Operational Excellence in Pharma Manufacturing with Lean Six Sigma

While pharmaceuticals are a booming sector, in this increasingly competitive economy, companies have to constantly improve their manufacturing efficiency to be profitable and capture a larger share of the market. Digital transformation and the adoption of IoT solutions are necessary, but none of these can succeed without paying attention to the underlying processes. Many pharmaceutical manufacturers suffer from a lack of process information with no clear visibility into what’s really happening at all levels of the company, especially on the factory floor. Process management is what distinguishes the market leaders from those who lag behind. While quarterly targets might seem like an area of focus to quickly increase revenue, short-term goals do not necessarily set up the business for sustained long-term success. However, if the focus shifts to improving processes, you can also expect to see consistent success in achieving goals as your organization focuses on the factors that affect the eventual outcome. While there are many process management principles pharma manufacturers can follow, one of the most effective methodologies that has seen success across industries, including the manufacturing sector, is Lean Six Sigma. What is Lean Six Sigma (LSS)? Also referred to as LSS, Lean Six Sigma is a combination of two process management strategies: lean and six sigma. Lean manufacturing has its roots in the Japanese manufacturer Toyota’s production system. Their philosophy focused on reducing wasteful or redundant activities and improving workflow to draw more value from what you do. Eliminating waste and improving customer experience were the core of their thinking, and from that, lean manufacturing evolved as a way to increase speed. Six Sigma aims to improve process quality through statistical analysis that helps identify and eliminate defects, along with reducing variation in process outputs. The defects are actually process outputs that do not meet the customer specifications, a type of quality check. According to the six-sigma process, defects can be reduced by reducing the number of steps involved. This can be done through cause-and-effect analysis done by tracking the 6Ms. The 6Ms of Six Sigma are: Method: specific regulations or policies causing a slowdown Mother Nature: environmental factors affecting the production Manpower: training new people Measurement: accuracy of the equipment used to take readings Machine: maintenance issues or availability of equipment Materials: issues related to sourcing and transporting raw materials Together, Lean Six Sigma and manufacturing can be a powerful way to achieve operational excellence. Lean’s speed combined with Six Sigma’s speed overcomes the weaknesses of both methodologies, providing a complementing system that can be easily implemented in pharmaceutical manufacturing. Applying Lean Six Sigma to Pharmaceutical Manufacturing Lean Six Sigma initiatives are not new to the pharmaceutical industry. However, as they have lost their novelty and there is a lot of misunderstanding around the purpose of the methodology, it is still not widely implemented, and many companies have yet to experience how it can improve their pharma manufacturing process. Benefits of Lean Six Sigma in Pharma Manufacturing Here are how the two main benefits of Lean Six Sigma affect pharmaceutical manufacturing: Increased Speed Lean Six Sigma can be used to increase R&D productivity as well as speed up the production process. With a faster cycle time, pharmaceutical manufacturers can be the first to market and deliver products to their customers quickly. Improved Quality By standardizing processes through Lean Six Sigma, the variations in the drugs across batches can be reduced, and overall quality can improve. It can thus help reduce operational costs as you examine factors affecting formulation and quality closely, eliminating any wasteful activities that do not positively contribute to this. There are also recent applications of Lean Six Sigma that show that this methodology continues to be relevant and can yield great results. A 2021 study examined how a single pharmaceutical manufacturing company producing acetaminophen (paracetamol-containing pain relief) tablets used LSS to match the increased demand due to the pandemic. Operational excellence was achieved by using the toolset provided by this methodology to determine root causes and implement corrective actions. Problems were eliminated without negatively affecting manufacturing cost, production time, or product quality. The result was a reduction in downtime, improved product flow, the elimination of product waste, increased productivity, and an enhanced customer experience. This shows that Lean Six Sigma can help pharmaceutical companies achieve excellence, even in modern operations. Implement Lean Six Sigma with EviView As an award-winning Lean software provider, EviView has developed a one-stop solution for the process management needs of pharmaceutical manufacturing. Our tool helps your team seamlessly capture any delays categorized by the 6Ms (man, machine, material, method, measurement, and management) so you can adopt the Lean Six Sigma methodology. Book a call with us today to learn more about how you can achieve operational excellence.
Tracking and Improving Production Performance with EviView

Manufacturers have faced considerable production difficulties in recent years. As supply chains are disrupted, workforce dynamics change, and consumer demands evolve, manufacturers look for ways to optimize production efforts. Analyzing production data to identify patterns across the prevailing business landscape is one of the best ways to find optimization opportunities within a company. Manufacturers are leveraging data analytics to understand the forces influencing their operations and improve processes. Therefore, manufacturers have been increasingly investing in new digital solutions that help them gather more data from their business operations. With this, manufacturers can gain insight into how their machines function and adjust for optimum results. In this post, we explore some of the most common challenges plant leaders face and how you can leverage EviView business intelligence software to streamline data collection and draw more meaningful insights from your operations. Tracking the performance of plant operations A plant manager must know and understand the state of his plant’s performance to make better and more timely decisions. Unfortunately, most business leaders need more data they consider valuable. Despite this, they still need to track critical aspects of their operation and monitor performance trends to optimize decision-making as quickly as possible. Companies are also dealing with a shortage of skilled analytical professionals, making it exceedingly difficult for people outside their organization to understand and solve problems within their operations. This has led to a situation where many plant managers need to be more under- and over-managed. They need more information than they can access, but they also don’t want too much information because it can be overwhelming. They often feel like they’re fighting an uphill battle against their organizations, which makes sense considering that most companies lack the necessary tools to analyze operations data. Manufacturing challenges faced by plant leaders Manufacturing is a tough business, and plant leaders face several daily challenges. Here are some of the most common: Inefficient processesManufacturing companies are always working to improve their processes. They’re always looking for ways to improve efficiency and reduce costs, so manufacturers have a lot of data to analyze. The problem is that this data is often difficult to understand, which makes it hard for plant managers to know what’s causing problems or where they need to focus their attention. Poor data integrityData integrity is a big issue in manufacturing. The issue is that there are many data sources that may not always be accurate or up-to-date. For example, if you’re using an ERP system to keep track of sales orders and shipments but your shipping department has its own way of recording information about customer shipments, it’s easy for errors to creep into your data. Burdensome validationValidation is another big issue in manufacturing. You might have a lot of different applications that are all trying to get data from various sources into one place, but more is needed to ensure accuracy. You also need to ensure that the data you’re getting is accurate by validating it against other production monitoring systems or manually checking for errors. Unplanned deviationsIf you’re trying to automate your operations, it’s important to remember that there will always be unplanned deviations from the norm. The most obvious example is when a worker gets sick or injured, but other circumstances can cause problems. For example, if your equipment breaks down unexpectedly, it could throw off your schedule and create issues with production. Low in-process visibilityIn-process visibility refers to how well you can see what’s happening in each stage of your production process. If you have good visibility into the steps being performed, it can be easier to make changes when issues occur. This is especially true if one step relies on another to be completed before it happens, so if something goes wrong in the first stage, then there may not be anything that can be done about it until later (by which time it might already be too late). Delayed releaseDelayed releases are a common problem in manufacturing because they can cause other parts of the process to fall behind, leading to more delays and even worse quality problems. If you’re waiting on materials or other inputs from suppliers that need to meet your deadlines, it will throw off the entire schedule and create issues with production. Leveraging EviView for your plant operations EviView’s mission is to empower manufacturing monitoring with smarter, more effective manufacturing production tracking software for KPI tracking and reporting. We understand that the manufacturing industry is full of complex processes and production monitoring systems, making it difficult to get a clear picture of your plant’s performance. Behavioral change via continuous improvemente-ConnX makes it easy for operators to put forward CI Ideas as part of the shift handover—when they see their proposal in action, they’re more motivated. Continuous Improvement ideas can be submitted, reviewed, and plotted on the P-I-C-K chart. The more submissions employees make, the higher the chance of time and cost savings for a company. CI KPIs, such as average time to respond, review, and implement, are available in the module. Stakeholders can track the status of any actions originating from CI submission to implementation. Monitor issues efficiently with real-time data.EviView provides manufacturers with a view of their plants’ operations—a holistic, real-time look at key metrics that helps find bottlenecks, deviations, and downtime quickly. When a plant manager is notified of an issue or deviation, they can identify potential problems and prevent downtime by issuing early warnings to operators. It’s easy to monitor performance as it tracks all units minute by minute. Downtime and OEE scores can be seen for individual production lines as well as for the entire plant on a single screen in real-time. Data visualization for easier identification and quick resolutionEviView Analytics unlocks the power of your data to provide actionable insights that drive business-critical decisions. Using Fishbone, Ishikawa, Pareto, Waterfall charts, etc., clearly identifies which factors are the primary contributors to downtime events. When reporting downtime occurrences, operators can easily categorize and distinguish between issues caused