Training Due Date and Document Effectivity

[Murphymark]

We were recently pushed in an external audit to demonstrate that we train people to procedures prior to the documents being effective. How do you guys handle this? Do you have a process to set a future effective date on documents that align with training due dates, or are documents simply in-force and effective as soon as they are approved? There is nothing in the reg's that points to training to a document prior to the change being effective and we have always maintained that a person needs to train before they complete a particular task rather than before a documents effectivity date. We are all trained to many processes but don't necessarily execute on all of them all of the time, so if a document revises on a process that I am not currently executing on do I need to be trained to it before it's effectivity date? I don't think that I do.
I am just wondering what others do as I feel we may not be aligned with current practices. Thank you for any input that you can provide.

 

[John C. Abnet]

We were recently pushed in an external audit to demonstrate that we train people to procedures prior to the documents being effective. How do you guys handle this? Do you have a process to set a future effective date on documents that align with training due dates, or are documents simply in-force and effective as soon as they are approved? There is nothing in the reg's that points to training to a document prior to the change being effective and we have always maintained that a person needs to train before they complete a particular task rather than before a documents effectivity date. We are all trained to many processes but don't necessarily execute on all of them all of the time, so if a document revises on a process that I am not currently executing on do I need to be trained to it before it's effectivity date? I don't think that I do.
I am just wondering what others do as I feel we may not be aligned with current practices. Thank you for any input that you can provide.

Common question/conundrum @Murphymark ;
- Train BEFORE the document is 'live' (training on an inactive document?)
- Train AFTER the document is 'live' (risk someone using the prior/obsolete methods?)

There is no prescription within the standard as to how to manage this. Is there a risk within your organization in regard to how it is currently being managed? If so, address that risk.
If not, then articulate to the auditor how your organization manages this.

Remember, the auditor needs to be able to describe the requirement within the standard to which he/she identifying a gap. If they are unable to do so, then contest. i.e. why the "push".

Hope this helps,
Be well.

 

[FRA 2 FDA]

I also hate this conundrum. Here's what we have done. Once a document change has been approved, I initiate a training form and notify the process owner that changes have been approved and training can commence. When I get the training form back (I'm the doc controller and training coordinator) THEN I release the new revision. This way, if training reveals any last minute glitches or edits, they can be made prior to release and also all affected parties are aware of the changes before they are official. Successful so far.

 

[Golfman25]

Ah, so things happen in real time in the real world. So the question is -- why does it matter? You can have a document "effective" prior to implementation -- i.e.; doc is good to go, but people aren't trained yet. Heck, some times we even make a change before even officially documenting it -- the old "try this."

The question isn't about training. The question is whether the person is competent. Focus on that -- do they know how to process the changed procedure before pushing out "bad" product. If so, I think you're good to go.

 

[Quality-Nation]

We were recently pushed in an external audit to demonstrate that we train people to procedures prior to the documents being effective.

What kind of external audit?

 

[Murphymark]

It was TGA.

 

[Sidney Vianna]

In addition to the advice already provided above, check Document release vs its related training. Which should come first?

 

[Quality-Nation]

It was TGA.

I’m unfamiliar with this. Could you explain more?

 

[Bev D]

@Murphymark
There are many different phrases that can be reduced to the same Three Letter Acronym and many are unique to a single organization. Please decode the TLA…

 

[Murphymark]

Therapeutic Goods Administration. The Australian Governments regulatory arm. Their version of the US FDA if you like.