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Subject:Re: Storage of hardcopy reviews? From:"Miller, Alan" <Alan -dot- Miller -at- prometric -dot- com> To:"TECHWR-L" <techwr-l -at- lists -dot- raycomm -dot- com> Date:Wed, 22 May 2002 13:32:13 -0400
Lemme tell ya about Regulatory Concerns. Turns out that the mass of hardcopy documentation required for the construction and operation of a typical nuclear power plant over its 30-year licensed lifetime exceeds the mass of the plant (including structures). And any one of those documents must be available for NRC audit and review. Though only the current year and one past year must be available on site, the rest may be stored on site electronically. Originals must be preserved for the life of the plant plus some (secret) number of years somewhere secure and off site.
Now, where did I put that draft?
Al Miller
"Chief Documentation Curmudgeon"
Prometric, a Thomson Corporation business
Baltimore, MD
A positive attitude may not solve all your problems, but it will annoy enough people to make it worth the effort.
--Herm Albright
-----Original Message-----
From: bounce-techwr-l-40429 -at- lists -dot- raycomm -dot- com@ITP On Behalf Of "Dick Margulis " <margulis -at- mail -dot- fiam -dot- net>
Sent: Wednesday, May 22, 2002 9:44 AM
To: TECHWR-L
Subject: Re: Storage of hardcopy reviews?
In addition to the considerations Geoff elucidates, there are circumstances where there are regulatory concerns. If you work in a regulated industry, there may be specific rules about retention of hardcopy review documents. In the case of the FDA-regulated medical device manufacturing industry, for example, the Quality System Regulation requires that such review markups of any documents that belong to the Design History File be retained until the last device remaining in the field, anywhere in the world, is scrapped. That's a mountain of paper that has to be properly cataloged and indexed when you put a development project to bed, lemme tell ya. (This kind of regulation is Iron Mountain's bread and butter.)
Dick
"Hart, Geoff" <Geoff-H -at- MTL -dot- FERIC -dot- CA> replied to Malkia Payton Jackson:
>
>You can't come up with a good answer to this question until you understand
>why you want to keep these reviews in the first place.
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