HAF003英文版

HAF003 Quality Assurance for Safety in Nuclear Power Plant A Code of Practice （issued by the National Nuclear Safety Administration of PRC in July 27, 1991） Contents 1. Introduction ………………………………………………………..…2 2. Quality Assurance Program……………………………………….…..4 3. Organization ………………………………………………………….5 4. Document Control ………………………………………………..…..7 5. Design Control …………………………………………………...…..8 6. Procurement Control …………………………………………………9 7. Item Control ………………………………………………………....11 8. Process Control ……………………………………………………...12 9. Inspection and Test Control …………………………………………13 10. Non-conformance Control …………………………………………..14 11. Corrective Actions………………………………………………...…15 12. Records………………………………………………………………15 13. Audits………………………………………………………………..16 Definitions……………………………………………………………....18 1. Introduction 1.1 General 1.1.1 This Code of Practice specifies basic requirements for quality assurance in on-land stationary thermal neutron reactor nuclear power plants. 1.1.2 The principles provided by this Code of Practice are applicable for both nuclear power plants and other nuclear facilities as well. 1.1.3 An overall quality assurance program for a nuclear power plant as well as separate programs for each of the constituent area of activity (e.g., siting, design, fabrication, construction, commissioning, operation and decommissioning) shall be properly developed and effectively implemented to ensure safety in a nuclear power plant. This Code of Practice provides principles and objectives for the development and implementation of these programs. The principles to be followed for each type of program are the same. 1.1.4 It shall be noted that in performing a particular task (e.g., in siting, design, fabrication, construction, commissioning, operation and decommissioning) the major responsibility for achieving required quality rests with those assigned the task and not with the personnel who seek to by means of verification ensure the quality has been achieved. 1.1.5 Quality assurance program shall include the activities necessary for compliance of items and service with quality requirements, for ensuring by means of verification that the required quality has been achieved, and for collecting subjective evidence for the above mentioned activities. 1.1.6 Quality assurance is an essential part of “effective management”. Effective management contributes to the achievement of quality through thorough analysis of the tasks to be performed, identification of required skills, the selection and training of appropriate personnel, the use of appropriate equipment and procedures, the creation of a satisfactory environment in which the activities are to be performed, and a clear recognition of the responsibility of those who are to undertake the tasks. Briefly speaking, a quality assurance program shall specify the requirements for and approach to all activities affecting quality, including verification that each task has been properly performed and that necessary corrective action has been implemented. It shall also provide for the production of documentary evidence to demonstrate that required quality has been achieved. 1.1.7 The specific approaches adopted to implement this Code of Practice, both at overall plant level and at the constituent activity level, may vary from organization to organization. However, at any case, the principles established in this Code of Practice shall be followed and detailed implementation procedures shall be developed accordingly. It shall be recognized that a quality assurance program shall be precise and enable easy implementation while ensuring the integration of both technical and managerial aspects of the activity. 1.2 Scope This Code of Practice provides the principles and objectives for the development and implementation of a quality assurance program during siting, design, fabrication, construction, commissioning, operation and decommissioning in a nuclear power plant. These principles and objective are applicable for all activities affecting quality of items and service, such as designing, purchasing, fabricating, manufacturing, handling, shipping, storing, cleaning, erecting, installing, testing, commissioning, operating, inspecting, maintaining, repairing, refueling, modifying and decommissioning. They are applicable by all those responsible for the nuclear power plant, by plant designers, suppliers, architect-engineers, plant constructors, plant operators, and other organizations participating in activities affecting quality. The Safety Guideline specified in Appendix I serves as interpretation of and supplement to this Code of Practice. 1.3 Responsibility 1.3.1 In realizing its responsibility for ensuring the health and safety of the public, operating organizations shall establish overall quality assurance program applicable to nuclear power plants in compliance with the requirements of “Regulations on Safety of Civil Nuclear Facility in PRC ” and this Code of Practice, and submit to state nuclear safety regulatory body for approval. 1.3.2 The operating organizations assuming overall responsibility for a nuclear power plant shall be responsible for the establishment and implementation of the overall quality assurance program for the whole nuclear power plant. This organization may delegate another organization to establish and implement all, or a part, of the program but shall still retain responsibility for the effectiveness of the overall program without prejudice to the contractors’ obligations or legal responsibilities. 2. Quality Assurance Program 2.1 General 2.1.1 An overall quality assurance program shall be established consistent with the requirements specified in this Code of Practice as an integral part of the nuclear power plant project. The overall program shall provides for the control of the constituent activities associated with a nuclear power plant, such as siting, design, fabrication, construction, commissioning, operation and decommission. The control of each constituent activity shall also be consistent with this Code of Practice. 2.1.2 Management for the whole plant and for each constituent aspect of activity shall effectively implement the quality assurance program consistent with the project progress schedule, including the procurement of material for long-delivery items. Management department of operation in a nuclear power plant shall ensure the effective implementation of quality assurance program during the period of operation. 2.1.3 All programs shall define the organizations responsible for the planning and implementation of quality assurance activities, as well as the responsibility and authority of various organizations and personnel involved. 2.1.4 In developing the program, the technical aspects of various activities shall be taken into consideration. The program shall include provision to ensure the identification of and compliance with requirements of appropriate recognized engineering codes, standards, specifications and practice. Quality assurance requirements shall also include provisions specifying the technical objectives to be achieved, apart from those for control of managerial aspect. 2.1.5 Items, services and processes to which the quality assurance program will apply shall be identified. Appropriate methods or levels of control and verification shall be assigned to those items, services and processes. All programs shall provide for control and verification over activities affecting the quality of items to an extent consistent with their importance to safety. 2.1.6 All programs shall provide for appropriate control condition for accomplishing activities affecting quality, including appropriate environmental conditions, equipment and skills needed for achieving required quality. 2.1.7 All programs shall provide for the training of personnel performing activities affecting quality. 2.1.8 All programs shall be evaluated and updated periodically. 2.1.9 All programs shall provide for the language used for documentation. Measurements shall be taken to ensure that personnel performing the quality assurance functions are adequately proficient of the language in which the program is written. Translations of the document shall be reviewed by qualified persons to verify conformance to the original. 2.2 Procedures, instructions and drawings 2.2.1 All programs shall provide that all activities affecting quality in a nuclear power plant, including those performed during the operation of a plant, shall be accomplished in accordance with applicable written procedures, instructions or drawings. Procedures, instructions and drawings shall include appropriate qualitative and/ or quantitative acceptance criteria for determining that various activities have been satisfactorily performed. 2.2.2 Procedures for implementing the quality assurance programs for different phases of nuclear power plant project in a systematic and planned manner shall be established and documented by the organizations performing the constituent activities. The procedure, including the technical skills needed, shall be precisely stated, and be easy to implement. The procedure shall be reviewed and updated periodically to ensure adequate coverage of these activities. 2.3 Management review All program shall provide that management of the organizations participating in the program implementation shall periodically review the status and adequacy of the part of quality assurance program for which they are responsible. Corrective actions shall be taken when program deficiencies are discovered. 3. Organization 3.1 Responsibility, authority and communications 3.1.1 A documented organizational structure, with clearly defined functional responsibilities, level of authority, and lines of internal and external communication, shall be established for management, direction and execution of the quality assurance program. In working on the organizational structure and functional assignment, it shall be recognized that implementation of quality assurance program involves both performers and verifiers, not a sole domain of a single group. The organizational structure and functional assignment shall be such that: (1) Quality objectives are accomplished by the personnel designated to perform the activity; this may include examination, checks and inspections by the personnel performing the task. (2) When it is necessary to verify that the established requirements are met, it is carried out by those who do not have direct responsibility for performing the work. 3.1.2 The authority and duties of persons and organizations responsible for performance and verification of quality assurance activities shall be delineated in written form. These persons and organizations perform the quality assurance functions of (1) ensuring that an appropriate quality assurance is developed and effectively implemented and (2) verifying that all activities are satisfactorily performed. These persons and organization shall have sufficient authority and organizational independence to identify quality deficiency, to suggest, recommend or provide solutions, and when necessary, to initiate actions to prevent non-conforming, deficient or unsatisfactory items from being further processed, delivered, installed or used, until proper disposition has been achieved. 3.1.3 The persons and organizations shall report to a management of a high enough level for acquiring the above mentioned authority and sufficient organizational independence, including sufficient independence from cost and schedule consideration. Since such factors as personnel number, activity type and location may vary, the organizational structure in which the activity is performed may take different forms, provided that the persons and organizations performing the quality assurance functions have acquired the needed authority and organizational independence. However, whatever form it may take, the individual or individuals responsible for effectively implementing any portion of a quality assurance program in any location where activities affecting quality are being performed shall have direct access to management of a level high enough to achieve effective implementation of quality assurance program. 3.2 Organization interface Where multiple organizational arrangement exist, the responsibilities of different organizations shall be clearly defined, and interfaces and co-ordination among organizations be ensured. Provisions shall be made for communication among organizations and organizational groups participating in activities affecting quality. The communication of essential information shall be by means of appropriate documentation. The type of documents shall be identified and its distribution shall be properly controlled. 3.3 Staffing and training 3.3.1 Appropriate plan shall be developed for selection and training of personnel performing activities affecting quality. The plan shall reflect the schedule of activities so as to allow adequate time for assigning or selecting and training needed persons. 3.3.2 Qualification evaluation shall be conducted on all persons performing activities affecting quality on the basis of education, experience and business proficiency required for performing specifically assigned tasks. Training procedures and programs shall be developed to ensure that these persons acquire and maintain suitable proficiency. As appropriate, achievement and maintenance of proficiency shall be marked by the issue of a written statement, such as a certificate. 4. Document control 4.1 Document preparation, review and approval The preparation, review, approval and issue of documents needed for performance and verification of work, such as procedures, instructions and drawings, shall be properly controlled. Controlling measurements shall include a clear identification of the persons and organizations responsible for the preparation, review, approval and issue of documents recording activities affecting quality. The persons and organizations responsible for review and approval shall be entitled to access pertinent background information which services as evidence for review and approval. 4.2 Document issue and distribution A system of document release and distribution shall be established in conformity with the most recent distribution list. Appropriate measures shall be taken to ensure that all persons participating in these activities understand and use the correct and appropriate documents for performing the activities. 4.3 Document change control Document control shall be reviewed and approved in compliance with established procedures. Reviewing and approving organizations shall have access to pertinent background information on which approval is based, and shall have sufficient knowledge of the requirements and intent of the original document. The change shall be reviewed and approved by either the same organization that have perform review and approval of the original document, or other organization that have been specifically designated. A timely notification of the changes and their status shall be promptly relayed to all related persons and organizations so as to preclude the use of outdated or inappropriate document. 5. Document control 5.1 General 5.1.1 Appropriate control measures shall be developed and documented to ensure that all the established design requirements, such as the requirements, design parameter, codes and standards of state nuclear safety regulatory body are correctly reflected in specifications, drawings, procedures and instructions. They shall include provisions to ensure that applicable quality standards are specified and stated in design documents. Changes to and deviations from established design requirements and quality standards shall be controlled. Appropriate measures shall be established for the selection, as well as for the review for suitability of application, of any materials, parts, equipment and processes that are important to the function of structure, system or component. 5.1.2 Design control measures shall be applied to items such as the following: radiation protection; human factors; fire protection; physics and stress analysis; thermal, hydraulic, seismic and accident analysis; compatibility of materials; accessibility of in-service inspection, maintenance and repair; and acceptance criteria for inspection and test. 5.1.3 All design activities shall be documented so as to permit adequate evaluation by technical personnel who have not participated in previous design. 5.2 Design interface control The internal and external interface between different organizations and organizational units undertaking design work shall be provided in writing. The responsibility for each organization and each organizational unit shall be specified in sufficient details, including the development, review, approval, release, distribution and revision of document pertinent to interface. 5.3 Design verification 5.3.1 Design control measures shall provide for verifying the adequacy of design and design method, such as by design review, by using other calculation means, and by implementing adequate test program. Design verification shall be performed by persons or groups other than those who have participated in original design. Verification methods shall be determined by the designing organization, and shall provide design verification result in compliance with the specified scope in documental form. 5.3.2 When a test program is used in place of other verifying or checking methods to verify the adequacy of specific design attribute, it shall include appropriate qualification test on prototype units under the most adverse condition for the specific design features being verified. Where testing can not be performed under the most adverse condition, testing under other condition is permitted provided that the results can be extrapolated to the most adverse design condition and if they can verify a specific design feature. 5.4 Design change Procedures for design change, including field changes, shall be developed and documented. The technical impact the changes will cause shall be given sufficient consideration and required actions documented. The same design control measures as those for the original design shall be adopted for the changes. Design change document shall be reviewed and approved by the same group or organization that have reviewed and approved the original design document, unless other organizations are designated specifically. This designation of alternative organizations shall be conditional on their having access to pertinent background information, on their demonstrating competence in the specific design area of concern, and on their having sufficient knowledge of the requirements and intent of the original design. Design information shall be relayed to all persons and organizations involved in a timely manner. 6. Procurement control 6.1 General 6.1.1 Appropriate measures shall be established and documented to ensure that documents pertinent to procurement of items and service include or invoke requirements of the State Nuclear Safety Authority, design base, standards, specifications, and other requirements needed for quality assurance. 6.1.2 Procurement requirements for assuring quality shall include, but not necessarily be limited to, the following, as applicable: (1) A statement of the scope of the work to be performed by the supplier (2) Established technical requirements for items and service by reference to documents such as codes, standards, procedures, instructions, and specifications, including their revisions. (3) Tests, inspections, and acceptance requirements, and any special instructions and requirements related to these activities. (4) Provisions for access to suppliers’ facilities and records for the purpose of source inspection and au