AREVA NP Inc. Quality Assurance Plan (QAP) For Design Certification of The U.S. EPR™ Topical Report
AREVA NP Inc. Quality Assurance Plan (QAP) For Design Certification of The U.S. EPR™ Topical Report
AREVA NP Inc. Quality Assurance Plan (QAP) For Design Certification of The U.S. EPR™ Topical Report
Revision 3
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™
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:
Nature of Changes
Revision 03
Nature of Changes
Revision 02
Nature of Changes
Revision 01
Statement of Policy
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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
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Nomenclature
Acronym Definition
AF Audit Finding
CR Condition Report
CO Change Order
Acronym Definition
OI Operating Instruction
PA Purchasing Authorization
PO Purchase Order
PR Purchase Requisition
QA Quality Assurance
QC Quality Control
WI Working Instruction
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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
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.
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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.
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.
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.
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1.0 ORGANIZATION
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:
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™.
AREVA NP Inc. management is responsible to ensure that the size of the Quality
Assurance organization is commensurate with the duties and responsibilities assigned.
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The functions and responsibilities of the organizations of the Company which operate
under and implement the QAP are described as follows:
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.
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
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.
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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:
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.
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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.
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.
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.
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.
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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.
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.
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.
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EXHIBIT 1
EXHIBIT 2
R&S BG
HR Quality Finance
R&S BG
Legal I.S. Communications
Communications
Performance Improvement
Legal
Equipment Equipment
North America Support
Functions
EXHIBIT 3
Finance
SDCI Finance
SDCI
Human Resources
Human Resources
Processes, Methods & Tools
Internal Communication
Programs & Internal
Communications
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EXHIBIT 4
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
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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:
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
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.
• 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
This QAP establishes and maintains standards of quality through the development and
use of quality engineering and manufacturing practices, which are documented by
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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.
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.
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
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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.
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.
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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:
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
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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.
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.
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.
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.
All design documents are independently reviewed for completeness and technical
accuracy by a technically qualified individual other than the preparer of the document.
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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.
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.
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.
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.
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.
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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.
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
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.
Changes to procurement documents are processed in the same manner as the original
procurement documents.
Section 5.0, Instructions, Procedures and Drawings applies to the Design Certification
Project.
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.
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.
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:
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:
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
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.
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.
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.
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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:
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.
The acceptability of suppliers of safety related materials, items, or services are based
on the following items:
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.
to the Design Certification as no materials are being procured in the scope of the
project.
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
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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.
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.
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.
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
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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:
CoC’s are signed by the Vice President, Quality & Performance or designee.
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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.
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:
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.
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• 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 scope of the design certification project does not include fabrication, erection,
installation or use.
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:
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
9.3.1 Welding
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.
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.
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.
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,
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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.
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:
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
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.
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.
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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:
11.1 Purpose
This section applies to the testing of safety related items that are required to
demonstrate compliance with regulatory and contract requirements.
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11.2 General
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
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
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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.
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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:
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
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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
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.
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.
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:
The scope of the Design Certification Project does not include fabrication, erection,
installation or use.
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:
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
13.3.1 Cleanliness
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
The scope of the design certification project does not include fabrication, erection,
installation or use.
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:
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.
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.
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The scope of the design certification project does not include fabrication, erection,
installation or use.
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.
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15.3 Internal Nonconformances
15.3.1 Nonconformances
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.
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15.3.2 Safety Concerns
Internal and external audits may result in audit findings as described in Section 18 of
this QAP.
Supplier nonconformances enter the AREVA NP Inc. system in one of three ways:
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.
project management function for possible notification to the customer or submittal for
acceptance as prescribed in the customer’s contract.
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.
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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
Responsibilities within the Corrective Action program are not delegated. AREVA NP
Inc. maintains responsibility for the program’s effectiveness.
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16.3 Implementation
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:
The AREVA NP Inc. Records Management System also implements the requirements
of the following:
This section defines the requirements for the collection, retention and retrievability of
QA records for safety related items or services.
17.2 General
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
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17.3 Implementation
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.
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18.0 AUDITS
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:
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
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:
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
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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.
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.
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
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Evaluations of suppliers are documented and take into account the following, where
applicable:
The audit report is signed by the audit team leader and issued. The report includes the
following information as appropriate:
APPENDIX A
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
APPENDIX B
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.
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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.
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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
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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.
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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.
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APPENDIX C
Definitions
Acceptance Criteria
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
As-Built Data
Audit
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.
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.
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Computer Program (Code Software)
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
A material or component which has one or more characteristics that do not comply with
specified requirements.
Deficiency
Deviation
Document
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
Examination
Failures
Handling
Hold
Hold Point
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
Malfunctions
Non-Destructive Examination
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
Out of Commission
Procedure
Process
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
Qualification (Personnel)
Qualified Equipment
Equipment which has been evaluated by sufficient testing to assure performance within
specified parameters.
Quality
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.
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.
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.
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Reject
Repair
Review/Approval
Rework
Safety Related
Safety related items are the equipment that is relied upon to remain functional during
and following design basis events to ensure:
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
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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
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 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.
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Supplier
Surveillance
Testing
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
Waiver
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.
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ADDENDUM A
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
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).
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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-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.
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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.
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.
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A-3.4.1 Design Analyses
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.
Design changes are subject to the same design controls that were applicable to the
original design.
A-4.1 General
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.
Changes to procurement documents are processed in the same manner as the original
procurement documents.
A-5.1 General
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.
Drawings, specifications, and other documents are released for use in engineering,
procurement, manufacturing, and field activities as described in Section A-6.
A-6.1 General
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.
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A-6.2 Document Control System
• 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.
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.
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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.
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.
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.
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
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.
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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.