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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.