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INTRODUCTION
AHSAN M SYEDALI
PROJECT MANAGER CMC
July 2015
Comparison of Various Risk
Assessment Techniques
AHSAN M SYEDALI
Manager CMC Quality and Compliance
QBiotics Limited
July 2017
DISCLAIMER
The opinion expressed in this presentation are solely those of the presenter and not necessarily
those of QBiotics Limited or PharmOut.
DISCLAIMER
MississippiAugust 1st 2007 the I-35W bridge collapsed
killing 13 and injuring 145.
LondonJune 2017, Grenfell Tower Fire killing 80+.
FDA Enforcement Statistics
Summary Fiscal Year 2016
2847 Recall Events
8305 Products.
• Design
• Material Quality
• Operations and Maintenance
• Are we managing risks
appropriately ?
• Management Responsibility
• Skilled Employees
• Facility
Organization
• SOPs
• Training
• Deviation
• Investigation
• CAPA
• Risk Assessment
Tools
• Failures
• Complaints
• Recall
Why?
• Selection of risk assessment tool
• Meaningful policy
• Fit for the purposeTechnique
Are we managing
risks appropriately ?
RISK ASSESSMENT TECHNIQUELow Medium High Vs RPN
RedSeverity = HighProbability = LowRisk Class = 2Detectability = Medium= Medium Risk Priority
PurpleSeverity = MediumProbability = MediumRisk Class = 2Detectability = Medium= Medium Risk Priority
RedSeverity = High = 5 Probability = Low = 15X1= 5Detectability = Medium = 3= Medium Risk Priority = 15
PurpleSeverity = Medium = 3Probability = Medium = 33X3=9Detectability = Medium = 3= Medium Risk Priority = 27
1
3
5
1 33 5 51
RISK ASSESSMENT TECHNIQUELow Medium High Vs RPN
RISK ASSESSMENT TECHNIQUE10 Layers, 5 layers, or 3 layers
3 Layer SeverityPatient Safety Impact
1 = Low
2 = Medium
3 = High
5 Layer SeverityPatient Safety Impact1 = Negligible
2 = Marginal
3 = Moderate
4 = Critical
5 = Catastrophic
10 Layer SeverityPatient Safety Impact1 = Low
2 = Negligible
3 = Marginal
4 = Moderate
5 = Marginally Critical
6 = Critical
7 = Very critical
8 = Catastrophic
9 = Dangerously catastrophic
10 = Disastrous
TECHNIQUE“Low Severity”
What exactly it means
Minor impact on patient safety or
product quality
No impact on patient safety or product quality
Low
Severity
Low
Severity
Severity = LowProbability = MediumRisk Class = 3Detectability = Medium= Low Risk Priority
Low Severity = Minorimpact on patient safety or product quality.
TECHNIQUE“Low Severity”
What exactly it means
No actionLow Severity = No impact on patient safety or product quality.
No action
No action
• Management Responsibility
• Skilled Employees
• Facility
Organization
• SOPs
• Training
• Deviation
• Investigation
• CAPA
• Risk Assessment
Tools
• Failures
• Complaints
• Recall
Why?
Quality may be free.
But it is certainly NOT a gift.
FMEA
Fishbone – FMEA
FTA-FMEA
Brainstorming-FMEA
HPLC vs HPLC-MS
