Re: ISO Document Control

[Scott Turner <quills -at- airmail -dot- net>]

ISO 9001 does't tell you how you are supposed to do that stuff only that you need a consistent system. 

It is not a requirement of 9001, it does appear to be a require mention of your customer. 

There is a difference. You are operating under two separate requirements.

On Oct 28, 2011, at 10:56, 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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