ULNRC-06539, Operating Quality Assurance Manual, Revision 34

Operating Quality Assurance Manual, Revision 34

ML19302G424
Person / Time
Site:	Callaway
Issue date:	10/24/2019
From:	Diya F Ameren Missouri, Union Electric Co
To:	Document Control Desk, Office of Nuclear Material Safety and Safeguards, Office of Nuclear Reactor Regulation
Shared Package
ML19302G421	List: ML19302G427 ML19302G428 ULNRC-06539, Operating Quality Assurance Manual, Revision 34
References
ULNRC-06539
Download: ML19302G424 (15)

Text

rAiIieiefl Callaway Plant MISSOURI October24,2019 .

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ULNRC-06539 U. S. Nuclear Regulatory Commission Attn: Document Control Desk Washington, DC 20555-000 1 10 CFR 50.54 10 CFR 50.71 Ladies and Gentlemen:

DOCKET NUMBER 50-483 and 72-1045 CALLAWAY PLANT UNIT 1 UNION ELECTRIC Co.

RENEWED FACILITY OPERATING LICENSE NPF-30 Operating Quality Assurance Manual (OQAM) Revi sion 34

References:

1 Ameren Missouri Letter ULNRC-06443, Operatin g Quality Assurance Manual (OQAM)

Revision 33, dated June 1 1 2018 Furnished herewith is OQAM Revision 34. Pursuant to the requirements of 10 CFR 50.54 and 10 CFR 50.71, the OQAM has been revised to incorpora te changes since the last docketed revision transmitted via Reference 1.

The following are provided as attachments to this letter:

1 Description and Justification for Proposed Changes to the OQAM

2. OQAM Revision 33a mark-up, identifying changes through the use of strikeovers and inserts

3. Updated pages which constitute OQAM Revision 34 z ::::::;::::;;:::.::

E $315 County Road 459 Steedman, MO 65077 AmerenMissouri.com

ULNRC-06539 10/24/2019 Page2of5 Revision 34 incorporates OQAM Change Notices (CNs)19-001, 19-002 and 19-003. The changes in this revision include:

. Clarification ofthe requirements for reviews of 1 0 CFR 72.48 evaluations by the Onsite Review Committee (ORC) associated with the Callaway Energy Center (CEC) Independent Spent fuel Storage Installation (ISFSI) and associated Dry Cask Storage System (DCSS).

. Removal ofthe responsibility for the Regulatory Affairs department to provide distribution of controlled documents at Amerens General Office Building in St. Louis, MO.

. Expansion ofthe use of the International Laboratory Accred itation Cooperation (ILAC) Mutual Recognition Arrangement (MRA) process to laboratories accredited to both ISO/IEC 17025:2005 and ISO/IEC 17025:2017 based on USNRC letter dated April 16, 2019 (ADAMS Accession # ML19056A451).

The CNs were reviewed internally and determined to not represent reductions in commitment to the Operating Quality Assurance Program as previously accept ed by the NRC. The OQAM continues to maintain its focus on activities affecting quality, consistent with importance to safety, including compliance with I 0 CFR 50 Appendix B requirements.

If there are any questions, please contact Hrach Minassian, Nuclear Oversight Audit Supervisor, at 573-220-9213.

I declare under penalty of perjury that the foregoing is true and correct.

Sincerely F. M. Diya Senior Vice President and Chief Nuclear Officer Executed on:

HKM/DER/mls Attachments:

1) Description and Justification for Proposed Changes

2) OQAM Revision 33a mark-up, identifying changes throug h the use of strikeovers and inserts

3) Updated pages which constitute OQAM Revision 34

ULNRC-06539 10/24/2019 Page3of5 cc: Mr. Scott A. Morris Regional Administrator U. S. Nuclear Regulatory Commission Region IV 1600 East Lamar Boulevard Arlington, TX 76011-4511 Director Division of Spent Fuel Management Office ofNuclear Material Safety and Safeguards U. S. Nuclear Regulatory Commission Washington, DC 20555-0001 Senior Resident Inspector Callaway Resident Office U.S. Nuclear Regulatory Commission 8201 NRC Road Steedman, MO 65077 Mr. L. John lUos Project Manager, Callaway Plant Office ofNuclear Reactor Regulation U. S. Nuclear Regulatory Commission Mail Stop O9E3 Washington, DC 20555-0001

ULNRC-0653 9 10/24/2019 Page4of5 Index and send hardcopy to QA File A160.0761 Hardcopy:

Certrec Corporation 6100 Western Place, Suite 1050 FortWorth,TX 76107 (Certrec receives ALL attachments as long as they are non-sa feguards and may be publicly disclosed.)

Electronic distribution for the following can be made via QA Program ULNRC Distribution:

F. M. Diya T. E. Hermiann B. L. Cox S. G. Kovaleski R. C. Wink T. B. Elwood NSRB Secretary STARS Regulatory Affairs Mr. Jay Silberg (Pillsbury Winthrop Shaw Pittrnan LLP)

Mr. Dan Beck (Missouri Public Service Commission)

ULNRC-0653 9 10/24/2019 Page 5 of 5 LIST OF COMMITMENTS The following table identifies those actions committed to by Arnere n Missouri in this document. Any other statements in this document are provided for information purpos es and are not considered commitments.

LNone COMMITMENT Due Date/Event COMN to ULNRC-0653 9 OPERATING QUALITY ASSURANCE MANUAL (OQAM) REVISION 34 DESCRIPTION AND JUSTIFICATION FOR CHANGES The descriptions andjustifications listed below for OQAMCNs19-001, 19-002 and 19-003 refer to OQAM changes as indicated by the marked-up pages of interim Revision 33a provided in . The OQAMCNs were previously reviewed internally, and the OQAM continues to comply with the requirements of 10 CFR 50 Appendix B. None ofthe changes to the approved Quality Assurance Program were determined to constitute a reduction in commitment in accordance with 10 CFR 50.54(a)(3). The basis for the conclusion that these changes did not constitute a reduction in commitment is provided in the change descriptions below. Lastly, a table of editorial changes is provided for completeness. These changes do not constitute a reduction in commitment as provided in 10 CFR 50.54(a)(3).

OQAMCN 19-001 These changes resolved confusion regarding ORC review of 10 CfR 72.4$ evaluations performed by Holtec, Inc. for changes to their Dry Cask Storage System (DCSS) I hidependent Spent Fuel Storage Installation (ISFSI) design covered by their Certificate of Compliance (CoC) that are un-related to Callaways DCSS/ISFSI. Callaways ORC does not provide review of Holtecs 10 CFR 72.4$ evaluations unless they also affect Callaways DCSS and 1SF SI installation.

These changes eliminated sentences in OQAM section 3 1 5 that were redundant to requirements in OQAM section 1.7 and/or 10 CFR 50.59 and 10 CFR 72.4$ regulatory requirements. This change also modified OQAM section 3 19 to remove a sentence that was redundant to the requirements established in OQAM section 1 .7; removed prescriptive content that was redundant to the sentences above it and to content in OQAM section 3 1 5; and removed a sentence that is not correct regarding Amerens approval of outside organizations design documents and 10 CFR 50.59 and 10 CFR 72.4$ evaluations. This sentence was in conflict with other OQAM sections and the 10 CFR 72.212 requirements for general licensees ofISFSIs. Lastly, a footnote was added to OQAM section 1 .7.6 to indicate that the Certificate of Compliance (CoC) holder for the ISFSI performs 10 CFR 72.4$ evaluations not subject to review and approval by the CEC Onsite Review Committee (ORC).

The OQAM issues arose during the licensing activities for CECs ISFSI and DCSS when something akin to a find and replace approach was used to add reference to 10 CFR 72.4$

wherever 10 CFR 50.59 showed up in the OQAM. While generally an acceptable practice, in some places this resulted in overly broad requirements.

These changes are considered editorial clarifications and are consistent with existing OQAM sections, OQAM Appendix B, 10 CFR 50 Appendix B, and 10 CFR 72.212(b) requirements.

Page 1 of 10 to ULNRC-06539 OQAM section Current description Revised Description Justification 1.7.6 The ORC shall be The ORC shall be responsible for: responsible for:

a) Deleted. a) Deleted.

b) Review of b) Review of 10CFR5O.59 and 10CFR5O.59 and 1 0CFR72.48 1 0CfR72.48 Added footnote 6 to evaluations evaluations6 b),c)andd)to regarding: regarding: reconcile the CEC OQAM scope for

. procedures, . procedures, review of

. changes to changes to 1 OCFR72 .48 procedures, procedures, evaluations with the equipment, systems equipment, systems requirements of or facilities, and or facilities, and 10CFR72.2 12(b)(5)

. tests or experiments . tests or experiments thru (8).

completed under the completed under the provision of provision of 10CFR5O.59 and 10CFR5O.59 and 10CFR72.48 to 10CFR72.48 to verify that such verify that such actions did not actions did not require prior NRC require prior NRC approval. approval.

c) Review of proposed c) Review of proposed procedures and procedures and changes to changes to procedures, procedures, equipment, systems equipment, systems or facilities which or facilities which may involve prior may involve prior NRC approval as NRC approval as defined in defined in 10CFR5O.59 and 10CFR5O.59 and 1 OCFR72.48; 1 OCFR72.486; d) Review of proposed d) Review of proposed test or experiments test or experiments which may involve which may involve prior NRC approval prior NRC approval as defined in as defined in 10CFR5O.59 and 10CFR5O.59 and 1 OCFR72.48; 1 OCFR72.486; e) Review of proposed e) Review of proposed Page2oflO to ULNRC-06539 OQAM section Current description Revised Description Justification changes to Technical changes to Technical Specifications or Specifications or Operating License; Operating License; f) Investigation of all 0 Investigation of all violations of the violations of the Technical Technical Specifications Specifications including the including the forwarding of reports forwarding of reports covering evaluation covering evaluation and and recommendations to recommendations to prevent recurrence to prevent recurrence to the Senior Vice the Senior Vice President and Chief President and Chief Nuclear Officer. Nuclear Officer.

g) Review of report of g) Review ofreport of operating operating abnormalities, abnormalities, deviations from deviations from expected expected performance of plant performance of plant equipment and of equipment and of unanticipated unanticipated deficiencies in the deficiencies in the design or operation design or operation of structures, of structures, systems or systems or components that components that affect nuclear safety; affect nuclear safety; h) Review of all h) Review of all REPORTABLE REPORTABLE EVENTS; EVENTS; i) Review ofthe plant i) Review ofthe plant Security Plan; Security Plan; j) Review of the j) Review of the Radiological Radiological Emergency Emergency Response Plan Response Plan k) Review of changes k) Review of changes to the PROCESS to the PROCESS CONTROL CONTROL Page3 oflO to ULNRC-0653 9 OQAM section Current description Revised Description Justification PROGRAM, the PROGRAM, the OFFSITE DOSE OFFSITE DOSE CALCULATION CALCULATION MANUAL, and MANUAL, and Radwaste Treatment Radwaste Treatment Systems; Systems;

1) Review of any 1) Review of any accidental, accidental, unplanned or unplanned or uncontrolled uncontrolled radioactive release radioactive release including the including the preparation of preparation of reports covering reports covering evaluation, evaluation, recommendations, recommendations, and disposition of and disposition of the corrective action the corrective action to prevent recurrence to prevent recurrence and the forwarding and the forwarding ofthese reports to ofthese reports to the Senior Director, the Senior Director, Nuclear Operations. Nuclear Operations.

m) Review of Unit m) Review of Unit operations to detect operations to detect potential hazards to potential hazards to nuclear safety; nuclear safety; n) Investigations or n) Investigations or analysis of special analysis of special subjects as requested subjects as requested by the Senior Vice by the Senior Vice President and Chief President and Chief Nuclear Officer. Nuclear Officer.

o) Review of Unit o) Review of Unit Turbine Overspeed Turbine Overspeed Protection Protection Reliability Program Reliability Program and revisions and revisions thereto; thereto; p) Review ofthe Fire p) Review of the Fire Protection Program. Protection Program.

Page4oflO to ULNRC-06539 OQAM section Current description Revised Description Justification added footnote 6.

Consistent with Added footnote 6 to 10CFR72.210 and the reconcile the CEC requirements of OQAM scope for 10CFR72.212(b)(5) through review of (b)(8), 10CFR72.48 10CFR72.48 evaluations performed by evaluations with the the CoC holder under their requirements of quality program do not OCFR72 .2 1 2(b)(5) require ORC review. thru (8).

3 18

. Independent of the Independent of the responsibilities ofthe responsibilities of the design organization, the design organization, the requirements of the Onsite requirements of the Onsite Review Committee (ORC) Review Committee (ORC) as defined in OQAM as defined in OQAM Section 1 .0 shall be Section 1 .0 shall be satisfied. satisfied.

Safety Related Design Safety Related Design changes shall be reviewed changes shall be reviewed The change deletes by the ORC and approved by the ORC and approved a sentence because it 5 duplicative of by the Senior Director, by the Senior Director, Nuclear Operations. In Nuclear Operations. li the requirements in addition, addition, OQAM Section designlconfiguration designiconfiguration 1 .7.6 items b), c) changes that require a changes that require a and d). In addition, change in the Callaway change in the Callaway 10CFR5O.59 and Plant Technical Plant Technical 10CFR72.48 define Specifications, a License Specifications, a License the requirements for Amendment per Amendment per a license 10CFR5O.59, or an NRC 10CFR5O.59, or an NRC amendment and or CoC Amendment per CoC Amendment per CoC revision. The 10CFR72.48 require 10CFR72.48 require removal of the review by the ORC. (NRC review by the ORC. (NRC duplicate content is approval of the License approval of the License considered an Amendment is required Amendment is required editorial change that prior to implementation of prior to implementation of does not lessen the CEC OQAM requirements.

Page5 oflO to ULNRC-06539 OQAM section Current description Revised Description Justification the designlconfiguration the designlconfiguration change.). change.).

When design is performed When design is performed by an outside organization, by an outside organization, Ameren Missouri shall Ameren Missouri shall perform or coordinate a perform or coordinate a review ofthe design for review ofthe design for operability, maintainability, operability, maintainability, inspectability, FSAR inspectability, FSAR commitment compatibility, commitment compatibility, test and inspection test and inspection acceptance criteria acceptance criteria acceptability, and design acceptability, and design requirements imposed by requirements imposed by Plant generating Plant generating equipment. equipment.

3.19 10CFR5O.59and 10CFR5O.59 and 10CFR72.48 evaluations, 10CFR72.48 evaluations, which consider the effect of which consider the effect of the design as described in the design as described in the design documents, shall the design documents, shall This first proposed be performed by the be performed by the change deletes a responsible Ameren responsible Ameren sentence because:

Missouri engineering Missouri engineering 1) it is duplicative organization or outside organization or outside of the requirements organization(s). These organization(s). These in OQAM Section evaluations shall include the evaluations shall include the 1 .7.6 items b), c) basis for the determination basis for the determination and d), and 2) that the designlconfiguration that the design/configuration because the scope of change does not involve change does not involve 72.4$ evaluations prior NRC approval via a prior NRC approval via a subject to CEC License Amendment or CoC License Amendment or CoC ORC review is Amendment. As deemed Amendment. As deemed established by necessary by the evaluating necessary by the evaluating 10CFR72.2 12(b)(5) organization, detailed organization, detailed through (8). The analyses shall be performed analyses shall be performed removal of the to support the bases of to support the bases of duplicate sentence is 10CFR5O.59 and 10CFR5O.59 and considered an 10CFR72.48 evaluations. 10CfR72.4$ evaluations. editorial change that All 10CFR5O.59 and All 10CFR5O.59 and does not lessen the 10CFR72.48 evaluations are 10CFR72.48 evaluations are CEC OQAM submitted to the ORC. submitted to the ORC. requirements.

Changes involving the Changes involving the Page6oflO to ULNRC-0653 9 OQAM section Current description Revised Description Justification substitution of equivalent substitution of equivalent hardware require the hardware require the 10CFR5O.59 and 10CFR5O.59 and 10CfR72.48 process (in 10CFR72.48 process (in addition to the appropriate addition to the appropriate requirements of this OQAM) requirements of this OQAM) The second and to assure that the design to assure that the design third proposed requirement changes are requirement changes are change deletes consistent with and do not consistent with and do not duplicate alter the design criteria alter the design criteria requirements from specified in existing design specified in existing design other OQAM documents. When an documents. When an sections. The outside organization outside organization requirements for the performs the 1OCfR5O.59 performs the 10CFR5O.59 reviews of and 10CFR72.48 process or and 10CFR72.48 process or 10 CFR 50.59 and prepares design documents prepares design documents 10 CFR 72.48 under its QA program, under its QA program, evaluations are review and approval per review and approval per given in OQAM ANSI N45.2.1 1 will be ANSI N45.2.1 1 will be Sections 1.7.6 and included. Ameren Missouri included. Ameren Missouri 3 1 8, and the will approve all outside will approve all outside requirements for organizations design organizations design design reviews documents and 10CFR5O.59 documents and 10CFR5O.59 associated with the and 10CFR72.48 and 10CFR72.48 DC$S/ISFSI is evaluations, and will evaluations, and will given in OQAM perform appropriate reviews perform appropriate reviews Appendix B necessary for final approval. necessary for final approval. Section 3.1.

OQAMCN 19-002 Reference to the Regulatory Affairs department having responsibility for distribution of controlled documents at Amerens General Office Building (GOB) located in St. Louis, Missouri and for transmittal of documents to the Administration department located at the Callaway Energy Center (CEC) for entry into the document control system have been deleted. This was a function of the Regulatory Affairs department prior to their relocation to the CEC plant site in the mid-2000s. Today, very few CEC-related functions are performed at the GOB and, for those that are, they interface with the Administration department for the control of documents. This change is viewed as an organizational change and consolidation of an existing function already assigned to the Administration department and, therefore, does not constitute a reduction in commitment.

Page7oflO

Attachment 1 to ULNRC-0653 9 QAP element or OQAM section Current description Revised Description Justification 6.7 The issuance of The Administration Regulatory Affairs no controlled documents at organization shall be longer maintains a staff the General Office and responsible for assuring presence at the GOB, so Callaway Plant is the issuance of controlled there is no longer any coordinated by the documents at the Plant need to issue documents Regulatory Affairs and Site. there or to transmit the Administration documents from the organizations. The GOB to Administration.

Administration This change is an organization shall be organizational revision responsible for assuring that may be the issuance of implemented without controlled documents at prior NRC approval per the Plant Site. 10 CFR 50.54(a)(3)(vi).

Regulatory Affairs shall be responsible for assuring the issuance of controlled documents at the General Office, and for transmittal of documents to the Administration organization for entry into the document control system.

OQAMCN 19-003 This change expands the use of the ILAC Process to laboratories accredited to both ISO/IEC 17025:2005 and ISO/IEC 17025:2017 based on USNRC letter dated April 16, 2019 (ADAMS Accession # ML19056A451). The ILAC Process allows the use ofcalibration and testing laboratories during the commercial grade dedication process based on the laboratorys accreditation to ANSIIISO/IEC 17025 by accreditation bodies that are signatories to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA). The NRC recently expanded their acceptance of accreditations to ANSI/ISO/IEC 17025:2005 to include ISO/IEC 17025:2017 during the transition period that ends on November 30, 2020 after which continued use ofthe process will require a revision to NET 14-05A, Guidelines for the Use of Accreditation In Lieu of Commercial Grade Surveys for Procurement of Laboratory Calibration and Test Services.

Page$oflO to ULNRC-06539 OQAM section Current description Revised Description Justification 4.9.la, These sections The revised wording The NRC Provisional 4.9.2a, and currently specify includes both ISO/IEC letter dated April 1, 4.9.3a ISO/IEC 17025:2005 17025:2005 and ISO/IEC 2019 recognizes both 17025:2017 ISO/IEC 17025:2005 and ISO/IEC 17025:20 17.

7.16.1.la and These sections The revised wording The NRC Provisional

7. 1 6. 1 .2a currently specify includes both ISO/IEC letter dated April 1, ISO/IEC 17025:2005 17025:2005 and ISO/IEC 2019 recognizes both 17025:2017 ISO/IEC 17025:2005 and ISO/IEC 17025:2017.

1 8 10. 1 la

. . These sections The revised wording The NRC Provisional and currently specify includes both ISO/IEC letter dated April 1, 12.10.1.2a ISO/JEC 17025:2005 17025:2005 and ISO/IEC 2019 recognizes both 17025:2017 ISO/IEC 17025:2005 and ISO/IEC 17025:20 17.

Appendix A These sections The revised wording The NRC Provisional for currently specify includes both ISO/IEC letter dated April 1, Regulatory ISO/IEC 17025:2005 17025:2005 and ISO/IEC 2019 recognizes both Guide 1.123 17025:2017 ISO/IEC 17025:2005 and ISO/IEC 17025:2017.

Appendix A These sections The revised wording The NRC Provisional for currently specify includes both ISO/IEC letter dated April 1, Regulatory ISO/IEC 17025:2005 17025:2005 and ISO/IEC 2019 recognizes both Guide 1.144 17025:2017 ISO/IEC 17025:2005 and ISO/IEC 17025:2017.

EDITORIAL CHANGES The following editorial changes were reflected in Revision 34. By their nature, they were determined to not constitute a reduction in commitment as described in 10 CFR 50.54(a).

OQAM section Change made OQAP Moved the reference to footnote 1 to the end of the sentence. Added a note Policy / that Ameren Missouri now refers to Callaway Plant Unit 1 [e.g. the name on Introduction the licensing Docket] as the Callaway Energy Center (CEC). In the last paragraph, changed Ameren personnel to just personnel to eliminate any potential confusion regarding to whom the OQAP applies.

Page9ofl0 to ULNRC-06539 OQAM section Change made 1 1

. - Added footnote 2 in section 1 1 that Ameren Missouri now refers to Callaway Plant Unit 1 [e.g. the name on the licensing Docket] as the Callaway Energy Center (CEC).

-Added note that footnote 3 was not used. This was done to leave footnote 4 as is.

Reviewer Note: footnotes 2 and 3 have not been present in the OQAM for many years. These changes help address their absence while preserving the existing numbering sequence in the OQAM.

1.8 Deleted placeholders remaining after implementation ofOQAM CN 17-002 and CN 17-003 from interim revision 32b 2.6 underlined item 4) for formatting consistency 5 .3 1

. Allowed section to break across the page for readability 6.2 Changed the footnote number from 1 to 7 to preserve the consecutive numbering scheme for footnotes.

17.7 Changed the footnote number from 2 to 8 to preserve the consecutive numbering scheme for footnotes.

4.9, 5.10, Changed the indent depth on sub items for readability and formatting 7.6, 7.16.1, consistency 7.20, 15.5, 17.4, 18.8.1, 18.8.2, 18.10.1, 18.15.1 Section 1 2,

, - At numerous locations, changed Callaway Plant to Callaway Energy Center 5, 6, 10, 1 1 , or CEC at those locations where the context was referring to the name of the 12, 13, 14, facility. Callaway Plant was retained where the Operating License, Technical 15, 17 and Specifications, or other license basis document was specifically referenced.

18 Appendix A - At multiple locations, changed Callaway Plant to Callaway Energy Center or CEC at those locations where the context was referring to the name of the facility. Callaway Plant was retained where the Operating License, Technical Specifications, or other license basis document was specifically referenced.

Spacing was added to better identify section breaks between the Regulatory Guides to improve readability.

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