The document outlines fundamental methods for quality risk management in pharmaceuticals, including tools such as flowcharts, check sheets, process mapping, and cause-and-effect diagrams. These techniques facilitate risk identification and understanding of complex processes related to drug manufacturing. Additionally, it emphasizes the importance of accurately defining problem statements to identify root causes effectively.

1. Quality Risk Management
Basic
Risk Management Facilitation
Methods
Presentation complied by Drug Regulations – a not for
profit organization from publicly available material
form FDA , EDQM . WHO and similar organizations.
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Pharmaceuticals.
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2.  Flowchart
 Check Sheets
 Process mapping
 Cause and Effect Diagrams (Ishikawa / fish bone)
They might be helpful to support risk identification
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3. Flowcharts
Start
Activity
 Pictorial
Activity
representations
of a process
Decision No Action
Yes  Breaking the process
Result down into its
constituent steps
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4. Check sheets
 Present information
in an efficient, clear
format
 May be accomplished
with a simple listing of
items
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5. 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
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6. Ai
Dispensing
r
Scale Sieving Fluidized
Bed Dryer
Granulation Air
 Process Magnesium
Stearate
Blendin
g
mapping Sieving
Tabletting
Packagin
g
Coating
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7. Cause and Effect Diagrams (Ishikawa / fish bone)
Environment People Materials
Problem
statement
Equipment Measurement Methods
System
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8. 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
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9. 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
Environment People Materials
further investigation on them Problem
statement
Equipment Measurement
System Methods

10. Cause and Effect Diagrams (Ishikawa / fish bone)
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11. 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
Cause and
Training Press Speed Spray Rate
Punch Penetration
Spray Pattern
HPMC

Effect
Depth
Methoxyl
Tooling P.S.
Hydroxyl
Diagram
Plant Feed P.S.
Scrape Down
Factors Frame LOD
Compressing
Chopper Speed Other
for Tablet
Hardness
Mixer Speed Syloid
Lactose
Endpoint Raw
Coating
Materials
Power
Granulation
Time
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