Annex I.8

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Annex I.8

• Risk ranking and filtering

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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
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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
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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. Knöbel, S. Marrer, Roche
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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

Probability1 rare quality events2 infrequent
quality events 3. frequent quality events
Based on J. Knöbel, S. Marrer, Roche
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I.8 Risk ranking and filtering

• Evaluation of products and processes with
  recurring quality relevant problems
• Risk assessment Risk analysis
• Analyze production problems

J. Knöbel, S. Marrer, Roche
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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. Knöbel, S. Marrer, Roche
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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. Knöbel, S. Marrer, Roche
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I.8 Risk ranking and filtering

• Evaluation of products and processes with
  recurring quality relevant problems
• Risk assessment Risk analysis
• Analyze process problems

J. Knöbel, S. Marrer, Roche
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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. Knöbel, S. Marrer, Roche
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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. Knöbel, S. Marrer, Roche
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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. Knöbel, S. Marrer, Roche
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I.8 Risk ranking and filtering
Risk Matrix (1)
Risk Ranking
Takayoshi Matsumura, Eisai
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I.8 Risk ranking and filtering
Risk Matrix (2)
Risk Filtering
Takayoshi Matsumura, Eisai