Course Code: ELM-117-09

CAPA Basics: Corrective Action

Corrective Action Defined

The first ‘half’ of CAPA is “Corrective Action.”

Systemic Nonconformities

As noted, this is triggered when systemic nonconformities are identified.

Preventing Recurrence

Unfortunately, the language in 820 propagates a little confusion. In addressing a CA, actions must be taken to prevent recurrence of the nonconformity.

Author

Don Hurd

Practical Quality & Thorough Validation The Realtime Group