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Hi. I work in the medical device industry and have a question about occurrence rankings in Design FMEA. In many years of using d-FMEA I've seen occurrence rankings based on both:
the probability of occurrence of the failure mode
and
the probability of occurrence of the effect of the failure (probability of harm)
The idea of the latter being that occurrence of a failure mode may or may not result in harm.
I'd love to hear your thoughts on the application. Thanks!
the probability of occurrence of the failure mode
and
the probability of occurrence of the effect of the failure (probability of harm)
The idea of the latter being that occurrence of a failure mode may or may not result in harm.
I'd love to hear your thoughts on the application. Thanks!