IN-PILE CREEP RELAXATION AND POST-IRRADIATION THERMAL CREEP TESTING

Transcription

1 Page 1 / 11 Ver. 1.3 MANAGEMENT SPECIFICATION FOR THE IN-PILE CREEP RELAXATION AND POST-IRRADIATION THERMAL CREEP TESTING Abstract This document specifies the management requirements: the Supplier shall comply with during the course of the In-pile creep relaxation and post-irradiation thermal creep testing contract.

2 Page 2 / 11 Ver. 1.3 Table of Contents 1. Introduction Supplier Quality Plan Control Plan Submission of Plans F4E s acceptance Quality Plan Scope Structure System Compliance part Implementation Plan part Quality Plan Update and Validation Specific Requirements System Compliance Implementation Plan... 11

3 Page 3 / 11 Ver. 1.3 TERMS AND DEFINITIONS Term Definition Acronym Acceptance Data Package Contract The package of documents linked to each deliverable set out in the Technical Specification to be submitted by the Supplier for review by F4E. The Contract can be: The supply or service Contract as result of a procurement, or The Grant Agreement Fusion for Energy The European Joint Undertaking for ITER and the Development of Fusion Energy. IO or ITER The ITER International Fusion Energy Organisation. IO QA Quality Assurance QA QA Programme Quality Classification F4E s QA Programme, as set out in Reference Document F4E-QA-P-IO: Quality Assurance programme for items and services provided by the EU-DA to the ITER project. F4E s Quality Classification procedure, as set out in Reference Document F4E-QA-010: Quality Classification. SIC Safety Important Class (as defined in the French Quality Order 10 August 1984) --- Subcontractor All economic operators who supply items to the Supplier under the Contract. --- Supplier The Supplier is either: - the Contractor as defined in the supply or service Contract, or - the Beneficiary as defined in the Grant Agreement. The supply-chain follows the scheme below Supplier -> Organization (F4E) -> Customer (e.g. IO ) WBS Work breakdown structure WBS Work The specified necessary production, manufacture, construction, research and development activities for the execution of the contract ADP --- F4E --- QC REFERENCE DOCUMENTS [1] F4E-QA-010 Quality Classification Procedure (F4E_D_22MD99). [2] F4E-QA Naming Conventions Instruction (F4E_D_22GGJ4). [3] F4E-QA-115 Supplier Quality Requirements (F4E_D_22F8BJ) [4] F4E-QA-P-IO Quality Assurance program for items and services provided by the EU-DA to the ITER project. (F4E_D_22MCBA) [5] IAEA GS-R-3 IAEA Safety Requirements GS-R-3 (2006) The Management System for Facilities and Activities.

4 Page 4 / 11 Ver Introduction The Supplier shall develop and operate a management system that is appropriate to the works and is based on a recognized quality standard that meets F4E s Quality Assurance Program requirements, as defined by the IAEA Safety Requirements GS-R-3 and ISO 9001:2008, as applicable. This specification defines particular requirements of the management system to be implemented by the Supplier. These requirements are set out in the following sections: Section 1 Introduction this section defines the overall Quality Plan structure, its submission and acceptance. Section 2 Quality Plan this section defines the minimum requirements of the Supplier s Quality Plan, including the structure of the System Compliance and Implementation Plan parts. Section 3 Specific Requirements this section defines the contract specific/additional requirements/concessions of the Supplier s Quality Plan. Throughout the execution of the Works the Supplier shall comply with the Quality and General Requirements as defined in F4E-QA-115 Supplier Quality Requirements ([3] Section II) Supplier Quality Plan The Supplier shall produce a Quality Plan structured as an assembly of 2 separate parts: A System Compliance part that shall a) Comply with the requirements defined in the Quality System Compliance Part defined in F4E-QA-115 Supplier Quality Requirements ([3] Section III.1); b) Meet the specific requirements identified in this document (System Compliance part); c) Be specific to the nature of the Works to be executed. And a Implementation Plan part that shall a) Address the specific requirements identified in (Implementation Plan part) in compliance with the topics of the Quality Implementation Plan defined in F4E-QA-115 Supplier Quality Requirements ([3] Section III.2); b) Be specific to the Scope of Works under the Contract; c) Be the principal statement of the Supplier s intentions regarding execution of the Works on behalf of F4E Control Plan The Supplier shall produce and maintain a Control Plan listing the sequences of activities affecting quality as defined in F4E-QA-115 Supplier Quality Requirements ([3] Section IV - Control Plan Requirements).

5 Page 5 / 11 Ver Submission of Plans Quality Plan With Tender/Proposal Timing of submission Within 14 days of Contract Signature Within 14 days of receipt of F4E s comments Throughout contract Following Award of the Contract: Summary of Supplier Quality Plan Submissions Required submission Preliminary version Provisional version Final working version Update as necessary submit updates for F4E acceptance The Supplier shall produce and submit to F4E on or before the Kick-Off Meeting a provisional Quality Plan developed from his preliminary plan submitted with his tender, all in accordance with the requirements set out in this Annex. The Supplier shall not commence the performance of other duties, obligations and liabilities pursuant to the Contract until the provisional Quality Plan is approved by F4E in writing, with or without comments; Within 14 days of receiving approval and / or comments from F4E on the provisional Quality Plan, the Supplier shall submit his final Quality Plan; incorporating such comments as received from F4E; Throughout implementation of the Contract, the Supplier shall revise the final Quality Plan, or parts of them, as and when required, and shall submit such revisions to F4E for further approval Control Plan No activity shall be performed without that activity being covered by an F4E accepted Control Plan. The type of Control Plan covering the activity shall depend of the type of phase/task where the activity is integrated as defined in F4E-QA-115 Supplier Quality Requirements ([3] Section IV - Control Plan Requirements). The Supplier shall include in the Quality Plan the Top Level Control Plan for the works (the Top Level Control Plan is submitted with the Quality Plan). When required, the Supplier shall issue and maintain separate Control Plans detailing the phase/task works. These control plans shall be individually referenced documents, issued during implementation of the contract and shall be accepted by F4E before the concerned works start F4E s acceptance F4E s acceptance of Supplier s Plans shall not in any way limit the Supplier s duties and obligations pursuant to the Contract nor diminish any liability on its part in respect thereof.

6 Page 6 / 11 Ver Quality Plan ITER has been classified as an Installation Nucléaire de Base (INB), and within this larger class recognising the objective limit of the risks, in the subclass of Labs and Fuel Plants. Quality Assurance requirements are fulfilled by a system that complies with the requirements of the Order of August (French Republic Arrêté du 10 Août 1984 ) and in general uses as a basis the IAEA Safety Requirements GS-R-3 [5] and ISO 9001 as applicable. Quality implementation shall be determined according to the graded approach described in F4E-QA-010 Quality Classification Procedure, provided as part of the Reference Documents. This comprehensive approach covers a variety of systems, components, and activities. The Quality Level of the deliverables, as defined in the Quality Classification, is CLASS Scope The Quality Plan shall describe the quality system to be implemented by the Supplier throughout the progress of the Works to ensure that the contract requirements are met and that evidence of such compliance is maintained. The Quality Plan shall be an assembly of separate and well-identified documents that cover the whole scope of the Contract, including work performed by Subcontractors. The Quality Plan shall make particular reference to processes and management arrangements at the interfaces between consortium members, if applicable, and to interfaces with subcontractors Structure The Quality Plan shall encompass all activities performed by the Supplier and his subcontractors in connection with the Contract. The level of detail in the Quality Plan shall be consistent with: The technical requirements of the Contract; The Quality Classification of the deliverables; The quality and management requirements as specified in [3] (F4E-QA Suppliers Quality Requirements); The safety and operational importance of the items involved, as defined in 2 (Quality Plan); The involvement of activities that cannot be fully verified by an inspection or test; The degree to which compliance can be demonstrated by inspection or test; Design, performance or manufacturing margins and tolerances; The technical specification for Works required as set out in the Technical Specification, including level of monitoring and inspection required. The Supplier s methodology for generation of its master execution schedule(s) and execution plan(s); The Supplier s contract team organisation chart; The Supplier s Implementation Plan, as defined in

7 Page 7 / 11 Ver. 1.3 The Quality Plan shall be structured as set out below. QUALITY PLAN IDENTIFICATION 1. Document Reference Revision : 2. F4E Reference [contract / grant / call reference] 2.1 F4E TRO 3. F4E Customer Reference [PA / ITA / DWO reference] 4. SUPPLIER 5. Contract Title 6. Graded Quality level SYSTEM COMPLIANCE (address sections as defined in 2.3.1) Q1. Q2. [ ] IMPLEMENTATION PLAN (address sections as defined in 2.3.2) I1. I2.. [ ] 2.3. Contents of the Quality Plan Each part of the Quality Plan shall comply and address the topics defined in [3] (F4E-QA Supplier Quality Requirements ) The content of each part of the Quality Plan depends of the supplier s quality system certification and the Quality Classification (QC) of the deliverables. The supplier s quality management system (QMS) certification can be: Certified: Certified Quality Management System based on a recognized Quality Standard(s), or Suitable: suitable implemented and documented alternative management system. The level of detail of each section is defined in the following subsections. If a particular section is not applicable, the section shall nevertheless be identified and the reason for the non-applicability referenced.

8 Page 8 / 11 Ver. 1.3 Section System Compliance part SYSTEM COMPLIANCE (Sections to address in compliance with F4E-QA-115 III.1) Item Applicability QC2 / QMS Suitable QMS Certified Quality Plan describing the Supplier QMS for the contract Essential Processes in Formal Procedures and Instructions (either) In Informal Procedures (just flowcharts) Q0. Copy of the valid Quality Management System certification Quality Manual Reference A statement of compliance with the General Requirements (QA-115 II) -- Q1. Management of Scope Management of responsibility allocation -- Management of Nonconformity and Deviations Procedures -- Individual Flowchart per Process (deviation and nonconformity) Q2. Management of schedule Time Schedule Management through the use of PRIMAVERA (either) Simple Control system definition -- Time Schedule Evolution Report definition -- Q3. Management of Deliverables Formal Documentation Management System -- Flowchart of the Documentation flow Interaction with F4E Configuration Management records definition -- Control Plan update process -- Q4. Risk Management Risk Management process / description Q5. Resource management and training Resource management and training system description -- Q6. Subcontracting management Subcontracting management system description -- Q7. Assessment and validation management Assessment and validation management description -- Q8. Licensing Requirements Licensing Requirements assessment -- Q9. Incoming Parts Management Incoming Parts management description (incoming parts, material ) Q10. Design management Design management system description (inc. review, verification & -- validation) Design review & independent verification Q11. Other/Specific requirements (if specified in 3) Other/Specific requirements of the contract Formal/Fully Applicable Optional/Concession -- Not Applicable/Not Required

9 Page 9 / 11 Ver Implementation Plan part IMPLEMENTATION PLAN QC2 - Item Section (Sections to address in compliance with F4E-QA-115) Applicability I1. Objectives and Activities of the Contract Short description of the contract and objectives Table with Milestones / WBS / Deliverables / Documentation / Responsible Technical analysis of the SRA for SIC elements (SIC only) -- I2. Organisation and Responsibilities Detailed breakdown of responsibilities ( including organization flow chart) Technical Responsible + Quality Responsible Identification Identify the different organizations involved (including supply organisation chart) Stop Work Authority -- I3. Control Plan Top Level Control Plan with milestones/ key points/ reviews Phase Control Plan (depends on QA-115 IV) Extent of Inspection and Testing (for guidance): 100% Visual, Surface and Volumetric % Visual, 20% Surface and Volumetric 100% Visual, 10% Surface and Volumetric -- I4. Time Schedule Management Project Working Level Schedule (Execution Schedule) I5. Documentation Schedule Documentation Schedule (table/list) I6. Contract Resources Detail Resources per contract stages Evidences of Personnel Specific Training (including Qualification for Special Processes) I7. Subcontracting Schedule Subcontracting Schedule for Major/Critical items and activities I8. Execution Plan Execution Plan or Manufacturing plan Special Process Qualification & Control Analysis Codes usage and validation (agreement by F4E before work starts) I9. Risk Plan Contract Risk Risk Plan (either) Risk Card estimation (mandatory if no Risk Plan) I10. Project Controls EVM Reporting or alternative system implemented I11. Acceptance and Delivery Requirements Control of acceptance of deliveries I12. Inspection and Quality Audits Supplier s proposed audit schedule I13. Health and Safety Compliance Evidence If required by local authorities On Customer Site Operations - Customer Safety Regulations Health and Safety Plan (only for on IO site operations) I14. Codes (Regulatory Documents) and Standards Reference to Quality and Management applicable codes, standards and regulatory req. I15. Dual-Use items/technologies List of dual-use items/technologies I16. Identification and control of items Identification and control of items system (traceability requirements)

10 Page 10 / 11 Ver. 1.3 IMPLEMENTATION PLAN Section (Sections to address in compliance with F4E-QA-115) Define how traceability requirements are identified and incorporated into documents I17. Handling, storage, packing, shipping and delivery Control of handling, storage, packing, shipping and delivery I18. Statistical techniques Statistical techniques description I19. Other/Specific (if specified in 3) Contract Specific requirements Formal/Fully Applicable Optional/Concession -- Not Applicable/Not Required QC2 - Item Applicability 2.5. Quality Plan Update and Validation The Supplier shall update the Quality Plan to final working status after it has received the accepted provisional Quality Plan from F4E, with or without comments. The Supplier shall not implement updates to the Quality Plan until the Quality Plan has been accepted by F4E in writing. Throughout the duration of the Contract, the Supplier shall revise as necessary and maintain the Quality Plan up to date. No update of the Quality Plan shall be implemented by the Supplier until it has been accepted by F4E in writing, whereupon the accepted, updated version shall become the Quality Plan. The Quality Plan is an integral part of the Contract. The Quality Plan, and a record of any amendments made thereto during the continuance of the Contract, shall be included in the Final Report provided to F4E upon completion of the Works. 3. Specific Requirements (Additions / concessions to QA-115) The supplier conducting the activities described in the Annex B Technical Specification shall have an ITER approved Quality Assurance program or an ISO 9001 accredited quality system. Project Meetings: A kick-off meeting shall take place after the contract signature, see the details in [3]. Progress meetings shall take place bi-monthly after the T 0 of the contract (T 0 is the time when F4E delivers the material for the beneficiary). A final meeting shall take place in the end of the contract System Compliance Documentation review cycle: F4E will have twenty (20) working days from the receipt of Supplier s Documents (with the exception of the Quality Plan) to review, comment on and/or, as the case may be, approve them; The Supplier shall have fifteen (15) working days from the receipt of commented documents to update and resubmit them to F4E via ; and

11 Page 11 / 11 Ver. 1.3 F4E will have fifteen (15) working days from the receipt of the Supplier s to review and return the documents. Electronic Documents: Document Type Editable Reference Informative Format Version Format Format CAD models and drawings Cat CATIA v.5 or cat pdf of typical 3-D views CAD drawings Cat AutoCAD where applicable pdf Implementation Plan None