ISO 9001 3rd Party Audit Preparation - Open Issues Aspects

[acook81]

I need advice. I just began working at a new company. The person before me was not experienced in ISO at all. They have an external audit coming up next month. I have found the entire system to be in complete ruins. Document control has no control, over 400 forms, a lot of repeated information on different forms, training records barely exist, Management has been lied to about # of open Corrective actions, There is so much, it would take me all day to list it.
How do I, a new person in this position, (Man. Rep./Lead Auditor) cover the companies butt for the upcoming audit. DO I just keep quite and only react to what the auditor finds or should I try to get a plan and timing together for fixing the system?
Please help.....

 

[Coury Ferguson]

Re: 3rd party audit prep

I need advice. I just began working at a new company. The person before me was not experienced in ISO at all. They have an external audit coming up next month. I have found the entire system to be in complete ruins. Document control has no control, over 400 forms, a lot of repeated information on different forms, training records barely exist, Management has been lied to about # of open Corrective actions, There is so much, it would take me all day to list it.
How do I, a new person in this position, (Man. Rep./Lead Auditor) cover the companies butt for the upcoming audit. DO I just keep quite and only react to what the auditor finds or should I try to get a plan and timing together for fixing the system?
Please help.....

Are you talking about a "Registration" audit to a specific standard, either ISO9001:2000 or TS?

 

[Jim Wynne]

Re: 3rd party audit prep

I need advice. I just began working at a new company. The person before me was not experienced in ISO at all. They have an external audit coming up next month. I have found the entire system to be in complete ruins. Document control has no control, over 400 forms, a lot of repeated information on different forms, training records barely exist, Management has been lied to about # of open Corrective actions, There is so much, it would take me all day to list it.
How do I, a new person in this position, (Man. Rep./Lead Auditor) cover the companies butt for the upcoming audit. DO I just keep quite and only react to what the auditor finds or should I try to get a plan and timing together for fixing the system?
Please help.....

You might have been hired as some sort of sacrificial lamb, or perhaps they hired you because they realize the mess and thought that you were the right person to deal with it. Above all, you need to make sure that the management of your company is aware of the current state of the system. In writing. Ask for guidance as to how they want to present the system mess to the auditor. Emphasize that it's supposed to be a quality management system, and emphasize "management." Hope for the best.

 

[ralphsulser]

Re: 3rd party audit prep

If you are already registered to ISO 9001 and this is a surveillance audit, I would immediately make sure top management knows the status. (Ref. Jim's comments)Then contact your registrar and ask for some additonal time due to the circumstances of the change of management reps. You would need some time to become aclimated to the details for the QMS.

 

[IEGeek - 2006]

Re: 3rd party audit prep

Ay yi yi...

Having been in this type of situation before this is absolutely a quandry. Good luck. Just kidding. Here is what I did and it worked out fine, but of course, every company and every auditor is different.

First things first - Conduct a Gap Analysis on the current system. Determine exactly what failures are there in comparison to your stated manual and certification (if applicable). List those gaps within the system and present to the most senior person in the company with or without your immediate supervisor (your call on that) At the same meeting prepare and present a timeline to correct all items. Be reasonable in your timeline and dont try to take on too much too quick. Get their buy-in on the whole process. I started by saying something similar to this -- " You hired me to oversee the quality systems and I am finding some serious gaps within those systems that I want to address and work on correcting."

Publish your plan to key stake holders (once approved by top dawg.) Let everyone know you are here to help and assist them in any way possible.

Now hit the low hanging fruit. What is going to make the biggest impact to the organization within the shortest time and make the auditor realize you are putting forth the effort to improve. Again, be realistic with your expectations and desired results.

If you know who your auditor is, call them, email them, send a carrier pigeon. Let them know you are the Management Rep. During this call also let them know that you are going to be working very dilligently on the systems and conducting a gap analysis and whatnot. Also mention that you have read all the N/C from last audit and are going to making sure that those are still in place and effective. (you have read them right?)

Follow up with stake holders. Hold progress meetings. Be firm in your deadlines and do not be afraid to escalate when you are met with resistance. I am guessing you will be, otherwise this mess would not exist.

Upon the auditor's arrival.... Be candid, don't lie and deluge them with information. Show or illustrate a viable before and after "picture" of the way things were upon your arrival and where they are now. Show them everything you are working on, notes, training records, meeting minutes, ICARs, etc. Let them get comfortable with the fact that while you are aware there are issues,you are doing everything to correct them and get the auditor confident in your ability to do so.

Then after auditor leaves (no matter the outcome) have an executive / senior management meeting immediately to address the N/C and auditor's findings. They should all be in the closing meeting anyway, so why let them leave?

Follow up with the auditor weekly to let them know your progress and then of course complete all N/C within the allotted time.

I know this is probably not what you wanted to hear, but having been through this I can tell you what worked for me. We experienced a major systemic problem and I discovered it on my third day of employment with a TS auditor due on site in two days. He became comfortable in my ability to bring it back on track that he did not see the necessity in filing a major N/C.

I hope this helps you and let me know if you need anything else. Here to help

 

[Craig H.]

Re: 3rd party audit prep

To build on what Jim has said, it is very important that you are specific as to what, EXACTLY, is wrong, lest you be seen as just bashing your predesessor. I would avoid emotionally charged words in the memo(s), but "tell it like it is".

Most managers hate surprises, but the longer you delay, the worse it will be.

Also, please help them keep in mind that these systemic problems also will have a direct impact upon the customers, and, ultimately the profitability, possibly the viability, of the firm.

 

[acook81]

Re: 3rd party audit prep

Thanks for all the input. To answer a few of your questions.
This is surveillance to ISO9001:2000
Yes I have reviewed the results form the last external audit and made some changes and progress towards the responses that were given to the auditor, but I am also finding out that the person before me filled out the reponses but did not do anything to fix the issues.
We are performing internal audits at this time to determine where we really are. (And it's not good)
I know I have to come up with some major plan here to hopefully by some time to fix things. I have ran into problems similar to this before, but never of this magnitude.
Of course being the new kid on the block, so to speak, is not helping matters. Although I have many years in the field, I am dealing with the normal BS from everyone. You know what I mean, run over the new person, tell them anything..blah, blah, blah. But I can stand my ground on that. Being an auditor for 11 years..I have heard it all before.....
Everything you have said sounds good, I kinda knew..but needed reinforcement..
Keep the ideas and help coming....
Thanks
Angie

 

[Coury Ferguson]

Re: 3rd party audit prep

Thanks for all the input. To answer a few of your questions.
This is surveillance to ISO9001:2000
Yes I have reviewed the results form the last external audit and made some changes and progress towards the responses that were given to the auditor, but I am also finding out that the person before me filled out the reponses but did not do anything to fix the issues.
We are performing internal audits at this time to determine where we really are. (And it's not good)
I know I have to come up with some major plan here to hopefully by some time to fix things. I have ran into problems similar to this before, but never of this magnitude.
Of course being the new kid on the block, so to speak, is not helping matters. Although I have many years in the field, I am dealing with the normal BS from everyone. You know what I mean, run over the new person, tell them anything..blah, blah, blah. But I can stand my ground on that. Being an auditor for 11 years..I have heard it all before.....
Everything you have said sounds good, I kinda knew..but needed reinforcement..
Keep the ideas and help coming....
Thanks
Angie

Angie,

When the original registration audit and surveillance audits thereof were performed, what has changed other then what you have defined, and excluding Management?

 

[C Emmons]

Re: 3rd Party Audit Preparation

I had previously left my company (then came back) - during the six months I was gone the system was stagnant....no management review activity, no internal audits, corrective actions were not addressed, customer complaints not documented, new hires not trained appropriately etc. I came back in just before a surv audit. I immediately documented and issued corrective actions for every area lacking - was completely honest about all of it, and had a plan in place to get the system back on track - Spoke to the auditor ahead of time and explained the situation - As the auditor could see we were already addressing the issues, had identified the problems ourselves - was foolish for him to write N/C on something we were already addressing.....
I would try this route...

 

[Randy]

Re: 3rd Party Audit Preparation

Have some good lunches planned

Trust me, I know a bit about this