How should we handle a ‘deviation’ (Deviation) if one occurs during day-to-day operations?

A “deviation” is any event in which approved instructions or an established Standard Operating Procedure (SOP) is not followed. All deviations, whether planned or accidental, must be formally managed and addressed. The correct procedure is: 1. Report and record immediately: any employee who identifies a deviation is responsible for reporting it promptly to their supervisor and the quality department. A deviation report must be created immediately, detailing when and where the event occurred, the personnel and materials involved, and how the SOP was not followed. 2. Assess the impact: the quality department must promptly assess the potential impact of the deviation on product quality, safety and efficacy. If the impact is serious, the relevant batches may need to be quarantined and release suspended. 3. Investigate the root cause: investigate the cause thoroughly, rather than stopping at “human error”. Examine whether the process was poorly designed, training was inadequate or there was an equipment problem. 4. Establish CAPA: develop and implement effective corrective and preventive action (CAPA) based on the root cause. 5. Close the deviation: after the investigation and corrective actions are complete, the quality department reviews and formally closes the deviation report.