While having a common communication management plan will save time, I believe it needs to be altered depending on the project. If the plan doesn't help all participants clarify and voice their opinion...

The WBS is a crucial part of the scope management process, no matter how small the project may be. It is responsible for breaking down all the tasks, delegating work to each team member, and making su...

Specifications should be broader during the beginning of design control, but should narrow down during the later stages. The project team can also refer to previous similar projects and compare previo...

I believe it depends on how negative the SV is, and how close the team is to completing the project. If a negative SV was calculated closer to the beginning of the project, there is still enough time ...

The project manager should discuss the amount of work and timeframe required for the project with potential members to make sure they can fully commit to the project. That timeframe should include vac...

One main solution to staying on or ahead of schedule (positive schedule variance) is adequate and thorough planning during the initiating and planning phases. During weekly design review meetings, the...

I believe that one of the most important aspects of the monitoring and controlling phase is the design review meeting. Any additional changes, metrics, variances, and updates can be discussed in these...

While I do not have any industry experience in design review meetings, I think it is crucial to finish the previous step before moving on to the next. Even if you are on a strict timeline, it is irrat...

The FDA is strict on ensuring all guidelines are met when audits are conducted. Works logs are one of the documents auditors must review and reference during their visit. If work logs aren't properly ...

Since we are already at the validation phase, I would try to fix the issue with the primary vendor first. I would consult with the primary vendor about the amount of defeats in the packaging provided....

I would also follow the ISO requirements and guidelines regardless of enforcement. I feel that developing a medical device that causes users harm during testing and execution defeats the purpose of de...

Design validation is crucial, especially if verification fails during the executing phase. It is important to confirm that each numbered input meets the user's needs, before it is tested in a clinical...

Delays are bound to happen, but steps can be taken ahead of time to minimize the magnitude of them. In Dr. Simon's lecture, he mentioned building a shed as an example. The planning phase is crucial to...

With a deadline fast approaching, it is important to set a strict deadline for the team to follow. As project manager, I would makes sure to designate roles to different members of the group and sched...

Project managers hold an important role in encouraging group communication, overseeing any disputes, and setting a feasible timeline for each project. The manager needs to be able to clearly state his...