IATF 16949 Product Safety

J

jpj1474

#1
Hello,

I am new at creating documents and Iam very lost. We are being audited to the new standard and we do not have a Product Safety procedure written. Because of the nature of our business, we do not have any products that fall in this category at the moment. Does anyone have a procedure we could use and modify?
:cfingers:
Best,
JJ
 
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Marc

Fully vaccinated are you?
Staff member
Admin
#2
I don't have a procedure, but the APQP process requires a design FMEA. Your design FMEA should address all product safety related aspects of your product.

It seems to me if you write a procedure to address product safety it would be part of your DFMEA process.
 

Golfman25

Trusted Information Resource
#4
Following up on Marc's idea. You have to do feasibility reviews. Put a safety review in there. For you, it will be not applicable. But you have to show you covered it if it every become applicable. If it ever do a safety product, you should have it covered.
 

howste

Thaumaturge
Super Moderator
#5
Product safety starts with design, but products can be unsafe if they aren't manufactured to the specifications. With the PFMEA you may identify characteristics with higher severity rankings. You will also specify controls that will help to ensure that unsafe product doesn't make it to your customer. A cup holder may not be identified as a safety item but if it's shipped with a sharp edge it will be a safety issue.
 

Marc

Fully vaccinated are you?
Staff member
Admin
#6
True - The APQP process is supposed to take the design FMEA as inputs to the process FMEA.

I know the reality is it is common for a company not to have a design FMEA. It is also typically, especially for a tier 2, to be able to get a design FMEA from their customer, impossible.

But in the ideal... E.g.: Relationships of Automotive FMEAs
 

Golfman25

Trusted Information Resource
#7
Product safety starts with design, but products can be unsafe if they aren't manufactured to the specifications. With the PFMEA you may identify characteristics with higher severity rankings. You will also specify controls that will help to ensure that unsafe product doesn't make it to your customer. A cup holder may not be identified as a safety item but if it's shipped with a sharp edge it will be a safety issue.
Yes, but I think what IATF is really talking about is product safety concerns -- air bags (who can forget the air bag issues), brakes, seat belts, and the like.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#8
Because of the nature of our business, we do not have any products that fall in this category at the moment. Does anyone have a procedure we could use and modify?
What category are you referring to?

Keep in mind the IATF standard requires a documented process, which is different from a procedure. A documented process implies you define the process first and document it later. If you start with someone’s else procedure, even if you adapt it, it won’t reflect something that represents your product safety risks.

Also, be aware, this issue has been discussed a number of times, here; if you scroll down the page, you will see a section titled similar discussion threads.
 
C

cpearison

#9
R

Ripitup65

#10
Procedure for 'Product Safety' may not be a requirement, but having a documented 'Product Safety' process is a mandatory requirement. I'm looking to have it documented in a Turtle Diagram.
 
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