Manufacturing site relocation of pre amendment Class II medical device

#1
Good Day -
Trying to determine what a risk analysis would look like for moving our manufacturing process of a pre amendment class II medical device. Thanks in advance for inputs.
 
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#3
That sounds like a good direction. For the FMEA, would i consider elements such as equipment being moved, potential failures resulting from the move, and potential failure modes at start up?
 

yodon

Staff member
Super Moderator
#4
Absolutely! Anything that can go wrong. Don't forget utilities (electrical, process air / vacuum, etc.). These may be different at the new location and have an impact.
 

QAengineer13

Quite Involved in Discussions
#5
Absolutely! Anything that can go wrong. Don't forget utilities (electrical, process air / vacuum, etc.). These may be different at the new location and have an impact.
I agree with Yodon, in addition I would also look into the Control Plan as the output of your new FMEA can trigger changes to your existing Control Plan document.
 
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