Codes & Standards and Quality Assurance

1. Codes & StandardsandQuality Assurance M. Ferrari EFDA Close Support Unit Barcelona ELE Preparation Project IL PROGETTO ITER Giornata di Presentazione del Progetto ITER all’Industria Italiana Frascati, 19 gennaio 2007 – Villa Tuscolana Marco Ferrari – Codici, Standards & QA – Frascati, 19 gennaio 2007

2. Outline • Rules & Regulations in France for safety and licensing • Codes & Standards for nuclear safety • Pressure Equipment • Buildings • Quality Assurance Marco Ferrari – Codici, Standards & QA – Frascati, 19 gennaio 2007

3. ITER Organization Project Typology • International collaboration with “in-kind” procurement • “First-of-a-kind” device/plant Marco Ferrari – Codici, Standards & QA – Frascati, 19 gennaio 2007

4. Actors & Responsibilities • ITER-org (owner, operator)  The User • Is the responsible for safety • Ensures quality • May appoint directly qualified & skilled staff • Observes national laws in the fields of public and occupational health & safety, nuclear safety, radiation protection, environmental protection,… • Domestic Agencies (suppliers) • Procure “in-kind” components & systems according to the ITER-org technical and quality requirements • In same case perform design activity based on ITER-org functional and performance requirements Marco Ferrari – Codici, Standards & QA – Frascati, 19 gennaio 2007

5. Regulation System in France Licensing, QA Laws Decrees Orders Ministerial Letters Basic Safety Rules Radioprotection Environmental requirements Pressure Vessel Issued by Safety Authorities Issued by Industry or NPP-Operators and approved by Safety Authorities Design and Construction Rules Internal Rules and Specifications of Industry and NPP-Operators RCC, IEC, ISO/NF standards, ASME, ASTM, handling, electricity,… Marco Ferrari – Codici, Standards & QA – Frascati, 19 gennaio 2007

6. C&S perITER What is the logic? • Design and safety requirements • Regulations (IAEA/ICPR  EU  France) • Essential Safety Requirements (ESRs) • Available calculation codes, codes and standards • ITER, according to the procurement sharing and other inputs, will specify what should be followed to fulfill essential safety requirements; this will usually be a unique set of C&S for one component. • Field Teams in contact with Domestic Agencies will insure that the final set used by end-supplier complies with ITER specification Marco Ferrari – Codici, Standards & QA – Frascati, 19 gennaio 2007

7. French Rules & Regulations on PE ESPN Marco Ferrari – Codici, Standards & QA – Frascati, 19 gennaio 2007

8. ESRs for Pressure Equipment • General obligations for manufacturer • e.g. to carry out hazard analysis incl. reasonably foreseeable misuse • to establish technical documentation file • Design and calculation • Design for adequate strength • Take into account sources of hazard, e.g., handling and operation, examination, draining and venting, corrosion, chemical attack, wear, filling and discharge, exceeding allowable limits, safety accessories, external fire • Manufacturing • Manufacturing procedures, e.g., preparation of components, permanent joining, heat treatment, traceability • Final assessment, e.g., final inspection incl. safety devices, proof test • Marking and labelling • Operating instructions • Materials • Specific requirements • for fired or otherwise heated pressure equipment • for piping • Specific quantitative requirements (general rule) Marco Ferrari – Codici, Standards & QA – Frascati, 19 gennaio 2007

9. Pressure hazard ESPN level N1 Cat. IV Cat. III ------ PED ------ Cat. II ESPN level N3 ESPN level N2 Cat. I Cat. 0 0,5 bar -------- no pressure equipment requirement ---------- 370 MBq 370 GBq Nuclear hazard Pressure Equipment Marco Ferrari – Codici, Standards & QA – Frascati, 19 gennaio 2007

10. C&S for ITER • Licensing and site specific requirements: • French regulations and conformity to national laws and EU directives • Nuclear or non-nuclear? (nuclear codes developed for fission reactors) • Experimental nature of the device (or of some components) • Technical specific feature of the components (not addressed by existing codes): • Basic geometry of components (toroidal geometry, double shell structure, several geometrical discontinuities, etc.) • Non-standard manufacturing, inspection and testing processes • Special materials • Specific design loads (type of design loads, experimental nature of the machine, etc.) Marco Ferrari – Codici, Standards & QA – Frascati, 19 gennaio 2007

11. C&S Activities • On going activities: • Adaptation of codes to site specific requirement (national laws) • Modification/addition to RCC-MR for ITER VV metallic parts • Technical specifications for ITER VV non-metallic parts • Selection of building code • Implications of using ASME for components installed in Europe • Review of the Structural Design Criteria (SDC) for ITER Magnets • Short–medium term activities: • Further development of design criteria for In-vessel Components (SDC-IC) • Selection of standard for manufacturing of in-vessel components • Revision of the code selection for ITER components based on procurement sharing • Verify compatibility between different codes Marco Ferrari – Codici, Standards & QA – Frascati, 19 gennaio 2007

12. ASME & Others • ASME or other codes could not be recognized directly as conforming to all requirements of European regulations, i.e., as directly satisfying the Essential Safety Requirements (ESRs) • Use of ASME or other codes is possible, provided that: • sufficient evidence is given (by the Manufacturer) of conformance to ESRs, • conformance to ESRs is assessed by a Notified Body, • procedures & personnel for welding and for NDT are approved according to the European regulations This means that use of ASME or other codes cannot only be dealt with by some additional conformity assessment, involving only a Notified Body. The manufacturer has also to perform some additional tasks, like for instance welding qualifications according to European rules. Marco Ferrari – Codici, Standards & QA – Frascati, 19 gennaio 2007

13. Code Selection • General strategy for components code selection: • Minimize number of Codes • 1 Code for 1 component (or system) • Minimize number of interfaces where different codes are used • Vacuum Vessel: the EUPT (EFDA) has proposed RCC-MR with a specific new addendum • The Addendum includes some modifications to adapt the code to the ITER special features and shall be finalised shortly in accordance with French rules (PED-based & ESPN) • The Conformity to PED and ESPN is in progress in France: • RCC-M modification to conform PED and ESPN during 2007 • RCC-MR afterward (date not defined) Marco Ferrari – Codici, Standards & QA – Frascati, 19 gennaio 2007

14. DRAFT - Courtesy by ITER Classification of ITER Components Marco Ferrari – Codici, Standards & QA – Frascati, 19 gennaio 2007

15. C&S for Buildings (1) The ITER nuclear complex shall be designed and fabricated according to ITC-C (ITER Technical Code for Civil Works) fully compliant with Eurocodes Marco Ferrari – Codici, Standards & QA – Frascati, 19 gennaio 2007

16. C&S for Buildings (2) • ITC-C derived from ETC-C, the Technical Code for European Pressurized Reactor (EPR) Civil Works • ETC-C constitutes the code used as base for the design and for the fabrication of the safety classified civil-engineering works for EPR • The design rules for civil engineering structures in ETC-C and ITC-C are based on Eurocodes approach & philosophy • ETC-C and ITC-C may be considered as practice guidelines on how apply Eurocodes for specific projects (EPR and ITER respectively) Marco Ferrari – Codici, Standards & QA – Frascati, 19 gennaio 2007

17. Eurocodes Marco Ferrari – Codici, Standards & QA – Frascati, 19 gennaio 2007

18. Quality Assurance • EFDA, as one of the main contributors to ITER design and R&D activities, has started the development of a QA System compatible with licensing requirements in France • The structure of this QA system is considered as a basis for the QA System for the EU-DA • As one of the ITER organization main suppliers, the EU-DA will implement a Quality Management System which main objective is to ensure ITER that the delivered items fulfill the ITER requirements in the agreed time, by: • Controlling the EU-DA internal activities • Controlling the EU suppliers activities Marco Ferrari – Codici, Standards & QA – Frascati, 19 gennaio 2007

19. QA Regulatory/Legal Requirements • The reference for QA, for Safety Important Components (SIC), is given by French law, with the Order of August 10, 1984 concerning ‘Basic Nuclear Installation design, construction and operation quality’ , and the associated explicatory note that gives more extensive explanation on its application • The legal requirements are fulfilled by a QA system that complies with the rules of IAEA Series 50-C-Q, and the instructions contained in the related Safety Guides, 50-SG-Q1 to Q14 • IAEA Series 50-CQ is largely equivalent to ISO 9001:2000 with a limited number of deviations and integrations explained in the IAEA publicationSafety Report- Series No.22 Quality Standards: Comparison between IAEA50-C/SG-Q and ISO9001:2000’ Marco Ferrari – Codici, Standards & QA – Frascati, 19 gennaio 2007

20. Quality Manual Organization Responsibilities Documentation & info management Non-conf. management Resources management Procurement management Audit & int. control Config. management EFDA QA System – Generalities • A QA documentation for EFDA for ITER related activities (not approved for implementation) is available. • Set of quality documents based on IAEA Safety series 50-C/SG-Q and compatible/complemented with ISO 9001 (2000). • The general structure has been presented to ITER and other Parties (QA Meeting March 2006) • All the QA is written on the assumption that Procurement management for ITER is the main EFDA (and ELE) process implemented (no internal design activity is foreseen) Marco Ferrari – Codici, Standards & QA – Frascati, 19 gennaio 2007

21. EFDA QA System for Procurement • The control of the activities of EFDA suppliers (including Associations) is made through three contractual documents dedicated and tailored for each contract placed by EFDA to European industry or laboratories. • The technical specification defines the object of the contract (the « as specified » configuration of the product) • The management specification defines the quality requirements to be met by the supplier. • The contractdefines the commercial and legal requirements and provisions that are applicable • These documents are issued by EFDA, reviewed and approved by ITER. They are tailored according to ITER requirements including quality classification • To achieve these requirements, the Supplier shall provide a dedicated Quality Plan describing the quality provisions it will implement to perform the work Marco Ferrari – Codici, Standards & QA – Frascati, 19 gennaio 2007

22. Technical Specification • Scope of the supply • Items supplied by ITER • Technical requirements • Functional requirements • Interfaces requirements • Safety and regulation requirements • Environmental requirements • Physical requirements • Operational requirements • Human factor requirements • Integrated logistic support requirements • Product assurance requirements • Configuration requirements • Codes and standards • Verification and approval requirements • Documentation requirements • Identification requirements • This document collects all the design input data. It specifies completely and unambiguously the product to design and the details to achieve (preliminary or detailed design). The technical specification details the quality requirements of the product’s design and defines precisely the deliverables and their associated documentation. • For the supplier of the design activities, these inputs are assumed to be fully completed and approved. Marco Ferrari – Codici, Standards & QA – Frascati, 19 gennaio 2007

23. Management Specification • Introduction • Subject • Reference and applicable documents • Management requirements • Responsibilities requirements • The bidder shall identify the different organizations involved to perform the contract and detail the breakdown of responsibilities. • Project management • Frequency and location of the progress meetings • Content and frequency of the progress report • Work plan • Sequences of the work, milestones, key points, reviews, • Work Breakdown Structure (WBS) • Resources requirements • Specific training for personnel • Specific qualification for particular operations • Non-conformance requirements • Transfer to EFDA non-conformance report before any actions for all major non-conformances • Communicate to EFDA the list of all the non-conformances and the associated actions on a regular basis • Change and configuration requirements • Ensure changes are approved by EFDA before any implementation. • Time schedule requirements • Information and documentation requirements • Language to use • List of the documents and records to be issued and controlled • Risk management • Preliminary risk analysis • Procurement requirements • Evidence of effectiveness of the subcontractor quality system • EFDA approval of the proposed suppliers or subcontractors • Assessment and validation requirements • Signature and dating of progress reports for each completed operation • Issue and up-dating of a conformity matrix • Acceptance and delivery requirements • Review of the documentation (Acceptance Data Package) to be provided • Provide a formal Contractor Release Note This document outlines all the quality requirements of the design process management. The purpose is to ensure that all personnel involved in the procurement process use the same management rules and to allow the EFDA Work Package Manager to monitor properly the contract. Marco Ferrari – Codici, Standards & QA – Frascati, 19 gennaio 2007

24. The Quality Plan as a tool for QA implementation • The Supplier shall be requested to provide a Quality Plan indicating how the requirements set in the Management specification are actually fulfilled • At the tender level, the bidder shall provide a meaningful summary of the overall content of the final Quality Plan. This Quality Plan is one criterion of the bid assessment. In response to the management specification, it describes the quality disposals that the bidder will implement for the work. • The content of the Quality Plan depends on the nature and criticality of the work (including quality classification). • Guidance notes will be sent to the bidders in order to help them to issue their Quality Plan according to the work to be performed: • Quality management in Design contracts • Quality management in R&D contracts • Quality management in Manufacture contracts • Quality management in Integration contracts • Quality management in Test and Acceptance contracts • Quality management in Construction contracts • The compliance with the Quality Plan shall replace certifications and shall be limited to the actual part (division, department, workshop, laboratory) of the Industry that is performing the work. Marco Ferrari – Codici, Standards & QA – Frascati, 19 gennaio 2007

25. Conclusion on QA • No specific problem appears in the implementation of QA procedures compatible with lTER actual requirements but • The ITER QA documentation shall be progressively complemented with a series of internal standards and codes of practice reviewing and integrating documents like • CAD Manual • Vacuum Handbook • Remote Handling Manual • Radiation Hardness Manual • Etc.. Marco Ferrari – Codici, Standards & QA – Frascati, 19 gennaio 2007