ISO 9001 Certification - Successful First Registration Audit? (Poll)

[db]

Rulers in the office were not calibrated (they are used for straight edges in non-engineering areas).
Training records did not indicate re-evaluation dates.
Three quality systems notices were not processed in a timely manner.
Three bottles of chemicals in the Test Lab were expired.
Each record does not specify owner, retention time, disposal method.

1) The ruler thing is stupid. How does the lack of calibration violate "Where necessary to ensure valid results?"
2) Where are training records (or training for that matter) required to have re-evaluation dates?
3) Where is "timely manner" stipulated?
4) Do expired chemicals matter?
5) Is this information kept somewhere else (such as a matrix)? Where is "owner" required?

It sounds like perhaps the last three may be valid, but the first two I would challenge (providing your documentation doesn't add any "shalls").

 

[SteelMaiden]

Rulers in the office were not calibrated (they are used for straight edges in non-engineering areas).
Training records did not indicate re-evaluation dates.
Three quality systems notices were not processed in a timely manner.
Three bottles of chemicals in the Test Lab were expired.
Each record does not specify owner, retention time, disposal method.

1 I'm with db on this, there is nothing that says that office rulers need to by calibrated if they are not being used to verify/release product.
2 Training does not need to be re-evaluated per the std.
3 What was the issue with "timely manner"? what did you do, what does the registrar say you need to do? I can see if you went weeks without notification on something, but did it affect customer satisfaction or product quality?
4 The chemicals, maybe, depending on what they were and do they really lose their effectiveness? Does your process require that they must be used prior to expiration date? Lots of things have an expiration date that really doesn't mean much. I have mild in my fridge that expired yesterday, I am not throwing it out (it's not soured), the expiration dates are more for the supplier to ensure inventory control and rotation in most cases. This one is probably a nonconformance, but you need to make that call.
5 Records, OK, if you don't show who is control of storage and retention information I'll give them that one for sure.

My advice to you is look at this stuff carefully, if you choose to do corrective actions, fine, if you feel that corrective action is not justified by risk/gain don't! Just make sure that you write up an investigation that supports your stance. (no way would you catch me calibrating rulers used by office staff, jmho)

 

[db]

1 I'm with db on this,

You might want to keep that part low-key. It could tarnish your reputation.

 

[Joe Cruse]

We just passed the certification audit to 9001:2000 (first try). I must admit my ideallist attitude towards the entire process has been shattered. Our auditors did not seem to know the standard or understand the spirit of the standard (which reminds me to find that other thread about registrars to vent my frustration). Our findings were:

Rulers in the office were not calibrated (they are used for straight edges in non-engineering areas).
Training records did not indicate re-evaluation dates.
Three quality systems notices were not processed in a timely manner.
Three bottles of chemicals in the Test Lab were expired.
Each record does not specify owner, retention time, disposal method.

I'd be arguing some of those, UNLESS the auditor found somewhere in your QMS that all those things were required by your own QMS. You may have written yourselves into those findings. If so, revise your QMS to keep from boxing yourself in a corner. If none of this was specified by your own QMS, you have legitimate issues with your registrar, and I'd fight the first 3 at least.


We made it on the first audit for 2000. No majors or minors, just a few OFI's, including possibly making a more detailed process map.

Joe

 

[SteelMaiden]

You might want to keep that part low-key. It could tarnish your reputation.

I'm pretty certain that any tarnishing has probably been done by myself, but if I ever need a scapegoat I'll blame you, OK?

 

[Cari Spears]

Christi -

If interested - I posted a similar situation to your #1 in the thread "Registrar Specific Requirements" on page 3.

Who is your registrar? Those first three do seem silly - unless they were written against your own internal "shalls".

 

[Rob Nix]

If, as Joe points out, those 5 issues above are not written requirements of your QMS (they certainly are not in the standard), then your auditor is just trying to find something/anything to report. From this I would guess you have a pretty tight system (they're grasping at straws).

I do find the results of the poll interesting (albeit the low sample size makes statistical validity questionable). If nearly ALL audits are passed the FIRST TIME, and we can reasonably argue that there are companies with excellent, medium, and poor QMS's, then just how effective ARE third party audits??? Everyone wins? Nobody loses? That's like giving all the children a prize no matter where they place in the race. I believe there are two reasons for the 100% first time registration results:

1) The whole system is not the altruistic effort to better the quality of companies across the globe. It is a money making venture on the part of registrars, auditors, consultants and trainers. You pay for a certificate. Period.

2) The schedules for registered auditors are tight (especially this year with ISO9K2K), so there are no time slots left for follow up audits for companies failing the first time. They must pass the first time as there is no time left to come back.

I don't know, maybe I'm being just a bit cynical.

 

[Icy Mountain]

Methinks I must protest

IMO, there are some even better reasons for the high First Pass Yield.
1)Most companies that are turning a profit have reasonable quality or they wouldn't have customers;
2)Most companies making enough profit to afford the resources necessary to document, train, record, audit, correct and pay the registrar for the paper have a pretty tight system and pretty good quality or they wouldn't have customers that pay them that much margin;
3)Most CEOs are not going to invest the resources in 2 without making sure you get the paper and a system that actually drives Continual Improvement. So, pay for consultant w/ experience and a pre-assessment (don't leave home without it) and I'd say you've got really good odds of registering the first time;
4)Finally, I don't know about the rest of you but my QMgr. job was on the line if we didn't register on schedule, I made d**n sure that we were ready!

 

[Rob Nix]

I agree that most companies have reasonably good systems. But don't you agree that there are many companies out there (some of our suppliers included) where you wonder how they ever got certified - on probably the first try! And there is also the uncanny ability of good auditors to find holes in even the best of management systems.

 

[SteelMaiden]

I do find the results of the poll interesting (albeit the low sample size makes statistical validity questionable). If nearly ALL audits are passed the FIRST TIME, and we can reasonably argue that there are companies with excellent, medium, and poor QMS's, then just how effective ARE third party audits??? Everyone wins? Nobody loses? That's like giving all the children a prize no matter where they place in the race. I believe there are two reasons for the 100% first time registration results:

1) The whole system is not the altruistic effort to better the quality of companies across the globe. It is a money making venture on the part of registrars, auditors, consultants and trainers. You pay for a certificate. Period.

2) The schedules for registered auditors are tight (especially this year with ISO9K2K), so there are no time slots left for follow up audits for companies failing the first time. They must pass the first time as there is no time left to come back.

I don't know, maybe I'm being just a bit cynical.

I think that the high first audit certification shown in the Cove poll is because the folks that inhabit this forum are all above average!

OK, now I've been nice to someone today, I can go back to being myself! lol