MEE254 Statistical Quality Control FALL 2015-16

MEE254 Statistical Quality Control

B. Tech. - Production and Industrial Engineering | Fall 2015 | G1
Unit 5 – Introduction to ISO and Six Sigma

Dr. Jeevanantham, A.K. M.E., Ph.D.,

Professor | Manufacturing Division,
School of Mechanical and Building Sciences,
VIT University | Vellore – 632 014.

akjeevanantham@yahoo.com / akjeevanantham@vit.ac.in

International Standard Organization

» ISO-9000 series and ISO-14000 environmental series
↣ Origins: Military requirements

↯ for example, NATO (1940s) developed specifications and methods of

production to ensure compatibility between NATO forces in weapons and
weapons systems

↯ In Britain ISO 9000’s predecessor was the British standard BS 5750, which
was introduced in 1979 to set standard specifications for military suppliers.

Dr.Jeevanantham,A.K.
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Professor, SMBS, VIT University-Vellore

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International Standard Organization

» ISO 9000 certification means
↣ an organization constantly meets rigorous standards (which are well
documented) of management of quality of product and services.

↣ To retain certification the organization is audited annually by an outside

accredited body.

↣ ISO 9000 on the letterhead of an organization demonstrates to its

employees, to its customers and to other interested bodies that it has an
effective quality assurance system in place.

Dr.Jeevanantham,A.K.
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Professor, SMBS, VIT University-Vellore

International Standard Organization

» ISO 9000 series
↣ to give customers confidence that the product or service being provided
will meet certain specified standards of performance, and that the product
or service will always be consistent with those standards

↣ ISO system will show an organization how to go about establishing and

documenting a quality improvement system

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Professor, SMBS, VIT University-Vellore

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International Standard Organization

» several standards in ISO 9000 series
↯ 9000,

↯ 9001,

↯ 9002,

↯ 9003,

↯ 9004, and

↯ since 1996, the ISO 14000 series

Dr.Jeevanantham,A.K.
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Professor, SMBS, VIT University-Vellore

International Standard Organization

» several standards in ISO 9000 series
↣ ISO 9000

↯ Deals with how to choose other ISO series standards for inclusion in a
contract between a customer and a supplier

↯ Reference is made to documentation

↣ ISO 9001

↯ Should be chosen if there is design work or changes to designs involved,

and/or if after-sales service is required.

↣ ISO 9002

↯ Should be chosen if there is no design work involved and/or no after-sales

service in the contract.

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Professor, SMBS, VIT University-Vellore

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MEE254 Statistical Quality Control FALL 2015-16

International Standard Organization

» several standards in ISO 9000 series
↣ ISO 9003

↯ To include corrective action taken during the process. only requires one final
check, and thus is not a good way of reducing costs of mistakes and of
instilling a quality culture into the organization.

↯ If such amendments are made, then ISO 9002 may be more appropriate.

↣ ISO 9004

↯ Extensively uses the word ‘should’. This means that an organization is not
required actually to do anything included in the standard, and thus ISO 9004
can only be regarded as an advisory introduction paper to quality
management.

Dr.Jeevanantham,A.K.
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Professor, SMBS, VIT University-Vellore

International Standard Organization

» several standards in ISO 9000 series
↣ ISO 14000

↯ Concerns environmental (green) issues.

↯ Achievement of the standards is said to lead to business benefit through

process performance improvement, cost reduction, reduced pollution,
legislative compliance, and an improved public image.

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Professor, SMBS, VIT University-Vellore

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International Standard Organization

» ISO 9000 series - Quality Management Standards (QMSs)
↣ ISO 9000

↯ Quality Management Systems: Fundamentals and Vocabulary

↣ ISO 9001

↯ Quality Management Systems: Requirements

↣ ISO 9004

↯ Quality Management Systems: Guidelines for Performance Improvements

↣ As per The American National Standards Institute and the American

Society for Quality

↯ ANSI/ISO/ASQ Q9000, Q9001, and Q9004, respectively

Dr.Jeevanantham,A.K.
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Professor, SMBS, VIT University-Vellore

International Standard Organization

» The ISO 9001:2000 standard has eight clauses
1. Scope,

2. Normative References,

3. Definitions,

4. Quality Management Systems,

5. Management Responsibility,

6. Resource Management,

7. Product (or Service) Realization, and

8. Measurement, Analysis, and Improvement.

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Professor, SMBS, VIT University-Vellore

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International Standard Organization

» ISO 9001:2000 Requirements
↣ 4.0 Quality Management System

↯ 4.1 General Requirements

– The organization shall establish, document, implement, and maintain a

quality management system and continually

– improve its effectiveness in accordance with the requirements of the

international standard.

↯ 4.2 Documentation Requirements

– Quality management system documentation will include a quality policy

and quality objectives; a quality manual;

– documented procedures; documents to ensure effective planning,

operation, and control of processes; and records

– required by the international standard.

Dr.Jeevanantham,A.K.
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Professor, SMBS, VIT University-Vellore

International Standard Organization

» ISO 9001:2000 Requirements
↣ 5.0 Management System

↯ 5.1 Management Commitment

a) Communication of meeting customer, statutory, and regulatory

requirements

b) Establishing a quality policy

c) Establishing quality objectives

d) Conducting management reviews

e) Ensuring that resources are available

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Professor, SMBS, VIT University-Vellore

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International Standard Organization

» ISO 9001:2000 Requirements
↣ 5.0 Management System

↯ 5.2 Top management shall ensure that customer requirements are

determined and are met with the aim of enhancing customer
satisfaction.

↯ 5.3 Management shall establish a quality policy.

↯ 5.4 Management shall ensure that quality objectives shall be established.

Management shall ensure that planning occurs for the quality
management system.

↯ 5.5 Management shall ensure that responsibilities and authorities are

defined and communicated.

↯ 5.6 Management shall review the quality management system at regular

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intervals. Professor, SMBS, VIT University-Vellore
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International Standard Organization

» ISO 9001:2000 Requirements
↣ 6.0 Resource Management

↯ 6.1 The organization shall determine and provide needed resources.

↯ 6.2 Workers will be provided necessary education, training, skills, and

experience.

↯ 6.3 The organization shall determine, provide, and maintain the

infrastructure needed to achieve conformity to product requirements.

↯ 6.4 The organization shall determine and manage the work environment
needed to achieve conformity to product requirements.

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Professor, SMBS, VIT University-Vellore

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International Standard Organization

» ISO 9001:2000 Requirements
↣ 7.0 Product or Service Realization
↯ 7.1 The organization shall plan and develop processes needed for product
or service realization.
↯ 7.2 The organization shall determine requirements as specified by
customers.
↯ 7.3 The organization shall plan and control the design and development
for its products or services.
↯ 7.4 The organization shall ensure that purchased material or product
conforms to specified purchase requirements.
↯ 7.5 The organization shall plan and carry out production and service
under controlled conditions.
↯ 7.6 The organization shall determine the monitoring and measurements
to be undertaken and the monitoring and measuring devices needed
to provide evidence of conformity of products or services to
Dr.Jeevanantham,A.K.
determined requirements.
Professor, SMBS, VIT University-Vellore
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International Standard Organization

» ISO 9001:2000 Requirements
↣ 8.0 Measurement, Analysis, and Improvement

↯ 8.1 The organization shall plan and implement the monitoring,

measurement, analysis, and improvement process for continual
improvement and conformity to requirements.

↯ 8.2 The organization shall monitor information relating to customer

perceptions.

↯ 8.3 The organization shall ensure that product that does not conform to
requirements is identified and controlled to prevent its unintended
use or delivery.

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Professor, SMBS, VIT University-Vellore

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International Standard Organization

» ISO 9001:2000 Requirements
↣ 8.0 Measurement, Analysis, and Improvement

↯ 8.4 The organization shall determine, collect, and analyze data to

demonstrate the suitability and effectiveness of the quality
management system, including
a) a. Customer satisfaction
b) b. Conformance data
c) c. Trend data
d) d. Supplier data

↯ 8.5 The organization shall continually improve the effectiveness of the

quality management system.

Dr.Jeevanantham,A.K.
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Professor, SMBS, VIT University-Vellore

Six-sigma

» Sigma (σ)
↣ Standard deviation

↣ Measures how much variation exists in a distribution of data

↣ A key factor in determining the acceptable number of defective units found

in a population

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Professor, SMBS, VIT University-Vellore

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Six-sigma

» Sigma (σ)
↣ Standard deviation

↣ Measures how much variation exists in a distribution of data

↣ A key factor in determining the acceptable number of defective units found

in a population

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Professor, SMBS, VIT University-Vellore

Six-sigma

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Professor, SMBS, VIT University-Vellore

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Six-sigma

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Professor, SMBS, VIT University-Vellore

Six-sigma

» People power: Executive Leader

Champions & Sponsors

Master Black Belt

Black Belt

Green Belt Green Belt Green Belt

Team Team Team Team

Team Team Team

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Professor, SMBS, VIT University-Vellore

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MEE254 Statistical Quality Control FALL 2015-16

Six-sigma

» Process Power: DMAIC approach

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Professor, SMBS, VIT University-Vellore

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