QUALITY RISK MANAGEMENT RASHID MAHMOOD MSc. Analytical Chemistry MS in Total Quality Management Senior Manager Quality Assurance Nabiqasim Group of Industries Pakistan
What is Quality Risk Management? Quality Risk 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 Systematicprocess for the assessment, control, communication and review of risks to the quality of the medicinal product across the product lifecycle." (ICH Q9) Management QRM
Principles of Quality Risk Management 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. Two primary principles:
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? Initiate Quality Risk Management Process Risk Assessment Risk Identification Risk Analysis Risk Evaluation unacceptable R i n s o k i t a M Risk Control c a i n n a u g m Risk Reduction e m m o e C n t k t Risk Acceptance s o i o R l s Output / Result of the Quality Risk Management Process Risk Review Review Events Typical QRM process
Integrate QRM during product life cycle Gain experience Analyse root cause: Continuous improvement (Risk of) Failure ? Manufacture for market Quality Risk Management(QRM) Improve it Do, what you say Update documentation Approval Say, what you do
ICH Q9 Link back to patient risk Opportunities to impact risk using quality risk management Design Process Materials Manufacturing Facilities Distribution Patient
Implementing QRM Means The weakest chain will no longer be a problem.
Risk Assessment 3 fundamental questions • Risk IdentificationWhat might go wrong? • Risk AnalysisWhat is the likelihood (probability) it will go wrong? • Risk EvaluationWhat are the consequences (severity)? Note
Parameters for “calculating” Risks = Risk Priority Number A picture of the life cycle Severity Probability x Detectability x Refers to Refers to Refers to past today future Time
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
Severityand Probabilityaresimple 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.
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
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 qualitymanagement.”
Failure Mode & Effect Analysis (with Criticality) Criticality S x P 10 9 8 7 6 5 4 3 2 1 10 9 8 7 6 5 4 3 2 1 1 2 3 4 5 6 7 8 9 10 “SPD” or “Risk Priority Number (RPN)” S x P x D S P Severity of Effect Occurrence Probability Detection* *Higher detection ability lowers risk score.
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
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