I think that it may be a good idea to put the extra time into thinking about the specifications of a critical component. Yes you want them to be as specific as possible, but if you know during design specification that you will need to dual source a specific component for your product, maybe it would be a good idea to do some research on what…[Read more]

This is one of those situations where you would need to find the balance between your quality management plan and your risk management plan. You need to satisfy your quality requirements first and then you need to assess the risk regarding the changes you’ve made. If you really thought about the risk involved in having a critical component and its…[Read more]

In my opinion I think in a general sense it is better to have negative SV paired with a positive CV. My reasoning goes like this, if you are on a project that is behind schedule with a negative SV but for the work you’ve completed your CV is positive I think you are in a more favorable position. You can work harder to correct your scheduling…[Read more]

No first hand experience here, but I’d have to agree with Ryan, the early stages of the project are the foundation for the future stages. Im sure small aspects can overlap or melt between two process groups, but it would be pretty impossible to move on to the next stage if the proper documents weren’t able to be completed and approved. When your…[Read more]

I don’t have any first hand experience, but I do understand and agree with why a project should be tracked this way. Your planned value will create a target to aim for by a certain date, the earned value will put a dollar amount on what work has been completed and when you take them both into account you will be able to see monetarily how ahead or…[Read more]

I have an example that was thankfully caught by internal QC before any other agency was aware. There was a situation in a diagnostic lab where a new processing technician (non-bench/wet lab position), responsible for accessioning specimen and distributing them to the proper department, was pouring off peripheral blood and bone marrow from original…[Read more]

The whole reason why medical devices, or products in general, are created are to fill a users need, and that need will be heavily researched prior to the initiation of the project, think back to the initiation stage. If you come to the validation stage of product development and your inputs are “abc” and your user needs are “xyz” (very far off)…[Read more]

I think that there are some cases where shortening the time frame of a study is a good option. Using the bone void filler syringes from the last simulation as an example, we needed to verify a two year shelf life for the product without having two years to spend on the study. Yes, running a stability study for two years would give us accurate…[Read more]

From our most recent lecture we learned that requesting seller responses and selecting vendors is part of directing and managing project execution. During this phase you are obtaining quotes from approved vendors and verifying them with quality systems depending on the components critical impact to your product. The company has done their due…[Read more]

I agree with the above statements, but in addition, missing a milestone is a bad thing no matter how you spin it. Take it as a learning experience for future improvement you may think, but in reality depending on how big the company is a missed milestone can be the difference between renewed funding and loss of contracts. Take a public biotech…[Read more]

I think the best way to avoid an inaccurate estimation is to actually have members on the team that have done similar tasks before, you wouldn’t want to take the opinion of an inexperienced person. This goes to show how each phase of project management is built off of the previous phase. Within the planning phase, team selection impacts how the…[Read more]

jr377 taking into account how long the built in buffer should be is an important point to bring up. As with all parts of the project this too will be a factor that impacts the budget. The extra time allotted for a buffer window must be factored into the overall project budget because that is more time the company needs to pay employees or…[Read more]

In my opinion a good way to avoid scope creep is to have a highly efficient planing stage prior to the submission of a final scope statement. Make the most out of each meeting and get all ideas on the table, try to think ahead about what is a feasible outcome for your product and really try to hone in on the aspects that are to be focused on and…[Read more]

Honestly I don’t think there is a grey area on when to shut down or continue a project with an assessed risk. I think that when a risk analysis is done and the results are shown to the company/stakeholders/sponsors, they will be the deciding factor on whether the project will be a go or a no-go, if the risk:reward is positive or not. I don’t think…[Read more]

I think that the best way to prevent employees from going off on their own and making decisions that will effect the whole project, is to have a clear scope baseline. As a project manager you should have your scope statement, a clear work breakdown structure, and a work breakdown structure dictionary. Having a clear scope statement will outline…[Read more]

“High Complexity Tests

This category includes those tests that are modified by the laboratory, developed by a laboratory, or a test classified as high complexity under CLIA. Laboratories under CLIA and COLA also must comply with Section §493.1201 (general QC): The laboratory must establish and follow written QC procedures for monitoring and…[Read more]

In an ideal world a company would fully fund projects large and small, but I think priority will ultimately come down to a risk reward analysis, how much money a company is willing to put into a project versus how much money they expect to make off the project in the long run. In the original post I would assume that the hip and knee department…[Read more]

In addition to giving ample time for members of the project team to review documents before their approval, I think that it would be beneficial to have frequent short meetings in between official design review document approval meetings. I think that this can be an efficient way to ensure that all members of the project team are continuously on…[Read more]

I haven’t had the opportunity to work in industry yet, but if I could choose one of the nine parts of design controls to focus on I would choose design validation. Having a product that is ready for a clinical trial or to be tested out on a cadaver seems very rewarding, especially if everything goes right, and even when things go wrong there is…[Read more]