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.
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.