Author: smartc

Waste Removal

Waste Removal Lean Biomanufacturing, Dr. Nigel J. Smart The million dollar question in lean biomanufacturing is (drum roll please)….how can we go about removing all of that waste? Although the process seems rather grueling, trust in the fact that waste removal is beneficial to your research. Waste removal will have a major impact on your team’s overall biomanufacturing goals. Yes, sometimes various components of your research cannot be eliminated. And if that is found to be true within your specific case, you’re not alone. Many researchers find that some components are just too vital to eliminate. Especially when it comes to raw materials, as it is vital that you deliver and check for defects before they are put to use. With that being said, you cannot always eliminate waste, but you can most certainly minimize it as much as possible. Now let’s get to it. It’s important to first eliminate components in your research that are most easily able to be eliminated, otherwise known as “low hanging fruit” components. Before going ahead and investing major time and effort into complex waste removal practices start with the materials that can most obviously be considered waste. Although this seems logical, many would be surprised at how many researchers overlook this step in lean biomanufacturing and instead strategize complex methods for removing harder to eliminate waste. Don’t fall victim to this practice....

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Value Stream Mapping

Value Stream Mapping Lean Biomanufacturing, by Dr. Nigel J. Smart No one company can do it all. It’s nearly impossible to implement every fresh, new research method that enters the market into your company’s regimen. To put it simply, not every method may best fit your company’s overall goals. Understanding this key concept will be invaluable to your research team’s overall operations. Science is ever-changing and although the industry is bursting with excitement, one can get a bit in over their heads with all of the new methodologies and research findings that enter into the market. Utilizing research methods that yield the best results for your company is a major key to success in this industry. Meet value stream mapping. Isn’t it nice to think of anything in life in its Ideal State? In lean biomanufacturing, it’s vital to identify the Ideal State of your process in order to truly hone in on your overall envisioning for your design. After all, a seamstress wouldn’t begin sewing pieces of fabric together without first strategically designing what it is she plans on making. In any process, it’s vital to understand what it is you are trying to achieve first and foremost. In lean biomanufacturing, this is called the future state map. The future state map should identify the condition that is most ideal for your team within your process. Note: You...

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Kaizen Events

Implementing Kaizen Events into Your Research Team’s Methodology Lean Biomanufacturing, Dr. Nigel J. Smart In lean biomanufacturing the term Kaizen events “refers to the impact of the outcome relative to the cost expended.” Much different than most constructive concepts, in a Kaizen event once the main event is complete, the researchers’ work is far from over.  In fact, their work has only just begun. These processes are quite complex and require strong attention to detail. A vital concept to take away is that each person involved in these events plays a key role in its process. In the pharmaceutical industry one accomplishment is only the next “go ahead” to the next big idea and so on and so forth. Although time consuming, high-detail follow-up work is a must in order to best monitor and fine-tune each method. It is with this type of work that you will see adequate success with Kaizen events. Let’s first just rewind a bit and explain what is involved with a Kaizen event. The process involves a “complete PDCA cycle performed within five business days, focusing on removing all forms of waste and bottlenecks from the process to create maximum value.” This should be normally factored into the process within 30 days of the event in order to capitalize on the work that was accomplished from there on out. It is important to note...

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Flow Charting

Getting to Know Flow Charting in Lean Biomanufacturing Lean Biomanufacturing, Dr. Nigel J. Smart When it comes to lean biomanufacturing, flowcharting is deemed as one of the most basic techniques for defining what is required to operate a particular process. It is no question that the biopharmaceutical industry has evolved quite tremendously in recent years, and as we adapt to these changes, it’s vital to understand the progression in which the industry is transforming. The pharma industry is developing in a very systematic manner, involving products and processes that were initially defined by R&D-based bench scientists. The cost constraints involved when developing pharmaceutical and biopharmaceutical products are significant, which is why final methods, ideals for development and production are not established until there is some sort of understanding, or rather proof, that the material in question will be an effective medical product. Here is a list of the basic operating principles defined in developing the flow of process: Process starting point Tasks/Actions Decision points (Yes or No) Tasks/Actions after the established decision has been made Process End Point A concise way of developing and analyzing potential medical products, the flow charting method is an effective way to ensure that the active materials in question are in line with the medical guidelines set forth by the industry. It is no question that flow charting can alleviate much of the time...

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Fishbone Analysis

Understanding the Basics of Fishbone Analysis Lean Biomanufacturing, Dr. Nigel J. Smart Tackling the demands of the biopharmaceutical industry can prove to be quite trying in today’s competitive field. Yet with proper research and experimentation, companies can readily understand the kinks in their systematic methods early on, leading to great success in their research. Tools like fishbone analysis can ultimately help yield accurate results and benefit researchers in the long term within their biopharmaceutical process. For anyone who is familiar with lean biomanufacturing, one may already know that lean is most commonly identified in the biopharmaceutical industry as a “holistic and sustainable approach that uses less of everything to produce more.” The financial burdens of today’s economy most certainly play a key role in this industry, which is why researchers utilize proactive methods of experimentation to best identify problems early on in their research. A standard fishbone diagram follows a simple, yet systematic approach to understanding the potential downfalls of each of the mechanisms in a biopharmaceutical process (i.e. materials, methods, machines, measurements, environment, and people.) Using fishbone analysis, a team of researchers creates a list of reasons to identify various problems in their findings. When utilizing this technique, one of the best practices involves creating a simple chart (template) for the responses of the research time, otherwise known as the ‘5 Whys’ Analysis. Create a list of “Why...

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