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68 Pharmaceutical Technology Regulatory Sourcebook October 2020 P h a r mTe c h . c o m Quality: Viewpoint Work teams The employees were grouped into their regular work teams (production shifts, shipping/receiving, labora- tory, engineering, etc). Each team was asked to think of something that they did that affected GMP com- pliance. They were then asked to develop SMART goals—Specific, Measurable, Attainable, Relevant, Time-bound—that, if achieved, would result in im- proved GMP compliance. The fact that the goals were team based encouraged the employees to help each other to achieve the goals. The critical aspect of the goal setting process was that the goals for each team had to be something that the individual team had control over. They could not change controlled processes without following our change control procedure. Some of the managers struggled when the time came to free the teams to work toward achieving the goals in their own way. With repeated achievements, though, the managers learned how to provide enough room for the teams to find their own way to success. They discovered that the teams felt more ownership of the results and were more likely to comply with the procedures that they had shaped. As the teams progressed toward fulfilling their goals, they charted their improvement. The charts were posted in visible locations, thus providing proof of their achievements, one of Herzberg's true em- ployee motivators. Management invested their time to support the process. This consisted of effortless things, like asking random employees how the process was going, then removing barriers as necessary. The most important job of management was to show up—in person—to recognize the achievements of the teams. This could be something as effortless as serving ice cream to the packaging crew when they had achieved their goal of peer-to-peer garb inspec- tions when entering the cleanroom. Results Did the program work? Yes, for example: • The rate of perfect batch records was improved from 70% to 99+% in the second year. A perfect batch record means no GDP errors. • In the third year, first-pass quality yield im- proved from 91% to 96%. Figure 1 shows the cumulative cost/savings for the project. The costs are primarily employee hours. It's important to note that this effort is not a get-rich- quick scheme; it is an investment in the people and the organization that takes time. It is not expensive, however, requiring approximately an hour per week per employee, including managers. Another benefit, which is not readily measured, is very tangible. Managers learned how to delegate better. Many of them overcame that one roadblock that was preventing them from taking on more responsibility. References 1. FDA, Request for Quality Metrics, Guidance for Industry (CDER, July 2015). 2. A. Harrison, S.J. Schniepp, Pharm Tech, 39 (9) 22–25 (2015). 3. J. M. Juran, A. B. Godfrey, Juran's Quality Handbook, 5th Edition, McGraw-Hill 22.65 (1999). 4. D. T. Neal, et al, Personality and Social Psychology Bulletin, 37 (11) 1428–1437 (November 2011). 5. F. Herzberg, "One More Time: How Do You Motivate Employees?" Harvard Business Review, January 2003. PT Figure 1. Cumulative cash flow. FIGURE COURTESY OF THE AUTHOR.