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Author Topic:   Hard Copies from Electronic Media
Marc Smith
Cheech Wizard

Posts: 4119
From:West Chester, OH, USA
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posted 21 November 1999 06:32 AM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
I particularly liked this 'rant':

-----snippo-----

Subject: Re: Use of "electronic" doc /../Hankwitz/Summerfield/Pfrang
Date: Fri, 5 Nov 1999 14:48:38 -0600
From: Moderator

From: pfrang@nicolet.com (Doug Pfrang)

>From: George Summerfield
>
>Gary:
>
>If your master copy of the document resides on a LAN system, but someone
>needs to print it to take to their workstation, then you have a document
>control problem that must be addressed. On the other hand, you can have it
>stipulated that ANY printed material in your work area is automatically
>considered an 'uncontrolled' document; but that just isn't practical in
>most applications.

I completely disagree that printing a paper copy of an electronic original document automatically creates a "document control problem."

I can prove this by reciting each of the Standard's document control requirements and demonstrating how a printed paper copy meets every requirement:

1. Section 4.5.2 requires: "The documents...shall be reviewed and approved for adequacy by authorized personnel prior to use."

My response: As long as the electronic master is reviewed and approved for adequacy by authorized personnel prior to use, then a printed paper copy of that master is a perfectly valid document. The Standard does not require the paper copies to receive a separate review and approval; however, if you want to cover this possibility, then simply designate the people who make paper copies as "authorized personnel" and have them "review and approve" the paper copy (i.e., confirm that it matches the electronic master) prior to use.

2. Section 4.5.2 also requires: "A master list...identifying the current revision status of documents shall be established and be readily available...."

My response: This language is about the master list, not about the control of the document, so it is not relevant to this proof.

3. Section 4.5.2(a) requires the control procedures to ensure that appropriate documents are available where they are needed.

My response: Paper copies actually help ensure that appropriate documents are available where needed.

4. Section 4.5.2(b) requires the control procedures to ensure that invalid and/or obsolete documents are removed or otherwise not incorrectly used.

My response: Paper copies whose revision level matches the revision level of the electronic master are valid.

5. Section 4.5.2(c) requires that obsolete documents are suitably identified.

My response: Paper copies whose revision level does not match the revision level of the electronic master can easily be identified as obsolete.

6. Section 4.5.3 requires that "Changes...shall be reviewed and approved by the same functions/organizations that performed the original review and approval...."

My response: See my response in number 1 above. As long as the same methods are used to review and approve document changes, this requirement will be satisfied.

Now, I challenge you to cite the specific requirement of the Standard that is violated by printing a paper copy of an electronic original document.

I am sorry if I seem contentious, but I have seen far too many people wrongly assert that something is an ISO violation because they never cite any specific requirement of the Standard that is violated.

>Another way to acquire a document control problem with electronic media is
>to advertise that everything is available for viewing on a web page. But,
>the web master may not be the writer (process owner) of each document.
>John Doe, who has access to his documentation, pulls down his document and
>revises it, then sends you (web master) a copy of the revised edition to
>post to the web page. Unfortunately, you're up to your eyeballs in other
>IT problems and the revision is not posted for a couple of weeks. His
>people are no longer using the proper document, and this could have serious
>repercussions; dependant upon how important that process/procedure document is.
>In short, you have to address how you maintain document control; just like
>it stipulates is 4.5 of the compendium. Whether the document is hard
>(paper) or soft (electronic), it must be controlled. Controlling the
>master copy alone is easy. Most companies have big problems controlling
>the numerous copies of that master copy. Can you decide not to address
>that; no!
>
>George

Frankly, I don't know of any company that has "big problems" controlling the numerous copies of their master documents. They simply put a version number (or a date, which can be equivalent to a version number) on each document, and then as long as the person using the document checks to make sure he or she is using the correct version, there is no problem. Again, like I said above, I challenge you to cite the specific language from the Standard that is violated.

-- Doug

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barb butrym
Forum Contributor

Posts: 637
From:South Central Massachusetts
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posted 21 November 1999 10:06 AM     Click Here to See the Profile for barb butrym   Click Here to Email barb butrym     Edit/Delete Message   Reply w/Quote
its simply a matter of discipline and ones own document control procedure. and what is and is not allowed....typically the way it happens is someone is caught using an out dated revision to work on product, then its an issue.

Probably, whoever offered the scenario, left out the details (as so many of us tend to do?)....and its not an ISO issue, but a potential for one ....therefore the generalized statement may have been taken out of context.... It does leave you wide open/vulnerable...and it does lead an auditor to the "what happens if...questions" So as a consultant many try to eliminate the potential problematic scenarios. Then in reverse as a consultant turned auditor, many cannot completely remove the hat, and force their views into the standard. The answer lies in the evidence....was there any evidence to show lack of control or non-adherence to procedure?

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