Statistical process control (SPC) is essentially a combination of two different but directly linked statistical tools; (a) capability analysis, (b) control charts. Capability analysis provides information on the ability of the process to meet specification; while control charts must be used to ensure process stability and that the goal of optimum capability, is achieved at all times.
SPC is used in all manufacturing industries, and SPC control chart are also used to identify trending in laboratory data. In the pharmaceutical industry SPC is often referred to as Continued Process Verification (CPV). The FDA has identified CPV as an essential third phase of process validation, providing “continual assurance that the process remains in a state of control (the validated state) during commercial manufacture” – FDA Guidance for Industry, January 2011. This objective is achieved through the use of SPC control charts. Pharmaceutical plants worldwide are urgently gearing up to implement control charts on the production line in order to meet the goals of CPV set by the FDA.
Cp/Cpk and Pp/Ppk are two sets of indices commonly used as measures of capability. There is a high degree of confusion across manufacturing industry as to the relationship between these two set of indices, and the specific circumstances in which each of the two sets should be used – they are frequently used incorrectly. Major emphasis will be placed during this course on providing delegates with a thorough understanding as to why there are differences between the two set of indices, and their appropriate usage.
Statistical process control is most usually associated with measured product characteristics; the resulting data is usually known as variables data. However, SPC also has a major role as a tool for the monitoring and control of manufacturing defects (commonly known as attributes). The control chart for attributes provides personnel with responsibility for quality of product with crucially important information, which will assist them in controlling and reducing the incidence of defects. There are four types of attribute control charts and use of these will be described during the training course.
Many people who use the capability indices such as Cp/Cpk and Pp/Ppk when determining capability of their processes, are unaware that the indices Cp/Cpk are mea...
It is quite common for quality personnel to undertake 100% inspection when checking for presence of defects in manufactured products. As a consequence, the samp...