Root Cause Analysis for Corrective and Preventive Action (CAPA)

Using a reliable process to meet current quality standards to determine the verifiable causes of problems. Root cause analysis is a systematic method to determine the causes of non-conformances. To meet current quality standards, medical device companies must use a reliable process to determine the verifiable causes of problems.

The Quality Systems Regulation (21 CFR 820) and the Quality Management Standard for Medical Devices (ISO 13485:2003), require medical device companies to establish and maintain procedures for implementing corrective and preventive action (CAPA) as an integral part of the quality system. The CAPA system to identify problems may be initiated by any non-conforming event, trend, or finding, internal or external, relating to: materials, systems, components, finished devices, software, labeling, packaging, documentation, processes, tests, inspections, training, equipment, environment, maintenance, calibration, suppliers, distribution, design control or management review. A functional CAPA system is supported by robust root cause analysis.

Areas Covered in the seminar:

• Regulatory requirements for managing non-conformances.
• Recognizing and documenting non-conformances.
• Selecting specific problems for root cause analysis.
• Roles and responsibilities for conducting root cause analysis.
• Root cause analysis method.
• Implementing solutions based on identification of root causes.
• Management support for root cause analysis.

Who Will Benefit:

• Quality Managers
• Regulatory Affairs Managers
• Program Managers
• Project Managers
• Product Development Managers
• Research and Development Managers