Quality Engineering 品管 / 品保 Instructor: Jennifer H. Hsiang

 Definition  History  Q.C. + Q.A.  Organization Chart  Failure Testing  A.Q.L.  T.Q.M.  ISO 9000  Six Sigma Quality Engineering

Definition  QC = Quality Control 品管  QA = Quality Assurance 品保

Definition  In engineering and manufacturing, quality control and quality engineering are involved in developing systems to ensure products or services are designed and produced to meet or exceed customer requirements.

History  During the Middle Ages, guilds ( 中世紀 的行會 ) took the responsibility of quality control upon themselves.  All practitioners of a particular trade living in a certain area were required to join the corresponding guild, and the guild instituted punishments for members who turned out shoddy products..

History  Prior to the Industrial, it was possible for a workman to control the quality of his own product. Working conditions then were more conducive to professional pride.  The Industrial Revolution led to a system in which large groups of men performing a similar type of work were grouped together under the supervision of a foreman who also took on the responsibility to control the quality of work manufactured.

History  Quality Assurance has developed a good deal during the last years (in about 20 year intervals) from its inception to the current state of the art.

Q.C. + Q.A.  During World War I, the manufacturing process became more complex, and the introduction of large numbers of workers being supervised by a foreman designated to ensure the quality of the work, which was being produced.

Q.C. + Q.A.  The systematic approach to quality started in industrial manufacture during the 1930’s, mostly in the USA.  With the impact of mass production, which was required during the Second World War, it became necessary to introduce a more stringent ( 嚴厲的 ) form of quality control which can be identified as Statistical Quality Control, or SQC.

Q.C. + Q.A.  After World War II, the United States continued to apply the concepts of inspection and sampling to remove defective product from production lines.  After World War II, the U.S. sent General Douglas MacArthur to oversee the re- building of Japan.

Q.C. + Q.A.  During this time, General MacArthur invited two key individuals in the development of modern quality concepts: W. Edwards Deming and Joseph Juran.  Both individuals promoted the collaborative concepts of quality to Japanese business and technical groups, and these groups utilized these concepts in the redevelopment of the Japanese economy.

Q.C. + Q.A.  Definition Quality Assurance covers all activities from design, development, production, installation, servicing and documentation, this introduced the rules: "fit for purpose" and "do it right the first time". It includes the regulation of the quality of raw materials, assemblies, products and components; services related to production; and management, production, and inspection processes.

Organization Chart V.P. Engineering QA Inspection IQC Inspection IPQC Inspection FQC Engineering Manager QA Manager IQC Staff IPQC Staff FQC Staff

Failure Testing  A valuable process to perform on a whole consumer product is failure testing, the operation of a product until it fails, often under stresses such as increasing vibration, temperature and humidity.  This exposes many unanticipated weakness in a product, and the data is used to drive engineering and manufacturing process improvement.

A.Q.L.  Traditional statistical process controls in manufacturing operations usually proceed by randomly sampling and testing a fraction of the output.  Variances of critical tolerances are continuously tracked, and manufacturing processes are corrected before bad parts can be produced.

A.Q.L.  A.Q.L. stands for Acceptable Quality Level / Limit  For over 3 decades Quality Inspector's have to been using the AQL Inspector's Rule to ease their job.  This easy to use slide Rule simplifies and streamlines the process of looking up Accept and Reject numbers for inspection using the MIL-STD-105E.

A.Q.L.  A list of industries that use AQL to ease their quality control inspection. Pharmaceuticals Food Services Processed food companies Textiles and Apparel manufactures Medical Devices Large Software and Telephone Companies Industrial Controls Components Printing QC consulting firms

A.Q.L.  A.Q.L. Sampling Plan Table (see teacher’s handout) - Inspection levels I, II, III, & S-1 to S-4 - Single sampling plan

A.Q.L.

During the 1980’s, the concept of “company quality” with the focus on management and people came to the T.Q.M = Total Quality It was realized that, if all departments approached quality with an open mind, success was possible if the management led the quality improvement process.

The company-wide quality approach places an emphasis on three aspects : 1. Elements ( 元素 ) such as controls, job management, adequate processes, performance and integrity criteria and identification of records 2. Competence ( 資格 ) such as knowledge, skills, experience, qualifications 3. Soft elements ( 人為 ) such as personnel integrity, confidence, organizational culture, motivation, team spirit and quality relationships.

The approach to quality management given here is therefore not limited to the manufacturing theatre only but can be applied to any business activity: - Design work - Administrative services - Consulting - Banking - Insurance - Computer software - Retailing - Transportation...

This in turn is supported by quality management practices which can include a number of business In manufacturing activities, these business practices can be equated to the models for quality assurance defined by the International Standards contained in the ISO 9000 series

A few refinements has to be introduced: 1. Marketing had to carry out their work properly and define the customer’s specifications. 2. Specifications had to be defined to conform to these requirements. 3. Conformance to specifications i.e. drawings, standards and other relevant documents, were introduced during manufacturing, planning and control.

A few refinements has to be introduced: 4. Management had to confirm all operators are equal to the work imposed on them and holidays, celebrations and disputes did not affect any of the quality levels. 5. Inspections and tests were carried out, and all components and materials, bought in or otherwise, conformed to the specifications, and the measuring equipment was accurate, this is the responsibility of the QA/QC department. 6. Any complaints received from the customers were carefully and satisfactorily dealt with. 7. Feedback from the user/customer is used to review designs.

ISO 9000 r ISO 9000 is a family of standards for quality management systems. rISO 9000 is maintained by ISO, the International Organizational for Standardization and is administered by accreditation and certification bodies.

ISO 9001 rISO 9001 is one of the standards in the ISO 9000 family, it includes: - A set of procedures that cover all key processes in the business - Monitoring manufacturing processes to ensure they are producing quality product. - keeping proper records. - checking outgoing product for defects, with appropriate corrective action where necessary. - regularly reviewing individual processes and the quality system itself for effectiveness.

ISO 9001 r A company or organization that has been independently audited and certified to be in conformance with ISO 9001 may publicly state that it is "ISO 9001 certified" or "ISO 9001 registered."

ISO rThe ISO environmental management standards exist to help organizations minimize how their operations negatively affect the environment (cause adverse changes to air, water, or land), comply with applicable laws, regulations, and other environmentally oriented requirements, and continually improve on the above. rISO is similar to ISO 9000 quality management in that both pertain to the process (how a product is produced) rather than to the product itself.

Six-Sigma r Many organizations use statistical process control to bring the organization to Six Sigma levels of quality, in other words, so that the likelihood of an unexpected failure is confined to six standard deviations on the normal distribution. r This probability is less than four one- millionths. Items controlled often include clerical tasks such as order-entry as well as conventional manufacturing tasks.

Six-Sigma ס Definition - What Is Six Sigma ? : Six Sigma stands for Six Standard Deviations (Sigma is the Greek letter used to represent standard deviation in statistics) from mean. Six Sigma methodology provides the techniques and tools to improve the capability and reduce the defects in any process.

Six-Sigma סIt was started in Motorola, in its manufacturing division, where millions of parts are made using the same process repeatedly. סEventually Six Sigma evolved and applied to other non manufacturing processes. Today you can apply Six Sigma to many fields such as Services, Medical and Insurance Procedures, Call Centers.

Six-Sigma ס Six Sigma methodology improves any existing business process by constantly reviewing the process. ס To achieve this, Six Sigma uses a methodology known as DMAIC (Define Opportunities, Measure performance, Analyze opportunity, Improve performance, Control performance).

Six-Sigma סSix Sigma methodology can also be used to create a brand new business process from ground up using DFSS (Design For Six Sigma) principles. סSix Sigma Strives for perfection. It allows for only 3.4 defects per million opportunities for each product or service transaction. Six Sigma relies heavily on statistical techniques to reduce defects and measure quality.

Six-Sigma ס Six Sigma experts (Green Belts and Black Belts) evaluate a business process and determine ways to improve upon the existing process. סSix Sigma experts can also design a brand new business process using DFSS (Design For Six Sigma) principles. Typically its easier to define a new process with DFSS principles than refining an existing process to reduce the defects.

Six-Sigma Six Sigma Six Sigma incorporates the basic principles and techniques used in Business, Statistics, and Engineering. These three form the core elements of Six Sigma. Six Sigma improves the process performance, decreases variation and maintains consistent quality of the process output. This leads to defect reduction and improvement in profits, product quality and customer satisfaction.

Six-Sigma Six Sigma methodology is also used in many Business Process Management initiatives these days. These Business Process Management initiatives are not necessarily related to manufacturing. Many of the BPM's that use Six Sigma in today's world include call centers, customer support, supply chain management and project management.

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