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ICH Guideline Q9 - Quality Risk Management

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A presentation of the ICH guideline Q9 (Quality Risk Management). It discusses the basic risk management procedure, list of recognized risk management tools and its role in pharmaceutical industry.

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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
Risk Management The systemic application of quality management policies, procedures and practices to the tasks of assessing, controlling, communicating and reviewing risk.
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
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
Overview of a typical quality risk management process
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
Risk Assessment A systemic process of organizing information to support a risk decision to be made within a risk management process
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?
Risk Identification The systemic use of information to identify potential sources of harm referring to the risk or problem
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
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
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
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?
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
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
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
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
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
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)
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
Failure Mode Effects Analysis (FMEA)
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
Failure Mode, Effects, and Critically Analysis (FMECA)
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
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
Hazard Analysis and Critical Control Points (HACCP)
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
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
Preliminary Hazard Analysis (PHA)
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
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
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.
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
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ICH Guideline Q9 - Quality Risk Management

  • 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
  • 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