Re: ISO Document Control

["Peter Neilson" <neilson -at- windstream -dot- net>]

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: