Quality Management Handouts - Module V

A Quality management system encompasses the planning, quality control, quality assurance, and
improvement of quality across various operations, aiming to enhance customer satisfaction and
improve compliance with regulatory requirements. An objective of a QMS is to manage a
company’s activities to comply with customer and regulatory requirements while continuously
improving effectiveness and efficiency through the systematic management of quality-related
activities.
This system defines how a company will achieve the creation and delivery of the products and
services they provide to their customers.

Quality Management System according to ISO 9001

ISO 9001 is a standard that defines the requirements for a Quality Management System
(QMS). It helps businesses and organizations be more efficient and improve customer
satisfaction. The primary focus of the ISO 9001 standard is to meet customer requirements and
strive to exceed customer expectations.

A Quality Management System based on ISO 9001:

 Defines how an organization can meet the requirements of its customers and other
stakeholders
 Promotes the idea of continual improvement
 Requires organizations to define objectives and continually improve their processes in
order to reach them
The ISO 9001 standard is based on a series of ISO 9000 standards:
 ISO 9001 – defines the requirements of a quality management system
 ISO 9000 – covers the basic concepts and language
 ISO 9004 – focuses on how to make a quality management system more efficient and
effective
 ISO 19011 – provides guidance on internal and external audits of quality management
systems
ISO 9001 specifies requirements for a quality management system when an organization wants
to:
 Demonstrate its ability to consistently provide products and services that meet customer
and applicable statutory and regulatory requirements
 Enhance customer satisfaction through the effective application of the system
 Implement processes for improvement of the system
 Integrate multiple management systems where the ISO 9001 structure is the same, such
as ISO 14001 (Environmental), ISO 45001 (Occupational Health and Safety), etc.
 Define its overall context and who is affected as well as what is expected
  Clearly state its objectives and identify new business opportunities
 Put customers first, making sure that their needs are consistently met and enhance their
satisfaction
 Have repeat customers, increase customer loyalty, add new clients and increase business
 Expand into new markets, as some sectors and clients require ISO 9001 before doing
business
 Identify and address the risks within the organization

Seven Quality Management Principles

The ISO 9001 Quality Management System is based on seven principles, each one a critical focus for
a system QMS. These seven principles are:

 Customer focus. If you are trying to provide products and services that meet customer
needs, you first need to be focused on what these needs are. This customer focus is the
foundation of improving customer satisfaction.
 Leadership :In order for the QMS to succeed, top management needs to provide
resources and adequate ongoing review of the system.

 Engagement of people. The people who work at your organization are the most
important asset, and their knowledge and experience need to be understood in the QMS.
 Process approach. A process is any activity that takes inputs, and creates outputs; these
inputs and outputs need not be simply physical; some are information or energy.
Everything we do in an organization is a process, and a system is created when we
understand that the inputs for one process come from a different process, and it is in these
interactions that we need to take particular care.
 Improvement :A company will only survive if it gets better over time, so the QMS needs
to focus on finding ways to do things better.

 Evidence-based decision making. Proper management cannot be done if we don’t know

how a process is actually working. By basing our decisions on facts, we can better
manage and improve the QMS.
 Relationship management. Sometimes the only way to improve our products and
services is to have our suppliers improve their products and services. In order to make
this work, we need to manage the relationship between ourselves and our suppliers.
ISO 9000 and ISO 14000 are tools to assist business and government to insure the quality
of their products and services, and to manage the impact of their activities on the
environment.
ISO 9000 is concerned with quality management and meeting customer quality
requirements, achieving control of processes, and encouraging continuous improvement
while ISO 14000 is concerned with environmental management.

ISO 14000
The ISO 14000 series The ISO 14000 series is a family of environmental management standards
developed by the International Organization for Standardisation (ISO). The ISO 14000 standards
are designed to provide an internationally recognised framework for environmental management,
measurement, evaluation and auditing.ISO 14000 standards are designed to provide an
internationally recognised framework for environmental management, measurement, evaluation
and auditing.
Six key elements of ISO 14000
 Environmental policy.
 Planning.
 Implementation.
 Study & correct.
 Management review.
 Continuous improvement.

Total Quality Management

Total quality management (TQM) is the continual process of detecting and reducing or
eliminating errors in manufacturing. It streamlines supply chain management, improves the
customer experience, and ensures that employees are up to speed with training. Total quality
management aims to hold all parties involved in the production process accountable for the
overall quality of the final product or service. Total quality management is a structured
approach to overall organizational management. The focus of the process is to improve the
quality of an organization's outputs, including goods and services, through the continual
improvement of internal practices. The standards set as part of the TQM approach can reflect
both internal priorities and any industry standards currently in place.
KEY TAKEAWAYS

 Total quality management (TQM) is an ongoing process of detecting and reducing or

eliminating errors.
  Total quality management is used to streamline supply chain management, improve
customer service, and ensure that employees are properly trained.
 The focus is to improve the quality of an organization's outputs, including goods and
services, through the continual improvement of internal practices.
 Total quality management aims to hold all parties involved in the production process
accountable for the overall quality of the final product or service.
 There are often eight guiding principles to TQM that range from focusing on customers,
continually improving, and adhering to processes.

Primary Principles of Total Quality Management

1.Customer focus

The first of the Total Quality Management principles puts the focus back on the people buying
your product or service. Your customers determine the quality of your product. If your product
fulfills a need and lasts as long or longer than expected, customers know that they have spent
their money on a quality product.

When you understand what your customer wants or needs, you have a better chance of figuring
out how to get the right materials, people, and processes in place to meet and exceed their
expectations.

2. Total employee commitment

You can’t increase productivity, processes, or sales without the total commitment of all
employees. They need to understand the vision and goals that have been communicated. They
must be sufficiently trained and given the proper resources to complete tasks in order to be
committed to reaching goals on time.
3. Process approach

Adhering to processes is critical in quality management. Processes ensure that the proper steps
are taken at the right time to ensure consistency and speed up production.

To implement this TQM principle:

 Use Total Quality Management tools such as process flowcharts to define and delineate
clear roles and responsibilities so everybody knows who does what at certain times.

 Create a visual action plan so everybody can easily see the specific activities that need to
be completed to achieve the desired result.

4. Integrated system

Typically a business has many different departments, each with their own specific functions and
purposes. These departments and functions should be interconnected with horizontal processes
that should be the focus of Total Quality Management. But sometimes these departments and
functions operate in isolated silos.

In an integrated system, everybody in every department should have a thorough understanding of

policies, standards, objectives, and processes. Integrated systems help the company to look for
continual improvement in order to achieve an edge over the competition.

5. Strategic and systematic approach

The International Organization for Standardization (ISO) describes this principle as:

“Identifying, understanding and managing interrelated processes as a system contributes to the

organization’s effectiveness and efficiency in achieving its objectives.”

Multiple processes within a development or production cycle are managed as a system of

processes in an effort to increase efficiency.

6.Continual improvement

Optimal efficiency and complete customer satisfaction doesn’t happen in a day—your business
should continually find ways to improve processes and adapt your products and services as
customer needs shift. As previously stated, the other Total Quality Management principles
should help your business keep an eye toward continual improvement.

7.Fact-based decision-making
Analysis and data gathering lead to better decisions based on the available information. Making
informed decisions leads to a better understanding of customers and your market.

To implement this TQM principle:

 Analyze and check data to ensure that it is reliable and accurate.

 Make relevant data available to stakeholders.

 Use valid methods to gather and analyze data.

 Make decisions based on the facts learned from the data in addition to your experience
and intuition.

8. Communications

Everybody in your organization needs to be aware of plans, strategies, and methods that will be
used to achieve goals. There is a greater risk of failure if you don’t have a good communication
plan.

Successful implementation of these Total Quality Management concepts will not come
overnight. Because TQM often represents a large cultural shift, you may want to implement
these changes in phases to lessen the impact.

SIX SIGMA

Six Sigma is a set of methodologies and tools used to improve business processes by reducing
defects and errors, minimizing variation, and increasing quality and efficiency. The goal of Six
Sigma is to achieve a level of quality that is nearly perfect, with only 3.4 defects per million
opportunities.

KEY TAKEWAYS

 Six Sigma is a quality-control methodology that businesses use to significantly reduce

defects and improve processes.
 The model was developed by a scientist at Motorola in the 1980s.
 Companies often use the Six Sigma model to increase efficiency and boost profits.
 Six Sigma practitioners can earn certifications modeled on the color belts used in martial
arts.
5 STEPS OF SIX SIGMA

Define

A team of people, led by a Six Sigma expert, chooses a process to focus on and defines the
problem it wishes to solve.

Measure

The team measures the initial performance of the process, creating a benchmark, and pinpoints a
list of inputs that may be hindering performance.

Analyze

Next the team analyzes the process by isolating each input, or potential reason for any failures,
and testing it as the possible root of the problem.

Improve

The team works from there to implement changes that will improve system performance.

Control

The group adds controls to the process to ensure it does not regress and become ineffective once
again.