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Document release vs its related training. Which should come first?

Azhar Anwar

Starting to get Involved
#1
We have updated several SOPs in our QMS and performed related trainings after the documents have been finally released.
However, recently during an internal audit, We got a comment from the auditor that the training should be preceding the document release.
Meaning that the training should happen prior to the effective date of the controlled documents.

I am not 100% convinced. Can anyone comment on this issue please?
I have not found any previous posts related to this topic yet.
Many thanks.
 
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Mike S.

Happy to be Alive
Trusted Information Resource
#5
Interesting....I don't know or use ISO 13485 but I typically release documents then train to them. Otherwise, I'm training to an unreleased document.
 

Ninja

Looking for Reality
Staff member
Super Moderator
#6
I don't know or use ISO 13485 but I typically release documents then train to them. Otherwise, I'm training to an unreleased document.
All of that applies to me as well (including the "I don't know ISO 13485" part)

We released first, then trained.
In reality, we released first then DOCUMENTED training.
...folks were already aware that the change was coming, and already knew what the upcoming doc was going to say before it was released. We did not write docs and procedures in a closed room...we got input and reality checks before signoffs.
 

Jim Wynne

Staff member
Admin
#7
There is confusion here. We need to distinguish between documents and the processes they represent. The map is not the territory. If the document changes but the process doesn't, there's probably no need for training. On the other hand, it the process changes, the nature of the change(s) should govern when training takes place. I've always held to the idea that the changed process should be operated until it's confirmed (validated) that the change is viable and doesn't have unintended consequences. This is a accomplished by having a "beta" version of the process requirements, with full approval happening when the process change(s) have been confirmed.
 

RoxaneB

Super Moderator
Super Moderator
#8
Full disclosure - I am not familiar with your standard.

That said, does the standard state that training shall be conducted before document release? If there is no requirement for it, I'd question the value and validity of the finding.

Timing may not always allow for doc release before training...and, in my own experience, sometimes questions come out of the training that make us realize we need to add some things to the document to make it more fullsome.

My personal take is that unless there is a documented requirement that explicitly states the order your organization uses, I'd categorize this finding as baseless and move on.
 

Mike S.

Happy to be Alive
Trusted Information Resource
#9
Agreed, Ninja, it isn't a surprise when a new doc is released.

However, I have worked with a team creating a new revision, agreed on it, and then when it came signature time, someone said "I've changed my mind, let's completely change this section....". Had I trained to the doc before formal approval, I would have wasted my time and caused confusion.
 

contigo123

Starting to get Involved
#10
We take the view that training must be complete before using a new revision, and thus we usually do training after release but before the first time someone uses the new procedure. This helps in case someone is on vacation (or, more recently, out for covid related reasons) since they can train when they return. But we are a small company so it's easy for us to manage this, not sure if this works well for larger companies.
 
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