Validation Center™

In November, 2005, The ICH organization published this guideline for applying risk management processes to quality subjects.  This document explains the basic concepts of risk management, risk assessment, and risk control.  It also provides a comprehensive overview of many of the common risk management tools and methods, including FMEA, fault-tree analysis, HACCP, and HAZOP.  See Annex II section 4, for suggestions on where to apply risk management to computer systems.