Documented Evidence of Training ISO 13485: 2016

[Sidney Vianna]

Thank God this auditor is not a Auditsaurus rex. But in fact it is a customer audit, who is not qualified as an auditor.

Thanks for the clarification. Some people, when assigned to an audit team, without the proper qualifications, end up reporting silly things because they are worried that, if they don’t report something, their competence would be questioned.

 

[QualAl]

Good day @indubioush ;
I don't believe the OP was implying they should not (do not) train nor that they should not (do not) keep records. In fact, the OP states that they DO these things.
The gist of the question(s)... (I infer from "during an audit" that at CB raised the issue), is summed up by...
- " Does this person have to sign off anywhere to show that he has read and understood the applicable procedures or work instruction..."
- "...is there a requirement in the standard (ISO 13485:2016) or Medical Health regulation requirement ..."

There simply is no such requirement.

Be well.

Hi John,

I couldn't have said it any better.

Thanks,

 

[Ed Panek]

Thanks for the clarification. Some people, when assigned to an audit team, without the proper qualifications, end up reporting silly things because they are worried that, if they don’t report something, their competence would be questioned.

This is why if the company requests an observer be present for training I try to refuse that. The auditor may think a minor NC is no big deal and an example for the observer to train on but for me its just more work and a confusing conversation with my CEO. I remember in our 2020 remote audit I agreed to an observer. Within the first 10 minutes of the audit the auditor found something in a document that was at most an OFI imo. I felt he was coaching the trainee on how to write up a minor NC though. The remainder of the week long audit found nothing. I no longer want trainees on the audit.

 

[QualAl]

View attachment 28828

ST Self taught
IL Instructor Led
CBT Computer Based Training
OT Offsite Training

Hi Ed,

Are Self taught instructions acceptable to CB auditors? Do they require some kind of validation and/or proof that they have read that particular document? How would you measure the effectiveness of Self taught instructions?

Thanks,

 

[Quality_Goblin]

View attachment 28828

ST Self taught
IL Instructor Led
CBT Computer Based Training
OT Offsite Training

I really like this matrix of delineating between self taught and instructor led training. For self taught training, how do you determine that the training was effective after the training was completed?

 

[Jim Wynne]

I really like this matrix of delineating between self taught and instructor led training. For self taught training, how do you determine that the training was effective after the training was completed?

You verify competence.

 

[Quality_Goblin]

You verify competence.

I understand that. I am very new to this and am looking for more concrete examples on how one would verify competence.

 

[malasuerte]

I understand that. I am very new to this and am looking for more concrete examples on how one would verify competence.

Simple -

Employee is "certified"/"trained" (whatever it is called) to perform Task A >> Records show employee has performed Task A perfectly 100 times.

Or Employee was required to perform Task A 3 times with peer trainer before being deemed competent.

 

[yodon]

I really like this matrix of delineating between self taught and instructor led training. For self taught training, how do you determine that the training was effective after the training was completed?

Bear in mind that the standard doesn't require you to determine training effectiveness *immediately* after training; just that effectiveness of the actions taken (which can include training) is evaluated.

You should, as with pretty much everything, take a risk-based approach to assessing effectiveness. For low-risk things, we defer assessing effectiveness to the management review (asking "were there any issues that arose because training wasn't effective?"). For high-risk things (i.e., harm could be a result if training is ineffective), @malasuerte suggested one way (although 100 times may be excessive). You can also use an approach like "train the trainer." Other measures (for lower risk) can include quizzes or even discussion. You have the ability here to be creative so don't get hung up on a single approach. Lay out your risk-based approach and apply it.

 

[Zero_yield]

For low-risk things, we defer assessing effectiveness to the management review (asking "were there any issues that arose because training wasn't effective?"). For high-risk things (i.e., harm could be a result if training is ineffective), @malasuerte suggested one way (although 100 times may be excessive). You can also use an approach like "train the trainer." Other measures (for lower risk) can include quizzes or even discussion. You have the ability here to be creative so don't get hung up on a single approach. Lay out your risk-based approach and apply it.

Agreed, and we do all of these approaches for different types of training.

I will say that depending on the operation, 100 times may not be enough. For some of our manual, high-risk processes, we require a few thousand parts before certifying a technician. These are for operations where the technician will be processing thousands of parts a shift once they're proficient. So the certification requires 5000 parts, that might be half a shift's worth or less to an expert technician, even if it usually takes a trainee much longer than half a shift while they're still learning and getting up to speed.