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A key early step in the execution of a risk analysis is to determine the appropriate risk-assessment tool, or methodology.
There is no single best choice for any given assessment process, and the selection of the appropriate risk methodology should
be based on the depth of analysis required, complexity of the subject risk of concern, and the familiarity with the assessment
tool. Based on the industry examples reviewed by the PQRI–MTC working group, risk ranking and filtering (sometimes referred
to as risk matrix) and flowcharting were the most popular tools used for basic risk-assessment activities. Correspondingly,
failure-mode effect analysis (FMEA) appeared to be the most frequently used methodology for more advanced risk analysis. Some
examples demonstrated the power of combining tools to help with more complex analysis. For example, fault-tree analysis (FTA)
or a fishbone diagram can be used to initially scope and evaluate the fault modes of a particular problem and be used to feed
a hazards analysis and critical control point (HACCP), or a similar tool to evaluate overall system control and effectiveness
can be used. Table I provides a list of generally well-recognized risk-management tools.
Table II: Severity categorization.
Each risk subject and assessment warrants consideration of the applicable descriptors of potential risk and related consequences.
Ideally, firms should establish a guidance document ahead of any risk analysis, such as the one provided in Table II, to help
guide the risk-assessment process and provide for consistency in decision-making company-wide.
Risk trainers. In assembling this collection of case studies, the authors recognized the benefit of providing industry with additional background
on core risk methodologies. Training tools for the application of risk ranking and filtering, FMEA, FTA, and HAZOP are available
online with the web version of this article at
http://PharmTech.com/PQRIstudies. These tools are meant to facilitate greater familiarity with the risk methodology used in each corresponding case study.
