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DFMEA Severity 9-10 with Occurrence 3 and Detection 3 - Actions

#1
If you end up with a failure mode with Severity 9-10 with Occurrence 3 and Detection 3 what approach shall we have?

Would it be ok to state "no action" if we can not bring O & D down without design change ? We understand that a design change can solve the dilemma but if that's not the way out .....

How shall the FMEA manual be understood in this area? How much action is needed ? the goal is of course 10-1-1 but that is not always feasible.

Thanks in advance for your feedback on this topic
 
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Chennaiite

Never-say-die
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#3
It is not unusual to have a Severity rating of 9/10 without much opportunities to mitigate Risk. Following could be done under the circumstance;

- Explain the Risk to the Top Management; Just to keep informed

- Indicate the relevant Characteristics as Critical/Safety/Legal/Etc. in the Drawing (Some may not agree to designate Special Characteristics, nevertheless, it remains a good message to Process guys)

- Share your DFMEA or outcome of your DFMEA to Process guys so that they will analyze the Causal factors in PFMEA too and enforce strong controls such as 100% check, Cpk controls, etc.
 

reynald

Quite Involved in Discussions
#4
I will push for a better detection, to the point of receiving false alarms.
I rather have this than false security.
Sometimes an indirect measurement can be used as a detecting system (i.e. if this occurs, then this (my primary concern) will probably occur too). So I add that secondary detection to my current controls.
 
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