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RE: Deviation Management
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Dear Ambika, Ideally your BMR should include list of all instruments which are to be used for processing. This list would be based on the suitability of your equipments for a given process/step. The suitability is generally verified during PQ (performance qualification) too. When an instrument malfunctions, there are two options: 1. You continue using it, if you feel that the malfunction is not affecting the process (e.g. when an additional temperature display of fermentor goes down). 2. You use a similar but different instrument If you don’t file a deviation, where will you record the rational and risk of either of the selections? Also, two instruments which seem to be same may have very high internal variations which are many times not very obvious to users. If there is no deviation recorded, how will some one investigate if some failure happens, whether that was due to instrument or not? Thus deviations are desirable as it shall give you enough room to think all risks associated with any change or malfunction. Also, as it shall require persons from different departments, which shall increase the chances that other aspects of change or malfunction which a used has not thought of, comes into someones mind. Thanks, Arvind |
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