Product Qualification and Recall Consulting
The regulatory and litigation environments in the United States require that potential safety issues and problems with mass-produced products be investigated rigorously. Assessment of the root cause of warranty claims and potential problems related to a particular product will help quantify the risk associated with that product, and the affected population, allowing the manufacturer to make informed decisions on continuing production, potential design changes, and any corrective action. Exponent’s multidisciplinary teams can address every aspect of product design, manufacturing, and use issues to develop information that equips the client to make appropriate business decisions.
We draw upon 40 years of failure analysis and safety evaluation experience to provide a unique perspective on qualifying new products for market. We provide testing services to address a wide variety of common failure modes that are known to have triggered recalls, as well as critical analysis of proposed products from a safety perspective. Exponent’s database of more than 300 million accident and incident records enables us to quantify the performance of a particular product line. Our Human Factors consultants evaluate warning labels and instructions to ensure appropriate communication with the buyer and user of the product. We review manufacturing procedures to assess potential process risks. In fact, with more and more products being manufactured offshore, quality process is a significant concern among U.S. suppliers and manufacturers. Exponent’s China office addresses specific quality and design issues for U.S. and international clients with manufacturing facilities in Asia and the Pacific Rim.
Our consultants work with clients to respond to regulatory agency investigations and have presented findings in front of the major U.S. regulatory bodies, including the Consumer Product Safety Commission (CPSC), Food and Drug Administration (FDA), National Highway Traffic Safety Administration (NHTSA), and the Environmental Protection Agency (EPA). Our approach is focused on the robustness of the product related to particular safety concerns, so that if and when a failure occurs, it will occur safely.
Examples of Product Qualification and Recall Work
- Product failure investigations
- Incident scene investigations
- Statistical analysis of warranty data
- Design quality auditing
- Manufacturing quality auditing
- Safety qualification testing
- Regulatory support
- Qualification planning (testing at the manufacturer)
- Warnings, labeling, and instruction assessment
Selected Exponent Product Experience
- Kitchen appliances
- Coffee makers
- Building control systems
- Heaters and air conditioners
- Portable electronic devices
- Battery systems
- Electric blankets
- Medical devices
- Automotive and truck components
- Toys and children’s products
Relevant Practices
Project Examples
Comprehensive Product Evaluations Exponent was retained by several multinational corporations operating in Europe to help with comprehensive evaluations of some of their new environmentally friendly products. We examined their product designs and manufacturing operations to estimate field performance under warranty and to identify potential safety concerns.
Power Adapter Failure Investigation A consumer product manufacturer approached Exponent with reports of heating and melting in the cables from power adapters to the computer. The adapter had passed rigorous qualification tests designed to detect wear-out due to fatigue of the wiring without showing these problems. Upon our investigation, we found that fraying of the wires at a bending location lead to a short circuit on the low voltage side of the adapter. This lead to melting, and eventual failure of the product. Exponent was able to demonstrate that the protection circuitry in the adapter worked as intended, and did not allow enough energy to be dissipated in a short circuit to cause a hazard. Exponent recommended that the manufacturer’s qualification tests be changed to energize the adapter while fatiguing the cable as the fatigue alone was not enough to show a problem, but the resulting short circuit was.
Coffee Maker Qualification Coffee makers have exceptionally high power usage for their size, and if this power gets misdirected, it can lead to shock or fire risk. Exponent has worked extensively on multiple models of coffee makers with regard to potential product recalls. Because of our knowledge of the failure modes associated with these products and other kitchen appliances, we have designed and executed forced failure test plans to evaluate new designs. These test plan rely on a forced failure approach: assume that single-point failure can and will occur, and make sure that the new designs are robust to these failures. Exponent can perform this qualification work in our labs, or work with clients to design test plans to be executed in their own facilities. Either way, our unique perspective allows us to apply our past knowledge to new designs.
Gas Valve Recall As a result of customer complaints, a global automation, controls, and process solutions company identified a problem with certain models of gas valves used in a wide range of commercial and consumer appliances. The gas valves would sometimes stick in the open position and allow gas to flow even if the pilot went out. By reviewing the gas valve manufacturing and assembly processes and conducting a failure analysis investigation of failed gas valves, Exponent determined that the root cause of the valve failures stemmed from a subtle change to one of the manufacturing steps. By analyzing the differences in gas valve construction for the different models and performing targeted laboratory testing, Exponent determined that the extent of the product recall could be limited to a small fraction of the total gas valve population
top |