1. Quality control of equipment manufacturing for nuclear facilities
Yury Rabinovich
September 2017

2. CONFORMITY ASSESSMENT
DEFINITION
Federal Law No. 184-FZ On Technical Regulation defines conformity assessment as direct or indirect determination of the 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 assessment in accordance with Russian legislation (170-FZ, article 37)
Russian Federation Government Decree dated July 20, 2013 No. 612 On 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 dated July 1, 2007 No. NP 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 projects or 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
Ensuring compliance with international standards and rules in case of exporting Russian NPP Projects
Federal Service for Environmental, Technological, and Nuclear Supervision - in the form of licensing and supervision
Rosatom State Corporation as a managing body of the industry sector
Managing companies (corporations) like Atomenergoprom in a vertical range of integration
Operating companies (Federal Law On the Use of Atomic Energy, article 35)
Enterprises: Designers, Manufacturers (Federal Law On the Use of Atomic Energy, article 37)

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 plants processing nuclear materials
enterprises performing researches involving the use of nuclear materials
organizations possessing research reactors, critical and subcritical experimental facilities, and using radiation sources and 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 other institutions using radiation sources and radioactive materials
Conformity assessment is performed in accordance with Decree No. NP enacted on 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 OBLIGATORY CERTIFICATION
IN THE FORM OF TESTS
IN THE FORM OF ACCEPTANCE
IN THE FORM OF STATE SUPERVISION
PERFORMED BY FEDERAL SERVICE FOR ENVIRONMENTAL, TECHNOLOGICAL AND NUCLEAR SUPERVISION
PERFORMED BY A CERTIFICATION BODY
PERFORMED BY PRODUCT DESDIGNER OR MANUFACTURER
PERFORMED BY PRODUCT MANUFACTURER AND OPERATING ORGANIZATION (OR ORGANIZATION ACTING UNDER ITS AUTHORITY)
Acceptance commission with participation of client (customer) designer, manufacturer, (optionally) expert organizations, and Federal service for Environmental, Technological and Nuclear Supervision
CARRYING OUT ACCEPTANCE, QUALIFICATION AND COMISSIONING TESTS FOR CONFIRMATION OF PRODUCTS COMPLIANCE WITH REQUIREMENTS OF DESIGN AND DETAIL DESIGN DOCUMENTATION
CARRYING OUT INSPECTIONS FOR CONFIRMATION OF FULFILLING SPECIFIC SUPPLY CONTRACT REQUIREMENTS (INCLUDING PERFORMING OTHER TYPES OF CONFORMITY ASSESSMENT) AND INDEPENDENT OF MANUFACTURER INSPECTIONS OF QUALITY ASSURANCE PLANS (ADDITIONAL PRODUCTS QUALITY CONTROL)
CARRYING OUT INSPECTIONS FOR CONFIRMATION OF ACTION CONDITIONS OF LICENSES FOR THE RIGHT TO MANUFUCTURE WITHIN THE CONTEXT OF SUPERVISION OVER OBSERVANCE OF FEDERAL STANDARDS AND RULES IN THE FIELD OF ATOMIC ENERGY USE
CARRYING OUT INSPECTIONS AND INDEPENDENT TESTS FOR CONFIRMATION OF EQUIPMENT, PRODUCT AND PROCESS CERTIFICATION SYSTEM REQUIREMENTS
SUBJECT TO NP , JOINT DECISION OF ROSATOM AND FEDERAL SERVICE FOR ENVIRONMENTAL, TECHNOLOGICAL AND NUCLEAR SUPERVISION No , STATE STANDARDS ON THE SYSTEM OF PRODUCTS DESIGNING AND LAUNCHING INTO MANUFACTURE
SUBJECT TO NP , JOINT DECISION OF ROSATOM AND FEDERAL SERVICE FOR ENVIRONMENTAL, TECHNOLOGICAL AND NUCLEAR SUPERVISION No , JSC “ENERGOATOM CONCERN” REGULATORY DOCUMENTS AND METHODOLOGY GUIDELINES
SUBJECT TO REGULATION ON FEDERAL SERVICE FOR ENVIRONMENTAL, TECHNOLOGICAL AND NUCLEAR SUPERVISION, NP , OTHER FEDERAL STANDARDS AND RULES IN THE FIELD OF ATOMIC ENERGY USE, AND FEDERAL SERVICE FOR ENVIRONMENTAL, TECHNOLOGICAL AND NUCLEAR SUPERVISION REGULATORY DOCUMENTS
SUBJECT TO NP , EQUIPMENT, PRODUCT AND PROCESS CERTIFICATION SYSTEM DOCUMENTS
PRODUCTS

8. FORMS OF CONFORMITY ASSESSMENT
NP 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: Licensing and 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: Obligatory for 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 QAPs based 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
Plant laboratories,
test centers
Interagency commissions
consisting of representatives
of the Client,
General Designer,
Chief Designer,
Manufacturer
and a supervision body
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
There is no industry-specific regulation for the procedures, procedures are not conducted for all products
Procedures are not conducted to the full extent, not for all products

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

12. Conformity assessment In the form of acceptance
Now conducted by JSC Zarubezhatomenergostroy and VO Safety in accordance with:
Decision of Federal Atomic Energy Agency and Federal Service for Environmental, Technological and Nuclear Supervision dated June 25, 2007 No On the Procedure and Scope of Conformity Assessment of Equipment, Components, Materials, and Semi-processed Materials, Supplied to Nuclear Facilities
NP 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
GOST R
System of product development and launching into manufacture. Procedure of product development and launching into manufacture

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

15. Products designing and launching into manufacture
According to GOST R Procedure of Product Development and Launching into Manufacture consists 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 aspects of 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
Scheme 1 envisages products samples testing for compliance with regulatory documents in a certified research center (laboratory)
Scheme 2 is an addition to scheme 1 (after issuing the certificate) – follow-up inspection control via testing a product sample from the market
Scheme 2a is 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 testing of samples taken from the manufacturer’s finished products warehouse before sending them to the customer
Scheme 3a envisages an addition to scheme 3 (before issuing the certificate for the product) – analysis of the status of manufacturing of products being 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 4a involves an addition to scheme 4 (before issuing the certificate) – analysis of the status of manufacturing of products being certified using methods elaborated by the certification body
Scheme 5 is based on testing products and certification of manufacture or quality system with a follow-up inspection, manufacture conditions stability control, and quality system functioning
Scheme 6 involves testing the producer quality system certification on the basis of a special document
Scheme 7 specifies testing a sample, selected from a batch of produce
Scheme 8 is based on testing every single item for compliance with requirements of regulatory and other documents

18. Control of design and process documentation
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 Regulation on Quality Control of Manufacturing of Equipment for Nuclear Power Plants
Methodology Guidelines Arrangement of 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 Rosenergoatom and 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 inspections of equipment at design and engineering enterprises and manufacturing plants were carried out by Federal Service for Environmental, Technological and Nuclear Supervision
After its functions changed (Law on technical regulation), Federal Service for Environmental, Technological and Nuclear Supervision deals only with regulation via control over action conditions of licenses being issued
The necessity of independent inspection over the compliance with standards and rules on safety while designing and manufacturing the equipment is defined by both clients’ (operating organizations, supplier enterprises, etc.) requirements and the IAEA international requirements
There are no efficient mechanisms of correcting conformity assessment procedures in case nonconformities or defects are detected while checking formally compliant equipment (manufactured at enterprises which 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/or owners
suspension of manufacture, obsolence of equipment
loss of personnel
decline in manufacturing culture
loss of communication with suppliers of materials, semi-processed materials and components
large volume of low quality imported items
Positive factors:
nuclear Renaissance
NPPs construction abroad assuring compliance with international 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 standards requirements
Personnel compliance with international standards requirements
Manufacture and business compliance with requirements
Independent (of the ordering customer) conformity confirmation
Difficulties:
Insufficient legislative framework on responsibility for quality in the field of atomic energy use
Complicated and not exactly objective system of licensing in the field of nuclear energy use
Insufficient elaboration 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 can point out the necessity of requirements);
Time pressure;
Approval of design documentation by the start of manufacture;
Obligatory carrying out of the procedure of launching into manufacture, test samples, tests (absence of tests results in insufficient qualification) as a consequence of 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 system of 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 unified nonconformity and technical decisions management system. Classification

24. proposals
Experience in quality control and conformity assessment suggests good prospects for 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 migration is 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 to unify 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” Project In 2013 as part of the project the following industry regulatory documents were elaborated 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-P dated July 31, 2013
Project - Optimization of examination of the milestone Enterprise's readiness for manufacturing at Atomenergomash enterprises Feb–Jun, 2013
Temporary procedure of acceptance inspections in organizations manufacturing of equipment of safety classes 1, 2, and 3 introduced by Order № 1/1036-P dated September 27, 2013
Project - Optimization of examination of the milestone Acceptance inspection at Atomenergomash enterprises Feb–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-P dated December 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 certificates for pipe and assembly units for a nuclear power unit pipeline introduced by Rosatom State Corporation Order №1/1311-P dated 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 certificates for pipe and assembly units for a nuclear power unit pipeline , Passport of a nuclear power unit pipeline Jul–Nov, 2013
Industry document Regulation on industrial material organization enacted by Order № 1/1255-P dated 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 were elaborated 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 in 2014
Standardization of procedures of conformity assessment of materials, components and equipment imported in the Russian Federation
Creating an industrial data 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 for Quality 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