The real Link between a PFMEA (Process FMEA) and the Control Plan

J

jshipley

#1
Is it fair to say that the Process Failure Mode on the PFMEA is the Control Characteristic on the Control Plan?

If so does every process failure need to be addressed in the control plan?


Lastly does anyone have an excel form that would automatically tranfer PFMEA information over to the Control Plan to begin that process?


Thanks in advance,

jakes
 
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Jim Wynne

Staff member
Admin
#2
Re: The real Link between a PFMEA and the Control Plan

Is it fair to say that the Process Failure Mode on the PFMEA is the Control Characteristic on the Control Plan?

If so does every process failure need to be addressed in the control plan?


Lastly does anyone have an excel form that would automatically tranfer PFMEA information over to the Control Plan to begin that process?


Thanks in advance,

jakes
I don't have a template for you. I know that there are commercial packages that will do it, but they tend to be a little expensive.

As for the general strategy of linking the PCP to the PFMEA, the latter should be used to help determine what appears on the control plan, and the necessary controls. It's not necessary to transfer all of the operations shown on the PFMEA document to the control plan, as it may have been determined during the PFMEA process that some operations don't present risk sufficient to require continuous control. What's listed as a failure mode on the PFMEA depends on how you construct it. I like to see process failures identified as failure modes, rather than part defects (defects are the effects of process failures). The goal, after all, is to control the process.

The process/product characteristic columns on the PCP form should be used to describe what's being controlled. For example, if you're using process failures as failure modes, you would make an entry in the process characteristics column such as, "Dwell time," then give the limits (the tolerance) in the tolerance column ("30 seconds, +/- 2 seconds," e.g.). In the part characteristic column, you would describe the part characteristic(s) that might be affected by dwell time, and list the necessary controls.
 
J

jshipley

#3
Re: The real Link between a PFMEA and the Control Plan

So i that case would you say that each function must be listed on the Control Plan - then on the Control Plan identify the controls for that function?
 

Jim Wynne

Staff member
Admin
#4
Re: The real Link between a PFMEA and the Control Plan

So i that case would you say that each function must be listed on the Control Plan - then on the Control Plan identify the controls for that function?
From my previous post:
It's not necessary to transfer all of the operations shown on the PFMEA document to the control plan, as it may have been determined during the PFMEA process that some operations don't present risk sufficient to require continuous control.
(emphasis added)
 

Miner

Forum Moderator
Staff member
Admin
#5
Re: The real Link between a PFMEA and the Control Plan

The controls identified on the PFMEA are what are recorded in the control plan.
 

Jim Wynne

Staff member
Admin
#6
Re: The real Link between a PFMEA and the Control Plan

The controls identified on the PFMEA are what are recorded in the control plan.
Actually, it's the other way around. The PFMEA asks for current process controls, which assumes that there is an identical or substantially similar process from which the current controls may be cited. So you're transferring the current controls from an existing control plan to a PFMEA document. In the case of a novel or unique process, there would be no existing controls to cite on the PFMEA document.
 
M

Mexicanforquality

#7
Re: The real Link between a PFMEA and the Control Plan

My experience about linking these documents is that you need to assure that special characteristic listed in PFMEA are all adressed as part of your PCP. I think that there is no necessary to listing every item from PFMEA to PCP, if you think that in PFMEA you will start an exhaustive analysis of your process and you will end dismissing some failure modes and giving a close follow and action plan to anothers according to your RPN
 

Miner

Forum Moderator
Staff member
Admin
#8
Re: The real Link between a PFMEA and the Control Plan

Actually, it's the other way around. The PFMEA asks for current process controls, which assumes that there is an identical or substantially similar process from which the current controls may be cited. So you're transferring the current controls from an existing control plan to a PFMEA document. In the case of a novel or unique process, there would be no existing controls to cite on the PFMEA document.
Not necessarily. If your new process was similar to an existing process, you may have existing controls that will carry over to the new process, and into the control plan.

In addition, if no existing controls exist, and you need controls based on the RPN, you should have developed these controls as part of Recommended Actions to lower the Detection Rating. Therefore, the new controls should also carry over to the Control Plan.
 

Jim Wynne

Staff member
Admin
#9
Re: The real Link between a PFMEA and the Control Plan

Not necessarily. If your new process was similar to an existing process, you may have existing controls that will carry over to the new process, and into the control plan.
I think I said that.
Jim Wynne said:
The PFMEA asks for current process controls, which assumes that there is an identical or substantially similar process from which the current controls may be cited.
In addition, if no existing controls exist, and you need controls based on the RPN, you should have developed these controls as part of Recommended Actions to lower the Detection Rating. Therefore, the new controls should also carry over to the Control Plan.
How can something that doesn't exist be a current process control? :confused: I agree that new process controls should be considered as "Recommended Actions," and in such a case the proposed controls should form a part of a prototype or pre-launch control plan. They don't actually become current process controls until the control plan reaches the production stage, at which point they may be cited in other PFMEAs as such. But if there are no current process controls, there are no current process controls. The appropriate entry in such a case is "none."
 
A

Alex Kobzar

#10
Re: The real Link between a PFMEA and the Control Plan

Is it fair to say that the Process Failure Mode on the PFMEA is the Control Characteristic on the Control Plan?

If so does every process failure need to be addressed in the control plan?

Lastly does anyone have an excel form that would automatically tranfer PFMEA information over to the Control Plan to begin that process?
I always (for manufacturing processes) copy the "Process Function/ Requirements" column from PFMEA and paste it as it is in the "Process Name/ Operation Description" of the Control Plan.
Of course all process failures (which are significant enough to require a control to be established to prevent and/or detect its occurrence) shall be present in the control plan!
 
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