Annex I: Methods & Tools prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 1 ICH Q9 QUALITY RISK MANAGEMENT Annex I.8 Risk ranking and filtering
Annex I: Methods & Tools prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 2 ICH Q9 QUALITY RISK MANAGEMENT I.8: Risk ranking and filtering Compare and prioritize risks How to perform? Requires evaluation of multiple diverse quantitative and qualitative factors for each risk Involves breaking down a basic risk question into as many components as needed to capture factors involved in the risk These factors are combined into a single relative risk score that can then be compared, prioritized and ranked ICH Q9
Annex I: Methods & Tools prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 3 ICH Q9 QUALITY RISK MANAGEMENT I.8: Risk ranking and filtering Potential Areas of Use(s) To prioritize manufacturing sites for inspection/audit by regulators or industry Helpful in situations in which the portfolio of risks and the underlying consequences to be managed are diverse and difficult to compare using a single tool Useful when management needs to evaluate both quantitatively and qualitatively assessed risks within the same organizational framework ICH Q9
Annex I: Methods & Tools prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 4 ICH Q9 QUALITY RISK MANAGEMENT I.8: Risk ranking and filtering Evaluation of products and processes with recurring quality relevant problems Risk assessment: Risk identification >recurring quality relevant problems within production and/or processes Risk assessment: Risk analysis Footing on an analysis of >Production problems >Complaints >Investigation Reports >Recalls >Additional information from manufacturer considered EXAMPLE J. Knöbel, S. Marrer, Roche
Annex I: Methods & Tools prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 5 ICH Q9 QUALITY RISK MANAGEMENT I.8: Risk ranking and filtering Evaluation of products and processes with recurring quality relevant problems Risk assessment: Risk evaluation Three columns based on a classical approach by multiplying factors Probability 1: rare quality events 2: infrequent quality events 3. frequent quality events Probability R e s o u r c e s EXAMPLE Based on J. Knöbel, S. Marrer, Roche
Annex I: Methods & Tools prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 6 ICH Q9 QUALITY RISK MANAGEMENT I.8: Risk ranking and filtering Evaluation of products and processes with recurring quality relevant problems Risk assessment: Risk analysis Analyze production problems EXAMPLE J. Knöbel, S. Marrer, Roche
Annex I: Methods & Tools prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 7 ICH Q9 QUALITY RISK MANAGEMENT I.8: Risk ranking and filtering Evaluation of products and processes with recurring quality relevant problems Risk assessment: Risk evaluation Risk evaluation added to production problems EXAMPLE J. Knöbel, S. Marrer, Roche
Annex I: Methods & Tools prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 8 ICH Q9 QUALITY RISK MANAGEMENT I.8: Risk ranking and filtering Evaluation of products and processes with recurring quality relevant problems Risk assessment: Risk Control Risk control actions added to production problems EXAMPLE J. Knöbel, S. Marrer, Roche
Annex I: Methods & Tools prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 9 ICH Q9 QUALITY RISK MANAGEMENT I.8: Risk ranking and filtering Evaluation of products and processes with recurring quality relevant problems Risk assessment: Risk analysis Analyze process problems EXAMPLE J. Knöbel, S. Marrer, Roche
Annex I: Methods & Tools prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 10 ICH Q9 QUALITY RISK MANAGEMENT I.8: Risk ranking and filtering Evaluation of products and processes with recurring quality relevant problems Risk assessment: Risk evaluation Risk evaluation added to process problems EXAMPLE J. Knöbel, S. Marrer, Roche
Annex I: Methods & Tools prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 11 ICH Q9 QUALITY RISK MANAGEMENT I.8: Risk ranking and filtering Evaluation of products and processes with recurring quality relevant problems Risk assessment: Risk Control Risk control actions added to process problems EXAMPLE J. Knöbel, S. Marrer, Roche
Annex I: Methods & Tools prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 12 ICH Q9 QUALITY RISK MANAGEMENT I.8: Risk ranking and filtering Evaluation of products and processes with recurring quality relevant problems 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 EXAMPLE J. Knöbel, S. Marrer, Roche
Annex I: Methods & Tools prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 13 ICH Q9 QUALITY RISK MANAGEMENT Low Medium High Severity Probability High Low Medium Risk Class ONE Risk Class TWO Risk Class THREE Risk Ranking I.8: Risk ranking and filtering Risk Matrix (1) EXAMPLE Takayoshi Matsumura, Eisai
Annex I: Methods & Tools prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 14 ICH Q9 QUALITY RISK MANAGEMENT THREE TWO ONE Detection Risk Classification HighLowMedium HIGH priority MEDIUM priority LOW priority Risk Filtering Risk Matrix (2) I.8: Risk ranking and filtering EXAMPLE Takayoshi Matsumura, Eisai