Thesis (Ph.D.) - Cairo University - Faculty of Faculty of Graduate Studies for Statistical Research - Department of Statistical Quality Control and Quality Assurance

To survive in a competitive market, improving quality and productivity of product or process is a must for any company. For the release of pharmaceutical products into the drug market; most of the pharmaceutical companies depend on acceptance criteria - that are set internally, regulatory and/or pharmacopeial Specifications.This study is about to apply Lean Six Sigma in the production processing line and on final product to reduce defects by identifying where the highest waste is occurred at and to give suggestion for improvement.The approach used in this study is direct observation, thorough examination of production process lines, information has been collected from potential customers (internally and externally) and company{u2019}s workers through internal complains and product return and exploit these data in cause-and-effect diagram, Pareto chart/analysis and control chart (p-chart) and effective brainstorming sessions. It has been found that the company has many problems; specifically, there is high rejection or waste in the production processing line, high customer complaints and high non-conformity from the QC and IPC department From Aerosol Production Line due to Leakage test Failure and Out of Specifications. And it was found that the blisters, vial, and ampoule physically are out of specifications as well.The major causes of nonconformities and root causes of the quality problems were specified, and possible remedies were proposed. Although the company has many constraints to implement all suggestion for improvement within short period of time, the company recognized that the suggestion will provide significant productivity improvement in the long run

Issued also as CD