[PDF] - Day of Wood Randall Goodden Manufacturing Background Interim PDF Document

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1 Product Safety, Recalls & Product Liability Prevention Seminar

Day of Wood

Randall Goodden

Interim President
Corporate VP -

New Product Development, Quality & Product Reliability, Field Services, Technical Support, Litigation Management 30+yrs

Manufacturing Background

Available through

Amazon.com & Bookstores Everywhere

Author

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Seminars Worldwide

USA, UK, Europe, Malaysia, Australia, Thailand, India, China

In-House Seminars Product Safety & Liability Prevention Consultation

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IMPACT OF PRODUCT LIABILITY LAWSUITS

On Manufacturers

Over 80,000 product liability cases annually in the U.S.

(2013 study by Harvard Law School)

U.S. Product Liability Statistics U.S. Product Liability Statistics Statistics

Jury awards hit new $billion highs, not seen in

more that a decade

Class action lawsuits have increased in the

past 10 years by over 1000%

The average median jury award in all product

lines of product liability cases is over $1.9M

Plaintiffs win 37-53% of product liability trials in

front of juries (Contingency basis)

Roughly 96% of cases settle out of court, but

there are indications that this is dropping

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Automotive Recall Trends

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100 200 300 400 500 600 700 800 900 1000 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014

Recalls

Year

NHTSA RECALLS

Uninfluenced

Influenced

FDA Recalls

2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015

4670 5338 4266 5585 5778 8065 9361 9288 9469 8044 8061 9178

RAPEX Recalls

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European Commission

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U.S. Consumer Product Recalls

309 346 393 282 359 402 467 472 563 465

100 200 300 400 500 600 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 13

CPSC Recalls

by Fiscal Year

100 200 300 400 500 600 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 359 402 467 472 563 465 449 410 439 373 387 386

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Why So Many Recalls? Why So Many Recalls?

Typical Causes

Defects in Design
Not complying with Regulatory

requirements

Defective components/materials
Defects in manufacture

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Biggest Furniture Recall in U.S. History Biggest Furniture Recall in U.S. History

IKEA

Recalling up to 29 million chests and drawers in the wake of the third child death in three years, Ikea USA president Lars Petersson described the recall as "unprecedented" It marks the largest furniture safety recall in American history, according to the Consumer Product Safety Commission (CSPC).

Mechanical Design Failures Mechanical Design Failures

Fuji Recalls Over 10,000 Women’s Bikes

The bicycle's frame can break in the center of the downtube during use, causing the rider to lose control and fall.

Troy-Bilt Recalls 134,000 Electric Leaf Blowers

The leaf blower's impeller can break and strike the

perator during use, posing a serious laceration
hazard. 17 reported incidents, 12 required stitches.

159,000 Black & Decker Coffee Pots

Being recalled because their handles can break off and cause serious injury and/or burns.

Graco Recalls 4.7 Million Strollers

The folding hinge can cause the amputation of a child’s finger.

Electrical System Failures Electrical System Failures

GE and 12 Other Brand Dehumidifiers

Gree manufacturing (China) - 2.5 million dehumidifiers are being recalled because they can overheat, smoke and catch fire. Over 75 fires have been reported.

Kaz Portable Electric Heaters

The heater’s internal housing, including the fan, heating element, and circuitry, can detach and start on fire.

Genie Garage Door Openers

Genie is recalling 18,000 electric garage door openers because the control board can overheat and start on fire

GE Front-Load Washers

A wire can break in the machine and make contact with a metal part on the washtub while the machine is

perating, posing fire and shock hazard.

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Regulatory Failures Regulatory Failures

Womens Robes at Bloomingdales

The bathrobes fail to meet the federal flammability standard.

Scope Original Mouthwash

The mouthwash contains ethyl alcohol and bottles have malfunctioning child-resistant closures.

Triple Eight Bicycle Helmets

Product testing shows that the helmets do not comply with CPSC safety standards for impact testing.

JD Fine & Co Children’s Hooded Sweatshirts

The sweatshirts have draw strings at the neck.

The UL Global ‘Product Mindset’ Study The UL Global ‘Product Mindset’ Study

UL conducted a study of 1521 manufacturers and 1528 consumers across a range of export/import markets, including China, Germany, Brazil , India and the U.S. and found the following:

90% of manufacturers are confident that they are ahead of the

curve in delivering safety, reliability and sustainability.

70% of consumers feel manufacturers do not conduct thorough

testing before launching new products.

84% of manufacturers believe that consumer confidence in

product safety is increasing, but 58% of consumers believe that manufacturers value sales over product safety.

Product safety and performance are the top two considerations

for both consumers and manufacturers.

Why Focus

n

PRODUCT LIABILITY PREVENTION?

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Why Focus More On Product Liability Prevention?

Companies with the best Quality programs

aren’t doing enough. Quality systems are typically focused on preventing “Manufacturing Defects”.

Executive Staffs truly know little about

product liability prevention.

Studies show 75% of Engineers have no

real training in hazards & risk assessment.

In most cases, no one is truly in charge of

this area.

Recalls and product liability lawsuits continue

to grow in number

Product Liability Prevention

Understanding the full realm of

Accident Investigation Contracts & Agreements Design Reviews Reliability Testing Marketing / Advertising Labels & Instructions Recall Procedures Supplier Control Records Retention Incident Reports Manufacturing Quality

PRODUCT LIABILITY PREVENTION

Document Control Product Safety Reviews

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Accident Investigation Contracts & Agreements Reliability Testing Marketing / Advertising Labels & Instructions Recall Procedures Supplier Control Records Retention Incident Reports Manufacturing Quality

PRODUCT LIABILITY PREVENTION

Document Control Product Safety Reviews

Design Reviews

Accident Investigation Contracts & Agreements Design Reviews Reliability Testing Marketing / Advertising Labels & Instructions Recall Procedures Supplier Control Records Retention Incident Reports Manufacturing Quality

PRODUCT LIABILITY PREVENTION

Document Control

Product Safety Reviews

Accident Investigation Contracts & Agreements Design Reviews Reliability Testing Labels & Instructions Recall Procedures Supplier Control Records Retention Incident Reports Manufacturing Quality

PRODUCT LIABILITY PREVENTION

Document Control Product Safety Reviews

Marketing / Advertising

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10 Defects in Marketing

Accident Investigation Contracts & Agreements Design Reviews Marketing / Advertising Labels & Instruction Recall Procedures Supplier Control Records Retention Incident Reports Manufacturing Quality

PRODUCT LIABILITY PREVENTION

Document Control Product Safety Reviews

Reliability Testing

Accident Investigation Contracts & Agreements Design Reviews Reliability Testing Marketing / Advertising Recall Procedures Supplier Control Records Retention Incident Reports Manufacturing Quality

PRODUCT LIABILITY PREVENTION

Document Control Product Safety Reviews

Labels & Instructions

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Accident Investigation Contracts & Agreements Design Reviews Reliability Testing Marketing / Advertising Labels & Instructions Recall Procedures Records Retention Incident Reports Manufacturing Quality

PRODUCT LIABILITY PREVENTION

Document Control Product Safety Reviews

Supplier Control

Accident Investigation Contracts & Agreements Design Reviews Reliability Testing Marketing / Advertising Labels & Instructions Supplier Control Records Retention Incident Reports Manufacturing Quality

PRODUCT LIABILITY PREVENTION

Document Control Product Safety Reviews

Recall Procedures

Accident Investigation Contracts & Agreements Design Reviews Reliability Testing Marketing / Advertising Labels & Instruction Recall Procedures Supplier Control Records Retention Manufacturing Quality

PRODUCT LIABILITY PREVENTION

Document Control Product Safety Reviews

Incident Reports

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Akio Toyoda

President & CEO

Yoshimi Inaba

N.A. President & CEO

Akio Toyoda Testifies in Front of Congress Feb 2010

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More interested in growth, then

Quality & Safety

Failed to “connect the dots” as

incidents were surfacing in Europe and the U.S.

Blamed the customer for the

incidents

Failed to recall or react to the

problems when they learned about them

Akio Toyoda Testifies in Front of Congress Feb 2010

In 2013 Akio Toyoda began to reorganize the company in the aftermath of its struggles over the past few years. He made Jim Lentz, President and CEO Toyota Motor Sales, USA

Contracts & Agreements Design Reviews Reliability Testing Marketing / Advertising Labels & Instructions Recall Procedures Supplier Control Records Retention Incident Reports Manufacturing Quality

PRODUCT LIABILITY PREVENTION

Document Control Product Safety Reviews

Accident Investigation

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Review Review

More than just Hazards Analysis or

Warning Labels

More than just an Engineering

concern A wide spectrum of concerns that needs to be understood by the entire management team.

Typical Areas Where Companies Fail With New Products Typical Areas Where Companies Fail With New Products

Safety/failure analysis, if done at all, is

commonly based on ‘anticipated use’ as

pposed to ‘foreseeable misuse’.
New products aren’t tested thoroughly enough,

and/or companies aren’t reacting properly to test results.

Specifications are established with suppliers,

but not controlled or routinely monitored.

Field failures aren’t being closely monitored and

reacted to.

NEW PRODUCT DEVELOPMENT

The Role of the Design Review Team

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The Design Review Stage

Most important first stage in a products

lifecycle.

Least expensive time to make a change.
Viewed by the Legal community as an

industry standard.

REVIEW TEAMS / OBJECTIVES

DESIGN REVIEW TEAM PRODUCT SAFETY TEAM

 MANUFACTUREABILITY  COMPLIES WITH MANDATORY STDS  PRODUCT RELIABILITY  POTENTIAL HAZARDS  MAT’L / COMPONENT CONCERNS  NEEDED WARNINGS  INDUSTRY STANDARDS  SAFEGUARDS / SAFETY DEVICES  USER OPERATIONAL CONCERNS  POTENTIAL MISUSE  FIELD SERVICEABILITY  OPERATING INSTRUCTIONS

The Review Teams & Objectives

Need to have the right parties present

 Sales/Account Management  Mfg Engineering  Process Engineering  Manufacturing  Purchasing  Product Engineering  Quality / Reliability  (Component Parts Suppliers)

Design Reviews

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Design Review Team

The participants need to know their roles and responsibilities, it isn’t to just gain the knowledge of a newly proposed product. This is a technical critique of the product and process to make the product.

Design Reviews

Objectives

Understand the intended product
Understand the application, market
Evaluate proposed materials
Evaluate proposed processes
Determine manufacturability
Determine usability/serviceability
Test design reliability

Design Reviews Reliability Testing

Test to ensure the final product will withstand what it may be subjected to and perform in a reliable manner.

Office Depot Recalls 1.4 Million Chairs Due To Fall Hazard The chair’s seat plate weld can crack or break which causes the seat to separate from its base. Office Depot has received 25 reports of injuries suffered by consumers—including a fractured back and hip, injuries to the back of the head, and bruises and scrapes. The Office Depot Gibson Leather Task Chairs were made by companies based in Taiwan and China, and were sold at Office Depot stores and online from 2003 to 2012 for about $40..

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Objectives

Develop product reliability test plans,

design validation

Establish manufacturing inspection/test

plans and check points

Alpha and Beta test plans

Design Reviews

Documentation

What concerns were discussed?
What was decided?
What is the action plan?
Who has what responsibilities?
Timing
Assure any loopholes are closed

Design Reviews Design Reviews

HAZARDS ANALYSIS RISK ASSESSMENTS

The Role of the Product Safety Team

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REVIEW TEAMS / OBJECTIVES

DESIGN REVIEW TEAM PRODUCT SAFETY TEAM

 MANUFACTUREABILITY  COMPLIES WITH MANDATORY STDS  PRODUCT RELIABILITY  POTENTIAL HAZARDS  MAT’L / COMPONENT CONCERNS  NEEDED WARNINGS  INDUSTRY STANDARDS  SAFEGUARDS / SAFETY DEVICES  USER OPERATIONAL CONCERNS  POTENTIAL MISUSE  FIELD SERVICEABILITY  OPERATING INSTRUCTIONS

The Review Teams & Objectives Court Cases

Class Action v. Sears

(Dec 2007)

Sears Roebuck & Co., the nation's largest retail outlet for stoves, is sued in a class action suit for failure to put anti-tip brackets on all free-standing

r slide-in stoves or ranges purchased in their stores during the past

seven years. Stoves and ranges are turning over when extra weight is placed on an

pen oven door or storage drawer. At least 84 injuries and 33 deaths due

to range tipovers were reported to the CPSC, almost all involving very young children or senior citizens. About 5.7 million appliances were involved. Sears settled the class action lawsuit in 2008 for $546 million.

Court Cases

Class Action v. Sears

(Dec 2007)

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Objectives of the Analysis

Consider all possible hazards, including estimates
f probability of occurrences and seriousness of

resulting harm

Consider alternative design features or safety

devises, including appropriate warnings and instructions, that can be expected to effectively reduce or eliminate the hazards

Furniture Tip-Over Accidents

According to the CPSC over 43,000 injuries a year One child dies every 2 weeks

Definitions

Hazard - a potential source of harm
Risk - probability of occurrence and the

severity of that harm

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19 The Risk Assessment Process

Risk Evaluation Process

IDENTIFY THE

HAZARDS

Nature of exposure Probability of occurrence of hazardous event Possibility of avoiding or limiting the harm DETERMINE THE

SEVERITY

OF THE HARM

> X

PROBABILITY OF OCCURENCE

Risk Factors

Hazard Scenarios - how an accident might

happen

Level of risk from different hazards
Effect of countermeasures on risk, cost, and

performance

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The Manufacturer on Trial

Plaintiff’s Allegations - Manufacturer failed to provide adequate warnings or directions concerning the dangers or hazards.

The Manufacturer on Trial

Plaintiff’s Allegations - Product was defective in design and unreasonably dangerous for the marketplace

The Manufacturer on Trial

As the manufacturer, you must be able to

show the court that you addressed every reasonable concern.

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Design Reviews

We need to get a lot better at holding Design Reviews, creating the Teams, and training them for their roles.

Indicators of Trouble Indicators of Trouble

In many cases, before a defective product actually injures someone or causes property damage, “flags” will begin to appear indicating the potential for such an incident. But is anyone paying attention?

Customer Service

Warning Flags Warning Flags

The primary role of Customer Service is to “take care of the customer”, sometimes regardless of what may have happened with the product.

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Incident Reports

Are incidents of unusual product failure in the field forwarded to the right people?

 Can Sales, Account Management and Tech Support

recognize potential product liability failures from everyday failures?

 Is there a procedure in place telling who such information

should be taken to?

 Does someone monitor the nature and extent of warranty

returns, field failures, customer service calls?