The Standard 11 Sep07

Vol. 21, No.
3 The Newsletter of the Measurement Quality Division, American Society for Quality September 2007
2007 NCSL International Workshop & Symposium

St. Paul River Centre, St. Paul, Minnesota
July 29 ~ August 2, 2007
Below: Dilip Shah, Chris Grachanen, Jay Bucher, Woody Niemann, & Graeme Payne
The Standard TABLE OF CONTENTS
Vol 21, No. 3, September 2007 MQD Officers for 2007 ~ 2008 ......................................................3
Chair’s Column...............................................................................4
Managing Editor and Publisher
Jay L. Bucher
Chair-Elect’s Column .....................................................................5
6700 Royal View Dr. Important CCT Program Update Information.................................6
De Forest, WI 53532-2775 MQD Meeting Minutes...................................................................7
Voice: 608-846-6968 The Learning Curve ........................................................................9
Email: yokota-69@charter.net APLAC Turns 15 Years Old.........................................................12
ILAC Celebrates 30 Years ............................................................13
Advertising AB Liaison Report ........................................................................14
Submit your draft copy to Jay Bucher, with a NCSL International Workshop & Symposium Report .................16
request for a quotation. Indicate size desired. Check Standards Can Save You Time ..........................................18
Since The Standard is published ‘in-house’ MQD Officers and Committee Chairs ..........................................21
the requester must submit a photo or graphic MQD Regional Councilors …………………………………… ..22
of their logo, if applicable. The following
rates apply:
A Quality Calibration System.......................................................24
Business card size ............................ $100
1/8 page .......................................... $150
1/4 page ........................................... $200
1/3 page ........................................... $250
FROM THE DESK OF THE EDITOR/PUBLISHER
½ page ............................................. $300 It’s hard to believe we have gone through another
Full page ......................................... $550 fiscal year at the MQD. We had a very successful
Advertisements will be accepted on a ‘per showing at this year’s NCSL International Work-
issue’ basis only; no long-term contracts will shop and Symposium in St. Paul, Minnesota (a
be available at present. Advertising must be photo of the venue is on the cover). Lots of traffic
clearly distinguished as an ad. Ads must be
at our booth, as well as many questions about the
related to measurement quality, quality of
measurement, or a related quality field. Ads MQD, the CCT (certified calibration technician)
must not imply endorsement by the Measure- program, and the CCT challenge coin. By the way,
ment Quality Division or ASQ. the coins for our new CCTs that were certified in December 2006 and June
2007 were mailed the last week of July. Everyone should have them by
Letters to the Editor now. If you have your CCT but have not received a CCT challenge coin,
The Standard welcomes letters from mem- please send me an email and we will see what we can do to rectify the
bers and subscribers. Letters should clearly situation. If you look closely on the cover, to the left of the ASQ logo are
state whether the author is expressing opin- two small ovals. They are the front and back of the CCT challenge coin for
ion or presenting facts with supporting infor- booth visitors to envy. We are still actively soliciting articles for future edi-
mation. Commendation, encouragement, tions of The Standard. They could be original, from past conferences or
constructive critique, suggestions, and alter- previously published (we need the appropriate permissions, of course) in
native approaches are accepted. If the con- other magazines or newsletters.
tent is more than 200 words, we may delete
portions to hold that limit. We reserve the
right to edit letters and papers. The Standard is published quarterly by the Measurement Quality Division of
ASQ; deadlines are February 15, May 15, August 15 and November 15. Text infor-
Information for Authors mation intended for publication can be sent via electronic mail as an attachment in
The Standard publishes papers on the qual- MS Word format (Times New Roman, 11 pt). Use single spacing between sen-
ity of measurements and the measurement of tences. Graphics/illustrations must be sent as a separate attachment, in jpg format.
quality at all levels ranging from relatively Photographs of MQD activities are always welcome. Publication of articles, prod-
simple tutorial material to state-of-the-art. uct releases, advertisements or technical information does not imply endorsement
Papers published in The Standard are not by MQD or ASQ. While The Standard makes every effort to ensure the accuracy
referred in the usual sense, except to ascer- of articles, the publication disclaims responsibility for statements of fact or opinion
tain that facts are correctly stated and to as-
sure that opinion and fact are clearly distin- made by the authors or other contributors. Material from The Standard may not be
guished one from another. The Editor re- reproduced without permission of ASQ. Copyrights in the United States and all
serves the right to edit any paper. Please sin- other countries are reserved. Website information: MQD’s homepage can be found
gle space after sentences and use Times New at http://www.asq.org/measure. © 2007 ASQ, MQD. All rights reserved.
Roman, 12 pt font.
MQD Page 3
THE MEASUREMENT QUALITY DIVISION (MQD)

OFFICERS FOR 2007 ~ 2008
Chair
Dilip A. Shah
E = mc3 Solutions
197 Great Oaks Trail #130
Wadsworth, Ohio 44281-8215
Voice (330) 328-4400 / Fax
(330) 336-3974
E-mail: emc3solu@aol.com,
dashah@aol.com
Chair-elect
Craig (Woody) Niemann
1489 Pheasant Run Dr.
Newark, OH 43055-8046
Voice (740) 788-5034
E-mail:
Craig.Niemann@afmetcal.af.mil
Secretary
Christopher L. Grachanen
Manager, Houston Metrology
Group HP
P. O. Box 692000 MS070110
Houston, TX 77269-2000
Voice (281) 518-8486 / Fax
(281) 518-7275
E-mail:
Chris.Grachanen@hp.com
Treasurer
Jay L. Bucher
Bucherview Metrology Services
6700 Royal View Dr.
De Forest, WI 53532-2775
Voice (608) 277-2522 / Fax
(608) 846-4269
E-mail: yokota-69@charter.net
Vol. 21, No. 3 The Newsletter of the Measurement Quality Division, American Society for Quality September 2007
MQD Page 4
CHAIR’S CORNER participation will come in many forms such as sur-

vey input, BOK review, item writing, item review,
By Dilip Shah exam review etc.. Please let us know how you can
Welcome to the Fall help.
2007 MQD newslet-
ter. I was asked to fill One of the many challenges we face today is to
in as Interim Chair of figure out who is going to replace our aging work-
the Division and I force. This problem is common in almost all pro-
have accepted the fessions. It is a global problem, but even more so in
responsibility. Due to a developed country like ours. We have partici-
increasing work com- pated in the Education & Training efforts of the
mitments, R i c k NCSLI in this activity. Within the E & T, there are
Roberson thought it many sub committees that we contribute to. We
best for the division would love to hear from you and how you are help-
to step down as ing to solve this issue in your area of work.
Chair. I want to thank
Rick Roberson for his This is your division. Please let us know how we
past contribution to the division and wish him the are doing, what kind of projects and initiatives you
best for the future. I am no stranger to the Chair would like the division to get involved in, and
role of the MQD as I fulfilled that role for the more importantly, how you can contribute. As a
2003-2005 terms. In between, I was active as the volunteer organization, its success depends on the
Program Chair and I will fulfill that role as well in contribution by its volunteers. I would like to thank
my current capacity. all our current volunteers for their steadfast sup-
port. But, we must have new ideas that can only
The Division continues to grow in many different come from fresh voices. We are always looking for
ways. It is strong and we have a good name recog- dedicated volunteers, contributors of articles to The
nition with other professional societies with which Standard and our sponsored column “Measure for
we partner in many activities. It is a good thing to Measure” in the ASQ’s flagship magazine, The
partner with other professional organizations where Quality Progress. Personally, I feel that volunteer-
we have common goals. ing gives me the satisfaction of doing the things I
want to do away from the pressures of normal
Our participation in the NCSLI conference in Au- work. The satisfaction of working with like minded
gust was superb. It was good to see 7 out of 8 au- individuals, exchanging ideas, learning to be a bet-
thors of The Metrology Handbook at the confer- ter manager has great benefits on my personal and
ence. That means that one lucky conference raffle professional life.
winner got a copy of The Metrology Handbook
with the 7 autographs. Out MQD booth got a lot I am excited for the coming year and am looking
enquiries about the CCT exam. forward to serving the division.
At the Measurement Science Conference in Ana- Sincerely,

heim in March 2008, we are going to sponsor a
CCT refresher workshop followed by the ASQ ad- Dilip
ministration of the CCT Exam. Look for more in-
formation on this in the future issue of The Stan-
dard.
As a division sponsor of the CCT Exam Body of

Knowledge (BOK), be aware that it will be re-
viewed and updated in 2008 and we will again be
looking for your participation in this effort. Your
MQD Page 5
CHAIR-ELECT’S COLUMN
By Craig A. Niemann, SMSgt, USAF
As the new Chair-Elect for the Measurement Quality Division, I feel it appropriate
for me to introduce myself. I’m Craig “Woody” Niemann and I began my career in
metrology in 1989 at Lowry Air Force Base, as many other people in the division
have done. Even though I went through 9 months of technical school training to be a
Precision Measurement Equipment Laboratory (PMEL) apprentice, I still don’t think
I had a true appreciation for the vast impact metrology has on every walk of life.
However, with the help of some outstanding trainers, one of which is the former chair
of the MQD I soon developed a deeper understanding and appreciation of the impor-
tance metrology plays in the world.
Here I am 18 years and a few assignments later and feel honored to serve as an Air Force Metrology
Laboratory Assessor. I function as part of a team that conducts assessments on all 77 USAF calibration
laboratories and the Air Force Primary Standards Laboratory, co-located with our team in Heath, Ohio.
The main question I get in my travels is “I thought the USAF did not have any more military PMEL’s”.
It’s true that there was an initiative being looked at to outsource the entire USAF metrology program in
the late 1990’s, but it was decided that this was not the best decision for the USAF and the effort was
halted. What remains is a workforce, that in my opinion combines the best of what every group has to
offer, active-duty, contractor and government civil service. I have performed evaluations on all the dif-
ferent types of laboratories and each workforce brings something different to the table and all are ex-
tremely professional and a pleasure to work with.
I sincerely look forward to working with everyone in MQD over the next few years. I have been ex-
tremely impressed with everyone I have met so far. I would especially like to thank Rick Roberson and
Jay Bucher for nominating me as Chair-Elect. Without their encouragement, I don’t think I would have
decided to volunteer for this position. If anyone has any feedback for me or additional questions about
the status of metrology in the USAF, feel free to contact me at the email address below.
SMSgt Woody Niemann

craig.niemann@afmetcal.af.mil
The latest CCT exam statistics

Date of Exam Sat for Exam Passed Exam % Passed
7-Jun-2003 97 69 71%
6-Dec-2003 107 69 64%
23-May-2004 4 4 100%
5-Jun-2004 133 102 77%
4-Dec-2004 139 104 75%
4-Jun-2005 152 116 76%
4-Dec-2005 159 88 55%
4-Jun-2006 122 88 72%
5-Aug-2006 1 1 100%
2-Dec-2006 99 64 65%
29-Apr-2007 1 1 100%
4-Jun-2007 143 105 73%
Totals 1157 811 70%
MQD Page 6
CCT PROGRAM UPDATE

The American Society for Quality (ASQ) Measurement Quality Division (MQD) is please to relate that
the Certified Calibration Technician (CCT) exam can be proctored on military bases having education
offices that are authorized to administer Dantes tests (ASQ’s other certification exams may also be proc-
tored) . The steps to apply for taking an exam are as follows:
1. Active military personnel, government employees and civilian contractors interested in taking the
CCT exam should first verify that their education office is authorized to administer Dantes tests.
2. (After verifying Step # 2) personnel should obtain the following contact information
· Name and location of the military base

· Name of person to proctor the exam
· Name of person requesting the exam
· Phone numbers for above
· Addresses for above
· E-mails (as applicable) for above
3. Contact information and exam application (see below) should be sent to Betty File
bfile@asq.org her phone number is 414-272-8575 ext 7748 (exam fee should also be sent at this
time).
ASQ will contact the person that will be proctoring the exam and provide instructions and the exam.
Information on ASQ’s CCT program can be found at:
http://www.asq.org/certification/calibration-technician/index.html
CCT exam application information may be found at:
http://www.asq.org/certification/calibration-technician/apply.html
Information on other ASQ certification programs can be found at:
http://www.asq.org/store/training-certification/
Note: If you are an active member of the U.S or Canadian military, you are eligible for a discounted
exam fee. You must submit a copy of your military ID when you apply. ID cards should be faxed to
414-298-2500. Your application will be placed on hold until a copy of your ID card is received.
MQD Page 7
ASQ MQD MEETING AT NCSLI CONFERENCE – JULY 2007

Attendees Present: Attendees Remote:
Christopher L. Grachanen Jay Bucher
Sara Garverick
Craig ‘Woody’ Niemann
Dilip Shah
Jay
x Deadline for article submittal for the next issue of The Standard is 15 Aug 2007.
x ASQ headquarters has a new Division Accountant, Bobbie Mulhall.
x Jay is working on his replacement for his MQD Treasury position which comes to term next year.
x Jay questioned who will be the MQD chair elect for 2008-2009. Discussions followed with no firm
candidate identified.
x MQD Financial Summary: As of July 31st, 2007, we had $77,614.52 in our Money Market account
and $58,347.49 in checking (All MQD and CCT coins have been paid for).
Jay to follow up with ASQ headquarters about the mailing of CCT coins … Update: Coins were mailed
out USPS on 27 July 2007 per Leta Thrasher, ASQ Administrator.
Dilip
x ASQ’s World Wide Conference abstract submittal deadline is 01 Aug 2007. Dilip and Graeme
Payne have submitted their abstracts.
x The MQD session track for the 2008 Measurement Science Conference (MSC) has been confirmed.
The 2008 MSC will be held on 10-14 March.
x A CCT Prep course will be offered at the 2008 MSC on Monday and Tuesday of the conference
with the CCT exam being given on Wednesday. Dilip will be teaching the CCT Prep course for free.
The offering of the CCT Prep course and CCT exam is a piloted program which if successful will be
offered at next year’s NCSLI national conference. ASQ’s CQT and CQI exams will also be offered at
MSC (no prep courses for CQT and CQI will be offered at the 2008 MSC).
x The 2007 MQD / Inspection Conference has been cancelled due to lack of presenters (conference
was tentatively scheduled for the end of Sept. 2007).
Nominated Norm Belecki for the 2007 Max J. Unis award. A vote was taken which unanimously passed.
Presentation of the award will be either at the 2008 MSC or the 2008 CPEM conference.
Chris
x Update on the CCT program (CCT alumni is now 811 strong).
x Chris confirmed ‘ear marking’ approx. $25k for updating the CCT Body of Knowledge (BOK).
ASQ requires all certification BOK’s to be updated every 5 years. The ‘ear marked’ funds will be used
to pay a contractor to construct an on-line survey, disseminate the survey to participants, compile survey
responses and summarize results.
x Jay accepted championing the CCT program per ASQ’s certification program secession planning
requirements.
Update on activities with the US Dept. of Labor and the Office of Personnel Management (OPM) re-
garding Metrology job descriptions.
(Continued on page 8)
MQD Page 8
(Continued from page 7)

ACTION ITEMS:
Jay
1. Need to complete and submit MSC co-sponsorship Letter of Memorandum; update—completed at
NCSLI on Tuesday, August 1st, given to Woody Niemann.
2. Richard Roberson and Woody need access to MQD’s Share Point; update—link, logins and pass-
words sent out August 4th.
Jay to coordinate Quality Progress’s Measure For Measure column (different authors will be responsible
for writing articles and submitting them in a timely manner); next three editions have author’s commit-
ted.
Dilip
1. Contact Carol Singer of Cal Lab Magazine to promote the CCT Prep course and CCT exam that will
be offered at MSC.
Research past recipients of MQD’s Max J. Unis award for posting to the MQD website
Chris
1. Develop an activity roadmap for updating the CCT BOK which is scheduled to begin in early 2008.
Provide a copy of the US Air Force letter which mentioned the CCT program as an US Air Force sanc-
tioned program for posting to MQD’s Share Point.
Woody
1. Research the possibility of offering the CCT exam on military bases (education offices).
Research how CCT exam fee is reimbursed by the US Air Force for personnel taking the exam.
Graeme
1. Send MQD historical documents and records to Jay.
Research getting a ‘mobile friendly’ MQD display booth.
GENERAL DISCUSSIONS
x Several MQD officers participated in NCSLI conference education sessions (Education Outreach
Panel and CCT Program Update) as well as attending several NCSLI Metrology education committee
meetings.
x Three copies of the Metrology Handbook were signed by authors present at the conference and
given to NCSLI personnel for door prizes.
Many inquires regarding MQD and the CCT program were answered for conference attendees visiting
the MQD booth (Chris, Dilip, Graeme, Jay and Woody covered booth duties). Traffic at the MQD booth
was good. Conference attendee comments regarding MQD and the CCT program were generally favor-
able.
Respectfully Submitted,
ASQ MQD Secretary
MQD Page 9
THE LEARNING CURVE had been introduced by the French Revolutionists

who otherwise spent most of their time chopping
By Phil Painchaud off the heads of the French nobility. Since most of
Europe was governed by other nobility, the Metric
This is the fifty-first iteration in
System was finding little favor among those other
an uninterrupted contiguous
nations of that continent—the stigma of the French
series of discantive dissertations
Revolutionist’s head chopping was attached.
charted to be on the general sub-
ject of Metrology Education.
Bugge and the rest of the members of the Confer-
We are now about to commence
ence, all scientists of note in their own right, did a
our sixteenth year of writing
Herculean task of straightening out the errors and
these open letters to our es-
discrepancies of the System as proposed and mak-
teemed Boss, the Managing
ing it acceptable and workable. It should be noted
Editor of this journal. We shall
that Bugge was not totally in favor of all aspects
attempt in this iteration to remain close to our
and was successful in having them deprecated.
charted subject which occasionally we cannot do
These factors were the attempts to decimalize time
to the necessity of updating our readers (if any) of
and angular measurements. As an astronomer he
breaking news items of metrological interest, or to
could see the impossible task of re-computing the
the lack of current viable inputs on the subject from
vast quantities of astronomical and navigational
our reader,
data that had been compiled up to that time.
Dear Boss:
(That is why world wide today we are still using
a sexagesimal system rather than a decimal sys-
Awhile back, in Column 48 to be precise, I offered
tem for time keeping, navigation, and angular
a prize of $100.00 to whomever among our readers
measurements. Even with our modern com-
could answer a question I had asked in Column 46:
puter capacities such a conversion task would be
“ WHO WAS THOMAS BUGGE AND WHAT
overwhelming.)
WAS HIS CONTRIBUTION TO METROL-
OGY?” I set a time limit that all answers had to be
But he did write glowingly of the advantages of the
in my hands by January 2, 2007, and I also speci-
Metric System in his widely read articles, thus sof-
fied that all answers must be in writing — US mail
tening the attitudes of the rulers and gentry of those
or FAX—no phone calls or e-mail. Well for six
various other European nations. France formally
months nobody answered me. Finally, during June
adopted the System in 1799 and, thanks to Bugge,
I received an e-mail from a Mr. Monrea (he didn’t
the rest of Europe followed in rapid succession.
identify himself beyond that—no company of job
title). His response was just to repeat the name of
Now let us get down to the business we are charted
the individual that I had already given and his re-
to do—discussing Metrology Education. Carol
sponse was by e-mail and nearly six months too
Singer, the Publisher/Editor of the CAL-LAB
late. So I guess that I shall have to give you the
magazine is an old and dear friend of long stand-
answer myself.
ing, we seldom disagree except on details. In her
current issue, she published an editorial entitled
Thomas Bugge was a Danish Astronomer during
“The Future of Metrology”. Her theme might
the later part of the 18th Century. His avocation was
have been taken from a statement that I copied di-
writing scientific articles slanted for popular con-
rectly from an NIST e-mail and presented to you in
sumption. His writings were translated into many
Column 49 — “We must somehow provided for
languages and were widely read by the intelligent-
the academic education of a new generation of
sia and gentry of Europe. You might say that he
Professional Metrologists!”. In her editorial she
was the “Isaac Asimov of his day”. In 1798 he was
bemoaned the fact that we are not training (or edu-
the Danish representative to the first international
conference on weights and measures, a body that (Continued on page 10)
was called to codify the new Metric System that
MQD Page 10
(Continued from page 9) tific research, and of educational institutions. These

cating) enough Metrologists or even enough tech- are the final customers of the products on any col-
nicians to fill today’s needs much less the needs of lege level educational program. It is with these cus-
the future. She lauded the attempt made by another tomers, the managements, where we must start de-
organization to help remedy the situation by build- veloping the demand for competent fully trained
ing a fund for scholarships “and to support their Metrologists. When the management of industry
efforts to reach into the schools and make them starts demanding degreed Metrologists, then and
aware of Metrology as a career”. only then will the management of the universities
be forced to respond, for there is their market and if
I dislike being placed in the position of “wet blan- they do not respond, they could be soon out of
ket” or ‘Devil’s Advocate’. But why grant those business themselves.
kids scholarships when there is no place for them
to go to study Metrology and little or no market for It seems that this all boils down to the fact that we
them should they somehow attain such training? must find a way to convince management of the
All the academic efforts we have been working on value of having a properly constituted Metrology
for the past two decades have withered except Herb organization headed by a fully qualified Metrolo-
O’Neal’s sub-academic vocational program at gist. How can we do this? I am really not sure. Any
Ridgewater. There is not much point in trying to suggestions? Remember that most of the people
convince the school administrations of the advis- who must be convinced are probably products of
ability of instituting Metrology programs unless business schools. If I dared to express my opinion
they can see a market for that kind of a product. of many of those institutions based upon caliber of
their product that I have encountered during my
As I have explained in earlier columns, a school, professional career, I might have a multitude of
any school from a kindergarten to a university, can slander and liable suits filed against me.
be compared business wise to a factory. A factory
processes raw material into products for which So I am wide open for suggestions; good practical
there is a market. The demands of that market de- (and most important workable) suggestions of how
termine the nature of the product produced. If there we, the practicing professional Metrologists, can
is no demand if the demand diminishes for a par- convince industrial management of the necessity of
ticular product, the factory management then has it installing proficient Metrology facilities and hiring
produce a different product. A school is no differ- only fully qualified adroit Metrologists to oversee
ent; it processes a raw product; the student. For the these Metrology functions. Please send your sug-
kindergarten and elementary school, the customer gestions directly to me, in writing and fully identi-
is the parent. The parental demands exercised fied in order that I may give you full credit in this
through pressure on local school boards and by column.
lobbing of state legislators can and do shape the
processing applied to the student during this devel- Shall we try for another Metrological history ques-
opmental phase. The high schools on the other tion—with a monetary prize for the first best an-
hand have two classes of customer; the colleges swer(s)? The prize will be the same $100 USD note
and universities on the one hand and the local labor that I offered in Column 48 and is yet unclaimed.
market on the other. For the former they must pro- Here are my questions, all inter-related:
duce a semi-processed product ready for more ad- x What was the full name of the individual who
vanced conditioning. For the latter, a finished prod- invented the first sealed glass thermometer?
uct is required to meet the demands of that local x In what year did this person invent the device?
labor market.
x Precisely where was this person when they in-
vented the device?
The colleges and universities must take partially
processed product of the high school and finish x Why was that person in that location at that
process it into something that fits the demands of time?
the managements of industry, of business, of scien- (Continued on page 11)
MQD Page 11
ȱyourȱcalibrationȱprogramȱȱȬȱȱ
Gaveȱyouȱconsistentlyȱaccurateȱresults?ȱ

MetȱISOȱstandardsȱorȱFDAȱrequirements?ȱ

HadȱaȱtraceabilityȱpaperȬtrail?ȱ

TrackedȱoutȬofȬtoleranceȱconditions?ȱ

Hadȱaȱpaperlessȱrecordȱsystem?ȱ

Wasȱproactiveȱinsteadȱofȱreactive?ȱ

Theȱsolution…ȱ
aȱQualityȱCalibrationȱSystemȱ
In-house calibration programs for biotech
and pharmaceutical companies, meeting all
ISO standards and QSR requirements.
Toȱfindȱoutȱmoreȱvisit:ȱ
www.BucherviewȬ
Metrology.comȱ
JayȱL.ȱBucher,ȱASQȱCCTȱ
(608)ȱ846Ȭ6968ȱ

Meanwhile, as I have said half a hundred times
Now don’t try to tell me that it was Daniel Fahren- before, “You can reach me at:
heit, René-Antoine Rèaumur, or Anders Celsius.
These worthy individuals all provided improve- PHIL PAINCHAUD
ments to and more practical scales for the device 1110 WEST DOROTHY DRIVE
invented by our gentleman of interest. Another BREA, CA 92821-2017
clue: I use the term “gentleman” knowingly as he PHONE: 1-714-529-6604
was a respected member of the nobility of his na- FAX: 1-714-529-1109
tion. e-MAIL: painchaud4@cs.com or
olepappy@juno.com
Let us go over the rules once again:
1. Your answers must be in my hands (not just

postmarked) no later than September 15, 2007.
2. Your answers must be in writing—U.S Mail or
by FAX. No phone calls or e-mail.
3. You must answer all four parts of the questions
correctly—no partial credits.
4. I am the sole judge of the correctness of all an-
swers and of the disposition of any prizes.
5. All respondents correct or not, will be credited in
this column.
MQD Page 12
SERVING INTERNATIONAL TRADE FOR 15 YEARS

In 2007, the Asia Pacific Laboratory Accreditation Cooperation Inc,
known usually as "APLAC", celebrates its 15th Anniversary. Since
its inception in 1992 and especially since the inaugural signing of
the APLAC Mutual Recognition Arrangement (MRA) in 1997,
APLAC has helped to serve international trade by reducing trade
barriers and facilitating recognition of test, measurement and in-
spection reports issued by accredited laboratories through the
APLAC MRA.
The culmination of APLAC’s celebration of its 15th Anniversary will be at its General Assembly and
associated meetings from 2- 7 December, in Kuala Lumpur, Malaysia.
APLAC’s membership consists of organizations in the Asia Pacific region responsible for accrediting
calibration, testing and inspection facilities, and reference material producers.
APLAC now boasts the successful establishment of a fully operational Mutual Recognition Arrange-
ment (MRA) linking 26 accreditation bodies in 17 economies across the Asia - Pacific region. The
economies are: Australia; Canada; Peoples Republic of China; Hong Kong, China; India; Indonesia; Ja-
pan; Republic of Korea; Malaysia; Mexico; New Zealand; The Philippines; Singapore; Chinese Taipei;
Thailand; United States of America; Vietnam.
In the US, four accreditation bodies are signatories to the APLAC MRA. These are Assured Calibration
Laboratory Accreditation Select Services (ACLASS) (for testing and calibration), American Association
for Laboratory Accreditation (A2LA) (for testing, calibration and inspection), International Accredita-
tion Service (IAS) (for testing, calibration and inspection) and the National Voluntary Laboratory Ac-
creditation Program (NVLAP) (for testing and calibration).
Mutual recognition means that each MRA signatory accepts the accreditations granted by the other sig-
natories as equivalent to its own. This facilitates endorsed test, measurement and inspection reports from
the exporting economy to be accepted in the importing economy, avoiding the need for re-testing, re-
calibration or re-inspection, thus saving time and money. Regulators worldwide increasingly use ac-
creditation (and the APLAC MRA network) as evidence of competence to carry out testing, measure-
ment and inspection for mandatory purposes. APLAC is recognized by Asia Pacific Economic Coopera-
tion (APEC) member economies as a Specialist Regional Body (SRB).
APLAC's principal objectives are to foster the development of competent laboratories inspection bodies
and reference material producers in member economies, to harmonize accreditation practices in the re-
gion and with other regions, and to facilitate mutual recognition of test, measurement and inspection
reports through the APLAC Mutual Recognition Arrangement.
To learn more about APLAC, please visit www.aplac.org.
Submitted by: Hershal C. Brewer, CCT

Accreditation Officer
International Accreditation Service
Phone: 562-699-0541 Ext 3222
Mobile: 951-326-5216
hbrewer@iasonline.org http://www.iasonline.org
MQD Page 13
MEDIA RELEASE
ILAC Celebrates 30 Years
(International Laboratory Accreditation Cooperation 1977-2007)
ILAC is the international cooperation of laboratory and inspection accreditation bodies which this year
celebrates its 30th anniversary. One of the primary aims of ILAC is the removal of technical barriers to
trade.
Imagine you are importing toys from another country. The toys have been tested in that country by a
laboratory which says it meets international safety standards. But how do you convince your authorities
that the tests –and results – are genuine?
That dilemma was a major impediment to international trade 30 years ago, but today, thanks to a handful
of pioneers, things have changed for the better.
The ability of authorities to trust technical standards and procedures from different countries reaches an
important milestone this year - with the International Laboratory Accreditation Cooperation (ILAC)
celebrating 30 years of helping the world's economies overcome technical barriers to trade.
ILAC’s evolution was prompted by the Tokyo round of international trade negotiations under the Gen-
eral Agreement on Tariffs and Trade (GATT). The outcome was the GATT Standards Code, an agree-
ment between a number of the member states encouraging recognition of the equivalence of different
standards, and the variety of testing and accreditation regimes.
ILAC’s Chair, Daniel Pierre said: “The first conference on International Laboratory Accreditation, was
convened in Copenhagen in 1977 by Mr Per Lund Thoft of the Ministry of Trade, Denmark with the
support of Dr Howard Forman of the US Department of Commerce. Twenty countries from around the
world, the EEC Commission and ISO accepted their invitation.”
The conference gave countries that already had, or were planning accreditation schemes an opportunity
to compare notes and experiences. The delegations with practical experience were The National Testing
Board of Denmark (1977), NVLAP US Department of Commerce (1976), BSI's System of the Registra-
tion of Test House, UK (1977) NATA - Australia (1947) and TELARC - New Zealand (1973).
“The outcome of that first ILAC conference was the idea that mutual recognition agreements between
accreditation bodies meant any laboratory, anywhere could have their test results recognised as reliable.
ILAC from its inception has worked to create an international framework to support international trade
through the removal of technical barriers. This is now recognised through the ILAC Mutual Recognition
Arrangement (MRA). Fifty eight signatories, representing 46 economies have now signed the ILAC Mu-
tual Recognition Arrangement, enhancing the acceptance of products and services across national bor-
ders,” Mr Pierre said.
Further information about ILAC is available from the website at:

http://www.ilac.org/aboutilac.html.
To download historic ILAC photos go to: http://www.ilac.org/Photos
Submitted by:
Phil Smith American Association for Laboratory Accreditation (A2LA)
Phone: 301 644 3204 Email: smedellin@A2LA.org Web: www.A2LA.org
MQD Page 14
AB Liaison Report products in Oregon.
IAS: IAS Vice President Patrick McCullen participated

IAS participated in the development of the person- in a joint evaluation of the National Association of
nel certification development for certification of Testing Authorities, Australia (NATA) for the Asia
Assessors for ISO/IEC 17025. The Scheme has Pacific Laboratory Accreditation Cooperation
been developed by RABQSA in liaison with the (APLAC) and the European Cooperation for Ac-
Mexican accreditation body Entitad Mexicana de creditation (EA). The evaluation comprised an in-
Acreditacion (EMA), the Canadian Association of ternational team of evaluators from Canada, Tai-
Environmental Analytical Laboratories (CAEAL), wan, India, Finland, Japan and the United States.
the Institute for National Measurement Standards
National Research Council of Canada and the IAS Accreditation Officer Hershal C. Brewer,
American-based International Accreditation Ser- CCT, contributed to an article Certified “Safe”?
vice (IAS). published in the June 2007 issue of Quality Digest.
Brewer is quoted in the article, and provided a sig-
The National Cooperation for Laboratory Accredi- nificant amount of supporting information to the
tation (NACLA) honored IAS Vice President Pat- article’s author during the interview; including in-
rick McCullen with a special service award for a formation that may be useful for consumers seek-
decade of service working toward establishing a ing safe products, information for manufacturers
national laboratory accreditation system. NACLA, that are seeking laboratories to have products tested
a not-for-profit corporation established in 1998 by for safety, information on some of the many types
public and private-sector organization representa- of testing conducted, and sources for additional
tives, provides coordination and focus for labora- information.
tory accreditation programs in the United States.
IAS, one of the founding members of NACLA, For additional information regarding IAS or IAS
continues to maintain NACLA recognition. As a programs, please visit http://www.iasonline.org or
past member of the NACLA Board of Directors, e-mail hbrewer@iasonline.org
McCullen was instrumental in defining the organi-
zation’s mission to accredit U.S. laboratory ac- ACLASS:
creditation bodies. ACLASS is holding is annual assessor/expert fo-
rum September 21 – 23, 2007 at the Cincinnati
IAS hosted Roslan Alias, Assistant Director, Ac- Sheraton North Hotel. The forum covers topics
creditation Division, Department of Standards Ma- such as measurement uncertainty, assessing to ISO/
laysia (DSM), Ministry of Science, Technology IEC 17025, and proficiency testing. This year’s
and Innovation, Government of Malaysia on at- forum will also entail several presentations includ-
tachment training. During his visit, Roslan studied ing a presentation with discussion regarding a cus-
the U.S. inspection agency accreditation process, tomer’s perspective on accreditation.
and received training on the infrastructure require-
ments needed to operate an accreditation program Immediately following the forum, September 24 –
under ISO/IEC Standard 17020 requirements. IAS 26, 2007, ACLASS is holding a practical measure-
Director of Accreditations Raj Nathan defined the ment uncertainty training class, which includes
many processes and policies governing the IAS hands-on breakouts for physical/dimensional, elec-
inspection body accreditation program, and walked trical and testing uncertainties. Participants choose
Alias through the IAS system. Alias also accompa- from one of the three areas requiring measurement
nied IAS Accreditation Officer Sandi McCracken uncertainty. To register for the class, visit
and Dave Palfini of Testing Engineers, Inc., to ob- www.aclasscorp.com or email
serve the steel fabrication inspection process in info@aclasscorp.com.
Utah. Alias also accompanied IAS Accreditation
Officer Hershal Brewer and an inspector from SGS (Continued on page 15)
US Testing Co., to an inspection of wood-based
MQD Page 15
(Continued from page 14) NVLAP:

A2LA: NVLAP Launches e-Newsletter
Revision of the A2LA Newsletter
NVLAP recently launched its redesigned newslet-
In June 2007, the A2LA newsletter was issued in ter - NVLAP News - in an electronic format. The
its newly revised format. A2LA Today is scheduled newsletter is distributed to NVLAP laboratories
for publication once a quarter, which is typically and assessors via e-mail, and is available on this
March, June, September and December. Through web site at: http://www.nist.gov/nvlap. One of
this publication, A2LA will communicate upcom- NVLAP's objectives for quality is to communicate
ing activities, updates to various policies and re- frequently with customers and stakeholders to de-
quirements, as well as the outcome of any meetings termine their accreditation needs and requirements.
attended by A2LA. The next edition is scheduled The new e-Newsletter is one means for fulfilling
for release in September 2007. this objective. We are anxious to hear how you like
the newsletter and whether it meets your informa-
Some articles that may be of interest in the June tional needs!
issue are: Activities of the ILAC Arrangement Com-
mittee regarding recent activities with the Interna- Submitted by:
tional Laboratory Accreditation Cooperation and
Are All National Measurement Standards Equiva- Hershal C. Brewer, CCT
lent? written by Dr. Pedro Espina from the Bureau Accreditation Officer
International des Poids et Mesures (BIPM). The International Accreditation Service
latter article outlines the concept of traceability 5360 Workman Mill Road
from the SI to the National Metrology Institute to Whittier, CA 90601
Accredited Laboratories. The information detailed Phone: 562-699-0541 Ext 3222
in this article outlines the basis for the A2LA Fax: 562-699-8031
Traceability Policy. Mobile: 951-326-5216
hbrewer@iasonline.org
A2LA Launches Information Technology Ac- http://www.iasonline.org
creditation Program
A2LA has developed a new Information Technol-

ogy (IT) field of testing within our accreditation
programs. Addition of this new field of testing pro-
vides the IT industry with a new and viable way to
determine the technical competence of laboratories
that test any aspect of the hardware and/or software
within electronic equipment, not just the encryption
functions. This type of testing can be physical,
logical, virtual, or analytical. Laboratories accred-
ited in this program are required to meet the re-
quirements of ISO/IEC 17025:2005 as well as ad-
ditional requirements documented in the A2LA
Specific Criteria for the Accreditation of Various
Types of Information Technology Testing Labora-
tories.
For additional information regarding this program,

please contact Steve Medellin at 301 644 3228 or
smedellin@a2la.org.
MQD Page 16
NCSLI 2007 Report

Compiled by Dilip A. Shah – MQD Program Chair
This year’s NCSL International conference was held at the Riverfront Convention Center in St. Paul,
MN during July 29 – August 2, 2007.
The overall attendance was about 1,100 attendees and 565 tutorial attendees which is a record for the
conference tutorials.
The Measurement Quality Division had a booth display at the conference which was manned by the
usual team of Graeme Payne (Immediate MQD Past Chair) and Dilip Shah (MQD Past Chair). However,
this year, we also had Jay Bucher (MQD Treasurer), Chris Grachanen (MQD Secretary) and Craig
(Woody) Niemann (MQD Chair-Elect) attending and they also contributed to booth duties. Interest in
the ASQ CCT examination continues to be strong and draws a lot of traffic to the booth. This year was
no exception.
L-R: Dilip Shah, Chris Grachanen, Jay Bucher, Craig (Woody) Niemann, Graeme Payne
All of the MQD team members mentioned were involved in various NCSLI activities either as present-
ers and/or Committee/Panel Members.
MQD Page 17

Jay Bucher presented a paper on “A Quality Calibration System”. Jay also hosted Session 8A – “US
University Offerings in Metrology”. Graeme Payne was a panel member on “Traceability I and II” pan-
els. The MQD was also involved in the NCSLI Education and Training session track and Dilip Shah pre-
sented a paper on “CCT Examination Body of Knowledge Update”. The CCT BOK will be 5 years old
and is due for a review and update. The presentation also made note of this effort and solicited volun-
teers. Dilip Shah was also a panel member and co-presenter on the “NCSLI Next Generation Outreach”.
Chris Grachanen was participating in the NCSLI Sub committee 163.1 – Working Group on Standard
Occupational Classifications where he was awarded the Certificate of Appreciation by the US Army
TMDE, presented by Don Ruth of US Army. On Sunday before the conference Dilip Shah volunteered
by teaching the Workshop T15 – “Analysis of Quality Control Data for Laboratory Technicians and
Managers” as part of the NCSLI tutorial offerings.
Chris Grachanen receiving his Certificate of Appreciation

L-R: Graham Cameron, Chris Grachanen, Georgia Harris, Don Ruth
This year, 7 of the 8 co-authors of The Metrology Handbook were present at the conference. This made
it possible to autograph three (3) copies of The Metrology Handbook and donate them as door prizes at
the end of the conference.
MQD Page 18
Chris Grachanen’s Certificate of Appreciation
The MQD general meeting was conducted on Monday July 30, 2007 during the NCSLI. Teleconferenc-
ing was available for participants to join in this meeting. The minutes of the meeting are printed else-
where in this newsletter.
CHECK STANDARDS CAN SAVE YOU TIME

The benefits of employing check standards as a way of monitoring measure-

ment process variability has been well documented over the years. But did you
know that using check standards on a regular basis can save you time? A case
in point is the use of check standards and the calibration of vector network ana-
lyzers (VNA) prior to performing high frequency scattering parameter (s-
parameter) measurements.
First, let’s discuss the characteristic of a good check standard. As the name implies, a check standard is
used as a means to check (monitor) a process, usually within a manufacturing and / or measurement sce-
nario. Check standards are not standards in the traditional sense as normally associated with calibration
standards but rather are artifacts whose measurement attributes are defined and stable over time. Check
standards are selected based on their suitability for a particular process in order to determine perform-
ance aspects of the process i.e. if dimensional (length) accuracy is a critical aspect of a measurement
process, a check standard would normally be selected with a length similar to the length of the units be-
MQD Page 19

ing measured by the process. A check standard does not need to be accurate in terms of a nominal value
but rather be characterized for its actual value to a resolution which is useful to evaluate the process it
will be used in. It is the check standard’s stability over time regarding its measurement attribute(s) which
make it useful to monitor a process.
So how does measuring a check standard on a regular basis save time in regards to VNA calibration
prior to performing s-parameter measurement? The following scenario depicts a four port VNA used to
perform differential and common mode measurement but also is applicable for two port and other multi-
port VNAs. Before performing s-parameter measurements with a VNA it must first be calibrated to es-
tablish its inherent performance attributes in terms of directivity, port isolation, transmission loss, etc.
Calibration is normally performed using a calibration kit comprised of artifacts with known attributes. A
typical SOLT (Short – Open – Load – Thru) calibration kit will have short, open, thru and 50 ohm termi-
nation artifacts with both male and female connectors. The attributes of these calibration kit artifacts in
terms of propagation delay, phase, etc. is well established and can be uploaded to a VNA so that its in-
herent performance can be determined relative to these known attributes. Calibration of a VNA involves
physically connecting calibration kit artifacts on each port (Short, Open, Load) or connecting ports to-
gether (Thru) and making a measurement. A typical calibration scheme for a SOLT calibration kit is
depicted in Figure 1.
Fig. 1
Based on the frequency range and the number of points to be measured throughout that range measure-
ment time can be in the 10s of seconds for each port and thru connection. In addition each measurement
requires the calibration kit artifact be connected and properly torqued. It can easily be seen that calibrat-
ing a VNA using manual calibration artifacts can be a lengthy process. This is the opportunity where
using check standards can save time. Once a VNA has been calibrated, a check standard with suitable
attributes can be measured by the VNA and the results of the measurement archived for comparison pur-
poses. Evaluation of subsequent measurements of the check standard can be used to verify a VNA’s per-
formance attributes are sufficiently stable so that re-calibration may not be necessary. Figure 2 depicts
sequential transmission loss measurements of a check standard with the VNA calibration having been
performed prior to the first iteration (16 May).
MQD Page 20
Fig. 2
Notice that the seven measurement iterations over the course of nine days measured nearly identical val-
ues for the check standard’s transmission loss from 10MHz to 10GHz. So rather than performing a
lengthy calibration of a VNA using a manual calibration kit, a check standard may be quickly measured
to determine if the VNA’s calibration has drifted to the point where re-calibration is warranted. Of
course one must perform the evaluation based on the requirements of the measurement application the
VNA will be used in and the relative stability attribute(s) of the check standard. In addition to a real pos-
sibility of saving time by foregoing a VNA calibration it is an added benefit that comparison of sequen-
tial check standard measurements can provide that ‘warm fuzzy’ before making measurements with the
VNA.
It is acknowledged that automated calibration kits can substantially reduce VNA calibration time but are
currently not available for higher frequency ranges and are applicable to coaxial environments (Using a
VNA in a micro-probing environment typically involves using calibration substrates in order to calibrate
to the tips of the probes. The use of a check standard as described above is especially applicable in a mi-
cro-probing environment where VNA calibration times can be substantially more than for a coaxial en-
vironment). It must be duly noted that check standards are not a substitute for calibration standards when
calibration is necessary (traceablity of measurements is established by performing calibrations using
calibration standards which are traceable to higher order standards).
The use of check standards has the potential to save time in terms of the need to re-calibrate a VNA.
Proper evaluation of one’s measurement application and check standard measurement history is critical
when utilizing this time saving technique.
MQD Page 21
MEASUREMENT QUALITY DIVISION OFFICERS AND COMMITTEE CHAIRS

Chair, Nominating Chair, Program Chair Standards Committee Representative
Dilip A. Shah Robert M. Graham
E = mc3 Solutions Primary AC Standards Lab
197 Great Oaks Trail #130 Sandia National Laboratories
Wadsworth, Ohio 44281-8215 P.O. Box 5800, M.S. 0665
Voice (330) 328-4400 / Fax (330) 336-3974 Albuquerque, NM 87185-0665
E-mail: emc3solu@aol.com, dashah@aol.com Phone: (505) 845-0434
Fax: (505) 844-6096
Chair-Elect E-mail: rmgraha@sandia.gov
Craig (Woody) Niemann
1489 Pheasant Run Dr.
Newark, OH 43055-8046 Examining Chair
Voice (740) 788-5034 Duane Allen
E-mail: Craig.Niemann@afmetcal.af.mil U. S. Navy
P.O. Box 5000, Code MS11
Secretary, Certification Chair, Website Corona, CA 92878-5000
Manager, NCSL International Representative Voice (909) 273-4783 / Fax (909) 273-4599
Christopher L. Grachanen E-mail: duane.allen@navy.mil
Manager, Houston Metrology Group HP
P. O. Box 692000 MS070110
Houston, TX 77269-2000 Historian
Voice (281) 518-8486 / Fax (281) 518-7275 Keela Sniadach
E-mail: Chris.Grachanen@hp.com Promega Corp.
5445 East Cheryl Parkway
Treasurer, Publication Chair, Newsletter Madison, WI 53711
Editor/Publisher, Share Point Administrator Voice (608) 298-4681 / Fax (608) 277-2516
Jay L. Bucher E-mail: keela.sniadach@promega.com
Bucherview Metrology Services
6700 Royal View Dr.
De Forest, WI 53532-2775 ASQ Division Administrator
Voice (608) 277-2522 / Fax (608) 846-4269 Ms. Leta Thrasher
E-mail: yokota-69@charter.net or Voice (800) 248-1946, x7423
Jay.Bucher@Bucherview-Metrology.com E-mail: lthrasher@asq.org
Immediate Past Chair

Graeme C. Payne
GK Systems, Inc.
4440 Weston Drive SW, Suite B
Lilburn, GA 30047 USA
Voice: (770) 931-4004 / Fax (866) 887-9344
E-mail: Graeme@gksystems.biz
Joe Simmons Scholarship

Norm Belecki
7413 Mill Run Dr
Derwood, MD 20855-1156
Voice (301) 869-4520
E-mail: n.belecki@ieee.org
MQD Page 22
ASQ MEASUREMENT QUALITY DIVISION REGIONAL COUNCILORS
Regional Councilors represent the Division to members and Sections in their

geographic areas. Regional Councilors are appointed for renewable two-year
terms, and are advisory members of the Division leadership team.
Region 1 (CT, MA, ME, NH, RI, VT) Region 9 (IN, KY, OH)
Mr. Jun Bautista Mr. Ryan Fischer, ASQ CCT
Genzyme Laboratory Accreditation Bureau
Cambridge, MA 02142 New Haven, IN 46774
E-mail: Jun.Bautista@genzyme.com E-mail: rfischer@l-a-b.com
Region 2 (NJ, NY, PA) Region 10 (OH, MI)

Volunteer Opportunity! Volunteer Opportunity!
Region 3 (CT, NJ, NY) Region 11 (NC, SC, TN, VA)

Mr. Eduardo M. Heidelberg Volunteer Opportunity!
Pfizer
Parlin, NJ 08859 Region 12 (IL, MN, ND, SD, WI)
E-mail: eheidelb@yahoo.com
Dr. Donald S. Ermer
Region 4 (Canada) ASQ Fellow; Eugene L. Grant Medal (2001)
University of Wisconsin—Madison
Mr. Alexander T. C. Lau Madison, WI 53706
ExxonMobil E-mail: Ermer@engr.wisc.edu
Whitby, ON L1R 1R1
E-mail: alex.t.lau@exxonmobil.com
Region 13 (CO, IA, KS, MO, NE, SD, WY)
Region 5 (DC, DE, MD, PA, VA) Volunteer Opportunity!
Mr. Richard A. Litts
Litts Quality Technologies Region 14 (AR, LA, NM, OK, TX, part of
Downington, PA 19335 Mexico)
E-mail: info@littsquality.com Mr. R. Keith Bennett
TRANSCAT
Region 6 (AK, CA, HI, ID, MT, OR, UT, WA, Kingwood, TX 77339
WY) E-mail: kbennett@transcat.com
Volunteer Opportunity!
Region 15 (AL, FL, GA, LA, MS, Puerto Rico)
Region 7 (AZ, CA, NV, part of Mexico)
Mr. E. Bryan Miller
Mr. Randy D. Farmer ASQ Fellow
Metrology Solutions Bryan Miller Consulting
Chula Vista, CA 91913 Florence, AL 35633
E-mail: farmerrd2@cox.net E-mail: milleb@mindspring.com
Region 25 (all other countries)
Region 8 (OH, PA) Volunteer Opportunity!
Dilip A. Shah
E = mc3 Solutions
Wadsworth, Ohio 44281-8215E-mail: em-
c3solu@aol.com, dashah@aol.com
MQD Page 23
The following article starting on page

24 was originally written and presented
at the 2007 NCSL International Work-
shop & Symposium held in St. Paul,
Minnesota this year. We wish to thank
NCSL International and Jay Bucher for
allowing us to reprint his paper in its en-
tirety.
JAY L. BUCHER is president of Bucherview Me-

trology Services, LLC, a consulting company spe-
cializing in quality calibration systems. He is co-
author and editor of The Metrology Handbook
(ASQ Quality Press, 2004), and author of The
Quality Calibration Handbook (ASQ Quality Press,
2007) and Paperless Records – Designing and Cre-
ating Your Own Electronic Forms (Bucherview
Metrology Services, 2007). He is the Treasurer of
the ASQ Measurement Quality Division. Bucher is
a senior member of ASQ and a certified calibration
technician.
A Quality Calibration System
Speaker/Author:
Speaker/Author:JayJayL.
L.Bucher
Bucher
Bucherview Metrology
Promega Services, LLC
Corporation
6700
5445 Royal
East View
Cheryl Dr., DeMadison,
Parkway, Forest, WI
WI53532
53711
Phone: (608)Phone: (608)
277-2522 846-6968
; FAX: (608) 277-2516
Email: Email:
Jay.Bucher@Bucherview-Metrology.com
jay.bucher@promega.com
Abstract
Whether a company is trying for registration to ISO 9000 standards, or accreditation to ISO
17025, or trying to make a good, valid, repeatable measurement – they will need to have a
system of some sort, and it is just as easy to implement a quality system as opposed to a non-
quality system. But what is a quality system? The basic premise and foundation of a good quality
calibration system is to "Say what you do, do what you say, record what you did, check the
results, and act on the difference". Within this quality system are the basics for any calibration or
metrology function: calibration procedures, traceability, uncertainty, calibration records,
environmental controls, out-of-tolerance procedures, etc. How much importance is placed on
each of these areas is usually determined by who your customer is, and what requirements,
standards, or guidelines your calibration program must meet. To this end, a quality calibration
system in its basic form can set the foundation for your policies and procedures.
1. The Requirements
The first area to be discussed is some of the requirements that call for a quality system, records,
calibration, etc. Generally speaking, the hardest requirements are regulations provided by the
FDA (commonly called cGMPs).
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's origins go back to the start of the 20th century, when revelations about
filth in the Chicago stockyards shocked the nation into awareness that, in an industrial economy,
protection against unsafe products is beyond any individual's means. The U.S. Congress
responded to Upton Sinclair's best-selling The Jungle by passing the Food and Drugs Act of
1906 that prohibited interstate commerce in misbranded and adulterated food and drugs.
Enforcement of the law was entrusted to the U.S. Department of Agriculture's Bureau of
Chemistry, which later became the FDA.
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:
x The Federal Food, Drug, and Cosmetic Act of 1938 was passed following the death of 107
persons, mostly children, who took a legally marketed poisonous Elixir of Sulfanilamide.
The FD&C Act completely overhauled the public health system. Among other provisions,
2007 NCSL International Workshop and Symposium

the law authorized the FDA to demand evidence of safety for new drugs, issue standards
for food, and conduct factory inspections.
x The Kefauver-Harris Amendments of 1962, which were inspired by the thalidomide

tragedy in Europe (and the FDA's vigilance that prevented the drug's marketing in the
United States), strengthened the rules for drug safety and required manufacturers to prove
their drugs' effectiveness.
x The Medical Device Amendments of 1976 followed a U.S. Senate finding that faulty
medical devices had caused 10,000 injuries, including 731 deaths. The law applied safety
and effectiveness safeguards to new devices.
Today, the FDA regulates $1 trillion worth of products a year (Feb 2002). It ensures the safety of
all food except for meat, poultry and some egg products; ensures the safety and effectiveness of
all drugs, biological products (including blood, vaccines and tissues for transplantation), medical
devices, and animal drugs and feed; and makes sure that cosmetics and medical and consumer
products that emit radiation do no harm.[1]
Before going into what the current standards and regulations actually state here is a reminder
from times past about measurement practices, and how important they really are.
Immersion in water makes the straight seem bent; but reason, thus confused by false
appearance, is beautifully restored by measuring, numbering and weighing; these drive
vague notions of greater or less or more or heavier right out of the minds of the surveyor,
the computer, and the clerk of the scales. Surely it is the better part of thought that relies
on measurement and calculation. (Plato – The Republic)
There shall be standard measures of wine, beer and corn…throughout the whole of our
kingdom, and a standard width of dyed russet and cloth; and there shall be standard
weights also. (Clause 35, Magna Carta, 1215. Magna Carta (Latin for "Great Charter",
literally "Great Paper"), also called Magna Carta Libertatum ("Great Charter of
Freedoms"), was an English charter originally issued in 1215. Magna Carta is the most
significant early influence on the long historical process that led to the rule of
constitutional law today. Magna Carta was originally created because of disagreements
between the Pope, King John and his English barons about the rights of the King. Magna
Carta required the king to renounce certain rights, respect certain legal procedures and
accept that the will of the king could be bound by law. There are a number of popular
misconceptions about Magna Carta, such as that it was the first document to limit the
power of an English king by law (it was not the first, and was partly based on the Charter
of Liberties); that it in practice limited the power of the king (it mostly did not in the
Middle Ages); and that it is a single static document (it is a variety of documents referred
to under a common name). Magna Carta was renewed throughout the Middle Ages, and
further during the Tudor and Stuart periods, and the 17th and 18th centuries. By the early
19th century most clauses had been repealed from English law. The influence of Magna
Carta outside England can be seen in the United States Constitution and Bill of Rights.
Indeed just about every common law country with a constitution has been influenced by

Magna Carta, making it one of the most important legal documents in the history of
democracy.)
When you can measure what you are speaking about, and express it in numbers, you
know something about it; but when you cannot express it in numbers, your knowledge is
of a meager and unsatisfactory kind. It may be the beginning of knowledge, but you have
scarcely, in your thoughts, advanced to the stage of science. (William Thomson, 1st
Baron Kelvin, GCVO, OM, PC, PRS (26 June 1824–17 December 1907; A.K.A. Lord
Kelvin).[2]
All of the following Code of Federal Regulations (CFR) can be searched for and located at:
http://www.access.gpo.gov/nara/cfr/cfr-table-search.html#page1. Underscore emphasis has
been added. [3]
FDA Regulations
The FDA is the federal agency responsible for ensuring that foods are safe, wholesome and
sanitary; human and veterinary drugs, biological products, and medical devices are safe and
effective; cosmetics are safe; and electronic products that emit radiation are safe. FDA also
ensures that these products are honestly, accurately and informatively represented to the
public.
PART 211--CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED

PHARMACEUTICALS
Subpart D--Equipment
Sec. 211.68 Automatic, mechanical, and electronic equipment.
(a) Automatic, mechanical, or electronic equipment or other types of equipment, including
computers, or related systems that will perform a function satisfactorily, may be used in the
manufacture, processing, packing, and holding of a drug product. If such equipment is so
used, it shall be routinely calibrated, inspected, or checked according to a written program
designed to assure proper performance. Written records of those calibration checks and
inspections shall be maintained.

PHARMACEUTICALS
Subpart I--Laboratory Controls
Sec. 211.160 General requirements.
(4) The calibration of instruments, apparatus, gauges, and recording devices at suitable
intervals in accordance with an established written program containing specific directions,
schedules, limits for accuracy and precision, and provisions for remedial action in the event
accuracy and/or precision limits are not met. Instruments, apparatus, gauges, and recording
devices not meeting established specifications shall not be used.

PHARMACEUTICALS
Subpart J--Records and Reports
Sec. 211.194 Laboratory records.

(a) Laboratory records shall include complete data derived from all tests necessary to
assure compliance with established specifications and standards, including examinations and
assays, as follows:
(8) The initials or signature of a second person showing that the original records have been
reviewed for accuracy, completeness, and compliance with established standards.
(d) Complete records shall be maintained of the periodic calibration of laboratory
instruments, apparatus, gauges, and recording devices required by Sec. 211.160(b)(4).
PART 820--QUALITY SYSTEM REGULATION

Subpart G--Production and Process Controls
Sec. 820.72 Inspection, measuring, and test equipment.
(a) Control of inspection, measuring, and test equipment. Each manufacturer shall ensure
that all inspection, measuring, and test equipment, including mechanical, automated, or
electronic inspection and test equipment, is suitable for its intended purposes and is capable
of producing valid results. Each manufacturer shall establish and maintain procedures to
ensure that equipment is routinely calibrated, inspected, checked, and maintained. The
procedures shall include provisions for handling, preservation, and storage of equipment, so
that its accuracy and fitness for use are maintained. These activities shall be documented.
(b) Calibration. Calibration procedures shall include specific directions and limits for
accuracy and precision. When accuracy and precision limits are not met, there shall be
provisions for remedial action to reestablish the limits and to evaluate whether there was any
adverse effect on the device's quality. These activities shall be documented.
(1) Calibration standards. Calibration standards used for inspection, measuring, and test
equipment shall be traceable to national or international standards. If national or international
standards are not practical or available, the manufacturer shall use an independent
reproducible standard. If no applicable standard exists, the manufacturer shall establish and
maintain an in-house standard.
(2) Calibration records. The equipment identification, calibration dates, the individual
performing each calibration, and the next calibration date shall be documented. These records
shall be displayed on or near each piece of equipment or shall be readily available to the
personnel using such equipment and to the individuals responsible for calibrating the
equipment.
PART 58--GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY

STUDIES
Subpart D--Equipment
Sec. 58.63 Maintenance and calibration of equipment.
(a) Equipment shall be adequately inspected, cleaned, and maintained. Equipment used for
the generation, measurement, or assessment of data shall be adequately tested, calibrated
and/or
standardized.
(b) The written standard operating procedures required under Sec. 58.81(b)(11) shall set
forth in sufficient detail the methods, materials, and schedules to be used in the routine
inspection, cleaning, maintenance, testing, calibration, and/or standardization of equipment,
and shall specify, when appropriate, remedial action to be taken in the event of failure or

malfunction of equipment. The written standard operating procedures shall designate the
person responsible for the performance of each operation.
(c) Written records shall be maintained of all inspection, maintenance, testing, calibrating
and/or standardizing operations. These records, containing the date of the operation, shall
describe whether the maintenance operations were routine and followed the written standard
operating procedures. Written records shall be kept of nonroutine repairs performed on
equipment as a result of failure and malfunction. Such records shall document the nature of
the defect, how and when the defect was discovered, and any remedial action taken in
response to the defect.
PART 58--GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY

STUDIES
Subpart E--Testing Facilities Operation
Sec. 58.81 Standard operating procedures.
(a) A testing facility shall have standard operating procedures in writing setting forth
nonclinical laboratory study methods that management is satisfied are adequate to insure the
quality and integrity of the data generated in the course of a study. All deviations in a study
from standard operating procedures shall be authorized by the study director and shall be
documented in the raw data. Significant changes in established standard operating procedures
shall be properly authorized in writing by management.
(b) Standard operating procedures shall be established for, but not limited to, the
following:
(11) Maintenance and calibration of equipment.
PART 110--CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING,

PACKING, OR HOLDING HUMAN FOOD
Subpart C--Equipment
Sec. 110.40 Equipment and utensils.
(a) All plant equipment and utensils shall be so designed and of such material and
workmanship as to be adequately cleanable, and shall be properly maintained. The design,
construction, and use of equipment and utensils shall preclude the adulteration of food with
lubricants, fuel, metal fragments, contaminated water, or any other contaminants. All
equipment should be so installed and maintained as to facilitate the cleaning of the equipment
and of all adjacent spaces. Food-contact surfaces shall be corrosion-resistant when in contact
with food. They shall be made of nontoxic materials and designed to withstand the
environment of their intended use and the action of food, and, if applicable, cleaning
compounds and sanitizing agents. Food-contact surfaces shall be maintained to protect food
from being contaminated by any source, including unlawful indirect food additives.
(f) Instruments and controls used for measuring, regulating, or recording temperatures, pH,
acidity, water activity, or other conditions that control or prevent the growth of undesirable
microorganisms in food shall be accurate and adequately maintained, and adequate in
number for their designated uses.
PART 606_CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND

BLOOD COMPONENTS
Subpart D Equipment
Sec. 606.60 Equipment.

(a) Equipment used in the collection, processing, compatibility testing, storage and
distribution of blood and blood components shall be maintained in a clean and orderly
manner and located so as to facilitate cleaning and maintenance. The equipment shall be
observed, standardized and calibrated on a regularly scheduled basis as prescribed in the
Standard Operating Procedures Manual and shall perform in the manner for which it was
designed so as to assure compliance with the official requirements prescribed in this chapter
for blood and blood products.
(b) Equipment that shall be observed, standardized and calibrated with at least the
following frequency, include but are not limited to: (refer to the CFR for this table)
(c) Equipment employed in the sterilization of materials used in blood collection or for
disposition of contaminated products shall be designed, maintained and utilized to ensure the
destruction of contaminating microorganisms. The effectiveness of the sterilization procedure
shall be no less than that achieved by an attained temperature of 121.5 [deg]C (251 [deg]F)
maintained for 20 minutes by saturated steam or by an attained temperature of 170 [deg]C
(338 [deg]F) maintained for 2 hours with dry heat.
PART 606--CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND

BLOOD COMPONENTS
Subpart F--Production and Process Controls
Sec. 606.100 Standard operating procedures.
(b) Written standard operating procedures shall be maintained and shall include all steps
to be followed in the collection, processing, compatibility testing, storage, and distribution of
blood and blood components for transfusion and further manufacturing purposes. Such
procedures shall be available to the personnel for use in the areas where the procedures are
performed. The written standard operating procedures shall include, but are not limited to,
descriptions of the following, when applicable:
(15) Schedules and procedures for equipment maintenance and calibration.
PART 606--CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND

BLOOD COMPONENTS
Subpart I--Records and Reports
Sec. 606.160 Records.
(b) Records shall be maintained that include, but are not limited to, the following when
applicable:
(5) Quality control records:
(i) Calibration and standardization of equipment.
(7) General records:
(iv) Maintenance records for equipment and general physical plant.
According to the CGMP regulations, equipment must be qualified, calibrated, cleaned, and
maintained to prevent contamination and mix-ups (§§ 211.63, 211.67, 211.68). Note that the
CGMP regulations require a higher standard for calibration and maintenance than most
generic quality system models. The CGMP regulations place as much emphasis on process
equipment as on testing equipment (§ 211.42(b)), while most quality systems focus only on
testing equipment.

CHAPTER I--FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF
TRANSPORTATION
SUBCHAPTER G--AIR CARRIERS AND OPERATORS FOR COMPENSATION OR
HIRE: CERTIFICATION AND OPERATIONS
PART 121_OPERATING REQUIREMENTS: DOMESTIC, FLAG, AND
SUPPLEMENTAL OPERATIONS
Subpart L Maintenance, Preventive Maintenance, and Alterations
Sec. 121.369 Manual requirements.
(b) The certificate holder's manual must contain the programs required by Sec. 121.367
that must be followed in performing maintenance, preventive maintenance, and alterations of
that certificate holder's airplanes, including airframes, aircraft engines, propellers, appliances,
emergency equipment, and parts thereof, and must include at least the following:
(5) Procedures, standards, and limits necessary for required inspections and acceptance
or rejection of the items required to be inspected and for periodic inspection and calibration
of precision tools, measuring devices, and test equipment.
PART 145_REPAIR STATIONS

Subpart E Operating Rules
Sec. 145.211 Quality control system.
(c) A certificated repair station must prepare and keep current a quality control manual in a
format acceptable to the FAA that includes the following:
(viii) Calibrating measuring and test equipment used in maintaining articles, including
the intervals at which the equipment will be calibrated; and
2. The Basics
One should keep in mind that calibration is a process (procedures, records, analysis,
communication when test equipment is out of tolerance, etc.), not an event. Each calibration is an
action that takes place once for that particular item, but it continues to be repeated time and time
again. The data can be used for many functions, to include: calibration interval analysis,
alert/action procedures, statistical analysis, to see if processes are or are not functioning properly,
and limited calibrations to name just a few. This is all part of a mind set by calibration
practitioners from technicians to supervisors to management. It’s a critical and necessary process
that could make the difference between life and death, profit and bankruptcy, and good or bad
products.
The basic premise and foundation of a quality calibration system is to "Say what you do, do what
you say, record what you did, check the results, and act on the difference". Let’s break these
down into simple terms that will be discussed in great detail in the following chapters.
"Say what you do" means write in detail how to do your job. This includes calibration
procedures, standard operating procedures (SOPs), protocols, work instruction, and/or work
cards. Companies use different names for their procedures, but the bottom line is that they must

have procedures. What is in those procedures is specifically called out in various regulations,
recommended practices or procedures.
"Do what you say" means follow the documented procedures or instructions every time you
calibrate, or perform a function that follows specific written instructions. The requirements for
following written procedures is spelled out every where you look. It only makes sense that if you
are required to have written procedures, then you must follow them. Why is this so important?
Simply put, if repeatable, reliable, and traceable calibrations are to be performed, the calibration
must be performed the same each and every time. This can only happen when a specific set of
instructions are followed. Deviation from those instructions does not allow for repeatable
calibrations.
In order to compare historical data on a piece of test equipment, one must be able to compare
apples to apples and oranges to oranges. Not apples to oranges. If different standards were used
(having different tolerances – different standards may be used for identical calibrations, but
during substitution of standards, their specifications must be equal, or better than those of the
substituted standard(s); that had lesser tolerances, the resulting readings could not be compared.
"Record what you did" means that you must record the results of your measurements and
adjustments, including what your standard(s) read or indicated both before and after any
adjustments might be made. This is also spelled out in different regulations.
"Check the results" means make certain the test equipment meets the tolerances, accuracies, or
upper/lower limits specified in your procedures or instructions. Depending on your industry, you
may only have to ensure that test equipment meets a set of tolerances or specifications. However,
the vast majority of requirements in the calibration community specify that the data be collected
and stored. This requirement has many advantages over just ensuring a tolerance is met. Data
retrieval for comparison, statistical analysis, or to be used for calibration interval analysis can not
be met if the data is not available. Just to say that a tolerance was met is no longer the preferred
way of performing calibrations.
"Act on the difference" means if the test equipment is out of tolerance, does not meet the
specified accuracies, or exceeds the upper/lower test limits written in your procedures, you’re
required to inform the user/owner of the equipment because they may have to re-evaluate
manufactured goods, change a process, or recall a product. The worse case scenario is that
previously calibrated equipment that used that particular standard must be recalled and
recalibrated, along with any products that used any of the suspect test equipment. This could
become costly and very time consuming if procedures are not in place for reverse traceability.
"Say what you do, do what you say, record what you did, check the results, and act on the
difference" form the foundation for a quality calibration system. However, one must build on that
foundation to ensure it works properly. Part of any system is the function used to update your
procedures, records and quality system. Documentation control is critical to having the correct,
up-to-date procedure in place, when it is needed; and a calibration technician who is trained on
that procedure, and any changes or modifications to it. All of this requires controls,
documentation, and training. Where does it say this?

According to ANSI/ISO/IEC 17025-2005, chapter 4.3, Document control: “The laboratory shall
establish and maintain procedures to control all documents…all documents issued…shall be
reviewed and approved. A master list…identifying the current revision status and distribution of
documents in the quality system shall be established. Changes to documents shall be reviewed
and approved…”. Q9001-2000, chapter 4.2.3, Control of documents states: “Documents required
by the quality management system shall be controlled. A documented procedure shall be
established to define the controls needed to approve documents…review and update…ensure
that changes are identified…that relevant versions are available…to prevent the unintended use
of obsolete documents…”. And Z540 states in chapter 5.2: “The quality manual and related
documentation shall also contain d) procedures for control and maintenance of documentation.”
One of the most important parts of a quality system should be the document control procedures.
How do you control who makes changes, how new documents and/or changes to old documents
get posted, and when are the users notified or made aware that changes have been made? There
are software packages available that can assist in controlling an organization’s document system,
but a small business may not be able to afford those packages. Here’s a brief overview of what
can be done with the resources an organization may already be using.
Each of your controlled documents (procedures, records, certificates, etc.) should have a unique
identification (many systems use a number often known as a control number) as well as a
revision number. A master list with all this information should be available for anyone to see
what the current documents are within their quality system. This list should also include the
revision date of the document. It needs to be updated every time changes are made and approved
for your documents. A simple spreadsheet or word processor document can fulfill this
requirement, as long as it is updated and maintained. And, it has to be available to the technicians
who use the various procedures, records and certificates. This isn’t a difficult problem in a small
group where only a few people work with the various documents. But if an organization has two
or three shifts, different locations, or off-site calibration responsibilities, the opportunity for
using out of date or incorrect documents could easily become a problem. Notification of changes
and training, when applicable, should be documented as a form of keeping everyone informed
and up-to-date. Part of an organization’s training program should include when and how to
inform and train its staff of changes to their documents. Some organizations ensure training
and/or notification of changes has occurred before they allow the latest revisions to be posted. In
some systems, the new revision must be posted in order for the user to have access to the
documents. Another approach would be to maintain all of your quality documentation
electronically via an intranet. In this process any printed documents would be invalid. This
process insures only the “latest and greatest” procedures are available to all that they pertain to.
Whichever way an organization’s system works, it is vital that everyone involved be informed
and trained when changes are made, and that only the latest revisions are available for their use.
As a minimum, an organization’s master list should have, for each of its controlled documents: a
unique identification, document name, revision or edition number, and revision date. In addition
it is helpful to include the name of the approver or approval authority, and something stating that
only the revisions listed should be used. Archiving a copy of previous revisions can have
benefits, but must be in a location where they cannot be readily accessed for use by staff. Some
systems use black lines in their borders to indicate where changes have been made; others

annotate the changes in a reference section at the end of the document; and still others refer to
comparisons of archived documents as the only reference to changes. No matter which system or
combination of systems, are used, they only need to meet the quality system requirements that
have been set for the organization. [4]
3. Calibration Procedures (say what you do; do what you say)
By definition – A calibration procedure is a controlled document that provides a validated

method for evaluating and verifying the essential performance characteristics, specifications or
tolerances for test 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 (called ‘As Found’ readings) and after (called ‘As
Left’ readings) adjustments; and information sufficient to determine if the unit under calibration
is operating within the necessary performance specifications.
It matters little what name is given to this part of your quality calibration system. Calibration
procedure, Standard Operating Procedure (SOP), protocol, work instructions, work cards, or any
number of other monikers. The bottom line is they are used to tell a person how to calibrate a
particular piece of test equipment.
There should be three parts to this system. The first part is the procedure itself. How it is written
and what it contains. The second part is the control system used to ensure that changes, updates,
and modifications to the calibration procedure are implemented. It is not good enough to have
the procedures if there is no way to continuously improve it. Nothing is written in stone, and
most certainly not calibration procedures. Changes are made every day to the standards used,
updates from the manufacturer, new modifications to old items, and many other reasons to
continuously improve your procedures. There must be a process in place to make the changes,
update the written procedures that the calibration technicians use, and to inform and train them
on the improvements and/or changes. Also, when errors are found, the procedure needs to be
changed, too.
The third part is the most critical. The calibration procedure must be used each and every time a
calibration is performed. This is important enough to repeat: The calibration procedure must
be used each and every time a calibration is performed. Every standard and regulation calls
for the use of calibration procedures. They do not say that they have to be made available, but
that they will be used.
This is where the real world collides with the standards and regulations. Everyone who has
performed numerous calibrations on a particular piece or type of test equipment over many years
will be thinking to themselves: “I’ve done this a million times – why do I need to look at the
same old procedure?” Is it possible the procedure has changed? Is it possible the standards used
have changed? Is it possible the item being calibrated has changed? They are all possibilities. But
the question in most calibration technician’s minds is this…If I know what I am doing, why do I
have to re-read a procedure that I know by heart?

The nice part of ISO and other standards is that nobody has to memorize or “know” many things.
The one thing they must know is where to find the information when needed. The information on
performing any particular calibration is written in a calibration procedure. That calibration
procedure must be with the calibration technician when they are performing the calibration. In
order to perform the calibration without being supervised, there must be documentation stating
that the calibration technician is proficient in doing that task. If the calibration technician is
signed off as being able to perform unsupervised calibrations, that is step one. Step two is to
have all the required tools and documents available to perform the task. One of those
requirements is the calibration procedure. It must be in the general area with the technician when
they are performing the calibration. An auditor does not expect the experienced calibration
technician to constantly refer to the procedure each and every time they perform a calibration.
However, they are expected to know where to find something within the calibration procedure if
there are any questions about what is being accomplished. This is where the experienced
calibration technician knows what is in the procedure, can easily turn to the correct page, and can
show they are performing the step as written in the procedure. If they cannot do this, they should
be following the procedure step by step on every calibration.
Humans are creatures of habit. They get into a groove and don’t want to make changes. This is
part of why it is critical to ensure that every time a change is made to a calibration procedure, it
is documented, and every calibration technician is trained on what the change is, and how to
correctly perform the new procedure.
A calibration procedure is only as good as what’s written on its pages, and the calibration
technician who follows them. In order to have repeatable, reliable, accurate measurements with
test equipment, each item must be calibrated the same way. This can only be accomplished by
using, and following validated calibration procedures each and every time a calibration is
performed.
All quality systems that address calibration require written instructions for the calibration of test
equipment. Under the quality system, this is the "Say what you do" portion, which means you
need to write down in detail how to do your job (this includes calibration procedures, SOPs,
protocols, work instruction, work cards, etc.) Why do you need to follow formal instructions or
procedures? Simple…in order to get consistent results from a calibration, you must be able to
follow step-by-step instructions each and every time you perform those calibrations.
The following is paraphrased from three different sources focusing on written calibration
procedures: ISO 10012:2003, Measurement management systems – Requirements for
measurement processes and measuring equipment; NCSL International’s RP-6, Calibration
Control Systems for the Biomedical and Pharmaceutical Industry; and ANSI/ASQ M1-1996,
American National Standard for Calibration Systems. Another source is NCSL International’s,
RP-3, Calibration Procedures.
ISO 10012:2003, chapter 6.2.1 states: “Measurement management system procedures shall be
documented to the extent necessary and validated to ensure the proper implementation, their
consistency of application, and the validity of measurement results. New procedures or changes

to documented procedures shall be authorized and controlled. Procedures shall be current,
available and provided when required.”
NCSLI RP-6 states in chapter 5.9 Calibration Procedures, starting on page 10: “Documentation
should be provided containing sufficient information for the calibration of measurement
equipment.” The Requirements in 5.9.1 are:
x Source (The calibration procedure may be…prepared internally, by another agency, by

the manufacturer, or by a composite of the three)
x Completeness (The procedure should contain sufficient instruction and information to
enable qualified personnel to perform the calibration)
x Approval (All procedures should be approved and controlled…Evidence should be
displayed on the document)
x Software (…used instead of an actual procedure should follow the computer software
recommendation for control)
Under Format in chapter 5.9.2 internal procedures should include:
x Performance requirements (device description, manufacture, type or model number,

environmental conditions, specifications…)
x Measurement standards (generic description of measurement standards and performance
requirements, accuracy ratio and/or uncertainty, and any auxiliary tools)
x Preliminary operations (any safety or handling requirements, cleaning prerequisites,
reminders or operational checks)
x Calibration process (the detailed set of instructions for process verification in well-
defined segments…upper and lower tolerance limits, and required further instructions)
x Calibration results (performance results data sheet or form to record the calibration data
when required)
x Closing operations (any labeling, calibration safeguards, and material-removal
requirements to prevent contamination of product)
x Storage and handling (…requirements to maintain accuracy and fitness for use)
And chapter 5.9.3, Identification states: “For reference purposes, a system should be established
for identifying calibration procedures.”
And finally, M1-1996, chapter 4.9 states: “Documented procedures, of sufficient detail to ensure
that calibrations are performed with repeatable accuracy, shall be utilized for the calibration of
all ensembles.” That explains it all in one sentence. (This standard describes a calibration system
as an “ensemble”.)
Now that you know what the standards require for calibration procedures, where do you go from
here? Some companies use Original Equipment Manufacturer (OEM) procedures that are in their
service manuals as a starting point. Please keep in mind that a lot of the service manuals have
procedures for adjusting the IM&TE as well as (or instead of!) the calibration (performance
verification) process. Also, some OEM procedures are vague and lack specific requirements
needed to insure a good calibration, such as equipment requirements, environmental conditions

and so on. Finally, in many cases the equipment manufacturer simply does not provide any
calibration or service information as a matter of policy. By writing your own procedures, or
using pre-written calibration procedures, you might save time by eliminating the adjustment
process if it is not required and/or improve the outcome of the calibration.
With regard to adjusting IM&TE, there are several schools of thought on the issue. On one end
of the spectrum, some (particularly government regulatory agencies) require that an instrument
be adjusted at every calibration, whether or not it is actually required. At the other end of the
spectrum, some hold that any adjustment is tampering with the natural system (from Deming)
and what should be done is simply record the values and make corrections to measurements.
An intermediate position is to adjust the instrument only if (a) the measurement is outside the
specification limits; or (b) if the measurement is inside but near the specification limits, where
“near” is defined by the uncertainty of the calibration standards; or (c) if a documented history of
the values of the measured parameter shows that the measurement trend is likely to take it out of
specification before the next calibration due date. [5]
4. Calibration Records (record what you did; check the results)
One might think of record keeping as a three-pronged approach: the calibration record
(electronic or hard copy), the calibration label (which has the date calibrated, next due date,
name of calibration technician, and a unique identification number of the test equipment), and
the calibration software record (let’s call it CAMS – Calibration Automated Management
System). Each is required in a quality calibration system, and performs a critical function by
itself.
Give full accounting of how to use Adobe Acrobat Professional software to make electronic
records and how they meet 21CFR part 11 requirements as well as anything that ISO might have.
Explain how either Standard or Pro must be used to fill in the form in order to keep the form and
data electronically, other wise they can be filled in using Reader, and printed for filing as a hard
copy.
Here’s a short list of where you can find specific requirements for documenting your calibrations
through the use of records.
1. ANSI/ISO/IEC 17025:2005(E), paragraph 4.13.2.1 states: “The laboratory shall retain

records of original observations, derived data and sufficient information to establish an audit.
Trail, calibration records, staff records and a copy of each test report or calibration certificate
issued, for a defined period.”1
2. ISO 10012:2003, chapter 6.2.3 states: “Records containing information required for the
operation of the measurement management system shall be maintained. Documented
procedures shall ensure the identification, storage, protection, retrieval, retention time and
disposition of records.”
3. NCSLI RP-6, chapter 5.6 Records states: “Records should be maintained for all measurement
and test equipment that is included in the calibration system.”

4. M1-1996, chapter 4.7 Records states: “…records shall include, but not be limited to…a.
Description of equipment and unique identification; b. Date most recent calibration was
performed; c. Indication of procedure used; d. Calibration interval; e. Calibration results
obtained (i.e., in or out of tolerance); f. By whom the ensemble was calibrated; and g.
Standards used. Specific record requirements for other standards or regulations can be found
in chapter 2.11 Industry specific requirements.
5. 21 CFR Sec. 820.72 Inspection, measuring, and test equipment.
(b) Calibration. Calibration procedures shall include specific directions and limits for
accuracy and precision.
a. Calibration standards. Calibration standards used for inspection, measuring, and test
equipment shall be traceable to national or international standards.
2) Calibration records. The equipment identification, calibration dates, the individual
performing each calibration, and the next calibration date shall be documented.
By following the guidance in section 5.6, Records, of the National Conference of Standards
Laboratories (NCSL) International’s RP-6, Calibration Control Systems for the Biomedical and
Pharmaceutical Industry, you can decide what is needed for your particular business
requirements. There are four basic areas that need to be covered on every form: identification,
location, calibration history, and traceability documentation. Here is a brief explanation of how a
company could fill these requirements.
Identification: Use a five digit system, where a unique number is assigned to every piece of test
equipment that you support, using a chemical and abrasive resistant bar code label, attached
where it can be easily read on the unit. This 'Metrology ID number' matches the number used in
CAMS, software for tracking, data collection, and historical record keeping.
Location: List the location of each item in CAMS by its room number and the department to
which it is assigned. Since your technicians may go to each laboratory or room to calibrate
and/or repair each piece of test equipment, the criticality of easily finding each item can not be
over emphasized. It has been found that a waste of manpower is spent in searching for test
equipment that has been moved to a new location, and notification is not given so that you can
update our database. Having the location in your database also allows for easy sorting by area as
the need arises, such as when doing like items that are coming due for calibration during a
specific time period. This equates to working smarter, not longer.
Calibration history: Record on each form when the unit was last calibrated, the new calibration
date, and when it will next be due calibration. Show what the working or reference standard read,
as well as the 'As Found', and when needed, 'As Left' readings of the test instrument. The
standards used are identified by their ID number, range and tolerances, and when they are next
due for calibration. Use check boxes to indicate if the test instrument passed or failed its
calibration. Identify the calibration procedure used for that particular calibration. And last but not
least, have a place for the calibration technician to sign and date the form.
Traceability documentation: On every form have a traceability statement identifying your

unbroken chain of comparisons back to NIST. Strictly adhere to using a 4:1 ratio of uncertainty,

and so state in our quality system and procedures (if that is the route your calibration system is
using for traceability).
In order for a record to be valid, it must:

1. Identify which test equipment it is recording data on
x Have a unique identification number assigned to it
x Identify who owns it (when appropriate)
x Test equipment part or manufacturer’s number
x Test equipment serial number and/or asset number if applicable
x Location (when appropriate). If it is for internal use only, possibly show the
department, group or cost center that owns it, and the calibration interval assigned to it
2. The environmental conditions during calibration are sometimes required and need an area
on the record
3. List the instrument’s ranges, and tolerances (when applicable or require)
4. Show traceability for the standards you are using to perform the calibration by identifying
your standards and when they are currently due calibration
5. List the procedure used for that particular calibration, and the revision number
6. List your standard’s tolerances and/or traceability information
7. Area for recording the standard’s readings, as well as what the test equipment read (this is
what is known as the ‘As Found’ readings). And you will need an area for the ‘As Left’
readings, those readings taken after repair, alignment or adjustment of the unit. When
required, the out-of-tolerance readings may be given in magnitude and direction in order
to make an impact assessment.
8. List the next ‘Date Due Calibration’ if required.
9. An area for comments or remarks when clarification of limits, repairs or adjustments that
occurred during the process of calibration is required
10. The person performing the calibration is usually required to date and sign the record
x The date will be when all calibration functions have been completed. Some items take
more than a day to calibrate, and when this occurs, the final day of calibration is the
calibration date, and also the date used for calculating when it is next due for
calibration
x Some organizations have a requirement for a ‘second set of eyes’ to audit, perform a
quality assurance function, or just ensure all the data is present. Whatever the case may
be, there needs to be a place for their signature and possibly date accomplished.[6]
5. It’s Out-of-Tolerance (act on the difference)
When test equipment is found to be out of tolerance during calibration (or when it comes in for
repair or adjustment, and an “as found” calibration is performed and an out of tolerance
condition is recorded), your quality calibration program must have a system in place for
notification, recall, root cause analysis, etc.
Within your quality system, does it make a difference how far out of tolerance the test equipment
is before anyone gets notified? What documentation is involved, and who is responsible for
starting the process? How is test equipment recalled? Who determines if product must be
recalled? A lot of questions, and for most calibration departments, not enough answers.

When performing a calibration and a step does not meet the specified tolerances, the calibration
must be continued till all parameters have been calibrated (compared against your standard).
Make a note about the out of tolerance step by recording what the test instrument read, and what
the standard read. But the entire calibration must be accomplished. Here is why. If the calibration
is stopped at that point and an adjustment is made, it is possible that the adjustment could affect
other parts of the calibration, both to measurements that have already been made, or have yet to
be done. If they have not been done yet, they could show up as in tolerance, when in fact they
were out of tolerance before the adjustment, and it would not be possible to inform the user of
this out of tolerance condition. Or just as bad, they could show as out of tolerance when they
were originally within tolerance and the user has to make a false recall or do-over because of bad
data.
Here are some examples from the federal regulations on requirements when test equipment is
found to be out of tolerance:
Sec. 211.160 General requirements.

(b)(4) The calibration of instruments, apparatus, gauges, and recording devices at suitable
intervals in accordance with an established written program containing specific directions,
schedules, limits for accuracy and precision, and provisions for remedial action in the event
accuracy and/or precision limits are not met. Instruments, apparatus, gauges, and recording
devices not meeting established specifications shall not be used.
Sec. 820.72 Inspection, measuring, and test equipment.

(b) Calibration. Calibration procedures shall include specific directions and limits for accuracy
and precision. When accuracy and precision limits are not met, there shall be provisions for
remedial action to reestablish the limits and to evaluate whether there was any adverse effect on
the device's quality. These activities shall be documented.
Sec. 58.63 Maintenance and calibration of equipment.

(c) Written records shall be maintained of all inspection, maintenance, testing, calibrating and/or
standardizing operations. These records, containing the date of the operation, shall describe
whether the maintenance operations were routine and followed the written standard operating
procedures. Written records shall be kept of nonroutine repairs performed on equipment as a
result of failure and malfunction. Such records shall document the nature of the defect, how and
when the defect was discovered, and any remedial action taken in response to the defect.
As clearly written in the federal regulations, whenever something is found to be out of tolerance,
it will be recorded, and any remedial action shall also be recorded. As a minimum, the “as
found” reading from the test instrument, as well as what the working or reference standard read,
along with the “as left” reading, after the test instrument was repaired and/or adjusted.
Any additional information that an organization keeps, in what format it is retained, and how the
record is archived is up to their management. [7]
Over the years, I’ve seen quality systems referred to in many forms and variations. For me, this
is the easiest and most accurate way to think of a quality system used for calibration in any

organization that wants quality, accuracy, reproducibility, and traceability with their test
equipment. As with anything in life, there is more than one way to skin a cat – this is just one of
several ways to look at a quality system. The important thing to remember is this…a quality
system is required if reproducible results are the desired product in any environment.
References
1. J. L. Bucher, Chapter 1 in The Quality Calibration Handbook: Developing and Managing a

Calibration Program, ASQ Quality Press, Milwaukee, 2007, pp. 4.
Calibration Program, ASQ Quality Press, Milwaukee, 2007, pp. 9.
Calibration Program, ASQ Quality Press, Milwaukee, 2007, pp. 9 - 19.

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Vol. 21, No.

2007 NCSL International Workshop & Symposium

THE MEASUREMENT QUALITY DIVISION (MQD)

CHAIR’S CORNER participation will come in many forms such as sur-

At the Measurement Science Conference in Ana- Sincerely,

As a division sponsor of the CCT Exam Body of

SMSgt Woody Niemann

The latest CCT exam statistics

CCT PROGRAM UPDATE

· Name and location of the military base

Information on ASQ’s CCT program can be found at:

CCT exam application information may be found at:

Information on other ASQ certification programs can be found at:

ASQ MQD MEETING AT NCSLI CONFERENCE – JULY 2007

(Continued from page 7)

THE LEARNING CURVE had been introduced by the French Revolutionists

(Continued from page 9) tific research, and of educational institutions. These

(Continued from page 10)

1. Your answers must be in my hands (not just

SERVING INTERNATIONAL TRADE FOR 15 YEARS

To learn more about APLAC, please visit www.aplac.org.

Submitted by: Hershal C. Brewer, CCT

Further information about ILAC is available from the website at:

AB Liaison Report products in Oregon.

IAS: IAS Vice President Patrick McCullen participated

(Continued from page 14) NVLAP:

A2LA has developed a new Information Technol-

For additional information regarding this program,

NCSLI 2007 Report

(Continued from page 16)

Chris Grachanen receiving his Certificate of Appreciation

(Continued on page 18)

(Continued from page 17)

Chris Grachanen’s Certificate of Appreciation

CHECK STANDARDS CAN SAVE YOU TIME

The benefits of employing check standards as a way of monitoring measure-

(Continued from page 18)

(Continued on page 20)

MEASUREMENT QUALITY DIVISION OFFICERS AND COMMITTEE CHAIRS

Immediate Past Chair

Joe Simmons Scholarship

ASQ MEASUREMENT QUALITY DIVISION REGIONAL COUNCILORS

Regional Councilors represent the Division to members and Sections in their

Region 2 (NJ, NY, PA) Region 10 (OH, MI)

Region 3 (CT, NJ, NY) Region 11 (NC, SC, TN, VA)

The following article starting on page

JAY L. BUCHER is president of Bucherview Me-

2007 NCSL International Workshop and Symposium

x The Kefauver-Harris Amendments of 1962, which were inspired by the thalidomide

2007 NCSL International Workshop and Symposium

PART 211--CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED

PART 211--CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED

PART 211--CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED

2007 NCSL International Workshop and Symposium

PART 820--QUALITY SYSTEM REGULATION

PART 58--GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY

2007 NCSL International Workshop and Symposium

PART 58--GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY

PART 110--CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING,

PART 606_CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND

2007 NCSL International Workshop and Symposium

PART 606--CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND

PART 606--CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND

2007 NCSL International Workshop and Symposium