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   QMS auditor Member

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   Is FMEA enough for both 6.1.2.1 Risk analysis and 6.1.2.2 Preventive action?

    

   QMS auditor, Nov 18, 2016

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   MCW8888 Well-Known Member

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   The standard does not mention FMEA in 6.1.2.1 and 6.1.2.2; other risk analysis templates can be used. IMO, FMEA is more for manufacturing.

    

   MCW8888, Nov 18, 2016

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   Andy Nichols Moderator Staff Member

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   Yes, indeed you can! An FMEA can be applied to most (if not all) processes, but be certain not JUST to do the FMEA, otherwise you'll miss something. Have a team map the process then do the FMEA together. DO NOT DO IT ALONE!

    

   Andy Nichols, Nov 18, 2016

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   Lahbib ALAOUA, Csőke Zita and MCW8888 like this.

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