When is the best time to Audit the Internal Audit Process?

T

treesei

#21
Andy,

That is because like any other part in QMS, internal audit is a process (or like a machine itself) and has its own structure. If we consider ISO 19011 compliance, there will be even more to think about. The job of internal audit of the IA process is to ensure that the machine works properly. In addition to what new/changed/not working, we need to do maintenance to ensure the old/unchanged/working is still working at the time of the audit and document the evidence to prove it. However, I do agree with you :) that the focus of an audit should be the new/changed/not working. Given the general average time spent and the quality of auditors in the real world, an audit would likely be sloppy if it were asked to audit the whole thing and also dig deep in every aspect.

Summary: We should audit the IA process in the same way we do with other processes in the QMS because all processes are "equal" abstractly. At least, we have to have documentation to prove that the process is working.
 
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John Broomfield

Staff member
Super Moderator
#22
Andy,

That is because like any other part in QMS, internal audit is a process (or like a machine itself) and has its own structure. If we consider ISO 19011 compliance, there will be even more to think about. The job of internal audit of the IA process is to ensure that the machine works properly. In addition to what new/changed/not working, we need to do maintenance to ensure the old/unchanged/working is still working at the time of the audit and document the evidence to prove it. However, I do agree with you :) that the focus of an audit should be the new/changed/not working. Given the general average time spent and the quality of auditors in the real world, an audit would likely be sloppy if it were asked to audit the whole thing and also dig deep in every aspect.

Summary: We should audit the IA process in the same way we do with other processes in the QMS because all processes are "equal" abstractly. At least, we have to have documentation to prove that the process is working.
treesei,

We have to be careful not to duplicate or replace management, supervision and process monitoring with audit.

Operators, supervisors and managers need to know for themselves that the process is working long before the auditor takes a sample.

If I was asked to audit an unmonitored process (including auditing) I would report an 8.2.3 nonconformity.

John
 
T

treesei

#23
John,

Excellent point. Yes we must make sure that monitored processes are routinely monitored. Internal audits absolutely should not be used to replace such monitoring by the responsible persons.

Now it occurred to me that my background of being in the US medical device industry may affect my thoughts toward internal audits. The US FDA's cGMP regulations for medical devices includes some very clear requirements for internal audit (21 CFR 820.22 Quality audit). In order to show the FDA that we did everything they want for IA, we audit our IA process to make sure things are working before the FDA inspectors review the process.
 
K

Ka Pilo

#24
Re: When is the best time to audit internal audit process?

What do you consider factors to make this difficult? I can address each specific item, rather than generalities.
Let’s start with scheduling audits as one of the factors that make it difficult. In order to gather info about actual audit you need to allocate "auditors to evaluate internal audit process" congruent to the number of "internal auditors who conducted the internal audit". One auditor cannot look at how all internal auditors do things and identify any departure from auditing procedure. In my experience internal audit team split into smaller groups to cover a number of areas simultaneously. Maybe the intent should not to audit every auditor or internal audit activities. Instead, take a sample and make a judgment as to whether the audit process is operating in accordance with the procedure, satisfying the standard and is effective.
 
#25
Re: When is the best time to audit internal audit process?

Let’s start with scheduling audits as one of the factors that make it difficult. In order to gather info about actual audit you need to allocate "auditors to evaluate internal audit process" congruent to the number of "internal auditors who conducted the internal audit". One auditor cannot look at how all internal auditors do things and identify any departure from auditing procedure. In my experience internal audit team split into smaller groups to cover a number of areas simultaneously. Maybe the intent should not to audit every auditor or internal audit activities. Instead, take a sample and make a judgment as to whether the audit process is operating in accordance with the procedure, satisfying the standard and is effective.
I don't understand why auditing the actual audit process is going to be a problem, based on schedule! Allocating one auditor to observe the audit process being followed should be one of the easier things to do...
If you use 'status and importance' as the guide to why you'd audit the audit process, it becomes a lot easier.
Are there other factors you believe make this difficult? I thought you'd suggested there were more...
 
J

Jason PCSwitches

#26
This whole thing is crazy to me. You audit that auditing process (program) not the auditors. You want to ensure that an I.A. process is in-place, implemented, adhered to, & effective.

Each auditor will have a report or record on file to record the I.A. they conducted. These are usually maintained in a central location (this is what a C.B. usually looks at as part of their audit) and should be reviewed. This will allow you to determine many many things about the process and individual auditor (competency).

I have found that since I.A's are a big focus of a C.B. audit it's best to conduct the internal audit of the process just prior (1-2 months) to a scheduled 3rd party audit. This gives you time to implement any C/A's and to verify effectiveness.
 
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