What Compliance to ISO 9001, 6.2.2 Competence, Awareness and Training Means

[qusys]

Re: Compliance to ISO 9001:2000, 6.2.2 Competence, Awareness and Training

I would like to exand on this just a bit. Also consider non-training methods to meet the requirement for competency. If you need someone competent in welding, you could train a welder, or you could hire someone who is already competent. But if you hire them, how do you really know they are competent. I mean no one every embellishes on applications or resumes, do they? Well, just as qusys says, use the same things for hiring, or transfering, or whatever as well.

Agree with you, db.
The clause 6.2.1 also deals with education, experiences, skill and the hiring process shoould evaluate the competence of a new resource taking into consideration those items.

 

[fallon]

First off, thanks to all who’ve responded, it’s been extremely busy the last two days. I exceeded the timeframe earlier today with a rather lengthy response and after finally getting it done, was asked to log in and lost said response. Response improvement point; work in Word then copy and paste. 
After reading the responses, I thought some additional info would help explain my situation. I don’t work for the company I’m auditing. The company’s Quality Manual is pretty much a copy of the ISO 9001:2000 standard. I understand there are many ways an organization can go about evaluating competency/training of their employees. I cited 4.2.4 because, regardless of what fashion one uses to evaluate training/competencies of employees, wouldn’t one have to produce records of some sort providing objective evidence of just that?

Gusys, to answer your question in a nutshell, they didn’t evaluate any of their training on any level. Individuals are initially trained, then set to work. There are certain special process owners who test/evaluate their subordinates annually and document everything. But the bulk of the workforce has no follow-up to training they’re given and the QM said there’s nothing that requires them to have any.

Rickser, thanks for those documents. If the Quality Manager had produced such documents during the audit, we wouldn’t be having this conversation.

Andy, I get the feeling you thought I was an internal auditor for the company. Although you refer to “ISO speak”, the questions I asked during the audit were from a generic ISO Audit Checklist. “Has the organization c) Evaluated the effectiveness of the actions taken?” Ironically, the last column, which they couldn’t answer, was, “Implementation Objective Evidence”. They said they were covering all these aspects but couldn’t show how. Then it became, “we don’t have to have records for that.”

Jim, your point as to, “A simple note in the training file provides a record.” would seem to fulfill the evaluation requirement after a supervisor interviews/observes an employee. The fact that there were no OJT records at all leads to more questions regarding how training was performed, what material was used, etc. There are also multiple instances of operator error based on lack of understanding how to perform a particular task. I know that some say the product output can be an indirect form of competency/training confirmation but you’d have to incorporate in-process rework/repair into the equation for a realistic indication.

The system here is more reactive than proactive. Supervisors are more concerned with production count and assume everyone knows what they’re doing. It’s when something goes wrong that everyone scrambles to “retrain” the subject employee(s). No one ever seems to ask the question, “How did this happen to begin with?”

Mikishots and Rickser both possess processes that not only document training but verify understanding of that training with documentation that can easily be produced during an audit. That, I believe was the intent of 4.2.4. You can’t just say you are doing something, you have to show it. If 6.2.2c is a requirement of the standard and 4.2.4 states you must have records to provide evidence of conformity to requirements and of the effective operation of the quality management system and their Quality Management System mirrors 9001:2000 word for word, then I would consider them not compliant to the standard. How could I justify any other stand?

 

[qusys]

First off, thanks to all who’ve responded, it’s been extremely busy the last two days. I exceeded the timeframe earlier today with a rather lengthy response and after finally getting it done, was asked to log in and lost said response. Response improvement point; work in Word then copy and paste. 
After reading the responses, I thought some additional info would help explain my situation. I don’t work for the company I’m auditing. The company’s Quality Manual is pretty much a copy of the ISO 9001:2000 standard. I understand there are many ways an organization can go about evaluating competency/training of their employees. I cited 4.2.4 because, regardless of what fashion one uses to evaluate training/competencies of employees, wouldn’t one have to produce records of some sort providing objective evidence of just that?

Gusys, to answer your question in a nutshell, they didn’t evaluate any of their training on any level. Individuals are initially trained, then set to work. There are certain special process owners who test/evaluate their subordinates annually and document everything. But the bulk of the workforce has no follow-up to training they’re given and the QM said there’s nothing that requires them to have any.

Rickser, thanks for those documents. If the Quality Manager had produced such documents during the audit, we wouldn’t be having this conversation.

Andy, I get the feeling you thought I was an internal auditor for the company. Although you refer to “ISO speak”, the questions I asked during the audit were from a generic ISO Audit Checklist. “Has the organization c) Evaluated the effectiveness of the actions taken?” Ironically, the last column, which they couldn’t answer, was, “Implementation Objective Evidence”. They said they were covering all these aspects but couldn’t show how. Then it became, “we don’t have to have records for that.”

Jim, your point as to, “A simple note in the training file provides a record.” would seem to fulfill the evaluation requirement after a supervisor interviews/observes an employee. The fact that there were no OJT records at all leads to more questions regarding how training was performed, what material was used, etc. There are also multiple instances of operator error based on lack of understanding how to perform a particular task. I know that some say the product output can be an indirect form of competency/training confirmation but you’d have to incorporate in-process rework/repair into the equation for a realistic indication.

The system here is more reactive than proactive. Supervisors are more concerned with production count and assume everyone knows what they’re doing. It’s when something goes wrong that everyone scrambles to “retrain” the subject employee(s). No one ever seems to ask the question, “How did this happen to begin with?”

Mikishots and Rickser both possess processes that not only document training but verify understanding of that training with documentation that can easily be produced during an audit. That, I believe was the intent of 4.2.4. You can’t just say you are doing something, you have to show it. If 6.2.2c is a requirement of the standard and 4.2.4 states you must have records to provide evidence of conformity to requirements and of the effective operation of the quality management system and their Quality Management System mirrors 9001:2000 word for word, then I would consider them not compliant to the standard. How could I justify any other stand?

Hi Fallon,
appreciated your thanks!
A question for you: is this a second party audit vs a supplier of yours?
If it is the case, what were the objectives and the criteria of this audit?
I am assuing that the organization is ISO 9001 certified an so they could say this to you, if you are writing a non conformity for this.
In any case , I agree with you. Based upon you wrote and telling us the dynamics of the assessment, this is a non conformity, given that the clause is partially met.
I would kindly know if they identified Training or Human Resource Management as one of their QMS processes.
To go furtherly into deep, you would have asked for KPI and metrics of this processes, in order to understand if it is effective.
If not, you could have another evidence that there is a shortfall in this process/activity.
Always based upon you said, there are some lacking in the recording training and on the job training.
It seems very strange that they did not show any procedure or policy training, even though the standard does not mandate it. ISO TS asks for it and probably this could be also an improvement for ISO 9001.

 

[Rickser]

Fallon, I think, IMO, that you have have a potential NC at this point. You may can turn it into a true NC if you have evidence of: "There are also multiple instances of operator error based on lack of understanding how to perform a particular task." That is what it would take to write the NC.

 

[AndyN]

Fallon: what is you role in auditing the company? Asking questions from a generic audit checklist IS ISO SPEAK isn't it?

 

[Mikishots]

This might be a touch off-topic, but may be interesting to note; I work for an aerospace company, and our QMS is certified to the AS9100 standard (Sec. 6.2.2 is identical to ISO 9001:2008's Sec. 6.2.2). Also included in our scope are the Canadian Aviation Regulations (CARs), one of which being Standard 561. In 561.11, the training program that is required to be established and maintained is as follows:

a). initial training to ensure that all persons authorized to perform or supervise the performance of functions under the Subpart are aware of their technical, administrative and regulatory responsibilities;
b). update training to ensure that these persons remain competent and are made aware of any change to their area of responsibility;
c). additional training, where shown to be necessary by a finding made under the QAP or required due to changes in the CARs, Standard 561 or company procedures...

The TCCA has noted that the AS9100 doesn't go far enough and wanted to make sure that the requirements were explicitly stated.

Where the company you've audited falls down is in evaluating the effectiveness of the actions taken. If they provided initial training and that's all, ask them how they evaluated the effectivity of that training, and how do they determine if more training is needed? Remember, to measure, they must have a target. This is where metrics come in.

 

[JaneB]

...they didn’t evaluate any of their training on any level. Individuals are initially trained, then set to work. There are certain special process owners who test/evaluate their subordinates annually and document everything. But the bulk of the workforce has no follow-up to training they’re given and the QM said there’s nothing that requires them to have any.

I suggest we should be talking competency and not just 'training'. That's what the clause refers to - training is one way of achieving competency.

Whether training is given or not isn't the main issue, surely: competency is. So if they're simply providing some training and setting 'em to work, their system is lacking, because they haven't assured competency, they haven't evaluated the effectiveness of said training, and they don't have any records to demonstrate their personnel are competent. If they didn't have the records, but there was plenty of evidence of competency of personnel (eg, lack of errors), then it would be less of an issue of competency, and more one simply of managing records.

... Rickser, thanks for those documents. If the Quality Manager had produced such documents during the audit, we wouldn’t be having this conversation.

Perhaps. But presumably you'd still want to see the records
NB: that kind of documentation would require a company of a certain size to be able to create and maintain.

The fact that there were no OJT records at all leads to more questions regarding how training was performed, what material was used, etc. There are also multiple instances of operator error based on lack of understanding how to perform a particular task.

Errors sound like evidence of lack of competency . Root cause may well be lack of training or inadequate training.

 

[somashekar]

Hii Fallon...

The system here is more reactive than proactive. Supervisors are more concerned with production count and assume everyone knows what they’re doing. It’s when something goes wrong that everyone scrambles to “retrain” the subject employee(s). No one ever seems to ask the question, “How did this happen to begin with?”

Not a unfamiliar situation in a production shop ...
The intent of the standard is to ensure that the right people get to do the right task such that the right outputs happen.
Its people everywhere ..who do, who get things done, who manage, who boss, who own ....
Just let the people who get things done map the levels of competency of the people who do.
Create such a matrix that maps skills necessary and identified against people who are available to do that in terms of Not skilled (cannot perform) , semi skilled (can perform and needs supervision / correction) , skilled (can perform independently) , Skilled and can train (can perform independently and knows how and why of the necessary skills, and so can train and supervise)

Such a matrix must be dynamic and work deployment and supervision must be based on this. This complies to requirement.

 

[John Broomfield]

Hi all,
I'm looking for clarity to what compliance to 6.2.2 actually means. The standard states in 6.2.2, "The Organization shall a) determine the necessary competence for personnel performing work affecting product quality, b) provide training or take other actions to satisfy these needs, c) evaluate the effectiveness of the actions taken, ...) In performing an ISO audit to Element 6 I asked the QM how he complied with 6.2.2c. His said after initial training, which is documented on an internal training form, no other evaluations are needed. I mentioned in 4.2.4 where it states, "Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. Records shall remain legible, readily identifiable and retrievable." My question is should there be records in place documenting some form of evaluation that any training of operators given is a) understood by the trainees and b) being implemented properly by said trainees? Anyone run into this? Thanks for any input.

fallon,

Four ways to obtain competencies required:

1. Recruiting
2. Training (and education)
3. Subcontracting
4. Outsourcing

As for 2 focus on what your supervisors and team leaders are already doing to stop an incompetent person from working unsupervised or without a coach or mentor.

Ask them how they organize on the job training (and other necessary learning) and how they know the trainee is competent.

You may end up with a resource management matrix for each group of employees that shows the competencies required and the names of each employee. The cells of the matrix could show who is learning, who is competent and who is competent to teach.

These competency matrices are used by the company and group leaders to ensure they are developing or obtaining the competencies needed (per 1, 2, 3 and 4 above).

John

 

[fallon]

All,
Thank you for the array of informative responses. As I stated in my second post, I don’t work for this company. They are one of our suppliers. Being a second party audit, the focus was ensuring their QMS was compliant with the quality requirements (ISO 9001:2000) flowed down to them through multiple delivery orders. As their quality manual was a copy of the standard, I used the generic checklist. Their late delivery schedule coupled with multiple concession requests indicated some process/operator issues which needed to be evaluated.

Jane,
You hit the nail on the head with the competencies aspect of this evaluation/audit. It was questionable competencies which lead to this audit in the first place. Training was identified as lacking/non-existent in some cases. The existing training procedure wasn’t adhered to. They had started writing a new procedure but it was still in draft form as of the audit. Because they had no follow up to their training procedure, the question of competencies came up repeatedly in our discussions.

Somashekar/John,
What you both posted is what they should have been doing before I started this audit. I told them when I started the audit my job was not to tell them how to do their job but to validate that they were compliant to the standard. My findings indicated they weren’t.

On a positive note, the QM informed me today that they are developing a matrix which identifies competencies required in most job functions. This matrix will track initial training as well as a follow up evaluation at an interval TBD. The software program will also track outside training/certificate courses. Of course this means little if they don’t implement properly. A welcome turn of events though. It’ll be interesting to see how this plays out over the next couple of months. Thanks again for all of your insights.