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PFMEA Review after complaint - Why and What For?

Peters

Quite Involved in Discussions
#1
Many automotive auditors say - firm have to do PFMEA update (or at least PFMEA review) after every customer complaint as a part of Corrective Actions Process.
My questions:
1.Why? What for? (FMEA is prevention tool, no reaction tool)
2.What is the real requirement? (I can't find it in ISO/TS 16949)
Can anybody help me?
 

Stijloor

Staff member
Super Moderator
#2
Re: PFMEA Review after complaint

Many automotive auditors say - firm have to do PFMEA update (or at least PFMEA review) after every customer complaint as a part of Corrective Actions Process.
My questions:
1.Why? What for? (FMEA is prevention tool, no reaction tool)
2.What is the real requirement? (I can't find it in ISO/TS 16949)
Can anybody help me?
Hello Peters,

The PFMEA (and also the DFMEA) records are "living" documents. That means that if new discoveries are made for the "good" or the "bad", we are expected to update the FMEA records. For example, if for some reason a flaw in the manufacturing process was discovered (a process failure mode), you are required to investigate why you failed to recognize this actual failure mode, and if significant, this failure mode must be added to the PFMEA record.

Also, if the process has become more robust ("better"), we are expected to reflect that on the PFMEA record as well; the ratings for occurrence and/or detection will become more favorable.

The term "living document" is used in the core tools. There is no specific requirement in ISO/TS, but FMEA record updates are expected.

Hope this helps.

Stijloor.
 

Jim Wynne

Super Moderator
#3
Re: PFMEA Review after complaint

Many automotive auditors say - firm have to do PFMEA update (or at least PFMEA review) after every customer complaint as a part of Corrective Actions Process.
My questions:
1.Why? What for? (FMEA is prevention tool, no reaction tool)
2.What is the real requirement? (I can't find it in ISO/TS 16949)
Can anybody help me?
Stijloor's provided a good answer, but I'm wondering about what you mean by "automotive auditors." The auditor(s) should have cited the requirement, and if it wasn't cited, you should ask the auditor(s).

As far as PFMEA being a prevention tool and not a reaction tool, the purpose of revisiting the record is to determine whether or not the current controls (as cited in the PFMEA document) are adequate, and whether or not prevention controls may be invoked. You should be using existing FMEA documents for information when you do new ones, so having a record that extends beyond the initial version of the document is important.
 

Peters

Quite Involved in Discussions
#4
Re: PFMEA Review after complaint

The PFMEA (and also the DFMEA) records are "living" documents.
You know... It's not argument for auditee.
During the audit we have dialogue:
Auditor: You have to update PFMEA
Auditee: Why?
Auditor: Because this is "living document"
Auditee: And what?... :notme:

That means that if new discoveries are made for the "good" or the "bad", we are expected to update the FMEA records. For example, if for some reason a flaw in the manufacturing process was discovered (a process failure mode), you are required to investigate why you failed to recognize this actual failure mode, and if significant, this failure mode must be added to the PFMEA record.
OK. After complaints we should ask ourselves - Why our PFMEA is so poor...
But it's not argument for PFMEA update.

The term "living document" is used in the core tools. There is no specific requirement in ISO/TS, but FMEA record updates are expected.
Yes. Maybe it's not good requirement but I'm sure it's good argument.

I'm wondering about what you mean by "automotive auditors."
My colleagues :lmao:

The auditor(s) should have cited the requirement, and if it wasn't cited, you should ask the auditor(s).
They say - "Corrective Action practice prescribe this". And this text doesn't persuade me.

As far as PFMEA being a prevention tool and not a reaction tool, the purpose of revisiting the record is to determine whether or not the current controls (as cited in the PFMEA document) are adequate, and whether or not prevention controls may be invoked. You should be using existing FMEA documents for information when you do new ones, so having a record that extends beyond the initial version of the document is important.
Agree.
For me the only argument for PFMEA update is: Firm should have up-to-date PFMEA when firm begin new product development.
 
D

Duke Okes

#5
If you have a customer complaint it is because either:

- one of your existing controls for prevention or detection did not work, and looking in the FMEA might help you know which ones to look for

- you didn't include the failure mode in your FMEA and it should be added

Either way, the process failed, and the idea of doing a pFMEA is to keep that from happening. So after doing a root cause analysis you should change the process to keep the problem from recurring, and when you change a process you are required to update the pFMEA (and control plan) to reflect the new process.
 
M

michael.witte

#6
We included updating FMEA as part of the 8D or corrective action process, in the preventative section (i.e. how do we prevent this problem from happening again in the future).

Slightly off topic.
 

Peters

Quite Involved in Discussions
#7
If you have a customer complaint it is because either:

- one of your existing controls for prevention or detection did not work, and looking in the FMEA might help you know which ones to look for

- you didn't include the failure mode in your FMEA and it should be added

Either way, the process failed, and the idea of doing a pFMEA is to keep that from happening. So after doing a root cause analysis you should change the process to keep the problem from recurring, and when you change a process you are required to update the pFMEA (and control plan) to reflect the new process.
I wonder...
I know - FMEA is "living document", but should FMEA be "living risk analysis"?
When we have real process in our production area - do we need risk analysis? Do we need risk analysis when almost everything is known? Everything is clear? Should we ask about the risk when we know the truth - we have failures, we have complaints and we know our situation. Corrective actions can improve the situation. So do we need new review of risk analysis?
 

Jim Wynne

Super Moderator
#8
I wonder...
I know - FMEA is "living document", but should FMEA be "living risk analysis"?
When we have real process in our production area - do we need risk analysis? Do we need risk analysis when almost everything is known? Everything is clear? Should we ask about the risk when we know the truth - we have failures, we have complaints and we know our situation. Corrective actions can improve the situation. So do we need new review of risk analysis?
Doing automotive work sometimes requires doing things that aren't necessary or prudent. The more you think about it and try to figure out why you're continually asked to waste money while your customers are dunning you for cost reductions, the more frustrated you'll become. Every once in a while you'll have a customer representative who's willing to listen to reason, but they're rare. You have to either learn to live with it, or find another line of work.
 
D

David DeLong

#9
Doing automotive work sometimes requires doing things that aren't necessary or prudent. The more you think about it and try to figure out why you're continually asked to waste money while your customers are dunning you for cost reductions, the more frustrated you'll become. Every once in a while you'll have a customer representative who's willing to listen to reason, but they're rare. You have to either learn to live with it, or find another line of work.
Right on Jim - I totally agree.

Updating you PFMEA is clerical since a company's corrective action (8 D) reflects short and long term approach to a Customer problem. Of course, we do have verification methods to confirm that the long term solution really works. Your corrective action system really drives this process.

There may be some value to the updated PFMEA but compared to a truly living document, your Control Plan, the benefits are quite small. One better have it done though prior to your 3rd party audit or else :(
 
#10
Hi,
Regarding the PFMEA:
1) related Clause in IATF16949:2016?
2) Frequency to review existing PFMEA?
3) Is necessary to update although it has NO changes in process/design, no customer claims &...?

Anybod can help me?
 


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