I was told that the MR (Management Representative) shouldn't be doing internal audits

J

Jim Biz

#11
Ted - In a word No - in two words - no suggestins.

For sake of explaination my thoughts run this way :

Although you may be "independant of the day to day physical activities" - the way I'm reading this is that you can NOT be independant of the planning or "decisions made" for many overall system activities as the Corporate Quality manager (and I'm assuming Corporate Management Representative.)

As such you "are responsible" for ensuring processes are established and in place "implemented and maintained."

Possibly you would agree that there remains a certain amount of ISO system "work" involved with this activity??

My opinion only - If the MR makes the decision that a process is indeed needed - plans the steps and makes sure it is implemented as he/she envisioned - continues to "direct and asvise" on the use of the process - then he/she can not be removed and be "objectivley independant" of its maintainance or its operation. (however good at "directing and advising" ie delegating Tasks one might be)

8.2.2
Auditors SHALL not audit their own "work"
 
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T

Ted Black

#12
;)
Jim,
Thanks for your comments. I do agree that I am not completely independant (technically). I am trying to convince the auditor to overlook this finding for two reasons:
1. Our divsions are small (8-15 persons) and do not have the resources to develop auditors internally (at least effective ones).
2. I use internal audits to not only determine conformance but to also identify areas that conform but could be improved and to help them determine a solution and implement these changes.
I would hate to give this up because an auditor feels that I cannot be neutral.
I guess we will need to get some auditors trained to audit our internal audit program.
 

E Wall

Just Me!
Super Moderator
#13
As the Corporate Quality Manager is it your responsibility to enforce the systems that the auditor feels doesn't give you enough bias?

Since this finding has occurred a number of times how do you ever close out a Non-conformity? Or is the corrective action put in place not sustainable? You probably have asked what specifically the auditor had an issue with, and to be honest without that information I'm not sure that I could provide any other assistance.
 
G

George Opacic

#14
The impartiality of an auditor, I thought, refers to the specific area being audited and its documents (8.2.2).
"What" is being audited is, a) conformity to the Standard and the QMS; and b) that the processes and their documents have been effectively implemented and properly maintained.
Therefore, has the auditor done the implementing, specifically of that area, and/or doing the maintenance of the QMS in that area?
In those organizations that have come at a QMS from the old "siloed" Product quality philosophy of many corporations, the answer is very often, Yes. The Internal Auditor helped write the procedures at the start. If you come at it from the Organizational quality viewpoint, the answer is usually No - each person owns their procedures and their only interaction with an Internal Auditor is when that other set of eyes is asked to determine if further opportunities for improvement can be found.
YesNo?
 
J

Jim Biz

#15
Food for thought

We do what can be called "cross functional"
internal audits here but are very careful with them from the independance standpoint.

Our welding department folks - although responsible for that portion of "processing" do internal audits of the "machining processes and visa versa.

We have our outside consultant - reccommend a qualified local retired person to come in once or twice a year (when needed) and audit the parts of the system I am responsible for as Mgt Rep. (internal auditing - internal auditors etc. )

Frankly the best solution to the "independence delima" (which we have yet to arrange & implement) is to "Team up - with a locally registered company and "trade internal auditors for a day or two each year... Our guys auditing their systems ... theirs auditing our systems... That method would I would think totally eliminate the independance aspects.

As for discovery of improvements - the new standards has made continual improvement a larger issue than "improving due to audit findings --- and will allow any Mgt rep to go over any business process aspect to rrcommend improving where it needs to be done (internal audits being only a part of the information he uses to come to that conclusion.

I would be real interested if you are successful in persuading the external auditor to "overlook" a finding because of lack of resources.
 
G

George Opacic

#16
It may be a matter of local culture, but why would you approach the Registrar in a confrontational mode?

Our registrar is the 4th level of welcome review of our processes (NCs - known as Opportunities For Improvement - plus Internal Auditors, Management Review, Registrar). Each level searches for improvements that can be made to help the staff and the company.

Maybe this "nice Canuck" attitude would have trouble getting transplanted?
 
G

Greg Maggard

#17
Show your MRs this p.56 in the QS9000 Quality Requirements book 4.17 second paragraph. But there is a difference in that and just an observation. Hope this helps you a little:bigwave:
You must get the team behind you. The plant manager is the Captain of the ship. He will go down with the Car in hand. hehe
4.1.1.2 f Managements responsibilities and 4.1.2.2 Resources:ca:
 
E

energy

#18
Example of what we are up against!

This is an excerpt of an Internal Auditor's findings in regards to accessing electronic and hard copies of released procedures:
50% (5 out of 10) of the employees audited were unaware of how to find the latest document

This in spite of written instructions detailing "exactly" how to do it. Realize that 80% of the people have computers and are not novices. Some have suggested that it is a training issue.:bonk:
I say it is a "I could care less" issue. The document acknowledgement sheet that states that "I have read and understand" the procedure and " will refer to this document on a regular basis" was signed by all.

The fact is, they signed it and returned it without a thought. It's a nuisance and has nothing to do with them. Oh, we'll issue CAR's and they will cite lack of training as the reason, dumping it right back on me. This is a pure case of not buying in to the system.

If you have to conduct training sessions for complicated procedures, we do for detailed OSHA mandated procedures, I can see that. This is not a training issue. This is an "ISO is for you, not me" issue. The names are quite revealing. Knowing all the personnel, I could have predicted who would pass and those who wouldn't. The personalities and comments made about the ISO effort from these morons have all been negative. 50% of the 50% who couldn't locate the procedures are supervisors/managers. No help there.
So, we will audit them again and write more CAR's and keep on trucking. What me worry?:ko: :smokin:
 
J

JodiB

#19
Pass the buck

Energy,

Make the training the responsibility of each manager. I call them Responsible Managers in my procedures. That way the onus is on them to see that training is effective. In fact, if you outline that the RM's "shall ensure", then the CAR is actually on them! woo hoo
 
A

Aaron Lupo

#20
Depending on how large the company you work for is that may work. I work for a small (~130 people) privately held company and the Managers can do no wrong. I am sure in a larger company "passing the buck" would work.


Anyone out there looking for someone with FDA/MDD/ISO/EN experience??:biglaugh:
 
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