R
Hi,
I'm in a workgroup that is tasked with implementing FMEA within our medical device manufacturing company. Before we "launch" the new procedure company wide we have been running scenario FMEAs to make sure we have all angles covered. A question I have is:
How do you assess Detection rankings for preventative controls?
When we list current design controls, we list controls that either prevent the failure mode or detect the cause/effect or failure mode itself.
When we rank occurence, we take into consideration all existing preventative controls. My understanding is that detection ranking is the assessment of controls that detect the cause/effect or failure mode itself. If so, what do you do with the controls that are preventative...do they get a ranking?
The preventative controls already have influenced the Occurrence value, so if you rank it again at Detection you are kind of double weighting....
thanks in advance,
P.S:
The Cove is a great learning resource.
G.O
I'm in a workgroup that is tasked with implementing FMEA within our medical device manufacturing company. Before we "launch" the new procedure company wide we have been running scenario FMEAs to make sure we have all angles covered. A question I have is:
How do you assess Detection rankings for preventative controls?
When we list current design controls, we list controls that either prevent the failure mode or detect the cause/effect or failure mode itself.
When we rank occurence, we take into consideration all existing preventative controls. My understanding is that detection ranking is the assessment of controls that detect the cause/effect or failure mode itself. If so, what do you do with the controls that are preventative...do they get a ranking?
The preventative controls already have influenced the Occurrence value, so if you rank it again at Detection you are kind of double weighting....
thanks in advance,
P.S:
The Cove is a great learning resource.
G.O
) is your ability to catch the nonconformance with the assumption that the nonconformance has occurred. Your definition of Prevention Control is the same in that it affects the Occurence rating. According to the AIAG manual, you should be working toward the prevention of the cause which would prevent the nonconformance. However, due to the above "definition" of the Detection control, you are penalized with your RPN index. My question to customers has always been "If I have a Prevention Control of 1, why would I even worry about a Detection Control (which would give a ranking of 10)?". After they hem and haw, I usually get the pat answer of "Just do it this way and fill out the Recommended Actions". This sometimes leads to having one
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