Microbial data deviations occur when the results of microbial tests fall outside of the product specifications or acceptance criteria. These deviations are also known as “out-of-specification” or “out-of-limit” results. The purpose of a microbiological data deviation investigation ...

Out of specification investigation flowchart for laboratory stage as well as manufacturing.

A recent report by the US Food and Drug Administration (FDA) showed an increase in investigations of off-specification products in the pharmaceutical industry. The FDA cites deterioration in quality control as a major cause of these problems. As the industry transitions to novel and more complex products, ...

A. Deviations happen. FDA recognizes this and requires deviations to be investigated and documented. Thorough and timely deviation investigations are critically important. Typically, deviation investigations should be led by the Quality Unit and conducted in collaboration with the operational department ...

A fault tree is an investigation tool that can identify and resolve system or process faults. It is also helpful in finding the root cause of any incident. An organization or company may have multiple fault trees based on defects, errors or problems. Just as a fishbone tool has a fishbone structure, ...