Introducing an existing product into automotive context - DFMEA needed?

Dan M

Involved In Discussions
#1
Hi, we have products (fluids) that were designed years ago, that are now being introduced into OEM Automotive applications. The products were originally designed for non-automotive applications, so the design work was done according the ISO 9001 guidelines.

Will an auditor have the expectation that the design documentation needs to be updated to meet the guidelines of IATF 16949 8.3 For example, some products may not have a DFMEA. Thanks for your support?
 
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Sidney Vianna

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#2
Is the automotive application subject to (customer driven) new requirements? Do you have new parameters to validate? Are there new product regulatory requirements for you to assess the product against?

In my experience, auditors are willing to accept previous approval packages, if well documented. But, normally there are deltas to be covered.
 

Dan M

Involved In Discussions
#3
The products are validated against the new customer and regulatory requirements. Although we did construct a PFMEA, I think our main concern is that we do not have a DMFEA.
 

Sidney Vianna

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#4
So, it looks like you will have to develop a DFMEA in order to comply with the IATF 16949:2016 requirements.

Any IATF competent auditor would expect to see it.
 

Sidney Vianna

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#6
A lot of things can change because of the new application, including the severity of the failure. Without knowing the specifics of the original and new applications, we would be just speculating.

Automotive quality has improved immensely in the last 30 years. While some suppliers like to badmouth the OEM requirements and paint everything with the wide brush of unnecessary bureaucracy, it seems to me that, collectively, the automotive industry is making great progress in terms of product quality. So, I believe, the tools they use must be helping.
 
#8
I have a similar question.

We are designing a product(under ISO 9001), but have interest from customers to make it automotive. All of our manufacturers will be TS 16949, but we as a "design house" are still only ISO 9001.

It seems the Automotive companies appear to be interested in us providing APQP, PPAP, DFMEA and PFMEA's.

If I understand correctly the DFMEA & PFMEA are part of the FMEA package, which is part of a PPAP?

Where does APQP play into this? Is this simply AIAG's version of PPAP?
 

Golfman25

Trusted Information Resource
#9
I have a similar question.

We are designing a product(under ISO 9001), but have interest from customers to make it automotive. All of our manufacturers will be TS 16949, but we as a "design house" are still only ISO 9001.

It seems the Automotive companies appear to be interested in us providing APQP, PPAP, DFMEA and PFMEA's.

If I understand correctly the DFMEA & PFMEA are part of the FMEA package, which is part of a PPAP?

Where does APQP play into this? Is this simply AIAG's version of PPAP?
Get the core tools reference books from Aiag. But apqp essentially includes all the ppap elements.
 
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