Unfortunately, the scenario previously explained happens all too often. The root cause of these situations is typically due to poor planning. The problem was initiated when management committed to a launch date prior to adequately understanding the resources, technical risk and time required to launch the product. If management had allowed the PM to adequately plan and assess the resources needed to meet project deliverables they would have had a realistic picture of what it would take to complete development of the device prior to committing resources. A design and development plan also would have prevented confusion of project assignments between team members and would have minimized the potential for late deliverables.
A design and development plan is both a planning tool and a communication tool between management and the development team. Instead of management having to hear about project issues through the rumor mill, periodic design reviews and updates to the DDP would have effectively communicated problems with the product development as the project progressed.
Under initial review of this case study it may be tempting to point fingers at the PM as the main culprit in this scenario, but in this case the blame should also be shared with management. Yes it is true that the PM delayed the creation and approval of the DDP, but his decision to delay was based on pressure from management’s aggressive timelines. The PM was in survival mode to do everything and anything to meet the deadline. In addition, management did not convey the importance of regulatory compliance within the company so the PM also did not think it was critically important.