ML103570015

Toshiba Corp., Submittal of Nuclear Energy QA Program Description, Rev 4

ML103570015
Person / Time
Site:	05200044
Issue date:	12/22/2010
From:	Arai K Toshiba Corp
To:	Document Control Desk, Office of New Reactors
References
TOS-CR-DCA-2010-0004
Download: ML103570015 (190)

Text

{{#Wiki_filter:Leading Innovation ))> TOSHIBA CORPORATION 1-1,SHIBAURA 1-CHOME, MINATO-KU TOKYO 105-8001,JAPAN PHONE:(03)3457-3734 FACSIMILE: (03)5444-9195 December 22, 2010 TOS-CR-DCA-2010-0004 10 CRF 52.57(a) ATTN: Document Control Desk U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 Toshiba Corporation Docket Number 52-044

Subject:

Submittal of "Nuclear Energy QA Program Description" Rev 4

Reference:

1. Letter to U.S Nuclear Regulatory Commission (NRC) Document Control Desk from Keisuke Kitsukawa, Technology Executive, Light Water Reactor System, Toshiba Corporation Power Systems Company dated October 27, 2010(ML103080158)

As requested by the Nuclear Regulatory Commission (NRC) Staff, enclosed is "Nuclear Energy QA Program Description" Rev. 4 (Document No. 4401-4) to support review of the Toshiba Corporation application for Renewal and Amendment of the Title 10 Code of Federal Regulations (CFR), Part 52, Appendix A, Design Certification Rule for the U.S. Advanced Boiling Water Reactor (reference 1). Should you have questions on this submittal please contact Mr. Robert W Schrauder, Vice President - Licensing, US ABWR Projects & Technologies, Toshiba America Nuclear Energy Corporation ('TANE") at (704) 548-7640. 7bcY 7 5

Leading Innovation >)> I declare under penalty of perjury that the foregoing is true and correct. Executed on b..e. ,*L0 1, 0 Kenji Arai Senior Fellow Nuclear Energy Systems & Services Division Toshiba Corporation

Enclosure:

1. "Nuclear Energy QA Program Description" Rev 4 (Document No. 4401-4)

Contact Information: Mr. Robert W. Schrauder Vice President - Licensing US ABWR Projects & Technologies Toshiba America Nuclear Energy Corporation 3545 Whitehall Park Drive, Suite 500 Charlotte, NC 28273 RSchrauder@tane.toshiba.com (704) 548-7640 Facsimile: (704) 548-7701 cc: (electronic copies w/o enclosures or attachments) Michael R. Johnson David B. Matthews David Misenhimer Mark Tonacci U. S. Nuclear Regulatory Commission Kenji Arai Masahiro Horiguchi Ryuji Iwasaki Toshiba Corporation

Leading Innovation >)) Richard DiSalvo Robert W. Schrauder Dale R. Wuokko Toshiba America Nuclear Energy Daniel F. Stenger Hogan Lovells US LLP Robert Coward Caroline Schlaseman Randolph Trench MPR Associates MA. McBurnett STP Nuclear Operating Company

TOSHIBA 5 ~ DocumeR F iinN RS-5073525 Document Filing NO. C] Itr=l Co-Controlled Copy Uncontrolled Copy SIN Nuclear Energy QA Program Description l:f-*-I Document No. 4401-4 WIT Revision 4 TOSHIlBA CORPORATION Power Systems Company 1-1, SHIBAURA 1-CHOME, MINATO-KU, TOKYO 105-8001, JAPAN 8, SHINSUGITA-CHO, ISOGO-KU, YOKOHAMA 235-8523, JAPAN

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QA PROGRAM DESCRIPTION INDEX 4401-4 IDX Rev. 4 4401-4 IDX Rev 4 INDEX Rev. Revision Date Index....................................................................................................... 4 Statem ent of Policy and Authority.......................................................... 2

1. Introduction.......................................................................................

3

2. O rganization....................................................................................

3

3. QA Program.....................................................................................

2

4. Design Control..................................................................................

2

5. Procurem ent Docum ent Control.....................................................

2

6. Instructions, Procedures, and Drawings..........................................

1

7. Docum ent Control.............................................................................

3

8. Control of Purchased Material, Equipment, and Services...............

3

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Identification and Control of Materials, Parts and Components..... 2

10. Control of Special Process....................................................................

1

11. Inspection.........................................................................................

3

12. Test Control......................................................................................

3

13. Control of M easuring and Test Equipm ent.......................................

2

14. Handling, Storage and Shipping.....................................................

2

15. Inspection, Test, and O perating Status............................................

1

16. Nonconform ing M aterials, Parts, or Com ponents............................

2

17. Corrective Action.........................................

2

18. Q uality Assurance Records.............................................................

3

19. Audits.................................................................................................

3

20. Non Safety-related SSC Q uality Control..........................................

0 Appendix-1.............................................................................................. 2 Jun.16,'10 Jun.8,'09 Jun.16,'10 Jun.16,'10 Jun.8,'09 Jun.8,'09 Jun.8,'09 May 16,'06 Jun.16,'10 Sep. 16,'09 Jun.8,'09 Jun.8,'09 Jun.16,'10 Jun.16,'10 Jun.8,'09 Jun.8,'09 May 16,'06 Jun.8,'09 Jun.8,'09 Jun.16,'10 Jun.16,'10 Jun.8,'09 Jun.8,'09 Revision No. 4 Effective Date: June 18/ 2010 Approved by TAKAHIKO IIKURA Technology Executive, Nuclear Energy Approved by 0 Prepared by 11_ TETSUO YAr/AITO, Senior Manager KIYOSHAIWASAWA, Quality Assurance QA Dept. NED Dept. NED Issued by Quality Assurance Department, Nuclear Energy Systems & Services Division TOSHIBA 1/1

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QA PROGRAM DESCRIPTION STATEMENT OF POLICY AND AUTHORITY 4401-4 SOP Rev. 2 Statement of Policy and Authority It is the policy of Toshiba Corporation, Power Systems Company (PS), PS Nuclear Energy (PSNE) to attain safe, high quality and reliable items and services through adhering to all quality requirements. All organizations and personnel of PSNE implement Quality Assurance (QA) activities based on the following policies. (1) Achieve satisfactory quality level from customer's perspective. (2) Establish and maintain the system for satisfactory quality. (3) Commit all the departments, groups and personnel to quality formulation. (4) Aim for fundamental improvement by approaching the root causes. (5) Comply with the applicable regulation, codes, and standards. The Vice President has overall responsibility for the quality of design, items and services for which PSNE is responsible, and has established the QA organizations which have sufficient authority, right of access to work areas, and organizational freedom including independence from cost and schedule constraints. Technology Executive, Nuclear Energy also has responsibility for the quality of the design, items and services on behalf of the Vice President. PSNE has established and maintains this QA Program to fulfill all applicable regulatory, codes and standards requirements that include 10 CFR Part 50, Appendix B. All Managers in the QA organizations of PSNE have the authority to implement the QA functions that consist of; (1)assuring that the QA program has been established and is effectively implemented, and (2)verifying compliance to ensure that activities affecting safety-related functions are correctly performed, within their respective areas of responsibility. Implementation of this QA Program to achieve the quality objectives is the basic responsibility of all organizations and personnel within PSNE. Any unsolved questions or problems are brought to my attention for resolution. The implementation of the QA Program is fully supported by PSNE management. Kiyoshi Okamura Vice President Power Systems Company Toshiba Corporation TOSHIBA 1/1

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QA PROGRAM DESCRIPTION Chapter 1 INTRODUCTION 4401-4 Ch-1 Rev.3

1. Introduction 1.1 Scope This Quality Assurance (QA) Program has been established and documented to comply with applicable regulatory, code, standard and customer quality requirements for structures, systems, components and services (hereinafter referred to as "SSC&S") provided by Toshiba Corporation, Power Systems Company (PS), PS Nuclear Energy (hereinafter referred to as "PSNE").

This QA Program includes methods pertaining to the managerial and administrative control that meet the requirements of; (1) Appendix B to 10 CFR Part 50 "Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants" (2) NRC Regulatory Guide 1.28-1985 "Quality Assurance Program Requirements" (3) ASME NQA-l-1994 "Quality Assurance Program Requirements for Nuclear Facility Applications" (4) IAEA Safety Standards Safety Requirements No. GS-R-3 "The Management System for Facilities and Activities" (5) "The Management System for Facilities and Activities"Applicable sections of ASME Boiler and Pressure Vessel Code. The QA Program Description is a top level policy document structured based on the 18 criteria of Appendix B to 1 OCFR Part 50, "Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants". The QA Program Description is applied throughout PSNE, and among others, applicable to the activities affecting safety-related functions of structures, systems and components that prevent or mitigate the consequences of postulated accident that could cause undue risk to the health and safety of the public for supplying to overseas nuclear facilities. In certain cases, selected elements of the QA Program Description are also applied to those SSC&S that are not classified as safety-related, but support safe, economic, and reliable facility operations, or where other NRC guidance establishes quality assurance requirements. Project QA Manual may be developed to, when deemed necessary, supplement the requirements of the QA Programs Description, and provide for specific contractual requirements and alternative quality standards as imposed by the governing regulatory agency and the customer. TOSHIBA 1/6

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QA PROGRAM DESCRIPTION Chapter 1 INTRODUCTION 4401-4 Ch-1 Rev.3 Quality related activities described herein include the following; (1) Preliminary Design (2) Licensing (3) Contract Definition (4) Preparation of System Design and Specifications as an architect engineer (AE) including provision of Design Specifications (5) Preparation of Component Design and Specifications as an architect engineer (AE) including provision of Design Specifications (6) Purchasing (including Supplier Evaluation and Selection) (7) Fabrication and Assembly of Structures, Systems and Components (SSCs) (8) Handling, Cleaning, Storage, Packaging and Shipping (9) Inspection and Test (10) Installation and Erection of SSCs (11) Preoperational and Start-up Testing (12) Field Servicing including Pre-Service-Inspection and In-Service-Inspection (13) Repair and Modification of SSCs TOSHIBA 2/6

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QA PROGRAM DESCRIPTION Chapter 1 INTRODUCTION 4401-4 Ch-1 Rev.3 1.2 Glossary The definitions and abbreviations, described below, are used in PSNE. For other terms, definitions described in NRC 10CFR50.2 Definitions, ASME NQA-1 PART1, Introduction "Terms and Definitions", and ASME Sec III NCA-9000 Glossary are referred to. ASME The American Society of Mechanical Engineers. AUDIT A planned and documented activity performed to determine by investigation, examination, or evaluation of objective evidence the adequacy of and compliance with established procedures, instructions, drawings, and other applicable documents, and the effectiveness of implementation. DESIGN CONTROLLING DOCUMENTS Design Controlling Documents provide the basis for detailed system, structure and component design. The Design Controlling Documents typically include the documents (a) through (c) below. (a) General Design Documents; General Design Documents ("GDD") provide a part of design criteria to be applied to safety-related structures, systems and components. GDD may be issued as preliminary version and verified at a later date after incorporating the results of each system/equipment design. GDD include the following documents; - Seismic Floor Response - Analysis Data Sheet & Analysis Reports - Fire Protection Requirement & Fire Hazard Analysis Report - Shielding Design Specification, Requirement for Radiation Shielding Thickness, & Radiation Zone Map - General Arrangement (b) System Design Documents; System design documents specify the requirements for safety-related systems. Typical system design documents include System Design Description, Piping & Instrumentation Diagram (P&ID), Interlock Block Diagram (IBD), Instrumentation Electrical Diagram (IED) and Datasheets TOSHIBA 3/6

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drawings, specify the requirements for safety-related components.

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NED, Shop Organization, Regional (Subsidiary)

Organization, and site organization(s) for particular field activities. LINE-QA/QC ORGANIZATION The applicable organization and position(s) shown below, which is involved in the quality assurance and/or quality control activities for specific plant (project). These activities include issuance of QA/QC specifications or procedures, performing/witnessing in-process inspections and/or verification for acceptance. (a) Project QA Engineer NQA (b) QC Shop Organization (c) QA for Regional (Subsidiary) Organization (d) QA for Site Organization NED Toshiba Corporation, Power Systems Company, Nuclear Energy Systems & Services Division. PROCUREMENT ORGANIZATIONS The applicable organization(s) shown below, involved in the procurement activities such as issuance of purchase order. (a) Procurement Organization NED (b) Procurement Shop Organization (c) Procurement staff for Regional (Subsidiary) Organization (d) Procurement staff for Site Organization PROJECT ORGANIZATION The applicable organization shown below, involved in the project management activities such as authorizing job scope for a specific project, establishing master engineering schedule. (a) Project Organization NED TOSHIBA 4/6

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QA PROGRAM DESCRIPTION Chapter 1 INTRODUCTION 4401-4 Ch-i Rev.3 (b) Project Organization Regional (Subsidiary) Organization PROJECT REQUIREMENT DOCUMENT Project Requirement Documents provide some definitions and measures to be applied commonly to system and equipment designs, such as unit definition, naming rules to items for a specific plant, definition of safety/quality group classification, definition of seismic category. QA STAFF ORGANIZATIONS The applicable organization and position(s) shown below, which is involved in the quality assurance activities such as establishing and maintaining the quality system documents, vendor evaluation control, regular assessment of the QA program. (a) QA Staff NQA (b) QA, Shop Organization (c) QA for Regional (Subsidiary) Organization (d) QA for Site Organization REGIONAL (SUBSIDIARY) ORGANIZATION The organization that PSNE establish or appoint to implement applicable portion of PSNE QA Program for particular purposes, located at regional facility, supplier facility, or site location, wherever the work to be performed. SHOP ORGANIZATION The organization belonging to or governed by PSNE, implementing the applicable portion of PSNE QA Program, and having responsibilities for design, purchasing, fabrication, inspection, testing, field services, repair, modification. SURVEY A documented evaluation of an organization's ability to perform applicable activities as verified by a determination of the adequacy of the organization's quality program and by a review of the implementation of that program at the location of the work. TECHNOLOGY EXECUTIVE(s) Technology Executive, Nuclear Energy (TE-NE) used in this QA Program Description means one of the most senior management level positions for PSNE, as serving concurrently as for NED, and responsible for the performance of technical and QA activities for products and services for which PSNE responsible. TOSHIBA 5/6

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QA PROGRAM DESCRIPTION Chapter 1 INTRODUCTION 4401-4 Ch-1 Rev.3 VICE PRESIDENT (VP) Vice President (VP) used in this QA Program Description means the top management of PSNE, as serving concurrently as the top management of NED. Executive Vice President (EVP) may be used interchangeably to show the same position of VP. TOSHIBA 6/6

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QA PROGRAM DESCRIPTION Chapter 2 Organization 4401-4 Ch-2 Rev.3

2. Organization 2.1 General The authority and responsibilities of personnel and organizations performing activities affecting quality are established and described herein and in the PSNE documents which constitute a part of the QA Program.

These activities include performance of functions to achieve the quality objectives as well as those to assure quality. The QA functions consist of; (1) assuring that the QA program has been established and is effectively implemented, and (2) verifying compliance by checking, auditing and inspecting to ensure that activities affecting quality are correctly performed. Those personnel and organizations assigned to QA functions are given the sufficient authority and organizational freedom when opposed to safety considerations, to; (1)identify quality problems, (2)initiate, recommend and/or provide solutions, (3)verify implementation of solutions, and (4)assure that further processing, delivery, installation or use is controlled until proper disposition of nonconformance, deficiency or unsatisfactory condition has taken place. Such personnel and organizations have the direct access to the relevant PSNE management where appropriate action can be effected. The authority and organizational freedom with total independence from cost and schedule constraints are provided to the personnel and organizations performing QA functions. 2.2 Organizational Structure Fig.2.1 shows the functional organization structure of PSNE designated to satisfy the commitments of the QA Program Description, for design, purchasing, fabrication, installation, erection, inspection, testing, field service, and modification and repair. It consists of four major organizational units. They are (1)Nuclear Energy Systems & Services Division (hereinafter referred to as "NED"), (2)Shop Organization, (3)Regional (Subsidiary) Organization, and (4)Site Organization for particular site construction and/or field services. Specific organizational details, including authority, responsibilities and interfaces are established and documented in PSNE formal Quality system document. Vice President, Power Systems Company (hereinafter referred to as "VP") maintains the overall responsibility for activities affecting quality for structures, systems, components and services (SSC&S) for which PSNE responsible. TOSHIBA 1/12

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QA PROGRAM DESCRIPTION Chapter 2 Organization 4401-4 Ch-2 Rev.3 The overall responsibility include appointing Senior Managers, providing human resources where needed, providing Statement of Policy for QA Program Description, approval of PSNE Regulation and Procedures (A structure of the QA system documents PSNE is shown in para3.2 of this QAPD), review of the status and adequacy of the QA Program, and approval of letter report to be issued to NRC under 10CFR21. VP also has the responsibility for taking leadership in promotion, commitment, and regular assessment for Safety Culture The Technology Executive(s) for NED (hereinafter referred to as "TE") acts on behalf of VP, and has a responsibility for implementing all activities affecting quality that include approval of the QA Program Description, QA manuals NED, NED level procedures, review of the status and adequacy of the QA Program and evaluation of defects and noncompliance through attending a board for 1 OCFR2 1. TE reports to VP pertaining to the performance of activities within the scope of his responsibility. The Quality Assurance, NED (hereinafter called "NQA") serves as the key QA organization which has sufficient authority, access to work areas and organizational freedom including sufficient independence from cost and schedule constraints when opposed to safety considerations. NQA is responsible for establishing and issuance of the QA Program Description and PSNE top level policies and procedures which are applied to all activities affecting quality within PSNE. NQA is also responsible for measuring and auditing the various functional organizations within PSNE. PSNE has established an in-house quality-committee to provide QA communication within the organizations PSNE. Functions of the committee include deliberation of PSNE level quality system documents and NED quality manuals & procedures, and providing medium for evaluating revision/addendum of applicable regulatory, code & standard requirements to assure PSNE quality program coverage, uniformity consistency and continuity. Quality Manuals and referencing quality procedures/standards issued by other units are evaluated commensurate with the importance to safety and complexity of the work, to assure conformance with applicable regulations, codes, standards, the QA Program Description and PSNE top level policies and procedures. NQA is responsible for assessing the status and adequacy of the overall QA Program of PSNE on a periodic basis (refer to Chapter 3, "QA Program"). Shop QA organization is responsible for establishing, maintaining and implementing QA Program within their areas in compliance with the applicable regulations, codes, standards, in addition to the QA Program Description and PSNE top level policies TOSHIBA 2/12

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QA PROGRAM DESCRIPTION Chapter 2 Ormanization 4401-4 Ch-2 Rev.3 and procedures. NQA conducts internal audits of the shop QA organizations. 2.2.1 Nuclear Energy Systems & Services Division (NED) (1) Quality Assurance, NED Quality Assurance, NED (NQA) serves as the key QA organization of PSNE and is assigned the following functions. QA Staffs in NQA are responsible for establishing and issuance of the QA Program Description and PSNE top level policies and procedures which are applied to all activities affecting quality throughout plant life. QA Staffs, in addition, have the following functions; (a) Conducting internal audits within NED, the site organization, the regional (subsidiary) organization, and the Shop QA organization to assure that appropriate (down-stream) procedures, (in-house) standards and instructions have been established and effectively implemented in compliance with the applicable Codes, Standards, Regulations, QA Program Description, and PSNE top level policies and procedures, as adequate for the nature, scale and complexity of their assigned job scope. (b) Vendor evaluation and qualification control which include establishing the Survey/Audit Schedule and Survey/Audit Plan, and issuing the Qualified Vendors List. (c) Evaluation and qualification of Lead Auditors/Auditors within NED. (d) Control of QA Records. This includes provisions for generation, collection, review, approval, transmittal or storage, maintenance and retrieval of QA Records. (e) Assessment of the status and adequacy of the QA Program, PSNE regularly that includes a management review of the effective implementation of and corrective actions taken in the QA Program (refer to chapter 3 "QA Program"). (f) Indoctrination and training of personnel on the QA Program Description, PSNE Regulations and Procedures, quality-related manual, (down-stream) procedures, (in house) standards and QA related applicable Codes, Standards and regulations. (g) Control of Nonconformance originated from NED and corrective actions which include identifying quality problems, initiating, recommending and providing solutions. It also includes verification of implementation of solutions, and assures controls of further processing, delivery, installation or use. TOSHIBA 3/12

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QA PROGRAM DESCRIPTION Chapter 2 Organization 4401-4 Ch-2 Rev.3 (h) Representing PSNE to NRC and other government authorities on matters related to the QA Program. The Project QA Engineer in NQA is responsible for QA activities which are implemented in accordance with contract requirements of specific projects. The Project QA Engineer has the following functions; (a) Review of inquiry and contract documents received from a customer. (b) If required, the Project QA Engineer obtains customer's agreement on the quality planning documents and incorporates or makes reference to these documents in procurement documents and/or instructions to be forwarded within PSNE and vendor(s). (c) Issuance or provision of QA specifications to be included or referenced in procurement documents. The QA specifications include, as applicable, QA Program requirements, right of access, documentation requirements for QA/QC activities, nonconformance control and quality related requirements on spare and replacement parts. (d) Pre-award evaluation of QA/QC proposals submitted by potential vendors. (e) Conducting pre-procurement review with responsible Engineering/Design Organization and/or Procurement Organization, as necessary, to assure full understanding of the QA specifications. (f) Review of QA/QC documents submitted by vendors to assure that the quality planning and the QA specifications are correctly interpreted. (g) Performing in-process and/or acceptance verifications to check the acceptability of items procured. This activity includes preparation of an acceptance checklist prior to conducting source verification. (h) Surveillance/monitoring of vendor activities during fabrication to assure conformance to specified requirements. (i) Review of vendor certification documents, such as Certified Material Test Reports and Certificates of Compliance. (j) Release control of procured items and certification of product quality. (k) Control of nonconformances and corrective actions pertaining to purchasing which include identifying quality problems, initiating, recommending and/or providing solutions. It also includes verification of implementation of solutions, and assures control of further processing, delivery, installation or use. (1) Control of QA Records for the specific project, including vendor records. TOSHIBA 4/12

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QA PROGRAM DESCRIPTION Chapter 2 Organization 4401-4 Ch-2 Rev.3 (in) Issuance of Project QA Manual,when deemed necessary, that specifies the organizations that involve in the project, supplements the requirements of the QA Program Description, and provides for specific contractual requirements and alternative quality standards as imposed by the governing regulatory agency and the customer, as applicable. (n) Planning and instructing preparation of basic QA input to customer bid specifications. (o) Assigning site QA engineer as representative of NQA. (p) NQA assures that customer, customer's architect engineer (AE) or constructor conform to applicable PSNE installation requirements, where necessary, by appropriate measures. NQA or representative of NQA at the site organization takes appropriate measures such as; Reviewing customer /customer's AE /constructor's (hereinafter called "C/CAE/C") quality related documents for installation.

• Performing site surveillance/monitoring to verify activities by C/CAE/C.
• Providing or recommending solutions or corrective actions on installation quality problems.

(2) Project Organization, NED Project Organization, NED is responsible for managing project activities and controlling documents. These functions include; (a) Communication with the customer for technical matters. (b) Coordination of contract review. (c) Establishing or providing Project Requirement Documents which include authorizing job scope for a specific plant (project), control procedure for documents received from or submitted to the customer, and definition of Safety/Quality group classification. (d) Establishing the Controlled Document List and list of documents to be submitted to the customer for the specific project. (e) Preparation of the Item List (f) Establishing or providing the Master Engineering Schedule. TOSHIBA 5/12

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QA PROGRAM DESCRIPTION Chapter 2 Organization 4401-4 Ch-2 Rev.3 (3) Procurement Organization, NED Procurement Organization, NED is responsible for procurement of subcontracting services orders are placed directly from NED to vendors. These functions include; (a) Selection of vendors for purchasing of materials, equipment and services where orders are placed directly from NED. (b) Issuance of Purchase Orders. (4) Engineering/Design Organization, NED Engineering/Design Organization, NED is responsible for design and. engineering activities those functions include the following and are implemented as specified in "Chapter 4, Design Control" of this QAPD. (a) Applicable design input, such as design basis, performance requirements, regulatory requirements, Codes and Standards, are identified and documented, and their selection reviewed and approved. (b) Assuring translation of the design input into the appropriate design documents. (c) Assuring that appropriate quality standards are specified and included in the design documents, and that deviations from such standards are controlled. (d) Assuring design analysis is performed in a planned, controlled and documented manner. (e) Verifying the adequacy of design. (f) Control of design changes and incorporation into design documents. (g) Reviewing and revising the design process and verification procedure, when deemed necessary as a result of corrective actions taken. (h) Identifying and controlling design interfaces. (i) Providing the design documents as QA Records for storage, retention, and retrieval. Review, approval, issuance and distribution of design documents under the controlled document system. (k) Controlling nonconforming items disposed of as "use-as-is" or "repair". (1) Controlling changes in the field. (m)Preparation, review, approval and issuance of procurement documents. (n) Pre-award evaluation to technical proposals received from potential vendors. (o) Review of customer's contract documents. (p) Providing Design Specifications to the owner prepared in response to the contract agreement. TOSHIBA 6/12

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QA PROGRAM DESCRIPTION Chapter 2 Organization 4401-4 Ch-2 Rev.3 (q) Providing technical specification for field installation of PSNE supplied items. (r) Dedication control of Commercial Grade Items & Services. (5) Field Engineering Organization, NED Field Engineering Organization, NED is assigned the following responsibilities; (a) Providing overall plant construction schedule. (b) Providing site management and coordination of site QA planning and services provided by the line-QA/QC Organization for field installation of PSNE supplied equipment and systems. Coordination may include field engineering services from the Engineering/Design Organization. (c) Providing written instruction for electrical and instrumentation testing, preoperational testing, and start-up testing for PSNE supplied equipment and systems. (d) Dispatching site supervisor and field services for field installation, control and instrumentation

testing, preoperational testing and start-up

testing, maintenance and modification activities.

(6) Supporting Organization, NED Supporting Organization provides various type of supporting activities for each organization, those include the following functions. (a) Licensing Engineering Support. (b) Material Engineering that includes; (i) Issuance of special requirements for materials to be applied uniformly within PSNE. (ii) Review of material specification issued by Engineering/Design organization when required. (c) Information System that include; (i) Receipt, storage and retrieval of QA Records. (ii) Establishment and maintenance of electronic document control system. (iii) Filing and maintenance of Codes, Standards and regulations. (iv) Establishment and maintenance of CAE system. (d) Commercial that include; (i) Communication with the customer for marketing and commercial matters. (ii) Budget control and estimate for the project/plant. (e) Promotion of Safety Culture that include; (i) Providing training, assessing the status and providing feedback based on the result of the assessment of Safety Culture. TOSHIBA 7/12

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QA PROGRAM DESCRIPTION Chapter 2 Organization 4401-4 Ch-2 Rev.3 2.2.2 Shop Organization Toshiba Keihin Product Operations is the shop organization having responsibilities for design, purchasing, fabrication, inspection, testing, installation, field servicing, repair, modification and QA activities within its scope. The scope includes supply of nuclear reactor components (e.g. Core Support Structure, Reactor Internal Components, Control Rod and Control Rod Drive system) and Steam Turbine and Generator. Toshiba Fuchu Complex is also shop organization that scope includes supply of instrumentation and control components such as Plant Main Control Room Panel, Neutron Monitoring System and Reactor Trip & Isolation System. Brief descriptions of major functions within the shop organizations to implement the QA program are presented below. (1) QA, Shop Organization QA, Shop Organization is responsible for establishment, maintenance and implementation of the Shop QA Program in compliance with applicable Codes, Standards, regulations and the PSNE top level policies and procedures. The QA has the authority and organizational freedom when opposed to safety considerations, to identify quality-related problems, initiate, recommend, and/or provide solutions to conditions adverse to quality and to verify implementation of such solutions. The each QA manager is provided with a direct line of communication to the senior management on all quality-related matters to perform this function. The QA also has the following responsibilities for their areas of responsibility. (a) Vendor evaluation and qualification control which include issuing the Qualified Vendors List for orders those are placed by the shop organization. (b) Evaluation and qualification of Lead Auditors/Auditors. (c) Conducting internal audits within the Shop Organization to assure that appropriate (down-stream) procedures, (in-house) standards and instructions have been established and effectively implemented. (2) QC, Shop Organization The QC, Shop Organization is responsible for verifying that activities affecting the quality of structure, systems, components and services which are supplied or procured by the Shop Organization, have been correctly performed. The assigned responsibility includes the following; TOSHIBA 8/12

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QA PROGRAM DESCRIPTION Chapter 2 Organization 4401-4 Ch-2 Rev.3 (a) Performing in-process and/or acceptance verifications to check the acceptability of items procured. (b) Performing in-process examination/inspection and/or final inspection/testing to verify the acceptability of processes specified on a shop traveler. (c) Monitoring special processes such as welding, heat treatment. (d) Generation of QA Records as documented evidence of verification. (e) Issuing the certification of product quality. (f) Reviewing vendor certification documents which include Certified Material Test Reports and/or Certificates of Compliance. (g) Control of nonconformances and corrective actions pertaining to purchasing and in process activities. (h) Assigning site QC representative to assure that the C/CAE/C conforms to applicable installation requirements, where necessary. (i) Performing site inspection and/or testing. (3) Engineering/Design, Shop Organization Engineering/Design, Shop Organization is responsible for design and engineering activities including the following functions within their assigned areas of responsibility; (a) Applicable design input, such as design basis, performance requirements, regulatory requirements, Codes, Standards and upper level design output which may be provided from the Engineering/Design Organization of NED, are identified and documented, and their selections reviewed and approved by the responsible design engineer and manager. (b) Assuring translation of the design input into the appropriate design documents. (c) Assuring that appropriate quality standards are specified and included in the design documents, and that deviations from such standards are controlled. (d) Assuring design analysis is performed in a planned, controlled and documented manner. (e) Verifying the adequacy of design. (f) Control of design changes and incorporation into design documents. (g) Reviewing and revising the design process and verification procedure, when deemed necessary as a result of corrective actions taken. (h) Identifying and controlling design interfaces. (i) Providing the design documents as QA Records for storage, retention and retrieval. TOSHIBA 9/12

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QA PROGRAM DESCRIPTION Chapter 2 Organization 4401-4 Ch-2 Rev.3 (j) Reiew, approval, issuance and distribution of design documents under the controlled document system. (k) Controlling nonconforming items disposed of as "use-as-is" or "repair". (1) Controlling changes in the field. (m)Preparation, review, approval and issuance of procurement documents. (n) Pre-award evaluation to technical proposals received from potential vendors. (o) Review of customer's contract documents, and NED requirements. (p) Providing technical specification for field installation of the supplied items. (q) Dedication control of Commercial Grade Items & Services. (4) Production Control, Shop Organization Production Control, Shop Organization is responsible for the following; (a) Production scheduling and progress control. (b) Storage and issuance control of materials, and parts. (5) Manufacturing, Shop Organization Manufacturing, Shop Organization is responsible for the following; (a) Conducting procedures and performance qualifications for special processes. (b) Maintenance of shop facilities. (c) Performing machining, cutting, assembly, special processes, etc.. (6) Procurement, Shop Organization Procurement, Shop Organization is assigned the following responsibilities within their areas; (a) Selection and purchasing of materials, equipments, parts and services from vendors to which orders are placed by the Shop Organization. (b) Issuance of Purchase Order. TOSHIBA 10/12

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QA PROGRAM DESCRIPTION Chapter 2 Organization 4401-4 Ch-2 Rev.3 2.2.3 Regional (Subsidiary) Organization, Site Organization, and Contractors The organization structure for a special plant, project, and/or job may vary depending upon the nature, scale and complexity of them. Contracts and/or agreements that PSNE may establish, extend the quality program requirements described herein and/or invoked by the specific plant/project contract to the multiple organizations such as site, regional (subsidiary) organization, and contractors. 2.2.4 Major delegation work to outside of PSNE Design specifications, Design Controlling Documents and procurement documents for Reactor Pressure Vessel and Containment Vessel for BWR(ABWR) plant are established by NED Engineering/Design Organization, and issued to a subcontractor(s) such as IHI in the manner specified in chapter4, 5 and 8 of this QAPD. The scope of the subcontractor(s) work includes product design, procurement of materials and fabrication. NED verifies the implementation of the subcontractor(s) in accordance with chapter 8 of this QAPD. TOSHIBA 11/12

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Engineering/Design Organization, NED IIQuality Assurance (QA), NED I Field Engineering Organization, NED I L Supporting Organization, NED Shop Organization Remarks;

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QA PROGRAM DESCRIPTION Chapter 2 Oraanization 4401-4 Ch-2 Rev.3 Vice President, Power Systems Company Project Organization, NED Technology Executive(s) for NED Procurement Organization, NED Engineering/Design Organization, NED I-I Quality Assurance (QA), NED I Field Engineering Organization, NED I Remarks;

• a : It is(will be)established for some regions, or specific project
• b : It is (will be) established at sites for specific projects EJQA organization Quality-related communications L

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QA PROGRAM DESCRIPTION Chapter 3 QA PROGRAM 4401-4 Ch-3 Rev.2

3. QA Program 3.1 General (1) The QA Program is established, documented and implemented in compliance with all applicable regulatory requirements, Codes and Standards to be applied to activities affecting quality for PSNE supplied systems, services and components.

Projects, in many cases, may proceed simultaneously on those stages of design, purchasing, fabrication, installation, testing and field servicing. The QA Program Description applies to not only those quality elements of the organizational units of PSNE, but also quality elements where necessary, of external organizations such as vendors for which PSNE retains responsibility. The QA Program is documented in a formal controlled document system. (2) When revision to the QA Program which has been approved by NRC is required as a result of annual review, following regulatory requirement changes, etc., PSNE shall notify the US NRC of any major changes of the QA Program described herein, prior to implementation. Major changes include any program related changes in the QA Program which may compromise its effectiveness as specified in 10CFR50.54(a)(4). PSNE shall notify the NRC of the changes that do not reduce the commitments in the QA Program Description such as organizational changes in PSNE, as specified in 10CFR50.54(a)(3) within 90 days after implementation. (3) The QA Program is verified, in the periodic management review, its implementation status and adequacy in the organizations annually as a minimum in a planned and documented manner. The QA Managers in respective organizational units PSNE check results of internal and external audits, nonconformances and corrective actions taken, and external organizations' audit results. Results of the check within the shop, regional and site organizations are summarized and brought to the applicable Manager of the QA organization for his review and forwarded to NQA. These results are incorporated into the NED results for the management review for VP and TE(s). In addition to the above planned manner, status of conditions adverse to quality such as nonconformance trends, corrective actions taken are assessed with frequency commensurate with the work volume of the PSNE activities and plant (project) key dates such as delivery, preoperational testing, fuel loading, start-up testing, completion of the contract. NQA is responsible for implementing the assessment. TOSHIBA 1/6

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QA PROGRAM DESCRIPTION Chapter 3 QA PROGRAM 4401-4 Ch-3 Rev.2 (4) The QA Program provides for performing activities affecting quality under suitably controlled conditions, including the use of appropriate equipment, suitable environmental conditions, and assurance that all prerequisites for the given activity have been satisfied. Control of special processes, skills, tools, and test equipment are prescribed, documented, and implemented. Required inspections and tests are identified on quality planning documents, Shop Travelers and/or equivalent quality control documents. 3.2 Quality System Documentation 3.2.1 Quality System Document Structure The PSNE activities affecting quality are prescribed and documented in the PSNE Regulations and Procedures as PSNE top level policies and procedures, Quality Manuals, (down-stream) procedures, (in-house) standards, and instructions. They are defined as formal Quality System documents. The key documents governing QA activities and their revisions are distributed under controlled conditions to designated organizations and/or personnel. The QA Program Description and the PSNE Regulations and Procedures are commonly applied to the PSNE major organizational units. The Quality System of the respective PSNE major organizational units are documented (or, will be documented prior to commencement of the assigned activities) on the quality manuals, (down-stream) procedures, (in-house) standards, and/or instructions in a manner that meets QAPD and PSNE Regulations and Procedures to fit the functions of the particular organization. The Quality System ~The QA Program Description document structure is shown below. P~SNE Regulations and Procedures common to all PSNE Organizational Units) Quality Manuals of Each Organizational Unit, (down-stream) Procedures, (in-house) Standards, And/or Instructions (within Each Organizational Unit) Work Guides which includes Position Guide Descriptions (within each Department) Fig.3-1 Quality System Document Structure PSNE TOSHIBA 2/6

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QA PROGRAM DESCRIPTION Chapter 3 QA PROGRAM 4401-4 Ch-3 Rev.2 3.2.2 Key documents in the QA Program A brief description of the purpose and scope of key documents governing the safety-related activities to implement the QA program is presented in the followings. (1) Personnel Proficiency in Quality-Related Activities (Doc. No. 3830) This Procedure establishes the minimum personnel proficiency that needs to be equipped with by those who are engaged in the activities performed within PSNE based on the QA Program. This Procedure is commonly applied to all PSNE organizations as one of the PSNE Regulations and Procedures. (2) Review Procedure for the Adequacy of the QA Program and its Effective Implementation (Doc. No. 4301) This Procedure prescribes the review procedure for the adequacy of the QA Program for PSNE and its effective implementation. This Procedure is commonly applied to all PSNE organizations as one of the PSNE Regulations and Procedures. (3) Reporting Procedure for Defects and Noncompliance under NRC 10CFR21 (Doc. No. 4810) This document prescribes responsibilities and procedures for reporting defects and noncompliance under NRC 10CFR21. It is commonly applied to all PSNE organizations as one of the PSNE Regulations and Procedures. (4) QA Manual NED (Doc. No.4401-5) The QA Manual defines the QA Program of NED for supplying systems, services and components in compliance with applicable Codes, Standards, regulations, the QA Program Description (4401-4), and the PSNE top level policies and procedures. The applicable scope of this Manual include supplying non safety-related items and services. (5) ASME QA Manual NED (Doc. No.4401-2) This QA Manual defines the QA Program of NED for ASME Code activities. It has been accepted by the ASME, and the Certificates of Authorization and Accreditation have been issued. Application of this Manual assures that NED operates to the applicable requirements of Section III of the ASME Boiler and Pressure Vessel Code. (6) Engineering and Design Procedure NED (Doc. No. AS-200A001) This Procedure together with supporting procedures, define the design control system. NED performs engineering and design activities using of this Procedure which is in compliance with applicable regulatory requirements such as IOCFR50 Appendix-A, Appendix-B, Regulatory Guides and ASME Code. This Procedure is applied for engineering and design activities within NED. TOSHIBA 3/6

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QA PROGRAM DESCRIPTION Chapter3QA PROGRAM 4401-4 Ch-3 Rev.2 (7) NED Supporting Standards These Standards describe specific requirements and controls for performing activities NED is responsible, and to support the QA Manual NED (4401-5) and ASME QA Manual NED (4401-2). (8) Safety-related QA Manual, Keihin Product Operations (Doc. No. QY-A-535) This QA Manual defines the QA Program in Keihin Product Operations for supplying "safety-related" systems, services and components in compliance with applicable Codes, Standards, regulations, the QA Program Description (4401-4), and the PSNE top level policies and procedures. (9) ASME QA Manual, Keihin Product Operations (Doc. No.QY-A-511) This QA Manual defines the QA Program in Keihin Product Operations for ASME Code activities. It has been accepted by the ASME and the Certificates of Authorization and Accreditation have been issued. Application of this Manual assures that Keihin Product Operations operates to the applicable requirements of Sec. -I[ of the ASME Boiler and Pressure Vessel Code. (10) Supporting Standards, Keihin Product Operations These Standards contain documentation describing specific requirements and controls for performing activities Keihin Product Operations is responsible, and to support the above Safety-related QA Manual (QY-A-535) and ASME QA Manual (QY-A-5 11). (11) Fuchu Complex Quality Standards for Safety-related activities These standards defines the QA Program in Fuchu Complex for supplying "safety-related" systems, structures, components, and services in compliance with applicable codes, standards, regulations, the QA Program Description (4401-4), and the PSNE top level policies and procedures. 3.3 PSNE Position to NRC Regulatory Guides The QA Program is established in compliance with NRC 10CFR50 Appendix B, ASME NQA-1-1994, applicable NRC Regulatory Guides, and applicable Sections of the ASME Boiler and Pressure Vessel Code. The applicable quality-related Regulatory Guides & ASME NQA-1-1994, and PSNE alternative positions to these Regulatory Guides are listed in Appendix-i, when applicable, with the specification, alternatives, and exceptions. The quality-related Regulatory Guides may be revised or newly issued. PSNE evaluates the revised or new Regulatory Guides and makes a decision how to incorporate them into the QA Program. PSNE commitments to comply with the Regulatory Guides and PSNE alternative positions are described in the QA Program TOSHIBA 4/6

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QA PROGRAM DESCRIPTION Chapter3 QA PROGRAM 4401-4 Ch-3 Rev.2 Description and submitted to NRC. The revised QA Program is implemented within 30days after receipt of NRC acceptance. The PSNE commitments to comply with applicable Regulatory Guides not listed in Appendix-1 are documented in Standard Design to be certified and/or the licensing application documents for each nuclear power plant. PSNE normally evaluate, determine, and document how to apply Regulatory Guide 1.26-Rev3 1976 (or later revision) "Quality Group Classifications and Standards for Water-, Steam-, and Radioactive-Waste-Containing Components of Nuclear Power Plants" and Regulatory Guide 1.29-Rev3 1978 (or later revision) "Seismic Design Classification" in this manner. The NRC certified Standard Design and/or approved licensing applications documents establish the PSNE position to the applicable Regulatory Guides and alternate positions. 3.4 Indoctrination, Training and Qualification of Personnel (1) Indoctrination and training of personnel performing activities affecting quality are planned and performed in accordance with the established program. The "Personnel Proficiency in Quality-Related Activities" (Doc. No. 3830) prescribes basic personnel indoctrination, training and proficiency requirements, commonly applied to all PSNE organizations. Specific indoctrination and training requirements for the respective organizational unit of PSNE are provided as a part of this QA System commensurate with the scope, complexity and nature of the activities suitable for the function. The indoctrination/training of personnel is performed consistent with the schedule for activities to be assigned. (2) Responsibilities, educational background and experience of PSNE personnel position affecting quality are formally documented in the Quality System documents. (3) Indoctrination and training programs include requirements for personnel performing activities affecting quality, such as inspection, testing, special processes (i.e. nondestructive examination, welding, heat treatment, etc.), operation of shop facilities and audit. Qualification and certification requirements for QA Program auditors are detailed in Chapter 19 of this QA Program Description. (a) Indoctrination Indoctrination covers subjects relating to particular functions and may include: applicable regulatory requirements,

Codes, Standards, Quality System documents of PSNE and other technical documents.

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OA PROGRAM DESCRIPTION Chapter 3 OA PROGRAM 4401-4 Ch-3 Rev.2 (b) Training Training is provided, to achieve initial proficiency, maintain it, and to adapt to changes in technology, methods or job responsibilities. (c) Record Records of the implementation of indoctrination and training may take the form of attendance sheets, training logs, or personnel training records. (4) Qualification requirements for Senior Manager and Group Manager(s) responsible for QA activities (QA Managers) are; an engineering or related science degree and has a minimum of four years of related experience. (3 of the 4 years must include 2 years of nuclear power plant experience and I year of supervisory or management experience. One year of experience performing quality verification activities.) Special requirements shall include management and supervisory skills and experience or training in leadership, interpersonal communication, management responsibilities, motivation of personnel, problem analysis and decision making, and administrative policies and procedures. Individuals who do not possess these formal education and minimum experience requirements should not be eliminated automatically when other factors provide sufficient demonstration of their abilities. These other factors are evaluated on a case-by-case basis and approved and documented by senior management for the QA Managers. TOSHIBA 6/6

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4. Design Control 4.1 General Design of structures, systems and components is controlled to assure safe and reliable performance of products and services to be supplied.

Design control processes are documented in the Engineering & Design Procedure and referencing standards (hereinafter referred to as "Design Control Procedures"). Design Control Procedures include measures to assure that: (a) design input including applicable regulatory requirements and the design basis are specified in a timely manner and corTectly translated in to design documents; (b) quality requirements and standards are specified in design documents; (c) materials, parts, equipment and processes that are essential to the safety-related functions of the structures, systems and components are selected and reviewed for suitability for application; (d) appropriate design verification methods are applied, and where applicable, implemented by individuals or groups not having direct responsibility for the original design-, (e) design changes are controlled in the same manner as the original, including review and approval by the same organization that performed the original review and approval unless otherwise specified; and (f) design interfaces are identified and controlled. Design control measures are applied to items such as; reactor physics, stress, thermal, hydraulic and accident analyses; compatibility of materials; accessibility for in-service inspections, maintenance and repair; and delineation of acceptance criteria for inspections and tests. 4.2 Design Input The Engineering/ Design organizations PSNE perform design activities at various stages of design, such as preliminary design, system design and component design within their scope of responsibility. Design output documents in the upstream design stage may be a design input of downstream stage design. At each stage of the design, the applicable design input, including design basis, as defined in NRC 10 CFR 50.2 and as specified in US Design Control Document (DCD) and/or licensing application documents, when applicable, perfon-nance requirements, regulatory requirements, Codes and Standards are identified and documented in accordance with Design Control Procedures, and their selection reviewed and approved by the applicable design organizations. TOSHIBA 1/9

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OA PROGRAM DESCRIPTION Chapter 4 Design Control 4401-4 Ch-4 Rev.2 Unique data for a specific nuclear power plant (project) and contractual design basis are also identified and documented as design input. The design input is specified and approved to the level of details necessary to permit the design activity to be properly carried out and to provide a consistent basis for making design decisions, accomplishing design verification measures and evaluating design changes. Changes to the approved design input, including reasons thereof, are identified, approved, documented and controlled in accordance with the Design Control Procedures. 4.3 Design Interface Control The Engineering/Design organizations, NED are primarily responsible for upstream design activities such as preliminary design, system design, definition of design specifications and design for procurement items. The Engineering/Design organizations in the Shop Organizations are responsible for downstream design activities such as equipment design. To assure structure, system and component interface compatibility, applicable design documents are distributed for information, review and coordination by the relevant Engineering/Design organizations. A standard design scope of the respective Engineering/Design organizations (and their inter-relationships) is prescribed in the Quality System Documents, PSNE. For the specific nuclear power plant (project), the project management engineer in Project Organization establishes "Item List" and "Job Scop e Authorization" for overall project coordination. The "Item List" and "Job Scope Authorization" identify the scope of work to be undertaken by the respective Engineering/Design Organizations, PSNE for the specific plant (project). When required by the contract, design documents are also submitted to the C/CAE/C to provide for interface compatibility review and coordination by C/CAE/C design organizations. 4.4 Design Process 4.4.1 Project Requirement Documents and Design Controlling Documents The "Project Requirement Documents" are issued to the applicable Engineering/Design organizations for common application to system and equipment design. The "Project Requirement Documents" contain design basis, definition of Safety/Quality classification, definition of seismic category, special requirements for materials and contract/plant specific data. TOSHIBA 2/9

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QA PROGRAM DESCRIPTION Chapter 4 Design Control 4401-4 Ch-4 Rev.2 The Project Requirement Documents are prepared, reviewed, verified where applicable, approved, and distributed as prescribed in the procedure. The Project Requirement Document "Safety/Quality Group Classification and Standards" specifies safety and quality classes for the safety-related structures, systems and components, methods for assigning them to these classes, and the specific quality/industry standards applicable to each class. The safety and quality group classes for structures, systems and components are identified in the applicable System Design Description, Equipment Requirement Specifications, piping and instrumentation diagrams (P&IDs) and drawings. The "Design Controlling Documents" provide the basis for detailed system, structure and component design. The Design Controlling Documents typically include General Design Documents, System Design Descriptions, Equipment Requirement Specifications, piping and instrumentation diagrams (P&IDs), interlock block diagram (IBD), instrument elementary diagram (LED), instrument list and data sheets. Application of materials is determined and identified in design output documents by the responsible Engineering/Design organization. Special requirements for materials are specified, documented, and applied so that they may be applied uniformly throughout PSNE. The Material Engineer issues the special requirements for material, and review material specifications issued by the Engineering/Design organization as prescribed in the QA Manuals. Requirements for manufacturing processes are specified or referenced in the Design Controlling Documents. They are controlled by such as monitoring/reviewing vendor's performance status. Application of commercial grade items is in accordance with Commercial Grade Dedication ("CGD") Program which is established as a part of the QA Program, PSNE. The CGD is an acceptance process to assure that a commercial grade item to be used as a safety related component/part will perform as intended. This process includes identification of the critical characteristics, CG vendor evaluation, as well as the evaluation of applicability of these items. The Engineering/Design organization is responsible for identifying the dedicated items in the design output documents. Final design output documents at each design stage are traceable to the design input by documentation in sufficient detail to permit design verification, and identify assemblies and/or components that are the part of the item being designed. TOSHIBA 3/9

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QA PROGRAM DESCRIPTION Chapter 4 Design Control 4401-4 Ch-4 Rev.2 4.4.2 Standard Plant Design PSNE offers plants (projects) which include the Advanced Boiling Water Reactor ("ABWR") Plants that are designed and engineered to the "Standard Plant" design, specified in US (ABWR) Design Control Document (DCD). PSNE may modify the Standard Plant design and/or perform detail design for specific site conditions, application of new technology, and for updating regulatory, Code & Standard requirements. Unique data for the specific nuclear power plant (project) and those for contractual design basis are incorporated into Standard Plant design documents and are, where necessary, newly issued for the specific plant (project). Standard Plant design documents not required to be modified for a specific plant (project) are commonly applied to PSNE plants (projects). The Project Requirement Documents and (project) Design Controlling Documents provide the engineering/design basis for licensing application to the customer (owner) or his designee, in conformance to the contract agreement. Design Specifications with the Project Requirement Documents and (project) Design Controlling Documents incorporated thereto, are provided when detail design is required by the contract. Design Control Procedures are utilized for these design activities including verification of applicability of PSNE design previously proven based on supplying the same type of system, structure and components supplied by PSNE and their satisfactory operation in Japan. In addition to using the certified Standard Design, PSNE may develop a new Standard Design for certification proceeding under 10CFR52, and equipment qualification under NRC's topical report process. 4.4.3 Design of Purchased Items and Materials Design documents of PSNE for items and materials to be procured (including instrumentation, and controls and materials used in the fabrication of PSNE manufactured items) consist of one or more of the following documents: procurement specification which specify general and specific technical requirements; part drawings which specify the outline drawing and interface requirements; the (project) Design Controlling Documents; Project Requirement Documents; applicable process control specifications and material specifications. Designs and changes thereto pertaining to procurement items are reviewed, verified, and approved in the prescribed manner. 4.4.4 Equipment Design, Shop Organizations The Engineering/Design organization, NED issues the "Job Order Sheet" to the Shop Organization for specific plant (project) components. The Job Order Sheet makes references to or is attached with technical requirements of Project Design Controlling TOSHIBA 4/9

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QA PROGRAM DESCRIPTION Chapter 4 Design Control 4401-4 Ch-4 Rev.2 Documents, Project Requirement Documents, material specifications, applicable process control specifications, licensing application documents, customer's contract documents and applicable Codes, Standards and regulations. Design documents for components manufactured by Shop Organization consist of specific detailed Design Drawings, Specifications and Production Drawings necessary to fabricate, inspect and test products. Responsible engineers, Shop Organization assure that design documents conform to the technical requirements provided by NED before release to manufacturing. The "Standard Plant" design documents modified for the specific plant (project) may be used as design documents. The modified portion of the "Standard Plant" design documents are reviewed, verified and approved in the prescribed manner. At appropriate design stages prior to issuance of design output documents, the "Design Review Meeting" may be convened for reviews of design output documents by relevant authorities or organizations involved with the design in addition to the design verification described in para.4.5. Participants of the Design Review Meeting include manufacturing engineer and/or QA/QC personnel, as necessary. 4.4.5 Design Analysis (1) Design Analysis is performed in a planned and controlled manner and is documented by the Engineering/Design organization. Design analysis documents are legible and in a form suitable for reproduction, filing and retrieval. Design analysis documents are detailed as to purpose, method, assumptions, design input, references and units such that the reviewer can readily review and understand the analysis and verify the adequacy of the results without recourse to the originator. Calculations are identifiable by subject (including structure, system or component to which the calculation applies), originator, reviewer and date; or by other data. (2) Computer Software Computer software developed as a deliverable safety-related product or used in the design, analysis, or operation of safety-related SSC, is developed, controlled, and maintained in accordance with Computer Software Control Program which is established as a part of the QA Program, PSNE, and complying with applicable parts of ASME NQA-1 such as Subpart2.7. The Computer Software Control Program includes provisions for the control of software obtained from external sources. Computer software developed or used for other than safety-related applications is controlled commensurate with the function and other requirement, as appropriate. TOSHIBA 5/9

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QA PROGRAM DESCRIPTION Chapter 4 Design Control 4401-4 Ch-4 Rev.2 (3) Documentation of design analysis Documentation of design analysis includes: (a) definition of the objective of analysis; (b) definition of design input and their sources; (c) results of literature searches or their applicable background data; (d) identification of assumptions and indication of those that must be verified as design proceeds; (e) identification of any computer calculation, including computer type, computer program (e.g., name), revision status, input, output, evidence of, or reference to computer program verification and the basis (or reference thereto) supporting application of the computer program to the specific physical problem; and, (f) review and approval. 4.5 Design Verification 4.5.1 Design Verification of Safety-related SSC & S (1) Prior to issuance of design output documents, design verification is performed by any competent design engineer(s) or group(s) other than those who performed the original design but who may be from the same organization. Verification by the originator's supervisor may be permitted if the supervisor did not specify a singular design approach or rule out certain design considerations and did not establish the design inputs used in the design. If the verification is performed by the originator's supervisor, the justification of the need is document and approved in advance by management of the supervisor. Cursory supervisory reviews do not satisfy the intent of this Program. The "Design Verification Report" is prepared to identify the methods used to verify the design. Design verification, for the level of design activity accomplished, is performed prior to release of documents for procurement, manufacture, construction or release to another organization for use in other design activities except in those cases where this timing cannot be met, such as when data is insufficient. In those cases, the portion of the design not verified shall be identified and controlled by referencing the Design Verification Report in the design output documents. The verification process need not be duplicated for identical design. The applicability of standardized or previously proven designs with respect to meeting pertinent design input is verified for each application. Known problems affecting the standard or previously proven designs and their effects on other features are considered. In all cases, the design verification is completed prior to relying upon the component, system, TOSHIBA 6 / 9

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QA PROGRAM DESCRIPTION Chapter 4 Design Control 4401-4 Ch-4 Rev.2 structure or computer program to perform its function. (2) Where changes to previously verified design have been made, the design verification requires the same process above, including evaluation of the effects of those changes on overall design and on any design analysis upon which the design is based. (3) The design verification methods include, but are not limited to, any one or a combination of the following : performance of design review, alternate or simplified calculation method, or performance of a suitable testing program. Where a test program is used to verify the adequacy of a specific design feature in lieu of other verifying or checking process, it shall include suitable qualification testing of a prototype unit under the most adverse design conditions. (4) At appropriate design stages prior to issuance of design output documents, "Design Review Meeting" may be convened for review of the design output documents by the relevant authorities or organizations involved with the design, in addition to the design verification described in (1)-(3) above. Participants of Design Review Meeting may include QA personnel and material engineer, as necessary. The results of the Design Review Meeting including any necessary actions, when applicable, are documented and controlled. 4.5.2 Design Verification of Non-safety-related SSC & S Design Verification of Non-safety-related SSC & S may be provided through the normal supervisory review of the designer's work, and Design Review Meeting as appropriated commensurate with their function to support safety and reliability, the complexity of design, the degree of standardization, and the similarity with previously proven design. 4.6 Design Change Control (1) Any changes to the design which have been issued as the design output documents are technically justified and subject to design control measures commensurate with those applied to the original design. Measures for identifying, documenting, verifying, approving and informing other design organizations affected by the change are prescribed in the Design Change Control Procedures. The Engineering/Design organization reviewing and approving the original design output documents are responsible for the design change process. When an organization which originally was responsible for approving a particular design document is no longer responsible, Customer (owner) or his designee may designate PSNE as a new responsible organization having demonstrated competence in the design area. In such case, adequate measures to understand the requirements and intent of the original design such as obtaining from customer (owner) the original TOSHIBA 7/9

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QA PROGRAM DESCRIPTION Chapter 4 Design Control 4401-4 Ch-4 Rev.2 design requirements, performing a technical evaluation of the item, shall be made. (2) After delivery of components and during installation, pre-operational and start-up phases at the site, field changes may become necessary in the following cases; (a) Field changes caused by design changes (b) Field changes initiated at the site as a result of unique field conditions. The responsible Engineering/Design organization processes design change in accordance with above para.4.6 (1). Field Change/Clarification Request ("FCCR") is used by the site organization for initiating the process to resolve site problems. The line-QA/QC assigned to site activities, reviews the FCCR to determine whether nonconformance process is required. The field change instruction is established and issued for disposition to address the FCCR. The field change instruction is also used for activities to be performed as a result of the design change. When necessary, the field change instruction is handled as an identified attachment of the nonconformance report. The field change instruction identifies and includes or, makes reference to the following; (a) the components affected, (b) procedures to be followed in making the change, (c) revised design documents to be applied, and (d) the quality requirements to be met. The applicable Engineering/Design organization is responsible for procurement of any replacement parts and services as a result of the change. Revised design documents are technically justified and subject to design control measures commensurate with those applied to the original design. When it becomes necessary to ship products to the site before manufacturing is complete, the instruction is issued which identifies the work to be completed in the field. The instruction identifies and includes or makes reference to the necessary engineering and quality requirements. The site organization is responsible for verifying implementation of the disposition in compliance with the field change instructions. When the change is applicable to other plants (projects), the responsible Engineering/Design organization issues the instruction to other applicable plants (projects) for application. TOSHIBA 8/9

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QA PROGRAM DESCRIPTION Chapter4 Design Control 4401-4 Ch-4 Rev.2 (3) Where a significant design change is necessary because of an incorrect design, the condition is documented and corrective action is taken. The Design Control Procedures including verification procedure are reviewed and revised as necessary by the relevant management. 4.7 Validation and Storage/Submittal of the Design Output Documents Design output documents providing evidence that the design and design verification process were performed in the manner specified herein are collected, validated, stored/submitted, and maintained in accordance with QA record control procedures that are formally documented as a part of the QA Program PSNE. The design output documents to be handled as QA records include not only final design documents, such as drawings and specifications, and revisions thereto but also documentation which identifies the important steps, including sources of design inputs that support the final design. TOSHIBA 9/9

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QA PROGRAM DESCRIPTION Chapter 5 PROCUREMNET DOCUMENT CONTROL 4401-4 Ch-5 Rev. 2

5. Procurement Document Control 5.1 General Measures are established and documented for issuance and control of procurement documents to assure that applicable regulatory requirements, design basis and other requirements necessary to achieve adequate quality are included or referenced in the procurement documents for materials, equipment and services.

PSNE has several organizational units responsible for issuance and control of procurement documents, as described below. Procurement documents issued by any PSNE organizational unit include provisions described in para.5.2, as deemed necessary. 5.2 Contents of Procurement Documents Procurement documents issued by PSNE, and at all tiers of procurement include or make reference to the following, as necessary. (1) Scope of Work Statement indicating the scope of work to be performed by the vendor. (2) Technical Requirements (a) Applicable requirements of the regulations, Codes and Standards including NRC Regulatory Guides as identified in para.3.3 of the QA Program Description. (b) Applicable description in the licensing application documents including the PSNE commitments to comply with the applicable Regulatory Guides not listed in para.3.3, but in the licensing application documents. (c) Technical requirements specified by reference to specific drawings, Codes, Standards, the standard specifications PSNE, the project design specifications, the design controlling documents PSNE, procedures, or instructions including revisions thereto. (d) Inspection & test requirements and acceptance criteria. (3) QA Program Requirements Requirements are specified that the vendor has a documented QA program to implement portions or all of the requirements of applicable Regulations, Codes, and Standards. The extent of the program required depends upon the type and use of the materials, components and services to be procured. The QA program requirements include description that requires the vendor to incorporate appropriate QA program requirements into his procurement documents. (4) Right of Access Right of access is required to provide during inspections and audits of the vendor's TOSHIBA 1/3

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QA PROGRAM DESCRIPTION Chapter 5 PROCUREMNET DOCUMENT CONTROL 4401-4 Ch-5 Rev. 2 plant facilities and records to PSNE personnel, PSNE designated representatives, other parties authorized by PSNE and/or the customer. Extent and frequency of monitoring and source surveillance and inspections are identified, where necessary. (5) Documentation Requirements Technical and QA related documents are required to be submitted to PSNE for information, review or approval. Time of submittal is also to be specified. (6) Nonconformances Requirements for notifying nonconformances and obtaining approval on dispositions of nonconformance are to be specified. The requirements include reporting any defects and deficiencies that could be a substantial safety hazard as defined in 10CFR21 to PSNE for evaluation, as applicable. (7) Spare and Replacement Parts Appropriate spare and replacement parts or assemblies and a description of the technical and QA related data for ordering these parts or assemblies are required to be identified. (8) QA Records to be submitted (9) Requirements of packing, shipping and handling which is compliant with the Regulatory Requirements and PSNE commitments as specified in the attachment-1 of QA Program Description are specified. 5.3 Issuance of Procurement Document The Engineering/Design Organization is normally responsible for ensuring that the procurement documents (or a package of procurement documents) for the items include or make reference to the applicable elements of Para 5.2 above, as adequate for the type, scope and characteristic of the procurement. The Line QA/QC Organization may support to define QA related requirements pertaining to QA program, right of access, nonconformances, QA record submittal and other QA related matters. When subcontracted services are used, the Group requesting those services is responsible for issuance of procurement documents. 5.4 Procurement Document Review The management of the applicable organization is responsible for reviewing procurement documents and changes thereto, to assure that documents supplied to vendor(s) include appropriate provisions to ensure that materials, equipment or services, meet the specified requirements. Upper level management having considerable experience in the area, specialists from TOSHIBA 2/3

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QA PROGRAM DESCRIPTION Chapter 5 PROCUREMNET DOCUMENT CONTROL 4401-4 Ch-5 Rev.2 the appropriate field or organizations concerned, if necessary, may convene meetings for procurement document review. The review is performed and documented to provide objective evidence of satisfactory completion of such review prior to contract award. Changes to the procurement documents as a result of the bid evaluations or pre-contract negotiations are incorporated into the procurement documents. Changes made and their effects are reviewed and completed prior to contract award. The review is performed by the personnel who have access to pertinent information and those who are equipped with adequate understanding of the requirements and intent of the procurement documents perform these reviews. 5.5 Procurement Document Change When changes are made to procurement documents during the procurement processes, they are subject to the same control as that of the original procurement documents. TOSHIBA 3/3

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QA PROGRAM DESCRIPTION Chapter 6 INSTRUCTIONS, PROCEDURES AND DRAWINGS 4 4 01-4 Ch - 6 Rev. 1

6. Instructions, Procedures and DrawiM Documented instructions, procedures and drawings are utilized to communicate quality requirements throughout all phases of design, fabrication, tests and field services.

Activities affecting quality, including methods of complying with 10CFR50, Appendix B, are prescribed, implemented and controlled in accordance with PSNE Regulations and Procedures, Manuals, standards, instructions, specifications and drawings of types appropriate to the circumstances. The respective organizations performing functions to attain quality objectives such as engineering, designing, manufacturing, field services, and QA are responsible for the preparation, review, approval, release, application and maintenance of their own documentation. Structures, systems and components furnished by PSNE are inspected and/or tested in accordance with documented instructions, procedures, and drawings and/or checklists. These documents are used to communicate quality requirements and inspection & test requirements to the responsible personnel including operators or Quality Control (QC) inspectors. These documents may be included in a quality planning document, Shop Traveler or equivalent quality control documents. Specific inspection or test instructions may be used depending on the nature or complexity of the quality control operation to be performed. Documents include or make reference to appropriate quantitative or qualitative acceptance criteria for determining that activities affecting quality have been satisfactorily accomplished. The associated Shop Traveler or equivalent quality control document provides a space for recording or stamping by the individual performing the inspection or test, which becomes the record of the quality control operation. This document provides evidence of operation completion and acceptance status of the item(s) inspected and tested. The applicable Chapters of this QA Program Description contain more detailed information concerning the specific documents prescribing quality-related activities. TOSHIBA

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QA PROGRAM DESCRIPTION Chapter 7 Document Control 4401-4 Ch-7 Rev.3

7. Document Control 7.1 General (1) Procedures and practices are established, documented and implemented to control identification, issuance and use of documents which prescribe activities affecting quality.

These measures provide assurance that documents, including changes thereto, are reviewed for adequacy and approved for release by authorized personnel and are promptly distributed for use to the location where the prescribed activity is performed. Changes to documents are reviewed and approved by the individual from the same organization that approved the original document unless otherwise specified. The person responsible for review has access to pertinent background information upon which to base the review. (2) Personnel participating in activities affecting the quality are provided with the current applicable instructions through established distribution and communication routes. Participating organizations have documented procedures for control of these documents, and the changes thereto, to assure the use of proper documents and to preclude the possible use of outdated or inappropriate documents. (3) PSNE may issue documents by using the computer system, that ftmctions include; (a) preparation, review and approval of documents, (b) distribution including "read" function at PC terminal for the designated person and (c) storage of documents. Documents developed or distributed with the computer system are referred to as "Electronic Media Documents". 7.2 Documents to be controlled (1) Documents that specify quality requirements or prescribe activities affecting quality for a specific plant (project) are identified and controlled as Project Control Document(s) (hereinafter called, "PCD"). (2) Documents, such as the qualified vendors list, audit schedule/plan which are not categorized as PCD but needed in order to meet regulatory requirements, are called Maintenance Control Document(s) (hereinafter called "MCD"). (3) Both PCD and MCD are classified as Control Documents. TOSHIBA 1/3

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QA PROGRAM DESCRIPTION Chapter 7 Document Control 4401-4 ch-7 Rev.3 7.3 Project Control Documents Project Control Documents are divided into Plant Specific Documents and A/E documents. Plant Specific Documents include: (1) Contract Documents (2) Project Design Documents/Drawings (3) Design Input Control Documents in relation to (2) above (4) Design Analysis/Calculations in relation to (2) above (5) Procurement Documents (6) Manufacturing Procedures (7) Inspection, Test, and Examination Procedures (8) Handling/Storage/Shipping Procedures (9) Instruction Manuals (10) Nonconformance Reports A/E Documents include: (1) Project Requirement Documents (2) Project Design Controlling Documents (3) Design Input Control Documents in relation to (2) above (4) Design Analysis/Calculations in relation to (2) above (5) Design Verification Documents in relation to (2) above 7.4 Maintenance Control Documents The following documents are categorized as MCD: 7.4.1 QA-Related Documents: (1) QA Program Description (2) PSNE Regulations and Procedures (3) QA Manual and Supporting Standards (4) Audit Schedule (Internal & External) (5) Audit Plan & Checklist (Internal & External) (6) Qualified Vendors Lists (7) Indoctrination, Training Plans/Records (8) Work Guides (9) Computer Program Verification Reports (10) Qualified Personnel Lists TOSHIBA 2/3

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QA PROGRAM DESCRIPTION Chapter 7 Document Control 4401-4 Ch-7 Rev.3 7.4.2 Standard Fabrication Documents: (1) Manufacturing Specifications (2) Welding Procedure Specifications (WPS), Welding Procedure Qualification Records (PQR) 7.5 Document Control (1) Documents described in para. 7.4.1 (1) and (2), are commonly applied to the major organizational units in PSNE, and are issued and controlled as the PSNE top level documents. (2) Control Documents other than those mentioned above are issued and controlled under document control system of the respective organizational unit. 7.6 Translation Control This paragraph describes requirements for accurate document translation between the English and Japanese languages. (1) Procedures and documents may be translated in both English and Japanese languages for better understanding and implementation of the QA Program. Changes to those documents are handled in the same manner as the originals. (2) Customer (owner) supplied documents may be translated from English to Japanese, when deemed necessary. The translation of these documents is performed under the control of the Manager responsible for the activities requiring document translation. - (3) Documents to be submitted to the customer (owner) or other authorized bodies by PSNE in compliance with the regulatory and Code requirements are prepared in English or in both English and Japanese. When translation from Japanese to English is necessary, it is performed under the control of the Manager responsible for the documents. (4) The English version shall take precedence, if there is any conflict between the two. TOSHIBA 3/3

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QA PROGRAM DESCRIPTION Chapter 8 Control of Purchased Material, Equipment, and Services 4401-4 Ch-8 Rev. 3

8. Control of Purchased Material, Equipment, and Services 8.1 General (1) This Chapter describes measures to assure that purchased materials, equipment and services, whether purchased directly or through vendors, conform to the procurement document(s).

These measures include provisions, as appropriate, for (i) source evaluation and selection, (ii) objective evidence of quality furnished by the vendor, (iii) audit or inspection at the vendor source, and (iv) examination or review of the materials, equipment or services upon delivery or completion (2) The respective PSNE organizational unit has its own documented control system commensurate with the functions of the particular organization. Control measures established at any PSNE organizational units are consistent with provisions described in para. 8.2 through 8. 10 below. 8.2 Procurement Planning Procurement activities are carried out in a planned and controlled manner commensurate with the type, scope and characteristic of the procurement. When applicable, procurement planning is carried out as early as practicable, and in no case later than the start of procurement activities. Procurement planning encompasses (a) through (i) below: (a) procurement document preparation, review and change control; (b) selection of procurement sources; (c) bid evaluation and award; (d) purchaser control of vendor performance; (e) verification (surveillance, inspection, or audit) activities by purchaser, including notification for hold and witness points; (f) control of nonconformances; (g) corrective action; (h) acceptance of purchased material, equipment and services; and, (i) quality assurance records. 8.3 Source Evaluation 8.3.1 Responsibilities QA Staff Organizations are responsible for evaluating vendors in PSNE. TOSHIBA 1/7

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QA PROGRAM DESCRIPTION Chapter 8 Control of Purchased Material, Equipment, and Services 4401 - 4 Ch - 8 Rev. 3 8.3.2 Methods of Source Evaluation and Registration in Qualified Vendors Lists Source evaluation is performed by one or more of (a) through (d) below. The methods of evaluation in the respective PSNE organizational unit are established and documented as procedures or standards. (a) Vendor's technical and quality capability as determined by direct evaluation of its facilities and personnel and implementation status of the vendor's quality assurance program. (b) Review of ASME Certificate issued by the ASME considering NRC IN 86-21 when applicable. (c) Evaluation of the vendor's history of providing an identical or similar product that performs satisfactorily in actual use. The vendor's history reflects current capability. (d) Vendor's current quality records supported by documented qualitative and quantitative information that can be objectively evaluated. The vendors are initially; (1) evaluated by survey using a procedure/checklist and performed by qualified auditors employing the method described in (a) above; or, (2) evaluated by reviewing survey/audit results performed by other organization(s). This method of evaluation is applied for non-safety related SSC&S and as described in (b) above for ASME Certificate holders; or, (3) evaluated by reviewing vendor's history, or currently available quality records as indicated in (c), or (d) above. This method of evaluation is applied for non-safety related SSC&S, and only for the following safety-related procuring equipment, (i) that is relatively simple and standard in design and manufacture, and (ii) for which the standard or automated inspections or tests is performed in its final form after delivery to verify its quality characteristics, or, (4) as an alternative to survey and audit, for US vendors of commercial-grade calibration service, PSNE may accept accreditation of US calibration service vendor by National Voluntary Laboratory Accreditation Program (NVLAP), American Association for Laboratory Accreditation (A2LA), ACLASS Accreditation Services, Laboratory Accreditation Bureau (L-A-B) or International Accreditation Service, Inc. provided the following requirements are met: (i) The accreditation is to ANSI/ISO/IEC 17025 "General Requirements for the Competence of Testing and Calibration Laboratories." (ii) The published scope of accreditation for the calibration laboratory covers the needed measurement parameters, range and uncertainties. (iii) PSNE specify through procurement documents that the calibration TOSHIBA 2/7

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QA PROGRAM DESCRIPTION Chapter 8 Control of Purchased Material, Equipment, and Services 4401 - 4 Ch-8 Rev. 3 certification/report include identification of the laboratory equipment/standards used, and include as-found and as-left data. For qualification of safety-related calibration service vendors other than above, method (1) is applied. The scope of survey, evaluation and review is dependent on the specific scope of work to be provided by the vendor. Evaluation includes acceptance for Commercial Grade Items when this method applied, as specified in EPRI guideline to be used with regulatory supplemental requirements. For the Commercial Grade vendors, the evaluation of their QA program is performed to the specific quality requirements of the applicable project. When evaluation results are acceptable, the vendor is registered on the Qualified Vendors List (QVL). The QA Staff Organization for the respective PSNE organizational unit is responsible for issuing its own QVL. Limitations and scope of vendor permitted to furnish are identified on the QVL. 8.3.3 Maintenance of the Qualified Vendors Lists The qualification of the vendor supplying safety-related SSC&S is effective for three years and updated with the annual audit or evaluation and triennial survey. This evaluation takes into account, where applicable, (1) review of vendor furnished documents and records, such as Certificates of Conformance, nonconformance notices and corrective actions documents; (2) results of previous source verifications, audits and acceptance inspections; (3) operating experience of identical or similar products furnished by the same vendor; and (4) results of audits from other sources, e.g., customer, ASME, or NRC. The QA Staff Organization indicates the vendor status as "inactive" on the QVL, if the annual evaluation has not been performed. In order for the inactive vendor to reinstate active status, the evaluation or audit is conducted. If the PSNE organizational units buy materials, equipment or services from a single vendor, the following methods are applied for the audit. (a) If the vendor from which PSNE buys safety-related equipment or services is the same as that of other organizational units, NQA may coordinate to perform or arrange for the audit of that vendor with the other purchasers to reduce the number of audits. (b) If Shop Organization buys from the same vendor from which NED procures safety-related equipment or services, NQA coordinates the performance and scope of the audit with Shop Organization. In either case, the scope of the audit satisfies the needs of all of purchasers, and the TOSHIBA 3/7

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OA PROGRAM DESCRIPTION Chapter 8 Control of Purchased MaterialEquipment, and Services 4401-4 Ch-8 Rev. 3 audit report is distributed to all relevant purchasers for whom the audit was conducted. The respective PSNE organizational unit is independently responsible for the adequacy of the audit. The triennial evaluation to maintain the qualification is conducted in the same manner as described in para 8.3.2 above. 8.4 Bid Evaluation and Award 8.4.1 Responsibility Procurement Organizations are responsible for bid evaluation and award. 8.4.2 Bid Evaluation and Vendor Selection Organizations having responsibility for bid evaluation and award (Procurement Organizations) send procurement documents to potential vendor(s), for bid invitation. Upon receipt of a written estimate and proposed alterations or exceptions to the procurement documents by the potential vendor(s), the Procurement Organizations evaluate and select a vendor. If necessary, organizations responsible for issuing procurement documents (hereinafter referred to as Procurement Document Responsible Organization = "PDRO") assist the evaluation. When the order is to be placed with a vendor who is not registered on the Qualified Vendors List, evaluation and qualification of the vendor is completed before the contract award. The bid evaluation is performed to evaluate the following items, as applicable to the type of procurement: (a) Technical considerations (b) QA requirements (c) Vendor's personnel (d) Vendor's production capability (e) Vendor's past performance (f) Alternates (g) Exceptions Any proposals for modifications, changes or exceptions to procurement documents are resolved by PDRO, prior to the award of the contract. Changes made as a result of the bid evaluation are incorporated into the procurement documents. The Purchase Order is provided along with (or, refers to) the applicable procurement documents that may have been revised as a result of the bid evaluation to the selected vendor. The Purchase Order identifies document number(s) with revision number(s) of the applicable procurement documents. TOSHIBA 4/7

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QA PROGRAM DESCRIPTION Chapter 8 Control of Purchased Material, Equipment, and Services 4401-4 Ch-8 Rev. 3 8.5 Vendor Performance Evaluation PDRO convenes a meeting with the selected vendor, if necessary, to ensure full understanding of the provisions and specifications of the procurement documents. PDRO requires the vendor to identify planning techniques and processes to be utilized in fulfilling the procurement document requirements by use of their procedures and documentation. PDRO reviews procedures and documentation generated or processed during vendor activities as specified in the procurement documents. P DRO is responsible for communicating necessary information to the vendor for proper control of procurement activities. 8.6 Control of Vendor generated documents Vendor generated documents are controlled with the use of the Vendor Document Lists. The List shows document title & number, revision status and due date of documents to be submitted by the vendor. The status of vendor generated documents is identified on the List. The vendor's documents are reviewed and approved by PDRO with the support of the Material Engineer NED as deemed necessary. Comments and document status resulting from the review are indicated on or referenced in the vendor's documents, and communicated to the vendor. 8.7 Acceptance of Purchased Material, Equipment and Services 8.7.1 Responsibility (1) Line-QA/QC Organizations are responsible for acceptance of purchased material, equipment and services. (2) The organization that places the order such as Engineering/Design Organization or line-QA/QC Organization is responsible for accepting services. 8.7.2 Methods of Acceptance The following methods, or a combination thereof are applied as PSNE acceptance that the material, equipment, and services being furnished by the vendor comply with the procurement requirements. (1) Vendor Certificate of Conformance (2) Source Verification Source verification is implemented by way of PSNE witness, hold or surveillance points. The PSNE witness, hold and surveillance points are planned consistent with the importance and complexity of the purchased materials, equipment and services, and are identified or referenced in the procurement documents. TOSHIBA 5/7

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QA PROGRAM DESCRIPTION Chapter 8 Control of Purchased Material, Equipment, and Services 4401-4 Ch - 8 Rev. 3 (3) Receiving Inspection When receiving inspection is performed, the purchased material and equipment are inspected as necessary to verify conformance to specified requirements, taking into account source verification, audit activities and the demonstrated quality performance of the vendor. Receiving inspection is performed in accordance with established procedures, including review of vendor documentation when applicable. (4) Post-Installation Testing 8.7.3 Acceptance of Services Services, such as third party inspections, engineering and consulting services, and installation, repair, overhaul, or maintenance work may be procured in certain cases. In such cases, the organization placing the order accepts the service by one or more of the following methods: (1) technical verification of data produced; (2) surveillance and/or audit of the activity; (3) review of the objective evidence for conformance to the procurement document requirements such as certifications, stress reports, etc. 8.8 Control of Vendor Nonconformances Purchased materials, equipment and services that do not meet PSNE procurement documents or approved documents, are controlled and disposed of in accordance with the documented instruction specified in procurement documents and the procedures/ standards within each organizational unit of PSNE. (1) When a vendor determines the activity he performed does not conform to the requirements of the procurement documents or vendor generated documents approved by PSNE, the vendor is requested to submit the nonconformance report to PSNE as directed. The nonconformance report includes vendor-proposed disposition (e.g., use-as-is or repair) and its technical justification. (2) When unsatisfactory conditions adverse to quality are detected in a vendor's plant by source verification activities, the vendor is required to issue the nonconformance report to PSNE for acceptance of the proposed disposition and its correction. (3) The line-QA/QC organization reviews the nonconformance report submitted by the vendor with assistance of the responsible Engineering/Design Organization. Use-as-is or repair disposition shall require evaluation of the related documents by the responsible Engineering/Design Organization for technical justification. (4) Additional source verification by PSNE may be required to verify disposition and TOSHIBA 6/7

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QA PROGRAM DESCRIPTION Chapter 8 Control of Purchased Material, Equipment, and Services 44 01 - 4 Ch - 8 Rev. 3 correction of the unsatisfactory conditions. (5) The nonconformance report showing acceptance of the completed disposition is then sent to the vendor and the copy is retained by the line-QA/QC organization. 8.9 Commercial Grade Dedication Program When commercial grade items and services are procured and accepted with Commercial Grade Dedication ("CGD") for safety-related activities, the following activities are performed in conjunction with other requirements of Chapter 8. Application of commercial grade items is in accordance with CGD program which is documented as a part of the QA Program PSNE (refer to para.4.4.1 of the QAPD). (1) Development of procurement planning (2) Source Evaluation (3) Development of acceptance plan (4) Identification and verification of critical characteristics (5) Identification of acceptance method (6) Acceptance of items or services 8.10 Issuance of Documentary Evidence The line-QA/QC organization is responsible for issuing the documentary evidence that materials and equipment conform to the procurement requirements. The documentary evidence is available at the nuclear power plant site prior to installation or use of such materials and equipment. This documentary evidence provides sufficient evidence to identify the specific requirements, including applicable Codes, standards and/or specifications. TOSHIBA 7/7

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QA PROGRAM DESCRIPTION Chapter 9 Identification and Control of Materials, Parts and Components 4401-4 Ch-9 Rev. 2 9.1dentification and Control of Materials, Parts and Components 9.1 General (1) Procedures and practices are established and documented which provide measures for identification and control -of items (The term, "item" is used in place of materials, parts, modules, equipments etc. as defined in NQA-1 PARTI, Introduction). Specific measures for identification and control are documented in the Quality System documents of the respective organizational unit PSNE. (2) Responsible Engineering/Design Organization, NED provides information such as item name & number, plant (project) name, customer name to Shop Organization, and/or a site organization, as applicable, with design controlling documents for identification of completed and semi-fabricated items. (3) Items are identified and controlled by authorized groups specified in the Quality System documents of Shop Organization and/or the site from the initial receipt through fabrication of items up to and including installation and use. Items are identified and controlled by serial numbers, part numbers, or heat numbers in accordance with PSNE serial/part numbering system, the ASME Code, or regulatory requirements. 9.2 Identification of Items at Shop Organization and Site Shop Organization and the site are responsible for identification of items in accordance with the respective QA Systems. The following identification measures are employed. (1) Identification of Item Items are identified (e.g. batch, lot, component & part number) from the initial receipt through fabrication up to and including installation and use. The identification numbers of items are traceable to the applicable

design, manufacturing and QC documents generated during the course of activities.

(2) Physical Identification Physical identification is applied to the maximum extent possible. Where it is either impractical or insufficient, physical separation, procedural control or other appropriate means are employed. TOSHIBA 1/2

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QA PROGRAM DESCRIPTION Chapter 9 Identification and Control of Materials, Parts and Components 4401-4 Ch-9 Rev. 2 (3) Marking The identification marking of items is clear and legible, and does not detrimentally affect functions or service life of items. When items are cut into one or more pieces, markings are transferred to each part of the item prior to cutting. Marking is such that is not obliterated or masked by surface treatment or coating unless other means of identification are employed. (4) Identification and Traceability of Items When specified by the Codes, standards or specifications, specific identification or traceability requirements (such as those to applicable specification and grade of material, heat, batch, lot, part, or serial number, or to inspections or tests performed, or other records), are provided in accordance with the QA Systems of Shop Organization and the Site. (5) Limited Life Items Where specified, items having limited calendar or operating life or cycles are identified and controlled to preclude use of items whose shelf life or operating life has expired. (6) Identification of Items in Storage Production Control, Shop Organization (and the designated group for the site) is responsible for maintaining identification of material and purchased components in storage. The QA Systems of Shop Organization and the site establish controls such as; (a) provisions for maintenance or replacement of markings and identification records due to damage during handling or aging; (b) protection of identifications, on items subject to excessive deterioration due to environmental exposure; and, (c) provisions for updating existing plant records. 9.3 Identification of Completed Items Completed or semi-fabricated items shipped to the customer or the site organizations are identified by the nameplate or other identification marking on the item. The nameplate includes item name & number, plant (project) name and customer name provided by NED. When it is not practical to use a nameplate or identification markings on the item, identification information is documented and delivered with the applicable shipment. TOSHIBA 2/2

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QA PROGRAM DESCRIPTION Chapter 10 Control of Special Process 4401-4 Ch-10 Rev.1

10. Control of Special Process

10. 1 General (1) Procedures and practices are established and documented to assure that special processes including welding, heat treatment and nondestructive testing are controlled and performed by the qualified personnel using qualified procedures.

(2) Measures for the special process control are prescribed in the QA Systems of Shop Organization and the site, and implemented in according with the QA System. A responsible organization is assigned in the Shop and site organization for personnel and equipment qualification for special processes. The measures are in accordance with applicable Regulations, Codes, Standards, specifications, design criteria and other special requirements. 10.2 Measures for Special Processes at Shop Organization and Site (1) Qualification and Records of Personnel, Procedures and Equipment Processes, personnel, procedures and equipment utilized for special processes are qualified to the requirements of the applicable Regulations, Codes and Standards. The following organizations and personnel are responsible for the qualification, control and records to be maintained. Special processes implemented at the site are in accordance with the established site QA Program. (a) Welding The Manufacturing, Shop Organization is responsible for welding procedure qualification, welder training and qualification control and welding equipment maintenance control. (b) Heat Treatment and Forming The Manufacturing, Shop Organization is responsible for the qualification of heat treatment and forming procedures, and equipment maintenance. It also performs the training and qualification of operators performing heat treatment and forming. (c) Nondestructive Examination (NDE) The Level fff examiner is responsible for NDE procedures qualification, NDE personnel training and qualification and NDE equipment maintenance control. ktell : I I -JA 1/2

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QA PROGRAM DESCRIPTION Chanter 10 Control of SDecial Process 4401-4 Ch-10 Rev.1 (2) Conditions necessary for accomplishment of these processes are included in procedures or instructions. These conditions include proper equipment, controlled parameters of the process, and calibration requirements. (3) Acceptance Criteria Requirements of applicable Regulations, Codes and Standards, including acceptance criteria, for the process are specified or referenced in the procedures or instructions. (4) Records Records are maintained as appropriate for the currently qualified personnel, process, and equipment of each special process. (5) Special Requirements For special processes not covered by existing Codes and Standards or where quality requirements specified for an item exceed those of existing Codes or standards, the necessary requirements for qualifications of personnel, procedures, or equipment are specified or referenced in the procedures or instructions. TOSHIBA 2 /2

15

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QA PROGRAM DESCRIPTION Chapter 11 Inspection 4401-4 Ch-11 Rev.3

11. Inspection

11. 1 General (1) Inspections of activities affecting quality are perforined in accordance with the established inspection program.

The inspection program provides measures for qualification of personnel who verify conformance of activities performed to the requirements and inspection planning as a part of the QA System of'the respective organizational unit, PSNE. (2) Inspection requirements and acceptance criteria for the specific plant (project) are specified or approved by the responsible Engineering/Design organization PSNE. 11.2 Personnel (1) Inspections are performed by personnel checking their own work, or by designated qualified personnel (QC personnel) (hereinafter "inspection personnel") who are organizationally independent from personnel performing the work being inspected. When required by regulation, code and standards such as for safety-related items and services, and/or otherwise required by customer contractual and NED specification, inspections are performed by the inspection personnel who are independent of these performing the work. (2) Inspection personnel who verify conformance of work activities for the purpose of acceptance are qualified to perform the assigned inspection task in accordance with .the QA System of each organizational unit, PSNE. Inspections by persons during on-the-job training for qualification are performed under the direct observation and super-vision of a qualified person and verification of conformance is by the qualified person until certification is achieved. 11.3 Inspection Hold Points When the inspection hold points are specified beyond which works shall not proceed without the specific consent of the designated representative, the specific hold points are indicated in appropriate documents, such as travelers, process control sheets as specified by the QA System of the respective organizational unit, PSNE. Consent to waive specified hold points are recorded prior to continuation of work beyond the designated hold point. 11.4 Inspection Planning (1) The Project Requirement Document, "Safety/Quality Group Classification and TOSHIBA 1/3

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QA PROGRAM DESCRIPTION Chapter 11 Inspection 4401-4 Ch-11 Rev.3 Standards" is issued to define methods for assigning systems and components to the "Safety/Quality Group Class", when necessary. The Safety/Quality Group Classification and Standards specify quality/industry standards applicable to each Safety/Quality Group Class. Design documents, such as System Design Descriptions, Equipment Requirement Specifications, P&ID, drawing or combinations thereof, which are approved by the responsible Engineering/Design organization, PSNE provide inspection requirements and acceptance criteria, as well as "Quality/Safety Group Class" for each item. (2) Procedures and instructions are issued to define characteristics to be inspected, inspection method, acceptance criteria and recording objective evidence of inspection results. Where sampling method is used to verify acceptability of a group of items, a procedure is established for the sampling based on recognized standard practices such as statistical methods. 11.5 In-process Inspection (1) PSNE perforins inspections of items during processes or under construction for activities where necessary to verify quality. If inspection of processed items is impossible or impractical, indirect control by monitoring of processing methods, equipment and personnel are provided. Both inspection and process monitoring are performed when control is considered inadequate unless both are performed. (2) A combination of inspection and process monitoring methods, when used, is performed in a systematic manner to assure that the specified requirements for control of the process and qualify of the item are being achieved throughout the duration of the process. Controls, where required, are established and documented for the coordination and sequencing of these activities at established inspection points during successive stages of the conducted processes or construction. 11.6 Final Inspection Final inspections are performed in accordance with the QA System of the relevant organizational unit, PSNE. TOSHIBA 2/3

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QA PROGRAM DESCRIPTION Chapter 11 Inspection 4401-4 Ch-11 Re-.3 (1) Resolution of Nonconformances Final inspections include record review of results and resolution of nonconformances 'identified by prior inspections. The final inspection is planned to arrive at a conclusion regarding conformance of the item to specified requirements. (2) Inspection Requirements Completed items are inspected for completeness, markings, calibration, adjustments, protection from damage, or other characteristics required to be verified. Quality records are examined for adequacy and completeness if not previously so examined. (3) Acceptance The acceptance of the item is documented and approved by authorized personnel. (4) Modifications, Repairs or Replacement Modifications, repairs, or replacements of items performed subsequent to final inspection require re-inspection or retest, as appropriate, to verity acceptability. 11.7 In-service Inspection PSNE may provide inservice inspection or surveillance for the organization responsible for operation ii a planned manner. Inspection methods are established and performed to verify that the characteristics of an item continue to remain within specified limits. Inspection methods include evaluations of performance capability of essential emergency and safety systems and equipment, verification of calibration and integrity of instruments and instrument systems and verification of maintenance, as appropriate. 11.8 Records Records includes, as a minimum, (1) through (7) below; (1) Item inspected (2) Date of inspection (3) Inspector (4) Type of observation (5) Results or acceptability (6) Reference to information on action taken in connection with nonconformances (7) Applicable procedure number and its revision number TOSHIBA 3/3

% 12-011-EP WA-l4401-4 Ch-l2 Rev. 3

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QA PROGRAM DESCRIPTION Chapter 12 Test Control 4401-4 Ch-12 Rev.3

12. Test Control 12.1 General (1) To demonstrate that structures, systems and components will perform satisfactorily in service, tests are performed in accordance with the established test program.

The test program provides test requirements and acceptance criteria, and identifies test documents including procedures and records to be generated as a part of the QA System of the respective organizational units of PSNE. (2) Product test program includes, as appropriate, development testing, prototype qualification testing, procured components qualification testing, proof tests, pressure test including that of the site system pressure test, performance test, field electrical test and calibration test. PSNE test program for preoperational and start-up testing prescribes PSNE activity that will be performed at or for a site. 12.2 Product Test (1) Product test requirements and acceptance criteria are provided or approved by the responsible Engineering/Design organization, PSNE. Product testing is performed in accordance with the test procedures that specify or make reference to the requirements and acceptance criteria contained in the applicable design documents. (2) The test procedures include or reference test objectives and provisions for assuring that prerequisites for the given test have been met, that adequate instrumentation is available and used, that necessary monitoring is performed and that suitable environmental conditions are maintained. Prerequisites include the following, as applicable; calibrated instrumentation, appropriate equipment, trained personnel, condition of test equipment and the item to be tested, suitable environmental conditions and provisions for data acquisition. In lieu of specially prepared written test procedures, appropriate sections of related documents, such as ASTM methods, standards of PSNE and/or supplier, equipment maintenance instructions, or travelers with acceptance criteria, may be used. Such documents include adequate instructions to assure the required quality of work. (3) The responsible Engineering/Design organization or the line-QA/QC organization, PSNE normally develops test procedures for items manufactured by PSNE. Test procedures for field electrical tests are developed by the Electrical Test staff of the Field Engineering Organization. (4) Product test results are documented, and evaluated by the responsible Engineering/Design or the line-QA/QC personnel to assure that test requirements have been satisfied. TOSHIBA 1/3

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QA PROGRAM DESCRIPTION Chapter 12 Test Control 4401-4 Ch-12 Rev.3 12.3 Preoperational Test (1) Preoperational test instructions are developed and provided to the owner of PSNE -supplied items. The Preoperational & start-up test staff (hereinafter "PST staff') in the Field Engineering Organization is responsible to establish the preoperational test instructions that incorporate or make reference to the requirements and acceptance criteria contained in applicable design documents. The preoperational test instructions include or reference test objectives and the provisions specified in para. 12.2 (2). (2) PSNE dispatches the PST staff and technical specialists who have enough product knowledge and preoperational testing experience for technical direction to support the preoperational test. (refer to Appendix 1 of this QA Program Description, PSNE position to Regulatory Guide 1.8 "Qualification and Training of Personnel for Nuclear Power Plants") PSNE supplies support documentation of the preoperational test results and its evaluation to the owner, when required by the contract. 12.4 Start-up Test (1) The owner performs initial fuel loading and nuclear system start-up tests. Start-up test instructions are developed and provided to the owner for PSNE -supplied items. The PST staff is responsible to establish the start-up test instructions that incorporate or make reference to the requirements and acceptance criteria contained in the applicable design documents. The start-up test instructions include or make reference to test objectives, provisions specified in para.12.2 (2), operational steps necessary to perform the test, and data sheets for documentation of the test conditions and results. (2) PSNE dispatches the PST staff and technical specialists who have enough product knowledge and start-up testing experience for technical direction to support the start-up test. (refer to Appendix 1 of this QA Program Description, PSNE position to Regulatory Guide 1.8 "Qualification and Training of Personnel for Nuclear Power Plants") PSNE supplies support documentation of the start-up test results and analysis and evaluation to the owner, when required by the contract. 12.5 Test Records Test records include, as a minimum, (1) through (8) below; (1) Item tested (2) Date of test TOSHIBA 2/3

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QA PROGRAM DESCRIPTION Chapter 12 Test Control 4401-4 Ch-12 Rev.3 (3) Tester or data recorder (4) Type of observation (5) Results and acceptability (6) Action taken in connection with any deviations noted (7) Person evaluating test results (8) Applicable test procedure number and its revision number TOSHIBA 3/3

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QA PROGRAM DESCRIPTION Chapter 13 Control of Measuring and Test Equipment 4401-4 Ch-13 Rev.2

13. Control of Measurin2 and Test Equipment 13.1 General Measuring and test equipment are controlled in accordance with the established control program, which constitute a part of the QA System of the relevant organizational unit of PSNE.

The Program provides assurance that tools, gages, instruments and other measuring and testing devices used in activities affecting quality are properly controlled, calibrated and adjusted at specified periods to maintain accuracy within necessary limits. 13.2 Selection Selection of measuring and test equipment is controlled to assure that equipments are of proper type, range, accuracy, and tolerance to accomplish the function of determining conformance to specified requirements. The selection is specified in inspection procedures/instructions, test procedures/instructions or other engineering/QC documents, or is under control of responsible management of the organization using the measuring and test equipment. 13.3 Control of measuring and test equipment The following measuring and test equipment controls are established in the QA Systems of the respective organizational unit of PSNE. (1) All measuring and test equipments subject to control are calibrated, adjusted and maintained at prescribed intervals or prior to use. A responsible organization (hereinafter referred to as "calibration control groups") is assigned to establish and maintain the Calibration Master List (or equivalent computer data base) which identifies all measuring and test equipment to be controlled, including a unique ID number and due date for calibration. The frequency and methods of calibration are specified and documented as a part of the QA System, based on the Code requirements, the type of equipment, stability characteristics, required accuracy, intended use and other conditions affecting measurement control. Calibration and adjustment may be performed in accordance with the manufacturer's instruction manual, when such a manual exists. (2) Line-QA/QC Organization is responsible to assure that adequate measuring and test equipments are utilized in activities affecting quality. TOSHIBA 1/2

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GA PROGRAM DESCRIPTION Chapter 13 Control of Measuring and Test Equipment 4401 -4 Ch-13 Rev. 2 (3) The calibration room utilizes master standards having the known valid relationships to nationally recognized standards for performing the calibration and adjustment. If no nationally recognized standards exist, the basis for calibration is documented. When there is no calibration facility, calibration of measuring and test equipment is subcontracted to a qualified vendor. The calibration and adjustment is recorded including the unique ID number of the measuring and test equipment as well as that of the master standards used for calibration, the date calibrated, the "as found" condition and calibrated results of the measuring and test equipment by person performing the calibration. The records are maintained in a prescribed manner. (4) Upon satisfactory completion of calibration, the calibrated measuring and test equipment are suitably marked to indicate calibration status. (5) When measuring and test equipment is found to be out of calibration, an evaluation is made and documented pertaining to the validity of previous inspection or test results and of the acceptability of the item previously inspected or tested. Out-of-calibration devices are tagged or segregated and not used until they have been recalibrated. If any measuring or test equipment is consistently found to be out of calibration, repair work or replacement is required. A calibration is performed when the accuracy of the equipment is suspected. (6) Commercial Devices Calibration and control may not be required for rulers, tape measures, levels, and other such device, when their use is limited to rough measuring functions. (7) Handling and Storage Measuring and test equipments are issued under controlled conditions by the calibration control groups. When measuring and test equipment are returned, their conditions are checked. The calibration control groups are responsible for storage and maintenance of the measuring and test equipment. TOSHIBA 2/2

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QA PROGRAM DESCRIPTION Chapter 14. Handling, Storage and Shipping 4401-4 Ch-14 Rev.2

14. Handling, Storage and Shiming 14.1 General (1) Procedures and practices are established and documented which provide control for handling, storage, shipping, cleaning and preservation of materials and equipment in accordance with the applicable Codes, Standards, Regulations and other technical requirements to prevent damage or deterioration.

(2) The control measures and responsibilities are documented in QA System of each organizational unit, PSNE. 14.2,General Specification (1) When required by the customer (owner), the Project Organizations establishes and issues a project requirement document for marking and labeling for packaging and shipping applied to all items supplied for the plant (project). The marking and labeling specification indicates the presence of special environment, if any, or the need for special control and a description of the information to be marked and labeled for packaging and shipping based on the contractual requirements. (2) The Engineering/Design Organization, NED issues specifications, when necessary, which include technical requirements to be applied for handling, storage and cleaning to prevent damage or deterioration. For critical, sensitive, perishable or high-value articles, specific procedures for the above activities are prepared and issued. 14.3 Control at Shop Organization and the Site The following control measures are established in the QA System of Shop Organization and the site. The Shop Organization and site are responsible for handling, storage, shipping, cleaning and preservation of items as applicable in accordance with their own QA System. (1) Instruction The Manufacturing, Shop Organization and the designated group for the site are responsible for establishing work and inspection instructions, drawings, shipment instructions and other pertinent documents or procedures specified for use in compliance with the specifications issued by the Project Organizations and/or Engineering/Design Organization, NED. TOSHIBA 1/2

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QA PROGRAM DESCRIPTION Chapter 14 Handling, Storage and Shipping 4401-4 Ch-14 Rev.2 For critical, sensitive, perishable, or high-value articles, specific procedures for handling, storage, packaging, shipping and preservation are prepared and used. (2) Tools and Equipment Special handling tools and equipment are utilized and controlled as necessary to ensure safe and adequate handling. The Manufacturing, Shop Organization and the designated group for the site are responsible for using inspection and test equipment and other special handling tools in accordance with established procedures. (3) Operators Operators of special handling and lifting equipment are experienced or trained in the use of the equipment. (4) Marking Instructions for marking and labeling for packaging, shipment, handling and storage of items are established as necessary to adequately identify, maintain and preserve items, including the presence of special environment or the need for special control. These instructions include or make reference to the general specification issued by the Project Organizations. TOSHIBA 2/2

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QA PROGRAM DESCRIPTION Chapter 15 Inspection, Test, and Operating Status 4401-4 Ch-15 Rev.1

15. Inspection, Test, and Operating Status 15.1 General Procedures and practices are established and documented to indicate the status of inspections and tests performed on individual items.

The measures are documented in the QA System of the respective organizational unit, PSNE. 15.2 Inspection, Test, and Operating Status Measures are provided for identification of inspection and test status in documents such as Shop Travelers and Process Control Sheets which are traceable to the items to assure that required inspections and tests are performed and that those items accepted by the required inspections and tests are used in manufacturing, released for shipment, installation, erection and serviced for operation. Nonconforming items are segregated, identified, as applicable, and controlled in accordance with Chapter 16 of this QA Program Description. The line-QA/QC organization reviews Shop Travelers and/or Process Control Sheets prior to shipment or release to the customer (owner) to assure that required inspections and tests have been performed and that unacceptable items are not inadvertently installed, used or serviced for operation. TOSHIBA 1 / I

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QA PROGRAM DESCRIPTION Chapter 16 Nonconforming Materials, Parts, or Components 4401-4 Ch-16 Rev.2

16. Nonconformin2 Materials, Parts, or Components 16.1 General (1) Procedures and practices are established and documented to provide for control of items which do not conform to specified requirements in order to prevent their inadvertent use or installation.

Control measures are documented in the QA System of the respective organizational unit of PSNE to provide for identification, documentation, evaluation, segregation, disposition of such items, and for notification to affected organizations. These procedures also delineate the responsibility and authority for evaluating and determining disposition of nonconformances. (2) Procured items that do not meet PSNE procurement document requirements are controlled per par. 8.8 of this QA Program Description. 16.2 Control of nonconforming items The following control measures for nonconforming items are established and documented in the QA Systems of organizational units PSNE. The respective organizational units, PSNE are responsible for controlling nonconforming items in accordance with their QA System. 16.2.1 Identification Nonconforming items are identified with marking, tagging or other methods that do not adversely affect the end use of the items. The identification is legible and easily recognizable. If identification of each nonconforming item is not practical, the container, package or segregated storage area, as appropriate, is identified. 16.2.2 Segregation Nonconforming items are segregated, when practical, by placing them in a clearly identified and designated hold area until proper disposition has been made. When segregation is impractical or impossible due to physical conditions such as size, weight or access limitations, other precautions are employed to preclude their inadvertent use. TOSHIBA 1/3

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QA PROGRAM DESCRIPTION Chapter 16 Nonconforming Materials, Parts, or Components 4401-4 Ch-16 Rev.2 16.2.3 Disposition (1) Responsibility and Authority Nonconforming characteristics are documented in the nonconformance report for review. The line-QA/QC organization designates a responsible organization, PSNE, or convenes a review board with the participation of responsible organizations, PSNE for evaluation and establishment of a disposition. The person in the responsible organization who is assigned for the evaluation of nonconformances have the demonstrated competence in the specific area he evaluates, adequate understanding of the requirements, and has an access to pertinent background information. Further processing, delivery, installation or use of nonconforming items are controlled pending an evaluation and approval of disposition by the line-QA/QC organization of PSNE. (2) Disposition The disposition of nonconforming items, such as use-as-is, reject, repair or rework, is identified and documented in the nonconformance report. When disposition of nonconforming items is use-as-is or repair, the technical justification is required by the Engineering/Design organization, PSNE, and documented. Nonconformances to design requirement disposed of as "use-as-is" or "repair", are subject to design control measures commensurate with those applied to the original design. When required in the contract or by the Code, the nonconformance report is forwarded to the customer (Owner) for his acceptance. Upon approval of the disposition, the nonconformance report is forwarded to the organization that implements the disposition, and to other organizations responsible for activities that are affected by the disposition. A completed nonconformance report identifies the nonconforming

item, description of nonconformance, the disposition made, technical justification for acceptability, approval signature of the disposition, repair procedure, if applicable, and documents to be revised (if applicable).

The nonconformance is evaluated to determine whether corrective action is necessary (control measures for the corrective action are described in Chapter 17 of this QA Program Description). The as-built records reflect the accepted deviation, if such records are required. TOSHIBA 2/3

GA 7'13 AYi' U'J-'. r >a 16 9U%, Mg 4401-4 Ch-16 Rev.2 (3) Mf It, fl*tO No2c 3/3

QA PROGRAM DESCRIPTION Chapter 16 Nonconforming Materials1 Parts, or Components 4401-4 Ch-16 Rev.2 (3) Repaired or Reworked Items When disposition of nonconforming items is "rework" or "repair", the items are reexamined in accordance with the applicable specification/procedure/instruction and with the original acceptance criteria unless otherwise specified. TOSHIBA 3/3

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17. U 17.1 -i*

IMIA,~J TMM MfJ AR jE. ]7--7,y7° 1-z :, PSNE O QA T°]"L' 17.2 MET] Z.I W- 0 )5 M ~ (i~ij)QAPSNPSNE GDQAfROD QA IASFl IL,ý l-5o 11'35t W*:{**@(17.2.1 WPJRZý 17.2.3 MO) b) PSNEP* 0U, QA6.

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QA PROGRAM DESCRIPTION Chapter 17 Corrective Action 4401-4 Ch-17 Rev.2

17. Corrective Action 17.1 General Procedures and practices are established and documented to provide assurance that conditions adverse to quality, such as failures, malfunctions, deficiencies, deviations, defective materials and equipment, and nonconformances are promptly identified and corrected.

For significant conditions adverse to quality, measures are taken to assure that the cause of the condition is determined and corrective action taken to preclude recurrence. These measures are established in the QA Program, PSNE to provide identification, documentation, classification, cause analysis, reporting to appropriate levels of management, corrections of adverse conditions and their follow-up. 1 17.2 Measures for Corrective Action The following measures for corrective action are established and documented in the QA System of the organizational units, PSNE. The designated organizations and personnel (See para.17.2.1 and 17.2.3) are responsible for identification, documentation, classification, cause analysis and correction of adverse conditions within their respective areas of responsibility. NQA as the key QA organization, PSNE has overall responsibility to assure that corrective actions are taken to rectify conditions adverse to quality and to preclude recurrence. 17.2.1 Identification and Documentation (1) Conditions adverse to quality are identified and documented in the following documents: (a) Vendor's nonconformance report (See para.8.8) (b) Nonconformance report, PSNE (See para. 16.2) (c) External audit reports (See para.19.2) (d) Internal audit reports (See para. 19.1) Other information, such as external organization's audit results and adverse trends, are reviewed to determine if they imply conditions adverse to quality. (2) When such conditions are identified, the extent to which other items and activities may be affected is evaluated. Conditions adverse to quality are reviewed to determine the presence of trends and whether it is the first occurrence or recurrence. In addition to the review(s) mentioned above, the QA Staff Organizations, PSNE reviews the documented conditions that may be adverse to quality including results of external organization's audit to provide for the management reviews. TOSHIBA 1/3

QA -)'13Y 5L 5ý-,7U$.'J M 17 lE 4401-4 Ch-17 Rev.2 17.2.2 $il (1) ID, -0,17.2.1 "'A t3 -C6 J (a) MgN OD _3 f@ ýb 7.) M JR MI' (d) *o+/-'1I (C) {-/R A L7 T ý- 0 w Vfl (d) TF ROD @f (e) T 4 'k!_ l 0 R 9-ý-*, f IfT _( t / v:P4 ,-W (b)~ 17.2.3 frN* {U*T W, ]a f f ,C5 E 3 II*]- L ~T ir (3)~~~ 7O 1-Z-' ýg 4 t4ýR 4: At, C :t 2/3

QA PROGRAM DESCRIPTION Chapter 17 Corrective Action 4401-4 Ch-17 Rev.2 17.2.2 Classification (1) The conditions adverse to quality identified in paragraph 17.2.1 are classified to determine whether further action is necessary. Criteria for classifying conditions adverse to quality consider the following aspects: (a) Impact on health and safety of the public or environment; (b) Impact on reliability, availability, or maintainability of the equipment or facility; (c) Importance in meeting regulatory requirements; (d) Consequence of recurrence (e) The extent to which the adverse condition may apply to other items or activities beyond the specific occurrence where it may have greater impact. (2) Conditions adverse to quality identified under (1) above are classified according to significance using the following criteria. (a) Deficiencies in design, manufacturing, construction, testing or process requiring substantial rework, repair or replacement; (b) Damage to structure, system component or facility requiring substantial repair (c) A non-conservative error detected in a computer program after it has been released for use; (d) Loss of essential data; (e) Repeated failure to implement a portion of an approved procedure-, (f) Deficiencies in documentation or procedures that render an activity unacceptable or indeterminate. (3) In classifying conditions adverse to quality, the review considers repetition of specific conditions adverse to quality, as well as the relationship or similarity between different conditions, in a manner and at a frequency that assures significant quality trends are identified and evaluated for appropriate correction. 17.2.3 Cause Analysis and Correction The action(s) necessary to correct conditions adverse to quality is determined and implemented. For significant conditions adverse to quality, the root cause is determined and documented, and the impact of such conditions on completed and/or related items and activities are evaluated. This step includes the evaluation to determine whether the nonconformance condition is reportable in accordance with IOCFR21 (refer to "Reporting Procedure for Defects and Noncompliance under NRCIOCFR21 (PSNE R&P 4810)"). Corrective action report and request forms are used to document the cause, preventive measures, response and implementation of corrective actions including follow-up. The QA Staff Organization is responsible for monitoring the status of corrective TOSHIBA 2/3

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QA PROGRAM DESCRIPTION Chapter 17 Corrective Action 4401-4 Ch-17 Rev.2 action progress to completion. 17.2.4 Follow-up (1) Implementation of corrective actions, including actions to prevent recurrence is verified and assessed to determine its effectiveness. (2) Corrective actions taken and documented are verified by the organization and personnel who initiated these actions as complete only when the actions have been taken and documented. When completion of corrective actions cannot be verified due to a delay for an extended period of time, notification of the delay is made to management of the affected organizations. (3) After verification of corrective actions has been made as complete, the follow-up review or audit is performed to determine whether actions taken have been and continue to be effective. TOSHIBA 3/3

QA -/r y A 7- -'fA 7-018-4401-4 Ch-18 Rev.3

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QA PROGRAM DESCRIPTION Chapter 18 Quality Assurance Records 4401-4 Ch-18 Rev.3

18. Ouality Assurance Records 18.1 Records Control 18.1.1 Records System and Generation (1) Records generated by PSNE for the specific plant (project)

At the earliest practicable time consistent with the schedule for accomplishing work activities, NQA is responsible for establishing a procedure for generation, identification, storage and disposition of QA records for the specific plant (project). The QA Record Control Procedure includes or specifies procedure to establish a list that identifies, as a minimum, records to be generated, record retention period and the location. The QA Record Control Procedure provides control for a specific plant (project) records. (2) Programmatic records Procedures and/or standards are established and documented within the respective organizational unit of PSNE for control of programmatic records. (3) Records generated by vendors QA records for purchased materials, equipment and services are generated by vendors. The applicable procurement documents specify QA records to be generated, submitted or maintained. Vendor QA record list includes, as a minimum, records to be generated, record retention period and location of records and is submitted to PSNE by the vendors, when required by procurement documents. Necessary information in the vendor QA record lists is included in the QA record list established for the specific plant (project) (18. 1. 1 (1)). (4) QA records to be submitted to the customer (owner) (or to be retained in PSNE) are specified in the QA Record Control Procedure in compliance with the contractual requirements. NQA is responsible for transmittal of QA records to the customer (owner). (5) Documents that are designated to become QA records are legible, accurate and complete appropriate to the work accomplished. Inspection and Test records identify, as a minimum, the inspector or data recorder, the type of observation, results and acceptability of inspections and tests, and the action taken in connection with any deficiencies noted. 18.1.2 Record Validation Documents are considered valid records only when they are stamped, initialed or signed and dated by the authorized personnel or otherwise authenticated. QA and QC Organization PSNE are responsible for the validation of QA records. The TOSHIBA 1/7

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QA PROGRAM DESCRIPTION Chapter 18 Quality Assurance Records 4401-4 Ch-18 Rev.3 authentication may take the form of a statement. Handwritten signatures are not required if the document is clearly identified as a statement by the reporting individual or organization. These records may be either the originals or reproduced copies. 18.1.3 Index and Identification QA records are indexed by record numbers on the QA Record List. All QA records to be stored in PSNE (including incoming QA records) are identified by record number for control and storage. The record number index includes such information as plant (project)

name, document

title, customer's

name, system/equipment name, etc.

18.1.4 Classification and Retention of Records The QA records are classified into Lifetime or Nonpermanent. Programmatic nonpermanent records are retained for at least 3 years and product nonpermanent records are retained for at least 10 years or the life of the item if it is less than 10 years. For programmatic nonpen-nanent records, the retention period is considered to begin upon completion of the activity. For product nonpermanent records generated before commercial operation begins, the retention period is considered to begin upon completion of delivery. The attached table in this Chapter provides a list of nonpermanent and lifetime records and their respective retention periods. 18.1.5 Corrected information in Records QA records may be corrected by the person who generated the originals, or who is responsible for the organization which generates the originals. The correction includes the data and the identification of the person who made such correction. 18.2 Receipt and Storage (1) Those documents that are designated to be QA records including in-coming records are sent (or submitted) to the designated QA or QC organizations. After checking the legibility, accuracy and completeness of these documents, the valid QA records are transferred to the storage facility. The QA records are placed under a method for maintaining control and accountability for records when removed from the storage facility; a method for filing supplemental information and disposing superseded records. TOSHIBA 2/7

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4401-4 Ch-18 Rev.3 (2) JP4K < L t -VEO©(a)71 6( PSNE-ýf,,I7) (a) V (g) k-D-- (a)IR ýAý 7"' ý, 4" OD" Tý 1-99,k TG 5194,T 1-99 / T2-9R, ASME NQA-1 Supplement 17S-1 4.40)-T;Q{MCJi; F-oIfrfl Fft~t: RT 71 A 4z ~7 V4 L/~ IN~ 0) ~L~Oi~fi~T~ThPSNEU, RJS-2OOO-18, R13It; NIRMA }f I <ýi 2 TQ11-1998, TG15-1998, TG16-1998 R TG21-1998tM U:IRf4-AW 1 3/7

QA PROGRAM DESCRIPTION Chapter 18 Quality Assurance Records 4401-4 Ch-18 Rev. 3 (2) Written Storage Procedures/Standards are established in the QA System of each organizational unit PSNE, which include, as a minimum, (a) through (g) below; (a) description of the storage facility; (b) filing system to be used; (c) method of verifying that the records received are in agreement with the transmittal document and that the records are legible; (d) method of verifying that the records are those designated; (e) rules pertaining to access limitation and control of files; (f) method of maintaining control of and accountability for records removed from the storage facility; (g) method of filing supplemental information and disposition of superseded records. (3) Only authorized personnel can access the storage facilities for QA records. Personnel who want to access the QA records request to the authorized personnel. (4) The QA records are stored in storage facilities constructed and maintained in a manner which minimizes the risk of damage or destruction from the following; (a) natural disaster such as wind, flood or fire; (b) environmental conditions such as high and low temperatures and humidity; (c) infestation of insects, mold, or rodents. Storage facilities of PSNE for safety-related QA records as a minimum, meet the requirements of ASME NQA-1 Supplement 17S-1 4.4 Storage Facilities that allow "Single Storage Facility", "Alternate Single Storage Facility", or "Dual Storage Facilities". The Storage Procedure/Standard within each organizational unit, PSNE specifies the application method of storage facilities. Records of special processes, such as radiographs, microfilm and magnetic media are stored in such a manner to prevent damage from excessive light, stacking and electromagnetic fields in addition to the temperature and humidity control. When applicable, PSNE manage the storage of QA records in electronic media consistent with the intent of RIS-2000-18 and associated NIRMA Guidelines TG1l-1998, TG15-1998, TG16-1998, and TG21-1998. TOSHIBA 3/7

QA ir2y i 7- -f-A 9j 18i& B: 'E 4401-4 Ch-18 Rev.3 18.3 1tt. 18.4 (1) n© .*.hQJ A S M E=- ©)4>,5* -3 7 0T) IJ FP (2) ýt (3) 4.-o < L t X M §52.103(g) t bti#_ * *C*, ft 2hLJR.*-9 (4) RU%* (5) JA A: (/t - -ý---) 0) 5?

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QA PROGRAM DESCRIPTION Chapter 18 Quality Assurance Records 4401-4 Ch-18 Rev..3 (5) When temporary storage of the safety-related QA records (such as for processing, review, or use) is required, such QA records are stored in 1 hour fire rated container to prevent loss, damage and deterioration. 18.3 Retrieval When QA records are brought out from the records storage rooms, the name of a person who brought out, date, QA records No. are recorded. If these QA records are not returned by the due date, the authorized individual contact the person and request to return. QA records in storage are periodically checked to verify whether damages on the records are exist or not. Damaged QA records are reinstated by the responsible organization PSNE. The customer (owner), regulatory representative and ASME Authorized Nuclear Inspector have a right of access to the records retained. 18.4 Disposition Various regulatory agencies have requirements concerning QA records. The most stringent requirements are employed in determining the final disposition. The non-permanent QA records are not disposed of until the applicable conditions listed (1) through (5) below are satisfied. (1) items are released for shipment, ASME Code Manufacturer's Data Report is signed, or Code Symbol Stamp is affixed; (2) regulatory requirements are satisfied; (3) nonpermanent records are retained at least until the date on which the Commission makes a finding that acceptance criteria are met under § 52.103(g); (4) warranty condition is satisfied; and, (5) customer's (owner's) requirements are satisfied. TOSHIBA 4/7

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QA PROGRAM DESCRIPTION Chapter 18 Quality Assurance Records 4401-4 Ch-18 Rev.3 RETENTION TIMES FOR QA RECORDS(Safety related activities & ASME Code) Record Type Retention Time

1 Desgn Record Applicable Codes & Standards used in Design L

Design Drawings (As-Constructed) L Design Calculations & Record of Checks (Design Verification) L Design Change Notices L Design Deviations (Nonconformance Reports) L Design Reports L Design verification Reports L Design Specifications & Amendments (Certified Design Specifications - ASME Code item) L Safety Analysis Report L Stress Reports (Certified Stress Reports - ASME Code item) L General Design Documents L Systems Design Documents L Equipment Requirement Specifications L Technical Analysis, Evaluations, and Reports (Topical Reports) L Reliability analysis, evaluation, and reports L Equipment qualification documentation L Design Review Meeting Reports 10 Engineering & Design Procedures, Manuals and supporting procedures 3 Reports of engineering surveillance of field activity 3 PSNE-Approved Vendor Drawings and Procedures L NDE Specifications 3 2 Preocuriemhnt Records (Pro6ured item),; Procurement Documents L Purchase Order (un-priced) including Amendments L Procurement Procedures 3 Purchaser's (PSNE) Pre-Award QA Survey 3 In-coming QA Records (Binder) L Vendor's QA Program Manual V Annual assessment reports, Audit Reports, Plan 3 Certificate of Compliance, Product Quality Certification, Code Data Reports L Sourcing verification report, Receiving inspection report 3 3 Mand acturing Riecords.(PSNE Make). As-Built Drawings and Records (Outline Drawings, Parts and Assembly Drawings) L Certificates of Compliance, Product Quality Certification, Code Data Reports L Eddy-Current Examination Final Results L Electrical Control Verification Test Results L Ferrite Test Results L Heat Treatment Records L Liquid Penetrant Examination Final Results L Weld Joint Location Diagrams L Welding Filler Metal Material Reports L Weld Fit-up Records L Magnetic Particle Examination Final Results L Major Defect Repair Records L Materials Properties Records L Nonconformance Reports L Performance Test Procedure & Results Records L Pipe and Fitting Location Records L TOSHIBA 5/7

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QA PROGRAM DESCRIPTION Chapter 18 Quality Assurance Records 44131 -4 F'l"t-1 R 1* 4401-4 Ch-1A Rev I RETENTION TIMES FOR QA RECORDS(Safety related activities & ASME Code) Record Type Retention Time Pressure Test Results L Radiographic Review Records L Ultrasonic Examination Final Results L Welding Procedures L Radiographs not required by ASME Section XA 10 Certificate of Inspection & Test Personnel & Qualification 3 Cleaning Procedures 3 Eddy-Current Examination Procedures 3 Ferrite Test Procedures 3 Forming & Bending Procedure Qualifications 3 Heat Treatment Procedures 3 Hot Bending Procedure 3 Insp. & Test Instrumentation & Tooling Calibration Procedures & Records 3 Liquid Penetrant Examination Procedure 3 Magnetic Particle Examination Procedure 3 Packaging, Receiving, and Storage Procedures 3 Product Equipment Calibration Procedure 3 QA Manuals, Procedures, Standards & Instructions 3 Radiographic Procedures 3 Ultrasonic Examination Procedures 3 Welding Materials Control Procedures 3 Welding Procedure Qualifications and Data Reports 10 Process Sheets, Sequencing Documents, and Travellers L Calibration Records for measuring and test equipment C Special tool calibration records C In-Process (Final) Inspection & Test Results L Pressure Test Procedure 3 Welding Personnel Qualification 3 Receiving Inspection Records L 4.1nstallation, Construction Records.(PSNE Make) .4.1 Wetldng Ferrite test results L Heat treatment records L Liquid penetrant test final results L Material property records L Magnetic particle test final results L Major weld repair procedure and results L Radiograph review records and final results L Ultrasonic test final results L Weld Joint Location Diagrams L Weld procedures L Welding filler metal material reports L Ferrite test procedures 3 Heat treatment procedures 3 Liquid penetrant test procedures 3 Magnetic particle test procedures 3 Radiographic test procedures 3 Ultrasonic test procedures 3 Welding materials control procedures 3 Welding personnel qualifications 3 TOSHIBA 6/7

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QA PROGRAM DESCRIPTION Chapter 18 Quality Assurance Records 4401-4 Ch-18 Rev.3 RETENTION TIMES FOR QA RECORDS(Safety related activities & ASME Code) Record Type Retention Time Weld fit-up Records 10 Weld procedure qualifications and results 10 .4.2 miK. Cleaning procedures and results L Installed lifting and handling equipment procedures, inspection, and test data L Lubrication procedures L Material properties records L Pipe and fitting location Records L Piping & Equipments Support Records L Safety valve response test procedures L Code data reports L Pressure test results (hydrostatic or pneumatic) 3 Chemical composition user's test (grab samples) for thermal insulation 10 Material property test reports for thermal insulation 10 Safety valve response test results 10 Cleaning procedures 3 Construction lifting and handling equipment test procedures 3 Erection procedures for mechanical components 3 Hydro-test procedures .3 Al.General As-built drawings and records L Final inspection reports and releases L Nonconformance reports L Specifications and drawings L Index system to record file L Field quality assurance manuals 3 Quality Control Plan 3 Audit Reports, Plan 3 Calibration records for measuring and test equipment C Calibration procedures for measuring and test equipment and instruments 3 Special tool calibration records C Certificate of inspection and test personnel qualification 3 5i-Preoperational and StartupTest Records. I I Operation and Maintenance Manuals L Pre-operation Test Instructions L Startup Test Instructions L Remarks Where PSNE supplies QA records to the Customer (Owner), PSNE will normally retain copies as needed for PSNE business purposes, not for regulatory/Code requirements. For programmatic nonpermanent records, the retention period should be considered to begin upon completion of the activities. For product nonpermanent records generated before commercial operation begins, the retention period should be considered to begin upon completion of delivery. In addition, product & programmatic nonpermanent records should be retained at least until the date of issuance of the full-power operating license of the plant(project). L: Lifetime retention (life of the item) 3: 3 years retention (from date of generation) 10: 10 years retention (from date of generation) C: Retained until re-calibrated V: Retained until purchase order is close out TOSHIBA 7/7

m19 IV R4401-4 Ch-19 Rev.3 19. 19.1 -J Q, =L 19.2 *{ U)2Lr$2'--

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QA PROGRAM DESCRIPTION Chapter 19 Audits 4401-4 Ch-19 Rev.3

19. Audits 19.1 General A comprehensive system of planned and periodic audits is carried out to verify compliance with all aspects of QA Program and to determine the effectiveness of the Program.

Additional audits may be conducted on an unscheduled basis. PSNE procedures require that QA audits be conducted using pre-established Audit Checklists by appropriately trained personnel not having direct responsibilities in the areas to be audited. Audit results are documented by the auditor and reviewed by management having responsibility in the area audited. The audit program provides for follow-up action, including re-audit of deficient areas, to assure that corrective action and/or disposition for findings have been taken. Audits are performed to determine the following, as appropriate: (1) Adequacy of documented QA-related policies, procedures, and instructions for their intended purpose of assuring product quality. (2) Compliance with applicable Codes, Standards, Regulations, quality-related policies, procedures and instructions. (3) Adequacy of work areas, activities, processes, equipment, documents and records. (4) Implementation of corrective action in accordance with applicable procedures. 19.2 Responsibility and Scheduling (1) The QA Staff Organizations are responsible for establishing, maintaining and implementing the QA program, including performance of internal audits within their areas. The QA Staff Organizations conducts internal audits to Shop QA, Regional (Subsidiary) QA, and site QA organization for comprehensive evaluation of the QA Program, PSNE. Internal audits are performed at least once every year. Scheduled audits are documented to identify the organizations to be audited and audit dates. The documented audit schedules are reviewed within pre-determined periods, and revised where necessary. Audits may be conducted more frequently when judged necessary by TE or a respective QA Manager within PSNE. (2) PSNE vendors are subject to be evaluated as described in para.8.3. When a survey/audit is performed for the vendor evaluation, survey/audit schedules are documented and maintained in the same manner as described in (1) above including performance of additional audits. TOSHIBA 1/6

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QA PROGRAM DESCRIPTION Chapter 19 Audits 4401-4 Ch-19 Rev.3 19.3 Audit Plan The QA Staff Organizations are responsible for establishing a plan for the survey/audit (internal and external, as applicable) to identify the audit scope and requirements, auditors, activities and organizations to be audited, applicable documents, schedule and audit checklists. The audit scope is determined based on the evaluation of the activity to be audited. The evaluation includes results of previous QA Program audit/assessment and those from external sources. The evaluation also includes the nature and frequency of identified deficiencies and any significant changes in personnel, organization or QA Program. The survey/audit plan is established prior to the start of each audit. 19.4 Audit Personnel Qualified auditors are assigned, who are independent of any direct responsibility for the activities to be audited. Auditors are qualified in accordance with the method described in para. 19.11. 19.5 Selection of Audit Team An audit team is identified and documented. The audit team shall contain one or more auditors and shall have an individual appointed to lead the team. The lead auditor has the responsibility for the activities described in para. 19.6, and concurs that the assigned auditor(s) collectively has experience or training commensurate with the scope, complexity or special nature of the activities to be audited, where required. 19.6 Performance The lead auditor conducts the audit, and has the responsibility for the following. (1) Organizing and directing the audit. (2) Performing the audit in accordance with the Audit Checklist. Elements selected for the audit are required to be evaluated against specified requirements. The Audit Checklist provides space for recording objective evidence of documents and items reviewed during the audit to determine their acceptability. ObJ ective evidence is required to be examined to the depth necessary to determine if these elements are being implemented effectively. (3) Documenting the finding in a Survey/Audit Report. (4) Recording the evaluation of audit findings. (5) Recommending corrective actions. TOSHIBA 2/6

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QA PROGRAM DESCRIPTION Chapter 19 Audits 4401-4 Ch-19 Rev.3 (6) Making recommendations to the responsible QA organization for proposed changes to the QA program, if necessary. (7) Conducting the follow-up action, to verify completion of the corrective action. (8) Issuance of the Survey/Audit Report (refer to para. 19.7). (9) Reviewing of the previous audit findings prior to performing the audit. 19.7 Reporting The lead auditor prepares the Survey/Audit Report, which includes the following information; (1) Organization audited. (2) Description of the audit scope. (3) Audit date. (4) Identification of auditors. (5) Identification of persons contacted during audit activities. (6) Summary of audit results, including a statement on the effectiveness of QA Program for elements that were audited. (7) Description of reported adverse audit findings in sufficient detail to enable corrective action and/or disposition to be taken and required reply date by the organization audited. The corrective action, if required, is taken as described in Chapter 17. The Survey/Audit Report is signed/stamped by the lead auditor and is forwarded to the responsible management personnel of the organization audited for his review. 19.8 Response The responsible management of the organization audited is required to investigate adverse audit findings and to schedule corrective action including measures to prevent recurrence, if necessary. Disposition of findings is described in the Survey/Audit Report and notified to the lead auditor by the required reply date. Audit response is verified by the lead auditor and forwarded to the responsible QA Staff Organization. 19.9 Follow-up Action The lead auditor is required to conduct the follow-up to verify that corrective action and/or disposition has been taken as scheduled. The results of the follow-up are described in the Survey/Audit Report. TOSHIBA 3/6

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19. 10 Record Maintenance The QA Staff Organization maintains QA audit documents including Survey/Audit Plans, Survey/Audit Reports, and the record of corrective action taken.

19.11 Qualification of QAAudit Personnel QA audit personnel are trained, examined and qualified in accordance with the PSNE Quality System documents. The QA Staff Organizations are responsible for the followings. (1) Conducting the specified training and/or examination for the prospective lead auditors and auditors of each organizational unit of PSNE. (2) Approval of qualification and certification of lead auditors and auditors. (3) Periodical evaluation of lead auditors. (4) Lead auditors and auditors for safety-related activities are qualified in accordance with ASME NQA-I 2S-3, and evaluated on an annual basis. 19.11.1 Qualification of Auditors A prospective auditor is qualified as an auditor by the Manager of the respective QA Staff Organization after satisfactory completion of the followings. (1) Indoctrination/Training Indoctrination and training in the following areas are given. (a) Working knowledge and understanding of Regulatory requirements, Codes, Standards, applicable elements of PSNE QA Program and audit procedures. (b) Fundamentals, objectives, characteristics, organizations, performance and results of quality auditing. (c) Auditing techniques of examining, questioning, evaluating, documenting specific audit items, and closing out auditing findings. (2) Evaluation of education and experience The prospective auditor is required to have enough educational and work experience to be qualified as an auditor. The evaluation for auditors for safety-related activities is performed by a scoring system in accordance with the PSNE procedures. 19.11.2 Qualification of Lead Auditors A prospective lead auditor is qualified as a lead auditor by the Manager of the respective QA Staff Organization after satisfactory completion of the followings; (1) Indoctrination/Training Indoctrination and training on the following areas are given, in addition to the TOSHIBA 4/6

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QA PROGRAM DESCRIPTION Chapter 19 Audits 4401-4 Ch-19 Rev.3 areas described in para. 19. 11. 1. (a) Methods of identification and following up on items subject to corrective action. (b) Audit planning of the quality-related ftinctions for the following activities; design, purchasing, fabrication, handling, shipping, storage, cleaning, erection, installation, inspection & testing, statistics, nondestructive examination, maintenance, repair, operation, modification of nuclear facilities or associated components, and safety aspects of the nuclear facility. (2) Examination The prospective lead auditor for safety-related activities is required to pass the written examination, which evaluate his comprehension and ability to apply the knowledge identified in (1) above. (3) Audit participation (lead auditors for safety-related activities only) The prospective lead auditor has participated in, as an auditor, in a minimum of five (5) audits (internal and/or external survey/audit) within a period of time not to exceeding three (3) years prior to the date of qualification as a lead auditor, one audit of which is a nuclear audit within a year prior to qualification. These audit participation requirements are applied for prospective lead auditor for safety-related activities. (4) Communication skills The prospective lead auditor is required to be capable of communicating effectively both in writing and verbal means. These skills are attested by the Manager of the respective QA Staff Organization, where required. (5) Evaluation of education and experience The prospective lead auditor is required to have enough educational and work experience to qualify as a lead auditor. The evaluation for lead auditors for safety-related activities is performed by a scoring system in accordance with the PSNE procedures. 19.11.3 Maintenance of Qualification Proficiency is maintained by one or more of the followings; (1) Regular and active participation in the audit process, (2) Review and study of regulatory requirements, Codes, Standards, procedures, instructions or other documents related to the QA Programs and program auditing. (3) Participation, in training programs. The Manager of each QA Staff Organization assesses the lead auditor's/ auditor's TOSHIBA 5/6

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QA PROGRAM DESCRIPTION Chapter 19 Audits 4401-4 Ch-19 Rev.3 proficiency regularly and documents the results. When re-train or re-qualification of the lead auditor/ auditor is considered to be necessary, the Manager of the respective QA Staff Organization documents this on the auditor qualification record. The lead auditors who fail to maintain their proficiency for a period of 2 years or more require re-qualification. 19.11.4 Records Results of qualification and assessment of lead auditors and auditors are recorded on each Auditor Qualification Record. Auditor Qualification Records are maintained by the respective QA Staff Organization. TOSHIBA 6/6

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20. Non Safety-related SSC Quality Control 20.1 General Specific program controls are applied to those SSC&S that are not classified as safety-related, but support safe, economic, and reliable facility operations, or where other regulatory guidance establishes quality requirements.

The quality control measures are necessary to achieve the level of quality specified, and commensurate with the complexity and characteristic of the SSC&C, and safety and reliable functions they perform (Graded Quality Control). The specific program controls consistent with applicable sections of the QA Program Description are applied to those SSC&S in a selected manner as described in each section and clarified as follows. 20.2 Organization The verification activities described in this chapter may be performed by the PSNE line organization. The QA organization described in chapter 1 through 19 is not required to perform these functions. 20.3 QA Program (1) Para 3.2.2 lists the key QA program documents governing the safety-related activities. To support for the non safety-related SSC&S, Shop Organization PSNE may implement quality system consistent with ISo9001, as a minimum. It is noted that some non safety-related SSC have one or more selected but limited requirements that are specified to ensure acceptable performance of specific non safety-related functions. To supplement IS09001 program (or, replace parts of IS09001 program) for such SSC, element of 10CFR50 Appendix-B are generally applied commensurate with the specific function performed. Suppliers of the non safety-related SSC&S are required to have quality program, procedure and/or control commensurate with the type and scope of the procurement. A new or separate quality program is not required. (2) Qualification requirements for QA managers specified in para 3.4 (4) are not required to person responsible for non safety-related QA activities. TOSHIBA 1/5

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QA PROGRAM DESCRIPTION Chapter 20 Non Safety-related SSC Quality Control 4401-4 Ch-20 Rev.0 20.4 Design Control PSNE implement design control as specified in this QA Program Description, quality manuals and procedures, and complying with applicable regulation, code and standard for non safety-related SSC&S. These measures ensure that applicable design input are included or correctly translated into the design documents, and deviations from those requirements are controlled. Design verification may be provided through the normal supervisory review of designer's work, as described in para 4.5.2 of this QA Program Description. 20.5 Procurement Document Control Procurement documents for items and services obtained by or for PSNE include or reference documents describing applicable design bases, design requirements, quality requirements and other requirements necessary to ensure component performance. The procurement documents are controlled to address deviations from the specified requirements. 20.6 Instructions, Procedures and Drawings PSNE provide documents such as, but not limited to, written instructions, plant (project) procedures, drawings, vendor technical manuals, and special instructions in work orders, to direct the performance of activities affecting quality. The method of instruction employed provides an appropriate degree of guidance to the personnel performing the activity to achieve acceptable functional performance of the SSC. 20.7 Document Control PSNE establish and implement controls for the issuance and change of documents that specify quality requirements or prescribe activities affecting quality to ensure that correct documents are used. These controls include review and approval of documents, identification of the appropriate revision for use, and measures to preclude the use of superseded or obsolete documents. 20.8 Control of Purchased Items and Services PSNE establish and implement measures, such as inspection of items or documents upon receipt or acceptance testing, to ensure that all purchased items and services conform to appropriate procurement documents. TOSHIBA 2 /5

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QA PROGRAM DESCRIPTION Chapter 20 Non Safety-related SSC Quality Control 4401-4 Ch-20 Rev. 0 20.9 Identification and Control of Materials, Parts and Components PSNE implement identification and control of materials, parts, and components as specified in this QA Program Description, quality manuals and procedures, and complying with applicable regulation, code and standard for non safety-related SSC&S. 20.10 Control of Special Process PSNE establish and implement process and procedure controls for special processes, including welding, heat treating, and nondestructive testing. These controls are based on applicable codes, standards, specifications, criteria, or other special requirements for the special process. 20.11 Inspection PSNE establish documented instructions to ensure necessary inspections are performed to verify conformance of an item or activity to specified requirements or to verify that activities are satisfactorily accomplished. These inspections may be performed by personnel in the line organization through the process that utilizes knowledgeable personnel to perform the verification function. 20.12 Test control PSNE establish measures to identify required testing that demonstrates that equipment conforms to design requirements. These tests are performed in accordance with test instructions or procedures. The test results are recorded, and authorized individuals evaluate the results to ensure that test requirements are met. 20.13 Control of Measuring and Test Equipment (M&TE) PSNE establish and implement measures to control M&TE use, and calibration and adjustment at specific intervals or prior to use. 20.14 Handling, Storage and Shipping PSNE establish and implement measures to control the handling, storage, cleaning, packaging, shipping, and preservation of items to prevent damage or loss and to minimize deterioration. These measures include appropriate marking or labels, and identification of any special storage or handling requirements. TOSHIBA 3/5

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GA PROGRAM DESCRIPTION Chapter 20 Non Safety-related SSC Quality Control 4401-4 Ch-20 Rev. 0 20.15 Inspection, Test, and Operating Status PSNE establish and implement measures to identify items that have satisfactorily passed required tests and inspections and to indicate the status of inspection, test, and operability as appropriate. 20.16 Control of nonconforing Items PSNE establish and implement measures to identify and control items that do not conform to specified requirements to prevent their inadvertent installation or use. 20.17 Corrective Action PSNE establish and implement measures to ensure that failures, malfunctions, deficiencies, deviations, defective components, and nonconformances are properly identified, reported, and corrected. 20.18 Records PSNE establish and implement measures to ensure records are prepared and maintained to furnish evidence that the above requirements for design, procurement, document control, inspection, and test activities have been met. 20.19 Audit PSNE implement audit as specified in this QA Program Description, quality manuals and procedures for non safety-related SSC&S, to verify compliance with applicable portions of the QA program and to determine its effectiveness. Audit frequency for non safety-related activities is commensurate with the scope, complexity or special nature of the activities to be audited. TOSHIBA 4/5

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OA PROGRAM DESCRIPTION Chapter 20 Non Safety-related SSC Quality Control 44 01 - 4 Ch-2 0 Rev. 0 20.20 Non Safety-Related SSC Credited for Regulatory Events The following criteria applies to fire protection (10 CFR 50.48), anticipated transients without scram (ATWS) (10 CFR 50.62), the station blackout (SBO) (10 CFR 50.63) SSC&S that are not safety related. (1) PSNE implement quality requirements to the fire protection system in accordance with Regulatory Position 1.7, "Quality Assurance," in Regulatory Guide 1.189, "Fire Protection for Operating Nuclear Power Plants" to the extent necessary for PSNE supplied design, components, structures and systems. Administrative elements of the fire protection program, including the fire protection organization, are the responsibility of the operating license applicant. QA program for fire protection as applicable elements, such as design, is established and maintained as a part of QA program PSNE. (2) PSNE implement the quality requirements to ATWS equipment in accordance with Generic Letter 85-06, "Quality Assurance Guidance for ATWS Equipment That Is Not Safety Related." (3) PSNE implement quality requirements to SBO equipment in accordance with Regulatory Position 3.5, "Quality Assurance and Specific Guidance for SBO Equipment That Is Not Safety Related," and Appendix A, "Quality Assurance Guidance for Non-Safety Systems and Equipment," in Regulatory Guide 1.155, "Station Blackout." TOSHIBA 5/5

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-1 0 U) 5 7M Ln APPENDIX 1 NRC Reaulatorv Positions (1) PSNE Positions on US NRC Regulatory Guides NRC Regulatory Guides Referencing Standards PSNE Position Regulatory Guide 1.8-Rev.3 May ANSI/ANS-3.1-1993 Implement as regulatory position. PSNE normally dispatch supervisors for 2000 Selection, Qualification, and pre-operational testing, start-up testing, and maintenance to nuclear power "Qualification and Training of Training of Personnel for Nuclear plants as contractor and as temporary position specifying in para 3.2 of Personnel for Nuclear Power Plants" Power Plants ANSI/ANS-3.1, following a contract with a customer (owner). 2 Regulatory Guide 1.28-Rev.3 August ANSI/ASME Comply with the provisions of Regulatory Guide 1.28, except as follows; 1985 NQA-1-1983 l.Regulatory Position, first sentence: Regarding to an applicable edition of "Quality Assurance Program NQA-la-1983 NQA-1, "1983 and la -1983 addenda" is revised to read "1994 edition." Requirements (Design and Construction)" 2.Table 1 Retention times for lifetime and nonpermanent records: Retention time of supplier's QA program manual is retained until purchase order close out, and calibration records is until re-calibrated, in lieu of 3 years. These alternations are specified in chapter 18 of the QA Program Description. 3 Regulatory Guide 1.33-Rev.2 ANSI N18.7-1976/ANS-3.2 Not applicable to standard scope of PSNE. PSNE normally dispatch February 1978 "Administrative Controls and supervisors for pre-operational testing, start-up testing, and maintenance to "Quality Assurance Program Quality Assurance for the unclear power plants as contractor and as temporary position specifying in Requirements (Operation) Operational Phase of Nuclear Power para 3.2 of ANSI/ANS-3.1, following a contract with a customer (owner). Plants" 4 Regulatory Guide 1.152-Revl January IEEE 7-4.3.2-1993 Implement as regulatory position 1996 "Standard Criteria for Digital "Criteria for Digital Computers in Computers in Safety Systems of Safety Systems of Nuclear Power Nuclear Power Generating Stations" Plants 5 Generic Letter 89-02 March 1989 EPRI NP-5652 June 1988 Implement as Generic Letter 89-02 Actions to Improve the Detection of "Guideline for the Utilization of Counterfeit and Fraudulently Commercial-Grade Items in Nuclear Marketed Products Safety-Related Applications (NCIG-07)" V CD

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in (2) ASME NQA-1 ýt1-N PSNE 7It ASME NQA-1 PSNE Lgffl:h7*t 1 MV*Ag 2S-2 2.1 M 3.1 *ii, The American Society of Nondestructive Testing Recommended Practice No. SNT-TC-1A, June 1980 Edition ý:VT 6-, t*-M-C27o ASME i1,I, ASME B&PV Code C 2 MZ-,* 12S-1 3.1 ODTR-Np~ ffl 0, IMV* )A

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M4 0cn U, (2) PSNE Positions on ASME NQA" 1 ASME NQA-1 PSNE Position Supplement 2S-2 Section 2.1 Comply with the provisions of this supplement, except as follows: Section 2.1 requires "The American Society of Nondestructive Testing Recommended Practice No. SNT-TC-1A, June 1980 Edition, and its applicable supplements shall apply as requirements to NDE personnel." Organization holding ASME Certificate of Authorization may qualify nondestructive examination personnel as required by the ASME B&PV Code. 2 Supplement 12S-1 Section 3.1 Comply with the provision of this supplement with the following clarification: Section 3.1, first sentence require "Measuring and test equipment shall be calibrated, adjusted, and maintained at prescribed intervals or, prior to use, against certified equipment having known valid relationships to nationally recognized standards." PSNE interpret "the certified equipment" includes certified equipments which; (1) have known valid relationship to Japanese nationally recognized standards, and (2) are calibrated by calibration laboratories accredited by an accrediting body belonging to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Agreement,, unless otherwise specified by contractual requirements. 3 Subpart 2.1 Implement as this subpart Quality Assurance Requirements for Cleaning of Fluid Systems and Associated Components for Nuclear Power Plants" 4 Subpart 2.2 Comply with the provisions of Subpart 2.2, except as follows: Quality Assurance Requirements for Packaging, Shipping, Receiving, Storage, and 3.4.2 Inert gas blankets: Provisions shall be made for measuring and maintaining the blanket pressure within Handling of Items for Nuclear Power Plants the required range within each pressurized item or container. Closures and seals shall be tightly secured so that the absolute (by mass) pressure after final seal is maintained for 24 hours without adding gas, prior to shipping the item from the manufacturer's plant. In lieu of the second sentence of 3.4.2 (c) above, specific procedure/manual may be provided and implemented for particular items such as the reactor pressure vessel (RPV). CD =3 a 0 X. 0 U) 0 0 m C:D (D

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Steel, Soils, and Foundations for Nuclear Power Plants 7

Subpart 2.7 Implement as this subpart Quality Assurance Requirements of Computer Software for Nuclear Facility Applications 8 Subpart 2.8 Implement as this subpart Quality Assurance Requirements for Installation, Inspection, and Testing of Mechanical Equipment and Systems For Nuclear Power Plants CD a =3 CL z C, 0 0 0 m i, C, 0 z C=) (D

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1. Section 1.1 Definitions:

PSNE interpret that accepted industry standard includes equivalent Japanese Nuclear Power Plants. industry standard such as JIS. 0

2. Section 2. General requirement: ANSI B30 series, Safety Standards for Cableway, Cranes, Derricks, 0 g Hoists, Hooks, Jacks, and Slings and ANSI/ASME A10.5 Safety Requirements for Material Hoists are C M specified to follow for equipment.

These requirements should be applied to the equipment in US. For equipment in Japan, "Industry Safety and Health Law", "Safety Ordinance for Cranes etc. (Ministry of --I Labor Ordinance NO.34)", and "Construction Code for Cranes (Ministry of Labor Notification No.134)" "0 shall be followed, in lieu of specified ANSI standards above. z 0

3. Section 6.1 Testing: This subpart requires 110% of the maximum load for a dynamic load test. For equipment in Japan, the test weight equal to 125% of the lift weight for nominal lift weight not exceeding U,

200t, and lift weight plus 50t for over 200t hoisting facilities shall be used, as specified Labor Standards U, Law of Japan, instead of the 110% lift weight.

4. Section 8.2 Engineer: This subpart requires the engineer shall be an engineering graduate of accredited college or university, or a Professional Engineer registered to practice in an appropriate discipline.

Individuals who do not possess these education and registration requirements should not be eliminated automatically when other factors provide sufficient demonstration of their abilities. These other factors are evaluated on a case-by-case basis and approved and documented by senior management. 10 Subpart 2.20 Implement as this subpart Quality Assurance Requirements for Subsurface Investigations for Nuclear Power Plants I- '0, '0}}