Documented Evidence of Training ISO 13485: 2016

[Zero_yield]

Sorry, but you are circumventing the actual question the OP asked, and I will not repeat here.

However, my question is; Is there a requirement to show proof that this person has read the applicable procedures or work instructions.

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.

To me, this would give me much more confidence that the changes have been communicated and implemented; something that looking at a training record would not.

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.

 

[QualAl]

No, there isn't. You might have encountered an auditorsaurus rex disguised as a CB auditor. Some of them have archaic, inane expectations and roam the plains of the RegistrantWorld seeking auditee prey, instead of performing value added conformity assessment jobs.

Push back. Forcefully. As you don't want an external auditor forcing you to spend time, money and effort in valueless bureaucracy.

Hi Sidney,


Thank God this auditor is not a Auditsaurus rex. But in fact it is a customer audit, who is not qualified as an auditor. I don't even know if they know how to audit. An audit should be based on a clause in which you have not met. I myself is a certified Lead Auditor and I've never heard of such things in my 20 something odd years such as this. I checked and search the web and I've never seen such requirement. But I don't know how to react. I'm stuck in a hard place and a rock. because this customer just gave us a large contract. So, do you please and move on. or push back and possibly lose this contract. Or navigate it with the customer and turn it into a Opportunity for Improvement (OFI).

Thanks,


Alan

 

[QualAl]

This is NOT what the OP asked. The specific question was :
Most organizations that I am familiar with, including medical device manufacturers, have an onboarding process to make employees familiar with the processes (beyond procedures) they will be involved with, but very few demand a record of such familiarization.

Sidney,

Here in my company, we have an onboarding training prior to starting any jobs. The new hire is given a full training of the requirements including the health and safety protocols. and finally an exam to measure how effective was the training. If should the training is not effective, then a brief review of the technical issues with the new hire. And all this is documented in black and white. If should the new hire passes, then a certificate is given to the new hire. and then, is onto the mentoring and on-the-job training. However, when this audit required us to have objective evidence that everyone including the President downwards read procedures and work instructions. This is absurd. Training materials like procedures and work instructions are given to the operator to read prior to the operation or activity. but not before, especially, if the president doesn't even touch any assemblies or manufacturing jobs. I can see everyone must read the Quality Policy, and understand it. I have taken signatures showing proof that they were given the opportunity to understand it. But everything else. it's not required until they need it.

Alan

 

[Ed Panek]

We have a matrix per job determining training requirements. Each position varies. The training section on CFR 820.30 Design Controls includes a short quiz per section. The quiz is open book and not terribly tough.

For auditors who push further we rely on our finance team. How? Well, we ship our products to our customers who ultimately test each one. They pay us for them. Our Evidence our entire training program is effective is two fold. One, we have lower trending per capita complaints and two, our customer pays us for them. Payment ultimately indicates from the customer that our training is effective.

 

[QualAl]

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.

Hi Zero_Yield,

I would agree that having objective evidence is a requirement to show proof that training was conducted, however, if an operator doesn't need to read that particular procedure or work instruction yet or is not performing that particular job. Does he or she still need to read it? Maybe he or she will never do that job or activity. Then what? What happens if there are changes later, does he or she have to read it again even though they will never perform that job function. I'm only saying that we only provide procedure or work instruction at the time when the job is being performed. This way it is fresh in their mind and not many months before. Yes, there are some training that does need to be trained up front before and those are the basics like health and safety as well as knowing where to find these documents and work instructions. The Quality Policy, the quality manual is another.

And as you said " Provide appropriate training" We do provide appropriate training to all our employees. Including staff on any changes. However, I understand that some companies onboarding process may be very lengthy and complex but our onboarding takes two days, plus an exam, to verify effectiveness of the training.

Alan

 

[Zero_yield]

QualAl, after your elaboration, I agree that the auditor is being goofy. I think there's probably a curated list of procedures every new hire needs to be trained on (like the Quality Policy, as you mentioned), but the list is not "every procedure they might ever encounter." A new finance hire doesn't need to know how to work a piece of production equipment, they need the finance procedures. A new production technician doesn't need to know every operation in the plant, they need to learn each manufacturing process as they're assigned to it.

If your auditor is saying the president of the company needs to know how to weld two widgets together, they've been watching too much Undercover Boss. Do they think the CEO of Johnson and Johnson is trained on how to make Band-Aids, Tylenol, contact lenses, and vaccines?

As far as training someone on it at and retraining them on it indefinitely, we periodically prune the list of procedures each associate is trained on to avoid unnecessary trainings. When I worked the floor as a production tech, I was trained or certified on all sorts of production processes. Now that I'm in quality engineering, I'm trained on procedures relevant to my area (change control, nonconformance investigations, CAPAs, etc.), and they've cut all the manufacturing processes from my curricula. If I ever went back for some reason, I'd need to retrain/recertify on all of them to get caught back up with any changes that happened when they weren't part of my role.

 

[QualAl]

We have a matrix per job determining training requirements. Each position varies. The training section on CFR 820.30 Design Controls includes a short quiz per section. The quiz is open book and not terribly tough.

For auditors who push further we rely on our finance team. How? Well, we ship our products to our customers who ultimately test each one. They pay us for them. Our Evidence our entire training program is effective is two fold. One, we have lower trending per capita complaints and two, our customer pays us for them. Payment ultimately indicates from the customer that our training is effective.

Hi Ed,

Would you be willing to share a copy of your matrix, so that I can see how you determine your training requirements. You can send me a private email at '[email protected]". Thanks, Alan

 

[Ed Panek]

ST Self taught
IL Instructor Led
CBT Computer Based Training
OT Offsite Training

 

[Tidge]

Not specific to training, but this bit reminded me of some dangerous thinking I encountered in the past:

For auditors who push further we rely on our finance team. How? Well, we ship our products to our customers who ultimately test each one. They pay us for them. Our Evidence our entire training program is effective is two fold. One, we have lower trending per capita complaints and two, our customer pays us for them. Payment ultimately indicates from the customer that our training is effective.

I once knew a senior guy whose default rationale for not doing user validations (or making design changes, or doing much of anything else...) for finished goods was "as long as customers are paying full price, why do we have to bother (with _____ ) ?"

 

[Ed Panek]

I once knew a senior guy whose default rationale for not doing user validations (or making design changes, or doing much of anything else...) for finished goods was "as long as customers are paying full price, why do we have to bother (with _____ ) ?"

Agreed.