Module 6

Quality Systems

Quality Systems
A quality system is defined as the collective plans,

activities and events that are provided to ensure that

a product, process or service will satisfy given needs.
The

design

and

implementation

of

quality

management system will vary depending on the type,

size and products of the organisation. Each company
will have it's own objective, however most companies
objective is to increase profitability.

A Quality System will assist by:

managing costs and risks
increasing effectiveness and productivity
identifying improvement opportunities
increasing customer satisfaction

Excellence Models
Quality Awards and Standards
Malcolm Baldrige National Quality Award
(MBNQA)
The Deming Prize
ISO 9000 Certification
ISO 14000 Standards

MBNQA- What Is It?

Malcolm Baldrige National Quality Award
Award named after the former Secretary of
Commerce Regan Administration
Intended to reward and stimulate quality
initiatives
Original
categories
were
manufacturing,
service, and small business. Healthcare,
education, and non-profit categories have been
added.
Past winners: Motorola Corp., Xerox, FedEx, 3M,
IBM, Ritz-Carlton

Bald ridge Criteria

Applicants are evaluated on:
Categories
Points
Leadership
120
Strategic Planning
85
Customer & Market Focus
85
Measurement, Analysis, and Knowledge
Management
90
Workforce Focus
85
Process Management
85
Results
450

The Deming Prize

Given by the Union of Japanese Scientists
and Engineers since 1951
Named after W. Edwards Deming who
worked to improve Japanese quality after
WWII
Not open to foreign companies until 1984
Florida P & L was first US company winner

 The Deming prize, established in December 1950

in honor of W. Edwards Deming, was originally
designed to reward Japanese companies for major
advances in quality improvement.
Over the years it has grown, under the guidance of
Japanese Union of Scientists and Engineers (JUSE) to
where it is now also available to non-Japanese
companies, albeit usually operating in Japan, and
also to individuals recognized as having made major
contributions to the advancement of quality. The
awards ceremony is broadcast every year in Japan
on national television.
Two categories of awards are made annually, the
Deming Prize for Individuals and the Deming
Application Prize.

ISO 9000
Series of standards agreed upon by the
International
Organization
for
Standardization (ISO)
Adopted in 1987
More than 100 countries including India
A prerequisite for global competition
ISO 9000 directs you to "document what you
do and then do as you documented."
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 ISO is an international organization engaged in

developing standards for various management
systems. The abbreviation ISO stands for
International Organization for Standardization.
ISO Certification can be for many international
standards or management systems like for a
Quality Management System (QMS)- ISO
9001:2008, Environment Management System
(EMS)- ISO 14001:2004 , Occupational Health
and Safety Management System or OHSMS,
Food Safety Management System (FSMS)- ISO
22000:2005, Information Security Management
System (ISMS)- ISO 27001:2005 so on and so
forth.

ISO 9000:2000 Consists of 3

Areas
ISO 9000:2000 Quality Management
Systems: fundamentals and vocabulary
ISO 9001:2000 Quality Management Systems
Requirements (required for certification)
Management responsibility
Resource management
Product/service realization
Measurement, analysis, improvement

ISO 9004-2000 Quality Management Systems

Guidelines for performance improvement

ISO 9000

ISO 9000 Family of

Standards

ISO 8402 - QA and Quality management vocabulary

ISO 9000-2 - Generic guidelines for applying ISO
9001, ISO 9002, and ISO 9003
ISO 9000-3 - Guidelines for applying ISO 9001 to the
development, supply, and maintenance of
software
ISO 9000-4 Application for dependability
management
ISO 9004-2 Guidelines for services
ISO 9004-3 Guidelines for processed material
ISO 9004-4 Guidelines for quality improvement
ISO 9004-5 Guidelines for quality plans
ISO 9004-6 Guidelines for configuration management
ISO 9000

Scope of ISO 9001 : 2000

This
international
standard
specifies
requirements of a quality system where an
organization
Needs to demonstrate its ability to consistently
provide products that meet customer and applicable
regulatory requirements.
Aims to enhance customer satisfaction through the
effective application of the system including
processes for continued improvement of the system
and the assurance of conformity to customer and
applicable regulatory requirements.

Why adopt ISO 9000?

To comply with customers who require
ISO 9000
To sell in the foreign markets
To compete in domestic markets
To improve the quality system
To minimize repetitive auditing by similar
and different customers
To improve subcontractors performance
ISO 9000

ISO 14000
The ISO 14000 family addresses various
aspects of environmental management. It
provides practical tools for companies and
organizations looking to identify and control
their environmental impact and constantly
improve their environmental performance.
ISO 14001:2004 and ISO 14004:2004 focus
on environmental management systems.
The other standards in the family focus on
specific environmental aspects such as life
cycle analysis, communication and auditing.

QS 9000
QS 9000 is the name given to the Quality
System Requirements of the automotive
industry which were developed by Chrysler,
Ford, General Motors and major truck
manufacturers and issued in late 1994.
QS-9000
replaces
such
quality
system
requirements as Ford Q-101, Chrysler's
Supplier Quality Assurance Manual, GM's NAO
Targets
for
Excellence
and
the
Truck
Manufacturer's quality system manuals.

 The influence of QS-9000 is being seen

throughout the automotive industry as it has
virtually eliminated varying demands and waste
associated with redundant systems.
Proof
of
conformance
to
QS-9000
is
certification/registration by an accredited third
party such as Underwriter's Laboratories (UL) or
the American Bureau of Shipping (ABS).
Companies that become registered under QS9000 will be considered to have higher
standards and better quality products.

THE NEW APPROACH TO OH&S

MANAGEMENT SYSTEM
Organizations are responsible for risk that arises out
of their own workplaces.
* Management need to be committed to OH&S:- The old assumption that workers are
responsible for causing accidents are not
entirely valid.
* Self-regulated
* Proactive management approach

OHAS (OHSAS)
OHAS 18001 is a British Standard that sets
out the requirements for Health & Safety
Management
Systems
in
order
for
organisations
to
implement
compliant
occupational health and safety performance.
It was developed in response to widespread
demand for a recognized standard against
which to be certified and assessed.

Characteristics of OHAS
Voluntary management system
Integrates OH&S hazards into business
process
Identify, assess and control hazards relating
to business
Anticipates and meets OH&S performance
expectations (national / international level)
Applicable to any organization, regardless of
size, type, or level of maturity

Importance of OHSAS
A specific reduction in the number of accidents, incidents
and cases of work-related illness
A reduction in the level of sickness absence
A specific increase in the number of minor accidents and
near miss incidents
A reduction in the number of civil claims
No enforcement notices from the relevant Enforcement
Agency
A specific improvement in health and safety audit scores
Achievement of a nationally recognised health and safety
management system (e.g. OHSAS 18001).

PURPOSE OF OHAS
Identify regulatory requirements compliance to
local and national laws.
Identify hazards and risks pertinent to current
work activities.
Manage risks introduce controls to manage
risks to as low as reasonably practicable
(ALARP).

PURPOSE OF OHAS
Establish a policy and objectives introduce
plans to manage the risks that has been identified.
Implement the plans.
Monitor performance obtain feedback and
make the necessary changes to the policy or
objectives if required.

FMEA (Failure Modes Effect

Analysis)
A structured approach to:
Identifying the ways in which a product or process can
fail
Estimating risk associated with specific causes
Prioritizing the actions that should be taken to reduce
risk
Evaluating design validation plan (design FMEA) or
current control plan (process FMEA)

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When to Conduct an FMEA

Early in the process improvement investigation
When new systems, products, and processes are
being designed
When existing designs or processes are being
changed
When carry-over
applications

designs

are

used

in

new

After system, product, or process functions are

defined, but before specific hardware is selected or
released to manufacturing

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Design for Manufacturing

(DFM)
Design for manufacturing (DFM) is design
based on minimizing the cost of production
and/or time to market for a product, while
maintaining an appropriate level of quality.
The strategy in DFM involves minimizing the
number of parts in a product and selecting
the appropriate manufacturing process.

Benefits of DFM
It reduces part count thereby reducing
cost.
It

increases

reliability,

because

if

the

production process is simplified, then there

is less opportunity for errors.
It generally increases the quality of the
product