Risk management principles are used effectively in many areas of business and administration, such as finance, insurance, occupational health, public health, pharmacovigilance, and by competent authorities and bodies. Although there are some examples of the use of quality risk management in the pharmaceutical industry, they are limited and do not represent the possibilities offered by quality risk management. Furthermore, the importance of quality systems is recognized in the pharmaceutical industry, and it is becoming clear that quality risk management is an important component of an effective quality system. It is commonly accepted that risk is defined as the combination of the probability of harm occurring and its severity. However, it is difficult to develop a common approach to the application of quality risk management among different stakeholders, as perceptions of potential harm, its probability of occurrence, and its severity may differ.