I’ve had my post viewed by a few people, but no feedback, is it not something done in the industry? IQOQ is done on every equipment? I’m really interested in your view 
Original post:
Is there good documentation out there that could help with which equipment needs calibration only and not IQ/OQ, example a balance or Microscope you wouldn’t IQOQ but just make sure that it is in your maintenance system.
Thanks in advance for your help!!!
IQ/OQ may not be needed if you have calibration and/or procedural controls around the equipment which cover the key elements of qualification including equipment receipt, equipment calibration, equipment operating/maintenance procedures, etc. We see this mostly with measuring and test equipment. In this case, it is detailed in the governing equipment or qualification procedures that these particular types of equipment will be handled differently. You may then have a separate procedure for what activities are required for certain items.
The philosophy with regard to qualification that has been specified in VMP need to be followed. In VMP, we normally describe the company strategy regarding qualification/validation/calibration/preventive maintenance/operational procedures etc.
ISPE’s “commissioning & qualification” part can be referred as basis. As specified in ISPE, requirement & extent of qualification shall be based on Impact assessment of equipment. Through such impact assessment, equipment criticality can be documented as direct/Indirect or No impact equipment.
In my opinion weighing balance & microscope both may need qualification (based on its application) & only calibration may not suffice the requirement.
[quote=Ravi Dhanbhar]The philosophy with regard to qualification that has been specified in VMP need to be followed. In VMP, we normally describe the company strategy regarding qualification/validation/calibration/preventive maintenance/operational procedures etc.
ISPE’s “commissioning & qualification” part can be referred as basis. As specified in ISPE, requirement & extent of qualification shall be based on Impact assessment of equipment. Through such impact assessment, equipment criticality can be documented as direct/Indirect or No impact equipment.
In my opinion weighing balance & microscope both may need qualification (based on its application) & only calibration may not suffice the requirement.[/quote]
Can you clarify why calibration only won’t suffice? What other tests will be required that a calibration will miss and thus compromise the validity of using such equipment/device/system. 