When to Update PFMEA (Process FMEA) - Rejection is found at the customer

jkittle

Involved - Posts
#1
If a rejection is found at the customer and you make a process change, shouldn't the PFMEA be changed?

Under what circumstance would the PFMEA not be changed?
 
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prototyper

#2
Re: When to Update PFMEA

If there is a reject at the customer then your current controls are not effective and the PFMEA should be reviewed.
If you make a process change then the impacts of the change should be reviewed in the PFMEA.
Even if the review results in no change to the PFMEA, it may be good practice to record that the PFMEA has indeed been reviewed for the issue and no change made. This is documented evidence that the PFMEA is live and reviewed for all issues.
 

jkittle

Involved - Posts
#3
Re: When to Update PFMEA

I guess my question would be if the defect was produced and went undetected by the supplier and you made no change to your PFMEA then you must have not done a very good corrective action that wouldn't have affected your detection number or occurrence number.

Jerry
 

bobdoering

Stop X-bar/R Madness!!
Trusted
#4
Re: When to Update PFMEA

I guess my question would be if the defect was produced and went undetected by the supplier and you made no change to your PFMEA then you must have not done a very good corrective action that wouldn't have affected your detection number or occurrence number.
Not only that, if it occurred, and you never expected it to occur before, it should be a new failure mode line item. If it was in the FMEA, you may have an opportunity to update the frequency...:cool:
 

Jim Wynne

Super Moderator
#5
Re: When to Update PFMEA

If there is a reject at the customer then your current controls are not effective and the PFMEA should be reviewed.
There is nothing in evidence to positively indicate that the OP's current controls are not effective. We don't know the definition of "effective" that's in use.

If you make a process change then the impacts of the change should be reviewed in the PFMEA.
Even if the review results in no change to the PFMEA, it may be good practice to record that the PFMEA has indeed been reviewed for the issue and no change made. This is documented evidence that the PFMEA is live and reviewed for all issues.
Yes. :agree1: Review is definitely in order--even if the review is based on the understanding that a single escape isn't worthy of changing anything--and there should be a record of the review.
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#6
absolutely Jim.
without understanding the specifics of the fmea (which is often only guesses not analytically or empirically determined) we can make no assumptions about the efffectiveness.

we can't guarantee perfection.
what is/was the probability of occurence?
what is the detectability?
how were they determined?
what was the actual escape rate?

these are all things we must know.
 
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prototyper

#7
Re: When to Update PFMEA

There is nothing in evidence to positively indicate that the OP's current controls are not effective. We don't know the definition of "effective" that's in use.
I was not suggesting that the OP's current controls are ineffective. The question was, under what circumstances should the FMEA be reviewed!
 
A

alebrijes

#9
Hi :bigwave:

I will apreciate if somebody can tell me what is the difference between method control defined in the FMEA vs. Control Plan. The method control in the Control Plan is for the product & the FMEA consider only for the process ?
 

Jim Wynne

Super Moderator
#10
Hi :bigwave:

I will apreciate if somebody can tell me what is the difference between method control defined in the FMEA vs. Control Plan. The method control in the Control Plan is for the product & the FMEA consider only for the process ?
The PFMEA (which precedes the PCP chronologically) has fields for current process controls (prevention controls and detection controls). Depending on the output of the PFMEA process, they could change, but ultimately the existing or new control(s) will be transferred to the control plan. In other words, the controls shown on the PFMEA and PCP will normally be the same.
 

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