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Back to the Future
by Ronald D. Snee and Jason J. Kamm
(published in Quality Progress, December 2007)
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Analyzing process data has long played a significant role in problem solving, troubleshooting and improvement. Sometimes we take this analysis for granted.
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Biosimilars and the Changing Environment of Regulation and Reimbursement
by Carmen Medina and Conrad J. Heilman
(published in BioProcess International, October 2007)
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The science of ecology long ago taught us that to fully understand the likely fate of an organism, it must be seen in the context of the laws of its larger environment. So it is with biosimilar products. To fully understand the therapeutic and commercial prospects of biosimilars, you must view them in the context of a rapidly evolving environment of industry and public opinion, current regulatory developments, pending legislation, and reimbursement realities that envelops all FDA-regulated medical products.
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Use DMAIC to Make Improvement Part of 'The Way We Work'
by Ronald D. Snee
(published on www.asq.org, September 2007)
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Faster, better, cheaper. That’s what organizations across almost all major industries must now do to remain competitive. Sometimes these goals might seem at odds with each other – for example, better versus cheaper – but meeting these goals is a must.
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Setting Pharma Firms Straight with Tunnell Vision
by Adam Stone
(published in Philadelphia Business Journal, Aug 31, 2007)
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Sometimes you need a smaller window to see the bigger picture. Rather than continuing to go broad, Tunnell Consulting started going deep, honing in on the life sciences sector, when Joe Tempio became CEO in 2005. It’s like in an orchestra. It’s not just a brass instrument that you need. "It’s a tuba, and you need a guy who can play the tuba."
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Pandemic Influenza: Companies Should Plan for the Worst and Assess Legal Exposure
by Margaret C. "Peggy" Binzer and Ted Shoneck
(published in Update, July/August 2007)
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Pandemic flu differs from any other threat to business continuity as it has the potential to impact communities around the world at the same time, disrupt trade and result in increased liability. There is more than one reason to do continuity of operations planning . . . In addition to the business operations risks consider the legal risks.
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Methods for Business Improvement — A Holistic Approach
by Ronald D. Snee
(published in ASQ Statistics Division Special Publication, 2007)
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This article looks at current trends in the development and use of business improvement methodology. Iti is conjectured that the next generation of improvement methodology will integrate the best aspects of currently used approaches such as Lean manufacturing, Six Sigma, ISO 9000 and Baldrige assessment thereby streamlining the improvement methodology and increasing the effectiveness and efficiency of the approach.
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Integrating Lean and Six Sigma — A Holistic Approach
by Ronald D. Snee and Roger W. Hoerl
(published in ASQ Six Sigma Forum Magazine, May 2007)
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Comprehensive improvement requires both lean – to achieve simplicity-and Six Sigma-to manage complexity. Based on our more than 60 years of collective experience with improvement methods and programs with leading companies, we believe organizations that successfully pursue lean Six Sigma will do so by: • Taking a holistic view of the business and of business improvement. • Adopting a holistic improvement method. • Establishing an integrated project management system. Guided by those three simple but powerful principles, ambitious organizations can begin to reach the full potential of lean Six Sigma.
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Can You Win the Space Race?
by Jason Kamm
(published in Pharmaceutical Manufacturing, May 2007)
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Quality by Design demands a clear understanding of the design space. Are you ready? Complying with ICH Q8 requires knowledge of three key spaces: design, technology and regulatory. Here’s how one company used Design of Experiments to trouble-shoot variability in the validation of a controlled-release pain reliever.
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10 Steps to Process Improvement
by Ronald D. Snee
(published in Pharmaceutical Manufacturing, January 2007)
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Many mid-lever pharmaceutical manufacturing professionals recognize the competitive threats and pressures that beset their companies - competition from abroad and from generics, pressure to reduce costs and a dearth of blockbuster product in the pipeline - and they want to do something about it by improving manufacturing processes. They recognize, too, that their current approaches to improvement aren't getting the job done. But they hesitate to take the initiative. The use of approaches such as Lean Manufacturing, Six Sigma or a combination of the two seems daunting. Moreover, executives have been convinced that only top-down improvement initiatives, spearheaded by top management, stand any real chance of success
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The Hard Part: Holding Improvement Gains
by Ronald D. Snee
(published in Quality Progress Magazine, September 2006)
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In organizations of all kinds, whether they practice Six Sigma, lean, Malcolm Baldrige National Quality Award criteria, total quality management or some other improvement methodology, sustaining improvement gains proves to be far more difficult than many think. In this article, award-winning Six Sigma expert Ron Snee explains that the time to focus on sustaining the gains is during the initial stages of implementation, not after improvement has been achieved.
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Implementing a Strategic PAT Program
by Ray Schneider
(published in PAT Insider Magazine, July 2006)
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The most effective PAT programs begin by putting PAT in a strategic context, including an appreciation of the value it can generate and a prioritization of the products and processes to which PAT can be applied to realize that value. Nevertheless, few companies launch their PAT initiatives in this organized and logical fashion. In this article, Tunnell Chief Consulting Officer and Vice President Ray Schneider explains that an effective PAT program is far more than applying the right on-line technology like NIR. Instead, PAT offers companies a real opportunity to achieve systematic improvement in manufacturability that generates significant business benefits.
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Aligning PAT, Validation, and Post-Validation Process Improvement
by Ray Schneider, George Huhn, and Philippe Cini
(published in PAT Insider Magazine, April, 2006)
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The FDA has put the pharmaceutical industry on notice that its manufacturing techniques are often way below those of less harmful consumer products like laundry soap. So said former FDA PAT initiative leader Ajaz Hussain when referring to the current state of pharmaceutical manufacturing in America. In this article,Tunnell consultants Schneider, Huhn and Cini pool their knowledge and resources to explain the pitfalls of common pharmaceutical manufacturing practices, what has to change to fully satisfy government demands, and the benefits drug makes can realize in consumer trust and operating performance by finally learning true process understanding for marketed and in-development products.
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What Can Improve Six Sigma's Effectiveness?
by Ronald D. Snee
(published in Six Sigma Forum, February, 2006)
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Six Sigma is arguably the best improvement strategy and methodology available today. But when we recognize improvement methodologies have been evolving over the last 100 years or so, we see the need to continue to focus on making Six Sigma even more effective.
In this guest editorial, leading Six Sigma expert Ron Snee explains the five improvements necessary to achieve this goal.
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A Systematic Approach to Deviation Reduction Through Six Sigma
by Thomas L. McGurk and Ronald D. Snee
(published in Pharmaceutical Technology, October, 2005)
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Managing deviations in pharmaceutical manufacturing processes is one of the highest priorities for any drug maker, yet companies vary significantly in that capability. In this article, Tunnell Consultants McGurk and Snee explain how Six Sigma methodology provides the strategy, methods and tools to create a systematic approach to deviation reduction, and thus dramatically increase the probability of finding root causes, make corrections more sustainable, and improve the execution of corrective work.
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PAT: It’s All About Value
by Ray Schneider and Philippe Cini, Ph.D.
(published in PAT Insider Magazine, Sept. 2005)
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Since the inception of the FDA’s PAT initiative, discussions of its implications have focused largely on the application of on-line instrumentation. But a technology-first approach to PAT misses the real point: business value. In this article, Tunnell Vice President/Chief Consulting Officer Ray Schneider and Tunnell PAT Program leader Philippe Cini explain the key principals to developing a PAT program that truly increases value by improving quality, consistency, throughput and speed to market.
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When Worlds Collide: Lean and Six Sigma
by Ronald D. Snee
(published in Quality Progress, Sept. 2005)
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Facing unprecedented pressure to improve performance across the board, organizations cannot afford to forego the benefits of either Six Sigma or lean. But proponents of differing performance improvement methodologies sometimes look like members of warring religions. Who is right? In this article, Tunnell's Ron Snee, winner of numerous top quality awards, explains that it's not a combination of both that is needed, but an overall approach to holistic improvement that will give companies the benefits they want.
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Pharmaceutical Cleaning: A Comprehensive Approach
by David LaTart
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Now that the FDA has decided to conduct inspections according to quality systems, it seems only prudent for pharmaceutical operations to re-evaluate their cleaning system and its policies and procedures. Cleaning seems simple enough; however, upon closer examination, the system of cleaning is complex and inter-related with several other functions in various areas.
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The Push for Modern Manufacturing
by Philippe Cini and Raymond E. Schneider
(published in Pharmaceutical Executive, March, 2004)
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The FDA's Process Analytical Technology (PAT) initiative is now giving pharmaceutical firms an incentive to become state-of-the-art and upgrade antiquated manufacturing processes that are costing the industry money -- inflating production costs by as much as 10% by some estimates. To meet the call for modern manufacturing in the pharmaceutical industry, Tunnell Consulting has developed an innovative PAT framework that includes five key elements and that emphasizes a long-term strategic vision that ensures sustainability for years to come. It's an approach that ultimately transforms a company in terms of cost, compliance and safety.
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Ramping Up and Ensuring Supply Capability for Biopharmaceuticals
by Thomas L. McGurk
(published in BioPharm International, January 2004)
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Stock outages of pharmaceutical and biological products occur with disappointing regularity. One major pharmaceutical company -- faced with supply issues for two of its biopharmaceutical products, one of them destined to become a blockbuster -- decided to take systematic action to ensure reliability and meet enormous market demands. Tunnell Consulting took the challenge to help this firm adopt a comprehensive approach to operational and organizational improvement to effect maximum change. Results: Capacity increased by more than 100% for one product, and by more than 50% for the other.
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Eight Essential (Six Sigma) Tools
by Ronald D. Snee
(published in Quality Progress, December, 2003)
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The broad use of Six Sigma has taught us much about how to make the best use of Six Sigma tools. Now, according to expert Snee, we need to take a look back and reflect on what we've learned, particularly those things that make these tools more effective, so that we don't make future mistakes. Snee says we would do well to pay attention to what philosopher George Santayana said, "Those who remain ignorant of history are doomed to repeat it."
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The Six Sigma Sweep
by Ronald D. Snee
(published in Quality Progress, September, 2003)
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As organizations implement Six Sigma over time, they eventually begin to look for ways to weave Six Sigma into all aspects of business, taking it beyond process improvement. Six Sigma thus becomes part of your mind-set and becomes your organization's defining characteristic, its signature. In this article, Snee explains how this signature can help your company achieve competitive advantage.
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Six Sigma: Develop Useful Models
by Ronald D. Snee
(published in Quality Progress, December, 2002)
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The widespread use of Six Sigma has renewed interest in developing statistical models and using regression analysis. In this article, Snee explains that it is important to use a combination of discovery and testing theories to identify the critical few process variables and validate the resulting model. Finding the critical few variables allows you to better control and optimize a process.
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Six Sigma Project Selection Process
by Ronald D. Snee and William F. Rodebaugh, Jr.
(published in Quality Progress, September, 2002)
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A lot of dicussion about project selection is happening in companies deploying Six Sigma. In fact, the authors note that many companies believe project selection is the most difficult element of Six Sigma deployment. In this article, the authors discuss the keys to mature project selection, and the creation of an overall organizational improvement system.
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Focus on Improvement, Not Training: How Six Sigma Can Do It Right
by Ronald D. Snee
(published in Quality Management Forum, Spring, 2001)
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Few people will argue against the value and importance of training. Yet, in practice, training does not get the respect, support and involvement of management that many feel it should. It is argued here that the reason for this behavior is that training is often focused on training per se, and not on helping the organization improve in a real and measurable way. It is becoming more widely recognized that a clear, measurable business benefit should be the goal of every training event. Six Sigma and its associated training has this characteristic. In this article, Six Sigma is used to illustrate this alternate way to think about, design, and deliver training that will be seen by management as essential to the success of the organization.
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Dealing with the Achilles Heel of Six Sigma Initiatives: Project Selection is Key to Success
by Ronald D. Snee
(published in Quality Progress, March 2001)
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Many practitioners of Six Sigma have found that project selection is the most difficult aspect of deploying Six Sigma. One quickly learns that if projects are not selected properly the Six Sigma initiative can be at risk. Projects don't deliver the expected bottom line results, the organization becomes frustrated with the effort and, slowly but surely, attention and resources are focused on other initiatives. There are many dimensions to successful Six Sigma projects including proper project scope, assignment of the right Champion, Black Belt or Green Belt, completion in a timely fashion (3-6 months), support and involvement in the project by a variety of functions, and management review to keep the projects focused and on schedule. Each of the aspects of a successful project is discussed and illustrated with examples.
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Impact of Six Sigma on Quality Engineering
by Ronald D. Snee
(published in Quality Engineering, 12, No.3, 2000)
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Several key questions regarding Six Sigma are addressed. The discussion includes what's new and different, Six Sigma's importance and value, why it works, roles, and research needs. It is argued that Six Sigma is different, it works because of unique characteristics, and requires change on the part of everyone it touches. Specifically, Snee notes that for quality engineers and other quality professionals to be successful in this new environment, they must develop new skills including leadership and other soft skills, business acumen, and an understanding of both the management and technical issues involved. The need for those impacted to shift emphasis to more strategic issues is also discussed.
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