TOOLS OF

TOTAL QUALITY MANAGEMENT

SYSTEM
Quality Management System

FOOD SAFETY

QUALITY TOTAL
MANAGEMENT QUALITY
HACCP ISO 9000 MANAGEMENT

GHP/GMP
 Leadership

Involvement
Focus

Quality Management
Principles
 Different Approaches in QMS

Quality Management
Principles

Mutual Benefit
 Total Quality Management (TQM) tools and techniques
have been formulated since last 60 years. These tools and
techniques are used to identify the potential problems,
frequency of their occurrences and method to control
these problems for adopting best class practices

The planning process is the glue that holds together all TQM activity

The final element of the TQM model is total participation

TQM organizations understand that all work is performed
through people. This begins with leadership. In TQM
organizations, top management takes personal responsibility
for implementing, nurturing, and refining all TQM activities.
They make sure people are properly trained, capable, and
actively participate in achieving organizational success.
Management and employees work together to create an
empowered environment where people are valued.

No two organizations have the same TQM implementation

Total Quality Management (TQM) is an integrated
system of principles, methods, and best practices
that provide a framework for organizations to
strive for excellence in everything they do

TQM is a collection of principles, techniques,

processes, and best practices that over time
have been proven effective.

The model begins with understanding customer needs. TQM

organizations have processes that continuously collect, analyze,
and act on customer information. Activities are often extended
to understanding competitor's customers. Developing an
intimate understanding of customer needs allows TQM
organizations to predict future customer behaviour
 TQM TOOLS AND TECHNIQUES
1) Six Sigma
It is a business strategy to achieve excellence by applying
different statistical, TQM and Project Management tools.
Six Sigma originated from the field of statistics as a set of
practices designed to improve manufacturing processes and
limited defects, but its application was subsequently extended to
other types of business processes as well.

In Six Sigma, a defect is defined as any process output that does not meet
customer specifications, or that could lead to creating an output that does not
meet customer specifications.
The term ‘Six Sigma’ referred to the ability of manufacturing processes to
produce a very high proportion of output within specification.

Defect levels below 3.4 defects per million opportunities (DPMO)

Bill Smith first formulated the particulars of the methodology at Motorola in 1986
Six Sigma projects follow two project methodologies inspired
by Deming's Plan-Do-Check-Act Cycle. These methodologies,
composed of five phases each, bear the acronyms DMAIC
(Define Measure Analyses Improve Control) and DMADV
(Define Measure Analyze Design and Verify)

DMAIC
It is used for projects aimed at improving an existing
business process
DMADV
It is used for projects aimed at creating new product or
process designs
2) Lean Manufacturing
It is a way of manufacturing that increases speed and reduces
unnecessary wastes.
Lean Manufacturing (also called Toyota Production System, TPS) is a
production system inspired by the Japanese concept of kaizen (the
strategy of continuous improvement).
Unlike kaizen, Lean has a focus not only on quality control but also on
quantity control to eliminate waste and reduce costs.
There are many definitions and viewpoints for ‘Lean Manufacturing’,
but the main goal of ‘Lean Manufacturing’ is to eliminate waste.
‘Waste’ refers especially to excess input materials and useless
processing steps.
The goal of ‘eliminating waste’ may also be stated as providing exactly
what the customer values for the lowest cost of production. This will
maximize profit per unit.
So another way of expressing the ‘Lean Manufacturing’ goal is to only
use materials and processes that add value for the customer.
3) Kaizen
Kaizen (Japanese for ‘improvement’ or ‘change for the better’) refers
to philosophy or practices that focus upon continuous improvement
of processes in manufacturing, engineering, supporting business
processes and management. It has been applied in healthcare,
psychotherapy, life-coaching, government, banking and many other
industries.

When used in the business sense and applied to the

workplace, kaizen refers to activities that continually
improve all functions and involves all employees
from the CEO to the assembly line workers. It also
applies to processes such as purchasing and logistics
that cross organizational boundaries into the supply
chain.
 The five main elements of kaizen
•Teamwork
•Personal discipline
•Improved morale
•Quality circles
•Suggestions for improvement

4) Lean Six Sigma

It is combination of Six Sigma and Lean
Manufacturing concept to reduce errors and
increase productivity side by side. ‘Lean’ and ‘Six
Sigma’ methodologies seem quite different but a
company can benefit by wisely uniting these
approaches.
 5) Total Productive Maintenance (TPM)
It is a new way of carrying maintenance activities and
invented by the Japanese.
TPM is a manufacturing-led initiative that creates a
collaborative approach among all stakeholders within an
organization — particularly between operations and
maintenance — in an effort to achieve production
efficiency, uninterrupted operations and ensure a quick,
proactive maintenance response to prevent equipment-
specific problems.
 The goal of TPM is to create a production
environment free from mechanical breakdowns
and technical disturbances by involving
everybody in maintenance duties without
heavily relying on mechanics or engineers.
Modernization and the ongoing automation in
different industries have noticeably amplified
the gap between operators and their machines.

TPM equips the operators the necessary skills to

address mechanical or equipment-related issues.
Calling the engineers and mechanics is no longer
necessary since operators are already prepared
and confident in dealing with the problems.
Undoubtedly, Total Productive Maintenance is
one of the most effective ways to create a lean
organization with reduced cycle time and
improved operational efficiency.
 Environmental Management System (ISO 14001

It is standard given by ISO to facilitate organization to reduce their

wastes that are harmful for the environment. ISO 14001 was first
published in 1996 and specifies the actual requirements for an
environmental management system. It applies to those environmental
aspects which the organization has control and over which it can be
expected to have an influence.

Laboratory Management System (ISO/ IEC 17025)

It is a standard for laboratories for their accreditation. ISO/ IEC
17025:2005 specifies the general requirements for the competence to
carry out tests and/ or calibrations, including sampling. It covers
testing and calibration performed using standard methods, non-
standard methods, and laboratory-developed methods. It is applicable
to all organizations performing tests and/ or calibrations. These
include, for example, first-, second- and third-party laboratories, and
laboratories where testing and/ or calibration forms part of inspection
and product certification
 5S Principle
5S
It is methodology for improvement in daily and business life in five steps. The
5S are pre-requisites for any improvement program. As waste is potential gain,
so eliminating waste is a gain. 5S philosophy focuses on effective work place
organization, implies work environment, reduction in waste while improving
quality and safety.

Principle Meaning
Seiri Sorting Out
Seiton Systematic Arrangement
Seison Spic and Span
Seiketsu Standardizing
Shitsuke Self-discipline
Plan-Do-Check-Act (PDCA) cycle.
•Design
Plan: Product design corresponds to the planning phase of management
•Production
Do: Production corresponds to doing-making, or working on the product that
was designed
•Sales
Check: Sales figures confirm whether the customer is satisfied
•Research
Action: In case of a complaint being filed, it has to be incorporated into the
Planning phase, and action taken for the next round of efforts

The four step cycle for problem solving includes

planning (definition of a problem and a hypothesis
about possible causes and solutions), doing
(implementing), checking (evaluating the results) and
action (back to plan if the results are unsatisfactory or
standardization if the results are satisfactory).
Quality circles
It is group of people, who identify problems and give their solution for
improvement in daily life and business. Quality circles were first seen in the
United States in the 1950’s and later developed by Dr. Kaoru Ishikawa in Japan
in the 1960’s.

Voluntary groups of employees who work on similar tasks or

share an area of responsibility can participate in quality circle.
They agree to meet on a regular basis to discuss and solve
problems related to work. They operate on the principle that
employee participation in decision-making and problem-solving
improves the quality of work. It enhances productivity, improve
quality and boost employee morale.
 CONCEPTS OF QUALITY MANAGEMENT SYSTEM (QMS) –
ISO 9000:2000

Continual Improvement of the

C Quality Management System
S C
a
U Management t U
S R Responsibility I
s
S
e
T q f T
a
u
O I
c O
t
M r Resource Measurement, analysis,
Improvement I M
e Management
E m
o
n
E
R e R
n
S t Product Product S
s Input
Output
ISO 9000:2000 standard defines process as
the "system of activities that uses resources
to transform inputs into outputs". This
definition has a strong point in two major
rules (1) inputs of one process are mainly
outputs of another and (2) processes are
managed in order to create new values
that correspond to requirements and
expectations of customers.

The ISO 9000 standards were first

published in 1987 and subsequently
revised in the year 1994 and 2000.
Standards are reviewed every five years to
ensure that they are current and satisfy
the needs of users
ISO 9000 is a starting point for understanding the standards, as it
defines the fundamental terms used in the ISO 9000 ‘family’, or set of
standards relating to quality management.
 ISO 9001 specifies requirements for a QMS to ensure that products
fulfill customer requirements as well as applicable regulatory
requirements; it also aims to enhance customer satisfaction.
ISO 9004 provides guidance on continual improvement of QMS so that
the needs and expectations of all interested parties are met. These
interested parties include customers and end-users directors and staff in
the organization; owners/ investors, suppliers and partners and society, at
large.
ISO 19011-Guidelines on quality and environmental management
systems auditing
ISO 9001 and ISO 9004 make a ‘consistent pair’ of standards that
relate modern quality management to the processes and activities of
an organization, and emphasize the promotion of continual
improvement and achievement of customer satisfaction.
ISO 9001, which focuses on the effectiveness of the QMS in
meeting customer requirements, is used for certification or for
contractual agreements between suppliers and buyers. On the other
hand, ISO 9004 cannot be used for certification as it does not
prescribe requirements but provides guidance for the continual
improvement of an organization’s performance.
 ISO 9001 focuses on ‘effectiveness’, i.e. doing the right things,
whereas ISO 9004 emphasizes both ‘effectiveness’ and ‘efficiency’,
i.e., doing the right thing in the right way.