ML21230A319

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Louisiana Energy Services, LLC, Dba Urenco USA, Quality Assurance Program Description (QAPD) Update
ML21230A319
Person / Time
Site: 07100940
Issue date: 08/16/2021
From: Padgett W
Louisiana Energy Services, URENCO USA
To:
Document Control Desk, Office of Nuclear Material Safety and Safeguards
References
LES-21-089-NRC
Download: ML21230A319 (28)
v • d • e


Text

LES-21-089-NRC 8/16/21 Attn: Document Control Desk Director, Division of Spent Fuel Management Office of Nuclear Material Safety and Safeguards U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 Louisiana Energy Services, LLC NRC Docket No. 71-0940

Subject:

Quality Assurance Program Description (QAPD) Update SA In accordance with 10 CFR Part 71.106(b). Louisiana Energy Services, LLC ("LES"), also dba URENCO USA ("UUSA"), is submitting the non-substantive changes of the Quality Assurance Program Description (QAPD) to the NRC within the 24-month requirement.

The changes to the Quality Assurance Program Description (QAPD), revisions 42, 42a, 43, 43a and 43b are provided in Enclosure 1. Revision bars, strikethroughs and underlines were utilized, a description of the change is provided in the revision summary of the QAPD for each revision.

Should there be any questions regarding this submittal, please contact me at 575-394-5257.

Respectfully, Wyatt Padgett Wyatt Padgett C Digitally signed by Wyatt

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/ _Date; 2021.08.16 08:29:54

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Compliance and Licensing Manager.

Quality Assurance Program Description (QAPD), Rev. 42, 42a, 43, 43a and 43b Louisiana Energy Services, LLC UUSA I P.O. Box 1789 I Eunice J New Mexico i 88231 I USA T: +1 (575) 394 4646 I W: www.uusa.urenco.com

© 2021 Louisiana Energy Services, LLC

CC: email Matt Bartlett U.S. Nuclear Regulatory Commission NMSS/DFM/FFLB Matthew. Bartlett@nrc.gov Jon Woodfield U.S. Nuclear Regulatory Commission NMSS/DFM/108 Jon.Woodfield@nrc.gov Jacob Zimmerman U.S. Nuclear Regulatory Commission NMSS/DFM/FFLB Jacob.Zimmerman@NRC.gov Robert Williams U.S. Nuclear Regulatory Commission R-11/DFFI/PB 1 Robert.Williams@nrc.gov

ENCLOSURE 1 Quality Assurance Program Description (QAPD), Rev. 42, 42a, 43, 43a and 43b

QUALITY ASSURANCE PROGRAM DESCRIPTION Revision 42-1--

42 Summary of Changes for Revision 4442 Added responsibilities and position description for Deputy LBDCR-20-010 Compliance Manager CC-LS-2020-0001:

70.72 -2020-295 Quality Assurance Program Description Revision '1-+----------2 I

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SECTION 1 Organization During the design and construction phases, preparation of design and construction documents and construction itself were contracted to qualified contractors. The Head of Technical Services was responsible for managing the associated activities including the construction work and contracts, design and engineering up to and through construction turnover and final acceptance.

Final acceptance was performed by the Head of Operations, Head of Technical Services or Head of Compliance depending on which structure, system or components was included as part of the turnover within their respective responsibilities. Upon final acceptance, the responsibility for site Design Authority also transferred from Head of Project Engineering to the Head of Technical Services. The Procurement Manager was responsible for coordinating procurements using qualified contractors or UUSA personnel to support both project construction and operations' needs. Contractor QA Programs were reviewed by the UUSA QA organization and approved by the UUSA QA Manager before work was started.. URENCO designed, manufactured and delivered to the site the centrifuges necessary for the facility under a QAPD approved by the UUSA QA Manager or under the UUSA QAPD. In addition, URENCO supplied the technical assistance and consultation for the facility in accordance with the applicable requirements of the UUSA QAPD.

OPERATING ORGANIZATION AND FUNCTIONS The operating organization is shown in Figure 2.1-2 of the SAR, URENCO USA (UUSA) Operating Organization. The Operations Manager, Engineering and Projects Manager, Maintenance Manager, Logistics Manager, Decommissioning, Decontamination and Recycling Manager_,_ -aAG-Compliance Manager, Deputy Compliance Manager, and Shift Managers functio'ning as the Chief Nuclear Officer, are responsible for ensuring the facility complies with all applicable regulatory requirements including the requirements of this QAPD. Section 2.1.3, Operating Organization, of the SAR describes the reporting chain, responsibilities and activities.

Procedures are developed by designated organizations to implement the requirements of the QAPD. Organizational responsibilities are provided within Section 2 of the URENCO USA (UUSA) Safety Analysis Report.

QA ORGANIZATION AND FUNCTIONS The UUSA QA organization has been established to verify the effectiveness of the implementation of quality activities during the design, construction, testing, operations, and decommissioning phases of the enrichment facility. The QA organization is headed by the UUSA QA Manager.

The UUSA QA Manager reports to the Compliance Manager. The QA Manager is specifically provided stop work authority at the Chief Nuclear Officer and President level for Quality Assurance issues. As described in Chapter 2 of the SAR, the Operations Manager and the Chief Nuclear Officer are responsible for operations activities and is thus a high enough level to authorize a stop work. In addition, the President is ultimately responsible for all procurement quality, construction and design. The QA Manager has a direct relationship with the President for quality concerns. This ensures the QA Manager has sufficient independence for all issues affecting quality.

Quality Assurance Program Description Revision 42_4 Page I 3

QUALITY ASSURANCE PROGRAM DESCRIPTION Revision 42a i1:s,.,.:~a:~i,tr17sg:,; eun1~j.N****.:.:.ew,'./.,.*

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Summary of Changes for Revision 42a42 LBDCR 20 01 0 Complianoe Manager CC LS 2020 0001; 70.72 2020 295 LBDCR 20_016 Removed responsibilities and position description for Deputy Compliance Manager Adoption of UUSA NQA-1 2015 Requirement 17 and LBDCR 20_019 associated subparts 3.1-17.1 and 3.1-17.2 which will supersede the requirements of NQA-1 1994 CC-LS-2020-0003 Quality Assurance Program Description Revision 42a42

Introduction INTRODUCTION Louisiana Energy Services (UUSA) maintains full responsibility for ensuring that the enrichment facility is designed, constructed, operated, and decommissioned in conformance with applicable regulatory requirements, specified design requirements, applicable industry standards and good engineering practices in a manner to protect the health and safety of the employees and the public. To this end, the UUSA Quality Assurance Program conforms to the criteria established in Title 10 of the Code of Federal Regulations 10 CFR 50, Appendix 8, Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants. The program also satisfies the requirements of Title 10 of the Code of Federal Regulations, Part 71, Subpart H, Quality Assurance for Packaging and Transportation of Radioactive Material. The criteria in 10 CFR 50, Appendix 8 and 10 CFR 71 Subpart H, are met by UUSA's commitment to follow the guidelines of the American Society of Mechanical Engineers (ASME) Quality Assurance (QA) standard NQA 1-1994, Quality Assurance Program Requirements for Nuclear Facilities, including supplements as revised by the ASME NQA-1 a-1995 Addenda. UUSA has additionally adopted NQA-1, 2015 Requirement 17 Quality Assurance Records. The program also includes in QAPD Section 16 the use of Corrective Action Program for Safety and Security events (ref LBDCR 0042). See Section 4 Procurement Document Control for specific UUSA exemptions to 10 CFR Part 21.3 for the definitions of "commercial grade item", "basic component", "critical characteristics", "dedicating entity", and "dedication".

As described in Section 19, Provisions for Change, subsequent changes to the UUSA QA

.Program that shall be incorporated in this QAPD. Any changes that reduce the commitments in the approved QAPD will be submitted to the Nuclear Regulatory Commission (NRC) for review and approval prior to implementation.

Quality Assurance Program Description Revision 42a~

Page I 1

SECTION 1 Organization During the design and construction phases, preparation of design and construction documents and construction itself were contracted to qualified contractors. The Head of Technical Services was responsible for managing the associated activities including the construction work and contracts, design and engineering up to and through construction turnover and final acceptance.

Final acceptance was performed by the Head of Operations, Head of Technical Services or Head of Compliance depending on which structure, system or components was included as part of the turnover within their respective responsibilities. Upon final acceptance, the responsibility for site Design Authority also transferred from Head of Project Engineering to the Head of Technical Services. The Procurement Manager was responsible for coordinating procurements using qualified contractors or UUSA personnel to support both project construction and operations' needs. Contractor QA Programs were reviewed by the UUSA QA organization and approved by the UUSA QA Manager before work was started.. URENCO designed, manufactured and delivered to the site the centrifuges necessary for the facility under a QAPD approved by the UUSA QA Manager or under the UUSA QAPD. In addition, URENCO supplied the technical assistance and consultation for the facility in accordance with the applicable requirements of the UUSA QAPD.

OPERATING ORGANIZATION AND FUNCTIONS The operating organization is shown in Figure 2.1-2 of the SAR, URENCO USA (UUSA) Operating Organization. The Operations Manager, Engineering and Projects Manager, Maintenance Manager, Logistics Manager, Decommissioning, Decontamination and Recycling Manager, Compliance Manager, Deputy Complianoe Manager, and Shift Managers functioning as the Chief Nuclear Officer, are responsible for ensuring the facility complies with all applicable regulatory requirements including the requirements of this QAPD. Section 2.1.3, Operating Organization, of the SAR describes the reporting chain, responsibilities and activities.

Procedures are developed.by designated organizations to implement the requirements of the QAPD. Organizational responsibilities are provided within Section 2 of the URE NCO USA (UUSA) Safety Analysis Report.

QA ORGANIZATION AND FUNCTIONS The UUSA QA organization has been established to verify the effectiveness of the implementation of quality activities during the design, construction, testing, operations, and decommissioning phases of the enrichment facility. The QA organization is headed by the UUSA QA Manager.

The UUSA QA Manager reports to the Compliance Manager. The QA Manager is specifically provided stop work authority at the Chief Nuclear Officer and President level for Quality Assurance issues. As described in Chapter 2 of the SAR, the Operations Manager and the Chief Nuclear Officer are responsible for operations activities and is thus a high enough level to authorize a stop work. In addition, the President is ultimately responsible for all procurement quality, construction and design. The QA Manager has a direct relationship with the President for quality concerns. This ensures the QA Manager has sufficient independence for all issues affecting quality.

Quality Assurance Program Description Revision 42a42--

Page 13

SECTION 17 Quality Assurance Records SECTION 17 QUALITY ASSURANCE RECORDS The elements of the UUSA QA Program described in this section and associated QA procedures implement the requirements of Criterion 17, Quality Assurance Records, of 10 CFR 50, Appendix 8, and the commitm.ent to NQA-1, 2015-BasiG-Requirement 17 and Supplement 17S 1 of NQA 11994 Part I.

A QA record is any completed record that furnishes documentary evidence that items or activities meet specified quality requirementsof the quality of items and/or activities affecting quality. Records may include specially processed records such as radiographs, photographs, negatives, microforms and magnetic/electronic media. UUSA completed QA records that furnish documentary evidence of quality shall be specified, prepared and maintained in accordance with applicable regulatory requirements and applicable procedures. QA Records shall be identified, generated, authenticated, and maintained, and their final disposition specifiedlegible, identifiable, retrievable, and shall be protected against damage, deterioration and loss. Requirements and responsibilities for record transmittal, distribution, retention, maintenance and disposition shall be established and documented in procedures. Retention periods for the various types of records generated under the UUSA QA Program shall be specified as Lifetime or Nonpermanent according to the criteria provided in this Section. The term "records" used throughout this section is to be interpreted as "Quality Assurance Record,"

unless otherwise specified.

RECORD MANAGEMENT SYSTEM UUSA shall establish a record management system and UUSA Records Center at the earliest practicable time consistent with the schedule for accomplishing work activities and in compliance with the requirements of this QAPD. The QA records management system shall be defined, implemented and enforced in accordance with written procedures, instructions or other documentation. Records shall be distributed, handled, and controlled in accordance with written procedures.

GENERATION, CLASSIFICATION AND RETENTION OF QA RECORDS Applicable UUSA design specifications, procurement documents, test procedures, operational procedures or other documents and procedures shall specify the records to be generated, supplied or maintained. Documents that are designated to become records shall be legible, accurate and completed appropriate to the work accomplished. UUSA records shall be classified for retention purposes as lifetime records or nonpermanent records in accordance with the criteria provided below.

Lifetime records are those that meet one or more of the following criteria:

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Those which would be of significant value in demonstrating capability for safe operation;

-e-Those which would be of significant value in maintaining, reworking, repairing, replacing or modifying an item; Those which would be of significant value in determining the cause of an accident or malfunction of an item; and/or Those which provide required baseline data for in-service inspections.

Quality Assurance Program Description Revision 4-6.4 Page 144

SECTION 17 Quality Assurance Records Lifetime records are required to be maintained for the life of the particular item while it is installed in the facility or stored for future use.

Nonpermanent records are those required to show evidence that an activity was performed in accordance with the applicable requirements of the UUSA QA Program but need not be retained for the life of the item because they do not meet the criteria for lifetime records. The retention period for nonpermanent records shall be documented in the applicable procedure.

Procedures shall identify those documents that will become QA records. The individual using the procedure is responsible for ensuring the QA records required by the procedure are submitted to the UUSA Records Center. Documents that may become records shall be maintained and processed in a prudent manner to avoid unnecessary delay and/or expense in retrieving the record when the record is needed to support other work.

Individuals creating records shall ensure the records are legible, accurate and complete, and shall protect them from damage, deterioration or loss during the time the records are in their possession.

AUTHENTICATION OF QA RECORDS Documents shall be considered valid records only if authenticated (h&.;- stamped, initialed or signed and dated complete by authorized personnel. Corrections to documents shall be reviewed and approved by the responsible individual from the originating or authorized organization. If the nature of the record precludes stamping or signing, then other means of authentication by authorized personnel is permitted.

This may take the form of a statement by the responsible individual or organization.

Provisions for the authentication of electronic records should provide for the use of automated systems for the identification and signature recognition of the personnel performing the record authentication. An electronic signature is a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to represent the individual's handwritten signature. If electronic codes or user account information (e.g.. username and password) is used for identification, controls should be established to ensure traceability to the authenticating individual or organization. Consideration should be given to periodically requiring the establishment of new user passwords. Methods for authenticating electronic records should be reliable and generally equivalent to paper records and handwritten signatures executed on

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Electronic signatures that are not based on biometrics should employ at least two distinct verification components such as user identification and password. Electronic signatures based upon biometrics should be controlled to ensure that they cannot be used by anyone other than the legitimate owners. The integrity of the records in the new system or media should be verified. It is recommended that a not easily alterable format be used to ensure that the content.

context. and structure are maintained consistent with the original record copy. If use of a not easily alterable format is not practical, controls should exist to provide an equivalent level of control. When a record is converted to electronic media, the authentication of that record does not need to be reperformed.

Handwritten signatures are not required if the document is clearly identified as a statement by the reporting individual or organization. QA records may be originals, copies or electronically Quality Assurance Program Description Revision 4Z.4-Page I 45

SECTION 17 Quality Assurance Records generated. UUSA contractors shall submit to the UUSA Records Center those records being temporarily stored by them in accordance 1Nith contraotual requirements. The timing of the submittal shall be as records become completed, or as items are released for shipment, or as prescribed by QA procedures and procurement documents. Records shall be controlled and submitted to the records management system in accordance with implementing procedures.

RECEIVING, STORING, SAFEKEEPING AND PRESERVING QA RECORDS A process shall be provided within approved procedures, which provides the requirements for receiving, storing, safekeeping and preserving QA records as defined within Supplement 17S 4Requirement 17 of NQA-1-4QQ4..2015 Part 1, Subpart 3.1-17.1 and Subpart 3.1-17.2. In addition, the storage process for electronic QA records shall be provided within approved procedures requiring both media and compatible processing systems which ensure a retrievable and legible format for the entire retention period of the record. Responsibilities for implementing the processes shall be defined. Electronic records should be indexed to provide for the timely retrieval of the record. External indexing includes the labeling of records stored on external off-line media. External labeling should be developed and attached to the media used.

Internal indexing of electronic records should enable the user to identify and access a specific record by using a table of contents, directory, key word, or other index strategy. In some cases the index may be automatically created by the system, while in other cases the originator may generate it. Where the originator creates the index, provisions should be established to ensure that all indices are identified using a common naming convention.

UUSA RECORDS CENTERS Originating organizations shall store records in temporary storage while active and required for use; subsequently the records shall be transmitted for permanent storage in accordance with the requirements of this Section and associated procedures.

UUSA organizations shall provide for temporary storage of records during processing, review or use, until turnover to the UUSA Records Center for disposition, according to implementing procedures and the following requirements:

Records shall be temporarily stored in a iR--a-container or facility thatwitA--a provides a one-hour fire rating unless dual storage requirements are met. of one (1) hour. The temporary storage container or facility shall bear an Underwriters' Laboratories label (UL) (or equi¥alent) certifying one (1) hour fire protection, or be sertified by a person sompetent in the technical field of fire protection.

The maximum time limit for keeping records in temporary storage shall be specified by implementing procedures consistent with the nature or scope of work.

UUSA QA records permanent storage shall either invoke the alternate single storage facility provision of Section 4-,4,-2602.1 and/or the dual facilities provision of Section 44.4602.2 of Supplement Requirement 17S-4 of NQA-1-20154994. With either provision used, the UUSA Records Center shall be constructed and maintained in a manner that minimizes the risk of loss, damage or destruction from the following:

Natural disasters ~such as winds, floods or fires};

Quality Assurance Program Description Revision 464 Page 146

SECTION 17 Quality Assurance Records Environmental conditions ~such as high and low temperatures and humidity}; aoo

_o _Infestation of insects, mold or rodents and Dust or airborne particles""

If the alternate single storage facility provision is used, then UUSA records shall be stored in the UUSA Records Center in two (2) hour fire rated Class B file containers meeting the requirements of National Fire Protection Association (NFPA) 232 1986 or NFPA 232AM 1986 or both.

If single storage facility provision is used, the records shall be stored in a storage facility, vault, room. or container(s) with a minimum two-hour fire rating. The design and construction of a single storage facility, vault room, or container shall be reviewed for adequacy by a person competent in fire protection or contain a certification or rating from an accredited organization."

If the dual storage facility provision is used, the dual facilities, containers, or a combination thereof shall be at locations sufficiently remote from each other to eliminate the chance exposure to a simultaneous hazard. Facilities used for dual storage are not required to satisfy the requirements of the single storage provision, but must minimize the risk of loss, damage or destruction from the following, natural disasters such as winds: floods or fires: environmental conditions such as high and low temperatures and humidity: Infestation of insects, mold or rodents: and dust or airborne particles. Activities detrimental to the records shall be prohibited in the storage area. Storage for electronic records requires two sets of in-process records should be maintained since the electronic media may be exposed to computer viruses and inadvertent alteration.

If the dual storage facility provision is used for hard copies, then UUSA records shall be stored with one copy in the UUSA Records Center and the second copy stored in facility that is sufficiently remote from the Records Center to eliminate the chance of exposure to a simultaneous hazard. If the dual storage facilities provision is used via scanned documents into an electronic records management system, then a back up tape shall be periodically made of the electronic records management system and its contents and the tape shall be stored in a temporary storage device in a fire proof safe. This process invokes the dual storage provision as one copy resides on the records management system computer and a second copy of the total records system resides in a remote location v,ith temporary storage being used for records entered in the interim.

RETRIEVING AND DISPOSITIONING QA RECORDS The records management system shall provide for retrieval of records in accordance with planned retrieval times based upon the designated record type. Access to records storage facilities shall be controlled. A list shall be maintained designating personnel who are permitted access to the records at the UUSA Records Center.

Records maintained by a supplier at its facility or other location shall be accessible to the purchaser or designated alternate. The supplier's records shall not be disposed of until contractual requirements are satisfied.

Quality Assurance Program Description Revision 4£4 Page I 47

SECTION 17 Quality Assurance Records Records accumulated at various locations prior to transfer shall be made accessible to UUSA directly or through the procuring organization. The record-keeper shall inventory the submittals, acknowledge receipt and process these records in accordance with this QAPD. Various regulatory agencies have requirements concerning records that are within the scope of this Section. The most stringent requirements should be used in determining the final disposition.

The supplier's nonpermanent records shall not be disposed of until the applicable conditions listed below are satisfied.

Items are released for shipment, a Code Data Report is signed, or a Code Symbol stamp is affixed.

Regulatory requirements are satisfied.

Operational status permits.

Warranty consideration is satisfied.

_* _Purchaser's requirements are satisfied.

Storage of electronic records requires both media and compatible processing systems. The media containing the electronic records and the compatible processing systems access should translate the records into an appropriate retrievable. legible format. A typical processing system may consist of a computer and an application program.

The types of media utilized for electronic record storage should be identified in the records management program. The selection of the storage media should consider the shelf life of the media and the manufacturer's recommended qualified life. Electronic records should be migrated onto new media before the manufacturer's recommended useful life is exceeded.

Two sets of electronic records should be maintained to ensure timely recovery in the event they are damaged or lost. These sets may be established in processing systems installed on separate servers, stand-alone computer platforms, or in a removable media format (e.g.. optical disk, floppy disk).

The electronic records system shall ensure the characteristics of content and location are accurately reflected in the metadata associated with electronic records. The electronic records system shall be designed with data search considerations based on the size and purpose of the records program to enable data searching commensurate with the expected retrieval time frames.

Controls for remote access. local access, and secure processing systems should be established to prevent the alteration, damage, or loss of electronic records. Storage procedures for remote and local access systems should include security measures such as user passwords. network firewalls. file encryption, and virus protection. Appropriate environmental controls should be established for each type of electronic media to prevent damage to electronic media from environmental conditions such as light, heat. humidity or electromagnetic fields.

Recommendations from the media manufacturer should be considered in establishing environmental controls. All electronic processing systems should also have power isolation devices to minimize the risk of damage from voltage surges, spikes, and other power-line disturbances.

Quality Assurance Program Description Revision 4i4 Page 148

SECTION 17 Quality Assurance Records If temporary storage for electronic records is used. two sets of in-process records should be maintained since the electronic media may be exposed to computer viruses and inadvertent alteration.

RETENTION OF QA RECORDS Lifetime records shall be retained and preserved for the operating life of the particular item while it is installed in the plant or stored for future use. Nonpermanent records shall not be disposed of until the following conditions are met:

Regulatory requirements are satisfied; Facility status allows document disposal; and UUSA QAPD requirements are satisfied CORRECTING INFORMATION IN QA RECORDS Corrections shall include the identification of the person authorized to make the correction and the date the correction was made. Corrections to records shall be performed in accordance with implementing procedures, which provide for appropriate review or approval of the corrections, by the originating organization.

REPLACING LOST OR DAMAGED QA RECORDS Replacement, restoration or substitution of lost or damaged records shall be performed in accordance with implementing procedures, which provide for appropriate review or approval by the originating organization and any additional information associated with the replacement.

ELECTRONIC RECORDS Electronic records may be generated using several different methods, which may include electronic data, electronic mail and records resulting from the conversion from one media type to another. NQA-1. 2015, Requirement 17, Subpart 3.1-17.1 and Subpart 3.1-17.2 lists the specified requirements relating to the control of electronic quality assurance records management. A process shall be provided within approved procedures which provide the requirements for electronic records authorization by electronic signatures, electronic approvals, or any other means that ensures traceability to a specific individual or organization of authorization with an associated date. The authentication information must be identified on the media or contained within or linked to the document itself.

Quality Assurance Program Description Revision 4i4 Page 149

QUALITY ASSURANCE PROGRAM DESCRIPTION

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Summary of Changes for Revision 43 Removed reference to Figure 2.12 of the SAR.

LBDCR-21 _005 Added schedule extensions up to 25% for external audit/surveillance when under exigent conditions CC-QA-2020-0001 Quality Assurance Program Description Revision 43

SECTION 1 Organization During the design and construction phases, preparation of design and construction documents and construction itself were contracted to qualified contractors. The Head of Technical Services was responsible for managing the associated activities including the construction work and contracts, design and engineering up to and through construction turnover and final acceptance.

Final acceptance was performed by the Head of Operations, Head of Technical Services or Head of Compliance depending on which structure, system or components was included as part of the turnover within their respective responsibilities. Upon final acceptance, the responsibility for site Design Authority also transferred from Head of Project Engineering to the Head of Technical Services. The Procurement Manager was responsible for coordinating procurements using qualified contractors or UUSA personnel to support both project construction and operations' needs. Contractor QA Programs were reviewed by the UUSA QA organization and approved by the UUSA QA Manager before work was started.. URE NCO designed, manufactured and delivered to the site the centrifuges necessary for the facility under a QAPD approved by the UUSA QA Manager or under the UUSA QAPD. In addition, URENCO supplied the technical assistance and consultation for the facility in accordance with the applicable requirements of the UUSA QAPD.

OPERATING ORGANIZATION AND FUNCTIONS The operating organization is shovm in Figure 2.1 2 of the SAR, URENCO USA (UUSA) Operating Organization. The Operations Manager, Engineering and Projects Manager, Maintenance Manager, Logistics Manager, Decommissioning, Decontamination and Recycling Manager, Compliance Manager, and Shift Managers functioning as the Chief Nuclear Officer, are responsible for ensuring the facility complies with all applicable regulatory requirements including the requirements of this QAPD. Section 2.1.3, Operating Organization, of the SAR describes the reporting chain, responsibilities and activities.

LBDCR 21-005 Procedures are developed by designated organizations to implement the requirements of the QAPD. Organizational responsibilities are provided within Section 2 of the URENCO USA (UUSA) Safety Analysis Report.

QA ORGANIZATION AND FUNCTIONS The UUSA QA organization has been established to verify the effectiveness of the implementation of quality activities during the design, construction, testing, operations, and decommissioning phases of the enrichment facility. The QA organization is headed by the UUSA QA Manager.

The UUSA QA Manager reports to the Compliance Manager. The QA Manager is specifically provided stop work authority at the Chief Nuclear Officer and President level for Quality Assurance issues. As described in Chapter 2 of the SAR, the Operations Manager and the Chief Nuclear Officer are responsible for operations activities and is thus a high enough level to authorize a stop work. In addition, the President is ultimately responsible for all procurement quality, construction and design. The QA Manager has a direct relationship with the President for quality concerns. This ensures the QA Manager has sufficient independence for all issues affecting quality.

Quality Assurance Program Description Revision 43 Page 13

SECTION 18 Audits LBDCR 21-005 the original audit started. The provision for audit start date extension shall also apply !Q_supplier external audits, commercial grade surveys and evaluations.

A maximum extension not to exceed 90 days for external audits shall be allowed unless exigent conditions exist Under exigent conditions, the supplier audit and/or survey interval may be extended up to 25% (275 days). This unique grace period can be applied if exigent conditions exist including but not limited to; a) declaration of a national emergency, b) severe localized or national weather conditions, or c) localized outbreak of a severe health concern to the public.

Under these exigent conditions the audit clock resets when the audit and/or survey is performed. The 25% grace period extension is applicable to domestic and international suppliers.

During the use of the 25% extension, a supplier evaluation shall be performed and results documented, including any necessary qualification adjustments. Suppliers in the 25% extension can be maintained on the UUSA ASL provided the following actions (a - c) are taken and the results satisfactory:

a. Verification that;
1) the supplier is still implementing a quality assurance program that meets Appendix B to 10 CFR Part 50 OR
2) commercial suppliers surveyed are still maintaining adequate documented programmatic controls for the activities affecting quality.
b. Monitor ongoing and previous supplier performance promptly considering impacts of the following types of information:
1. Results of receipt inspection activities or other operating experience.
2. Review of supplier-furnished documents and records such as certificates of conformance, nonconformance notices, and corrective actions.
3. Results of audits and inspections from other sources (e.g., customer, American Society of Mechanical Engineers (ASME); NIAC audits or NRC inspections)

In the case of a new procurement activity or changes to existing procurements that significantly enlarges the scope or changes the method / controls for activities performed by the supplier, the evaluation shall document the justification that the change(s) are adequately addressed by the supplier's quality assurance program or mitigating actions are being taken by UUSA.

AUDIT PLANS A documented audit plan shall be developed for each audit. This plan shall identify the audit scope, requirements for performing the audit, type of audit personnel needed, work to be audited, organizations to be notified, applicable documents, audit schedule, and implementing documents or checklists to be used.

AUDIT TEAMS The UUSA QA Manager shall select and assign auditors who are independent of any direct responsibility for performing the work being audited and are capable of auditing the audit scope.

Audit personnel shall have sufficient authority and organizational freedom to make the audit Quality Assurance Program Description Revision 43 Page I 50

QUALITY ASSURANCE PROGRAM DESCRIPTION Revision 43a3

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Summary of Changes for Revision 43a43 LBDCR 21 _008 Editorial change to correct formatting error made in implementation of LBDCR 21-005.

Quality Assurance Program Description Revision 43a43

SECTION 18 Audits audit started. The provision for audit start date extension shall also apply to external audits, commercial grade surveys and evaluations.

A maximum extension not to exceed 90 days for external audits shall be allowed unless exigent conditions exist. Under exigent conditions, the supplier audit and/or survey interyal may be extended up to 25% (275 days). This unique grace period can be applied if exigent conditions exist including but not limited to; a) declaration of a national emergency, b) severe localized or national weather conditions, or c) localized outbreak of a severe health concern to the public.

Under these exigent conditions the audit clock resets when the audit and/or survey is performed. The 25% grace period extension is applicable to domestic and international suppliers.

During the use of the 25% extension, a supplier evaluation shall be performed and results documented, including any necessary qualification adjustments. Suppliers in the 25% extension can be maintained on the UUSA ASL provided the following actions (a - c) are taken and the results satisfactory:

LBD R 21-008

.§,_ Verification that;

.:i+-the supplier is still implementing a quality assurance program that meets Appendix B to 10 CFR Part 50 OR ill 2-}(2) commercial suppliers surveyed are still maintaining adequate documented programmatic controls for the activities affecting quality.

a-Monitor ongoing and previous supplier performance promptly considering impacts of the following types of information:

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b,-Results of receipt inspection activities or other operating experience.

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&.-Review of supplier-furnished documents and records such as certificates of conformance, nonconformance notices, and corrective actions.

@LResults of audits and inspections from other sources (e.g., customer, American Society of Mechanical Engineers (ASME), NIAC audits or NRC inspections)

£:_In the case of a new procurement activity or changes to existing procurements that significantly enlarges the scope or changes the method / controls for activities performed by the supplier, the evaluation shall document the justification that the change(s) are Quality Assurance Program Description Revision 43a4J Page 150

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43.!2 Summary of Changes for Revision 43b43a Revise the QAPD to align requirements for the commercial grade dedication and testing services to NEI 14-05A, Rev 1.

Guidelines for the use of Accreditation in Lieu of Commercial LBDCR 21-011 Grade Surveys for Procurement of Laboratory Calibration and Test Services.

GCP-004 70.72 2021-036 Quality Assurance Program Description Revision 43b~

SECTION 7 Control of Purchased Material, Equipment and Services Commercial Grade Calibration and Testing Services Methods for accepting supplier furnished material, equipment or services shall include one or more of the following, as appropriate to the items or services being procured:

Evaluating the supplier certificate of conformance, Performing one or a combination of source verification, receiving inspection or post installation test, Technical verification of the data produced (services only),

Surveillance or audit of the activities (services only),

Review of objective evidence for conformance to procurement requirements (services only). The supplier shall verify that furnished material, equipment or services comply with UUSA's procurement requirements before offering the material, equipment or services for acceptance and shall provide to UUSA objective evidence that material, equipment or services conform to procurement documents.

Where required by code, regulations or contract provisions, documentary evidence that items conform to procurement documents shall be available at the site prior to installation or use.

CERTIFICATE OF CONFORMANCE When a certificate of conformance is used to accept material, equipment or service:

The certificate shall identify the purchased material, equipment or service to the specific procurement document.

The certificate shall identify the specific procurement requirements met by the purchased material, equipment or service. The procurement requirements identified shall include any approved changes, waivers or deviations applicable to the material, equipment or service.

The certificate shall identify any procurement requirements that have not been met together with an explanation and the means for resolving nonconformances.

The certificate shall be signed and dated or otherwise authenticated by an individual who is responsible for the supplier's quality assurance function and whose responsibilities and position are described in the supplier's quality assurance program.

The certification process, including the implementing documents to be followed in filling out a certificate and the administrative implementing documents for review and approval of the certificates, shall be described in the supplier's quality assurance program.

Measures shall be identified to verify the validity of supplier certificates and the effectiveness of the certification process (such as by audit of the supplier or by an independent inspection or test of the Quality Assurance Program Description Revision 43b4J.a Page I 23 LSDC-21-f 11

SECTION 7 Control of Purchase Material, Equipment and Services COMMERCIAL GRADE CALIBRATION OR TESTING SERVICES When purchasing commercial grade calibration services from domestic or international calibration and testing laboratories accredited by a nationally recognized accrediting oodysignatories to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement {MRA) to the International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) Standard 17025, the following conditions shall be satisfied:

A technical evaluation shall be performed by UUSA Engineering for the specific M&TE being calibrated to identify any additional technical requirements that need to be included in the purchase order (e.g.

tolerances, accuracies, ranges, specific industry standards to be used).

_* _Minimum critical characteristics to include in the purchase order shall include: use of ISO 17025 accredited quality program, technical requirements identified in the technical evaluation, as-found calibration data when calibrated items are found to be out-of - tolerance, and identification of the laboratory equipment and standards used.

The purchase order shall also prohibit the use of a sub-supplier for commercial calibration and testing services.

Use of the ILAC accreditation process shall not be used for nondestructive examination {NOE) for nondestructive testing (NOT)

The accrediting body shall be a NRG recognized agency, such as, the National Voluntary Laboratory /\\ccreditation Program (NVLAP), the American Association for Laboratory Accreditation (A2LA) or./\\CLASS Accreditation Services U:1,CU\\SS). These agencies are signatories to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MR/\\ labs.

The scope of the accreditation covers the contracted calibration and/or testing service.

LSDC-21-011 In lieu of performing an audit or commercial grade survey of the calibration or testing service, a documented review of the supplier's accreditation shall be performed by UUSA QA to ensure the accreditation was performed by an NRG recognized agency tolLAC MRA signatory.

.I\\NSI/ISO/IEC 17025 andFor calibrations, the published scope of accreditation covers the needed measurement parameters, ranges and uncertainties. For testing services. the published scope of accreditation for the test laboratory covers the needed testing services, including test methodology and tolerances/uncertainty. In addition, the laboratory has achieved accreditation based on an on-site accreditation assessment by the selected Accrediting Body (AB) within the past 48 months.

APPROVED SUPPLIER LIST The UUSA Quality Assurance and Employee Concerns (QA) Manager is responsible for the development and maintenance of the UUSA ASL. The ASL contains those suppliers with acceptable QA Programs that have been evaluated and accepted by the UUSA QA in accordance with approved procedures. The UUSA QA organization shall perform and document an annual evaluation of each supplier. Satisfactory results will allow the supplier to Quality Assurance Program Description Revision 43~

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SECTION 16 Corrective Action Responsible management shall t-determine the cause and document corrective actions and actions completed in a timely manner. This shall include remedial actions and, if appropriate, actions to prevent recurrence.

Significant conditions adverse to quality are defined as:

A deficiency that would seriously impact a QL-1 (inclusive) item, activity or service from meeting or performing its intended function or output of assuring public health and safety; A QL-2 (inclusive) repetitive condition or deficiency that, if left uncorrected, would have a serious negative impact on QL-1 activities, services, or items.

A deficiency in QL-1 (inclusive) design that has been approved for fabrication or construction where the design deviates extensively from design criteria and bases; A deficiency in the fabrication or construction of, or significant damage to, QL-1 (inclusive) structures, systems or components that require extensive evaluation, re-design or repair in order to establish the adequacy of the structure, system or component to perform its

  • intended function of assuring public health and safety; A deviation from QL-1 (inclusive) performance specifications that shall require extensive evaluation, re-design, or repair to establish the adequacy of the structure, system or component to perform its intended function; A significant error in a QL-1 (inclusive) computer program used to support activities affecting quality after it has been released for use; A deficiency, repetitive in nature, related to a QL-1 or QL-2 (inclusive),

activity, service or item subject to the UUSA QAPD; and A condition that, if left uncorrected, has the potential to have a serious negative impact on QL-1 or QL-2 (inclusive) activities, services or items subject to the UUSA QAPD controls.

If a supplier or subtier supplier discovers a defect or noncompliance which the supplier evaluates as a substantial safety hazard, then the supplier shall be required to report the item under 10 CFR Part 21ij Reporting of Defects and Noncompliance, and notify UUSA in writing.

If the supplier or subtier supplier is unable to determine if the defect/non compliance is a substantial safety hazard then the supplier or subtier supplier is required to report the item to UUSA for determination of reportability. In accordance with the CAP, significant conditions adverse to quality shall be evaluated for a stop work condition to determine if stopping work is warranted. If a stop work condition is identified, management shall issue stop work in accordance with the applicable procedure. Upon completion of action(s) to return the related significant condition adverse to quality to compliance, management shall take appropriate action to lift and close (in part or total) the stop work order.

Quality Assurance Program Description Revision 43b~

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