Now that the type and extent of the deviation has been determined the event needs to be investigated. In both type of deviations the investigation for the real reason for the error needs to be determined, that is, the root cause.6 The FDA looks at the investigation very carefully.7 It is not sufficient to say that the operator, or analyst in the laboratory made the error. The root cause for the error needs to be established. If, after careful review of relevant facts there is no “root cause” apparent then the next best is the most likely cause. In performing an investigation8 the following need to be considered:
The Investigation5
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