Not easy to perform FMEA

I read an entry about risk analysis on the Westgard Web which prompts the following comments…

First, I basically tune out most of the official (CLIA, CLSI) regulations or standards about risk management. After a thorough analysis of EQC and EP23 and many comments – largely without effect – it’s time to move on. Until someone has an epiphany (maybe it will be me) there doesn’t seem to be much point.

But as to how well risk management will be done by laboratories, two anecdotes come to mind.

When I started to sell risk management software to hospitals (since retired and no longer available or supported) I started with a free beta version to those who would send me an email. The emails I got scared me. To paraphrase one – “I would love to evaluate your software. This FMEA is taking way too long.” Basically, what was desired was a menu of FEMA topics so that the user could click on one, such as for example “patient falls” and then get a completely filled in FMEA. They could then say, that looks right – done! [Note: There was a joint commission requirement for a hospital to perform at least one FMEA a year.]

At a medical device company, where FMEA was a required step, I was contracted to help. The problem was meetings were always scheduled during lunch. When I asked why, I was told, “We’re too busy, we can’t afford to slow down our real work.” Not the best start.

Some reasons that FMEA is so difficult:

  • Many believe it is not needed, perhaps because the basic FMEA questions are asked throughout the design process
  • It can be adversarial because the person who owns or developed the process is present as it is being discussed (challenged)
  • It is inherently difficult to brainstorm to come up with failure modes and judge their likelihood and to come up with useful mitigations

This is why FRACAS is often more successful. But it is not a substitute for FMEA. Both should be done. And by the way, some people perform a FRACAS and call it a FMEA. How do I know? Because they describe an improvement to the observed failure rate. In FMEA, there is a potential, not an observed failure rate.


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