Training Documentation - Control of Signed Training Documents e.g. Training Logs

We are implementing a new HR system that allows us to track our training via computer as part of the HR files. The question I have is related to signed training documents such as training log sheets, etc that are signed by the employees at the time of training. Are we required to retain the signed copies once the HR system is updated to show that the employee completed the training? My answer is yes, but I would like to know how others are handling this. We cannot scan the form and attach as part of this sytem. Of course we can upgrade to get that function, but that is another story.

I see no requirement for original signatures anywhere on training records.

ISO 13485:2003 requires you to "maintain appropriate records of education, training, skills and experience."

21 CFR 820.25 simply states, "Training shall be documented." 820.180 which deals specifically with records doesn't address this at all.

Unless you have other regulatory documents that I'm not familiar with, I don't believe you need to keep the original records.

Legal Protection

For a quality system you might keep the signed copy until info is entered into the computer.

You can still show a registrar how the system works.

But now I am in court five years later and the judge asks me what evidence I have that the worker who lost his hand was trained in the safety of that machine.

Much better to have his signature than a printout from a computer.

I don't care about signatures. It might show that someone signed the paper, but it doesn't mean that they actually attended the training (I've known cases where someone signs in and then leaves). It also does not mean that if the person attended, that the person learned anything.

ISO 9001 requires you to keep appropriate records. That gives you lot of room. Because training is meant to change behaviors, I think that keeping records of the changed behavior is the best record. That means, keep records of the output of the work associated with training.

Since several years we do not keep signed records of training. Training is documented in a coputer system. There is actually no need for signed records.
But we have one exception to this rule. We do keep signed records for training/ instruction on safety items. Employees have to sign that they received and understood the training/ instructions.

I'm with Dave on this one, but I'll say it another way.

Don't invent a new solution when an existing one will work. Training is a process just like any other. You have inputs (the trainer, the trainee, and the training materials) you have process steps (the presentation) and you have outputs (the trainee with modified behavior).


If you have an assembly process and you need to know that a particular screw was installed in every unit, you wouldn't record that the unit went through the "screw installation work-cell" right? You would want evidence of the installed screw! Same with training. You design the training materials and presentation, you validate that the training process itself is effective if applied as designed, and then you verify that an employee was trained with a validated test for the characteristic that was added in the process, i.e. the desired behavior.

Now your training records are objective evidence of the desired behavior, not that the trainee went through the training. Maybe an actual administered test, maybe a process metric they are responsible for. Yes, designing tests is a job in itself, and the test itself has to validated, but in QA don't you constantly design and validate tests already? Same thing.

Do this, and then if you have to refer back to the training records (why else would you keep them?) you have objective evidence that the employee had the required knowledge because they exhibited the behavior as desired. The record is then authenticated by the person doing the verification test, not a list of illegible employee signatures, and you can stand up in court (if it comes to that) and say "Here is proof that employee X knew Y, and therefore had been trained." How do you know the test applied verifies what you claim? Provide evidence of the original validation of the test itself, or better yet re-run the validation of the test.

Incidentally, the above also gives you a water tight alternative to "grandfathering" employees WRT training requirements.

MikeL said:

<snip> But now I am in court five years later and the judge asks me what evidence I have that the worker who lost his hand was trained in the safety of that machine.

Much better to have his signature than a printout from a computer.

Click to expand...

This type of scenario has been proven to be very important over the years. If someone signs something, such as "I took this course", even if they learn nothing (as would be the case of their leaving early), I want that signature maintained. If nothing else it proves the company provided the training and the employee is stating they took it. Whether the employee decided they really didn't need it (for example) and didn't finish (left or what ever), they have stated that they did in fact take the course.

As to training effectiveness, when I used to do training I *always* had employees take a test, which they signed. There are variations on this theme even in On The Job training.

As an illustration: Let's say you draw up a contract which you (and probably others) have to sign. Would it be valid in court if the signed contract had been input into a computer file with a note that John, Fred, Mary and Louis signed it, and the original with the signature(s) was destroyed? Any proof that they actually signed the contract is forever lost. Not to mention, the content of the contract that they actually signed is also lost forever.

Any document which is required to be signed is required to be signed for a reason. If there is no reason to require a signature, why would one ask for a signature in the first place?

Marc said:

This type of scenario has been proven to be very important over the years. If someone signs something, such as "I took this course", even if they learn nothing (as would be the case of their leaving early), I want that signature maintained. If nothing else it proves the company provided the training and the employee is stating they took it. Whether the employee decided they really didn't need it (for example) and didn't finish (left or what ever), they have stated that they did in fact take the course.

As to training effectiveness, when I used to do training I *always* had employees take a test, which they signed. There are variations on this theme even in On The Job training.

As an illustration: Let's say you draw up a contract which you (and probably others) have to sign. Would it be valid in court if the signed contract had been input into a computer file with a note that John, Fred, Mary and Louis signed it, and the original with the signature(s) was destroyed? Any proof that they actually signed the contract is forever lost. Not to mention, the content of the contract that they actually signed is also lost forever.

Any document which is required to be signed is required to be signed for a reason. If there is no reason to require a signature, why would one ask for a signature in the first place?

Click to expand...

To be clear, signatures can be beneficial for legal purposes, as Marc described. ISO does not necessarily require them, though they can be useful. The requirement is to show objective evidence that an evaluation of competence has been performed, and the results. There are many ways to do this, and tests, sign-offs, etc., are good examples of this.

Pay close attention to JABee. Your Learning Management System must be validated.

Does anyone have an example of the language on the training sheet employees sign? Something like "by signing this sheet I agree to....."

I am also trying to clean up this part of our quality system. It has been lacking and is just a matter of time before the auditor dives deeping into this area. We have been going on the honor system, but I do not believe it has been working.