Standard No.:	HAF.J0045-1994
English Name:	Technical Documents for Nuclear Safety Regulations - A Manual on Quality Assurance Grading
Chinese Name:	核安全法规技术文件 质量保证分级手册
Professional Classification:	HAD    Professional Standard - Nuclear Power
Issued on:	1994-11-07
Implemented on:	1994-11-7
Status:	valid
Target Language:	English
File Format:	PDF
Word Count:	12000 words
Translation Price(USD):	1200.0
Delivery:	via email in 1 business day

Since its establishment in October 1984, the National Nuclear Safety Administration has successively issued a number of nuclear safety regulations (rules, provisions and implementation rules) and guidelines. Nuclear safety regulations are mandatory legal documents. The nuclear safety guidelines are guidance documents, for describing and supplementing the regulations. Nuclear safety regulations and guidelines stipulate the nuclear safety supervision and management system, and put forward the basic requirements of nuclear safety and the recommended methods and procedures, but more specific technical guidance is needed in actual implementation. Therefore, we selected a part of the technical publications of the International Atomic Energy Agency (IAEA) or from other sources as a blueprint, and successively compiled technical documents for nuclear safety regulations for reference by relevant departments and personnel. This document was compiled with reference to the Technical Report Series No. 328, Grading of Quality Assurance Requirement: A Manual, published by IAEA in 1991. IAEA Technical Report Series No. 328 replaces the previous report around the same subject, i.e. Technical Report Series No. 303 Manual on the Selection of Appropriate Quality Assurance Programmes for Items and Services of A Nuclear Power Plant . Accordingly, the present document will replace the Technical Document for Nuclear Safety Regulations HAF.J0012 Selection of Appropriate Quality Assurance Programmes for Items and Services of A Nuclear Power Plant issued by the National Nuclear Safety Administration on April 6, 1992. This document provides referential methods and examples for grading of quality assurance for items and services of a nuclear power plant to achieve the requirements and recommendations of Quality Assurance Safety Regulation HAF0400 Quality Assurance for Safety in Nuclear Power Plants and Safety Guide HAF0401 Preparation of Quality Assurance Programme for Nuclear Power Plants. Since countries and units have great differences in quality assurance grading, many methods and technologies are still under development. It is hoped that the relevant units give more feedback on the use of this document in nuclear power projects for its supplement and revision in the future. This document was organized by the Institute for Standardization of Nuclear Industry under the delegation of the National Nuclear Safety Administration and compiled by the Shanghai Nuclear Engineering Research&Design Institute Co., Ltd. It was revised during the compiling according to China's existing nuclear safety regulations, combined with the domestic management system and the actual situation of the nuclear power plants in operation and under construction. The application of this document shall be conducted in compliance with relevant laws and regulations of China. Please point out any inappropriateness or mistake and then correct it. National Nuclear Safety Administration November 7, 1994 Contents 1 Introduction 1 1.1 Background 1 1.2 Objectives 1 1.3 Scope 1 2 Principles and basic content of the quality assurance grading method 1 2.1 Principles of quality assurance grading method 1 2.2 Basic contents of quality assurance grading method 2 3 Classification of items and service 2 3.1 Determination of items and services 2 3.2 Methods and techniques 2 3.2.1 Classification by the importance to safety and operation 2 3.2.2 Classification by maturity 2 3.2.3 Classification by complexity 4 4 Selection of quality assurance level 4 4.1 Grouping of activities in quality assurance programme 4 4.2 Basis for selecting quality assurance level 4 4.2.1 Selection of quality assurance level for design 4 4.2.2 Selection of quality assurance level for procurement 5 4.2.3 Selection of quality assurance level for manufacturing 5 4.2.4 Selection of quality assurance level for construction 6 4.2.5 Selection of quality assurance level for operation 6 4.2.6 Selection of quality assurance level for management 6 4.2.7 Examples for selection of quality assurance level 7 5 Selection of grade for quality assurance requirements 7 6 Establish the relationship between items and services and applicable quality assurance requirements 7 7 Adjustment of appropriate quality assurance requirements 8 7.1 License-related activities 8 7.2 Economic aspects and cost-effectiveness considerations 8 7.3 Quality assurance programme which has been executed 8 7.4 General industrial items 8 7.5 Automatic production line 8 7.6 Confidence in formal suppliers 8 7.7 Service provided by individual or small number of staff 9 7.8 Procurement at the next level 9 7.9 Radiation exposure 9 8 Determination of appropriate quality assurance requirements 9 9 Application examples for quality assurance grading method 9 Annex I Examples for classification of items and services by the importance to safety and operation 11 Annex II The structure of the quality assurance programme and the grouping of activities 12 Annex III Examples of quality assurance level for nuclear power plant items procured 13 Annex IV Examples of division of quality assurance requirements grading 14 a. Design 14 b. Procurement 15 c. Manufacturing 16 d. Construction 17 e. Operation 18 f. Management 19 Annex V Content for grading of quality assurance requirements 20 a. Design review 20 b. Coordination between the buyer and the supplier 21 c. Document control 23 d. Measuring and testing equipment control 23 e. Non-conformities control 24 f. Record management system (Manufacturing and construction) 24 g. Maintenance control of safety-related items (operation) 26 Annex VI Typical format for quality assurance requirements in the Contract 27 Appendix I Example for selection of quality assurance level ——Emergency diesel generator 28 Appendix II Examples for selection of quality assurance level and quality assurance requirements ——Design and manufacture of piping systems 33 Table I Classification criteria for items and services 36 Table II Summary of classification results 37 Table III Example of division of quality assurance requirements grading ——Design of steam supply system 37 Table IV Example of division of quality assurance requirements grading —— Manufacture of steam supply system 38 1 Introduction 1.1 Background HAF0400(91) Quality Assurance for Safety in Nuclear Power Plants (hereinafter referred to as “the Regulations”) states: “The items, services and processes to which the quality assurance programme applies must be determined. The methods or levels of control and verification must be specified for these items, services and processes. According to the importance of the identified items to safety, all programmes must accordingly put forward regulations for controlling and verifying the quality activities affecting the item.” This requirement is further elaborated in the Safety Guide HAF0401 Preparation of Quality Assurance Programme for Nuclear Power Plants. The Guide provides specific guidance on the implementation of “the Regulations” and the selection of appropriate quality assurance requirements for items and services. However, not all items and services identified must be subject to the requirements of the Safety Guide HAF0401. Therefore, it is necessary to study and develop effective quality assurance programmes to meet necessary requirements and ensure the required confidence in quality without imposing unnecessary conditions. This can be achieved by considering the experience of the industry, grading the quality assurance of items and services, and determining the applicable quality assurance requirements. 1.2 Objectives This manual provides a practical and convenient method for the users (operating units, designers, purchasers, manufacturers, builders, operators and managers) to grade quality assurance of items and services in nuclear power plant and determine their applicable quality assurance requirements. What is introduced here is not necessarily the best practice of quality assurance grading, but a grading example similar to the grading method currently used. 1.3 Scope The grading methods described in this manual cover organizational, management, and administrative aspects that have an effect on the quality. It does not apply to quality-related technical requirements, which are based on engineering judgment and evaluation. 2 Principles and basic content of the quality assurance grading method 2.1 Principles of quality assurance grading method Quality assurance can be graded using a number of different methods. In principle, the followings are considered in determining grading methods described in this manual: (1) the importance of the item or service to the safety or operation; (2) the maturity of the areas involved (design, procurement, manufacturing, construction, operation and management); (3) the complexity of the areas involved. Good engineering judgment is required when applying this method in order to determine the level of application of each activity in the quality assurance programme (grade of the quality assurance requirements ). 2.2 Basic contents of quality assurance grading method Figure 1 illustrates the quality assurance grading method, which includes the following eight steps: (1) Divide the nuclear power plant into several major systems (Section3.1). (2) Identify specific items or services for each of the primary system (Section 3.1). (3) Consider, evaluate and classify the complexity, maturity, the importance to safety and operation of the identified item or service. The complexity and maturity of the relevant organizations also need to be evaluated (Section 3.2). (4) Choose one from three quality assurance levels for each field. Level I represents a set of the most stringent level of quality assurance requirements. Level II is less stringent than Level I but more stringent than Level III in terms of level of quality assurance requirements (Chapter 4). (5) For each level of quality assurance in each field, further divide and select the level of quality assurance requirements. Division of Level I, Level II and Level III: Level I is the most stringent, requiring completely complying with the provisions of quality assurance requirements. Level II is less stringent than Level I but more stringent than Level III for the same quality assurance requirements. The symbol "—" indicates that good industrial practice will be able to meet the requirements, and additional quality assurance requirements are not needed to improve the confidence (Chapter 5). (6) Establish an appropriate level of quality assurance requirements according to each item of quality assurance requirement at each level for each field (Chapter 6). (7) If necessary, adjust special circumstances (Chapter 7). (8) Prepare specifications or requirements document for quality assurance (Chapter 8). 3 Classification of items and service 3.1 Determination of items and services First, divide the nuclear power plant into several main systems (e.g. main coolant circuit, emergency core cooling system, containment system, etc. ). Then subdivide these systems into a number of basic units until each unit is determined to be a separate item or service. 3.2 Methods and techniques 3.2.1 Classification by the importance to safety and operation The classification method should take into account the importance of each item or service described for each function of the overall safety and satisfactory operation of the nuclear power plant. This classification method is described in Annex I. 3.2.2 Classification by maturity Items or services are categorized according to their experience and maturity in each field. The measure of maturity is whether there are experienced units and staff as well as proven designs and processes. (1) Maturity of design Maturity of design is based on the availability of equivalent designs whose effectiveness has been confirmed by performance test and field experience. (2) Maturity of procurement The maturity of procurement is based on the experience of the various units involved in the procurement process. (3) Maturity of manufacturing and construction The maturity of manufacturing and construction is based on the availability of relevant experience of item and service in compliance with similar or equivalent requirements in the manufacture or construction. The proven performance, process, and skills should be considered. (4) Maturity of operation The maturity of operational activities is based on factors such as the qualifications of nuclear power plant personnel and knowledge and experience of the various systems and components, proven operational practices and procedures, and equipment’s operating history. If there is a record of the implementation of various performance indicators of nuclear power plant, it will provide a valuable evaluation of operational maturity.

1 Introduction 1.1 Background 1.2 Objectives 1.3 Scope 2 Principles and basic content of the quality assurance grading method 2.1 Principles of quality assurance grading method 2.2 Basic contents of quality assurance grading method 3 Classification of items and service 3.1 Determination of items and services 3.2 Methods and techniques 3.2.1 Classification by the importance to safety and operation 3.2.2 Classification by maturity 3.2.3 Classification by complexity 4 Selection of quality assurance level 4.1 Grouping of activities in quality assurance programme 4.2 Basis for selecting quality assurance level 4.2.1 Selection of quality assurance level for design 4.2.2 Selection of quality assurance level for procurement 4.2.3 Selection of quality assurance level for manufacturing 4.2.4 Selection of quality assurance level for construction 4.2.5 Selection of quality assurance level for operation 4.2.6 Selection of quality assurance level for management 4.2.7 Examples for selection of quality assurance level 5 Selection of grade for quality assurance requirements 6 Establish the relationship between items and services and applicable quality assurance requirements 7 Adjustment of appropriate quality assurance requirements 7.1 License-related activities 7.2 Economic aspects and cost-effectiveness considerations 7.3 Quality assurance programme which has been executed 7.4 General industrial items 7.5 Automatic production line 7.6 Confidence in formal suppliers 7.7 Service provided by individual or small number of staff 7.8 Procurement at the next level 7.9 Radiation exposure 8 Determination of appropriate quality assurance requirements 9 Application examples for quality assurance grading method Annex I Examples for classification of items and services by the importance to safety and operation Annex II The structure of the quality assurance programme and the grouping of activities Annex III Examples of quality assurance level for nuclear power plant items procured Annex IV Examples of division of quality assurance requirements grading a. Design b. Procurement c. Manufacturing d. Construction e. Operation f. Management Annex V Content for grading of quality assurance requirements a. Design review b. Coordination between the buyer and the supplier c. Document control d. Measuring and testing equipment control e. Non-conformities control f. Record management system (Manufacturing and construction) g. Maintenance control of safety-related items (operation) Annex VI Typical format for quality assurance requirements in the Contract Appendix I Example for selection of quality assurance level ——Emergency diesel generator Appendix II Examples for selection of quality assurance level and quality assurance requirements ——Design and manufacture of piping systems Table I Classification criteria for items and services Table II Summary of classification results Table III Example of division of quality assurance requirements grading ——Design of steam supply system Table IV Example of division of quality assurance requirements grading —— Manufacture of steam supply system