Repeat Major NC - What can happen during External Audit by Registrar

A

adaline

#1
Our company is Certifiied to ISO 9001. Last external audit our registrar issued a major non-compliance to us. We fixed the issue and are now ready for another audit. We recently discovered we have the SAME issue and expect to get issued another major non-compliance. What happens when a company gets a double major? (or - is issued a major two times)?:thanks:
 
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BradM

Staff member
Admin
#2
Re: Repeat Major Nonconformance - External Audit by Registrar

Our company is Certifiied to ISO 9001. Last external audit our registrar issued a major non-compliance to us. We fixed the issue and are now ready for another audit. We recently discovered we have the SAME issue and expect to get issued another major non-compliance. What happens when a company gets a double major? (or - is issued a major two times)?
Hello there! Welcome to the Cove!

OK, please don't take this wrong, but... If you had fixed the problem the first time, how could you have the same issue? Are you sure you fixed it the first time, or is it a slightly different problem?

I'll be interested to hear from our road-warrior auditors. But.. I can't imagine that it would be good. Primarily, I would think an auditor would be keenly concerned why the root cause was not determined last time and the process improved. How is management responding to this?

Do you care to share a bit about the major NC? You can change whatever you wish to keep anonymity, or you can leave it vague if you choose. But some information surrounding your situation may be helpful.
 
Last edited:

Stijloor

Staff member
Super Moderator
#3
Re: Repeat Major Nonconformance - External Audit by Registrar

Our company is Certifiied to ISO 9001. Last external audit our registrar issued a major non-compliance to us. We fixed the issue and are now ready for another audit. We recently discovered we have the SAME issue and expect to get issued another major non-compliance. What happens when a company gets a double major? (or - is issued a major two times)?:thanks:
Hello adaline,

Not good news.....A few questions:

  • How did Top Management respond to the first major NC?
  • Was the effectiveness of corrective action verified?
  • What have the internal auditors done between Major 1 and Major 2?
  • Have you had Management Reviews?
  • Was clause 5.6.3 considered?
I don't want to be negative, but it looks that your QMS is in serious disrepair and the CB may take action to decertify you. I hope for the best though....

Wishing you lots of strength.

Stijloor.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#4
Re: Repeat Major Nonconformance - External Audit by Registrar

What happens when a company gets a double major? (or - is issued a major two times)?
There is no cookie cutter answer here. If the CB is serious, they will look very seriously about your root cause evaluation process that allowed a major problem to recur. But it will depend on the specifics of the case, the seriousness of the auditor and the management of your organization.

As usual, I recommend an open dialogue with the auditor from your CB. If the problem is really significant, both you and the auditor should be interested in putting it to rest. But there are many variables at play. Even the categorization of the finding is dependent on the qualifications of the auditor, responsible for reporting it. Without details, it is very hard to provide more advice.
 

Randy

Super Moderator
#5
Re: Repeat Major Nonconformance - External Audit by Registrar

Our company is Certifiied to ISO 9001. Last external audit our registrar issued a major non-compliance to us. We fixed the issue and are now ready for another audit. We recently discovered we have the SAME issue and expect to get issued another major non-compliance. What happens when a company gets a double major? (or - is issued a major two times)?:thanks:
NC against the Corrective Action process.....the evidence exists that it doesn't work...by your own admission.

How do you fix it? Can't tell ya because I'd be crossing the line into consulting.

All I can say is read the requirement for Corrective Actions and actually do it.

As to the "double-major".....possible suspension or revocation of your certificate, which is pretty standard for the the industry. And don't believe it won't happen, it does and there are fiscal horror stories that come out of that scenario.
 

atitheya

Quite Involved in Discussions
#6
Re: Repeat Major Nonconformance - External Audit by Registrar

Our company is Certifiied to ISO 9001. Last external audit our registrar issued a major non-compliance to us. We fixed the issue and are now ready for another audit. We recently discovered we have the SAME issue and expect to get issued another major non-compliance. What happens when a company gets a double major? (or - is issued a major two times)?:thanks:
You probably carried out a "correction" after the earlier external audit. Root cause was not analysed and removed which resulted in repetition of the issue. Now that it has happened again, ACT NOW.

Analyse Root Cause, take corrective action by removing / repairing the cause, verify effectiveness of such corrective action essentially that it shall not happen again .

This is the least you need to do and DO THIS BEFORE YOUR DUE EXTERNAL AUDIT. Have a dialogue with your CB and ask for some time but only if you have to.
 

gpainter

Quite Involved in Discussions
#7
Re: Repeat Major Nonconformance - External Audit by Registrar

I think that it depends on the issue, the registrar and the maturity of the QMS. The old one will be re-opened and if not fixed then suspension
 
D

DsqrdDGD909

#8
Re: Repeat Major Nonconformance - External Audit by Registrar

Off topic - can one act as a consultant to one company but as an auditor to a different company, or is the rule you are either an auditor or a consultant?
 

Helmut Jilling

Auditor / Consultant
#9
Re: Repeat Major Nonconformance - External Audit by Registrar

Off topic - can one act as a consultant to one company but as an auditor to a different company, or is the rule you are either an auditor or a consultant?

You can do both, but not for the same client. I think it is actually better, because it gives one broader experience and depth. Same registrars may prohibit it, but that would be an internal rule.
 
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