​
Summary

CAPAs and Vigilance integrates corrective and preventive action management with medical device vigilance to ensure systematic problem resolution and safety communication. You implement structured processes through five key documents: Incident Assessment Forms for evaluating reportable events, Field Safety Notices for urgent user communication, CAPA Plans for systematic problem resolution, CAPA Reports for documenting implementation effectiveness, and Lists of CAPAs for trend analysis and management oversight.

​
Regulatory Context

Under 21 CFR Part 820.100 (Corrective and Preventive Action) and 21 CFR Part 803 (Medical Device Reporting):
  • CAPA procedures must be established and maintained for systematic problem resolution
  • Root cause analysis required to identify and eliminate causes of nonconformities
  • Medical Device Reports (MDRs) must be submitted for serious incidents within specified timeframes
  • Verification of effectiveness must be documented for all corrective actions
  • Field corrections and removals require FDA notification under 21 CFR Part 806
Special attention required for:
  • Class I recalls requiring immediate FDA notification
  • Software malfunctions affecting device safety or effectiveness
  • CAPAs resulting from FDA inspections or warning letters
  • Integration with complaint handling and post-market surveillance systems

​
Overview

CAPAs and Vigilance forms the cornerstone of post-market safety management by combining systematic problem resolution with proactive risk communication. This card ensures that quality issues, safety concerns, and adverse events receive appropriate investigation, correction, and prevention while maintaining transparent communication with users and regulatory authorities. The Incident Assessment Form provides your primary tool for vigilance compliance by systematically evaluating whether events meet regulatory reporting criteria. This structured assessment uses the three-criteria test to determine if incidents constitute serious and reportable events requiring formal notification to competent authorities. The form ensures consistent decision-making, maintains audit trails for regulatory inspections, and prevents both under-reporting of serious events and over-reporting of minor issues. Field Safety Notices serve as your rapid response mechanism for communicating urgent safety information to users when post-market surveillance reveals risks requiring immediate action. These standardized communications enable quick notification of users about hazards, provide specific corrective instructions, and coordinate protective actions before serious incidents occur. The notices demonstrate regulatory compliance, protect patient safety, and maintain stakeholder trust during crisis situations. The CAPA Plan establishes your systematic approach to problem resolution when quality issues, nonconformities, or safety concerns require structured intervention. This planning document guides root cause investigation, defines corrective actions to fix immediate problems, and establishes preventive actions to prevent recurrence. CAPA Plans ensure resource allocation, timeline management, and verification planning while connecting individual problems to your broader quality improvement strategy. CAPA Reports provide auditable evidence of effective problem resolution by documenting the execution and verification of planned corrective and preventive actions. These reports demonstrate implementation completeness, measure effectiveness through objective evidence, and support closure decisions based on verified problem resolution. They enable continuous improvement by documenting lessons learned and successful problem-solving approaches. The List of CAPAs creates centralized oversight of all corrective and preventive actions, enabling trend analysis, resource planning, and management review activities. This comprehensive register supports strategic quality improvement planning by identifying recurring themes, monitoring cycle times, and tracking effectiveness indicators across your organization. Together, these five documents create an integrated safety management system that transforms reactive problem-solving into proactive risk prevention. The system ensures that incidents trigger appropriate investigations, corrective actions address root causes rather than symptoms, and lessons learned contribute to systematic quality improvement. This comprehensive approach protects patients through early hazard identification, demonstrates regulatory compliance through systematic documentation, and builds stakeholder confidence through transparent safety communication. The CAPA and vigilance processes integrate seamlessly with your post-market surveillance for trend identification, risk management for hazard assessment, change management for implementing corrections, and clinical evaluation for benefit-risk reassessment. This integration ensures that safety signals transform into systematic improvements while maintaining the rigorous documentation required for medical device quality management.