Decree No. 214 / 1997 Coll.
Decree of the State Office for Nuclear Safety on Quality Assurance in Nuclear Energy Use and Radiation Activities, and on the establishment of criteria for the inclusion and distribution of selected equipment in safety classes
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05.09.1997
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214
DECLARATION
State Office for Nuclear Security
of 15 August 1997
on quality assurance in nuclear energy-related and irradiated activities and establishing criteria for the classification and distribution of selected equipment in safety classes
According to § 47 (7) for the implementation of § 2 (i), § 4 (7), § 13 (3) (d) and § 5 of Act No. 18 / 1997 Coll., on the Peaceful Use of Nuclear Energy and Ionising Radiation (Atomic Act) and amending and supplementing certain laws, hereinafter referred to as "the Act":
INTRODUCTORY PROVISIONS
Subject matter and scope of the adjustment
Order edits
(a) the introduction of a quality system;
(b) quality system requirements;
(c) quality assurance requirements for selected equipment with regard to their classification in safety classes;
(d) requirements for the content of quality assurance programmes;
(e) criteria for the classification and distribution of selected installations into security classes;
(f) the scope and manner of implementation of the list of selected devices.
Introduction of the quality system
(1) The quality system for activities related to the use of nuclear energy and for activities resulting from exposure in addition to the activity referred to in § 2 (a) (6) of the Act must be introduced to the minimum extent required under § 3 to 5 of this Decree.
(2) A quality system for the placing or construction of a workplace with a very significant source of ionising radiation, the operation of a workplace with a significant or very significant source of ionising radiation1) and the management of radioactive waste from nuclear installations must be implemented within the scope of the requirements of Sections 3 to 20 of this Decree. This provision shall not apply to intermediate workplaces with sources of ionising radiation.
(3) The quality system for the activities of placing, construction, putting into service, operation and decommissioning of nuclear installations must be implemented within the scope of the requirements of Sections 3 to 24 of this Decree. This provision also covers to an appropriate extent important activities related to the design and implementation of the reconstruction of nuclear installations and parts thereof, the design, manufacture, assembly, maintenance, repair and verification of selected installations, including materials for their production and handling of replacement parts of selected installations.
(4) It is necessary to establish and document the quality system for the activities referred to in paragraph 1 before carrying out the activities concerned.
(5) The quality system for authorised activities under Section 9 of the Act must be documented in the form of quality assurance programmes, the content of which is provided for in Section 32 of this Decree, follow-up documentation on quality assurance and records for all activities relevant to nuclear safety and radiation protection and introduced by the permit holder prior to the issue of the relevant authorisation.
(6) The quality system for placement, construction, entry into service and operation activities, including decommissioning of nuclear installations, includes not only activities directly carried out by the authorisation holder, but also activities relevant to nuclear safety and radiation protection, carried out in a supplier's or sub-contractor's way and must be implemented and documented as a whole.
QUALITY REQUIREMENTS
Before carrying out activities related to the use of nuclear energy and to irradiation activities within the meaning of Article 2 (1) of this Decree,
(a) products, activities, relationships, systems and persons (hereinafter referred to as "items") relevant to nuclear safety and radiation protection,
(b) the responsibilities, powers and links of persons managing, carrying out, evaluating and verifying activities affecting the quality of items relevant to nuclear safety and radiation protection;
(c) procedures for sub-activities or their integrated nuclear safety and radiation protection systems (hereinafter referred to as "processes") are established and documented;
(d) adequate financial, personnel, technical and other resources and the conditions necessary for the performance of activities affecting the quality of items of nuclear safety and radiation protection.
Before carrying out activities within the meaning of Paragraph 2 (1) of this Decree, the method and frequency of evaluation of the quality system must be determined in terms of its suitability and efficiency in relation to the requirements laid down.
In carrying out activities related to the use of nuclear energy and to the activities resulting from exposure within the meaning of Article 2 (1) of this Decree, the following must be:
(a) documented, implemented, implemented and verified processes to ensure that their outputs (hereinafter referred to as "products") comply with the requirements set (technical regulations, agreed specifications, standards, technical conditions, agreed administrative rules and procedures, etc.);
(b) records shall be kept of the results of the quality system evaluation and process verification;
(c) ensure that the natural persons who manage, verify, evaluate and carry out the processes comply with the established qualifications and are trained.
Processes directly affecting the quality of items of nuclear safety and radiation protection are planned and conducted under controlled conditions. Such controlled conditions shall include:
(a) documented procedures;
(b) suitable equipment and suitable environmental conditions to meet the quality requirements of the item;
(c) compliance with the documentation provided;
(d) monitoring of item parameters and characteristics;
(e) the approval of documentation by authorised persons;
(f) clear and understandable criteria for the quality of the item;
(g) appropriate maintenance of equipment to ensure the durable capacity of the item;
(h) the pursuit of activities by qualified persons.
(1) The draft contract, the subject matter of which relates to items affecting nuclear safety and radiation protection, must be subject to an early review process before the contract is concluded and a written record of such review must be made.
(2) The contractual process must ensure that:
(a) a clear and sufficient contractual formulation of the requirements relating to the quality of the items, quality assurance and quality records;
(b) the ability of the Contracting Party to comply with the contractual requirements referred to in (a);
(c) the way in which amendments to contracts are made.
(3) A check or verification by the collector of the item delivered which affects nuclear safety and radiation protection in terms of compliance with the requirements referred to in paragraph 2 (a) shall be agreed by contract.
(1) Measures to ensure compliance of the items supplied with the contractual requirements, as well as measures to ensure:
(a) evaluation and approval of suppliers, including supervision of suppliers, and the setting of criteria for such approval and evaluation;
(b) sufficient scope and frequency of supervision of suppliers, depending on the importance of the item supplied in terms of nuclear safety and radiation protection;
(c) that the documentation for the provision contains correct and complete requirements for the item to be procured, for processes related to the item, including requirements for verification of these processes and for the extent of the quality of the item to be procured.
(2) The records showing that the items comply with the procurement requirements shall be available before the relevant item is used and shall adequately demonstrate that the individual requirements have been met for the received item.
For the process of creation, development, construction and design (hereinafter referred to as the "design process') of items, provision must be made for measures to ensure:
(a) compliance with nuclear safety and radiation protection requirements for the proposed item;
(b) the planning of sufficient resources to ensure the award, creation, review and verification of the item design;
(c) defining the organisational and technical interface between the organisational bodies of persons and individual persons entering the design process;
(d) monitoring, recording, verifying and reviewing the accuracy and completeness of relevant information in terms of nuclear safety and radiation protection, transmitted within the interface;
(e) in the design process and in its documented outputs, taking into account the requirements of legislation affecting items and agreed specifications, standards, technical conditions, rules and procedures with particular regard to nuclear safety and radiation protection, with derogations from those requirements being identified and recorded;
(f) reviewing the accuracy of the award and the subsequent review record;
(g) the processing of the documentation of the resulting output from the design process in order to allow for its examination and verification;
(h) planning and carrying out an examination of the output documentation of the design process before its release at appropriate stages, both by those involved in the production and by impartial sufficiently qualified persons, as appropriate and by the importance of the facts reviewed and the keeping of records of such review;
(i) that any changes to the output documentation of the design process are documented, reviewed and agreed in a similar manner to the original documentation by authorised persons, taking into account the seriousness of the change.
Procedures for handling documentation and data relevant to nuclear safety and radiation protection shall ensure:
(a) review and agree on the accuracy, completeness and suitability of the documentation and data relevant to nuclear safety and radiation protection, including changes thereto by authorised persons before release;
(b) identifying the current situation and subsequently determining and introducing such measures to prevent the use of invalid documentation and data;
(c) unambiguous identification of documentation and data;
(d) establishing the storage and archiving periods of documentation and data, with the need to be available at those posts where they are necessary for the performance of the activities;
(e) to make available to all persons carrying out activities relevant to nuclear safety and radiation protection all documentation and data necessary to carry out the activity, in a language that allows them to understand the subject in a perfect way.
(1) In order to identify products relevant to nuclear safety and radiation protection during the stages associated with these products, procedures shall be established to ensure:
(a) unambiguous identification and its execution by appropriate means either directly on the product or in the form of records relating to the product;
(b) to prevent the incorrect use of the product or part thereof in advance;
(c) the identification mark on the product does not reduce the level of the quality characteristics of the product relevant for nuclear safety and radiation protection.
(2) Where traceability of a product is required, procedures shall be laid down for stages linked to the product concerned to ensure that the traceability of the product and the traceability of the product are at any time traceable.
(3) The traceability referred to in paragraph 2 is required for selected installations and parts thereof during production, assembly, inspection, transport, storage, putting into service and operation.
(4) Traceability is also required when dealing with sources of ionising radiation, radioactive waste and nuclear materials.
(1) For control and testing processes to verify the quality of a product of nuclear safety and radiation protection importance, plans and procedures for their implementation must be developed,
(a) where the check has points which require witness verification without which it is not possible to proceed, these specific node points must be indicated in the relevant documentation;
(b) checks and tests shall be carried out and evaluated in the sequence specified in the relevant programmes and plans;
(c) the start of the follow-up or test activities must be subject to either a successful evaluation of the inspection or test or a product review, unless it complies with the specified requirements;
(d) control and test procedures shall include provisions to ensure the necessary conditions for the inspection or test, including environmental conditions and criteria for evaluating the results.
(2) Records must be established and maintained showing that the product has been checked or tested and that it has complied with the criteria set.
For checking, calibration and maintenance of the control, measuring and testing equipment, procedures shall be established to ensure that the measurement uncertainty is known and corresponds to the required measurement capability.
In order to indicate the state of the product relevant for nuclear safety and radiation protection by appropriate means after its inspection and tests, procedures shall be carried out to ensure that only a product which has successfully undergone the required checks and tests or has been released after the procedure for the non-conformity product is used.
The process of product management relevant to nuclear safety and radiation protection that does not meet the quality requirements ("non-compliant product ') ensures that:
(a) the non-compliant product has been examined and either repaired or reprocessed or used without repair or reprocessing, but subsequently its quality must not be further reduced in order not to adversely affect the level of nuclear safety and radiation protection;
(b) without examination of the non-conformity product and the subsequent recording of the decision on any repair, reprocessing and use thereof referred to in (a), the non-conformity product has not been used;
(c) the reworked or repaired product has been subjected to rechecks and tests for those quality indicators which may be affected under the same or comparable conditions as the original product.
(1) In order to ensure an immediate identification of the conditions and non-conformities adversely affecting the level of nuclear safety and radiation protection, procedures must be developed to ensure that the causes of those conditions and non-conformities are found and corrective actions are carried out to resolve and prevent non-conformities.
(2) Procedures shall be developed for processes designed to eliminate the causes of possible non-conformities ("preventive measures').
(3) It is necessary to ensure that the procedures referred to in paragraphs 1 and 2 include measures to record changes resulting from corrective and preventive measures.
The processes of handling, storage, packaging, protection and delivery of a product important in terms of nuclear safety and radiation protection shall be designed in such a way as not to damage or reduce the required quality level of the product.
In the identification, collection, registration, storage, archiving, maintenance and shredding of records relevant to nuclear safety and radiation protection ("the records'), it is necessary to:
(a) maintain records to demonstrate compliance of the item with the requirements laid down;
(b) ensure that the records are legible and prevent their loss, destruction, unauthorised treatment or any other deterioration;
(c) set time limits for the storage and archiving of records;
(d) ensure that records are clearly identifiable, available for use and are archived at least throughout the lifetime of the relevant item to which the records relate, so that the status of items relevant to nuclear safety and radiation protection for which traceability is required can be always traced, where appropriate.
The process of planning and carrying out quality assurance checks to verify compliance of the quality system in place with this decree shall ensure that:
(a) the examinations have sufficient scope and regularity to verify, on the basis of the results of such examinations, at least every two years, the full quality system for compliance with the requirements of this Decree;
(b) the results of the verifications are recorded and presented to the persons responsible for the area under examination;
(c) the examinations are carried out by non-party persons with sufficient qualifications and experience, which are not functionally dependent on those responsible for the work to be carried out;
(d) the measures to remedy and remedy deficiencies have been taken in a timely manner and have been subsequently examined.
In order to identify training needs and to ensure the self-training of personnel affecting the quality of items relevant to nuclear safety and radiation protection, procedures containing:
(a) establishing qualification criteria for such staff;
(b) the manner in which the training and qualifications acquired are kept and maintained;
(c) the way in which he can provide demonstrable training for appropriately qualified personnel in order to be able to carry out the assigned work and to understand the importance of its activities in terms of nuclear safety and radiation protection.
(1) Procedures for the selection and assessment of the suitability of the use of individual items necessary for the performance of functions relevant to nuclear safety, including individual selected installations and their materials, shall be established and documented for the nuclear equipment design process, so as to meet the requirements for the nuclear equipment project.
(2) The documentation of the design of the nuclear installation shall include evidence that the types of equipment, systems, software and structures covered by the selected equipment are suitable and their parameters and arrangements meet the requirements for the nuclear installation project.
(3) Verification of the design process of a nuclear installation shall be carried out, including the examination of the output documentation, by impartial sufficiently qualified persons not involved in the original preparation of the documented design.
(4) The documentation of the design of the nuclear installation shall be reviewed in terms of nuclear safety and agreed by sufficiently qualified persons designated by the authorisation holder at appropriate agreed stages.
(5) Assessment, supporting calculations, analyses and analyses in the nuclear plant design process must be recorded in such a way that they can be reviewed and verified.
(6) The procedures for verifying the design of nuclear installations shall be established in such a way as to ensure that the accuracy of the design is verified by appropriate methods such as analysis and analysis using alternative calculation methods, application of an appropriate test programme, comparison with a similar tested design and examination of the design documentation before release.
(7) The design of a nuclear installation shall be verified for normal, abnormal and emergency conditions, including considered overdesign events, from the point of view of protection against ionising radiation and nuclear safety and in particular from the point of view of:
(a) reactor physics;
(b) thermopraulics; and
(c) the stress, reliability, performance and durability of the selected equipment.
(8) The design of a nuclear installation shall further verify:
(a) the suitability of the materials used for the selected equipment;
(b) accessibility for inspections during operation and for the maintenance, repair and possible replacement of selected equipment;
(c) a draft of the methods and criteria of acceptability for the checks and tests of selected establishments; and
(d) the inclusion of selected equipment in security classes.
(1) Processes in the operation of nuclear installations must be documented in particular for these areas in the case of buildings involving a nuclear reactor.
(a) traffic management, including abnormal operation and destruction of failures and accidents;
(b) outage management;
(c) notification and evaluation of accidents and events;
(d) the management of experiments and tests;
(e) the management of exchange personnel,
(f) qualification and training of staff;
(g) maintenance and repair of selected equipment (including marking and securing);
(h) testing and checking of selected equipment and software during operation, including evaluation of their results;
(i) evaluation of the state of the selected installations and drawing on their lifetime;
(j) the implementation and design of amendments and reconstruction, including the development of security documentation for such changes;
(k) preservation, storage and protection of selected equipment and spare parts for selected equipment;
(l) calibration of measuring instruments;
(m) nuclear fuel management;
(n) the management of radioactive waste,
(o) the management of discharges;
(p) chemical regimes;
(q) radiation protection;
(r) environmental monitoring;
(s) fire protection;
(t) physical protection;
(u) emergency preparedness and planning.
(2) For other nuclear installations, paragraph 1 shall apply to the extent applicable to that type of installation.
(1) Welding processes, non-destructive testing, heat treatment, software production and other processes for which the results cannot be fully verified by follow-up inspection and testing, hereinafter referred to as "special processes", must have qualification criteria and meet those qualification criteria. The specific processes shall be carried out by sufficiently qualified persons whose knowledge and competence to carry out activities is regularly examined.
(2) Equipment for the implementation of specific processes must be eligible and such competence checked.
(3) Records shall be kept of compliance with the qualification criteria and of the verification of competence referred to in paragraphs 1 and 2.
(1) Verification of compliance with the requirements for processes or items shall be carried out by both persons involved in such processes or the formation of items, and by independent or external persons entrusted with the performance of independent verification, at the appropriate level of control of the person to whom the verification is carried out.
(2) The evaluation of the quality system shall be carried out by representatives of all levels of process management and of the items covered by the quality system, as well as by independent or external persons entrusted with the performance of the independent evaluation, at the appropriate level of management of the person to whom the evaluation is made.
(3) The methods and results of the verification referred to in paragraph 1 and the evaluation referred to in paragraph 2 must be recorded by the persons who carried out the verification or evaluation.
(4) Persons carrying out independent verifications in accordance with paragraph 1 or independent evaluations in accordance with paragraph 2 shall not directly participate in or manage processes or items subject to verification and shall have sufficient power to transmit the results and reports of their verifications or evaluations to the highest level of management of the person for whom verification or evaluation is carried out.
(5) The results of the independent verification and evaluation must be taken into account and, where necessary, corrective action must be taken.
(6) The evaluation of the quality system and the inspection and verification of the quality and quality assurance of the items of nuclear safety important to the customer and the holder of the relevant authorisation with the supplier must be agreed by contract.
(7) Pending the evaluation of the possible consequences of the identified non-conformities of items relevant to nuclear safety, the non-compliance shall be considered as a defect in terms of its extremely adverse impact on nuclear safety and appropriate measures shall be taken.
REQUIREMENTS FOR THE SAFETY OF THE PERFORMANCE OF SELECTED EQUIPMENT
Selected equipment must be clearly identified before ordering for nuclear equipment and their listing documented in the form of a list of selected equipment.
The documentation of the supplier of the selected quality assurance devices (quality manuals, quality assurance manuals, quality plans, etc.) shall be reviewed and agreed by the relevant authorisation holder and a record of such reconciliation shall be made.
(1) The design process of the individual selected security class 1 devices and of the equipment and systems covered by safety class 2 shall be subject to the requirements of Section 21 of this Decree as appropriate.
(2) The resulting documented design of the selected Security Class 1 equipment and of the equipment and systems covered by Security Class 2 shall contain the quality criteria necessary to ensure nuclear safety-critical functions.
(3) The resulting documented design of the selected equipment shall include the determination and justification of the expected lifetime of the selected equipment or parts thereof and the conditions for the handling and operation of the selected equipment.
(4) The selected equipment, indicating the safety classes, shall be indicated in the design specifications or in the design drawings and drawing documentation of the actual state of the nuclear installation.
(5) Where a test programme is applied instead of other verification processes to verify the accuracy of certain project characteristics of the selected equipment, this programme shall include appropriate prototype competence tests under the worst possible project conditions. The results of the verification shall be recorded.
(1) The records relating to the specific processes referred to in Section 23 (3) of this Decree, the quality records and the verification records of the design of selected equipment of Safety Classes 1 and 2, which contain evidence that all the quality criteria of nuclear safety relevant to the selected equipment, their parts and the materials used have been met, shall be archived, maintained and supplemented at all stages of the life of the selected equipment, starting from the design of the selected equipment and its parts, to its decommissioning.
(2) The quality records referred to in paragraph 1 shall include records of the quality of the selected security class 1 devices and of the security class 2 devices loaded with internal overpressure, showing the location, size, frequency and type of defects detected by the inspection, the manner in which they are corrected and the permissible defects retained (size, frequency, type, location, etc.). The method of detection of defects and the admissibility of defects in terms of their size and character shall be included in the design of the selected device.
(3) The holder of a permit to operate a nuclear installation shall ensure that records of the quality of the selected equipment of Safety Classes 1 and 2 are kept, archived, maintained and supplemented to such an extent and quality as to enable the condition of the selected equipment to be assessed at any time.
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Regulation Information
| Citation | Decree of the State Office for Nuclear Safety No. 214 / 1997 Coll., on Quality Assurance in Nuclear Energy Use and Radiation Activities, and on the establishment of criteria for the classification and distribution of selected equipment into safety classes |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 05.09.1997 |
|---|---|
| Effective from | 05.09.1997 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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