Biomedical Engineering Reference
In-Depth Information
RISK MANAGEMENT TOOLS
MARK WALKER AND THOMAS BUSMANN
This chapter provides an overview of the quality risk management methodology
to be considered for the application of quality risk management tools and pro-
cedures to identify, mitigate, and communicate risks within the pharmaceutical
and biological manufacturing industries.
In general terms, risk management is a process. In its simplest form, risk
management follows a typical quality approach.
Risk management plan
Write down what you are going to do.
Risk assessment
Do what you said you would.
Risk management report
Document what you did, what you
discovered, and what you concluded.
Risk monitoring and control plan
Determine methods for monitoring and
procedures for control.
Residual risk
Identify the risk that could not be removed
and determine whether it is acceptable.
2.1 APPLICABILITY
The tools discussed in this chapter do not represent an exhaustive or com-
plete list of all tools available within the risk management toolbox, but are a
cross-section of some of the more widely used tools. Companies may choose to
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