Summer/Fall Edition 2008

President's Message
From the Editor's Desk

ICPHSO News

Coming Events
Special Articles

 

PRESIDENT'S MESSAGE

One of the pleasures of serving as President of an organization like ICPHSO is working with the many devoted volunteers who run our seminars, our symposiums and our committees. The recent Midwest Training Session in Chicago is a case in point. Joan Mattson, Carol Pollack-Nelson and Marc Schoem put together an outstanding program on the issues of the day, including new state legislation mandating standards for lead in children’s products, possible certification programs for toys and the scope of the pending federal legislation, to name but a few of the many topics covered. Our thanks go to Joan, Carol and Marc for volunteering their time and energy for this session.

Volunteerism is an integral part of the fabric of ICPHSO. Board members donate their time for Board meetings and more menial tasks such as “bag stuffing” at our symposiums. Committee chairs donate their time for updating our Web site, designing our new membership program, obtaining sponsorships and setting up symposiums, training sessions and international meetings. If you are a member of ICPHSO and would like to get more involved, please contact me. We are looking for more committed volunteers to serve on our committees. I would also note that most of our Board members were significantly involved with one or more committees prior to being asked to run for the Board. So service on the committees is a likely path to leadership in the organization.

If you are not a member of ICPHSO, I would encourage you to join now. Membership is only $300 a year for business membership and $100 for non business membership. The application for membership can be downloaded at www.icphso.org/pdf/membershipApplication.pdf.

In closing, thanks to all of the volunteers who have come forward to help this year. You make ICPHSO the great organization that it is!

David H. Baker
ICPHSO President

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FROM THE EDITOR'S DESK

Sponsors—the lifeblood of the organization? I think so. Other than the fees we collect from conference registrations, the money we receive from our sponsors is our number one income. If my memory serves me right, symposium sponsorship money has increased from $1,500 to over $80,000 in 2008.

As a not-for-profit organization, ICPHSO will never be a wealthy organization—nor do we ever want to be. Our sponsors make it possible to keep our registration fees reasonable while not charging for meals at our conferences. In addition, sponsorship funds help us to diversify our attendance with consumers and researchers.

I do have a concern. Many of our sponsors have been very loyal, consistently investing sponsorship funds into ICPHSO. My concern is that with our current 3 meetings a year set up (Annual USA Meeting, International Meeting, and Training Meeting) we may be going to the well too often. I hope not and I am sure if sponsorship funds are reduced we will have the answer.

In the meantime we will continue to thank and recognize sponsors in as many ways as possible.

And to those industries/organizations that have not sponsored at ICPHSO—come join us. Our sponsors have the unique opportunity to promote themselves before all the key players in products, and our Annual Conference is recognized as the pre-eminent event for consumer product safety professionals.

Ross Koeser
Executive Director, ICPHSO

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COMING EVENTS

International Electrical Product Safety Conference Sept. 8-9, 2008

The International Electrical Product Safety Conference 2008, organized by the Electrical Safety Council, aims to address the current big issues in consumer product safety. Over two days, through a mix of plenary and interactive themed breakout sessions, the conference will embrace the economic, legislative and global aspects of consumer product safety by
tackling:

  • The safety of imported goods
  • The revision of the New Approach and the Low Voltage Directive
  • Ongoing initiatives in market surveillance
  • Counterfeiting
  • Protecting vulnerable consumers

The conference will be held at Church House, Westminster, London, a building steeped in tradition and positioned behind Westminster Abbey.

For more information or to book please visit: www.escconference.org.uk or call +44 (0) 207-880-6214.

20th Annual Product Liability Conference Course September 9-11,
2008, Madison, WI

The Role of Warnings and Instructions November 5-7, 2008, Madison, WI

The University of Wisconsin-Madison is a leader in product safety and liability prevention programming. For more than 30 years we have been providing engineers and product safety personnel with critical information on a wide range of topics.

For information on upcoming courses, contact Jeff Oelke, program director, toll free 800-462-0876, 608-604-9464 direct, or email joelke@wisc.edu. Or check our Web site at:
epd.engr.wisc.edu/catalogs/design.lasso.


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ICPHSO NEWS

  1. ICPHSO Holds Successful Training Program
  2. Membership in ICPHSO
  3. ICPHSO Meeting at Brussels Again
  4. COPOLCO Seeks Input from ICPHSO Members by Aug. 15, 2008

1. ICPHSO Holds Successful Training Program

On May 29, 2008, ICPHSO held a one-day intensive training effort providing industry and all other participants with the most current information on Consumer Product Safety Commission (CPSC) product recalls, practices and procedures, engineering and human factors considerations in the safe design of consumer products and the latest consumer product safety legislative proposals.

As David H. Baker stated in his introduction to the training, "You would have to have come down from Mars yesterday not to know that consumer product safety has suddenly become a very hot issue. You know an issue is hot when the Chicago Tribune, the Washington Post, the New York Times and the Wall Street Journal are all assigning reporters to an issue. It is with some irony that we are meeting here in Chicago today, as much of the brouhaha about product safety started right here with the Chicago Tribune's Pulitzer Prize-winning articles (from last summer) on various toy products.

The media onslaught then, not surprisingly, led to interest from the U.S. Congress and many state legislatures. As of today, May 29, 2008, there is a Conference version of a new comprehensive federal product safety bill about to head to President Bush for signature and several new state laws imposing restrictions on lead, cadmium and phthalates in children's products, including laws becoming effective on January 1, 2009, in California and effective on July 1, 2009, in Washington State. There are over 200 bills introduced in over 30 states pertaining to product safety, with the likelihood that several other laws will be enacted in 2008."

The training was attended by 182 people who not only evaluated the training as outstanding, but enjoyed the beautiful campus at McDonald's Corporation in Oak Brook, Illinois.

Ninety-six (96%) percent of those who evaluated the training stated that the training workshop met their expectation and 96% would recommend the workshop to others in their field.

Here are some of the attendees' comments:

"Great information—the question/answer during each breakout session was great. I'm new to this field, so it was very helpful to hear issues and questions from other companies."

"Hearing about upcoming legislation, including Federal, directly from CPSC."

"It was a serious high-level conference with people who are leaders in their field. It was very useful and helpful to get a better idea of these individuals and organizations' opinions, ideas and viewpoint on where we are heading in this area in the U.S.A."

"It was all valuable information for me. There are many different speakers from all different backgrounds which really gives many different perspectives. I like the way the information is put out there and then there is a question/answer session. The networking is great as well."

"Networking with the participants who came from such a wide range of government/industry."

"Venue was wonderful. Being in a lecture hall was much better than in the hotel conference rooms. Easy access to drinks. Plenty of garbage cans. Very easy to view speakers."

The International Consumer Product Health and Safety Organization is
grateful and wishes to thank the sponsors of this training. The sponsors are:

McDonald's Corporation
Bureau Veritas Consumer Products Services
Intertek Testing Services
Product Safety Letter

Finally, it is important to thank our host organization/sponsor McDonald's Corporation. The meeting was held at Hamburger University, which is an outstanding facility for training. We utilized all three auditoriums which included LCD, Screen, built-in podium, lavaliere microphones, sound system and laptop connection at the podium. This and more—all free. Thank you.


Don Mays and Michelle Reinen


Ross Koeser and Joan Mattson

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2. Membership in ICPHSO

For the past 15 years, membership in ICPHSO was loosely defined as attending the most recent ICPHSO Annual Meeting. This will all change in August of 2008.

The ICPHSO Board of Directors voted to make ICPHSO a true membership organization including annual dues.

"You can help ICPHSO continue its mission of addressing consumer product health and safety issues by becoming a member. Memberships are available at several levels, and all levels of membership enjoy benefits such as: discounted conference rates, opportunities to network via our membership directory which is available to members only, and online access to presentations made by highly respected health and safety professionals."

The membership categories, benefits, and pricing information (dues) can be found by clicking here.

If you have any questions about membership in ICPHSO, contact our Membership Department at (414) 908-4930, Ext. 116 or by e-mail: icphso_membership@icphso.org.

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3. ICPHSO Meeting at Brussels Again

ICPHSO is returning to Brussels, and the dates are November 18 and 19, 2008. The ICPHSO meeting will once again take place as part of an international product safety week hosted by the European Commission.

Details of the meeting including the Agenda and how to register can be found on the ICPHSO Web site at www.icphso.org.

A brief listing of agenda topics follows:

  • Regulator Perspectives on Consumer Product Safety
  • Regulatory Perspectives on Emerging Issues
  • Stakeholders Perspectives on Emerging Issues
  • The Nano Challenge: Understanding and Managing Nanotechnology Opportunities and Safety Risks
  • Investment in Quality Management
  • Counterfeiting
  • Environmental and Health Aspects of Product Safety
  • Age Grading and Labeling
  • The European Product Safety System and the Supply Chain
  • Recalls Under the European Product Safety System

This is a must-attend meeting that will attract a large number of product safety representatives from many countries. Your networking possibilities will be excellent——both from industry and the regulatory governments.

Sponsorship opportunities are still available. Please contact Susan Winter for more information. Her e-mail address is: Susan.Winter@csa.ca.

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4. COPOLCO Seeks Input from ICPHSO Members by Aug. 15, 2008

Please note that COPOLCO (Consumer Policy Committee) is a part of ISO (International Standards Organization) and that a previous working group on Product Recall also received valuable feedback from ICPHSO and we look forward to continuing this relationship.

Please complete and return the questionnaire by August 15, 2008 to the attention of Robert Duncombe, rodu08@gmail.com. We thank you in advance for your assistance.


Questionnaire
Adequacy of Instructions on Product Assembly, Maintenance and Usage

The issue of adequacy of instructions was initially raised in the USA at ASTM and by Health Canada at a fringe meeting regarding product safety. Also the Consumer Producty Safety Commission (CPSC), USA raised the issue with respect to assembly instructions for bed rails and installation instructions for car seats. The work at ASTM was related to the development of design guidelines to be included in an annex to the Standard to minimize the possibility of a consumer incorrectly assembling a product, and thus creating a potential safety hazard.

The Working Group on Consumer Product Safety at the COPOLCO meeting in May 2007 thought that this may be a wider problem involving instructions on assembly, maintenance and usage for many consumer products. There was a general agreement at COPOLCO in May 2007 that this issue needed to be addressed and a Working Sub-group has been set up to study and determine what, if anything, has already been done to address this issue, and to recommend to COPOLCO what, if any, actions regarding guidelines or standards to pursue.

Accordingly, COPOLCO Resolution 15/2007 was adopted and tasked the Working Group on Product Safety to investigate the adequacy of instructions as they pertain to assembly, maintenance and usage, and requests this WG to report on the research at the 2008 COPOLCO Plenary meeting.

Under the auspices of Dr. Elizabeth Nielsen, Chair, WG on Consumer Product Safety – Canada, a sub-group was organized and participants nominated as follows:

Elizabeth Nielsen - Canada
Ratna Devi – Standards Users – Malaysia
Robyn Easton – Federation of Australian Scientific & Technological Societies - Australia
Jay Jackson – Office of Consumer Affairs - Industry Canada
Srikanth Mangalam – Technical Standards and Safety Authority - Province of Ontario – Canada
Elizabeth Hanley – Standards Australia
Guillermo Zucal – Consumidores Argentina
Dana Kissinger – ISO COPOLCO - Switzerland
Robert Duncombe (Chair) – Quality Management Consultant - Switzerland

The objective of this questionnaire is to obtain your input about the relevancy of the issue outlined above; and, where possible, to obtain data and statistical evidence pertaining to the adequacy of instructions issue.


Name:

Organization:

Address:

Country:

E-mail address:

1) In your country, have any comments or reports of injuries related to the adequacy of instructions for consumer product assembly, maintenance and/or usage been received from -

Public authorities Yes No Don't know
Standards organizations Yes No Don't know
Consumer groups Yes No Don't know


2) If you answered yes to question 1, what comments or reports of injuries have been made? In particular, please elaborate where inadequate instructions have contributed to potentially unsafe or hazardous conditions.


3) The members of the COPOLCO Subgroup have identified several issues regarding the adequacy of instructions which are listed below. If the issue is relevant in your country, please include your comments, and where possible include data to support these comments.

  • Instructions for consumers and members of the general public need to be clear, concise, user friendly, user centric and avoid information overload.


  • Despite the availability of numerous international standards pertaining to the quality and readability of directions, instructions are often confusing or poorly written.


  • Instructions originally written in the language where the product is manufactured and subsequently translated into English, French or other languages may not be translated correctly. How could this be improved?


  • Should universally harmonized symbols and signs replace some written instructions?



  • Maintenance instructions may have different needs depending on the weather, particularly in countries where the climate may cause more rapid product deterioration. Is this need addressed today?


  • How can the problem of instructions being lost or discarded immediately after point of sale be addressed? There is a potential hazardous situation when ongoing maintenance is required. Also, there are often no instructions available for assembly and/or maintenance when goods are second hand.


  • Are there any regulatory requirements for instructions? If so, are these viewed as adequate, limited or contradictory to international best practices?


4) Should assembly, maintenance and usage instructions be mandatory for consumer products? Please explain the reasons for your answer to this question.


5) Do you have any further comments or issues that the subgroup should be considering?


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SPECIAL ARTICLES top

Nanotechnology and Its Impact on Consumers

Nanotechnology is one of the key emerging technologies of this century with the potential to profoundly affect all aspects of our lives by providing significant benefits in such areas as energy efficiency and pollution prevention, as well as enhancing the properties of consumer products, the safety of food and water, and the treatment of disease.

The Consumers Council of Canada has just released new research prepared by Dr. Elizabeth Nielsen on this emerging technology. Titled Nanotechnology and Its Impact on Consumers, the report explains for consumers what nanotechnology is, why the materials produced by the technology are different, what consumer products contain nanomaterials, what is known about the benefits and risks associated with the materials, what gaps exist in the scientific knowledge, what is being done by governments, industry and the standards community to manage the new technology, and the concerns and level of knowledge consumers have about this technology.

Although consumers do not think that government exercises adequate oversight over nanotechnology, they do not trust industry to regulate itself and believe that regulatory oversight is critical to managing the technology. The confidence of consumers in this new technology will in the end very much depend on the effectiveness of governments in providing oversight.

Nanoscale materials due to their small size, relatively larger surface area and a greater proportion of atoms on the surface can be more chemically reactive and exhibit very different electrical, physical, optical and/or magnetic properties than their larger counterparts. In addition, the nanomaterial may be more toxic and has the potential of dispersing readily through the body or the air, water and soil in the environment.

Nanomaterials are being used or being considered for use to improve a wide variety of consumer products because of their superior and novel properties. Currently, over 585 consumer products utilizing nanomaterials have been identified on the American market. The products include improved breast cancer therapies, stain-resistant clothes, prolonged shelf life of foods, self-cleaning window glass, transparent sunscreens, scratch-resistant car paint, teddy bears with anti-microbial properties, and lighter and stronger sports equipment Future applications of nanotechnology could possibly result in computers with increased speed and storage capacity, food packaging that warns of contaminated food, improved drug delivery, energy-efficient lighting, water purification devices, and matter to rebuild bones and nerves.

From the literature reviewed, it appears that any adverse impact on human health will be caused by the tiny scale of these materials, their increased reactivity, and their ability to penetrate the body by various routes and cross cell membranes. Exposure to nanomaterials can vary significantly depending on how the material is incorporated into a product and its behaviour over the lifecycle of the product. It is unlikely that many uses of nanomaterials in products intended for consumers will pose health or safety risks since the nanomaterials are encapsulated in table matrices and exposure is not anticipated (e.g. sports equipment or computers). Potential risks to human health will primarily be related to products where the nanomaterials exist in a free form and exposure is more likely (e.g. cosmetics, personal care products or cleaning products). It was also shown that the route of exposure can affect any adverse impact on humans. There is considerable uncertainty about the actual risk posed since limited information is available on the potential toxicity of nanomaterials and the actual exposure over the lifecycle of the product. The release of nanomaterials into the environment could occur potentially during manufacture, production, use, disposal or recycling of the nano-enhanced product, or as a result of direct release to clean-up the environment. There appears to be almost no scientific evidence available to evaluate the potential impact of nanomaterials on the environment or life in the environment. Questions about the behaviour of nanomaterials in air, water and soil, their persistence or accumulation in the environment, their unintentional release from disposed products, or the intentional release for remediation purposes have not been answered. The main research emphasis to date has been on the development and commercialization of the technology and not on it affects on human health or the environment. A number of significant gaps in key areas have been identified and include a lack of:

  • Definitions and nomenclature/classification systems;
  • Test procedures and instrumentation to measure, characterize and evaluate nanomaterials;
  • Identification of the potential impact of nanomaterials on the body at the cellular level, their toxicity and the resulting risks to human health;
  • Knowledge about the effect of nanomaterials on all types of biological

The main challenge facing society is how to realize the societal benefits while minimizing adverse impacts.

Copies of the report may be obtained from the Consumers Council of Canada. www.consumerscouncil.com or Dr. Elizabeth Nielsen at knielsen@magma.ca.

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KID’s TEST Program Gives Engineering Students Hands-on Design Safety Experience
By Kate Gulian, Program Associate, Kids In Danger

Kids In Danger (KID) works to keep children safe by improving children’s product safety. KID’s program, Teach Early Safety Testing (TEST), engages future engineers and works to spread an awareness of children’s product safety. TEST integrates knowledge about product safety into classroom settings where engineering students are assigned design projects. The goal is to promote innovative and safe ideas from the students as they tackle the individual design problems. Current projects by students illustrate KID’s important role in relaying information regarding design safety and testing measures.

KID collaborated this spring with Northwestern University to work with two student teams on projects. The students’ recent development of alternatives to dining booster seats and bathing devices reflect KID’s values and demonstrate the students’ knowledge and respect for design safety.

Booster chairs elevate children at tables while also keeping them securely in place. However, some designs have proven unsafe, as children fall off the booster or both the booster and the child fall off the chair. KID tasked a student team to create a booster chair that would provide maximum safety while elevating a 2- to 4-year-old child. The student team developed The Better Baby Booster. The booster consists of a single plastic molded seat with straps that fasten it securely to the chair. Additionally, in order to create a sturdy booster that adapts to many types of seating, the team adhered memory foam to the bottom of the mold as well as a layer of high-friction material. These features ensure the booster’s stability while allowing the child to sit comfortably and safely at the dinner table.

Similarly, the purpose of baby bath seats is to keep a child in place while a caregiver is bathing them. The device, meant for children between four and 10 months old, works to support the child. Unfortunately, a misconception among some caregivers is that they can leave a child in the device unattended. This false belief, as well as the poor functionality of some baby bath seats, has caused an alarming toll of deaths. Therefore, after consulting with TEST, a team of engineering students constructed The Seahorse, a harness system that connects the child to their caregiver.

The Seahorse differs greatly from the standard baby bath seat. The device includes a parent harness that supports the child’s weight and clips to the child’s harness. The device is washable, comfortable, and provides maximum access for bathing. More importantly, the design ensures that the caregiver remains close to the child during bath time and serves as a fun alternative to a child’s typical bathing experience.

KID’s TEST provides knowledge and educational opportunities for those interested in product design and engineering. It also offers a new lens through which students can view product design while simultaneously emphasizing the importance of testing products. Through collaboration with engineering programs, KID hopes to continue to influence a movement towards increased children’s product safety. For more information, visit kidsindanger.org/programs/test/index.asp or contact Nancy Cowles at nancy@kidsindanger.org.

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Avoiding and Managing Product Recalls
By Gene Grabowski and Jason L. Hertzberg

Consider this: the Consumer Product Safety Commission (CPSC) is demanding a product recall of your best-selling product due to a defect that poses a potential danger to consumers.

You must now ask yourself the following questions: Are our customers safe? How well are we prepared for a recall? How do we protect the brand? What impact will this have on our future? How badly will our stock get hit? What other risks does this present for our company?

According to CPSC, there were over 450 voluntary recalls announced during fiscal year 2006. Although it is difficult to quantify in terms of quantitative costs, recalls can result in irreparable damage to a company’s brand or reputation. It should come as no surprise, then, that recalls are becoming more frequent and are now a harsh reality in today’s business environment.

To avoid the costs, proactive companies are assembling the necessary resources to develop product recall prevention initiatives well before a potential crisis occurs. These programs are especially important in a global business environment; as more products are manufactured in different legal, business and regulatory environments, recalls have the potential to become even more commonplace in the future than they are today.

The components of a product recall prevention and management initiative may vary, but an effective approach should incorporate the following elements:

Think like a consumer.

In the Consumer Product Safety Act of 1972, the term ‘’consumer product’’ is defined as “any article, or component part thereof, produced or distributed (i) for sale to a consumer for use in or around a permanent or temporary household or residence, a school, in recreation, or otherwise, or (ii) for the personal use, consumption or enjoyment of a consumer in or around a permanent or temporary household or residence, a school, in recreation, or otherwise.” Therefore, independent of the nature of the product, designers and manufacturers of products are challenged to keep in mind how consumers think and how they might interact with the products, namely the aspect of product development associated with human factors. This aspect includes everything from the construction of the product to the instructions and warnings supplied with it.

Thus, questions such as “Are the supplied warnings and instructions clear?” or “How might they be interpreted or misinterpreted?” are relevant to those charged with designing or evaluating products. It is worth noting that the CPSC has taken the position that faulty product instructions, warnings or labels alone can constitute a product defect worthy of a recall, even if the actual product itself is not defective. Thinking like a consumer is a fundamentally important concept; incorporating this view in the design, construction and packaging processes can raise awareness of important human factors before the product ever reaches the consumer.

Determine how your products can fail and test them accordingly.

Risk analysis, a valuable exercise that can be used to help determine just how a product can fail, can take place in a variety of forms, including a failure modes and effects analysis, fault tree analysis, and event tree analysis. These are powerful tools, especially when they reflect the experience of seasoned designers and subject matter experts. After performing these types of analyses, a company can rank risks associated with the product and test them accordingly.

Problems can result from companies not performing comprehensive testing of their products before they are in their customers’ hands. In some cases, products can fail in a manner that was not anticipated and cause injury or death. One way to limit this possibility is to perform rigorous, well-planned tests during the product development stages, including tests that appropriately represent end-use conditions.

Various types of design validation tests can shed light into possible failure scenarios and resulting consequences. These include normal-use tests, in which the product is used in accordance with the instructions; misuse tests, in which the product is tested in ways that are reasonably foreseeable, (i.e., not precisely according to the instructions but in a manner that might be reasonably extrapolated from conventional use) in an effort to study the various outcomes; and abuse tests, whereby the product is purposely abused with an aggressive testing approach to see what might happen. While accelerating conditions might be applied to each of these test types, caution should be applied when selecting relevant conditions. In addition, forced-failure tests can be useful where, for example, specific components are rendered inoperable prior to testing to determine how the product will behave or fail under different scenarios. It is helpful to know what to anticipate if Murphy’s Law affects your product.

Consider having an independent party evaluate your product.

After internal testing has been completed, it can be extremely beneficial to have your product evaluated and tested by an independent party that possesses relevant engineering expertise relating to your product. In many cases, consumer products are evaluated by a certified testing laboratory in order to verify compliance with a voluntary or mandatory standard; however, these tests should be considered as a “minimum bar” to be met as they do not prove that the product is completely safe and will never be the subject of a product recall. In fact, testing to standards is not a substitute for product-specific, end-use testing. Testing conducted by an independent third party can be focused on those scenarios not covered by voluntary or mandatory standards and, perhaps, not considered during internal testing. It is easier and far less costly to understand how your product might fail during prototype or qualification testing in a laboratory than when in use in a consumer’s home.

Keep accurate and complete documentation and ensure that products are traceable.

Good records enhance the possibility of traceability if a problem occurs. The “fingerprint” of a product—including the manufacturing date, serial number, specific model, batch number and the manufacturing facility where it was assembled—can help narrow or define the extent of a problem and help clarify precisely which products might be affected. If an engineering-based argument can be made for why a product recall need only be conducted for a specific population, comprehensive documentation and product traceability can allow a company to put a fence around the problem and limit costs associated with a recall. You cannot limit the scope of a problem if you cannot confirm the problem’s boundaries.

Manage change very carefully.

In some cases, a safe product is produced with no problems for a period of time and then something about the product is changed—possibly a modification based on consumer feedback or a new component supplier is introduced, or a manufacturing process is slightly altered to increase efficiency or to conform to environmental regulations. Unfortunately, in some cases, solving one problem can lead to another. Even seemingly insignificant changes can have huge ramifications in the performance or safety of a product. If a change to a product is contemplated, performance tests that may be relevant to the change in order should be carefully considered and evaluated to determine the associated risks. For products without a historical risk analysis, this may be the time to update the files and revisit technical assumptions.

Remain focused on product safety in a changing global landscape.

Given the rapid pace of product innovation and technology evolution, shorter development times put pressure on companies to get products to market quicker than ever before. Additionally, the globalization of the manufacturing marketplace creates added pricing pressures, increasing the potential for jeopardizing quality and safety in the process.

For example, the most recent U.S. Census Bureau data show Chinese factories shipped $288 billion worth of goods to the United States in 2006. Virtual companies (those that out-source most aspects of a business) are particularly prone to quality and safety problems—and recalls—in part due to pressures from retailers and distributors to lower profit margins, thereby putting engineering and auditing functions at risk. In addition, as more products are outsourced and/or manufactured overseas, another layer of complexity is added to product development. It is not just the physical separation between corporate headquarters and factory floors, but language differences that can complicate operations and the ability to communicate effectively. Risk is best managed when lines of communication are well maintained and when product safety requirements are clearly stated and enforced.Build and refine a formalfeedback system.In order to be aware of safety issues in the marketplace, it is important that customer feedback reaches the right individuals in the company, including, ultimately, the operational management of the business. It is good practice to establish a formalized system for collecting and reviewing customer feedback, incident reports, complaints, customer letters and hotline calls.

This information, if properly collected and analyzed, will allow a company to spot trends and potential issues. The information should also be integrated with retailers’ and distributors’ systems so that manufacturers can get necessary feedback to identify potential problems quickly and determine if there are any safety-related issues that require action. Such information also provides valuable input into the design process for new products. Customer feedback is an extremely valuable resource for designing and refining well-made products.

Preparing for the worst-case scenario is always a good idea. For companies that find themselves having to conduct a product recall, managing the process typically begins with the following:

Develop an effective crisis communications plan.

The key to developing a good crisis communications plan is to create an interdisciplinary team that draws on expertise from every corner of the company, including the chief financial officer, marketing officers, engineering department and general counsel. It is a good idea to have an independent, unbiased perspective from individuals outside of the company on this team, as well, in order to avoid the “my baby” syndrome, where team members who have developed the product from cradle to market have a difficult time acknowledging a problem. The challenge in developing a crisis communication plan is determining the critical message(s) that need to be delivered to the public and doing so swiftly and clearly. With a clear message and a strong team, the crisis of a recall can be effectively managed.

Pick the right spokesperson.

If a product is investigated by the government or news media, some companies initially circle the wagons and become defensive and unresponsive because they believe that the crisis situation is nobody’s business but the firm’s. In fact, a product recall is one of the most “public” periods of time for a business.

To avoid a self-defensive posture, a company should consider putting itself in its consumers’ shoes, to gain a better understanding of how to protect consumers and perhaps even motivate them. During a crisis or a recall, the messenger is often inseparable from the message itself, so it is important to choose the most appropriate person to deliver your message. If a product is mainly purchased by mothers (e.g., diapers), consider having a mother speak about the issue.

Your messenger must speak to the outside world, not just to the media. In fact, it is critical to remember that the media is a conduit for reaching out to the consumer. Consumers want to see people who appear trustworthy and knowledgeable and can communicate effectively.

For example, in the crisis of 1982 involving poisoned Tylenol capsules, the CEO of Johnson & Johnson became the spokesperson, stepping up to “take the heat” and to interface with the public. Since the company did not know the source of the poison, it decided to remove all products from stores, sacrificing short-term profits, but building trust with the public that would last for decades. The case, still studied years later, has become a gold standard for how to conduct a recall.

While the preceding concepts are not meant to be comprehensive, they are important points for a company to consider when addressing product safety. The more energy directed towards product development and implementing corporate systems geared towards product safety, the less likely a costly product recall crisis is to occur.

Gene Grabowski, vice president of Washington, D. C.-based Levick Strategic Communications, is a crisis communications counselor specializing in product recall and liability issues for law firms, Fortune 500 companies, trade associations and government agencies.

Jason L. Hertzberg, Ph.D., P.E., is a principal engineer at Exponent and the director of the Chicago office. He provides technical expertise in the areas of product recall and CPSC related issues, product liability, and support for a wide variety of industries ranging from consumer products to medical devices.

Reprinted with permission from Risk Management Magazine, November 2007 issue, pages 12-17. Copyright 2007 Risk and Insurance Management Society, Inc. All Rights Reserved. www.rmmag.com

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Manufacturers versus Component Part and Raw Material Suppliers: How to Prevent Liability
By Kenneth Ross

Introduction

One of the more perplexing and potentially dangerous areas of product liability practice and law concerns the liability of the original equipment or finished product manufacturer (“OEM”) versus the liability of component part and raw material suppliers.

The plaintiff will always sue the OEM because the OEM’s name is on the product. However, determining liability is usually a complex analysis of the actions and inactions of everyone in the chain of production and distribution. In many situations, the OEM believes that the accident could have been caused by one or more of its suppliers. As a result, the plaintiff or even the OEM may ultimately sue other parties in the chain of production.

Involving such suppliers in litigation significantly increases the cost of the litigation and can cause damaging evidence since the defendants will tend to point fingers at each other. These disputes are very factually intensive and cannot easily be resolved early in the case. As a result, manufacturers of finished products and their suppliers need to consider the law and the ways in which they can minimize the chance of accidents before the product is sold and how, if accidents occur, they and others in the chain of production can defend themselves.

Basic Law

The relevant statement of law from the Restatement of Torts (Third): Products Liability (1998) says that if the component is itself defective and the defect causes harm, then the supplier is liable. In addition, the supplier is liable if the seller substantially participates in the integration of the component into the design of the product and the integration of the component causes the product to be defective and the defect causes the harm. Restatement 3d, Section 5.

In both of these situations, it seems fair to hold the supplier responsible. However, many times, the comparable responsibility of various suppliers, the OEM, and possibly the distributor of the component or finished product, can make a fair apportionment very difficult.

Where the component is not defective and the supplier did not participate in the selection or integration of the component into the final product, the law applies several doctrines to hold the supplier not liable. They are called the “raw material supplier defense” and the “bulk sales/sophisticated purchaser rule.”

These rules, which affect the burden of proof and do not really act as true affirmative defenses, are based on the premise that the OEM is the expert in the design and manufacture of the finished product and is a “sophisticated purchaser” as opposed to a supplier who may or may not know how its component or material is being used.

Is the component defective?

It is difficult enough with final products to determine whether they are defective. With components, it can be even harder. Components can be designed for many applications. And, there are component parts and raw materials that have different levels of function.

Some components, such as switches, do not function unless integrated into other products. Other components, such as motors, can function on their own but still may be incorporated into another product. The law may treat these differently, especially when considering the knowledge of the various parties when selecting and installing the component.

Usually, the OEM selects the product from a catalog or after discussion with personnel from the component manufacturer or their distributor. If the OEM did not consult the component supplier and selected the wrong component for the application, the product is not itself defective and the component manufacturer should not be liable. However, the OEM can still blame the supplier who provided incorrect or unclear information in the catalog and that is why they selected the wrong product.

The component can itself have manufacturing and design defects and defects in warnings and instructions. Liability of the component manufacturer under these theories would be based on the same law as that for OEMs.

Raw materials can be defective if they are contaminated or have the wrong formulation. These are manufacturing defects. While raw materials cannot be defectively designed, the supplier can fail to warn. If the OEM or component supplier uses the wrong raw material, it may be because the raw material supplier did not warn against such use. In addition, the supplier may have failed to warn about some hazard involving the use of the raw material or failed to instruct about how to use the raw material in the manufacture of the component or product. Or, maybe the OEM didn’t ask and made certain assumptions or incorrect interpretations of sales literature or instructions.

On the other hand, the OEM or component supplier can fail to warn the user and, in that case, it may be their responsibility and not that of the raw material supplier. However, it may be the responsibility of the raw material supplier to warn or instruct the OEM or component supplier about any hazards that exist during foreseeable use of the component or final product made from the raw material.

One other area deals with incomplete products. Manufacturers of products such as machines which seem like finished products are not responsible for failing to incorporate certain safety features when they do not know what the machine is to be used for. In that case, the law considers them the manufacturer of an incomplete product, similar to that of a component manufacturer, and not liable for failure to provide a safe product. Instead, the employer is responsible under worker’s compensation law for providing the appropriate safety devices for the particular application and use. Of course, the OEM can still be sued in product liability, especially if they “substantially participate” in advising the employer about how to make the machine safe for its intended use.

Substantial participation

The component supplier can be liable if they are substantially involved in the integration of its component into a final product, and the integration causes a defect and harm. Of course, the OEM could also be responsible.

Determining substantial participation is a very difficult factual and legal issue. In addition, it places the various parties in a quandary when the product is being designed and manufactured. Under the law, the component or raw material supplier is “discouraged” from substantially participating in the selection or integration of their product into a finished product. This is not a desired result but certainly an understandable one. Unfortunately, that lack of participation may create a problem in the final product and result in incidents and lawsuits.

While the component supplier has an interest in having its products installed and used safely and correctly, it does not want to increase its potential liability by offering advice that may or may not be correct. Despite that, if there are any questions by the purchaser concerning selection, installation, use and maintenance of the component, the supplier should provide assistance if they feel competent to do so.

There is some case law that says that merely designing a component to a manufacturer’s specifications does not necessarily constitute substantial participation. Also, providing technical services or advice concerning the use of a component part does not, by itself, constitute substantial participation. However, if a jury believed the supplier knew or should have known of a problem with the OEM’s use of their component and didn’t say anything, then they may want to try to keep them in based on negligent omission rather than substantial participation.

Again, the possible fact scenarios are plentiful and can become very complex as the number of possible culpable parties increases. As these parties try to blame each other, the plaintiff’s attorney can sit back and have the defendants make his case.

Preventive Measures

From the supplier’s side, I think you want to deal with OEMs who seem to be careful about the selection of components and knowledgeable about the uses to which it will be subjected. If the OEM asks questions, it is incumbent on the supplier to be as helpful as they can be to assist the OEM in selecting the correct component and installing it correctly. While this will fall over the line into “substantial participation,” hopefully problems are minimized or prevented and the issue of who is liable never needs to be addressed.

The supplier also wants to deal with OEMs who know how to correctly install the component and OEMs who adequately warn and instruct the final product user or maintenance personnel on how to install, use, and maintain the final product and its components. Even if the supplier is innocent, it can be very expensive to convince a plaintiff, a judge, or a jury of that fact.

For OEMs, I think they should buy components and raw materials from suppliers who are willing to be of assistance to the extent it is necessary. If the supplier, usually on the advice of counsel, takes the position that it gives no advice other than what is contained in the sales literature, and the OEM makes the final decision, then maybe the OEM wants to go to another supplier. Whether to change suppliers should be based, in part, on the OEM’s comfort with making the final selection of the component.

In addition, the OEM wants to purchase from a supplier who manufactures the product correctly and in compliance with specifications and who supplies to the OEM all warnings and instructions necessary for the proper installation of the component and for the proper and safe installation, use and maintenance of the component.

In the post-sale area, OEMs want to be sure that the suppliers will inform the OEM if there are any problems with the component or raw material as used by other customers. And the supplier wants to confirm that the OEM has a good post-sale monitoring system and will quickly inform the supplier if there is a problem that is potentially being caused by the component.

If some problems do occur, the parties will need to reconstruct what advice was given by each party and what was the basis of that advice. Unfortunately, many times memories fade and documentation of the sale or design process is unclear, especially many years after design when most problems arise.

The best way for the respective parties to deal with this issue is to have clear and documented communications on what is being supplied, who selected the part, and what was the basis of the selection. If the component part supplier suggested the part, there should be documentation on what information was used by the supplier to make the recommendation. Similarly, if the OEM makes the final decision, they should clearly document the basis for the decision. And, one or more parties need to keep this documentation for a long enough time to use in the defense of litigation.

Each party must evaluate whether their actions and decisions are justified and how critical of a problem might arise if there has been a mistake. Selling the wrong shade of paint can be a big financial problem, but no safety problems will result. Selling the wrong plastic, engine, valve, switch, or chemical can, in many situations, create big problems.

It is difficult for the purchase order terms and conditions or sales documentation to anticipate all issues in this area. At a minimum, the contracts could contain mutual indemnification provisions which provide that the responsible party will indemnify the non-responsible party to the extent they are responsible. That, at least, raises the possibility in which, if culpability is determined, the responsible party will protect the blameless party in the event of a claim or litigation or some other problem such as a recall.

Unfortunately, culpability is usually in dispute and these contractual provisions, if they come into play, may not work until the litigation is almost over. However, at least there is a common understanding that fair apportionment of financial responsibility is the goal.

Conclusion

It is important for all parties to be proactive and consider the consequences of bad decisions. Each of the parties should do what they can to prevent themselves and someone else from making a bad decision and not just rely on the law or an indemnification agreement to protect them. Such protection may not work and innocent product users may suffer. Working together to prevent safety problems in products will benefit all parties in the chain of production and distribution.

Kenneth Ross is of Counsel to Bowman and Brooke LLP in Minneapolis where he practices in the areas of product safety and liability prevention and counsels manufacturers, product sellers and insurers on ways to identify, evaluate and minimize the risk of product liability and contractual liability. Mr. Ross can be contacted at kenrossesq@comcast.net or 952-933-1195. This article appeared in the January 2008 newsletter of the Defense Research Institute’s Product Liability Committee.

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