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Questions about 4.4.1.2 Product Safety clause

Discussion in 'IATF 16949:2016 - Automotive Quality Systems' started by SzKiss, Feb 11, 2023.

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  1. SzKiss

    SzKiss New Member

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    Hi,

    I'm new here, I've been working as an engineer for years but lately I've been tasked with managing an organizations QMS, I am not clueless however some clauses are hard for me to understand, the one I have to most problems with is the Product Safety as it seems a bit vague.

    What I do not understand is:
    -how am I exactly supposed to acquire all the regulations and laws from all the countries the vehicles will ever be driven, where it is manufactured, and where it will be shipped through? This seems a bit daunting
    -special approvals needs to be acquired for design FMEAs, process FMEAs and CPs, but in the SI the standard says "may be required by customer or internal processes". I know that it is really important to understand the exact phrasing, but based on that, since it was not mentioned as "shall" is it viable to say that the organization chose to ignore this?
    -it is implied that the reactions plans are required to be defined in documentation, with escalation, responsibilites and correct information relay? So are reaction plans a necessary record?
     
    SzKiss, Feb 11, 2023
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  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Welcome. Before we can really help you, we need to know the scope of your QMS and hence, the impacts of the safety requirements on your organization.
     
    Andy Nichols, Feb 11, 2023
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  3. SzKiss

    SzKiss New Member

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    Sure, I apologize.

    We are a european producing factory with suppliers mainly from the European Union, we ship to tier 1 automotive part companies world-wide. Our QMS includes all external services and is responsible to the products up to its usage at the customer. We are making plastic injection molded parts.
     
    SzKiss, Feb 12, 2023
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  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Your scope is injection moulded plastic parts? You do not do product design? Does your customer identify safety critical features on their drawings?
     
    Andy Nichols, Feb 12, 2023
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  5. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Welcome SzKiss,

    Your specific customer requirements should be made available too you. if they are not, you lack the basis for understanding what is required. Customers will call out a requirement to conform with XYZ regulation, engineering guideline/standard like ASTM, testing requirements, packaging requirements, cleanliness requirements, material requirements - everything. This sort of thing should be documented, and not left for you to guess. Ask your management. if they decline to provide this information, I suggest you respectfully decline to perform responsibilities in QA because you really do need to know what requirements you are being held to before starting the effort of doing so.
     
    Jennifer Kirley, Feb 13, 2023
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