Pay attention to what Jim said. The issue is not training, nor documents. The issue is process control. And I stand by what I said in one of my posts on the first thread listed below:
Also, have a look at the two threads:
Document release vs its related training. Which should come first?
- Thread starter Azhar Anwar
- Start date
silentmonkey
Involved In Discussions
Agree with the above poster, it's about process control. Your process needs to assure that personnel performing work within the QMS are adequately trained in accordance with current procedures. So how do you assure that people are trained and competent when procedures are updated? Whichever comes first doesn't matter as long as the process is effectively controlled.
We used to have training after a procedure was published (made effective) but due to repeated non-conformities related to training not being conducted on time, we applied a corrective action and changed our process so that procedures were withheld from release until training was provided first. This was much more effective for us because the process owners could not release their updated process without giving training.
We used to have training after a procedure was published (made effective) but due to repeated non-conformities related to training not being conducted on time, we applied a corrective action and changed our process so that procedures were withheld from release until training was provided first. This was much more effective for us because the process owners could not release their updated process without giving training.
Azhar Anwar
MD fan
Thanks for all the replies. Apparently, there is no consensus regarding this subject.
And there is no, at least not that I know, specific requirement in the ISO 13485 either.
We also release documents (for both revised or new) first and then do the training afterwards.
Honestly, I did not think that this could be a significant issue.
But my auditor's reasoning is that if training is delayed until final document becomes available, there could be a risk that people would be following the outdated/wrong procedures/instructions, which could lead to non-conformities.
I think it all depends how significant the changes and their impacts are..
But if we take risk-based approach, he is actually right..
And there is no, at least not that I know, specific requirement in the ISO 13485 either.
We also release documents (for both revised or new) first and then do the training afterwards.
Honestly, I did not think that this could be a significant issue.
But my auditor's reasoning is that if training is delayed until final document becomes available, there could be a risk that people would be following the outdated/wrong procedures/instructions, which could lead to non-conformities.
I think it all depends how significant the changes and their impacts are..
But if we take risk-based approach, he is actually right..
Did the auditor cite this as a nonconformity, or just an observation?
Azhar Anwar
MD fan
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It was actually one of the recommendations. But we were asked to take them seriously.
I still think the auditor is all wet. As others have said, if the process is in control, and the training timing (either before or after formal document release) did not cause a nonconformance, what's the problem?
THere "could" be risk with either scenerio. What actually happened?
THere "could" be risk with either scenerio. What actually happened?
There appears to be consensus, but the problem is that there is no one-size-fits-all answer. It depends on the case at hand. People should be allowed to think about what they're doing, and understand the possible consequences. If you just roll everything into an amorphous blob and make a rule, you'll inevitably wind up doing unnecessary training, or worse, you'll finalize a process change without understanding unintended consequences. You can take a recommendation seriously without accepting it in the end.
Azhar Anwar
MD fan
Yes, I agree, so far the process is under control , and no related non-conformance.
Hi_Its_Matt
Involved In Discussions
I have personally seen both approaches implemented.
Company 1 took the approach of updating a procedure, releasing it, and having employees train to it. The caveat here is that their change control procedure said that process changes are expected to be implemented by the various sites within 30 days of a procedure update. So technically the procedure could be updated and sites would have 30 days to come into compliance. Employees had 60 days to complete the training, before they were considered "past due." This was a ~15k employee electronics manufacturer with more than a dozen manufacturing facilities around the globe.
Company 2 took the approach of a procedure change being "approved," then training conducted, then the procedure change being made effective. The company would require employees to train to approved updated procedures, but then would send a follow-up notification when all training had been completed and the change was made effective. This was a smaller, although still several thousand employee medical device manufacturer, with multiple global sites.
Neither of these companies had received significant external pushback (that I am aware of) about their chosen approach. Both were 13485:2016 certified.
As others have said, I think its ultimately about having a defined, consistent process that works for your organization, and making sure people follow it.
Company 1 took the approach of updating a procedure, releasing it, and having employees train to it. The caveat here is that their change control procedure said that process changes are expected to be implemented by the various sites within 30 days of a procedure update. So technically the procedure could be updated and sites would have 30 days to come into compliance. Employees had 60 days to complete the training, before they were considered "past due." This was a ~15k employee electronics manufacturer with more than a dozen manufacturing facilities around the globe.
Company 2 took the approach of a procedure change being "approved," then training conducted, then the procedure change being made effective. The company would require employees to train to approved updated procedures, but then would send a follow-up notification when all training had been completed and the change was made effective. This was a smaller, although still several thousand employee medical device manufacturer, with multiple global sites.
Neither of these companies had received significant external pushback (that I am aware of) about their chosen approach. Both were 13485:2016 certified.
As others have said, I think its ultimately about having a defined, consistent process that works for your organization, and making sure people follow it.
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