Challenge: A global medical device corporation engaged Beaufort to evaluate the validation status and performance of a purified water system of a recently acquired manufacturing unit.

Beaufort Solution: The Beaufort QA team conducted a comprehensive technical assessment and applied the DMAIC methodology and five Whys in order to perform and document a comprehensive root cause exercise. Concurrently, a statistical analysis was conducted on all available historical and current year performance data and we were able to determine that the system was performing as designed and in a “state of control” against our client’s process specifications. Then a process failure mode & effect analysis (FMEA) was executed in order to evaluate each risk and provide a solid base for solution development and prioritization.

Based on the information developed and working directly our client’s team (operators, lab technicians, maintenance mechanics, QA personnel, and process engineers) and the support team from its purified water system technical supplier, we designed an overall solution that addressed all of the critical/high risk technical deficiencies identified in the FMEA stage and then developed a re-validation/implementation plan that will be executed during the plant’s next maintenance shutdown. As the project progressed, all deficiencies that required immediate attention were submitted to change control and properly resolved, and a software validation master plan for the control system was developed with all its diagnostics/statistical tools fully functional. The overall project did not only provide our client with a fully compliant purified water system but it has the potential to generate significant operational savings after implementation.

Date posted: October 27, 2011

Categories: Case Studies Quality Assurance & Compliance