The risk management conference participants discussed FMEA in relation to ISO 14971 and risk analysis. The conclusion was that FMEA is not risk management, nor risk analysis. Not so revolutionising, but still creates discussions.
On the two-day risk management conference in Berlin, representatives from industry and notified bodies met to discuss risk management.
Presentations were about the latest development in risk management, problems and possibilities. A lot of time was spent today discussing the relation between FMEA, risk analysis and ISO 14971. The consensus was that FMEA is not risk analysis, but one tool out of many that can be used as a part of risk management work. Still, risk management according to ISO 14971 continues much further than a FMEA, from initial conception until decommissioning. The TÜV representative said that the manufacturer is still legally responsible after the expected service life of the product has been passed, as long as the users are actually using the product. As a manufacturer, you are still also responsible for making sure that the product is “state-of-the-art”. Challenging!