DFMEA, PFMEA and KCC's (Key Control Characteristics) Relationships

SQ_Joe

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#11
Re: DFMEA, PFMEA and KCC's

Has anyone every heard of an organization having the defined procedure (as in a work instruction) to establish KCCs?
Yes, The procedures you are seeking are described in Ford's Dynamic Control Planing, DCP, Manual.

It also describes the use of the Characteristic Matrix between the DFMEA and the PFMEA, as-well-as the use of the Correlation Matrix between the PFMEA and the Control Plan.

I have attached a 1 pager on how the elements fit together for you to examine.
 

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#12
Hi there,

My name is Aftab Ahmad and I have a dilemma and hoping you could help.

In doing dFMEA, I have always used the detection as a variable in calculating RPN. Its my understanding now that both ISO 14971 and FDA is saying that detection is not required.

My questions are below:
1. Where does it state in the ISO 14971 that it is not required.
2. Do you have an excel that can guide me using the RPN without the detection mode?

Your help would be greatly appreciated.

Thanks,
 
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