Production Equipment Forms - Case study with ISO 9001:2008

[AndyN]

The comment is made the "forms are identical" - so to my way of thinking, this could mean the actual "layout" of the form is the same - the dates clearly aren't - but we don't know if the information contained therein is identical, hence my comments.

Once upon a time, auditor course exams gave the option for the student to answer what they would do, instead of simply reporting a very basic non-conformity, which lets them describe - as an auditor - what further information they could seek. This allows the examiner to also see competency on the student's part

As with trying to answer any student's cry for help with these types of questions, just confirming a simple answer "Yes, it's a non-conformity to 4.2.3" or whatever, delays their opportunity to learn, IMHO. So, we can help answer the question or we can help them develop a better understanding of the role of an auditor. I'll always go for the second option.

 

[Marc]

<snip> So, we can help answer the question or we can help them develop a better understanding of the role of an auditor. I'll always go for the second option.

I think both aspects are important and they are not mutually exclusive. We can help answer the question and we can help them develop a better understanding of the role of an auditor.

I know there are those here who do not like to answer student questions. As I have said before, those here who do not like to answer student questions should move on and not post in a thread where a student is asking a question.

There are people who come here who are working people who ask very similar questions. They may not technically be school students, but our mission here is to help whether the person is in school or is learning on the job. We do turn people away or treat them differently because they are school students.

 

[Randy Lefferts]

The comment is made the "forms are identical" - so to my way of thinking, this could mean the actual "layout" of the form is the same - the dates clearly aren't - but we don't know if the information contained therein is identical, hence my comments.

It seems to me that if we question everything someone says we end up clouding the issue and discussing things that aren't relevant to the case at hand. Don't get me wrong, sometimes things need questioning. However, if someone says something like "the forms are identical" why would I try to read into that? Simply answering the question based on the information given (forms being identical) would be an acceptable reply, in my opinion.

As with trying to answer any student's cry for help with these types of questions, just confirming a simple answer "Yes, it's a non-conformity to 4.2.3" or whatever, delays their opportunity to learn, IMHO. So, we can help answer the question or we can help them develop a better understanding of the role of an auditor. I'll always go for the second option.

It may sound silly but I would venture there are those that don't come here to learn, they come for an answer. Sometimes providing that answer will help them learn. You asked him/her twice for information and he/she responded twice about traceability. He/she was going down a path that wasn't really relevant to the question at hand. Giving the answer with a bit of an explanation would help them understand it better than continuing to try to get them to answer it.

 

[AndyN]

Randy, I don't disagree with you. I would however say that it's possibly a matter of audit technique. I have been told (plenty of times) that something is one way, only to do the 'show me' and find something else! All I was proposing is that the "form" might look identical, but the process information (which is more important than what it's written on) should be taken into consideration, that's all.

But I won't push the point any further.

 

[Randy Lefferts]

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

Solar,

Corrective action is not part of an auditors job. An auditor audits and documents evidence of the qms. When he finds evidence that something doesn't conform he issues a finding. The company takes the finding and will determine the corrective action. There isn't a "one size fits all" answer. Your corrective action will depend on why the nonconformance occurred in the first place. You would need to provide more detail as to why the document control system allowed an obsolete document to exist in order to determine the corrective action needed.

 

[solarcon5]

During the inspection 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?.

Ok, we told that it is 4.2.3.

So please can you help me with this ?.

Trying to explore in depth the previous stunt, the investigation team for compliance with ISO 9001:2008 has been found the following:

During the inspection of the file of the Department of Production, the ?inspection team? has been found that the production form in some cases approved by the Director of Production, in other cases approved by the Director of Department, in other cases approved by the foreman and while in other cases there is no approval at all.

Is this confirmation or not according to ISO 9001:2008? And if it is, what paragraph is? HELP ME PLEASE !!!!

 

[solarcon5]

is it 4.2.3 c) ?

 

[Randy Lefferts]

During the inspection 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?.

Ok, we told that it is 4.2.3.

So please can you help me with this ?.

Trying to explore in depth the previous stunt, the investigation team for compliance with ISO 9001:2008 has been found the following:

During the inspection of the file of the Department of Production, the ?inspection team? has been found that the production form in some cases approved by the Director of Production, in other cases approved by the Director of Department, in other cases approved by the foreman and while in other cases there is no approval at all.

Is this confirmation or not according to ISO 9001:2008? And if it is, what paragraph is? HELP ME PLEASE !!!!

Check 4.2.3 a and b.

 

[solarcon5]

ok sir. So the problem is that there is no planning for a "review cycle" into company?s document development procedure who can help document authors improve the quality of the resulting documentation ?

Circulating the document for review can include future users of the document, managers responsible for the activity, workers in areas affected by the activity and other interested individuals

 

[solarcon5]

All documents must be reviewed periodically and updated and re-approved if needed. This review can be tied to a company's internal audit process, management review or scheduled on some periodic (annual?) basis. A record of such reviews must be kept.