Question: In addition to evaluating if the process was under control (meaning there is no special cause variation occurring), Tyrone decided to assess the process capability
In addition to evaluating if the process was under control (meaning there is no special cause variation occurring), Tyrone decided to assess the process capability to see if the machine was generating defects above the specifications. He decided to verify if the process was capable of producing at the 3-Sigma Level capability that Pharma promised its customers. He used the same dataset to calculate the Capability Ratio and Capability Index. The standard deviation was 0.04. FDA restricts the 10 milliliters syringes to have a lower specification limit of 10 milliliters and the upper specification limit of 10.3 milliliters. At that time, he was setting the machine to produce syringes with an average of 10.1 milliliters. By collecting data for the process capability analysis, he realized that the process was not mean centered, as the x-double bar was 10.1 milliliters and the center of the specification limit was 10.15 milliliters. Tyrone also wanted to test if the process was capable of producing 3-sigma level if he decided to increase the target average filling of the machine to 10.15 milliliters. He expected that the standard deviation would not change. In addition, he decided to retrain all his employees in how to set the machine in order to prevent future quality problems from happening
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