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Quality control of equipment manufacturing for nuclear facilities

Yury Rabinovich. Quality control of equipment manufacturing for nuclear facilities. CONFORMITY ASSESSMENT. DEFINITION

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Quality control of equipment manufacturing for nuclear facilities

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  1. Yury Rabinovich Quality control of equipment manufacturing for nuclear facilities

  2. CONFORMITY ASSESSMENT • DEFINITION • Federal LawNo. 184-FZOn Technical Regulationdefinesconformity assessment as direct or indirect determination ofthe product’s compliance with the requirements set for it. • REGULATORY REQUIREMENTS • All equipment, components and technologies for nuclear facilities, radiation sources and storage sites are subject to conformity assessmentin accordance with Russian legislation (170-FZ, article 37) • Russian Federation Government Decree datedJuly 20, 2013 No. 612On Accreditation in the Field of Atomic Energy Use • Russian Federation Government Decree dated March 1, 2013 No. 173 Concerning Approval of Regulation on Special Aspects of Standardization of Products (Works, Services) Subject to Requirements Connected with Ensuring Safety in the Field of Atomic Energy Use • Conformity assessment should be exercised pursuant to enacted Decree datedJuly 1, 2007 No.NP-071-06 Rules of Conformity Assessment of Equipment, Components, Materials, and Semi-processed Materials, Supplied to Nuclear Facilities. These rules are obligatory to comply with while manufacturing and supplying equipment to nuclear facilities. • Acceptance (supervision over the quality of equipment designing and manufacturing) is performed in accordance with requirements set in international contracts on constructing nuclear facilities abroad as per Russian projectsor IAEA requirements(i.e. 50-C/SG–Q4).

  3. CONTROL AND CONFORMITY ASSESSMENT TOOLS • Standardization • Metrological support • Personnel qualification management and employee engagement • Document support • Quality control • Conformity assessment • Statistical management methods • Decision-making methods

  4. LEVELS OF RESPONSIBILITY FOR THE QUALITY OF EQUIPMENT FOR NPPs

  5. RESPONSBILITY FOR USING EQUIPMENT, COMPONENTS, MATERIALS AND SEMI-PROCESSED MATERIALS AT NUCLEAR FACILITIES • Pursuant to the legislation operating organizations bear the responsibility for using at nuclear facilities equipment, components, materials and semi-processed materials assessed for conformity and compliant with requirements of Federal standards and rules in the field of nuclear energy use • Assigned operating organizations are: • mining and chemical plantsprocessing nuclear materials • enterprises performing researches involving the use of nuclear materials • organizations possessing research reactors, critical and subcritical experimental facilities,andusing radiation sourcesand radioactive materials • shipping companies operating nuclear-powered vessels • Radon specialized plants (collecting, transporting, processing, storing and burial of low and intermediate level radioactive wastes) • health care and otherinstitutions using radiation sources and radioactive materials • Conformity assessment is performed in accordance with Decree No. NP-071-06 enactedon July 1, 2007 Rules of Conformity Assessment of Equipment, Components, Materials, and Semi-processed Materials, Supplied to Nuclear Facilities.These rules are obligatory to comply with while manufacturing and supplying equipment to nuclear facilities.

  6. QUALITY CONTROL MECHANISMS

  7. CONFORMITY ASSESSMENT IN THE FORM OF ACCEPTANCE IN THE FORM OF TESTS IN THE FORM OF STATE SUPERVISION IN THE FORM OF OBLIGATORY CERTIFICATION • PERFORMED BY FEDERAL SERVICE FOR ENVIRONMENTAL, TECHNOLOGICAL AND NUCLEAR SUPERVISION • PERFORMED BY PRODUCT MANUFACTURERAND OPERATING ORGANIZATION (OR ORGANIZATION ACTING UNDER ITS AUTHORITY) • PERFORMED BY PRODUCT DESDIGNER OR MANUFACTURER • PERFORMED BY A CERTIFICATION BODY • Acceptance commission with participation of client (customer) designer, manufacturer, (optionally) expert organizations, andFederal service for Environmental, Technological and Nuclear Supervision • CARRYING OUT INSPECTIONS FOR CONFIRMATIONOF ACTION CONDITIONSOF LICENSESFOR THE RIGHT TOMANUFUCTURE WITHIN THE CONTEXT OF SUPERVISION OVER OBSERVANCE OF FEDERAL STANDARDS AND RULES IN THE FIELD OF ATOMIC ENERGY USE • CARRYING OUT INSPECTIONS FOR CONFIRMATION OF FULFILLING SPECIFIC SUPPLY CONTRACT REQUIREMENTS (INCLUDINGPERFORMING OTHER TYPES OF CONFORMITY ASSESSMENT) AND INDEPENDENT OF MANUFACTURERINSPECTIONS OF QUALITY ASSURANCE PLANS (ADDITIONAL PRODUCTS QUALITY CONTROL) CARRYING OUT ACCEPTANCE, QUALIFICATION AND COMISSIONING TESTS FOR CONFIRMATION OF PRODUCTS COMPLIANCE WITH REQUIREMENTS OF DESIGN AND DETAIL DESIGN DOCUMENTATION • CARRYING OUT INSPECTIONS AND INDEPENDENT TESTS FOR CONFIRMATION OF EQUIPMENT, PRODUCT AND PROCESS CERTIFICATION SYSTEM REQUIREMENTS • SUBJECT TO NP-071-06, JOINT DECISION OF ROSATOM AND FEDERAL SERVICE FOR ENVIRONMENTAL, TECHNOLOGICAL AND NUCLEAR SUPERVISION No. 06-4421, JSC “ENERGOATOM CONCERN”REGULATORY DOCUMENTS AND METHODOLOGY GUIDELINES • SUBJECT TOREGULATION ONFEDERAL SERVICE FOR ENVIRONMENTAL, TECHNOLOGICAL AND NUCLEAR SUPERVISION, NP-071-06, OTHER FEDERAL STANDARDS AND RULESIN THE FIELD OF ATOMIC ENERGY USE, AND FEDERAL SERVICE FOR ENVIRONMENTAL, TECHNOLOGICAL AND NUCLEAR SUPERVISION REGULATORY DOCUMENTS • SUBJECT TO NP-071-06, JOINT DECISION OF ROSATOM AND FEDERAL SERVICE FOR ENVIRONMENTAL, TECHNOLOGICAL AND NUCLEAR SUPERVISION No. 06-4421, STATE STANDARDS ON THE SYSTEM OF PRODUCTS DESIGNING AND LAUNCHING INTO MANUFACTURE • SUBJECT TONP-071-06, EQUIPMENT, PRODUCT AND PROCESS CERTIFICATION SYSTEM DOCUMENTS PRODUCTS

  8. FORMS OF CONFORMITYASSESSMENT • NP-071-06 Rules of Conformity Assessment of Equipment, Components, Materials, and Semi-processed Materials, Supplied to Nuclear Facilities determines the following forms of conformity assessment: • Conformity assessment in the form of tests • Conformity assessment in the form of state control (supervision) • Conformity assessment in the form of acceptance • Conformity assessment in the form of confirmation of conformity (certification)

  9. FORMS OF CONFORMITY ASSESSMENT • STATE CONTROL (SUPERVISION) • Object:Obligatory for all safety important equipment (safety classes 1, 2, and 3) • Mechanism:Licensingand supervision over licenses action conditions – checking observance of standards and rules in the field of atomic energy use. • TESTS • Object:Obligatory for all equipment manufactured for the first time, or upgraded/modified equipment and for equipment with a pause in manufacture of more than 3 years (safety classes 1, 2, 3, and 4). • Mechanism:- tests planning and testing products samples; • - participating in acceptance, qualification and commissioning tests carried out by representatives of customer, designer, manufacturer, and supervisory authority; • - approving tests results by the operating organization • ACCEPTANCE • Object:Obligatoryfor all safety important equipment (safety classes 1, 2, and 3), and materials, semi-processed materials and components for equipment of safety classes 1 and 2. • Mechanism:Quality control (in addition to the control exercised by the factory QC department) of engineering and manufacturing, and inspection operations according to QAPsbased on manufacturing procedures. • CONFIRMATION OF CONFORMITY (CERTIFICATION) • Object: Equipment subject to obligatory certification as per the equipment, product and process certification system, approved by Ministry of atomic energy, Federal Agency on Technical Regulating and Methodology, and Federal inspectorate for nuclear and radiation safety authority • Mechanism:- regulatory requirements review (certification basis); • - products samples testing in certified laboratories under supervision of certification bodies; • - approval of tests carried out earlier.

  10. Organizations carrying out conformity assessment Federal service for Environmental, Technological and Nuclear Supervision Interagency commissions consisting of representatives of the Client, General Designer, Chief Designer, Manufacturer and a supervision body Plant laboratories, test centers Conformity assessment in the form of state supervision PRODUCTS Obligatory certification Specialized expert inspectorate organizations Equipment, product and process certification system bodies Documents review Acceptance Participation in tests Procedures are not conducted to the full extent, not for all products There is no industry-specific regulation for the procedures, procedures are not conducted for all products

  11. Mechanisms of conformity assessment In the form of state supervision realized by a regulating body (Federal service for Environmental, Technological and Nuclear Supervision): Issuing licenses for designing and manufacturing of products for NPPs and for related services (specialpersonnel competence assessment, quality assurance programs assessment, etc.) Elaboration of rules and standardsin the field of atomic energy use Supervision over fulfillment of license action conditions and observance of standards and rules Expert evaluation of the report on safety case of using equipment at NPPs

  12. Conformity assessment In the form of acceptance Now conducted by JSC ZarubezhatomenergostroyandVO Safety in accordance with: Decision ofFederal Atomic Energy Agency andFederal Service for Environmental, Technological and Nuclear Supervision dated June 25, 2007 No. 06-4421 On the Procedure and Scope of Conformity Assessment of Equipment, Components, Materials, and Semi-processed Materials, Supplied to Nuclear Facilities NP-071-06 Rules of Conformity Assessment of Equipment, Components, Materials, and Semi-processed Materials, Supplied to Nuclear Facilities Managing and methodology documents of Concern Rosenergoatom Contracts with the operating organization

  13. Conformity assessment In the form of tests • Conducted by a commission with representatives of the designer, manufacturer, client and its designated organization participating in the form of tests in accordance with • GOSTR 15.201-2000 • System of product development and launching into manufacture. Procedure of product development and launching into manufacture

  14. General algorithm of conformity assessment in theform of acceptance during the manufacture Participation of the Client The level of participation of the Client is defined in the course of negotiations between the Parties. Choice of authorized organization Review report Review of design and process documentation Acceptance planning Quality plan Control plan Readiness for manufacture inspection certificate Checking the status of preparation for the launching of manufacture Acceptance notification Notes in Quality Plans Report on nonconformities Work completion report Conducting checks and inspections in the Quality Plans inspection points Feedback Acceptance report Signing the Quality Plan Acceptance inspections Database Reports on quality analysis Data analysis Quality expenses control Imposing penalties

  15. Products designing and launching into manufacture • According toGOST R 15.201-2000Procedure of Product Development and Launching into Manufactureconsists of the following stages: • elaboration of terms of reference • elaboration of technical and regulatory documents • products samples manufacturing and testing • acceptance of the development results • preparation and mastering the manufacture Atomic industry-specific aspectsof products designing and launching into manufacture: • test samples • scope of testing • participation of supervisory bodies representatives’ in the commission • development and approval procedures (General Designer, Chief Designer of the reactor unit, Chief Designer of the equipment, etc.)

  16. types of testing and tested items

  17. Certification schemes • Scheme1envisagesproducts samples testing forcompliance with regulatory documents in a certified research center (laboratory) • Scheme2is an addition to scheme 1 (after issuing the certificate) –follow-up inspection control via testing a product sample from the market • Scheme 2ais an addition to scheme 2 — analysis of the status of manufacturing of certified products using methods elaborated by the certification body • Scheme 3 involves an addition to scheme 1 (after issuing the certificate for the product) – follow-up via inspection testingof samples taken from the manufacturer’s finished products warehouse before sending them to the customer • Scheme 3aenvisages an additionto scheme 3 (beforeissuing the certificate for the product) – analysis of the status of manufacturing of productsbeing certified using methods elaborated by the certification body • Scheme 4 is based on testing products samples (see schemes 1- 3) via the follow-up inspection testing of samples both from the market and from the finished products warehouse • Scheme 4ainvolves an addition to scheme 4 (beforeissuing the certificate) – analysis of the status of manufacturing of productsbeing certified using methods elaborated by the certification body • Scheme5 is based ontesting products and certification of manufacture or quality system with a follow-upinspection, manufacture conditions stability control, and quality system functioning • Scheme6 involves testing the producer quality system certification on the basis of a special document • Scheme7 specifies testing a sample, selected from a batch of produce • Scheme8 is based on testing every single item for compliance with requirements of regulatory and other documents

  18. Product quality verification at a manufacturing facility is exercised on the following stages Control of design and process documentation Launching products into manufacture Incoming inspection of components, materials and semi-processed materials Control of manufacturing technology procedures on all lifecycle stages Product testing Final products inspection before shipping Control of logistics operations

  19. Operating organization documents regulating conformity assessment • RD EO 1.1.2.01.0713 Regulation on Quality Control of Manufacturing of Equipment for Nuclear Power Plants • Methodology GuidelinesArrangementof Quality Control of Manufacturing of Equipment for Nuclear Power Plants • Methodology Guidelines Managing Nonconformities while Manufacturing of Equipment for Nuclear Power Plants Cooperation of organizations participating in carrying out conformity assessment must be exercised in compliance with requirements of Liason protocol of JSC Concern Rosenergoatomand the General Contractor for arranging and carrying out conformity assessment while manufacturing the equipment for nuclear power plants

  20. Issues related with Conformity assessment in the form of acceptance • Until the present time inspection over designing and manufacturing, and acceptance inspectionsof equipment atdesign and engineering enterprises and manufacturing plantswere carried out byFederal Service for Environmental, Technological and Nuclear Supervision • After its functions changed (Law on technical regulation),Federal Service for Environmental, Technological and Nuclear Supervisiondeals only with regulation via control over action conditions of licenses being issued • The necessity of independentinspectionover the compliance with standards and rules on safetywhile designing and manufacturing the equipmentis defined by both clients’ (operating organizations, supplier enterprises, etc.) requirementsand the IAEA international requirements • There are no efficient mechanisms of correcting conformity assessmentprocedures in casenonconformities or defects are detected while checking formally compliant equipment (manufactured at enterpriseswhich were assessed for conformity and have a certified Quality Management System)

  21. Industry status • Negative factors: • long-term lack of orders • unstable financing • change of structure and/orowners • suspension of manufacture, obsolence of equipment • loss of personnel • decline in manufacturing culture • loss of communication with suppliers ofmaterials, semi-processed materialsand components • large volume oflow quality importeditems • Positive factors: • nuclear Renaissance • NPPs construction abroad assuring compliance withinternational requirements • direct contracts of enterprises and organizations with foreign customers

  22. Regulatory requirements • Main aspects of competitive ability: • Confirmed knowledge of international standards • Products compliance with international standardsrequirements • Personnel compliance with international standards requirements • Manufacture and businesscompliance with requirements • Independent (of the ordering customer) conformity confirmation • Difficulties: • Insufficientlegislative framework on responsibility for quality in the field of atomic energy use • Complicated and not exactly objectivesystem of licensing in the field of nuclear energy use • Insufficientelaboration of the standardization system (specifically the standards) • Poor cooperation with international standards organizations within the industry (IEC, IEEE, ISO, ASME, ASTM, IAEA, NEA OECD) • The necessity of investing significant resources in the process of transferring to international standards

  23. Analysis of experience in quality Supervision procedures • Main aspects • Continuity between projects (lessons learned); • A round table is necessary when discussing problematic issues; • Status of decision-making (who canpoint out the necessity of requirements); • Time pressure; • Approval ofdesign documentation by the start of manufacture; • Obligatory carrying out of the procedure of launching into manufacture, test samples, tests (absence of tests results in insufficientqualification)as a consequenceof absence of the public sector customer system; • Carrying out independent examination of requirements for compliance of equipment with rules and standards; • There is no single industry-wide systemof training for control, expert, and inspection personnel. • Issues connected with conformity assessments and safety inspections • Quality control, conformity assessment and supervision over quality and safety on the site must be carried out by applying the same rules; • Reinforcement of works on supervision over project activities; • Obligatory evaluation and certification system for expert and inspection enterprises and organizations; • Providing full set of conformity assessment documents (technical requirements, terms of contract, supply, installation); • Elaboration of a unifiednonconformityand technical decisions management system. Classification

  24. proposals • Experience in quality control and conformity assessment suggestsgood prospectsfor nuclear industry on both Russian and foreign markets. • It is necessary to better coordinate work on standardization, metrology and conformity assessment. • Setting standards on the level of the industry or the corporation is required • There is a need to migrate to international standards in the field of nuclear energy use • Target financing of such a migrationis necessary • It is necessary to focus on analytical work and to implement information technologies within the whole equipment lifecycle • There is a need for a permanently active round table for resolving issues and taking corrective and preventive measures • It is essential to take immediate steps to unify, standardize, and conduct methodically considered conformity assessment of equipment, components, materials and semi-processed materials for NPPs • It is important tounify systems of control, expert and inspection personnel training and qualification, and also to unify methods of quality control and conformity assessment procedures monitoring at the industrial level

  25. “optimization of conformity assessment of equipment for nppS” ProjectIn 2013 as part of the project the following industry regulatory documents wereelaborated and issued: • Temporary procedure of inspection of the enterprise's readiness for manufacturing of equipment for Rosatom State Corporation NPPs introduced by Order № 1/803-PdatedJuly 31, 2013 • Project - Optimization of examination of the milestoneEnterprise's readiness for manufacturing at Atomenergomash enterprisesFeb–Jun, 2013 • Temporary procedure of acceptance inspections in organizations manufacturing of equipment of safety classes 1, 2, and 3 introduced byOrder № 1/1036-P datedSeptember 27, 2013 • Project - Optimization of examination of the milestoneAcceptance inspection at Atomenergomash enterprisesFeb–Jun, 2013 • Temporary procedure of receipt control of equipment of safety classes 1, 2, and 3 at a nuclear power unit site introduced by Order 1/1436-PdatedDecember 26, 13 • Project- Reducing time of equipment receipt control at a NPP site Feb–Dec 2013 • Temporary instructions on drawing up passports for a nuclear power unit vessel,a nuclear power unit pump, a nuclear power unit pipeline, pipeline fittings for NPP, and manufacturing certificatesfor pipe and assembly units for a nuclear power unit pipelineintroduced by Rosatom State Corporation Order №1/1311-Pdated November 29, 2013 • Project- Reducing time of elaboration and approving operating documentation: Passport of a nuclear power unit vessel, Passport of a nuclear power unit pump, Manufacturing certificatesfor pipe and assembly units for a nuclear power unit pipeline, Passport of a nuclear power unit pipeline Jul–Nov, 2013 • Industry documentRegulation on industrial material organization enacted by Order № 1/1255-Pdated November 21, 2013 • Project- Reducing time of approving decisions on applying materials, components, etc. Jul–Dec, 2013

  26. Project “optimization of conformity assessment of equipment for nppS”In 2014 as part of the project the following industry regulatory documents wereelaborated and issued: • Standard contents of the Quality Plan of pumping equipment, parts and assembly units, valves, etc. • Project- Optimization of elaboration and approving Quality Plan of Pumping equipment, Parts and assembly units, and valves • Regulation on approving decisions on using imported equipment, products, materials and components at NPPs in Rosenergoatom Concern • Project - Reducing time of approving decisions on using materials, components, etc. • Regulation on designated organization on conformity assessment of equipment, products, components, materials and semi-processed materials supplied to nuclear facilities in the form of acceptance and tests • Elaboration of the model of conformity assessment of equipment for NPPs

  27. Projects initiated in2014 Standardization of procedures of conformity assessment of materials, components and equipment imported in the Russian Federation Creating an industrialdata bases of material organizations expert evaluations Improving activities of designated organizations on equipment conformity assessment Creating system of conformity assessment of construction and installation works at facilities of safety classes 1, 2, and 3 Optimization of conformity assessment of commissioning works at facilities of safety classes 1, 2, and 3 Setting standard requirements forQuality Assurance Programs of manufacturers of products for NPPs Elaboration of standard contents of Quality Plans for blanks (forgings) Setting quality indicators of manufacturers (industry-related suppliers) Optimization of incoming inspection of components and semi-processed materials used when manufacturing equipment of safety classes 1, 2, and 3 Proceeding with activities on implementing “Optimization of Conformity Assessment of Equipment for NPPs” project

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