Vision system process validation

#1
I have a vision system which makes attribute (pass/fail) decisions about barcodes on labels for medical devices.
The vision system is actually integrated with an automated assembly line.
The automated line is about to undergo IQ and as a part of this IQ the vision system will be challenged in a functional aspect of the IQ (but the vision system can only be functionally challenged after the core IQ components of the protocol are executed successfully - to ensure its actually IQ'ed correctly).
For the vision system functional testing FMEA risk based sampling plans has been incorporated to test statistically valid plans for pass and fail (created fails).
So, I plan to complete this IQ and then drive straight to PQ. No OQ as no low or high variable values can be changed by operator. No other settings on the rest of the automated line can be altered either.
For PQ, this will be a full automated line PQ which includes the vision system inherently. PQ is commercial product and will not have created fails introduced to demonstrate vision system fail detection capability.
So, long story short, is this process validation approach acceptable from a fda audit trail?
I am concerned the vision system has not undergone msa (even though the functional testing properly demonstrates pass or fail determination)
Thanks
 
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#2
The automated line is about to undergo IQ and as a part of this IQ the vision system will be challenged in a functional aspect of the IQ (but the vision system can only be functionally challenged after the core IQ components of the protocol are executed successfully - to ensure its actually IQ'ed correctly).
IQ is usually limited to installation according to the equipment manufacturer specifications. I would bucket any kind of challenge activity under an OQ.
Have you read GHTF SG3? https://www.imdrf.org/sites/default...g3-n99-10-2004-qms-process-guidance-04010.pdf
 
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