When I started at General Motors (GM) in the 1960s, we were the biggest and best company in the United States and most of the world. As a matter of fact, I believe that only a couple of state industries in Russia surpassed the number of people that GM employed. Many of us, observing the poor quality of work done in the factories as we first entered them, found it hard to believe that GM could be so good. One of my friends and colleagues, Mark Horvath, captured the situation insightfully: "We [GM] can depend on the stupidity of our competition."

As time went on and we became more a part of the GM culture, we began to think of Mark’s observation in a different way. We began to unconsciously believe that the reason we were so large, powerful, and successful was that we really were smart. As a matter of fact, in those days, one of the criteria we used for making decisions was "Will this enhance our market position so much that the antitrust guys will try to break us up?" We thought we had to be careful not to be too good. So what happened to this most omnipotent company?

Imagine a soldier's uniform made of a special fabric that allows him to look in all directions and identify threats that are to his side or even behind him. In work that could turn such science fiction into reality, MIT researchers have developed light-detecting fibers that, when woven into a web, act as a flexible camera. Fabric composed of these fibers could be joined to a computer that could provide information on a small display screen attached to a visor, providing the soldier greater awareness of his surroundings.

Joyalukkas Jewellery is one of the world’s favorite jewelers, with a retail chain of more than 70 showrooms across the Middle East, India, and Europe. The company has grown over the past two decades to become a household name for the wide range of contemporary, ethnic, and traditional jewelry it provides.

Joyalukkas commits to offering its customers the highest standards in quality and service across all of its outlets. The company identified that implementing a strong quality management system (QMS) throughout its operations was vital to being able to ensure this, and key in helping it achieve its goal of becoming a global brand by "ornamenting the world."

Upholding quality throughout expansion

Since starting with a single showroom in 1987, the Joyalukkas chain has expanded to include more than 70 showrooms (including the world’s largest jewelry showroom, located in Chennai, India) each offering 43 different brands of jewelry sourced from around the globe.

"Innovate at all costs!" This is the exhortation from innumerable business articles and best-selling business books. These authors describe how to innovate but fail to include how to find the time to innovate. What's needed is a tool to help find the time to think about and act on innovation. The Law of 90–10 [aka 90/10 principle, or theory, or rule] can be used as just such a tool to identify opportunities that, when addressed, create time for innovation.

The Law of 90–10 states that 90 percent of one statistic is attributable to 10 percent of another. A familiar example of this phenomenon can be seen in world wealth distribution where 10 percent of the world's population commands nearly 90 percent of the world's wealth. This can also be seen in most organizations where 10 percent of its members produce 90 percent of the results; witness the rainmaker or the star researcher.

I remember reading a book when I was younger, about a girl who was separated from her family during the Westward Migration, and forced to live on her own in the wilderness of early spring in 1860s America (unfortunately I don’t remember the name of the book). At one point in the adventure, the young heroine came upon an abandoned Indian settlement, where she was able to find some place to live (torn and tattered but protection from the elements), as well as meager amounts of grains left behind in the food storage cave (enough to make a few meals). She found corn, wheat, etc. and proceeded to make herself some gruel; after she finished eating her fill, she realized in dismay that she had used the entire supply of corn, and therefore would not be able to set aside any seed to plant for the upcoming growing season. She discovered the hard way that without planning, sustainability is endangered.

Organizations are not as short-sighted as the heroine; hopefully we all realize that if we continue to use resources at a greater rate than they can be regenerated, then we will be in for a very rude, and possibly irreversible, surprise… and are taking steps to ensure that we are responsible stewards of our planet.

(Mettler-Toledo Inc.: Columbus, Ohio) -- Marzipan has its origins in the Orient, where it was served at the caliph's table as a special delicacy, and for a long time in Europe, marzipan could only be enjoyed by the elite such as crowned heads, princes, and ladies of court. Today, Niederegger marzipan—the epitome of Lübeck marzipan—is one of the most exclusive confectionary delicacies, as it is still made from expensive specially selected Mediterranean almonds.

Niederegger, the Lübeck marzipan maker, produces marzipan products of the finest quality that even surpass the quality requirements for fine-grade "Lübecker Edelmarzipan." It's possible to taste it in each one of the more than 300 Niederegger specialties, which are produced from raw marzipan paste made 100 percent from the finest ingredients.

The secret of the traditional recipe for Niederegger marzipan is the exact ratio of almonds to sugar and a secret ingredient that is similar to rosewater.

(Mettler-Toledo Inc.: Columbus, Ohio) -- Marzipan has its origins in the Orient, where it was served at the caliph's table as a special delicacy, and for a long time in Europe, marzipan could only be enjoyed by the elite such as crowned heads, princes, and ladies of court. Today, Niederegger marzipan—the epitome of Lübeck marzipan—is one of the most exclusive confectionary delicacies, as it is still made from expensive specially selected Mediterranean almonds.

Niederegger, the Lübeck marzipan maker, produces marzipan products of the finest quality that even surpass the quality requirements for fine-grade "Lübecker Edelmarzipan." It's possible to taste it in each one of the more than 300 Niederegger specialties, which are produced from raw marzipan paste made 100 percent from the finest ingredients.

The secret of the traditional recipe for Niederegger marzipan is the exact ratio of almonds to sugar and a secret ingredient that is similar to rosewater.

With the proliferation of 3-D scanning technologies, many options are available for obtaining an electronic 3-D file of a scanned object. The quality of results varies widely. Of those that have experienced poor results, some complain about the accuracy of the data. Others have voiced concern over the usability of a completed file, having found that it does not work for their particular application.

In a recent poll, 57 percent of respondents that had used scanning services said they received “successful” results less than 80 percent of the time. A full 21 percent said that success was achieved less than half the time. While this information may be shocking to some, it is no surprise to others. It has become all too common for first-time users of 3-D scanning services to find themselves shopping for a better solution, or worse yet, discouraged from using scanning services again.

Through the 1990s, the application of a quality system relied primarily upon the Food and Drug Administrations’ (FDA) good manufacturing practice requirements or the FDA 21 CFR Part 820 Quality System Regulation. At that time, the international standards for quality management systems (QMS) were ISO 9001, ISO 9002, or ISO 9003, depending upon the scope of the organization’s quality system. Fast forward to 2009 and in the medical devices manufacturing industry, we now rely primarily upon ISO 13485 and the FDA Part 820 Quality System Regulation (QSR) to assure compliance. ISO 13485 and the quality system regulation are the de facto standards utilized by medical device and in vitro diagnostic companies for compliance with QMS requirements. There are other regulatory standards that may be specific to regions or countries that must be reviewed separately for organizations specific needs.

In this article, we will discuss how to utilize these standards for assuring harmonized compliance and assist in marketing devices around the world. We will focus primarily on ISO 13485—"Medical devices—Quality management system—Requirements for regulatory purposes," and how this international standard is utilized for meeting global regulatory requirements.

For process manufacturers, regular calibration of instruments across a manufacturing plant is common practice. In plant areas where instrument accuracy is critical to product quality or safety, calibration every six months—and even more frequently—is not unusual. However, the final step in any calibration process—documentation—is often neglected because of a lack of resources or the pressure and time constraints of everyday activities.

Many manufacturers are outsourcing all or some of their calibration maintenance activities, so now the contractor, too, is under pressure to calibrate plant instruments quickly and accurately. The contractor must also ensure the results are documented for quality assurance purposes, and provide full traceability.

The purpose of calibration itself is to determine the accuracy of an instrument or sensor. Although technology has greatly improved the accuracy of instruments, regulatory bodies often need to know just how inaccurate a particular instrument is and whether it drifts in and out of specified tolerance over time.