The risk analysis
The assessment effort required that potential product defects from any given packaging operation be defined and graded for
severity, frequency, and on the ability of the operation and/or an operator to detect the defect. Tables I and II summarize
the definitions and categories applied for severity and frequency. Defect detection was categorized and graded on a 0-to-4
scale to reflect a detection capability of "none" (unable to detect) to "always" detect.
Table I: Sample severity categories.
A team of packaging subject-matter experts, and local site packaging engineers familiar with the subject packaging lines under
assessment, worked to collect relevant data about the packaging line. All operations involved with the line function (e.g.,
equipment, procedures) were listed and all corresponding potential failures were then listed. For each potential failure,
the team worked to understand its potential impact on packaging operations and then worked to assign a severity category.
Following severity classification, the team reviewed the dominant causes relevant to the defined potential failure and assigned
each a frequency category.
For each potential failure, all safeguards (e.g., detection capabilities) were reviewed and a detection capability was assigned.
For determinations of severity, frequency, and detection, all relevant data was taken into consideration, to include maintenance
and operation logs, batch records, deviation investigations, customer complaint records, and so forth.
Table II: Sample frequency categories.
In the FFEA model, the calculated frequency (F) is combined with the ability to detect (D) and then plotted against severity
(S) as follows:
The resulting work output from this assessment was recorded in tabular form. Table III shows an excerpt of the resulting work
Table III: Resulting work product (sample).
Using the collected tabular information, a risk matrix was assembled (see Figure 1). In Figure 1, items A through D from Table
III are noted to reflect their calculated frequency. The risk matrix helps to visually prioritize the results from the risk
analysis. In this case study, item "A" would get immediate action to eliminate or reduce the risk. Items "B" and "D" would
be evaluated and actions would be taken if practical and appropriate to reduce or eliminate risk. No actions would be required
for item "C".
Figure 1: Risk matrix.