Has anyone done a risk assessment specific for the following section to demonstrate compliance to the revised ISO 13485 standard:
Clause 6 Resource management
6.2 Human Resources
The methodology used to check effectiveness of a training is proportionate to the risk associated with the work for which the training or other action is being provided.
If yes then would FMEA
be the right technique to evaluate the risks associated with ineffective training?
I think there is some misunderstanding here.
The requirement mentioned is related to the "level" of the methodology to check the effectiveness, based on the work (activities) being trained. So this is not related to risks of ineffective training (although it's part of the analysis), but risks related to not doing the work correctly.
You should be doing an analysis of the work not being done correctly as part of requirement 4.1.2b. There, one of the sources (a possible initiating event in the risk analysis) can be that training is innefective.
Then, based on the the results of the analysis of the risks related to that activity, you should define a methodology for verifying the effectiveness of the training.
For example, if the risk related to the work activity not being fulfilled is very high (for example, the death of a patient), you may have to use a very stringent and detailed process for evaluation of effectiveness.
One real example of this would be in the case of unintentional ingress of particles from the manufacturing process into the device, leading to a high risk condition in the patient. In this case, if for example visual manual inspection of particles would be the risk control measure, there would need to be a training on how to perform the inspection. If you decompose the inspection process, you will find something like what is show in the attached file. In the case of this high risk outcome, your would probably need to detailed evaluation of the inspection training with relation to the human factors aspect of the inspection (focused on the cognitive component of the infection process), using human factors techniques such as task analysis to create a formal method of verification of cognitive components (between other components, obviously there would be a need to evaluate other things, too)
Now, let's say that the inspection is for something that, if not done correctly (again, this would come from the process risk analysis related to product risk management), will not harm the patient (for example, it's inspection to verify that the device is clean, but if it's not, there's no harm to patient). In this case, maybe only a general training on inspection, with a quick evaluation of each student, would be ok.
Also, FMEA is a technique focused on failure mode of components of a product, and related outcomes. There are other, better techniques to analyze the risks of problems like the ones mentioned (for example, knowing the harm to the patient due to a non-fulfillment of the work, you can use an FTA do derive the hazardous situation and possible sequence or combination of events).