Production Equipment Forms - Case study with ISO 9001:2008

[Marc]

<snip> It is also assumed that what you mean by "data encoding" is actually the revision level.

This is the key question.

 

[Randy Lefferts]

This is the key question.

Yes. I wasn't sure whether it was revision level or if he was referring to the data captured on the form or something entirely different. I am leaning toward revision level but will have to wait to see a response to it.

 

[AndyN]

And we don't know the forms are identical. They could be running a different (earlier) spec product to meet a customer's specific requirement (material composition) where the other machine might be running the latest (which isn't for that specific customer). We don't know what the effect of the changes in the document are, either! The key parameters/ingredients etc might be the same!

Either a badly written case study or a silly, easy document control non-conformity, but not letting the auditor ask why! A classic case of teaching simple conformity rather than effectiveness!

 

[Randy Lefferts]

And we don't know the forms are identical. They could be running a different (earlier) spec product to meet a customer's specific requirement (material composition) where the other machine might be running the latest (which isn't for that specific customer). We don't know what the effect of the changes in the document are, either! The key parameters/ingredients etc might be the same!

Either a badly written case study or a silly, easy document control non-conformity, but not letting the auditor ask why! A classic case of teaching simple conformity rather than effectiveness!

Actually, he states they are identical. I was just responding to what he stated.

<snip>of Department of Production, it appeared that two ?Extruder? used the same (identical) production form but with different data encoding. In the ?Extruder? 1 production form brought encoding E-QA-7.5.1 -3, version 2 from 01/01/2012 and the Extruder 2 form production brought encoding E-QA-7.5.1 -3, version 1 since 01/06/2009?.

 

[solarcon5]

ok i think is [FONT=&quot]4.2.3. THANK YOU ALL !!! and what should i do for corective action ?[/FONT]

 

[Sidney Vianna]

And we don't know the forms are identical.

Yes, we do.

During the inspection of Department of Production, it appeared that two ?Extruder? used the same (identical) production form but with different data encoding

Either a badly written case study or a silly, easy document control non-conformity, but not letting the auditor ask why! A classic case of teaching simple conformity rather than effectiveness!

This is very likely a case of an auditor test with the additional challenge of being translated in English by someone who does not have English as the native language. As Marc said numerous times in this type of situations, if one does not want to help the people who asked the question, stay out of the thread. But to call it silly does not help anyone.

 

[solarcon5]

And we don't know the forms are identical. They could be running a different (earlier) spec product to meet a customer's specific requirement (material composition) where the other machine might be running the latest (which isn't for that specific customer). We don't know what the effect of the changes in the document are, either! The key parameters/ingredients etc might be the same!

Either a badly written case study or a silly, easy document control non-conformity, but not letting the auditor ask why! A classic case of teaching simple conformity rather than effectiveness!

++++++++++++++++++++++++++++++++++1

I totally agree!!!

 

[AndyN]

Yes, we do.

This is very likely a case of an auditor test with the additional challenge of being translated in English by someone who does not have English as the native language. As Marc said numerous times in this type of situations, if one does not want to help the people who asked the question, stay out of the thread. But to call it silly does not help anyone.

You have long campaigned for auditors to be taught to evaluate effectiveness, I thought. Surely, a "silly" document control issue is what it is, since the auditor is not (apparently) being asked to dig deeper to discover what the effect on out put is...

 

[Sidney Vianna]

You have long campaigned for auditors to be taught to evaluate effectiveness, I thought. Surely, a "silly" document control issue is what it is, since the auditor is not (apparently) being asked to dig deeper to discover what the effect on out put is...

I have always (and will continue to) advocated that, in the real world, and as required by the standards, assessment of effectiveness needs to be done IN ADDITION to assessment of conformity. They are not mutually exclusive.

Not every question posed in this Forum should lead to high level discussions, in my opinion.

This thread, as far as I can tell, relates to an auditing exam, with a very simple scenario to be evaluated; very likely, a beginner's test. The translation makes it for an additional challenge. To delve into effectiveness of the academic scenario, going beyond the original request seems an overkill to me.

Sometimes, we throw a fish, rather than teaching how to fish. It is a judgement call.

 

[Marc]

Actually, he states they are identical. I was just responding to what he stated.

Yup - That is what confused me and why I replied as I did in this thread.