IATF 16949 - Manufacturing and Product Audit Approach

[santiko]

Hi all,

In IATF 16949 the requirement state

9.2.2.3 Manufacturing process audit
The organization shall audit all manufacturing processes over each three-year calender period to determine their effectiveness and efficiency using customer-specific required approaches for process audit. Where not defined by the customer, the organization shall determine the approach to be used
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9.2.2.4 Product audit
The organization shall audit products using customer-specific required approaches at appropriate stages of production and delivery to verify conformity to specific requirements. Where not defined by the customer, the organization shall define the approach to be used

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Our customer not defined the audit approach. My question is What kind of approach our organization need to be defined for each type of audit? Or how we should implement this "shall" in our organization?

Thank you in advance.

 

[Golfman25]

So I look at it this way:

Product audit is the old dock audit. We take a part sitting on our dock ready for shipment and check it for compliance to customer requirements. We have a simple checklist form we use.

Manufacturing process audit we hit two ways: First is basically a part audit to the control plan. We follow all the way thru from purchasing to final inspection. Again we have a checklist we use.

Then we also do a global system audit of our manufacturing processes/procedures. This is less part specific and more of an overall view.

 

[oldhouse]

Then we also do a global system audit of our manufacturing processes/procedures. This is less part specific and more of an overall view.

Do you have a template where you report system audit results?

 

[Golfman25]

Do you have a template where you report system audit results?

No. This is more of an open ended type of audit.

 

[joekirk]

Product audits could be the old dock audits, but it could also be in-process audits done on a regular basis at various inspection points in your process. Most companies are already doing this.

Manufacturing process audits should be looking at the control plan, FMEA and procedures, past corrective actions and customer complaints associated with the process being audited. This should be used to make sure your FMEA, CP and procedures are current.

 

[Marc]

Good points, joekirk. None of this is really "new". It reminds me of the old "Dragnet" disclaimer: "Only the words were changed to confuse people".

 

[santiko]

Product audits could be the old dock audits, but it could also be in-process audits done on a regular basis at various inspection points in your process. Most companies are already doing this.

Manufacturing process audits should be looking at the control plan, FMEA and procedures, past corrective actions and customer complaints associated with the process being audited. This should be used to make sure your FMEA, CP and procedures are current.

Good points, joekirk. None of this is really "new". It reminds me of the old "Dragnet" disclaimer: "Only the words were changed to confuse people".

Thanks for the feedback.

Yes, i understand the audit approach is should be like that like the old one. But, what i mean is, how i put it on our procedure.

"Where not defined by the customer, the organization shall determine the approach to be used"

replace with,

"Where not defined by the customer, the organization shall be looking at the control plan, FMEA and procedures, past corrective actions and customer complaints associated with the process being audited"

is something like that? do you all agree?

 

[Marc]

I think that's pretty much it. Remember - Don't over think this stuff.

 

[mgucia]

You can find strict guidelines for both audits in publications of german VDA:
"VDA 6.3 Process audit"
"VDA 6.5 Product audit"

Draft of "VDA 6.3 Process audit" is available online.

In attachment B to IATF you can find list of suggested "approaches"

Internal audit
AIAG
CQI-8 Layered Process Audit
CQI-9 Special Process: Heat Treatment System Assessment
CQI-11 Special Process: Plating System Assessment
CQI-12 Special Process: Coating System Assessment
CQI-15 Special Process: Welding System Assessment
CQI-17 Special Process: Soldering System Assessment
CQI-23 Special Process: Molding System Assessment
CQI-27 Special Process: Casting System Assessment
ANFIA
AQ 008 Process Audit
FIEV
V2.0 Production Process Audit Manual
IATF
Auditor Guide for IATF 16949
VDA
Volume 6 part 3 Process Audit
Volume 6 part 5 Product Audit

 

[Mikey324]

If it helps, we changed very little about our I/A procedure. TS already required product, process, and system audits.

We really only looked through our competency requirements to make sure they met the requirements of 7.2.3 / 7.2.4 (see latest IATF sanctioned interpretations, this was clarified).

From 9.2.2.1, you are most likely already creating your schedule based on priority. Your priorities should already be risk based. Example, you will increase the frequency of audits if the process has let NG parts flow out. You would not increase the frequency for a process with little impact on the customer that has had no past corrective actions, audit findings, ect. This is already risk based thinking.

Some "new" requirements in the standard are not really new. Just the wording in my opinion.

For reference, we have completed our transition audit with no findings for the internal audit system. Trust me, they looked at it hard.