The question facing some users is, “Do I fund and staff a one-time effort to redo my control system applications to conform to S88?” or “Do I develop a custom S95 implementation that requires an unpredictable amount of resources to maintain and update?”
Of course, there’s no single right answer, but at least part of the best decision for you lies in how you answer the following question, “What would be the impact on my current control system application software if my company decided to begin producing a completely different product using the existing equipment and piping in this facility?”
If the facility was S88-conformant, the changes would occur at the recipe level, and the existing instrumentation and control system validation qualifications would remain unchanged. That sounds simple, but the impact is huge, especially when measured in time to market.
One more set of letters in this alphabet soup remains to be discussed—PAT. Though the PAT initiative is officially targeted at FDA-regulated processes, its goal is universal throughout the process industries—to enhance the understanding and control of the manufacturing process in such a way that product quality is designed in.
When it comes to compliance to U.S. FDA regulations, cost is a major driver for companies in the life-sciences industry.
Prior to the FDA’s August 2002 announcement of Pharmaceutical Current Good Manufacturing Practices (cGMPs) for the 21st Century, companies conducted quality testing of veterinary and human drugs and select human biological products after the products were produced. This post-production quality testing practice adds cost in the areas of product scrap and rework, “in-process” inventory management, and delays in shipping finished product.
PAT, a key element in the FDA’s announcement, aims to increase the likelihood of defect-free pharmaceuticals by applying a risk-based approach that combines in-situ and other in-process quality measurement technologies alongside best practices that are designed to identify out-of-spec conditions as early in the production cycle as possible.
Referring to Figure 1, we see that MES software provides a solid framework for achieving the FDA’s goals for PAT. Though MES software is not likely to provide the entire PAT solution, it does form the foundation for assembling the results of other quality measurement tools, such as Six Sigma, SPC, lean manufacturing and kanban.
Certainly some users are already using such tools, but they may not be integrated and optimized to give maximum real-time visibility of plant-floor information to the enterprise.
A successful PAT implementation requires volumes of data, often from disparate systems. Such a data exchange environment is exactly what S95 and B2MML are designed to provide.
All this sounds well and good, but you’ve heard such claims before. What is usually helpful is knowing how other companies are achieving success using integrated S88/S95 with B2MML solutions.
In 2003, Caracas, Venezuela-based food-and-beverage giant Empresas Polar reported it had successfully connected, in a few weeks time, its SAP PP-PI application to the plant floor using the S95 standard and B2MML schemas. At that time, project manager Francisco Ferrero said, “Our previous success using S88 provided us significant confidence to apply S95 and B2MML. Its clear, flexible, logical structure eliminated time-consuming discussions and allowed us to get to work.”
Arne Svendsen of Danish food giant Arla Foods says, “We view B2MML as the ‘wallbreaker’ for integrating complex, proprietary applications.”
Sandra Vann, of the Dow Co. in Midland, Mich., is a proponent of using S95 modelling to gather information that not only makes Six Sigma analysis better, but also reveals the right areas for additional study and improvements.
In accepting ISPE’s “Facility of the Year Award in Project Execution,” Oceanside, Calif.-based Genentech credited S88 and S95 as key elements that lead to its successful project.
Following a thorough investigation at its Oak Point operation in Belle Chasse, La., Chevron Chemical Co. is using production and batch management software and the S88 methodology to implement an MES to manage the full life cycle of production work orders, including manual, semi-automatic and automatic processes.
A very successful Make2Pack demonstration was hosted in 2006 by Proctor & Gamble in Cincinnati, Ohio. Following that demonstration, P&G representatives Dave Chappell, Rob Aleksa and Skip Holmes explained that P&G had been joined by SAB Miller, Unilever, Hershey and other end users to harmonize similar standards in order to produce a common framework of terminology and models that supports automation approaches and techniques from process to packaging.
Yep, on first blush it looks an awful lot like alphabet soup, but as the radio personality Paul Harvey so often said, “Now you know the rest of the story!” It’s not alphabet soup; it’s a carefully thought-out collection of standards and templates developed and assembled by some of the best minds in the control, automation and information disciplines with one central goal in mind: to improve your business’ visibility about what is happening right now on the plant floor.
Dave Harrold is co-founder of the AFAB Groups. He can be reached by email at firstname.lastname@example.org.
What? You want more?
For more information on the S88/S95 connection, see these articles from past issues of Control.
“Life’s a Batch,” Greg McMillan. June, 2005, p. 80.
“Full Throttle Batch and Startup Response,” Greg McMillan. May, 2006, p. 67.
“Still Life,” Greg McMillan & Stan Weiner, PE. October, 2006, p. 103.
“Mission Possible: Control and IT Integration,” Dave Harrold. October, 2006, p. 59.
“Connecting the Enterprise,” Rich Merritt. March 2006, p. 34.
“It’s More Than Batch!,” Maurice Wilkins, PhD. Web exclusive, November 29, 2004.
“The Business Value of Automation,” Rodger Jeffrey.
Software & Integration Whitepapers. Various authors