Once of the most important things that I will take away from this course is the value of good planning. In industry, I have been part of project teams with poor planning and with good planning. On the projects with poor planning, deadlines were missed, communication was not good, and people were not working well together because they were blaming…[Read more]

Preparing a schedule for a clinical trial is done using the same tools that were used for others projects: by creating a WBS and a Gant Chart. The WBS should include pre-study tasks, study tasks, and post-study tasks layed out for the entire project. The pre-study tasks include a request for clinical evaluation, creating a clinical development…[Read more]

I think that it is a combination of the culture in America as well as the individual’s inner motives. America’s businesses are valued at how successful they are, and 50-60 hour work weeks stem from the idea that working longer means that more work will be done and the company will make better numbers. For motivated individuals, this is true. It is…[Read more]

Retaining good talent is important, especially within medical device companies where historical knowledge of the product is very valuable. As stated in the posts above, the key to retaining good employees lies in keeping them motivated. On a scale of a few months to a few years, making sure the employee’s good ideas are heard and buying them lunch…[Read more]

An excellent point that ks629 brought up is that historical knowledge of the products at a medical device company is invaluable to the company. If a company has a culture where engineers are hired only for the duration of a project and then are let go, the company is losing a valuable resource for knowledge of the device. Although the medical…[Read more]

While it may be beneficial to have a broad communication management plan defined in an SOP, I think that communication management plans tailored to individual projects are more beneficial. This allows for the Project Manager to lay out exactly how the team members will receive the information that they need and how the details of the project will…[Read more]

One of the most important things to have included in a vendor contract is the condition that they need to notify your company about any changes that they have made or are going to make to the components that they supply to your company. These changes can range from a change to the overall design, a change in tolerance, a change in material, and a…[Read more]

Changes can be made to design control documents, SOPs, DMR, BOM, DID, DDP, DSD, verification/validation protocols, and the risk management plane. Changes will go through a design review process during which documents are reviewed, changes are made if necessary, and documents are approved. Once the document is approved, a controlled copy is updated…[Read more]

An additional factor that I would add onto the list that Aasutosh suggested is performance. While resources (people) may be available, if the work is not satisfactory then things will need to be redone. By monitoring performance in addition to costs, schedule, resources, etc. you can ensure that whatever estimates you do make about the timeline…[Read more]

One thing to consider when handing over a product from development to production is to think about the person that will be assembling the device. During development, the product is generally being assembled by the engineers that are coming up with the design. As a result, the SOP which provides the instruction for the assembly may contain a lot of…[Read more]

In the last project that I worked on, a major source of delay for the project came from lack of project resources. Resources which were needed in the second half of the project were promised to the team at the beginning of the project, however when the time came the resource was no longer available. The project progress was significantly slowed…[Read more]

As stated in earlier posts, Planned Value is the expected value (or amount completed) for the project on a certain date, and the Actual Cost is what the project actually ends up costing. These two values matter in the Monitoring & Controlling phase because the are used to calculate Schedule Variance and Cost Variance. The relationships are as…[Read more]

In my project team, we have a tab on our project dashboard with the vacation schedules and proxies of every single member of the team. This allows everyone to be aware of any planned vacations ahead of time, and who is taking over the responsibilities of the absent member while they are away. We have found this to be an effective way to keep the…[Read more]

Successful project execution relies upon completion of the activities in the WBS, following the guidelines in the DDP, and completing tasks and work packages. In the role of Project Manager, it would be important to emphasize that all project team members are up to date on information and that the project tasks stay within scope, so that the…[Read more]

As cs22 had mentioned, the response to a failure depends on the severity of the problem. Throughout the project it is important to meet the requirements that were laid out in the beginning. If failures occur with experiments and with vendors, the reasons why the results were not as expected need to be determined. If a resolution with the vendor…[Read more]

I agree with f-dot and msc52 about the suggestion of adding an “Updates” step to the steps of project scheduling. This allows for the project manager to be aware of any potential delays to the original timeline, and will allow him or her to be able to communicate to the other members of the project team who may be affected by it. I came across…[Read more]

Another thing that might be included in a verification report is sample traceability. In the reports used at my company, there is a place to fill out part numbers, lot numbers, and production date of the samples that are used in the test. This allows for better traceability if there is a failure, and other defective parts will be able to be…[Read more]

The risk of not meeting the planned dates, particularly the Late Finish (LF) date, can be mitigated by including some buffer time, as smk45 suggested. During the project planning phase, you want to make sure you account for and mitigate any possible that may arise throughout the project. However, as anyone who has worked on a project team before…[Read more]

I was working on a project to requalify all of the components that were used for a cardiopulmonary device, and one of the tasks that was overlooked in the planning phase were all of the packaging that was used. Simple things like protective cardboard that the wrapped, sterile devices were shipped in became a big task to qualify due to the number…[Read more]