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. Determine the causal relationships
3. Identify effective solutions
4. Implement and track sol…[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 specify the actual project plan but rather specific tasks which are associated with working on the project. We know the critical p…[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 throughout the duration of the project because many factors are to be accounted and to know all factors is impossible since the wor…[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 the second project because the cost variance is positive, a positive value means yours under b…[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 should be part of the planning phase if they aren’t already. The reason I state this is what happens if m…[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) . A company should have this in their collection of documents. This helps to eliminate errors which have been made in the past. The…[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 monitoring and control phase as we have learned this week. You may need to order more parts or had…[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 way out of the scope they originally intended in their project charter. You Amazon being a middleman distributor, to…[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, the medical device can go to any one of these routes. However, if the device goes to the wrong…[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 ks629 stated in my opinion 100 and whatever test one is doing comes back 100% positive for a…[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 at the overall timeline of the project. For tasks that do not need to be done immediately or on the critical path we, can use the…[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 important to get the perspective from them and to be implemented into the designing of the device. Like Devarshi…[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 move on with next task. As stated it can be a Start-Start, Start-Finish, Finish- Start, Finish-Finish tasks that are categorized for…[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 problem did arise they may not be ready for a failure that takes place suddenly. Risk management can be planned ahead time bef…[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 project or a phase and documenting initial requirements that satisfy the…[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 status meetings with Dr.Schesser. He is monitoring the overall issues that we can have with the project…[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 device development. You need to have a clear and concise plan set in place of how communication…[Read more]