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Doing Less Change Orders by Allowing Part Interchangeability

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by John Thacher, Dec 16, 2020.

  1. John Thacher

    John Thacher New Member

    Dec 16, 2020
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    I work for a mid size medical device manufacturer specializing in general assembly and medical kit manufacture. We have a large number of products we are currently marketing. Often we will have a component that is used across multiple products. Ex: Face Mask, luer lock cap, or other similar commodities. The way our system is set up is each item code corresponds to one specification sheet and one supplier item code. Per our current process if a item needs to be substituted for an alternative component from another supplier a new internal item code has to be created, even if the fit form and function of the two components is exactly the same. This becomes a headache for the engineering/quality team as all BOMs need to be updated via change order to include the new component.

    What I would like to do is include alternative suppliers on the specification sheets and in our ERP system that allow purchasing to buy alternative parts under the same item code. Our system is capable of maintaining full traceability of lots from different suppliers to the DHR no problem. Where I am getting push back is that some people are concerned that two lots from two different suppliers could be used on the same production work order. If a complaint were received relating to that item then we would be unable to determine which suppliers part caused the failure.

    I'm wondering if anyone has any experience with this kind of problem or perhaps any guidance on the best way's to implement and control primary, secondary, tertiary, etc.. suppliers?
  2. yodon

    yodon Well-Known Member

    Aug 3, 2015
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    That's a tough one and the concern expressed is valid. If those parts could fail such that a recall would be indicated then you'd have to recall more than necessary.

    Have you looked at it from a risk perspective? If failure of the part is unlikely or unlikely to cause an issue, then maybe you can mix.

    The one place I saw that allowed this was able to split the lot up to enable full identification / traceability. Of course, that only works if you have 1 part from multiple lots. For commodity items like (non-critical) LEDs and screws and such, they deemed the risk was acceptable and allowed mixed lots.