The pharmaceutical industry is one such field in which quality prevails more than any other thing.

Pharmaceutical industry: heavily dependent on Lean Six Sigma

Six Sigma is a term that was coined by a Motorola company engineer Bill Smith in the 1980s. This term has allowed improving the business processes, product quality, and overall financial performance of many companies in different sectors.

The pharmaceutical industry is one such field in which quality prevails more than any other thing. The reason being that all the goods manufactured are concerned with human health. Although quality first is the motto of this industry, it has failed to achieve six sigma quality even when other industries have achieved it long before. Consultant and statistician Ron Snee feels that the failure to implement lean six sigma in pharmaceutical companies is due to the misunderstanding of the concept itself as they consider the term as a medium for quality improvement or just as a part of training when it should be an overall effort to improve organization performance.

Product recalls are instances in which the manufacturer or the company has to withdraw its product from the market due to the discovery of safety issues or defects that may endanger the consumer. The USFDA, in 2018 itself has ordered 13 product recalls of medicines until March and more than 50 in 2017. For a quality driven pharmaceutical industry, this is a total nightmare because the company has to suffer losses as well as there comes a shortage of medicines in the market that affects the patients. According to Lawrence Yu, deputy director of OPQ, CDER, the FDA has to assume the role of the devil for the companies only to give the best quality efficacious medicines to the consumers and to prevent horrible incidences like the Sulfanilamide elixir tragedy of 1937 and the Thalidomide tragedy of the 1960s.

The companies also now have started implementing strategies to achieve six sigma quality, like Quality by Design, Process Analytical Technology, Current Good Manufacturing Practices for the 21st century, and Emerging Technology. Yu suggests that companies must commit to quality-focused efforts, use process capabilities and a culture of quality and continuous improvement to achieve six sigma quality. The FDA also must support such companies.

Activities focused on patients and collectively embracing a culture of quality by every employee is a must. Once these practices are inculcated in everyday jobs, only then the USFDA Pharmaceutical Quality for the 21st Century Initiative aim of promoting a maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high-quality drugs without extensive regulatory oversight will be achieved. Only then will the pharmaceutical industry grow from a two or three sigma quality industry to a giant and capable six sigma quality industry.