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IATF 16949 Cl. 4.4.1.2 - Product Safety - How to interpret

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A

ashepherd

#12
So for product safety, we would ID safety items from inputs such as customer drawings, DFMEA review and perhaps an annual statutory & regulatory review. We would look to review this information during design & development planning to identify applicable safety characteristics, cascade this down to our supply base, ensure they confirm products they supply meet requirements (likely during PPAP process to us), maintain this documented information as evidence of conformity. We would then request annual submissions for flammability for instance as ongoing conformity.

Would this necessarily require the update of all older legacy control plans and FMEA we have internally to be updated for either special characteristic ID (if missing) and/or continuing conformance (annual activity). Our plan is to implement this on new programs moving forward and any high volume/impact products we currently have, but do not intend to do all 300ish active sets of documents.

Is this the similar path others have taken when dealing with regulatory and statutory items along with annual ongoing compliance submission 8.4.2.2 & 8.4.2.5?

Would you also consider flash on a vehicle exterior molded part as a safety characteristic? Part is chrome plated, so could be sharp metal edge. It could possibly (provided it's out of specification) cause cuts to end users hands during installation perhaps. Would this be severe enough to warrant it being identified as a safety characteristic.

How have others approached the training portion of this clause?

Thanks for your discussion.

Aaron
 

Golfman25

Trusted Information Resource
#13
So for product safety, we would ID safety items from inputs such as customer drawings, DFMEA review and perhaps an annual statutory & regulatory review. We would look to review this information during design & development planning to identify applicable safety characteristics, cascade this down to our supply base, ensure they confirm products they supply meet requirements (likely during PPAP process to us), maintain this documented information as evidence of conformity. We would then request annual submissions for flammability for instance as ongoing conformity.

Would this necessarily require the update of all older legacy control plans and FMEA we have internally to be updated for either special characteristic ID (if missing) and/or continuing conformance (annual activity). Our plan is to implement this on new programs moving forward and any high volume/impact products we currently have, but do not intend to do all 300ish active sets of documents.

Is this the similar path others have taken when dealing with regulatory and statutory items along with annual ongoing compliance submission 8.4.2.2 & 8.4.2.5?

Would you also consider flash on a vehicle exterior molded part as a safety characteristic? Part is chrome plated, so could be sharp metal edge. It could possibly (provided it's out of specification) cause cuts to end users hands during installation perhaps. Would this be severe enough to warrant it being identified as a safety characteristic.

How have others approached the training portion of this clause?

Thanks for your discussion.

Aaron
I would try to avoid updating all your legacy docs. Seems like you have a good plan. But may ultimately depend on your customer and/or auditor.

As for the safety item I think they are getting at auto safety. So things like brake systems, air bags, seat belts, etc. I don't think your sharp edge would qualify.
 

delorfra

Involved In Discussions
#14
Hello there,

FYI, the IATF 16949 FAQ No.4 states that this requirement is not only limited to regulatory/statutory requirements.

QUESTION:
What is the scope of this clause? Many organizations focus on regulatory/statutory requirements of the product and do not believe they have product safety related manufacturing product or processes.

ANSWER:
This clause focuses on product and manufacturing process characteristics that affect the safety performance of the final assembly. These characteristics may not be directly addressed in regulatory/statutory requirements, but may be defined by the customer.

http://www.iatfglobaloversight.org/...9-Frequently-Asked-Questions_October-2017.pdf

Francois
 
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