When the design controls are not proper, it may cause the project to be set back because the product can not be cleared unless everything is correct. Design controls are in place to have the product design properly so that there will be no mistakes. Also if the design controls are not sufficient, and there is an audit by the FDA, this will not be good. The FDA make sure all the paper work is there and it is correct because it is their job. The FDA will mark down every little thing so missing design control documents will not be a good sign.