What is the best way to ensure retraining when changes occur? ISO 9001 Audit

[Chance]

Evaluation of each revision:
First, the Document Owner would have to evaluate if rereading/retraining is necessary with each revision of the document. (Sharepoint allows the Document Owner to make a comment beside each revision of a document - the comment could be 'no training necessary prior to annual review' or 'retraining required and implemented' or something similar.

I like this idea. I would just revise the document control procedure to specify that there is rereading/re-training, etc. required if necessary. In this case, you are only required to document the ciritical changes that requires further action.

 

[Sidney Vianna]

First, the Document Owner would have to evaluate if rereading/retraining is necessary with each revision of the document.

My only concern is that a document owner might not have as broad perspective as a process owner. I think that the process owner should be the one that makes a determination of the change impact and the subsequent need (or not) for re-training. Process ownership is something that few organizations exercise carefully but very important, in my opinion, and also suggested by ISO themselves in the Guidance on the concept and use of the process approach for management systems.

5.1.5 Define process ownership

Assign responsibility and authority for each process
Management should define individual roles and responsibilities for ensuring the implementation, maintenance and improvement of each process and its interactions. Such an individual is usually referred to as the "process owner".
To manage process interactions, it may be useful to establish a "process management team", that has an overview across all the processes, and which includes representatives from each of the interacting processes.

 

[MaureenT]

Thank you - I agree. The owner wouldn't necessarily know the impact the change will make elsewhere - I'll leave this to the process owner. Thanks so much.

 

[JaneB]

Evaluation of each revision:
First, the Document Owner would have to evaluate if rereading/retraining is necessary with each revision of the document. (Sharepoint allows the Document Owner to make a comment beside each revision of a document - the comment could be 'no training necessary prior to annual review' or 'retraining required and implemented' or something similar.

Yup, that would work (except make it Process Owner or department manager rather than doc owner, as already discussed)

Request of and Evidence of Rereading/Retraining:
When rereading/retraining is necessary the Document Owner would send a copy of the document (showing the changes marked) which contains the current revision/date, in PDF form. The recipients will be required to Sign/Certify the PDF electronically. Once all necessary sigs are obtained, the PDF signed by all can be saved to a folder on the Sharepoint site titled QMS Training Records.

This one sounds a little convoluted to me - can you not do it more simply than getting everyoneto sign off? eg, have 'someone responsible' verify that persons A-F had been re-trained & achieved competency? It's not just about doing training you see, there's a need to verify they're competent (ie, evaluate effectiveness).

Evaluation of effectiveness of training:
The QA Manager will have to design a few pertinent questions, and distribute the questions to all that signed the document. Once the responses are received, the QA Manager can add an evaluation on the bottom of the signed document.

Why the QM? Why not the trainer and/or person who oversees the people doing the work, ie their manager/line supervisor/whoever they report to, as per my preceding comment. (Unless the QA Manager is responsible for all training??) This sounds like generating lots of extra work for the QA Manager - is it valuable?

 

[MaureenT]

Thank you Jane - The QA Manager (me) isn't responsible for all training, the department managers are responsible for the initial QMS training of new hires. But since I'm the approver of all documents either in my role as Management Rep or QA Manager - in my proposed solution, I'd evaluate that retraining is necessary, the people that needed training would train, and I'd be able to evaluate if the training was effective.
For example, this one change effects DP01 - Documents and Records Control. I own this document and I'm the approver. The people that need to retrain to this significant change in the procedure prior to the annual review, are the other Document Owners - many of which are managers themselves.
Fortunately, significant changes to the procedures and documents aren't very frequent.
"can you not do it more simply than getting everyoneto sign off? eg, have 'someone responsible' verify that persons A-F had been re-trained & achieved competency?"
Someone will be verifying that they had been re-trained, and they verify it by seeing the signatures - this same signed PDF would also serve as a record, and would contain the evaluation.
Problem is that I need to let go of more, and need to have others be approvers.
Our internal auditors are the most equipped to be approvers, and I'll begin with them if we're granted recertification.

 

[JaneB]

Maureen,
I understand about wanting people to know & follow the doc control procedure & accept the argument there.

I may be misunderstanding, but are you in effect setting up yourself (or auditors) to verify that all training has been effective?? Why? (I cannot think, by the way, of a better disincentive for people to change documents!)

If so, this seems to me to be taking responsibility/accountability away from those who need to own it. Internal auditors ought to be auditing - and if that includes finding that there's evidence of lack of training/ineffective training, so be it. But why do you think they also ought to be verifying the effectiveness of training? Who is affected if it isn't effective? The department manager's ability to meet their goals? That's where the responsibility should lie.


You say you need to 'let go of more' - I'd aim to do that by making managers more responsible.

 

[fiona_young]

Can you get a READ/UNDERSTOOD/ACKNOWLEDGED as an automatic option from the predetermined individuals through sharepoint site, when they have accessed any new /changed document first time ???

maybe you can have a pop quiz after the change.....


we don't have to ensure every bit of thing in the work. That will drive people crazy. now that the change is small, i think necessary notification is enough.....if the change is big, then a training is "mandatory"

 

[MaureenT]

Of course, you're right. Thank you for making me look at it from another perspective. I've run into this before, but because of our current climate and structure of our company - control is taken by those that will take it. I think I can explain . . .
So, for example, if I determine that retraining is necessary due this major change in Documents and Records Control - and I notify the respective document owners because the change pertains to them (one is the vp of operations, one is the vp of sales, one is the human resources manager, two are auditors, one is the head of R&D, and me) - and they acknowledge they're re-read the change with the electronic signature: In another company, who would evaluate if training was effective (even if it was just a re-read)? In my company, for the VPs and head of R&D and human resources manager - their direct supervisor is the owner of the company. Although the head of the company very much supports our QMS, he is not about to evaluate if retraining to a specific document revision was effective. He loves the CARs and the Management Review Meetings, he ensures that we utilize an approved supplier list and evaluate suppliers, etc., but evaluating training in writing?
This is why it ends up here, with me.
Some things I can change, and some I'll have to work with, no?

 

[JaneB]

...he is not about to evaluate if retraining to a specific document revision was effective.

I'm with him.

I have to ask: is there really a need to evaluate that every piece of training to every single revision of every single document is actually needed? If so, what is that need and where is it coming from - ie, is there any evidence that such minute evaluation is needed? Because it sounds like overkill to me. I don't know your company, so it's hard to give advice, but this still sounds somewhat like overkill and microqualitymanagement.