CAPA (Corrective Action and Preventive Action) refers to a systematic management approach for identifying, analyzing, and sustainably resolving quality deviations in manufacturing processes. This two-tiered system combines reactive corrective measures with proactive error prevention.
The Corrective Action process focuses on systematically addressing identified quality deviations. At its core is Root Cause Analysis (RCA), which uses structured problem analysis to pinpoint the underlying causes of deviations.
A systematic correction process involves multiple phases:
Implementation begins with immediate actions to contain errors. This is followed by an in-depth root cause analysis using established RCA methods. The resulting corrective measures undergo a systematic effectiveness review after implementation.
The preventive component of the CAPA system aims to systematically avoid potential quality deviations. Central to this is the integration of the FMEA methodology (Failure Mode and Effects Analysis) for structured risk assessment.
Core elements of prevention:
Modern CAPA implementations leverage digital technologies to boost efficiency. Cloud-based CAPA platforms enable centralized management of all quality-related processes. Integrated workflow management systems support this through:
Successful CAPA implementation relies on clearly defined structures and responsibilities. Measurable objectives and systematic tracking of all measures are critical.
An effective CAPA system thus links reactive error management with proactive quality assurance, forming the foundation for continuous process improvement in manufacturing.