(124e) Risk Assessment Tools Use Through Process/Product Life-Cycle: Start with Questions, Not Data !

Machado, J. - Presenter, 4Tune Engineering Ltd
Robalo, T. - Presenter, 4Tune Engineering Ltd - Technology Services & Products
Menezes, J. - Presenter, 4Tune Engineering Ltd

Risk Assessment is done today in the Pharma and Bio-pharma industries with a wide range of tools (FMEA, Ishikawa diagrams, Process Layouts, etc.) that are scattered across the organization and addressed in different meetings and sometimes by different teams. This arises to many problems on the workflow because the communication between each tool is almost non-existing and in order to keep consistency, all tools must be revisited each time a change is made in one of them. Also, most of these tools are not suitable for brainstorm meetings but only to aggregate the key-points. All of these problems lead to redundant workflow and interruptions in the middle of very productive brainstorm sessions on complex and multidisciplinary subjects.

Therefore, it is crucial to tackle this problem with a solution that holds in itself all the necessary tools for risk analysis and, most important, all data is connected between the tools so there is no wasted time revisiting the project.

Moreover, Risk Assessment is many times done in a brainstorming and intense environment where the ability to transport all the ideas in a quick but, at the same time, accurate and professional way is crucial.

For this, an interactive and user-friendly platform where anyone can contribute is crucial not only to hasten the Risk Assessment process, but actually improve it. The use of such tool will be demonstrated with the implementation of a case study.