I agree with the comments above, it is difficult to point at which role would be the most critical for a project manager. If I were to take a guess, I assume that creating the story behind the product line. As Andrew mentioned earlier, their are great and innovative products out there but don’t have a story. In addition, from my experience, the…[Read more]

I have heard from fellow coworkers of projects being “killed” because of a shift within the market or money is shifted to another project due to unforseen circumstances. In this instance, the project is not fully killed but just put on hold until all issues are resolved.

Chris

I personally never had experience dealing with recalls, but I assume that are some costly side effects from a recalls such as tainting of the company brand to potential litigation if the recall is based on causing harm to individuals. I think all possible “Risks” should be considered before releasing products. Especially if the products can come…[Read more]

From my experience the quality assurance team performs tests on everything that comes in for product to ensure that the material meets it’s specifications. They also test materials from vendors, and ensure that the vendor material meet our specifications. From my experience the Quality assurance team’s approval on the DHR is needed before…[Read more]

As a PM, these types of scenarios should be anticipated with proper communication between all team members. As a result the project manager as the responsibility to organize and communicate between team members, it is important to have weekly updates on project statuses to address potential complications that may delay project deadlines.

Chris

Ussually when looking at vendors the company has a list of approved suppliers that would ease the purchasing aspect because prior business has already been initiated,and buying from an approved supplier means that you know what type of quality of product you will be receiving. So essentially you may not need to qualify the vendors if they are…[Read more]

Hi Fady,

when we say severe failure, are there critical components within the equipment that broke down or is the product itself being produced or being check incorrectly? I would say that we should treat this as a preventative maintenance to restore the equipment to a satisfactory operating condition and we could run a verification to ensure…[Read more]

Well it depends, setbacks and delays often occur, but my question is, since this component is critical, does Arugalo Medical have a list of approved suppliers for this component and is this company the only supplier? Lastly, wouldn’t it be reasonable that Arugalo Medical may have a surpluss of supplies in case of situations like this arise.

Chris

That a good question and it could be slightly trivial to answer. I believe that the original validation would not expire, but lets says there is a gap between the validation such as let’s say that you just did an installation qualification and process qualification on a new equipment, 30 yrs later you look at the validation of the equipment and…[Read more]

I don’t think missing a major milestone can particular effect future success of a product/project, delays should be anticipated and addressed in a timely fashion. Usually project managers incorporate potential delays/setbacks within their timelines, because they do happen. Now is the setback is on something major that could’ve been prevented or…[Read more]

I agree the comments above, with the support of Dr. Simon’s courses I feel that his courses provide a real world approach and look within industry. There have been countless of times were I refer back to my lecture notes to fully understand why a particular approach was initiated within my job and my lecture slides provided me answers to those…[Read more]

I agree with the comments above, I believe that the biggest difference would be dealing with the diverse regulations. From my previous experience within a cosmetic standpoint, I was working on a reform on an overseas product, both the overseas product and the American product had the same ingredients, but the big difference is that the European…[Read more]

I had a similar experience, but with the purchase of a 2 identical pieces of equipment, but they were being placed at two different locations. We had to validate each piece of equipment, but with regards to our Test method validation, we only had to do that on equipment due to the fact that they were identical. But with respect to this particular…[Read more]

Hi Viraj,

it really depends on the equipment or the process you are trying to validate. There are some, for instance if you purchase equipment from a vendor, there are cases were you can validate this equipment as an COTS ( Commercially Off the Shelf) often times a validation package may be purchased and you may just have to bridge the gaps of…[Read more]

Interesting topic, but is the balloon popping an isolated incident or does it happen all the time? I do agree that more time will be needed by R&D to address this issue, but is this product already in the market? if so manufacturing engineering will also have to address this issue as well. There could be a mishap in materials or in production that…[Read more]

For my senior design project, we were working on a non-invasive vascular stiffness monitor, we were prototyping on bread board, which connected to a an ossciliscope for data analysis. Half way through our project we realized that the breadboard had areas with corrosion, thus effecting our connected sensors and our results. Based on our timeline,…[Read more]

I have had a a few experiences in which completion of projects have been delayed, I was validated a new piece of lab equipment, during the validation process i ran into delays ranging from the acquisition of testing equipment to approvals from R&D with regards to process. My project manager knew the potential in delays because this new equipment…[Read more]

I would say that it depends on the severity of the change, if its a major change that all documents should be adjusted and perhaps another safety assessment may be needed if it changes the function of the device. If lets says there is a new supplier/vendor being introduced than an ECO would be needed to address the change and slight modifications…[Read more]

The essential differences are is that DMR contains all documentation for the design and manufacturing of the current product and all process are fully documented, while DHR contains all production/process records of the device.

Chris