Posted on: 28th September 2018

The BioPhorum/BPSA change notification team have made the paper “A guide to the classification of changes to single-use biomanufacturing systems” available here. Throughout the collaborative process the team realised that there was a need for better understanding throughout the supply chain of how an organization’s customers & suppliers operate in order to improve change notification workflows and effectiveness. This decision tree tool is the first of a number of practical tools to support development of that understanding, better communication and increased workflow effectiveness.

The BioPhorum single use change notification team has been working on developing and standardizing best practice for single use change notification since 2015.  The challenges around single use system change notification have been well documented in the teams first publication (white and Ott 2015). The team then went on to propose a best practice to resolve many of these challenges (Carter et al 2017).

Because of the diverse nature of SUS changes understanding, and application of that understanding rather than prescriptive categorization of changes was seen as key in the 2017 paper. However, when attempting to change the way in which an industry communicates, there needs to be an easily accessible tool that orients practitioners to that understanding and supports embedding and growing it within organizations. This is version 1 of the decision tree and represents the teams attempt to provide that tool to orient individuals and companies to a common way of thinking and working. We are soliciting feedback on how the tool can be improved ( and will review that feedback periodically to determine if the tool can be improved by developing version 2.

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