Risk management is an essential element of the quality management system (QMS) that spans over many functions within an organization. Risk management is the systematic process of applying procedures to identify, assess, control, and monitor risks. It is a fundamental requirement in the implementation of design controls in the Quality System Regulation (QSR). Risk management should be a part of the design control process of a medical device. Likewise, Risk Management should be part of Quality by Design for a drug.
Risk management involves the identification and description of hazards/failure modes, identification of events or circumstances that cause those hazards to occur, the expected consequences, and estimations or assessments of the risk to the patient and/or user. The estimation of risk for a given hazard is function of the probability of occurrence from harm and the severity of harm resulting from occurrence. After the estimation of risk, risk management focuses on controlling or mitigating risks.
We can help with risk management training and risk assessment, development, implementation and management of your risk assessment process. We can help your organization establish best practices and procedures to comply with ISO 14971 and international regulatory requirements.
Risk Management Plan
Identification of Hazards/ Failure Mode(s)
Residual Risk Evaluation
Risk/ Benefit Analysis
Overall Residual Risk
Risk Management Report