When I think of retention I think of elementary school days as to when students were retained because their grades were not adequate to advance the next grade or class. This is the negative connotation of the word. The positive…   Read more»

Root cause analysis (RCA) is a method of problem solving used for identifying the root causes of faults or problems. RCA has ‘general’ principals associated with it throughout many articles. 1. Define and describe properly the event or problem 2….   Read more»

For my Senior Design Project, we have to set-up a WBS. We use Microsoft Project Planner to monitor the tasks we have as well to see the critical path i.e(longest path for work to be done). However, this WBS doesn’t…   Read more»

I agree with amin-sadig in terms of people misconstruing the data, it unethical obviously. We live in a corrupted world and people will do anything to get ahead or to look “good”. I agree that cost may not be uniform…   Read more»

The way this question is stated isn’t clear and concise. The reason being is we have no information i.e(as mentioned before) about the project(s). We do not have an substantial information to qualitatively answer this question. However, I would take…   Read more»

I have no experience with this however, I can provide some insight. For the process of design transfer to be easier I believe status meetings should be done prior to the project being handed off to manufacturing or production. Manufacturing…   Read more»

As mentioned above most have spoken on factors which have a negative outcome on the SV. However, there are positive factors which lead to a positive SV. One of those factors is to use the DHF (Design History File) ….   Read more»

I disagree with the above statement because the planning phase of PM is devoted to acquiring the necessary components for the project. During executing phase, the project is immediately being worked on. However, there may be an adjustment in the…   Read more»

I have never worked for a medical device development company however, this topic is intuitive. This can be applied to any company and not just medical devices. Google and Amazon have become companies that I am sure to have gone…   Read more»

When it comes to a PMOA there are three regulatory sectors that can be exploited: Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation (CBER) and Center for Devices and Radiological Health (CDRH). With these centers or sectors,…   Read more»

I agree with hc255. I do not have any experience with validation and verification processes. We know validation is the final step after verification correct? Deviations from the DSD after validation should be prohibited. However, say a sample size like…   Read more»

The easy answer to the question is to be prepared. With being prepared that means speaking to the various process groups and working on Work Block Schedule or a gnat chart. With the gnatt chart in place, we can look…   Read more»

With the planning phase the communication management group as well as the project manager share in the same phase. The project manager has to reach out to the various stakeholders that will actually be using this medical device. It is…   Read more»

Gnatt chart are used in capstone for the development of a potential medical device. We have certain tasks that are place on the critical path which must be done in order complete either the project as a whole or to…   Read more»

As DR. Simon stated the old proverb “ if you fail to plan, plan to fail”. This means including risk management helps for a company not to fail suddenly. If a company never considered risk management then when an actual…   Read more»

The scope is the process of developing a detailed description of the project and product. The inputs are projected charter, requirements documentation, and organizational process assists. The project charter is the process of developing a document that formally authorizes a…   Read more»

With M&C there is the process of tracking, reviewing, and regulating the progress to meet the performance objectives defined in the project management plan. Capstone is a great way to learn what project management is like. For example, we have…   Read more»

I agree with you ks629. The Project Management Process Groups are all valid processes for the different management groups. What is important as Dr. Simon said is the Project Communications Management Group. This group is an integral part of medical…   Read more»

I do not work in an industry, however, I currently am taking Capstone which I consider the class to be a Matrix set-up. The reason for this, is I report to both the functional manager i.e.( Dr.Schesser) and the project…   Read more»

From reading all the response I did some research and found that there are 6 categories involved with Risk Management. They are Risk Identification, Risk Responsibilities, Risk Assessment, Risk Response, Risk Mitigation and Risk Contingency Planning. A Risk Management Plan…   Read more»