ML032170606
| ML032170606 | |
| Person / Time | |
|---|---|
| Site: | Pilgrim |
| Issue date: | 07/24/2003 |
| From: | Riggs W Entergy Nuclear Operations |
| To: | Document Control Desk, Office of Nuclear Reactor Regulation |
| References | |
| 2.03.078 | |
| Download: ML032170606 (37) | |
Text
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Entergy Nuclear Operations, Inc.
.Ld
<ttl DV Pilgrim Station
""OEntergy 600 Rocky Hill Road Plyrnouth, MA 02360 William J. Riggs Director, Nuclear Assessment July 24, 2003 U. S. Nuclear Regulatory Commission Document Control Desk Washington, DC 20555
SUBJECT:
Entergy Nuclear Operations, Inc.
Pilgrim Nuclear Power Station Docket No. 50-293 License No. DPR-35 Changes to the Quality Assurance Program Description for Pilgrim Nuclear Power Station
REFERENCES:
Entergy Operations, Inc. letter dated April 24, 2003 to U.S. NRC, Entergy Quality Assurance Program Manual, Revision 8 LETTER NUMBER:
2.03.078
Dear Sir or Madam:
As required by 10 CFR 50.54(a)(3), Entergy Nuclear Operations, Inc. submits the report of changes made to the Quality Assurance Program for Pilgrim Nuclear Power Station (Pilgrim Station). This report covers the period from July 2001 and addresses those program changes made up to and including May 6, 2002 at which time Pilgrim Station adopted the Entergy QA Program.
The changes made to the Entergy QA Program after Pilgrim Station's adoption of the Entergy QA Program were submitted to the NRC as required by 10 CFR 50.54(a)(3) in an Entergy letter dated April 24, 2003 (Reference). The reporting of future changes to the Entergy QA Program in a manner similar to the Reference letter will eliminate the need for Pilgrim Station to submit a separate, duplicate 10 CFR 50.54(a)(3) report in the future.
Enclosure A begins with a summary of the five changes processed during the reporting period that were made to the Pilgrim Quality Assurance Program Manual (PQAM) that preceded the adoption of the Entergy QA Program. The changes are listed at the end of the summary and are further detailed in the attachments to the Enclosure. Where noted on the leader page for an attachment to the Enclosure, additional documentation is not included in this submittal but is available for inspection.
203078 bo8 t
I.
Entergy Nuclear Operations, Inc.
Letter Number: 2.03.078 Pilgrim Nuclear Power Station Page 2 Five PQAM Change Requests were processed during the reporting period. These changes were part of an effort to revise the entire PQAM to reflect the sale and license transfer of Pilgrim Station to Entergy that occurred on July 13, 1999. The intent of the changes was to effect changes that were necessary to implement standardized Entergy processes and, at the same time, transition to the Entergy QA Program. Each change request provides a description of the change, the reason for the change, and the basis for continued compliance with 10 CFR 50 Appendix B. The results of reviews conducted under the Direct Final Rule [64 FR 9029] are included, as appropriate.
Please feel free to contact Bryan Ford, (508) 830-8403, if there are any questions regarding this subject.
Sincerely, dia
.Ri DWE/dd
Enclosure:
(A)
Report of Pilgrim Quality Assurance Manual Changes (July 2001 through May 2002) - 34 pages cc:
Mr. Travis Tate Project Manager U.S. Nuclear Regulatory Commission 1 White Flint North Mail Stop 0-8B-1A 11555 Rockville Pike Rockville, MD 20852 Mr. Hubert Miller Region I Administrator U.S. Nuclear Regulatory Commission 475 Allendale Road King of Prussia, PA 19406 Senior NRC Resident Inspector
ENCLOSURE A Report of Pilgrim Quality Assurance Manual Changes (July 2001 through May 2002)
(34 pages)
~Entergy REPORT OF PILGRIM QUALITY ASSURANCE MANUAL CHANGES July2001 through May2002 Summary of Chances In order to reflect Entergy's ownership of Pilgrim, the revised organizational structure, and the realignment of responsibilities in effect after the transfer of the Station's operating license to Entergy Nuclear Generating Company, an effort to completely rewrite the Pilgrim Quality Assurance Program was undertaken. The intent of this effort was to make the required changes and at the same time increase corporate QA program flexibility by presenting discussion in a manner consistent with the format and level of detail prescribed in the Entergy QA Program applicable to its other nuclear stations.
During the reporting period, five PQAM Change Requests were processed. The first four involve Sections 1, 2, and 16 of the program document, which were issued with the initial intent to transition to the Entergy QA Program Manual via individual revisions to the 18 sections within the Pilgrim QA Manual. As part of a larger corporate Entergy Nuclear Northeast fleet effort, the fifth change adopts the entire Entergy QA program (May 6, 2002). The adopted Entergy QA program, which has been previously approved by the NRC (TAC # M97893) was filed on the Pilgrim docket under NRC TAC #
ML021280592 date 04/27/02. Changes made to the Entergy QA Program since its adoption by PNPS were submitted to the NRC in an Entergy letter dated April 24, 2003.
The detailed evaluations of the changes made are documented in Attachments A, B, C, D and E. These attachments contain the 10CFR50.54(a) evaluations generated during the preparation and issuance of these revisions, which provide a clear description of each change, the reason for these changes, and the basis for continued 1 OCFR50, Appendix B compliance.
As appropriate, the results of reviews involving program changes within the scope of Direct Final Rule [64 FR 9029] and subsequent revision to 1 OCFR50.54(a) are also provided.
PQAM Change Descriptions
- 1. POAM Change Request No. 01 Section 1. "Organization" Revision 1, 09/30/01 Change Identification:
Section 1, Organization, was completely rewritten to address the Entergy Nuclear Northeast (ENN) introduction of a regional corporate structure and the assignment of responsibilities within the Pilgrim Nuclear Power Station (PNPS) organization to executive positions located in the headquarters of Entergy Nuclear Generating Company. In general, the previous wording of Section 1, which addresses the Pilgrim organization by identifying the roles and responsibilities of key positions, departments and groups has been replaced with text that describes the organization from a functional area perspective Reason for Changes:
This revision to Section 1 was necessary in order to effectively describe the revised organizational structure and the realignment of functional responsibilities under a SRP 17.3 format. The change from a format consistent with SPR 17.1 to a format consistent with SRP 17.3 was made to achieve consistency with the Entergy Operations Incorporated QA Manual.
Basis of Continued 10CFR50. Appendix B Compliance:
The changes have been evaluated as having no adverse program effect. The revised text effectively addresses the applicable criteria of 10CFR50, Appendix B and continues to support compliance with this regulation.
The changes pertain to the deletion of the detailed descriptions of duties, roles and responsibilities within the PNPS Organization. The elimination of the text has changed the QA Program previously approved by the NRC. Accordingly, these changes were determined to be potential reductions in QA program commitments.
The evaluation under PQAM Change Request No. 01-01 concludes that the new method of describing the Station organization, are acceptable without prior NRC approval, under 10CFR50.54(a)(ii);
"The use of a quality assurance alternative or exception approved by an NRC safety evaluation provided the bases of the NRC approval are applicable to the licensee's facility."
The PNPS 50.54(a) evaluation establishes that the bases of the NRC approval are acceptable for application at Pilgrim Station. Accordingly, these changes provide an effective description of the PNPS organization and are fully responsive to Criteria 1 of 1 OCFR50, Appendix B. See Attachment A for details.
- 2. POAM Change Reguest No. 01 Section 2. "-igaitv Assurance Program' Revision 0, 01/03/02 Chanae Identification:
Section 2 was completely rewritten. It reflects the establishment of the ENN common processes for the Off-Site and On-site Safety Review Committees. The Entergy exceptions and clarifications pertaining to ANSI N18.7 have been captured within the revised text of PQAM section 2. The balance of the change made to section 2 reflect the sale of PNPS to Entergy, the resultant organization structure and current position titles.
Reason for Chances:
This revision to Section 2 was necessary to enable the application of standard Entergy Nuclear Northeast (ENN) Off-site and On-site Safety Review Committee functions. Changes were necessary to reflect the sale of Pilgrim Station to Entergy Nuclear Generating Company, the resultant changes in the organization structure and revised position titles.
Basis of Continued 1 0CFR50. Appendix B Compliance:
This change modifies the present PQAM commitment to comply with the regulatory guides and ANSI Standards without alternatives or exceptions. Entergy has previously consolidated the individual QA programs of stations operated by Entergy Operations Incorporated through the development of a common QA Manual. The development of the program involved changes that were less restrictive than previously stated requirements and the manual was submitted for -NRC approval.
These included the clarifications and exceptions to N18.7 and the changes in the safety review committee functions. The NRC approval of these changes is documented in a safety evaluation report (TAC # M97893). The adoption of the Entergy exceptions and clarifications pertaining to ANSI N18.7 is acceptable under the allowances of 1 OCFR50.54(a)(3)(ii);
'The use of a quality assurance alternative or exception approved by an NRC safety evaluation provided the bases of the NRC approval are applicable to the licensee's facility."
The PNPS 50.54(a) evaluation establishes that the bases of the NRC approval are applicable to the Pilgrim Station. The balance of the changes are administrative changes which are allowed under 10CFR50.54(a)(3). Accordingly, these changes provide an effective description of the PNPS organization and are fully responsive to Criteria 2 of 1 OCFR50, Appendix B. See Attachment B for details.
- 3. POAM Chanae Request No. 01 Section 1. "Organization" Revision 2, 01/03/02 Change Identification:
Section 1, Organization, was revised to reflect the regional headquarter based Off-site Safety Review Committee and the revised reporting chain of this function to Entergy Nuclear Northeast management. The change also includes the relocation of a commitment, for the On-Site Safety committee quorum to include a member or alternate with a Senior Reactor Operators license, from the FSAR to the QA Program.
Reason for Changes:
This revision to Section 1 was necessary to enable the application of standard Entergy Nuclear Northeast (ENN) Off-site and On-site Safety Review Committee functions.
Basis of Continued 10CFR50. Appendix B Compliance:.
The changes to Section 1 are administrative and have no adverse impact on the PQAM or its commitments. Accordingly these changes are allowed to be made under 1 OCFR50.54(a)(3) without NRC approval. See Attachment C for details.
- 4. POAM Chance Request No. 02-01 -Section
- 16. "Corrective Action" Revision 0, 03/26/02 Change Identification:
This section was rewritten in its entirety to provide a level of discussion consistent with that of the common Entergy QA Manual, which is formatted in accordance with the Standard Review Plan (SRP) 17.3. The existing text addresses the criteria format of 10CFR50 Appendix B. The SRP format of 17.3 addresses the criteria of 1 OCFR50, Appendix B within three primary program elements identified as Management, PerformanceNerification and Self Assessment activities.
Reason for Chanqes:
This revision to Section 16 was part of the overall effort to rewrite the entire Pilgrim QA Program in a manner consistent with the Entergy common QA Program description.
Basis of Continued 1 0CFR50. Appendix B Compliance:
This revision describes the existing Pilgrim corrective action control measures with a minimal level of detail. While non-essential descriptive text, implementing detail, and discussion relative to responsible functional groups have been deleted, the level of discussion in the proposed revision effectively addresses the requirements of criterion 16 of 10CFR50, Appendix B and PNPS commitment to Regulatory Guide 1.33, including associated ANSI Standard N18.7.
Entergy has previously consolidated the individual QA programs of stations operated by Entergy Operations Incorporated through the development of a common QA Manual. The development of the program involved changes that deleted non-essential descriptive text, implementing detail, and discussion relative to responsible functional groups and the manual was submitted for NRC approval. The NRC approval of these changes is documented in a safety evaluation report (TAC #
M97893).
The verbatim adoption of the Entergy text is acceptable under the allowances of 1 OCFR50.54(a)(3)(ii);
'The use of a quality assurance alternative or exception approved by an NRC safety evaluation provided the bases of the NRC approval are applicable to the licensee's facility."
The PNPS 50.54(a) evaluation establishes that the bases of the NRC approval of these changes are applicable to the Pilgrim Station. The text incorporated is verbatim of the Entergy text approved by the NRC. Accordingly, these changes provide an effective description of the PNPS corrective action program and are fully responsive to Criteria 16 of 10CFR50, Appendix B. See Attachment D for details.
- 5. POAM Change Request No. 02 ALL Sections Revision - various Change Identification:
The existing Pilgrim QA program description is being replaced through the adoption of the common Entergy Quality Assurance Program Manual (QAPM) for application at the Pilgrim Nuclear Power Station. The adoption represents a rewriting of the entire PNPS QA Program Description under a completely different format.
Reason for Chanqes:
This change provides the transition from the legacy (pre-Entergy) Pilgrim Nuclear Power Station QA program description to the common QA program description for the entire Entergy fleet of Nuclear Power Plants.
Basis of Continued 10CF150. Appendix B Compliance:
A comprehensive line-by-line review of the PNPS QA Program Manual against the Entergy QA Program Manual was performed. The evaluation was performed in two phases. Phase I identified and evaluated changes to the existing PQAM text. Phase II identified and evaluated the changes realized by the assumption of commitments to later editions of regulatory guides and associated alternatives to the guidance that was not addressed with the existing Pilgrim QA program description.
The majority of the changes have been made to reflect the sale of PNPS to Entergy; the resultant changes in organization structure; the elimination of descriptive text and implementing detail not necessary under Standard Review Plan 17.3 format and the deletion text that is duplicative of that contained in a QA standard that PNPS is committed to. Each change was directly identified against the criteria of 1 OCFR50.54(a)(3).
In the application of 1 OCFR50.54(a)(3)(ii) the NRC safety evaluation reports associated with the common QA program submittals by Entergy Operations, Inc (EOI) (reference NRC TAC M9783) and/or First Entergy Nuclear Operating Company (reference NRC TAC MB0914 and TAC MB0915) were utilized. The PNPS 50.54(a) evaluations establish that the bases of the NRC approval of these changes are applicable to the Pilgrim Station.
The PNPS 50.54(a) evaluation establishes that these changes are not considered reductions of commitments per 10CFR50.54(a)(3). See Attachment E for details.
The text incorporated is verbatim of the Entergy text approved by the NRC as meeting the requirements of 10CFR50, Appendix B. Accordingly, these changes provide an effective description of the PNPS QA program and are fully responsive to the 18 Criteria of 1 OCFR50, Appendix B.
Attachments:
A.
PQAM Section I - PQAM Change Request No. 01-01 B.
PQAM Section 2 - PQAM Change Request No. 01-02 C.
PQAM Section 1 - PQAM Change Request No. 01-03 D.
PQAM Section 16-POAM Change Request No. 02-01 E.
PQAM All Sections - PQAM Change Request No. 02-02
Attachment A PQAM Section PQAM Change Request No. 01-01 Please note that the change request refers to Attachment 1 that is not attached in this transmittal but is available for inspection.
RTYPE: A2.23 AM
--E~i tei~y PILGRIM NUCLEAR POWER STATION PILGRIM QUALITY ASSURANCE MANUAL (PQAM)
CHANGE REQUEST NO.
01-01 SECTION 1
REV. NO.
1 PARAGRAPH NO.
All PAGE NO.
All REVISION (exact wording)
This section has been rewritten in its entirety; therefore, no mark-up of Revision 0 is provided anid no revision bars are ingluded in the new revision (Revision 1).
See Attachment 1 for information relative to the existing text, the disposition of this text, and the revised wording.
PURPOSE OF REVISION
- 1. Revise description of the PNPS organization consistent with the introduction of a regional organization under Entergy Nuclear Northeast.
- 2. Complete rewrite to reformat text and provide a level of discussion consistent with the Entergy Nuclear Southwest QA Manual.
'ORIGINATOR
&=
e Date
-3CO-1 EFFECTIVE DATE APPROVAL SIGNATURES VICE PRESIDENT, Date OPERATIONS PILGRIM 7aj~ a, 8 /144il
- DIRECTOR, I Dfte DESIGN ENGINEERING/
V4e9fMP1GGT,-
t y STATION DIRECTOR DNU A AOR, NUCLEAR ASSESSMENT Date Dat/4e Date
QA PROGRAM CHANGE EVALUATON PQAM Change Request No.
01-01 Section No.
1 Rev.
I EVALUATION Does the above change to the QA Program reduce the commitments concerning:
Yes No O U 10CFR50, Appendix B O U Program coverage documentation (policies, procedures, or inspections) 0 U
Policy, procedure, or instruction compliance O U Identification of structure systems, and components O U Identification of major participating organizations and their designated func-tions O U Providing control over activities affecting the quality of the identified structures, systems, and components O U Controlling conditions under which activities affecting quality are to be accom-plished (e.g., equipment, environmental conditions, prerequisites)
O E Attaining required quality (e.g., special controls, processes, test equipment, tools, or skills)
O Uo Verification of quality by inspection and test O U Providing indoctrination and training of personnel performing activities affecting quality o 1 Regularly reviewing the status and adequacy of the QA Program O K Periodic review for status and adequacy by participating organization Manag-ers of the part of the QA Program which they are executing O
Other (explain) - none -
QA PROGRAM CHANGE EVALUATION (cont.)
POAM Change Request No.
01-01 CONCLUSION Section 1 of the Pilgrim Quality Assurance Program, as revised, continues to sat-isfy 1 OCFR50J Appendix B. The changes made within this section meet the crite-ria within 10CFR50.54(a)(3) relative to QA program changes that can be made without prior NRC approval.
Notwithstanding the four changes dispositioned as reductions in commitment, the balance of changes have no adverse program effect and provide an effective description of the PNPS organization within Entergy Nuclear Northeast.
Under 10CFR50.54(a)(3), the reductions in commitment are also allowed to be made without prior NRC approval based on the evaluated application of previously issued NRC Safety Evaluation Reports.
CHANGE EVALUATION With the acquisition of additional plants, Entergy Nuclear Northeast (ENN) has assumed a regional corporate organizational structure very similar to that of Entergy Nuclear Southwest (ENS). The revised PNPS organizational structure includes executive positions located at the headquarters office that are assigned responsibilities under the PNPS QA Program. Using text that is essentially the same as the organizational description contained in the ENS QA Program document, PQAM Section 1 has been revised to reflect the introduction of an ENN regional organization in a manner that maximizes consistency between the ENN and ENS QA Program documents. The revision also reflects recent changes to the PNPS site organization and the associated re-alignment of functional area responsibilities.
Detailed evaluation of the revision is documented in Attachment 1. This attachment provides a verbatim copy of the previous Section 1 in a matrix form that documents the disposition of text as compared to the associated wording contained in the new revision. For each change, a documented evaluation is also provided regarding the impact of the change on the QA Program and its disposition under 10CFR50.54(a)(3) criteria.
As indicated in Attachment 1, the majority of changes have no adverse program effect. These changes are within the allowances of 10CFR50, Appendix B and effectively describe the current organization responsible for the safe operation of PNPS. However, the following four changes are determined to be reductions in commitment.
a Deletion of text that refers specifically to the ISI and receipt inspection duties of the manager responsible for Quality Assurance.
Deletion of text that refers specifically to the In-Service Test duties of the manager responsible for Engineering.
Elimination of text that addresses the function and responsibilities of the manager responsible for Emergency Preparedness.
Elimination of text relative to the position of the manager responsible for Regulatory Relations.
While each of these changes is determined to be within the allowances of 1 OCFR50, Appendix B, they are considered to be reductions in commitment under 10CFR50.54(a) in that the elimination of text has changed the QA Program description previously approved by the NRC.
However, these changes are allowed to be made without prior NRC approval via-application of the criteria within 10CFR50.54(a)(3)(ii).
Under this regulation, changes that reduce QA Program commitments can be made without prior NRC approval based on:
"The use of a quality assurance alternative or exception approved by an NRC safety evaluation, provided that the bases of the NRC approval are applicable to the licensee's facility."
The deletion of text that refers to specific PNPS organization positions and/or their assigned duties are changes that are essentially the same as program revisions previously made under the ENS consolidated QA Program document approved by the NRC. The details of these ENS QA Program changes and their approval by the NRC are contained in Notes 7 and 10 of Attachment 1. As indicated within these notes, the NRC's approval basis for these changes has been evaluated and found acceptable for application towards the PNPS QA Program changes.
Accordingly, prior NRC approval of these changes is not required.
In total, all text changes made within the revision are acceptable. These changes provide an effective description of the PNPS organization and are fully responsive to Criterion 1 of 10CFR50, Appendix B.
Prepared by:
Late Cognizant OA Engineer
'Date Approved by:
Superintendent, INclear (QA)
Date Manag'e/, Tean(QA Assessment)
Date
/
Attachment B PQAM Section 2 -
PQAM Change Request No. 01-02
RTYPE: A2.23 Ene PILGRIM NUCLEAR POWER STATION PILGRIM QUALITY ASSURANCE MANUAL (PQAM)
CHANGE REQUEST NO.
01-02 SECTION 2 REV. NO.
0 -
PARAGRAPH NO.
All PAGE NO.
All REVISION (exact wording)
See attached marked revision.
PURPOSE OF REVISION
- 1. Add ANSI Standard N18.7 clarifications and exceptions under PQAM commit-ments to Regulatory Guide 1.33 to enable the application of a standard Entergy Nuclear Northeast (ENN) Off-site and On-site Safety Review Committee func-tions.
- 2.
Revise text as necessary to reflect the sale of PNPS to Entergy, the resultant changes in organizational structure, and revised position titles.
01-0A -04;L EFFECTIVE DATE OF POAM SECTION APPROVAL SIGNATURES H~~or Julepsk QUALIT ASSURANCE MANAGER Date SI T
Date GENERAL MANAGERA/
I 9 IDate
QA PROGRAM CHANGE EVALUATION PQAM Change Request No.
01-02 Section No.
2 Rev.
0 EVALUATION Does the above change to the QA Program reduce the commitments concerning:
Yes No O U 10CFR50, Appendix B U U Program'coverage documentation (policies, procedures, or inspections)
U U Policy, procedure, or instruction compliance (exception to Reg Guide 1.33)
U U Identification of structure systems, and components 13 Identification of major participating organizations and their designated func-tions U U Providing control over activities affecting the quality of the identified structures, systems, and components U H Controlling conditions under which activities affecting quality are to be accom-plished (e.g., equipment, environmental conditions, prerequisites)
U U Attaining required quality (e.g., special controls, processes, test equipment, tools, or skills)
U U Verification of quality by inspection and test Cl E
Providing indoctrination and training of personnel performing activities affecting quality U E Regularly reviewing the status and adequacy of the QA Program U U Periodic review for status and adequacy by participating organization Manag-ers of the part of the QA Program which they are executing U U Other (explain) -- none -
Page 1 of 1
QA PROGRAM CHANGE EVALUATION (cont.)
POAM Change Request No.
01-02 CONCLUSION Section 2 of the Quality Assurance Program for Pilgrim Station, as revised, continues to satisfy 10CFR50, Appendix B by providing an effective description of program scope, applicability, and control measures. The changes made within this section meet the criteria within 10CFR50.54(a) relative to QA program changes that can be made without prior NRC approval.
The administrative changes are allowed to be made under 10CFR5O.54(a)(3).
The addition of clarifications and/or exceptions to Regulatory Guide 1.33 relative to the On-site and Off-site Safety Review Committees are allowed under 10CFR50.54(a)(3)(ii) based on the evaluated application of a previously issued NRC Safety Evaluation Report.
CHANGE EVALUATION In addition to making the changes necessary to reflect the transition to standard review committee functions, this revision to PQAM Section 2 corrects the existing text to address the sale of PNPS to Entergy, the resultant revised organizational structure, and changes to position titles.
With the acquisition of additional plants, Entergy Nuclear Northeast (ENN) has assumed a regional corporate organizational structure. As a result, management has selected several functions and processes to be executed under standardized methodologies and common procedures. Two of these efforts include establish-ing common processes for the Off-site and On-site Safety Review Committees' functions. To maximize consistency within Entergy, ENN is modeling its review committee functions after those of Entergy Nuclear South (ENS), as established in the ENS QA Program and described in Nuclear Management Manual Procedures.
While the existing POAM text and commitments to Regulatory Guide 1.33 are identical to those in the ENS QA Manual, the transition to common On-site and Off-site Safety Review Committees' functions requires adoption of ANSI N18.7 exceptions and clarifications contained in the ENS QA Manual. These clarifica-tions and exceptions address safety committee make-up, conduct, and scope of review responsibilities relative to the criteria of ANSI N18.7. They enable the exe-cution of On-site and Off-site Safety Review Committees' functions as described Page 2 of 2
in Nuclear Management Manual Procedures. These exceptions and clarifications have been captured within the revised text of PQAM Section 2.
This change modifies the present PQAM commitment to comply with the regula-tory guide and ANSI standard without alternatives or exceptions. The adoption of ENS exceptions and clarifications pertaining to ANSI N18.7 is acceptable under the allowances of 10CFR50.54(a)(3)(ii). Based on the evaluated application of a previously issued Safety Evaluation Report, these changes can be without prior NRC approval.
Previously, ENS consolidated the individual QA Programs of regulated stations operated by Entergy Operations Incorporated through the development of the common ENS QA Manual. The development of this program involved changes that were less restrictive than previously stated requirements and the manual was submitted to the NRC for approval. With respect to the On-site and Off-site Safety Review Committees, the consolidated QA Program addresses the existence and reporting chain of these functions, commits to Regulatory Guide 1.33, and identi-fies several clarifications and exceptions to ANSI N18.7. These clarifications and exceptions were necessary to execute the common review committee processes described in implementing procedures. The description of these review functions and the ANSI standard exceptions were approved by NRC as documented under Safety Evaluation Report (TAC # M97893). The revision to POAM Section 2 util-izes the same text, Regulatory Guide commitments, and exceptions and clarifica-tions to establish and describe the PNPS safety review committee functions. Ac-cordingly, the bases of the NRC's approval of the common Entergy QA Program is considered acceptable for application at PNPS.
The balance of changes made to Section 2 reflect the sale of PNPS to Entergy, the resultant organizational structure, and current position titles. These changes are administrative in nature and have no adverse program effect.
None of the changes made to Section 2 has an adverse program effect. The POAM continues to comply with 1 OCFR50, Appendix B and the revision under the allowances of 10CFR50.54(a)(3)(ii) can be implemented without prior NRC approval.
Prepared by:
Z.
,k gnoan EKfin-e~er Date Approved by:
I
/c 7
/
e/,Cv QA Manager Date Page 3 of 3
Attachment C PQAM Section I PQAM Change Request No. 01-03
RTYPE: A2.23 a
- Entery PILGRIM NUCLEAR POWER STATION PILGRIM QUALITY ASSURANCE MANUAL (PQAM)
CHANGE REQUEST NO.
01-03 SECTION 1
REV. NO. 2 PARAGRAPH NO.
1.3.1 PAGE NO.
2 REVISION (exact wording)
See attached marked revision.
PURPOSE OF REVISION
- 1. To reflect the introduction of a regionally headquartered based Off-site Safety Review Committee and the revised reporting chain of this function to management.
- 2. To relocate the commitment for the On-site Safety Review Committee quorum to include a member or alternate with a Senior Reactor Operator license from the UFSAR to the QA Program.
O I-O-5O?
EFFECTIVE DATE OF PQAM SECTION APPROVAL SIGNATURES SITE VICE PRESIDENT ate
QA PROGRAM CHANGE EVALUATION PQAM Change Request No.
01-03 Section No.
1 Rev.
2 EVALUATION Does the above change to the QA Program reduce the commitments concerning:
Yes No L
U 1 OCFR50, Appendix B
\\
o K
Program coverage documentation (policies, procedures, or inspections)
U U Policy, procedure, or instruction compliance (exception to Reg Guide 1.33)
U U Identification of structure systems, and components O U Identification of major participating organizations and their designated func-tions O U Providing control over activities affecting the quality of the identified structures, systems, and components a U Controlling conditions under which activities affecting quality are to be accom-plished (e.g., equipment, environmental conditions, prerequisites) 0 U Attaining required quality (e.g., special controls, processes, test equipment, tools, or skills)
U
- Verification of quality by inspection and test O U Providing indoctrination and training of personnel performing activities affecting quality O
- Regularly reviewing the status and adequacy of the QA Program U
- Periodic review for status and adequacy by participating organization Manag-ers of the part of the QA Program which they are executing U U Other (explain) -- none -
Page 1 of 1
QA PROGRAM CHANGE EVALUATION (cont.)
POAM Change Request No.
01-03 CONCLUSION Section 1 of the Quality Assurance Program for Pilgrim Station, as revised, continues to satisfy 1 OCFR50, Appendix B by providing an effective description of the Entergy Nuclear Northeast (ENN) organization responsible for the safe operation of PNPS.
The changes made relative to the On-site and Off-site Review Committees have no adverse impact on program requirements or commitments. These changes meet the criteria within 10CFR50.54(a)(3) relative to QA program changes that can be made without priorNRC approval.
CHANGE EVALUATION With the acquisition of additional plants, Entergy Nuclear Northeast has assumed a regional corporate organizational structure.
As a result, management has selected several functions and processes to be executed under standardized methodologies and common procedures. Two of these efforts relate to establish-ing common processes relative to the Off-site and On-site Review Committees.
To maximize consistency within Entergy, ENN is modeling these committees' functions after those of Entergy Nuclear South (ENS) as established in the ENS QA Program and described in ENS Nuclear Management Manual Procedures.
With regard to the standard On-site Review Committee, there are no changes under the transition to a common process that impact Section 1 of the PQAM.
However, a change to this section has been made to support a concurrent Updated Final Safety Analysis Report (UFSAR) change. The commitment for this committee quorum to include a member or alternate with a Senior Reactor Operator license has been relocated to the Pilgrim QA Manual.
The changes relative to the Off-she Review Committee involve the transition from the PNPS Nuclear Safety Review and Audit Committee (NSRAC) to a corporately headquartered function responsive to the ENN fleet. The NSRAC, which reports to the Site Vice President, will be eliminated and replaced by the ENN corporate Off-site Safety Review Committee located at the White Plains, NY headquarters office. This committee reports to the Chief Operating Officer. Accordingly, the PQAM has been revised to address the revised name of this committee and its reporting chain to management.
To effect the transition to common functions, ENN Nuclear Management Manual Procedures OM-1 19, "On-Site Safety Review Committee," and QV-107, "Off-Site Page 2 of 2
Review Committee," have been developed to describe these committees and their functions.
These ENN Procedures are identical to ENS Procedures that implement the requirements and commitments of the ENS QA Manual. Several ENS QA Manual clarifications and exceptions relative to the Off-site and On-site Safety Review Committees' requirements contained in Regulatory Guide 1.33 or ANSI N1 8.7 require adoption. See PQAM Change Request 01-02.
The changes to Section 1 are administrative and have no adverse impact on the PQAM or its commitments. Accordingly, these changes are allowed to be made under 1 OCFR50.54(a)(3) without prior NRC approval.
Prepared by: z 2 ZzhZ101 nizant, En ne Date Approved by:
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Attachment D PQAM Section 16 PQAM Change Request No. 02-01 Please note that the change request refers to Attachments 1 and 2 that are not attached in this transmittal but are available for inspection.
RTYPE: A2.23 fteg PILGRIM NUCLEAR POWER STATION PILGRIM QUALITY ASSURANCE MANUAL (PQAM)
CHANGE REQUEST NO.
02-01
-SECTION 16 REV. NO.
0 PARAGRAPH NO.
All PAGE NO.
All REVISION (exact wording)
This section has been rewritten in its entirety; therefore, no revision bars are included in the new revision (PQAM Revision 0). See Attachment 1 for a markup of the existing BEQAM Revision 29 and refer to Attachment 2 for information I relative to the changes being made and the disposition of revised text.
PURPOSE OF REVISION To facilitate the adoption of the Entergy common QA Program under Entergy Nuclear Northeast initiatives, the existing section has been completely rewritten to provide a level of discussion consistent with that of the Entergy common QA Manual, which is written under a Standard Review Plan (SRP) 17.3 format.
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-6C EFFECTIVE DATE OF PQAM SECTION APPROVAL SIGNATURES 0IJUALITYASSURANCE MANAGER fae SITEVICE3 ate GENERAL MAAGER3D STEVICR8 T-V--
Dte GNRLMNGRDt
QA PROGRAM CHANGE EVALUATION PQAM Change Request No.
02-01 Section No.
16 Rev.
0 EVALUATION Does the above change to the QA Program reduce the commitments concerning:
Yes No L
Program coverage documentation (policies, procedures, or inspections)
U U Policy, procedure, or instruction compliance O K Identification of structure systems, and components U U Identification of major participating organizations and their designated func-tions O U Providing control over activities affecting the quality of the identified structures, systems, and components O
- Controlling conditions under which activities affecting quality are to be accom-plished (e.g., equipment, environmental conditions, prerequisites)
O U Attaining required quality (e.g., special controls, processes, test equipment, tools, or skills)
O U Verification of quality by inspection and test O U Providing indoctrination and training of personnel performing activities affecting quality O
- Regularly reviewing the status and adequacy of the QA Program U U Periodic review for status and adequacy by participating organization Manag-ers of the part of the QA Program which they are executing U El Other (explain) - none -
QA PROGRAM CHANGE EVALUATION (cont.)
POAM Change Request No.
02-01 CONCLUSION Section 16 of the Pilgrim Quality Assurance Program, as revised, continues to satisfy 10CFR50, Appendix B. The changes made within this section meet the criteria within 10CFR50.54(a)(3) relative to QA Program changes that can be made without prior NRC approval.
Under 10CFR50.54(a)(3), the changes made to rewrite this section in a manner to achieve consistency with the Entergy common QA Program description are allowed to be made without NRC approval. None of the changes represents a reduction of commitment previously stated in the QA manual.
DISCUSSION This revision to Section 16 is part of an overall effort to rewrite the entire program in a manner consistent with the Entergy common QA Program description, which is written under an SRP 17.3 format. These efforts are in support of an Entergy Nuclear Northeast initiative, which will eventually adopt the entire Entergy com-mon QA Manual for application at PNPS. It is important to note that the revision is significantly different than the existing section, which was written under an SRP 17.2 format.
SRP 17.2 addresses the criteria for an acceptable QA Program document using the 18 criteria format of 1 OCFR50, Appendix B. SRP 17.3 pres-ents an entirely different format addressing the criteria of 10CFR50, Appendix B within three primary program elements identified as Management, Perform-anceNerification, and Self-Assessment activities. SRP 17.3 addresses 1 OCFR50, Appendix B, Criterion 16, "Corrective Action," as it relates and applies to each of the three primary program elements. The end result is a program description that fully responds to 10CFR50, Appendix B criteria without unnecessary descriptive and/or implementing detail or text reiterative of criteria contained in Regulatory Guides and associated ANSI standards already committed to by the QA Program document. While the revision to PQAM Section 16 is written in a manner that effectively addresses SRP 17.3 review criteria, the existing 18-section 10CFR50, Appendix B format of the existing program is being maintained. The 18-section format of the PNPS QA Manual will be maintained until the Entergy common QA Program description is evaluated, determined acceptable for application to PNPS, and adopted under Entergy Nuclear Northeast initiatives.
CHANGE EVALUATION This revision of Section 16 entails a complete rewrite to describe the corrective action process using the verbiage contained in the Entergy common QA Program description. A marked-up copy of the existing Section 16 is provided in Attach-ment 1. The detailed evaluations of the changes made are documented in. Attachment 2 provides a verbatim copy of the existing Section 16 in a table form that documents a line-by-line evaluation of the QA program. This attachment identifies the disposition of text as compared to the proposed verbiage within the Entergy common QA Program and classifies text changes under 1 OCFR50.54(a)(3) criteria.
Where appropriate, reference to text within the Entergy common QA Program that corresponds to essential existing requirements and commitments being retained is provided.
As indicated in Attachment 2 via assignment of Text Change Codes and their cor-responding descriptions, none of the changes adversely impacts program respon-siveness to 10CFR50, Appendix B. While some of the changes are classified as Bless restrictive," they do not reduce existing program commitments pertinent to 10CFR50, Appendix B criteria.
From an overall perspective, this revision de-scribes existing Pilgrim corrective action control measures with a minimal level of detail. While non-essential descriptive text, implementing detail, and discussion relative to responsible functional groups have been deleted, the level of discus-sion in the proposed revision effectively addresses the requirements of Criterion 16 of 10CFR50, Appendix B and PNPS commitments to Regulatory Guide 1.33, including associated ANSI Standard N18.7 (ref. PQAM Section 2). via the assignment of 50.54(a)(3) Disposition Codes and their corre-sponding descriptions also identifies where each program change falls within the criteria of 10CFR50.54(a)(3). Program changes assigned Disposition Codes other than 54(a)(3)(ii) are allowed to be made under the regulation without prior NRC approval. Several of the changes to existing text fall within criteria specified in 1 OCFR50.54(a)(3)(ii). Under this regulation, these changes require the evaluated acceptance and application of a previous NRC Safety Evaluation Report in order for the change to be made without requiring prior NRC approval. These changes are determined to be acceptable based on the following:
54(a)(3)(11)1 Disposition Code Changes:
Implementing details are being deleted that support higher-level program requirements or commitments being retained in the revised program. The higher-level requirements and commit-ments are essential in providing a program description that adequately re-sponds to 1 OCFR50, Appendix B criteria. The deleted details are redundant to requirements within implementing procedures that are adequately controlled' under Sections 5 and 6 of the QA Program. The program controls in Sections 5 and 6 ensure these implementing procedures adequately address and effectively support the higher-level program requirements controlled under 10CFR50.54(a).
- 54(a)(3)(i)-2 Disposition Code Changes: To achieve consistency with the Entergy common QA Manual, descriptive details and/or functional responsibili-ties pertaining to essential QA Program requirements or commitments retained within the QA Program have been summarily addressed by generic verbiage.
The revised text continues to address 1 OCFR50, Appendix B criteria satisfacto-
rily through generically stated requirements and organizational arrangements, as well as retaining specific commitments to Regulatory Guide No. 1.33 and associated ANSI Standard N18.7.
NRC Safety Evaluation Report TAC M97893, which approves the common Entergy QA Program document submitted by Entergy Nuclear South (ENS), has been evaluated and found acceptable for application at PNPS. Within the ENS submittal, the deletion of implementing details and/or the replacement of specific process criteria and functional responsibilities from the individual QA Programs of the ENS plants with generically worded text in the common QA Program descrip-tion was identified as being less restrictive. These text modifications and/or dele-tions were accepted by the NRC on the basis that the new and more generically stated common QA Program continues to satisfy the requirements of 10CFR50, Appendix B (ref. SER Section 3.0, "Format of Presentation," and Section 4.6, Corrective Action"). The elimination of implementing detail relative to the PNPS corrective action process and the generic stating of program requirements are consistent in nature and scope to the program changes made by the ENS plants.
The text within the proposed revision to PQAM Section 16 is also verbatim of the text within the ENS common QA Manual relative to the corrective action process.
Accordingly, the bases of the NRC's approval of the common Entergy QA Pro-gram is considered acceptable for application at PNPS.
There is no adverse program effect. The elimination of implementing detail and the generic stating of program requirements via the adoption of pertinent Entergy common QA Program text is acceptable without prior NRC approval, as pre-scribed in 10CFR50.54(a)(3)(ii).
Prepared by:
Approved by:
7f tJr 1J(;14.-4 Dae
-oZ QA Marg er Date Owdsesi~lnt laMnger Date
Attachment E PQAM All Sections PQAM Change Request No. 02-02 Please note that the change request refers to the PQAM Evaluation Package that documents the evaluation for adoption of the entire Entergy QA Program. The PQAM Evaluation Package is not included in this transmittal but is available for inspection.
The replacement pages for the PQAM were filed on the Pilgrim Nuclear Power Station docket under NRC TAC # ML021280592 date 04/27/02 and accordingly, the replacement pages are not included within this attachment.
RTYPE: A2.23 PILGRIM NUCLEAR POWER STATION PILGRIM QUALITY ASSURANCE MANUAL (PQAM)
CHANGE REQUEST NO.
02-02 SECTION All REV. NO.
Various PARAGRAPH NO.
All PAGE NO.
All REVISION (exact wording)
The existing Pilgrim QA program description is being replaced through the adoption of the common Entergy Quality Assurance Program Manual (QAPM) for application at the Station. The adoption represents a rewriting of the entire PNPS QA program description under a completely different format.
PURPOSE OF REVISION This effort has been undertaken by PNPS, as well as the other Entergy Nuclear Northeast (ENN) plants, in order to transition to a QA program document that serves as the common QA program description for the entire Entergy fleet of nuclear plants.
-0fIN z
'Date EFFECTIVE DATE OF CHANGE REQUEST APPROVAL SIGNATURES Asolo L Q AI ASS RANCE MANAGER Date
_)
HE VICE PRES DENT Date GENERAL MAt S 'b -=
JAGER
QA PROGRAM CHANGE EVALUATION POAM Change Request No.
02-02 Section No.
All Rev.
Various EVALUATION Does the above change to the QA Program reduce the commitments concerning:
Yes No O U 1 OCFR50, Appendix B o
v Program coverage documentation (policies, procedures, or inspections)
O a Policy, procedure, or instruction compliance O U Identification of structure systems, and components O U Identification of major participating organizations and their designated func-tions O K Providing control over activities affecting the quality of the identified structures, systems, and components o
U Controlling conditions under which activities affecting quality are to be accom-plished (e.g., equipment, environmental conditions, prerequisites)
O U Attaining required quality (e.g., special controls, processes, test equipment, tools, or skills)
O U Verification of quality by inspection and test o
U Providing indoctrination and training of personnel performing activities affecting quality O U Regularly reviewing the status and adequacy of the QA Program O U Periodic review for status and adequacy by participating organization Manag-ers of the part of the QA Program which they are executing O E Other (explain) -none
QA PROGRAM CHANGE EVALUATION (cont.)
PQAM Change Request No.
02-02 CONCLUSION The Pilgrim Quality Assurance Program, as revised through the adoption of the common Entergy Quality Assurance Program Manual.(QAPM), continues to satisfy 10CFR50, Appendix B. The changes made to the existing QA program description satisfy the criteria within 10CFR50.54(a)(3) relative to QA program changes that can be made without prior NRC approval.
DISCUSSION The adoption of the common Entergy Quality Assurance Program Manual (QAPM) represents a rewriting of the entire PNPS QA program description under a completely different format. This effort has been undertaken by PNPS, as well as the other Entergy Nuclear Northeast (ENN) plants in order to transition to a QA program document that serves as the common QA program description for the entire Entergy fleet of nuclear plants.
It is important to note that the adopted program is significantly different than the existing Pilgrim QA Manual (PQAM), which was written under an SRP 17.2 format.
SRP 17.2 addresses the criteria for an acceptable QA program document using the 18 Criteria format of 10CFR50, Appendix B. SRP 17.3 presents an entirely different format, addressing the criteria of 1 OCFR50, Appendix B within three primary program elements identified as Management, PerformanceNerification, and Self-assessment activities. The end results-is a program description that fully responds to 1 OCFR50, Appendix B criteria without unnecessary descriptive and/or implementing detail or text reiterative of criteria contained in Regulatory Guides and associated ANSI Standards already committed to by the QA program document.
CHANGE EVALUATION As demonstrated by the documents contained within the Pilgrim QA Manual Evaluation Package developed under the ENN Common QA Program Manual Project, a comprehensive line-by-line review of the QA program, as compared to the common Entergy QA Program Manual, has been performed. This review has identified all changes to present QA program requirements and commitments experienced through the adoption of the common Entergy QA Program Manual.
Each change has been evaluated to determine the:
- Sustained adequacy of the program relative to the criteria of 10CFR50, Appendix B.
Impact of text modifications and/or deletions on previously established pro-gram scope and requirements, as well as the need to disposition significant changes in a manner that precludes reduction in QA program commitments.
Impact of revised commitments or new alternatives to regulatory guidance realized by the adoption of the common Entergy QA Program Manual.
- Acceptability of less restrictive changes to existing requirements, as well as the assumption of less restrictive Entergy common QA program allowances under 1 OCFR50.54(a)(3).
Need for revised process and procedure controls to administer the program changes effectively.
The Pilgrim QA Manual Evaluation was performed in two phases. Phase I identi-fies and evaluates the changes to the existing PQAM text. Phase II identifies and evaluates the changes realized by the assumption of commitments to later edi-tions of Regulatory Guides and the associated alternatives to this guidance that are not addressed within the existing Pilgrim QA program description.
Phase I Review The Phase I review is documented in the QA Program Matrices and the Detailed Evaluation Forms contained under Tab 8 of the PQAM Evaluation Package. The matrices provide a verbatim copy of the existing PQAM Sections in a table form and document a line-by-line evaluation of the QA program. These matrices iden-tify the changes made, their classification as being uAdministrative" or "Less Restrictive,"
and document the disposition of the change relative to 10CFR50.54(a) criteria. Where appropriate, reference to text within the Entergy common QA program that corresponds to existing requirement and commitments being retained is provided. Where text is deleted as being reiterative of ANSI Standard requirements, reference to the applicable Standard and its correspond-ing requirement is identified.
From an overall perspective, the majority of changes have been made to: reflect the sale of PNPS to Entergy, the resultant changes in organizational structure, the elimination of descriptive and implementing detail not necessary under an SRP 17.3 format, and the deletion of requirements that are reiterative of criteria within Regulatory Guides and ANSI Standards already committed to by the common QA program document.
As indicated in these matrices via assignment of Text Change Codes and their corresponding descriptions, none of the changes ad-versely impacts program responsiveness to 10CFR50, Appendix B. While some of the changes are classified as 'less restrictive," they do not reduce program adequacy relative to 10CFR5O, Appendix B criteria.
These matrices, via the assignment of 50.54(a)(3) Disposition Codes and their corresponding descriptions, also identify where each program changes falls within the criteria of 10CFR50.54(a)(3). Program changes assigned Disposition Codes other than 54(a)(3)(ii) are allowed to be made under the regulation without prior
NRC approval. Changes assigned the 54(a)(3)(ii) Disposition Code can also be made without prior NRC approval provided a previous NRC Safety Evaluation Report (SER) is evaluated, determined applicable to the change being made, and found acceptable for use under the criteria of the regulation. As indicated by the descriptions to the 54(a)(3)(i) Disposition Codes assigned, all changes are acceptable based on the evaluated application of the NRC Safety Evaluation Reports associated with the common QA program submittals by Entergy Nuclear South (ENS) (reference NRC TAC M9783) and/or First Energy Nuclear Operating Company (reference NRC TAC MB0914 and MB0915).
Where the changes identified, during the Phase I review are considered to be more significant due to the sensitivity of the subject matter involved, more detailed evaluations have also been performed. These more significant issues and their evaluations are documented in Detailed Evaluation Forms PNPS-1 through PNPS-10 contained under Tab 8S in the PQAM Evaluation Package. None of these more significant program changes was concluded to have an adverse pro-gram effect relative to 10CFR5O, Appendix B criteria. These changes were also
-determined under the criteria of 10CFR50.54(a)(3) to be acceptable without re-quiring prior NRC approval.
In support of the final adoption of the common Entergy QA Program Manual, several existing PQAM commitments are required to be relocated to the PNPS Updated Final Safety Analysis Report (UFSAR). The required actions are identi-fied in the listing of Phase I Action Items under Tab 1 OA of the PQAM Evaluation Package.
Phase 11 Review The Phase II review is captured within the documents contained under Tab 9 to the PQAM Evaluation Package. This review identifies the changes to existing regulatory guidance commitments due to the adoption of the common Entergy QA Program Manual. These changes include:
- The elimination of referenced commitments to two Regulatory Guides and one ANSI Standard.
Revised commitment to later editions of two Regulatory Guides.
- The introduction of new alternatives (exceptions and clarifications) to regula-tory guidance specified in the common Entergy QA Program Manual The elimination of referenced commitments to Regulatory Guides 1.54 and 1.55 and ANSI Standard N45.2.16 has been reconciled through the relocation of these commitments to appropriate sections of the PNPS UFSAR to preclude reduction in program commitments.
The evaluation of revised commitments to later editions of Regulatory Guides 1.64 and 1.74 has concluded these changes to be acceptable under 10CFR50.54(a)(3)(v) without requiring revisions to established process and pro-cedures controls.
9
The new alternatives to regulatory guidance commitments have also been found acceptable, as indicated by the assessment documented in Detailed Change Evaluation Form PNPS-1 1. These changes have been Collectively and conserva-tively considered as less restrictive alternatives and evaluated as having no ad-verse program effect based on the NRC's previous approval of these alternatives during the Entergy Nuclear South submittal of the common QA Program Manual.
As such, these less restrictive changes are allowed to be applied at PNPS without prior NRC approval under the allowance of 1 OCFR50.54(a)(3).
The Phase 11 review has also disclosed that the manner in which these altema-tives are presented in the common Entergy QA Program Manual requires several process and procedure revisions to be instituted at the time the manual is made effective at PNPS. These issues are identified in the Phase II Action Item List contained under Tab I OB of the POAM Evaluation Package. Each of these items has been referred to the responsible functional area group for further review and to revise procedures, as necessary, in support of the adoption of the common Entergy QA Program Manual.
All changes to the Pilgrim QA program description realized from the adoption of the common Entergy QA Program Manual are concluded to be acceptable in that the adequacy of the program at PNPS relative to license requirements and com-mitments has been maintained. As evidenced by the detailed evaluations per-formed, these changes can also be made without prior NRC approval based on the allowances of 10CFR50.54(a).
)
Prepared by:
Approved by:
ahager Date
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