RISK MANAGEMENT TOOLS - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 18

Initiate
quality risk management process
Risk assessment
Risk identification
Risk analysis
Risk evaluation
Unacceptable
Risk control
Risk reduction
Risk acceptance
Output/result of the
quality risk management process
Risk review
Review events
Figure 2.1 Typical quality risk management process.
review historical records, gather shared corporate knowledge, and systematically
evaluate the risk posed by the system under evaluation. Each of the identified
risks must be evaluated to identify those risks that are realistic and therefore
must be addressed. As the process summarized in Figure 2.1 is followed, the
next steps are discussed below.
2.3.1.2 Risk Analysis Using the information that is available at the time of
the investigation, each identified hazard is systematically analyzed qualitatively,
quantitatively, or semiquantitatively to examine estimated risk under various
conditions: