How to rank Detection for Existing Preventative design controls

R

RMPMAN

#1
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
 
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B

Bill Ryan - 2007

#2
Welcome to the Cove :bigwave:

I can't speak to the medical industry's "angle" on FMEA, but in the automotive world there are two columns for the "design controls" - one is Prevention Controls and the other is Detection Controls. The definition for Detection Controls (depending on your customer :bonk: ) 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 PFMEA for the customer (wallpaper) and one that we actually use.

Did that sort of address your question?
 
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R

RMPMAN

#3
Thanks for the reply Ben,

Yes your reply helps guide me on how to approach the issue.
I wasn't sure if it was correct to list both Preventative and Detection based controls on the FMEA.

I may end up ranking all detections (Preventative or detection) and assign 10s to Failure modes that do not have ANY detection. If they have high severity and low occurence, I think (in the Medical deveice industry anyway) that some sort of detection is a worthwhile effort. If they have low severity and low detection, the rpn will be low even if there is no detection..thus the pareto do RPNs should still focus us in the right direction.

One of my concerns was that some FMEAs don't list prevention controls at all - only detection controls. To me this is a improper use of a FMEA - you couldn't create an accurate Control plan from a detection based FMEA.

thanks again,

GO
 
B

Bill Ryan - 2007

#4
While the latest edition of the AIAG FMEA manual shows the "two column" format, it is still acceptable to use a single column. You then must go thru all the listed Detection Controls and label them as "P" or "D".
 

Jim Wynne

Staff member
Admin
#5
Bill Ryan said:
While the latest edition of the AIAG FMEA manual shows the "two column" format, it is still acceptable to use a single column. You then must go thru all the listed Detection Controls and label them as "P" or "D".
Why would you want to identify detection controls with a "P"?
 
B

Bill Ryan - 2007

#6
JSW05 said:
Why would you want to identify detection controls with a "P"?
I don't. I'm merely saying that with all our "older" PFMEAs which had the single column labelled "Detection Controls" we did not have to convert them to the two column format. We did, however, have to go thru them all and add the "P" or "D" as we listed both types in the original format.
 

Jim Wynne

Staff member
Admin
#7
Bill Ryan said:
I don't. I'm merely saying that with all our "older" PFMEAs which had the single column labelled "Detection Controls" we did not have to convert them to the two column format. We did, however, have to go thru them all and add the "P" or "D" as we listed both types in the original format.
Oh, I see. Actually the old form just said "Current Process Controls." And you were doing a better job than most if you actually had prevention controls before:lol: .
 
V

Vicman

#8
Preventive

First excuse my English.
Lets see, is my understanding that you are putting preventive measures instead of control measures in your D FMEA’s .
So, this way you lower the OCURRENCE value before that the failure happens..
Now, how you detect that those preventive measures are not override!
I believe that the capability to detect it!
Will be your DETECTION factor to use and lower your detection score.

Example of a preventive measure override.

In fact, last time I was with my doctor he forgot to put me a vaccine to prevent me being sick.
So I got the flu.
 
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