I had completed my undergraduate degree at NJIT and remember creating the requirements document and the test plan. I remember how detail oriented, yet concise those documents had to be and being so frustrated when completing them. As my advisor used to say, “the devil was in the details”, and this phrase could not apply more to those documents. Every single aspect of our capstone project had to be specified in our requirements document. For every requirement, there was at least one test within the test plan as well, and in the moment, it seemed like too much. However, after taking this course and reading the other comments in this topic, I am glad to have done those documents in such detail. I did not realize it then but completing these documents in my capstone class were preparing me for industry.
This week's discussion reminds me a lot of what we had to learn in our capstone design class senior year. The three biggest deliverables for that class other than our powerpoint presentations were the two documents that we had to turn in: business requirements document and the test plan document. The business requirements document was a direct representation of the customer needs. We met with our customer, asked what he wanted his device to have and the constraints, and then we determined how to create a device that fulfilled all these requirements. This document was long and was to specifically list every single aspect of the device and be so detailed that if carrying out and following every requirement, the device can be made perfectly every time.
The test plan document is a supplement to the business requirement document. The test plan is meant to take all the requirements and introduce a test architecture to determine whether all the values in the requirements represent the device.
It is common for a device to go through all these steps before it can be mass produced and sold. Everything has to be perfect because of that and the constant trial and error of making it is difficult and takes a decent amount of time.
I have noticed, since taking senior design and working, that the test plan is very important. In terms of design documents, the test plan can help satisfy the DSD or Design Matrix. This is because it is needed to determine some of the specific characteristics of a product, for example with a suture for a medical device, one specific property that should be determined is straight tensile force and one way to test that is by using an Instron mechanical testing machine. This is incredibly important if the suture is going to be subjected to a certain amount of tensile force regularly and must meet a minimum criteria every time. This is information that regulatory can leverage in their submissions to help get the product approved. Marketing can also use this information by running comparison studies and claiming that their product is superior to their competitors and highlight a specific value (like straight tensile strength).
Does anyone else work in a similar field that has noticed anything else that is very transferrable?
Thanks,
Matt
I think for the most part yes, it is common for a device to go through all of these steps. However, I think, you might have to go through more steps and more documentation. I feel like the projects we worked on are not as complicated as the ones in industry. You will see too though. Also, some of the documents might be modified depending on the project and industry you're working in.
