The change request log has definite importance, but the change request meeting is probably more significant. Often it is very difficult to articulate a change request in text form – unless it is something simple – but anything requiring a project management lifecycle is probably not simple. There must be opportunity for a one-on-one meeting with the design control specialist.
For software coding projects this is the case. You can write a change request that reads like your best written work, but that is no guarantee it will receive proper interpretation. You need to interact directly with the software coders. They often make decisions based on ease of implementation. If they believe your change request will require significant time, they may assign it a low priority, but if they believe it is a quick fix, you can get it done quickly. Hence the value to secure a meeting time.
I believe that verification is extremely important to design control in medical devices. As user needs are identified, designs for satisfying those needs can begin. It through the verification process that that quality, safety, and effectiveness can be maximized. Without the monitoring and conrol technique of verification, then optimizing product development can't be achieved. That is supported by setting specific milestones, systems of final sign-off, and an efficient quality control unit can all support verification and other monitoring and control processes.
Any project needs a Monitoring and Controlling Process to assess success and make adjustments in order to avoid potential delays and improve workflow. It also includes a range of expertise and experience for making the decisions necessary to keep the project active. Communication management is, in my opinion, the most important method for ensuring effective project oversight and control. If the project progresses into new stages, it becomes important to communicate the new tasks in order to allow appropriate improvements in previously completed activities that will need to be evolved or omitted as the project's emphasis shifts.
I think Verify Scope and Control Scope, Control Schedule and Control Cost, Perform Quality Control, Report Performance, Control Risk, Administer Procurement are the basic components of a project control system. To use them:
1.Verify scope generally comes after perform quality control. When your project deliverable is accepted from quality control, it will move to verify scope stage, Your customer will verify the scope whether the deliverable fulfills the entire requirement and if it is correct at that point, the deliverable will be transitioned to the customer site.
2.Through Earned value management (EVM), you should control the schedule and cost for your project.
3.Before delivering the product to the customer, you need to cross-check whether you are delivering the product with the quality required by the customer.
4.Risk can be anytime and anywhere in your project. As a project manager, you can not say that you will check risk only in the monitoring and controlling stage.
5.If you are subcontracting any process to some other party, you need to monitor their performance also in a well-timed manner. Based on their performance, project fate could be decided. So, don’t take it lightly. It is the project manager’s sole responsibility to monitor and control the work of subcontractors too.
Although every technique in the monitoring and controlling phase is important, I believe that the approval or rejection change makes or breaks the project. Suppose a PM approves of a medical device that still has potential hazards that were possibly overlooked during evaluation? Suppose a PM rejects a drug due to not meeting "their" expected results yet the results that were provided could project skyrocketing sales? These decisions are also important when it comes to finances. Approving too much money from a stakeholder that may lack success will put a project in a ton of debt while on the other hand, rejecting a great offer may put a project on hold due to lack on money.
