Training record - how to verify valid training participation

[Aphel]

Hello.
My specific question regarding training records:

How to ensure integrity of training records - regarding what is required to demonstrate a person has participated?

Example:
An internal quality system procedure training takes place.
The trainer writes down the names of persons who participated during the training.
Afterwards the trainer archives the participation list.

Would it be required, that this participation list is signed by someone, indicating the content of the record is correct and valid?
Opinions?

Thanks in advance.
Aphel

 

[ScottK]

Hello.
My specific question regarding training records:

How to ensure integrity of training records - regarding what is required to demonstrate a person has participated?

Example:
An internal quality system procedure training takes place.
The trainer writes down the names of persons who participated during the training.
Afterwards the trainer archives the participation list.

Would it be required, that this participation list is signed by someone, indicating the content of the record is correct and valid?
Opinions?

Thanks in advance.
Aphel

In the device and drug world I have found that the expectation is some sort of positive acknowledgement by the trainee as part of the training record. Depending on how the training was conducted, this could be an email to the trainer saying "I received and understand the training", a physically signed training form, a certificate, etc... as long as there is a record.
You may also have different "levels" of training - like a procedure revisions may simply require a "read and understand" email back to the trainer; where some in-depth, hands on training may have a signed training form.
It's usually not good enough for regulatory bodies to have a list of attendees from the trainer- they tend to want acknowledgement of the training from the trainee.

 

[Nichole F]

Generally, I've seen companies also have the people being trained signed showing they attended the training. Usually there is some boilerplate statement about receiving the training and understanding it. Some organizations take this one step further and have quizzes on the training material content to show effectiveness of training.

 

[Bev D]

What is the requirement for training records in medical device and pharma? Can someone quote it?

In general, mere attendance at a training does nothing to indicate that the ‘trainee’ understood what was trained, let alone actually implements it…This is just another example of useless ‘feel good’ evidence of competence…its more CYA than anything.

That said you can avoid value-less disagreements with an auditor by having the ‘trainee’ sign a training record. Welcome to bureaucratic waste: “sound and fury signifying nothing”.
personally, I think there is more evidence if the trainer enters the trainee’s name on the record. They know who at lleast paid attention and who didn’t. A ‘trainee’ can sleep or facebook or surf amazon instead of listening then sign anything even if says they are responsible - cuz it’s basically meaningless to them anyway…

But hey I’m just a pessimist about these things.

 

[yodon]

What is the requirement for training records in medical device and pharma? Can someone quote it?

As has been discussed many times before, the requirement is based on competence and training is just one way of achieving (or aiming to achieve) this. 13485 just says to maintain appropriate records of education, training, skills, and experience.

The much-debated "note" (is it a requirement or just informative) about checking effectiveness proportional to the risk associated work for which the training was provided is where a lot of this type of discussion arises. Maybe the company determines that effectiveness is suitably demonstrated by having the trainer sign off on the record (not advocating that, just something I've seen).

But back to the original question:

Would it be required, that this participation list is signed by someone, indicating the content of the record is correct and valid?

There is certainly NOTHING in the standard that would drive this.

 

[Rich S.]

You can use fork truck training as an example, a book written test is conducted, then an actual driving test is done to make sure they are proficient at driving the equipment, and follow the rules and techniques from the written material.

 

[ScottK]

But back to the original question:

There is certainly NOTHING in the standard that would drive this.

This is true - doesn't mean the FDA doesn't expect to see positive acknowledgement from the trainee in many cases. Unless things have changed in the last 8 years since I left that world. You can push back against an ISO13485 auditor, but not so much against the FDA.

 

[mattador78]

What is the requirement for training records in medical device and pharma? Can someone quote it?

In general, mere attendance at a training does nothing to indicate that the ‘trainee’ understood what was trained, let alone actually implements it…This is just another example of useless ‘feel good’ evidence of competence…its more CYA than anything.

That said you can avoid value-less disagreements with an auditor by having the ‘trainee’ sign a training record. Welcome to bureaucratic waste: “sound and fury signifying nothing”.
personally, I think there is more evidence if the trainer enters the trainee’s name on the record. They know who at lleast paid attention and who didn’t. A ‘trainee’ can sleep or facebook or surf amazon instead of listening then sign anything even if says they are responsible - cuz it’s basically meaningless to them anyway…

But hey I’m just a pessimist about these things.

We have that principal here i have a duplicate book and its signed by the trainer to say hes seen the trainee able to complete the task. Then signed by the trainee that they are comfortable in the task. Scanned on added to the training record and notations made in the skills matrix.

 

[FRA 2 FDA]

In addition to the usual and previously mentioned methods-having the trainee sign a training form, requiring the passing of a quiz, etc- I used to also do monthly spot checks where I would send someone a question about a procedure they were trained on, by indication on their training matrix, and require a written response back that I then saved as evidence that they had enough comprehension to answer a question about the procedure.

 

[Randy]

"Yep. I did the training and here's my signature. What was I supposed to learn about anyway? I didn't understand a blessed word, but I was there"