CAPA: Corrective and Preventive Action
A systematic approach to identifying, investigating, and resolving quality issues while preventing their recurrence in laboratory operations.
What is CAPA?
- CAPA
- CAPA (Corrective and Preventive Action) is a fundamental quality management concept used in regulated industries, particularly in clinical and diagnostic laboratories. It provides a structured framework for identifying problems, determining root causes, implementing effective solutions, and preventing future occurrences.
The Two Components of CAPA
Corrective Action (CA)
Actions taken to eliminate the causes of an existing nonconformity or other undesirable situation. It addresses problems that have already occurred.
Preventive Action (PA)
Actions taken to eliminate the causes of potential nonconformities before they occur. It's proactive risk management based on trends and analysis.
CAPA Process Steps
Identification
Recognize and document the problem or potential issue through complaints, audits, or trend analysis
Evaluation
Assess the severity and impact to determine if CAPA investigation is warranted
Root Cause Analysis
Use systematic methods (5 Whys, Fishbone, etc.) to identify the fundamental cause
Action Planning
Develop specific, measurable corrective or preventive actions with timelines
Implementation
Execute the planned actions and document all changes made
Verification
Confirm that actions were completed and are effective
Effectiveness Check
Monitor over time to ensure the problem doesn't recur
CAPA in Laboratory Settings
In clinical and diagnostic laboratories, CAPA is essential for maintaining quality and regulatory compliance. Common triggers for CAPA investigations include:
- Proficiency testing failures
- Quality control out-of-range results
- Instrument malfunctions or calibration issues
- Patient complaint investigations
- Audit findings (internal or external)
- Process deviations and exceptions
- Trend analysis identifying systematic issues
Regulatory Requirements
CAPA systems are required by multiple regulatory frameworks including FDA 21 CFR Part 820 (Quality System Regulation), ISO 15189 (Medical Laboratories), ISO 17025 (Testing Laboratories), CLIA, and CAP accreditation standards.
Best Practices for Effective CAPA
Timely Initiation
Start CAPA investigations promptly to prevent issue escalation
Thorough Documentation
Maintain complete records of all CAPA activities and decisions
True Root Cause
Dig deep to find the actual cause, not just symptoms
Measurable Actions
Define clear, specific actions with success criteria
Cross-functional Input
Involve relevant stakeholders in the investigation
Trend Analysis
Look for patterns across multiple CAPAs to identify systemic issues