I also have had an issue in the past with my senior project when it came to the Critical Path. During my senior project a lot of the group members thought we knew how to run simulations and so we accounted for it only taking up maybe three days at most. However, when we finally came to this step, we didn't realize how complex the geometry of project was, and so this definitely took more than the time we accounted for. This involved getting help from our professor, learning the software more extensively and making sure we're using the right boundary conditions and constraints. Basically, what I learned is that getting your teammates to actually learn the software or basis of a procedure could actually contribute to a lot more time than expected and can actually be considered a step on the critical path.
While working at General Dynamics Electric Boat, I worked on nuclear/radiological related projects (my undergraduate degree is in nuclear engineering). Engineers on the non-nuclear side were sometimes put on nuclear jobs and they would ask me to assist them. They always thought certain nuclear regulations didn't apply to their "small" job that happened to be in a nuclear boundary. They assumed anything related to nuclear regulations would be an extraneous task or if they had to be completed at all, wouldn't take long. They never scheduled enough (sometimes any) time to go through all the steps in the review process with the many different people and the project would end up on the critical path. Many of these engineers had strict schedules to adhere to so helping them stay on schedule was a challenge. I usually ended up running around the shipyard on weekends (sometimes, in the middle of a blizzard), calling in favors, and still not meeting the deadline.
In my time as a research assistant at a drug discovery & development laboratory, I ran into a particular issue that I believe had the potential to affect the critical path of the project I was working on. The drug I was charged with synthesizing had two parts: a ‘backbone’ (which was a standard base molecule that different substituent groups were added onto) and the specific substituent group. After each synthesis step in the building of the target molecule, there were purification procedures that were thought to be trivial. However, after on particular synthesis reaction, the byproducts and the target drug compound were so similar in weight and polarization that separating them became a real challenge. Very quickly, this previously thought trivial step turned into a few day ordeal; quickly putting it on the critical path. Lucky, there was enough slack time built into the method to account for such an issue to not affect the targeted final drug testing date.
In industry there are many times where an extraneous task suddenly turns into the critical path for a project. I had experienced this while working at Stryker on surgical cut guides that were 3D printed out of grade 5 Titanium. It was not observed until after the design freeze during a cadaver lab that the cut guides created a lot of debris while in use with the designated saw blades. The material selection and manufacturing process of the guide were originally simple and completed tasks, that ended up delaying the whole project because it now was leading the critical path.
I volunteered in a tissue engineering lab and we were working on trying to make a bio-ink with a decellularized pig heart.
We had researched previous inks and composition models and did what we had to do. At the end of it all, we were ready to put it through the printer and then we had realized that the printer heats up during the printing process for prolonged exposure and practically ruined our composition. We had spent the entire summer on the project and were so close to finishing but yet it was that simple factor we didn't consider that put us back a full 4 months
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 of vendors that were used worldwide. Further delays were caused by the unavailability of packaging engineers. As a result, the task was added to the critical path and completion of the project was delayed.
For the current project that I work on it with my company, The biggest concern is about part allocation. Flash ICs are one of the major components to build SSD and DRAM after the microcontrollers. It happens couple time that I would be able to spec in and qualify a project, But due to the lead time for the Flash ICs is longer than customer request. we have to meet the customer expectation of certain data. The company has enough stock for the major product line, however, it is more problematic for specific or customized solution, which delays the whole project up to 16 weeks sometimes.
At the company I work for, one of the tasks I had to complete was to finish building a lateral compression tester used in our lab to test the firmness of breast implants. This second fixture was to be shipped to our R&D team based in California so that they could also run the same tests as us instead of shipping implants to us solely to get test data for. The staff engineer on our team made this device from scratch several years ago from which the second testing fixture was modeled off a few months ago. Once the fixture was built and wired exactly, all I had to do was perform V&V testing to ensure that the testing fixture was communicating to the custom made LabView program. The labview program read force values in lbf units from a force gauge sensor, which was connected to a load cell on the testing fixture. I assumed since everything was built to be exactly like the original testing fixture and that the wiring followed the wiring diagram to the dot that there would be no issues. Of course when one assumes this, usually circumstances will prove them wrong. The fixture wasn't communicating to the computer and it took me some time to figure out that I just had to reassign COM ports to the USB connections so that LabView can read them and also that I had to change the force gauge sensor settings to communicate via RS232 instead of USB. It was a simple fix but making sure all the settings matched up to the original testing fixture from the beginning would have saved me a lot of time in the long term because the fixture was delayed from being shipped out by 2 weeks!
Within my company there was a project I worked on where we looked to have a new titanium bone screw system used with foot for bunionectomies, fractures and osteotomies released. The system was acquired through a product acquisition. There were lots of eyes on these components of the project however one aspect that seemed rather irrelevant was an update to the packaging of this system. There was to be an additional bubble bag introduced within the system that would not however come into contact with the implants. Now to just introduce this bubble bag into the packaging of this device there were numerous steps that needed to be followed. The main task was on-boarding the suppliers and approving them from use. This took lots of time and documentation to do which took more time than expected.There were updates to the work instruction that needed to be incorporated as well and adjusting the supply chain. This unfortunately the disadvantage with larger companies that even something as simple as this led to lots qualification and documentation that normally would be overlooked by upper management.
I have experienced this situation several times in projects, and I believe that often it is due to a lack of understanding of these seemingly simple parts of the project that may take much more time than is budgeted for. From my experience, this often happens with processes related to our Tier 2 suppliers. For example, our suppliers may outsource certain processing steps, such as metal coating, or may purchase parts for our products from a tier 2 supplier. Sometimes the project manager "thinks" they have a good estimate of the time it will take for these outsourced processes or procured components based on past experience and never follow up with our supplier to double check. Later down the road, when it comes time to execute the processing step at the outsourced vendor or procure a part from an outsourced vendor, they find out that the lead time was 4X what they were expecting. Immediately this processing step then becomes the critical path. The lesson to be learned from this is never to assume a lead time for any process, no matter how simple it seems.
On one of the project that I was a part of, there came about an issue with air dams not being compatible with our new server racks. Air dams are used to restrict air flow from underneath the rack and we had made a “universal” one that was to be compactible on all of our products. Our customers made it clear that all racks shipped to them had to have these packaged with them. On the newest server rack we were designing, the mounting hole pattern changed slightly because of some feedback we got from our customer. This caused the air dams to not be able to fit up on the new rack. No one thought of how this would affect the air dams since everyone always just assumed that we had a design for them in place. Well the day finally came where it was discovered that the “universal” design didn’t work, which caused delays in shipping the product, because now we had to make new ones and also had to wait for our vendors to manufacture them with their lead times. My company got so used to having them ready that we got careless when a situation came about like this, where we got a wakeup call to always double check if all existing accessories are compatible with new products.
During my capstone project unfortunately we had many critical path situations. Our project was a monitoring device, using a blood oxygen sensor, and accelerometer that can transfer data to a secure UI. Our goal was to make this monitoring device compatible and with one another. The issue was the sensors were not able to transmit data to our UI that NJIT offered. After speaking with multiple professors NJIT did not allow us access using 3rd party products. Something so simple changed our project. If our group from the start checked to see if all of our products were compatible, we would not have this problem. As a contingency plan we found a user friendly interface through mathworks that allowed us to create a UI and it was compatible with all our sensors.
An example of this was something that I encountered while working on my capstone project. Our project consisted of the use of two force-sensitive resistor (FSR) sensors to provide inputs to scroll through a menu in a smartphone app we were developing. Initially, it was believed that the wiring of the sensors would be an extraneous task and the programming of the sensors and the smartphone app would be on the critical path. Therefore, the soldering of wires to our sensors was a task put off towards the later end of our project after we had finalized and 3D printed a design for the casings that would house the sensor. Unfortunately, when the time came to solder wires to the sensor, we ran into the unexpected circumstance where the thin and delicate nature of the sensor made it hard to solder to its pins without burning the protective cover above its conductive film. As a result, we ended up damaging one of the two sensors while soldering and had to quickly obtain a replacement prior to our final demonstration of our project to our advisor. Since, we had placed this task towards the end of our project schedule, this circumstance put the soldering of the wires on the critical path as we only had a short duration of time to not only obtain replacement sensors, but successfully solder wires to its pins.
Basically, have not been opportune to work in a medical device company, however, every company have their project they work on, so also, do they have critical path that are somehow delayed or skipped during projects for various reasons which most times have led to a project falling apart or delayed.
That been said, working as a Quality Supervisor in a cosmetic company, we get lots of projects done. There was a face mask cosmetic we were working on developing the formula. However, there were two preservatives proposed to be used during the initiating stage of product development - caprylyl glycol and Euxyl K 712. However, the team chose just one of the preservatives called caprylyl glycol which had to be combined with other preservatives like 1 2-hexanediol, ethylhexylglycerin, glyceryl laurate. However, an extensive research was not done to determine if the quantity which was added at 1%W/W will be compatible with the other formula. Also, we never considered when this product is transferred to production for filling what problem can arise.
A line trial was done and the Finish Good was tested which passed analytical testing but failed micro and Repeat Insult Patch Test (RIPT). Microbial counts were found for both the product after been made and on the bacterial and fugus (pseudomonas sp.) when it is exposed or during production when it comes in contact with metal or the fill nozzle used in filling this product. This project could not move to the next stage of getting transferred for manufacturing. We had to go back and make more research. We discovered that Caprylyl glycol though functioning as a preservative against bacteria within oil and water formulations; however, it has limited efficacy against fungi and, irritation when used at a very high concentration. We then had to go back to what was proposed-two preservatives. So, we reduced the % of caprylyl glycol from 1.00%W/W to 0.50%W/W and adding additional preservative - Euxyl K712 at 1%W/W.
Unfortunately, we missed the deadline given to us by the project sponsor but at the long run we got this fixed.
During my senior capstone project, we ran into unexpected issues with regards to multiple purchased pieces of electronics. These issues were somewhat planned for by having testing periods of pieces built into the schedule but overall, we ran into many more issues than anticipated from purchased equipment. The costliest was when our emergency stop button had loose contacts and had to be replaced but was already tested. This caused us to have to go back into testing the equipment and purchase a new emergency stop button to progress. Luckily this only cost us three days but this issue easily could have been worse if the button caused damage to other components to couldn’t be delivered as quickly.
