Does training have to be written?

ISO_Man

Involved In Discussions
#1
I had a CAPA against an uncontrolled document in use in my plant, and I want to know if training on the use of the new document needs to be written? Or is verbal training and a signed training record enough?
 
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RoxaneB

Super Moderator
Super Moderator
#2
I'm a bit confused as to what is the issue. Is the finding against the fact that an uncontrolled document was in use? Or is the finding against how training was completed on a new document? I think I'm confused because you say "uncontrolled document" and "new document" and I'm not sure how the two align.

All that said, the standard doesn't say how to document the nature/content of the training, so what does your own internal process require?
 

ISO_Man

Involved In Discussions
#3
The document was uncontrolled which was the non-conformance. A new document was created and released the appropriate way, and then training was provided verbally on the use of the new document and a training record was signed by the employees who were trained as evidence of the training.
 

ISO_Man

Involved In Discussions
#4
The document was uncontrolled which was the non-conformance. A new document was created and released the appropriate way, and then training was provided verbally on the use of the new document and a training record was signed by the employees who were trained as evidence of the training.
Our internal process doesn't specify that training has to be written, but I don't to get worked over by the next auditor.
 

RoxaneB

Super Moderator
Super Moderator
#5
Maybe it's a language issue and if so, I do apologize, but why was a new document created? Why not simply create a controlled version of the existing document? Or was there information on the uncontrolled version that needed to be incorporated into a new version?

Either way, the standard does not tell you how to train. What it looks for is effectiveness of the training usually demonstrated through competence. Competence can be measured by any nonconforming outputs of the process.

So, if the document is "How to Operate Machine B"...and the team(s) that use Machine B have 0-some organizationally-determined acceptable number/rate of defective products, then essentially have competence, meaning the training was adequate.
 

Ajit Basrur

Staff member
Admin
#6
If I understand you correctly, you have a training record signed by the employee. This serves as an objective evidence of training and should be good enough.
 

Mike S.

Happy to be Alive
Trusted Information Resource
#8
Verbal training with a record thereof is fine.
Exactly.

Training could be written, video, live demonstration, verbal, or any combination. What matters is did the training accomplish it's goal of adequately conveying the information.
 
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