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Metrology:
 The Science of
  Measurement




                  www.alliancecalibration.com
A Bit About Me
Kevin Radzik with Alliance Calibration
  ASQ CCT since 2009
  Technical Manager P&T(Process & Test)
  10+ Years in the Pharmaceutical Industry
          •   Working “in-house” to manage calibration
              programs
          •   Contractor providing calibration & control
              services to the pharmaceutical industry


                     www.alliancecalibration.com
Metrology vs. Calibration
Metrology is the science of measurement.
 Metrology includes all theoretical and
 practical aspects of measurement.
“Metrologia” in ancient Greek meant the
  “Theory of Ratios”
Calibration is the comparison of a “standard” of
 known accuracy to an artifact of unknown
 accuracy.

                  www.alliancecalibration.com
Calibration where you didn't
         know it existed...
Items like deli scales and
   fuel pumps are calibrated
   and certified by local
   government agencies to
   protect customers.
With gas at $4/gallon they
 make sure you are
 getting what you pay for!

                  www.alliancecalibration.com
Calibration where you didn't
        know it existed...
Restaurant chains develop recipes in
 laboratories and refine them to be used in
 their restaurants in the simplest method
 possible. For example deep fry for 3:00
 minutes.
If the laboratory didn't calibrate their
   instruments they could end up producing
   overcooked or worse, undercooked food
      And serving raw chicken would
         be very bad for business!!
                 www.alliancecalibration.com
How Calibration Works
Direct Comparison
2-Devices are
  simultaneously
  measuring the same
  quantity under the
  same conditions



                www.alliancecalibration.com
How Calibration Works
Transfer
The use of a known
 artifact (i.e. gage
 block or mass) to test
 a measuring device.




                 www.alliancecalibration.com
How Calibration Works
Intrinsic
Standards that posses
  a measurable
  quantity by their
  nature
Triple-Point of Water
  cell is 0.01°C with an
  error as low as 5 mK

                   www.alliancecalibration.com
Traceability
Traceability is established
  by an unbroken chain of
  comparisons to a NSI
  (National Standards
  Institute)
Each level of comparison
 will add to the error of
 the measurement
 performed
                  www.alliancecalibration.com
ISO 17025 Accreditation
ISO 17025 was developed to standardize the
  way in which laboratories perform and report
  calibration and testing data.
ISO 17025 accreditation bodies such as LAB,
  A2LA, NAVLAP, A-CLASS, ANAB and others
  ensure compliance to the standard.
  Accreditation bodies recognized by ILAC are
  all considered equivalent.
Accreditation is good assurance that a lab has
 the proper tools www.alliancecalibration.com in place to
                   & practices
 perform calibrations with confidence.
“Hands-On” Demonstration
How long is a piece of string
  On each table there is a calibrated ruler and
   several pieces of string. Please take a moment
   and work together to attempt the most accurate
   measurement of a “piece of string” possible




                   www.alliancecalibration.com
Problems?
Straightness                   Frayed Edges

Pulling Force                  Resolution of the ruler

Lighting Conditions            Eyesight

Temperature                    Humidity
Every measurement apparatus has limitations. These limits
impose a degree of error in every measurement made.

With more specialized equipment we can make better and
better measurements, but there will always be an element of
error based on various conditions.

Measurement uncertainty is used as a method to quantify the
error present in any measurement.
                       www.alliancecalibration.com
Measurement Uncertainty
All sources of error in a given measurement
  must be quantified, and accounted for.
The number sources of error can be as few as:
 accuracy of the standard, uncertainty of the
 standard, resolution and repeatability.
However other items can also influence the
 measurement, such as: temperature,
 temperature Δ, barometric pressure, altitude,
 humidity, and the uncertainty of whatever
 instruments are used to measure these.
                 www.alliancecalibration.com
Measurement Uncertainty
The ISO document “Guide to the expression of
 Uncertainty in Measurement” (the GUM)
 defines the way in which measurement
 uncertainty is calculated.
Contributing factors are quantified and
 corrected to represent 1σ using divisors
 based on the type of contribution the error
 provides.

                  www.alliancecalibration.com
Measurement Uncertainty
The normalized contributors are then combined
 using the “Root of the Sum of Squares” and
 multiplied by a confidence factor.
The confidence factor of k=2 is most commonly
 used, and provides an approximately 95%
 assurance that the true value of the
 measurement is reported within the limits of
 the measurement uncertainty.
Measurement uncertainty defines the “gray
 area” inside of which the true value of a
                  www.alliancecalibration.com

 measurement lies.
Calibration Tracking
In the short term calibration provides a
  reasonable assurance that an instrument is fit
  to be used for the task for which it was
  designed.
However, long term evaluation of calibration
 data can provide increased confidence or
 even predict when a device is likely to “drift”
 out of specification under normal use.

                   www.alliancecalibration.com
Calibration Tracking
At Alliance Calibration
  we provide our
  customers free
  access to our
  eTracking system as
  an easy way to keep
  all your calibration
  data in one easy to
  use web site.
                  www.alliancecalibration.com
Calibration Tracking
There are several additional products available
 to track calibration data, the important thing is
 to use the tool that works for you.
In many industries calibration cycles are
  mandated by standards, but in industries
  where they are not long term trending of
  calibration data can be valuable in
  determining calibration cycles to be the most
  cost effective.
                   www.alliancecalibration.com
Long Term Trending
Plotting data over time and noting
when adjustments or repairs were
required is an excellent method to
visually represent an instrument's
history.

As more history is recorded it
becomes easy to predict when future
failures are likely.

And when anomalies occur along the
trend they become noticeable and
point to possible problems elsewhere
in the quality system.
                       www.alliancecalibration.com
Questions & Comments




        Thank you!!
      www.alliancecalibration.com

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Meterology the science of measurement

  • 1. Metrology: The Science of Measurement www.alliancecalibration.com
  • 2. A Bit About Me Kevin Radzik with Alliance Calibration ASQ CCT since 2009 Technical Manager P&T(Process & Test) 10+ Years in the Pharmaceutical Industry • Working “in-house” to manage calibration programs • Contractor providing calibration & control services to the pharmaceutical industry www.alliancecalibration.com
  • 3. Metrology vs. Calibration Metrology is the science of measurement. Metrology includes all theoretical and practical aspects of measurement. “Metrologia” in ancient Greek meant the “Theory of Ratios” Calibration is the comparison of a “standard” of known accuracy to an artifact of unknown accuracy. www.alliancecalibration.com
  • 4. Calibration where you didn't know it existed... Items like deli scales and fuel pumps are calibrated and certified by local government agencies to protect customers. With gas at $4/gallon they make sure you are getting what you pay for! www.alliancecalibration.com
  • 5. Calibration where you didn't know it existed... Restaurant chains develop recipes in laboratories and refine them to be used in their restaurants in the simplest method possible. For example deep fry for 3:00 minutes. If the laboratory didn't calibrate their instruments they could end up producing overcooked or worse, undercooked food And serving raw chicken would be very bad for business!! www.alliancecalibration.com
  • 6. How Calibration Works Direct Comparison 2-Devices are simultaneously measuring the same quantity under the same conditions www.alliancecalibration.com
  • 7. How Calibration Works Transfer The use of a known artifact (i.e. gage block or mass) to test a measuring device. www.alliancecalibration.com
  • 8. How Calibration Works Intrinsic Standards that posses a measurable quantity by their nature Triple-Point of Water cell is 0.01°C with an error as low as 5 mK www.alliancecalibration.com
  • 9. Traceability Traceability is established by an unbroken chain of comparisons to a NSI (National Standards Institute) Each level of comparison will add to the error of the measurement performed www.alliancecalibration.com
  • 10. ISO 17025 Accreditation ISO 17025 was developed to standardize the way in which laboratories perform and report calibration and testing data. ISO 17025 accreditation bodies such as LAB, A2LA, NAVLAP, A-CLASS, ANAB and others ensure compliance to the standard. Accreditation bodies recognized by ILAC are all considered equivalent. Accreditation is good assurance that a lab has the proper tools www.alliancecalibration.com in place to & practices perform calibrations with confidence.
  • 11. “Hands-On” Demonstration How long is a piece of string On each table there is a calibrated ruler and several pieces of string. Please take a moment and work together to attempt the most accurate measurement of a “piece of string” possible www.alliancecalibration.com
  • 12. Problems? Straightness Frayed Edges Pulling Force Resolution of the ruler Lighting Conditions Eyesight Temperature Humidity Every measurement apparatus has limitations. These limits impose a degree of error in every measurement made. With more specialized equipment we can make better and better measurements, but there will always be an element of error based on various conditions. Measurement uncertainty is used as a method to quantify the error present in any measurement. www.alliancecalibration.com
  • 13. Measurement Uncertainty All sources of error in a given measurement must be quantified, and accounted for. The number sources of error can be as few as: accuracy of the standard, uncertainty of the standard, resolution and repeatability. However other items can also influence the measurement, such as: temperature, temperature Δ, barometric pressure, altitude, humidity, and the uncertainty of whatever instruments are used to measure these. www.alliancecalibration.com
  • 14. Measurement Uncertainty The ISO document “Guide to the expression of Uncertainty in Measurement” (the GUM) defines the way in which measurement uncertainty is calculated. Contributing factors are quantified and corrected to represent 1σ using divisors based on the type of contribution the error provides. www.alliancecalibration.com
  • 15. Measurement Uncertainty The normalized contributors are then combined using the “Root of the Sum of Squares” and multiplied by a confidence factor. The confidence factor of k=2 is most commonly used, and provides an approximately 95% assurance that the true value of the measurement is reported within the limits of the measurement uncertainty. Measurement uncertainty defines the “gray area” inside of which the true value of a www.alliancecalibration.com measurement lies.
  • 16. Calibration Tracking In the short term calibration provides a reasonable assurance that an instrument is fit to be used for the task for which it was designed. However, long term evaluation of calibration data can provide increased confidence or even predict when a device is likely to “drift” out of specification under normal use. www.alliancecalibration.com
  • 17. Calibration Tracking At Alliance Calibration we provide our customers free access to our eTracking system as an easy way to keep all your calibration data in one easy to use web site. www.alliancecalibration.com
  • 18. Calibration Tracking There are several additional products available to track calibration data, the important thing is to use the tool that works for you. In many industries calibration cycles are mandated by standards, but in industries where they are not long term trending of calibration data can be valuable in determining calibration cycles to be the most cost effective. www.alliancecalibration.com
  • 19. Long Term Trending Plotting data over time and noting when adjustments or repairs were required is an excellent method to visually represent an instrument's history. As more history is recorded it becomes easy to predict when future failures are likely. And when anomalies occur along the trend they become noticeable and point to possible problems elsewhere in the quality system. www.alliancecalibration.com
  • 20. Questions & Comments Thank you!! www.alliancecalibration.com