Quality Risk Management
Tools
Review Events
Failure Mode Effects Analysis (FMEA)
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Fault Tree Analysis (FTA)
Hazard Analysis and Critical Control Points (HACCP)
Breakdown large complex processes into manageable steps
Failure Mode, Effects and Criticallilty Analysis (FMECA)
Tree of failure modes combinations with logical operators
Systemic, proactive & preventative method on criticality
Hazard Operability Analysis (HAZOP)
Risk control
Risk Reduction
Risk Acceptance
Mitigation or avoidance of quality risk
Decision to
Accept the residual risk
Passively accept non specified residual risks
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
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FMEA & links severity, probability & detectability to criticality
Supporting Statistical Tools
Design of experiments (DOE)
Process Capability Analysis
Control Charts
Acceptance control charts
Shewhart control chart
Accumulative sum chart
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
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