Transcript ICH Q9 Quality Risk Management

Annex I: Methods & Tools
ICH Q9 QUALITY RISK MANAGEMENT
Annex I.1
Basic
Risk Management
Facilitation
Methods
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.1: Basic risk management facilitation methods
 Flowchart
 Check Sheets
 Process mapping
 Cause and Effect Diagrams (Ishikawa / fish bone)
They might be helpful to support risk identification
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.1: Basic risk management facilitation methods
Flowcharts
Start
Activity
 Pictorial representations
of a process
Activity
Decision
Yes
Result
No
Action
 Breaking the process
down into its
constituent steps
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance
July 2006, slide 3
Annex I: Methods & Tools
ICH Q9 QUALITY RISK MANAGEMENT
I.1: Basic risk management facilitation methods
Check sheets
 Present information
in an efficient, clear format
 May be accomplished with
a simple listing of items
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
I.1: Basic risk management facilitation methods
Process mapping
 The indicators may be selected based on unit operations
 Shows how they are interrelated
Potential Areas of Use(s) / outcomes
 Provides a clear and simple visual representation
of involved steps
 Facilitates understanding, explaining and systematically
analyzing complex processes and associated risks
 A pre-requisite for the use of some other tools
ICH Q9
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance
July 2006, slide 5
Annex I: Methods & Tools
ICH Q9 QUALITY RISK MANAGEMENT
EXAMPLE
I.1: Basic risk management facilitation methods
Air
Dispensing
Fluidized Bed
Dryer
Sieving
Scale
Granulation
 Process
mapping
Magnesium
Stearate
Air
Blending
Sieving
Tabletting
Packaging
Coating
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance
F. Erni, Novartis Pharma
July 2006, slide 6
Annex I: Methods & Tools
ICH Q9 QUALITY RISK MANAGEMENT
I.1: Basic risk management facilitation methods
Cause and Effect Diagrams (Ishikawa / fish bone)
Environment
People
Materials
Problem
statement
Equipment
Measurement
System
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance
Methods
July 2006, slide 7
Annex I: Methods & Tools
ICH Q9 QUALITY RISK MANAGEMENT
I.1: Basic risk management facilitation methods
Cause and Effect Diagrams (Ishikawa / fish bone)
 To associate multiple possible causes with a single effect
 Constructed to identify and organize possible causes for it
 Primary branch: represents the effect
 Major branch:
corresponds to a major cause
 Minor branch:
correspond to more detailed causal factors
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
I.1: Basic risk management facilitation methods
Cause and Effect Diagrams (Ishikawa / fish bone)
How to perform?
 Define and agree a precise problem statement
(put as “head” of fish bone) Think “What could be its
causes?” for each node
 Add it to the “fish bone” diagram
 For each line pursue back to its root cause
 Consider splitting up overcrowded sections “bones”
 Consider which potential root
causes and the need for
further investigation on them
Environment
Equipment
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance
People
Materials
Measurement
System
Problem
statement
Methods
July 2006, slide 9
Annex I: Methods & Tools
ICH Q9 QUALITY RISK MANAGEMENT
EXAMPLE
I.1: Basic risk management facilitation methods
Cause and Effect Diagrams (Ishikawa / fish bone)
C. Kingery, The Six Sigma Memory Jogger II
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.1: Basic risk management facilitation methods
Coating
Drying
Milling
Analytical
Temperature
Spray Rate
Redrying
Pan Speed
Temp
Time
Milling
Gun Distance
RH
Temperature
Air Flow
Atomizing Air Pressure
Operator
Temp/RH
Operator
Training
Other
Sampling
Porosity
Mill Speed
Shock Cycle
Precompressing
Main Compressing
Temp
Press Speed
Spray Rate
P.S.
Process Conditions
LOD
HPMC
Spray Pattern
Tooling
Feed
Frame
P.S.
Scrape Down
Compressing
Methoxyl
Hydroxyl
P.S.
LOD
Chopper Speed
Other
Mixer Speed
Syloid
Lactose
Endpoint
Coating
Power
Time
Tablet
Hardness
Age
Binder
Feeder Speed
Method
Drug
Substance
Water
Punch Penetration
Depth
Plant
Factors
Screen Size
Raw
Materials
Granulation
prepared by some members of the ICH Q9 EWG for example only; not an official policy/guidance
 Cause and
Effect
Diagram
for Tablet
Hardness
© Alastair Coupe, Pfizer Inc.
July 2006, slide 11