New approach for risk analysis and management in medical engineering

Risk management in its current form does not fulfill today´s requirements for enterprises in risk-sensitive industries. Risks resulting from well-known boundary conditions, such as shorter development times, a higher number of variants or global markets can just be identified inadequately by existing methods. In particular the increased product complexity, e. g. in the medical engineering branch, makes it difficult for companies to assess risks correctly and individual persons are less able to judge a product thoroughly. To improve the risk management process the iFEM-me thod (innovative function effect modeling) was developed, which is a new approach to identify and assess risks. First of all, critical risk areas are identified by the creation of a tree that visualizes the actual state of a complete technological system. After that, these critical risk areas are analyzed by an object model and a function-effect model. The result is a comprehensive risk inventory in which the cause and assessment for each of the risks have been defined. These results can be directly addressed through an effective risk mi tigation. The validation of iFEM was carried out in an enterprise from the medical engineering industries. The results were structured and documented so that the information could be used to improve the method. iFEM is a suitable method to model an overall system for the multidisciplinary analysis of a complex product. It permits a common understanding of a system and combines manufacturing and operational processes with system functions and inherent risks. The benefits of iFEM are the systematical risk identification of inconsistencies and expansion of employee´s system understanding.