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DISCLAIMER
WHAT IS IN IT??
INTERNAL AUDIT
BENEFITS OF INTERNAL AUDIT
THE AUDIT SCHEDULE
THE TRAINED AUDITOR
MANAGING THE AUDIT
WHAT IS IT ?
Napo in Safe on Site - episode 003 - Heading for a fall - YouTube[via torchb.mp4
PRINCIPLES OF QRM
TYPICAL QRM PROCESS
Risk Review
Ris
k C
om
mu
nic
atio
n
Risk Assessment
Risk Evaluationunacceptable
Risk Control
Risk Analysis
Risk Reduction
Risk Identification
Review Events
Risk Acceptance
InitiateQuality Risk Management Process
Output / Result of theQuality Risk Management Process
Risk M
anage
ment tools
• What might go wrong or has gone wrong?
• What is likelihood or probability?
• What are the consequences (severity)?
• What is the level of risk? Any mitigating factors?
RISK ASSESSMENT
P – Probability of Occurrence
High Likely to occur
Medium May occur
Low Unlikely to occur
Remote Very unlikely to occur
S – severity level if event occurs
CriticalSerious GMP non-compliancePatient injury possible
ModerateSignificant GMP non-complianceImpact on patient possible
MinorMinor GMP non-complianceNo patient impact
RISK ASSESSMENT
Risk = P x SSeverity
Probability Minor Moderate Critical
HighUnacceptable risk
Intolerable risk Intolerable risk
MediumAcceptable risk Unacceptable risk Intolerable risk
LowAcceptable risk Acceptable risk Unacceptable
risk
Remote Acceptable risk Acceptable risk Acceptable risk
RISK ASSESSMENT
Severity (S)
Pro
babi
lity
(P) high
medium
low
risk
Detecta
bility
(D)
RISK ASSESSMENT
RISK CONTROL AND RISK REVIEW
QRM AND INTERNAL AUDIT
CONCERNS
?Increasing external requirementsfor best practice, transparency and compliance
• Public / Community• Governments• Regulators• Investors / Creditors
Growing complexity and Scope of risks
• Globalisation “Multinational” • Multi-factor approaches• Regulatory expectations • Acceptance of risk and uncertaintyIncreasing
efforts and costs for sustainability. E.g documentation, projects, Systems
QRM THROUGH INT. AUDIT
Proactive disclosure
build trust and understanding
Improve communication
through sharing best practice and science
based knowledge
• An appropriate integrated approach helps to meet requirements more efficiently
Master complexity Convert data into knowledge
e.g. by using methodology and tools
NOVEL APPROACHES FOR QRM THROUGH “INT. AUDIT”
CONCLUSION
Sharing information
WAY FORWARD
