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RE: Deviation Management
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Why do we document any deviations? To determine that our process is under control. To seek to improve the process and its control. To give confidence (by investigation at an appropriate level) that the final product was not jeopardised. If you only do it because it is "required" you have not understood the concept of GMP. Documentation is the start of the investigation. (not the appropriate probe, somebody damaged it, short active life, faulty on installation, etc) Identifying what went wrong allows corrective action so it will not go wrong again. If a deviation is repeated then a more thorough investigation is required (because the deviation becomes more serious).. Owen |
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