Does every Process Control listed in FMEA have to be listed in the Control Plan

Q

qualityboi

#1
Does every process control listed in your FMEA have to be listed in the Control Plan? (ie. controls prevention, controls detection). I guess what is the purpose of haveing a control plan if the control are already listed in the FMEA document?
 
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E

edelsal

#2
Hello,

I am no expert at this but, from what I understand the FMEA is a document which will list the occurence, severity detection and based on those numbers will give you a "Risk Number" on which you can base your frequencies of inspections for your control plan.

Your control plan will be the actual actions to be done during your regular day to day (type of inspection, instrument to use, documentation to use, etc).

My 2 cents...

Edelsal
 

Jim Wynne

Staff member
Admin
#3
Does every process control listed in your FMEA have to be listed in the Control Plan? (ie. controls prevention, controls detection). I guess what is the purpose of haveing a control plan if the control are already listed in the FMEA document?
The PFMEA process should be used to help determine the needed controls in production. For some PFMEA items, risk analysis may lead to a decision against invoking controls. This means that not all items shown on the PFMEA document will also appear on the control plan. Nonetheless, if you say in your PFMEA that certain controls are (or will be) in place, those controls should be shown in your control plan.
 

Stijloor

Staff member
Super Moderator
#4
The PFMEA process should be used to help determine the needed controls in production. For some PFMEA items, risk analysis may lead to a decision against invoking controls. This means that not all items shown on the PFMEA document will also appear on the control plan. Nonetheless, if you say in your PFMEA that certain controls are (or will be) in place, those controls should be shown in your control plan.

Excellent points! :agree1:

Allow me to add that the the effectiveness of the process controls will be demonstrated by the absence of process failure modes. And that should close the loop.

Stijloor.
 

qusys

Trusted Information Resource
#5
FMEA is used in a preventive way, also to improve controls or add other controls in case of high RPN.
It depends on the evaluation of the organization.
In this sense FMEA and control plan are strictly linked.
From FMEA done in a constructive way , you can improve your control plan for specific part or parts family.


Does every process control listed in your FMEA have to be listed in the Control Plan? (ie. controls prevention, controls detection). I guess what is the purpose of haveing a control plan if the control are already listed in the FMEA document?
 
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