This is a local document of the enterprise, which allows to control the quality of the work performed and the services provided, as well as supervision over the proper provision of safety at production facilities, whose activities are related to the use of nuclear energy (NF).
The cost of compiling a POC is 25,000 rubles. Terms - from 5 days.
If necessary, a certificate of conformity to the ISO quality system can be issued. The price is 10,000 rubles.
This type of documentation contains a list of organizational and technical measures developed and implemented as part of the control that affect the safety of the object of activity.It includes the distribution of responsibility between managers and personnel of the enterprise, as well as a list of materials used in the implementation of these measures.
The need for the document under consideration is based on the content of NP-090-11, approved by Order of Rostechnadzor No. 85 dated 07.02.2012.
Also, the grounds for development are the requirements of such regulatory legal acts as:
- Law No. 170-FZ of November 21, 1995;
- Law No. 162-FZ of June 29, 2015;
- Law No. 384-FZ of December 30, 2009
The main development goals are:
- quality control of goods and services;
- control over security at the facility;
- increasing the competitiveness of the enterprise;
- attracting new partners and investors;
- improvement of the general management system and quality control at the enterprise.
In accordance with NP-090-11, there are two types of POC.
The first applies to the work and services performed that can affect the safety state of the nuclear facility at all stages of its operation. Such a program is defined as "General".
The second, "Private", refers to organizations that carry out licensed activities at nuclear facilities and are capable of affecting the safety of such facilities at certain stages of their operation.
Features of the development of a quality assurance program.
Control over the preparation and approval of the program, as well as over the implementation of the measures specified in it and their effectiveness, is carried out both by the operating organizations and directly by the enterprises themselves carrying out economic activities in the field of atomic energy use. This requirement affects both general and proprietary programs.
It is required to develop and agree on the document under consideration before the start of operation of the nuclear facility. It should always be borne in mind that he must take into account the specifics of the use of atomic energy by the enterprise, as well as the norms and rules in force in the Russian Federation.
One program for several facilities, or for several types of activities in the field of atomic energy use, needs to be coordinated as part of the POC formed at the facility.
The revision of the document must be carried out at least once every 5 years, which is explained by the possibility of the future development of the enterprise. As a rule, such development is associated with a change in technology, the list of manufactured products or an expansion of the types of services provided. The clause on the frequency of revision is necessarily included in the content.
Who should be entrusted with the development of POC?
Since the main purpose of this document is to ensure safety at nuclear facilities, accordingly, its development requires a significant amount of work, which is based on a deep analysis of the enterprise documentation, the technology used and the equipment used.
Only highly qualified specialists with extensive experience in performing this type of work are capable of processing such a volume of information, identifying weaknesses in the technological process, indicating the necessary measures to eliminate them and to improve the quality and safety system in the future. Accordingly, in this situation, the best option would be to turn to the services of specialized commercial organizations professionally engaged in the development of this type of documentation for enterprises of various specifics of the use of nuclear energy.
The cost of such a service will be from 60 thousand rubles, and the terms of its provision will take from 5 days. When determining the development time and calculating the cost of work, an individual approach is used in each case. This is explained by the difference in the used methods of using atomic energy, the difference in technological processes and the scale of production activities.
Content requirements.
The content of the considered type of documentation is formed in accordance with the requirements of NP-090-11.
So, as part of the general POC, the scope of its action and the requirements for private POC (if any) are indicated.
For private Programs it is also required to specify:
- scope of distribution (taking into account the specifics of the activity that the action of the generated document covers, and the requirements of the general Program)
- basis for development;
- list of connecting elements (if any);
- list of additional requirements for contractors.
If the enterprise has an approved and functioning quality management system (including international), information about it must be briefly stated as part of the documentation under consideration. Such information includes:
- scope of the quality system;
- list of applied procedures;
- data of the received certificate of conformity with an indication of its validity period.
The first thing that needs to be included in accordance with the requirements of NP-090-11 is information about the enterprise's quality policy.
This section may include data such as:
- scope, which indicates the list of works or services to which the action applies;
- grounds for drawing up;
- requirements for the quality system of contractors involved in work at the facility;
- distribution of responsibility for the organization of individual procedures, processes and activities;
- terms, definitions, symbols used in the formation of the text of the document;
- general provisions on which the object is guided when defining its own quality control structure.
The next section provides data on the adopted personnel management system involved in the performance of work at the nuclear facility. The section provides a rationale for the number of employees involved, a description of the security system, information on the level of qualifications and frequency of certification of specialists, maintaining the relevant documentation and records.
In the section describing the document management system, it is required to highlight:
- list of current procedures;
- the procedure for their accounting, approval, adjustment and storage;
- the procedure for keeping records;
- the list of the applied normative and technical documentation.
- compliance with the requirements of laws and regulations;
- general design process;
- correction of information in project documentation.
In the section on procurement management, the conditions are given, based on which it is made:
- selection of organizations involved in work at the nuclear facility;
- analysis of the documentation of the purchased equipment;
- analysis of the completeness of supervision and testing in relation to the purchased equipment;
- incoming inspection and acceptance of equipment and components.
The mandatory sections of the document under consideration are information about the methodological instructions used at the facility, the metrological and software used.
One of the most important sections is the description of the methods of monitoring the reliability of the elements of the production process and ensuring safety at the nuclear facility.
The last section is devoted to the organization at the object of checks of the effectiveness of the functioning of the implemented system and the effectiveness of the developed measures and procedures.
Agreeing on a quality assurance program.
Information on approval is necessarily reflected in the content of the document. For this, an agreement and approval sheet is included in it. The sheet contains the signatures of the persons carrying out its development, agreement, approval. Signatures are put with a decryption, an indication of the employee's position and the date corresponding to its entry.
The document is agreed only with the customer, it is approved and put into effect in the construction and installation organization before the start of activities at the nuclear facility.
A responsibility.
In case of non-compliance with the rules and regulations established for facilities using atomic energy, administrative liability arises in accordance with Article 9.5 of the Administrative Code.
In accordance with its content, the amount of penalties can range from 200 to 300 thousand rubles in relation to the enterprise itself, and from 20 to 30 thousand rubles for responsible persons, who can also be disqualified for up to one year.
GENERAL QUALITY ASSURANCE PROGRAM
NOVOVORONEZH NPP
POKAS (O)
G 0 QAP 00 XX 00 OR 002
AGREED
| Deputy General Director - production director and nPP operation A.V. Shutikov "___" ______ 201__ | Deputy General directors - branch director Rosenergoatom Concern OJSC "Novovoronezh nuclear power plant" V.P. Chefs "___" ______ 201__ |
| Deputy Director for production and operation of nuclear power plants - director of the Department of Engineering support Yu.P. Teterin "___" ______ 201__ | Director of quality V.N. Blinkov "___" ______ 201__ |
| Deputy General directors - branch director Rosenergoatom Concern OJSC "Management of facilities construction A.V. Palamarchuk "___" ______ 201__ |
FROM
obsession1 Scope 3
3 Terms and definitions 15
4 Abbreviations 15
5 Novovoronezh NPP quality policy 19
6 Organizational activities 21
7 Human Resources 66
8 Document management 111
9 Management of purchases of equipment, components, materials, semi-finished products and software, as well as services provided 141
10 Management of nonconformities 164
11 Audits (checks) 191
Bibliography 233
Schematic diagram of external interactions of Novovoronezh NPP 236
Organizational and functional structure of the branch management
Rosenergoatom Concern JSC Novovoronezh Nuclear Power Plant 237
Pokas (О) 238 change registration sheet
Acquaintance Sheet 239
Application area
This "General Quality Assurance Program for the Novovoronezh NPP" (hereinafter - POCAS (O)) is developed in accordance with the requirements of NP-001, NP-090, STO 1.1.1.01.0678 (OPE AS), STO 1.1.1.04.004.0214, RD EO 1.1 .2.25.1077, current norms and rules in the field of atomic energy use, regulatory documents of Rosenergoatom Concern JSC, as well as taking into account TPRG 1.2.6.9.0091, IAEA safety standards No. GS-R-3 "Safety requirements" and requirements standard GOST ISO 9001-2011.
This POKAS (O) applies to the NF listed in clause 1.4, which, while not being separate (from the Novovoronezh NPP) facilities, are part of the structures and complexes of the Novovoronezh NPP. At the same time, the descriptions of the procedures and order, organizational, technical and other measures for quality assurance, given in the relevant sections of this quality assurance program, are equally aimed at the implementation of the established criteria and safety principles of all the listed NF of Novovoronezh NPP at all stages of their life cycle.
The POCAS (O) provisions apply to all areas and activities of the operating organization and organizations that perform work and provide services to the operating organization that affect safety at all stages of the life cycle of nuclear facilities (hereinafter - NF) of the Novovoronezh NPP.
The NF of Novovoronezh NPP, the activities of which are subject to licensing, include:
excluded
excluded
nuclear installation of power unit No. 3 (under operation);
nuclear installation of power unit No. 4 (under operation);
nuclear installation of power unit No. 5 (under operation);
nuclear installation of power unit No. 1 of NPP-2 (at the stage of commissioning);
nuclear installation of power unit No. 2 of NPP-2 (under construction);
a nuclear material storage facility - a stand-alone spent fuel storage facility (OSHOT) (under operation);
storage of fresh nuclear fuel (KST) of power units No. 1, 2 of NPP-2;
storage of solid radioactive waste for temporary storage of 10,000 containers with radioactive waste (SRW) (at the stage of commissioning);
excluded
radioactive substances (non-nuclear materials, substances that emit ionizing radiation);
radioactive waste (radioactive substances, the use of which is not provided);
new nuclear facilities under construction (nuclear material storage, radioactive substances, radioactive sources and radioactive waste).
POKAS (O) covers the following stages of the life cycle of the nuclear facility of the Novovoronezh NPP:
design;
construction;
operation;
removal from service;
design of equipment for nuclear installations of power units;
manufacturing of equipment for nuclear installations of power units;
handling of radioactive substances during their transportation;
handling radioactive waste during transportation.
POKAS (O) determines the policy of the operating organization and the management of Novovoronezh NPP in the field of quality assurance, organizational, technical and other quality assurance measures aimed at implementing the established criteria and principles for ensuring the safety of nuclear facilities at Novovoronezh NPP at all stages of their life cycle.
POKAS (O) establishes requirements for private quality assurance programs for activities at the stages of the life cycle specified in clause 1.5. These requirements should also apply to the activities of suppliers (contractors) and subsuppliers (subcontractors) of products, works, services when performing certain types of work at these stages (design support for construction, construction and installation work, installation, adjustment, training, repair, etc.) ...
This POKAS (O) is part of a set of documents justifying nuclear and radiation safety, submitted to the Federal Service for Environmental, Technological and Nuclear Supervision to obtain licenses for the right to carry out activities in the field of atomic energy use in the cases provided for Administrative regulations for the provision of state services for licensing activities in the field of atomic energy use by the Federal Service for Environmental, Technological and Nuclear Supervision.
Knowledge and implementation of the provisions of this POCAS (O) (after its entry into force) is mandatory for employees of the central office Rosenergoatom Concern JSC and Novovoronezh NPP in the scope of their job duties established by the relevant job descriptions, and employees of contractors in the scope of the relevant agreements (contracts).
The management of Novovoronezh NPP ensures that POKAS (O) is available for review to any NPP employee, as well as provides it to contractors whose work (services) must comply with the provisions of POKAS (O).
The operating organization organizes the development, approval, commissioning, implementation, verification of implementation and assessment of the effectiveness of the implementation of POCAS (O).
POKAS (O) is put into effect by the order for the Novovoronezh NPP on the basis of the order of the operating organization and is subject to revision periodically, once every 5 years. Changes to POCAS (O) are made based on the results of external and internal inspections (audits), when the organizational and functional structure of the nuclear power plant management changes, when new ones are introduced and when the requirements of the current regulatory documents change, and taking into account the accumulated experience of NPP operation in accordance with STO 1.1 .1.01.003.0859 and the procedure established by Rostechnadzor.
The implementation of POCAS (O) and private quality assurance programs is based on the following principles:
the quality policy is an element of the operating organization's unified technical policy at the stages of the nuclear facility's life cycle, implemented by the Novovoronezh NPP, and is approved by its top management as part of this POCAS (O);
quality management is an aspect of the overall function of the organizational management structure;
the quality system is periodically reviewed by the management of Novovoronezh NPP to ensure that it consistently meets the necessary requirements and is effective;
responsibility for quality assurance when performing a specific work or service is assigned to the performers, and not to those who check the quality of its performance;
a clear delineation of responsibilities between all performers of work at all stages of the nuclear facility's life cycle, including the construction of new facilities of the Novovoronezh NPP, on the quality of the results of these works is ensured;
quality control of activities at all stages of the nuclear facility life cycle and revisions of the quality system are carried out by competent persons or groups of persons who are not directly responsible for the audited areas, did not participate in the audited work and are not administratively dependent on the audited entity;
the quality system should operate in such a way as to provide confidence that problems are prevented rather than detected once they occur;
quality assurance methods take into account the classification of equipment, systems and structures established by the norms and rules in the field of the use of atomic energy in terms of the impact on the safety of the Novovoronezh NPP;
works affecting the safety and quality of activities at all stages of the life cycle of the nuclear facility of the Novovoronezh NPP are performed according to documented procedures;
POKAS (O) reflects the structure of interaction between organizations participating in the operation of existing and construction of new nuclear facilities at the Novovoronezh NPP, within which quality assurance work is planned and carried out;
compliance with regulatory requirements is regularly monitored and the results of this control are clearly documented;
systematic control of changes in all current documentation is carried out in accordance with the established procedure.
Quality assurance activities are planned and implemented at Novovoronezh NPP on the basis of annual, quarterly and current schedules for the types of activities, approved in the prescribed manner.
For each product or process, the organization must implement quality programs,interrelated with all other requirements of the organization's quality system and ensuring that specific requirements for a product, project or contract are met.
Quality program- a document regulating specific quality measures, resources and the sequence of activities related to a specific product, project or contract.
When creating a quality system at an enterprise, one of the main points is the development and adjustment of specific regulatory documents, which should outline the methods for performing functions and tasks in the quality system. At the same time, it is necessary to adapt the specific ISO recommendations to real conditions so as not to harm production, but to streamline and systematize the methods and documents used for quality management in accordance with the list of elements recommended by ISO. To create and adjust regulatory documents, the quality management department must draw up and approve with the management an appropriate schedule with an indication of specific performers and terms of work. Possible duplication of documents developed by different performers should be excluded, and the omission of documents necessary for the performance of certain functions should be prevented, all work should be carefully coordinated and debugged.
For the final formation of the quality system documentation, the creation of a generalizing document is required, in which a general description of the quality system should be presented. This description is provided by ISO 9000 standards in the form Quality manuals.The quality manual can be presented to customers when concluding contracts, to independent experts when checking the quality system in order to certify it. Guidance on the development of a quality manual is provided in ISO 10013, Guidelines for the development of a quality manual.
The Quality Manual should contain the following information:
■ a brief description of the enterprise and its products;
■ structure of the quality system;
■ structure and functions of the quality service;
■ scope and status of the Guidelines;
■ the company's quality policy;
■ distribution of functions, responsibilities and authorities of top managers in the field of quality;
■ functions and elements of the quality system with an indication of the performers and a summary of the methods of their implementation.
The description of the constituent elements of the Quality Manual should preferably be given in the same sequence in which they are set out in the ISO 9001, 9002, 9003-1994 standards or in the ISO 9001-2000 standard. This will facilitate the work when presenting the quality system to customers, and also for auditors when certifying a system for compliance with ISO 9000 standards. If, due to the nature of the enterprise, it is impossible to follow the sequence of elements in ISO 9000 in the Quality Manual, it is recommended to submit a transition table indicating the correspondence of the element numbers of the ISO standard and the Quality Manual. As an illustrative material, the Guide should provide a structural diagram of the quality system. If the organization has developed a functional diagram, it is also advisable to include it in the Manual, which will help to show not only the "device", but also the "operation" of the quality system. After completing the listed steps, it can be considered that the quality system has been developed and the recommendations of the ISO 9000 standards are taken into account.
It must be remembered that the solution to quality problems will depend not only on how the quality system is developed, but also on how it functions, that is, how the functions and tasks of the system are carried out in practice by all its participants: from management to an ordinary performer.
Position
on the development of quality assurance programs in the design and construction of products supplied to nuclear facilities
I. Purpose and scope
1. The Regulation on the development of quality assurance programs in the design and construction of products supplied to nuclear facilities (hereinafter - the Regulation) is included in the number of regulations on the safety regulation of nuclear facilities (safety guidelines), is advisory in nature and is not a regulatory legal act.
This Regulation contains recommendations for the development of quality assurance programs (hereinafter referred to as QAP) in the design (construction) of systems (elements) affecting the safety of nuclear facilities (hereinafter referred to as NF), and in the development of equipment included in these systems (elements) ( further - product development).
2. This Regulation defines the approaches to the implementation of the requirements of federal norms and rules in the field of atomic energy use to the POC when performing design, engineering and design work (hereinafter referred to as RCC) in the process of developing products supplied to NF (including the development of nuclear fuel) namely:
1) NP-011-99. Requirements for quality assurance programs for nuclear power plants. Approved by the Resolution of Gosatomnadzor of Russia dated December 21, 1999 No. 4;
2). NP-041-02. Requirements for a quality assurance program for nuclear fuel cycle facilities. Approved by the Resolution of the Gosatomnadzor of Russia dated December 31, 2002 No. 15;
3) NP-042-02. Requirements for a quality assurance program for nuclear research facilities. Approved by the Resolution of the Gosatomnadzor of Russia dated December 31, 2002 No. 16;
4) NP-056-04. Requirements for the quality assurance program for nuclear power plants of ships. Approved by the Resolution of the Federal Service for Environmental, Technological and Nuclear Supervision of December 31, 2004 No. 13.
3. For the development of the QAP when performing the RCC in the process of developing products supplied to the NF, other approaches can be used if they are sufficiently substantiated.
II. General Provisions
4. The QAP in the development of products establishes organizational and technical measures to ensure the quality of products aimed at the safety of nuclear facilities, and is developed in order to ensure confidence from the customer, other interested organizations and supervisory authorities that the CRP performed during the development of products supplied to the nuclear facility , as well as their results (design, design and other technical documentation, manufactured prototypes of the product) meet the requirements established in technical regulations, federal norms and rules in the field of atomic energy use, technical specifications (hereinafter referred to as TOR) for the implementation of anti-ship missiles or product development , initial requirements of the customer or initial technical requirements (hereinafter referred to as ITT), the contract for the implementation of the RCC, the general quality assurance program for nuclear facilities, design, engineering, technological, operational documentation developed in relation to nuclear facilities, guidelines, standards and other norms active technical documents (hereinafter - NTD).
5. The organization performing the RQD develops, approves and coordinates the QAP prior to the start of the work regulated in the program.
6) the terms used and their definitions (if necessary).
7. For each area of \u200b\u200bactivity listed in the QAP, it is recommended to indicate the distribution of responsibility of the management and personnel of the organization, as well as the documents (procedures) used in the development and implementation of measures in this area.
1) a significant change in the requirements for the QAP or requirements affecting the safety of nuclear facilities and / or the quality of anti-ship missiles;
2) changes in the organizational structure or boundaries of responsibility of divisions and organizations;
3) changes in the order of execution of the RCC;
4) the presence of significant comments or inconsistencies identified in the process of internal and external inspections (audits) of the QAP.
9. In the event that deficiencies in the QAP (including its lack of effectiveness) are found, the organization responsible for the development and implementation of this program takes measures to eliminate them in the QAP and (or) in the work of the organization.
10. For newly developed products, it is allowed to use the standard quality assurance programs in force in the organization, provided that they take into account the specifics of the requirements for these products and satisfy the quality assurance requirements established by the customer.
11. The section "Quality policy" provides a quality policy for the organization's activities, which:
1) purpose (purpose), scope (application) of the QAP;
2) a list of scientific and technical documentation, in accordance with which the QAP was developed (a link to the appendix to the QAP is allowed);
3) information about the general quality assurance program (if any), within the framework of which the QAP was developed;
4) the procedure and frequency of analysis and revision of the QAP.
13. In the section "Organizational activities for quality assurance" it is recommended to provide:
1) a list of basic documents that determine the organizational and legal form of the organization;
2) information about the field of activity of the organization, defined in its Charter;
3) information on the organization's licenses of the Federal Service for Environmental, Technological and Nuclear Supervision (hereinafter - Rostekhnadzor) for the right to work in a certain area of \u200b\u200batomic energy use and licenses of other federal executive authorities (at the time of the completion of the development of the POC);
4) information on the distribution of responsibility for the implementation of activities in the field of quality between the organizations involved in the development of the product and the operating organization of the nuclear facility;
5) a brief description of the quality management system (hereinafter - QMS) of the organization (indicating the main documents and certificates of conformity, if any).
1) the basic principles of quality management on which the organization's activities are based;
2) the organizational structure of the organization in the part related to the implementation of the QAP (indicating the representative of the organization's management and departments responsible for the quality of the quality control, technological, inspection control, metrological supervision and control, author support, quality management);
3) functional duties, powers and boundaries of responsibility, the procedure for interaction of officials, leading RPC, performing and evaluating RPC (it is recommended to exclude duplication of subordination and duplication of execution);
4) powers and boundaries of division of responsibility for work performed by contractors within the framework of the QAP;
5) the main functions of the personnel of the organization and its subdivisions in the development and implementation of the policy in the field of quality, QAP, quality assurance and control of the QRC and prototypes of products;
6) a brief description of the procedure for quality management activities, including its planning, implementation, control, analysis, evaluation and improvement.
13.2. It is recommended to formulate the principles of quality management in the implementation of the IDC taking into account the following provisions:
1) quality assurance activities are carried out on the basis of a differentiated approach based on the classification of products and the work performed on their impact on the safety of nuclear facilities (taking into account the potential danger of products of inadequate quality and reliability during their operation);
2) technical and organizational decisions taken during the implementation of anti-ship missiles to ensure the safety of nuclear facilities comply with the requirements of scientific and technical documentation and are justified by calculations, research, testing, approbation, previous experience in performing similar work and experience in operating similar products, as well as analysis of the achieved level of science and technology;
3) when the requirements of the existing ones change and new regulatory and technical documents are introduced, the analysis of the impact on safety of the identified deviations from the new requirements is carried out, the development and implementation of measures to eliminate and / or compensate for the impact of deviations on the safety of nuclear facilities;
4) changes in the organizational structure in order to exclude their possible negative impact on the quality of the implementation of the RCC are justified in advance, carefully planned and evaluated after their implementation by the management of the organization;
5) between the managers, performers of work and employees exercising control over the performance of work, a delineation of powers and duties is established, excluding their duplication, while the responsibility for the high-quality performance of a specific work lies with the direct performers;
6) responsibility for the implementation of the QAP lies with the management of the organization.
13.3. If necessary, the section provides requirements for the QAP of contractors involved in the implementation of the RCC, which are additional to the requirements established by federal rules and regulations in the field of atomic energy use and (or) the general quality assurance program for nuclear facilities.
14. The section "Personnel management" describes the current organization system for the selection, training and maintenance of personnel. It is recommended to provide information:
1) on measures to ensure staffing and professional competence at a level sufficient for the high-quality performance of the PKR in a timely manner;
2) on the availability of requirements for personnel performing work affecting the quality of the RCC, directly exercising quality control of the RCC, testing and inspection (including data on the most important qualifications, the type and duration of training in relation to specific job responsibilities, the amount of knowledge and practical experience and etc.);
3) on the development, implementation and analysis of programs for training, retraining, advanced training, certification and verification of personnel knowledge, ensuring the study of federal norms and rules in the field of atomic energy use, safety requirements for nuclear facilities and the quality of the RCC performed in accordance with the job duties of employees ( including when new NTDs are put into effect and existing documents are changed);
4) on the procedure for maintaining accounting records for personnel management (including training schedules, attendance logs, knowledge test certificates, etc.);
5) on the activities of the administration of the organization for the formation and maintenance of a safety culture, the awareness of each employee of the organization of personal involvement in quality assurance issues;
6) on the procedure for quality control and assessment of the effectiveness of activities related to the selection, training and maintenance of the qualifications of the organization's personnel.
15. The section "Document Management" describes the organization's system for managing documents used in the implementation of the RPC.
a) applies to all types of documentation used in the implementation of the PKR (including normative, technical, regulatory, methodological, organizational, project, design, technological, software, executive, reporting, delivery, etc.);
b) based on a unified procedure for handling documents, including the development, identification and elimination of inconsistencies, approval, coordination, commissioning, replication, classification, identification, inventory, registration, revision, distribution, storage, destruction of documents;
c) is aimed at:
ensuring the completeness, reliability, consistency and validity of the documents used;
exclusion of the use of outdated and canceled documents;
timely detection of inconsistencies and making necessary changes;
provision of workplaces with valid documents.
a) application of documents in the event that they do not contradict the requirements of technical regulations, federal norms and rules in the field of atomic energy use and other documentation;
b) checking the availability of the necessary valid documents at the site of the RPC before the start of these works, in accordance with the requirements of which technical and organizational decisions are made;
c) control of registration records, duplication, distribution, withdrawal, destruction, storage of documents;
d) timely cancellation of documents whose validity is suspended (including separate storage of canceled or replaced documents);
e) execution of documents on a data carrier that guarantees their readability and safety;
f) identification and preservation of documents reflecting the main stages of the implementation of the RPC (including sources justifying the adoption of final decisions), as well as changes and additions to them within a specified period.
16. The section "Management of the supply of equipment, components, materials, as well as the services provided" describes the procedure for performing activities carried out in order to ensure compliance with the established requirements of equipment, components and materials used in the manufacture of prototype or prototypes of products, as well as services (works) provided (performed) by contractors.
a) checking whether the organization has a Rostekhnadzor license for the right to perform the relevant work (provide services) - if necessary;
b) analysis of consumer experience of identical (or similar) products or services performed by the intended supplier; operating experience of the intended supplier's products; the available data related to the purchased products or provided services, which are representative characteristics of the current ability of the prospective supplier to ensure the quality of the products used or the services provided (work performed) in accordance with the requirements of the NTD and the delivery documentation on time with appropriate economic efficiency;
c) conducting, if necessary, an audit of the supplier's QMS in relation to the services provided (work performed) and (or) the manufacture of the products used.
2) The section describes the procedure for checking the products used (before their use) for compliance with the requirements established in the NTD, and the requirements for delivery, which are provided:
a) verification of the fulfillment of the conditions for preparation, consideration, coordination and approval of delivery documents, including verification of the availability of certificates of conformity (including, if necessary, in the Certification System of equipment, products and technologies for nuclear installations, radiation sources and storage points);
b) analysis of the existence of established requirements for the quality of the products used and the possibility of their verification; requirements for labeling, preservation, packaging, loading, transportation, unloading, storage conditions, re-preservation; requirements for personnel performing work related to the products used, etc .;
c) control of compliance of product quality data received from the supplier with the established requirements;
d) carrying out control operations (tests);
e) corrective and preventive measures (including in terms of handling non-conforming products) and assessment of their effectiveness (efficiency).
17. The section "Production activity" describes the procedure for performing the RCC at all stages of product development, including:
1) development of technical specifications (ITT) for products;
2) the stages of development of technical documentation (for example, the development of design documentation in the general case provides for the stages of a technical proposal, draft design, technical design, development of working documentation);
3) development and testing of manufacturing technology and equipment for the manufacture of prototypes of the product, organization of production, production of prototypes of the product and testing (control) thereof;
4) acceptance of the results of the RCC.
1) development, coordination and approval of the TOR (ITT), which establishes the stages and stages of development, requirements for the parameters and characteristics of the product (including the requirements for the quality and reliability of products, taking into account their impact on the safety of nuclear facilities);
2) assessing the technical level of the products being developed for compliance with the world level (at the stage of developing the technical specification (ITT) before its approval);
3) distribution of responsibility for the development and control of technical documentation with the establishment of boundaries for the implementation of the RCC and interactions between the organization's divisions and contractors;
4) preparation of contract documents, plans and schedules for the development of technical documentation, development requirements; issuing assignments to contractors and departments;
5) control of compliance of the developed technical documentation with the requirements of technical regulations, federal norms and rules in the field of atomic energy use, TK (ITT), standards of the Unified System for Design Documentation, the Unified System for Technological Documentation and the Unified System of Program Documentation, design specifications, drawings, instructions, etc. .;
6) production and testing of prototypes and prototypes of products that are planned to be delivered to the nuclear facility after testing, in accordance with quality plans.
17.2. It is recommended to indicate in the section that when performing RCC related to the development of products used at NF in the management of radioactive waste (hereinafter - RW), measures are developed to ensure, during operation and decommissioning of these products:
1) prevention of unplanned accumulation of radioactive waste;
2) limiting the formation of radioactive waste at the minimum practically achievable level;
3) organization of quality control of carrying out technological processes in RW management.
1) functional and performance requirements applicable to the product;
2) relevant legal and other mandatory requirements;
3) information taken from the experience of previous development, manufacture and operation of similar products;
4) other requirements affecting the safety of nuclear facilities and the quality of products.
1) the analysis of the input data for the implementation of the RCC and the identification of the most effective solutions for their implementation can be carried out based on the results of the previously completed research and development work, and the form of submission of the input data, their content and submission deadlines are stipulated in the contract for the implementation of the RCC.
2) the output data of the completed RCC:
a) are documented in the form of technical documentation containing, in the general case, a graphic part, text documentation, calculations, test reports, justifications, conclusions of manufacturers, an operating organization, etc.;
b) meet the input data (requirements) of the development or exceed them;
d) provide relevant information on the activities for the manufacture and operation of the product;
e) identify the parameters and characteristics of the product that affect its quality and reliability;
f) are traceable, i.e. confirmed by the control of the completed RCC and tests at various stages and stages of the RCC in order to make sure that the parameters and characteristics of the product comply with the established requirements in the TK (ITT) and other documents (protocols, acts, etc.);
g) are verified against input data and validated prior to their subsequent use.
17.5. It is recommended to describe the current procedures for monitoring compliance with the requirements of TK, technical regulations, federal norms and rules in the field of atomic energy use, and procedures confirming the correctness of the adopted technical solutions in the process of technical control, regulatory control, metrological supervision and control and supervision, testing. , author's support, as well as control carried out by the customer and other organizations (in the process of external control). It is recommended to indicate the following:
1) technical control is carried out at the control points predetermined in the TOR (ITT) and (or) plans of the RPC, depending on the stage or stage of the RPC and provides for checking the completeness, reliability and validity of the information provided, including:
a) analysis of the compliance of the documents being checked, included in the PKD, with the requirements of the TK (ITT) and NTD;
b) an assessment of the adopted design solutions for scientific and technical indicators, including an analysis of the compliance of design solutions with the performed calculations, analysis of the correctness of the calculations (for example, by comparing their results with the results obtained using alternative methods of calculation, testing, modeling), comparing the new project with a similar project, tested in practice, if such exists; analysis of the correctness of the choice of equipment, semi-finished products, components and materials;
c) analysis of the correctness of compliance with the specifications related to the checked document; indication of sizes, parameters, projections, sections, sections, types, selected materials, sheet layout, scale selection, graphic execution of drawings and diagrams), etc.;
d) analysis of the correctness of the application of regulatory, accounting documents;
2) in the process of standard control, they check the compliance of the developed technical documentation with the requirements of the current scientific and technical documentation;
3) metrological expertise provides for the analysis and assessment of technical and organizational solutions related to the selection of measured parameters, the establishment of requirements for the accuracy of measurements, the choice of methods and measuring instruments and their metrological maintenance, the development of control procedures, measurements, processing of their results, etc .;
5) external control (examination) of the completed RCC is carried out by the customer, the operating organization, higher organizations, specialized expert organizations in accordance with the procedure established by them.
17.6. It is recommended in the section to indicate the requirements for officials involved in the control of the developed technical documentation, taking into account the fact that they are not directly involved in the development of the audited documentation, their qualifications are not lower than the qualifications of performers and they have experience in performing similar ICPs. At the same time, technical control is carried out in the departments that develop the documentation by specialists appointed by the management; all other types of control, as a rule, are carried out in specialized units or contractors.
17.7. It is recommended to indicate in the section that as a result of RCC control, areas of possible occurrence of problems and inconsistencies are identified and predicted, and corrective actions are taken and measures are developed to prevent their occurrence in the future and ensure that the final RCC results meet the customer's requirements.
1) at the stage of the technical design - the protection of the results of the RPC performed at the scientific and technical council of the organization or the customer with the participation of the manufacturer's representatives (if necessary);
2) upon completion of the RPC - consideration of the RPC results by the acceptance committee, during which the results of the work performed are checked for compliance with the requirements of NTD, TK (ITT), an assessment of the scientific and technical level of the adopted technical solutions, their validity and a decision on the expediency of using the results creation of working documentation.
1) conducting acceptance tests and analyzing their results;
2) consideration of the developed technical documents;
3) drawing up and approval of an act, which indicates the compliance of the developed products with the requirements of technical specifications (TK, ITT) and the possibility of their manufacture;
4) analysis of the results of assessing the technical level, manufacturability, competitiveness and quality of products (including indicators of product reliability in storage and operation);
5) analysis of the results of the assessment of the developed technical documentation, etc.
1) registration of notices of changes, permits to make changes to the developed technical documentation;
2) coordination of changes in technical documentation with the customer, regulatory and supervisory bodies, organizations and departments that previously agreed on these documents;
3) amendments to the technical documentation for systems (elements) important to the safety of the nuclear facility, in accordance with the requirements of Rostechnadzor, which establish the main provisions for the preparation, consideration and decision-making on changes in the design and design documentation affecting the nuclear and radiation safety of the nuclear facility;
4) analysis of the need to correct other documents related to the changed documentation, and control of these changes;
5) making a decision on the advisability of reprinting the documentation in the presence of a large number of changes made to it;
7) control of receipt of modified documentation by addressees and removal of outdated versions.
18. In the "Tests" section, information is provided on the procedure for conducting, monitoring the purpose and results of tests, as well as the procedure for their validation (if tests are planned when performing the RCC).
1) laboratory research, bench and other tests of models, mock-ups, full-scale components of the product, as well as fine-tuning tests of experimental and prototypes in conditions simulating real operating conditions, during which new technical solutions are selected, tested and tested to ensure the achievement of the main operational product characteristics;
2) control tests of prototypes (pilot batch, prototypes) of the product, which include:
a) preliminary tests carried out for the purpose of preliminary assessment of the compliance of the prototype product with the requirements of the TK (ITT), adjusting the PKD, and also to determine the readiness of the prototype for acceptance tests;
b) acceptance tests conducted in order to assess the compliance of all product characteristics with the requirements established in the TK (ITT); verification and confirmation of the compliance of the prototype product with the requirements of the TOR (ITT) in conditions as close as possible to the conditions of the actual operation of the product, as well as for making decisions on the possibility of manufacturing and delivering the product to the nuclear facility.
c) reliability tests, carried out in order to assess the compliance of the product reliability indicators with the requirements established in the technical specification (ITT).
1) the completeness of the composition of the types of tests provided for verification of the results of anti-ship missiles;
2) the reliability and acceptability of the test results obtained;
3) availability of approved and agreed programs and test methods;
4) the readiness of the test equipment to ensure the specified technical characteristics of products and their control (including requirements for safety and reliability);
5) compliance of the material, technical and metrological support with the requirements guaranteeing the creation of conditions and test modes specified in the program and test methods, ensuring the receipt of reliable results;
6) fulfillment of the requirements for the timing of testing, for the qualifications and experience of personnel admitted to testing;
7) information on how the product operation model, requirements for metrological support, conditions for the acceptability of test results, representativeness of tests in terms of volume and composition of products are reflected in the programs and test methods;
8) the possibility of using the results of acceptance tests in assessing the conformity of a product (including when carrying out its mandatory certification in the Certification System for equipment, products and technologies for nuclear installations, radiation sources and storage facilities);
9) the correctness of documenting test results and assessing their acceptability (reliability).
18.3. It is recommended to indicate in the section that if, as a result of testing, it is established that the parameters or characteristics of the product do not correspond to the specified requirements, it is planned to analyze the consequences of the identified deviations (inconsistencies), taking into account their impact on the safety of nuclear facilities, develop the necessary corrective measures and evaluate their effectiveness.
19. The section "Metrological support" describes the procedure for carrying out activities aimed at establishing and applying scientific and organizational foundations, technical means, rules and norms necessary to achieve unity, the required accuracy and reliability of measurements.
As part of the activities on metrological assurance, it is recommended in the section to indicate the need to perform and control the following measures based on unconditional compliance with the requirements of the documents of the state system for ensuring the uniformity of measurements:
1) carrying out a metrological examination of the developed technical documentation;
2) development and approval of nomenclature lists of the main parameters of the product to be measured, as well as lists of measuring instruments, control and test equipment used when performing RCC (indicating their accuracy class, measurement procedures, etc.);
3) purchase, manufacture, identification, accounting, storage, operation (including maintenance and repair), write-off of measuring instruments, control and test equipment;
4) calibration and verification of measuring instruments, certification of test equipment and procedures, verification of control equipment in accordance with established procedures and developed lists and schedules;
5) maintaining, recording and storing the protocols of documentation on metrological support;
6) metrological supervision of divisions and contractors that use measuring instruments, control and test equipment.
20. In the section "Quality assurance of software and calculation methods" describes the procedure for the implementation of activities to ensure the quality of software (hereinafter - PS) and calculation methods, including:
1) the organization of interaction between the divisions of the organization in terms of preparing data for carrying out calculation work;
2) the organization of the development of PS and calculation methods, the use of PS and calculation methods developed by third-party enterprises;
3) the use of licensed software systems developed by third-party enterprises;
4) registration, verification and attestation of PS and calculation methods.
It is recommended in this section to provide a list of PS and calculation methods used in the implementation of the RPC, indicating the area of \u200b\u200btheir application and information on registration, verification and certification of PS in the manner established by Rostechnadzor.
21. The section "Ensuring reliability" describes the procedure for carrying out activities aimed at ensuring, confirming and monitoring compliance with the established requirements of the reliability indicators of the products being developed.
As part of the activities to ensure reliability, it is recommended to carry out:
1) selection of the nomenclature and standardization of reliability indicators of the product and its elements, taking into account possible options for circuit design, product features, modes and conditions of its operation, reliability indicators of the best domestic and foreign analogues;
2) analysis of the types of possible failures and the severity of their consequences, establishment of failure criteria and limiting state criteria, calculation of reliability indicators for critical failures or for the entire set of possible failures, selection of the most reliable option;
3) development and justification of requirements for the reliability of product elements;
4) selection of structural materials and elements, taking into account the requirements for the reliability of elements and the product as a whole;
5) development of organizational and technical solutions and measures to ensure the required durability and performance of products under specified conditions (including external influencing factors), modes and time of operation;
6) development (selection) of methods and means for monitoring technical condition (diagnostics);
7) selection of methods for monitoring reliability indicators;
8) an updated design estimate (forecasting) of the reliability indicators of the product as a whole and its elements;
9) development of programs and methods for testing the reliability of a prototype product (batch of products) or head product;
10) experimental development and reliability testing of prototypes, elements and products as a whole;
11) analysis of the causes of failures and damages of prototypes, development of measures to eliminate them;
12) analysis of the developed operating rules, operational and repair documentation on the frequency and volume of planned maintenance and repair of products to maintain and restore the specified reliability requirements;
13) selection of the required nomenclature and strategy for replenishing the set of spare parts and tools during the operation period;
14) selection and justification of a system for collecting and processing information about the reliability of products and their elements at various stages of the life cycle;
15) development of requirements for manufacturing technology, analysis of the proposed manufacturing technology in terms of ensuring the quality of elements that are critical in ensuring the reliability of products;
16) development (if necessary) of methodological, technical and instructive documents on reliability assurance.
It is recommended to provide information on the functioning of the feedback system between the operating organization of the nuclear facility and the organization developing the product in order to obtain information on the operability and failures of previously designed similar products (and their elements) operated at the nuclear facility.
22. The section "Control of nonconformities" describes the procedure for performing activities aimed at timely identification and elimination of inconsistencies associated with violation of the requirements set in the NTD or deviations from them, which lead to a decrease in the quality of GZhR or products performed.
1) the source of data on nonconformities are the results of tests of elements, prototypes of products, products of the first industrial batch, the results of inspections, QAP checks, incoming quality control of materials, components, results of control of works (services), technological processes, etc.;
2) analysis of the impact of the identified inconsistencies on safety, provides for the identification of direct and root causes of inconsistencies, their systematization and ranking, identification of significant factors that negatively affect the quality of work;
3) the exclusion of the possibility of using (including accidental) materials and products, as well as performing work that does not meet the established requirements is ensured;
4) the management of the corresponding level is notified in accordance with the established procedure about inconsistencies and about emerging trends in the causes and nature of violations and deviations from the requirements of the NTD (at the same time, Rostechnadzor and other supervisory authorities are informed about inconsistencies affecting the safety of nuclear facilities, the correction of which is possible only with the adoption of special decisions requiring changes to the design, construction documentation or NTD, as well as when work is stopped according to the orders of the supervisory authorities).
1) change in the organization of quality control of work performance;
2) revision (change) or release of new documents;
3) improvement of the administrative control procedure, elimination of management deficiencies, distribution of responsibilities of personnel to carry out corrective and preventive measures;
4) advanced training of performers (including retraining and re-certification of personnel responsible for the emergence of conditions that adversely affect the quality of RCC);
5) increased responsibility for non-fulfillment (improper fulfillment) of official duties;
6) replacement of the contractor;
7) replacement or improvement of defective products;
8) control over the effectiveness (efficiency) of the taken corrective and preventive measures;
9) ensuring the documentation and communication of the results of the analysis of the causes of inconsistencies and the corrective and preventive measures taken to the management of the appropriate level and performers.
22.3. The input data for the development of corrective and preventive measures are information from the operating organization of the nuclear facility; the results of self-examination by the personnel of the work performed, technical and technological control, metrological examination, standard control, inspections, tests, checks of the POC, author's support for the manufacture and operation of previously developed similar products; information materials about inconsistencies at nuclear facilities, etc.
23. The section "Quality Records Management" describes the procedure for the implementation of activities aimed at the formation and maintenance of documentation, which reflects information on the quality of the performance of the RCC (including the results of audits, inspections, tests, analyzes, reports on nonconformities, instructions for elimination inconsistencies, certificates of conformity, passports for materials, products, etc.).
1) establishing the type of quality records, depending on their importance, and their identification on the basis of systematic accounting and registration of information carriers;
2) ensuring the completeness and timeliness of the submission of information on quality on the basis of the current system for collecting, registering, providing access, compiling a file cabinet, storing, maintaining, transferring data and destroying the registered expired quality documentation;
3) ensuring the necessary conditions for the long-term storage of records in the appropriate premises, in conditions precluding their damage and loss;
4) the use of only valid records at workplaces (when the canceled or replaced documentation is promptly returned to the archive and appropriately marked in order to prevent its accidental use);
5) establishment of frequency and forms of reporting on quality;
6) prompt transfer of information about decisions made to executors;
7) collection and analysis of information on the implementation of the decisions taken;
8) preparation of reports containing the results of inspections carried out on the use of documents, the quality of technical documentation (including information on interrelated changes in the QMS and QMS documents), etc.
24. The section "QAP Checks" describes the procedure for conducting inspections (audits) of the organization's QAP and private QAP of contractors in all areas of activity described in these programs.
1) for a systematic assessment of the effectiveness (efficiency) of the QAP, assessing the effectiveness of management of the organization's activities and the performance by its personnel of official duties;
2) after making significant changes to the QAP and (or) if a revision of the QAP is required;
4) if necessary, control the implementation of corrective and preventive measures;
5) to assess the activities of the contractor before concluding an agreement (contract) for the supply of materials, products and the provision of services (performance of work);
6) after the conclusion of the contract to check the fulfillment by the contractor of obligations and requirements in accordance with the contract and NTD.
1) the organization conducts internal checks of the QAP in its divisions and external checks of private QAP in accordance with the developed procedure;
2) external audits of the implementation of the QAP are carried out by higher organizations and operating organizations in accordance with the procedure established by them;
3) a planned QAP check is carried out in accordance with the schedule of QAP compliance audits, approved by the management of the auditing organization;
4) an unscheduled QAP check is carried out in cases of revealing a trend towards a decrease in the quality of the RCC performed and their results, as well as, if necessary, checking the implementation of planned corrective and preventive measures and assessing their effectiveness (effectiveness).
24.3. As part of activities related to QAP audits, it is recommended to provide for the implementation of measures to ensure, among other things:
1) appointment of an inspection commission with appropriately selected, trained and certified personnel who are not directly responsible for the performance of the work being inspected;
2) development of the QAP check plan by the checking commission;
3) advance notification of the management of the audited organization (subdivision) about the scope and timing of the QAP audit (in case of unscheduled audits, it is allowed to conduct an audit without prior notice);
4) consideration of the results of the QAP check at a meeting of the checking commission with the participation of the management of the audited organization (division);
5) development and implementation of a plan of corrective and preventive measures, providing, if necessary, adjusting the QAP, as well as submitting a report on its implementation;
6) documenting by the inspection commission of the results of audits of the implementation of the QAP in the form of a report containing proposals for eliminating the identified inconsistencies and assessing the effectiveness (efficiency) of corrective and preventive measures taken based on the results of the previous audit.
