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djr32 replied to the topic Discussion Topic: Design and Process Verification in the forum Project Management Process and Medical Device Development 8 years, 7 months ago
Verification means to check if the inputs and outputs are equal to each other and to verify each output with a verification protocol. To an extent, it is a rigid rule that Verification takes place during the execution phase of the project. The reason is that it would become costly if verification occurred at other processes because design control processes have definite and discrete phases that are established by the “Review Meetings” at the end of each phase. So once the DID and DSD in the planning and initiating phases are set and approved in the review meetings, the executing phases start. Otherwise, if a partially made DSD is reviewed, and verification starts in parallel, there will be a lot of time wasting occurring in having multiple review meetings. Thus, it is important to establish and finalize the DID and DSD in the planning stage first and then move onto the execution phase, so a bigger picture of what is wrong with the entire project can be seen better. For instance, like in last week’s simulation, a certain verification protocol did not meet the design specification document (DSD) requirements. So, the first way to remedy this problem is to change the verification protocol. Then, if the verification protocol still does not meet the requirements, the team may have to change the DSD at last resort. This way the company is not losing so much money.
However, this does not mean that project management processes have to happen in a rigid manner. A project can have multiple parts to it that are in different phases. For instance, one part of the project is developing labels for a hydrophobic solution and the other part is designing the hydrophobic solution. The company can have the planning and executing phases occur at the same time. The label project can be in the planning stage, while the hydrophobic solution aspect of the project can be in the execution phase. Who knows, Murphy’s law can cause trouble with the hydrophobic solution that the company has to re-evaluate the planning stage for the solution.
Thus, for design control phases, it is better to have a rigid rule that verification takes place during the execution phase. For the PM process, the phases can overlap.