I experience scope creep firsthand almost every day at work when quality testing premarket immunoassay instruments. After a particular instrument is built by hand in an assembly line like fashion, my team is tasked to test verify and validate that the instrument works and will meet the customer’s needs. During the testing, which takes around 18 hours per instrument if everything goes well, small conformity/mechanical/ detection issues may be discovered. Once discovered, the troubleshooting process begins which may lead to the discovery of other, smaller issues as well as the main problem regarding the instrument. In one particular example, the way the timing of which the instrument moved the sample from one onboard analytical tool to another was off by milliseconds so the motor had to be re-tuned. It was only when this occurred, that it was found that there was also a sample detection issue which also needed to be fixed. In this case, there was only two fixes that needed to occur to pass the instrument, however I have heard horror stories where 40+ hours was put into fixing all the bugs in particularly notorious cases.

In addition each instrument has individual deadlines that must be met because their shipment and preorders throughout the world have already been established months in advance. Delay on the delivery times would not only look poor on my team’s performance, but the companies as a whole. Therefore, ample time is allotted for this process to avoid most minor delays.