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Annex I.8. Risk ranking and filtering. 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

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annex i 8
Annex I.8

Risk ranking and filtering

i 8 risk ranking and filtering
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

i 8 risk ranking and filtering3
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

i 8 risk ranking and filtering4

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 productionand/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

i 8 risk ranking and filtering5

EXAMPLE

s

500

1000

2000

500

e

c

r

u

50

100

200

50

o

s

e

R

5

10

20

5

1

2

4

Probability

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

i 8 risk ranking and filtering6

EXAMPLE

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

i 8 risk ranking and filtering7

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. Knöbel, S. Marrer, Roche

i 8 risk ranking and filtering8

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. Knöbel, S. Marrer, Roche

i 8 risk ranking and filtering9

EXAMPLE

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

i 8 risk ranking and filtering10

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. Knöbel, S. Marrer, Roche

i 8 risk ranking and filtering11

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. Knöbel, S. Marrer, Roche

i 8 risk ranking and filtering12

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. Knöbel, S. Marrer, Roche

slide13

EXAMPLE

Severity

Medium

High

Low

Risk ClassONE

High

Risk ClassTWO

Medium

Probability

Risk ClassTHREE

Low

I.8: Risk ranking and filtering

Risk Matrix (1)

Risk

Ranking

Takayoshi Matsumura, Eisai

slide14

EXAMPLE

Detection

Low

Medium

High

HIGH priority

MEDIUM priority

ONE

LOW priority

TWO

Risk Classification

THREE

I.8: Risk ranking and filtering

Risk Matrix (2)

Risk

Filtering

Takayoshi Matsumura, Eisai

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