Pharma companies implement lean six sigma practices for reducing operating costs and offer the best products to customers. It also enables companies to optimize cost, fix quality and regulatory compliance issues, and improve operational efficiency. Also, integration of traditional lean methodology six sigma with data collection and root cause analysis tools can bring benefits to the companies.

To reduce the counterproductive steps in an operational process, pharma firms implement lean six sigma practices. Pharma companies may make use of lean tools such as 5S which are sort, set-in-order, shine, standardize and sustain to keep workspaces in order, mapping the value stream for identification of wastes and waste resources, Gemba to spot defects in process and Kanban to optimize inventory.

Pharma firms may often use the well-known Design, Measure, Analyze, Improve and Control (DMAIC) framework. This framework enables companies to minimize defects in processes. The first phase which is Define is related to goal analysis and simplification of new customer demand or business objectives. The Measure is a crucial step that focuses on the collection of quantitative and qualitative data from participants involved in the business processes. The Analyze step finds out the root cause of the problem and solution for the same, which are then used to establish next necessary actions and procedures. This can be process validation, equipment up gradation and employees adaptability. And the Control step guarantees that the changes made in processes are sustainable.

How does DMAIC Look like in a Pharma Company?

For much easier understanding let’s take an example of a tablet 

Define: It is a phase of on-time identification of the problem in the product. For example: How does metal enter a tablet? What’s the toxicity level of metal? 

Measurement: Hereby measurement, we mean measurement of the process. For example Testing of raw material, Process to find unwanted materials in a product.

Analyze: It is related to the root cause of the problem. For example: What causes the change in color of the product?

Improvement: Changes made after the analysis for further improvement

Control: Process capability index at the initial stage of the process

Hope it brings more clarity to you.

What are the Goals of 6 Sigma?

-Improve Customer Satisfaction

– Enhance Competitiveness

– Transform company culture

– Reduce defects

– Variation control and improvement in predictability

– Reduce costs without unwanted consequences

– Improvement in performance

– Reduce time to market and process cycle time

– Optimize human and equipment need

– Boost end to end process management and measurement

What are the Features of 6 Sigma?

– Elimination of waste and efficiencies which result in customer satisfaction by meeting customer expectation

– It is a strictly structured methodology, which is specific for few participants

– 6 sigma is a statistically data-driven methodology that requires accurate or error-free data for process analysis purpose

– It put results on financial statements

– It is a multi-dimensional structured approach:

• Process Up-gradation
• Decrease in defects
• Diminish variability from the process
• Diminish costs
• Extend Customer Satisfaction
• Widen profits

What is Lean?

 Lean is a way to deal with elimination of activities that don’t increase the value of the process. It has 5 principles:

-Identify what customers’ value from a particular product

– Map the value stream for each product

– Create value flow to customers without interruptions

– Enable the customer to get value from the manufacturer

– Strive for perfection

So lean is related to the efficiency of the business by reducing misuse of resources. And six sigma is an approach that limits blunders from the processes and brings improvement. The combination of both is known as Lean Six Sigma which makes the business more growth driven.

Connection between Lean and Pharma

Lean has mainly two goals: to eliminate waste and establish value while Current Food Manufacturing Practices (cGMP) goal is to ensure that controls are in order to deliver the best product. In the Pharma industry, it is seen that both sometimes overlap with each other. So the effectiveness of lean management concepts should be organized.

Pharma business goals could be achieved if lean principles are embraced and adopted in the organization.

How to Implement Six Sigma in Pharma?

To implement LSS, instead of sticking with workflow analysis, pharma companies must use algorithms for changing the mindset. This can be done by appointing those who have a better understanding of the customers and know how to exceed and meet their expectations. LSS should focus on the visualization of the process for building a framework that can meet business goals with less ambiguity in decision-making. Involving employees in the LSS shift can help companies reduce error and highlight the importance of key customer values. With support from upper management, on-time communication, interlinked activities and goals to key performance indicators pharma companies can implement LSS.

Listed below are few more strategies to implement six sigma in pharma

– When upper management is convinced for the implementation of lean six sigma, a progressive method of doing clinical trials can be brought in with the implementation of integration drive

– Integration of technologies and workflow improvement 

not possible with redundant technologies and in-house process improvement methodologies

– Give already proven research approaches for the quantitative assessment of clinical development and process improvement, the sum of which associates with solid performance 

– Six sigma in the pharma manufacturing industry

The six sigma quality improvement welcomes continuous improvement in business. The implementation of six sigma business will require interoperable, modernized and flexible systems that will allow easy flow of information across the entire department of a pharma company.

Within the pharma industry, quick interpretation of data is one important aspect of six sigma. Accessibility to data as early as possible will facilitate quick response and evaluation to FDA inquiries.

Key Characteristics and Success Criteria

There are four characteristics which form the basis of lean 6 sigma.

-Customer satisfaction by producing a quality product and quick delivery

-Process improvement by increasing flow while decreasing variation and defects

– Decision-making based on facts and data

– Make use of staff to increase cross-functional teamwork

Why Implement Lean Six Sigma in Pharma? 

Develop Better Product

Implementation of Lean Six Sigma (LSS) can also combine scientific processes with statistical methods to improve the process cycle. Lean processes do this effectively by finding out the redundant procedures.

Value stream mapping for prioritizing improvement can separate valuable and non-valuable areas for you, which later can be adjusted according to your business goals. Lean processes also reduce process time with less resources and minimize defects, malfunctions and errors. LSS implementation can bring in faster cycle times which also optimizes inventory. 

Reduction in cycle time along with process mapping can help pharma firms in becoming first to Market Company. In terms of Research and Development (R&D), LSS can reduce the cost of production for research and clinical applications, increase output and bring innovation. This level of increase in productivity helps the pharma business develop promising products.

Quality Improvement 

Lean Six Sigma effectively reduces the frequency of defects in products. This is quite helpful from a research and development perspective because there are variations in biological systems which need to be considered and quantified in drug development. Any small differences due to variation can result in unwanted output. LSS can adjust for errors and use case variations with the integration of statistical methods and tools to reduce the number of errors and highlight shortcomings.

Six sigma can help highlight issues present in a pharma product. This could be variation in weight, inefficient technology transfers or other factors related to manufacturing and product development. Also, value stream mapping can reduce the operational costs, by taking a detailed view of formulation and quality.

Accelerates Growth

On-time identification of failures and appreciating productivity, Lean Six Sigma can work within the pharma operations, especially in Research & Development (R&D). The use of LSS is not only limited to the discovery of process, clinical trials and PAT applications but can also be used in the development pipeline which streamlines upstream and downstream processes. LSS implementation can convince all the parties involved in it. It also brings benefit to patients, physicians, specialist doctors, healthcare providers (HCP) and pharmacists by bringing much-needed changes in quality, cost and service.

Summing Up

Lean is an approach to meet the need for reduction or elimination of errors such as loss of time, unplanned product production and use of technologies that make no sense. And six sigma is an approach for process improvement and also a concept that characterizes the variation in the process. Integration of both can bring in customer satisfaction.

If you feel it’s time to market faster, engage more with your internal and external stakeholders by implementing LSS. The payoff is massive.

You can go through the certificate associated micro-course on Basics of Lean & Six Sigma Methodology.