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By William Dorner

Professional statisticians typically have powerful software at their disposal to perform advanced analyses and create slick graphs. But many professionals in the quality field don't enjoy that luxury. Faced with a limited budget, they must be resourceful with the software they already have. Besides, not everyone needs the capability to perform nonlinear regression with custom loss functions for maximum likelihood! Fortunately, many occasional data analysts already own a versatile software capable of providing most basic quality analyses -- Microsoft Excel.

Skeptical? I don't blame you. The following examples show how to apply Excel for the graphical analysis of quality data. The examples range from somewhat obvious to downright clever. As it turns out, Excel's capabilities are limited only by your creativity.

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By Peter Marriott

In the field of medical products, devices, and components, regulatory requirements and customer expectations are demanding. Throughout the world, manufacturers and their suppliers are expected to comply with the highest standards and regulations.

ISO 13485--”Medical devices--Quality management systems--Requirements for regulatory purposes” is the standard for organizations engaged in the manufacture of medical devices. According to the most recent survey by the International Organization for Standardization ( www.iso.org/iso/survey2006.pdf ), there were a total of 8,175 current ISO 13485 registrations across 82 countries in 2006. Approximately 30 percent of all ISO 13485 registrations were issued in the United States, compared to only 6 to 7 percent of all ISO 9001 and ISO 14001 registrations. According to the survey, the 2006 total represents an increase of 3,110 (61%) compared to 2005, when there were 5,065 registrations across 67 countries and economies. Other major markets include Europe, Japan, Canada, Sweden, and Israel.

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By William H. Denney, Ph.D.

“We are going to win, and the industrial West is going to lose: There’s nothing much you can do about it because the reasons for your failure are within yourselves.”

--Konosuke Matsushita  

They work tirelessly to change our world irreversibly. If they succeed at what they’re doing and aren’t challenged, our way of life as we know it will end. While we whine about our bosses, our organizations, and our government; while we do the minimum that our jobs require; while we flip-flop through the mall and watch Oprah they’re planning, learning, and executing. When we’re tucked away in our beds, tossing and turning in restless sleep, they’re even busier. They don’t seem to tire; their passion is relentless. To them, weekends and holidays are inconsequential in their desire to have what we have.

We’re at war, but we seem oblivious to it. Our children’s future, our families, even our liberties are at risk, but for now, apathy is our primary defense. Secure in our ignorance of what’s happening far away, we think that we’re safe. But we’re not.

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By Jeffrey H. Eves and Tim Hack

The term “global” is ubiquitous in our daily lives. Like the economy, human rights, and peace, the environment is often discussed in global terms because that’s the only way to bring about profound change. Now, global warming--even though its full extent is unknown--has brought a sense of urgency to improving the environment.

The International Organization for Standardization (ISO) brings together stakeholders from around the globe to develop international standards that provide structured means to systematically manage improvement. ISO 14001--”Environmental Management Systems--Requirements,” along with a separate guidance document for its use, is the basic environmental management system ( EMS) standard being implemented globally to help manage environmental aspects of an organization. An EMS can be an effective tool in maintaining compliance with regulatory and other requirements, preventing pollution, and driving continuous improvement.

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By Ron Williams

Outside of their jobs, employees make important decisions every day. They vote on community issues. They help teach their children new skills. They purchase homes and cars and life insurance. But on the job, how many people are allowed to make important decisions about their work? How many people have input into how they do their own jobs, lead a team, find out what their customers need or make decisions about what will work better for their customers?

What are self-directed work teams?

Minnesota-based 3M is among an increasing number of companies that involve employees in the daily management of their business through work teams. These teams are empowered to take corrective actions to resolve day-to-day problems. They also have direct access to information that allows them to plan, control and improve their operations. In short, employees that comprise work teams manage themselves.

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By Dennis R. Arter

Three basic evaluation methods exist for any work activity: inspection, compliance auditing and management auditing. The first method, inspection, measures a process's output against certain characteristics. These characteristics, generally identified as form, fit and function, are specified, and the process output either possesses those characteristics or it doesn't. As a result, an inspection's outcome is always binary: pass or fail.

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By Hans Ericsson

We’re all aware of the importance of safety testing for medical products, both for implantable devices and external devices used to monitor or sustain us when we’re in the hospital. In the past, emphasis has been on the hardware-safety aspects of external medical equipment. Are they foolproof? Are there built-in safety mechanisms that prevent the device from causing harm through electrical shock or other forms of electrical or electronic malfunction?

Until a few years ago, little thought was given to the software that is an increasingly crucial part of these devices. Over time, however, the software that controls many electronic diagnostic and life-critical electronic equipment has grown in importance, to the point where a software failure could be just as catastrophic, and life threatening, as a hardware failure. A software crash on your laptop simply means a reboot. A software crash on a piece of equipment helping to keep a patient alive is another problem altogether.

Fortunately, the issue has not gone unnoticed. In 2006, the International Electrotechnical Commission (IEC) published IEC 62304--“Medical device software--Software life-cycle processes.”

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By Quality Digest

Welcome to Quality Digest’s 2008 ISO Standards Software Directory. The software that these companies create or distribute will help you to achieve or maintain registration to various quality standards of the International Organization for Standardization (ISO). The software products are designed to support the diverse needs of companies large and small, not only in compliance to standards, but in continuous improvement in areas of interest and industries such as: aerospace, analytical tools, benchmarking, consumer protection, corrective actions, customer satisfaction, data gathering, documentation management, energy, environmental issues, federal government agencies, going green, hazardous waste, health and safety, measurement process, process performance, return on investment, supply chains, value-adding methods, and more. If your needs concern any of these, take the time to contact these companies, and you may not need to look any further.

As with all of our directories, this guide is intended as a starting point to help readers choose the right solution for their needs. Quality Digest hasn’t evaluated, nor do we endorse, any of the products listed in this directory. Good luck finding the software solution to fit your needs.

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By Philip Hewitt

On-machine verification (OMV) is a recent innovation that combines existing technologies to solve more complex measurement problems on machine tools. Many machine tools are equipped with probing systems, and using the probe for simple part setting is an established process. Simple macro-based probing cycles allow the user to measure basic features such as faces, corners, and bosses, and these can be combined to create rudimentary inspection reports. These basic solutions are restricted to simple 2-D measurement because 3-D measurement is just not practical. Although skilled operators can sometimes adapt probing macros to measure along compound angles, this becomes too difficult and too time-consuming for complex, curved surfaces.

OMV solves these problems using graphical 3-D software methods to program the measuring sequences. The programming and reporting tools from inspection software are combined with machine tool post-processor expertise to create a measuring solution for machine tools.

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By Geraldine S. Cheok, Alan M. Lytle, and Kamel S. Saidi, Ph.D.

3-D Imaging Terminology

One of the documents to come out of committee E57 was E2544-08 -- "Standard terminology for three- dimensional (3-D) imaging systems." What follows is an excerpt from the document of some of the 3-D imaging terminology. To keep the excerpt short, we have included the definition of just a few of the terms listed.

3.2 Definitions of terms specific to this standard

3-D imaging system--a noncontact measurement instrument used to produce a 3-D representation (e.g., a point cloud) of an object or a site.

 

Angular increment--the angle between samples, Da, where Da = ai- ai-1, in either the azimuth or elevation directions (or a combination of both) with respect to the instrument’s internal frame of reference