If it immediately popped, I feel they need to go back to the beginning. Their design controls failed horribly. It states that the test is “to ensure the balloon system does not pop in an artificial casing that mimics the stomach after 10 days of placements.”. It also states that its removed after 6 mos. Why not test for 6 mos or even longer than 6 mos if its going to be in place for that long? They probably didn’t even consider decay and the stomach is a very acidic environment.

When revising the Gantt chart, the project manager needs to account for them going through most, if not all, of the nine design controls again. This project requires new inputs and outputs and this will have an impact on everything after that.