What the Pharmaceutical Industry Can Learn From Toyota's Recalls

Twelve lessons of what to do and what not to do to avoid quality problems.
Jul 01, 2010


(MONTY RAKUSEN/CULTURA /GETTY IMAGES)
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
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.