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MAY 2003 INDUSTRY NEWS

 

DH Instruments A2LA Accreditation Is Maintained And Their Scope Expanded

The DHI Calibration Laboratory underwent a biennial assessment for A2LA accreditation in 2003 FEB. As a result, A2LA accreditation of DHI calibration services to ISO/IEC 17025 and ANSI/NCSL Z540-1-1994 is maintained. The scope of measurement capabilities has been expanded and best measurement capabilities improved in some areas.

By Mutual Recognition Arrangement, Test Reports and Calibration Certificates issued by A2LA accredited laboratories are accepted on an equal basis by signatories of International Laboratory Accreditation Cooperation (ILAC), European Cooperation for Accreditation (EA), Asian Pacific Laboratory Accreditation Cooperation (APLAC), Inter-American Accreditation Cooperation (IAAC) and many other accrediting bodies.

 

Clock Accuracy by Radio? NIST Paper Tells All

It might surprise you to know that the concept of a radio-controlled clock (RCC)—wall clocks, desk clocks, wristwatches and other timepieces that use special radio signals to keep highly accurate time—is nearly as old as radio itself. Or that RCCs may never be off by more than a fraction of a second at any time. These two facts are among the many in a recently published paper by the National Institute of Standards and Technology (NIST) that explores the history of RCCs, how they work, and the type of radio signals that control them.

Some manufacturers refer to their RCCs as “atomic clocks,” but that description isn’t true. An RCC is primarily a radio receiver tuned to pick up time code signals derived from measurements made by an actual atomic clock. The RCC then uses these signals to synchronize its clock mechanism, yielding very precise time.

Like all clocks, an atomic clock—such as the NIST-F1 cesium fountain device at NIST’s Boulder, Colo., laboratories—works by making the same event happen over and over. The repetition of this event produces a frequency, which is counted to keep time. For example, in a grandfather clock, this repeating event is the swinging of a pendulum. In NIST-F1, it’s the transition of a cesium atom as it moves back and forth between two energy states.

This recent proliferation of RCCs represents one of the most significant developments in the history of timekeeping. WWVB consumer-oriented RCCs were relatively rare until 1999, when NIST increased the station’s radiated output power to 50 kilowatts, a move that allowed the signal to reach all of the United States.

For a copy of paper no. 21-03, contact Sarabeth Harris, (303) 497-3237, sarabeth@boulder.nist.gov. For technical information on RCCs, contact Michael Lombardi at (303) 497-3212 or lombardi@boulder.nist.gov.

 

Transcat Announces Fiscal 2003 Fourth Quarter and Year End Results; Reports Net Profit in the Fourth Quarter

Transcat, Inc., a leading distributor and marketer of test and measurement instrumentation and calibration and repair services, announced financial results for its fiscal fourth quarter and year ended March 31, 2003.

Commenting on the fiscal year 2003 fourth quarter and total year results, Carl E. Sassano, President and Chief Executive Officer, stated: "We are pleased to report a net profit in our fiscal fourth quarter, in a period where our product sales results were significantly impacted by the challenging economic conditions."

"Most importantly, Transcat has completed fiscal year 2003 with a stronger balance sheet, a resized infrastructure and control of its operating expenses. That on-going process has resulted in the consolidation, in March, of two laboratories into our current ten Centers of Excellence. We reduced our laboratory network from 14 to 10 during the past twelve months while, at the same time, achieving improvements in service and efficiency."

"We believe the cumulative effects of the aggressive actions we have taken this year to reduce our cost structure and improve efficiencies have laid the foundation of a profitable business model. We remain focused on achieving profitable revenue growth as economic conditions improve."

Agilent Technologies Reports Second Quarter 2003 Results

Agilent Technologies reported orders of $1.53 billion and revenue of $1.47 billion for the fiscal second quarter ended April 30, 2003. The company reported a GAAP net loss of $146 million, or $0.31 per share, which includes $74 million of net restructuring charges and intangibles amortization. Excluding those items, Agilent reported a net loss of $72 million, or $0.15 per share.

"Our second quarter results were mixed," said Ned Barnholt, Agilent chairman, president and chief executive officer. "We're encouraged by orders and revenue that came in near the top of our expectations, despite world events. Earnings, however, were at the low end of our range because of delays in realizing restructuring savings as well as ongoing pricing pressures in our markets. But, we did achieve $35 million in structural cost reductions during the quarter, and we reduced headcount by nearly 2,500. We remain committed to achieving an operating breakeven of $1.45 billion in the fourth quarter of this year."

Overall, Agilent's second-quarter orders and revenue were in the same range as those of the past six quarters. The company reported a rebound in semiconductor test equipment orders, which reached their highest level in two-and-a-half years. Semiconductor component orders were also seasonally higher, although they remained well below last year's second-quarter spike. Activity in Agilent's other business segments was basically flat compared to the prior year.

Second quarter Test and Measurement orders were down 5 percent from one year ago and were up 2 percent from the first quarter. By market segment, communications test orders were down 7 percent from last year because of weakness in the wireline test market, and were down 1 percent compared to the first quarter. General purpose test was flat compared to last year and up 11 percent from a very soft first quarter despite continued weakness in aerospace and defense. Second-quarter revenues of $652 million were off 1 percent from last year and up 3 percent sequentially. Aggressive restructuring helped comparative operating results. The second-quarter operating loss of $103 million was $29 million better than first quarter results on only $19 million higher revenues. The operating loss was reduced by $69 million compared to last year despite $8 million lower revenues.

 

The Advantages of Being an Accredited Laboratory

The ILAC Public Affairs Committee (PAC) has produced some explanatory material on the value of laboratory accreditation to different sectors. It was recommended by the PAC that this material be also reproduced in ILAC News over several issues to inform ILAC News readers in these sectors about the benefits of accreditation. The information is designed to help laboratories that are currently accredited to more fully appreciate the benefits of their accreditation.

Topics discussed include: A Recognition of Testing Competence, A Marketing Advantage, A Benchmark For Performance, The Choice Between Lab Accreditation and ISO 9001 Certification, and International Recognition For Your Laboratory.

A Recognition Of Testing Competence
Laboratory accreditation provides formal recognition to competent laboratories, thus providing a ready means for customers to identify and select reliable testing, measurement and calibration services. To maintain this recognition, laboratories are re-evaluated periodically by the accreditation body to ensure their continued compliance with requirements, and to check that their standard of operation is being maintained. The laboratory may also be required to participate in relevant proficiency testing programs between reassessments, as a further demonstration of technical competence.

Accredited laboratories usually issue test or calibration reports bearing the accreditation body’s logo or endorsement, as an indication of their accreditation. Clients are encouraged to check with the laboratory as to what specific tests or measurements they are accredited for, and for what ranges or uncertainties. This information is usually specified in the laboratory’s scope of accreditation, issued by the accreditation body. The description in the scope of accreditation also has advantages for the customers of laboratories in enabling them to find the appropriate laboratory or testing service.

A Marketing Advantage
Accreditation is an effective marketing tool for testing, calibration and measurement organisations, and a passport to submit tenders to contractors that require independently verified laboratories. Laboratory accreditation is highly regarded both nationally and internationally as a reliable indicator of technical competence. Many industries, such as the construction materials industry, routinely specify laboratory accreditation for suppliers of testing services.

Unlike certification to ISO 9001, laboratory accreditation uses criteria and procedures specifically developed to determine technical competence, thus assuring customers that the test, calibration or measurement data supplied by the laboratory or inspection service are accurate and reliable.

Many accreditation bodies also publish a directory of their accredited laboratories, which includes the laboratories’ contact details plus information on their testing capabilities. This is another means of promoting a laboratory’s accredited services to potential clients.

Finally, through a system of international agreements accredited laboratories receive a form of international recognition, which allows their data to be more readily accepted in overseas markets. This recognition helps to reduce costs for manufacturers and exporters that have their products or materials tested in accredited laboratories, by reducing or eliminating the need for retesting in another country.

A Benchmark For Performance
Laboratory accreditation benefits laboratories by allowing them to determine whether they are performing their work correctly and to appropriate standards, and provides them with a benchmark for maintaining that competence. Many such laboratories operate in isolation to their peers, and rarely, if ever, receive any independent technical evaluation as a measure of their performance. A regular assessment by an accreditation body checks all aspects of a facility’s operations related to consistently producing accurate and dependable data. Areas for improvement are identified and discussed, and a detailed report provided at the end of each visit. When necessary, follow-up action is monitored by the accreditation body so that the facility is confident that it has taken the appropriate corrective action.

In addition to commercial testing and calibration services, manufacturing organisations may use laboratory accreditation to ensure the testing of their products by their own in-house laboratories is being done correctly.

The Choice Between Laboratory Accreditation and ISO 9001 Certification
Laboratory accreditation uses criteria and procedures specifically developed to determine technical competence. Specialist technical assessors conduct a thorough evaluation of all factors in a laboratory that affect the production of test or calibration data. The criteria are based on an international standard called ISO/IEC 17025 (formerly ISO/IEC Guide 25), which is used for evaluating laboratories throughout the world. Laboratory accreditation bodies use this standard specifically to assess factors relevant to the laboratory’s technical competence, including the:
· technical competency of staff;
· validity and appropriateness of test methods;
· traceability of measurements and calibrations to national standards;
· suitability, calibration and maintenance of test equipment;
· testing environment;
· sampling, handling and transportation of test items;
· quality assurance of test and calibration data.

By this process, laboratory accreditation aims at assuring you or your customers that your laboratory’s test or calibration data are accurate and reliable.

The ISO 9001 standard is widely used in manufacturing and service organisations to evaluate their system for managing the quality of their product or service. Certification of an organisation’s quality management system against ISO 9001 aims at confirming the compliance of the management system to this standard. Whilst laboratories may be certified to ISO 9001, such certification does not make any statement about the technical competence of a laboratory.

International Recognition For Your Laboratory
Many countries around the world have one or more organisations responsible for the accreditation of their nation’s laboratories. Most of these accreditation bodies have now adopted ISO/IEC 17025 as the basis for accrediting their country’s testing and calibration laboratories. This has helped countries employ a uniform approach to determining laboratory competence. It has also encouraged laboratories to adopt internationally accepted testing and measurement practices, where possible.

This uniform approach allows countries to establish agreements among themselves, based on mutual evaluation and acceptance of each other’s accreditation systems. Such international agreements, called mutual recognition arrangements (MRAs), are crucial in enabling test and calibration data to be accepted between these countries. In effect, each partner in such an MRA recognises the other partner’s accredited laboratories as if they themselves had undertaken the accreditation of the other partner’s laboratories.

Recently, almost 40 laboratory accreditation bodies signed a multi-lateral recognition agreement, called the ILAC Arrangement, which should greatly enhance the acceptance of data across the national borders of the signatory countries. Full details for the ILAC Arrangement and the list of signatories can be found on the ILAC website at www.ilac.org.

This developing system of international MRAs among accreditation bodies has enabled accredited laboratories to achieve a form of international recognition, and allowed data accompanying exported goods to be more readily accepted on overseas markets. This effectively reduces costs for both the manufacturer and the importer, as it reduces or eliminates the need for products to be retested in another country. Visit ILAC for more information.

 

Matheson Tri-Gas, Inc. Receives 2003 Supplier Excellence Award

Matheson Tri-Gas, Inc. was selected as this year's award winner in the category of "Special Achievement" by Analog Devices, Inc. Analog Devices, Inc. is a global leader in high-performance semiconductors for signal processing applications.

Analog Devices, Inc. hosted the awards banquet at the Dedham Hilton, Dedham, MA. Steve Harrington, Purchasing Manager for the Wilmington, MA site presented the Supplier Excellence Award to Bill Kroll, President and CEO, Matheson Tri-Gas, Inc. "I want to thank our dedicated Site Services Team for their commitment to excellence over the last three years, as well as the entire Matheson Team for providing outstanding service to Analog Devices, and all our customers, " said Bill Kroll. "Our On-Site Gas Management Program at Analog Devices, as well as at our other On-Site service customers, provides an important program of services...at the customer, for the customer. I also wish to thank Analog Devices for creating the Special Achievement category for the first time this year specifically to honor us."

The Analog Devices, Inc. Supplier Excellence Awards are based on an exacting worldwide formal rating program. Among the factors that determine the recipients are: on time delivery, cycle time, yield, competitiveness, quality and responsiveness. "In the past Analog Devices has recognized capital equipment suppliers but never awarded a supplier based solely on service," said Steve MacKay, Analog Devices, Inc., Fab Equipment Engineering Maintenance Manager.

Matheson Tri-Gas, Inc., is a single source provider of specialty gases, bulk gases, gas handling equipment, and high performance purification systems. The Company also provides support services, engineering services, and systems management services to analytical laboratories and semiconductor manufacturers worldwide. As a member of the Nippon Sanso Corporation group, Matheson Tri-Gas, Inc., is part of a worldwide industrial gas organization focusing on being the single source provider for global customer requirements.

NIST’s Advanced Measurement Lab

In the nearly 40 years since the NIST Gaithersburg, Md., campus was constructed, industry demand for highly accurate measurement standards has grown tremendously. To meet the demands, NIST researchers have developed new ways to more accurately measure, quantify, and calibrate industrially important processes and properties.
However, deteriorating conditions in NIST’s older lab facilities currently are limiting the quality, accuracy, and productivity of many of these efforts.
The Advanced Measurement Lab (AML) will provide superior vibration, temperature and humidity control, and air cleanliness, enabling NIST to provide U.S. industry and science with the best measurements and standards in the world.
Visit http://www.nist.gov/public_affairs/amlbrochure.htm to see the latest pictures and details of the AML's construction progress.


Draft Guidance For Industry: Current Good Manufacturing Practice For Medical Gases

The Food and Drug Administration has made available a draft guidance for industry, Current Good Manufacturing Practice for Medical Gases. The guidance document is being distributed for comment purposes only. The draft guidance contains sections on equipment cleaning and maintenance and equipment calibration and also calibration of laboratory control instruments.

This guidance is intended to provide recommendations on how to comply with the current good manufacturing practice (CGMP) regulations as they apply to manufacturing, filling, transfilling, cascading, transferring, and distributing compressed and cryogenic medical gases. The recommendations should help manufacturers, fillers, and distributors comply with CGMP requirements to ensure the identity, strength, quality, and purity of medical gases. This draft guidance is available at http://www.fda.gov/cder/guidance/3823dft.doc.

 

Wyle Awarded Five-Year Contract To Operate NASA Ames Calibration Laboratory

Wyle Laboratories, Inc., has been awarded a five-year contract by the NASA Ames Research Center to manage and operate the Ames Calibration Laboratory at Moffett Field, California.

The Ames Calibration Laboratory, comprised of nearly 4,000 sq. ft. of laboratory and office space, includes an environmentally controlled laboratory containing workstations equipped with laboratory instruments and standards necessary for the calibration and repair of NASA Ames Research Center equipment.

The works includes calibration and repair of electronic, electro-mechanical, pressure and optical devices. Wyle personnel will be responsible for the calibration of approximately 6,400 instruments and the annual repair of more than 600 instruments.

Wyle already operates the Spaceport Metrology Laboratories located at Cape Canaveral Air Force Station, Kennedy Space Center in Florida; provides calibration services for NASA Langley Research Center in Virginia; and provides commercial calibration services at its Huntsville, Ala. facility.

Wyle Laboratories, Inc., a privately held company, is a leader in providing testing, research and engineering services to commercial, industrial and government customers. The company also provides technical support services, life sciences, special test systems and other technical support services to the aerospace, defense, nuclear, communications and transportation industries.

Dialogue Between NACLA Members And NACLA President At 2003 Annual General Meeting Available

In keeping with his focus on the customer, Dr. Louis Dixon, during the organization’s Annual General Meeting, in March 2003, provided an extensive overview of the “state of NACLA” and then fielded questions from the members.
A summary of the question-and-answer exchanges that followed Dr. Dixon’s presentation is available as a PDF for reading on NACLA’s web site.

 

Pratt & Whitney Measurement Systems, Inc. Purchases Business Unit From Siemens

The Pratt & Whitney Metrology business unit of Siemens Measurement Systems was divested from Siemens Energy & Automation. Incorporated in Connecticut, the wholly owned acquiring company is Pratt & Whitney ® Measurement Systems, Inc.

Pratt & Whitney Measurement Systems is a world leader in the design, manufacture and service of high-quality length metrology (measurement) instruments for use in calibration laboratories. Its standard products incorporate laser and computer technology and measure linear dimensions to sub-micron (micro-inch) accuracy. Pratt & Whitney Measurement Systems manufactures and services its products through an independent Sales Representative channel. With over 11,000 gaging systems installed worldwide, the company has a proven track record of supplying the metrology industry with calibration instruments that are ready for market.

Brand names such as SuperMicrometer®, LabMaster®, Laseruler®, LabMicrometer®, Electrolimit®, and GageCal® have further established industry recognition. For over 140-years, the Pratt & Whitney name is synonymous with high precision and superior quality and its instruments are indispensable to the progress of many industries such as: aerospace, automotive, aviation, machine tool, military/defense, power generation, medical, telecommunications, and calibration service companies.

FARO Technologies Reports First Quarter 2003 Results

FARO Technologies, Inc. reported its third consecutive profitable quarter, fueled by increases in sales and operating margin.Net income was $489,000, or four cents per share, in the quarter that ended March 29, 2003, compared to a net loss of $1.7 million, or 14 cents per share in the year-ago quarter, which ended March 31, 2002.

Sales for the quarter were $13.4 million, a 54.0% increase from $8.7 million in the first quarter of 2002. At March 29, 2003 the Company had a backlog of orders representing approximately $8.9 million in sales, compared to approximately $4.2 million at March 29, 2002. Gross margin was 56.0% for the first quarter of 2003, substantially unchanged from 56.1% in the first quarter of 2002.

Selling, general and administrative ("SG&A") expenses were $5.6 million in the first quarter of 2003, an increase of $0.8 million, or 16.7% from $4.8 million in the year-ago quarter. As a percentage of sales, SG&A expenses were 41.4% in the first quarter of 2003, a 24.6% drop from 54.9% in the year ago quarter. On a sequential basis, SG&A expenses as a percentage of sales in the first quarter of 2003 were down slightly from 41.6% in the fourth quarter of 2002.

Income from operations increased $2.3 million, from a loss of $1.8 million in the first quarter of 2002 to $459,000 in the first quarter of 2003. This increase was a result of an increase in gross profit of $2.6 million plus reductions of $73,000 and $345,000 in depreciation and amortization, and research and development expenses, respectively offset by the $0.8 million increase in SG&A expenses noted above.

Regionally, sales in the United States grew 30.8% to $5.1 million in the first quarter of 2003 compared to $3.9 million in the first quarter of 2002. Sales in Europe increased 83.9% in the first quarter of 2003 to $5.7 million, compared to $3.1 million in the year ago quarter. Sales in the rest of the world in the first quarter increased 58.8% to $2.7 million, from $1.7 million in 2001. The Company also announced plans to open a direct sales office in China by the first quarter of 2004.

"As we previously reported, on a sequential basis, sales in the first quarter of 2003 represented 88.7% of fourth quarter 2002 sales, showing an apparent seasonality, in line with the preceding five-year (1998 - 2002) average of 86.2% when comparing first quarter sales to sales in the fourth quarter of the prior year," said Simon Raab, President and CEO.

"The acceptance of our new products continues to defy the ongoing malaise which is hurting machine tool sales worldwide," continued Raab. "We remain cautiously optimistic that the growth that we have seen in the past few quarters will continue in this tough market. While I was satisfied with the profitability in the first quarter, I had expected a somewhat higher gross margin, following a trend seen in the last three sequential quarters. We continue to examine our processes to improve the gross margin back to traditional levels of 60% or higher," Raab concluded.

April 2003 FDA/PQRI Workshop Presentations Available

The presentations from the April 22-24, 2003 FDA/PQRI Workshop on A Drug Quality System in the 21st Century are available for viewing. The workshop provided an opportunity to share with FDA perspectives and ideas on FDA’s current thinking regarding the FDA drug product quality regulatory system (CMC review and cGMP inspections).

The topics presented on April 22, 2003 include:
· Changes Without Prior Approval An FDA Perspective (PDF)
· Risk-Based cGMPs: Defining Risk and Quality (PDF)
· 21 CFR Part 11 Scope & Application (PDF)
· Benchmarking Semiconductor Manufacturing and its Applicability to Pharmaceutical Manufacturing (PDF)
· Quality Systems and Regulatory Innovation for the 21st Century (PDF)
· Integrating CMC Review and Inspection: A Team Approach (PDF)
· An Investigation into Pharmaceutical Manufacturing Performance and Its Relationship to FDA Oversight and Enforcement Actions (PDF)

The breakout session summaries of April 24, 2003 include:
· Risk-Based cGMPs: Defining Risk and Quality (PDF)
· Changes without Prior Approval (PDF)
· Integrating CMC Review & Inspection Industry Recommendations (PDF)
· Manufacturing Science (PDF)

The presentations from April 22 and summaries from the breakout sessions on April 24 can be read by visiting http://pqri.org/events/workshops/gmp/042203ann.htm#presentations.

NCSLI - Madison, Wisconsin Section Meeting Highlighting ASQ CCT Program

The Madison, Wisconsin section meeting is being held on Wednesday, May 21, 2003. This section meeting will be dedicated to introducing the American Society for Quality's Certified Calibration Technician (CCT) program. Each of the different sections from the Body of Knowledge (BOK) will be introduced, along with the sub-sections and reference materials. Please register for the meeting by calling or e-mailing the contact person, E. Quinn at (608) 662-7917 or equinn@bonecare.com. The meeting will be held at Bone Care, 1600 Aspen Commons, Middleton, WI 53562.

 

NIST Report Features Three Decades of NIST ‘Military Aid’

From cost-effective radar to accurate satellite-positioning systems, the U.S. military has benefited from a long-standing relationship in which the National Institute of Standards and Technology (NIST) has provided innovative measurement and standards support, as well as coordinated calibration services. A new report documents the more than 30-year-long partnership that also has benefited U.S. industry by contributing to the development of thermal imaging equipment, laser pointers and other civilian products.

Examples of the nearly 500 research projects conducted through the partnership include:
· a standard for measuring phase noise in satellite atomic clocks that helps to assure accuracy in the Global Positioning System (GPS);
· an automated method for determining the radiation pattern of large antennas that has reduced repair times greatly;
· highly sensitive equipment for use as standards in calibrating test equipment used to qualify night-vision goggles, improving the safety and reliability of military night operations (technology incorporated by industry for equipment that observes heat leaks in buildings); and
· a variety of standards and equipment for measuring the power in laser beams, including a device that calibrates laser-targeting receivers for military aircraft (which, in turn, has helped assure the safety of various products such as laser pointers).

A Partnership for Advanced Measurement Standards: The Calibration Coordination Group of the Department of Defense and the National Institute of Standards and Technology is available online at http://physics.nist.gov/Divisions/Div844/manual/sp980.html.

 

NIST Peanut Butter Standard Spreads Quality When Used

Some people like peanut butter in sandwiches. Other people mix it in desserts or feed it to squirrels. Now there is a new use for peanut butter—as a quality assurance tool.

The National Institute of Standards and Technology (NIST) recently issued Standard Reference Material (SRM) 2387, a peanut butter sample that has been characterized with state-of-the-art measurement methods to provide values for the amount of fat, protein, vitamins, minerals and other analytes it contains. It is one of a series of food-matrix SRMs that can be used by food manufacturers to validate production and quality control procedures as well as ensure accurate labeling of product content.

The new SRM is the first NIST food-matrix reference material for which values are assigned for 18 individual amino acids—the building blocks of proteins—and for aflatoxins, which are carcinogen substances produced by mold in crops. Peanut butter also is the only SRM that is high in both fat content (about 50 percent) and protein (about 22 percent), making it useful in evaluating the fat and protein content of other food products.

With the release of SRM 2387, one or more reference materials in each of the nine sectors of the Association of Analytical Communities (AOAC) food triangle are now available from NIST. The triangle helps assure the availability of validated analytical methods for all types of foods, so that information for nutrients can be provided on labels.

SRM 2387 already has found a scientific use in evaluating allergen test kits. The Food and Drug Administration (FDA) spiked foods with dilute solutions of the SRM and then tested for the presence of peanuts, which are one of the major allergenic foods. Even a trace of peanut protein can cause serious reactions, even death, if someone is highly allergic.

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