Intro to Quality Management Week 3Air Bag Recall.docx

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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•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
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