Auditing a process outside the realm of the formal Internal Audit

R

rvanelli

Involved In Discussions
Is it common place for one department to audit a process outside the realm of the formal internal audit process as described in 8.2.2?

For example what might the logic be for a trainer in the HR department to audit training records kept by other departments but the audit takes place outside the controls of 8.2.2, is not part of the audit schedule and the results not reported at management review? Would this be an unusual practice?
 
J

JoeDM

I don't know if I can relate to your specific example, but maybe I can give you one that might relate:

I am auditing the manufacturing process. The production workers are working to design drawings. While conducting the audit I notice that the worker has a drawing open at his work station. I look at the drawing and notice red line changes on the drawing that are not signed off by an engineer, as required by the QMS.

In this case, though I am not auditing design, I would write an CA to the design group because the drawing was changed without an approval.

The example is not exactly the same as yours because the design process is in the audit schedule somewhere, but it is not currently being audited.

When auditing a process, it is important that the auditor not audit with 'the blinders on'. It is appropriate to write a CA on a non related process, if the auditor stumbles on something.

Hope this helps.:)
 
Ninja

Ninja

Looking for Reality
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Let's step outside of the documents for a second and consider the big picture...a person employed by the company noticed something going on in the company that is contrary to what the company has decided should go on.

Proper reaction: Raise a flag so that it gets fixed and comes back into line of what the company has decided should go on.

The rest is just terminology and paperwork...call it a "Quality System Improvement"...call it a "Preventative action"...tie it to 8.2.2...or tie it to the hitching post outside...

It is totally acceptable (it is WANTED) that employees of the company who see something falling short of the desired target would act to bring it back on track. The only question left is how the company chooses to bring it back on track.
:2cents:

Oh, and to answer the question asked...it happens all the time in my department and the departments with which they interact, I strongly encourage it.
 
Last edited:
Jen Kirley

Jen Kirley

Quality and Auditing Expert
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rvanelli said:
Is it common place for one department to audit a process outside the realm of the formal internal audit process as described in 8.2.2?

For example what might the logic be for a trainer in the HR department to audit training records kept by other departments but the audit takes place outside the controls of 8.2.2, is not part of the audit schedule and the results not reported at management review? Would this be an unusual practice?
Click to expand...
I see nothing at all wrong with HR conducting oversight on other departmental training, which I presume was done to help ensure the departmental training was up to standards. I would argue that it represents a form of process control in training, and it's a good idea.

That said, in my view it is not a process audit of Training and can't substitute for one. However, I see no reason why its data can't be recognized by the regular auditor as an input to the audit on 6.2. In addition, I see no reason why not purposely plan to include this kind of help from subject matter experts in HR to assist the appointed person qualified as per 8.2.2.

I hope this makes sense!
 
I

isoalchemist

It happens all the time. You will certainly have the formal audit process set-up within the QMS, but random checks can occur at anytime by anyone. If issues are found certainly raise a NC and get it formally corrected in the system.

Internal audits are great tools to keep track of system health, but it's amazing how much a simple question "wonder what XXXX look like in....?" can uncover.
 
A

AndyN

Moved On
rvanelli said:
Is it common place for one department to audit a process outside the realm of the formal internal audit process as described in 8.2.2?

For example what might the logic be for a trainer in the HR department to audit training records kept by other departments but the audit takes place outside the controls of 8.2.2, is not part of the audit schedule and the results not reported at management review? Would this be an unusual practice?
Click to expand...

If you have an established audit program, why would anyone want to work outside of it? I would question the motives of the "informal" audits and also why the formal audit process isn't being used by those people. One way or another, you've got a problem on your hands!
 
B

Boingo-boingo

AndyN said:
If you have an established audit program, why would anyone want to work outside of it? I would question the motives of the "informal" audits and also why the formal audit process isn't being used by those people. One way or another, you've got a problem on your hands!
Click to expand...
As usual, we need much more information before we are able to pass meaningful judgement.

What if HR was checking on safety related training? That has nothing to do with ISO 9001 8.2.2, simply because safety is not covered in 9001.
 
A

AndyN

Moved On
Boingo-boingo said:
As usual, we need much more information before we are able to pass meaningful judgement.

What if HR was checking on safety related training? That has nothing to do with ISO 9001 8.2.2, simply because safety is not covered in 9001.
Click to expand...

Who says an internal audit program has to address only ISO 9001? My comment stands!:mg:
 
B

Boingo-boingo

AndyN said:
Who says an internal audit program has to address only ISO 9001? My comment stands!:mg:
Click to expand...
Certainly internal audits don't have to be confined to the QMS, but this thread is under ISO 9000, 9001 and 9004 and the original post in this thread mentioned ISO 9001 8.2.2.

I am just giving a potential scenario where HR was doing an audit/check of something that has nothing to do with the QMS and the QMS internal audit process.
 
A

AndyN

Moved On
Boingo-boingo said:
Certainly internal audits don't have to be confined to the QMS, but this thread is under ISO 9000, 9001 and 9004 and the original post in this thread mentioned ISO 9001 8.2.2.

I am just giving a potential scenario where HR was doing an audit/check of something that has nothing to do with the QMS and the QMS internal audit process.
Click to expand...

Right! Where else would you post a question if you are from an ISO 9001 reg. company and you have a question about internal audits, is what I'd ask. If they have a management supported IA process, where management participated in the process, they still wouldn't need to do audits "outside" of the program, they'd ask the question "what do we have to do to arrange an audit of "X". Since the OP isn't outside the remit of an ISO 9001 IA, anyways, the issue I raise is valid. We can run the "what if scenario" until the cows come home...
 
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