Traditionally Hazard analysis and critical control point (HACCP) was adopted to do the risk assessment, Recently quality risk assessment is followed that is more relevant to the pharmaceutical industries. The guideline on Quality risk assessment to protect patient in terms of quality safety and efficacy of medicines.
In QRM a systematic science based decision making with respect to risk shall be considered. To intiate the QRM the problem shall be identified including possible risk. Detailed information shall be gathered which can lead to potential hazard or have harmful effect on human health and is relevant for the risk assessment