I am working on creating a template for process performance qualifications that will be used throughout several corporate companies. The question has come up of how to deal with training.

My thoughts: Process PQ should be following standard working procedures to show that the process is repeatable in normal operating conditions. Thus, if we show that the operators working on the runs have been trained to standard procedures and any work instructions associated with that process, that should be sufficient.

Other thoughts: Anyone doing any work related to the Process PQ protocol should be trained to the protocol itself. This would include any operators working on the runs, inspectors taking measurements, office staff compiling paperwork, etc.

Anyone have any other thoughts on this subject?

Although the operators may be trained in a particular procedure (process), there will be varying levels of competance.

This variation in competance (or understanding) can lead to process variation, which can effect the validation results.

I find it best to be present when performing the PQ runs, in order to gauge the accuracy of the process under normal conditions.

It always works well when I actually take the time to explain what we are trying to achieve (face to face), and usually get alot of good buy in from my involvement.

That makes sense, but don't we want to have those varying levels of expertise involved to show "normal" conditions?? Maybe I am confused on the goal here...

Well it depends..... if the varying skill level is present in the process from individuals, then you should try and capture that in the PQ.

The PQ will be representative of the worst case (with individuals capabilities varying), otherwise you may get a good result with the "better" trained operators, only to find that in normal production the results "could" be different.

I would err on trying to ensure the process is robust with the "adverse" conditions.

So in showing that the process works under "adverse" conditions, should the operators be trained to the protocol itself or should they perform the work with their normal training? It seems to me that if we train the operators to the protocol it puts more stress on the importance of these runs, making the operator work differently than normal which would give non-normal results. So does this truely show that the process is repeatable under normal operating conditions?

Personally , I wouldn't train them in the protocol - just explain that we need to run a batch (or part batch) and say that we are measuring the performance / variables.

Generally, I've found that most people want to do a good job and understand what they are doing, and how it effects the next customer.

Of course, you make a good point, that in raising the awareness of the protocol you do effect the output and possible performance of the individuals.
In process checks / monitoring should be an output of the validation activity to ensure that the output stays where the original PQ work defined. If it doesn't then something must have changed (within certain tolerances).