fmea risk analysis example
TRANSCRIPT
Failure Mode and Effects Analysis (FMEA) Risk Analysis ExampleAcupuncture Needles
Process Step
Mode Kegagalan
AkibatSev1-3
Penyebab ControlsProb1-3
Risk Index
Saran Tindakan
InspectionDefective needle is missed
Patient injury - bruise
Insufficient sampling planOperator error (missed defect)
Provide training and visual guidance on inspection techniques
Patient injury – broken needle under skin
Insufficient sampling plan
Operator error (missed defect)
Provide training and visual guidance on inspection techniques
Unusable needle
Insufficient sampling plan
Operator error (missed defect)
Provide training and visual guidance on inspection techniques
Load autoclave
Load is not balanced
Incomplete sterilization
Operator Error
Document states to distribute load evenly
Add load diagram to document
Bioburden QC testing Validate bioburden test method
Unit is over-loaded
Incomplete sterilization
Operator Error
Document provides load/program matrix
Validate load capacities
Bioburden QC testing Validate bioburden test method
Unit is under-loaded
Deformed needle housing – unusable needle
Operator Error
Document provides load/program matrix
Validate load capacity
Visual inspection during packaging/ assembly operation
Run autoclave program
Incorrect program is selected
Incomplete sterilization
Operator Error
Lot file review includes equipment printout review
Fix batch sizes and use a single program
Bioburden QC testing Validate bioburden test method
Entire cycle is not run
Incomplete sterilization
Equipment failure Preventive maintenance
Power failure Connect to emergency generator; allow repeat run
Cycle does not meet max temperature
Incomplete sterilization
Equipment is out of calibration
Annual calibration check Run each cycle with biological indicators
Inspect needles
Load needles into autoclave
bags
Run program
Load autoclave
Unload autoclave
Transfer bags to
packaging Flow Charts