The Failure Mode and Effect Analysis (FMEA) is one of industry’s Risk Management Tools. I know a few people that dreaded having to perform an FMEA. Eyes would roll, depression set in, and they would start shaking with fear. When I think about FMEA, I get excited, especially when it pertains to processes (PFMEA). Done properly, the PFMEA will identify all potential failure modes and then subsequently assess the risk(s) associated with those process failures.

When I was teaching Quality Assurance, one of my most favorite labs was analyzing processes and preventing issues. I told the class that their company made toast. I didn’t give them any information on supplies, equipment, or the process. I had them map out the process. They, as a group, realized that making morning toast, something everybody has done while standing in their jammies, half asleep, could be very complicated.

Some of the process failures they came up with was, the toaster was unplugged, the darkness setting was set to 10, the bread could slip past the carriage and get jammed against a heating element, or a safety hazard such as water on the floor from a mop bucket spill could cause electrocution.

After we were done, we had high Risk Priority Numbers (RPN) for unplugged toasters and changed settings. Preventions included a locked cage over the darkness knob and relocating the outlet to prevent accidental unplugging. Supply issues were solved by incoming inspection. The solution to electrocution was to have rubber mats and a rule that production would not occur during a mop bucket spill.

Overall, a PFMEA could be a lot of fun. Just remember, it is a living document and the PFMEA should be reviewed periodically, especially if something in the process comes up that nobody thought of.

How do you feel about FMEAs? Please share your experiences.