MADAM CASTER Quality Management Week 2 and 3 Re-do

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 www.nutraceuticalsworld.com 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

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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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