1 Scope
This standard specifies basic requirements on quality assurance for design, procurement, manufacture, handling, transportation, storage, inspection, test, operation, maintenance and improvement for packaging used in transport of radioactive materials.
This standard is applicable to all the activities concerning the quality of packaging used in transport of radioactive materials.
2 Normative References
The following standards contain provisions which, through reference in this text, constitute provisions of this standard. For dated reference, subsequent amendments to (excluding correction to), or revisions of, any of these publications do not apply. However, the parties to agreements based on this standard are encouraged to investigate the possibility of applying the most recent editions of the standards. For undated references, the latest edition of the normative document referred to applies.
GB 11806-2004 Regulations for the Safe Transport of Radioactive Material
3 Terms and Definitions
For the purposes of this standard, the terms and definitions specified in GB 11806-2004 and those listed below apply.
3.1
Packaging
The assembly of various components necessary for complete closure of radioactive contents. Generally, it may include one or more chamber(s), absorbing materials, distance pieces, radiation shields, auxiliary devices for aeration, emptying, ventilation and depression, components for cooling, absorbing of mechanical shock, handling, tying and heat insulation, and auxiliary components for integral package. Packaging may be case, drum or similar vessels, or freight container, tank or solid bulk container.
Foreword i
1 Scope
2 Normative References
3 Terms and Definitions
4 Quality Assurance Program
4.1 Overview
5 Classification and Requirements of Quality Assurance
5.1 Classification of Quality Assurance
5.2 Quality Assurance Requirements
5.3 Relationship between Quality Assurance Classification and Package Type
6 Organization
6.1 Responsibilities, Authorities and Interfaces
6.2 Personnel Allocation and Training
7 Control of Design
7.1 Overview
7.2 Control of Design Interface
7.3 Design Verification
7.4 Design Change
8 Control of Procurement
8.1 Overview
8.2 Evaluation and Selection of Supplier
8.3 Control of Purchased Items and Services
9 Control of Documents
9.1 Preparation, Examination and Approval of Documents
9.2 Issue and Distribution of Documents
9.3 Control of Document Change
9.4 Control of Electronic Record and Data
10 Control of Items
10.1 Marking of Materials, Parts and Components
10.2 Control of Handling, Transportation and Storage
10.3 Control of Packaging Application, Maintenance and Improvement
11 Control of Manufacturing Process
12 Control of Inspection and Test
12.1 Inspection Program
12.2 Test Program
12.3 Calibration and Control of Measuring and Testing Equipment
12.4 Display of Inspection, Test and Operation Conditions
13 Control of Nonconforming Items
14 Corrective Measures
15 Quality Assurance Record
15.1 Collection, Storage and Preservation of Quality Assurance Records
15.2 Records and Archives for Packaging
16 Monitoring
16.1 Overview
16.2 Monitoring Plan
Appendix A (Normative) Key Points of the Quality Assurance Program
Appendix B (Informative) Quality Assurance Requirements
Appendix C (Normative) Preservation Requirements of Quality Assurance Records
