Decision maker: A person who has the ability and authority to make appropriate and timely quality risk decisions.

Detectability: The ability to detect or determine the presence, occurrence or fact of a hazard. Injury: Damage to health, including damage that may result from loss of product quality or effectiveness. Hazard: Potential source of harm Severity: A measure of the likely consequences of a risk factor

Risk: The combination of the probability of harm occurring and the severity of harm (ISO/EC Guide 51). Risk acceptance: The decision to accept a risk (ISO Guide 73). Risk analysis: An estimate of risks and identified risk factors. Risk Assessment: A systematic process of organizing information to support risk decisions made in a risk management process. It includes identification of risk factors, analysis and evaluation of risks associated with exposure to these risk factors. Risk communication: Sharing information about risk and risk management among decision makers and other risk stakeholders. Risk control: Actions to implement risk management decisions (ISO Guide 73). Risk assessment: The comparison of an estimated risk with a given risk criterion using a qualitative or quantitative scale to determine risk significance. Risk Identification: The systematic use of information to identify potential sources of harm (hazards) described by risk issues or problems. Risk Management: The systematic application of quality management policies, procedures and practices to risk assessment, control, communication and review tasks. Quality risk management: refers to the systematic process of assessing, controlling, communicating and reviewing risks throughout the production cycle of pharmaceutical (medical) products Risk reduction: Actions taken to reduce the probability of harm occurring and the severity of harm. Risk review: Consider (if possible) applying new knowledge and experience about risks to review or monitor the outputs/results of the risk management process.

Risks to quality should be assessed based on scientific knowledge and ultimately linked to the protection of patients

The strength, formality and documentation of the quality risk management process should be commensurate with the level of risk

Initiate the quality risk management process

risk assessment

risk control

risk review

risk management methodology