Test Method Validation

Six Sigma – iSixSigma Forums General Forums General Test Method Validation

  • This topic has 2 replies, 2 voices, and was last updated 6 years, 2 months ago by Aws Training in Chennai.
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  • #55051

    James Walsh

    While I am aware that it is good practice from a six Sigma point of view, is it a regulatory (e.g. FDA) requirement that all test methods listed in a process validation be validated? For example, if you are planning on validating a pouch sealing machine and one of the things you plan on testing for, is the seal strength of the pouch. Does your seal strength test method need (from a FDA point of view) to pass a gage R&R?


    Amit Kumar Ojha

    Dear James,

    In general, every measurement system must be validated before you can use the same for measuring the CTQ’s. Here one of the CTQ’s you have mentioned is Seal Strength. In this case if you happen to assign this task of measuring the seal strength to 3 operators, how would you ensure that the variation in the measurement of the seal strength is not due to operators’s measurement techniques but is really the variation in the strength.

    I would recommend MSA to be a done for every measurement and also if MSA has been done once for an instrument in the past, it needs to be performed again in order to ensure that the instrument is reliable enough to produce same measurement over a long period of time.

    All the best.


    Aws Training in Chennai

    Test method of validation of documented process of encusring a test method very suitable its intended uses.It’s involves is establishing the performance character very keep and limitations of a method and it’s identifiacation for influences if may be change for characteristics.

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