1. PREPARED BY : SALINAH BINTI SALLEH (817478) SITI NOOR BINTI ADNAN (817481) NURSUHANA BINTI MOHD AZMI (814165) AZAHARI BIN SALIM (817805) MOHD SHAMSUL BIN ISMAIL (817301) CHAPTER 10 : MANAGING QUALITY AND SIX SIGMA

4. W. Edwards Deming Higher quality leads to higher productivity and lower costs. Deming’s “Chain Reaction” theory “14 Points” management philosophy. Deming Cycle – Plan, Do, Study, and Act. Bringing about improvements in product and service quality by reducing uncertainty and variability in goods and services design and associated processes (the beginning of his ideas in 1920s and 1930s).

5. Joseph Juran Wrote Quality Control Handbook in 1951, a comprehensive quality manual. Defined quality as “fitness for use.” Advocated use of quality cost measurement. Quality Trilogy: quality planning, quality control, and quality improvement.

6. Philip B. Crosby Wrote Quality is Free in 1979, which brought quality to the attention of top corporate managers. Quality means conformance to requirements, not elegance. There is no such thing as the economics of quality; doing the job right the first time is always cheaper. The only performance measurement is the cost of quality which is the expense of nonconformance. The only performance standard is Zero Defects (ZD).

7. Philip B. Crosby Wrote Quality is Free in 1979, which brought quality to the attention of top corporate managers. Quality means conformance to requirements, not elegance. There is no such thing as the economics of quality; doing the job right the first time is always cheaper. The only performance measurement is the cost of quality which is the expense of nonconformance. The only performance standard is Zero Defects (ZD).

8. ISO9000:2000

10.  ISO 9000, was created by the International Organization for Standardization.  It specifies requirements for a quality management system in order to demonstrate that the facility can “provide products that consistently meet customer and applicable regulatory requirements” (ISO, 2002).  Certification requires an audit by an accredited third party. These audits must be renewed every three years.

11. The three basic standards in the ISO 9000:2000 family are: ISO 9000:2000, Quality Management Systems--Fundamentals and Vocabulary. ISO 9001:2000, Quality Management Systems--Requirements. ISO 9004:2000, Quality Management Systems--Guidelines for Performance Improvement.

12. Goals for the New Revisions  Meet stakeholder needs.  Be usable by all sizes of organizations.  Be usable by all sectors.  Be simple and clearly understood.  Connect quality management system to business processes. The Eight Quality Management Principles o Customer-focused organization. o Leadership. o Involvement of people. o Process approach. o System approach to management. o Continual improvement. o Factual approach to decision making. o Mutually beneficial supplier relationship.

15.  Basic elements of QMS ISO 9000 standards.  Contract management, design control and purchasing.  Process control ensure that a process performs as it should and take corrective action when it does not.  Corrective action and continual improvement. Designing Quality Management and Control Systems

16. Controlling Inspection, Measuring & Test Equipment. Metrology - the collection of people, equipment, facilities, methods, and procedures used to assure the correctness or adequacy of measurements. Designing Quality Management and Control Systems

17. Repeatability @ Equipment Variation the variation in multiple measurements by an individual using the same instrument. Reproducibility @ Operator Variation the variation in the same measuring instrument when it is used by different individuals to measure the same parts. Designing Quality Management and Control Systems

18. Records, Documentation & Audits  All the elements required for a quality system to achieve the required quality of conformance.  should be documented in a quality manual. Designing Quality Management and Control Systems

19. Designing Quality Management Systems

20. INTRODUCTION Most organizations use quality tools for controlling and assuring quality. There are Seven common Quality Tools we can use to understand and improve processes during a process improvement event. Each tool helps to identify sources of variation and aids in the analysis, documentation, and organization of the information, which leads to process improvement. What are those Seven Quality Tools?

21. THE TOOLS 1. Flowcharts or Process Maps 2. Ishikawa, Fishbone, or Cause & Effect Diagrams 3. Data Checklists or Check Sheets 4. Pareto Charts 5. Histograms Charts 6. Scatter Charts 7. Control Charts

22. 1. Flowcharts or Process Maps The tool maps out a sequence of events that take place sequentially or in parallel. Can be used to understand a process in order to find the relationships and dependencies between events. At high levels, process maps help you understand process complexity. At lower levels, is the quality tools helps you analyze and improve the process.

23. 2. Ishikawa, Fishbone, or Cause & Effect Diagrams Ishikawa, Fishbone, or Cause & Effect Diagrams visually represent the causes of a problem – or effect – and help you determine the ultimate source of the problem — the root cause. (This tool is called a “fishbone” diagram because of its appearance; Ishikawa was its inventor.)Cause & Effect Diagrams The cause-and-effect diagram is used at the beginning of root cause analysis, to organize the causes of a problem (people, methods, equipment, materials, measurement, and environment) and prioritize them.root cause analysis

24. 3. Data Checklists or Check Sheets A check sheet can be introduced as the most basic tool for quality. A check sheet is basically used for gathering and organizing data. Data Checklists, check sheets, or recording tables are matrices designed to assist in the tallying, recording, and analysis of test results or event occurrences.matrices This one of the quality tools are utilized in production to count defects and collect process data, which you analyze to identify opportunities for improvement.

25. 4. Pareto Charts Pareto charts are used for identifying a set of priorities. We can chart any number of issues/variables related to a specific concern and record the number of occurrences. This way we can figure out the parameters that have the highest impact on the specific concern. This helps us to work in order to get the condition under control.

26. 5. Histograms Charts HistogramsHistograms Charts consist of vertical bars, side-by-side, that depict frequency distributions within tables of numbers and can help us understand data relationships over time (e.g., the familiar “bell curve”).barstables Histograms are generally used during process improvement analysis.

27. 6. Scatter Charts Scatter chartsScatter charts is another of the quality tools. These display relationships between dependent (predicted) and independent (prediction) variables. They are used during hypothesis testing, to determine if there is a correlation between two variables and how strong the correlation is. Less scattering indicates stronger correlation.

28. 7. Control Charts Control chart is the best tool for monitoring the performance of a process. These types of charts can be used for monitoring any processes related to function of the organization. These charts allow you to identify the following conditions related to the process that has been monitored. 1. Stability of the process 2. Predictability of the process 3. Identification of common cause of variation 4. Special conditions where the monitoring party needs to react

29. CONCLUSION Above seven basic quality tools help you to address different concerns in an organization. Therefore, use of such tools should be a basic practice in the organization in order to enhance the efficiency. Trainings on these tools should be included in the organizational orientation program, so all the staff members get to learn these basic tools.

30. Six Sigma (6 σ)

31. Definition of Six Sigma (6 σ) Six Sigma is a set of techniques and tools for process improvement. It was developed by Motorola in 1986. By the late 1990’s, about 2/3 of the Fortune 500 organizations had begun Six Sigma initiatives with the aim of reducing costs and improving quality. Six Sigma seeks to improve the quality of process outputs by identifying and removing the causes of defects (errors) and minimizing variability in manufacturing and business processes. Used by companies including Motorola, Allied Signal, Texas Instruments, and General Electric.

32. Method of Six Sigma (6 σ) It uses a set of quality management methods, including statistical methods, and creates a special infrastructure of people within the organization (E.g: Champions, Black Belts, Green Belts, Yellow Belts, etc who are experts in this methods). The term Six Sigma originated from terminology associated with statistical modeling of manufacturing processes. The maturity of a manufacturing process can be described by a sigma rating indicating its yields or the % of defect-free products it creates.

33. Method of Six Sigma (6 σ) A Six Sigma process: a) 99.99966% of the products manufactured are statistically expected to be free defects; and b) 3.4 defective parts/million Defects are any mistakes or errors that are passed on to the customer. Defects per Unit (DPU)=Number of Defects Discovered Number of Units Processed

34. Doctrine of Six Sigma (6 σ) To reduce process variation are of vital importance to business success. Manufacturing and business processes have characteristics that can be measured, analyzed, controlled and improved. Features that set Six Sigma apart from previous quality improvement initiatives include: i) a clear focus on achieving measurable and quantifiable financial returns from any Six Sigma project ii) an increased emphasis on strong and passionate management leadership and support iii) a clear commitment to making decisions on the basis of verifiable data and statistical methods, rather than assumptions and guesswork.

35. Methodologies of Six Sigma (6 σ) Six Sigma projects follow 2 project methodologies inspired by Deming’s Plan-Do-Check-Act Cycle. DMAIC is used for projects aimed at improving and existing business process. The DMAIC project methodology has 5 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. 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, future state process and mistake proofing. ► Control the future state process to ensure that any deviations from the target are corrected before they result in defects.

36. Methodologies of Six Sigma (6 σ) DMADV is used for projects aimed at creating new product or process designs. The DMADV project methodology has 5 phases: ► Define design goals that are consistent with customer demands and the enterprise strategy. ► Measure and identify CTQs (Critical To Quality), product capability and risks. ► Analyze to develop and design alternatives. ► Design or and 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).

37. Etymology of Six Sigma Process The term "six sigma process" comes from the notion that 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. This is based on the calculation method employed in process capability studies. Capability studies measure the number of standard deviations between the process mean and the nearest specification limit in sigma units, represented by the Greek letter σ (sigma). As process standard deviation goes up, or the mean of the process moves away from the center of the tolerance, fewer standard deviations will fit between the mean and the nearest specification limit, decreasing the sigma number and increasing the likelihood of items outside specification. One should also note that calculation of Sigma levels for a process data is independent of the data being normally distributed. In one of the criticisms to Six Sigma, practitioners using this approach spend a lot of time transforming data from non- normal to normal using transformation techniques. It must be said that Sigma levels can be determined for process data that has evidence of non-normality.

38. Sigma Level The table above gives long-term DPMO values corresponding to various short-term sigma levels.DPMO It must be understood that these figures assume that the process mean will shift by 1.5 sigma toward the side with the critical specification limit. In other words, they assume that after the initial study determining the short-term sigma level, the long-term C pk value will turn out to be 0.5 less than the short-term C pk value.C pk value So, for example, the DPMO figure given for 1 sigma assumes that the long-term process mean will be 0.5 sigma beyond the specification limit (C pk = –0.17), rather than 1 sigma within it, as it was in the short-term study (C pk = 0.33).DPMO Note that the defect percentages indicate only defects exceeding the specification limit to which the process mean is nearest. Defects beyond the far specification limit are not included in the percentages.

39. Sigma Level A control chart depicting a process that experienced a 1.5 sigma drift in the process mean toward the upper specification limit starting at midnight. Control charts are used to maintain 6 sigma quality by signaling when quality professionals should investigate a process to find and eliminate special-cause variation.control chartspecial-cause variation