Most appropriate Auditor to check the FMEA & PCP of a Manufacturing Process

L

luis.armendariz

#1
Who is the most appropiate auditor to check the FMEA and PCP of a manufacturing process?
The one responsible to audit the manufacturing process or the one responsible to audit APQP process?

Thanks
 
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D

DRAMMAN

#2
Either...as long as they understand PPAPs and FMEA's. And of course are good auditors. From an ISO perspective you would want the auditor independent of the people who created and have responsibility for the documents.
 

qusys

Trusted Information Resource
#3
Who is the most appropiate auditor to check the FMEA and PCP of a manufacturing process?
The one responsible to audit the manufacturing process or the one responsible to audit APQP process?

Thanks
Auditing is based on sample. You can audit FMEA and CP in both the internal audits. It depends on the scope and criteria of the audit.
You may have many PFMEA's and CP's so in both audit you can sample different of them based upon the product family.
The important is the auditors are competent in management system audit.
Hope this helps:bigwave:
 
D

DRAMMAN

#4
You also have ot ask yourself what about the FMEA and CP are you auditing. Are you auditiing that they exist or are you auditing the quality of the content. I have seen plenty of FMEA's and CP's that "meet requirements" but are really nothing more than a piece of paper to present to customers when they visit. What I look for is if the FMEA's and CP's are living documents with frequent revisions and updates? Do operators know and understand the documents or do they only sit in the quality department files? Does every FMEA and control look identicle? Being able to evaluate these aspects of the documents requires experience.
 
L

luis.armendariz

#5
Ok, based on your comments I believe the most appropiate is the one auditing the manufacturing process since he/she must review in detail the manufacturing process, while the one auditing APQP must make sure only all documentation and APQP process is being followed among other activities, this way we will not duplicate activities.

Thanks all for your help
 
#6
Either...as long as they understand PPAPs and FMEA's. And of course are good auditors. From an ISO perspective you would want the auditor independent of the people who created and have responsibility for the documents.
From an ISO perspective, they just can't audit their own work! The idea of independence shouldn't prevent someone who knows the actual practices from auditing them. Indeed, you WANT an internal auditor to be familiar with a process, tools etc. since otherwise, they can be totally lost when they're being shown what happens.

If you've ever tried to play an instrument or have someone explain how to do that you'll understand what I mean.
 
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