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

From: "Schmidt-Nebril, Kathleen" <kschmidtnebril**At_Symbol_Here**>
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


From: "Tsiakals, Nicholas John" <tsiakals**At_Symbol_Here**>
< 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

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!

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