Process Proofing is a systematic series of actions to establish an objective evidence that proves whether a given process consistently produces a desired result or product that complies with predetermined requirements and quality expectations. It is an attempt to understand and abate the risk of process failure through identifying and correcting deficiencies or through selecting an alternative approach to process implementation.
The purpose of process proofing is to assist process performers in understanding quality management requirements concerning process correctness and validation. The activity of proofing a process ends with developing a proofing protocol that demonstrates whether the process is operated properly. It verifies that the process produces a desired product or other result that meets all specifications and requirements consistently over the entire process life-cycle
There are four steps in performing the activity for proofing a typical process:
- Review operational state of the process
- Estimate process performance
- Analyze process results
- Develop validation protocol.