Documented Evidence of Training ISO 13485: 2016

[indubioush]

A training record is, for the most part, inconclusive evidence of competence in anything.

A record shows objective evidence of conformance to quality system requirements. If there is a robust training process in which competence is assessed and documented, the record can show evidence of this.

Medical device manufacturers are required to "maintain appropriate records of education, training, skills and experience." "When product requirements are changed, the organization shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements." The management rep is responsible for "ensuring the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization."

What is the objective evidence that you are meeting all of these requirements?

 

[Sidney Vianna]

If there is a robust training process in which competence is assessed and documented, the record can show evidence of this.

This is NOT what the OP asked. The specific question was :

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

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.

 

[Zero_yield]

We have explicit records of every procedure every employee is trained on, including quality policy and the like. We have curricula for each job role to help ensure that each employee is trained on the procedures relevant to their role. I'm not really sure how you fulfill the requirements of 6.2 (f) in ISO 13485:2016 without maintaining records of training.

 

[Sidney Vianna]

We have explicit records of every procedure every employee is trained on, including quality policy and the like. We have curricula for each job role to help ensure that each employee is trained on the procedures relevant to their role. I'm not really sure how you fulfill the requirements of 6.2 (f) in ISO 13485:2016 without maintaining records of training.

So, self reading of a procedure for familiarization purposes is deemed training for you?

 

[Zero_yield]

Depends on the procedure. Initial training on a manufacturing process? On the job training 1 on 1 with a trainer. There's usually either a time requirement (i.e., 2 weeks / 80 hours) or a unit requirement (i.e., inspect 2,000 units with the trainer 100% verifying your work).

Minor wording update to an admin procedure you were previously trained on? Yeah, a self reading is all you need to be familiar with the changes.

This is in line with the requirements from 6.2:

The methodology used to check effectiveness is proportionate to the risk associated with the work for which the training or other action is being provided.

 

[Sidney Vianna]

Depends on the procedure. Initial training on a manufacturing process? On the job training 1 on 1 with a trainer. There's usually either a time requirement (i.e., 2 weeks / 80 hours) or a unit requirement (i.e., inspect 2,000 units with the trainer 100% verifying your work).

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

 

[mihzago]

Most companies I've come across require that employees are trained on all procedures applicable to them (in many cases even procedure that are indirectly related). I think they do it because it's easier and more convenient to administer and to demonstrate during the audit that training was performed, rather than creating training programs and recording completion. Over time it probably created expectation from the auditors that all employees responsible/involved in an activity must be trained on a procedure.

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? And isn't the whole point of a procedure to describe the activity and be available at the time I'm performing an activity?
Periodic re-training is another part of this that seems to be expected as well, and is a tremendous waste of time.

So, for companies that don't have a formal training program outside of procedures, and their training policy requires that applicable procedures are read (and maybe understood) by all employees, then probably have to show a proof that they did, but as others have said, it's not a strict requirement in the standard.

 

[indubioush]

This is NOT what the OP asked.

I was not responding to the OP; I was responding to you.

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.

How then do you show that an employee was made aware of a process change (as documented through a procedure revision)?

 

[Tidge]

The self-signing on read-and-understand is a perfectly acceptable, and common, approach by many companies subject to 13485 to be able to provide OE, as attested by each employee, that some (perhaps minimal) amount of training was done. It avoids all sorts of hearsay, he-said-she-said, and tap-dancing about the fundamental question "was a specific employee in question made aware of particular content of this Work Instruction at a certain time?"

We we provide instructor-led training, we require each attendee to sign-in... and the attendance sheet is further signed/dated by an instructor. Is this over-burdensome, no-value-added? I don't think so.

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.

 

[Sidney Vianna]

How then do you show that an employee was made aware of a process change (as documented through a procedure revision)?

Typically, when I was auditing full time, I would do it like this:

1. Identified a "recently" revised process specification, read through it and used highlighter and sticky notes to identify critical parameters revised.
2. Interviewed the process owner/department manager/line leader and ask how the workers involved with the process were made aware of the changes; typically, they would respond that a dept. meeting would happen and people would be made aware of the revision and changes. I would ask then if any of the employees were absent, how would they handle it.
3. I would then go to the floor where the process was actually taking place and interview a sample of the technicians involved with the process and ask:

• if they are aware of such recent revision to the process spec.
• can they access the actual document
• had they received formal notification of the change? (hopefully they would confirm the aforementioned meeting)
• what were the parameters changed, if any
• If they were not performing the process at the time of the audit, I would use the "please shall me how...." technique to confirm they are familiar with the process
• finally, if available, I would check records of the process run, since the last revision and compare with the parameters I had highlighted earlier, when I did my preparation.

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.