Several years ago, I spent a summer working for a company that manufactured communication antennas. I can still remember the quality control analyst coming by, twice a day, with a grocery cart full of parts that had been rejected for not meeting tolerance standards.

I was amazed at the amount of work that went into creating these parts, just to have such a large volume returned because they did not meet quality standards. What a waste!

The main problem with late-stage quality analysis is that it only detects and gets rid of substandard products or parts—it doesn’t prevent them from being created in the first place.

As manufacturing has evolved over the years, companies have put in place a variety of techniques to evaluate quality more rigorously, and in many cases, to embed quality control throughout the manufacturing process.

In a recent article in Pharmaceutical Technology, Hermes Pharma‘s Analytical Development Senior Manager Martin Koeberle, Ph.D. and QbD & Drug Regulatory Affairs Senior Manager Wolfgang Schiemenz discuss the use of quality by design in pharmaceutical manufacturing.

By utilizing quality by design techniques, pharmaceutical companies like Hermes Pharma are able to determine critical quality attributes (CQAs) that may significantly affect the quality of their final product. By honing in on these CQAs in advance, the team can identify the key variables that affect the production process, or critical process parameters (CPPs). These can be actively monitored to avoid any deviation in the manufacturing process, ensuring product quality and that CQAs are met.

Techniques such as this also may enable the company to simplify regulatory compliance. By making early adjustments to the manufacturing process, they can avoid costly late-stage adjustments that have to be formally registered with regulatory bodies after large scale production has begun.

As pharmaceuticals become increasingly complex to manufacture, it’s more important than ever that quality is designed into the them from the beginning to ensure patient safety. And ultimately, to deliver a better product that improves lives and better patient outcomes.

If you haven’t checked out the article, it’s worth the read. The lessons learned can be applied across many industries that are working to boost production output, reduce throughput times, lower costs, and deliver an amazing products that meet the needs of customers.

How are you helping your employees to work smarter by reducing the amount of time they spend on non-productive activities and correcting errors? If your business processes need a “check-up,” please email me at michael@leadingchangeforgood.com! I’d love to help you get back to a healthy, productive workplace.