The Role of the Process Audit in ISO 9000 Internal Audits

M

M Greenaway

#11
Jim

How do you get over the problem that not all ISO9001 requirements will be documented in the QMS ?

It seems that the desktop review you talk of is just to confirm that certain 'documentation' exists. Isnt documentation just a very small requirement of the standard ?

For example the question of competency, we have no procedure on competency, hence a desktop review will not identify that we address this issue, and if we only audit procedures to determine implementation and maintenance, then again we will not touch on this issue.
 
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M

M Greenaway

#12
Jim

If this 'compliance checklist' is only looked at by the desk checker, how do we determine implementation and effectiveness ?

You argument appeared to be that someone checks the documents to the standard, then someone else checks the working practice to the documents. This argument is based on 'documents for everything' which as you say is very old hat.

Also the statement 'we, (as part of normal good management) make sure that we are doing what we'd said', is based on the huge assumption of 'normal good managers' existing and doing their job properly, which is such a massively blind assumption you might as well spread the whole assumption to everyone and everything in the system, and not bother to audit at all, as it is the purpose of the audit to determine this (and other things).
 
C

Craig H.

#13
Jim Wade said:
"The trick is to provide a document that the registrar considers 'part of the QMS' but we know it isn't really - because we don't need it for
our management system to operate well and no-one else (other than the desk-checker) will ever see it. That document slavishly spells out each 9001 requirement and specifies how we will handle it. It is essentially a compliance checklist."

Ours is called the Quality Manual. The old clause-by-clause approach has its advantages. The main user of this document is our third-party auditor.
 
M

M Greenaway

#14
Exactly Craig

Its a re-creation of the useless Quality Manual isnt it !

Why have such a document, and why have such a pointless audit ?
 
M

M Greenaway

#15
Jim

You say you only work with companies with committed managers, which I guess always do everything right, but our audit is also a statement of compliance (not just non-compliance).

So even if we have the best managers in the world who always do everything right, isnt it healthy to have someone independently confirm that everything is continuing OK ?

Is it healthy to think that our managers will always do everything right, even if they are the most committed people we know ?
 
C

Craig H.

#16
Back to the original question, may I restate what I gather the problem at hand is and offer a solution?

If I have read this right, the problem is that Raffy's organization is about to get caught in an impending audit with no internal audits recorded. Right?

It is up to you, Raffy, to determine the frequency of internal audits (at least for 9000). So, why not do one big one, right now? Not only will you cover your requirements, you will have a chance to make sure the "shalls" are covered - sort of a preassessment. If you can do this along with having some "value added" findings, maybe you can sell upper management on the idea of more frequent audits.

I knew I was uncomfortable with the idea of relying on customer audits, but couldn't figure out exactly why. Now, I know - what are the customers auditing to? Their approach will be from their prospective, NOT what is best for your company and its QMS.

In a way, I wish we could call quality audits something different. The word "audit" conjures up images of the IRS (the US tax/inquisition agency) audit. In a way, quality auditing can be a more exact use of the "Management by Walking Around" management method, or am I oversimplifying??
 
M

M Greenaway

#17
Yes Jim, it is managements job, and the tool they can use is internal auditing - as the purpose of this is to report to management.

We cant just 'accept' that management do a great job can we ?
 
F

Fire Girl

#18
Very interesting!

Here's my 2 cents...

I just had this very discussion with my auditor. He looked at how I had my internal audit procedure set up. He asked, do we run our business how the standard is layed out? Nope, not really. He recommended that we audit by process as it is more realistic. A series of processes is what we do. He suggested that we show that we are meeting the standard. It's ok to still do traditional internal audits but he felt that we would get more out of internal auditing if we audited by job traveler, purchase order, all kinds of different ways. As long as all the elements are being covered in some way shape or form... well done.

Fire Girl
 
J
#19
If we add a product audit into the mix
Product Audits: Focus is on product compliance to established specifications and/or industry standards. Verification consists of an inspection of manufactured product against the requirements for that product.Were as Process Audits Focus is on the manufacturing process. Verification consists of a comparison of actual practices against applicable process documentation. Inherent to all process audits is an assessment of the competence of the Operator to properly and consistently execute the process using the system . Which leaves us with, Quality System Audits: Focus is on the application of Documented Systems that provide the umbrella of procedural support for the Company. Basically its a Level 1, 2 & 3 audit each used to monitor specific requirments of each level with the system audits being Level 1, and the Process audit being level 2, and the Product audit being level 3. All which are aimed at customer satisfaction thru continious improvment
:frust:
There is a distinct difference. Hope this helps....
 
M

M Greenaway

#20
Interesting document attached from the AIAG, who have a lot to do with QS9000, and now TS16949 (which is based on ISO9001:2000), regarding the 'new' approach to auditing processes.

As the third paragraph points out you now have to audit a process, and then check back to the relevant requirement of the standard, rather than trawl through the standard line by line looking for evidence of compliance.

Sorry, did I miss something ? That is how I have audited for years !!
 

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