Quality course on aircraft maintenance.pptx

Course on QC

1. INTRODUCTION Name: Sqn Ldr Farrukh Mazhar Course: 52 Engg Course QUALIFICATION MS (2007) (Aerospace Structures - Solid Mechanics) Air University BE (2000) (Aerospace Engineering) CAE WORKING EXPERIENCE Engineering Officer PAF Mushaf Instructor Dept of Industrial Engg CAE, 1 st tenure Instructor at Dept of Aerospace Engg, CAE 2 nd tenure

2. TOTAL QUALITY MANAGEMENT TOOLS AND TECHNIQUES SQN LDR FARRUKH MAZHAR DEPARTMENT OF AEROSPACE ENGINEERING COLLEGE OF AERONAUTICAL ENGINEERING

3. Outline Statistical Process Control Acceptance Sampling Reliability Design of Experiments (DOE) Taguchi’s Quality Engineering

4. Outline-Continued Management and Planning Tools Quality by Design Products Liability Information Technology Computer Program

5. Learning Objectives When you have completed this module you should be able to: Construct a Pareto diagram Explain how to construct a cause and effect diagram Explain how to construct a check sheet Know the major sections of ISO 9000 and briefly describe their emphasis

6. Learning Objectives- Continued Know the objectives, techniques, procedures, and benefits of an internal audit List the quantitative and qualitative TQM tools and techniques

7. TOTAL QUALITY MANAGEMENT Total Quality Management (TQM) is an enhancement to the traditional way of doing business It is a proven technique to guarantee survival in world-class competition Only by changing actions of management the culture and actions of an entire organization will be transformed As the name suggests, TQM is the art of managing the whole to achieve excellence

8. TOTAL QUALITY MANAGEMENT TQM is defined as both a philosophy and a set of guiding principles that represent the foundation of a continuously improving organization It is the application of quantitative methods and human resources to improve all the processes within an organization and exceed customer needs now and in the future TQM integrates fundamental management techniques, existing improvement efforts, and technical tools under a disciplined approach

9. SCOPE OF TQM

10. PRINCIPALS AND PRACTICES

11. TOOLS AND TECHNIQUES

12. QUANTITATIVE

13. NON-QUANTITATIVE

14. STATISTICAL PROCESS CONTROL (SPC) Control Charts

15. PARETO DIAGRAM Alferdo Pareto (1848 – 1923) Dr Joseph Juran applied this theory to many fields Vital Few and Useful Many

16. PARETO DIAGRAM A Pareto Diagram is a graph that ranks data classification in descending order from left to right Types of Field Failures Frequency Vital Few Useful Many Categorical

17. PARETO DIAGRAM Frequency Percent The cumulative percentage scale, when used, must match with the dollar or frequency scale such that 100% is at the same height as the total dollars or frequency

18. PARETO DIAGRAM Pareto Diagrams are used to identify the most important problems Usually , 80% of the total results from 20% of the items In the graphs shown earlier, the F and C types of field failures account for almost 80% of the total Actually the most important items could be identified by listing the items in descending order However, the graph has the advantage of providing a visual impact of those vital few characteristics that need attention

19. PARETO DIAGRAM Resources are then directed to take necessary action Examples of vital few could be: A few customers account for the majority of sales A few product, processes, or quality characteristics account for the bulk of scrap or rework cost A few nonconformities account for the majority of customer complaints A few vendors account for the majority of rejected parts A few problems account for the bulk of the process downtime A few products account for the majority of the project A few items account for the bulk of the inventory cost

20. STEPS TO DRAW PARETO DIAGRAM Determine the method of classifying the data: by problem, cause, type of nonconformities, and so forth Decide if dollars, weighted frequency, or frequency is to be used to rank the characteristics Collect data for an appropriate time interval Summarize the data and rank order categories from the largest to smallest Compute the cumulative percentage if it is to be used Construct the diagram and find the vital few

21. ANALYSIS OF PARETO DIAGRAM It is noted that a quality improvement of the vital few, of say 50%, is a much greater return on investment than a 50% improvement of the useful many Experience has shown that it is easier to make a 50 % improvement in the vital few The use of Pareto Diagram is a never ending process For example lets assume that F is the target for correction in the improvement programme A project team has assigned to investigate and make improvement The next time Pareto analysis is made, another field failure say C, becomes the target of correction and the improvement process continues until field failures become an insignificant quality programme

22. Example

23. Example

24. Example

25. CONCLUSION The Pareto diagram is a powerful quality improvement tool It is applicable to problem identification and the measurement of progress

26. CAUSE AND EFFECT DIAGRAM A graphic tool that helps identify, sort, and display possible causes of a problem or quality characteristic

27. CAUSE AND EFFECT DIAGRAM Helps determine root causes Encourages group participation Uses an orderly, easy-to-read format Indicates possible causes of variation Increases process knowledge Identifies areas for collecting data

28. CAUSE AND EFFECT DIAGRAM A cause and effect diagram is a picture composed of lines and symbols designed to represent a meaningful relationship between an effect and its causes It was developed by Dr Kaoru Ishikawa in 1943 and is sometimes referred to as an Ishikawa diagram or Fishbone diagram C&E diagrams are used to investigate either a “bad” effect and to take action to correct the causes or a “good” effect and to learn those causes responsible

29. CAUSE AND EFFECT DIAGRAM People Materials Work Methods Measurements Equipment Environment Quality Characteristics CAUSES EFFECTS

30. CAUSE AND EFFECT DIAGRAM For every effect, there are likely to be numerous causes The previous slides shows C&E diagram with the effect on the right and causes on the left The effect is the quality characteristics that needs improvement Causes are usually broken down into the major causes of work methods, materials, measurements, people, and the environment Management and maintenance are also sometimes used for the major cause

31. CAUSE AND EFFECT DIAGRAM Each major cause is further subdivided into numerous minor causes For example under work methods, we might have training, knowledge, ability, physical characteristics, and so forth C&E diagrams are means of picturing all these major and minor causes

32. STEPS TO DRAW A C&E DIAGRAM The first step in the construction of C&E diagram is for the project team to identify the effect or quality problem It is placed on the right side of a large piece of paper by the team leader The major causes are identified and placed on the diagram Determining all the minor causes requires brain storming by the project team Brain storming is an idea generating technique that is well suited to the C&A diagram It uses the creative thinking capacity of the team

33. ESSESTIALS FOR C&E DIAGRAM Participation by all members in a turn wise manner Quantity of ideas rather than quality of ideas is encouraged A simple idea may lead a more useful idea A chain reaction of ideas may be created Criticism of ideas is not allowed All ideas are placed on the diagram and are evaluated latter Visibility of the diagram is a primary factor of participation Create a solution oriented atmosphere and not a gripe session Focus on solving the problem rather than discussing how it began Let the ideas incubate for a period of time (at least overnight) and then have another brain storming session When no more ideas are generated the brain storming activity is terminated

34. EVALUATION OF C&E DIAGRAM The C&E diagram is evaluated to determine the most likely causes in a separate session The procedure is to have each person vote on the minor causes Team members may vote on more than one cause, and they do not need to vote on a cause they presented Those causes with the most votes are circled, and the four or five most likely causes are determined

35. SOLUTION DEVELOPMENT Solutions are developed to correct the causes and improve the process Criteria for judging the possible solutions include cost, feasibility, resistance to change, consequences, training and so forth Once the solutions have been agreed to by the team testing and implementation follow Diagrams are posted in key locations to stimulate continued reference as similar or new problems arise The diagrams are revised as solutions are found and improvements are made

36. SALIENT FEATURES OF C&E DIAGRAM The C&E diagrams have numerous applications in research, manufacturing, marketing, office operations, and so forth One of its strongest aspects is the participation and contribution of everyone involved in the brainstorming process

37. APPLICATION OF C&E DIAGRAM Analyzing actual conditions for the purpose of product or service quality improvement, more efficient use of resources, and reduced costs Elimination of conditions causing nonconforming product or service and customer complaints Standardization of existing and proposed operations Education and Training of personnel in decision making and corrective action activities

38. Example

39. Example

40. TYPES OF C&E DIAGRAMS Cause-enumeration – the one already discussed Dispersion Analysis Process Analysis

41. DISPERSION ANALYSIS The dispersion type of C&E diagram looks just like the cause-enumeration type when both are complete The difference is in the approach to construct it For this type, each major branch is filled in completely before starting work on any other branches Also objective is to analyze the causes of dispersion or variability

42. PROCESS ANALYSIS This type of C&E diagram looks different from the first two types In order to construct this diagram, it is necessary to write each step of the production process Steps in production process such as load, cut, bore, c’sink , chamfer, and unload become the major causes, as shown in the figure on next slide

43. PROCESS ANALYSIS Load Cut Bore C’Sink Chamfer Unload Off Centre Setup Lubrications Roughness Tool Wear Advance Vibration Centering Centering Speed Angle Psi Speed Tool Angle Location Length Wear Wear Wear Wear Wear Check Tool

44. PROCESS ANALYSIS Minor causes are then connected to major causes This C&E diagram is for elements within an operation Other possibilities are operations within a process, an assembly process, a continuous chemical process, and so forth The advantage of this C&E diagram is the ease of construction and its simplicity, since it follows the production sequence

45. Check Sheets Process Flow Diagrams Scatter Diagrams Histograms Control Charts

46. CHECK SHEETS The main purpose of check sheets is to ensure that the data are collected carefully and accurately by operating personnel for process control and problem solving Data should be presented in such a form that it can be quickly and easily used and analyzed The form of the check sheet is individualized for each situation and is designed by the project team

47. Advantages Effective way of displaying data Easy to use Can identify the root cause of a problem A first step in the construction of other graphical tools Provides a structure for uniform data collection Can be used to substantiate or refute allegations

48. How to construct a check sheet Clearly define what events (problem or process) are to be recorded Add a category of other to capture incidents not easily categorized into any of the specified groups Define the period for data recording and suitable intervals The time period should be representative (that is, a one day sample on Monday may not be representative of a typical day ) Design the check sheet to be used during data recording, allocating space for recording, and for summarizing within the intervals and the entire recording period

49. EXAMPLE A book store located in a large shopping mall consistently achieved lower sales per day than budgeted The staff noted that quite a few customers came into the store to browse, but left without buying anything When considering this problem (not tapping the customer base potential there), a wide range of possible causes surfaced including: The customers did not find what they were looking for The staff did not offer the necessary help Sought items were temporarily sold out Sought items were not carried by the store Prices were too high

50. EXAMPLE There was too long a line at the checkout counter Certain types of credit cards were not accepted Lighting was poor in some areas of the store There were no places to sit and look through books before deciding to buy The difficultly in identifying the actual problem and how often it occurred make it difficult for the store personnel to implement any changes Thus, during a two week period, many of the customers leaving without making purchases were courteously asked why this happened The responses were logged in a check sheet, shown below, and give a much clearer idea of where to start to improve the situation

51. EXAMPLE

52. CHECK SHEET Checks are made on a daily or weekly basis, and some checks such as temperature are measured This type of check sheet ensures that a check or test is made

53. EXAMLPLE The figure shows a check sheet for temperature The scale on the left represents the mid point and boundaries for each temperature range Data collection for this type of check sheet is frequently accomplished by placing an x in the appropriate square In this case, the time has also been recorded in order to provide additional information for problem solving

54. GRAPHICAL CHECK SHEET Whenever possible, check sheets are also designed to show location For example, the check sheet for bicycle paint nonconformities could have shown an outline of a bicycle with small x’s indicating location of the nonconformities

55. GRAPHICAL CHECK SHEET xxxxxx x xx xxxxx xxxxxx x Figure shows a check sheet for a 9-cavity plastic mold This check sheet clearly shows that there are quality problems at the upper corner of the mold Creativity plays a major role in the design of a check sheet It should be user friendly and whenever possible, include information on time and location

56. PROCESS FLOW DIAGRAM

57. PROCESS FLOW DIAGRAM For many products and services, it may be useful to construct a flow diagram that shows the flow of the product or service as it moves through the various processing stations or operations The diagram makes it easier to visualize the entire system, identify trouble spots, and locate control activities Standardized symbols are used by industrial engineers; however they are not necessary for problem solving

58. PROCES FLOW DIAGRAM Telephone Fax Letter Log In Credit Check Hold Contract Review Inventory Review Schedule Notify Customer as of Delivery Date Production etc Flow diagram for the order entry activity of a made-to-order company

59. Example (Industrial Process)

60. PROCES FLOW DIAGRAM Enhancements to the diagram are the addition of time to complete an operation and the number of people performing an operation The diagrams shows who is the next customer in the process, thereby increasing the understanding of the process Flow diagrams are best constructed by a team, because it is rare for individual to understand the entire process Improvements to the process can be accomplished by eliminating steps, combining steps, or making frequently occurring steps more efficient

61. SCATTER DIAGRAM

62. SCATTER DIAGRAM The simplest way to determine if a cause-and –effect diagram relationship exists between two variables is to plot a scatter diagram Speed Mileage Independent Variable (Controllable) Dependent Variable

63. SCATTER DIAGRAM Cutting speed and tool life Moisture content and tread elongation Temperature and lipstick hardness Striking pressure and electrical current Temperature and percent foam in soft drinks Yield and Concentration Breakdowns and equipment age

64. STEPS TO PLOT A SCATTER DIAGRAM Data are collected as ordered pairs ( x , y) The horizontal and vertical scales are constructed with the higher values on the right for the x-axis and on the top for the y-axis After the scales are labeled, the data are plotted If two point are identical concentric circles can be used

65. EVALUATION OF SCATTER DIAGRAM Once the scatter diagram is complete, the relationship or correlation between the two variables can be evaluated The next slide shows different patterns and their interpretations

66. EVALUATION OF SCATTER DIAGRAM

67. EVALUATION OF SCATTER DIAGRAM At (a) we have a positive correlation between the two variables because as x increases , y increases At (b) there is a negative correlation between the two variables because as x increases, y decreases At (c), there is no correlation, and this pattern is sometimes referred to as a shotgun pattern The patterns described in (a), (b) and (c) are easy to understand; however those described in (d), (e) and (f) are more difficult

68. EVALUATION OF SCATTER DIAGRAM At (d), there may or may not be relationship between the two variables There appears to be negative relationship between x and y, but it is not too strong Further statistical analysis is needed to evaluate this pattern At (e), we have stratified the data to represent different causes for the same effect One cause is plotted with a small circle, and the their cause is plotted with a solid triangle When the data are separated, we see that there is a strong correlation At (f), we have a curvilinear relationship rather than a liner one

69. EVALUATION OF SCATTER DIAGRAM When all the point fall on a straight line, we have a perfect correlation, but this rarely occurs Curve fitting can also be done on a scatter diagram, either visually or mathematically to drive a trend

70. DATA SUMMARIZATIION AND HANDLING

71. DATA SUMMARIZATION In industry, business, and government the mass of data that has been collected is voluminous Even one item, such as the number of daily billing errors of a large organization, can represent such a mass data that it can be more confusing than helpful These data, in this form , are difficult to use and are not effective in describing the data’s characteristics Some means of summarizing the data are needed to show what value or values the data tend to cluster about and how the data are dispersed or spread out Two techniques are available to accomplish this summarization of data – graphical and analytical

72. DATA SUMMARIZATION The graphical technique is a plot or picture of a frequency distribution, which is a summarization of how the data points (Observations) occur within each subdivision of observed values or groups of observed values Analytical technique summarize data by computing a measure of central tendency and a measure of dispersion Sometimes both the graphical and analytical techniques are used

73. HISTOGRAM Cell Boundaries Cell Midpoint Frequency 2531-2535 2533 6 2536-2540 2538 8 2541-2545 2543 12 2546-2550 2548 13 2551-2555 2553 20 2556-2560 2558 19 2561-2565 2563 13 2566-2570 2568 11 2571-2575 2573 8 Total 110 This frequency distribution gives a better conception of the central value and how the data are dispersed about that value than the unorganized data or tally sheet

74. HISTOGRAM

75. HISTOGRAM The histogram describes the variation in the process It is used to Solve Problems Determine the process quality Compare with Specifications Suggest the shape of the population , and Indicate discrepancies in data such as gaps

76. ANALYSIS OF HISTOGRAM Analysis of Histogram provide information concerning specifications, the shape of the population frequency distribution, and a particular quality problem

77. ANALYSIS OF HISTOGRAM The figure shows a histogram for the %age of wash concentration in a steel tube cleaning operation prior to painting The ideal concentration is between 145 % and 174%

78. ANALYSIS OF HISTOGRAM Concentrations less than 145 % produce poor quality; concentrations greater than 175 %, while producing more than adequate quality, are costly and therefore reduce productivity No complex statistics are needed to show that corrective measures are needed to bring the spread of the distribution closer to the ideal value of 16%

79. ANALYSIS OF HISTOGRAM By adding specifications to the graph, additional problem solving information is created Since the spread of the distribution is a good indication of the process capability, the graph will show the degree of capability

80. VARIATION CONTROL One of the axioms of manufacturing is that no two objects are ever made exactly alike In fact, the variation concept is a law of nature in that no two natural items in any category are the same The variations may be quite large and easily noticeable and in some cases they are not noticeable without the aid of some instruments If two items appear to have the same measurement, it is due to the limits of our measuring instruments

81. VARIATION CONTROL As measuring instruments have become more refined, variations has continued to exist; only the increment of variation has changed The ability to measure variation is necessary before it can be controlled

82. TYPES OF VARIATION CONTROL Within-piece variation This type of variation is illustrated by the surface roughness of a piece wherein one portion of the surface is rougher than another portion, or the width of one end of a keyway varies from the other end Piece –to- piece variation This type of variation occurs among pieces produced at the same time. For example the light intensity of four consecutive light bulbs produced from a machine will be different Time to time variation This type of variation is illustrated by the difference in product produced at different times of the day. Thus, a service given early in the morning would be different from that given later in the day, or as cutting tol wears, the cutting characteristics varies

83. FACTORS AFFECTING VARIATION Equipment Material Environment True Variations Operator Inspection Activity Pg 186

84. VARITION IN PROCESS CONTROL As long as these sources of variation fluctuate in a natural or expected manner, a stable pattern of many chance causes (random causes) of variation develops Chance causes of variation are inevitable Because they are numerous, and individually of relatively small importance, they are difficult to detect or identify Those causes of variations that are large in magnitude , and therefore readily identified, are classified as assignable causes

85. VARITION IN PROCESS CONTROL When only chance causes are present in a process, the process is considered to be in a state of statistical control It is stable and predictable However, when an assignable cause of variation is also present, the variation will be excessive, and the process is classified as out of control or beyond the expected natural variation

86. CONTROL CHART In order to indicate when observed variations in quality are greater than could be left to chance, the control chart method of analysis and presentation of data is used The control chart method for variables is a means of visualizing the variations that occur in the central tendency and dispersion of a set of observations It is a graphical record of quality of a particular characteristic It shows whether or not the process is in a stable state

87. CONTROL CHART Central Line Upper Control Limit Lower Control Limit LCL X UCL X X Subgroup Number Subgroup Average (X)-Kg X Chart

88. CONTROL CHART This particular chart is referred to as X(bar) chart and is used to record the variation in the average value of samples Each small circle represents the average value within a subgroup Thus subgroup No 5 consist of, say, four observations 346 , 349 , 345 and 344 , and their average is 346 This value is the one posted on the chart for subgroup No 5 Averages are used on control charts rather than individual observations because average values will indicate a change in variation much faster With two or more observations in a sample, a measure of the dispersion can be obtained for a particular subgroup

89. CONTROL CHART The solid line in the centre of the chart can have three different interpretations depending on the available data It can be average of the plotted points, which in the case of an chart is the average of the averages or “X double bar,” It can be standard or reference value, , based on representative prior data, an economic value based on production costs or service needs, or an aimed-at value based on specifications It can be population mean, μ , if that value is known

90. CONTROL CHART The two dashed outer lines are the upper and lower control limits These limits are established to assist in judging the significance of the variation in the quality of the product Control limits are frequently confused with specification limits , which are permissible limits of a quality characteristic of each individual unit of a product Whereas, Control Limits are used to evaluate the variation in quality from subgroup to subgroup. Therefore the control limits are a function of the subgroup averages

91. OBJECTIVE OF VARIABLE CONTROL CHARTS For quality improvement To determine the process capability For decisions in regard to product specifications For current decisions in regard to production process For current decisions in regard to recently produced items

92. CASE STUDY FOR PROCESS CONTROL

93. CONCLUSION When the objective for initiating the charts has been achieved, its use should be discontinued or the frequency of inspection be substantially reduced to a monitoring action by the operator Efforts should then be directed towards the improvement of some other quality characteristic If a project team was involved it should be congratulated for its performance and disbanded

94. ACCEPTANCE SAMPLING I n recent years, acceptance sampling has declined in importance and as statistical process control has assumed a more prominent role in the quality function However, acceptance sampling still has a place in the entire body of knowledge that constitutes quality science Lot-by-lot acceptance sampling by attributes is the most common type of sampling

95. ACCEPTANCE SAMPLING With this type of sampling, a predetermined number of units (sample) from each lot is inspected by attributes If the number of nonconforming units is less than the prescribed minimum, the lot is accepted; if not, the lot is not accepted Acceptance sampling can be used either for the number of nonconforming units or for nonconformities per unit

96. ACCEPTANCE SAMPLING Acceptance sampling can be performed in a number of different situations where there is a consumer-producer relationship The consumer and producer can be from from two different organizations, two plants within the same organizations, or two departments within the same facility In any case, there is always the problem of deciding whether to accept or not the product

97. OCCASIONS When test is destructive (such as a test on an electrical fuse or a tensile test), sampling is necessary; otherwise, all of the product will be destroyed by testing When the cost of 100% inspection is high in relation to the cost of passing a nonconforming unit When there are many similar units to be inspected, sampling will frequently produce as good, if not better, results than 100% inspection Human fatigue in lengthy inspection is one factor When information concerning producer’s quality, such as X and R, p or c charts, and C pk , is not available When automated inspection is not available

98. ADVANTAGES Places responsibility for quality in the appropriate place rather than on inspection, thereby encouraging rapid improvement in the product Is more economical owing to fewer inspections (fewer inspectors) and less handling damage during inspection Upgrades the inspection job from monotonous piece-by-piece decisions to lot-by-lot decisions Applies to destructive testing Entire lots are not accepted rather than the return of a few nonconforming units, thereby giving stronger motivation for improvement

99. ADVANTAGES There are certain risks of not accepting conforming lots and accepting non-conforming lots More time and effort is devoted to planning and documentation Less information is provided about the product, although there is usually enough There is no assurance given that the entire lot conforms to specifications

100. RELIABILITY Reliability is the ability of a product to perform its intended function over a period of time A product that works over a long period of time is a reliable one

101. DESIGN OF EXPERIMENT (DOE) The objective of DOE is to determine those variables in a process or product that are the critical parameters ad their target values Bu using formal experimental techniques, the effect of many variables can be studied at one time Changes to the processor product are introduced in a random fashion or by carefully planned highly structured experiments

102. APPROACHES TO DOE There are three approaches to DOE: Classical Taguchi Shainin Since DOE identifies the critical parameters and their target values, its use should actually precede SPC in many circumstances It is not useful to find after an experiment that SPC was controlling the wrong variable or the target was incorrect Used extensively in Product Design and Development

103. TAGUCHI’s QUALITY ENGINEERING Most of the body of knowledge associated with the quality was developed in the United Kingdom as DOE and in US as SQC Dr Geinichi Taguchi, a mechanical engineer has added to this body of knowledge He introduced the loss function concept, which combines cost, target, and variation into one metric with specifications being of secondary importance He also developed the concept of robustness, which means that noise factors are taken into account to ensure that the system functions correctly Noise factors are uncontrollable variables that can cause significant variability in the process, product, or service

104. FAILURE MODE AND EFFECT ANALYSIS (FMEA) FMEA is an analytical technique that combines the technology and experience of people in identifying foreseeable failure modes of a product, service, or process and planning for its elimination In other words, FMEA can be explained as a group of activities intended to: Recognize and evaluate the potential failure of a product, service, or process and its effects Identify actions that could eliminate or reduce the chance of the potential failure occurring Document the process

105. FAILURE MODE AND EFFECT ANALYSIS (FMEA) FMEA is a “before-the-event” action requiring a team effort to alleviate most easily and inexpensively changes in design and production There are two types of FMEA: Design FMEA Process FMEA

106. QUALITY FUNCTION DEPLOYMENT (QFD) QFD is a system that identifies and sets the priorities for product, service and process improvement opportunities that lead to increased customer satisfaction It ensures that the accurate deployment of the “voice of the customer” throughout the organization from product planning to field service The multi-functional team approach to QFD improves those processes necessary to provide goods and services that meet or exceed customer expectations

107. QFD ASKS? What do customers want? Are all wants equally important? Will delivering perceived needs yield a competitive advantage? How can we change the product, service, or process? How does an engineering decision affect customer perception? How does an engineering change affect other technical descriptors? What is the relationship to parts deployment, process planning and production planning?

108. ADVANTAGES QFD reduces start-up costs Reduces engineering design changes Leads to increased customer satisfaction

109. NON QUANTITATIVE TECHNIQUES

110. ISO 9000 ISO stands for International Organization for Standards The 9000 series is a standardized Quality Management System (QMS) that has been approved by over 100 countries It consists of three standards ISO 900- Covers fundamental and vocabulary ISO 9001- Define requirements ISO 9004- Provides guidance for performance improvement

111. INTRODUCTION The requirements define the criteria for an acceptable QMS The five clauses of QMS are: Continual Improvement Management Responsibility Resource Management Product / Service realization Measurement , Analysis and Improvement

112. INTRODUCTION 6 Resource Management 4 QMS Continual Improvement 5 Management Responsibility 8 Measurement Analysis and Implementation 7 Product / Service Realization Customer Satisfaction Input Requirements Output Product / Service Model of a process-based Quality Management System

113. QUALITY MANAGEMENT SYSTEM General Requirements In regard to QMS an organization shall Establish Document Implement Maintain

114. 4 QMS 4.1 General Requirements Identify needed processes such as management activities, provision of resources, product or service realization and measurement Determine their sequence and interaction Determine criteria and methods for effective operation and control of these processes Ensure the availability of resources and information necessary to support and monitor these processes Monitor, measure and analyse these processes Implement actions to achieve planned results and continual improvement of these processes Outsources processes that affect the quality of the product shall be identified and included in the system

115. 4.2 Documentation 4.2.1 General Documentation shall include Statement of quality policy and quality objectives A quality manual Required documented procedures Needed documents to ensure effective planning, operation, and control of processes Required records Type and extent of documentation depends on the nature, size and working of organization; complexity of processes; competency of employees etc

116. 4.2.2 Quality Manual A quality manual shall be established and maintained that includes The scope of the QMS with details and justification for any exclusions The documented procedures or references to them A description of the interaction among the QMS processes

117. 4.2.3 Control of Documents A documented procedure shall be in control to define the controls needed to Approve documents prior to use Review, update, and re-approve as necessary Identify the current revision status Ensure that current versions are available at the point of use Ensure that documents are legible and readily identified Identify and distribute documents of external origin Provide for the prompt removal of obsolete documents and suitably identify any that may be retained

118. 4.2.4 Control of Records Records shall be established and maintained to provide evidence of conformity to requirements and the effective operation of the QMS They shall be legible, readily identifiable, and retrievable A documented procedure shall be established to define the controls needed for the Identification Storage Protection Retrieval Retention time Disposition of record

119. 4.2.4 Control of Records Records can be used to document traceability and to provide evidence of Verification Preventive action Corrective action

120. 5 MANAGEMENT RESPONSIBILITY 5.1. Management Commitment Top management (Person or group of people who direct and control an organization) shall provide evidence of its commitment to the development, implementation, and continual improvement of the QMS by Communicating the need to meet customer, legal and regulatory expectations Establishing a quality policy Ensuring that quality objectives are established ] Conducting management reviews Ensuring the availability of resources

121. 5.2 Customer Focus Top management shall ensure that customer requirements are determined and met in order to enhance customer satisfaction

122. 5.3 Quality Policy Top management shall ensure that the quality policy Is aligned with the organization’s purpose or mission Includes a commitment to comply with requirements and continually improve the effectiveness of QMS Provides a framework to establish and review the quality objectives Is communicated and understood throughout the organization Is periodically reviewed for continuing stability The policy gives the overall intentions and direction of the organization related to quality

123. 5.4 Planning 5.4.1 Quality Objectives Top management shall ensure that quality objectives are established at relevant functions and levels within the organization and include product and service requirements They shall be measureable and consistent with the quality policy They should ensure that customer expectations are met For example finishing department scrap will be reduced from 5% to 43 % and the first line supervisor is the person responsible

124. 5.4.2 QMS Planning Top management shall ensure that the planning of the QMS is accomplished in order to meet the requirements of the QMS as stated in the general requirements and quality objectives In addition, the integrity of the QMS is maintained when changes are planned and implemented

125. 5.5 Responsibility, Authority and Communication 5.5.1 Responsibility and Authority Top management shall ensure that responsibilities and authorities are defined and communicated within the organization Responsibilities can be defined in job descriptions, procedures, and work instructions Authorities and interrelationships can be defined in an organization chart

126. 5.5.2 Management Representation A member of management , shall be appointed regardless of his / her other duties, and have the responsibility and authority that includes ensuring that Processes needed for the QMS are established , implemented, and maintained Reports are given to top management on the performance of the QMS and any need for improvement Promoting the awareness of customer requirements throughout the organization Appointment of a member of top management as MR can contribute to the effectiveness of the QMS

127. 5.5.3 Internal Communication Top management shall ensure that appropriate communication channels are established within the organization and that communication takes place regarding the effectiveness of the QMS Typical communication techniques are management workplace briefing, recognition of achievement, bulletin boards, e-mail, and in-house news brochers

128. 5.6 Management Review 5.6.1 General Top management shall periodically review the QMS to ensure its continuing suitability, adequacy, and effectiveness This review shall include assessing opportunities for improvement and the need for changes to the QMS including the policy and objectives Records from the review shall be maintained

129. 5.6.2 Review Input The review shall include information on Audit results Customer Feedback Process, product and service performance Corrective and preventive performance Follow-up actions from previous reviews Changes that could affect the QMS Improvement recommendations

130. 5.6.3 Review Output The output shall include any decisions and actions related to Improvement of the effectiveness of the QMS and its processes Improvement of the product and service related to customer requirements Resource needs Top management can use the outputs as inputs to improve opportunities

131. 6 Resource Management 6.1 Provision of Resources The organization shall determine and provide the resources needed To implement, maintain, and continually improve the QMS To enhance customer satisfaction Resources may be people, infrastructure, work environment, information, supplies, natural resources Resources can be aligned with quality objectives

132. 6.2 Human Resources 6.2.1 General Personnel performing work that affects product or service quality shall be competent on the basis of appropriate Education Training Skill Experience

133. 6.2.2 Competence, Awareness and Training The organization shall Determine the necessary competence for personnel performing work affecting product / service quality Provide training or take other actions to satisfy these competencies Evaluate the effectiveness Ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives Maintain appropriate records

134. 622 Competence, Awareness and Training Competency is defined as the demonstrated ability to apply knowledge and skills It can be contained in the job description by function, group or specific position Training effectiveness can be determined by before and after tests, performance or turnover

135. 6.3 Infrastructure The organization shall determine, provide, and maintain the infrastructure needed to achieve conformity to product or service requirements Infrastructure includes (as applicable) Buildings, workspace, and associated utilities Hardware and software process equipment Supporting services such as transport or communication

136. 6.4 Work Environment The organization shall determine the work environment needed to achieve conformity to product or service requirements Creation of a suitable work environment can have a positive influence on employee motivation, satisfaction and performance

137. 7 Product Realization 7.1 Planning of Product Realization The organization shall plan and develop the processes needed for product or service realization Planning of product or service realization shall be consistent with the requirements of other processes of QMS In planning product or service realization, the organization shall determine the following, (as appropriate)

138. 71 Planning of Product Realization In planning product or service realization, the organization shall determine the following, (as appropriate) Quality objectives and requirement for the product or service The need to establish processes, documents, and provide resources specific to the product or service Required verification, validation, monitoring, inspection and test activities specific to the product or service Records needed to verify this clause

139. 7.2 Customer Related Processes 721 Determination of requirements related to the product Requirements specified by the customer Other requirements necessary for specified or intended use Statutory and regulatory requirements Any additional requirements determined by the organization

140. 7.2.2 Review of Requirements related to the product The org shall review the requirements related to the product or service The review shall be conducted prior to the org’s commitment to supply a product or service to the customer Product / service requirement s are defined All difference resolved The org has the ability to meet the defined requirements All records must be maintained

141. 7.2.3 Customer Communication The org shall determine and implement effective arrangements for communicating with customers in relation to Product or service information Inquires and documentation Customer feedback

142. 7.3 Design and Development 7.3.1 Design and Development Planning The org shall plan and control the design and development of the product During the planning The design and development stages Review and validation of each development stage Responsibilities and authorities for the stages Proper management of interfaces

143. Design & Development 732 Design and Development Inputs 733 Design and Development Output 734 Design and Development Review 735 Design and Development Verification 736 Design and Development Validation 737 Control of Design and Development Changes

144. 7.4 Purchasing 7.4.1 Purchasing Process Purchased product shall confirm to specified purchase requirements The org shall evaluate and select suppliers based on their ability to supply product or service in accordance with the org’s requirements 7.4.2 Purchasing Information 7.4.3 Verification of Product purchased

145. 7.5 Product and Service Provision 7.5.1 Control of Production and Service Provision The org shall plan and carry out production and service provision under controlled conditions Information that describes the product / service Work instructions Use of suitable equipment Use of monitoring and measuring devices Implementation of monitoring / measurement Implementation of release, delivery, and post delivery activities

146. 7.5 Product and Service Provision 7.5.2 Validation of process for production and service provision 7.5.3 Identification and Traceability 7.5.4 Customer Property 7.5.5 Preservation of Product

147. 7.6 Control of Monitoring and Measuring Devices The organization shall determine the scope of the monitoring and measurement activity to provide evidence of conformity of product or service to requirements Process shall be established to ensure that monitoring and measurements are carried out in a manner that is consistent with the monitoring and measurement requirements

148. 7.6 Control of Monitoring and Measuring Devices Measuring equipment shall be Calibrates or verified at specific intervals Be adjusted or readjusted as necessary Be identified to enable calibrations status to be determined Be safeguarded from adjustments that would invalidate the measurement results Be protected against damage and deterioration during handling, maintenance, and storage

149. 8 Measurement, Analysis, and Improvement 8.1 General The org shall plan and implement the monitoring, measurement analysis, and improvement processes needed to To demonstrate conformity of the product or service To ensure conformity of the QMS To continually improve the effectiveness of the QMS

150. 8.2 Monitoring and Measurement 8.2.1 Customer satisfaction 8.2.2 Internal Audits 8.2.3 Monitoring and Measurement of Processes 8.2.4 Monitoring and measurement of product and service

151. 8 Measurement, Analysis, and Improvement 8.3 Control of non-conforming product 8.4 Analysis of data 8.5 Improvement 8.5.1 Continual Improvement 8.5.2 Corrective action 8.5.3 Preventive action

152. INTERNAL AUDITS After the policies, procedures, and work instructions have been developed and implemented, checks must be made to ensure that the system is being followed and the expected results are being obtained This activity is accomplished through the internal audit, which is one of the key elements of the ISO-9000 standards All elements should be audited at least once per year and some more frequently, depending on need

153. Objectives Determine that actual performance confirms to the documented QMS Initiate corrective action activates in response to deficiencies Follow up on noncompliance items from previous audits Provide continued improvement in the system through feedback to management Cause the auditee to think bout the process, thereby encouraging possible improvement

154. AUIDTOR Audits should be performed by qualified individuals who have received training in auditing principles and procedures Training program are available with PIM and PIQM Training should include classroom information as well as practical demonstration by the trainer and a critiqued audit by trainee

155. ATTRIBUTES OF AUDITOR Good written and oral communication skills Be a good listener Be good at taking notes Should be able to concentrate on the task at hand Be observant and questioning Be able to separate relevant facts with other information Should be objective, honest, and impartial Be prepared and knowledgeable

156. TECHNIQUES Examination of Documents Observation of activities Interviews

157. Examination of Documents Documents are identified with a title, revision date, and responsible owner Documents are readily available to user A master list by department or function for procedures, work instructions, and records is appropriately located There are no obsolete documents at work stations Changes follow a prescribed procedure

158. Observation of Activities Observation of activities is also an easy method that requires an aptitude for details For example, to evaluate the preservation of product, the auditor would observe the identification, handling, packaging, storage, and protection of the product

159. Interviews Place the auditee in a non-threatening environment by starting with introductions and an explanation of the purpose of audit Spend as much time listening and as little time as possible talking If you find deficiencies, separate major and minor Reserve the major issues for the report and minor ones for the auditee Focus on system and not on auditee

160. Interviews Discuss the major issues informally with the auditee first Be sure that auditee understands and agree to the problem Sometime an auditor, based on his experience will have an idea that might solve the problem It should be discussed in such a way that auditee believes that it is his / her idea

161. Interviews Types of questions Open questions Close Questions Clarifying question Leading questions Aggressive question

162. PROCEDURE OF AUDITS Before an audit takes place, an audit plan and check list should be prepared by the lead auditor As much time is spent planning as doing All details of concerned department should be covered

163. PROCEDURE OF AUDITS The procedure of audit has three parts The pre-audit meeting The Audit Closing meeting The auditors are escorted by a staff member of auditee (Usually a senior person) The audit findings should be written out in detail from the auditors notes and should include the conforming as well as non-conforming items