Lean, manufacturing

To minimize the cost of manufacture, one approach is to minimize the manufacturing throughput" time, sometimes called just in time or the Toyota lean manufacturing process. ... 

Effective collaboration among the core four PA disciplines analytical, chemometrics, process engineering and control automation along with other disciplines (e.g., pharmacist, chemist, analyst, product formulators, etc.) is imperative to realize effective PAT solutions that are consistent with the intended lean manufacturing or QbD objectives. 

Object / Component Oriented Requirements Analysis Program for Networked Lean Manufacturing by Paul G. Ranky 1992-2006... 

Ranky, P. G. (2003), Network simulation models of lean manufacturing systems in digital factories and an intranet server balancing algorithm, Int. J. CIM, 16(4-5), 267-282. 

The origins of lean manufacturing are often ascribed to the creation of the Toyota Production System (TPS) by the Toyota Motor Corporation. However, the history of lean manufacturing can be traced back to industrial developments which occurred more than 150 years before TPS. The foundation for modern manufacturing was laid by Eli Whitney in 1798 while Whitney is best known for his invention of the cotton gin, it is his invention of interchangeable parts and uniform production which revolutionized mass production (www.EliWhitney.org). 

Nearly a century later, Frederick W. Taylor introduced the concepts of time study and standardized work, coining the term scientific management. It was not until 1908, with Henry Ford s introduction of the Model T, that the value of lean manufacturing was recognized worldwide. Henry Ford is considered by some to be the first practi-... 

Furthermore, the effectiveness of lean manufacturing is limited by variability in the cycle time (C/T) for individual unit operations as well as by the finite risk of... 

Cogdill, R. P, Knight, T. P, Anderson, C. A., and Drennen, J. K. (2007), The financial returns on investments in process analytical technologies and lean manufacturing Benchmarks and case study,/. Pharm. Innov., 2(1-2), 38-50. 

Kozo Saito has a Ph.D. in mechanical engineering from Seikei University in Tokyo and is currently professor of mechanical engineering in the Department of Mechanical Engineering at the University of Kentucky. Dr. Saito s expertise and experience are in experimental combustion studies, thermal sensing and control, and lean manufacturing and control. He is a member of the Combustion Institute, the American Society for Engineering Education, and the American Society of Mechanical Engineers. 

Experience shows that adopting the principles of lean manufacturing from assembly industries can be a powerful operational improvement lever. Lean management, first introduced by Toyota, appeals because it holds out a promise no other approach can make not only does it cut costs and improve quality, but it also stabilizes operations and matches supply with demand. A companywide lean transformation program structured around the improvement of Overall Equipment Effectiveness (OEE) may unearth a hidden capacity that is equivalent to adding another plant to the manufacturing network. Lean, however, should not only be applied in production, but across the entire value chain. 

Other industries indicate one possible path for chemical companies going forward. If correctly implemented, the principles of lean manufacturing, developed first in the automotive and assembly industries and then used in process industries (such as chemicals, metals, pulp paper, and power) by companies like Alcoa, offer a promising approach. Major impact has been achieved by this method in large scale transformations over the last few years. In this chapter, we will focus on how to implement such a transformation rather than on the elements of lean manufacturing, since there are many publications on that subject. 

The ability to perform validation cost-effectively is dependent on an organization s understanding of requirements and its validation capability. This chapter applies the established Capability Maturity Model (CMM) to computer validation. Examples of validation metrics and measures are examined. The metrics cover prospective validation as well as operation and maintenance of computer systems. Lean Manufacturing and Six Sigma are promoted as tools that organizations can use to streamline and improve the performance of their validation processes. 

Most of the tools used in Lean Manufacturing can be implemented very quickly, and the results are soon evident. The following are among the most useful ones for the chemical industry... 

Fig. 12.2 Typical irr pact of lean manufacturing in the process sector ...

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