If there is no way of mapping out how the device was made, the effects can be very detrimental. If something were to go wrong, there needs to be way of tracing back and figuring how/what went wrong and if there’s anyway to rectify this mistake. The FDA wants to make sure that the manufacturers are held accountable for everything regarding their product. If there are insufficient design controls, your company can be in serious trouble because there is no outline that describes the process of how your product was made.