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level: QUALITY RISK MANAGEMENT PROCESS

Questions and Answers List

Question	Answer
Risk Management Process	1 Initiation 2 Risk Assessment 3 Risk Control 4 Result/ Output 5 Risk Review - Review Events
Components of Risk Assessment	1 Risk Identification 2 Risk Analysis 3 Risk Evaluation
Components of Risk Control	1 Risk Reduction 2 Risk Acceptance
does not only refer to statutory, legislative or regulatory requirements, but also to the need to revisit the risk assessment process.	"unacceptable"
focuses on processes for mitigation or avoidance of quality risk when it exceeds a specified (acceptable) level. It might include actions taken to mitigate the severity and probability of harm.	RISK REDUCTION
is a decision to accept risk. It can be a formal decision to accept the residual risk or it can be a passive decision in which residual risks are not specified.	RISK ACCEPTANCE
is the sharing of information about risk and risk management between the decision makers and others. Communications might include those among interested parties; e.g., regulators and industry, industry and the patient, within a company, industry or regulatory authority, etc.	RISK COMMUNICATION
Risk management should be an ongoing part of the quality management process. The output/results of the risk management process should be reviewed to take into account new knowledge and experience. The frequency of any review should be based upon the level of risk.	RISK REVIEW