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Conference Proceedings 2015 (51)

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Picture of the productA New Approach to Calibrate Amplitude Modulation Receiver
Woo Chi, Metrology Division, Naval Air Warfare Center
The procurement of a replacement measuring receiver (Rohde & Schwarz FSMR26-N) brought in unexpected challenge to the NAVAIR Metrology Calibration program. The old measuring receiver (HP 8902A) had an AM calibration output port that generates a precise AM, which was used to calibrate the AM measurement function. The new measuring receiver did not come with such a port. This paper will explain how the NAVAIR overcame this issue by utilizing the measuring receiver’s relative power measurement of tuned RF level mode.


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CP_15_CHI
Picture of the productA Statistical Approach to Primary Radiation Thermometer Drif
Tom Kolat, Fluke Calibration
Radiation thermometers constitute a high accuracy class of measurement devices used for the detection and measurement of radiance and radiation temperature emitted by primary standard blackbody cavities and infrared flat plate calibration sources. These primary grade thermometers are employed by standards laboratories and National Measurement Institutes (NMIs) to measure and assess many source radiation temperature output characteristics, including size of source, source emissivity and the output emission passband. Not unlike the best electronic standards used in any measurement discipline, radiation thermometers exhibit measurement changes over time otherwise called drift. Radiation thermometer drift can introduce unfamiliar offsets in the final measurement results without knowledge of the drift behavior. This paper describes a method for quantifying drift and its uncertainty in radiation thermometry based on statistics work published in literature by the former National Bureau of Standards (NBS).


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CP_15_5C-KOLAT
Picture of the productAccreditation for Dimensional Testing with CMMs
Edward Morse, Center for Precision Metrology, UNC Charlotte
This paper will address some of the issues surrounding the accreditation of laboratories for dimensional testing (and calibration) using Coordinate Measuring Machines (CMMs). The differences between calibrating instruments and using them for subsequent measurements will be explained. This is particularly important with CMMs because their calibration is made up of very specific measurements, while subsequent measurements can cover an enormous range of measurands (length, diameter, flatness, true position, runout, and many more). Given this difference in calibration and use, the next step is to discuss how measurement uncertainty for this discipline will appear on a scope of accreditation, and then the different ways that the uncertainty could, or should, appear on a test or calibration certificate.

Although many CMMs are operated under direct computer control, with validated software to perform calculations, the interpretation of part drawings and the ability to transform the part specification into a measurement program to determine conformance relies heavily on the CMM programmer's knowledge of both GD&T and the CMM software implementation of GD&T.

The next section of this paper will discuss the qualitative and quantitative evaluations that occur in the evaluation of a laboratory that performs CMM measurements, either for internal or external customers. While these subjects will be addressed in the context of laboratory accreditation, the underlying principles are important for anyone who has to justify the value of the CMM measurements that they perform.


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CP_15_9B-MORSE
Picture of the productAccuracy of Liquid Delivery Using Pipettes • Reproducibility
George Rodrigues and Doreen Rumery, Artel
Pipetting accuracy is critical to patient diagnosis, drug safety, criminal convictions and measurement quality in laboratories. Yet the measure of pipetting accuracy (uncertainty of the delivered volume) is not yet expressed in a standard way that permits meaningful evaluation of the options available to purchasers of pipettes and pipette calibration services. Previous work has reported that pipette calibration CMCs among accredited laboratories vary widely, perhaps wildly, and without apparent relationship to the level of compliance with standardized best practices. For practical purposes, the published CMC alone is not a reliable indicator of laboratory competence with pipettes, and more likely simply reflects that the particular contributors that an individual laboratory chooses to include or omit from their CMC. Efforts are underway to correct the situation. Standards development and metrology organizations have begun working together to understand and specify the important contributors that must be included in a pipette uncertainty analysis. Accreditation organizations are also working to fill the gap with specific requirements that allow technical specifiers to understand and compare when they are purchasing. This paper is an effort to provide transparency into one uncertainty contributor that is reputed to be the most significant factor in pipette calibration uncertainty - the effect of operator variation on the mean volume.


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CP_15_6D- RODRI
Picture of the productAn Electronic Calibration Label and its Compliance
Dimaries Nieves, National Instruments
Throughout the modern calibration history, printed labels have being used to identify the calibration status of a measurement instrument and provide relevant information to the end user. The current version of ISO 17025:2005, in section 5, indicates that a label is required to provide information about instruments’ calibration. For accredited calibrations, accreditation bodies have specific requirements and guidelines to use and control the printed calibration labels displayed on instruments. In summary, a label is used to provide key calibration information for a measurement instrument. With the introduction of modular instrumentation in the measurement world, the usage of printed calibration labels is changing. Due to modular instrument design and architecture, electronic calibration labels are replacing the current and traditional printed calibration labels. However, the use of electronic calibration labels creates some new questions. Are the current labeling guidelines, instructions, and controls applicable to the electronic labels? How can the quality systems incorporate and maintain compliance of the electronic labels with the requirements? This paper describes an application comparison between the of electronic and printed calibration labels. We will provide recommendations to end users, calibration laboratories, and auditors in order to verify the compliance with the calibration and quality system requirements.


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CP_15_NIEVES
Picture of the productBest Lessons Learned from FDA Warning Letters
Walter Nowocin, Medtronic Inc.
The current regulatory climate is intense as the U.S. Food & Drug Administration (FDA) has ratcheted up their compliance oversight with more Warning Letters being sent to Healthcare companies. Warning Letters are issued only for violations of regulatory significance. The good news is that the FDA publishes all Warning Letters on their web site as a public service. And they have a very easy search engine that allows you to find Warning Letters that contain topics particular to your industry or job. This paper reviews calibration related FDA Warning Letters generated over the past twelve months. We will analyze the best Warning Letter examples and discuss best practices that would avoid these violations. With this knowledge, we can learn from these violations and ensure that our metrology programs do not negatively impact the cost of quality of our organizations.


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CP_15_7A-NOWOCI
Picture of the productBest Practices in Validation of Automated Calibration Proc.
Suresh Ramachandran, National Instruments
Automated Calibration procedures are used commonly to perform complex calibrations in a cost effective manner. Automated calibration procedures when adopted, improve the efficiency of a calibration lab and also improve the quality of service provided. There are a number of software tools available in the market today that provides mechanisms for writing automated calibration procedures and these calibration procedures may be written by 3rd party software vendors or subcontractors for the lab. Adoption of automated calibration procedures for laboratory use requires the validation of the software to ensure accuracy and efficiency. This paper describes some of strategies and practices around validating automated software for measurement. This paper goes into some of the common testing methodologies that can be adopted to ensure that the software is adhering to measurement method that was described in the calibration procedure. This paper also touches on the need for configuration management and version control of the automated software updates for traceability and quality standards.


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CP_15_RAMACHAND
Picture of the productCalibrating Non-Automatic Weighing Instruments • Recent Dev.
Dr. Klaus Fritsch, Mettler-Toledo AG
The metrology of measuring instruments is a critical component of any organization’s quality operations. The standout prerequisite for traceable and accurate weighing is the effective calibration of weighing instruments, covered under the company's quality management system. It seems, however, that not all organizations have a thorough understanding of current metrological science. Unless specifically addressed by metrologists, it is still a widespread belief that calibrating a weighing instrument mainly consists of placing reference masses on the weighing platform with the objective to assess the deviation between the indication and the mass value of the reference. Not everybody is aware that calibration is a process that establishes a relation between quantity values provided by measurement standards and corresponding indications, which is only complete if the contributing measurement uncertainties are taken into account. On a national level, there are manifold calibration guidelines for weighing instruments, which are based on the concepts described in the Guide of the Expression of Uncertainty in Measurement (GUM). However, on a global level, only one document remains: The EURAMET calibration guideline cg-18 "Calibration of non-automatic weighing instruments". This document is currently under revision and might also act as a basis for a possible development of a US calibration guideline. This article focuses on the EURAMET cg-18 calibration guideline and its recent revision, specifically highlighting its practical implications for applications in the laboratory and the production area. One appendix that is added to the guideline introduces the so-called "minimum weight", i.e. the smallest sample quantity required for a weighment to just achieve a specified relative accuracy of weighing. The concept of minimum weight was also introduced during recent developments in the regulated industry in regards to the revision of the USP General Chapters 41 and 1251, thus also putting emphasis on key properties of weighing instruments that strongly affect the quality of weighing results.


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CP_15_7C-FRITSC
Picture of the productCalibration Interval Adjustment Methods
Mark Kuster,
Pantex Metrology
NCSLI Recommended Practice RP-1, “Establishment and Adjustment of Calibration Intervals,”
provides decision trees for selecting a calibration interval adjustment method based
on inventory size, available data, quality emphasis, and budgeting priorities. RP-1 also describes
each method’s pros and cons and offers qualitative recommendations based on expert
knowledge and experience. Since releasing the current RP edition, the NCSLI 173.1 Calibration
Intervals Working Group has sought to develop quantitative performance data on
interval adjustment methods to further substantiate or tune the existing recommendations.
Ultimately, the research will identify and map the optimal interval adjustment method into
each region of the operational space determined by equipment inventory size, reliability target,
and other parameters, enabling the future RP-1 reader to confidently select the most
appropriate method for the situation at hand. This paper reports the latest progress toward
that goal, including framework improvements such as AOPR and instrument lifetime simulation,
adjustment method parameter optimizations, and simulation results to date. We
compare results based on an excess relative cost metric, which estimates the cost premium an
interval adjustment method, or lack thereof, incurs in a measurement and testing program.


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CP_15_3C-KUSTER
Picture of the productCalibration of Defibrillator Analyzers at the HKSARG Stand.
Steven Yang and Aaron Y.K. Yan, Standards and Calibration Laboratory, The Government of the Hong Kong
The Standards and Calibration Laboratory (SCL) has set up calibration facility for the calibration of defibrillator and defibrillator analyzer. Defibrillators are medical devices designed to resume normal heart pulse of a patient by discharging energy pulse to a person who is suffering from an emergency cardiac attack. They are commonly used in hospitals and medical institutes. At the SCL, the energy delivered by a defibrillator is measured using a high quality digital sampling system. The system comprises a high voltage divider, a sampling voltmeter, an impedance analyzer and a control computer. The sampled voltage waveform is digitally processed to derive the delivered energy. The system can also be used to check the accuracy of a defibrillator analyzer. The sampling system and its signal processing are described in this paper. To ensure the accuracy of the sampling system, it is calibrated against the laboratory's voltage and time reference standards. A standard waveform with calculable energy is used to verify the sampling system. It is shown that the system can achieve an energy measuring accuracy of better than 0.7%.


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CP_15_3A-YANG
Picture of the productCalibration of Flicker Meters at the HKSARG Standards
Steven Yang, Aaron Y.K. and Yan, H. M. Chan, Standards and Calibration Laboratory, The Government of the Hong Kong
The Standards and Calibration Laboratory (SCL) has set up calibration facility for the calibration of flicker meters and sources. Flicker is a measure of the visual disturbance of the lighting system experienced by a human observer due to power supply fluctuation. It is in effect a measure of the voltage fluctuation of the power supply. Flicker meters are used to measure the amount of flicker. Flicker meters are calibrated by applying a voltage waveform with known fluctuation to the meter and comparing the meter's readings against the known voltage fluctuation values. Statistical analysis is then performed to the measured voltage fluctuation to obtain the short term flicker severity and the long term flicker severity. The applied waveform can either be a sinusoidal or a rectangular modulated waveform of the supply voltage. The modulation depth of the modulated waveform determines the flicker value. For sinusoidal modulation, the modulation depth can be determined by measuring the amplitudes of the carrier and the side bands. For rectangular modulation, the determination of the modulation depth is much more difficult. A novel measurement method is proposed using local maximum to find the global maximum and minimum of the modulating signal. Details of the flicker measurement system are described in the paper. The measured flicker severity has an expanded uncertainty of 0.3%.


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CP_15_9D-YANG
Picture of the productConformity Assessment of Energy Storage Systems
Vish Viswanathan, Pacific Northwest National Laboratory
Increasing energy, environmental, and economic challenges have heightened interest in developing and deploying new technologies related to energy delivery and use. Energy storage, including pumped hydropower systems and batteries, has been one of those technologies for some time. Utility programs, the need to respond to natural disasters, and policy changes have further increased interest in energy storage. Consequently energy storage technologies continue to grow in number, and their deployment is increasing on both the grid side and customer side of the meter. Energy storage system safety and performance is particularly important and criteria to define what is and is not safe and how these systems will perform are contained in a number of codes, standards, and regulations. The realization of safety and anticipated performance, as covered in codes, standards, and regulations, is heavily dependent on conformity assessment activities. These activities address the manner in which compliance with stated requirements is documented and verified and involves testing, certification, accreditation, and other activities by numerous parties. This paper provides background information about energy storage technologies and the documents that guide how their safety and performance are assessed. It also covers the role that testing, certification, and accreditation entities play in the timely deployment of safe energy storage systems and fostering informed decisions involving their anticipated performance.


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CP_15_3D-VISWAN
Picture of the productDimensional Metrology, Intermediate Precision and Uncertain.
Ted Doiron, National Institute of Standards and Technology
Uncertainty has proven difficult to implement in calibrations labs. The subject has advanced mathematics and statistics that are often needed for scientific research, but are seldom needed to develop uncertainty budgets for routine calibrations. There is, however, a second path to uncertainty that does not require such mathematical skills, only patience. This method, using check standards to sample the sources of variability is actually part of the GUM, albeit a small part.


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CP_15_3B-DOIRON
Picture of the productDo Your Measures Measure Up? Using Key Performance Indicator
Dean S. Williams, Duke Energy
We often think of measurements in terms of the physical. The SI system forms the basis for all our measurements. Or does it? While in the physical world this system of measurement holds sway, what about in the realm of managing our operations and businesses? Do we have a comparable Système International d'Unités for measuring operational effectiveness?

If we do have measures, are they measures that drive increased effectiveness or only document the tale of less than stellar past performance? This paper deals with how to identify, develop, and utilize Key Performance Indicators (KPIs) to drive greater operational effectiveness.


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CP_15_9A-WILLIA
Picture of the productEstablishment of the Gas Flow Calibration Facility at CSIR-N
Shiv Kumar Jaiswal, CSIR-National Physical Laboratory (NPLI)
Recently Gas Flow Calibration System (GFCS) has been established in the Fluid Flow Measurement Standard group of NPLI in the flow range from 10 sccm (standard cubic centimeter per minute) to 1000 slm (standard litre per minute) at 0 ºC and 101.325 kPa. The expanded measurement uncertainty of the system in the above flow range is ±0.2 % at k=2. This GFCS is suitable for calibration of different types of flowmeters i.e. mass flow controllers, mass flow meters, rotameters, totalizer type meters, digital flow calibrators, compact provers, etc used in many research, development and industrial applications mainly process controls, environmental monitoring, pharmaceuticals and drugs manufacturing, health assessment etc. and also in many NABL accredited laboratories. Present paper describes the details of the GFCS architecture and calibration of a rotameter (i.e. volumetric flow rate device) as a case study. The uncertainty has been estimated as per ISO ´GUM’ document guidelines [1]. The standards used for calibration are traceable to appropriate “National standards”


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CP_15_6D- JAISW
Picture of the productExploring the Relationship between Ambient Temperature and I
Logan Kunitz, National Instruments
This paper will explore issues regarding the relationship between a Device Under Test (DUT)’s internal temperature and the ambient temperature that is generally reported on a calibration report. What exactly is this ambient temperature representing, and how does this temperature relate to the temperature of the DUT? Is it the temperature of a single probe on the far corner of the lab? Is it the average of several probes throughout the lab? For DUTs that are enclosed in a force-air cooled chassis, the ambient temperature should probably represent the temperature at the intake fan for the chassis. However, the internal temperature of the device could be higher, but by how much? And, how much will the internal temperature vary over the course of a calibration, especially if the calibration takes multiple hours? How will an operator know if the internal temperature is too high, possibly due to clogged fan filters or other issues with air-flow? What about the effect of adjacent high-power instruments, causing the local temperature around the DUT to warm-up above the ambient level? If the DUT includes its own internal temperature sensor, how should this be used during calibration, and are there any situations where this temperature should be reported along with the ambient temperature?


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CP_15_8C-KUNITZ
Picture of the productHigh Voltage Divider Calibration with the Reference Step Met
Harold Parks, National Research Council Canada
High voltage DC measurements, from 10 kV up to several hundred kV, are usually traceable through resistive dividers which have a divider ratio on the order of 10 000 to 100 000. The reference step method [M.D. Early et al., IEEE Trans. Intsrum. Meas. 62, 1600 (2013)] provides a highly accurate ratiometric method of calibrating 1000 V calibrators across a wide range of voltages. We adapt this method for measuring the ratio of high voltage dividers at low (. 1000 V) voltages as a first step to establishing traceability at high voltages


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CP_15_7B-PARKS
Picture of the productHow Accreditation improve our quality of life?
I-Jhen Lin, Taiwan Accreditation Foundation (TAF)
Weights and balances are instruments commonly used in laboratories, industries and on the markets. The accuracy and precision of weights and balances would directly affect the data results as well as fair trade. As we know, the different calibration methods chosen by calibration laboratories usually cause different results on both measurement data and uncertainty analysis. In order to enhance the equivalence and mutual recognition of calibration results obtained by laboratories performing calibration of weights and balances, here, TAF (Taiwan Accreditation Foundation) provide an document called "Technical Criteria for Weights/Balances Calibration in Calibration Field" for our accredited laboratories. It gives general idea for the establishing of calibration procedures. The information presented in this document is intended to use as technical requirements for accredited calibration laboratories for performing weights/balances calibration and evaluating measurement uncertainty. In addition, the assessors of TAF should use this document as the basis for on-site assessment and laboratory accreditation.
The document contains basic requirements for the static calibration of weights and balances, such as calibration procedure including test of repeatability, error of indication, environmental condition, determination of the uncertainty of measurement, contents of calibration certificates, etc. For calibration laboratories, the uncertainty analysis is one of the important tasks for ISO/IEC 17025 laboratory accreditation. The evaluation results of uncertainty analysis, which perform in the calibration measurement capability (CMC) and scopes of accreditation, usually represent the capabilities and competence in measurement. Since all measurement have an associated uncertainty, it is crucial that the main parameters which can influence the quality of measurement result should be recognized. In order to reduce and identify possible errors, it is necessary to use correct calibration methods. Thus, some main parameters which should be recognized and included in the uncertainty budget also have been written in this document.


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CP_15_LIN
Picture of the productHow Effective is Self-Calibration in Precision DMMs
Gary Bennett, National Instruments
This paper shows the results of an evaluation of 7.5 and 8.5 digit DMMs where the ambient temperature was changed by up to five degrees. A few laboratories operate with environmental controls of ± 1°C, even more operate at ± 3°C, probably most operate at ± 5°C. Precision DMMs have specifications requiring a self-calibration each time the internal temperature changes by more than one degree when using them at their highest accuracy. Some DMMs don¡¦t have a self-calibration capability and the specifications change once the ambient temperature changes by more than 1 degree from the adjustment temperature. Some require that the self-calibration be within 5 degrees of the last adjustment temperature. These experiments tested the accuracy of several DMMs at different temperatures, with and without self-calibration to get an idea of what controls are required to keep the DMM within its most accurate specifications.


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CP_15_6B-BENNET
Picture of the productImproved Traceability And Reliability In Mass Calibration
Felix Mathis, Mettler Toledo AG
Mass calibration is a labour-intensive and multi-layered process. With manual data writing and limited quality control, final results may not comply with required quality standards. Interconnected equipment enables data security, data analysis and reporting in one system. Regulatory compliance is achieved with integrated uncertainty analysis, weighing schemes and quality control tools. This paper gives an insight to common mass calibration process hurdles and new solution approaches.


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CP_15_7C-MATHIS
Picture of the productInformation Based Interpretation for Reliability Goal
Ding Huang, US Naval Air Systems Command
Calibration intervals is derived based on conformity test results and a measurement reliability goal. A goal is written, such as, “Establish an objective end of period reliability goal for calibratable equipment equal to or greater than 85 percent, with the threshold reliability in no case to be lower than 72 percent.” There are two requirements 1. end-of-period reliability target no less than 85 percent, 2. establishing an end-of-period to achieve the target. For achieving the goal, it is a prerequisite to clarify how reliability probability is inferred. Measurement reliability could be interpreted in two diametrically different statistical foundations. By the Bayesian statistical inference, it expresses fundamentally logical inferences, pertaining to individual cases. Or, based on conventional statistical framework, it is associated with limiting frequency, corresponding to propensities affecting mass phenomena. This essay discusses and recommends reliability requirement specify the accuracy associated with the end-of-period reported. Due to incomplete information, there will always be an uncertainty associated with the best reported end-of-period. Examples of small sample sizes are provided to demonstrate measurement reliability management for supporting the requirement. In a sense, this topic is even more fundamental to science • for what the theoretically valid and pragmatically useful ways to apply probability theory in science.


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CP_15_HUANG
Picture of the productInsight into the APLAC Member Survey on Report Credibility
Wanji C. J. Yang, Taiwan Accreditation Foundation
This article describes the analysis of a member survey conducted by the Asia Pacific Laboratory Accreditation Cooperation (APLAC) on test and inspection report credibility. This survey was the very first survey on this issue amongst accreditation bodies (ABs). The subject of this survey was first conceived during a meeting of APEC TEL MRA Task Force in 2012, when telecommunications regulators from several economies expressed concerns about counterfeit report issues. The APLAC Board of Management later decided to initiate a survey to collect information and opinions from its full members, as the starting point of addressing these concerns and help members share experience. The survey was conducted during 21 July 2014 to 20 August 2014, and the analysis results were subsequently presented at meetings of APEC TEL50 and ILAC/IAF meeting in 2014.


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CP_15_2B-YANG
Picture of the productInstrument Adjustment Policies
Paul Reese, Baxter Healthcare Corporation
Instrument adjustment policies play a key role in the reliability of calibrated instruments to maintain their accuracy over a specified time interval. Periodic review and adjustment of assigned calibration intervals is required by national standard ANSI/NCSL Z540.3 and is employed to manage the End of Period Reliability (EOPR) to acceptable levels. Instrument adjustment policies may also be implemented with various guardband strategies to manage false accept risk. However, policies and guidance addressing the routine adjustment of in-tolerance instruments are not so well established. National and international calibration standards ANSI/NCSL Z540.3 and ISO/IEC-17025 do not mandate any particular adjustment policy with regard to in-tolerance equipment. Evidence has been previously presented where routine adjustment of in-tolerance items may even degrade performance. Yet, this important part of the overall calibration process is often left to the discretion of the calibrating technician based on heuristic assessment. Astute adjustment decisions require knowledge of the random vs. systematic nature of instrument error. Instruments dominated by systematic effects, such as drift, benefit from adjustment, while those displaying more random behavior may not. Monte Carlo methods are used here to investigate the effect of various adjustment thresholds on in-tolerance instruments.


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CP_15_3C-REESE
Picture of the productInter Laboratory Comparison (ILC) • 10 dB attenuator stan.
Major René Pracht, Wehrtechnische Dienststelle für Informationstechnologie und Elektronik
NATO Military forces are in constant need for standardization of material and logistic behavior in order to improve their interoperability. Calibration as part of the logistic management of test and measurement equipment contains the opportunity to perform a comparison of the capabilities and the degree of equivalence between many international participant laboratories based on the same technical needs but not necessarily the same technical equipment. Starting in 2012 the Calibration Organization of the German Armed Forces organized an ILC with an 10 dB attenuator standard. German Armed Forces Calibration Center analyzed the data and prepared a final report.


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CP_15_PRACHT
Picture of the productInternal Auditing • More Than Compliance
Guy G. Robinson, Tektronix, Inc
A well-developed and executed internal audit program is flexible and allows for assessment of an organization’s compliance to multiple international standards on a continuous basis, not just during the process of initial assessment or renewal by external accreditation or registration bodies.

A robust internal audit program with trained and experienced Quality Engineers is a scalable process and can pay significant dividends to a calibration/test organization by doing more than just meeting the internal audit requirements of external accrediting bodies.


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CP_15_9A-ROBINS
Picture of the productIs Instrument Interchangeability in Calibration Just a Dream
Logan Kunitz, National Instruments
As instruments steadily get more complicated, manual calibrations become less feasible. Many laboratories are too small to write full, automated solutions for calibration, so it is common for solutions for automated calibration to be used by many laboratories. However, each laboratory has a different set of standards that they can use for calibrations, so these automated solutions should be able to handle different instruments that can be used interchangeably. In other words, they should support ´instrument interchangeability’. This paper will examine some of the use cases that should be handled by these calibration solutions along with the difficulties that arise in attempts to solve them.


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CP_15_KUNITZ