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

[qusys]

Could you share your thoughts how to meet this requirement?

If the customer does not communicate anything about product safety, how to proceed?

How to proceed to identify regulatory and statutory requirements in a manufacturing site ( no product design) for electronic devices production for the automotive market?

Thanks

 

[Sipes2]

we will be showing ours in the early design as part of a gate sign off... along with critical characteristic's... not much help.. but we have nothing that is a safety issue, so it is just a nod toward that...

 

[qusys]

we will be showing ours in the early design as part of a gate sign off... along with critical characteristic's... not much help.. but we have nothing that is a safety issue, so it is just a nod toward that...

What did you intend for "product safety"?

 

[Sebastian]

From process design team perspective, it may start like this:
1. Review of product specification (e.g. drawings) to potentially find marked by designer (or customer) special characteristics affecting safety.
2. Review of DFMEA to learn functionality of product and potential impact on safety.
3. Identify potential regulatory and statutory requirements affecting safety and reviewing them.
4. Creating PFMEA where impact of product failure on final user is recognized and potentially impact on her(his) safety is to be determined, with inputs from previous points.
No characteristics, no impact determined. Finish.

As auditor I would concentrate on reviewing PFMEA column "Potential Effect(s) of Failure". If I see, there was considered impact on user, but described in more detailed manner than "user dissatisfied", e.g. "user can not do ..." it would be for me evidence, that organization posses enough knowledge regarding what is function of product they manufacture, what is going on with car (user) when it fails.

 

[qusys]

From process design team perspective, it may start like this:
1. Review of product specification (e.g. drawings) to potentially find marked by designer (or customer) special characteristics affecting safety.
2. Review of DFMEA to learn functionality of product and potential impact on safety.
3. Identify potential regulatory and statutory requirements affecting safety and reviewing them.
4. Creating PFMEA where impact of product failure on final user is recognized and potentially impact on her(his) safety is to be determined, with inputs from previous points.
No characteristics, no impact determined. Finish.

As auditor I would concentrate on reviewing PFMEA column "Potential Effect(s) of Failure". If I see, there was considered impact on user, but described in more detailed manner than "user dissatisfied", e.g. "user can not do ..." it would be for me evidence, that organization posses enough knowledge regarding what is function of product they manufacture, what is going on with car (user) when it fails.

It could be difficult to apply this for a mfg site with no product design and at level 3 in automotive chain, given that there is no visibility on end user. Design fmea is done by direct customer . There is no communication about product safety about clause b)

 

[Sebastian]

No product design = no DFMEA = no knowledge where our product seats?
We are not automotive to be passive.
There is requirement stating we must know and there is a lot possibilities to get what we have to know.
b) direction is from organization to customer, sorry.

I've already said "If it is hard, does not mean not applicable."

 

[qusys]

No product design = no DFMEA = no knowledge where our product seats?
We are not automotive to be passive.
There is requirement stating we must know and there is a lot possibilities to get what we have to know.
b) direction is from organization to customer, sorry.

I've already said "If it is hard, does not mean not applicable."

I know the requirement, but in a tier 3 level, it's hard to establish it in the process, when the device will be part of a system that will be part of another system in the car.

 

[Sebastian]

I know even EOMs are not supportive, because we have also there "accidental" people - no automotive education, not keen on cars, but I do not like "give me, give me" attitude. Maybe I expect too much.

E-mail your customer and ask. Make private investigation what they produce, who they supply. Make some friends in dealer's service department, find your part in car. Read automotive newspapers, look for car "exploded views", maybe you will find your part. You still do not know nothing. Ok, at least you've tried. For me it is ok.

 

[Golfman25]

I know the requirement, but in a tier 3 level, it's hard to establish it in the process, when the device will be part of a system that will be part of another system in the car.

I agree with you. Check your customers supplier manual. A lot have special print designations for safety related items that even your customer reps won't be aware of.

 

[jfries2]

Any product characteristic that impacts product safety should be designated as such on the drawing by special symbol. And, if you are not clear on the meaning of the symbols, as already mentioned, refer to the customer SQAM.