In this case study, risk is reduced by introducing a structured and standardized approach to understand and determine the
potential likelihood of system or operator failures and the probability of any resulting defect impacting the final product
and end-user. Potential risks which are above a predefined threshold, taking into account severity and frequency of occurrence
(the later of which is modified to account for the probability of on-line detection), are considered for elimination or mitigation.
Risk documentation and communication
The risk analysis for the subject case was reviewed by an oversight committee to confirm findings and support risk-mitigation
activities. Learnings from the assessment were shared with the firm's other operations that used similar packaging equipment
and/or packaging practices. In addition, learnings from the full set of packaging-line risk assessments were captured for
consideration in future packaging line design and equipment procurement efforts.
As part of the firm's auditing activities, the corporate group responsible for periodic site audits received copies of the
risk conclusions and action plans to confirm that corrective actions were deployed effectively. The risk-assessment summaries
were maintained at the local site packaging departments for use in future troubleshooting exercises involving deviation investigations
or product complaint evaluations.
Ted Frank is with Merck & Co; Stephen Brooks, Kristin Murray,* and Steve Reich are with Pfizer; Ed Sanchez is with Johnson & Johnson; Brian Hasselbalch is with the FDA Center for Drug Evaluation and Research; Kwame Obeng is with Bristol Myers Squibb; and Richard Creekmore is with AstraZeneca.
*To whom all correspondence should be addressed, at firstname.lastname@example.org