As the week comes to an end, the groups are wrapping up their proposals to Dr. Simon and starting the simulation report. This simulation gave groups a good feel on how to modify a verification tests for labels that were falling off in a hot water bath. The simulations instructions emphasized that the Design Specification Document (DSD) cannot be changed and only the verification test plan can be altered. This document contains a detailed list of specifications correlating to all of the design inputs in the Design Input Document.
A hypothetical question I would like to bring forth is, what if you were allowed to change the DSD?
How would your proposal be different if you could change the DSD?
Would you want to change the DSD to somehow pass the 37 C bath test? Or stick with changing the verification test like in the original directions?
If we could change the DSD, rather than the verification test. Our strategy would be different. As the DSD specifies product specs, we could tweak bigger aspects of the product. We could change the adhesive formula, the surface treatment, and how the labels are applied, we could edit these changes to work with our product specifications.
Changing the DSD is usually not the path PMs would use due to its costly and extension of timelines. PM's job is to do whatever project is the most efficient and timely matter possible. SO they will try every avenue from cheapest and quickest to expensive and timely.
DSDs include the key features of the device and outline in which conditions a device can not fail. Therefore, changing the DSD would almost certainly have implications of requiring changes within the verification testing as well. As mentioned in the other reply, you could change certain features of the product that may allow it to perform better under warmer conditions (such as the type of plastic used). When deciding if the DSD should be changed, I think it might also be important to consider what conditions the device is intended to be used under. For instance, is the device intended to be used in temperatures near 37 degrees celsius? If so, then it is critical for it to not fail under those conditions. However, if it should never be used under warmer temperatures, then there is really no reason to test it at that temperature. More so, it would not matter if the device failed at that temperature.
Something that stood out in the process of designing the bottle labels was how it failed criteria at the 37C bath test. Likely what occurred was the adhesive degraded in some form with response to heat, especially considering the labels did not fail criteria within cooler water baths. The DSD did not outline temperature in the criteria given, however it might be important to include said values in criteria. The resources and time used to change the verification test to fit criteria could have been avoided if criteria was more specific to mention temperatures in relation to submersion of the labeled bottles.
In addition, a criteria such as temperature matters when considering potential applications. One application of a higher temperature criteria for the labeled bottles could include being able to send the bottles to be sterilized via autoclaving. AquaWoah coatings are used to coat medical devices, and sterility can be a huge requirement to maintain patient health and safety. Autoclaves use high temperature, high pressure, and water vapor to sterilize products. Failure of a higher temperature criteria in testing would signal failure in this application.
With the simulation given, it is best to change the verification test instead of the DSD for cost reasons, changing of the DSD leading to an extension of the timeline within the project. In addition, this decision can be made based on the lack of specification to where labels are used, assuming generic use. However, specifications should be made to aid in creation of a proper verification test and prevent issues such as outlined in the simulation.
I agree with the points above. Changing the DSD is a more difficult process compared to the test veriffication plan. However, my decision on whether or not it would be appropriate to change the DSD would depend on if it makes sense to expand the scope of the labels to 37C. It would make sense if the bottles are being used in a heated environment and not having the bottles be able to be used there significantly impairs its marketability and function. Something to also keep in mind besides the intended use of the bottle is its distribution. If the bottles are being ditrubuted from the manufacturing site to overseas to a place with higher temperatures, the bottles will be subjected to higher heat. Although they may be meant to be stored in a more controlled environment, such as in room temperatures, this controlled environment is not guaranteed. In this case, it may be necessary to have labels to able to withstand extreme temperatures. If this is the case, it could be worthwhile to expand the scope of the labels. However, as risk assessment would be necessary. Is it better to have a bottle that can only be used in room temperature and limit it's marketability and scope, or is it better to expand the temperature range and therefore the profits?
Hypothetically, if the bottles are meant to be stored in 37C due to its contents, then we can't change the testing parameters. The bottles' labels must be able to stay adhered to the bottle at 37C. In this case, we'd need to change the Design Specs in order to meet passing criteria at 37C. My idea would be to find the cheapest method for increasing water and heat resistance properties for the glue on the label. I'd then test this new method to see if the label will have better adherence to the bottle under water at 37C.
Iff we had the option to modify the DSD, the approach would shift for sure. I do think that changing the verification test alone is a more straightforward and cost-effective route, but altering the DSD opens up possibilities for addressing the root cause of failure, such as improving adhesive properties or changing material specifications.
It would be important to weigh the intended use of the product. So, if the labels are likely to encounter temperatures around 37'C, then addressing the DSD makes sense. In that case, finding a solution for the adhesive could enhance the product’s marketability and broaden its applicability. But if the labels aren’t designed for such conditions, altering the DSD might not be necessary, and improving the verification test could suffice.