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Vol. 27 No. 2 The Newsletter of the Measurement Quality Division, American Society for Quality June 2013 L T TO R T : J AY B UCHER , H EATHER W ADE , D ILIP S HAH S EATED : P HIL P AINCHAUD
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Page 1: Vol. 27 No. 2 The Newsletter of the Measurement Quality ...asq.org/measure/2013/05/the-standard-june-2013.pdf · for serving as the CCT Exam Chair (2010-2012) by the ASQ Certification

Vol. 27 No. 2 The Newsletter of the Measurement Quality Division, American Society for Quality June 2013

LT TO RT: JAY BUCHER, HEATHER WADE, DILIP SHAH SEATED: PHIL PAINCHAUD

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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, 12 pt). Use single spacing between sentenc-es. Graphics/illustrations must be sent as a separate attachment, in jpg format. Pho-tographs of MQD activities are always welcome. Publication of articles, product 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. © 2013 ASQ, MQD. All rights reserved.

The Standard Vol 27, No. 2, June 2013

Managing Editor and Publisher Jay L. Bucher, Ph.D., ASQ-CCT 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 quali-ty 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 The Chair’s Corner ......................................................................... 3 MQD Minutes and Treasurer’s Report ........................................... 4 Photos from WCQI ......................................................................... 8 MQD Officers and Committee Chairs .......................................... 13 CCT exam program 10 year anniversary ..................................... 14 Measure For Measure Columns (2010) ........................................ 20

FROM THE DESK OF THE EDITOR/PUBLISHER/CHAIR

To continue one of the themes from the past five issues of The Standard, we are again reprinting six articles that were printed in the Measure For Measure column of Quality Progress during the year 2010. They are attached at the back of this edition of The Standard, in their original format as published in the Measure For Measure col-umn in QP. They include the bios of the authors at that time, and also advertisements from those pages. In a way, it might be thought to be a journey through time as seen through the ‘eye’ of the Measure For Measure column. I hope each of you enjoys it as much as I have put-ting it together. Also, we have coverage in this issue of the 2013 Measure-ment Science Conference (MSC) held in Anaheim, California, again at the Disneyland Conference Center. We also have some great pho-tos from the 2013 ASQ World Conference on Quality and Improve-ment (WCQI). Our usual column, The Learning Curve, has been de-layed due to technical problems by the author, Phil Painchaud (read that as computer failure). So, everything considered, another fine is-sue of the Measurement Quality Division’s quarterly newsletter, The Standard. On the cover, our illustrious Chair, Dilip Shah, our Chair-elect, Heather Wade, yours truly, and Phil Painchaud, all pulling booth duty during MSC 2013.

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Vol. 27, No. 2 The Newsletter of the Measurement Quality Division, American Society for Quality June 2013

The Chair’s Corner Dilip Shah, ASQ CCT, CQA, CQE

May is the month for ASQ’s World Conference on Quality and Improvement (WCQI) and it allowed us the opportunity to meet many MQD members at our booth in the exhibit hall. Thank you for stopping by and providing your feedback. It is always nice to talk with you and share knowledge. Speaking of feedback, the Voice of the Customer sur-vey e-mail went out early in May. Thank you to all who responded. For those of you who did not respond, the deadline is June 30, 2013. The link to fill out the survey is as below: https://asq.qualtrics.com/SE/?SID=SV_6D4vRAUKnI6v7OR As an added incentive, we have provided four $50 gift cards in a random drawing for those who participate in the survey. Some of the early responses to the survey call for affordable training and a division

conference. The leadership committee is planning to conduct a joint conference with the Inspec-tion Division. Our past association with Inspection Division and conducting joint conferences with them has been successful and this will not be any different. We have already secured a site to host the conference. The University of Dayton has kindly agreed to host us in September 2014. More details will follow. I had the honor of receiving my ASQ Fellow pin at the Fellows’ luncheon. It was good to see Tom Pearson at the lunch, a long time MQD supporter and an ASQ Fellow. Jay Bucher presented at WCQI with a session on Paperless Calibration Records. Jay was also recognized for serving as the CCT Exam Chair (2010-2012) by the ASQ Certification Board. Speaking of the CCT exam, it is the 10th anniversary since the first exam was administered in 2003. We thank all the volunteers who have helped with the exam in many different capacities. At the WCQI, the division was recognized for the Total Quality Award. It was one of the few divisions which had met all the criteria it had set out to qualify for the award. Following the WCQI, I participated in the NCSLI regional training event in Fort Wayne, IN where I provided a Measurement Uncertainty Workshop and conducted a round table discus-sion on the same topic. We also had successful participation at the Measurement Science Conference in Ana-heim, CA in March. Our CCT Exam refresher workshop had 6 participants and 4 took the CCT exam administered by ASQ in Anaheim, CA. Both Jay Bucher and I conducted workshops and Jay also had sessions that he participated in. Our association with the MSC goes back to the days when the MQD was chartered as a division. I also had the honor of conducting a measure-ment uncertainty workshop in Albuquerque, NM NCSLI section following the MSC. In June we will be participating with the NCSLI at the American Society for Engineer-ing Education (ASEE) conference in Atlanta, GA to promote metrology education. In July, we will be at the NCSLI conference in Nashville, TN. We are always looking for members to volunteer and bring fresh ideas. Have a great summer! Dilip

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Vol. 27, No. 2 The Newsletter of the Measurement Quality Division, American Society for Quality June 2013

The quarterly MQD teleconference call was started at 5:30 pm PDT at

Disneyland, Anaheim, CA by Dilip Shah, Chair

Also in attendance were Jay Bucher, Secretary and Heather Wade, Chair-elect.

Attending by phone: Chris Grachanen

Only one or two checks written since FY12 financial audit … all is well

Kicked an idea around to Jay about website listing all Max. J. Unis award winners … similar to NCSLI (will work on that)

Working on suggestions from Dilip after he reviewed Chris’ ASQ fellowship application (Thanks Dilip) … should be ready for final review in next week or two

A thought that came to mind, while at MSC you may want to capture some MQD member testi-monies at the booth … would make some nice value adds to The Standard

Another thought … Query ASQ headquarters for MQD membership longevity listing in order to post appreciation acknowledgements … kind of like recognizing anniversaries, another nice value adds to The Standard

Notice in Quality Progress there was a conference where I believe three or four divisions had jointly sponsored … may be an opportunity to leverage??? (with the right combination of divi-sion, we might consider doing this in the future – will look at the inputs and see where our audi-ence would fall within the proposed conference) (will also again consider working with Inspec-tion Division) Recent DAC meeting in Phoenix, AZ and DMA: Vote for the chair vote by March 31, we voted unanimously for 2 years. New item is Office of the Chair to include Chair, Chair-elect, and past Chair. Will have functional peer group. Cur-rently earning almost nothing on money market account, will vote to lend ASQ $75,000. Mo-tion and second, passed. Dilip to purchase new logoed booth, previously approved. No division awards for QMP (changing to Performance Awards and Recognition). WCQI logistics – three attending, Dilip, Jay, Heather. NCSLI – Dilip and Heather will attend and support booth duty. AIAG Quality Summit in Sep 2013 – Dilip will attend and support. MSC Fall Tutorials and STEP Conference – Dilip and Jay will attend and support if NIST sup-ports STEP, if not, they will only attend the Fall Tutorials only which we have already voted to support.

(Continued on page 5)

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Vol. 27, No. 2 The Newsletter of the Measurement Quality Division, American Society for Quality June 2013

Jay makes a motion that Dilip’s reasonable expenses for conducting his uncertainty programs during NCSLI section and region meetings be reimbursed by MQD, even dating back to the ones conducted in late 2012. Again seconded and passed, again. Elias – from his email, any way to contact CCTs to enhance division membership, etc. Dilip – asked Heather as the CCT chair if we can get a list of non-division CCT members. Ask-ing if possibly Jessie can send the email to solicit CCTs to get their ASQ membership and have MQD as their division Next meeting will be at WCQI on Monday May 6th, at 5:30 pm EDT. Motion made and seconded and passed to adjorn at 5:55 pm. Respectfully Submitted, Jay L. Bucher ASQ MQD Secretary

The quarterly MQD teleconference call was started at 5:30 pm EDT at The Marriott Hotel, during WCQI 2013, Indianapolis, IN,

by Dilip Shah, Chair. Also in attendance were Jay Bucher, Secretary and Elias Monreal, VOC chair, John Fuschino, and Sylvia Soria Attending by phone: Heather Wade, Chair-elect, We have a quorum. Chris needs to execute a loan of $75,000 from our money market account to ASQ. We can get this money back if needed at any time from ASQ. ASQ is using it to pay down their debt. Elias – So far 113 completed surveys. Last year had a total of 108 surveys returned. June 30th is the cut off date for this survey. One item that got Dilip’s attention was the economical training for our members. We plan to do a joint conference with the Inspection Division in 2014. At this time we have found a place to host us for free at the University of Dayton, Ohio, on September 18th and 19th, 2014 (Thursday and Friday). We hope to have 50 + in attendance.

(Continued from page 4)

(Continued on page 6)

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Dilip recommends getting involved in the Phil Stein lecture/symposium, more to come. Look-ing at hosting a lecture series for students. Motion and second and approved for Dilip to pursue this project. Need to consider 2014 division officers (Performance Award Recognition – PAR). Under new PAR, there is a Past Chair, Chair, and Chair-elect. Start off small – John Fuschino, Elias Mon-real will be completing his role on the Board of Directors so may take a position on MQD’s board of officers. Officer’s list must be submitted by August 9th, 2013. Heather will attend ASEE conference, representing MQD in Atlanta, GA. Joe Simmons Schol-arship winner, University of North Carolina – Liangyu He. Updates from Cert board: Considering doing recertifications through ASQ Hq. CCT in Spanish will no longer be offered. Idea that applicant applying for a division sponsored exam be given the opportunity to join the sponsoring division. Trying to figure out how to use on-line courses for getting RUs, a task force has been set up for this. Also thinking about how to handle elec-tronic media during the actual exam, instead of having to purchase hard copies of all materials for that one occasion. Jay makes a motion that after Jessie Kasberger has her baby, we send a card, or gift basket, etc., something from the division, seconded and passed. Deadline for the next edition of The Standard is May 15th. Old business – DAC in February about term limits for Chairs – no discussion at this time. New business – Sylvia: does division have a list of courses: no. However we have presented numerous courses at MSC and NCSLI. Dilip will compile a list that we have conducted and pass to Sylvia. Adjoined at 6:33 pm. Respectfully Submitted, Jay L. Bucher ASQ MQD Secretary

(Continued from page 5)

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Vol. 27, No. 2 The Newsletter of the Measurement Quality Division, American Society for Quality June 2013

MQD TREASURER’S REPORT Mar 2013

As per 31 Mar 2013 Bank Statement

MQD continues to have a strong balance sheet (Statement of Financial Position) with over $170,500.00 combined checking and saving account balances. Commercial Checking Account Ending Leger Balance as of 31 Mar 2013: $90,319.07 Money Market Saving Account Ending Balance as of 31 Mar 2013: $80,187.14 Membership Revenue for three months ending 31 Mar 2013: $7,263.00 Investment Income for three months ending 31 Mar 2013: $19.00 Royalties Income for the period from Jul to Dec 2012: $1221.00 Total revenues for all sources for three months ending 31 Mar 2013: $8,504.00 Budgeted MQD Expenses for three months ending 31 Mar 2013: $2,340.00 Respectfully Submitted, Christopher L. Grachanen ASQ MQD Treasurer

MQD TREASURER’S REPORT Apr 2013

As per 30 Apr 2013 Bank Statement

MQD continues to have a strong balance sheet (Statement of Financial Position) with over $167,700.00 combined checking and saving account balances. Commercial Checking Account Ending Leger Balance as of 30 Apr 2013: $87,565.93 Money Market Saving Account Ending Balance as of 30 Apr 2013: $80,200.50 Membership Revenue for four months ending 30 Apr 2013: $10,377.00 Investment Income for four months ending 30 Apr 2013: $26.00 Royalties Income for the period from Jul to Dec 2012: $1221.00 Total revenues for all sources for four months ending 30 Apr 2013: $11,625.00 Budgeted MQD Expenses for four months ending 30 Apr 2013: $7,939.00 Respectfully Submitted, Christopher L. Grachanen ASQ MQD Treasurer

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Vol. 27, No. 2 The Newsletter of the Measurement Quality Division, American Society for Quality June 2013

Jay Bucher, Mary Rehm, Dilip Shah.

Dilip & Jay presented Mary with an MQD Thank You Challenge Coin for all the dedication, support and hard work during the development and continuous improvements to the CCT exam pro-gram.

The Certification Board Service Award plaque Jay received as the CCT Exam Chair from 2010 through 2012.

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Vol. 27, No. 2 The Newsletter of the Measurement Quality Division, American Society for Quality June 2013

Jim Rooney, Dilip Shah, & Tom Pearson

A photo of Dilip Shah’s ASQ Fellow pin.

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Jay Bucher giving his presentation entitled: Stand-alone Paperless Records and 21 CFR Part 11. He literally had them “jumping up and down in the aisles.”

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Vol. 27, No. 2 The Newsletter of the Measurement Quality Division, American Society for Quality June 2013

Chair, Program Chair Dilip A. Shah E = mc3 Solutions 3359 Styx Hill Road, Medina, Ohio 44256-9755 Voice (330) 328-4400 E-mail: [email protected], [email protected]

Chair-Elect, Certification Chair

Heather A. Wade Calibration Officer, ASQ-CCT NSF International 789 N. Dixboro Road Ann Arbor, MI 48105 Voice (734) 913-5712 E-mail: [email protected]

Treasurer, NCSL International Representative

Christopher L. Grachanen Manager, Houston Metrology Group HP P. O. Box 692000 MS070110 Houston, TX 77269-2000 Voice (281) 518-8486 E-mail: [email protected]

Secretary, Immediate Past Chair, Publica-tions Chair, Newsletter Editor/Publisher, Website Liaison

Jay L. Bucher, Ph.D., ASQ-CCT Bucherview Metrology Services, LLC 6700 Royal View Dr. De Forest, WI 53532-2775 Voice (608) 846-6968 E-mail: [email protected]

Standards Committee Representative

Jay L. Bucher, Ph.D., ASQ-CCT Bucherview Metrology Services, LLC 6700 Royal View Dr. De Forest, WI 53532-2775 Voice (608) 846-6968 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 E-mail: [email protected]

Membership Chair, Voice of the Customer Representative

Elias Monreal Industrial Tool Die & Engineering 4765 S. Overland Dr. Tucson, AZ 85714 Voice (520) 241-0478 E-mail: [email protected]

Historian

Brandon Downing 3054 Cross Creek Dr Cumming, GA 30040 Voice (678) 983 9455 E-mail: [email protected]

Nominating Chair

Craig A. Niemann, CMSgt, USAF

Joe Simmons Scholarship Dilip A. Shah E = mc3 Solutions 3359 Styx Hill Road, Medina, Ohio 44256-9755 Voice (330) 328-4400 E-mail: [email protected], [email protected]

Community Development Administrator Jessie Kasberger ASQ 600 N. Plankinton Avenue Milwaukee, WI 53201 Voice 800-248-1946 ext 7423 E-mail: [email protected]

MEASUREMENT QUALITY DIVISION OFFICERS AND COMMITTEE CHAIRS

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CELEBRATING 10 YEARS OF METROLOGY EXCELLANCE

ASQ CERTIFIED CALIBRATION TECHNICIAN (CCT) PROGRAM

It has been the work of hundreds of individuals contributing their time; expertise and enthusiasm which has made the CCT program what it is today … a recognized benchmark of demonstrated metrological knowledge for the metrology profession. In recognition of CCT program contributors and the over 1500 worldwide CCT alumni we at MQD would like to share the following original proposal, presented to ASQ’s board of directors, signaling the start of the CCT program.

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Certified Calibration Technician

Proposal for A New Certification Program

ASQ Measurement Quality Division

BACKGROUND:

Measurement is a building block upon which most trade and industry is based. Calibration ensures the integrity ofmeasurements and is a fundamental part of the quality programs of most industries throughout the world. Calibrationis the backbone upon which the Industrial Revolution, mass production, statistical process control and eveninternational trade is based.

Almost every industry has the need to make measurements to monitor quality, regulate processes or even exchangegoods. The validity of these measurements is, to a large extent, dependent on the assumption that the equipmentused to make the measurement is operating within its intended specifications. To this end, the equipment needs to becalibrated at periodic intervals by trained technicians. Thousands of facilities have been established at military,government, industrial, academic and commercial locations to perform these needed calibrations, yet no formalprogram exists to define the body-of-knowledge or skills required for this important task. A peer recognition of aproficiency program for calibration technicians would serve all industries.

A calibration technician “tests, calibrates, maintains and repairs electrical, mechanical, electromechanical andelectronic measuring, recording and indicating instruments and equipment for conformance to establishedstandards.”1

PROPOSAL:

In 1999, the ASQ Measurement Quality Division voted to support the development of a certification program forcalibration technicians. The Council authorized the development of this proposal and its presentation to the ASQCertification Committee.

Therefore, the Measurement Quality Division proposes a new certification program for calibration technicians witha proposed title of Certified Calibration Technician (hereby referred to as proposed CCT program). To support thisproposal, the seven criteria applied to new certifications by the ASQ Certification Committee, ProfessionalDevelopment Council, and the Board of Directors has been addressed herein. An explanation follows as to how eachcriterion is satisfied for the proposed CCT program.

1. The discipline shall be a unique area of quality technology generally practiced in the quality profession.

The need for calibration has been included in the body-of-knowledge for many certification programs, includingquality technician (CQT), mechanical inspector (CMI), quality engineer (CQE) and quality manager (CQM). Due tothe broad subject matter these certification programs must encompass they cannot adequately addressed the depth ofcalibration knowledge and skill sets required by today’s calibration practitioners. While certified qualityprofessionals can perform many measurement related tasks, competent personnel dedicated to calibration performmost equipment calibrations.

The US department of Defense (DOD) has long recognized the ‘mission essential’ need for trained calibrationpersonnel. To this end DOD has, since 1960’s, routinely graduated calibration personnel from its technical schoolsto impart this specialized knowledge. The US Dept. of Commerce’s National Institute for Standards and Technology(NIST) conducts various technical courses to help industry and other governmental agencies develop the expertcalibration talent demanded by today’s technologies.

1 State of New York, Department of Labor Standards

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2. The discipline shall be generic in nature, generally applicable to the production of any product, by anyprocess, and/or to the rendering of any service.

Calibration programs are integral to most every industry and are called for in most of the quality standards in usetoday, including ISO 900X, QS-9000, ISO/TS 16949, AS-9000, and FDA GMP/QSRs. Most anythingcommercially manufactured requires measurements obtained from calibrated equipment in order to ensurespecifications and tolerances are met. This is especially true in light of today’s marketplace where technologies,shared manufacturing operations and regulatory requirements with stringent design and quality requirements areincreasing the demand for more exact measurements.

3. The discipline shall have a substantial and authoritative body of knowledge in the public domaindescribing proven principles and practices of the technology.

A partial listing of regulations, standards and commercial references applicable to calibration and metrology isincluded here. This list is intended to provide applicable examples but has not yet been determined to represent adefinitive body of knowledge for proposed CCT program.

Regulations, Standards and References Applicable to proposed CCT program(Partial listing)

FUNDAMENTAL REGULATIONS AND STANDARDS

• ISO 9001 Quality Systems – Model for Quality Assurance in Design, Development, Production, Installation andServicing, 1994

• QS-9000, revision 3, Quality System Requirements, AIAG, 1998

• ISO/TS 16949, International Automotive Quality Standard

• AS 9000, Automotive Quality Standard

• 21CFR Part 820 Quality System Regulation, FDA, 1996

• 21CFR Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals, 1996

CALIBRATION REGULATIONS AND STANDARDS

• ISO 17025 General requirements for the competence of testing and calibration laboratories, 1999

• ANSI/NCSL Z540-1-1994 Calibration Laboratories and Measuring and Test Equipment – GeneralRequirements

• ISO 10012-1 Quality assurance requirements for measuring equipment, 1992

COMMERCIALLY AVAILABLE CALIBRATION / METROLOGY REFERENCES

• Managing the Metrology System, ASQ Press, 1992• Measurement and Calibration for Quality Assurance, Prentice Hall, 1991• Uncertainty, Calibration and Probability, IOP Publishing Ltd, 1991• Fundamentals of Dimensional Metrology, Delmar Publishers, 1989• Recommended Practices (RP) 1 through 15, NCSL International, reviewed and update as necessary• Measurement and Calibration, Work Place Training, 1999• Calibration: Philosophy in Practice, Fluke Corporation, 1994• Calibration & Standards – DC to 40GHz, SS&S Inc., 1994• Precision Measurement and Calibration: Electricity, NBS Special Publication, 1985• Precision Measurement and Calibration, NBS Special Publication 300, 1969

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4. The discipline shall be consistent with ASQ objectives, policies, and procedures.

One of ASQ's strategic objectives is to be the recognized worldwide leader for advancing individual andorganizational performance excellence. The proposed CCT program clearly would help to achieve this objective.The proposed CCT program will appeal to calibration professionals by focusing on calibration specific knowledge /skills sets not adequately addressed in other quality certifications and by providing a measure by which calibrationpersonnel expertise may be assessed. This program would provide the foundation for defining the calibrationpractices many other certification programs depend upon and help drive development of learning / mentoringprograms needed to develop and sustain the body of skilled calibration personnel required throughout governmentand industry.

5. Training in the principles and practices of the technology shall be readily available on a geographicallydispersed basis.

Training in the practice and procedures is available from multiple sources. They can be arranged into the followingcategories:

Factory/Vendor – Provided by equipment vendors on the use, calibration and maintenance of their equipmentAcademic – Formal degree or certificate programs at educational institutionsConsultants or Training Organizations – Training provided by consultant or training organizations in this fieldOrganizational – Training conducted by organizations dedicated to calibration, such as NCSL International or the

Measurement Quality Division (MQD) of ASQSelf-paced programs – textbooks, video and interactive CR-ROM training

Here is a small sampling of current, relevant training available:

Type Source Location TopicsSelf-paced WP Training CD-ROM Intro to metrology, dimensional, electrical,

pressure, temperature, force, mass, uncertaintyMIT Video Video Series on Measurement

Academic Butler County CC Butler, PA AAS Metrology

California StateUniversity

Carson, CA MSQA, Metrology Courses

CC of Aurora - HEAT Aurora, CO AAS; Metrology and Advanced PrecisionMeasurement

Ridgewater College Hutchinson, MN Certificate, AAS Metrology

Madison Area TechnicalCollege

Madison, WI Machine Tool Technology, Dimensional Classes

McComb CountyCommunity College

Warren, MI Dimensional QA, AAS, Certificate

Monroe County CC Monroe, MI AAS in Metrology Technology

Ohio State University Columbus, OH Coordinate Metrology & MeasurementLaboratory classes

Piedmont TechnicalCollege

Greenwood, SC Instrumentation Technology ElectronicEngineering Technology

Rock Valley CollegeTechnology Center

Rockford, IL Certificate Program

Sinclair CommunityCollege

Dayton, Ohio QA Tech, AAS Certificate, QE Tech,Dimensional Classes

Tidewater Community Norfolk, VA Certificates in Quality Assurance and

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College Metrology, AAS Industrial Quality AssuranceYuba College Marysville, CA AAS, Measurement Science/Technology

Factory Mitutoyo, Hart Scientific,Agilent, DH Instruments,General Sciences, FlukeCorp., MKS Instruments,Digital MetrologySolutions, Ruska,Instrument Corp., micro-University, Tektronix, etc.

At factory orremote locations

Use, calibration and repair of vendor suppliedmeasurement equipment

Consultants orTrainingOrganizations

Coast MetrologyHN ConsultantsIntegrated Sciences GroupExcel PartnershipEquip. ReliabilityInstituteScience & Eng. Assoc.Tustin Technical Institute

Availablenationwide

Specific training offered in various areas ofmetrology and/or metrology managementsystems

Organizational NCSL International,A2LA, ASQ-MQD,NIST, ILAC, MSC

Seminars andclasses offered atconferences andmeetings

Specific training offered in various areas ofmetrology

6. The area of technology shall have the commitment and active support of one or more ASQ Divisions orTechnical Committees with the capacity of providing adequate testing criteria for proficiency in thetechnology.

The ASQ Measurement Quality Division has a long history of commitment to its members in the metrologycommunity, including government, private enterprise, and educational institutions. The proposed CCT program isconsistent with the objectives of ASQ and ASQ Measurement Quality Division as well as their policies andprocedures. The Division Council believes the proposed CCT program would be of significant benefit to itsmembers as well as industry at large. The Division Council is committed to supporting the proposed CCT program(body of knowledge development, test criteria formulation / validation, cut-score process activities, etc.) via itsleadership and subject matter experts derived from among its 5000+ members.

7. There must be a definable and continuing market and a justified need on a broad geographic basis forcertification.

The need for competent calibration professionals and therefore this certification program, has been highlighted byrecent events:

• Inclusion in QS-9000, Automotive Quality Standard, Rev. 3 in 1998 for the use of accredited commercialcalibration facilities. Trained calibration technicians are needed to obtain accreditation.

• The issuance of ISO 17025 (ISO Standard), General requirements for the competence of testing and calibrationlaboratories, in December 1999 replacing ISO/IEC Guide 25, (ISO Guide of same title).

• Issuance of ISO/TS 16949, International Automotive Quality Standard, which requires calibration to beperformed in accordance with ISO 17025.

• Early drafts of ISO/CD 9000:2000 requiring the use of accredited calibration vendors (subsequently eliminatedfrom the DIS standard). The need was identified, despite its elimination from future drafts.

• The recent surge in bodies offering accreditation and registration services for calibration laboratories (L-A-B,BVQi, NQA-USA, etc.)

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Page 5 of 5

The marketplace for calibration is estimated to be $1.5B annually 1 within the commercial sector of the United Statesand over $3.5B worldwide and will grow as the economy expands and the implementation of quality standardsspreads further.

Our global economy has resulted in hundreds of calibration laboratories throughout the world becoming accreditedwith many soon to follow in order to have their calibrations recognized outside the realm of their country’s legalMetrology systems, comply with industry quality standards and meet market demands. Key to granting a laboratoryaccreditation status is the satisfactory assessment of laboratory personnel qualifications congruent with thecalibration activities they are engaged in. USA laboratory accreditation program representatives (NVLAP andA2LA) are active committee members on the proposed CCT program.

Many Department of Defense (DOD), Department of Energy (DOE) and National Aeronautics and SpaceAdministration (NASA) calibration laboratories are under multimillion dollar, multiyear contacts, staffed by civiliancalibration practitioners with the trend for subcontracting more of these calibration services on the rise. Accessingcalibration practitioner competence, congruent with assigned duties, is critical in helping assure contractualcommitments are satisfactory met. Governmental agency representatives (DOD, DOE, NASA) are active committeemembers on the proposed CCT program.

SUMMARY:

Almost every industry, quality professionals included, would greatly benefit from the proposed CCT program.Measurement, and therefore calibration, is a vital tool to most every quality effort and a part of most every qualitystandard. The need for competent calibration practitioners is geographically and industry-diverse and will grow asformal adoption of quality standards grows and traditional sources of qualified personnel shrink. This role representsa unique area of quality technology largely defined by a publicly available body of knowledge and supported bywidely available professional development resources. The proposed CCT program is consistent with the objectivesof ASQ and ASQ Measurement Quality Division as well as their policies and procedures. Therefore, the ASQMeasurement Quality Division supports this proposal and, if accepted, will commit the necessary development andmaintenance resources.

Respectfully submitted,

Christopher GrachanenChairmanProposed CCT Program Committee

1 Commercial Market Study, 1999. In-house providers $900M (self-maintainers); OEM's $320M (i.e. HP/Agilent,Fluke, etc.); Third-party providers $280M (i.e. GE, Essco, GTE, Bell, etc.). Total Estimated Calibration Market$1500M

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Measure For Measure BY JaY L. Bucher

What really CountsKeep the focus on quality, not competitors, to ensure success

Upon reflection, it seems that my 20

years spent overseas while serving in the

U.S. Air Force resulted in me missing the

moment when commercials and advertis-

ing changed—and not for the better.

In my days growing up on a dairy farm

in Minnesota, when a product was adver-

tised on television or in the newspaper,

the ad expounded on the attributes of the

product and what it would do to make

your life better, safer or more productive.

Today, most ads tell us how much better

a particular product is than their competi-

tion, usually by pointing out a bad or nega-

tive aspect of the competitor’s offering.

For example, one car company talks

about how many more miles per gallon

a certain make or model will get than

Toyota or Honda. It doesn’t tell us how

well the car or truck handles a curvy road

or the quality of the interior. It doesn’t say

how many or what generation of air bags

are available or if the seats are heated for

those of us in the northern states (that can

make all the difference during the ride to

work on a cold Wisconsin morning).

Moving forwardBut while we may have taken a few steps

backward in some respects, we haven’t

veered completely off the road. I hope you

still have quality systems in place at your

organization. None of that should have

changed because of the recent economic

upheaval.

We still try to produce the best quality

products at the lowest cost, don’t we? Af-

ter all, we still compete against the same

competition we had one or two years

ago, unless of course they have gone out

of business. Even in that case, it’s likely

another company has entered the fray.

We got where we are because today, like

yesterday, the product with the best qual-

ity at the lowest price is still going to be

the one purchased by the knowledgeable

consumer.

The old saying, “You can fool all the

people some of the time and some of the

people all of the time, but you cannot fool

all the people all the time,” applies now

more than ever. People are not stupid, and

we are tired of companies trying to fool

us. By sifting through the misdirection

of the advertisers and blowing away the

smoke, we can get to the truth and mea-

sure what really counts at work, at home

and in our communities.

Attitude is everythingWe can start by measuring our attitudes.

But there is usually a positive and negative

connotation to everything. We’ve all heard

of the glass being either half full or half

empty. Which one you see is an indication

of whether you have a positive or negative

attitude.

Is it important to consider how you

come across to your peers, supervisor or

upper management? Does it make any dif-

ference in the final outcome of a decision

or process? Or is the final decision going

to be made based on facts and data, not on

how a person is perceived or evaluated by

their outlook or attitude?

Something to consider: If attitude were

not part of the mix, then you shouldn’t

need to sell your ideas or suggestions. The

facts and data should stand on their own,

making the outcome a foregone conclu-

sion. But such is not the case in the world

of sales, marketing, new product devel-

opment or any of the thousands of other

business decisions discussed on a daily

basis. The pitch person must have a posi-

tive attitude about the idea or product, or

it’s dead in the water from the start.

The same can be said about your

quality program. Are you selling ISO on

a daily basis? Do you wholeheartedly

support the code of federal regulations?

Or do you only mouth the words and slam

the processes to your coworkers and

subordinates behind management’s back?

Do you walk the talk? Is your program

based on the fact that a quality system, no

matter if it is voluntary or mandated, is the

foundation for supplying a quality product

to your customers on a daily basis?

How do you measure what really

counts? By the attitude of your cowork-

ers Monday morning or by how fast they

run out the door Friday afternoon? By

quarterly production numbers or yearly

retention rates? Is loyalty a part of the

equation or an unknown quantity that has

never been considered?

Measuring what really counts—at

work and at home—isn’t easy. There is

no simple formula. It comes through trial

and error, time and experience, success

and failure. Hopefully, we all learn from

our mistakes. We usually get many tries

to make the right decisions and work out

the bugs. Let’s hope that in the current

environment—especially because of the

current environment—we get it right

sooner than later. Here’s hoping all of you

measure what really counts. QP

Jay L. Bucher is president of Bucher-view Metrology Services in De Forest, WI. he is editor and coauthor of The Metrology handbook and author of The Quality calibration handbook, Paperless records and ethics—The Final Frontier. he is a senior member of aSQ, the chair of the Measurement

Quality Division and a certified calibration technician.

January 2010 • QP 51

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QP • www.qualityprogress.com52

Measure For Measure BY JAY L. Bucher

Out of SyncIf we’re not on the same page, quality efforts go down the drain

Because of deadlines and other time

commitments, I’m writing this while Santa

is still 10 days away from his yearly trip,

so I have the privilege of looking to the fu-

ture from the past. It’s kind of like looking

out the windshield of your car while still

being able to glance in the rearview mirror

and see what is behind you.

During the holidays, when children

everywhere wonder whether they’ll have

presents or coal waiting for them on

Christmas morning, my thoughts always

turn to the concept of good and bad—or,

more broadly, to the idea of perception.

President Barack Obama has been in

office for a little more than a year, and

much of that time has been spent hag-

gling over his job performance. As might

be expected, half of the country thinks

he’s doing a fine job, while the other half

couldn’t disagree more.

Different viewpointsThe same discord occurs among U.S. leg-

islators, who are occupied by the dilemma

of the U.S. healthcare bill. I’m amazed how

two people (or political parties) can read

the same piece of legislation and form

entirely different opinions about what it

means.

Then, I realized the same conundrum

happens daily in the world of quality.

Two people look at the same standard

or regulation and read into it different

things. Does this come from their educa-

tion, background, training or the type of

car they drive? No matter the cause, the

effect is usually the same—an observa-

tion, write-up or Form 483 from the FDA

is generated, justified or not, and some-

body needs to answer why and how it is

going to be fixed.

Based on my experiences in the world

of measurement (remember that metrolo-

gy is the science of measurement), one of

the reasons this happens is because either

the personnel in charge of the calibration

department or the inspector (auditor)

doesn’t understand the definition of two

basic words—calibration and traceability.

Clearing up calibrationDuring my first audit as a civilian after

an extended military career, I was told

that mercury thermometers (as opposed

to electronic thermometers) could not

be calibrated because they could not be

adjusted.

After picking my jaw off the table, I

very courteously informed the auditor she

was mistaken and tried to explain the real

meaning of calibration—the comparison

of two measurement devices or systems,

one of known uncertainty (your standard)

and one of unknown uncertainty (your test

equipment). The ability to adjust, align or

repair has absolutely nothing to do it.

I showed her a couple references and

provided examples. She took a few notes

and thanked me for correcting a long-

held belief, and my calibration program

received a laudable commendation during

the out-briefing.

At the time, the quality manager and di-

vision vice president were having simulat-

ed coronaries because I dared to question

an auditor; but they were quick to recover

when they realized they also did not know

the correct meaning of calibration.

Before I continue, I should point out

that it’s never a good idea to argue with an

auditor or inspector. In this case, I was not

arguing with her; I was helping to educate

her on a topic about which she was mis-

taken, thereby helping to make her a more

informed auditor. She thanked me for

helping her, and I appreciated that.

I’m not advocating similar actions

every time you disagree with an inspec-

tor or auditor—quite the contrary. You

must have all your references lined up and

just cause to challenge them. That’s why

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March 2010 • QP 53

you have rebuttals and negotiations to go

along with written responses.

History lessonGetting back to calibration, at the time

of my discussion with the auditor, my

thoughts turned to how the definition of

calibration was not something I made up

at the spur of the moment. In fact, it has

been around for at least 5,000 years. The

National Conference of Standards Labo-

ratories International offers the following

example, which validates calibration.1

One of the earliest records of precise

measurement comes from the Egyptians,

who studied geometry to assist them in the

construction of the pyramids. It is believed

that in about 3000 B.C., the Egyptian unit

of length came into being. The Royal Egyp-

tian Cubit was decreed to be equal to the

length of the forearm from the bent elbow

to the tip of the extended middle finger

plus the width of the palm of the hand of

the pharaoh or king ruling at that time.

The Royal Cubit Master was carved

out of a block of granite to endure for all

times. Workers building tombs, temples

and pyramids were supplied with cubits

made of wood or granite. The royal

architect or foreman of the construc-

tion site was responsible for maintaining

and transferring the unit of length to the

instruments used by workers, who were

required to bring back their cubit sticks

at each full moon to be compared to the

Royal Cubit Master. Failure to do so was

punishable by death.

Though the punishment prescribed

was severe, the Egyptians inadvertently

had anticipated the spirit of the present

day system of legal metrology, standards,

traceability and calibration recall. With this

standardization and uniformity of length,

the Egyptians achieved surprising accura-

cy. Thousands of workers were engaged in

building the Great Pyramid of Giza, which

was constructed to stand roughly 756 feet.

Through the use of cubit sticks, they were

within 4-1/2 inches—an accuracy of 0.05%.

Trace amountsThere is one other part of this equation—

traceability. According to ISO/IEC Guide

99:2007, traceability is the property of a

measurement result whereby the result

can be related to a reference through a

documented unbroken chain of calibra-

tions, each contributing to the measure-

ment uncertainty.

The note at the end of the definition

for metrological traceability defines the

expression “traceability to the SI (Interna-

tional System of Units)” as “metrological

traceability to a measurement unit of the

International System of Units.”2

The SI is based on the International

System of Quantities. Along with rules for

its use, the SI was adopted by the General

Conference on Weights and Measures.

Test equipment calibration is not traceable

to the U.S. National Institute of Standards

and Technology (NIST), but to the SI

through NIST. All calibration certificates

and records should have a statement that

declares their calibration is traceable to

the SI (if, in fact, their calibration is trace-

able either through third-party calibration

labs or NIST).

Some of you may remember an old

English proverb: For want of a nail the

shoe was lost; for want of a shoe the horse

was lost; for want of a horse the rider was

lost; for want of a rider the battle was lost;

for want of a battle the kingdom was lost;

and all for the want of a horseshoe nail.

The same could be said of a traceability

statement—without it, there is no proof

calibration took place. If the calibration

of your test instrument is not traceable to

the SI, then true calibration has not been

accomplished, and you might as well pre-

pare yourself for the inevitable observa-

tion, write-up or Form 483.

Here’s hoping all of you are on the same

page when it comes to traceable calibration

in your quality systems, and that our legisla-

tors consider basing decisions on objective

data with traceability to solid facts. QP

RefeRences1. Stuart Kleven, Israel Vasquez and David Atkins, “calibration for

Nondestructive Testing,” http://www.asnt.org/publications/materialseval/basics/oct06basics/oct06basics.htm.

2. International Organization for Standardization, ISO/IEC Guide 99:2007—International vocabulary of metrology—Basic and general concepts and associated terms (VIM), 2007.

I’m amazed how two people can read the same thing and form entirely different opinions about what it means.

Jay L. BuChEr is president of Bucher-view Metrology Services in De Forest, WI. he is editor and coauthor of The Metrology handbook and author of The Quality calibration handbook, Paperless records and ethics—The Final Frontier. he is a senior member of aSQ, the chair of the Measurement

Quality Division and a certified calibration technician.

BucheR’s ViewsAs a Measure for Measure columnist, Jay L. Bucher has shared his thoughts on everything from the value of honesty to how calibration affects us from birth to death. To see what he had to say, log on to www.qualityprogress.com.

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QP • www.qualityprogress.com48

Measure For Measure BY Dilip Shah

supplier DemandHow to select a test and calibration partner

If an organIzatIon is registered to

ISO 9001 or accredited to ISO 17025, it

needs to ensure the inspection, measure-

ment and test equipment (IMTE) it sends

out for calibration has measurement

(metrological) traceability.1 It also needs

to evaluate its calibration supplier. The

following requirements from the stan-

dards should receive special attention:

1. ISO9001:2008,clause7.4.1: “The

organization shall evaluate and select

suppliers based on their ability to sup-

ply product in accordance with the or-

ganization’s requirements. Criteria for

selection, evaluation and reevaluation

shall be established. Records of the

results of evaluations and any neces-

sary actions arising from the evaluation

shall be maintained.”

2. ISO17025:2005,clause4.6.4: “The

laboratory shall evaluate suppliers

of critical consumables, supplies and

services which affect the quality of test-

ing and calibration, and shall maintain

records of these evaluations and list

those approved.”

3. ISO9001:2008,clause7.6(a):

“Where necessary to ensure valid

results, measuring equipment shall be

calibrated or verified, or both, at speci-

fied intervals, or prior to use, against

measurement standards traceable to

international or national measurement

standards; where no such standards

exist, the basis used for calibration

or verification shall be recorded (see

4.2.4).”

4. ISO17025:2005,clause5.6.2.1.1:

“For calibration laboratories, the

program for calibration of equipment

shall be designed and operated so as to

ensure that calibrations and measure-

ments made by the laboratory are

traceable to the International System of

Units (SI).

a) “Note 1: Calibration laboratories

fulfilling the requirements of this

international standard are consid-

ered to be competent. A calibration

certificate bearing an accreditation

body logo from a calibration labora-

tory accredited to this interna-

tional standard, for the calibration

concerned, is sufficient evidence of

traceability of the calibration data

reported.”

Body of workIf the customer is using an ISO 17025-ac-

credited laboratory, the requirement for

measurement (metrological) traceability

is satisfied if the parameter and range cali-

brated by the laboratory is under its scope

of accreditation (SoA).

It is useful, however, if the labora-

tory has been accredited by an accredit-

ing body that is recognized under the

International Laboratory Accreditation

Cooperation Mutual Recognition Arrange-

ment (ILAC MRA), which is illustrated in

Figure 1.

The diagram shows the six ILAC MRA

accrediting bodies in the United States.

They are:

• ACLASS Corp. (www.aclasscorp.com).

• American Association for Laboratory

Accreditation (A2LA, www.a2la.org).

• International Accreditation Services

(IAS, www.iasonline.org).

• Laboratory Accreditation Bureau (L-A-B,

www.l-a-b.com).

• The National Voluntary Laboratory

Accreditation Program (NVLAP, http://

ts.nist.gov/standards/accreditation/index.

cfm).

• Perry Johnson Laboratory Accredita-

tion (PJLA, www.pjlabs.com).

Under the ILAC MRA, any of the ac-

crediting bodies evaluated by one of the

regional cooperations is recognized by

the other accrediting bodies evaluated by

another regional cooperation. The regional

cooperations conduct periodic peer evalua-

tion assessments of the accrediting bodies

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May 2010 • QP 49

in accordance with ISO 17011 standard

before they are granted ILAC MRA status.

The websites of the accrediting bodies

list all the laboratories they accredit. This

includes laboratories in good standing,

suspended, voluntarily withdrawn and

making false claims of accreditation. This

makes the websites good places to start

the laboratory evaluation process.

The websites also maintain the SoA for

each laboratory’s capability (parameter,

range, calibration and measurement capa-

bility) and note when the SoA expires. An

example is shown in Table 1 (p. 50), with a

few sample measurement parameters.

Recognized accrediting bodies from

other countries can be accessed by visit-

ing the regional laboratory cooperation

websites shown in Figure 1.

Sending calibration and testing work

to an accredited laboratory satisfies the

requirement for measurement traceability

in ISO 9001 and ISO 17025 (Nos. 3 and 4

in the previous list). Before committing to

send calibration or test work to a labora-

tory, however, be sure to study the labora-

tory’s SoA to ensure its best measurement

capability (uncertainty) is considerably

less than the artifact that is being sent for

calibration.

A typical ratio used in the industry is

4:1, known as the test uncertainty ratio.

For example, you don’t want to send your

laser micrometer (uncertainty measured

in nanometers) to a laboratory whose best

measurement capability is achieved by use

of a steel meter ruler (uncertainty of less

than a millimeter).

Nos. 1 and 2 in the previous list ask

for evaluation and selection criteria.

These can be satisfied by documenting the

requirement that only accredited labora-

tories shall be used for calibration and

testing work. In addition, the organization

should download the individual supplier

laboratory’s SoA from the accrediting

body’s website and file it as a record for

evaluation.

The SoA also has an expiration date,

which should be used as a base target for

periodic reevaluation (normally every two

years). It should be noted that accredited

laboratories revise their SoA between

evaluations. It may be a good idea to re-

view the SoA from the accrediting body’s

website before sending any equipment for

test or calibration. Many organizations

International LaboratoryAccreditation Cooperation

(ILAC)

South AfricanDevelopmentCommunity

Accreditation (SADCA)

European Cooperationfor Accreditation (EA)*

InterAmericanAccreditation

Cooperation (IAAC)*

Recognizedaccrediting bodies

(See www.european-accreditation.org fora list of laboratories)

Recognizedaccrediting bodies

(see www.aplac.org fora list of laboratories)

Recognizedaccrediting bodies

(see www.iaac.org.mxfor a list of laboratories)

A2LA, ACLASS, IAS, L-A-B, NVLAP, PJLA

A2LA, ACLASS,NVLAP

Asia Pacific LaboratoryCooperation (APLAC)*

www.sadca.org

International Laboratory accreditation Cooperation Mutual recognition arrangement / Figure 1

*solid lines represent those recognized regional Cooperation Bodies whose regional Mutual recognition arrangements (Mra/MLa) have been successfully peer evaluated by iLaC.

a2La = american association for Laboratory accreditationaCLass = aCLass Corp.isa = international accreditation servicesL-a-B = Laboratory accreditation BureauNVLaP = National Voluntary Laboratory accreditation ProgramPJLa = Perry Johnson Laboratory accreditation

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QP • www.qualityprogress.com50 QP • www.qualityprogress.com

Measure For Measure

maintain supplier selection, approval and

review activity in a spreadsheet with ac-

tive links to SoA (see Table 2).

Speak the languageWhen requesting traceable calibration ser-

vice, equivalent language should always

be in the calibration purchase orders to

protect the interest of the customer:

1. ISO 17025 accredited calibration with

“actual as found,” “as left” and “mea-

surement uncertainty” is required on

all calibration certificates. This satisfies

measurement (metrological) traceabil-

ity requirements and provides history

and performance of the equipment.

2. If a specific method or equipment for

test and calibration is desired, it should

be specified (for example, manufac-

turer’s recommended method, industry

standard ASTM method XXXX, tensile

tester XYZ, multifunctional calibrator

model ABCD or using triple point of

water cell).

3. Blanket statements of compliance and

statements of measurement uncertainty

shall not be accepted because they do

not provide any information except for

pass/fail. But, pass/fail also needs to be

compared with the criteria.

4. Accredited laboratory shall be accred-

ited by an accrediting body under an

ILAC MRA. In a global economy, this

provides for international recognition of

test and calibration data, and confi-

dence in the integrity of data.

5. If required, the calibration interval for

the equipment should also be included.

ISO 17025-accredited laboratories

should not recommend a calibration

interval in a report unless specified

by the customer or superseded by a

legal or regulatory requirement. The

customer knows the end use of the

equipment best and should determine

the calibration interval based on use

and experience.

Any purchasing document (for example,

a purchase order or requisition) for test

and calibration service should be techni-

cally reviewed before releasing it to the

calibration or test supplier. The record of

this technical review should be maintained.

This may be documented on the copy of

the purchase document.

Upon receipt of the calibration and

test item, another documented technical

review should be performed to ensure the

customer received what it specified on the

purchase document and that all contrac-

tual requirements were met.

The measurement uncertainty data

requirement and using the accredited

laboratory satisfies the requirement for

measurement traceability as defined in

ISO guide 99:2007.2

The topic of evaluating and qualifying

an unaccredited laboratory as a test and

calibration supplier shall be discussed in a

future column. QP

referenCes and note1. For more on this topic, see Dilip Shah, “in No Uncertain

Terms,” Quality Progress, January 2009, pp. 52-53.2. ibid.

BIBLIographyISO/IEC Guide 99:2007, International vocabulary of metrol-

ogy—Basic and general concepts and associated terms.ISO/IEC 17025:2005, General requirements for the compe-

tence of testing and calibration laboratories.ISO/IEC 9001:2008, Quality management systems—Require-

ments.

DIlIP Shah is president of E = mc3 Solutions in Medina, Oh. he has more than 30 years of experience in metrology and applications of quality and statistics in metrology. he is a past chair of aSQ’s Measurement Quality Division and akron-Canton Section 0810, and is co-author of The

Metrology handbook (aSQ Quality Press, 2004). Shah is an aSQ-certified quality engineer and calibration technician, and a senior member of aSQ.

Parameter/equipment Range Best uncertainty

(CMC) Comments

Micrometers up to 19 in (65 + 8.0L) μin.gage blocks L in inches

DC voltage—generate

(0 to 330) mV

(0.33 to 3.3) V

(3.3 to 33) V

(33 to 330) V

(330 to 1000) V

16 µV/V+ 1 µV

8.8 µV/V + 2 µV

10 µV/V + 20 µV

14 µV/V + 0.15 mV

15 µV/V + 1.5 mV

Multifunction calibrator

Test: durometer hardness—rubber

Test method:

asTM D2240

(Types a and D)

sample scope of accreditation / TaBLe 1

Supplier Accredited by Scope link*Scope

expiration date

Address Telephone number Date of review Approval

status

Calibrations r us

aB accreditations

www.aB.org/scope123.pdf

12/31/10 123 any street (123) 456-7890 01/15/10 approved

sample spreadsheet for selecting, approving and monitoring calibration and test suppliers / TaBLe 2

*Note: The scope link urL is an example and does not exist.

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QP • www.qualityprogress.com54

Measure For Measure BY Stephen DotY anD Del CalDwell

Well equippedEffective hardware management can boost your bottom line

Are your customers dissatisfied with

your products due to marginal perfor-

mance or interoperability problems?

Are you experiencing schedule delays,

callbacks or degradation of services you

provide? Are you noticing an increase in

warranty returns and test failures that

result in decreased margins and increased

rework, scrap or replacements?

If you answered yes to any of those

questions, your measurement information

may be of such poor quality that it pre-

vents you from making sound decisions

related to your product or service.

The reliability of the decisions made

using measurement information that

results from testing is heavily influenced

by the relationship of the product’s test

tolerances and performance distribution

to the measurement process uncertainty.

The smaller the uncertainty is, the better

the decisions.

Traditionally, the quality of measure-

ment information is influenced by the

management of three things:

1.Conditions: This includes controlling

the situational influence factors, invest-

ing in the training of personnel and

maintaining a robust internal quality

review.

2.Processes: This includes rigorous test

design, documenting and validating

procedures and software, and using

process control measures.

3.Measuringandtestequipment

(M&TE):This includes ensuring the

equipment meets the environment and

process conditions for the proposed

use, and calibrating the M&TE periodi-

cally to maintain the desired levels of

measurement performance.

After you purchase the M&TE and

verify it is suitable for the intended appli-

cations, its level of performance degrades

with time and use. Accordingly, periodic

calibration is required to maintain the

needed performance levels.

Failing to calibrate your M&TE often

enough can lead to degraded performance

and a negative impact on deliverables.

Calibrating too often may raise the per-

formance of the equipment but at higher

support cost and reduced availability.

The need to calibrate your M&TE is

clearly identified in ISO 9001:2008 sub-

clause 7.6, which states: “Where necessary

to ensure valid results, measuring equip-

ment shall … be calibrated or verified, or

both, at specified intervals, or prior to use,

against measurement standards traceable

to international or national measurement

standards.”

Metrology and calibration laboratories

are plentiful, but questions remain. How

do you specify the calibration require-

ments for your M&TE? How do you

manage the process of getting it calibrated

so the service you receive meets your

needs and that the equipment is calibrated

only as often as needed? And how do you

ensure all of this is cost effective?

This basic answer is to define an M&TE

calibration system or program that manag-

es and satisfies your calibration needs via

a traceable system of competent calibra-

tions (see Figure 1). The documentation

of this calibration system would typically

be included in the organization’s quality

manual and would also apply to suppliers,

depending on the influence they have on

the company’s products.

Still, more questions remain. Do you

need to start from scratch to define your

calibration system? What elements should

you include in the system requirements?

How will you know your system will

produce measurement results compatible

with other organizations?

The answers to these questions are

found in a national consensus standard

from the American National Standards

Institute (ANSI) and the National Confer-

ence of Standards Laboratories Interna-

tional (NSCLI), Z540.3-2006—Require-

ments for the Calibration of Measuring

and Test Equipment.

Examining the standardIn 2003, a group of experts from industry

and government met to develop a standard

for establishing the technical requirements

for M&TE calibration. The resulting stan-

dard bridges the gap between the ISO 9001

requirement to have your M&TE calibrated

and having the calibration performed in a

purposefully designed process.

Filling the gap between calibration needs and calibration labs / Figure 1

M&TE = measurement and test equipment

M&TE calibrationlaboratory

services andtraceability

Calibrationsystem

(ANSI/NCSLZ540.3)

Need for M&TEcalibration

(ISO 9001:2008,AS9100C, etc.)

M&TEapplications—

test andmeasurement

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July 2010 • QP 55

Conceptually, the standard provides

for managing M&TE performance through

a system of functional components. Col-

lectively, these ensure the equipment’s

accuracy and reliability are in accordance

with identified performance requirements.

The standard brings a calibration systems

approach into any organization looking to

improve its products, services and bottom

line through the effective management of

M&TE performance.

In many organizations, M&TE is used in

R&D, testing, evaluation, production and

support of products and services provided

to a wide range of internal and external

customers. The information gained from

the use of the equipment contributes to an

organization’s knowledge of its product

or service and to the associated deci-

sions about quality and suitability for the

intended applications.

The validity of measurement results

and decisions made based on those results

are significantly affected by the accuracy

of M&TE. As a result, the equipment is of

particular importance to the organization’s

success.

The standard prescribes requirements

for a calibration system that ensures the

continued accuracy of M&TE used to

support the organization’s endeavors.

The scope of the implementation may be

limited to the implementing organization

when the calibration system is within the

organization.

Or, when the system extends beyond

the organization, it may include a flow

down through contracted or outsourced

functions. If that’s the case, the organiza-

tion may implement the standard based

solely on business strategy or on meeting

customer contract conditions or require-

ments.

Part of a systemThe types and applications of M&TE, the

calibration of which may be managed

using a calibration system, are broad.

They may include equipment used for final

testing of a complete product or compo-

nents of the product, or equipment used

directly in providing a service, such as in

the healthcare industry.

M&TE that plays a more indirect

role—such as supporting R&D, monitoring

utility parameters or evaluating compo-

nent selection—is also addressed by the

standard and is included in a calibration

system in which the equipment may affect

product or service quality. From a practi-

cal standpoint, it’s not often the equipment

is expected to be excluded from calibra-

tion system management unless there is a

clear rationale for the decision.

Converting M&TE performance

requirements to specific requirements for

use in the calibration system may require

further interaction between the end user

of the equipment and the organization’s

quality, calibration and engineering opera-

tions. M&TE calibration requirements are

parameters used by the calibration system

Failing to calibrate your measuring and testequipment often enough can lead to degradedperformance and a negative impact on deliverables.

M&TEapplicationrequirements

M&TE calibration requirements

CalibratedM&TE

NISTand SI

M&TE = measurement and test equipmentNIST = National Institute of Standards and TechnologySI = International System of Units

Traceability

suppliers

Calibration service requirements

Measurementreliability and

calibration intervalsCalibration qualityrequirements

Customer

Assessment andimprovement

Product–service:• Research• Development• Production• Test and inspection• Support• Operations• Maintenance

Calibration system:• General requirements• Implementation• Assessment and improvement

Calibration system / Figure 2

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QP • www.qualityprogress.com56

Measure For Measure

to ensure the equipment meets the defined

performance requirements.

The principal parameters are:

• Calibration required or not.

• Measurement quantity test require-

ments (such as ranges, values and

tolerances).

• Allowable measurement uncertainty or

false-accept risk of the calibration.

• Allowable measurement reliability or

uncertainty growth at the end of the

calibration period or interval. Note that

the allowable uncertainty growth is the

magnitude of the difference between

the uncertainty of the calibration

results and the M&TE’s measurement

uncertainty requirements.

These parameters control the degree to

which M&TE managed by the calibration

system meets the performance applications

and the organization’s expectations. Figure

2 (p. 55) shows an overall view of the func-

tional components and process flow within

an organization’s calibration system.

Making improvementsCompared with previous standards, Z540.3

provides mechanisms to improve the qual-

ity of M&TE performance, its management

and the related calibration services. Some

of these improvements include:

• Adding M&TE application performance

criteria to ensure the compatibility of

calibration intervals and calibration

services.

• Improving requirements for calibration

procedures, including use objectives,

tolerance test criteria, measurement

decision risk criteria, test uncertainty

ratio determination and validation

criteria.

• Requiring traceability to the Interna-

tional System of Units and improving

compatibility with the official mea-

suring system from the U.S. National

Institute of Standards and Technology.

• Providing improved criteria for calibra-

tion intervals and the use of measure-

ment assurance processes.

• Providing requirements for optional

use of accredited calibration services.

• Reducing the number of overall re-

quirements.

• Adding consolidated requirements for

assessment, quality control monitoring

and system improvement.

Of these, three topics raised the most

discussion during the early development

of the standard: measurement decision

risk, test uncertainty ratio and use of cali-

bration laboratories accredited to ANS/

ISO/IEC 17025. These topics and others

are addressed in the NCSLI’s Handbook

for ANSI/NCSL Z540.3. In addition,

accreditation bodies now offer assess-

ments of calibration laboratories to Z540.3

requirements.

And finally …During the development of the new stan-

dard, the NCSLI-sponsored ANSI Accred-

ited Standards Committee Z540 invested

a significant amount of time and effort

ensuring the requirements for M&TE

calibration fulfilled needs unmet by other

standards in a way that would improve

compatibility with international standards.

The committee was also conscious of the

need to express the requirements in a

straightforward and explicit manner to fa-

cilitate implementation and interpretation.

As with any change, there are costs

and benefits the standard brings. But, in

the end, the benefits to all stakeholders

and the bottom line outweigh the modest

costs. QP

Stephen Doty is program director of the U.S. navy’s Joint naval Audit Certification program in Corona, CA. he received an MBA in defense ac-quisition from the naval postgraduate School in Monterey, CA. Doty chaired the commission that developed the handbook for AnSI/nCSL Z540.3.

MeAsureMent Mess?Keeping your equipment functional is only half the battle in achieving productiv-ity. Calibration is crucial, and QP has the tips you need to make sure everything checks out. Find what you need in past Measure for Measure columns by visiting www.qualityprogress.com.

DeL CALDweLL is owner of CCG, a consulting group in Claremont, CA. he earned an associate’s degree in science from San Diego City College. Caldwell is past president of the national Conference of Standards Laboratories International.

shAreyour QuAlityJourneyEach month, QP includes an interesting, personal quality story in its “Quality in the

First Person” column. If you are interested in sharing your story—how you got into

the quality field, how it has helped your organization or your career or how quality

has enhanced your personal life—e-mail [email protected].

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QP • www.qualityprogress.com44

Measure For Measure BY Dilip Shah

Calibration evaluationHow to ensure your test and calibration supplier meets your needs

My last column covered how to select

a test and calibration supplier based on

its accredited status.1 But what do you do

when a supplier does not have accredita-

tion to the required quality standard? How

about when the particular test or calibra-

tion item is not covered under the scope

of accreditation? What if you need to visit

and evaluate the test and calibration sup-

plier to verify customer requirements?

In this column, I’ll look at some of the

ways to prepare for the assessment pro-

cess, which can help evaluate the supplier

in an objective manner. The emphasis

in the following tips is on assessing key

requirements for test and calibration, but

the guidance provided may be used for

assessing internal test and calibration

facilities.

Too many test and calibration as-

sessment audits are not performed well

because the objective has not been

defined or communicated with the sup-

plier. Sometimes, the person performing

the assessment does not have the right

qualifications or a good checklist for the

organization. To be sure, there are pitfalls

at every turn. Hopefully, a few tips will

help you avoid them.

Qualifications and preparationThe assessor must have knowledge of the

test and calibration parameters and how

to audit them. The assessor must be objec-

tive and unbiased. The assessor must fol-

low rules of civility and treat the audited

party with respect and be professional

in his or her conduct while performing

the assessment. The ASQ Quality Auditor

certification is a good qualification to have

for general auditing skills.

Lack of preparation is a major cause

of failing to achieve assessment objec-

tives. When preparing for an assessment,

you must have knowledge of the standard

being assessed or the customer’s require-

ments.

Some advance work may be required to

review the supplier’s documentation, such

as knowledge of the quality system, poli-

cies, procedures and work instructions.

The required documentation should be

requested in advance. The customer may

need to sign binding nondisclosure or con-

fidentiality agreements to obtain certain

documentation from the supplier.

The checklist used should be specific

to a standard, plus any other customer

requirements. There are a number of rea-

sons to use a checklist, the main one being

to maintain the integrity of the audit.

The checklist helps the auditor by

identifying and communicating the scope

of the audit, providing a structured list of

points to evaluate, guiding the course of

the audit, keeping the pace of the audit

and ensuring all aspects of the audit are

assessed. But the checklist is only as good

as the auditor’s preparation. An inadequate

checklist with no preparation will do little

to ensure the adequacy of the audit.

Preparation should also include com-

municating the assessment objectives with

the laboratory so it is prepared to satisfy

assessment inquiries. An audit should

not be a surprise. A preliminary schedule

shared with the supplier laboratory gives

the laboratory an opportunity to prepare

test and calibration processes for the

assessment and have qualified personnel

available to demonstrate methods and

answer questions.

Performing the assessmentMost test and calibration activities or pro-

cesses are witnessed by the auditor to de-

termine conformance. When witnessing the

process, verify training and competence of

personnel conducting tests or calibrations.

Training records may need to be examined.

Some training records may reside in HR,

so make sure you notify the department in

advance if you need to retrieve them.

Make sure any environmental conditions

critical to test or calibration activities are

monitored with traceable equipment. Also,

monitor at least the last year’s worth of

environmental records for the area to verify

the laboratory’s ability to maintain the ap-

propriate environment, including tempera-

ture, relative humidity and vibration.

Check that procedures used are cur-

rent, relevant and maintained under the

laboratory’s document control system.

Any supplementary documentation, such

as manufacturers’ manuals and external

standards, should also be examined for

relevance. Any software that is used by the

laboratory must be sufficiently validated.

Measurement uncertainty must be taken

into account when the laboratory reports

the measurement results for compliance.

a checklist is only as good as the auditor’s preparation.

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september 2010 • QP 45

Standards such as ANSI/NCSLI Z540.3

also require determining probability of

false accept (PFA) risk. If that is required,

ensure the method the laboratory uses to

determine PFA is acceptable and verified.

Determine who has the authority to re-

ject or accept test results, as well as who

can stop and resume workflow processes

when a nonconformance occurs.

Make sure equipment used is trace-

able and calibrated on a predetermined

schedule, taking into account frequency of

use and other appropriate factors. Equip-

ment calibration history and records of

previous calibrations must be maintained.

There should be a process to recall equip-

ment for calibration and to quarantine any

equipment due for calibration. Sample

how the process is used with a few ex-

amples to verify effectiveness.

During the assessment, verify measure-

ment (metrological) traceability hierarchy

of the equipment and standards used. The

traceability hierarchy should be satisfied

to the international system of units up to

the National Metrology Institute level or to

the accredited laboratory that calibrated

the equipment.

Any statistical sampling techniques

used must be valid and appropriate for the

test and calibration activity. If software is

used, ensure it is sufficiently validated.

Note how processes are tracked during

the test and calibration activity, including

handling, conditioning and tracking items

while in the laboratory’s possession. Is the

laboratory environment suitable for the

test and calibration activity? Are storage

and staging areas sufficient? Is equipment

handled properly and safely? What precau-

tions are observed?

Note any best practices and preven-

tive actions taken to ensure confidence in

the lab’s capability to measure and report

results. Typical examples of best practices

are statistical process control, interlabo-

ratory comparisons, and intermediate

checks of standards and equipment used.

Study the sample test or calibration

report generated to ensure it includes the

right information, is unambiguous and

meets customer or standards require-

ments. The sample report should include

the relevant measurement results—includ-

ing as-found and as-left data if appro-

priate—and associated measurement

uncertainty information for satisfying

measurement traceability requirements.

Any raw data used to report measure-

ment results should be retained by the

laboratory. If in doubt, examine other test

and calibration reports generated by the

lab, which should have a record retention

system and processes in place. Sample a

few examples of previous records.

Reporting the assessmentAssessment results should be reported in

a clear, concise and objective manner. The

report should state the facts backed by

objective evidence.

Include all objective evidence sam-

pled—for example, calibration report No.

1234 dated June 30, 2010, was sampled

for equipment XYZ and recall record for

equipment ABC to verify equipment recall

process. State if processes or items ob-

served were in conformance or why they

were not in conformance, and reference

the standard or requirement.

Any observations or opinions should be

clearly stated as such. Observations and

opinions may provide opportunities for

improvement or preventive actions for the

laboratory being audited.

Many audits place a passing criterion

of at least 80% based on the checklist. If

all items on the checklist are weighted the

same, this may not be a good idea. For

example, if everything was satisfactory ex-

cept for lack of measurement traceability,

then the whole system or process should

fail. This is where the technical expertise

and experience of the assessor is useful.

Passing should also depend on the

criticality of the process being audited. It

is better to accept the laboratory as the

supplier after it has met all the require-

ments, including corrective actions for

nonconformances, rather than just making

sure it has a passing grade.

Closure and follow-throughEnsure that during closure, all items per-

taining to the assessment are discussed.

The laboratory must understand all items

in the assessment report, including non-

conformances. There should be no sur-

prises at the closing meeting or thereafter.

Both parties should have a clear

understanding of audit findings. If there

are nonconformances, expectations for

timely corrective actions need to be com-

municated to the laboratory, including any

requirements for root cause analysis.

Ensure all corrective actions and the

associated objective evidence satisfies

the issues raised through the nonconfor-

mances cited. If a follow-up assessment is

required, follow these same tips.

To develop a comprehensive test and

calibration checklist, consult standards

such as ISO 17025, ANSI/NCSLI Z540.3

and ISO 10012. That foundation, plus the

guidance provided here, should result in a

thorough assessment process. QP

RefeRence1. Dilip Shah, “Supplier Demand,” Quality Progress, May 2010,

pp. 48-50.

BiBliogRaphyamerican National Standards institute and the National

Conference of Standards libraries international, ANSI/NCSLI Z540.3-2006—Requirements for the Calibration of Measuring and Test Equipment.

international Organization for Standardization, ISO/IEC 17025:2005—General requirements for the competence of testing and calibration laboratories.

international Organization for Standardization, ISO/IEC Guide 99:2007—International vocabulary of metrology—Basic and general concepts and associated terms.

DILIP ShAh is president of E = mc3 Solutions in Medina, Oh. he has more than 30 years of experience in metrology and applications of quality and statistics in metrology. he is a past chair of ASQ’s Measurement Quality Division and Akron-Canton Section 0810, and is co-author of The

Metrology handbook (ASQ Quality Press, 2004). Shah is an ASQ-certified quality engineer and calibration technician, and a senior member of ASQ

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QP • www.qualityprogress.com50

Measure For Measure BY JaY Bucher

Where Does It say That?Clearing up the FDA’s calibration requirements

I’m StIll amazed by how many experi-

enced, trained, professional calibration

personnel do not know what the U.S.

Food and Drug Administration regulations

say about calibration requirements.

During my workshops and company

audits, I’ve found that many professionals

might not know there is a requirement,

don’t know where to find it, don’t know

what it actually says and, in the worst case

scenario, don’t know what it means. With

that in mind, I’ll clarify what the FDA says

about calibration requirements, and I’ll also

tell you how to meet those requirements.

Follow the codeAll of the FDA requirements can be

found in the Code of Federal Regulations

(CFR). The specific areas that calibration

professionals should be concerned with

usually fall under one of these sections of

21 CFR:

• Part 58, good laboratory practice for

nonclinical laboratory studies.

• Part 110, current good manufacturing

practice (cGMP) in manufacturing,

packing or holding human food equip-

ment and utensil maintenance.

• Part 211, cGMP for finished pharma-

ceuticals.

• Part 606, cGMP for blood and blood

components.

• Part 820, cGMP that governs the

methods used in—and the facilities and

controls used for—the design, manu-

facture, packaging, labeling, storage,

installation and servicing of all finished

devices intended for human use.

The part that goes into the greatest de-

tail—and in my opinion still encompasses

the spirit of the other parts—is covered

under 21 CFR Part 820.72, which covers

inspection, measuring and test equipment:

(a) Control of inspection, measur-

ing and test equipment. Each manu-

facturer 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 manufactur-

er 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 proce-

dures shall include specific directions and

limits for accuracy and precision. When

accuracy and precision limits are not met,

there shall be provisions for remedial ac-

tion to reestablish the limits and to evalu-

ate whether there was any adverse effect

on the device’s quality. These activities

shall be documented.

(1) Calibration standards. Calibra-

tion standards used for inspection, mea-

suring, and test equipment shall be trace-

able to national or international standards.

If national or international standards are

not practical or available, the manufactur-

er shall use an independent reproducible

standard. If no applicable standard exists,

the manufacturer shall establish and main-

tain an in-house standard.

(2) Calibration records. The equip-

ment identification, calibration dates,

the individual performing each calibra-

tion, and the next calibration date shall

be documented. These records shall be

displayed on or near each piece of equip-

ment or shall be readily available to the

personnel using such equipment and to

the individuals responsible for calibrating

the equipment.

A recurring theme throughout this sec-

tion is the phrase “shall be documented.”

I can’t stress enough that if an action is

taken or performed but is not documented,

as far as any inspector or auditor is con-

cerned, it did not take place.

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November 2010 • QP 51

Five stepsMy calibration philosophy for meeting

FDA regulations and ISO standards is

simple and covers the requirements found

in 21 CFR Part 820.72:

1. Say what you do. Write down the

process or procedure required to calibrate

on all test equipment that makes a quan-

titative measurement. If the item requires

calibration, it also needs to be recalibrated

on a regular basis.

2. Do what you say. Use the previ-

ously referenced calibration procedures.

It’s not enough to go to the trouble of writ-

ing, validating, continually updating and

improving your calibration procedures if

you don’t use them.

I understand that in the real world—af-

ter performing dozens, hundreds or even

thousands of calibrations on a particular

type or model of test equipment—cali-

bration practitioners should be able to

perform the procedure in their sleep. But

a couple of items come into play here.

The FDA requirements and ISO stan-

dards call for using written calibration

procedures. You aren’t using a calibration

procedure if that procedure is in a binder

located in a different room or building

and not where the actual calibration is

performed.

Calibration practitioners (as well as any

technician, supervisor or manager working

in an FDA or ISO-regulated environment)

must know where to find the information

needed to perform their job and are not

required to memorize any of it. They must

have the procedure or work instruction

needed to perform the task at hand. That

means it must be in the immediate area

and opened to the appropriate page.

Why is this important? It sets a good

example for others who walk past. It

shows new personnel that your company,

department or group is in compliance with

this aspect of the requirement. If there are

changes to the procedure and the techni-

cians have been trained on those changes,

it is easy to follow them without relying

on memory or the help of others.

Even though some tasks become so

repetitive that they’re almost automatic,

we are all creatures of habit. Having the

appropriate calibration procedure on hand

during each and every calibration is a

habit we should all want.

For the record3. Record what you did. The calibration

record is one of the critical steps in the

quality calibration program (QCP). Without

the calibration record, which will include

the as-found, as-left and standard read-

ing from the calibration, many important

aspects would be lost.

Was the test equipment within toler-

ance? Only by having the record can

you be certain and can your supervisor

(or anyone signing off as the second set

of eyes) confirm the tolerances were

met. When an item is found to be out of

tolerance, those readings are critical in

determining if there might be an impact on

a product or process. That relates, in turn,

to the possibility of product recall.

4. Check the results. Without the

data, you can’t ensure tolerances were

met, standards were not overdue to be

calibrated when they were used, and the

correct calibration interval and calibration

dates were calculated.

5. Act on the difference. This falls

under 21 CFR Part 820.72.b: “When ac-

curacy 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 activi-

ties shall be documented.”

If the test equipment did not meet its

tolerances, what program is in place to

cover this part of the regulation? This is a

double-edged sword because it also refers

to your calibration standards.

When calibration equipment returns

from being calibrated, what happens when

it is found to have been out of tolerance

while you have been using them to cali-

brate your company’s test equipment? Do

you have a program in place to perform

reverse traceability for that standard?

Can you easily identify all of the test

instruments that were calibrated using

out-of-tolerance standards? How much

did that affect the items they were used to

calibrate? Again, you need the calibration

record to help make that determination.

The five aspects of a QCP are just the

tip of a large iceberg in the calibration

process. It is an all-encompassing program

with many areas that must be covered to

meet the strict regulations and standards

delineated by the FDA and ISO. You must

know what the requirements are if you’re

going to comply with them 100%. QP

BIBlIographyFood and Drug administration, “code of Federal regulations

Title 21,” www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm.

you must know what the requirements are if you’re going to comply with them 100%.

Jay L. Bucher is president of Bucherview Metrology Services LLc in DeForest, WI. he is editor and coauthor of The Metrology handbook and author of several books, including Paperless records, ethics: The Final Frontier and Paperless calibration compliance for National and Interna-

tional Standards & regulations. Bucher is a senior member of aSQ, the chair of the measurement quality division and a certified calibration technician.

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Beth Carbonella Senior Accreditation Officer American Association for Laboratory Accreditation (A2LA) Phone: 301.644.3219 Email: [email protected] Web: www.A2LA.org

FOR IMMEDIATE RELEASE:

A2LA Accredits New York City Special Inspection Agency

April 30, 2013, Frederick, MD-The American Association for Laboratory Accreditation (A2LA) is proud to announce the initial accreditation of Municipal Testing Laboratory, Inc., a Special Inspection Agency, to ISO/IEC 17020. Municipal Testing Laboratory, Inc., located in Hauppauge, NY, received its initial accreditation on April 26, 2013 after a thorough review of their quality management system and technical competence. They chose A2LA accreditation to meet the requirements of the New York City Building Department as required by Section (c)(3) of 1 RCNY 101-06.

A2LA is one of the select approved accrediting bodies recognized by the New York City Building Department for the accreditation of Special Inspection Agencies. According to Chapter 17 of the NYC building code, special inspection is defined as, “inspection of selected materials, equipment, installation, fabrication, erection or placement of components and connections, to ensure compliance with approved construction documents and referenced standards as required by this chapter or elsewhere in this code or its referenced standards.” Special Inspection Agencies are now required to register with New York City and become accredited if they are inspecting larger projects, following a decision from the New York City (NYC) Department of Buildings (DOB). A deadline of May 13, 2013 was set for agencies performing Special Inspections on “Class 1” projects.

ABOUT A2LA:

The American Association for Laboratory Accreditation (A2LA) is a nonprofit, non-governmental, public service, membership society. A2LA provides world-class accreditation and training services for testing and calibration laboratories, inspection bodies, proficiency testing providers, reference material producers and product certifiers. Services are available to any type of organization, be it in the private or government sector.

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Larnell Simpson Director of Marketing/Medical Affairs American Association for Laboratory Accreditation (A2LA) Email: [email protected] Phone: 301.644.3248 ext. 231 Web: www.A2LA.org

FOR IMMEDIATE RELEASE

A2LA Receives 2013 Best of Frederick Award

Frederick, MD, May 21, 2013 -- For the third consecutive year, A2LA has been selected for the Best of Frederick Award in the Professional Standards Review Board category by the U.S. Commerce Association (USCA).

The USCA "Best of Local Business" Award Program recognizes outstanding local businesses throughout the country. Each year, the USCA identifies companies that they believe have achieved exceptional marketing success in their local community and business category. These are local companies that enhance the positive image of small business through service to their customers and community.

Nationwide, only 1 in 120 (less than 1%) 2013 Award recipients qualified as Three-Time Award Winners. Various sources of information were gathered and analyzed to choose the winners in each category. The 2013 USCA Award Program focuses on quality, not quantity. Winners are determined based on the information gathered both internally by the USCA and data provided by third parties.

U.S. Commerce Association (USCA) is a New York City based organization funded by local businesses operating in towns, large and small, across America. The purpose of USCA is to promote local business through public relations, marketing and advertising. The USCA was established to recognize the best of local businesses in their community. They work exclusively with local business owners, trade groups, professional associations, chambers of commerce and other business advertising and marketing groups. Their mission is to be an advocate for small and medium size businesses and business entrepreneurs across America.

About A2LA The American Association for Laboratory Accreditation (A2LA) is a nonprofit, non-governmental, public service, membership society. A2LA provides world-class accreditation and training services for testing and calibration laboratories, inspection bodies, proficiency testing providers, reference material producers and product certification bodies. Services are available to any type of organization, be it in the private or government sector.  


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