Systems & performance

improvement methodologies
ISO 9000
ISO 9000
• ISO 9000 is a set of international standards for quality.
• Organizations are audited and certified against the requirements of the standard.
• The standard includes elements that are considered important in a quality management system, from senior
management responsibility to documentation to continuous improvement.
• Customers of a certified organization can be assured that their supplier has minimum acceptable practices in
place.
• The first version of ISO 9000 was released in 1987
ISO 9000

• The ISO 9000 is a family of standards and guidelines related to the quality management system (QMS).
• It sets the requirements for the assurance of quality and for management’s involvement. The thrust of ISO 9000 is for organizations to
implement a QMS conforming to the standard’s requirements and, through the consistent, rigorous employment of the QMS, to :
1. Improve customer satisfaction by fulfilling customer requirements
2. Achieve continual improvement of organizational performance and competitiveness
3. Continually improve its processes, products, and services
4. Comply with regulatory requirements.

What are the main objectives and benefits of implementing ISO 9000 standards in an organization's Quality Management System
(QMS)?
ISO 9000

• It is important to note that ISO 9000 does not specify a level of quality or performance for any product or
service provided by an organization.That is left to the organization to determine with its customers
• The ISO 9000 is about standardizing the approach organizations everywhere use to manage and improve the
processes that ultimately result in their products and services.
• The ISO 9000 is applicable to any organization, whether in the private or the public sector, whether large or
small, and applies to those components of the organization that can have an impact on product or service
quality
• These typically include the departments responsible for engineering/ design, purchasing, manufacturing,
quality assurance, and delivery of the organization’s products and services.
ISO 9000

• When an organization demonstrates conformity to ISO 9000 to an independent (3rd party) registrar firm, the
registrar can certify (or register) the organization
• Registration provides assurance to customers worldwide that products or services from the organization can be
expected to consistently meet customer requirements.
• To maintain its registration, the organization must constantly strive to ensure that the QMS continues to
function effectively and that it is continually improved
• Registration may be lost if the registrar’s audits determine that the organization is not conforming to the
requirements of its registered QMS
The Eight Principles: ISO 9000’s Basis

• The ISO 9000 QMS is based on eight principles from total quality management (TQM):
1. Customer Focus. Understand the customer’s needs, meet the customer’s requirements, and strive to exceed
the customer’s expectations.
2. Leadership. Establish unity of purpose and organizational direction and provide an environment that promotes
employee involvement and achievement of objectives.
3. Involvement of People. Take advantage of fully involved employees, using all their abilities for the benefit of
the organization.
4. Process Approach. Recognize that things accomplished are the results of processes and that processes along
with related activities and resources must be managed.
5. System Approach to Management. The multiple interrelated processes that contribute to the
organization’s effectiveness are a system and should be managed as a system.
6. Continual Improvement. Continual improvement should be a permanent objective applied to the
organization and to its people, processes, systems, and products.
7. Factual Approach to Decision Making. Decisions must be based on the analysis of accurate, relevant, and
reliable data and information.
8. Mutually Beneficial Supplier Relationships. Both the organization and the supplier benefiting from one
another’s resources and knowledge results in value for all.
Plan–Do–Check–Act: ISO 9000’s Operating Principle

• Plan–Do–Check–Act is now the operating principle of ISO’s management system standards. Its function is to
operate in a never-ending loop
1. Plan. Establish objectives and develop the plans to achieve them.
2. Do. Put the plans into action.
3. Check. Measure the results of the action; that is, is the planned action working, or were the objectives met?
4. Act (or Adjust). Learn from the results of the third (Check) step, make any necessary changes to the plans,
and repeat the cycle.
ISO 9000’S OBJECTIVE
• The original aim of ISO 9000 was to ensure that the products or services provided by registered organizations
were consistently fit for their intended purpose.
• The ISO 9000 raised the standard’s aim to a new level.
• Customer focus and continual improvement, along with the other six quality management principles that have
been incorporated into the standard, are intended to make registered organizations more competitive.
HOW ISO 9000 IS APPLIED TO ORGANIZATIONS
• No organization is required by any government to use ISO 9000.
• Some government and corporate customers may well require their suppliers to be ISO 9000 registered (or at
least conforming), but usually whether to adopt the ISO 9000 QMS is strictly up to the organization’s
management.
THE BENEFITS OF ISO 9000 (Organizational Benefits)

• The ISO claims that beyond customer satisfaction, cost and risk-management benefits will also accrue to the
organization. These benefits translate to improved competitiveness the same as TQM’s objective
Customer Benefits
• Customers want products or services that meet their requirements, and they want them at a
competitive price.
• ISO 9000 can help the organization in both areas. Customer requirements will be met if the
organization listens to customers and designs and manufactures its products accordingly
• Prices can be more competitive because waste is minimized as improved processes become more
efficient, benefiting both the organization and its customers.
• Customers have increased confidence in the products and services of ISO 9000-registered
organizations because they know that appropriate quality management processes are employed
and that an independent registrar ensures that this continues to occur.
The Malcolm Baldrige National Quality
Award (MBNQA)
The Malcolm Baldrige National Quality Award (MBNQA)
• The Malcolm Baldrige National Quality Award (MBNQA) is an annual national award given to high-
performing organizations (or divisions).
• It was created to help US businesses focus on the systems and processes that would lead to excellent
performance and improve their global competitiveness.
• The MBNQA criteria provide a guide for developing management systems that can achieve high levels of
quality, productivity, customer satisfaction, and market success.
History and Applications

• In 1950, the Union of Japanese Scientists and Engineers instituted the annual Deming Prize to reward
companies showing excellence in product quality. The prize and its criteria, based on Dr. Deming’s teachings,
are believed to be a significant motivating factor in the “Japanese miracle”—the transformation of the Japanese
economy following World War II.
• In 1987, when such a transformation was desired for American businesses, a similar award was established by
an act of Congress, named after a recently- deceased Secretary of Commerce who believed strongly in the
importance of quality management to America’s prosperity and strength. The National Institute of Standards
and Technology (NIST) administers the award jointly with the American Society for Quality.
• Originally, awards could be given in three categories: manufacturing, service, and small business.
• Since 1999, awards also can be given in the categories of education and healthcare. Not all categories are
awarded every year, and some years there are multiple winners in a category
Criteria and Benefits

• The award criteria were not permanently fixed. Instead, they are continually reviewed and modified based on
proven practices of the best-performing companies in the world
• Factors considered are how widespread and broadly applicable a practice is and evidence of links to
performance results. Therefore, the MBNQA criteria are an up-to-date guide to the latest consensus on
management systems and practices that lead to performance excellence
• Many managers and organizations around the world use the criteria to help them build high-performing
management systems, without any intention of applying for the award.
• The MBNQA criteria have become a diagnostic tool to assess an organization’s status compared to best-in-
class and to identify areas for further work
• Not only do the criteria identify critical elements for creating a high-performing organization, but also winners
of the award must share detailed information on how they were able to change their cultures and achieve
success. One example of the results of this sharing is the Six Sigma process, developed by Motorola, recipient
of the MBNQA in 1988, and now used widely around the world.
The criteria of MALCOLM
BALDRIGE Award are:
1. Leaders drive the organization through leadership
2. strategic planning,
3. customer and market focus
4. Human Resource focus
5. Process management
6. Business result
7. Measurement & analysis
8. Many managers and organizations around the world use the criteria to help them build
high-performing management systems, without any intention of applying for the award
SIX SIGMA
Six Sigma

• It is an organization-wide approach used to achieve breakthrough improvements tied to significant bottom-line

results.
• Six Sigma specifies exactly how the organization’s managers should set up and lead the effort.
• Key features are the use of data and statistical analysis, highly trained project leaders known as Black Belts
and Green Belts, project selection based on estimated bottom-line results, and the dramatic goal of reducing
errors to about three per million opportunities.
• In the 1980s, Motorola realized that this was nowhere near adequate to meet their competition. They needed to
measure defects in parts per million. The company also realized that its quality problems were caused by the
way it managed the organization.
• Motorola developed and implemented Six Sigma Quality, a unique approach to dramatically improving quality.
In 1988, Motorola became one of the first winners of the new Malcolm Baldrige National Quality Award.
• Because winners are required to share their methods, Six Sigma Quality became public knowledge. Other
companies began using and improving on it, especially GE and AlliedSignal. In the 1990s and 2000s, it spread
to thousands of other organizations.
• Six Sigma programs have reported huge savings when applied to complex, even organization wide problems
that need breakthrough solutions.
• It is best focused on reducing variation in any major process from the production floor to headquarters offices.
• Customer requirements, defect prevention, and waste and cycle time reduction are the kinds of issues that Six
Sigma addresses
What Does Six Sigma Mean?

• Sigma—written with the Greek letter s—is a measure of a process’s variation or spread.
• The process is improved by making that spread smaller, producing output that is more consistent and has fewer
defects or errors.
known as DMAIC

• Define the improvement project’s goals, deriving them from customer needs or wants.
• Measure the current process and establish metrics to monitor progress toward goals.
• Analyze the current process to understand problems and their causes.
• Improve the process by identifying and piloting solutions to the problems.
• Control the improved process with standardization and ongoing monitoring.
LEAN MANUFACTURING
• Also called lean production, lean enterprise, or simply lean
• Lean manufacturing aims to maximize value for customers while minimizing waste in all forms, including
time, resources, and effort.
• It involves the continuous pursuit of efficiency and effectiveness by identifying and eliminating activities that
do not add value to the final product or service.
• Processes become faster and less expensive.
• Lean organizations are efficient, flexible, and highly responsive to customer needs.
• Although the principles, concepts, and tools of lean manufacturing are often credited to Taiichi Ohno, an
engineer at Toyota,
• The concepts of lean require changes in support functions such as product and process design, purchasing,
shipping, and, indeed, throughout the entire supply chain. An organization implementing lean concepts in all
these ways is called a lean enterprise.
• By addressing waste reduction, lean manufacturing efforts solve problems of cycle time reduction,
standardization, flexibility, and quick response to customer needs.
• It can be applied to all industries
Summary of LEAN MANUFACTURING FOCUSES ON SPEED
AND EFFICIENCY: ELIMINATING WASTE.

the previous
approaches
SIX SIGMA FOCUSES ON QUALITY: ELIMINATING MBNQA FOCUSES ON LEADERSHIP:
DEFECTS THROUGH REDUCED VARIATION. IMPLEMENTING MANAGEMENT
SYSTEMS FOR PERFORMANCE
EXCELLENCE.
Summary
of the
previous ISO 9000 FOCUSES ON CONSISTENCY: QUALITY FUNCTION DEPLOYMENT FOCUSES ON

approaches ELIMINATING UNPLEASANT SURPRISES THROUGH

STANDARDIZATION AND DISCIPLINE.
CUSTOMERS: CREATING PRODUCTS AND
SERVICES THEY WANT.
References

• The Quality Toolbox, Second Edition, Nancy R. Tague

• Quality Management for Organizational Excellence_ Introduction to Total Quality
• Fundamentals of Total Quality Management