© 2013 Applying Lean Principles in a Life Science Environment BioUtah November 6, 2013 Craig Gygi Lean Six Sigma Sensei & Author Executive VP Operations, MasterControl

© 2013 Agenda ‍Who is applying Lean? ‍What are the benefits? ‍Does Lean fit with life sciences? ‍What are Lean’s basic principles? ‍How does it work?

© 2013 Lean’s Ubiquity

© 2013 The Benefits of Lean Continually improving productivity Continually increasing value for customers Greater agility to respond rapidly (instantly?) to market changes Employee engagement and morale

© 2013 Challenges All Companies Face Understanding your customers. Who are they? What do they really want and need? What’s their rate of demand? What constitutes satisfaction? Characterizing your most pressing issues. What’s going wrong? What are the priorities? Where are the mistakes and challenges coming from? Mapping your value streams. What are your work processes? Which are routine? How do material, information, and transactions flow through them? Identifying and reducing waste. Where and when is it occurring? Calculating takt time. What is the rate of customer demand? How frequently do they use your services or buy your product? Clearly identifying your goals and objectives. What are you trying to accomplish this year? In three years? In ten years? Engaging your people. The people in your organization have great ideas for solving issues and satisfying customers. How can you leverage their wisdom? Implementing continuous improvement. How will you institutionalize the practice of repeated improvement?

© 2013 Lean Principles Focus on the customer. Keep the customer at the center of everything you do—their wants, needs, and their definition of value. Put your people first. Tools and technology exist to aid and assist people. Go to gemba. Get up, get out, and see what is actually happening, where it is happening, for yourself. Keep it simple. Simplify and eliminate before you automate and integrate. Make it visual. Everyone needs to be able to see the status of work and where there is trouble. Make small improvements, continually. Lean is a journey, not an event or a destination. Standardize work. Consistent work and practices are the foundation of rational management and improvement. Apply it everywhere. Every part of an organization has waste and needs improvement. Follow the value stream. Value flows from you to the customer. Design your work to keep the value stream flowing and recognize when it’s not. Balance is key. Use all the principles and tools. You can’t pick and choose.

© 2013 Tool: Seven Types of Waste ‍Transportation. Waste in life science work is the unnecessary and non-value- added movement of people, goods, and information in order to fulfill the obligation to the (internal or external) customer. ‍Waiting. If people, systems, materials, or information are waiting, that’s waste. ‍Overproduction. Are your processes producing sooner, faster, or in greater quantities than the (internal or external) customer is demanding or requiring? ‍Defects. Whenever you do not deliver the correct requirements to the (internal or external) customer, the first time. ‍Inventory. Do you have products or services no one wants? Or products or services that are waiting to be released? ‍Movement. Are activities, paperwork, and other efforts unnecessarily juggled? ‍Extra processing. How much extra paperwork or effort do people go to in order to deliver your product or service? Could any of these steps be eliminated?

© 2013 Tool: 5S ‍Sort. The need for workplace organization is universal. Sorting of information, materials, and tools is fundamental to the delivery of quality and timely products/services. Much of life sciences is computer-based or computer facilitated. Sorting computer environments— s, file systems, etc.—is a Lean activity. Keep your computer desktop and file system Lean and clean. ‍Straighten. Information/research/production tools should be arranged in standard locations for consistent and easy access. This includes desk items, databases, repositories, references, operating procedures, or process definitions. Information, including file and system names, should be consistent. ‍Scrub. Maintain information/research/production tools in a neat and clean condition. This includes any work areas, whether in the office or in the field. ‍Systematize. Don’t wait for things to build up. As part of your regular routine, go through your work environment and maintain it. Define a certain time or regular event as the basis. This includes both private and common areas. ‍Standardize. Exercise discipline in maintaining your workplace and institute processes that ensure that this regular maintenance occurs, in a standard manner to standardized levels. Don’t overdo it—just do it.

© 2013 Hospital Blood Lab Case Study ‍What does Lean look like in practice? ‍Let’s look at a laboratory queuing and workflow application…

© 2013 Initial Lab Conditions ‍Requirements:  Complete routine requests within 120 minutes  Complete urgent requests within 30 minutes ‍Challenge:  Blood lab needed help keeping up with their incoming work load ‍Performance:  Urgent request volumes started exceeding lab capacity  Prevalence of “false” urgent requests  During peak periods, request completions often took considerably longer than requirements  Irate calls and visits from customers and managers

© 2013 Initial Lab Layout & Flow

© 2013 Lean Improvements ‍Lean the lab layout. Added one centrifuge and rearranged all centrifuges in line with hematocrit and alternative blood machines, reducing processing time ‍Flex staff hours. Two day-shift technicians modified their hours to accommodate high morning volumes. Capacity to meet demand with no additional headcount. ‍Error-proofing labels. Updated SOP guidelines so staff could better align sample labels. Reduced errors and associated rework. ‍Educating internal customers – redefining “urgent.” Worked with internal customers to only designate requests as urgent when needed, not just to “game” the system in an attempt to get a quicker results. Significant reduction in number of urgent requests.

© 2013 Improved Lab Layout & Flow

© 2013 Improved Lab Performance ‍Peak hours effect dampened:  Routine requests completed within 45 minutes  Urgent requests completed within 25 minutes  “False” urgent requests decreased by 80% ‍Improved morale:  Reduced employee stress  Employees spending more time on testing and less on fielding complaints from customers and managers  Increased employee engagement and satisfaction

© 2013 Conclusion If you aren’t using Lean in some way now, why aren’t you?

© 2013 Q & A

© 2013 Thank you!