By | September 7, 2021

Have you heard the story about a woman who 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.

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, 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.

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.

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 the product lifecycle— from concept to design to manufacturing and service—to ensure that the product will operate safely and reliably. Stage gate review and approval steps embedded within the product lifecycle 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.

There are various FMEA standards and guides used by the different manufacturing industries, for example, the automotive industry uses the AIAG FMEA handbooks, and medical device manufacturers proactively comply with standards such as ISO 13485, an internationally agreed-upon standard that sets out the requirements for a quality management system involving use of various risk techniques including the FMEA. The focus of risk management in discrete manufacturing is on both safety and performance of the products and includes risk assessment coverage across the supply chain.

Often, there is intense pressure to release products sooner than later for economical reasons. However, releasing products without considering potential quality- and safety-related issues through a comprehensive risk assessment and corrective action process, at various stages of product life cycle, could result in product recalls, damage to reputation and liability costs.

Are these risk assessments capable of preventing all such incidents? Probably not, but a well-structured and high quality FMEA study would reveal the potential gaps and help to eliminate or minimize the likelihood of their occurrence.

Contact us to learn how we can help with FMEA.