ISO 9001:2000 Internal Audit: Someone PLEASE find me the "Shall" on "Process Audits"

J
#11
Should......

Al Rosen said:
See Iso 9004, Guidelines for performance improvements

Para. 8.2.2, Measurement and monitoring of processes.

These are shoulds though, not shalls.
I agree with Claes.
I don't see where the internal audits fail.
Our registrar had some concern about how I was planning my audits for next year, (more of a 1994 style) and recommended that I consider changing the focus to a process model bcause it is more efficient and would take less time than what I was planning.

I especially have a problem with the NC being a Major.

How many other NC's were written on your system?

James
 
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Gman2

Involved - Posts
#12
JRKH said:
These are shoulds though, not shalls.
I agree with Claes.
I don't see where the internal audits fail.
Our registrar had some concern about how I was planning my audits for next year, (more of a 1994 style) and recommended that I consider changing the focus to a process model bcause it is more efficient and would take less time than what I was planning.

I especially have a problem with the NC being a Major.

How many other NC's were written on your system?

James
8 altogether.
One note that I am not sure everyone is aware of, I just started this job a month and a half ago. The previous QM left this system a wreck! Nothing was updated and there were no internal audits performed for over a year and a half and none to the new standard. So I walked into a mess that I am trying to clean up in a hurry. So I had 8 reports to clear up. 3 Majors and 5 minors. All are done except this one, well it WAS this one :).
I just spoke with the auditor finally and got this all squared away. This is what he told me.
Exactly what I explained above he explained again.
I think Ben Sortin's post does a good job of summing it up. The auditor actually referred to 8.4 and 8.5.1 for analysis and continuous improvement.
And basically we already doing this with our management reviews and our corrective actions but he said we need to document this in a format that SHOWS we have done a actual "process audit" . He said our corrective action report was not enough. that we need a audit format that includes questions about inputs, personnel involved, material, equipment, training, and basically any other questions we need to find the root cause and that we need to come up with ideas for a solution. And those needed to be reviewed and followed up on during management reviews. He also mentioned using 8D forms for this.
Basically I still don't think there is a clause for this, especially if you are looking at this standard like it is the OLD standard. But I guess when you start looking at this standard as if there were no old standard and just reading it as if it were new and you had have no conclusions based on your experience with the old standard THIS one starts becoming more clear, or more confusing depending on how you look at it.
But I did not fight him on this for one major reason, I think it is going to be a very useful tool in helping to identify and correct major problems, it also is a tool that keeps management even more involved, and now I can tell them "well the standard SAYS we have to do it" and that just gives me more muscle to get things done. And bottom line, it's a good thing to do.
Do I like being REQUIRED to do it though is another question.
One more thing, he is asking for no formal documentation of this as of now, he feels I have a good grasp of what he is requiring now and he will view our progress at the next audit.
He closed all our findings out and now I am waiting on word from the registrar to give us our cert.
Woo hoo for me!

G.
 
R

Randy Stewart

#13
First let me say that I'm not agreeing with the auditor, but here is how I think he was looking at it.

Under 8.2.2a it says to see 7.1. Okay, the first sentence is about planning the processes, now look at the 1st part of NOTE 1 under 7.1.

It's a stretch but it would allow a loose interpretation of the following:
A QMS is made up of specified processes and therefore an audit of the QMS is an audit of the specified processes.

I don't see a shall but under 0.2 Process approach it states "This International Standard promotes the adoption of a process approach . . . "

Those are the only 2 things that I can see.
 
B

ben sortin

#14
Try on 7.5.5.1 Storage and Inventory for size (hint the quality record will contain the data neccesary to validate that your prototype process did not use obsolete material (try and sort for that). The standard says "detect." Ben's procedure (currently in draft) will say "prevent."
 
J
#15
7.5.5.1??

ben sortin said:
Try on 7.5.5.1 Storage and Inventory for size (hint the quality record will contain the data neccesary to validate that your prototype process did not use obsolete material (try and sort for that). The standard says "detect." Ben's procedure (currently in draft) will say "prevent."
Sorry Ben, but unless I missed something Gman is dealing with 9K2K and there is no 7.5.5.1.

James
 
J
#16
Best to work with-em

Gman,
Well considering what you walked into I'd say it could have been a lot worse. It sounds like your auditor is more interested in finding out what you know. By that I mean your understanding of the requirements. Went through the same thing here. Once they are satisfied that you know what you are talking about and really do want to get things squared away properly they sort of back off and work with you. (at least ours does)

From an auditors view, with three majors found, I would have to take a hard look at the internal audit program too. This program (or lack of) is obviously not effective, and that would be the crux of it. I might have taken a little different tack, but something would have to be done and quick to get it staightened out or the next audit would be another nightmare.

We are newly initiated to certification ourselves, and am finding that, at least in our case, the auditors are trying to be reasonable and work with us. Doesn't mean we haven't bumped heads now and then, but overall it's a good growth experience.

And by the way I agree 100% about the extra ammo that certification gives you. I've been able to get things done here because of the standard that would not havehappened without that "Outside Influence".

Congrats on getting it pushed through.

James :bigwave:
 

gpainter

Quite Involved in Discussions
#17
Please note that NOTES are not auditable and are for guidance. If the note is added to your system then it becomes auditable. The auditor may be looking at the second paragraph,first sentence. To write a major or anything is pushing it MO. Request a ruling from the registrars review board. Your plan is your schedule, could you post the schedule s/he looked at? This may help a bit.
 

bpritts

Involved - Posts
#18
Speculating a bit, it sure sounds to me like the auditor (despite being in
an ISO9000:2000 audit) thinks s/he is doing a TS16949 audit. Or
at least, the auditor went to a TS16949 class and listened to the IAOB's
latest approach to process auditing

There has been a lot of discussion both here and in the world at large about
the process concept in TS16949 circles. Some of it seems to be a superficial
understanding of the process concept. For example, a TS16949 seminar I attended last

week got into a long debate about "processes" replacing "procedures". Well,
I always thought that a "procedure" was a written definition of a "process".
Many participants, though, seemed to consider them to be night and day
different -- i.e. a procedure is not a process nor vice versa.

One nice thing about being in the automotive industry -- nothing succeeds
like excess.

Brad
 

RoxaneB

Super Moderator
Super Moderator
#19
bpritts said:
Speculating a bit, it sure sounds to me like the auditor (despite being in an ISO9000:2000 audit) thinks s/he is doing a TS16949 audit. Or at least, the auditor went to a TS16949 class and listened to the IAOB's latest approach to process auditing.
I think that has becoming a running comment for many people. Our External Auditor has tried to repeatately give us a finding based upon TS16949 during an ISO 9001 audit. When we ask for the 'shall', she backs off.

Several of her Opportunities for Improvement are based upon TS16949, though. I point that out when reporting to Management on the audit results and clarifying any findings for them. If we have the time, the resources, and deem the OFI feasible and practical, we will accept it, otherwise, it's promptly rejected.

But my feeling is that many External Auditors are accredited to audit both ISO and TS, but sometimes, as happened in "Ghostbusters", they cross the streams and that's when inappropriate findings are issued, auditees complain, and auditors get defensive.
 
#20
RCBeyette said:
But my feeling is that many External Auditors are accredited to audit both ISO and TS, but sometimes, as happened in "Ghostbusters", they cross the streams and that's when inappropriate findings are issued, auditees complain, and auditors get defensive.
That would seem to be it, but if auditors just took the time to tag each finding to the proper clause in the proper standard I really don't see why this should be happening at all ??? Or am I missing something?

/Claes
 
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