RISK MANAGEMENT TOOLS - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 41

TABLE 2.7 Basic Risk Management Tools

Risk Potential

Management Tool Description/Attributes Applications

Diagram analysis a
• Flowcharts
• Check sheets
• Process mapping
• Cause/effect
diagrams

• Simple techniques that are
commonly used to gather
and organize data,
structure risk management
processes, and facilitate
decision-making

• Compilation of
observations, trends, or
other empirical
information to support a
variety of less complex
deviations, complaints,
default, or other
circumstances

Risk ranking and
filtering a

• Method to compare and
rank risk
• Typically involves
evaluation of multiple
diverse quantitative and
qualitative factors for
each risk, and weighting
factors and risk scores

• Prioritize operating areas
or sites for
audit/assessment
• Useful for situations when
the risk and underlying
consequences are diverse
and difficult to compare
using a single tool

5 Why analysis

• The technique of
repeatedly asking “why”
something occurred

• Facilitates the
identification of deep
underlying causes of
problems and failures

Histograms • Summarizes the frequency

distribution of the data set

• Used in decision-making
by identifying outliers of
data from a risk
assessment

Pareto analysis • Technique for prioritizing

information under the
principle that 80% of the
problems are produced by
20% of the causes

• Useful in identifying
hazards that have the most
impact to reducing risk

Control charts

• A tool used to determine
whether or not a process
is in a state of statistical
control

• Used for risk mitigation
or monitoring

a Source: Final Draft, Quality Risk Management Principles and Industry Case Studies, Product Quality
Research Institute, December 28, 2008 [9].

2.5.4 Cause and Effect Diagrams (Fishbone or Ishikawa Diagram)
Cause and effect diagrams (also known as fishbone or Ishikawa diagrams) assist
in identifying whether the cause of failures were hazards. The main branches of
the diagram represent categories of contributing causes. This facilitation tool is
beneficial for associating multiple possible causes with a single effect.