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Simulation Model Calibration and Validation: Phase II

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The Quality Calibration Handbook

Also Available from ASQ Quality Press: The Metrology Handbook Jay L



and Attribute Measurement System Work for You William D

Mawby ANSI/ISO/IEC 17025-2005: General requirements for the competence of testing and calibration laboratories ANSI/ISO/IEC ANSI/ISO/ASQ Q10012-2003: Measurement management systems—Requirements for measurement processes and measuring equipment ANSI/ISO/ASQ The Uncertainty of Measurements: Physical and Chemical Metrology: Impact and Analysis S

Kimothi Managing the Metrology System,

Third Edition C

Robert Pennella Get It Right: A Guide to Strategic Quality Systems Ken Imler Integrating Inspection Management into Your Quality Improvement System William D

Mawby Failure Mode and Effect Analysis: FMEA from Theory to Execution,

Second Edition D

Stamatis Root Cause Analysis: Simplified Tools and Techniques,

Second Edition Bjørn Andersen and Tom Fagerhaug The Certified Manager of Quality/Organizational Excellence Handbook: Third Edition Russell T


editor Leadership for Results: Removing Barriers to Success for People,


and Processes Tom Barker To request a complimentary catalog of ASQ Quality Press publications,

call 800-248-1946 or visit our Web site at http://qualitypress

The Quality Calibration Handbook Developing and Managing a Calibration Program

ASQ Quality Press Milwaukee,


American Society for Quality,

Quality Press,

Milwaukee 53203 © 2007 American Society for Quality All rights reserved

Published 2006 Printed in the United States of America 12 11 10 09 08 07 06

Library of Congress Cataloging-in-Publication Data Bucher,

Includes bibliographical references and index

ISBN 0-87389-704-8 (casebound : alk



Quality assurance—Handbooks,

B75 2006 658



ISBN–10: 0–87389–704–8 ISBN–13: 978–0–87389–704–4 No part of this book may be reproduced in any form or by any means,

without the prior written permission of the publisher

Publisher: William A

Tony Acquisitions Editor: Matt Meinholz Project Editor: Paul O’Mara Production Administrator: Randall Benson ASQ Mission: The American Society for Quality advances individual,

and community excellence worldwide through learning,

Attention Bookstores,



and Corporations: ASQ Quality Press books,

and software are available at quantity discounts with bulk purchases for business,

For information,

please contact ASQ Quality Press at 800-248-1946,

or write to ASQ Quality Press,

Box 3005,


WI 53201-3005

To place orders or to request a free copy of the ASQ Quality Press Publications Catalog,

including ASQ membership information,

Visit our Web site at www

Printed on acid-free paper


List of Figures and Tables



Why Calibration Is Critical

Chapter 1 Preventing the Next Great Train Wreck

Chapter 2 Requirements and Standards—What They Really Say

Part II

The Basics of a Quality Calibration System

Chapter 3 The Basics

Chapter 4 Calibration Procedures

Chapter 5 Calibration Records

Chapter 6 It’s Out of Tolerance—Now What

Chapter 7 Calibration Standards

Chapter 8 Traceability

NIST Policy on Traceability

Chapter 9 Uncertainty

Measurement System Analysis—MSA

Uncertainty Calculator

System File

What Does the Crystal Ball Show for the Future

Chapter 10 Calibration Labels

Part III

Developing a Quality Calibration Program

Chapter 11 Meeting Your Needs and Requirements

Chapter 12 Calibration Environment

Chapter 13 Calibration Scheduling

Chapter 14 Calibration Software

Chapter 15 Calibration Intervals

Part IV

Managing a Quality Calibration Program

The Last Frontier


Chapter 19 Chapter 20

The Audit

167 Index

Figures and Tables

Figure 5

1 Figure 5

2 Figure 5

3 Figure 5

4 Figure 5

5 Figure 5

6 Figure 6

1 Figure 6

2 Figure 6

3 Table 7

1 Table 7

2 Table 7

3 Figure 8

1 Figure 8

2 Table 9

1 Figure 9

1 Table 9

2 Table 9

3 Figure 9

2 Figure 9

3 Figure 9

5 Table 12

1 Table 12

2 Table 15

1 Table 15

Sample calibration system computer folder

Sample calibration form

Sample calibration form

Using routers or hubs to set up a system

Julian date calendar

Julian date calendar for leap years

Sample out-of-tolerance notification form

Out-of-tolerance tracking database

SI derived units

SI prefixes

Definitions of various types of standards

Traceability pyramid

Traceability pyramid

Confidence interval values and associated k values

Accuracy versus precision

Weight requirements to meet prescribed tolerances

Example for finding the lowest mass that can be weighed

Opening screen

First-time user screen 1

First-time user screen 2

Samples of calibration labels

Samples of limited calibration labels

Samples of Do Not Use labels

Samples of Calibration Not Required labels

Sample Standardize Before Use and Calibrate Before Use labels

General-purpose calibration laboratories

Standards calibration laboratories,

or higher-accuracy requirements

Sample acceptable limit range

Five-year average pass rate

Adjustable pipettes

Workload forecast

Short-cycled workload forecast


an initially invented the wheel long before records were officially kept or written down

Yet it is very possible that variations on the wheel were reinvented,

If records had been kept for all to access,

and they were available when needed,

less invention might have taken place,

and more “improvement” could have taken place

The same can be said for calibration

The good folks in the metrology and calibration fields have been inventing ways to calibrate (calibration systems vice calibration of a particular item) for as long as I can remember,

and that goes back to 1971 when I started my career in metrology and calibration

Each branch of the military has its way of performing calibrations

Each third-party calibration lab has its way,

along with each department or calibration function within most companies throughout the world

When all is said and done,

is there one formal way to calibrate

because there are many factors that go into putting together a calibration system,

most depending on what standards or regulations govern the calibration function


is there one triedand-true quality calibration system that every organization can use as a foundation for its personalized program

That is where The Quality Calibration Handbook comes in

By using the quality calibration system outlined and demonstrated here,

any organization can put together its own version to meet its specific requirements and/or regulations

Organizations can avoid having to completely reinvent the critical wheel called calibration

But we’re getting ahead of ourselves

we have to define what calibration is and what it is not

In 1998,

during an initial audit for ISO 9001,

experienced auditor was inspecting a metrology department

While reviewing some of the calibration records,

the auditor continued to refer to calibration as the adjustment of the test equipment

She said that the liquid-in-glass (LIG) thermometer could not be calibrated because it could not be adjusted

Her audit contained three instances of this type of statement

I tried to remain as patient and sympathetic of her ignorance as humanly possible (there have been times in the past when I have not been known for extreme patience)

After the referral about the LIG thermometer,

there was no choice but to educate the auditor about the real meaning of calibration

The department manager,

company management representative,

and others in attendance all took a deep breath and held it

They thought there was never a time ix

Under most circumstances,

But I could not allow her to be totally incorrect in how she did her job in this circumstance

I explained to the auditor—using the VIM and NCSLI definitions and examples from those definitions—what calibration really meant

She said she would make a note of the true definition so other auditors could be educated,

and she was grateful for the education

In that case,

There were no findings,

More information can be found in Chapter 20 on how to work with auditors

There is also advice for what to say or not say during audits

Eight years later,

during a meeting with the regional sales representative of a test equipment company,

a very similar incident happened

We had owned their products for several years,

calibrated them on a yearly basis,

and decided to upgrade to a new version of the product

A sit-down demonstration was arranged

The first statement from the salesman was,

“The new version of the software allows calibration of these items

” I apologized and said that we have been calibrating our older models for years

He said that was not possible because the previous versions of software did not allow for any type of adjustment

I explained what calibration really meant,

and he looked at me like I had grown horns

It would appear the word still has not gotten out about the true meaning of calibration

The following primary and secondary definitions are according to VIM 6

also known by the French title,

Vocabulaire international des termes foundamentaux et généraux de métrologie (VIM)] and NCSL International (pp

It is the process of verifying the capability and performance of an item of measuring and test equipment by comparison to traceable measurement standards

Calibration is performed with the item being calibrated in its normal operating configuration—as the normal operator would use it

The calibration process uses traceable external stimuli,

or artifacts as needed to verify the performance

Calibration provides assurance that the instrument is capable of making measurements to its performance specification when it is correctly used

The result of a calibration is a determination of the performance quality of the instrument with respect to the desired specifications

This may be in the form of a pass/fail decision,

determining or assigning one or more values,

or the determination of one or more corrections

The calibration process consists of comparing test equipment with specified tolerances but of unverified accuracy,

to a measurement system or device of specified capability and known uncertainty,

or minimize by adjustment any deviations from the tolerance limits or any other variation in the accuracy of the instrument being compared

Calibration is performed according to a specified documented calibration procedure,

under a set of specified and controlled measurement conditions,

and with a specified and controlled measurement system

Preface xi

Many manufacturers [auditors,

QA inspectors,

and so on] INCORRECTLY use the term calibration to name the process of alignment or adjustment of an item that is either newly manufactured or is known to be out of tolerance,

or is otherwise in an indeterminate state

Many calibration procedures in manufacturers’ manuals are actually factory alignment procedures that need to be performed only if a UUC (unit under calibration) is in an indeterminate state because it is being manufactured,

is known to be out of tolerance,

When used this way,

calibration means the same as alignment or adjustment,

which are repair activities and excluded from the metrological definition of calibration

Here is the bottom line when it comes to what calibration is: A comparison of test equipment with an unknown uncertainty to a standard with a known uncertainty

Calibration is the comparison of a piece of test equipment with a standard,

regardless of whether the standard is kept at NIST

It is the reference standard used by a third-party calibration lab or the working standard used every day by calibration technicians

It is a comparison

You need something to calibrate and a standard to compare it against

Calibration has nothing to do with adjustment,

All of these can be incorporated into the process at some point,

depending on what the item is,

at what level it is being calibrated

Here are some quick thoughts about alternative titles for this book: Calibration—How to Make Friends and Scare the Hell Out of Your Competition Calibration—No Fat,

No Sugar,

No Calories

Nothing but Profit Calibration—It’s No Longer a Dirty Word Calibration or Bust

! If it seems that I am excited about this book,

I am excited about calibration and metrology,

and how they impact our quality of life

I want to shout it from the mountaintops,

splash it across newspaper pages,

and discuss nothing else with family and friends

Of course,

that would get boring to the uninitiated,

or to everyone who does not understand how critical calibration is to everything around us

I have to temper my enthusiasm and write a book about it

Part of the reason for writing a book about calibration is to educate the general public about the great need for a quality calibration system

One of the distinguished reviewers of this book’s original abstract was so bold as to pontificate: “Simply stated,

But in all fairness,

there isn’t much pizzazz to be found in discussing calibration systems

” Nothing could be further from the truth

Here is what a few calibration technicians might have to say about the impact their jobs have on our overall quality of life: • The equipment I calibrate on a daily basis helps catch killers and rapists all across America

• My work was instrumental in helping to set the innocent free from prison

• Airline accidents and mishaps are down in direct proportion to the accuracy of my work

• The highways and byways are safer because of the due diligence of our calibration program in automotive manufacturing


• The number of people helped by the medications we manufacture using calibrated systems and measurements is incalculable

• There are more new discoveries in drugs and cures for the incurable than ever before,

in part thanks to the repeatable readings and accuracy of our calibrated test equipment

How is all of this possible

? Quality calibration systems are the foundation for improving research and development (R&D),

and quality assurance arenas through accurate,

and traceable calibrations of their test equipment

If quality calibration were not important,

then it would not be a requirement in industry,

I help catch killers and rapists,

all the while aiding in setting the innocent free

I do this every day

My cohorts,

other calibration practitioners,

do similar life-saving work to prevent air disasters,

How is this possible

? By my ensuring the calibration of test equipment used in the production of genetic identity kits used by law enforcement at crime scenes,

the guilty are often caught and the innocent exonerated

Calibrated test equipment used in support of the airline and automotive industries helps prevent disasters

While calibration technicians do their seemingly boring,

mundane jobs at the nation’s pharmaceutical companies,

they are quietly laying the foundation for quality treatments that keep all of us healthy and help cure diseases and sometimes prevent death

Not much pizzazz in any of that

? It’s time someone woke up and smelled the coffee

This book explains why a quality calibration system can be the difference between life and death,

and—most important to shareholders and boards of directors—profit and loss


The Metrology Handbook (Milwaukee: ASQ Quality Press,


would like to express my thanks to my father and mother

Even though they both passed away several years ago,

their influence and work ethics have kept me in good stead these many years

Most of us don’t appreciate our parents until after we lose them,

I was fortunate to have known ahead of time that they were special

My dad only had a ninth-grade education,

but through hard work and a continuing desire to learn,

He shared his knowledge,

and wisdom with family and friends

I’m hoping to emulate him in a small way by writing this book



for the great example to follow

I’d also like to thank Lou Mezei,

senior scientific fellow and computer programmer extraordinaire,

and drive to excel at any task

I’ve said it many times,

” Lou has the ability to take any problem,

or project and produce an end result second to none

Not only is the final result better than what was requested,

but future requirements and objects are automatically added to preclude having to reinvent the wheel somewhere down the line

It is indeed a privilege to observe a true genius in action


for allowing this old Minnesota hog farmer to watch you in action

Thanks also go out to William A

president/CEO of Promega Corporation,

for giving me the opportunity to work and play at his company

It is a privilege to work in an organization that stays on the cutting edge of innovation and technology

It keeps the rest of us on our toes,

motivating us to keep discovering new and better ways to do our jobs

I suppose the best I can say in just a few words is: It’s a great place to work

At least it is for Team Metrology and me

Speaking of Team Metrology,

Keela and Karl

Your help and support through the years and with this book have given me a brighter light,

not only to see where I’m going,

to see the best way to get there

Together we have jumped many hurdles,

found new and better ways to get the job accomplished,

and still found time for the occasional laugh and ice cream

You bring new meaning to our motto of providing quality service in a timely manner

Without either one of you,

!” I feel privileged to call both of you friends

And thanks to the Fischbecks

Bob “Oyabun,” for giving my wife the opportunity of a lifetime

It brought us to “’Sconsin” and helped to open so many doors we had to move to a bigger house

Thanks also to Pat,

the greatest innkeeper in the world,

for your friendship and for expanding my exposure to authors of historical romance novels

I must thank my family for their patience,

They stood by me through thick and thin,

and never let me doubt what I was doing or why I was doing it

Both of you keep me young at heart and constantly on my toes

To have the love and respect of my daughter and wife is something I have to work at every single day

I don’t take that for granted,

As the lyrics from Spiral Starecase say,

“I love you more today than yesterday,

” To all the calibration technicians,

Air Force,


thank you for doing what you do to help keep our great country second to none

I know from personal experience that you seldom receive thanks or appreciation for doing the mundane and repetitive tasks that eventually result in somebody else getting credit for a job well done

Accuracy and precision still have their place and all of you,

ensure the job is done right the first time

“Close enough for government work” is still not part of your mantra—thank God

! I hope this book helps a few of you realize that if you have only served for a few years or an entire career,

Godspeed to all our brothers and sisters serving in the military




Part I Why Calibration Is Critical

during the annual Measurement Science Conference (MSC),

held at the Disneyland Convention Center in Anaheim,


the Measurement Quality Division (MQD) sponsored a seminar on metrology education

During that seminar,

one of the audience participants was Dr

Klaus-Dieter Sommer of Germany

Sommer explained that he was a guest professor at a university in China

He told how the university had an input of 8,000 students every year,

and they were all studying measurement techniques within a metrology system

He said the Chinese government has increased their attendance to around 12,000 students in metrology and measurement techniques

His question then was,

“Why doesn’t the United States and/or Germany train and educate in the field of metrology and calibration they way the Chinese are doing

?” After one person gave their ideas,

I had an epiphany

I raised my hand and answered,

“Because we haven’t had the great train wreck yet

” We haven’t had a train wreck where someone says,

“Calibration was the problem

” We haven’t had the train wreck where there is a great loss of life or limb,

or many businesses go bankrupt,

or a great many people lose their livelihood or retirement funds

The automotive industry has had many train wrecks

We all remember the problems that Ford Motor Company and Firestone had a few years ago

The airline industry has had many instances of tragedy and loss of life over the years

The nuclear industry has had its fair share of problems,

Without calibration,

or by using incorrect calibrations,

all of us pay more at the gas station,

for food weighed incorrectly at the checkout counter,

Incorrect amounts of ingredients in your prescription and over-the-counter (OTC) drugs can cost more,

or even cause illness or death

Because of poor or incorrect calibration,

killers and rapists are either not convicted or are released on bad evidence

Crime labs cannot identify the remains of victims or wrongly identify victims in the case of mass graves

Airliners fly into mountaintops and off the ends of runways because they don’t know their altitude and/or speed

Babies are not correctly weighed at birth

The amount of drugs confiscated in a raid determines whether the offense is a misdemeanor or a felony

? Errors in calibration can effect the automotive,

They can also have an impact on how long or wide a 2  4 is,

not to mention the thickness of drywall,

how much radiation is emitted by a microwave oven,

overcharged each month because your gas meter is turning at the wrong speed,

or how much extra a company pays for their stamps because the scale at the post office adds 5 percent to package weight

No more watching your favorite television shows or listening to your favorite songs or talk radio,

because due to calibration errors,

the frequency would be off enough that TVs and radios would be useless

Satellites and everything they affect would be a thing of the past,

as would be the manufacturing and production of almost everything made in the world today

The United States Food and Drug Administration (FDA),

an agency that protects the health of the American people,

is one of the most successful and proudest creations of the American democracy

The FDA was created in the early 20th century amid revelations about filth in the Chicago stockyards that shocked the nation into the awareness that in an industrial economy,

protection against unsafe products is beyond any individual’s means

Congress responded to Upton Sinclair’s best-selling The Jungle by passing the Food and Drugs Act of 1906,

which prohibited interstate commerce in misbranded and adulterated food and drugs

Enforcement of the law was entrusted to the U

Department of Agriculture’s Bureau of Chemistry,

The act was the first of more than 200 laws that constitute one of the world’s most comprehensive and effective networks of public health and consumer protections

Here are a few of the congressional milestones: • The Federal Food,

and Cosmetic (FD&C) Act of 1938 was passed following the death of 107 people,

who took a legally marketed poisonous elixir of sulfanilamide

The FD&C Act completely overhauled the public health system

Among other provisions,

the law authorized the FDA to demand evidence of safety for new drugs,

and conduct factory inspections

• The Kefauver-Harris Amendments of 1962,

spurred by the thalidomide tragedy in Europe (and the FDA’s vigilance that prevented the drug from being marketed in the United States),

strengthened the rules for drug safety and required manufacturers to prove their drugs’ effectiveness

• The Medical Device Amendments of 1976 followed a U

Senate finding that faulty medical devices had caused 10,000 injuries,

The law applied safety and effectiveness safeguards to new devices

the FDA regulates an estimated $1 trillion worth of products a year

It ensures the safety of all food except for meat,

ensures the safety and effectiveness of all drugs,

biological products (including blood,

and tissues for transplantation),

and makes sure that cosmetics and medical and consumer products that emit radiation do no harm

Until there is,

people will not realize that they need a quality calibration system

it is even more important that we be proactive in our application of quality calibration programs

If industry waits for the great train wreck,

The pendulum will swing too far and we will have to abide far more government control than is needed

Recent history provides myriad examples of the need

Hurricanes were killing hundreds of people along the gulf coast

Area residents needed more advance notice to help with timely evacuations

Hurricane hunters,

Chapter 1 Preventing the Next Great Train Wreck 5

advanced radar have greatly increased the time we have to see and try to predict hurricane paths

As mentioned previously,

the FDA came about because of the pain and suffering of many people

Their system has evolved into one of the toughest to pass among any of our auditing agencies,

The FDA makes decisions that affect public safety

Generally speaking,

one should know where they are going before they start any journey

One should know what a building is going to be used for before actually constructing it

For example,

a high-tech warehouse would not do a dairy farmer much good,

a state-of-the-art dairy barn would not do a distribution facility any good

The same can be said about a quality calibration system

Is there a need

? What does a company gain by implementing a quality calibration system

and private companies worldwide would agree

government regulates to the extent that about 22 percent of all industry in the United States falls under FDA guidelines,

which are very specific about the requirements for documented,

traceable calibrations (see Chapter 2 for details)

All ISO standards have a requirement for calibration when test equipment is involved

The requirements for calibration in other industries such as automotive,

and manufacturing are well known throughout their industries

In other words,

humankind’s need to measure has been around for generations

that need has been and continues to be addressed in a variety of ways

Humankind understandably turned first to parts of its body and natural surroundings for measuring instruments

Early Babylonian and Egyptian records and the Bible indicate that length was first measured with the forearm,

or finger and that time was measured by the periods of the sun,

When it was necessary to compare the capacities of containers such as gourds or clay or metal vessels,

they were filled with plant seeds,

which were then counted to measure the volume

When means for weighing were invented,

seeds and stones served as standards

For instance,

still used as a mass unit for gems,

was derived from the carob seed

As societies evolved,

measurement units became more complex

The invention of numbering systems and the science of mathematics made it possible to create whole systems of measurement units suited to trade and commerce,

For these more sophisticated uses it was necessary not only to weigh and measure more complex things,

it was also necessary to do it accurately time after time and in different places


with limited international exchange of goods and communication of ideas,

it is not surprising that different systems for the same purpose developed and became established in different parts of the world—even in different parts of a single continent

The measurement system commonly used in the United States today is nearly the same as that brought by the colonists from England

These measures had their origins in a variety of cultures—Babylonian,



The ancient digit,

and cubit units evolved into the inch,

and yard through a complicated transformation not yet fully understood

Roman contributions include the use of the number 12 as a base (our foot is divided into 12 inches) and words from which we derive many of our present measurement unit

For example,

the 12 divisions of the Roman pes,

Our words inch and ounce are both derived from that Latin word

The yard as a measure of length can be traced back to the early Saxon kings

They wore a sash or girdle around the waist that could be removed and used as a convenient measuring device

Thus the word yard comes from the Saxon word gird,

meaning the circumference of a person’s waist

Standardization of the various units and their combinations into a loosely related system of measurement units sometimes occurred in fascinating ways

Tradition holds that King Henry I decreed that the yard should be the distance from the tip of his nose to the end of his thumb

The length of a furlong (or furrow-long) was established by early Tudor rulers as 220 yards

This led Queen Elizabeth I to declare,

that henceforth the traditional Roman mile of 5,000 feet would be replaced by one of 5,280 feet,

making the mile exactly eight furlongs and providing a convenient relationship between two previously ill-related measures

By the 18th century,

England had achieved a greater degree of standardization than the continental countries

English units were well-suited to commerce and trade because they had been developed and refined to meet commercial needs

Through colonization and dominance of world commerce during the 17th,

the English system of measurement units was spread to and established in many parts of the world,

including the American colonies


standards still differed to the extent that they were undesirable for commerce among the 13 colonies

The need for greater uniformity led to clauses in the Articles of Confederation (ratified by the original colonies in 1781) and the Constitution of the United States (ratified in 1790) giving power to the Congress to fix uniform standards for weights and measures

standards supplied to all the states by the National Institute of Standards and Technology (NIST) ensure uniformity throughout the country

and/or continuously improve a quality calibration system,

with all the required documentation,

and known uncertainty for each and every item of test equipment owned and used by any company,

If a business expects to be a player in their market segment,

their product must have the quality expected by their customers

This can be accomplished only with test equipment that produces repeatable,

and traceable measurements and/or outputs

Without a quality calibration system in place,

this cannot and will not happen

This book will benefit companies that want to implement a program and companies that already have an established program in place

Some industries have tighter requirements than others on how they treat calibration

Some are more specific about how their standards are read,

while being vague about what is needed to meet calibration

Keeping this in mind,

this book has been written to meet or exceed these requirements

It does not cost any more to put together a first-class program than it does to put together a ragged-edge one

Both need documentation,

to name a just a few requirements

And every program needs to continually improve whatever process they have in place on a regular basis

How can the average calibration technician make an impact within an organization

? Are they just another cog in the wheel of industry

I believe calibration technicians

Chapter 1 Preventing the Next Great Train Wreck 7

can have a significant impact on the bottom line of any company and be instrumental in product development,

all through their knowledge of the test equipment that is used in their company

They have a perspective of what works and what doesn’t at the ground floor where decisions are made

Their inputs and analysis can make the difference between success and failure of product,


“FDA Protects the Public Health

Ranks High in Public Trust,” February 2002

gov/ opacom/factsheets/justthefacts/1fda

“A Brief History of Measurement Systems,” 15 September 1999

edu/schools/ hum_sci/physics/tutor/2210/measurements/history


Important: Terms that are not in this glossary may be found in one of these primary references: International Vocabulary of Basic and General Terms in Metrology (called the VIM)

Geneva: ISO,

ANSI/NCSL Z540-2-1997,

Guide to the Expression of Uncertainty in Measurement (called the GUM)


CO: NCSL International,

NCSL Glossary of Metrology-Related Terms,

Second edition


CO: NCSL International,

Some terms may be listed in this glossary in order to expand on the definition,

but should be considered an addition to the references listed above,

(It is assumed that a calibration or metrology activity owns copies of these as part of its basic reference material

it is important to correctly use words that have a technical meaning

Definitions of these words are in relevant national,

journals and other publications,

as well as publications of relevant technical and professional organizations

Those documents give the intended meaning of the word,

so everyone in the business knows what it is

In technical work,

only the technical definitions should be used

Many of these definitions are adapted from the references

In some cases,

several may be merged to better clarify the meaning or adapt the wording to common metrology usage

The technical definitions may be different from the definitions published in common grammar dictionaries


the purpose of common dictionaries is to record the ways that people actually use words,

not to standardize the way the words should be used

If a word is defined in a technical standard,

its definition from a common grammar dictionary should never be used in work where the technical standard can apply

GLOSSARY (FROM THE METROLOGY HANDBOOK) accreditation (of a laboratory)—Formal recognition by an accreditation body that a calibration or testing laboratory is able to competently perform the calibrations or tests listed in the accreditation scope document

Accreditation includes evaluation of both the quality management system and the competence to perform the measurements listed in the scope

accreditation body—An organization that conducts laboratory accreditation evaluations in conformance to ISO Guide 58

accreditation certificate—Document issued by an accreditation body to a laboratory that has met the conditions and criteria for accreditation

The certificate,

with the documented measurement parameters and their best uncertainties,

serves as proof of accredited status for the time period listed

An accreditation certificate without the documented parameters is incomplete

accreditation criteria—Set of requirements used by an accrediting body that a laboratory must meet in order to be accredited

accuracy (of a measurement)—A qualitative indication of how closely the result of a measurement agrees with the true value of the parameter being measured

accuracy of a measurement is always an estimate

An accuracy statement by itself has no meaning other than as an indicator of quality

It has quantitative value only when accompanied by information about the uncertainty of the measuring system

Contrast with: accuracy (of a measuring instrument) accuracy (of a measuring instrument)—A qualitative indication of the ability of a measuring instrument to give responses close to the true value of the parameter being measured

Contrast with: accuracy (of a measurement) assessment—An examination typically performed on-site of a testing or calibration laboratory to evaluate its conformance to conditions and criteria for accreditation

best measurement capability—For an accredited laboratory,

“the smallest uncertainty of measurement a laboratory can achieve within its scope of accreditation when performing more-or-less routine calibrations of nearly ideal measurement standards intended to define,

or reproduce a unit of that quantity or one or more of its values

or when performing more-or-less routine calibrations of nearly ideal measuring instruments designed for the measurement of that quantity

” [EA-4/02] The best measurement capability is based on evaluations of actual measurements using generally accepted methods of evaluating measurement uncertainty

bias—The known systematic error of a measuring instrument

Adding a correction,

which is always the negative of the bias,

See also: correction,

systematic error calibration (1)—(See VIM 6

) A term that has many different—but similar—definitions

It is the process of verifying the capability and performance of an item of measuring and test equipment by comparison to traceable measurement standards

Calibration is performed with the item being calibrated in its normal operating configuration—as the normal operator would use it

The calibration process uses traceable external stimuli,

or artifacts as needed to verify the performance

Calibration provides assurance that the


instrument is capable of making measurements to its performance specification when it is correctly used

The result of a calibration is a determination of the performance quality of the instrument with respect to the desired specifications

This may be in the form of a pass/fail decision,

determining or assigning one or more values,

or the determination of one or more corrections

The calibration process consists of comparing an IM&TE unit with specified tolerances but of unverified accuracy to a measurement system or device of specified capability and known uncertainty in order to detect,

report or minimize by adjustment any deviations from the tolerance limits or any other variation in the accuracy of the instrument being compared

Calibration is performed: according to a specified documented calibration procedure,

under a set of specified and controlled measurement conditions,

and with a specified and controlled measurement system

A requirement for calibration does not imply that the item being calibrated can or should be adjusted

The calibration process may include,

calculation of correction factors or adjustment of the instrument being compared to reduce the magnitude of the inaccuracy

In some cases,

minor repair such as replacement of batteries,

or minor adjustment such as zero and span,

may be included as part of the calibration

Calibration does not include any maintenance or repair actions except as noted above

See also: performance test,

Contrast with: calibration (2) and repair calibration (2)—Many manufacturers incorrectly use the term “calibration” to name the process of alignment or adjustment of an item that is either newly manufactured or is known to be out of tolerance,

or is otherwise in an indeterminate state

Many “calibration” procedures in manufacturers’ manuals are actually factory alignment procedures that only need to be performed if a UUC is in an indeterminate state because it is being manufactured,

is known to be out of tolerance,

When used this way,

“calibration” means the same as alignment or adjustment,

which are repair activities and excluded from the metrological definition of calibration

In many cases,

IM&TE instruction manuals may use “calibration” to describe tasks normally performed by the operator of a measurement system

Examples include performing a self-test as part of normal operation,

or performing a self-calibration (normalizing) a measurement system before use

When “calibration” is used to refer to tasks like this,

the intent is that they are part of the normal work done by a trained user of the system

These and similar tasks are excluded from the metrological definition of calibration

Contrast with: calibration (1)

standardization calibration activity or provider—A laboratory or facility—including personnel—that perform calibrations in an established location or at customer location(s)

It may be external or internal,

including subsidiary operations of a larger entity

It may be called a calibration laboratory,

or a metrology laboratory or department,

or any combination or variation of these

calibration certificate—A calibration certificate is generally a document that states that a specific item was calibrated by an organization

The certificate identifies the item calibrated,

the organization presenting the certificate,

A calibration

certificate should provide other information to allow the user to judge the adequacy and quality of the calibration

In a laboratory database program,

a certificate often refers to the permanent record of the final result of a calibration

A laboratory database certificate is a record that cannot be changed

if it is amended later a new certificate is created

See also: calibration report calibration procedure—A controlled document that provides a validated method for evaluating and verifying the essential performance characteristics,

or tolerances for a model of measuring or testing equipment

A calibration procedure documents one method of verifying the actual performance of the item being calibrated against its performance specifications

It provides a list of recommended calibration standards to use for the calibration,

a means to record quantitative performance data both before and after adjustments,

and information sufficient to determine if the unit being calibrated is operating within the necessary performance specifications

A calibration procedure always starts with the assumption that the unit under test is in good working order and only needs to have its performance verified

Note: A calibration procedure does not include any maintenance or repair actions

calibration program—A process of the quality management system that includes management of the use and control of calibrated inspection,

and measuring equipment (IM&TE)

the process of calibrating IM&TE used to determine conformance to requirements or used in supporting activities

A calibration program may also be called a measurement management system (ISO 10012:2003)

calibration report—A document that provides details of the calibration of an item

In addition to the basic items of a calibration certificate,

a calibration report includes details of the methods and standards used,

and the actual measurement results and uncertainty

See also: calibration certificate calibration seal—A device,

when removed or tampered with,

and by virtue of its design and material,

The purpose of a calibration seal is to ensure the integrity of the calibration

A calibration seal is usually imprinted with a legend similar to “Calibration Void If Broken or Removed” or “Calibration Seal—Do Not Break or Remove

” A calibration seal provides a means of deterring the user from tampering with any adjustment point that can affect the calibration of an instrument or detecting an attempt to access controls that can affect the calibration of an instrument

Note: A calibration seal may also be referred to as a tamper seal

calibration standard—An IM&TE item,

or measurement transfer standard which is designated as being used only to perform calibrations of other IM&TE items

As calibration standards are used to calibrate other IM&TE items,

they are more closely controlled and characterized than the workload items they are used for

Calibration standards generally have lower uncertainty and better resolution than general-purpose items


designation as a calibration standard is based on the use of the specific instrument,

not on any other consideration

For example,

in a group of identical instruments one might be designated as a calibration standard while the others are all general purpose IM&TE items

Calibration standards are often called mea-


) See also: standard (measurement) combined standard uncertainty—The standard uncertainty of the result of a measurement when that result is obtained from the values of a number of other quantities

It is equal to the positive square root of a sum of terms

The terms are the variances or covariances of these other quantities,

weighted according to how the measurement result varies with changes in those quantities

the demonstrated ability to perform the tests or calibrations within the accreditation scope,

and to meet other criteria established by the accreditation body

For a person,

the demonstrated ability to apply knowledge and skills

Note: The word qualification is sometimes used for this sense,

because it is a synonym and has more accepted usage in the United States

confidence interval—A range of values that is expected to contain the true value of the parameter being evaluated with a specified level of confidence

The confidence interval is calculated from sample statistics

Confidence intervals can be calculated for points,

For an infinite (or very large compared to the sample) population,

the confidence interval is CI = x  t

where CI is the confidence interval,

n is the number of items in the sample,

p is the proportion of items of a given type in the population,

s is the sample standard deviation,

and t is the Student’s T value for ␣⁄ 2 and (n  1) (␣ is the level of significance)

correction (of error)—The value that is added to the raw result of a measurement to compensate for known or estimated systematic error or bias

The correction value is equal to the negative of the bias

An example is the value calculated to compensate for the calibration difference of a reference thermometer,

or for the calibrated offset voltage of a thermocouple reference junction

See also: bias,

systematic error corrective action—Something done to correct a nonconformance when it arises,

including actions taken to prevent reoccurrence of the nonconformance

Compare with: preventive action

coverage factor—A numerical factor used as a multiplier of the combined standard uncertainty in order to obtain an expanded uncertainty

It is usually given the value 2,

which approximately corresponds to a probability of 95%

deficiency—Nonfulfillment of conditions and/or criteria for accreditation,

sometimes referred to as a nonconformance

departure value—A term used by a few calibration laboratories to refer to bias or systematic error

The exact meaning can usually be determined from examination of the calibration certificate

equivalence—Acceptance of the competence of other national metrology institutes (NMI),

and/or accredited organizations in other countries as being essentially equal to the NMI,

and/or accredited organizations within the host country

A formal,

documented determination that that a specific instrument or type of instrument is suitable for use in place of the one originally listed,

error (of measurement)—In metrology,

an estimate of the difference between the measured value and the probable true value of the object of the measurement

The error can never be known exactly

Error may be systematic and/or random

Systematic error (also known as bias) may be corrected

systematic error gage R&R—Gage repeatability and reproducibility study,

which (typically) employs numerous instruments,

and measurements over a period of time to capture quantitative observations

The data captured is analyzed statistically to obtain nest measurement capability,

which is expressed as an uncertainty with a coverage factor of k2 to approximate 95%

The number of instruments,

and length of time are established to be statistically valid consistent with the size and level of activity of the organization

GUM—An acronym commonly used to identify the ISO Guide to the Expression of Uncertainty in Measurement

In the United States,

the equivalent document is ANSI/NCSL Z540-2-1997,

Guide to the Expression of Uncertainty in Measurement

HIPOT (test)—An acronym for high potential (voltage)

A HIPOT test is a deliberate application of extreme high voltage,

to test the insulation system of an electrical product well beyond its normal limits

An accepted guideline for the applied value is double the highest operating voltage plus one kilovolt

Current through the insulation is measured while the voltage is applied

If the current exceeds a specified value a failure is indicated

HIPOT testing is normally done during research and development,

factory production and inspection,

A synonym is dielectric withstand testing

A high potential tester normally has meters to display the applied voltage and the leakage current at the same time


! HIPOT testing involves lethal voltages


! HIPOT testing is a potentially destructive test

If the insulation system being


the leakage creates a path of permanently lowered resistance

This may damage the equipment and may make it unsafe to use

Routine use of HIPOT testing must be carefully evaluated

Note: Hypot® is a registered trademark of Associated Research Corp

and should not be used as a generic term

IM&TE—Acronym refers to inspection,

This term includes all items that fall under a calibration or measurement management program

IM&TE items are typically used in applications where the measurement results are used to determine conformance to technical or quality requirements before,

Some organizations do not include instruments used solely to check for the presence or absence of a condition (such as voltage,

and so on) where a tolerance is not specified and the indication is not critical to safety

Note: Organizations may refer to IM&TE items as MTE (measuring and testing equipment),

TMDE (test,

GPETE (general-purpose electronic test equipment),

PME (precision measuring equipment),

PMET (precision measuring equipment and tooling),

or SPETE (special purpose electronic test equipment)

insulation resistance (test)—A test that provides a qualitative measure of the performance of an insulation system

Resistance is measured in Megohms

The applied voltage can be as low as 10 Volts DC,

but 500 or 1000 Volts are more common

Insulation resistance can be a predictor of potential failure,

especially when measured regularly and plotted over time on a trend chart

The instrument used for this test may be called an insulation resistance tester or a megohmmeter

An insulation tester displays the insulation resistance in Megohms,

and may display the applied voltage

Note: Megger® is a registered trademark of AVO International and should not be used as a generic term

interlaboratory comparison—Organization,

and evaluation of tests or calibrations on the same or similar items or materials by two or more laboratories in accordance with predetermined conditions

internal audit—A systematic and documented process for obtaining audit evidence and evaluating it objectively to verify that a laboratory’s operations comply with the requirements of its quality system

An internal audit is done by or on behalf of the laboratory itself,

International Organization for Standardization (ISO)—An international nongovernmental organization chartered by the United Nations in 1947,


The mission of ISO is “to promote the development of standardization and related activities in the world with a view to facilitating the international exchange of goods and services,

and to developing cooperation in the spheres of