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By Jay LeCoque

Quality by Design and RMM: Helping Manufacturers Balance Quality and Speed to Market

Today’s drug development companies face a difficult challenge: balancing the need for product quality and safety while speeding time to market. Championed by the FDA, EMEA, and other global regulatory agencies, quality by design (QbD) represents a systematic approach to building quality into product and process design and development right from the start. QbD and rapid-detection RMM go hand-in-hand, because both share the same goals--to ensure a high-quality manufacturing process that is lean, efficient, and reliable.

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By William Dorner

Click here to download the Excel worksheet used in this article.

Many people use Microsoft Excel on a daily basis. Yet few people realize the extent of Excel's analytical capabilities. Fewer still put these capabilities to work for process improvement, product improvement and profit.Most Excel users are aware of the common formulas and charts. But with some creativity, users can produce tools like control charts, Pareto charts and box-and-whisker plots (see "Using Excel for Data Analysis," Quality Digest, October 1997). And with a little guidance, users can employ more advanced statistical methods with Excel. This article presents a how-to approach for one such advanced technique-Weibull analysis.

You haven't turned the page yet? Those of you who remain probably fall under one of two categories: those familiar with reliability data analysis, and Excel enthusiasts who are curious to learn one more way to exploit this versatile software. I predict readers in both groups will be glad they stuck around.

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By Roderick A. Munro, Ph.D

As more companies embrace Six Sigma, the need to hire and train employees in the methodology grows. One issue facing beleaguered managers and human resource departments is how to determine whether an applicant truly possesses the Six Sigma skills required by the company. If he or she has a certificate, does it have any value? If not, how does your organization verify employees' Six Sigma skills? Once you get beyond the marketing hype of Six Sigma, what will really help your organization eliminate or even prevent problems?

These questions and many more based on your particular needs should be addressed as you review what you and your organization will accept as qualified certification.

This article presents commentary on important items that apply to the value (or lack thereof) of Six Sigma certification in your organization.

Understand your needs

Whether you decide to grow your own Six Sigma practitioners or hire from the outside, management must understand the role that it wants Six Sigma to play in the organization. Just stating in a job posting that a person must be Six Sigma-certified is meaningless unless the organization knows what it really wants.

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By D. Z. Sokol and Robert Morris

The current economic downturn may have reduced a company’s business, but it has not reduced the requirements associated with doing business. This is particularly true for the numerous activities associated with technical data interpretation and application. For example, although the quantity of parts to be produced may be significantly less than last year, everything associated with the technical data package must still be addressed. This includes reviewing the constituent documents to determine accuracy and completeness, setting up first article inspections, generating manufacturing process plans, and so on.

In this period of reduced resources, there is even less margin for error. This means that those companies that get it right the first time have a distinct competitive advantage over those that can’t. The former are more productive, more cost-efficient, better able to meet schedules, and more valuable to their customers who are being whipsawed by rapidly changing economic conditions.

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By Quality Digest


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Of all the quality control methodologies over the years, one practice that has endured is statistical process control. Its staying power has much to do with the fact that SPC is based on the permanence of mathematics. SPC is one of the most logical and practical ways to monitor, control, and improve your processes.

There’s only one directory in this section, but it’s an important one—the SPC Software buyers guide. In this guide, you’ll find a list of companies that provide SPC software to help with data gathering, statistical analysis, problem-solving, design of experiments, real-time charting, root cause analysis, Pareto charts, hypothesis testing, and more. Each company’s offerings differ in functions, ease-of-use, format and add-on applications, so it’s best to contact them directly for more information and demonstrations.

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By R. Stephen Flynn

What Is Multisensor Metrology?

Multisensor metrology is dimensional measurement on a measuring machine that utilizes two or more different sensor technologies to acquire data points from features and surfaces of a part to perform more measurements than would be possible on a machine using a single sensor. Most multisensor machines are motorized and use software that repeats predetermined measurement sequences without the need for user interaction.

Most articles about measuring devices, instruments, or systems describe what they do and how they work. The manufacturers of these systems want readers to know about the innovation and technology that went into them. However, the missing part of such articles is how to use the measuring system to get the information that the user needs to make decisions. This article looks at multisensor metrology from a user’s perspective.

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By Anne Willimann



et’s travel back in time to September 10, 2008, at 10:28 a.m. At that moment, CERN became known to the general public when the first beam was successfully steered around the world’s most powerful particle accelerator—the Large Hadron Collider (LHC). This historic event marked the beginning of a new era of scientific discovery.

CERN is the European Organization for Nuclear Research, with headquarters in Geneva. Recognized as the world’s leading laboratory for particle physics, CERN is located 50 to 150 meters below ground under the city’s surroundings, and crosses the Swiss border with France. The LHC is installed in a tunnel 27 kilometers in circumference and provides collisions at the highest energy levels ever achieved in laboratory conditions. CERN physicists can observe these collisions via four huge detectors, exploring new territory in matter, energy, space, and time.

Particle Physics

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By Craig Cochran

The most significant change in the upcoming revision to ISO 9001 is probably not what you'd expect it to be: It's not customer satisfaction, continual improvement or even the process-model structure of the standard. The most significant change is the requirement for quality objectives. ISO 9001:2000 requires that quality objectives be established at each relevant function and level within the organization (i.e., just about everywhere). The manner in which quality objectives are established and managed will have an enormous impact on the organization's performance. The quality objectives will either drive strategic improvements throughout the organization, significantly elevating the importance of the quality management system, or they'll simply become a meaningless exercise in data collection. It all depends on how the task is carried out.

 The basic requirements for quality objectives are quite simple:

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Welcome to Quality Digest’s 2009 Gauges Buyers Guide, which features more than 140 manufacturers and distributors of gauges. Each listing contains the company’s address, telephone and fax numbers, and a web address (if provided). Many of these companies supplied a list of the types of gauges that they provide, selected from a predetermined list of 35 gauge types. Please refer to the abbreviations key for these types.

We encourage you to visit our online buyers guide database at www.qualitydigest.com/content/buyers-guides  for detailed descriptions of the gauge manufacturers’ and distributors’ products, if this information has been provided to us.

The products listed in this guide have been neither evaluated nor endorsed by Quality Digest . Only those companies that responded to our requests for information are listed. We hope this resource will help you find the right gauge for your specific needs.

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Incredible as it seems, Six Sigma is now more than 20 years old and still going strong. The methodology saves companies huge sums of money by redefining processes and reducing defects. Long a staple of quality improvement at manufacturing plants, Six Sigma is now penetrating into sectors such as health care, government agencies, service organizations, and many more. Increasingly, lean precepts such as eliminating waste and more efficiently organizing workspaces have become integrated with Six Sigma project. The result, lean Six Sigma, has become prevalent across industry.

This section contains the Six Sigma Services and Software buyers guide. This directory can help you implement, maintain, and improve your organization’s Six Sigma efforts. Embracing the Six Sigma path often leads to stunning improvement in a very short period of time—the companies found in the following pages can help you get there. Those with the acronym “SVC” following their listing offer Six Sigma services; those with a “SW” offer Six Sigma software. Many, you’ll note, offer both.