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  • 1.  Validation of a measurement system

    Posted 09-May-2018 15:10
    I need to validate an optical inspection machine/system that is used to measure features of screws.  These are screws that are used in conjunction with a class 2 medical device.
    System is made by Oasis Inspection Systems.  It is basically a shadowgraph with easy semi automaed edge detection and measurement capability.

    I have heard that some medical device makers in U.S. use MSA (measurement system analysis) based on an ASTM E2782 std.
    Others, specially makers who sell internationally, do a full on validation.

    I would appreciate it if someone can provide info on which ISO stds I should use to validate this machine.

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    Robert Nami
    Carlsbad CA
    United States
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  • 2.  RE: Validation of a measurement system

    Posted 10-May-2018 03:58
    I've used the AIAG MSA book before for guidance on conducting measurement analysis.   The important point is to make sure you are validating the test method for its intended use.
    basic requirements would be:
    qualification of equipment
    calibration that covers full range required
    SOPs and training
    Capability (GR&R/ATMV etc)

    good luck with your project
    seb

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    Sebastian Clerkin
    Consultant
    Cork
    Ireland
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    Original Message


  • 3.  RE: Validation of a measurement system

    Posted 10-May-2018 10:47
    thank you very much for the helpful response.

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    Robert Nami
    Carlsbad CA
    United States
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    Original Message


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