Date: Thu, 26 Aug 2010 20:25:35 -0400
Reply-To: DCHAS-L Discussion List <DCHAS-L**At_Symbol_Here**LIST.UVM.EDU>
Sender: DCHAS-L Discussion List <DCHAS-L**At_Symbol_Here**LIST.UVM.EDU>
From: List Moderator <ecgrants**At_Symbol_Here**UVM.EDU>
Subject: Re: Hoods failing annual calibration
Date: August 26, 2010 5:26:28 PM EDT
Subject: RE: [DCHAS-L] Hoods failing annual
calibration
The hoods that
fail to meet the minimum flow are tagged "Out of Use" and our physical
plant calls in for service to them. Once they have been
recalibrated to proper flow they are then placed back in
service.
Kathleen Schmidt-Nebril, NRCC-CHO
Chemistry Division Department of Natural
Science
Dominican
University
River Forest, IL
60305
708-524-6533
===
<
div style="margin-top: 0px; margin-right: 0px; margin-bottom: 0px;
margin-left: 0px; font: normal normal normal 12px/normal Helvetica;
min-height: 14px; ">Date: August 26, 2010 5:36:13 PM EDT
Subject: RE: Hoods failing annual
calibration
Pat,
What would be the value of an
impact assessment upon discovering an out of spec chemical fume
hood?
I would guess the impact assessment mentioned in the
work instruction is more for Quality Assurance purposes, meaning the
scope is more properly the processes and products affected by the
nonconformance. Even so, it could be valuable to run a safety
impact assessment - minimally it could build credibility for the
safety program. =93A protective device was down for X period of
time - what problem did that introduce? If none, do we need the
protective device? Why / Why not?=94 Be sure you have firm
answers!
Real quickly, in a GMP lab, if you have a work
instruction you are not following (usage logs for hoods), you either
want to start following it or modify the work instruction. A sharp
auditor would start poking hard to find other work instructions you are
not following.
As for what to do, I think many organizations have a
policy along the lines of, =93Repair immediately upon discovery of out
of spec performance - here are the ways we check to ensure proper
performance.=94 I think it=92s smart to also add, =93Evaluate
impact of out of spec performance,=94 but that is probably not in most
policies.
Hope that helps!
-Nick
