Please enable JavaScript.
Coggle requires JavaScript to display documents.
Quality Risk Management (Tools (Supporting Statistical Tools (Control…
Quality Risk Management
Tools
-
Failure Mode, Effects and Criticallilty Analysis (FMECA)
FMEA & links severity, probability & detectability to criticality
-
-
-
-
-
Risk control
Risk Reduction
-
It might be appropriate to revisit the risk assessment during the life cycle for new risks or increased significance of existing risks
-
Example
Hazards that have been assessed and risks that have been accepted
Hazards which have been identified but the risks have not been correctly assessed
Hazards that have not yet been identified
Hazards which are not yet linked to the patient risk
-
Risk assessment
Risk evaluation
- compares the identified and analyses risk against given risk criteria —strength of evidence
Risk identification
- to identify hazards
- address questions,identify possible consequences
- provide further step in QRM
Risk analysis -associatedwithidentifiedhazards
- linking likelihood of occurrence and severity of harms
- detectability is factor in estimation of risk
-
-