4.

4 Relevant definitions in the risk management process

Harm Damage to health of recipient, including the damage that can occur from loss of product quality or availability (loss of tissue, damage for the donor) Hazard Risk assessment Risk analysis Risk evaluation The potential source of harm contains risk identification, risk analysis and risk evaluation. The estimation of the risk associated with the identified hazards The comparison of the estimated risk to given risk criteria, using a quantative or qualitative scale, to determine the significance of the risk Risk control Risk review contains risk reduction or risk acceptance contains an evaluation or review after a period of time to assess the measures taken and define if the identified risks are reduced effectiveley

Based upon the 3 principles of risk management, the definition of risk management could be stated as follows:

Risk management is the overall quality management process by which risks are identified, evaluated, controlled, monitored and reviewed. Severity = the degree of harm Probability/occurrence/possibility = the likely rate of occurrence

Risk = severity x probability (x detectability)

Figure 1 Schematic overview of risk

Figure 2 presents a schematic overview of all steps taken in a typical risk management process. The tools for risk management and the communication on the risk management process are important factors in the risk management process and are therefore drawn on the sides of the process, to underline their mutual dependency.

Figure 2: Overview of a typical quality risk management process (source: GMP annex 20)

Figure 3 represents the risk management process in another graphic and more simplified way and is adapted from ISO 14971.

Figure 3: Overview of the risk management process (source ISO 14791)