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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.
In accordance with the IAEA transport regulations, the design of special form radioactive material (SFRM) shall resist a severe transport accident without undue loss or dispersal of radioactive material. The safety assessment for design approval includes besides the program for physical tests (impact, percussion, bending and heat test) also the evaluation of the management system for design, manufacture, testing, documentation, use, maintenance, and inspection.
SFRM source design plus management system shall ensure, that every specimen of the approved design is able to survive the severe mechanical and thermal tests at any time of its SFRM-working life.
Due to the long-term use of SFRM designs in most cases, the assessment of the source ageing behavior is an important aspect in the approval procedure. Different fields of application imply a wide range of environmental conditions, from clean room atmosphere to highly aggressive industrial conditions. Besides of radioactive content, corrosion is a main factor for possible SFRM design degradation.
Although the IAEA Advisory Material SSG-26 already implies an indication of the need for considering ageing mechanisms, suitable amendments in the regulatory requirements of SSR-6 should be introduced to make the approval procedure more transparent and help to reduce rounds of questions by the authority. A supplementary requirement for considering of ageing mechanisms could be a helpful contribution to an international harmonization of the approval procedure.
This paper will describe major influencing factors to be considered to assess the ageing behavior of a SFRM design and will identify the need for a regulatory specification of a SFRM-working life as basis for the assessment of the SFRM design regarding time-dependent weakening. A proposal for an explicit requirement for consideration of ageing mechanisms in safety assessment of SFRM, which should be considered in the ongoing SSR-6 revision cycle, will be explained.
Since 2005, several European countries, coordinated by the European Association of Competent Authorities (EACA), have been developing a guide on contents and structure of the documentation demonstrating the compliance with the regulations for packages for the transport of radioactive material (package design safety report, PDSR). This guide has been periodically improved, considering feedback from Designers and authorities.
Taking into account the successful application of this guide in Europe, in 2013 the International Atomic Energy Agency (IAEA) decided to establish a similar guide as an IAEA document for promotion of worldwide use. The development of this IAEA guide started from the latest version of the European PDSR guide. In 2016/2017, during a 120-day review period, comments on the draft were received from member states and international organizations. These were incorporated into the draft in a series of meetings in 2017.
In another meeting in December 2018 the draft was updated to be in line with the latest revision of the IAEA Regulations for the Safe Transport of Radioactive Material (SSR-6).
In this process the draft has been improved significantly, regarding structure as well as implementation of a graded approach depending on the package type, and clarified.
This paper points to the major considerations in developing the guide and important improvements over the last version of the European PDSR guide.