Dr. Joseph Greene Copyright 2000 All Rights Reserved 1 ISO 9000, Six Sigma and Other Quality Mysteries

Dr. Joseph Greene Copyright 2000 All Rights Reserved

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ISO 9000, Six Sigma and Other Quality Mysteries


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Introduction• Times are changing for quality– In the 1970’s, almost anything manufactured was accepted and

shipped.• Quality was measured but not well controlled.• Quality problems were passed on to customers.• Designs didn’t change too quickly.• Competition was regional with very little from international.• GM had over 50% of the market share of cars.

– In 1980’s worldwide competition forced higher quality.• Many improvements were needed to get higher quality at lowest cost.• Labor costs became large and quality per cost ratio

– In the 1990’s time to market became paramount.• Quality measurements influenced product manufacturing.• Downsizing, re-engineering, and people changes to meet growing expectations

of customers.• Highest quality at lowest cost.• Quality engineering involves the whole product process from cradle to grave or

design concept to manufacturing products to specifications


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Introduction• ISO Technical Committee was formed in 1979

– To harmonize the increasing international activity in quality management and quality assurance standards. Subcommittee was established to determine common terminology.

– It developed ISO 8402: Quality-Vocabulary, which was published in 1986. (ASQ published ANSI/ASQ A8402-1994: Quality Systems Terminology.

• While this document is not an adoption of ISO 8402, it does contain many of the exact terms and definitions contained in ISO 8402.)

• Subcommittee 2 was established to develop quality systems standards--the result being the ISO 9000 series, published in 1987 (revised 1994).


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ISO 9000• The ISO 9000 series is a set of five individual, but

related, international standards on quality management and quality assurance. – ISO 9000 requires documentation for everything in

manufacturing process.– They are generic, not specific to any particular products.– They can be used by manufacturing and service industries

alike. – These standards were developed to effectively document

the quality system elements to be implemented in order to maintain an efficient quality system in your company.

– The ISO 9000 Series standards do not themselves specify the technology to be used for implementing quality system elements.


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ISO 9000 Requires Documentation• RECORDS REQUIRED BY ISO 9001:2000

Clause Record required5.6.1 Management reviews6.2.2 (e) Education, training, skills and experience7.1 (d) Evidence that the realization processes and resulting product fulfill requirements7.2.2 Results of the review of requirements relating to the product and actions arising from the review7.3.2 Design and development inputs7.3.4 Results of design and development reviews and any necessary actions7.3.5 Results of design and development verification and any necessary actions7.3.6 Results of design and development validation and any necessary action7.3.7 Results of the review of design and development changes and any necessary actions7.4.1 Results of supplier evaluations and actions arising from the evaluations

7.5.2 (d) As required by the organization to demonstrate the validation of processes where the resulting output cannot be verified by subsequent monitoring or measurement

7.5.3 The unique identification of the product, where traceability is a requirement7.5.4 Customer property that is lost, damaged or otherwise found to be unsuitable foruse

7.6 (a) Standards used for calibration or verification of measuring equipment where no international or national measurement standards exist

7.6 Validity of previous results when measuring equipment is found not to conform with its requirements7.6 Results of calibration and verification of measuring equipment8.2.2 Internal audit results

8.2.4 Evidence of product conformity with the acceptance criteria and indication of the authority responsible for the release of the product

8.3Nature of the product nonconformities and any subsequent actions taken, including concessions obtained

8.5.2 Results of corrective action 8.5.3 Results of preventive action


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ISO 9000• There are several benefits to implementing this

series in your company. • For example, it will guide you to build quality into your

product or service and avoid costly after-the-fact inspections, warranty costs, and rework.

• In addition, you may also be able to reduce the number of audits customers perform on your operation.

• Increasingly, customers are accepting supplier quality system registration from an accredited third-party assessment based on these standards.

– References• J. Lahey and R. Launsby, Experimental Design for Injection Molding,

Launsby Publishing, Colorado Springs, CO(1998)

• http://www.asq.org


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ISO 9000• ISO 9000 provides the user with guidelines for selection

and use of ISO 9001, 9002, 9003 and 9004. • ISO 9001, 9002, and 9003 are quality system models for

external quality assurance. – These three models are actually successive subsets of each other. – ISO 9001 is the most comprehensive--covering design,

manufacturing, installation, and servicing systems. – ISO 9002 covers production and installation, and – ISO 9003 covers only final product inspection and test.

• These three models were developed for use in contractual situations such as those between a customer and a supplier.– ISO 9004 provides guidelines for internal use by a producer

developing its own quality system to meet business needs and take advantage of opportunities.


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ISO 9000• The choice of which model to implement depends

on the scope of your operation. – For example, if you design your own product or service,

you must consider ISO 9001. – If you only manufacture (working off someone else's

design) you may wish to consider ISO 9002. – Finally, if you neither design nor manufacture, you may

wish to consider ISO 9003.


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ISO 9000• Purpose of ISO is

• to promote the development of standardization and related world activities • to facilitate the international exchange of goods and services, and • to develop cooperation in intellectual, scientific, technological, and economic

activity.

• Introduced in 1987 and adopted in 96 countries.• American National Standard Institute (ANSI) is the member

body representing the US.– Standards are designed to be utilized by manufacturing, process, and

services• ISO 9000: A road map for use of other standards in this series• ISO 9001: A model for use when the company must design and produce a

product• ISO 9002: A model for use when a company produces a product• ISO 9003: A model for quality assurance in final inspection and testing• ISO 9004: Provides quality management and quality system guidelines for use

by a company in developing and implementing a quality system.


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ISO 9001• ISO 9001: A model for use when the company must

design and produce a product– Section 4.2.3: Quality Planning

– The supplier shall define and document the requirements for quality will be met. Quality planning shall be consistent with all other requirements of a supplier’s quality system and shall be documented in a format to suit the supplier’s methods of operation….

– The supplier shall give consideration to the following:

» the preparation of quality plans,

» the identification and acquisition of any controls, process, equipment (including inspection and test equipment) fictures, resources, and skills that may be needed to achieve the required quality,

» ensuring the compatibility of the design, the production process, installation, servicing, inspection and test procedures,


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ISO 9004• Reference: http://www.tc176.org/

– This document introduces the eight quality management principles on which the quality management system standards of the revised ISO 9000:2000 series are based.

– The principles are derived from the collective experience and knowledge of the international experts who participate in ISO Technical Committee ISO/TC 176, Quality management and quality assurance, which is responsible for developing and maintaining the ISO 9000 standards.

– The eight quality management principles are defined in ISO 9000:2000, Quality management systems – Fundamentals and vocabulary, and in ISO 9004:2000, Quality management systems – Guidelines for performance improvements.

• Principle 1 – Customer focus • Principle 2 – Leadership • Principle 3 – Involvement of people • Principle 4 – Process approach • Principle 5 – System approach to management • Principle 6 – Continual improvement • Principle 7 – Factual approach to decision making • Principle 8 – Mutually beneficial supplier relationships


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ISO 9004Principle 1 – Customer focus

– Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations.

– Key benefits: – Increased revenue and market share obtained through flexible and fast responses to

market opportunities. – Increased effectiveness in the use of the organization's resources to enhance

customer satisfaction. – Improved customer loyalty leading to repeat business. – Applying the principle of customer focus typically leads to:

• Researching and understanding customer needs and expectation• Ensuring that the objectives of the organization are linked to customer needs and

expectations. • Communicating customer needs and expectations throughout the organization.

• Measuring customer satisfaction and acting on the results. • Systematically managing customer relationships. • Ensuring a balanced approach between satisfying customers and other interested

parties (such as owners, employees, suppliers, financiers, local communities and society as a whole).


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QS 9000• QS-9000 is the shorthand name for "Quality System

Requirements QS-9000." – It is the common supplier quality standard for Chrysler

Corporation, Ford Motor Company, and General Motors Corporation.

– QS-9000 is based on the 1994 edition of ISO 9001, but it contains additional requirements that are particular to the automotive industry.

– These additions are considered automotive "interpretations" by the ISO community of accreditation bodies and registrars.

– QS-9000 applies to suppliers of production materials, production and service parts, heat treating, painting and plating and other finishing services.

– It does not, therefore, apply to all suppliers of the Big Three.


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Six Sigma• Ultimate goal is to ship product with zero defects to the customer.

– Six sigma recognizes that defects that are generated prior to shipping still represent lost time and materials.

– Six sigma helps stop variation in product quality at the earliest possible point.• The product and process design phase

• Sigma,, is statistical unit of measure which reflects your process capability. It is the square root of the variance and similar to the standard deviation.

• The variance is a measure of the spread of the data or how much variability exits.

• Minimum sigma is best.• Six sigma means achieving a desired value plus or minus 3 sigma.

– It represents 99.99966% of the data on a bell shaped curve.

• When six sigma quality is achieved, 99.99966% of the products and services are defect-free.


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Six Sigma• Six Sigma focuses on variations as the number one enemy

in the battle to obtain a high quality product at a low cost.• Primary sources of variation are

– Inadequate design margin

– Inadequate process control

– Unstable parts and material

• If manufacturers are to achieve six sigma quality, they must isolate, control, and continuously reduce variation.

• Experimentation is needed to reduce variation.– Can choose trial and error, or

– Design of experiments with full factorial or partial factorial designs

• Design of experiments (DOE) is the best way to control a process and reduce variation.– Taguchi DOE is very popular and very efficient experimentation method.

Documents

Dr. Joseph Greene Copyright 2000 All Rights Reserved 1 ISO 9000, Six Sigma and Other Quality Mysteries