Quality Risk Management Tools Quality Risk Management Tool Selection When to Select FMEA: QRM Tool Selection Matrix

Transcription

1 Quality Risk Management Tools Quality Risk Management Tool Selection When to Select FMEA: QRM Tool Selection Matrix 26

2 Quality Risk Management Tools The ICH Q9 guideline, Quality Risk Management, provides a list of methods widely used in the industry for risk management: No. Risk Management Method 1. Basic risk management facilitation methods (flowcharts, check sheets, cause and effect diagram etc.) Organize data and facilitate decision making in the areas of failure investigations and root cause analysis 2. Failure Mode Effects Analysis (FMEA) Prioritize risks Potential Areas of Use(s) Monitor the effectiveness of risk control activities Equipment and facilities Analyse a manufacturing process to identify high-risk steps or critical parameters 3. Failure Mode, Effects, & Criticality Analysis (FMECA) Utilized on failures and risks associated with manufacturing processes 4. Fault Tree Analysis (FTA) Establish the pathway to the root cause of the failure Investigate complaints or deviations to fully understand their root cause Ensure that intended improvements will fully resolve the issue and not lead to other issues Evaluate how multiple factors affect a given issue 5. Hazard Analysis and Critical Control Points (HACCP) Identify and manage risks associated with physical, chemical and biological hazards Useful when process understanding is sufficiently comprehensive to support identification of critical control points (critical parameters / variables) Facilitates monitoring of critical points in the manufacturing process 27

3 No. Risk Management Method 6. Hazard Operability Analysis (HAZOP) Potential Areas of Use(s) Manufacturing processes Equipment and facilities Evaluating process safety hazards Primarily as starter of a HACCP Operator error ( use error ) 7. Preliminary Hazard Analysis (PHA) Useful in analysing existing systems or prioritizing hazards Evaluate the types of hazards for the general product type, then the product class and finally the specific product Most commonly used early in the development of a project when there is little information on design details or operating procedures; thus, it will often be a precursor to further studies 8. Risk ranking and filtering Used to prioritize manufacturing sites for inspection/audit by regulators or industry Particularly helpful in situations in which the portfolio of risks and the underlying consequences to be managed are diverse and difficult to compare using a single tool Evaluate both quantitatively-assessed and qualitatively-assessed risks within the same organizational framework 9. Supporting statistical tools Monitors critical parameters Provides information to determine Process capability, Variability and Control Some charts are dealing with warning limits or trend analysis Note: No single tool or method is appropriate for all cases. Ref: ICH Q9 Annex 1 28

4 Quality Risk Management Tool Selection Risk assessment can be done by using any of the tools mentioned above. It is a challenging exercise for Risk Management teams to select a perfect risk management tool. An efficient QRM requires flexibility in the selection of risk assessment tools. The level of effort or the tools should be used based on the level of risk potential and knowledge about the product and the process. It is important to set the standards before selecting and commencing with the risk assessment tool. The most widely used Risk Assessment tool in Pharmaceutical Industry is Failure Mode Effects Analysis (FMEA) 29

5 When to Select FMEA: QRM Tool Selection Matrix Considerations FMEA Suitability If process design /product / system knowledge is limited (early lifecycle phases) If process design /product /system knowledge is advanced (later lifecycle phases) If process design /product / system failures are easy to identify If process design /product / system failures consequences are well known If a detailed risk assessment is requiredif a quantitative risk ranking is desired If demonstration of the effectiveness of risk controls measures is required If demonstration of the implementation stages (e.g. DQ, IQ, OQ, PQ) of risk controls measures is required 30

6 FMEA: A General Overview What is FMEA? How did FMEAs Start? Application of FMEA in Pharmaceutical Industry What can FMEA do for you? When to Conduct FMEA? 31

7 What is FMEA? FMEA is an acronym for Failure Mode and Effect Analysis. It is an ongoing quality improvement process for identifying potential design and process failures and what their effect would be before any error actually happens. FMEA is a proactive inductive reasoning process used to look carefully and systematically at vulnerable areas or processes. So, basically it is an approach of thinking what could go wrong ahead of time and averting that from happening. The overall process is illustrated in the following diagram Failure Mode What could go wrong with a product or process? And how a product or process might fail? Effect What are the consequences of that failure? Analyse Find the possible causes of failures and the likelihood of failures being detected before occurrence. 32

8 Used across many industries, FMEA is one of the best ways of evaluating possible reliability problems early in the development cycle, making it easier for manufacturers to take rapid action and alleviate failure. The FDA has also endorsed FMEA as a powerful tool that can be helpful in assessing and preventing medication errors. Remember, an ounce of prevention is worth a pound of cure! 33