The Model T Ford is still discussed in business schools today because of how Henry Ford relentlessly drove quality and innovation. When first introduced in 1908 the Model T cost $825; by 1916 it cost $360. While reducing the cost by more than half, Ford increased the safety, reliability, and speed of the product. His laser-like focus on quality was legendary and his quote “Quality means doing it right when no one is looking”, is still a mainstay of quality theory and practice.

Whether manufacturing cars, supplying clean water, or manufacturing pharmaceuticals, all repeated processes must include quality control to ensure products meet their defined requirements. Quality management is very often about measuring and minimising variance within and across batches to ensure adherence to acceptable limits. This in turn is all about keeping meticulous records, as well as managing and accessing that data.

Pharmaceutical Manufacturing Issues

The FDA (U.S. Food and Drug Administration) keeps a public record of the warning letters that they send out to Companies and the citations they contain.1 Looking at the last five years of data provides useful insight as to the main issues they see when inspecting quality control regimes in pharmaceutical manufacturing companies. The data shown here is sifted to report only on the primary GMP regulations for drugs (FDA 21 CFR 211). The FDA data dashboard2 also has some caveats regarding the completeness of the data. Nevertheless, the data provides good insight as to their overall findings.

The top 10 GMP Drug Inspection citations for FDA financial years 2018–2022 are shown in Figure 1. This provides a summary of the issues they found. A description of each CFR number is provided in Table 1.