PFMEA and Control Plan Connections - TS 16949 Clause 7.3.3.2

I am struggling with a recent audit finding...

The PFMEA and Control Plan system is not fully effective.
"Per 7.3.3.2, the PFMEA in line 90 states overstacking of pallets (under potential cause of failure) while the control plan, line 90 (under Product/Process/Specification/Tolerance) states FIFO.


So to correct this, the "Current Process Control" (Prevention or Detection, whichever fits best) now lists the "Process" from the Control Plan to tie the two documents together.

I am not sure if I am fixing this correctly because my Control Plan still says FIFO and my PFMEA still says Overstacking.

Re: PFMEA and Control Plan connections

atlantisind said:

I am struggling with a recent audit finding...

The PFMEA and Control Plan system is not fully effective.
"Per 7.3.3.2, the PFMEA in line 90 states overstacking of pallets (under potential cause of failure) while the control plan, line 90 (under Product/Process/Specification/Tolerance) states FIFO.


So to correct this, the "Current Process Control" (Prevention or Detection, whichever fits best) now lists the "Process" from the Control Plan to tie the two documents together.

I am not sure if I am fixing this correctly because my Control Plan still says FIFO and my PFMEA still says Overstacking.

Click to expand...

What sort of audit was this? I'm assuming the standard is ISO/TS 16949, and if that's the case, there's nothing in 7.3.3.2 about linkage between the PFMEA and the control plan (although linkage is generally expected).

What's the relationship between FIFO and stacking of pallets?

Re: PFMEA and Control Plan connections

For Linkage try this:
line PFMEA CP
90 overstack overstack
100 FIFO FIFO
Typically what the auditor in TS is looking for is correlation from your PFD to PFMEA to CP.
If overstack is a concern in your PFMEA, it should be a concern in your control plan. Same with FIFO

Re: PFMEA and Control Plan connections

This was our surveillance audit to TS with a new auditor. The finding went specifically like this:
Finding:
The PFMEA anc Control Plan system is not fully effective.
ISO/TS 16949 Section:
7.3.3.2 Manufacturing process design output. The manufacturing process design output shall be expressed in terms that can be verified against manufacturing process design input requirements and validated. The manufacturing process design output shall include: specifications and drawings, manufacturing process flow chart/layout, manufacturing process FMEAs, control plan (see 7.5.1.1), work instructions, process approval acceptance criteria, data for quality, reliability, maintainability and measurability, results of error-proofing activities, as appropriate, and methods of rapid detection and feedback of product/manufacturing process nonconformities.
Description of Objective Evidence:
The PFMEA in line 90 cites overstacking, while the control plan for the same part does not cite overstacking. The control plan for the same part in line 90 states FIFO, but the PFMEA for the same part does not state FIFO.

Re: PFMEA and Control Plan connections

I have attached an excel file with the Control Plan, Process Flow, and PFMEA containing just that one step as the auditor saw it.

Re: PFMEA and Control Plan connections

atlantisind said:

This was our surveillance audit to TS with a new auditor. The finding went specifically like this:
Finding:
The PFMEA anc Control Plan system is not fully effective.
ISO/TS 16949 Section:
7.3.3.2 Manufacturing process design output. The manufacturing process design output shall be expressed in terms that can be verified against manufacturing process design input requirements and validated. The manufacturing process design output shall include: specifications and drawings, manufacturing process flow chart/layout, manufacturing process FMEAs, control plan (see 7.5.1.1), work instructions, process approval acceptance criteria, data for quality, reliability, maintainability and measurability, results of error-proofing activities, as appropriate, and methods of rapid detection and feedback of product/manufacturing process nonconformities.
Description of Objective Evidence:
The PFMEA in line 90 cites overstacking, while the control plan for the same part does not cite overstacking. The control plan for the same part in line 90 states FIFO, but the PFMEA for the same part does not state FIFO.

Click to expand...

This ncn is very enigmatic.
I do not know if I understood well from what I have seen in the file attached, but probably FIFO in CP is not so clear. If overstaking has not been considered as an issue in FMEA, you should not need any control in CP.

Re: PFMEA and Control Plan connections

atlantisind said:

I have attached an excel file with the Control Plan, Process Flow, and PFMEA containing just that one step as the auditor saw it.

Click to expand...

Your PFD and control plan show sequence #110 as "Ship" while the part of the PFMEA you posted doesn't show a sequence #110; it shows #90 as "Store final product." There certainly seems to be a mismatch. I'm not quite sure what's going on. There are times when in the PFD and PFMEA there might be operations 1,2,3 and 4 (for example) but only 1, 2 and 4 on the control plan. When such is the case, you should be able to tell from the PFMEA why #3 wasn't addressed on the control plan.

In your case, there are mismatched sequence numbers which make it appear that you store the product (#110) after you ship it (#90) which seems an unlikely sequence of events.

atlantisind said:

I am struggling with a recent audit finding...

The PFMEA and Control Plan system is not fully effective.
"Per 7.3.3.2, the PFMEA in line 90 states overstacking of pallets (under potential cause of failure) while the control plan, line 90 (under Product/Process/Specification/Tolerance) states FIFO.

So to correct this, the "Current Process Control" (Prevention or Detection, whichever fits best) now lists the "Process" from the Control Plan to tie the two documents together.

I am not sure if I am fixing this correctly because my Control Plan still says FIFO and my PFMEA still says Overstacking.

Click to expand...

You may want to look at your FMEA. "SP-19a Warehouse Inspection" is listed as a prevention control. Inspection is per definition not a prevention control. It should be listed under "detection control."

Just some feedback.

Stijloor.

I guess, in the end, what I really don't understand is how I am supposed to tie these two documents together other than as I have been doing by just making sure the same steps are in both.

atlantisind said:

I guess, in the end, what I really don't understand is how I am supposed to tie these two documents together other than as I have been doing by just making sure the same steps are in both.

Click to expand...

Have you been trained in the AIAG Core Tools such as APQP, FMEA, and Control Plan Development?
There is a logic sequence behind all this.

Stijloor.