When the job can be done consistently, then improvement can be made. The scientific methodology is the driving force to quality. The challenge is the need to implement FDA's risk approach.
Process analytical Technology (PAT) is a scientific risk-based framework to help pharmaceutical companies design, develop, and implement new efficient tools for use during product manufacture and quality assurance while maintaining or improving the current level of product quality assurance (FDA). PAT consists of two general components: 1) a set of scientific principles and tools supporting innovation and 2) a new regulatory strategy for accommodating innovation. It includes the PAT team approach. The primary focus of scientific manufacturing is to find new ways to use knowledge acquired during the processes and risk-based decisions. It is important for all team members to fully understand the processes and how they work.

With the team approach, work is standardized so each one knows their…...

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Bibliography

FDA. Pharmaceutical cGMPS for the 21st century -- a Risk-Based Approach: Second Progress Report and Implementation Plan. 17 Aug 2009. Article. 14 May 2013.

Green, a. & O'Rourke, D. "Lean Manufacturing practise in a cGMP environment." Pharmaceutical Technology Europe, Vol 18 Issue 10 (Oct 1, 2006). Article.

Hunt, J. The "Just-in-Time" Method. 2013. Article. 11 May 2013.

Lean Production: A jaguar case study. n.d. Article. 11 May 2013.

Lean Manufacturing/Lean Service
Lean manufacturing and lean service are business techniques that can provide benefits and advantages to both the business owners and their customers. With lean manufacturing and lean service, a business does not only eliminate the unnecessary elements in doing business but similar assures the quality of the products and services that they deliver to customers and clients. There are several elements that compose lean manufacturing and service. From Lean Master Consulting, the following are some of the most important elements.

Elimination of Waste - eliminate those that are not important

Equipment Reliability - steadfast equipments when needed for operation

Process Capability - efficient process from development to production to delivery

Continuous Flow

Error Proofing - checking the quality of products and services before delivery

Stop the Line Quality System - when bad quality has been found, immediately stop the production

Standard Work - an organized system or process flow that serves as a guide to…...

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Bibliography

Basic Elements of Lean Manufacturing.

Retrieved on May 24, 2005, from the Internet.

Web site: http://www.leanmasters.com/elements.html

Kincaid, W. Lean Manufacturing: Unexpected Benefits for Accident Prevention.

Lean Manufacturing
Lean production is often seen as a panacea for all levels of production complexity, from the relatively simple assemble-to-stock to the very complex engineering-to-order workflows. The greater percentage of a given product that is specifically tailored to a customers' unique requirements, the higher the level of greater the contribution of lean manufacturing to overall cost reduction (Hallgren, Olhager, 2009). It has often been said in research that the universality of the lean production concept is a chimera and enterprises must make choices as to the best possible production system for their specific strategic business requirements (Cooney, 2002). This is true with the caveat that the greater the level of customization of a given product and the need to ensure a high level of agility in the sourcing, supply chain and production process, the greater the need for a uniquely defined lean manufacturing system (Shetty, Ali, Cummings, 2010).

Analysis of Lean…...

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References

Chen, H., Lindeke, R.R. & Wyrick, D.A. 2010, "Lean automated manufacturing: avoiding the pitfalls to embrace the opportunities," Assembly Automation, vol. 30, no. 2, pp. 117-123.

Cooney, R. 2002, "Is "lean" a universal production system? Batch production in the automotive industry," International Journal of Operations & Production Management, vol. 22, no. 9, pp. 1130-1147.

Doolen, T.L., Nagarajan, R.D. & Hacker, M.E. 2002, "Lean Manufacturing: An Electronics Manufacturing Perspective," IIE Annual Conference.Proceedings,, pp. 1-7.

Hallgren, M. & Olhager, J. 2009, "Lean and agile manufacturing: external and internal drivers and performance outcomes," International Journal of Operations & Production Management, vol. 29, no. 10, pp. 976-999.

The lack of manufacturing integration to this process was responsible for $60 of the $200 per order processing cost.
Figure 1: Typical order Workflow

Solution

Business Process Management analysis showed that there were several iterations of documents at the initial customer design sessions, and each iteration had slightly different input for the manufacturing orders. The analysis of this area through lean manufacturing BPM techniques also showed that by using more of a knowledge management system than just a simple Microsoft Excel database to capture customer requests, the expertise in the company could be better applied to the unique orders. Six Sigma analysis of these initial phases of an order showed that the company was not using any of the accumulated expertise or knowledge it had gained over decades of work in the product area they specialized in, which is heating and cooling equipment.

Using BPM-based workflow tools and techniques the company also was…...

Lean Manufacturing and JIT
JIT

Evaluate three of the main elements of both lean thinking and JIT. How can these concepts be used for effective planning and control of an operation? How are these two concepts different? How can the differences in each concept be overcome to achieve maximum efficiency benefits of both lean thinking/JIT systems?

Lean thinking was introduced to improve the traditional 'batch-and-queue' manufacturing process. One of the core principles of lean manufacturing is that of 'one-piece flow,' a system that "rearranges production activities in a way that processing steps of different types are conducted immediately adjacent to each other in a continuous flow" (Lean thinking and methods, 2012, EPA). This is designed to eliminate wasteful movements of workers and compress the time required to produce each, individual component of the manufactured product. Lean thinking strives to maximize efficiency of both time and resources. Lean thinking is also a zero-defect philosophy.…...

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References

Lean thinking and methods. (2012). EPA. Retrieved:

 http://www.epa.gov/lean/environment/methods/ 

Lean thinking and JIT Operations. (n.d). PowerPoint. Retrieved:

rubybuccat.wikispaces.com/.../view/Lean+Thinking+and+JIT.ppt

These measures of performance vary significantly across manufacturers, yet lean manufacturing initiatives share a common basis in core areas of measurement. These common areas of measurement to evaluate the performance of lean manufacturing initiatives include company-specific, Sales, Quote and Order, Customer Service, and Warranty & eturns (Hallgren, Olhager, 978, 979). Depending on the intersection of lean manufacturing process and level of product customization as defined by to-order strategy a subset of the metrics shown in Table 3: Comparison of Lean Manufacturing Metrics and Performance are often used.
Table 3: Comparison of Lean Manufacturing Metrics and Performance

Areas of Measurement

Baseline: What is Measured

esulting Performance

Company-specific

Project costs and expenses

Use as a baseline for defining OI

Number of orders per year

Determine configuration's impact on inventory turns

Current inventory and costs

Inventory turn savings

Customer Data

Lifetime cost per customer; avg. deal size by customer

Sales

Order cycle time

Order cycle times reduction of 37% or more recorded with mftrs contacted

Cost of Sales

Days Sales…...

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References

Cavusoglu, Hasan, Huseyin Cavusoglu, and Srinivasan Raghunathan. "Selecting a Customization Strategy Under Competition: Mass Customization, Targeted Mass Customization, and Product Proliferation." IEEE Transactions on Engineering Management 54.1 (2007): 12-28.

Grewal, Chandandeep. "An initiative to implement lean manufacturing using value stream mapping in a small company." International Journal of Manufacturing Technology & Management 15.3/4 (2008): 404-417.

Hallgren, Mattias, and Jan Olhager. "Lean and agile manufacturing: external and internal drivers and performance outcomes." International Journal of Operations & Production Management 29.10 (2009): 976-999.

Kumar, Sameer, and Sarah Craig. "Dell, Inc.'s closed loop supply chain for computer assembly plants." Information Knowledge Systems Management 6.3 (2007): 197-214.

this therefore means that it is important to first clarify the different perspectives represented herein for example creation of multilevel framework including the analysis of well-established literature that is related to this discussion .
Womack, Jones and oos (1990) in their canonical work The Machine that Changed the World were the first ones to formally introduce Lean Product Development. Although they mainly focused on manufacturing and assembly processes, they still describe some tools and methods that are used to achieve Lean performance in Product Development including Concurrent Engineering. Consequently it should be noted that there is a strong connection between Lean Product Development and Concurrent Engineering.

Concurrent Engineering has been defined by Winners et al. (1998) as the systematic approach that integrates the concurrent designs of the different products in relation to their manufacturing and supporting processes with the intention to cause developers of these products to consider all the elements…...

Wiremold's Success With Lean Manufacturing
Evaluating Wiremold's Success with Lean Manufacturing

Wiremold successfully transformed itself from highly inefficient production and manufacturing processes that had centered on batch-and-queue methods of scheduling to be one of the acknowledged global leaders in lean manufacturing. So great were there accomplishments that they were mentioned in the book Lean Thinking and have consistently been used as a case study of how the adoption of lean manufacturing frameworks and principles can transform the financial performance of a company (Fiume, 2004). Previously to implementing lean initiatives, the company earned $100M in revenues and had an enterprise value of $30M. Within just ten years of operating with lean manufacturing processes in place the company had revenues grow to $450M and a value of $770M, which is the price the company was sold at in that year. For a transformation to be this successful and pervasive, a cultural shift is involved…...

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Nauhria, Y., Wadhwa, S. & Pandey, S. 2009, "ERP Enabled Lean Six Sigma: A Holistic Approach for Competitive Manufacturing," Global Journal of Flexible Systems Management, vol. 10, no. 3, pp. 35-43.

Saurin, T.A., Marodin, G.A. & Ribeiro, J.L.D. 2011, "A framework for assessing the use of lean production practices in manufacturing cells," International Journal of Production Research, vol. 49, no. 11, pp. 3211.

Shetty, D., Ali, A. & Cummings, R. 2010, "Assess Lean Model for Thinking Manufacturing Initiatives," IIE Annual Conference.Proceedings,, pp. 1-6.

Chipotle: Lean Manufacturing
Applying lean manufacturing to the food industry

Even though the food industry faces certain unique challenges regarding manufacturing (such as maintaining appropriate sanitary measures), there are many similarities between it and other industries

Particularly in the fast food industry, where foods are 'assembled' at point-of-purchase with standardized materials the concepts of lean manufacturing can be applied

isk of applying lean in food industry, lean culture

Traditionally, it has been assumed that the food industry did not lend itself to lean manufacturing principles

"Typically these business types sell their product from large distribution or product mixing centers, and are not make-to-order businesses" (Heymans 1).

Fast food companies "manufacture to a forecast, and usually the forecast lead time to production is long, resulting in large differences between the forecast that drives production levels, and actual demand" (Heymans 1).

However, "companies in this industry have the same cost, quality and delivery pressures as any other type of business"…...

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References

Heymans, B. Lean manufacturing in the food industry. Retrieved from:

 http://www.flowmakers.com/articles/Articlefoodindustryandkaizen.pdf

classical examples of some of the consequences that globalization has for some American companies. Indicated as one of Orleans's best supplier of different parts and accessories, used in the construction of elevators, Customs Fabricators Inc. faces the cheaper competition from Mexico. Orleans has decided to reduce its production costs and has organized an auction, where suppliers from Mexico are seen as favorites, due to their low costs. On the other hand, one of Customs's main advantages was its presence next to the Bedford plant, where some of the parts it used were produced. If a company from Mexico would be chosen, then there would be no legitimate reason for Orleans not to move the entire production facility to Mexico.
Ben's company crates value by supplying Orleans with parts and accessories. The distinct specialization of Ben's company ensures that the accessories and parts produced respond to the exact requirements from Orleans.

Customs…...

Though there are an increasing number of manufacturers who are successful in implementing lean principles to the factory floor, using them to the rest of the organization has a long way to go. (Moving lean beyond the factory floor)
To conclude, History has established that Lean Manufacturing is here to settle. The query is, "Will your company adopt Lean Manufacturing and make it an enduring company strategy and eventually a way of life?" The answer to this query will decide whether the company will endure in the ever more aggressive manufacturing environment that we live in. (Timco, 2001)

eferences

Becker, onald M. (June, 2001) "Lean Manufacturing and the Toyota Production System" Automotive Manufacturing and Production. pp: 12-16

Chaneski, Wayne S. (February, 2001) "Companies Starting to Think About Lean Manufacturing" Modern machine Shop. pp: 10-15

Clarke, J. (14 July, 2004) "Lean's Benefits are Clear, but Many Manufacturers are Significantly Behind their Vision for Lean, says…...

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References

Becker, Ronald M. (June, 2001) "Lean Manufacturing and the Toyota Production System" Automotive Manufacturing and Production. pp: 12-16

Chaneski, Wayne S. (February, 2001) "Companies Starting to Think About Lean Manufacturing" Modern machine Shop. pp: 10-15

Clarke, J. (14 July, 2004) "Lean's Benefits are Clear, but Many Manufacturers are Significantly Behind their Vision for Lean, says Aberdeen Group Report" Business Wire. pp: 5-11

Harbour, Ron. (December, 2001) "Leaders are responsible for lean - Opinion & Analysis: Manufacturing" Automotive Industries. pp: 17-20

In chasing the cost reductions made possible with manufacturing offshore many companies open themselves up to precisely the challenges of illustrated in the Napoli case study. The effects of lean production on new initiatives are that it actually stops the cultural integrative aspects of companies in new nations and regions.
Summary

Lean production is a mirage as it states that more can be done with less. The many benefits of lean production come at the expense of longer, more monitored and more stressful hours on workers, and a myopic approach to measuring results. Lean production is often called the elimination of both wasted processes and products from a manufacturing strategy, yet the truth is that lean production is another word for cost reduction in many companies. The need for using an accelerated process management technique, where entire series of business areas are revamped provides an illusion of progress when it fact…...

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References

Alstyne, Marshall van, Erik Brynjolfsson, and Stuart Madnick. "The Matrix of Change: A Tool for Business Process Reengineering." MIT Sloan School Working Papers available on the Internet, accessed on April 2, 2007:

 http://ccs.mit.edu/papers/CCSWP189/ccswp189.html 

Alstyne, Marshall van, Erik Brynjolfsson, and Stuart Madnick "Why Not One Big Database? Principles for Data Ownership." Decision Support Systems 15.4 (1995): 267-284.

Porter, Micheal. The Competitive Advantage of Nations. The Free Press. Boston, MA, 1998.

..The carts have had a big impact on our setup process. Machine downtime during setup has been reduced by more than 50%. Product quality has improved; we have been able to reduce lot sizes by 50%; and operators can set up machines instead of searching for hardware, tools and documents. As we reduced lot sizes, other opportunities for improvement surfaced. e found it was better to have the material supplier precut the barstock. e now manage precut inventory with a two-bin pull system and an electronic replenishment signal delivered to the material supplier. This has increased inventory turns, reduced manufacturing order pick time from over 3 hours to less than 5 minutes and reduced floor space by over 50%." (Chaneski, 2006, italics mine)
In this example, a quantifiable reduction in time was achieved, with a corresponding improvement in quality, because operators were better able to implement the necessary steps in assembling…...

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Works Cited

Chaneski, Wayne. (2006) "Company implements lean strategies." MMS Online. Retrieved 16 Aug 2006 at  http://www.mmsonline.com/articles/0103ci.html

" In those manufacturers who are attaining lean enterprise-level performance, the cultures of their companies have become incredibly focused on metrics, and in fact the organizations themselves have become so metrically driven that the culture itself embraces the concept of measuring performance and improvement (Nash, Poling 2007).
Lean positioned for cost cutting vs. customer-driven change. This is also a critical mistake many manufacturers make, and often becomes the main focus these companies continue to pursue, as opportunities to better integrate their strategies with customers, suppliers, buyers, and service organizations present themselves.

Evolution of the Lean Enterprise

Manufacturers have continually struggled to gain the advantages of lean manufacturing, starting first with manufacturing processes at the shop floor level and progressing to a vision of implementing an entire lean enterprise. What's become essential in the pursuit of the lean enterprise are the creation of strategies for driving waste of all types (time, logistics, costs) out…...

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References

Aberdeen Group (2005). Best Practices in Strategic Service Management. Aberdeen Group Report. June, 2005. Boston, MA. Executive Summary. Retrieved January 26, 2008.

Aberdeen Group (2006). Best Practices in International Logistics. Aberdeen Group Research Report, January, 2006. Boston, MA.

Retrieved January 31, 2008

Adamides, N Karacapilidis, H Pylarinou, D Koumanakos. (2008). Supporting collaboration in the development and management of lean supply networks. Production Planning & Control, 19(1), 35. Retrieved January 31, 2008, from ABI/INFORM Global database. (Document ID: 1423331461).

Some also wonder where the six sigma term that is used so often in lean manufacturing came from. The sigma is a Greek letter which is used to represent the standard deviation of a targeted population (Gupta, 2003). The six sigma term therefore comes from the idea that, if one has six standard deviations that come between the mean result of any process and the nearest limit for specification, than one will create virtually no items that actually exceed those specifications (Gupta, 2003). This idea is the main basis for what is called the process capability study, which is generally used by quality professionals, and the six sigma term has roots within that particular tool.
In summary, all management theories are very important when it comes to what is appropriate for businesses (Achanga, et al., 2006). The theory of constraints is discussed first because it is the theory that goes…...

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Bibliography

Achanga, Pius, Shehab, Esam, Roy, Rajkumar, & Nelder, Geoff. (2006). Critical success factors for lean implementation within SMEs. Journal of Manufacturing Technology Management, 17(4).

Cusumano, Michael a. (1998). Thinking beyond lean: How multi-project management is transforming product development at Toyota and other companies. London: Free Press.

Emiliani, M.L. (2000). Supporting small businesses in their transition to lean production. Supply Chain Management: An International Journal, 5(2).

Gupta, Praveen. (2003). Six Sigma Business Scorecard. McGraw-Hill Professional.

Principles of Business Essay Topics

Ethics and Social Responsibility

The Importance of Ethical Decision-Making in Business
Sustainability and Corporate Social Responsibility: Balancing Profits and Planetary Health
The Role of Business in Addressing Social Issues
Whistleblower Protection and the Ethical Obligations of Employees

Innovation and Entrepreneurship

The Role of Innovation in Driving Business Growth
The Entrepreneurial Mindset: Characteristics and Erfolgsfaktoren
Creating an Innovative Work Environment
The Impact of Technology on Business Innovation

Leadership and Management

Effective Leadership Styles: Authoritarian, Democratic, and Laissez-faire
Motivating Employees: Theories and Best Practices
The Importance of Diversity and Inclusion in Management
Managing Organizational Change: Challenges and....

Process of Analysis:

1. Problem Definition: Identified the core problem as the decline in market share and profits for the electronics company.

2. Data Collection: Gathered data from financial statements, sales reports, market research, and competitive analysis.

3. Hypothesis Generation: Formulated hypotheses related to factors contributing to the decline, such as product innovation, marketing effectiveness, and operational efficiency.

4. Data Analysis: Performed statistical analysis (regression, correlation) to test the hypotheses and identify significant factors.

5. Root Cause Identification: Used causal mapping and decision trees to determine the underlying causes of the decline.

6. Insights Generation: Developed recommendations and actionable strategies based on the insights gained from....

Lean Procurement Principles for Streamlining Processes and Reducing Waste

Introduction

In today's increasingly competitive business landscape, organizations are striving to optimize their operations and reduce inefficiencies. Lean procurement, based on the principles of the Lean manufacturing philosophy, offers a powerful framework for streamlining purchasing processes and eliminating waste. By implementing Lean procurement principles, organizations can achieve significant cost savings, improve delivery performance, and enhance overall supply chain efficiency.

Key Lean Procurement Principles

1. Value-Based Purchasing:
Identify and focus on purchasing activities that add value to the organization and customer. Eliminate non-value-added activities and processes.

2. Supplier Partnerships:
Establish strategic partnerships with suppliers who align with the organization's....