I recently read a blog in which the author tells this story: W. Edwards Deming (a “founding father” of total quality management) was getting ready to teach a four day seminar on quality improvement when an executive approached him. The executive said that he was too busy to attend the seminar and he asked Deming to save him time by summarizing Deming’s methods in a few words. According to the story, Deming responded “You should focus on reducing variation.” (1)
How does one go about “reducing variation?” To quote another expert -- the king in Alice’s Adventures in Wonderland(2) -- it is necessary to “begin at the beginning.”
And so, as textbook authors and biotechnology educators, we took this advice and tasked ourselves -- once again – with the project of finding the “beginning.” In our case, this means we again set out to identify and illuminate that which is fundamental in achieving quality in any biotechnology setting. Often, during the years we spent working on the third edition of our textbook, we (Lisa Seidman, Cynthia Moore, and Jeanette Mowery) asked ourselves what we were thinking by taking on this major project. But, during those years, interesting events occurred that inspired us to continue our work.
Deming’s work emerged from studies of quality in industrial production settings. On the surface, industrial production environments seem distant from the workplaces of many biotechnologists, such as scientists in a research laboratory. In a production setting it is easy to understand how product variability can have harmful effects. For example, a drug that varies in its dosage can be life-threatening. A COVID-19 assay that provides inconsistent results is clearly of little value. Reducing variability is, in fact, equally important in a research laboratory but it takes on a slightly different demeanor and we call it reducing “irreproducility.”
An interesting thing that happened between the writing of the second and third editions of our textbook was the introduction of the term “reproducibility crisis.” This term was triggered by various studies showing that as many as 75% of landmark cancer research studies could not be reproduced. As a result, in recent years much attention has been devoted to understanding research reproducibility. Achieving experimental reproducibility requires reducing variability. To reduce variability in the laboratory, it is necessary to “begin at the beginning” with consistency in equipment maintenance, operation, calibration, and verification; properly and consistently prepared reagents; thorough documentation; and so on. Both earlier editions of our textbook addressed the basic practices required to achieve reproducible results. This edition even more explicitly discusses the relationship between fundamental practices and reproducibility in a laboratory setting.
Another significant event in recent years was the intrusion of a devastating pandemic beginning in 2019 and extending through the writing of this book. It is hard to imagine anything that could more dramatically demonstrate the importance of biotechnology than this pandemic. It is only because of the work of biotechnologists that we have a pathway out of the pandemic that does not involve millions more deaths. Even as we laud the sophisticated scientific advances relating to the pandemic, we also see how fundamentals influenced the course of events. Consider the delay in introducing PCR COVID-19 tests in the United States that was caused by contamination in the facilities of the Centers for Disease Control and Prevention. It was not sophisticated science that tripped up the CDC scientists. It was failed aseptic technique, a fundamental biotechnology practice. It is such fundamentals that we explore in our text. The incredible scientific achievements during the pandemic are built on a foundation of basic, good laboratory practices.
We are happy (and relieved) to announce that the third edition of Basic Laboratory Methods for Biotechnology: Textbook and Laboratory Reference(3) was published by CRC Press at the beginning of this year. Additionally, the second edition of Basic Laboratory Calculations for Biotechnology was simultaneously published. The calculations text focuses on basic calculations, such as those involved in preparing reagents, or setting up a reaction mixture. The calculations book is gently paced to provide support for beginning students or self-study for beginning professionals. Both of these texts are now available as inspection copies for instructors (4). They are also available in paperback, hardback, and as e-books. A third text, a laboratory manual to introduce students to fundamental laboratory techniques, is nearing completion as an on-line manual. Once on-line, the laboratory manual will be freely available to students who have purchased the Basic Laboratory Methods for Biotechnology text. Also, the calculations text will be available less expensively when bundled with Basic Laboratory Methods for Biotechnology.
As a final note, we will be presenting an InnovATEBIO webinar on May 13 that will address variability/reproducibility in an educational laboratory setting. Over the last 10 years we have been teaching a class in basic laboratory methods to participants who already have at least a BS degree in biology and who often have graduate degrees or industry experience. Through the years, the participants (and instructors) have learned much about how variability stealthily creeps into basic laboratory tasks. We will enjoy sharing our experiences and insights with the InnovATEBIO community in this webinar.