Re-Thinking CAPA

CAPA is an acronym for “Corrective Action / Preventive Action”. If you've been involved with the Quality profession for longer than 10 minutes, you've probably heard this term.

The short answer is because CAPA makes a general assumption that is often incorrect.

To explain this, let's quickly cover the definitions for these two terms. For sake of consistency, I'll use the definitions provided in ISO 9000:2015, “Quality management systems–Fundamentals and Vocabulary”.

3.21.1 Preventive Action
action to eliminate the cause of a potential nonconformity or other potential undesirable situation

Note 1 to entry: There can be more than one cause for a potential nonconformity.
Note 2 to entry: Preventive action is taken to prevent occurrence whereas corrective action is taken to prevent recurrence.