In addition to the control measures mentioned in the previous replies, there are other ways to control scope creep. One essential way is to maintain open and transparent communication with everyone involved in the project, especially the stakeholders. Doing so…   Read more»

There are multiple factors as to why smaller companies do not have Quality Management (QM). One of the reasons is because of resource constraints. Smaller companies typically have limited personnel and financial resources and implementing a Quality Management System (QMS)…   Read more»

Both bottom-up estimations and analogous estimations have their benefits and limitations.  For more complex projects, a bottom-up estimation may be more effective where the tasks are well-defined and the project scope is clear. Moreover, projects with higher stakes often have…   Read more»

It can be tricky to ascertain when a gag order is needed. For example, a gag order should not be issued when reporting illegal activities or when there is a violation of ethical standards. Therefore, it is important to maintain…   Read more»

Ensuring that academia’s open research culture is aligned with the industry’s need for secured data can be difficult but possible. First, clear communication and expectations should be outlined where data sharing, storage, and protection should be discussed. Data sharing agreements…   Read more»

Although schedule, budget, resources, performance, and scope are some parameters that should be closely monitored and controlled, there are a few other parameters that should be controlled as well. One of them being quality assurance. It is essential to control…   Read more»

The project manager/team may still be involved with the product even if the project is closed and is being transitioned into production. This is because they may provide valuable expertise or knowledge regarding the product and serve as SMEs. The…   Read more»

One way to navigate through negative SV is to identify the root cause behind the delay in the project schedule. Reasons could include resource constraints or changes in requirements that delay the schedule. Reallocating resources could also aid in navigating…   Read more»

When working with medical devices, the safety and efficacy of the products must be maintained, especially through change controls. It is typically the change control board/committee that oversees these changes. The board/committee contains individuals who are equipped with the necessary…   Read more»

Balancing internal and external expectations requires a combination of communication, collaboration, and having a clear framework for decision-making. This can be achieved by ensuring that the changes in the project align with the strategic objectives of both companies and ensuring…   Read more»

As mentioned in the responses above, there are multiple ways to navigate dynamics between multiple project managers. Establishing clear goals and responsibilities for each manager would diminish any confusion between them; moreover, tasks can be allocated depending on specific project…   Read more»

Companies need to manage risks while also balancing innovation and patient safety. Some ways to do that can be through iterative design and verification processes where the project would have incremental improvements while also ensuring that each iteration is up…   Read more»

As mentioned in previous replies, organizational process assets (OPAs) are the primary source for procedures and guidelines that exist within a company. OPAs contain documented procedures and guidelines that provide a framework for how the work is performed in the…   Read more»

The pre-feasibility/feasibility dataset and the BAM dataset are interrelated in many ways. One way is that the data gathered in the pre-feasibility/feasibility dataset provides information regarding the technical and financial aspects of the project which sets up the premise for…   Read more»

Using and developing a detailed Gantt chart can be time-consuming. Even more so when the dependency is solely on the project manager. To mitigate this issue, the project manager should hold collaborative planning sessions where team members from different areas…   Read more»

Mitigating financial challenges requires a multifaceted approach where the focus is not only on the business case presentation but also on developing strategic and innovative financial planning. Some ways to mitigate the obstacles mentioned can be through the use of…   Read more»

Keeping project finances from PMs does seem counterintuitive; however, there are some reasons why it may be beneficial. One of the reasons could be that organizations want to encourage creativity and innovation and limiting knowledge of the budget could force…   Read more»

The key distinction between FS and SF is the direction of dependency. FS can be described as having a “forward-looking” dependency where Task B’s start is dependent on Task A’s finish. SF can be described as an almost “backward-looking” dependency…   Read more»

There are different avenues that new companies could approach to develop these estimates. One of them is to consult experts within the industry, for example, subject matter experts (SMEs), who can provide valuable insight regarding the estimates. Moreover, these new…   Read more»

There are various traps and obstacles that can occur during the project initiation phase. One of them could be the possibility of having unclear project objectives which would result in delays and even project failure. This can be mitigated by…   Read more»