RISK MANAGEMENT TOOLS - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 32

function. This technique can be used for analyzing hazards already identified via
other techniques. An FTA can be quantitative if data on component failure rates
are available. In addition, an FTA can reveal combinations of events leading
to failure. It is useful both for risk assessment and in developing monitoring
programs [8].
2.4.4.2 Benefits FTA is an effective tool for evaluating how multiple factors
can impact a system. It provides a visual representation of the failures, which
is useful in the analysis. An FTA can be used prospectively or retrospectively
and includes qualitative or quantitative data. It can be used in many phases of a
project, to include product development, design engineering, operations, process
expansion or modification, or as part of an incident investigation. This technique
also helps in identifying common cause events.
2.4.4.3 Limitations An FTA can be very tedious and time consuming. It
requires a fair amount of training, skill, and experience of the persons involved
in the process. An FTA is very narrow in focus.
2.4.4.4 Examples Figure 2.7 provides a simple example of an FTA for a mix-
ing motor.
2.4.5 Hazard Analysis and Critical Control Point (HACCP)
Hazard analysis and critical control point (HACCP) is a systematic, proactive risk
management tool that focuses on manufacturing processes. The process relies on
the identification of critical control points, and maintains control by operating
within critical limits to prevent hazards from occurring. There are seven steps
of HACCP: (i) conduct the hazard analysis, (ii) determine critical control points,
(iii) establish critical control limits, (iv) establish monitoring procedures and
monitor the critical control points, (v) establish corrective actions, (vi) establish
verification procedures, and (vii) establish documentation procedures and keep
records. HACCP allows flexibility on how to conduct the previously mentioned
steps. For example, HACCP states that it is necessary to establish monitoring
procedures, but it does not say what the procedures are or how often to use
them. This process is commonly used for addressing specific chemical, physical,
and biological hazards. HACCP ensures quality without relying on end-product
testing and can be used for planning ahead for correction of problems when
prevention fails [9].
2.4.5.1 Benefits It is beneficial to use HACCP when in-product testing is dif-
ficult, costly, and/or time consuming. The other advantage of HACCP is the
ability to identify potential risks early in the development or during a scale-up
of a process or product so that they can be effectively managed.