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Quality is the key determinant that affects the competitive position of products in the global markets. Quality has two dimensions- production quality and service quality. Production quality depends on factors such as design, processes, materials, etc.; service quality depends on factors such as customer relations, communications, delivery schedule fulfillment etc. The main objective of this article is to impart knowledge about statistical quality control at each stage of manufacturing process which helps in controlling defects and variability in manufacturing process thereby improving product's reliability. It also includes steps for designing experiments at each stage for Establishing Statistical Process Control (SPC). SPC is an important method that can be used to measure and control the process. QA at each stage of manufacturing process consists of 6 objectives, which are:- It is also helpful to understand what statistical quality control (SPC) at each stage would be like by inspecting the following example. A pharmaceutical company has prepared one batch of an oral drug with active ingredient Plavix used for treating heart failure. The batch contains 100 capsules of 2 gram each. Each capsule has 10mg of active ingredient Plavix packed in it. A number of samples were packaged in attache cases by this company for sales in US markets. The company performed an analytical error analysis at each stage of manufacturing process for this batch. The analysis is summarized below. Experimental Design : This example is studied to provide an insight into the manufacturing process and to examine how it can be used to control variability in product's performance. Moreover, it will also help identify factors that affect the reliability of the product. By conducting experiments, you will learn how to measure, calculate, analyze root mean square (RMS), standard deviations etc., etc. This will help you evaluate various processes and identify what controls are required to establish effective quality control. You will now be able to design experiments at each stage for SPC i.e. to measure standard deviation of individual measurements or of the process as a whole. Batch Production Process: An oral drug is manufactured by dissolving active formulation in water and filling it in empty capsules. The empty empty capsules are purchased from a pharmaceutical company. The ingredients of oral drug and their quantities are:- Plavix (10 mg) – 1000 gm, Water – 1000 ml and Sodium Hydroxide – 10 ml. In this batch production process, the drug is dissolved in water which is obtained from a well situated at a distance from the manufacturing premises. This water is used to prepare a solution by dissolving Plavix in it. This solution is then filled in empty capsules which are placed at a distance from the manufacturing premises. The empty capsules are then packed and placed for sale. There are various factors that affect the performance of oral drug as follows:- Analytical Error Analysis: Approximately 5% error was detected at various stages of processing i.e., during mixing, dissolving, filling etc. In this example analysis, analysis was carried out at each stage to discover how long it takes to produce a batch of 1 kg quantity comprising 1000 empty capsules with 10mg active ingredient Plavix. No errors were detected at these stages i.e. Statistical Quality Control By Mahajan Pdf Download cfa1e77820
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