COURSE OVERVIEW

This practical and highly-interactive course includes real-life case studies and exercises where participants will be engaged in a series of interactive small groups and class workshops. 

This course is designed to provide participants with a detailed and up-to-date overview of laboratory quality risk management. It covers the quality risk management (QRM) and its key elements; the international standards related to risk management in accordance with ISO 31000 and ISO 17025 standards; the various methods to identify risks and opportunities in analytical laboratory covering SWOT analysis, plan, identify, assess, handle and report; and the checklist for what-if analysis, known threats and hazards. 

 

Further, the course will also discuss the Delphi technique, structured or semi-structured interviews, failure mode and effect analysis (FMEA) and fault tree analysis (FTA); the hazard and operability analysis (HAZOP), scenario analysis and Ishikawa analysis (fishbone); evaluating the risk; the event tree analysis (ETA), risk- quantitative assessment and likelihood matrix (risk matrix or heat map); the risks and opportunities using pareto charts; and managing the risk in the laboratory. 

During this interactive course participants will learn the types of risks in the analytical laboratory, auditing risk and nonconforming work procedure; the quality risk assessment tools; controlling and mitigating strategies and integrating QRM in the organization; the critical success factors to consider when setting up or evaluating a quality risk management program including the importance of management support and suggestions for early risk assessment projects; and the key things to include in writing a procedure for risk assessment and management.