1. Limited Calibration …. it’s not a dirty word! (Calibration Practice Impact on Business) Author: Phil Mistretta NCSLI Orlando, FL 6 Aug 08 Section 6C Metrology’s Impact on Business Slide 1 of 21

2. Session Topics Business’ Impact on Metrology Metrology Results: Technical Impact on Customer Process Metrology Practice Impact on Business Business’ Impact on Metrology Metrology Results: Technical Impact on Customer Process Metrology Practice Impact on Business Business’ Impact on Metrology Metrology Results: Technical Impact on Customer Process Metrology Practice Impact on Business Responsibility Communication Expectations How do these relate to business? –It is critical that any calibration service provider (CSP) take responsibility to understand their client’s needs and business requirements. –Likewise, it is critical that any instrument owner communicate their needs and business requirements to their service provider. –These two checks and balances will ensure an optimal calibration that meets both customer expectations and business requirements. Author: Phil Mistretta NCSLI Orlando, FL 6 Aug 08 Section 6C Metrology’s Impact on Business Slide 2 of 21

3. Introduction cGMP – Current Good Manufacturing Practices GLP – Good Laboratory Practices GMP – Good Measurement Practices GMetP – Good Metrology Practices Established Customer Performance Expectation –Customer initial purchase decision based on OEM Specifications Calibration Expectations –What the customer wants from the Metrology Lab Calibration Service Provider Policies –Calibration Procedures –Full Calibration –Custom Calibration –Data Only Calibration –Limited Calibration Author: Phil Mistretta NCSLI Orlando, FL 6 Aug 08 Section 6C Metrology’s Impact on Business Slide 3 of 21

4. Limited Calibration An instrument is considered to have a Limited Calibration when a Parameter, Range, or Function: is not working correctly and can not be checked not checked or calibrated calibrated to a less stringent tolerance Author: Phil Mistretta NCSLI Orlando, FL 6 Aug 08 Section 6C Metrology’s Impact on Business Slide 4 of 21

5. Limited Calibration Case 1.Out-of-Tolerance: Not Adjustable, Not Repairable Author: Phil Mistretta NCSLI Orlando, FL 6 Aug 08 Section 6C Metrology’s Impact on Business Slide 5 of 21

6. Limited Calibration Case Out-of-Tolerance: Not Adjustable, Not Repairable Failure or Out-of-Tolerance: Adjustable, Repairable Author: Phil Mistretta NCSLI Orlando, FL 6 Aug 08 Section 6C Metrology’s Impact on Business Slide 6 of 21

7. Limited Calibration Case Out-of-Tolerance: Not Adjustable, Not Repairable Failure or Out-of-Tolerance: Adjustable, Repairable Lab Standards Not Available Author: Phil Mistretta NCSLI Orlando, FL 6 Aug 08 Section 6C Metrology’s Impact on Business Slide 7 of 21

8. Limited Calibration Case Out-of-Tolerance: Not Adjustable, Not Repairable Failure or Out-of-Tolerance: Adjustable, Repairable Lab Standards Not Available Measurement Uncertainty Not Met Author: Phil Mistretta NCSLI Orlando, FL 6 Aug 08 Section 6C Metrology’s Impact on Business Slide 8 of 21

9. Measurement Uncertainty Not Met Customer 4:1 TUR Requirement Not met, labeled Calibrated Customer 4:1 TUR Requirement Met, labeled Limited Calibration Limited Calibration Author: Phil Mistretta NCSLI Orlando, FL 6 Aug 08 Section 6C Metrology’s Impact on Business Slide 9 of 21

10. Limited Calibration Case Out-of-Tolerance: Not Adjustable, Not Repairable Failure or Out-of-Tolerance: Adjustable, Repairable Lab Standards Not Available Measurement Uncertainty Not Met Author: Phil Mistretta NCSLI Orlando, FL 6 Aug 08 Section 6C Metrology’s Impact on Business Slide 10 of 21

11. Case 1.Out-of-Tolerance: Not Adjustable, Not Repairable 2.Failure or Out-of-Tolerance: Adjustable, Repairable 3.Lab Standards Not Available 4.Measurement Uncertainty Not Met 5.Parameter / Range / Function Not Calibrated 1. AC Volts5 Ranges 2. DC Volts5 Ranges 3. AC Current4 Ranges 4. DC Current4 Ranges 5. Resistance7 Ranges 6. Capacitance4 Ranges 7. Frequency5 Ranges Limited Calibration Author: Phil Mistretta NCSLI Orlando, FL 6 Aug 08 Section 6C Metrology’s Impact on Business Slide 11 of 21

12. Risk Management Evaluate Approve Inform Manage Author: Phil Mistretta NCSLI Orlando, FL 6 Aug 08 Section 6C Metrology’s Impact on Business Slide 12 of 21

13. Evaluate Class X Gage TUR Class Y Gage TUR Risk Management Author: Phil Mistretta NCSLI Orlando, FL 6 Aug 08 Section 6C Metrology’s Impact on Business Slide 13 of 21

14. Risk Management Evaluate Approve Inform Manage Author: Phil Mistretta NCSLI Orlando, FL 6 Aug 08 Section 6C Metrology’s Impact on Business Slide 14 of 21

15. Why go through all this? Potential Benefits –Reduced Calibration Cost –Shorter Calibration Procedure –Quicker Turn Times –Reduced Process Down Time Limited Calibration Author: Phil Mistretta NCSLI Orlando, FL 6 Aug 08 Section 6C Metrology’s Impact on Business Slide 15 of 21

16. Summary A limited calibration is nothing to be feared! They have benefits with real value. Systematic Approach Knowledgeable People Informed Decision Proper Documentation (Objective Evidence) Author: Phil Mistretta NCSLI Orlando, FL 6 Aug 08 Section 6C Metrology’s Impact on Business Slide 2 of 21

17. Business’ Impact on Metrology Metrology Results: Technical Impact on Customer Process Metrology Practice Impact on Business Conclusion Business’ Impact on Metrology Metrology Results: Technical Impact on Customer Process Metrology Practice Impact on Business Business’ Impact on Metrology Metrology Results: Technical Impact on Customer Process Metrology Practice Impact on Business Responsibility Communication Expectations How do these relate to business? –It is critical that any calibration service provider (CSP) take responsibility to understand their client’s needs and business requirements. –Likewise, it is critical that any instrument owner communicate their needs and business requirements to their service provider. –These two checks and balances will ensure an optimal calibration that meets both customer expectations and business requirements. Author: Phil Mistretta NCSLI Orlando, FL 6 Aug 08 Section 6C Metrology’s Impact on Business Slide 17 of 21

18. Product Design Manufacturing Process Specs Metrology Impact Engineering Design Specs Business’ Requirements Supplier’s Requirements What is the Link between Business and Metrology? Supplier’s Requirements Product Design Manufacturing Process Specs Engineering Design Specs Metrology Impact Business’ Requirements Author: Phil Mistretta NCSLI Orlando, FL 6 Aug 08 Section 6C Metrology’s Impact on Business Slide 18 of 21

19. Metrology Impact What happens to the manufacturing process if... ? Quality Issues Customer Service Issues Turn Time Accreditation / Traceability Limited CalDocumentation Issues Lab Assets Down Customer Approval Delays ≥4:1 TUR but PCS < 1 Shipping Damage <4:1 TUR Onsite Expectations Change What is the Link between Business and Metrology? Author: Phil Mistretta NCSLI Orlando, FL 6 Aug 08 Section 6C Metrology’s Impact on Business Slide 19 of 21

20. What is the Link between Business and Metrology? Metrology Impact What happens to the business if... ? Quality Issues Customer Service Issues Typically causes unnecessary production delays May cause bad product which can lead to product recall Bad product = Increased Risk Increased Scrap/Waste Increased Cost Production delays = Increased Cost Delivery Delays to Client Loss of competitive advantage Manufacturing Process ImpactSupplier / Business Impact Author: Phil Mistretta NCSLI Orlando, FL 6 Aug 08 Section 6C Metrology’s Impact on Business Slide 20 of 21

21. Limited Calibration …. it’s not a dirty word! (Calibration Practice Impact on Business) Questions? Thank You. Author: Phil Mistretta NCSLI Orlando, FL 6 Aug 08 Section 6C Metrology’s Impact on Business Slide 21 of 21