Gordon J. Kroemer, CSP, NRCC-CHO
Director, Office of EHS
900 SE Baker Street, A508
McMinnville, OR 97128
On 26/08/10 12:42, "Peifer, Patricia" <Patricia.Peifer**At_Symbol_Here**WESTPHARMA.COM> wrote:
< SPAN STYLE='font-size:11pt'>I work in a GMP laboratory in the medical device industry. A member of our metrology team questioned me today as to wh at we would do in event one of our chemical fume hoods did not meet one or m ore of its annual qualification events, for example if the hood did not meet its face velocity requirement during the annual test. We do have moni tors on our hoods, but occasionally they have been found to be faulty.
According to our work instructions, any “instrument” which does not meet any of its qualification events must have an impact assessment don e. Usually this relates to the impact the failure may have had on the results of tests that were done using the instrument. But in this case we would be talking about a safety impact assessment rather than focusing o n the results of tests. The metrology member also mentioned to me that we should, according to our work instruction, have a usage log for each hoo d so that a proper impact assessment could be done.
My thoughts are this:
I would not call a chemical fume hood an “instrument” and there fore would not consider it subject to the previously mentioned work instruct ion
I have never heard of any facility having a usage logbook for chemical fume hoods
BUT… the question I really want to ask the group is this: in th e event a hood fails any of its annual calibration events, what do you do? & nbsp; Do you speak to people who have been using the hood, prepare an i mpact assessment, etc.?
Health, Safety and Training Team Leader
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