Does anyone have a DFMEA process Interface Matrix .xls template

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Marc

Hunkered Down for the Duration
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#2
Re: Does anyone have an Interface Matrix template

For those of us following along, what is an "Interface Matrix"?
 
P

Proepro

#3
Re: Does anyone have an Interface Matrix template

It is part of the DFMEA process. You use it to figure out which parts have interactions with each other. There are examples in this forum but not in excel so you could fill them out.
 
#7
Can someone help on this topic.
DFMEA via ISO 14971 does not require detection as a variable. Where in the ISO standard does that clearly specify? Also, where does it clearly specify in FDA requirements?

Can someone provide a matrix that will be used for DFMEA without the "detection" as a variable?

That would be greatly appreciated.

Thank you in advance. Aftab
 
J

joylc

#8
Can someone help on this topic.
DFMEA via ISO 14971 does not require detection as a variable. Where in the ISO standard does that clearly specify?
ISO 14971 2.16 defines risk as the combination of the probability of occurrence of harm and the severity of that harm. Annex D section 3 has more info about risk evaluations as well. Detection doesn't factor into the risk.

I'm not sure where it came from, but I was told that detection is not included in the design risk analysis because detecting a potential hazard is only possible when the hazardous situation occurs and in that case the user/patient is already exposed to the potential harm therefore there is no risk reduction.

The template I have looks like a normal FMEA but the detection column is absent and instead of a RPN there is a risk level which is (SEV x OCC).

Here is an interesting article about the use and misuse of FMEAs http://www.mddionline.com/article/use-and-misuse-fmea-risk-analysis
 
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