How Lean Six Sigma is helping pharmaceutical industries to grow?

Lean Six Sigma
5 min readJan 4, 2021

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The pharmaceutical industry is one of the vast and dynamic sectors with a robust profit margin. But pharma companies face challenges in stabilizing and tabulating the market in the phase of economic crisis and meeting the user’s demand for maintaining their health. Even the manufacturers are struggling to reduce the operational cost.

The pharma producers have observed with their manual cost-saving process that the product quality has dwindled, besides, there is also a huge pressure with the competition in generic. To emphasize a solid bottom line, pharmaceutical manufacturers are looking for ways to optimize resources, improve efficiency, waste reduction, and to control inventories with an increase in the operations and manufacturing process.

Pharmaceutical Industry with Lean Six Sigma excellence

The regulatory bodies including the US supported the approach of risk management by building quality into the manufacturing process and rely on the end process testing- The Progress Executive Services have launched the Lean Six Sigma for Life Science and Pharma-based Industries to tailor the companies service that will help and take care of the pharmaceutical and health care sector in improving productivity, product development, and supply chain.

Six Sigma is a disciplined approach whose main priority is to focus on business excellence, customer satisfaction and drive maximum profit by changing and improving every process in the enterprise whether it is financial, operational, or production-based. Six Sigma in addition to Lean has become the heart of this vast dynamic industry, from health care to insurance, production to sales. It not only takes care of the defects but also gives equal importance to the wastages that are incurred in the organizational processing.

The pharma manufacturers had started to focus on the changes and implemented Lean Manufacturing and Six Sigma principles which other industries have achieved a result that it proved to be the best policy to help in boosting operational efficiency and improved quality with compliance. The pharmaceutical company, GlaxoSmithKline had first implemented the Lean Six Sigma methodology in the drug development process.

Strategies to launch Six Sigma in the pharmaceutical Industry:

  1. To get accustomed to the new change and integrate the new system, i.e. taking the initiative of implementing Six Sigma into the traditional ways of conducting clinical trials by campaigning.
  2. Enforcement in meeting challenges with six sigma by focusing on the integration of technology and workflow improvements and simultaneously extend new ventures. But it is not possible using the conventional method of technology implementation or homegrown processing improvement methodologies.
  3. A qualitative evaluation technique is provided with a tested research approach of clinical development and process improvement strategies, the integration of these exclusive tools and techniques has strongly correlated with financial performance.

Let’s take a story of LSS’s efficiency in a company on the supplier and material approval process in the packaging division. The identification and the certification process of packaging materials by the suppliers take at least 12 months because of the complexity and formalities. But when the Six Sigma approach was approved and it followed 4 pilot products and aimed at the critical parts, analyzed and identified the defects in processing. Using Six Sigma methodology, there was a seamless improvement in the process streamline and it was successful in reducing the cycle time from twelve to five months and realized the significant change in savings.

DMAIC example in the pharmaceutical industry:-

A tablet is a pharmaceutical solid dosage form that contains a mixture of active and inactive substances that are natural or synthetic in a powdered form, compacted from a powder into a solid dose. So here how Lean Six Sigma will be helpful to solve any problem.

D = Define

‘Define’ tells about the defect, ‘what can be the problems’ or ‘what are the problems’. Such as what are the components in a tablet? How are components compiled in tablets? What is the toxicity level of components?

In the first phase, it is identified the defects to be aware of the problem.

M = Measurement

Here, the process is being measured, such as the weight of the tablet. How the raw material testing is being proceeded and the processes to find components in tablets.

A = Analyse

In this phase, an effort is given to understand the root cause of the problem. Such as why the components are compiled in a tablet? Why weight variations are occurring.

I = Improvement

The decisions are being applied that are taken for the rectification after the analysis phase so that no problems are reduced in the process.

C = Control

Here, it is being controlled with the capacity of process indexing from the start of every process. The sampling of tablets should be done at an indefinite interval.

Lean Six Sigma even ensures in statistical terms the defect removal or reduction in such a unique way that in every one million activities only 3.4 defects or less are detected.

Tools used by Lean Six Sigma in Pharmaceutical industries

  1. 5s- This tool takes care that the working space is in proper order.
  2. Kaizen- This process is used in making small improvements in organization processing.
  3. Gemba(Go & see)- It is the real-time observation process that aims to pinpoint the process defects.
  4. Value Stream Mapping(VSM)- This process identifies the process of waste and the root cause of the waste.
  5. Jikoda/ Autonomation- In case of any defect detection it stops the production.
  6. Kanban- The system takes care of the inventory i.e. it manages the inventory level and brings into focus the excess or deficient inventory.

The Lean Six Sigma tools and techniques have brought an extravagant result to the pharma and biotech industry in reducing the cost and eliminating waste.

To know more about KPMG Lean Six Sigma Training programme contact at +91 9555688555, +91 9022033666 or +91 8444011201.

Written by- Puja Das

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