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  Method other than internal auditing

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Author Topic:   Method other than internal auditing
posted 07 June 2000 05:15 AM           Edit/Delete Message   Reply w/Quote
In our certification audit report I found a remark: "A method, other than internal auditing, to ensure that a procedure is effectively implemented either a new or modified procedure is not taken into consideration."

Do you know this kind of methods or this is only a statement from auditor.

Good luck,


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John C
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From:Cork City, Ireland
Registered: Nov 98

posted 07 June 2000 03:26 PM     Click Here to See the Profile for John C   Click Here to Email John C     Edit/Delete Message   Reply w/Quote
The wording seems incomplete but that is often the case when auditors read from notes made on the spot. It is clear to them at the time.
My best guess at this would be that this is not a write up of an n/c finding but a recommendation regards a potential weakness. It seems that the auditor had some reason to believe that a procedure being released could, or has been, overlooked by people who need to know. The only way of catching the error could be by finding the problem during an audit.
When a procedure is changed or released, it is necessary to inform everyone who needs to know and take action. For reasons of economy, the group responsible for document control, hive off this responsibility to people changing or releasing procedures but that person's knowledge of the system or committment is not sufficient to ensure it is done properly.
The solution can be complex and difficult or expensive and time consuming. The group responsible can be motivated if they are held answerable for the failure of the existing method and they should make sure it happens either by doing it themselves or by ensuring a reliable method is devised and that all concerned are fuly trained and committed to follow it.
rgds, John C

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David Mullins
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From:Adelaide, South Australia, Australia
Registered: Nov 1999

posted 13 June 2000 09:43 PM     Click Here to See the Profile for David Mullins   Click Here to Email David Mullins     Edit/Delete Message   Reply w/Quote
This gets back to my question elsewhere on the forum that almost nobody is willing to tackle:
What is an economical and efficient means for creating evidence that staff are aware of new/revised procedures and have read and understood them? (in a non-electronic system, without creating a mountain of records)


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Marc Smith
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From:West Chester, OH, USA

posted 14 June 2000 01:18 AM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
I don't know why you cannot use internal audits as evidence.
"A method, other than internal auditing, to ensure that a procedure is effectively implemented either a new or modified procedure is not taken into consideration."
You have a defined system is how. Your system has to define the process of initiating new procedures and how to change a procedure. The system has to address issues such as distribution and, where appropriate, training. Each company is different as are different type of procedures (by procedures I also encompass documents such as work instructions, etc.) in a company. Change the Scrap procedure (assuming a global procedure) and a lot of people have to be informed in some way.

This can be taken to extremes. In a wafer fab tests are given, shift change meetings are utilized, etc. In an basic assembly shop there are seldom tests and often no shift meetings. But - if your system is designed well (and works well) you can find plenty of evidence that you comply.

How do I know operators are using the most recent issue? You use a defined system which ensures removal of obsolete documents. I see no reason why you can't verify that the system is effective through internal audits, however. How do I know if a procedure was effectively implemented? What type of procedure are we talking about... If you implement a specific work instruction you can cite scrap resulting from operator error, as an example. If there are high scrap levels which can be traced to operator error and the error is determined to be the result of using an obsolete work instruction, your document update system may be broken (or they may have hidden cheat sheets which is another issue).

The point is, you have to look at your over all systems and consider outputs. You have to use some common sense here. You can't test everyone on every procedural change. Nor can you follow up on every procedural change to 'ensure' it is 'effectively' implemented.

And I sure would like other comments on my thoughts. I'm not very good with words.

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Andy Bassett
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Posts: 274
From:Donegal Ireland
Registered: Jun 1999

posted 14 June 2000 05:46 AM     Click Here to See the Profile for Andy Bassett   Click Here to Email Andy Bassett     Edit/Delete Message   Reply w/Quote
Hello David

I have read your post on other threads, and something else has just come to mind, althoug it is not any easy system maybe it helps. After having spent much time setting up a procedure to train employees in new or changed procedures i have noticed that understanding/remembering is very poor.

In addition to having the process owner (instead of me) do the training i now also include a 'understanding check' where the employees are asked specific questions to ensure that they have understood the content. This does seem to have improved the 'absorption of the content' but unfortunately does involve some extra work to set up the 'understanding checks'


Andy B

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Kevin Mader
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From:Seymour, CT USA
Registered: Nov 98

posted 14 June 2000 05:35 PM     Click Here to See the Profile for Kevin Mader   Click Here to Email Kevin Mader     Edit/Delete Message   Reply w/Quote
I agree with Marc. PDCA at work. Auditing is the checking function. If folks aren't reading or understanding what they read, it should be evident.



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