may anyone help me?
I would like to know when it is necessary that operator/analyst (ecc.) need have a new training. For example, in my Plant we use to train everytime SOPs are reviewed. For example everytime analytical SOPs are reviewed, analysts of laboratory have a new training.
I know that others Company don’t follow this approach explaining that in laboratory they provide analytical SOPs for analyst who have the possibility to look and follow.
I would like to know your opinion, what is correct approach in compliance with GMP?
We have this approach in Quality Environment
I = Identify the people who are slow at their work places
E= Evaluate as per their dociments and work procedures what they require
P= Plan in advance the training materials, Schedules and after training tests
T= Train all required people and make them understand and make them do their tests
E= Evaluate the each and every person after training weekly once for 2 months
S= Evaluate the short commings and gaps
T= Train them and re-evaluate them
Training and evaluation is a continuous process. One who identifies short commings of people in various departments and plan for is a smarter person.
The whole issue is the identification process. (Q.R.I)
I’m sorry Durga, perhaps I don’t well explained my question
so I try to repeat the question
if an analyst have to read a procedure that he is executing it, it is necessary to train the analyst on the same procedure?
If this procedure is reviewed it is necessary training?
many thanks in advance
Take time with him and evalute how he is doing that particular procedure. Evalute atleast 4 test results he performed. If you find any descrapancies in that you ask why they were there?
Any calculation errors?
So you can figure and pin point out his need.
His need is company’s need.
After review you must decide if training is required or not.
If at all training is required what level must be understood too.
Thank you very much
but you think that is it a must that when a SOP is reviewed (for example from revision 1 to revision 2) it has to train again the same analyst who use that procedure?
My question is if is it must for GMP?
The whole GMP is based on Pharmaceutical Quality system.
It continous improvement.
Yes it should be mentioned in training SOP’s about reviews in form of a Flow chart and little explanation and evaluation sheet model.
The evaluation sheet must be with Human Rescourse department.
It is continuous evaluation too.
You need to evaluate when a Training is ineffective enthough the person is 100% trained.
Some points to consider are
[COLOR="#000000"]•Is the flaw related to the employee?
•Is the flaw related to the qualified trainer?
•Is the flaw related to inadequate training procedures?
•Is the flaw related to inconsistent delivery of the training materials?
•Is the flaw related to the task at hand (procedure being performed)?
•Is the flaw related to the training setting or scheduling conflicts?
•Did the requirements of other organizational systems change or create a performance conflict?[/color]