RISK MANAGEMENT TOOLS - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 29

2.4.3.3 Limitations Conducting a HAZOP requires a significant amount of
information and can be very time consuming. The process only considers hazards
from a single component. The process does not consider interactions between
multiple hazards. As the process only looks at single components, there is a
possibility that some likely hazards may not be identified. The process is highly
dependent upon the ability and experience of the leader and team members.

2.4.3.4 Examples Figure 2.5 shows how the HAZOP fits into the risk man-
agement program.
Table 2.4 provides an example template for conducting HAZOP analysis.
Figure 2.6 presents a process flowchart for conducting the HAZOP.

Initiate
quality risk management process

HAZOP

1. Define nodes (boundaries)

Risk assessment

Hazard identification

2. Hazard identification

Risk analysis

3. Identify causes and consequences

U
n
a
c
c
e
p
t
a
b
l
e

Risk evaluation

4. Identify safeguards

Risk control

5. Determine severity of effects

Risk reduction

6. Estimate likelihood of occurrence

Risk acceptance

7. Qualitative ranking

Output/report and
implementation

8. Recommendations

9. Implement and update

Risk review

Risk event

Figure 2.5 How the HAZOP fits into the risk management program.