HI there,

During our internal audit, the auditor found that the procedure has got nothing to do with what is actually being done. In another word, the procedure is there, but the content is totally invalid. Do you see that as an OFI or NC? Please advice. Thank you.

With the little information you provided, I would guess a NC. The PROCESSES are supposed to be deployed and implemented. The procedure is supposed to describe the process so the doers can effect it. If the procedure is not being followed and the document describe how the process is supposed to operate, it is a clear NC.

Unless I have missed something, you have a written procedure that has nothing to do with what is actually being done. Yes, I would call that a NON-CONFORMANCE and an OPPORTUNITY FOR IMPROVEMENT. If I were an auditor at your site it would also be a red flag to look for more of the same.

Think about these: Are people just not following the procedure or does it really have nothing to do with the process? Why was it written? Has the process changed and not the procedure? Is it out of date? There are endless questions you could ask.

Look at the process. Write a valid procedure. Make sure the current "PROCEDURE" is replaced with something meaningful and useful. Do something worthwhile.

HI there,

During our internal audit, the auditor found that the procedure has got nothing to do with what is actually being done. In another word, the procedure is there, but the content is totally invalid. Do you see that as an OFI or NC? Please advice. Thank you.

Clearly a Non-conformance, however, I have something to add, rather than simply dealing with the symptom.

Was this finding a complete surprise to the internal auditor? Did they have any idea about what the person/department/process does and did they actually read the procedure before they got to do the audit??

If the answer to either of these is 'no' then you've also got a problem with the audit process or the auditor's preparation etc.

In ISO 19011, part 2 (I think) it offers that if the documentation on which the audit is based (aka audit criteria, like a procedure) is insufficient to describe the activities, then don't do the audit. Simply put, there's no point in waiting until you do the audit to tell management that their documentation is off base.....

ok, let me clarify a little better. actually the procedure is extracted from previous QMS (also TS16949). There was a management takeover and the way they do things is different now. I keep on telling the auditor it is a NC reason being the process is not being documented. But the auditor and also the auditee defer to what i said (maybe just because they both have been in the company for a very long time and I'm new). I really hate it when this happens. The auditor keeps on telling things that does not make sense. He said the TS16949 is just a guideline and we dont have to write every procedure in the book. huh!! hey, you have a procedure, and yet, it does not reflect on what you are actually doing dude! .. anyway, i'll make it an NC for sure. Being OFI or NC does not matter to me, because no matter what it is, the problem gotta be fixed. But I'm not happy about the auditor look at the finding this way. He just feel like it is an OFI instead of an NC.

Before the audit, I informed all the process owners to look at the procedures, but somehow we just missed on this one. So i'll make this an NC and have the auditor to audit the process again.

ok, let me clarify a little better. actually the procedure is extracted from previous QMS (also TS16949). There was a management takeover and the way they do things is different now.



:truce: I feel your pain. :truce:

:truce: I feel your pain. :truce:

Now you make me feel so much better. At least there's someone out there can feel my pain. The worst part is, I'm a lone ranger in achieving TS certification. Doc controller, Quality director, QA Eng, Technician = me! I see this as a golden opportunity to learn stuff. But there's no guarantee that I'll do it for the rest of my career. :bigwave:

So, are you the auditor's boss and the internal audit process owner? If so, draw up some auditor competencies and have him evaluated against them. If he doesn't make the grade, you can justify getting another group of auditors trained. Don't give up. You're required to be able to demonstrate competencies, so it's not personal on your part, you're simply doing what TS says you must.

My guess is that he didn't get any real training of any value, and has been doing it long enough without raising any eyebrows, either. Are you registered yet? If so, then a word in your registrar's ear might jolt them to investigate some things a little closer too. (Well, they would if you've got a good one!!)

Use the system to improve the system and help you (personally).

So, are you the auditor's boss and the internal audit process owner? If so, draw up some auditor competencies and have him evaluated against them. If he doesn't make the grade, you can justify getting another group of auditors trained. Don't give up. You're required to be able to demonstrate competencies, so it's not personal on your part, you're simply doing what TS says you must.

My guess is that he didn't get any real training of any value, and has been doing it long enough without raising any eyebrows, either. Are you registered yet? If so, then a word in your registrar's ear might jolt them to investigate some things a little closer too. (Well, they would if you've got a good one!!)

Use the system to improve the system and help you (personally).

yes, i'm the quality boss. i think the auditor just take the internal auditing process too lightly. he has been very helpful but the bad part is, he used to speak against the standards. we are planning to get certified by 2008 and next week, i'll be attending the lead auditor training. Is there any tip on what should i read before going for the training? how do they structure the final exam? I'd appreciate any input. Thanks.

The Lead Auditor class is intensive. You will do a lot in class and more in the evening. You should be very comfortable' with the ISO (and/or TS) requirements, so that you can focus on the auditing and auditor activities. The exam is usually open book, very little is about 'ISO' mostly it's about audit technique, includes multiple choice and true/false questions, essay answers to audit situations and non-conformance statement writing. At least our course is structured that way. Can't speak for other course providers.

Good luck!

The Lead Auditor class is intensive. You will do a lot in class and more in the evening. You should be very comfortable' with the ISO (and/or TS) requirements, so that you can focus on the auditing and auditor activities. The exam is usually open book, very little is about 'ISO' mostly it's about audit technique, includes multiple choice and true/false questions, essay answers to audit situations and non-conformance statement writing. At least our course is structured that way. Can't speak for other course providers.

Good luck!

Very informative. Thanks!

Good responses so far.

The auditor said TS 16949 is just a guideline--did I read that part right?

I also have stopped an audit in its tracks because the procedure was not sufficient to show the process complies with the standard--which, if you are already registered to TS or are in process, the standard is NOT a guideline.

However, I have also done the audit anyway, and used its walk through to highlight what needs to be changed in the document. Otherwise the document's owner is being left to his/her own document writing expertise. Not everyone is up to the job of making sure all the Shalls are covered in a coherent and usable procedure. If you do this, you can close the NC after reviewing the updated document.

This is also a potential document control matter. If this document was missed during a general update after management change, I'd want to ask how that update sweep was managed, and how the managers know that no other stragglers are out there.

Everyone has provided valuable information. I agree that the IA should be re-evaluated for competency.

You may also want to "Revise" the existing system to reflect "how" the business is running. New owners usually change the Business Processes to fit the style that they want.

This maybe a personal question, and you don't have to address it, if you don't want to...Why was the business sold?

As for the question of an NC or OFI: In my opinion, it would be a NC.

I'm overwhelmed by all the responds. Thank you! This is what I'm going to do. I'll make the OFI a minor NC and request the auditor to audit the procedure again. As for auditor competency, I'm sure he is well qualified to perform an audit. But, I think he is just trying to avoid the company being locked up by the QMS. As he always says, 'we control the system, the system does not control us' which i could not agree more.

I'm overwhelmed by all the responds. Thank you! This is what I'm going to do. I'll make the OFI a minor NC and request the auditor to audit the procedure again. As for auditor competency, I'm sure he is well qualified to perform an audit. But, I think he is just trying to avoid the company being locked up by the QMS. As he always says, 'we control the system, the system does not control us' which i could not agree more. Well, I do understand not wanting a company to be "locked up by the QMS", but are we registering to ISO or TS or not? If so, the Shalls must be addressed. How that's effectively done is up to the managers, not the auditor, except the auditor can act as a guide in the jungle of requirements, as it were.

The procedures need to be accurate, address the Shalls, address the system's needs, and address customer satisfaction--all at once. The auditor is tasked with evaluating how well the process addresses all these needs. While only a small number of documented procedures are required, there needs to be a designated manner for conducting many processes.

Sometimes we make procedures too complicated and then they don't get used. If a set of responsibilities, related documents and flowcharts/diagrams are enough to do the job, great. This might help avoid the feeling of lockdown, but the people need to understand overall that they have limits to their flexibility--and those limits need to be promulgated and audited.

So true Jennifer!:agree1:

A quality management system is a bit like a product. A poor product design cannot be made and then have quality inspected in.

In the same way, poorly written, overly bureacratic procedures etc., cannot be implemented well and no amount of auditing will improve things.

It's best to go back and re-evaluate the system to ensure no-one is 'locked down' by it, redesign (as required to make it more about the customers - aka the people who use it) and maybe the auditor will be a bit more 'for it' too........

I agree that it's an NC, no doubt about it. I think simplifying the documentation is a result of a system that is maturing. You start out doing way too much and then after things are going well you take the time to simplify, and make changes for the good of the company not ISO. Great thing about our system is that many in management are starting to seeing the parallel. Using ISO as a guide to improve our business and how we do things is becoming almost common place, a thing I could not have imagined a few years ago.

Just remember when you make changes as a result of an audit make them work for you. Simplify when possible so that people can understand what it is they should be doing. Make it too complex and they will do it their way!:notme:

Just an update on the Lead Auditor Course. I passed the exam. Thanks for all the support! :applause:

Just an update on the Lead Auditor Course. I passed the exam. Thanks for all the support! :applause:

Well done!:applause:

Now go out there and start making a difference...........;)

Just an update on the Lead Auditor Course. I passed the exam. Thanks for all the support! :applause:

Congratulations!!:agree1:

Congratulations on passing your exam, I hope you get compensated for the added responsibilities you should have now.

Congratulations on passing your exam, I hope you get compensated for the added responsibilities you should have now.

Now Dean, you know that's never going to happen. Stop building false hopes........:lmao::lmao::lmao:

Now Dean, you know that's never going to happen. Stop building false hopes........:lmao::lmao::lmao:

I for one am an optomist, just this last week-end I finally hit a jackpot on a slot machine at a casino :tg:. So there can always be that 1 in a million shot that a quality person can get the compensation they work for. :frust:

I for one am an optomist, just this last week-end I finally hit a jackpot on a slot machine at a casino :tg:. So there can always be that 1 in a million shot that a quality person can get the compensation they work for. :frust:

Ah, but them's not betting odds, Dean. 1 in a million?:lmao:

Congratulations on hitting the jackpot, btw.:applause:

Now Dean, you know that's never going to happen. Stop building false hopes........:lmao::lmao::lmao:


LOL!!!!! So true!!
I keep getting message telling me to make a change.. but i dont think that's going to happen any time soon!! LOL:biglaugh:

I for one am an optomist, just this last week-end I finally hit a jackpot on a slot machine at a casino :tg:. So there can always be that 1 in a million shot that a quality person can get the compensation they work for. :frust:

Congrats!

I must try my luck on this Friday's $325 Million jackpot. :lmao: