Quality, Speed, Price: Now Pick Three

Transcription

1 Quality, Speed, Price: Now Pick Three Implementing Lean Principles is Easier with Advanced Metrology! We believe in using technology to make better parts/products faster with lower cost and higher confidence.

2 Situation FDA & EU regulation Supply chain validation & verification Domestic & international recalls If you snooze, you lose Innovation wins 2

3 Introduction Jet Engine Engineers Pratt & Whitney GD&T professionals Metallurgical engineers Over 12 years experience Structured Light Metrology Computer Aided Inspection Cross-industry precision process expertise Regulatory affairs & QSR s 3

4 Master Practitioners Computer Aided Inspection (CAI) from 3D Structured Light Metrology (SLM) Dimensional inspection, FAI, CAD/BP comparison, analysis, part-fit, tooling Problem Solving Accelerate manufacturing process optimization Product Modernization 4

5 The Triple Constraint Problem A traditional canon of project management Fast delivery of top-quality product is expensive Cost-cutting has unfavorable consequences either harms quality or slows delivery 5

6 The Triple Constraint Problem Cost driver in medical device development: Time-to-Market (TTM) Driven by economics Mitigated by technological advance Now possible to optimize all three 6

7 The Solution: Structured Light Metrology 21 st Century Structured Light Metrology (SLM) Closer QSR Compliance Shorter Development Cycle Improved quality* Faster launch* Lower cost* *All while increasing confidence! 7

8 What Is Structured Light Metrology (SLM)? SLM is an optical 3D geometric measuring system Based on the principle of triangulation Projected structured light fringe pattern Digital cameras capture high-resolution images 3D coordinates for each pixel are recorded 4 to 11 million data points per scan Multi-scans merged to 1 complete 3D image Comprehensive post-processing of scan-files 8

9 3D Scan Captures 100% of Part s Surface Geometry in an.stl file Broach 3D Scan Stem 3D Scan 9

10 Part Scan Files Are Quickly Aligned & Compared to CAD & BP Plus Material Within Tolerance Minus Material Broach Stem 10

11 Graphic Visualization for Quick Review & Confident Conclusions Stem Insert 11

12 Vastly Superior Understanding enhancing & complimenting Conventional Dimensional Inspection Reports Stem Assembly 12

13 Comprehensive Inspection Results with speed & accuracy Inspection: Compare part to CAD Validation: Compare part to another part Surface profile of articulating Tooling acceptance & optimization Part wear pattern inspection Assemblies & part fit resolution Product Modernization (reverse engineering) Create parametric CAD models from/for legacy parts Optimize processes quickly & Reduce Time To Market 13

14 Throughout Product Life Cycle Sample applications: Investment casting Precision machining Injection molding Forge tooling Tooling inspection & digital archiving First article inspections Periodic inspections CNC program validation Assemblies part fit among many others 14

15 CAI Solution: Bone Ingrowth Coating Thickness Uniformity Cross-sections Roughness 15

16 Solution For: Temp/Press Mold Optimization & Poly-wear Reduce iterations Improve understanding & confidence Better fit to reduce wear 16

17 Accuracy Superior to CMM standard Proven by ANOVA Gauge R&R - (MSA) Accuracy better than 2.0µm ( ) overall Standard deviation 0.30µm ( ) Routine System Calibration NIST Traceable Artifacts AAAM Artifacts Perfect Correlation to Traditional Measurement Systems 17

18 Gage R&R Study Conclusion 18

19 How CAI Improves Quality DMAIC: Define Measure Analyze Improve Control Identify the problem clearly Quantify the shortfall Determine the root cause Communicate it effectively Gain process understanding Drive throughout every stage 19

20 How CAI Improves Quality DMAIC: Define Measure Analyze Improve Control CAI: The Process Engineer s Dream Tool Comprehensive information If you can see it, you can measure it Non-contact, non-destructive Fast & simple setup results in just minutes Better quality (than CMM s) at lower cost Full documentation for traceability QMS-compliant controls Can be certified to AAAM standards NIST & PTB traceable Solve your most vexing/expensive problems 20

21 How CAI Improves Quality DMAIC: Define Measure Analyze Improve Control Post-processing analysis yields comprehensive inspection results Strong evidence of problem root cause in process Full color 3D dynamic visualizations allow engineers to understand entire geometry L3I has developed a proprietary, comprehensive analysis toolset based on years of aerospace & orthopedic experience 21

22 How SLM Improves Quality DMAIC: Define Measure Analyze Improve Control Evaluate process performance against new process benchmarks Understand assembly wear characteristics Understand manufacturing outcomes Progress can be readily reported to/monitored by regulators & stakeholders Determine where improvement is most needed Modify or re-design process as needed 22

23 How CAI Improves Quality DMAIC: Define Measure Analyze Improve Control Continuous improvement Eliminate wasteful, repetitious iterations Trend insights into the control phase Drive measurement outcomes into better process understanding Make excellence a habit! 23

24 Is this a souped-up CMM? NO! CMM s no longer the gold standard CMM s fool you; Optical Comparators lie CMM s require big assumptions CAI is non-contact, fully automated, & repeatable 24

25 CAI: Superior to Traditional Metrology Objective standard of measurement Comprehensive full 3D Millions of data points to accurately compare entire geometry Improved comprehension Greater confidence Traceable, trackable, trendable for SPC No precision fixturing needed 25

26 SLM: CMM Perfect Correlation Shoulder Dome 26

27 How CAI Reduces Cost Reduce or eliminate iterations Based on 10,000-times more information Advanced metrology has lower labor costs The real story is opportunity cost Time is a lot of money Every extra month s delay cost $2-25M In lost revenue, lost profit, lost market share 27

28 The Time-to-Market Advantage Traceability Trendability Trackability Statistical Process Control (SPC) Improved Understanding of Design, Development & Process Better, Faster, Cheaper Outcomes 28

29 Automated 21 st Century CAI Smart Inspection Station Accurate & Comprehensive FAST and easy Self-contained (single plug) Configurable Shop floor ready Part scan in minutes Analysis results in seconds 29

30 What Our Clients Are Saying "Relative to the results L3I is providing, the current CMM and optical comparator are only a small improvement over guesswork. K.J., Mfg. Engineer, Orthopaedic OEM Studies have proved that the Level 3 Inspections system and method of inspection for implants is as accurate, or better than our CMMs. Since the white light scanning processes have the required accuracy and can cover so much more of the feature surface, their data is a more accurate representation of the feature true size and form. I.H., Metrology Director, Orthopaedic OEM 30

31 Keep the Competitive Edge 1. Maintain high standards Build quality in 2. Design & manufacture devices that are Lighter More reliable, longer life Less expensive Easier to use 3. Bring innovations to markets sooner 31

32 The New Triple Constraint Model Pick All Three with 21 st Century Computer Aided Inspection We are here to help you with technology to make better parts/products faster with lower cost and higher confidence. 32