I totally agree that Failure Mode and Effects Analysis (FMEA) should have been incorporated. This seems like an immense oversight in product development. I think the project and the project team need ...

I think management needs to realize the importance of risk management and enacting contingency plans. Whatever can go wrong will go wrong. This is not to have a negative view on everything, but instea...

To start, I think a project manager should reinforce and emphasis the original scope. Depending how long the project is, maybe some personnel forgot the details of the true scope. This is the first ac...

I think incorporating Risk-Based Monitoring could be an effective way to maintain study qualities without sacrificing cost and timeline goals. The analytical data that RBM provides can identify points...

I have not come across a project where there was a lack of structured communication, but I think I have some thoughts on effective tools and strategies to remedy this. My first thought is to incorpora...

I think keeping clear definitions of a deviation and a violation to all staff are necessary. Trained staff is better than untrained staff. Untrained staff that may not be able to classify something as...

I think using Failure Mode and Effects Analysis (FMEA) can be an effective approach to prevent errors, losses, or subsequent issues. It is a tool risk management would utilize to identify how the proj...

I think it is very important to bring up these past situations so the future generations can continue to learn to avoid such disasters. In medical device development, safety to the patients are of mos...

I definitely agree with the last post that using a hybrid method using both analogous and bottom-up estimation methods is an effective approach. I think to confront the uncertainty aspect in a project...

I think that cases like these really highlight how project development errors can affect stakeholders so strongly. Many parties will suffer because of something like this. The stakeholders that suffer...

As the last post mentions, FMEA is a great and effective decision-making framework to use in such a scenario. It is extremely effective because it presents data to help calculate a risk priority numbe...

I think the aspect of sharing unfinished designs can be improved. Even though sharing a successful idea can boost the morale of the team, it can be just as devastating if one small thing goes wrong. T...

I think a way project teams ensure that they measure relevant metrics is to focus on measurements pertaining to regulatory demands, validation and verification milestones, and risk management. Also, m...

Using the information about EV, PV, and AC, I think could pose a risk if it is not paired with any other form of analysis. EV, PV, and AC are surface level ways of telling you that the project is suff...

Organizations can strike the right balance between maintaining control and allowing flexibility for creative problem-solving and adaptation by incorporating quick responses from the CCBs. Agile review...