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bb254 replied to the topic FDA Recall…Now What? in the forum Project Management Process and Medical Device Development 8 years, 2 months ago
In this scenario the type of change control which should have occurred is the ECO (engineering change order). This is when you make changes to the project after it has completed the design controls and project processes. The managers should have held design review meetings after each design control phase. Within the design review meetings the group of engineers and leads should have submitted a design change request when they were reviewing the specifications of the Mylan EpiPen and EpiPen Jr. Design Review Meetings and Design Change Requests are within the monitoring and controlling phases of the project process. However, the modifications which result in a recall can put the project back into the planning phase. Since the DDP is a living document it must be updated to include the new changes.