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Re: ISO Document Control

Subject: Re: ISO Document Control
From: "Peter Neilson" <neilson -at- windstream -dot- net>
To: "Sally Derrick" <sjd1201 -at- gmail -dot- com>
Date: Fri, 28 Oct 2011 12:38:50 -0400

She says, "Welcome to bureaucracy." She reminds me to tell you about the inspector who put us out of part of our business by inventing an interpretation of USDA regulations that would require us to spend over $100,000 on improvements to maintain an operation that was adding a gross of $3000 per year. There was no feasible way to fight, and the inspector (who had a personal agenda in the area of aminal rghits) knew that.

A sign at the local electrical supply company says, "Arguing with the inspector is like wrestling with a pig in the mud. After a while you come to the realization that the pig enjoys it."

You are supposed to second-guess the auditor, and guess correctly. That's why I mentioned creative paranoia.

Often it seems that the major purpose of any bureaucracy is to maintain the bureaucracy. That alone is a reason to avoid bureaucracy.

On Fri, 28 Oct 2011 11:56:46 -0400, Sally Derrick <sjd1201 -at- gmail -dot- com> wrote:

Thanks, Peter. Regarding audit type #1, what does your wife do when the
auditor is "requesting" something that is not required? For example, in my
brand new, shiny copy of ISO 9001, Section 4.2.3 Document Control has not
one word about approval signatures, effective dates, or retention periods.
However, the customer's internal auditor docked me a point for not having
it. I have pushed back on it and am waiting to hear their response. I
worry about the difference between interpretations on this stuff, and the
ever-present 'but we've always done it this way' mentality.

Sally


On Fri, Oct 28, 2011 at 10:31 AM, Peter Neilson <neilson -at- windstream -dot- net>wrote:

Here's a report from my wife who maintained this stuff at Gillette's QC
department: To avoid all computer problems, QC kept printed copies of all
the FDA-required manuals, including all the signed revision sheets, under
lock and key. If there was ever any question, THAT was the authoritative
version.

That method avoids problems with partial updates, multiple but
contradictory versions, missing signatures, untestable authentication, and
so forth.

For maintenance of the printed manuals in the various laboratories, the QC
manager (my wife) took the replacement pages into each lab, had the lab
manager sign for the new copy, replaced the pages, took the old pages and
shredded them. That was >copies< that got shredded. The originals of the old
pages were archived.

A paper-intensive system such as this just cries out for computerization,
doesn't it?

Possibly. But everything Gene says is on target. Modestly endowed (or
home-grown) documentation management software will get you in trouble later.
In the FDA environment the manuals are legal documents, and their loss
leaves the QC manager open for legal action. "Would you want," says my wife,
"your home's deed stored only on some computer somewhere?"

There are two styles of audits. (1) A genuine auditor actually inspects the
details of your operation, and calls out the aspects that need correction.
Argument with the auditor is futile. (2) A lazy auditor looks to see that
the facility actually exists and that there are computers, and maybe books
that look like manuals on the shelf. He gets taken out to lunch. Argument
with the auditor is totally unnecessary.

You can hope for style 2, but creative paranoia will leave you prepared for
style 1.


On Fri, 28 Oct 2011 10:38:13 -0400, Gene Kim-Eng <techwr -at- genek -dot- com> wrote:

You don't need to automate ANY of the functions of a document control
system. Restricted access and past revision recovery can be accomplished
with a locking file cabinet full of printouts. But if you're going to go to
the trouble and expense of implementing a tool, you want one that provides
all the features even if you don't use them all initially, because if you
ever have to pass other audits, such as one for a federal CFR, the last
thing you want to have to do is go out shopping for another document control
tool because the one you already implemented doesn't provide the ability to
turn on additional controls.

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Follow-Ups:

References:
ISO Document Control: From: Sally Derrick
Re: ISO Document Control: From: Scott Turner
Re: ISO Document Control: From: Keith Hood
Re: ISO Document Control: From: Sally Derrick
Re: ISO Document Control: From: Gene Kim-Eng
Re: ISO Document Control: From: Peter Neilson
Re: ISO Document Control: From: Sally Derrick

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