Training Effectiveness

Hello all,
What would be the acceptable methods to satisfy the ISO 13485 requirement (6.2 c) to evaluate the training effectiveness?

It's up to you to decide and should be risk based. Things I've seen:

• low risk - assess annually (e.g. in management review)
• medium risk - quizzes, interaction, demonstration
• high risk - "train the trainer," oversight for a predetermined period

Muna.Salama said:

Hello all,
What would be the acceptable methods to satisfy the ISO 13485 requirement (6.2 c) to evaluate the training effectiveness?

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I am a strong proponent of solutions that are (for the most part) part of existing business processes and I would think the best way to assess training effectiveness, as well as competence management is via the continual performance review process.

I find it funny (and alarming) that many corrective actions conclude that the operator wasn’t competent and the corrective action is to retrain yet they can’t figure out to assess training effectiveness. The question is always about what will satisfy the standard’s requirement and not what will actually assess training effectiveness.

Sad but true. However, the real problem often is that the operator was never trained in the first place, or the process prevents a skilled operator from consistently making good product (i.e., red bead experiment).

Bev D said:

I find it funny (and alarming) that many corrective actions conclude that the operator wasn’t competent and the corrective action is to retrain.....

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Sometimes the issue is that the person assigned to the job was not trained, and there was no way for the supervisor to tell if the employee was qualified without getting HR on the case.

Some of our customers flow down a requirement to maintain a skills matrix. I think that is a good idea.

With said matrix, the process should/could be to check the skills matrix, and provide training when required, and then having the person perform the task (solo or with the trainer guiding them) prior to entering the name on the matrix as qualified.

I really like skills matrices. They are so easy to use and show in a visual way what your skilled staffing level is - no looking through file folders.

Bu they aren't proof of training effectiveness. IF some type of demonstration or 'watch period' is used prior to getting on the list then it can serve as a record of an effectiveness check.

Bev D said:

I really like skills matrices. They are so easy to use and show in a visual way what your skilled staffing level is - no looking through file folders.

Bu they aren't proof of training effectiveness. IF some type of demonstration or 'watch period' is used prior to getting on the list then it can serve as a record of an effectiveness check.

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We have that on our training matrix, for certain jobs there is a quota of samples to be completed and inspected by senior staff one they are completed to a 100% pass rate they are signed off on the matrix.

mattador78 said:

We have that on our training matrix, for certain jobs there is a quota of samples to be completed and inspected by senior staff one they are completed to a 100% pass rate they are signed off on the matrix.

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We adopted a similar approach. Only qualified people can take role responsibility in medical device projects, and to be qualified, they need to show hands-on experience, which can be gained by participating in authoring/reviewing documents or performing activitoes under supervision of experienced employees.