Jeffrey G. Stark is president of Sensor Products Inc.

odern microprocessor-controlled electronics and high-power LED lighting operate at elevated temperatures due to Joule heating. As a result, heat sinks, to dissipate temperature, have become important in electronic system designs.

Microprocessor temperatures should be maintained between 60° to 90°C (140° to 194°F), depending upon the specific chipset. This is because applications can microprocessors can malfunction causing freezes or crashes if operating temperatures exceed manufacturer recommendations.

LEDs suffer higher maintenance and shorter lives when their temperatures exceed 125°C (257°F). This is due to the forward voltage dropping when heating occurs; the result is increased current and heating. Thermal runaway can subsequently occur unless the excess temperature is removed. Small copper-plated holes in printed circuit boards are used to transmit heat away from low-power LEDs. However, heat sinks are needed for high-power LEDs. In addition, forced-air convection is used to remove heat from the fins of the heat sink.

Ken Appel is the manager of regulated industries for Veriteq.

In part 1 of this article, we discussed the pros and cons of various systems for stand-alone monitoring instruments (e.g., chart recorders and data loggers) and wired networks, with and without power over Ethernet (POE). In the second part of this article, we will look at two types of wireless monitoring—Wi-Fi and mesh—and continue the discussion of the risk factors (figure 1) and costs of ownership (figure 2).

Click on image to enlarge.
Figure 1: General guidelines to risks associated with meeting good manufacturing practices (GMP) requirements

Ken Appel is the manager of regulated industries for Veriteq.

T

he U.S. Food and Drug Administration (FDA) and its European Union counterparts recently agreed to cooperate on pharmaceutical plant inspections to enable stepped-up enforcement of safety guidelines. These agreements will help regulators be more efficient with their resources, but they also will require every pharmaceutical manufacturer to be on higher alert to maintain a best-practice focus on its quality systems. Mutual agreement among agencies, combined with a focus on risk-based processes, raise the likelihood of more GxP facilities being audited. Now is the time to revisit cost-vs.-benefit analyses for continuous monitoring systems (e.g., wired or wireless networks, and standalone monitoring instruments) that facilitate proof of regulatory compliance.

B

efore Michael Mercer established his consulting company, he accumulated more than 30 years of quality improvement experience at 3M. That experience led him to develop a deep trust in the power of Minitab Statistical Software. He began using one of the earliest mainframe computer versions to solve quality challenges in 1973, and he continued to rely on the software to improve processes throughout his distinguished career at 3M. Along the way, he watched the software evolve to include more features designed to meet the needs of quality practitioners with each new release.

Food safety standards are becoming increasingly stringent. Although government legislation has long been implemented, your customers may be driving an even higher standard of food safety through the Global Food Safety Initiative (GFSI) or Safe Quality Food (SQF) Institute, which require third-party audits.

The GFSI is a global collaboration between leading food-safety experts from retail, manufacturing, and food-service companies, as well as service providers associated with the food supply chain. The initiative is coordinated by The Consumer Goods Forum, the only independent global network for consumer goods retailers and manufacturers worldwide. It serves the CEOs and senior management of nearly 400 members in more than 150 countries.

Bob Kill is president and CEO of Enterprise Minnesota.

For manufacturers that watched their businesses decline as original equipment manufacturers (OEMs) opted to transfer their supplier relationships to cheap-labor countries such as China and India, there is now solid evidence that those contracts are coming back home. Some solid advice to go with this: It will pay to get ready.

I’ve heard repeatedly from manufacturers that offshoring is quickly, even dramatically, losing its appeal for OEMs. Gone are the extraordinarily inexpensive costs of overseas labor paired with favorable exchange rates that made hiring foreign suppliers a no-brainer.

Sean Mowry, left, president of Metal Craft, talks about strategic opportunities with Bob Kill, president of Enterprise Minnesota

Other issues have cropped up for the offshoring OEM set as well: Product quality is sometimes suspect, intellectual property frequently lacks legal safeguards, and linguistic and cultural barriers often complicate training workers overseas. There are also frustrating lags in turnaround time.

Xing-Fei He is senior product manager at DALSA Corp.

Flawless brake operation is so essential to the safety of a vehicle that all brake systems have passed some type of safety testing before a driver ever gets behind the wheel. But how much better would you, as a driver, feel knowing that the raw brake discs of your motorcycle or minivan were inspected for any flaws even before brake assembly began? And from a manufacturing perspective, what if such an inspection yielded better quality while boosting profitability?

A custom-designed machine vision inspection system from Ibea GmbH, headquartered in Hamburg, Germany, uses cameras from DALSA to provide these benefits and more for automotive suppliers, manufacturers, and customers alike.

Putting the brakes on faulty parts

Manufacturers tend to rely on manual inspections to detect nonconformities on raw brake discs. Frequent shift changes and the subjective nature of these inspections lead to lower reliability and, subsequently, to increased manufacturing costs resulting from returns.

Rob Snoeijs is a freelance technical writer for LayerWise.

LayerWise, a company based in Leuven, Belgium, focuses on selective laser melting (SLM), a powerful technology that shapes any desired metal-part geometry by melting metal powder layer by layer. Using this digital approach, the optimum shape of complex circulation parts can be produced in a single manufacturing step. Such a part delivers better performance and is more reliable than the complicated assembly it replaces. Furthermore, SLM technology is the right choice for small metal products, of which thousands can be produced simultaneously. In addition to countless industrial applications, the company manufactures revolutionary orthopedic, maxillofacial, and dental implants.

In 2008, wheel-alignment machine builder Burke E. Porter Europe NV (BEP) approached 3-D measurements specialists LMI Technologies Inc. for advice. At the time, BEP was developing plans to improve performance for end-of-line wheel alignment with its series of noncontact-alignment (NCA) machines. These measure toe and camber, displaying the results as guides for operators to make the necessary adjustments to bring vehicle parameters within the customer-specified values.

The issues

BEP realized that noncontact alignment needed higher precision, robustness, and a user-friendly plug-and-play interface. It recognized that the way to achieve these goals would be to start at the beginning with a radically new view on the measurement technology.

Existing sensor technologies based on single-laser line profiling had proven to be a dead end. An ambitious start toward capturing a full 3-D image of the wheel had been carried through to a prototype stage when LMI Technologies was contacted.

My definition of “specification” is rather simple: It’s a promise.

Just like any other promise, you’d better be sincere when you make it and be able to keep it. Failure to keep a promise brings disappointment. Frequent failure leads to distrust. And consciously breaking a promise is nothing less than deceitful.

Just as in our personal lives, the pharmaceutical industry makes a promise to its health care professionals and patients every time it establishes a product specification.

Whether it is a raw material or component from a supplier, in-process material, or final product, a specification is the industry’s promise to provide a product that possesses the attributes known to make it work.

Anything outside of the specification range is either unknown, because it has not been studied, or known to have some probability of a negative effect. Neither is acceptable.

The same could be said for process control ranges. Although they are applied to the manufacturing process and facilities, they nonetheless are “promises” based on a scientific field of study with respect to product quality.

Thus it seems to be particularly egregious when specifications and process controls are capriciously established or changed.