A process can only be improved when it is described as a process. In most cases the Validation process is described in a set of Standard Operating Procedure (SOP) and Work Instructions (WI). To get a high level overview of the validation process the creation of a SIPOC is a good starting point. The SIPOC should include all type of validation processes used in the company for automation systems. References to SOP’s and WI’s should be made in the SIPOC. All stakeholders and relevant documents must be present in the SIPOC. Together with the SIPOC relevant KPI's must be defined.
When there is no history data available for the KPI’s, it is difficult to define the improvement goals. A project must be defined as a reference and data can be collected on that project.
When the process is described and has reference data targets for improvement can be set in the Project Charter. The Project Charter is defined in this part of the project.
 Lean Validation Project Charter.pdf | [ ] | 33 kB |