An Overview of Risk Management and Risk Analysis Techniques

In this Risk management training we will review the concept of Risk Management, its various elements, what is required, and its benefits. How are you meeting the FDA and ISO risk management requirements? Hazard Analysis? FMECA? dFMEA/pFMEA? The concept of Risk Management and the difference between risk analysis, evaluation, assessment, and management.

The various forms of risk analysis will be described, highlighting their key characteristics and objectives as well as their differences. The relationship between risk analysis methods and which ones should be used will also be covered. We will discuss examples of some of the most commonly used forms of risk analysis, explaining the techniques and terminology used, and will review who should perform them and when they should be performed. We will also discuss the evaluation and acceptability of overall residual risk. We will also review the Risk Management Plan, the Risk Management Report, and the Risk Management File.

Areas Covered in the Seminar:

• Risk analysis, risk evaluation, risk assessment, and risk management
• The benefits of risk analysis and risk management
• Description of the different risk analysis methods
• Qualitative vs quantitative risk analysis
• Hazard Analysis
• FMEA & FMECA
• dFMEA & pFMEA
• Fault Tree Analysis
• Comparison of risk analysis methods: their relationships and differences
• Residual Risk
• Risk acceptability
• Risk management planning

Who Will Benefit:

• Quality Assurance managers and personnel
• R&D managers & engineers
• Regulatory Affairs personnel
• Quality system auditors