(MONTY RAKUSEN/CULTURA /GETTY IMAGES)
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The pharmaceutical and medical device industries can learn from Toyota's recalls to avoid their own "runaway" quality problems.
The same quality problems that surfaced during the recall of nearly eight million vehicles from the world's largest automaker
have a corresponding counterpart in the pharmaceutical, biotech, and medical device industries.1
The quality systems currently used in FDA-regulated industries have their origins in the military standards used in the aerospace
industry and the quality management systems of the International Organization for Standardization (ISO). At the heart of any
good quality program is the universal goal of making a product that is fit for its intended use, safe, and reliable, and that
consistently meets product specifications and customer expectations. Consequently, there is considerable overlap in the systems
used to ensure automobile and pharmaceutical product quality.
Robert N. Borghese
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Topics as they relate to the Toyota recalls and the corresponding pharmaceutical lessons are discussed in this article.
1. MANAGEMENT MUST TAKE RESPONSIBILITY
Toyota example: Toyota's Chief Executive Officer (CEO) Akio Toyoda took full responsibility and apologized before the US Congress on February
24, 2010.2
Lesson for Pharma: The top executive is ultimately responsible. That is why the FDA addresses warning letters to the top executive.
