Annex I: Methods & Tools
ICH Q9 QUALITY RISK MANAGEMENT
Annex I.8
Risk ranking and filtering
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance
July 2006, slide 1
Annex I: Methods & Tools
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
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 2
Annex I: Methods & Tools
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
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance
ICH Q9
July 2006, slide 3
Annex I: Methods & Tools
ICH Q9 QUALITY RISK MANAGEMENT EXAMPLE
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 1999-2002 > Complaints 2000-2002 > Investigation Reports 2000-2002 > Recalls 2000-2002 > Additional information from manufacturer considered
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 4
Annex I: Methods & Tools
ICH Q9 QUALITY RISK MANAGEMENT EXAMPLE
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
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
Annex I: Methods & Tools
ICH Q9 QUALITY RISK MANAGEMENT EXAMPLE
I.8: Risk ranking and filtering
Evaluation of products and processes with recurring quality relevant problems
Risk assessment: Risk analysis
Analyze production problems
Site A B C A Product name ABC ACB BAC CAB Type of recurrent problem/defect Broken units Broken tablets Melt backs during lyophilization Foreign particles
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 6
Annex I: Methods & Tools
ICH Q9 QUALITY RISK MANAGEMENT EXAMPLE
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
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 7
Annex I: Methods & Tools
ICH Q9 QUALITY RISK MANAGEMENT EXAMPLE
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
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 8
Annex I: Methods & Tools
ICH Q9 QUALITY RISK MANAGEMENT EXAMPLE
I.8: Risk ranking and filtering
Evaluation of products and processes with recurring quality relevant problems
Risk assessment: Risk analysis
Analyze process problems
Process Printing of Variable Data Products concerned ABC ACB BAC CAB CBA Blister: blister foil peels off ABC ACB BAC CAB
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 9
Annex I: Methods & Tools
ICH Q9 QUALITY RISK MANAGEMENT EXAMPLE
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
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 10
Annex I: Methods & Tools
ICH Q9 QUALITY RISK MANAGEMENT EXAMPLE
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
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 11
Annex I: Methods & Tools
ICH Q9 QUALITY RISK MANAGEMENT EXAMPLE
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
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
Annex I: Methods & Tools
ICH Q9 QUALITY RISK MANAGEMENT EXAMPLE
I.8: Risk ranking and filtering
Risk Matrix (1) Severity
Medium
Risk Ranking
Probability
High
High
Low
Risk Class ONE
Risk Class TWO Risk Class THREE
Medium
Low
Takayoshi Matsumura, Eisai
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 13
Annex I: Methods & Tools
ICH Q9 QUALITY RISK MANAGEMENT EXAMPLE
I.8: Risk ranking and filtering
Risk Matrix (2) Detection
Medium
Risk Filtering
Risk Classification
ONE
High
Low
HIGH priority MEDIUM priority LOW priority
TWO
THREE
Takayoshi Matsumura, Eisai
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance July 2006, slide 14
