PFMEA and Control Plan Connections - TS 16949 Clause 7.3.3.2

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Jim Wynne

Staff member
Admin
#12
I was trained in 2002 and I am not quite so sure it was adequate.
The basic part of it is pretty simple:
  • Your flow diagram shows all of the relevant steps/operations in the order that they're done.
  • The PFMEA document lists all of those steps in the same order, with the same identifiers. Sequence numbers aren't required, so long as the order is maintained.
  • Based on the PFMEA as one source of input, the control plan is devised, again listing the relevant operations in the same sequence and with the same identifiers.
If, on the flow diagram, operation #1 is receiving inspection, then it should also be operation #1 on the other two documents, and so on. What probably concerned your auditor was the fact that there didn't seem to be a logical and orderly progression from the flow diagram to the PFMEA to the control plan.
 
A

atlantisind

#13
I believe by attaching only the one step from my documents I may have confused the issue. I have attached steps 70 through 110 that includes step 90 that the audit finding was based on.

I have correlated each document with the steps/processes but I do not believe this was what the auditor was looking for. I do not understand why I would reference overstacking of pallets on my control plan when it is a potential cause of failure.

I apologize for my insistance and ignorance on this but I am just a little thick headed with this one. I must be missing a bigger picture...:(
 

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Jim Wynne

Staff member
Admin
#14
I believe by attaching only the one step from my documents I may have confused the issue. I have attached steps 70 through 110 that includes step 90 that the audit finding was based on.

I have correlated each document with the steps/processes but I do not believe this was what the auditor was looking for. I do not understand why I would reference overstacking of pallets on my control plan when it is a potential cause of failure.

I apologize for my insistance and ignorance on this but I am just a little thick headed with this one. I must be missing a bigger picture...:(
In your PFMEA, the potential failure mode for "Store Product" (#90) is "Part Damage" and the potential cause is "Overstacking of pallets." Your current process controls are "Warehouse Inspection" (for prevention) and "Package Inspection During Shipping" (for detection). We should be able to logically (there's that word again :D) assume that your "current process controls" will appear on your control plan. But on the control plan, your "Product/Process/Specification/Tolerance" says "FIFO," which has nothing to do with "Part Damage" or how part damage is prevented or controlled.

In other words, your PFMEA says that the primary concern for "Store Product" is damaged parts, and that damaged parts are likely to be caused by overstacking of pallets, but your control plan says nothing about how that particular risk (overstacking) is addressed or mitigated (controlled).
 
A

Aguas

#15
Statement suggested for "Product/Process/ Spec/Tol" Column "Storage Final product on pallets not physical / cosmetic damages.

Column Breakdown
Product: Pallet
Process: Final Product storage
Spec: Physical/ Cosmetic damage
Tolerance: Zero.
 
D

dineshquality

#16
Probably the FIFO method adopted will not allow overstacking to happen. That is the reason FIFO is mentioned as the control for overstacking.
 
M

mayank_thkkr

#17
Dear Jim,

Just a question to clarify some doubts. Is is required to address all the Current Controls (Prevention and Detection) to Control Plan ? Say for example I have one failure mode, 3 root causes and total 6 current controls. So is it required to address all 6 in the control plan or only the relevant information perterning to process/ products steps requirement should be addressed in control plan ?
 

Jim Wynne

Staff member
Admin
#18
Dear Jim,

Just a question to clarify some doubts. Is is required to address all the Current Controls (Prevention and Detection) to Control Plan ? Say for example I have one failure mode, 3 root causes and total 6 current controls. So is it required to address all 6 in the control plan or only the relevant information perterning to process/ products steps requirement should be addressed in control plan ?
It's not specifically required, although I don't know how you can have process controls that aren't relevant.
 

millie6901

Registered Visitor
#19
i also had the same problem from the outcome of the audit. in summar all the control int eh PFMEA must iside the control method at Control plan, but the auditor also capture we had particle count and cleroom requiment , what no in ur control plan and FMEA ? :bonk:
 
O

OmegaS

#20
Hi!

I have a question regarding the correlation between pFMEA and CP; i'm barely new on this and right now I'm doing the Process Flow for one product, my question is, which operations must be numbered (transporting, operations, inspections, etc) and how the pFMEA must call each of those operations!?

Thank you.
 
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