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Not conducting Gage RR

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  • #50543

    Sorour
    Participant

    Hello,
    Is it possible to conduct a risk assessment on a test method (paper exercise) and conclude that calibration and operator training are sufficient and a gage R&R does not have to be completed.
    I would have assumed a physical assessment of the gage would be required to be able to make a statement about the gage capabilities.
    I work in the medical device industry.
     Thank You
     

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    #173843

    Taylor
    Participant

    Paul
    Sure, you can perform a risk assessment on paper, and you may be able to convince people that it’s sufficient, but I wouldn’t bet my companies product going out the door that it will meet my customers requirements. Especially, in the Medical industry
     
    just my opinion

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    #173845

    Ron
    Member

    To add to the previous response: A gage R&R as weell as a linearity study needs to be perfomred to assure that all elements of the measurement process are repeatable and reproducible overt he full range ofthe gage. It also assures that different operators and thosethat inteerface with the gage are competent.
    Why are you hesitating ??? Is there something you are not stating?

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    #173849

    Sorour
    Participant

    Hi,
    Thanks for the responces. I am new to the company and to be honest i am in fovour of doing the gage R&R studies but risk assestments have been completed previously and i am meeting resistance.
    wouldyou guys recommend choosing the smallest component (hardest to hold and measure) as the component to do gage r&g on snap gauge. this would capture most difficult interaction.
    thanks
    paul

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    #173862

    Taylor
    Participant

    To be quite honest Paul, you should perform an R&R on all the parts which the gage is used for. If you want to start with what you perceive as the most difficult, that is fine; however be aware, human interaction with gages can be opposite of what you might expect, especially with snap gages. Just my experience
     

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