Module 14 2022

22/03/2022

THE RISK MANAGEMENT PROCESS

Masterclass: Lecture 2

The Organisation for Professionals in Regulatory Affairs

19

RISK ANALYSIS / RISK EVALUATION

 Determine the level of risk  High, medium, low  Identify and list characteristics that could affect safety  Identify associated hazards  Arising from correct intended use  And from foreseeable mis-use  Determine the SOURCE or CAUSE of the hazard  Assign a level of risk to each identified hazard  Plus probability and severity

Masterclass: Lecture 2

The Organisation for Professionals in Regulatory Affairs

20

10