Need to follow-up Internal Audit 'Observations'

[Big Jim]

The practice of writing an observation when it is really a nonconformance is called "soft grading" and auditors are not permitted to do that.

Auditing with rigor requires that nonconformances be written when found, not "soft graded". Any auditor that practices "soft grading" is at risk with his certification body.

You are not required to follow up on observations and opportunities for improvement. If you have an auditor that expect that, you need another auditor.

 

[dksfwmcc]

The practice of writing an observation when it is really a nonconformance is called "soft grading" and auditors are not permitted to do that.

Auditing with rigor requires that nonconformances be written when found, not "soft graded". Any auditor that practices "soft grading" is at risk with his certification body.

You are not required to follow up on observations and opportunities for improvement. If you have an auditor that expect that, you need another auditor.

Dear Big Jim,

Thank you your last paragraph is exactly what I was looking for.

Regarding the 'soft grading' again I 100% agree; & just to confirm in our internal audits we do NOT do this; if something is a minor NCN we make it an minor NCN.

Regards

Si

 

[somashekar]

Si...
Big Jim is talking from the CB audit observations and OFI perhaps.
Looking at internal audits, the requirement is to take action without undue delay. The extent of the action based on sound root cause analysis must depend on the depth of the NC and how it will impact the QMS and business.
Grading NC's even before an action plan is not a welcome sign in an internal audit program. Less said the better about observations...

 

[TPMB4]

I'm curious as to what the OP means by NCN, minor NCN and observation. Are there any examples you can give? I'm relatively new to quality role so I am curious as to how this grading works.

If the observations by your internal auditors is resulting in the issue with the external auditor is there a way of reporting these outside of the formal audit? That way the decision as to actions for the observations can be taken outside of the audit and CA procedure. Perhaps the external auditor will then distinguish between the NCN and the observations and their different requirement level for action.

 

[Claes Gefvenberg]

From the perspective of the standard, it is either conforming and effective (see 8.2.2) or it is not. If it is not, it becomes a non conformance.

That is my view as well: That way you also save yourself from the endless squabbles about wether it is a major, minor, observation or what have you. It is much better to concentrate on what should be dealt with and if so how, than to waste time grading it.

/Claes

 

[insect warfare]

There is no such requirement in an internal audit program to record an "observation". Like Big Jim said, it can be referred to as "soft grading", and lends itself to gray areas. Either something is conforming or it is not conforming. However, it is perfectly fine for an internal auditor to record an "opportunity for improvement" where they feel they can be useful, regardless of whether something is conforming or not, but this requires the auditor to have a generalized understanding of the information at hand. The difficulty is compounded by ensuring that the person(s) responsible do in fact make rational and justifiable decisions based on the auditor's supplemental information.

Brian

 

[dksfwmcc]

I'm curious as to what the OP means by NCN, minor NCN and observation. Are there any examples you can give? I'm relatively new to quality role so I am curious as to how this grading works.

If the observations by your internal auditors is resulting in the issue with the external auditor is there a way of reporting these outside of the formal audit? That way the decision as to actions for the observations can be taken outside of the audit and CA procedure. Perhaps the external auditor will then distinguish between the NCN and the observations and their different requirement level for action.

Hi,

(from my DNV internal auditor training pack)...
1) Major NCN (non conformity notice) is either a 'major hole' in terms of docs or implementation OR a series of 'minor NCN'
2) Minor NCN is an isolated lapse
3) Observation is not a defined term, BUT there is a 'common unerstanding' that whilst NOT a finding it is something that is good practice & coulfd be used elsewhere in the organisation, or a point that the auditor feels COULD leads to a minor NCn in future audits.

The 3 points abaove are a summary, there is much more I could add regarding potential effect & other points, but every (competant) external auditor I have ever come across (that is thankfully the vast majority) has fundamentally the same understanding.

Hope this helps

 

[Richard Davison]

We had our first surveillance audit recently and the the need to formally address observations raised at the initial assessment audit was noted under "Observations and Suggestions for Improvement" and not as a non-conformance, minor or otherwise. We have an extremely good auditor and I've taken the decision to treat observations made as input for the Continual Improvement Procedure. We now process observations through the Corrective Action Procedure which provides documented evidence that we have dealt with them and ensures that they are included in the Management Review. It also means that if I conclude that an observation is not going to benefit the QMS I can show documented evidence of how I came to that conclusion.