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Process performance qualification protocol is a component of process validation: process qualification. This step is vital in maintaining ongoing production quality by recording and having available for review essential conditions, controls, testing, and expected manufacturing outcome of a production process.
The process capability is a measurable property of a process to the specification, expressed as a process capability index (e.g., C pk or C pm) or as a process performance index (e.g., P pk or P pm). The output of this measurement is often illustrated by a histogram and calculations that predict how many parts will be produced out of ...
A process capability analysis may be performed on a stable process to predict the ability of the process to produce "conforming product" in the future. A stable process can be demonstrated by a process signature that is free of variances outside of the capability index. A process signature is the plotted points compared with the capability index.
Top level Configuration Management Activity model. Configuration management (CM) is a management process for establishing and maintaining consistency of a product's performance, functional, and physical attributes with its requirements, design, and operational information throughout its life.
Consider a quality characteristic with a target of 100.00 μm and upper and lower specification limits of 106.00 μm and 94.00 μm, respectively. If, after carefully monitoring the process for a while, it appears that the process is out of control and producing output unpredictably (as depicted in the run chart below), one can't meaningfully estimate its mean and standard deviation.
Each of these documents supports a major design approval decision each with gradual improving design maturity A, B or C. The sponsor is the single focal point for all three documents. The Initial Capabilities Document (ICD) defines the capability need and where it fits in broader concepts, ultimately supporting the milestone A decision.