What is the sigma of this process, and how many doses would be above 5 mg in 1,000,000 doses produced?

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Logistics and Supply Management

Part 1. What is the difference between a specification limit and a control limit?

Part 2. A pharmaceutical manufacturer requires between 3 and 5 mg of medication in each dose of cancer medication. The mean of the process is 3.75, and the standard deviation is .25. What is the sigma of this process, and how many doses would be above 5 mg in 1,000,000 doses produced? What would this mean for real patients in terms of underdosing or overdosing?

Part 3. Which pharmaceutical manufacturing process below process is ‘capable?’ In other words, which process is a 6 sigma or better process?

LSL: 3

USL: 5

Process 1. Mean of 4.5, standard deviation of .08

Process 2. Mean of 4, standard deviation of 0.5

Part 4. What are some of the concepts / math that are either causing you issues or that you feel you have mastered?

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