1. QUALITY RISK MANAGEMENT RASHID MAHMOOD MSc. Analytical Chemistry MS in Total Quality Management Senior Manager Quality Assurance Nabiqasim Group of Industries Pakistan

2. What is Quality Risk Management? Quality Risk Management QRM Definitions Degree to which a set of inherent properties of a product, system or process fulfills requirements. Combination of the probability of occurrence of harm and the severity of that harm Systematic process for the assessment, control, communication and review of risks to the quality of the medicinal product across the product lifecycle." (ICH Q9)

3. Principles of Quality Risk Management Two primary principles: The evaluation of the risk to quality should be based on scientific knowledge and ultimately link to the protection of the patient. The level of effort, formality and documentation of the quality risk management process should be commensurate with the level of risk.

4. Typical QRM process 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?

5. Integrate QRM during product life cycle Say, what you do Do, what you say Gain experience Improve it Approval Manufacture for market Analyse root cause: Continuous improvement Update documentation Quality Risk Management (QRM) (Risk of) Failure ?

6. ICH Q9 Link back to patient risk Process Materials Design Manufacturing Distribution Patient Facilities Opportunities to impact risk using quality risk management

7. Implementing QRM Means The weakest chain will no longer be a problem.

8. Risk Assessment Risk Identification What might go wrong? Risk Analysis What is the likelihood (probability) it will go wrong? Risk Evaluation What are the consequences (severity)? Note 3 fundamental questions

9. Parameters for “calculating” Risks A picture of the life cycle ProbabilityDetectability Severity pasttodayfuture Refers to Time Refers to = Risk Priority Number xx

10. What is RPN? RPN = (Severity) x (Probability) x (Detection) The RPN is used to prioritize action based upon the risk. For example the Risk Priority Number (RPN ) is categorized as below. Risk Levels ( SOPs Production) 1-125 -Low 126-343-Medium 344-1000-High

11. Severity and Probability are simple concepts? Which consequence is more severe? 300 lives lost in single plane crash. 300 lives lost on US roads over a weekend. 300 lives potentially lost from cancer within the next 20 years Which probability is most 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. Risk Management Methods and Tools Failure Mode Effects Analysis (FMEA) Break down large complex processes into manageable steps Failure Mode, Effects and Criticality Analysis (FMECA) FMEA & links severity, probability & detectability to criticality Fault Tree Analysis (FTA) Tree of failure modes combinations with logical operators Hazard Analysis and Critical Control Points (HACCP) Systematic, proactive, and preventive method on criticality Hazard Operability Analysis (HAZOP) Brainstorming technique Preliminary Hazard Analysis (PHA) Possibilities that the risk event happens Risk ranking and filtering Compare and prioritize risks with factors for each risk

13. Basic Quality Risk Management Facilitation Methods Some of the simple techniques that are commonly used to structure risk management by organizing data and facilitate decision-making are: Flowcharts Check Sheets Process Mapping Cause and Effect Diagrams (also called an Ishikawa diagram or fish bone diagram) “Risk management is the future of quality management.”

14. 14 Failure Mode & Effect Analysis (with Criticality) 10 9 8 7 6 5 4 3 2 1 Severity of Effect 10 9 8 7 6 5 4 3 2 1 Occurrence Probability S Criticality S x P 1 2 3 4 5 6 7 8 9 10 Detection* “SPD” or “Risk Priority Number (RPN)” P S x P x D *Higher detection ability lowers risk score.

15. Benefits of Quality Risk Management  Create baseline for more science-based decisions  Create awareness to maintain product quality throughout product life cycle.  No sudden surprises in operations  Better process and product understanding  Better monitoring and control strategy  Better utilization of resources  Reduced risks to patient  Regulatory compliance all the time

16. THANK YOU Email ID : rashid33hfd@hotmail.com Phone # : +923006658856 Skype : rashidsurge