Risk based decisions during Change Control may have a big impact on the validation effort. For a PCS there is a big difference in changing a symbol on a process graphic or changing the fermentation operation. A complete description of a Lean Change Control process is described in another section. In the Change Control process the following items shall be Risk Based:
- Type of change
- Change actions
- Testing / Qualification
The following diagram shows a relation between the type of change and the required actions for that change.
The next diagram shows the relation between type of change and the required signatures.
An example of a Risk Assessment form for changes for a PCS is attached.