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 stricter protocols since it seems too relaxed. The…   Read more»

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 instead taking precaution in project development. Yes,…   Read more»

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 action to correct unforeseen problems. Address…   Read more»

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 in clinical trials that pose the most risk. The risk at…   Read more»

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 incorporate the RACI (Responsible, Accountable,…   Read more»

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 a violation correctly increases the chances…   Read more»

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 project may fail and assess the severity…   Read more»

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 most importance and it is one…   Read more»

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, integrating the risk management team with their…   Read more»

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 the most are the customers/patients that use these products. Errors…   Read more»

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 number (RPN). This is an easy way…   Read more»

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. Therefore, I think it…   Read more»

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, making frequent measurements can help monitor performance in these areas of…   Read more»

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…   Read more»

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 on these potential changes helps expedite the process during project development. It would prove…   Read more»

I think a great approach to fix the potential problems from each extreme side is to incorporate two ways of communicating informational updates. For information that does not require questions and in depth talks, it can just be put into…   Read more»

I think project managers can strike the right balance between providing enough information without overwhelming stakeholders through two methods. The first method would summarizing the updates effectively. Sometimes the parties involved in the project do not need every exact detail…   Read more»

I think the biggest challenges in achieving scope verification are managing the communications between all team members and stakeholders in the project. Scope creep is the result of missing or lack of communication between people involved in the project. A…   Read more»

Using an agile and stage gate hybrid approach would require checkpoints throughout the project timeline. This keeps all the personnel in the project in line with the project goals. Also, the team can pivot quickly to fix an issue with…   Read more»

A major strategy to ensure that all stakeholders stay aligned is by everyone acknowledging who is responsible for certain tasks in a project. Tools can be used in parallel like a Gantt chart and a RACI (Responsible, Accountable, Consulted, Informed)…   Read more»