Training Question

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
6.2.1 The organization shall establish quality objectives at relevant functions, levels and processes
needed for the quality management system.

The key part is relevant.

As Randy said, auditors have 2 options for a finding: A gap in meeting the standard or a gap in meeting what your documentation says you do. That is why the motto of "be as simple as possible but no simpler" is a balancing act between achieving your objective and creating confusion with too much detail.

Its your company with a context it defines. The auditor is an expert in 9001 but probably not in the market you operate
 

Paul Simpson

Trusted Information Resource
In the past we received an corrective action for not having employee completed training on their review. We had records of training, but the auditors stated that it was part of establishing goals and discussing what training they completed and setting goals going forward. I do not see that as a requirement in the standard, as long as we have a records. Does that fall under a different part of the standard?
It might help to post the text of the NC. There is lots of conjecture but we can only give you a full answer when we have the context of the question.

You can redact any personal or organisation-specific information, obviously.
 

Rob_Kellock

Involved In Discussions
Training Question

Maybe this is what you are being pinged on.

It's not enough to just show you have completed training. There is a requirement in this for the business to plan people's training, so they are suitable resources. Meaning if you decide someone has a particular role, you should be able to show what the training requirements are for that role. Then either be able to demonstrate that they are suitably trained or have a plan to satisfy that shortfall.

A similar approach to training, may also be required if requirements or processes change (which they inevitably do).

Then if you have a plan for training and fail to abide by it, sure you can pick up a non-conformance against your own plan.
 

Bev D

Heretical Statistician
Leader
Super Moderator
It is not documented in our process. I just wanted to make sure I interpreted the standard correctly. The auditor we had was extreme. I no longer use them to conduct audits. Thanks to everyone for reinforcing my thoughts.

Fay
Ok. Everybody read the OP’s response. And their original question. The requirement was not in THEIR documentation.

Their auditor wrote it up and that auditor is now gone.

The OP was asking if there was any requirement in the standard.

We can stop speculating about what might have happened.
 

Abena

Registered
Is it stated in your training/competence program or in any of your other documents/procedures/instructions? If it is, then you've shot yourself and only you are to blame (you being the organization).

I've played this game 100 times or more..........."It's not in the standard!!!!" "Yep you're right, but it is based on what you said you'd do in your own documentation" BAM!

Better look before you leap on something like this.

Others take heed........There's more to auditing than just "the standard".
like Fay said.... sometimes auditors dont fully explain thier findings , and if you push hard and they keep raising non-conformances that you believe are baseless, you can stop working with them and join others that would help improve your system not just ..........hunt for non-conformances.

"Others take heed........There's more to auditing than just "the standard".............i love this though.
 
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SeanN

Involved In Discussions
"Others take heed........There's more to auditing than just "the standard".............i love this though.
Well, I wanted to comment on this earlier... IMHO, auditing should be "just standards", but standards could be either externals (have-to), internals (want-to) or both. If it's not about standards (e.g. best practices somewhere, auditor's experience and observations somewhere else etc.) then there should not be any NCs, only OFIs at most.
 

Randy

Super Moderator
If it's not about standards (e.g. best practices somewhere, auditor's experience and observations somewhere else etc.) then there should not be any NCs, only OFIs at most.
Depends on one's definition of "standard"
 

Quality-Nation

On Holiday
Well, I wanted to comment on this earlier... IMHO, auditing should be "just standards", but standards could be either externals (have-to), internals (want-to) or both. If it's not about standards (e.g. best practices somewhere, auditor's experience and observations somewhere else etc.) then there should not be any NCs, only OFIs at most.
Could you re-run this thought? I’m totally confused by your comments which appear contradictory
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
Having training as part of personnel review is a terrible method to address competence. Training should be addressed ASAP and waiting for the annual review is not best practice. An auditor suggesting allowing an incompetent person to produce customer goods until their annual review is an idiot.
 

SeanN

Involved In Discussions
Could you re-run this thought?
Sometimes, the organization wants to do more (than what they "have to" to get certified), and they raise the bar for themselves by, referring to the original post, "setting training goals going forward." If it's the case, then "setting goals" becomes their internal standard and they have to walk their talk. If they don't, it's a NC.
To make it crystal clear, "setting training goals going forward." is not a must in ISO17025, but it makes sense for some organizations, then they take it as their (internal) standard.
Randy commented earlier that "Depends on one's definition of "standard"". This is a fair point, but without defined benchmarks, auditors face challenges in assessing conformity.
 
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