Detailed Rules for Safety Inspection Evaluation and Experience Feedback of Overseas Registration Units
1. Purpose
These Rules are formulated to further improve the standardization and effectiveness of the supervision of imported civil nuclear safety equipment, guide the safety inspection evaluation and experience feedback of overseas registration units, and improve the standardization and effectiveness of the evaluation and experience feedback of overseas units.
2. Application scope
These Rules are applicable to the technical evaluation carried out from the perspective of safety inspection and the experience feedback in the safety inspection stage of imported civil nuclear safety equipment during the examination process of overseas units' re-registration application.
3. Preparation basis
(1) Nuclear Safety Law of the People’s Republic of China
(2) Regulation on the Supervision and Management of Civil Nuclear Safety Equipment (Decree No. 500 of the State Council)
(3) Regulation on the Supervision and Management of Imported Civil Nuclear Safety Equipment (HAF604)
(4) Notice on Issuing the Catalogue of Civil Nuclear Safety Equipment (Revised in 2016) and Related Explanations (GUOHEANFA [2016] No.79);
(5) Registration and Approval Procedures for Overseas Units of Imported Civil Nuclear Safety Equipment.
4. Safety inspection and evaluation of overseas units
4.1 Work contents
According to the review of safety inspection documents and unpacking inspection, the contents of safety inspection and evaluation of overseas units mainly include the compliance of overseas units with China's nuclear safety laws and regulations, product performance, operation of quality assurance system, product quality, treatment of problems found in supervision and inspection and implementation of rectification.
(1) Compliance with nuclear safety laws and regulations
Evaluate whether overseas units fulfill their responsibilities and obligations stipulated by China's nuclear safety laws and regulations; whether equipment activities are carried out according to the types, scope and conditions of activities specified in the confirmation letter of registration; whether accept and cooperate with the supervision and inspection of China's nuclear safety regulation departments, and conscientiously implement the relevant management requirements put forward in the supervision and inspection.
(2) Product performance
Evaluate the performance of imported civil nuclear safety equipment provided by overseas units for China's civil nuclear facilities, and confirm that its performance can cover the scope of registration application.
(3) Operation of the quality assurance system
Evaluate whether overseas units have completed the compilation, examination and approval of relevant design documents before equipment manufacturing, and effectively control the changes of documents; whether the quality plan has been formulated and implemented effectively, and whether the quality plan can effectively correspond to the corresponding products; whether the product ex-factory test outline and procedures have been formulated and implemented effectively, and traceable test records and reports have been formed; whether it has effectively controlled the subcontracted items and services purchased by it; whether the non-conformities in the process of equipment manufacturing and testing are effectively controlled; whether the requirements of the technical specifications have been effectively implemented; whether there is fraud, illegal operation and other acts.
(4) Product quality
Evaluate whether the quality of equipment provided by overseas units meets the requirements of relevant standards and specifications and has been verified; whether there are major or common quality problems in the process of design, manufacture and safety inspection of equipment.
(5) Treatment and implementation of rectification of problems discovered during supervision and inspection
Evaluate the treatment, implementation and shutdown of problems found by China's nuclear safety regulation departments in the process of supervision and inspection by overseas units; whether it is punished by China's nuclear safety supervision department.
4.2 Evaluation process
The evaluation workflow can be found in Annex 1.
5. Experience feedback on safety inspection
5.1 Classification of experience feedback information
Combined with the importance, frequency and consequences of problems found in the safety inspection of imported civil nuclear safety equipment, these Rules divide the experience feedback information into three categories: general, important and significant.
General experience feedback information: Missing items, errors or other document quality problems in the safety inspection declaration documents of imported civil nuclear safety equipment; violation of the requirements of safety inspection related management documents; imported civil nuclear safety equipment does not meet the standards, procedures and procurement technical conditions during safety inspection, installation, commissioning and operation (non-common problems);
Important experience feedback information: In the procurement, manufacturing quality surveillance, acceptance and safety inspection of imported civil nuclear safety equipment, there are many cases that do not meet the relevant procedure documents and do not take effective corrective measures; there are common problems that the equipment does not meet the standards, procedures and procurement technical conditions in the safety inspection stage; the equipment manufacturing unit fails to effectively operate the quality assurance system and cannot prove that the equipment quality is controlled; information with reference significance for improving the design, manufacture and installation quality of imported civil nuclear safety equipment.
Significant experience feedback information: Violation of relevant management requirements of nuclear safety laws, administrative regulations and departmental rules; fraud, illegal operation and other issues; there are common quality problems in equipment, which adversely affect the operation safety of nuclear facilities.
5.2 Experience feedback workflow
1. Information collection
1. Purpose
2. Application scope
3. Preparation basis
4. Safety inspection and evaluation of overseas units
4.1 Work contents
4.2 Evaluation process
5. Experience feedback on safety inspection
5.1 Classification of experience feedback information
5.2 Experience feedback workflow
6. Others
7. Records
Annex 1 Evaluation workflow for overseas registration units
Annex 2 Feedback Information Form of Safety Inspection Experience of Imported Civil Nuclear Safety Equipment
