An Rx from Pharma: Quality by Design
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...
Read MoreUnder the Microscope: What Do Your Business Processes Tell You?
I spent a good bit of my early career doing scientific research for several amazing organizations, including Wadley Research Institute (now part of Carter BloodCare), the University of Texas Southwestern Medical Center, Mallinckrodt Medical, Inc., and Eli Lilly and Co. Back then, I worked with microbes such as bacteria and yeasts – tiny creatures that individually are too small to be seen with the unaided eye. I studied them to improve medicines and treatments for a variety of diseases. Working on these sharp scientific teams to make a difference for sick people who really needed these therapies was extremely rewarding. One of my favorite parts of research was cell staining, a technique used to better visualize cells and cell components under a microscope. By using different stains, you can preferentially stain certain cell components, such as a nucleus or a cell wall, or the entire cell. It may sound complicated, but really, it clarifies things. The staining process helps you look at the same research question through many different perspectives – or sets of data. It led to a lot of “aha” moments! Today, in my work as a business operations consultant, I use Six Sigma, Lean and other process improvement techniques in a similar way to cell staining. It’s almost like you’re staining collected information with these different tools, so that it stands out better for analysis and informed decision making. Tools such as pivot tables, graphs and charts turn data into pictures, drawing our focus to facts that might otherwise be obscured. I am so thankful for my training as a scientist, and my many years of staring into microscopes. Asking good questions and analyzing data are still at the heart of what I do as a business excellence coach. I love what I do! If you have a business process that needs a “check-up,” please email me! I’d love to help you get back to a healthy, productive...
Read MoreOperational Improvement Tips for Your Small to Mid-Sized Company
For my birthday a friend gave me a pair of gloves for surviving these rough Midwest winters where I live. They are beautiful, and very much appreciated. Inside the gloves, however, is a small tag that reads, “One size fits all.” Trying them on proved that claim to be a bit of false advertising! Thankfully my friend didn’t mind making a quick exchange for me, and now I am set for the next snow season months away. The incident made me think, though, about companies that try to adopt the “one size fits all” mentality, especially when it comes to improving business processes. Implementing process improvement programs such as Lean and Six Sigma can sometimes feel like a glove that doesn’t fit right. There are ways, though, to deploy data-driven tools like Lean and Six Sigma for smaller and mid-sized organizations that doesn’t require the massive all-or-nothing approach. It allows them to implement at a slower, more manageable pace. The strategy and projects are directly aligned to the organization’s strategic plan and customer needs. As a result, they often are more successful in achieving business improvements quickly, and on a grander scale, than their larger counterparts. Even if you are a biotech or pharma start-up or a not-for-profit with 5 or less employees, you can benefit from taking a data-driven approach to your business operations. How can I use data to be smarter about my financial projections? How should the start-up prepare itself for growth? What must be done to meet the milestones established by the investors (market)? How does a company know if it can achieve its goals? Are resources appropriately applied; is this the best ROI that can be expected? What risks must be addressed immediately? Sometimes small to mid-sized organizations don’t realize that their size actually puts them at an advantage in the market, if they can just harness their data to make smart business decisions. If you run a small to mid-sized organization, what has been your experience with operational improvement initiatives? I’d love to hear your story! If you have a business process that needs a “check-up,” please email me! I’d love to help you get back to a healthy, productive...
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