Help with an Internal Audit for ISO9001:2000

D

Darren Durney

#1
I wrote a new Quality Manual for the company I work for and during my BSI audit we gained a non-conformance for no internal audits being done this was due to my predecessor who obviously did not do any. Now I have wrote an internal audit form up, the question I have is though as nobody understands or is clearly interested in quality unless there is a problem how do I conduct this audit as it asks specific questions in relation to the system.

Can you help me out a bit I have added my document for you to look at just incase I have maybe overdone it a bit.

It has left me a bit confused as I dont want to add things in that people dont understand.
 

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howste

Thaumaturge
Super Moderator
#2
I wrote a new Quality Manual for the company I work for and during my BSI audit we gained a non-conformance for no internal audits being done this was due to my predecessor who obviously did not do any.
Sounds like a major nonconformity.
Now I have wrote an internal audit form up, the question I have is though as nobody understands or is clearly interested in quality unless there is a problem how do I conduct this audit as it asks specific questions in relation to the system.
In keeping with Steven Covey's advice to "seek first to understand" before diagnosing, I'm going to ask a bunch of nosy questions first.

What is top management's level of commitment to the system and internal audits? If there was some level of commitment, how could they not have noticed that their eyes and ears (internal audits) were missing? Have you or others in your organization had internal auditor training?
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#3
No internal audits being done...ouch, this is a big problem. You'd need to start from the beginning, unless you have a nonconformance tracking system in place without audits finding nonconformances. What do you have in place already?

I'm an experienced internal auditor for QMS/EMS/OSHAS and I would have trouble using your form.

Howste raised good questions. What preparation do your auditors have for this function, including yourself?

I've attached the template I use to make my checklist and take notes with. I also make turtke diagrams and flow charts, especially when there isn't a process document for the process I'm auditing. It is designed for TS, but wouldn't look different for ISO.

I hope this helps.
 

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D

Darren Durney

#4
Ok Ill start with Howste.

Yes I am a qualified internal auditor there are no other people in quality here only myself, I am the quality/health and safety manager.

managements commitment is zilch zero nothing, they dont want to know unless there is a problem , no backup no support (sorry about the ranting) all quality is apparently my problem not anyone elses and i am the one tasked to make sure this is in A1 condition before it goes out. (am i knackered yep i am)

They did not notice because they dont want to know as already mentioned and also the previous quality guy here was very good at covering things up they did not even know what was in last years audit report. (Actually i had to ring BSI myself to get a copy of it as nobody could find it when i joined)

Jennifer ok maybe most of my answers above will fill in the blanks for you, I am a qualified Quality manager MSc degree and internal auditor trained also. I have a non-conformance spreadsheet that is set up tyo track all non-conformances but what I dont have is any info prior to me starting here the previous deviant wiped the majority of info off the system.( to cover his tracks i presume). Anyway no previous audits done. I smoothed over the BSI Auditor as I know how to get around these things and this only went down as an advisory non conformance as i was not here from the last audit which was generally nice of him to do. But i have to get it done this time. I wrote the audit form for my last company which was used with comparitive ease as management were up on quality and wanted to be involved so it does and can run very simple.

Now the problem i have here is I am having to write everything from scratch from the beginning there was no manual no process no flow charts no maps no work instructions on top of this i have other things to do like ISIR, PPAP, First offs last offs general quality issues and the whole of the health and safety side to consider as i also have to look after that which i ahve also wrote a manual for.

sorry for being a bit long winded but i couldnt cut it down to shorter sentences lol
 

Doug Tropf

Quite Involved in Discussions
#5
A few more questions:

Was the BSI audit a preassessment audit?

Do you have an internal audit procedure?

Are the results of audits covered during Management Review?
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#6
I smoothed over the BSI Auditor as I know how to get around these things and this only went down as an advisory non conformance as i was not here from the last audit which was generally nice of him to do.
Be careful because you are disclosing a lot of dirt in a public forum. And, no, it was not nice for your auditor to report this as an "advisory non-conformance", because such designation is baloney. Your auditor just helped the continuation of an obvious façade certificate. While your organization might "enjoy" not being written up for a glaring major failure, this situation just adds to the problem, which is: lack of credibility in management system certificates. And that affects the people who are trying to keep the integrity of the process. This is not a victimless wrongdoing.
 

Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#7
The real point here is that Internal Audits were not done. I agree, this should have been a Major Nonconformance. The Auditor was wrong in their "soft-grading," in my opinion.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#8
Jennifer ok maybe most of my answers above will fill in the blanks for you, I am a qualified Quality manager MSc degree and internal auditor trained also. I have a non-conformance spreadsheet that is set up tyo track all non-conformances but what I dont have is any info prior to me starting here the previous deviant wiped the majority of info off the system.( to cover his tracks i presume). Anyway no previous audits done. I smoothed over the BSI Auditor as I know how to get around these things and this only went down as an advisory non conformance as i was not here from the last audit which was generally nice of him to do. But i have to get it done this time. I wrote the audit form for my last company which was used with comparitive ease as management were up on quality and wanted to be involved so it does and can run very simple.

Now the problem i have here is I am having to write everything from scratch from the beginning there was no manual no process no flow charts no maps no work instructions on top of this i have other things to do like ISIR, PPAP, First offs last offs general quality issues and the whole of the health and safety side to consider as i also have to look after that which i ahve also wrote a manual for.
Hmmm, no e-records were backed up, or did he delete them too? What about management reviews showing audit results? Were no audits done, or are no records of the audits available? These are vastly different issues. What makes it clear to you?

I just have a measely Bachelors and 18 years of QA experience, so unfortunately I still think your paperwork looks complicated if I were to use it. And, based on the plate load you have, I would think you'd want it to be simpler so others could help out. If the thing looks complicated, why should people care about it when it's not their primary job?

As Sidney said, this was a major failure and your registrar did you no favors in assigning an "advisory" nonconformance (I agree, that's nonsense) when having a major may have helped you get resources from management to resolve this. Now you are dealing with the same need, only not having it recognized as the serious issue it is.

What makes you feel as though people are only interested in quality if there is a problem?
 
C

confused1

#9
A few more questions:

Was the BSI audit a preassessment audit?

Do you have an internal audit procedure?

Are the results of audits covered during Management Review?
Another question -do you have corrective/preventive action procedures?

About management buy in -sounds like you are in the same boat I am. Seems they just want to get the product out the door.

I am reminded of an exercise we went through on the 1st day of an IRCA approved Auditor /Lead Auditor class (1994 standard ). We went over the elements and listed them - proactive vs. reactive. Same could be done for the 2000 std. ISO is about errors- reducing or preventing them and that's a big reason controlled conditions are warrented/stressed.
Errors happen, lets find out what caused them so we can keep them from happening again (at least from happening repeatedly).
But this is probably nothing new for you.
If management can see how quality can reduce or eliminate the number of repeated errors - you may find a receptive audience.

I have not had much luck, even though there have been lots of returns (tracked by mgt) they don't change processes. Seems to me to be a numbers game.:rolleyes:

Hope this helps.
 

howste

Thaumaturge
Super Moderator
#10
In my opinion, before you even start to think about the internal audit process, the first thing that needs to happen is management (leadership???) training on ISO 9001 and the principles that it's based on. I'm not joking. Until you have commitment from top management, you'll be spinning your wheels trying to get the system up and running.

It may not seem like it now, but your predecessor may have actually done you a favor by deleting a bunch of stuff. Now you have the opportunity to start with a clean slate and redefine a system that can help the company achieve its objectives.
 
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