QUALITY MANAGEMENT SYSTEM (QMS)

Introduction
A Quality Management System (QMS) is a formalized system that documents
processes, procedures, and responsibilities for achieving quality objectives. It helps organizations
ensure that they consistently meet customer requirements and enhance customer satisfaction. QMS
is used across industries to standardize quality-related activities, manage risks, and foster continuous
improvement.

Here’s a breakdown of its key components:

1. Processes and Procedures: A QMS includes a set of documented processes that cover all aspects
of an organization’s operations, from design and production to customer service. These procedures
guide employees in delivering quality consistently.
2.Quality Policy: This is a formal statement from management, outlining the organization’s
commitment to quality. It serves as a foundation for setting quality objectives.
3. Continuous Improvement: QMS promotes a culture of continuous improvement, often using tools
such as Plan-Do-Check-Act (PDCA) cycles, Lean, Six Sigma, or other methodologies.
4. Risk Management: Identifying potential risks to quality and implementing mitigation strategies is a
critical component. This helps in ensuring reliability and minimizing errors or defects.
5. Customer Focus: The system ensures that customer needs and expectations are central to every
process, driving customer satisfaction and loyalty.
6.Compliance and Standards: QMS often aligns with international standards like ISO 9001, which
defines specific requirements for creating an effective quality management system.
7.Documentation: QMS relies heavily on documentation for training, auditing, and continuous
improvement. Records and reports are kept to monitor quality performance and to ensure
compliance with regulatory requirements.

Benefits of QMS:
• Improved efficiency through process optimization.
• Higher customer satisfaction due to consistent product and service quality.
• Reduced costs by minimizing waste and errors.
• Compliance with legal and regulatory standards.s

HOW TO IMPLEMENT QUALITY MANAGEMENT SYSTEM

Implementing a Quality Management System (QMS) is a structured process that requires careful
planning, commitment from leadership, and a focus on continuous improvement. Here’s a step-by-
step guide to implementing a QMS:

1. Gain Leadership Commitment

1.Engage Top Management 2. Define Quality Policy
2. Understand and Align with Standards
1.Choose an Appropriate Standard 2. Understand the Requirements
3. Assess Current Processes
1.Conduct a Gap Analysis 2. Engage Key Stakeholders
4. Design and Document Processes
1.Develop Procedures: 2. Create a Quality Manual: 3. Control Documents:
5. Define Quality Objectives
 1.Set Measurable Goals: 2. Communicate Objectives:
6. Train and Engage Employees
1.Provide Training 2. Promote a Quality Culture
7. Implement Controls and Monitoring
1.Establish Key Performance Indicators (KPIs): 2.Management Review
8. Internal Audits and Reviews
1.Conduct Internal Audits 2. Continuous Improvement Programs
9. Continuous Improvement
1.Corrective and Preventive Action 2. Continuous Improvement Programs
10. Certification (if applicable)
1.Prepare for External Audits 2. Maintain Certification
11. Monitor and Improve
1.Customer Feedback 2.Review and Adapt

Key Tools for QMS Implementation

1. Risk Management Tools: FMEA (Failure Mode and Effects Analysis), risk registers.
2.Process Improvement Tools: PDCA, Lean, Six Sigma, root cause analysis.
3.Documentation Tools: Quality manuals, standard operating procedures (SOPs), forms, and
templates

seven quality management principles

Every successful business has a keen focus on quality. But if you want consistent quality, you need an
intelligent strategy. A QMS is a system of processes that enable your business to meet
your customer’s requirements and exceed their expectations. A QMS provides you with a roadmap to
superior product and service quality. Businesses that neglect to use a QMS often lack direction,
focus, and consistent product quality. The seven quality management principles we cover from the
ISO 9000 series. They are a set of international standards on quality management and are essential
elements for any quality program.

#1 — Customer Focus

The biggest and best companies on earth all focus on customer satisfaction. They don’t just build
products and sell them. They speak to their customers and engage them in co-creation. They listen to
their feedback and then act on it. There is only one boss. The customer. And he can fire everybody in
the company from the chairman on down, simply by spending his money somewhere else.

The challenge of this principle is to satisfy the customer, to build loyalty.

This is even more important as nowadays, with social networks and the internet in general, the
customer can express his dissatisfaction / his delight and be heard by all, immediately. This can either
destroy an organisation’s image or, on the contrary, give it an excellent reputation.

#2 — Leadership

Great leaders will help your team work towards the same quality goals, improving the overall level of
quality in your organization. If you’ve worked with bad leaders, you know the damage they can
cause. Leadership is the art of getting someone else to do something you want done because he
wants to do it.

#3 — People Engagement
Having engaged and motivated employees and supply chain partners is key to execute on your
quality objectives and create value. The added value of the work of the staff and the initiatives taken
must me recognized. Personal skills must be developed, which will improve the skills of the
organisation as a whole. To start with, you need to set achievable goals. You then need to reward
your staff when they reach or exceed them and be open to their suggestions.

#4 — Process Approach

But first, you need to understand how your business creates results, and how each process fits into a
larger system. To do this, you must measure the effectiveness of each process, including its time,
cost, and results. Then, you need to analyse your processes and use the results to better deploy your
resources. Digital platforms can help with this process by measuring and analysing the efficiency of
your processes. You can then optimize your processes and create better quality products.

#5 — Continuous Improvement

Successful businesses are consistently innovating and improving. Life is like riding a bicycle. To keep
your balance, you must keep moving. You have to find a balance between learning from your
mistakes and recognizing your achievements.

Rewarding staff and suppliers for their hard work and offering them ways to learn and improve
themselves is vital to continuous improvement. However, tracking the performance of your
processes and employees can be a tiresome process. You might benefit from using a digital platform
to stay on top of your company’s continuous improvement.

#6 — Evidence-Based Decision Making

You need to gather and analyse useful data. You then need to use data-driven insights to make better
informed decisions.

#7 — Relationship Management

Maintaining a strong supply chain requires nurturing your relationships with your suppliers. Over
time, this will generate a strong spirit of collaboration from one end of your supply chain to the
other. Every business, including yours, sits in a chain of relationships between suppliers and
customers. Rewarding your suppliers for areas in which they succeed will foster even stronger
relationships

Quality Planning
Quality Planning is a critical process within quality management that involves identifying the
standards of quality relevant to a project or product and determining how to meet those standards.
The goal of quality planning is to ensure that a product or service meets customer expectations and
complies with regulatory requirements by designing processes and practices that support consistent
quality outcomes.

Steps in Quality Planning:

1. Determine Customer Needs: Understand what the customer expects from the product or
service. This includes functionality, durability, aesthetics, and performance.
2. Identify Quality Standards: Research applicable industry, regulatory, and legal standards that
need to be met.
3. Develop the Quality Plan:
 o Document the quality objectives, metrics, and processes that will be used
throughout the project or production cycle.
o Define roles and responsibilities for quality-related tasks.
4. Implement the Plan: Ensure that the processes and systems designed to achieve quality are
in place. This includes employee training and ensuring proper communication of quality
standards.
5. Monitor and Adjust: Continuously monitor performance against the quality metrics and
make necessary adjustments to processes to address any issues that arise.

Importance of Quality Planning:

• Ensures that customer expectations are met, leading to higher satisfaction.

• Reduces the likelihood of defects or non-compliance with regulations.
• Lowers costs associated with rework, waste, or recalls.
• Enhances organizational reputation for quality and reliability.
• Contributes to long-term sustainability through continuous improvement.
 PHILOSOPHIES OF VARIOUS QUALITY GURUS:

1)W. Edwards Deming:

➢ the father of modern quality management and he was inspired by Dr. Shewhart'
➢ His quality-control methods helped post-World War II Japan rebuild its
devastated economy.
➢ Focused on System Improvement, Total Quality Management (TQM).
➢ He developed the "Deming Cycle also known as Plan-Do-Check-Act cycle (PDCA)
➢ his emphasis on the importance of statistical process control and continuous improvement
➢ The Deming System of Profound Knowledge®
➢ offered Seven Deadly Diseases"
• Lack of constancy of purpose
• Emphasis on short-term profits:
• Evaluation of performance, merit rating, or annual review.
• Mobility of management; job hopping
• Management by use only of visible figures,
• Excessive medical costs
• Excessive costs of liability, swelled by lawyers that work on contingency fees.
➢ offered 14 key principles for management are
• Create a constant purpose toward improvement.
• Adopt the new philosophy
• Stop depending on inspections
• Use a single supplier for any one item.
• Improve constantly and forever
• Use training on the job
• Implement leadership
• Eliminate fear
• Break down barriers between departments
• Get rid of unclear slogans.
• Eliminate management by objectives.
• Remove barriers to pride of workmanship.
• Implement education and self-improvement
• Make "transformation" everyone's job.

2)Joseph M. Juran:
➢ Father of quality control
➢ Born in 1904, Joseph Juran was a Romanian-born, American engineer and management
consultant
➢ He defined Quality as Fitness for Use
➢ Introduced the concept of the Pareto Principle, the 80/20 rule
The Pareto principle states that for many outcomes, roughly 80% of consequences come
from 20% of causes. In other words, a small percentage of causes have an outsized effect.
This concept is important to understand because it can help you identify which initiatives
to prioritize so you can make the most impact. Here are a few examples of how to use the
tool in practice.
 1.Productivity-- You can use the 80/20 rule to prioritize the tasks that you need to get
done during the day.
2. Decision making-- The Pareto principle can help you to make the best decisions during
the problem-solving process. When there are many different causes to one problem, the
Pareto principle can help you prioritize solutions
3. Quality control-- In the Six Sigma methodology, using a Pareto chart can help you
visualize your data to identify how to prioritize actions.
Examples: 20% of bugs contribute 80% of crashes, 20% of customers contribute 80% of
revenue, 20% of workers contribute in 80% result.

➢ Contributed to Cost of Quality

Cost of Quality is a methodology used to define and measure where and what amount of
an organization’s resources are being used for prevention activities and maintaining
product quality as opposed to the costs resulting from internal and external failures. The
Cost of Quality can be represented by the sum of two factors.
CoQ = CoGQ + CoPQ

The Cost of Good Quality (CoGQ)

1. Prevention Costs – costs incurred from activities intended to keep failures to a minimum.
These can include, Establishing Product Specifications, Quality Planning, New Product
Development and Testing, Development of a Quality Management System (QMS), Proper
Employee Training
2. Appraisal Costs – costs incurred to maintain acceptable product quality levels. Appraisal
costs can include, Incoming Material Inspections, Process Controls, Check Fixture, Quality
Audits, Supplier Assessments

The Cost of Poor Quality (CoPQ)

3. Internal Failures – costs associated with defects found before the product or service
reaches the customer. Internal Failures may include, Excessive Scrap, Product Re-work,
Waste due to poorly designed processes, Machine breakdown due to improper
maintenance, Costs associated with failure analysis
4. External Failures – costs associated with defects found after the customer receives the
product or service. External Failures may include, Service and Repair Cost, Warranty Claims,
Customer Complaints, Product or Material Returns, Incorrect Sales Orders, Shipping Damage
due to Inadequate Packaging.
• The Cost of Good Quality is the sum of Prevention Cost and Appraisal Cost (CoGQ = PC + AC)
• The Cost of Poor Quality is the sum of Internal and External Failure Costs (CoPQ = IFC + EFC)

➢ Juran's Trilogy: 1980s. This was a new way of thinking about quality, and also a way of
managing quality. And is now the basis for much quality management work.
 ❖ Quality Planning Steps:
1)Quality planning is the structured process of designing products and services to
meet new goals and ensure that customer needs are met.
2)steps-- Establish the project, identify customers, Discover the customer’s needs,
Develop the product, Develop the process, Develop the controls and transfer to Operations.
❖ Quality Control:
1) "a process for meeting the established goals by evaluating and comparing
actual performance and planned performance and taking action on the
difference."
2) steps--Choose a control subject, Establish Measurement, Establish Standards of
Performance, Measure Actual Performance, Compare to Standards (interpret the difference).
Act on the difference.
❖ Quality Improvement:
1) Quality improvement is the process of creating breakthrough levels of
performance by eliminating wastes and defects to reduce the cost of poor quality.
2) steps--Prove the need for improvement, Identify the improvement projects,
establish project improvement teams, Provide project teams with resources.
➢ Quality Improvement – 10 Steps
• Establish awareness for the need to improve and the opportunities for
improvement.
• Set goals for improvement.
• Organise to meet the goals that have been set.
• Provide training.
• Implement projects aimed at solving problems.
• Report progress.
• Give recognition.
• Communicate results.
• Keep score.
• Maintain momentum by building improvement into the company's regular
systems.

3) Walter Shewhart:

➢ Known as the 'father of statistical process control’,

➢ Walter A Shewhart was born in USA in 1891
➢ He invented the Control Chart or Shewhart chart’ or statistical process control chart (SPCC)
The control chart is a graph used to study how a process changes over time. Data are plotted
in time order. It is used for distinguishes between common and special causes of variation to
determine the most appropriate improvement approach
➢ The PDCA model was first developed in the mid-20th Century by Mr. Walter A. Shewhart
➢ He invented the Statistical Process Control (SPC) technique in 1924
It is a quality control method that uses statistical analysis to monitor and control the quality
of a production process. It helps to ensure that a process is operating efficiently and
producing products that meet specifications. SPC can help to reduce waste, improve product
quality, and increase customer satisfaction.
 4.Armand V. Feigenbaum
➢ Introduced the concept of Total Quality Control (TQC)
It is a system of integrated controls that ensures customer quality satisfaction and
economical costs of quality. It includes engineering, purchasing, financial
administration, marketing, and manufacturing. TQC involves all employees in an
organization in the continuous improvement of processes, products and services. This
is achieved through a combination of process control, statistical analysis, process
mapping, root cause analysis, and employee involvement and empowerment.
➢ He emphasized the importance of customer focus and the need for continuous
improvement
➢ Introduced the concept of the "Cost of Quality, "which measures the cost of preventing
defects and the cost of fixing defects

5.shigeo Shingo
➢ He was a Japanese industrial engineer and business consultant.
➢ He developed the Single Minute Exchange of Die (SMED) concept.
SMED, or Single-Minute Exchange of Die, is a Lean tool used in manufacturing to reduce
equipment changeover time. The goal of SMED is to complete as many steps as possible
while the equipment is running (or processing), to save time and quickly change over to
processing the next product.
➢ introducing the concept of "poka-yoke,“
Poka-yoke is a Japanese term that means “mistake-proofing.” It is a Lean tool
Implementing poka-yoke involves designing a process in such a way that mistakes are
avoided entirely or made visible for quick correction.
➢ Shingo is known for his contributions to lean manufacturing.
Lean manufacturing is a production practice that aims to eliminate waste and increase value
for customers

6. Kaoru Ishikawa
➢ Kaoru Ishikawa was born in Japan 1915
➢ Known as father of Japanese quality control effort
➢ He invented the concept of ‘quality circles’ in 1960
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.
➢ He also created the concept of Company Wide Quality Control
Is a management philosophy that focuses on improving the quality of a company's products
and services. It's also known as total quality. This requires the involvement of all, from the
top management to bottom of an organization and from the start to the finish of the product
life cycle. CWQC includes activities like market research, design, manufacturing, aftersales
service, and evaluating data from user experience. CWQC aims to: Improve customer
satisfaction, contribute to profit, reduced defect& cost, Company reputation is increased,
ensure that products and services meet standards, build consumer trust, Sales and market
opportunities are increased
 ➢ Presented concept of the ‘fishbone diagram’ This is also known as the cause-and-effect
diagram or Ishikawa diagram
A fishbone diagram, also known as an Ishikawa diagram or cause-and-effect diagram, is a
visual tool used for problem-solving and root cause analysis. It’s structured like a fish
skeleton, with the problem at the “head” and potential causes branching off as “bones.”.
Organizing causes in this way helps teams systematically identify and understand the root
causes of a problem. The method is used in various industries, from manufacturing to
healthcare, to facilitate collaborative problem-solving and decision-making processes
➢ The phrase “the next process is your customer,”
He first used the phrase when he was working for a company where, instead of working
together, the departments within the company viewed each other as enemies. means
that the internal person or group receiving your work output should be considered your
customer

7) Genichi Taguchi :

➢ Taguchi was a Japanese engineer and quality control expert known for his contributions to
the statistics and quality control field.
➢ He developed the concept of "loss function," which measures the deviation of a product
from its target specification.
➢ He also introduced the idea of using "robust design" to create products insensitive to
variations in manufacturing processes.
➢ Taguchi's methods are widely used worldwide to improve the quality of products and reduce
manufacturing costs

8) Philip B. Crosby:

➢ introduced the concept of "Zero Defects and quality is free concept

Crosby's zero defects is a concept that states that quality is conformance to
requirements and that any deviation from the specifications is unacceptable. It
advocates for preventing defects rather than detecting and correcting them. It also
promotes a culture of quality awareness, commitment, and accountability. Crosby's
zero defects is a motivational tool that challenges organizations to achieve high
standards of quality.
• Maintaining quality by satisfying requirements
• Let's do it right the first time.
• Quality is measured in terms of money
➢ introduced the concept of the "Cost of Nonconformance,
➢ 14 Steps to Quality Improvement
• Management commitment
• Quality improvement team
• Quality measurement
• Cost of quality
• Quality awareness
• Corrective action
• zero defects planning
• Supervisor training
• Schedule regular