Risk Management is a new approach for both regulatory authorities and industry.

It is an effort to look systematically at the critical steps of a process by using established methods of risk analysis, e.g. FMEA or HACCP. With the publication of the ICH Q9 in November 2005 risk management became an intensive discussed topic worldwide. The implementation of risk management in a company promises to select between significant and less important steps and thereby reduce the efforts to an acceptable minimum.

Apart from describing content you will find many tables, examples, forms, which can be used in the daily practice.

Table of contents:
- Risk Management Process
- Risk Management and Quality Management System
- Methods of Risk Management
- Fault Tree Analysis (FTA)
- Failure Mode Effects Analysis (FMEA)
- Application example of a combined FTA an FMEA
- Hazard Analysis of Critical Control Points (HACCP)
- ICHQ9 Quality Risk Management

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Mario Hertlein
Andreas Kaßube
Dr. Thomas Linz
Frank Till