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TS-16949 and traceability

Discussion in 'IATF 16949:2016 - Automotive Quality Systems' started by Dave Mahon, Sep 9, 2015.

  1. Dave Mahon

    Dave Mahon Member

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    So we’ve had some debate recently at the company I work for. It’s about traceability. I was doing an internal audit and found we were not keeping traceability on O-Rings. We make tube and hose assemblies and the O-Rings are critical to keeping a good seal. TS-16949 says, “Where traceability is a requirement, the organization shall control the unique identification of the product and maintain records.”

    My interpretation of the intent of the standard that if a material failure occurs, traceability is used to track back and find all that material. The general consensus here is that only metal components require traceability, and our local procedures were written to say that.

    I’d say that any material failure that can affect form, fit, or function should have treaceability requirements.

    Any thoughts?
     
  2. David Bradley

    David Bradley Active Member

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    There is a significant difference in what we as auditors think and what is a requirement. The question is whether traceability is a requirement. This could come from 3 sources. There may be a statutory or regulatory requirement, a customer requirement or a company requirement. If none of those 3 mandates traceability, then it is not required. As an auditor, I would determine if it is actually mandated. If not and it sounds like it should be (your argument is a good argument), then I would write an opportunity for improvement or preventive action to have the company look into the o-rings to determine if it would be in the company's best interest to have an internal requirement for traceability... My 2 cents, anyways
     
  3. MCW8888

    MCW8888 Well-Known Member

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    I agree with David Bradley. I came across that same situation during the surveillance audit where traceability has not been a company requirement nor customer specific requirement.
     
  4. Dave Mahon

    Dave Mahon Member

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    It’s interesting………I went and got the supplier quality manuals for the customers with which I had traceability issues. Here’s what the first says………..

    Suppliers are expected to have controls in place3 to provide traceability through their process, from raw materials to the finished end product at the OEM. Each shipment to _________ must be identified to provide lot traceability in the event of a quality spill.

    Here’s what the second says………

    LOT TRACEABLITY

    Guidance: Traceability should be optimized to limit the size of product recalls and facilitate the expertise and analysis of root cause. General requirements for all parts: All suppliers shall have an effective lot definition and traceability procedure based on risk analysis. Suppliers shall ensure that their lot traceability system maintains its integrity through all the supply chain, including not only raw material, but also purchased components/products, sub contracted operations if any.

    So while each customer requires a traceability system, they do not not specifically say each component of an assembly requires traceability. If you take into account the mentioning of “risk assessment” a good argument could be made that O-Ring failure would result in complete part failure……so?
     
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  5. Candi1024

    Candi1024 Well-Known Member

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    Risk assesment could also refer to the recovery actions required if there were systematic O-ring failures. With good tracability, you can recall anything from a single part, to a full lot. Or, with no traceability, perhaps the remedial action is to send all customers new O-rings. Would these O-rings be easy to change?

    In the scope of a part failure risk assesement, I would think there would be two possibilites, leakage or complete failure of the seal which would completely dump all fluids. If it only dripped, would it drip on a hot engine, causing an explosion? If it completely dumped the fluids, would all braking power be lost?

    Or maybe the air conditioner just stops working so well, or not at all.

    Are the O-rings made of a special compound that is difficult to manufacture? = higher risk
    Are they made of a more common, very durable, easy to manufacture reliable material? = lower risk


    On another note, I am missing the spell check button, or do we not have one?
     
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  6. Hansraj Sharma

    Hansraj Sharma Member

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    F

    For automotive parts traceability must be kept irrespective of regulatory or customers requirement.
     
  7. Rich008

    Rich008 Member

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    All good points.
    If I was you I would think about... how many O rings do you get in a delivery and how long do they last?
    If one delivery lasts 6 months vs. 1 week you would need to control it differently.
    How many have failed in the field (FMEA)...

    When you have the information, think about talk to your customer.
     
  8. David Bradley

    David Bradley Active Member

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    Where exactly is the requirement for your statement? If it is not a regulatory or customer requirement, where is the requirement? The portion of TS that mentions traceability begins with "Where traceability is a requirement..."
     
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