Six sigma - A brief introduction

What is Six sigma?

➡️ Six Sigma is a set of tools and techniques to increase customer satisfaction and profitability by streamlining operations, improving quality and eliminating defects in every organization wide process.

➡️ It’s Greek symbol "sigma" or "σ," a statistical term for measuring process variable from the process mean or target. "Six Sigma" comes from the bell curve used in statistics. 

Who developed six sigma?

➡️ An American engineer Bill Smith working at Motorola company in 1986.

What are the benefits for using six sigma tools and techniques? 

• Increasing Customer Satisfaction
• Reducing Process Variability
• Improving Processes
• Lowering Defects
• Reducing Costs
• Increasing Profit

Sigma level vs percentage yield:

➡️ A six sigma process is a process that produces 3.4 defective parts per million opportunities (DPMO). 

➡️ Product percentage yield is directly proportional to sigma level. If sigma level is increase then percentage yield of product is increase and percentage of product defects reduce. See the following table for more details. 

Sigma level	DPMO	Percent defective	Percentage yield
1	691462	69%	31%
2	308538	31%	69%
3	66807	6.7%	93.3%
4	6210	0.62%	99.38%
5	233	0.023%	99.977%
6	3.4	0.00034%	99.99966%
7	0.019	0.0000019%	99.9999981%

➡️ If the process improvements do not reach 6 sigma, the improvements made from 3 sigma to 4 sigma to 5 sigma will still reduce costs and increase customer satisfaction.

The core Six Sigma principles:

➡️ Success of Six Sigma implementation is based upon following main principles:

• Always focus on the customer.
• Understand how work really happens.
• Make your processes flow smoothly.
• Reduce waste and concentrate on value.
• Stop defects through removing variation.
• Get buy-in from the team through collaboration.
• Make your efforts systematic and scientific.

The Six Sigma Methodology:

➡️ The two main Six Sigma methodologies are DMAIC and DMADV. Each has its own set of recommended procedures to be implemented for business transformation.
1. DMAIC is a data-driven method used to improve existing products or services for better customer satisfaction. 

➡️ It is the acronym for the five phases:

D – Define

M – Measure

A – Analyse

I – Improve

C – Control

➡️ DMAIC is applied in the manufacturing of a product or delivery of a service.

2. DMADV is a part of the Design for Six Sigma (DFSS) process used to design or re-design different processes of product manufacturing or service delivery.

➡️ The five phases of DMADV are: 

D – Define

M – Measure

A – Analyse

D – Design

V – Validate

➡️ DMADV is employed when existing processes do not meet customer conditions, even after optimization, or when it is required to develop new methods.

➡️ If you wish to know more about difference in details of DMAIC and DMADV, put your comment in comment section. So, I will be prepared and explained the same in next article. 

Six Sigma Techniques:

➡️ The Six Sigma methodology also uses a mix of statistical and data analysis tools and proven qualitative and quantitative techniques, to achieve the desired outcome.

Voice of the Customer:

➡️ It used in the "define" phase of the DMAIC cycle.

➡️ This is the process used to capture the "voice of the customer" or customer feedback by either internal or external means.

Root Cause Analysis/The 5 Whys:

➡️ It used in the "analyze" phase of the DMAIC cycle.

➡️ In the 5 Whys technique, the question "why" is asked, again and again, finally leading up to the core issue.

Brainstorming:

➡️ It used in the "improve" phase of the DMAIC cycle.

➡️ Brainstorming involves bouncing ideas and generating creative ways to approach a problem through intensive freewheeling group discussions.

The 5S System:

This technique is Japanese principle of workplace energies. The 5S System is aimed at removing waste and eliminating bottlenecks from inefficient tools, equipment, or resources in the workplace. 
➡️ The five steps used are Seiri (Sort), Seiton (Set In Order), Seiso (Shine), Seiketsu (Standardize), and Shitsuke (Sustain).

Kaizen (Continuous Improvement):

➡️ The Kaizen technique is a powerful strategy that powers a continuous engine for business improvement. It is the practice continuously monitoring, identifying, and executing improvements.  
➡️ Collective and ongoing improvements ensure a reduction in waste, as well as immediate change whenever the smallest inefficiency is observed.

Poka-yoke (Mistake Proofing):

➡️ This technique's name comes from the Japanese phrase meaning "to avoid errors," and entails preventing the chance of mistakes from occurring. 
➡️ In the poka-yoke technique, employees spot and remove inefficiencies and human errors during the manufacturing process.

Benchmarking:

➡️ It involves making comparisons with other businesses to gain an independent appraisal of the given situation.
➡️ Benchmarking may involve comparing important processes or departments within a business (internal benchmarking), comparing similar work areas or functions with industry leaders (functional benchmarking), or comparing similar products and services with that of competitors (competitive benchmarking).

Value Stream Mapping:

➡️ The objective is to remove waste and inefficiencies in the value stream and create leaner operations. 
➡️ It identifies seven different types of waste and three types of waste removal operations.

What are the tools of Six Sigma? 

➡️ Following are list of tools often used during product improvement. 

• Cause and Effect Analysis

• Flow Chart

• Pareto Chart

• Histogram

• Check Sheet

• Scatter Plot

• Control Chart

What are the Sigma levels? 

➡️ Based on knowledge, experience, training and eligibility, sigma level classified as white belt, yellow belt, green belt, black belta and master black belt. 

About the Author:

Dhansukh Viradiya is a highly accomplished expert in the pharmaceutical and biopharmaceutical industries. With over 10 years of experience in the field, he has gained comprehensive knowledge and expertise in various areas, including Process Validation, Cleaning Validation, Quality Management System, In-process quality assurance, Qualification etc.

Mr. Dhansukh holds a Master's degree in Pharmacy from a renowned University, where he specialized in Quality Assurance. 

As a thought leader, Mr. Dhansukh has published numerous articles and white papers on various topics related to pharmaceutical and biopharmaceutical industries. His research work focuses on emerging trends, current regulatory expectations, advancements in technology, personalized medicine, and the intersection of healthcare and technology.

With his passion for improving patient care and dedication to advancing the field, Dhansukh Viradiya continues to make significant contributions to the pharmaceutical and biopharmaceutical industries. His insights and expertise make him a valuable resource in understanding the dynamic landscape of these sectors and their impact on global healthcare.

Disclaimer:

The author's biography is provided for informational purposes only and does not imply any endorsement or affiliation with the article or its content.