Janet Woodcock was quite clear in her 2013 plenary speech at the national ISPE meeting in Washington, D.C. The Food and Drug Administration (FDA), she said, is interested in creating a quality culture inside organizations “from the shop floor to the boardroom.” This is not a new message, but the urgency for doing it is being translated into action, with the addition of hundreds of millions of additional budget dollars to the FDA budget in 2014 from the GDUFA (Generic Drug Users Fee Amendment) statutes, at a time when most government agencies are seeing budget cuts¹.
The vision of a quality culture across an entire organization is even more critical to FDA for both the pharmaceutical industry and their contract manufacturing organizations (CMOs) to execute than ever before, given that global manufacturing supply chains are used to manufacture 70% of the generic prescriptions used by the U.S. public every day. The FDA is going to “measure, incentivize and reward” the companies that implement a quality culture. And what the FDA says, industry executes.
WHAT ABOUT THE LINE WORKER?
So the question becomes: What is meant by across an entire organization when discussing quality culture? After all, don’t we usually hear that to be successful, a company’s strategic vision must be driven from the top, and communicated articulately, with passion and vigor, by a company’s CEO down through the organization? There are hundreds of examples of great companies whose CEOs are synonymous with a company’s excellent execution of a CEO’s vision. Think about the late Steve Jobs of Apple, or James Dimon, CEO of JP Morgan Chase, both dynamic speakers with clear and passionate vision. But what about the line workers — the operators and technicians who make the products? Do you think they’ve heard the speech? In the pharmaceutical and medical device manufacturing industry (which have huge levels of manual interventions), it is obviously more critical that those who are charged with “making safe and effective medicines and devices for the public,” understand what a quality culture truly means for them, in their jobs, every day.
As we have moved two centuries beyond the Industrial Age and decades past the age where U.S. manufacturing dominated the global economy, it might be expected that there be less attention paid to the role of the hands-on manufacturing, shop-floor employee. How often do we hear about a strategic vision being executed from the workforce of an organization? Yet, how can a true quality culture, developed to manufacture safe medicine, exist without the buy-in and understanding of the hands that are producing those products — the workforce operators and technicians?
In this era of a globalized manufacturing industry, it’s imperative that strategic vision be focused from the bottom up. There are guidelines already in place, of course, through Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMPs). But these are not enough, as evidenced by an unacceptably high level of product recalls, which impacts the continuity of supply of key drugs and devices to the public. SOPs are looked at early on when an operator learns a process, but blind repetition of said process does not lead to continuous improvement; instead it can breed boredom and the likelihood of mistakes over time. Poor handling and a laxity of attention to following the SOPs are not deliberate — it may simply be a lack of knowledge and the lack of a quality culture that encourages learning more about the “Whys of cGMP” that underpin the “How of SOPs” in making safe and effective medicines.
There is value in educating technicians and manufacturing employees to better understand the Whys of cGMP. FDA comments aside, it is simply good business to address a continuous quality improvement mindset, and to institute consistent quality-based learning — learning that goes well beyond senior operators demonstrating SOPs to the junior operators in a plant. Instead, linking your operations to the good science and good data on which those processes are based, and showing all employees why processes are performed the way the SOPs are written, creates an environment that invites your manufacturing staff to interact, question and potentially spot quality risks before they become a problem.
COMMERCIAL ADVANTAGES FOR CMOs
CMOs in particular will find a real advantage in the marketplace if an operator education program is visible, measurable and consistent. Showing existing and potential new pharmaceutical partners that such training is in place can be a true differentiator when tendering for business. While their pharmaceutical clients will audit and verify the quality and safety of products being produced on their behalf, few will mandate training programs for their CMO’s operators even though they often have in-house customized training for many in-house, manufacturing-specific scenarios. So CMOs need to be able to step up to the plate themselves and show their own commitment to quality training programs for their operators and technicians and demonstrate the added-value of their overall commercial offering rather than simply its price when trying to expand their customer base.
To truly showcase a company’s dedication to quality culture, the manufacturing floor operator training must go beyond just an understanding of SOPs, to more comprehensive understanding of the “Whys of cGMP.” Gerry Creaner understands this very well. As CEO of a company that uses short, precise videos to convey the quality message to a global audience in pharmaceutical and medical device manufacturing, GetReskilled’s CEO says, “Where FDA is focused, industry will align.” He goes on to say that “early adopters of this comprehensive view of quality culture development are clearly going to benefit from the FDA’s stated intention to measure, incentivize and reward those companies that implement a quality culture. The pharmaceutical industry has been mandated for some time now with the intent to build continuous quality improvement into their manufacturing, now that their quality culture is going to be measured, it’s going to happen from the ground floor up. And as sure as night follows day, rankings of companies and their manufacturing locations (however they enter the public domain) will drive this initiative.”