This month, the FDA is receiving feedback from the pharmaceutical industry on its proposed quality metrics program, which will be a set of metrics provided by biotech and pharmaceutical manufacturers to move the agency’s inspection schedule toward a more risk-based approach and alleviate the chances of drug shortages. Other stated benefits of the FDA’s proposed move to industry-wide compulsory reporting of standardized quality metrics is that it will lead to continual improvement and will allow companies to advertise their successes; for example, they can promote that they’re a Tier 1 or Tier 2 manufacturer. Whether the FDA’s quality metrics program will benefit the industry and make it safer – or just add another layer of bureaucracy and burdensome recordkeeping – is an open question that big pharma is grappling with.
Quality control is already a concern for the pharmaceutical companies I spoke to. I interviewed executives for a profile of the quality culture at Bristol-Myers Squibb that appears in the October issue of Pharmaceutical Engineering and they express confidence in the robustness of their internal QC programs. “At BMS, we’ve been focused on accelerating a culture of quality that transcends compliance,” said Donna Gulbinski, senior VP of global quality at BMS. “Good business is good quality. The lean [manufacturing] quality motto of ‘right first time’ is key for us.”
For BMS, strengthening a culture of quality starts at the top and works its way down through all employees. Andrew Espejo, executive director of strategy at BMS, made it his mission to meet as many of his colleagues as he could when he became the general manager of BMS’s plant in Mount Vernon, Indiana. He instituted Gemba walks on the shop floor so the executive team could see and be seen by the workers at the plant. He also led town hall meetings every month, where employees discussed quality and safety at the facility.
“I met with all my colleagues at the plant,” he said. “It took me nine months to complete. I’d ask two questions, ‘What do you like about working here? What things can we improve on?’, and I’d let the conversation go from there.
“We didn’t focus on cost. The cost savings emerged, but we focused on the potential impact on patients. If you don’t focus on people, on the patients we work for, quality gets lost in the compliance mire.”
It’s this ‘compliance mire’ that concerns some in the industry. It will be the collaborative work of the FDA and bio/pharmaceutical companies to ensure that standardized metrics improve the environment.
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