ISO 13485 Training Documentation example wanted

[joemar]

Glad to see that Elsmar Cove is back.

Does anyone have a copy of their training documentation I can see? For an ISO 13485 company?

I ask because I have been tasked to revise our training records format. Right now, they are having a hard time being both relevant and flexible. For example, entering new training events is difficult when there's a training to a new document revision. At the same time, the reason is that they wanted to standardize the trainings.

I was just hoping someone might be willing to post a template copy of their training form(s) so I could see how other people document a training event in a way that doesnt lose the historical trainings.

Thanks,

 

[Marc]

Maybe if you attach a copy of your current form some of us can critique it and give you some ideas.

 

[joemar]

Ok, Let me see if i can do that, removing the identifying information. But frankly, I was hoping to start fresh, because im not very happy with our current forms.

 

[joemar]

Hi All,

See attached. This is basically our training record form. The first page is generally used for the introductory training, where each new employee is to initial the standards that they were trained to. the second page is used to record updates, like updated forms they were trained to, or other things they have been trained to. they keep this form in their training folder and it's reviewed from time to time, and updated from time to time.

Basically, as stated before, I am hoping to revise this form in a way that makes it easier to track what has been trained, what needs to be trained, and flexible to take into consideration various new revisions or new documents.

Id love to see other people's training recording forms, if possible. or please let me know if you have recommendations on how to revise this one. Im a little hesitant in revising this one because im not particularly fond or it right now. I think it fails to really provide enough information for people to understand what training has occurred, and it doesnt provide clear instructions regarding how to use the form.

But Im open to hearing options.

thanks

 

[joemar]

any help?

 

[Mark Meer]

If it helps, I'll describe what we do:

Our 13485 training forms consist of a header (Record ID, Personnel Name), and a table with the following columns:
1. Process/Procedure (e.g. SOP-XYZ Documentation Control)
2. Key Points (all critical points that personnel must know regarding the process/procedure)
3. Initials & dates for the personnel and supervisor.

Our training SOP basically states that initials/date by the personnel and supervisor is an attestation by the employee that they are familiar with all the key points, and an attestation by the supervisor that the employee has demonstrated knowledge of key points, and is qualified to perform the duties relating to the process.

We maintain controlled training forms for each position, which may often have overlapping table rows (e.g. all forms include the same documentation control training item).

When a procedure is changed the following 2 things happen:
1. A one-time training form is created, to document only re-training on all items that were changed (we have a controlled template - basically just the same table-format, just with blank rows and a field to reference the associated change-record). All personnel impacted by the change are trained using this form, and the resulting record is attached to the original training record.
2. The controlled training forms are revised as applicable to reflect the change (so that the changes are incorporated into the training of future new employees).

Hope this helps!
MM

 

[Ronen E]

If it helps, I'll describe what we do:

Our 13485 training forms consist of a header (Record ID, Personnel Name), and a table with the following columns:
1. Process/Procedure (e.g. SOP-XYZ Documentation Control)
2. Key Points (all critical points that personnel must know regarding the process/procedure)
3. Initials & dates for the personnel and supervisor.

Our training SOP basically states that initials/date by the personnel and supervisor is an attestation by the employee that they are familiar with all the key points, and an attestation by the supervisor that the employee has demonstrated knowledge of key points, and is qualified to perform the duties relating to the process.

We maintain controlled training forms for each position, which may often have overlapping table rows (e.g. all forms include the same documentation control training item).

When a procedure is changed the following 2 things happen:
1. A one-time training form is created, to document only re-training on all items that were changed (we have a controlled template - basically just the same table-format, just with blank rows and a field to reference the associated change-record). All personnel impacted by the change are trained using this form, and the resulting record is attached to the original training record.
2. The controlled training forms are revised as applicable to reflect the change (so that the changes are incorporated into the training of future new employees).

Hope this helps!
MM

The "key points" approach seems a little strange to me:

1. Are there "non-key points" in your processes/procedures? If they're not important enough to be required for personnel qualifications, why don't you remove them?

2. The integration of the key points (or any other subject matter) into the training records creates double work when procedures are revised (as you've described).

In my opinion maintaining a training matrix (what roles need to know what) and blank training forms (filled for individuals when training occurs, to become personal training logs) is more efficient and simple. The details of any change and associated training / retraining can be easily (and quite efficiently) captured on the change control documentation. The individual training logs will serve as evidence that the prescribed training has occurred.

Cheers,
Ronen.

 

[joemar]

For the document I posted, it corresponds to an associated training matrix.

So looking at Mark's post, I need to create a second column of sign offs, as i like the redundancy. Also, my document needs to date locations.

Ronen, dont you end up with essentially an unlimited number of single line training forms, for when people are trained to a new revision? Or do your training forms have blank record areas that allow for the addition of new training events?

Also, how does each training log entry notify you that there was an associated form revision (for example)? Do you do each training to the entire revised form, or just to the areas of the form revised?

Im just trying to learn the detail that people put into these, so I can best rebuild my form.

Thanks

 

[Mark Meer]

The "key points" approach seems a little strange to me:

1. Are there "non-key points" in your processes/procedures? If they're not important enough to be required for personnel qualifications, why don't you remove them?

2. The integration of the key points (or any other subject matter) into the training records creates double work when procedures are revised (as you've described).

The reason for this approach is that "key points" may differ from position to position.

For example, everyone needs some training on documentation control. However the sections of our SOP dealing with requirements for electronic records are simply not applicable to positions that don't deal with electronic records.

The evolution of this system was a result of noticing people would be overloaded with information (much of it not applicable to their roles) if we simply mandated general training on a particular procedure. By focusing only on the key points relevant to their position, people are much more likely to assimilate the necessary knowledge. I've found this to be much more efficient and effective.

With respect to "double work", note that I say the position training forms are revised only if applicable. For example if a "key point" on the training form is "knowledge of current backup requirements for electronic records", then if the requirements are changed, the training form does not need to be updated, as future employees in that position will always be trained on the current requirements. ...in such cases all that's required is to document that people previously trained on the old requirements are now trained on the new ones.

 

[JoShmo]

When I read that people do training to a document revision, I shudder. Why would you do that? Let's go back to some fundamental prnciples here and look at competencies and ask what we need to train in. Do competencies change when there's a doc rev? Probably not. Instead of worrying about the record format ask yourself what is going on with training first.