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Author Topic:   Quality Manual
John C
Contributor
posted 28 June 1999 07:51 AM     Click Here to See the Profile for John C   Click Here to Email John C     Edit/Delete Message
Marc,
Which brings us back to the old 'interpretation' issue; I don't believe in interpretation because 100 people can hold 101 different views on any given day, and 1001 different views over a period of three months. What could be clearer that the last paragraph of the clause; "Where practicable, the nature of the change shall be identified in the document or the appropriate attachments."
One sentence, 17 words. Which words do we disagree about? It doesn't mention 'preference', 'importance', 'type of document', but does give an option, conditional upon filing, on or attached to the document, being impracticable.

I stand by the words and my little pocket dictionary.
rgds, John C

John C
Contributor
posted 28 June 1999 09:49 AM     Click Here to See the Profile for John C   Click Here to Email John C     Edit/Delete Message
Marc,
Which brings us back to the old issue of 'interpretation'; On a given day, 100 people will have 101 different interpretations and 1001 over a 3 month period, which is why I stick to the text. The last paragraph of the clause is quite clear showing that the change information is to be held on, or attached to, the document where practicable. It doesn't say anything about opinion, importance, etc. How can we disagree over 17 simple words? Which word means something to you that is different from the meaning in my little pocket dictionary? I stand by the text.
rgds, John C

John C
Contributor
posted 28 June 1999 10:02 AM     Click Here to See the Profile for John C   Click Here to Email John C     Edit/Delete Message
Sorry, I didn't notice the change to a new page and thought my first response had'nt filed. Now I seem to have lost the edit function.
John C

ALM
Contributor
posted 28 June 1999 10:04 AM     Click Here to See the Profile for ALM   Click Here to Email ALM     Edit/Delete Message
JOHN - MY answer to the question about eliminating the change history and referring to the ECO on file would be a resounding YES. I would not mislead the person who asked the question and I thought that my original response answered the question.

Moving on...

Well, I suppose what it then comes down to is what is defined as "practicable?"

I understand your concerns over the one example I cited for why it is not practicable for me. One cannot legislate or even train-out the curiosity of people.

Now, are the auditor and I going to get into a pissing contest over what is the definition of "practicable?" I think not.

My definitions of "not practicable" include:

1) My favorite and, in my experience, unchallengeable: "It is non-value added. Our current document control system provides for Document Change Orders. The nature of the change is on file with "ALM." Therefore, it is an unnecessary repetition of effort to also take the time to create (a new revision history document within the manuals) or (type the nature of change within the procedure itself), even if it is only a summary of the actual change."

2) "It has been our experience that it creates more questions in the minds of users than it does provide answers or insight. Due to this fact, we removed the "nature of change" from points. Additionally, we review historical data when there arises a time for a potential new revision with all appropriate personnel."

3) "Our quality system wasn't designed to accommodate the nature of changes within the documents and we have provided a more than adequate alternative to cluttering up our manuals with information that will not be used during day-to-day operations WHICH MEETS THE STANDARD."

There are a few. You don't have to like them, but as previously stated, it has never been an issue with our registrars. In each case, it is not practicable in our eyes and does nothing to add value to the documented Quality System.

Additionally, I have always thought that leaving historical information (old, non-current documentation, IMO) flies directly in the face of 4.5.2 (b) >>> "invalid and/or obsolete documents are promptly removed from all points of issue or use, or otherwise assured against unintended use..."

Granted, the documents are removed, then why "where practicable," are we going to put back into the "document or appropriate attachment" information (even summarized) that has been deemed obsolete?

No auditor worth his salt will hold-up my certification over such a non-issue. The PURPOSE behind the specific parts of the Standard that we discuss are most definitely covered. I would defend how we have set this issue up against any auditor who would have a problem with it.

Just another viewpoint...

As for your not agreeing to disagree... that is your prerogative. However, we have been certified for 4 years running with a documented Quality System to ISO 9002 Standards. The way we have set it up must be correct and I understand that there is more than one correct way to do it.

ALM

[This message has been edited by ALM (edited 28 June 1999).]

John C
Contributor
posted 28 June 1999 12:01 PM     Click Here to See the Profile for John C   Click Here to Email John C     Edit/Delete Message
Alm,
Sure, but I'm not engaging in this discussion to find out what you think makes you right, or to prove to you that I am right. I'm testing my own ideas and methods and trying to find out where I am wrong. As soon as you show some evidence then I'll be the first to thank you.
But I'm shutting down now and leaving my present place of employment, so I can't continue the discussion for a few weeks.
Look; If I were in your position I would just say that for various reasons it is not practicable in your case. I don't care what your auditor thinks of it.
But, that's a specific case and you can't answer the initial question, which was general, by showing specific examples. You need to give an answer that covers all cases.
Thanks again
and rgds,
John C

barb butrym
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posted 28 June 1999 02:14 PM     Click Here to See the Profile for barb butrym   Click Here to Email barb butrym     Edit/Delete Message
the document and the point of use as well....if lots of sites use the document and need to train to the new change, then the nature of the change being available is more important than if the document is used primarily by the function that changes it, or it is transparent to the factory.

barb butrym
Contributor
posted 28 June 1999 02:15 PM     Click Here to See the Profile for barb butrym   Click Here to Email barb butrym     Edit/Delete Message
AND to answer the original question....which I guess I missed as well....YES

ALM
Contributor
posted 28 June 1999 03:29 PM     Click Here to See the Profile for ALM   Click Here to Email ALM     Edit/Delete Message
JohnC wrote the items with the "[[[ ]]]" brackets.

[[[Sure, but I'm not engaging in this discussion to find out what you think makes you right, or to prove to you that I am right. I'm testing my own ideas and methods and trying to find out where I am wrong. As soon as you show some evidence then I'll be the first to thank you.]]]

No one needs to thank me. The original poster asked a question and I gave him an answer based upon my experiences.

I didn't realize that this was the direction that the discussion had turned. You are certainly more than welcome to have an opinion about the subject. My reply to the original poster was that my experience with different registrars was that having the nature of the change in the document or as an attachment has not been an issue. Unless I misread his original post, that was the crux of the matter. Could he eliminate the "nature of the change" on the document and simply refer to his ECN records? I say yes.

As for your methods and experiences go, continue as you wish. Short of sending you years of audit results from our registrars, the "proof" that I have offered that I am "right" is continued certification with no majors, minors, or even "opportunities for improvement" where the nature of the change issue is concerned. I think that this is evidence enough.

[[[Look; If I were in your position I would just say that for various reasons it is not practicable in your case. I don't care what your auditor thinks of it. But, that's a specific case and you can't answer the initial question, which was general, by showing specific examples. You need to give an answer that covers all cases.]]]

The answer is YES. He does not NEED to do it. That covers all cases. All someone has to do is show even the slightest evidence that it is not practicable for them and that is the end of the story.

I believe that the original poster wouldn't be asking the question if he thought that the task was "practicable" ---> he cited the redundancy of the task in his original post.

Even using Barb's excellent example of a situation where it might be necessary, in today's technological world (phones, faxes, scanners, networks, etc.) one could still make a case that doing so would not be practicable and that the communication of the historical changes to documentation was handled any number of appropriate ways to meet the requirements of the standard.

It isn't a matter of me "thinking" that I am right, the results speak for themselves. You are the one who made the blanket statement that YOUR opinion was "the best way" and intimated that for the sake of keeping peace with an auditor who will potentially call you on something that is not REQUIRED, one should design their system to accommodate them. You said that he "needs to keep it." That is wrong. If he deems it not practicable, he absolutely does NOT have to keep it. The day the Standards uses the words REQUIRED in the above topic, you simply do not "have to keep it."

Conclusion... all of our interpretations and practices aside, the original question was and still is... "can I eliminate the revision record from the manual itself and keep all changes available for review in my Change Notice files (ECO's)?" The answer to his question is YES, no evidence, interpretations, opinions, experiences necessary. He absolutely can.

ALM

[This message has been edited by ALM (edited 28 June 1999).]

Marc Smith
Da Cheech Wizard
posted 28 June 1999 06:45 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message
John:

Please don't take this as a personal thing. I enjoy your input here and I don't want anyone offended. I offer this in respect to interpretations:

You said

quote:
Which brings us back to the old 'interpretation' issue; I don't believe in interpretation because 100 people can hold 101 different views on any given day, and 1001 different views over a period of three months. What could be clearer that the last paragraph of the clause; "Where practicable, the nature of the change shall be identified in the document or the appropriate attachments.
The words where practicable (we might say appropriate instead) are the gateway to interpretations in this specific scenario.

For the most part I make my living interpreting ISO9000 and QS9000. I tell clients to be prepared for auditors with 'idiot' interpretations. I also tell them they have to understand the intent of each sentence or paragraph to be able to interpret the requirement with respect to their company and their industry.

This whole site is based upon the fact that interpretations are part of the game. If there was no importance in interpretations. I started the site and, as is on the first page of the site

quote:
The Beacon for Direction Thru The ISO9000 - QS9000 Fog and 'Intent' Blurrr-r-r...
This was (and is) based upon the fact that both ISO and QS are vague even when they appear to be precise

In the QS9000 arena, there were, and though they said there would be no more, there are now a few (more to come) interpretations on the latest revision.

John, no offense, but interpretations are what it's all about. It's why people participate in the forums.

-------

Alm, if you want to quote someone, there is a neat, easy way to do this. 'COPY' the text and PASTE it into your response. If you review the 'UBB Code' functions at /ubb/ubbcode.html you will see it is easy to do this

quote:
Alm, if you want to quote someone, there is a neat, easy way to do this. 'COPY' the text from the message and PASTE it into your response.
Obviously you don't have to do this, but it does make the quoted text easy to see. And it's real easy! You can even do lists and stuff. Basically it's 'Easy HTML'.

----------

Anyway, to go back to Mark Smith's original question

quote:
can I eliminate the revision record from the manual itself and keep all changes available for review in my Change Notice files (ECO's)?"
The answer is Yuppers! (Yes). You can keep them any damn place you want. Do consider 'readily available' as an auditor interest.

[This message has been edited by Marc Smith (edited 28 June 1999).]

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