Lean Six Sigma Concept : Pharmaceutical Guidelines

Lean Six Sigma Concept

Six sigma helps to improve the productivity and quality of product when it is implemented in proper way in pharmaceutical manufacturing facilities. Some of the pharmaceutical manufacturing companies have implemented it.
Lean Six Sigma (LSS) is a combination of two processes that were initially applied separately to improve business efficiency and effectiveness. In a nutshell, the lean methodology is aimed at reducing or totally eliminating steps that do not add value in a manufacturing process and six sigma is a data-driven methodology aimed at producing a continuous process with low defects.

Lean Six Sigma can be therefore be simply defined as a combination of two powerful processes aimed at improving performance by eliminating waste and defects using a set of unique tools.

Lean six sigmaPharmaceutical industries such as GlaxoSmithKline started applying Lean Six Sigma in their drug development processes. Considering how expensive drug production process is, the use of Lean Six Sigma increases the chances of producing a viable drug. The use of Lean Six Sigma in statistical terms ensures that in every one million activities, only 3.4 defects or less occur. Pharmaceutical companies vary from most other companies in a few ways. One way it varies from other companies is that customers have very little say in the products they use.

The use of Lean Six Sigma has proven to be a critical part starting right at the discovery of molecules to clinical trial and even application of PAT. The use of Lean Six Sigma has reduced the timeline which a new drug is released in the market for use while having attained all the necessary requirements.

Lean Six Sigma tools used in pharmaceutical industries. Lean Six Sigma uses a combination of tools from the two merged processes. Lean tools include:
1. 5s: This is a tool used to keep the working space in order.
2. Kaizen: Its a process expedited by subordinates focused on making small improvements in the organization,
3. Gemba (Go & See): This is real-time observations of the process aimed at pinpointing the process defects.
4. Value stream mapping (VSM): Tool used to identify process waste and the causes of waste.
5. Jikoda/Autonomation: This stops production in case a defect occurs.
6. Kanban: A system which manages inventory levels and brings into attention excessive or low inventory.

Six Sigma tools;
This process uses a DMAIC framework to solve any problems. This framework contains five stages;
1. Define: In this stage, the problem is defined and project aims are listed.
2. Measure: The process data, capabilities and variables are collected and measured at this stage.
3. Analyze: The roots causes of a defect are analyzed.
4. Improve: Solutions are brought up to fix the defect and improve the process.
5. Control: A control system is put in place to assure that the improvements will hold.
Related: Implementation of Six Sigma in the Pharmaceutical Industry

Lean Six Sigma utilizes the synergized power of the combined process by working in together in a process where the variations of the process exposed by Lean are fixed by Six Sigma. This ensures a continuous cycle which makes productions cheaper and ensures customers get the product they desire.

The use of LSS in pharmaceutical industries has ensured the elimination of waste and defects in the development of drugs. This process has cut down the cost of production and has proven to be one of the most effective tools to use in this industry.

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
.moc.enilediugamrahp@ofni :liamENeed Help: Ask Question

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  1. Sir give a flow chart regarding deviation ,incident , observations.


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