Year
2019
File Attachment
a1128_1.pdf428.08 KB
Abstract
According to IAEA SSR-6 para 306 a management system shall be established and implemented to ensure compliance with the relevant provisions of IAEA SSR-6. BAM has issued a new guideline: the BAM-GGR 011 Revision 1 describes necessary quality assurance measures for design, manufacture, testing, documentation, use, maintenance and inspection of packagings for package designs requiring competent authority approval for the transport of radioactive material.The measures can be categorized as system-related and design-related. They are independently approved and monitored by the competent authority BAM and its authorized inspection experts. The qualification of the organization applying for the design approval certificate is reviewed in the context of the design approval procedure. The quality assurance measures for manufacture consist of three main steps. Pre-assessment of manufacturing documents such as quality plans, specifications etc., manufacturing inspections according the pre-assessed documents and inspection before commissioning including documentation review. Periodic inspections during operation as well as relevant specifications for use and maintenance ensure that the properties specified in the approval certificate are preserved over the package life time. Special provisions for the return on experience regarding operational feedback for design, manufacture, use, maintenance and inspection are given.Special focus shall be given here to the newly established system of manufacturing inspections including more transparent roles for a) the producers authorized inspection representative, b) the independent inspection expert, acting on behalf of the manufacturer with acceptance of BAM, and c) BAM or its the authorized expert, as Additional attention shall be drawn to the management of deviations during manufacturing and provisions for maintenance and periodic inspections.