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NUSCALE POWER- LO-0515-14330 Enclosure 2: "NuScale Topical Report: Quality Assurance Program Description for the NuScale Power Plant," (QAPD) Revision 2 NuScale Power, LLC 1100 NE Circle Blvd., Suite 200 Corvallis, Oregon 97330 Office 541.360-0500 Fax 541.207.3928 www.nuscalepower.com
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Page 1: NUSCALE POWER- LO-0515-14330 · POWER-LO-0515-14330 Enclosure 2: "NuScale Topical Report: Quality Assurance Program Description for the NuScale Power Plant," (QAPD) Revision 2 NuScale

NUSCALEPOWER-

LO-0515-14330

Enclosure 2:

"NuScale Topical Report: Quality Assurance Program Description for the NuScale Power Plant," (QAPD)Revision 2

NuScale Power, LLC1100 NE Circle Blvd., Suite 200 Corvallis, Oregon 97330 Office 541.360-0500 Fax 541.207.3928

www.nuscalepower.com

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NuScale Topical Report: Quality Assurance Program Description for the NuScale Power ReactorNP-TR-1010-859-NP

Rev. 2

Licensing Topical Report

NuScale Topical Report: Quality Assurance ProgramDescription for the NuScale Power Plant

May, 2015

Revision 2

Docket: PROJ0769

Nonproprietary

NuScale Power, LLC1100 NE Circle Blvd., Suite 200

Corvallis, Oregon 97330

www.nuscalepower.com

© Copyright 2015 by NuScale Power, LLC

© Copyright 2015 by NuScale Power, LLC

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PROPRIETARY INFORMATION NOTICE

THIS DOCUMENT DOES NOT CONTAIN PROPRIETARY INFORMATION.

COPYRIGHT NOTICE

This document bears a NuScale Power, LLC, copyright notice. No right to disclose, use, or copy any ofthe information in this document, other than by the U.S. Nuclear Regulatory Commission (NRC), isauthorized without the express, written permission of NuScale Power, LLC.

The NRC is permitted to make the number of copies of the information contained in these reports neededfor its internal use in connection with generic and plant-specific reviews and approvals, as well as theissuance, denial, amendment, transfer, renewal, modification, suspension, revocation, or violation of alicense, permit, order, or regulation subject to the requirements of 10 CFR 2.390 regarding restrictions onpublic disclosure to the extent such information has been identified as proprietary by NuScale Power,LLC, copyright protection notwithstanding. Regarding nonproprietary versions of these reports, the NRCis permitted to make the number of additional copies necessary to provide copies for public viewing inappropriate docket files in public document rooms in Washington, DC, and elsewhere as may be requiredby NRC regulations. Copies made by the NRC must include this copyright notice in all instances and theproprietary notice if the original was identified as proprietary.

© Copyrght 2015 by NuScale Power, LLCii

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Department of Energy Acknowledgement and Disclaimer

This material is based upon work supported by the Department of Energy under Award NumberDE-NE0000633.

This report was prepared as an account of work sponsored by an agency of the United StatesGovernment. Neither the United States Government nor any agency thereof, nor any of theiremployees, makes any warranty, express or implied, or assumes any legal liability orresponsibility for the accuracy, completeness, or usefulness of any information, apparatus,product, or process disclosed, or represents that its use would not infringe privately ownedrights. Reference herein to any specific commercial product, process, or service by trade name,trademark, manufacturer, or otherwise does not necessarily constitute or imply its endorsement,recommendation, or favoring by the United States Government or any agency thereof. Theviews and opinions of authors expressed herein do not necessarily state or reflect those of theUnited States Government or any agency thereof.

© Copyrght 2015 by NuScale Power, LLCiii

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CONTENTS

1.0 Part I- Introduction ...................................................................................................... 3

1 .1 G e n e ra l .......................................................................................................................... 3

1.1.1 Scope/Applicability ......................................................................................................... 3

1 .2 A b b re v ia tio n s .................................................................................................................. 4

2.0 Part II- Quality Assurance Program Description Details .......................................... 6

2 .1 O rg a n iz a tio n ................................................................................................................... 6

2.1.1 Chief Executive Officer ................................................................................................... 6

2.1.2 Business Systems .......................................................................................................... 6

2 .1 .3 T e c h n o lo g y ..................................................................................................................... 6

2.1.4 Chief Operating Officer/Chief Nuclear Officer ................................................................. 7

2.1.5 Authority to Stop W ork .................................................................................................... 8

2.1.6 Quality Assurance Organizational Independence ........................................................... 9

2.1.7 NQA-1-2008 Comm itment .............................................................................................. 9

2.2 Quality Assurance Program ........................................................................................... 11

2.2.1 Responsibilities ............................................................................................................ 12

2.2.2 Delegation of W ork ....................................................................................................... 12

2.2.3 Periodic Review of the Quality Assurance Program ...................................................... 12

2.2.4 Issuance and Revision to Quality Assurance Program .................................................. 12

2.2.5 Personnel Training and Qualifications ........................................................................... 12

2.2.6 NQA-1-2008 Comm itment and Exceptions ................................................................... 13

2.3 Design Control ............................................................................................................... 13

2.3.1 Design Verification ........................................................................................................ 14

2.3.2 Design Records ............................................................................................................ 15

2.3.3 Com puter Application and Digital Equipment Software ................................................. 15

2.3.4 NQA-1-2008 and NQA-la-2009 addenda, Com mitment ............................................... 15

2.4 Procurement Document Control .................................................................................... 15

2.4.1 NQA-1-2008 Comm itment/Exceptions .......................................................................... 16

2.5 Instructions, Procedures, and Drawings ........................................................................ 16

2.5.1 Procedure Adherence ................................................................................................... 17

2.5.2 Procedure Content ....................................................................................................... 17

2.5.3 NQA-1-2008 Comm itment ............................................................................................ 17

2.6 Document Control ......................................................................................................... 17

@ Copyhght 2015 by NuScale Power, LLCiv

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2.6.1 Review and Approval of Documents ......................................................................... 18

2.6.2 Changes to Documents ........................................................................................... 18

2.6.3 NQA-1-2008 Comm itment ......................................................................................... 19

2.7 Control of Purchased Material, Equipment, and Services ......................................... 19

2.7.1 Acceptance of Item or Service ................................................................................. 19

2.7.2 NQA-1-2008 and NQA-la-2009, Comm itment/Exceptions ...................................... 20

2.8 Identification and Control of Materials, Parts, and Components ................................ 21

2.9 Control of Special Processes ..................................................................................... 21

2.9.1 NQA-1-2008 Comm itment ......................................................................................... 22

2 .1 0 In s p e ctio n ...................................................................................................................... 2 2

2.10.1 Inspection Program .................................................................................................. 22

2.10.2 Inspector Qualification ............................................................................................. 23

2.10.3 NQA-1-2008 Comm itment/Exceptions ....................................................................... 23

2 .11 T e st C o n tro l ................................................................................................................... 2 3

2.11.1 NQA-la-2009 addenda, Commitment for non-Computer Program Testing ............... 23

2.11.2 NQA-1-2008 and NQA-la-2009 addenda, Commitment for Computer ProgramT e stin g .......................................................................................................................... 2 4

2.12 Control of Measuring and Test Equipment ................................................................ 24

2.12.1 NQA-1-2008 Com mitment/Exceptions ....................................................................... 24

2.13 Handling, Storage, and Shipping ............................................................................. 24

2.13.1 Housekeeping .............................................................................................................. 25

2.13.2 NQA-1 Comm itment/Exceptions ................................................................................ 25

2.14 Inspection, Test, and Operating Status .................................................................... 25

2.14.1 NQA-1 Comm itment .................................................................................................. 26

2.15 Nonconform ing Materials, Parts, or Com ponents .................................................... 26

2.15.1 Interface with the Reporting Program ...................................................................... 26

2.15.2 NQA-1-2008 Commitment ......................................................................................... 26

2.16 Corrective Action ...................................................................................................... 26

2.16.1 Interface with the Reporting Program ...................................................................... 27

2.16.2 NQA-1-2008 Commitment ......................................................................................... 27

2.17 Quality Assurance Records ...................................................................................... 27

2.17.1 Record Retention ...................................................................................................... 27

2.17.2 Electronic Records .................................................................................................... 27

@ Copyright 2015 by NuScale Power, LLCV

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2.17.3 NQA-1-2008 Com mitment and Exceptions ................................................................ 28

2 .1 8 A u d its ............................................................................................................................ 2 8

2.18.1 Performance of Audits ............................................................................................. 28

2.18.2 Internal Audits ............................................................................................................... 29

2.18.3 NQA-1-2008 Comm itment ......................................................................................... 29

3.0 Part III-Nonsafety-Related Structures, Systems, and Components QualityControl ........................................................................................................................ 30

3.1 Nonsafety-Related Structures, Systems, and, Components-SignificantContributors to Plant Safety ....................................................................................... 30

3 .1 .1 O rg a n iz a tio n ................................................................................................................. 3 0

3.1.2 Quality Assurance Program ....................................................................................... 30

3.1.3 Design Control .............................................................................................................. 30

3.1.4 Procurement Document Control ............................................................................... 30

3.1.5 Instructions, Procedures, and Drawings .................................................................... 30

3.1.6 Document Control .................................................................................................... 31

3.1.7 Control of Purchased Items and Services ................................................................ 31

3.1.8 Identification and Control of Purchased Items ............................................................ 31

3.1.9 Control of Special Processes ..................................................................................... 31

3 .1 .1 0 In s p e ctio n ..................................................................................................................... 3 1

3.1.11 Test Control .......................................................................................................... 31

3.1.12 Control of Measuring and Test Equipment ................................................................ 31

3.1.13 Handling, Storage, and Shipping ............................................................................. 32

3.1.14 Inspection, Test, and Operating Status .................................................................... 32

3.1.15 Control of Nonconform ing Items ................................................................................ 32

3.1.16 Corrective Action ...................................................................................................... 32

3 .1 .1 7 R e c o rd s ........................................................................................................................ 3 2

3 .1 .1 8 A u d its ........................................................................................................................... 3 2

3.2 Nonsafety-Related Structure, System, and Components Credited for RegulatoryE v e n ts ........................................................................................................................... 3 3

4.0 Part IV- Regulatory Com m itm ents ...................................................................... 34

4.1 Nuclear Regulatory Commission Regulatory Guides and Quality AssuranceS ta n d a rd s ...................................................................................................................... 3 4

© Copyrght 2015 by NuScale Power, LLCvi

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Abstract

This topical report provides a description of the NuScale Power, LLC Quality AssuranceProgram (QAP) for the NuScale Power Reactor. For ease of reference, this topical report isreferred to as the Quality Assurance Program Description (QAPD). The QAPD has beenprepared in accordance with the requirements of Title 10, Part 50 of the Code of FederalRegulations (10 CFR 50), "Domestic Licensing of Production and Utilization Facilities," AppendixB, "Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants," andASME NQA-1-2008 and NQA-la-2009 addenda, "Quality Assurance Program Requirements forNuclear Facilities" as endorsed by Regulatory Guide 1.28, Revision 4, "Quality AssuranceProgram Criteria (Design and Construction)." This report was prepared consistent with theguidance in NUREG-0800, "Standard Review Plan for the Review of Safety Analysis Reports forNuclear Power Plants" and Nuclear Energy Institute (NEI) 11-04A Revision 0, "QualityAssurance Program Description (QAPD)" template.

The topical report is divided into four parts: 1.0 Introduction; 2.0 Quality Assurance ProgramDescription (QAPD) Details; 3.0 Nonsafety-Related Structures, Systems, and Components(SSC) Quality Control; and 4.0 Regulatory Commitments.

Consistent with common licensing practice, most of the application text is written in the presenttense, active voice. It should be understood, however, that statements regarding the processestypically address activities that may have not yet been performed and will not be performed untilit is reasonable and appropriate to do so.

© Copyright 2015 by NuScale Power, LLC

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Policy Statement

NuScale Power (NuScale) shall design nuclear plants in a manner that will assure thehealth and safety of the public and workers. These activities shall be performed incompliance with the requirements of the Code of Federal Regulations, the applicableNuclear Regulatory Commission (NRC) licensing requirements, and applicable laws andregulations of state and local governments.

The NuScale Quality Assurance Program (QAP) is described in this document, theQuality Assurance Program Description (QAPD) and the associated implementingdocuments, which include policies, plans, and procedures. Together, they provide forcontrol of NuScale activities that affect the quality of safety-related nuclear plantstructures, systems, and components (SSCs) and include all planned and systematicactivities necessary to provide adequate confidence that such SSCs will performsatisfactorily in service. The QAPD may also be applied to certain equipment andactivities that are not safety-related, but support safe plant operations, or where otherNRC guidance establishes program requirements.

The QAPD is the top-level policy document that establishes the manner in which qualityis to be achieved and presents NuScale's overall philosophy regarding achievement andassurance of quality. Implementing documents assign more detailed responsibilities andrequirements and define the organizational interfaces involved in conducting activitieswithin the scope of the QAP. Senior management establishes overall expectations forobtaining the desired end result. Compliance with the QAPD and its implementingdocuments is mandatory for NuScale Power personnel directly or indirectly associatedwith the implementation of the QAPD.

Signed

John Hopkins

Chief Executive Officer

NuScale Power, LLC

Date: May 14, 2015

© Copyright 2015 by NuScale Power, LLC

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1.0 Part I-Introduction

1.1 General

NuScale Power's (NuScale) Quality Assurance Program Description (QAPD) is the top-level policy document that establishes the quality assurance policy and assigns majorfunctional responsibilities for nuclear power reactor activities conducted by or forNuScale. The QAPD describes the methods and establishes quality assurance andadministrative control requirements that meet 10 CFR 50, Appendix B, 10 CFR 52, and10 CFR 21. The QAPD is based on the requirements and recommendations of ASMENQA-1-2008 and NQA-la-2009 addenda, "Quality Assurance Requirements for NuclearFacility Applications," Parts I and II, with specific reference to selected sections in Part IIIand IV, as specified in this document.

The Quality Assurance Program (QAP) described in this report consists of the QAPDand associated implementing documents, which include policies, plans, and procedures.Quality Assurance Program Description requirements are defined by Regulatory Guide1.28, Revision 4, which endorses NQA-1-2008 and NQA-la-2009 addenda, which inturn describes the required Quality Assurance (QA) elements. Procedures andinstructions that control activities will be developed prior to commencement of thoseactivities. Policies establish high-level responsibilities and authority for carrying outimportant administrative functions that are outside the scope of the QAPD.

Procedures establish practices for certain activities that are common to all NuScaleorganizations performing those activities so that the activity is controlled and carried outin a manner that meets QAPD requirements. Procedures specific to an organization orgroup establish detailed implementation requirements and methods and may be used toimplement policies or be unique to particular functions or work activities.

1.1.1 Scope/Applicability

The QAPD applies to the following activities affecting the quality and performance ofsafety-related structures, systems, and components (SSCs), in support of designcertification activities

* designing

* procuring

• fabricating

* cleaning

* inspecting

* receiving

* handling

* shipping

* storing

© Copyright 2015 by NuScale Power, LLC3

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" testing

" training

Safety-related SSCs, subject to the requirements of the QAPD, are identified in designdocuments. The technical aspects of these items are considered when determiningprogram applicability, including, as appropriate, the item's design safety function. TheQAPD may be applied to certain activities where regulations other than 10 CFR 50 and10 CFR 52 establish QA requirements for activities within their scope.

The policy of NuScale is to assure a high degree of availability and reliability of a nuclearplant(s) while ensuring the health and safety of its workers and the public. To this end,selected elements of the QAPD are also applied to certain equipment and activities thatare not safety-related, but support safe, economic, and reliable plant operations, orwhere other Nuclear Regulatory Commission (NRC) guidance establishes qualityassurance requirements. Implementing documents establish program elementapplicability.

The definitions provided in NQA-la-2009 addenda, Part I, Section 400 apply to selectterms as used in this document.

1.2 Abbreviations

Table 1-1. Abbreviations

Term i DefinitionA-WS anticipated transient without scramCEO__ chief executive officerCFR Code of Federal RegulationsCOO/CNO chief operating officer/chief nuclear officerDC design certificationFSAR final safety analysis reportILAC International Laboratory Accreditation CooperationM&TE Measuring and Test equipmentMRA Mutual Recognition ArrangementNRC Nuclear Regulatory CommissionNEI Nuclear Energy InstituteNIRMA Nuclear Information and Records Management AssociationNRC Nuclear Regulatory CommissionQA Quality AssuranceQAP Quality Assurance ProgramQAPD Quality Assurance Program DescriptionRG (NRC) Regulatory GuideSBO station blackoutSSCs structures, systems, and componentsTG technical guide

© Copyrght 2015 by NuScale Power, LLC4

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Table 1-2. Definitions

Term DefinitionApplied research Research intended to solve a specific problem or meet a practical

need.Basic research Research conducted to acquire new knowledge of a theoretical or

._experimental nature.Design certification (DC) The process of research and design activities that develop and

support an application to the NRC for certification of a standard designnuclear power reactor.

Design process Technical and management processes that commence withidentification of design input and that lead to and include the issuanceof design output documents.

Developmental research Activities associated with the application of proven theory andexperimental results and their extension to its end use, e.g., use in adesign environment.

NuScale Power Plant A modular, scalable nuclear power plant consisting of 50 MegawattsI electrical light water reactors developed and designed by NuScale

Power, LLC.Quality Assurance Program The QA Program (QAP) described in this report consists of the QAPD(QAP) and associated implementing documents, which include policies,

plans, and procedures.Quality Assurance Program The document that describes the policies, scope, organizations,Description (QAPD) objectives, processes, and methods that constitutes the NuScale QAP

relative to U.S. domestic licensing requirements for nuclear powerplants. The QAPD document is entitled "Quality Assurance TopicalReport" NP-TR-1010-859-NP, "Quality Assurance Program Descriptionfor the NuScale Power Reactor." The QAPD is the top level policydocument establishing the quality objectives and methods of NuScalePower, LLC.

Research and Development Activities that are conventional in nature to the advancement ofsupport activities knowledge and development of technology but allow the primary

purpose of the work to be accomplished in a credible manner (e.g.,calibration of measuring and test equipment).

Sub-tier implementing Procedures, instructions, drawings, forms, and other forms ofdocuments communicating prescribed methods, processes, sequences,

authorization/authentication, quantitative /qualitative acceptancecriteria, and required documentation necessary to assure and providedocumented evidence of the quality of NuScale end products andservices.

© Copyright 2015 by NuScale Power, LLC5

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2.0 Part II-Quality Assurance Program Description Details

2.1 Organization

This section describes the NuScale functional organizational structure, functionalresponsibilities, levels of authority, and interfaces for establishing, executing, andverifying QAPD implementation. The functional organizational structure includescorporate and support functions, including interface responsibilities for multipleorganizations that perform quality-related functions. Implementing documents assignmore specific responsibilities and duties, and they define the organizational interfacesinvolved in conducting activities and duties within the scope of the QAPD. Managementgives careful consideration to the timing, extent, and effects of organizational structurechanges.

The NuScale quality assurance function is responsible to size the quality assurance staffcommensurate with the duties and responsibilities assigned.

Design, engineering, and testing services are provided to NuScale by qualifiedcontractors in accordance with their QA programs or by contractors working under theNuScale QA program. These contractors are evaluated and approved prior to performingsafety-related work.

The following sections describe the reporting relationships, functional responsibilities,and authorities for organizations implementing and supporting the NuScale QAP. TheNuScale functional organization is shown in Figure 2-1.

2.1.1 Chief Executive Officer

The NuScale chief executive officer (CEO) is responsible for all aspects of design of theNuScale Power Plant. The CEO is also responsible for all technical and administrativesupport activities provided by NuScale and its contractors. The CEO directs the businesssystems function, the chief operating officer (COO)/chief nuclear officer (CNO), and thetechnology function in the fulfillment of their responsibilities. The CEO reports to theNuScale Board of Directors with respect to all company matters.

2.1.2 Business Systems

The business system function reports to the NuScale CEO and, in addition to normalfinancial functions customarily managed, is responsible for other company-wideadministrative functions, including the integration of company information technologycontrols and infrastructure, the development of company-wide system of policies andprocedures, and the document control and record management system.

2.1.3 Technology

The technology function reports to the NuScale CEO, and in addition to technologydevelopment and research collaboration, is also responsible for design certificationtesting and code development. Testing responsibilities include ensuring that testpersonnel are qualified and that test service providers develop facilities and testprograms capable of providing accurate data defining the operating characteristics of the

© Copyright 2015 by NuScale Power, LLC6

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NuScale design. Code development responsibilities include the development of thermalhydraulic software code and the qualification and modification of existing analyticalsoftware codes.

2.1.4 Chief Operating Officer/Chief Nuclear Officer

The NuScale chief operating officer/chief nuclear officer (COO/CNO) is responsible forall areas of engineering, safety analysis, corrective action program, human resourcesand project management consistent with regulatory requirements and proceduralguidance. The COO/CNO is responsible for ensuring that all function and projectmanagement functions understand the implementing procedures, that their direct reportsare adequately trained and qualified to those procedures prior to performing assignedtasks, and that those direct reports develop their respective work products consistentwith the requirements established by those procedures. The COO has the responsibilityto develop and deploy integrated project schedules with associated budget and projectmanagement controls. The COO/CNO reports to the CEO. The COO/CNO is alsoresponsible for leading the development of an effective company-wide SafetyCulture/Safety Conscious Work Environment (SCWE) Program.

2.1.4.1 Operations and Engineering

The operations and engineering function reports to the COO/CNO and is responsible forensuring the NuScale Power Reactor is designed for safe, simple, and reliableoperation. Operations and engineering is responsible to issue and control drawings,specifications, calculations, and other documents that define the NuScale design, acceptsuch documents from others for incorporation into the NuScale design, and delegatesuch authority to others. In this capacity, Engineering provides the fully integrated suiteof engineering, design, safety analysis products and processes necessary to define thedesign (and to support associated procuring, fabricating, testing, and training) of theNuScale Power Plant to the requisite technical, safety, performance, and qualitystandards.

2.1.4.2 Program Management

The program management function reports to the COO/CNO and is responsible toeffectively and efficiently execute projects across the company in a consistent manner.This is achieved through the development of project plans; scope; and budgets andschedules by working in coordination with internal services, support organizations andcontract resources; problem anticipation, identification, and resolution; and defining anddelivering reports on project performance.

2.1.4.3 Regulatory Affairs

The regulatory affairs function reports to the COO/CNO and is responsible for licensingactivities associated with the NuScale Power Plant and standard plant design anddevelopment. Regulatory Affairs develops, implements, and monitors the NuScaleLicensing Plan and provides licensing recommendations to senior management. Thisfunction is the single point of contact with regulatory agencies for effectivecommunications and is responsible for 1) administration of the 10 CFR 21 evaluation

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and reporting program and 2) ensuring that licensing-related requirements and

commitments are addressed and controlled in an effective manner.

2.1.4.4 Supply Chain

The supply chain function reports to the COO/CNO and is responsible for development,evaluation, and administration of the NuScale supply chain. Responsibilities includeinterfacing with engineering and quality assurance functions to ensure that suppliers ofsafety-related services are evaluated prior to award and all applicable technical andquality requirements are effectively communicated through procurement documents.

2.1.4.5 Human Resources

The human resources function reports to the COO/CNO and is responsible for allpersonnel decisions regarding recruitment and retention.

2.1.4.6 Quality Assurance

The quality assurance function is responsible for independently planning and performingactivities to verify the development and effective implementation of the NuScale QAPD,including, but not limited to, NuScale Power Plant engineering, document control,corrective action program, and procurement processes.

Quality assurance reports to the COO/CNO. Quality Assurance is responsible fordevelopment, implementation, and maintenance of the QAPD and is responsible forverifying that activities are in compliance with applicable regulatory, code, and industrystandard requirements. If Quality Assurance disagrees with actions taken by theNuScale organization and is unable to obtain resolution, Quality Assurance shall informthe COO and has the authority to directly bring the matter to the attention of the CEO forfinal disposition.

Quality Assurance is responsible for assuring compliance with regulatory requirementsand procedures through audits and technical reviews; for monitoring organizationprocesses to ensure conformance to commitments and licensing documentrequirements; and for ensuring that suppliers providing quality services, parts, andmaterials to NuScale are meeting the requirements of 10 CFR 50, Appendix B throughNuScale supplier evaluations, surveillances, and audits. Quality Assurance has sufficientindependence from other priorities to bring forward issues affecting safety and qualityand to make judgments regarding quality in all areas necessary regarding NuScaleactivities.

2.1.5 Authority to Stop Work

Quality assurance and inspection personnel have the authority, and the responsibility, tostop work in progress that is not being performed in accordance with approvedprocedures where safety or SSC integrity may be jeopardized. This extends to off-sitework performed by suppliers that furnish safety-related items and services to NuScale.

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2.1.6 Quality Assurance Organizational Independence

Independence shall be maintained between the organizations performing the checking(quality assurance and control) functions and the organizations performing the functions.This provision is not applicable to design review/verification.

2.1.7 NQA-1-2008 Commitment

In establishing its organizational structure, NuScale commits to compliance with NQA-1-2008, Requirement 1, Sections 100 through 300.

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Figure 2-1. NuScale organization

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2.2 Quality Assurance Program

NuScale has established the necessary measures and governing procedures toimplement the QAP as described in the QAPD. NuScale is committed to implementingthe QAP in all aspects of work that are important to the safety of the nuclear plant(s) asdescribed and to the extent delineated in the QAPD. The QAP shall include monitoringactivities against acceptance criteria in a manner sufficient to provide assurance that theactivities important to safety are performed satisfactorily. Further, NuScale ensuresthrough the systematic process described herein that its suppliers of safety-relatedequipment or services meet the applicable requirements of 10 CFR 50, Appendix B.Senior management is regularly apprised of the adequacy of implementation of the QAPthrough the audit functions described in Section 2.18 in this document.

The objective of the QAP is to assure that NuScale Power Plants are designed inaccordance with governing regulations and requirements. The program is based on therequirements of ASME NQA-1-2008 and NQA-la-2009 addenda, "Quality AssuranceRequirements for Nuclear Facility Applications," as further described in this document.The QAP applies to those quality-related activities that involve the functions of safety-related SSCs associated with the design, fabrication, and testing of the NuScale PowerPlant and to the managerial and administrative controls to be used to assure theNuScale Power Plant design complies with applicable regulatory requirements.Examples of safety-related activities include, but are not limited to, basic, applied, anddevelopmental research; determination of SSC safety class; design configurationmanagement; and document control. A list or system that identifies SSC and activities towhich this program applies is maintained at NuScale. Cost and scheduling challengesmust be addressed; however, they do not prevent proper implementation of the QAP.

As described in Section 3.0 of the QAPD, specific program controls are applied tononsafety-related SSCs, for which 10 CFR 50, Appendix B is not applicable, but that aresignificant contributors to plant safety. The specific program controls consistent withapplicable sections of the QAPD are applied to those items in a selected manner andtargeted at those characteristics or critical attributes that render the SSC a significantcontributor to plant safety.

Delegated responsibilities may be performed under a supplier's or principal contractor'sQAP, provided the supplier or principal contractor has been approved as a supplier inaccordance with the NuScale QAP. Periodic audits and assessments of supplier QAprograms are performed to assure compliance with the supplier's or principalcontractor's QAPD and implementing procedures. In addition, routine interfaces with thesupplier's personnel provide added assurance that quality expectations are met.

In general, the program requirements specified herein are detailed in implementingprocedures that are either NuScale implementing procedures or supplier implementingprocedures governed by a supplier quality assurance program.

A grace period of 90 days may be applied to provisions that are required to be performedon a periodic basis, unless otherwise noted. Annual evaluations and audits that must beperformed on a triennial basis are examples where the 90-day general period could beapplied. The grace period does not allow the "clock" for a particular activity to be reset

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forward. The "clock" for an activity is reset backwards by performing the activity early.

Audit schedules are based on the month in which the audit starts.

2.2.1 Responsibilities

Personnel who work directly or indirectly for NuScale are responsible for achievingacceptable quality in the work covered by the QAPD. This includes the activitiesdelineated in Section 1.1. NuScale personnel performing verification activities areresponsible for verifying the achievement of acceptable quality. Activities governed bythe QAPD are performed as directed by documented instructions, procedures, anddrawings that are of a detail appropriate to the activity's complexity and effect on safety.Instructions, procedures, and drawings specify quantitative or qualitative acceptancecriteria as applicable or appropriate to the activity, and verification is against thesecriteria. Provisions are established to designate or identify the proper documents to beused in an activity and to ascertain that such documents are being used. The NuScalequality assurance function is responsible to verify that processes and procedures complywith the QAPD and other applicable requirements, that such processes or proceduresare implemented, and that management appropriately ensures compliance.

2.2.2 Delegation of Work

NuScale retains and exercises the responsibility for the scope and implementation of aneffective QAP. Positions identified in Section 2.1 in this document may delegate all orpart of the activities of planning, establishing, and implementing the program for whichthey are responsible to others, but they retain the responsibility for the program'seffectiveness. Decisions affecting safety are made at the level appropriate for its natureand effect and with any necessary technical advice or review.

2.2.3 Periodic Review of the Quality Assurance Program

Management of those organizations implementing the QA program, or portions thereof,assess the adequacy of that part of the program for which they are responsible to assureits effective implementation at least once each year or at least once during the life of theactivity, whichever is shorter.

2.2.4 Issuance and Revision to Quality Assurance Program

Administrative control of the QAPD is in accordance with 10 CFR 50.55(f). Changes tothe QAPD are evaluated by the NuScale quality assurance organization to ensure thatsuch changes do not degrade previously approved quality assurance controls specifiedin the QAPD. This document shall be revised, as appropriate, to incorporate additionalQA commitments that may be established over time. New revisions to the document willbe reviewed, at a minimum, by the NuScale quality assurance organization andapproved by the COO/CNO.

2.2.5 Personnel Training and Qualifications

Personnel assigned to implement elements of the QAPD shall be capable of performingtheir assigned tasks. To this end, NuScale establishes and maintains formalindoctrination and training programs for personnel performing, verifying, or managing

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activities within the scope of the QAPD to assure that suitable proficiency is achievedand maintained. The indoctrination, training, and qualification programs arecommensurate with scope, complexity, and importance of the activities; and include oraddress the following, as appropriate:

" Education, experience, and proficiency of the personnel receiving training

" General criteria, technical objectives, requirements of applicable codes andstandards, regulatory commitments, company procedures, and quality assuranceprogram requirements

" On-the-job training, if direct hands-on applications or experience is needed toachieve and maintain proficiency

Sufficient managerial depth is provided to cover absences of incumbents. When requiredby code, regulation, or standard, specific qualification and selection of personnel isconducted in accordance with those requirements as established in the applicableNuScale procedures. Indoctrination includes administrative and technical objectives,requirements of the applicable codes and standards, and the QAPD elements to beemployed. Records of personnel training and qualification are maintained.

The minimum qualifications of the individual in charge of quality assurance are that he orshe holds an engineering or related science degree and a minimum of four years ofrelated experience, including two years of nuclear power plant experience, and one yearof supervisory or management experience, with one year of that experience performingquality verification activities. Special requirements shall include management andsupervisory skills and experience or training in leadership, interpersonal communication,management responsibilities, motivation of personnel, problem analysis and decisionmaking, and administrative policies and procedures. Individuals who do not possessthese formal education and minimum experience requirements are not eliminatedautomatically when other factors provide sufficient demonstration of their abilities. Theseother factors are evaluated on a case-by-case basis and approved and documented bysenior management.

The minimum qualifications of the individuals responsible for planning, implementing,and maintaining the programs of the QAPD are that each has a high school diploma, orequivalent, and has a minimum of one year of related experience. Individuals who do notpossess these formal education and minimum experience requirements should not beeliminated automatically when other factors provide sufficient demonstration of theirabilities. These other factors are evaluated on a case-by-case basis and approved anddocumented by senior management.

2.2.6 NQA-1-2008 Commitment and Exceptions

In establishing qualification and training programs, NuScale commits to compliance withNQA-1-2008, Requirement 2, Sections 100 through 500.

2.3 Design Control

NuScale has established and implements a process to control the design and designchanges of items that are subject to the provisions of the QAPD. The design process

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includes provisions to control design inputs, outputs, changes, interfaces, records, andorganizational interfaces within NuScale and with suppliers. These provisions assurethat design inputs (such as design bases and the performance, regulatory, quality, andquality verification requirements) are correctly translated into design outputs (such asanalyses, specifications, drawings, procedures, and instructions) so that the final designoutput can be related to the design input in sufficient detail to permit verification. Designchange processes and the division of responsibilities for design-related activities aredetailed in NuScale and supplier procedures. The design control program includesinterface controls necessary to control the development, verification, approval, release,status, distribution, and revision of design inputs and outputs. Design changes anddisposition of nonconforming items as "use as is" or "repair" are reviewed and approvedby the NuScale design organization or by other organizations so authorized by NuScale.

Design documents are reviewed by engineers knowledgeable in QA to ensure thedocuments contain the necessary QA requirements.

2.3.1 Design Verification

NuScale design processes provide for design verification to ensure that items, computerprograms, and activities subject to the provisions of the QAPD are suitable for theirintended application and consistent with their effect on safety. Design changes aresubjected to these controls, which include verification measures commensurate withthose applied to original plant design.

Design verifications are performed by competent individuals or groups other than thosewho performed the original design but who may be from the same organization. Theverifier shall not have taken part in the selection of design inputs, the selection of designconsiderations, or the selection of a singular design approach, as applicable. Thisverification may be performed by the originator's supervisor provided the supervisor didnot specify a singular design approach, rule out certain design considerations, and didnot establish the design inputs used in the design, or if the supervisor is the onlyindividual in the organization competent to perform the verification. If the verification isperformed by the originator's supervisor, the justification of the need is documented andapproved in advance by management.

The extent of the design verification required is a function of the importance to safety ofthe item under consideration, the complexity of the design, the degree ofstandardization, the state of the art, and the similarity with previously proven designs.This includes design inputs, design outputs, and design changes. Design verificationprocedures are established and implemented to assure that an appropriate verificationmethod is used, the appropriate design parameters to be verified are chosen, theacceptance criteria are identified, and the verification is satisfactorily accomplished anddocumented. Verification methods may include, but are not limited to, design reviews,alternative calculations, and qualification testing. Testing used to verify the acceptabilityof a specific design feature demonstrates acceptable performance under conditions thatsimulate the most adverse design conditions expected for the item's intended use.

NuScale normally completes design verification activities before the design outputs areused by other organizations for design work and before they are used to support otheractivities such as procurement or testing. Procedures are established that require

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identification and control of any portion of the design where verification has not beencompleted. When such timing cannot be achieved, the design verification is completedbefore relying on the item to perform its intended design or safety function.

2.3.2 Design Records

NuScale maintains records sufficient to provide evidence that the design was properlyaccomplished. These records include the final-design output and any revisions thereto,as well as records of the important design steps (e.g., calculations, analyses, andcomputer programs) and the sources of input that support the final output.

Plant design drawings reflect the properly reviewed and approved configuration of the

plant.

2.3.3 Computer Application and Digital Equipment Software

The QAPD governs the development, procurement, testing, maintenance, and use ofcomputer application and digital equipment software when used in safety-relatedapplications and designated nonsafety-related applications. Computer programacceptability is pre-verified or the results verified with the design analysis for eachapplication. Pre-verified computer programs are controlled using a softwareconfiguration management process. NuScale and suppliers are responsible fordeveloping, approving, and issuing procedures, as necessary, to control the use of suchcomputer application and digital equipment software. The procedures require that theapplication software be assigned a proper quality classification and that the associatedquality requirements be consistent with this classification. Each application software andrevision thereto is documented and approved by authorized personnel. The QAP is alsoapplicable to the administrative functions associated with the maintenance and securityof computer hardware where such functions are considered essential in order to complywith other QAP requirements such as QA records.

2.3.4 NQA-1-2008 and NQA-la-2009 addenda, Commitment

In establishing its program for design control and verification, NuScale commits tocompliance with NQA-1-2008 and NQA-la-2009 addenda, Requirement 3, Sections 100through 900, and the standards for computer software in NQA-1-2008 and NQA-la-2009addenda, Part II, Subpart 2.7 and Subpart 2.14 for Quality Assurance requirements forcommercial grade items and services.

2.4 Procurement Document Control

NuScale has established the necessary measures and governing procedures to assurethat purchased items, computer programs, and services are subject to appropriatequality and technical requirements. Procurement documents (e.g., statements of work tobe included in contracts), and any changes thereto shall be subject to the same degreeof control as utilized in the preparation of the original documents. These controls includethe following provisions:

* If original technical or quality assurance requirements cannot be determined, anengineering evaluation is conducted and documented by qualified staff to establish

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appropriate requirements and controls to assure that interfaces, interchangeability,safety, fit, and function, as applicable, are not adversely affected or contrary toapplicable regulatory requirements.

Applicable technical, regulatory, administrative, quality, and reporting requirements(such as specifications, codes, standards, tests, inspections, special processes, and10 CFR 21) are invoked for procurement of items and services. 10 CFR 21requirements for posting, evaluating, and reporting shall be followed and imposed onsuppliers when applicable. Applicable design bases and other requirementsnecessary to assure adequate quality shall be included or referenced in documentsfor procurement of items and services. To the extent necessary, procurementdocuments shall require suppliers to have a documented QA program that isdetermined to meet the applicable requirements of 10 CFR 50, Appendix B asappropriate to the circumstances of procurements (or the supplier may work underNuScale's approved QA program).

Reviews of the technical and quality requirements for inclusion in procurementdocuments shall be performed by personnel who have access to pertinent informationand who have an adequate understanding of those requirements and their intent.

2.4.1 NQA-1-2008 Commitment/Exceptions

In establishing controls for procurement, NuScale commits to compliance with NQA-1-2008, Requirement 4, Sections 100 through 400, with the following clarifications andexceptions:

" With regard to service performed by a supplier, NuScale procurement documentsmay allow the supplier to work under the NuScale QAP, including implementingprocedures, in lieu of the supplier having its own QAP.

" Sections 300 and 400 of Requirement 4 require the review of technical and QualityAssurance Program requirements of procurement documents prior to award of acontract and for procurement document changes (respectively). NuScale may satisfythis requirement through the review of procurement specification when thespecification contains the technical and quality assurance requirements of theprocurement.

* Procurement documents for Commercial Grade Items that will be procured byNuScale for use as safety-related items shall contain technical and qualityrequirements such that the procured item can be appropriately dedicated inaccordance with the NuScale QAPD, Section 7, "Control of Purchased Material,Equipment and Services."

2.5 Instructions, Procedures, and Drawings

NuScale has established the necessary measures and governing procedures to ensurethat activities affecting quality are prescribed by, and performed in accordance with,instructions, procedures, or drawings of a type appropriate to the circumstances andwhich, where applicable, include quantitative or qualitative acceptance criteria toimplement the QAP as described in this document. Such documents are prepared andcontrolled according to Section 2.6 in this document. In addition, means are provided to

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disseminate to the staff instructions of both general and continuing applicability, as wellas those of short-term applicability. Provisions are included for reviewing, updating, andcanceling such procedures.

2.5.1 Procedure Adherence

NuScale's policy is that procedures are followed, and the requirements for use ofprocedures have been established in administrative procedures. Where procedurescannot be followed as written, provisions are established for making changes inaccordance with Section 2.6 in this document. Requirements are established to identifythe manner in which procedures are to be implemented, including identification of thosetasks that require

" the written procedure to be present and followed step-by-step while the task is being

performed.

* the user to have committed the procedure steps to memory.

* verification of completion of significant steps by initials or signatures or use of check-off lists.

Procedures that are required to be present and referred to directly are those developedfor extensive or complex jobs where reliance on memory cannot be trusted, tasks areinfrequently performed, and tasks where steps must be performed in a specifiedsequence.

2.5.2 Procedure Content

The established measures address the applicable content of procedures as described inthe introduction to Part II of NQA-1-2008. In addition, procedures governing tests,inspections, operational activities, and maintenance will include, as applicable, initialconditions and prerequisites for the performance of the activity.

2.5.3 NQA-1-2008 Commitment

In establishing procedural controls, NuScale commits to compliance with NQA-1-2008,Requirement 5, Section 100.

2.6 Document Control

NuScale has established the necessary measures and governing procedures to controlthe preparation of, issuance of, and changes to documents that specify qualityrequirements or prescribe how activities affecting quality, including organizationalinterfaces, are controlled to assure that correct documents are being employed. Thecontrol systems (including electronic systems used to make documents available) aredocumented and provide for the following:

* identification of documents to be controlled and their specified distribution

* a method to identify the correct document (including revision) to be used and controlof superseded documents

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* identification of assignment of responsibility for preparing, reviewing, approving, andissuing documents

* review of documents for adequacy, completeness, and correctness prior to approvaland issuance

* a method for providing feedback from users to continually improve procedures andwork instructions

* coordinating and controlling interface documents and procedures

The types of documents to be controlled include

* drawings, such as design

* engineering calculations

* design specifications

* purchase orders and related documents

* vendor-supplied documents

* audit, surveillance, and quality verification/inspection procedures

• inspection and test reports

* instructions and procedures for activities covered by the QAP

• technical specifications

* nonconformance reports and corrective action reports

2.6.1 Review and Approval of Documents

Documents are reviewed for adequacy by qualified persons other than the preparer.Procedures for design and installation are also reviewed by the quality group to ensurequality assurance measures have been appropriately applied. The documented reviewsignifies concurrence. Prior to issuance or use, documents including revisions thereto,are approved by the designated authority. A listing of all controlled documents identifyingthe current approved revision or date is maintained so personnel can readily determinethe appropriate document for use.

2.6.2 Changes to Documents

Changes to documents, other than those defined in implementing procedures as minorchanges, are reviewed and approved by the same organizations that performed theoriginal review and approval, unless other organizations are specifically designated. Thereviewing organization has access to pertinent background data or information uponwhich to base their approval. Minor changes to documents, such as inconsequentialeditorial corrections, do not require that the revised documents receive the same reviewand approval as the original documents. To avoid a possible omission of a requiredreview, the type of minor changes that do not require such a review and approval, andthe persons who can authorize such a classification shall be clearly delineated inimplementing procedures.

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2.6.3 NQA-1-2008 Commitment

In establishing provisions for document control, NuScale commits to compliance withNQA-1-2008, Requirement 6, Sections 100 through 300.

2.7 Control of Purchased Material, Equipment, and Services

NuScale has established the necessary measures and governing procedures to controlthe procurement of items and services to assure conformance with specifiedrequirements. Such control provides for the following, as appropriate: source evaluationand selection; evaluation of objective evidence of quality furnished by the supplier;source inspection, audit, and examination of items or services.

2.7.1 Acceptance of Item or Service

NuScale establishes and implements measures to assess the quality of purchased itemsand services, whether purchased directly or through contractors, at intervals and to adepth consistent with the item's or service's importance to safety, complexity, quantity,and frequency of procurement. Verification actions include testing, as appropriate.Verifications occur at the appropriate phases of the procurement process, including, asnecessary, verification of activities of suppliers below the first tier.

Measures to assure the quality of purchased items and services include the following, asapplicable:

* Items are inspected, identified, and stored to protect against damage, deterioration,or misuse.

* Prospective suppliers of safety-related items and services are evaluated to assurethat only qualified suppliers are used. Qualified suppliers are audited on a triennialbasis. In addition, if a subsequent contract or a contract modification significantlyenlarges the scope of, or changes the methods or controls for activities performed bythe same supplier, an audit of the modified requirements is conducted, thus startinga new triennial period. NuScale may utilize audits conducted by outsideorganizations for supplier qualification provided that the scope and adequacy of theaudits meet NuScale requirements. Documented annual evaluations are performedfor qualified suppliers to assure they continue to provide acceptable products andservices. Industry programs such as those applied by ASME are used as input or thebasis for supplier qualification whenever appropriate. The results of the reviews arepromptly considered for effect on a supplier's continued qualification andadjustments made as necessary (including corrective actions, adjustments ofsupplier audit plans, and input to third-party auditing entities, as warranted). Inaddition, results are reviewed periodically to determine if, as a whole, they constitutea significant condition adverse to quality requiring additional action.

* Provisions are made for accepting purchased items and services, such as sourceverification, receipt inspection, certificates of conformance, and document reviews(including Certified Material Test Report/Certificate). Acceptance actions anddocuments are established by the purchaser with appropriate input from the supplierand are completed to ensure that procurement, inspection, and test requirements, as

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applicable, have been satisfied before relying on the item to perform its intendedsafety function.

" Controls are imposed for the selection, determination of suitability for intended use(critical characteristics), evaluation, receipt, and acceptance of commercial gradeservices or items to assure they will perform satisfactorily in service in safety-relatedapplications.

* If there is insufficient evidence of implementation of a QA program, the initialevaluation is of the existence of a QA program addressing the scope of services tobe provided. The initial audit is performed after the supplier has completed sufficientwork to demonstrate that its organization is implementing a QA program.

2.7.2 NQA-1-2008 and NQA-la-2009, Commitment/Exceptions

* In establishing procurement verification controls, NuScale commits to compliancewith NQA-1-2008 and NQA-la-2009 addenda, Requirement 7, Sections 100 through800, with the following clarifications and exceptions:

* NQA-1-2008, Sections 200 & 503(f)

- NuScale considers that other 10 CFR 50 licensees, authorized nuclear inspectionagencies, National Institute of Standards and Technology, or other state andfederal agencies that may provide items or services to NuScale are not requiredto be evaluated or audited.

- When purchasing commercial grade calibration or testing services from alaboratory holding accreditation by an accrediting body recognized by theInternational Laboratory Accreditation Cooperation (ILAC) Mutual RecognitionArrangement (MRA), commercial grade surveys need not be performed providedeach of the following conditions are met:

A documented review of the supplier's accreditation is performed andincludes a verification of the following:

- The calibration or test laboratory holds accreditation by an accreditingbody recognized by the ILAC MRA. The accreditation encompassesISO/IEC-17025:2005, "General Requirements for the Competence ofTesting and Calibration Laboratories."

- For procurement of calibration services, the published scope ofaccreditation for the calibration laboratory covers the neededmeasurement parameters, ranges, and uncertainties.

- For procurement of testing services, the published scope of accreditationfor the test laboratory covers the needed testing services, including testmethodology and tolerances/uncertainty.

The purchase documents require that

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

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- As-found calibration data must be reported in the certificate of calibrationwhen calibrated items are found to be out-of-tolerance (for calibrationservices only).

- The equipment/standards used to perform the calibration must beidentified in the certificate of calibration (for calibration services only).

- The customer must be notified of any condition that adversely impacts thelaboratory's ability to maintain the scope of accreditation.

- Additional technical and quality requirements, as necessary, based upona review of the procured scope of services, which may include, but arenot necessarily limited to, tolerances, accuracies, ranges, and industrystandards.

It is validated, at receipt inspection, that the laboratory's documentationcertifies that

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

- The purchase order requirements are met.

" In establishing commercial grade items requirements, NuScale commits tocompliance with NQA-la-2009, Requirement 7, Section 700, and Subpart 2.14.

* NuScale will assume 10 CFR Part 21 reporting responsibility for commercial itemsand services that NuScale dedicates for use in safety-related applications.

2.8 Identification and Control of Materials, Parts, and Components

Necessary measures and governing procedures will be established to identify andcontrol items to prevent the use of incorrect or defective items. This includes controls forconsumable materials and items with limited shelf life. The identification of items ismaintained throughout fabrication, erection, installation and use so that the item can betraced to its documentation, consistent with the item's effect on safety. Identificationlocations and methods are selected so as not to affect the function or quality of the item.

In establishing provisions for identification and control of items, NuScale commits tocompliance with NQA-1-2008, Requirement 8, Sections 100 through 300.

2.9 Control of Special Processes

Necessary measures and governing procedures will be established to assure thatspecial processes that require interim process controls to assure quality, such aswelding, heat treating, and nondestructive examination, are controlled. These provisionsinclude assuring that special processes are accomplished by qualified personnel usingqualified procedures and equipment. Personnel are qualified and special processes areperformed in accordance with applicable codes, standards, specifications, criteria, orother specially established requirements. Special processes are those where the resultsare highly dependent on the control of the process or the skill of the operator, or both,

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and for which the specified quality cannot be fully and readily determined by inspectionor test of the final product.

2.9.1 NQA-1-2008 Commitment

In establishing provisions for control of special processes, NuScale commits tocompliance with NQA-1-2008, Requirement 9, Sections 100 through 400.

2.10 Inspection

Necessary measures and governing procedures will be established to implementinspections that assure items, services, and activities affecting safety meet establishedrequirements and conform to applicable documented specifications, instructions,procedures, and design documents. Inspection may also be applied to items, services,and activities affecting plant reliability and integrity. Types of inspections may includethose verifications related to procurement, such as source, in-process, final, and receiptinspection activities. Inspections are carried out by properly qualified personsindependent of those who performed or directly supervised the work. Inspection resultsare documented.

2.10.1 Inspection Program

The inspection program establishes inspections (including surveillance of processes), asnecessary, to verify quality

* at the source of supplied items or services

* in-process during fabrication at a supplier's facility or at a NuScale facility

* for final acceptance of fabricated and/or installed items

* upon receipt of items involved in design development testing

The inspection program establishes requirements for planning inspections, including theidentification of the group or discipline responsible for performing the inspection,establishing inspection hold points, determining applicable acceptance criteria,determining the frequency of inspection to be applied, and identifying any special toolsneeded to perform the inspection. Inspection planning is performed by personnelqualified in the discipline related to the inspection and may include qualified inspectorsor engineers. Inspection plans are based on, as a minimum, the importance of the itemto the safety of the facility, the complexity of the item, technical requirements to be met,and design specifications. Where significant changes in inspection activities for thefacilities are to occur, management responsible for the inspection programs evaluate theresource and planning requirements to ensure effective implementation of the inspectionprogram.

Inspection program documents establish requirements for performing the plannedinspections and documenting required inspection information such as rejection,acceptance, re-inspection results, and the person(s) performing the inspection.

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Inspection results are documented by the inspector, reviewed by authorized personnelqualified to evaluate the technical adequacy of the inspection results, and controlled byinstructions, procedures, and drawings.

2.10.2 Inspector Qualification

NuScale, suppliers and subcontractors shall, where applicable, establish a qualificationprogram for personnel performing quality inspections. The qualification programrequirements are described in Section 2.2 in this document. These qualificationprograms are applied to individuals performing quality inspections regardless of thefunctional group where they are assigned.

2.10.3 NQA-1-2008 Commitment/Exceptions

In establishing inspection requirements, NuScale commits to compliance with NQA-1-2008, Requirement 10, Sections 100 through 800 and Subparts 2.4, 2.5, and 2.8 forestablishing appropriate inspection requirements

2.11 Test Control

NuScale has established the necessary measures and governing procedures todemonstrate that items subject to the provisions of the QAPD will perform satisfactorilyin service. These measures and governing procedures include criteria for determiningwhen testing is required to demonstrate that performance of plant systems is inaccordance with design. Tests are performed in accordance with applicable proceduresthat include, consistent with the effect on safety,

* instructions and prerequisites to perform the test

* use of proper test equipment

* acceptance criteria

* mandatory verification points as necessary to confirm satisfactory test completion

Test results are documented and evaluated by the organization performing the test andreviewed by a responsible authority to assure that the test requirements have beensatisfied. If acceptance criteria are not met, retesting is performed as needed to confirmacceptability following correction of the system or equipment deficiencies that causedthe failure.

Tests are performed and results documented in accordance with applicable technicaland regulatory requirements, including ensuring appropriate retention of test data inaccordance with the records requirements of the QAPD. Personnel who perform orevaluate tests are qualified in accordance with the requirements established in Section2.2 in this document.

2.11.1 NQA-la-2009 addenda, Commitment for non-Computer Program Testing

In establishing provisions for testing, NuScale commits to compliance with NQA-la-2009addenda, Requirement 11, Sections 100 through 300, 500, 600 and 601.

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2.11.2 NQA-1-2008 and NQA-la-2009 addenda, Commitment for Computer ProgramTesting

NuScale establishes and implements provisions to assure that computer software usedin applications affecting safety is prepared, documented, verified, tested, and used suchthat the expected output is obtained and configuration control maintained. To this end,NuScale commits to compliance with the requirements of NQA-la-2009 addenda,Requirement 11, Sections 100, 200, 400, 600 and 602, and Subpart 2.7 to establish theappropriate provisions in addition to the commitment to NQA-1-2008, Requirement 3.

2.12 Control of Measuring and Test Equipment

NuScale has established the necessary measures and governing procedures to controlthe calibration, maintenance, and use of Measuring and Test equipment (M&TE) thatprovides information important to safe plant operation. The provisions of suchprocedures cover equipment such as indicating and actuating instruments and gauges,tools, reference and transfer standards, and nondestructive examination equipment. Thesuppliers of commercial grade calibration services are controlled as described in Section2.7 in this document.

2.12.1 NQA-1-2008 Commitment/Exceptions

In establishing provisions for control of measuring and test equipment, NuScale commitsto compliance with NQA-1-2008, Requirement 12, Sections 100 through 400, with thefollowing clarification and exception:

* The out of calibration conditions described in Section 303.2 refers to when the M&TEis found to be out of the required accuracy limits (i.e., out of tolerance) duringcalibration and not overdue for calibration.

* Measuring and test equipment are not required to be marked with the calibrationstatus, as described in Section 303.6, where it is impossible or impractical due toequipment size or configuration (such as the label will interfere with operation of thedevice) provided the required information is maintained in suitable documentationtraceable to the device. This exception also applies to the calibration labelingrequirement stated in NQA-1-2008, Subpart 2.4 (See Section 7.2.1 of ANSI/IEEEStd. 336-1985).

2.13 Handling, Storage, and Shipping

Necessary measures and governing procedures will be established to control thehandling, storage, packaging, shipping, cleaning, and preservation of items to preventinadvertent damage or loss, and to minimize deterioration. These provisions includespecific procedures, when required to maintain acceptable quality of the items importantto the safe operations of the plant. Items are appropriately marked and labeled duringpackaging, shipping, handling and storage to identify, maintain, and preserve the item'sintegrity and indicate the need for special controls. Special controls (such as containers,shock absorbers, accelerometers, inert gas atmospheres, specific moisture contentlevels, and temperature levels) are provided when required to maintain acceptablequality.

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Special or additional handling, storage, shipping, cleaning and preservationrequirements are identified and implemented as specified in procurement documentsand applicable procedures. Where special requirements are specified, the items andcontainers (where used) are suitably marked.

Special handling tools and equipment are used and controlled as necessary to ensuresafe and adequate handling. Special handling tools and equipment are inspected andtested at in accordance with procedure at specified time intervals, or prior to use.

Operators of special handling and lifting equipment are experienced or trained in the usethe equipment. Where required, NuScale complies with applicable hoisting, rigging, andtransportation regulations and codes.

2.13.1 Housekeeping

Housekeeping practices are established to account for conditions or environments thatcould affect the quality of structures, systems, and components. This includes control ofcleanliness of facilities and materials, fire prevention and protection, disposal ofcombustible material and debris, control of access to work areas, and protection ofequipment. Housekeeping practices help assure that only proper materials, equipment,processes, and procedures are used and that the quality of items is not degraded.Necessary procedures or work instructions, are developed and used.

2.13.2 NQA-1 Commitment/Exceptions

In establishing provisions for handling, storage, and shipping, NuScale commits tocompliance with NQA-1 -2008, Requirement 13.

2.14 Inspection, Test, and Operating Status

Necessary measures and governing procedures will be established to identify theinspection, test, and operating status of items and components subject to the provisionsof the QAPD in order to maintain personnel and reactor safety and avoid inadvertentoperation of equipment. Where necessary to preclude inadvertent bypassing ofinspections or tests, or to preclude inadvertent operation, these measures require theinspection, test, or operating status be verified before release, fabrication, receipt,installation, test, or use. These measures also establish the necessary authorities andcontrols for the application and removal of status indicators or labels.

In addition, temporary design changes (temporary modifications), such as temporarybypass lines, electrical jumpers and lifted wires, and temporary trip-point settings, willbe controlled by procedures that include requirements for appropriate installation andremoval, independent/concurrent verifications, and status tracking.

Administrative procedures will also describe the measures taken to control altering thesequence of required tests, inspections, and other operations. Review and approval forthese actions is subject to the same control as taken during the original review andapproval of tests, inspections, and other operations.

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2.14.1 NQA-1 Commitment

In establishing measures for control of inspection, test, and operating status, NuScalecommits to compliance with NQA-1-2008, Requirement 14, Section 100.

2.15 Nonconforming Materials, Parts, or Components

NuScale has established the necessary measures and governing procedures to controlitems, including services that do not conform to specified requirements to preventinadvertent use. Instructions require that the individual discovering a nonconformanceidentify, describe, and document the nonconformance in accordance with therequirements of Section 2.16 of this document. Controls provide for identification,documentation, evaluation, segregation (when practical), disposition of nonconformingitems, and notification to affected organizations. Controls are provided to addressconditional release of nonconforming items for use on an at-risk basis prior to resolutionand disposition of the nonconformance, including maintaining identification of the itemand documenting the basis for such release.

Conditional release of nonconforming items requires the approval of management.Nonconformances are corrected or resolved before relying on the item to perform itsintended safety function. Nonconformances are evaluated for impact on operability ofsafety-related (Q) structures, systems, and components to assure that the final conditiondoes not adversely affect safety, operation, or maintenance of the item or service.Nonconformances to design requirements, dispositioned repair, or use-as-is are subjectto design control measures commensurate with those applied to the original design.Nonconformance dispositions are reviewed for adequacy, analysis of quality trends, andreports provided to the designated management. Significant trends are reported tomanagement in accordance with NuScale procedures, regulatory requirements, andindustry standards.

2.15.1 Interface with the Reporting Program

NuScale has appropriate interfaces between the QAP for identification and control ofnonconforming items, including services, and the non-QA reporting programs to satisfythe requirements of 10 CFR 52 and 10 CFR 21.

2.15.2 NQA-1-2008 Commitment

In establishing measures for nonconforming items, including services, NuScale commitsto compliance with NQA-1-2008, Requirement 15, Sections 100 through 400.

2.16 Corrective Action

NuScale has established the necessary measures and governing procedures topromptly identify, control, document, classify, correct and verify conditions adverse toquality. NuScale procedures assure that corrective actions are documented and initiatedfollowing the determination of conditions adverse to quality in accordance with regulatoryrequirements and applicable quality standards. NuScale procedures require personnel toidentify known conditions adverse to quality. When complex issues arise where it cannotbe readily determined if a condition adverse to quality exists, NuScale documents

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establish the requirements for documentation and timely evaluation of the issue. Reportsof conditions adverse to quality are analyzed to identify trends. Significant conditionsadverse to quality and significant adverse trends are documented and reported tomanagement. In the case of a significant condition adverse to quality, the cause isdetermined and actions to preclude recurrence are taken.

In the case of suppliers working on safety-related activities, or other similar situations,NuScale may delegate specific responsibilities for corrective actions, but NuScalemaintains responsibility for the effectiveness of corrective action measures.

2.16.1 Interface with the Reporting Program

NuScale has appropriate interfaces between the QAP for corrective actions and the non-QA reporting program to satisfy the requirements of 10 CFR 52 and 10 CFR 21.

2.16.2 NQA-1-2008 Commitment

In establishing provisions for corrective action, NuScale commits to compliance withNQA-1-2008, Requirement 16, Section 100.

2.17 Quality Assurance Records

NuScale has the necessary measures and governing procedures to ensure thatsufficient records of items and activities affecting quality are developed, reviewed,approved, issued, used, and revised to reflect completed work. The provisions of suchprocedures establish the scope of the records retention program for NuScale andinclude requirements for records administration including receipt, preservation, retention,storage, safekeeping, retrieval, access controls, user privileges, and final disposition.

2.17.1 Record Retention

Measures are established that ensure that sufficient records of completed items andactivities affecting quality are appropriately stored. Records of activities for design,engineering, procurement, inspection, test, and audits and their retention times aredefined in appropriate procedures. The records and retention times are based onRegulatory Position C.1 of Regulatory Guide 1.28, Revision 4, and NQA-la-2009addenda, Nonmandatory Appendix 17A-1, Section 200 as applicable. In all cases wherestate, local, or other agencies have more restrictive requirements for record retention,those requirements will be met.

2.17.2 Electronic Records

When using optical disks for electronic records storage and retrieval systems, NuScalecomplies with the NRC guidance in Generic Letter 88-18, "Plant Record Storage onOptical Disks." NuScale manages the storage of QA Records in electronic mediaconsistent with the intent of RIS 2000-18 and associated NIRMA Guidelines TG 11-1998,TG15-1998, TG16-1998, and TG21-1998.

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2.17.3 NQA-1-2008 Commitment and Exceptions

In establishing provisions for records, NuScale commits to compliance with NQA-1-2008,Requirement 17, Sections 100 through 800.

2.18 Audits

NuScale has established the necessary measures and governing procedures toimplement audits to verify that activities covered by the QAPD are performed inconformance with the requirements established. The audit programs are reviewed foreffectiveness as a part of the overall audit process.

2.18.1 Performance of Audits

Internal audits of selected aspects of the project activities are performed with afrequency commensurate with the safety significance of the activity and in a manner thatassures that audits of safety-related activities are completed. During the early portions ofproject activities, audits will focus on areas including, but not limited to design, documentcontrol, procurement, testing and corrective action. Functional areas of an organization'sQA program for auditing include, at a minimum, verification of compliance andeffectiveness of implementation of internal rules and procedures (e.g., design,procurement, surveillance, test); regulations; programs for training, retraining, andpersonnel qualification; and corrective actions, including associated recordkeeping.

The audits are scheduled on a formal, preplanned audit schedule. The audit system isreviewed periodically and revised as necessary to assure coverage commensurate withcurrent and planned activities. Additional audits may be performed as deemednecessary by management. The scope of the audit is determined by the quality statusand safety importance of the activities being performed. These audits are conducted bytrained personnel not having direct responsibilities in the area being audited and inaccordance with preplanned and approved audit plans or checklists, under the directionof a qualified lead auditor and the cognizance of the NuScale QAD.

The NuScale QAD is responsible for conducting periodic internal and external audits.Internal audits are conducted to determine the adequacy of programs and procedures(by representative sampling), and to determine if they are meaningful and comply withthe overall QAP. External audits determine the adequacy of supplier and contractorquality assurance programs and are issued to the management of the auditedorganization and applicable management.

The results of each audit are reported in writing to the COO/CNO and responsiblefunctional manager, as appropriate. Additional internal distribution is provided toresponsible management levels.

Management responds to all audit findings and initiates corrective action whendetermined necessary. When corrective action measures are determined to benecessary, documented follow-up of applicable areas through inspections, reviews, re-audits, or other appropriate means is conducted to verify implementation andeffectiveness of corrective actions.

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Audits of suppliers of safety-related components and/or services are conducted asdescribed in Section 2.7.1 in this document.

2.18.2 Internal Audits

Internal audits should be performed in such a manner as to assure that an audit of allapplicable QA program elements is completed for each functional area at least onceeach year or at least once during the life of the activity, whichever is shorter.

Internal audits include verification of compliance and effectiveness of the administrativecontrols established for implementing the requirements of the QAPD. These includeregulations; provisions for training, retraining, qualification, and performance ofpersonnel performing activities covered by the QAP; and observation of the performanceof activities including associated recordkeeping.

2.18.3 NQA-1-2008 Commitment

In establishing the independent audit program, NuScale commits to compliance withNQA-1-2008, Requirement 18, Sections 100 through 800.

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3.0 Part III-Nonsafety-Related Structures, Systems, and Components Quality Control

3.1 Nonsafety-Related Structures, Systems, and, Components-SignificantContributors to Plant Safety

Specific program controls are applied to nonsafety-related SSC, for which 10 CFR 50,Appendix B is not applicable, that are significant contributors to plant safety. The specificprogram controls consistent with applicable sections of the QAPD are applied to thoseitems in a selected manner and targeted at those characteristics or critical attributes thatrender the SSC a significant contributor to plant safety.

The following clarify the applicability of the QA Program to the nonsafety-related SSCand related activities, including the identification of exceptions to the QA Program fornonsafety-related SSC that are described in Sections 2.1 through 2.18 of this document.

3.1.1 Organization

The verification activities described in this section may be performed by the NuScale lineorganization. The QA organization described in Section 2.1 is not required to performthese functions.

3.1.2 Quality Assurance Program

NuScale QA requirements for nonsafety-related SSCs are established in the QAPD andappropriate procedures. Suppliers of these SSCs or related services describe the qualitycontrols applied in appropriate procedures. A new or separate QA program is notrequired.

3.1.3 Design Control

NuScale has design control measures to ensure that the established designrequirements are included in the design. These measures ensure that applicable designinputs are included or correctly translated into the design documents and deviations fromthose requirements are controlled. Design verification is provided through the normalsupervisory review of the designer's work.

3.1.4 Procurement Document Control

Procurement documents for items and services obtained by or for NuScale include orreference documents describing applicable design bases, design requirements, andother requirements necessary to ensure component performance. The procurementdocuments are controlled to address deviations from the specified requirements.

3.1.5 Instructions, Procedures, and Drawings

NuScale provides documents such as, but not limited to, written instructions, plantprocedures, drawings, vendor technical manuals, and special instructions in work ordersto direct the performance of activities affecting quality. The method of instructionemployed provides an appropriate degree of guidance to the personnel performing theactivity to achieve acceptable functional performance of the SSC.

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3.1.6 Document Control

NuScale controls the issuance and change of documents that specify qualityrequirements or prescribe activities affecting quality to ensure that correct documentsare used. These controls include review and approval of documents, identification of theappropriate revision for use, and measures to preclude the use of superseded orobsolete documents.

3.1.7 Control of Purchased Items and Services

NuScale employs measures, such as inspection of items or documents upon receipt oracceptance testing, to ensure that all purchased items and services conform toappropriate procurement documents.

3.1.8 Identification and Control of Purchased Items

NuScale employs measures where necessary, to identify purchased items and preservetheir functional performance capability. Storage controls take into account appropriateenvironmental, maintenance, or shelf life restrictions for the items.

3.1.9 Control of Special Processes

NuScale employs process and procedure controls for special processes, includingwelding, heat treating, and nondestructive testing. These controls are based onapplicable codes, standards, specifications, criteria, or other special requirements for thespecial process.

3.1.10 Inspection

NuScale requires use of documented instructions to ensure necessary inspections areperformed to verify conformance of an item or activity to specified requirements or toverify that activities are satisfactorily accomplished. These inspections may beperformed by knowledgeable personnel in the line organization. Knowledgeablepersonnel can be from the same discipline and have experience related to the workbeing inspected.

3.1.11 Test Control

NuScale employs measures to identify required testing that demonstrates thatequipment conforms to design requirements. These tests are performed in accordancewith test instructions or procedures. The test results are recorded, and authorizedindividuals evaluate the results to ensure that test requirements are met.

3.1.12 Control of Measuring and Test Equipment

NuScale employs measures to control M&TE use, calibration, and adjustment at specificintervals or prior to use.

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3.1.13 Handling, Storage, and Shipping

NuScale employs measures to control the handling, storage, cleaning, packaging,shipping, and preservation of items to prevent damage or loss and to minimizedeterioration. These measures include appropriate marking or labels, and identificationof any special storage or handling requirements.

3.1.14 Inspection, Test, and Operating Status

NuScale employs measures to identify items that have satisfactorily passed requiredtests and inspections and to indicate the status of inspection, test, and operability asappropriate.

3.1.15 Control of Nonconforming Items

NuScale employs measures to identify and control items that do not conform to specifiedrequirements to prevent their inadvertent installation or use.

3.1.16 Corrective Action

NuScale employs measures to ensure that failures, malfunctions, deficiencies,deviations, and nonconformances are properly identified, reported, and corrected.

3.1.17 Records

NuScale employs measures to ensure records are prepared and maintained to furnishevidence that the above requirements for design, procurement, document control,inspection, and test activities have been met.

3.1.18 Audits

NuScale employs measures for line management to periodically review and documentthe adequacy of processes, including taking any necessary corrective action. Auditsindependent of line management are not required. Line management is responsible fordetermining whether reviews conducted by line management or audits conducted by anyorganization independent of line management are appropriate. If performed, audits areconducted and documented to verify compliance with design and procurementdocuments, instructions, procedures, drawings, and inspection and test activities. Wherethe measures of this section (Section 3.0) are implemented by the same programs,processes, or procedures as the comparable activities of Section 2.0, the auditsperformed under the provisions of Section 2.0 may be used to satisfy the reviewrequirements of this section (Section 3.1.18).

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3.2 Nonsafety-Related Structure, System, and Components Credited for RegulatoryEvents

The following criteria apply to fire protection (10 CFR 50.48), anticipated transientswithout scram (ATWS) (10 CFR 50.62), and the station blackout (SBO) (10 CFR 50.63)SSC that are not safety-related:

* NuScale implements quality requirements for the fire protection system inaccordance with Regulatory Position 1.7, "Quality Assurance," in Regulatory Guide1.189 Revision 2, October 2009, "Fire Protection for Operating Nuclear PowerPlants."

" NuScale implements the quality requirements for ATWS equipment in accordancewith Generic Letter 85-06, "Quality Assurance Guidance for ATWS Equipment ThatIs Not Safety Related."

* NuScale implements quality requirements for SBO equipment in accordance withRegulatory Position 3.5, "Quality Assurance and Specific Guidance for SBOEquipment That Is Not Safety Related," and Appendix A, "Quality AssuranceGuidance for Nonsafety Systems and Equipment," in Regulatory Guide 1.155Revision 0 August 1988, "Station Blackout."

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4.0 Part IV-Regulatory Commitments

4.1 Nuclear Regulatory Commission Regulatory Guides and Quality AssuranceStandards

This section identifies the NRC Regulatory Guides (RG) and the other quality assurancestandards that have been selected to supplement and support the NuScale QAP.NuScale complies with these standards to the extent described or referenced in theScope/Applicability Section 1.1.1, as they apply to Design Certification activities. SeeFinal Safety Analysis Report (FSAR) Chapter 1 of the NuScale DC application for a fullevaluation of conformance with the guidance in NRC RGs in effect six months prior tothe submittal date of the application. Commitment to a particular RG or standard doesnot constitute a commitment to other RGs or standards that may be referenced therein.

Regulatory Guides

4.1.1 U.S Nuclear Regulatory Commission, "Qualification and Training of Personnel forNuclear Power Plants," Regulatory Guide 1.8, Revision 3, ADAMS Accession No.ML003706932.

Regulatory Guide 1.8 provides guidance that is acceptable to the NRC staffregarding qualifications and training for nuclear power plant personnel.

NuScale identifies conformance and exceptions for the applicable regulatoryposition guidance provided in this regulatory guide in FSAR Chapter 1.

4.1.2 U.S Nuclear Regulatory Commission, "Quality Group Classifications andStandards for Water-, Steam-, and Radioactive-Waste-Containing Componentsof Nuclear Power Plants," Regulatory Guide 1.26, Revision 4, ADAMS AccessionNo. ML070290283.

Regulatory Guide 1.26 defines classification of systems and components.

The NuScale Power Plant design is unique in configuration and safety featurefunctions. The design includes components not found in existing standard designreactors (e.g., containment pressure vessel) and does not include somecomponents found in existing standard designs. Examples of features not foundin the NuScale design include, but are not limited to, reactor coolant pumps, coldlegs, hot legs, pressurizer surge line, core make-up tanks and piping, directvessel injection lines, passive residual heat removal heat exchangers, in-containment storage tanks, and hydrogen recombiners. These unique designfeatures and the equivalence of their design safety functions, includingapplication to committed regulatory guidance, will be detailed in Chapter 3 of theFSAR.

4.1.3 NuScale identifies conformance and exceptions for the applicable regulatoryposition guidance as indicated in the NuScale DC FSAR, Chapter 1, U.S.Nuclear Regulatory Commission, "Quality Assurance Program Requirements

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(Design and Construction)," Regulatory Guide 1.28, Revision 4, ADAMSAccession No. ML100160003.

Regulatory Guide 1.28 describes a method acceptable to the NRC staff forcomplying with the provisions of Appendix B with regard to establishing andimplementing the requisite quality assurance program for the design of nuclearpower plants.

NuScale commits to the applicable regulatory position guidance as indicated inthe NuScale DC FSAR, Chapter 1.

U.S. Nuclear Regulatory Commission, "Seismic Design Classification,"

Regulatory Guide 1.29, Revision 4, ADAMS Accession No. ML070310052.

Regulatory Guide 1.29 defines systems required to withstand a safeshutdown earthquake.

NuScale commits to the applicable regulatory position guidance as indicatedin the NuScale DC FSAR, Chapter 1.

Standards

4.1.4 American Society of Mechanical Engineers, "Quality Assurance Requirements forNuclear Facility Applications," ASME NQA-1-2008 and NQA-la-2009 addenda,Edition, New York, NY.

NuScale commits to NQA-1-2008 and NQA-la-2009 addenda, Parts I and II asdescribed in Section 2.0 in this document with specific identification of exceptionsor clarification. NuScale commits to NQA-1-2008 with NQA-la-2009 addenda,Part III only as specifically noted in Section 2.0 of this document.

4.1.5 Nuclear Information and Records Management Association, Inc. (NIRMA)Technical Guides (TGs).

4.1.6 NuScale commits to NIRMA TGs as described in Section 2.1.7 in this document.

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