Here is a problem that I know will come up in my visit by our registar....
In the past either myself or the Quality Control Manager has performed a internal audit on our QMS. The last visit from our registar, he raised a minor issue with the fact that my QC manager and myself are too close to the QMS. We have a third internal auditor but with recent event she has not had time to perform any audits. The audit on QMS is 38 days past due with no relief in sight for my third auditor. My question is this.. would it not be better to have some form of audit done by someone "close" to the QMS as opposed to no audit at all? :frust:

Here is a problem that I know will come up in my visit by our registar....
In the past either myself or the Quality Control Manager has performed a internal audit on our QMS. The last visit from our registar, he raised a minor issue with the fact that my QC manager and myself are too close to the QMS. We have a third internal auditor but with recent event she has not had time to perform any audits. The audit on QMS is 38 days past due with no relief in sight for my third auditor. My question is this.. would it not be better to have some form of audit done by someone "close" to the QMS as opposed to no audit at all? :frust:

ISO 9K2K 8.2.2 Internal Audit Last sentence of paragraph 2
"Auditors shall not audit their own work"

Can you provide more details about what PART of the QMS the minor was written for? There are many parts of a quality system. Is your QC responsible for all of it?
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Example: If the QC is responsible for Managing the Corrective Action program at your company the QC can not audit THAT PART of the quality system. Someone else will have to audit that PART of the system.

If the QC is responsible for ALL quality activity management and personally does all the work, well you're going to have to find someone else to audit the QC's task. This obviously is difficult in a small company!
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As far as the 3rd person not having TIME, it is up to Executive management and the Quality department to ensure that the system is Maintained and audited at DIFINED intervals. Try working out a better time. The boss may have to step in to ensure audits are done.
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I hope this helps.
This is just my $0.02, I'm sure you'll get better responses soon. :D

ISO 9K2K 8.2.2 Internal Audit Last sentence of paragraph 2
"Auditors shall not audit their own work"

Can you provide more details about what PART of the QMS the minor was written for? There are many parts of a quality system. Is your QC responsible for all of it?
------------------
Example: If the QC is responsible for Managing the Corrective Action program at your company the QC can not audit THAT PART of the quality system. Someone else will have to audit that PART of the system.

If the QC is responsible for ALL quality activity management and personally does all the work, well you're going to have to find someone else to audit the QC's task. This obviously is difficult in a small company!
------------------
As far as the 3rd person not having TIME, it is up to Executive management and the Quality department to ensure that the system is Maintained and audited at DIFINED intervals. Try working out a better time. The boss may have to step in to ensure audits are done.
------------------
I hope this helps.
This is just my $0.02, I'm sure you'll get better responses soon. :D

The QC manager and I try to keep away from areas where we feel there will be a problem with us auditing our own work, but we did want to "hit" the areas such as internal communication, training, work enviroment, infrastructure, things where our job duties would not interfere or cloud a audit. For me, the compliance systems manager, I upkeep the ISO program, engineering changes, and other items as they relate to approval/listings of our products in the world market.

Here is a problem that I know will come up in my visit by our registar....
In the past either myself or the Quality Control Manager has performed a internal audit on our QMS. The last visit from our registar, he raised a minor issue with the fact that my QC manager and myself are too close to the QMS. We have a third internal auditor but with recent event she has not had time to perform any audits. The audit on QMS is 38 days past due with no relief in sight for my third auditor. My question is this.. would it not be better to have some form of audit done by someone "close" to the QMS as opposed to no audit at all? :frust:

Brad,

This has been discussed in some detail recently in another thread. Unfortunatley I do not know how to add the Hyperlink here but I can spell it out.

Go to: Elsmar Cove fourms/Auditing and Registrars/Auditing then find the thread 'Can the Management Representative do internal Audits?' It has HEAPS of info on this topic.
My personal Opinion is that I leave the QMS to be audited by the Registrar. I audit all of the other stuff. Hope this helps.

Greg B :)

Good idea Greg,

The link is Can the Management Representative do internal Audits? (http://elsmar.com/Forums/showthread.php?t=5801)

All you need to do is to find the thread in question, right click it and use copy shortcut the link from there. Then you use the insert link in the message editor.

/Claes

I'm surprised it didn't get any 'similar threads' hits that most threads have at the bottom of each page.

The QC manager and I try to keep away from areas where we feel there will be a problem with us auditing our own work, but we did want to "hit" the areas such as internal communication, training, work enviroment, infrastructure, things where our job duties would not interfere or cloud a audit. For me, the compliance systems manager, I upkeep the ISO program, engineering changes, and other items as they relate to approval/listings of our products in the world market.

Brad,

You say you "try" to keep away from areas where there might be a problem. Is that where you received the "Minor"? If the minor is cited as "too close to the QMS", without a clear tie-in to the specific activity, you and the Auditor should square off and hash it out. These guys are sometimes opinionated and opinions do not get written down as a finding. I suspect you were criticized for auditing an area where you do work. Yes? :agree: :smokin:

Brad,

You say you "try" to keep away from areas where there might be a problem. Is that where you received the "Minor"? If the minor is cited as "too close to the QMS", without a clear tie-in to the specific activity, you and the Auditor should square off and hash it out. These guys are sometimes opinionated and opinions do not get written down as a finding. I suspect you were criticized for auditing an area where you do work. Yes? :agree: :smokin:

We were "written up" for having myself do an audit of the QMS. The auditor felt that since I am the lead auditor that I should distance myself from this audit. I am somewhat confused by the remarks from Greg. He had said let the registar do the audit of the QMS, but if we let that happen we will have no means of assuring that the continual improve of the QMS is taking place. Correct?

Brad,

I think you are running a real risk there. Since it has already been raised as a issue once, what will the registar say when he comes across the same thing again? & unless he is lazy he will, as clearing the corrective actions is the first thing they do.

You need to make the management aware of the situation, and get that third auditor busy.

If that is impossible, then maybe a creative situation is needed...........

But being aware of the problem, and not correcting it will look bad to an assessor IMHO

Ponder these......

Is it acceptable for an individual that is a member of an organization made up of 1 person to audit the organization?

Which is more desirable, independence or objectivity in auditing if both are unachievable?

Is the registrar auditing the QMS actually achieving what the standard requires when it specifies and audit of the QMS?

Ponder these......

Is it acceptable for an individual that is a member of an organization made up of 1 person to audit the organization?

Which is more desirable, independence or objectivity in auditing if both are unachievable?

Is the registrar auditing the QMS actually achieving what the standard requires when it specifies and audit of the QMS?

Good point...How do very small companies deal with this issue or is it even an issue for them because of their size?

Ponder these......

Is it acceptable for an individual that is a member of an organization made up of 1 person to audit the organization?

Which is more desirable, independence or objectivity in auditing if both are unachievable?

Is the registrar auditing the QMS actually achieving what the standard requires when it specifies and audit of the QMS?

Randy:

The consultants among us will love this, but in such a scenario I see only 1 "true" solution - hire an outside source to do internal audits, and another to do the cert. Expensive and inefficient.

The fact that the principal has to be versed in ISO, or QS, and at the same time conduct business makes this very difficult. In the "new economy" where one person businesses seem to be growing, y'all may have found a very profound failing of the powers that be.

Any comments from 176 on this issue? I have not seen any.

Craig

Hi,
In my own perception, why don't you performed a pre-assessment audit? and make a corrective and preventive action. In making an audit, one should be independent on the area that was been audited. I f someone that is "close" to the QMS would perform the audit, you must show to the registrar that the assigned person is "indirectly" not related to the QMS. Or you can perform "Self-Audit" , that is assessing what could be the problem on the QMS.

Hope this helps.

Best regards,
Raffy :cool:

We were "written up" for having myself do an audit of the QMS. The auditor felt that since I am the lead auditor that I should distance myself from this audit. I am somewhat confused by the remarks from Greg. He had said let the registar do the audit of the QMS, but if we let that happen we will have no means of assuring that the continual improve of the QMS is taking place. Correct?

Brad,

Sorry :o I did not mean that I leave everything up to the registrar to audit in the QMS just those parts that I have a direct involvement in. I can use the registrars observations/findings as part of the company's Continuous Improvement strategy. For Instance: I write and issue the Procedure for Document Control. I cannot audit myself but I can audit other departments for their document control. I audit the componayand the registrar audits those areas I cannot. I hope this makes sense. :bonk:

Greg B

Brad,

I cannot audit myself but I can audit other departments for their document control.

Greg B

What if you're a single person company and you don't have the resources to "hire".

It seems to me that like many other things in this line of endeavor (the ISO world) that TC-176 didn't take into account the small business guy again when they wrote 8.2.2 (this is similar to the RAB not recognizing what is really happening in the audit arena). It's funny that ISO 19011 only says that an auditor SHOULD be independent and that ISO 14001 just says that audits shall be performed. Independence is nice, but objectivity is better. I would not slam an auditee if they could prove that a non-independent auditor audited objectively.