Quality risk management


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Simple presentation to understand the elements in the quality risk management process.

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Quality risk management

  3. 3. GMP TRAINING – SYMED LABS OBJECTIVES    3 To provide information on the background of the ICH Q9 document Give an aid by providing some points of discussions on the understanding of the quality risk management concept Illustrations of how Risk Management can be applied Pharmaceutical Industry
  4. 4. GMP TRAINING – SYMED LABS PREAMBLE  Risk: A situation involving exposure to danger  E.g.: Driving with out wearing helmet   4 Accident: An unfortunate incident that happens unexpectedly and unintentionally, typically resulting in damage or injury Risk Management: A systematic process for the assessment, control, communication and review of risks.
  5. 5. GMP TRAINING – SYMED LABS Former methods for Quality Risk Management  Methods of risk management in earlier days:      5 Trends review Check lists Maps Flow Charts Compilation of observations
  6. 6. GMP TRAINING – SYMED LABS Potential areas for Risk Management application          6 Documentation [SOPs, Batch records etc.] Training [Schedules and effectiveness] Quality defects [Complaints, deviations, OOS etc.] Audits [Compliance] Periodic reviews [Revalidation assessment] Change controls [Impact assessment] Facilities, Equipment and Utilities [Components, maintenance ] Material management [Receipt, storage and distribution] Packaging and labeling [Container closure system and labeling]
  7. 7. GMP TRAINING – SYMED LABS Approaches to Quality Risk Management  In general we are using two approaches to manage the risks ...  Pro active: Identify the treat exposure areas to mitigate the potential for loss, before the loss occurs.   Reactive: Investigate the treat exposure areas to identify the potential source for loss and its control, after the loss occurs.  7 E.g.: Analysis before implementation. E.g.: Failure investigations.
  8. 8. GMP TRAINING – SYMED LABS Area of scope for Risk Management Area for Opportunities to manage the risk Design Process Materials Facilities 8 Manufacturing Distribution Patient
  9. 9. GMP TRAINING – SYMED LABS Risk Based Concepts by ‘ICH’ “risk-based” concepts and principles Q8 9 Q9 Q10 Q11
  10. 10. GMP TRAINING – SYMED LABS Risk Based Concepts by ‘ICH’ 10 ksi R Q10 Pharm. Quality Systems High Low Using Q9 Quality Risk Management Q8 Pharmaceutical Development Low High principles
  11. 11. GMP TRAINING – SYMED LABS METHODS FOR RISK ASSESSMENT   11 Qualitative: The ‘What’ analysis Quantitative: The ‘How much’ analysis
  12. 12. GMP TRAINING – SYMED LABS Severity and Probability are simple concepts?  Which consequence is more severe?     300 lives lost in single, fiery plane crash. 300 lives lost on roads over a weekend. 300 lives potentially lost from cancer within the next 20 years Which probability is probable? What does a “30% chance of rain tomorrow” mean?  30% of the days like tomorrow will have at least a trace of rain.  30% of the area will have rain tomorrow.  30% of the time tomorrow, it will rain. 12
  13. 13. GMP TRAINING – SYMED LABS de te ct ab i lit y Parameters for evaluating the ‘Risk’… probability hig h me d ium low 13 severity
  14. 14. GMP TRAINING – SYMED LABS Estimation of Risk through RPN..? Risk Priority Number = P X D X S Probability (P) x Detectability (D) x Severity (S) Refers to Refers to Refers to 14 past today future time
  15. 15. GMP TRAINING – SYMED LABS Calculation of Risk Priority Number…. Rating scale for Risk: Low=1 Moderate=2 High=3 Risk Priority Number (RPN) = P X D X S RPN Scale: Low: 0 to 9 15 Moderate: 10 to 18 High: 19 to 27
  16. 16. GMP TRAINING – SYMED LABS Over view of typical QRM process… Initiate Quality Risk Management Process Risk Assessment Risk Identification Risk Analysis unacceptable Risk Control Risk Reduction Risk Acceptance Output / Result of the Quality Risk Management Process Risk Review 16 Review Events Risk Management tools Risk Communication Risk Evaluation
  17. 17. GMP TRAINING – SYMED LABS Basic Risk Management Tools…       17 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);
  18. 18. GMP TRAINING – SYMED LABS Failure Mode Effect Analysis (FMEA) concept… FMEA provides for an evaluation of potential failure modes for processes and their likely effect on outcomes and/or product performance. Once failure modes are established, risk reduction can be used to eliminate, contain, reduce or control the potential failures. FMEA relies on product and process understanding. FMEA methodically breaks down the analysis of complex processes into manageable steps. It is a powerful tool for summarizing the important modes of failure, factors causing these failures and the likely effects of these failures. 18
  19. 19. GMP TRAINING – SYMED LABS Failure Mode Effect Analysis (FMEA) Process….      19 Identify an area where risk exists. Describe the system and function Create a block or process flow diagram indicating relationships within the process Create a worksheet containing information about the system (related block diagram) What is important is that you have a process to analyze potential failure modes (i.e. problems that could happen) AND the potential effects of that failure on your process.
  20. 20. GMP TRAINING – SYMED LABS STEP #1: Selecting the High Risk Process Examples of how you can do this: Lengthy process with more stages.  High risk of failures in the process.  Top failed product in the history.  Processes that are heavily dependent on human intervention.  Product manufacturing in the oldest facility.  Process/Facility with rapid changes.  20
  21. 21. GMP TRAINING – SYMED LABS STEP #2: Forming the assessment team The assessment team should be Subject matter expert.  Cross functional.  To cover all levels.  Solid understanding to the process being assessed.  Well experienced on the process being assessed.  Well qualified with strong analytical skills.  21
  22. 22. GMP TRAINING – SYMED LABS STEP #3: Diagram the process Map the process with flow charting Clearly define the process with simple steps.  Don’t skip the critical steps during mapping.  Determine how things intended to work Vs. how thing actually working.  Consult the experts to determine the best practices for the process.  Allow team to the work site to observe the process steps before mapping of process diagram.  22
  23. 23. GMP TRAINING – SYMED LABS STEP #4: Identify the potential failure modes  Process can have multiple failure modes and each failure mode can have multiple effects.  Address the following questions during failure modes identification. What could fail with this step? (Failure modes)  Why would this failure occur? (Causes)  What could happen if failure occurs? (Effects)  23
  24. 24. GMP TRAINING – SYMED LABS STEP #5: Assess the failure modes and Causes Risk mitigation requires an understanding of the Severity, probability and detestability of the exposure.  Use clear scale for rating of risk consistently.  Keep the scales simple and ensure they are appropriate to the exposure and organizations risk tolerance.  Causes identification should be transparent to mitigate the risk effectively.  24
  25. 25. GMP TRAINING – SYMED LABS STEP #6: Assessment of critical failure modes  The highest RPN’s should be focused on first and should be considered as critical.  Ask the following questions during assessment What might cause the failure to occur?  When might the failure occur?  Where might the failure occur?  Why might the failure occur?  25
  26. 26. GMP TRAINING – SYMED LABS STEP #7: Redesign the process  Considerations for the redesignation of the process. If identified the critical failure mode.  If inadequate controls are exists.  If existing process not robust.   26 Direct the redesignated process prior to its wide spread implementation.
  27. 27. GMP TRAINING – SYMED LABS Frame work for Failure Mode Effect Analysis Assesses the steps of the process and identify where the problems may occur.  Identify consequences of each failure mode should it occur.  Scores the exposures quantifiably.  The highest RPN’s should be focused on first.  Assists with better understanding of the process.  Brain storming is the critical to the process.  27
  28. 28. GMP TRAINING – SYMED LABS Concerns regarding QRM implementation     28 Hiding risks Writing half the truth (e.g. in an investigation report) A means of removing industry’s obligation to comply with regulatory requirements Both Companies & Inspectors have to think and not simply follow black and white rules
  29. 29. GMP TRAINING – SYMED LABS Conclusions for ICH Q9  Over all: Positive Contribution to patient protection  Further develops Quality Risk Management awareness, that is already part of industry and regulatory culture  Ongoing change in behaviour  Identifying risks can be positive  A long list of identified risks that are assessed and controlled provides high quality capability Awareness of quality risks  “Risk-based approach”  A potential of risks remains - No “Zero” risk!  29
  30. 30. GMP TRAINING – SYMED LABS Change in behavior…. From tick-box approach for compliance Towards systematic risk-based thinking 30
  31. 31. GMP TRAINING – SYMED LABS Conclusion  The weakest link in the chain will no longer.... be a problem. The use of Quality Risk Management is mandatory is an expectation of EU & PICs GMP However, if you don’t use it, 31 you will not gain the benefits