Date: Thu, 26 Aug 2010 19:42:58 +0000
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: "Peifer, Patricia" <Patricia.Peifer**At_Symbol_Here**WESTPHARMA.COM>
Subject: Hoods failing annual calibration

I work in a GMP laboratory in the medical device ind ustry.  A member of our metrology team questioned me today as to what we would do in event one of our chemical fume hoods did not meet one or mor e of its annual qualification events, for example if the hood did not meet its face velocity requirement during the annual test.  We do have monitors on our hoods, but occasionally they have been found to be faulty.

According to our work instructions, any “instr ument” which does not meet any of its qualification events must have an impact assessment done.  Usually this relates to the impact the fai lure may have had on the results of tests that were done using the instrument.  But in this case we would be talking abou t a safety impact assessment rather than focusing on the results of tests.& nbsp; The metrology member also mentioned to me that we should, according t o our work instruction, have a usage log for each hood so that a proper impact assessment could be done. 

My thoughts are this:

I would not call a chemical fume hood an “inst rument” and therefore would not consider it subject to the previously mentioned work instruction

I have never heard of any facility having a usage lo gbook for chemical fume hoods

BUT… the question I really want to ask the gro up is this:  in the event a hood fails any of its annual calibration e vents, what do you do?   Do you speak to people who have been usi ng the hood, prepare an impact assessment, etc.?


Pat Peifer

Health, Safety and Training Team Leader

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