Operational Excellence in Pharma Manufacturing with Lean Six Sigma

Lean Pain Points
4 mins read

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:

  1. Method: specific regulations or policies causing a slowdown
  2. Mother Nature: environmental factors affecting the production
  3. Manpower: training new people
  4. Measurement: accuracy of the equipment used to take readings
  5. Machine: maintenance issues or availability of equipment
  6. 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:

  1. 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.

  1. 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.

Written By: Joe Doyle


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