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Removing Non Value Added Inspection

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by pcmc47, Jan 29, 2016.

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  1. pcmc47

    pcmc47 New Member

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    So we have a custom quantitative, destructive quality test for our Class II device that was originally put in place as a part of design validation but is also used for final inspection of the devices. There is not any type of industry standard or guidelines around this testing. The way that the device is designed, there is really no way for the device to fail this test. The Cpk is approaching 2.0, the 99% lower confidence limit is almost double the failure point, and I have a year’s worth of data and ~20 consecutive lots with nothing near a failure.

    We would like to remove this testing as lot release but keep it as a part of design validation. I am thinking we could put together a strong, statistically based rationale for why this testing is no longer necessary for lot release. Is there anything I am missing? Are there any other considerations anyone can think of prior to moving forward with this approach?

    Thanks in advance for any thoughts or advice!
     
    pcmc47, Jan 29, 2016
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  2. Miner

    Miner Moderator Staff Member

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    I'll state up front that I have no background in medical devices. Having said that, I do have a lot of experience with removing non-value added inspection whether done manually or automated.

    The first place that I start is with design validation tests that somehow got into manufacturing inspection. These are fine as a design validation test, but not in manufacturing. Inspections should focus on issues identified as higher risk in a Process FMEA. They should focus on defects caused by assembly, processing or suppliers. Next I look at inspection records. If I see an inspection that has had zero defects for 5 years and it is low risk, it's gone.
     
    Last edited: Jan 29, 2016
    Miner, Jan 29, 2016
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  3. Bev D

    Bev D Moderator Staff Member

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    is teh test part of your offiical release test plan with the FDA? if so you probably ahve to submit your data to get approval to remove the test.

    You have a strong statistical case that demonstrates capability and stability. The only thing I would add is the scientific rationale for why the device can't fail...or what the manufacturing controls are that prevent failure...
     
    Bev D, Jan 29, 2016
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