Step by Step

To get your validation Lean a Six Sigma project approach is recommended. This section shows you the 5 project phases of such a project. With each phase a summary of the required actions to get your validation Lean is given.


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.

Download this file (Lean Validation Project Charter.pdf)Lean Validation Project Charter.pdf[ ]33 kB


In this project phase the data for the KPI's is collected. A database system is useful to assist in this, but a most time registration systems will also do most of the job. Using e.g. s SharePoint the project team is continuously informed about the status of the KPI’s and the progress in the project. When multiple projects are measured at the same time, more information will be available for analyses and may lead to more improvements.


The data may be analysed with a statistical package like Minitab. Causes for bad KPI’s will become clear in this phase.

Another activity that is required now, is to detect the waste in the process. Value Stream Mapping is a great help for that. 


All Lean tools described on this Site may be applied now to make the process Lean. Remember the terms •muda (non-value-adding work) and •muri (overdoing). With every step ask Why? (5 times).



The final in this improvement project is to modify the procedures. So that the next validation project is running more Lean.

Keep monitoring the KPI’s and never stop looking for more improvements.