FMEA for 2008
I can think of no better technique than FMEA to get engineers together and “hash out” the possible failures of a design or process. The word HASH is appropriate because of all the ingredients necessary to get it to taste good. Many FMEA’s are not developed with enough ingredients to assure that the true issues come out.
All engineers believe they have done a great job, this is not what the FMEA is about. The FMEA is about where and when unknowns can affect performance. The testing and verification of the design or validation of the process should be a confirmation of the FMEA outputs. When risk is uncovered, the actions that come from the FMEA should affect both the design of the product and/or process but also the testing for verification and validation. Too many times we hear “we will test for that” But what if it fails? Will there be enough time to redesign and reconfirm the design? These issues should be discussed during the FMEA process.