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Capability Directory

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Managing and implementing corrective and preventive actions

Managing and implementing corrective and preventive actions


Related Terms:

Managing and implementing corrective and preventive actions (CAPA) is the process of identifying, investigating, and resolving nonconformities, deviations, and other quality issues within an organization. It involves taking corrective action to address existing problems and preventive action to prevent future occurrences.

Beginner competence definition

Beginner-level individuals are able to identify and report quality issues and contribute to the implementation of corrective and preventive actions. They can follow established procedures for CAPA and assist in investigating the root cause of quality issues. They have basic knowledge of quality standards and regulations and understand the importance of CAPA in maintaining quality.

Intermediate competence definition

At an intermediate level, individuals should be able to lead and manage CAPA projects, including identifying nonconformities, determining root causes, developing corrective and preventive actions, and implementing and monitoring these actions. They can establish and maintain a CAPA system, including documentation and record keeping. They have a thorough understanding of quality systems and regulations and can apply this knowledge to CAPA processes.

Advanced competence definition

At an advanced level, an individual can provide strategic direction and oversight for CAPA processes, including integrating CAPA into the overall quality management system and using data analytics to identify trends and proactively address potential quality issues. They can lead complex CAPA projects involving multiple stakeholders and have experience with continuous improvement methodologies such as Six Sigma and Lean. They also have excellent communication and leadership skills to effectively collaborate with cross-functional teams and senior management.

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