In three days we will be audited, and I am really looking forward to getting it over with – almost to the point that the outcome is becoming irrelevant. Well, not really…

For the past couple of months, I have been waking up between 2:00 and 3:00 AM, and started thinking about ISO 9001:2000, and can’t go back to sleep. My mind is rested and going full speed, but my body needs more sleep… I am sure most of you are well familiar with this.

Some of the things that I know may still be a problem:
• Operators not having read the procedures.
• Managers not having read the Quality Manual all the way through, or some of the common procedures such as Document Control, Corrective Actions, etc.
• Although goals have been defined for each department and discussed with everyone, there will likely be someone(s?) who will say that they have never heard of any goals.
• Have I missed any forms that will show up during the audit?
• How many records are we not keeping that we should, and how many are we keeping that I have not listed?
• Although we have meticulously detailed instructions for many operations, there are still many more that are still lacking, but we are continually adding instructions and revising them. Will the auditor consider this on-going effort as ‘a glass half full’ or ‘as a glass half empty’?
• I have read and reread the ‘Common Pitfalls’ posted elsewhere in this wonderful forum; still, I wonder…..

What have I overlooked? What have I missed? :(

Any and all words of wisdom will be appreciated. :)

Alex

Alex, I recall going through the same trials you mention when we were registered for ISO 9001:2000 from ISO 9002:1994. I had been on the job for only 6 months and decided that whatever we missed the auditor would find and then it would only be a matter of working out the corrective actions left from the audit. It may sound too relaxed for some but it kept me from going crazy.

Jaime

1. BREATHE!! You are suffering the same anxiety I (and I am sure many others) did on the eve of the upgrade audit. There is no such thing as a perfect system, and the issues you have listed do not sound like "show stoppers". Try to think of your auditor as a helper, as opposed to an adversary (and hopefully you have one that looks at himself that way). There will always be the anxieties about the "people factor" before an audit. I hope you will be pleasantly surprised.

2. Take the day after (or the following Monday) of the audit off. You will need the break to recharge.

3. It will be OK! Promise... :yes:

Alex,

Almost none of what you have mentioned is required by the standard.

• Operators not having read the procedures.
(They only need to be able to find them and they have to accurately describe what they do. There is no requirement that you prove they actually read them)

• Managers not having read the Quality Manual all the way through, or some of the common procedures such as Document Control, Corrective Actions, etc.
(Again, there is no requirement for this.)

• Although goals have been defined for each department and discussed with everyone, there will likely be someone(s?) who will say that they have never heard of any goals.
(maybe, but that will not make you fail the audit. Now if EVERYONE said it, you may have a problem)

• Have I missed any forms that will show up during the audit?
(Probably, but as long as you got most of them, and you know you DID, it is not a big deal)

• How many records are we not keeping that we should, and how many are we keeping that I have not listed?
(Doesn't matter, the fix is easy if they are found, and I doubt you missed many)

• Although we have meticulously detailed instructions for many operations, there are still many more that are still lacking, but we are continually adding instructions and revising them. Will the auditor consider this on-going effort as ‘a glass half full’ or ‘as a glass half empty’?
(It doesn't matter, the auditor is not the one who decides what is appropriate to your business, YOU ARE. If he/she does not like it, TOUGH!)

• I have read and reread the ‘Common Pitfalls’ posted elsewhere in this wonderful forum; still, I wonder…..

Take a deep breath, although it is hard not to feel anxiety over it, remember, it isn't a big deal, EVERYONE PASSES!

Carl-

Alex,

Chill!
I remember writing an almost identical post before my registration audit. Some advice from a seasoned rookie:


No worries - you've been working hard and it will pay off.

Remember the sampling rules - the auditor will only dig when he/she smells something fishy. Majors are not handed out on the first sign of a weakness...they have to build a case first. Anomalies in your system shouldn't be that big of a deal, for the most part.

If your company's anything like mine, they'll welcome a few nonconformances. They want to know that registration is value-added. We made it through the registration with one minor - and I was a little disappointed. I know we're not perfect - and I don't want to pay a day rate of $1500 for someone to tell me that we are!

As for
Although we have meticulously detailed instructions for many operations, there are still many more that are still lacking, but we are continually adding instructions and revising them. Will the auditor consider this on-going effort as ‘a glass half full’ or ‘as a glass half empty’?

I wouldn't worry about it at all. You are not required to document each and every activity, nor do you want to - what a nightmare! I wouldn't stress about it - as long as you have documented your critical six, plus any that your organization views as critical, you're golden. Don't go too far in the other direction - overdocumentation is just as bad, in my opinion. Then you get into issues of "does this one match what we mentioned in that one" and stuff like that...

Relax and enjoy it - I know I was pretty wound about it as well, but in the end it all went smoothly. It wil probably go a lot better than you think!
Cheers,
-R.

PS: Let us know how it turns out!

What have I overlooked? What have I missed? :( Alex

Well I tell ya. . . you have done whatever you have had the ability to do. . . controlled what you have had control over. . . and now it's time to back off a tad. . .

Every time the band I play in changed a member, I had the fun task of training the new members. . . They had their own talent, and I had the ability to teach them the way we did things Arrangements) . . . in the end, the final test was the performance. Either they practiced what they were shown. . . or they didn't. . . In some cases THEY were the ones who stood out as being inept. . . not me. . . in some cases they practiced and did well.

In a nutshell, if you feel you have done whatever you could have, then be concerned about what you have control over. The rest is up to the rest of the team.

I recall my first "CORE AUDIT" under MIL-Q-9858A at the former Goodyear Areospace Co. we took months of preparation. Then hired in an independent audit team to assess where we stood. Made all the corrections that were offerred no matter how insignificant it seemed. And then the big day arrived teams of US Air Force and DCAS auditors arrived and after three weeks it was all over.
My point is todays audits can't compare to the old "CORE AUDITS" so relax, or go get drunk! We had one Program-QAE who ended up in a hospital with what we thought was a heart attack. Fortunately it was simply and anxiety attack.
Were there any findings you might ask? As a matter of fact the very first day the lead auditor walked into my department, went to the first work station, picked up a caliper and, to my horror, found that the calibration had expired! :bonk:
Go back to the basics and double check them, forget all else!
Any one else remember the dreaded CORE AUDITS?

A great Big Thanks For Your Comments - And here is why… :)

I just had a meeting with the CEO (my boss) and he is rather convinced that we are not going to make it, that is, that the auditors will find several ‘majors’.

You see, having grown up ‘within these walls’, he knows the system as well or better than anyone else, and knows where we may be lacking ‘from a perfect’ system point of view, as he wants to have someday. So he thinks we are going to fail when these deficiencies are found.

I see it differently. I see many very positive characteristics, especially for a remanufacturing business, and the deficiencies we do have are, to one extent or another, already being worked on. I just hope he can muster a positive outlook and attitude when we are audited.

FORTUNATELY, I then I read your thoughtful and accurate comments – and I was able to pick up my spirits from the floor and raise them to eye-level. I would like to share your comments with him...but I know better, so I'll just keep them to myself, and closely guarded.
:thanx:

Alex

A great Big Thanks For Your Comments - And here is why… :)

I just had a meeting with the CEO (my boss) and he is rather convinced that we are not going to make it, that is, that the auditors will find several ‘majors’.

Alex
If the auditor finds "majors," so what? You get a chance to fix what's wrong. I would find reason to be concerned if your ISO registration was keeping your organization from much needed business (you did not mention this). Besides, you need to show some improvement on the next round of audits so fixing what was wrong on the first audit gives you something to improve.

I once heard a quality professional from an aerospace firm say that his practice is to first take the external auditor to an area where there is a nonconformance. That always made the auditors happy to find something wrong and the rest of his audits go well from then.

I hope I am not sounding too complacent. I just know that my personal well being isn't worth all the certifications any auditor has ever recommended.

Jaime

p/s If you still continue to remain worried you can always call one of those places that guarantees a successful audit in 40 days :D

I once heard a quality professional from an aerospace firm say that his practice is to first take the external auditor to an area where there is a nonconformance. That always made the auditors happy to find something wrong and the rest of his audits go well from then.

Jaime


:topic: I can testify that this sort of thing was done all the time. I once seen the deputy program director present a product to the customer rep with the same approach.
The deputy, knowing that the product did have several non-conformances, and running out of time to fix them, and knowing the customers tendency to finish the inspection right after finding a non-conformance, did stand on the other side of the product from the customer. He had both hands on either side of the product and with the finger of his right hand pointed directly to a loose wire ( a relatively easy fix).
His hopes were that the customer would follow his finger, find the loose wire, Rant and Rave and demand it be fixed and not look any further.
Well it took about 2-minutes for the customer rep. to follow the finger and locate the loose wire and predictably ranted and raved and demanded that it be fixed. We fixed it the rep. stamped the shipper and left the building. We then proceeded to fix the other non-conformances. :rolleyes:

Just a quick note to "close" this thread:

You guys were right -
We were audited on 19 & 20 August.
Nonconformities found were as follows:
Majors = 0
Minors = 0
REF: My thread "Recommended For ISO 9001:2000 Registration!" of 20 August.

Thanks!

Alex

See, EVERYBODY passes.

Congrats!

Carl-

Carl,
See, EVERYBODY passes. -Congrats!
Maybe everyone here (Elsmar foum) 'passes', but as I have learned recently, many people don't make it on the first try, and many give up.

I just posted something in this regard: http://elsmar.com/Forums/showthread.php?t=7141&page=3

That having been said, I agree; Yes, you knew - and I did appreciate your confidence, as well as that of other contributors, which surely made my life easier.

BTW, does anyone know how many companies (percentage?) do not make it; i.e., where major non-conformities are found and require subsequent audits?

Alex

Hi to All,

We closed last week a second cycle of internal audits (all processes were audited) several non conformities were found and we are still finding the same issues that we found during the first cycle, we will have our fist certification audit next week,

These are the main issues found during the second cycle of audits:
1.-Procedures not being followed
2.-Some measuring devices not in control.
3.-Instructions not available at point of use
4.-Document control: using old rev's and documents of external origin not being controlled properly

What do you think? What CB auditors will be focused?
Is it possible to pass the registration audit ?
Please respond.:(

Hi Alex,
IMHO, Sleepness night almost happen to everyone preparing for a certification. You prepare a lot of things but when the Certifying Body
comes to audit you it seems that there are still lacking. The problem per se on some operators who have not read the procedures, then
the Supervisor should initiate the move that Operators be oriented on the procedures. Reading the Quality Manual is sometimes boring
on some Managers, but if you present it in a bullet presentation, contents, requirements during your weekly management meeting, I think it will never be another boring afternoon. In this regard, you need a support coming from Top Management to push this through. With regard to goals,
you need to discuss this every month to keep on track what other departments are doing.
As far as the requirements, just prepare the 6 mandatory procedures required (Doc Control, Control of Records, Control of Nonconforming, Internal Audit, Corrective Action and Preventive Action) + your Quality Manual.
Hope this helps.
Best regards,
Raffy

Hi Anerol,
As long as you can closed all main issues in due time, I think it will never be a problem that you will not pass the registration audit.
For me, Items no. 2 and 4 are critical. You should find a way to work on these immediately because if measuring devices are not
in control all products that undergoes using these devices is also not in control.
Sometimes, it depend on the auditors expertise, but most likely based on experience, they might focus on items 2 & 4.
You can do it.
Best regards,
Raffy
Hi to All,

We closed last week a second cycle of internal audits (all processes were audited) several non conformities were found and we are still finding the same issues that we found during the first cycle, we will have our fist certification audit next week,

These are the main issues found during the second cycle of audits:
1.-Procedures not being followed
2.-Some measuring devices not in control.
3.-Instructions not available at point of use
4.-Document control: using old rev's and documents of external origin not being controlled properly

What do you think? What CB auditors will be focused?
Is it possible to pass the registration audit ?
Please respond.:(