Let the Registrar audit the Internal Audit process

C

curryassassin

#21
Because they are not the process owners, nor are they even part of the department that owns the process.

Being involved in a process <> conflict of interest.
Using that logic my QC inspectors can't be auditors because they are involved in every department in the company to some extent.
The problem I have is that you are using 2 of your auditors to audit the process that they appear to be involved in routinely. A trained management rep or consultant auditor is independent, and, possibly, more objective?

Your QC inspectors are part of the manufacturing process?:)
 
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tony s

Information Seeker
Trusted Information Resource
#22
External auditors usually assert that they are our partners in improving our management systems. I hope they would not think that they are being abused or we are trying to circumvent the "requirement" if we let them do a minor task that we think will add more value to our established systems.

tony s
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#23
If a registrar is making you feel as though the registration audit is a kind of consulting service, it's a misunderstanding or worse.

I really want you to understand that an organization needs to know, on its own, how well the audit program is functioning. The audit process is intended to assess compliance and, running the assumption that your QMS is responsive to such input, provide input suitable to recognize opportunities for improvement. If this process is not itself internally assessed, the organization runs the risk of not knowing when a gap in auditing exists. Clause 8.2.3 says we should monitor and, (where applicable) measure QMS processes, and that the methods are to demonstrate the ability of processes to achieve planned results. These QMS processes include the internal audit process.

By delegating the matter of assessing internal audits to your registrar, you are failing to recognize that you understand the need to examine how well you are doing assessments on your own. Even a small organization should be able to do it--you can use methods like trade internal audit services with another organization; you could be finding one via your area ASQ chapter.
 
#24
So how are your other 2 auditors independent when they are involved in the audit process?
Woa, matey..............they're not required to be 'independent'.......but they are required to be 'objective and impartial'........

There's no problem as long as the audits they use to sample are not theirs.
 
C

curryassassin

#25
Woa, matey..............they're not required to be 'independent'.......but they are required to be 'objective and impartial'........

There's no problem as long as the audits they use to sample are not theirs.
woa,woa,woa 'matey', OK, but what about their objectivity and impartiality to the process that they take part in??? Hmmmm????
 
#26
woa,woa,woa 'matey', OK, but what about their objectivity and impartiality to the process that they take part in??? Hmmmm????
Well, that's the challenge of auditor selection! I'm certain you have someone who is an open minded, 'big picture' person to do the audit. Maybe they will look at it objectively if they are familiar with the audit procedure. But beware that you might have to look at the thing differently, based on what they find!

(The 'matey' thing was supposed to be an attempt at a British term of endearment...........):D
 

BradM

Staff member
Admin
#27
I really want you to understand that an organization needs to know, on its own, how well the audit program is functioning. The audit process is intended to assess compliance and, running the assumption that your QMS is responsive to such input, provide input suitable to recognize opportunities for improvement. If this process is not itself internally assessed, the organization runs the risk of not knowing when a gap in auditing exists. Clause 8.2.3 says we should monitor and, (where applicable) measure QMS processes, and that the methods are to demonstrate the ability of processes to achieve planned results. These QMS processes include the internal audit process.
Excellent post, Jennifer. Thank you.

OK, I've got a question on this one. I am a profound believer in the internal audit program, and feels it's one of the strongest assets of the QMS. However, it sounds to me that audit the internal audit process is a bit too refined, and can lend to one auditor (with certain notions and biases) to be pitted against another (solely based on auditing practice). I'm perceiving auditing the auditor doing audits for the audit! Is not the effectiveness of the internal audit process not apparent in the audit program findings, CAPA, management actions, etc.? Those items are definitely auditable.

NOTE: I am not making a statement of fact, but of perception. Please correct where my thought process is in error.
 

Randy

Super Moderator
#28
Independance does not guarantee impartiality or objectivity, this discussion has happened many times. In the case of a small company independance may not be possible but impartiality and objectivity can be. It all boils down to the integrity and honesty of all involved in the process....management, the organization and the auditor.
 

Stijloor

Staff member
Super Moderator
#29
Excellent post, Jennifer. Thank you.

OK, I've got a question on this one. I am a profound believer in the internal audit program, and feels it's one of the strongest assets of the QMS. However, it sounds to me that audit the internal audit process is a bit too refined, and can lend to one auditor (with certain notions and biases) to be pitted against another (solely based on auditing practice). I'm perceiving auditing the auditor doing audits for the audit! Is not the effectiveness of the internal audit process not apparent in the audit program findings, CAPA, management actions, etc.? Those items are definitely auditable.

NOTE: I am not making a statement of fact, but of perception. Please correct where my thought process is in error.
Hello BradM,

Allow me to chime in here...

When I audit an audit process, I always examine how the audit results (good, bad, ugly) are used. There are a number of "beneficiaries" of the audit program that use the audit results: Top management, process owners, even the CB/Registrar. ISO 9001:2000 (for example) has a few direct links to "audit results": Review input 5.6.2 a) and Continual improvement 8.5.1; and indirectly: 8.5.2 Corrective action and 8.5.3 Preventive action.
Auditing is a process of discovering nonconformities, opportunities, and risks. A great tool that in many organizations is underutilized. The job of the external and/or internal auditor is to find out how this asset is used and if the results are used to improve the organization and its processes.

Sorry for "rambling", but this topic is near and dear to me.

Thanks for the great dialogue in this thread.

Stijloor.
 
C

curryassassin

#30
Well, that's the challenge of auditor selection! I'm certain you have someone who is an open minded, 'big picture' person to do the audit. Maybe they will look at it objectively if they are familiar with the audit procedure. But beware that you might have to look at the thing differently, based on what they find!

(The 'matey' thing was supposed to be an attempt at a British term of endearment...........):D
We are a small (<30) organisation, and one of our regulators has issued guidance on management auditing 'QA activities'. One the aims of the guidance is to audit that QA is independent of activities for which they are providing quality assurance. I take this to include the audit process.

I have passed a copy of their requirements to my management and requested that one of them (who is trained in the audit procedure) perform this audit, which they have done. I expect to have to review my process based on their findings.

I still believe that any auditor selected should come from outside the audit process to demonstrate complete objectivity and impartiality. I believe the audit process in general should demonstrate if we're doing what we say we're doing, we're adding value, we're satisfying internal/external customers, we're highlighting opportunities for continual improvement.

(The correct term should be 'mate', as in 'buddy' 'pal' 'chum', which I still regard you as (professionally also).:D
 
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