Corrective Action Preventive Action (CAPA)

Quality leader in every industry agrees that 60-80% of all issues are repeat issues and a large portion of the cost of poor quality. With the cost of poor quality identified as 20-30% of revenue in many industries, this is a huge impact on the bottom line.

That naturally leads to consideration of corrective action processes. However, it's long been known that corrective actions against poorly understood systems can lead to more variation rather than less, and no net reduction of repeat issues.

The solution to this predicament is a Quality Risk Management approach to corrective action, ensuring that issues, root cause analysis, corrective action, and quality planning updates for both manufacturing and design, are all linked together in a seamless, enterprise, closed-loop continuous improvement process.

In a Quality Risk Management (QRM) approach, the corrective action challenge is ultimately a quality knowledge management challenge. Corrective actions are viewed as a correction against the quality plan and the understanding of the product and process characteristics being controlled.

Repeat issues are avoided due to deep understanding of continuous improvement of your products and processes. Design FMEAs, design verification plans, process FMEAs, control plans, gage plans and their associated critical characteristics, best practices and lessons learned are the knowledge base that ensure issues don't occur again in the future - that continuous improvement is sustained.