Methods and Tools

Basic
Risk Management Facilitation
Methods
 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

 Basic risk management facilitation
methods
Flowcharts

Start

Activity

Pictorial representations
Activity
of a process
Decision No Action

Yes
Breaking the process down

Result into its
constituent steps
 Basic risk management facilitation
methods
Check sheets

• Present information
in an efficient, clear format

• May be accomplished with a

simple listing of items
 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
 Basic risk management facilitation
methods
Air
Dispensing
Scale Sieving Fluidized Bed
Dryer
Granulation Air

Magnesium Blending
• Process Stearate
Sieving
mapping

Tabletting
Packaging

Coating
 Basic risk management facilitation
methods
Cause and Effect Diagrams (Ishikawa / fish bone)

Environment People Materials

Problem
statement

Equipment Measurement
System Methods
 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
 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
Environment People Materials
causes and the need for
further investigation on them
Problem
statement

Equipment Measurement
System Methods
 Basic risk management facilitation
methods
Cause and Effect Diagrams (Ishikawa / fish bone)

C. Kingery, The Six Sigma Memory Jogger II

 Basic risk management facilitation
methods
Coating Drying Milling Analytical
Temperature

Spray Rate Redrying

Pan Speed Time Temp

Milling
Gun Distance RH Screen Size Other

Temperature Air Flow Porosity Sampling

Atomizing Air Pressure Shock Cycle Mill Speed Method

Tablet
Drug
Hardness
Operator Precompressing Water Substance
Temp/RH Main Compressing Binder Age
P.S.
Operator Feeder Speed Temp Process Conditions
LOD
Training Press Speed Spray Rate
HPMC
Punch Penetration
Depth Spray Pattern • Cause and Effect
Methoxyl
Tooling P.S.
Plant Feed
Scrape Down
Hydroxyl
P.S. Diagram
Factors Frame LOD

Compressing
Chopper Speed Other for Tablet
Endpoint
Mixer Speed Syloid
Lactose
Raw
Hardness
Coating
Materials
Granulation
Power © Alastair Coupe, Pfizer Inc.
Time