Self-training or Self-studying

[Azhar Anwar]

Is self-training or self-studying (by reading procedures, white papers or watching a webinars ....or whatever)) acceptable as training (as part of CAPA for example) in quality management system (ISO 13485 or 9001 etc..)? If yes, what is the best way to document it ?
I work for a small medical device company. Due to the fact that there is limited of resources available, we need to depend heavily on self-trainings.


Thanks in advance !

 

[William55401]

Welcome to the Cove. This is one acceptable way of training delivery. Read and acknowledge. Some procedures / domains are better served by instructor lead with tests for effectiveness. Your QMS should allow for both individual and instructor-lead classroom study. It is not an either or. Hope this helps.

 

[Jim Wynne]

First, training is usually not a good corrective action response. Why were untrained people doing the job? This brings us to the idea of competence. How do you assure that people are competent. Training of almost any sort is good, but training ≠ competence.

 

[Azhar Anwar]

First, training is usually not a good corrective action response. Why were untrained people doing the job? This brings us to the idea of competence. How do you assure that people are competent. Training of almost any sort is good, but training ≠ competence.

Thanks Jim, I agree with you on this. But training as corrective action response was just an example here. There are also other cases such as updated/ new processes or regulations/standards, where we need to train as well.

 

[RoxaneB]

Training - be it self-directed or otherwise - can be PART of a correction action plan, but it likely is not the only activity that needs to be done. And, at the end of it, there needs to be a metric that the training (as well as the other activities on the action plan) can influence, hopefully in a positive way.

 

[Jim Wynne]

Thanks Jim, I agree with you on this. But training as corrective action response was just an example here. There are also other cases such as updated/ new processes or regulations/standards, where we need to train as well.

You can record the training--in whatever form it takes--however you wish to do it. You're still left with verifying the effectiveness of the training.

 

[Tidge]

If you are at a small company, I suggest some sort of instructor-lead activity done AFTER the attendees attest that they have read the *whatevers*. You can have them sign in to that activity and then you will have *slightly* more than just an attestation that they are self-trained via reading.

Personally: I don't believe that self-directed learning via reading is particularly effective, and I won't make any pre-judgements about how effective a zoom meeting would be... but at least such a plan is covering two different types of learners (in addition to getting some evidence of training)

 

[Azhar Anwar]

Many thanks to you all. It was very helpful.

 

[yodon]

A little late to the party but keep in mind that if you do training you need to assess the effectiveness of training (in a manner proportionate to the risk associated with the work for which the training is provided). As this is a response to a finding, you may want to 'elevate' that effectiveness assessment.