ISO 14971 or FMEA: Which Should You Use?

When determining hazards in medical-device design, the ISO standard is better

This may be stating the obvious, but engineers are generally very analytical. One of the areas where this trait comes to the fore is in evaluating all the ways things can go wrong. This includes exposure and using tools like failure mode and effects analysis (FMEA).

As an engineer, there’s a good chance you were first introduced to FMEA in college, along with several other tools for looking at and analyzing failures. So it makes sense that when you start working on medical-device product development, and you’re told to address risks, you’ll fall back on what you learned once upon a time.

Out comes your trusty FMEA template spreadsheet. You begin to fill it out... and things can quickly grind to a halt. You start asking yourself a bunch of questions, such as:

Am I creating an application FMEA (AFMEA) or a design FMEA (DFMEA)? And what exactly is the difference between them?

How do I link the AFMEA and DFMEA together? Do I need to link them together?

What do I put for the potential effect of the failure? Is it the effect on the patient, the device, or peripheral devices?

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Comments

Watch out!

Jessica, I think this question is not fair. A norm you follow, a method you choose!

Top down or Bottom up?

Jesseca,

Thank you for a very nice article. I found the following observation interesting.

“In an FMEA, filling in the columns from left to right, you identify potential failure mode, then potential failure effect, and then potential causes. In ISO 14971 terminology these would be hazardous situation, harm, and then foreseeable event, respectively.

No wonder filling out an FMEA is difficult: You’re forced to mentally jump around instead of logically stepping through it. It’s much easier to think about the series of events (i.e., foreseeable events) that lead to circumstances where people, property, or the environment is exposed to a potential source of harm, and then consider what the resulting harm is.”

I think you make a good point if you view the activity as Cause à Effect, but in many engineering situations we work from Effect à Cause. This is basically the difference between a Top Down or Bottom Up approach.

Regards,

John Flaig, PhD, FASQ