I continuously aim to live a life not blurred by my own personal ideas and beliefs, but as humans, we all at some point default to the comfort of our own thoughts. To defeat this, we have to recognize the…   Read more»

As transitioning from academics into industry, this course is incredibly valuable in teaching what to expect. I have a far better understanding of the differences and overlap of the standards followed in Project Management processes and medical device Design Controls….   Read more»

Sponsors are the most valuable source of revenue for a small company. The business sponsor relationship is facilitated through the stakeholder management knowledge area of the project manager. Obtaining sponsorship for any business with minimal resources are almost always entirely…   Read more»

The most valuable quality to have as a PM is to know your team members. The performance of a team is most dependent on how engaged each member feels in working on the project. A PM must be able to…   Read more»

A team is only as good as a team without its most valuable member. Team members get sick. They take vacation time. Emergencies happen. There will be a time when highly valued members aren’t around to help, but if a…   Read more»

As the execution phase transitions into a project’s process, the development of a team foments. Keeping records of all team members and establishing effective communication is tremendously important when developing a team. Each team members should always have the freedom…   Read more»

It is important to note that manufacturing plays a critical role in the design control process. As development completes a project with design controls, manufacturing is managing design controls in parallel to determine how to implement the designs into production….   Read more»

It is important to note that Earned Value (EV) is dependent on the percent completion of the project and not necessarily the specific date that the cost is being evaluated. That is, when looking at Cost Variance (SV), if you…   Read more»

The PM is critical in moving a project along. It is their responsible to ensure that the whole team is on the same page and stay on schedule. As seen in this week’s mini simulation, sometimes different functional areas collide,…   Read more»

As ih37 described, it is critical to clearly establish your customer needs and expectations in your relationship with the vendor. When the packaging provided by the vendor is arriving with defects, they are not meeting their contractual agreement. Well before…   Read more»

Change to a project can have different effects on the overall project. When considering change, it must remain within the project scope. Changes cannot be made if it changes the project to the extent that it no longer meets the…   Read more»

A successful project manager lays out the communication requirements and how information is shared through the team before the start of a project. This means what details of the project must be communicated, when there must be communication, who is…   Read more»

The initial project timeline is never set. The planning process of a project breaks down the project into actionable tasks (WBS), allowing team to make rough estimates for each task, but the timeline will constantly be revisited. When a team…   Read more»

It is important to understand that the input to a phase process group is the output from the previous phase group process. That is, the inputs that are going into the execution process group requires the use of the the…   Read more»

Evaluating risk may not be as murky as it may first appear. The lectures does not go too deep into risk management, but after assessing the risks, there are methods to better quantify the risks involved. Performance measurement metrics could…   Read more»

The team structuring of risk management is dependent on the risk, resources, and time restraints on the project. As mentioned by jb678, the amount of risk involved in a project will determine the need for a separate risk management team….   Read more»

In resolving failure, the first step to take is to define the scope of what can be modified. In our simulation, this is the verification protocol and the product components. The listed specifications could not be modified. Therefore, we are…   Read more»

If I was placed in the Design Control process of a project, I would likely find preference in the putting together the Design Specification Document (DSD). This is where the meat of the engineering is. The DSD is the transitioning…   Read more»

This question becomes tricky because these documents should be carefully reviewed to ensure the safety and effectiveness of the device. We would not want minor miscalculation to snowball into a much larger issues that can become detrimental to the whole…   Read more»

From my experience working on projects, deciding on detailed specifications may seem to be the most daunting task, but becomes clear-cut the more you are familiar with the process. The most important factor when specifying ranges of specs is the…   Read more»