Text

Operating Quality Assurance Manual (Oqam) Revision 31, Oqam Change Notice 15-002
	ML15280A447
Person / Time
Site:	Callaway
Issue date:	10/07/2015
From:	Diya F; Ameren Missouri, Union Electric Co
To:	; Document Control Desk, Office of Nuclear Material Safety and Safeguards, Office of Nuclear Reactor Regulation
References
	ULNRC-06254
	Download: ML15280A447 (24)
	v • d • e

Fadi M. Diya Senior Vice President and Chief Nuclear Officer Ameren Missouri 4Aiiieren MISSOURI Callaway Energy Center F 573.676.4056 fdiya@ameren.com October 7, 2015 ULNRC-06254 U. S. Nuclear Regulatory Commission Attn: Document Control Desk Washington, DC 20555-000 1 10 CFR 50.54(a)

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) REVISION 31, OQAM CHANGE NOTICE 15-002

Reference:

NRC SER dated february 9, 2015, final Safety Evaluation Report for Technical Report NET 14-05, Guidelines for the Use of Accreditation in Lieu of Commercial Grade Surveys for Procurement of Laboratory Calibration and Test Services, Revision 1.

(ADAMS Accession No. ML14322A535)

Pursuant to 10 CFR 50.54(a)(4), Ameren Missouri (Union Electric Company) herewith transmits a request to approve a change to the Operating Quality Assurance Program (OQAP) as described in the Operating Quality Assurance Manual (OQAM) for the Callaway Plant. The proposed change is deemed to constitute a reduction in commitment. OQAM Change Notice (OQAMCN)15-002 incorporates a QA program alternative which was approved by the NRC through the NRCs final Safety Evaluation for Technical Report NET 14-05, Guidelines for the Use of Accreditation in Lieu of Commercial Grade Surveys for Procurement of Laboratory Calibration and Test Services, Revision 1.

While the SER approves the use of the International Laboratory Accreditation Cooperation (ILAC) accreditation process outlined in NEI 14-05A, the Applicability Section of the SER indicated that for licensees, use of the ILAC accreditation process in lieu of performing a commercial grade survey represents a reduction in commitment to the previously accepted QA program.

As a result, the NRCs approval of this QA program change is required for one licensee prior to being adopted by other licensees in accordance with YOCfR 50.54(a)(4).

Junction CC& Hwy Fulton MO 65251 AmerenMissouri corn 460 STARS Alliance

ULNRC-06254 October 7, 2015 Page 2 The following documents are enclosed pursuant to 10 CFR 50.54(a)(4)(ii):

1. Attachment 1, Description and Justification for Changes, explains the proposed changes to the OQAM and provides the reason for the changes, as well as the basis for concluding the OQAP (as revised) continues to meet the requirements of 10 CFR 50 Appendix B.

2. Attachment 2, OQAM Revision 31 Mark-Up for OQAMCN 15-002, identifies changes through the use of strikeovers and inserts.

In accordance with the provisions of 10 CFR 50.54(a)(4)(iv), NRC review and approval of the proposed change to the OQAP is requested by December 7, 2015.

This letter contains no new commitments. for questions concerning this letter, please contact Earl Mayhorn at 314-605-9701.

Sincerely, F. M. Diya Senior Vice President and Chief Nuclear Officer JPK Attachments 1) Description and Justification for Changes

2) OQAM Revision 31 Mark-Up for OQAMCN 15-002

ULNRC-06254 October 7, 2015 Page 3 cc: Mr. Marc L. Dapas Regional Administrator U. S. Nuclear Regulatory Commission Region IV 1600 East Lamar Boulevard Arlington, TX 76011-4511 Director Division of Spent fuel Management Office of Nuclear 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 Klos Project Manager, Callaway Plant Division of Operating Reactor Licensing Office of Nuclear Reactor Regulation U. S. Nuclear Regulatory Commission Mail Stop O8H4 Washington, DC 20555-0001 Mr. Y. Diaz-Castillo Reactor Operations Engineer Office of New Reactors U. S. Nuclear Regulatory Commission Mail Stop T-D24 Washington, DC 20555-0001

ULNRC-06254 October 7, 2015 Page 4 Index and send hardcopy to QA File A160.0761 Hardcopy:

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

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

F. M. Diya D. W. Neterer L. H. Graessle I. E. Herrmann B. L. Cox L. H. Kanuckel S. A. Maglio T. B. Elwood M.A. Hilistrom E. R. Mayhorn Corporate Communications NSRB Secretary STARS Regulatory Affairs Mr. John ONeill (Pillsbury Winthrop Shaw Pittman LLP)

Missouri Public Service Commission

Attachment 1 to ULNRC-06254 Operating Quality Assurance Manual (OQAM) Revision 31, Change Notice 15-002 Description and Justification for Changes 4 Pages

OPERATING QUALITY ASSURANCE MANUAL (OQAM) REVISION 31, CHANGE NOTICE 15-002 DESCRIPTION AND JUSTIFICATION FOR CHANGES Description of the Change:

OQAM CN 15-002 incorporates a QA program alternative that was approved by the NRC through the NRCs Final Safety Evaluation for Technical Report NET 14-05, Guidelines for the Use of Accreditation in Lieu of Commercial Grade Surveys for Procurement of Laboratory Calibration and Test Services, Revision 1. The Safety Evaluation Report (SER) was dated February 9, 2015. The alternative takes advantage of the internationally recognized standards and accreditation process when qualifying suppliers to perform calibration and test services for the nuclear industry. This would permit Ameren Missouri to procure commercial grade calibration or testing laboratory services and rely on the laboratory accreditation by Accreditation Bodies tABs) that are signatories to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA)

(referred to as the ILAC process) in lieu of commercial grade surveys to provide the necessary evidence of compliance to qualify calibration or test suppliers under the Commercial Grade Dedication process.

Reason for the Change:

The OQAM change provides resource utilization benefits to Ameren Missouri resulting from a reduction in the duplication of effort for qualifying the affected suppliers while ensuring that the requirements for commercial grade dedication continue to be met. This also results in the ability to reallocate resources to focus on suppliers requiring additional oversight.

Continued Compliance with 10 CFR 50 Appendix B:

The NRC SER for Technical Report NEI 14-05 expanded the NRCs acceptance of laboratory accreditations based on ANSI/ISO/IEC 17025:2005 by Accreditation Bodies (ABs) which are signatories to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Agreement (MRA). The NRCs acceptance of the ILAC accreditation process was previously limited to domestic calibration laboratories accredited to ISO/IEC 17025:2005 by domestic ABs which are signatories to the ILAC MRA as documented in the NRCs Arizona Public Service (APS) SER dated September 28, 2005 (ADAMS Accession No. ML052710224). Callaway Energy Center (CEC) previously incorporated the APS SER into the Operating Quality Assurance Manual (OQAM) via OQAM Change Notice 07-004.

An industry team led by the Nuclear Energy Institute (NET) developed NEI 14-05 which provides a methodology to utilize both calibration and testing service laboratories based on accreditation to ANSL/ISO/IEC 17025:2005 by domestic and international ABs which are signatories to the ILAC 1

MRA in lieu of performing a commercial grade survey. NEI 14-05, Revision 1 was submitted to the NRC for endorsement in August 2014. The NRCs endorsement of NEI 14-05, Rev. 1 was documented in the NRC SER dated february 9, 2015. The NRC did not take any exceptions to the methodology addressed in NEI 14-05, Rev. 1. In accordance with NRC guidance, NEI issued the approved document as NET 14-05A, Revision 0 (with the A suffix indicating NRCs acceptance).

The guidance outlined in NEI 14-05A applies directly to Callaway Energy Center as a methodology for approving laboratories of commercial calibration and testing services. The Operating Quality Assurance Manual (OQAM) changes addressed herein incorporate the guidance identified in NET 14-05A, Revision 0. OQAMCN 15-002 implements changes to the OQAM and commitments to Reg.

Guides 1.123 and 1.144 needed to permit the procurement of commercial grade calibration and testing services from laboratories accredited to ISO/IEC 170025:2005 based on the laboratory being accredited by an Accreditation Body (AB) which is a signatory to the ILAC MRA. These changes are based on the NRC endorsement of the ILAC accreditation process outlined in NET 14-05A. The NRCs endorsement was documented in a NRC SER dated february 9, 2015 which was addressed to NEI.

The implementation of the QA program controls identified in NET 14-05A, as reflected in the OQAM markup, provide assurance that signatories under the ILAC process will provide calibration and testing services with a confidence level equivalent to that obtained via the commercial grade survey, thus satisfying the requirements for commercial grade dedication of these services. The ILAC process is recognized as essentially equivalent to the NRC-accepted practices for commercial grade surveys that comply with the applicable requirements of 10 Cf R 50 Appendix B and 10 CFR Part 21.

Section by Section Description of the Change:

The OQAM CN 15-002 wording includes wording to address the needed changes in OQAM Sections 4, 7, 18 and the Appendix A Sections for Reg. Guides 1.123 and 1.144. Each subsection to be changed, as well as a description of the change itself and the justification for the change, is identified or provided on the following table (Table 1).

2

Table 1 OQAM CN 15-002 Section Change Description Justification Section 4.8.2 was revised and new section 4.9 was added to incorporate the guidance of NEI 14-05A, Revision 0 as it relates to use of the ILAC accreditation process and specifically to include the requirements that must be invoked in procurement The wording in Section 4.8.2 was replaced and new 4.8.2 and documents. The wording section 4.9 was added in order to incorporate the new 4.9 which was added in OQAM wording included in NEI 14-05A and the associated CN 07-004 to implement NRC SER.

the APS SER was removed, as applicable, since NEI 14-05A supersedes the APS SER. Changes to 4.10, 4.11, 4.12, 4.13, 4.14, and 4.15 are only the result of renumbering sections to incorporate changes to earlier sections.

Sections4.9,4.10,4.11, 49 410 4.12, 4.13, 4.14, and 4.15 There were no changes to the text within these sections.

4 were renumbered to The sections were renumbered due to addition of a new 413 414 accommodate a new section section 4.9.

and 4.15 Section 7.6 was revised to remove the reference to the NRC Licensee Contractor and Vendor Inspection The LCVIP reports are no longer in publication. The Program (LCVIP) Vendor . .

. wording in Section 7.16 now simply uses the term 7.6 Inspection reports. The ,,

. . . NRC Vendor Inspection Reports to refer to such wording in Section 7.16

. reports.

now simply uses the term NRC Vendor Inspection Reports to refer to such reports.

Section 7.15 was revised to 7.15 change the word on to the This change is editorial in nature.

phrase based on.

3

Table 1 Section Change Description Justification Section 7.16.1 was revised to incorporate the guidance of NET 14-05A, Revision 0 as it relates to use of the ILAC accreditation process The wording that was added in OQAM CN 07-004 to and specifically to include 7.16.1 implement the APS SER was removed, as applicable, the requirements for since NET 14-05A supersedes the APS SER.

evaluation of laboratories approved via the ILAC accreditation process and the associated receiving inspection requirements.

Section 18.10.1 was revised to incorporate the guidance of NEI 14-05A, Revision 0 as it relates to use of the The wording that was added in OQAM CN 07-004 to ILAC accreditation process 12.10.1 implement the APS SER was removed, as applicable, and specifically to include since NEI 14-05A supersedes the APS SER.

the requirements for evaluation of laboratories approved via the ILAC accreditation process.

Section 18.12 was revised to add testing services and to Section 18.12 was revised to add testing services and to clarify that the laboratorys clarify that the laboratorys accreditation must be 18.12 accreditation must be specific to the services supplied to Callaway Energy specific to the services Center.

supplied to Callaway Energy Center.

Appendix A for Reg. Guide 1.123 was revised to include the guidance of NEI 14-The wording that was added in OQAM CN 07-004 to Appendix 05A, Revision 0 including implement the APS SER was removed, as applicable, A requirements for evaluation since NEI 14-05A supersedes the APS SER.

of the laboratory, procurement documents, and receiving inspections.

Appendix A for Reg. Guide 1.144 was revised to include The wording that was added in OQAM CN 07-004 to Appendix the guidance of NEI implement the APS SER was removed, as applicable, A 14.05A, Revision 0, since NEI 14-05A supersedes the APS SER.

including requirements for evaluation of the laboratory.

4

Attachment 2 to ULNRC-06254 OQAM Revision 31 Mark-Up for OQAMCN 15-002 14 Pages

, SECTION NO. 4 WAmerdfi 031 MISSOURI CALLAWAY NUCLEAR PLANT OPERATING QUALITYASSURANCE MANUAL DATE: 2/15 4.5 Purchase requisitions must be employed to initiate the procurement of safety-related materials, parts, components, and services while ESAs must be used to contract for safety-related engineering, construction, or consultant services. Contracts, purchase orders generated from purchase requisitions, and ESAs must be employed to procure certain goods and services associated with the nuclear fuel cycle. Purchase requisitions for safety-related materials, parts, components, and services and ESAs for professional services may be initiated by personnel in the Nuclear Oversight Department; Nuclear Engineering; fuel Cycle Management Department; or the unit staff.

4.6 The procurement of spare or replacement parts for safety-related structures, systems, and components shall be subject to the QA Program controls in effect at the time the order is issued; and to codes, standards, and technical requirements which are equal to or better than the original requirements or as may be required to reduce the probability for repetition of defects. Procurement document control preparation measures shall further assure that safety-related components, piece parts, materials, and services are purchased to specifications and codes equivalent to those specified originally or those specified by a properly reviewed and approved revision; packaged and transported in a manner to assure the non-degradation of quality during transit; and properly documented to show compliance with applicable specifications, codes, and standards.

4.7 Each item or service to be procured is evaluated by the procurement document originator to determine whether it performs a safety-related function or involves activities which affect the function of safety-related materiats, parts, or components and to appraise the importance of this function to Plant or public safety. For those cases where it is unclear if an individual piece (part of a safety-related structure, system, component or service) is governed by the OQAP, an engineering evaluation shall be conducted. The evaluation shall be conducted by Nuclear Engineering and shall classify the safety relationship of the service or questionable component, parts or items of safety-related structures, systems, and components. Evaluations shall be documented for future reference.

4.8 Provisions for the following shall be included in procurement documents as applicable. These provisions may be addressed by invoking a suppliers approved quality program in the procurement document.

1) The scope of work and basic administrative and technical requirements including drawings, specifications, regulations, special instructions, and applicable codes and industrial standards and procedural requirements identified by titles and revision levels. Procurement documents shall also include special process instructions; identification of inspection, test and acceptance requirements; and any special requirements for activities such as designing, identifying, fabricating, cleaning, erecting, packaging, handling, shipping, and storing.

2) Requirement that the supplier have an acceptable Quality Assurance Program which implements the appropriate sections and elements of ANSI N45.2-1977 or the ASME code as applicable as established for the item or service to be supplied. This requirement is not applicable to commercial grade items which utilize a suppliers standard or proven design to meet published product descriptions. When pso+/-tring commercial grade calibration servieofrom-ealibration laboratoric accredited by a AMCN I 15001 nationally recognized accrediting body, such accreditation may he accepted in lieu of procuring such services from a supplier with a QA Program consistent with ANSI N 15.2 1077, provided all the following are met:

The accreditation is to ANSI!ISO/IEC 17025.

The acerediting body is either the National Voluntary Laboratory Accreditation Program (NVLAP) or the American Association for Laboratory Accreditation (A2LA), as recognized by NVLAP through the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Agreemcnt (MRA).

The published scope of accreditation for the calibration laboratory covers the needed measurement parameters, ranges and uncertainties.

Page 2 of4

, SECTION NO. 4 ViAmerdn REVISION: 031 MISSOURI CALLA WAY NUCLEAR PLANT OPERATING QUALITYASSURANCE MANUAL DATE: 2/15

The-ement docurncnts impose additional tDchnicul and admi necessary tn ;Mifv Amcrcn Missouri QA program and tcchnieal r c procurement doctimcnts . reporting as found and a; left used durin2 calibration.

3) Requirements for supplier surveillance, audit, and inspection including provisions for Ameren Missouri or agent access to facilities and records and for identification of witness and hold points.

4) Requirements for extending applicable requirements of Ameren Missouri procurement documents to lower-tier suppliers and subcontractors. These requirements shall include right-of-access to subsupplier facilities and records by Ameren Missouri.

5) Requirements for suppliers to obtain Ameren Missouri approval of nonconformances to procurement document requirements dispositioned use-as-is and repair and conditions of their disposition including identification of those subject to Ameren Missouri approval prior to further processing.

6) Applicability of 10 CER 21 reporting requirements.

7) Documentation requirements including records to be prepared, maintained, submitted for approval, or made available for review, such as, drawings, specifications, procedures, procurement documents, inspection and test records, personnel and procedural qualifications, chemical and physical test results, and instructions for the retention, transfer, and disposition of records.

8) Requirements that the supplier furnish documentation which identifies the purchased item and provides traceability to the procurement requirements met by the item and documentation identifying any procurement requirements which have not been met.

4.9 Commercial grade calibration and/or testing services may be procured fiom commercial laboratories based on the laboratorys accreditation to ISO/I EC-17025 by an Accreditation Body (AB) which is a signatory to OAMCN l5-00 the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA) provided all of the following are met:

1) A documented review of the suppliers accreditation is performed and includes a verification of the following:

a. The calibration or test laboratory holds accreditation by an accrediting body recognized by the ILAC MRA. The accreditation encompasses ISO/IEC-17025:2005, General Requirements for the Competence of Testing and Calibration Laboratories.

b. For procurement of calibration services, the published scope of accreditation for the calibration laboratory covers the needed measurement parameters, ranges, and uncertainties.

c. For procurement of testing services, the published scope of accreditation for the test laboratory covers the needed testing services including test methodology and tolerances/uncertainty.

2) The purchase documents require that:

a. The service must be provided in accordance with their accredited ISO/IEC-17025:2005 program and scope of accreditation.

b. As found calibration data must be reported in the certificate of calibration when calibrated items are found to be out-of-tolerance. (fbr calibration services only)

c. The equipment/standards used to perform the calibration must be identified in the certificate of calibration. (for calibration services only)

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., SECTION NO. 4 VIAmeren REVISION: 031 MISSOURi CALLAWAY NUCLEAR PLANT OPERATING QUALITYASSURANCE MANUAL DATE: 2/15 OQAMCN U. The customer must be notified of any condition that adversely impacts the laboratorys15-002 ability to maintain the scope of accreditation.

e. Additional technical and quality requirements, as necessary, based upon a review of the procured scope of services, which may include, but are not necessarily limited to, tolerances, accuracies, ranges, and industry standards.

3) It is validated, at receipt inspection, that the laboratorys documentation certifies that

a. The contracted calibration or test service has been performed in accordance with their lSO/IEC-17025:2005 program, and has been performed within their scope of accreditation, and

b. The purchase orders requirements are met.

494.l0 The originating organization shall perform a documented independent review of procurement documents to assure requirements are correctly stated, inspectable, and controllable and that there are adequate acceptance and rejection criteria. This review shall be performed by personnel who have access to pertinent information, and who have an adequate understanding of the requirements and intent of the procurement documents.

4404.11 Bids or proposals shall be evaluated by individuals or groups to evaluate the following subjects, as applicable to jhe type ofprocurement as described in 4.10.1, 4.10.2, 4.10.3, and 4.10.4:

1) Technical considerations

2) Quality Assurance requirements

3) Research and development effort

4) Suppliers personnel qualifications

5) Suppliers production capability

6) Suppliers past performance

7) Alternates

8) Exceptions

1. 10.1-4.11.1 Supply Chain Operations shall initiate and coordinate bid evaluation activities for those proposals received in response to requisitions. Supply Chain Operations shall review bids or proposals, except those associated with ESAs or nuclear fuel cycle related goods or services, for alternates or exceptions to procurement document requirements (areas 7 and 8 above) taken by the Supplier. These reviews shall be documented.

1.10.24.11.2_The originating organization shall review bids or proposals in all eight areas for ESAs; and for parts, equipment, or services that are not a direct replacement, or from the original approved supplier. They shall also review areas I through 3 above for replacement parts or equipment ordered from the original supplier as part of procurement document preparation.

1.1 t).3 1.11.3 The Nuclear Oversight Department and the originating organization review areas 4 through 6 above as part of maintaining a supplier on the Qualified Supplier List as described in the OQAM, Sections 7.0 and 18.0.

1.10.44.11.4_The Fuel Cycle Management Department shall evaluate bids or proposals for fuel cycle goods or services in the above areas.

44-1-4.12 Bids or proposals with alternates or exceptions identified in Section 4.10 by Supply Chain Operations shall also be evaluated by the originating organization to provide additional assurance that no unacceptable conditions result from such changes. Unacceptable conditions identified in bid or proposal evaluations shall be resolved prior to purchase award.

Page 4 of 4

, SECTION NO. 4 WAmerefi REVISION: 031 MISSOURI CALLAWAY NUCLEAR PLANT OPERATING QUALITYASSURANCE MANUAL DATE: 2/15 4-444.13 Letters of intent may be utilized with suppliers of materials, parts, components, and services for the purpose of reserving schedule space prior to the resolution of the commercial requirements to be included in a purchase order, contract, or ISA. If employed, letters of intent must normally specify that no safety-related activities may begin until an approved purchase order, contract, or ESA is executed. Letters of intent shall be prepared, approved and issued by Supply Chain Operations for those suppliers to be covered by purchase order, by the originating organization for ESAs, or by the Fuel Cycle Management Department for contracts for nuclear fuel cycle-related goods andlor services. However in the event a letter of intent is issued for the purpose of securing an agreement and thereby allotv safety-related work to begin prior to the issuance of such documents, it shall include the applicable quality and technical requirements, as specified by the originating organization.

4-l-34.14 Supply Chain Operations is responsible for reviewing purchase orders to verify that the technical and quality requirements have been accurately transferred from the requisition to the purchase order. Approval of the purchase requisition, letter of intent, ESA, or contract shall be by an individual who has approval authority and signifies that the technical and quality review of the document has been completed. Contracts initiated for nuclear fuel cycle-related goods and/or services shall be the responsibility of the Senior Vice President and Chief Nuclear Officer with preparation and negotiation by the Fuel Cycle Management Department.

Nuclear fuel cycle-related contracts and ESAs for professional services shall be executed by the Senior Vice President and Chief Nuclear Officer or another company officer in accordance with Nuclear Generation and corporate procedures related to agreements or contracts for services.

4-444.15 Additions, modifications, exceptions, and other changes to procurement document quality and technical requirements shall require a review equivalent to that of the original document and approval by the originator or the originating department approval authority. Commercial consideration changes shall not require review and concurrence by the originator. Conditions specified on the Qualified Suppliers List (QSL) that apply to a vendor may be revised without concurrence from the originating organization since they are imposed withocit the knowledge of the originator.

Page 5 of 4

, SECTION NO. 7 71Ameret REVISION: 031 MISSOURI CALLAWAY NUCLEAR PLANT OPERATING QUALITYASSURANCE MANUAL DATE: 2/15 7.5 Procurement source evaluation and selection involves the Nuclear Oversight Department and the originating organization. The evaluation and selection process shatl be specified in department procedures and may vary depending on the complexity and relative importance to safety of the item or service. Nuclear Engineering, fuel Cycle Management, the unit staff or other organizations may be requested to provide input to the qualification evaluations of suppliers.

7.6 Procurement source selection and evaluations shall consider one or more of the following:

f OQAMCN 15-002

1) Experience of users of identical or similar products of the prospective supplier. NRC Licensee Contractor and Vendor lnpection Prooram (LCVIP) Vendor Inspection reports, ASME Certificates of Authorization (C of A), audit reports, Ameren Missouri records accumulated in previous procurement actions, and Ameren Missouri product-operating experience may be used in this evaluation. Supplier history shall reflect recent capability. Previous favorable quality experience with suppliers may be an adequate basis for judgments attesting to their capability. When an NRC Vendor Inspection report n LCYIP report, an audit report, or an ASME C of A is used to establish a suppliers acceptability as a procurement source, the document shall be identified.

2) An evaluation of the suppliers current quality records supported by documented qualitative and quantitative information which can be objectively evaluated. This may include review and evaluation of the suppliers QA Program, Manual, and Procedures, as appropriate; and responses to questionnaires.

3) A source evaluation of the suppliers technical and quality capability as determined by a direct evaluation (audit or surveillance) of facilities, personnel and Quality Assurance Program implementation.

4) For commercial grade items, the procurement source selection should consider one or more of the following:

a) Survey of documented supplier controls over critical characteristics and that supplier activities adequately control the items supplied, and verify the implementation of manufacturers measures for control of design, process, and material changes.

b) Acceptable supplier/item performance record utilizing monitored performance of the item, industry product tests, national codes, and standards (not specific to the nuclear industry), or other industry databases (UL, TNPO NPRDS, EPRI EQDB, ANSI, NEMA, MIL-STDS, NRC Bulletins/Notices, and Licensee Event Reports, etc.) that is directly related to the items critical characteristics and intended application.

7.7 Procurement source evaluations involve a review of technical and quality assurance considerations.

Technical considerations include the design or manufacturing capability and technical ability of suppliers to produce or provide the design, service, item, or component. Quality assurance considerations include one of the previously defined methods of supplier evaluation and a consideration of changes in a suppliers Quality Assurance Program or capabilities. The measures employed to evaluate a suppliers continued acceptability as a procurement source (after the initial source evalciation) are described in Section 18.

7.8 Organizations participating in the procurement process shalt prepare procedures to monitor and evaluate suppliers performance to procurement document requirements. These procedures shall include provisions for: 1) controlling documents generated or processed during activities fulfilling procurement requirements;

2) identifying and processing change information; 3) establishing a method of control and documentation of information exchange with the supplier; and 4) audit or surveillance of supplier activities.

Page 2 of 5

, SECTION NO. 7 Amerefl MISSOURI REVISION: 031 CALLAWAY NUCLEAR PLANT DATE: 2/15 OPERATING QUALITYASSURANCE MANUAL 3.15 Commercial grade items shall rely on proven design and utilize verification methods by the purchaser, to the OQAMCN extent appropriate to item application. Procedures provide for the acceptance of commercial grade items15-002 based on one or more of the following:

1) Special Tests and Inspections

2) Survey of Supplier (Commercial Grade)

3) Source Verification

4) Acceptable Supplier/Item Performance Record Method 4 should not be used alone unless:

a. The established historical record is based on industry wide performance data that is directly applicable to the items critical characteristics and the intended safety-related application; and

b. The manufacturers measures for the control of design, process, and material changes have been adequately implemented as verified by audit (multi-licensee team audits are acceptable).

7.16 Where required by Code, regulation or contract requirement, documentary evidence that items conform to procurement documents shall be available during receiving inspection or prior to use of such items. Where not precluded by other requirements, documentary evidence may take the form of written certificates of conformance. When certificates of conformance are employed as a means of item acceptance, verification of the validity of supplier certificates and the effectiveness of the certification systems shall be conducted at intervals commensurate with the suppliers past quality performance. Certificates of conformance and compliance shall be required to be signed or accompanied by a signed letter of transmittal. Where acceptance is based upon source verification, documented evidence of these surveillances shall be furnished to the Plant Quality Control organization by the responsible Ameten Missouri organization or their designated agent prior to acceptance.

7.16.1 When purchasing commercial grade calibration or testing services from a laboratory holding accreditation by rOA\fCN an accrediting body recognized by the International Laboratory Accreditation Cooperation (ILAC) Mutual l5Oo Recognition Arrangement (MRA), commercial urade surveys need not be performed provided all of the following conditions are met:

1) A documented review of the suppliers accreditation is performed and incltides a verification of the following:

a. The calibration or test laboratory holds accreditation by an accrediting body recognized by the ILAC MRA. The accreditation encompasses ISO/IEC-17025:2005, General Requirements for the Comnetence of Testing and Calibration Laboratories.

b. for procurement of calibration services, the published scope of accreditation for the calibration laboratory covers the needed measurement parameters, ranges. and uncertainties.

c. For procurement of testing services, the published scope of accreditation for the test laboratory covers the needed testing services including test methodology and tolerances/uncertainty.

2) It is validated, at receipt inspection, that the laboratorys documentation certifies that:

a. The contracted calibration or test service has been performed in accordance with their ISO/IEC-17025:2005 program, and has been performed within their scope of accreditation, and

b. The purchase orders requirements are met.

7.16.1 suppliers commercial grade calibration ervice accreditation nationally recognizcd aecrediting body, a documented review of the suppliers accreditation by the purchaser may bc used in lieu of inspections or tcsts following delivery or in proccss survcillanccs during performance of thc scrvice. This review shaH include, at a minimum, aH the foHowin:

Page 4 of 5

, SECTION NO. 7 Ameren MISSOURI REVISION: 031 CALLAWAY NUCLEAR PLANT OPERATING QUALITY ASSURANCE MANUAL DATE: 2/15 rThe OQAMCN 15002 i ih_ accrcditmg uuuy i LWIC[ we National Voluntary Laboratory ccreditation lrogram xrs ,riw,,

--- a n\

or thc American Association for Laboratory Accreditation (A2LA), n recognized by NVLAP tlough thc International Laboratory Accreditation Cooperation (I LAC) Mutual Recognition Agreement (M RA).

F-rn[42t tflflC 7.17 Acceptance by receiving inspection shall be utilized as a prime method of verification and may be utilized as the sole means of item acceptance when items are relatively simple and standard in design and manufacture, such as certain spare parts; when items are adaptable to standard or automated inspections; and when inspections do not require operations which could adversely affect the integrity, ftinction, or cleanliness of the item. When other methods are utilized, receiving inspection shall be employed to verify that items have not sustained damage.

7.18 Receiving inspection shall be performed by personnel certified to ANSI N45.2.6 1978, (as clarified in OQAM Appendix A Regulatory Guide 1.58) under the direction of the Quality Control organization. Other unit staff personnel qualified to ANS 3.1 1978 may be utilized to perform receipt inspections requiring specialized skills, such as receipt inspection of radioactive material, bulk chemicals and diesel fuel. During outages, extensive modifications, or other special circumstances, receiving inspection may be assigned to an outside organization(s).

7.19 Final acceptance of items shall be by Quality Control personnel or designated inspection personnel. The final acceptance of services shall be the responsibility of the originating organization. Acceptance shall be documented.

7.20 Receiving inspection activities shall include:

1) Verifying that materials, parts, and components, have been identified by tagging or other means; or that they are segregated and controlled in areas separate from the storage facilities for accepted items.

2) Verifying that items for acceptance have been examined for physical damage, correctness of identification and quality documentation, and completeness of specified quality documentation.

3) Verifying that received items conform to procurement documents by inspecting or, where appropriate, testing using approved procedures and calibrated tools, gages and measuring equipment to verify the acceptability of items, including those from commercial grade suppliers.

4) Providing final acceptance after determining that required verifications are complete and acceptable.

Items determined to be acceptable for use shall be tagged with an accept tag or other means of identification or segregation, and released for storage or use. Conditional acceptance of items by receiving inspection shall be procedurally controlled.

5) Verifying that received items which do not conform to procurement documents are segregated (if practicable) and processed in accordance with Section 15.

7.21 Acceptance by post-installation test may be utilized following one of the preceding acceptance methods.

Post-installation testing shall be used as the prime means of acceptance verification when it is difficult to verify item quality characteristics; the item requires an integrated system checkout or test; or the item cannot demonstrate its ability to perform when not in use. Post-installation test requirements and acceptance documentation shall be established by Ameren Missouri.

PageS of5

, SECTION NO. 1$

Ameren MISSOURI REVISION: 031 CALLAWAY NUCLEAR PLANT OPERATING QUALITYASSURANCE MANUAL DATE: 2/15 18.8.1 In addition to audits conducted under the cognizance of the NSRB, the following areas shall be reviewed or audited per the frequency specified in applicable regulations:

Radiological Protection program Security program Access Authorization Fitness-For-Duty program Radiological Emergency Response Plan 18.8.2 In addition to the audits conducted under 1$.$.a)j) and 18.8.1, a triennial Fire Protection Program audit shall be conducted with an audit scope that includes the following:

a) FP Program as defined in FSAR SP, Section 9.5.1; b) Fire Protection Quality Assurance Program (FSAR-SP, Section 9.5.1.6.2);

c) NFPA 805 Fire Protection Monitoring Program (FSAR-SP, Section 9.5.1.4.2);

d) This triennial audit utilizes a qualified outside independent Fire Protection Consultant (non Ameren).

18.9 During Plant modifications or other major unique activities, audits shall be scheduled as required to assure that Quality Assurance Program requirements are properly implemented.

18.10 External audits shall be conducted by or for the NOS Department as a method for the evaluation of procurement sources and as a post-award source verification of conformance to procurement documents. Audits conducted by other organizations (with similar orders with the same supplier), including other utilities or AEs, may be employed as a means of post-award source verification in lieu of Ameren Missouri performed audits and may not necessarily audit specific items furnished to Ameren Missouri. These audits and surveillances shall utilize personnel qualified in accordance with this OQAM and shall be conducted in accordance with this OQAM and NOS Department procedures. Commercial grade items do not require pre-or post-award audits. Similarly, items which are relatively simple and standard in design and manufacture may not require supplier qualification or post-award audits to assure their quality.

18.10.1 When purchasing commercial grade calibration or testing services from a laboratory holding accreditation by OQAMCN an accrediting body recognized by the International Laboratory Accreditation Cooperation (ILAC) Mutual 15-002 Recognition Arrangement (MRA), commercial grade surveys need not be performed provided all of the following conditions are met:

1. A documented review of the suppliers accreditation is performed and includes a verification of the foltowin:

a. The calibration or test laboratory holds accreditation by an accrediting body recognized by the ILAC MRA. The accreditation encompasses ISO/IEC-17025:2005, General Requirements for the Competence of Testing and Calibration Laboratories.

b. For procurement of calibration services, the published scope of accreditation for the calibration laboratory covers the needed measurement parameters, ranges, and uncertainties.

c. For procurement of testing services, the published scope of accreditation for the test laboratory covers the needed testing services including test methodology and tolerances/uncertainty.

2. It is validated, at receipt inspection, that the laboratorys documentation certifies that:

a. The contracted calibration or test service has been performed in accordance with their ISO/IEC-l7025:2005 program, and has been performed within their scope of accreditation, and

b. The nurchase orders reouirements are met.

Page 3 of4

., SECTION NO. 18 Ameren MISSOURI REVISION: 031 CALLAWAY NUCLEAR PLANT OPERATING QUALITYASS URANCE MANUAL DATE: 2/15 OQAMCN nationally rccogmzcd accrcditing in lieu 15-002 or perfoning a commrrcinl .. supplier ntvv a be pcrformcd by or ror tne u uepartmem. i tiis rev the follov,inz:

ml.. ,. *-. ATC1/TC{TT( 1 71II The accrediting body is either the National Voluntary Laboratory Accreditation Program (NVLAP),

or the American Association for Laboratory Accreditation (A2LA), as recognized by NVLAP through the International Laboratory Accreditation Cooperation (I LAC) M utual Rccoition Agreement (MRA).

The published scope of accreditation for the calibration laboratory covers the needed measurement 18.11 Applicable elements of suppliers quality assurance programs shall be audited (post-award) on a triennial basis. Audits generally should be initiated when sufficient work is in progress to determine whether the organization is complying with the established quality assurance provisions. Subsequent contracts or contract modifications which significantly enlarge the scope of activities by the same supplier shall be considered in establishing audit requirements. In addition, the need for a triennial audit may be precluded upon evaluation and documentation by the NOS Department that the results of mini-audits performed during source verification and source surveillance activities confirm the adequacy and implementation of the suppliers QA Program.

18.12 Supplementary to audits, annual evaluations of suppliers shall be performed which take into account, as applicable: 1) the review of supplier furnished documents such as certificates of conformance, nonconformance notices, and corrective actions; 2) results of previous source verifications, audits, and receiving inspections; 3) operating experience of identical or similar products furnished by the same supplier; 4) results of audits from other sources, and 5) for providers of commercial-grade calibration and testing services, continued maintenance of laboratory accreditation for the specific services supolied to Callaway Energy Center.

18.13 Audits shall also be conducted when: 1) significant changes are made in functional areas of the Quality Assurance Program such as significant reorganization or procedure revisions; or 2) when it is suspected that the quality of the item is in jeopardy due to deficiencies in the Quality Assurance Program; or 3) when a systematic, independent assessment of Program effectiveness is considered necessary; or 4) when it is necessary to verify impleinentation of required corrective action.

18.14 Audits shall be conducted using written plans in accordance with NOS Department procedures. The procedures require evaluation of work areas, activities, processes, goods, services, and the review of documents and records for quality-related practices, procedures, and instructions to determine the effectiveness of the itnplementation of the OQAP and compliance with 10 CFR 50, Appendix B. The audit plan shall identify the audit scope, the requirements, the activities to be audited, organizations to be notified, the applicable documents, the schedule, and the written procedures or checklists as appropriate. The audit plan and any necessary reference documents shall be available to the audit team members.

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yj APPENDIX A r

r mereii MISSOURI REVISION: 031 CALLAWAY NUCLEAR PLANT DATE: 2/15 OPERATING QUALITY ASSURANCE MANUAL In regard to Section 2.5.2 of ANSI N45.2.5-1974 titled Calibration and Control: The last sentence is clarified as follows:

Ameren Missouris inspection or test results conducted with M&TE found to be discrepant are to be evaluated as described in the OQAM, Section 12.8.

With regard to Section 5.4 of AN SI N45.2.5-1974 titled High Strength Bolting: In lieu of the first two sentences in the first paragraph, Ameren Missouri will comply with the foltowing:

Bolts for friction type connections may be tightened using direct tension indicators in accordance with the AISC Specification for Structural Joints Using ASTM A325 or A490 Bolts, approved May 8, 1974.

In lieu of(1) in the second paragraph, Ameren Missouri will comply with the following:

The requirement for the acceptance of tightened bolt assemblies is, the length of the bolts shall be such that the point of the bolt shall be flush with or outside of the face of the nut when completely installed.

REGULATORY GUIDE 1.116 REVISION O-R DATED 5/77 Quality Assurance Requirements for Installation, Inspection, and Testing of Mechanical Equipment and Systems (Endorses ANSI N45.2.8-1975)

DISCUSSION:

Ameren Missouri complies with the recommendations of this Regulatory Guide with the following clarifications:

For maintenance and modification activities Ameren Missouri shall comply with the Regulatory Position established in this Regulatory Guide in that QA programmatic/administrative requirements included therein shall apply to these maintenance and modification activities even though such requirements may not have been in effect originally. Technical requirements associated with maintenance and modifications shall be equal to or better than the original requirements (e.g., code requirements, material properties, design margins, manufacturing processes, and inspection requirements), or as required to preclude repetition of defects.

With regard to Section 2.7 of ANSI N45.2.8 1975 titled Personnel qualifications: Personnel performing inspection and testing activities, shall be qualified consistent with the qualification requirements of OQAM Section 10 and, as endorsed in this Appendix, Regulatory Guide 1.58 [ANSI N45.2.6-1978] and Regulatory Guide 1.8 [ANSI/ANS 3.1-1978].

REGULATORY GUIDE 1.123 REVISION 1 DATED 7/77 Quality Assurance Requirements for Control of Procurement of Items and Services for Nuclear Power Plants (Endorses ANSI N45.2.13-1976)

DISCUSSION:

Ameren Missouri complies with the recommendations of this Regulatory Guide with the following clarifications:

With regard to Section 1.3 of ANSI N45.2.13 1976 titled Definitions: With two exceptions (Procurement Document and Quality Assurance Program Requirements) definitions in this Standard which are not included in Regulatory Guide 1.74 (ANSI N45.2.10) shall be used; definitions which are included in ANSI N45.2.10 shall be used as clarified in Ameren Page 20 of 29

p APPENDIX A mereii MISSOURI REVISION: 031 CALLA WAY NUCLEAR PLANT DATE: 2/15 OPERA TING QUALITYASSURANCE MANUAL Missouris commitment to Regulatory Guide 1.74. The two exceptions are defined in this Appendix under Regulatory Guide 1.74.

With regard to Section 1.2.2 of ANSI N45.2.13 1976 titled Purchasers Responsibilities: Item C is one of the options which may be used by Ameren Missouri to assure quality; however, any of the options given in 10 CFR 50, Appendix B, Criterion VII as implemented by OQAM Sections 4 and 7 may also be used.

With regard to Section 3.1 of ANSI N45.2.13 1976 titled Procurement Document Preparation, Review and Change Control: The phrase the same degree of control is stipulated to mean equivalent level of review and approval. The changed document may not always be re-reviewed by the originator; however, at least an equivalent level of supervision shall review and approve any changes.

With regard to Section 3.2.3 of ANSI N45.2.13 1976 titled Quality Assurance Program Requirements, the requirements of the Section are accepted with the following exceptions:

As defined in 10CFR21.3, basic components include: safety related structures, systems, components or parts thereof; and also include safety-related design, analysis, inspection, testing, fabrication, replacement of parts, or consulting services that are associated with the component hardware whether these services are performed by the component supplier or others.

Procurement documents for basic components are not required to impose a quality assurance program consistent with ANSI N45.2, provided that all the following are met:

1. The basic components meet the definition of commercial grade item in 10CFR21.3.

2. The basic components are dedicated by the Purchaser in accordance with the Purchasers 10CFR5O Appendix B quality assurance program as described in 10CFR21.3 and 10CFR21.2I(c).

3. The Purchaser adopts appropriate procedures for notifications to satisfr 10CFR2Y.21.

OQAMCN When purchasing commercial crade calibration or testing services from a laboratory holding accreditation by an accrediting 15-002 body recognized by the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRM. commerciat grade surveys need not be performed provided each of the following conditions are met:

1) A documented review of the suppliers accreditation is performed and includes a verification of the following:

a) The calibration or test laboratory holds accreditation by an accrediting body recognized by the ILAC MRA. The accreditation encompasses ISO/IEC-17025:2005, General Requirements for the Competence of Testing and Calibration Laboratories.

b) For procurement of calibration services, the published scope of accreditation for the calibration laboratory covers the needed measurement parameters, ranges, and uncertainties.

c) for procurement of testing services, the published scope of accreditation for the test laboratory covers the needed testing services including test methodology and tolerances/uncertainty.

2) The purchase documents require that:

a) The service must be provided in accordance with their accredited ISO/IEC-17025:2005 program and scope of accreditation.

Page 21 of29

APPENDIX A 2

mere MISSOURI REVISION: 031 CALLAWAY NUCLEAR PLANT DATE: 2/15 OPERA TING QUALITY ASSURANCE MANUAL b) As found calibration data must be reported in the certificate of calibration when calibrated items are found to be out of tolerance. (for calibration services only) c) The epuinment/standards used to perform the calibration must be identified in the certificate of calibration.

(for calibration services only) d) The customer must be notified of any condition that adversely impacts the laboratorys ability to maintain the scope of accreditation.

e) Additional technical and quality requirements, as necessary, based upon a review of the procured scope of services, which may include, but are not necessarily limited to, tolerances, accuracies, ranges, and industry standards.

3) It is validated, at receipt inspection, that the laboratorys documentation certifies that:

a) The contracted calibration or test service has been performed in accordance with their ISO/IEC 17025:2005 program, and has been performed within their scope of accreditation, and b) The purchase orders requirements are met.

OQAMCN When purchasing commercial grade calibration services from calibration laboratories accredited by a nationally recognized 15-002 ]accrediting body, the procurement documents are not required to impose a quality assurance program consistent with ANSI N45.2. Nationally recognized accrediting bodies include the National Voluntary Laboratory Accreditation Program (NVLAP) administered by the National Institute of Standards and Tcchiiology (NIST) and the American Association for Laboratory Accreditation (A2LA), as rccogzcd by NVLAP though the Inteational Laboratory accreditation Cooperation (ILAC) Mutual Rccotion Agreement (MRA). In such cases, accreditation may be accepted in lieu of the Purchaser imposing a QA Program consistent with ANSI N5.2, provided all the following arc met:

i. me accreuimiion is to t at,iauinu I

2. The accrcditing body is either NYLAP or A2LA, as recognized by NVLAP though the ILAC MRA.

3. The published scope of accreditaon for the calibration laboratory covers the needed measurement parameters, ranges and uncertainties.

4. T -- documents impose additional technical and administrative requirements, as necessary Amercn Missouri OA nrnm ..... nical rronirements.

i purchase documents require rvporting as IUU,kd uttu us tti calibration data, and identification of the stanaarns usea nttnn caHaranon.

With regard to Section 3.4 of ANSI N45.2.13 1976 titled Procurement Document Control: Ameren Missouri shall meet the requirements of OQAM Sections 4 and 7 in lieu of the requirements specified in this Section. In every case either identical or equivalent controls are provided in the sections of the referenced documents.

With regard to Section 5.3 of ANSI N45.2.l3 - 1976 titled Preaward Evaluation: Ameren Missouri shall comply with an alternate paragraph which reads:

Except in unusual circumstances (e.g. replacement parts are needed to preclude the development of some unsafe or undesirable condition at Callaway), an evaluation of the suppliers acceptability as a procurement source shall be performed as required by the Operating QA Manual.

Page 22 of29

APPENDIX A ffl1Cft REVISION: 031 MISSOURI CALLAWAY NUCLEAR PLANT DATE: 2/15 OPERA TING QUALITY ASSURANCE MANUAL While it is not the intent to make unusual circumstances determinations without Engineering or NOS involvement, Callaway Operations Support is ultimately responsible for the decision. NOS audit and surveillance activities assure against abuse.

With regard to Section 6.4 of ANSI N45.2.13 1976 titled Control of Changes in Items of Services: The phrase the Operating QA Program is inserted in lieu ofANSI N45.2, Section 7.

With regard to Section 7.3.1 of ANSI N45.2.13-1976 titled Source Verification Activities and Section 12 of ANSI N45.2.13 1976 titled Audit of Procurement Program: The Ameren Missouri audit program shall be implemented in accordance with and to meet the requirements of Regulatory Guide 1.144 (ANSI N45.2.12) as endorsed in this Appendix, and OQAM Sections 16 and 18.

With regard to Section 7.5 of ANSI N45.2.13 1976 titled Personnel Oualifications: The phrase: Personnel responsible for performing verification activities shall be qualified in accordance with ANSI N45.2.6 as applicable, is subject to the following clarification: Qualification of personnel performing verification activities for the Callaway Plant shall be in accordance with Ameren Missouris position on Regulatory Guide 1.58.

With regard to Section 8.2 of ANSI N45.2.13 - 1976 titled Disposition: The third sentence of item b is revised to read:

Nonconformances to the contractual procurement requirements or Purchaser approved documents and which consist of one or more of the following shall be submitted to the Purchaser for approval of the recommended disposition prior to shipment when the nonconformance could adversely affect the end use of a module or shippable component relative to safety, interchangeability, operability, reliability, integrity, or maintainability:

1) Technical or material requirement is violated;

2) Requirement in Supplier documents, which have been approved by the Purchaser, is violated;

3) Nonconformance cannot be corrected by continuation of the original manufacturing process or by rework; and/or

4) The item does not conform to the original requirement even though the item can be restored to a condition such that the capability of the item to function is unimpaired.

REGULATORY GUIDE 1.144 REVISION 1 DATED 9/80 Auditing of Quality Assurance Programs for Nuclear Power Plants (Endorses ANSI N45.2.12-1977)

DISCUSSION:

Ameren Missouri complies with the recommendations of this Regulatory Guide with the following clarifications:

A module is an assembled device, instrument, or piece of equipment identified by serial number or other identification code, having been evaluated by inspection and/or test for conformance to procurement requirements regarding end use. A shippable component is a part of sub-assembly of a device, instrument, or piece of equipment which is shipped as an individual item and which has been evaluated by inspection and/or test for conformance to procurement requirements regarding end use.

Page 23 of 29

APPENDIX A WAmerefi REVISION: 031 MISSOURI CALLAWAY NUCLEAR PLANT DATE: 2/15 OPERA TING QUALITY ASSURANCE MANUAL With regard to Section C3.b(2) of Regutatoty Guide 1.144, the requirements of the section are accepted with the following interpretation:

OQAMCN When procuring commercial grade calibration or testing services from a laboratory holding accreditation by an 15-002 accrediting body recognized by the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA). the accreditation process and accrediting body may be credited with carrying out a portion of the Purchasers duties of verifying acceptability and effective implementation of the calibration or testing service laboratorys quality assurance program.

In lieu of performing commercial grade survey ot accepting a commercial grade survey performed by another licensee, a documented review of the laboratorys accreditation is performed which includes a verification of the following:

1. The calibration or test laboratory holds accreditation by an accrediting body recognized by the ILAC MRA. The accreditation encompasses ISO/IEC-17025:2005. General Requirements for the Competence of Testing and Calibration Laboratories.

2. For procurement of calibration services, the published scope of accreditation for the calibration laboratory covers the needed measurement parameters, ranges, and uncertainties.

3. For procurement of testing services, the published scope of accreditation for the test laboratory covers the needed testing services including test methodology and tolerances/uncertainty.

OQAMCN

- prnciiustng commercial grauc calibration services irom calibration iaooratones accrcaneu ny a nationally 15-002 rprl7d npcrifing hnd th accreditation process and aecrediting body may be credited with carrying put UOH UI tUC Purchasers duties of verifying acceptability and effective implementation of the calibration service Nationally recognizcd accrediting bodies include the National Volunta Laboratory Accreditation Program (NVLAP) administered by the National Institute of Standards and Tccolo JIST) and the American Association for Laboratory Accreditation (A2LA), as recognized by NVLAP through thc International Laboratory Accreditation Cooperation (ILAC)

Mutual Recognition Agreement (MRA).

T__ l:_...

,IT mi,:

.__c,_,!_ _rfll L_ f_li

2. The accrediting body is either NVLAP or A2LA, as recognized by NVLAP through the ILAC MRA.

3. The published scope of accreditation for the calibration laboratory covers the needed measurement nnrnmrtr rc rinrc nnul nnrertninhec Also, annual evaluations of commercial-grade calibration service suppliers shall verify continued maintenance of laboratory accreditation.

With regard to Section 1.4 of ANSI N45.2.12 1977 titled Definitions: With one exception (Program Deficiencies) the definitions in this Standard which are not included in Regulatory Guide 1.74 (ANSt N45.2.1O) shall be used; definitions which are included in ANSI N45.2.10 shall be used as clarified in Ameren Missouris commitment to Regulatory Guide Page 24 of 29