CAPA and root cause analysis, tools for an effective CAPA process

Managing the CAPA system – how to move from firefighting to improvement and learning.

This course will help you understand how to interpret the Corrective and Preventive Action requirements in ISO 13485:2016 and the US Food & Drug Administration’s Quality System Regulation. Through exercises and real-world examples, you will learn how to improve your CAPA process, from CAPA sources and preventive actions through root cause analysis, action plans and effectiveness check.

You will understand how to establish a compliant Corrective Action and Preventive Action (CAPA) process and how to make use of existing guidance and industry best practices to transform your CAPA process from a “must-do” to a tool for risk management and sustainable improvement.

Course outline:

• Scope and purpose of a CAPA system
• The relationship between risk management and the CAPA system
• Selection and evaluation of data sources and data elements
• Decision on when to initiate CAPA (or not) using risk-based approach.
• Tools for root-cause-analysis
• How to plan and verify Corrective and Preventive Actions
• Effectiveness check and CAPA closure
• Documentation and communication