ML17109A487
| ML17109A487 | |
| Person / Time | |
|---|---|
| Site: | Palisades, Indian Point, Grand Gulf, Pilgrim, Arkansas Nuclear, River Bend, Waterford, Big Rock Point, 07100240, 07100341, 07100536, 07100566, 07100604, 07100937  |
| Issue date: | 04/10/2017 |
| From: | Limpias O Entergy Nuclear Operations, Entergy Operations |
| To: | Document Control Desk, Office of Nuclear Material Safety and Safeguards, Office of Nuclear Reactor Regulation |
| References | |
| CNRO2017-00006 | |
| Download: ML17109A487 (91) | |
Text
Entergy Entergy Nuclear Operations, lnc Entergy Operations, Inc.
1340 Echelon Parkway Jackson, MS 39213 Tel: 601468-571 1 CNRO2OY 7-00006 April 10, 2017 U. S. Nuclear Regulatory Commission AUN: Document Control Desk Washington, DC 20555-0001 Oscar Limpias Vice President, Oversight
Subject:
Annual report for Quality Assurance Program Manual changes under 1 0 CFR 50.54(a)(3), 1 0 CFR 71. I 06, and 1 0 CFR 72. 1 40(d) Notification of Application of Approved Appendix B to 1 OCFR72 subpart G.
Arkansas Nuclear One (Units 1 & 2)
Docket Nos. 50-31 3 & 50-368 License Nos. DPR-51 & NPF-6 Docket No. 72-13 Docket No.: 71-0341 Grand Gulf Nuctear Station Docket No. 50-416 License No. NPF-29 Docket No. 72-50 Docket No. : 71-0536 River Bend Station Docket No. 50-458 License No. NPF-47 Docket No. 72-49 Docket No.: 71 -0566 Waterford 3 Steam Electric Station Docket No. 50-382 License No. NPF-38 Docket No. 72-75 Docket No. : 71-0604 Palisades Nuclear Power Plant Docket No. 50-255 License No. DPR-20 Docket No. 72-07 DocketNo.: 71-0937 Indian Point 1 Nuclear Power Plant Docket No.50-003 License No. DPR-05 Docket No. 72-5 1 Docket No. : 71-0240 Indian Point 2 Nuclear Power Plant Docket No. 50-247 License No. DPR-26 Docket No. 72-5 1 Docket No.: 71-0240 Indian Point 3 Nuclear Power Plant Docket No. 50-286 License No. DPR-64 Docket No. 72-5 1 DocketNo.: 71-0240 Pilgrim Nuclear Power Station Docket No. 50-293 License No. DPR-35 Docket No. 72-1044 Docket No. : 71-0240 Big Rock Point Nuclear Plant-ISFSI Docket No. 50-1 55 License No. DPR-6 Docket No. 72-43 Docket No.: 71-0240
CN R020 I 7-00006 Page2of3 Ladies and Gentlemen:
Entergy Operations, Inc. is submitting the attached Quality Assurance Program Manual (QAPM), Revision 32 in accordance with 1 0 CFR 50.54(a)(3) and I OCFR71.1 06. Revision 32 has an effective date of April 1, 201 7. The last annual submittal, dated April 4, 2016, encompassed QAPM Revision 29. Since that date, there have been three updates incorporated to the QAPM. A synopsis of each revision is provided under Attachment A. The 10 CFR 50.54(a)(3) and 10 CFR 71.106 evaluations are included under Attachment B. The Entergy QAPM Revision 32, which also reflects Revisions 30, 31 and 32 is included under Attachment C.
The QAPM continues to satisfy the requirements of I 0 CFR 50 Appendix B and the Regulatory Guides and ANSI Standards referenced in the QAPM Table of Contents and QAPM Attachment, Table 1 As such, it also meets the requirements of I 0 CFR 72.1 40(d) for independent Spent Fuel Storage Installations and 10 CFR 71.1 01ff) for Packaging and Transportation of Radioactive Material.
This letter contains no regulatory commitments.
Should you have any questions, please contact Mr. Edward D. Harris, Manager - QA at (601 ) 368-5649.
I declare under penalty of perjury that the foregoing is true and correct; executed on April 7, 2017.
YOur OL/EDH/NWE Attachments:
A. Synopsis of QAPM Revision Changes Revisions 30, 31 and 32 B. QAPM Revision 10 CFR 5054(a)(3) and 10 CFR 71 iOG Evaluation Forms and Affected Pages C. QAPM Revisions 32
CNRO2O1 7-00006 Page 3 of 3 cc:
C. Bakken (ECH)
J. A. Ventosa (ECH)
D. Jacobs (ECH)
L. M. Coyle (ECH)
- 0. Umpias (ECH)
J. Elnitsky (ECH)
J. R. Davis, (ECH)
R. L. Anderson (AND)
E. Larson (GGNS)
- w. F. Maguire (RBS)
M. R. Chisum (WF3)
A. J. Vitale (IPEC)
B. R. Sullivan (JAF)
J. A. Dent (Pilgrim)
C. F. Arnone (PAL)
B. S. Ford (ECH)
All above wlo attachments NRC Region I Administrator NRC Region Ill Administrator NRC Region IV Administrator NRC PM (AND)
NRC PM (Pilgrim)
NRC PM (PAL)
NRC Senior Resident Inspector (AND)
NRC Senior Resident Inspector (GGNS)
NRC Senior Resident Inspector (RBS)
NRC Senior Resident Inspector (WF3)
NRC Senior Resident Inspector (IPEC)
NRC Senior Resident Inspector (PILGRIM)
NRC Senior Resident Inspector (PAL)
PUE [C O SUO!S!AOd SO6UEqQ UO!S!AOd LAJdVO JO S!SdOUA9 90000L IOOdND V UWDEfl
Synopsis of QAPM Revision Changes QAPM Rev. 30 This revision corrects the titles in the QAPM to reflect generic titles remaining in lower case to be consistent with other responsibilities as defined in I 0 CFR 50.54(a) and added site specific Radwaste shipment docket numbers to the cover of the QAPM to align with I 0 CFR 71.106 requirements. Additionally, responsibilities of the senior vice president for nuclear operations were eliminated as those responsibilities now reside with the highest level nuclear executive (chief nuclear officer). The executives that previously reported to the senior vice president for nuclear operations now report directly to the chief nuclear officer.
QAPM Rev. 31 The Senior Vice President, Engineering & Technical Services position is being added to the nuclear organization, reporting to the Chief Nuclear Officer. The following existing positions will report to the Senior Vice President, Engineering & Technical Services:
I Vice President, Engineering & Technical Services Vice President, Major Fleet Projects Director, Nuclear Fuels The Senior Vice President, Nuclear Support Services position is being added to the nuclear organization, reporting to the Chief Nuclear Officer with the Vice President, Nuclear Sustainability Plan reporting to this position.
Additionally, this revision provides a clarification regarding the implementation of requirements for testing prepackaged non-shrink grout per codes and standards referenced in the QAPM.
Prepackaged non-shrink does not fall under the jurisdiction of Table B of ANSI N45.2.5 for testing requirements. The QAPM now states the designer is responsible for identifying necessary testing and frequency requirements. This change was submitted to the NRCas a reduction and accepted by the NRC via a Safety Evaluation Report dated September 13, 2016 as documented in ADAMS Accession No. ML16251A620 and Entergy correspondence CNRI 2016-00006.
QAPM Rev. 32 This change removes James A. Fitzpatrick (JAF) from the Entergy Quality Assurance Program Manual due to the transfer of the facility operating license to Exelon.
Attachment B CNRO2OI 7-00006 QAPM Revision 10 CFR 50.54(a)(3) and 10 CFR 71.106 Evaluation Forms and Affected Pages Revisions 30, 31 and 32
ArrAcHMENT 9.3 1 0 CFR 50.54(a) QAPM CHANGE EVALUATION FORM Page 1 of 6 Entergy QAPM Rev 29 Change No. 2 LBDCR 2Oi6O1 & LBDCR 2016-03 1 OCFR5O.54(a) Evatuation NOTE
- The basis for the answers should be of sufficient depth and detail to support the conclusions reached and allow for independent review. Simply stating the change does not decrease the effectiveness without stating why is not acceptable.
Editorial corrections (i.e., spelling, punctuation, typographical or grammatical errors, and incorrect cross-references) are not considered changes and therefore, a Quality Assurance Program Regulatory Review is not required. Alt boxes should be checked N/A and proceed to signature page of the evaluation form.
z[
YES ii N/A 1.
Is this change an editorial change as defined in 1 OCFR5O.54(a)(3)? (If yes, provide basis, mark remaining questions N/A and state not a X
X reduction in commitment) Proceed to approval (LBDCR (LBDCR pageofattachment.
2016-2016-01) 03)
Basis for Answer:
LBDCR 2016-01 Change the title Vice-President Nuclear Oversight in the Policy Statement to reflect a generic title to be consistent with other responsibilities in the Entergy Quality Assurance Program Manual (QAPM).
Site specific Radwaste shipment docket numbers are added to the cover of the Entergy QAPM to align with 10CFR71.106 requirements.
These changes are not a reduction in commitment.
The changes are administrative and provide clarification as allowed by 10CFR5O.54(a)(3).
2.
For any YES answer in the YOCFR5O.54(a)
Screen or for the QA-initiated change, does the proposed change represent a reduction in X
X commitment or process(es) described or (LBDCR (LBDCR established in the approved QA Program?
201 6-2016-03) 01)
Basis for Answer:
LBDCR 2016-03 The senior vice responsibte for nuclear operations is being eliminated as this position is combined with the chief nuclear officer, the highest level nuclear executive. This executive is nowresponsible forthe EN-QV-1 04 revision 4.3
ATTACHMENT 93 10 CFR 50.54(a) QAPM CHANGE EvALuATIoN FORM Page 2 of 6 Entergy OAPM Rev 29 Change No. 2 LBDCR 2016-01 & LBDCR 201 6-03 YES NO N/A impmentation Of all activities associated with the safe and reliable operation of the Entergys nuclear fleet including engineering services, nuclear safety, operations support, and corporate nuclear security.
The positions for chief operating officers will report directly to the highest level nuclear executive.
This change is not a reduction in commitment. The change is an enhancement to improve fleet organizational alignment and maintains adequate independence between the performing and verifying activities as allowed by 1 OCFR5O.54(a)(3) iii.
The changes identified in this evaluation are related to organizational responsibilities only and do not eliminate any commitments as agreed to through the Entergy fleet common QAPM.
This review ensures continued compliance with IOCFR5O Appendix B, NUREG-0800 and 1 OCFR5O.54(a)(3) commitments as recently accepted by the NRC via SER Approval for QAPM revisions 24 & 25, dated August 8, 2014.
3.
If item 2 above is YES, does the proposed change include the basis to conclude that the revised program incorporating the change X
continues to meet the criteria of I OCFR5O, (LBDCR Appendix B and other previously accepted USAR 201 6-01 commitments?
& 03)
Basis for Answer:
4.
Is the proposed change a change to a QA standard approved by the NRC which is more X
recent than the QA standard currently (LBDCR established in the Program?
2016-01
& 03)
Basis for Answer:
The changes identified in this evaluation are related to organizational responsibilities only and do not eliminate any commitments as agreed to through the Entergy_fleet_common_QAPM.
EN-QV-1 04 revision 4.3
ArrAcHMENT 9.3 1 0 CFR 50.54(a) QAPM CHANGE EvALuATIoN FORM Page 3 of 6 Entergy QAPM Rev 29 Change No 2 LBDCR 2016-01 & LBDCR 207 6-03 YES NON/A 5.
the proposed change a change involving the use of generic organizational position titles that clearly denote the position function, X
X supplemented as necessary by descriptive text, (LBDCR (LBDCR rather than specific titles?
201 6-2016-03) 01)
Basis for Answer:
These generic position titles remain in lower case in keeping with QAPM format and 10CFR5O.54 (a) (3) iii that allows the use of generic organizational position titles that clearly denote the position function, supplemented as necessary by descriptive text, rather than specific titles.
6.
Is the proposed change a change involving the use of generic organizational charts to indicate functional relationships, authorities, and X
responsibilities, or alternately, the use of (LBDCR descriptive text?
201 601
& 03)
Basis for Answer:
The Entergy QAPM does not use organizational charts to indicate functional relationships, authorities, or responsibilities.
7.
Is the proposed changean elimination of Quality Assurance Program information that duplicates language in Quality Assurance Regulatory X
Guides and Quality Assurance Standards to (LBDCR which EN is commiffed?
201 6-01
& 03)
Basis for Answer:
These changes does not eliminate a quality assurance standard to which the QAPM commits as denoted in Table 1 as the previously committed responsibilities remain unchanged.
8.
Doestheproposedchangecontinuetoensure that persons and organizations performing Quality Assurance functions continue to have the X
requisite authority and organizational freedom, (LBDCR including sufficient independence from cost and 201 6-01 schedule when opposed to safety
& 03) considerations?
EN-QV-1 04 revision 4.3
ATTAcHMENT 9 3 10 CFR 50 54(a) QAPM CHANGE EVALUATION FORM Page 4 of 6 Entergy QAPM Rev 29. Change No 2
LBDCR 201601 & LBDCR 201603 YES NO N/A Basis for Answer:
These generic position titles remain in lower case in keeping with QAPM format and 1 OCFR5O.54(a)(3)
(iii) that allows The use of generic organizational position titles that clearly denote the position function, supplemented as necessary by descriptive text, rather than specific titles. Additionally, 1 OCFR5O.54(a)(3) (vi) states Organizational revisions that 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. This change has no impact on the organizations performing quality assurance as they continue to have organizational freedom, including sufficient independence from cost and schedule when opposed to safety considerations as described in section A.2.b of the Entergy Quality Assurance Program Manual.
9.
Is a change to the QAPM required?
If YES, process change per EN-LI-i 1 3.
If NO, distribute as indicated below.
X oasis for Answer:
The QAPM does not currently reflect the proposed new organizational structure or the editorial corrections; thus, a revision is requited.
10CFR5O.54 REVIEW RESULTS
[ X ]
Change is editorial in accordance with 10CFR5O.54(a)(3) and thus, does not represent a reduction in commitment. The change can be implemented upon approval of parent change document. (LBDCR 201 6-01) t x I Does not represent a reduction of commitment, and can be implemented upon approval of parent change document. (LBDCR 201 6-03)
[ I Represents a reduction of commitment with prior NRC approval for another Licensee. The safety evaluation issued by the NRC has been evaluated and it directly applies to the changes being proposed for EN. The change can be implemented upon approval of patent change document.
EN-QV-1 04 revision 4.3
AUAcHMENT 93 Page 5 of 6 1 0 CFR 5O54(a) QAPM CHANGE EVALUATION FORM Entergy OAPM Rev _29_ Change No. _2_
[ I Represents a reduction of commitment; however, the change has sufficient basis to demonstrate continued compliance with Appendix B and USAR commitments.
Therefore, the proposed change should be submitted for NRC review/approval.
i: I Represents a reduction of commitment with insufficient basis to demonstrate continued compliance. Therefore, the activity should not be processed.
Ed Harris Manager, Corporate QA Approver Date EN-QV-104 revision 4.3 I
Date I 7/z/&0t L
ATTACHMENT 9.3 10 CFR 50.54(a) QAPM CHANGE EVALUATION FORM Page 6 of 6 Entergy QAPM Rev 39 Change No. 2 LBDCR 2016-01 & LBDCR 201 6-03 CHANGE DISPOSITION Approved for implementation ci Disapproved ci Approved for submittal to the NRC Approvedby/Date i
Vice President, Oversight Distribution: Original Attach to Parent Document; Copy Quality Assurance EN-QV-1 04 revision 4.3
q Enter Quality Assurance Program Manual Arkansas Nuclear One (Units I & 2)
Docket Nos. 50-313 & 50-368 License Nos. DPR-51 & NPF-6 Docket No. 72-13 DocketNo: 71-0341 Grand Gulf Nuclear Station Docket No. 50-416 License No. NPF-29 Docket No. 72-50 OocketNo: 71-0536 River Bend Station Docket No. 50-458 License No. NPF-47 Docket No. 72-49 DocketNo.: 71-0566 Waterlord 3 Steam Electric Station Docket No. 50-382 License No. NPF-38 Docket No. 72-75 Docket NoW: 71 -OO4 Palisades Nuclear Power Plant Docket No. 50-255 License No. DPR-20 Docket No. 72-07 Docket No.: 71 -0937 Indian Point I Nuclear Power Plant Docket No.50-003 License No. DPR-05 Docket No. 72-51 DocketNo.: 71-0240 Indian Point 2 Nuclear Power Plant Docket No. 50-247 License No. DPR-26 Docket No. 72-51 Docket No: 71-0240 Indian Point 3 Nuclear Power Plant Docket No. 50-286 License No. DPR-64 Docket No. 72-51 Docket No,: 71-0240 Pilgrim Nuclear Power Station Docket No. 50-293 License No. DPR-35 Docket No. 72-1044 Docket No: 71-0240 James A. FitzPatrick Nuclear Power Plant Docket No. 50-333 License No. DPR-59 Docket No. 72-12 Docket No.: 71 -0240 Big Rock Point Nuclear Plant-ISFSI Docket No. 50-155 License No. DPR-6 Docket No. 72-43 DocketNo: 71-0240 effective: July 30, 2016 Revision 30
QUALITY ASSURANCE PROGRAM MANUAL Entergy POLICY STATEMENT Entergy Operations, inc. (EQI) and Entergy Nuclear Operations, Inc. (ENQI) (hereafter referred to collectively as Entergy) shall maintain and operate nuclear plants in a manner that will ensure the health and safety of the public and workers. Facilities shalt be operated in compliance with the requirements of the Code of Federal Regulations, the applicable Nuclear Regulatory Commission (NRC) Facility Operating Licenses, and applicable laws and regulations of the state and local governments.
The Quality Assurance Program (QAP) described herein and associated implementing documents provide for control of activities that affect the quality of safety-related nuclear plant structures, systems, and components. The QAP is also applied to certain quality-related equipment and activities that are not safety-related, but support safe plant operations, or where other regulatory or industry guidance establishes program requirements.
The Quality Assurance Program Manual (QAPM) is the top-level policy document that establishes the manner in which quality is to be achieved and presents our overall philosophy regarding achievement and assurance of quality. Implementing documents assign mote detailed responsibilities and requirements and define the organizational interfaces involved in conducting activities within the scope of the QAPM. Compliance with the QAPM and implementing documents is mandatory for personnel directly or indirectly associated with implementation of the QAP.
Responsibility for developing, implementing, and verifying execution of the Quality Assurance Program is delegated to the chief nuclear officer (highest level nuclear executive) and authority for developing and verifying execution of the program to the executive responsible for oversight.
I Revision 30
QUALITY ASSURANCE PROGRAM MANUAL Entergy A.2. (continued) a.
Corporate Organization I
The Entergy Corporation chief executive officer (CEO) is responsible for overall corporate policy and provides executive direction and guidance for the corporation as welt as promulgates corporate policy through the Companys senior management staff. Responsibility for developing, implementing, and verifying execution of the Quality Assurance Program is delegated to the chief nuclear officer, the highest level nuclear executive, and authority for developing and verifying execution of the program to the executive responsible for nuclear oversight.
2.
The chief nuclear officer, the highest level nuclear executive officer, is responsible for providing top-level direction for the safe and reliable operation of Entergys nuclear sites. The highest level nuclear executive officer provides guidance with regards to company quality assurance policy. This position is responsible for providing engineering services, nuclear safety, and operations support. Supply chain and information technology are no longer a functional area exclusively within the nuclear organizational structure. However, the oversight and governance of these functional areas remain within the nuclear organization through this executive position that is responsible for nuclear operations. The off-site safety review committee reports to this executive.
3.
The following executives report to the highest level nuclear executive officer and provide governance and oversight in regards to implementing company quality assurance policy:
(a) The chief operating officers, the executives responsible for nucIet operations, are responsible for implementing quality assurance policies, goals, and objectives and the implementation of all activities associated with the safe and reliable operation of Entergys nuclear sites.
(b) The executive responsible for engineering and technical services are responsible for providing engineering services, including implementing quality assurance policies, goals, and objectives.
(C) The executives responsible for operations support are responsible for implementing quality assurance policies, goals, and objectives of Entergys corporate support activities.
(U) The executive responsible for project management is responsible for providing project management services, implementing major projects and modifications, and implementing quality assurance policies, goals, and objectives.
(e) The executive responsible for regulatory assurance is responsible for regulatory interfaces, licensing activities, corporate nuclear security, and implementing quality assurance policies, goals, and objectives.
2 Revision 30
QUALITY ASSURANCE PROGRAM MANUAL Entergy A.2.a3. (continued) to The executive responsible for production and outage services is responsible for providing outage services and implementing quality assurance policies, goals, and objectives.
(g) The executive responsible for oversight establishes the policies, goals, and objectives of the quality assurance policy and provides guidance and interpretation for implementing the company quality assurance policy and is responsible for governance and implementation of the quality assurance program in accordance with regulatory requirements. Independent oversight groups report to this executive.
(1) The following management positions report to this executive:
A management position that is responsible for nuclear oversight activities and is independent of production.
This position provides overall direction for the implementation of the quality assurance program.
I A management position that is responsible for oversight and governance of the QAPM. This manager has authority and responsibility for establishing, controlling, and verifying the implementation and adequacy of the quality assurance program as described in this QAPM including activities related to vendor quality. This position has the authority for Stop Work and responsibility to escalate matters directly to the highest level nuclear executive officer when needed.
b Site Organization The following site management positions describe the typical site QAPM functional responsibilities, which may be delegated to others as established in this document. These individuals may report through an additional layer of management but shall maintain sufficient authority and organizational freedom to implement the assigned responsibilities.
I.
An executive management position for each nuclear site reports through the applicable executive position responsible for each designated operating group. This position is responsible for overall plant nuclear safety at each site, and is responsible for establishing the policies, goals, and objectives and the implementation of the QAPM at the respective site.
3 Revision 30
ATTAcHMENT9.3 10 CFR 5054(a)QAPM CHANGE EvALuATIoN FORM Page 1 of 5 Entergy QAPM Rev 30 Change No. j.
LBDCR 207 5-01 1 OCFR5O.54(a) Evaluation Eliminate section K.3 from Table 1 of the Entergy Quality Assurance Program Manual Rev.29. This section currently reads as follows:
As an alternate to daily testing grout for compressive strength, for prepackaged shelf item, non-shrink grout, the grouts compressive strength tests may be performed once on each batch of non-shrink grout received, rather than each day grout is placed. This was previousty submitted to the Nuclear Regulatory Commission (NRC) via CNRO 201 5-00023 for approval and subsequently approved by the NRC via CNRI-201 6-00006.
NOTE
- The basis for the answers should be of sufficient depth and detail to support the conclusions reached and allow for independent review. Simply stating the change does not decrease the effectiveness without stating why is not acceptable.
Editorial corrections (i.e., spelling, punctuation, typographical or grammatical errors, and incorrect cross-references) are not considered changes and therefore, a Quality Assurance Program Regulatory Review is not required. All boxes should be checked N/A and proceed to signature page of the evaluation form.
9 Lf 1
Is this change an editorial change as defined in 10CFR5O.54(a)(3)? (If yes, provide basis, mark remaining questions N/A and state not a reduction X
in commitment) Proceed to approval page of attachment.
Basis for Answer:
Changes are not Editorial as aLlowed by 1 OCFR5O.54(a)(3).
2.
For any YES answer in the 10CFR5O.54(a) Screen or for the QA-initiated change, does the proposed change represent a reduction in commitment or X
process(es) described or established in the approved QA Program?
Basis for Answer:
Elimination of this requirement reduces the commitment as established in the consolidated Entergy Quality Assurance Program Manual as approved by the NRC via Safety Evaluation Report dated November 6, 1998. This SER approved the consolidated Quality Assurance programs for the Entergy fleet consisting of Arkansas Nuclear One (ANO), Grand Gulf Nuclear Station j
EN-QV-104 revision 4.3
ATTACHMENT9.3 10 CFR 50.54(a) QAPM CHANGE EvALUATIoN FoRM Page 2 of 5 Entergy QAPM Rev Change No.
LBDCR 201 5-01 YES NO N/A Waterford 3 (WF3) quality assurance programs. During this consolidation of QA Programs, Entergy adopted Standard Review Plan (SRP) 1L3 as the basis for the standard Quality Assurance Program. Included in the initial submittal Entergy committed to, as a clarification as noted in Table 1, 1(3, to perform compressive strength testing on prepackaged shelf, non-shrink grout on each batch received, rather than each day grout is placed.
Since this requirement was adopted during the consolidation of the Entergy QA Programs for ANO, GGNS, RBS, and WF3, and approved by the NRC via the Safety Evaluation Report dated November 6, 1998, the elimination of the requirement is considered a reduction of commitment as defined by 1 OCFR5O.54(a)4.
3.
If item 2 above is YES, does the proposed change include the basis to conclude that the revised program incorporating the change continues to meet X
the criteria of 1 OCFR5O, Appendix B and other previously accepted USAR commitments?
Basis for Answer:
This proposed change was submitted to the Nuclear Regulatory Commission (NRC) on November 6, 2015 via I
CNRQ-201 5-00023. The NRC approved the request on September 13, 2016 via CNRI-2016-00006. However, the NRC required additional information during their evaluation and the proposed request to eliminate the entire section in Table 1, K.3 was revised to add additional information in lieu of the complete elimination of this section. The following clarification was approved and will be included in revision 31 to the Entergy QAPM:
In accordance with ASME QA92-003 (ASME NQA-1 Interpretations), testing of non-shrink grout does not fall under the jurisdiction of N45.2.5 Table B; but the designer is responsible for identifying necessary testing and frequency requirements.
4.
Is the proposed change a change to a CA standard approved by the NRC which is more recent than the X
QAstandard currentlyestabhshed ipçfrpram?
EN-QV-1 04 revision 4.3
Page 3 of 5 Entergy QAPM Rev Change No.
LBDCR 201 5-01 NO N/A Basis for Answer:
This review ensures continued compliance wIth 10CFR5O Appendix B, NUREG-0800 as recently accepted by the NRC via SEA Approval for QAPM revisions 24 & 25, dated August 8, 2014.
5.
Is the proposed change a change involving the use of generic organizational position titles that clearly denote the position function, supplemented as X
necessary by descriptive text, rather than specific titles?
Basis for Answer:
This revision does not alter any reporting relationship or affect the authority, independence, or management reporting levels previously established for organizations performing quality assurance functions as described in the QAPM.
6.
Is the proposed change a change involving the use of generic organizational charts to indicate functional relationships, authorities, and responsibilities, or X
alternately, the use of descriptive text?
Basis for Answer:
The Entergy QAPM does not use organizational charts to indicate functional relationships, authorities, or responsibilities.
7.
Is the proposed change an elimination of Quality Assurance Program information that duplicates language in Quality Assurance Regulatory Guides X
and Quality Assurance Standards to which EN is committed?
Basis for Answer:
These changes does not eliminate a quality assurance standard to which the QAPM commits as denoted in Table 1 as the previously committed responsibilities remain unchanged.
EN-QV-1 04 revision 4.3 AUAcHMENT 9.3 1 0 CFR 50.54(a) QAPM CHANGE EVALUATION FORM
AUAcHMENT 9.3 1 0 CFR 50.54(a) QAPM CHANGE EVALUATION FORM Page 4 of 5 Entergy QAPM Rev
- 30. Change No. 1 LBDCR 2015-01 YES NO N/A 8.
Does the proposed change continue to ensure that persons and organizations performing Quality Assurance functions continue to have the requisite X
authority and organizational freedom, including sufficient independence from cost and schedule when opposed to safety considerations?
Basis for Answer:
This revision does not alter any reporting relationship or affect the authority, independence, or management reporting levels previously established for organizations performing quality assurance functions as described in the QAPM.
9 Is a change tothe QAPM required?
If YES, process change per EN-LI-i 1 3.
If NO, distribute as indicated below.
x Basis for Answer:
The QAPM does not currently reflect the approved clarification as approved by the NRC via CNRI-201 6-00006. This will be incorporated in QAPM Rev. 31.
10CFR5O.54 REVIEW RESULTS
[ ]
Change is editorial in accordance with IOCFR5O.54(a)(3) and thus, does not represent a reduction in commitment. The change can be implemented upon approval of parent change document.
[ I Does not represent a reduction of commitment, and can be implemented upon approval of parent change document.
[ X ]
Represents a reduction of commitment with prior NRC approval. The safety evaluation issued by the NRC has been evaluated and it directly applies to the changes being proposed for EN. The change can be implemented upon approval of parent change document. (Reference CNRI-2016-00006)
[ ]
Represents a reduction of commitment; however, the change has sufficient basis to demonstrate continued compliance with Appendix B and USAR commitments.
Therefore, the proposed change should be submitted for NRC review/approval.
[ I Represents a reduction of commitment with insufficient basis to demonstrate continued compliance. Therefore, the activity should not be processed.
N-QV-1O4 revision 4.3
ATTAcHMENT 93 10 CFR 50.54(a) QAPM CHANGE EvALuATIoN FORM Page 5 of 5 Entergy QAPM Rev 30 Change No. _i LBOCR 2075-Of Normanmt/
Corporate Qu1ty surance epartment Preparer Date EU Harris I,l#ø?,/2Dt Manager, Corporate QA Approver Date CHANGE DisPosiTioN Approved for implementation LI Disapproved EJ Approved for submittal to the NRC Approved by/Date:
..i to/ t; Vice President, Oversight Distribution: Original Attach to Parent Document; Copy Quality Assurance EN-QV-1 04 revision 4.3
ATTAcHMENT 9.3 1 0 CFR 5054(a) QAPM CHANGE EvALuATIoN FORM Page 1 of 5 Entergy QAPM Rev _30_ Change No.
2 LBDCR 201 6-04 1 OCFR5O.54(a) Evaluation The Senior Vice President, Engineering & Technical Services position is being added to the nuclear organization, reporting to the Chief Nuclear Officer. The following existing positions will report to the Senior Vice President, Engineering & Technical Services:
Vice President, Engineering & Technical Services Vice President, Major Fleet Projects Director, Nuclear Fuels The Senior Vice President, Nuclear Support Services position is being added to the nuclear organization, reporting to the Chief Nuclear Officer with the Vice President, Nuclear Sustainability Plan reporting to this position.
NOTE - The basis for the answers should be of sufficient depth and detail to support the conclusions reached and allow for independent review. Simply stating the change does not decrease the effectiveness without stating why is not acceptable.
Editorial corrections (i.e., spelling, punctuation, typographical or grammatical errors, and incorrect cross-references) are not considered changes and therefore, a Quality Assurance Program Regulatory Review is not required. All boxes should be checked N/A and proceed to signature page of the evaluation form.
YESfNO N/A 1.
Is this change an editorial change as defined in 1 OCFR5O.54(a)(3)? (If yes, provide basis, mark remaining questions N/A and state not a reduction X
in commitment) Proceed to approval page of attachment.
Basis for Answer:
Responsibilities are being added to the executive responsible for engineering & technical services to include project management services and implementation of major projects and modifications. This position reports directly to the highest level nuclear executive (chief nuclear officer). No QAPM responsibilities were eliminated with this chanqe.
2.
For any YES answer in the YOCFR5O.54(a) Screen or for the QA-initiated change, does the proposed change represent a reduction in commitment or process(es) described or established in the approved X
QA Program?
Basis for Answer:
or EN-QV-104 revision 4.3
ArrAcHMENT 9.3 10 CFR 50.54(a) QAPM CHANGE EVALUATION FORM Page 2 of 5 Entergy QAPM Rev 3Q Change No 2
LBDCR 2016-04 z::zz:z NO affect the authority, independence, or management reporting levels previously established for organizations performing quality assurance functions as described in the QAPM.
The generic position titles remain in tower case in keeping with QAPM format and 10CFR5O.54(a)(3) (iii) that allows The use of generic organizational position titles that clearly denote the position function, supplemented as necessary by descriptive text, rather than specific titles.
alf item2aboveisYES,doesthe proposed changel include the basis to conclude that the revised program incorporating the change continues to meet the criteria of 1 OCFR5O, Appendix B and other previously accepted USAR commitments?
Basis for Answer:
4.
Is the proposed change a change to a QA standard approved by the NRC which is more recent than the X
QA standard currently established in the Program?
Basis for Answer:
The changes identified in this evaluation are related to organizational responsibilities only and do not eliminate any commitments as agreed to through the Entergy fleet common QAPM.
This review ensures continued compliance with
. 10CFR5O Appendix B, NUREG-0800 as recently accepted by the NRC via SER Approval for QAPM revisions 24 & 25, dated August 8, 2014.
5.
Is the proposed change a change involving the use of generic organizational position titles that clearly denote the position function, supplemented as X
necessary by descriptive text, rather than specific titles?
Basis for Answer:
These generic position titles remain in lower case in keeping with QAPM format and 1 OCFR5O.54 (a) (3) iii EN-QV-104 revision 4.3
AUAcHMENT 9.3 1 0 CFR 50.54(a) OAPM CHANGE EVALUATION FORM Page 3 of 5 Entergy QAPM Rev ChangeNo 2 LBDCR 2016-04 YES NO N/A titles that clearly denote the position function, supplemented as necessary by descriptive text, rather than specific titles.
6.
Is the proposed change a change involving the use of generic organizational charts to indicate functional relationships, authorities, and responsibilities, or X
alternately, the use of descriptive text?
Basis for Answer:
The Entergy QAPM does not use organizational charts to indicate functional relationships, authorities, or responsibilities.
7.
Is the proposed change an elimination of Quality Assurance Program information that duplicates language in Quality Assurance Regulatory Guides X
and Quality Assurance Standards to which EN is committed?
Basis for Answer:
This change does not eliminate a quality assurance standard to which the QAPM commits as denoted in Table 1 as the previously committed responsibilities remain unchanged.
8.
Does the proposed change continue to ensure that persons and organizations performing Quality Assurance functions continue to have the requisite X
authority and organizational freedom, including sufficient independence from cost and schedule when opposed to safety considerations?
Basis for Answer:
These generic position titles remain in lower case in keeping with QAPM format and IOCFR5O.54(a)(3) (iii) that allows The use of genetic organizational position titles that clearly denote the position function, supplemented as necessary by descriptive text, rather than specific titles. Additionally, 1 OCFR5O.54(a)(3) (vi) states Organizational revisions that ensure that persons and organizations performing quality assurance functions continue to have the requisite authority and organizational freedom, including sufficient EN-QV-104 revision 4.3
I 0 CFR 5O54(a) QAPM CHANGE EVALUATION FORM 10CFR5O.54 REVIEW RESULTS
[ I Change is editorial in accordance with 1 OCFR5O.54(a)(3) and thus, does not represent a reduction in commitment. The change can be implemented upon approval of parent change document.
[ X ]
Does not represent a reduction of commitment, and can be implemented upon approval of parent change document.
[ ]
Represents a reduction of commitment with prior NRC approval. The safety evaluation issued by the NRC has been evaluated and it directly applies to the changes being proposed for EN. The change can be implemented upon approval of parent change document.
[ I Represents a reduction of commitment; however, the change has sufficient basis to demonstrate continued compliance with Appendix B and USAR commitments.
Therefore, the proposed change should be submitted for NRC review/approval.
[ I Represents a reduction of commitment with insufficient basis to demonstrate continued compliance. Therefore, the activity should not be processed.
Date EçJ i/oJ,/o it Manager, Corporate QA pprover Dath EN-QV-1 04 revision 4.3 AUAcHMENT 9.3 Page 4 of 5 Entergy QAPM Rev Change No.
2 LBDCR 2016-04 YES NON/A safety considerations. This change has no impact on the organizations performing quality assurance as they continue to have organizational freedom, including sufficient independence from cost and schedule when opposed to safety considerations as described in section A.2. a and A.2.b of the Entergy Quality Assurance Program Manual.
9.
15 a changetothe QAPM required?
If YES, process change per EN-Ll-113.
If NO, distribute as indicated below.
x Basis for Answer:
The QAPM does not currently reflect the proposed new organizational responsibilities; thus, a revision is required. This will be incorporated into QAPM Rev. 31.
I //2/2,j
ATTAcHMENT 9.3 1 0 CFR 50.54(a) QAPM CHANGE EVALUATION FORM Page 5 of 5 Entergy QAPM Rev,3O. Change No.
2 LBDCR 201604 CHANGE DISPOSITION Approved for implementation U Disapproved U Approved for submittal to the NRC Approved by/Date:,
ice President, Oversight Distribution: Original Attach to Parent Document; Copy Quality Assurance EN-QV-1 04 revision 4.3
QUALITY ASSURANCE PROGRAM MANUAL tEnte18y A.2. (continued) a.
Corporate Organization I.
The Entergy Corporation chief executive officer (CEO) is responsible for overalt corporate policy and provides executive direction and guidance for the corporation as well as promulgates corporate policy through the Companys senior management staff. Responsibility for developing, implementing, and verifying excution of the Quality Assurance Program is delegated to the chief nuclear officer, the highest level nuclear executive, and authority for developing and verifying execution of the program to the executive responsible for nuclear oversight.
2.
The chief nuclear officer, the highest level nuclear executive officer, is responsible for providing top1evel direction for the safe and reliable operation of Entergys nuclear sites. The highest level nuclear executive officer provides guidance with regards to company quality assurance policy. This position is responsible for providing engineering services, nuclear safety, and operations support. Supply chain and information technology are no longer a functional area exclusively within the nuclear organizational structure. However, the oversight and governance of these functional areas remain within the nuclear organization through this executive position that is responsible for nuclear operations. The off-site safety review committee reports to this executive.
- 3. The following executives report to the highest level nuclear executive officer and provide governance and oversight in regards to implementing company quality assurance policy:
(a) The chief operating officers, the executives responsible for nuclear operations, are responsible for implementing quality assurance policies, goals, and objectives and the implementation of all activities associated with the safe and reliable operation of Entergys nuclear sites.
(b) The executive responsible for engineering and technical services are-is responsible for providing engineering services, project management services and implementing major projects and modifications including implementing quality assurance policies, goals, and objectives.
4b)(c)
The executive responsible for nuclear support services is responsible for implementing quality assurance policies, goals, and objectives within assigned areas of responsibility.
()(d)
The executives responsible for operations support ace-is responsible for implementing quality assurance policies, goals, and objectives of Entergys corporate support activities.
,- -The executive responsible4orprnject management i responsible for providing-projeot-management-services-implementing major 2
Revision 31 Q
I QUALITY ASSURANCE PROGRAM MANUAL L-]3;1#ergy projects and-modifiations--and implementing-policies, goals1 and.objective&
A.2a3. (continued)
(e) The executive responsible for regulatory assurance is responsible for regulatory interfaces, licensing activities, corporate nuclear
security, and implementing quality assurance policies, goafs, and objectives.
(f) The executive responsible for production and outage services is responsible for providing outage services and implementing quality assurance policies, goals, and objectives.
(g) The executive responsible for oversight establishes the policies, goals, and objectives of the quality assurance policy and provides guidance and interpretation for implementing the company quality assurance policy and is responsible for governance and implementation of the quality assurance program in accordance with regulatory requirements. Independent oversight groups report to this executive.
(1) The following management positions report to this executive:
A management position that is responsible for nuclear oversight activities and is independent of production.
This position provides overall direction for the implementation of the quality assurance program.
A management position that is responsible for oversight and governance of the QAPM. This manager has authority and responsibility for establishing, controlling, and verifying the implementation and adequacy of the quality assurance program as described in this QAPM including activities related to vendor quality. This position has the authority for Stop Work and responsibility to escalate mailers directly to the highest level nuclear executive officer when needed.
b.
Site Organization The following site management positions describe the typical site QAPM functional responsibilities, which may be delegated to others as established in this document. These individuals may report through an additional layer of management but shall maintain sufficient authority and organizational freedom to implement the assigned responsibilities.
I.
An executive management position for each nuclear site reports through the applicabte executive position responsible for each designated operating group. This position is responsible for overall plant nuclear safety at each site, and is responsible for establishing 3
Revision 310 I
QUALITY ASSURANCE PROGRAM MANUAL I Enteigy Table I Regulatory Commitments K.
Regulatory Guide 1.94 Revision 1, dated April 1976 ClarificationlException 1.
ANSIN45.2.5 Section 2.5.2 2.
ANSI N45.2.5 Section 4.5 The last sentence requires that all items inspected with maintenance and test equipment, which is found to be out of calibration, shall be considered unacceptable. Entergy will comply with QAPM Section B.9.g as an alternate. QAPM Section B.9.g requires an evaluation to determine the validity of previous measurements.
When using ACl-3O572 and ACi-3O666, Entergy may apply the following requirements:
PLACII1 TEMPERATURES OF CONCRETE A. During hot weather concreting, ptacing temperatures of concrete will be limited to the following: 1) Concrete members less than 3 feet in least dimension will not exceed 90°F; 2) Concrete members from 3 feet to 6 feet in least dimension will not exceed 70°F; and 3)
Concrete members more than 6 feet in least dimension will have placing temperature as near 50°F as can be obtained by use of ice as necessary up to I 00 percent of adding mixing water; and by shading aggregate and sprinkling the coarse aggregate the day it is to be used.
Care will be taken so that no unmelted ice remains in the concrete at the end of the mixing period.
B. During cold weather concreting: In heating the water and aggregate, live steam to heat the fine and coarse aggregate shall not be used. The permissible range for concrete temperature shall be as follows: 1) Sections less than 3 feet in least dimensions 55°F to 75°F; and 2) Mass concrete 3 feet or more in least dimension 45°F to 65°F.
The mixing water and aggregate will be purchased as required. The materials will be free of ice, snow and frozen lumps before they enter the mixer.
In accordance with ASME QA92-003 (ASME NQA-1 Interpretations),
testing of non-shrink grout does not fall under the jurisdiction of N45.2.5 Table B; but the designer is responsible for identifying necessary testing and frequency requirements.Ps an alternatetu-u te8ting-grout for compressive strength, for prepackagedshelf item1 non-shrinkgrout, the grouts compressive strength tests-may be nRrformed-nnce on eh batch of ncn-shrink grout received, rather 3.
ANSI N45.2.5 Table B 4*
- h
- en cth day orout is-oiaced 40 Revision3l0
ATTACHMENT 93 QAPM CHANGE EVALUATION FORM Sheet 1 of 5 QAPM Rev 31_ Change No.
LBDCR NO: 207 7-03 OAPM Change Evaluation This change removes James A. Fitzpatrick (JAF) applicability from the Entergy Quality Assurance Program Manual due to the transfer of license to Exelon.
Editorial corrections (i.e., spelling, punctuation, typographical or grammatical erors, and incorrect cross-references) are not considered changes and therefore, a Quality Assurance Program Regulatory Review is not required. All boxes should be checked N/A and proceed to signature page of the evaluation form.
- YES, NO, or N/A 1.
Is this change aneditorial changeas defined in 7 0 CFR 50.54(a)(3) and 1 0 CFR 71.1 06? (If yes, provide basis) mark remaining questions N/A and state not a reduction in commitment) Proceed to approval page of attachment.
No Basis for Answer:
2.
For any YES answer in the 10 CFR 50.54(a) Screening or for the QA initiated change, does the proposed change represent a reduction in commitment or process(es) described or established in the approved QA Program?
Basis for Answer:
(This is a NIOS initiated change and a 10 CFR 50.54(a) Screening is not required.)
The change to the Entergy Quality Assurance Program Manual (QAPM) does not represent a reduction in commitment in that it separates James No A. Fitzpatrick (JAF) from the Entergy QAPM. The separation of JAF from the Entergy QAPM is due to the transfer of operating license to Exelon.
This transfer has been approved by the Nuclear Regulatory Commission (NRC) via Safety Evaluation Report (SER) dated March 1, 201 7, and available under Agency wide Documents Access and Management System (ADAMS) Accession No. ML 17041 Al 96.
This review ensures that the Entergy QAPM continues to comply with 10 CFR Part 50 Appendix B, Standard Review Plan 17.3, NUREG-0800, and 10 CFR 50.54(a)(3).
EN-QV-104 revision 5.3
ATTAcHMENT 9.3 QAPM CHANGE EVALUATION FORM Sheet 2 of 5 Rev 31 Change No.
LBDCR NO: 2017-03 a.
- Ifitem 2 above is YES, is theproposed change limited to the use of a quality assurance alternative or exception approved by the NRC Safety Evaluation Report (SER), for which the bases of the NRC approval are applicabte to Entergy?
If YES, explain how atlof the NRC approval bases from the SER are N/A incorporated or covered by the Entergy QA Program.
This exemption is notallowed under 1 0 CFR 71.1 06 and cannot be used to reduce commitments under part 71.
Basis for Answer:
4.
Is the proposed change a change to a QA standard approved by the NRC which is more recent than the QA standard currently established in the Program?
N/A Basis for Answer:
5.
Is the proposed change a change involving the use of generic organizational position titles that clearly denote the position function, supplemented as necessary by descriptive text, rather than specific N/A titles?
Basis for Answer:
6.
Is the proposed change a change involving the use of generic organizational charts to indicate functional relationships, authorities, and responsibilities, or alternately, the use of descriptive text?
N/A Basis for Answer:
7.
Is the proposed change an elimination of Quality Assurance Program information that duplicates language in Quality Assurance Regulatory Guides and Quality Assurance Standards to which EN is committed?
N/A
Basis for Answer:
8.
Does the proposed change continue to 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 N/A safety considerations?
Basis for Answer:
9.
Is a change to the QAPM required?
If YES, process change per EN-LI-i 1 3.
If NO, distribute as indicated below.
Yes Basis for Answer: This change will be incorporated in revision 32 of the
- Entergy QAPM.
EN-QV-104 revision 5.3
ATTACHMENT 93 QAPM CHANGE EvALUATIoN FORM Sheet 3 of 5
Rev 31_
Change No. J LBDCR NO:
QAPM CHANGE REVIEW RESULTS
[ I Change is editorial in accordance with 10 CFR 50.54(a)(3) and 1 0 CFR 71.106 thus, does not represent a reduction in commitment. The change can be implemented upon approval of parent change document. (Question 1 is YES)
[ X ]
Does not represent a reduction of commitment, and can be implemented upon approval of parent change document. (Questions 4, 5, 6, 7, 8 and 9 are YES or N/A)
[ ]
Represents a reduction of commitment with prior NRC approval. The safety evauation issued by the NRC has been evaluated and it directly applies to the changes being proposed for EN. The change can be implemented upon approval of parent change document. (Question 3 is YES)
[ I Represents a reduction of commitment; however, the change has sufficient basis to demonstrate continued compliance with Appendix B and USAR commitments.
Therefore, the proposed change should be submitted for NRC review/approval.
(Questions 2 is YES and Question 3 is NO)
[ ]
Represents a reduction of commitment with insufficient basis to demonstrate continued compliance. Therefore, the activity should not be processed.
Norman Ernst,/%,/
?
Preparer Date Ed Harris I c:::::2AEE Vz2-/1i.oI1 Manager, QA Corporate Date ENQV-1 04 revision 5.3
ATTACHMENT 9.3 QAPM CHANGE EvALuATIoN FoRM Sheet4of5 OAPM Rev 31 ChangeNo. _1..
LBDCR NO: 201 7-03 QA Site Supervisor Review: Not required for this change since there are no site LBDs affected by this change. JAF will transfer the operating license to Exelon and a 1 0 CFR 50.54(a) evaluation has been performed by Exelon to support this transfer.
Applicable Site QA Supervisor Reviews Require1 LlYes No (see attached sheets for documentation of reviews)
I ANO EYes LJN0
[iPEG LIYes EINo Elves 1No JAF LlYes UNd RBS UYes DNo PNPS UYes UNo J
WF3 flYes DNo VY IJYes__EIN0J Site Review Due Date:
N/A Site Review Input:
Record references below. If there are none state None.
ANO:
IPEC:
GGNS:
JAF:
RBS:
PNPS:
Site QA Supervisor acknowledges completion of reviews below ANO El GGNS LEI RBS LI WF3 :i IPEC LI JAF 0 PNPS U VY El Site QA Supervisor acknowledgement (print & sign) /date Site QA Supervisor N/A I
I Date EN-QV-1 04 revision 5.3
krmcHMENT 9 3 QAPM CHANGE EVALUATION FoRM Sheet 5 of 5 OAPM Rev 31 Change No.i LBDCR NO: 2017-03 CHANGE DisPosiTioN
. Approved for implementation U Disapproved U Approved for submittal to the NRC Approved by/Date:
L!/Z z/t
\\Yie President, (<Juclear Oversight Distribution: Original Attach to Parent Document; Copy Quality Assurance EN-QV-104 revision 5.3
Enter Quality Assurance Program Manual Arkansas Nuclear One (Units I & 2)
Docket Nos. 50-313 & 50-368 License Nos. DPR-51 & NPF-6 Docket No. 72-13 Docket No.: 71-0341 Grand Gulf Nuclear Station Docket No. 50-416 License No. NPF-29 Docket No. 72-50 DocketNo.: 71-0536 River Bend Station Docket No. 50-458 License No. NPF-47 Docket No. 72-49 Docket No.: 71-0566 Waterford 3 Steam Electric Station Docket No. 50-382 License No. NPF-38 Docket No. 72-75 Docket No.: 71-0604 Indian Point 1 Nuclear Power Plant Docket No.50-003 License No. DPR-05 Docket No. 72-51 Docket No.: 71-0240 Indian Point 2 Nuclear Power Plant Docket No. 50-247 License No. DPR-26 Docket No. 72-51 Docket No.: 71-0240 Indian Point 3 Nuclear Power Plant Docket No. 50-286 License No. DPR-64 Docket No. 72-51 Docket No.: 71-0240 Pilgrim Nuclear Power Station Docket No. 50-293 License No. DPR-35 Docket No. 72-1044 Docket No.: 71-0240 Palisades Nuclear Power Plant Docket No. 50-255 License No. DPR-20 Docket No. 72-07 DocketNo.: 71-0937 James A. FitzPatrick Docket No. 50 333 Liccncc No. DPR 50 DockctNo.72 12 DocketNo.: 71-0210 Big Rock Point Nuclear Plant-ISFSI Docket No. 50-155 License No. DPR-6 Docket No. 72-43 Docket No.: 71-0240 Effective: April 1, 2017 Revision 32
Attachment C CNRO2OI 7-00006 Revision 32
Enter Quality Assurance Program Manual Arkansas Nuclear One (Units I & 2)
Docket Nos. 50-313 & 50-368 License Nos. DPR-51 & NPF-6 Docket No. 72-13 Docket No.: 71-0341 Grand Gulf Nuclear Station Docket No. 50-416 License No. NPF-29 Docket No. 72-50 DocketNo.: 71-0536 River Bend Station Docket No. 50-458 License No. NPF-47 Docket No. 72-49 DocketNo.: 71-0566 Waterlord 3 Steam Electric Station Docket No. 50-382 License No. NPF-38 Docket No. 72-75 DocketNo.: 71-0604 Indian Point I Nuclear Power Plant Docket No.50-003 License No. DPR-05 Docket No. 72-51 DocketNo.: 71-0240 Indian Point 2 Nuclear Power Plant Docket No. 50-247 License No. DPR-26 Docket No. 72-51 DocketNo.: 71-0240
. Indian Point 3 Nuclear Power Plant Docket No. 50-286 License No. DPR-64 Docket No. 72-51 Docket No.: 71-0240 Pilgrim Nuclear Power Station Docket No. 50-293 License No. DPR-35 Docket No. 72-1044 Docket No.: 71-0240 Palisades Nuclear Power Plant Docket No. 50-255 License No. DPR-20 Docket No. 72-07 DocketNo.: 71-0937 James A. FitzPatrick Docket No. 50 333 Liccnc No. DPR 59 DockctNo.72 12 DocketNo.: 71-02lO r,I__4.
Big Rock Point Nuclear Plant-ISFSI Docket No. 50-155 License No. DPR-6 Docket No. 72-43 DocketNo.: 71-0240 Effective: April 1
, 2017 Revision 32
QUALITY ASSURANCE PROGRAM MANUAL Entergy POLICY STATEMENT Entergy Operations, Inc. (EOI) and Entergy Nuclear Operations, Inc. (ENOI) (hereafter referred to collectively as Entergy) shall maintain and operate nuclear plants in a manner that will ensure the health and safety of the public and workers. Facilities shall be operated in compliance with the requirements of the Code of Federal Regulations, the applicable Nuclear Regulatory Commission (NRC) Facility Operating Licenses, and applicable laws and regulations ofthe state and local governments.
The Quality Assurance Program (QAP) described herein and associated implementing documents provide for control of activities that affect the quality of safety-related nuclear plant structures, systems, and components. The QAP is also applied to certain quality-related equipment and activities that are not safety-related, but support safe plant operations, or where other regulatory or industry guidance establishes program requirements.
The Quality Assurance Program Manual (QAPM) is the top-level policy document that establishes the manner in which quality is to be achieved and presents our overall philosophy regarding achievement and assurance of quality. Implementing documents assign more detailed responsibilities and requirements and define the organizational interlaces involved in conducting activities within the scope of the QAPM. Compliance with the QAPM and implementing documents is mandatory for personnel directly or indirectly associated with implementation of the QAP.
Responsibility for developing, implementing, and verifying execution of the Quality Assurance Program is delegated to the chief nuclear officer (highest level nuclear executive) and authority for developing and verifying execution ofthe program to theexecutive responsible for oversight.
i Revision 32
QUALITYASSURANCE PROGRAM MANUAL Entergy TABLE OF CONTENTS SECTION PAGE A.
MANAGEMENT 1.
Methodology I
2.
Organization I
3.
Responsibility 5
4.
Authority 5
5.
Personnel Training and Qualification 5
6.
Corrective Action 6
7.
B.
PERFORMANCEIVERIFICATION 1.
Methodology 7
2.
Design Control 7
3.
Design Verification 8
4.
Procurement Control 9
5.
Procurement Verification 10 6.
Identification and Control of Items I I 7.
Handling, Storage, and Shipping 11 8.
TestControl 12 9.
Measuring and Test Equipment Control 12 I 0.
Inspection, Test, and Operating Status 13 11.
SpecialProcessControl 14 12.
Inspection 14 ii Revision 32
QUALITY ASSURANCE PROGRAM MANUAL Entergy TABLE OF CONTENTS SECTION PAGE B.
PERFORMANCENERIFICATION (continued)
I 3.
Corrective Action I 5 14.
Document Control 15 15.
Records 16 C.
AUDIT 1.
Methodology 17 2.
Performance 17 D.
INDEPENDENT SAFETY REVIEW 1.
Description 20 Table 1-Regulatory Commitments A.
Regulatory Guide I.8 Revision 1
, dated September 1 975 21 Personnel Qualification and Training B.
Regulatory Guide 1.30, dated August 1972 23 Quality Assurance Requirements for the Installation, Inspection, and Testing of Instrumentation and Electric Equipment C.
Regulatory Guide 1.33 Revision 2, dated February 1978 24 Quality Assurance Program Requirements D.
Regulatory Guide 1.37, dated March 1973 28 Quality Assurance Requirements for Cleaning of Fluid Systems and Associated Components of Water-Cooled Nuclear Power Plants E.
Regulatory Guide I.38 Revision 2, dated May I 977 29 Quality Assurance Requirements for Packaging, Shipping, Receiving, Storage and Handling of Items for Water-Cooled Nuclear Power Plants F.
Regulatory Guide 1.39 Revision 2, dated September 1977 34 Housekeeping Requirements for Water-Cooled Nuclear Power Plants iii Revision 32
QUALITYASSURANCE PROGRAM MANUAL Entergy TABLE OF CONTENTS SECTION PAGE Table 1-Regulatory Commitments (continued)
G.
Regulatory Guide 1.58 Revision 1, dated September 1980 35 Qualifications of Nuclear Power Plant lnpection, Examination, and Testing Personnel H.
Regulatory Guide 1.64 Revision 2, dated June 1976 36 Quality Assurance Requirements for the Design of Nuclear Power Plants I.
Regulatory Guide I.74 dated February 1 974 37 Quality Assurance Terms and Definitions J.
Regulatory Guide 1.88 Revision 2, dated October 1976 38 Collection, Storage and Maintenance of Nuclear Power Plant Quality Assurance Records K.
Regulatory Guide I.94 Revision I, dated April 1 976 40 Quality Assurance Requirements for Installation, Inspection and Testing of Structural Steel during the Construction Phase of Nuclear Power Plants L.
Regulatory Guide 1.116 Revision 0-R, dated June 1976 43 Quality Assurance Requirements for Installation, Inspection and Testing of Mechanical Equipment and Systems M.
Regulatory Guide I.1 23 Revision I
, dated July 1 977 44 Quality Assurance Requirements for control of Procurement of Items and Services for Nuclear Power Plants N.
Regulatory Guide 1.144 Revision 1, dated September 1980 47 Auditing of Quality Assurance Programs for Nuclear Power Plants 0.
Regulatory Guide 1.146 Revision 0, dated August 1980 50 Qualification of Quality Assurance Program Audit Personnel for Nuclear Power Plants iv Revision 32
QUALITY ASSURANCE PROGRAM MANUAL Entergy A.
MANAGEMENT Methodology a.
The Quality Assurance Program Manual (QAPM) provides a consolidated overview of the quality program controls which govern the operation and maintenance of Entergys (Entergy Operations, Inc.s (EOI) and Entergy Nuclear Operations, Inc. (ENOI)) quality related items and activities. The QAPM describes the quality assurance organizational structure, functional responsibilities, levels of authority, and interfaces.
b.
The requirements and commitments contained in the QAPM are mandatory and must be implemented, enforced, and adhered to by all individuals and organizations. Employees are encouraged to actively participate in the continued development of the QAPM as well as its implementation. Changes should be promptly communicated when identified.
c.
The QAPM applies to all activities associated with structures, systems, and components that are safety related or controlled by 10 CFR 72. The QAPM also applies to transportation packages controlled by 10 CFR 71.
The methods of implementation of the requirements of the QAPM are commensurate with the items or activitys importance to safety. The applicability ofthe requirements of the QAPM to other items and activities is determined on a case-by-case basis. The QAPM implements 10 CFR 50 Appendix B, 10 CFR 71 Subpart H, and 10 CFR 72 Subpart G.
d.
The QAPM is implemented through the use of approved procedures (e.g.,
policies, directives, procedures, instructions, or other documents) which provide written guidance for the control of quality related activities and provide for the development of documentation to provide objective evidence of compliance.
2.
Organization The organizational structure responsible for implementation of the QAPM is described below. The organizational structure consists of corporate functions and the nuclear facilities. The specific organization titles for the quality assurance functions described are identified in procedures. The authority to accomplish the quality assurance functions described is delegated to the incumbents staff as necessary to fulfill the identified responsibility.
I Revision 32
QUALITY ASSURANCE PROGRAM MANUAL Entergy A.2. (continued) a.
Corporate Organization 1
The Entergy Corporation chief executive officer (CEO) is responsible for overall corporate policy and provides executive direction and guidance for the corporation as well as promulgates corporate policy through the Companys senior management staff. Responsibility for developing, implementing, and verifying executiOn ofthe Quality Assurance Program is delegated to the chief nuclear officer, the highest level nuclear executive, and authority for developing and verifying execution of the program to the executive responsible for nuclear oversight.
2.
The chief nuclear officer, the highest level nuclear executive officer, is responsible for providing top-level direction for the safe and reliable operation of Entergys nuclear sites. The highest level nuclear executive officer provides guidance with regards to company quality assurance policy. This position is responsible for providing engineering services, nuclear safety, and operations support. Supply chain and information technology are no longer a functional area exclusively within the nuclear organizational structure. However, the oversight and governance ofthese functional areas remain within the nuclear organization through this executive position that is responsible for nuclear operations. The off-site safety review committee reports to this executive.
3.
The following executives report to the highest level nuclear executive officer and provide governance and oversight in regards to implementing company quality assurance policy:
(a) The chief operating officers, the executives responsible for nuclear operations, are responsible for implementing quality assurance policies, goals, and objectives and the implementation of all activities associated with the safe and reliable operation of Entergys nuclear sites.
(b) The executive responsible for engineering and technical services is responsible for providing engineering services, project management services and implementing major projects and modifications including implementing quality assurance policies, goals, and objectives.
(c) The executive responsible for nuclear support services is responsible for implementing quality assurance policies, goals, and objectives within assigned areas of responsibility.
(d) The executive responsible for operations support is responsible for implementing quality assurance policies, goals, and objectives of Entergys corporate support activities.
2 Revision 32
QUALITY ASSURANCE PROGRAM MANUAL Entergy A.2.a3. (continued)
(e) The executive responsible for regulatory assurance is responsible for regulatory interfaces, licensing activities, corporate nuclear security, and implementing quality assurance policies, goals, and objectives.
(f) The executive responsible for production and outage services is responsible for providing outage services and implementing quality assurance policies, goals, and objectives.
(g) The executive responsible for oversight establishes the policies, goals, and objectives ofthe quality assurance policy and provides guidance and interpretation for implementing the company quality assurance policy and is responsible for governance and implementation ofthe quality assurance program in accordance with regulatory requirements. Independent oversight groups report to this executive.
(1) The following management positions report to this executive:
A management position that is responsible for nuclear oversight activities and is independent of production.
This position provides overall direction for the implementation of the quality assurance program.
A management position that is responsible for oversight and governance of the QAPM. This manager has authority and responsibility for establishing, controlling, and verifying the implementation and adequacy of the quality assurance program as described in this QAPM including activities related to vendor quality. This position has the authority for Stop Work and responsibility to escalate matters directly to the highest level nuclear executive officer when needed.
b.
Site Organization The following site management positions describe the typical site QAPM functional responsibilities, which may be delegated to others as established in this document. These individuals may report through an additional layer of management but shall maintain sufficient authority and organizational freedom to implement the assigned responsibilities.
I An executive management position for each nuclear site reports through the applicable executive position responsible for each designated operating group. This position is responsible for overall plant nuclear safety at each site, and is responsible for establishing the policies, goals, and objectives and the implementation of the QAPM at the respective site.
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QUALITY ASSURANCE PROGRAM MANUAL Entergy A.2.b. (continued) 2.
The manager responsible for overall plant operations assures the safe, reliable, and efficient operation of the plant within the constraints of applicable regulatory requirements and the operating license.
Different aspects of these responsibilities may be fulfilled by separate managers. The onsite safety review committee reports to the manager responsible for plant operations.
3.
A manager responsible for engineering is responsible for the development and maintenance of engineering programs, plant design bases, policies, and procedures and for providing engineering services. Different aspects of these responsibilities (e.g., fuel design) may be fulfilled by separate managers.
4.
A manager responsible for regulatory and performance improvement is responsible for emergency planning, training, security, corrective action program, and records management. Different aspects of these responsibilities may be fulfilled by separate managers.
5.
The following site positions report directly to an executive position offsite:
(a)
A manager responsible for quality assurance who has overall authority and responsibility for establishing, controlling, and verifying the implementation and adequacy of the quality assurance program as described in this QAPM. This position has the authority and responsibility to escalate matters directly to the highest level nuclear executive officer when needed. This position reports to the executive responsible for nuclear oversight through the corporate management position responsible for nuclear oversight (offsite).
(b)
A manager responsible for materials, purchasing, and contracts is responsible for procurement, services, receipt, storage, and issue of materials, parts, and components. Different aspects of these responsibilities may be fulfilled by separate managers.
This site position reports to an executive (supply chain offsite) who has a functional interlace with the executive responsible for engineering and technical services.
C.
The on-site and off-site safety review committees independently review activities to provide additional assurance that the units are operated and maintained in accordance with the Operating License and applicable regulations that address nuclear safety.
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QUALITYASSURANCE PROGRAM MANUAL Entergy 3.
Responsibility a.
Entergy has the responsibility for the scope and implementation of an effective quality assurance program.
b.
Entergy may delegate all or part of the activities of planning, establishing, and implementing the quality assurance program to others, but retains the responsibility for the programs effectiveness.
c.
Entergy is responsible for ensuring that the applicable portion(s) of the quality assurance program is properly documented, approved, and implemented (people are trained and resources are available) before an activity within the scope of the QAPM is undertaken by Entergy or by others.
d.
Individual managers are to ensure that personnel working under their management cognizance are provided the necessary training and resources to accomplish their assigned tasks within the scope of the QAPM.
e.
Procedures that implement the QAPM are approved by the management responsible for the applicable quality function. These procedures are to reflect the QAPM and work is to be accomplished in accordance with them.
4.
Authority a.
When Entergy delegates responsibility for planning, establishing, or implementing any part of the overall QA program, sufficient authority to accomplish the assigned responsibilities is delegated.
b.
The manager responsible for quality assurance has the responsibility and the authority to stop unsatisfactory work and control further processing, delivery, installation, or use of non-conforming items or services. Cost and schedule considerations will not override safety considerations.
5.
Personnel Training and Qualification a.
Personnel assigned to implement elements of the quality assurance program are capable of performing their assigned tasks.
b.
Training programs are established and implemented to ensure that personnel achieve and maintain suitable proficiency.
c.
Personnel training and qualification records are maintained in accordance with procedures.
d.
Additional details concerning Personnel Training and Qualification may be found in the Regulatory Guides and associated Standards as committed to in Section A.Z and Table I (e.g., Regulatory Guides I.8, 1.58, and I.146).
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QUALITY ASSURANCE PROGRAM MANUAL Entergy 6.
Corrective Action a.
It is the responsibility of each individual to promptly identify and report conditions adverse to quality. Management at all levels encourages the identification of conditions that are adverse to quality.
b.
A corrective action program is established and implemented that includes prompt identification, documentation, and correction of conditions adverse to quality. The corrective action program for significant conditions adverse to quality shall require cause determination and a corrective action plan that precludes repetition.
c.
Specific responsibilities within the corrective action program may be delegated, but Entergy maintains responsibility for the programs effectiveness.
d.
Non-conforming items are properly controlled to prevent their inadvertent test, installation, or use. They are reviewed and either accepted, rejected, repaired, or reworked.
e.
Reports of conditions that are adverse to quality are analyzed to identify trends in quality performance. Significant conditions adverse to quality and significant trends are reported to the appropriate level of management.
f.
Additional details concerning corrective action activities may be found in the Regulatory Guides and associated Standards as committed to in Section AZ and Table I (e.g., Regulatory Guide 1.33).
7.
Except where alternatives are identified, Entergy complies with the QA guidance documents listed on Table I If the guidance in one of these documents is in conflict with the QAPM, the guidance provided in the QAPM is the controlling guidance. Additionally, the following clarifications apply to all guidance documents listed in Table I:
I For modifications and nonroutine maintenance, guidance applicable to construction-like activities is applicable to comparable plant activities. Except that the inspection of modifications, repairs, rework, and replacements shall be in accordance with the original design and inspection requirements or a documented approved alternative.
2.
The definitions provided by Regulatory Guide I.74 and associated clarifications as described in Table 1 apply wherever the defined term is used in the QAPM and associated guidance documents.
3.
Clarification to a guidance document applies wherever the guidance document is invoked.
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QUALITY ASSURANCE PROGRAM MANUAL Entergy A.7 (continued) 4.
In each ofthe ANSI standards, other documents (e.g., other standards, codes, regulations, tables, or appendices) are referenced or described. These other documents are only quality assurance program requirements if explicitly committed to in the QAPM.
If not explicitly committed to, these documents are not
considered as quality assuranc&program requirements, although they may be used as guidance.
5.
Guidance applicable to safety related items and activities is applicable to comparable items and activities controlled by 10 CFR 72 and transportation packages controlled by I 0 CFR 71.
b.
The NRC is to be notified of QAPM changes in accordance with 10 CFR 50.54(a)(3) or 10 CFR 50.54(a)(4).
B.
PERFORMANCEIVERIFICATION 1.
Methodology a.
Personnel performing work activities such as design, engineering, procurement, manufacturing, construction, installation, startup, maintenance, modification, operation, and decommissioning are responsible for achieving acceptable quality.
b.
Personnel performing verification activities are responsible for verifying the achievement of acceptable quality and are different personnel than those who performed the work.
c.
Work is accomplished and verified using instructions, procedures, or other appropriate means that are of a detail commensurate with the activitys complexity and importance to safety.
d.
Criteria that define acceptable quality are specified, and quality is verified against these criteria.
2.
Design Control a.
The design control program is established and implemented to assure that the activities associated with the design of systems, components, structures, and equipment and modifications thereto, are executed in a planned, controlled, and orderly manner.
b.
The program includes provisions to control design inputs, processes, outputs, changes, interfaces, records, and organizational interfaces.
c.
Design inputs (e.g., performance, regulatory, quality, and quality verification requirements) are to be correctly translated into design outputs (e.g., specifications, drawings, procedures, and instructions).
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QUALITY ASSURANCE PROGRAM MANUAL Entergy B.2 (continued) d.
The final design output is to relate to the design input in sufficient detail to permit verification.
e.
The design process is to ensure that items and activities are selected and independently verified consistent with their importance to safety to ensure
they are suitable for their intended application.
f.
Changes to final designs (including field changes and modifications) and dispositions of non-conforming items to either use-as-is or repair are to be subjected to design control measures commensurate with those applied to the original design and approved by the organization that performed the original design or a qualified designee.
g.
Interface controls (internal and external between participating design organizations and across technical disciplines) for the purpose of developing, reviewing, approving, releasing, distributing, and revising design inputs and outputs are defined in procedures.
h.
Design documentation and records, which provide evidence that the design and design verification process was performed in accordance with this program, shall be collected, stored, and maintained in accordance with documented procedures. This documentation includes final design documents, such as drawings and specifications, and revisions thereto and documentation which identifies the important steps, including sources of design inputs that support the final design.
i.
Additional details concerning design control activities may be found in the Regulatory Guides and associated Standards as committed to in Section A.7 and Table I (e.g., Regulatory Guide I.64).
3.
Design Verification a.
A program is established and implemented to verify the acceptability of design activities and documents for the design of items. The selection and incorporation of design inputs and design processes, outputs, and changes are verified.
b.
Verification methods include, but are not limited to, design reviews, alternative calculations, and qualification testing. The extent of this verification will be a function of the importance to safety of the item, the complexity of the design, the degree of standardization, the state of the art, and the similarity with previously proven designs. Standardized or previously proven designs will be reviewed for applicability prior to use.
c.
When a test program is used to verify the acceptability of a specific design feature, the test program is to demonstrate acceptable performance under conditions that simulate the most adverse design conditions that are expected to be encountered.
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QUALITY ASSURANCE PROGRAM MANUAL Entergy B.3 (continued) d.
Independent design verification is to be completed before design outputs are used by other organizations for design work and before they are used to support other activities such as procurement, manufacture, or construction. When this timing cannot be achieved, the unverified portion of the design is to be identified and controlled.
In all cases, the design verification is to be completed before relying on the item to perform its function.
e.
Individuals or groups responsible for design reviews or other verification activities shall be identified in procedures and their authority and responsibility shall be defined and controlled. Design verification shall be performed by any competent individuals or groups other than those who performed the original design but who may be from the same organization. The designers immediate supervisor may perform the design verification provided:
I the supervisor is the only technically qualified individual capable of performing the verification, 2.
the need is individually documented and approved in advance by the supervisors management, and 3.
. the frequency and effectiveness ofthe supervisors use as a design verifier are independently verified to guard against abuse.
f.
Design verification procedures are to be established and implemented to ensure that an appropriate verification method is used, the appropriate design parameters to be verified are chosen, the acceptance criteria are identified, the verification is satisfactorily accomplished, and the results are properly recorded.
g.
Additional details concerning design verification activities may be found in the Regulatory Guides and associated Standards as committed to in Section AZ and Table I (e.g., Regulatory Guide 1.64).
4.
Procurement Control a.
A program is established and implemented to ensure that purchased items and services are of acceptable quality.
b.
The program includes provisions for evaluating prospective suppliers and selecting only qualified suppliers.
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QUALITY ASSURANCE PROGRAM MANUAL Entergy B.4 (continued) c.
The program includes provisions for ensuring that qualified suppliers continue to provide acceptable products and services.
d.
The program includes provisions (e.g., source verification, receipt S
inspection, pre-installation and post-installation tests, and certificates of conformance) for accepting purchased items and services.
e.
Applicable technical, regulatory, administrative, and reporting requirements (e.g., specifications, codes, standards, tests, inspections, special processes, and I 0 CFR Part 21) are invoked for procurement of items and services.
f.
The program includes provisions for ensuring that documented evidence of an items conformance to procurement requirements is available at the site before the item is placed in service or used unless otherwise specified in procedures.
g.
The program includes provisions for ensuring that procurement, inspection, and test requirements have been satisfied before an item is placed in service or used unless otherwise specified in procedures.
h.
The procurement of components, including spare and replacement parts, is subject to quality and technical requirements suitable for their intended service.
i.
Appropriate controls for the selection, determination of suitability for intended use (critical characteristics), evaluation, receipt, and quality evaluation of commercial grade items are to be imposed to ensure that the items will perform satisfactorily in service.
j.
Additional details concerning procurement control may be found in the Regulatory Guides and associated Standards as committed to in Section AZ and Table I (e.g., Regulatory Guides 1.33 and 1.123).
5.
Procurement Verification a.
A program is established and implemented to verify the quality of purchased items and services at intervals and to a depth consistent with the items or services importance to safety, complexity, and quantity and the frequency of procurement.
b.
The program is executed in all phases of procurement. As necessary, this may require verification of activities of suppliers below the first tier.
10 Revision 32
QUALITY ASSURANCE PROGRAM MANUAL Entergy B.5 (continued)
C.
Additional details concerning procurement verification may be found in the Regulatory Guides and associated Standards as committed to in Section AZ and Table 1 (e.g., Regulatory Guides 1.123 and 1.144).
6.
Identification and Control of Items a.
A program is established and implemented to identify and control items to prevent the use of incorrect or defective items.
b.
Identification of each item is maintained throughout fabrication, erection, installation, and use so that the item can be traced to its documentation.
Traceability is maintained to an extent consistent with the items importance to safety.
c.
Additional details concerning identification and control of items may be found in the Regulatory Guides and associated Standards as committed to in Section A.7 and Table I (e.g., Regulatory Guide I.33).
7.
Handling, Storage, and Shipping a.
A program is established and implemented to control the handling, storage, shipping, cleaning, and preserving of items to ensure the items maintain acceptable quality.
b.
Special protective measures (e.g., containers, shock absorbers, accelerometers, inert gas atmospheres, specific moisture content levels, and temperature levels) are specified and provided when required to maintain acceptable quality.
c.
Specific procedures are developed and used for cleaning, handling, storage, packaging, shipping, and preserving items when required to maintain acceptable quality.
d.
Items are marked and labeled during packaging, shipping, handling, and storage to identify, maintain, and preserve the items integrity and indicate the need for special controls.
e.
Additional details concerning handling, storage, and shipping activities may be found in the Regulatory Guides and associated Standards as committed to in Section AZ and Table I (e.g., Regulatory Guide 1.38).
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QUALITY ASSURANCE PROGRAM MANUAL Entergy 8.
Test Control a.
A test control program is established and implemented to demonstrate that items will perform satisfactorily in service.
b.
Criteria are defined that specify when testing is required.
c.
The test contr program includes, as appropriate, proof tests before installation, pre-operational tests, post-maintenance tests, post-modification tests, and operational tests.
d.
Test procedures are developed that include:
1.
instructions and prerequisites to perform the test, 2.
use of proper test equipment, 3.
acceptance criteria, and 4.
mandatory inspections as required.
e.
Test results are evaluated to assure that test objectives and inspection requirements have been satisfied.
f.
Unacceptabletestresults shall be evaluated.
g.
Additional details concerning test control may be found in the Regulatory Guides and associated Standards as committed to in Section AZ and Table I (e.g., Regulatory Guide I.33).
9.
Measuring and Test Equipment Control a.
A program is established and implemented to control the calibration, maintenance, and use of measuring and test equipment. Measuring and test equipment does not include permanently installed operating equipment or test equipment used for preliminary checks where data obtained will not be used to determine acceptability or be the basis for design or engineering evaluation. Additionally, calibration and control measures are not required for rulers, tape measures, levels and other such devices if normal commercial manufacturing practices provide adequate accuracy.
b.
The types ofequipment covered by the program (e.g., instruments, tools, gauges, and reference and transfer standards) are defined in procedures.
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QUALITY ASSURANCE PROGRAM MANUAL Entergy B.9 (conUnued) c.
Measuring and test equipment is calibrated at specified intervals or immediately before use on the basis of the items required accuracy, intended use, frequency of use, and stability characteristics and other conditions affecting its performance.
d.
Measuring and test equipment is labeled, tagged, or otherwise controlled to indicate its calibration status and to ensure its traceability to calibration test data.
e.
Measuring and test equipment is calibrated against standards that have an accuracy of at least four times the required accuracy of the equipment being calibrated or, when this is not possible, have an accuracy that ensures the equipment being calibrated will be within the required tolerance.
f.
If nationally recognized standards exist, calibration standards are to be traceable to them. Except where calibration standards with the same accuracy as the instruments being calibrated are shown to be adequate for the requirements, calibration standards are to have a greater accuracy than the standards being calibrated.
g.
Measuring and test equipment found out of calibration is tagged or segregated. The acceptability shall be determined of items measured, inspected, or tested with an out-of-calibration device.
h.
Additional details concerning measuring and test equipment control may be found in the Regulatory Guides and associated Standards as committed to in Section AZ and Table I (e.g., Regulatory Guides 1.30, 1.33, 1.94, 1.116, and 1.123).
10.
Inspection, Test, and Operating Status a.
The status of required inspections and tests and the operating status of items is verified before release, fabrication, receipt, installation, test, and use, as applicable. This verification is to preclude inadvertent bypassing of inspections and tests and to prevent inadvertent operation of controlled equipment.
b.
The application and removal of inspection, test, and operating status indicators are controlled in accordance with procedures.
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QUALITY ASSURANCE PROGRAM MANUAL Entergy B.1O (continued) c.
Additional details concerning inspection, test, and operating status control may be found in the Regulatory Guides and associated Standards as committed to in Section AZ and Table 1 (e.g., Regulatory Guide 1.33).
I I.
Special Process Control a.
A program is established and implemented to ensure that special processes are properly controlled.
b.
The criteria that establish which processes are special are described in procedures. The following are special processes:
1.
- welding, 2.
heat-treating, 3.
NDE (Non-Destructive Examination),
4.
chemical cleaning, and 5.
unique fabricating or testing processes that require in-process controls.
c.
Special processes are accomplished by qualified personnel, using appropriate equipment, and procedures in accordance with applicable codes, standards, specifications, criteria, and other special requirements.
d.
Additional details concerning special process control may be found in the Regulatory Guides and associated Standards as committed to in Section A.f and Table I (e.g., Regulatory Guide I.33).
12.
Inspection a.
A program is established and implemented for inspections of activities in order to verify conformance to the documented instructions, procedures and drawings for accomplishing the activity. The inspection program may be implemented by or for the organization performing the activity to be inspected.
b.
Provisions to ensure inspection planning is properly accomplished are to be established. Planning activities are to identify the characteristics and activities to be inspected, the inspection techniques, the acceptance criteria, and the organization responsible for performing the inspection.
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QUALITY ASSURANCE PROGRAM MANUAL Entergy B.12 (continued) c.
Provisions to identify inspection hold points, beyond which work is not to proceed without the consent of the inspection organization, are to be defined.
d.
Inspection results areto be documented by the inspector and reviewed by qualified personnel.
e.
Unacceptable inspection results shall be evaluated and resolved in accordance with procedures.
f.
Inspections are performed by qualified personnel otherthan those who performed or directly supervised the work being inspected. While performing the inspection activity the inspectors functionally report to the associated manager responsible for quality assurance.
g.
Additional details concerning inspections may be found in the Regulatory Guides and associated Standards as committed to in Section AZ and Table I (e.g., Regulatory Guides 1.33 and 1.58).
13.
Corrective Action a.
Procedures shall provide for identification, evaluation, and resolution of conditions adverse to quality.
b.
Reworked, repaired, and replacement items are to be inspected and tested in accordance with the original inspection and test requirements or specified alternatives.
c.
Additional details concerning corrective action activities may be found in Section A.6 and the Regulatory Guides and associated Standards as committed to in Section A.Z and Table I (e.g., Regulatory Guide I.33).
14.
Document Control a.
A program is established and implemented to control the development, review, approval, issue, use, and revision of documents.
15 Revision 32
QUALITY ASSURANCE PROGRAM MANUAL Entergy B.14 (continued) b.
The scope of the document control program includes:
1 safety analysis report, 2.
design documents, 3.
Technical Specifications, 5.
procedures, manuals, and plans, 6.
corrective action documents, and 7.
other documents as defined in procedures.
c.
Revisions of controlled documents are reviewed for adequacy and approved for release by the same organization that originally reviewed and approved the documents or by a designated organization that is qualified and knowledgeable.
d.
Copies of controlled documents are distributed to and used by the person performing the activity.
e.
The distribution of new and revised controlled documents is in accordance with procedures. Superseded documents are controlled.
f.
Additional details concerning document control may be found in the Regulatory Guides and associated Standards as committed to in Section AZ and Table I (e.g., Regulatory Guide 1.33).
15.
Records a.
A program is established and implemented to ensure that sufficient records of items and activities (e.g., design, engineering, procurement, manufacturing, construction, inspection and test, installation, pre operation, startup, operations, maintenance, modification, decommissioning, and audits) are generated and maintained to reflect completed work.
b.
The program provides provisions for the administration, receipt, storage, preservation, safekeeping, retrieval, and disposition of records.
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QUALITY ASSURANCE PROGRAM MANUAL Entergy B.15 (continued) c.
The program includes provisions for the use of various record storage media to maintain QA records. Procedures are developed to implement the regulatory guidance associated with the media used. The NRC Generic Letter 88-18 Plant Record Storage on Optical Disk is implemented for optical disk media. The Regulatory Issue Summary 2000-18 Guidance on Managing QA Records in Electronic Media is implemented for electronic media.
d.
Additional details concerning record requirements may be found in the Regulatory Guides and associated Standards as committed to in Section A.7 and Table I (e.g., Regulatory Guide I.88).
C.
AUDIT 1.
Methodology a.
Personnel responsible for carrying out audits are maintained cognizant of day-to-day activities by the ongoing involvement in the quality assurance program requirements so that they can act in a management advisory function.
b.
Organizations performing audits are to be technically and performance oriented commensurate with the activity being reviewed.
c.
Personnel performing audits have no direct responsibilities in the area they are assessing.
d.
Audits are accomplished using instructions, procedures, or other appropriate means that are of a detail commensurate with the activitys complexity and importance to safety.
2.
Performance a.
A program of planned and periodic audits is established and implemented to confirm that activities affecting quality comply with the QAPM and that the QAPM has been implemented effectively. Audit frequencies will be implemented as required by the applicable Code of Federal Regulations, safety analysis report, and commitments by various correspondences to the NRC. Audits will be conducted at a frequency in accordance with either Section C2.a.1 or Section C.2.a.2 below. Audits of stand alone Independent Spent Fuel Storage Installations (ISFSI5) (e.g. those not sited with an operating nuclear power plant) may be conducted in accordance with Section C.2.a.4.
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QUALITY ASSURANCE PROGRAM MANUAL Entergy I
Audit frequencies will be determined in accordance with a performance based audit-scheduling program. The scheduling program, through an expert panel, uses assessment indicators to identify and schedule audits based on performance results and importance of the activity relative to safety. Potential audit subject area are periodically assessed against appropriate perlormanbe criteria. From these reviews a determination is made in regard to the depth, scope, and scheduling of specific audits. Functional areas important to safety are assessed annually (+/- 25%) to identify strengths and weaknesses (if applicable) to determine the level and focus of independent oversight activities for the upcoming year. The basis for the assessment shall include the results of audits and surveillance, NRC inspections, LERs, self-assessments, and applicable conditions reports (e.g., non-conformance and corrective action reports). Personnel changes, change/increase in functional area responsibilities, industry operating experience, and INPO evaluations will also be considered. Each area will be assigned a rating with a comparison to previous years. This assessment will be documented, reviewed, and approved by quality assurance management.
This document is considered a quality assurance record and will be available for NRC review. Audit subject areas of Section C.2.a.2 shall continue to be audited on the frequencies designated unless expert panel judgment, based on performance results, determines such an auditto be unnecessary. In such casesthe expert panel basis shall be documented.
2.
Audit schedules assure that the following areas are audited at the indicated frequencies, or more frequently as performance dictates.
a.
The conformance of each units operation to provisions contained within the Technical Specifications and applicable license conditions is audited at least once every 24 months.
b.
The performance, training, and qualifications of the entire staff are audited at least once every 24 months.
C.2 (continued) 18 Revision 32
QUALITY ASSURANCE PROGRAM MANUAL Entergy C.2 (continued) c.
The results of actions taken to correct deficiencies occurring in unit equipment, structure, systems, or method of operation that affect nuclear safety is audited at least once every 24 months.
d.
The performance of activities required by the QAPM to meet the criteria of 10 CFR 50, Appendix B is audited at least once every 24 months.
e.
The Offsite Dose Calculations Manual and Process Control Program and implementing procedures are audited at least once every 24 months.
f.
The radiological environmental monitoring program and the results thereof is audited at least once every 24 months.
g.
A fire protection and loss prevention program inspection and audit shall be performed using either off-site licensee personnel or an outside fire protection firm at least once every 24 months.
h.
The fire protection program and implementing procedures audit shall be performed at least once every 24 months.
i.
A fire protection and loss prevention program inspection and audit shall be performed using an outside fire consultant at least once every 36 months.
3.
A grace period of 90 days may be applied to the 24-month frequency for internal audits. For activities deferred in accordance with the 90-day grace period, the next performance due date will be based on their originally scheduled date.
4.
The audit schedule for stand alone ISFSIs may combine audits to cover the areas defined in section C.2.a.2 that are invoked by the ISFSI technical specifications.
b.
Audits shall provide an objective evaluation of quality related practices, procedures, instructions, activities, and items and a review of documents and records, as applicable.
c.
Audits shall be performed in accordance with approved written procedures or checklists. Items from previous audits shall be reviewed and reaudited, as appropriate. The checklists are used as guides to the auditor.
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QUALITY ASSURANCE PROGRAM MANUAL Entergy C2 (continued) d.
Scheduling and resource allocation are based on the status and safety importance of the activity or process being assessed.
e.
Scheduling is dynamic and resources are supplemented when the effectiveness ofthe quality assurance program is in doubt.
f.
Audit reports are written and distributed to the appropriate levels of management for review. Follow-up action, including re-look at deficient areas, is initiated as deemed appropriate.
g.
Implementation ofdelegated portions ofthe quality assurance program is assessed.
h.
Audits are conducted using predetermined acceptance criteria.
i.
Additional details concerning audits may be found in the Regulatory Guides and associated Standards as committed to in Section A.7 and Table 1 (e.g., Regulatory Guides 1.33 and 1.144).
0.
INDEPENDENT SAFETY REVIEW 1.
Description a.
Independent safety review is performed to meet the individual units commitment to NUREG-0737, Section l.B.1.2, Independent Safety Engineering Group, as described in the units safety analysis report.
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QUALITY ASSURANCE PROGRAM MANUAL Entergy Table I Regulatory Commitments A.
Regulatory Guide I.8 Revision
, dated September 1975 ClarificationlExcçption 1.
General Entergy is committed to Sections 1 4 ofANSl/ANS 3.1-1978 with following clarifications and exceptions.
Qualification requirements for personnel shall meet ANSI/ANS 3.1-I 978 except the following:
a.
The radiation protection manager shall meet or exceed the qualifications of Regulatory Guide 1.8, Revision 2, 1987.
b.
Managers required to hold an SRO license are specified in the applicable units Technical Specifications.
c.
Licensed Operators shall be qualified in accordance with the requirements of I 0 CFR 55.
Individuals filling positions who met the previous commitment at the time of implementation of this commitment can be considered to meet any more restrictive aspects of the requirements of this commitment for that position without further review and documentation.
2.
General The following qualifications may be considered equivalent to a bachelors degree:
a.
4 years of post secondary schooling in science or engineering, b.
4 years of applied experience at a nuclear facility in the area for which qualification is sought, c.
4 years of operational or technical experience/training in nuclear power, or d.
any combination of the above totaling 4 years.
Years of experience used to meet the education requirements as allowed by this exception shall not be used to also meet the experience requirements.
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QUALITY ASSURANCE PROGRAM MANUAL Entergy Table I Regulatory Commitments A.
Regulatory Guide I.8 (continued) 3.
ANS1/ANS 3.1 Individuals assigned to professional-technical comparable positions Section 4 shall have the authority and specified qualifications to accomplish the functional responsibilities of the position.
4.
ANS1/ANS 3.1 Individuals who do not possess the formal education and minimum Section 4.4.5 experience requirements for the manager responsible for quality assurance should not be eliminated automatically when other factors provide sufficient demonstration of their abilities. These other factors are evaluated on a case-by-case basis and approved and documented by senior management. As a minimum, the Special Requirements ofANSI/ANS 3.1-1993 Section 4.3.7 must be met if the manager responsible for Quality Assurance does not meet the requirements of section 4.4.5 of ANSI/ANS 3.1-1978.
5Property "ANSI code" (as page type) with input value "ANSI/ANS 3.1-1978.</br></br>5" contains invalid characters or is incomplete and therefore can cause unexpected results during a query or annotation process..
ANS1/ANS 3.1 Entergy will maintain a training program for the unit staff that meets ec ion the applicable regulations and either a) is accredited by the National Nuclear Accrediting Board (NNAB) or b) meets the standards of section 5 ofANSI/ANS 3.1-1978.
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QUALITY ASSURANCE PROGRAM MANUAL
. Entergy Table I Regulatory Commitments B.
Regulatory Guide 1.30, dated August 1972 I
ClarificationlException 1.
ANSI N45.2.4 ANSI N45.2.4 identifies various tests to be performed. The General applicability of these tests will be determined as discussed in QAPM Section B.8 and based upon the significance of change or modification.
2.
ANSI N45.2.4 Documented routine inspections and audits of the storage area may Section 3 be performed instead ofthe requirements ofthis Section.
3.
ANSI N45.2.4 In some cases, testing requirements may be met by post-Section 5.2 installation surveillance testing in lieu of a special post-installation test.
4.
ANSI N45.2.4 The last sentence ofthis section states: Items requiring calibration Section 6.2.1 shall be tagged or labeled on completion indicating date of calibration and identity of the person that performed the calibration.
Instead of requiring the tagging or labeling of all equipment this statement is changed to require the equipment to be suitably marked to indicate the date of the next required calibration and the identity of the person that performed the calibration.
23 Revision 32
QUALITY ASSURANCE PROGRAM MANUAL Entergy Table I Reg ulatory Corn rn itrnents C.
Regulatory Guide 1.33 Revision 2, dated February 1978 Clarification/Exception I.
Section C. I Entergy will provide procedures for the guides Appendix A activities as discussed. However, Entergy does not consider all activities listed to be safety-related (e.g., activities in 7.e).
2.
Section 0.4 This section establishes minimum 2-year audit frequency for all safety related functions and recommends audit frequencies specific to Corrective Action, Facility Operation, and Staff Performance, Training, and Qualifications. Entergy will perform audits at frequencies as discussed in QAPM Section C.2.a instead of this section.
3.
ANSI N18.7 Sentences 4 and 5 state, However, applicable sections of this Section 1 standard should be used as they apply to related activities. Activities included are: Design Changes, Purchasing, Fabricating... With regard to radioactive material transportation activities, Entergy will only implement the requirements associated with those activities conducted in accordance with the applicable NRC Quality Assurance Program Approval for Radioactive Material Packages.
4.
ANSI N18.7 The specific areas of experience described in this section are not Section 4.3.1 applicable to the on-site safety review committee butthe committee must be comprised of site operating or engineering supervisory personnel. Additionally, the off-site safety review committee need contain experience in only a majority of the areas.
5.
ANSI NI 8.7 The statement that no more than a minority of the quorum shall have Section 4.3.2.3 line responsibility for the operation of the plant is not applicable to the on-site safety review committee.
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QUALITY ASSURANCE PROGRAM MANUAL Entergy Table I Regulatory Commitments C.
Regulatory Guide 1.33 (continued)
Clarification/Exception 6.
ANSI N18.7 10 CFR 50.59 was revised through Federal Register Notice Section 1 9991 001 RI N31 50-AF94 eliminating the terms safety evaluation 4.3.4(1) & (2) and unreviewed safety question The term safety evaluation has been replaced with 10 CFR 50.59 evaluation. The term unreviewed safety question, as defined in the previous version of IC CFR 50.59 (a)(2), was replaced by criteria provided in 50.59(c)(2) to determine if a license amendment pursuant to 50.90 is required prior to implementing the change, test, or experiment.
7.
ANSI N18.7 Reviews associated with changes to the technical specifications will Section 4.3.4(2) be performed in accordance with Section 4.3.4(3) instead of this section.
8.
ANSI N18.7 Revision to proposed Technical Specification changes only requires Section 4.3.4(3) review in accordance with this section when the revision involves a significant change to the technical basis for the proposed change.
The independent review body discussed in this section is the on-site safety review committee. Voting members having a potential conflict of interest refrain from voting on documents under review.
9.
ANSI N18.7 In place ofthe requirements ofthis section, the on-site and off-site Section 4.3.4(4) safety review committees shall review facility operations to detect potential nuclear safety hazards and all reports made in accordance with I 0 CFR 50.73.
Jo.
ANSI N18.7 An example ofthe matters reviewed by the on-site safety review Section 4.3.4(5) committee in accordance with this section is a change to the Emergency Plan (except editorial changes).
I I.
ANSI NI 8.7 This section establishes minimum 2-year audit frequency for all safety Section 4.5 related functions. Entergy will perform audits atfrequencies as discussed in QAPM Section C.2.a instead of this section.
12.
ANSI N18.7 The independent review body discussed in this section is the off-site Section 4.5 safety review committee.
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QUALITY ASSURANCE PROGRAM MANUAL
- Entergy Table I Regulatory Commitments C.
Regulatory Guide I.33 (continued)
Clarification/Exception 13.
ANSI N18.7 Instead ofthe requirements ofthis section to have a summary Section 5.1 document, a method of cross-referencing these requirements to the implementing procedures will be maintained.
14.
ANSI N18.7 The person who holds a senior reactoroperators license for the Section 5.2.2 affected unit and approves a temporary change to a procedure is not required to be in charge of the shift.
15.
ANSI N18.7 In addition to the temporary procedure change process described for Section 5.2.2 changes which clearly do not change the intent of a procedure, temporary procedure changes which may change the intent of a procedure may be made following the process described in this section. Except that the person normally responsible for approving revisions to the procedure is the approval authority for the change.
16.
ANSI N18.Z Instead ofthe requirements ofthis section concerning non-Section 5.2.6 conforming conditions, non-conforming conditions will be evaluated and controlled in accordance with the corrective action program.
17.
ANSI N18.7 The requirementofthefifth paragraph ofthis section to have a log of Section 5.2.6 the status of temporary modifications is not applicable to temporary modifications for routine tasks installed in accordance with procedures. These procedures shall provide assurance that approvals are obtained, temporary modification activities are independently verified by an individual cognizant of the purpose and the effect of the temporary modification, and that activities are adequately documented to indicate the status of the temporary modification.
18.
ANSI N18.7 This section will be implemented by adding the words Where Section 5.2.7.1 practical in front ofthe first and fourth sentences of the fifth paragraph. For modifications where the requirements of the fourth sentence are not considered practical, a review in accordance with the provisions of 10 CFR 50.59 will be conducted.
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QUALITY ASSURANCE PROGRAM MANUAL
. Entergy Table I Regulatory Commitments C.
Regulatory Guide 1.33 (continued)
Clarification/Exception 19.
ANSI N18.7 In lieu ofa master surveillance schedule, the following requirement Section 5.2.8 shall be complied with: A surveillance testing schedule(s) shall be established reflecting the status of all in-plant surveillance tests and inspections 20.
ANSI N18.7 The requirements ofthe Physical Security Plan shall be implemented Section 52.9 in place of these general requirements.
21.
ANSI N18.7 Consistentwith ANSI N45.2.11 Section 72, minorchanges to Section documents, such as inconsequential editorial corrections, or changes 5.2.13.1 to commercial terms and conditions may not require that the revised document receive the same review and approval as the original documents.
22.
ANSI N18.7 Where marking, tagging, or physical separation ofthe non-conforming Section 5.2.14 item is not feasible, the non-conforming item may be controlled by the use of appropriate documentation.
23.
ANSI N18.7 Required procedure reviewsfollowing the occurrences discussed in Section 5.2.15 Section 5.215, paragraph 3, sentence 3, are determined and controlled in accordance with the QAPM Section A.6 instead of this section.
24.
ANSI N18.7 This section requires plant procedure review by an individual Section 5.2.15 knowledgeable in the area affected by the procedure no less frequently than every two years to determine if changes are necessary or desirable. Instead of this review, controls are in effect to ensure that procedures are reviewed for possible revision upon identification of new or revised source material potentially affecting the intent of procedures.
25.
ANSI N18.Z Instead ofthe requirements ofthis section, the format and content of Section 5.3.9 the emergency operating procedures follow the applicable NRC approved format for the specific unit.
26.
ANSI N18.7 Entergys NRC accepted Emergency Plan will be implemented in lieu Section 5.3.9.3 ofthe requirements in this section.
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QUALITY ASSURANCE PROGRAM MANUAL Entergy Table I Regulatory CommItments D.
Regulatory Guide 1.37, dated March 1973 ClarificationlException I.
General Instead of using the cleanliness level classification system of ANSI N452.1
, the required cleanliness for specific items and activities is addressed on a case-by-case basis. Cleanliness is maintained, consistent with the work being performed to prevent introduction of foreign material. As a minimum, cleanliness inspections are performed prior to system closure and such inspections are documented.
2.
Section C.3 The water quality for final flushes of fluid systems and associated components is at least equivalent to the quality of the operating system water, except for the oxygen and nitrogen content.
3.
Section C.4 As an alternate to the requirements of this section, contamination levels in expendable products may be based upon safe practices and industrial availability with documented engineering evaluations.
Contaminant levels are controlled such that subsequent removal by standard cleaning methods results in the achievement of final acceptable levels that are not detrimental to the materials.
4.
ANSI N45.2.1 Any nonhalogenated material may be used which is compatible with the Section 5 parent material not just plastic film.
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QUALITY ASSURANCE PROGRAM MANUAL Entergy Table I Reg ulatory Corn rn itrnents E.
Regulatory Guide I.38 Revision 2, dated May I 977 CIarification/Exception I.
ANSI N45.2.2 Storage of an item in a higher-level storage area meets the lower level Section 3.2 storage requirements.
2.
ANSI N45.2.2 As an alternate to the requirements in Section 3.2.1 items (4), (5), and Section 3.2 7, Section 3.2.2, Section 3.2.3 item (1), and Section 3.2.4 item (2), the storage atmosphere may be controlled such that it is free of harmful contaminants in concentration that could produce damage to the stored item and protecting weld end preparations and threads by controlling the manner in which the item is stored.
3.
ANSI N45.2.2 Cleated, sheathed boxes may be used up to 1000 lb. rather than 500 Section 3.7.1 lb. as specified in 3.7.1(1). Special qualification testing may be required for loads over 1000 lb.
4.
ANSI N45.2.2 Skids and runners will normally be fabricated from a minimum 2 X 4 Section 3.7.2 inch nominal lumber size and laid flat except where this is impractical because of the small dimensions of the container.
If forklift handling is required, minimum floor clearance for forklift tines will be provided.
5.
ANSI N45.2.2 Inspections of packages and/or preservative coatings are made Section 4.3.4 immediately prior to loading rather than after loading.
6.
ANSI N45.2.2 Warehouse personnel will normally visually scrutinize incoming Section 5.2.1 shipments for damage of the types listed in this section, this activity is not necessarily performed prior to unloading. Separate documentation of the shipping damage inspection is not necessary.
Release of the transport agent after unloading and the signing for receipt of the shipment provides adequate documentation of completion of the shipping damage inspection. Any non-conformances noted will be documented and dispositioned. Persons performing the visual scrutiny during unloading are not considered to be performing an inspection function as defined under Reg. Guide I.74; therefore, while they will be trained to perform this function, they may not be certified (N45.2.6) as an inspector.
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QUALITY ASSURANCE PROGRAM MANUAL
- Entergy Table I Regulatory Commitments E.
Regulatory Guide 1.38 (continued)
ClarificationlException 7.
ANSI N45.2.2 The second division of this subsection requires six additional Section 5.2.2 inspection activities if an item was not inspected or examined at the source. Entergy will consider that a source inspection has been conducted if the supplier of the item is required to comply with ANSI N45.2.2 for the purchased item and if the suppliers program has been audited and found acceptable in the area (i.e., the supplier performs a source inspection of his supplier or conducts a receipt inspection that includes, as applicable, the six additional items listed).
Instead of the requirement that receiving inspections be performed in an area equivalent to the level of storage required for the item, receiving inspections will be performed in a manner and in an environment which does not endanger the requisite quality of an item.
The receiving inspections location environmental controls may be less stringent than storage environmental requirements for that item; however, the short time spent in the less stringent receiving inspection area shall be of such duration that it will not adversely affect the item being received.
8.
ANSI N45.2.2 The Special Inspection procedure is not required to be attached to Section 5.2.3 the item or container but shall be readily available to inspection personnel.
9.
ANSI N45.2.2 Items which fall within the Level D classification ofthe standard will Section 6.2.1 be stored in an area which may be posted to limit access, but other positive controls such as fencing or guards may not be provided.
10.
ANSI N45.2.2 The sentence is replaced with the following: The use or storage of Section 6.2.4 food, drinks, and salt tablet dispensers in any storage area shall be controlled and shall be limited to designated areas where such use or storage is not deleterious to stored items.
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QUALITY ASSURANCE PROGRAM MANUAL Entergy Table I Regulatory Commitments E.
Regulatory Guide I.38 (continued)
ClarificationlException I I.
ANSI N452.2 The sentence is replaced with the following: Exterminators or other Section 6.2.5 appropriate measures shall be used to control animals to minimize possible contamination and mechanical damage to stored material.
If evidence of animal activity is detected, a survey or inspection will be utilized to determine the extent of the damage.
12.
ANSI N45.2.2 An alternate to the stated requirement is the following: Hazardous Section 6.3.3 chemicals, paints, solvents, and other materials of a like nature shall be stored in approved cabinets or containers which are not in close proximity to installed systems required for safe shutdown.
13.
ANSI N45.2.2 Care of items in storage shall be exercised in accordance with the Section 6.4.2 following: Types of components that could require maintenance while in storage shall be identified and evaluated for specific maintenance requirements. Maintenance activities 6.4.2 (6) through 6.4.2 (8) listed in this requirement shall be considered during this evaluation and any deviations shall be justified and documented.
14.
ANSI N45.2.2 The last sentence ofthis section is not applicable to the operations Section 6.5 phase.
15.
ANSI N45.2.2 Entergy will comply with this sections requirements with the Section 6.6 clarification that, for record purposes, only the access of personnel without key cards into indoor storage areas shall be recorded.
Unloading or pickup of material shall not be considered access, nor shall inspection by NRC or other regulatory agents, nor shall tours by nonlicensee employees who are accompanied by licensee employees.
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QUALITY ASSURANCE PROGRAM MANUAL Entergy Table I Regulatory Commitments E.
Regulatory Guide 1.38 (continued)
ClarificationlException 16.
ANSI N45.2.2 Re-rating hoisting equipment will be considered only when Section 7.3 necessary. Priorto performing any liftabovethe load rating, the equipment manufacturer must be contacted for his approval and direction. The manufacturer must be requested to supply a document granting approval for a limited number of lifts at the new rating and any restrictions involved, such as modifications to be made to the equipment and the test lift load. At all times, the codes governing re-rating of hoisting equipment must be observed.
17.
ANSI N45.2.2 During printing ofthe standard, a transposition occurred between Appendix (A-3) the last sentence ofA3.4.1(4) and A3.4.1(5). The correct Section A.3.4.1 requirements are: (4) However, preservatives for inaccessible inside surfaces of pumps, valves and pipe systems containing reactor coolant water shall be the water flushable type. (5) The name of the preservative used shall be indicated to facilitate touch up.
18.
ANSI N45.2.2 There may be cases involving large or complex shaped items for Appendix (A-3) which an inert or dry air purge is provided, rather than a static gas Section A.3.4.2 blanket, in order to provide adequate protection due to difficulty of providing a leak proof barrier. In these cases, a positive pressure purge flow may be utilized as an alternate to a Ieakproof barrier.
19.
ANSI N45.2.2 Instead ofthe requirement for non-metallic plugs and caps to be Appendix (A-3) brightly colored, non-metallic plugs and caps shall be an Section A.3.5.1 appropriately visible color.
20.
ANSI N45.2.2 This paragraph limits halogen and sulfur content of tape. The use Appendix (A-3) of tapes containing greater amounts of halogens than those Section A.3.5.2 identified will be allowed after appropriate evaluation; however, the quantities shall not be such that harmful concentrations could be leached or released by breakdown of the compounds under expected environmental conditions.
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QUALITYASSURANCE PROGRAM MANUAL Entergy Table I Reg ulatory Cornrn itrnents E.
Regulatory Guide 1.38 (continued)
çlarificationlException 21.
ANSI N45.2.2 In lieu ofA.3.7.1(3)and (4), Entergywill complywiththefollowing:
Appendix (A-3)
Fiberboard boxes shall be securely closed either with a water Section A.3.7.1 resistant adhesive applied to the entire area of contact between the flaps, or all seams and joints shall be sealed with not less than 2-inch wide, water resistant tape.
22.
ANSI N45.2.2 Instead of the requirement that container markings appear on a Appendix (A-3) minimum of two sides of the container, preferably on one side and Section A.3.9 one end, Entergy will comply with the following: Containers are adequately marked for storage, identification, and retrieval.
Multiple marking requirements are imposed, where necessary.
23.
ANSI N45.2.2, Instead of the requirement that container markings be no less than Appendix (A-3) 3/4 high, Entergy will comply with the following: Container Section A.3.9 markings are of a size which permits easy recognition.
24.
ANSI N45.2.2, Instead of the specific container marking requirements, Entergy will Appendix (A-3) comply with the following: The information required in container Section A.3.9 marking is evaluated on a case-by-case basis.
25.
ANSI N45.2.2 The last paragraph of A.3.9 could be interpreted as prohibiting any Appendix (A-3) direct marking on bare austenitic stainless steel and nickel alloy Section A.3.9 metal surfaces. As a alternate, paragraphs A.3.9.(1) and (2) may be used to control marking on the surface of austenitic stainless steels and nickel base alloys based on documented engineering evaluations. Contamination levels are controlled such that the material used for marking is not detrimental to the materials marked.
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QUALITY ASSURANCE PROGRAM MANUAL Entergy Table I Regulatory Commitments F.
Regulatory Guide 1.39 Revision 2, dated September 1977 Clarification/Exception 1.
ANSI N45.2.3 The ANSI five level zone designation system may not be utilized, but General the intent of the standard will be met for the areas of housekeeping, plant and personnel safety, and fire protection.
2.
ANSI N45.2.3 This section is not applicable.
Section 3.1 3.
ANSI N45.2.3 The Fire Protection Program shall be used in lieu of the general Section 3.2.3 requirements in this section.
4.
ANSI N45.2.3 The first paragraph is not applicable to the operations phase.
Section 3.3 5.
ANSI N45.2.3 This section is not applicable.
Section 3.4 6.
ANSI N45.2.3 Subparagraph (1) is not applicable to the operations phase; (2), (3),
Section 3.5 and (4) will be implemented.
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QUALITY ASSURANCE PROGRAM MANUAL Entergy Table I Regulatory Commitments G.
Regulatory Guide 1.58 Revision 1, dated September 1980 Clarification/Exception I.
General Entergy may choose not to apply the requirements of this guide to those personnel who are involved in day-to-day operations, surveillance, maintenance, and certain technical and support services whose qualifications are controlled by the Technical Specifications or other QAPM commitment requirements.
2.
General General certification of inspectors in accordance with this guide is approved by a manager responsible for quality.
3.
ANSI N45.2.6 Paragraph 4 requires that the standard be imposed on personnel Section 1.2 other than licensee employees; the applicability of this standard to suppliers will be documented and applied, as appropriate, in procurement documents for such suppliers.
4.
ANSI N45.2.6 The requirements of this standard do not apply to personnel using Section 1.2 later editions of ASNT contained within I OCFR5O.55a approved ASME editions or addenda.
5.
ANSI N45.2.6 This section requires, in part, that any person who has not Section 2.3 performed inspection, examination, or testing activities in his qualified area for a period of one year shall be re-evaluated. A 90-day grace period may be applied to this activity. For activities deferred in accordance with the 90-day grace period, the next performance due date will be based on their originally scheduled date.
6.
ANSI N45.2.6 This sections requirements are clarified with the stipulation that, Section 2.5 where no special physical characteristics are required, none will be specified. The converse is also true: if no special physical requirements are stipulated, none are considered necessary.
7.
ANSI N45.2.6 Entergy reserves the right to use personnel who do not meet these Section 3.5 experience requirements but have shown capability through training and testing or capability demonstration.
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QUALITY ASSURANCE PROGRAM MANUAL Entergy Table I Regulatory Commitments H.
Regulatory Guide 1.64 Revision 2, dated June 1976 ClarificationlException 1.
ANSI N45.2.11 Forthe documentation of inter-disciplinary design reviews, there must Section 5.2.4 be documented evidence of the acceptability of design documents, or portions thereof, prior to release (material, stress, physics, mechanical, electrical, concrete, etc.). Indication of the positive concurrence of those who determine the design acceptability relative to their respective disciplinary area of concern should be on the document or on a separate form traceable to the document. A document that indicates the reviewers comments need not be retained.
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QUALITYASSURANCE PROGRAM MANUAL Entergy Table I Regulatory Commitments Regulatory Guide 1.74, dated February 1974 ClarificationlException 1.
ANSI N452.1O, Definitions for Certificate ofConformance and Certificate of Section 2 Compliance will be exchanged based upon the guidance in ANSI N452.13 Section 10.2.
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QUALITY ASSURANCE PROGRAM MANUAL Entergy Table I Regulatory Commitments J.
Regulatory Guide L88 Revision 2, dated October 1976 Clarification/Exception I.
RG I.88 Entergy will meet the requirements of NFPA No. 232-1975, Section C Standards for the Protection of Records, as allowed by the RegulatoryGuide 1.88 1976 orANSI/ASME NQA-1-1983, Supplement 175-1 Section 4.4 in lieu of N45.2.9 Section 5.6 or the discussions in this section for Records Storage Facilities with the clarification that penetrations providing fire protection, hg hting, temperature/humidity control, or communications are acceptable as long as the penetration maintains the required fire resistance.
Except that as an alternate to these requirements non-permanent records (e.g., 3 years retention records) may be stored and maintained by the originating organization in one-hour minimum fire rated file cabinets located in environmentally controlled facilities that have suitable fire protection. Suitable fire protection is provided by either an automatic sprinkler system or a combination of two or more of the following: 1) automatic fire alarms, 2) hose stations, or 3) portable extinguishers.
2.
ANSI N45.2.9 Documents are considered completed when they are completely filled Section 1.4 out (i.e., when sufficient information is recorded to fulfill the records intended purpose) and the adequacy ofthe document(e.g., legibility) has been accepted by the document control or records management organizations or designees.
3.
ANSI N45.2.9 The requirements for an index discussed in this section are Section 3.2.2 considered to only require that a method of retrieving the record and controlling the identified information be established.
4.
ANSI N45.2.9 Instead of the requirements of this section, Entergy will comply with Section 54.2 the following: Records shall not be stored loosely. They shall be secured for storage in file cabinets or on shelving in containers.
Methods other than binders, folders, or envelopes (e.g., dividers or boxes) may be used to organize records for storage. This section is not applicable to special processed records controlled in accordance with Section 5.4.3 when the requirements ofthis section are not appropriate for the record type.
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QUALITY ASSURANCE PROGRAM MANUAL Entergy Table I Regulatory Commitments J.
Regulatory Guide 1.88 (continued)
ClarificationlException 5.
ANSI N45.2.9 Instead of the requirements of this section, Entergy will comply with Section 5.4.3 the following: Provisions shall be made for special processed records such as radiographs, photographs, negatives, microfilm, and magnetic media to prevent damage from excessive light, stacking, electromagnetic fields, temperature, and humidity as appropriate to the record type with appropriate consideration of packaging and storing recommendations as provided by the manufacturer of these materials.
6.
ANSI N45.2.9 Routine general office and nuclear site security systems and access Section 5.5 controls are provided; no special security systems are required to be established for record storage areas.
7.
ANSI N45.2.9 Entergy will meet the requirements of NFPA No. 232 I 975, Section 5.6 Standards for the Protection of Records, as allowed by the Regulatory Guide 1.88 1976 orANSI/ASME NQA-1-1983, Supplement 175-1 Section 4.4 in lieu ofthis sectionfor Records Storage Facilities with the clarification that penetrations providing fire protection, lighting, temperature/humidity control, or communications are acceptable as long as the penetration maintains the required fire resistance.
Except that as an alternate to these requirements non-permanent records (e.g., 3 years retention records) may be stored and maintained by the originating organization in one-hour minimum fire rated file cabinets located in environmentally controlled facilities that have suitable fire protection. Suitable fire protection is provided by either an automatic sprinkler system or a combination of two or more ofthe following: 1) automatic fire alarms, 2) hose stations, or 3) portable extinguishers.
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QUALITY ASSURANCE PROGRAM MANUAL Entergy Table I Regulatory Commitments K.
Regulatory Guide 1.94 Revision 1, dated April 1976
ClarificationlException 1.
ANSI N45.2.5 The last sentence requires that all items inspected with maintenance Section 2.5.2 and test equipment, which is found to be out of calibration, shall be considered unacceptable. Entergy will comply with QAPM Section B.9.g as an alternate. QAPM Section B.9.g requires an evaluation to determine the validity of previous measurements.
2.
ANSI N45.2.5 When using ACI-305-72 and ACI-306-66, Entergy may apply the Section 4.5 following requirements:
PLACING TEMPERATURES OF CONCRETE A. During hot weather concreting, placing temperatures of concrete will be limited to the following:
- 1) Concrete members less than 3 feet in least dimension will not exceed 90°F; 2) Concrete members from 3 feet to 6 feet in least dimension will not exceed 70°F; and 3)
Concrete members more than 6 feet in least dimension will have placing temperature as near 50°F as can be obtained by use of ice as necessary up to 100 percent of adding mixing water; and by shading aggregate and sprinkling the coarse aggregate the day it is to be used.
Care will be taken so that no unmelted ice remains in the concrete at the end of the mixing period.
B. During cold weather concreting: In heating the water and aggregate, live steam to heat the fine and coarse aggregate shall not be used. The permissible range for concrete temperature shall be as follows: 1) Sections less than 3 feet in least dimensions 55°F to 75°F; and 2) Mass concrete 3 feet or more in least dimension 45°F to 65° F.
The mixing water and aggregate will be purchased as required. The materials will be free of ice, snow and frozen lumps before they enter the mixer.
3.
ANSI N45.2.5 In accordance with ASME QA92-003 (ASME NQA-1 Interpretations),
Table B testing of non-shrink grout does not fall under the jurisdiction of N45.2.5 Table B; but the designer is responsible for identifying necessarytesting and frequency requirements.
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QUALITY ASSURANCE PROGRAM MANUAL Entergy Table I Regulatory Commitments K.
Regulatory Guide I.94 (continued)
ClarificationlException 4.
ANSI N45.2.5 For the performance of correlation tests, the requirements of this Section 4.8 standard may be modified as discussed below:
Table B, REINFORCING STEEL: In-process testing of reinforcing steel will include the mechanical properties of yield strength, tensile strength and percent elongation on full size specimens for each bar size for each 50 tons or fraction thereof from each mill heat. Bend tests are performed during material qualification testing only, except as noted belowfor bar sizes #14 through #18.
Table A, Required Qualification Tests as applied to reinforcing steel will include bend tests as required by ASTM A61 5 and summarized in the following: a) For bar sizes #3 through #1 1, one full size specimen from largest bar size rolled from each mill heat, unless material from one heat differs by three or more designation numbers. When this occurs, one bend test shall be made from both the highest and lowest designation number of the deformed bars rolled; b) For bar sizes #14 through #18, Supplementary Requirements SI ofASTM A615 will be applied, i.e., one fullsize specimen for each bar size for each mill heat.
If supplementary requirements are not followed for mill tests, they will be applied as in-process tests.
In-process test specimens may be selected at the rebar fabrication shop, prior to start of fabrication of the rebar from the heat or fraction thereof represented by the test specimen.
Acceptance criteria for any failed test (qualifications as well as in-process) may be the same as that for tensile tests specified in Subarticle CC-2331.2 of ASME Section III, Div. 2 Code (1 975). This states that if a test specimen fails to meet the specified strength requirements, two (2) additional specimens from the same heat and of the same bar size would be tested, and if either of the two additional specimens fails to meet the specified strength requirements, the material represented by the tests would be rejected for the specified use. Alternative use of rejected material under strict control may be subject to evaluation by engineering.
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QUALITY ASSURANCE PROGRAM MANUAL Entergy Table I Regulatory Commitments K.
Regulatory Guide I.94 (continued)
ClarificationlException 5.
ANSI N452.5 Entergy may interpret the terms horizontal, vertical and diagonal bars Section 4.9 to apply respectively to the following types of splice positions: a.
Horizontal, including 100 to horizontal; b. Vertical, including Q0 to vertical; and c. 45° angle, including 100 to 800 angle. The words splicing crew are interpreted to refer to all project members that are actively engaged in preparing and assembling cadweld mechanical splices at the final splice location. Separate test cycles will be established for each bar size and each splice position.
6.
ANSI N45.2.5 Entergy will comply with inspection requirements of the applicable Section 5.5 welding codes and any exceptions instead ofthis section.
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QUALITY ASSURANCE PROGRAM MANUAL Entergy Table I Regulatory Commitments L.
Regulatory Guide 1.116 Revision O-R, dated June 1976 ClarificationlException 1.
ANSI N45.2.8 Documented routine inspections and audits ofthe storage area may Section 3 be performed instead ofthe requirements ofthis section.
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QUALITY ASSURANCE PROGRAM MANUAL Entergy Table I Regulatory Commitments M.
Regulatory Guide 1.123 Revision 1, dated July 1977 ClarificationlException 1.
RG 1.123 This paragraph shall be implemented as originallywritten in Paragraph C.6.e N45.2.13 (i.e., with the verb should instead of the verb shall).
Entergy retains the ultimate responsibility for performance of purchased equipment. The appropriate engineering discipline will exercise this management/engineering prerogative with respect to the final decision on post installation test requirements.
2.
ANSI N45.2.13 Item c is an option which may be used to assure quality; Section 1.2.2 however, any option given in 10 CFR 50 Appendix B, Criterion VII as implemented by the QAPM may also be used.
3.
ANSI N45.2.1 3 Instead of the definition provided for QA Program Requirements, Section 1.3 Entergy will comply with the following: Those individual requirements of the QAPM which, when invoked in total or in part, establish quality assurance program requirements for the activity being controlled. Although not specifically used in the QAPM, ANSI N45.2 may be imposed upon suppliers.
4.
ANSI N45.2.13 The same degree of control is stipulated to mean equivalent Section 3.1 level of review and approval. The changed document may not always be reviewed by the originator; however, at least an equivalent level of management/supervision shall review and approve any changes.
5.
ANSI N45.2.13 Changes to procurement documents which are changes in Section 3.1 quantity, estimated price, cost codes, taxes, format or editorial changes that do not affect the quality of the item or service do not require an equivalent level of review and approval as the original document.
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QUALITY ASSURANCE PROGRAM MANUAL Entergy Table I Regulatory Commitments M.
Regulatory Guide 1.123 (continued)
ClarificationlException 5a.
ANSI N45.2.13 When purchasing commercial-grade (as defined in IOCFR2I)
Section 3.2 calibration services from NVLAP or A2LA accredited calibration laboratories, procurement documents are not required to impose a quality assurance program consistentwith ANSI N45.2-1971.
In such cases, accreditation may be accepted in lieu of the Purchaser imposing a QA Program consistent with ANSI N45.2-1 971
, provided all the following are met:
The accreditation is to ANSI/ISO/IEC 17025.
The accrediting body is either NVLAP A2LA.
The published scope of accreditation for the calibration laboratory covers the needed measurement parameters, ranges, and uncertainties.
The purchase documents require calibration/report to include identification of the laboratory equipment/standards used.
The purchase documents require reporting as-found calibration data when calibrated items are found to be out-of-tolerance.
6.
ANSI N45.2.1 3 The requirements of the QAPM will be implemented instead of Section 3.4 this section.
7.
ANSI N45.2.1 3 Supplier evaluations may be performed any time prior to placing Section 4.2 the purchased item in service.
8.
ANSI N45.2.13 Non-conformance notices for conditions described in this section Section 8.2 are only required to be submitted to Entergy when the non-Item b conformance could adversely affect the end use of an item relative to safety, interchangeability, operability, reliability, integrity or maintainability.
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QUALITY ASSURANCE PROGRAM MANUAL Entergy Table I Regulatory Commitments M.
Regulatory Guide 1.123 (continued)
ClarificationlException 9.
ANSI N45.2.1 3 The section states that the certificate should be attested to by a Section 1 0.2 person who is responsible for this QA function whose function Item d and position are described in the Purchasers/Suppliers QA program. As an alternate to this requirement, Entergy will use the following:
The person attesting to a certificate shall be an authorized and responsible employee ofthe supplier, and shall be identified by the supplier.
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QUALITY ASSURANCE PROGRAM MANUAL Entergy Table I Regulatory Commitments N.
Regulatory Guide 1.144 Revision 1, dated September 1980 e
ClarificationlException 1.
RG 1144 This section is not applicable.
Section C.3.a.(2) 2.
RG I.144 In addition to the requirements of this section, previously evaluated Section C.3.b.(2) and approved active suppliers for which auditing is not the selected method of source verification should be evaluated concurrent with the award of a contract. Regardless of the evaluation results, active suppliers (except those excluded under C.3.b(1 )) are source verified (audit, surveillance or inspection) within two years prior to award of a contract or have source verification performed. Inactive suppliers are evaluated prior to supplying items or services. An audit shall be conducted if required to determine the acceptability of procured items or services (i.e., acceptability cannot be determined by receipt inspection or another method allowable under I 0 CFR 50 Appendix B, Criterion VII).
3.
RG I.144 This section requires that supplier audits be performed on a Section C.3.b.(2) triennial basis. A 90-day grace period may be applied to this activity. For activities deferred in accordance with the 90-day grace period, the next performance date will be based on their originally scheduled date.
4.
RG 1.144 Instead ofthe annual documented evaluation of suppliers Section C.3.b.(2) discussed in this section, an ongoing evaluation of supplier performance is conducted which takes into account, where applicable, the other considerations of this section and paragraph of the Regulatory Guide.
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QUALITY ASSURANCE PROGRAM MANUAL Entergy Table I Regulatory Commitments N.
Regulatory Guide 1.144 (continued)
. ClarificationlException 4a.
RG I.144 For suppliers of commercial-grade (as defined in IOCFR2I)
Section C.3.b.(2) calibration services with accreditation by NVLAP or A2LA, a documented review of the suppliers accreditation by the purchaser may be used in lieu of performing an audit, accepting an audit by another licensee, performing a commercial-grade survey, inspecting or testing following delivery, or performing in-process surveillances during performance of the service. This review shall include, at a minimum, verification of all the following:
The accreditation is to ANSI/ISO/IEC 17025.
The accrediting body is either NVLAP A2LA.
The published scope of accreditation for the calibration laboratory covers the needed measurement parameters, ranges, and uncertainties.
5.
ANSI N45.2.12 Pre-audit and post-audit conferences may be fulfilled by a variety of Section 4.3.1 communications, such as telephone conversation.
6.
ANSI N45.2.12 Pre-audit and post-audit conferences are only held when deemed Section 4.3.1 necessary by quality assurance or when requested by the audited organization.
7.
ANSI N45.2.12 This subsection could be interpreted to limit auditors to the review Section 4.3.2.2 of only objective evidence; sometimes and for some program elements, no objective evidence may be available. Entergy will comply with an alternate sentence which reads: When available, objective evidence shall be examined for compliance with QAPM requirements.
If subjective evidence is used (e.g., personnel interviews) then the audit report must indicate how the evidence was obtained.
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QUALITY ASSURANCE PROGRAM MANUAL Entergy Table I Regulatory Commitments N.
Regulatory Guide 1.144 (continued)
ClarificationlException 8.
ANSI N45.2.12 Pre-audit and post-audit conferences are only held when deemed Section 43.3 necessary by quality assurance or when requested by the audited organization.
9.
ANSI N45.2.12 Pre-audit and post-audit conferences may be fulfilled by a variety of Section 4.3.3 communications, such as telephone conversation.
Jo.
ANSI N45.212 Instead ofthe lastsentence ofthe Iastparagraph ofthe section, Section 4.4 Entergy will comply with the following: The audit report shall be issued within thirty working days after the last day of the audit. The last day of an audit shall be considered to be the day of the post-audit conference. If a post-audit conference is not held because it was deemed unnecessary, the last day of the audit shall be considered to be the date the post-audit conference was deemed unnecessary as documented in the audit report.
11.
ANSI N45.2.12 The QAPM Section A.6 corrective action program may be used Section 4.5. 1 instead of these requirements as long as the appropriate time limits are applied to significant conditions adverse to quality. Also, no additional documentation is necessary if needed corrective actions are taken and verified prior to audit report issuance.
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QUALITY ASSURANCE PROGRAM MANUAL
- Entergy Table I Regulatory Commitments 0.
Regulatory Guide 1.146 Revision 0, dated August 1980 ClarificationlException I.
ANSI N45.2.23 Holders of NRC-issued Reactor Operator/Senior Reactor Operator Section 2.3. 1.3 Licenses comply with the requirements of this section and may be awarded two credits.
2.
ANSI N45.2.23 Prospective lead auditors shall demonstrate their ability to effectively Section 2.3.4 implement the audit process and lead an audit team. They shall have participated in at least one audit within the year preceding the individuals effective date of qualification. Upon successful demonstration of the ability to effectively lead audits, licensee management may designate a prospective lead auditor as a lead auditor.
3.
ANSI N45.2.23 These sections require that an annual assessment be performed of Sections 3.2 and each lead auditors qualification and that each lead auditors records 5.3 be updated annually. A 90-day grace period may be applied to these activities. For activities deferred in accordance with the 90-day grace period, the next performance due date will be based on their originally scheduled date.
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