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Key Performance Indicators (KPIs) for CAPAs: An Essential Guide

April 25, 2025

By Imane Nohair, GxP Audit manager at Apotech

Corrective and Preventive Actions (CAPAs) are fundamental to quality process management in regulated industries such as pharmaceuticals and medical devices. CAPAs help identify issues and prevent their recurrence, ensuring compliance with standards like FDA 21 CFR Part 820, ISO 9001, and ICH Q10 (Pharmaceutical Quality System).

However, to ensure CAPAs are truly effective, organisations must measure their performance using Key Performance Indicators (KPIs). Below are the primary KPIs used to track and assess CAPA effectiveness.

1. CAPA Closure Rate

This indicator measures the percentage of CAPAs closed compared to the total number of CAPAs opened within a specific time frame.

🧮 Formula:
Closure Rate (%) = (Number of CAPAs closed / Total Number of CAPAs opened) × 100

📈 A high closure rate indicates effective CAPA execution, while a low closure rate may suggest delays in investigation, action implementation, or a backlog of unresolved issues.

📚 References (Examples):

  • FDA Guidance on Quality Systems Regulation (21 CFR 820.100) emphasizes the importance of timely CAPA closure.
  • ISO 13485 (Medical Devices) requires CAPAs to be resolved within an appropriate timeframe.

2. Average Resolution Time

This KPI assesses the average time taken to resolve a CAPA, from identification to implementation.

🧠 Why is it important?

  • A high resolution time may indicate inefficiencies in root cause analysis or action implementation.
  • A shorter resolution time suggests an agile and well-managed CAPA process.

📚 Reference:

  • ICH Q9 (Quality Risk Management) recommends timely CAPA implementation to mitigate risks effectively.
  • ISO 9001:2015 Clause 10.2 mandates organisations to resolve CAPAs promptly and evaluate their impact.

3. Problem Recurrence Rate

This KPI tracks how often previously addressed issues reappear.

🔍 Why monitor this?

  • A high recurrence rate suggests that corrective actions were ineffective or that underlying root causes were not properly addressed.
  • A low recurrence rate indicates strong root cause analysis and effective preventive measures.

📚 Reference:

  • ICH Q10 (Pharmaceutical Quality System) highlights the need for proactive CAPA measures to prevent recurrence.
  • FDA’s Pharmaceutical cGMPs for the 21st Century stresses continual monitoring to assess CAPA effectiveness.

4. Compliance to deadlines

This indicator measures the percentage of CAPAs completed by their assigned due dates.

🎯 Objective: Ensure that CAPA planning includes realistic deadlines and that teams meet them consistently.

📚 Reference:

  • ISO 14971 (Risk Management for Medical Devices) states that CAPAs should be completed within a timeframe proportional to the risk they address.
  • FDA Warning Letters frequently cite overdue CAPAs as a compliance issue.

5. CAPA Effectiveness

The ultimate measure of CAPA success is verifying whether the implemented actions have truly resolved the issue and prevented recurrence.

🔎 How to assess effectiveness?

  • Conduct post-implementation audits
  • Perform trend analysis on similar issues
  • Gather feedback from stakeholders

📚 Reference:

  • FDA’s Guide to Inspections of Quality Systems requires companies to verify the effectiveness of corrective actions.
  • ISO 9001:2015 Clause 9.1.3 recommends measuring CAPA effectiveness through internal audits and management reviews.

WHY MONITOR CAPA KPIs?

📈 Continuous Improvement: Identifies weaknesses in the CAPA process and enables improvements.
📏 Regulatory Compliance: CAPA tracking is essential for meeting industry standards and authorities’ requirements (e.g., FDA, EMA, ISO).
💰 Cost Reduction: Effective CAPA management minimizes risks and financial losses associated with non-conformance.

By tracking these KPIs, organisations can strengthen their CAPA process, ensure compliance, and foster a proactive quality culture. Implementing CAPAs effectively means not just solving problems but preventing them from occurring in the first place.

📚 Further Reading & Industry References:

  • FDA 21 CFR Part 820.100 – CAPA Regulations for Medical Devices
  • ICH Q10 – Pharmaceutical Quality System Guidelines
  • ISO 9001:2015 – Quality Management System Standards
  • EU GMP Chapter 1 – Pharmaceutical Quality System

📩 Need expert guidance? contact us