Verifying training effectiveness for procedure changes

[lisasolo]

Hi all,

My company implemented all required changes for ISO 13485:2016, including verification of training effectiveness based on risk. Our procedure includes quizzes or demonstration of knowledge for high risk, discussions for medium risk and monitoring for low risk.

This has been working for us, but we have come upon an issue when documents are changed. When documents are changed, we always retrain employees that were trained on that document. We do not have a method of verifying the effectiveness of this retraining. It does not make sense to have employees retake a quiz each time a high risk procedure is minorly changed. Does anyone have any ideas for this situation? Thank you!

 

[normzone]

In my previous life our training document had a signoff block at the bottom, where the trainer signed one of three blocks attesting that they verified the effectiveness of the training through one of these:

Question and answer
Test
Observation

 

[dst89]

My company is ISO certified. Whenever changes are made to SOPs, the quiz is also updated/revised to incorporate the changes. Everyone who was trained originally has to retake the new quiz for effectiveness training.

 

[yodon]

To me, quizzes and Q/A sessions are often used to satisfy the ISO requirement (and admittedly, I use them, too) but are they truly a measure of effectiveness? Are you seeing deviations or NCs after the procedures are changed? We also monitor this aspect and discuss in Management Review.

 

[insect warfare]

Hi all,

My company implemented all required changes for ISO 13485:2016, including verification of training effectiveness based on risk. Our procedure includes quizzes or demonstration of knowledge for high risk, discussions for medium risk and monitoring for low risk.

This has been working for us, but we have come upon an issue when documents are changed. When documents are changed, we always retrain employees that were trained on that document. We do not have a method of verifying the effectiveness of this retraining. It does not make sense to have employees retake a quiz each time a high risk procedure is minorly changed. Does anyone have any ideas for this situation? Thank you!

First things first - welcome to the Cove!

You stated that you do not have a method of verifying effectiveness of this re-training, which essentially means that you first need to define (and possibly document) such method(s).

For example (and this is just a suggestion), you could document in your training process that the following activities are acceptable as evaluation methods: 1) interactive Q&A, 2) completing quizzes, tests or other types of assessments, and/or 3) applied demonstrations by the worker of knowledge gained through training or instruction. This may provide the flexibility you need to escape the "retaking a quiz each time a high risk procedure is minorly changed" trap.

If you use a form to capture evidence of training, you could insert separate signature fields into the form, such as "Trained by" and "Evaluated by" to show evidence of training and evaluation together, even though they may or may not be done by the same person (it would not matter how the evaluation was done as long as it was done according to the documented training process, although you may want to track this specifically). The signatures, of course, then serve as an acknowledgment of the activities performed.

Please keep in mind that competency is the ultimate goal, but it is also prudent for your organization to have appropriate records of training and evaluation, notwithstanding any management system certifications.

Brian