Documenting Self-Training and Effectiveness - ISO 13485:2016

#1
I'm a part of an organization that is moving to ISO 13485:2016. We currently do NOT have an lms which is troublesome. How do we track self-training using paper training forms, then be able to justify training was effective? I have years of experience with lms', but in this company we are relying on spreadsheets and paper.

Any insight would be gratefully appreciated.
 
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yodon

Staff member
Super Moderator
#2
Bear in mind that little note at the end of section 6.2:

The methodology used to check effectiveness is proportionate to the risk associated with the work for which the training or other action is being provided.


If (ineffectiveness of) the training could lead to risk, you probably want to assess one way; e.g., some kind of immediate assessment; whereas if it would not lead to risk, you could take a more relaxed approach; e.g., annual employee performance review (did your work comply with the training - if so, check, effective).
 

RoxaneB

Super Moderator
Super Moderator
#3
I'm a part of an organization that is moving to ISO 13485:2016. We currently do NOT have an lms which is troublesome. How do we track self-training using paper training forms, then be able to justify training was effective? I have years of experience with lms', but in this company we are relying on spreadsheets and paper.

Any insight would be gratefully appreciated.
I'm presuming the training form you mention is simply something that has the person's name and position, along with the training material/subject and date. If this presumption of mine is true, then what you have is simply a (self) declaration of qualification; it has very little to do with the effectiveness of the training.

Most processes have metrics or ways of measuring their results.

Let's say you were training people on an improvement to the process of making widgets - say a new piece of equipment that is faster and more accurate. By measuring and monitoring items such as utilization, defective product, machine uptime, etc., you can assess training effectiveness. If, for example, the % of defective products remained unchanged (or worsened), perhaps the people were not effectively trained on how to properly use the new machine.

This type of assessment on the effectiveness of training could take some time.

If you're looking for a more immediate evaluation of training effectiveness, you could implement tests at the end of training on priority processes. I'm not a huge fan of this approach as I find it's more about evaluating short-term memory than actual application of the training.
 
#4
So I believe there is quite a bit of risk from the perspective of the training team not receiving training records back from employees who self-train (we wouldn't know training happened) and that we have a gap in checking for effectiveness being paper based. An lms would be ideal to train, track, assess, etc. This is a part of my gap analysis.
 

yodon

Staff member
Super Moderator
#5
Whoops... I think I may have misled you. The risk is not the risk of failing to have records. The risk in the note is talking about the risk to the patient / user if the training is ineffective. So if the training is on something that could, if not done correctly, cause harm to a patient, your method of checking effectiveness needs to be elevated above that for training on things that wouldn't harm a patient / user if not done correctly.

For example, if you're training a person to do final testing on a device that delivers x-rays and the test is ensuring the emitter output is in the specified range, your effectiveness check on that will be different (more urgent, higher level of assessment) than that of training, say, to detect cosmetic defects in a device's plastic casing.
 
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