Audit Nonconformance - ISO 9001:2008 Clause 6.2.2 - Competencies

[taboothu]

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!

 

[the47guy]

Re: 6.2.2 non conformance ISO 9001:2008

Hey Taboothu,

We put a blurb in our Quality Manual that states:
The Company identifies the requirements for education, qualifications, and experience in the individual job position descriptions. Each employee’s qualification is verified by Human Resources prior to hiring or promoting into a specific position, which ensures competency and satisfactory compliance with these requirements.

To add to this we also have a procedure just for 6.2.2 that states what criteria inspectors need and so forth. The entire procedure is not required but it worked for us given the amount of positions and duties we have on sight. Here is some of the criteria we use for competency.

Necessary competency requirements are identified by, but not limited to, the following:
? Dictated Statutory and/or Regulatory Requirements based on published safety/operational codes such as; OSHA safety standards, local fire department restrictions, or requirements for handling and disposal of hazardous materials
? Company orientation and training requirements identified by Human Resources
? Job Descriptions
? Recruitment Information form
? Customer requirements
? Results of Corrective/Preventive Action requests
? Results of Opportunities for Improvements from Internal Audits
? Results from outside agencies’ inspections and audits
? Management or Team Leads assessed needs based on individual performance and needed skills of those within their department/team
? Request by an employee to further their career within the company
? Regulatory training and proficiency requirements that are identified in the F/GOP to include required certifications
? Safety and human factors training related to maintenance practices
? Recommendations from the Aviation Safety Council
? Requirements needed to maintain Regulatory Certifications
? A change in any of the above listed items
The company maintains a listing of identified competency and training requirements in the company records database which is available to supervisors at all levels. As new requirements are identified, supervisory personnel will forward them to the Training Official for addition to the listing.

Hope this helps,
Ron

 

[AndyN]

Let's go back to the definition of competency, from ISO 9000. It states competency is the "demonstrated ability to apply skills and knowledge".

When you use the list of documents these aren't - IMHO - a DEMONSTRATION of anything. A job description doesn't DEMONSTRATE anything. Inspections and audits don't DEMONSTRATE competency. Get the key word, here?

Evaluations? Is this of training? In order to understand what training is needed, you have to identify what's need by someone to demonstrate they can do the job. If you think about any job, you can relate maybe 5 - 10 things which their supervisor would say "yup, they know how to do that job". So is tis what the auditor is looking for, because training by itself, doesn't confer competency (as we know, once someone is tested for their driver's license...)

 

[Marcelo]

Competency defines what is REQUIRED for someone to do to something (base on education, training, skills and/or experience)

Job descriptions usually defines what people are expected to do, not what is required that they know for doing that.

Training is one way to fulfill competency, but not the only one (if someone is required to have formal education, not training will ever fulfill that).

Anyway, a quick suggestion:

If you have job descriptions that details activities people are expected to do, ask, for each one, what is the required competencies for those activities in terms of education, training, skills an/or experience.

 

[Big Jim]

Let's get back to what ISO 9001:2008 specifically says about competency.

6.2.1 sets the stage.

"Personnel performing work affecting conformity to product requirements shall be competent on the basis of appropriate education, training, skills and experience"

The note following illuminates the need for anyone involved, directly or indirectly, by performing any task within the quality management system, needs to be competent, not just those that most frequently handle product.

In 6.2.2 we learn that the organization needs to define those competencies.

"The organization shall . . . determine the necessary competency for personnel performing work affecting conformity to product requirements . . . "

If the OP's system has a weakness, I suspect this is where it is. The auditor may have felt that the needed competencies were not adequately defined for production and inspection personnel. He may have felt what is there was not specific enough.

Many companies don't spend adequate time defining the needed competencies and move immediately to the next part.

"The organization shall . . . where applicable, provide training or take other actions to achieve necessary competency . . . "

If you have not adequately defined the needed competencies, how can you determine the needed training or other actions to get there?

Take another hard look at how you have defined competencies. They can be stated in a somewhat general manner if you are careful on how you craft the explanation. It doesn't need to be an extensive list drilling down to the minutia, but it does need to cover what is expected of the employees. If they need to know how to read prints, say they need to read prints, then show how you determined they know how to read prints (prior experience, school, print reading training, print reading test, or whatever method you used). If they need to know how to use a machine, say so, and show how they learned (likely on-the job training). If they need to know how to inspect, say so, and then show how they gained that skill/competency. And so on. It helps to make the competencies needed somewhat general so it covers a lot of ground. If you come up with a list of 100 that's way over detailed. If you have a list of 6 that might be a bit skimpy (and might not depending on circumstances and how general you make them).

Don't forget:

"The organization shall . . . evaluate the effectiveness of the actions taken . . . "

This is truly how you determine they are competent. This might be done by follow up from the trainer a month or two after the training to see how well it stuck. It may also be done by tracking KPI (no increase in bad product).

and:

"The organization shall . . . maintain appropriate records of education, training, skills and experience."

(I know, I left out the bit about ensuring that personnel are aware of relevance of their jobs and how they contribute to the achievement of the quality objectives, but that isn't pertinent to this discussion.)

So I would suggest you look over your job descriptions (or whatever you use to define competencies needed, and it could be as simple as a skills list that might even be part of a training matrix) and see if you adequately covered the bases. If you didn't, accept the nonconformance and fix it. If you did, place a call to your certification body and appeal to them.

Whatever you end up doing, best of luck in your outcome. If nothing else, this thread should have improved your knowledge on the topic.

 

[John Broomfield]

taboothu,

In developing your organization's process-based management system you should have determined the processes necessary to ensure people whose work affects product quality have the ability to apply their skills and knowledge to fulfill requirements.

Usually this requires at least two processes:

A. Recruiting people with the necessary attributes/behaviors.
B. Training as necessary to impart and missing knowledge and skills

These processes may be owned by HR.

Of course, your organization may also choose to use its purchasing process to obtain specialized competencies.

Analyze the applicable processes and you'll see an essential input to process A is a definition of the required abilities, skills and knowledge (aka Job Description). This normally comes from the manager requesting the required competencies.

A common starting point to process B is the analysis of learning needs. Process B normally ends with a formal or informal assessment of the person's ability to do the job well when not closely supervised.

It appears that your management system is lacking evidence of these processss or controls.

The root cause to this reported nonconformity may be your depending solely on clause 6.2.2 to interpret 6.2.1 in ISO 9001 instead of referring to the normative reference ISO 9000 for the full definition of competence.

It is a common nonconformity that, understandably, many auditors ignore unless they find evidence of incompetence. Having reported this nonconformity, your auditor may have invoked corrective action to strengthen your management system or you may discover that your management system already includes these undocumented procedures and controls to deliver competence.

Whichever, your management system should provide top management with confidence that their requirements for competence will be (and are being) fulfilled.

Good luck,

John

 

[drgnrider]

taboothu,

We use a simple spreadsheet to address this. Each department has identified a few items that pertain to their department, (i.e.: Machine shop: Blue print reading, measuring equipment, CNC controller, etc.). Each employee is then graded by their manager for each of these competencies as "C" competent, "T" Training, and "N/A" not applicable.

Along with the established job descriptions and training records, we seem to have gotten auditors to buy off on the "demonstrated competencies".

 

[the47guy]

Here is the paper from the ISO 9001 Auditing Practices Group pertaining to Competence. This should give you some good info.

 

[Big Jim]

It should be pointed out that this guidance from the Auditing Practices Group is found on the TC-176 web site, and that it carries both the ISO and IAF seals.

TC-176 is the technical committee within ISO that is responsible for developing and managing ISO 9001.

Although there is a disclaimer that none of the Auditing Practices Group publications posted there have been vetted by ISO, TC-176, and the IAF, it should be seriously considered as guidance on the topic.

Thanks for posting the link.

 

[AndyN]

It should be pointed out that this guidance from the Auditing Practices Group is found on the TC-176 web site, and that it carries both the ISO and IAF seals.

TC-176 is the technical committee within ISO that is responsible for developing and managing ISO 9001.

Although there is a disclaimer that none of the Auditing Practices Group publications posted there have been vetted by ISO, TC-176, and the IAF, it should be seriously considered as guidance on the topic.

Thanks for posting the link.

Pity it's NOT in ISO 9004...