Risk management

1. PRINCIPLES 1.1 Objectives and advatages of risk management 1.2 Regualtory environment 1.3 Science-based approach 2. THE RISK MANAGEMENT PROCESS 2.1 Risk fields 2.2 Prerequisite 2.3 Knowledge and experience 2.4 Elements of risk management 2.5 Implementation of a risk management process 3. RISK MANAGEMENT AND QUALITY MANAGEMENT SYSTEM 3.1 Application to the QM system 3.2 Implementation of risk management vis the QM system 4. METHODS OF RISK MANAGEMENT 4.1 Application areas of selected methods 4.2 Preparation using a fishbone diagram 4.3 Informal method 5. FAULT TREE ANALYSIS (FTA) 5.1 Objectives and areas of application 5.2 Process 5.3 Prerequisites for an FTA 5.4 Execution of an FTA 5.5 Advantages and disadcantages of an FTS 6. FAILURE MODE EFFECTS ANALYSIS (FMEA) 6.1 Objectives and areas of application 6.2 FMEA process 6.3 Further parameters for assessment of the overall 6.4 Implementation of FMEA in the company 6.5 Advantages and disadvantages of an FMEA 6.6 Application example of a modified 7. APPLICATION EXAMPLE OF A COMBINED FTA AND FMEA 7.1 Step 1: team formation and working method 7.2 Step 2: discussion of the process and identification of the risk 7.3 Step 3: risk evaluation and acceptance 7.4 Step 4: risk control 7.5 Step 5: further measures and verification 8. HAZARD ANALYSIS OF CRITICAL CONTROL POINTS (HACCP) 8.1 Prerequisite and result 8.2 Execution 8.3 Advantages and disadvantages 8.4 Application example ICH Q9 - QUALITY RISK MANAGEMENT 1. Introduction 2. Scope 3. Principles of quailty risk management 4. General quality risk management process 5. Risk management methodology 6. Integration of quality risk management into industry and regulatory operations 7. Definitions 8. References Annex I: Risk Management Methods and Tools Annex II: Potential Applications for Quality Risk Management