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

J

JettyCatArmy

#1
#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.
 
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Ajit Basrur

Ajit Basrur

Leader
Admin
#2
#2
Welcome to the Cove, JettyCatArmy :bigwave:

I have moved your question to this section where we discuss Qualification and Validation and am sure you will get more responses.
 
somashekar

somashekar

Leader
Admin
#3
#3
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.
Click to expand...
It is not difficult when you understand that you are doing a process validation and not machine capability. The process must target to the product requirement, and the product requirement must be met. So you pick the temperatures and pressures that give you optimum product performance when you perform the OQ. You check and assure the effectiveness of the OQ when you perform the PQ.
 
G

GTJunghoon

#4
#4
I ran in to a similar situation and took the "per process/product" approach. I am fairly new to qualification/validations.

Manufacturing uses a filling machine to dispense products in to containers. The machine is used for a wide range of products that require different settings and considerations. I ended up grouping similar products, and completing IQ/OQ/PQ to qualify the filler for use with each group. The rest of the line include labeling and capping machines, and were qualified for groups of products based on the sizes of containers being filled.

Eventually I'll have the filling, capping, and labeling processes validated for each product. It is taking me forever :(
 
J

JettyCatArmy

#5
#5
GTJunghoon said:
I ended up grouping similar products, and completing IQ/OQ/PQ to qualify the filler for use with each group.
Click to expand...
So, did you do an IQ for each product group? To me that doesn't make sense, since the equipment was only installed once. Did you split the IQ portion away from the OQ/PQ?
 
G

GTJunghoon

#6
#6
If your equipment does not change with products then you do not need to conduct multiple IQs. In my case, 95% of the products used the same equipment with the same set-up. The validation for each of those processes/products referred to the same documented IQ. The remaining 5% required different additions to the filling machine to deal with various components of the product that created unique problems during filling. That 5% had an IQ that addressed the various equipment added to the filler.
 
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