MADAM CASTER Quality Management Week 2 and 3 Re-do



Intro to Quality Management Week 3 




Air Bag Recall








Review the article “Blow Out” from this week’s reading assignment. This article pertains to the recall of air bag products. Assume you are the manager for a large automotive company that will be using air bags in your products. What risk assessment tools will you use in order to ensure that the product being installed into your vehicles meets safety standards in order to avoid a recall? Use your course materials and outside research to generate a solid analysis on why these methods would be helpful. Your analysis should be supported by research.




 Directions for obtaining the file: Login to the Grantham University library by clicking on the Resources tab from the main page. You will then log into EBSCOHost. Once you have accessed the database, simply copy and paste the title of the article and press enter to search and you should now have the file accessible to review.




The requirements below must be met for your paper to be accepted and graded:




•Write between 750 – 1,250 words (approximately 3 – 5 pages) using Microsoft Word in APA style, see example below.




•Use font size 12 and 1” margins.




•Include cover page and reference page.




•At least 80% of your paper must be original content/writing.




•No more than 20% of your content/information may come from references.




•Use at least three references from outside the course material, one reference must be from EBSCOhost. Text book, lectures, and other materials in the course may be used, but are not counted toward the three reference requirement.




•Cite all reference material (data, dates, graphs, quotes, paraphrased words, values, etc.) in the paper and list on a reference page in APA style.
















Business: Cars




Keywords: Safety; Automotive industry; Driving; Accidents; Brain; Congress; Design; Regulations; Vehicles; Weight; Fariello; Cars




Air bags are meant to save lives. Now a massive recall shows how they sometimes can turn deadly




Forensic Investigator Sal Fariello, whose job is to deconstruct car crashes, has witnessed a catalog of carnage caused by air bags over the past two decades. In his collection, there is a photo of a woman who has been horribly scarred by an inflating air bag. There's an X-ray of a driver's broken wrists snapped in the "fling zone" of an air bag that mashed both arms from a 10-and-2 position into the car's roof. He can cite numerous drivers who suffered torn aortas or lacerated brain stems, all the result of being "punched" by an air bag inflating at 200 m.p.h. (322 km/h). "What's sitting in the front of the steering wheel is an explosive device," explains Fariello, the author of Airbag Injuries: Causation & Federal Regulation. "Nasty, unexpected events can occur."




None have been nastier than the injuries and deaths caused by exploding inflators in air bags made by automotive supplier Takata Corp., based in Tokyo. Its air bags have been blamed for killing five motorists in the U.S. so far. More than 10 million cars from 10 makers—including BMW, Chrysler, Honda, Nissan and Toyota—have been recalled. On Nov. 26, the National Highway Traffic Safety Administration (NHTSA) ordered Takata to expand its most recent recall from a regional one to a national one. Takata declined on the basis that the problem is confined to areas like Florida with high relative humidity. Toyota and Honda are following NHTSA's advice and issued a national recall. All the cars are from model year 2011 or older.




Takata's suspect inflation canisters contain a propellant—tablets of ammonium nitrate—that is ignited at the onset of a crash to initiate a chemical reaction that produces nitrogen gas to fill the bag. Moisture may be destabilizing the ammonium nitrate. In the faulty inflators, the blast shatters the canister, sending metal shards through the air bag toward the driver. Arriving at the scene of one such incident, police thought the victim had been shot in the face before crashing. "My understanding is our products in this accident worked abnormally," said Hiroshi Shimizu, who is in charge of Takata's global quality assurance, when prodded by Nevada Senator Dean Heller during Senate-committee testimony on Nov. 20.




On Dec. 2, Toyota called for a joint industry initiative to independently test the Takata bags. "The safety, security and peace of mind for our customers are our highest priority, and I believe this is shared with all the other automakers," said Simon Nagata, CEO of Toyota's North American manufacturing unit.




Perhaps these scenes—accident reports detailing both gore and tragedy, congressional hearings well stocked with outrage, and executives who struggle for the right tone of response—should come as no surprise. It has, after all, been a very bad year for the auto industry. General Motors' recall of 2.6 million vehicles earlier in 2014 stemmed in part from defects that led to air bags' not deploying at all, causing injury and death.




But the Takata crisis once again reminds us that this foundational piece of auto safety equipment has always carried the risk of injury—and death—riding shotgun. People have been hurt because they are the wrong size, shape or age to get the optimal benefit from a device first designed for an average male. And now, in Takata's case, because of a defect.




How Did We Get Here?




An air bag in deployment has to first measure—and then counter—the considerable inertial forces that are brought to bear when your car crashes into another vehicle or object. In a collision, your car stops abruptly, but you don't. Your head and body keep moving forward, translating that energy according to Newtonian physics until some other force arrests it. Before the advent of air bags and seat belts, this "velocity debt" was repaid—at terrible cost—when your head or body smashed into the steering column or dashboard.




To stop your head's violent forward motion requires considerable counterviolence. After a car's accelerometers and sensors detect a crash pulse—the rapid deceleration that signals impact—an algorithm in the electronic control unit (ECU) then decides whether to deploy the air bag and at what pressure. If the ECU says deploy, the explosion that rapidly expands an air bag also hurtles it toward your head at speeds ranging from 98 m.p.h. to 200 m.p.h. (158 km/h to 322 km/h). In fact, the bag should be deflating by the time your head makes contact, creating a cushioning force that dissipates the energy of the crash by distributing it over the larger surface area of the bag. The entire process of sensing and deploying the air bag has to take place in 20 to 30 milliseconds, by which time your head has already moved forward five inches.




Air bags have been saving lives since 1973, when General Motors produced 1,000 Chevrolet Impalas equipped with air bags as an option. According to Byron Bloch, an auto-safety expert who has long campaigned for better air bags, Chevy produced a good one: a dual-pressure system that protected children from a fully powered air bag's potentially lethal force. GM was satisfied with the technology—the concept was patented in 1953—and Bloch said the company was ready to expand the program. "We were going to have dual-pressure air bags phased in the '74—'75 model year," he says.




Instead, air bags disappeared for nearly 20 years. Why? The Big Three auto companies, led by Ford boss Henry Ford II and his deputy Lee Iacocca, convinced President Richard Nixon that air bags wouldn't be cost-effective. The pressure on the Big Three to offer air bags ultimately came from smaller competitors, like Volvo, that made air bags standard equipment. With consumers clamoring for protection, Congress made air bags mandatory as of September 1998.




The design and testing standards of these late-1990s air bags, however, would not make them better than the ones GM used in the early 1970s. When two elderly women were killed by air bags in the early '90s, it was a lethal indication that there were flaws. "The elderly die very easily in car crashes," says Fariello, who has been a paid expert witness for both plaintiffs and defendants in injury lawsuits. The force of the deployed air bag, even in low-speed fender benders, was causing fatal chest and brain injuries. Short women were being injured because they moved their seats forward to reach the gas and brake pedals. As a result, their faces were within 10 in. of the steering wheel, which experts say is the minimum safety margin.




Auto-industry safety organizations, consumer groups, the Society of Automotive Engineers, NHTSA and the Insurance Institute for Highway Safety have debated test conditions for decades. NHTSA's frontal tests are run at 35 m.p.h. (56 km/h) into a rigid barrier using a crash-test dummy optimized for a 50th-percentile male—about 172 lb. and 5 ft. 9 in. (78 kg and 175 cm). Yet most crashes happen at speeds below 35 m.p.h., and they involve all kinds of people, objects and crash angles. Hitting a pole is different from hitting a wall or another vehicle.




The test method meant that passengers who weren't perfectly average were "out of position," in the vernacular of crash analysis. "If you are not a 50th-percentile male, something else happens," says Fariello. Something very bad, it turned out, happens to women and children. According to NHTSA's data, air bags killed 191 children from 1990 to 2009, as well as 39 women who were 5 ft. 2 in. (157 cm) or shorter.




"In the real world, crashes occur in all different directions, but we still need some standard test procedures to design around. The question is, What proportion of real-world crashes have you covered?" says Priya Prasad, a safety consultant and expert in injury biomechanics who was formerly Ford's top safety scientist. It would take several years of debate before NHTSA added a fifth-percentile female crash dummy to the test.




There's no question that air bags can and do save lives, especially in combination with advanced seat belts. But frontal-air-bag performance hasn't changed significantly in recent years, says Professor Richard Kent. He is deputy director of the Center for Applied Biomechanics at the University of Virginia, which does testing for the government and other institutions. The adoption of advanced air bags that depower in low-speed crashes, mandatory since 2006, and moving kids out of the front seat and into backseat restraints marked the last big survivability improvements. "As far as injury effectiveness, there's no reason to think it's substantially different than what it was five years ago," he says.




How Good Are Air Bags Anyway?




But the bottom line on air bags is that their contribution to an accident's survivability has always been incremental. Seat belts are the first and most important line of defense. Studies show that if you wear a seat belt, you have about a 45% greater chance of surviving a potentially lethal crash. Adding an air bag improves that figure to 50%, with a margin for error in both cases. According to NHTSA, frontal air bags saved 2,213 lives in 2012, but seat belts saved 12,174 lives, more than five times as many. Keep in mind that 33,561 highway deaths were recorded in 2012. If you crash at a high speed and aren't wearing a seat belt, having an air bag in the car is as useful as having a balloon.




Can air bags get better? "In my opinion, air-bag technology is mature. It has sort of done what it is supposed to do," says Kent. There's more promise in advances elsewhere. Electronic stability control, for instance, is reducing rollovers, which are particularly lethal. More advanced seat belts and sensors offer even more possibilities. By sensing the weight and position of occupants, and whether they are belted, belts work with air bags first to pretension (that is, tighten) the shoulder strap and then let it unspool to apply the minimum force needed to restrain passengers without injuring their ribs or thorax, with the air bag arriving to cushion the head. That's particularly important for the increasing number of older drivers, who suffer a disproportionate number of chest injuries.




It might be possible, says Prasad, to move to a smarter three-stage air-bag system. More likely, he says, is that black-box data recorders now in every car combined with newer anticollision warning and braking systems will improve the margin of safety. "You will be able to predict what type of crash. And once you start predicting, you could fire an air bag before the crash." Ultimately, self-driving cars may render the whole driver-safety issue moot. But that could take a decade or even two.




In the meantime, there are still a lot of old cars out there. Fariello recommends that you follow the New York State transportation department's advice and hold the wheel in the 9 and 3 o'clock position, as opposed to the 10 and 2 that many people were taught. If you are short, consider pedal extenders to keep your face at least 10 in. (25 cm) from the wheel. And as far as car sizes go, in a collision big beats small. Newton's laws won't have it any other way.




Fariello, Bloch and others are concerned that overweight people still face greater danger. Current testing hasn't accounted for them. According to Humanetics, a company that makes crash-test dummies, obese people are 78% more likely to die in crashes than average-weight people. The company is developing a test dummy that is 273 lb. (124 kg), with a body mass index of 35.




There is no precaution that protects you if your air bag becomes a weapon, as has happened in some of the Takata incidents. Bloch, a longtime advocate for safer air bags, believes carmakers should disclose the air-bag supplier for each model. Some inflate in a basketball shape, while others are pillow shaped, which is better. Some have tethers that limit the distance they can travel, which is potentially less damaging.




Amid all this sobering news, it's worth noting that the death rate on U.S. roads is declining—it has fallen 23% since 2005 and should decrease again this year—and seat-belt usage is at a record high. We're a lot safer—and will be even more so when the defective air bags are fixed.












[This article consists of 3 illustrations. Please see hardcopy of magazine or PDF.]








Sensors in your car detect the pulse of impact as well as the position of occupants, sending signals to the electronic control unit in the middle of the car. An algorithm decides whether to deploy the air bags and at what force—full or partial power.




























Air-bag inflators are small metal containers that hold an igniter and a propellant. In a crash, the ignited propellant triggers a chemical reaction that produces nitrogen gas, which fills the bag rapidly.












Takata's propellant, ammonium nitrate tablets, may be degrading over time, particularly in humid climates. This could cause a violent reaction in a crash, in which the force blasts apart the inflator, causing injuries or death.




8—14 M.P.H.




Minimum crash speed (13—23 km/h) that could cause an air bag to deploy








Lives saved by air bags in the U.S. in 2012












for an air bag to deploy








for the passenger to hit the air bag






Intro to Quality Week 2




Product Recall




Review the article “USPlabs Recalls OxyElite Pro Supplements Amid Links to Liver Illness” which can be found in your weekly reading. This article pertains to a recall of a popular health supplement. Assume you are the manager for the OxyElite Pro supplement. How can you use focus groups and surveys to determine your customer’s feelings about their products despite the recall that has occurred? Use your course materials and outside research to generate a solid analysis on why these methods would be helpful. Your analysis should be supported by research.








USPlabs Recalls OxyElite Pro




Supplements Amid Links




to Liver Illness




Dallas, TX-based USPlabs LLC has recalled




certain OxyElite Pro dietary supplement




products that the company markets after




receiving a letter from FDA stating that the




products have been linked to liver illnesses




and that there is a reasonable probability




that the products are adulterated.




The letter also notifi ed USPlabs that if




the company did not initiate a voluntary




recall, FDA could by law order the company




to immediately stop distributing the




products and immediately notify other




parties to stop distributing the supplements.




The action marks the second time




the FDA has exercised its recall authority




under the FDA Food Safety Modernization




Act (FSMA) by sending such a letter.




“We took this step to ensure that adulterated




and harmful products do not reach




the American public,” said Deputy Commissioner




for Foods and Veterinary Medicine




Michael Taylor. “We will continue to




work with our state, industry and regulatory




partners to prevent such products




from reaching the public.”




By letter dated Nov. 6, the FDA notifi ed




USPlabs about fi ndings indicating a link




between the use of several OxyElite Pro




products and a number of liver illnesses




reported in Hawaii. The FDA also noted




that cases of liver damage after use of these




OxyElite Pro products had been found in




a number of other states. In a review of 46




medical records submitted to the FDA by




the Hawaii Department of Health, the records




indicated that 27 patients, or 58%,




had taken a dietary supplement labeled as




OxyElite Pro prior to becoming ill. Seventeen




of the 27 patients (or 63%) reported




that OxyElite Pro was the only dietary




supplement they were taking. At least one




death has occurred among these patients,




and others required liver transplant.




In a warning letter issued to USPlabs




LLC on Oct. 11, 2013, the FDA informed




the company that OxyElite Pro and another




dietary supplement called VERSA-1




were deemed to be adulterated. The products




contained aegeline, a new dietary ingredient




(i.e., an ingredient not marketed




in the U.S. before Oct. 15, 1994) that lacks




“We will continue to work with our state,




industry and regulatory partners to prevent




such products from reaching the public.”




—Michael Taylor, FDA, on USPlabs recall




Global Sales of Non-GMO Food and




Beverages to Reach $800 Billion by 2017




Non-GMO products will account for about 15% of total




global food and beverage sales.




Global sales of non-GMO food and beverages are projected to rise




to $800 billion by 2017 at a compound annual growth rate (CAGR) of




15%, and will account for about 15% of total global food and beverage




sales at that point, according to Packaged Facts’ recently released




report, “Non-GMO Foods: Global Market Perspective.” Global




sales of non-GMO products reached $400 billion in 2012, accounting




for 8% of the overall global food and beverage sales of $5 trillion.




Excluding the U.S. and Canada, Packaged Facts identifi ed 10




countries that represent as much as two-thirds of the new global non-




GMO product introductions from 2009-2013. Russia is the leader with




15% share, followed by the U.K. with a share of 10%. From a comprehensive




global perspective, the U.S. share is roughly 40%. Aside from




the U.S. and Canada, Europe represents seven in 10 global non-GMO




food and beverage rollouts between 2009 and 2013. Europe is followed




at a considerable distance by Asia and Oceania.




Packaged Facts projected that non-GMO sales will increase in




all regions of the globe, as will the practice of labeling foods and




beverages with non-GMO verifi ed or certifi ed labels. Prompting




increases will be the inevitable expansion of GMO crops into territories




where they had previously been banned or limited. Concerned




shoppers will want GMO and non-GMO labeling to help




them distinguish between the two types of products. The BRIC




nations—Brazil, Russia, India and China—will be fertile territory for




non-GMO sales as their emerging middle classes look for healthier




eating options, according to David Sprinkle, research director for




Packaged Facts.




As other nations seek to clarify the labeling of their products,




both GMO and non-GMO, Packaged Facts projected the portion




of the global non-GMO market represented by sales in the U.S.




will decline through 2017. In addition, non-GMO labeling will become




more available as certifi ed testing operations, like NSF International,




join Cert ID in the non-GMO verifi cation market to take




advantage of a growing demand from marketers.




Non-GMO labeling will become more available as




certifi ed testing operations




join the verifi cation market.




16-31IndustryNews1213.indd 16 11/26/13 3:40 PM




Industry News




18 • Nutraceuticals World December 2013




a history of use or other evidence of safety.




The letter stated that failure to immediately




cease distribution of all dietary supplements




containing aegeline may result in




enforcement action.




U.S. Marshals Seize




Adulterated Supplements




Worth More Than $2 Million




At the request of FDA, U.S. Marshals




seized dietary supplements manufactured




and held by Hi-Tech Pharmaceuticals, Inc.,




located in Norcross, GA, after agency investigators




found the products contained




1, 3-Dimethylamylamine HCl (DMAA) or




its chemical equivalent in early November.




The retail value of the seized products is




more than $2 million.




A complaint fi led in the U.S. District




Court for the Northern District of Georgia




alleged that the products were adulterated




according to the Federal Food, Drug,




and Cosmetic Act because they contain




DMAA, an unapproved food additive that




is deemed unsafe under the law.




DMAA can elevate blood pressure and




could lead to cardiovascular problems, including




heart attack, shortness of breath




and tightening of the chest. Given the




known biological activity of DMAA, the




ingredient may be particularly dangerous




when used with caffeine. The FDA has




warned consumers about the health risks




of DMAA on its website.




On Nov. 12, U.S. Marshals seized more




than 1,500 cases of fi nished goods and




more than 1,200 pounds of in-process/raw




material goods from the Hi-Tech Pharmaceuticals,




Inc. facility.




“This company has a responsibility to




ensure its products are safe for distribution




and human consumption,” said Melinda




Plaisier, the FDA’s associate commissioner




for regulatory affairs. “We have taken action




to protect consumers and demon-




Trade Groups Defend Supplement Use




Following Multivitamin Review




Meta-analysis concludes more research needed on use of




vitamin/mineral supplements for CVD and cancer prevention.




A systematic review of published studies




found insuffi cient evidence that vitamin and




mineral supplements are effective for preventing




cardiovascular disease (CVD), cancer




or mortality from those diseases in healthy




adults, according to an article published in




Annals of Internal Medicine.




Two studies included in the review found




lower overall cancer incidence in men who




took a multivitamin for more than 10 years.




Those same studies showed no cancer protection benefi t for women.




Researchers cautioned that more research is needed before it




can be determined whether or not multivitamin supplementation




is benefi cial.




The evidence review was conducted by researchers for the U.S.




Preventive Services Task Force (USPSTF) to update its previous recommendation.




In 2003, the USPSTF found insuffi cient evidence to




recommend for or against the use of vitamins A, C and E, multivitamins




with folic acid or antioxidant combinations for the prevention




of CVD or cancer. At the time, the USPSTF recommended against




beta-carotene supplements alone or in combination with other supplements




because they had no benefi t and actually harmed patients




at risk for lung cancer. The current research review reconfi rmed the




beta-carotene fi ndings and also found good evidence that vitamin E




does not protect against cancer or cardiovascular disease.




In response to the review, industry trade associations offered




their analysis.




“Cancer is a complex disease, and the fact that there is even




some, albeit limited, evidence that a simple multivitamin could




prevent cancer demonstrates promise and should give consumers




added incentive to keep taking their multivitamins,” said Duffy




MacKay, ND, vice president, scientifi c and regulatory affairs, Council




for Responsible Nutrition (CRN), Washington, D.C. “We believe




the paucity of clinical trial evidence should not be misinterpreted as




a lack of benefi t for the multivitamin. We know for sure that multivitamins




can fi ll nutrient gaps, and as so many people are not even




reaching the recommended dietary allowances for many nutrients,




that’s reason enough to add an affordable




and convenient multivitamin to their diets.




“Further, given the encouraging results




from the Physicians’ Health Study (PHS) II




(Gaziano et al, 2012)—the study referenced in




this report as demonstrating benefi t for multivitamins




and cancer risk in men—academics




and government, as well as our own industry,




should continue to support and fund research




to clarify this relationship and to determine additional




benefi ts for vitamins and other dietary supplements.




Cara Welch, PhD, senior vice president of scientifi c and regulatory




affairs, noted the scope of this recent research has its limitations.




“The meta-analysis focused on studies that researched




generally healthy people, avoiding any instances for targeted




use of nutrients. Additionally, the researchers only concentrated




on studies with vitamins and mineral supplements as the primary




source of prevention. Multivitamin supplements should not




be expected, without the combination of a healthy lifestyle, to




prevent chronic disease. The results of this review should not




lead to widespread concern among consumers who take vitamin




and mineral supplements.”




John Shaw, executive director, NPA, added, “Dietary supplements




are used by more than 150 million Americans on a daily




basis. Research has shown that when taken in combination with




other healthy lifestyle practices, such as consuming a wholesome




diet and exercising regularly, people can benefi t from dietary supplements.




Consumers should be comfortable following a variety of




healthy habits, which includes supplementation. As always, NPA




encourages consumers to speak with their healthcare professionals




regarding their dietary supplement regimen.”




More than 150 million Americans use dietary




supplements on a daily basis.




16-31IndustryNews1213.indd 18 11/26/13 3:40 PM




Copyright of Nutraceuticals World is the property of Rodman Publishing and its content may




not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's




express written permission. However, users may print, download, or email articles for




individual use.








The requirements below must be met for your paper to be accepted and graded:




•Write between 750 – 1,250 words (approximately 3 – 5 pages) using Microsoft Word in APA style, see example below.




•Use font size 12 and 1” margins.




•Include cover page and reference page.




•At least 80% of your paper must be original content/writing.




•No more than 20% of your content/information may come from references.




•Use at least three references from outside the course material, one reference must be from EBSCOhost. Text book, lectures, and other materials in the course may be used, but are not counted toward the three reference requirement.




•Cite all reference material (data, dates, graphs, quotes, paraphrased words, values, etc.) in the paper and list on a reference page in APA style.


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