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Control Methods in Control Plan

#1
Hello All,

I'm hoping you can help answer a question I have in regards to the Control Methods column in the Control Plan.

Can you have Control Methods listed in the CP that are NOT listed in the Prevention or Detection Control columns of the PFMEA?
The scenario I'm thinking is this: you start developing the Control Chart and while populating the Control Methods column you come up with additional controls which have not been documented in the PFMEA. Do you need to go back to the PFMEA and update the Detection/Prevention Controls columns?

Is there ever a situation where a Control Method in the Control Plan would not need to be listed in the PFMEA as a Detection or Prevention control?

Thank you very much in advance!
 
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Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
Welcome Ralumar!

Chapter 6 of the APQP Manual (2nd Ed.) published by AIAG says, among other things:
In effect, the control plan describes the actions that are required at each phase of the process including receiving, in-process, out-going, and periodic requirements to assure that all process outputs will be in a state of control. During regular production runs, the control plan provides the process monitoring and control methods that will be used to control characteristics.
I would not expect to see any mention of specific product or process monitoring techniques in the pFMEA.
 

John C. Abnet

Teacher, sensei, kennari
Staff member
#3
As @Jen Kirley accurately stated...., not expected in the PFMEA

This is often an area of confusion, even amongst some that train PFMEA creation and use. The intent of the PFMEA is not to list the control details (that is why the control plan is called, well,...CONTROL plan.) Often the PFMEA controls can simply point TO the control plan. It is risky at best to redundantly place detail of controls in multiple locations. It becomes a document control nightmare preventing contradictions/inaccuracies.

Hope this helps.
Be well.
 

Jim Wynne

Staff member
Admin
#4
Can you have Control Methods listed in the CP that are NOT listed in the Prevention or Detection Control columns of the PFMEA?
I would not expect to see any mention of specific product or process monitoring techniques in the pFMEA.
The intent of the PFMEA is not to list the control details (that is why the control plan is called, well,...CONTROL plan.)
Some clarification is needed here. What the OP is apparently referring to is the two columns in the PFMEA form for "Current Process Controls--Prevention" and "Current Process Controls--Detection." Note that this apparently refers to the older version of the PFMEA form.

This has caused some confusion in the past, because for a completely new product there won't be any current process controls. In such a case the proposed process controls should be a part of the "Recommended Actions." In a case where a new product is substantially similar to an existing one, the detection/prevention process controls may be used as "current." The bottom line is that process controls should always form a part of a PFMEA. Remember--the PFMEA precedes and informs the control plan.

To answer the OP's question, the controls listed on the control plan should always be traceable to the PFMEA.
 
Last edited:
#5
Thank you All for your feedback!
Yes, I am using an older version of the PFMEA. It lists two separate columns, one for current Detection controls and another for current Prevention Controls.
 
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