FUSION FOR ENERGY The European Joint Undertaking for ITER and the Development of Fusion Energy Doc. # F4E-QA-P_IO Q A IDM # F4E_D_11O3LZ Page 1 / 42 Rev. A0.5 Quality Management System QUALITY ASSURANCE PROGRAM For items and services provided by the EU-DA to the ITER project Abstract This document describes and establishes the overall framework to achieve the quality criteria for all ‘Fusion for Energy’ technical activities and in particular for safety relevant components and activities for the ITER project. The program described in this document is an integral part of the “Fusion for Energy’ Quality Management System. Version: 0.5 Date: MARCH 2008 Author: D.RODRIGUES 2008.03.31 Reviewer: IO QA, F.CASCI (PO), A.VOSTNER (MS/MG), R.MONK (OD), P.BARABASCHI (BA) Approver: D. GAMBIER (F4E Director) Effected changes from Revision W0.4 - Final draft agreed wit IO QA. - Internal F4E Revision, integrated comments/corrections. UNCONTROLLED WHEN PRINTED Printed copies of this document are considered for reference only. It is the responsibility of users to ensure that they are using the correct revision of this document by checking the document revision level with that held on the F4E IDM.
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FUSION FOR ENERGY The European Joint Undertaking for ITER and the Development of Fusion Energy
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Quality Management System
QUALITY ASSURANCE PROGRAM For items and services provided by the EU-DA to the ITER project
Abstract
This document describes and establishes the overall framework to achieve the quality criteria for all ‘Fusion for Energy’
technical activities and in particular for safety relevant components and activities for the ITER project.
The program described in this document is an integral part of the “Fusion for Energy’ Quality Management System.
Effected changes from Revision W0.4 - Final draft agreed wit IO QA. - Internal F4E Revision, integrated comments/corrections.
UNCONTROLLED WHEN PRINTED Printed copies of this document are considered for reference only. It is the responsibility of users to ensure that they are using the correct
revision of this document by checking the document revision level with that held on the F4E IDM.
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Table of Contents TERMS AND DEFINITIONS................................................................................................................................................................................5
1. INTRODUCTION......................................................................................................................................................................................................6 1.1. QUALITY ASSURANCE PROGRAM PROMULGATION......................................................................................................................6 1.2. SCOPE............................................................................................................................................................................................................6
3. FUSION FOR ENERGY..........................................................................................................................................................................................8 3.1. PRESENTATION...........................................................................................................................................................................................8
3.1.1. ABOUT F4E ................................................................................................................................................................................................. 8 3.1.2. PRODUCTS SUPPLIED TO THE ITER ORGANISATION..................................................................................................................................... 8
3.2. FUNCTIONS DESCRIPTION.......................................................................................................................................................................9 F4E Director ..................................................................................................................................................................................................10 Head of Department.....................................................................................................................................................................................10 Project Board (Senior Management Board, SMB)....................................................................................................................................11 F4E QA Responsible Officer (QA RO).......................................................................................................................................................11 Quality Assurance Officers (QAO)..............................................................................................................................................................11 Quality Assurance Board.............................................................................................................................................................................12
3.3. QUALITY ASSURANCE (QA) PROGRAM.............................................................................................................................................13 3.3.1. PROPOSE...................................................................................................................................................................................................13 3.3.2. STRUCTURE...............................................................................................................................................................................................13 3.3.3. REVIEW AND PROMULGATION.....................................................................................................................................................................14 3.3.4. REVISIONS AND ISSUES ..............................................................................................................................................................................14 3.3.5. DISTRIBUTION AND CONTROL.....................................................................................................................................................................14
Quality Objectives.........................................................................................................................................................................................19 QA Program Planning..................................................................................................................................................................................19
5.4.1. TRAINING....................................................................................................................................................................................................20 Training Requirements.................................................................................................................................................................................20 Task-Specific Training..................................................................................................................................................................................20 Qualification in Special Processes ..............................................................................................................................................................21
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5P
P ...............................................................................................................................
P
IO
ND DEVELOP
5.
n Change...............................................................................................................................
5.5.
ndard Items and S
E ...............................................................................................................................
/
M ...............................................................................................................................
C ...............................................................................................................................
A ...............................................................................................................................
M
5.6.
C
A ...............................................................................................................................
5.6.
.5. PROJECT MANAGEMENT.......................................................................................................................................................................21 5.5.1. ESTABLISHMENT OF ROCUREMENT ARRANGEMENT WITH IO....................................................................................................................21 5.5.2. IMPLEMENTATION LANNING ........................................22 5.5.3. DETERMINATION OF RODUCT REQUIREMENTS..........................................................................................................................................23 5.5.4. COMMUNICATION WITH AND OTHER DA’S...............................................................................................................................................23 5.5.5. RESEARCH A MENT (R&D)......................................................................................................................................................23
5.5.7. COMPUTER CODE & MODEL DEVELOPMENT..............................................................................................................................................26 8. PROCUREMENT AND GRANTS MANAGEMENT.............................................................................................................................................26
Identification of Needed Items or Services.................................................................................................................................................27 Establishment of Technical and Quality Requirements............................................................................................................................27 Evaluation and Selection of Suppliers ........................................................................................................................................................27 Monitoring of Supplier Performance ...........................................................................................................................................................28 Item Deviation from Requirements .............................................................................................................................................................28 Substa ervices................................................................................................................................................................28
5.14. MEASURING AND TEST EQUIPMENT..........................................................................................................................................................31 Calibration Labelling and Documentation...................................................................................................................................................31
.6. ASSESSMENT AND IMPROVEMENT....................................................................................................................................................32 5.6.1. IO EEDBACK ..............................................................32 5.6.2. QUALITY UDITS ..........................................................32 5.6.3. MONITORING AND EASUREMENT OF PROCESSES....................................................................................................................................32
4. INSPECTION AND TESTING...........................................................................................................................................................................33 Inspection ......................................................................................................................................................................................................33 Testing ...........................................................................................................................................................................................................33
5.6.5. NON ONFORMITY CONTROL......................................................................................................................................................................34 5.6.6. DATA NALYSIS ...........................................................35
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Preventive actions.........................................................................................................................................................................................35 ANNEX 1 – DOCUMENTATION FLOW PROCESS.....................................................................................................................................36 ANNEX 2 – CHANGE PROCESS FLOWCHART.........................................................................................................................................37 ANNEX 3 – QUALITY AUDITS PROCESS FLOWCHART.........................................................................................................................38 ANNEX 4 – QUALITY SURVEILLANCE PROCESS FLOWCHART.........................................................................................................39 ANNEX 5 – NONCONFORMITIES PROCESS FLOWCHART - DETECTED BY F4E/IO......................................................................40 ANNEX 6 - NONCONFORMITIES PROCESS FLOWCHART - DETECTED BY SUPPLIER...............................................................41
A & MANAGEMENT REQUIREMENTS................................................................................................................42
: Project Responsibilities......................................................................................................................................................22 Figure 6: Governance of the Management Relationships.............................................................................................................29
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TERMS AND DEFINITIONS
Audit (quality)
Systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled.
• Internal Quality Audit – audit performed to an internal (F4E) process or organisational entity • External Quality Audit - audit performed to an external (Supplier) process or entity
Change is a planned alternative to a specified requirement
Configuration baseline
A configuration of a product, formally established at a specific point in time, which serves as reference for further activities.
Corrective action action to eliminate the cause of a detected Nonconformity or other undesirable situation
DA Domestic Agency, an organisation appropriately formed and appointed within and by each “Party” to be the supplier of in-kind goods and services to the IO on the basis of defined specifications.
Economic operator
means a natural or legal person or public body offering the execution of work and/or supplies and/or services
F4E The European Joint Undertaking for ITER and the Development of Fusion Energy (Fusion for Energy)
FOR Field Observation Report
Grant or Procurement
An activity (or project) can be carried out by awarding: - A contract pursuant to a procurement procedure - A grant agreement pursuant to the procedure for awarding grants Both of these procedures are laid down in the F4E Implementing Rules of the Financial Regulation
IO ITER International Fusion Energy Organisation for the Joint Implementation of the ITER Project, the Customer who receives the items and services provided by the EU-DA to the ITER project
ITER ITER international fusion energy research project
ITER Agreement Agreement on the Establishment of the International Fusion Energy Organisation for the Joint Implementation of the ITER Project”
Nonconformity is any condition which does not comply with the requirements specified (ISO9000: Non-Fulfilment of a Requirement).
Parties the ITER “Parties” are the signatories of the Agreement on the Establishment of the ITER International Fusion Energy Organisation for the Joint Implementation of the ITER Project
Preventive action action to eliminate the cause of a potential Nonconformity or other undesirable potential situation
Product Supplies, services, works or results of R&D and demonstration activities provided by the F4E to the ITER project. “result of a set of interrelated or interacting activities which transforms inputs into outputs”
QA RO F4E Quality Assurance Responsible Officer
QAO Quality Assurance Officer (Department Level)
QMS Quality Management System
sub-contractor All agencies who supply items to the economic operator under a contract or grant agreement
Supplier
Economic operator that provides supplies, services or works described in the technical specification. The successful tenderer is referred in the document as the “supplier”. The supply-chain follows the scheme below
Supplier -> Organisation (F4E) -> Customer (IO)
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1. INTRODUCTION
1.1. QUALITY ASSURANCE PROGRAM PROMULGATION
The Quality Assurance Program described in this document has the approval and total support from the “Fusion for
Energy” Director.
The cooperation and support from all staff in performing all its activities according to the requirements defined in this
program are preponderant factors to the maintenance and improvement of the Quality Assurance Program, as well as to
the Organisation performance.
1.2. SCOPE
The program described in this document applies to all technical activities performed by ‘Fusion for Energy’ providing
Europe’s contribution to the ITER project; including activities performed by contracted or subcontracting qualified
economic operators.
This document does not cover the activities directly contracted by IO with EU labs and industry.
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2. QUALITY POLICY
‘Fusion for Energy’ expects the commitment of all its staff to guarantee that its activities are prepared and carried out
according to the established quality standards.
‘Fusion for Energy’ is committed:
• To ensure that all Fusion for Energy’ personnel is informed about the internally adopted Quality Management
System and all technical staff about Quality Assurance Program;
• To ensure that all personnel have clearly understood and are committed to their responsibilities and obligations;
• To ensure that the technical and management interfaces between ‘Fusion for Energy’ and IO are clearly stated
and understood;
• To ensure that the technical and management interfaces between ‘Fusion for Energy’ and its suppliers are
clearly stated and understood;
• To ensure that the established quality standards are prescribed and enforced when contracting with economic
operators;
• To guarantee that actions are adequate to ensure the health and safety of the workers and public, and the
reliable development of ITER machine;
• To periodically review the Quality Management System and adapt it in order to keep it simple and effective;
• To allocate adequate personnel and financial resources for the implementation of the Quality Management
System;
• To promote an attitude and create an environment favouring the continual improvement of the quality standards.
‘Fusion for Energy’ implements a simple and effective Quality Management System tailored to its specific activities and
customers. The Quality Management System is based on the implementation of project management good practices in
order to comply with the customer requirements (IO).
The ‘Fusion for Energy’ Quality Management System implements, for safety relevant components and activities, the
requirements of the ‘Order of August 10 – 1984’ (French Republic ‘Arrêté du 10 Août 1984’) and in general uses as basis
the IAEA Safety Requirements GS-R-3 (2006) and ISO 9001:2000 as applicable.
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3. FUSION FOR ENERGY
3.1. PRESENTATION
3.1.1. ABOUT F4E
The European Joint Undertaking for ITER and the Development of Fusion Energy (‘Fusion for Energy’) is a type of
European organisation known as a Joint Undertaking created under the Euratom Treaty by a decision of the Council of
the European Union.
'Fusion for Energy' is established for a period of 35 years from 19th April 2007 and is situated in Barcelona, Spain.
‘Fusion for Energy’ has the following Members:
(a) the European Atomic Energy Community (hereinafter “Euratom”);
(b) Member States of Euratom;
(c) third countries which have concluded a co-operation agreement with Euratom in the field of controlled nuclear
fusion that associates their respective research programmes with the Euratom programmes and which have
expressed their wish to become Members of the Joint Undertaking (hereinafter “Associated third Countries”).
The objectives of the ‘Fusion for Energy’ are:
(a) to provide the contribution of Euratom to the ITER International Fusion Energy Organisation (“the ITER
Organisation”), in accordance with the Agreement on the Establishment of the ITER International Fusion Energy
Organisation for the Joint Implementation of the ITER Project (“the ITER Agreement”);
(b) to provide the contribution of Euratom to broader approach activities with Japan for the rapid realisation of fusion
energy (“Broader Approach Activities”), in accordance with the bilateral Agreement for the Joint Implementation
of Broader Approach Activities (“the Broader Approach Agreement with Japan”);
(c) to implement a programme of activities in preparation for the construction of a demonstration fusion reactor and
related facilities including the International Fusion Materials Irradiation Facility (IFMIF).
3.1.2. PRODUCTS SUPPLIED TO THE ITER ORGANISATION
As the European Domestic Agency for ITER, the ‘Fusion for Energy’ shall discharge the obligations of Euratom to the
ITER Organisation as defined in, and for the duration of, the ITER Agreement. In particular, it shall:
a) Oversee preparation of the ITER site;
b) Provide components, equipment, materials and other resources to the ITER Organisation;
c) Manage procurement arrangements vis-à-vis the ITER Organisation and in particular associated quality
assurance procedures;
d) Prepare for and coordinate Euratom’s participation in the scientific and technical exploitation of the ITER Project;
e) Provide for the implementation of scientific and technological research and development activities in support of
Euratom’s contribution to the ITER Organisation;
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f) Provide Euratom’s financial contribution to the ITER Organisation;
g) Provide arrangements to make human resources available for the ITER Organisation;
h) Interface with the ITER Organisation and carry out any other activities in furtherance of the ITER Agreement.
Activities covered by the QA Program under these activities include:
• R&D (Research and Development) and demonstration activities;
• preliminary and / or detailed design of components and systems;
• development of manufacturing and testing methods;
• manufacturing, construction or integration of components and systems;
• development of assembly, inspection, maintenance tools and procedures;
• development of new technologies of direct application to ITER machine;
• development and validation of software for specific ITER applications;
• development of safety analyses and software;
• preparation / adaptation of technical specifications for tenders, standards and codes;
• development and qualification of materials and technologies for possible applications in ITER;
• design, building, commissioning and operation of new test facilities for ITER material / components / systems;
In general, items and services are provided by assigning the relevant activities to qualified economic operators through
contracts (or grant agreements), according to the legal framework laid down inter alia by the financial regulation of ‘Fusion
for Energy’ and its implementing rules.
Reference and Applicable Documents
F4E CD Council Decision No. 2007/198/Euratom of 27 March 2007 establishing the European Joint Undertaking for ITER and the Development of Fusion Energy and conferring advantages upon.
F4E(07)-GB03-11 “Decision adopting the Financial Regulation of the Joint Undertaking”
F4E(07)-GB03-12 “Decision adopting the Implementing Rules of the Financial Regulation of the Joint Undertaking”
3.2. FUNCTIONS DESCRIPTION
This subsection describes the functions with direct responsibility in the management and maintenance of the Quality
Assurance Program for items and services provided by the F4E to ITER.
Responsibility for quality starts from the top with the ‘Fusion for Energy’ Director and the Heads of Departments and
permeates through the entire organisation. Each Project Manager and Work Package Manager involved in the activities
is responsible for the quality of his own work and that of his subordinates.
Implementation of Quality Assurance is the daily responsibility of all persons. It is part of their professional duties to ensure
that the activities each person is responsible for, are compliant with all applicable requirements of the Quality
Management System and that the procedures given herein are followed.
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Particular attention is drawn to a correct documentation of the construction process, from the design phase to the in-situ
commissioning. This must be done with the tools described in the Quality Management System standards, in order to
ensure availability of the relevant information and traceability of the end product over the whole project lifetime.
Suppliers are bound to follow the Quality Management System for their work. They provide a dedicated Quality Plan that
describes the quality provisions to be implemented in order to comply with the ‘Fusion for Energy’ quality requirements.
Once approved by ‘Fusion for Energy’, it can be used and is physically transferred to ‘Fusion for Energy’ at the end of the
collaboration in order to ensure traceability of the delivered products over the whole project life.
Heating, CD & Plasma Engineering Division
Site, Buildings and Power Supplies
Machine Systems Division
Engineering Support Division
Project Office(Planning, QA, Config Man.)
Suppliers Relations and Reporting
Procurement Support
Budget, Finance and Accounting
Human Resources
IT Systems
IFMIF
JT60-SA
IFERC
DEMO
Internal Audit
Office of the Director - Secretariat for F4E bodies and Committees - Quality Assurance - Legal Advice - International Agreements - Press, Public and External Relations - Interinstitutional Relations
Magnet Systems
Vacuum Vessel
In Vessel
Remote Handling
Legal Support, IPR and Technology Transfer
Infrastructure and Logistics
Information and Communication
Plant Systems Division
Cryoplant
Vacuum and Tritium Systems
Test Blanket Modules
Materials Development
Drawing office
Materials & Fabrication
Analysis & Codes
Safety
Diagnostics
Heating & Current Drive
Plasma Engineering
CODAC
F4E Director
ITERDepartment
Broader Fusion DevelopmentDepartment
Contracts and ProcurementDepartment
ResourcesDepartment
Figure 1: Operational Structure
F4E Director
The Director is the chief executive officer responsible for the European in-kind deliveries to ITER and for the day-to-day
management of the ‘Fusion for Energy’ and is its legal representative.
The Director implements the work programmes and directs the execution of the activities. He supplies the Governing
Board, the Executive Committee, the Scientific Programme Boards and any subsidiary bodies with all information
necessary for the performance of their functions.
The ‘Fusion for Energy’ Director assumes the overall responsibility for quality implemented into ‘Fusion for Energy’.
Head of Department
Each Department is headed by a ‘Head of Department’ nominated by the ‘Fusion for Energy’ Director.
The Head of Department is responsible for:
• the management of the staff including the resource control for his Department;
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• the proper achievement of the activities (approved work proposals) from the endorsed Work Programme, which
are in the scope of his Department;
t and its submission to the ‘Fusion for Energy’
eal with all the main
-ordination between the
es and their interfaces with the outside.
ent Board.
ity Assurance issues and discuss actions
f departments and the QA Responsible Officer (or their representatives)
and
definition, to coordinate its
esponsible officers of 'Fusion for Energy' in QA matters;
nd its suppliers;
s to 'Fusion for
internal QA Officers, QA representatives and associated staff.
es (after consultation with the Deputy for Quality Assurance). These Quality Assurance Officers should be
tment and have the freedom to identify problems
• the definition of the basic organisational structure of the departmen
Director for approval;
• the nomination of the responsible officers on dedicated work.
Project Board (Senior Management Board, SMB)
The ‘Fusion for Energy’ senior management has regular meetings (Project Board) in order to d
concerns of ‘Fusion for Energy’ (scientific, financial, legal, programmatic, strategic…), the co
different departments, their internal implementation of activiti
Co-ordination between the different departments is ensured by the Senior Managem
The main objectives of the Project Board are (quality wise):
• Regular review of the Quality Management System (at least once a year)
• Assess the 5 top level Qual
The Project Board is composed by the heads o
is chaired by the F4E Director.
Meetings frequency is defined by the Director.
F4E QA Responsible Officer (QA RO)
The ‘Fusion for Energy’ Director appoints a member of the “Office of the Director” as his Deputy for Quality Assurance.
The missions of the QA Responsible Officer (QA RO) are:
• To assist the Director of ‘Fusion for Energy’ in the Quality Management System
development and implementation, to control its application and propose its evolutions;
• To advise managers and r
• To carry out audit and assessments of the quality management system implementation within ‘Fusion for
Energy’ a
• To establish effective working relationships with QA representatives of IO and of the supplier
Energy';
• To coordinate the QA effort of the
The QA Responsible Officer reports directly to the ‘Fusion for Energy’ Director.
Quality Assurance Officers (QAO)
Each Department, collaborating supplier, etc., shall designate sufficient number of Quality Assurance Officers, according
to their activiti
knowledgeable and experienced persons in Quality Management and in the work to be performed by their own
department.
The QA Officers have the authority to access work areas of the depar
that could result in a degradation of quality and to propose corrective actions.
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The main missions of the Department’ Quality Assurance Officers are:
• Support the F4E QA Responsible Officer in the relationship with QA representatives of IO;
To support the implementation of the ‘Fusion for Energy’ quality system; •
and reporting to the Quality Assurance Board
agement System implementation;
nd templates.
pecification and in the management specification
e nonconformities and changes of the contracts.
f the QA Board is to prepare, review and monitor the Quality Management System.
ce officers of the
departments.
The QA Board reports to the ‘Fusion for Energy’ Director, and informs other boards whenever needed.
o To implement the Quality Management System in ITER
of activities, problems and status related to Quality Man
o To provide needed quality procedures a
• To support the project managers and work package managers:
o To monitor the QA activities follow-up;
o To manage the relationship with the suppliers QA Officers;
o To integrate quality requirements in the technical s
issued to suppliers, together with the QA Responsible Officer;
o To assess QA plans provided by the task suppliers;
o To manage th
The ITER QA officers report directly to the Head of Project Office Division.
Quality Assurance Board
Co-ordination between the different QA officers is ensured by the Quality Assurance Board.
The mandate o
The QA Board is headed by the QA Responsible Officer and is composed by the Quality Assuran
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F4E QA Responsible Officer
ITER Dep.QA Officers
Broader Fusion Devolopment Dep.
QA Officers
Contracts and Procurement Dep.
QA Officer
Resources Dep. QA Officer
ContractorQA
Representative
Contractor 2QA
Representative
IOQA Officer
Co-ordination by QA Board
OUT OF SCOPE OF THIS QA Program
Figure 2: QA Co-ordination
Reference and Applicable Documents
F4E-QA-002 "Organisation and Responsibilities" procedure
3.3. QUALITY ASSURANCE (QA) PROGRAM
3.3.1. PROPOSE
, to evaluate and to continuously improve the
same approach as outlined in ISO 9001-2000 and in IAEA Safety
the quality of the
to the ITER
This document will allow ‘Fusion for Energy’ to act as an IO supplier with respect to French Nuclear Regulation.
ecessary, by a set of documents that specify the activities or tasks to perform (“what”,
“who”, “where”, “when”, and “how” are performed the activities/tasks).
ment is part of the F4E Quality Management System, and describes the specific quality management
system established for managing the activities which relate to items and services provided to the ITER project.
The QA Program provides the overall framework to establish, to execute
quality management system following the
Requirements GS-R-3 (2006) ”The Management System for Facilities and Activities” in order to ensure
in-kind items and services which relates to the business executed in ‘Fusion for Energy’ according
Agreement.
The present document defines the organisational structure of the organisation, the documental structure of the QA
Program and is supported, as n
3.3.2. STRUCTURE
The present docu
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This ntify the main themes. These are sub-divided by subsections and their
ganisation and management.
in the quality assurance are identified in this section
• Section 4 describes F4E provisions to comply with the quality requirements
The QA Responsible Officer has the responsibility to keep the master version on the F4E document server updated and
inform the senior management.
The master version being an electronic document, the QA Responsible Officer must assure its protection against any
undue change or any change that does not comply with the procedure F4E-QA-005 - Information Documents and
Records Control.
3.3.4. REVISIONS AND ISSUES
The evolution of the Quality Management System and the QA Program implies revisions to the sections of the QA
program. Effected changes from the last revision are registered on the front page.
The revision state is identified and will be changed whenever the program is partly or totally reviewed by the senior
management. This decision is made by the Director whenever needed.
3.3.5. DISTRIBUTION AND CONTROL
The responsible for the preparation of the QA Program is the QA Responsible Officer.
Printed copies of the QA program are considered for reference only.
It is the responsibility of users to ensure that they are using the correct revision of this document by checking the
document revision level with that held on the F4E document server (master version).
document is organised by sections that ide
points:
• Section 1 describes the scope of the Quality Assurance Program
• Section 2 presents the Quality Policy
• Section 3 gives a summary of F4E, presents the QA program or
The functions/entities that have direct influence
3.3.3. REVIEW AND PROMULGATION
The Quality Assurance Program is reviewed by the QA Responsible Officer and the senior management, its approval
and promulgation is the competence of the Director.
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4. PROCESSES INTERACTION
The F4E Quality Management System (QMS) is customer oriented, taking into account equally:
• the requirement definitions;
• the customer feedback;
• F4E compliance with the requirements
The QMS will be more efficient as its capacity to meet these requirements grows. This way the efficiency of the QMS is
continually assessed and measured through the monitoring indicators of processes and the fulfilment of the specified
Objectives.
The processes interaction in F4E is represented in the figure bellow.
CONTINUAL IMPROVEMENTASSESSMENT AND MONITORINGPROJECT MANAGEMENT PLANS
Project Management
Procurement & Grants Management
Nonconformity Control andCorrective/Preventive Actions
Configuration Management andChange Control
Risk Management
Quality Audits (External)
Quality Surveillance
Resources Control
Organization and Responsibilities
Information Documents and Records Control
Quality Audits (Internal)
Quality Classification
MANAGEMENT PROCESS
Interested Parties (IO)
Com
pliance SatisfactionIn
tere
sted
Par
ties
(IO)
Req
uire
men
ts
Figure 3: Processes Interaction
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5. QUALITY ASSURANCE SYSTEM
5.1. GENERAL REQUIREMENTS
This QA Program is structured and adapted to the specific type of activity of ‘Fusion for Energy” providing items and
services to the ITER project, having as objective to establish a relationship between organisational structures,
procedures, processes and other associated resources.
The implementation and evolution of the QMS, and in particular the QA Program, lays on a continual improvement
methodology, in which, the actions “plan”, “do”, “check” and “act” are inherent to a global vision of all activity
performances, according to the following steps:
• Quality Policy and Objectives: establish the Quality orientations and intentions;
• Planning – identify the processes and their application within the organisation, the sequence an interaction of
them, identify the risks associated, evaluate the risks, establish the criteria and method to ensure that the
operation, control and monitoring of the processes are effective;
• Execute and Implement – realization of the established activities;
• Monitor, analysis and corrective actions – measure the performance of the QMS and prevent the occurrence of
nonconformities, providing the necessary resources and information;
• Continual Improvement – implement the necessary actions to achieve planned results and the continual
improvement of these processes.
To ensure the control over any subcontracted process, the subcontract shall be awarded according to the procedure
“Procurement and Grants Management” and implemented following the procedure “Project Management”.
5.1.1. QUALITY CLASSIFICATION
Quality Assurance levels to be applied to items shall be tailored to their safety and impact importance. In particular,
grading of quality requirements (including nuclear safety) shall be applied in accordance with the quality classification
defined in the procedure “Quality Classification” compatible with the ITER Quality Classification.
The quality classification of a given procurement package or sub-package should be defined in the associated
procurement arrangement.
Reference and Applicable Documents
F4E-QA-010 "Quality Classification" Procedure
5.2. DOCUMENTATION
The prepared QMS documentation constitutes and added value to F4E, as it provides the statement of intent and
consequently assures the consistency of actions to develop.
Thus provide the information necessary for the maintenance of the QMS and training schemes developed, even
assuming an essential role for the proper planning and implementation of the necessary corrective actions.
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The Quality Management System documentation is organised according to the hierarchic levels defined in the figure
below.
The term document refers to information and the medium that is used to bring it into existence. A document can be
digital or physical (e.g. specifications, quality manuals, quality plans, records, and procedure documents).
PROCEDURES
INSTRUCTIONS
RECORDS & FORMS
EXTERNAL DOCUMENTATION
QUALITYMANUAL
QAPROGRAM
Figure 4: Documentation Hierarchy
Quality Manual – document that provide consistent information, both internally and externally, about ‘Fusion for Energy” Quality Management System. QA Program – document that describes F4E provisions from the QMS to comply with the ITER project requirements. Procedures - documents that provide information about how to perform the Organisation activities and processes consistently. Instructions (Work Instructions) - documents that provide information about how to perform the task activities and processes consistently. Records - documents that provide objective evidence of activities performed or results achieved.
External Documentation – documents of external origin and relevant to the Quality Management System.
This Quality Assurance Program and all the quality documents cover all ‘Fusion for Energy’ activities for the ITER project.
The preparation, maintenance, review, approval and distribution of quality documentations are described in F4E-QA-005.
This process ensures:
• that every actor “needing to know” (‘Fusion for Energy’, IO or Supplier), has ready access to all the up to date
information he needs to perform his task;
• that all documents and records are properly identified, approved, distributed and stored;
• that all quality documents are:
o archived for appropriate time;
o protected;
o well-preserved;
o easily accessible.
• that associated to the “Configuration Management and Change Control” and “Nonconformity Control”
processes, all the needed documents and records are available in order to allow:
o evidence that nuclear safety requirements are fulfilled;
o traceability of activities and results performed in the course of the tasks;
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o traceability of the deviations between deliverables and requirements.
Reference and Applicable Documents
F4E-QA-005 "Information Documents and Records Control" Procedure
F4E-QA-006 "Configuration Management and Change Control" Procedure
Nonconformity is a non-fulfilment of a requirement. This requirement might come from the procedures, the items and
services specifications or from the IO feedback.
All F4E personnel are responsible for the identification and reporting of any nonconformity detected.
F4E has proced Actions) for handling all aspects of the
detected nonconformities.
y F4E or IO, in Annex 5;
ties detected by the supplier, in Annex 6;
R Appl
F4E-QA-008 “Nonconformity Control and Corrective/Preventive Actions”
defined a ure (Nonconformity Control and Corrective/Preventive
The Nonconformity process within F4E is described in the following flowcharts:
• Process flowchart for nonconformities detected b
• Process flowchart for nonconformi
eference and icable Documents
F4E-QA-218-R “Nonconformity Report” Form
Applicable process flowchart
F4E-QA-P-An 5 F4E-QA-008 - Nonconformities detected by F4E or IO
F4E-QA-P-An 6 F4E-QA-008 - Nonconformities detected by the supplier
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5.6.6. DATA ANALYSIS
The QA Officers collect and analyse the appropriate data to determine the adequacy and effectiveness of the QMS and
QA Program, and can therefore identify improvements that could be made. This process includes data generated by the
activities of measurement and monitoring and / or other sources deemed relevant.
The analysis results taken to the QA Board for review and an annual report is prepared for the senior management
review.
5.6.7. CONTINUAL IMPROVEMENT
The Director shall continually improve the QMS, by planning and managing the necessary processes. The continual
improvement is achieved through the use of the Quality Policy, the Objectives, audit results, data analysis, corrective and
preventive actions and management review.
Corrective actions
The corrective actions are triggered by the occurrence of nonconformity, in order to eliminate the cause and prevent
repetition. It is included in the process of the corrective actions:
• The definition and elimination of causes of nonconformities;
• The appropriate actions to prevent the recurrence of problems;
• Records of activities and results.
Reference and Applicable Documents
F4E-QA-008 “Nonconformity Control and Corrective/Preventive Actions”
Preventive actions
The preventive actions are identified and adequate to eliminate the cause of a potential nonconformity or other
undesirable potential situation, preventing its occurrence.
Reference and Applicable Documents
F4E-QA-008 “Nonconformity Control and Corrective/Preventive Actions”
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ANNEX 1 – DOCUMENTATION FLOW PROCESS
FUSION FOR ENERGY
FLOW OF DOCUMENTATION
IO ACTIVITIESFUSION FOR ENERGY ACTIVITIESRESPONSIBLE
AUTHOR (ORIGINATOR)
IO
AUTHOR (ORIGINATOR)
AUTHOR (ORIGINATOR)
APPROVER
ADMINISTRATION
REVIEWER
AUTHOR (ORIGINATOR)
YES
NO
3.Review COMMENTS?
END OF DOCUMENT FLOW PROCEDURE
START OF DOCUMENT FLOW PROCEDURE
1.Draft Document Preparation or
Review Change
2.Document REVIEW
5. Document APPROVAL
6.APPROVAL?NO
YES
Document COMMENTby IO
IO COMMENTS?
YES
Final ACCEPTANCEby IO
IO APPROVAL?
YES
NO
4. EXTERNAL REVIEW
REQUIRED?
NO
NO
YES
7.EXTERNAL APPROVAL REQUIRED?
NO
YES
9.ARCHIVE ORIGINAL & UPDATE
DOC PLAN
10.DOCUMENT NEEDS
CHANGES?
NO
YES
8. FINAL RELEASE TO CUSTOMER
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ANNEX 2 – CHANGE PROCESS FLOWCHART RESPONSIBLE DOCUMENTFUSION FOR ENERGY ACTIVITIES
FUSION FOR ENERGY ACTIVITIES
IO ACTIVITIES
IO ACTIVITIES
Change Request Closed
Frozen Specification Requirements
START OF CHANGE MANAGEMENT PROCEDURE
2.DRAFT CHANGE REQUEST
NO YES
5.Change of CUSTOMER requirement?
11.CHANGE REQUEST
APPROVED?
YES
12.Establish Work Plan with resources
and schedule
13.CHANGES IMPLEMENTATION
14. UPDATE Specification
Requirements
END OF CHANGE MANAGEMENT PROCEDURE
6.Issue Internal CHANGE REQUEST
Disposition of CHANGE
10.Send to CUSTOMER RO
1.Identify Problem/Improvement
RequestIO CHANGE NOTICE
8.Change Beneficial?
(Conference CUSTOMER)
YES9.Issue
CHANGE REQUEST
NONo Change
7.Technical Review of Proposed Change
NO
No Change
4.IMPACT ANALYSIS3.IMPACT ANALYSIS
UPDATE Specification Requirements
IMPACT REPORT
Acceptance
YES
NONo Change
Change Notice
Draft CR
Impact Report
Change Request
Disposition
Work Plan
Updated SpecificationWPM
Project/Contract Management
Customer
Review Group(in Man. Plan)
Project/Contract Management
WPM
PM/WPM
WPM+ Integration
WPM
Competent Person
Disposition
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ANNEX 3 – QUALITY AUDITS PROCESS FLOWCHART RESPONSIBLE DOCUMENT GUIDANCEACTIVITY
START PROCESS
1.Plan Audits
2.Prepare Audit
3.Notify Entity to be Audited
4.Confirm Audit Dates
5.Kick-Off Meeting
6.Conducte Audit
8.Issue Report
9.Distribute Report
10.Start Corrective Actions Process
11.Close Nonconformities
12.Archive Records
QA RO[SMB / QA
Board]
External Audit Plan
(F4E-QA-214-1)
Audit Check List
(F4E-QA-214-2)
Audit Notification
(F4E-QA-214-3)
NRC(F4E-QA-218-R)
7.Closure Meeting
Audit Report(F4E-QA-214-R)
NCR(F4E-QA-218-R)
Audit Team
Audit Team
Audit Team
Audit Team
Audit Team
Audit Team
Audit Team
Audit Team
Auditee[QA RO]
QA RO
Closure RO / QA RO
-Make Internal Audit Plan, 6m forecast (Approval QA Board)-Make External Audit Plan, 6m forecast (Approval SMB)-Use qualified auditors (depend on availability and audit scope)-Consider all QMS processes and areas-Update plan when unforseen audits are necessary (QARO)-Spread within F4E
-Review Auditee Documentation-Prepare Check List
-Notify auditee entity/section Leader, 5 working days before the scheduled date
-Confirm with auditee entity/section Leader the dates
-the Audit team performs the kick-off meeting, presenting the team and the audit objectives, confirming the notification program.If necessary, conciliate dates and schedules
-Perform Interviews-Review Documents and records associted with the process or auditee entity/section-Register all findings-During the interviews, verbaly inform the auditee of the findings
-Perform a brief resume of the findings to the entity/section Leader with the same presences as in the kick-off meeting
-Issue Audit Report including: * strong areas * improvement areas * findings-Formalise eventual Nonconformities (NCR), following procedure QA-008
-Deliver a copy of the report to auditee entity/section Leader within 5 working days after the Closure Meeting.-Send copies to the QA RO
-The DQA and the auditee entity/section Leader should meet within 5 working days after the report delivery to define the Corrective and Preventive Actions-Fill the "Corrective / Preventive Action" field of the NCR form (QA-008-R)
FINISH PROCESS
-After the corrective action implementation period (stated), verify if it was implemented and its effectiveness. -The effectiveness verification is done when it does not reoccur within 3 months after implementation
-After the Nonconformity is closed, the responsible for closure sends the original of the Nonconformity Report to the QA RO
Internal Audit Plan
(F4E-QA-214-1)
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ANNEX 4 – QUALITY SURVEILLANCE PROCESS FLOWCHART RESPONSIBLE DOCUMENT GUIDANCEACTIVITY
START PROCESS
1. Identify need for Quality Surveillance
2. Appoint Surveillance Team
3.Notify Entity to be Surveilled
4.Prepare Surveillance
5.Conducte Surveillance
6.Issue Surveillance Report
8.FollowUp FOR issued
9.Raise NCR if needed
10.Verify Corrective Accions Process
11.Close Nonconformities
12.Archive Records
Surveillance Report
(F4E-QA-220-R)
7.Distribute Report
FOR(F4E-QA-211)
NCR(F4E-QA-218-R)
Surveillance Team
Surveillance Team
Surveillance Team
Surveillance Team
Surveillance Team
Audit Team
QA RO / PM / WPM
Audit Team
QA RO
Closure RO / QA RO
Scheduled Surveillance, as Previewed in: - Project Management Plan - Control Plan (or detail ITP)Unscheduled Surveillance: - on identifying an adverse or possible adverse condition
-Select Appropriate Team (1 or more members)-Selected personal must be knowledgeable about, and not directly responsible for, work under surveillance
-Notify entity/section responsible, within the agreed time frame before the scheduled date
-Prepare surveillance (plan surveillance points in the report form) should consider observation of important or critical work activities or process, as well as overall QA program implementation
-Perform surveillance and monitoring-Review Documents and records associted with the process or surveyed entity/section-Register all findings and verbaly inform the surveyed responsible of the findings.
-Issue Surveillance Report-Formalise eventual discrepancies by issuing a Field Observation Report (QA-211), indicating: * Impact (Safety, Quality, Cost, Schedule) * Status (Info, Response Required or NCR issue) * Describe Discrepancy * Propose solution/advice
-Deliver a copy of the report and associated FOR's to surveyed entity/section responsible within 5 working days after the surveillance date-Send copies to the QA RO
-Verify that the Notified entity replys with 5 working days-If FOR status is "NCR issue" then: * require that the entity raises an NCR * follow up it's progress until closure
-If entity does not raise NCR for required "NCR issue" then Formalise Nonconformity (NCR), following procedure QA-008
-The surveillance team and the surveyed entity/section responsible should meet within 5 working days after the report delivery to define the Corrective and Preventive Actions-Fill the "Corrective / Preventive Action" field of the NCR form
FINISH PROCESS
-After the corrective action implementation period (stated), verify if it was implemented and its effectiveness. -The effectiveness verification is done when it does not reoccur within 3 months after implementation
-After the Nonconformity is closed, the responsible for closure sends the original of the Non-Conformity Report to the QA RO
PMP(F4E-QA-205)
Control Plan(detail ITP)
QA RO / PM / WPM
QA RO / PM / WPM
FOR(F4E-QA-211)
Surveillance Report
(F4E-QA-210-R)
NCR(F4E-QA-218-R)
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ANNEX 5 – NONCONFORMITIES PROCESS FLOWCHART - DETECTED BY F4E/IO RESPONSIBLE DOCUMENT
FUSION FOR ENERGY ACTIVITIES CUSTOMER ACTIVITIES
FUSION FOR ENERGY ACTIVITIES CUSTOMER ACTIVITIES
Activity can be initiated by Customer or F4E
Nonconformity stays open
On going Process(Inspection, Test, Design, …)
START OF PROCEDURE
2. HOLD PROCESS
4.Segregate item NC and Identify
YES
NO
3.Process involves Product
6.MAJOR NC?
YES
NO
8.Decision on Corrective/ Preventive Actions
F4E Minor NC-LIST9.Record NC in NC-LIST
10.Implement CORRECTIVE/
PREVENTIVE ACTION
Nonconformity opened
Nonconformity closed
11.Completition and Control of the Correction
Actions
END OF NONCONFORMITY PROCEDURE
5.Issue NC REPORT
APPROVEDCorrective/
Preventive Action
F4E Minor NC-LIST
Customer copy
Nonconformity stays open
7.Send to CUSTOMER RO
C
Reject (Scrap), Repair, Rework, Use-As Is
C
C
1. Detect/Identify NC(Requirement not fulfilled)
Indentification TagWPM
QA Officer
WPMQA Officer
All Personel
Nonconformity Report
WPM
PM + WPM
Major NCLIST
Corrective/ Preventive
Action
Minor NCLIST
Corrective/ Preventive
Action
PM +Affected WPM
WPM
WPM
QA Officer ClosedNCR
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ANNEX 6 - NONCONFORMITIES PROCESS FLOWCHART - DETECTED BY SUPPLIER
RESPONSIBLE DOCUMENTSUPPLIER ACTIVITIES FUSION FOR ENERGY ACTIVITIES CUSTOMER ACTIVITIES
CUSTOMETIES R ACTIVITIESSUPPLIER ACTIVI FUSION FOR ENERGY ACTIVITIES
1.F4E YESMAJOR
NC?
NO
Supplier
3.Decision on Corrective/Preventive
Actions
4.Inform SUPPLIER of CORRECTIVE/
PREVENTIVE action to implement
APPrrec ction
ROVEDCo tive A
2.Forword SuCUSTOM
pplier NC to ER RO
C
C
SUPPLIER RAISES MAJOR
NONCONFORMITY
Implement
WQA
PMOfficer NCR
CORRECTIVE/ PREVENTIVE
ACTION
Completition and Control of the
Correction Actions
Send SUPPLPAffected WPM
M + IER NC to F4E RO
Corrective ActionPM + WPM
Corrective ActionC
Reject (Scrap), Repair, Rewo Is
Crk, Use-As
WPM
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UANNEX 7 – MAIN IO QA & MANAGEMENT REQUIREMENTS
IO Requirement QA Program match QA P Related Documents