BioPharm International - October 2020

BioPharm- October - Regulatory Sourcebook

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52 BioPharm International eBook October 2020 www.biopharminternational.com primary goal. It is the pattern—the emotional scenery—of human hab- its, beliefs, commitments, awareness, and behavior concerning quality" (3). The problem with this definition is that "beliefs", "commitments", and "awareness" are all blurry con- cepts. What manager knows how to directly change the "beliefs", "commitments", and "awareness" of their employees? I needed to find a definition of quality culture that could be connected with actions that could be taken by manage- ment. I concluded that "habits" and "behaviors" would have to do. At least they were measurable. The types of behaviors that we are focusing on here are not com- plex activities. Rather, they are the millions of tasks that happen every day—good documentation prac- tices, correct garb, or proper clean- ing of floors—simple tasks that, if not done correctly 100% of the time, can kill your costs. I'm going to describe the process that we discovered for creating a strong quality culture. I wish that I could tell you that our discov- ery process itself was rational. Alas, no, it was chaotic; slinging ideas at the wall and keeping the ones that work. The end result is elegant. Getting there was not. FORMING HABITS We found that our technicians, the people with their hands on the work, were always busy. They were multitasking, and they were get- ting pulled in different directions. "Hurry up and get that done! But pay attention to details." It turns out that attention is a limited resource. We nd y Wo o d e x p l a i ne d at t h e A m e r i c a n P s y c h o l o g i c a l A s s o c i a t i o n 's 1 2 2 n d A n n u a l C onve nt ion, " T he t houg ht f u l intentional mind is easily derailed, and people tend to fall back on habitual behaviors. Forty percent of the time we're not think ing about what we're doing. Habits allow us to focus on other things … Willpower is a limited resource, and when it runs out, you fall back on habits" (4). We f o u n d t h at e m b e d d i n g quality habits into our employ- ees helps them do it right the first time by off-loading repeated good ma nu fac t u r i ng prac t ice (GM P) activities—such as initial date, fill- in-A LL -the-blanks, no -hair- out- side-the-net—from their conscious to their unconscious mind. When we implant desirable habits into the members of an organization, we drive out undesirable behaviors. The advantage of good habits is that it costs very little to maintain them. Routine, yet quality-critical everyday tasks can be performed with little input from the prefrontal cortex. That leaves plenty of working memory for more complex tasks. T he p r o b l e m w a s t h at o u r employees already had bad habits. Now we had to figure out a way to change them. We knew that would be hard, and that we desperately needed help. THE CAVALRY Frederick Herzberg was a profes- sor in the School of Business at the University of Utah. His research is foundational in the field of employee motivation (5). His research demon- strated that a true motivator is a factor that comes from an internal motor within the employee. Herzberg's factors that motivate employees in order of effectiveness are as follows: • Achievement • Recognition • Work itself • Responsibility • Advancement • Growth. Note what is not on the list: money. It 's not t hat Herzb erg d iscou nted money as a st rong influence on employee behavior. Rather, money can be a powerful demotivator if the employee feels that they are not getting fair com- pensation. Pay ing more money beyond what the employee feels is fair, however, is not a moti- vator i n Herzb erg 's def i n it ion because you have to keep shovel- ing more money in order to keep the employee producing. We didn't have that kind of money. We used Herzberg's two most important factors, achievement and recognition, to motivate employ- ees to change their habits. Both of these factors are far cheaper than Regulatory Sourcebook Quality: Viewpoint Figure 1. Cumulative cash flow. Figure courtesy of the author.

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