Article Revised: March 27, 2019
A student in my Lean Six Sigma Black Belt course who works in the pharmaceutical industry was concerned that improvement methodologies such as Lean and Kaizen conflicted with the Current Good Manufacturing Practices (cGMPs) established by the Food and Drug Administration (FDA.) However, there is no conflict between cGMPs and Lean, Six Sigma or any other process and quality improvement methodology. In fact, the “c” implies change and improvement. According to the FDA web site:
The flexibility in these regulations allows companies to use modern technologies and innovative approaches to achieve higher quality through continual improvement. Accordingly, the “c” in cGMP stands for “current,” requiring companies to use technologies and systems that are up-to-date in order to comply with the regulations.
Changing a system that is producing output that complies with FDA and other requirements is inherently risky, and certainly precautions must be taken to assure that any change does not adversely impact public safety or health. However, this is not to say that no change is allowed. It simply means that changes must be designed with care and implemented in a way that assures that consumers are protected from harm. The improve and control phases of the Six Sigma project execution framework already incorporate these considerations, but where human health and safety are involved these two phases assume additional importance. Of course, it goes without saying that compliance with all regulations is a requirement of any new or improved process. In some cases FDA approval of the change might be sought prior to its deployment.
cGMPs define quality requirements very broadly. They do not specify the particular process that must be used. Similar quality standards have been in existence since soon after World War II and they have not impeded continuous improvement efforts in any significant way. Lean itself incorporates standardization of work as an important element. But while standards define the currently acceptable approach to producing goods and services, they are not intended to be unchanging. As new and better ways of doing things are discovered, they are incorporated into the standards. We move from one approved way of doing things, to an approved better way of doing things. Lean Six Sigma helps us find those better ways.