Quality Risk Management Handbook Conducting FMEA Using the Sartocheck^® 5 Plus Filter Tester

Failure Modes and Effects Analysis are commonly used techniques for risk management where simple quantification of risk is insufficient and where identification of root causes of risks and means of mitigation are paramount. This handbook guides you on how to comply with ICHQ9 and the revised Annex 1 with filter integrity testing by:

1. Defining hazards, reducing and improving the probability of detectability, regardless of the integrity device you use

2. Improving operator safety (HSE / OSH)

3. Setting up program-specific parameters for automatic detection of operating errors