Process control Flashcards
A key part of the PQR is a review of process control. Cp and Cpk are two tools that can be used for this. Can you explain what these are and how they help you describe a process as part of PQR?
Short term variation - Cp shows whether the distribution can potentially fit inside the specifications. CpK shows whether the overall average is centrally located. It is used to measure the ability of a process to product output within the specification limits.
What limits tell you if a process is capable or incapable?
A CPK value of 1.33 is considered acceptable. A cpk value of less than 1.0 is considered poor and the process is not capable. The higher the cpk the better the capability of the process