I agree Communication management plan is important but thinks quality management plan is equally as important. Quality management plan monitor and verify that project deliverables meet defined quality standards. Quality assurance activities monitor and verify that the processes used to manage and create the deliverables are followed and are effective. This is essential to customer satisfaction and company success in terms of gaining more market size and profits.
DDP written by project manager is important which outlines all the developments of the project. Hence it is difficult to say one part is important in DDP. I feel all the steps involved in DDP are equally important. Communication management plan which helps to communicate people in the project is as equally important as quality management plan which monitors and enables to deliver the quality of the project.
All parts are very critical so it is difficult to say which is most important but I'd like to highlight the team member list/responsibilities section. For the project to move slowly assigning the right team members to the right role is an important way for the project to move along successfully. This makes it clear which team members you need to go to for a particular task or issue that comes up. Therefore it is important that each team member is given the responsibility for things that they are capable of and are also challenging enough for their effort.
DDPs as a whole are very crucial in the timeline of the project. The gantt chart helps to outline each segment as it is approached. The project manager must effectively build a DDP to outline all the different departments of the project. With this in mind, the communication management plan can thus be argued as one of the most important parts in order to get every member of the team on the same page. Through the DDP, a foundation can be built for the project which allows for a system of checks and balances to help the team reach its milestones efficiently.
I feel all the steps in DDP is equally important.It is difficult to say which one them has more weightage than the rest. Communication management plan helps us communicate with people involved in the project. Quality management plan helps us meet quality standards of the product set by FDA. Both are equally important to have a successfful medical device.
I think communications management plan and team list/responsibilities plan are equally important part of DDP. Communications management plan provides instructions and guidelines on who to contact and the right questions to ask to resolve an issue during the course of a project. Team list/responsibilities plan is equally important as every member in the team is required to be proficient in their own duties apart from backing up a team member in their absence. I think efficient communications plan and versatile team members makes their roles more agile and flexible and therefore contribute to the project wholly rather than strictly defined roles and responsibilities.
Hey folks:
The initiator of this topic, hg93, defines DDP as including certain named elements in an attempt to draw our attention to the fact that certain aspects used to determine the inclination of a project may be more important than others as we strive to achieve the project's 'aim' or 'objective'.
How do we measure success of a project? Only when this objective is achieved.
Early on in his lecture, Prof. Simone defined a project as follows:
A SERIES OF TASKS THAT WHEN COMPLETED CREATE A NEW OBJECT OR CAPABILITY
This is really what a project is: --- a series of tasks--- that yield something of interest.
If this simple definition is not sufficient for you, you can think of a project as being
"a collaborative enterprise, involving research or design, that is carefully planned to achieve a
particular aim. It can also be viewed as a set of interrelated tasks to be executed over a fixed
period and within certain costs and limitations"
Come to think of it, I prefer to liken a project to an AMOEBA under a microscope of several objectives able to place their focus at a given point, the amoeba for a unique (a particular) purpose.
As we already know, an amoeba is likely to go to any direction depending on its environmental factors. The several objectives of the microscope above are each specialized to detect certain aspects of its inclination; once detected the objective's (eyepiece's) reaction is automatic in creating a corrective measure designed to prevent the amoeba from going in a direction that will prevent our hitting a target.
The measure of our projects success in only when the target (aim or objective) is hit.
What I am really saying is that for our project's aim to be met, all objective of the microscope must be kept in focus on the amoeba - the project. In other words, all tools to keep our project going in right direction must be considered as important as any others. None of the tools can be more important than any of the others.
Thank you.
Andrew Disame
Design Development Plan is certainly the crucial component in a project. DDP ensure traceability of design and development outputs and inputs to design. I think the quality management plan is more important than communication plan. The quality unit has the responsibility and the authority to approve or reject all components, product elements, labeling, in-process materials, and the authority to review production records to assure that no errors have occurred during manufacturing, or if errors have occurred then, they have been fully investigated prior to continuing the process. This department is present to ensure that data are generated, documented, and reported in compliance with regulatory requirements.
The quality management plan is also an important part of DDP. The purpose of the quality management plan is to describe how quality will be managed throughout the lifecycle of the product. It also includes processes and procedure ensuring quality planning,assurance,and control are all conducted.The quality management plan creates a method for periodic review and improvement including how to handle corrective action when something goes wrong to deal with problems as well as prevent repeat occurrence . It ensures increased revenues and productivity of an organization. In order to meet customer expectation the quality management plan should be effective.
For Design Development Plan (DDP), I think the two most important parts are quality management plan and scope management plan. Because the quality management plan will tell you how to evaluate the difference between the actual outcome and the desired outcome, so as to provide the right direction to apply changes and make the project back on track. On the other hand, the scope management plan focuses on something bigger such as whether this project really have that potential market to sell, and how this key feature of the project will open up a new market, to avoid the overall direction to which the project is advancing towards is wrong.
In my opinion, the team member list and management part is the most important aspect of the DDP because this will lead to many negative consequences. It's very important for everybody involved to be aware of not only his/her responsibilities but the responsibilities of others as well because they have a deep understanding as to how the project is meant to go. If the responsibilities and expectations of each team member are not explicitly stated, there can be confusion among the members as to what they are allowed to do. Making this document will allow for the entire process to proceed very smoothly as it will be more organized. An important quote that illustrates this is: "If you fail to plan, then you plan to fail." As the manager or supervisor, it's very important to ensure that each team member or worker is assigned the right tasks according to his/her skills and that they are able to complete the duties. A team member should not be overwhelmed with the tasks assigned. This aspect of the DDP can be viewed as the overview to the entire process that will lead to the finished product because it states who does what. The entire process is the plan that must be followed in order to achieve the goal, which is the desired product. This is why i feel that this document or aspect of the DDP is the most important. The team members must be clear on what is expected of them so that mistakes can be minimized later on.
I personally feel like a project's quality is completely dependent on communication, especially if there is a team working together on a project. Without communication, the odds of having every aspect of the project working phenomenally as well as have them integrate with each other seamlessly is microscopic. If you were part of a team working on a new medical device, it would not matter how hard you worked on your aspect of the project if there was no communication and the other aspects did not work nearly as well or at all. It would make the device as a whole mediocre at best and all your time and effort would have been for naught. Communication is how teams determine how each aspect of the project will work with the others. It is how teams figure out the best way to solve an issue in one part or more parts of the project if they arise. If you were working on a project with a team and there was good communication, then not only will your aspect of the project turn out great, but so will the rest of it and the end result would be a fantastic medical device that was worth the time and effort put in by all parties.
Design Development Plan (DDP) contains:
*final scope statement
*scope management plan
*quality management plan
*communications management plan
*team member list/responsibilitiesCommunication management plan is the most important part of the DDP because communication management plan contains information on how to contact people and the rules to contact people involved in the project.
But I also feel that Quality of the project is equally important because it shows if the quality of the project management is going well or not ?? It allows us to keep track of how well the project is going and if it is going in the right track or not ? Whether or not it needs to be modified ?
Which phase do you think is the most important ? Please feel free to agree or disagree.
While I believe that all components of the DDP are important to medical device development, I would the scope statement to be among the most crucial to device development. Without explicitly defining the scope of a device design project, the device cannot be effectively designed and manufactured, nor can the device project be sufficiently managed.
Although all of these roles are critical to a successful DDP, the one that stands out most to me is the quality management plan. It simply determines quality policies and procedures relevant to the project for both project deliverables and project processes, defines who is responsible for what, and documents compliance. The purpose of the QMP is to describe how quality will be managed throughout the lifecycle of the project.
I believe that the team member list/responsibilities are some of the most important aspects of the DDP. Because individual responsibilties are the general make up of the whole project, they are the "wheels of the machine". If one team member duty isn't properly performed and assigned then intricate details can be left out and prevent the project from being at its peak performance.
