GB 15219-1994 Quality assurance for transport packaging of radioactive materials
Some standard content:
National Standard of the People's Republic of China
Quality assurance for packaging used in the transport of radioactive materials
Quality assurance for packaging used in the transport of radioactive materials Subject content and scope of application
GB15219-94
This standard specifies the basic requirements for quality assurance in the design, procurement, manufacture, testing, documentation, use and maintenance of packaging used in the transport of radioactive materials.
This standard applies to all activities and units related to the quality of packaging used in the transport of radioactive materials. 2 Reference standardsWww.bzxZ.net
GB11806 Regulations on the safe transportation of radioactive materials HAF0400 Regulations on quality assurance and safety of nuclear power plants 3 Terminology
3.1 Package
A combination of various components necessary to completely enclose the radioactive contents. Specifically, it can include one or more layers of containers, absorbent materials, spacer components and radiation shielding layers, and can also include devices for cooling, absorbing mechanical shock and heat insulation. 3.2 Package
Package containing radioactive contents for delivery and transportation. 4 Quality Assurance Program
4.1 Overview
4.1.1 The responsible unit shall formulate a general quality assurance program in accordance with the requirements of this standard. The general program shall specify the control of work related to packaging for transport of radioactive materials (such as packaging design, procurement, manufacture, testing, use and maintenance, etc.). 4.1.2 The units involved in activities affecting the quality of transport packaging shall formulate their own quality assurance programs (hereinafter referred to as the program) in accordance with the requirements of the general quality assurance program and refer to the provisions of Appendix A (reference), and ensure that the program is effectively implemented according to the work schedule. 4.1.3 The program shall formulate a planned and systematic quality assurance program procedure for various activities affecting the quality of packaging for transport of radioactive materials, and review and revise the procedure regularly. 4.1.4 The program shall specify the technical requirements for various activities to be carried out, clearly specify the engineering specifications, standards and technical specifications to be used, and the measures to ensure that these requirements are met. 4.1.5 The program shall determine the organizational structure responsible for planning and implementing quality assurance activities, and clearly define the responsibilities and powers of the relevant organizations and personnel.
4.1.6 The program must specify appropriate management and verification methods or levels for the packaging of radioactive materials and their accessories based on the hazards of the radioactive contents. Based on the importance of the items to safety, the program must accordingly formulate management and verification provisions for activities that affect the quality of these items.
4.1.7 The program must specify appropriate control conditions for completing activities that affect quality. These conditions should include appropriate environmental conditions, equipment and skills required to achieve the required quality. GB 15219—94
4.1.8 The program must specify the training and assessment of personnel involved in activities that affect quality. 4.1.9 The program must specify that all activities that affect the quality of packaging must be carried out in accordance with the written procedures, rules, instructions and drawings applicable to the activity. The procedures, rules, instructions and drawings must include appropriate qualitative and/or specific acceptance criteria. 4.1.10 The program must stipulate that the management department of the unit involved in the implementation of the program shall conduct regular reviews of the implementation status and applicability of the part of the program for which it is responsible. When problems are found in the program, corrective measures must be taken. 4.1.11 The implementation of all programs should be able to prove to any competent authority with the right to review: a. The manufacturing method and materials used in the packaging are in accordance with the design and technical conditions; b. All reusable packaging manufactured in accordance with the design has been regularly inspected, and repaired and maintained when necessary, and is in good condition, and can still meet all relevant requirements and technical conditions even after repeated use. 4.2 Classification and requirements of quality assurance
4.2.1 Classification of quality assurance
Based on the importance of packaging or packaging accessories in safety, the quality assurance classification of its items is as follows: QA1: Items that are critical to safety. Generally refers to items that directly affect the containment and shielding of the cargo package, and for cargo packages containing fissile materials, it refers to items that affect the criticality control geometry. QA2: Items that have a significant impact on safety. Refers to certain structures, components or systems, whose failure does not directly affect safety, but only when combined with a secondary event or failure, it is in an unsafe state. QA3 level: Items that have no or no obvious impact on safety. Refers to certain structures, components or systems, whose failure is unlikely to affect the effectiveness of the packaging.
4.2.2 Quality assurance requirements
See Appendix B (reference).
4.3 Relationship between quality assurance classification and package type Quality assurance requirements should be commensurate with the hazard of the radioactive contents. For radioactive materials with significant hazards (such as UF.), the quality assurance level of their packaging items should be appropriately increased. 4.3.1 Exempt packages and Type 1 industrial packages
The design and manufacture of packaging should comply with QA3 quality assurance requirements. The measuring instruments and operating procedures used to determine the radioactive contents in the packaging and the radiation level of the package should comply with QA1 quality assurance requirements. 4.3.2 For Type A packages and Type I and Type II industrial packages containing non-fissile materials, items that affect the integrity of the containment system and shielding system shall comply with the QA1 quality assurance requirements; the rest shall comply with the QA2 quality assurance requirements, and items with little impact on safety shall comply with the QA3 quality assurance requirements. 4.3.3 For packages containing fissile materials (non-Type B packages), items that affect criticality safety shall comply with the QA1 quality assurance requirements, and the rest shall be handled in accordance with Article 4.3.2. 4.3.4 Type B packages
Items that affect the integrity of the containment system and shielding system and criticality safety shall comply with the QA1 quality assurance requirements; the rest shall be handled in accordance with Article 4.3.2.
4.3.5 Special forms of radioactive materials
All items shall comply with the QA1 quality assurance requirements. 5 Organization
5.1 Responsibility, authority and liaison
The responsibilities, authority and liaison of the organizational structure must comply with the provisions of Article 3.1 of HAF0400. 5.2 Interfaces between units
Interfaces between units must comply with the provisions of Article 3.2 of HAF0400. 93
6 Document control
GB15219—94
Document control must comply with the provisions of Chapter 4 of HAF0400. At the same time, a complete set of documents, including original and modified documents, should be kept. 7 Design control
7.1 Overview
7.1.1 Design control measures must be formulated and documented to ensure that the corresponding requirements of the national nuclear safety department and GB11806 are correctly reflected in the technical specifications, drawings, procedures or rules. Design control measures must also include clauses to ensure that quantitative and qualitative acceptance criteria are specified in the design documents. Changes and deviations from the specified design requirements and quality standards must be controlled. 7.1.2 Measures must be developed to correctly select the materials, parts, equipment and processes that are important to the functions of packaging, assemblies and components, and review their suitability.
7.1.3 Design control measures must be implemented in the following aspects: critical physics, radiation shielding, thermal, mechanical and accident analysis of packaging; material compatibility; in-service inspection, accessibility for maintenance and acceptance criteria for inspection and testing. 7.1.4 All design activities should be documented so that technical personnel who did not participate in the original design can make full evaluations. 7.2 Control of design interfaces
7.3 Design verification
7.3.1 Design verification must comply with the provisions of Section 5.3 of HAF0400. 7.3.2 The established design verification management measures must be consistent with the requirements of Chapters 4 and 5 of this standard. 7.4 Design changes
Design changes must comply with the provisions of Section 5.4 of HAF0400. 8 Procurement Control
8.1 Overview
8.1.1 Measures must be developed and documented to ensure that the documents for purchasing items and services include or reference the relevant requirements of the national nuclear safety department, design benchmarks, standards, technical specifications and other requirements necessary to ensure quality. 8.1.2 Procurement requests must include the relevant clauses specified in this standard, with special attention to the classification method specified in Chapter 4. 8.1.3 Procurement personnel and the competent department and its agents should have the right to access the supplier's factory facilities, items, materials and inspection and examination records. When the records need to be reviewed or approved, the supplier should submit relevant documents and information. 8.1.4 When necessary, the requirements of the relevant procurement documents should be extended to the next level of subcontractors and suppliers. 8.2 Evaluation and selection of suppliers
The evaluation and selection of suppliers shall comply with the provisions of Section 6.2 of HAF0400. 8.3 Control of purchased items and services
8.3.1 Purchased items and services shall be controlled to ensure compliance with the requirements of the procurement documents. Control includes measures such as the contractor providing objective evidence of quality, source inspection and monitoring of suppliers, and delivery inspection of items and services. 8.3.2 Written documents shall be prepared and submitted to manufacturers, users and, when necessary, to the competent authorities. 9 Item control
Item control shall comply with the provisions of Section 7 of HAF0400. 10 Process control
Control of processes that affect quality, such as welding, heat treatment and non-destructive testing, shall be implemented in accordance with the requirements of this standard and relevant codes, standards, technical specifications, guidelines or other special requirements. Measures must be taken to ensure that these processes are carried out by qualified personnel in accordance with approved 94
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procedures and using qualified equipment in accordance with existing standards. 11 Inspection and test control
11.1 Inspection outline
11.1.1 In order to verify that items, services and work that affects quality during manufacturing, maintenance and use comply with the specified procedures, specifications, instructions and drawings, an inspection outline must be prepared and implemented by the unit engaged in these works or by the unit designated by them. 11.1.2 The inspection outline must include in-service inspections of packaging and personnel training within the specified time. 11.1.3 Inspections must be carried out by personnel who are not involved in the work being inspected, and the scope of the inspection should be sufficient to ensure quality and verify that the inspection items meet the original specified requirements.
11.1.4 It must be ensured that packaging that does not meet the requirements found during in-service inspections or other circumstances shall not be used until its defects are corrected. 11.1.5 If items that have an impact on safety are required to be inspected at or witnessed at downtime points, these downtime points must be noted in appropriate documents. Work after downtime points must not be carried out without the approval of the designated unit. If work is to be carried out after a specified downtime point, it must be approved in a document before starting the work. 11.2 Test outline
11.2.1 In order to confirm that the packaging and components meet the design requirements and can be used for a long time, a test outline must be developed to determine the test items, ensure their execution and form documents.
11.2.2 Tests must be carried out according to written procedures. The written procedures should list the requirements and acceptance limits specified in the design, and the tests must be carried out by qualified personnel using calibrated instruments.
11.2.3 The test results must be given in a documented form and evaluated to ensure that the specified test requirements are met. 11.2.4 Tests shall include material tests, tests during the manufacturing process and acceptance tests, as well as various tests to see whether the requirements are met under normal transportation and accident conditions during transportation, in-service and maintenance conditions. 11.3 Calibration and control of measuring and test equipment The calibration and control of measuring and test equipment must comply with the provisions of Section 9.3 of HAF0400. 11.4 Display of inspection, test and use status 11.4.1 The test and inspection status of the components contained in the package must be marked by using marks, printed labels, process cards, inspection records, safety seals or other appropriate methods to indicate whether the items that have been tested and inspected are acceptable or listed as non-conforming items. These marks must be clear, cannot be ambiguous or erased, and cannot affect the function of the items. 11.4.2 The inspection and test status marks must be retained throughout the manufacturing, maintenance and use of the items to ensure that only items that have passed the inspection and test can be used.
12 Control of the use and maintenance of packaging
Measures should be established to control all activities including loading and unloading, printing and marking, shipping and receiving. Where necessary, they should also include the identification and control of the contents, the control of special processes such as cleaning, packing and storage of packaging, and the monitoring of the sealing, radiation and contamination level of the package. These measures should minimize any safety hazards, prevent damage, deterioration and loss of the contents, ensure that the package meets the relevant regulations, and enable the package to be approved for shipment. 13 Control of non-conformities
13.1 Measures must be established and documented to control items, processes and package contents that do not meet requirements to prevent their misuse or mispackaging. Non-conformities should be identified by marking, labeling and/or physical separation methods where practicable. 13.2 Non-conformities must be reviewed in accordance with the procedures specified in the documents and a decision must be made as to whether they should be accepted, scrapped, repaired, reworked or used for other purposes. 13.3 The responsibility for reviewing non-conformities and the authority for handling non-conformities must be specified. 13.4 Accepted items that do not conform to requirements (including deviations from purchase requirements) must be notified to the purchaser and, if necessary, to a designated reporting party. Accepted changes, waivers or deviations must be documented to indicate the "as-built" status of the nonconforming item. 95
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13.5 Repaired and reworked items must be re-inspected in accordance with appropriate procedures. 14 Corrective Actions
Corrective actions must be in accordance with the provisions of Chapter 11 of HAF0400. 15 Records
15.1 Collection, storage and preservation of quality assurance records15.1.1 A quality assurance record system must be established and implemented in accordance with written procedures, rules and the requirements of Chapter 4. Records should include the results of reviews, inspections, tests, audits, work performance supervision, material analysis, and closely related information, such as qualification certificates for personnel, procedures and equipment, required repairs and other appropriate documents. 15.1.2 Adequate quality assurance records must be maintained to provide evidence of activities affecting quality. All quality assurance records must be legible and complete and correspond to the items described. 15.1.3 Provisions must be made for the identification, collection, indexing, filing, storage, safekeeping and disposal of records. Records must be stored in a manner that facilitates retrieval and should be kept in an appropriate environment to minimize deterioration, damage and prevent loss. 15.1.4 The retention period for quality assurance records must be documented and appropriate to the type of record. Records of the "as-built" status of items must be maintained by the responsible department or its designated department throughout the effective life of the item from manufacture to storage, installation and operation. Records that do not need to be retained throughout their life must be disposed of in accordance with written procedures. 15.2 Package Records and Files
15.2.1 The owner or user of a package shall establish and maintain records of its use and maintenance for each package. Records of quality assurance measures for each package must be maintained and included in the index of the package file. 15.2.2
The packaging file shall include the following information and records:15.2.3
Approval of the packaging design by the competent authority and the design number and package serial number of each packaging;Handling and maintenance instructions;
Certificate of conformity or certificate of commissioning, including a summary of the test procedures used;d.
Test procedures for repeated inspection tests;Repeat inspection test certificates;
Records of transfer or transportation of packaging or packages (including original records);Approval of authorized modifications to the packaging and modification documents;Records of obvious damage;
Repair approval and repair documents.
When a packaging requires maintenance or repair at a location away from the location where the above detailed information is kept, the owner and user of the packaging should obtain the information required to complete the maintenance or repair task. 16 Staff training
Staff and training must comply with HAF0400 Section 3.3. 17 Auditing
Auditing must comply with the provisions of Chapter 13 of HAF0400. 96
Quality Assurance Outline
Document Control
Design Control
Purchasing Control
Item Control
Process Control
Main Points of Quality Assurance
Inspection and Test Control
Packaging Use and Maintenance Control
Control of Nonconformities
Corrective Action
Staff and Training
GB15219-94
Appendix A
Main Points of Quality Assurance Outline
(Reference)
Main Points of Quality Assurance Outline
Designer
Note: 1) If the manufacture is controlled by the designer, add × in this column: Manufacturer
User
Carrier?
Safety Assessor 3
2) Assuming the carrier is independent:
3) This column is for organizations that have independent safety assessments (internal and external) performed by safety assessors. The scope of this assessment may in fact include the design, manufacture, maintenance and handling of the package and remote transport operations. Appendix B
Quality assurance requirements
(reference)
B1 Requirements for QA1 level items
Verification;
The design should be based on relevant engineering specifications and standards and be carried out through design review, prototype identification test or alternative calculation. The procurement documents for materials or services should stipulate that only approved suppliers shall be accepted; The processing plan should stipulate material tracking and inspection, and the use of qualified special processes (such as welding and heat treatment) and welders: Testing should use identified test methods, and inspections should be carried out by qualified inspectors; l
Supervision must be carried out by designated qualified personnel; The acceptance and batch use of items after manufacturing must be made by the user (including the buyer) or by their designated agents. 97
Requirements for QA2-level items
15219—94
Design should be based on relevant engineering specifications and standards and verified by alternative calculations; use qualified special processes and welders; tests and inspections should be carried out in accordance with specified standards, specifications or technical requirements and should be performed by qualified inspectors; d.
Inspectors must be designated qualified personnel. Requirements for QA3-level items
Design should adopt current standard items. All items should be inspected according to the requirements for use. Note: The content of this appendix is an example, which only clarifies that items with different quality assurance levels correspond to different quality assurance requirements. The specific quality assurance requirements for each quality assurance level (QA1, QA2 and QA3) should comply with the provisions of the relevant documents compiled by the responsible unit (or design unit, etc.) according to the basic requirements of this standard.
Additional notes:
This standard was proposed by China National Nuclear Corporation. This standard was drafted by the Second Research and Design Institute of Nuclear Industry. The main drafters of this standard are Zhao Xianglin, You Meiying and Sun Donghui.
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