RISK MANAGEMENT TOOLS - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 34

2.4.5.2 Limitations It is not a good idea to use HACCP when there is little
experience with the process. HACCP is not a good tool for analyzing interactions
between failure modes or causes. This process is also limited when there is a
need to address overall process or product reliability or other risks other than for
safety and quality.
2.4.5.3 Examples Figure 2.8 presents how HACCP fits into the risk manage-
ment process. Figure 2.9 shows a simple example of decision making as part of
conducting a HACCP analysis.
2.4.6 Risk Ranking and Filtering (RRF)
2.4.6.1 Description Risk ranking and filtering (RRF), also called “risk rank-
ing,” is a tool for comparing and ranking risks. This tool is helpful for managing
a large set of diverse risks that are difficult to compare. The ranking is performed
after each identified risk factor has been assigned a composite risk score. This is
used to sort the risks relative to each other. The filtering of risks is performed by
using weighting factors, cutoff values for scores, or other criteria. This process
can be used to fit the risk ranking into management or policy objectives. The
overall process of conducting RRF includes (i) identifying risk factors (hazards),
(ii) grouping risk factors into categories, (iii) assigning a score to each risk factor,
and (iv) ranking and filtering the risk factors. Figure 2.10 shows how RRF fits
into the risk management program.
2.4.6.2 Benefits It is beneficial to use a RRF risk assessment tool when there
are many risks to be managed and they are diverse and difficult to compare.
This process can be used where both qualitative and quantitative risks are to be
managed.
2.4.6.3 Limitations RRF does not add value when the list of identified hazards
or risk factors is small, or the scope is very focused. RRF is not a good tool for
reactive/retrospectively initiated risk management processes for specific incidents.
2.4.6.4 Examples Tables 2.5 and 2.6 are examples of risk ranking and RRF,
respectively. The RRF has a cutoff where any process with a rank of > 32 will
be addressed.
2.4.7 Other Risk Analysis Tools
Although not as commonly used as the previously mentioned tools, the following
risk analysis tools are also available for the risk management process.