Internal Audit quiz - Auditor Qualifications and Requirements

[FEUCHT]

Hello Cove,

I work in QC department. When I did an internal audit of our shop, my operations manager did an audit of the QC department because you are not supposed to audit your own department. When the API auditor audited us, he claims that the operations manager had to be qualified in some kind of way to be able to do the internal audit of the QC department. He mentioned some sort of quiz or something similar. Does anyone have any ideas of how to show competency of the internal auditor via a quiz or something similar? Any help would be greatly appreciated.

Thanks,

Jeramy

 

[John Broomfield]

Hello Cove,

I work in QC department. When I did an internal audit of our shop, my operations manager did an audit of the QC department because you are not supposed to audit your own department. When the API auditor audited us, he claims that the operations manager had to be qualified in some kind of way to be able to do the internal audit of the QC department. He mentioned some sort of quiz or something similar. Does anyone have any ideas of how to show competency of the internal auditor via a quiz or something similar? Any help would be greatly appreciated.

Thanks,

Jeramy

Jeramy,

You've already got the criteria for a competent auditor. After all you've verified the competence of your other auditors.

You could do the same for your ad hoc auditor the operations mgr. Perhaps set the same test to verify knowledge, observe the auditing to verify skills and ask the operations mgr to verify the recommended behaviors from ISO 19011. Lastly examine the audit report to see if is factual and includes a conclusion that answers the audit objective.

BTW, your audit programme could focus on processes instead of departments. This avoids the "you cannot audit your own department" trope. What the standard says is that you cannot audit your own work; if you are auditing a process that you and others do then avoid sampling your own work.

John

 

[AndyN]

Hello Cove,

I work in QC department. When I did an internal audit of our shop, my operations manager did an audit of the QC department because you are not supposed to audit your own department. When the API auditor audited us, he claims that the operations manager had to be qualified in some kind of way to be able to do the internal audit of the QC department. He mentioned some sort of quiz or something similar. Does anyone have any ideas of how to show competency of the internal auditor via a quiz or something similar? Any help would be greatly appreciated.

Thanks,

Jeramy

It might be worth sorting the "opinion" from the fact, first. Ask the API auditor where this is a requirement (He can't show you, because it's his [bad] opinion)

 

[FEUCHT]

John and AndyN,

Thank you for your thoughts on this subject. You helped me think outside the tiny box that I was thinking in. Much appreciated.

Thanks,

Jeramy

 

[AndyN]

He mentioned some sort of quiz or something similar.

Brings up an interesting thought. If you asked the API auditor the same thing - "Did you sit a quiz?", I wonder what the answer would be! I'd like to ask the same API auditor (why don't these people spend time here at the Cove?) "why can't competency be demonstrated from effective auditing"? and see their response...

 

[bluepagen]

Post above is well said.

We took our procedure for doing internal audits, and used it to document questions. Also added questions about dates of other audits following the documented schedule, was there evidence of competency for the internal auditor(s), things of that nature. Thhis was done along with some basic training about objectivity, taking and documenting samples and filling out the documents required.

 

[Randy]

That API auditor is so full of krap he'd put a flock of Geese to shame....With the following exception:

Is it written into any of your procedures that some type of qualification is required that the auditor picked up on and y'all either haven't identified (for lack of reading your own stuff), or have always ignored? I see this all the time that folks don't read what they state they are going to do and then, of course, it isn't done.

Go back and read your stuff

 

[ScottK]

<snip>
BTW, your audit programme could focus on processes instead of departments. This avoids the "you cannot audit your own department" trope. What the standard says is that you cannot audit your own work; if you are auditing a process that you and others do then avoid sampling your own work.

John

Interesting side note on that... An FDA inspector I once had told me that I, as quality manager, could not audit much of anything because it's all part of the QMS for which I am the "owner" and Management Representative.
She didn't write it up, but she made me remove myself from the annual audit plan for just about everything. Fortunately I have a lot trained internal auditors.

 

[AndyN]

Interesting side note on that... An FDA inspector I once had told me that I, as quality manager, could not audit much of anything because it's all part of the QMS for which I am the "owner" and Management Representative.
She didn't write it up, but she made me remove myself from the annual audit plan for just about everything. Fortunately I have a lot trained internal auditors.

And people complain about CB auditors doing goofy stuff...

 

[FEUCHT]

Randy,

Thanks for the information. The only thing stated in our Operating Procedure it states: Before any internal audits can begin, the system shall have qualified internal auditors who will perform the work. The auditors will have undergone specific training from a competent source. They will also have demonstrated their understating of auditing principles as well as the concepts of API Q1 ad ISO 9001-2008.

Appreciate everyone on the cove for the help