Conducting Limited Internal Audits of QMS Elements - Simple question I hope

M

mwilson5

#1
My boss and I have a disagreement. Is it permissible under ISO 9001:2008 for the Quality Administrator to conduct limited internal audits of QMS elements alone, or must a team of company personnel always be assembled and trained and conduct such audits?
 
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Wes Bucey

Prophet of Profit
#2
Re: Simple question I hope

My boss and I have a disagreement. Is it permissible under ISO 9001:2008 for the Quality Administrator to conduct limited internal audits of QMS elements alone, or must a team of company personnel always be assembled and trained and conduct such audits?
I would think the size of the audit team is constrained by the size of the organization. The only proscription (ban) is that the auditor should not audit his own work. (What do one-person shops do? [Always arrange for an outsider to come in? -doesn't seem very practical to assemble a whole team for a very small shop - who is left to audit?])
 

Stijloor

Leader
Super Moderator
#3
Re: Simple question I hope

My boss and I have a disagreement. Is it permissible under ISO 9001:2008 for the Quality Administrator to conduct limited internal audits of QMS elements alone, or must a team of company personnel always be assembled and trained and conduct such audits?
As long as this person does not audit her/his own work, it's OK.

Stijloor.
 
#4
Re: Simple question I hope

My boss and I have a disagreement. Is it permissible under ISO 9001:2008 for the Quality Administrator to conduct limited internal audits of QMS elements alone, or must a team of company personnel always be assembled and trained and conduct such audits?
A team might be a luxury! Internal audits (of most companies) rarely require a 'team'. They shouldn't be QMS-wide audits of several days. My experience is that they should be smaller, more focused audits, carried out by one person who is competent in both the audit process and the process (or scope) of the internal audit. Without knowing more details to help me, I'm not feeling good about 'teams' roaming around any organization doing an audit and that being all that's done to meet 8.2.2...
 
M

mwilson5

#5
Re: Simple question I hope

We are a company of about 750-800 employees. The element I audited was a very focused point in the documentation records area (the index of procedures verses the documents). It was limited to mainly ensuring the basic dates of procedures and number of changes, matched basic dates and number of changes entered on the index. As the QA Administrator, I do have a role in the documentation process, but it is limited to technical reviews of the content of documents themselves.

As you all know, a properly run QA/ISO function has a role in virtually all aspects of a company, and I don't consider reviews of technical and grammatical content of the text to exclude me from auditing the records the publications function generates. I ‘could’ select and train a team to do what I did, but it would take a long time to train them and results would not be as thorough since I totally understand the process, and those I would be training do not.
 
#6
Can I ask why you were auditing that particular 'element'? I've not encountered such an audit assignment before,,,
 
Last edited:
M

mwilson5

#7
Two years ago we had a total turnover of personnel in Publications, and the new team of tech writers are not doing a very good job of writing procedures. Since their records (procedure index, maintaining preventive maintenance scheduling as procedures are added and deleted) is not part of my review process, I felt their records should be audited 4.2.4 as much as control of documents under 4.2.3.

I might mention we are a service company, providing operation and maintenance of equipment and systems, so our procedures have to be maintained in top condition.

Thanks to all for the replies given!
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
#8
There is no reason not to conduct a spot audit like this - in fact I am not convinced it needs to be called an audit. It can be called a study or simply an investigation of effectiveness. We don't need to wait for an auditor to do that!

Being trained in auditing involves defining questions, interviewing (asking the questions), formulating NC statements, and following up for closure. If the results of your study indicate a need for an NC so as to focus efforts on resolution or to simply record this evolution in self-discovery and corrective action; by all means involve your auditors... maybe also to keep the whole improvement thing a team effort, I do not know if they are already looking at this or would wonder why they did not.

As internal auditor I have been asked to do spot audits too. But I used the process approach so as to understand the factors and what the eventual NC statement should most effectively be. I wonder if your auditors would do this service for you?
 

Wes Bucey

Prophet of Profit
#9
There is no reason not to conduct a spot audit like this - in fact I am not convinced it needs to be called an audit. It can be called a study or simply an investigation of effectiveness. We don't need to wait for an auditor to do that!

Being trained in auditing involves defining questions, interviewing (asking the questions), formulating NC statements, and following up for closure. If the results of your study indicate a need for an NC so as to focus efforts on resolution or to simply record this evolution in self-discovery and corrective action; by all means involve your auditors... maybe also to keep the whole improvement thing a team effort, I do not know if they are already looking at this or would wonder why they did not.

As internal auditor I have been asked to do spot audits too. But I used the process approach so as to understand the factors and what the eventual NC statement should most effectively be. I wonder if your auditors would do this service for you?
I agree with Jennifer - what mwilson5 describes is not strictly an audit - it is a study of effectiveness.

That said, I am not very comfortable with "outsiders" writing procedures and processes just because they are "tech writers." Where is the input from the folks actually carrying out those processes and procedures? This situation of
we had a total turnover of personnel in Publications, and the new team of tech writers are not doing a very good job of writing procedures.
gives me feelings of deja vu with a parallel of the folks who wrote the original Red Bead procedures for the Willing Workers (see "Deming's Red Beads")
 
W

whiskylass

#10
As already said as long as you are not auditing your own work then there should be no problem with this however, depending on the number of audits to be carried out it may put a strain on the rest of the work that you are required to carry out.

The organisation I work for is ISO 9001:2008 accredited, BRC accredited and we supply some major retailers and becuase of this my current internal audit programme consists of 49 audits so I have a team of 12 fully trained auditors to ensure each auditor only gets approx. 3 - 4 audits a year - a manageable amount they can fit into their daily tasks.

I think that you and your boss should have a 1:1 regarding this and discuss in detail what he is wanting from the audits and determine the number of audits to be carried out and then you can decide if it is too much for one person or not
 
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