Lean Six Sigma in Pharmaceuticals

Six Sigma is an extremely disciplined activity that focuses on growing and giving close to excellent products and services. Six Sigma focuses on what’s necessary for the client. It reduces method variation defects, so nearly all the product or services provided meet client expectations. Six Sigma has been utilized by some of the world’s most productive firms, resulting in savings of billions of dollars., speeding up processes capability, and achieving new stronger client relationships.

The pharmaceutical trade is noticing decreasing profits because of the competition from generic brands and errors in the producing method. To enhance this situation several firms try to extend potency among the producing and operational processes by reducing waste and errors.

By applying Six Sigma and Lean production, several pharmaceutical firms are able to cut back waste and convey effective amendments to the producing method. The pharmaceutical trade rules and rules are primarily concerned with the standard, safety as well as effectiveness of the product at the upper levels. 

Introduction to Lean Six Sigma

Six Sigma may be a method that may be a combination of the 4Ms that’s man, machine, materials, and methods for manufacturing products or services that meet customer’s expectations. These are evaluated by applied math strategies and should have inherent statistical variability. This method yields nearly ideal products and services.

It’s a philosophy of Quality and also the manner of surpassing accomplishment by being determinative wherever you’re and wherever you may be. At the six sigma level, there are 3.4 defects that occurred per million opportunities.

In statistics, 6 Sigma may be an approach of measure a method or a product in terms of defects and provides some way to pivot on growing and giving nearly excellent products and services. Six Sigma merely means a measurement of Quality. 6 Sigma may be a data-driven approach and methodology for eliminating defects in any method from producing to transactional and from product to service.

It realizes methods to decrease internal costs and cycle times by imparting top quality services through innovative style and economic response to the sudden increase in demand certainly products. Six Sigma was developed supported preceding Quality Management ideas like Total Quality Improvement, internal control, and nil Defects.

The methodology measures a method in terms of defects, uses statistical tools to spot the important factors that have an effect on most for raising the standard of the process and tries to eliminate defects.

Definition of Six Sigma

Six Sigma is a strategy for method improvement and a statistical conception that seeks to outline the variation in any inherent method.

Key Ideas of Six Sigma

At its core, Six Sigma revolves around a couple of key ideas:

  1. Vital to Quality: what’s necessary for the client has to be known.
  2. Defect: Failing to deliver what the client needs.
  3. Method Capability: The processes got to be able to deliver what the client needs.
  4. Variation: What the client sees and feels.
  5. Stable Operations: guaranteeing consistent, foreseeable processes to enhance what the client sees and feels.
  6. Design for 6 Sigma: the planning should meet all the client needs and also the capability of the method.

Therefore Six Sigma focuses 1st on reducing method variation and so on up the method capability.

Goals of Six Sigma in pharmaceutical:

  • To enhance client satisfaction
  • To vary organizational culture.
  • To boost the Quality of products and services.
  • Decreasing defects.
  • Dominant variation and up foregone conclusion.
  • Reduce prices – while no unintentional consequences.
  • To develop structure competencies.
  • To enhance structural performance.
  • Reducing method cycle times and time-to-market.
  • Boosting end-to-end method management and measurement.
  • Less instrumentality and humans are required.

Main Features of Six Sigma

  • It eliminates waste and inefficiency, therefore, will increase client satisfaction by delivering what the client is expecting.
  • Six Sigma is a strictly structured methodology that is extremely specific for the actual participants.
  • Six Sigma is a statistical information-driven methodology that needs correct or error-less information to absolutely analyze the method.
  • It places results on financial statements.

Six Sigma may be a business-driven, multi-dimensional structured approach for:

  • Upgrading Processes
  • Decreasing Defects
  • Minimise method variability
  • Decreasing prices
  • Extending client satisfaction
  • Widening profits.

What is DMAIC in Six Sigma

Six Sigma Methodologies all revolve around one main cycle known as DMAIC

D (Define):

The outline part is the initial part, during this section, the leaders of the project begin to know the requirements of the (clients, purchasers, and shoppers} or just what new business objective or customer demand.

M (measure):

This is the crucial step. The team focuses on information collection. At first, they need to focus on determining the beginning purpose or baseline of the method and searching for clues to know the root explanation for the method.


A (Analyse):

In this step, the team should analyze what’s causing the matter and wherever there’ll be the chance to enhance the method or service quality or price, or product. During this step, the team pays their time to discover the root causes of the downside and construct the solution as per the results.

I (Improvement):

In this step, the team should accumulate information to examine if there’s a measurable improvement or not if affirmative. Then the team can follow this method as a core method than the pilot method and so finally refine the baseline. Ultimately it ends up refining the service quality or product quality that finally meets the client’s satisfaction.

C (control):

This is the step during which the team should manage the method and sustain the changes and improvements they created within the process or service.

Example of DMAIC in pharmaceutical:

A pill may be a pharmaceutical solid dose type that contains a mixture of active and inactive substances that are natural or artificial in a very powdery type, pressed or compacted from a powder into a solid dose.

D (Define) Example:

Define section refers to what are often the issues. Like what’s metal in a tablet? However, is metal entered into tablets? What’s the toxicity level of metal? Etc. so we can remember of drawbacks before the method starts.

M (measure) Example:

In this section, we tend to attempt to measure the method. Like the theoretical weight of the tablet. Material testing. Processes to seek out metals in tablets like assays etc.

A (Analyse) Example:

In this section, we tend to attempt to perceive the basic reason behind the problem. Why metal enters the tablet? Why weight variation will occur etc.

I (Improvement) Example:

In this section, we tend to apply the selections that are taken when the analysis part, so no drawbacks are going to be there in the method.

C (control) Example:

In this method, we’ve to travel for the method capability index at the beginning of each method. For example, samplings of tablets should be tried at definite intervals.

Related Post: Good Documentation Practice (GDP) in Pharmaceuticals

Lean Methodology

Lean may be a systematic approach to reduce or eliminate activities that don’t add worth to the method that’s waste. Its five principles:

  • Exactly specify value by specific product
  • Establish the worth stream for every product,
  • Create value flow while not interruptions
  • Let the client pull value from the producer
  • Pursue perfection

The first demand in creating an undefeated transition to learning is to possess a transparent vision of what the corporate can become.

Lean methodology with the six sigma method

As the name indicates, ‘Lean Six Sigma is a merger of ‘Lean’ and “Six Sigma” processes. Thus, Lean Six Sigma (LSS) may be a combined method to form the business effective sanctions improvement in Quality and potency. Lean is all concerning speed and economic management of the business by reducing the waste of resources. In contrast, Six Sigma may be a methodology that minimizes errors in processes and quality improvement.

The link between lean and company environment:

Lean has two goals to scale back or get rid of waste and to form worth, whereas cGMP has a goal to make sure that controls are in place to deliver a secure and effective healthful product. Within the company, the atmosphere to enhance the operational potency of effective lean management ideas ought to be known as a result of many times cGMP, and lean management ideas overlap.

Pharma companies are concerned about product quality as compared to price and productivity. There’s a particular role of QC and quality assurance in implementing lean principles. Providing QC and quality assurance are strictly adopted, the management goals like the name of the corporate, sales, and profits can be achieved thanks to quality drugs with less price.

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