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

2. Dr. Joseph Greene Copyright 2000 All Rights Reserved 2 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

3. Dr. Joseph Greene Copyright 2000 All Rights Reserved 3 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).

4. Dr. Joseph Greene Copyright 2000 All Rights Reserved 4 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.

5. Dr. Joseph Greene Copyright 2000 All Rights Reserved 5 ISO 9000 Requires Documentation RECORDS REQUIRED BY ISO 9001:2000

6. Dr. Joseph Greene Copyright 2000 All Rights Reserved 6 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

7. Dr. Joseph Greene Copyright 2000 All Rights Reserved 7 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.

8. Dr. Joseph Greene Copyright 2000 All Rights Reserved 8 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.

9. Dr. Joseph Greene Copyright 2000 All Rights Reserved 9 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.

10. Dr. Joseph Greene Copyright 2000 All Rights Reserved 10 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,

11. Dr. Joseph Greene Copyright 2000 All Rights Reserved 11 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

12. Dr. Joseph Greene Copyright 2000 All Rights Reserved 12 ISO 9004 Principle 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).

13. Dr. Joseph Greene Copyright 2000 All Rights Reserved 13 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.

14. Dr. Joseph Greene Copyright 2000 All Rights Reserved 14 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.

15. Dr. Joseph Greene Copyright 2000 All Rights Reserved 15 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.