How to qualify (IQ, OQ, PQ) a multi-purpose equipment ?

Nash27

Quite Involved in Discussions
#1
I'm setting up an Equipment Qualification program at a composites company and need some help in the best way to approach the ideas of IQ/OQ/PQ as related to new and existing equipment.

Should the IQ/OQ/PQ be done on a "per process/product" basis or a "per equipment" basis? For example, we have an 800-ton hydraulic press that is used in virtually all our products. The IQ would be done once on a per machine basis because the IQ relates to proper installation, adequate inputs (power, cooling water, etc.), and things like that, right?

The OQ and PQ are more difficult for me. Since our products run at different temperatures and pressures, do I pick the highest high and lowest low and run the press through a cycle with each of those parameters? Or, do I have to run an OQ for every type of product we make? Same questions apply to the PQ.

Thanks for putting the informative question
 
Top