Chapter 14 - Quality

Abstract

A product's quality is measured by its adherence to or deviation from predetermined quality standards. The challenge is to determine the parameters by which quality can be defined and the product quality assessed. In many industry environments, specific quality standards are required and overseeing that these standards are kept can be a major endeavor. Different environments and project stages have different types of regulations with which to comply; together these are labeled as Current Good Practices (CGXPs). CGXPs include current good laboratory practices (CGLPs), current good clinical practices (CGCPs), and current good manufacturing practices (CGMPs). A product produced under CGXP oversight is expected to be of a certain (approved) quality. A company that develops foods or drugs must adhere to required regulations; in doing so, it must develop and adhere to CGXP compliant standard operating procedures relating to processes, products and performance. To be successful in contributing to the expected quality one must understand CGXP requirements, know which CGXPs apply to one's work duties, comply with relevant CGXPs, read statements of purpose (SOPs), identify and address any uncertainty, and follow SOPs. One must also document his or her work in real time according to regulations, observe and report all data generated, ensure validity of the data, report all aberrant (atypical/unexpected) data and deviations, and assess how to avoid deviations. Most importantly, one should be truthful, take responsibility for one's mistakes, and be a good example for others.