Principles of Continuous Quality Improvement

This section discusses the technology that provides the foundation for quality improvement Process technicians use this technology as a valuable component of the continuous quality improvement team. 

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The principles of continuous quality improvement include innovation and improvement of services, products, and processes integration of suppliers and customers into the quality process use of quality tools audit and evaluation provision of continuous quality improvement training to all employees, unrelenting commitment to quality and involvement of all levels in the organization and documentation. 

PSM buiids on what is in piace, and seeks to integrate safety issues into ongoing business operations"as opposed to imposing an eiaborate exter-nai structure. The goais of PSM are process-oriented, not procedure-driven, and reflect the Total Quality Management principle of continuous improvement. 

The management believes in the effectiveness of a quality assurance system based on complying with the provisions of ISO 9003 and our principle of continual progress through defect prevention and improvement. This system is managed by our quality assurance department, whose role is to implement and maintain a structure and control its evolution in order to ... 

Life cycle management and change control provide a mechanism for continuous improvement. To support continuous improvement through change control a quality system would need to be based on principles of manufacturing science and risk-management. The proposed ICH QIO guidance is an opportunity to accomplish this task. 

Programs that regularly apply these principles in a process of continuous improvement demonstrate a culture of quality. 

Review the management principles of Juran and Deming and identify how safety can be part of continuous improvement and quality. 

A quality management system (QMS) is an important tool for process control and continual improvement. After a brief section about development of the quality principle in the preparation of medicines over the years, this chapter lists the processes in preparation and in the manufacture of medicines that have to be controlled. A medicine, whether developed in a pharmacy or in industry, starts with defining the needs of the patient. Then the formulation and the method of preparation are designed to meet product specifications. The next step of the product life cycle is the production, including quality control and release. 

Principles of Quality—course covering the background and application of quality concepts. Topics include team skills, quality tools, statistics, economics, and continuous improvement. Focuses on the application of statistics, statistical process control, math, and quality tools to process systems and operations. 

We found that the following principles were key to the successful implementation of an OBMod approach to quality improvement in a continuous process production environment ... 

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