Process Qualification, Equipment Qualification, Operator Qualification - Sequence?

[rcm_mech]

Hello Friends,

what should be qualified first process, equipment or operator?
what is the proper sequence for it?

i.e (process qualification then equipment qualification and last operator qualification?)

Thanks in Advance

 

[Umang Vidyarthi]

Re: Process Qualification, Equipment Qualification, Operator Qualification - Sequence

Hello Friends,

what should be qualified first process, equipment or operator?
what is the proper sequence for it?

i.e (process qualification then equipment qualification and last operator qualification?)

Thanks in Advance

You already have the right sequence.

Umang

 

[AndyN]

Re: Process Qualification, Equipment Qualification, Operator Qualification - Sequence

Back, some time ago, there was the concept of process dominance to be considered. Often, there are aspects of the process which have more influence on the output. For example, in certain types of welding, the operator is dominant. In machining processes, the set-up can dominant and so on. Considering this might help.

 

[somashekar]

Re: Process Qualification, Equipment Qualification, Operator Qualification - Sequence

Hello Friends,

what should be qualified first process, equipment or operator?
what is the proper sequence for it?

i.e (process qualification then equipment qualification and last operator qualification?)

Thanks in Advance

In terms of what we call IQ / OQ / PQ in that order ...
I (installation) comes close to Equipment
O (Operational) comes close to Process
P (Performance) comes close to Operator
The Q is Qualification

 

[Ajit Basrur]

Re: Process Qualification, Equipment Qualification, Operator Qualification - Sequence

Hello Friends,

what should be qualified first process, equipment or operator?
what is the proper sequence for it?

i.e (process qualification then equipment qualification and last operator qualification?)

Thanks in Advance

You start with a "competent" operator and when the Organization goes for a new equipment, then comes IQ, OQ and PQ which somashekhar has mentioned.

As part of the OQ, you again have to train this "competent" operator and train the relevant people on use of the equipment.

So when you complete your PQ, you have a qualified equipment and trained operators to start the process for Process Qualification.

Hope that helps !

 

[rcm_mech]

Re: Process Qualification, Equipment Qualification, Operator Qualification - Sequence

Hello friends ,

Then what parameters are to be in equipment qualification(Are those process parameters taken/refered from process qualification)?

If this is the case, in process qualification ,we have to identify parameters being variables , get the permeation and combination of those variable parameters , get the best result that will be an input to equipment qualification???????

Thanks in Advance

 

[somashekar]

Re: Process Qualification, Equipment Qualification, Operator Qualification - Sequence

Hello friends ,

Then what parameters are to be in equipment qualification(Are those process parameters taken/refered from process qualification)?

If this is the case, in process qualification ,we have to identify parameters being variables , get the permeation and combination of those variable parameters , get the best result that will be an input to equipment qualification???????

Thanks in Advance

After your evaluation and selection of the equipment, the consideration here is for installing and commissioning of the equipment and its other proper services .. like Power (the right kind with voltage control / regulation etc.) Stability (Alignment, anti vibration foot, rigid and stable mounting, need for an air conditioning if needed, etc etc ..) proper and right level of service inputs (oil, air, filters, etc etc..) The calibration of any monitoring and feedback instruments as necessary to the equipment that will ensure the optimum performance.
When these are provided and checked to be in line with the equipment recommendation, the next step of equipment use and parameters setting for desired performance is taken up.

 

[Ajit Basrur]

Re: Process Qualification, Equipment Qualification, Operator Qualification - Sequence

Equipment Qualification is done to ensure that the equipment that is used in the process is satisfactory.

Process Qualification is done to ensure that your process is stable and to ensure consistency of the process over time.

 

[Jim Wynne]

Re: Process Qualification, Equipment Qualification, Operator Qualification - Sequence

Hello Friends,

what should be qualified first process, equipment or operator?
what is the proper sequence for it?

i.e (process qualification then equipment qualification and last operator qualification?)

Thanks in Advance

Why do those things have to happen serially rather than concurrently?

 

[jkuil]

Re: Process Qualification, Equipment Qualification, Operator Qualification - Sequence

It all depends on the change.

If it is a new proces for which new equipment is purchased, you need to qualify the installation of the equipment and perform the operational qualification (does the equipment operate properly). Before you commence with the PQ (does the equipment also perform consistently within the intended use environment) you need to train the operators to use the equipment (operator qualification. As part if the PQ the variability due to operators can be assessed (which is not called operator qualification). You don't want this assessment being influenced by unqualified operators.

If you have a new proces using equipment for which IQ/OQ data are adequate for the new purpose, you only need to perform the PQ.
If you have new equipment replacing old equipment it might not be necessary to perform the PQ (if IQ/OQ demonstrate the equivalence with the old equipment)