deviationsmanagement

Deviationsmanagement, also known as deviation management, is a systematic process used in various industries, particularly in regulated fields like pharmaceuticals, medical devices, and manufacturing, to identify, document, investigate, and resolve any instance where a product, process, or system does not conform to established specifications, procedures, or expected outcomes. The primary goal of deviationsmanagement is to ensure product quality, safety, and compliance with regulatory requirements.

The process typically begins with the identification of a deviation, which can occur during production, quality control testing, or even through customer complaints. Once identified, the deviation must be formally documented, capturing details such as the nature of the deviation, the affected product or process, the date and time of occurrence, and the personnel involved. Following documentation, a thorough investigation is conducted to determine the root cause of the deviation. This investigation is critical for understanding why the deviation occurred and for preventing its recurrence.

Based on the root cause analysis, corrective and preventive actions (CAPAs) are developed and implemented. Corrective actions aim to fix the immediate problem, while preventive actions are designed to eliminate the possibility of the deviation happening again. The effectiveness of these CAPAs is then monitored and verified. Throughout the entire deviationsmanagement process, rigorous record-keeping is essential, as these records are often subject to regulatory audits and inspections. Effective deviationsmanagement is a cornerstone of quality assurance and risk management.