It is impossible to mention quality control without at least one sentence on quality assurance. Quality control itself is the process through which a medical device or pharmaceutical manufacturer ensures that the product quality is maintained and adheres to a defined set of quality criteria or meets the requirements of the client or customer. This post takes a deep dive into quality control, quality control charts, and how using an X-bar chart can be a significant factor in achieving greater quality control of life science manufacturing. Used in conjunction with its partner, the R-chart, the X-bar chart offers quality control personnel a way to analyze defects or variations of a process from a grouping of samples. While quality control tools take different forms, one of the oldest and most indispensable is the X-bar chart. The WHO defines quality control as “the sum of all procedures undertaken to ensure the identity and purity of a particular pharmaceutical.” Therefore, effective quality control procedures are absolutely essential in medical device manufacturing.
Establishing and maintaining quality control in life science manufacturing is of paramount importance because it can directly affect a patients’ health, quality of life, and even their life itself.
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