EFFICIENT PREPARATION AND MANAGEMENT OF THE PACKAGE SAFETY CASE

In recent years the requirements for safety case management for transport packages have increased greatly. Often the Package Design Safety Report (PDSR) itself has become a massive volume, in some cases greater than that of the package itself! Software and computer developments have led to an increasing use of finite element (FE) analysis, criticality and shielding codes to support the more complex aspects of package design and engineering, and the resulting reports inevitably bulk-up the PDSR. PDSR compilers often have a lengthy and unenviable task, but by employing a consistent and logical approach, the job can be both simplified and made more readerfriendly. Those reviewing the Safety Report within the various Competent Authorities are frequently under-resourced and overworked. An ability to stand in the assessor’s shoes when writing the document is a valuable asset, and one which will benefit the review and licensing process. The Author has been involved in the preparation of PDSRs for many years, both inhouse and increasingly on behalf of third parties. This has been a process of continuous improvement, learning from experience, both self and others. New techniques and approaches have been adopted, and continue to be developed, with the objective of smoothing and hastening the compilation and approval process. Additionally, a thorough appreciation of the position and difficulties faced by the Regulators has been gained through many interface meetings and professional contact, both at domestic and International levels. ‘Applicant’s Guides’ produced by the Regulators themselves are helpful in formatting the PDSR, but much more can be done by adopting a structured and self-questioning approach. Many of the benefits are appreciated fully as and when the document has to be revised. Management of the PDSR is an area where opportunities for lateral thought are often overlooked in the interests of following tradition or established formats. This rarely results in an optimised approach for the assessor, and the approval process becomes more complicated as a result. Following a number of key principles will result in significant improvements to this process.