Recently, an Australian woman suffered burns to her face after her battery-operated headphones exploded during a flight from Beijing to Melbourne. On that day, the health and safety of all the passengers on board that flight was compromised because of one malfunctioning headphone battery. With the flaming device thrown on the ground and the smell of burning rubber permeating the cabin, flight attendants had to douse the fire quickly. One can only imagine how scary the situation must have been for the passengers and crew.
We think the responsibility of the safe operation of such gadgets lies with the manufacturers, and this is where time-tested, structured and systematic risk assessments such as Failure Mode and Effects Analysis, or FMEA, and Fault Tree Analysis can help. FMEAs are designed to show manufacturers where product quality and reliability could suffer, and allows them to fix these errors early in the product development life cycle. Likewise, Fault Tree Analysis starts with an undesired outcome as the root of a logic tree, documents the events that could lead to that outcome and helps identify the most consequential causes for the event or failure.
Strategic organizations take a proactive risk-based approach to quality improvement, and perform such risk assessments by engaging cross-functional and multidisciplinary teams. The teams collectively inventory all potential failure modes, causes and effects, identify the severity of the effects and likelihood of the causes to calculate overall risk for a failure, and build controls to reduce the risk to an acceptable level.
The other popular risk management terms used in the industry are “scenario analysis” and “event tracking.” Prior to this headphone incident, there have been incidents of exploding mobile phones on airplanes and electrical system problems stemming from lithium-ion batteries in newly introduced airplanes. It behooves battery manufacturers to make a list of all environments where their batteries could be used—hot, cold, high and low pressure, high and low altitude, subterranean, underwater, humid, dry, various battery charge levels, and so on—and learn from incidents affecting others in their industry.
This is no easy task, but it can be simplified using a system that can help standardize a quality risk assessment workflow through a systematic progression from capturing of failure modes to the assessment of risk and identification of controls at various product development stages.
Shared knowledge libraries can help disseminate historical knowledge and lessons learned to the teams responsible for product quality. Critical control lists identified as part of the FMEA can be traced throughout product lifecycle—from general hazard analysis to design and manufacturing—to ensure that the product will operate safely and reliably. Stage gate review and approval steps embedded within the product life cycle can ensure proper application of the risk assessment procedures and effectiveness of identified controls before a product moves on to the next stages of development.
We recommend that manufacturers of devices, where quality issues could result in safety issues for the consumer, proactively consider compliance with standards such as ISO 13485, an internationally agreed-upon standard that sets out the requirements for a quality management system specific to the medical devices industry. The new version of ISO 13485 places greater emphasis on risk management and risk-based decision-making. The focus is on risks associated with the safety and performance of medical devices and includes risk assessment coverage across suppliers, requiring adequate controls such as written agreements. Given the proximity of lithium ion battery operated devices with patients and general population during everyday use, it will not be surprising if regulators start mandating risk assessments from battery manufacturers should more such incidents start making headlines in the news media.
Often, teams are under pressure to release products sooner than later. However, releasing products that have not anticipated quality- and safety-related issues through a comprehensive risk assessment and corrective action process, at various stages of product life cycle, could lead to dangerous consequences.
Are these assessments capable of preventing all such incidents? Probably not, but a solid FMEA or Fault Tree Analysis will reduce the likelihood of their occurrence. Product recalls, damage to reputation and liability costs are a few of the many consequences of lower-quality products.
For more information, visit spherasolutions.com/operational-risk/quality-risk/.
