JANUARY 2012, VOLUME 51/NUMBER 1 WWW.QUALITYMAG.COM
RISK MANAGEMENT FOR
MEDICAL DEVICE MANUFACTURERS p. 48
NEW COLUMN: GD&T WORKSHOP p. 24 BEST PRACTICES FOR SENSOR SYSTEMS p. 34 TODAY’S ENVIRONMENTAL TEST CHAMBERS p. 38 FMEAS FOR THE MEDICAL INDUSTRY p. 44
rs o s I n ER IS H e T T S AF E D & ED 56 SI IN n AT p. io LOC is V U SS
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TABLE OF
CONTENTS QUALITY MAGAZINE
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JANUARY 2012
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VOLUME 51
38
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NUMBER 1
DEPARTMENTS 6
FROM THE EDITOR
Predicting the Future 8
INDUSTRY NEWS
Toyota Recalls Select Models Ford Focus Seats Made from Recycled Waste Materials Source: ESPEC North America
Post-Crash Fire Prompts Safety Study 18 FACE OF QUALITY
Focus on the Vital Few 20 OTHER DIMENSIONS
Cal Labs Aren’t Always Right 22 LEGAL INSIGHT
The Employee Handbook
FEATURES
24 GD&T WORKSHOP
A Top Down View
QUALITY MEASUREMENT
34 BEST PRACTICES FOR DEVELOPING SENSING SYSTEMS Make use of available resources and different management environments.
QUALITY TEST & INSPECTION
38 FLASH FORWARD TO TODAY’S ENVIRONMENTAL TEST CHAMBER By replacing that aging chamber, you will benefit from improvements in technology.
QUALITY SOFTWARE
28 QUALITY 101
Considerations for Measuring Large Precision Bearings 32 QUALITY INNOVATIONS
The Heartbeat of Automation 52 CASE STUDIES
Five-Axis CMM Inspection Lets “Good Times Roll” Going to Great Lengths
44 FMEAS FOR THE MEDICAL INDUSTRY Failure modes and effects analysis is a process to be used and not a form to be filled out.
QUALITY MANAGEMENT
48 A CLOSER LOOK AT RISK MANAGEMENT FOR MEDICAL DEVICE MANUFACTURERS A requirement forces manufacturers to establish a formal process for dealing with risk management and focuses on how manufacturers can produce safer products.
62 QUALITY PRODUCTS 67 CLASSIFIEDS 68 ADVERTISING INDEX
NEXT MONTH 3-D Measurement Thread Inspection GR&R Quality Leadership 100
JANUARY 2012, VOLUME 51/NUMBER 1 WWW.QUALITYMAG.COM
ABOUT THE COVER RISK MANAGEMENT FOR
Completing risk management to ISO 14971 is nothing new for medical device manufacturers. During the past
MEDICAL DEVICE MANUFACTURERS p. 48
several years, there has been more of a global alignment within this industry. Specifically, both the FDA in the United States and the Medical Device Directive in the European Union have made risk management compliance for ISO 14971 a requirement. This requirement actually forces manufacturers to establish a formal process for NEW COLUMN: GD&T WORKSHOP p. 24 | BEST PRACTICES FOR SENSOR SYSTEMS p. 34 TODAY’S ENVIRONMENTAL TEST CHAMBERS p. 38 | FMEAS FOR THE MEDICAL INDUSTRY p. 44
E rs o s n R e TE S AF IS
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dealing with risk management and focuses on how manufacturers can produce safer products. Source: Intertek
D & ED SI IN n AT p. 56 io C is LO V
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Available On-Demand Are You a Whole Team? Taking a whole-team approach has proved vital in getting the most out of teams developing software using agile practices. However, whatever industry or business your team is in, the described remedies can prove beneficial in improving team effectiveness and enhancing deliverable quality. NVision Helps Reverse Engineer Optical Retailer’s Store Display A national marketing services provider recently used NVision Inc.’s Engineering Service Division to reverse engineer an essential part in a store display for one of the nation’s largest optical retailers. NVision was able to quickly scan the part and provide the CAD files necessary to mass-produce it for the display in the retailer’s stores nationwide, enabling millions in annual sales. Readers Respond: What Quality System Software Would You Recommend if Starting a Company’s Quality Manual from Scratch? Members of Quality Magazine’s LinkedIn Group offer up their own answers to this question. Do you have a response? Share your comment today.
Industry experts share their views on the latest in quality and manufacturing: • Jim’s Gems: Weekly Updates! • Shifting the Paradigm
CAD-Based Inspection Using Contact Measurement Eddy Current Testing: Its Many Benefits and Applications 3-D Optical Microscopy— Correlating Industrial Surface Metrology to Enhanced Product Performance
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The Importance of ISO 50001
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Calibration Management Software: Important Factors Manufacturers Need to Know AS 9100 Revision C–What You Need to Know The Importance of SPC to Quality Management Systems
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QUALITY | January 2012
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FROM THE EDITOR
PREDICTING THE FUTURE SETTING THE FUTURE STARTS WITH IMAGINATION AND INNOVATION.
H DARRYL SELAND
arvard psychologist Daniel Gilbert posed in his book, “Stumbling on Happiness,” that, “the human being is the only animal that thinks about the future.” In other words, it is our imagination that sets us apart as a species. Armed with knowledge of the past and present, and with a vision of the future, many set off on a path to try and predict the future. It happens all around us. Every year, football fans and analysts alike quote statistics, play out arguments or just rely on gut feelings to make their predictions for the winner of the Superbowl. Whether these fans’ predictions are motivated by potential monetary gain or not, one place where it most decidedly is is Wall Street. Investors, brokers and traders brave the chaos of the trading floors every day trying to predict the future of companies and commodities around the world, investing money in companies poised to make a profit and selling the stock of those they believe will fail. In fact, so many are engaged in sorting through market data and analyzing the health of companies, that some perceive the markets as efficient, a hypothesis originally proposed in the 1960s by Dr. Eugene Fama, who believed “stock prices are ensured by the ready availability of ample information and by the vast number of rational investors avidly following each stock.” Others pour through this data in search of incorrect stock prices. They have a belief that the markets are inefficient and, therefore, present an arbitrage opportunity, or a chance to make money on a company or stock that is priced lower than it should be, giving them a chance to purchase the stock of a company on the rise at a cheap price.
Whether you believe markets are efficient or not, few places have developed as many tools or theories on their trade as the financial sector. The shear number of equations and algorithms developed, or “invented,” to measure the health of a company is amazing. Not only do we as human beings have the ability to imagine the future, but also invent that which can get us there. The idea is evident in the famous quote from Robert Kennedy, “Some men see things as they are and ask why...I dream things that never happened and ask why not?” It is our ability to imagine the future that is the cornerstone of innovation. Innovation leads not only to new methods and inventions, but also the improvement of existing products and practices. And I am not just talking about taking an existing product and sticking a clock in it. Check out this month’s Quality feature, “Flash Forward: Today᾽s Environmental Test Chamber” and see what’s being done to improve test chambers. Also, discover new ideas taking shape in sensing systems with Norm Axelrod’s article, “Best Practices for the Development of Sensing Systems for Production and Quality Control.” As always, enjoy and thanks for reading!
Darryl Seland, Editor in Chief
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CORPORATE DIRECTORS Publishing: John R. Schrei Corporate Strategy: Rita M. Foumia Information Technology: Scott Krywko Production: Vincent M. Miconi Finance: Lisa L. Paulus Creative: Michael T. Powell Directories: Nikki Smith Human Resources: Marlene J. Witthoft Events: Scott Wolters Clear Seas Research: Beth A. Surowiec
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PEOPLE NEWS The ASM Philadelphia Chapter (Hatfield, PA) named MIKE MCVAUGH, president of Laboratory Testing Inc. (LTI), as the 2011 Eisenman Award recipient. The annual award is presented in recognition of dedicated service to ASM, foresight, leadership and promotion of the metals industry and metallurgical education. McVaugh received the award at the October 20, 2011, Chapter meeting and made a presentation on the topic, Technology Has Taken Testing to a New Level, which covered the evolution of materials testing at LTI over the past 27 years, including broader capabilities, equipment enhancements and tighter quality control. The first Armand V. Feigenbaum Lifetime Achievement Medal was presented to YUANZHANG LIU, research professor of the Academy of Math and System Sciences, Shanghai, China. He received this medal in recognition of his promotion of total quality management in China for more than 50 years during which time he accomplished many firsts. Some of them are: • He founded the first research group of TQM for China in 1957. • He opened the first training seminar on quality control in China in 1957. • He was the first to write a series of weekly articles to introduce quality control in Workers Daily in 1979. • He was the first to start and host a TV program on TQM in 1979. • He was first editor and chief of the China Quality Magazine.
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QUALITY | January 2012
TOYOTA RECALLS SELECT TOYOTA, LEXUS MODELS TORRANCE, CA—Toyota Motor Sales USA announced that it will conduct a voluntary safety recall involving approximately 283,200 Toyota and 137,000 Lexus vehicles to replace the crankshaft pulley on the V6 engine. There is a possibility that the outer ring of the crankshaft pulley may become misaligned with the inner ring, causing noise and/or illumination of the discharge warning light. If this condition is not corrected, the belt for the power steering pump may become detached from the pulley and the driver may notice a sudden increase in steering effort. There are no reports of accidents or injuries related to this condition. The vehicles involved are: • 2004 Avalon • 2004 and 2005 Camry, Highlander, Sienna and Solara • 2006 Highlander HV • 2004 and 2005 ES330 and RX330 • 2006 RX400h No other Toyota or Lexus vehicles or these Toyota models with 4 cylinder engines are involved. Toyota is currently working on obtaining the necessary replacement parts. Once the replacement parts have been produced in sufficient quantities, Toyota will send an owner notification by first class mail advising owners to make an appointment with an authorized Toyota or Lexus dealer to have the crankshaft pulley inspected and if necessary, replaced at no charge. The owner notifications will be mailed by first class mail beginning this month.
SEAT FABRIC IN NEW FORD FOCUS ELECTRIC USES RECYCLED WASTE MATERIALS DEARBORN, MI—The new Ford Focus Electric features seat fabric made of recycled material that includes the equivalent of more than 20 plastic bottles per car. The fiber, called Repreve, is made from a hybrid blend of recycled materials and manufactured by Unifi Inc., a global sustainable textile solutions company. Unifi officials say 22 plastic, 16-ounce water bottles are used in the seat fabric of a single Focus Electric. The figure is based on the amount of Repreve branded fiber used in the production of fabric in each vehicle. The 2012 Ford Focus Electric also runs on battery power alone, requiring
no gasoline and producing zero carbon dioxide emissions. In 2009 Ford mandated that fabric suppliers use a minimum of 25% recycled content for all 2009 and beyond model year vehicles. Since then, 37 different fabrics meeting the requirements have been developed and incorporated into Ford vehicles. Carol Kordich, lead designer of Sustainable Materials for Ford, says Ford is taking it a step further by mandating that fabric be 100% sustainable in vehicles with eco-conscious powertrains like Focus Electric. Repreve fits the bill, she says, because it is a combination of post-industrial fiber waste and post-consumer waste, like the plastic water bottles made of
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polyethylene terephthalate plastic. Using Repreve also reduces energy consumption by offsetting the need to use newly refined crude oil for production. Repreve meets all Ford performance requirements, says Kordich, and Ford already is considering other uses across its entire car and truck lineup. Ford’s reduce, reuse and recycle commitment is part of the company’s broader global sustainability strategy to reduce its environmental footprint while at the same time accelerating the development of advanced, fuel-efficient vehicle technologies around the world. In November, Ford announced it is using 25 20-ounce plastic bottles to make the carpeting in every all-new Ford Escape utility vehicle it builds. It is the first time Ford has used this type of carpeting in an SUV. Over the past several years Ford has concentrated on increasing the use of nonmetal recycled and bio-based materials whenever possible, provided these materials are environmentally favorable in the specific application. Examples include soy foam seat cushions and head restraints, wheat straw-filled plastic, castor oil foam in instrument panels, recycled resins for underbody systems, recycled yarns on seat covers and natural-fiber plastic for interior components.
POST-CRASH VOLT FIRE PROMPTS NEW SAFETY STUDY DETROIT, MI—Federal regulators, stressing they see no consumer safety issue, have launched a new study of lithium-ion batteries in electric vehicles (EVs) after a battery pack for a Chevrolet Volt caught fire three weeks after the car was crashed in a side-impact collision test. The Volt fire occurred in June at the National Highway Traffic Safety Administration’s test facility in Wisconsin, where the wrecked Volt was being stored. Since then, NHTSA has contacted all major automakers with EVs in their lineups or in the future product plans with questions about lithium-ion battery safety. Both General Motors and NHTSA have tried to replicate the post-crash fire but have not been able to, a GM spokesman says. While lithium is highly flammable and there have been several instances of lithium-ion batteries in laptop comput-
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Spectroscopy specialist Starna Scientific (Essex, England) has appointed NATHAN HULME to the role of director to help guide the company’s expansion plans. Hulme’s main responsibilities will include assisting in setting out an overall business strategy for the company that will address communications with customers and dealers as well as involving leadership of the sales team.
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Transcat Inc. (Rochester, NY), a distributor of professional grade handheld test and measurement instruments and accredited provider of calibration, repair and other measurement services, has appointed LEE D. RUDOW to the role of chief operating officer.
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ers catching fire, automakers use multiple safety systems in their EV battery packs to safeguard against heat build-up and other “thermal incidents” that could lead to EV battery fires. GM suggested in a statement that the fire at the NHTSA facility occurred because testers did not de-energize the Volt’s battery after the side-impact crash test and stored the wrecked car with a live battery pack. It appears that coolant that leaked after the crash came into contact with the battery and was ignited. NHTSA, which is looking into automakers’ procedures for “draining” EV batteries after collisions, said in a statement that it has no reason to believe that electric vehicles are any more dangerous—or fire prone—than conventional gasoline vehicles. Separately, Nissan North America, which has been selling the all-electric Leaf hatchback since December 2010, says that
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there have been no reported incidents of a Leaf battery fire. Both the Volt and the Leaf have been given 5-star crashtest safety ratings by NHTSA. The agency said that its chief concerns in the wake of the Wisconsin blaze is that tow operators, wrecking ad storage yard personnel and safety responders all are aware of the need to de-energize EV batteries and of the process involved. More than 8,000 Leafs and 5,000 Volts are on the road in the United States and only two other Volt-involved fires have been reported and neither has been a lithium-ion battery fire. In the most recent case, a garage at a North Carolina home burned on Oct. 30 and early speculation centered on the home charging station in the garage. But in a recent report, the Green Car Reports blog quotes a Mooresville, NC, fire investigator as saying that his preliminary findings in a much-reported garage fire involving a Volt show that neither the car nor the home charging unit was the cause. The Volt was hooked up to the charging station and early reports speculated that the charger had malfunctioned. But the deputy fire marshal for the county said his early findings show that the blaze started elsewhere in the garage and then involved the Volt and the charging station. GM, Nissan, NHTSA, Siemens—maker of the charging station—and power supplier Duke Energy all have sent investigators to the Mooresville fire site. In the first incident a garage in Connecticut burned, destroying a Volt and a homemade Suzuki-based electric car that was parked next to it. Fire investigators determined that the fire did not originate with either vehicle or their chargers. Jim Federico, GM’s chief engineer for electric vehicles, said in a statement that the company “is working with other vehicle manufacturers, first responders, tow truck operators and salvage associations with the goal of implementing industry-wide protocols” for safe handling and storage of electric vehicles and their batteries in the aftermath of a crash. GM, he says, has its own protocols to “depower the battery of an electric vehicle after a significant crash” and has engineered the Volt with multiple on-board safety systems. The Volt, he says, “is a safe car.”
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NEWS GE’S SENSING BUSINESS GETS GOVERNMENT GRANT TO DEVELOP UK METROLOGY CENTER GROBY, LEICESTER, UNITED KINGDOM—The Groby manufacturing site of GE’s Sensing business, part of GE Energy, Measurement & Control Solutions, has been awarded £4.2 million ($5.76 million) over the next five years from the U.K. Government’s Regional Growth Fund (RGF). The funding will be used to help the company to develop its GE U.K. metrology center and to continue its investment in advanced pressure sensor design and manufacture, creating innovative products for harsh environments, ranging from aerospace to sub-sea oil and gas production. The RGF is a £1.4 ($1.89) billion fund operating across England from 2011 to 2014. It provides targeted support for businesses to allow them to expand and create jobs. The award is recognition of GE’s significant growth over the past few years and acknowledges and supports its planned investment in innovative technologies for a wide range of market segments, which will sustain existing jobs at the Groby site as well as creating a number of highly skilled, engineering and advanced manufacturing posts. As Groby Site Leader Tim Povall explains, “We already are seen in GE as a Center of Excellence for pressure technology and can point to recent important developments such as our 4Sight calibration and maintenance software and our TERPS pressure sensor technology. This new funding will help us to continue to build our research and development capabilities and establish a world-class metrology center for GE in the East Midlands.”
NO NEW U.S. PLANT FOR MAXED-OUT HYUNDAI ANN ARBOR, MI—With explosive U.S.-market sales virtually demanding the company find a way to get more cars into customers’ hands, Hyundai Motor America is not ready to commit to a second assembly plant in the United States, president and CEO John Krafcik told reporters at a media event at the company’s technical center near Ann Arbor, MI, in November. Krafcik insists that despite a meteoric post-recession sales climb and excruciatingly thin inventories for many models, Hyundai has not
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made the decision to build another U.S. assembly plant to add to its current site in Montgomery, AL, that started production in early 2005. Along with the Korea-based Hyundai Group’s affiliated Kia Motors America’s assembly plant in West Point, GA, the company currently has capacity to build about 400,000 vehicles in the United States—but the “problem” is that both Hyundai and Kia have been setting monthly and annual sales and market-share gains for several years—and record October sales for both brands were emblematic of their new front-runner status. In October, Hyundai and Kia surpassed their full-year 2010 sales performance, itself a record sales year for both; the two companies combined for 10-month sales just shy of 1 million units. In October, Hyundai’s year-to-date sales were up 21% (compared with its record 2010) and retail sales were up 31%. Hyundai’s looming supply crisis is underscored by its almost nonexistent inventories, which since the Japan earthquake in March have dipped to levels
ASSOCIATION NEWS THE COORDINATE METROLOGY SOCIETY (CMS, Benbrook, TX) has announced the results of its large-scale, interactive measurement study conducted at the 27th annual Coordinate Metrology Systems Conference (CMSC). The 58-page report entitled “How Behavior Impacts Your Measurement,” focuses on measurement strategies and behaviors of coordinate metrologists. More than 100 conference attendees participated in the data collection activity coordinated by the National Physical Laboratory (UK) assisted by members of the CMS Certification Committee. Metrology is the science of measurement, and professionals in this field work in diverse industries such as aerospace, automotive and power generation. During the two-day study, participants were asked to perform three tasks using portable 3-D coordinate metrology equipment for data acquisition: to measure a door using a combination of a laser tracker, retro reflectors and software; to measure an engine compartment using a combination of an articulating arm, probe and software; and to measure a vehicle using a combination of a laser tracker, probing and laser scanning system. The final report reveals various results based on 3-D measurement tasks executed with little or no instruction, as compared to the outcome of 3-D measurement tasks completed using procedures, or a participant guiding an operator with methodology to collect the needed measurements. The study was sponsored by Metrologic Group and its U.S. subsidiary ATT Metrology.
one-third of what is considered healthy. Hyundai says its days supply in July was 21 days, a low for the year, and things had scarcely improved by October, when the company set its new sales record for the month despite a 26-day supply. “We’ve got a lot of headwind, a lot of opportunity to grow the brand in the U.S.,” Krafcik says, while simultaneously sticking to the story that Hyundai, acutely concerned
about maintaining quality, is not considering another U.S. assembly plant. Hyundai’s U.S. boss did say the company is projecting a seasonally adjusted annual rate (SAAR) of sales in 2012 of about 13.5 million units (vs. the 12.8-million SAAR predicted for 2011), and says Hyundai “should at least grow with the industry next year.” The extra sales are not likely to
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NEWS come from increased output from the Group’s two U.S. factories, however (Kia’s Georgia plant makes the Santa Fe midsize crossover for Hyundai). Krafcik says the company already wrung out unexpected combined extra output of about 10% for 2011, mostly through increased efficiencies, so little more can be expected. Instead, he says, Hyundai sales will increase with incremental volume from new or
revised imported models, including an all-new Azera full-size sedan and a redesigned Genesis coupe and sedan, among others. But Krafcik’s admonitions that Hyundai is not working on U.S. expansion plans sound increasingly less convincing. The Alabama plant, which makes the popular new Elantra compact car and its bigger counterpart, the Sonata midsize sedan, is running
flat-out and was scheduled to make about 330,000 vehicles in 2011, not to mention the high-volume 2-liter and 2.4-liter 4-cylinder engines used for the Sonata and Kia’s Optima. The plant also is adding construction of the Nu 1.8-liter 4-cylinder engine family, used in the Elantra. Unless another economic or natural catastrophe rears up to grenade sales, it seems inevitable Hyundai must address its stretched-to-the-max production.
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McLEAN, VA—September U.S. manufacturing technology orders totaled $606.56 million according to the American Machine Tool Distributors’ Association (AMTDA) and The Association For Manufacturing Technology (AMT). This total, as reported by companies participating in the USMTO program, was up 22.9% from August and up 51.9% when compared with the total of $399.32 million reported for September 2010. With a year-to-date total of $4,074.00 million, 2011 is up 91.9% compared with 2010. These numbers and all data in this report are based on the totals of actual data reported by companies participating in the USMTO program. “September numbers were the second highest monthly dollar total in the last 15 years,” says Peter Borden, AMTDA president. “American manufacturers are still rushing to beat the end-of-year bonus depreciation deadline.” The United States Manufacturing Technology Orders (USMTO) report, jointly compiled by the two trade associations representing the production and distribution of manufacturing technology, provides regional and national U.S. orders data of domestic and imported machine tools and related equipment. Analysis of manufacturing technology orders provides a reliable leading economic indicator as manufacturing industries invest in capital metalworking equipment to increase capacity and improve productivity. U.S. manufacturing technology orders also is reported on a regional basis for five geographic breakdowns of the United States: • Northeast. At $112.75 million, September manufacturing technology orders in the Northeast region were
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up 74.6% when compared with the $64.56 million total for August and up 71.9% when compared with September a year ago. The year-to-date total of $612.93 million is 65.0% more than the comparable figure for 2010. Southern. September manufacturing technology orders in the Southern region totaled $78.04 million, 34.5% more than August’s $58.03 million and 16.1% more than the September 2010 total. With a year-to-date total of $513.08 million, 2011 is up 63.2% when compared with 2010 at the same time. Midwest. Midwest region manufacturing technology orders in September stood at $175.88 million, 3.7% less than the August total of $182.55 million but up 48.9% when compared with last September. At $1,376.97 million, the 2011 year-todate total is 119.6% more than the comparable figure for 2010. Central. Manufacturing technology orders in the Central region in September totaled $170.82 million, up 22.4% from August’s $139.55 million and up 48.1% when compared with the September 2010 figure. The $1,098.33 million year-to-date total is 92.0% higher than the total for the same period in 2010. Western. Western region manufacturing technology orders totaled $69.07 million in September, 41.9% more than the $48.66 million total for August and up 109.1% higher than the tally for September 2010. At $472.69 million, 2011 year-to-date is up 98.0% when compared with last year at the same time.
AUTOMATE AND PROMAT TO COLOCATE IN 2013 CHICAGO—Automation Technologies Council (ATC) and the Material Handling Industry of America (MHIA) announce that the Automate Show and Conference will once again colocate with ProMat in 2013. Both exhibitions will be held January 21-24, 2013, at Chicago’s McCormick Place. Automate 2013 is an event for robots, vision, motion control and related automation solutions in North America. ProMat is the premier material handling and logistics show held in North America. The colocation of
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events is the latest effort by ATC and MHIA to help end users find solutions to their manufacturing and supply chain challenges. “We had such terrific feedback from attendees and exhibitors in 2011 that it made perfect sense to build upon and expand our colocation in 2013,” says Jeff Burnstein, president of ATC. “We’re looking forward to an outstanding Automate event that
educates current and potential users on how automation solutions can help them improve productivity; boost product quality, speed time to market, reduce costs and become stronger global competitors.” “The decision to colocate ProMat 2013 and Automate 2013 was an easy one after the successful collocation of these events in 2011,” says George Prest, COO for MHIA. “The coloca-
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CHENNAI, INDIA—Caterpillar Inc. will build a $150 million engine manufacturing facility in India that will produce Perkins branded 4000 Series engines. Perkins is a subsidiary of Caterpillar. The company is also investing an additional $62 million in its existing off-highway truck manufacturing facility in Chennai. The new investment to expand truck capacity in Chennai is in addition to a $108 million investment for Chennai that Caterpillar announced in 2010. Together these new investments will help support customers in India and other growth markets, and are part of Caterpillar’s goal to be the leader in its industry in India.
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FACE OF QUALITY
FOCUS ON THE VITAL FEW ORGANIZATIONS NEED TO FOCUS ON THE RIGHT BEHAVIORS.
W JIM L. SMITH
hile the economy is sputtering and attempting a comeback from one of the worst recessions in history, organizations are challenged with reinventing themselves as a means to survival. This isn’t much different than in the past as most of the effort centers on trying to become the low-cost producer. Success, however, with this transformation is that it must be accomplished without compromising quality. Recently in one of our quality management courses, the class was discussing their organization’s current recovery efforts. One of the students commented about reading an article on organizations’ need to let go of old assumptions and take a different approach to their performance improvement initiatives. Over the next two months this column will discuss 10 vital tips organizations and their quality professionals should cultivate to bring about positive results. These 10 tips are not just for challenging times but would be effective in any environment and circumstance. 1. Keep the end goal in focus. Studies suggest that in as many as 80% of all initiatives, managers focus on less important things rather than their goals. Organizations need to focus on the important issues that will allow them to achieve their primary goals. They need to find ways to deal with the day-to-day challenges without allowing distractions. A good methodology that has proven helpful to many organizations is Hoshin planning, which was developed by Dr. Yoji Akao. It combines the basics of total quality management and Shewhart’s PDCA (plan-do-check-act) improvement concepts. The key objective is to emphasize the creation of the vital few in order to ensure that all employees comprehend and focus on the things that are most important. 2. Make crisis an ally. It seems many organizations regularly operate in crisis so why not exploit the situation? If not done already, it is a good time to craft action plans for specific cost improvements and initiatives. The current climate of economic uncertainty offers an ideal opportunity to drive change. Organizational resistance is low, and the workforce is more willing to change daily work practices. Workers have already discovered quicker, easier methods to perform assignments. In normal times they are not typically willing to volunteer these improvements, which would translate into changing work standards. This is a great time to rally the troops to become synergistic and work toward common, shared goals of
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QUALITY | January 2012
improved quality and greater efficiency. The key is to involve as much of the workforce as possible. 3. Solicit help from all levels. It may come as a surprise but senior-level managers don’t always have the solution. I know because I’ve been one of them. Certainly management holds the keys to the success engine. However, the engine is propelled by the energy generated at the factory level and supplied by the workers. Organizations that focus attention and technology at the worker level to improve individual performance will see sustained transformational results. Organizations need to create a synergistic environment that will encourage worker ownership and empowerment. This will provide the energy for the success engine that will pull the organization to the front of the competition. 4. Don’t take metrics at face value. It is not unusual for middle managers to exaggerate, or misrepresent, their efficiency, often by as much as 10%. Metric calculations are often skewed, flawed or too focused on the lower levels rather than on the operational causes of performance loss or waste. Because of blurred results, management routinely sets the bar for improvement against incorrect baselines, which obscures the potential for true improvements. Create clear, understandable and accurate performance metrics. 5. Too many metrics confuse and hinder real improvement. Most companies have far too many metrics, which confuse their organizations and hinders improvement. With so many metrics only a few people know what actions really drive the metrics; therefore, people focus on the wrong things. Too many resources are spent collecting and reporting data which produce little or no improvement. In many cases this leads to something Dr. Deming called analysis paralysis. Organizations fail to provide a framework of meaningful metrics to empower the workforce to properly identify issues and to resolve problems in real time. This stifles most organizations and prohibits real and sustained improvement. Managers who are routinely disappointed by not seeing more improvement to the bottom line shouldn’t have to look too hard for the reasons. Next month’s column will address five more vital tips for organizations. Jim L. Smith has more than 45 years of industry experience in operations, engineering, research & development and quality management. You can reach Jim at
[email protected].
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OTHER DIMENSIONS
CAL LABS
AREN’T ALWAYS RIGHT THE GAGE USER HAS TO JUSTIFY CALIBRATION FREQUENCY.
A
reader wrote me recently of a situation he was trying to sort out with a couple of his calibration sources. Some of their comments left me shaking my head in wonder, but that’s not uncommon these days when so many are still not accredited. Here are some examples from my reader and others.
HILL COX
DUE DATES ON REPORTS My reader sent out some adjustable thread rings for calibration and requested that a due date beyond one year be shown on the report. The lab advised him that they were “not allowed” to do this. A discussion ensued and my reader had trouble making the lab understand that it is up to the customer to make such decisions—not the cal lab. A quick look at ISO 17025 confirmed this to be the case. It clearly states that any such statement on a report must reflect what the customer wants, not what the lab A calibration report thinks it should be. is a summary of the state This makes sense because the gage owner of the item calibrated at that is privy to the condipoint in time. tions of use and the lab is not. And the owner knows what the potential use is going to be for the gages as well. That doesn’t make the owner an expert in these matters, but he or she has more critical information needed to make the call that the lab does not have. It goes without saying but I must—some gage owners look at calibration frequency based on economics rather than performance. This can be very dangerous and I can understand a laboratory recoiling in horror. The best thing a lab can do is advise the customer when their request is off the wall. Yes, some auditor will read the report, and not understanding ISO 17025, will think the lab is out to lunch when the due date decision was made by their customer. If the customer doesn’t want to change the due date, the lab could put a footnote on the report indicating that the due date was determined by the customer. Alternatively, the due date could be f lagged with a note suggesting that it be reviewed by the customer. I find it interesting that so many people want a due date on a report, or cal labs put one on without discussing it with the customer. The creators of ISO
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QUALITY | January 2012
17025 were concerned that disreputable labs could use this as a method to drumming up business. As a result of this situation, the standard doesn’t require a due date to be put on a report. A calibration report is a summary of the state of the item calibrated at that point in time. After it leaves the lab anything or everything can change. A due date, however created, could be made obsolete by a number of factors such as: • An accident that may require an item to be calibrated sooner than what the cal report says to confirm it is still within the limits. • A review of the calibration data may indicate to the customer that the due date should be changed. That will only become apparent after the calibration report with a now inappropriate due date is received. • Disputes between departments or manufacturers and their customers often can trigger recalibration. • Your customers may indicate they want changes to your due dates. Too many gage users want a due date on the report so they don’t have to justify their choices to an auditor. If it’s on a report from a reputable lab, an auditor is unlikely to question it, so the user gets a free ride. At the end of the day, however, the gage user has to justify calibration frequency irrespective of who made the judgment call. I believe the due date should be part of the gage record so its history is traceable along with reasons why changes may have been made. Under this scheme, you don’t have a report stating one thing while your frequency has been extended or compressed. The item itself will have a status sticker on it with a due date and when that sticker is missing, damaged or illegible, the gage record will note what it should be. Now, all you have to figure out is how to express the date so it will fit in the space on the sticker and the format you use is understood by all who need to know. Being a simple kind of guy, I think it’s hard to beat “May/12.” Hill Cox president of Frank J. Cox Sales Ltd. (Brampton, Ontario, Canada). He may be reached at
[email protected].
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LEGAL INSIGHT
THE EMPLOYEE HANDBOOK HOW CAN IT LEGALLY PROTECT AND IMPROVE YOUR BUSINESS? “Point 1 - Create constancy of purpose toward improvement of product and service, with the aim to become competitive and to stay in business, and to provide jobs.” – W. Edwards Deming
S
imilar to a quality manual, an employee handbook can improve employee relations and efficiency, BRYAN L. ensure consistent treatment of personnel and legally BERSON ESQ. protect an organization. Employees (and independent contractors) want to know what managers expect of them, what their rights are and what is prohibited. By clearly communicating their expectations to personnel, managers are more likely to obtain compliance. Within an organization, important policy information may be scattered throughout a variety of interoffice memoranda, e-mails, bulletins, newsFor a handbook to be effective, letters and pamphlets. New employees will not an organization must instill a have access to all of the old materials. Employhabit of consistently using it. ees may not have access to policy information provided to managers. One department may not have access to information provided to another. This creates misunderstanding. Without a guide, employees will ask repetitive questions about company policy, forcing managers and personnel departments to answer similar questions. The answers may be inconsistent. If policies aren’t written down, managerial and employee turnover results in a loss of institutional knowledge. Some employees may be too embarrassed or intimidated to ask questions. Thus, some employees resort to using their best judgment. They may simply do what they perceive everyone else to be doing. This can lead to further inconsistency and serious problems. Creating a handbook does not have to be difficult. A skilled attorney can help managers develop one that meets the organization’s workplace needs. The process of drafting a handbook forces managers to think critically about jobs and employment relationships. They should consider which personnel policies work and which should be improved. Soliciting employee ideas and feedback through interviews and questionnaires can be valuable. Top executives and managers make a handbook authoritative by explicitly endorsing it with their signatures and creating a culture that uses and fol-
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lows it. The handbook must describe its purpose. Management then outlines all important personnel policies including those with respect to: hiring; hours; compensation and incentives; benefits; vacation and personal time; performance; training; workplace behavior; privacy; trade secrets; and grievances, among others. Handbooks also legally protect employers. Some labor and employment laws require employers to provide employees with certain information. Handbooks are an obvious place to include these policies. Management should include a disclaimer that the handbook is not a contract and does not create one. Nearly every state recognizes the doctrine of “employment at will,” which gives employers the right to terminate employment at any time for any reason. (Montana provides employees with special protections against severance. In all states, employees may always quit because the 13th amendment to the Constitution prohibits involuntary servitude.) On the other hand, if an employee and employer have a contract, the employer cannot simply fire the employee. Severing an employee before the expiration of the contract would result in a breach of the contract, thereby making the employer liable for damages. A poorly drafted handbook may inadvertently create an implied contract by promising that employees will not be severed without a legitimate business reason or if they are doing good work. Unrealistic promises, even if well-intentioned, can create legal and business problems for organizations. For a handbook to be effective, an organization must consistently use it. If it remains on the bookshelf gathering dust, it won’t do any good. It must be written in plain English so employees and managers understand what the policies mean. In a misguided attempt to save money, some organizations simply copy another company’s handbook and change the title page. To be effective, a handbook must be tailored to a company’s specific needs. It also must be periodically audited and updated. It will evolve with the needs of the organization and improve it. Disclaimer: This column is for informational purposes and does not constitute legal advice. Bryan L. Berson, Esq. is an attorney, mediator and the president of The Berson Firm, P.C., a commercial and civil law firm specializing in business law, real estate, mediation and litigation. He may be reached at
[email protected].
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GD&T WORKSHOP
A TOP DOWN VIEW o what is GD&T anyway? For some people it’s a grim, depressing and troublesome burden, whose importance they question deeply. For others it’s grand, delightful and terribly important, and the only reliable basis for specifying machine part geometry. As must be well known, in order to define things which we want other people to manufacture for us—in particular machine parts—there are two essential requirements. First, we must define their fundamental geometry. Secondly, because no physical object can be perfect, we must specify just how imperfect they may be and still function. The two tools for doing these two things are: CAD (computeraided design) and GAD (GD&T aided design). CAD provides the means to generate, manipulate and unambiguously communicate the perfect nomi-
nal geometry of an object. GAD, on the other hand, provides the means to investigate, determine and unambiguously communicate permissible limits of imperfection to guarantee the assembly and operation of an object. CAD without GAD is very “bad” because it represents just half the story, and CAD with “bad” GAD is even worse, because it implies the stated requirements are reliable when they are merely decorative and misleading. In addition to GAD there is the classical alternative for specifying permissible limits of imperfection, namely classical dimensioning and tolerancing (CD&T), but it consists solely of the “±” tool and is just as bad as bad GAD, because it depends entirely on tribal understandings, is beholden to no rules and is therefore just as prone to mislead.
THE ORIGINS OF GAD As Stanley Parker, the alleged inventor of GD&T, discovered early one frosty morning in 1940, CD&T is essentially useless. After his team had spent a whole day rejecting a run of the last critical parts for a shipment of torpedoes by Her Majesty’s Torpedo Manufactory in Alexandria, Scotland, Parker set them carefully aside in order to return the next day to do some additional checks before initiating a new manufacturing run. However, when he arrived, he discovered they were all missing. As it turned out, anxious to make the shipment on time, the night assembly crew was delighted to find the missing parts neatly stacked in the inspection department, and in the wee hours installed the parts, proved they were perfectly functional, and released the shipment. Upon learning this, rather than recalling the shipment and firing the assembly manager for criminal behavior—a highly justifiable response under the circumstances—Parker congratulated him on his pluck and set to work to understand how he, Parker, could have rejected a set of perfectly functional parts. In the process he tore CD&T apart in an effort to discover possible weak-
CD&T
Decorative GD&T
Functional GD&T
What is geometric dimensioning and tolerancing (GD&T)? B Y B ILL TANDLE R
S
A R80
R80
4X 60°
4X 60°
R80±0.1
4X 60°±0.1°
Break Edges
Break Edges
Break Edge 80
0
A B AN EXAMPLE OF THE GD&T CHALLENGE The drawings shown here represent three different attempts to specify permissible limits of imperfection for a vacuum flange which includes a pattern of threaded bolt holes which must be mutually tightly located but only loosely constrained relative to the center of the periphery of the flange, and of which one planar surface must be extremely flat to ensure an airtight seal with a mating O-ring, and the other reasonably parallel, but only loosely located relative to the first. In addition, the flat edge of the flange must be tightly perpendicular to the vacuum face and tightly located relative to the bolt hole pattern in order to accurately orient and locate a mating part. We’ll analyze the drawings in our next column. Source: Multi Metrics
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QUALITY | January 2012
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BALL BAR - DUMBELL nesses, and since weaknesses were all that he found, he set to inventing a more reliable set of tools, namely the gift of GD&T which not only links permissible limits of imperfection to function, but specifies them so precisely that others can do precisely what they specify. Today we are the proud inheritors of Parker’s symbolic language—now referred to as GD&T—which represents a set of tools with which to not only communicate design intent unambiguously to manufacturing and inspection, but, much more importantly, with which to ensure that what we communicate is worth communicating, namely represents functional, assemblable parts. THE GIFTS OF GAD GD&T is a highly sophisticated encodable and decodable symbolic language for managing the risks involved in machine part design, manufacturing, inspection and assembly. It serves first to force the designer to research the functions of
each feature of a part, because if not properly understood, said functions can never be properly encoded. Secondly, it serves to bring to light possible shortcomings in the geometry of certain features of a part to perform their required functions. As a result, it encourages refining the geometries of those features to improve their ability to perform their functions and as a result leads to the creation of more fault tolerant designs. Thirdly, GD&T provides the means to unambiguously specify preliminary limits of imperfection to enable mathematically reliable tolerance stackup analysis, which in turn enables refinement of said limits to guarantee assembly and operation, all prior to drawing release. It is only with GD&T that tolerance stack-up analysis becomes a scientific endeavor; it is only with GD&T that we can unambiguously specify manufacturing objectives; and it is only with GD&T that metrology becomes a fully automatable, scientifically reliable process.
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GD&T WORKSHOP The lack of functional GD&T is demonstrably responsible for bumpy new product ramp up cycles, unnecessarily costly manufacturing processes and unavoidably questionable inspection results, all based on tribal understandings, however, companies are so accustomed to experiencing these problems that they cannot imagine a small investment in GD&T could significantly reduce them. But it can, and in fact, GD&T is not only a gift, but a necessity for an organization which cares about getting it right the first time and which cares about the bottom line. PATH TO SUCCESSFUL GAD Unfortunately, however, grasping GD&T, and making it work, turns out to be somewhat troublesome. This is because its symbolic language needs to be just as rich and complex as the real world of what can go wrong. In order to master GD&T and enable it to produce the bottom line benefits of which it is capable, we must start with absolutely crystalline sets of concepts, tools and rules, which the ASME Y14.5 and ISO 1101 standards attempt to provide, but sometimes with limited success. Next, with these in hand, we need well-organized, precisely stated processes for encoding and decoding GD&T—something not addressed in the above standards. Finally, we also need well-documented sets of best practices in order to successfully turn what appears to be a jungle into a veritable English garden. With these foundations in hand, the final need is for intelligent, software based automation of the encoding and decoding processes in the CAD, CAM and CAI (computer aided inspection) worlds. Although in its early stages, automation has begun to be addressed in CAI and CAD, but still has a substantial distance to go. Maybe it’s time to start demanding it from suppliers of these products, if you haven’t already. Editor’s note: We encourage readers to submit questions, and we will attempt to provide succinct answers to as many as possible. Bill Tandler is the president and chief technical officer of Multi Metrics Inc. (Menlo Park, CA). He can be reached at GDandTWorkshop@ qualitymag.com or (650) 328-0200.
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QUALITY | January 2012
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Learn to see your data.
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X=34.25
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QUALITY 101 Building a dimensional gage for checking a very tight tolerance on a large part includes many of the same concepts required for any precision measurement. Bearing tolerances are much too tight for hand gages such as an ID micrometer, or a large caliper, and many CMMs have neither the capacity nor the accuracy. In many cases, the only option is to build a custom gage for the family of parts to be measured. Source: Mahr Federal Inc.
CONSIDERATIONS FOR
MEASURING LARGE PRECISION BEARINGS Despite their size, all the elements of good gaging come into play with large precision bearings. BY GEORGE SCHUETZ
M
echanical bearings, including ball, roller, taper roller, needle, spherical and cylindrical, to mention a few, have been in use for hundreds of years, with countless designs, applications and sizes, and just as many measurement requirements that need to be defined and verified. With today’s emphasis on miniaturization, one would think the measurement of tiny bearings is the biggest challenge—just think of having to handle and measure all the components of a 0.10 inch diameter bearing. But the measurement of extremely large bearings—such as those used in power turbines, wind generators or large earth moving equipment— also are a challenge. Here we’re looking at bearings that measure anywhere from 12 inches to 20 feet in diameter. Despite their large size, these bearings still need to be inspected to meet design and manufacturing requirements, and in many cases, the toler-
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QUALITY | January 2012
ances involved are not that different from small bearings. The key specifications for bearings include numerous linear dimensions, as well as form and surface finish characteristics. The challenges are many when doing such measurements on extremely large bearings, not only in the gaging process itself but many times in just handling the parts. Often, gages must be used on the shop floor because the parts are too large to be carried to a measurement lab in the far corner of the building. This brings environmental considerations into play. For example, thermal expansion is much greater on large parts than small, and vibration can be more problematic on a tall gage column than on a smaller one. Indeed, all the elements of good gaging—defined by the acronym SWIPE: standard, workpiece, instrument, people and environment—come into play with large precision bearings. Let’s look at the particulars by specification.
DIMENSIONAL MEASUREMENTS The first series of checks usually done are to make sure the part is correct dimensionally. And since bearings tend to be round, diameters need to be measured. Inside diameters (IDs) and outside diameters (ODs) are probably the most common dimensions measured on the shop floor and there are endless methods of doing so. But few of these methods reach the level of precision required for bearing tolerances, let alone work on some of the sizes required. Building a dimensional gage for checking a very tight tolerance on a large part includes many of the same concepts required for any precision measurement. Bearing tolerances are much too tight for hand gages such as an ID micrometer or a large caliper, and many coordinate measuring machines (CMMs) have neither the capacity nor the accuracy. In many cases, the only option is to build a custom gage for the family of parts to be measured. For the tolerances required, longrange scales are generally not accurate enough, and a comparative gage tends to offer the best performance. With a comparative gage you have to have masters (or qualified parts) to set the gage. Just as you would have for a bench gage measuring a 3-inch bearing component, you also need a master for a 36-inch part. Having a good reference is critical to making the measurement. Sometimes, though, there may not be masters or qualified parts for each particular set up. For such cases, a gage design that incorporates precision measuring heads and a reference ball can use gage blocks to set the radius of the part—and thus the gage—to measure the diameter. Also important is having the ability to easily manipulate the part to allow measuring at different heights
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Tolerances are often as tight on large bearings as on small, and comparative gaging procedures are the same. Gage size and robustness, however, are not. Source: Mahr Federal Inc.
When bearings get to the 20-foot diameter range, they can get pretty heavy. And since the typical form machine is designed around parts that are less than 12 inches in diameter, form machines for large bearings need to be “beefed up.” Source: Mahr Federal Inc.
and diameter locations. Manipulating a 36-inch part is a lot different from a 3-inch part. What’s needed is to have the gage manipulate the part to the commanded position. Designing a gage that can position the part reduces the time an operator handles it, helping in two ways. It relieves the operator of the need to handle heavy parts, preventing
injury, and it also reduces one of the biggest sources of error in the shop: parts that are not the same temperature as the gage. Since the amount of thermal expansion on a large part is very significant, the less an operator touches it the better. Then there are large bearings that have very thin walls; so thin that hold-
ing their shape is very difficult, particularly when gaging force is applied. In these cases special fixturing consisting of six measuring heads can be used to help “round up” the part. These fixtures also can provide additional valuable information to the manufacturer. Because each measuring head works independently, there is increased capa-
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QUALITY 101 bility for part analysis. For example, these six heads provide: • Three 2-point diameters • Average diameter • Two 3-point diameters • Total indicator runout (TIR) values. Because these six heads do a lot of averaging, they will produce very repeatable readings despite rotating the part to multiple points on the part diameter.
In addition, special equations have been developed to compensate for the six points of gaging pressure being used. FORM MEASUREMENT When bearings get to the 20-foot diameter range, they can get pretty heavy. And since the typical form machine is designed around parts that are less than 12 inches in diameter, form machines for large bearings need to be “beefed up.”
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The first issue to consider is the base of the machine. A large base adds stability, absorbs vibration and provides a foundation to stage the part. Any vibration that passes through the machine gets amplified as it moves up the structure. The more you can eliminate vibration in the base, the less error will show up in the measurement. Then there is the rotary table for large bearings. For large capacity, air bearings are the only practical choice. Air bearings have all the characteristics required: heavy load capacity (thousands of pounds), excellent axial stiffness, and an air cushion that absorbs vibration and reduces the potential for damage if a part is accidentally placed a little too hard on the table. Another area to look at is the vertical stand and horizontal arm which holds the sensing probe. The mass of these components is a key factor: they need to be tall and have enough reach to get at all the parts within the range of the table. But without sufficient mass, they will magnify any vibration coming up through the base and shake the arm like a string of spaghetti. The last area to consider is the number of counts that can be obtained from the rotary encoder. To collect form analysis data for the part, a digital encoder is built into the table. On large diameter parts, circumferences can become enormous. It is important to have a rotary encoder that has as high a resolution as possible. The higher the resolution, the more data points that can be collected, which means better analysis of the whole surface and more accurate results.
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QUALITY | January 2012
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SURFACE TEXTURE AND CONTOUR With some of today’s portable handheld surface gages having 30 parameters available, along with the ability to store and retrieve data, most measurements are easy and can be taken in virtually any orientation, regardless of the size or location of the part. Portable gages offer a wide range of available probes to allow for measuring just about anywhere on the part and provide the parameter required. But while measuring surface finish is relatively easy, there are usually more parameters than just finish requirements called out on large bearings. Many bearings have curved races in which the balls run. Surface finish is
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important to reduce friction on these tracks, but also critical is the form or curvature of the track. If the curvature is not correct, the ball will not ride in the correct location, or too much pressure will be applied to the balls which will produce heat and result in early failure of the bearing. For this measurement a contouring gage needs to be used to trace the races and other areas on the bearing. A contour gage has a long arm, capable of very long range and high resolution, allowing for curvature analysis of the races. Staging and mass are important for this measurement—as they are for other measurements—but special vibration isolation also is necessary, since the contour probe is so sensitive and extremely susceptible to vibration.
For this application large air vibration isolation pads are a must. The gage holds the part at a slight angle and keeps it in place with adjustable guides to allow the contour system to be positioned at the proper location. PRECISION NATURE OF TASK In measuring extremely large bearings, size matters. Not only must gages be robust enough to accommodate extremely heavy parts, but they must also be able to manipulate parts. They must allow measurements of high precision, be able to operate in shop floor environments, and do so with enough operator ease and efficiency to keep pace with the manufacturing process. Consideration must be given to issues such as gage mastering, thermal expan-
sion and vibration, and the ability to accommodate and analyze increased data from longer part traces. Finally, operators must approach large bearing measurement with the appropriate mindset. It is intuitively hard to grasp the fact that a bearing many feet in diameter and weighing perhaps several thousand pounds can have the same tolerance requirements as a 3-inch roller bearing. But they do, and unless care is taken and operators are fully sensitive to the precision nature of the task, measurement results will be less than adequate. George Schuetz is director of precision gages at Mahr Federal Inc. (Providence, RI). For more information, e-mail
[email protected] or visit www.mahr.com.
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31
INNOVATIONS
THE HEARTBEAT OF
AUTOMATION Envision enterprise solution helps companies to optimize automation processes, minimize unnecessary maintenance and increase production throughput. BY DARRYL SELAND, EDITOR IN CHIEF
Envision provides a detailed and easy to understand view of each station. Source: Beet Analytics Technology
Previously unseen and untapped real-time process performance data can be easily accessed and monitored at your fingertips, either on-site or remotely. Source: Beet Analytics Technology
Envision remembers and stores every anomaly (deviation from targeted cycle time) of each operation over a set period of time. Source: Beet Analytics Technology
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QUALITY | January 2012
I
n the realm of process diagnostics and quality management, Envision’s Automation Intelligence System technology could be considered a quantum leap beyond traditional motion sensing diagnostics tools. Whereas existing diagnostic tools use vibration sensors or other signals, Envision creates digital traces of all sets of events pertaining to the automated or manufacturing processes. “Envision makes what is invisible be visible,” says David J. Wang, CEO and CTO of Beet Analytics Technology (Plymouth, MI). “It leverages existing sensors in the system and uses them as timing devices to capture the heartbeat of any automated process. The amount of data that is captured and processed by Envision is massive. We overcome tremendous technical hurdles to make this new set of data available.” In capturing the heartbeat, Envision’s solution “listens” to the rhythm of machine and automated operations, illuminates untapped and currently invisible process data to pinpoint possible problem areas before a critical failure and transforms how a system’s operational and quality performance is measured and managed. The software monitors and records every automated motion and process in real-time, acting as an EKG of sorts, comparing the actual process performance against design-intended cycle time to gauge the health of the system. “Even though we are decades into the digital age, our manufacturing floors are still in the digital dark age. Every second, thousands or even millions of financial transactions, blogs, twitters, phone calls, SMS messages and others are recorded in the digital universe,” says Wang. “At the same second, millions of motions and operations are completed in tens of thousands of manufacturing processes or automated processes, yet there is no recorded digital trace.” According to Wang, Envision makes digitizing these motions and operations possible, enabling them to be measured, analyzed, inspected and tested. “With Envision,” says Wang, “we will be able to provide the ‘single point of truth’ of all manufacturing processes.” For Beet Analytics Technology, the idea of “machine heartbeat” software was born in 2009. “Control, safety and data network had recently and finally converged into one network thus opening the door for a new
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kind of automation diagnostics software that could leverage the power of the computer to give more intuitive, historic and predictive automation diagnostics to the end user,” says Wang. A team comprised of control engineers and IT software developers— including the two main inventors of Envision, who combined have more than 36 years of combined experience in both control engineering and information technology—was formed to develop the concept into a software product in the second quarter of 2009. “They were able to see this new possibility and created the foundation for Envision,” says Wang. After 18 months of development, the beta version of the software was released and piloted on a major automaker’s assembly line in November 2010. Envision Version 1.0 was officially released October 2011 after more than two-anda-half years of development. According to Wang, the response to Envision has been extremely positive. “During the last two decades, the advancement in software has not been focused on the shop floor or manufacturing. With the proliferation of computer-aided and ERP systems, the industry has been able to digitize most of the engineering, finance, purchasing and other back office operations in any given enterprises,” says Wang. “There is no enterprise system out there to digitize the real manufacturing processes down to every motion on the factory floor. There is a huge vacuum in applying information technology to help manufacturing getting better and smarter. The market is waiting for something like Envision.” According to Wang, the software can be applied to any automated or semi-automated control process from an automated assembly line to a rollercoaster ride in an amusement park to just about any process with predefined sequence and time constraint. “We have been piloting in an automotive OEM assembly factory for the last 12 months,” says Wang. “We have conducted proof of concept pilot with an electronic manufacturer.”
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January 2012 | QUALITY
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MEASUREMENT
Best Practices for Developing
Sensing Systems FOR PRODUCTION AND QUALITY CONTROL Make use of available resources and different management environments. BY DR. NORMAN N. AXELROD
S
monitor-display times. This number was ensing and control systems’ best plausible but apparently picked out of practices, for development and thin air. At this speed, each photosenstroubleshooting, usually result in fasting unit had to sense and provide other er, less costly and improved quality and functions in a time span of less than product control systems. 100 milliseconds. Best practices have TECH TIPS The sum of the acquibeen defined in the Four practices stand out sition times for all photoHarvard Business Review among those that we have sensors must be less than as “straightforward, seen applied successfully in 100 milliseconds. At least actionable advice for novsystem development: three standard imaging ice managers, seasoned » Simplify/relax specifications in planning stage. cameras (with acquisition leaders and people at all times of 30 milliseconds levels in between.” This » Use a master craftsman each) were considered definition emphasizes during troubleshooting of for determining ovality “actionable advice” over malfunctioning system. of a critical implantable more rigid restrictive » Use practical information on medical component or a definitions requiring operations and history. total of 90 milliseconds. repeatable, replicable, » Control or exploit the In addition, sensing time nonidiosyncratic features. competitive corporate for common industrial Four practices stand environment. sensors is often 10 milout among those that I liseconds or more. have seen applied successWith seven more single photosenfully in system development. sors (possible acquisition times of these single industrial photosensors SIMPLIFY/RELAX can be 10 milliseconds) the total SPECIFICATIONS IN acquisition time would be 90+70 or PLANNING STAGE 160 milliseconds, which is greater For planning an online optical sensing than 100 milliseconds needed for system for quality and product control, total acquisition of 0.1 second (or with nine or 10 sensors and four local 100 milliseconds). In addition, computers, I met with the technical other operations have time requirefolks. The goal was to improve the ments including inputting numbers measurement system while improving into files, sensing data to a central the cost-benefit ratio without sacrificcomputer for processing and storing performance. age, maintaining and changing the One of the stated requirements was visual displays on a video monitor, to sense and store data from all sensors self-calibrating procedures and selfevery 10th second (or 100 milliseconds) monitoring procedures. including data processing, storage and
1
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QUALITY | January 2012
The initial design specifications could be made to work, with more complex, expensive hardware and software, and with attention paid to the actual response times. However, it appeared better to reduce costs and build in safety margins for existing issues, as well as allow for anticipated but unidentified new issues that often occur in new projects. In a meeting with technical folks, I asked how long it takes, when the current system detected a problem, for corrective action to be taken. The reply: about 5 minutes. I suggested that data be collected once per minute. Everyone agreed. This would significantly expand the time allowed for sensing, data processing, communications and display, as well as reduce the storage requirements without reducing functionality. This, and other similar practical simplifications of specifications, reduced the cost of the system by more than 30%. It simplified hardware, software and development. It permitted some expansion of the system functionality. The system was completed and satisfactorily tested on schedule. The system was completed, tested and used by production-line operators. It met the General Manufacturing Practices requirements and has been used satisfactorily for years with data collection taken from sensors once per minute.
2
USE A MASTER CRAFTSMAN DURING TROUBLESHOOTING OF A MALFUNCTIONING SYSTEM Having appropriate tools available during troubleshooting can increase effectiveness. Such tools should include a combination of appropriate human, testing and modification capabilities.
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In particular, rapid, effective lowercost troubleshooting has been obtained by having a master craftsman available during tests and redesigns. The master craftsman should have the tools and skills to modify components of the system as useful design changes are identified. The system in question was an optical communication system used with a computer-controlled brain-surgery system to remove brain tumors. The patient’s head was imaged in three-dimensions by X-rays, and the image was saved digitally. The patient’s head was then mechanically held in place. The display monitor showed the saved image of the inside of the patient’s head as well as the superposed location of the tip of the surgical knife. The position of the surgical knife was transmitted to a remote receiver, 5 to 10 feet away, using a light emitting diode source on the knife. However, the receiving optics of this communication system had been unreliable and the goal of this trouble-shooting was to identify and eliminate the cause. The procedure was straightforward. Several functional tests were done on the communication receiver for different relative locations of the surgical knife and the receiving station. I then proposed a modification of the receiving optics. The system engineer who had been working on the system showed me the system and the available resources. The corporate master craftsman and I discussed the modifications that were thought to be required. This consisted of using the existing components to point out the perceived problem, providing a hand-drawn sketch and talking him through the modifications. Then the engineer and I left so that the master craftsman could work without interruption. He was encouraged to contact us if he had any further questions. When we returned, the optics had been modified and inserted into the communication system: the system now worked in geometries which, before, had provided unreliable reception. Having shown that this approach was productive, we then went through two more modifications. Each modification improved the signal-to-noise ratio. Nominally, we were there. I then was told to provide a report with calculations/computing results for what had been done, as well as for any
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additional modifications that might prove advantageous. The real-time adjustment process of master craftsman work with the consultant shortened the time to bring this product to market. There was no proposal by me for system troubleshooting as well as designing, fabricating and testing the initial modifications. The proposal preparation and subsequent evaluation by the company can take weeks, if not months.
It helps to have faith in the expertise of the outside troubleshooter for this to work.
3
USE PRACTICAL INFORMATION ON OPERATIONS AND HISTORY Hands-on experience and day-to-day operating issues can be obtained from engineers and on-line operators who work on quality systems. Be sure to
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MEASUREMENT schedule folks to talk with as early as is practical. In one example, we had designed an online laser-based system to gage the diameter of red-hot tubes—several inches in diameter—that were coming out of an annealing furnace. The design was to be presented to managers of this manufacturing plant. Before the meeting, I talked to the operations engineer. He told me that
they had bought and tested a gaging system to do the job but that he had not seen it since the tests. On further questioning, he said that the only person at my presentation who knew about this was the plant manager. I presented my design. Nothing unusual was mentioned. At the end, the attendees started to leave, and I approached the plant manager and asked him about the previously tested
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QUALITY | January 2012
gaging system. He said that the previous system had burned up. How could it have burned up? I had been told that there would be significant distance between the optical gaging system and the rapidly moving tubes being gaged. He said that to verify the measurement of the purchased system, they pulled a hot tube off line immediately after measurement and, using rollers, moved it to within several inches from the gaging system. The gaging system melted. No one had mentioned this event, asked for a verification/calibration system for hot pipes or suggested that heat might be a problem. There are several simple straightforward solutions for such problems that avoid system meltdowns. CONTROL OR EXPLOIT THE COMPETITIVE CORPORATE ENVIRONMENT A highly competitive environment is generally the culture in system planning and development at many companies. Improving the employee’s advancement, real or imagined, takes precedence over the selecting the best route to achieving the immediate goal. It is rare, but I saw one corporation where the corporate culture apparently was one of cooperation. This had emerged from the company’s founding with the corporate goal of improving medical care by improving medical devices. This was a goal in which folks took pride. In addition, exploiting internal or external competition or a combination of both, outstanding systems can be developed. There are different scenarios for this. • Minimize competitive juices for a common good. In planning for development of a new quality control system for a critical medical device, one corporation formed a group consisting of highly qualified internal and external experts in all involved areas. In other companies, such discussions consisted primarily of attacks citing the weaknesses of the proposed suggestion. The objectives were described and folks suggested different approaches followed by discussion. The participants suggested non-obvious means to improve the suggested systems using their technological expertise. The company ethos was to do good by providing solutions that improved medical treatment. Everyone seemed
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to be proud of this and would spend extra effort and time in areas with which I had contact. This was true for development of quality inspection and control systems. All suggestions were respectfully considered, and the combined expertise was used to improve all suggestions. This not only improved suggestions, but also encouraged folks to make suggestions that they felt might lead somewhere. Use the cooperative team ethos where possible. Modify an overly competitive culture for productive ends. • Maximize competitive juices for a common good. Problems at a silicon integrated circuits manufacturing plant halted production. To address this, two different laboratories, at corporate R&D, were assigned the task of solving this problem, with the spoils to the winner. This fired the competitive juices of the engineers in both groups and the problem was solved in a short time. Here, exploiting the competitive approach provided successful rapid results. • Combine cooperation with competitive juices to defeat an internal threat. Easily the most outstanding example where internal cooperation and expertise, in response to an internal threat, led to the invention of the charge coupled device (CCD). The inventors Boyle and Smith won the Nobel Prize. Boyle and Smith were the lab director and department head of silicon/semiconductor development at Bell Labs. They were outstanding technologists and managers. The threat arose from magnetic bubbles. A single, small magnetic domain, with polarization up or down to represent zero or one, could be moved in a material from one location to another. This permitted digital information to be transferred from one location in a material to another location and to be stored and sensed for polarity. This threatened semiconductor/silicon dominance in digital storage and communications. The threat, it is ironic to note, came from a competing group working on magnetic bubbles within the corporation. Boyle and Smith met to size up the threat. They invented a means to move electrons from one location to another in silicon, using shaped and movable electric-potential wells
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that had the same features as the magnetic bubbles but were faster and in much-better developed material that had massive research and development done for silicon transistors. Silicon won: it was no contest. The different practices discussed for obtaining faster, better development of sensing systems make use of available resources and different management
environments. The successful examples discussed illustrate how to exploit or establish resources and how to exploit or modify existing attitudes/procedures to improve the work product. Q Dr. Norman N. Axelrod is an optical/laser system developer and consultant at Norman N. Axelrod Associates (New York, NY). For more information, call (212) 741-6302, e-mail naxelrod@axelrodassociates. com or visit www.axelrodassociates.com.
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TEST & INSPECTION
BENEFITS » New chambers include their own integrated controller with extended features and benefits suited specifically to temperature and humidity control. » All chamber manufacturers now offer mid-size models with fast temperature change rates that have a reasonably small footprint. » In the past decade, networking equipment for the Internet and cell phones drove test chamber sales, but today the new demand is from solar panels and lithium-ion battery products.
Flash Forward
TO TODAY’S ENVIRONMENTAL TEST CHAMBERS By replacing that aging chamber, you will benefit from improvements in technology. BY DAVID JUNG
R
emember back, maybe 20 years ago, when you were the newbie, sent down to the test lab for the first time? As simple as your boss made an environmental test chamber sound— it’s just a pizza oven with humidity or it’s just a freezer that goes hot too— actually using a chamber was much more trouble. Lucky for you it was in the lab, and you didn’t have to purchase or maintain the equipment at that point in your career. You did have to deal with the lab manager, who closely guarded his chambers. The controller was confusing, failures were mysterious and data collection was a chore.
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QUALITY | January 2012
Flash forward to today, where you are the boss and that lab manager is long gone, but that same test chamber is there. Now is a great time to replace that aging chamber in your lab. Not only will you have a more reliable machine, you will benefit from improvements in technology. CONTROLLERS GIVE ACCESS TO DATA The first digital controllers for test chambers were about as easy to use as MS-DOS, but without the keyboard. It took an expert just to set a single temperature point to run. Data collection was done by strip chart or circular
recorders on paper. Most of these controllers have been retrofitted on older chambers with generic process controllers such as a Watlow F4, which also have serial interfaces for data collection. New chambers now include their own integrated controller, with extended features and benefits suited specifically to temperature and humidity control. While one should not select a chamber based solely on its controller, each manufacturer’s proprietary interface and fixed capabilities will leave you scrambling to come up with new operation plans once you get your new machine. Data collection to a computer is de rigor, for example, but variations in interface types, file access and storage, as well as the data itself, may leave the operator happy or frustrated. Remote Web-based access is the current trend and has taken chamber use to an even higher level of user-friendliness.
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Look Beyond Compliance. At NSF-ISR, Competitive Performance is Key. ƵƚŽŵŽƟǀĞ DĞĚŝĐĂůĞǀŝĐĞƐ džƉĞƌƚĞƌŽƐƉĂĐĞ^ŽůƵƟŽŶƐ ŶǀŝƌŽŶŵĞŶƚ͕,ĞĂůƚŚĂŶĚ^ĂĨĞƚLJ dƌĂŝŶŝŶŐ &ƌĞĞǁĞďŝŶĂƌƐŽīĞƌĞĚƚŚƌŽƵŐŚŽƵƚϮϬϭϮ͘ ŽŶƚĂĐƚƵƐ͊ E^&/ŶƚĞƌŶĂƟŽŶĂů^ƚƌĂƚĞŐŝĐZĞŐŝƐƚƌĂƟŽŶƐ hŶŝƚĞĚ^ƚĂƚĞƐ dŽůů&ƌĞĞ͗ϴϴϴͲE^&ͲϵϬϬϬͮdĞů͗ϳϯϰͲϴϮϳͲϲϴϬϬ ŝŶĨŽƌŵĂƟŽŶΛŶƐĨͲŝƐƌ͘ŽƌŐͮǁǁǁ͘ŶƐĨͲŝƐƌ͘ŽƌŐ ĂŶĂĚĂ dĞů͗ϭͲϮϴϵͲϴϯϴͲϮϮϬϰͮĐĂŶĂĚĂΛŶƐĨͲŝƐƌ͘ŽƌŐ
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designed to ensure successful 510(k) ͻ džƉĞƌƚĐŽŶƐƵůƟŶŐ͕ƚƌĂŝŶŝŶŐĂŶĚĞĚƵĐĂƟŽŶŝŶŵĞĚŝĐĂů
ĚĞǀŝĐĞĚĞƐŝŐŶ͕ƚĞƐƟŶŐĂŶĚŵĂŶƵĨĂĐƚƵƌĞ ͻ/^KϭϯϰϴϱƌĞŐŝƐƚƌĂƟŽŶƚŚƌŽƵŐŚƐŝƐƚĞƌĐŽŵƉĂŶLJE^&Ͳ/^Z &ŽƌŵŽƌĞŝŶĨŽƌŵĂƟŽŶŽŶDĞĚŝĐĂůĞǀŝĐĞƐ͕ĐŽŶƚĂĐƚ͗
E^&WŚĂƌŵĂůLJƟĐĂ͕ϳϭϵDŝĚĚůĞ^ƚƌĞĞƚƌŝƐƚŽů͕dϬϲϬϭϬh^ ƚ͗нϭͲϴϲϬͲϵϰϬͲϲϱϱϬͮĨ͗нϭͲϴϲϬͲϵϰϬͲϲϱϱϮͮĞ͗ŶƐĨƉŚĂƌŵĂůLJƟĐĂΛŶƐĨ͘ŽƌŐͮǁ͗ǁǁǁ͘ŶƐĨͲƉŚĂƌŵĂůLJƟĐĂ͘ĐŽŵ E^&WŚĂƌŵĂůLJƟĐĂŝƐƉĂƌƚŽĨE^&/ŶƚĞƌŶĂƟŽŶĂů͛Ɛ,ĞĂůƚŚ^ĐŝĞŶĐĞƐŝǀŝƐŝŽŶ
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January 2012 | QUALITY
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TEST & INSPECTION Temperature changes under eco operation (example)
A new energy-saving thermal shock chamber has a compact footprint and can be integrated with other test equipment. Source: ESPEC North America
A temporary shutdown of the unused zone on thermal shock chambers results in energy savings. Then boosting the zone’s temperature setting prior to transfer significantly improves the temperature shock. Source: ESPEC North America
Shown is a conceptual view of chamber with safety features for battery testing. A false ceiling acts as an explosion vent. Source: ESPEC North America
Also, control and recording based on sample temperature—not air temperature—is commonplace.
troubles with test chambers. Larger and faster chambers had bulky refrigeration systems that were expensive to maintain. The refrigeration on today’s temperature chambers is rock-solid reliable and high performance is an accessible choice.
All chamber manufacturers now offer mid-size models with fast temperature change rates (5 to 20 C per minute) that have a reasonably small footprint. A new scroll type of compressor that is compact, powerful and reliable has made this possible, thus
REFRIGERATION GETS FASTER Back in the day, compressor failures and refrigerant leaks were expected
CMM FIXTURING Highly accurate, flexible components Designed for easy assembly and high repeatability. Eliminates the need to build dedicated fixtures.
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HUMIDITY: STILL A MYSTERY Humidity systems on older chambers were always mysterious and fussy. Today, manufacturers have each refined their own technology for generating and controlling humidity. Humidity may be generated by an inchamber water bath, an external steam boiler or an atomizer. Humidity detection and control may be via an electronic sensor or wet-bulb method. All are valid methods, but each has different operation and maintenance requirements, keeping them somewhat mysterious. Often the most trouble comes from end-users who do not understand the details of the system they own. CONSIDER THERMAL SHOCK If you are like most test professionals, a thermal shock chamber has been on your wish list for some time. The extreme temperature change caused by suddenly switching from a hot to a cold exposure zone is a tempting expansion of any lab’s capability. Operation costs and facility requirements have improved, but such a machine still remains a significant investment. Savings for thermal shock can be accomplished by reducing the number of defrost cycles. Running the cold zone at extremes such as -65 C constantly, it attracts moisture from the room, freezing on the cooling coil. The expansion and shrinking of the air volume due to the temperature shock also draws in moisture. In old thermal shock chambers, defrosting as frequent as every 10 temperature cycles was necessary. Improved sealing of the chambers, as well as added systems to purge the zones with nitrogen or dried air, has extended defrosting periods to 100 cycles. One new innovation is a bellows-type component that allows the volume of air in the chamber to change without sucking in room air, so that defrosting may be required only every 500 cycles.
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The latest integrated controllers can automatically manage operation to save energy and boost performance, taking advantage that one zone is always in standby mode. If the controller has the capability to temporarily turn off the standby zone, energy savings of up to 45% have been recorded. For improved performance, the standby zone can be temporarily set to a more extreme temperature than
the desired final condition, helping ensure a fast recovery. If a test calls for a -40 C cold cycle, for example, the chamber could run the air at -55 C in anticipation of a transfer from the hot zone. After the transfer, the temperature is controlled to ensure the product recovers to the desired -40 C temperature, albeit more quickly. This control feature can reduce the size of refrigeration
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