Right the First Time

Last year, New York-based Pfizer launched a radical new program, "Right First Time" (RFT), designed to take it from a reactive approach to a predictive approach to manufacturing and product quality. Leveraging process analytical technologies (PAT) and information technology (IT), the program aims to deepen knowledge of processes, to focus on those that are "critical to quality," and to develop metrics that will allow Pfizer to improve quality throughout its manufacturing operations, documentation procedures, and laboratories. Deep process knowledge, Pfizer believes, will improve product quality, reduce cycle time and improve supply chain management. Pharmaceutical Manufacturing caught up with Robert Miller, Ph.D., Pfizer's director of quality operations for North America and Puerto Rico, to learn more about the program.

Pharmaceutical Manufacturing "What were the drivers for RFT?

Robert Miller - We wanted to get to a point, as far as overall quality, predictability and reproducibility of processes, where no pharmaceutical company has ever gone. We wanted to take a revolutionary step, to move beyond where the pharmaceutical industry is today.

PM  - What is the foundation of RFT?

RM - A very thorough investigative process--a process that allows us to dig much deeper than traditional methods, to help us understand the root causes of variability and to define processes for preventing that variability.

PM - Is this a business process reengineering project?

RM - It hasn't been a top-to-bottom organizational change. Sites have dedicated groups working full-time on RFT. They've dedicated a lot of resources--in terms of both funding and people'stime--and work on very well-defined projects.

PM - How many facilities are implementing RFT currently? How extensively are RFT principles being applied now?

RM - Every one of the company's sites is involved in some aspect of RFT. We've started small: every site has been asked to identify from one to three RFT projects. Some sites have completed the first set of projects and moved on to others, others are still working on the first set, so the involvement varies from site to site. As the program matures, RFT tools, training and opportunities will spread out through each organization. Within the next five years, we hope to get to a point where these won't be specialized projects any longer, but the way we do business.

RM - Most, if not all, of our sites have some kind of Six Sigma black belt training. We're also developing IT-based tools, such as an online system that will allow us to investigate problems or deviations in a process or a lab in a systematic fashion. We're also using a program that takes data and develops more meaningful specifications--internal criteria based on process capabilities.

In addition, on the lab side we are developing an e-compliance platform based on Velquest's software at one of our facilities which will be made available throughout the U.S. on an as-needed basis. On the manufacturing side, we're looking at programs with embedded logic to allow this same automation to be achieved in batch recordkeeping and management. We're also in the process of installing manufacturing execution systems at our manufacturing facilities.

RM - True root cause, determined through a very robust investigative process, makes it easy to determine CTQ attributes. Then, PAT and other capabilities allow you to monitor them regularly. What we're doing is developing a learning organization, where we can take a step back and ask what the data are really telling us--to be diligent and committed to really dig down and get that true assignable cause, then put measures into to place to prevent it from recurring in the future.

RM - Even though it's early in the process, we've already had some successes in reducing reject batch rates and improving our understanding of many of our most challenging processes.

RM - We're working on ways to improve preventive maintenance and calibration, as well as the documentation process. We need to trend, continuously, and understand why values vary, so that we don't merely ask "does it pass or does it fail," but "what is the trend?" For example, are we seeing drift? With drift, equipment may still be operating within its acceptable range, but being able to read into the data and say "Gee, this may be operating within spec, but these data are trending out." I can now anticipate that, within six months for example, based on the trend, it may go out of spec.

Once you see the historical data and trends, you can then take the appropriate corrective action--perhaps work with a new vendor, source a specific type of equipment, or change the way that your facility handles preventive maintenance. The goal is to learn from what you see, rather than take an instrument reading and treat it as a distinct data point.

RM - We'll be eliminating non-value-added documentation requirements. Today, for example, someone told me of a case where we're putting the same piece of data, handwriting it, into four different documents. In another example, in batch records, the person said, they have to make 20,000 entries of the same type. We're all human. When you have those types of processes, the opportunity for failure is quite high.