When to update a PFMEA (Process FMEA)

J

jkittle

How far do you take updating PFMEA's?

I was written up by our register for "The APQP process is not effective at ensuring that PFMEAs are updated as new failure modes are identified and actions to reduce RPNs are taken."

I had the three customer complaints out of 20 that for 2007 that I did not update the PFMEA. My reasoning was that they were not new failure modes and I did not make any process changes. These were operator issues that they did follow existing procedures. Yes the root cause lies mostly in an ineffective training program.

Do you have to address the PFMEA on every customer failure and how do you address something that is a training issues with an occurrence of 1?
 

Kales Veggie

People: The Vital Few
Re: When to update a PFMEA

My first impression is that the registrar interprets the standard too tight.

What clause and what evidence is cited for the write-up?
 
J

jkittle

Re: When to update a PFMEA

Element/Procedure Reference:
ISO/TS 16949 Clause 7.1.4 and 7.3.1.1
Below is the actual write up.

Description of Nonconformance, Requirement and Objective Evidence: "The APQP process is not effective at ensuring that PFMEAs are updated as new failure modes are identified and actions to reduce RPNs are taken."


Requirement: (The standard requires or their procedures/work instructions/Level 1/Level 2required and was not followed)

The organization shall develop and review PFMEAs. The organization shall have a change control process and changes shall be verified and validated before implementation.

The PFMEA for part numbers ABC/EFG has not been updated to include recent failure modes identified in addressing DCARs (cutomer complaints) and actions taken to reduce RPNs.
 
D

David DeLong

Re: When to update a PFMEA

Yes the Process FMEA should be updated on all customer complaints but it is only clerical.

Your 8D or Corrective Action system will drive your customer complaint but make sure that the new failure mode is now in your Process FMEA. Should one get the team together (assuming you really did a proper FMEA during process development)? Probably not. This is a clerical situation and the only people who would be interested in the revised P FMEA would be the 3rd party auditor.

Sometimes it can be discouraging putting on a show but it is part of the "game" especially in automotive.
 
D

Duke Okes

Re: When to update a PFMEA

Element/Procedure Reference:
ISO/TS 16949 Clause 7.1.4 and 7.3.1.1
Below is the actual write up.
Description of Nonconformance, Requirement and Objective Evidence: "The APQP process is not effective at ensuring that PFMEAs are updated as new failure modes are identified and actions to reduce RPNs are taken."
Requirement: (The standard requires or their procedures/work instructions/Level 1/Level 2required and was not followed)
The organization shall develop and review PFMEAs. The organization shall have a change control process and changes shall be verified and validated before implementation.
The PFMEA for part numbers ABC/EFG has not been updated to include recent failure modes identified in addressing DCARs (cutomer complaints) and actions taken to reduce RPNs.

This is not an adequate NC since there is no specific traceable evidence provided (e.g., which DCARs was PFMEA not updated?).

You might consider updating your CAR form to include something like "FMEA need updating?" to show when you do and don't consider it appropriate.

Chances are the auditor is being nitpicky, but without actual evidence hard to know.
 
B

Bigfoot

Re: When to update a PFMEA

This is not an adequate NC since there is no specific traceable evidence provided (e.g., which DCARs was PFMEA not updated?).

You might consider updating your CAR form to include something like "FMEA need updating?" to show when you do and don't consider it appropriate.

Chances are the auditor is being nitpicky, but without actual evidence hard to know.

:agree1: I agree with what the others have said here. Tying the P FMEA "REVIEW" into the CAR form is a good trigger / reminder that it gets reviewed and updated, even if it is the clerical update Dave referenced.
 

Stijloor

Leader
Super Moderator
How far do you take updating PFMEA's?

I was written up by our register for "The APQP process is not effective at ensuring that PFMEAs are updated as new failure modes are identified and actions to reduce RPNs are taken."

I had the three customer complaints out of 20 that for 2007 that I did not update the PFMEA. My reasoning was that they were not new failure modes and I did not make any process changes. These were operator issues that they did follow existing procedures. Yes the root cause lies mostly in an ineffective training program.

Do you have to address the PFMEA on every customer failure and how do you address something that is a training issues with an occurrence of 1?

Hi Jerry,

The PFMEA is a "living" document and should reflect the "current state of process affairs." That means that if new (significant) failure modes are discovered, they should be included in the PFMEA record. Also, as significant improvements have been realized (the process is becoming more robust), then the PFMEA should be updated as well. Your challenge is now to upgrade your PFMEA development process to incorporate such changes.

You should also develop criteria for what "significant" means for your organization. Be realistic about it and don't do this to satisfy the wishes/expectations of the auditor. Make it work for you! :yes:

Hope this helps.

Stijloor.
 

Jim Wynne

Leader
Admin
Yes the Process FMEA should be updated on all customer complaints but it is only clerical.

The PFMEA is a "living" document and should reflect the "current state of process affairs." That means that if new (significant) failure modes are discovered, they should be included in the PFMEA record.

Here's what the OP said, with my emphasis:
I had the three customer complaints out of 20 that for 2007 that I did not update the PFMEA. My reasoning was that they were not new failure modes and I did not make any process changes.

There's no point in "updating" something with information it already contains. The fact that the OP had 20 issues and did update PFMEAs for 17 of them indicates that (A) this is not a systemic issue, and (B) the OP understands the requirements and (C) the auditor apparently doesn't.
 

Helmut Jilling

Auditor / Consultant
Here's what the OP said, with my emphasis:


There's no point in "updating" something with information it already contains. The fact that the OP had 20 issues and did update PFMEAs for 17 of them indicates that (A) this is not a systemic issue, and (B) the OP understands the requirements and (C) the auditor apparently doesn't.


I fully agree. I am frankly surprised that 17 of 20 resulted in a PFMEA update. The PFMEA should be considered, but updates are only required when there is some information that needs to be changed. Perhaps the OP should ask the auditor what information inparticular should be changed. If he has a good answer, then perhaps a change is warrated. If not, it should shut down the discussion.
 
J

jkittle

Thanks to all for your replies.

I think you all hit on what I'm felling as well, that the P FMEA should be updated when important changes are needed and not just a clerical thing.
If I've made no process changes or amendments to existing procedures or work instructions and the failure lies with an operator failure regardless if the operator failure is due to poor training I see no need to update the P FMEA.

I still struggle at times with the P FMEA. I look at the P FMEA as a way of identifying potentials failures with machine process parameters or subsequent operations during the manufacturing process.

The other example that the auditor found was a customer requested change to a dimension a on a part to bring it closer to nominal. The change caused another dimension to go out of spec that did not get evaluated at the new PPAP because no one knew the change would have an adverse affect on that feature. This lead to a non-usable part (customer complaint). We looked at the failure as a design issue. The design team did communicate to a quality lab all the potential changes that could have occurred so the lab did measure this feature. We now use a form that comes from Engineering that when mold changes are done the Engineering group based on the change will know what features cold be changed and the lab is verify all before PPAP.

How does this go into a P FMEA? I look at this a more of a system failure and not a process failure that goes into a P FMEA.
 
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