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Raw material traceability

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Jeff Myers, May 3, 2023.

  1. Jeff Myers

    Jeff Myers Member

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    We are a narrow fabric mill. We take thousands of pounds of yarn from many different lots and weave narrow tapes and ribbons. We are exploring ISO9001 for the purpose of becoming certified and one big area of pushback is when it comes to the traceability of yarn. Our weave department explains that there could be yarn from 4-5 lots in a single lot of tape woven and those lots of yarn could switch during a run due to the yarn lot sizes. What determines the requirement for traceability of raw materials in a finished goods? Is there a level of importance or a factor of the need to trace? The weave manager commented that "cotton 12/2 yarn is cotton 12/2 yarn" there is not much difference. My response was "that is true, there is not much difference until there is....". I would love to hear any thoughts and comments on this subject.
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Good question! There's a clue in the way the ISO requirement is worded... "when traceability is a requirement". You can decide that the product is almost impossible to trace, given multiple supply sources, mixing batches on hand etc. and hence, do nothing.
    Traceability is primarily to facilitate the lowest cost (risk) solution to defects being found some place in the supply chain, from your supplier to your customer (and beyond) - if deemed to be a consideration. If a defect is found, (in the market) what would be the action(s) taken to mitigate the situation? Pull all product? Simply replace it? As you suggest, it may not, in isolation, be thought of as a "big deal" now...
     
  3. Jeff Myers

    Jeff Myers Member

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    Andy, thank you for your reply. The risk is low since the rate of defective products and/or customer complaints is extremely low. If there were a problem simply replacing the goods would be the most efficient action to take and that would be whether yarn is traceable or not. And 99.9% of the time, the yarn is not the issue, it would be more likely to be a process or other component in which we do trace.

    Again, Andy, thank you! I am new to the standard and we are working to analyze the gap at this time. You have been a great help!
     
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  4. Miner

    Miner Moderator Staff Member

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    Fully agree with Andy's comment. Since you do traceability for the manufacturing process, be sure to stipulate what is in (manufacturing)/out (raw materials) of scope for your traceability program and the rationale behind it. Also, make sure that your current traceability works in both directions (i.e., if you have a field issue, can you trace it back to the manufacturing process that created it AND back out to any other customers that received product produced from the same causals).
     
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  5. Golfman25

    Golfman25 Well-Known Member

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    If you’re not doing traceability now, then it’s most likely not a requirement for your products. Unless you have a reason to change that, continue as normal. Not really an ISO thing. Real question is why are you considering 9001? Do your customers require it?
     
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  6. Miner

    Miner Moderator Staff Member

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    Or will it provide a competitive advantage?
     
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  7. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Clearly it is! 8.5.2 "Identification and traceability". What is Jeff to say when some lack-luster CB auditor asks him about traceability and he's left standing there looking like a deer in the headlights?

    He says they want to be certified. Having a QMS complying with ISO 9001 is a good thing to do for many reasons. Letting (potential) customers know through certification is another matter entirely and not always customer driven. We know that buyers are told by (supplier) QA folks to "buy from ISO certified suppliers" because it makes things somewhat easier than doing supplier development #askmehowIknow No-one in Sales will be against putting a copy of their certificate on the company website in a prominent position, so the buyer knows they can ask for a quote... It's a lot more effective than cold calling, trust me!
     
  8. Jeff Myers

    Jeff Myers Member

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    We are not doing traceability now on a number of raw materials and correct, it is not necessarily a requirement for our products, but it is however a required by ISO to some degree spelled out in 8.5.2. My core questions is to what degree to we track and trace raw materials and components? To your question of why.. None of our current customers require it but they do look for it and have a separate questionnaire for non-ISO companies. Also we feel as though it will help with potential customers when ISO9001 certification is a deal breaker. Also, increasing our awareness and attentiveness to quality can only help us in the long run.

    Thank you for your questions and thoughts.
     
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  9. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Nope, it simply says when traceability is a requirement. In some industries, it's a regulatory requirement (medical devices, chemicals, cars etc), or a customer requirement (steel used in parts which are machined and heat treated, for example) or the organization's own requirement to mitigate the costs of recalls or to permit serviceability/repair/warranty etc.

    To achieve ISO certification, you will simply take exception in your QMS scope "The manufacture of fabric tapes and ribbons" (Product design and material traceability are not applicable)
     
  10. Golfman25

    Golfman25 Well-Known Member

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    it is pretty clear only applicable where traceability is required. “Not required” would be a good response. It’s 2023. If they haven’t done traceability before now, I wouldn’t think it’s required. He’s allowing his fellow employees to object to something not even required in his circumstances. Doesn’t make for an easy implementation.
     
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  11. Jeff Myers

    Jeff Myers Member

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    I think I better understand your point now. Thank you for clarifying.
     
  12. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Jeff: Part of successful compliance and - sadly - passing an ISO audit is down to a couple of things:

    Knowing what ISO 9001:2015 actually states (I avoid "requires") and why, then

    What your organization's approach to compliance is.

    In this case, ISO doesn't "require" traceability. It states what you must do IF/WHEN traceability is a requirement. It states the organizations must control the unique identification and retain documented information to enable traceability (when traceability) is required. Simples. To be successful in any ISO audit, because many auditors don't ACTUALLY KNOW what the standard says, they simply audit by "gut feel" and something they see will trigger a question "Well, how do you know it's traceable" and no-one knows how to reply...

    Actually, this is why doing a number of internal audits to check on the approach and also prepare people is so important...
     
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  13. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    This is an interesting question.

    The phrase "when traceability is a requirement" is present in ISO 9001:2015 regarding calibration in 7.1.5.2, and outputs in 8.5.2, but not specifically raw materials.

    That said, if customers are asking for information about raw materials, it does appear they are interested in your process controls. Maybe they are interested in the material's purity? Did they give you specific requests as to what element they did not want to see in this fabric? (Cadmium, for example)
     
  14. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Outputs are outputs. We must be careful to label things which are not defined in the vocabulary. It’s not limited to the organization’s outputs.
     
    Last edited: May 6, 2023
  15. tony s

    tony s Well-Known Member

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    In clause 8.5.2:

    The 1st paragraph answers the question: “How will you know if the output (e.g. product or result of the process) conforms to requirements?” The requirement for “suitable means” could vary from tags, markings, labels, stickers, color-indicators (pH indicator), sensors, LED warning lights, color coded trays, etc.

    The 2nd paragraph answers the question: “What is the status of the output after inspections or verifications?” Identification of the status could vary from accept/reject, go/no-go, pass/fail, good/better/best, bad/worse/worst, etc.

    The 3rd paragraph is about traceability. ISO 9000 vocabulary defines it as “ability to trace the history, application or location of an object”. Depending on the need for it, traceability answers the questions:
    • What materials did we use? From what batch? What date? Who is the supplier?
    • Who approves the output? Who process it? Who inspect it? Who inspect/accept the materials? Who delivered the product?
    • When was the production date? when did we start the production? When did the materials arrive? When did we deliver the product?
    • Where they are stored? Where they are delivered? Where did we store the materials?