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www.intertek.com© Intertek 2010, All Rights Reserved.

Dr. Scott MilkovichGene RiderXiao ChenFebruary 16, 2010

Design Safety & Risk Assessment


Outline

1. Why Is Design Safety Important?

2. What Are the Critical Elements to Ensure Safe Design?

3. How Do We Ensure Consistency of Safe Design?

4. How Do We Assess the Risk of Our Products?


Fatalities from Consumer ProductsCDC 2006

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Key Stakeholders Recognize the Significance of Safe Design

Chairman Tenenbaum, Keynote Address, ICPHSO/International Cooperation on Product Safety, Toronto, Canada, October 28, 2009:

“In China, I emphasized two key messages to AQSIQ, our government counterpart, and to Chinese manufacturers and suppliers…that the best way to protect families is to build safety into products during design and manufacturing.

For CPSC, we identified that employing best practices to ensure product safety is not only the manufacturer’s job. U.S. importers also have a major responsibility. They must take steps to ensure that U.S. safety requirements are built into their products at every step of the way, including at the very beginning of the process as the product’s design specifications are developed.”

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U.S. CPSC Recalls (Toys)Bapuji, H*. & Laplume, A*. Toy Recalls and China: One Year Later. 2008.

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* University of Manitoba, Canada


Avoid Hazardous Design Flaws

• Problems with lead paint (which is a manufacturing flaw) aside, most errors that lead to recalls—not just of toys but of all kinds of consumer goods—are design mistakes. As such, they are the responsibility of the companies that dream up the products in the first place. And these mistakes are highly preventable.

• The U.S. Consumer Product Safety Commission maintains a public list of the top consumer hazards and reasons for recalls. Flawed design—sharp edges, long strings, and small detachable parts, for example—has been the cause of three-quarters of all U.S. toy recalls since 1988.

Copyright © 2008 Harvard Business School Publishing Corporation.

Bapuji, H*. & Beamish P**. Harvard Business Review.

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* University of Manitoba, Canada** University of Western Ontario, Canada


U.S. CPSC Recalls (Consumer Products)CPSC Recall Database 2004 –2008, n=1,736

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Recalls Across All Product Categories

Copyright © Pittiglio, Robin, Todd and McGrath (PRTM) 2002

Pittiglio, Robin, Todd and McGrath White Paper

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Outline





All of the tools to conduct effective design appraisals are readily available!


Critical Elements of Safe Design

1. Market place product entry requirements (standards & regulations)

2. Data analysis (recall, incident/injury/fatality)

3. Foreseeable use analysis (not foreseeable misuse)

4. Engineering / chemical / (micro)biological analysis (hazard analysis)

5. Product-consumer interaction (human factors)

6. Product characteristics (features, functions, not category)

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Incident/Recall Data: US

Recalls and Product Safety NewsNEISS On-line

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Incident/Recall Data: Canada

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Incident/Recall Data: Europe

• The purpose of the database is to facilitate targeted injury prevention and improve consumer safety in the Member States and at EU level by contributing to a comprehensive overview of the

injury spectrum within the Community

• The IDB Public Access is developed under the IDB Project of the Health Programme 2003-2008

Rapid Alert System for Non-Food Consumer Products

• RAPEX facilitates the rapid exchange of information between Member States and the Commission on measures taken to prevent or restrict the marketing or

use of products posing a serious risk to the health and safety of consumers

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• US Consumer Product Safety CommissionAge Determination Guidelines: Relating Children’s Ages to ToyCharacteristics and Play Behavior

• Health CanadaToys: Age Classification Guidelines

• International Organization for StandardizationISO 8124-1 Safety of Toys

• European Committee for StandardizationCR 14379 Classification of Toys – Guidelines

• British StandardEuropean Standard EN 71-6

Foreseeable Use: Age Grading

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• Askren, W.B. (2005). Predicting and Evaluating Misuses of Products. Ergonomics in Design, 05 Q1 15.

• McCune, L. & Rivera, N. (1994). Applying Knowledge of Child Development to Issues and Questions Regarding Product Safety. Presented at the Annual Meeting of the American Association for the Advancement of Science.

• Rogers, C. S., & Sawyers, J. K. (1988). Play in the lives of children. Washington, D.C.: National Association for the Education of Young Children.

• Ruff, H.A. (1984). Infants’ Manipulative Exploration of Objects: Effects of Age and Objects Characteristics. Developmental Psychology. Vol. 20, No. 1, 9-20.

• Vygotsky, L.S. (1978). Mind in society the development of higher psychological processes. Cambridge: Harvard University Press.

• Weegels, M.F & Kanis, H. (2000). Risk Perception in Consumer Product Use. Accident Analysis & Prevention, 32 (2000) 365-370.

Foreseeable Use: Example References

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Human Factors: Example References

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Human Factors: Technology

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Outline






Saf-D-Pro

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Saf-D-Pro

• RABQSA International is a recognized leader in designing, developing,and delivering accredited personnel and training certification services.

• RABQSA is accredited to the International Standard ISO/IEC17024:2003 Requirements For Bodies Operating The Certification OfPersons.

• ISO 17024 is the globally accepted benchmark for personnelcertification and focuses on the defining and examining of competence ofpersonnel.

• ISO 17024 introduces the requirement for a scheme committee todevelop industry defined competency-based criteria that are examinableand measurable. The resulting product of ISO 17024 is an accredited,certified person.

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Saf-D-Pro Scheme Committee

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Saf-D-Pro Introduction

Scope: To develop a competency-based personnel certification scheme to certify qualified individuals in the discipline of design appraisal of consumer products. Through a formal community of experts, develop and promote best practices in consumer product design safety assessment.

Design Appraisal: A technical document that identifies and characterizes the potential hazard(s) associated with a consumer product. The assessment can be conducted at either product design stage (preferably) or post-market stage.

Certified Safe Design Professional: Individuals who demonstrate the knowledge and skills to manage the process of design appraisal generation by taking a rigorous and multidisciplinary approach to adequately identify and characterize the potential hazard(s) of consumer products.

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Saf-D-Pro Certification Requirements

• Knowledge Requirements (written exam)– Market place product entry requirements;– Data analysis;– Foreseeable use;– Engineering, chemical and microbiological analyses;– Product-consumer-products; and– Product characteristics.

• Qualifications and Work Experience

• Personal Attributes (e.g., ethical, proactive & organized, systematic, logical)

• Skill Examination (hands-on evaluation)

• Certification

• Surveillance (every two years)

• Re-certification (every four years)

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Outline






Risk Assessment

Dirk van Aken, Voedsel en Waren Autoriteit (VWA), Netherlands

SCIENTIFICSCIENTIFICREGULATORYREGULATORY

INTERNATIONALINTERNATIONAL POST MARKETPOST MARKET


Risk Assessment


Risk Assessment

Commission Decision 2010/15/EU. OJEU L 22, 26.1.2010, p. 1.

Commission Decision of 16 December 2009 laying down guidelines for the management of the Community Rapid Information System ‘RAPEX’ established under Article 12 and of the notification procedure established under Article 11 of Directive 2001/95/EC (the General Product Safety Directive) (notified under document C(2009) 9843)

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:022:0001:0064:EN:PDF


Risk Assessment


Risk Assessment

Robyn EastonConsumers' Federation of Australia

Chair, Product Safety, ISO/COPOLCO


Risk Assessment


Risk Assessment

Why One Common Method

Risk assessment can be done in numerous ways but the recommendation is to use the method from the RAPEX guidelines as modified by WG IRAG (EU WG) as the standard method for risk assessment in general in Europe.


Thank you!

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