Corrective action following a wrong answer of the auditee

[Jen Kirley]

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.

The internal auditor is tasked to verify that an existing process is functioing properly. If the auditor, regardless of where he/she normally works, does not already know what documentation exists then the auditor needs to find out.

Verification of a system includes researching the document control system to find applicable process documents. It is perhaps not always needed to locate every single applicable document from the beginning, but if the auditor gets a sense that something is amiss, then more research may be needed. How else would the auditor know if a document is not being followed?

 

[RoxaneB]

Perhaps the production chief is not committed to the management system...or perhaps he forgot or was nervous...or perhaps he lied. Is that the real issue here or is it the fact that the system was unable to demonstrate that someone on the line who was handling product was competent to be in such a position?

I fully agree that Preservation of Product was not the most suitable clause against which to assign this nonconformance. At the end of the day there were no records to demonstrate that the person was competent. A system did in fact exist but there was no evidence to support adherence to the system.

At least, that's what I'm reading...granted, I've only had half a cup of coffee...and we all know what I'm like without my coffee...

 

[Libnani]

paragraph 7.5.5 Preservation of product :

"the organization shall preserve the conformity of product during internal processing and delivery to the intended destination .
This preservation shall include identification, handling , packaging ...."

what could be a non-conformance in handling other that the existence of a non qualified driver which can destroy the product during handling it ?!

what is more bad for a company a destroyed product (expensive ) or the non application of requirements 6.2.2 concerning the setermination of necessary competence ?!

I choose the more stringent requirement and i applied my non conformance on it .

 

[D.Scott]

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.

Good point - I certainly accept that. I guess my "hang-up" was if he said there was no matrix, who cares? No matrix is required so if he says no then what's the point of pursuing it? I would rather the auditor then asked if there is no matrix, how do you track competence and training. This could lead to other documentation/records that meet the requirements. I certainly agree with you that the auditor shouldn't just close the book at that point. He should dig a bit deeper to establish if there is no matrix, then what is there.

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.

I understand where you are going with this but I disagree. Obviously you wouldn't train a driver in SPC if they never use it. The same would apply to use of measurement equipment, specific process training, inspection etc. There is nothing in the requirement stating anything about "Production Personnel". The intent of the standard couldn't be more clear. It states "personnel performing work affecting product quality".

I agree there are very few people who do not touch somehow on quality, however that doesn't mean that everything they do falls under the requirement being discussed. The intent of the requirement is to determine, provide training, evaluate the effectiveness, promote awareness and maintain records of employee competence, awareness and training relating to personnel performing work affecting product quality. Note that the requirement does not say "work that could conceivably affect quality". The standard allows the organization to make the determination as to "necessary". Unless something comes up in the audit that shows their determination was detrimental to product quality, you would be doing no more than second-guessing their judgment.

Dave

 

[Jen Kirley]

paragraph 7.5.5 Preservation of product :

"the organization shall preserve the conformity of product during internal processing and delivery to the intended destination .
This preservation shall include identification, handling , packaging ...."

what could be a non-conformance in handling other that the existence of a non qualified driver which can destroy the product during handling it ?!

what is more bad for a company a destroyed product (expensive ) or the non application of requirements 6.2.2 concerning the setermination of necessary competence ?!

I choose the more stringent requirement and i applied my non conformance on it .

Where is the ranking on requirement stringencies? Which "shall" is more critical than the other? My vote is in for the clause that pertains to cause versus effect.

Let us consider the action we expect to result from an issued nonconformance so as to avoid issuing a nonconformance to an effect rather than a cause.

Was product damaged? If so, how did that occur? The answer to that question can help the auditor decide which clause should apply.

If product was not damaged, how can 7.5.5 reasonably apply?

If prevention is a concern, 6.2.2 is meant to govern that in order to achieve 7.5.5. This is why I focused on training--especially if that uncertified person is likely to continue handling product.

At issue here is how the organization makes sure its people are properly prepared to work with product in conformance with 7.5.5. That means identifying the competencies, preparing to meet them, meeting them, evaluating how well they are met, and keeping appropriate records to show competence.

Maybe there are all sorts of these fine activities already taking place, and the only problem is this production chief not knowing his part of the competency plan. If that is the case, in my view the competency question is more directly aimed at him for not following the plan per 7.5.1 and 7.5.2.

 

[RoxaneB]

paragraph 7.5.5 Preservation of product :

"the organization shall preserve the conformity of product during internal processing and delivery to the intended destination .
This preservation shall include identification, handling , packaging ...."

what could be a non-conformance in handling other that the existence of a non qualified driver which can destroy the product during handling it ?!

what is more bad for a company a destroyed product (expensive ) or the non application of requirements 6.2.2 concerning the setermination of necessary competence ?!

I choose the more stringent requirement and i applied my non conformance on it .

In regards to the handling of the product, was the operator handling the product properly? Have there been any actual nonconformances attributed to his handling of the product? Where is your evidence to support that the handling of the product is resulting in damaged product? Did your audit dig deep enough to answer these questions?

However, you do have evidence that there is a failure to demonstrate confomance to the competency requirements. There is a matrix by the sounds of it. There are training requirements by the sounds of it. There is no evidence to support the operator's competency to these requirements.

I think that we're all in agreement that there is an issue here. However, if the actual issue is not documented properly, we can not expect the recipient to do a proper root cause analysis or develop an effective action plan.

Added after : Jennifer, you beat me by a few seconds!

 

[Brizilla]

paragraph 7.5.5 Preservation of product :

"the organization shall preserve the conformity of product during internal processing and delivery to the intended destination .
This preservation shall include identification, handling , packaging ...."

what could be a non-conformance in handling other that the existence of a non qualified driver which can destroy the product during handling it ?!


what is more bad for a company a destroyed product (expensive ) or the non application of requirements 6.2.2 concerning the setermination of necessary competence ?!

I choose the more stringent requirement and i applied my non conformance on it .

Was product destroyed during the audit? Was their past evidence of a trend in product destruction from this driver? The driver was actually only potentially non-qualified. Remember in the real world the qualifications don't preclude product damage. This is a training and document control problem.

 

[Helmut Jilling]

paragraph 7.5.5 Preservation of product :

"the organization shall preserve the conformity of product during internal processing and delivery to the intended destination .
This preservation shall include identification, handling , packaging ...."

what could be a non-conformance in handling other that the existence of a non qualified driver which can destroy the product during handling it ?!

what is more bad for a company a destroyed product (expensive ) or the non application of requirements 6.2.2 concerning the setermination of necessary competence ?!

I choose the more stringent requirement and i applied my non conformance on it .

Your point is good. However, it appears the failure root cause will actually be deeper in the system. It was not established that the operator was not competent. It was only determined that the records did not demonstrate it. That would be an audit trail to follow, to determine where the issue is.

1st. The greater issue is in the system that allowed the undocumented driver to operate. That is a system issue, and the system must be reviwed and strengthened.

2. The second and more immediate issue, is whether the driver is competent, and that must be addressed as well.

The risk is, depending on how you write it up, some managers would only provide remedial training and fix the driver (issue #2), and never deal with the systemic issue that caused it (issue #1).

Good corrective action would drive both issues to be addressed. I think that was the point of the various replies.

 

[Paul Simpson]

To try to give an answer I've gone back to the original post.

My question :
who is reponsible of such failure in the system ?

Don't get too excited about this - it is hardly a huge problem.

the auditee : the production chief who gave me a wrong answer

Certainly an auditee can make a mistake when asked about competence criteria. In the middle of an audit it is easily done.

the auditor : me

The only mistake I can identify is the clause. If a truck (?) driver isn't listed as competent that comes under 6.2.2

the quality manager : who is reponsible of managing the list of criterias
for all the staff of the company and he approved
my audit ?

Again the quality manager need not necessarily know everything happening in every area of the company's business.

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

That depends on the root cause ... certainly in the investigation the production chief is probably now more aware of his / her own systems.

 

[Libnani]

Your point is good. However, it appears the failure root cause will actually be deeper in the system. It was not established that the operator was not competent. It was only determined that the records did not demonstrate it. That would be an audit trail to follow, to determine where the issue is.

1st. The greater issue is in the system that allowed the undocumented driver to operate. That is a system issue, and the system must be reviwed and strengthened.

2. The second and more immediate issue, is whether the driver is competent, and that must be addressed as well.

The risk is, depending on how you write it up, some managers would only provide remedial training and fix the driver (issue #2), and never deal with the systemic issue that caused it (issue #1).

Good corrective action would drive both issues to be addressed. I think that was the point of the various replies.