Corrective action following a wrong answer of the auditee

[Libnani]

I was faced with a problem during doing my last internal audit :

during my audit i remark the presence of non qualified driver doing handling of the final product in the production area (his name doesn't exist in the list of qualified people for the manutention )
I asked the production chief about the criteria or the competence on which
is based the qulaification of such drivers .
he answered me that there is no such criteria or any matrix of competences
for such job .

So I issue a non - conformance related to paragraph 7.5.5 of ISO 9001 (preservation of the product) : risk of deterioration to the product

the production chief proposed as corrective action that he established a list of criterias (or competences) which should respect any person before starting his job as driver in the production area .

I agree with this proposal and i fix a date of verifiation a month after .

I sent my audit report to the quality manager who approved it and send
it to the concerned people .

2 weeks after this , the production chief sent me the list of criterias (competence) which he had established and the training sheet of the driver following the audit , and asked me to close the non-conformance .

but when i was filing this list , i was shocked to find that there was a list of criteria for drivers andwhich was established by the same chief production 2 years ago !


My question :
who is reponsible of such failure in the system ?
the auditee : the production chief who gave me a wrong answer
the auditor : me
the quality manager : who is reponsible of managing the list of criterias
for all the staff of the company and he approved
my audit ?

what should be the quality manager corrective action following this failure ?

N.B it's a bit complicated don't hesitate to ask me for any clarification.

 

[atitheya]

During the audit, the auditor should have verified with the Quality Manager / MR vide procedure on Control of Documents wether a document for competencies exists or not and then looked for the driver's competency. Determining the competence is a requirement under 6.2.2 ISO 9001:2000 and most organisations document these also (depends how they want to communicate these competencies to concerned persons). In fact the production chief's answer shows a non-compliance of clause 6.2.2 (a) and should have been reported.

The Quality Manager obviously thought you have verified all facts before raising the non-compliance and believing this he approved of the report.

 

[Libnani]

Dear

From my experience , the auditor should verify the "yes' of the auditee
but not the "No"

It's practible to ask the auditee for example is there any procedure
for the treatment of corrective actions ? and if the auditee says "yes"
then the auditor could ask him to show the procedure .

but if the anwer is "NO" it's not practible to ask the auditee to show me all his procedures and search for such procedure or maybe paragraph in the procedure to detect that his "NO" is wrong .

No , i can't see that this was the responsibility of the auditor !

 

[Jen Kirley]

I agree with Atitheya.

Yes, the auditor should do the research needed to understand the nature of the problem so as to assign and accept the appropriate corrective action. That means researching specifications and other documents to understand what guidance is available, how easy it is to access, if it's current and how clear it is.

If the auditee doesn't know about his own training plan, then produces the thing from two years ago, we have issues beyond product deterioration or even the plan's existence. The training plan should not be the sole responsibility of this fellow. How does the system make sure people's training is kept up to date and that only qualified people are working with product? In a process audit such following questions are proper.

 

[Libnani]

Beacuse of this , the quality manager which manages the training plans
had to inform the auditor while he'd received his report about the existence of such plans before approving it .

I insist on the idea that internal auditor (which has another job inside the company) could not be aware of all existing system or process.
it's the role of the quality manager And/or concerned process responsible.

 

[Randy]

I insist on the idea that internal auditor (which has another job inside the company) could not be aware of all existing system or process.
it's the role of the quality manager And/or concerned process responsible.

Where or how did you come by or develop that theory?

Could you please difine what a process is because I am curious?

 

[Libnani]

it's not a theory , it's a fact .

Please explain me what do you find as strange : saying that the auditor could not be aware of all existing system or process. ?!:

 

[D.Scott]

Beacuse of this , the quality manager which manages the training plans
had to inform the auditor while he'd received his report about the existence of such plans before approving it .

I insist on the idea that internal auditor (which has another job inside the company) could not be aware of all existing system or process.
it's the role of the quality manager And/or concerned process responsible.

There is a strong possibility that I don't fully understand what you are actually saying here but I will offer my opinion anyway.

I have to agree with you that if you are told in an audit by the auditee that there is no procedure/list then the assumption must be that one does not exist. There should be no need to hunt for a "phantom" document.

I am not sure I understand why you would write a N/C on Preservation of Product (7.5.5) because a driver (material handler? fork lift driver? truck driver?) was not on a list. Was there something you saw that gave you the impression that the preservation of the product was compromised?

Is there a company requirement/procedure calling for such a list? Why would you need to define a criteria or competence level for drivers unless their job related to quality? Even if it did, wouldn't the job description of the driver include the criteria for obtaining the job in the first place? Are there no training records for the drivers? Is there no license requirement for driving the fork lift or whatever they are driving?

ISO 9001:2000 requires the company determines the necessary competence for personnel performing work affecting product quality. Have they done so in the job description and hiring of the driver? If so, why do they need a matrix/list?

I'm not saying you are wrong in this scenario but I fail to see the "Shall".

Dave

 

[Helmut Jilling]

I was faced with a problem during doing my last internal audit :

during my audit i remark the presence of non qualified driver doing handling of the final product in the production area (his name doesn't exist in the list of qualified people for the manutention )
I asked the production chief about the criteria or the competence on which
is based the qulaification of such drivers .
he answered me that there is no such criteria or any matrix of competences
for such job .

So I issue a non - conformance related to paragraph 7.5.5 of ISO 9001 (preservation of the product) : risk of deterioration to the product

the production chief proposed as corrective action that he established a list of criterias (or competences) which should respect any person before starting his job as driver in the production area .

I agree with this proposal and i fix a date of verifiation a month after .

I sent my audit report to the quality manager who approved it and send
it to the concerned people .

2 weeks after this , the production chief sent me the list of criterias (competence) which he had established and the training sheet of the driver following the audit , and asked me to close the non-conformance .

but when i was filing this list , i was shocked to find that there was a list of criteria for drivers andwhich was established by the same chief production 2 years ago !


My question :
who is reponsible of such failure in the system ?
the auditee : the production chief who gave me a wrong answer
the auditor : me
the quality manager : who is reponsible of managing the list of criterias
for all the staff of the company and he approved
my audit ?

what should be the quality manager corrective action following this failure ?

N.B it's a bit complicated don't hesitate to ask me for any clarification.

1. I agree that a finding was justified. The driver might not know whether there are lists, or whatever. But, the manager or supervisor who made the decision to let him drive MUST know whether he is qualified, and know how to access the list, or matrix, or whatever is used as a criteria.

2. That a criteria actually exists is irrelevant. Whether a tool exists, but no one knows it, or, if it does not exist at all is essentially the same thing.

3. The primary factor is that these tools are supposed to used by the appropriate people. If they are not, or aren't even known, that would be a nonconformance.

4. I would agree the forklift driver must be included in any training program for personnel "related to quality." There are a number of things they would interface with in ISO. In fact, there are very few people I would exclude from that requirement. I believe the intent is much broader than just production personnel.

 

[SteelMaiden]

Dave, I agree with you with one exception. In a case like this where you are talking about a training matrix, or similar, and the answer is "no, we don't have one" I believe that it would be in the auditor's best interest to check with (HR?) another person to verify that the production chief correct. Too many times (in past lives) I've seen people tell me that we didn't do something just to get rid of me. They just were not committed to the process. But, that is just my based on past experience. I seldom take something at face value, especially if it means that I will write up a nonconformance. I also don't think that preservation of product was the most applicable clause as the scenario was laid out.