Performance-Based Auditing for Medical Devices - A Tool for FDA’s Case for Quality

Objectives

• Recognize the difference between compliance-based auditing and performance-based auditing.
• Learn how a performance-based audit program connects process metrics to key indicators of business performance.
• Learn how to apply:
  • Performance-based methodologies for preparing and conducting audits.
  • Statistical tools that assess process performance and product characteristics, including the use of Minitab statistical software.
  • A process performance scoring system (and connecting it with nonconformities).

Topics

• The fundamentals of performance-based auditing:
  • More robust methodologies for preparing and conducting audits
  • Auditor competence
  • Enhanced audit criteria that consider efficiency and effectiveness
  • Applied statistics for auditing
• Planning, conducting, and reporting a performance-based audit
• Linkages between the process approach to auditing and key performance indicators (KPIs)
• Measuring audit program effectiveness

Who Should Attend

Designed for experienced management system auditors who have successfully completed an auditing course and performed actual audits, as well as audit program managers and QMS management representatives.