pqd-hd-19005, rev 0, 'us-apwr topical report, quality ...for design certification of the...

US-APWR Topical Report

Quality Assurance Prowram Description

Doc. Number:PQD-HD-19005 ROMUAP-07002 ROMUAP-07003 RO

January 2007AMITSUBISHI HEAVY INDUSTRIES, LTD.

©2007Mitsubishi Heavy Industries, Ltd.

All Rights Reserved

Quality Assurance Program (QAP) DescriptionFor Design Certification of the US-APWR POD-HD-19005 Revision 0

Quality Assurance Program (QAP) DescripionFor Design Certification of the US-APWR

PQD-HD-19005

-Topical Report

Process/Program Owner:General Manager

of Nuclear Energy Systems Quality& Safety Management Department

Version Number Revision 0 -Effective Date o .

Prepared y/Date:"

N. Shimi , Manager, Nuclearjfnergy Systems Quality & Safety MYnagement Department

Reviewed By/Date:

N. Miykak-i, General Manager,. Nuclear Energy Systems Quality & Safety Management Department

Approved By/Date:

.Y.Ura i ecu Vuclear Energy Systems Headquarters

Mitsubishi Heavy Industries, LTD. \

Quality Assurance Program (QAP) DescriptionFor Design Certification of the US-APWR PQD-HD-19005 Revision 0 0

Revision History

Revision Page Description

0 All Original issued

Mitsubishi Heavy Industries, LTD.

Quality Assurance Program (QAP) DescriptionFor Design Certification of the US-APWR PQD-HD-19005 Revision 0

POLICY STATEMENT

Nuclear Energy Systems Headquarters in Mitsubishi Heavy Industries, Ltd. (MHI-NESH) shalldesign and procure nuclear plants in a manner that will ensure the health and safety of thepublic and workers. These activities shall be performed in compliance with the requirements ofthe U.S. Code of Federal Regulations (CFR) and applicable laws and regulations of the stateand local governments.

The MHI-NESH US-APWR Project Quality Assurance Program is the Quality AssuranceProgram (QAP) provided in this document and the associated implementing documents.Together they provide for control of MHI-NESH activities that affect the quality of safety relatednuclear plant structures, systems, and components and include all planned and systematicactivities necessary to provide adequate confidence that such structures, systems, andcomponents will perform satisfactorily in service. The QAP may also be applied to certainequipment and activities that are not safety-related, but support safe plant operations, orwhere other NRC guidance establishes program requirements.

The QAP is the top-level policy document that establishes the manner in which quality is to beachievedand presents MHI-NESH's overall philosophy regarding achievement and assuranceof quality. Implementing documents assign more detailed responsibilities and requirementsand define the organizational interfaces involved in conducting activities within the scope ofthe Quality Assurance Program.

Compliance with the QAP and irniplementing documents is mandatory for personnel directly orindirectly associated with implementation of the MHI-NESH Quality Assurance Program.

n ' Y.Uratani

Executive Vice PresidentNuclear Energy Systems Headquarters

Mitsubishi Heavy Industries, Ltd.

, Mitsubishi Heavy Industries, LTD.ii

Quality Assurance Program (QAP) DescriptionFor Design Certification of the US-APWR PQD-HD-1 9005 Revision 0

TABLE OF CONTENTS

POLICY STATEMENT......................................................................iPART I INTRODUCTION .................................................................... 1

SECTION 1 GENERAL ........................................................................... 11.1 Scope/ Applicability ........................................................................ 1

PART 11 QAIP DETAILS .................................................................... 2SECTION I ORGANIZATION.................................................................... 2

1. 1 Executive Vice President ................................................................... 21.2 APWR Promoting Department ............................................................. 21.3 Nuclear Energy Systems Engineering Center............................................. 21.4 Nuclear Energy Systems Quality and Safety Management Department................ 31.5 Authority to Stop Work...................................................................... 41.6 NQA-1-1994 Commitment .................................................................. 4Figure 11.1-1....................................................................................... 5Figure 11.1-2....................................................................................... 6

SECTION 2 QUALITY ASSURANCE PROGRAM ............................................. 72.1 Responsibilities ............................................................................. 72.2 Delegation of Work .......................................................................... 82.3 Periodic Review of the Quality Assurance Program...................................... 82.4 Issuance and Revision to Quality Assurance Program................................... 82.5 Personnel Qualifications.................................................................... 92.6 Legacy Issue................................................................................ 92.7 NQA-1 -1994 Commitment / Exceptions ................................................... 9

SECTION 3 DESIGN CONTROL................................................................. 113.1 Design Verification.......................................................................... 113.2 Design Records.............................................................................. 123.3 Computer Application and Digital Equipment Software .................................. 123.4 NQA-1-1994 Commitment .................................................................. 12

SECTION 4 PROCUREMENT DOCUMENT CONTROL....................................... 134.1 NQA-1 -1994 Commitment .................................................................. 13

SECTION 5 INSTRUCTIONS, PROCEDURES, AND DRAWINGS........................... 155.1 Procedure Adherence ...................................................................... 155.2 Procedure Content.......................................................................... 155.3 NQA-1-1994 Commitment .................................................................. 15

SECTION 6 DOCUMENT CONTROL ........................................................... 166.1 Review and Approval of Documents ...................................................... 166.2 Changes to Documents ..................................................................... 166.3 NQA-1 -1 994 Commitment .................................................................. 17

SECTION 7 CONTROL OF PURCHASED MATERIAL, EQUIPMENT, AND SERVICES. 187.1 Acceptance of Item or Service............................................................. 187.2 NQA-1-1994 Commitment .................................................................. 19

SECTION 8 IDENTIFICATION AND CONTROL OF MATERIALS, PARTS, ANDCOMPONENTS ..................................................................... 20

SECTION 9 CONTROL OF SPECIAL PROCESSES .......................................... 21SECTION 10 INSPECTION....................................................................... 22

10. 1 NQA-1 -1994 Commitment................................................................. 23

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SECTION 11 TEST CONTROL .......................................................................................... 2411.1 NQA-1-1994 Commitment ..................................................................................... 2411.2 NQA-1-1994 Commitment for Computer Program Testing .................................... 24

SECTION 12 CONTROL OF MEASURING AND TEST EQUIPMENT ............................ 2512.1 NQA-1-1994 Commitment / Exceptions ............................................................... 25

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

15.1 R eporting Program ................................................................................................ 2815.2 NQA-1 -1994 Commitment ..................................................................................... 28

SECTION 16 CORRECTIVE ACTION ............................................................................. 2916.1 R eporting Program ............................................................................................... 2916.2 NQA-1-1994 Commitment ..................................................................................... 29

SECTION 17 QUALITY ASSURANCE RECORDS ......................................................... 3017.1 R ecord R etention .................................................................................................. 3017.2 Electronic R ecords ................................................................................................ 3017.3 NQA-1-1994 Commitment/ Exceptions .............................................................. 30

S EC T IO N 18 A U D ITS ...................................................................................................... 3118.1 Perform ance of A udits ............................................................................................ 3118.2 NQA-1 -1994 Commitment ..................................................................................... 32

PART III REGULATORY TREATMENT OF NON-SAFETY SYSTEMS .................. 33PART IV REGULATORY COMMITMENTS ............................................................. 37

NRC Regulatory Guides and Quality Assurance Standards ....................................... 37R egulato ry G uides: ...................................................................................................... .. 37S ta n d a rd s : .......................................................................................................................... 3 7

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PART I INTRODUCTION

SECTION 1 GENERAL

The MHI-NESH US-APWR Project Quality Assurance Program (QAP) is the top-level policydocument that establishes the quality assurance policy and assigns major functionalresponsibilities for plants designed by MHI-NESH. The QAP describes the methods andestablishes QAP and administrative control requirements that meet 10 CFR 50, Appendix B.The QAP is based on the requirements of ASME NQA-1-1994, "Quality AssuranceRequirements for Nuclear Facility Applications," Parts I and II, as specified in this document.

The QAP is defined by the NRC approved regulatory document that describes the QualityAssurance Program elements, along with the associated implementing documents.Procedures and instructions that control US-APWR Project activities are developed prior tocommencement of activities. (See section 2.6 of Part II for additional information)Business policies of MHI-NESH establish high level responsibilities and authority for carryingout administrative functions which are outside the scope of the QAP.

Procedures establish practices for certain activities which are common to all MHI-NESHorganizations performing those activities such that the activity is controlled and carried out in amanner that meets QAP requirements. Organization specific procedures establish detailedimplementation requirements and methods, and may be used to implement the businesspolicies of MHI-NESH or be unique to particular functions or work activities.

1.1 Scope I Applicability

This QAP applies to activities affecting the quality and performance of safety-related structures,systems, and components, including, but not limited to:

Designing Testing Licensing ProcuringInspecting

Safety-related systems, structures, and components, under the control of the QAP, areidentified by design documents. The technical aspects of these items are considered whendetermining program applicability, including, as appropriate, the item's design safety function.The QAP may be applied to certain activities where regulations other than 10 CFR 50establish QAP requirements for activities within their scope.

The policy of MHI-NESH is to assure a high degree of availability and reliability of its nuclearplants while ensuring the health and safety of its workers and the public. To this end, selectedelements of the QAP are also applied to certain equipment and activities that are not safety-related, but support safe, economic, and reliable plant operations, or where other NRCguidance establishes quality assurance requirements. Implementing documents establishprogram element applicability.

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PART II QAP DETAILS

SECTION 1 ORGANIZATION

This Section describes the MHI-NESH organizational structure, functional responsibilities,levels of authority and interfaces for establishing, executing, and verifying QAP implementation.The organizational structure includes corporate and design functions for the development ofthe US-APWR. Implementing documents assign more specific responsibilities and duties, anddefine the organizational interfaces involved in conducting activities and duties within thescope of this QAPD. Management gives careful consideration to the timing, extent and effectsof organizational structure changes.

The MHI-NESH US-APWR Project organization is responsible for US-APWR plant licensing,engineering, procurement and development activities. There are several organizations withinMHI-NESH which implement and support the QAP.

The following sections describe the reporting relationships, functional responsibilities andauthorities for organizations implementing and supporting the US-APWR Project QA Program.The MHI-NESH organization and the US-APWR Project organization are shown in Figures11.1-1 and 11.1-2 respectively.

1.1 Executive Vice President

The Executive Vice President of MHI-NESH is responsible for all aspects of design of MHI-NESH's nuclear plants. The Executive Vice President is also responsible for all technical andadministrative support activities provided by MHI-NESH. The Executive Vice President directsthe General Manager of Nuclear Energy Systems Engineering, the General Manager of APWRPromoting Department and General Manager of Nuclear Energy Systems Quality & SafetyManagement Department in fulfillment of their responsibilities. The Executive Vice Presidentreports to the President of Mitsubishi Heavy Industries, Ltd. with respect to all matters.

1.2 APWR Promoting Department (APPD)

US-APWR Project in MHI-NESH organization is responsible for US-APWR plant licensing,engineering and procurement activities.

1.2.1 General Manager of APPD (APPD Manager)

The APPD Manager reports to the Executive Vice President and is responsible for theadministration of the US-APWR QAP. The APPD Manager also directs the planning anddevelopment of the APPD staff, and organization resources.

1.3 Nuclear Energy Systems Engineering Center (N-Center)

The N-Center organization is responsible for engineering and licensing.

1.3.1 General Manager of N-Center (N-Center Manager)



The N-Center Manager reports to the Executive Vice President and is responsible for theadministration of engineering and nuclear fuel under the QAP. As shown in Figure 11.1-2, for

the US-APWR, the General Manager of N-Center takes project direction from the GeneralManager of APPD.

1.3.2 General Manager of Reactor Core Engineering Department (RCE Manager)

The RCE Manager reports to the N-Center Manager and is responsible for the engineering ofBasic Design of Fuel & Core under the QAP.

1.3.3 General Manager of Reactor Safety Engineering Department (RSE Manager)

The RSE Manager reports to the N-Center Manager and is responsible for the engineering ofSafety Analysis under the QAP.

1.3.4 General Manager of Water Reactor Engineering Department (WRE Manager)

The WRE Manager reports to the N-Center Manager and is responsible for the engineering ofBasic Design of System, I&C and Plant under the QAP.

1.3.5 Group Manager of Planning & Administration Group (P&A-G Manager)

The P&A-G Manager reports to theN-Center Manager and is responsible for theadministration of engineering and general affairs for N-Center under the QAP.

1.4 Nuclear Energy Systems Quality and Safety Management Department (NESQD)

The MHI-NESH Quality Assurance Organization is responsible for independently planning andperforming activities to verify the development and effective implementation of the MHI-NESHQAPs including but not limited to US-APWR Project, engineering, licensing, document control,corrective action program and procurement that support new nuclear plant generation.

1.4.1 General Manager of NESQD (NESQD Manager)

The NESQD Manager reports to the Executive Vice President for the design activities and isresponsible for developing and maintaining the MHI-NESH QAP, evaluating compliance to theprogram and managing the QA organization resources.

Also the NESQD Manager is responsible for the development and verification ofimplementation of the QAP described in this document. The NESQD Manager is responsiblefor assuring compliance with regulatory requirements and procedures through audits andtechnical reviews; for monitoring organization processes to ensure conformance tocommitments and licensing document requirements; for ensuring that vendors providingquality services to MHI-NESH are meeting the requirements of 10 CFR 50, Appendix Bthrough MHI-NESH vendor audits. The NESQD Manager has sufficient independence fromother US-APWR Project priorities to bring forward issues affecting safety and quality andmakes judgments regarding quality in all areas necessary regarding MHI-NESH US-APWRProject activities. The NESQD Manager may make recommendations to the US-APWR Projectmanagement regarding improving the quality of work processes. If the NESQD Manager



disagrees with any actions taken by the US-APWR Project organization and is unable toobtain resolution, the NESQD Manager shall refer the matter to the Executive Vice Presidentwho will determine the final disposition.

1.5 Authority to Stop Work

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 extends to work performed by suppliers furnishingsafety-related services to MHI-NESH.

1.6 NQA-1-1994 Commitment

In establishing its organizational structure, MHI-NESH commits to compliance with NQA-1-1994, Basic Requirement 1 and Supplement 1S-1.


Quality Assurance Program (QAP) DescriptionFor Design Certification of the US-APWR PQD-HD-19005 Revision 0 0

Figure 11.1-1

MHI-NESH Organization

Executive Vice PresidentMHI-NESH

L I

General ManagerAPWR Promoting

Department(APPD)

General ManagerNuclear Energy Systems

Engineering Center(N-Center)


Quality & SafetyManagement Department

(NESQD)

i0

General ManagerReactor CoreEngineeringDepartment

General ManagerReactor Safety

EngineeringDepartment

General ManagerWater Reactor

EngineeringDepartment

Group ManagerPlanning &

Administration Group



Figure 11.1-2

US-APWR Project Organization

Executive Vice PresidentMHI-NESH

General ManagerAPWR Promoting

Department(APPD)


Quality & SafetyManagement Department

(NESQD)


Engineering Center(N-Center)

Department



SECTION 2 QUALITY ASSURANCE PROGRAM

MHI-NESH has established the necessary measures and governing procedures to implementthe QAP as described in the QAP. MHI-NESH is committed to implementing the QualityAssurance Program in all aspects of work that are important to the safety of the nuclear plantsas described and to the extent delineated in this QAP. Further, MHI-NESH ensures through thesystematic process described herein that its suppliers of safety-related equipment or servicesmeet the applicable requirements of 10 CFR 50, Appendix B. This QAP also applies to certainnonsafety-related structures, systems, components and activities to a degree consistent withtheir importance to safety. Senior management is regularly apprised of audit results evaluatingthe adequacy of implementation of the QAP through the audit functions described in the AuditSection of this QAP.

The objective of the QAP is to assure that MHI-NESH nuclear generating plants are designedconstructed and operated in accordance with governing regulations and license requirements.The program is based on the requirements of ASME NQA-1-1994, "Quality AssuranceRequirements for Nuclear Facility Applications," as further described in this document. TheQAP applies to those quality-related activities that involve the functions of safety-relatedstructures, systems, and components (SSCs) associated with the design, licensing,construction and operation of new nuclear power plants. A list identifying SSCs and activitiesto which this program applies is maintained at the appropriate facility. Regulatory Guide 1.26 isused as a basis for this list. Cost and scheduling functions do not prevent properimplementation of the QAP.

Specific program controls are applied to non-safety related SSCs, for which 1 OCFR50,Appendix B is not applicable, that are significant contributors to plant safety. The specificprogram controls consistent with applicable sections of the QAP are applied to those items in aselected manner, targeted at those characteristics or critical attributes that render the SSC asignificant contributor to plant safety.

Delegated responsibilities may be performed under a supplier's or principal contractor's QAP,provided that the supplier or principle contractor has been approved as a supplier inaccordance with the QAP. Periodic audits and assessments of supplier QA programs areperformed to assure compliance with the supplier's or principle contractor's QAP andimplementing procedures. In addition, routine interfaces with project personnel assure thatquality expectations are met.

A grace period of 25% may be applied to the provisions that are required to be performed on aperiodic basis unless otherwise noted. Annual evaluations and audits that must be performedon a triennial basis are examples where the 25% grace period will be applied.

2.1 Responsibilities

Personnel who work directly or indirectly for MHI-NESH are responsible for the achievement ofacceptable quality in the work covered by this QAP. This includes those activities delineated inPart I, Section 1.1 of this QAP. MHI-NESH personnel performing verification activities areresponsible for verifying the achievement of acceptable quality. Activities governed by theQAP are performed as directed by documented instructions, procedures and drawings that areof a detail appropriate for the activity's complexity and effect on safety. Instructions,



procedures and drawings specify quantitative or qualitative acceptance criteria as applicableor appropriate 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 NESQD Manager is responsible to verifythat processes and procedures comply with QAP and other applicable requirements, that suchprocesses or procedures are implemented, and that management appropriately ensurescompliance.

2.2 Delegation of Work

MHI-NESH retains and exercises the responsibility for the scope and implementation of aneffective QAP. Positions identified in the Organization Section of this QAP may delegate all orpart of the activities of planning, establishing, and implementing the program for which theyare responsible to others, but retain the responsibility for the program's effectiveness.Decisions affecting safety are made at the level appropriate for its nature and effect, and withany necessary technical advice or review.

2.3 Periodic Review of the Quality Assurance Program

Reviews of the status and adequacy of the US-APWR Project QA program and itsimplementation will be conducted on an ongoing basis via senior management review ofquality assurance audit reports.

2.4 Issuance and Revision to Quality Assurance Program

Administrative control of the QAP during design certification will be in accordance with 10 CFR50.55(f), as appropriate. Changes to the QAP are evaluated by the Engineer of NESQD toensure that such changes do not degrade previously approved quality assurance controlsspecified in the QAP. This document shall be revised as appropriate to incorporate additionalQA commitments. New revisions to the document will be reviewed, at a minimum, by theSenior Engineer of NESQD and approved by the NESQD Manager.

Changes to QAP will be submitted for review as specified in § 50.4.The submittal of a change to the quality assurance program description will include all pagesaffected by that change and will be accompanied by a forwarding letter identifying the change,the reason for the change, and the bases for concluding that the revised programincorporating the change continues to satisfy the criteria of Appendix B of 1OCFR50 and thequality assurance program description commitments previously accepted by the NRC.

A copy of the forwarding letter identifying the changes will be maintained as a facility record forthree years.

Changes to the quality assurance program description will be regarded as accepted by theCommission upon receipt of a letter to this effect from the appropriate reviewing office of theCommission or 60 days after submittal to the Commission, whichever occurs first.



2.5 Personnel Qualifications

Personnel assigned to implement elements of the QAP shall be capable of performing theirassigned tasks. To this end MHI-NESH establishes and maintains formal indoctrination andtraining programs for personnel performing, verifying, or managing activities within the scopeof the QAP to assure that suitable proficiency is achieved and maintained. Sufficientmanagerial depth is provided to cover absences of incumbents. When required by code,regulation, or standard, specific qualification and selection of personnel is conducted inaccordance with those requirements as established in the applicable MHI-NESH procedures.Indoctrination includes the administrative and technical objectives, requirements of theapplicable codes and standards, and the QAP elements to be employed. Records of personneltraining and qualification are maintained.

The minimum qualifications of the Engineer of NESQD and the Engineer of APPD are thateach holds an engineering or related science degree and has a minimum of four years ofrelated experience (3 of the 4 years must include 2 years of nuclear power plant experience)and 1 year of supervisory or management experience and one year of experience performingquality verification activities. Individuals who do not possess these formal education andminimum experience requirements should not be eliminated automatically when other factorsprovide sufficient demonstration of their abilities. These other factors are evaluated on acases-by-case basis and approved and documented by senior management.

2.6 Legacy Issue

The US-APWR design is based on the design of the Japanese-APWR. The J-APWR designwas completed in accordance with a prior version of MHI's QA program, which was based onJapanese Guidelines. The requirements of the Japanese Guidelines have been compared tothe QA requirements of 10CFR50, Appendix B, ASME NQA-1-1994 and Standard ReviewPlan 17.5 and were found to be very similar. Certain test activities completed under researchand development relied on alternative controls allowed by the Japanese Guidelines, but notaddressed in the U.S. requirements. These test activities are evaluated in accordance with aprocedure to provide reasonable assurance that the completed design work satisfies 1 OCFR50,Appendix B.

2.7 NQA-1 -1994 Commitment / Exceptions

In establishing qualification and training programs, MHI-NESH commits to compliancewith NQA-1 -1994, Basic Requirement 2 and Supplements 2S-1, 2S-3 and 2S-4, with thefollowing clarifications and exceptions:

" NQA-1-1994, Supplement 2S-1

- MHI commits to require suppliers to establish and perform inspection and testpersonnel qualification in accordance with NQA-1-1994 and Supplement 2S-1.

" NQA-1-1994, Supplement 2S-2

- This Supplement is not applicable at this time (DC application).

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NQA-1-1994, Supplement 2S-3

- The requirement that prospective Lead Auditors have participated in a minimumof five (5) audits in the previous three (3) years is replaced by the following,"The prospective lead auditor shall demonstrate his/her ability to properlyimplement the audit process, as implemented by MHI-NESH, to effectivelylead an audit team, and to effectively organize and report results, includingparticipation in at least one nuclear audit within the year preceding the date ofqualification."



SECTION 3 DESIGN CONTROL

MHI-NESH has established and implements a process to control the design and designchanges of items that are subject to the provisions of this QAP. The design process includesprovisions to control design inputs, outputs, changes, interfaces, records and organizationalinterfaces within MHI-NESH and with suppliers. These provisions assure that design inputs(such as design bases and the performance, regulatory, quality, and quality verificationrequirements) are correctly translated into design outputs (such as analyses, specifications,drawings, procedures, and instructions) so that the final design output can be related to thedesign input in sufficient detail to permit verification. Design change processes and the divisionof responsibilities for design-related activities are detailed in MHI-NESH and supplierprocedures. The design control program includes interface controls necessary to control thedevelopment, verification, approval, release, status, distribution and revision of design inputsand outputs.Design changes and disposition of nonconforming items as "use as is" or "repair" are reviewedand approved by the MHI-NESH design organization or by other organizations so authorizedby MHI-NESH.

Design documents are reviewed by individuals knowledgeable in QA to ensure the documentscontain the necessary QA requirements.

3.1 Design Verification

MHI-NESH design processes provide for design verification to ensure that items and activitiessubject to the provisions of this QAP are suitable for their intended application, consistent withtheir effect on safety. Design changes are subjected to these controls, which includeverification measures commensurate with those applied to original plant design.

Design verifications are performed by competent individuals or groups other than those whoperformed the original design but who may be from the same organization. The verifier shallnot have taken part in the selection of design inputs, the selection of design considerations, orthe selection of a singular design approach, as applicable. This verification may be performedby the originator's supervisor provided the supervisor did not specify a singular designapproach, rule out certain design considerations, and did not establish the design inputs usedin the design, or if the supervisor is the only individual in the organization competent toperform the verification. If the verification is performed by the originator's supervisor, thejustification of the need is documented and approved in advance by management.

The extent of the design verification required is a function of the importance to safety of theitem under consideration, the complexity of the design, the degree of standardization, thestate-of-the-art, and the similarity with previously proven designs. This includes design inputs,design outputs and design changes. Design verification procedures are established andimplemented to assure that an appropriate verification method is used, the appropriate designparameters to be verified are chosen, the acceptance criteria are identified, and the verificationis satisfactorily accomplished and documented. Verification methods may include, but are notlimited to, design reviews, alternative calculations and qualification testing. Testing used toverify the acceptability of a specific design feature demonstrates acceptable performanceunder conditions that simulate the most adverse design conditions expected for item'sintended use.



MHI-NESH 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, manufacture or construction. When such timing cannot beachieved, the design verification is completed before relying on the item to perform itsintended design or safety function.

If existing qualification test results are proposed for use in the US-APWR design, test resultswill be re-evaluated using the procedure described in section 2.6 above.

3.2 Design Records

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

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

3.3 Computer Application and Digital Equipment Software

The QAP shall govern the development, procurement, testing, maintenance, and use ofcomputer application and digital equipment software when used in safety-related applicationsand designated nonsafety-related applications. MHI-NESH and suppliers shall be responsiblefor developing, approving, and issuing procedures, as necessary, to control the use of suchcomputer application and digital equipment software. The procedures shall require that theapplication software be assigned a proper quality classification and that the associated qualityrequirements be consistent with this classification. Each application software and revisionthereto shall be documented and approved by authorized personnel. This QAP shall also beapplicable to the administrative functions associated with the maintenance and security ofcomputer hardware where such functions are considered essential in order to comply withother QAP requirements such as QA records.


In establishing its program for design control and verification, MHI-NESH commits tocompliance with NQA-1 -1994, Basic Requirement 3, and Supplement 3S-1 and the standardsfor computer software contained in Subpart 2.7.



SECTION 4 PROCUREMENT DOCUMENT CONTROL

MHI-NESH has established the necessary measures and governing procedures to assure thatpurchased items and services are subject to appropriate quality and technical requirements.Procurement document changes shall be subject to the same degree of control as utilized inthe preparation of the original documents. These controls include provisions such that:

" Where original technical or quality assurance requirements cannot be determined, anengineering evaluation is conducted and documented by qualified staff to establishappropriate requirements and controls to assure that interfaces, interchangeability,safety, fit and function, as applicable, are not adversely affected or contrary to applicableregulatory requirements.

" Applicable technical, regulatory, administrative, quality and reporting requirements (suchas specifications, codes, standards, tests, inspections, special processes, and 10 CFR21) are invoked for procurement of items and services. 10 CFR 21 requirements forposting, evaluating and reporting will be followed and imposed on suppliers whenapplicable. Applicable design bases and other requirements necessary to assureadequate quality shall be included or referenced in documents for procurement of itemsand services. To the extent necessary, procurement documents shall require suppliers tohave a documented QA program that is determined to meet the applicable requirementsof 10 CFR 50, Appendix B, as appropriate to the circumstances of procurements (or thesupplier may work under MHI's 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 and intentof the procurement documents.


In establishing controls for procurement, MHI-NESH commits to compliance with NQA-1-1994,Basic Requirement 4 and Supplement 4S-1, with the following clarifications and exceptions:

- NQA-1-1994, Supplement 4S-1

- Section 2.3 of this Supplement 4S-1 includes a requirement that procurementdocuments require suppliers to have a documented QAP that implements NQA-1-1994, Part 1. In lieu of this requirement, MHI-NESH may require suppliers tohave a documented supplier QAP that is determined to meet the applicablerequirements of 10 CFR 50, Appendix B, as appropriate to the circumstances ofthe procurement.

- With regard to service performed by a supplier, MHI-NESH procurementdocuments may allow the supplier to work under the MHI-NESH QA program,including implementing procedures, in lieu of the supplier having its own QAprogram.



- Section 3 of this supplement 4S-1 requires procurement documents to bereviewed prior to bid or award of contract. The quality assurance review ofprocurement documents is satisfied through review of the applicableprocurement specification, including the technical and quality procurementrequirements, prior to bid or award of contract.

- Procurement documents for Commercial Grade Items that will be dedicated byMHI-NESH as safety-related items shall contain technical and qualityrequirements such that the procured item can be appropriately dedicated.



SECTION 5 INSTRUCTIONS, PROCEDURES, AND DRAWINGS

MHI-NESH 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 asdescribed in the QAP. Such documents are prepared and controlled according to Part II,Section 6 of this QAP. In addition, means are provided for dissemination to the staff ofinstructions of both general and continuing applicability, as well as those of short-termapplicability. Provisions are included for reviewing, updating, and canceling such procedures.

5.1 Procedure Adherence

The MHI-NESH policy is that procedures are followed, and the requirements for use ofprocedures have been established in administrative procedures. Where procedures cannot befollowed as written, provisions are established for making changes in accordance with Part II,Section 6 of this QAP. Requirements are established to identify the manner in whichprocedures are to be implemented, including identification of those tasks that require(1) the written procedure to be present and followed step-by-step while the task is being

performed,(2) the user to have committed the procedure steps to memory,(3) 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 developed forextensive or complex jobs where reliance on memory cannot be trusted, tasks that areinfrequently performed, and tasks where steps must be performed in a specified sequence.

5.2 Procedure Content

The established measures address the applicable content of procedures as described in theintroduction to Part II of NQA-1-1994. In addition, procedures governing tests and inspectionswill include as applicable, initial conditions and prerequisites for the performance of the activity.


In establishing procedural controls, MHI-NESH commits to compliance with NQA-1-1994,Basic Requirement 5.



SECTION 6 DOCUMENT CONTROL

MHI-NESH has established the necessary measures and governing procedures to control thepreparation of, issuance of, and changes to documents that specify quality requirements orprescribe how activities affecting quality, including organizational interfaces, are controlled toassure that correct documents are being employed. The control system (including electronicsystems used to make documents available) shall be documented and shall provide for (a)through (e) below:

(a) identification of documents to be controlled and their specified distribution;(b) a method to identify the correct document (including revision) to be used and control of

superseded documents;(c) Identification of assignment of responsibility for preparing, reviewing, approving, and

issuing documents;(d) review of documents for adequacy, completeness, and correctness prior to approval

and issuance.(e) a method for providing feedback from users to continually improve procedures and

work instructions.

The types of documents to be controlled include:(a) drawings such as design, construction, installation, and as-built drawings;(b) engineering calculations(c) design specifications(d) purchase orders and related documents(e) vendor-supplied documents(f) audit, surveillance, and quality verification/inspection procedures(g) inspection and test reports(h) instructions and procedures for activities covered by this QAP(i) nonconformance reports and corrective action reportsPersonnel from the QA organization review and concur with quality-related proceduresassociated with design.

6.1 Review and Approval of Documents

Documents shall be reviewed for adequacy by qualified persons other than the preparer.Prior to issuance or use, documents including revisions thereto, shall be approved by thedesignated authority. A listing of all controlled documents identifying the current approvedrevision, or date, is maintained so personnel can readily determine the appropriate documentfor use.

6.2 Changes to Documents

Changes to documents, other than those defined in implementing procedures as minorchanges, shall be reviewed and approved by the same organizations that performed theoriginal review and approval unless other organizations are specifically designated. Thereviewing organization shall have access to pertinent background data or information uponwhich to base their approval. Minor changes to documents, such as inconsequential editorialcorrections, do not require that the revised documents receive the same review and approvalas the original documents. To avoid a possible omission of a required review, the type of minor



changes that do not require such a review and approval and the persons who can authorize

such a classification shall be clearly delineated in implementing procedures.

6.3 NQA-1 -1994 Commitment

In establishing provisions for document control, MHI-NESH commits to compliance with NQA-1-1994, Basic Requirement 6 and Supplement 6S-1.



SECTION 7 CONTROL OF PURCHASED MATERIAL, EQUIPMENT, ANDSERVICES

MHI-NESH has established the necessary measures and governing procedures to control theprocurement of items and services to assure conformance with specified requirements. Suchcontrol shall provide for the following as appropriate: source evaluation and selection,evaluation of objective evidence of quality furnished by the supplier, source inspection, audit,and examination of items or services.

7.1 Acceptance of Item or Service

MHI-NESH establishes and implements measures to assess the quality of purchased itemsand services, whether purchased directly or through contractors, at intervals and to a depthconsistent with the item's or service's importance to safety, complexity, quantity and thefrequency of procurement. Verification actions include testing, as appropriate, during design,fabrication and construction activities. Verifications occur at the appropriate phases of theprocurement process, including, as necessary, verification of activities of suppliers below thefirst 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, ormisuse.

" Prospective suppliers of safety-related items and services are evaluated to assure thatonly qualified suppliers are used. Qualified suppliers are audited on a triennial basis.MHI-NESH may utilize audits conducted by outside organizations for supplierqualification provided that the scope and adequacy of the audits meet MHI-NESHrequirements. Documented annual evaluations are performed for qualified suppliers toassure they continue to provide acceptable products and services. Industry programs,such as those applied by ASME, Nuclear Procurement Issues Committee (NUPIC), orother established utility groups, are used as input or the basis for supplier qualificationwhenever appropriate. The results of the reviews are promptly considered for effect on asupplier's continued qualification and adjustments made as necessary (includingcorrective actions, adjustments of supplier audit plans, and input to third party auditingentities, as warranted). In addition, results are reviewed periodically to determine if, as awhole, they constitute a 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/documentsshould be established by the Purchaser with appropriate input from the Supplier and becompleted to ensure that procurement, inspection, and test requirements, as applicable,have been satisfied before relying on the item to 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-grade



services or items to assure they will perform satisfactorily in service in safety-related

applications.


In establishing procurement verification controls, MHI-NESH commits to compliance withNQA-1 -1994, Basic Requirement 7 and Supplement 7S-1, with the following clarifications andexceptions:

NQA-1-1994, Supplement 7S-1

- MHI-NESH considers that other 10 CFR 50 licensees, Authorized NuclearInspection Agencies, National Institute of Standards and Technology, or other Stateand Federal agencies which may provide items or services to MHI-NESH plants arenot required to 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:

(1) The purchase documents impose any additional technical and administrativerequirements, as necessary, to comply with the MHI-NESH QA program andtechnical provisions. At a minimum, the purchase document shall require thatthe calibration certificate/report include identification of the laboratoryequipment/standard used.

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

(3) A documented review of the supplier's accreditation shall be performed andshall include a verification of each of the following:

0 The calibration laboratory holds an accreditation by the NationalVoluntary Laboratory Accreditation Program (NVLAP) or by theAmerican Association for Laboratory Accreditation (A2LA) asrecognized by NVLAP through a Mutual Recognition Arrangement(MRA).

E The accreditation is based on ANS/ISO/IEC 17025.

E The published scope of accreditation for the calibration laboratorycovers the necessary measurement parameters, ranges, anduncertainties.

- For Section 8.1, MHI-NESH considers documents that may be stored in approvedelectronic media under MHI-NESH or vendor control and not physically located onthe plant site but which are accessible from the respective nuclear facility site asmeeting the NQA-1 requirement for documents to be available at the site.



SECTION 8 IDENTIFICATION AND CONTROL OF MATERIALS, PARTS, ANDCOMPONENTS

This section is not applicable at this time (DC application).



SECTION 9 CONTROL OF SPECIAL PROCESSES




SECTION 10 INSPECTION

MHI-NESH does not perform inspection activity in the DC stage. Suppliers will perform thisactivity. So MHI-NESH requires suppliers to perform following items.

Suppliers shall establish the necessary measures and governing procedures 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 activitiesaffecting plant reliability and integrity. Types of inspections may include those verificationsrelated to procurement, such as source, in-process, final, and receipt inspection. Inspectionsare carried out by properly qualified persons independent of those who performed or directlysupervised the work. Inspection results shall be documented.

Inspection Program

The inspection program establishes inspections (including surveillance of processes), asnecessary to verify quality:(1) at the source of supplied items or services,(2) in-process during fabrication at a Supplier's facility,(3) for final acceptance of fabricated and/or installed items,(4) upon receipt of items for a facility.

The inspection program establishes requirements for planning inspections, such as the groupor discipline responsible for performing the inspection, where inspection hold points are to beapplied, determining applicable acceptance criteria, the frequency of inspection to be applied,and identification of special tools needed to perform the inspection. Inspection planning isperformed by personnel qualified in the discipline related to the inspection and includequalified inspectors or engineers. Inspection plans are based on, as a minimum, theimportance of the item to the safety of the facility, the complexity of the item, technicalrequirements to be met, and design specifications. Where significant changes in inspectionactivities for the facilities are to occur, management responsible for the inspection programsevaluate the resource and planning requirements to ensure effective implementation of theinspection program.

Inspection program documents establish requirements for performing the planned inspections,and documenting required inspection information such as: reject, acceptance, andreinspection results; and the person(s) performing the inspection.

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.

Inspector Qualification

Suppliers of MHI-NESH shall establish qualification programs for personnel performing qualityinspections. The qualification program requirements are described in Section 2 of this QAP.These qualification programs are applied to individuals performing quality inspectionsregardless of the functional group where they are assigned.




- MHI-NESH commits to require suppliers to establish inspection requirements inaccordance with NQA- 1-1994, Basic Requirement 10 and Supplement 1OS-1.

Mitsubishi Heavy Industries, LTD. 023


SECTION 11 TEST CONTROL

MHI-NESH does not perform test activity except for under mentioned 11.2 in the DC stage.Suppliers will perform this activity. So MHI-NESH requires suppliers to perform following items.

Tests are performed according to applicable procedures that include, consistent with the effecton safety,(1) instructions and prerequisites to perform the test,(2) use of proper test equipment,(3) acceptance criteria, and(4) 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 been satisfied. Ifacceptance criteria are not met, retesting is performed as needed to confirm acceptabilityfollowing correction of the system or equipment deficiencies that caused the failure.

The tests are performed and results documented in accordance with applicable technical andregulatory requirements. The test programs ensure appropriate retention of test data inaccordance with the records requirements of this QAP. The personnel performing orevaluating tests are qualified in accordance with the requirements established in Section 2 ofthis QAP.Tests previously completed will be evaluated using the procedure described in section 2.6.


MHI-NESH commits to require suppliers to establish provisions for testing in accordance withNQA-1-1 994, Basic Requirement 11 and Supplement 11S-1.

11.2 NQA-1-1994 Commitment for Computer Program Testing

MHI-NESH establishes and implements provisions to assure that computer software used inapplications affecting safety is prepared, documented, verified and tested, and used such thatthe expected output is obtained and configuration control maintained. To this end MHI-NESHcommits to compliance with the requirements of NQA-1 -1994, Supplement 11 S-2 and Subpart2.7 to establish the appropriate provisions.



SECTION 12 CONTROL OF MEASURING AND TEST EQUIPMENT

MHI-NESH does not perform the control of measuring and test equipment in the DC stage.Suppliers will perform this activity. So MHI-NESH requires suppliers to perform the followingitems.

Suppliers shall establish the necessary measures and governing procedures to control thecalibration, maintenance, and use of measuring and test equipment (M&TE) that providesinformation important to safe plant operation. The provisions of such procedures coverequipment such as indicating and actuating instruments and gages, tools, reference andtransfer standards, and nondestructive examination equipment. Commercial-grade calibrationservices shall be controlled as described in Section 7 of this QAP.

12.1 NQA-1-1994 Commitment/ Exceptions

MHI-NESH commits to require suppliers to establish provisions for control of measuring andtest equipment, in accordance with NQA-1 -1994, Basic Requirement 12 and Supplement 12S-1:

- The out of calibration conditions described in paragraph 3.2 of Supplement 12S-1refers to when the M&TE is found out of the required accuracy limits (i.e. out oftolerance) during calibration.

Measuring and test equipment are not required to be marked with the calibrationstatus where it is impossible or impractical due to equipment size or configuration(such as the label will interfere with operation of the device) provided the requiredinformation is maintained in suitable documentation traceable to the device.



SECTION 13 HANDLING, STORAGE, AND SHIPPING




SECTION 14 INSPECTION, TEST, AND OPERATING STATUS




SECTION 15 NONCONFORMING MATERIALS, PARTS, OR COMPONENTS

MHI-NESH has established the necessary measures and governing procedures to controlitems, including services, which do not conform to specified requirements to preventinadvertent installation or use. Controls provide for identification, documentation, evaluation,segregation when practical, and disposition of nonconforming items, and for notification toaffected organizations. Controls are provided to address conditional release of nonconformingitems for use on an at risk basis prior to resolution and disposition of the nonconformance,including maintaining identification of the item and documenting the basis for such release.Conditional release of nonconforming items for installation requires the approval of thedesignated management. Nonconformances are corrected or resolved prior to depending onthe item to perform its intended safety function. Nonconformances are evaluated for impact onoperability of quality 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, shall be subject todesign 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 MHI-NESH procedures, regulatory requirements, andindustry standards.

15.1 Reporting Program

MHI-NESH will establish the necessary measures and governing procedures that implement areporting program which conforms to the requirements of 10 CFR 50.55(e) and/or 10 CFR 21during construction and 10 CFR 21 during operations.


In establishing measures for nonconforming materials, parts, or components, MHI-NESHcommits to compliance with NQA-1-1994, Basic Requirement 15, and Supplement 15S-1.



SECTION 16 CORRECTIVE ACTION

MHI-NESH has established the necessary measures and governing procedures to promptlyidentify, control, document, classify and correct conditions adverse to quality. MHI-NESHprocedures assure that corrective actions are documented and initiated following thedetermination of conditions adverse to quality in accordance with regulatory requirements andapplicable quality standards. MHI-NESH 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, MHI-NESH documents establish therequirements for documentation and timely evaluation of the issue.Reports of conditions adverse to quality are analyzed to identify trends. Significant conditionsadverse to quality and significant adverse trends are documented and reported to responsiblemanagement. In the case of a significant condition adverse to quality, the cause is determinedand actions to preclude recurrence are taken and the cause and corrective action are reportedto management.

In the case of suppliers working on safety-related activities, or other similar situations, thelicensee may delegate specific responsibilities of the Corrective Action program but thelicensee maintains responsibility for the program's effectiveness.

16.1 Reporting Program

MHI-NESH has in-place the necessary measures and governing procedures that implement aprogram to identify, evaluate and report defects and non-compliances in accordance with 10CFR 50.55(e) and/or 10 CFR Part 21, as applicable. Such a reporting program applies tosafety-related activities and services performed by MHI-NESH and/or MHI-NESH suppliers /sub-suppliers providing input to DC application development.

16.2 NQA-1 -1994 Commitment

In establishing provisions for corrective action, MHI-NESH commits to compliance with NQA-1-1994, Basic Requirement 16.



SECTION 17 QUALITY ASSURANCE RECORDS

MHI-NESH shall establish 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 such proceduresestablish the scope of the records retention program for MHI-NESH and include requirementsfor records administration, including receipt, preservation, retention, storage, safekeeping,retrieval, and final disposition.

17.1 Record Retention

Measures are required to be established that ensure that sufficient records of completed itemsand activities affecting quality are appropriately stored. Such records and their retention timesare defined in appropriate procedures. In all cases where state, local, or other agencies havemore restrictive requirements for record retention, those requirements will be met.

17.2 Electronic Records

When using electronic records storage and retrieval systems, MHI-NESH complies with NRCguidance Generic Letter 88-18, "Plant Record Storage on Optical Disks." MHI-NESH willmanage the storage of QA Records in electronic media consistent with the intent of RIS 2000-18 and associated NIRMA Guidelines TG 11-1998, TG15-1998, TG16-1998, and TG21-1998.

17.3 NQA-1 -1994 Commitment/ Exceptions

In establishing provisions for records, MHI-NESH commits to compliance with NQA-1-1994,Basic Requirement 17 and Supplement 17S-1, with the following clarifications and exceptions:

NQA-1-1 994, Supplement 17S-1

- Supplement 17S-1, section 4.2(b) requires records to be firmly attached in bindersor placed in folders or envelopes for storage in steel file cabinets or on shelving incontainers. For hard-copy records maintained by MHI-NESH, the records aresuitably stored in steel file cabinets or on shelving in containers, except thatmethods other than binders, folders or envelopes may be used to organize therecords for storage.



SECTION 18 AUDITS

MHI-NESH has established the necessary measures and governing procedures to implementaudits to verify that activities covered by this QAP are performed in conformance with therequirements established. The audit programs are themselves reviewed for effectiveness as apart of the overall audit process.

18.1 Performance of Audits

Internal audits of selected aspects of licensing, design phase are performed with a frequencycommensurate with safety significance and in a manner which assures that audits of safety-related activities are completed. During the early portions of US-APWR Project activities,audits will focus on areas including, but not limited to, procurement, and corrective action.Functional areas of an organization's QA program for auditing include at a minimumverification of compliance and effectiveness of implementation of internal rules, procedures(e.g., design, procurement, surveillance, test), regulations, programs for training, retraining,qualification and corrective actions associated record keeping. The audits are scheduled on aformal preplanned audit schedule. The audit system is reviewed periodically and revised asnecessary to assure coverage commensurate with current and planned activities. Additionalaudits may be performed as deemed necessary by management. The scope of the audit isdetermined by the quality status and safety importance of the activities being performed.These audits are conducted by trained personnel not having direct responsibilities in the areabeing audited and in accordance with preplanned and approved audit plans or checklists,under the direction of a qualified lead auditor and the cognizance of the NESQD Manager.

The MHI-NESH is responsible for conducting periodic internal and external audits. Internalaudits are conducted to determine the adequacy of programs and procedures (byrepresentative sampling), and to determine if they are meaningful and comply with the overallQAP. External audits determine the adequacy of supplier and contractor quality assuranceprogram.

The results of each audit are reported in writing to the responsible section manager, ordesignee, as appropriate. Additional internal distribution is made to other concernedmanagement levels 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 to verifyimplementation of assigned corrective action.

Internal Audits

a. 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 once each yearor 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 this QAP; regulations; provisions fortraining, retraining, qualification, and performance of personnel performing activities covered



by this QAP; corrective actions taken following abnormal occurrences; and, observation of the

performance of activities including associated record keeping.

b. Audits of suppliers of safety-related components are conducted as described in Section 7.1.


In establishing the independent audit program, MHI-NESH commits to compliance with NQA-1-1994, Basic Requirement 18 and Supplement 18S-1.



PART III REGULATORY TREATMENT OF NON-SAFETY SYSTEMS(RTNSS)

Specific program controls are applied to non-safety related SSCs, 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 QAP are applied to those items in aselected manner, targeted at those characteristics or critical attributes that render the SSC asignificant contributor to plant safety.

The following clarify the applicability of the QA Program to the RTNSS SSCs and relatedactivities, including the identification of exceptions to the QA Program described in Part II,Sections 1 through 18 taken for RTNSS SSCs.

Section 1 Organization

The verification activities described in this part may be performed by the MHI-NESH lineorganization, the QA organization described in Part II is not required to perform thesefunctions.

Section 2 QA Program

MHI-NESH QA requirements for RTNSS are contained in this QAP and appropriateprocedures. Suppliers of these SSCs or related services may describe the quality controlsapplied in appropriate procedures, a new or separate QA program is not required.

Section 3 Design Control

MHI-NESH shall establish design control measures to ensure that the contractuallyestablished design requirements are included in the design. These measures ensure thatapplicable design inputs are included or correctly translated into the design documents, anddeviations from those requirements are controlled. Design verification is provided through thenormal supervisory review of the designer's work.

Section 4 Procurement Document Control

Procurement documents for items and services obtained by or for MHI-NESH shall include orreference documents describing applicable design bases, design requirements, and otherrequirements necessary to ensure component performance. The procurement documents arecontrolled to address deviations from the specified requirements.

Section 5 Instructions, Procedures, and Drawings

MHI-NESH shall provide documents such as, but not limited to, written instructions, plantprocedures, drawings, vendor technical manuals, and special instructions in work orders, todirect the performance of activities affecting quality. The method of instruction employed shallprovide an appropriate degree of guidance to the personnel performing the activity to achieveacceptable functional performance of the SSC.



Section 6 Document Control

MHI-NESH shall establish controls for the issuance and change of documents that specifyquality requirements 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 superceded or obsoletedocuments.

Section 7 Control of Purchased Items and Services

MHI-NESH shall establish measures, such as inspection of items or documents upon receiptor acceptance testing, to ensure that all purchased items and services conform to appropriateprocurement documents.

Section 8 Identification and Control of Purchased Items


Section 9 Control of Special Processes


Section 10 Inspection

MHI-NESH does not perform inspection activity in the DC stage. Suppliers will perform thisactivity. So MHI-NESH requires the suppliers to perform following items.

Suppliers shall establish documented instructions to ensure necessary inspections areperformed to verify conformance of an item or activity to specified requirements or to verifythat activities are satisfactorily accomplished. These inspections may be performed bypersonnel in the line organization through the independent verification (IV)/ simultaneousverification (SV), or similar process that utilizes knowledgeable personnel to perform theverification function.

Section 11 Test Control

MHI-NESH does not perform test in the DC stage. Suppliers will perform this activity. So MHI-NESH requires the suppliers to perform following items.

Suppliers shall establish measures to identify required testing that demonstrates thatequipment conforms to design requirements. These tests are performed in accordance withtest instructions or procedures. The test results are recorded, and authorized individualsevaluate the results to ensure that test requirements are met.

Section 12 Control of Measuring and Test Equipment (M&TE)

MHI-NESH does not perform the control of measuring and test equipment in the DC stage.Suppliers will perform this activity. So MHI-NESH requires the suppliers to perform followingitems.



Suppliers shall establish measures to control M&TE use, and calibration and adjustment at

specific intervals or prior to use.

Section 13 Handling, Storage, and Shipping


Section 14 Inspection, Test, and Operating Status


Section 15 Control of Nonconforming Items

MHI-NESH shall establish measures to identify and control items that do not conform tospecified requirements to prevent their inadvertent installation or use.

Section 16 Corrective Action

MHI-NESH shall establish measures to ensure that failures, malfunctions, deficiencies,deviations, defective components, and nonconformances are properly identified, reported, andcorrected.

Section 17 Records

MHI-NESH shall establish 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.

section 18 Audits

MHI-NESH shall establish measures for line management to periodically review and documentthe adequacy of the process and take any necessary corrective action, audits independent ofline management are not required. Line management is responsible for determining whetherreviews conducted by line management or audits conducted by any organization independentof line management are appropriate. If performed, audits are conducted and documented toverify compliance with design and procurement documents, instructions, procedures, drawings,and inspection and test activities. Where the measures of this part (Part Ill) are implementedby the same programs, processes, or procedures as the comparable activities of Part II, theaudits performed under the provisions of Part II may be used to satisfy the reviewrequirements of this Section (Part III, Section 18).

Section 19 Nonsafety-Related SSCs Credited for Regulated Events

MHI-NESH commits to implement quality requirements to the fire protection system inaccordance with Regulatory Position 1.7, "Quality Assurance," in RG 1.189, "Fire Protectionfor Operating Nuclear Power Plants."



MHI-NESH commits to implement quality requirements to ATWS requirement in accordancewith Generic Letter 85-06 "Quality Assurance Guidance for ATWS Equipment That Is NotSafety Related."

MHI-NESH commits to implement quality requirements to SBO requirement in accordancewith Regulatory Position 3.5,"Quality Assurance and Specific Guidance for SBO EquipmentThat Is Not Safety Related," and Appendix A, "Quality Assurance Guidance for Non-SafetySystem and Equipment," in RG 1.155, "Station Blackout."


Quality Assurance Program (QAP) Description SFor Design Certification of the US-APWR PQD-HD-19005 Revision 0

PART IV REGULATORY COMMITMENTS

NRC Regulatory Guides and Quality Assurance Standards

This section identifies the NRC Regulatory Guides and the other quality assurance standardswhich have been selected to supplement and support the MHI-NESH QAP. MHI-NESHcommits to compliance with these standards to the extent described herein. Commitment to aparticular Regulatory Guide or other QA standard does not constitute a commitment to theRegulatory Guides or QA standards that may be referenced therein.

Regulatory Guides:

Regulatory Guide 1.26, Revision 3, February 1976 - 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.

MHI-NESH commits to the applicable regulatory position guidance provided in this regulatoryguide for US-APWR project.

Regulatory Guide 1.29, Revision 3, September 1978- Seismic Design Classification

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

MHI-NESH commits to the applicable regulatory position guidance provided in this regulatoryguide for US-APWR project.

Standards:

ASME NQA-1-1994 Edition - Quality Assurance Requirements for Nuclear FacilityApplications

MHI-NESH commits to NQA-1-1 994, Parts I and II, as described in the foregoing sections ofthis document.

Nuclear Information and Records Management Association, Inc. (NIRMA) TechnicalGuides (TGs)

MHI-NESH commits to NIRMA TGs as described in section 17 of this document.
