 Email
for more information
Company's
other products
Email
to a colleague
Printer
friendly format
|
|
Five Questions to Answer Before Leaping Into PAT
By Janice Abel and Dr. Peter G. Martin
At our recent ISPE seminar “Optimization with PAT using metrics that matter,” there was considerable agreement in the audience about the need for better business metrics but it was accompanied by doubt about what metrics actually had to do with PAT. We contend, however, that business metrics have everything to do with PAT. Pharmaceutical manufacturers who implement PAT without a sound way of monitoring its business impact could find themselves very disappointed.
While pharmaceutical manufacturers have been increasingly implementing automation and process control, few if any have been able to use advanced process control and optimization to continuously improve their processes, because it would have required significant re-validation of operations. Some may even have advanced technologies already available to them, but haven’t been able to take full advantage of it. Past validation requirements have reinforced simple, very straightforward automation strategies. A Wall Street Journal writer once characterized the pharmaceutical industry, for example, as being just “behind the potato chip manufacturers” in automation sophistication, mostly because of fear of regulation when implementing new technologies. 1
Now that the FDA has recognized that advanced technologies could be significant in helping the entire industry improve efficiencies, however, gates are wide open for quantum leaps in pharmaceutical production. But with so much opportunity, where do you start? Here are five things you need to know to truly benefit from PAT solution.
1. What is your company’s business strategy?
Are you competing based on price? Time to market? Quality? There will be trade-offs. If you ask ten people at different levels of your company what they believe to be the company’s business strategy, will you get the same answer? Don’t waste time or money on PAT until you are confident that everyone is pulling or pushing in the same direction and that you have organization support of your initiative.
2. How do activities at each level of the company affect strategic execution?
Whether you are in the executive suite, middle management, engineering or on the plant floor, you should have a very specific role in executing the business strategy. If you know the company business strategy as discussed above, can you articulate down to the task what your particular role is in executing the business strategy?
3. How will you measure progress?
How will you know if you have made a difference? Measurement must begin with quantifying business benefits in terms to which top management can relate: operating margins, revenues, costs, OPBIT, ROI, etc. But most manufacturers lack a comprehensive performance measurement system that is aligned with the business strategy. Most engineers and some managers do not calculate or measure the benefits that they bring the company in these terms. The industry itself has done minimal benchmarking of best practices.
Measuring progress may not be easy because the information may be difficult to get; but if you can’t measure your progress, you won’t really know how much improvement you receive, let alone, how you can improve on the value you bring to the company. For too many companies, the metric is something like whether a large division is on target for the month, but that information is usually too late to help you hit that target. Instead you need metrics in real time. We call such metrics Dynamic Performance Measures or DPMs. To develop them, we start with the top level business drivers and then map out the hierarchy of related DPMs that must be attained throughout the company.
The value of being strategy-driven is that you only need to map out those parameters or metrics that are linked to a specific objective. For example, business analysis by one leading pharmaceutical manufacturer indicated that improved solvent recovery would have significant bottom-line impact. By defining measurable incinerator performance improvements and monitoring achievement in real-time via online dashboards, the company accomplished its financial goals and achieved what it called a new paradigm in performance measurement.
4. How will you sustain continuous improvement?
Once you can measure how specific actions impact strategy, how will you reach your improvement objectives? Sometimes, just having the information available in real time will help employees see what they must do to make immediate improvements. Sometimes, improvement can be a matter of improved training or planning. But after that, there may be many instances in which only advanced sensing and control and optimization technologies can result in significant improvement.
This is where PAT comes in. PAT solutions can range from improving control to adding a new sensor or even improving a current measurement. Many PAT related solutions will involve automation of online or at-line sensing and control loops, as in the following examples:
- Adding conductivity sensing to a USP Purified Water system, for example, can signal valve operation to compensate for changes that threaten purity when conductivity exceeds a customer defined threshold.
- Improving pH sensing in a batch operation can eliminate manual sampling, reducing cycle times from hours to minutes.
- Deploying wireless sensors on skids could reduce downtime and costs by eliminating the need to connect instruments and computers to field networks.
The door is now open for model-based predictive control, simulation, and numerous other technologies that have been linked to tremendous productivity gains in other industries, but not yet applied in the pharmaceutical industry.
5. What technology will you implement?
Which technology is right for you? Too often this is the first question that people ask, when it should be the last. If you have answered the first four questions effectively, selecting the right technology to do this is the easy part. Once managers, engineers and operators know how success is being measured, and have had the opportunity to observe their own performance against those measures, they will have a pretty good idea what can be done to help them achieve those measures more effectively. If not, there are outside experts and vendors who will certainly help link a solution to the designated business value or metric, and you will be approaching them as a much more informed buyer.
You may have found, however, that answering questions about business strategy, measurement, and continuous improvement are not all that easy to answer, and the larger your enterprise, the more complicated the situation becomes. The good news, however, is that if approached methodically and with focus on specific operations, the process can be accomplished quite cost-effectively.
In some ways, pharmaceutical manufacturers may have actually benefited by not having invested in advanced process technologies up until now. They will find access to technologies that have already worked out their growing pains. And, if they get to talk to executives as we have, they will learn that implementing any technology independent of a clear alignment with business strategy is at best, a high risk affair.
So while the FDA should indeed be applauded for efforts to encourage the industry to implement technology that could improve manufacturing performance and reduce costs, let us hope that no one interprets this as a call to implement technology simply for PAT’s sake.
About the Authors: Dr. Martin, vice president of performance management at Invensys Process Systems in Foxboro, Massachusetts, is author of Bottom Line Automation and Dynamic Performance Management: The Pathway to World Class Manufacturing (both by ISA Press) as well as numerous articles and technical papers. The Instrumentation, Systems, and Automation (ISA) Society's InTech magazine has named him one of the 50 most influential people in the control industry and Fortune magazine named him a “Hero of US Manufacturing.”
More than 50 companies throughout the world are now implementing one or more programs based on Dr. Martin’s patented "dynamic performance measures” method of providing instant, high-resolution economic feedback of how plant activities are impacting profitability. Dr. Martin has held positions in engineering, product planning, marketing and strategic planning at The Foxboro Company and Invensys Process Systems, and was also vice president at Automation Research Corporation (ARC). He holds B.A. and M.S. degrees in Mathematics, an M.A. degree in Administration and Management, and a Ph.D. in Industrial Engineering.
Janice Abel directs Invensys marketing to the pharmaceutical and biotechnology industries. Previously she was marketing director for Invensys Validation technologies, and the program manager for Foxboro on Electronic Records / Electronic Signatures Program (ER / ES Program) to meet 21 CFR part 11. Janice is the author and presenter of numerous papers and presentations on pharmaceutical topics, most recently on PAT and process optimization. In addition to her strategic business activities, she is actively involved with the ISPE Publications Committee as chair of the Interview subcommittee, Knowledge management task team and the Past Presidents Committee for the Boston Board of Directors. She was also past president of the Boston Chapter. She has a BA from Clark University, an MS in Chemical Engineering and an MBA from Worcester Polytechnic Institute.
References:
1 L. Abboud and S. Henslye. New Prescription for Drug Makers: Update the Plant. The Wall Street Journal, September 3, 2003.
Pharmaceutical Processing
Advantage Business Media
|
