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Data Driven Design for Manufacturability – From Validation to PPAP - OMTEC 2017

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The use of data-driven design for manufacturability is a proven method to speed time to market using GD&T and data as a common language. By reducing the number of features called out as critical, inspection times are dramatically reduced and validation is simplified—not only during the development stage, but for the lifetime of the product. Mr. Jaeck demonstrates this process from the OEM and contract manufacturer perspectives.

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Data Driven Design for Manufacturability – From Validation to PPAP - OMTEC 2017

  1. 1. Edward Jaeck V.P. of Operations Lowell Inc. Minneapolis, MN June 14, 2017 Data Driven Design for Manufacturability – From Validation to PPAP
  2. 2. 3 #1 Technical #2 Commercial #3 Regulatory This presentation will focus on three key aspects of Design for Manufacturing (DFM)
  3. 3. Executive Business Team Program Management Office Regulatory Affairs Reimbursement Legal Operations Post Market Quality 4 The Regulatory Team consists of the following:
  4. 4. Strategic Sourcing Technical Sourcing Commodity Specialists Purchasing Buyers Planners 5 The Commercial Team consists of the following:
  5. 5. R&D Clinical Design Manufacturing Quality Supplier Quality 6 The Technical Team consists of the following:
  6. 6. Quick and easy napkin sketches to show basic idea Rev 1 Drawings to work through functional relationships of features Post validation formally released drawings Technical Team: There is more to design than concept sketches 7
  7. 7. The amount of work to go from concept sketches to final drawings is not linear 8
  8. 8. Metrology Planning Review Manufacturing Review Post Processing Review 9 There are three focus areas for the Technical Team
  9. 9. 10 Success: A complete and accurate CAD model and drawing set using ASME or ISO Standard for Geometric Dimensioning and Tolerancing (GD&T) A detailed metrology planning session to review the preliminary design drawings and CAD is a must
  10. 10. Apply GD&T prior to metrology planning review 11
  11. 11. Good metrology planning reviews allow us to find the red flags in a project and fix them early Feature Type Count Feature Type Nominal Dimension Total Tolerance Resolution Required Gage Operation Gage Used - Current Gage Accuracy Resolution Check P/T Ratio Time (min) Inspection Cost Per feature 1 Diameter 0.3900 0.0050 0.00050 Automated Quest 450 OGP 0.00001 Pass 10% 2 $3.33 2 Radius 0.0030 0.0010 0.00010 Automated S-T Optical Comparitor 50x 0.0001 Pass 15% 4 $6.67 1 Radius 0.0030 0.0010 0.00010 Automated Quest 450 OGP 0.00001 Pass 24% 0.25 $0.42 2 Radius 0.0790 0.0010 0.00010 Automated Quest 450 OGP 0.00001 Pass 24% 0.25 $0.42 1 Linear 0.3500 0.0020 0.00020 Manual 8" Caliper 0.001 Fail 35% 0.5 2 Linear 0.6800 0.0020 0.00020 Manual 8" Caliper 0.001 Fail 36% 0.5 3 Linear 0.2560 0.0020 0.00020 Manual Starret Optical Comparitor 0.0001 Pass 37% 3 $5.00 Negligible 1 Linear 0.0950 0.0002 0.00002 Manual 0-1" Micrometer 0.00005 Fail 20% 2 $3.33 $0.83 Minor Major Critical Red Flag #1: Radii as critical and major, check for Profile 12
  12. 12. Good metrology planning reviews allow us to find the red flags in a project and fix them early Feature Type Count Feature Type Nominal Dimension Total Tolerance Resolution Required Gage Operation Gage Used - Current Gage Accuracy Resolution Check P/T Ratio Time (min) Inspection Cost Per feature 1 Diameter 0.3900 0.0050 0.00050 Automated Quest 450 OGP 0.00001 Pass 10% 2 $3.33 2 Radius 0.0030 0.0010 0.00010 Automated S-T Optical Comparitor 50x 0.0001 Pass 15% 4 $6.67 1 Radius 0.0030 0.0010 0.00010 Automated Quest 450 OGP 0.00001 Pass 24% 0.25 $0.42 2 Radius 0.0790 0.0010 0.00010 Automated Quest 450 OGP 0.00001 Pass 24% 0.25 $0.42 1 Linear 0.3500 0.0020 0.00020 Manual 8" Caliper 0.001 Fail 35% 0.5 2 Linear 0.6800 0.0020 0.00020 Manual 8" Caliper 0.001 Fail 36% 0.5 3 Linear 0.2560 0.0020 0.00020 Manual Starret Optical Comparitor 0.0001 Pass 37% 3 $5.00 Negligible 1 Linear 0.0950 0.0002 0.00002 Manual 0-1" Micrometer 0.00005 Fail 20% 2 $3.33 $0.83 Minor Major Critical Red Flag #2: .0002” tolerance with manual metrology 13
  13. 13. Good metrology planning reviews allow us to find the red flags in a project and fix them early Feature Type Count Feature Type Nominal Dimension Total Tolerance Resolution Required Gage Operation Gage Used - Current Gage Accuracy Resolution Check P/T Ratio Time (min) Inspection Cost Per feature 1 Diameter 0.3900 0.0050 0.00050 Automated Quest 450 OGP 0.00001 Pass 10% 2 $3.33 2 Radius 0.0030 0.0010 0.00010 Automated S-T Optical Comparitor 50x 0.0001 Pass 15% 4 $6.67 1 Radius 0.0030 0.0010 0.00010 Automated Quest 450 OGP 0.00001 Pass 24% 0.25 $0.42 2 Radius 0.0790 0.0010 0.00010 Automated Quest 450 OGP 0.00001 Pass 24% 0.25 $0.42 1 Linear 0.3500 0.0020 0.00020 Manual 8" Caliper 0.001 Fail 35% 0.5 2 Linear 0.6800 0.0020 0.00020 Manual 8" Caliper 0.001 Fail 36% 0.5 3 Linear 0.2560 0.0020 0.00020 Manual Starret Optical Comparitor 0.0001 Pass 37% 3 $5.00 Negligible 1 Linear 0.0950 0.0002 0.00002 Manual 0-1" Micrometer 0.00005 Fail 20% 2 $3.33 $0.83 Minor Major Critical Red Flag #3: 3 Minors with manual metrology 14
  14. 14. Good metrology planning reviews allow us to find the red flags in a project and fix them early Feature Type Count Feature Type Nominal Dimension Total Tolerance Resolution Required Gage Operation Gage Used - Current Gage Accuracy Resolution Check P/T Ratio Time (min) Inspection Cost Per feature 1 Diameter 0.3900 0.0050 0.00050 Automated Quest 450 OGP 0.00001 Pass 10% 2 $3.33 2 Radius 0.0030 0.0010 0.00010 Automated S-T Optical Comparitor 50x 0.0001 Pass 15% 4 $6.67 1 Radius 0.0030 0.0010 0.00010 Automated Quest 450 OGP 0.00001 Pass 24% 0.25 $0.42 2 Radius 0.0790 0.0010 0.00010 Automated Quest 450 OGP 0.00001 Pass 24% 0.25 $0.42 1 Linear 0.3500 0.0020 0.00020 Manual 8" Caliper 0.001 Fail 35% 0.5 2 Linear 0.6800 0.0020 0.00020 Manual 8" Caliper 0.001 Fail 36% 0.5 3 Linear 0.2560 0.0020 0.00020 Manual Starret Optical Comparitor 0.0001 Pass 37% 3 $5.00 Negligible 1 Linear 0.0950 0.0002 0.00002 Manual 0-1" Micrometer 0.00005 Fail 20% 2 $3.33 $0.83 Minor Major Critical Red Flag #4: 3 features failing 10:1 ratio 15
  15. 15. Good metrology planning reviews allow us to find the red flags in a project and fix them early Feature Type Count Feature Type Nominal Dimension Total Tolerance Resolution Required Gage Operation Gage Used - Current Gage Accuracy Resolution Check P/T Ratio Time (min) Inspection Cost Per feature 1 Diameter 0.3900 0.0050 0.00050 Automated Quest 450 OGP 0.00001 Pass 10% 2 $3.33 2 Radius 0.0030 0.0010 0.00010 Automated S-T Optical Comparitor 50x 0.0001 Pass 15% 4 $6.67 1 Radius 0.0030 0.0010 0.00010 Automated Quest 450 OGP 0.00001 Pass 24% 0.25 $0.42 2 Radius 0.0790 0.0010 0.00010 Automated Quest 450 OGP 0.00001 Pass 24% 0.25 $0.42 1 Linear 0.3500 0.0020 0.00020 Manual 8" Caliper 0.001 Fail 35% 0.5 2 Linear 0.6800 0.0020 0.00020 Manual 8" Caliper 0.001 Fail 36% 0.5 3 Linear 0.2560 0.0020 0.00020 Manual Starret Optical Comparitor 0.0001 Pass 37% 3 $5.00 Negligible 1 Linear 0.0950 0.0002 0.00002 Manual 0-1" Micrometer 0.00005 Fail 20% 2 $3.33 $0.83 Minor Major Critical Red Flag #5: 3 features failing % P/T req. for a basic Type 1 Rpt. study 16
  16. 16. Good metrology planning reviews allow us to find the red flags in a project and fix them early Feature Type Count Feature Type Nominal Dimension Total Tolerance Resolution Required Gage Operation Gage Used - Current Gage Accuracy Resolution Check P/T Ratio Time (min) Inspection Cost Per feature 1 Diameter 0.3900 0.0050 0.00050 Automated Quest 450 OGP 0.00001 Pass 10% 2 $3.33 2 Radius 0.0030 0.0010 0.00010 Automated S-T Optical Comparitor 50x 0.0001 Pass 15% 4 $6.67 1 Radius 0.0030 0.0010 0.00010 Automated Quest 450 OGP 0.00001 Pass 24% 0.25 $0.42 2 Radius 0.0790 0.0010 0.00010 Automated Quest 450 OGP 0.00001 Pass 24% 0.25 $0.42 1 Linear 0.3500 0.0020 0.00020 Manual 8" Caliper 0.001 Fail 35% 0.5 2 Linear 0.6800 0.0020 0.00020 Manual 8" Caliper 0.001 Fail 36% 0.5 3 Linear 0.2560 0.0020 0.00020 Manual Starret Optical Comparitor 0.0001 Pass 37% 3 $5.00 Negligible 1 Linear 0.0950 0.0002 0.00002 Manual 0-1" Micrometer 0.00005 Fail 20% 2 $3.33 $0.83 Minor Major Critical Red Flag # 6: Time 15 min and cost around $20 17
  17. 17. Good metrology planning reviews allow us to find the red flags in a project and fix them early Feature Type Count Feature Type Nominal Dimension Total Tolerance Resolution Required Gage Operation Gage Used - Current Gage Accuracy Resolution Check P/T Ratio Time (min) Inspection Cost Per feature 1 Diameter 0.3900 0.0050 0.00050 Automated Quest 450 OGP 0.00001 Pass 10% 2 $3.33 2 Radius 0.0030 0.0010 0.00010 Automated S-T Optical Comparitor 50x 0.0001 Pass 15% 4 $6.67 1 Radius 0.0030 0.0010 0.00010 Automated Quest 450 OGP 0.00001 Pass 24% 0.25 $0.42 2 Radius 0.0790 0.0010 0.00010 Automated Quest 450 OGP 0.00001 Pass 24% 0.25 $0.42 1 Linear 0.3500 0.0020 0.00020 Manual 8" Caliper 0.001 Fail 35% 0.5 2 Linear 0.6800 0.0020 0.00020 Manual 8" Caliper 0.001 Fail 36% 0.5 3 Linear 0.2560 0.0020 0.00020 Manual Starret Optical Comparitor 0.0001 Pass 37% 3 $5.00 Negligible 1 Linear 0.0950 0.0002 0.00002 Manual 0-1" Micrometer 0.00005 Fail 20% 2 $3.33 $0.83 Minor Major Critical Red Flag #1: Radii as critical and major, check for Profile Red Flag #2: .0002” tolerance with manual metrology Red Flag #3: 3 Minors with manual metrology Red Flag #4: 3 features failing 10:1 ratio Red Flag #5: 3 features failing % P/T req. for a basic Type 1 Rpt. study Red Flag # 6: Time 15 min and cost around $20 18
  18. 18. The metrology planning review led to three key concerns 1. The .003” radii need profile tolerancing 2. 15 minute measurement time will drive cost later 3. Initial Type 1 Repeatability studies not promising 19
  19. 19. Metrology Planning Review Manufacturing Review Post Processing Review 20 There are three focus areas for the Technical Team
  20. 20. If manufacturers have flagged a client’s critical features, the project is in trouble Each supplier defines their own key MFG risk categories 21 Balloon # Feature Description Machine Axis/Axes used to create feature Nom Dim Plus Tolerance Minus Tolerance Total Tolerance Feature Type MFG Risk 1 MFG Risk 2 MFG Risk 3 Customer Risk Assessment 1 0.350 EDM (X,Y,W) 0.350 0.001 0.001 0.0020 Linear Low Low Low Minor 2 0.095 EDM (X,Y,W) 0.095 0.001 0.001 0.0020 Linear Low Low Low Negligible 3 0.680 EDM (X,Y,W) 0.680 0.001 0.001 0.0020 Linear Low Low Low Minor 4 0.256 EDM (X,Y,W) / Milling (X,Y,Z) 0.256 0.001 0.001 0.0020 Linear Medium Low Medium Minor 5 .001 A B (J-K) EDM (X,Y,W) 0.001 0.001 0.001 0.0010 Profile High Medium Medium Critical 6 .001 A B (F- G) EDM (X,Y,W) 0.001 0.001 0.001 0.0010 Profile High Low Medium Critical 7 0.362 Milling (X,Y,Z) 0.362 0.001 0.001 0.0020 Diametric Medium Medium Medium Negligible 8 4x R.005 Max EDM (X,Y,W) 0.005 0.000 0.005 0.0050 Radial Low Low Low Negligible 9 2X .108 EDM (X,Y,W) 0.108 0.001 0.001 0.0020 Linear Low Low Low Negligible 10 2x .066 EDM (X,Y,W) 0.066 0.001 0.001 0.0020 Linear Low Low Low Negligible 11 0.390 EDM (X,Y,W) / Milling (X,Y,Z) 0.390 0.001 0.001 0.0020 Diametric Medium Low Medium Critical
  21. 21. The manufacturing review led to two key concerns 1. The intricate features in Detail B need to be grouped and toleranced with profile 22 2. The small radii in Detail C can be grouped and toleranced with profile, possibly minimizing risk
  22. 22. Metrology Planning Review Manufacturing Review Post Processing Review (Color Anodizing) 23 There are three focus areas for the Technical Team
  23. 23. Some “interference” colors are challenging to make • Color choice drives cost. Purple and Seafoam have ~ +/- 1V range and thus higher cost • * Images used with permission from American Bright Works in Fridley, MN • http://americanbrightworks.com 24
  24. 24. Surface cleanliness is important in color anodizing Remove oils & contamination on surfaces & in deep nooks 25
  25. 25. Chemical deburring is helpful before color anodizing • Run cost model with and without deburring • Adjust tolerances for chemical deburring 26
  26. 26. Masking parts is manual and adds cost Parts requiring individual masking – whether they are single color or multi-color increases handling charges, time to process and therefore cost ~10-15% adder. 27
  27. 27. Color anodizing the entire component minimizes cost Simplified design with no masking or blind holes 28
  28. 28. The post processing review led to two key concerns 29 1. A cleaning step needs to be added to the process flow to ensure removal of surface oils 2. The part will remain one color to minimize cost
  29. 29. Cost Modeling 30 There is one focus for the Commercial Team
  30. 30. 31 Commercial Team: It only takes one excitement feature to make a commodity component a specialty component.
  31. 31. With specialty components, the commercial team should focus on cost-modeling of the process 32
  32. 32. Build the simple should-cost model first… 33 Process Step Dist Type Mean Time Per Unit in Mins Lower Upper Stdev $/hour $/min Price/unit with Milling Ti-6Al-4V ELI raw material cost Normal 5.00 5 0.5 N/A N/A 5.00$ Verify Incoming Raw Material Uniform 15.00 10 20 $ 75 1.25$ 18.75$ Saw Uniform 7.50 5 10 $ 75 1.25$ 9.38$ Mill Uniform 8.00 6 10 $ 100 1.67$ 13.33$ EDM normal 7.00 7 1 $ 100 1.67$ 11.67$ Dim Inspection Uniform 15.00 10 20 $ 100 1.67$ 25.00$ OSP Uniform 10.00 8 12 $ 75 1.25$ 12.50$ Final Inspection Uniform 14.00 8 20 $ 100 1.67$ 23.33$ 118.96$ $/Hour numbers are simple placeholders
  33. 33. Build the simple should-cost model first… Should-Cost model ~ Process Flow + Activity-Based Costing Step 1: Build basic deterministic model in Excel Step 2: Add variation to the model by replacing static point estimates with stochastic functions. Use historical data and process knowledge to pick distributions Step 3: Run the Monte Carlo simulation and check the mean and range assumptions Step 4: Run and review the sensitivity analysis to find key cost drivers34 Process Step Dist Type Mean Time Per Unit in Mins Lower Upper Stdev $/hour $/min Price/unit with Milling Ti-6Al-4V ELI raw material cost Normal 5.00 5 0.5 N/A N/A 5.00$ Verify Incoming Raw Material Uniform 15.00 10 20 $ 75 1.25$ 18.75$ Saw Uniform 7.50 5 10 $ 75 1.25$ 9.38$ Mill Uniform 8.00 6 10 $ 100 1.67$ 13.33$ EDM normal 7.00 7 1 $ 100 1.67$ 11.67$ Dim Inspection Uniform 15.00 10 20 $ 100 1.67$ 25.00$ OSP Uniform 10.00 8 12 $ 75 1.25$ 12.50$ Final Inspection Uniform 14.00 8 20 $ 100 1.67$ 23.33$ 118.96$ $/Hour numbers are simple placeholders
  34. 34. In step 3, run the simulation and check the mean value assumptions Output for cost appears normal which should be assumed based on central limit theorem, with a mean value ~$119 35
  35. 35. In step 3, run the simulation and check the range assumptions If you were the supplier, which cost would you provide to the customer without any historical data? 36
  36. 36. In step 4, run the sensitivity analysis to find the key cost drivers Inspection costs are the key cost drivers at this point, work with the technical team to learn more about ways to drive costs down. 37
  37. 37. Fix root causes of the variation in inspection steps Start with conservative distribution assumptions and tighten them based on data 38
  38. 38. Seek to combine processing steps if ideal Warning: Combining process steps is not always ideal. Base the decision on data. 39
  39. 39. Review what features are created with milling 40 Balloon # Feature Description Machine Axis/Axes used to create feature Nom Dim Plus Tolerance Minus Tolerance Total Tolerance Feature Type 1 0.350 EDM (X,Y,W) 0.350 0.001 0.001 0.0020 Linear 2 0.095 EDM (X,Y,W) 0.095 0.001 0.001 0.0020 Linear 3 0.680 EDM (X,Y,W) 0.680 0.001 0.001 0.0020 Linear 4 0.256 EDM (X,Y,W) / Milling (X,Y,Z) 0.256 0.001 0.001 0.0020 Linear 5 .001 A B (J-K) EDM (X,Y,W) 0.001 0.001 0.001 0.0010 Profile 6 .001 A B (F- G) EDM (X,Y,W) 0.001 0.001 0.001 0.0010 Profile 7 0.362 Milling (X,Y,Z) 0.362 0.001 0.001 0.0020 Diametric 8 4x R.005 Max EDM (X,Y,W) 0.005 0.000 0.005 0.0050 Radial 9 2X .108 EDM (X,Y,W) 0.108 0.001 0.001 0.0020 Linear 10 2x .066 EDM (X,Y,W) 0.066 0.001 0.001 0.0020 Linear 11 0.390 EDM (X,Y,W) / Milling (X,Y,Z) 0.390 0.001 0.001 0.0020 Diametric
  40. 40. 41 The right graph in the right software is crucial Combining milling and EDM steps increases mean cost by ~ $8.30
  41. 41. The commercial review led to two key concerns 1. Inspections costs are the key cost drivers 42 2. Combining milling and EDM is not cost effective
  42. 42. Minimize complexity 43 There is one focus for the Regulatory Team
  43. 43. Commercial Team at Impasse HereTechnical Team Lost Here Regulatory Team driving from the center or Technical, Commercial and Regulatory Teams moving efficiently through the maze together 44 Regulatory Team: The regulatory agencies give the requirements but the complexity is controlled by the regulatory team
  44. 44. Always think about the validation complexity Note: Drawings stay preliminary until post validation 45
  45. 45. 46 When it comes to validation planning, define the ends of the goalpost first, then work in from there All features are critical No features are critical
  46. 46. 47 Proactively define the feature risk classifications Minimize A/B where: A= the number of critical features B = the number of negligible features
  47. 47. 48 To establish the validation cost baseline, assume no features are critical No features are critical Total OQ Costs $15,485 Total PQ Costs $15,485 Total Validation Costs $30,970
  48. 48. 49 To see how complex the validation can get, next assume all features are critical All features are critical
  49. 49. Total OQ Costs $17,485 Total PQ Costs $17,485 Total Validation Costs $34,970 Driving design to two critical features saves money while balancing validation risk 50
  50. 50. The regulatory review led to four concerns 1. Feature risk classification modulates sample size and cost 2. Use of profile on feature 6 moves it from critical to negligible 3. Using 2 critical features balanced risk and validation cost 4. Feature risk classification ratio = 2/6 or 33% not ideal 51 Balloon # Feature Description Feature Risk 1 0.350 Minor 2 0.095 Negligible 3 0.680 Minor 4 0.256 Minor 5 .001 A B (J-K) Critical 6 .001 A B (F-G) Negligible 7 0.362 Negligible 8 4x R.005 Max Negligible 9 2X .108 Negligible 10 2x .066 Negligible 11 0.390 Critical
  51. 51. 52 #1 Technical Metrology Review Manufacturing Review Post Processing Review #2 Commercial Process Mapping Should-Cost Modeling Monte-Carlo Simulation #3 Regulatory Product/Component Strategic Planning Product/Component Validation Planning This presentation focused on three key aspects of Design for Manufacturing (DFM)
  52. 52. 53 There are three key DFM teams, all must execute to enable project success. Questions?
  53. 53. 54 Acknowledgements Assertion-Evidence Template: • http://writing.engr.psu.edu Graphics Support: • Edward Britz • www.edwardbritz.com Presentation Support: • Christine Haas • http://christinehaasconsulting.com Monte Carlo Software: • @RISK by Palisade Corporation • http://www.palisade.com/risk Lowell Dimensional Lab Built by: • Precision Environments • http://precisionenvironmentsinc.com Automated OQ/PQ Minitab Macro Creation: • Mercer Quality Consulting, LLC • http://MercerQualityConsulting.com
  54. 54. Appendix
  55. 55. Lowell’s Newly Completed Quality Lab Temperature: 20 degrees C +/- 0.5 degrees C Humidity: 45% RH +/- 5% RH New Equipment: Based on customer needs
  56. 56. Customer DFMECA Risk Assessment for the component Major Notes Confidence/Reliability Tolerance Intervals 95/90 Attribute Sampling Level 29 Continuous can be less # Features from DWG 11 From DWG Cost Estimate from Cost Model $155 Use upper limit because there is no historical data yet Number of OQ Lots 3 1 min if you can argue it makes sense Number of Parts Per OQ lot 29 standard sample size for 95/90 in industry Total number of OQ parts 87 3*29 Total Cost for OQ Parts $13,485 3*29*$155 OQ Data Analysis Cost $500 5 hrs * $100/hr OQ Report $1,500 15 hrs * $100/hr Number of PQ Lots 3 3 lots minimum Number of Parts Per OQ lot 29 standard sample size for 95/90 in industry Total number of PQ parts 87 3*29 Total Cost for PQ Parts $13,485 3*29*$155 PQ Dara Analysis Cost $500 5 hrs * $100/hr PQ Report $1,500 15 hrs * $100/hr Total OQ Costs $15,485 Total PQ Costs $15,485 PQ parts are sellable parts if they passed, so $$ can subtract out Total Validation Costs $30,970 $31,485 in validation NRE charges Validation Calculations for No Critical Features
  57. 57. Customer DFMECA Risk Assessment for the component Major Notes Confidence/Reliability Tolerance Intervals 95/90 Attribute Sampling Level 29 Continuous can be less # Features from DWG 11 From DWG Cost Estimate from Cost Model $155 Use upper limit because there is no historical data yet Number of OQ Lots 3 1 min if you can argue it makes sense Number of Parts Per OQ lot 29 standard sample size for 95/90 in industry Total number of OQ parts 87 3*29 Total Cost for OQ Parts $13,485 3*29*$155 OQ Dara Analysis Cost $6,000 30 hrs * $200/hr OQ Report $3,000 30 hrs * $100/hr Number of PQ Lots 3 3 lots minimum Number of Parts Per OQ lot 29 standard sample size for 95/90 in industry Total number of PQ parts 87 3*29 Total Cost for PQ Parts $13,485 3*29*$155 PQ Dara Analysis Cost $6,000 30 hrs * $200/hr PQ Report $3,000 30 hrs * $100/hr Total OQ Costs $22,485 Total PQ Costs $22,485 PQ parts are sellable parts if they passed, so $$ can subtract out Total Validation Costs $44,970 $31,485 in validation NRE charges Validation Calculations for All Features Critical
  58. 58. Validation Calculations for Two Critical Features Customer DFMECA Risk Assessment for the component Major Notes Confidence/Reliability Tolerance Intervals 95/90 Attribute Sampling Level 29 Continuous can be less # Features from DWG 11 From DWG Cost Estimate from Cost Model $155 Use upper limit because there is no historical data yet Number of OQ Lots 3 1 min if you can argue it makes sense Number of Parts Per OQ lot 29 standard sample size for 95/90 in industry Total number of OQ parts 87 3*29 Total Cost for OQ Parts $13,485 3*29*$155 OQ Data Analysis Cost $2,000 10 hrs * $200/hr OQ Report $2,000 20 hrs * $100/hr Number of PQ Lots 3 3 lots minimum Number of Parts Per OQ lot 29 standard sample size for 95/90 in industry Total number of PQ parts 87 3*29 Total Cost for PQ Parts $13,485 3*29*$155 PQ Dara Analysis Cost $2,000 10 hrs * $200/hr PQ Report $2,000 20 hrs * $100/hr Total OQ Costs $17,485 Total PQ Costs $17,485 PQ parts are sellable parts if they passed, so $$ can subtract out Total Validation Costs $34,970 $31,485 in validation NRE charges

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