I think depending on the severity of the reason for recall, a number of scenarios could occur. For a situation where the risk to the consumer is small to moderate, as is with this EpiPen recall, the previous responses are the way to go: pushing an ECO and following through on the process. However, is risk is high enough and/or if consumers make…[Read more]

I’ve only been part of an “unofficial” design review meeting, but from what some of my classmates have told me it’s quite similar to what they experience. Everyone was emailed the document in review (in this case a DSD) a week prior and was expected to have at least 3 notes to bring up about the document. One person was randomly chosen to be the…[Read more]

I think the multitude of project document updates is one of the most important but often overlooked aspects of monitoring and controlling. All of these documents are going to be audited eventually so it is paramount to keep them organized and up to date to avoid future problems. If they’re not organized and kept out of date, I imagine you’ll start…[Read more]

I was working on a project during my undergraduate where I had to develop a rehabilitation glove for stroke patients. We had acquired a budget of $3000 and had to decide what we needed for a prototype. I was made the chief financial officer of our group, but I was woefully inexperienced at anything financial so our spending was very much…[Read more]

Adding on to this, here are some more quality assurance tools and techniques:

Pareto chart: This is a bar graph where length represents frequency (e.g. of complaints) or cost, and where the bars are arranged left to right in order of longest bar to shortest bar. Here the most significant matters to address are located on the left. These help when…[Read more]

For vacations specifically, it helps a lot for a PM to talk with each team member they’re managing and perhaps get a heads up on when exactly they may take a vacation. This will help you avoid conflicts in the foreseeable future. For example, if someone lets you know that they’re deciding to take a vacation during one of the most crucial parts of…[Read more]

Thinking optimistically, I think the only way a missed milestone could be a positive would be when it reveals an issue. From what I gather, sometimes project managers don’t have total control over the deadlines of a project. Sometimes it’s dictated by a consumer, a sales manager, or a higher-up that may not have the insight into how long processes…[Read more]

One of my friends had taken this course before and suggested it to me because it really helped with her knowledge of FDA regulations and when interviewers asked her about this. I had previously taken a few courses about FDA regulations but it never went into the same depth that this class goes into so I’m grateful for that. I also very much…[Read more]

There definitely will always be challenges communicating with international branches of the same company. As was previously stated, time differences, language differences, and cultural differences are all challenges to consider. However, I think the cultural differences will be the most important one to tackle. The cultural differences don’t have…[Read more]

Like many of the previous replies, a lack of communication and time has been one of the most prolific problems in the projects I’ve worked on. In one such project we had made an initial WBS that we would have updated as we gained knowledge of the processes we were working on, but as time went on we had forgotten and put it on the back-burner. This…[Read more]

I’ve experienced this during one of my internships. One half of the team was set to work doing programming for some output data from a technology no one had experience with (RFID chips), and the other half’s goal was to get that technology working. Unfortunately about halfway through the project timeline it became apparent that the RFID chips…[Read more]

I was once working on a small-scale project at Monmouth University where the project sponsor was the local fire department and my project managers in a sense were two professors. These made up the enterprise environmental factors since I don’t believe any software was used for PM.
As for the organizational process assets, considering this wasn’t…[Read more]

One the biggest problems that can arise from an overestimated budget is of course layoffs. Not only will you lose employees who have been contributing to the project, the potential demoralizing effects on the rest of your employees will make the situation even worse. Luckily I’ve never worked in a project where this ever became an issue before…[Read more]

When I was working with a 3D-printed foot orthosis project one of our side projects was testing out other possible materials to print it with. We had gotten all the way toward refining the final print design when we had learned that one of the materials we were researching was very much suitable for the requirements we had previously set. This…[Read more]

This may be a strange angle to take, but I think those “energy wristbands” that were a mild craze a while ago can be considered a general wellness product. These were ordinary bracelets that were advertised to give you more energy throughout the day. They’ve obviously been debunked in their efficacy, but for the many people that bought into it, it…[Read more]

For the mobile application, if the only function of the application was to show the heart rate I believe it still would be subject to FDA regulation. It certainly would have an easier time passing FDA hurdles than if there was more functionality to it, such as if this app allowed the user to control the voltage of the electrodes and other…[Read more]

I believe having in-person meetings would definitely have made for a more efficient use of time. When you’re part of an online class where you may not necessarily be able to meet with your group members in person, it’s imperative to set up times for everyone to meet and discuss the project. Otherwise you get a situation where people respond…[Read more]

During one of my past internships I was part of a project where we had to program a website to monitor flooding. The verification of that project was essentially whether or not the website functioned. This consisted of learning the language, programming, debugging, and repeating the process. The validation came in the form of weekly informal…[Read more]