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Question about identification and planned changes

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by J Jones, Sep 7, 2018.

  1. J Jones

    J Jones New Member

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    Greetings,
    I was hoping to gain some insight into an issue I am having with an internal audit. We are a small manufacturing company.

    Usually each day's production run is assigned a unique lot number that follows it through inspection and packaging. We can trace specific boxes back to the inspector, operator and material heat lot.

    Now unique identifying lots are being abandoned in the warehouse.

    Come to find out, they are assigning generic lot numbers based on inventory locations. So if there are 20 boxes in an inventory location, all of those boxes are assigned the same lot number. This would include multiple days of production, which before would have contained 20 unique lot numbers.

    No lot number is being marked on the boxes. The only marking on the outputs are Part Number and Quantity

    From my understanding, the standard does not specify how deeply outputs need to be traceable, it seems to be left to the organizations discretion.

    Here are my questions:
    1. We have multiple inspectors in QA. Without specific lot numbers, do we not lose traceability to the person authorizing the release of products and services per section 8.6? There is no way to know for sure who inspected and authorized any specific box of parts.

    2. We lose traceability back to specific heat lot numbers for raw material. Especially if multiple bundles were consumed. Is that a requirement of the standard? This would also mean that we might lose the ability to evaluate our material suppliers.

    3. Even if we are using generic lot numbers, shouldn't they still be applied to the boxes to conform to section 8.5.2? Does the part number suffice to identify the status of outputs and that they conform to product requirements? Isn't that what the lot number is for?

    4. This seems to be a knee jerk decision by two members of upper management. I could find no evidence that this was a planned change or that anyone else was aware. I was looking at section 6.1.1 and I don think the risks of this change were considered. Certainly it is not addressed on our Risk Matrix. I think this change increases our risk. The needs and expectations of our customers were not considered. Lastly, I don't feel this change enhances customer satisfaction at all, in fact, I think it achieves the opposite. BUT, I couldn't find anything in the standard that says you cant make changes that increase risk.

    Is anything in here a non conformance? If upper management wants to make this change, there is nothing in the standard that states how detailed our traceability needs to be.
    I am not sure if there is anything here that needs to be addressed or if it is all in compliance.
    I want to be careful not to cloud my audit with my own biases and judgements. Personally I think this is a dumb move that weakens our QMS.

    Any input would be appreciated.
     
  2. hogheavenfarm

    hogheavenfarm Well-Known Member

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    As far as non conformances go, the bulk of that would depend on your documented processes. What do you say you will do? Are you not following that? Traceablity becomes another huge issue, and the risk is large and very real. I remember I saved one company a huge amount of money, maybe even kept them, afloat because I had heat certs on traceable material, otherwise the customer was going to reject everything we ever made en masse. I was able to lock down a tiny percentage that MAY have been affected, and prove it through documentation. We still replaced some, but only a small fraction of what would have been. There are other here who will fill you in on the actual requirements, but the risk involved here is potentially company-destroying. I remind my bosses that our QMS also serves as a liability shield, so it is an essential part of the business. Shortcutting processes can be very expensive.
     
  3. J Jones

    J Jones New Member

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    Thanks for your response. No, we are not following our current documented procedures. This was a decision made by 2 members of upper management and no one else was even aware of it. The quality manager certainly didn't know this was happening.
    I understand what you are saying and I agree with you. IMO this is a terrible decision that weakens our QMS increases our risks.

    Could you please expand on the liability shield you referred to? Do you have any examples how keeping up with the unique lot numbers could shield us?

    Thank you.
     
  4. hogheavenfarm

    hogheavenfarm Well-Known Member

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    Essentially, because I had material traceability to a specific lot and batch, I prevented the entire product line from being recalled for replacement, I was able to show the customer the defect was limited to just one item of a very small quantity. We did have to replace that at our expense, but had we not been able to identity which products were affected, our entire product line would have been quarantined until third party testing could verify it.
     
  5. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I'd add, since it seems to be an issue you identified in your OP; "Is traceability a requirements?"

    By that I mean, do your customers require it? Do you follow any regulations which require it? Does your own organization benefit from lowered risk as a result of being able to trace lots at some level?
     

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