This section defines the ongoing assurance that the process remains in a state of control during routine manufacturing. Monitoring must be based on predefined parameters, sampling frequency, and statistical methods appropriate for the process.
1. Introduction Continued Process Verification is the mechanism by which process performance is monitored during routine manufacturing to ensure the process remains in a state of control. It converts process knowledge and control strategy into ongoing, data-driven verification. This stage…
1. Introduction Lifecycle management within Continued Process Verification ensures that process performance is not only maintained but actively controlled as conditions evolve. It defines how monitoring results are translated into actions that preserve the validated state. This includes structured change…
1. Introduction Signal detection within Continued Process Verification identifies conditions indicating potential or actual loss of process control. It converts monitored data into actionable information by distinguishing normal variation from meaningful change. This section defines how statistical signals are identified,…