In the company that I work for, we interchange the term “Design Control” and “Document Control” because everything in design control is detained in documents called Standard Operating Procedures (SOPs). So when design control fails, it means we have taken a detour for the procedure. This introduces variability or failure in production. This could be batch variability or the whole production variability. Batch variability could go unnoticed if the batch being tested passes but other batches are not functioning properly. Either way having variability in production means that we literally don’t have control or full knowledge over the end design and product, this is a major failure in productions first of all, costing the company a fortune. If somehow it slips out of the company, it could also pose a potential risk and harm to customers using the product, which will strike back at the company. Therefore, a lot of damage is done to the company and the customer when design control fails.