Process Failure Mode and Effects Analysis (PFMEA) is the most widely used tool for process risk analysis in Medical Devices. Although ISO 14971 does not demand a specific tool to be used for process risk management it very well states, that risks should be managed by systematically using experience, insight and judgment. In general, a PFMEA is a very suitable tool to fulfill this requirement but working on many PFMEAs in different companies has shown that the same mistakes are made almost everywhere. To avoid the most common mistakes and use the PFMEA as the strong tool it can be, the following points should be considered.
Getting the right team – PFMEAs should be performed in a team where all disciplines involved in the processes are represented. This is key to make sure, as many different insights and experiences as possible flow into the analysis. Although this is very beneficial, it may also lead to highly detailed discussions and loss of focus. Therefore, thorough moderation of the meetings is indispensable.
Planning instead of reacting – PFMEAs are a very strong tool to bridge the gap between constant firefighting and real risk management. Based on the expertise of the above-mentioned multidisciplinary team on manufacturability, trends, regulations and the production itself, the PFMEA can be used to determine upcoming issues and prioritize on processing steps. Following the route drawn by the PFMEA, process risks can be reduced upfront whereby process results are improved and a higher stability is achieved. When starting a PFMEA on already existing processes a company has to suffer from mindset and process changes and, at worst, reconstruction of manufacturing lines. For that reason, a PFMEA should start with the very beginning of process development in order to reduce risks by design.
Thoroughly defining harms – During a PFMEA, potential harms are often defined and evaluated on the go. This can lead to unnecessary diversification and inconsistency in evaluation. Whenever possible, hazardous situations and potential harms should be linked to the product risk analysis and the according severities. Collecting, clearly defining and rating all identified harms will avoid confusion, misunderstanding and contradictions.
Knowing the numbers – When it comes to risk scores it is always better to base them on facts and numbers rather than guesses. Usually the first mistake lies in the risk management plan, where the definition of risk scores is often based on vague, imprecise terms. Classifying scores using countable measures allows to assign scores based on measurable numbers rather than gut feeling. This will not only add a high degree of information to a PFMEA but it also allows to easily re-evaluate scores based on newly derived information.
Enabling process improvement – Often there is a tendency towards detecting issues rather than preventing them from happening in the first place. Detective measures will reduce the overall score suggesting the risk is under control. However, focusing on detective measures might also cover up instable processes and therefore inhibit process improvement. Focusing on preventive measures on the other hand drives process development and stabilization.
Taking all of the above points into account in a company’s risk management process will make the difference between treating process risk analysis as a simple must have for compliance reasons only and using it as a strong aid and guidance for process development and risk control.
Written by Lisa Kamber, Senior Consultant
Subscribe to EUMEDIQ’s newsletter – Link