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