ML22166A343

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Framatome Lnc., Submittal of Quality Assurance Program, FS1-0011462, Revision 8.0, 10 CFR 71, Subpart H Quality Assurance Program Description for Packaging and Transportation of Radioactive Materials for Us Fuel
ML22166A343
Person / Time
Site: 07100003, Framatome ANP Richland
Issue date: 06/10/2022
From: Peters G
Framatome
To:
Document Control Desk, Office of Nuclear Material Safety and Safeguards
References
NRC:22:009
Download: ML22166A343 (15)
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Text

,I framatome June 10, 2022 NRC:22:009 U.S. Nuclear Regulatory Commission Document Control Desk Division of Fuel Management Office of Nuclear Material Safety & Safeguards 11555 Rockville Pike Rockville, MD 20852 Submittal of Framatome lnc.'s Quality Assurance Program, FS1-0011462, Revision 8.0, "10 CFR 71, Subpart H Quality Assurance Program Description for Packaging and Transportation of Radioactive Materials for US Fuel" Ref. 1: Letter, Gary Peters (Framatome Inc.) to Document Control Desk (NRC), "Submittal of Framatome lnc.'s Quality Assurance Program, FS1-0011462, Revision 7.0, '10 CFR 71, Subpart H Quality Assurance Program Description for Packaging and Transportation of Radioactive Materials for US Fuel'," March 17, 2020, NRC:21:012.

Ref. 2: Letter, Gary Peters (Framatome Inc.) to Document Control Desk (NRC), "Minor Error in Framatome lnc.'s Quality Assurance Program, FS1-0011462, Revision 7.0, '10 CFR 71, Subpart H Quality Assurance Program Description for Packaging and Transportation of Radioactive Materials for US Fuel'," July 30, 2021, NRC:21 :027.

Framatome Inc. (Framatome) submitted Quality Assurance Program (QAP), FS1-0011464, Revision 7, "10 CFR 71, Subpart H Quality Assurance Program Description for Packaging and Transportation of Radioactive Materials for US Fuel," in Reference 1.

In the table of Revisions for FS1-0011464, Revision 7, the date of the revision was noted in error as "2020" instead of "2021." This error was identified in the workflow step prior to its placement in Framatome's repository. Additionally, a letter was provided to the NRC in Reference 2 to describe the error. Because this error was minor in nature (typo) and the error had no impact on the contents of the QAP, the error was documented for correction on the next revision in accordance with our processes. This issue did not reduce the effectiveness of the information contained in FS1-0011464, Revision 7.

In subsequent conversations with NRC staff, a request was made for Framatome to submit a revised copy of the QAP correcting the error. Enclosed is a revised QAP. Please finalize the review of the QAP with reference to the enclosure to this letter.

Framatome Inc.

3315 Old Forest Road Lynchburg, VA 24501 Tel: (434) 832-3000 www.framatome.com

Document Control Desk NRC:22:009 June 10, 2022 Page 2 If you have any questions related to this information please contact Ms. Gayle F. Elliott, Deputy Director, Licensing & Regulatory Affairs, by telephone at (434) 832-3347, or by e-mail at Gayle.Elliott@framatome.com.

cc: N. Otto

0. Siurano-Perez License SNM-1227 Docket 70-1257

Enclosure:

1) FS1-0011462, Revision 8.0, "10 CFR 71, Subpart H Quality Assurance Program Description for Packaging and Transportation of Radioactive Materials for U.S. Fuel"

IDENTIFICATION REVISION FS1-0011462 8.0 Framatome I 11 I Fuel framatome TOTAL NUMBER OF PAGES: 13 10 CFR 71, Subpart H Quality Assurance Program Description for Packaging and Transportation of Radioactive Materials for US Fuel ADDITIONAL INFORMATION:

QAPD, 10CFR71 Subpart H PROJECT <Enter with F11 > DISTRIBUTION TO PURPOSE OF DISTRIBUTION HANDLING None CATEGORY QAP - Quality Plan STATUS <Enter with F11 >

This document is electronically approved. Records regarding the signatures are stored in the fsanpexp I EDRMS object Id.: 09012167812d52b7 Documentum docbase. Any attempt to modify this file may subject employees to civil and criminal penalties. Released date (Western EU time): 2022/01/26 00:05:24 Role Name Date (YYYY/MM/DD) Organization Writer GARCIA Paul 2022/01/25 01:26:05 Framatome Inc.

Reviewer MCQUADE Patrick 2022/01/25 01:50:49 Framatome Inc.

Reviewer ELLIOTT Gayle 2022/01/25 23:43:03 Framatome Inc.

Approver STEPHENS Lance 2022/01/26 00:05:24 Framatome Inc.

Classification ExQort AL: 0E001 ECCN: 0E001 RELEASE DATA: Les marchandises portant la d8signation "AL inegal N" sent soumises a la r8glementation europeenne ou allemande en matiere de contrOle des exportations au sein ou hors de l'UE. Les marchandises portant la designation "ECCN in8gal N" sont soumises a la r8glementation am8ricaine. Les marchandises portant les dt'lsignations "AL:N" ou "ECCN:W peuvent, selon la destination ou !'utilisation finales du produit, Elgalement etre soumises a autorisation.

ExQort classification AL: 0E001 ECCN: 0E001 Goods labeled with "AL not equal to W are subject to European or GeITTian export authorization when being exported within or out of the EU. Goods labeled with "ECCN not equal to N9 are subject to US reexport authorization. Even without a label, or with label *AL: N. or*ECCN: N", authorization may be required due to the SAFETY RELATED DOCUMENT: N final whereabouts and purpose for which the goods are to be used.

ExQortkennzeichnung AL: 0E001 ECCN: 0E001 CHANGE CONTROL RECORDS: France: N Die mil "AL ungleich N" gekennzeichneten Guter unterliegen bei der Ausfuhr aus der EU bzw.

This document, when revised, must be USA: y innergemeinschafflichen Verbringung der europlHschen bzw. deutschen Ausfuhrgenehmigungspflicht. Die mil "ECCN ungleich N" gekennzeichneten GUter unterliegen der US*Reexportgenehmigungspflicht. Auch ohne reviewed or approved by following regions: Germany: N Kennzeichen, bzw. bel Kennzeichen "AL: N" oder"ECCN: N", kann sich eine Genehmigungspflicht, unter anderem durch den Endverb!eib und Veiwendunaszweck der Guler, emeben.

CW01 Rev. 5.4 - 16/02/21

No FS1-0011462 Rev. 8.0 QAP - Quality Plan framatome Handling: None Page 2/13 REVISIONS REVISION DATE EXP LANA TORY NOTES 1.0 06/14/2013 New document 2.0 06/14/2013 Document is being versioned to fix PDF software errors during rendition.

Section 0. corrected '10 CFR 7' to '10 CFR 71' and corrected 'NQA 3.0 4/18/2014 2008 and NQA 2009a' to 'NQA-1 2008 and NQA-1a 2009' Section 1 corrected orqanization title to MS&CI.

Updated entire document to reflect newly issued AREVA NP Integrated 4.0 01/27/2017 Management System Manual which will supersede the FMM upon NRC acceptance of this document.

Updated entire document to reflect new company name, new IMS and 5.0 3/29/2018 correct references in Section 19 and in Apoendix 1.

Section 3 - deleted an extra word "the" in last sentence of first 6.0 6/16/2020 paragraph in this section to improve readability.

Section 5 - Added word "Regulatory" to bullet B; deleted word "nonconformances" and inserted "Failures to comply" in bullet K.

Section 8 - Added word "on" to last sentence in fourth paragraph to improve readability; Added entire section titled "External audits and Surveys - Exigent Conditions" to specify method for allowing extension of 90 day grace period.

Section 16 - Deleted the letter's' in the word 'conditions' in last sentence of third paragraph to improve readability.

Appendix 1 - Added word 'of' in Description for Regulatory Position 71.113 related to 'Document Control' to improve readability. Deleted word 'for' in Description for Regulatory Position 71.117 related to

'Identification and control of materials, parts, and components' to improve readability. Added word 'of in Description for Regulatory Position 71.119 related to 'Control of Special Processes' to improve readability. Changed word 'area' to 'are' and deleted the word 'in' in Description for Regulatory Position 71.123 related to Test Control' to improve readabilitv.

Section 1- Changed reference ANSI/ASME NQA-1 2008 and Addenda 7.0 3/1/2021 ASME NQA-1a 2009 to ANSI/ASME NQA-1 2015 to reflect current revision of Framatome Integrated Management System Manual.

Section 8 - Changed title from "External audits and Surveys - Exigent Condition" to "External audits and Surveys - Extenuating Circumstances" and language in paragraphs below subtitle to align with wording contained in Calloway SER documented in ML20216A681, which Framatome Inc. has opted to implement.

Nature of Change - Revision 3.0 - changed date from "See 1st page 8.0 See cover release date" to "4/18/2014." Nature of Change - Revision 7. 0 -

page changed date from "3/1/2020 to 3/1/2021" to reflect the correct year document was prepared and entered into Workflow.

Removed Proprietary Header and Footer from document as these markings are incompatible with the document attribute "Handling",

selected on the cover paqe "None."

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No FS1-0011462 Rev. 8.0 QAP - Quality Plan framatome Handling: None Page 3/13 TABLE OF CONTENTS

1. INTRODUCTION ...............................................................................................................................4
2. ORGANIZATION ...............................................................................................................................4
3. QUALITY ASSURANCE PROGRAM ................................................................................................5
4. DESIGN CONTROL ...........................................................................................:..............................5
5. PROCUREMENT DOCUMENT CONTROL ...........................................................,...........................5
6. INSTRUCTIONS, PROCEDURES, AND DRAWINGS ......................................................................6
7. DOCUMENT CONTROL ...................................................................................................................6
8. CONTROL OF PURCHASED MATERIALS, ITEMS AND SERVICES .............................................6
9. IDENTIFICATION AND CONTROL OF MATERIAL, PARTS AND COMPONENTS ....................... 8
10. CONTROL OF SPECIAL PROCESSES ...........................................................................................8
11. INSPECTION .....................................................................................................................................8
12. TEST CONTROL ...............................................................................................................................9
13. CONTROL OF MEASURING AND TEST EQUIPMENT ...................................................................9
14. HANDLING, STORAGE, AND SHIPPING ........................................................................................9
15. INSPECTION, TEST, AND OPERATING STATUS ..........................................................................9
16. CONTROL OF NONCONFORMING ITEMS ...................................................................................10
17. CORRECTIVE ACTION ...................................................................................................................10
18. QUALITY ASSURANCE RECORDS ..............................................................................................10
19. AUDITS ............................................................................................................................................10 LIST OF APPENDICES Appendix 1: For Information Only - Framatome IMS Implementing Procedures Matrix ........................ 12 Framatome - Fuel This document is sub'ect to the restrictions set forth on the first or title a e

N* FS1-0011462 Rev. 8.0 QAP - Quality Plan 1framatome Handling: None Page 4/13

1. INTRODUCTION The Framatome Fuel Business Unit employs an Integrated Management System (IMS) to ensure all applicable quality and regulatory requirements are implemented and met while performing activities. This IMS is defined and specified in the Framatome Integrated Management System (IMS) Manual (D02-ARV-01-101-817). The Framatome IMS manual implements a Management System compliant with 10 CFR 50, Appendix B; 10 CFR 71, Subpart H; and ANSI/ASME NQA-1 2015.

This Quality Assurance Program Description (QAPD) describes all of the Framatome IMS provisions in place to ensure compliance with 10 CFR 71, Subpart H. These provisions are applicable to all activities associated with the design, procurement, fabrication, handling, shipping, cleaning, assembly, inspection, testing, use, maintenance, and modification of components of approved containers used to ship radioactive materials that fall under the jurisdiction of 10 CFR Part 71 Subpart H.

This QAPD does not specify additional requirements or supersede requirements specified in the Framatome IMS manual, but merely provides a description of the requirements applicable to 10 CFR 71, Subpart H work contained in the Framatome IMS manual.

The QAPD appliel'? to the following Framatome locations and other service locations when required by customer contract provisions:

Framatome Inc.

2101 Horn Rapids Road Richland, WA 99354 The Framatome Management System is comprised of the Framatome Integrated Management System Manual and associated implementing procedures. The Framatome implementing procedures are designed and administered to meet the applicable requirements of 10 CFR Part 71, Subpart H; 10 CFR Part 50, Appendix B; and ANSI/ASME NQA-1 2015.

2. ORGANIZATION The Framatome organizational structure, functional responsibilities, levels of authority, and lines of communication for activities affecting quality, safety and environment described within this QAPD are defined within the Framatome IMS manual, implementing documents and organizational charts.

The responsibilities and authority for the Framatome IMS are defined in the Framatome IMS manual. The Framatome organizational charts and corresponding job descriptions define job titles as well as respective duties and responsibilities.

The Richland Site Manager has the ultimate responsibility for ensuring the Richland site operations utilizing special nuclear material (SNM) are conducted in a manner that is protective of its workers, the public and the surrounding environment, and remain in compliance with applicable Federal, State and local regulations, licenses and permits. This is accomplished by putting in place an on-site organization with defined accountabilities and assuring that the organization is given the authority and resources to meets it objectives.

The US Fuel Management System and Continuous Improvement (MS&CI) Manager is vested with the authority to ensure that activities affecting quality are performed and documented in accordance with established requirements. The MS&CI Manager is independent and has no direct responsibilities for product design, engineering services, and/or production.

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No FS1-0011462 Rev. 8.0 QAP - Quality Plan 1framatome Handling: None Page 5/13 Qualified personnel perform monitoring activities and verification of regulatory, contractual and/or technical requirements in accordance with controlled documents.

3. QUALITY ASSURANCE PROGRAM The Management System described by this QAPD is defined in the Framatome Integrated Management System Manual. The hierarchy of documents used to implement the IMS is defined within the Framatome IMS manual and uses common procedures and requirements wherever possible. These documents define the requirements to effectively and efficiently implement the requirements of 10 CFR 71 Subpart H to comply with codes, standards, regulatory and contract requirements.

Activities within this scope of the Framatome IMS include design, procurement, fabrication, handling, shipping, cleaning, assembly, inspection, testing, use, maintenance, and modification of components of approved containers used to ship radioactive materials and regulated under 10 CFR 71 Subpart H.

Framatome complies with 10 CFR Part 21.

The Framatome hierarchy of documents provides for the planning and execution of activities affecting quality under suitably controlled conditions and ensures the provided prerequisites for the given activities are satisfied. Procedures have been established to ensure personnel are properly trained to achieve and maintain the required level of competence to perform activities affecting quality.

4. DESIGN CONTROL Framatome has established procedures to control design and licensing activities to ensure that:

A. Design and licensing activities are planned, controlled, and documented.

B. Regulatory requirements, stakeholders' requirements, design bases and appropriate quality, environmental and safety standards are correctly translated into design and procurement documents.

C. Qualified personnel independently review design documents for completeness and technical accuracy. Verification methods may include independent review of design documents and design analyses or design verification testing.

D. Design interface controls are established and adequate to ensure the appropriate design, organizational and technical interfaces are considered.

E. Design and development changes are identified, documented and controlled in the same manner as the original documents.

F. Design errors and nonconformances are documented and corrected.

G. Design organization(s) and their responsibilities and authorities are defined and controlled through written procedures.

5. PROCUREMENT DOCUMENT CONTROL Procedures have been established to ensure that procurement documents are prepared to clearly define the requirements of the IMS, including requirements specified in customer contracts, regulatory standards or legal requirements.

Procurement activities are performed in accordance with procedures that establish requirements for preparation, review, approval and control of procurement documents. Changes to procurement documents are subject to the same review and approval as the original documents.

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No FS1-0011462 Rev. 8.0 QAP - Quality Plan framatome Handling: None Page 6/13 Procedures have been established to assure the assignment of quality requirements for the procurement of items or services important to safety or safety related. These procedures assure the procurement documents specify the scope of procurement, and include the following:

A Technical requirements, B. Quality, Safety, Regulatory and/or Environmental requirements, C. Right of access to supplier facilities for source inspection and/or audit, D. Inspection and Test requirements, E. Requirements specifying supplier must flow down requirements to sub-tier suppliers, F. Special process requirements, G. Documents required for submittal for Framatome review and/or approval, H. Documentation requirements such as inspection and test records, certification documents, I. Record retention requirements, J. Reporting and disposition of nonconformances, and K. Reporting defects and failure to comply per the requirements of *10 CFR Part 21

6. INSTRUCTIONS, PROCEDURES, AND DRAWINGS Procedures have been established to ensure the activities affecting quality are controlled in accordance with appropriate instructions, procedures and design documents necessary for complying with the IMS requirements for items and services classified as important to safety or safety related.

Changes to instructions, procedures and/or design documents receive the same level of review and approval as the original.

Compliance with approved instructions, procedures and design documents is mandatory for all performance of work activities in accordance with the IMS and implementing procedures.

7. DOCUMENT CONTROL Procedures have been established to control the issuance of documents that prescribe requirements for activities affecting quality associated with items or services classified as important to safety or safety related. These procedures ensure adequate preparation, review, approval, distribution, release, use and revision of documents.

Measures are taken to ensure that only current documents are available at the locations where documents are used. These measures include the control of electronic data bases used to control documents.

Changes to documents are reviewed and approved by the same organizations that reviewed and approved the original.

8. CONTROL OF PURCHASED MATERIALS, ITEMS AND SERVICES Procedures have been established to ensure purchased material, equipment and services conform to procurement documents.

Procurement documents are reviewed and approved by authorized personnel for acceptability of proposed suppliers based on the classification of the item being purchased.

Approved suppliers are listed on the Framatome Approved Supplier List Fuel (ASL) for items and services they provide. The ASL is controlled in accordance with approved procedures.

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No FS1-0011462 Rev. 8.0 QAP - Quality Plan i=ramatome Handling: None Page 7/13 Procedures have been established to ensure suppliers are adequately selected and evaluated according to the importance of the purchased item or service. These evaluations are based on one or all of the following criteria:

a. Supplier's third party certificates and references.
b. Evaluation of the ability of the supplier's quality program to meet the technical and quality requirements applicable to the scope of work.
c. Review of previous records to establish past performance of the supplier.
d. Review of supplier's facility, technical equipment and/or personnel.

Qualified personnel perform supplier audits and surveys. Audit and survey results are maintained as a quality record. Suppliers are assessed at planned intervals to verify compliance with quality requirements and to assess continued effectiveness of their QA program.

External Audits and Surveys - Extenuating Circumstances An overall 25% extension (9 months) for triennial audits or surveys may be exercised during periods where performance of such activities is not feasible as a result of extenuating circumstances. Examples of extenuating circumstances would include, but are not limited to:

1) Declaration of a national emergency;
2) Severe localized or national weather conditions, or damage to Framatome facilities or supplier infrastructure; or
3) Localized outbreak of a severe health concern to the public and Framatome.

Continued use of suppliers that have exceeded the maximum allowed audit or survey time due to extenuating circumstances is allowed if the following conditions are met:

a) A documented evaluation must be performed to summarize why the audit or survey could not be performed prior to the end of the 90-day grace period and to provide the basis for maintaining the supplier as an approved supplier during the 25% (9 month) grace period.

While implementing procedures must describe elements to be included in the documented evaluation, the following items should be considered as applicable:

i. For 10 CFR 71 Subpart H suppliers, verification that the supplier's quality assurance program is still committed to meeting the requirements of 10 CFR 71 Subpart H.

ii. For commercial suppliers who are approved based on commercial grade survey, verification the supplier has maintained adequate programmatic controls in place for activities affecting the critical characteristics of the items/services being procured.

iii. Evaluation of any significant open issues with the NRC, 10CFR21 Notifications, and any open findings since the previous triennial audits describing impact on the items/services being procured from that supplier.

iv. Review of procurement history since last triennial audit/survey including receipt inspections results to verify any potential issues. The results of the performance history must be included in the evaluation.

v. The degree of standardization of the items being procured. For instance, suppliers of catalog items which are used across multiple industries with widely accepted good performance histories would be considered good candidates for a 25% (9-month) grace period.
  • b) If concerns are identified during the evaluation, the following mitigating actions may be considered:

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i. Enhanced receiving inspections beyond visual inspections and quality checks.

ii. Identification of any additional requirements / restrictions to be placed on the supplier.

c) For audits/surveys performed using the 25% grace period, the audit/survey shall include a review of activities performed by the supplier since the 36-month audit/survey expiration date.

d) The 25% grace period would only apply to existing suppliers listed on the Framatome Approved Supplier List - Fuel.

e) The 25% grace period is applicable to domestic and international suppliers.

f) For audits performed during exigent conditions, the audit "clock" does not have to reset backwards to the original date the audit or survey should have been performed. The date that the audit or survey is actually performed will be the start of the new triennial audit or survey frequency.

9. IDENTIFICATION AND CONTROL OF MATERIAL, PARTS AND COMPONENTS Procedures have been established for the identification and control of materials, parts and components. These procedures are designed to prevent inadvertent use of incorrect or nonconforming items. Additionally, these procedures are established to indicate the status of inspections and tests of items by appropriate means, from receipt of the item to end use.

Requirements for identification are established during the preparation of design drawings and specifications.

Items having limited shelf or operating life are controlled to prevent their inadvertent use.

10. CONTROL OF SPECIAL PROCESSES Procedures have been established to control special processes such as welding, heat treatment, and nondestructive examination. Special Processes are performed by qualified personnel using qualified procedures in accordance with applicable requirements.

Procedures and personnel qualifications associated with special processes are maintained as Quality Assurance Records.

11. INSPECTION Procedures have been established to verify conformance with specified requirements for accomplishing activities affecting quality.

Inspection/surveillance and process monitoring are both required where either one by itself will not provide assurance of quality.

Inspection and surveillance activities are performed in accordance with procedures and results are documented. Personnel performing inspection and surveillance activities are trained and qualified in accordance with these approved procedures. lnspection(s) and surveillance(s) are performed by individuals other than those who performed or supervised the subject activities.

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No FS1-0011462 Rev. 8.0 QAP - Quality Plan framatome Handling: None Page 9/13 Inspection and surveillance planning includes the determination of hold points, inspection equipment requirements, acceptance criteria, personnel qualification requirements, variable and/or attribute recording instructions, reference documents, and other requirements as applicable.

12. TEST CONTROL Procedures have been established to assure that proof, acceptance and operational tests are controlled by approved written procedures.

Tests are performed by qualified personnel in accordance with approved procedures.

13. CONTROL OF MEASURING AND TEST EQUIPMENT Procedures have been established to ensure that tools, gages, instruments and other measuring and testing equipment (M& TE) used in important to safety or safety related activities are properly controlled, calibrated and adjusted to maintain accuracy within required limits.

Calibration of M& TE is performed in accordance with approved procedures. These procedures include the following requirements:

a. Traceability of calibration standards to national or international standards.
b. Basis of calibration is documented when no national or international standard exists.
c. M&TE is calibrated to the required degree of accuracy, repeatability, and traceability.
d. Calibration intervals are based on required accuracy and stability of the equipment.
e. M& TE calibration status is identified by tag, label or other appropriate means.
f. Nonconforming M&TE are clearly identified and its use prohibited or suitably restricted until repaired or calibrated.
g. Environmental conditions for calibration.
h. Handling and safeguarding of equipment.
i. Use of test hardware.

M&TE used to determine product acceptance that is found to be out of calibration will be removed from service and recalibrated prior to reuse. Furthermore, an evaluation is performed and documented determining acceptability of items inspected or tested using that M& TE since the last acceptable calibration.

14. HANDLING, STORAGE, AND SHIPPING Procedures have been established to ensure that materials, parts, assemblies, spare parts, special tools, and equipment are handled, stored, packaged and shipped in a manner to prevent damage, loss of identity or deterioration.

When necessary, storage procedures address special requirements for environmental protection such as inert gas atmospheres, moisture control and temperature levels, etc.

15. INSPECTION, TEST, AND OPERATING STATUS Procedures have been established to ensure that the inspection, test and operating status of materials, items, structures, systems and components throughout fabrication, installation, operation and testing are clearly indicated by suitable means (e.g. tags, labels, lot cards, followers, etc.).

Bypassing of required inspections, testing or other critical operations is prevented through the use of approved procedures.

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No FS1-0011462 Rev. 8.0 QAP - Quality Plan t=ramatome Handling: None Page 10/13 As appropriate, the operating status of nonconforming, inoperative, or malfunctioning components (e.g. valves, switches, etc.) is indicated to prevent inadvertent operation. The application and removal of status indicators is performed in accordance with approved instructions and procedures.

16. CONTROL OF NONCONFORMING ITEMS Procedures have been established to control items which do not conform to requirements in order to prevent their inadvertent use. These procedures include, as appropriate instructions, for identification, documentation, segregation, disposition, and notification to affected organizations.

Nonconforming items are reviewed, accepted, repaired, reworked, and/or rejected in accordance with applicable procedures.

Rework and/or repair of nonconforming items are inspected with the applicable inspection requirements applied to the original items or as specified in the rework or repair procedures.

Nonconforming conditions are documented in Condition Reports within the Corrective Action Program (CAP) and affected organizations are notified. These condition reports include a description of the nonconformance, disposition of use including technical justification, corrective and/or preventive actions and other supporting evidence in accordance with written procedures.

17. CORRECTIVE ACTION Procedures have been established to ensure conditions adverse to quality, such as nonconforming conditions; unsatisfactory conditions revealed by audit; inspection or surveillance of products; and customer complaints are promptly identified and corrected to prevent recurrence. Such situations are classified by significance level, and are analyzed for root or apparent causes. Results are reported to appropriate levels of management for review and disposition.

Conditions adverse to quality are documented in the CAP and reported to the appropriate level of management. When necessary, follow up is performed to verify corrective action requirements have been completed and are effective in preventing recurrence. Periodically, CAP trends are evaluated and appropriate corrective actions taken.

Compliance with the evaluation and reporting requirements of 10 CFR Part 21 related to defects and noncompliance is controlled in accordance with approved procedures.

18. QUALITY ASSURANCE RECORDS Procedures have been established to ensure the control of quality records, including those prepared by customers and external sources. The purpose of the quality assurance records system is to ensure that documented evidence pertaining to the important to safety or safety related activities is maintained in accordance with Framatome, customer and/or regulatory requirements, as applicable.

Procedures have been established to ensure Quality Assurance Records are identified as to the type of record to be retained and classified as permanent or non-permanent records. The measures also include instructions for filing and archiving of records, as well as preservation, retrieval and disposition.

Records are provided to customers in accordance with contract requirements.

19. AUDITS Procedures have been established to provide a comprehensive system of planned and periodic audits. Audits are performed to verify compliance with all aspects of the IMS. Those areas and Framatome - Fuel This document is sub"ect to the restrictions set forth on the first or title a e

N° FS1-0011462 Rev. 8.0 QAP - Quality Plan t=ramatome Handling: None Page 11/13 activities to be audited, such as design, procurement, fabrication, and inspection and testing of storage/transportation systems, are identified in audit planning.

Audits are planned and scheduled in a manner to provide coverage and coordination with ongoing Management System activities commensurate with the status and importance of the activities.

Audits are performed by trained and qualified personnel not having direct responsibilities in the areas being audited and are conducted in accordance with approved procedures. Audit results are documented and reviewed with the appropriate level of management having the responsibility for the area audited. Audit reports include an objective evaluation of the quality-related practices, procedures, and instructions for the areas or activities being audited and of the effectiveness of the implementation.

Responsible management undertakes corrective actions as a follow-up to audit reports when appropriate. Audit results are evaluated for indications of adverse trends that could affect quality.

When results of such assessments so indicate, appropriate corrective actions are implemented.

Follow-up of actions including re-audit of deficient areas are performed when determined necessary to ensure corrective actions taken are effective.

Requirements for audit of supplier activities are provided in Section 8 of this QAPD.

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N* FS1-0011462 Rev. 8.0 QAP - Quality Plan 1=ramatome Handling: None Page 12/13 Appendix 1: For Information Only - Framatome IMS Implementing Procedures Matrix Implementing Document Title Regulatory Description Position IMS Section 2, Framatome Organization 71.103 Identifies the QA organization, its Organization and its Context relationship to other organizations within the IMS Section 4.5, Organizational company, and its responsibilities for Roles, Responsibilities, and activities affecting quality.

Authorities QAP-01 IMS Section 3, Framatome Quality 71.101 & Describes the method for establishment and Integrated Management System Assurance 71.105 implementation of a documented Integrated IMS Section 4.5.2, Responsibility Requirements Management System to meet the and Authority for the IMS and Quality requirements of Subpart H of 10CFR71 and Assurance identifies the activities to which it applies.

IMS Section 7, Resources Program Management All Listed QA Procedures IMS Section 8.4, Design and Package 71.107 Describes the design control measures Development of Products and design control established to for structures, systems and Services components.

QAP-04 IMS Section 8.5, Purchasing Procurement 71.109 Describes the measures established to QAP-06 document ensure the necessary technical and quality control requirements are included or referenced in procurement documents for items and services.

IMS Section 8.7, Control of Instructions, 71.111 Describes the measures established to Products and Services procedures, assure items important to safety or activities All Listed QA Procedures and drawings affecting quality are prescribed by, and performed in accordance with documented instructions, procedures, or drawings.

IMS Section 3.2, System Document 71.113 Describes the measures established to Documentation Management Control ensure control of the issuance of documents IMS Section 3.4, Control of QHSE that prescribe requirements for activities Records affecting quality associated with items or services classified as important to safety or QAP-05 safety related.

IMS Section 8.5, Purchasing Control of 71.115 Describes the measures established to QAP-06, QAP-07 purchased ensure the procurement of items or services material, classified as important to safety or safety equipment, related conforms to specified requirements.

and services Measures include source selection and evaluation, source inspection, audit, and receipt inspection of items or services upon delivery or completion.

IMS Section 8.7.5, Identification, Identification 71.117 Describes the measures established to Traceability, Inspection and and control of ensure the identification and control of Status Control materials, materials, parts and components from receipt QAP-08 parts, and to end use.

components IMS Section 8.7.1, Qualification or Control of 71.119 Describes the measures established to Validation of Production and Special ensure control of special processes in Service Processes Processes accordance with specified requirements.

QAP-09 Framatome - Fuel This document is sub*ect to the restrictions set forth on the first or title a e

FS1-0011462 Rev. 8.0 QAP - Quality Plan 1:ramatome Handling: None Page 13/13 IMS Section 8.7.2, Inspections Internal 71.121 Describes the measures established to QAP-10 inspection ensure inspections required to verjfy conformance with specified requirements are accomplished.

IMS Section 8.7.5, Identification, Test Control 71.123 Describes the measures established to Traceability, Inspection and ensure tests are controlled and performed by Status Control qualified personnel with written procedures.

QAP-10 IMS Section 8.7.6, Control of Control of 71.125 Describes the measures established to Measuring and Test Equipment measuring and ensure measuring and test equipment used QAP-11 test equipment in important to safety or safety related activities are controlled, calibrated and adjusted to the accuracy required.

IMS Section 8.7.7, Preservation of Handling, 71.127 Describes the measures established to the Product storage, and ensure products handled, stored, or shipped QAP-15 shipping are maintained to preserve the quality of the control product.

IMS Section 8.7.5, Identification, Inspection, 71.129 Describes the measures established to Traceability, Inspection and Testing, and ensure that the inspection, test and operating Status Control Operating status of items are clearly indicated by QAP-08 Status suitable means.

IMS Section 8.8, Control of Nonconforming 71.131 Describes the measures established to Nonconforming Products and materials, ensure product which to do not conform to Services parts, or requirements are controlled to prevent their QAP-13 components inadvertent use.

IMS Section 10.2, Corrective Corrective 71.133 Describes the measures established to Actions Action ensure that conditions adverse to quality are QAP-13 promptly identified and corrected to prevent recurrence.

IMS Section 3.4, Control of QHSE QA Records 71.135 Describes the measures established to Records ensure the control of quality records related QAP-16 to important to safety or safety related activities.

IMS Section 9.2, Audit and Audits 71.137 Describes the measures established to Independent assessment ensure internal and external audits are QAP-17 performed.

Framatome - Fuel I This document is subiect to the restrictions set forth on the first or title oaae

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