Operational excellence is a philosophy designed to deliver better results for customers and patients. Through technical and behavioral changes, operational excellence enables service providers to avoid delays and deviations. Fulfilling orders on time in full ultimately benefits patients by supporting the timely development and delivery of life-changing medicines.
In the pharmaceutical manufacturing industry, operational excellence can encompass an operating system, production infrastructure, and a mindset and behavior capability that help build the platform for change. Companies that embrace the philosophy develop cultures of continuous improvement that enable them to create value for customers and patients.
Piramal Pharma Solutions (PPS), a contract development and manufacturing organization (CDMO), sees operational excellence in the context of its focus on patient centricity, customer centricity, and its values as a company, notably its goal of “Doing Well and Doing Good.”
PPS' pursuit of operational excellence is intended to help it optimize its capacity, solve its customers' problems, and deliver projects on time and in full. By creating value for customers, PPS also furthers its patient centricity agenda by ensuring medicines get to the people who need them, when they need them.
Pairing operational excellence to Quality-by-Design (QbD) creates further value for customers and patients by supporting the acceleration of drug development. CDMOs need people with the skills to deliver QbD and the mindset instilled by operational excellence to support the acceleration of the development cycle. PPS has made a concerted, global effort to build such a workforce.
PPS has created the Piramal Pharma Operating System to advance its operational excellence strategy. The PPS operating system is focused on the 3Cs: Customer, Capacity, and Capability. PPS visualizes its operating system as a house. Cultural building, behavioral leadership, and safety and sustainability form the foundation of the building. The foundational elements sit just below a layer featuring tools like 6S, visual management and standardization, and asset reliability. Visual management helps PPS organize things properly at each of its sites and drive on-time project execution.
Pillars of efficiency and quality sit atop the foundation. The efficiency pillar features elements such as capacity enhancement, process improvements and yield. The quality pillar covers effective problem solving, something PPS ensures through its use of tools such as 5 Whys, an iterative interrogative technique for exploring the cause-and-effect relationships at the root of a difficulty, and fishbone diagrams that help determine why an issue is happening.
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By combining those elements of the operating system with operational leadership, automation, people engagement, and digitalization, PPS has created a model that drives its focus on patient centricity, customer centricity, and knowledge, action, care, and impact.
The system is based on the Malcolm Baldrige Model, a well-established framework that provides a way to identify factors that are critical to the management and performance of an organization. No two organizations that use the Malcolm Baldrige Model will have the same experience. The insights the model delivers are as unique as the organizations themselves. At PPS, alignment to the model led to an operating system that gives the global leadership team a way to promote performance excellence and learn and share practices, principles, and strategies that drive operational excellence.
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PPS'; employees feature in the operating system and are supported by activities such as training and reward recognition. Operational excellence training starts at the onboarding of new employees. Through the Piramal Learning University and a commitment to the principles of the Kaizen business philosophy, PPS ensures the continuous improvement of the capabilities of its staff.
All employees complete Six Sigma White Belt, ensuring every staff member is able to help with change management and contribute to local problemsolving teams. Over the first 10 months of its 2020-21 financial year, PPS conducted more than 30 White Belt training sessions around the world, leading to the certification of almost 1,000 people split evenly between sites in India and the rest of the world.
PPS is building on the success of the White Belt training program. Upon the recommendation of their managers, employees can train towards more advanced belts such as Yellow and Green Belt programs. Those more advanced certifications will equip PPS'; workers to plan projects effectively, analyze variations efficiently, and rectify business productivity. PPS will start Black Belt training in the next fiscal year to create a cadre of experts in Six Sigma.
The global nature of PPS'; Six Sigma training program is part of a broader effect to ensure all parts of the business benefit from and contribute to operational excellence. Through the Ideas to Excellence initiative, any PPS employee, at any site, can submit a proposal for how to improve operations. The third volume of the initiative identified 451 ideas from across PPS'; nine sites.
PPS used a digital platform and virtual workshops to gather ideas for the third volume, before using a project hopper to assess the feasibility of the suggestions and prioritize them. PPS has implemented more than 100 of the ideas and given rewards and recognition to the people and departments who came up with the proposals.
Involving all sites in the operational excellence agenda enables ideas to spread. PPS held a North American Operational Excellence Summit early in 2020 to set out its operational excellence strategy, review progress on Ideas to Excellence, and discuss the rollout of White Belt training.
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Such summits are part of how PPS continually evaluates how different practices fit with the culture at its sites in Asia, Europe, and North America.
Evaluations of the applicability of new approaches to different regions involve the operational excellence leaders from each site, who contribute practical examples of what has worked for them and develop guidance documents that share best practices.
Employees can access the latest information on the operational excellence strategy on a dedicated website. The website contains the Six Sigma training calendar and other information employees need to stay informed of PPS'; ever-advancing operational excellence agenda.
The collaborative efforts of the operational excellence site leaders are supporting some of the raft of programs underway at PPS. This year, the creation of 6S guidelines and implementation of a related roadmap has been a priority. Having made progress on that front, PPS is now positioned to sustain and execute the implementation plan in its next financial year.
PPS is also working on a project centered on asset reliability, one of the foundational elements of its operating system. The focus on asset care and reliability has led to the development of a method for assessing the criticality of equipment. PPS is piloting the approach at a site ahead of its incorporation with global engineering. Another foundational element, visual management, is already implemented and set to enter a phase focused on practice improvement to deliver more projects on time, in full.
The details vary somewhat from site to site. At its site in Morpeth, England, PPS is working to reduce quality control cycle times and increase throughput. In Digwal, India, PPS is striving to improve yields as part of a transformation journey that is leveraging automation and mechanization, while in Riverview, Michigan, the focus is on capacity enhancement and reduced cleaning times. A global dashboard of key
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performance indicators (KPIs) is tracking PPS' progress at all sites. The KPI dashboard, which is set to gain new automation and reporting capabilities in the coming year, gives the senior leadership team datadriven insights into PPS' work to make it right the first time so there are no delays, fewer deviations, and no problems with the delivery of projects. The team can analyze the performance of global sites to inform a strategic approach to continuous improvement.
Equipped with the insights, PPS will ensure it consistently meets and exceeds the expectations of its customers. The benefits of such consistent execution extend well beyond PPS and its customers. Through its work to deliver customer projects on time and in full, PPS ultimately contributes to the swift development and consistent supply of life-changing medicines. As with everything at PPS, in the end the operational excellence strategy comes back to the key stakeholder: The patient.
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The Confederation of Indian Industry (CII) recognized the effectiveness of PPS' operational excellence strategy. At the 39th National CII Kai-Zen Competition in 2021, PPS' cGMP chemistry services facility in Ennore, India won the Platinum Award in the Renovative Kaizen category.
The Ennore facility also won the Gold Award in the Innovative Kaizen category, as did PPS' commercial manufacturing and packaging services facility in Pithampur. The significance of the awards is emphasized by the strength of competition in India, which is a key focus of Kaizen activities outside of Japan.1
References
1. India highest JIPM TPM Award Winner outside Japan. TPM Club India
http://www.tpmclubindia.org/index.php?option=com_content&view=article&id=27&Itemid=138
Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), where everything we do, we do for the patient. The company specializes in integrated services and end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe, and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process and pharmaceutical development services, clinical trial supplies, and commercial supply of APIs and finished dosage forms. We also offer specialized services like the development and manufacture of highly potent APIs, antibody drug conjugations, and manufacturing of hormonal drugs. Our capability as an integrated service provider and experience with various technologies enables us to serve innovator and generic companies worldwide. Our development centers and manufacturing sites have accreditations from regulatory bodies in the U.S., Europe, and Japan. With a pool of 700+ scientists including 150 Ph.D.s across the globe, we are committed to research and development programs.
