Annex I.8
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance
ICH Q9
Resources
500 50 5
500 50 5
1
1000 100 10
2
2000 200 20
4
Probability 1: rare quality events 2: infrequent quality events 3. frequent quality events
Probability
Based on J. Knbel, S. Marrer, Roche
July 2006, slide 5
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance
Risk communication Providing stakeholders with the update of the overview of Risk control step
Risk Review Regularly the responsible person updates the overview to support line/senior management decisions
J. Knbel, S. Marrer, Roche
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 12
Medium
Risk Ranking
Probability
High
High
Low
Medium
Low
Medium
Risk Filtering
Risk Classification
ONE
High
Low
TWO
THREE