I was working on a project to requalify all of the components that were used for a cardiopulmonary device, and one of the tasks that was overlooked in the planning phase were all of the packaging that was used. Simple things like protective cardboard that the wrapped, sterile devices were shipped in became a big task to qualify due to the number of vendors that were used worldwide. Further delays were caused by the unavailability of packaging engineers. As a result, the task was added to the critical path and completion of the project was delayed.