RISK MANAGEMENT TOOLS - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 36

HACCP example

Identify preventive
measures that reduce
the likelihood of
occurrence of the
hazard to ensure that
control at this step is
not necessary

The step
is not a
critical
control
point (CCP)

Does this step involve
a hazard of sufficient
risk or severity to
warrant its control?

Is control at this step
necessary to prevent,
eliminate, or reduce the risk
of the hazard to an
accepatable level?

Indicate at which
other step control
will be
implemented

The step
is not a
CCP

The step is a
CCP

Figure 2.9 Simple example of a HACCP.

2.4.7.1 Layer of Protection Analysis (LOPA) Layer of protection analysis
(LOPA) is a more simplified risk assessment tool that provides more information
than the traditional qualitative process hazard analysis. It provides a semiquan-
titative risk assessment that looks at the effectiveness of individual protection
layers and then combines the protection layers to evaluate against risk criteria.
LOPA is not a hazard identification technique. It is necessary to identify the
hazards from another tool such as HAZOP. LOPA provides a semiquantitative
risk analysis, which is beneficial when there is a concern that a qualitative risk
analysis may be insufficient. A LOPA may be more cost-effective and less time
consuming than other quantitative risk analysis tools. LOPA does not identify
hazards. It is used with other risk assessment tools.

2.4.7.2 Event Tree Analysis (ETA) Event tree analysis (ETA) is similar to
FTA, but starts with the initiator and expands to the consequences (fault trees
start with the effect and drill down to causes). ETA is an inductive analysis that
determines all possible outcomes from an event. In a complex system, an ETA is