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Pharmaceutical Technology REGULATORY SOURCEBOOK DECEMBER 2019 7 and included having formal programs in preven- tive maintenance, risk management, human error prevention, training, and continuous improvement (5). Results of that study enabled the development of a quality culture assessment tool that PDA has used to train 50 firms and more than 100 regula- tors in the United States and Europe, according to PDA task force leader Cylia Chen Ooi, director of quality at Amgen. Observers see the need for pharma to expand its definition of quality. "Compliance, rather than a tradition of operational excellence, remains deep in pharma's DNA," says Nuala Calnan, founder and principal of Biopharm Excel and a member of Dublin Institute of Technology's (DIT) regulatory science team, who worked on the quality culture metrics program with PDA and St. Gallen. "This mindset presents a significant barrier to excellence and must shift if the industry is to move beyond inspection readiness to true patient focus," she says. The past decade, marked by mergers, down- sizing, offshoring, and increased competition, has provided the industry with a number of negative examples of quality culture, for example: • The quality department of one Big Pharma over-the-counter (OTC) drug subsidiary in the US, whose managers allegedly coerced quality control (QC) lab analysts into passing failed batches. The department was unoffi- cially nicknamed "EZ Pass" (6). Senior man- agers at the company were ultimately sued for failure to fund adequate QC, resulting in a $22.9-million settlement (7). • Two Indian pharmaceutical companies, which fired workers after their facilities re- ceived warning letters from FDA (8). • Operators and technicians at a number of In- dian and Chinese manufacturing facilities in 2014–2017, who, during FDA site inspections, reacted to auditor requests by shredding doc- uments, pouring samples down the drain, or removing a memory stick from a computer and running away with it (9). FDA has noted document shredding as recently as 2019 in a warning letter citing deficiencies at a facility in India (10). Observers see the need for more proactive phar- maceutical company managers who actively sup- port and invest in quality efforts and employee training. Toyota's quality leaders often discussed the need for senior managers to walk the manufac- turing, research, and testing laboratory f loors (i.e., the gemba, or, in Japanese, the place where truth will be found) to learn directly from employees what the day-to-day problems are, to coach them, and work with them to find solutions. "For gemba to work, managers must talk while they're out there, not telling but listening, observing, coach- ing, and enabling employees by removing barriers," says Calnan. Walking the talk More pharma companies are encouraging this ap- proach and shifting to peer-review models with leaders being made more accountable and visible. Observers see the need for more proactive pharmaceutical company managers who actively support and invest in quality efforts and employee training.