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
