Pharmaceuticals came to the continuous improvement table later than some other manufacturing-centric industries, but noteworthy results achieved in the relatively short time since have influenced the industry's approach to manufacturing and allied business processes. Operational excellence and Six Sigma programs were rolling out across the pharmaceutical industry by the late 1990s, but only in the last five to six years have similar initiatives and programs, collectively referenced as continuous improvement, achieved critical mass and industry imperative status.
The pharmaceutical industry was built, and has prospered, on a "hurry up and test" manufacturing model that valued quality but failed to optimize the processes by which quality was achieved. Today's global pharmaceutical industry is the product of rapid and dramatic changes, and continues to evolve in response to market and other shifts. For the long-staid, risk-averse, and change-resistant pharmaceutical industry, embracing the concept of continuous improvement meant radically rethinking the same old approaches.
Albert Einstein wasn't referring to implementing a culture of continuous improvement across an organization as large as Pfizer Global Manufacturing (PGM) when he said, "problems cannot be solved at the same level of awareness that created them," yet this often referenced quote captures the overriding shift in thinking that success in such an endeavor demands.
Historically, quality was the gauge by which pharmaceutical manufacturing processes were measured. For example, PGM had plenty of checks and balances for ensuring quality, but checks and balances alone were not enough to ensure that our manufacturing processes were optimally robust. As a result, we were spending too much time and resources solving problems and not enough time on improvement activities and proactively resolving issues.
A scientific approach designed to foster systemic, ongoing, and value-added change, Pfizer's continuous improvement path began in 2003. Initially focused on understanding and improving the manufacturing processes that directly affected our products, Pfizer's continuous improvement program (incorporating Six Sigma, Lean, and Agile tools, among others) is now being expanded across PGM and into the other divisions and enabling functions of Pfizer.
At Pfizer, all continuous improvement activities are built on five key pillars.
Pfizer's Principles of Continuous Improvement
1. Continuous improvement is a journey of relentlessly seeking perfection.
2. Everything is a process; continuous improvement is not simply limited to manufacturing.
3. Improvement is not judged internally, but by our customers.
4. You must measure performance (cost, quality, speed) to improve the process.
5. Those closest to the work know the issues and opportunities best; get the right tools in the hands of the right people.
What follows is an exploration of how these principles were applied to develop and implement "Right First Time" and Lean initiatives across PGM to instill a culture of innovation and continuous improvement.
THE "RIGHT FIRST TIME" STRATEGY
The "Right First Time" (RFT) strategy, like subsequent Lean initiatives, is a core component of PGM's strategies for ensuring supply and continuing to meet customers' needs. The goal of RFT is to reduce the variation in processes and make them stable and capable of being further optimized. The output of a process cannot be predicted unless the process is understood, and only when a process is understood can risk mitigating or minimizing strategies be devised and optimization achieved. Process understanding, in turn, enables value stream mapping (VSM), a method (incorporated into Pfizer's Lean training) for evaluating the effectiveness of processes (and their effect in a larger system) in a value-added framework.
Pfizer's continuous improvement program is now being expanded across PGM and into other divisions and enabling functions of Pfizer.
To implement RFT across PGM, the perception that it was just another corporate initiative had to be overcome. Getting the right tools in the hands of the right people was essential, as was convincing PGM colleagues of the benefits of using those tools. At opposite ends of the colleague reaction spectrum, small groups of early adopters and skeptics book-ended the silent majority of PGM colleagues in the middle.
Focused on winning that silent majority's confidence and buy-in, the roll-out strategy was three-fold: connect the RFT concept and mission to those of PGM and of Pfizer; demonstrate the active buy-in and support of PGM executive and site-level leadership; and, focus on the core processes of manufacturing, documentation, and laboratory testing.