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Assessment of quality management for transport packages not requiring authority design approval
(2018)
The majority of transports of radioactive materials are carried out in packages which don’t need a package design approval of a competent authority. Low active radioactive materials are transported in such kind of packages e.g. in the medical and pharmaceutical industry and in the nuclear industry as well.
In Germany the decision to phase out nuclear energy leads to a strong demand for packages to transport low and middle active radioactive waste due to the dismantling and decommissioning of nuclear power plants. According to IAEA regulations the “non-competent authority approved package types” are the excepted packages and the industrial packages of Type IP-1, IP-2 and IP-3 and of Type A.
For the packages of Type IP-2, IP-3 and Type A an assessment by the German competent authority is required for the quality management for the design, manufacture, testing, documentation, use, maintenance and inspection. In general a compliance audit of the manufacturer of the packaging is required during this assessment procedure.
Ziel dieses Beitrages soll es sein, zum einen das Vorgehen bei der Erlangung einer Anerkennung zur qualitätsgesicherten Herstellung einer Verpackung für prüfpflichtige Versandstücke der zuständigen Behörde im Sinne des ADR Unterabschnittes 1.7.3 'Qualitätssicherung' darzustellen und zum anderen Probleme bei der Umsetzung der rechtsverbindlichen Vorschriften des Gefahrgutrechts aufzuzeigen.
The majority of transports of radioactive materials are carried out in packages which don’t need a package design approval by a competent authority. Low-active radioactive materials are transported in such packages e.g. in the medical and pharmaceutical industry and in the nuclear industry as well. Decommissioning of NPP’s leads to a strong demand for packages to transport low and middle active radioactive waste. According to IAEA regulations the “non-competent authority approved package types” are the Excepted Packages and the Industrial Packages of Type IP-1, IP-2 and IP-3 and packages of Type A. For these types of packages an assessment by the competent authority is required for the quality assurance measures for the design, manufacture, testing, documentation, use, maintenance and inspection (IAEA SSR 6, § 306). In general a compliance audit of the manufacturer of the packaging is required during this assessment procedure. Their regulatory level in the IAEA regulations is not comparable with the “regulatory density” for packages requiring competent authority package design approval. Practices in different countries lead to different approaches within the assessment of the quality assurance measures in the management system as well as in the quality assurance program of a special package design. To use the package or packaging in a safe manner and in compliance with the regulations a management system for each phase of the life of the package or packaging is necessary. The relevant IAEA-SSR6 § 801 requires documentary verification by the consignor concerning package compliance with the requirements.
Übersicht über die gefahrgutrechtlichen Anforderungen zur Bauartprüfung und dem Qualitätsmanagement für Verpackungen für nicht zulassungspflichtige Versandstücke.
Most transports of radioactive materials are carried out with packages not requiring competent authority approval of design. These encompass – in accordance with the IAEA SSR-6 regulations – packages of the classification excepted, Industrial packages Type 1, 2 and 3 and Type A packages. Currently an upsurge in number and variation of these package designs can be seen in Germany, resulting from the phase out of nuclear energy in Germany as well as e. g. increased use of radioactive material for medical purposes.
A design assessment regarding the package safety is required in the international IAEA SSR-6 regulations. BAM operates facilities for the performance of all regulatory tests required such as drop towers for a wide range of package masses and dimensions, fire test, leak tightness measurements and pressure test facilities. Experiences with several package types are shown.
Additionally, IAEA SSR-6 requires the establishment of a management system for design, manufacture, maintenance, and repair of the packaging as well as for the preparation, consigning, loading, carriage, unloading and receipt of the package. Relevant for Germany, BAM has published guidance material on the process of management system acceptance in the technical guide BAM-GGR 016. The requirements encompass quality management plans for the manufacturing of packages including independent manufacturing surveillance and specific instructions for operation, maintenance, and repair of packagings. Examples for management system specifics and requirements are given.
Since the latest edition of the IAEA SSR-6 regulations an ageing evaluation including systematic ageing management measures are required for all kind of package types. BAM is going to update the guidance material BAM-GGR 016 to support the stakeholders with relevant information to fulfil the ageing aspect for packages not requiring competent authority approval. The paper explains how the ageing aspect may be included in the safety evaluation process and the management system measures and will give an outlook for the future guidance material.