Understanding CAPA by James Bullock, PMP, ASQ CMQ/OE, CSSGB

Understanding CAPA

Corrective Action Preventive Action or CAPA is utilized in continuous improvement to provide actions needed to correct, eliminate recurrence, and prevent poor quality. CAPA’s are changes connected with change control, risk management, and continuous improvement.

The difference between a corrective and preventive action can be misunderstood as well as the difference between a correction and a corrective action. The defined scope of CAPA provides further clarification:

• A correction is an immediate one-time action to fix a non-conformity. This can be classified as rework or a repair having little risk or impact which is typically completed informally.
• A corrective action is an action taken to eliminate or reduce the cause and recurrence of a nonconformity or other undesirable event which poses greater risk and is formally completed (there is action taken after there is a failure).
• Preventive actions eliminate or reduce a nonconformity or undesirable event by averting their occurrence (A failed event has not occurred yet, but there are actions taken to stop a failure or nonconformity from happening). Preventive action(s) can result from an effective corrective action or through continuous risk identification during any stage where changes are made as applicable to processes, systems, etc., to eliminate, avoid, or reduce the occurrence of issues leading to poor quality.

As a CAPA system collects information and develops, it should advance from less corrective to more preventive actions. It is good practice to standardize preventive actions as applicable across other processes, procedures, and systems resulting from corrective actions and risk management. In the long haul, preventing the right risks instead of correcting issues as they occur saves more time, money, and customer relationships as there is less rework. CAPA systems are effective when they are perceived and utilized as a proactive system rather than a reactive one. A risk-based approach emphasizes effective planning and risk management for providing important monitoring, control, and action to identify, evaluate, and prioritize the most critical issues in preventing them. As more data becomes available, it is more important to evaluate and improve the risk management system for it to continue to be effective and reliable.  

CAPAs are an integral part of change, continuous improvement, and risk management. Changes are evaluated and prioritized based on risk, are implemented once tested and approved, and monitored for effectiveness. If additional improvements are identified, then the process starts over which is consistent with the Plan, Do, Check/Study, Act continuous improvement cycle. CAPAs need to be uniquely identifiable to ensure traceability and easy retrieval for audits, research, and their management. It is necessary to classify actions as corrective or preventive to make comparisons between prevention versus correction and to evaluate how the system is utilized. This can provide valuable feedback to determine if the system is used proactively or reactively.

An effective CAPA system sufficiently investigates and identifies true root causes, implements corrective actions for the root causes, utilizes preventive actions to improve and standardize where applicable, properly implements and monitors actions/changes for effectiveness, and provides transparency for completion of all steps. They should not only be applied to products but also processes and systems as well. They are systems that rely on internal and external feedback. If internal and external systems are not integrated adequately and standardized to communicate information consistently, then the system can become less effective. 

Author: James Bullock, PMP, ASQ CMQ/OE, CSSGB

www.gmpviolations.com GMP News, GMP guidelines, GMP Violations, GMP warnings, GMP Trends. A Public Health Global News Portal (This story has not been edited by GMP Violations staff and is auto-generated from a syndicated feed.) Disclaimer: The Logos/Images posted here are belongs to respective to Authority / owners of firm.