Not having Training Records for Documentation Changes - ISO 13485 Clause 4.2.3

I

ISO tired

#1
Our auditor wrote us a nonconformance for not have training documentation for every time time there is a document change. I cannot find the requirment for this. I thought that if the department heads/supervisors was signing the change document this would satisfy the requirement.
 
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A

arios

#2
Re: Iso 13485 4.2.3

Revised documents can introduce additional training needs. There are different types of changes which rank form minor typographical errors (on which training may not be needed), up to significant method changes (which could require training)

Document approval is occasionally used to demonstrate awareness, however the individuals who sign a change approval are not necessarily the ones who need to be trained, and this method alone may not be as effective as a more formal training. E.g. a supervisor may be approving a change, but his or her workers may not be aware of what the change was and the impact.

It would be beneficial to check how your training procedure explains that training needs will be identified.
 
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#3
Re: Iso 13485 4.2.3

Our auditor wrote us a nonconformance for not have training documentation for every time time there is a document change. I cannot find the requirment for this. I thought that if the department heads/supervisors was signing the change document this would satisfy the requirement.
OMG!:mg:

I'm guessing you don't have this in any procedure...do you? I have worked in a place where someone thought it was a requirement - turns out, she was 'making work' to keep from being terminated!

It's not a requirement of the standard, that's for sure, so your auditor sounds like they're over reaching, here. Time for a new one!
 
M

MIREGMGR

#4
Re: Iso 13485 4.2.3

On the other hand, as Arios notes, it makes sense and clearly strengthens your QMS and your company's operations.

So what's your goal: maintaining your certificate with as little work as possible, or...?
 
#5
Re: Not have training documentation for documentation changes - ISO 13485 Clause 4.2

Why is it that people insist on 'training' when a document changes? I don't understand. It has nothing to do with a 'better system' or anything like that. Training is only necessary when competency has not been demonstrated.

I'd agree that making some awareness of the changes is an important part of this change to a document, but not, repeat NOT, training! If you do, you'll soon bury yourself in a pile of records of, basically, nothing useful!

Auditors who ask for training after revisions to work instructions etc. are dinosaurs and deserve to be shown the door...
 
A

arios

#6
Re: Not have training documentation for documentation changes - ISO 13485 Clause 4.2

On the context of the Medical device sector, the ISO/TIR 14969 can be used as the guideline for the application of ISO 13485. This guideline document refers to "...follow-up or refresher training, as needed and planned"

On the context of the FDA's 21 CFR 820.40 we could also refer to the following requirement:

"Approved changes shall be communicated to the appropriate personnel in a timely manner"

So, I would not say this is necessarily a repeat training, rather it is keeping the people effectively aware of the relevant changes to their processes. The QSR also refers to: "ensure that all personnel are trained to adequately perform their assigned responsibilities". If the responsibilities change, then training is appropriate. This is why in my opinion this system needs to be robust. In the medical device sector the worst enemy could be one self, I mean, one self in case of un-compliance could have a person's life at risk, so I think it is worth the effort to apply training on prevention of mistakes.
 
#7
Re: Not have training documentation for documentation changes - ISO 13485 Clause 4.2

Our auditor wrote us a nonconformance for not have training documentation for every time time there is a document change. I cannot find the requirment for this. I thought that if the department heads/supervisors was signing the change document this would satisfy the requirement.
I read and understand. I just can't get to where you are making a case, from here...

If the auditor found some lack of awareness, some problems etc. then I'd agree, but it says 'every time there is a document change'. This is unqualified by a statement of associated risk, etc.
 
D

DrM2u

#8
Re: Not have training documentation for documentation changes - ISO 13485 Clause 4.2

:agree1:I second Andy's last two statement!:agree1:

There are no grounds for a finding unless you state the requirement for the specified training in an internal procedure. Challenge the auditor to quote where the requirement is stated and/or to provide evidence that failing to meet his 'expectation' has a negative impact on processes and/or customer.
 
J

Jason PCSwitches

#9
Re: Not have training documentation for documentation changes - ISO 13485 Clause 4.2

As already stated, unless you have this requirement in your procedures, it's not a requirement. That is why documents "shall be controlled, approved, reviewed, updated" etc.

Your document control procedures should ensure all changes are circulated to relevant departments. If deemed necessary (by you) then training may be appropriate. Listen to Andy...sound advise. :agree1:
 

somashekar

Staff member
Admin
#10
Re: Not having training documentation for documentation changes - ISO 13485 Clause 4

Our auditor wrote us a nonconformance for not have training documentation for every time time there is a document change. I cannot find the requirment for this. I thought that if the department heads/supervisors was signing the change document this would satisfy the requirement.
Yes, while any document change gets formalized we have a system to review if the change warrants a new training. If it is felt necessary the training activity about the new procedure is provided to the relevant people at the same time as the release of the new procedure and its training records follow. As we have experienced, most of the changes has not called for a training need.
Please see how you have addressed your training procedure.
 
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