Planning is a key activity to support the identification of necessary man-power and technical resources and to map out an effective schedule to successfully complete product development within a specified time frame. This is particularly important when responding to emergencies where the time available to produce urgently needed equipment may be very short. An effective plan will ensure that the product goals are fully aligned with overall technical, regulatory and business requirements and will generate clarity on the effort that will be needed, and when it will be needed, to deliver a safe and reliable product which meets all the requirements.
Planning needs to be undertaken from the outset to enable potential costs and timescales to be estimated and the feasibility of achieving the project objectives within the specified budget and time constraints to be understood.
Planning should start early in product development with the plan continuously updated as the development progresses to reflect the changing activities and levels of detail required at subsequent development stages.
Planning involves identifying specific tasks that need to be undertaken to enable delivery of the device/equipment. Tasks will range from understanding requirements, checking relevant codes, regulations and standards, undertaking risk assessments to engaging with certification bodies, defining detailed design drawings/specifications, testing procedures, manufacturing procedures, quality control checks, etc.
For each task it is important to identify:
In developing the schedule, it is often sensible to start planning by considering the overall time available to deliver the final product and then to allocate time and resources needed to achieve the required delivery date. Costs can then be estimated to meet this schedule.
The order of tasks will be important, for example a detailed risk assessment will require a reasonable level of detail in relation to the design and application of the device. It will be important to identify essential requirements early on in the project as this may drive the development work, testing and risk assessments.
It is often prudent to include contingency on time and budget to allow for emergent problems - this is particularly important where the development is, or includes, a new technology.
At the top of the RAPAT “Planning” worksheet, the “Planning Sheet Completion Status” will initially be set to “Not started”. Use the dropdown list to change this to “In progress”, or “Completed” as appropriate.
Populate the “Planned activities” table, adding further tasks using the “Add Row” button as required. Separate tables are provided lower down the worksheet for identifying milestones and decision gates. The plan dashboard at the top of the worksheet automatically tracks progress against the identified tasks, milestones and schedule.
**Coming Soon** A button is provided at the top of the worksheet to generate a project Gantt chart from the list of identified tasks, schedule, milestones and decision gates. **Coming Soon*
**Coming Soon** Another button is also provided at the top of the worksheet which will create a costing table to the right-hand end of the “Planned activities” table. There is a simplified costing option for which costs can be added manually for each task in the “Planned activities” table. Alternatively, the detailed option will create a separate more detailed costing worksheet which automatically populates the task costs on the planning worksheet. Further guidance related to identifying costs can be found in the Costing Help sheet. **Coming Soon**
Early stage plans (Idea stage and concept stages) need to be simple and flexible, allowing sufficient time for ideas and concepts to evolve. Plans for prototype development, manufacture set up and production will require more detail. For some tasks, this additional detail can be captured in the “Design and Manufacture” and “Testing and Analysis” worksheets with the “Planning” worksheet capturing the high level detail.
The plan should be thought of as a living document. It should be reviewed and updated on a regular basis, as more detail becomes available, to ensure it reflects both the current project stage and device development status. The RAPAT “Gantt Chart” worksheet will need to be regenerated as part of this to ensure it reflects the updated plan, previous versions can then be deleted as long as all relevant previous information is preserved. Progress against milestones and deliverables should also be checked on a regular basis.
