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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.
In its optimum form, Six Sigma is anything but simple or practical. Given its considerable upfront cost and ongoing complexity, it’s best viewed as a results-driven expedition of Homeric scope, one where the final destination is 3.4 defects per million opportunities. It’s not a journey for the faint-hearted. You must be seriously committed to pursuing it for the long term, or you’ll never recoup your sizable upfront investment, let alone enjoy a net return.
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.
Welcome to Quality Digest’s 2008 Flowchart/Process Simulation Software Directory. The companies in this buyers guide create or distribute software whose primary function is to aid in analyzing a company’s existing designs or operations to create important process-improvements and cost-savings opportunities. Functions include the flowchart, as in a schematic representation of a process used to help the user visualize the content or to find the flaws in the process; and process simulation, such as viewing a computer simulation that mimics a company’s operations to determine optimal conditions, bottlenecks, or sensitivity to process changes.
Included in this buyers guide are company names, addresses, telephone and fax numbers, and web addresses. Further information that has been provided to us, such as descriptions of the software modules/suites, is available online at www.qualitydigest.com/content/buyers-guides.
Quality improvement is a tough undertaking for even the savviest organization. There’s no need to go it alone, however. Quality system consultants and trainers can help keep you and your organization on the right path, and ensure that you’re current in your knowledge of best practices.
On the following pages, you’ll find our Consulting and Training buyers guide. This guide include hundreds of companies that employ experts in the Malcolm Baldrige National Quality Award program, statistical process control, Six Sigma, leadership training, quality system development, and certification, among others.
These directories are not meant to endorse or exclude any particular organization. Rather, they should be used as the starting point in the data-gathering process. Readers are encouraged to contact the companies directly for more information and to ask for—and check—references. Further information, including company descriptions (if provided to us) can be found on our web site at www.qualitydigest.com/content/buyers-guides.
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.
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.
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
Electronic records--theircreation, modification, maintenance, retrieval, and archiving--can create ongoing challenges for all organizations. For industries regulated by the U.S. Food and Drug Administration (FDA), such as pharmaceutical companies, medical device manufacturers, food processing plants, and biotech companies, the FDA’s Code of Federal Regulations Title 21 Part 11 applies to the specifications, use, and control of electronic records and electronic signatures.
The requirements of FDA 21 CFR Part 11 for electronic records are based on good practices, organization, and, most of all, common sense to ensure the efficient and secure handling of these records. In general, these requirements state that:
• All information is complete, and all records can be tracked to their originator and corresponding records.
• Appropriate securities are in place to ensure that tampering that would alter the record from its original intent does not take place.
• Only the appropriate parties can access the records, and only those so identified can create, modify, or review those records.
Welcome to Quality Digest's 2009 Six Sigma Services and Software buyers guide. This handy reference tool includes more than 200 companies that help you implement Six Sigma within your organization. Included in each description are the company name, location, phone and fax numbers, web site, and an acronym representing whether the organization offers Six Sigma services (SVC), software (SW), or both. Be sure to check this buyers guide online at www.qualitydigest.com/content/buyers-guides for additional information on these companies.
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 in your search for the right Six Sigma service or software provider to suit your needs.
