Developing an Application Model for Planning, Controlling, Improving, and Assuring Quality for Pharmaceutical Industry: Covering Quality Planning and Quality Control

Quality tetralogy deals with quality planning, quality control, quality improvement, and quality assurance. This chapter discusses quality planning for standard operating procedure (SOP) in order to plan a new product. Product specification is made on a universal process model. This planning process has six steps, such as establish the project, identifying customer’s needs, discover customer needs, product development, develop process, and develop process controls/transfer to operation. These steps are discussed with their guidelines for the industry. There are many similarities between quality control and quality assurance, but there is only a little difference between quality control and quality assurance. While quality assurance focuses on ensuring that control is maintained, quality control deals with actually keeping control. For quality control, a feedback loop is important. It comprises of sensor, umpire, actuator, goal, and process. There are various problems in developing a process or product, and to solve those problems, the feedback loop is helpful. Plan, do, check, and act are the components of the feedback loop. In the pyramid of control, there are various hierarchies of management and each hierarchy is allotted to work. For the control of the process, there are various planning and stages. The control spreadsheet is an important tool for planning and this spreadsheet is for all the products. Process variation is seen in two ways, such as sporadic cause and chronic cause, and these causes are discussed in the Shewhart control chart. To monitor and analyze variation in process, statistical process control is important. The quality manual is an important document for quality control. In these quality control, a manual procedure is there and that procedure must be approved by an authorized person and then implemented.