All,
I know this clause has been discussed, however, I think I'm getting a little wrapped around the axle with how to implement the requirements.
The company for which I work is a team of 8 with 3 people manufacturing and the remainder doing operations (excluding me with QA/RA), therefore, I want to keep this procedure manageable and simple.
However, I'm stuck with level of risk associated with work not being done properly and demonstrating competency regarding the different levels of risk. Does the risk level have to be defined for each training task (this would be cumbersome)? Or, can the procedure be more generalized with an overview of high or low risk? For example, training for technical procedures is high risk and (e.g. laboratory processes, shipping of product, etc.) shall consist of trainee observation of processes and demonstration of processes under the supervision of a qualified trainer. Once the trainer finds the trainee competent, the trainee is signed off for that process.
For low risk, non-technical procedures, the training platform may be a read/understand, discussion, presentation.
Any assistance would be most helpful.
Tonia
I know this clause has been discussed, however, I think I'm getting a little wrapped around the axle with how to implement the requirements.
The company for which I work is a team of 8 with 3 people manufacturing and the remainder doing operations (excluding me with QA/RA), therefore, I want to keep this procedure manageable and simple.
However, I'm stuck with level of risk associated with work not being done properly and demonstrating competency regarding the different levels of risk. Does the risk level have to be defined for each training task (this would be cumbersome)? Or, can the procedure be more generalized with an overview of high or low risk? For example, training for technical procedures is high risk and (e.g. laboratory processes, shipping of product, etc.) shall consist of trainee observation of processes and demonstration of processes under the supervision of a qualified trainer. Once the trainer finds the trainee competent, the trainee is signed off for that process.
For low risk, non-technical procedures, the training platform may be a read/understand, discussion, presentation.
Any assistance would be most helpful.
Tonia