Text

Enclosure 5 - Proposed Changes for LA-3605-0003, Quality Assurance Program Description for the American Centrifuge Plant
	ML20304A438
Person / Time
Site:	07007004
Issue date:	10/14/2020
From:	; American Centrifuge Operating, Centrus Energy Corp
To:	; Office of Nuclear Material Safety and Safeguards
References
	ACO 20-0036, EPID L-2020-LLA-0085
	Download: ML20304A438 (41)
	v • d • e

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Enclosure 5 of ACO 20-0036

Proposed Changes for LA.:.3605-00()3, Quality Assurance Program Description Jo~ the American Centrifuge Plant Infonn'ation Contained Wlthin Does Not Contain Export Controlled Information Reviewing Official #1014 Date. 10/14/2020

NR-3605-0003 Quality Assurance Program Description for the American Centrifuge Plant in Piketon, Ohio Docket No. 70-7004 October 2020 Docket No. 70-7003 Information Contained Within Does Not Contain Export Controlled Information Reviewing Official: # 10 14 Date: 10/14/2020

Quality Assurance Program Description for the American Centrifuge Plant Proposed Change 2020 Blank Page

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Quality Assurance Program Deycription for the American Centrifuge Plant **Proposed Change 2020 NR-3605-0003 QUALITY ASSURANCE PROGRAM DESCRJPTION FOR THE AMERICAN CENTRIFUGE -PLANT in* J>iketon, Ohio Docket No. 70-7004 Docket No. 70-7003 Proposed Change

Quality Assurance Program Description for the American Centrifuge Plant Proposed Change 2020 Blank.Page

Quality Assurance Program Description for the American Centrifuge Plant Proposed Change 2020 UPDATED LIST OF EFFECTIVE PAGES Revision 0 - 10 CFR 1045 review completed by G. Peed on 07/28/04; Export Controlled Information review completed by R. Coriell on 07/30/04.

Revision I - IO CFR I 045 review completed by L. Sparks on 03/04/05 and the Export Controlled Information review completed by R. Coriell on 03/ 10/05.

Revision 2 - 10 CFR 1045 review completed by J. Weidner on 11 /04/05 and the Export Controlled Information review completed by DA Hupp 11 /04/05.

Revision 3 - IO CFR I 045 review completed by J. Weidner on 02/ 17/06 and the Export Controlled Information review completed by DA Hupp 02/ 17/06.

Revision 4 - IO CFR I 045 and the Export Controlled Information review completed by G Peed 0 1/24/08.

Revision 5 - 10 CFR 1045 and the Export Controlled Information review completed by G. Peed 07/ 18/08.

Revision 6 - IO CFR I 045 and the Export Controlled Information review completed by M. Basham 9/29/08.

Revision 7 - 10 CFR 1045 and the Export Controlled Information review completed by R. S. Lykowski 1/ 14/09.

Revision 8 - 10 CFR 1045 and the Export Controlled Information review completed by R. S. Lykowski 1/27/09.

Revision 9 - IO CFR I 045 and the Export Controlled Information review completed by R. S. Lykowski 6/2/09.

Revision 10 - 10 CFR 1045 and the Export Controlled Information review completed by R. S. Lykowski 8/31 /09.

Revision 11 - IO CFR I 045 and the Export Controlled Information review completed by R. S. Lykowski I 0/ 15/09.

Revision 12 - 10 CFR 1045 and the Export Controlled Information review completed by R. S. Lykowski 4/20/ 10.

Revision 13 - 10 CFR 1045 and the Export Controlled Information review completed by R. S. Lykowski 7/23/ 10.

Revision 14 - IO CFR I 045 and the Export Controlled Information review completed by R. S. Lykowski 8/ 17/ 10.

Revision 15 - IO CFR I 045 and the Export Controlled Information review completed by R. S. Lykowski 11 /3/ 10.

Revision 16 - 10 CFR 1045 and the Export Controlled Information review completed by R. S. Lykowski 8/27/ 12.

Revision 17 - Reviewed and determined to be UNCLASSIFIED . Derivative Classifier R.S. Lykowski. Sensitive information reviews completed and approved for public release by R.S. Lykowski on 2/7/13 .

Revision 18 - Reviewed and determined to be UNCLASSIFIED. Derivative Classifier R.S. Lykowski. Sensitive information reviews completed and approved for public release by R.S . Lykowski on 7/28/15.

Revision 19 - Reviewed and determined to be UNCLASSIFIED. Derivative Classifier #4769. Sensitive information reviews completed and approved for public release by# I 014 on 6/ 17/ 16.

Revision 20 - Reviewed and determined to be UNCLASSIFIED. Derivative Classifier #4769. Sensitive information reviews completed and approved for public release by #IO I 4 on 08/26/16.

Revision 21 - Reviewed and determined to be UNCLASSIFIED . Derivative Classifier #4769. Sensitive information reviews completed and approved for public release by# IO 14 on 12/09/16.

Revision 22 - Reviewed and determined to be UNCLASSIFIED. Derivative Classifier #4769. Sensitive information reviews completed and approved for public release by #IO 14 on 03/09/ 17.

Proposed Change - Classification review completed by Derivative Classifier #4769 on April 16, 2020 and the Controlled Unclassified Information ~g.,, EC[) review completed by #1014 on A riL!§, 2020.

ro osed Chan e - Classification review com leted b Derivative Classifier #4769 on October 14 2020 and the Controlled Unclassifie EC! rcvicwcom lctcdb #l014onOctoberl4 2020.

ULOEP-1

Qzudity As~ance Program Description for the American C,entrifage Plant Proposed Change 2020 Pae:e Number Revision Number Page Number Revision Number*

Cover Page Proposed Change 16

Proposed Change .

Inside Cover Page Proposed Change 17 Proposed Change ULOEP-1 Proposed Change 18 , Proposed Change ULOEP-2* Proposed Chang~ 19 Proposed Change 1 Proposed Change 20 ~p~sed Ghange 11 _Proposed Change. 21. Proposed Change ill Propo~ Change

22 Proposed Change

iv Proposed Change . 23 Proposed Change 1 Proposed Change 24

Propc:,sed Change 2 .Proposed Change 25 Proposed Change 3 Proppsed Change 26 .Proposed Change 4 Proposed Change 27 Proposed Qiange 5 Proposed Change 28- Proposed Change

,6 Proposed Change 7 Proposed Chang~

8 Proposed Change 9 Proposed Change 10 Proposed Change 11 Pr_oposed Change 12 Proposed Change 13 Proposed Change 14 Proposed Change 15 Proposed Change

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Quality Assurance Program Description for the American Centrifuge Plant Proposed Change 2020 ACRONYMS.

ACP American Centrifuge Plant ANSI A.merieen National Stande:'rds Institute ASL Approved Suppliers List AsME* *~erican Society .of !v1echanical Engin~ers CFR Code ofFederal Regulations .

EDMS Electronic

. Document

. Management System IR.OPS .Items Relied on for ~afety ISTP Integrated Systems and Test Plans Lead Cascade American Centrifuge Lead Cascade Facility M&TE *Measuring and Test Equipment NRC .U.S. Nuclear Regulatory Commission QA Quality Assurance QAPD Quality Assurance Program Description

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QL .Quality Level uranium hexafluoride.

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Quality-Assw-ance Program Description for the American Centrifuge Plant Proposed Change 2020 Blank.Page 11

Quality Assurance Program Description for the American Centrifuge Plant Proposed Change 2020 TABLE OF CONTENfS 1.0 IN'TRQDUCTION.......................... ;.................. - ......................................... ~ ........................ 1 2.0 QUALITY ASSURANCE PROGRAM .................. ~ ........ ~ .... ~ ........... ~ ............................... ~ I.

3.0 DES~GN CONTROL ............*....*............*... ;..........*....*.........*........ ~ ......... ~ ........................7-1-f 4.0 PROCUREME.NT DOCUME.NT CONTROL .........*..... i-************~****************************~******2B

5.0 INSTRUCTIONS, PROCEDURES, AND ORAWINGS ........*..................................... 1!!4

.6.0 DOCU'MENT CONTROL **********************~**********************-*******************-******~************~********1!!4 7.0 CONTROL OF PUR~ED ITEMS AND SERVICES ......*.................................. ;.. l!S 8.0 IDENTIFICATION AND CONTROL OF ~MS ........ ~ ..........................................~ ..17U 9.0 CONTROL OF PROCESSES ***********~*************~******!***********************************************;*****1~ . I-10.0 INSPECTION....*.........................................*.................. ~ ........*.*.............*........................ lBaa I il.O TEST ~ONTROL ......... ~~ ................................................................ ~ .........*...... :............... lm 12.0 CONTROL OF MEASlJ.RING ~ TEST ~QUIPME.NT ........................... ~............. 2Q4 . I 13.o HANDLING, STORAG-E, AND SHIPPIN"G ............................................. ;.................... 21s

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14.0 ~SPECTION, TEST, AND OPERATING STATUS.~............. ~ ................................... .2i6 15.0 CONTROL OF NONCONFORMING ITEMS ............................................................ .226

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16.0 coRRECTIVE ACTION **.*******************~*****************************.;***************~**********************11******2F 17.0 QU~ITY ASSURANCE RECORDS ..........................*...................*.......................... ~

18.0 AUDITS

. ') :**********!~***************************~-'***************~*****************~******* ***************************-************.2.~ r I 19.0 PROVISIONS FOR CHANGES ........................ ~ ......~ .*.............. ;....*..........*........... ~ ..........27.a.o.

20.0 REFERENCES

......*.******111*****************************~**********************************************

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Quality .AsS1Uance Prowam Description for the American Centrifuge Plant Proposed Change 2020 FIGURES Figure 1.1-1 American Centrifuge Organizational Chart*... ~ ............... _. ......................... .28Y iv

Quality Assuran~ Program Description for the imerican Centrifuge Plant *P,:oposed Change 2020,

1.0 INTRODUCTION

The Quality Assurance Program Description (QAPD) d.escribed herein applies to the d~sign, procurement,, refurbishment/construction, manufacturing, testing, start-up, operation, inspection, maintenance, m:odificatipn, and future decommissioning of the American Centrifuge Lead Cascade Facility (Lead Cascade) and the American Centrifuge Plant (ACP) and meets 10 Code ofFederal R(!gulatiqns (C~) 70.~ (a)(l). * -

Jn _addition, this QAPD applies to* Regulatory Oyersight Agi:eement (ROA) related aefrlities .involving .the Gas Centrifuge Bnriehmen-t Plant (GCEP) leased or. subleased faeilities, The Lead Cascade .and ACP are located in Piketon, Ohio. The ,QAPD is applied using a graded approach as described in Section 2.0 *of this qAJ>D.

1.1 Organization

- - ,The Licensee mainu;rins overall responsibility for design, procurement,

refurbishment/construction, manufacturing, testing, ~-up, operation, maintenance, and future d~mmissioning of the Lead Cascade and the.ACP.

Figure l.1-l of.this plan shows the Ameri~.Centrifuge organization. The orp;aoivrtion is managed by Licensee staff and operated by a combii;iatiori of Licensee personnel; contractor, supplier-provided augmented staff, and consultants where appropriate.

1.2_ Responsibilities The*Senior Vice President, Field Operations reports 4> the President and Chief Executive

, Officer, and has overall responsibility for the safe operation and the deployment of American '

Centrifuge'Project(s), including facility design;, process equipment procurement; machine design,

, testing, and QlllO.ufacturing; enrichment plant refurbishment/construction; testing of facilities; a.Q.d tum-over to operations. The Senior Vice President provides strategic leadership and direction for 'the enrichment *operations, organiz,ation, including the functi,ons 'of operations; maintenance; project support; ep.gineering; system(s) testing; transpo~on; procurement; materials handling and storage; .industrial; radiological, and* nuclear safety; conduct. of openµions; * ~d future decommissiop.ing. * * *

-The Senior Vice President is respo~ible_ for th(? qualify assurance (QA) program and for determining'.the status, adequacy, and effectiveness of the QAPD. The Senior Vice President has designated the Director, QA the re,sponsibility for ensuring that the -project achieves its quality targets and 111:eets its regulatory driven quality commitments. This director is responsible *.

for QA for the operations, including future decommissioning as applicabie, at the Piketon, Oluo and, Oak _R,idge, Tennessee facilities; for vendors ap.d° suppliers; and for construction and manufacturing-activities; both for internal,. and external customers.

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Quality Assw-ance Program Description/or the American Centrifuge Plant Proposed Change 2020

The *Senior Vice* President .has designated the Director, Enghieering, Proc~meO:t, and Construction, during the refurbishment/construction of the American Centrifuge facilities, the responsibilities for .P~viding

technical' -adm,inistration and direction to the. Engineering, Procurement,. and Construction contractor(s); providing the primacy interface with the refurbishment/construction contractor(s) who are building out the* ,licensed facilities, arid managing the ~xecutj.on of the Balance 9f Plant work which the Licensee self performs .for *the deployment of the ACP. * *

Tue S~nior Vi~ President has designated*the General Manager the responsibility for the day-to-day' safe operation arid. associated support activities. for the *American Centrifuge Project(s). The Gen~ral Manager is responsible for the American Centrifuge Program and overall responsibility for implementation of the QAPD .. The. QAPD is .binding on all Licensee and con~r personnel involved with the American Centrifuge Project(s), as identified in contractual documents.

The Director, N:uclear Safety reports to the Senior Vice President and is matrixed directly to the .General Manager. This director is responsible for developing and µnp.lemeoting the nuclear safety program, µicluding technical oversight of nuclear safety, including nuclear criticality safety (NC8) and maintenan~ of the Integrated Safety Analysis (I8i*..), safety analysis training, review of procedures involving fissile material operations, and assessments of program implementation.

The Piketon Engineering Manager reports to the Director, Engineering and is the deleg*ated design _authority for f iketon operations and is matrixed directly to the General Manager. This manager is responsible for Piketon engineering activities in support of operations and future decommissioning, which includes maintaining the configuration management program; systems and design engineering; review of design. and modifications of items relied on for safety (IROFS); and supporting procurement *services. ~ manager.is also resp9nsible for deyelopmeot of the Integrated SY:stems and Test Plans (ISTPs) and.acceptance test coordination, in~luding test control; and approving.disposition of nonconforming* items when di*spositioned-as "repair or use-~-is. ".

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Die Operations Manager reports to the General Manager and is responsibl.e for fissile material operations, centrifuge operations, and spi:ft operations. This manager is responsible for directing ,activities of .the. Cascade '/ Recycle and Assemb.ly Operations Shift .Supervisors in operation of .the cascade, feed and withdrawal, and gas test, as well *as the Maintenance Work Ceo~ Supervisor for maintenance and -operations of the plant equipment, Balance of Plant

µtj.lities processes, and facilities. This includes centrifuge assembly, drying, transportation, and installation in the cascade~ safe operation of the uranium hexafhioride (UF6) processes in accordance with approved procedures; . proper receipt, storage, handling, and

_oosite transportation of UF6; execution *of the IST;Ps, initial start-up~ and operation of the centrifuge~

maehines, eql!ipmeot, and support systems. Other activities include select repair of centrifuge§_

maehines; maintenance; classified equipment *control; accountable property inventory, segregation; and disP,Ositio~; contractor sqpport; integrated pianning and schedtiling; ,~taker

,#'.iqes; mat¢al.s management support; and future decommissionin~ and disposal, activitie*s, 2 .

Quality Assw-~ce Program Description for the American Ce~ifuge Plant Proposed Change 2020 I.

ensuring all-activities are. perfo~ed in acrdance with approved programs, processes, arid procedures. *

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The Integrated Systems T~t/Start-up Manager reports to the Opei:ations Manager and is responsible for assisting in* the development and execution of the JSTPs 'which d~onstnite the proper operation of completeq. systems to,. ens~ that the systems* meet their intended* d~ign functions. This* manager is also responsible for the *aeceptance of turnover from Engineering, Procurement, and Constpiction 01; from tl.J.!nover from contractors/vendors to the Licensee; initial acceptan~ testing; and initial start-up of equipment and suppor(sy$m18: .

Maintenance Work Center Supervisor reports .to. the Operations Manager. The Maintenance. Work Center Supervisor is responsiJ:,le' for directing activities of the* Balance of .

PlantQP Operations ~htl;t Supervisors and of .the Maintenance Shift Supervisors in the I:

performance of preventive, predictiye, and correctj_ve maintenance and to provide support

.services on facilities and equipment, vrith the fflfoeption of eentrifuge machines, within ~proved I:

.programs, processes, and-procedures and personnel training limitations.* These. activities may include 'maintenance of electrical equipment; electronic and pneumatic mstrumentation and controls; .computers and programmable ~ntrollers; and mechanical maintenance, such as valve,

pump, *anq mechanical equipment repair a:nd replacement.

The Production Support Manager reports to the General Manager and is responsible for fire safety*; emergency management; security; radiation protection, which includes chemical ,

process safety, health- physics, industrial hygiene, and environmental/waste .management; and training and proced~, which .indudes records management/document control.

The Training and Procedures Manager reports to the Production Support Manager and is

.responsible for development and* implementation of* programs for indoctrination and* training_

identified in Section 2.0 of this QAPD. Also, this manager is responsible for the program for develop:tp.ent, review, approval, and issuance of procedures and the records management and document control program. .

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. The Business Services *Manager reports tq the General Manager-and is respqnsible for

. procurement; packaging, transportation, and materials management; finance; and information technolo*gy in support of the ~erican Centrifuge Pfoject(s). *

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The Procurement. Manager reports to .the Director, Procurement and Contracts and. is responsible for providing support services to the-Business Services M~er. for procurement and providing* P!OCurement matezjal control services (including supplier qualification: coordination, purchasing, contracting). This manager is also responsible for supply strategy *and developm~t of qualified long-lead_-tim~ and complex-system su~li_~. * *

. The Regulatory Manager reports to the General Manager and is responsible for.regulatory oversight functions and commitment management. -The Regulatory Manager, as delegated by the Senior Vice ~sident and General Manager, m~tains the day-tCK!ay interface with U.$.

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Quality Assurance Program Description for the American Centrifuge Plant Proposed Change 2020

. Nuclear Regulatory* C~mt;nission (NRC) representatives on matters of ~gulatory* *compliance.

lbi~ manager has responsibility for maintaining the *plant change process and ensuring the* plant change reporting requireD:1ents are met *-Tue Regajatory Manager is also responsible for implementing the Coi:rective Action Program; ensuring incident' investigations are performed and providing management with data to assure that corrective actions and commitments *are properly addressed an,d managed.to facilitate compliance with the implementing policies and procedures.

Tue Regulatory Mapager is 1 also responsibl(? for *the Nuclear Materials Control and A~un~ility (m4C&A). program.

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' I Tue Piketon QA Mi:mager reports to and recdves technical direction for QA matters from the Director, Quality Assurance and is mattjxed din:ctly to the General Manager. The Piketon QA . Manager is _responsible for .independent oversight. of Ameri~ Centrifuge Project(s)activities covered by this. QAPD: This includes maintenance and programmatic administration of the QAPD, poijcies, and, procedures -and for* assessing its effective implementation. lbis includes.the responsibility and authority for:

Formulating the,program d~bed in the Quality Assurance Program Description for the Ameri~ Centrifuge Plant; .

*Review and aj)proval of QAPD implementing procedures;

Review and approval of contractor and.supplier QA programs;

Monitoring the implementation* of the QAPD and assessing the eff~tiveness of the QAPD through audits and assessments;

Investigating any aspect of the QAPD to. identify problems with execution and to verify that corrective action is taken: in a timely manner;

Stopping unsatisfactory work or controlling further processing when warranted for 1 safety considerations; . . . ,, . .

Attending status meetings, interacting directly with line management, .and staying abreast of day-to-day activities to ensure adequate oversight; and Providing quality control activities for purchased and in-house manufactured items.

The organizational philosophy is based on the following principles:

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Quality is achieved by those *responsible for performing work. . This includes identifying, correcting, or recommending solutions for quality problems.

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Quality verifications and controls are performed by persons who are independent of the work performance activities, but who ma)'.' .report to the: managem~t. of the same 4

Quality Assurance Program Description for the American Centrifuge Plant Proposed'change 2020 organization. Persons responsi~le for assurance *,and v~rificatio~ of quality have sufficient organizational freedom to id~tjfy probl~, ,*initjate solutions, verify solutions and control further processing when necessary.

Quaµty -re~ated activities may be delegated to others, but management retains responsibility for the.overall effectiveness of the QAPD.

_Suppliers and contractors are required to have approved QA. programs consistent with this QA program;~ applicable to the*scqpe of work as specified in Section 4.0 of this QAPD. .

2.0 QUJ_\LITY ASSURANCE PROG~

QA elements of this section are applied to the design, refurbishment/construction, manuf~g, testing, start-up, operation, procurement, inspection, maintenanc,e, modification, and future d~commissioning of items relied on for safety (IROFSj, *arid activities affecting those IROFS, to ensure they will be available and reliable to perforni their safety :function when neeqed. The QAP_D is applied to IROFS in a graded approach to an extent commensurate with their importance to safety. Quality Levels (QL)° are established in accordance with their as

. importance to safety follov.:s:

Level

Criteria

QL-1 A single IROFS that prevents or mitigirtes a high consequence event.

QL-2 a

. Two or more IROFS that prevent or mitigate high 'consequence event; or one or more.IR.OPS .that prevents or mitigates an intermediate consequence event QL-3 Any item other than QL-1 and QL-2:

The requirements of.the QAPD are applied in total to QL-1 IROFS. The.process for.*

selecting modifications to QAPD-requirepients for QL-2 IROFS is described below. QL-3 items

. scope of this QAPD are outside the \

and are' controlled in accordance ..with standard *commercial practices. The application of the QA.PD is documented, planned, implemented, and maintained to provide reasonabl~ assurance that, together with other management m ~ s , IROFS will be available and ~ be relied on, when needed. * .

Procedures provide for a graded approach raking into consideration:

QL (risk significance);

Applicable ~gulations, industry codes, and_standards; 5

Quality .Assurance Program Description for the American Centrifuge Plant Proposed Change 2020

,ComJ?lexity or uniqueness of an item*or activity an.d the environment in which it has to function; . . . * .

Quality history of the item in service;

pe~e. to whic~ functional

comp~ance. can .be demonstrated or assessed by test, mspec:tion, or mamtenance methods, , .

Anti~ipated lif~ .span; Degreb of standardization; Impo:r:tance of data generated; Reproducibility of results; and Consequence of failure.

By. appropriately balancing considerations of importance and process ~papility, an appropriate level of quality is achieved commensurate with the activity's llilportance to safety. .

The results of the application of .the graded approach to quality are incorporated into design requirement :documents, specifications, p~ures, mstructions,- *drawings, inspection plans, test plans, procurement documents, *and other document$ that establish the requirements for items or activities.

, Compliance with QAPD requirements and associatecY' procedures is. mandatory.

Questions on QAPD requirements are referred for resolution ~o the Piketon QA Manager, who is the final authority on QAPD requirements. *'

The terms used. in the QAPD are* as defined in 10 CFR 70.4, Definitions and the American Society of: Mechanical Engineers .(ASME). standard NOA-I Quality As;urance Requirements for Nuclear Facility AjJ_plications, 2008 edition with the NOA-la-2009 addendaNQA. *1 19942008 vlith 2009 Addenda (NQA. 1 2008/090.), Part I, Introduction, ,

*Section 400, Terms and DefiriitionsSeetion.4. The term "design output .as used in this QAPD means "drawings, specifications, and other documents used to* define technical requirements of I IROFS." '. . .

Indoctrination, and training or' personnel performing o~ managing ~tivities affecting quality will meet the requirements of NOA-1-2008, Part I, Requirement 2, Quality A.i&W'<<nee Pregram, Pert ' 1 of A.8ME NQA 1 1994, Supplement .2S 4 Section 200, Suppkmenlfll'Y Requireme1:lfs for Per80_nnel lndoctrfnation and Training and Sectiofl: 500 Records.. .

Quality Control pfersonnel performing .inspection *and testing, as well as QA audit personnel, -will meet the requirements of NOA-1-20.08Part 1 of A~ME NQA 1 1994, Part I, Supplement. 28 !Requirement. 2, Section 3002, Sttppkmenta,,y Requirements for the 6

Quality Assw-ance Program Description for the American Centrifuge Plant Proposed Change 2'020 Qualifieotien <:>f Inspeetien cmd TestQuaH/ication Requirements Perselfinel_;and Section 400 Records (!.(Qualification. * * *

Personnel performing nondestructive examination will meet the requirements of SNT-TC- IA, The Americarz Society for No,ulestructive Testing .Recommended Practice, June 1980

~tion or later.

QA audit personnel will meet the requirements of NOA. 1 2008:ASME }>tQA 1 1994,.

Pru1 1, . Supplement 28 3Requirement 2. Qual-ity AS9ltl'-tfflee _Pregrflm. Seetions 303, .

. . &tppkmemary Requirements fa,' the Quelifie<<tien *of Quality Asiu,,ffl'lee .,-0,,eg,am Aud#

PersennelLetldAuditer. 304. Attdite,s B:B:d 305. Teer.niell Speeimists. * .

Each manager is responsible for the applicable indoctrination, training, and qualification of their personnel. .

. Managem~nt .of those .organizations implemen~ the QAPD, or. portions thereof, regularly assesses the adequacy of that .part of the program for which they* are responsible and will as~ its effective implementation.

Responsible sonior managers regularly ~ss the adequacy_ and eff~tive implementation of the QA elements through methods such as review meetings, audit reports, and corrective action reports.

3.0 DESIGN CO~OL Approved procedures-provide for performing the design*process.in a planned, controlled and. documented manner. The desigri control process includes the Integrated Safety Analysis arid

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Management Measures.

Design inputs, such as design bases~ performance requirements, regulatory requirements,

codes and standards, are* iden~ed .and* documented as design *requirements (e.g., primary requirements, functional- requirements, -and system requirements) ... Design requirement documents are reviewed and approved on a timely basis and to the level of detail necessary to . I*

permit the design activity to }?e carried out correctly and to provide a consistent basis for making

design decisions, accomplishing design verification measures, ~d evaluating design changes.

Changes, including the reason for the changes and, w~ether of' not prior NRC approval is required to make the changes, are identified, approved, documented; ~d ~ntrolled. .

Design pro~s activities are planned on a :timely basis *and to the level of detail necessary

. to* permit the d~sign process t9 be carried out correctly; to permit vetj.fication that the design inputs are correctly translated into (design documents; and to support interfacing design, procurement, manufacturing, and operation. Appropriate quality standards are identified aild documented. Changes from specified quality standards, including the reasons for the chang~s and whether or not prior NRC approval is required to ~ e the changes~ are identifie<'.l, approv~

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Quality Assurance Program Description for the American Centrifuge Plant Proposed Change 2020 documented, and controlled. Design methods, materials, parts, equipment, and processes that are essential to the function of the IROFS are selected and reviewed for suitability of application.

Assemblies, subassemblies and parts are clearly identified. Commercial grade items that have been modified or which need to meet special verification requirements are uniquely identified.

Final design output documents, including changes thereto, are relatable to the design input by documentation in sufficient detail to permit design verification.

Design ttl::HflHl::S-COntrol related to IROFS that consist of computer programs will be are developed, validated, and managed in accordance with NOA-1-2008 and NOA-la-2009ASME NQA 1 1994 , Basie-Part -1, equirement 3, Design Control, Section 800, Requirement 11 ----afld NQA 1 1994 Test Control and Part II, Subpart 2.7, Quality Assurance Requirements for Computer Software for Nuclear -P-kmt-Facility Applications.

Design analyses documents (e.g., calculations) contain sufficient detail as to the purpose, method, assumptions, design input, references, and units such that a person technically qualified in the subject can understand the analyses and verify the adequacy of the results without recourse to the originator. Design analysis, performed with computer systems, will list the software and version; hardware; inputs and outputs; and evidence of computer program verification/validation or alternate verification of the results. Design analysis documents are identifiable by subject, originator, reviewer, and date or by other identification such that the documents are retrievable.

Design verification is performed and documented, in accordance with approved procedures, by competent individuals or groups other than those who performed the original design. The extent and method of the design verification is a function of the importance to safety, the complexity of the design, the degree of standardization, the state of the art, past performance, and similarity with previous proven designs. Where changes to previously verified designs are made, design verification is performed for the changes, including an evaluation of the effects of the changes on the overall design and on any design analysis on which the design is based. Methods of design verification include any one or a combination of the following (as defined in NOA-1-2008, Part I, Requirement 3, Section 501 MethodsSupplement 3S I ofASME NQA 1 1994): -design reviews, alternate calculations, or the performance of qualification tests.

Verification by testing is performed when deemed necessary and demonstrates adequacy of performance under conditions that simulate the most adverse design requirementsconditions.

Verification of computer programs includes appropriate testing and validation. Design verification is performed in a timely mar.ner and is completed prior to relying upon the IROFS, or computer program to perform its function.

Verifiers are knowledgeable in the areas to be verified. The verifier may be a supervisor, provided the supervisor was not directly responsible for the design (i.e., did not specify a singular design approach or rule out certain design consideration and did not establish the design inputs used in the design) or provided the supervisor is the only individual in the organization competent to perform the verification. However, verification is more than a cursory supervisory 8

Quality Assurance Program Description for the American Centrifuge Plant Proposed Change 2020 I

.. reVIew. A supervisor with direct responsi~ility for th~ desi&n 'may yerify QL-2 ite~ .and serVIces.

Changes to final designs, field* changes, modifications, and nonconforming items

~spositioned "use-as-is" or "repair" are* justifi~ documented, and subj~t: to the design con~l m ~ s commensurate with the original design. Changes are reviewed and approved py the person or group with assigned design authority. Changes to designs that have been approved or

- .certifi~ by *the NR.c* (e.g., 10.CFR.Part 71 package design) ate subject* to the necessary

~~tional controls: * * * * * * **

Intema) and external design interfac:es are identified and controll~ and design efforts are . I

~ordiriated am.orig participating organiz.ations. Desigri information transmitted across interfaces is reviewed, approved, documented, and controlled. . *

. Final. design documentation and records trurt provide evidence that the design and design verification processes were performed in accordance with. this section are collected, stored, and maintained. ' .

. 4.0 PROCUREMENT DOCUMENT CONTROL Procurement documents include those requirements necessary to assure that the items .and services to be provided will be of the desired quality. These include the following, as appropriate: ..

111 Scope of Work. *

( ' . ' '

Basic Tech.meal Requirements - These include drawings, specifications, codes and industrial .standards with applicable revision data; test and inspection requirem~nts;*

~ial proc_esses; and special requirements

such as for designing, fabricating, cleaning,.idep.tification marking, erecting, packaging, handlirig; shipping;and storage:

QA*Requirenients-Th~se includ~ the requirements.for suppliers. of QL--1 items*and services and QL-2 services to have an acceptable QA program consistent with the*

applicable portions of .this QAPD (the requirement for the suppli~ to .have a

'documented QA 'program may be waived for .QL-1 commercial grade items);

provisions.for access to 1the supplier's facilities and.records for* source inspection and audit; and requirements for reporting. The extent of the program required will .depend

upon the, type and use of the item or servi~ being procured. .

. ~

Requirements* for the control '. of nonconfonnances and changes - These include prqvisions. to control and report nonconfopnarice and* changes to .products being delivered. 1 Requirements on Subtjer Suppliers -. These include the specification o,f procurement requirements on subtier suppli~:

9

Quality Assuranc~ Program Description for the American Centrifuge Plant Proposed Change 2020

Documentatio:p. Requirements. - These include requirements identifying documepts to

be submitted for information, review or approval*; instructions on record retention, turnover and disposition; and tl;te requirements for delineating the technical and.quality data required for ordering recommended spare and replacement parts and assemblies.

Procurement docmnents a:p.d chap.ges thereto are reviewed to ensure th¢y include the appropriate requirements as listed above. . The reyiew and documented . concurrence ~

performed by independent personnel having an ooderstanding 'of the requirements and intent of the procurement* document.

Changes to procurement documents, including changes made q.uring bid review, contract

.negotiatipns or post award, are subject to the same control as the original document.

5.0 INSTRUCTIONS; PROCEDURES, AND ORAWINGS Activities alfecting the availability and/or reliability of IR0FS . are. prescribed* by and accomplished in accordance with documented procedures, instructions, and drawings of a type appropriate to the circumstances. These documents include or reference appropriate acceptance criteria *for determining that prescribed activities have been satisfactorily accomplished.

Standard *guidelines for the format, content, and review and approval processes are established.

I - .

The. QAPD establishes the policy requirements. approved by the Senior Vice President, Field Operations'. Procedures are the second tier of documents that implement the QAPD. Third tier instructions provide specific step-by-step directions when deemed necessary. Procedure and instruction preparation, review, and approval are the responsibility of the applicable manager.

The QA organization reviews QA implementing p~ce4ures for compliance and consistency with this QAPD. Q1\review of procedures is performed to' ensure that the provisions of this QAPD are effectively incorporated into QA implementing procedures. *

Adherence to policy, procedures, and instructions is mandatory. In the case of conflicf:,. I.

the higher tier document governs unless approved by appropriate management. In the case of an a

error involving procedure, the activity in question shall be .placed in a safe condition and the procedure s~l be corrected or changed pefore proceeding to ipiplement the procedure.

Activities that require skills normally possessed by qualified- perso~el do not require

. detailed step-by-step delineation in a procedure. They are performed in accordance with documents of. a type appropriate to . the. circ~ces such as plEl:Bfl:Hlg

sheets, . job deseriptio~o~k instructions, test instructions/pl~ external manuals, or other form.

6.0 DOCUMENT CONTROL

\-

Documents ~d changes to documents that prescribe or specify qualify requirements or activities affecting the availability and/or reliability. of IROFS are controlled tu a manner that

assures the use of correct documents. Such docun;ients, including changes thereto, are reviewed for *adequacy ~d approved for release l:iy authorized personnel.

( .

Quality Assurance Program Description for the American Centrifuge Plant Proposed Change 2020

. Procedures and* instructions assure that documents are p~ed; reviewed for adequacy, correctness, and completeness by a qualified individual; appr~>Ved .for release by authorized personnel; distributed to*the location where the activity is performed prior to coril.Ip_encfug work; and used in performing the activity. Obsolete or superseded documents are ren;ioved or appropriately identified. Procedures identify do(;'uments to be controlled; responsibility for preparing,

reviewing, approving,

and

issuing documents to * *be used; and require the es4tblishment of c~nt and updated disµibution lists.. Procedmes also*~uire *the* creation and maintenance of a controlled* document index to track and. control approved revision levels of those documents. . .

Changes to docmnents are reviewed and approved in the. same manner as the original

~ess other organivitions are specifically 'designated. Reviewing personnel have access to the pertiJient background information upon which to base their approval. Procedures provide for simplified approval of ~torial or inconsequential changes. Procedures describe :the type of minor changes that do not require review and approval in th~ same :rµanner as the original and who can authorize minor changes.

7.0 CONTROL OF PURCHASED ITEMS AND SERVICES 7.1 General The procurement o'r items and services is controlled to assure conforman~ 'Vi.th specified requirements. These controls provide for the following; as appropriate: -source evaluation and selection; evaluation of objective evidence of quality furnis4ed by the supplier;* source

. inspection; audit; arid examination of items or services upon delivery or completion.

The following interface and* responsibilities apply for purchasing actions discussed in Sections 4.0.and 7.0 of this QAPD. *

The Pik~ton QA Manager is responsible for providing the necessary QA functions to

support procurement. These QA functions include review of supplier quality documentation; evaluation of supplier's QA _tapability; ~pplier audits and e".'aluatimlS; *~d fqr' 1;hy development. and _maintenanGe of an approved sqppliers list.

The Piketon QA Manager provides support :functions (i.e., source verification or

_surveillance; "receipt ~ o n s ; installation inspections; an~ review qf procurem~nt docume~~ during receipt inspec~ons). * * *

The Piketon Engineering Manager is responsible for assisting

the Piketon *QA

. Manager by* performing evaluations of *.supplieris~ technical capabilities. This m~mager is responsible for deterpiining *specific meth9ds of acceptance to be applied to purchased items and reviewing tp.e* specµic method of acceptance to be applied to services, This manager or designee is also responsible for the approval of dispositions 11

Quality Assur~e f'rogram Description for the American Centrifuge Plant Proposed Change 2020

)8.Ild technical yvaluation of *supplier-generated nonconformances for items and services dispositioned as '.'repair or *~-as-is." .

Th~ Procurement Manager is responsibl~ for procurement planning, bid evaluation, and procurement of items and services on the Approved Suppliers List (ASL), when required.

)

\_

12

Quality Assurance Program Description for the American Centrifuge PlanJ Proposed Change 2020 7.2 .Procurement Pla~niIJg

-Procurement activities are planned and documented to ~ a systematic approach to the procurement process'. Procurement document control is descnbed.in Section 4.0 of this QAPD.

7.3 Supplier Evaluation and* Selection .

. Supplier. selection is .b8:Sed, in part, on a pre-award evaluation of capability to provide

1 items or .~rvices in acco~ce (.with the requirements* qf procure1:Ilen~ documents. The evaluation includes one or more*ofthe following:

' /

I An e:valuation of f4e potential, supplier's. history of providing an identical or* similar product that performs satisfactorpy in actual use.

The supplier's history will reflect current capability .. The potential supplier:s current* quality records are supported by d0cumented qualitative and_quantitative information that can be objectiyely evaluated.

Depending on the part or service involved, a* supplier QA program meeting the

. applicable requirements of accepted industry regulatio_ns or standards *such as, NQA-1, ISO 9000 series, American National Standards II,lstitute (ANSI) 2540-1, 10 CFR Part 50, Appendix B, or '10 CFR 830.120,, may be acceptable. When *actions _that demonstrate the implementation of the *QA program have* commenced, the potential supplier's facility (if approptjate), technical and quality capability is determined.by a direct evaluati~n of the supplier's personnel, and implementation* of ~e supplier's quality assurance program. Supplier audits are conducted in accordance with Section 18.2 of this QAPD.

QA reviews and approves the results of recognized industry shared ~pplier audits, (i.e., third party audits such as the. Nuclear Industry Assessment Committee, etc.). The review ensures that tpe requirements in Section 7 .1, first bullet, have been met. When using this method, ab. initial implementation audit will be performed in accordance with Section 1'8.2 of this QAJ>D. * \.

The supplier has. an applicable vali~ Certific~e of Accreditation issued by*, the National Voluntary _Laboratory Accreditation* Program of the National Institute of Standards ..and Technology. When using µiis method, an initi~ implementation audit will be performed in accordance with* Section 18.2 of this QAPD ..

The supplier* maintains a valid ASME Code certification for the item or* service being provided. When using thi~ metho.d, an iµitial iinp.lementation audit will be performed in accordance with Section '18.2 of this-QAPD. i 13 I,

Quality As$w'ance Program Description for the American Centrifuge Plant Proposed Change 2020 Suppliers ~th acceptable technical, quality and commercial qualifie;atjoiis are placed on the ASL maintained, by the QA organiz.ation. Retention on the list is based on 'performance.

Suppliers that are not pre-qualified may be used' with appropriate compensatory controls as agreed UMn by *the QA organiz.ation.

7.4 Bid Evaluation Bids.\~ evaluated and. unacceptable ,conditions are resolved prior to aw_ard of the contract. Depending on the type of procurement, bids are evaluated for technical considerations, quality assuranqe requirements, supplier personnel, supplier* production capability, past performance, . alternates, . and exceptions; as well as commercial, cost, and

schedule considerations, as applicable.* .

7.5 Supplier. Performance Evaluation Measures are established to interface with the ~pplier and to verify supplier's performance, as necessary. The purchaser's verification activities; however, do not relieve the supplier of th~ir responsibilities for verification of quality achievement The measures include:

Establis~ing an adequate understanding between the Licensee *and the supplier on 'the provisions and specifications of the procurement documents; Requirements for the. suppli~ to identify the methods and processes to be used by *the supplier in fo]filling the requirements of the procurement; Reviewing the supplier documents generated or processed during activities fn]fi))jng procurement requirements; Identifying arid processing necessary change information; Establishing methods for exchange of information *with the supplier; and Establishing th~ extent of source . surveillance and inspection activities for subtier suppliers.

Activities to verify conformance to requirements in procurement documents are recorded as specified in procedures .. Source surveillances, inspections, audits, receiving jnspections, Condition Notifications, Material* Condition Reports,

Contractor Deficiency Notices, dispositions, wajvers, conditional. rel~.s, ~ corrective actions a.re* all documented. These

. records are evaluated during_ performance evaluations to. ensure suppliers are. effectively implementing their QA programs.

14

Quality A.sSW'ance Program Description for the American Centrifuge Plant Proposed Change 2020 7.6 Control of Suppli~r Generatl:(I Documents Supplier-geneta,ted documents required for submittal

are reviewed for acceptability.

Measures ensure that submittal *.of these documents is accomplished as required by the I '

procurement dpcuments. Eyaluation depends ob the type of d0<;uments submitted. The three categories are,: engineering documents requiring technical approval (e.g., shop drawings and-test procedures); yerification documents (e.g., test reports and inspection reports); and information documents (e.g., external manuals and parts lists). .

7.7 Acceptance of Items and Services Acceptability verification activities *are based on quality level, complexity, and quantity of items or services.provided. * *

Acceptance. of ,items, including spare and replacement parts, includes .one or more of the following methods: *

Certificate :of Conformance When this m,ethod 1s utilized during receipt inspection, the following minimum criteria are met:.

Tue certificate idet1tifies the purchased maurial or equipment ~r purchase order number.

The certificate identifies the specific procurement requirements met. .

. The certificate identifies any procurement requirements that were not met .and app~ved waiver.

The certificate is authenticated by a person responsible for this QA function.

The pr~edures, used for the, preparation, *review, and approval of the certificate, * .. I are described in the supplier's quality assurance program or the purchase order-;-

. The validity of the supplier's certificates and effectiveness of certification system is' verified, and the interval of v~rification is based on the supplier's ~ quality

. performance.

So~rce Verification - When *this method is utilized; it is performed at int~als consistent with the quality level and.complexity 'of the item or service. This method provides plans to perform ~ o n s , e~amioations, _or tests at predetermined points.

Source inspection niay be performed at lower tier* suppliers when necessary. Results

, _may be utilized at receiving inspection.

Receiving Inspection - When this method is utilized, purchased items are inspected

.to. verify conformance to procurement d~cuments.' This metho~ verifies ~y objective 15.

Quality Assurance Program Description for the American Centrifuge Plant Proposed Change 2020 *

. evidence such features as proper configuration; iden~cation; dimensional, physical,.

or other characteristics; freedom of damage from shipping; cleanliness, and review of supplier documentation when procµrement documents require the documentation to be

' furnished.

P~st-Installation Testing - When this method is. uti1ize4 post-installation* test requirements and acceptance eriteria documentation. are established in conjunction with tjie supplier~ ifne~Sffll:I'Y- .

Documented evidence of acceptability must be (?Omplete prior to placing an item in service.- Controls are established for conditional release, such as for po_st-installatioh testing. .

Acceptance of ~ervices is based on one or more of the following methods:

Technical verifi<?B,tion of data produced;

Surveillance 8!1d/or ~udit of the activity; and

Review of 9bjective evidence for conformance to procurement document requirements.

Acceptance of services includes review of contractor deliverables (including documentation and l1!COrds), determination of acceptability for use, completion. of acceptance testing, completion of start-up testing, turnover, _etc. .

7.8 Control of Supplier Nonconformances Supplier nonconformances are processed in accordance with Section 15.0 of this QAPD.

Supplier nonconformances consist of one or m~re of the following:

*Yiolation of technical or *material requirement;

Violation of requirement ~f purchaser-approved supplier 4ocument;

Nonconformance that* cannot be corrected by continuation of the manufacturing process or by rework;. and

Items that do not conform to the. original requirements even though the item can be restored to a condition such that .the caJxl9ility of the item to function is ~paired.

16

Quality Assurance Program Description for the American Centrifuge Plant Proposed Change 2020 Supplier nonconformance may be identified yith,er by the Licensee or *by the supplier.

For supplier identified nonconformance, the Licensee expects a supplier recommended c;lisposition and technical justification. Nonconforming items are nor released for use until the nonconforming condition is reviewed and accepted by Responsible Disposition Authority and the implementation of the disposition .is verified, except under conditional release provisions.

Records of supplier nonconformance are maintained.'

Nonconforman~s associated with QL-1 items or services are evaluated for reportabi)ity

pursuant to 10 CPR Part 21, Reporting of Defects arid Norµ:ompliance, and CMP-3603-0001, Graded Approach to Configw-~on M~gement and Quality Assw-ance. * **

7.9 Commercial Grade Items and Services Commercial grade items and services are identified in proc-qrement doctiments----by manufaeturer's pubµshed produet descriptions, in accordance 'with Section 4.0 ofthis QAPP. A commercial grade item satisfies the foll~wing:

.Not subject to design or specification requirements that are unique to nuclear facilities; Used in applications other than. nuclear facilities; and

Is to be orde~ from the manufacturer/supplier on the basis of a specification set forth in the manufacturer's published product description (e.g.,.catalog).

The criteria and acceptance methods for. services and for identifying the critical 1

characteristics for aeeeptanee of commercial grade items are established. Critical characteristics for acceptance are identified in Engineering Specificati'ons and provide reasonable assurance that the item provided meets specified requirements. When selecting these characteristics, the impact of the activities associated with the item on the safety function of plant equjpment is considered.

Changes to commercial grad~ items specified in qesign documents are subject to design control measures fu accordance with Section 3.0 of this QAPD.

As a minimum for acceptance of qommercial grade items, receipt ip.spection is performed to provide reasonable assurance that 'damage was not sustained during shipment; that.the item received is the item ordered; that inspection and testing was performed by the supplier, as required by Engin.eering, to. ellS1:lfe confo~ance *with manufacturer's published requirements; apd to ensure that required .documentation is received and is ~ptable. Based on. the .

complexity of the item or its importance to safety, one or more of the following acceptance methods may be use_d:

Method 1

Special test or inspection; Method 2 . ,;, . Commercial grade survey of the supplier; 17

(luality Ass~ance Program Description/or the American Centrlfuge Plant Proposed Change 2020" Method 3 .' . Source verification; .

.Method 4

Acceptable supplier/item performance- record.

Method 2 and .4 must* be used in conjunction with another method. . Dedication ef eommereial gm.de items occurs after re'.eeipt vmen thazyeri:ficalion and acceptance of the item or service is aeeep~ in accordance with engineering speeifiea-tiondocumented requirements and applies tq QL-1 only. The tenn-dedication*defines the point in tiine whe11: the commercial grade

-item or service becomes subject to.IO CFR Part 21 reporting requirements. * * ,I 8.0 IDENTIFICATION AND'CONTROL OF ITEMS

, Contro~s

are established to assure that only correct and. accepted. items are used or installed. Identification is maintained on the items or in documents traceable to the items, or in*a

manner that assures identification is established and maintained as described in this section.

( .

Items are identified an.d controlled, as necessary, from initial receipt and fabrication of the items up* to ,and* including installatiqn and use_ to assure_ *that only correct an~ accepted iteIQ.S are used or ipstalled. Physical identification i.s ~ to the maximum extent possible. When physical identification is

either impractical or insufficient .to *control the item, physical separation, procedural controls, or other *means are ~mploy~. When markings are use4 measures ~ established to ensure that the markings are clear, legible, and d_o not have .a detrimental ~ffect on the function or service life of the item. Markings are transferred to each 1*

part of an identified item when subdividing and are not to be obliterated by surface treatments or coatings uniess other means of identification are provided.

Traceability of items to specific reco~ds is provided when specified by codes, standards, or specifications:. *

Where specified, items having a limited. operating life or shelf life are identified and controlled.to preclude use of items whose operating*life or*shelflife has:expired.

. Procedures provide for. item identification consistent* with the planned duration and conditions: of storage, S?c~ as:

Provisions for* maintenance or replacement* of markings *and identification records due

~ 'damage during handling or ~g; '* :. * * *

Protection of identifications on items subject to excessive deterioration due to environmental. exposure; and Provis~on for updating existing records: Docume:p.tation ~ provided to show that items released for :use are the items specified.'

18

Quality Assw-ance Program.Description for the American Centrifuge Plant Proposed Change 2020

,L 9.0 CONTROL OF PROCESSES

. Processes affecting quality of items* and services are controlled. Procedures, instructions, drawings,* checklists~ travelers, work orders, or other appropriate means control processes. These means assure that process parameters are.controlled and that specified environmental conditions are maintained. *

Special processes that cpntrol or verify quality (i.e.~ those used ip. welding, heat treating, and nondestructive e~amination) are *performed *by qualified personnel .using qualified procedures in accordance with speci:q.ed requirements, cqdes; or standards.. When the o,utcoo;ie*

of the process is highly_ dependent on persQnal skills, such inditj,duals are certified in accordance with specified requireJp.ents. When the outcome is highly d~pendent on control of process parameters, the process and equipment". are pre-qualified in ~rdance with specified reqajrements. ' Special process procedures* prescribe the necessary 'equipment, process parameters~ calibration, and acceptance criteria Records are maintained of currently qualified personnel, processes, and equipment for.

special processes. '

10.0 INSPECTION Planned ~tions are performed, as required, to* yerify ~nformance of items or activities to specified.requirements. Inspection requirements are specified in written procedures, or design requirement docllrhents, with provisions for documenting_ and evaluating the inspecti~n results. Quality Control inspection personnel are qualified in accordance with S6ction 2.0 of this*

QAPD.

Personnel other than. those who performed or directly supervised the work being inspected perf~nil inspection for acceptance.

Inspection planning provides for hold points to ensure that work does not bypass required' inspections.

The h~ld points are established* in work controllipg documents.* Work does not proceed beyond an inspection hold point without specific documented consent of-the designated inspection repre~ntative. * * * '

The planning of inspection (which 'includes during *operation) ~tivities, methods, and attributes is based on the . importance of the iteni or activity to be inspected; mandatory

. inspections required. by. oodes, standards, regulatory requirements and commitments; the complexity Qf the item* or activity; and the quality history of. the proci?ss. IIµ;pection planning incluqe*s characteristics to be inspected; responsibility; method; measuring and test equipment;-

acceptance criteria; and* referenced instructions and design documents.

19 .

Quality Acyurance Program Description for the American Centrifuge Plant Proposed Change 2020 When a sample is used to verify acceptability of a- group of items, the sampling procedure is documented and is based on standard statistical methods *with engineeripg approval.olea.rly identifies tho smiwling basi~ (typioelly b ~ on reoo~ stancit¥d/p~iees) .. .1 ..

If inspection of completed work .is impossible or disadvantageous, indirect verification by process monitoring is provided. Both inspection anp. process monitoring are provided, when necessary, to*ensure quality. -

Final inspections include record review of the* ~suits and resolution of nonconf~rmance identified *by pnor .inspections. Acceptance by final inspection verifies conformance of the item to spec~ed requirements.

Modifications, repairs, or replacements of items perform~ subsequent to final inspection require re-inspection or re-test, appropriate to the circumstances, to venfy acceptability.

Periodic inspections (e.g., in-service inspections) or surveillances of structures, systems, or components are planned and executed to assure* fue continue& performance of their requited fimctions. * * *

Inspection* records contain the following, as a minimum:

Item inspected; nate of ipspection;

.. ~pector; Type of observation and inspection-plan;.

Results or acceptability; and

Reference to info~ati~~ on A!!c;tion taken in .connection with nonconformance.

11.0 TEST CONTROL Planned* tests are performed as required to v'erify conformance *with specified

~uireme~ts, to demonstrate satisfactory performance, or to ~llect data* Tests include design verification iests, acceptance tests, pre-operational ~sts, post-maintenance tests, and operational tests:* Planning for tests may include I,J1811datory hold points, as required. **

Test _procedures or design requirement documents contain the following information as

.. appropriate to the test: . .

20

Quality Ass,;,.ance Program Description for the American Centrifuge Plant Proposed Change 2020

Test purpose or objectives, responsibilities, characteristics to be te$d, hold points and test methods to b:e employed;

References and related documents;

Provisions *.for e ~ g that prerequisites for a giveff test have been _met. These include, as applicab.le: *calibrated instrumentation, approptjate equipment, trained

.personnel, condjtion of test equipment and *the item to be tested, and provisions for data acquisition; *

- Adeq~ instrumentation 1s available and suitable environmental conditions . are maintained;

Provisions for documenting ~d evaluating the test results for conformance with-test reqµirements and ~ptancekriteria;-and . * -

Qualificati_ons for tes_t personnel.

In lieu of written test procedures or design requirement documents, appropriate sections of related documents (e.g., American Society for* Testing and Materials methods, external manuals, maintenance instructions, or approved drawings or travelers 'with acceptance criteria) may be used. Such documents must include.adequate instructions to ensure the required quality of work.

Test records :contain the following information:. item tested, *test date, tester or data recorder, type of observation, test' procedure or design requirement documents, results and acceptability, actions taken in connection with any deviations noted, and person evaluating the results.

Computer Program Testing 'applicable to IROFS is carried out in accordance with NOA-1-2008 and NOA-la-2009, Part I, Requirement 11 Test Control.ASMB NQA 1 199_4,'Basie ReguiremeHt 11, Test Cemrel and Supplement 118 2,

8-upplemenffHY. Requi,ements for Cemputcr .f'reg,-em Testfng.

12.0 CO~OL OF MEASURING AND TEST EQUIPMENT Measuring .and Test Equipment (M&TE) used in a<;tiyities ~ecting the availa~ility .*

' and/or ~liability of IROFS are controlled; calibrated, and. adjusted at specified interval~ to maintain equipment performance* within required limits. Procedures ensure that devices and standards us¢ for measuremen~ tests, and calibration activities are of the proper type, range, and accuracy. Calibration reports and certificate*s providcdoeument information for interpretation of

. i 21

Quality Assurance Program Description for the American Centrifuge Plant Proposed Change 2020 calibration results and verification of compliance to applicable stated requirements. Calibration control is not necessary for rulers, tape measures, levels, stop watchesj, and other such devices.

A list of devices is established to identify those items within the calibration control system. This identification listing includes, as a minimum, the due date of the next calibration and any use limitations (when it is calibrated for limited use).

M&TE is calibrated at specified intervals or prior to use against equipment having a known valid relationship to nationally recognized standards._ M&TE will be calibrated against standards that provide a minimum accuracy ratio of 4: 1. If no nationally recognized standard exists or if the minimum accuracy ratio cannot be provided, the basis for the specified calibration is documented and approved by engineering. M&TE and 8-standards are handled, stored, and calibrated in environments specified by recognized standards or manufacturer specifications, which will not adversely affect their accuracy or precision. M&TE is properly handled and stored to maintain accuracy.

When M&TE is found to be out of calibration, as-found data are recorded.,_ and an evaluation is made and documented as to the validity of previous inspection and test results and of the acceptability of items previously inspected or tested. Out-of-calibration devices are tagged or segregated and are not used until re-calibrated. When M&TE is consistently found to be out of calibration, it is repaired or replaced . Also, calibrations are performed when personnel performing measurements and tests deem the accuracy of the equipment suspect.

Records are maintained and equipment is suitably marked or otherwise identified to indicate its calibration status.

13.0 HANDLING, STORAGE, AND SHIPPING Material and equipment are handled, stored, and shipped in accordance with design and procurement requirements to protect against damage, deterioration, or loss.

Special coverings, equipment, and protective environments are specified and provided where necessary for the protection of particular items from damage or deterioration. When such special protective features are required, their existence is verified and monitored as necessary to ensure they continue to serve the intended function.

Special handling tools and equipment are provided where necessary to ensure items can be handled safely and without damage. Special handling tools and equipment are controlled and maintained in a manner such that they will be ready and fit to serve the intended function when needed. Such control includes periodic inspection and testing to verify that special handling tools and equipment has-have been properly maintained. Operators of special equipment are experienced or trained as required.

22

\

Quality Assurance Program Description for the American Centrifuge Plant Proposrd Change 2020 Attention is .given to marking and labeling i~ms dq.ring 1 packaging, shipment, and storage. Additional marking or labeling is provided* as necessary to* e~ure that items can be properly maintained and preserved.. This includes indic'ation of the presence . of special environments or the ne~ for special control.

. Special

I handling, preservation, storage, cleaning,

packaging, or* shipping instructions are established .arid used .when essential to maintain accep~ble quality.

14.0 INSPECTION:, TEST; AND pPERATING STATUS*

Procedures are established to ensure that the status of inspection and test activities. are either marked or labeled on the. item or in documents traceable to the item. This activity is required wh(?n it is necessary to ensure that'requiied inspections and tests' are performed, and to ensure items that have. not passed the required inspections and tests are not inadvertently installed, used, or operated. \. . .

Status indicators (i.e.. , physical. l~cation aIJ.d tags; markings; work controlling documents; stamps; inspectio~ records; or .other suitable means) *are *utiliz.ed. when required. *This includes indicating the operating status of systems and components (i.e.,;by tagging valves and switches) to prevent inadvertent _operation. Authority for the application and removal of tags;* markings, labels, an_d ~ps is specified.

15.0 CONTROL OF NONCONFORMING ITEMS Items and,related activities that do not conform to specified*requirements are* controlled to prevent inadvertent installation or use.

Nonconforming items are ,identified in a manner that does not adversely affect the end use of the item, by markings, tagging, and other appropriate methods.

I -

Noncpnforming itt;ms are segregataj, when practical, by placing them in a clearly identified and designated area until pr<?perly dispositioned. When segregation is impractical qr

impossible due tq physical conditions (e.g., ~ize, weight, or access -limitati_ons), other measures are. employed to preclude inadve$nt use* of the item.

Nonconforming* items are: reviewed* and dispositioned. Further processing, delivery, installation, or use of the nonconforming item is controlled pending an evaluation and approved dispqsition by the Responsible Disposition Authority personnel, and documented notification to

~ected organiz.ation,s is provid~ *

The responsibility and authority for the

evaluation and disposition of nonconforming items is . defined.. The -personnel perfonw.ng eval,uations to determin~ the 'dispositions haye demonstrated competence in the specific area they are evaluating, have an adequate 23

0<<i}ity Assurance Program Description for the American Centrifuge Plant Proposed Change 2020 understanding of the, requirements, and have access to pertinent background information*. The disposition of nonconforming items is identified. and documented. as. required to carry out the disposition. Technical justifi~tion for the acceptability* of nonconforming items dispositioned

repair" or use-as-is" is* documented and: subject to design* CQntrol measures ~ *described in Section 3:0 of this QAPD. The disposition process includes *~iisideration of the need for design documents to be "as-built to fa.¢ilitate op~rati01i.s,' maintenance, or modification. The as-built records, if the disposition determines sucli reco~ to be required, reflect the accept~ deviation.

Repaired items. are re-examined in accordance. with applicable procedures arid witli the original acceptance criteria unless the nonconforming item disposition has established alternate I

acceptance criteria Reworked items are re-examined in accordance with applicable procedmes

!lllil_with the original acceptance .criteria. * .. *

/.

Nonconformance documentation. identifies the nonconfo~ item; describes the nonconformance; contains the disposition and any re-inspection requirements; and contains the signature(s) approving the disposition. .

16.0 CORRECTIVE ACTION Conditions adverse to quality are identified and corrected promptly. In the case of a significant condition adverse to quality, the cause of the condition is determined, and corrective action is. taken to preclude recurrence. Significant conditions, their causes; and corrective actions are documente4 reported to appropriate levels of nianagemen~ and f9llow-up action is taken to verify implementation of corrective actions. Additional requirements associated 'Yith corrective actions are _found in Chapter 11, Section 11.6, of the License Applications.

17.0 QUALITY ASSURANCE RECORDS The QA.records system ensures that ~rds are specified, prepared, and maintained in a manner t9 provide protection and i-etnevability. Design specifications, procurement documents, test procedures, operational procedures, or other documents 'Specify the records to be generated, supplied, or maintain~ ..

Procedures ~eorda are oonsidered vaijd when they Bi'eestablished to ensure QA records are .complete, legible, ttaceable to item and activities, maini:ained, and retrievable. eomplete, I

identified, authen-tieated and legible. Documents' are considered valid* records only if stamped, initialed, or signed .and dated by authorized personnel or otherwise. authenticated. Electronic records will be authenticated with identification .found on the media" or with authentication information coritained within or linked to*the document itself. Lifetime*rRecords are entered into record storage after receipt or validation. Temporary storage in approved *eonta.ifters is pro:rlided until reeords Bi'e 0ftte~* into lifetime storage'.

24

/

Quality Assurance Program Descriptionfor the American Centrifuge Plant Proposed Change 2020

. bifetime-QA_records arc.defined classified jn accordance with.NOA-1-2008A8J\4E NQA 1 *. 1994, Part I, Requirement 17. Supplement 178 1, Section,401 Lifetime *Records~

Suppkmenltlry Reqt,tir-e1-1Jents far Quality A&ur<<nec Records. The applicable document that specifies the recorq indicates those to be forwarded fer-to the* Electronic Document Management.

sSystem (EDMS) oi: other location/system *approved for record* storagclifetime storage. In the case of specified records produced by suppliers, an agreefilent' for recor~ turnover is establj.shed.

. . } ' '

Lifetime records. are retained for the life of the-item to which they apply or as required by a regulatory agency. An indexing system ensures the reco:rd can be retrieved. . Storage is in a central_ location unless the applicable procedure specifies* otherwise. Records may be origirials, 1 copies, or eleytronic format . ** ..

. Nonpennanent. records are those required to show evidence that an activity was performed in_ accordance* with applicable requirements. Nonpermanent records are Bet-retained for.the lifu of a purtieular* item per the Retention Schedule and in accordance with the records management process-; Nonpermanent reeords are retained by the r~onsible organi ?ation until they 8!C no longer useful. .The retention periods for nonperm-anent reeords will be established in writmg by the roopoB:Sible orgamm-tion.

. Corrections to records are approved by the originating organization. The cqrrections include the date and the identification of the individual authorized to issue the correction.

~odianship. responsibility is aisigned for ~ e quality records storage.

Custodianship includes receipt and status control; storage; *preservation; and safekeeping-using

hard copy, electronic media ~erofilm, or EDMS~~eetronie doeuinent management system..

I Storage facilities pro~t . against .the ,risk of loss or 4eterioration of lifetime quality

.records. Hard copy or micro:fiJ.m storage facilities meet the requirements ofNOA-1-2008AS:MB NQA. *1 1994, Part I, Requirement 17,

8uppleB:1ent 178 1, Section. 4-A-600 'Storage, Supplementary Requirements far- Quality AsSUl'ancc Recor-de. For electronic storage, backups,. or duplicate files are generated. Lost or damaged records are replaced, unless deemed impractical with the _concurrence.of the QA oreanization. .

Singl~ copy records 8:fe checked out of sto~e only if they cannot be copied and then only for a limited period. Temporary protection in sµch cases is provided by prudent business practices (e.g., record of custody, office environment, and work-place security). I' 18.0 AUDJ,TS

. Planned and scheduled audits are performed by the QA organization to verify compliance With the aspects ofthe*QA program-and_ to determine its effectiveness.

18.1 Internal Audi~

I 25

Quality Assurance Program Description for the American Centrifuge Plant Proposed Change 2020

" 1 '.

Internal audits* *of organizational units performing quality program *activities* are perform¢ at a frequency commensurate ~th the* status and . importance of the activity:

Regularly

scheduled audits are supplemented by additional audits/asses~ents of specific subjects. The system of audits ~d assessments is designed to ensure comprehensive program oversight at least. once every three years. The three-year cycle provides for flexibility to maximize effectiveness of QA resources by targeting areas of weakness using supplemental assessments verses using resources auditing areas that are known to be functioning adequately.

This flexibility will result in more effective quality overii.ght and use of reso~s. The proper mix of audit and* assessment will provide an* ~ffective and comprehensive QA independent oversight program. Audits are conducted in accordance with a documented procedure. A plan is prepared for each audit to identify ~ audit scope, requirements, audit personnel, activities to be audited, applicable documents, organizations to be audited, schedtile .and written procedures or checklists.

The audit team contains one or more auditors, one being designated lead auditor who prepares, organizes, and directs* the audit; coordinates the preparation and issuance *of the audit report; and evaluates responses. Audit team members are independent of any direct responsibility for performance of the activities of which they will audit Auditors (including technical specialists) have experience commensurate with the scope, complexity, or special nature of the audit. The lead auditor is qualified in accordance with Section 2.0 of.this QAPD ..

Audits are performed in accordance -with checklists or equivalept. Organizations being audited provide access and *assistance to the audit team.. Objective evidence is examined to determine if the QAPD elements *are being implemented effectively. Conditions requiring prompt corrective action are reported immedi.ately to :r;nanagement of the audited organiz.ation.

The results of the au~t are discussed with management of the.audited organization,

The audit report includes the following information, as appropriate:

D~scripti~n. of the .au~t scope;

.Identification of the auditors; Identification of persons contacted during audit activities; Summary of audit results, including a statement on the effectiveness of the .QA program elements audited; and Description of each reported adverse: audit finding in sufficient detail to enable corrective action to be taken by the audited-organization.

M~ement of the audited orgaruz.ation or activity investigates adverse audit findings and. docutnents and schedules corrective action, including measures. to* prevent recurrence.

Adequacy of audit responses is evaluated by the QA organization and verification of corrective action is documented.

26

. Quality .MSW'ance Program Description for the American Centrifuge Plant Proposed Change 2020

Follow-up action is taken by the QA organization* to verify the implementation and effectiveness of the corrective action *and to determine if repetitive problems 1, require further corrective action in *accorcfunce with Section *16.0 of this QAPD. Am;lit records include audit

plans, audit reports, corrective action dpcumentation, and the record of completion- of corrective action. * .

18.2 External Audits External audits are performed~ to verify the accepta~ility of QL-1* Sllppliers. After the placement of the supplier., ASL, follow-up audits are performed at a frequency commensurate

with the status and importance of the activity, based on annual eval:uations of.the QL-1 suppliers~.

performance. ' '

Third party audits ~ be ~ to satisfy the supplier, audit requirement, after review and

. acceptance of the audit recorcis by QA. * * . *

. QL-2 suppliers need not be audited provided their performance continues to be.

acceptable.

The external audit team contains one or more auditors, one being designated lead auditor who prepares, organizes, and directs the audit; coordinates the preparation and issuance of the audit report; .and evaluates* responses*.* Auditors (including technical specialists) have experience commensurate with the scope, complexity, or special nature of the audit. The lead auditor is qualified in accordance with Section 2.0 of this Q~D.

External audits are performed U;1. ~rdance* with checklists or equival1:mt* Objective evidence is examined to determine if the QAPD elements are being implemented effectively.

Conditions requiring prompt corrective action are reported immediately to management of the audited organization. *The results of the audit are 'discussed with management of the audited organization..

The external audit_report includes the following info!ffiRtion, as appropriate:

. Description of the audit scope;*.

Identification of the auditors;

Identification of persons contacted during audit activities; Supun-ary of audit results, including a statement on the effectiveness of the QA program elements audited; and

Description of .each reported adverse audit finding in sufficient detail to enable corrective action to be *taken by the audited orgattjz.ation.

27

Qudity Akuance Progr~ Description for the American C~ge Plant Proposed Change 2020 Follow-up action is taken by the QA organization to verify *the implementation and effectiveness _of the* corrective action and to detennine if repetitive problems require further

corrective action in accordance with Section 16.0 o:f this QAPD. Audit records include audit

plans, audit reports, corrective action documentation, and the record of completion of corrective action. * '

28 f'

Quality .Assurance Progr(IlTI Description for the American Centrifuge Plant Proposed Change 2020 i9.0 PROVISIONS FOR CHANGES QAPD changes are controlled by 10 CFR 70.72, Plant Facility Changes and'_Change I.

Process. QAPD changes may be initiated by events such as reorganizations, revised activities, as a result of lessons learned, changes -to applicable regulations,. process .\

changes, or other reasons. QAPD cjianges are governed 9y approv~ procedures. -* *

Changes not requiring NRC approval prior to implementation will be submitted to the NRC annually, in accordance \1/2th 10 CFR 70.72. . .

20.0 REFERENCES

1. 10 CFR 70.4, Definitions

2. 10 CFR 70.72, Facility Changes and Change Process

3. American Society of Mechanical Engineers (ASME) standard NQA-1, -l994,-Quality.

Assurance Requirements for Nuclear Facility Applications, 2008 edition with the NOA-la-2009 addenda * *

4. SNT-TC-lA, The American Societyfor Nondestructive Testing Recommended Practice, June

1980 Edition

5. 10 CFR 830, EJfefflf)tion Deeision, June 30, 2009

6. EKhibit M, Rcgul-atery (}yefwight Agreement (Between United* Stares DOE lnd United Stcttes Enrier.ment Cerporooon fer the Gtm Ce,nh'ifage Enrichment Plflnt LetiSed l'remises), Rev. {)

'.7-;~10 CFR Part 21, Reporting ofDefects and Noncompliance

&-6_,__CMP-3603-0001, Graded Approqch to Configurati~n Management and Quality Assurance

. 9. EPRI NP 5652, (J-uidelinefer the Utiliwtion ofCommereim Grclde Items in Nueleflr '&ifety Rel-atedAppllemions (NCIG 07) 29

Quality Assurance Program Description for the American Centrifuge Plant Proposed Change 2020

.SeRlorVlca Pl'ftb:llmt, Reid Opei tiotd l:>lractM, Enlineerlnl, PreteUramant,. .nt1 _______________..___________ _

Dlr9ctor, Qudty . Oractor,NucfNr Dlractor, Enpnui1ns Auunince Constnictlon G.-l M n,pr / Safety { Duian Authority)

HAl.BJ Program

~---Pikett,_Anu

__ " nm_Qu_ce_dty

_ __.~ -- -- -- * -- * - ~ u*j* _*-------: : ---

I

,M-.-

l I

I I

NlidNr Crfticlty Samy Plic.ton EnglnHrlng

( ~ Dvilcl'l Authority}

I I I

lnchJm'lals.flity ---------------J I

I I

I

*-------*----- ------ ___ .., ~~

I RqulatDry

. Busmus*

OperllllianJ Production ***

Servka* . SuppDl't ** Conll'1.I rat! on

r-----.----J I Cuade / Rl!IC'(de ----------~'.. ** Man ... mant

~ --f lntqmad Nudur Matarlllls Control and I I

Prccwem llnt ) S¥mm1T'at/

. 9trt-up 11nd ~ Q l y OparMfof\11 Shfl't

.___Supammrs

_ _ _ _* __. II 1

I Ara Safety/ Em&fle!ICV Mana,*rn*nt __.

l l

'~

Acco unmbillty I I

1* Packapn1, ,----------, I

~-*

Radltlan ProtKtion I Mllintan11nce Work : Mwwgar / Suparvflor *Hulth ~yslcs and p-.1.spomtfon,

'- --- -and Matmllils Canter Supilrvllclr :

L __ _ ~IH','llanll Mllmlp!ITM!nt M.lntenuce Security Pi11nnt1r Envlronmantlll / Wuta

, Mimap-m:

BOPOperat101111

Training nd Shift :!h1pw\fbors Procedures M inten. nai Shift Supavlsors Recorcl.-

_M n.pment I

Documant Control

Figure 1.1-1 American Centrifuge Organizational Chart 30.

v t e Letter Sequence Request
EPID:L-2020-LLA-0085, Centrus Energy Corp. Final Environmental Assessment for High Assay Low-Enriched Uranium (HALEU) LAR (Approved, Closed)
Initiation Request, Request, Request, Request, Request, Request, Request, Request, Request Acceptance Supplement, Supplement Administration Questions Answers 14 October 2020 Results Approval Other: ML21138A828, ML21148A147, ML21148A261, ML21148A291, ML21153A407
MONTHYEAR2021-04-27 [Table View]

ML20304A438

Text

20.0 REFERENCES

1.0 INTRODUCTION

20.0 REFERENCES

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