RISK MANAGEMENT TOOLS - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 23

TABLE 2.1 ( Continued )
Risk Management Tool Description/Attributes Potential Applications

Failure modes effects
analysis
(FMEA)/failure
modes effects
criticality analysis
(FMECA) a

• Assesses potential failure
modes for processes, and the
probable effect on outcomes
and/or product performance
• Once failure modes are
known, risk reduction actions
can be applied to eliminate,
reduce, or control potential
failures
• Highly dependent upon
strong understanding of
product, process, and/or
facility under evaluation
• Output is a relative “risk
score” for each failure mode
• FMECA is an extension to
FMEA to include the means
of ranking the criticality of
the failure mode

• Evaluate equipment and
facilities; analyze a
manufacturing process
to identify high risk
steps and/or critical
parameters

Preliminary hazard
analysis (PHA)

• Also referred to as a
screening risk assessment
• Used early in product life
cycle to examine areas of
potential risk to assist in
prioritizing resources
• It is applicable to any
activity, system, or risk
assessment application
• Usually requires additional
follow-up or in-depth
analysis

• Used early in the
development of a
process, product, or
facility design
• Precursor to other more
detailed risk analysis
• Used when there is little
information available

a Source: Final draft, quality risk management principles, and industry case studies, Product Quality
Research Institute, December 28, 2008 [9].

The quality of results of a PHA is highly dependent upon the team and leader.
It is often the case that with a PHA, additional follow-up or in-depth analysis is
required.

2.4.1.4 Example Table 2.2 presents an example of a PHA using a table to
record information. This is representative of a PHA for a batch chemical pro-
cessing step. Figure 2.3 is an example of a risk matrix that would be used in
defining level of risk. Refer to Chapter 6 for additional examples.