Difficulty ?passing? Quality audits - Number of Major / Minor Nonconformances Allowed

Antonio Vieira

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Difficulty “passing” Quality audits - Number of Major / Minor Nonconformances Allowed

Hi all!

Some years ago if the organization has more than 10 minor nonconformities, it was normal to have a follow up audit after the registration audit. The registrar would send the audit team to the organization approximately 1 month after the registration audit, and registration will only be issued if the majority of those minor NC were closed in the follow up audit.
Now I see organizations with much more than 10 minor nonconformities and some with major NC, getting registration at the first audit without having to pay for any follow up audit. The closing of NC written in the first audit will only be checked at next year’s follow up audit.
It’s common sense that the reason for this process being eased, is competition between registrars – less audits, lower price...
Is this happening everywhere, or is just here?:(
 
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Duke Okes

#2
There is no magic number of nonconformities tha will cause a failure. It depends on the seriousness/risks involved (e.g., potential impact on customers), and whether they indicate a systemic failure or a lot of really minor issues. Companies have been registered since at least 1993 with more than 10, in my experience. It is likely also impacted by policies of the particular registrar.
 

Antonio Vieira

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The first time I was “submitted” to a quality audit for registration was back in 1992. ISO 9001:1987.
At that time in the first audit we had 6 or 7 small nonconformities. The registrar, the only working here at the time, said we need to have a follow up audit a month from that date.

What I can tell now is that, the QMS we had 14 years ago at that organization was much better than more than 99% of those that today pass the first audit and get registration easily.
I can assure this because now I still implement QMS (working as an independent consultant) and I’m also an auditor for a registration organization.
In my country, and some others, this is a real situation and well seen by everybody in the “business” here, what I’m not sure is if this is happening at other places.:(
 

Sidney Vianna

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#4
ANAB has recently released an Advisory Notice on this subject. Check this link. The basic problem is the fact that certification of management systems is not a regulated activity, competition has trivialized a good percentage of this business, but most importantly, the users of management system certificates (the customers of the certified suppliers and other stakeholders) are (for the most part) ignorant and oblivious to distortions of the process, promoted by "less-than-serious" players.
 
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Duke Okes

#5
António Vieira said:
The first time I was “submitted” to a quality audit for registration was back in 1992. ISO 9001:1987.
At that time in the first audit we had 6 or 7 small nonconformities. The registrar, the only working here at the time, said we need to have a follow up audit a month from that date.


Perhaps some registrars were looking for extra income back then, and wanted to return for that reason.

Again, it really depends on the nature of the NCs more than it does how many there are. I've helped several dozen companies through ISO 9001 (87, 94, 00 editions), QS-9000, and ISO/TS 16949. I've found few registrars, especially good ones such as DNV, BSI, etc., who nit-picked, but have heard of others (the ones that send you the faxes asking "would you like to get registered in 90 days?") who were very lax. So, there's variation, as with all processes. Pick a reliable registrar, build a good QMS, and operate the business with it.
 
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Jim Wynne

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#6
Re: Difficulty “passing” Quality audits - Number of Major / Minor Nonconformances All

Duke Okes said:
There is no magic number of nonconformities tha will cause a failure. It depends on the seriousness/risks involved (e.g., potential impact on customers), and whether they indicate a systemic failure or a lot of really minor issues. Companies have been registered since at least 1993 with more than 10, in my experience. It is likely also impacted by policies of the particular registrar.
A question: If "...a lot of really minor issues" is not evidence of "systemic failure," why bother bringing them up?
 
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Duke Okes

#7
Re: Difficulty “passing” Quality audits - Number of Major / Minor Nonconformances All

Jim Wynne said:
A question: If "...a lot of really minor issues" is not evidence of "systemic failure," why bother bringing them up?
Good question. Some auditors don't actually write them as nonconformities, but instead just point them out for the process owner to correct (as opposed to wrting a NC which would initiate a CAR ... adding more frustrating, non-value adding paperwork). Examples: Someone forgot to sign a purchase order (but only 1 of many issued which were signed), two gages out of 2000 found past-due by a month for calibration, ...

Others write up everything in order to "earn their pay." Others sit in the lunchroom most of the day reading Field & Stream. Others brag about the fact that the (audited) company is paying for him to drive a rented Jeep Grand Cherokee ...

And I'm not making these up ... they are real examples!
 

Antonio Vieira

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Re: Difficulty “passing” Quality audits - Number of Major / Minor Nonconformances Allowed

Perhaps I’ve explained myself not in the most correct way.
What I’m trying to say is more or less this:
Now here in Portugal only very small organizations are getting new ISO 9001 registration. The larger ones are almost all already registered.
My point of view is more on the QMS these small organizations are presenting in the first audit. If it was 10 years ago, none of them will get registration at the first time.
This way, what I’m trying to say is that getting registered ISO 9001 is much easier today, than it was some years ago.

The most important attribute that an auditor should have is good common sense. But, as registration is more and more a business, I think registrars are making us, as auditors, having too much good common sense...
The result of this option made by the registrars is the constant lost of creditability of this system.
This is what I would like to know if it’s happening everywhere, because here everybody can easily see it...:confused:
 
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Duke Okes

#9
Re: Difficulty “passing” Quality audits - Number of Major / Minor Nonconformances Allowed

António Vieira said:
Perhaps I’ve explained myself not in the most correct way. This is what I would like to know if it’s happening everywhere, because here everybody can easily see it...:confused:
I don't have the numbers to know whether or not is is also true in the U.S. However, I would say that the differences between the 1987 and the 2000 editions are significant not only in their format, but also in their intent. The earlier editions were very documentation and compliance focused. It's now more about having processes in place, measuring how well they are performing, and improving those where doing so will add greater value to the customer and/or business.

So maybe registrars have gotten better calibrated to the new intent, and rely on whether the organization has demonstrated the ability to carry out PDCA, rather than whether all the i's are dotted or the t's are crossed.
 

Antonio Vieira

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#10
Re: Difficulty “passing” Quality audits - Number of Major / Minor Nonconformances Allowed

It’s not because of the difference in the versions of the standard.
Now we can implement a totally new QMS at a company in less than 3 or 4 moths. Some years ago it would take at least 1 year to do the same job.
The prices of consultancy for the implementation od ISO 9001 have gone also to less than 1/5 of what it was at that time.
And with the early versions it was even easier to do it because they where more “direct” than this one.
People are making everything easier, including registration.
This not just a feeling I have, this is more that discussed with several colleagues here.

I also perform registration audits for a very large multinational registrar. It’s not that we are all closing our eyes to nonconformities; the trouble is that, as this is becoming more and more just a business, we are not being so much worried about important details as we were in the past.
Here it’s also happening another incredible thing. As major organizations made the obligation for their small suppliers to get registered, they are just choosing the easiest way of doing it – which means choosing the “right” registrar.
I think that here since this “thing” of certification started to be a business, the lost of credibility in the process is becoming more and more high.

If this is to be continuing this way, I’m sure that some day registrations are going to be sold as shoes...:mg:
 
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