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Calibration s
Calibration’s Role
in the Manufacturing Jigsaw Puzzle
                   g g



          Webinar hosted and presented by
                             p          y




Better by Your Every Measure • 800.828.1470 • www.transcat.com
Agenda

   The Big Picture: Manufacturing Goals
          g                        g
   Puzzle Pieces: Segregation of Departments/Functions
   The Calibration Puzzle Piece
   The Piece Appears to Fit . . . But Does It Really?
   Getting the Pieces to Fit Properly
          g                      p y




                  Better by Your Every Measure • 800.828.1470 • www.transcat.com
The Big Picture: Manufacturing Goals

 Making p
       g products that are:
  •   In market demand
  •   Profitable
  •   Effective
        ff
  •   Safe




                   Better by Your Every Measure • 800.828.1470 • www.transcat.com
Puzzle Pieces: Segregation of Depts/Functions

 Some functions of the manufacturing p
                                    g process are split apart
                                                   p     p
  into separate departments
 Some functions or sub-functions/sub-assemblies are
  outsourced




                 Better by Your Every Measure • 800.828.1470 • www.transcat.com
Puzzle Pieces: Segregation of Depts/Functions

 Materials are purchased from multiple sources
                p                   p
 Sub-assemblies are made at local tool shops
  • Some companies enforce quality of parts on the supplier
  • Some companies check a sample of supplier parts for quality




                   Better by Your Every Measure • 800.828.1470 • www.transcat.com
The Calibration Puzzle Piece(s)

 How has Calibration been segregated from the
                               g g
  manufacturing process?
 What was the original point of calibration in manufacturing?
  • Many manufacturers have lost the connection between calibration
    and the original goals of business
 How has this ‘calibration silo affected manufacturing?
                calibration silo’




                  Better by Your Every Measure • 800.828.1470 • www.transcat.com
The Piece Appears to Fit . . . But Does It Really?

 Calibrations may be taking p
                    y       g place but . . .
 . . . that doesn’t mean Measurement Assurance is in place!
  • Example: Omega HH82A
  • What similar risks do your current calibrations impose?




                   Better by Your Every Measure • 800.828.1470 • www.transcat.com
Getting the Pieces to Fit Properly

 If a manufacturing business is interested in:
                   g
  • Maximizing Profits
  • Product Safety & Quality . . .
 Then they must have an active Measurement Assurance
  program




                    Better by Your Every Measure • 800.828.1470 • www.transcat.com
Getting the Pieces to Fit Properly

 An active Measurement Assurance program consists of:
  • Right tool for the job (i.e., suitability)
  • Regular calibration
     – Calibrations that support the process where the instrument is
        used
     – Calibrations that supply the correct tolerances
     – Calibrations that are valid (i.e., calibration measurement
        uncertainties support the measurements made)
  • Using the instrument/tool correctly
  • Accounting for irregularities in the production measurement process
    (i.e., Process measurement uncertainties)
  • OOT investigations performed properly
  • Corrective action taken for OOT impacting product

                   Better by Your Every Measure • 800.828.1470 • www.transcat.com
Getting the Pieces to Fit Properly

 Example: Temperature measurement
      p       p
  • Mfg Engineer needs to measure solution used to treat product
  • Process measurement is 350° ± 2° C
  • Which instrument is suitable f this measurement?
                                 for                ?
         LL:                                               UL:
       Process                                           Process




       348°C                   350°C                     352°C



                   Better by Your Every Measure • 800.828.1470 • www.transcat.com
Getting the Pieces to Fit Properly

 Process measurement
  • An instrument with an accuracy equal to the process limits?
  • Not good because the instrument can drift the full amount over its cal
    interval,
    interval directly impacting previous process measurements
         LL:                                               UL:
       Process                                           Process




       348°C                   350°C                     352°C



                   Better by Your Every Measure • 800.828.1470 • www.transcat.com
Getting the Pieces to Fit Properly

 Process measurement
  • Instrument has been calibrated today and adjusted to nominal
  • Instrument is used to measure solution temperature the same day
  • S
    Solution temperature is right at nominal: 350° C
                                                 °
         LL:                                              UL:
       Process                                          Process




       348°C                  350°C                     352°C



                  Better by Your Every Measure • 800.828.1470 • www.transcat.com
Getting the Pieces to Fit Properly

 Process measurement
  • Instrument is on its last day of use before it will be recalibrated
  • Instrument is used to measure solution temperature
  • S
    Solution temperature is right at nominal: 350° C
                                                   °
          LL:                                               UL:
        Process                                           Process




        348°C                   350°C                     352°C



                    Better by Your Every Measure • 800.828.1470 • www.transcat.com
Getting the Pieces to Fit Properly

 Temperature Instrument Calibration
     p
  • Instrument is recalibrated (and subsequently was adjusted)
  • As Found reading shows the instrument drifted to upper limit: 352° C
  • This drift occurred over its calibration interval
            f
        LL:                                               UL:
        UUT                                               UUT




       348°C                   350°C                     352°C



                   Better by Your Every Measure • 800.828.1470 • www.transcat.com
Getting the Pieces to Fit Properly

 Temperature Instrument Calibration
     p
  • Did it move all at once or a little over time?
  • How does this impact the measurements of the process since the
    last time the temperature instrument was calibrated?
        LL:                                              UL:
        UUT                                              UUT




       348°C                  350°C                     352°C



                  Better by Your Every Measure • 800.828.1470 • www.transcat.com
Getting the Pieces to Fit Properly

 OOT-NCR Evaluation
  • It must be assumed this shift occurred immediately following the last
    calibration because that is the only supporting evidence to show the
    last known good condition of its temperature values
         LL:                                               UL:
       Process                                           Process




                                x

       348°C                   350°C                     352°C



                   Better by Your Every Measure • 800.828.1470 • www.transcat.com
Getting the Pieces to Fit Properly

 OOT-NCR Evaluation
  • So the process measurements taken on the day the instrument was
    previously calibrated were not actually 350° C, they were 348° C
  • The same applies to the process readings at the end of the cal cycle
         LL:                                               UL:
       Process                                           Process




                                x

       348°C                   350°C                     352°C



                   Better by Your Every Measure • 800.828.1470 • www.transcat.com
Getting the Pieces to Fit Properly

 OOT-NCR Evaluation
  • What if some process readings indicated the solution was at its lower
    limit: 348° C? This would be acceptable for the process test, but . . .
  • The In Tolerance cal would not have flagged this situation as ‘at risk’!!
                                                                   at risk !!
         LL:                                                UL:
       Process                                            Process




         x

        348°C                   350°C                     352°C



                    Better by Your Every Measure • 800.828.1470 • www.transcat.com
Getting the Pieces to Fit Properly

 Instrument with better accuracy:
                                y
  • What if an instrument was selected with an accuracy twice as good?
  • If it drifted to its limit, process readings would only be off half of the
    process tolerance
          LL:       LL:                        UL:           UL:
        Process     UUT                        UUT         Process




                                               x

        348°C       349°C        350°C        351°C        352°C



                     Better by Your Every Measure • 800.828.1470 • www.transcat.com
Getting the Pieces to Fit Properly

 Instrument with better accuracy:
                                y
  • What if an instrument was selected with an accuracy 4X as good?
  • If it drifted to its limit, process readings would only be off one quarter
    of the process tolerance
          LL:             LL:              UL:              UL:
        Process           UUT              UUT            Process




                                           x

        348°C            349.5°C   350°C 350.5°C          352°C



                    Better by Your Every Measure • 800.828.1470 • www.transcat.com
Getting the Pieces to Fit Properly

 Instrument with better accuracy:
                                y
  • How far can we take this? 10X better? 100X better?
  • There are limits of technology and/or it eventually becomes cost
    prohibitive to go too far with this concept
         LL:             LL:              UL:              UL:
       Process           UUT              UUT            Process




                                          x

       348°C            349.5°C   350°C 350.5°C          352°C



                   Better by Your Every Measure • 800.828.1470 • www.transcat.com
Getting the Pieces to Fit Properly

 Instrument with better accuracy:
                                y
  • Traditionally, a 4:1 ratio is sufficient to reduce the probability that an
    OOT will have an impact on the product/process
  • For some measurements this cannot be achieved so risk is higher
              measurements,                       achieved,
          LL:              LL:              UL:              UL:
        Process            UUT              UUT            Process




                                            x

        348°C             349.5°C   350°C 350.5°C          352°C



                     Better by Your Every Measure • 800.828.1470 • www.transcat.com
Getting the Pieces to Fit Properly

 Instrument with better accuracy:
                                y
  • However, if one or more of the process measurements was at its
    lower limit . . . risk still exists for this “In Tolerance” calibration
  • Using the “As Found cal value all readings were higher by 0 5° C
                As Found”           value,                                0.5°
              LL:           LL:              UL:              UL:
            Process         UUT              UUT            Process




  347.5°C
             x

            348°C          349.5°C   350°C 350.5°C          352°C



                      Better by Your Every Measure • 800.828.1470 • www.transcat.com
Getting the Pieces to Fit Properly

 Lesson Learned:
  • Even In Tolerance results can impact your process measurements!
  • All cal data must be reviewed against process measurements to
    understand the impact to the product (IT NCR evaluation)
                                          (IT-NCR
  • Impact studies are expensive; consumes valuable resources
  • Can cost thousands of dollars per evaluation event
                                    p
  • Parts or product likely have already been released/shipped
  • Could require product recall
  • If not released, could require rework
  • This risk can be reduced
  • Guard Band the process limits!




                  Better by Your Every Measure • 800.828.1470 • www.transcat.com
Getting the Pieces to Fit Properly

 What is Guard Band?
  • Determine realistic tolerance limits for the process measurement
  • Reduce these limits by the tolerance of the instrument used in the
    process to arrive at Lower/Upper Acceptance Limits
              LL:      LAL:           LL:              UL:      UAL:       UL:
            Process   Process         UUT              UUT     Process   Process




  347.5°C
             x x

            348°C     348.5°C        349.5°C   350°C 350.5°C   351.5°C   352°C



                                Better by Your Every Measure • 800.828.1470 • www.transcat.com
Getting the Pieces to Fit Properly

 Guard Band result:
  • Now if the instrument cal reveals a drift up to the maximum tolerance
    there is no need to perform IT-NCR evaluation
  • If instrument error is greater than this (i e it is OOT) then OOT NCR
                                             (i.e.      OOT),     OOT-NCR
         LL:      LAL:           LL:              UL:      UAL:       UL:
       Process   Process         UUT              UUT     Process   Process




                   x

       348°C     348.5°C        349.5°C   350°C 350.5°C   351.5°C   352°C



                           Better by Your Every Measure • 800.828.1470 • www.transcat.com
Getting the Pieces to Fit Properly

 Summary:
        y
  • Implement a good Measurement Assurance Program
  • Understand and exercise good Suitability selection
  • Guard Band the process tolerance limits to reduce costly NCR evals
    G                                                         C
  • Understand both the process and the calibration to ensure the intent
    of preserving good measurements on the product is not lost
       p         gg                          p
  • Be thorough in your NCR evaluations
  • Get help if you’re in over your head!




                   Better by Your Every Measure • 800.828.1470 • www.transcat.com
Thank You for Joining Us!

  Questions?

    800.828.1470
  www.transcat.com

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  • 1. Calibration s Calibration’s Role in the Manufacturing Jigsaw Puzzle g g Webinar hosted and presented by p y Better by Your Every Measure • 800.828.1470 • www.transcat.com
  • 2. Agenda  The Big Picture: Manufacturing Goals g g  Puzzle Pieces: Segregation of Departments/Functions  The Calibration Puzzle Piece  The Piece Appears to Fit . . . But Does It Really?  Getting the Pieces to Fit Properly g p y Better by Your Every Measure • 800.828.1470 • www.transcat.com
  • 3. The Big Picture: Manufacturing Goals  Making p g products that are: • In market demand • Profitable • Effective ff • Safe Better by Your Every Measure • 800.828.1470 • www.transcat.com
  • 4. Puzzle Pieces: Segregation of Depts/Functions  Some functions of the manufacturing p g process are split apart p p into separate departments  Some functions or sub-functions/sub-assemblies are outsourced Better by Your Every Measure • 800.828.1470 • www.transcat.com
  • 5. Puzzle Pieces: Segregation of Depts/Functions  Materials are purchased from multiple sources p p  Sub-assemblies are made at local tool shops • Some companies enforce quality of parts on the supplier • Some companies check a sample of supplier parts for quality Better by Your Every Measure • 800.828.1470 • www.transcat.com
  • 6. The Calibration Puzzle Piece(s)  How has Calibration been segregated from the g g manufacturing process?  What was the original point of calibration in manufacturing? • Many manufacturers have lost the connection between calibration and the original goals of business  How has this ‘calibration silo affected manufacturing? calibration silo’ Better by Your Every Measure • 800.828.1470 • www.transcat.com
  • 7. The Piece Appears to Fit . . . But Does It Really?  Calibrations may be taking p y g place but . . .  . . . that doesn’t mean Measurement Assurance is in place! • Example: Omega HH82A • What similar risks do your current calibrations impose? Better by Your Every Measure • 800.828.1470 • www.transcat.com
  • 8. Getting the Pieces to Fit Properly  If a manufacturing business is interested in: g • Maximizing Profits • Product Safety & Quality . . .  Then they must have an active Measurement Assurance program Better by Your Every Measure • 800.828.1470 • www.transcat.com
  • 9. Getting the Pieces to Fit Properly  An active Measurement Assurance program consists of: • Right tool for the job (i.e., suitability) • Regular calibration – Calibrations that support the process where the instrument is used – Calibrations that supply the correct tolerances – Calibrations that are valid (i.e., calibration measurement uncertainties support the measurements made) • Using the instrument/tool correctly • Accounting for irregularities in the production measurement process (i.e., Process measurement uncertainties) • OOT investigations performed properly • Corrective action taken for OOT impacting product Better by Your Every Measure • 800.828.1470 • www.transcat.com
  • 10. Getting the Pieces to Fit Properly  Example: Temperature measurement p p • Mfg Engineer needs to measure solution used to treat product • Process measurement is 350° ± 2° C • Which instrument is suitable f this measurement? for ? LL: UL: Process Process 348°C 350°C 352°C Better by Your Every Measure • 800.828.1470 • www.transcat.com
  • 11. Getting the Pieces to Fit Properly  Process measurement • An instrument with an accuracy equal to the process limits? • Not good because the instrument can drift the full amount over its cal interval, interval directly impacting previous process measurements LL: UL: Process Process 348°C 350°C 352°C Better by Your Every Measure • 800.828.1470 • www.transcat.com
  • 12. Getting the Pieces to Fit Properly  Process measurement • Instrument has been calibrated today and adjusted to nominal • Instrument is used to measure solution temperature the same day • S Solution temperature is right at nominal: 350° C ° LL: UL: Process Process 348°C 350°C 352°C Better by Your Every Measure • 800.828.1470 • www.transcat.com
  • 13. Getting the Pieces to Fit Properly  Process measurement • Instrument is on its last day of use before it will be recalibrated • Instrument is used to measure solution temperature • S Solution temperature is right at nominal: 350° C ° LL: UL: Process Process 348°C 350°C 352°C Better by Your Every Measure • 800.828.1470 • www.transcat.com
  • 14. Getting the Pieces to Fit Properly  Temperature Instrument Calibration p • Instrument is recalibrated (and subsequently was adjusted) • As Found reading shows the instrument drifted to upper limit: 352° C • This drift occurred over its calibration interval f LL: UL: UUT UUT 348°C 350°C 352°C Better by Your Every Measure • 800.828.1470 • www.transcat.com
  • 15. Getting the Pieces to Fit Properly  Temperature Instrument Calibration p • Did it move all at once or a little over time? • How does this impact the measurements of the process since the last time the temperature instrument was calibrated? LL: UL: UUT UUT 348°C 350°C 352°C Better by Your Every Measure • 800.828.1470 • www.transcat.com
  • 16. Getting the Pieces to Fit Properly  OOT-NCR Evaluation • It must be assumed this shift occurred immediately following the last calibration because that is the only supporting evidence to show the last known good condition of its temperature values LL: UL: Process Process x 348°C 350°C 352°C Better by Your Every Measure • 800.828.1470 • www.transcat.com
  • 17. Getting the Pieces to Fit Properly  OOT-NCR Evaluation • So the process measurements taken on the day the instrument was previously calibrated were not actually 350° C, they were 348° C • The same applies to the process readings at the end of the cal cycle LL: UL: Process Process x 348°C 350°C 352°C Better by Your Every Measure • 800.828.1470 • www.transcat.com
  • 18. Getting the Pieces to Fit Properly  OOT-NCR Evaluation • What if some process readings indicated the solution was at its lower limit: 348° C? This would be acceptable for the process test, but . . . • The In Tolerance cal would not have flagged this situation as ‘at risk’!! at risk !! LL: UL: Process Process x 348°C 350°C 352°C Better by Your Every Measure • 800.828.1470 • www.transcat.com
  • 19. Getting the Pieces to Fit Properly  Instrument with better accuracy: y • What if an instrument was selected with an accuracy twice as good? • If it drifted to its limit, process readings would only be off half of the process tolerance LL: LL: UL: UL: Process UUT UUT Process x 348°C 349°C 350°C 351°C 352°C Better by Your Every Measure • 800.828.1470 • www.transcat.com
  • 20. Getting the Pieces to Fit Properly  Instrument with better accuracy: y • What if an instrument was selected with an accuracy 4X as good? • If it drifted to its limit, process readings would only be off one quarter of the process tolerance LL: LL: UL: UL: Process UUT UUT Process x 348°C 349.5°C 350°C 350.5°C 352°C Better by Your Every Measure • 800.828.1470 • www.transcat.com
  • 21. Getting the Pieces to Fit Properly  Instrument with better accuracy: y • How far can we take this? 10X better? 100X better? • There are limits of technology and/or it eventually becomes cost prohibitive to go too far with this concept LL: LL: UL: UL: Process UUT UUT Process x 348°C 349.5°C 350°C 350.5°C 352°C Better by Your Every Measure • 800.828.1470 • www.transcat.com
  • 22. Getting the Pieces to Fit Properly  Instrument with better accuracy: y • Traditionally, a 4:1 ratio is sufficient to reduce the probability that an OOT will have an impact on the product/process • For some measurements this cannot be achieved so risk is higher measurements, achieved, LL: LL: UL: UL: Process UUT UUT Process x 348°C 349.5°C 350°C 350.5°C 352°C Better by Your Every Measure • 800.828.1470 • www.transcat.com
  • 23. Getting the Pieces to Fit Properly  Instrument with better accuracy: y • However, if one or more of the process measurements was at its lower limit . . . risk still exists for this “In Tolerance” calibration • Using the “As Found cal value all readings were higher by 0 5° C As Found” value, 0.5° LL: LL: UL: UL: Process UUT UUT Process 347.5°C x 348°C 349.5°C 350°C 350.5°C 352°C Better by Your Every Measure • 800.828.1470 • www.transcat.com
  • 24. Getting the Pieces to Fit Properly  Lesson Learned: • Even In Tolerance results can impact your process measurements! • All cal data must be reviewed against process measurements to understand the impact to the product (IT NCR evaluation) (IT-NCR • Impact studies are expensive; consumes valuable resources • Can cost thousands of dollars per evaluation event p • Parts or product likely have already been released/shipped • Could require product recall • If not released, could require rework • This risk can be reduced • Guard Band the process limits! Better by Your Every Measure • 800.828.1470 • www.transcat.com
  • 25. Getting the Pieces to Fit Properly  What is Guard Band? • Determine realistic tolerance limits for the process measurement • Reduce these limits by the tolerance of the instrument used in the process to arrive at Lower/Upper Acceptance Limits LL: LAL: LL: UL: UAL: UL: Process Process UUT UUT Process Process 347.5°C x x 348°C 348.5°C 349.5°C 350°C 350.5°C 351.5°C 352°C Better by Your Every Measure • 800.828.1470 • www.transcat.com
  • 26. Getting the Pieces to Fit Properly  Guard Band result: • Now if the instrument cal reveals a drift up to the maximum tolerance there is no need to perform IT-NCR evaluation • If instrument error is greater than this (i e it is OOT) then OOT NCR (i.e. OOT), OOT-NCR LL: LAL: LL: UL: UAL: UL: Process Process UUT UUT Process Process x 348°C 348.5°C 349.5°C 350°C 350.5°C 351.5°C 352°C Better by Your Every Measure • 800.828.1470 • www.transcat.com
  • 27. Getting the Pieces to Fit Properly  Summary: y • Implement a good Measurement Assurance Program • Understand and exercise good Suitability selection • Guard Band the process tolerance limits to reduce costly NCR evals G C • Understand both the process and the calibration to ensure the intent of preserving good measurements on the product is not lost p gg p • Be thorough in your NCR evaluations • Get help if you’re in over your head! Better by Your Every Measure • 800.828.1470 • www.transcat.com
  • 28. Thank You for Joining Us! Questions? 800.828.1470 www.transcat.com