PhM: Besides developing black belts and green belts, you’ve asked all employees to achieve yellow-belt level. Has the implementation of this been fairly straightforward so far (via electronic training) and well received?K.B.: We developed our own yellow belt program after having reviewed several introductory programs in different sites. The program consists of three elements:a. Online training modules covering the key concepts of OEb. One day classroom-based training facilitated by our OE leadc. Completion of a project which will deliver a specified nominal valueThe program has been very well received by all employees who have completed it. Over the past six months since launch we have trained approx 30% of the site workforce to yellow belt level.PhM: In Elan’s certification requirements for yellow belts, it is written, “Complete Project worth $2-5K (and/or safety/compliance improvement)” Can you clarify what this means?K.B.: The employee is responsible for identifying an improvement that will bring about a cost saving of $2,000-$5,000, or alternatively the improvement identified can enhance safety or compliance on site. Where the project has a direct cost saving/avoidance, then this is calculated in conjunction with their manager and verified by the finance function and OE lead.PhM: You say that “only you” can change culture, but have you also made use of outside consultants and trainers? If so, how do you best incorporate their support?K.B.: We have used consultants to educate the leadership team as to how companies have implemented OE programs and to advise us on the model/strategy that might work best for us. We have also utilized them for initial training and certification of Green Belts and Black Belts.PhM: Would you say that you have reached the point of being a “learning organization,” and how is this best illustrated, and measured?K.B.: I think we have reached a certain level that shows how effective OE is, but there are always elements you can improve on—the way we learn from issues that occur by effective root cause analysis and implementation of effective corrective actions is case in point.PhM: You started your OE implementation in 2009 with “low-hanging fruit.” Were some of these projects more challenging than you anticipated?K.B.: Yes, because even though these ‘low-hanging fruits” were the obvious places to start to achieve quick wins, they focused on culture change, so it was all very new to the employees and they were not quite sure what it meant. The idea of these initial projects was to engage with people on the program and use the tools and techniques of DMAIC (Define, Measure, Analyse, Improve, Control).PhM: Is there anything you could have done better to date?K.B.: Yes, looking back there are always things you would improve—the key element I have learned is that you cannot over-communicate to employees when discussing OE, and I think we could have done more of this earlier in the program, particularly at middle management levels.PhM: In your Voice of the Customer (VOC) work, how elaborate is the process of understanding what is “critical to quality,” and how often do you work with partners to review these factors and modify them if need be?K.B.: We have regular meeting with our customers, and over the past year have introduced them to the concepts of OE. We have carried out customer surveys and discussed with them what they consider of value. Typically they want product on time combined with the highest quality standards possible which is what we strive to achieve.PhM: Is it fair to say that your OE culture has rubbed off on partners and raised their standards and expectations as well?K.B.: Yes, in some cases. As we deal with small and large pharmaceutical companies, some have more experience of what OE is than others. In some cases there is an expectation to provide continuous improvements to our customers and we have positioned OE as the vehicle to achieve these improvements. Most, if not all, of our customers have been very impressed with our OE program and are interested in learning more about it.PhM: Finally, how do you “celebrate success” with your partners?K.B.: Typically, this can take the form of reduced cycle times and measured by such metrics as OTIF (On Time in Full) and RFT (Right First Time). Where price reductions have been achieved, these savings can be passed on to our customers. Ultimately we are providing our customers with what they want, which is highest quality product with short lead time and low cost.