1. ICH Q9: Quality Risk Management
MunaAli B.Pharm.
SaharAnsariM.Sc.
Pharmaceutical Quality Control and Quality Assurance (QC/QA) Postgraduate Program
Presented at Academy of Applied Pharmaceutical Science (AAPS), Toronto, ON
2013-2014

2. Risk Management
The systemic application of quality management policies, procedures and practices to the tasks of assessing, controlling, communicating and reviewing risk.

3. Principles of Quality Risk Management
1.The evaluation of the risk to quality should be based on scientific knowledge and link to the protection of the patient
2.The level of effort, formality and documentation of the quality risk management process should be of the same level/measure of risk

4. Quality Risk Management Team
•Experts from the appropriate areas (e.g. quality unit, business development, engineering, regulatory affairs, production and sales)
•Individuals who are knowledgeable about the quality risk management process

5. Overview of a typical quality risk management process

6. Initiating a Quality Risk Management Process
•Define the problem and/or risk
•Assemble background information on the potential hazard, harm or human health impact
•Identify a leader and necessary resources
•Specify a timeline and appropriate level of decision making

7. Risk Assessment
A systemic process of organizing information to support a risk decision to be made within a risk management process

8. Risk Assessment
Three fundamental questions for clearly defining the risk(s)
1.What might go wrong?
2.What is the probability it will go wrong?
3.What are the consequences?

9. Risk Identification
The systemic use of information to identify potential sources of harm referring to the risk or problem

10. Risk Analysis
The estimation of the risk associated with the identified hazards. It is the qualitative or quantitative process of linking the probability of occurrence and severity of harm

11. Risk Evaluation
The comparison of the estimated risk to given risk criteria using a qualitative or quantitative scale to determine the significance of the risk

12. Risk Control
•Actions implementing risk management decisions
•The purpose is to reduce the risk to an acceptable level
•The amount of effort used in risk control should be proportional to the significance of risk

13. Risk Control
•Is the risk above an acceptable level?
•What can be done to reduce or eliminate risks?
•What is the appropriate balance between benefits, risks and resources?
•Are new risks introduced as a result of the idetified risks being controlled?

14. Risk Reduction
•Actions taken to lessen the probability of occurence severity of the harm
•Risk reduction measures might introduce new risks into the system or increase the significance of other risks
•Revisit risk assessment to identify and evaluate any possible change

15. Risk Acceptance
•The decision to accept the risk
•The best quality risk management might not entirely eliminate risk
•The quality risk is reduced to a specified acceptable level which will decided on a case-by-case basis

16. Risk Communication
•The sharing of information about risk and risk management between the decision maker and other stakeholders
•Parties could coomunicate at any stage of the process
•The output/result should be appropriately communicated and documented

17. Risk Review
•Review or monitoring of output/results of the risk management
•The process should be utilized for events (planned or unplanned events)
•The frequence of any review should be based on the level of risk
•Risk review might include reconsideration of risk acceptance decisions

18. List of recognized risk management tools
•Basic risk management facilitation methods
•Failure Mode Effects Analysis (FMEA)
•Failure Mode, Effects and Criticality Analysis (FMECA)
•Fault Tree Analysis (FTA)
•Hazard Analysis and Critical Control Points (HACCP)
•Hazard Operability Analysis (HAZOP)
•Preliminary Hazard Analysis (PHA)
•Risk ranking and filtering
•Supporting statistical tools

19. Basic Risk Management Facilitation Methods
Commonly used to structure risk management by organizing data and facilitating decision making
•Flowcharts
•Check sheets
•Process Mapping
•Cause and effect diagram (Ishikawa diagram)

20. Failure Mode Effect Analysis (FMEA)
•An evaluation of potential failure modes and their likely effect on outcomes and/or product performance
•It is a powerful tool for summarizing the important modes of failure, factors causing these failures and the effect of these failures
•Potential Areas of Use(s)
1.To prioritize risks and monitor effectiveness of risk control activities
2.To analyze manufacturing operation and its effect on product or processes

21. Failure Mode Effects Analysis (FMEA)

22. Failure Mode, Effects and Critically Analysis (FMECA)
•FMEA extended to incorporate an investigation of the degree of severity of the consequences, their probabilities of occurrence and their detectability
•Potential Areas of Use(s)
1.For failures and risks associated with manufacturing processes
2.The output of FMECA is a relative risk score for each failure mode and is used to rank the modes of failure

23. Failure Mode, Effects, and Critically Analysis (FMECA)

24. Fault Tree Analysis (FTA)
•It is an approach that assumes failures of the functionality of a product or process
•This tool can combine multiple causes of failure by identifying casual chains
•Potential Areas of Use(s)
1.To establish the pathway to the root cause of the failure
2.To investigate complaints and deviations in order to fully understand their root cause
3.For evaluating how multiple factors affect a given issue
4.Useful for risk assessment and in developing monitoring programs

25. Hazard Analysis and Critical Control Points (HACCP)
•Its is a structured approach that applies technical and scientific principles to analyze, evaluate, prevent and control the risk due to the design, development, production, and use of the products
•Potential Areas of Use(s)
1.To identify and manage risks associated with physical, chemical and biological hazards (including microbiological contamination)
2.Useful when product and process understanding is sufficiently comprehensive to support identification of critical control points

26. Hazard Analysis and Critical Control Points (HACCP)

27. Hazard Operability Analysis (HAZOP)
•HAZOP is based on a theory that assumes that risk events are caused by deviations from the design or operating intentions.
•Potential Areas of Use(s)
1.Applied to manufacturing processes
2.The output of a HAZOP analysis is a list of critical operations for risk management which facilitates regular monitoring of critical points in manufacturing process

28. Preliminary Hazard Analysis (PHA)
•It is a tool of analysis based on applying prior experience or knowledge of hazard or failure to identify future hazards that might cause harm
•Potential Area of Use(s)
1.Analyzing existing system or prioritizing hazards
2.Used early in the development of a project where there is little information on design, details or operating procedures

29. Preliminary Hazard Analysis (PHA)

30. Risk Ranking and Filtering
•It is a tool for comparing and ranking risks which requires the evaluation of multiple quantitative and qualitative factors for each risks
•This tool involves in breaking down a basic risk question into as many component as needed to capture factors involved in the risk
•Potential Areas of Use(s):
1.Used to prioritize manufacturing sites for inspection/audits by regulators or industry
2.Useful when management needs to evaluate both quantitatively-assessed risks and qualitatively-assessed risks within the same organizational framework

31. Supporting Statistical Tools
•Statistical tools can enable effective data assessment, aid in determining the significance of the data set(s) and facilitate more reliable decision making
•List of some of the principal statistical tools used in the pharmaceutical industry:
1.Control Charts
2.Control Charts with Arithmetic Average and Warning Limits
3.Histograms
4.Pareto Charts
5.Process Capability Analysis

32. Conclusion
•Quality Risk Management is a process that supports science-based and practical decisions when integrated into quality systems
•It provides documented and reproducible methods to accomplish steps to the quality risk management process
•Appropriate use of quality risk management does not eliminate industry's obligation to comply with regulatory requirements.

33. References
•http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q9/Step4/Q9_Guideline.pdf
•http://eurogtps.com/PROJECTOUTCOMES/EuroGTPHOTTOPICS/4RISKMANAGEMENT/44Relevantdefinitionsintheriskmanagementpr/tabid/246/Default.aspx
•http://www.fmea-fmeca.com/fmea-examples.html
•http://www.emeraldinsight.com/journals.htm?articleid=1463554
•http://www.qualitytrainingportal.com/resources/problem_solving/problem-solving_tools- fault_tree.htm
•http://www.beverageonline.com/doc/gary-ades-on-food-safety-haccp-haccp-haccp-pa- 0004
•http://www.oshatrain.org/notes/2bnotes18.html

34. Questions?

35. Thank You