How to Identify "Observation" in Internal Audits?

T

Trevon

Currently our company just gone through external audit. The auditor asked me to identify how we define "Observation". She want me to clearly identify them in our procedure. Any one can help here? Thanks
 
P

piningg

Re: How to Identify "Observation" in internal audit?

Observation = Area of Concern right?
 
T

Trevon

Re: How to Identify "Observation" in internal audit?

thanks for the reply. I do answer auditor about these but she instead me to put more clearification about the "Observation" defination......
 

somashekar

Leader
Admin
Re: How to Identify "Observation" in internal audit?

thanks for the reply. I do answer auditor about these but she instead me to put more clearification about the "Observation" defination......
Hi Trevon ... why she ask you so ?
In an external audit these are tips for some changes you can do for better. You take it or leave it.
Within internal audit, you identify them and DO.
You are yourself and not your consultant or an external auditor to say any observations about your QMS operation. I do not really feel a need to go behind that work and add definitions to words. As long as you (and all in the comppany) see a situation to be fixed, changed, handled in a different way that will improve your QMS, Just DO it after a good thought and see what other processes also needs to be addressed along with it and DO.
 
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Re: How to Identify "Observation" in internal audit?

Within internal audit, you identify them and DO.
I agree with somashekar, Trevon. The standard does not require us to grade findings internally, we just need to deal with them. That said, maybe you already have something in your written procedures mentioning observations? If so, the request for a definiton becomes understandable.

/Claes
 

qusys

Trusted Information Resource
Re: How to Identify "Observation" in internal audit?

thanks for the reply. I do answer auditor about these but she instead me to put more clearification about the "Observation" defination......

This is my contribution:

OBSERVATION- A statement of fact made during an audit and substantiated by objective evidence. An audit observation can be a nonconformance (or finding), or data that may be useful in identifying preventive actions or opportunities for improvement.

Hope this helps:bigwave:
 
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AndyN

Moved On
Currently our company just gone through external audit. The auditor asked me to identify how we define "Observation". She want me to clearly identify them in our procedure. Any one can help here? Thanks

Your auditor is not doing their job. External auditors - I'm guessing this is a Certification auditor - have no right to ask for such a thing! If it was a customer audit the same thing applies, but you have to tread a little more carefully. In that case, you could decide if it is something to add, but no necessarily actually do.

If it is a CB auditor, did you get a non-conformance etc? If so, reject it. If not, if it was just a passing comment, I'd suggest you tell you CB's management that you don't appreciate such comments being made unless there's a clear requirement from the audit criteria (SIO 9001 perhaps?) or if they would benefit your internal audit, which they won't!
 

Kales Veggie

People: The Vital Few
Currently our company just gone through external audit. The auditor asked me to identify how we define "Observation". She want me to clearly identify them in our procedure. Any one can help here? Thanks

Here is my take:

If you allow "observation" as an audit finding in internal audits and you have a group of internal auditors, you should define "observation" or "OFI".

The main reason is consistency between auditors and their reported findings.

Second point is that "OFI", "Concerns" and "Observation" are often used to hide N/C, either the auditor did not do their job (finding more objective evidence) or it is to protect the auditee (fear !).

I think the external auditor is concerned about not calling N/C an N/C but hiding these in other findings.

I think that you should either define it or do away with it.

Here is my definition:
Observation: Observed poor practices that do not currently constitute non-conformances, but which make conformance difficult or provide opportunities for error. An opportunity for improvement – a situation that is not a non-conformance, but where the results are not optimal.
 

Randy

Super Moderator
Andy is right, unless in your procedure you said that auditors will find or develop them or something like that.
 
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