Audit Nonconformance - ISO 9001:2008 Clause 6.2.2 - Competencies

[Mark Meer]

...just for discussions sake...

If the Standard's requirement is:
"...determine the necessary competency for personnel performing work affecting conformity to product requirements...",
Then can competency be simply stated in terms of "conformity to product requirements"?
(especially in the case of positions with no educational or experience pre-hiring prerequisites)

For example, for assembly personnel, why require:

In order to build X personnel must:
1) be able to read and follow assembly instructions
2) be able to operate equipment Z
3) know the difference between materials A & B
...(any other details required for assembly)...


When it'd be so much simpler to just require:

Required competency: Able to build device X, that passes all final inspection criteria.
Evidence: During training session Y, personnel builds 5 units which pass all inspection criteria.

 

[Big Jim]

...just for discussions sake...

If the Standard's requirement is:
"...determine the necessary competency for personnel performing work affecting conformity to product requirements...",
Then can competency be simply stated in terms of "conformity to product requirements"?
(especially in the case of positions with no educational or experience pre-hiring prerequisites)

For example, for assembly personnel, why require:

In order to build X personnel must:
1) be able to read and follow assembly instructions
2) be able to operate equipment Z
3) know the difference between materials A & B
...(any other details required for assembly)...


When it'd be so much simpler to just require:

Required competency: Able to build device X, that passes all final inspection criteria.
Evidence: During training session Y, personnel builds 5 units which pass all inspection criteria.

As long as that is all they do that would be sufficient. Keep in mind that everyone needs to know the quality policy and how they contribute to achieving the quality objectives. There may be some other minor issues to cover as well, including some internal ones.

 

[AndyN]

...just for discussions sake...

If the Standard's requirement is:
"...determine the necessary competency for personnel performing work affecting conformity to product requirements...",
Then can competency be simply stated in terms of "conformity to product requirements"?
(especially in the case of positions with no educational or experience pre-hiring prerequisites)

For example, for assembly personnel, why require:

In order to build X personnel must:
1) be able to read and follow assembly instructions
2) be able to operate equipment Z
3) know the difference between materials A & B
...(any other details required for assembly)...


When it'd be so much simpler to just require:

Required competency: Able to build device X, that passes all final inspection criteria.
Evidence: During training session Y, personnel builds 5 units which pass all inspection criteria.

Because that's likely to be an over simplification...

 

[somashekar]

The word determine is telling us to decide in advance what necessary competency (some may call it minimum competency) is needed.
This can be a simple combination of Education + Skill + Experience
So for the personnel at all levels who can affect conformity to product requirement, the competency (necessary or minimum) has to be determined along with the position for the personnel.
The problem begins when the director wants his relative to be made the Purchase manager. The HR wants to recruit personnel who agree for the salary band that they can offer. This is where the necessary competency gets reworded to minimum competency. None can question the organization when the minimum competency is said as necessary competency.
This shifts a huge load on training or taking other actions to satisfy these needs. However as the necessary has become minimum, training becomes hugely ineffective.
What is required is again Top management commitment / clarity sincerity to the business and QMS.

 

[John Broomfield]

somashekar,

You say competence can be a simple combination of Education + Skill + Experience.

In post #6 above I say this accords with clause 6.2.2 in ISO 9001 but is incomplete when compared with normative definition of competence specified in ISO 9000.

Competence is a combination of ability + knowledge + skills. Abilities are inherent and include behaviors or attributes.

Training someone who does not have the requisite inherent abilities is a waste of time and money.

Although I do see how successful experience may be evidence of abilities. But I suggest it does depend on successful experience.

John

 

[Paul Simpson]

Hi, taboothu and welcome to the Cove.

You have had a lot of advice from others and it should help. I've noticed from your post that you are almost at the answer by yourself, though.

Hello.

During our ISO audit we were issued a nonconformance for 6.2.2. The Auditor wrote:

No evidence was presented to show that the organization has defined the necessary competencies required for production and inspection activities, although extensive evidence was present to show that training is provided and evaluated.

Not a particularly helpful nonconformity in terms of recording what evidence the auditor looked at and what gaps existed - ah well.

I am not sure how to answer this. We have job descriptions, a well established training program and were able to show records of training. And evaluations are done on an as needed as well as yearly basis.

Your JD might include elements of competence. Some do not and they only cover employment law type stuff. I'll cover training programme separately but the evaluations should definitely be the key to your demonstration of competence. If you keep records of the annual and 'as needed' evaluations this should satisfy the requirement to demonstrate competence.

You may need to clarify what elements the evaluations cover: laying wires, crimping connectors, wrapping harnesses, testing, etc. and you need to demonstrate that the evaluators themselves are competent (supervisor, lead operator, inspector, etc.)

He feels that our process for determining the necessary competence for personnel performing work affecting conformity to product requirements is not fully effective.

This comes back to what the evaluators are looking for. My experience with harness manufacture it is all about following the diagrams, accurate crimping of connectors, correct wires in the fixture, wrapping the finished harness and final testing.

There are more in terms of marking, labelling and special activities like water ingress prevention but this is a start and you will know best for your organisation.

Our training program establishes how to read drawings, follow work instructions and has a gold standard of how to build a harness and more that would take to long to type.

If anyone has any suggestions, I would greatly appreciate your feedback.

Thanks!

So to the training programme. The purpose of training is to build competence by developing knowledge or skills. So the things you train people in are the things you want them to be competent in doing. At the end of every training there should be some evaluation (to demonstrate the training has been effective) and this is also demonstration of competence.

Hope this helps and good luck.

 

[Big Jim]

So to the training programme. The purpose of training is to build competence by developing knowledge or skills. So the things you train people in are the things you want them to be competent in doing. At the end of every training there should be some evaluation (to demonstrate the training has been effective) and this is also demonstration of competence.

Hope this helps and good luck.

I refer to this as the "how do you know the spaghetti is fully cooked?" principle.

One of the simple time tested methods is that you pull a strand out of the pot and fling it against the wall. If it sticks, it is fully cooked. If it doesn't stick, it isn't fully cooked.

So a short time after completing training, usually within a month or two, the trainer approaches the trainee and flings them against the . . .

Not really, but you should get the picture. You observe his work and ask question about how and why he does things to confirm that the training was effective and that he now demonstrates competency for what was covered in the training.

Just don't break any arms or legs in the process.

 

[in_cr_ove]

Hello.

During our ISO audit we were issued a nonconformance for 6.2.2. The Auditor wrote:

No evidence was presented to show that the organization has defined the necessary competencies required for production and inspection activities, although extensive evidence was present to show that training is provided and evaluated.

I am not sure how to answer this. We have job descriptions, a well established training program and were able to show records of training. And evaluations are done on an as needed as well as yearly basis.

He feels that our process for determining the necessary competence for personnel performing work affecting conformity to product requirements is not fully effective. Our training program establishes how to read drawings, follow work instructions and has a gold standard of how to build a harness and more that would take to long to type.

If anyone has any suggestions, I would greatly appreciate your feedback.

Thanks!

your post has answer to your question.
Competency to read drawings
Competency to understand & follow work instructions
Competency to build harness
You may check whether these are addressed in the training. Also, how these are evaluated in training/ post training. Any data that shows that the participants in training have cleared a minimum benchmark will help.
Be prepared that the auditor may demand continual improvement in competencies.

 

[Andrews]

For each job profile, identify
a) minimum education- eg Diploma
b) previous experience if any required. - eg minimum 1 year
Check whether the person nominated for this job profile meets the requirement defined.

Then identify the skills required for this job. For eg, for a production operator it could be
a) Setup the machine
b) Usage of instrument
c) Resharpening of tools etc.
Rate the skill of the person nominated for this job on 4 points grading-
Level 1 - Incompetent
Level 2 - Able to perform under supervision
Level 3 - Can perform independently
Level 4 - Able to train others or lead

If the person is rated level 1 or level 2, then necessary training might have to be planned to bring them to level 3 or 4. Our aim should be bring most of the personnel to level 3 or 4.

 

[SpinDr99]

Sounds like Taboothu had presented sufficient evidence. An auditee has every right with a CB to challenge any finding they feel was not proper. Management at the CB will then review the finding and the evidence provided to the auditor and make their determination to upgrade, downgrade or eliminate the finding.