The Standard Sep07

Vol. 21, No. 3 The Newsletter of the Measurement Quality Division, American Society for Quality September 2007

2007 NCSL International Workshop & Symposium2007 NCSL International Workshop & Symposium St. Paul River Centre, St. Paul, MinnesotaSt. Paul River Centre, St. Paul, Minnesota

July 29 ~ August 2, 2007July 29 ~ August 2, 2007 Below: Dilip Shah, Chris Grachanen, Jay Bucher, Woody Niemann, & Graeme PayneBelow: Dilip Shah, Chris Grachanen, Jay Bucher, Woody Niemann, & Graeme Payne

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-mation intended for publication can be sent via electronic mail as an attachment in MS Word format (Times New Roman, 11 pt). Use single spacing between sen-tences. Graphics/illustrations must be sent as a separate attachment, in jpg format. Photographs of MQD activities are always welcome. Publication of articles, prod-uct releases, advertisements or technical information does not imply endorsement by MQD or ASQ. While The Standard makes every effort to ensure the accuracy of articles, the publication disclaims responsibility for statements of fact or opinion made by the authors or other contributors. Material from The Standard may not be reproduced without permission of ASQ. Copyrights in the United States and all other countries are reserved. Website information: MQD’s homepage can be found at http://www.asq.org/measure. © 2007 ASQ, MQD. All rights reserved.

The Standard Vol 21, No. 3, September 2007

Managing Editor and Publisher Jay L. Bucher 6700 Royal View Dr. De Forest, WI 53532-2775 Voice: 608-846-6968 Email: [email protected]

Advertising Submit your draft copy to Jay Bucher, with a request for a quotation. Indicate size desired. Since The Standard is published ‘in-house’ the requester must submit a photo or graphic of their logo, if applicable. The following rates apply:

Business card size ............................ $100 1/8 page .......................................... $150 1/4 page ........................................... $200 1/3 page ........................................... $250 ½ page ............................................. $300 Full page ......................................... $550

Advertisements will be accepted on a ‘per issue’ basis only; no long-term contracts will be available at present. Advertising must be clearly distinguished as an ad. Ads must be related to measurement quality, quality of measurement, or a related quality field. Ads must not imply endorsement by the Measure-ment Quality Division or ASQ.

Letters to the Editor The Standard welcomes letters from mem-bers and subscribers. Letters should clearly state whether the author is expressing opin-ion or presenting facts with supporting infor-mation. Commendation, encouragement, constructive critique, suggestions, and alter-native approaches are accepted. If the con-tent is more than 200 words, we may delete portions to hold that limit. We reserve the right to edit letters and papers. Information for Authors The Standard publishes papers on the qual-ity of measurements and the measurement of quality at all levels ranging from relatively simple tutorial material to state-of-the-art. Papers published in The Standard are not referred in the usual sense, except to ascer-tain that facts are correctly stated and to as-sure that opinion and fact are clearly distin-guished one from another. The Editor re-serves the right to edit any paper. Please sin-gle space after sentences and use Times New Roman, 12 pt font.

TABLE OF CONTENTS MQD Officers for 2007 ~ 2008 ......................................................3 Chair’s Column...............................................................................4 Chair-Elect’s Column .....................................................................5 Important CCT Program Update Information.................................6 MQD Meeting Minutes...................................................................7 The Learning Curve ........................................................................9 APLAC Turns 15 Years Old.........................................................12 ILAC Celebrates 30 Years ............................................................13 AB Liaison Report ........................................................................14 NCSL International Workshop & Symposium Report .................16 Check Standards Can Save You Time ..........................................18 MQD Officers and Committee Chairs ..........................................21 MQD Regional Councilors …………………………………… ..22 A Quality Calibration System.......................................................24

FROM THE DESK OF THE EDITOR/PUBLISHER

It’s hard to believe we have gone through another fiscal year at the MQD. We had a very successful showing at this year’s NCSL International Work-shop and Symposium in St. Paul, Minnesota (a photo of the venue is on the cover). Lots of traffic at our booth, as well as many questions about the MQD, the CCT (certified calibration technician) program, and the CCT challenge coin. By the way, 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 now. If you have your CCT but have not received a CCT challenge coin, please send me an email and we will see what we can do to rectify the situation. If you look closely on the cover, to the left of the ASQ logo are two small ovals. They are the front and back of the CCT challenge coin for booth visitors to envy. We are still actively soliciting articles for future edi-tions of The Standard. They could be original, from past conferences or previously published (we need the appropriate permissions, of course) in other magazines or newsletters.

MQD Page 3


THE MEASUREMENT QUALITY DIVISION (MQD) OFFICERS FOR 2007 ~ 2008 ChairChair

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: [email protected], [email protected]

ChairChair--electelect Craig (Woody) Niemann 1489 Pheasant Run Dr. Newark, OH 43055-8046 Voice (740) 788-5034 E-mail: [email protected]

SecretarySecretary 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: [email protected]

TreasurerTreasurer 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: [email protected]

MQD Page 4


CHAIR’S CORNER By Dilip Shah

Welcome to the Fall 2007 MQD newslet-ter. I was asked to fill in as Interim Chair of the Division and I have accepted the responsibility. Due to increasing work com-mi t men t s , R i ck Roberson thought it best for the division to step down as Chair. I want to thank Rick Roberson for his

past contribution to the division and wish him the best for the future. I am no stranger to the Chair role of the MQD as I fulfilled that role for the 2003-2005 terms. In between, I was active as the Program Chair and I will fulfill that role as well in my current capacity. The Division continues to grow in many different ways. It is strong and we have a good name recog-nition with other professional societies with which we partner in many activities. It is a good thing to partner with other professional organizations where we have common goals. Our participation in the NCSLI conference in Au-gust was superb. It was good to see 7 out of 8 au-thors of The Metrology Handbook at the confer-ence. That means that one lucky conference raffle winner got a copy of The Metrology Handbook with the 7 autographs. Out MQD booth got a lot enquiries about the CCT exam. At the Measurement Science Conference in Ana-heim in March 2008, we are going to sponsor a CCT refresher workshop followed by the ASQ ad-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

participation will come in many forms such as sur-vey input, BOK review, item writing, item review, exam review etc.. Please let us know how you can help. One of the many challenges we face today is to figure out who is going to replace our aging work-force. This problem is common in almost all pro-fessions. It is a global problem, but even more so in a developed country like ours. We have partici-pated in the Education & Training efforts of the NCSLI in this activity. Within the E & T, there are many sub committees that we contribute to. We would love to hear from you and how you are help-ing to solve this issue in your area of work. This is your division. Please let us know how we are doing, what kind of projects and initiatives you would like the division to get involved in, and more importantly, how you can contribute. As a volunteer organization, its success depends on the contribution by its volunteers. I would like to thank all our current volunteers for their steadfast sup-port. But, we must have new ideas that can only come from fresh voices. We are always looking for dedicated volunteers, contributors of articles to The Standard and our sponsored column “Measure for Measure” in the ASQ’s flagship magazine, The Quality Progress. Personally, I feel that volunteer-ing gives me the satisfaction of doing the things I want to do away from the pressures of normal work. The satisfaction of working with like minded individuals, exchanging ideas, learning to be a bet-ter manager has great benefits on my personal and professional life. I am excited for the coming year and am looking forward to serving the division. Sincerely, Dilip

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 [email protected]

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 Christopher L. Grachanen

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 [email protected] 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 • Deadline for article submittal for the next issue of The Standard is 15 Aug 2007. • ASQ headquarters has a new Division Accountant, Bobbie Mulhall. • Jay is working on his replacement for his MQD Treasury position which comes to term next year. • Jay questioned who will be the MQD chair elect for 2008-2009. Discussions followed with no firm candidate identified. • 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 • ASQ’s World Wide Conference abstract submittal deadline is 01 Aug 2007. Dilip and Graeme Payne have submitted their abstracts. • The MQD session track for the 2008 Measurement Science Conference (MSC) has been confirmed. The 2008 MSC will be held on 10-14 March. • 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). • 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 • Update on the CCT program (CCT alumni is now 811 strong). • 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. • 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


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 • 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. • 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, Christopher L. Grachanen ASQ MQD Secretary

(Continued from page 7)

MQD Page 9


THE LEARNING CURVE By Phil Painchaud

This is the fifty-first iteration in an uninterrupted contiguous series of discantive dissertations charted to be on the general sub-ject of Metrology Education. We are now about to commence our sixteenth year of writing these open letters to our es-teemed Boss, the Managing Editor of this journal. We shall

attempt in this iteration to remain close to our charted subject which occasionally we cannot do to the necessity of updating our readers (if any) of breaking news items of metrological interest, or to the lack of current viable inputs on the subject from our reader, Dear Boss: Awhile back, in Column 48 to be precise, I offered a prize of $100.00 to whomever among our readers could answer a question I had asked in Column 46: “ WHO WAS THOMAS BUGGE AND WHAT WAS HIS CONTRIBUTION TO METROL-OGY?” I set a time limit that all answers had to be in my hands by January 2, 2007, and I also speci-fied that all answers must be in writing — US mail or FAX—no phone calls or e-mail. Well for six months nobody answered me. Finally, during June I received an e-mail from a Mr. Monrea (he didn’t identify himself beyond that—no company of job title). His response was just to repeat the name of the individual that I had already given and his re-sponse was by e-mail and nearly six months too late. So I guess that I shall have to give you the answer myself. Thomas Bugge was a Danish Astronomer during the later part of the 18th Century. His avocation was writing scientific articles slanted for popular con-sumption. His writings were translated into many languages and were widely read by the intelligent-sia and gentry of Europe. You might say that he was the “Isaac Asimov of his day”. In 1798 he was the Danish representative to the first international conference on weights and measures, a body that was called to codify the new Metric System that

had been introduced by the French Revolutionists who otherwise spent most of their time chopping off the heads of the French nobility. Since most of Europe was governed by other nobility, the Metric System was finding little favor among those other nations of that continent—the stigma of the French Revolutionist’s head chopping was attached. Bugge and the rest of the members of the Confer-ence, all scientists of note in their own right, did a Herculean task of straightening out the errors and discrepancies of the System as proposed and mak-ing it acceptable and workable. It should be noted that Bugge was not totally in favor of all aspects and was successful in having them deprecated. These factors were the attempts to decimalize time and angular measurements. As an astronomer he could see the impossible task of re-computing the vast quantities of astronomical and navigational data that had been compiled up to that time.

(That is why world wide today we are still using a sexagesimal system rather than a decimal sys-tem for time keeping, navigation, and angular measurements. Even with our modern com-puter capacities such a conversion task would be overwhelming.)

But he did write glowingly of the advantages of the Metric System in his widely read articles, thus sof-tening the attitudes of the rulers and gentry of those various other European nations. France formally adopted the System in 1799 and, thanks to Bugge, the rest of Europe followed in rapid succession.

Now let us get down to the business we are charted to do—discussing Metrology Education. Carol Singer, the Publisher/Editor of the CAL-LAB magazine is an old and dear friend of long stand-ing, we seldom disagree except on details. In her current issue, she published an editorial entitled “The Future of Metrology”. Her theme might have been taken from a statement that I copied di-rectly from an NIST e-mail and presented to you in Column 49 — “We must somehow provided for the academic education of a new generation of Professional Metrologists!”. In her editorial she bemoaned the fact that we are not training (or edu-


MQD Page 10


cating) enough Metrologists or even enough tech-nicians to fill today’s needs much less the needs of the future. She lauded the attempt made by another organization to help remedy the situation by build-ing a fund for scholarships “and to support their efforts to reach into the schools and make them aware of Metrology as a career”.

I dislike being placed in the position of “wet blan-ket” or ‘Devil’s Advocate’. But why grant those kids scholarships when there is no place for them to go to study Metrology and little or no market for them should they somehow attain such training? All the academic efforts we have been working on for the past two decades have withered except Herb O’Neal’s sub-academic vocational program at Ridgewater. There is not much point in trying to convince the school administrations of the advis-ability of instituting Metrology programs unless they can see a market for that kind of a product.

As I have explained in earlier columns, a school, any school from a kindergarten to a university, can be compared business wise to a factory. A factory processes raw material into products for which there is a market. The demands of that market de-termine the nature of the product produced. If there is no demand if the demand diminishes for a par-ticular product, the factory management then has it produce a different product. A school is no differ-ent; it processes a raw product; the student. For the kindergarten and elementary school, the customer is the parent. The parental demands exercised through pressure on local school boards and by lobbing of state legislators can and do shape the processing applied to the student during this devel-opmental phase. The high schools on the other hand have two classes of customer; the colleges and universities on the one hand and the local labor market on the other. For the former they must pro-duce a semi-processed product ready for more ad-vanced conditioning. For the latter, a finished prod-uct is required to meet the demands of that local labor market.

The colleges and universities must take partially processed product of the high school and finish process it into something that fits the demands of the managements of industry, of business, of scien-

tific research, and of educational institutions. These are the final customers of the products on any col-lege level educational program. It is with these cus-tomers, the managements, where we must start de-veloping the demand for competent fully trained Metrologists. When the management of industry starts demanding degreed Metrologists, then and only then will the management of the universities be forced to respond, for there is their market and if they do not respond, they could be soon out of business themselves.

It seems that this all boils down to the fact that we must find a way to convince management of the value of having a properly constituted Metrology organization headed by a fully qualified Metrolo-gist. How can we do this? I am really not sure. Any suggestions? Remember that most of the people who must be convinced are probably products of business schools. If I dared to express my opinion of many of those institutions based upon caliber of their product that I have encountered during my professional career, I might have a multitude of slander and liable suits filed against me.

So I am wide open for suggestions; good practical (and most important workable) suggestions of how we, the practicing professional Metrologists, can convince industrial management of the necessity of installing proficient Metrology facilities and hiring only fully qualified adroit Metrologists to oversee these Metrology functions. Please send your sug-gestions directly to me, in writing and fully identi-fied in order that I may give you full credit in this column.

Shall we try for another Metrological history ques-tion—with a monetary prize for the first best an-swer(s)? The prize will be the same $100 USD note that I offered in Column 48 and is yet unclaimed. Here are my questions, all inter-related: • What was the full name of the individual who

invented the first sealed glass thermometer? • In what year did this person invent the device? • Precisely where was this person when they in-

vented the device? • Why was that person in that location at that

time?



MQD Page 11


Now don’t try to tell me that it was Daniel Fahren-heit, René-Antoine Rèaumur, or Anders Celsius. These worthy individuals all provided improve-ments to and more practical scales for the device invented by our gentleman of interest. Another clue: I use the term “gentleman” knowingly as he was a respected member of the nobility of his na-tion. 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.

Meanwhile, as I have said half a hundred times before, “You can reach me at:

PHIL PAINCHAUD 1110 WEST DOROTHY DRIVE BREA, CA 92821-2017 PHONE: 1-714-529-6604 FAX: 1-714-529-1109 e-MAIL: [email protected] or [email protected]


To find out more visit: www.Bucherview‐Metrology.com

your calibration program ‐ Gave you consistently accurate results? Met ISO standards or FDA requirements? Had a traceability paper‐trail? Tracked out‐of‐tolerance conditions? Had a paperless record system? Was proactive instead of reactive?

The solution… a Quality Calibration Systema Quality Calibration System

Jay L. Bucher, ASQ CCT (608) 846‐6968

In-house calibration programs for biotech and pharmaceutical companies, meeting all

ISO standards and QSR requirements.

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 [email protected] 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: [email protected] Web: www.A2LA.org

MQD Page 14


AB Liaison Report IAS: IAS participated in the development of the person-nel certification development for certification of Assessors for ISO/IEC 17025. The Scheme has been developed by RABQSA in liaison with the Mexican accreditation body Entitad Mexicana de Acreditacion (EMA), the Canadian Association of Environmental Analytical Laboratories (CAEAL), the Institute for National Measurement Standards National Research Council of Canada and the American-based International Accreditation Ser-vice (IAS). The National Cooperation for Laboratory Accredi-tation (NACLA) honored IAS Vice President Pat-rick McCullen with a special service award for a decade of service working toward establishing a national laboratory accreditation system. NACLA, a not-for-profit corporation established in 1998 by public and private-sector organization representa-tives, provides coordination and focus for labora-tory accreditation programs in the United States. IAS, one of the founding members of NACLA, continues to maintain NACLA recognition. As a past member of the NACLA Board of Directors, McCullen was instrumental in defining the organi-zation’s mission to accredit U.S. laboratory ac-creditation bodies. IAS hosted Roslan Alias, Assistant Director, Ac-creditation Division, Department of Standards Ma-laysia (DSM), Ministry of Science, Technology and Innovation, Government of Malaysia on at-tachment training. During his visit, Roslan studied the U.S. inspection agency accreditation process, and received training on the infrastructure require-ments needed to operate an accreditation program under ISO/IEC Standard 17020 requirements. IAS Director of Accreditations Raj Nathan defined the many processes and policies governing the IAS inspection body accreditation program, and walked Alias through the IAS system. Alias also accompa-nied IAS Accreditation Officer Sandi McCracken and Dave Palfini of Testing Engineers, Inc., to ob-serve the steel fabrication inspection process in Utah. Alias also accompanied IAS Accreditation Officer Hershal Brewer and an inspector from SGS US Testing Co., to an inspection of wood-based

products in Oregon. IAS Vice President Patrick McCullen participated in a joint evaluation of the National Association of Testing Authorities, Australia (NATA) for the Asia Pacific Laboratory Accreditation Cooperation (APLAC) and the European Cooperation for Ac-creditation (EA). The evaluation comprised an in-ternational team of evaluators from Canada, Tai-wan, India, Finland, Japan and the United States. IAS Accreditation Officer Hershal C. Brewer, CCT, contributed to an article Certified “Safe”? published in the June 2007 issue of Quality Digest. Brewer is quoted in the article, and provided a sig-nificant amount of supporting information to the article’s author during the interview; including in-formation that may be useful for consumers seek-ing safe products, information for manufacturers that are seeking laboratories to have products tested for safety, information on some of the many types of testing conducted, and sources for additional information. For additional information regarding IAS or IAS programs, please visit http://www.iasonline.org or e-mail [email protected] ACLASS: ACLASS is holding is annual assessor/expert fo-rum September 21 – 23, 2007 at the Cincinnati Sheraton North Hotel. The forum covers topics such as measurement uncertainty, assessing to ISO/IEC 17025, and proficiency testing. This year’s forum will also entail several presentations includ-ing a presentation with discussion regarding a cus-tomer’s perspective on accreditation. Immediately following the forum, September 24 – 26, 2007, ACLASS is holding a practical measure-ment uncertainty training class, which includes hands-on breakouts for physical/dimensional, elec-trical and testing uncertainties. Participants choose from one of the three areas requiring measurement uncertainty. To register for the class, visit w w w . a c l a s s c o r p . c o m o r e m a i l [email protected].


MQD Page 15


A2LA: Revision of the A2LA Newsletter In June 2007, the A2LA newsletter was issued in its newly revised format. A2LA Today is scheduled for publication once a quarter, which is typically March, June, September and December. Through this publication, A2LA will communicate upcom-ing activities, updates to various policies and re-quirements, as well as the outcome of any meetings attended by A2LA. The next edition is scheduled for release in September 2007. Some articles that may be of interest in the June issue are: Activities of the ILAC Arrangement Com-mittee regarding recent activities with the Interna-tional Laboratory Accreditation Cooperation and Are All National Measurement Standards Equiva-lent? written by Dr. Pedro Espina from the Bureau International des Poids et Mesures (BIPM). The latter article outlines the concept of traceability from the SI to the National Metrology Institute to Accredited Laboratories. The information detailed in this article outlines the basis for the A2LA Traceability Policy. A2LA Launches Information Technology Ac-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 [email protected].

NVLAP: N V L A P L a u n c h e s e - N e w s l e t t e r NVLAP recently launched its redesigned newslet-ter - NVLAP News - in an electronic format. The newsletter is distributed to NVLAP laboratories and assessors via e-mail, and is available on this web site at: http://www.nist.gov/nvlap. One of NVLAP's objectives for quality is to communicate frequently with customers and stakeholders to de-termine their accreditation needs and requirements. The new e-Newsletter is one means for fulfilling this objective. We are anxious to hear how you like the newsletter and whether it meets your informa-tional needs! Submitted by: Hershal C. Brewer, CCT Accreditation Officer International Accreditation Service 5360 Workman Mill Road Whittier, CA 90601 Phone: 562-699-0541 Ext 3222 Fax: 562-699-8031 Mobile: 951-326-5216 [email protected] http://www.iasonline.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 Christopher L. Grachanen

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


Chair, Nominating Chair, Program 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: [email protected], [email protected]

Chair-Elect

Craig (Woody) Niemann 1489 Pheasant Run Dr. Newark, OH 43055-8046 Voice (740) 788-5034 E-mail: [email protected]

Secretary, Certification Chair, Website Manager, NCSL International Representative

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: [email protected]

Treasurer, Publication Chair, Newsletter Editor/Publisher, Share Point Administrator

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: [email protected] or [email protected]

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: [email protected]

Joe Simmons Scholarship

Norm Belecki 7413 Mill Run Dr Derwood, MD 20855-1156 Voice (301) 869-4520 E-mail: [email protected]

Standards Committee Representative Robert M. Graham Primary AC Standards Lab Sandia National Laboratories P.O. Box 5800, M.S. 0665 Albuquerque, NM 87185-0665 Phone: (505) 845-0434 Fax: (505) 844-6096 E-mail: [email protected]

Examining Chair

Duane Allen U. S. Navy P.O. Box 5000, Code MS11 Corona, CA 92878-5000 Voice (909) 273-4783 / Fax (909) 273-4599 E-mail: [email protected]

Historian

Keela Sniadach Promega Corp. 5445 East Cheryl Parkway Madison, WI 53711 Voice (608) 298-4681 / Fax (608) 277-2516 E-mail: [email protected]

ASQ Division Administrator

Ms. Leta Thrasher Voice (800) 248-1946, x7423 E-mail: [email protected]

MEASUREMENT QUALITY DIVISION OFFICERS AND COMMITTEE CHAIRS

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)

Mr. Jun Bautista Genzyme Cambridge, MA 02142 E-mail: [email protected]

Region 2 (NJ, NY, PA) Volunteer Opportunity!

Region 3 (CT, NJ, NY)

Mr. Eduardo M. Heidelberg Pfizer Parlin, NJ 08859 E-mail: [email protected]

Region 4 (Canada)

Mr. Alexander T. C. Lau ExxonMobil Whitby, ON L1R 1R1 E-mail: [email protected]

Region 5 (DC, DE, MD, PA, VA)

Mr. Richard A. Litts Litts Quality Technologies Downington, PA 19335 E-mail: [email protected]

Region 6 (AK, CA, HI, ID, MT, OR, UT, WA, WY)

Volunteer Opportunity!

Region 7 (AZ, CA, NV, part of Mexico)

Mr. Randy D. Farmer Metrology Solutions Chula Vista, CA 91913 E-mail: [email protected]

Region 8 (OH, PA)

Dilip A. Shah E = mc3 Solutions Wadsworth, Ohio 44281-8215E-mail: [email protected], [email protected]

Region 9 (IN, KY, OH)

Mr. Ryan Fischer, ASQ CCT Laboratory Accreditation Bureau New Haven, IN 46774 E-mail: [email protected]

Region 10 (OH, MI) Volunteer Opportunity!

Region 11 (NC, SC, TN, VA) Volunteer Opportunity!

Region 12 (IL, MN, ND, SD, WI)

Dr. Donald S. Ermer ASQ Fellow; Eugene L. Grant Medal (2001) University of Wisconsin—Madison Madison, WI 53706 E-mail: [email protected]

Region 13 (CO, IA, KS, MO, NE, SD, WY)

Volunteer Opportunity! Region 14 (AR, LA, NM, OK, TX, part of Mexico)

Mr. R. Keith Bennett TRANSCAT Kingwood, TX 77339 E-mail: [email protected]

Region 15 (AL, FL, GA, LA, MS, Puerto Rico)

Mr. E. Bryan Miller ASQ Fellow Bryan Miller Consulting Florence, AL 35633 E-mail: [email protected]

Region 25 (all other countries) Volunteer Opportunity!

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.

2007 NCSL International Workshop and Symposium

A Quality Calibration System

Speaker/Author: Jay L. Bucher Promega Corporation

5445 East Cheryl Parkway, Madison, WI 53711 Phone: (608) 277-2522 ; FAX: (608) 277-2516

Email: [email protected]

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: • 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,


the law authorized the FDA to demand evidence of safety for new drugs, issue standards for food, and conduct factory inspections.

• 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.

• 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. PART 211--CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED 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. PART 211--CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED 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:

• Source (The calibration procedure may be…prepared internally, by another agency, by the manufacturer, or by a composite of the three)

• Completeness (The procedure should contain sufficient instruction and information to enable qualified personnel to perform the calibration)

• Approval (All procedures should be approved and controlled…Evidence should be displayed on the document)

• 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:

• Performance requirements (device description, manufacture, type or model number, environmental conditions, specifications…)

• Measurement standards (generic description of measurement standards and performance requirements, accuracy ratio and/or uncertainty, and any auxiliary tools)

• Preliminary operations (any safety or handling requirements, cleaning prerequisites, reminders or operational checks)

• Calibration process (the detailed set of instructions for process verification in well-defined segments…upper and lower tolerance limits, and required further instructions)

• Calibration results (performance results data sheet or form to record the calibration data when required)

• Closing operations (any labeling, calibration safeguards, and material-removal requirements to prevent contamination of product)

• 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 • Have a unique identification number assigned to it • Identify who owns it (when appropriate) • Test equipment part or manufacturer’s number • Test equipment serial number and/or asset number if applicable • 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

• 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

• 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. 2. J. L. Bucher, Chapter 2 in The Quality Calibration Handbook: Developing and Managing a

Calibration Program, ASQ Quality Press, Milwaukee, 2007, pp. 9. 3. J. L. Bucher, Chapter 2 in The Quality Calibration Handbook: Developing and Managing a

Calibration Program, ASQ Quality Press, Milwaukee, 2007, pp. 9 - 19. 4. J. L. Bucher, Chapter 3 in The Quality Calibration Handbook: Developing and Managing a




Calibration Program, ASQ Quality Press, Milwaukee, 2007, pp. 49 - 50.