Quality
Management
Lecture 7 – ISO 9000 and quality
control
doc.dr.sc. Marko Jurčević
prof.dr.sc. Roman Malarić
University of Zagreb
Faculty of Electrical Engineering and Computing
Department of Fundamentals of Electrical Engineering and Measurements, 2013
New Standards
• Management standards address the needs of organizations in
training, quality auditing and quality-management systems
• Increases in international trade during the 1980s created a need for
the development of universal standards of quality.
• Universal standards were seen as necessary in order for companies
to be able to objectively document their quality practices around the
world
• The International Standards Organization is dedicated to creating and
developing standards to help facilitate the international exchange of
goods and services. It consists of members from national standard
bodies of a number of different countries.
• Standardization has become required as a result of free market
economies that encourage diverse sources of supply. Fair competition
is created by creating identifiable, clearly defined common references
that are recognized worldwide
University of Zagreb, Faculty of Electrical Engineering and Computing, Department
of Fundamentals of Electrical Engineering and Measurements, 2013
Introduction
• The ISO 9000 Series is a set of international standards for
quality management and quality assurance
• ISO 9000 family addresses various aspects of quality
management and contains some of ISO’s best known
standards
• help companies effectively document the elements they need to
maintain an efficient quality system
• they are not specific to any one industry
• a lot of major purchasers require their suppliers to hold ISO
9001 certification
University of Zagreb, Faculty of Electrical Engineering and Computing, Department
of Fundamentals of Electrical Engineering and Measurements, 2013
• ISO 9000 can help a company satisfy its customers, meet
regulatory requirements and achieve continual improvement
• statistics shows significant financial benefits for organizations
certified to ISO 9001,
• a 2011 survey from the British Assessment Bureau showing 44%
of their certified clients had won new business
• www.british-assessment.co.uk/news/iso-9001-proven-to-help-winnew-business
• this is only a first step; many quality professionals will tell this is
the base level of a quality system and not a complete
guarantee of quality
University of Zagreb, Faculty of Electrical Engineering and Computing, Department
of Fundamentals of Electrical Engineering and Measurements, 2013
History of ISO 9000
• United States Department of Defense MIL-Q-9858 standard
was published in 1959.
• MIL-Q-9858 was revised into the NATO AQAP series of
standards in 1969, which in turn were revised into the BS 5179
series of guidance standards published in 1974, and finally
revised into the BS 5750 series of requirements standards in
1979
• ISO 9000 was first published in 1987. based on the BS 5750
series of standards from BSI (British Standards Institution)
proposed to ISO in 1979
University of Zagreb, Faculty of Electrical Engineering and Computing, Department
of Fundamentals of Electrical Engineering and Measurements, 2013
Evolution of ISO 9000 standards - 1987
• ISO 9000 standard is continually being revised by ISO technical committees
and advisory groups, who receive feedback from professionals implementing
the standard around the world
• ISO 9000:1987 - same structure as the UK Standard BS 5750
• three 'models' for quality management systems, based on the scope of
activities of the organization:
• ISO 9001:1987 Model for quality assurance in design, development,
production, installation, and servicing was for companies and organizations
whose activities included the creation of new products.
• ISO 9002:1987 Model for quality assurance in production, installation, and
servicing had basically the same material as ISO 9001 but without covering
the creation of new products.
• ISO 9003:1987 Model for quality assurance in final inspection and test
covered only the final inspection of finished product, with no concern for how
the product was produced.
• ISO 9000:1987 emphasis tended to be placed on conformance with
procedures rather than the overall process of management
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of Fundamentals of Electrical Engineering and Measurements, 2013
ISO 9000:1994
• ISO 9000:1994 emphasized quality assurance via preventive
actions, instead of just checking final product,
• also continued to require evidence of compliance with
documented procedures.
• the down-side was that companies tended to implement its
requirements by creating a lot of procedure manuals, and
becoming burdened with an ISO bureaucracy.
• In some companies, adapting and improving processes could
actually be impeded by the quality system
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of Fundamentals of Electrical Engineering and Measurements, 2013
ISO 9001:2000
• ISO 9001:2000 replaced all three former standards of 1994 issue, ISO 9001, ISO
9002 and ISO 9003.
• Design and development procedures were required only if a company does in
fact engage in the creation of new products.
• 2000 version made a radical change in thinking by actually placing the concept
of process management front and center ("Process management" was the
monitoring and optimisation of all company's tasks and activities, instead of just
final product inspection).
• 2000 version demanded involvement by upper executives in order to integrate
quality into the business system and avoid delegation of quality functions to
junior administrators.
• effectiveness improvement is done via process performance metrics:
numerical measurement of the effectiveness of tasks and activities.
• expectations of continual process improvement and tracking customer
satisfaction were made explicit.
• ISO 9000 Requirements include:
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(1) approve documents before distribution;
(2) provide correct version of documents at points of use;
(3) use your records to prove that requirements have been met;
(4) develop a procedure to control your records.
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of Fundamentals of Electrical Engineering and Measurements, 2013
ISO 9001:2008
• ISO 9001:2008 version introduced clarifications to the existing
requirements of ISO 9001:2000 and some changes intended to
improve consistency with ISO 14001:2004.
• there were no new requirements
• ISO 9001 is supplemented directly by two other standards of
the family:
• ISO 9000:2005 "Quality management systems. Fundamentals and
vocabulary"
• ISO 9004:2009 "Managing for the sustained success of an
organization. A quality management approach"
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of Fundamentals of Electrical Engineering and Measurements, 2013
ISO 9001:2015 ?
• ISO 9001 Quality Management Systems is under review and an updated
version is expected by the end of 2015.
• All ISO standards are reviewed every 5 years to make sure they remain as
helpful and relevant.
• http://www.iso.org/iso/home/news_index/news_archive/news.htm?refid=Ref1
633
University of Zagreb, Faculty of Electrical Engineering and Computing, Department
of Fundamentals of Electrical Engineering and Measurements, 2013
ISO 9000 Contents
• as already stated, there are several standards in the ISO 9000 family
• ISO 9001:2008 Quality management systems — Requirements is a
PDF/paper document (has approx. 30 pages) which is available from
the national standards organization in each country or over the ISO
web site
• only this is directly audited against for third party assessment purposes
• it is supplemented by two other standards:
• ISO 9000:2005 Quality management systems — Fundamentals and
vocabulary and
• ISO 9004:2009 Managing for the sustained success of an organization —
A quality management approach.
• these two standards are only supplementary documents and contain
deeper information on how to sustain and improve quality management
systems
• they are therefore not used directly during third party assessment but
only serve as an additional help
• ISO 19011:2011 - sets out guidance on internal and external audits of
quality management systems
University of Zagreb, Faculty of Electrical Engineering and Computing, Department
of Fundamentals of Electrical Engineering and Measurements, 2013
ISO 9001 Contents
• ISO 9001 is made up of eight sections:
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scope,
normative reference,
terms and definitions,
quality management system,
management responsibility,
resource management,
product realization and
measurement, analysis and improvement
• first three sections provide general information about the
standard, and the last five focus on how to implement it
University of Zagreb, Faculty of Electrical Engineering and Computing, Department
of Fundamentals of Electrical Engineering and Measurements, 2013
• Section 1—scope: specifies that the organization needs to
meet customer and regulatory requirements and ensure its
employees follow its policies and procedures while advancing
quality through continual improvement.
• Section 2—normative reference: provides normative
references—to constitute the terms of ISO 9001.
• Section 3—terms and definitions: defines the terms used in the
standard and highlights the differences between the 2008
version and older (2000) version.
University of Zagreb, Faculty of Electrical Engineering and Computing, Department
of Fundamentals of Electrical Engineering and Measurements, 2013
• Section 4—quality management system: describes the
standard’s general requirements, which encompass all activities
from quality manual documentation and control of documents
and records to determining the sequence and interaction of the
processes to implementing actions to achieve planned results
• Section 5—management responsibility: requires management’s
commitment to the QMS and explains that management must
be dedicated to the organization’s products, customers and
planning and review processes
University of Zagreb, Faculty of Electrical Engineering and Computing, Department
of Fundamentals of Electrical Engineering and Measurements, 2013
• Section 6—resource management: provides the criteria needed
to perform a job competently and in a safe environment. Human
resources, infrastructure planning and work environment are
discussed in this section.
• Section 7—product realization: defines the steps in product
development. These steps include everything from the initial
design phase to the final delivery phase.
• For example: product realization planning, customer related
processes, design and development, the product purchasing
process, production and service provisions and the control of
monitoring and measuring devices.
University of Zagreb, Faculty of Electrical Engineering and Computing, Department
of Fundamentals of Electrical Engineering and Measurements, 2013
• Section 8—measurement, analysis and improvement: focuses
on measuring, analyzing and improving the QMS by having
companies perform periodical internal audits, monitor customer
satisfaction, control nonconforming product, analyze data and
take corrective and preventive actions.
University of Zagreb, Faculty of Electrical Engineering and Computing, Department
of Fundamentals of Electrical Engineering and Measurements, 2013
ISO 9001 Table of Contents
• Page iv: Foreword
• Pages v to vii: Section 0 Intro
• Pages 1 to 14: Requirements
• Section 1: Scope
• Section 2: Normative Reference
• Section 3: Terms and definitions (specific to ISO 9001, not specified in
ISO 9000)
• Section 4: Quality Management System
• Section 5: Management Responsibility
• Section 6: Resource Management
• Section 7: Product Realization
• Section 8: Measurement, analysis and improvement
• Pages 15 to 22: Tables of Correspondence between ISO 9001 and
other standards
• Page 23: Bibliography
University of Zagreb, Faculty of Electrical Engineering and Computing, Department
of Fundamentals of Electrical Engineering and Measurements, 2013
ISO 9001 Chapter Numbering
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4.2 Documentation requirements
5 Management responsibility
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6 Resource management
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6.1 Provision of resources
6.2 Human resources
6.3 Infrastructure
6.4 Work environment
7 Product realization
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5.1 Management commitment
5.2 Customer focus
5.3 Quality policy
5.4 Planning
5.5 Responsibility, authority and communication
5.6 Management review
7.1 Planning of product realization
7.2 Customer-related processes
7.3 Design and development
7.4 Purchasing
7.5 Production and service provision
7.6 Control of monitoring and measuring equipment
8 Measurement, analysis and improvement
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8.1 General
8.2 Monitoring and measurement
8.3 Control of nonconforming product
8.4 Analysis of data
8.5 Improvement
University of Zagreb, Faculty of Electrical Engineering and Computing, Department
of Fundamentals of Electrical Engineering and Measurements, 2013
ISO 9001 Basic Implementation Guidelines
• Before the certification body can issue or renew a certificate, the auditor must be
satisfied that the company being assessed has implemented the requirements of
sections 4 to 8.
• The standard specifies that the organization shall issue and maintain the
following six documented procedures:
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Control of Documents (4.2.3)
Control of Records (4.2.4)
Internal Audits (8.2.2)
Control of Nonconforming Product / Service (8.3)
Corrective Action (8.5.2)
Preventive Action (8.5.3)
• ISO 9001:2008 requires the organization to document any other additional
procedures required for its effective operation.
• standard requires the organization to issue and communicate a documented
quality policy, a Quality Manual (which may or may not include the documented
procedures) and numerous records, as specified throughout the standard.
University of Zagreb, Faculty of Electrical Engineering and Computing, Department
of Fundamentals of Electrical Engineering and Measurements, 2013
ISO 9000 Auditing
• AUDITING – useful for continual process of review and
assessment to verify that the system is working as it is
supposed to, to find out where it can improve and to correct or
prevent problems identified
• Two types of auditing are required to become certified to the
standard:
• auditing by an external certification body (external audit) and
• audits by internal staff trained for this process (internal audits)
• Auditors:
• are expected to go beyond auditing for rote compliance by
focusing on risk, status, and importance
• are expected to make judgments on what is effective, rather than
merely adhering to what is formally prescribed
University of Zagreb, Faculty of Electrical Engineering and Computing, Department
of Fundamentals of Electrical Engineering and Measurements, 2013
ISO 9001 Certification
• ISO does not certify organizations itself
• there are certification bodies (specialized companies), which
audit organizations and, if successful, issue ISO 9001
compliance certificates
• national accreditation bodies authorize (or accredit) the
certification bodies
• don’t adapt or modify ISO’s logo for your use
University of Zagreb, Faculty of Electrical Engineering and Computing, Department
of Fundamentals of Electrical Engineering and Measurements, 2013
ISO 9001 process-based approach
• to ease implementation, ISO 9001 suggests companies adopt a
process approach, which is a series of operations that
transform inputs into value added output
• process can be measured by accuracy, timeliness, cycle time,
downtime, efficiency, effectiveness, turnaround and setup time
• To achieve certification, a company must:
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follow the guidelines of the ISO 9001 standard
fulfill its own requirements and those of its customers
follow statutory and regulatory requirements
create documents
keep track of record
University of Zagreb, Faculty of Electrical Engineering and Computing, Department
of Fundamentals of Electrical Engineering and Measurements, 2013
ISO 9001 Certification
• organization that applies for ISO 9001 certification is audited based
on an extensive sample of its locations, functions, products, services
and processes
• auditor presents a list of problems (defined as nonconformities,
observations) to management.
• in a case of no major nonconformities, the certification body issues a
certificate
• in a case of identified nonconformities, the applicant organization will
present an improvement plan to the certification body (e.g. corrective
action reports showing how the problems will be resolved)
• once the certification body is satisfied that the organization has carried
out sufficient corrective action, it will issue a certificate
• the certificate is limited by a certain scope (e.g. production of power
meters) and will display the addresses to which the certificate refers
• must be renewed at regular intervals recommended by the
certification body (usually once every three years)
University of Zagreb, Faculty of Electrical Engineering and Computing, Department
of Fundamentals of Electrical Engineering and Measurements, 2013
ISO9001 Benefits
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creates a more efficient, effective operation/processes
increases customer satisfaction and retention
reduces audits
enhances marketing
improves employee motivation, awareness, and morale
promotes international trade
increases profit
reduces waste and increases productivity
common tool for standardization.
University of Zagreb, Faculty of Electrical Engineering and Computing, Department
of Fundamentals of Electrical Engineering and Measurements, 2013
Some statistics - Global adoption
Worldwide total of ISO 9001 - Quality Management Systems - Requirements certificates
Dec
2001
Dec
2002
Dec
2003
Dec
2004
Dec
2005
Dec
2006
Dec
2007
Dec
2008
Dec
2009
Dec
2010
Dec
2011
510,349
561,767
497,919
660,132
773,867
896,929
951,486
982,832
1,064,785
1,118,510
1,111,698
Source: ISO Survey 2011
University of Zagreb, Faculty of Electrical Engineering and Computing, Department
of Fundamentals of Electrical Engineering and Measurements, 2013
Some statistics
Top 10 countries for ISO 9001 certificates - 2010
Rank
Country
No. of certificates
1
China
297,037
2
Italy
138,892
3
Russian Federation
62,265
4
Spain
59,854
5
Japan
59,287
6
Germany
50,583
7
United Kingdom
44,849
8
India
33,250
9
USA
25,101
10
Korea, Republic of
24,778
University of Zagreb, Faculty of Electrical Engineering and Computing, Department
of Fundamentals of Electrical Engineering and Measurements, 2013
Source: ISO Survey 2011
References
• ISO Central Secretariat, Publicizing your ISO 9001:2008 or ISO
14001:2004 certification, www.iso.org, 2010.
• ISO 9000 - Quality management,
http://www.iso.org/iso/iso9000-14000/understand/iso_9000
• ISO 9000 and Other Standards - Read More
http://asq.org/learn-about-quality/iso-9000/overview/readmore.html
• ISO 9000, http://en.wikipedia.org/wiki/ISO_9000
University of Zagreb, Faculty of Electrical Engineering and Computing, Department
of Fundamentals of Electrical Engineering and Measurements, 2013
Quality
Management
Lecture 8 – Total Quality Management
doc.dr.sc. Marko Jurčević
prof.dr.sc. Roman Malarić
University of Zagreb
Faculty of Electrical Engineering and Computing
Department of Fundamentals of Electrical Engineering and Measurements, 2013
History
• in the late 1970s and early 1980s, the developed countries of North America and
Western Europe suffered economically in the face of competition from Japan's
ability to produce high-quality goods at competitive cost
• the companies began re-examining the techniques of quality control invented
over the past 50 years and how those techniques had been so successfully
employed by the Japanese
• In the spring of 1984, some of the United States Navy researchers assess
statistical process control and introduced the work of several prominent quality
consultants to make recommendations as to how to apply their approaches to
improve the Navy's operational effectiveness. The recommendation was to adopt
the teachings of W. Edwards Deming. This effort was branded as "Total Quality
Management" in 1985.
• TQM spread throughout the US Federal Government, resulting in the following:
• the creation of the Malcolm Baldrige National Quality Award in 1987
• the creation of the Federal Quality Institute in 1988
• the adoption of TQM by many elements of government
• the private sector followed using TQM not only as a means to recapture market
share from the Japan, but also to remain competitive when bidding for contracts
from the government since "total quality" requires involving suppliers, not just
employees, in process improvement efforts
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of Fundamentals of Electrical Engineering and Measurements, 2013
TQM Intro
• core definition of total quality management (TQM) describes a
management approach to long–term success through customer
satisfaction.
• consists of organization-wide efforts to install and make
permanent a climate in which an organization continuously
improves its ability to deliver high-quality products and services
to customers, but there is no widely agreed-upon approach
• all members of an organization participate in improving
processes, products, services, and the culture in which they
work.
• methods for implementing this approach come from the
teachings of such quality leaders as Philip B. Crosby, W.
Edwards Deming, Armand V. Feigenbaum, Kaoru Ishikawa, and
Joseph M. Juran.
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of Fundamentals of Electrical Engineering and Measurements, 2013
TQM Elements
• TQM uses strategy, data and effective communications to
integrate the quality discipline into the culture and activities of
the organization
• These TQM elements are considered essential to successfull
TQM that many organizations define them as a set of core
values and principles on which the organization is to operate:
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Customer-focused
Total employee involvement
Process-centered
Integrated system
Strategic and systematic approach
Continual improvement
Fact-based decision making
Communications
University of Zagreb, Faculty of Electrical Engineering and Computing, Department
of Fundamentals of Electrical Engineering and Measurements, 2013
Customer focus
• The customer ultimately determines the level of quality.
• it is not so important what an organization does to foster quality
improvement—training employees, integrating quality into the
design process, upgrading computers or software, or buying
new measuring tools—the customer determines whether the
efforts were effective.
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of Fundamentals of Electrical Engineering and Measurements, 2013
Total employee involvement
• all employees participate in working toward common goals.
• total employee commitment can only be obtained after fear has
been driven from the workplace, when empowerment has
occurred, and management has provided the proper
environment.
• High-performance work systems integrate continuous
improvement efforts with normal business operations.
• Self-managed work teams are one form of empowerment.
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of Fundamentals of Electrical Engineering and Measurements, 2013
Process-centered
• fundamental part of TQM is a focus on process thinking.
• process is a series of steps that take inputs from suppliers
(internal or external) and transforms them into outputs that are
delivered to customers (again, either internal or external).
• the steps required to carry out the process are defined, and
performance measures are continuously monitored in order to
detect unexpected variation.
University of Zagreb, Faculty of Electrical Engineering and Computing, Department
of Fundamentals of Electrical Engineering and Measurements, 2013
Integrated system
• an organization may consist of many different functional specialties often
organized into vertically structured departments
• the horizontal processes are interconnecting these functions that are the
focus of TQM
• micro-processes add up to larger processes
• all processes aggregate into the business processes required for defining
and implementing strategy.
• everyone must understand the vision, mission, and guiding principles as well
as the quality policies, objectives, and critical processes of the organization.
• business performance must be monitored and communicated continuously.
• an integrated business system may be modeled after the Baldrige National
Quality Program criteria and/or incorporate the ISO 9000 standards.
• every organization has a unique work culture, and it is virtually impossible to
achieve excellence in its products and services unless a good quality culture
has been fostered.
• an integrated system connects business improvement elements in an
attempt to continually improve and exceed the expectations of customers,
employees, and other stakeholders.
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of Fundamentals of Electrical Engineering and Measurements, 2013
Strategic and systematic approach
• critical part of the management of quality is the strategic and
systematic approach to achieving an organization’s vision,
mission, and goals.
• this process, called strategic planning or strategic
management, includes the formulation of a strategic plan that
integrates quality as a core component.
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of Fundamentals of Electrical Engineering and Measurements, 2013
Continual improvement
• major thrust of TQM is continual process improvement.
• continual improvement drives an organization to be both
analytical and creative in finding ways to become more
competitive and more effective at meeting stakeholder
expectations.
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of Fundamentals of Electrical Engineering and Measurements, 2013
Fact-based decision making
• in order to know how well an organization is performing, data
on performance measures are necessary.
• TQM requires that an organization continually collect and
analyse data in order to improve decision making accuracy,
achieve consensus, and allow prediction based on past history.
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of Fundamentals of Electrical Engineering and Measurements, 2013
Communications
• during times of organizational change, as well as part of day-today operation, effective communications plays a large part in
maintaining morale and in motivating employees at all levels.
• communications involve strategies, method, and timeliness.
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of Fundamentals of Electrical Engineering and Measurements, 2013
Implementing a TQM System
• Generic steps for implementing TQM:
• top management learns about and decides to commit to TQM as it is identified as one
of the organization’s strategies
• the organization assesses current culture, customer satisfaction and quality
management systems
• top management identifies core values and principles to be used and communicates
them
• a TQM master plan is developed on the basis of steps 1, 2, and 3
• the organization identifies and prioritizes customer demands and aligns products and
services to meet those demands
• management maps the critical processes through which the organization meets its
customers’ needs
• management oversees the formation of teams for process improvement efforts
• the momentum of the TQM effort is managed by the steering committee
• managers contribute individually to the effort through planning, training, coaching, or
other methods
• daily process management and standardization take place
• progress is evaluated and the plan is revised as needed
• constant employee awareness and feedback on status are provided and a
reward/recognition process is established
• of course, the TQM strategy will vary from organization to organization
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of Fundamentals of Electrical Engineering and Measurements, 2013
Strategies to develop the TQM process
• following strategies as stated in Certified Manager of
Quality/Organizational Excellence Handbook, pages 306-307
• Strategy 1: The TQM element approach
• takes key business processes and/or organizational units and
uses the tools of TQM to foster improvements. This method was
widely used in the early 1980s as companies tried to implement
parts of TQM as they learned them.
• examples of this approach include quality circles, statistical
process control, Taguchi methods, and quality function deployment
University of Zagreb, Faculty of Electrical Engineering and Computing, Department
of Fundamentals of Electrical Engineering and Measurements, 2013
Strategies to develop the TQM process
• Strategy 2: The guru approach
• uses the teachings and writings of one or more of the leading
quality thinkers as a guide against which to determine where the
organization has deficiencies. Then, the organization makes
appropriate changes to remedy those deficiencies.
• example: managers might study Deming’s 14 points or attend the
Crosby College. They would then work on implementing the
approach learned.
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of Fundamentals of Electrical Engineering and Measurements, 2013
Strategies to develop the TQM process
• Strategy 3: The organization model approach
• individuals or teams visit organizations that have taken a
leadership role in TQM and determine their processes and reasons
for success. They then integrate these ideas with their own ideas
to develop an organizational model adapted for their specific
organization.
• this method was used widely in the late 1980s and is exemplified
by the initial recipients of the Malcolm Baldrige National Quality
Award.
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of Fundamentals of Electrical Engineering and Measurements, 2013
Strategies to develop the TQM process
• Strategy 4: The Japanese total quality approach
• organizations using the Japanese total quality approach examine
the detailed implementation techniques and strategies employed
by Deming Prize–winning companies and use this experience to
develop a long-range master plan for in-house use.
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of Fundamentals of Electrical Engineering and Measurements, 2013
Strategies to develop the TQM process
• Strategy 5: The award criteria approach
• when using this model, an organization uses the criteria of a
quality award, for example, the Deming Prize, the European
Quality Award, or the Malcolm Baldrige National Quality Award, to
identify areas for improvement. Under this approach, TQM
implementation focuses on meeting specific award criteria.
• although some argue that this is not an appropriate use of award
criteria, some organizations do use this approach and it can result
in improvement.
University of Zagreb, Faculty of Electrical Engineering and Computing, Department
of Fundamentals of Electrical Engineering and Measurements, 2013
Benefits
• direct and indirect benefits that total quality management (TQM) can
offer organizations:
• strengthened competitive position
• adaptability to changing or emerging market conditions and to
environmental and other government regulations
• higher productivity
• enhanced market image
• elimination of defects and waste
• reduced costs and better cost management
• higher profitability
• improved customer focus and satisfaction
• increased customer loyalty and retention
• increased job security
• improved employee morale
• enhanced shareholder and stakeholder value
• improved and innovative processes
University of Zagreb, Faculty of Electrical Engineering and Computing, Department
of Fundamentals of Electrical Engineering and Measurements, 2013
References
• ASQ, Total Quality Management (TQM), http://asq.org/learnabout-quality/total-quality-management/overview/overview.html,
2013.
• Russell T. Westcott, editor: Certified Manager of
Quality/Organizational Excellence Handbook, pages 306-307.
• D.L. Goetsch, S.B. Davis: Quality Management: Introduction to
Total Quality Management for Production, Processing, and
Services (5th edition), Prentice Hall, 2006.
• James R. Evans, James W. Dean, Jr.: Total Quality
Management, Thomson Learning, 2004.
• John S. Oakland: Total Quality Management: Text with Cases,
Butterworth-Heinemann, 2000.
• http://en.wikipedia.org/wiki/Total_quality_management
University of Zagreb, Faculty of Electrical Engineering and Computing, Department
of Fundamentals of Electrical Engineering and Measurements, 2013
Quality
Management
Lecture 9 – Quality Management
Programs
doc.dr.sc. Marko Jurčević
prof.dr.sc. Roman Malarić
University of Zagreb
Faculty of Electrical Engineering and Computing
Department of Fundamentals of Electrical Engineering and Measurements, 2013
Quality Management Programs
• International Standards:
• example ISO 9000
• ...
• Quality Management Programs:
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Six Sigma (6s)
Malcolm Baldrige National Program
EFQM Excellence Model
The Deming Prize Award
many others
University of Zagreb, Faculty of Electrical Engineering and Computing, Department
of Fundamentals of Electrical Engineering and Measurements, 2013
Six Sigma
• Six Sigma is a set of techniques, and tools for process
improvement
• a fact-based, data-driven philosophy of quality improvement
that values defect prevention over defect detection
• developed by Motorola in 1986
University of Zagreb, Faculty of Electrical Engineering and Computing, Department
of Fundamentals of Electrical Engineering and Measurements, 2013
Six Sigma
• drives customer satisfaction and bottom-line results by reducing
variation and waste, thereby promoting a competitive
advantage.
• it applies anywhere variation and waste exist, and every
employee should be involved
• Six Sigma quality performance means no more than 3.4 defects
per million opportunities (products, events, services, ...)
• uses a set of quality management methods, including statistical
methods, and creates a special infrastructure of people within
the organization ("Champions", "Black Belts", "Green Belts",
"Yellow Belts", etc.) who are experts in the methods.
University of Zagreb, Faculty of Electrical Engineering and Computing, Department
of Fundamentals of Electrical Engineering and Measurements, 2013
Opinions on the definition of Six Sigma
• Six Sigma is a philosophy — This perspective views all work as processes
that can be defined, measured, analyzed, improved and controlled.
Processes require inputs (x) and produce outputs (y). If you control the
inputs, you will control the outputs: This is generally expressed as y = f(x).
• Six Sigma is a set of tools — The Six Sigma expert uses qualitative and
quantitative techniques to drive process improvement. A few such tools
include statistical process control (SPC), control charts, failure mode and
effects analysis and flowcharting.
• Six Sigma is a methodology — This view of Six Sigma recognizes the
underlying and rigorous approach known as DMAIC (define, measure,
analyze, improve and control). DMAIC defines the steps a Six Sigma
practitioner is expected to follow, starting with identifying the problem and
ending with the implementation of long-lasting solutions. While DMAIC is not
the only Six Sigma methodology in use, it is certainly the most widely
adopted and recognized.
Excerpted from Donald W. Benbow and T. M. Kubiak, The Certified Six Sigma
Black Belt Handbook, ASQ Quality Press, 2005, pages 1–2.
University of Zagreb, Faculty of Electrical Engineering and Computing, Department
of Fundamentals of Electrical Engineering and Measurements, 2013
Six Sigma
• term Six Sigma originated from terminology
associated with manufacturing, specifically
terms associated with statistical modeling of
manufacturing processes
• maturity of a manufacturing process can be
described by a sigma rating indicating its
yield or the percentage of defect-free
products it creates
• processes that operate with "six sigma
quality" over the short term are assumed to
produce long-term defect levels below 3.4
defects per million opportunities (DPMO)
University of Zagreb, Faculty of Electrical Engineering and Computing, Department
of Fundamentals of Electrical Engineering and Measurements, 2013
Six Sigma
• six sigma process
• if one has six standard deviations between the process mean
and the nearest specification limit, as shown in the graph,
practically no items will fail to meet specifications
University of Zagreb, Faculty of Electrical Engineering and Computing, Department
of Fundamentals of Electrical Engineering and Measurements, 2013
• on the previous slide, graph of the normal distribution is shown, which
underlies the statistical assumptions of the Six Sigma model.
• the Greek letter σ (sigma) marks the distance on the horizontal axis between
the mean, µ, and the curve's inflection point
• the greater this distance, the greater is the spread of values encountered
• the upper and lower specification limits (U/USL and L/LSL, respectively) are
at a distance of 6σ from the mean
• because of the properties of the normal distribution, values lying that far
away from the mean are extremely unlikely
• experience has shown that processes usually do not perform as well in the
long term as they do in the short term. The number of sigmas that will fit
between the process mean and the nearest specification limit may well drop
over time, compared to an initial short-term analysis.To account for this reallife increase in process variation over time, an empirically-based 1.5 sigma
shift is introduced into the calculation
• even if the mean were to move right or left by 1.5σ at some point in the future
(1.5 sigma shift), there is still a good safety zone
• this is why Six Sigma aims to have processes where the mean is at most 6σ
away from the nearest specification limit
University of Zagreb, Faculty of Electrical Engineering and Computing, Department
of Fundamentals of Electrical Engineering and Measurements, 2013
Software used for Six Sigma
• Some well-known programs used for six-sigma data analysis:
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Mathematica
MATLAB or GNU Octave
Microsoft Visio
Minitab
Origin (software)
SDI Tools
SigmaXL
STATISTICA
University of Zagreb, Faculty of Electrical Engineering and Computing, Department
of Fundamentals of Electrical Engineering and Measurements, 2013
Six Sigma
• Six Sigma's implicit goal is to improve all processes, (but not to
the 3.4 DPMO level necessarily).
• organizations need to determine an appropriate sigma level for
each of their important processes and strive to achieve these
• it is up to management of the organisation to prioritize areas of
improvement
• ISO has published ISO 13053:2011 defining the six sigma
process
University of Zagreb, Faculty of Electrical Engineering and Computing, Department
of Fundamentals of Electrical Engineering and Measurements, 2013
Six Sigma
• Six Sigma projects follow two project methodologies inspired by
Deming's Plan-Do-Check-Act (PDCA) Cycle.
• these methodologies, composed of five phases each, bear the
acronyms DMAIC and DMADV:
• DMAIC is used for projects aimed at improving an existing
business process
• DMADV is used for projects aimed at creating new product or
process designs
University of Zagreb, Faculty of Electrical Engineering and Computing, Department
of Fundamentals of Electrical Engineering and Measurements, 2013
Six Sigma
• DMAIC project methodology has five phases:
• Define the system, the voice of the customer and their requirements, and
the project goals, specifically.
• Measure key aspects of the current process and collect relevant data.
• Analyze the data to investigate and verify cause-and-effect relationships.
Determine what the relationships are, and attempt to ensure that all
factors have been considered. Seek out root cause of the defect under
investigation.
• Improve or optimize the current process based upon data analysis using
techniques such as design of experiments, poka yoke or mistake
proofing, and standard work to create a new, future state process. Set up
pilot runs to establish process capability.
• Control the future state process to ensure that any deviations from target
are corrected before they result in defects. Implement control systems
such as statistical process control, production boards, visual workplaces,
and continuously monitor the process.
• more info about Six Sigma DMAIC tools can be found here:
http://www.isixsigma.com/new-to-six-sigma/dmaic/six-sigma-dmaicroadmap/
University of Zagreb, Faculty of Electrical Engineering and Computing, Department
of Fundamentals of Electrical Engineering and Measurements, 2013
Six Sigma
• The DMADV project methodology has also five phases:
• Define design goals that are consistent with customer
demands/enterprise strategy
• Measure and identify CTQs (characteristics that are Critical To
Quality), product capabilities, production process capability, and
risks
• Analyze to develop and design alternatives
• Design an improved alternative, best suited per analysis in the
previous step
• Verify the design, set up pilot runs, implement the production
process and hand it over to the process owner(s)
University of Zagreb, Faculty of Electrical Engineering and Computing, Department
of Fundamentals of Electrical Engineering and Measurements, 2013
Six Sigma
• Quality management tools and methods used in Six Sigma:
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5 Whys
Analysis of variance
Axiomatic design
Business Process Mapping
Control chart
Cost-benefit analysis
Design of experiments
Histograms
Pareto chart
Process capability
Quality Function Deployment (QFD)
Scatter diagram
Taguchi Loss Function
University of Zagreb, Faculty of Electrical Engineering and Computing, Department
of Fundamentals of Electrical Engineering and Measurements, 2013
Six Sigma Belts, Executives and Champions
• Six Sigma professionals exist at every level – each with a different role to
play
• absolute "professionalizing" of quality management functions
• at the project level, there are black belts, master black belts, green belts,
yellow belts and white belts. These people conduct projects and implement
improvements.
• Black Belt: Leads problem-solving projects. Trains and coaches project
teams.
• Green Belt: Assists with data collection and analysis for Black Belt projects.
Leads Green Belt projects or teams.
• Master Black Belt: Trains and coaches Black Belts and Green Belts.
Functions more at the Six Sigma program level by developing key metrics
and the strategic direction. Acts as an organization’s Six Sigma technologist
and internal consultant.
• Yellow Belt: Participates as a project team member. Reviews process
improvements that support the project.
• White Belt: Can work on local problem-solving teams that support overall
projects, but may not be part of a Six Sigma project team. Understands basic
Six Sigma concepts from an awareness perspective.
University of Zagreb, Faculty of Electrical Engineering and Computing, Department
of Fundamentals of Electrical Engineering and Measurements, 2013
Six Sigma Belts, Executives and Champions
• provide organizational support for project.
• Six Sigma executives and champions set the direction for
selecting and deploying projects.
• They ensure, at a high level, that projects succeed, add value
and fit within the organizational plan.
• Champions: Translate the company’s vision, mission, goals and
metrics to create an organizational deployment plan and identify
individual projects. Identify resources and remove roadblocks.
• upper management
• Executives: Provide overall alignment by establishing the
strategic focus of the Six Sigma program within the context of the
organization’s culture and vision.
• CEO and other members of top management
University of Zagreb, Faculty of Electrical Engineering and Computing, Department
of Fundamentals of Electrical Engineering and Measurements, 2013
Advantages of Six Sigma & ISO 9000
• Six Sigma mostly finds application in large organizations
• ISO 9000 and Six Sigma are two systems for measuring and
assessing a quality management process
• Six Sigma may be a more affordable option for smaller
businesses as it is not as standardized as ISO 9000, meaning
there is a wider range of formal to informal verification services
available
http://smallbusiness.chron.com/advantages-six-sigma-iso-9000small-firms-14196.html
University of Zagreb, Faculty of Electrical Engineering and Computing, Department
of Fundamentals of Electrical Engineering and Measurements, 2013
MBNQA
• Malcolm Baldrige National Quality Award
• formal recognition of the performance excellence of both public
and private U.S. organizations
• administered by the Baldrige Performance Excellence Program,
which is based at and managed by the National Institute of
Standards and Technology (NIST)
• established by US Congress in 1987 for manufacturers, service
businesses and small businesses
• designed to raise awareness of quality management and
recognize U.S. companies that have implemented successful
quality-management systems
• the Baldrige Award is named after the late Secretary of
Commerce Malcolm Baldrige, a proponent of quality
management
University of Zagreb, Faculty of Electrical Engineering and Computing, Department
of Fundamentals of Electrical Engineering and Measurements, 2013
MBNQA
• three awards may be given annually in each of six categories:
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Manufacturing
Service company
Small business
Education
Healthcare
Nonprofit
• organizations that apply for the Baldrige Award are judged by
an independent board of examiners (volunteers).
University of Zagreb, Faculty of Electrical Engineering and Computing, Department
of Fundamentals of Electrical Engineering and Measurements, 2013
MBNQA
• MBNQA recipients are selected based on achievement and improvement in
seven areas, known as the Baldrige Criteria for Performance Excellence:
• Leadership: How upper management leads the organization, and how the
organization leads within the community (120 points)
• Strategic planning: How the organization establishes and plans to implement
strategic directions (85 points)
• Customer and market focus: addresses how the company collects market and
customer information. Successful companies should use a variety of tools toward this
end, such as market surveys and focus groups. The company then needs to
demonstrate how it acts on this information (85 points)
• Measurement, analysis, and knowledge management: Examiners evaluate how
the company obtains data and how it acts on the information. The company needs to
demonstrate how the information is shared within the company as well as with other
parties, such as suppliers and customers (90 points)
• Human resource focus: How the organization empowers and involves its workforce
(85 points)
• Process management: How the organization designs, manages and improves key
processes (85 points)
• Business/organizational performance results: How the organization performs in
terms of customer satisfaction, finances, human resources, supplier and partner
performance, operations, governance and social responsibility, and how the
organization compares to its competitors (450 points)
University of Zagreb, Faculty of Electrical Engineering and Computing, Department
of Fundamentals of Electrical Engineering and Measurements, 2013
MBNQA
• to receive a Baldrige Award, an organization must have a rolemodel organizational management system that ensures
continuous improvement in delivering products and/or services,
demonstrates efficient and effective operations, and provides a
way of engaging and responding to customers and other
stakeholders.
• the award is not given for specific products or services
• more info at: http://www.nist.gov/baldrige/
University of Zagreb, Faculty of Electrical Engineering and Computing, Department
of Fundamentals of Electrical Engineering and Measurements, 2013
EFQM
• European Foundation for Quality Management:
• non-profit membership foundation in Brussels
• was established in 1989 to increase the competitiveness of the
European economy, with 67 members
• first version of the EFQM Excellence Model was created by a
group of experts from various sectors and academic institutions
and launched in 1992
University of Zagreb, Faculty of Electrical Engineering and Computing, Department
of Fundamentals of Electrical Engineering and Measurements, 2013
EFQM Model
http://www.efqm.org/efqm-model/fundamental-concepts
• Fundamentals Concepts are shown on this picture
University of Zagreb, Faculty of Electrical Engineering and Computing, Department
of Fundamentals of Electrical Engineering and Measurements, 2013
EFQM Concepts
• 8 Fundamentals Concepts for excellent organisations:
• Adding Value for Customers - consistently add value for
customers by understanding, anticipating and fulfilling needs,
expectations and opportunities
• Creating a Sustainable Future - have a positive impact on the
world around them by enhancing their performance whilst
simultaneously advancing the economic, environmental and social
conditions within the communities they touch.
• Developing Organisational Capability - enhance their
capabilities by effectively managing change within and beyond the
organisational boundaries
• Harnessing Creativity & Innovation - generate increased value
and levels of performance through continual improvement and
systematic innovation by harnessing the creativity of their
stakeholders.
University of Zagreb, Faculty of Electrical Engineering and Computing, Department
of Fundamentals of Electrical Engineering and Measurements, 2013
EFQM Concepts
• 8 Fundamentals Concepts (... continued):
• Leading with Vision, Inspiration & Integrity - have leaders who
shape the future and make it happen, acting as role models for its
values and ethics.
• Managing with Agility - are widely recognised for their ability to
identify and respond effectively and efficiently to opportunities and
threats.
• Succeeding through the Talent of People - value their people
and create a culture of empowerment for the achievement of both
organisational and personal goals.
• Sustaining Outstanding Results - achieve sustained outstanding
results that meet both the short and long term needs of all their
stakeholders, within the context of their operating environment.
University of Zagreb, Faculty of Electrical Engineering and Computing, Department
of Fundamentals of Electrical Engineering and Measurements, 2013
EFQM Model Criteria
• can be applied to any organisation, regardless of size, sector or maturity
• non-prescriptive and it takes into account a number of different concepts
• EFQM Excellence Model is based on nine criteria. Five of these are
"Enablers" and four are "Results".
University of Zagreb, Faculty of Electrical Engineering and Computing, Department
of Fundamentals of Electrical Engineering and Measurements, 2013
EFQM Model
• The "Enabler" criteria cover what an organisation does and how
it does it.
• The "Results" criteria cover what an organisation achieves.
• arrows on the picture emphasise the dynamic nature of the
Model, showing learning, creativity and innovation helping to
improve the Enablers that in turn lead to improved Results.
University of Zagreb, Faculty of Electrical Engineering and Computing, Department
of Fundamentals of Electrical Engineering and Measurements, 2013
EFQM Enablers
• there are five Enablers, pictured on the left-hand side of the Model.
• these are the things an organisation needs to do to develop and implement its
strategy.
• Leadership - excellent organisations have leaders who shape the future and make it
happen, acting as role models for its values and ethics and inspiring trust at all times.
They are flexible, enabling the organisation to anticipate and reach in a timely manner
to ensure the on-going success of the organisation
• Strategy – they implement their Mission and Vision by developing a stakeholder
focused strategy. Policies, plans, objectives and processes are developed and
deployed to deliver the strategy
• People – organizations value their people and create a culture that allows the mutually
beneficial achievement of organisational and personal goals. They develop the
capabilities of their people and promote fairness and equality. They care for,
communicate, reward and recognise, in a way that motivates people, builds
commitment and enables them to use their skills and knowledge for the benefit of the
organisation
• Partnerships & Resources - organisations plan and manage external partnerships,
suppliers and internal resources in order to support their strategy, policies and the
effective operation of processes. They ensure that they effectively manage their
environmental and societal impact
• Processes, Products & Services - organisations design, manage and improve
processes, products and services to generate increasing value for customers and
other stakeholders
University of Zagreb, Faculty of Electrical Engineering and Computing, Department
of Fundamentals of Electrical Engineering and Measurements, 2013
EFQM Results
• four Results areas, shown on the right-hand side of the Model
are the results an organisation achieves, in line with their
strategic goals:
• Customer Results - achieve and sustain outstanding results that
meet or exceed the need and expectations of their customers
• People Results - achieve and sustain outstanding results that meet
or exceed the need and expectations of their people
• Society Results - achieve and sustain outstanding results that
meet or exceed the need and expectations of relevant
stakeholders within society
• Business Results - achieve and sustain outstanding results that
meet or exceed the need and expectations of their business
stakeholders
University of Zagreb, Faculty of Electrical Engineering and Computing, Department
of Fundamentals of Electrical Engineering and Measurements, 2013
EFQM Excellence Award
• EFQM Excellence Award was created by the organisation EFQM
• the prize recognises companies with excellent and sustainable results
across all areas of the EFQM Excellence Model.
• the assessment process is one of the most robust of any award, with a team
of independent assessors spending an average of 500 hours per applicant
reviewing documentation and conducting interviews on-site
• open to organisations from both the Private and Public Sectors
• 4 categories:
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1. Large Private Sector (over 1000 employees)
2. Small / Medium Private Sector (less than 1000 employees)
3. Large Public Sector (over 1000 employees)
4. Small / Medium Public Sector (less than 1000 employees)
• applicants will either be recognised as Finalists, Prize Winners or Award
Winners
• Award Winner is an organisation that is able to demonstrate that they are
considered a role model for the Fundamental Concepts of Excellence, as
defined in the EFQM Excellence Model
University of Zagreb, Faculty of Electrical Engineering and Computing, Department
of Fundamentals of Electrical Engineering and Measurements, 2013
EFQM More Info
• more info at http://www.efqm.org/
University of Zagreb, Faculty of Electrical Engineering and Computing, Department
of Fundamentals of Electrical Engineering and Measurements, 2013
References
• http://en.wikipedia.org/wiki/Six_Sigma
• Six Sigma Belts, http://howardgitlow.com/sixsigmabelts.htm
• Six Sigma DMAIC Roadmap, http://www.isixsigma.com/new-tosix-sigma/dmaic/six-sigma-dmaic-roadmap/
• DMAIC Versus DMADV, http://www.isixsigma.com/new-to-sixsigma/design-for-six-sigma-dfss/dmaic-versus-dmadv/
• Six Sigma Software, http://www.isixsigma.com/six-sigmasoftware/
• MBNQA at NIST, http://www.nist.gov/baldrige/, 2013.
• EFQM, http://www.efqm.org/, 2013.
University of Zagreb, Faculty of Electrical Engineering and Computing, Department
of Fundamentals of Electrical Engineering and Measurements, 2013