Featured Product
This Week in Quality Digest Live
FDA Compliance Features
Matthew M. Lowe
Don’t wait until something bad happens to make a change
Kari Miller
A lack of integration hampers quality compliance across a product’s life cycle
Etienne Nichols
A well-defined CAPA program is a framework for quality and effectiveness
Grant Ramaley
IAF CertSearch now mandatory for accredited certification bodies
Etienne Nichols
What’s the difference?

More Features

FDA Compliance News
Creates one of the most comprehensive regulatory SaaS platforms for the industry
Company’s first funding round will be used to accelerate product development for its QMS and MES SaaS offerings
Showcasing tech, solutions, and services at Gulfood Manufacturing 2022
Easy, reliable leak testing with methylene blue
Now is not the time to skip critical factory audits and supply chain assessments
Google Docs collaboration, more efficient management of quality deviations
Delivers time, cost, and efficiency savings while streamlining compliance activity
First trial module of learning tool focuses on ISO 9001 and is available now
Free education source for global medical device community

More News

Gene Rider

FDA Compliance

Consumer Product Testing Rule Should Include Design Analysis

Product safety and corrective action systems overlook a chief offender.

Published: Wednesday, June 9, 2010 - 06:00

Approximately three-fourths of product safety recalls in the United States are the result of some design flaw in the product rather than a manufacturing or other defect. Most violations of the U.S. Consumer Product Safety Commission (CPSC) “small parts” standard, for example, are the result of nonexistent or inadequate design-hazard review, not defective materials or production techniques.

The CPSC is now preparing to propose the most significant product safety testing and certification regulations in its history, yet there is little mention of the importance of proper design-hazard analysis in product development and response to safety problems that arise. After spending a career successfully helping companies avoid product safety problems before they arise, I believe this is an oversight the commission must address.

Since the enactment of the Consumer Product Safety Improvement Act of 2008 (CPSIA), there has been enormous government, industry, and consumer-group focus on making sure products meet mandatory safety standards. These efforts have no doubt led to an increase in the compliance of products to important standards such as the lead paint limits for toys, which has benefited consumers. But this single-minded focus on standards compliance misses the root cause for the large majority of product-related injuries and deaths: inferior product design.

To be sure, CPSC commissioners and senior staff routinely discuss the importance of designing safety into consumer products. In fact, CPSC chairman, Inez Tenenbaum, rarely misses an opportunity to emphasize safety design in her speeches to industry groups. And many, if not most, manufacturers today incorporate conscious safety analysis into their product design processes. But despite this near-universal recognition of the critical importance of design-hazard analysis to product safety, virtually nothing has been done to move to a system that incorporates this process into product-safety regulatory and corrective action systems and programs.

I believe this is due in part to a failure to understand just how far the science of design-hazard analysis has come in recent years. When I first began working with companies to develop their product safety-design processes and resources, the field was more art than science. But with the demonstrated success of design-safety analysis programs and tools such as those that I worked to develop during the 1970s and 1980s, more and more manufacturers, test labs, and researchers began to dig even deeper into the factors that lead to product-related injuries and how to design products in a way to minimize such risks.

Today, numerous resources are available to a knowledgeable design analyst, from a growing body of CPSC and other product injury data to ever-more-refined knowledge in the human factors, epidemiological, engineering, and health fields. More sophisticated design-hazard analytical tools are also available that now enable manufacturers to dramatically reduce the chance their products will result in harm to consumers. The number of academic and industry resources and protocols available to design-hazard analysts increases every day. In fact, I am now participating in a first-of-its-kind international effort to develop training and skills qualifications for design-hazard professionals, called “Saf-D-Pro,” as well as a new Product Safety Management Certification Program. Other publications, including the CPSC’s Handbook for the Manufacturing of Safer Consumer Products, the newly issued European Union RAPEX Management Guidelines on product risk assessment, and ISO/IEC Guides 50 and 51 provide even more resources for today’s design-hazard analyst.

Congress mandated that the CPSC issue product testing and certification regulations that make consumers truly safer, not that impose costs on manufacturers and importers without a substantial benefit to product safety. But with the voluminous new regulations and their dozens of new testing requirements, it seems a significant, missed opportunity to me to fail to address what is by far the largest source of product safety-related injuries. I hope this will not remain the case, and that the legacy of this historic legislation will be truly safer consumer products. 

This article originally appeared in Product Safety Forum, a service of Product Safety Letter, www.productsafetyletter.com.  ©  Copyright 2010 by Oberle Communications LLC .


About The Author

Gene Rider’s picture

Gene Rider

Gene Rider is president of Intertek PLC’s Consumer Goods North America operations, a leading provider of quality and safety solutions, and president and founder of Intertek’s Risk Assessment and Management business stream.


Design Quality

Mr. Rider makes an excellent point. Too often when there is a problem we tend to blame manufacturers, particularly if they happen to be in Asia, without even thinking for a moment that the root cause of the problem may be within the buying entity!