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