QUALITY RISK MANAGEMENT (QRM) TOOLKIT

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1 QUALITY RISK MANAGEMENT (QRM) TOOLKIT Amanda Bishop McFarland Senior Continuous Process Improvement Analyst Global Quality Risk Management Genzyme, A Sanofi Company

2 Disclaimers The material and perspectives offered in the presentation are solely those of the presenter, and do no reflect the views or opinions of Genzyme Corporation or Sanofi. The presenter does not receive any compensation, grants, or equity interest, or funding from any group except her employer. This presentation includes intellectual property that may belong to the presenter, to Genzyme Corporation, Sanofi and/or to third parties which is protected under the copyright, trademark and other laws of the United States of America and other countries. All rights are reserved.

3 Introduction Amanda Bishop McFarland BS, Entomology MS, Mycology Genzyme, A Sanofi Company Quality Risk Management and Contamination Control

4 Tools Matter!

7 Tool Selection in Quality Risk Management The level of effort, formality and documentation of the quality risk management process should be commensurate with the level of risk. It is neither always appropriate nor always necessary to use a formal risk management process. The use of informal risk management processes (using empirical tools and/ or internal procedures) can also be considered acceptable.

8 Risk Tool Selection: The Fine Print No single tool or method is appropriate for all cases Specific risks do not always require the same tool or method When using a tool or method the level of detail of an investigation may vary according to the risk from case to case.

9 DETERMINING TOOL FORMALITY Decision Tree

10 Risk Tool Selection Decision Tree: Question #1 Is there a procedural requirement to use a specific Risk Assessment tool? YES Use the required tool NO Continue to Question #2

11 Risk Tool Assessment Selection Decision Preparation: Tree: Question Tool Selection #2 NO Select Intermediate Tool Is the assessment of a new system, process, or product? YES Is there sufficient available information on design and processing parameters to warrant the use of an extensive risk management technique? NO Continue to Question #3 YES Select Formal Tool

12 Risk Tool Assessment Selection Decision Preparation: Tree: Question Tool Selection #3 Is the system, process, or product under assessment a high-risk or high-impact item? YES Select Formal Tool NO Continue to Question #4

13 Risk Risk Tool Assessment Selection Decision Preparation: Tree: Question Tool Selection #3 Is the system, process, or product under assessment poorly understood? YES Select Formal Tool NO Select Less-Formal Tool

14 Risk Tools and Level of Formality Tool Formality Risk Management Tool Documentation Format Formal FMEA (Failure Modes and Effects Analysis) HACCP (Hazard Analysis and Critical Control Point) FTA (Fault Tree Analysis) HAZOP (Hazard Operability Analysis) Report Intermediate PHA (Preliminary Hazard Analysis) RFR (Risk Ranking and Filtering) Report Less-formal REM (Risk Estimation Matrix) Memo to file

15 Complexity Risk Assessment Tool Formality Preliminary Hazard Analysis Hazard Analysis and Critical Control Points Failure Modes and Effects Analysis Risk Estimation Matrix Formality

16 Failure Modes and Effects Analysis (FMEA) Parameter Formality Mechanism Objective Scope Typical Use Formal FMEA Quantitative (or semi-quantitative) Identify risks requiring reduction (mitigation) and prioritize accordingly Used in multiple contexts; very adaptable to different risk strategies New or existing products, processes, or systems, risk-based decision-making

17 Hazard Analysis and Critical Control Points (HACCP) Parameter Formality Mechanism Objective Scope Typical Use Formal Qualitative HACCP Develop a monitoring program based on risk Focuses on biological, chemical, and physical hazards Environmental monitoring programs, inprocess test points, preventive maintenance

18 Preliminary Hazard Analysis (PHA) Parameter Formality Nature Objective Scope Typical Use Intermediate PHA Qualitative (or semi-quantitative) Prioritize risks for reduction through design changes (mitigation) Used early in development before significant data or controls are available New products, processes, or systems

19 Risk Estimation Matrix (REM) Parameter Formality Nature Objective Scope Typical Use Less-formal Qualitative REM Quickly determine whether risk is acceptable; risk-based decision-making 3x3 matrix; used in multiple contexts; very adaptable Change control, Tech Transfer, project-specific decisions

20 Suggestions for Tool Usage If you re working on A new project and are very early in the development process with limited data available A new project but are later in the development process with a fair amount of experience A mature process, but you are interested in developing a very thorough understanding of the risks to recommend improvements Development of a monitoring program for in-process operations, critical utilities or environmental monitoring Understanding how a piece of equipment impacts manufacturing operations A relatively insignificant or moderately significant change which is well understood A project where you need to make decisions about next steps using the risk Try PHA FMEA FMEA HACCP FMEA REM REM

21 Special thanks to: *Kelly Waldron

22 References ICH Q9: Quality Risk Management

23 QUESTIONS?

Risk Management: FDA and Industry Experience. Dan Snider, Ph.D Vice President Morgantown RD Mylan Pharmaceuticals Inc.

Risk Management: FDA and Industry Experience Dan Snider, Ph.D Vice President Morgantown RD Mylan Pharmaceuticals Inc. Disclaimer This presentation contains a summary of the opinion and perspective from