Training records and levels - When does training NOT need a record?

ISO_Man said:

How are changes communicated to the users of a procedure?

Click to expand...

Are you asking about "communication" or "training", or do you think both are always the same?

ISO_Man said:

How are changes communicated to the users of a procedure?

Click to expand...

By an effective document control system! As we see in many posts here, particularly regarding changes to documents, we constantly hear that revisions etc must be on the document so the user will know - instead of looking at the process and understanding how the revision (not just an identifier) is communicated. Most totally overlook that aspect of it...

ISO_Man said:

I don't really understand your comment. The training is default because by changing a procedural document you are introducing a change into the process and the people who use the procedure need to know that. So communicating the change to them can take different forms, but in the end they need to understand and communicate their understanding so some kind of response needs to be recorded.

Click to expand...

Case 1 : You have deputed 3 of your employees to be trained on a new process and maintenance of an equipment at the site of the machine manufacturer. They will be responsible for the operations and maintenance. A training record has been made after the visit and training certified by the manufacturer.
Now after three months, that equipment is installed and commissioned, and you make a new documented procedure. The competency is already established before the procedure. You do not need to make a training record after the procedure is made. In fact the senior of the three trained persons would have been involved in making and approving the procedure.
Case 2 : You make a change in the procedure based on the inputs and suggestions of the operators after evaluating the same. The operators agree that this change is valid and improves the work efficiency. Why would you make a training record when you know the competency is already established.
So any new procedure or change to a procedure does not need a new training record.
A new or a changed procedure needs an evaluation of the new or improved competency necessary.

ISO_Man said:

OK - here's one for discussion.

I'm introducing the idea into an organization that when new information is documented, the QTBA (Question To Be Answered) is "does this document require training?" The lesson that I'm trying to socialize is to address this question from the perspective that if you're creating a new process, introducing a new tool etc. then it almost always needs some level of training.

And for every level of training - we need to know that it happened.

So - in your experience - when does training NOT need a record? I'm feeling like the answer is never, but I'm open to some counter-point here.

Click to expand...

Hi,
As far as we go by the standards requirement, ISO 13485:2016 clause 6.2 e) maintain appropriate records of education, training, skills and experience (see 4.2.5).
The word "appropriate" has its own definitions.
You can define which training needs records and which does not.
However any training related to product safety and efficacy, competency needs to be recorded undoubtedly. (E.g. Sterilization process, manufacturing process, testing process, ISO awareness etc.)
But training that are not directly going to affect product quality and safety shall not be recorded. (E.g. Soft skills, team management, Even GDP, etc.)
But as I said you need to define whats "appropriate" for me its product safety and efficacy when it comes to medical devices.
Hope it helps.