Deviations are defined as any measurable differences between an observed value and an expected or ‘normal’ value for a process or product condition, or a departure from a documented standard or procedure. The point at which such a departure from the norm becomes a true deviation must be defined. For example, exceeding a set threshold or limit may be recorded as a deviation. Sometimes, deviation permits can be issued.
In the life sciences, a deviation can arise at any point during a product’s lifecycle - from the testing phase to manufacturing to final product acceptance to post-market surveillance. For example, a deviation can be triggered by a customer complaint when a company’s standards don’t meet certain certification requirements.
For continuous improvement and GMP compliance, any deviation from set procedures must be documented. FDA CFR 211.192 / 21 CFR Part 11 obligates a detailed investigation into any deviation, including documentation of conclusions and follow-up actions. Incidents that may affect quality or reliability of records or tests should also be investigated and resolved.
A good eQMS usually has a system inbuilt to detect and record deviations. Deviations can be prevented through frequent data reviews and controls; an upward trending data set that’s heading for the defined deviation threshold can indicate a future deviation, and can be stopped through the appropriate CAPAs.
Related links:
