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.