Approved
by
Decree of the
Federal
Environmental, Industrial and
Nuclear Supervision
Service dated
September, 5, 2006 No. 4
Effective
from July, 01, 2007
FEDERAL
RULES AND REGULATIONS
IN THE AREA OF ATOMIC ENERGY USE
RULES OF
CONFORMITY ASSESSMENT FOR EQUIPMENT, COMPONENTS, MATERIALS
AND SEMI-FINISHED PRODUCTS SUPPLIED TO
NUCLEAR FACILITIES
NP-071-06
These federal regulations and rules "Rules of conformity assessment for equipment, components, materials and semi-finished products supplied to nuclear facilities" establish the rules of conformity assessment for equipment, components, materials and semi-finished products supplied to nuclear facilities.
They shall be mandatory for manufacturing and supply of any equipment for nuclear facilities.
First issue <*>.
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<*> The document is developed by the working group with the following membership: V.A. Grivizirsky, V.E. Melamed, N.A. Karpenko (Rostechnadzor), I.V. Kaliberda, V.Sh. Plekhanov, V.P. Slutsker (Scientific and Technical Center for Nuclear and Radiation Safety), V.V. Kozlov, A.V. Safronov, A.V. Ageev (VO Safety FSUE), L.M. Rusinova (Rosatom), V.A. Beletsky (Concern Rosenergoatom), L.I. Vikhornov (KPI).
Proposals of Rostechnadzor and Rosatom specialists are reviewed and taken into account in the course of the document development.
The document is developed with due regard for the provisions of Federal Law "On atomic energy use", the federal regulations and rules in the area of atomic energy use, recommendations of the IAEA documents "Quality assurance for safety of nuclear power plants and other nuclear installations. Safety code and guidelines".
The regulatory document has passed legal examination at the Russian Ministry of Justice (Letter of the Russian Ministry of Justice dated September, 15, 2006 No. 01/8119-ÎÕ).
1. Purpose and scope of application
1.1. These federal regulations and rules "Rules of conformity assessment for equipment, components, materials and semi-finished products supplied to nuclear facilities" (hereinafter - the Rules) establish the requirements for conformity assessment of the equipment, products used as parts of the equipment or other components (hereinafter - components), materials and semi-finished products supplied to the nuclear facilities.
1.2. These Rules shall be applied in the course of manufacturing and supply of any equipment for safety-related elements of nuclear facilities referred to safety classes 1, 2 and 3 established in accordance with the federal regulations and rules in the area of atomic energy use as well as any components, materials and semi-finished products to be used in the elements referred to these classes except for nuclear materials, fresh and spent nuclear fuel.
2. General provisions
2.1. Equipment, components, materials and semi-finished products supplied to any nuclear facilities shall be subject to conformity assessment in accordance with the requirements of federal regulations and rules in the area of atomic energy use prescribed for the equipment and (or) systems of nuclear facilities comprising this equipment, components, materials and semi-finished products as well as any other documents included into the technical assignments, technical specifications and technical requirements in accordance with the established procedure.
2.2. Documentation for the equipment, components, materials and semi-finished products shall be analyzed prior to conformity assessment in order to define specific requirements for the conformity assessment implied by their operation conditions at the nuclear facility.
3. Conformity assessment for the equipment, components,
materials and semi-finished products supplied to nuclear facilities
3.1. General provisions
3.1.1. The following conformity assessment forms shall be used to assess conformity of the equipment, components, materials and semi-finished products supplied to nuclear facilities: governmental control (supervision), testing, acceptance, confirmation of conformity.
3.1.2. It is permitted to use only some forms of conformity assessment for particular equipment, components, materials and semi-finished products in case the possibility to apply lesser quantity of conformity assessment forms is provided.
3.1.3. Quality plans attached to the equipment certificates shall be reviewed in the course of conformity assessment for the equipment designed and manufactured for use in the systems and elements of nuclear facilities (hereinafter - the special-purpose equipment). The quality plans shall contain records on the performed works and implemented arrangements. The recommended quality plan content is given in Appendix 1.
3.2. Conformance assessment in the form of testing
3.2.1. Conformity assessment for equipment, components, materials and semi-finished products arranged in the form of testing shall be performed:
- in the course of incoming control of the equipment, components, materials and semi-finished products;
- in the course of manufacturing;
- upon completion of manufacturing;
- in the course of installation, commissioning works, the equipment commissioning at the nuclear facility (in case of separate supply of large-scale and multi-component equipment to the nuclear facility by one or several suppliers when the equipment can be tested only at the nuclear facility).
3.2.2. Testing in the course of manufacturing of the equipment, components, materials and semi-finished products shall be performed in accordance with the quality plans, production processes, testing programs and methodologies. In this case each subsequent stage of manufacturing (each manufacturing process operation where necessary) may be commenced only upon completion of control and testing at the previous stage with development and approval of the relevant reporting documents by the manufacturer and the operating organization.
3.2.3. In case any sampling tests are performed statistical methods shall be applied for processing of the testing results in order to obtain reliable data.
3.2.4. Equipment, components, materials and semi-finished products shall not be supplied to or used at the nuclear facility unless all operations specified in the quality plans, testing programs and methods are completed with the results confirming their compliance with the established technical requirements.
3.2.5. Pilot samples and (or) prototypes (the first production lot) of special-purpose equipment shall be subject to acceptance testing.
3.2.6. In case the federal regulations and rules in the area of atomic energy use and the regulatory documents included into the technical assignment provide for sampling of the equipment in order to perform acceptance testing of the special-purpose equipment this sampling shall be carried out in accordance with the requirements of these documents in presence of the acceptance committee representatives. The samples shall have designation for the purpose of identification.
3.2.7. Site acceptance testing of the equipment, components, materials and semi-finished products shall be carried out in accordance with programs and methodologies of these tests. Testing shall confirm compliance of the equipment, components, materials and semi-finished products having passed the previous control and testing stages with the established requirements.
3.2.8. Results of the site acceptance testing shall be documented with indication of:
- the testing program and methodology;
- the particular equipment, components, materials and semi-finished products having passed the testing and (or) the testing stage;
- the testing date;
- types of tests;
- testing equipment and the applied measuring devices, information on their validation or calibration;
- certificate of the testing personnel qualification conformity to the established requirements;
- materials with the testing results, their analysis and assessment;
- information on the specialists having performed such assessment or analysis.
3.2.9. In case the testing results demonstrate any non-compliance of the parameters (characteristics) of equipment, components, materials and semi-finished products with the prescribed technical requirements any consequences of the detected deviations shall be defined, and the relevant corrective measures shall be developed, approved by the operating organization or any organization acting on its behalf and reviewed by the state regulatory authority for safe atomic energy use in order to apply this equipment, components, materials and semi-finished products at the nuclear facility.
3.2.10. In case implementation of these corrective measures does not ensure compliance with the established requirements the equipment, components, materials and semi-finished products shall not be used at the nuclear facility.
3.3. Conformity assessment in the form of governmental control (supervision)
Conformity assessment for equipment, components, materials and semi-finished products in the form of governmental control (supervision) shall be performed within the framework of control and surveillance over compliance with the federal regulations and rules in the area of atomic energy use and conditions of the manufacturing licenses issued by the state regulatory authority for safe atomic energy use.
3.4. Conformity assessment in the form of acceptance
3.4.1. Conformity assessment in the form of acceptance shall be mandatory for special-purpose equipment.
3.4.2. The following shall be confirmed subsequent to the acceptance results:
- performance of the procedures and processes prescribed in the technical documentation;
- performance of the full scope of control and testing in the course of manufacturing;
- availability of the documents with the control and testing results;
- elimination of any detected non-conformities.
3.4.3. Spare parts for special-purpose equipment and components of special-purpose equipment supplied for performance of repair works at the nuclear facility shall be subject to acceptance within the same scope as for the special-purpose equipment.
3.4.4. Conformity assessment in the form of acceptance may not be carried out for the equipment if its compliance with the established requirements is confirmed by the conformity certificate in the Certification system for equipment, products and technologies for nuclear installations, radiation sources and storage facilities.
3.5. Conformity assessment in the form of conformity confirmation
3.5.1. Conformity assessment for equipment, components, materials and semi-finished products for nuclear facilities performed in the form of conformity confirmation shall be carried out in the Certification system for equipment, products and technologies for nuclear installations, radiation sources and storage facilities in the form of mandatory certification.
3.5.2. Compliance of the characteristics (parameters) of the equipment, components, materials and semi-finished products intended for nuclear facilities with the technical requirements prescribed in the federal regulations and rules in the area of atomic energy use as well as any other documents included into the technical assignments, technical specifications and technical requirements in accordance with the established procedure shall be checked in the course of mandatory certification.
3.6. Peculiarities of conformity assessment for general-purpose industrial equipment
3.6.1. Requirements for conformity assessment with regard to general-purpose industrial equipment integrated into the nuclear facility elements referred to safety classes 1, 2 and 3 established in accordance with the federal regulations and rules in the area of atomic energy use shall be specified by the developer of the design or the nuclear facility elements based on analysis of the equipment parameters (characteristics) as well as the equipment operation conditions at the nuclear facility.
In case any need for additional conformity assessment procedures (testing, conformity confirmation) is detected subsequent to the analysis results these procedures shall be performed.
3.6.2. Positive analysis results and (or) conformity assessment results confirming compliance of the equipment parameters (characteristics) with the requirements prescribed in the area of atomic energy use shall be used as the basis for application of the general-purpose industrial equipment at the nuclear facility. The results of analysis and conformity assessment shall be presented together with the supporting documentation.
3.7. Peculiarities of conformity assessment for components, materials and semi-finished products
3.7.1. Components, materials and semi-finished products intended for manufacturing, repair and refurbishment of special-purpose equipment or systems of nuclear facilities referred to different safety classes shall comply with the regulatory requirements for components, materials and semi-finished products of the highest class, or shall have distinctive labeling.
3.7.2. Components, materials and semi-finished products having certificates, data sheets or any other documents confirming their compliance with the prescribed requirements shall be used for manufacturing of special-purpose equipment.
3.7.3. In case the scope of the characteristics and parameters (including the reliability parameters) of the components, materials and semi-finished products confirmed by documents is not sufficient with due regard for the potential operation conditions at the nuclear facility for the special-purpose equipment where they are to be applied any necessary additional testing of the components, materials and semi-finished products shall be performed.
3.7.4. In the course of conformity assessment for the materials (including new ones) applied in the equipment of the nuclear facilities it shall be confirmed that they are permitted for use at nuclear facilities in accordance with the requirements of the federal regulations and rules in the area of atomic energy use or any other documents.
3.7.5. Availability of information in the form of labeling or any other designation used to identify components, materials and semi-finished products (particularly the information on their shelf life limits) shall be checked in the course of conformity assessment.
3.8. Peculiarities of conformity assessment for imported equipment, components, materials and semi-finished products
3.8.1. Conformity assessment for imported equipment, components, materials and semi-finished products shall be performed with:
- audit of production facilities for manufacturing of particular imported equipment, components, materials and semi-finished products;
- expert review of the documentation for imported equipment, components, materials and semi-finished products substantiating their quality and safety;
- acceptance testing (for prototypes) or site acceptance testing.
3.8.2. Acceptance or site acceptance testing may be omitted in the course of conformity assessment for imported equipment, components, materials and semi-finished products:
- electrical and radio products (including electrical, radio-technical and electronic items used as the components for manufacturing of electrical and electronic instruments, hardware, devices and units, namely solid-state devices (microchips, transistors, diodes, etc.), resistors, capacitors and other electronic components);
- basic and welding materials.
The above-mentioned components, materials and semi-finished products shall be subject to assessment within the equipment they are intended for.
3.8.3. Prior to acceptance or site acceptance testing in the course of conformity assessment for imported equipment, components, materials and semi-finished products the operating organization or any independent expert organization shall analyze the information according to the list given in Appendix 2.
3.8.4. Results of acceptance or site acceptance testing for the imported equipment confirming its compliance with the established technical requirements shall be used as the basis for its application at the nuclear facility. The testing results shall be registered in reports and certificates; one copy of these reports and certificates shall be attached to the equipment data sheet.
All conformity assessment documentation shall be issued in Russian.
Appendix 1
(for reference)
RECOMMENDED QUALITY PLAN CONTENT
It is recommended to include the following into the quality plan:
- general information: - the name of the nuclear facility, the contract number, the name of special-purpose equipment, the registration number of the quality plan;
- the list of sequential process operations for the equipment manufacturing, testing and inspection;
- the list of the equipment components subject to manufacturing and inspection;
- references to the procedures and working instructions to be followed in performance of the operations specified in the plan;
- information on the departments performing control and testing of any component (operation);
- information on representatives of the operating organization (or any organization acting on its behalf) at the checkpoints where their participation in the quality conformity assessment is expected;
- full title of the documents where the results of each acceptance and testing operation are recorded as well as references to the relevant documents demonstrating the control and testing results;
- information on the authorities of the manufacturing organization personnel for control and testing and the personnel of the operating organization (or any organization acting on its behalf) for acceptance and testing at the manufacturing process checkpoints ("hold points" and "witness points").
Notes.
1. Authorities of the personnel at the "hold points" mean:
- for the manufacturing organization personnel - the manufacturing process shall be suspended so that the representative of the operating organization (or any organization acting on its behalf) could carry out acceptance or testing (any further performance of the production operations shall be impossible without his/ her approval);
- for the personnel of the operating organization (or any organization acting on its behalf) - the manufacturing process shall be suspended so that the representative of the operating organization (or any organization acting on its behalf) and the representative of the state regulatory authority for safe atomic energy use (in case of necessity) could carry out surveillance over the manufacturing process or take part in acceptance or testing (any further performance of the production operations shall be impossible without approval of the representatives of the above-mentioned organizations).
2. Authorities of the personnel at the "witness points" mean:
- for the manufacturing organization personnel - by the moment of the checkout operation the representative of the operating organization (or any organization acting on its behalf) shall be informed that the production facility section is ready for acceptance or testing (in this case manufacturing of the equipment shall not be stopped in the course of acceptance or testing);
- for the personnel of the operating organization (or any organization acting on its behalf) - by the moment of the checkout operation the representative of the operating organization (or any organization acting on its behalf) and the representative of the state regulatory authority for safe atomic energy use (in case of necessity) shall be ready to carry out acceptance or testing operations.
Appendix 2
(for reference)
INFORMATION TO BE ANALYZED FOR IMPORTED EQUIPMENT,
COMPONENTS, MATERIALS AND SEMI-FINISHED PRODUCTS
The following shall be analyzed in the course of conformity assessment for imported equipment, components, materials and semi-finished products:
- compliance with the laws of the Russian Federation and the federal regulations and rules in the area of atomic energy use applicable to the functional area of the equipment, components, materials and semi-finished products;
- identity (equivalence) of the requirements of any national or international regulatory documents to the requirements of the Russian regulatory documents in case the imported equipment, components, materials and semi-finished products are to be developed, manufactured and tested in accordance with the requirements of national or international regulatory documents;
- technical requirements for the equipment, components, materials or semi-finished products;
- information on any positive experience in application of the equipment, components, materials and semi-finished products or their counterparts at nuclear facilities;
- information on any potential deterioration of the design parameters (characteristics) of any systems where imported equipment, components, materials and semi-finished products are to be used as well as information on the possibility for any safety deficiency occurrence during performance of the functions by other nuclear facility systems.