Recent ISO 9001 Re-registration Audit Questions

[qualityfox]

If all the auditor could find is minor details such as this, consider yourself lucky.
Your procedure apparently does say that any non-compliance will be recorded as a nonconformity and you recorded a non-compliance as an observation. When I started my ISO journey, my first boss cautioned me to always add a little "wiggle room" into procedures. If you wish to allow the recording of non-compliances as observations, then revise your procedure to allow it. Otherwise, enforce the "recorded as nonconformity" rule. It is your choice as to which way you go with it since the nonconformance was written against your own procedure.
I never argue little stuff like this with the registrar. Fix it and move on. I always pick my battles and this one isn't worth fighting over, imho.

 

[tpresnell]

I was told that unless we had objective evidence that we acted on the observations then the observations are only a suggestion. We were told that we need to issue NCR's so we will have objective evidence and therefore we would be able to close the loop. So, that goes back to the NCR we were issued... I don't know where to start on answering this NCR so that our answer is an acceptable answer.

 

[Helmut Jilling]

We recently went through our re-registraion audit and we received a NCR on Internal Audits. Apparently since we say that "A non-conformity is a non-compliance to the standard, codes, quality plan or documented procedures and is recorded as such."
The statement of Non-Conformance: Statements of non-compliance were not recorded as non-conformities, as required.
The evidence of the Non-Conformance: Indicated findings on non-compliance were recorded as observations, rather than as non-conformities.

I don't even know where to begin on answering this NCR. Can someone please help me.

Thanks

1. Apparently, internally, your procedure says noncompliances will be issued as "nonconformities." Generally, we take that to mean a corrective action is issued (and handled as a corrective action, I assume). You guys did not do that. So, yeah, that would be a finding in an audit.

2. The greater question, as several people asked, is whether your internal procedure should be modified to allow for simple issues to get simple correction. I teach that approach. But, meaningful internal issues would still be expected to receive proper, full, corrective action.

 

[AndyN]

I'll say it another way - someone created a monster and the CB auditor found that you hadn't been feeding the monster! KILL THE MONSTER!

So, for starters, edit your procedure to remove any reference to observations, and conflict between non-compliance and non-conformity. Use "non-conformity".

The use of grading is an external technique and has NO place in internal audits. It's the context/content of the actual non-conformity which has importance, not what you call it. Management will play games with words, rather than deal with the issue, and, without knowing it (I suspect) your CB is actually doing you a favour here by making you address it - but do it this way, not what they were expecting.

 

[Golfman25]

Do you have any examples of the "observations" which should have been non-conformances? Is there anything substantive or is it just bs?

 

[Reg Morrison]

If you wish to allow the recording of non-compliances as observations, then revise your procedure to allow it.

A procedure that contravenes a requirement of the standard can not be allowed and still claim compliance with the standard.

ISO 9001 invokes ISO 9000 as a normative standard. ISO 9000 has a definition for nonconformities and we MUST abide the definition when implementing and auditing a QMS against ISO 9001.

Further, ISO 9001:2008 section 8.2.2 clearly requires

The management responsible for the area being audited shall ensure that any necessary corrections and corrective actions are taken without undue delay to eliminate detected nonconformities and their causes.

So, any attempt to circumvent the need for corrections and corrective actions from a nonconformity by calling it an observation is misguided.

 

[tpresnell]

I would like to thank all of you for your responses. I'm going to compile your answers and hopefully come up with a answer to the NCR we received. I wish it was as easy as just changing our procedure that we have in place but the actual standard prevents us from doing that. As most of you know when I answer this NCR I have to answer it in a way that will guide our Internal Auditors to distinguish an observation from an actual NCR. Maybe the answer is more training I'm really not sure right now.

 

[AndyN]

I would like to thank all of you for your responses. I'm going to compile your answers and hopefully come up with a answer to the NCR we received. I wish it was as easy as just changing our procedure that we have in place but the actual standard prevents us from doing that. As most of you know when I answer this NCR I have to answer it in a way that will guide our Internal Auditors to distinguish an observation from an actual NCR. Maybe the answer is more training I'm really not sure right now.

The standard doesn't prevent you from changing the procedure! You report non-conformities as just that and keep away from any other "grade". Observations are just that - they are ANYTHING an auditor observes (compliant or not). I think you are going too far to copy what CB auditors do - often because they don't have time/ability to test the situation at hand to see what it really represents. Observations are simply "it has webbed feet and a bill, it could be a duck..."

 

[Sidney Vianna]

As ISO 19011 suggests, when disclosing the findings from the audits, we should report both compliance and noncompliance.

Observations, in my estimation, can be extremely helpful because auditors might identify situations where, while no requirements are being violated, there is room for improvement. For example, a work station that has not implemented good housekeeping practices.

Observations, such as noteworthy comments where a best practice is identified and, by being reported in the audit results, can now be shared with the rest of the organization.

Observations like reporting a major performance improvement since last audit (for example, on-time delivery improved from 78% to 94%) helps changing the misperception that audits are only focused on negative (noncompliance) issues.

When I taught (internal and lead) auditing, I tried to instill the notion that, in order for auditing to be better perceived, we must learn to report results in a more positive way. If we limit ourselves to disclose only nonconformities as a result of an audit, we would be (erroneously) associating auditing with fault-finding exercises and miss a great opportunity to identify improvement opportunities, best practices and significant accomplishments.

 

[Mark Meer]

According to ISO 9001, a nonconformity would typically lead to a corrective action request, while an observation (which is not mentioned anywhere in ISO 9001) doesn't.

I maintain that this appears to be just semantics. Words like "observation" or "finding" can (if undefined anywhere) be easily interpreted as "observed nonconformity" or "found nonconformity", or anything else...

The problem is really how the OP handles these things. If everything, be it a nonconformity, or opportunity for improvement are all considered audit "observations", then the simplest fix would be a small change to the procedure to define the criteria for which an "observation" warrants corrective-action.
...and it may very well be that this is already defined in a corrective action procedure...