How to create IQ, OQ, PQ protocol for existing equipment

duff999

Involved In Discussions
#1
We have existing equipment that has not gone through any IQ,OQ, PQ, these are existing devices (gages, micrometers) scales, microscopes etc. How would I start to put together a validation list for these. Do hand tools need IQ, OQ, PQ

Thanks
 
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William55401

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#2
It starts with establishing procedures for what you are trying to do. It also sounds like you are focussed on measurement equipment. Yes, it needs to be calibrated. However, most orgs are also performing Test Method Validation on the measurement process. It could be as simple as a Gauge R & R study using a caliper or mic. Once you have your procedures in place for calibration and TMV, you need to develop a list of measurement equipment and understand how & where it is used, then you can proceed with TMV. I was part of a remediation project where we developed a comprehensive process FMEA, including incoming materials, and that was used to identify where we needed TMV as well how we identified the need for manufacturing process validations. If your process FMEA is thorough, you can list the hand tools also and assess their impact. Most orgs end up with simple controls on hand tools that do not perform a measurement function and are not part of a process that needs validation. Hope this helps.
 

indubioush

Quite Involved in Discussions
#3
Start by reading the process validation guidance by GHTF: http://www.imdrf.org/docs/ghtf/fina...g3-n99-10-2004-qms-process-guidance-04010.pdf

If equipment is not installed anywhere, it does not need an IQ unless the IQ is used for recording calibration information and other stuff.
If equipment does not have any settings, it usually will not need an OQ.

You need to consider that equipment validation is tied to process validation. The best thing to do is create a process validation matrix in which you list all your manufacturing processes and determine which ones require validation. Then you need to list associated equipment and determine process parameters.

If the equipment is not used for production but is instead used for receiving inspection, this is where the gage R&R comes in to ensure the equipment is able to measure consistently.

I agree with everything William said above, including the stuff about having a PFMEA. Risk is everything these days.
 
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