With the pharmaceutical industry facing growing pressure to reduce costs and accelerate the development and commercialization of novel medicines, Servier CDMO recognized that added value could best be provided to its customers by increasing the productivity and efficiency of its own operations.
The company’s existing and ongoing continuous improvement program typically delivered improvements on the order of 5-10% annually. To provide measurable added value to its customers, Servier CDMO aimed to achieve more significant improvements on the order of 20-25% within 2018 in EU and 2020 throughout the entire network.
To achieve such significant change, the company needed to launch a transformation. That required moving beyond continuous improvement to Operational Excellence (OPEX)..A packaging pilot program was implemented at Servier CDMO’s site in Ireland in 2016. Teams from plants in France and Poland were also trained so they could, in turn, deploy the program at their facilities. Since then, 11 mini-transformations have been completed at four sites, two more are in progress and an additional two will be launched during 2018, for a total of 15 transformations at six different facilities. The company intends to have achieved a 25% reduction in costs at all sites by 2020.
Operational Excellence is an approach to organizational improvement that focuses on meeting customer needs. It is a new way of working that is based on teamwork and employee empowerment that involves eliminating all types of waste from business operations. The result is increased productivity and efficiency — and improved performance.
Through its OPEX program, Servier CDMO is gaining greater control over all business processes involved in the provision of pharmaceutical custom development and manufacturing services. Supply chain management from procurement of raw materials to packaging components is enhanced. Performance, with respect to quality assurance, environmental management, energy consumption, production costs and scheduling is improved. A right-first-time approach results in a production process with minimal losses.
As importantly, all employees at Servier CDMO have a better understanding not only of their responsibilities, but also their roles in the company, where the company is going and how it will get there. All of these improvements lead to a company with enhanced Corporate Social Responsibility and a higher level of trust with partners across the value chain and beyond, including regulators
Servier CDMO’s OPEX approach focuses on Productivity Improvement using the mini-transformation (mini-T) methodology. Controlling Productivity results in greater control of production processes and product quality, as well as the minimization of losses, leading to the creation of added value for the company. Employees are trained in new skills and granted the autonomy to make rapid decisions when appropriate.
The first step in introducing the mini-T methodology at Sevier CDMO involves education of the production team about three key OPEX concepts: the operating system, management infrastructure and mindset and behavior.
In addition to these three key elements, it is essential that managers learn how to lead the transformation and ensure the results are sustainable. They must be prepared for the mindset transformation to become Lean Leaders. Managers attend an additional “bootcamp” where they are introduced to the methodology, including the various Lean Tools that are used, such as process confirmation, Overall Equipment Effectiveness (OEE) and Overall Process Effectiveness (OPE) calculations, problem-solving, Single Minute Exchange of Die (SMED), value-stream mapping (VSM) and gemba walk. Much of the training is conducted on the plant floor where managers learn by doing.
The mini-transformation takes 18 weeks and begins with observations, measurements and interviews to gather the information needed to define the current operations and identify potential areas of improvement. This phase, and the next — designing of a new solution that will result in a more productive and efficient process — are each completed in approximately three weeks.
Implementation of the solution then takes place over the next two and a half to three months. Once the mini-T is completed, the dedicated OPEX team leaves the production area and the operational managers are responsible for sustaining the results. Following the initial increase in performance achieved during the mini-T, regular additional improvement is also expected.
As part of a mini-T, the operators develop the “standard work” for the new process – a visual and documented reference that defines and organizes the work needed to achieve optimal quality, safety, quantity, and cost. For managers and supervisors, the “standard work” for managing performance is “standard agenda,” which balances their weekly schedule on Capacity Management / Problem Solving / Process Confirmation & Coaching/feedback. Process Confirmation is the way by which managers “go and see” that the process is delivering its target condition and, where it isn’t, identify and act on the root causes.
The first OPEX project at Servier CDMO involved packaging and quality control labs area in Arklow (Ireland). This program was then deployed on the European sites; all the product flow area followed in the transformation. The processes, flows and equipment use were analyzed using VSM or Material Information Flow Analysis (MIFA), considering the value they provided as seen from the customer perspective.
New solutions were designed to simplify the way the work was completed so operators could work more efficiently with better added value. The changes made allowed, for instance, for reduction of the number of full-time operators on each packaging line from two to one. One additional person is available to help as needed on the different lines. In addition, each shift begins with a 5-minute meeting to discuss the current state of operations and any problems that arose in the previous shift so each operator understands the priorities for his/her shift and what needs to be done. After one year, the packaging perimeters productivity increased within a range of +15 to +30%.
During the analysis of the packaging process, one important observation was the length of the time required to switch between boxes of different sizes. SMED methodology was used to determine the most efficient process for changing the box format on the line.
The Single Minute Exchange of Die methodology is used to safely achieve the lowest possible changeover time by thoroughly examining all tasks from the end of one job until the next job is operating at a steady state. First, the total job time is determined, then the internal and external tasks are separated, and wherever possible, the internal tasks are converted to external tasks. Both internal and external wastes are then eliminated, and the final best practice is tested, standardized and maintained.
Operators were involved in the process, helping to define the improved operation. They determined the best way to do the work in the least amount of time with good quality and safety. The procedure was written as a standard work that is now used to train new operators.
Reducing the change time has provided numerous benefits. In addition to reducing operating costs by freeing up available resources (man and machines) to perform more value-added work, Servier CDMO’s available capacity and flexibility to respond to customer demands is increased. As a result of this mini-transformation, the productivity of Manufacturing Unit 1 (Gidy – France) increased by more than 39%.
The foundation and main goal of the OPEX program at Servier CDMO is to achieve these high levels of increased productivity by simplifying activities and enabling employees to work smarter. The OPEX program is much more than a lean management program. It is a deep transformation through balanced opportunities within the three dimensions of OPEX (Operating System, Management Infrastructure, Mindset & Behaviors). New methodologies and lean tools are used in a step-by-step manner to identify the best levers to work on, the root causes of problems and develop solutions that lead to improvements in operations.
A problem is considered to be a gap between the current situation and the defined standard, which is developed based on best practices. Root-cause problem solving is a method based on a structured and systematic approach for finding and tackling the root causes of the identified gap with long-term solutions rather than short-term quick fixes. The most effective problem solving takes place on the shop floor and focuses on all aspects of the issue — the people, the process and the parts. Most importantly it should be viewed as an opportunity to improve the way work is done and not a place to blame.
The deep problem-solving method is just one of the many new tools that employees of Servier CDMO have been trained. This method and other lean tools challenge people to change the way they think about their specific work and their role in the overall operation of the plant. Indeed, the Operational Excellence program at Servier CDMO has focused extensively on dealing with the behaviors of employees and has required the development of real trust within each OPEX team.
Managers, in particular, have had to gain many new management skills to ensure the successful implementation of mini-transformations and that productivity enhancements are sustained and expanded upon. They need to understand their new roles as managers of transformations. They are no longer traditional managers, but lean leaders that must have a vision of performance that is efficient but also ensures quality and safety.
These initial transformations are just the first steps in the implementation of Operational Excellence at Servier CDMO. Currently, the focus is on the shop floor — manufacturing, packaging, logistics and quality control operations.
In the near future, we will be expanding the OPEX program to other activities, such quality functions. There is tremendous opportunity to enable people to work smarter and thus huge potential for improving productivity and efficiency. Given the challenges with changing the way people think and behave, we are also focusing additional efforts on people development, including the implementation development programs for managers. This phase will enable Servier CDMO to achieve further advances and ensure that implemented transformations are maintained and improved upon.
We are also exploring the use of new technologies, particularly digital capabilities, to enhance our OPEX program. OPEX is, in fact, a never-ending story. At Servier CDMO, we are committed to continuous improvement using state-of-the art tools that enable our employees to have more freedom to make decisions, including solving problems, that enable them to work smarter and safely, providing high-quality products for our customers.
Sébastien manages the OPEX (Operational Excellence) deployment over 11 industrial sites, to achieve Servier’s Industry Division commitment on production costs targets. Focused on value added activities and change management, Sébastien operationally designs the Institute of Management for Performance Success (1st Servier internal LEAN Academy for managers). He supports international site change teams to deploy the Performance and Change Management techniques. With over 10 years in Chemical Development Sébastien is an expert in Chemical engineering. And with a cumulative experience of 7 years in Performance and site Steering committee, he is used to managing strategic road map building plans, as well as performance and change management topics, like LEAN 6 Sigma deployment, ORIL Industrie 2020 transformation road map and 1st internal LEAN Academy for Managers (IMPS). Prior to joining Servier, Sébastien acquired versatile experience through almost one year in the GE Medical Systems production department (BUC France) and through another year in the Eastman Kodak Research & pilot center in Rochester (USA-NY). Sébastien then worked for 7 years as a Chemical process engineer in the Servier’s Industrial R&D Center in Normandy, where he managed all scale-up and process development studies for API crystallization and thermal process safety. He then lead this Process Engineering Department for another 3 years, before moving to the head of the office to manage OPEX.