MADAM CASTER Quality Management Week 2 and 3 Re-doAnswers 1Bids 1Other questions 10

Intro to Quality Management Week 3     Air Bag Recall   Assignment   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.   Article   Section:    Features   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.   HOW AIR BAGS WORK   THEY DEPLOY ONLY IN CERTAIN CRASH CONDITIONS. DEFECTS CAN HARM THE VEHICLE’S OCCUPANTS   [This article consists of 3 illustrations. Please see hardcopy of magazine or PDF.]   IMPACT   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.   PROPELLANT   STEERING COLUMN   FOLDED AIR BAG   IGNITER   INFLATOR   DEPLOYMENT   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.   NITROGEN GAS   WHAT GOES WRONG   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   2,213   Lives saved by air bags in the U.S. in 2012   AFTER A CRASH, IT TAKES:   0.02 SECONDS   for an air bag to deploy   0.06 SECONDS   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.   READING   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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