are not met.Upon receipt, QA Condition I materials, parts and components are placed in a controlled, designated areaand are subjected to a receipt inspection.
This inspection is intended to d6te"mYt whether or not each item received conforms with applicable procurement reqUirements.
Such inspections and thesubsequent determination of conformance or nonmnoooranceare documented by means of reports, which are retained on file and as appropriate, by tags attached to the items.. Until a determination of conformance is made, a QA.Con;tglp ,i material, part or component cannot be placed in service.17.3.ý6, "]dentflcation'nd Control of Items Control of matdrlals, pait , and components at nuclear sites is the ultimate responsibility of the Chief Nuclear Officer with responsibilities delegated to Nuclear Supply Chain.Ide ¶ 06_i0iientO for materials, parts and components important to nuclear safety are s 0 Ot Mr1 di.ngs and purchase documents.
Specific identification requirements a) Materials, parts, components, assemblies, and subassemblies shall be identified either pr, The Rem or rcoros traceable to the item to show that only correct items are AY, a 6ps,,hm OI, hIuas pressmr, vessels are identifiable by nameplates as1**j;ldWAp c" md or DEC specifications.
Materials%
parts, and , Ltwawmismetrop ftom such identification to a:specific purchase order to.r ,d ,IWrhilS PonCO4ild to.QA records and documentation.
c) When required by procurement documents, materials are identified bý heat ~ 1W sn cs'~cambltoth.origial~nhlrietilet rem'*l. Uponvoceipt.
a unique tracking number ls assigned to pmovide tra9abii W-t.nsew .l peftsere, assembled, a lisi bf parts and corresponding numbers is included in the documentation.
,.by. ptq'kl~te or coes and d ndrd, itifition Qf material or-* ",1 .4 ..... -o unique tracking number.th" ' o ...e "t" o 0 W " " .' .'*WAd~ir V nA be,6 tak~e. to. precludek id~tifyihg materi ta~wflf~t~n~1Q~r
~aflt ofthe t bili' -dutlid 17-30 PA.C " t Amendment 40 .,:.
Control of material, parts and components is governed by approved procedures.
Specific control requirements include: a) Nonconforming or rejected materials, parts, or components are identified to assure that they will not be inadvertently used.b) The verification of correct identification of material, parts, and components is required prior to release for assembling, shipping and installation.
c) Upon receipt, procedures require that materials, parts or components undergo a receipt inspection to assure they are properly identified and that the supporting*
documentation is available as required by the procurement requirements/specifications.
Items having limited shelf or service life are identified and controlled..
d) Each organization which performs an operation that results in a change In the material, part or component is required to make corresponding revisions and/or additions to the documentation record as applicable.
Following QA receipt inspection, materials, parts and componentswhich are determined to be acceptable are assigned an identifying designation such as a unique tracking number in order to provide traceability of each item. This traceability is maintained for QA Condition I items. In the event that the identificationof an item becomes lost or illegible, the:item is considered nonconforming and not utilized until proper resolution of the nonconformance.
When a designated item is subdivided, each subdivision is identified in accordance with the above requirements.
Where physical identification of an item is impractical or insufficient.
physical separation, administrative controls or other appropriate means are utilized.17.3.2.7 Handling, Storage, and Shipping The QAP requires that QA Condition 1 materials, parts and comPonents be handled, stored, issued and shipped in such a manner that the serviceability and QA taceabtlty of-an Item is not impaired.
Handling, storage and shipping of an item is in accordance withOrry spectal requirements identified in documents pertaining to the item. Sucht recqwtmdnt5.
layiinclude special handling tools and equipment, special protective coverings antllrapsetffective environments.
Items are to be marked or labeled to preserve the Item'.s integr'it aJindicate the need for any special controls.
Procedures identify predetermined requirements ibr handling, preservation, storage, cleaning, packaging, issuing and shipping and adf UtMNed by suitably trained individuals.
Conforming QA Condition 1 materials, parts and componenes retaro.qrd
- i. p"'9lle4s segregated areas designated for the storage of such items. Inspections and examinations are performed on a periodic basis to assure that recommended Melf-W of-dyet ilb, and other consumable materits is not exteeded.'
HAzdeu§ itetMs aMe ~tvtii U environments with conti'ola-t prievent contaminat1on df'QA Cd n t s, or: components.
Nonconforming items are identified, segregated, or otherwise controlled (e.g. by a icndilional release) in such a matuer as to preiludetheir inadveitnt rg$Id'ua" conforming med'erials parts and`components.
..*. .. c..: 17.3.2.8 oitr The QAP addresses both prebpertionel and perlie tesOirM. Tgp"rtaogmm
, requires that such testing associated with QA Condition 1 structures, systems and components Amendment 40 .17-31 ",.. "
'demonstrate that they will perform satisfactorily in service. Testing activities are,acoomplished in accordance with approved, written procedures.
Testing schedules are provided and-ompintained in order to assure that all necessary testing is performed and properly evaluated on A timely basis.Test controls include requirements on the review and approval of tept procedpures, and on the review and approval of changes to such procedures, as discussed in Section 17.3:2.14,"Document Control." Also, specific criteria are established with regard to procedure'content.
Examples of items which must be considered in the preparation and review of procedures" include: * ,:a) References to material necessary in the preparation and performance of the procedure, including applicable design documents.
.Tb) ests which are required to be completed prior to, or concurrently with, the specifiedtp~skng,. c) Special test equipment required to perform the specified testing.4d Lmits and precautions associated'with the te6ting.e) Station, unit and/6r system status or en6h'ditions necessary to perform the specified f) Crnteria for evaluating the acceptability of the results of the specified testing,., ,,ompatible with ,any applicable design specifications.
Test *teaurds the following information or require this information be documented:
a) Requirements and acceptance limits contained in applicable design and vendor documents.
,). Insctr ls for performing the test.WT :,,,RTiesjoh as.calibrated instrumentation, adequate test equipment and*4vw t kimkxding their accuracy requirementsi, completeness of the item to b:-,b* WOO or e a controlled environmental conditions, and provisions for data l .,p5Ctibfl 164 points.~ ~ A(~Q #Ad~ pffloipriteri f) Methods of documenting or recording test data and results.1" 0 t -stfi erql Aits hee eei e Req* o" O -#*4fOW, v*rAqn of t mletio an or deter ling .accepts.flty, 4t.! k* resoi qe agnd aqcaed by-th, .g oranizatan anr~ tý#peq* b1prfhqt#p -m Ng tqW. 1nh hat te~ re;uR o not.meet test acceptance criteria, a review of the test, test procedure and/or test results , .conducted to determine the cause, required corrective action, and retest as necessary.
In addition ta'.t tntVnaw tormWTtior atip o, QXC Corg ,on.1 structures, systems and components, other post wC. 4 testing, or functional verifications are performed and documented as required to verify satisfactory performance of the affected items. Post malntenance/mqOP na.jctionalt verifications are not subject to the requirements of periodic testing descrbed above because they are *wot*l gpiclw*iet ipos #*tVt re snmp~e OW ptra*ghopiwara.
JrIcuded mi 17-32 t,"17-32i.1~Amendueen44-these tests are such items as diesel generators, reactor control rod systems, and leak testing of appropriate pressure isolation valves.17.3.2.9 Measuring and Test Equipment Control The organizations performing QA Condition 1 work activities have the responsibility to assure the required accuracy of tools, gauges, instruments, radiation measuring equipment, non-destructive testing equipment and other measuring and test devices affecting the proper functioning of QA Condition 1 structures, systems and components and that a program of control and calibration for such devices is provided.
This program includes the following:
a) Devices are assigned permanent, identifying designations.
b) Devices are calibrated at prescribed intervals, and/or prior to use, against certified equipment having known, valid relationships to nationally recognized standards.
The calibration interval for a device is based on the applicable manufacturer's recommendations.
If experience dictates that the manufacturers recommendations are not appropriate, the calibration interval is changed as necessary.
, c) Devices that have been acceptably calibrated are affixed, where practical, with 9 tag, or tags, showing the date of calibration, the'date the next calibration is due, an indication that the device is within calibration specifications and the identification of the individual who was responsible for performing the calibration.
When attaching tags is not practical, the device is traceable by unique identification to the applicable calibration records.d) Devices which fail to meet calibration specifications are affixed with a tao, or tags, showing the date of rejection, the reason for rejection and the of the individual rejecting the device. "Accepted" and "Rejected" calibratiOrnags e sufficiently different to preclude confusion between them.e) Items and processes determined to be acceptable based on measutrbitres made with devices subsequently found to be out of calibrati0tare re-evaldfaed.
f) Devices stored under conditions which are in accordanc with, ox orne 0nservative than, the applicable manufacturers recommendations.
g) Devices are issued under the control of responsible personhel -d asto pr'ctdo unauthorized use.h) Devices are shipped in a manner that is in accordance with,: or m corlgerVetv than, the applicable manufacturer's recommendatio~s.
i) Records are maintained on each device which identify such items as the device designation and the calibration frequenry and speclations.
Recarisart.-..
maintained to reflect current calibration otsla., j) As a rule, the calibration program achieves a minimum MatO6 bf 4-to-I btt*o #-standard accuracy to measurin.and tet,equipmerfaccumreyunleeW iabv4he state of the art; however, when an accuracy ratio of less than 4.4o,1 4s ubuiAe* an evaluation of the specific case is made pnd documented.
Installed instrumentation is subject to ft tequirements of the Techniost 8peoal an0itJnot subject to the tagging requirements
- disoussed in (¢) and (d) above. The NO$.6Awldit, sevin verifies implementatio of the calibration program.~.
periodcafudit., Amendment,40 17-33 '
The basis for this exception on the installed Technical Specification required equipment is the. -Preventive Maintenance Periodic Testing (PMPT) program. This is a computerized program that automatically schedules PMPT using model work orders. When devices have been acceptably calibrated, the clock starts for the next calibration due date. Ttft indicatia that the device is within calibration specifications and identification of the individual who was responsible for performing the calibration is documented within the calibration procedure for the'device. If the device fails to meet calibration specifications, it will be repatred).replaced and/or engineering Involvement will be requested to further evaluate.
The PMPT prografm along with the calibration procedures address all the requirements in Topical Report Sections 1723.2,9 c and d listed 'above. Therefore, there is no need to place tags on'the devices to Identify the calibration status Inspection, Test, and Operating Status In order to assurelhat equipment status is clearly evident, and to prevent inadvertent operation, the QAPF*requlre)QA Condition I structures, systems and components which are in an other than operable statts to be identified as such. This identification may be means of tags, labels, stqmpS.pr other suitable methods. Where appropriate, an independent verification of the correct irnplern~nt~rin.of sugh identification measures is performred.
When tags, labels or stamps are the dent~ftipn of equiIpment status, the issuance and remoVal thereof is doc~,~wiwt kirder lo sure proper control of such identification measures.
Also, procedures rqilre 9t t ab qp J0aif of, an item removed from operation for maintenance or testing be ver'rifle'
'ior to returning the item to normal service.insl ons d ,ptereqyir'd by the written approved procedures which address work activities are iI deferred.
When such a deferral does occur, a discrepancy is con Sedt i't-u i entation of the acceptable completion of the affected work activity is not pe l orrn until the discpancy is resolved..." t oiodp ri~rtswh.i..
affect station nuclear safety and are not addressed in0 R4eport or Technical Specifications shafl be prepared and approved in a nnir ertical'to that used for station procedures as described in Section lCdY*iroV, eproposed tests and experiments shall be reviewed by a knowledgeable individual/organizatimo,other than the individuavorganization which prepared the propQeq"W4"M
~RnSM&n Measures taken to identify equipment inspection and test status by Nuclear Generation pomppQ i Prop Gnation..17..2.11 Special ProcessControl The nslWsfeb e aOdperfomance of the station's program for the control of spai for askuringfttheassary quali" .:.The QAP contains or references procedures for te control of special prode~se' sikh as W 1tt6lng;en#okng.
Tft progrm. raqtkes thatWA 11is,ýtIUlV invc ordante wift, pleabl. codes anO. ,andard*, be.utilized when the perfo Of l prper~fUc of A .Condition I structures, systems, and components.
These procedures shall provide for 17-3!4 U-ýt.Amendment 4.I0::,i ,
documented evidence of acceptable accomplishment of special processes using qualified procedures, equipment, and personnel.
Personnel performing such activities must be qualified in accordance with applicable codes and standards.
Adequate documentation of personnel qualifications is required prior to performance of the applicable special process. NDE personnel are certified to required codes and standards.
17.3.2.12 Inspection In order to assure safe and reliable operation,'a program of inspections for QA Condition I structures, systems, and components is established at each nuclear station. Inspection procedures for those activities affecting QA Condition 1 structures, systems and components are established by Nuclear Generation personnel.
Independent inspections, examinations, measurements, observations, or tests of materials, products or activities are conducted, where necessary, to assure quality. If inspection of processed material or products is impossible or disadvantageous, indirect control by monitoring processing methods, equipment, and personnel is provided.
Both inspection and process monitoring are provided when control is inadequate without both.Inspection procedures, instructions, and checklists contain the following information pr requre@this. information on inspection reports: a) Characteristics to be inspected b) Method of inspection c) Measuring and test equipment information d) Responsibility for the inspection e) Acceptance or rejection criteria f) Identification of required procedures, drawings, specifications, etc...g) Signature or initials of inspector h) Record of results of the inspection The personnel performing these inspections are examined andfcertified In their OlSular category.
Current qualification and certification f'les are qach Inspector.
IlDE inspectors are certified in accordance with required codes and stanilards see 17-1 Regulatory Guide 1.58). Written procedures require the tesarid .0ifi1cialskotftspiOrs in other categories such as Mechanical, Electrical, and $tructurol ao d0 'xp tin Ap=(r'fit QA manual. For cases where inspectors will Wperfr !imitd fut wn a?04'.are tested and certified to those limitations.
These ins wed tf inspections specifically defined In this limited certification.
I For inspections of ooncrete containments, IersonOlfM A,"*shall be a Registered Professional Engineer e c et-1i, of structural concrete and knowledgeable of the and constru coes ard other criteriaused in the design arMd constnmuLton of ff onect ft Ar It Responsible Engineer may also perform inspections as discussed in thleftiomft
-Certificti6on procedures and certifications are Uppr6ved-by rhon Owednol responsible for thee pre .These procedures 0 with the r rquir rnt* 9 applidable codes and standards.
Amendnient 40 1-3 17-36i The inspection criteria for performing inspections are established from codes, epciicatkos,.
and standards applicable to the activity.
Examples of activities subject to inspection Include -.a) Activities specified by the ASME Code Section XI b) Special processes C) Modifications d) Maintenance e) Material Receipt Inspection recuirements'for maintenance or engineering changes are equivalent tothe original desljfi andinspectli6n requirements, or acceptable alternatives.
Mandatory inspecti~on held points are inicluded in the documents addressing the activities being performed, as neceesari", and work does, not proceed beyond such hold points until satisfactory completion of the -required inspection, .disposition of any item not meeting the acceptance criteria, and any required *reinapection.
.After inisp&data Is collected and reviewed by'the inspector, the repoits are technically reviewed by personnel designated to perfor-n that QA function.Insi n s involving the supplier QAP are evaluated and approved by NOS-Procurement Quality.17.3.2.13 Corrective Action Station personnel are responsible for the implementation of the QAP as it pertains to the performance of their activities.
Specific to this responsibility is the requirement for informing the responsible supervisory personnel and/or for taking appropriate corrective action whenever any deficiency in the implementation of the requirements of the program is determined.
Procedures require that onditions, adverse to quality be corrected.
In the case of significant.
conditions adverse to quality, the procedures assure that the cause of the condition is determined and action be taken to preclude repetition.
Perfoirmance and verification personnel are to:* ieeefy adverse to quality ... .....,-"~ "> .' r~ t'* ~v~~~.,d' o lutionsto the prbl a appropate.d, -* ob h o n s qp ria tem. ". .Adl:l .yft e are to ensure that reworlbd ' Ired, and rn i kooed k'*idti ohtfie "naTfinspection and;to For signil nident~ ing r.towhere a safety limit is exceeled, or whicht Sid,t~V~
i)h !apin~iwv1luaft 9f*iefM. fp the pnoidmt.,,." e'~am fl~~W orreefminfided as -It-df ftifeliddeIt..
17-,36 n 1736w~iAmencbiweei0
,-r ,
d) Describe, analyze and evaluate any significant QA Condition 1 implications of the incident.Such reports shall be, reviewed by the Nuclear Station Manager (or for the Nuclear Station Manager by: 1) the Operations Superintendent, 2) the Maintenance Superintendent, 3) or the Work Control Superintendent, as previously designated by the Nuclear Station Manager) and approved by the Manager, Safety Assurance.
Such reports shall be provided to the Site Vice President, the PORC, the NSRB, and the NRC as required by applicable regulations.
Outstanding corrective action commitments made with regard to such incidents are identified and periodically reviewed to assure that the identified corrective actions are properly completed, and documented.
An identified corrective action commitment is closed'out upon written .notification by a cognizant, responsible individual or other written documentation, of the,.satisfactory completion thereof. Closure of corrective action commitments which specifically involve other Department(s) require written notification by the other Department(s) of the satisfactory completiqn thereof.All violations of Technical Specifications, safety limit violations, and all other reportable events shall be investigated and a report prepared which evaluates the occurrence and which provides, recommendations to prevent recurrence.
Such reports and other special reviews and investigations shall be reviewed by a knowledgeable individual/organization other than the individual/organization which prepared the report. Reports of safety limit viplatins shall be reviewed by the Nuclear Station Manager and the Operations Superintendent.
A knowledgeable individual/organization shall review every unplanned onsite release of radioactive material to the environs and prepare reports covering evaluation, rec60*encati6ns, and disposition of the corrective action to prevent recurrence.
All special reiAews and investigations, and the preparation of reports thereon, shall be perfor dj'ay knoqwledgeable.
individual/organization.
Electronic processes are used to track, trend, and to facilitate in the resolutionof site pmblerns.Additionally, these electronic processes are used to measure and classi,.mulear penawato.Identified problems are considered for generic implications.
MoAthly .ipoftre-pessned electronically and are also provided directly to senior management ndm N8RB -..Discrepancies revealed during the performance of station operation, marl mw #Ape~I on, and testing activities must be resolved prior to verification of the competion oft-hW alvittbelf.
performed.
In the event of a significant malfunction of QA Condition I pptrucur~s, , arid components, the cause of the failure is evaluatedarnj a priat'at Items of the same type are evaluated to determine Whedther-not'thin be e -pOted .d1 continue to function in an appropriate manner. This evaluation I ocumei"r ed in accoribre e with applidable procedures.
QA Condition 1 materials, parts and componenit Wh*ch e 3o r'r! e identified, segregated or otherwise controlled (e.g. Oy a c dl e tiAri as to preclude their inadvertent substitution for And use As conforming parts A6i0 components.
The'determination of an item's nnCo formfh 1, iuet lted Issk.S file by Nuclear Generaon and, as apprdatle, by tags6 clih e iem; NuWea. r, Generation personnetare notfied of anynanoonfdofmancoesidu
- tdin awm~lm* ith approved procedures.
Nuclear Generation maintains a listn§ of twe sttu of all 0 -a reports, when complete, identify th no cnfrmg materiat, p Ot "MPM0 t; a cofea h inspection requirements; and the resollitin.
and:
fernmanae.
Provisions are established for identifying those pemonnel with the reeoneibillty ad uthQfi for approving.
the resolution of nonconformances.
Unti a detemdrnawon of bonfonroam.is
-Amendment 40 .73.17-37 ,-.:-*i made, a QA Condition I material, part or component cannot be placed in service. Tags which are placed on items to identify nonconformances are removed upon resolution.
Information relating to nonconforming materials, parts and components is analyzed by Safety Assurance to determine if any discernible trends which might affect quality exist.' Wheh recurring nonconformances indicate possible supplier deficiencies, such information iS considered in evaluation of supplier acceptability by NOS-Procurement Quality.'Significant trends will be/are reported to appropriate levels of management 17.3.2.14 DcUnment Control The policies and instructions governing activities associated with DEC's nuclear stations are contAieo164 appropriately controlled manuals, which identify the various departmehts' performing' these aktivities.
These activities include measures to control the issuance of documents such as, instructions, procedures, and drawings, and changes thereto, which presefbe aldtovties affecting quality. As identified in Sections 17.3.1.3 and 17.3.2.1, these doc~unt dveloped and approved by the organization responsible -for the activity.
These.documents'we coftelled documents distributed electronically and/or hardcopy by distribution indices.The stadtio Fac~ity ating License and Technical Specifications are considered NRC controlled doc.qfients .are distributed within DEC by appopratey authorIzed personnel unrtlhe c9 i, te oftthe, ste manager responsible for regulatory affairs. Proposed changes toth " ,9~*ting License or Technical Specifications shah be preparedinfinistrative -controls by a knowledgeable individual/organization.
Each prdý d changes'hafl be reviewed by a knowledgeable individual/organization other than the individual/organization that prepared the proposed change. Proposed changes to the stMOtW WFsWiyeg~EIC..se Tsechnical Specifications shall be approved by the INo Nuclear Station Manager by a designated manager or corpcra*aW.6mkWSeal Ow lietters for proposed changes to the station Facility Operating License and T lilda clf'tion ~halbe -signed by an officer of Duke Energy Carolinas.
Ropofts a*considered controlled documents and are distributed by cover lsucgmm. SbVice Noe .'nt hbis designee.-.
Tqrnc~~~udirig t mna s n 4blow sPecify the requ approv~1, ...co~itr 1, and use Of manua and pr tuuoients con~alned Within e Topical Repott.The contrle plcie- and procedures also provide the governing procedures for the NOS-S an. Q,, d thp .NSRP. The proeures gQ9emgNOS and theNS1B8 il361 1ontin the poolices and pmcdurw thatiaonorl-nuclear promuahintnwdaS
-F, fs .,TlW.r*nmpwcas requirement&son
,,.departmoMs 4lWve VxcWuawd.
ist if sl dW in oeqrenst:
i Nuclear Supply Chain. I assesieted wV QA
.1srut ; ser and -m i is ots **si e sb ke .c ,iviW exam."M le*=Frince with activity4, *esviy v 0na&%ftn must exit prior to and dufig perormanceo an activity, and: 17-38 1 f,- " , i 1738~r~tAmend"~t
.4, .) i include quantitative and/or qualitative acceptance criteria, compatible with any applicable design specificatibnS, for determining that the activity addressed is satisfactorily accomplished.
Also, the procedure will require independent verification by qualified personnel of the performance of specific procedural steps. Examples of documents established concerning quality related operational activities are: a) Preoperational Test Procedures b) Periodic Test Procedures c) Operating Procedures d) Emergency Procedures e) Maintenance Procedures f) Instrument Procedures g) Radiation Protection Procedures h) Alarm Responses, i) Chemistry Procedures j) Process Control Program Implementing Procedures k) PORC Implementing Procedures
') Abnormal Procedures m) Emergency Response Procedures Procedures are reviewed for adequacy based upon: lessons learned frbmorf mal use, aUditS, unusual incidents (such as an accident, unexpected transient, significant operator' eiro, oa equipment malfunction), station engineering changes,.the operating expernloce ptram, root cause analysis, or the corrective action program. The frequency of re~ieWior Abr 1.t ;Procedures, Emergency Procedures, and Emergency Response Pdf6euieb Sh" nof 6xcedd six years. Procedures that have not been used for six years'Shall be bef6rerbsfe t6 determine if changes are necessary or desirable.
Reviews of prfbetre c be 6d in several ways, including (but not necessarily limited to) y-tep u- e o he procedure (such as occurs when the procedure has a ster.by-4t0,ceekWnbssocieted wIvtlh~),.
or detailed scrutiny of the procedure as part of a documented trafr'*ý pr wdrl, ýir te" exercise, or other such activity.
A revision of a procedure cart 6ofttitea dUre "w.'A knowledgeable individual/organization shag review. changesa-o the P.roqsW: PQolnf-j'r, Offsite Dose Calculation Manual, radiological effluent controls of the'UFSAR, and radwaste treatment systems. A knpowedgeabe' s~tl" tht* PW PetO " Programi and rimplementing procedureS.
Changes to the tltMM ehe.be reviewed for acceptabilityby-eithet the Radlatioh Protectloh MairfadeftiF 'Statl Manager. .In additiorn
- t to abov%, ilg of drawingsa ppo r apl)lbd .t0 #0e.! '.structures, systems and-'owponents are mnta~ped ateach anclea statioq and ae 4, 9 appropriate, in the performance of quality related activities.
Statioh p(0oecDures Which address aOOivti, ateadý qhn, d , -.1 SQUctu , --I110" and components are subjeted to a we --*,und h~ nj,r *a.*,I ,-approval proess. This process inclydes; the reqoement that Ixqc*dvmWy&
- e.p-pad bXR :.knowledgeable individual/orgarization.
This prago5 also includes t rql~lrwit
- ,at V,, go procedure be reviewed for adequacy by an individual/organization other than the Amendment 40 1 17-39 ý- r. ,
individual/organization which prepared the procedure.
As appropriate, such procedurs are.,. -., also~reviewed by personnel.
from the Nuclear General Office, by other departmens within-the:, Corporation, by the NSRB, or by vendor personnel.
Individuals responsibW#tfr produe*. -reviews and reviews of changes to the radiological effluent controls of the UF,-R perfoimed in, accordance with this Section shall have been previously designated by the Chief,,Nwlear-Officar or direct reports, or Site Vice President or direct reports to perform such reviews and have as a.minimum a high school diploma or equivalent and four years of technlcalexperdi~ci.
Review of environmental radiological analysis procedures shall be performed by themanager of the environmental laboratory, or designee.
Each such review shall include a determination of whether or notadditional, cross-disciplinary, review is necessary.
If deemed necessary, such review shall be performed by the appropriate designated review:personnel.
Reviews -performed in accordance with this Section shall be documented.
Approvals shall be by the Sie Vice President or his/her direct reports or one of their designees.
Each procedure and changes thereto, shall be reviewed and approved prior to implementation.
Temporary changes to procedures may be made provided:
a) the intent of the original procedure is not altered; and b)-the change is approved by two members of the plant management staff, at least one of whom holds a Senior Reactor Operator License on the affected unit; and c) the change Is approved by an appropriate division manager, superintendent/manager, or one of their designated direct reports within 14 days of implementation.
For-procedures which implement offsite environmental, technical, and laboratory activities, the above approval may be performed by the manager of the. environmental laboratory, ordesignee.
Maintenance, instrumentation, and modification procedures are~reviewed by cognizant station personnel to determine the need for inspections.
Procedures developed and implemented for inspection identify the certifications, inspection methods, acceptance criteria, and provide means for documenting inspection results.In case of,pl; n ,tWives of a norp-recurring nature, e.g., preoperational tests, only an original cqpof apgod.procedure is available for use. Such copies are controlled and are replW
- prth po" is superseded by a new issue.. For. activities which are of a recurring Fr, il tetg, current original copies of approved procedures are malp~ilip
.
m r. Copies of these original copies are then utilized in the POO ., Whenr'uch "working copies" involve the documentation of in th procedure, the "working copy" of the pr a.atdil'= pý2,24the applicable orginalcopy to assure validity.
Station ip 111N AW! xnc4 provide means to document this comparison, Such.See, n 17.3,2,15, "Records." When recurring work acti~q~4 p Idac~~entto.9f, qqmpli~nce with Wceptance criterr4 within the procedure, e.g., certain operating activities, issuance of the applicable "working copies"is D *.a .d -." .:thereto, are norm ., .arhe utilized for, ofpp ;l, jr: p , their, IP!p.F d.b.tir.and use. A master f drawings is maintained and a master index, updated regularly, is u t identify drawings, revisions, number of copies, and distribution.
Design and procurement marked superseded.
~ o~~ co W~~ ~h~fl~is ~n~Itt he tocu~nthtt6ntrot aliee of each station P oitrlbtd ""A wMation ddct#Ment e6mti el.uti.izk,,tbt b .-1n:," ' " '- '. : r b an. .use-.'i' .S -. f " -.. .. anl 17,40 Amendment 40 ;-.
responsibility.
These station line organizations may directly issue control copies without issuancedirectly from Document Control personnel.
Document Control personnel will review the index of records periodically for station line organizations that maintain an index and issue control documents in this manner. Controlled documents may also be provided to station personnel by use of an electronic medium. Reviews are performed regularly and documented to assure proper functioning of the control system.17.3.2.16 Records Each nuclear station is required to maintain adequate identifiable and retrievable QA records.Records may be stored in electronic media provided that.the process for managing the stored data is documented in procedures that comply with applicable regulations.
Media used for .retention of records include (but are not limited to): microform, compact disk recordable (CD-R), and magnetic media including videotape, computer tape, optical disks, and hard disk storage.Electronic records retention must be an integral component of the Record Retention Program, approved by the management position responsible for Nuclear Generation Department records.'The format used must be capable of producing legible, accurate, and complete documents during the required retention period. Electronic approval and authorization procedures are established to assure that only those persons authorized grant the required approvals.
Such records are managed in a controlled and systematic manner by means of a station' Master File Index. Access to, and use of, this file is controlled.
Some records noted below rhay be generated by the Nuclear General Office and are retained at one of the nuclear stations.Records required to be retained include: a) QA Condition 1 preoperational testing records.b) Records of engineering changes to station QA Conditionr 1 structures, systems and components described in the Updated Final Safety Analysis Repq. .c) Radiation monitoring records, including records of radiation and .c)taminition surveys.d) Personnel radiation exposure records.e) Records of radioactive releases, shipments, and waste diSpo$a .f) Isotopic and physical inventory records of special nuceWar m~tefials.
g) Records of the qualifications, experience and training of appropriate sation personnel.
7 h) Current calibrations for measuring and test devie...i) Copies of approved purchasing documents for items 'requiring QA certification.
j) Maintenance histories on QA Condition I instrumentation and mchanical, a. s ,u u .s, s, t ., and .o.i.o* .eht& " .: .-'k) Records of speciaal.processes affingQA ond'dioo I structuts, 4stems and components.
I) Copies of purchs. specifications..
-m) Operating records and logbooks coverng timkftrVAg8t4oV0,we l, including:
switchboard record, reactq/ operator.
logbook..
and!shift.supervisor koQ.n) Periodic testing records.Amendment 401 17-41 "i ,: -'I o) Records of inspections.
p) Copies of approved and of completed station procedures, and changes thdeto including review and approval documentation.
q) Copies of audit reports received from the NOS-Audit section, andiresponses thereto.r) Copies of drawings, design specifications, calculations, design analysesi, and v~ndor documents.
s) Copies of reports of all reportable and other significant events.t) Records of in-service inspections.
U): Records of quality control inspections.
v I) su;h as vendor documentation'packages and inspection reports, piping isometric drawings, welding records, etc. compiled during the design and construction of a nuclear station.w) Records of the oualifications of quality control and other appropriate personnel.
,6) Rord's of Off-site environmental surveys.,:y) Rcords of special reactor tests or experiments.
z). Re,,rd of environrnental qualification.
ab) l6,ords Of theservice life of all snubbers, Including the date at which seal service life commences and associated installation and maintenance records.ab) Records of the reviews performed for changes made to the Process Control-rognrm, Offslte Dose Calculation Manual, and Radwaste Treatment Systems.ac) By-prodd*
utilerlat inventory records.' quid Af, fent, daseous effluent, and gaseous process monitoring instrumentation alarm/trip setpoints.
ae) Records of sealed source and fission 'detector leak tests and results.af) Records oV inriii isfcal inveitory of all sealed source material of record.ag) Record'&1 adr :fuel inventory, fuel transfer's, and assembly bumup ah) Records of review performed for changes made to procedures; or modifications to station structures, systwsvs end components; m.reviews of 4ests and experiments
- ,ptqrpant.
10OCFR50.59.
p% Reor f r water amplng .nd water quality. .aj) Records of analyses ;nsplvirnt rirg Program , th w9uld Vrnit eyaluaon of the acy of the analysis at a later date. This' iddoge V 1 eieove'l ap etfe -*imts ; A r showirg that these procedures were followed.ak) Records of component cyclic or transient llmits est4bi9*tdl f* th" re coolant al) f rfr e1r ,hahges rhade toatbiiEl erfE Controls.17-42 t 1;17.2 ~-~'Amendlitentl*--
am) Records of reviews performed on the Fire Protection Program and implementing procedures.
an) Calibration standard records and Measuring and Test Equipment (M & TE)calibration records.Test, inspection, and NDE records for QA Condition 1 structures, systems, and components are maintained by the station and contain the following:
a) A description of the activity, performed.
b) The date and results of the activity.c) Information relating to discrepancies identified with regard to the activity.d) An identification of the data recorder(s) or inspector(s) involved in the. activity.e) Evidence of the completion, and verification thereof, of the activity.f) An identification of the acceptability of the results of the activity.Records of activities within the purview of the NSRB are maintained.
These reoords include: a) NSRB meeting minutes.b) Audit reports for audits conducted under the cognizance of the NSRIB.Records of activities within the purview of NOS-Performanceeare maintained.
Thems rdcorft include: a) Records of assessments performed on station advities.b) Records of special reviews and investigations.
c) Copies of special reports.Records of activities within the purview of the PORC are maintained.'
The re s dpc*nnt the meetings of the PORC for each site. These records include: a) Identification of the chairperson for each meeting.b), A listing of the PORC members present at each meeting.c) A listing of others present at each meeting.d) A summary of the items/issue(s) discussed during each rneeting.e) The decisions/approvals reached by the POAC during e Ch Records of activities within the purview of the Nuclear General Office are'r haht ned. These records include: ...a) Supplier audit reports and smveilances.
..-b) Audit reports of Duke EneW Corporation activitke..
c) Audit and Supplier personnel qualification records.d) NDE inspection personnel certification records. ' i;,!' ' A ,c e) Laboratory QA records. :.Records for major station projects will be maintained at that station as appropriate.
These records include: -..2 .a) Copies of procurement documents.
Amendment 40 17-43 -"
, b) Copies of vendor documents.
Records of activities within the purview of the department interfacing organizations are :.:.maintained by these departments in a manner similar to that described above fo~rstion QA records or transferred to the station, as appropriate.
These records include: a) Laboratory QA records.b) Environmental records.c) Software requirements.
d) Softwaretest plans,.e) So1tware test results.f) Prograrr'odule specifications and'source codes.Dry cask storage records pertaining to the design, fabrication, erection, testing, maintenance, and uem of structures, systems, and components important to safety must be maintained until the NRC terminates the license or Certificate of Compliance.
The retention times for the various QA records arein accordance with. corporate retention policies,.
The de4elopment of these retention policies includes applicable requirements, incluoing thooe of the Coie of Federal Regulations, a station's Technical Specifications, established national codes and standards, and regulatory guidance as listed in Table 17-1. To the maximum extent practicable, records are stored such that they are protected from possible destruction by causes such asfIte, flooding, theft, insects and rodents and from possible deterioration due to a combination of extreme variations in temperature and humidity conditions.
Record storage areas shall be evaluated by a qualified Fire Protection Engineer to assure the r ors are ad:qatey rotected from damage. The evaluation shall include the following con'Wiatdolohi A i Kmum:' .. -. ..a) Structural collapse.b) Unprotected steel ,(s s.n4.ed floor slab or roof).c) Fire frequency of similar occupancies.
d) Quantities "ofl.utble materiais.
e) Ceiling,:,sg.
h n contpfigurjW which ,would contribute to heat dissipation.
g) Fixed fire suppression systems.h) On-site fire fighting organizations inctdu Avakb* equipment-This evaluation shall be documented 10evh nKord ad&tRsgea tefUite locations).
'- ..,, , .,, ,. .17.3.3 SELF ASSESSMENT
....,.17.3.3.1 Methodology
"'The Self-Assessment process encompasses internal and corporate audits, indepaWe, review committee activities, in-plant reviews, and other independent assessments.-
This process is to 17-44 q r:-t 17-44 ~Amendmnegg44
-,
confirm to management that activities, affecting quality comply with the QAP and that the QAP has been implemented.
effectively.
The assessment activities are performed in accordance with instructions and procedures by organizations independent of the areas being assessed.Organizations performing self-assessment activities are technically and performance oriented, with the primary focus on the quality of the end product and a secondary focus on procedures and processes.
17.3.3.2 Assessment 17.3.3.2.1 Nuclear Safety Review Board The Chief Nuclear Officer appoints a Nuclear Safety Review Board (NSRB) to serve as a nuclear safety review and audit backup to the normal operating organization.
The NSRB shall function to ensure independent review and audit of designated activities in the areas of: nuclear power plant operations, nuclear engineering, chemistry and radiochemilstry, metallurgy, instrumentation and control, radiological safety, mechanical and electrical engineering, and administrative control and QA practices.
The Chair, members, and alternate members of the NSRB are appointed in writing by the Chief Nuclear Officer and shall have an academic degree in an engineering or physical science field;and in addition, shall have a minimum of 5 years technical experience, of which a nitihmurri 6f 3 years shall be in one or more of the above areas. in special cases, candidates f6r app601biient without an academic degree in engineering or physical science may be qualified with a ý -, t, minimum of ten years experience in one of the above areas. The NSRSB shall be compoedof at least five members including the Chair, which constitutes a quorum. Alternate Chair/Members may replace Regular Members as necessary.
Members of the NSRB may e from theNclear Generation, from other departments within the Corporation, or from ete'rnif to the Corporation.
A maximum of one member of the NSRB may be from the nuclear site staff for which A idview is being conducted.
Consultants shall be utilized as determined by the NSR8.Chair to provide : expert advice to the NSRB. Staff assistance may be provided to the N$RB in order lopmo'.t the proper, timely, and expeditious performance of its functions, I ...." .I .... ...I. ... ...The NSRB shall meet at least twice per calendar year. The NSRB shall endudo"tde ent reviews of and provide oversight for the following items: a) The evaluations for: (1) changes to procedures, enuipnre~rk, "or "Stel U , () tests or experiments completed under the provision of i0CF6 tou actions.did not require a license amendment I RSO...;b) Onsite safety review function (PORC).c) Review reports that describe violatlens of Codes,, rMjtstv ao m~e, Ts&#W'c Spedifications, license reqtlrements, or Oflihtohal oi*61s1ttm6nef nutlear safety significance; d) Review reports that describe significant operating abnormalities or deviations from normal and expected performance of unit equipment that affectrnuclfr safety.;e) ýReview reports that describe rportabl events;1) Review reports that describe all recognized indifatoflon of ait tikafhtlt
&te delbic in some aspect of design or operaltli of strwtums, sstawr or a.i.ons "*could effect nuclear isafety; and g) Review reports that describe QAP audlts4rla~tingtl S t'tr orpenlrig rij taken in response to these'audits.
Amendment 40 17-45 .,,'-
Reviews may be conducted by an organizational unit, subgroUp, or member of theNSRB. In, either case the review body will collectively have requisite knowledge, experlence; and competence to perform reviews in the above areas. Organizstionsdndlviduals/grcops:
conducting these reviews will functionally report to the Chair of the NSRB. ' .The NSRB shall report to and advise the Chief Nuclear Officer on those areis ofrespoh.sibW*ty specified in Items (a) through (g) above.Minutes of each NSRB meeting where a quorum is required to be present,-shalt be prep~ir(, d approved, ancd forwarded to the Chief Nuclear Officer and to the Site Vice Presidents within 30 days following each. meeting.17.3.3.2.2 Plant Operations Review Committee Each SiteVice.
President appoints a Plant Operations Review Committee (PORC) to review select~~~a safety related issues. The PORC is composed of specified senior members of the site maagemernt team most responsible for the safe and reliable operation of the station.The PORC afso reviews corrective actions for specified reportable events. The PORC shall review and recommend approval of items requiring NRC approval prior to station approval for riipb~ation.
- rThe, reviews shall Include: a :'rpao %,,ags to procedures, equipment or systems which when e~aluated under the IprQM,4!:iQI, p 19 .q.RF0.59 require a license amendment pursuant to 1OCFR50.90; b) Proposedtests b experiments which involve a license amendment pursuant to, 1OCFR50.90
,'U r in -RsO.65:' and c a, , t0,thp stations' Facility Operating Licenses, including Technical 4 if" i r ' tMV 06 lentation except in those cases where the change is identified
~e~ie y ~~9$9~change
"' I ', , * ,.in dis-O g t r&#W06W t review responsibilities, PORC shall keep safety considerations or schedule considerations.
Should a voting member have direct responsibility for the preparation orutechnical review of the Item requiring PORC inde:%" .corAfL qof such considerations is likely, that member shall be repl36d(to ano her voting member.
rv',w. reep, nsabllities the PQRC shall provide meeting minutestej with" , queetio-p/~s den~ ign, incliddn~g the bas~is f or de~termination made.17.3.3.2.3 Independent Nuclear Oversight The A q. Ann supportjo n ,qers for. tho W$wing~ Qupty, Qc~on endNQC.Pprf~ace.
Responsibilities for NOS-Inspection, described in Section 17.32,,12
.th. othqr; nctions descrlbed boeow..A lM, , ... ., The DEC QAP requires a comprehensive VltWfOftafrnfd Ui odlc iumemat1i'dftror all All W mPoitg =j).5 7 atinfw om These audits are performed to determine the effective impleroweia fe.pal'able crtedria of.o PRc "pgP 'itiresr re F9ds 0 f procpkes (e.g.., welding, marnenance, 'dbvle ient o esign, record managoemet, or system 17-46 el,6,.`' k AmenduWh40
..
complianoe'and effectiveness of the implementation of the QAP are performed.
Internal audits are initiated under the direction of the NOS-Audit manager. The NOS executive may initiate special audits or expand upon the scope of an existing audit. The scope of each audit is -determined by the responsible Lead Auditor, under the direction of the NOS-Audit manager.Additionally, the scope of audits performed under the cognizance of the NSRB is reviewed by the NSRB staff. The lead auditor directs the audit team in developing checklists, instructions, plans and in the performance of the audit. The audit shall be conducted in accordance with checklists; the scope may be expanded upon by the audit team during the audit, if needed. One or more persons comprise an audit team, one of whom shall be qualified lead auditor.Audits of site activities shall be performed under the cognizance of the NSRB. These audits shall encompass:
a) The conformance of each nuclear unit's operation to provisions contained within the*.- Technical Specifications and applicable Facility Operating License conditions; b) The performance, training, and qualifications of the entire station staff;'c) The results of actions taken to correct deficiencies ocrurring in unit equipmerj.
structures, systems, or method of operation that affect nuclear sarty;", d) The performance of activities required by the QAP to meet the critoria of 1OCFR50;Appendix B;e) The Emergency Plan and implementing procedures;
...... ..f) The Security Plan and implementing procedures; g) The Facility Fire Protection programmatic controls including the implement:r;, procedures; h) The fire protection equipment and program imp.er. en ttiri, ullng efrh e I' qualified offsite license fire protection engineer or an o'utside lindependent flr prote consultant.
An outside independent fire protection ct.nsulnt si!, ll.used t least.every third year;i) The Radiological Environmental Monitoring Programt ad.. teres8 tserf, ,., j) The Offsite Dose Calculation Manual and impl~mritirg procedm.evi k) The Process Control Pr(*rat and ineietlnng dieoi 8 lc dIbt :i radibactive wastes;I) The. performance of effluent and enwvironrnm9ntpIaJlrP
!j9lipg ,$ ;. -m) Any other area of Site operation coflsldered apptapftf M*ef Nbces. Officer; .... * .... -.. .. ....n) The ftdepability bf t #"tiesntstlve s s chW-f1fit.fev~f LF~~Jrg effectiveness bfthe Otocedurdreview btW 't6 'f,',.Audits of selected of Qer$onal p..l a6*6-taig*
roj. 40, %S -9d, commensurate with safety significance and in such a manner as to assure that an au It otall QA ConditiOn t fuftcetlons-l pe wlthlha ~petdof twoi(2) '. co I" frequency is specified by regulation, the following criteria for extending audit intervals a 1). ,Schedules shall, be based on the month in which the audit starts, ,.. .... .... ......* .... ;.' , Amendiftet 4&', `74~17.47-'..
- 2) A maximum extension not to exceed 25 percent of the audit interval shlM, b* ok (e.g., audits on a two year frequency shall not be extended beyond 3.,omatl -audits on an annual frequency shall not be extended beyond 15 months), .3) When an audit interval extension greater than one month is used,,the next dWlt ,'r that particular audit area shall be scheduled from the! original' anniversO ri"h rather than from the month of the extended audit.The audit system is.reviewed periodically and revised as necessary to assure coverage commensurate.
with-current and planned activities.
The audit~team concludes withta post-audit conference ibetwpen the audit team. and responsible-management.
The conference includes a brief discussion of audit results, including any defigienies and r Commendations, The audit results are documented in a report.Within thirty (30) days of the, post-audit conference, a report is issued to the responsible management with popies ,ent to the Vice President of the audited Site or department, the Chief Nuclear Officer ahd other 'ianagement as appropriate.
Within thiif:týdy aAfte re6lptfbf the audit 'rep6rt, responsible' management replies in writing to the NOS-Audit m96*d r,"describfffg corrective action and an Implementation schedule.
The estobkW electron corrective action process may be used to convey this information.
When necessary, after receipt of the management reply, a re-evaluation is made to verify implementation of corrective action. This re-evaluation is documented.
The audit is closed with a letter to audit management.
All pertinent correspondence, chedktists, and reports related to the audit are filed.Audit Ih resulting reports on the effectiveness of the QAP, including any quality problems, are reported to management for review and assessment through periodic T i his data is also used to modify the audit schedule as eI k r te.ses..
Supplier QA programs are evaluated and monitored by NOS-Procurement, to assure that QA requiremM"'
i 10Wf` Sth0#0 QAkians reqjire a system of periodic and planr'ed supplier and sub-supplier aud n, e ,persons not dir."tly invlved in the activity being audited.DEC pmvj for su.4poe, evauation and approval of sub-suppler supplying items and services.
This assurance is accompUshealby reiewing supplier audits of sub-supplier as part of the pre-bid audit, by making supplier control of sub-supplier work a crft";%* ffiooirl'&
br'dIWat0vK,zedd by -fading duoo*er sun ~ pj~~qjiWtW spucasrsw*
The NOS-Procurement Quality maintains surveillance and performs audi'dn
- rffi s' QA prog Mo.*^perons are in compliance with S ,OJM A tqfl. lb ¢ase of .n aur4of a lippipr, any deficiencies noted by the auditor are clea outlined in writing and qiven to the supplier's QA organ ~ ~ t e~eIs 17.3. 2.31 NSPerfofmance NOS-Performance aessmenig, bb.sefaions o 9d ' 4e bfs ccties, and processes on the basis of their impact and importance relative to safety. Assessments can be focused on areas most In need of improvement.
An annual assessment of PORC 17-48 t,-
effectiveness shall be conducted at each site by NOS-Performance and the results shall be reported to appropriate management and the NSRB.A documented plan or agenda identifies an assessment scope, requirements, assessment personnel, activities to be evaluated, organizations to be notified, applicable documents, and schedule.An annual schedule for assessment activities at each nuclear site shall be established by NOS-Performance personnel and approved by the NOS-Performance manager. This schedule should be reviewed every six months to adjust for emerging trends and major changes in processes, procedures or personnel.
Experienced and qualified personnel perform'assessments and are familiarwith written procedures, standards, and processes applicable to the area being evaluated.
NOS-Performance personnel shall have sufficient authority to make ther assessment process meaningful and effective and shall not have direct responsibilities in the areas to be assessed.They shall have access to plant activities and records necessary to fulfill their function.An assessment team leader shall organize and direct assessments and ensure the team collectively has the required experience or training for the activities to be evaluated.
The assessment report shall be performed in accordance with approved procedures.
The report shall include a description of the assessment.
scope, a summary of the results, and a description of each concern identified.
Assessment results are communicated to the appropriate site managerial level of the organization having responsibility for the area or activity assessed and are documented in the corrective action program. Concerns requiring prompt corrective action are reported immediately to the management of the audited organization and entered into the electronic corrective action program.Assessment results are documented and periodic reports are provided to senior leadership at each site. Associated documentation is on file at the appropriate location.
Personnel qualifications records for assessment personnel are established, maintained and reviewed.17.3.3.2.4 Corporate Audit Corporate audits are initiated and directed by the Chief Nuclear Officer. This audit is performed within a period of two years on the DEC QAP.The Chief Nuclear Officer selects the audit team and appoints a team leader. The audit team consists of at least three qualified individuals, none of which is from the area audited.The scope of the audit is determined by the Chief Nuclear Officer and the audit team. Each audit includes a review of internal audits performed by the NOS-Audit.
The audit is performed with pre-approved checklists, instructions, or plans.The audit team conducts a post-audit conference with the responsible management of the area audited to discuss the audit results, including deficiencies.
The audit team prepares checklists and the audit report. The report is sent to the Chief Nuclear Officer.The Chief Nuclear Officer and/or responsible management of the area being audited determines the need for corrective, action and re-evaluation.
Necessary corrective action and re-evaluation are performed as required.All pertinent correspondence, checklists, and reports related to the audit are filed.' " ' -:.. .r: , Amendment 44*, 1.17-49 J, rý-.
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- %, 1740 Amend1740 4 ......-