Risk Assessment

Evaluating potential hazards

Risk assessment is defined by PDA Technical Report 54, Implementation of Quality Risk Management for Pharmacuetical and Biotechnology Manufacturing Operations, as "A systematic process of organizing information to support a risk decision to be made within a risk management process. It consists of identification of hazards and the analysis and evaluation of risk associated with exposure to those hazards". The risk assessment identifies an action, the plausible consequences involved and the controls in place to prevent the consequence from occuring to determine if the level of risk for the activity is acceptable or if existing controls need to be modified or new ones implemented.