ISO 9001 3rd Party Audit Preparation - Open Issues Aspects

[EtobiLad - 2009]

This is surveillance to ISO9001:2000
Angie

This one is a toughie!

Just wanted to thank everyone again for their input during my time of need. We completed our audit today and we only got one NC and no OFI.

Congratulations, and well done. We had ours (reg audit) a week ago now..
Kudos!

 

[acook81]

I just wanted to thank everyone again and let you know that all of your good advice really helped. The Cove is a great place!!!!
I have quite the challenge ahead of me and I plan on sharing the journey with fellow cover's and especially newbie's. The site has always been a great help to me and I hope that my input will be a great help to someone else.

When I was hired into this position, the Quality Manager was aware of the trouble the system was in, he fought to hire me to help him out. He told me he needed someone aggresive that could help motivate the process owners of the QMS. He did not know the magnitude of issues the system was in until I came on board and begin reviewing the system.

The QMS was in really bad shape, I didn't know if I should just junk it and start over or try to fix it But I took some good advice from all of you and I just tackled it. I have been doing this for a long time and I knew I could figure out what needed to be done. The problem was getting top management to do it. I had meetings with Top Management and I told them the situation and what I felt needed to be done. I got a lot of crap at first, there was even talk of wanting to just do away with ISO. So I had to convince the Top Dogs that even without ISO they still need to manage their system (processes), they still have to satisfy the customer, they still have to identify and fix problems, etc., etc. And because I am one of many people in this position over the last 5 years, that I am not there to change the way they do things, but to help them identify issues and find real solutions and hopefully make things easier for them and how, if implemented correctly, QMS can do just that. And some how I got through to them.

We identified several NC's in the system and we decided what was most important, it was of course documents (information used) and corrective and preventive actions. These were two area's that were wrote up in the last external audit. So that is two of the required procedures for ISO. The plant manager had me write a corrective action against him for control of documents and we put together a plan to review all documentation.

For documentation (work instructions, records, etc) the system is overflowing with documents that were made up and hardly ever used, there were many rev levels of documents available on the production floor. There are over 50 books of work instructions where revisions have been made, but not all books were updated. There are over 400 forms and many of them are the same information in a different format. The Quality Manual was made up of 22 different word documents, all at a different revision level.
The main focus here is to identify and control what is actually being used and needed and to get rid of what is obsolete. We have began the review and it will take some time to complete. But I have management support and everyone is doing what they have been asked to do. I will just have to keep the momentum up.
The corrective/preventive action process has been going through major improvements since I began working here. We have closed about 240 corrective actions. Don't get excited..most of them had no information and we just had to bite the bullet and close them. But for that process we have set time limits on answering, we are requiring better root cause analysis to properly identify the issue and we are requiring proper follow-up on all open issues. And it will be properly managed and monitored.

We are going to start off reviewing the required procedures and we have a good start with Documentation and Corrective action. We have already retrained an audit team and they will start working out the bugs of the system.

So all of you probably want to know how we got through the audit. In a nutshell we dazzled him with brilliance. We told him that we had identified the issues as being systemic (plant wide, across the whole organization) and we had evidence that we had addressed and put plans in place to correct and "continuously improve the effectiveness" of the system. We told him details of our plans, what we had done so far and where we expect to be by the next audit. Of course during this we stayed within the scope of his audit, if it came up, we had a plan to improve it. If it didn't come up, we didn't discuss it. We made sure we could talk our way through the sections being audited and prayed for the best. :
And it worked. We only got one nonconformance for a torque wrench that should have been in the calibration lab, but was being used on the floor. That was it!!!!
So I have a lot of work to do, but I will periodically report to the Cove on my progress and what I have done.
Once again, thanks to all of you..I only hope I can be as helpful one day.

 

[Ajit Basrur]

Angie,

This is great success story and you require full applause for this.

But in the Organisational interest, you should prevent such incidences happening in the future by having a "Lessons Learnt". You should also train someone equally competent like you to take care of these in your absence.

 

[Sidney Vianna]

So all of you probably want to know how we got through the audit. In a nutshell we dazzled him with brilliance. We told him that we had identified the issues as being systemic (plant wide, across the whole organization) and we had evidence that we had addressed and put plans in place to correct and "continuously improve the effectiveness" of the system. We told him details of our plans, what we had done so far and where we expect to be by the next audit. Of course during this we stayed within the scope of his audit, if it came up, we had a plan to improve it. If it didn't come up, we didn't discuss it. We made sure we could talk our way through the sections being audited and prayed for the best. :
And it worked. We only got one nonconformance for a torque wrench that should have been in the calibration lab, but was being used on the floor. That was it!!!!

I am sorry you feel you succeeded. If the disparity about your quality system and compliance to ISO 9001 is so large, going through an audit and having only one minor like you described, is a shame. I don't know if you think the auditor was helpful by being so "understanding and trusting" that good intentions will be put into action, but the way I see it, he (the external auditor) did you a HUGE disservice. I am sure that some of the top managers must be thinking why are you so worried if the registrar gave you a clean bill of health. Had the auditor done his job, you would have more ammunition in your pocket to drive the changes that you feel are necessary for your QMS.
Imagine this same auditor audits one of your problem suppliers. Would you feel that he is forcing that supplier to shape up?
Sad state of affairs....This is one CLEAR EXAMPLE of why so many people question the value of management system certificates...

 

[potdar]

Angie,

As I had said long ago, there are normally two culprits in the situation you found yourself in. The Top Management and the Registrar.

I am happy for you that you could successfully tackle your management and enlist their support. I hope for your sake that you succeed in retaining it.

But the other culprit continues to remain a culprit. You never tried to enlist his help, rather dissuaded him from helping you if he ever wished to.

Again to quote myself, "If your registrar has accepted the state of affairs for so long,there's no reason why he will bother to raise problems this time. Just relax." Dont you think thats what has happened?

Anyway, getting the management on your side is a big achievement in itself. Maybe next time you could ask your auditor to tighten the belt for you. Mind you, the fellow will not do it unless you specifically ask him to. And he may not do it even after you ask him to. In that case, please chuck him without a second thought.

 

[Wes Bucey]

I am sorry you feel you succeeded. If the disparity about your quality system and compliance to ISO 9001 is so large, going through an audit and having only one minor like you described, is a shame. I don't know if you think the auditor was helpful by being so "understanding and trusting" that good intentions will be put into action, but the way I see it, he (the external auditor) did you a HUGE disservice. I am sure that some of the top managers must be thinking why are you so worried if the registrar gave you a clean bill of health. Had the auditor done his job, you would have more ammunition in your pocket to drive the changes that you feel are necessary for your QMS.
Imagine this same auditor audits one of your problem suppliers. Would you feel that he is forcing that supplier to shape up?
Sad state of affairs....This is one CLEAR EXAMPLE of why so many people question the value of management system certificates...

I wonder if we are missing something here? I presume there was a "laundry list" of nagging n/c which had to be cleaned up. Is the auditor expecting to receive "closeouts" showing that the plans for cleaning up actually were implemented and were successful?

If not, I agree the auditor was seduced into abandoning his duty.

 

[acook81]

I am sorry you feel you succeeded. If the disparity about your quality system and compliance to ISO 9001 is so large, going through an audit and having only one minor like you described, is a shame. I don't know if you think the auditor was helpful by being so "understanding and trusting" that good intentions will be put into action, but the way I see it, he (the external auditor) did you a HUGE disservice. I am sure that some of the top managers must be thinking why are you so worried if the registrar gave you a clean bill of health. Had the auditor done his job, you would have more ammunition in your pocket to drive the changes that you feel are necessary for your QMS.
Imagine this same auditor audits one of your problem suppliers. Would you feel that he is forcing that supplier to shape up?
Sad state of affairs....This is one CLEAR EXAMPLE of why so many people question the value of management system certificates...

I do not agree, it was not an easy job to convince the auditor that we had a plan to fix everything. He was not easy on us by no means. There would have been many NC's if not for the fact that I got everyone on board and identified exactly what was wrong and what needed to be fixed. Corrective actions were all in place and plans laid out, it would not have been any benefit to us for the auditor to write additional corrective actions on top of what we have already written. This is the same auditor they have had for years, he had never dealt with anyone like me in the organization, no one has ever sat down with him and said "Look, this is the problem, this is why it's a problem and this is what we are going to do to fix it. Beleive me, if we don't show a hugh amount of progress, the next audit will be a nightmare. I didn't just sail through this audit with a slap on the hand. It took a lot of hard work and convincing the auditor that finally someone who knew what to do is trying to tackle this system and fix it and Top Management was there to backup and support the changes. Just because we sailed through the audit doesn't really mean anything to me, it just means we have a lot of hard work ahead of us for the next audit, it won't easy.

 

[acook81]

I wonder if we are missing something here? I presume there was a "laundry list" of nagging n/c which had to be cleaned up. Is the auditor expecting to receive "closeouts" showing that the plans for cleaning up actually were implemented and were successful?

If not, I agree the auditor was seduced into abandoning his duty.

And yes, there were many NC's that we "cleaned up" prior to the audit. And we had to show a lot of progress and answer to open issues from previous audits. The auditor is expecting closeout for the issues. As I said in previous post, it is by no means over, we committed ourselves to a major improvement in our system and he expects to see those changes next time.

 

[Sidney Vianna]

Corrective actions were all in place and plans laid out, it would not have been any benefit to us for the auditor to write additional corrective actions on top of what we have already written.

I would agree with that, provided your organization had a robust corrective action in place. You mentioned yourself that corrective action was one of primary sources of problems during the last external audit and you had to close 240 NCs for lack of information. And root cause analysis is a work in progress over there. So, based on your description of the situation, there is a degree of wishful thinking here, meaning that what you presented to the external auditor might not really happen. Don't forget you posted:

And with everything I am finding thus far, I really wonder about the credibility of the 3rd party auditor. I mean, how have things went on this long and not been brought up by a 3rd party.

Maybe, just maybe, your external auditor has been presented with promises and grandiose plans every time he came to audit this organization. And his memory might not be that great....Good intentions are great. But the certificate does not state that your organization has good intentions. It states that your system comply with the ISO 9001 Standard. With so many holes and gaps, as YOU described, there is a lingering question about the certifiability of the QMS.
I have no doubt that you are personally committed to the improvement you mentioned. But the rest of the organization is a BIG question mark, based on your account of the organization. It is very typical for top management to "see the light" and "become committed" a couple of months before an external audit, but their attitude and priorities magically change after another "successful" audit. Back to business.

Obviously this might be a case of me being overly pessimistic. Keep up the good work over there and good luck.

 

[BradM]

Angie,

Thank you for checking up with us. It's really great to hear how things went. UNDERSTAND: I don't think anyone here is 'busting your chops', or suggesting that you did not do a fabulous job. I bet things would not have went so well without your efforts.

There's just people here on the Cove that have gone through this stuff for years and years and years. Saying, they're afraid that your management may have done just enough to get your auditor down the road for another year. Just be willing to accept that may be a distinct probability.

I sure hope I'm wrong, and that you have been able to convince your management that it's time to get right, or they lose their certification. Too, we hope that your auditor is helping your organization, and not hurting them.