Holtec International, HI-2135649-NP, Rev. 1, 'Topical ... · Holtec Report HI-2135649-NP Topical Report On The Quality Assurance Program for Holtec International's IOCFR 50 & 52 Projects

Holtec Report HI-2135649-NP

Topical ReportOn

The Quality Assurance Programfor

Holtec International'sIOCFR 50 & 52 Projects

REVISION 1 DATE OF ADOPTION: July 15, 2013

Holtec Document ID HI-2135649-NP

DOCUMENT STATUS: NON-PROPRIETARY

REVISION TYPE: Complete Revision L7

Revisions Designated with Bars Z

This Topical Report provides the commitments and requirements for implementationof Holtec International's QA Program for the design of Small Module Reactors underthe rules of 10 CFR part 50 or part 52. In this format, the Topical Report providesmandatory programmatic requirements under each of the applicable eighteen discretegeneral design criteria arranged in eighteen sections listed in the Table of Contentsherein. Additional commitments that are beyond the specific purview of the eighteencriteria but are deemed to be necessary for ensuring comprehensive regulatorycompliance are included in this Topical Report.

HOLTEC INTERNATIONAL

DOCUMENT ISSUANCE AND REVISION STATUS 1

DOCUMENT NAME: TOPICAL REPORT FOR PART 50/52 QA PROGRAM

DOCUMENT NO.: HI-2135649-NP CATEGORY: OI GENERIC

PROJECT NO.: 001 PROJECT SPECIFIC

Rev. Date Author'sNo.2 Approved Initials VIR #

1 7/15/2013 M. Soler 142499

DOCUMENT CATEGORIZATION

In accordance with the Holtec Quality Assurance Manual and associated Holtec Quality Procedures(HQPs), this document is categorized as a:

El Calculation Package3 (Per HQP 3.2)

Fi Design Criterion Document (Per HQP 3.4)

E] Technical Report (Per HQP 3.2)(Such as a Licensing Report)

I-] Design Specification (Per HQP 3.4)

W1 Other (Specify): Topical ReportDOCUMENT FORMATTING

The formatting of the contents of this document is in accordance with the instructions of HQP 3.2 or 3.4except as noted below:

DECLARATION OF PROPRIETARY STATUS

W] Nonproprietary M" Holtec Proprietary [NH Privileged Intellectual Property (PIP)

SUMMARY OF REVISIONS

Revision 1: 1) Modified text in various sections to clearly identify that this TopicalReport is specific to design and testing activities to support certification of a SmallModule Reactor; 2) In Part III added some text to several sections that would apply forsome testing activities

ABSTRACT

This Topical Report provides the description of Holtec International's QualityAssurance Program (QAP) for design and testing activities necessary for certification ofSmall Module Reactors.. The QAP has been developed in accordance with quality assurancerequirements set forth in 10CFR50 Appendix B and NQA-1; 2008 edition with 2009 addendaand Regulatory Guide 1.28, Revision 4 and per the guidance set forth in NUREG-0800.

The Topical Report follows the additional guidance of NEI 11-04 (Nuclear Generation QualityAssurance Program Description). Pursuant to the NEI guidance document, the TopicalReport contains four primary parts, namely; 1.0: Introduction and Scope; 2.0 QualityAssurance Program Description; 3.0 Non-Safety Related Structures, Systems and componentQuality Control; and 4.0 Regulatory Commitments.

POLICY STATEMENT

Holtec International performs design and testing activities of Small Module Reactors forcertification. These activities shall be controlled and performed in a manner that will ensurethe health and safety of the public and workers. These activities shall be performed incompliance with the requirements of the Code of Federal Regulations (CFR), the applicableNuclear Regulatory Commission (NRC) Facility Operating License(s) and applicable laws andregulations of the state and local governments.

The Holtec Quality Assurance Manual (QAM) along with the associated implementingprocedures provide for control of Quality Assurance Program (QAP) activities related todesign and licensing 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 perform satisfactorilyin service. The QAP is also be applied to certain activities that are not safety-related, butsupport safe plant operations, or where other NRC guidance establishes programrequirements.

The QAM is the top-level policy document that establishes the manner in which quality is tobe achieved and presents Holtec's corporate approach for achievement and assurance ofquality. The commitments in the QAM are expounded into actionable instructions in a seriesof implementing procedures known as Holtec Quality Procedures (HQPs). Implementingdocuments assign more detailed responsibilities and requirements and define theorganizational interfaces involved in conducting activities within the scope of the QAM. TheVice President of Quality establishes overall expectations for effective implementation of theQuality Assurance Program (QAP) and is responsible for obtaining the desired end result.Compliance with the QAM and implementing documents is mandatory for personnel directlyor indirectly associated with implementation of the Holtec QAP.

Signed,

1(&ýlSinghPresident- Holtec International

July 15th, 2013

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GLOSSARY OF TERMS

Term Description

Company Holtec International

Component A piece of equipment, such as a vessel, piping, pumpvalve, or core support structure, which will becombined with other components to form an assembly.

HQP Holtec Quality Procedure

Inspection A phase of quality control, which, by means ofexamination, observation, or measurements,determines the conformance of materials, supplies,components, parts, appurtenances, systems, processes,or structures to predetermined quality requirements.

Item Any level of unit assembly, including structure,system, subsystems, subassembly, component, part, ormaterial (also includes computer codes in theappropriate context).

M&TE Measurement and Test Equipment

NDE Non-Destructive Examination

NonconformanceA deficiency in characteristic, documentation, orprocedure which renders the quality of an itemunacceptable or indeterminate. Examples ofnonconformances include: physical defects, testfailures, incorrect or inadequate documentation, ordeviation from prescribed processing, inspection, ortest procedures, etc.

NRC Nuclear Regulatory Commission

Part An item on which work is performed and which isattached to, and becomes part of, a component beforecompletion of the component.

Procedure A document that specifies or describes how an activity

Term Descrii)tion

is to be performed. It may include methods to beemployed, equipment or materials to be used, andsequence of operations.

Procurement Documents Contractually binding documents that identify anddefine the requirements which items or services mustmeet in order to be considered acceptable by thepurchaser.

Project Plan Document generated for a project that defines therequirements for the project including, but not limiteddesign basis, scope, QA requirements, etc.

Purchaser The organization or organizations responsible forissuance and administration of a contract, subcontract,or purchase order.

QA Quality Assurance

QAM Quality Assurance Manual

QAP Quality Assurance Program

Quality Assurance All those planned and systematic actions necessary toprovide adequate confidence that an item or a facilitywill perform satisfactorily in service.

Quality Control Those quality assurance actions that provide means tocontrol and measure the characteristics of an item,process, or facility against established requirements.

Safety Related A class of structure, system, component, or part thereofwhose failure could potentially: (a) Compromise theintegrity of the reactor coolant pressure boundary; (b)Compromise the capability to shut down the reactorand maintain it in a safe condition; (c) Compromise thecapability to prevent or mitigate the consequences ofaccidents which could result in significant potentialoffsite exposures; (d) Create a loss of safety function tothe extent that there is a major reduction in the degreeof protection provided to the public health and safety.

Setpoint The value of a process variable at which an engineeredresponse function (usually a safety function) isactuated.

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Term Description

SSC Structure, System, or Component

Supplier Any organization under contract to furnish items orservices. It includes the terms Vendor, Contractor,Subcontractor, Fabricator, and subtier levels of thesewhere appropriate.

Testing The determination or verification of the capability of anitem to meet specified requirements by subjecting theitem to a set of physical, chemical, environmental, oroperating conditions.

Verification An act of confirming, substantiating, and assuring thatan activity or condition has been implemented inconformance with the specified requirements.

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Holtec Document HI-2135649-NP

TABLE OF CONTENTSPO LICY STA TEM EN T ....................................................................................................................................... iG LO SSAR Y O F TER M S .................................................................................................................................... ii

PAR T I IN TR O D U CTIO N ................................................................................................................... ISECTION 1 GEN ERAL ........................................................................................................................ 1

1.1 Scope/Apphcabihty .................................................................................................................. 1PAR T 11 QA P D E TA ILS ........................................................................................................................ 3

SECTIO N 1 ORGAN IZATION ............................................................................................................. 31.1 General ..................................................................................................................................... 31.2 O rganizational Responsibilities of Key Personnel .................................................... 31.3 Quality A ssurance Organizational Independence ................................................................. 51.4 NQA-1 Com m itm ent .................................................................................................................. 5

SECTION 2 Q UA LITY A SSU RAN CE PRO GRAM ............................................................................ 72.1 Responsibilities ........................................................................................................................ 72.2 Delegation of W ork ................................................................................................................... 82.3 Site-specific Safety-Related D esign Basis Activities .................................... ; ........................ 82.4 Periodic Review of the Q uality A ssurance Program .............................................................. 82.5 Issuance and Revision to Quality A ssurance Program ......................................................... 82.6 Personnel Training and Q ualifications .................................................................................. 82.7 N QA -1 Com m itm ent/ Exceptions .......................................................................................... 9

SECTIO N 3 DESIG N CON TROL ...................................................................................................... 113.1 Design Verification ................................................................................................................ 113.2 Design Records ....................................................................................................................... 123.3 Com puter Application and D igital Equipm ent Softw are .................................................... 123.4 Setpoint Control ..................................................................................................................... 123.5 N QA-1 Com m itm ent ............................................................................................................... 13

SECTION 4 PROCUREMENT DOCUMENT CONTROL ............................................................... 144.1 N QA -1 Com m itm ent/ Exceptions ........................................................................................ 14

SECTION 5 INSTRUCTIONS, PROCEDURES, AND DRAWINGS .............................................. 155.1 Procedure Adherence ............................................................................................................. 155.2 Procedure Content ................................................................................................................. 155.3 N QA-1 Com m itm ent ............................................................................................................... 15

SECTIO N 6 D O CU M EN T CO N TROL .......................................................................................... 166.1 Review and Approval of Docum ents ..................................................................................... 166.2 Changes to Docum ents .......................................................................................................... 176.3 N QA-1 Com m itm ent ............................................................................................................... 17

SECTION 7 CONTROL OF PURCHASED MATERIAL, EQUIPMENT, AND SERVICES ......... 187.1 A cceptance of Item or Service ............................................................................................... 187.2 N QA -1 Com m itm ent / Exceptions ........................................................................................ 19

SECTION 8 IDENTIFICATION AND CONTROL OF MATERIALS, PARTS, ANDCOM PON EN TS ...................................................................................................................................... 21

8.1 N QA -1 Com m itm ent .............................................................................................................. 21SECTION 9 CO N TRO L OF SPECIAL PRO CESSES ....................................................................... 22


SE CTIO N 10 IN SPE CTIO N ............................................................................................................. 23SECTION 11 TEST CONTROL ................................................................................................. 24

11.1 NQA- 1 Commitment for Computer Program Testing ...................................................... 2411.2 N Q A -1 C om m itm ent .............................................................................................................. 24

SECTION 12 CONTROL OF MEASURING AND TEST EQUIPMENT .................................. 2512.1 NQA-1 Com m itm ent / Exceptions .................................................................................... 25

SECTION 13 HANDLING, STORAGE, AND SHIPPING ........................................................ 26SECTION 14 INSPECTION, TEST, AND OPERATING STATUS ........................................... 27SECTION 15 NONCONFORMING MATERIALS, PARTS, OR COMPONENTS ................... 28SECTION 16 CORRECTIVE ACTION ....................................................................................... 29

16.1 Interface with the Reporting Program .............................................................................. 2916.2 N Q A -1 C om m itm ent ............................................................................................................... 29

SECTION 17 QUALITY ASSURANCE RECORDS .................................................................. 3017.1 R ecord R eten tion .................................................................................................................... 3017.2 E lectronic R ecords .................................................................................................................. 3017.3 NQA-1 Commitment/ Exceptions .................................................................................... 30

S E C T IO N 18 A U D IT S ...................................................................................................................... 3118.1 P erform ance of A udits ........................................................................................................... 3118.2 N Q A -1 C om m itm ent .............................................................................................................. 32

PART III NONSAFETY-RELATED SSC QUALITY CONTROL ............................................. 33SECTION 1 NONSAFETY-RELATED SSCS - SIGNIFICANT CONTRIBUTORS TO PLANTS A F E T Y . ...................................................................................................................................... 3 3SECTION 2 NON-SAFETY-RELATED SSCS CREDITED FOR REGULATORY EVENTS ........ 36

PART IV REGULATORY COMMITMENTS ................................................................................ 37NRC Regulatory Guides and Quality Assurance Standards ........................................................... 37

R egu latory G u ides: ............................................................................................................................. 37S ta n d a rd s: ........................................................................................................................................... 3 8

LAST PAGE= PAGE 38


PART I INTRODUCTION

SECTION 1 GENERAL

Holtec International's Quality Assurance Manual (QAM) is the top-level policy documentthat establishes the quality assurance program and policy and assigns major functionalresponsibilities for activities conducted by or for Holtec for the areas identified in Table1.1. The QAM describes the methods and establishes quality assurance and administrativecontrol requirements that meet the applicable Codes and Standards identified in Table 1.2.

The Quality Assurance Program (QAP) is defined by the Holtec QAM that describes the QAelements, along with the associated implementing documents. Procedures and instructionsthat control Holtec's activities related to quality are required to be developed prior tocommencement of those activities. Policies establish high-level responsibilities andauthority for carrying out important administrative functions which are outside the scopeof the QAP. Procedures establish practices for certain activities which are common to allHoltec organizations performing those activities so that the activity is controlled andcarried out in a manner that meets QAP requirements. Procedures specific to a site,organization, or group establish detailed implementation requirements and methods, andmay be used to implement policies or be unique to particular functions or work activities.

This Topical Report provides a summary of the requirements set forth within Holtec's QAProgram related to design and testing activities for Small Module Reactor certification.

1.1 Scope/Applicability

This Topical Report contains programmatic requirements that mirror and amplify theprovisions of 10CFR50 Appendix B for applicable criteria related to design and testingactivities. The Topical Report has been specifically established to serve as the primaryvehicle to describe Holtec's QAP for the control of all safety significant activities carried outby the Company for activities listed in Table 1.1 and under the rules of the Codes andStandards identified in Table 1.2 under a seamless quality regimen.

Each of the programmatic commitments in this manual are elaborated as actionableinstructions in implementing procedures called Holtec Quality Procedures (HQPs) andother supporting procedures and instructions.

Safety-related SSCs, under the control of the QAP, are identified by design documents. Thetechnical aspects of these items are considered when determining program applicability,including, as appropriate, the item's design safety function. The QAP may be applied tocertain activities where regulations other than those specified in Table 1.2 establish QArequirements for activities within their scope.

The policy of Holtec is to assure a high degree of availability and reliability of the nuclearplant(s) and supporting equipment while ensuring the health and safety of all nuclearworkers and the general public. To this end, selected elements of the QAM are also appliedto certain activities that are not safety-related, but support safe, economic, and reliableplant operations, or where other NRC guidance establishes quality assurancerequirements. Implementing documents establish program element applicability.

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The definitions provided in ASME NQA-1-2008 and NQA-la-2009 Addenda, Part I, Section400, apply to select terms as used in this document.

Table 1.1: QA Program Applicability

Equipment/Items Primary Activities

Small Module Reactors Design and Testing to Support Certification

Table 1.2: QA Program Applicability

(The QAP complies with the following Codes and Standards)

Code of Federal Regulations Miscellaneous Codes and Standards

10CFR21, 10CFR50 Appendix B, 10CFR52 ASME NQA-1-2008 and NQA-la-2009Addenda, Parts I and II, with specificreference to selected Part III sections, asidentified in this document.

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PART II QAP DETAILS

SECTION 1 ORGANIZATION

1.1 General

This section describes the Holtec organizational structure, functional responsibilities, levelsof authority and interfaces for establishing, executing, and verifying QAP implementation.The overall organizational structure includes corporate, management and support staff,including interface responsibilities for multiple organizations that perform quality-relatedfunctions. Management gives careful consideration to the timing, extent, and effects oforganizational structure changes.

Holtec is comprised of numerous Divisions, all of whom may support the Company throughthe provisions of the QAP. Depending on the scope of a particular activity, one or more ofthese Divisions may be involved. The organizational structure of each Division is identifiedin a Holtec Quality Procedure (HQP) along with primary responsibilities of key personnel.

The Vice President of Quality is responsible to size the Quality Assurance staffcommensurate with the duties and responsibilities assigned.

The persons and organizations performing quality assurance functions shall have sufficientauthority and organizational freedom to identify quality problems; to initiate, recommend,or provide solutions; and to verify implementation of solutions. Regardless of theorganizational structure, the person(s) assigned the responsibility for assuring effectiveexecution of any portion of the QAP, at any location where activities subject to the QAP arebeing performed, shall have direct access to the levels of management necessary to performthe required functions without hindrance.

Quality Assurance personnel have the authority, and the responsibility, to stop work inprogress which is not being done in accordance with approved procedures or where safety orSSC integrity may be jeopardized. This authority extends to off-site work performed bysuppliers that furnish safety-related services to Holtec.

Figure 1.1 provides the Holtec organizational structure.

1.2 Organizational Responsibilities of Key Personnel

The following sections describe the reporting relationships, functional responsibilities, andauthorities for key upper management and quality personnel in the Holtec organization.

1.2.1 President

The President of Holtec is responsible for all aspects of design, licensing and relatedactivities. The President is also responsible for all technical and administrative supportactivities provided by Holtec and its contractors. The President directs the Executive VicePresident, Vice President of Engineering and Vice President of Operations in fulfillment oftheir responsibilities.

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1.2.2 Executive Vice President (EVP)

The Executive Vice President reports directly to the Holtec President. The EVP has overallresponsibility for ensuring that all project activities are carried out in accordance with theCompany's QAP. The EVP ensures that the Company's corporate culture promotes freeairing of views, vigorous implementation of the company's quality program, and aretribution-free work environment.

1.2.3 Vice President of Engineering (VPE)

The Vice President of Engineering (VPE) reports directly to the EVP. The VPE hasresponsibility for assuring that design and analysis work is performed in accordance withthe QAP and that personnel in these areas are appropriately trained and qualified toperform their scope of work.

1.2.4 Vice President of Operations (VPO)

The Vice President of Operations (VPO) reports directly to the EVP. The VPO has overallresponsibility for projects and project management.

1.2.5 Vice President of Quality (VPQ)

The Vice President of Quality (VPQ) reports directly to the President of Holtec. The VPQhas overall responsibility for the operation and implementation of the Holtec QAP. TheVPQ assures that the QA organization is of a size commensurate with its duties andresponsibilities.

1.2.6 Corporate Quality Assurance Manager and Quality Managers

The Corporate Quality Assurance Manager reports directly to the Vice President ofQuality. The Corporate Quality Assurance Manager is responsible for maintaining andupdating the QA Manual and supporting Holtec Quality Procedures, evaluatingcompliance to QAP requirements, and managing Quality Assurance Organizationresources. The Corporate Quality Assurance Manager is responsible for assuringcompliance with regulatory requirements and procedures through audits and technicalreviews; monitoring organizational processes to ensure conformance to commitmentsand licensing document requirements; and ensuring that vendors providing qualityservices to Holtec are meeting the requirements of applicable Codes and Standardsthrough vendor audits.

Division Quality Managers report directly to the Corporate Quality AssuranceManager. Division Quality Managers are responsible for the day to dayimplementation of the QAP at the applicable Holtec Division.

The Corporate Quality Assurance Manager and the Division Quality Managers areresponsible for assuring that appropriate QA training and qualification activities arecompleted as applicable to personnel performing quality related activities.

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The Corporate Quality Assurance Manager and the Division Quality Managers havesufficient independence from other Holtec priorities to bring forward issues affecting safetyand quality and make judgments regarding quality in all areas regarding Holtec activitiesas appropriate. If the Division Quality Manager disagrees with any actions taken by theproject management and is unable to obtain resolution, the Division Quality Manager shallinform the Corporate Quality Assurance Manager and bring the matter to the attention ofthe VPQ, who will determine the final disposition.

1.3 Quality Assurance Organizational Independence

Independence shall be maintained between the organization(s) performing the checking(quality assurance and control) functions and the organizations performing the functions.This provision is not applicable to design review/verification nor in certain applications whereindividuals within a specific organization did not perform the specific work and areappropriately qualified.

1.4 NQA-1 Commitment

In establishing its organizational structure, Holtec commits to compliance with NQA-1-2008, Requirement 1.

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Holtec Document HI-2 135649-NP

FIGURE 1.1: HOLTEC ORGANIZATIONAL STRUCTURELEGEND

Primary Reporting

Direct Line of ...............Communication

Executive/Senior/International VicePresidents (EVP)

Corporate QualityAssurance Manager

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SECTION 2 QUALITY ASSURANCE PROGRAM

Holtec has established the necessary measures and governing procedures to implement theQAP as described in the QAM. Holtec is committed to implementing the QAP in all aspectsof work that are important to safety as described and to the extent delineated in the QAM.The QAP includes monitoring activities against acceptance criteria in a manner sufficientto provide assurance that the activities important to safety are performed satisfactorily.Further, Holtec ensures through the systematic process described herein that its suppliersof safety-related services meet the applicable requirements of 10CFR50 Appendix B exceptwhere Holtec performs commercial grade dedication or implements applicable portions ofits own QAP on the supplier. Senior management is regularly apprised of the adequacy ofimplementation of the QAP through the audit functions described in Part II, Section 18.

The objective of the QAP is to assure that Holtec's processes as delineated in Table 1.1 arein accordance with governing regulations and license requirements. The program is basedon the requirements set forth in the Codes and Standards identified in Table 1.2 of thisdocument and as further described in the QAM. The QAP applies to those quality-relatedactivities that involve the functions of safety-related structures, systems, and components(SSCs) associated with the processes identified in Table 1.1. Cost and scheduling challengesmust be addressed; however, they do not prevent proper implementation of the QAP.

As described in Part III of the QAM, specific program controls are applied to nonsafety-related SSCs that are significant contributors to plant safety, for which the Codes listed inTable 1.1 are not applicable. The specific program controls, consistent with applicablesections of the QAM, are applied to those items in a select manner, targeted at thosecharacteristics or critical attributes that qualifies SSC as a significant contributor to plantsafety.

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

In general, the program requirements specified herein are detailed in implementingprocedures that are either Holtec 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 performed ona 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 resetforward. 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.

2.1 Responsibilities

Personnel who work directly or indirectly for Holtec are responsible for achieving

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acceptable quality in the work covered by the QAP. This includes the activities delineatedin Part I, Section 1.1. Holtec personnel performing verification activities are responsible forverifying the achievement of acceptable quality. Activities governed by the QAP areperformed as directed by documented instructions, procedures, and drawings that are of adetail appropriate for the activity's complexity and effect on safety. Instructions, proceduresand drawings specify quantitative or qualitative acceptance criteria as applicable orappropriate for the activity, and verification is against these criteria. Provisions areestablished to designate or identify the proper documents to be used in an activity, and toascertain that such documents are being used. The Project Manager in conjunction with theQuality Manager are responsible to verify that processes and procedures comply with theQAM and other applicable requirements, that such processes or procedures areimplemented, and that management appropriately ensures compliance.

2.2 Delegation of Work

Holtec retains and exercises the responsibility for the scope and implementation of aneffective QAP. Positions identified in Part II, Section 1, and corresponding Holtecprocedures may delegate all or part of the activities of planning, establishing, andimplementing the program for which they are responsible to others, but retain theresponsibility for the program's effectiveness. Decisions affecting safety are made at theappropriate level based upon their nature and effect, with technical advice or review asappropriate.

2.3 Site-Specific Safety-Related Design Basis Activities

Site-specific safety-related design basis activities are defined as those activities, includingsampling, testing, data collection, and supporting engineering calculations and reports, thatwill be used to determine the bounding physical parameters of the site. Appropriate qualityassurance measures are applied to these activities.

2.4 Periodic Review of the Quality Assurance Program

Management of those organizations implementing the QA program, or portions thereof,shall assess the adequacy of that part of the program for which they are responsible toassure its effective implementation at least once each year or at least once during the life ofthe activity, whichever is shorter. In this case, the activity is understood to be a generalprocess such as design.

2.5 Issuance and Revision to Quality Assurance Program

Administrative control of the QAP will be in accordance with 10 CFR 50.55(f). Changes tothe QAP are evaluated by the Corporate QA Manager to ensure that such changes do notdegrade safety for previously approved quality assurance controls specified in the QAP.New revisions to the QAP documents (Topical Report, QAM, HQPs) will be reviewed, at aminimum, by the Vice President of Quality and approved by the President.

2.6 Personnel Training and QualificationsPersonnel assigned to implement elements of the QAP shall be capable of performing theirassigned tasks. To this end, Holtec establishes and maintains formal indoctrination,training, and qualification as necessary for personnel performing, verifying, or managingactivities within the scope of the QAP to achieve initial proficiency, maintain proficiency,

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and adapt to technology changes, method, or job responsibilities. The indoctrination,training, and qualification programs are commensurate with scope, complexity, andimportance of the activities; and include or address the following, as appropriate:

Education, experience, and proficiency of the personnel receiving trainingGeneral criteria, technical objectives, requirements of applicable codes andstandards, regulatory commitments, company procedures, and quality assuranceprogram requirementsOn-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 applicable Holtecprocedures. Indoctrination includes, as appropriate, the administrative and technicalobjectives, requirements of the applicable codes and standards, and the QAM elements tobe employed. Records of personnel training and qualification are maintained.

The minimum qualifications of the Corporate Quality Assurance Manager are a)engineering or related science degree plus three years of quality assurance related work; ora high school diploma plus seven years of quality assurance related work; or 10 years ofquality assurance related work; and b) knowledge of applicable Codes and Standards.Special requirements shall include management and supervisory skins and experience ortraining in leadership, interpersonal communication, management responsibilities,motivation of personnel, problem analysis and decision making, and administrative policiesand procedures. Individuals who do not possess these formal education and minimumexperience requirements will not be eliminated automatically when other factors providesufficient demonstration of their abilities. These other factors are evaluated on a case-by-case basis and approved and documented by senior management.

The minimum qualifications for the individuals responsible for supervising QA or QCpersonnel is that each has a high school diploma or equivalent and has a minimum of oneyear of experience performing quality verification activities. Individuals who do not possessthese formal education and experience requirements will not be eliminated automaticallywhen other factors provide sufficient demonstration of their abilities. These other factorsare evaluated on a case-by-case basis and approved and documented by seniormanagement.

The minimum qualifications of individuals that are part of the Quality EngineeringDepartment responsible for planning, implementing, and maintaining the programs for theQAM are that each has a high school diploma or equivalent and a minimum of one year ofrelated work experience. Individuals who do not possess these formal education andminimum experience requirements will not be eliminated automatically when other factorsprovide sufficient demonstration of their abilities. These other factors are evaluated on acase-by-case basis and approved and documented by senior management.

2.7 NQA-1 Conunitment / Exceptions

In establishing qualification and training programs, Holtec commits to compliance withNQA-1-2008 Requirement 2 with the following clarifications and exceptions:

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Section 400 (a) (8) requires the date of certification expiration be included on thequalification record. Holtec considers the certification expiration date to be the datefrom the certification or recertification date plus the certification interval time andits inclusion on the qualification record is optional.

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SECTION 3 DESIGN CONTROL

Holtec has established and implements a process to control the design and design changesof items that are subject to the provisions of the QAP. The design process includesprovisions to control design inputs, outputs, changes, interfaces, records, andorganizational interfaces within Holtec and with suppliers. These provisions assure thatdesign inputs (such as design bases and the performance, regulatory, quality, and qualityverification requirements) are correctly translated into design outputs (such as analyses,specifications, drawings, procedures, and instructions) so that the final design outputcontains or references appropriate acceptance criteria that can be related to the designinput in sufficient detail to permit verification by inspection and test, as required. Designchange processes and the division of responsibilities for design-related activities aredetailed in Holtec and supplier procedures. Changes to design inputs and final designs arejustified and subject to design control measures commensurate with those applied to theoriginal design. The design control program includes interface controls necessary to controlthe development, verification, approval, release, status, distribution, and revision of designinputs and outputs. Design changes are reviewed and approved by the Holtec designorganization or by other organizations so authorized by Holtec as appropriate.

Design documents are reviewed by individuals knowledgeable in the QAP to ensure thedocuments contain the necessary QAP requirements.

3.1 Design Verification

Holtec: design processes provide for design verification to ensure that computer programsand activities subject to the provisions of the QAF are suitable for their intendedapplication, consistent with their effect on safety. Design changes are subjected to thesecontrols, which include verification measures commensurate with those applied to theoriginal 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 did notspecify a singular design approach, rule out certain design considerations, and did notestablish the design inputs used in the design, or if the supervisor is the only individual inthe organization competent to perform the verification. If the verification is performed bythe originator's supervisor, the justification of the need is documented and approved inadvance by management.

The extent of the design verification required is a function of the importance to safety of theitem or computer program under consideration, the complexity of the design, the degree ofstandardization, the state-of-the-art, and the similarity with previously proven designs. Thisincludes design inputs, design outputs, and design changes. Design verification proceduresare established and implemented to assure that an appropriate verification method is used,the appropriate design parameters to be verified are chosen, the acceptance criteria areidentified, and the verification is satisfactorily accomplished and documented. Verificationmethods may include, but are not limited to, design reviews, alternative calculations, andqualification testing. Testing used to verify the acceptability of a specific design feature

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demonstrates acceptable performance under conditions that simulate the most adversedesign conditions expected for the item's intended use.

Holtec normally completes design verification activities before the design outputs are usedby other organizations for design work, and before they are used to support other activitiessuch as procurement, manufacturing, or construction. When such timing cannot beachieved, the design verification is completed before relying on the item to perform itsintended design or safety function.

3.2 Design Records

Holtec maintains records sufficient to provide evidence that the design was properlyaccomplished. These records include the final design output and any revisions thereto, aswell as record of the important design steps (e.g., calculations, assumptions, analyses andcomputer programs) and the sources of input that support the final output. Design recordsshall be sufficiently detailed such that a technically qualified individual in the subject areacan review and understand the analysis and verify the adequacy of the results withoutrecourse to the analysis preparer.Design drawings reflect the properly reviewed and approved configuration of the plant or

equipment.

3.3 Computer Application and Digital Equipment Software

The QAP governs the development, procurement, testing, maintenance, control, and use ofcomputer applications 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 software configurationmanagement process. Holtec and suppliers are responsible for developing, approving, andissuing procedures, as necessary, to control the use of such computer application and digitalequipment software. The procedures require that the application software be assigned aproper quality classification and that the associated quality requirements be consistentwith this classification. Each application software and revision thereto is documented andapproved by the assigned Computer Code Expert. The QAP is also applicable to theadministrative functions associated with the maintenance and security of computerhardware where such functions are considered essential in order to comply with other QAPrequirements such as QA records.

3.4 Setpoint Control

Consistent with its role as the reactor designer and its responsibility to ensure that thesafety significant systems are operated in the safest possible manner, the instrument andequipment setpoints that could affect nuclear safety shall be established by HoltecInternational. To ensure clarity, setpoints shall be controlled in accordance with writteninstructions. As a minimum, these written instructions shall:

" Identify responsibilities and processes for reviewing, approving, and revisingsetpoints and setpoint changes defined by Holtec.

* Ensure that setpoints and setpoint changes are consistent with design and accidentanalysis requirements and assumptions.

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3.5 NQA-1 Comnitment

In establishing its program for design control and verification, Holtec commits to compliancewith NQA-1-2008 and NQA-la-2009 Addenda, Requirement 3. In addition, Holtec commitsto NQA-1 Subpart 2.7 for computer software and NQA-1 Subpart 2.14 for Quality Assurancerequirements for commercial grade items and services.

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SECTION 4 PROCUREMENT DOCUMENT CONTROL

Holtec has established the necessary measures and governing procedures to assure thatpurchased computer programs, items and services are subject to appropriate quality andtechnical requirements. Procurement document changes shall be subject to the same degreeof control as utilized in the preparation of the original documents. These controls includeprovisions such that:

Applicable technical, regulatory, administrative, quality, and reportingrequirements (such as specifications, codes, standards, and 10 CFR 21) are invokedfor procurement of computer programs, items and services. 10 CFR 21 requirementsfor posting, evaluating, and reporting will be followed and imposed on supplierswhen applicable. Applicable design bases and other requirements necessary toassure adequate quality shall be included or referenced in documents forprocurement of items and services. To the extent necessary and with the exceptionof items/services that are dedicated, procurement documents shall require suppliersto have a documented QA program that is determined to meet the applicablerequirements of 10 CFR 50, Appendix B, as appropriate to the circumstances ofprocurements (or the supplier may work under Holtec's approved QA program).

Reviews of procurement documents shall be performed by personnel who have access topertinent information and who have an adequate understanding of the requirements andintent of the procurement documents.

4.1 NQA-1 Commitment / Exceptions

In establishing controls for procurement, Holtec commits to compliance with NQA-1-2008Requirement 4, with the following clarifications and exceptions:

" With regard to services performed by a supplier, Holtec procurement documents mayallow the supplier to work under the Holtec QAP, including implementingprocedures, in lieu of the supplier having its own QAP.

" Section 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. Holtec may satisfy thisrequirement through the review of the procurement specification, when thespecification contains the technical and quality assurance requirements of theprocurement.

* Procurement documents for Commercial Grade Items that will be procured byHoltec for use as safety-related items shall contain technical and qualityrequirements as applicable, such that the procured item can be appropriatelydedicated in accordance with the Holtec QAM, Section 7, "Control of PurchasedMaterial, Equipment and Services."

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SECTION 5 INSTRUCTIONS, PROCEDURES, AND DRAWINGS

Holtec has established the necessary measures and governing procedures to ensure thatactivities affecting quality are prescribed by and performed in accordance with instructions,procedures, or drawings of a type appropriate to the circumstances and which, whereapplicable, include quantitative or qualitative acceptance criteria to implement the QAP.Such documents are prepared and controlled according to Part II, Section 6. In addition,means are provided to disseminate to the staff, instructions of both general and continuingapplicability, as well as those of short-term applicability. Provisions are included forreviewing, updating, and canceling such procedures.

5.1 Procedure Adherence

Holtec's policy is that procedures are followed, and the requirements for use of procedureshave been established in administrative procedures. Where procedures cannot be followedas written, provisions are established for making changes in accordance with Part II,Section 6. Requirements are established to identify the manner in which procedures are tobe implemented, including identification of those tasks that require: (1) the writtenprocedure to be present and followed step-by-step while the task is being performed, (2)verification of completion of significant steps, by initials or signatures or use of check-offlists as appropriate. Procedures that are required to be present and referred to directly arethose developed for extensive or complex jobs where reliance on memory cannot be trusted,tasks that are infrequently performed, and tasks where steps must be performed in aspecified sequence.

5.2 Procedure Content

The established measures address the applicable content of procedures as described inthe Introduction to Part II of NQA-1-2008 and NQA-la-2009 Addenda. In addition,procedures governing tests and inspections will include as applicable, initial conditionsand prerequisites for the performance of the activity.

5.3 NQA-1 Conmnitment

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

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SECTION 6 DOCUMENT CONTROL

Holtec has established the necessary measures and governing procedures to control thepreparation, issuance, and revision of documents that specify quality requirements orprescribe how activities affecting quality, including organizational interfaces, are conductedto ensure that correct documents are employed. The following controls, including electronicsystems used to make documents available, are applied to documents and changes thereto:

" Identification of controlled documents" Specified distribution of controlled documents for use at the appropriate location" A method to identify the correct document (including revision) to be used and control

of superseded documents" Identification of individuals responsible for controlled document preparation, review,

approval, and distribution" Review of controlled documents for adequacy, completeness, and approval prior to

distribution

* A method to ensure the correct documents are being used* A method to provide feedback from users to improve procedures and work

instructions

* Coordinating and controlling interface documents and procedures

The types of documents to be controlled include, but are not limited to:

* Drawings such as design, construction, installation, and as-built drawings" 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

6.1 Review and Approval of Documents

Documents are reviewed by qualified and knowledgeable persons other than the preparerfor adequacy and to ensure quality assurance measures have been appropriately applied.Procedures for design are also reviewed by the Quality Department to ensure qualityassurance measures have been appropriately applied. The documented review signifiesconcurrence.

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Prior to issuance or use, documents including revisions thereto, are approved by thedesignated authority. A listing of all controlled documents identifying the current approvedrevision, or date, is maintained so personnel can readily determine the appropriatedocument for use.

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 the originalreview and approval or by a designated organization that is appropriately qualified andknowledgeable. The reviewing organization has access to pertinent background data orinformation upon which to base their approval. Minor changes to documents, such asinconsequential editorial corrections, do not require that the revised documents receive thesame review and approval as the original documents. To avoid a possible omission of arequired review, the type of minor changes that do not require such a review and approvaland the persons who can authorize such a classification shall be clearly delineated inimplementing procedures.


In establishing provisions for document control, Holtec commits to compliance with NQA-1-2008, Requirement 6.

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SECTION 7 CONTROL OF PURCHASED MATERIAL, EQUIPMENT, ANDSERVICES

Holtec has established the necessary measures and governing procedures to controlpurchased items and services to assure conformance with specified requirements. Suchcontrol provides for the following as appropriate: source evaluation and selection, evaluationof objective evidence of quality furnished by the supplier, source inspection, audit, andexamination of items or services.

7.1 Acceptance of Item or Service

Holtec establishes and implements measures to assess the quality of purchased items andservices, whether purchased directly or through contractors, at intervals and to a depthconsistent with the item or service importance to safety, complexity, quantity, and thefrequency of procurement. Verification actions may include testing, as appropriate, duringdesign activities. Verifications occur at the appropriate phases of the procurement process,and may include, as necessary, verification of activities of suppliers below the first tier.

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

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

" Prospective safety-related items and service suppliers are evaluated to assure onlyqualified suppliers are used. Qualified safety related suppliers are audited on atriennial basis. If required work is outside the scope that the supplier is currentlyqualified for based on the audit, a supplemental audit may be performed in order toincrease the scope of the supplier's qualification.

" Holtec may utilize audits conducted by outside organizations for supplierqualification provided that the scope and adequacy of the audits meet Holtecrequirements. Documented annual evaluations are performed for qualified safetyrelated suppliers to assure they continue to provide acceptable products and services.The results of the reviews are promptly considered for effect on a supplier'scontinued qualification and adjustments made as necessary (including correctiveactions, adjustments of supplier audit plans, and input to third party auditingentities, as warranted). In addition, results are reviewed periodically to determine if,as a whole, they constitute a significant condition adverse to quality requiringadditional action.

" Provisions are made for accepting purchased items and services, such as sourceverification, receipt inspection, pre and post-installation tests, certificates ofconformance, and document reviews (including Certified Material TestReport/Certificate). Acceptance actions/documents should be established by Holtecwith appropriate input from the supplier and be completed in order to assure theadequacy and compliance of the supplied items or services before relying on the itemto perform its intended safety 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-related applications.

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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 to beprovided. The initial audit is performed after the supplier has completed sufficientwork to demonstrate that its organization is implementing a QA program.


In establishing controls for purchased items and services, Holtec commits to compliancewith NQA-1-2008 and NQA-la-2009, Requirement 7, with the following clarifications andexceptions:

Holtec considers that other 10 CFR Parts 50 and 52 licensees, Authorized NuclearInspection Agencies, National Institute of Standards and Technology, or other Stateand Federal agencies which may provide items or services to Holtec are not requiredto be evaluated or audited.

* When purchasing commercial grade calibration services from a calibrationlaboratory, procurement source evaluation and selection measures need not beperformed provided each of the following conditions are met:

- The purchase documents impose any additional technical and administrativerequirements, as necessary, to comply with the Holtec QA program and technicalprovisions. At a minimum, the purchase document shall require that thecalibration certificate/report include identification of the laboratoryequipment/standard used.

- The purchase documents require reporting as-found calibration data whencalibrated items are found to be out-of-tolerance.

- A documented review (via placement on the approved vendor list) of thesupplier's accreditation will be performed and will include a verification of thefollowing:

" The calibration laboratory holds a domestic (United States) accreditation byan NRC-approved accrediting body recognized by the InternationalLaboratory Accreditation Cooperation (ILAC) Mutual RecognitionArrangement (MRA).The accreditation encompasses ANS/ISO/IEC 17025,"General Requirements for the Competence of Testing and CalibrationLaboratories." The following accrediting bodies apply:

- NVLAP, A2LA, L-A-B, ACLASS, IAS

o The published scope of accreditation for the calibration laboratory covers thenecessary measurement parameters, range, and uncertainties.

* For Section 501, Holtec considers documents that may be stored in approvedelectronic media under Holtec or vendor control to comply with the intendedrequirement.

" In establishing commercial grade item requirements, Holtec commits to compliancewith NQA-la-2009, Section 700 and Subpart 2.14, with the following clarification:

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For commercial grade items, quality verification requirements are establishedand described in Holtec documents to provide the necessary assurance an itemwill perform satisfactorily in service. The Holtec documents address, asapplicable, determining the critical characteristics that ensure an item issuitable for its intended use, technical evaluation of the item, receiptrequirements, and quality evaluation of the item.

Holtec will assume 10 CFR 21 reporting responsibility for all items that Holtecdedicates as safety related.

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SECTION 8 IDENTIFICATION AND CONTROL OF MATERIALS, PARTS,AND COMPONENTS

As this Topical Report is for design and testing activities related to the certification ofSmall Module Reactors, this section is generally not applicable except where testing tosupport design is warranted and as appropriate.

Holtec has established the necessary measures and governing procedures to identify andcontrol items to prevent the use of incorrect or defective items.


In establishing provisions for identification and control of items, Holtec commits tocompliance with NQA-1-2008, Requirement 8 as applicable for test activities related todesign qualification.

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SECTION 9 CONTROL OF SPECIAL PROCESSES

This Topical Report addresses design and testing activities to support certification of aSmall Module Reactor. As such, this criteria is not applicable.

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SECTION 10 INSPECTION


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SECTION 11 TEST CONTROL

Holtec has established the necessary measures and governing procedures to demonstratethat items subject to the provisions of the QAP will perform satisfactorily in service. Testprograms include criteria for determining when testing is required in order to demonstratethat performance of equipment and plant systems is in accordance with design. Testingprograms also include provisions to establish and adjust test schedules, and to maintainstatus for periodic or recurring tests when applicable. Tests are performed according toapplicable procedures that include, as applicable and consistent with the effect on safety:(1) instructions and prerequisites to perform the tests, (2) use of proper test equipment, (3)acceptance criteria, (4) mandatory verification points as necessary to confirm satisfactorytest completion, (5) any special qualification requirements for personnel and (6) anyspecial environmental conditions. Test results are documented and evaluated by theorganization performing the tests. Test records are traceable to the item(s) tested. Ifacceptance criteria are not met, re-testing is performed as needed to confirm acceptabilityfollowing correction of the system or equipment deficiencies that caused the failure.

Except for computer program testing, which is addressed in Section 11.1, tests areperformed and results documented in accordance with applicable technical and regulatoryrequirements, including those described in the Technical Specifications and SAR. Testprograms ensure appropriate retention of test data in accordance with the recordsrequirements of the QAP. Personnel that perform or evaluate tests are qualified inaccordance with the requirements established in Part II, Section 2, as applicable.

11.1 NQA-1 Commitment for Computer Program Testing

Holtec establishes and implements provisions to assure that computer software used inapplications affecting safety is prepared, documented, verified and tested, and used suchthat the expected output is obtained and configuration control maintained. To this endHoltec commits to compliance with the requirements of NQA-la-2009, Requirement 11 andSubpart 2.7 to establish the appropriate provisions in addition to the commitment to NQA-1-2008, Requirement 3.


In establishing provisions for testing, Holtec commits to compliance with NQA-la-2009,Requirement 11.

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SECTION 12 CONTROL OF MEASURING AND TEST EQUIPMENT

This section is applicable to testing activities necessary to support the design of a SmallModule Reactor.

Holtec has established the necessary measures and governing procedures to control thecalibration, maintenance, and use of measuring and test equipment (M&TE) that providesdata to verify acceptance criteria are met. Procedures also address requirements for out ofcalibration conditions. The provisions of such procedures cover equipment such asindicating and actuating instruments and gauges, tools, reference and transfer standards,and nondestructive examination equipment. Appropriate documentation will be maintainedfor these devices to indicate the control status, when the next calibration is due, andidentify any limitations on use of the device. The suppliers of commercial-grade calibrationservices are controlled as described in Part II, Section 7.

M&TE are calibrated at prescribed intervals, or prior to use, against certified equipmenthaving known valid relationships to nationally recognized standards. If no nationallyrecognized standards exist, the bases for calibration is documented.


In establishing provisions for control of measuring and test equipment, Holtec commits tocompliance with NQA-1-2008, Requirement 12.

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SECTION 13 HANDLING, STORAGE, AND SHIPPING


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SECTION 14 INSPECTION, TEST, AND OPERATING STATUS


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SECTION 15 NONCONFORMING MATERIALS, PARTS, ORCOMPONENTS


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SECTION 16 CORRECTIVE ACTION

Holtec has established the necessary measures and governing procedures to promptlyidentify, control, document, classify, and correct conditions adverse to quality. Holtecprocedures assure that corrective actions are documented and initiated following thedetermination of conditions adverse to quality in accordance with regulatory requirementsand applicable quality standards. Holtec procedures require personnel to identify knownconditions adverse to quality. When complex issues arise where it cannot be readilydetermined if a condition adverse to quality exists, Holtec documents establish therequirements for documentation and timely evaluation of the issue. Reports of conditionsadverse to quality are analyzed to identify trends. Significant conditions adverse to qualityand significant adverse trends are documented and reported to responsible management. Inthe case of a significant condition adverse to quality, the cause is determined and actions topreclude recurrence are taken.

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

16.1 Interface with the Reporting Program

Holtec has appropriate interfaces between the QAP for corrective actions and the non-QAReporting Program to satisfy the requirements of the applicable Codes and Standards listedin Table 1.2.


In establishing provisions for corrective action, Holtec commits to compliance with NQA-1-2008, Requirement 16.

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SECTION 17 QUALITY ASSURANCE RECORDS

Holtec has the necessary measures and governing procedures to ensure that sufficientrecords of items and activities affecting quality are developed, reviewed, approved, issued,used, and revised to reflect completed work. The provisions of such procedures establish thescope of the records retention program for Holtec and include requirements for recordsadministration, including receipt, preservation, retention, storage, safekeeping, retrieval,access controls, user privileges and final disposition.

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, test, audits and other applicable quality records and theirretention times are defined in appropriate procedures. The records and retention times arebased on Regulatory Position C.1.a(3) of Regulatory Guide 1.28, Revision 4. In all caseswhere state, local, or other agencies have more restrictive requirements for recordretention, those requirements will be met.

17.2 Electronic Records

When using optical disks for electronic records storage and retrieval systems, Holtec shallcomply with the NRC guidance in Generic Letter 88-18, "Plant Record Storage on OpticalDisks." Holtec will manage the storage of QA Records in electronic media in accordance withapplicable Holtec procedures which shall meet the intent of RIS 2000-18 and associatedNIRMA Guidelines TG 11-1998, TG15-1998, TG16-1998, and TG21-1998 with the followingexception:

TG- 11 Section 6.4.3 states that, "New tapes should be exercised for a minimum of four fullpasses prior to use for archive record recording." Modern premium data storage tapes aremade specifically for archival purpose, and therefore have higher quality control and faulttolerance than tapes from the time that this standard was originally written. As such,Holtec does not perform tape exercising.

17.3 NQA-1 Commnitment / Exceptions

In establishing provisions for records, Holtec commits to compliance with NQA- 1-2008,Requirement 17, and regulatory positions stated in Regulatory Guide 1.28, Rev 4,dated June, 2010.

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SECTION 18 AUDITS

Holtec has established the necessary measures and governing procedures to implementaudits to verify that activities covered by the QAP are performed in conformance with theestablished requirements and performance criteria are met. The audit programs arethemselves reviewed for effectiveness as a part of the overall audit process.

18.1 Performance of Audits

Internal audits of the implementation of Holtec's QAP are performed with a frequencycommensurate with safety significance. Internal audits are performed to verify complianceand effectiveness of implementation of programs and procedures using a representativesample. Internal audits also provide a means to verify that processes and programs aremeaningful and comply with the overall QAP.

Internal audits of selected aspects of the new plant licensing and design activities areperformed with a frequency commensurate with safety significance and in a manner whichassures that audits of the applicable safety-related activities are completed. Functionalareas of an organization's QA program for auditing include, at a minimum, verification ofcompliance and effectiveness of implementation of internal rules, procedures (e.g., design,procurement, surveillance, test), regulations, programs for training, retraining, andpersonnel qualification and corrective actions, including associated record keeping.

The audits are scheduled on a formal preplanned audit schedule and in a manner toprovide coverage and coordination with ongoing activities, based on the status andimportance of the activity and to assure that each applicable element of Holtec's QAP isaudited at least once each year. Additional audits may be performed as deemed necessaryby management. The scope of the audit is determined by the quality status and safetyimportance of the activities being performed. These audits are conducted by trainedpersonnel not having direct responsibilities in the area being audited and in accordancewith preplanned and approved audit plans or checklists, under the direction of a qualifiedlead auditor and the cognizance of the Corporate Quality Assurance Manager.

The results of each internal audit are captured in an audit report and are reported inwriting to the President of Holtec. Additional internal distribution is made to otherconcerned management levels and to management of the internal audited organizations oractivities in accordance with approved procedures.

Management responds to all audit findings and initiates corrective action where indicated.Where corrective action measures are indicated, documented follow-up of applicable areasthrough inspections, review, re-audits, or other appropriate means is conducted as deemedwarranted to verify implementation of assigned corrective action.

Audits of suppliers of safety-related items and/or services are conducted as described inSection 7.1. Audits of suppliers are conducted to verify the adequacy of the supplier's QAProgram.

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In establishing the independent audit program, Holtec commits to compliance with NQA-1-2008, Requirement 18.

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PART III NONSAFETY-RELATED SSC QUALITY CONTROL

SECTION 1 NONSAFETY-RELATED SSCS - SIGNIFICANTCONTRIBUTORS TO PLANT SAFETY

Specific program controls are applied to nonsafety-related SSCs, for which 10 CFR 50,Appendix B is not applicable, that are significant contributors to plant safety. The specificprogram controls are applied to those items in a selected manner, targeted at thosecharacteristics or critical attributes that render the SSC a significant contributor to plantsafety.

The following clarify the applicability of the QA Program to the nonsafety-related SSCs andrelated activities for those items and activities considered to be significant contributors toplant safety.

1.1 Organization

The organizational structure as defined in Part II, Section 1 still applies thoughspecific responsibilities defined in Part II may not apply.

1.2 QA Program

Holtec QA requirements for nonsafety-related SSCs are established in thissection of the QAM. A separate QAM is not required.

1.3 Design Control

Holtec has design control measures to ensure that the contractually establisheddesign requirements are included in the design. These measures ensure thatapplicable design inputs are included or correctly translated into the designdocuments, and deviations from those requirements are controlled. Designverification is provided through the normal supervisory review of the designer'swork.

1.4 Procurement Document Control

Procurement documents for items and services obtained by or for Holtec includeor reference documents describing applicable design bases, design requirements,and other requirements as applicable and as necessary to ensure componentperformance. The procurement documents are controlled to address deviationsfrom the specified requirements.

1.5 Instructions, Procedures, and Drawings

Holtec provides documents such as, but not limited to, written instructions anddrawings to direct the performance of activities affecting quality. The method ofinstruction employed provides an appropriate degree of guidance to the personnelperforming the activity to achieve acceptable performance.

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1.6 Document Control

Holtec controls the issuance and change of documents that specify qualityrequirements or prescribe activities affecting quality to ensure that correctdocuments are used. These controls include review and approval of documents,identification of the appropriate revision for use, and measures to preclude theuse of superseded or obsolete documents.

1.7 Control of Purchased Items and Services

Holtec employs measures, such as inspection of items or documents upon receiptto ensure that applicable purchased items and services conform to appropriateprocurement documents.

1.8 Identification and Control of Purchased Items

This Topical Report addresses design and testing activities to supportcertification of a Small Module Reactor. As such, this criteria is not applicable.

1.9 Control of Special Processes


1.10 Inspection


1.11 Test Control

Holtec employs measures to identify required testing to support design activities.These tests are performed in accordance with test instructions or procedures asappropriate.

1.12 Control of Measuring and Test Equipment (M&TE)

Holtec employs measures to control M&TE use, and calibration and adjustmentat specific intervals or prior to use.

1.13 Handling, Storage, and Shipping


1.14 Inspection, Test, and Operating Status


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1.15 Control of Nonconforming Items


1.16 Corrective Action

Holtec employs measures to ensure that conditions adverse to quality areproperly identified, reported, and corrected.

1.17 Records

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

1.18 Audits

If performed, audits are conducted and documented to verify compliancewith design and procurement documents, instructions, procedures, drawings,and test activities as appropriate. Where the measures of this part (Part III)are implemented by the same programs, processes, or procedures as thecomparable activities of Part II, the audits performed under the provisions ofPart II may be used to satisfy the review requirements of this Section (PartIII, Section 1.18).

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SECTION 2 NON-SAFETY-RELATED SSCS CREDITED FORREGULATORY EVENTS

The following criteria apply to the design and licensing aspects applicable to fire protection(10 CFR 50.48), anticipated transients without scram (ATWS) (10 CFR 50.62), and thestation blackout (SBO) (10 CFR 50.63) SSCs that are not safety-related;

" Holtec commits to implement quality requirements to the fire protection system inaccordance Regulatory Position 1.7, "Quality Assurance," in RG 1.189, Revision 2,October 2009; "Fire Protection for Operating Nuclear Power Plants."

" Holtec commits to implement the quality requirements for ATWS equipment inaccordance with Generic Letter 85-06, "Quality Assurance Guidance for ATWSEquipment That is Not Safety Related.".

* Holtec commits to implement quality requirements for SBO equipment inaccordance with Regulatory Position 3.5, "Quality Assurance and Specific Guidancefor SBO Equipment that is Not safety Related," and appendix A, "Quality AssuranceGuidance for Non-Safety Systems and Equipment," in RG 1.155,Revison 0, 1998;"Station Blackout".

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PART IV REGULATORY COMMITMENTS(Note: This Part only applies for design and licensing activities for anuclear plant under Holtec's own docket under the rules of 10 CFR 50 and52.)

NRC Regulatory Guides and Quality Assurance Standards

This section identifies the NRC Regulatory Guides (RG) and the other quality assurancestandards which have been selected to supplement and support the Holtec QAP. Holteccomplies with these standards to the extent described or referenced. Commitment to aparticular RG or standard does not constitute a commitment to other RGs or standards thatmay be referenced therein. See FSAR Chapter 1 for the Holtec evaluation of conformancewith the guidance in NRC Regulatory Guides in effect six months prior to the submittaldate of the application.

Regulatory Guides:

Regulatory Guide 1.26, (Revision 4, March 2007) - Quality Group Classifications andStandards for Water-, Steam-, and Radioactive-Waste-Containing Components of NuclearPower Plants

Regulatory Guide 1.26 defines classification of systems and components.

Holtec identifies conformance and exceptions for the applicable regulatory position guidanceprovided in this regulatory guide in FSAR Chapter 1 and/or 3.

Regulatory Guide 1.28, (Rev. 4, June 2010), Quality Assurance Program Criteria (Designand Construction)

Regulatory Guide 1.28 describes a method acceptable to the NRC staff for complying withthe provisions of Appendix B with regard to establishing and implementing the requisitequality assurance program for the design of nuclear power plants.

Holtec identifies conformance and exceptions for the applicable regulatory position guidanceprovided in this regulatory guide in FSAR Chapter 1.

Regulatory Guide 1.29, (Revision 4, March 2007) - Seismic Design Classification

Regulatory Guide 1.29 defines systems required to withstand a safe shutdown earthquake(SSE).

Holtec identifies conformance and exceptions for the applicable regulatory position guidanceprovided in this regulatory guide in FSAR Chapter 1.

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Standards:

ASME NQA-1-2008 Edition with NQA-la-2009 Addenda - Quality AssuranceRequirements for Nuclear Facility Applications

Holtec commits to NQA-1-2008 with NQA-la-2009 Addenda, Parts I and II, asdescribed in Part II of this document with specific identification of exceptions orclarification. Holtec commits to NQA-1-2008 with NQA-la-2009 Addenda, and Part IIIonly as specifically noted in Part II of this document.

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

Holtec commits to NIRMA TGs as described in Part II, Section 17.

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