Biomedical Engineering Reference
In-Depth Information
Inductive risk assessment is forward looking and considers planned activities.
This approach tries to predict risk in a proactive manner. Examples of events
where this is appropriate include transfer from design to production, scale-up
of the production, changing materials, or processes, or a move of the facility
or production line. The purpose of deductive risk assessment is to identify the
cause of quality issues to reduce associated risks. Examples of events where this
is appropriate include sudden change in yield, contamination event, or regulatory
mandate. The most common scenario where performing an inductive and deduc-
tive risk assessment would be an event requiring assessment of what went wrong
(look back), but a full assessment is necessary to consider what else might go
wrong (look forward).
There are many risk analysis/assessment tools that can be used for your risk
assessment process. Table 2.1 lists many of the common risk management tools.
The following sections discuss many of the major tools that are included in
the table. However, this is not to be considered a complete list of tools that are
available. The objective is to discuss many of the most common tools that
are available.
2.4.1 Preliminary Hazard Analysis (PHA)
2.4.1.1 Description A preliminary hazards analysis (PHA), also called a scree-
ning risk assessment , is a tool that requires experience or knowledge of a hazard
to identify future hazards, hazardous situations, and events that might cause harm.
The tool identifies potential hazards or hazardous events, and ranks those events,
considering the possibility of a hazard or hazardous event occurring, and their
severity (qualitatively) and identifies safeguards. This tool might be helpful when
there is little information available or in the early development of a process,
product, or facility design. This tool is often a precursor to other more detailed
risk analysis. However, the PHA has input to every aspect of the quality risk
management process as shown in Figure 2.2. The tool can be used early in product
life cycle to examine areas of potential risk to assist in prioritizing resources. PHA
is typically used as a high-level tool early in the life of a project, product, process,
or device [2,3]. Additional references defining in more detail how to conduct a
PHA are listed at the end of the chapter.
2.4.1.2 Benefits A PHA can be performed by small teams. It is applicable to
any activity, system, or risk assessment application. During the early product
development stages, a PHA is easy to implement as it allows modifications to be
made with less effort, thus reducing surprises and decreasing development and
design time.
2.4.1.3 Limitations It is necessary to have the ability to foresee hazards and
identify them for a PHA. Without having the knowledge and experience from
persons involved with the process, hazards are not easily identified. In addition,
it is difficult to identify the interaction of hazards to each other using this tool.
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