Write Effective Root Cause Statements to Ensure Strong CAPAs

Corrective and Preventive Actions (CAPAs) are a foundational element within the Quality System.  In organizations worldwide, the clear understanding of a strong CAPA is negotiable.  Some CAPA owners and teams are excellent at ensuring CAPAs are thorough and effective. However, some organizations struggle with strong CAPAs. Why? Strong CAPAs are difficult to identify, challenging to implement, and subjective for the reviewer. I have reviewed thousands of CAPAs at organizations across the world, and the standard for an acceptable CAPA varies by the person who identifies the CAPA and the person who reviews and approves the CAPA.