RISK MANAGEMENT TOOLS - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 43

TABLE 2.8 Risk Comparison of Risk Assessment Tools

Risk Assessment Inductive/ Interactions vs.

Tool Scope Granularity Deductive Individual Risks Complexity

PHA Any Low Either Individual Low

HAZOP Focused High Inductive Individual Medium

HACCP Any Variable Either Individual Low

FMEA Any High Inductive Individual Medium

FTA Focused High Deductive Interactions High

RRF Broad Low Inductive Individual Low

Table 2.8 compares PHA, HAZOP, HACCP, FMEA, FTA, and RRF. Granu-
larity is used in this example to indicate the level of detail that the analysis will
reach and what will show up in the documented output. As an example, the gran-
ularity of HACCP depends on what tool is selected for hazard analysis. Similarly,
HACCP does not specify the use of a particular hazard analysis technique, so it
uses either an inductive or deductive technique. There will always be exceptions
to these generalizations, but these are typical when the tools are applied in the
best way. For example, you could do a deductive/retrospective HAZOP, but that
is probably not the most effective use of the tool.

2.7 RESIDUAL RISK EVALUATION

Residual risk is the risk that remains after applying risk mitigation measures. A
residual risk evaluation looks at the risk remaining after you have performed your
risk analysis, applied risk mitigation, and implemented controls. It is important
to recognize that risk cannot be eliminated, merely reduced. An effective risk
management program must address acceptable levels of residual risk and ongo-
ing processes to continually reduce risk through improvements in processes or
procedures.

2.8 SOURCES OF RISK INFORMATION

A number of sources for supporting risk information are available. The references
listed here are sources for understanding risk management, risk analysis, risk
analysis techniques, and risk control. When executing risk analysis, the following
are typical sources for select data and information to assist in the execution of
the risk analysis.

• Published standards.
• Scientific and technical data.
• Field data.