Quality by Design in Drug Making

Pharmaceutical Engineering Quality by Design

The earlier in the manufacturing process you can address quality issues, the more cost effective the solution. Ideally, the problem is designed out before production starts. A quality systems manager at a company that supplies parts to Tier 1 auto makers told me that, for his facility, quality begins upon receipt of his customer’s drawing.

Defects get more expensive to overcome the further along the chain they appear. As a rough approximation, a defect caught on the production floor costs a manufacturer ten cents per part. The cost rises exponentially from that, to one dollar if the Tier 1 customer finds the problem and $10 if the OEM stumbles on the defect. If a faulty part makes it all the way to the consumer, a recall can cost $100 per part to the manufacturer.

Drug making, like the auto parts industry, is a must-not-fail enterprise, where quality problems can be life threatening. The FDA issued 54 drug recalls in 2015. Pharmaceutical manufacturers often look beyond their walls for advice on incorporating quality standards into their processes.

One place they turn is the auto industry, which has a storied history of embracing quality. Starting in 1950, Japanese manufacturers were learning about statistical control and other aspects of quality management from the American, William Edwards Deming. His insights were used by companies such as Sony and most keenly felt at Toyota, which was able to disrupt the domination of automaking enjoyed by Detroit’s Big Three (GM, Ford, and Chrysler). American car makers soon took to quality, out of necessity, and were travelling to Japan to learn their techniques. Ford recruited Deming to analyze its manufacturing system and the company was able to turn its fortunes around.

If you want to read more, see Quality by Design, an article that I researched for Pharmaceutical Engineering.


Bookmark the permalink.

Leave a Reply

Your email address will not be published. Required fields are marked *