Our QS9000 audit team has been using checklists to perform internal audits

B

Becky Blosser

#1
Our QS9000 audit team has been using checklists to perform internal audits. Admittedly, it is difficult to get an adequate, understandable checklist. The auditors must "translate" any checklist we use into terms our employees can understand and relate to our procedures.

Our management rep (a registered lead auditor) has been with the company for 6 months. She wants to stop using any kind of checklist and audit directly from the procedures.

Is this a good idea? Personally, I feel a little uneasy about it and am afraid we will lose members of the audit team (I have expressed this to the management rep). Does anyone have any ideas/suggestions?
 
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barb butrym

Quite Involved in Discussions
#2
I agree with the mgt rep.. canned BS lists are useless.....but a happy medium is a format that allows for the "marked up" procedure along with an audit trail and a check list that ensures that you have addressed all the issues when you are done. The check list is a memory jogger, not a list of questions to ask as written. the auditors need to think on thier feet, if you will...not just walk in with genegric questions...once a question has been asked, and fixed...what value does it have to keep asking it?
 

barb butrym

Quite Involved in Discussions
#3
forgot the suggestion part.....
have the auditors develop meaningful questions..if put to them properly, they will embrace the project...if they don't them they didn't really want to audit anyway
 

barb butrym

Quite Involved in Discussions
#4
forgot the suggestion part.....
have the auditors develop meaningful questions..if put to them properly, they will embrace the project...if they don't then they didn't really want to audit anyway
 

Kevin Mader

One of THE Original Covers!
Staff member
Admin
#5
Becky,

I agree with Barb, have the auditors develop their own working papers. Remember that you are accountable for ALL items, ISO Standard items or your own organization's, that you choose to formalize in you Quality Program. Generic working papers (checklists) will not touch on those subtleties within your Quality Program and are, in my opinion, only suitable for performing a desk study of the QP (suitability audit to ensure that the Standard items are present in the program).

Regards,

Kevin
 
B

Becky Blosser

#6
Thanks for the backup. I agree that the canned checklists are not versatile enough to meet most needs. Our audit team has been trying to get the Management Rep to sit down with us and come up with our own questions which would blend the standard with our procedures. We feel that a checklist is a good idea from the point of view of keeping us from going off on a non-productive tangent. However, she wants to avoid using ANY checklist at all, which I feel is not a great idea.
 

Kevin Mader

One of THE Original Covers!
Staff member
Admin
#7
Checklists have their advantages to. They create continuity from audit to audit, which that to has both up and down sides (they may become obsolete).
 
C

ckenn

#8
Right now we are using the checklists straight from the QSA for the first round of internal audits with 3rd edition in place. The exception are follow up audits that need the verification of effectiveness of any new level two or three documentation that have been put into place. Does this sound acceptable?
 

Kevin Mader

One of THE Original Covers!
Staff member
Admin
#9
It sounds pretty good to me. Just be careful of items that may be present in your level 1 document. You may have some hidden items, especially in your Quality Policy. The QP is often over-embelished containing several key words or phrases that, in reality, should probably not be there.

Regards,

Kevin

Back to the group...
 
J

John C

#10
Becky,
I'm pleased to see your management rep standing her ground on this and I suggest you say you are going to ditch the checklists but would like to know her reasons - not to question them, but to learn.
I wouldn't do an ISO 9000 audit on the line and I'm auditing against these requirements since before anyone heard of ISO 9000. The place for ISO 9000 compliance audit is off-line, evaluating the documentation, and this is not a job for someone learning auditing.
So forget ISO 9000. It's not the issue.
The job, on line, is to evaluate compliance with the document. So it becomes a case of asking questions to find out what the auditee knows of the task v the document, do they have access to the document and observing what they do v the document - just three things to remember; Knowledge?, document?, action?
Give them some training in other things to look out for, such as checking training records, housekeeping, defective material, material from previous job, calibration, maintenance, etc. They could write this simple list on their paperwork or on the back of their hand, or make a mnemonic; THEM; Training, Housekeeping, Equipment, Material.
Barb's idea of taking a copy of the procedure is great. I've often done it on product safety audits but never, up to now, on a quality system audit; Then you would need nothing else; no checklist, no standard, no audit trail, nothing. Just write up your mnemonics and go out and write on the procedure your observations and audit trail. Pull off the obs for the report and file the procedure as the audit trail - best solution of all if the procedure is only a few pages or you can select the few you need.
The main thing is to explain to the auditors that they just have to test the requirements of the procedure, write down what they hear and see, do a quick check of their mnemonic list and note down what they see, and then move on. That is all you want. They've no need to worry about doing anything clever. They have enough to do, doing the simple thing well.
Then, as confidence grows, you can direct them to be more incisive - but I can't help with that since I never found the need to progress beyond stage 1.
What is the audit for?
Look at 4.17. Where does it say 'audit against ISO 900x? Nowhere! It says 'verify whether activities comply with planned arrangements' and 'determine effectiveness'.
The observations show whether you have compliance. Effectiveness can only be evaluated by reviewing and analysing results, eg; yield against expectations, yield against previous figures, significance of data collected, etc. Once again, this is not an area for auditors to learn auditing. You need a team with a pretty good experience/skill set for that. And that's not a checklist business either.
We do have a checklist. I opened it at random and found a question dealing with 4.1.2.1a) and it says; "Do you have a procedure which identifies persons responsible to initiate action to prevent the occurance of any nonconformities relating to the product, process and quality system?'
It goes on like that through 4.1.2.1 b, c, d, e, and then on to 4.1.2.2, 4.1.2.3, 4.1.3 and then into 4.2. Can you believe it? I'm not suggesting that your checklists are like that, but that's the principle, isn't it?'
People are not all stupid. Most people will have a pretty poor impression of an auditor who parrots out reams of questions like that - and also a poor impression of the system that drives it, and the 'Quality Pro-fessionals' that implement it and compiled it.
rgds, John C
 
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