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IATF 16949 8.3 Exclusion - Manufacturing process design and development

#1
Good Morning,

I am in a new position with a company certified to the IATF 16949 standard. We have justifiably excluded section 8.3 since we do not design the products we sell. Our certificate states: “Clause 8.3 (product design) of IATF 16949:2016 is justifiably excluded.”

The previous QA manager didn't leave much in the way of registrar audit documentation so I cannot refer to these.

My questions center around: 4.3.1 “The only permitted exclusion for this Automotive QMS Standard relates to the product design and development….” And “Permitted exclusions do not include manufacturing process design.”

As I am preparing for a surveillance audit, I am wondering about the application of 8.3 for manufacturing process design. 8.3.3.2 and 8.3.5.2 have been addressed. But, because manufacturing process design is not excluded, do the following clauses then apply for manufacturing process design?

8.3.1.1
8.3.2.1
8.3.3.3
8.3.4.1
8.3.4.2
8.3.4.4
8.3.6
8.3.6.1

I am asking because even though product design and development is justifiably excluded, manufacturing process design and development is intertwined in these clauses and it seems there really isn’t much in the way of excluding a lot of section 8.3.

So for those that have excluded 8.3 product design, how have you handled this?

Thanks
 
#2
If you believe those clauses are relevant to manufacturing process design, then yes they need to be addressed. How? I haven't gotten there yet. :)
 

Mikey324

Involved In Discussions
#3
You really have to look at how these may apply to you. For Example:

8.3.1.1 - How was it determined that your processes were designed to do what you want them to?
8.3.2.1 - This would include your cross functional team for FMEA and Control Plan. Not just done by the quality person.
8.3.3.3 - the way your cross functional team determined and applied special characteristics. Again FMEA, control plans, check sheets, etc
8.3.4.1 - How do you measure the performance of your processes? Info from management review meetings.
8.3.4.2 - To me, this seems very geared toward product design. On the process side, how do you validate your process? Is it performing the way you want?
8.3.4.4 - Customer PPAP's
8.3.6 - For 8.3.6 and 8.3.6.1, think of how you control a change to your manufacturing processes. If you made a change, would you need customer approval? How would you make sure your product is just as good, or better, than before the change?


This is the way i think about these clauses and their application to the process design side of things. Worked for me so far.

Best of luck!
 
#4
Thank you, that makes sense.
I just wish I had reports from the last 2 registrar audits to see what they actually looked for in this section.
 
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