The Greatest Quality Management System Failures in History

In 1997, General Motors, Ford and Chrysler became QS 9000 registered. QS 9000 is the equivalent to ISO 9000 for the automotive industry, and all three major automotive manufacturers – Ford, Chrysler, and General Motors are QS 9000 registered and require their vendors to be ISO 9000 registered, as well. In spite of this history of quality management in the automotive industry, Ford Motor Company has recalled over 24 million vehicles for various malfunctions since 2004. General Motors recalled 1.9 million vehicles in March of 2010 alone, and Chrysler had a double recall of its minivans in 2011.

U.S. automakers are not the only companies with massive recalls despite ISO quality initiatives. In April, 2005, Honda established the Global Honda Quality Standard (G-HQS) which is based on ISO 9001.  In addition, as of March, 2011, 43 of their 46 production facilities attained ISO 9000 registration.  Despite this tremendous effort, in September, 2011, Honda made one of the largest global recalls – 1 million vehicles with electrical problems which could cause fire hazards and allow the vehicle to roll backwards in the forward, or drive position.  

Large global companies face challenges monitoring and auditing the quality standards of their subsidiaries, as evidenced in a recent recall of over 1.4 million packages of birth control pills by Qualitest Pharmaceuticals, a subsidiary of Endo Pharmaceuticals, a company based in the U.K.  Endo Pharmaceuticals is certified in ISO 900/9001/9004/19011:2000, which would indicate the company adheres to a comprehensive quality program.  The recall came from their operation in Alabama, due to a labeling error on over 1.4 million blister packages of oral contraceptives.  The labeling error reversed the sequence for taking the contraceptive pills, which could have resulted in unplanned pregnancies and a possible global population explosion!

There is nothing more frightening to parents than a recall of children’s toys, especially from one of America’s most reliable and trusted toy manufacturers   But in 2007, Mattel, an ISO 9000 registered company and maker of popular toys such as Barbie, Polly Pocket and “Cars” movie items, recalled over 11 million toys made in their Chinese factories due to the danger of lead paint and small magnets that posed a choking hazard.  Though no injuries were reported with this recall, approximately 19 reported injuries and one death caused a similar toy recall in November 2006.  The Chinese manufacturing company responsible for production of the recalled toys was ISO 9000 certified at all its locations, bringing to light the responsibility of global companies to monitor the adherence to quality standards of its suppliers. 

One of the most notorious cases of product failure was Bridgestone/Firestone tires. In 1994, they were the first tire manufacturer to achieve ISO 9000 certification. Six years later, In 2000, they voluntarily recalled over 6 million tires after a federal investigation revealed tire tread separation was linked to 46 deaths. During the investigation, former Bridgestone/Firestone employees testified the rubber used for tire manufacturing was expired and other parts were compromised due to improper controls and hasty inspections.

A quality management system is only as effective as management’s dedication and insistence to adherence and accountability.  Current documentation and audit schedules aren’t enough.  The system will only be as effective as the people in the organization and the investment in training, inspiring and leading employees as they take responsibility for the system’s operation and results.

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