Quality Calibration Handbook - Developing and Managing a Calibration Program

193 Pages·2007·3.554 MB·English

by  Bucher, Jay L.

The Quality Calibration Handbook
Developing and Managing a Calibration Program
Jay L. Bucher
ASQ Quality Press
Milwaukee, Wisconsin
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 5 4 3 2 1
Library of Congress Cataloging-in-Publication Data
Bucher, Jay L., 1949–
The quality calibration handbook : developing and managing a calibration program / Jay L.
Bucher. – 1st ed.
p. cm.
Includes bibliographical references and index.
ISBN 0-87389-704-8 (casebound : alk. paper)
1. Mensuration—Handbooks, manuals, etc. 2. Calibration—Handbooks, manuals, etc.
3. Quality assurance—Handbooks, manuals, etc. I. Title.
T50.B75 2006
658.4'013-dc22 2006027515
ISBN–10: 0–87389–704–8
ISBN–13: 978–0–87389–704–4
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Preface
M
an initially invented the wheel long before records were officially kept or writ-
ten down. Yet it is very possible that variations on the wheel were reinvented,
modified, changed, and improved upon many times, in many parts of the world,
over many generations. 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 par-
ticular 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 perform-
ing 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? Hopefully not, because there are many factors
that go into putting together a calibration system, most depending on what standards or
regulations govern the calibration function. However, is there one tried-
and-true quality calibration system that every organization can use as a foundation for its
personalized program? Yes, there is. That is where The Quality Calibration Handbook
comes in.
By using the quality calibration system outlined and demonstrated here, any organiza-
tion 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 calibra-
tion. But we’re getting ahead of ourselves. First, we have to define what calibration is and
what it is not.
In 1998, during an initial audit for ISO 9001, a trained, experienced auditor was in-
specting 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 oth-
ers in attendance all took a deep breath and held it. They thought there was never a time
ix
x Preface
that one corrected an auditor. Under most circumstances, that might be true. But I could
not allow her to be totally incorrect in how she did her job in this circumstance. I ex-
plained 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, all’s well that ends well. There were no findings, observations, or write-ups.
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, in April 2006, during a meeting with the regional sales representa-
tive 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. So, without further ado, here it is.
The following primary and secondary definitions are according to VIM 6.11 [an
acronym commonly used to identify the ISO International Vocabulary of Basic and
General Terms in Metrology (VIM),also known by the French title, Vocabulaire interna-
tional des termes foundamentaux et généraux de métrologie (VIM)] and NCSL
International (pp. 4–5):1
Calibration is 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, measurement standards, or artifacts as needed to verify the performance.
Calibration provides assurance that the instrument is capable of making measure-
ments to its performance specification when it is correctly used.
The result of a calibration is a determination of the performance quality of the in-
strument 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 determina-
tion of one or more corrections.
The calibration process consists of comparing test equipment with specified toler-
ances but of unverified accuracy, to a measurement system or device of specified
capability and known uncertainty, in order to detect, report, or minimize by adjust-
ment 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 measure-
ment conditions, and with a specified and controlled measurement system.
Preface xi
Many manufacturers [auditors, QA inspectors, and so on] INCORRECTLYuse the term
calibrationto 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 inde-
terminate state. Many calibration procedures in manufacturers’manuals are actu-
ally 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,orafter it is repaired.When used this way, calibration
means the same as alignment or adjustment, which are repair activities and ex-
cluded 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.
Calibrationis 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, repair, alignment, zeroing, or stan-
dardizing. All of these can be incorporated into the process at some point, depending on
what the item is, how it is used, and in some cases, 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, it’s because I am. I am excited about cali-
bration 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 fam-
ily 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. So, I have to tem-
per 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, the title is
boring. 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.
xii Preface
• 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 be-
fore, 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), production, and quality assurance arenas through ac-
curate, reliable, and traceable calibrations of their test equipment. If quality calibration
were not important, then it would not be a requirement in industry, government, and the
private sector.
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, vehicular crashes, and poisonings. How is this possible? By my ensur-
ing 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 exoner-
ated. Calibrated test equipment used in support of the airline and automotive industries
helps prevent disasters. While calibration technicians do their seemingly boring, mun-
dane jobs at the nation’s pharmaceutical companies, they are quietly laying the founda-
tion 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, success and failure, and—most important to shareholders and boards of
directors—profit and loss.
NOTE
1. Jay L. Bucher, The Metrology Handbook(Milwaukee: ASQ Quality Press, 2004), 472.
Contents
List of Figures and Tables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vii
Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ix
Acknowledgments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiii
Part I Why Calibration Is Critical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Chapter 1 Preventing the Next Great Train Wreck . . . . . . . . . . . . . 3
Chapter 2 Requirements and Standards—What They Really Say . . 9
Part II The Basics of a Quality Calibration System . . . . . . . . . . . . . . . . . . 23
Chapter 3 The Basics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Chapter 4 Calibration Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Chapter 5 Calibration Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Chapter 6 It’s Out of Tolerance—Now What? . . . . . . . . . . . . . . . . 49
Chapter 7 Calibration Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Chapter 8 Traceability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
NIST Policy on Traceability . . . . . . . . . . . . . . . . . . . . 81
Chapter 9 Uncertainty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
Measurement System Analysis—MSA . . . . . . . . . . . . 86
Uncertainty Calculator . . . . . . . . . . . . . . . . . . . . . . . . 92
System File . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
What Does the Crystal Ball Show for the Future? . . . 96
Chapter 10 Calibration Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
Part III Developing a Quality Calibration Program . . . . . . . . . . . . . . . . . . . 105
Chapter 11 Meeting Your Needs and Requirements . . . . . . . . . . . . . 107
Chapter 12 Calibration Environment . . . . . . . . . . . . . . . . . . . . . . . . 113
Chapter 13 Calibration Scheduling . . . . . . . . . . . . . . . . . . . . . . . . . . 117
Chapter 14 Calibration Software . . . . . . . . . . . . . . . . . . . . . . . . . . . 121
Chapter 15 Calibration Intervals . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125
Part IV Managing a Quality Calibration Program . . . . . . . . . . . . . . . . . . . . 131
Chapter 16 Continuous Process Improvement . . . . . . . . . . . . . . . . . 133
Chapter 17 Ethics . . . The Last Frontier . . . . . . . . . . . . . . . . . . . . . 139
Chapter 18 Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143
v
vi Contents
Chapter 19 The Audit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153
Chapter 20 Keeping Your Program Ahead of an Ever-
Changing World . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161
Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 183
About the Author . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 189
Part I
Why Calibration Is Critical
1
Preventing the Next
Great Train Wreck
O
n January 21, 2005, during the annual Measurement Science Conference (MSC),
held at the Disneyland Convention Center in Anaheim, California, the
Measurement Quality Division (MQD) sponsored a seminar on metrology edu-
cation. During that seminar, one of the audience participants was Dr. Klaus-Dieter
Sommer of Germany.
Dr. 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
someonesays,“Calibrationwastheproblem.”Wehaven’thadthetrainwreckwherethere
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
hadmanyinstancesoftragedyandlossoflifeovertheyears.Thenuclearindustryhashad
its fair share of problems, too.
Without calibration, or by using incorrect calibrations, all of us pay more at the gas
station, for food weighed incorrectly at the checkout counter, and for speeding tickets.
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; which weight is correct?
Errors in calibration can effect the automotive, nuclear, or space industries. They can
also have an impact on how long or wide a 2 (cid:1)4 is, not to mention the thickness of dry-
wall, how much radiation is emitted by a microwave oven, how much money you are
3