LE0433-3D : FMEA Risk Management

This highly-interactive course includes various practical sessions and exercises. Theory learnt will be applied using the “MS Excel” application.
This course is designed to provide participants with a detailed and up-to-date overview of Laboratory FMEA Risk Management. It covers the purpose, principles and benefits of FMEA; the relationship between failures, hazards, risks, and consequences; the types and applications of FMEA, establishing FMEA scope and building an effective FMEA team; the laboratory processes, functions and FMEA and ISO/IEC 17025 risk-based thinking; the identification of potential failure modes and analysis of failure effects; the failure causes, existing prevention and detection controls; the severity, occurrence and detection ratings; the risk priority number, risk prioritization, root-cause analysis within FMEA and practical root-cause analysis techniques; developing corrective and preventive actions; and the CAPA management and effectiveness verification.
During this interactive course, participants will learn the risk treatment hierarchy, reassessment, residual risk evaluation and FMEA for laboratory equipment; integrating maintenance and reliability practices, equipment criticality and reliability analysis; the supplier, procurement and inventory risk FMEA; the FMEA software tools and digital documentation; the LIMS, data-integrity risk analysis, risk monitoring and key risk indicators; the FMEA review, lifecycle management and FMEA and management of change; and the FMEA for continuous improvement.