Operational Excellence in Pharma Industry
•
6 likes•2,799 views
The document discusses operational excellence (OPEX) in the pharmaceutical industry. It traces the evolution of OPEX from earlier continuous improvement approaches beginning in the 1940s through its adoption and increasing implementation in pharma since the early 2000s. Key drivers for OPEX in pharma included financial pressures, FDA expectations for improved manufacturing processes, and the need to enhance competitiveness. By 2013, over half of pharma companies had implemented OPEX in at least some manufacturing plants. The document outlines best practices for sustainable OPEX implementation, including effective management systems, project governance, communication, and people focus.
Recommended
Recommended
More Related Content
What's hot
What's hot (20)
Similar to Operational Excellence in Pharma Industry
Similar to Operational Excellence in Pharma Industry (20)
Recently uploaded
Recently uploaded (20)
Operational Excellence in Pharma Industry
- 1. OPERATIONAL EXCELLENCE IN THE PHARMA INDUSTRY 4/35
- 2. 1 2 3 OPEX in Pharma Best practices Overview of OPEX 5/35 CONTENT
- 3. 1. OVERVIEW OF OPEX… 6/35
- 4. No clear-cut definition, think of it as answering the question: Where will our journey of continuous improvement take us?.. WHAT OPEX REALLY IS ? 7/35
- 5. A good answer is that.. “Our journey will take us to OPEX, or to the point at which each and every employee can see the flow of value to the customer, and fix that flow before it breaks down” 8/35
- 6. OPEX Began as a revolution ... 9/35
- 7. Automation & Computerization BPR Just-In-time TQM 1940s – 50s 1960s – 70s Late 90s 1980s 1990s … then evolved Only LSS goes beyond the traditional continuous improvement methods to a long-term change in organizational culture. Lean Six Sigma 10/35
- 8. OPEX combines the 2 earlier continuous improvement methodologies … “Waste & Variation add cost and lead to Customer Dissatisfaction” 11/35
- 9. Focus on the Customer (VoC) Understand how the work gets done (Value Stream) Smooth the processes and remove waste Manage by facts and reduce variation Make value flows at the pull of the customer Involve, align and empower employees Undertake improvement activity in a systematic way LSS PRINCIPLES… 12/35
- 10. Culture (Values/ Leadership) Tools (Lean/ 6Sigma) LSS Customer KEY ELEMENTS OF LSS … 13/35
- 11. 2. OPEX IN PHARMA … 14/35
- 12. 199X Pre-OPEX 200X Best Practice Transfer 201X Transformation Integrated OPEX 15/35 OPEX EVOLUTION IN PHARM…
- 13. At the end of 2001… • Industry faced financial pressures. • FDA received numerous post-approval changes. Industry & FDA realized, it is the time to look inward & improve manufacturing processes INTERNALLY. START OF OPEX IN PHARMA 16/35
- 14. THE DESIRED STATE… Aug. 2002, FDA announced its BOLD new vision for pharma manufacturing, termed it “The desired state”: Product quality and performance assured by design of effective and efficient manufacturing processes. Product specifications based on mechanistic understanding of how formulation and process factors impact performance. Continuous improvement approaches, with innovative use of new technology as desired. 17/35
- 15. 2003, Drug companies started to look at innovative ways to make manufacturing more Competitive (Efficient & Agile) to face the arising pressures. THE SURVIVAL STRATEGY… 18/35
- 16. Lean Production Six Sigma Process Analytical Technology (PAT) Quality by Design (QbD) NEW STRATEGY INITIATIVES… 19/35
- 17. Pharma Manufacturing Waste in 2006 exceeded $50 billion 20/35
- 18. OPEX IN PHARMA BY 2013… 11% 56% 33% Has not been implemented Implemented in pilot areas Comprehensively implemented in some plants Comprehensively implemented in all plants 0 21/35
- 19. 3. BEST PRACTICES FOR OPEX SUSTAINABLE IMPLEMENTATION … 22/35
- 20. EFFECTIVENESS BEFORE EFFICIENCY Preventive maintenance OEE Monitoring Effective Technology Usage House-keeping TPM Process management Customer integration Cross- functional product development Supplier quality management TQM Stable equipment Stable process Stable replenishment OperationalPerformance Set-up time reduction Pull system Planning adherence Layout optimization JIT Effective Management System • Management commitment • Company culture • Employee involvement • Functional integration 23/35
- 21. SELECT THE RIGHT PEOPLE 24/35
- 22. TAKE CARE OF PROJECT GOVERNNCE 25/35
- 23. GIVE STRUCTURE & RESOURCES TO THE PROGRAM 26/35
- 24. GET MANAGEMENT COMMITMENT ON PLANT LEVEL 27/35
- 26. CONTROL THE SUCCESS OF THE PROJECT 29/35
- 28. UNDERSTAND THE PROGRAM AND ITS LINK TO STRATEGY 31/35
- 29. CELEBRATE RESULTS WITH EVERYONE IN THE COMPANY 32/35
- 30. KEY TAKEAWAYS 33/35 The best plant is the cheapest to Run, Not to build. Being lean is not more important than providing customer value, (Angry customers leave). Plant Reliability is vital to Market Availability. OPEX creates new Capacity without Capital spending. Culture should drive Performance. Believe and Invest in people. Engage shop floor and give them time to think. Create a people advantage (Rewarding). Complexity is the leadership challenge: find it, eliminate it and prevent it.
- 31. SOURCES: 34/35 Porsche consulting, survey 2013 “Operational Excellence: Pharma’s Missed Opportunities” article / 2009. By Thomas Friedli, University of St. Gallen and Prabir Basu, Director, NIPTE. “The evolution of Operational Excellence” article. By Thomas Friedli, Christian Mänder and Prabir Basu
- 32. BACKUP SLIDES
- 33. QbD … “A systematic approach to development that begins with predefined objectives and emphasizes product and process understanding based on sound science and quality risk management” ICH Q8R, Annex to ICH Q8: pharmaceutical development
- 34. PAT … “A system for designing, analyzing and controlling manufacturing through timely measurement (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality” definition in ICH Q8: pharmaceutical development
- 35. Porsche consulting, survey 2013
Editor's Notes
- © Copyright PresentationGo.com – The free PowerPoint template library
- Think of it as answering the question: Where will our journey of continuous improvement take us? A good answer is that our journey will take us to Operational Excellence, or the point at which — Each and every employee can see the flow of value to the customer, and fix that flow before it breaks down.SM Why This Definition Works By defining Operational Excellence in this way, it applies to every level and every person in the organization, from executives all the way down to the employees producing the product. It’s clear, concise, practical and, most importantly, actionable and teachable. Everyone in the organization “gets it.” They know that, in their respective areas, there should be a visible flow of product or information. They should be able to recognize if that flow is normal or abnormal and what to do if it is abnormal, all without requiring the assistance of management. With this definition of Operational Excellence, we can begin to teach the true power of lean value streams by taking them a step further. We can now create value streams that not only flow at the rate of customer demand, but are made visual in such a way and to such a degree that every employee in the organization can physically see that flow.
- © Copyright PresentationGo.com – The free PowerPoint template library
- 1- Listening to VoC will help you in identifying the CQA. Measuring and monitoring the CQA will help in improving the performance and retaining customer satisfaction. 2- Value stream describes all of the steps in your process – for example, from a customer order to the issue of a product or the delivery of a service, through to payment. By drawing a map of the value stream, you can highlight the non-value-added steps and areas of waste and ensure the process focuses on meeting the CTQs and adding value. To undertake this process properly, you must ‘go to the Gemba’. The Japanese word Gemba means the place where the work gets done – where the action is – which is where management begins. Process stapling involves you spending time in the workplace to see how the work really gets done, not how you think it gets done or how you would like it to be done. You see the real process being carried out and collect data on what is happening. Process stapling helps you analyse the problems that you want to tackle and determines a more effective solution for your day-to-day activities. The value stream reveals all of the actions, both value-creating and non-value-creating, that take your product or service concept to launch and your customer order through the supply chain to delivery. These value-creating and non-value-creating actions include those to process information from the customer and those to transform the product on its way to the customer. 3- Improve process flow and remove waste 4- Managing by fact, using accurate data, helps you avoid jumping to conclusions and solutions. You need the facts! And that means measuring the right things in the right way. Data collection is a process and needs to be managed accordingly. Using Control Charts enables you to interpret the data correctly and understand the process variation. You then know when to take action and when not to. 6- You need to involve the people in the process, equipping them to both feel and be able to challenge and improve their processes and the way they work. Involving people is what has to be done if organisations are to be truly effective, but, like so many of the Lean Six Sigma principles, it requires different thinking if it is to happen. 7- Undertake improvement activity in a systematic way. DMAIC of Six Sigma comes into play here. Tackle problems in bite-sized chunks and never jump to conclusions or solutions.
- Introduce the Three Major Elements of Lean Sigma:- only as a recap if the ‘SixSigma’ advocate training day has already been delivered to the attendees These three interlocking circles represent the three elements of Lean Sigma; Customer, Tools and Culture. “The area in the middle, where the circles overlap, represents Lean Sigma. Lean Sigma requires all three circles. “In the ‘Tools’ circle, you’ll notice Lean and Six Sigma, the two fundamental methodologies of Lean Sigma. In fact, while we call them ‘tools,’ we’ll approach them as methodologies. They are most powerful when they are used together to reduce waste and variation. “The Culture circle identifies values and leadership. That’s what culture is based on; our shared values, and the leadership behaviour that we exhibit. This is fundamentally about what we believe, and how we act. “The ‘Customer’ circle embodies that all we do must start with the customer; what does the customer want, and what will the customer pay for? Without a clear definition of customer, we are applying our methods and changing our culture, perhaps for the wrong reasons.”
- Pre-OPEX: it’s all about cGMP In the late 1990s, pharmaceutical production was determined by one central force: the regulatory framework, predominantly based on cGMP guidelines. While compliance and finished product quality were the credo of pharmaceutical manufacturing, other practices to improve efficiency and flow were deemed irrelevant to or even incompatible with cGMP. The final product quality might well be excellent, but it was not based on well-understood and efficient processes (6). In fact, pharmaceutical manufacturing was characterized by a high number of rejected batches, lengthy laboratory tests, an extraordinarily high number of inspections and slow feedback loops for subsequent batches (5). Best Practice Transfer: isolated OPEX applications At the beginning of 2000, increasing cost pressure, the awareness of inefficiencies in the manufacturing area and the aforementioned regulatory initiatives prompted individual manufacturing sites to start experimenting with performance improvement tools, mostly originating from programs such as Six Sigma, Lean or Technical Performance Measurement. The main purpose was to increase efficiency by “doing things right first time”. This OPEX phase is characterized by individual projects dealing with specific tools and practices, guided by experts or external consultants (5). The focus was on tools, not people. Transformation: company-wide initiatives and programs What became obvious during the best practice transfer stage was that ideas often stalled, leading to missed opportunities. The approach was too technical and neglected the impact of the people involved in the processes. What was needed? Well, active engagement from top management, changes to the organizational setup and a change management program that actively engaged every single worker in the plant. With these missing pieces in place, sustainable implementation of pharmaceutical OPEX programs was finally possible. Integrated Operations System: beyond the tools How can companies reach the fourth and final stage of OPEX evolution? We believe there are a number of crucial aspects (5): The many different initiatives in leading pharmaceutical companies should be bundled into an umbrella program, aligning all key activities for improvement of operational competitiveness. New and improved practices will be developed and implemented. These practices will be generated internally, so they will rely on effective sharing of knowledge across the organization. OPEX will not be limited to practices and standard routines. The mindset to affect change and make improvements should prevail on all levels of the company. OPEX and performance should be seen in a wider context, and not be confined to the boundaries of an organization. OPEX will be integrated with quality management. The modern approach to quality is systems oriented, just like the OPEX program. Therefore, a properly planned and executed OPEX program should also be a measure of the effectiveness of the quality systems. On the other hand, overzealous OPEX programs could negatively impact quality. Finding a way to tackle this challenge is one of our key areas of research right now. In the future, OPEX and quality will not be two separate discussions.
- Patent expiration, generic competition, counterfeiting, and supply chain challenges are all having an enormous impact on manufacturing, and companies are looking at ways to improve. Globalization and the rapid emergence of developing economies are acting on pharmaceutical companies as well, forcing them to develop strategies to become more competitive.
- Both the industry and the FDA were well aware of the deficiencies in pharmaceutical manufacturing, and knew that to move forward they must encourage the use of innovative technologies to enhance process understanding and establish scientific, risk-based approaches to quality and regulatory processes. The FDA and the industry assembled a process analytical technology (PAT) Team to evaluate how they could further promote this concept. The PAT Team and Manufacturing Science Working Group agreed that things had to change: “Pharmaceutical manufacturing operations are inefficient and costly. The cost of low efficiency is generally not understood or appreciated (e.g., manufacturing costs far exceed those for research and development operations). Low efficiency is predominantly due to ‘self-imposed’ constraints in the system (e.g., static manufacturing processes, focus on testing as opposed to quality by design, approach to specifications based on discrete or the so called ‘zero tolerance’ criteria, a less than optimal understanding of variability, etc.). These constraints keep the system in a corrective action mode. Continuous improvement is an essential element in a modern quality system and it aims at improving efficiency by optimizing a process and eliminating wasted efforts in production. In the current system continuous improvement is difficult, if not impossible (1).” In response, the FDA shifted from its position of focusing on product purity and potency as its measure of quality, towards a regime that focused on the actual physical manufacturing processes (2). The idea was that a more thorough understanding of the processes would lead to more predictable and efficient manufacturing. In August 2002, the FDA announced a significant and bold initiative: Pharmaceutical cGMPs for the 21st Century. The aim was to encourage the early adoption of new technological advances by the pharmaceutical industry, to base regulatory review and inspection policies on state-of-the-art pharmaceutical science, and to facilitate the use of modern quality management systems. Risk-based approaches would focus both industry and agency attention on critical areas and incorporate enhanced quality system approaches into the agency’s business processes (3).
- To survive, drug companies (big pharma in particular) have had to look at innovative ways to become more efficient and agile at manufacturing, in other words to be more competitive, and to embrace the change that is permeating the industry.
- Our data provides evidence that if an operational excellence initiative first tackles effectiveness issues and only thereafter shifts its efforts to increase efficiency; the program is much more likely to succeed than if it’s done in the reverse order. Unfortunately, this does not always reflect the interests of Senior Management in every company. As the big savings come with the efficiency driven parts of the programs, such as Lean Manufacturing, some of them are focusing on efficiency right from the beginning. These programs are likely to fail in the long run, since at the end of the day, no sustainable success beyond some initial gains will be achievable. To achieve a high JIT Performance, a stable underlying system comprising the equipment and the processes in place is first required! A closer look at a sample revealed that the best performing companies in the Just-in-Time category (this category comprises KPI’s like inventory turnovers, throughput time, set-up time, etc.) have at the same time a significantly higher performance concerning Total Productive Maintenance (TPM) and Total Quality management (TQM) than the rest of the sample
- Improvement projects in Operational Excellence usually require the working together of cross-functional teams. The challenge in achieving results is mostly not a methodological or a technical one but a management challenge. The key capability for successfully completing a let’s say 6 sigma black belt project is management! This means that one has to select people as team leaders, yellow, green or black belts that have management capabilities. Without this, one will not see any return from the projects. This means that one faces a certain trade-off as the same people are needed to run the day-to-day operations too.
- All too often, the implementation phase is where improvement projects die a quiet death. In the face of shifting priorities, resource scarcity and disputes between departments, improvement projects can end up delayed, cancelled or even worse – rewritten to such a degree that they have nothing to do with the original idea anymore. The successful implementation of improvement projects requires: An effective process for capturing project goals and deliverables and estimating their costs and dependencies An effective selection process for projects to avoid having too many ongoing projects at the same time Full support of higher management to sort out interfering priorities and departmental issues Full personal accountability from all the members of the project team to bring the project to a good end
- In the beginning, there is a strong need for a support organization in each plant to help start Operational Excellence. Somebody at the plant has to be the coordinator of all activities related to improving operational excellence. He has to coach ongoing activities and has to ensure that there is a close link to the plant leadership team. Without a dedicated leader for operational excellence on the site level, the efforts will usually only have limited success.
- The site manager faces tremendous pressure in today’s business landscape struggling with low cost competition in- and outside the company. Usually they have to deal with a lot of different initiatives at the same time such as PAT, QbD, Six Sigma, Lean Production, etc. In order to obtain management commitment, it is mandatory to explain and manage Operational Excellence as an umbrella initiative helping to structure all other things going on. This will ensure that the site management understands that striving for Operational Excellence will remain as an objective even when one of the sub-initiatives takes a break. This understanding will help to get a site management commitment for Operational Excellence and give orientation to the whole plant. A common misunderstanding is e.g. to believe that Operational Excellence is something that starts in the plant! Preventive methods like QbD ensuring that a process is well designed from the beginning are also part of Operational Excellence.
- Communication to the shop floor about operational excellence is an important factor in getting a commitment of each single employee to continuous improvement. At the launch of the program, the communication will be about the basic idea, the business logic, the number of started improvement projects etc. As time goes by, the character of communication has to change. People will want to see the success of the activities, the gains achieved, and the improvements in their operations.
- It is an old saying that “what gets measured, gets done! Therefore what is needed is to establish some simple KPI’s showing that the program is running and is achieving results. KPI’s could be number of running projects, number of projects in the pipeline, cancelled projects, projects on hold, achieved savings, people trained,etc.
- Most important is like in many other change programs that you can not change when you’re not systematically involving people in this change. Most of the success factors discussed here, help to make people engaged in the required changes. One can not order continuous improvement from the top! Operational excellence is a people’s business.
- To get a buy-in on all levels in an operational excellence program it is mandatory that people understand the meaning and the objectives of the program. The objectives have to be linked to the overall strategy of the company and the site. This will ensure that the program is seen as improving the survival and the competitiveness of the plant and not simply as a “pain in the neck”!