To create an efficient validation process a SIPOC can be used to define the processes involved in validation. The SIPOC provides a high level definition of the processes. Details of the processes must be defined in Standard Operating Procedures (SOP) and Work Instructions (WI).

In this section the 5 steps of the Project Phase of the Validation process is shown in a SIPOC diagram. The diagram is created from the view of a Pharmaceutical Company that executes a project for a process control system together with the supplier of that system.

When the process is described, the process can be optimized using Lean principles.