RISK MANAGEMENT TOOLS - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 22

TABLE 2.1 Advanced Risk Management Tools

Risk Management Tool Description/Attributes Potential Applications

Fault tree analysis (FTA) a

• Method used to identify
all root causes of an
assumed failure or
problem
• Used to evaluate system
or subsystem failures one
at a time, but can
combine multiple causes
of failure by identifying
causal chains
• Relies heavily on full
process understanding to
identify causal factors

• Investigate product
complaints
• Evaluate deviations

Hazard operability
analysis (HAZOP) a

• Tool assumes that risk
events are caused by
deviations from the design
and operating intentions
• Uses a systematic
technique to help identify
potential deviations from
normal use or design
intentions

• Access manufacturing
processes, facilities, and
equipment
• Commonly used to
evaluate process safety
hazards

Hazards analysis and
critical control points
(HACCP) a

• Used to identify and
implement process
controls that consistently
and effectively prevent
hazard conditions from
occurring
• Bottom-up approach that
considers how to prevent
hazards from occurring
and/or propagating
• Emphasizes strength of
preventative controls
rather than ability to
detect
• Assumes comprehensive
understanding of the
process and that critical
process parameters (CPPs)
have been defined before
initiating the assessment.

• Better for preventative
applications rather than
reactive
• Great precursor or
complement to process
validation
• Assessment of the efficacy
of CPPs and the ability to
consistently execute them
for any process

( continued )