AREVA NP Inc. Quality Assurance Plan (QAP) For Design Certification of The U.S. EPR™ Topical Report

Download as pdf or txt
Download as pdf or txt
You are on page 1of 116

ANP-10266

Revision 3

AREVA NP Inc. Quality Assurance Plan (QAP) for

Design Certification of the U.S. EPR™

Topical Report

May, 2011

AREVA NP Inc.

Copyright © 2011
AREVA NP Inc.
All Rights Reserved
Abstract for ANP-10266
AREVA NP Inc. Quality Assurance Plan
For Design Certification of the U.S. EPR™

U.S. EPR™,Design Certification requires a Quality Assurance Plan (QAP) to be


prepared in accordance with 10 CFR 50, Appendix B, NQA-1-1994, and NUREG-0800;
this Topical Report has been prepared to meet the requirements of the aforementioned
standards/regulations. The U.S. EPR™,QAP implements the AREVA Inc. Quality
Assurance Program, 56-9141754; AREVA NP Inc. implementing procedures and
instructions implement the QAP. The Topical Report is divided into eighteen (18)
sections conforming to the requirements noted in 10 CFR 50, Appendix B.

This document describes the Quality Assurance Plan (QAP) for the design certification
of commercial nuclear operating plants, specifically the U.S. EPR™, and for products
and services supplied by AREVA NP Inc. under nuclear safety related criteria.
Addendum A of this Document describes the non-safety related QAP. Further, the QAP
contains the following appendices:

• Appendix A, QA Program Implementing Policies, Procedures, and Instructions


• Appendix B, Regulatory Commitments: Compliance with Applicable Regulatory
Guides, Generic Letters, and Standards
• Appendix C, Acronyms, Abbreviations, and Definitions

Appendix A contains a listing of AREVA NP Inc. Polices, Procedures, and Instructions


that implement the U.S. EPR™,QAP. Appendix B details how AREVA NP Inc. is
compliant with applicable Regulatory Guides, Generic Letters, and Standards.
Appendix C is a definitions reference for commonly used terms used in nuclear safety
related Quality Programs.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page i

Nature of Changes
Revision 03

Item No. Section(s) or Page(s) Description and Justification


1. Title Page Revised revision level and date;
2. Abstract Revised AREVA Inc. QA Program,
added EPR trademark throughout
3. Nature of Changes Re-ordered to have latest revisions
first. Added Revision 3 changes
4. Contents and Nomenclature Revised Page Numbering and section
titles as required. Added additional
Acronyms
5. Statement of Policy Updated to current Statement of
Policy
6. Section 0.1.3 Revised President and CEO to CEO
of AREVA NP Inc.
Revised VP, Sustainable
Development and Continuous
Improvement (SDCI) & Quality to VP,
Quality & Performance
6. Section 0.1.4 Revised VP, SDCI & Quality to
Quality & Performance
7. Section 1.0, Organization Completely Revised Organization and
updated exhibits
8. Section 2.1.3 Revised 56-5015885 to new AREVA
Inc. QA Program 56-9141754
9. Sections 2.1.4 and 2.1.5 Revised President and CEO to CEO
of AREVA NP Inc.
Revised VP, Sustainable
Development and Continuous
Improvement (SDCI) & Quality to VP,
Quality & Performance
In last paragraph of 2.1.5, Revised
President and CEO to CEO and COO
10. Section 7.4 Corrected grammatical error
11. Section 7.8 Revised VP, SDCI & Quality to VP,
Quality & Performance
12. Appendix A Updated QA Program Implementing
Documents as required
13. Addendum A Revised VP, SDCI & Quality to VP,
Quality & Performance
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page ii

Nature of Changes
Revision 02

Item No. Section(s) or Page(s) Description and Justification


1. Title Page Revised revision level and date;
added copyright notice; omitted “Non-
Proprietary”
2. Copyright Page/Disclaimer Page Omitted; copyright notice was added
to Title Page; Disclaimer Page no
longer necessary
3. Nature of Changes Added Revision 2 changes
4. Contents Revised Page Numbering as
Required.
5. Section 0.1.3 Revised VP, US Region Quality to
VP, Sustainable Development and
Continuous Improvement (SDCI) &
Quality
6. Section 0.1.4 Revised VP, US Region Quality to VP
SDCI & Quality
7. Section 1.0, Organization Updated the organization names and
descriptions as required, added
revised exhibits 1A and 1B
8. Section 2.1.3 Updated NUREG 0800, SRP 17.5
from draft
9. Sections 2.1.4 and 2.1.5 Revised VP, US Region Quality to VP
SDCI & Quality and Organization as
applicable
10. Section 5.3.1 Added alternative filing of procedures
into the Records Management
System
11. Section 7.8 Revised VP, US Region Quality to VP
SDCI & Quality
12. Appendix A Updated QA Program Implementing
Documents as required
13. Appendix B, 1a Updated Revision of Regulatory
Guide 1.26 to Revision 4 to agree
with FSAR commitment
14. Appendix B, 1d Updated Revision of Regulatory
Guide 1.29 to Revision 4 to agree
with FSAR commitment
15. Appendix B, 1f Updated Revision of Regulatory
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page iii

Item No. Section(s) or Page(s) Description and Justification


Guide 1.37 to Revision 1 per RAI 38,
Question 17.5-1
16. Appendix C-Definitions Corrected definition of Safety Related
17. Addendum A Revised VP, US Region Quality to VP
SDCI & Quality, corrected typo

Nature of Changes
Revision 01

Item No. Section(s) or Page(s) Description and Justification


1. Title Page Revised per RAI #1
Revised document number, revision
level and date
2. Disclaimer Page and Abstract Revised to provide applicability to
Design Certification only and other
updates
3. Statement of Policy Added Statement of Policy Page (RAI
#5)
4. Nomenclature Added acronym and definition of
Purchase Requisition
5. Section 0.0, Introduction Revised per RAIs #1 and #2
6. Section 0.1.4 Revised to update document
issuance and revision requirements
7. Section 0.1.5 Deleted Document Assignments as
not applicable to the Topical Report
8. Section 1.0, Organization Revised per RAIs #1, #3, #4, #6, #7
and #8
Also, updated the organization names
and descriptions as required, added
exhibits 1A and 1B
9. Section 2.0, Quality Assurance Revised per RAIs # 1, #3, # 4, #9,
Program #10, #11, #12 and #56
Also, updated Section 2.1.3, QAP
Requirements
10. Section 3.0, Design Control Revised per RAIs # 1,#3,# 4 #13,#14,
#16 and, #17
11. Section 4.0, Procurement Document Revised per RAIs # 1,#3,# 4
Control Updated Section 4.2.1 to include
Purchase Requisition (PR) options
and clarify PO use.
12. Section 5.0, Instruction, Procedures Revised per RAIs # 1,#3, #4 and #15
and Drawings
13. Section 6.0, Document Control Revised per RAIs # 1,#3, #4 and #18
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page iv

Item No. Section(s) or Page(s) Description and Justification


14. Section 7.0, Control of Purchased Revised per RAIs #1, #3, #4, #21,
Materials, items and Services #22, #23 and #25
15. Section 8.0, Identification and Revised per RAIs #1,#3, and #4
Control of Items and Materials
16. Section 9.0, Control of Special Revised per RAIs #1, #3, #4
Processes
17. Section 10.0, Inspection Revised per RAIs #1, #3, # 4
18. Section 11.0, Test Control Revised per RAIs #1, #3, # 4, and
#29
19. Section 12.0, Control of Measuring Revised per RAIs #1, #3, #4, #30 and
and Test Equipment #31
20. Section 13.0, Handling, Storage, and Revised per RAIs #1, #3, #4
Shipping
21. Section 14.0, Inspection, Test, and Revised per RAIs #1, #3, #4
Operating Status
22. Section 15.0, Control of Revised per RAIs #1, #3, #4, and #38
Nonconforming Items
23. Section 16.0, Corrective Action Revised per RAIs #1, #3, #4, #42
and #43
24. Section 17.0, Quality Assurance Revised per RAIs #1, #3, #4, #44,
Records #45, #46, #47 and #49
25. Section 18.0, Audits Revised per RAIs #1, #3, #4, #48,
#50, #51, #52 and #53
26. Appendix A Updated document numbers and
titles. Added reference to Procedure
1724-01.
27. Appendix B Regulatory Revised per RAIs #55 and #56
Commitments: Compliance with Also deleted reference to Reg. Guide
Applicable Regulatory Guides, 1.8.
Generic Letters and Standards
28. Appendix C Definitions Revised per RAIs #40, #41, #57 and
#58
Added definition of Purchase
Requisition
29. Addendum A Non-Safety Related Revised per RAI #59
Products and Services Updated Section A-4.2 Procurement
Process to include reference to PR
30. All Sections Corrected miscellaneous
typographical errors
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page v

NOTE: The above stated changes are in accordance with 10 CFR


50.54(a)(3). The changes do not reduce the commitments to the quality
assurance program description as approved in ANP-10266A, Revision 1.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page vi

Statement of Policy
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page vii

Contents
Page
Nature of Changes ....................................................................................................... iii
Statement of Policy ...................................................................................................... vi
Contents....................................................................................................................... vii
Nomenclature .............................................................................................................. xii
0.0 INTRODUCTION ............................................................................................... 0-1
0.1 Purpose .................................................................................................. 0-1
0.1.1 Scope........................................................................................... 0-1
0.1.2 General ........................................................................................ 0-2
0.1.3 Responsibility ............................................................................... 0-2
0.1.4 Document Issuance and Revision................................................ 0-2
1.0 ORGANIZATION............................................................................................... 1-1
1.1 Purpose .................................................................................................. 1-1
1.2 AREVA NP Inc. (Exhibit 1)...................................................................... 1-2
1.3 Reactors and Services (Exhibit 2)........................................................... 1-2
1.4 Engineering and Projects (Exhibit 3)....................................................... 1-2
1.5 Quality and Performance (Exhibit 4) ....................................................... 1-3
1.6 Human Resources (Exhibit 1) ................................................................. 1-4
1.7 Chief Financial Officer (Exhibit 1) ........................................................... 1-4
1.8 Marketing (Exhibit 1) ............................................................................... 1-4
1.9 Legal (Exhibit 1)...................................................................................... 1-5
1.10 Purchasing (Exhibit 1)............................................................................. 1-5
1.11 Information Systems (Exhibit 1) .............................................................. 1-5
2.0 QUALITY ASSURANCE PROGRAM ............................................................... 2-1
2.1 Purpose .................................................................................................. 2-1
2.1.1 Scope........................................................................................... 2-1
2.1.2 General ........................................................................................ 2-1
2.1.3 QAP Requirements ...................................................................... 2-2
2.1.4 QAP Implementation .................................................................... 2-2
2.1.5 QAP Assessment ......................................................................... 2-3
2.1.6 QAP Indoctrination and Training .................................................. 2-4
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page viii

3.0 DESIGN CONTROL .......................................................................................... 3-1


3.1 Purpose .................................................................................................. 3-1
3.2 General ................................................................................................... 3-1
3.3 Implementation ....................................................................................... 3-1
3.4 Design Inputs.......................................................................................... 3-2
3.5 Design Interfaces.................................................................................... 3-3
3.6 Design Verification .................................................................................. 3-3
3.6.1 Independent Review of Design Documents ................................. 3-3
3.6.2 Design Analyses .......................................................................... 3-4
3.6.3 Design Review Boards (DRB) ...................................................... 3-4
3.6.4 Design Verification Testing .......................................................... 3-4
3.7 Design Changes ..................................................................................... 3-5
3.8 Engineering Assistance/Advice and Consultation................................... 3-5
4.0 PROCUREMENT DOCUMENT CONTROL ...................................................... 4-1
4.1 General ................................................................................................... 4-2
4.2 Implementation ....................................................................................... 4-2
4.2.1 Procurement Process................................................................... 4-2
4.2.2 Procurement Document Content.................................................. 4-2
4.2.3 Procurement Document Review................................................... 4-3
4.2.4 Changes to Procurement Documents .......................................... 4-3
5.0 INSTRUCTIONS, PROCEDURES AND DRAWINGS....................................... 5-1
5.1 Purpose .................................................................................................. 5-1
5.2 General ................................................................................................... 5-1
5.3 Implementation ....................................................................................... 5-2
5.3.1 Administrative Policies, Procedures, and Instructions.................. 5-2
5.3.2 Drawings and Specifications ........................................................ 5-2
6.0 DOCUMENT CONTROL ................................................................................... 6-1
6.1 Purpose .................................................................................................. 6-1
6.2 General ................................................................................................... 6-1
6.3 Implementation ....................................................................................... 6-2
6.3.1 Document Control System ........................................................... 6-2
6.3.2 Document Change Control........................................................... 6-2
6.3.3 Release of Documents................................................................. 6-2
6.3.4 Supplier Prepared Documents ..................................................... 6-2
6.3.5 Customer Prepared Documents................................................... 6-3
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page ix

7.0 CONTROL OF PURCHASED MATERIALS, ITEMS, AND SERVICES............ 7-1


7.1 Purpose .................................................................................................. 7-2
7.2 General ................................................................................................... 7-2
7.3 Supplier Evaluation and Selection .......................................................... 7-2
7.3.1 Dedication of Commercial Grade Items and/or
Services ....................................................................................... 7-3
7.4 Approved Supplier List (ASL).................................................................. 7-4
7.5 Procurement Process Monitoring............................................................ 7-4
7.6 Item/Service Verification ......................................................................... 7-5
7.6.1 Receiving Inspection .................................................................... 7-5
7.7 Supplier Nonconformances..................................................................... 7-5
7.8 Certifications of Conformance (CoC/QA Data Packages)....................... 7-5
8.0 IDENTIFICATION AND CONTROL OF ITEMS AND MATERIALS .................. 8-1
8.1 Purpose .................................................................................................. 8-1
8.2 General ................................................................................................... 8-1
8.3 Implementation ....................................................................................... 8-2
9.0 CONTROL OF SPECIAL PROCESSES ........................................................... 9-1
9.1 Purpose .................................................................................................. 9-1
9.2 General ................................................................................................... 9-1
9.3 Implementation ....................................................................................... 9-1
9.3.1 Welding ........................................................................................ 9-2
9.3.2 Heat Treatment ............................................................................ 9-2
9.3.3 Nondestructive Examination (NDE).............................................. 9-3
10.0 INSPECTION................................................................................................... 10-1
10.1 Purpose ................................................................................................ 10-1
10.2 Scope.................................................................................................... 10-1
10.3 General ................................................................................................. 10-1
10.4 Implementation ..................................................................................... 10-2
10.4.1 Inspection Types ........................................................................ 10-2
10.4.2 Inspection Plan........................................................................... 10-2
10.4.3 Inspection Result........................................................................ 10-2
10.4.4 Review of Completed Inspection Documentation....................... 10-3
11.0 TEST CONTROL............................................................................................. 11-1
11.1 Purpose ................................................................................................ 11-1
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page x

11.2 General ................................................................................................. 11-2


11.3 Implementation ..................................................................................... 11-2
12.0 CONTROL OF MEASURING AND TEST EQUIPMENT................................. 12-1
12.1 Purpose ................................................................................................ 12-1
12.2 General ................................................................................................. 12-1
12.3 Implementation ..................................................................................... 12-2
12.3.1 Procedures................................................................................. 12-2
12.3.2 Control of M&TE......................................................................... 12-2
12.3.3 M&TE Suppliers and M&TE Calibration Services....................... 12-3
12.3.4 Customer Furnished M&TE........................................................ 12-4
13.0 HANDLING, STORAGE, AND SHIPPING ...................................................... 13-1
13.1 Purpose ................................................................................................ 13-1
13.2 General ................................................................................................. 13-1
13.3 Implementation ..................................................................................... 13-2
13.3.1 Cleanliness ................................................................................ 13-2
13.3.2 Storage ...................................................................................... 13-2
13.3.3 Packaging .................................................................................. 13-2
13.3.4 Handling ..................................................................................... 13-2
13.3.5 Shipping ..................................................................................... 13-2
14.0 INSPECTION, TEST, AND OPERATING STATUS ........................................ 14-1
14.1 Purpose ................................................................................................ 14-1
14.2 General ................................................................................................. 14-1
14.3 Implementation ..................................................................................... 14-2
14.3.1 Status Indication by Travelers or Manufacturing/Field
Procedures................................................................................. 14-2
14.3.2 Status Indication by Tags........................................................... 14-2
15.0 CONTROL OF NONCONFORMING ITEMS ................................................... 15-1
15.1 Purpose ................................................................................................ 15-1
15.2 General ................................................................................................. 15-1
15.3 Internal Nonconformances.................................................................... 15-2
15.3.1 Nonconformances ...................................................................... 15-2
15.3.2 Safety Concerns......................................................................... 15-3
15.3.3 Audit Findings (AF) .................................................................... 15-3
15.4 Supplier Nonconformances................................................................... 15-3
15.5 Contract Variation Approval Request (CVAR) ...................................... 15-3
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page xi

16.0 CORRECTIVE ACTION .................................................................................. 16-1


16.1 Purpose ................................................................................................ 16-1
16.2 General ................................................................................................. 16-1
16.3 Implementation ..................................................................................... 16-2
17.0 QUALITY ASSURANCE RECORDS .............................................................. 17-1
17.1 Purpose ................................................................................................ 17-1
17.2 General ................................................................................................. 17-1
17.3 Implementation ..................................................................................... 17-3
18.0 AUDITS ........................................................................................................... 18-1
18.1 Purpose ................................................................................................ 18-1
18.2 General ................................................................................................. 18-1
18.3 Internal Audits....................................................................................... 18-2
18.4 Supplier Audits...................................................................................... 18-2
18.5 Audit Reports ........................................................................................ 18-4
APPENDIX A QA Program Implementing Policies, Procedures, and
Instructions ......................................................................................... A-1
APPENDIX B Regulatory Commitments: Compliance with Applicable
Regulatory Guides, Generic Letters, and Standards....................... B-1
APPENDIX C Definitions........................................................................................... C-1
ADDENDUM A Non-Safety Related Products and Services ................................ AP-1
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page xii

Nomenclature

Acronym Definition

ADI Applicable Document Index

ADL Applicable Documents List

AF Audit Finding

ANSI American National Standards Institute

ASL Approved Suppliers List

ASME American Society of Mechanical Engineers

CR Condition Report

CFR Code of Federal Regulations

CO Change Order

CoC Certificate of Conformance

CVAR Contract Variation Approval Request

DCF Document Comment Form

DRB Design Review Board

DRN Document Release Notice

FCA Field Change Authorization

HDL Historical Document List


ITAAC Inspections, Tests, Analyses, and Acceptance
Criteria
I&C Instrumentation & Control

I&MC Inspection and Material Control


AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page xiii

Acronym Definition

M&TE Measuring & Test Equipment

NDE Non-Destructive Examination

NIAC Nuclear Industry Assessment Committee

NIST National Institute of Standards and Technology

NRC Nuclear Regulatory Commission

OEM Original Equipment Manufacturer

OI Operating Instruction

OOC Out of Commission

PA Purchasing Authorization

PO Purchase Order

POPS Policies and Procedures System

PR Purchase Requisition

PWA Project Work Authorization

QA Quality Assurance

QAP Quality Assurance Plan

QC Quality Control

RDR Receipt Discrepancy Report

RFQ Request for Quote

WI Working Instruction
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 0-1

0.0 INTRODUCTION

0.1 Purpose

This document describes the Quality Assurance Plan applicable to the Design
Certification of the U.S. EPR. The plan is based on the Eighteen (18) point criteria of 10
CFR 50, Appendix B, and ANSI/ASME NQA-1-1994.

However, the scope of the design certification project does not include fabrication,
erection, installation or operations.

Therefore, this QAP provides the specific applicability and application of the Criteria of
Appendix B and the Basic, Supplemental and applicable Subpart requirements of
ANSI/ASME NQA-1-1994 to the U.S. EPR Design Certification Project.

Each section of this QAP clearly delineates the applicability of the criteria to the U.S.
EPR Design Certification Project.

ASME Boiler and Pressure Vessel Code items are covered under a separate Quality
Assurance Program. Addendum A of this Document describes the non-safety related
QAP.

0.1.1 Scope

The applicable scope and criteria as specified in Sections 1 – 18 of this document is


mandatory for nuclear safety related activities associated with the U.S. EPR Design
Certification Project. Addendum A of this Document describes the requirements for
non-safety related activities. Refer to Appendix C for definitions of safety related and
non-safety related.

This QAP is in compliance with the regulations, codes, standards, and other
requirements listed in Section 2.1.3. Each section of this document provides the
controls in place to accomplish compliance to the applicable criteria specified in each
section. Typical policies, procedures, and instructions which detail how these controls
are implemented are listed in Appendix A.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 0-2
0.1.2 General

AREVA NP Inc. has primary locations in Lynchburg, Virginia, Charlotte, North Carolina,
and Marlborough, Massachusetts with other satellite offices positioned in the U.S.

0.1.3 Responsibility

The CEO of AREVA NP Inc. has the overall responsibility for the quality of work. The
Vice President, Quality & Performance, is responsible for developing this QAP and for
assuring its proper implementation. All personnel are responsible for implementing this
QAP when performing work.

0.1.4 Document Issuance and Revision

The Vice President, Quality & Performance is responsible for the preparation,
maintenance, and revision of this Document. This document is authorized for use and
shall be fully implemented upon release.

This document will be reviewed once each calendar year by AREVA NP Inc. QA and
revised as necessary to assure that it continues to accurately describe the QAP and any
changes due to regulations, commitments, reorganizations, or program improvements
from continuous review of assessment results and process improvement initiatives. All
revisions will be prepared by QA with input from cognizant, affected department
managers.

Any changes that reduce commitments in the approved QAP will be submitted to the
NRC for review and approval prior to implementation as required by 10 CFR 50.54(a)(3)
and 10 CFR 50.55(f)(3). Changes that do not reduce commitments will be submitted in
accordance with 10 CFR 50.54 and 10 CFR 50.55(f)(3), as applicable.

For the purposes of 10 CFR 50.54(a)(3) and 10 CFR 50.55(f)(3) the following are not
considered a reduction in commitment.

• Quality assurance program changes involving administrative improvements and


clarifications, spelling corrections, punctuation, or editorial items
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 0-3
• The use of a QA standard approved by the NRC which is more recent than the
QA standard in the licensee’s current QA program at the time of the change
• The use of a quality assurance alternative or exception approved by an NRC
safety evaluation, provided that the bases of the NRC approval are applicable to
the licensee’s facility
• The use of generic organizational position titles that clearly denote the position
function, supplemented as necessary by descriptive text, rather than specific
titles
• The use of generic organizational charts to indicate functional relationships,
authorities, and responsibilities, or, alternately, the use of descriptive text
• The elimination of quality assurance program information that duplicates
language in quality assurance regulatory guides and quality assurance standards
to which the licensee is committed
• Organizational revisions that ensure that persons and organizations performing
quality assurance functions continue to have the requisite authority and
organizational freedom, including sufficient independence from cost and
schedule when opposed to safety considerations

Revisions to this document are made by revision of the entire document.

All pages of the revised document shall indicate the new revision level. Changes made
in the revision process are indicated on the nature of changes page.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 1-1

1.0 ORGANIZATION

Section 1.0, Organization, applies to the Design Certification Project.

This section complies with Criterion I of 10 CFR 50, Appendix B, Organization, and
Basic Requirement 1, Organization and Supplementary Requirements for Organization,
1S-1, of ANSI/ASME NQA-1-1994.

1.1 Purpose

AREVA NP Inc., the Company, is the U.S. Regional Division, wholly owned subsidiary
of AREVA SA that is headquartered in Paris, France. Further, the Company is
organized into five (5) major Business Groups, Business Units, and a resource group as
shown in Exhibit 1. However, for the purposes of this QAP, it is applicable only to the
following organizations:

ƒ Reactors and Services U.S., with the exception of Nuclear Measurements


and Equipment
ƒ Engineering and Projects resource group U.S.
ƒ U.S. Support Functions such as Quality and Performance, Human
Resources, Information Systems, Finance, Legal, Marketing, and
Purchasing.

The Company’s QAP covers all nuclear safety related activities associated with the
design and deployment of commercial nuclear power plants, specifically US EPR™ ,
and products and services supplied by these groups for the US EPR™.

It is the responsibility of management to ensure that personnel affecting quality related


activities are qualified in accordance with written procedures.

AREVA NP Inc. management is responsible to ensure that the size of the Quality
Assurance organization is commensurate with the duties and responsibilities assigned.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 1-2

The functions and responsibilities of the organizations of the Company which operate
under and implement the QAP are described as follows:

1.2 AREVA NP Inc. (Exhibit 1)

The CEO of AREVA NP Inc. is responsible for the management of the Company’s
nuclear energy products and services, energy management, and energy market
systems in the U.S. The portfolio includes solutions for renewable energy and expertise
in all aspects of the nuclear fuel cycle, including reactor design and construction. The
Business Groups and Units participating in this QAP are depicted in Exhibit 1.

1.3 Reactors and Services (Exhibit 2)

The Reactors and Services U.S. Business Group Senior Executive Vice President
reports to the CEO of AREVA NP Inc. and to the Reactors and Services Executive in
France. The organization specializes in the design, construction, and servicing of
pressurized water reactors (PWRs), boiling water reactors (BWRs), and research
reactors, as well as in the manufacture of radiation detection and analysis
instrumentation

1.4 Engineering and Projects (Exhibit 3)

The Engineering and Projects Senior Executive Vice President reports to the CEO of
AREVA NP Inc and to the Engineering and Projects Executive in France. The
Engineering & Projects organization provides design, construction and commissioning,
inspection and project management services exclusively for the AREVA
nuclear Business Groups.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 1-3
1.5 Quality and Performance (Exhibit 4)

The Vice President of Quality and Performance reports to the CEO of AREVA NP Inc.
Company policy dictates that the Vice President of Quality and Performance is
responsible for preparation, implementation, and maintenance of this QAP.
Organizational freedom and independence from the activities being regulated is
ensured by providing the Vice President of Quality and Performance with access to the
Senior Executives, Vice Presidents, managers of the regulated activities, and to the
CEO of AREVA NP Inc.

The reporting structure provides sufficient authority for Quality and Performance
personnel to:

Identify quality problems,

Initiate, recommend, or provide solutions through designated channels,

Verify implementation of solutions,

Suspend or control further processing or delivery of nonconforming items until proper


disposition of the identified deficiency has been approved and documented.
Responsibility for the control of further processing, delivery, installation, or operation of
nonconforming items shall be designated in writing.

The Manager of Quality Programs reports to the Vice President of Quality and
Performance; the function is responsible for the implementation and maintenance of this
QAP and the ASME Section III and XI Quality Assurance Program. The group is also
responsible for the implementation and maintenance of the Corrective Action Program.
The Manager of Quality Programs is also responsible for managing the Internal,
Supplier, and Customer Audits Programs for the activities covered by this QAP.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 1-4
The Manager of Quality Operations also reports to the Vice President Quality and
Performance and is responsible for ensuring compliance with codes and standards in
the preparation and execution of projects, project support, qualification of inspection and
surveillance personnel, and supplier oversight planning.

The Manager of Records Management also reports to the Manager Quality and
Performance. The Records Management function is responsible for duplication,
storage, and retention of quality related records.

1.6 Human Resources (Exhibit 1)

The Vice President of Human Resources U.S. reports to the CEO of AREVA NP Inc.
and to the Human Resources Executive in France. This group supports the AREVA
Business Groups in the U.S. by assisting with all personnel actions, such as
recruitment, hiring, promotion, training, compensation, benefits, and termination.

1.7 Chief Financial Officer (Exhibit 1)

The AREVA Inc. Vice President, Chief Financial Officer (CFO), and Treasurer reports to
the CEO of AREVA NP Inc and to the Finance Executive in France. The mission of this
organization is to coordinate financial management operations and suggest
recommendations for the improvement of the group's financial performance.

1.8 Marketing (Exhibit 1)

The Vice President of Marketing reports to the CEO of AREVA NP Inc. and to the
Marketing Executive in France. The organization has the overall responsibility for
business marketing for the Company.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 1-5
1.9 Legal (Exhibit 1)

The Chief Legal Director reports to the CEO of AREVA NP Inc and to the Legal
Executive in France. This function provides legal assistance and support to the AREVA
Business Groups in the U.S.

1.10 Purchasing (Exhibit 1)

The Vice President of Purchasing reports to the CEO of AREVA NP Inc. and to the
Purchasing Executive in France. The purchasing function is responsible for providing
the company with a competitive advantage through proactive supplier development and
management of an effective, flexible and reliable supply chain. This function is
responsible for all safety related procurements made in the U.S.

1.11 Information Systems (Exhibit 1)

The Vice President of Information Systems reports to the CEO of AREVA NP Inc. and to
the Information Systems Executive in France. The function supports AREVA NP Inc.
and the Business Groups with data management and communication.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 1-6

EXHIBIT 1

AREVA U.S. Organization


AREVA U.S. Support Organizations
Gvt. Affairs
Finance
HR
Legal
CEO Marketing
AREVA NP Inc. Strategy
Purchasing
Communication
Information Systems
Quality and PI
SDCI

Mining Front Reactors & Back End Renewables


U.S. End U.S. Services U.S. U.S. U.S.
Fuel Installed Base* Transnuclear ADAGE
New Builds
AREVA Equipment* Recycling Wind
Enrichment Products and Tech.*
Services Nuclear Measure- MOX Solar
ment

FE Sales AREVA Federal Services

Engineering and Projects


*IBB Sales includes
sales for these BUs
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 1-7

EXHIBIT 2

R&S BG
HR Quality Finance
R&S BG
Legal I.S. Communications

R&S BG SUPPORT FUNCTIONS


Executive Assistants
HR

Communications
Performance Improvement
Legal

New Builds New Builds Support


North America Functions

Installed Base Installed Base


Support
North America
Functions

Equipment Equipment
North America Support
Functions

Product & Technology Product & Technology


North America Support
Functions

Nuclear Measurements Nuclear Measurements


North America Support
Functions
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 1-8

EXHIBIT 3

Engineering & Projects Organization


E&P
North America

Executive Assistant Quality


Quality

Finance
SDCI Finance
SDCI

Human Resources
Human Resources
Processes, Methods & Tools

Process, Methods & Tools


Project Operations
Project Operations
Design

Design Engineering Construction & Commissioning


Construction &
Commissioning

Project Management Planning & Footprint Strategy


Planning &
Project Management Footprint Strategy

Internal Communication
Programs & Internal
Communications
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 1-9

EXHIBIT 4

Quality & Performance Organization

Quality
Quality &
& Performance
Performance Global Organizations
Q&P

Executive
Executive Assistant
Assistant

Support Functions
AREVA Group

Regulatory Performance
Performance Performance
Regulatory Affairs
Affairs Improvement
Improvement
Performance
Improvement
Improvement

Records
Records Mgmt
Mgmt Quality
Quality Programs
Programs Quality
Quality Programs
Programs

Quality
Quality Operations
Operations EH&S
EH&S D3SE
D3SE

Access
Access Control
Control Training
Training Programs
Programs Training
Training
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 2-1

2.0 QUALITY ASSURANCE PROGRAM

The Quality Assurance Program, as specified in each section of the QAP, applies to the
Design Certification Project.

This section complies with Criterion II of 10 CFR 50, Appendix B, Quality Assurance
Program, and Basic Requirement 2, Quality Assurance Program, and the following
supplemental requirements of ANSI/ASME NQA-1-1994:

• 2S-1, Supplementary Requirements for the Qualification of Test and Inspection


Personnel
• 2S-2, Supplementary Requirements for the Qualification of Nondestructive
Examination Personnel
• 2S-3, Supplementary Requirements for the Qualification of Quality Assurance
Program Audit Personnel
• 2S-4, Supplementary Requirements for Personnel Indoctrination and Training

2.1 Purpose

This section defines the QAP implemented by AREVA NP Inc. for nuclear safety related
activities, specifically the U.S. EPR.

2.1.1 Scope

The QAP establishes the prerequisites for achieving quality, such as the need for
specialized equipment and skills, use of suitable administrative, process, and
environmental controls, training and indoctrination of personnel performing activities
affecting quality, and the need for verification of quality by reviews, inspection,
examination, and test. The QAP assures that activities affecting quality are
accomplished under suitably controlled conditions. It also provides for the development,
control, and use of computer programs.

2.1.2 General

AREVA NP Inc. has established and implemented procedures which provide


requirements and guidelines for establishing the safety classification of systems,
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 2-2

structures, and components (SSC), and for determining the quality group classification,
applicable quality standards, and the seismic design classification, applicable quality
standards, and the seismic design classification of SSCs commensurate with their
respective safety classification.

Structures, systems and components important to safety are designed, fabricated,


erected and tested to quality standards commensurate with the importance of the safety
functions to be performed. Where generally recognized codes and standards are used,
they are justified and evaluated to determine their applicability, and supplemented or
modified as necessary to assure a quality product in keeping with required safety
functions.

2.1.3 QAP Requirements

This QAP is organized and administered to comply with:

• 10 CFR 50, Appendix A, General Design Criteria 1(a), Appendix B, 50:55(a), and
50:55(b)
• 10 CFR 21
• 10 CFR 50.34(f)(3)(iii)(A), (C), (H)
• Quality Assurance related to NRC Regulatory Guides, Generic Letter
commitments and other standards as described in Appendix B of this Document
• ANSI/ASME NQA-1-1994, Basic and Supplemental Requirements and applicable
subparts
• NUREG 0800, SRP 17.5, Quality Assurance Program Description-Design
Certification, Early Site Permit and New Licensee Applicants as applicable to
Design Certification
• 56-9141754, AREVA Inc. Quality Assurance Program
• Other quality requirements as may be imposed by contract

2.1.4 QAP Implementation

This QAP establishes and maintains standards of quality through the development and
use of quality engineering and manufacturing practices, which are documented by
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 2-3

written policies, procedures, and instructions. These policies, procedures, and


instructions are controlled as described in Section 5 and 6 of this QAP; they have been
coordinated with and are mandatory for each of the applicable groups within AREVA NP
Inc.

Typical policies, quality assurance plans, procedures, and instructions that implement
this QAP are referenced in Appendix A. AREVA NP Inc. may add, modify, and/or delete
the referenced policies, procedures, and instructions without changing the intent of the
QAP. Therefore, the document references should only be considered as
representative; these references will be updated as necessary during subsequent
revisions of this document. If required by contract, customer originated procedures may
be used to implement this QAP provided their use is defined in contract unique Project
Management Documents or QA Plans which have been approved by the CEO of
AREVA NP Inc. (or designee), the AREVA NP Inc. Vice President, Quality &
Performance, and the responsible project management function.

A QAP may be prepared as needed to address the application of a contract which


implies a departure from the general requirements of this QAP; a QAP may also be
prepared to address the application of a contract which implies additional processes
without departure from the general requirements of this QAP.

QA personnel are charged with escalating to the Vice President, Quality & Performance,
for resolution, any quality related problems that cannot be resolved at their level. In
turn, the Vice President, Quality & Performance will escalate to the CEO of AREVA NP
Inc. any quality related problem that cannot be resolved.

2.1.5 QAP Assessment

Assessments of the scope, status, adequacy, and compliance of this QAP with
Appendix B of 10 CFR 50, NQA-1, and other QAP commitments, such as 10 CFR 21,
are performed by AREVA NP Inc. staff management in several ways. The Vice
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 2-4

President, Quality & Performance evaluates this document once every calendar year
and updates to incorporate any administrative or operational changes necessary to
ensure that it accurately describes the QAP. When changes are desired, the affected
staff managers shall provide the Vice President, Quality & Performance input as to the
status, adequacy, and effectiveness of that part of the QAP for which they have been
designated responsibility. In addition, at the direction of the Vice President, Quality &
Performance, qualified auditors perform an independent audit of the Quality &
Performance organizations implementation of the QAP once each calendar year. The
results of these audits are provided to the CEO of AREVA NP Inc., the Vice President,
Quality & Performance, and the Quality Managers.

The CEO of AREVA NP Inc. periodically conducts staff meetings where each staff
manager presents the status of activities within his group and any problems that require
resolutions by AREVA NP Inc. management. In addition, written monthly reports are
made by each staff manager describing their significant activities and problems during
the month. The CEO of AREVA NP Inc. receives copies of the results of internal audits
performed by the Quality & Performance Organization.

The CEO and COO of AREVA NP Inc., through customer feedback, personal
observations, staff meetings, monthly reports, and audit reports, assures himself of the
adequacy and effectiveness of this QAP and implementing procedures.

2.1.6 QAP Indoctrination and Training

2.1.6.1 AREVA NP Inc. Personnel

Indoctrination and training requirements of this QAP are provided to all personnel
engaged in activities covered by this QAP. This indoctrination and training is conducted
in accordance with written procedures and includes instruction as to the purpose,
scope, and implementation of the quality related documents, policies, procedures, and
instructions.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 2-5

2.1.6.2 AREVA NP Inc. QA/QC Personnel

In addition to the indoctrination and training described above, personnel performing


inspection, surveillance, and audit activities are qualified. This qualification is
conducted and documented in accordance with the applicable requirements listed in
Section 2.1.3 of this QAP.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 3-1

3.0 DESIGN CONTROL

Section 3.0, Design Control, applies to the Design Certification Project.

This section complies with Criterion III of 10 CFR 50, Appendix B, Design Control, and
Basic Requirement 3, Design Control, and the following supplemental requirements and
Subparts of ANSI/ASME NQA-1-1994:

• 3S-1, Supplementary Requirements for Design Control


• 11S-2, Supplementary Requirements for Computer Program Testing

Computer Software utilized for safety-related design analysis also complies with
Subpart 2.7, Quality Assurance Requirements of Computer Software for Nuclear Facility
Applications.

3.1 Purpose

This section describes the method used to provide control of design, design verification,
and analysis activities.

3.2 General

AREVA NP Inc. maintains design control during the performance of work activities
associated with this QAP. The project management function establishes in writing to
the responsible design organizations the scope, objectives, requirements, and safety
classification. When design review boards are required, the requirement is identified by
the responsible technical manager with concurrence of the responsible project
management function.

3.3 Implementation

Design control measures are applied to safety related items and services as defined in
written procedures and instructions.

These design control measures are implemented through procedures which include the
provisions for the control of design inputs, processes, outputs, verification, independent
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 3-2

review, analysis, verification testing, design changes, organizational interfaces within


AREVA NP Inc. and with suppliers, records and QA reviews.

AREVA NP Inc. has established and implements a process to control the design and
design changes of items that are subject to the provisions of this QAP. These
provisions assure that design inputs (such as design bases and the performance,
regulatory, quality, and quality verification requirements) are correctly translated into
design outputs (such as analyses, specifications, drawings, procedures, and
instructions) so that the final design output can be related to the design input in
sufficient detail to permit verification.

The design control program includes interface controls necessary to control the
development, verification, approval, release, status, distribution and revision of design
inputs and outputs. Design changes are reviewed and approved by the AREVA NP Inc.
design organization.

3.4 Design Inputs

Procedures have been established for the preparation and review of design documents.
Design inputs, e.g., the design bases, performance and regulatory requirements and
codes and standards, are correctly translated into design outputs, e.g., specifications,
drawings, procedures, and instructions.

The appropriate engineering organization is responsible for the preparation, review,


approval, and verification of design documents for items and services within the
respective area of responsibility. Design documents include such documents as plant
technical requirements, system design requirements, system descriptions, design
drawings, design analyses, computer program documentation, specifications and
procedures. These documents specify technical and quality requirements appropriate
to the activities they cover, and are independently reviewed for completeness and
technical accuracy. AREVA NP Inc. design records are maintained to provide evidence
that the design supports the facility design, construction and operations and that the
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 3-3

design was properly accomplished. Records include not only the final design output
and revisions to the final output, but also the important design steps (e.g., calculations,
analyses, and computer programs) and the sources of input that support the final
output.

Revisions to design documents are subject to the same review and approval process as
the original documents.

QA provides an overview during audits of design documents, such as drawings and


specifications used as procurement documents or as manufacturing requirements for
the inclusion of appropriate QA requirements. Deviations from specified quality
standards are identified and controlled in accordance with written procedures.

3.5 Design Interfaces

Procedures establish methods for the identification and control of design interfaces, for
coordination among participating design organizations, and for review, approval,
release, distribution, and revision of documents.

The project management function and responsible technical management establishes


design interfaces.

3.6 Design Verification

Procedures are established to assure adequacy and accuracy of designs. Verification


methods include independent review of design documents, design analyses
(calculations), design review boards, and design verification testing. The design
organization determines design verification methods to be used.

3.6.1 Independent Review of Design Documents

All design documents are independently reviewed for completeness and technical
accuracy by a technically qualified individual other than the preparer of the document.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 3-4

Design documents are reviewed by individuals knowledgeable and trained in QA and


qualified to ensure the documents contain the necessary QA requirements.

In certain instances, the reviewer may be the preparer’s supervisor or manager as


explained in AREVA NP Inc.’s position on Regulatory Guides 1.28 and 1.64 contained
in Appendix B.

3.6.2 Design Analyses

Design analyses (calculations) are used to establish design requirements or to verify the
design. The analyst is required to document the calculations as to purpose,
assumptions, method, design input data, results, and conclusions in such a manner that
an independent reviewer can verify its technical accuracy. Design analyses are
checked by independent reviewers who are competent in the particular type of analysis.
Computer programs used for design analyses are certified or verified and validated as
appropriate.

3.6.3 Design Review Boards (DRB)

Design Review Boards (DRB) are conducted in accordance with written procedures for
new designs and major changes to existing designs as determined by the responsible
technical manager and project management functions.

A DRB verifies the adequacy of a design by assuring that it is based on sound technical
principles and that it meets specified requirements. DRB’s may be conducted at the
conceptual, preliminary, and/or final design stages.

Results of DRB’s are documented and the responsible technical manager must resolve
DRB comments, as necessary, to close out the DRB.

3.6.4 Design Verification Testing

Design verification by testing is used whenever engineering judgment leads to the


conclusion that design analyses or previous experience cannot substantiate a design or
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 3-5

design feature. Verification testing is incorporated using written test procedures which
incorporate the requirements of the design documents that establish the design limits of
the items or features being tested.

If verification of a design or design feature is solely by test, the testing is conducted


under the most adverse design conditions as determined by analysis. Test results are
reviewed by the responsible technical manager to determine if they verify the design or
design feature(s) tested.

3.7 Design Changes

Design changes, including field changes, are subject to the same design controls and
levels of review as were applicable to the original design. Such changes are
documented, reviewed, approved and incorporated into the design documents as
described in AREVA NP Inc. written procedures. Where a significant design change is
necessary because of an incorrect design, the design process and verification
procedure is reviewed and modified as necessary.

3.8 Engineering Assistance/Advice and Consultation

Certain aspects of AREVA NP Inc. work may include providing engineering manpower
assistance or advice and consultation services at a location designated by a customer.
In such circumstance, the work will be performed under the provisions of the customer’s
QAP unless otherwise authorized by contract.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 4-1

4.0 PROCUREMENT DOCUMENT CONTROL

This section defines procurement document control for safety related items and
services.

For the Design Certification Project, the scope of procurement includes engineering,
design and testing services as well as the procurement of safety-related software. No
equipment or components are being procured as part of the Design Certification Project.

Plant Sector AREVA NP Inc. affiliate companies such as AREVA NP SAS, AREVA NP
GmbH and the AREVA NP Plants Technical Centers, as well as cross sector affiliates
such as the AREVA NP Nuclear Fuel or Jeumont SA are considered suppliers.
Procurement activities with these internal interfacing organizations as well as any
external organizations providing safety-related products or services are conducted in
accordance with Procurement Document Control requirements.

Each organization utilized has been evaluated in accordance with QAP requirements
and maintained on the AREVA NP Inc. Plants and Services Approved Suppliers List.

This section complies with Criterion IV of 10 CFR 50, Appendix B, Procurement


Document Control, and Basic Requirement 4, Procurement Document Control, and the
following supplemental requirements of ANSI/ASME NQA-1-1994 :

4S-1, Supplementary Requirements for Procurement Document Control with the


following clarifications and exceptions:

• Section 2.3 of supplement 4S-1 includes a requirement that procurement


documents require suppliers to have a documented QAP that implements NQA-
1-1994, Part 1. In lieu of this requirement, AREVA NP Inc. may require suppliers
to have a documented supplier QAP that is determined to meet the applicable
requirements of 10 CFR 50, Appendix B, as appropriate to the circumstances of
the procurement.
• With regard to service performed by the supplier, AREVA NP Inc. procurement
documents may allow the supplier to work under the AREVA NP Inc. QA
Program, including implementing procedures, in lieu of the supplier having its
own QAP.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 4-2
4.1 General

Applicable design bases and other requirements necessary to assure adequate quality
shall be included or referenced in documents for procurement of items and services.

4.2 Implementation

4.2.1 Procurement Process

The technical, manufacturing, quality, regulatory, administrative, reporting, and other


requirements prescribed in drawings, specifications, and other documents are
transferred into procurement documents by inclusion in or reference on Purchasing
Authorizations (PA)/Purchase Requisitions (PR). Technical requirements are specified
in the attachments listed on the PA/PR. PA’s/PR’s are prepared, reviewed, and
approved as stipulated in procurement procedures.

The project management function is authorized to procure items and services directly
from other AREVA NP Inc. organizations using a PA as the contract with these
organizations.

Orders placed with external suppliers are processed though AREVA NP Inc.’s
purchasing organization. Purchasing converts the PA/PR into a Purchase Order (PO)
or Change Order (CO). The PO/CO is then sent to the supplier.

QA reviews procurement documents to ensure correct documentation of acceptable


quality requirements, and to determine the need for QA hold/witness points and
surveillance activities.

4.2.2 Procurement Document Content

Procurement documents include or reference the following information and


requirements, as applicable:

• Scope – statement of the work to be performed


• Technical requirements – drawings, specifications, codes, standards, regulations,
procedures, instructions, test and inspection requirements and equipment,
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 4-3
acceptance criteria, and special process instructions for such activities as:
fabrication, inspection, cleaning, packaging, handling, shipping, and storage
• Documentation Requirements – identification of supplier documents and records
to be prepared, maintained, submitted, and made available for AREVA NP Inc.’s
review and/or approval
• QA requirements – identification of quality requirements imposed on the supplier
• Source inspection and audit – identification of source inspection and audit
requirements including the right of access to the supplier’s facilities and records,
and any sub-tier suppliers
• Sub-tier Procurements – extension of applicable procurement document
requirements to lower tier suppliers. AREVA NP Inc. may require the supplier to
use a sub-supplier from the AREVA NP Inc. Approved Supplier List (ASL).
• Nonconformances – requirements for supplier reporting of nonconformances,
and AREVA NP Inc. approval of nonconformances
• Date of submission

4.2.3 Procurement Document Review

Procedures are established for the review of procurement documents by AREVA NP


Inc. QA to determine the quality requirements are correctly stated, inspectable, and
controllable, that there are adequate acceptance and rejection criteria, that the
procurement documents have been prepared, reviewed, and approved in accordance
with QAP requirements, and that the supplier has been evaluated as specified in
Section 7 of this QAP.

AREVA NP Inc. QA has the responsibility and authority to order termination or


suspension of procurement activities when procurement documents conflict with the
requirements of the QAP. Such orders will indicate the action to be taken to allow
resumption or reinstatement of the procurement activity.

4.2.4 Changes to Procurement Documents

Changes to procurement documents are processed in the same manner as the original
procurement documents.

Processing and approval of a supplier nonconformance that deviates from the


procurement document requirements is described in Section 15 of this QAP.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 4-4

Changes made as a result of the bid evaluations or pre-contract negotiations are


incorporated into the procurement documents. The review of such changes and their
effects are completed prior to contract award. Reviews are performed by Purchasing
personnel who have access to the pertinent information and who have an adequate
understanding of the requirements and intent of the procurement documents.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 5-1

5.0 INSTRUCTIONS, PROCEDURES AND DRAWINGS

Section 5.0, Instructions, Procedures and Drawings applies to the Design Certification
Project.

This section complies with Criterion V of 10 CFR 50, Appendix B, Instructions,


Procedures and Drawings, and Basic Requirement 5, Instructions, Procedures and
Drawings of ANSI/ASME NQA-1-1994.

5.1 Purpose

This section defines the controls established by the Company for the control of
procedures, instructions, and drawings that prescribe activities affecting quality.

5.2 General

Measures are established and documented to assure that activities affecting the quality
of items are established in instructions, procedures, or drawings, and accomplished in
accordance with these documents. Instructions, procedures, and drawings shall be
prepared, reviewed, approved, and distributed before beginning the activity.

AREVA NP Inc. QA personnel are included in the documented review and concurrence
of quality-related procedures associated with design, construction and installation.

Instructions and procedures may include the following items, as required:

• Activities falling within the scope of the document,


• Individuals, organizations, or functions who perform the activities,
• Sequencing to aid in the performance of complex activities, and,
• Quantitative and qualitative acceptance criteria (or references which contain the
criteria) to determine the satisfactory accomplishment of defined activities.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 5-2
5.3 Implementation

5.3.1 Administrative Policies, Procedures, and Instructions

The QAP is implemented through this document, and administrative policies,


procedures, and instructions. Policies provide written guidance for the control of
activities and operations of AREVA NP Inc. Administrative procedures, including
Engineering Guidelines, are documents that specify or describe how activities or
operations are performed within AREVA NP Inc. Working Instructions (WI) are on the
same level hierarchically as administrative procedures in function. Operating
Instructions (OI) may be used to describe how activities or operations are performed
within a department.

Approved policies and procedures are filed on the AREVA NP Inc. Intranet website on
Policies and Procedures System (POPS), at Manual Stations, and distributed to others
electronically by Records Management. Alternatively, procedures and other approved
documents may be filed in the AREVA NP Inc.’s Record Management System.
Approved instructions are controlled, distributed, and maintained current by the issuing
organization.

5.3.2 Drawings and Specifications

Drawings and specifications are released for use in engineering, procurement,


manufacturing, and field activities as described in Section 6 of this QAP.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 6-1

6.0 DOCUMENT CONTROL

Section 6.0, Document Control, applies to the Design Certification Project.

This section complies with Criterion VI of 10 CFR 50, Appendix B, Document Control
and Basic Requirement 6, Document Control, and the following supplemental
requirements of ANSI/ASME NQA-1-1994:

• 6S-1, Supplementary Requirements for Document Control

6.1 Purpose

This section defines the system of controls for the preparation, review, approval,
revision, distribution, and use of documents that prescribe activities affecting quality.

6.2 General

Company procedures and instructions detail the methods for preparation, review,
approval, revision, distribution, and use of documents. In addition, procedures govern
the coordination and control of interface documents. Interface documents may include
those between engineering disciplines, engineering projects, affiliate companies,
suppliers, or customers.

The following types of documents are controlled within the document control system:

• Quality Documents – includes administrative documents, AREVA NP Inc. QAP’s,


nonconformance documents, and procedures describing activities affecting
quality (refer to Sections 0, 5 and 15 of this QAP)
• Design Documents – includes calculations, drawings, specifications, analyses,
computer codes, and documents related to software (refer to Sections 3 and 5 of
this QAP)
• Technical Documents – includes inspection, field, test, and special processes
procedures and documents (refer to Sections 5, 9, and 11 of this QAP)
• Procurement Documents (refer to Section 4 of this QAP)
• Manufacturing Documents (refer to Sections 5, 9 and 11 of this QAP)
• Construction Documents (refer to Sections 5, 8, 9, and 11 of this QAP)
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 6-2
6.3 Implementation

6.3.1 Document Control System

Measures are established to assure that documents are reviewed for adequacy and
approved for release by authorized personnel to individuals and locations requiring the
documents for work activity. The document control function also provides for the
following:

• Updating Policies and Procedures System (POPS – Intranet site which contains
implementing documents), master document lists, control logs, or other means
used to identify the current status and revision level of documents
• Accumulating, protecting, and storing AREVA NP Inc., supplier, or customer
documentation
• Coordinating and controlling interface documents

6.3.2 Document Change Control

Changes and revisions to the documents listed in Section 6.1 shall have at least the
same review and approval as the original document. If the original organization no
longer exists or is no longer responsible, another qualified organization may approve
changes and revisions.

6.3.3 Release of Documents

Documents such as drawings, specifications, and calculations are released using


Document Release Notices (DRN), or Applicable Document Lists (ADL). DRN’s and
ADL’s are prepared and approved by designating personnel as prescribed by
administrative procedures. Computer programs are released for use upon completion
of their certification process as defined in procedures. Superseded documents are
controlled by Records Management. Documents are distributed to and used by
personnel performing quality related work.

6.3.4 Supplier Prepared Documents

Documents prepared by suppliers (drawings, design reports, procedures, etc.) are


received by Purchasing or the project management function.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 6-3

The reviewer prepares a Document Comment Form (DCF) indicating the review status
of the document. A document number is obtained from the applicable AREVA NP Inc.’s
Records Management database by the document owner. If the document is not
approved, it is returned to the supplier with an explanation of corrections to be made.

If the document is approved, it is sent to the customer for review and approval when
required by contract.

Resolved customer comments are sent to the supplier for document revision.

6.3.5 Customer Prepared Documents

For customer originated documents, the cognizant engineer records the comments in a
memo and forwards it to the customer via the project management function. On
approval of the document, a DCF is prepared by the cognizant engineer and released to
Records Management for entry into the Contract Documents List.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 7-1

7.0 CONTROL OF PURCHASED MATERIALS, ITEMS, AND SERVICES

The scope of procurement for the Design Certification Project includes engineering,
design and testing services, as well as the procurement of safety-related software. No
equipment or components are being procured as part of the Design Certification Project.

Therefore, for the Design Certification Project, the controls associated with this section
apply to the control of the applicable services only.

This section complies with Criterion VII of 10 CFR 50, Appendix B, Control of
Purchased Material, Equipment and Services and Basic Requirement 7, Control of
Purchased Items and Services, and the following supplemental requirements of
ANSI/ASME NQA-1-1994:

• 7S-1, Supplementary Requirements for Control of Purchased Items and Services


with the following clarifications and exceptions:
- AREVA NP Inc. considers that the Authorized Nuclear Inspection Agencies,
National Institute of Standards and Technology, or other State and Federal
agencies which may provide items or services are not required to be
evaluated or audited.
- When purchasing commercial grade calibration services from a calibration
laboratory, procurement source evaluation and selection measures need not
be performed provided each of the following conditions are met:
(1) The purchase documents impose any additional technical and
administrative requirements, as necessary, to comply with the AREVA NP
Inc. QA program and technical provisions. At a minimum, the purchase
document shall require that the calibration certificate/report include
identification of the laboratory equipment/standard used.
(2) The purchase documents require reporting as-found calibration data when
calibrated items are found to be out-of-tolerance.
(3) A documented review of the supplier's accreditation shall be performed
and shall include a verification of each of the following:
• The calibration laboratory holds a domestic Accreditation by the
National Voluntary Laboratory Accreditation Program (NVLAP) or by
the American Association for Laboratory Accreditation (A2LA) as
recognized by NVLAP through the International Laboratory
Accreditation Cooperation (ILAC) Mutual Recognition Arrangement
(MRA).
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 7-2
• The accreditation is based on ANS/ISO/IEC 17025.
• The published scope of accreditation for the calibration laboratory
covers the necessary measurement parameters, ranges, and
uncertainties.

7.1 Purpose

This section governs the control of purchased safety related materials, items, and
services including source evaluation and selection, source inspection, and receiving
inspection in accordance with regulatory and contract requirements.

7.2 General

The control of purchased safety related materials, items, and services are in
accordance with written procedures and instructions. AREVA NP Inc. QA audits the
capability of suppliers of safety related materials, items, and services and maintains a
list of approved suppliers.

7.3 Supplier Evaluation and Selection

The acceptability of suppliers of safety related materials, items, or services are based
on the following items:

• A direct evaluation of their QA Program to 10 CFR 50 Appendix B and NQA-1 to


determine the capability to supply materials, items, or services meeting all
procurement document requirements
• A survey/audit of the supplier’s facility

Suppliers are required to ensure that their products meet the requirements of the
procurement documents. These methods are reviewed by the cognizant
Manager/Supervisor with an overview by the QA organization. Additionally, AREVA NP
Inc. may verify acceptance of products by independent analysis.

The AREVA NP Inc. acceptance of products by independent analysis is applicable only


to the suppliers of ASME materials from suppliers that have not been audited by
AREVA NP Inc. but who hold ASME Certificates. AREVA NP Inc. would conduct
independent analysis prior to acceptance of the material. This method is not applicable
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 7-3

to the Design Certification as no materials are being procured in the scope of the
project.

Reviews of the vendor quality program, performance of audits, performance of pre-


award evaluations and annual evaluations are performed in accordance with an
administrative procedure which follows the guidance of Regulatory Guide 1.28 and
1.144; these methods are used to verify the quality of the products and services
provided by subcontractors/sub-vendors. As part of this program subcontractors/sub-
vendors are required to furnish documents such as QA Data Packages, procedures,
source audit and surveillance reports, and QAP documents. Sub-vendor/subcontractor
QAP’s are reviewed and accepted during the pre-award evaluation of the sub-vendor/
subcontractor prior to placement on the Approved Suppliers Listing (ASL).

Suppliers passing an audit by an AREVA NP Inc. affiliate may be accepted by QA as a


supplier of safety related materials, items, and/or services. QA will review the audit
checklist, auditor qualifications, and audit reports to assure conformance with AREVA
NP Inc. requirements. A copy of the audit report, audit checklist, resolution to any
deficiencies, and auditor qualification is maintained in the QA audit files.

QA also participates in a shared audit program through the Nuclear Industry


Assessment Committee (NIAC). NIAC shares the results of supplier audits among
industry companies, reducing the supplier’s number of external audits. Audit checklists,
auditor qualifications, resolution to any deficiencies, and audit reports are reviewed to
assure conformance to AREVA NP Inc. requirements.

7.3.1 Dedication of Commercial Grade Items and/or Services

Commercial grade items and/or services for safety related applications may be procured
from suppliers where specific quality controls for nuclear applications cannot be
imposed in a practical manner. In these instances, an evaluation of the suitability of the
item or service for nuclear applications is performed by the responsible technical
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 7-4

manager and quality organization. The critical characteristics of the item or service are
also determined and documented as part of this evaluation. Special methods shall be
established by the responsible technical manager and quality organization to provide
assurance that the item or service specified is the item or service received. If needed,
these special quality verification methods may include inspections, tests, commercial
grade surveys, or evaluations of the supplier. Suppliers of commercial grade items
and/or services need not appear on the ASL.

7.4 Approved Supplier List (ASL)

Procedures control the maintenance of the ASL. Suppliers meeting the criteria
described in Section 7.3 are included in the ASL issued by the Manager of Quality
Audits and Programs for safety related items and services.

Procurement selects suppliers from this list for placement of orders that impose safety
related requirements and are capable of providing the types of items/services in
accordance with the requirements of the procurement documents. With Project
Management and QA approval, suppliers not on the ASL may be selected in situations
where unique products or services are needed. These suppliers may be utilized, as
described above, provided work is conducted under applicable portions of the AREVA
NP Inc. QA program at the supplier’s location and provided AREVA NP Inc. Quality
performs 100% surveillance of the supplier’s activities. Requirements to perform
surveillance are determined by QA and/or the responsible technical manager.

On an individual basis and at the direction of the customer, AREVA NP Inc. will use a
customer approved supplier; however, the supplier will not be placed on the ASL.

Suppliers of items and/or services remain on this list as long as they maintain
acceptable quality performance standards and they continue to satisfy the audit criteria.

7.5 Procurement Process Monitoring

Procurement documents are reviewed by QA as described in Section 4 of this QAP.


AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 7-5
7.6 Item/Service Verification

Source inspections or surveillances are performed as required by the written criteria of


the procurement documents. The inspection/surveillance requirements in the
procurement documents indicate the AREVA NP Inc. inspection, witness, and/or hold
points, as well as any customer designated hold and/or witness points.

7.6.1 Receiving Inspection

Incoming items received by AREVA NP Inc. at its own facilities or at a plant site for use
in safety related applications undergo receiving inspection by inspection personnel prior
to the release of such items for further processing. Receipt inspectors shall perform
receipt inspections of material in accordance with Working and Operating Instructions to
ensure compliance with procurement documents. Receiving inspections may be
conducted on an individual item or sampling basis.

Concurrent with the receiving inspection, QA verifies that all supplier documentation
required by the procurement documents has been reviewed by the appropriate
organizations for completeness and compliance with requirements. The inspection
status of accepted items and material is identified per Section 8.

7.7 Supplier Nonconformances

Nonconformances detected during an inspection or surveillance are processed in


accordance with Section 15.3 of this QAP. The inspection report notes
nonconformances dispositioned as repair or use-as-is. The supplier submits a written
request to AREVA NP Inc. for disposition approval as required by Section 15.4 of this
QAP.

7.8 Certifications of Conformance (CoC/QA Data Packages)

For items designed by AREVA NP Inc. and manufactured within AREVA NP Inc. or by
suppliers, the project management function furnishes the customer with a QA Data
Package that provides objective evidence that the materials and items meet the
requirements of the customer’s order. As a minimum, the QA Data Package consists of
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 7-6

a CoC signed by the responsible QA representative. Other supporting documentation


may be included as required by the customer’s order.

CoC’s for the assembly, repair, modification, or testing of safety related items are
processed as described in written procedures. AREVA NP Inc. procedures for QA Data
Packages and CoCs contain provisions that establish the minimum acceptable list of
criteria for documentary evidence that items and/or services procured from suppliers or
from within AREVA NP Inc. conform to procurement document requirements and that
those criteria are provided on the CoC. As a minimum, a stand alone CoC details and
attests to the following, if applicable:

• Customer/ Plant Site


• AREVA NP Inc. QADP package number
• Customer PO Number and Change Order Number
• AREVA NP Inc. Contract No.
• Item identification
• Description of item or service provided
• Technical Documents
• Equipment Code Class and reference made to AREVA NP Inc. Certificate (for
ASME supplied materials only)
• Applicable QA program identification and revision number
• Non-Conformances or exceptions to PO
• Non-conformances resolved
• Revision of CoC and description of revision
• General statements of compliance to applicable codes, standards, tests and
quality assurance requirements
• Acceptance signature by AREVA NP Inc. Quality Representative (for ASME and
safety related CoC only)

CoC’s are signed by the Vice President, Quality & Performance or designee.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 8-1

8.0 IDENTIFICATION AND CONTROL OF ITEMS AND MATERIALS

Based on the types of procurements previously stated for the Design Certification
Project, the scope of the project does not include the identification and control of
material, parts and components.

This element is therefore not applicable to the Design Certification Project.

However, this section does comply with Criterion VIII of 10 CFR 50, Appendix B,
Identification and Control of Materials, Parts and Components and Basic Requirement
8, Identification and Control of Items, and the following supplemental requirements of
ANSI/ASME NQA-1-1994:

• 8S-1, Supplementary Requirements for Identification and Control of Items

8.1 Purpose

This section defines the measures used to ensure the preparation and use of written
procedures for identification and control of safety related materials and items, and to
ensure that only correct and accepted items are used or installed.

8.2 General

Procedures are established by AREVA NP Inc. for the identification and control of items
to assure that:

• Only correct and accepted items are used. Nonconforming items are identified
and segregated from acceptable items.
• Identification and traceability of items is maintained from receipt through storage,
processing, and assembly to final acceptance of complete items.
• Correct identification of items is verified and documented prior to release for
fabrication, assembly, or shipment.
• Identification of items can be traced to applicable documentation such as
drawings, specifications, procurement documents, manufacturing and inspection
documents, nonconformance reports, and mechanical and chemical test reports.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 8-2
• Items are identified by heat number, part number, serial number, lot number, or
other unique identifiers as applicable, either on the item or on records traceable
to the item.
• Identification methods used are not detrimental to the item.
• Physical identification is used whenever possible. Where physical identification
is either impractical or insufficient, physical separation, procedural controls, or
other means are employed.
• Identification markings are transferred to each piece or lot prior to subdivision.

Specific identification such as task, group, sequence numbers, or part numbers are
assigned as applicable by the responsible AREVA NP Inc. organizations to safety
related items supplied by AREVA NP Inc. These numbers are used to identify the items
and for the association of documents to the items for which they are applicable.

8.3 Implementation

The identification of items manufactured by AREVA NP Inc. is established using the


identification requirements contained in drawings, specifications, customer orders,
and/or internal procedures. Control and traceability are maintained by procedures
covering the manufacturing, inspection, and field operations in accordance with the
requirements of Section 8.2 of this QAP. Suppliers may use the AREVA NP Inc.
assigned identification numbers in conjunction with their own identification system
during design, procurement, fabrication and shipping. Suppliers using their own
identification and control systems must be able to demonstrate traceability to the
AREVA NP Inc. assigned identification number.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 9-1

9.0 CONTROL OF SPECIAL PROCESSES

The scope of the design certification project does not include fabrication, erection,
installation or use.

This element is therefore not applicable to the Design Certification Project.

However, this section complies with Criterion IX of 10 CFR 50, Appendix B, Control of
Special Processes and Basic Requirement 9, Control of Processes, and the following
supplemental requirements of ANSI/ASME NQA-1-1994:

• 9S-1, Supplementary Requirements for Control of Processes

9.1 Purpose

This section defines the manner in which AREVA NP Inc. ensures that procedures are
established and used to control special processes for safety related items.

9.2 General

Special processes include but are not limited to welding, heat treating, and
nondestructive examination (NDE). Cleaning is considered to be a special process with
exceptional and unusual care in cleaning is necessary as defined in the applicable
drawings and specifications. Written procedures establish the requirements for the
control of special processes used by AREVA NP Inc.

9.3 Implementation

Special processes may be subcontracted to qualified suppliers (refer to Sections 4 and


7) or performed by AREVA NP Inc.

AREVA NP Inc. special processes are controlled to ensure the following:

• Special processes are performed in accordance with qualified, approved


procedures using approved methods and materials, utilizing personnel and
equipment qualified in accordance with applicable codes and/or standards.
• Records of procedures, processes, operators, and equipment qualifications and
approvals are maintained and available for review.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 9-2
• Special processes are accomplished with written process sheets, shop
procedures, checklists, travelers, computerized tracking, or equivalent that
provide adequate methodologies for recording evidence of verification.

9.3.1 Welding

Written procedures or instructions govern the methods used to qualify welding


procedures and personnel in accordance with applicable codes and standards. The
cognizant welding engineer is responsible for the qualification of welding procedures,
welders, and welding operators.

After qualification, welding procedures are released for use as described in Section 6 of
this QAP. In addition, they are released for specific applications by reference in
travelers, fabrication routing documents, manufacturing procedures, or field procedures
as discussed in Section 6 of this QAP.

The assignment of qualified welders and welding operators to specific jobs is the
responsibility of the welding supervisors. The welding supervisors assure that the
specified welding procedures are available, that the welding personnel are properly
qualified, and that welding is performed as specified in written procedures or
instructions.

All welded joints are traceable to the welder(s) or welding operators who performed the
welding operations via at least one of these methods: traveler, manufacturing
procedure, field procedure, or weld control record. The initiating and dating of the
traveler, fabrication routing document, or procedures (at the appropriate sequences)
and the weld control record by welding personnel or welding supervisor provides this
traceability.

9.3.2 Heat Treatment

Heat treatment of base material and welds is subcontracted to qualified personnel or


may be performed by AREVA NP Inc. (refer to Sections 4 and 7).
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 9-3

Preheat, interpass, and post weld heat temperature requirements for welding processes
performed are specified in the welding procedures discussed in Sections 9.3.1 of this
QAP.

Post-weld heat treatments performed by AREVA NP Inc. are controlled by procedures


prepared by the responsible engineering organization. These procedures are released
for use as described in Section 6 of this QAP. In addition, they are released for specific
AREVA NP Inc. shop or field applications by reference in travelers, manufacturing
procedures, or field procedures as discussed in Section 5 of this QAP.

9.3.3 Nondestructive Examination (NDE)

9.3.3.1 NDE Personnel Qualification

Personnel performing NDE are qualified to written practices (applicable NDE Personnel
Qualification Procedure) in accordance with the ASME Code and SNT-TC-1A/CP-189
(latest version accepted by the ASME Code) by the appropriate Company NDE
Certification Administrator. Records of personnel qualification including the Level III
certifications are maintained by AREVA NP Inc. NDE Services.

NDE personnel and equipment may be contracted from AREVA NP Inc. approved NDE
suppliers.

9.3.3.2 NDE Procedures

NDE procedures used by AREVA NP Inc. in the examination of items are reviewed and
approved by an appropriate AREVA NP Inc. Level III and are qualified by demonstrating
that the technique detailed in the procedure is capable of detecting the targeted
discontinuities.

NDE procedures are released for use as described in Section 6 of this QAP. They are
released for specific AREVA NP Inc. shop or field applications by reference in travelers,
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 9-4

fabrication routing documents, manufacturing procedures, or field procedures as


described in Section 5 of this QAP.

The results of nondestructive examinations, as required by the applicable codes and


standards, are recorded on inspection records or other related documents as defined in
written procedures or instructions.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 10-1

10.0 INSPECTION

The scope of the Design Certification Project does not include fabrication, erection,
installation or use. No equipment or components are being procured as part of the
Design Certification Project.

This element is therefore not applicable to the Design Certification Project.

However, this section complies with Criterion X of 10 CFR 50, Appendix B, Inspection,
and Basic Requirement 10, Inspection, and the following supplemental requirements of
ANSI/ASME NQA-1-1994:

• 10S-1, Supplementary Requirements for Inspection

10.1 Purpose

This section establishes the elements of the QAP required for inspection activities
affecting safety related items.

10.2 Scope

This section applies to all safety related items requiring inspection. Inspections required
to verify conformance of an item or activity to specified requirements shall be planned
and executed. For Nondestructive Examination (NDE) inspections, refer to Section 9.

10.3 General

Inspections shall be performed by qualified personnel in accordance with standards and


AREVA NP Inc. written procedures. Inspection personnel are independent from the
individual or group performing the activity being inspected. Inspection procedures,
applicable drawings, travelers, and specifications define inspection criteria, identify
mandatory inspection hold and witness points, and verify acceptable calibration
equipment status. Inspection results are documented, evaluated, and accepted based
on the acceptance criteria specified in the applicable document.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 10-2
10.4 Implementation

10.4.1 Inspection Types

Source and receiving inspections are covered in Section 7 of this QAP.

In-process and final inspections are, when necessary, performed in accordance with
instructions, procedures, drawings, checklists, travelers, or other appropriate means.
Inspection requirements may also be identified in surveillance requirement documents
or procurement specifications for AREVA NP Inc. or suppliers’ shops and to designate
customer hold or witness points.

10.4.2 Inspection Plan

Planning for inspection activities shall be accomplished and documented. The


documentation shall identify characteristics, methods, and acceptance criteria, and shall
provide for recording objective evidence of inspection results.

Indirect control (by monitoring processing methods, equipment and personnel), is


provided when direct inspection of processed items is impractical or dangerous. Both
inspections and process monitoring are provided when control is inadequate without
both.

10.4.3 Inspection Result

Inspection records include the following information: identification of item inspected,


date, inspection, type of observation, results, acceptability, and reference to actions
taken on nonconformances. An inspector’s initials (or signature) and date at the
inspection sequence on the traveler, in the manufacturing/field procedure, or the
surveillance/QC inspection report, with the item’s status (accepted or rejected), are
used to document the results of inspections. Inspection status is discussed in Section
14 of this QAP and used by inspection personnel to verify completion of the inspection
operations. Nonconforming conditions require completion of a Condition Report (CR)
as described in Section 15 of this QAP.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 10-3
10.4.4 Review of Completed Inspection Documentation

QA reviews completed inspection documents and verifies the following information: all
sequences were properly certified and signed off, Condition Reports were reviewed,
dispositioned, and resolved, and required inspections were documented.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 11-1

11.0 TEST CONTROL

The scope of the Design Certification Project does not include fabrication, erection,
installation or use.

Testing and test control associated with proof tests prior to installation, preoperational
tests, and operational tests during plant operations are therefore not applicable to the
Design Certification Project.

Test Control is applicable to tests and testing programs associated with design
verification of the EPR. Tests may be conducted by AREVA NP Inc. or by qualified,
approved suppliers. The requirements for such tests are included in test requirements
documents prepared by the responsible technical manager. These test requirement
documents include, as appropriate, the requirements of this section of the QAP, scope
of the test, technical requirements, and QA requirements.

Computer programs used for design analyses are certified or verified and validated as
required. Computer Program Testing is addresses in Section 3, Design Control, of the
QAP.

This section complies with Criterion XI of 10 CFR 50, Appendix B, Test Control, and
Basic Requirement 11, Test Control, and the following supplemental requirements of
ANSI/ASME NQA-1-1994:

• 11S-1, Supplementary Requirements for Test Control


• 11S-2, Supplementary Requirements for Computer Program Testing

11.1 Purpose

This section applies to the testing of safety related items that are required to
demonstrate compliance with regulatory and contract requirements.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 11-2
11.2 General

When engineering judgment, codes, standards, regulations, or specifications indicate


that testing is required, a written test program is established via test requirement
documents by the responsible technical manager to ensure conformance with those
requirements. In those cases where design is the responsibility of the AREVA NP Inc.
suppliers, the requirements for written test programs are imposed on those suppliers
through procurement documents.

The test program describes required tests, such as prototype qualification tests or
design verification tests, to demonstrate that the item will perform satisfactorily in
service. Whenever engineering judgment leads to the conclusion that design analysis
or previous experience cannot substantiate a design or design feature, design
verification testing is conducted as described in this section and Section 3.6 of this
QAP.

11.3 Implementation

Tests may be conducted by AREVA NP Inc. or by qualified, approved suppliers. The


requirements for such tests are included in test requirements documents prepared by
the responsible technical manager. These test requirement documents include, as
appropriate, the requirements of this section, scope of the test, technical requirements,
and QA requirements.

The test requirement documents require testing to be performed in accordance with


written test plans and/or procedures that incorporate or reference the design
requirements and acceptance limits contained in the applicable design documents. The
test plans and/or procedures for tests performed by AREVA NP Inc. are prepared by the
responsible technical manager and those for tests at suppliers are prepared by the
supplier and approved by the responsible technical manager as defined in Section 6 of
this QAP.

These plans or procedures provide instructions for performing the test(s) and include
provisions for ensuring that prerequisites for the given tests are complied with, hold and
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 11-3

witness points are included, testing methods are provided, acceptance and rejection
criteria is defined, adequate and calibrated instrumentation is used, testing is performed
under suitable environmental conditions by trained personnel, necessary monitoring is
performed, and provisions are provided for data acquisition, collection and storage.

Test results are documented, evaluated, and their acceptability determined by the
responsible technical manager to ensure that the test requirements have been met.

Test records, at a minimum, identify the item tested, date of test, tester or data recorder,
type of observations, results and acceptability, action taken in connection with any
deviations noted, and person evaluating test results.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 12-1

12.0 CONTROL OF MEASURING AND TEST EQUIPMENT

The scope of the design certification project does not include fabrication, erection,
installation or use.

The control of M&TE associated with proof tests prior to installation, preoperational
tests, and operational tests during plant operations is therefore not applicable to the
Design Certification Project.

However, the control of M&TE associated with tests and testing programs utilized for
design verification of the EPR are applicable to the project and to organizations that
have conducted such tests.

This section complies with Criterion XII of 10 CFR 50, Appendix B, Control of Measuring
and Test Equipment, and Basic Requirement 12, Control of Measuring and Test
Equipment, and the following supplemental requirements of ANSI/ASME NQA-1-1994:

12S-1, Supplementary Requirements for Control of Measuring and Test Equipment with
the following clarifications and exceptions:

• The out of tolerance conditions described in paragraph 3.2 of supplement 12S-1


refers to when the Measuring and Test Equipment (M&TE) is found out of the
required accuracy limits. (i.e., out of tolerance) during calibration.
• M&TE are not required to be marked with a calibration status where it is
impossible or impractical due to equipment size or configuration (such as the
label will interfere with operation of the device) provided the required information
is maintained in suitable documentation traceable to the device.

12.1 Purpose

This section establishes the elements of measuring and test equipment (M&TE) control
as required by regulatory requirements.

12.2 General

Measures are established and documented to assure that tools, gages, instruments,
and other M&TE used in construction, fabrication, testing, examination, or inspection
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 12-2

activities affecting quality are of the range, type, and accuracy to verify conformance to
established requirements. These measures are based upon the requirements of MIL-
STD 45662A, “Calibration System Requirements,” and ANSI/NCSL Z540-1, “Calibration
Laboratories and M&TE General Requirements.”

12.3 Implementation

12.3.1 Procedures

Calibration procedures are prepared to define the method of calibration, means of


identification, recalibration frequency, reference and transfer standards, and recall of
subject or damaged M&TE. Calibration procedures are prepared to define the method
of calibration, means of identification, recalibration frequency, reference and transfer
standards, and recall of subject or damaged M&TE. Calibration procedures are further
prepared to assure M&TE are calibrated and adjusted at prescribed intervals or prior to
use against certified equipment having known valid relationships to nationally
recognized standards. If no nationally recognized standards exist, the bases for
calibration are documented.

Procedures concerning suspect M&TE are also generated to describe removal from
service, methods for tagging and segregating, and requirements for recalibration. If the
M&TE is found to be out of tolerance, an evaluation of previous inspection or test results
shall be performed and documented to determine the acceptability of items inspected
and tested using the defective equipment.

12.3.2 Control of M&TE

M&TE is controlled through an identification system traceable to calibration records.


Calibration records indicate the last calibration date and the due date. The calibration
due date is displayed on or attached to each piece of M&TE or on records traceable to
each item. These calibration requirements do not imply a need for special calibration
and control measures of rulers, tape measures, levels, and other devices where
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 12-3

commercial accuracy is adequate. These devices shall be visually inspected to assure


that damage or deterioration has not impaired their accuracy.

Reference standards are either marked with calibration labels to indicate the next due
date for calibration, or the calibration information is contained in records traceable to the
reference standard.

User organizations shall be responsible for assuring that M&TE used in activities
affecting quality are properly controlled and calibrated to maintain accuracy within
necessary limits. User organizations shall also assure that proper procedures are
followed for gages, measuring devices, and inspection fixtures used to verify and certify
item conformance with specified requirements. Production tooling or fixtures used as
an acceptance inspection method are also subject to the M&TE control program.

12.3.3 M&TE Suppliers and M&TE Calibration Services

Suppliers of M&TE and calibration services for M&TE and reference standards are
required by the procurement documents to have an effective system for the calibration
of M&TE. Suppliers of calibration services used to calibrate M&TE or reference
standards are audited and approved by AREVA NP Inc. QA as described in Sections 7
and 18 of this QAP. State and federal agencies such as the National Institute of
Standards and Technology (NIST) are exempted from this requirement. Other
methods, such as NAVLAP and A2LA, may be used to approve M&TE suppliers
provided the following conditions are satisfied:

For procurement of commercial-grade calibration services for safety-related


applications, laboratory accreditation programs administered by the National Institute of
Standards and Technology and by the American Association for Laboratory
Accreditation, as recognized through the mutual recognition arrangement of the
International Laboratory Accreditation Program (ILAC), are acceptable in lieu of a
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 12-4

supplier audit, commercial-grade survey, or in-process surveillance provided that all of


the following conditions are met:

a. The alternative method is documented in the QA program description.


b. Accreditation is to ANSI/ISO/IEC 17025, "General Requirements for the
Competence of Testing and Calibration Laboratories."
c. Use of the alternative method is limited to the National Voluntary
Accreditation Program and the American Association for Laboratory
Accreditation, as recognized by ILAC signatories.
d. The scope of the accreditation covers the contracted services.
e. Purchase documents impose additional technical and administrative
requirements to satisfy necessary QA program and technical requirements.
f. Purchase documents require reporting as-found calibration data when
calibrated items are found to be out-of-tolerance.
g. Purchase documents require identification of the laboratory
equipment/standards used.
h. The alternative method is limited to the domestic calibration service suppliers.

The alternative method is applicable to subsuppliers of calibration service suppliers,


provided the above conditions are met.

Alternatively, the acceptability of calibration services performed by an unaudited


supplier may be confirmed/verified by performing surveillance while the item is being
calibrated. The supplier must show traceability to NIST or to a nationally recognized
standard when no NIST standard exists. If the supplier finds the item to be within
calibration, then the item is acceptable for use. The calibration is documented by
AREVA NP Inc. QA/QC; the supplier does not need to be audited by AREVA NP Inc.
QA.

12.3.4 Customer Furnished M&TE

Customer furnished M&TE may be used by AREVA NP Inc. in performing


measurements/tests provided that the customer provides written authorization and
supplies a copy of the calibration certification.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 13-1

13.0 HANDLING, STORAGE, AND SHIPPING

The scope of the Design Certification Project does not include fabrication, erection,
installation or use.

This element is therefore not applicable to the Design Certification Project.

However, this section complies with Criterion XIII of 10 CFR 50, Appendix B, Handling,
Storage and Shipping, and Basic Requirement 13, Handling, Storage and Shipping and
the following supplemental requirements and subparts of ANSI/ASME NQA-1-1994:

• 13S-1, Supplementary Requirements for Handling, Storage and Shipping

The following subparts apply to scopes of work provided at plant sites or AREVA NP
Inc. facilities. (These subparts do not apply to the scope of the Design Certification
Project)

• Subpart 2.1, “Quality Assurance Requirements for Cleaning of Fluid Systems and
Associated Components for Nuclear Power Plants”
• Subpart 2.2, “Quality Assurance Requirements for Packaging, Shipping,
Receiving, Storage, and Handling of Items for Nuclear Power Plants”
• Subpart 2.15, “Quality Assurance Requirements for Hoisting, Rigging, and
Transporting Items for Nuclear Power Plants”
13.1 Purpose

This section describes the methods for handling, storing, and shipping safety related
items.

13.2 General

Operations concerning special handling, storage, cleaning, packaging, and shipping


requirements shall be in accordance with AREVA NP Inc. procedures. These
procedures shall contain accepted practices to prevent damage or deterioration of
components. Special protective environments, such as inert gas atmospheres, specific
moisture content levels, and temperature levels are specified and provided, as
necessary. Customer and supplier specified requirements shall be used as a basis for
AREVA NP Inc. handling, storage, and protection requirements.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 13-2
13.3 Implementation

13.3.1 Cleanliness

Cleaning operations at AREVA NP Inc. divisions are performed by appropriately trained


personnel in accordance with written procedures which incorporate the requirements of
applicable standards, drawings, or specifications. Measures are taken during
fabrication and storage to preclude damage, loss, or deterioration.

Final assembly operations are performed in areas which permit the attainment of the
final cleanliness level specified in the applicable drawings and specifications. After
completing final inspections, the cleanliness of accepted items is maintained to ensure
compliance with the applicable cleanliness requirements.

13.3.2 Storage

Acceptable items are tagged and placed, as necessary, in designated storage areas.
Items in long term storage areas are periodically inspected for damage to the item or its
packaging.

13.3.3 Packaging

Packaging of acceptable items for shipment from AREVA NP Inc. divisions is performed
as required by the applicable drawings or specifications.

13.3.4 Handling

Major items are handled in such a manner as to preclude damage. Handling devices
used for lifting or transporting major items must undergo periodic load test as prescribed
in written procedures.

13.3.5 Shipping

Items shall be transported according to the proper protection classification and


packaging methods.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 14-1

14.0 INSPECTION, TEST, AND OPERATING STATUS

The scope of the design certification project does not include fabrication, erection,
installation or use.

This element is therefore not applicable to the Design Certification Project.

This section complies with Criterion XIV of 10 CFR 50, Appendix B, Inspection, Test
and Operating Status and Basic Requirement 14, Inspection, Test, and Operating
Status, of ANSI/ASME NQA-1-1994.

14.1 Purpose

This section defines methods ensuring that measures are taken to indicate the
inspection, test, and operation status of safety related items.

14.2 General

Systems are established and implemented via AREVA NP Inc. procedures for the
control of inspection, test, and operating status of items. The systems contain
provisions for:

• Documenting and identifying items that have satisfactorily passed required


inspections and tests
• Precluding inadvertent bypassing of inspection and test requirements
• Providing inspection and test status indicators such as stamps, tags, labels, route
cards, and shop travelers
• Controlling the application and removal of status indicators and identifying the
source of authority required for such actions
• Controlling and documenting the bypassing of required inspections, tests, or
other critical operations when dictated by circumstances
• Ensuring that personnel concerned with production or cost control will not
exercise control over the application or removal of status indicators
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 14-2
14.3 Implementation

14.3.1 Status Indication by Travelers or Manufacturing/Field Procedures

The status of fabrication, assembly, inspection, test or field operations for items
processed by AREVA NP Inc. at its facilities or in the field are indicated on travelers or
in manufacturing/field procedures.

Inspection sign-offs on travelers, fabrication routing documents, or manufacturing/field


procedures are as described in Section 10 of this QAP. Inspectors also verify that
operations subsequent to the last inspection operation have been properly initialed and
completed.

Completed travelers, fabrication routing documents, or manufacturing/field procedures


are reviewed by QA as specified in Section 10 of this QAP.

14.3.2 Status Indication by Tags

Tags are attached, as described in AREVA NP Inc. instructions and procedures, by the
inspector(s) to items or their containers indicating successful completion of receipt or
final inspection. Items not in compliance and rejected items are tagged and segregated
from conforming items. Items found to be acceptable during in-process inspection are
noted on the traveler, fabrication routing document, or manufacturing/field procedure
and tags are not used.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 15-1

15.0 CONTROL OF NONCONFORMING ITEMS

The scope of the design certification project does not include fabrication, erection,
installation or use.

Nonconforming materials, parts, or components are not applicable to the Design


Certification Project.

Nonconformities associated with services or documentation are processed in


accordance with this section of the QAP under the AREVA NP Inc. Corrective Action
Program.

This section complies with Criterion XV of 10 CFR 50, Appendix B, Nonconforming


Materials, Parts, or Components, and Basic Requirement 15, Control of Nonconforming
Items, and the following supplemental requirements of ANSI/ASME NQA-1-1994:

• 15S-1, Supplementary Requirements for the Control of Nonconforming Items

15.1 Purpose

This section applies to safety related materials and items, and their supporting
documentation. It addresses characteristics, documentation, or procedure deficiencies
that render an item or activity unacceptable or indeterminate.

15.2 General

Measures are established to control documentation and items that do not conform to
specified requirements. Specific requirements include procedures for controlling the
identification, documentation, and segregation of nonconforming items pending
notification of affected individuals and/or organizations, review of the nonconformance,
and approval of disposition. Internal and external Condition Report dispositions are
submitted for customer approval as required by the contract or purchase order.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 15-2
15.3 Internal Nonconformances

Certain nonconformances may be generated with AREVA NP Inc. as a result of


inspections, internal audits, customer audits, customer problems/complaints, or other
deficiencies. These nonconformances are documented and resolved through the use of
the following reports:

15.3.1 Nonconformances

Nonconforming items detected during receiving, in-process, or final inspections at


AREVA NP Inc. facilities or in the field are tagged as described in Section 14 and
documented on a Condition Report (CR).

Personnel performing evaluations to determine a disposition have demonstrated


competence in the specific area they are evaluating, have an adequate understanding
of the requirements, and have access to pertinent background information.

Condition Reports are submitted as necessary to the responsible engineering


organization for review and determination of cause, corrective action, and disposition.
Disposition and subsequent actions may be rework, repair, use-as-is, or scrap and
replace. Definitions of rework, repair, and scrap are contained in Appendix C.
Rework/repair activities are performed in accordance with approved methods or
procedures and re-inspected to the original criteria or to criteria established for the
acceptability of rework or repair.

Condition Reports are issued also when a significant condition adverse to quality exists,
a quality deficiency is recurring and/or where other means of obtaining corrective action
have proved ineffective in resolving a problem; these Condition Reports are considered
a Significance Level 1 or 2. Level 1 and 2 Conditions Reports are used to emphasize
that the cause of a problem be determined and action taken to preclude its recurrence.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 15-3
15.3.2 Safety Concerns

Nonconformances which may constitute potential significant deficiencies or substantial


safety hazards are processed as preliminary safety concerns in accordance with written
procedures. Safety concerns are processed to the requirements of 10 CFR 21.

15.3.3 Audit Findings (AF)

Internal and external audits may result in audit findings as described in Section 18 of
this QAP.

15.4 Supplier Nonconformances

Supplier nonconformances enter the AREVA NP Inc. system in one of three ways:

• By the submittal of a written request by a supplier for approval of


nonconformances that violate requirements of AREVA NP Inc. procurement
documents or AREVA NP Inc. approved supplier drawings, specifications, or
procedures and the supplier wishes to repair the nonconforming item or use-as-
is. This request takes the form of a Contract Variation Approval Request (CVAR)
as described in Section 15.5 of this QAP
• By audit findings initiated by QA to identify nonconformances found during
supplier audits as described in Section 18 of this QAP
• By Condition Reports issued by quality representatives to document
nonconformances detected during source inspection or surveillance as described
in Section 7 of this QAP

15.5 Contract Variation Approval Request (CVAR)

CVAR’s may result from supplier nonconformances as discussed in Section 15.4 of this
QAP. The CVAR (or equivalent supplier document) is prepared by the supplier and
includes the determination of cause, corrective action, and recommended disposition,
i.e., repair or use-as-is. Repair dispositions must be accompanied with a repair
procedure or indicate the repair will be performed in accordance with an AREVA NP Inc.
approved repair procedure. The supplier transmits the CVAR to AREVA NP Inc. for
evaluation by the responsible technical manager.

CVAR’s which affect interface, function, or interchangeability are evaluated by the


responsible engineer. CVAR’s which affect these parameters are also evaluated by the
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 15-4

project management function for possible notification to the customer or submittal for
acceptance as prescribed in the customer’s contract.

AREVA NP Inc.’s disposition of a CVAR may be either approved or disapproved.


Approval of use-as-is dispositions must be justified by the responsible technical
manager either by attaching to or referencing on the CVAR such justification.
Disapproved CVAR’s may indicate the reasons for disapproval or alternate dispositions.

Upon receipt of the dispositioned CVAR, the supplier will initiate appropriate actions
consistent with the AREVA NP Inc. disposition.

The dispositioned CVAR is entered into the Records Management System and returned
to the supplier.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 16-1

16.0 CORRECTIVE ACTION

Section 16.0, Corrective Action is applicable to the design certification project.

This section complies with Criterion XVI of 10 CFR 50, Appendix B, Corrective Action,
and Basic Requirement 16, Corrective Action, of ANSI/ASME NQA-1-1994.

16.1 Purpose

This section defines the elements of the corrective action generation, implementation
and verification system for safety related items or services.

16.2 General

Procedures are established by AREVA NP Inc. to ensure prompt identification and


correction of conditions adverse to quality, such as failures, malfunctions, deficiencies,
deviations, defective material and equipment, and nonconformances during the design,
procurement, fabrication, inspection, and testing of items. These procedures require
the cognizant function assure that:

• All personnel have the responsibility of reporting and/or recording known or


identified conditions adverse to quality.
• Nonconformances and failures are evaluated to determine the need for corrective
action, and that such action is taken as necessary.
• The cause of the nonconformance or failure is determined and action is taken to
preclude recurrence.
• Appropriate levels of management are informed of significant conditions adverse
to quality, the cause of the conditions, the corrective action taken, and the
preventive action taken to preclude recurrence.

Follow-up is conducted to verify proper implementation of both corrective and


preventive actions and to close out the corrective action documentation.

Responsibilities within the Corrective Action program are not delegated. AREVA NP
Inc. maintains responsibility for the program’s effectiveness.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 16-2
16.3 Implementation

Condition Reports are generated/received by AREVA NP Inc. as described in Section


15 of this QAP. They are analyzed by QA to determine whether more extensive actions
are required in addition to any corrective action applied to the specific nonconformance.
The stated cause of the nonconformance is reviewed by QA to determine the following:

• Whether there have been previous occurrences,


• Whether the root cause may result in subsequent nonconformances if not
corrected,
• Whether the cause indicates a defect or a correctable trend in design, fabrication,
processing, personnel training, etc.
• Potential problems identified by QA’s review are reported to the responsible
organization for further corrective action. Subsequent review and follow-up is
accomplished by QA to determine the effectiveness of the corrective action
taken.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 17-1

17.0 QUALITY ASSURANCE RECORDS

Section 17.0, Quality Assurance Records, applies to the Design Certification Project.

This section complies with Criterion XVII of 10 CFR 50, Appendix B, Quality Assurance
Records, and Basic Requirement 17, Quality Assurance Records and the following
supplemental requirements of ANSI/ASME NQA-1-1994:

• 17S-1, Supplementary Requirements for Quality Assurance Records

The AREVA NP Inc. Records Management System also implements the requirements
of the following:

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


Technical Guide (TG) 11-1998, “Authentication of Records and Media”
• NIRMA TG 15-1998, “Management of Electronic Records”
• NIRMA TG 16-1998, “Software Configuration Management and Quality
Assurance”
• NIRMA TG 21-1998, “Electronic Records Protection and Restoration”
• Regulatory Issues Summary (RIS) 2000-18, “Guidance on Managing QA
Records in Electronic Media.”
17.1 Purpose

This section defines the requirements for the collection, retention and retrievability of
QA records for safety related items or services.

17.2 General

AREVA NP Inc. procedures are established to provide requirements and responsibilities


for document access, user privileges, records generation, identification, transmittal,
retention, and maintenance including design documentation and records not only for the
final design documents, such as drawings and specifications, and revisions thereto, but
also documentation which identifies the important steps, including sources of design
input that support the final design.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 17-2

Scheduled inspections, surveillances or audits of the program software applications and


media are performed that ensure electronic records retrievability, integrity and retention
periods and meet the guidance provided in Regulatory Issue Summary 2000-18.

QA records are filed and maintained for the durations defined in the Corporate Records
Management Manual 1E1.

The AREVA NP Inc. records management program does not meet the requirements of
NRC Generic Letter 88-18 for the storage of electronic media on optical discs. The
AREVA NP Inc. records management program is written and implemented to satisfy the
guidance provided in RIS 2000-18 and NIRMA Technical Guidelines TG-11, TG-15, TG-
16 and TG-21.

This records program meets or exceeds the requirements of ANSI N45.2.9 (Reg. Guide
1.88). QA records include the following documents:

• Procurement Documents
• Procedures and Instructions
• Drawings
• Specifications
• Design Analysis Calculations and Review
• Contract Agreements
• Audit Records (internal and external)
• Personnel Qualifications
• Inspection and Test Records
• Nonconformance Records
• Corrective Action Records
• Receiving Inspection Records
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 17-3
17.3 Implementation

Records Management maintains and controls QA records generated by AREVA NP Inc.


and/or submitted by suppliers/customers. Records Management procedures provide
record identification and control, and address protection and retrieval of records to
prevent deterioration, damage, or loss.

Documents being entered into the records management system are examined for
adequacy, legibility and completeness.

Entities not located near the home office will submit QA records to Records
Management on a frequency determined in appropriate procedures.

At the completion of a contract, the QA records for the contract will be stored by AREVA
NP Inc. and/or provided to the customer as specified in the contractual agreements.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 18-1

18.0 AUDITS

Section 18, Audits, applies to the design certification project.

This section complies with Criterion XVIII of 10 CFR 50, Appendix B, Audits, and Basic
Requirement 18, Audits, and the following supplemental requirements of ANSI/ASME
NQA-1-1994:

• 18S-1, Supplementary Requirements for Audits

In addition, Personnel who perform audits are qualified to the requirements of NQA-1-
1994, Supplement 2S-3, and ANSI N45.2.23.

18.1 Purpose

This section describes the elements of quality auditing.

18.2 General

The AREVA NP Inc. audits program is defined by written procedures providing program
definition as well as direction and guidance for audits and the supporting activities
concerned. These procedures establish the scheduling, preparation, execution,
reporting, and follow-up methods to be used in implementing the audits program. The
audits conducted under the QA audits program include:

• An objective evaluation of quality related practices, procedures, and instructions


• The effectiveness of implementation
• Conformance with policies and procedures
• Indoctrination and training programs
• Interfaces within AREVA NP Inc. and with the customer
• Corrective action, calibration, and nonconformance control systems
• Design Control, calculations and associated computer codes
• Review of documents and records

Audits are regularly scheduled based upon the status and safety related importance of
the activities being performed and are initiated early enough to assure effective QA
during design, procurement, fabrication, inspection, and testing. Audits are performed
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 18-2

in accordance with pre-established written procedures or checklists and conducted by


personnel having no direct responsibilities in the areas being audited. Personnel who
perform audits are qualified to the requirements of ASME NQA-1-1994, Supplement 2S-
3, and ANSI N45.2.23. Certification files are maintained in the AREVA NP Inc. QA
Department and Records Management.

Audit plans are developed and documented for each audit. The Audit Plan identifies the
scope of the audit, applicable requirements and audit personnel, activities to be audited,
organizations to be notified, applicable documents, schedule, and written procedures
and checklists.

Responsibilities within the audit program are not delegated; AREVA NP Inc. maintains
responsibility for the audit program effectiveness.

18.3 Internal Audits

Internal audits of AREVA NP Inc. activities are used to evaluate compliance with, and
the effectiveness of, the QAP. These audits are scheduled to cover the quality program
elements once each calendar.

Audit results of AREVA NP Inc. activities are provided to the managers of the
organizations audited, the President and CEO of AREVA NP Inc., and the Vice
President, Quality & Performance for review, analysis, and direction. Managers of the
audited organizations investigate audit findings, determine cause, schedule corrective
action, including measures to prevent recurrence, and provide written responses to the
findings of the audit. Follow-up is conducted by QA to ensure implementation of
appropriate corrective and preventive actions. When necessary, follow-up will include
an audit of deficient areas.

18.4 Supplier Audits

Suppliers of safety-related items and services are evaluated to assure that only qualified
suppliers are used. An audit is performed when sufficient work is in progress to
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 18-3

demonstrate that the supplier is implementing a QA program. Qualified suppliers are


audited on a triennial basis. In addition, if a subsequent contract or a contract
modification significantly enlarges the scope of or changes the methods or controls for
activities performed by the same supplier, an audit of the modified requirements is
conducted, thus starting a new triennial period. AREVA NP Inc. may utilize audits
conducted by outside organizations for supplier qualification provided that the scope
and adequacy of the audits meet AREVA NP Inc. requirements. Documented annual
evaluations are performed for qualified suppliers to assure they continue to provide
acceptable products and services. Industry programs, such as those applied by ASME,
Nuclear Industry Assessment Committee (NIAC), or other established utility groups, are
used as input or the basis for supplier qualification whenever appropriate. The results
of the reviews are promptly considered for effect on a supplier’s continued qualification
and adjustments made as necessary (including corrective actions, adjustments of
supplier audit plans, and input to third party auditing entities, as warranted). In addition,
results are reviewed periodically to determine if, as a whole, they constitute a significant
condition adverse to quality requiring additional action.

Evaluations of suppliers are documented and take into account the following, where
applicable:

• Receipt inspection, operating experience, and supplier evaluation programs are


reviewed on an ongoing basis as the information becomes available. The results
of the review are promptly considered for effect on a suppliers continued
qualification and adjustments made as necessary (including corrective actions,
adjustments of suppliers audit plans and input to third party auditing entities as
warranted). Additionally, results are reviewed periodically to determine if, as a
whole, they constitute a significant condition adverse to quality requiring
additional action.
• If there is no ongoing receipt inspection or operating experience with which to
analyze the supplier for a period of twelve (12) months, an annual evaluation
shall be performed as follows:
- Review of supplier-furnished documents and records such as certificates of
conformance, nonconformance notices, and corrective actions
- Results of previous source verifications, audits and receiving inspections
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page 18-4
- Operating experience of identical or similar products furnished by the same
supplier
- Results of audits from other sources (e.g., customers, ASME, NIAC (Nuclear
Industries Assessment Committee) or NRC audits)
18.5 Audit Reports

The audit report is signed by the audit team leader and issued. The report includes the
following information as appropriate:

• Description of audit scope


• Identification of auditors
• Identification of persons contacted during the audit activity
• Summary of audit results including a statement on the effectiveness of the QA
program elements which were audited
• Description of each reported adverse audit finding in sufficient detail to enable
corrective action to be taken by the audited organization
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page A-1

APPENDIX A

QA Program Implementing Policies, Procedures, and Instructions

Document Applicable QA
Number Document Title Document Section
Policy 0401 Evaluation and Reporting Per 10 CFR 21 4, 7, 15
Policy 0402 Quality Assurance Program 1,2
Policy 0501 Approval, Control, and Management of 5, 6
Corporate Policies and Implementing,
Procedures

0303-09 Project Work Authorization 2, 3


0310-03 Authorization of Contract Work 2, 3
0310-05 Product Numbering 8
0310-38 Historical Documents List (HDL) 6, 17
0313-01 Nuclear parts Center Contract Administration 4, 6, 7
0402-01 Calculations 3, 6
0402-02 Peer Reviews 3, 6
0403-11 Technical Document Signatures 3, 6
0405-03 Plant Technical Requirements Document 3, 6
0405-05 Contract Variation Approval Requests 15, 16
0405-11 General Design Text Documents 3, 6
0405-12 General Design Drawings 3, 5, 6
0405-13 Project Design Guideline and Directives 2, 3
0405-14 Developing and Implementing a Reliability 2, 3
Assurance Program for U.S. EPR Projects
0405-22 Design Review Boards 3
0405-30 Design Verification Testing 3-6, 11
0405-37 Maintenance of ASME Code Certification 3
Requirements for Professional Engineers
0411-08 Revising and Processing Product 3, 6
Documentation Prepared by Suppliers
0412-55 Developing and Revising Specifications 3-6, 11, 13
0412-59 Engineering Technical Documents 3, 5, 6, 11
0412-63 Technical Document Format 3, 5, 6
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page A-2
Document Applicable QA
Number Document Title Document Section
0412-66 Release of Product Documentation 3-6
0412-67 Processing Technical Documents from 3-7
Suppliers and Customers
0412-76 Dedication (10 CFR Part 21) 4, 7, 15
0413-05 Acting as an Owners Agent for Review of 3, 6
Design (Stress) Reports and Addendum (ASME
Code Components)
0414-12 Preparation and Processing of Licensing 3, 6
Documents
0418-01 Preparation, Control, and Revisions to Final 3, 6
Safety Analysis Report - FSAR
0418-02 Managing Interface with the Nuclear Regulatory 3
Commission
0504-15 Preparing and Processing Operating Guidelines 3, 6
0504-16 Nuclear Products Advisory Bulletins (NPAB) 16
0509-11 Measuring and Test Equipment Calibration 12
0902-12 Certification File Access Control System for 3
Computers Using a UNIX-Based Operating
System
0902-13 Production System Software and Hardware 3
changes
0902-19 Engineering Software Error Reporting and 3
Evaluation
0902-28 Development of Engineering Applications 3
Software
0902-29 Procurement of Engineering Applications 3, 4, 7
Software
0902-30 Management and Use of Engineering 3, 6
Applications Software
0903-03 Development and Control of Software 3, 6
Documentation
1212-12 Purchasing Documents 4
1303-07 Control of Corporate Policies and Implementing 5, 6
Documents
1303-17 Operating Instructions 5, 6
1702-22 Employee Training 2
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page A-3
Document Applicable QA
Number Document Title Document Section
1702-25 Assignment of Nuclear Safety Classification to 2
Products and Services
1703-01 Restraint Order 15, 16
1705-03 Quality Assurance Data Packages and 7
Certificates of Conformance
1705-16 QA Review of Procurement Packages 4
(Purchasing Requisition) and Customer Order
Entry Document (COED) Packages
1707-01 Evaluation and Reporting per 10 CFR 21 15, 16
1708-08 Quality Control Surveillance 7
1710-01 Appointment of Level III NDE Examiner 9
1710-02 Appointment of Level III Quality Control 7, 10
Inspection and Surveillance (QCI&S) Examiner
1710-03 Process management 5
1717-06 Corrective Action Program (WebCAP) 15, 16
1719-21 Quality Assurance Audits of Internal Activities 18
1719-22 Quality Assurance Audits of Suppliers 7, 18
1719-23 Qualification of Quality Assurance Audit 2, 18
Personnel
1719-32 Self-Assessment 15, 16
1720-01 Review and Dissemination of Regulatory 3
Actions and Industry Events
1720-02 10 CFR 50.46 Reporting Requirements 3
1721-01 Quality Engineering (QE) Surveillance of 2, 3
Engineering Activities
1724-01 Supplier Quality Oversight 4, 7
1729-01 Quality, Safety and Environmental Management 15, 16
System Management Reviews
1902-12 Proprietary Classification of Technical 3
Documents and Sensitive Information
1902-14 Control of Safeguards Information 3
56-9141754 AREVA Inc. Quality Assurance Program All
56-1151178 AREVA NP Inc. ASME Section III and XI All
Quality Assurance Manual
1E1 Records Management Program Manual 17
105-5017274 Projects Manual 2, 3
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page A-4
Document Applicable QA
Number Document Title Document Section
EG-01 Plants U.S. Training Program 1, 2
EG-02 Customer Feedback Survey Process 16
EG-03 Customer Feedback Evaluation Process 16
EG-04 External Communications 2
EG-05 Tracking Customer Deliverables 2
EG-06 Engineering Task Plans 2
EG-07 Engineering Qualification Process 2
EPR-EN-PR-1002 Design Control Process 3, 5
EPR-EN-PR-1003 Design Change Control Process 3, 5
EPR-EN-PR-1004 Development of System Design Requirements 3, 5
Documents
EPR-EN-PR-1005 Establishing Structures, Systems and 3, 5
Components Safety Classifications
EPR-EN-PR-1006 Development of System Description Documents 3, 5
EPR-EN-PR-1007 Design Interface Control 3, 5
EPR-EN-PR-1009 Development of Analytical Input Requirements 3, 5
Specifications (AIRS)
EPR-EN-PR-1011 Structure, System and Component Design 3, 5
Bases
EPR-EN-PR-1012 Development of I&C Requirements 3, 5
EPR-EN-PR-1013 Interdisciplinary Coordination and Review 3, 5
Process
EPR-EN-PR-1016 Requirements for the Electrical Load Lists 3, 5
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page B-1

APPENDIX B

Regulatory Commitments: Compliance with Applicable Regulatory Guides,

Generic Letters, and Standards

I. AREVA NP Inc.’s position with respect to the NRC Regulatory Guides pertaining
to Quality Assurance as they apply to the AREVA NP Inc. scope of supply is as
follows:
a. Regulatory Guide 1.26, Quality Guide Classifications and Standards for
Water, Steam, and Radioactive Waste Containing Components of Nuclear
Power Plants, Revision 4 – AREVA NP Inc. complies with the provisions of
this Guide. AREVA NP Inc. generally classifies nuclear core components as
safety related.
b. Regulatory Guide 1.28, Quality Assurance Program Requirements (Design &
Construction, Revision 2 – this Guide endorses ANSI N45.2-1977, “Quality
Assurance Program Requirements for Nuclear Power Plants,” as an
appropriate basis for compliance with Appendix B of 10 CFR 50, Appendix B.
AREVA NP Inc. complies with the provisions of this Guide.
c. Regulatory Guide 1.28, Quality Assurance Program Requirements (Design &
Construction), Revision 3 – this Guide endorses ANSI/ASME NQA-1 as an
appropriate basis for compliance with 10 CFR 50, Appendix B. AREVA NP
Inc. complies with the provisions of this Guide with the following clarifications:
i. Regulatory Guide 1.28, Section C.1: Qualification of Inspection and
Test Personnel – AREVA NP Inc. follows the regulatory position
provided in Regulatory Guide 1.28, Section C.1 with the clarifications
supplied for Regulatory Guide 1.58 in this Appendix.
ii. Regulatory Guide 1.28, Section C. 2: Quality Assurance Records –
AREVA NP Inc. follows the regulatory position provided in Regulatory
Guide 1.28, Section C.2 with the clarification supplied for Regulatory
Guide 1.88 in this Appendix.
iii. Regulatory Guide 1.28, Section C.3: Audits – AREVA NP Inc. follows
the regulatory position provided in Regulatory Guide 1.28, Section C.3
with the clarifications supplied in Regulatory Guide 1.144 in this
Appendix.
iv. ANSI/ASME NQA-1, Section 4.0, Design Verification – the
clarifications noted for Regulatory Guide 1.64 in this Appendix,
regarding the use of managers or supervisors as independent
reviewers, applies.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page B-2
d. Regulatory Guide 1.29, Seismic Design Classification, Revision 4 – AREVA
NP Inc. complies with the provisions of this Guide.
e. Regulatory Guide 1.30, Quality Assurance Requirements for Installation,
Inspection, and Testing of Instrumentation and Electrical Equipment, Revision
0 – this Guide endorses ANSI N.45.2.4 – 1972 (IEEE Standard 336 – 1971),
“Installation, Inspection, and Testing Requirements of Instrumentation and
Electrical Equipment During the Construction of Nuclear Power Generating
Stations,” as an adequate basis for compliance with 10 CFR 50, Appendix B.
This standard applies to on-site installation, inspection, and testing of safety
related instrumentation and electrical equipment. This function is normally
the responsibility of the plant owner, and this standard is reflected in the
owner’s procedures applicable to the work. AREVA NP Inc. provides
appropriate drawings, instructions, and consultation to aid the owner in
compliance with this Guide.
f. Regulatory Guide 1.37, Quality Assurance Requirements for Cleaning of Fluid
Systems and Associated Components of Water-Cooled Nuclear Power
Plants, Revision 1. AREVA NP Inc. complies with the provisions of this Guide.
g. Regulatory Guide 1.58*, Qualification of Nuclear Power Plant Inspection,
Examination, and Testing Personnel, Revision 1 – this Guide endorses ANSI
N45.2.6 – 1978, “Qualifications of Inspection, Examination, and Testing
Personnel for the Construction Phase of Nuclear Power Plants,” for use in
compliance with 10 CFR 50, Appendix B. Although ANSI N.45.2.6 – 1978 is
applicable only to the construction phase of a nuclear power plant, this
Regulatory Guide states that the provisions of ANSI N45.2.6 – 1978 are
“generally applicable… during fabrication prior to receipt of items at the
construction site.” AREVA NP Inc. satisfies this Guide through ensuring that
off-site inspection, examination, or testing is performed and/or monitored by
AREVA NP Inc. QA representatives qualified to meet the applicable
requirements of ANSI N45.2.6. AREVA NP Inc. ensures that nondestructive
examinations are performed by personnel certified to SNT-TC-1A in
compliance with Section 2 of this Guide, and those other inspections,
examinations, or testing is performed by personnel qualified in accordance
with applicable requirements.
h. Regulatory Guide 1.64*, Quality Assurance Requirements for the Design of
Nuclear Power Plants, Revision 2 – this Guide endorses ANSI N45.2.11 –
1974, “Quality Assurance Requirements for the Design of Nuclear Power
Plants,” as acceptable for compliance with 10 CFR 50, Appendix B with noted
amplifications.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page B-3
The following AREVA NP Inc. clarification is identified with respect to Section
C.2 of this Guide regarding the use of managers or supervisors as
independent reviewers:
All design documents are independently reviewed for completeness and
technical accuracy. The reviewer may be:
(1) Any competent individual other than the preparer of the document as
determined by the cognizant manager.
(2) The preparer’s immediate supervisor provided the supervisor did not
prescribe or limit the techniques or inputs used in the design document.
The use of supervisors as reviewers is approved in each instance by the
cognizant manager.
(3) The preparer’s manager provided the manager is the only technically
qualified individual available. In this case, the need is documented and
approved by the next higher level of management on each occasion.
i. Regulatory Guide 1.74*, Quality Assurance Terms and Definitions, Revision 0
– this Guide endorses ANSI N45.2.10 – 1973, “Quality Assurance Terms and
Definitions,” for use in describing and implementing quality assurance
programs. AREVA NP Inc. uses the appropriate definitions of ANSI N45.2.10
– 1973 and supplements these terms with others considered necessary to
provide a common interpretation of the AREVA NP Inc. QAP. These
provisions satisfy this Regulatory Guide.
j. Regulatory Guide 1.88*, Collection, Storage, and Maintenance of Nuclear
Power Plant Quality Assurance Records, Revision 2 – this Guide endorses
ANSI N45.2.9 – 1974, “Requirements for Collection, Storage, and
Maintenance of Quality Assurance Records for Nuclear Power Plants,” for
use in compliance with criterion XVII of 10 CFR 50, Appendix B. The AREVA
NP Inc. Records Management Manual complies with this Regulatory Guide,
effective June 16, 1975.
k. Regulatory Guide 1.123*, Quality Assurance Requirements for Control of
Procurement of Items and Services for Nuclear Power Plants, Revision 1 -
this Guide endorses ANSI N45.2.13 – 1976, “Quality Assurance
Requirements for Control of Procurement of Items and Services for Nuclear
Power Plants.” AREVA NP Inc. complies with the provisions of this Guide.
l. Regulatory Guide 1.144*, Auditing of Quality Assurance Programs for Nuclear
Power Plants, Revision 1 – this Guide endorses ANSI N45.2.12-1977,
“Requirements for Auditing of Quality Assurance Programs for Nuclear Power
Plants.” The standard establishes requirements for conducting audits of
quality assurance programs both internally and externally (suppliers). AREVA
NP Inc. satisfies the requirement for internal audits by auditing each
applicable element of its Quality Assurance Program at least once during a
calendar year. External (Supplier) audits are regularly scheduled on the basis
of supplier performance and importance to safety of the activities being
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page B-4
performed. Audit frequency of suppliers, normally between one and three
years, may be altered (increased or decreased) based on an annual
evaluation of the supplier’s quality assurance program, history of
performance, and implementation of that program. This evaluation considers
the complexity of the system or component concerned and the degree of
quality and process control required by the manufacturing effort.
m. Regulatory Guide 1.146*, Qualification of Quality Assurance Program Audit
Personnel for Nuclear Power Plants, Revision 0 – this Guide endorses ANSI
N45.2.23 – 1978, “Qualification of Quality Assurance Program Audit
Personnel for Nuclear Power Plants.” AREVA NP Inc. complies with the
provisions of this Guide.
n. Generic Letter 89-02, “Actions to improve the dedication of counterfeit and
fraudulent marketed products.” AREVA NP Inc. conforms to the provisions of
this generic letter.
o. Generic Letter 91-05, “Licensee Commercial Grade Dedication Programs.”
AREVA NP Inc. conforms to the provisions of this generic letter.
p. ANSI/ASME NQA-1-1994 Edition, Subpart 2.7, “Quality Assurance
Requirements of Computer Software for Nuclear Facility Application.”
AREVA NP Inc. conforms to the provisions of this subpart.
q. Regulatory Issues Summary 2000-18, “Guidance on Managing Quality
Assurance Records in Electronic Media.” AREVA NP Inc. conforms to the
provisions of this guidance.
r. Nuclear Information and Management Association Inc. (NIRMA) Technical
Guide (TG) 11-1998, “Authentication of Records and Media.” AREVA NP Inc.
conforms to the provisions of this guide.
s. NIRMA TG-15-1998, “Management of Electronic Records.” AREVA NP Inc.
conforms to the provisions of this guide.
t. NIRMA TG-16-1998, “Software Configuration Management and Quality
Assurance.” AREVA NP Inc. conforms to the provisions of this guide.
u. NIRMA TG-21-1998, “Electronic Records Protection and Restoration.”
AREVA NP Inc. conforms to the provisions of this guide.
II. AREVA NP Inc.’s review and analysis of the following QA related regulatory
guides indicate that they are applicable to the AREVA NP Inc. scope of supply if
invoked by a customer.
a. Regulatory Guide 1.39, Housekeeping Requirements for Water-Cooled
Nuclear Power Plants, Revision 0 – this guide endorses ANSI N45.2.3-1973,
“Housekeeping During Construction Phase of Nuclear Power Plants.”
III. AREVA NP Inc.’s review and analysis of the following QA related regulatory
guides indicate that they are not applicable to the AREVA NP Inc. scope of
supply.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page B-5
a. Regulatory Guide 1.94, Quality Assurance Requirements for Installation,
Inspection, and Testing of Structural Steel During the Construction Phase of
Nuclear Power Plants, Revision 1
NOTE: The asterisk (*) indicates regulatory guides which were withdrawn by the
NRC. They are included in this Document because selected utilities were
licensed to these requirements.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page C-1

APPENDIX C

Definitions

Acceptance Criteria

Specified limits placed on characteristics of an item, process, or service defined in


codes, standards, or other requirements documents and used to determine whether an
item, process, or service is satisfactory.

Annual

Defined as occurring within a calendar year, performance of duties shall not be less
than 10 months or more than 14 months. Individual procedures may be more
restrictive.

Approval

The act of endorsing or assigning positive authorization, or both.

As-Built Data

Documented data that describes the condition actually in an item.

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. An audit should not be confused with surveillance
or inspection activities performed for the sole purpose of process control or product
acceptance.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page C-2
Certificate of Conformance (CoC)

A document signed or otherwise authenticated by an authorized individual certifying the


degree to which items or services comply with specified requirements.

Characteristic

Any property or attribute of an item, process, or service that is distinct, describable, and
measurable.

Cleanliness

A state of being clean in accordance with predetermined standards, and usually implies
freedom from dirt, dust, rust, oil, or other contaminating impurities.

Critical Characteristic

Those characteristics that are essential for performance of an item’s safety related
function(s). Typical critical characteristics are attributes such as form, fit, dimensions,
material including physical, mechanical, and chemical properties, electrical, thermal, or
other functional parameters.

Commercial Grade Item

When applied to nuclear power plants licensed pursuant to 10 CFR 50, commercial
grade item means a structure, system or component, or part thereof that affects its
safety function, that was not designed and manufactured as a basic component.
Commercial grade items do not include items where the design and manufacturing
process require in-process inspections and verifications to ensure that defects or
failures to comply are identified and corrected, i.e., one or more critical characteristics of
the item cannot be verified.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page C-3
Computer Program (Code Software)

A sequence of instructions suitable for processing by a computer. Processing may


include the use of an assembler, a compiler, and interpreter, or a translator to prepare
the program for execution as well as to execute it.

Condition Adverse to Quality

An all inclusive term used in reference to any of the following: failures, malfunctions,
deficiencies, defective items, and nonconformances. A significant condition adverse to
quality is one which, if uncorrected, could have a serious effect on safety and
operability.

Corrective Action

Measures taken to rectify conditions adverse to quality and, where necessary, to


preclude repetition.

Defective Material and Equipment

A material or component which has one or more characteristics that do not comply with
specified requirements.

Deficiency

The quality or condition of being deficient; incompleteness or inadequacy.

Deviation

A nonconformance or departure of a characteristic from specified requirements.

Document

Any written or pictorial information describing, defining, specifying, reporting, or


certifying activities, requirements, procedures, or results.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page C-4
Document Master Lists

Lists of documents to which an individual may refer to determine the current revisions of
documents applicable to an activity, project, or contract. Includes such lists as:
applicable documents list, contract documents list, historical documents list, procedure
document table of contents or plan list, etc.

Documentation

A compilation of those documents concerning a specific function, activity or project.

Examination

An element of inspection consisting of investigation of materials, components, supplies,


or services to determine conformance to those specified requirements which can be
determined by such investigations. Examination is usually nondestructive and includes
visual, simple physical manipulation, gauging, measurement and written documentation.

Failures

A failing (or number of failings) to perform a duty or expected action.

Handling

An act of physically moving and/or lifting items by hand or mechanical means.

Hold

An action by a quality organization wherein an item is withheld and segregated from


further processing until a disposition has been defined and imposed.

Hold Point

A point at which witnessing of examinations is required by the quality organization or


customer and beyond which point work shall not proceed without consent of the quality
organization or customer representative respectively.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page C-5
Inspection

Examination or measurement to verify whether an item or activity conforms to specified


requirements.

Inspection and Test Records

Documents that furnish evidence of the completion of inspection and tests. They
contain the following, where applicable: a description of type of observation, the date
and results of the inspection or tests, inspector or data recorder identification, evidence
of acceptability of the item inspected or tested, and action taken to resolve any
nonconformances noted.

Inspector

A qualified individual whose duties include verification of quality related activities and
who is independent of the activity being verified.

Item

An all-inclusive term used in place of any of the following: appurtenance, assembly,


component, equipment, material, module, part, structure, sub-assembly, sub-system,
system, or unit.

Malfunctions

To function imperfectly or badly, fails to operate in the normal or usual manner.

Measuring & Test Equipment

Devices or systems used to calibrate, measure, gauge, test, or inspect in order to


control or to acquire data to verify conformance to specified requirements.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page C-6
Nonconformance

A deficiency in characteristic, documentation, performance, or procedure which renders


the quality of an item unacceptable or indeterminate.

Non-Destructive Examination

A method of detecting indications of discrepancies without destroying the usefulness of


the item or material.

Non-Safety Related

Any item or service that has quality requirements greater than commercial, but less than
safety related as defined by specific customer procurements.

Objective Evidence

Any statement of fact, information, or record, either quantitative or qualitative pertaining


to the quality of an item or service which can be verified by records of tests,
examinations, inspections, measurements, or observations.

Out of Commission

An item of equipment that is not able to perform its intended function.

Procedure

A document which specifies instructions for performance of a particular task. It includes


methods to be employed, description of equipment or material to be used, sequence of
operations, etc.

Process

One or more operations, methods, functions, procedures, or other specified actions


which result in the desired item or result.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page C-7
Purchasing Authorization

A document used to transmit procurement information/documents to purchasing for the


purpose of obtaining bids, placing orders and change orders.

Purchasing Document

A contractually binding document identifying and defining the requirements which items
or services must meet prior to acceptance. Also includes purchasing authorizations,
purchase requisitions, purchase orders, contracts, drawings, specifications, or
instructions.

Purchase Requisition

Electronic generated requests used to transmit procurement information/documents to


purchasing for the purpose of obtaining bids, placing orders and change orders.

Project Management Function

An individual responsible for technical contract, quality, budget, schedule or delivery of


a product or service.

Qualification (Personnel)

The characteristics or abilities of an individual, gained through training and/or


experience that enables him to perform specific functions.

Qualified Equipment

Equipment which has been evaluated by sufficient testing to assure performance within
specified parameters.

Qualified Party or Individual

A person or organization competent and recognized as knowledgeable to perform


certain functions.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page C-8
Qualified Procedure

A procedure which incorporates all applicable code and standard requirements,


manufacturing parameters, and specifications, which has been proven adequate for the
intended purpose.

Quality

The properties or characteristics constituting those prerequisites or specifications,


codes, standards, industrial practices, other recognized methods and/or acceptance
criteria by which an item is judged.

Quality Assurance

All those planned and systematic actions, including quality administration and quality
control, which provide adequate confidence that an item will perform satisfactorily in
service.

Quality Assurance Plan

The application of a contract which implies a departure from the general requirements of
the QA Program may be addressed in a Quality Assurance Plan. It may also reflect
additions that a customer invokes in a contract.

Quality Assurance Record

A completed document that furnishes evidence of the quality of items and/or activities
affecting quality. Records must be validated by stamps, initials, or signatures of
authorized personnel or otherwise authenticated.

Quality Control

Those quality assurance actions which provide a means to control and measure the
characteristics of an item or process to established requirements.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page C-9
Reject

A disposition which may be imposed on a nonconforming item providing for its


withdrawal and isolation from further processing pending an evaluation as to repair,
rework, use-as-is, or scrap.

Repair

The process of restoring a nonconforming characteristic to a condition such that the


capability of an item to function reliably and safely is unimpaired, even though the item
still may not conform to the original requirements in every aspect.

Review/Approval

Acceptance indicated by signature/initials and date.

Rework

The process by which a nonconforming characteristic to a condition such that he


capability of an item to function reliably and safely is unimpaired, even though the item
still may not conform to the original requirements in every aspect.

Safety Related

Safety related items are the equipment that is relied upon to remain functional during
and following design basis events to ensure:

• The integrity of the reactor coolant pressure boundary.


• The capability to shut down the reactor and maintain it in a safe shutdown; or
• The capability to prevent or mitigate the consequences of accidents that could
result in potential offsite exposure comparable to the guidelines in 10 CFR
50.34(a)(1), 50.67(b)(2), or 100.11 of this chapter, as applicable.

Scrap

A disposition which may be imposed upon a nonconforming item when it has been
established that the discrepancy renders the item unfit for its intended use and it is not
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page C-10
economically or otherwise feasible to repair or rework it. Scrap may also be excess
material or damaged material remaining from fabrication operations which is unsuitable
for further use.

Service

The performance of activities such as engineering, inspection, test, nondestructive


examination, destructive examination, qualification of personnel, procedures and
equipment, audits, and calibration of measuring and test equipment.

Source Inspection or Surveillance

A review, observation or inspection for the purpose of verifying that an action has been
accomplished as specified at the location of item procurement or manufacture.

Special Process

A process, the results of which are highly dependent on the control of the process or the
skill of the operators, or both, and in which the specified quality cannot be readily
determined by inspection or test of the product.

Specification

A concise statement of a set of requirements to be satisfied by a product, material, or


process indicating, whenever appropriate, the means by which it may be determined
whether the requirements given are satisfied.

Substantial Safety Hazard

A loss of safety function to the extent that there is a major reduction in the degree of
protection provided to public health and safety for any licensed facility.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page C-11
Supplier

Any individual or organization who furnishes items or services in accordance with a


procurement document. An all inclusive term used in place of any of the following:
vendor, seller, contractor, sub-contractor, fabricator, consultant, and their sub-tier levels.

Surveillance

The act of monitoring or observing to verify whether an item or activity conforms to


specified requirements.

Testing

An element of verification for the determination of the capability of an item to meet


specified requirements by subjecting the item to physical, chemical, environmental, or
operating conditions.

Traceability

The ability to trace the history, application, or location of an item and like items or
activities by means of recorded identification.

Use-As-Is

A disposition permitted for a nonconforming item when it can be established that the
item is satisfactory for its intended use.

Verification

The act of reviewing, inspecting, testing, checking, auditing, or otherwise determining


and documenting whether items, processes, services, or documents conform to
specified requirements.

Waiver

Documented authorization to depart from some specified requirements.


AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report Page C-12
Witness

To observe a performance.

Witness Point

A step in a process for which the quality organization or customer has requested
notification. An organization may proceed past a witness point if the quality
organization or customer representative is not present at the appointed time.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report AP-1

ADDENDUM A

Non-Safety Related Products and Services

A-0 INTRODUCTION

This Document Addendum describes the Quality Assurance Plan (QAP) for the non-
safety related products and services supplied by AREVA NP Inc. This excludes safety
related products and services as listed in Section 1 – 18 of this document and ASME
Boiler & Pressure Vessel Code items and activities which are covered by separate QAP
documents.

A-1 ORGANIZATION

Same as Document Section 1.

A-2 QUALITY ASSURANCE PROGRAM

A-2.1 Scope

This QAP for non-safety related products and services takes into account the
prerequisites for achieving quality, such as the need for specialized equipment and
skills, use of administrative, process, and environmental controls, training and
indoctrination of personnel performing activities affecting quality, and the need for
verification of quality by inspection and test.

The classification of items and services as non-safety related is made and documented
by the responsible technical manager and project management functions. The criteria
for determining this classification is contained in an implementing procedure.
Essentially, any item or service that has quality requirements greater than commercial,
but less than safety related as defined by specific customer procurements both internal
and external is considered to be non-safety related (refer to Appendix C for definitions).
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report AP-2
A-2.2 QAP Requirements

This QAP for non-safety related products and services is organized and administered to
comply with the Quality Policy in the front of this document. It also allows for quality
requirements as may be imposed by contract. This QAP establishes minimum
requirements for non-safety related products and services.

At the discretion of the project management function, their products and services may
be processed as safety related per Sections 1 – 18 of this document.

A-2.3 QAP Implementation

The policies, procedures, and instructions identified in Appendix A apply to this


Addendum.

A-2.4 QAP Assessment

This Addendum is updated as determined by the Vice President, Quality &


Performance.

A-2.5 QAP Indoctrination and Training

Same as document Section 2.1.6 except documentation of qualifications for personnel


performing inspection, surveillance, and audit activities are not required.

A-3 DESIGN CONTROL

A-3.1 Scope

Design control measures are applied to non-safety related items and services as
defined in written procedures and instructions.

AREVA NP Inc. maintains design control only during the performance of contracted
work. Control of design configuration prior to and after completion of a contract is the
responsibility of the customer.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report AP-3
A-3.2 Design Documents

The cognizant technical manager is responsible for the preparation, review, and
approval of design documents for items and services within their respective areas of
expertise. Design documents include such documents as specifications, requirements
documents, drawings, and analyses. These documents specify technical and quality
requirements appropriate to the activities they cover.

Design documents are reviewed for completeness and technical accuracy. The
reviewer may be any technically qualified individual other than the preparer of the
document.

Spare or replacement items may be designed and procured to the original or equivalent
requirements. The requirements may be defined by the original specifications and/or by
AREVA NP Inc., the OEM, or the customer. Product specifications and drawings are
prepared, reviewed, and approved as stipulated in written procedures.

A-3.3 Design Interfaces

The preparers/reviewers of design documents are responsible to assure the


consideration of design interfaces. The project management function coordinates
design interfaces with the customer. The customer may assume responsibility for
specifying, reviewing for accuracy, and approving physical and functional interface, with
existing customer equipment and systems which affect the performance of AREVA NP
Inc. work. Alternatively, the customer may choose to contractually delegate this
responsibility to AREVA NP Inc. and, accordingly, furnish AREVA NP Inc. with adequate
records and documentation from which such interfaces can be defined.

A-3.4 Design Verification

The responsible technical manager and project management functions determine the
need for design verification. Verification methods include design analyses
(calculations), design review boards, and design verification testing.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report AP-4
A-3.4.1 Design Analyses

Design analyses (calculations) may be used to establish design requirements or to


verify a design. Calculations are documented and reviewed for technical accuracy. The
reviewer may be any technically qualified individual other than the preparer of the
calculation. Computer programs used for design analyses are verified to the extent
necessary to assure that they perform their intended functions.

A-3.4.2 Design Review Boards

Same as Document Section 3.6.3.

A-3.4.3 Testing

Testing is used to demonstrate that designs or design features are suitable for their
intended applications. The criteria for such testing is determined and documented in
written test procedures by the responsible technical manager. Test results are reviewed
by the responsible technical manager against this criterion.

A-3.5 Design Changes

Design changes are subject to the same design controls that were applicable to the
original design.

A-3.6 Engineering Assistance/Advice and Consultation

Same as Document Section 3.8.

A-4 PROCUREMENT DOCUMENT CONTROL

A-4.1 General

Controls are established by written procedures to assure that procurement documents


contain appropriate quality, technical, and manufacturing requirements.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report AP-5
A-4.2 Procurement Process

Purchasing Authorizations (PA) are used to identify the technical, quality, and other
requirements applicable to commercial items and/or services to be procured with limited
quality scope. PA’s are prepared, reviewed, and approved as prescribed in procedures.
Other commercial items/services may be purchased using purchase requisitions or
electronic requisitioning.

The project management function is authorized to procure items and/or services directly
from other AREVA NP Inc. organizations using the PA as the contract with these
organizations.

Orders placed with all other suppliers, including other AREVA NP organizations, are
processed through Purchasing. Purchasing converts the PA/PR into a Purchase Order
(PO) or Change Order (CO). The PO/CO is then sent to the supplier.

A-4.3 Procurement Document Review

Procurement documents, at the discretion of the project management function, may be


reviewed by QA to determine that requirements are correctly stated and that the
procurement is properly classified as non-safety related.

A-4.4 Changes to procurement Documents

Changes to procurement documents are processed in the same manner as the original
procurement documents.

A-5 INSTRUCTIONS, PROCEDURES, AND DRAWINGS

A-5.1 General

All activities affecting quality are prescribed by instructions, procedures, or drawings


appropriate to the circumstances and accomplished accordingly. Instructions,
procedures, and drawings include or reference adequate quantitative or qualitative
criteria for determining that important activities have been satisfactorily accomplished.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report AP-6
A-5.2 Administrative Policies, Procedures, and Instructions

This QAP is implemented through this Document Addendum, and written administrative
policies, procedures, and instructions. These policies, procedures, and instructions are
prepared by responsible personnel, reviewed by other organizations to whom they
apply, and then reviewed and approved by QA before they are approved and distributed
for use.

A-5.3 Drawings and Specifications

Drawings, specifications, and other documents are released for use in engineering,
procurement, manufacturing, and field activities as described in Section A-6.

A-5.4 Manufacturing, Inspection, and Test Plans

The responsible technical manager prescribes the applicable drawings, specifications,


and procedures to be used in the manufacture, inspection, and test of non-safety
related items.

A-6 DOCUMENT CONTROL

A-6.1 General

Design documents (calculations, drawings, specifications), procurement documents,


and instructions are prepared, reviewed, approved, and issued in accordance with
procedures or instructions.

Established procedures assure technical adequacy of, and inclusion of, appropriate
requirements in the above documents by requiring reviews by qualified reviewers prior
to their implementation. Changes to these documents are processed in the same
manner as the original documents.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report AP-7
A-6.2 Document Control System

Technical documents including design documents (drawings, instructions, test


procedures, customer supplied technical documents, etc.) relating to activities affecting
quality are maintained, controlled, and issued in a manner to assure the correct and
applicable documents are used at the location where the activity is performed.
Documents are maintained, stored, and released by Records Management.

A-7 CONTROL OF PURCHASED ITEMS AND SERVICES

Same as Document Section 7 with the following exceptions:

• The requirements of document Sections 7.1 – 7.5, and 7.8 do not apply unless
specifically requested by the organization requesting the product or service. It is
the responsibility of the requisitioning organization and/or purchasing to assure
that non-safety related items and services are procured from reputable suppliers
with known capability of providing the items or services being purchased.
• Incoming items received at AREVA NP Inc. for use in non-safety related
applications, at a minimum, undergo a visual inspection for shipping damage and
verification that the items received were the items ordered. Additional
requirements may be imposed by the responsible technical manager or by
contract.
• Certificates of Conformance/QA Data Packages are not furnished for non-safety
related items or services unless requested by the customer’s purchase order.

However, if required by contract, Certificates of Conformance (CoC) are prepared by


the responsible Unit Manager or designee for items provided by AREVA NP Inc. to
customers for their use. These CoC’s are signed by the responsible Unit Manager or
designee prior to shipment of the items.

A-8 IDENTIFICATION AND CONTROL OF ITEMS

The controls specified in document Section 8 can be applied when these controls are
identified by the responsible technical manager in appropriate drawings and design
documents.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report AP-8
A-9 CONTROL OF PROCESSES

The controls specified in Document Section 9 are invoked by the responsible technical
manager in accordance with the contract.

A-10 INSPECTION

Inspections of non-safety related items for acceptability are performed and documented
as specified by the responsible technical manager. Inspections may be performed by
any competent individual using measuring and test equipment (M&TE) calibrated and
controlled in accordance with Section A-12. Any nonconformances found during
inspections are processed as described in Section A-15.

A-11 TEST CONTROL

Tests of non-safety related items are performed and documented as specified in written
procedures by the responsible engineering function. M&TE used during the
performance of tests is calibrated and controlled as specified in Section A-12.

A-12 CONTROL OF MEASURING AND TEST EQUIPMENT

Same as document Section 12. However, the following exceptions may be utilized
provided M&TE for non-safety related items is segregated from M&TE for safety related
systems.

• M&TE may be calibrated against reference standards having an accuracy at


least that of the M&TE being calibrated.
• Suppliers of calibration services for M&TE need not be QA audited and approved
suppliers.

A-13 HANDLING, STORAGE, AND SHIPPING

Same as document Section 13 except tagging of stored items is not required.


AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report AP-9
A-14 INSPECTION, TEST, AND OPERATING STATUS

Inspection, test, and operating status will be recorded on applicable documentation.


Any competent individual may perform the functions of an inspector (see Section A-10).

A-15 CONTROL OF NONCONFORMANCES

Same as document Section 15.

A-16 CORRECTIVE ACTION

Same as document Section 16.

A-17 QUALITY ASSURANCE RECORDS

A-17.1 General

Procedures are established by AREVA NP Inc. to collect and retain records which
provide evidence that design, procurement, fabrication, inspection, testing and field
activities are in accordance with quality requirements. Requirements and
responsibilities for record generation, identification, accumulation, transmittal, retention,
and maintenance are contained in these procedures.

A-18 AUDITS

Audits of a specific project will be done as required by contract or as designated by the


Vice President, Quality & Performance. The following exceptions apply to audits:

• Certification of auditors to audit non-safety related work is not a requirement;


however, audits may be performed with the approval of the Manager, Quality
Audits and Programs.
• Suppliers for non-safety related applications need not be audited.

Non-safety related suppliers who are audited and certified by other quality organizations
is considered evidence of a quality system, i.e., ISO, DOE, DOD, and ASME.
AREVA NP Inc. ANP-10266
Revision 3
AREVA NP Inc. Quality Assurance Plan (QAP) for Design Certification of the U.S. EPR™
Topical Report AP-10
A-19 NONSAFETY-RELATED SSC’S 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.

AREVA NP Inc. implements 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.”

AREVA NP Inc. implements quality requirements to ATWS equipment in accordance


with Generic Letter 85-06, “Quality Assurance Guidance for ATWS Equipment that is
not Safety Related.”

AREVA NP Inc. implements 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.”

You might also like