Continual Improvement Corrective and Preventive Actions

Transcription

1 Continual Improvement Corrective and Preventive Actions Tuesday 23 May 2006 John E. (Jack) West & Oscar Lopez 1

2 Basic Topics The Improvement Process Alignment Corrective Action and Preventive Action Actions 2

3 Basic Topics The Improvement Process Alignment Corrective Action and Preventive Action Actions 3

4 The Improvement Process Tools and tactics for getting better 4

5 The Improvement Process Understanding Continual Improvement Policy and Objectives Process Management Measurement and Data Collection Analysis of Data Measuring Results and Management Review 5

6 Understanding Continual Improvement UP Is good Continual improvement TIME UP Is good Continuous improvement TIME 6

7 Basic requirements for continual improvement Improve the effectiveness of the system by improving the processes! ISO 9001 clause continually improve the effectiveness of the quality management system ISO 9001 clause 4.1f implement actions necessary to achieve continual continual improvement of these processes. 7

8 Requirements for Planned Continual Improvement Policy (5.3) Objectives (5.4.1) Measures (8.2) Product & Process Customer satisfaction Audit results Planning 5.4.2, 8.1 Data collection (8.4) Management review (5.6) Inputs Outputs Monitor progress Corrective action (8.5.2) Preventive action (8.5.3) Identify opportunities (8.4 & 5.6) Analysis of data (8.4) 8

9 Continual Improvement: Incremental and Breakthrough See ISO 9004:2000 Annex B Breakthrough Target: Be 5% Better than Benchmark In 18 Months Benchmark: Best in Class Performance Incremental Improvements Over Five Years UP Is good Breakthrough in 18 Months Five Years TIME 18 Months 9

10 Continual Improvement: Incremental and Breakthrough Characteristics Tendency Incremental Improvement Breakthrough Improvement People Involved People working in the process Managers, engineers, consultants Size of Changes Small incremental changes Big changes Types of Changes Practices, procedures, equipment modifications, elimination/simplification of activities, process fool-proofing Technology, new equipment, major process upgrades, process re-engineering Results Small improvements Large jumps in performance Cost of Projects Low, generally included in operating budget High, may involve capital investment 10

11 Focus the System on Improvement Driven by Top Management Continually Improving Effectiveness Process Process Process Process Process Network of Interrelated Processes Focused O B J E C T I V E S S T A K E H O L D E R S Improving ability to meet objectives Objectives set with improving performance in mind 11

12 The Improvement Process Understanding Continual Improvement Policy and Objectives Process Management Measurement and Data Collection Analysis of Data Measuring Results and Management Review 12

13 Policy and Objectives Policy Commitment to meet requirements Commitment to improvement Objectives Set with policy in mind Identify key drivers of performance 13

14 Key Drivers Of Performance Revenue - Cost = Profit Better Products Customer Satisfaction Fewer Rejects Less Returns Less Problems + = Maybe You Get a Bonus Revenue Drivers Cost Drivers Better Quality Higher Revenue and Lower Cost 14

15 Improvement Measuring Quality Objective Monitoring Analysis of Data Analyzing Establish Quality Policy Quality Objective Improving Quality Objective Planning Audit Results Quality Management System Corrective & Preventive actions Management Review 15

16 How does your organization make improvements? Your actions: 16

17 The Improvement Process Understanding Continual Improvement Policy and Objectives Process Management Measurement and Data Collection Analysis of Data Measuring Results and Management Review 17

18 Process Management Requirements for the process approach Purpose Of Process Management Basic tools of process management 18

19 Clause 4 Quality management system 4.1 General requirements Establish, implement, document, maintain, and continually improve the QMS processes; this includes: Defining their sequence and interactions Managing the QMS processes Establishing criteria and methods to operate and control the QMS processes Ensuring availability of information to operate and monitor the QMS processes Measuring, analyzing and continually improving the QMS processes Provide for control of outsourced processes 19

20 Clause 4.1 General Requirements The organization shall... Continually Improve Document Establish Maintain Implement Quality Management System 20

21 Quality Management System Identify processes 21

22 Quality Management System Determine sequence & interaction 22

23 Determine methods to operate & control processes Quality Management System 23

24 Ensure availability of resources & information Quality Management System Resources 24

25 Measure, monitor & analyze processes Quality Management System Measure at key points 25

26 Process Management Requirements for the process approach Purpose of process management Basic tools of process management 26

27 Purpose Of Process Management Control Understand the processes and how they fit together Understand relationship between response and independent process variables Control the process Y Response Variable Motion of the Car Kid With the Control! 27

28 Purpose Of Process Management Simplify processes Reduce variability in both independent and response variables Improve control and ability to meet process targets Improve output performance improvement 28

29 Process Management Requirements related to process approach Purpose Of Process Management Basic tools of process management 29

30 Basic tools of process management Map Control Process Analyze Improve The key to process management is measurement! 30

31 Map the Key Processes 31

32 Start With Process Outputs Inputs Process Product Design Outputs To Identify outputs ask questions: What are the outputs of the process Who are the customers of the outputs How do those customers use the output How should the output be measured Involve the people working in the process Talk to the customers of the process 32

33 Start With Process Outputs Process These are just some examples, your process may have many outputs, customers, targets and results. Product design Outputs - A simple example Outputs Customer Target Current Results Designs that meet user needs Specifications for process development Ultimate product users Process Engineering No complaints 6-month product cycle No process budget variance due to design issues No complaints 12 month design cycle $100,000 over process budget for last year due to design issues 33

34 Define the Process Inputs These are just some examples, your process may have many inputs, suppliers, targets and results. A simple example - Inputs Process Product Design Inputs Supplier Target Current Results Requirements of specific customers Market needs for new products Sales Department Marketing Zero orders returned to sales for more information New product needs 12 months out 50% of orders returned for more data over last 12 months Last ten products defined 10 to 12 months out 34

35 Targets Not Met are Opportunities for Improvement 35

36 Flow Chart The Process Inputs Suppliers Targets Results Product Design Process Outputs Customers Targets Results 36

37 Flow Chart The Process Controls Inputs Suppliers Targets Results Product Design Process Resources Outputs Customers Targets Results 37

38 Map the Process-- --As IS Use simple flow charts for the process flow Record data related to the process targets for key process activities Defect trends Resources Process capability Etc. Process maps are more than just flow charts: they are supported by data Chart the process as it actually works NOW, Don t t make changes yet 38

39 Analyze the Maps to find Improvements 39

40 Analyze Data to Find and Act on Opportunities Use Simple Analytical Tools Use Process Failure Mode and Effects Analysis PFMEA Define potential process failures and their effects Determine potential causes Prioritize and take action on high priority issues 40

41 Pareto of Output Issues Customer Complaints & Returns Viscosity Late Color Price Process Output Issues for a Chemical Process 41

42 Analyze Data to Find and Act on Opportunities Use Simple Analytical Tools Use Ishikawa fishbone diagrams Find potential X variables that control process output Involve the people who work in the process Use data to understand which variables are the important ones 42

43 Analyze Data to Find and Act on Opportunities Use Simple Analytical Tools materials methods machine Effect measurement man Ishikawa Cause and Effect Fishbone Diagrams 43

44 Analyze Data to Find and Act on Opportunities Use Simple Analytical Tools materials methods machine Feed stock contamination Temperature settings Manual controls Age of feedstock Flow rate Gages out of calibration Reactor age Training Wrong Viscosity Measurement capability Experience measurement man 44

45 Analyze Data to Find and Act on Opportunities Use Simple Analytical Tools Y Customer Requirement X Process Variable 45

46 Analyze Data to Find and Act on Opportunities Use Simple Analytical Tools Y Customer Requirement Viscosity X i Process Variable X 1 Reactor Temperature X 2 Feedstock Chemistry (% Contaminant) X 3 Flow Rate GPM 46

47 Analyze Data to Find and Act on Opportunities Use Simple Analytical Tools New Range (Tolerance) Y Customer Requirement Viscosity Our Range (Tolerance) X 2 Feedstock Chemistry (% Contaminant) Range Customer Needs 47

48 Analyze Data to Find and Act on Opportunities Use Simple Analytical Tools New Range Y Customer Requirement Viscosity Our Range (Tolerance) Range Customer Needs X 3 Flow Rate (GPM) 48

49 Improvement Administrative Distribution representing a reports delivery process > too many defects (unhappy customers) + mean too high (3.2 weeks): how to improve within the (green) limits? A Frequency Exceeds expectations unnecessarily Defects: Unacceptable to shareholders who expect report within 4 weeks max (voice of customers) 1 weeks 2 weeks 3 weeks 4 weeks 5 weeks 6 weeks Time to complete quarterly financial report (annual statistics) 49

50 Frequency Improvement - Administrative 2 possible improvements: 1) Mean A to B = Move the mean to the left 2) Curve A to Curve B = Reduce variations B A Reduce variability = Process more robust = Process under control Remove defects 1 weeks 2 weeks 3 weeks 4 weeks 5 weeks 6 weeks Time to complete quarterly financial report (annual statistics) 50

51 Six Sigma σ (sigma): Statistical unit of measurement that defines the standard deviation of a population. (Definition: Point of inflection on the normal l curve.) Measure of variability or spread of the data, that indicates how much of the data falls within the customers requirements. The higher the process sigma, the more of the process outputs, products and services, meet customers requirements or, the fewer the defects. 6 Sigma means the population is within the +/- 6 x standard deviation limits (*). What is not within these limits is called defect. 1σ 6σ * with 1.5 Sigma shift 51

52 Three Basic Six Sigma Methods DMAIC The most common 6 Sigma To improve an existing process Define > Measure > Analyse > Improve > Control Focuses on real problems directly related to the bottom-line Start realizing results after 6 months DMEDI (DFSS) Focuses on development of new products,, services, processes, and plants that precisely meet customer current and future needs Define > Measure > Explore > Develop > Implement Utilizes multiple tools and techniques including rigorous statistical methods Sustains improvement over the long-term Disseminates improvement throughout the organization Acts as an agent of change LEAN 6 SIGMA An approach & set of tools to improve supply chain responsiveness, as a mix of lean manufacturing (Kanban( Kanban, 5S, JIT) and 6 Sigma 5 principles: : Value, Value stream, Flow, Pull, Perfection Reduction of lead, cycle time, throughput, WIP, waste > Velocity Can achieve results in few weeks 7 zeros: : Defects, Excess, Set ups, Breakdowns, Handling, Lead times, Surging 52

53 The Improvement Process Understanding Continual Improvement Policy and Objectives Process Management Measurement and Data Collection Analysis of Data Measuring Results and Management Review 53

54 What does your organization measure? Your actions: 54

55 Clause 8.2 Monitoring and measurement Is there a difference between Monitoring And Measurement If so, what is it 55

56 Measurement Means ascertain or determine the spatial magnitude or quantity of (something) ascertain or determine (a spatial magnitude or quantity) by the application of some object of known size or capacity or by comparison with some fixed unit Fancy way to say putting a number on something! 56

57 Monitor Means observe, supervise, keep under review measure or test at intervals, especially for the purpose of regulation or control 57

58 Clause 8.2 Monitoring and measurement Customer satisfaction information Monitor Auditing the QMS (All?) product characteristics (All?) Processes Measure Key product characteristics Important parameters of key processes 58

59 Measurement and Data Collection Measurement is the Key to Success What Gets Measured Gets Done The key to improvement is measuring the right things in the right way 59

60 Clause 8.2 Monitoring and measurement Clause Customer satisfaction Monitor information on: customer perceptions of whether the organization has met customer requirements The organization defines the methods and measures for obtaining and using the information 60

61 8.2.1 Customer satisfaction Measuring Monitoring Customer satisfaction data Improving Analyzing Define how data is used 61

62 One Approach Start by asking questions : What customer information do you have? What customer information do you want? Do you want your own internal customer study capability? Do you want to selectively go to the outside for specific research projects? 62

63 Sources of Customer Satisfaction Data Methods of of Gathering Active Receptive Indirect Surveys Focus groups Site visits Interviews Complaints Warranty costs Allowances Letters Articles Trade Shows Repeat business 63

64 Key Measures Trade Shows R&D Sales Calls Surveys Articles Credits & Returns Complaints Customer Ratings Often our customer data is like an incomplete puzzle 64

65 Key Measures Sales Calls Credits & Returns Trade Shows Surveys Complaints R&D Articles Customer Ratings Get the pieces to fit together 65

66 Clause Internal audit Conduct internal quality audits at planned intervals Does QMS conform to ISO9001 Is QMS effectively implemented Schedule audit based on importance of functions and prior results Conduct internal audits 66

67 8.2.2 Internal audit Take corrective action when necessary and follow-up to assure effectiveness Assure auditors are objective and impartial Use data from internal audits in the improvement process 67

68 Clause Monitoring and measurement of processes Apply suitable measures to processes as necessary to: meet customer requirements demonstrate process continuing ability to satisfy its intended purpose take appropriate correction and corrective action for nonconforming processes to ensure conforming product Measures become an input to improve processes 68

69 Monitoring of Processes All processes MBWA Day to day supervision Monitoring on-line Alarms Other methods 69

70 Measurement of Processes Measure key processes Processes related to key driver results What to measure Response variables (outputs) Independent variables (inputs, process parameters) Y Response Variable Sweet Taste Independent Variable Amount of Sugar 70

71 Clause Monitoring and measurement of product Apply suitable measures to characteristics of products to verify the requirements for the product are met 71

72 Cost of Quality Not an ISO 9001 requirement But Can be the best overall quality measure of all 72

73 COQ Typically runs from 10% to 25% of sales when measured conservatively! Offers huge cost reduction opportunities Can identify opportunities to really identify waste Can improve customer satisfaction and revenues 73

74 Cost of Quality Savings Prevention Appraisal External Failure Internal Failure Initial Later 74

75 COQ Links to key drivers of performance Key Processes People involved in Projects for improvement Measures Results: Higher revenue Lower failure costs 75

76 COQ Definition Prevention Costs-- --Costs associated with helping the employee do his or her job right the first time. Appraisal Costs-- --Costs of monitoring, measuring, and testing to ensure conformance to customer expectations. 76

77 COQ Definition Internal Failure Costs-- --Costs associated with mistakes that are fixed before the customer receives the product or service External Failure Costs-- --Costs of errors or mistakes that the customer sees. 77

78 COQ Can Work on Both Cost and Revenue COQ $ Year 1 Year 2 Year 3 Prevention Appraisal Int. Failure Ext. Failure Eliminating internal failure reduces cost Eliminating external failure can also improve customer satisfaction 78

79 Measurement Capability Measurements must be accurate Measurement capability is often overlooked resulting in misleading data 79

80 Analysis of Data Omnipresent Variability Leads to Ubiquitous Uncertainty A quote from Dorian Shanin 80

81 Measurement Accuracy Four Situations Centered & Precise Accurate Individual Measurements Centered But Not Precise Low Probability of Accurate Individual Measurement Precise But Not Centered Low Probability of Accurate Individual Measurement Not Precise And Not Centered Low Probability of Accurate Individual Measurement Target center is the actual value 81

82 What should your organization be measuring? Your actions: 82

83 The Improvement Process Understanding Continual Improvement Policy and Objectives Process Management Measurement and Data Collection Analysis of Data Measuring Results and Management Review 83

84 Clause 8.4 Analysis of data Collect and analyze appropriate data to determine suitability and effectiveness of the quality management system evaluate where continual improvement of the effectiveness of the quality management system can be made And. 84

85 Analyze this data to provide information on: Customer satisfaction Quality Management System Conformity to product requirements Characteristics/trends of processes/products Opportunities for preventive action Suppliers 85

86 Keep Macro Level Analysis Simple UP Is good Continual improvement trend WOW Oops, spoke to soon! TIME UP Is bad Drivers of current performance What would you work on? Run Chart and Pareto 86

87 Most analytical resources belong at the process level Action DOE/Scatter PFMEA Fishbone Process mapping UP Is good Continual improvement TIME 87

88 "I I have six honest serving men They help in all I do Their names are: Where, What and When and How, Why and Who." Rudyard Kipling 88

89 The Improvement Process Understanding Continual Improvement Policy and Objectives Process Management Measurement and Data Collection Analysis of Data Measuring Results and Management Review 89

90 Management Commitment Management Review Inputs Outputs 90

91 Top management reviews the QMS Assess suitability, adequacy, effectiveness Evaluate need for change Evaluate current performance & improvement opportunities Results of reviews shall be recorded Well defined process for management review ISO 9001 & 9004 Clause

92 Management Review Inputs Outputs Careful Preparation Preparation Review Process Actions 92

93 Management Review Inputs Outputs Review inputs Required by 9001 Customer feedback/complaints Process & product performance Status of ongoing actions Changing circumstances Follow-up from past reviews Audits Improvement opportunities Review Process Ideas from 9004 Status of progress on meeting objectives Action item status Self-assessment results Benchmarking results Supplier performance Marketplace evaluations and strategies Financial effects of quality 93

94 Key Measures Sales Calls Credits & Returns Trade Shows Surveys Complaints R&D Articles Customer Ratings Get the pieces to fit together 94

95 Aggregate customer and internal data Key Measures Trade Shows R&D Sales Calls Credits & Returns Surveys Complaints Articles Customer Ratings Customer Feedback 95

96 Audit Results Process Performance Product Conformity Preventive Action Status Customer Feedback Changes Affecting System Improvement Recommendations Corrective Action Status Follow-up Actions Often managers look at the pieces 96

97 Audit Results Preventive Action Status Improvement Recommendations Process Performance Customer Feedback Corrective Action Status Product Conformity Changes Affecting System Follow-up Actions Get the overall picture! 97

98 Customer Data Product Performance Data Aligned Measures COQ Characteristic Conformance Data Priority Projects Process Data Action 98

99 Inputs Outputs Management Review Engage top managers Preparation Review Process Actions Improvement Resources 99

100 Basic Topics The Improvement Process Alignment Corrective Action and Preventive Action Actions 100

101 What action does it take to get top managers commitment? Your actions: 101

102 What action does it take to get top managers commitment? Discussion 102

103 Tactics to Achieve Alignment Align mission, vision, plans, and policy Align quality objectives to policy and business objectives Integrating systems Commitment From The Top Commitment from The Troops 103

104 Commitment from The Troops Why would you need it? Know the players people people are the way they are! Involve Train 104

105 Why do You Probably Need Commitment from Everyone? $ Millions Cost of Quality Top Ten Failure Cost Opportunities >$110,000,000 If you were the chief, what would you do? 105

106 Why do You Probably Need Commitment from Everyone? Some possibilities: Assign the top four to your senior VPs Assign a team to each of the ten Set a target to cut each of the ten in half over two years $ Millions You would likely put horsepower behind an effort to address these major opportunities Cost of Quality Top Ten Failure Cost Opportunities >$110,000,

107 Why do You Probably Need Commitment from Everyone? With a $110 million opportunity you: Are likely to act Are likely to provide senior and experienced leadership in improvement efforts Are not likely to quibble over training costs Give improvement team participation priority And you are very likely to succeed! 107

108 Why do You Probably Need Commitment from Everyone? $ Millions Cost of Quality Same Ten Failure Cost Opportunities 1999 Three Years Later $45 million of opportunity left 3 VPs for two top items? Engineers or managers for the others? If you were the chief, who would lead the teams now? 108

109 $ Thousands Why do You Probably Need Commitment from Everyone? Cost of Quality Failure Cost Opportunity #3 Causes of the Waste Progress requires tiny bites Get the workforce involved And on And on Now even our big opportunities have lots of components? 109

110 Why do You Probably Need Commitment from Everyone? Your reasons? 110

111 Why do You Probably Need Commitment from Everyone? Discussion 111

112 Why do You Probably Need Commitment from Everyone? Involvement can increase commitment to meeting the job requirements Quality Productivity Safety Etc. People feel better about their jobs Tiny problems solved may add up to big $ 112

113 Getting Commitment People Are the Way They Are The Inhibitors The Innovators The Conservatives Attitude Toward Improvement 113

114 The Dichotomy Need to: Encourage the innovators Discourage the inhibitors Treat everybody Fairly Consistently 114

115 The People Side of Quality Engagement Brains not just hands Less supervision More leadership Self-directed teams Involvement Improving your own job Improving the process Working together Cross-functional teams Empowerment Provide needed data Decisions at lowest level Alignment of objectives Organizational Personal Working environment 115

116 Involve all Members of the Organization Several implications: Boundary management Sharing with the lower levels Middle management fear 116

117 Involve all Members of the Organization Several implications: Boundary management Providing resources to do and improve job Employees sometimes handle the whole business inside their boundaries Supporting decisions made at lower levels Sharing with the lower levels Middle management fear 117

118 Command and Control vs. Commitment Models Think Control Activities Do Top management Middle management Workers Plan Measure Boundary Management Think Do Improve Traditional Command and Control Model Commitment Model 118

119 Involve all Members of the Organization Several implications: Boundary management Sharing with the lower levels Power Information Decision making Rewards for success Consequences of failure Middle management fear 119

120 Involve all Members of the Organization Several implications: Boundary management Sharing with the lower levels Middle management fear Empowerment the the dreaded E word Loss of prestige Job loss From giving orders to leading people 120

121 Evolution Of Employee Participation in Improvement Traditional Organization Task Forces Employee Involvement Teams Self Managed Workgroups Managers Solve Problems Employees Help Identify and Solve Problems Problems Solving Part of Employees Jobs 121

122 Evolution Of Employee Participation in Improvement Traditional Organization Self Managed Workgroups Managers Solve Problems Employees Help Identify and Solve Problems Problems Solving Part of Employees Jobs 122

123 5 Minute Buzz Groups Evolution Of Employee Participation in Improvement Form groups (of 2 to 5) Select a reporter for your group Where do you want/need to be on the scale? Where are you now? What do you need to do to get where you want/need to be?

124 Employee involvement in improvement buzz groups Discussion 124

125 Basic Topics The Improvement Process Alignment Corrective Action and Preventive Action Actions 125

126 Change Your Thinking on Corrective Action and Preventive Action 126

127 Corrective Action and Preventive Action Two very different concepts and their use for performance improvement requires different tools and tactics for each YES: Stop Grouping the two Together, stop calling them CAPA! 127

128 Effective Corrective Actions ISO 9004:2000 Clause Clearly understand what Corrective Action really is and is not: It is correcting causes It involves nonconformities that have happened It is not correction of nonconforming items 128

129 Effective Corrective Actions When you think of corrective action: Think of PROBLEM SOLVING Think of problem solving tools Corrective action is a tool for improvement 129

130 Effective Corrective Actions Integrate corrective action, team problem solving and other tactics 130

131 3 Minute Buzz Groups Focus Corrective Action on Solving Problems and Improvement Form groups (of 2 to 5) Select a reporter for your group What has been your thinking on Corrective action? How will you change your thinking?

132 Effective Preventive Actions ISO 9004:2000 Clause Clearly understand what Preventive Action really is and is not: It is action to prevent future nonconformities and problems It addresses things that have not happened It is not correcting the cause of existing problems 132

133 Effective Preventive Actions When you think of preventive action: Think about loss prevention Use FMEA and other loss prevention tools 133

134 Effective Preventive Actions Use preventive action during up-front activities: New products New processes New equipment Keep it separate from corrective action 134

135 Product design and development ISO 9004:2000 Clause 7.3 You may have no greater opportunity to improve your products and processes! 135

136 Apply Clause 7.3 to processes as well as products! 136

137 Clear, Two-way Communications Between Customer and Designer Identify Customer Needs Input to Design Design Needs are turned into requirements (specification) 137

138 Identify Customer Needs Input to Design Design Design Output A basic design process Purpose: Develop a design output that meets customer requirements, needs, and wants. 138

139 Verify Identify Customer Needs Input to Design Design Design Output Incremental, Synergistic Design Review Validate 139

140 Use Appropriate Tools ISO 9004:2000 Clause Failure Modes and Effects analysis FMEA Fault tree analysis Reliability prediction Relationship diagrams Ranking techniques Simulation techniques Many find FMEA the most powerful of these tools for preventing problems. 140

141 Failure Mode and Effects Analysis Technique for studying the causes and effects of failures before they occur Two common variations of FMEA: product FMEA and process FMEA May include also the criticality of potential failure modes (FMECA) Care must be taken to control the scope of the FMEA, while retaining its integrity 141

142 Failure Mode and Effects Analysis For more information see Charles A. Cianfrani and John E. (Jack) West, Cracking the case for ISO 9001:2000 for Service, or Cracking the Case of ISO 9001:2000 for Manufacturing, Milwaukee, 2003 ASQ, pp

143 Using Failure Mode and Effects Analysis List each potential failure mode(s) ) for each potential failure Describe failure mode for each potential effect that such a failure could have Estimate (on a scale of 1 to 10 with 10 being worst) severity, probability (or frequency) of occurrence, detectability (ability to detect the potential cause and prevent the failure) Multiply rankings to give a risk priority number (RPN) RPN is used to prioritize preventive actions 143

144 PART/ PROCESS Driver Truck Equipment Supplies FUNCTION OF PART/PROCESS Find stranded motorists within 1 hour Full towing capability Meters, hand tools, air compressor Gas, lug nuts Example New 24 hour road service* POTENTIA L FAILURE MODE cannot find motorist Equipment failure Air compressor or test equipment malfunction No gas on truck; no spare fuses; no aspirin EFFECT Irate customer Cannot tow car Cannot repair flat tire Cannot solve problem CAUSE(S) OF POTENTIA L FAILURE No maps or GPS; poor operator training Failure of hydraulics or mechanical systems No PM; no periodic checks Operator does not check before each call S E V E R I T Y PR OB. OF OC CU RR EN CE D E T E C T A B I L I T Y RISK PRIO RITY *See Cracking the case for ISO 9001:2000 for Service ACTION TO BE TAKEN Provide maps, GPS and computer with map program Preventive maintenance schedule Individual thro away air canisters; equipment checklist Prepare a checklist for use at beginning of every call 144

145 Verify Identify Customer Needs Input to Design Design Design Output FMEA FMEA Follow-up Validate 145

146 Integrate with design phases Understand phases of the design process Integrate controls by phase Review & FMEA Verification Validation Manage design release Manage design changes Prudent preventive action beats fixing failures! 146

147 3 Minute Buzz Groups Focus Preventive Action on Loss Prevention and Improvement Form groups (of 2 to 5) Select a reporter for your group What has been your thinking on Preventive action? How will you change your thinking?

148 Basic Topics The Improvement Process Alignment Corrective Action and Preventive Action Actions 148

149 Culture The integrated pattern of human knowledge, belief, and behavior that depends upon man s s capacity for learning and transmitting knowledge to succeeding generations Merriam Webster 149

150 Start to change behaviors Changing organizational culture takes a lot Effort Understanding Vision Time Start by Articulating the beliefs of the organization (principles) Changing behavior that can be controlled Modeling the expected new behaviors 150

151 What action can we take? Get top managers engaged use the principles Develop your own! Work on alignment Customer Objectives Objectives Process People share information engage engage train Develop a set of key driver measures Develop a means to drive improvement Use customer feedback data Use COQ Become a master at process management for improvement train train others model the behavior 151

152 Learn from others! If I have seen farther, It is by standing on the shoulders of giants Isaac Newton 152

153 Actions Planning for actions to be taken 153

154 Exercise Pick a leader and recorder for your group Spend 5 minutes individually to answer the following: What are the important opportunities you see to use your QMS to improve business performance? What actions will you take? Consolidate your group s s answers Report out 154

155 Summary The Improvement Process Alignment Objectives, measures, people Corrective action and Preventive action Change the way you think Actions 155

156 Thanks for your attention! ANY MORE QUESTIONS? 156