ISO 9001 Clause 6.2.2 - Training Records, a Job Skills Matrix and Job Descriptions

[Jim Wynne]

On this we will need to agree to disagree.

Your own statement indicates competence is evaluated by observation of process and results. What is a result if not a metric?

The presence of competence cannot be quantified, except perhaps in binary fashion. It either exists or it doesn't. In order for a useful metric to exist, you must be able to quantify (i.e., express in numbers) the thing being counted or evaluated.

 

[RoxaneB]

The presence of competence cannot be quantified, except perhaps in binary fashion. It either exists or it doesn't. In order for a useful metric to exist, you must be able to quantify (i.e., express in numbers) the thing being counted or evaluated.

And since the requirement is to demonstrate that folks are competent it is up to the organization to determine how they will demonstrate conformance to this requirement.

I suppose one could argue that the CEO stating "all of our employees are competent" is their process. But even that is a metric as the CEO either says it or does not.

One could also offer that the defect rate (i.e., the lower the better) is how they demonstrate that folks are competent (i.e., following the training), but this would also need to ensure that defects caused by events/activities not related to training are removed from the equation.

Either way, a metric will exist - what may be debatable is the relevancy/suitability of the metric as a means to demonstrate competence.

 

[Jim Wynne]

I think what you mean might be "criterion" or "criteria." If something can't be enumerated, it's not a "metric."

 

[RoxaneB]

I think what you mean might be "criterion" or "criteria." If something can't be enumerated, it's not a "metric."

When you are assessing the conformance or achievement of "criterion" or "criteria", you can easily turn the assessment result into a metric. It doesn't need to be numeric.

"Conformance is demonstrated by a statement from the organizational CEO."

Q1 -- Target = Yes | Actual = Yes
Q2 -- Target = No | Actual = No
Q3 -- Target = Yes | Actual = No
Q4 -- Target = No | Actual = No

Using the red/green colouring system, it would be easy to visually demonstrate if the non-numeric target was being met for the quarter. Yet when we discuss the actual results, numbers come into play...achieved target for 3 of the 4 quarters, although only 2 quarters required a statement and this was done 50% of the time.

BTW, do not tell me what you think I mean.

We are now discussing the minutia of the issue and have likely wandered off topic. @Wolf.K wanted to know:

how do you check the competence according to ISO 9001 requirements or other ISO standard requirements? We have a similar matrix, but we list all our SOPs and check, which SOPs each employee needs to know, and to what level of knowledge.

I'd offer that the easiest and simplest way to assess competence is to look at the SOPs and consider why they exist (i.e., what they are attempting to achieve or avoid). If that achievement/avoidance is being met - i.e., the results (be it a metric or criteria or whatever you wish to call it) of the process are being met - competence is likely well on its way to being demonstrated.

 

[Wolf.K]

I'd offer that the easiest and simplest way to assess competence is to look at the SOPs and consider why they exist (i.e., what they are attempting to achieve or avoid). If that achievement/avoidance is being met - i.e., the results (be it a metric or criteria or whatever you wish to call it) of the process are being met - competence is likely well on its way to being demonstrated.

If we link this to the CAPA, Internal Audit, and Change Request processes, we could have results like "zero problems occured in process X, therefore we can conclude that people involved in process X are competent".

 

[RoxaneB]

If we link this to the CAPA, Internal Audit, and Change Request processes, we could have results like "zero problems occured in process X, therefore we can conclude that people involved in process X are competent".

My cautionary note to that approach is that those 3 processes are heavy on reacting to metrics - yes, I see the P in CAPA and a Change Request could be preventive in nature but they are, from my own experience, more in reaction to a trigger of some sort. A regular review of results - dare we call this some of Management Review and Process/Production Control??? - allows for a more real-time assessment of the results-against-targets, a more proactive approach to the results, and less lag-time if responding to a target-not-met scenario.

 

[Enghabashy]

comprehensive & overall Tr. & competence sheet

 

[Jim Wynne]

comprehensive & overall Tr. & competence sheet

Do you have a question? Are you looking for a training log?

 

[Nicole]

View attachment 26261

Hello - would you be willing to share your excel spreadsheet? Nicole

 

[Emmanuel H.]

Outstanding Matrix,

BcHioukh / Wolf K could You share the related Competency Matrix Template on a Excel Format, Thank You

It will be so helpful to assist in the establishment of Competencies in compliance with ISO Clause 6.22