How to Plan and Implement an Effective Corrective Action System

Hi Everyone

Good evening…………

Today we are going to discuss on the purpose of a quality management system.

QMS is to help businesses improve abilities to consistently meet customer or regulatory requirements, according to the American Society for Quality.

A major component of a successful system is a corrective action program that adequately addresses non-conformance. The problem is that many systems become a burden rather than a tool for improvement, generally, because they are not well-planned prior to implementation.

CAPA Process

• Root cause investigation
• Conclusion & Quality design
• Action plan
• Implementation and follow up

Important Considerations

• Tie CAPA implementation to:
• Document control for products and processes
• Change control
• Ensure that controlled documents are reviewed and approved if changes are made.

NOTE: Closing CAPAs when actions are implemented, and tracking the effectiveness checks for CAPAs as a separate quality system metric. If closure takes more than 90 days, the CAPA should probably be converted to a Quality Plan. This is NOT intended to be a “work around” to give companies a way to extend CAPAs that are not making progress in a timely manner.