Team selection is also key to the success of a risk assessment. The team must be crossfunctional and represent the appropriate
areas as defined by the scope. The team used for the process validation case study included individuals from four departments:
validation, process development, quality, and manufacturing. This provided the necessary subject matter expertise to understand
the details of running the manufacturing equipment and the design of the process.
Selecting a Risk Analysis Tool
One of the final items defined in the initiation phase is selecting a risk analysis tool. The tool will dictate the structure
used throughout the risk assessment phase. The choice of tool depends on the logic of the tool and the amount of information
and data are available.
The logic of the tool relates to how failure is viewed in the context of time. If the logic of a tool is designed to look
forward in time, the tool will be designed to answer the question, "What would happen if this failure occurred?" This type
of reasoning is inductive, and examples of inductive risk analysis tools include Preliminary Hazard Analysis, Failure Mode
Effect Analysis, and Event Trees.
If the logic of the tool is to look back in time, the question being answered is, "What caused this issue or failure to happen?"
This is deductive reasoning and a tool that supports this type of logic is a Fault Tree Analysis. In this process validation
case study, a tool that looks forward in time was the best choice. The goal was to look at the types of failures that could
occur and list the product quality consequences of each potential failure's occurrence.
Once a tool with an inductive reasoning approach has been chosen for the risk assessment, the amount of available information
and data must be considered. If the risk assessment will be performed on a process that has not been well defined, or if only
limited information is available, a tool that requires a lot of detail for execution would not be appropriate. In such a case,
a Preliminary Hazard Analysis, which only requires limited information, may be the most appropriate tool.
Such a tool would not make sense, however, for evaluating a process validation protocol. At the point a validation protocol
is written, a very detailed level of understanding is assumed to exist through extensive process characterization work and
large scale shake-down runs of the process equipment. Therefore, an inductive risk analysis tool that is designed to handle
a well-defined process is needed. In addition, the tool must be able to capture the known or potential failures for the process
as defined in the scope and identify the impact of failure. A number of tools fit this description. One such tool is a Failure
Mode Effect Analysis (FMEA). More in-depth comparisons of available risk analysis tools appear in the literature. 5,7,9,10
A process FMEA begins by defining the scope of the process to be evaluated. This can be done easily by using a process map.
As noted in the discussion of the initiation phase, the scope is narrowed further by listing items that do not fall within
the analysis, according to the assumptions made for the analysis. For example, raw materials were not part of this risk analysis,
and it was assumed that the raw materials met established specifications. This in-scope–out-of-scope exercise typically is
completed by the leader of the risk assessment process and is shared with the team. It is helpful to complete an "FMEA start
up worksheet" to organize the pre-work. McDermott, et al., propose an example of such a sheet.8 Additional pre-work required for an FMEA is developing the scales to be used in the analysis and the action threshold to
be used for the gap analysis or risk evaluation component of the risk assessment phase.
Table 1. Steps to execute a Failure Mode Effect Analysis.