CAPA
Short for Corrective and Preventive Action
A structured process for investigating quality problems, implementing fixes, and preventing recurrence. Core to ISO 9001 and FDA quality systems.
Definition
CAPA is a systematic approach to problem-solving required by ISO 9001, ISO 13485, FDA 21 CFR 820.100, and most regulatory quality frameworks. 'Corrective action' addresses a problem that has already happened. 'Preventive action' addresses a risk before it causes a problem. A CAPA system requires documented procedures for identifying issues (customer complaints, audit findings, deviations), investigating root causes, implementing actions, verifying effectiveness, and closing out the record.
Why it matters
CAPA effectiveness is the most common weak spot auditors identify. Regulators routinely find that organizations open CAPAs, put in superficial fixes, and close them without verifying the problem actually stopped. Strong CAPA SOPs — with defined escalation criteria, required root cause analysis, and verification requirements — are among the highest-value quality procedures a regulated business can maintain.
Related terms
A documented, step-by-step process for performing a routine business task consistently and safely.
A structured investigation method that identifies the underlying cause of a problem rather than treating its symptoms.
The international standard for quality management systems, requiring documented procedures, continuous improvement, and risk-based thinking.
Regulatory requirements ensuring pharmaceutical, medical device, and food products are consistently produced to quality standards.