TABLE XVIII

Example Risk Analysis for Process Room B100

HazardSub-Factor OutcomeProbability ScoreSeverity Score
TemperatureAmbient03
Wet or dry areaWet area20
DrainPresent10
ProcessingNonprocessing00
Duration of activityLong33
Cleaning and disinfectionLow level30
Distance from final formulationMore than three steps removed01
Room occupancyMedium20
EquipmentFixed and mobile02
Environmental monitoring performanceGood10
Total scores129
  • Risk Class 1.

  • Detection method: Low.