Re: ISO Document Control

Subject: Re: ISO Document Control
From: Sally Derrick <sjd1201 -at- gmail -dot- com>
To: Peter Neilson <neilson -at- windstream -dot- net>
Date: Fri, 28 Oct 2011 10:56:46 -0500

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

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