PFMEA for Non-Manufacturing Processes such as audits, direct procurement, etc.


Starting to get Involved

I'm fairly competent when it comes to PFMEAs for what I would consider traditional manufacturing processes, but I was just curious how much of a "done" thing it is to conduct PFMEAs for all your other non-manufacturing processes within a BMS?

So processes such as audits, direct procurement, supplier evaluation, control of documents, nonconforming product etc etc.

If anybody has examples of such that would be really useful as well.


Bev D

Heretical Statistician
Super Moderator
I can't provide examples at this point (my organization considers these proprietary) but we do PFMEAs on business processes. currently we are doing on on our IT processes for order entry to shipment. you approach it like any other process - nothing magical or even particularly unique. get the subject matter experts, users had stakeholders in the room, map the process, and start identifying functions, failure modes, effects, etc.

sometimes its difficult at first to get people to recognize the function in a business process and to separate the failure of the function from the cause of the failure but a good facilitator can coach the team through it.

i also don't spend a lot of time on 'likelihood' or frequency of occurrence or detection as these are typically just guesses and opportunities to rationalize not taking mitigation actions. I'll keep the 'ratings' at maybe 3 levels (low medium high) and I don't use the RPN calculation... the human mind's ability to think is far more sensitive than any mathematical algorithm...


Fully vaccinated are you?
I have seen many types of FMEAs over the years. Machinery FMEAs, design FMEAs, concept FMEAs, and FMEAs on "non-production" internal systems such as Purchasing. But, then again, purchasing IS a process... FMEAs are a basic risk analysis that you can use in your own life, too. Heck - You can use an FMEA on cooking a tenderloin. Think about it. Grill not warmed up to proper temperature before putting on the meat? Temperature of grill too high or too low? Time on grill too long or not long enough? Is there enough propane for the time needed for the tenderloin to cook?


Fully vaccinated are you?
I undercooked last night. A factor I forgot - Outside temperature. About 0 degrees F here and I didn't adjust (lengthen) my cooking time to compensate.
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