I agree that communication is the primary tool that you should use to handle these types of issues. To keep people on schedule you may have to have regular check ins on project progress so that you ca...

In addition to all the earlier points, in a regulated industry such medical devices rigorous documentation is required at many of the project stages. Falsifying progress would mean lying on official d...

I pretty much agree with the majority opinion here on project monitoring. I also think the biweekly meeting is great idea that suits the majority of the monitoring needs without being overbearing. For...

I agree with your point that withholding project financial information from a PM seems extremely detrimental. Reading this thread I did see some seemingly reasonable answers as to why this practice wo...

I agree with many of the posts in this thread about creating buffer in the schedule being one of the most effective and definitely one of the simplest ways to reduce the risk to the task being late. J...

One solution to the information problem is to have short (about 15 minute) daily huddles to provide critical updates. This when paired with some project dashboard software that allows for tracking of...

A key way to reduce slack days used when considering team members schedules it to maximize redundancy within the team such that people can always be shuffled in the event of team members being out, or...

I think everyone has brough up great points so far in this discussion on how to measure relevant and useful metrics. One key point that I think no one has brough up yet is how you need to ensure that ...

While it might be technically possible to recover from being behind schedule and over budget, I think that recovering from both of those conditions is incredibly unlikely. As someone else had said, be...

As an employee I prefer most important or simple communications to occur through teams. However, teams itself is not really built for a high volume of communication unless it is direct conversation, e...

While changing multiple steps in the verification process does seem more efficient a key aspect of regulated industries in general is finding the root cause of issues. Executing multiple changes to th...

Hypothetically, if I could change the DSD I would alter the part of the DSD that required that the label pass a submersion test. In the instructions for the simulation the simulation mentioned two pro...

As said a change control process is essential in managing design changes in a project. A change control system will allow for a thorough analysis of a design change and its potential impacts. This is ...

When considering risks for in medical device project management, technical and regulatory risks usually also have financial implications to them. An issue with a regulatory filing, will almost definit...

I think that while Design reviews and Design change requests are important to do during the check and act phases, I think it is just as important to do these during the "Do" phase. While doing a final...