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.

Hypothetically, if I could change the DSD I would alter the part of the DSD that required that the label pass a submersion test. In the instructions for the simulation the simulation mentioned two products both the hydrophobic and hydrophilic coatings. They also said that the hydrophilic coatings are usually applied onto medical devices, cost more, and require more advanced application techniques. Considering these facts, I highly doubt there is any need for these bottles to stand up to 10 minutes of submersion in water at all. As a high-end product I can understand there might be a need for it not to smear when soaked in water, since as a high-end product it could help the brand image to have that ability. Actual submersion, however, is a completely different case, and I find it highly unlikely that customers, which will mostly be medical companies or hospitals will somehow accidentally submerge the bottle completely at all let alone for 10 minutes. If this was for the hydrophobic product it would make more sense as these are purchased for general consumer use, and people will abuse their stuff in all kinds of ways. If this submersion requirement was removed from the DSD, then the entire verification step that required submersion could also be removed. 

After completing the simulation, I do not believe changing the Design Specification Document (DSD) is necessary to resolve the failed verification test. When I asked if there is a minimum or maximum temperature the product must remain at, Dr. Simon clarified that the coating solution must be refrigerated between 2 C and 4 C or it will degrade rapidly. Given this requirement, the bottles would not realistically be exposed to water temperatures of 37°C in a manufacturing or storage setting. Having this information, the temperature specified in the original verification protocol does not reflect real world conditions. Verification testing should reproduce the actual environments a product is expected to encounter. Because the reagents become unusable when stored outside of the required temperature range, label adhesion at higher temperatures becomes less relevant since the product would already need to be disposed of. If I were to change the DSD, I would modify the specification to state, “Labels must stick to pre-cleaned glass bottles of proper size for the given coating solution or reagent without peeling off when the bottle is submerged in 2 C to 4C water for 10 minutes”.  This would better reflect realistic storage conditions for the product, since any water the labels are exposed to during refrigeration would be within that lower temperature range.

Changing the DSD is not just a technical adjustment, it is primarily a strategic decision that must be taken carefully (As it can be costly and time consuming, and often times is unnecessary depending on the situation to make changes). The DSD exists to lock in design outputs that trace back to design inputs and intended use. This makes the initial question when making changes to the procedure, "Was the 37 degree water bath ever actually a justified requirement in the first place". In this case, the product would typically be stored in an environment of 2-4 degrees, meaning that testing in a 37 degree environment would not correctly reflect realistic use conditions. As SEG28 mentioned, Verification testing should reflect actual actual environments that the bottle would be exposed to, and modifying the DSD to clarify environmental limits would actually strengthen the design documentation because it aligns specifications with real-world handling, and not arbitrary extremes, such as the 37 degree water bath that the bottle is subjected to. At the same time, I would also want to exercise caution about changing the DSD purely because the product failed a test. If the bottle is exposed to 37 degree temperatures during transport, hospital use or cleaning, then adjusting the adhesive or label material would be the more responsible way to go. This is based from a risk-assessment standpoint, as the PM needs to ensure that the requirements reflect possible situations. 

If I were allowed to change the Design Specification Document, my approach would shift from simply adjusting the verification test to questioning whether the underlying design requirements truly reflect real-world use conditions and patient safety. While it might be tempting to modify the DSD just to ensure the label passes the 37°C bath test, I would not support changing specifications solely to make failing results look acceptable, because that would compromise design integrity and potentially regulatory compliance. Instead, I would first analyze whether the specification itself is unrealistic or misaligned with clinical or environmental conditions; if it is scientifically justified to revise it based on evidence, risk analysis, and stakeholder input, then I would formally initiate a controlled design change. However, if the DSD accurately reflects user needs and regulatory expectations, I would stay focused on improving the label material or adhesion performance and refining the verification method within the original constraints. Ultimately, any change to the DSD must be driven by validated data and patient safety, not by convenience or the desire to pass a test.

I agree with Ehab that changing the DSD may not be necessary in this case due to the nature of its stipulations not including that the water bath had to be 37C. Additionally, if the DSD is changed any time a product doesn't pass verification testing, it puts into question the integrity of the device and the DSD itself. It would be faster, simpler, and cheaper to really take a look at the verification requirements or see what can be done about the design rather than editing the DSD. In some cases, customer needs may also limit what can be changed in terms of DSD requirements, as customer needs ultimately define what the product will be and what it has to do.