Documented Evidence of Training ISO 13485: 2016

[Ronen E]

But, what's the point of assigning dozens of procedures (sometimes over 100) when onboarding someone? How much of it they're going to retain?

Hit the nail straight on the head!

Reading a procedure =/= training. Not really. Though officially it will fly with most auditors, who just want to tick the box and go home!

Further, how can anyone tell whether someone "understood the procedure" without interviewing and challenging them?... Simply by observing a declaration "I have read and understood..."?
This is one of the worst and most ridiculous, but well-seated, follies - at least in medical devices (which is the industry I'm familiar with).

Also note: "Familiar with..." =/= "Aware of..." [the existence of? the location of?] =/= "Aware of the contents of..."
They are totally different from each other, and require totally different levels of resources investment.

 

[Ronen E]

should the company in question end up with serious QMS issues due to lack of training or inconsistent application of existing procedures.

... And ticking a box that a-certain-one-out-of-67-procedures was (supposedly) read "and understood" within the first month of hiring is going to effectively combat those "serious QMS issues"?

 

[Tidge]

Context my dear fellow:

Intentionally keeping a system where there is no objective evidence that employees are trained to procedures (updated or otherwise) certainly strikes me as an opportunity for improvement... in the absence of other issues that may have training as a potential root cause... otherwise, as I wrote above, it likely would rise to the level of evidence of non-compliance. Let's not rule out that an auditor may have brought this up NOT because "they know what's best" but because they don't want their reputation tarnished should the company in question end up with serious QMS issues due to lack of training or inconsistent application of existing procedures.

It's not as if the hypothetical auditor mentioned is going to give 67 performance assessments to the one-month employee trained on 67 procedures.

 

[Quality_Goblin]

My response to the original question is: Yes. In my assessment, the 6.2 says you have to provide appropriate training, and you have to document that training. It's up to the organization to assess what the proper level of training / certification is for each process they're training employees on.

If your organization believe reading a document and becoming familiar with it is an appropriate level of training for certain procedures, I would agree, and I would interpret the requirement as saying you should document that training. If it is not an appropriate level of training as some have alluded to, then I'd recommend developing a more robust training and document that. We actually have a fairly lengthy onboarding process now (~1 week) because there are so many basics people need to learn before touching product, and just reading SOPs wasn't cutting it.



I would agree with doing all of these steps when auditing a process. I think you're definitely doing your due diligence here in evaluating that the QMS was effective at implementing changes. I'm not saying that a training record is inherently proof of a functional QMS or change control process. I'm just saying I interpret documenting training as required ISO 13485, and one piece of evidence that necessary information is getting to right people.

I am still very new to creating a training program. So I am curious what you consider a robust onboarding process?

 

[Funboi]

I am still very new to creating a training program. So I am curious what you consider a robust onboarding process?

One which achieves what management want from onboarding? It’s not difficult. Robust just means it works most of the time. What “works” in managements’ eyes? Speed? Retention? Achievement of competency?

 

[Zero_yield]

I am still very new to creating a training program. So I am curious what you consider a robust onboarding process?

Obviously, this is going to depend heavily on your process and product, but a few goals I would keep in mind are that new technicians understand:

1. The basics of how their actions could affect a real patient.
2. Documentation is important and how to document their work.
3. The need to ask questions when they don't know what to do and how to get questions answered.
4. The need to report issues if they see something wrong and how to report issues.
5. General requirements of work in a controlled environment (proper garbing, not bringing in items from the outside, etc.).

Plus hands-on training on their first real process for at least a couple days (including how to work safely, depending on the process).

We get plenty of new technicians who are fresh out of high school or have 10, 20, or 30+ years in some other industry (construction, food service, retail, etc.). There's a lot of expectation setting if we want people to feel confident and hit the ground running in what's usually a very strange environment for them.

If/once you have an onboarding program, keep on the PDCA cycle (plan/do/check/act). What problems do you always run into with new technicians? Say they have high levels of handling damage - maybe handling training should be part of the onboarding, or the handling training in the onboarding could be improved. Check in with new technicians after 2 weeks, 1 month, 3 months. What did they not realize when they started the job, or what did they have to learn by experience?

Just like any kind of continuous/incremental improvement process, you're probably never going to get to the point where a technician fresh out of training functions at level of a technician with 10 years of experience, but you can always get the next crop of onboarded technicians better prepared than the last ones.

 

[FRA 2 FDA]

As the quality/HR person here, I handle the general onboarding. I created a PowerPoint that gives a general overview of our product, some facility information, and an introduction to the concept of quality and how it relates in a real-world way to the new employee. I also created a presentation about real-world examples of when companies have skirted quality and the resulting impact because I acknowledge that quality can seem like a nitpicky hassle that just slows you down and that it's easy to lose sight of the big picture of why it matters when you're immersed in your little day-to-day bubble and just trying to get the freaking job done. On day one, I present these to the new employee then go over document and record control procedures and have the trainee take the quiz. Now they've already checked off two of their training requirements! Then I turn them loose with their area manager who handles job-specific training.