One common problem is in many organizations there is a resistance to approve many of the design documents, because they want them to be flexible and allow change.
Alignment of Design Documents Across Cross-Functional Teams
If the document is controlled then it has to go through an approval process which may be seen as tedious. The point in controlling them is not to restrict the design process, but to ensure alignment across cross-functional teams. It is perfectly acceptable to have revision 1 signed off and being working on the draft of revision 2 and even approve revision 1 with “TBD” (to be determined) values.
Design Control Doesn’t Include Marketing or Feasibility Requirements
The following sections will discuss all of the critical elements of design control, but how to implement them is highly variable depending on the maturity of the organization and the complexity of the product. While most organizations often differentiate these processes, phases and steps into individual SOP’s, it is possible to be compliant with a combination document that includes most, if not all, of the required elements within a single document.