In project management it is important to develop a project management plan, Risk management plan, and some type of design input document. In a design development plan what should it contain and why is it important to the project to have these components.
According to ISO13485, a design development plan is a tool used to control the design process and it is usually updated throughout the entire project. Some of the important features of the design development plan are the Gantt Chart, budget, and schedule (and many more). Although all features of a design development plan are important, I wanted to point out these three components because they are essential for the smooth running of a project. The Gantt Chart and schedule both provide a timeline of what needs to be completed by a certain time and what deliverables are required. Gantt Charts provide a more detailed schedule indicating specific tasks that need to be completed and their dependencies. In other words, a Gantt Chart not only tells the project team what needs to be done, but also what needs to be completed prior to initiating another task. Gantt Charts and schedules in the design development plan keep the project team on track to completing the project in time. The budget is also super important because it allows for each department to keep track of what they’re spending and how much they have left to spend to ensure they’ll have enough money to complete their tasks. Staying on schedule and within budget are two extremely important components of a successful project, which is why including these components in the design development plan is essential.
Some important factors that should be in a Design Development plan is
- The timing for the product design because this gives an idea of how long the design will take
- The resources needed for the project as well as allocation because it would give an idea of what the budget would look like.
- Individual responsibility for set task as well as criteria because this would give each task to a specific person/department so everyone knows what they must complete
The plan can include more specific tasks but these three cover the main points in a development plan.
In addition to what has been mentioned in the prior posts, it is important for the Design and Development Plan to include verification and validation, as well as traceability through the design process. The validation is important to the design and development plan as a way of determining the design has addresses all of the given requirements by the customer. Likewise, the verification is important to check that the inputs for the design equals the design outputs. Both verification and validation are needed as they are extremely important in determining that the product actually meets what the customers has requested. A design traceability matrix is a good way of keeping record of the validation and verification through out the design process. This matrix links the design inputs, design outputs, risks, and verifications. Properly documenting these aspects of the design process in the design and development plan will help create a more smooth and successful design process altogether.
To add to what has already been mentioned, it is also important to include the work breakdown structure (WBS) and WBS dictionary in the design development plan. Design controls are an important part of the project, but from a project management side, the people doing each task need to understand how each task will be accomplished and by who. This project management document is vital to the success of the project because it makes the huge project more manageable and approachable. Having it available from the beginning of the project complements the Gantt chart and schedule and it is a great reference for the personnel on the team.
As previously mentioned, a design development plan is necessary to have the project run smoothly. Each of the components contribute to some aspect of the project to allow for all members of the team to understand what needs to get done and when it needs to get done. In addition to the items mentioned by others in this thread, such as the preliminary Ghantt chart, the work breakdown structure (WBS) and dictionary, and budget, a network diagram is also an essential component in the design development plan. A network diagram helps the team visualize the tasks and activities that need to be completed over the duration of a project and gives information such as task duration, sequence, and dependency, hence why it is important for all members of the team to familiarize themselves with it. These are similar to Ghantt charts in terms of information, but differ because of how the information is presented, which is a flow chart. This flowchart design showcases the the sequential workflow of project tasks and are great for planning because they help the project manager and members of the team identify what tasks are necessary for other tasks to be completed. They are also beneficial because they clearly showcase what is happening in the project in a concise design that can be presented to people outside of the project team such as stakeholders or other upper management.
In project management it is important to develop a project management plan, Risk management plan, and some type of design input document. In a design development plan what should it contain and why is it important to the project to have these components.
The design development plan should include the budget, a product design schedule, and tasks that must be completed. Without these three main components in the design development plan, one can have severe downfalls in creating a device. For example, if the budget is not known, the product can be way too expensive for the market, leading to low margins. Also, if the correct schedule is not created, no one will be on the same page, leading to miscommunications. Lastly, the tasks which must be completed should be included in the schedule, so all departments are on the same track. The reasons above are why the design development plan is essential to creating a product.
The components of a Design and Development Plan (DDP) are defined in ISO 13485. Two main aspects of the DDP are drafting the overall plan and objectives of the project and to approve it using design controls. Further, throughout the duration of the project the DDP can be revised multiple times to account for updates and changes in the project. To be more specific on the first aspect, the first component of the DDP should be the objective or purpose of the project/product. Next component should include the listing of the different departments that have a role in the project. There should be a broad overview of the risk management process that will be done for the product. Both the design inputs and outputs should also be listed, the outputs can only be listed later on the project lifecycle in a later revision. Design Verification and Validation should also be mentioned as separate sections. Resource allocations, criteria for fulfilling each tasks, and a preliminary schedule should also be included.
An important note is that the DDP will be updated and revised as the project progresses.
The Design and Development Plan (DDP), as defined by ISO 13485, contains the objectives as @DevDesai pointed out, as well as the assignees and timelines as @veron_perez mentioned. Additionally, as the sample project DDP included, additional definitions of design controls and interfaces must be elucidated as it helps dictate the progression of the project and the how the inputs from each team member are considered.
I believe the best way to think about the Design Development Plan is as a complete lay out of blueprint of the project. The basic documentation and planning such as the Gantt chart (prelimary gantt chart also) describing the tasks and responsibilities required by the project members is a vital blueprint to the project. Similarly, the schedule and project sub plans also assist with keeping the project process on track and ensuring all tasks are completed within different realms of the overall project. I believe most companies would require this to be completed before the actual project is initiated because this is the main lay out of the details within the project that can prove that the preliminary planning is been conducted to standards.
As discussed during lecture, the Design Development Plan should contain the Gantt Chart, WBS dictionary, Network Diagram, the budget, schedule, resources, and all other project sub-plans. The sub-plans include the Project Charter, Scope Management Plan, Communications Plan, Quality Plan, and the Risk Management Plan. Each of these components are essential to project management planning as all components contribute to the progression of a project and project inputs.
A work breakdown structure (WBS), Preliminary Gantt chart, timeline, resources, planning of tasks and budgets, etc, are very necessary for a design development plan.
The requirements associated with the Design and Development Plan according to ISO 13485:2016 are reported in section 7.3.2. Basically, the Design Plan is considered a tool for the control of the design process and it shall be updated throughout the whole process. There are specific requirements for what shall be included in the plan:
- Stages of the design process
- The reviews needed at each stage
- The verification, validation, and design transfer activities
- The responsibilities and authorities for design and development
- Methods to ensure traceability between design and development outputs and outputs
- The resources needed, including the necessary competence of personnel
