TYPES OF AUDITS, AUDITOR , AUDIT PROCESS, IMPORTANCE OF AUDIT FOR QUALITY RISK MANAGEMENT

2. DISCLAIMER

4. WHAT IS IN IT??

6. INTERNAL AUDIT

8. BENEFITS OF INTERNAL AUDIT

10. THE AUDIT SCHEDULE

11. THE TRAINED AUDITOR

12. MANAGING THE AUDIT

14. WHAT IS IT ?
Napo in Safe on Site - episode 003 - Heading for a fall - YouTube[via torchb.mp4

15. PRINCIPLES OF QRM

16. TYPICAL QRM PROCESS
Risk Review
RiskCommunication
Risk Assessment
Risk Evaluation
unacceptable
Risk Control
Risk Analysis
Risk Reduction
Risk Identification
Review Events
Risk Acceptance
Initiate
Quality Risk Management Process
Output / Result of the
Quality Risk Management Process
RiskManagementtools
• 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?

17. 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
Critical
Serious GMP non-
compliance
Patient injury possible
Moderate
Significant GMP non-
compliance
Impact on patient possible
Minor
Minor GMP non-
compliance
No patient impact

18. RISK ASSESSMENT
Risk = P x S
Severity
Probability Minor Moderate Critical
High
Unacceptable
risk
Intolerable risk Intolerable risk
Medium
Acceptable risk Unacceptable risk Intolerable risk
Low
Acceptable risk Acceptable risk Unacceptable
risk
Remote Acceptable risk Acceptable risk Acceptable risk

19. RISK ASSESSMENT

20. Severity (S)
Probability(P)
high
medium
low
risk
D
etectability(D
)
RISK ASSESSMENT

21. RISK CONTROL AND RISK REVIEW

22. QRM AND INTERNAL AUDIT

23. CONCERNS
?
Increasing
external
requirements
for best practice,
transparency and
compliance
• Public / Community
• Governments
• Regulators
• Investors / Creditors
Increasing
external
requirements
for 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 uncertainty
Growing
complexity and
Scope of risks
• Globalisation
“Multinational”
• Multi-factor approaches
• Regulatory expectations
• Acceptance of
risk and uncertainty
Increasing
efforts and costs for sustainability.
E.g documentation, projects,
Systems
Increasing
efforts and costs for sustainability.
E.g documentation, projects,
Systems

24. QRM
THROUGH
INT. AUDIT
QRM
THROUGH
INT. AUDIT
Proactive
disclosure
build trust and
understanding
Proactive
disclosure
build trust and
understanding
Improve
communication
through sharing best
practice and science
based knowledge
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
Master complexity
Convert data into knowledge
e.g. by using methodology and tools
NOVEL APPROACHES FOR QRM
THROUGH “INT. AUDIT”

25. CONCLUSION
Sharing information

26. WAY FORWARD