Criticality Assessment- Identification of Critical Quality Attributes ...

Risk Assessment: FMEA for Roller Compaction Unit
Operation
Potential Failure Potential Effect Of
Failure
No Roll Gap Control - Not be able to achieve
cannot maintain control compression parameters
Not be able to achieve
compression parameters
Not be able to achieve
compression parameters
Mill Unit Failure
material sticking
Not be able to achieve
compression parameters
large particles, foreign
matter, contamination,
incompressibility
Severity
Potential Causes
Occurance
Controls
3 Failure of Gap
control system
2 particle size PAT 2 12 6
3 API particle size; 2 Raw material physical 1 6 6
morphology
characteristics
3 Flow of blend, 2 Raw material
2 12 6
material bridging characteristics, rotary
valve, gap safety
shutoff, particle size
PAT
3 Improper set up, 2 training, tolerance and 2 12 6
preventive
maintenance,
equipment failure
feedback control loops
3 screen breakage 1 Particle Size PAT 2 6 3
burn granulation 3 clog of screen 1 Particle Size PAT,
material backup
Flow issues of blend; excess
fines
large particles,
incompressibility,
eventually damage
equipment
2 milling speed
incorrect,
computer failure
1 control loops rpm,
particle Size PAT
3 improper setup 1 training, particle size
PAT
Detection
RPN
2 6 3
2 4 2
2 6 3
Change in porosity, 3 Material sticking to 1 visual observation, 2 6 3
the kerning
scraper set up
Reduce Throughput 1 Material sticking to 1 visual observation, 2 2 1
the kerning
scraper set up
Total Risk Priority Number= 72
Pfizer • 27
Criticality