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![Design of Experiment
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- 1. OVERVIEW OF SIX SIGMA(6σ) FOR PROCESS IMPROVEMENT Presented by: Larry Bartkus of Biosense Webster and Matthew Thompson of FCI Management Solutions
- 2. Goals Introduction toSix Sigma – Description – Philosophies – Benefits – Origin – Myths Identify the five steps of DMAIC, the core of Six Sigma, and the logical flow from step to step. List tools and concepts useful in each step. Brief introduction to DMADV
- 3. Six Sigma Description – “…Six Sigma is a quality program that, when all is said and done , improves your customer’s experience, lowers your costs, and builds better leaders.” Jack Welch CEO GE – Six Sigma is a proven set of tools and tactics used for process improvement, reduction of defects, and improved quality – Six Sigma uses data and statistical analysis to zero in on root causes – Six Sigma can be applied to any process
- 4. 2 3 4 5 6 σ Defects per Million opportunities 308,537 66,807 6,210 233 3.4 . 3σto 6σ - 20,000 Times Improvement ... A True QFL Six Sigma Measurement Six Sigma: What Does it Mean 30% 6% .6% 3.8 10,724 1% 2.5 158,686 16%
- 5. 99.99966% Good (6Sigma) •20,000 lost articles of mail per hour •5,000 incorrect surgical operations per week •Two short or long landings at most major airports each day •200,000 wrong drug prescriptions each year •Seven articles lost per hour •1.7 incorrect operations per week •One short or long landing every five years •68 wrong prescriptions per year 99% Good (3.8 Sigma) Six Sigma Performance Most Businesses Operate at about 3.5 Sigma
- 6. Six Sigma Philosophies – Whendefects occur look to the process for the cause. – Excellent processes will allow average people to consistently generate superior results. Benefits – More loyal and satisfied customers (internal and external) – Financial savings through improved efficiency and effectiveness – Resolution of chronic problems Origin – The late Bill Smith, a reliability engineer at Motorola, is widely credited with originating Six Sigma and selling it to Motorola's legendary CEO, Robert Galvin. Myths
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- 8. Overview of theDMAIC Method IMPROVE CONTROL MEASURE ANALYZE 5 2 3 4 DEFINE 1
- 9. Phase 1: Define Goal Define the project’s purpose and scope and get background on the process and customer Output A clear statement of the intended improvement and how it is to be measured A high-level map of the process A list of what is important to the customer IMPROVE CONTROL MEASURE ANALYZE 5 1 2 3 4 DEFINE
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- 11. Define Measure Analyze Improve/ Innovate Control ProductFlow SIPOC Process OutputInput CustomerSupplier Planning Level Build Plan Doctors Quality Engineering JCIT Capacity Requirements Line Design Compliance Issues Consulting Improved Cycle Times /WIP Reductions Reduced QNC’s Improved Efficiency/ Improved Compliance Shareholders Quality Regulatory Receive Finished Goods Trigger Cut Work Order to Line Sequence WO's Through Single Prod. Line Marketing Forecast Sterilize Release Product to Finished Goods EXISTING PROCESS FLOW
- 12. Define Measure Analyze Improve/ Innovate Control VOICEOF THE CUSTOMER Input from floor associates Why Not Campaign Identify “hidden” non-compliance issues Floor associate “buy-in” to improving the process Ease of use Documentation “mirrors” process Operations Rapid Improvement Improved Product Build Documentation Consistency between documents Compliance to procedures Reduce QNC’s Eliminate product mix-ups Simplified Product Flow Mitigate opportunity for “near miss” events Create simplified process flow. Reduce process related QNC’s by 50% Reduce near miss events from 14 in 2004 to 4 (1 per quarter) in 2005 Reduce near miss events from 14 in 2004 to 4 (1 per quarter) in 2005
- 13. Phase 2: Measure Goal Focus the improvement effort by gathering information on the current situation Output Data that pinpoints problem location or occurrence Baseline data on current process sigma A more focused problem statement IMPROVE CONTROL MEASURE ANALYZE 5 2 3 4 DEFINE 1
- 14. D M AI C • The system to collect information is already established. • 100% of Scrap forms from Work Orders for all products are captured into a Yield Database. • Scrap form (FORM633) has information as Lot Number, Date, Shift, Product Number, Defect Code, Defect Description, Potential Cause, Work Station ID, Catheter Number, Scrap Quantity, and is signed by operator and supervisor / engineer. • Yield Database has information as Product Number, Date, Lot Number, Description, Lot Quantity, Reworks, Scrap in Line, and Scrap in QA.
- 15. Documentation Time Study Analyze Minutesper Work Order Maximum = 26.5 min per W/O 8 3 2.5 2.5 2.5 2 2 2 2 0 1 2 3 4 5 6 7 8 9 Form 046 Form 335 Form 618 Form 621 Form 617 Form 615 Form 633 Form 616 Form 051 Form LenthoftimeinMinutes
- 16. Burst Tester GageR&R AnalyzeMeasure Improve ControlDefine Percent Part-to-PartReprodRepeatGage R&R 100 50 0 % Contribution % Study Var SampleStDev 6 4 2 _ S=3.447 UCL=5.418 LCL=1.476 Operator 1 Operator 2 SampleMean 100 80 60 __ X=86.10 Operator 1 Operator 2 UCL=88.81 LCL=83.38 Operators Settings Operator 2Operator 1 NominalMinimumNominalMinimum 100 75 50 Operators Operator 2Operator 1 100 75 50 Gage name: Gage R&R for Burst V alues (U niv ersal Tray ) Date of study : Reported by : J. C han Tolerance: M isc: Components of Variation S Chart by Operators Xbar Chart by Operators Burst By Settings ( Operators ) Burst by Operators Gage R&R (Nested) for Burst Values The total Gage Repeatability and Reproducibility is 12.38%, which is well below the acceptance criteria of less than or equal to 30% of the Total Variation. Measurement system is acceptable. The Gage R & R study is able to show that the burst tester is capable of detecting different parts being measured as shown from the data reported by two different operators measuring the samples.
- 17. Process Capability-Current IndividualValue 4321 1.8 1.6 1.4 _ X=1.5955 UCL=1.9437 LCL=1.2472 MovingRange 4321 0.4 0.2 0.0 __ MR=0.1309 UCL=0.4278 LCL=0 Observation Values 4321 1.68 1.60 1.52 1.81.71.61.51.41.31.2 LSL Specifications LSL 1.13 2.11.81.51.2 Within Ov erall Specs Within StDev 0.116076 C p * C pk 1.34 O v erall StDev 0.102049 Pp * Ppk 1.52 C pm * Process Capability Sixpack of C before I Chart Moving Range Chart Last 4 Observations Capability Histogram Normal Prob Plot A D: 0.350, P: 0.255 Capability Plot
- 18. Process Capability Ring20 – Current Marking Method 0 1 2 3 4 5 6 7 8 9 10 169.70 169.95 170.20 170.45 Xbar and R Chart Subgr Mean Mean=170.1 UCL=170.4 LCL=169.7 0.0 0.3 0.6 0.9 Range R=0.3515 UCL=0.9050 LCL=0 0 1 2 3 4 5 6 7 8 9 10 Last 10 Subgroups 169.8 170.0 170.2 170.4 Subgroup Number Values 169.5 170.5 Capability Plot Process Tolerance I I I I I I I I Specifications Within Overall 169.5 170.0 170.5 Normal Prob Plot 169.6 170.0 170.4 Capability Histogram Within StDev: Cp: Cpk: 0.207647 0.80 0.70 Overall StDev: Pp: Ppk: 0.191131 0.87 0.76 Process Capability Sixpack for Prod. Ring20 DMAI2 C
- 19. Phase 3: Analyze Goal Identify deep root causes and confirm them with data Output A theory that has been tested and confirmed IMPROVE CONTROL MEASURE ANALYZE 5 2 3 4 DEFINE 1
- 20. D M AI C D-1237-02-SD-1237-01-S 1.34 1.32 1.30 1.28 1.26 1.24 1.22 1.20 1.18 1.16 PART NUMBER AverageperWO 1 2 Multi-Vari Chart for Short in Ring Shif t D-1237-01-S D-1237-02-S 1.00 1.05 1.10 1.15 1.20 1.25 1.30 1.35 PART NUMBERAverageperWO 1 2 Multi-Vari Chart for No Reading Shif t D-1237-01-S D-1237-02-S 0.98 1.08 1.18 1.28 1.38 1.48 1.58 1.68 1.78 PART NUMBER AverageperWO 1 2 Multi-Vari Chart for Lasso out of Roundness Shif t D-1237-02-SD-1237-01-S 1.35 1.30 1.25 1.20 1.15 1.10 1.05 1.00 PART NUMBER AverageperWO 1 2 Multi-Vari Chart for Damaged Ring Shif t D-1237-01-S D-1237-02-S 1.00 1.05 1.10 1.15 1.20 1.25 1.30 1.35 PART NUMBER AverageperWO 1 2 Multi-Vari Chart for Damaged Spine Cover Shif t D-1237-01-S D-1237-02-S 1.0 1.1 1.2 1.3 PART NUMBER AverageperWO 1 2 Multi-Vari Chart for Tip going Backwards Shif t
- 21. Benchmarking - Internal StrategicAdvantage •AdvancedApplications •High Interactivity e.g. online forms •Knowledge Mgt hub •Primary Communications Vehicle •Content Rich Tier 4 Transforming Features Tier 1 Basic Presence Basic Company Information Tier 3 Integrating •Communities •Advanced Search •Value-add tools •Moderate Interactivity •Personalisation •Extensive information •Basic Search Tier 2 Searching Analyze
- 22. Regression Analysis Analyze Forecasted Demand 08/15/05-07/15/05 Month GrandTotal 121086420 40000 39000 38000 37000 36000 35000 34000 33000 32000 31000 S 2661.11 R-Sq 7.0% R-Sq(adj) 0.0% Fitted Line Plot Grand Total = 34329 + 193.1 Month 7% Increase in demand/year
- 23. Design of Experiment AnalyzeMeasureImprove ControlDefine 23 Factorial Design Factors Low High Temperature 245 F 260 F Pressure 55 PSI 90 PSI Time 2 SEC 3 SEC
- 24. Design of Experiment AnalyzeMeasureImprove ControlDefine Hi Lo0.00000 D New Cur d = 0.00000 Maximum Burst Va y = 94.6429 2.0 3.0 55.0 90.0 245.0 260.0 Pressure TimeTemp [245.0] [75.0] [3.0]
- 25. Phase 4: Improve Goal Develop, pilot, and implement solutions that address root causes. Output Identification of planned, tested actions that should eliminate or reduce the impact of the identified root causes CONTROL MEASURE ANALYZE 5 2 3 DEFINE 1 FMEA IMPROVE 4
- 26. D M AI C •Improvement team created with members of Quality, Production, Engineering and R&D areas to propose and evaluate ideas. •Brainstorming tool was used to gather ideas on how to solve the problems identified. •Ideas were evaluated per following criteria: feasible, high impact, easy, low cost, and quick. •Following tables summarizes solutions agreed by consensus of the improvement team.
- 27. D M AI C PROBLEM BRIEF DESCRIPTION PROPOSED SOLUTION Some acceptance criteria are not clear for associates. Rejection of good product exposes it to damage during rework operations. Train associates on visual acceptance criteria. Lasso to tip method. Defective bonding of Compression Coil and Lasso Stem PU is applied before the components are in place and is partially removed during installation of components. Add a new hole to apply PU to bond components once they are in place. Prep. lasso stem method. Poor burnishing of Nitinol wire. Current burnishing method is not ergonomic causing associates make defects after some time. Design a new fixture to hold Nitinol during burnishing.
- 28. Solutions FMEA Pilot Im plem en- tation Solutions FMEA Pilot Im plem en- tation RISK 12. SupportPlan not in Place Description IntegWare does not want to put Biosense Webster in a position of being overly reliant for day-to-day level 1 support of the system after go-live. IntegWare typically suggests that we assume the role of a second level support for a limited number of hours per month. IntegWare suggests it is typical for Day-to-Day (level 1) support will be a highly resource consuming task for three-six months after go- live. To use IntegWare for this might be an ineffective usage of the customer's resources. The project ownership should be transferred to the customer if at all possible. It would be a better usage of the customer’s resources to ask IntegWare to implement higher value- added initiatives in PDM (such as developing PART/BOM configuration management features, JDE integration, etc.) MITIGATION To mitigate this risk, we have discussed a support concept at BWI. This will be a combo function between Doc services (they will handle basic application admin functions) and IM who will handle IT functions. Still need to setup support contract for IntegWare to support system. Celeste has added to the schedule a support contract for level 2 support from IntegWare. RISK LEVEL HIGH UPDATED 5/2/03 ASSESSING RISK An Example:
- 29. AnalyzeMeasure Improve/ ControlDefine EstimatedCost Benefit 100 10 1 CMM vs. Estimated Cost Avoidance $0 $1 $2 $3 $4 $5 1 2 3 4 5 Millions Capability Maturity Model (CMM) Level CumulativeCompliance Risk($) Cumulative Risk ($) Compliance Cost Risk reduction = $1.7 Million 1.6 2 .5
- 30. Pilot/Pilot Plan AnalyzeMeasureDefine Control UsedJapan Custom line as a pilot - Medium size production line - Minimize the production Impact – Kanbans Cards – Signals, Lights – Performance Measures Improve/
- 31. Phase 5: Control Goal Use data to evaluate both the solutions and the plans Validate that all changes adhere to all operating company change control, GMP, and compliance requirements Maintain the gains by standardizing processes Outline next steps for on-going improvement Output Before-and-After analysis Monitoring system Completed documentation of results, learnings, and recommendations IMPROVE CONTROL MEASURE ANALYZE 5 2 3 4 DEFINE 1
- 32. D M AI C •All new tooling, processes, clarifications, and visual aids documented in PIs. •Creation of MOPXXX with all the quality criteria for Variable Lasso Deflection and Contraction performance. •MOP003 updated with reference to new created MOPXXX. •PU quality criteria documented in WSS001 and available in QA workbenches.
- 33. D M AI C •Yields Chart is published every week. Work Orders Built Yield Goal Scrap Produced Yield Actual
- 34. I-MR Charts ofBurst Tester AnalyzeMeasure Improve ControlDefine Burst Values IndividualValue 302928272625242322212019181716151413121110987654321 115 110 105 100 _ X=105.88 UCL=113.76 LCL=97.99 Observation MovingRange 302928272625242322212019181716151413121110987654321 10 5 0 __ MR=2.97 UCL=9.69 LCL=0 Universal Tray Packaging (CA Sealer) In-H20 Burst Values IndividualValue 302928272625242322212019181716151413121110987654321 110 105 100 95 _ X=100.72 UCL=109.68 LCL=91.76 Observation MovingRange 302928272625242322212019181716151413121110987654321 12 8 4 0 __ MR=3.37 UCL=11.01 LCL=0 Universal Tray Packaging (Juarez Sealer) In-H20
- 35. Lessons Learned • Cultureshock • Resources • Scope creep / Identifying the critical few • Management buy-in of change of policies • Time management & deliverables challenges • J&J Goals too high for small operating company (CMM goal of Level 3 per J&J Corp Strategy) • Difficult to measure compliance
- 36. Project Closure Improvement mustbe continuous, but individual initiatives and project teams come to an end. Learn when it’s time to say goodbye. Effective project closure weaves together the themes of: – Project purpose. – Improvement methods. – Team skills and structures. Develop managerial systems to capture learnings and enable the organization to address system issues. Documentation and recognition are two critical aspects of project team closure. Celebrate!
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- 38. New product Development- DEx Roadmap - DMADV • DEFINE – Develop the Business Case, Scope & Charter the Project • MEASURE – Gather & Quantify Design Inputs (Customer, Technical, Business, Regulatory) • ANALYZE – Develop and Investigate Conceptual Designs • DESIGN – Develop Detailed Product/Service/Process Designs • VERIFY/VALIDATE – Confirm design outputs meet design input requirements and ensure specifications conform with intended uses and users; Scale-up manufacture and release the product or scale-up and implement the new process; Finally, transfer to process owners Verify/ Validate DesignAnalyzeMeasureDefine
- 39. Opportunity Define Measure Analyze Design Verify/Validate Transfer DEx Methodology IDTask Name 1ID Customers 2 ID Needs 3 ID CCRs 4 Review 5 DevelopConcepts 6 High-Level Design 7 Capability 8 DesignReview 9 DevelopDetails 10Simulation 11Cost Analysis 12DesignReview 13Procurement 14Implementation SepOctNovDecJanFebMarAprMayJunJulAugSep Qtr 4, 1999Qtr 1, 2000Qtr 2, 2000Qtr 3, 2000 Business Case Goal Statement Project Plan Opportunity Statement Project Scope Team Selection Team Charter Generation1Generation2Generation3 Vision Product/ Service Generation Technologies/ Platforms Theme 1 Need 1 Need 2 Theme 2 Need 3 Need 4 Need 5 Theme 3 Need 7 Need 8 1 Customer Requirem ents (V) 3 Characteristic/Measur es (how)(I) Target goals 7 Correlatio n (I) 2 Cust omer Rati ng (B) (V) 4 Relationships (What vs. How) (I) 6 5 Importance(V) How important Targets/Spec s(B)(I) Technical Evaluation (B) Measures (Hows) Customerneeds (Whats) House Of Quality #1 Critical processcharacteristics (Hows) Measures (Whats) House Of Quality #2 Creative Techniques White Red Black Blue Green Yellow Start With What You Know Get Other Perspec- tives Non-Linear Thinking Buildon Ideas Combine Ideas Compare FAULT TREE SYSTEM RELIABILITY PREDICTION System Failure Pump P1 Fails Pump P2 Fails Pump V1 Fails Pump V2 FailsR = RBil X (1 - (1-Rp)2) x (1 - (1-Rv)2) PumpsBilge Valves P1 P2 V1M V2M Bilge Failure Pump Failure Valve Failure Time (t) HazardRate- h(t) Random Failures Early Failures Wearou t Failures Process 2 Process 1 Process 3 Worker 1 Inspector 1 Worker 2 Inspector 2 Worker 3 Inspector 3 Recorder 3 Recorder 2 Recorder 1 Card Inspect 1 Inspect 2 Inspect 3 Card Drop Shop - Process Model Recorders Workers Inspectors Develop Process Control Plan Error Proofing and Contingency Planning Detailed Design Review Prepare Pilot Test Plans Act Plan Check Do Start Type of data ? Counting items with an attribute or counting occurrences? Equal sample sizes ? Equal opportunity ? Continuous Yes No Yes Rational Subgroups Discrete Yes No No Do limits look right? Try individuals charts Need to detect small shifts quickly? Individual measurements or subgroups ? Do limits look right? YesNo Either/Or No Yes Individual measurements Occurrences Items with attribute p chart Try transformation to make data normal no chart u chart c chart X, R or s chart Individuals charts EWMA chart Unstable (Not in control) Stable (In control) Within spec limits Upper Spec Lower Spec Upper Spec Lower Spec UCL LCL UCL LCL Outside spec limits Upper Spec Lower Spec Upper Spec Lower Spec UCL LCL UCL LCL Type of Design Products Services Design- Production- Delivery Processes Supporting Processes Type of Design Design Elements Products Services Design- Production- Delivery Processes Supporting Processes 1. HW Products 2. SW Products 3. Services 4. Analyses 5. Information Systems 6. Processes and Methods 7. Human Resources 8. Site Facilities 9. Equipment Tools 10. Materials Supplies 11. Sales Marketing 12. Other Non-Technical
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