FMEA versus control plan

Graciel

Involved In Discussions
#1
Hello!
I'm in a company now that in their FMEA they mention for example a check list or error proof device as a prevention control and a scanner device as detection control (just examples). And for the same operation at the control plan, they mention the software where the data is recorded as the "control method". Do you guys see this as an issue for the correlation that fmea and control plan need to have?
Or for example, during an audit, if it makes sense to the team and they can explain their reasons to do it like that.
 
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Jim Wynne

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#2
The "Control Method" field has always been a source of confusion. It's generally used to denote the record(s) involved, as it is in your case. It shouldn't be a problem.
 

Miner

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#4
Control Method can be many things. Typical control methods are SPC, mistake-proofing, visual inspection, 1st-piece inspection, lot control, etc. Control methods may be preventive in nature or rely on detection. Prevention controls reduce the FMEA occurrence rating, while detection controls reduce the FMEA detection rating.

Just a comment on error-proofing as a prevention control: If the error-proof prevents the defect from occurring, it is a prevention control. If it allows the defect to occur, but stops it from further processing, it is a detection control.
 

Jim Wynne

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Admin
#5
Control Method can be many things. Typical control methods are SPC, mistake-proofing, visual inspection, 1st-piece inspection, lot control, etc. Control methods may be preventive in nature or rely on detection. Prevention controls reduce the FMEA occurrence rating, while detection controls reduce the FMEA detection rating.

Just a comment on error-proofing as a prevention control: If the error-proof prevents the defect from occurring, it is a prevention control. If it allows the defect to occur, but stops it from further processing, it is a detection control.
I think you might be confusing Control Method with Current Process Controls. Herein lies the confusion over the field. If (for example) mistake-proofing methods are used, they are Current Process Controls and citing them again in the Control Method field is redundant. I don't think it makes much difference as far as audits are concerned, however.
 

Graciel

Involved In Discussions
#7
I think you might be confusing Control Method with Current Process Controls. Herein lies the confusion over the field. If (for example) mistake-proofing methods are used, they are Current Process Controls and citing them again in the Control Method field is redundant. I don't think it makes much difference as far as audits are concerned, however.
I think the names being so similar (process controls and control methods) are the reason for confusion. Many people think that when at the fmea and control plan this controls are "different" it is wrong in some way.
 
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