Your manager provides you with a dossier approved by the Ind…
Your manager provides you with a dossier approved by the Indian FDA (CDSCO) and asks whether it can be used as the basis for a new application for registration based on a reliance pathway to be submitted to SAHPRA.What would your reply be and explain the reasoning for your response.
Read DetailsHomer runs a lumber mill and supplies wood planks to a furni…
Homer runs a lumber mill and supplies wood planks to a furniture company for assembly into tables. The furniture company requires their suppliers have a defect rate of no more than 66,807 per million planks produced. The planks need to be cut at a length of 4 ft, with a tolerance of plus/minus 0.05 ft. Before Homer starts to mass produce the planks, he runs a pilot test of the process to determine if it is capable of producing fewer defects than allowed. The average plank length is 4.015 ft, with a standard deviation of 0.066. a) What is the sigma level desired for the process by the furniture company? b) Calculate the Cpk of the pilot test. c) Is the process capable of meeting the sigma level? Show all work to get credit!
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