Article on Documenting the Hazard Analysis Process Added to the Ombu Library

The Ombu Library, in the Medical Device Risk Management aisle, explains the method for documenting a Hazard Analysis using an Excel worksheet. ISO 14971:2007 (and the European variant) is a process standard that outlines a method to identify hazards and reduce the associated risks to an acceptable level. The standard requires traceability through the process. The most common approach uses an Excel workbook in which the columns represent the process steps and the rows have the analysis information for the hazard.