Quality Pioneers and their key Contributions

Definitions of Quality:

1. The degree to which a set of inherent properties of a product, system or process fulfils requirements. (ICH Q9)  

2. The degree to which a set of inherent characteristics fulfill requirements - ISO 9000 

3. A degree of excellence – The Concise Oxford Dictionary 

4. Fitness for use – Joseph Juran 

5. Quality is a dynamic state associated with products, services, people, processes, and environments that meets or exceeds expectations and helps produce superior value – Goetsch and Davis (2010) 

6. Conformance to requirements – Phil B. Crosby (1979) 

Top most popular Quality Gurus:

1. Joseph Juran (December 24, 1904 – February 28, 2008):

Joseph Moses Juran known as the "father" of modern-day Quality management. He was a Romanian-born American engineer.

His contribution to society:

Joseph Juran was a management consultant specialising in managing quality. He has authored nos. of papers and 12 books, including famous book of Juran's Quality control handbook, Quality Planning and Analysis, and Juran on Leadership for Quality.

Pareto principle:

Vilfredo Pareto was an Italian economist who observed that 80% of the effects come from 20% of the causes. Juran applied his observations to business management and economics.

Juran's Trilogy:

It is an approach to cross-functional management composed of following three managerial processes:

1. Quality Planning

Quality Planning is the activity of developing the products and processes required to meet customers' needs.

2. Quality Control

Quality Control is the activity of monitoring production activities to ensure that they are producing the correct product or service according to plan.

3. Quality Improvement

Quality Improvement is the activity of making changes to improve the process and raising quality performance to extraordinary levels.

Cost of quality

The cost of quality (or the cost of not getting it right the first time) should be recorded and analysed.

Quality Improvement 

Ten steps to quality improvement are…

1. Build awareness of the need and opportunity to improve

2. Set goals for that improvement

3. Create plans to reach the goals

4. Provide training

5. Conduct projects to solve problems

6. Report on progress

7. Give recognition for success

8. Communicate results

9. Keep score

10. Maintain momentum

2. William Edwards Deming (October 14, 1900 – December 20, 1993):

Edwards Deming was an American engineer, statistician, professor, author, lecturer, and management consultant. Educated initially as an electrical engineer and later specializing in mathematical physics, he helped develop the sampling techniques still used by the U.S. Department of the Census and the Bureau of Labour Statistics.

His contribution to society:

The Deming Cycle - PDCA

PDCA (Plan-Do-Check-Act) is an iterative four-step management method used in business to control and continuously improve processes and products.

1. Plan

Plan the action. Assess the current and future state, and plan how to close the gap. Identify alternate solutions.

2. Do

Try out or test the solutions (sometimes at a pilot level).

3. Check

Check to see if the tested solutions accomplished the objective.

4. Act

Analyse the difference between actual and planned results. If the gap is significant, determine the root cause and request corrective action.

Deming's fourteen points for Total Quality Management include:

1. Create constancy of purpose

Create constancy of purpose toward improvement of product and service, with the aim to become competitive, stay in business, and provide jobs.

2. Adopt the new philosophy

Adopt the new philosophy. We are in a new economic age. Western management must awaken to the challenge, learn their responsibilities, and take on leadership for change.

3. Cease dependence on inspection

Cease dependence on inspection to achieve quality. Eliminate the need for inspection on a mass basis by building quality into the product in the first place.

4. End the practice of awarding business on the basis of price tag

End the practice of awarding business on the basis of the price tag. Instead, minimize total cost. Move toward a single supplier for any one item, on a long-term relationship of loyalty and trust.

5. Improve constantly

Improve constantly and forever the system of production and service to improve quality and productivity, thus constantly decreasing costs.

6. Institute training

Institute training on the job.

7. Institute leadership

The aim of supervision should be to help people and machines and gadgets to do a better job. Supervision of management needs an overhaul, as well as supervision of production workers.

8. Drive out fear

Drive out fear so that everyone may work effectively for the company.

9. Break down barriers

Break down barriers between departments. People in research, design, sales, and production must work as a team to foresee problems of production and in use that may be encountered with the product or service.

10. Eliminate slogans, exhortations, and targets

Eliminate work standards (quotas) on the factory floor.

Eliminate management by objective. Eliminate management by numbers and numerical goals. 

11. Pride of workmanship

Remove barriers that rob the hourly worker of his right to pride in workmanship. The responsibility of supervisors must be changed from sheer numbers to quality.

12. Abolishment of the annual or merit rating

Remove barriers that rob people in management and engineering of their right to pride in workmanship. This means, among other things, abolishing the annual or merit rating and Management by Objectives.

13. Education and self-improvement

Institute a vigorous program of education and self-improvement.

14. Transformation

Put everybody in the company to work to accomplish the transformation. Transformation is everybody's job.

3. Kaoru Ishikawa (July 13, 1915 – April 16, 1989):

Kaoru Ishikawa was a Japanese organizational theorist and a professor in the engineering faculty at the University of Tokyo noted for his quality management innovations. 

He is considered a key figure in the development of quality initiatives in Japan, particularly the quality circle. 

He is best known outside Japan for the Ishikawa or cause and effect diagram (also known as the fishbone diagram), often used in the analysis of industrial processes.

He wrote 647 articles and 31 books, including two translated into English: "Introduction to Quality Control" and "What Is Total Quality Control?

His contribution to society:

Ishikawa Diagram:

The Ishikawa Diagram is also called the Fishbone diagram and the Cause-and-Effect-Analysis. This is the most commonly used to analyse a problem and to find out the potential causes creating the problem.

Quality Circles

Quality Circle is a small group of employees working in the same area or doing the same job. This group regularly meets for one hour every week to identify and collectively resolve the problems in the work area. They use Seven Basic Quality tools to understand the causes and propose solutions.

Seven Basic Quality Tools:

1. Flow charts (Also called as Stratification or Run Chart)

2. Scatter diagrams

3. Pareto Charts

4. Histogram

5. Check sheets

6. Cause and Effect Diagram

7. Control charts

Company-wide Quality Control

He emphasized the concept of internal customers and Company-wide Quality. This requires the involvement of all, from the top management to the front-line workers. He suggested the following benefits of the Company-wide Quality approach.

  • Reduced defects
  • Improved product quality
  • The quality improvement becomes the norm rather than the exception
  • Increased reliability
  • Reduced costs
  • Wastes are identified and reduced
  • Rework is identified and reduced
  • Improvement techniques are established, and the product and processes are continually improved
  • Inspection and after-the-fact expenses are reduced
  • Sales and market opportunities are increased
  • Company reputation is increased
  • Interdepartmental barriers are broken down, and communication becomes easier
  • False and inaccurate data is reduced
  • Improvement in human relations
  • Company loyalty is increased

4. Walter Shewhart (March 18, 1891- March 11, 1967):

Walter Andrew Shewhart was an American physicist engineer and statistician, sometimes known as the father of statistical quality control.

He also lectured on quality control and applied statistics at the University of London, Stevens Institute of Technology, the graduate school of the U.S. Department of Agriculture, and in India.

His contribution to society:

Control Charts

Control charts are also known as Shewhart charts (after Walter A. Shewhart ).

Shewhart classified the causes of variation as "assignable cause" and "chance cause".

PDCA Cycle

The original founder of the PDCA cycle (Plan-Do-Check-Act) is Walter A. Shewhart.  Edwards Deming promoted the use of the PDCA cycle for process improvement and later changed it to the PDSA cycle (Plan-Do-Study-Act).

5. Philip Crosby (Jun 18, 1926- Aug 18, 2006):

Crosby is founder and chairman of the board of Career IV, an executive management consulting firm. Crosby also founded Philip Crosby Associates Inc. and the Quality College. He has authored many books, including Quality is free, Quality without tears, Let's talk Quality, and Leading: The art of becoming an executive. Crosby originated the concept of zero defects.

His contribution to society:

Crosby give principle "doing it right the first time"

The Crosby Vaccine

In the Crosby style, the "Vaccine" is explained as medicine for management to prevent poor quality. It is in five sections that cover the requirements of Total Quality Management.

Integrity

Treat quality seriously throughout the whole business organization from top to bottom. The company's future will be judged on its performance on quality.

Systems

Appropriate measures and systems should be put in place for quality costs, education, quality, performance, review, improvement and customer satisfaction.

Communication

The communication systems are of paramount importance to communicate requirements and specifications and improvement opportunities around the organization. Customers and operators know what needs to be put in place to improve, and listening to them will give you the edge.

Operations

Work with and develop suppliers. Processes should be capable, and improvement culture should be the norm.

Policies

Policies must be clear and consistent throughout the business.

The Fourteen Steps to Quality Improvement

1. Management Commitment

Make it clear that management is committed to quality.

2. Quality Improvement Teams

Form Quality Improvement Teams with senior representatives from each department.

3. Measure Processes

Measure processes to determine where current and potential quality problems lie.

4. Cost of Quality

Evaluate the cost of quality and explain its use as a management tool.

5. Quality Awareness

Raise the quality awareness and personal concern of all employees.

6. Correct Problems

Take actions to correct problems identified through previous steps.

7. Monitor Progress

Establish progress monitoring for the improvement process.

8. Train Supervisors

Train supervisors to actively carry out their part of the quality improvement program.

9. Zero Defects Day

Hold a Zero Defects Day to reaffirm management commitment.

10. Establish Improvement Goals

Encourage individuals to establish improvement goals for themselves and their group.

11. Remove Fear

Encourage employees to tell management about obstacles to improving quality.

12. Recognize

Recognize and appreciate those who participate.

13. Quality Councils

Establish Quality Councils to communicate on a regular basis.

14. Repeat the Cycle

Do it all over again to emphasize that the quality improvement process never ends.

Apart of above quality gurus, following Quality gurus are also  contributed in society to many quality tools for improvement of product quality.

1. Shigeo Shingo (1909-1990):

He is best known for “Poka-yoke” is a Japanese term that means “mistake-proofing”.

2. Taiichi Ohno (1912-1990):

He is best known for “Toyota Production System” and “Seven types of wastes (Muda)”.

3. Genichi Taguchi (Jan 1, 1924-June 2, 2012):

Genichi Taguchi is best known for:

Taguchi Methods

Taguchi Loss Function

Design of Experiments

Robust Design

Quality Engineering

4. Armand Feigenbaum (1922-2014):

Feigenbaum is best known for:

Total Quality Control

Hidden Plant

Quality Costs


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.

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