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A2LA News:
The Newsletter of the American Association for
Laboratory Accreditation
July 2000, Number 74

Table of Contents

 

At 2000 Assessor Conclave & Annual Meeting, A2LA Team Prepares For New Challenges

This May, more than 100 individuals from the A2LA assessor corps, Board of Directors and staff gathered in Columbia, MD, for the best part of a week, for intensive training and discussion aimed at equipping "Team A2LA" for the many challenges that lie ahead.

Doug Berg provided ample evidence of success in his Chairman’s State of the Association address at the May 22 Annual Meeting. He reported that a number of new records had been set in 1999:

He noted further that there had been significant growth in the number of attendees at A2LA’s training courses and, at year’s end, a substantial income surplus and a healthy balance sheet.

However, self-congratulation about past accomplishments was not the spirit of the group nor the tone of the many different meetings held in Columbia. Rather, attendees focused on substantial recent and imminent changes in the accreditation world and the steps that A2LA is and will be taking to meet the challenges and continue to improve its performance.

To enable A2LA to satisfy the rapidly increasing demand for its accreditation services, a three-day assessor orientation course was held on May 17-19, under the tutelage of Daren Valentine, A2LA Training Manager. Thirty candidates took the course; at its end they took an exam that must be passed as part of the assessor qualification requirements.Over the course of the next three days, the Accreditation Council and the Criteria Council held meetings and there was a series of training and discussion sessions for veteran assessors. The highlights of these gatherings are described in accompanying articles.

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Annual Meeting: A2LA's Worldwide Role

The culmination of A2LA’s Annual Meeting, held on May 22 in Columbia, was a presentation by President Pete Unger on "A2LA’s Role in the Global Market". Mr. Unger made it clear that A2LA has an important and growing position in the worldwide accreditation arena.

Joan Walsh Cassedy, ACIL Executive Director, opened the proceedings with her keynote address, in which she talked of ACIL’s own worldwide mission and called for an even closer working relationship between A2LA and ACIL. Doug Berg followed with his Chairman’s remarks. The Accreditation Council report was presented by Doug Lentz, that Council’s Chairman. In the absence of Karen Dunning, Chair of the Criteria Council, that Council’s report was presented by A2LA Vice President Roxanne Robinson.

President Unger’s description of A2LA’s global activities could readily lead a listener to conclude that A2LA is one of the most influential accrediting organizations in the world and that it has already succeeded, to a large degree, in accomplishing the Board of Director’s #1 Strategic Goal: To enhance the global acceptance of A2LA accreditation through: Participation in mutual recognition arrangements; Taking leadership roles in accreditation cooperation bodies; and Influencing accreditation standards development.

The following are some of the facts that emerged during Peter Unger’s talk:

Interestingly, the fledgling Mexican accrediting organization, ema, recently contracted with A2LA to help it prepare for evaluation to Guide 58. One more indication of the prominent position that A2LA has achieved and the respect it has earned in countries throughout the world.

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Technical Committee Meetings Help A2LA Chart Future Course

The breadth of A2LA’s interests and issues was on display in Columbia, no more so than on May 20, when four concomitant sessions addressed a series of challenges and changes in assessments of laboratories in widely differing fields. Participating in each session were the assessors who specialize in that particular area of accreditation. Discussions were intense and lively – even heated at times. But the benefits of this kind of open sharing of concerns, experiences, information and ideas were obvious. Input from the field troops of A2LA is an invaluable asset for Board and staff members as they shape the organization's future course. Not to mention the value of these frank exchanges among peers for the individual assessor.

CMT/GEO – FHWA Recognition

The prospect of recognition of A2LA accreditations by the Federal Highway Administration (FHWA) and some modifications in A2LA’s processes that are calculated to hasten that recognition drew a great deal of attention at the meeting of the construction materials testing (CMT) and geotechnical (GEO) assessors. Roxanne Robinson, A2LA Vice President, informed the group that an FHWA official had participated in the recent evaluation of A2LA by NACLA (the National Cooperation for Laboratory Accreditation) and was impressed with the A2LA assessment of a CMT lab. The addition of more emphasis on observing actual tests has clearly helped.

A2LA will do three things to further address FHWA’s requirements:

A number of other matters were also discussed, including: Site testing program requirements; Need for more CMT/GEO assessors; The putting green materials program; Reporting requirements with regard to test methods and procedures; and Recent changes in a number of testing methods.

LSAC – New Program Requirements

During the Life Sciences Advisory Committee (LSAC) meeting, proposed new requirements in the Environmental Accreditation Program (incorporating the NELAC standard - National Environmental Laboratory Accreditation Conference) and the Food Microbiology Program were discussed at length.

Another subject of special interest in the environmental area was the status and implications of EPA’s NELAC program. It was suggested that A2LA’s new environmental requirements include cross references to NELAC’s requirements.

MTAC – "Big Three" Spawns Competition

Initiatives by Detroit’s auto manufacturers and their ramifications in the accreditation world dominated the discussion among assessors at the Materials Testing Advisory Committee (MTAC) session. The Big Three have had divergent views on the value of accreditation and the proper standard (25 vs. 9000) to be applied to labs. However, an automotive group’s recent revision of the QS 9000 standard to include a requirement that calibration be performed by an ISO Guide 25-accredited lab has created such a demand for accreditation (there are 4000 calibration labs in the U.S.) that a number of new accreditation bodies are being established.

A2LA’s policy is to recognize the equivalency only of those other accrediting bodies that are fellow-signatories to an MRA (e.g., APLAC, NACLA, EA). This provides the needed assurance of demonstrated compliance to Guide 58. Therefore, a testing laboratory using a calibration lab not accredited by an "MRA-signatory" accreditor will have a deficiency cited against the A2LA Calibration Policy.

Also discussed were such issues as: The correct format of scopes; Software validation; Assessor consistency and professional behavior; Inclusion of sampling plans in a lab’s scope; and Use of the A2LA logo.

MAC – In The Eye of The Storm

The Measurement Advisory Committee (MAC) meeting attracted a standing room only crowd of assessors, in part because new international measurement uncertainty requirements have become the #1 topic of discussion and debate within the U.S. lab accreditation world. Assessor training in how to apply the new rules was addressed in another session (see related article in this issue).

There were a number of other subjects addressed during the MAC session:

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Improvement Suggestions Fly at Annual Assessors Meeting

"How’m I doing?" was the question Ed Koch used to ask New York’s citizens during his tenure as the city’s mayor. In effect, the A2LA staff asked the same question of scores of A2LA assessors at the Assessors Committee Meeting on May 22. The answer: there’s room for improvement. Not a surprising answer when one considers the increasingly complex, rapidly evolving phenomenon that is laboratory accreditation.

Roughly two dozen concerns and issues, from assessor compensation to website upgrades, generated lively discussion and a great deal of valuable input to staff. The following is a sampling of the subjects addressed in the freewheeling four-hour session that was ably moderated by Greg Gogates, Committee Chairman.

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Training Course Schedule

Columbia, MD
September 11-12 Guide 25 and Accreditation
September 13 ISO/IEC 17025, The New Standard for Laboratory Quality
September 14-15 Calibration Laboratory Practices
September 18-19 Measurement Uncertainty
Honolulu, HI
November 6-7 Guide 25 and Accreditation
November 8 ISO/IEC 17025, The New Standard for Laboratory Quality
November 9-10 Calibration Laboratory Practices
November 13-14 Measurement Uncertainty

To obtain the current A2LA training brochure, please call our Headquarters at (301) 644-3248.

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Transition To ISO/IEC 17025

A2LA’s plan for transitioning from ISO/IEC Guide 25 to ISO/IEC 17025 is outlined in a table printed in this issue of A2LA News. The plan has been approved by the A2LA Criteria Council and endorsed by the Board of Directors.

A2LA’s objective is to have all related documents, including updated General Requirements for Accreditation of Laboratories and the Assessor Checklist, in final form by mid-July.

According to the plan, laboratories undergoing assessments during the period of July 1 through December 31, 2000 have three options: full assessment to 17025, assessment to Guide 25 with gap analysis for 17025, or assessment to Guide 25 only.

For renewal labs, the third option requires an on-site surveillance visit the following year (automatic for new labs). The third option is not available to laboratories being assessed after January 1, 2001. After July 1, 2001, all laboratories will be assessed to 17025.

Assessors will contact laboratories scheduled for assessment during this transition period to ascertain which option they prefer. In the meantime, if you have any questions regarding the A2LA transition plan, please contact Headquarters at (301) 644 3248.

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New Standard Creates Uncertainty - As Well As a Need For Training

"What’s the correct way to comply with the measurement uncertainty protocols of ISO/IEC 17025?" That’s the question on the lips of accreditors and informed testing laboratory managers around the world as they prepare for the day when the new standard will replace Guide 25. Appropriately, therefore, a substantial amount of time at the A2LA Assessor Conclave was devoted to training assessors on the meaning of the measurement uncertainty clause and other new elements in 17025.

While calibration laboratories are familiar with measurement uncertainty, it’s a new challenge for most testing laboratories. They must now deal with it because, according to the A2LA Assessor Training Manual on Measurement Uncertainty for Testing Laboratories, "ISO 17025 is much clearer and also much more prescriptive than ISO Guide 25 in its requirements for testing laboratories on estimating and reporting measurement uncertainty. The expectation is that testing laboratories will estimate and report on measurement uncertainty for most test methods."

Assessors too must wrestle with the challenge of Clause 5.4.6.2 of 17025, a codicil that, as the training manual puts it, "is expected to have a major impact on testing laboratories seeking A2LA accreditation." Currently, there are differences of opinion within the accreditation world about how to interpret and implement the clause’s dictates.

The manual is A2LA’s means of providing guidance on this matter to its assessors and representatives of its accredited laboratories. The manual will be a dynamic document, "because we are sure that over the next few months and years, the application of measurement uncertainty in testing will become more defined in the various disciplines. As such, this training manual will have to be updated periodically."

Laboratory representatives and assessors are encouraged to provide feedback to A2LA staff about the issue of measurement uncertainty and the training manual’s contents. When the first draft of the document is finalized later this summer, it will be posted on the A2LA web site (www.a2la.org) so that all interested parties will be able to access it.

The initial A2LA guidance to testing laboratories is that they "should evaluate the need for estimating measurement uncertainty for each test method using the following guidance:

The closing comment in this draft advisory: "The evaluation of the need for estimating measurement uncertainty should, at a minimum, include an identification and assessment of the major or most significant sources of uncertainty."

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One Man's Experience: Good Science + Uncompromising Ethics = Success

An interview with Earl Hess of Lancaster Laboratories, Inc.

When Earl Hess looks back on the evolution of Lancaster Laboratories, Inc. (LLI), from its humble beginnings in 1961 to its current status as perhaps the largest single-facility, independent, tax-paying laboratory in the U.S., he observes that there was no "secret" to his success. There was, however, a formula: "Lifelong hard work and a lifetime commitment to good science and good ethics." Slow growth in the early years also played a part.

"LLI was not an overnight success. I spent 10 years building its foundation, with little to show for it financially. But the lab developed a good reputation in the region. This provided the basis for our future growth. It’s like putting up a large building – creating the foundation is a lengthy process, but if you don’t do it well, the building won’t stand. During those early years, many of my competitors seemed to be more successful, but most of them have since disappeared from the market."

In the early 1970’s, Earl came to the realization that he could no longer practice hands-on science and build an organization, so he decided to delegate to other competent scientists while he worked on building the business. "I have no formal education in business. So I became a reader of books on how to run a business. One thing I learned was that it came back to living out a form of business consistent with my personal values." One of those values is a bedrock commitment to ethical behavior. That commitment had already faced business challenges.

Early Ethical Dilemmas
"In the early days, before LLI’s reputation was established, one of our sizeable clients was a processing firm that bought slaughter-house waste from rendering companies, refined it to a powder, and sold the powder to feed manufacturers. The valuable ingredient in the waste and the powder is protein; the more protein, the higher the price. Our client would bring us a sample of the waste; we’d test it for

protein, and our data would dictate the price our client paid for the lot of waste. Then, he’d bring us a sample of the processed powder; we’d test that for protein; and the feed plant would buy the powder at a price determined by the protein content. After a while, we began to notice a puzzling pattern: the protein content in the waste sample seemed always to be lower than that in the refined powder. We checked with a chemist at one of the feed plants, whose analysis of the purchased powder was indicating less protein than our analysis of the client’s samples had indicated. We then realized that the client was bringing us phony samples, so he could increase his profit margins in these transactions. As soon as we made this discovery, I went to this client’s office and confronted him. I told him I didn’t want his business any more and I was not leaving his office until he paid the outstanding portion of his account with LLI. I sat in his office for two hours. He finally paid me so I would leave."

At another time when money was still scarce, LLI was doing testing of water treatment products and one manufacturer offered to pay the lab for its services and also pay it a commission on product sales. He was told, "Absolutely not. We never accept any kickbacks."

"Gradually we developed the kind of relationship with clients where they clearly understood that they were going to get true results and they couldn’t buy false ones. It’s a distillation process. Over time, LLI got a reputation such that people knew that there was no point in trying to get Lancaster to bend the rules."

Commitment to Quality
A companion commitment to quality also expressed itself in action in the early days. "I was committed from the earliest days to the highest level of scientific accuracy," Earl recalls. He tells of one situation that occurred more than once. There were times when he would leave at workday’s end not fully satisfied with the results of some of the day’s tests. So he’d come back to the lab at night and redo the tests. "Within the then-small staff, the realization grew that, if you’re in any doubt, you’d better redo the test. When the company was small, staff caught on readily.

"The culture of Lancaster Laboratories was not created overnight. During the incubation period, we established the culture of commitment to integrity and commitment to quality."

An Accreditation Pioneer
At LLI there developed as well a commitment to laboratory accreditation. In the 1960’s and early 70’s, Earl points out, there was lots of price competition but there was no quality standard. "I used to say that my neighbor with an eighth-grade education could start a lab and there’d be no way of distinguishing between it and LLI. Before our reputation was established, price ruled."

Earl Hess was an early joiner of efforts to promote laboratory accreditation. He testified at ACIL-Dept. of Commerce hearings in 1975-76 that led to the establishment of NVLAP. And he was one of the earliest and staunchest promoters of A2LA. He says, "there was clearly a need for a third-party evaluation against a standard. I thought the labs ought to establish the standard and invite a third party in to accredit us to that standard. That would give clients a basis for selecting."

Earl contributed money, time and talent to the early development of A2LA. LLI was one of the first laboratories to have a quality manual, and it became a model for A2LA’s approach to quality. He served on the Board of Directors for a number of years. LLI was also the first lab assessed and accredited by A2LA; to this day, Lancaster carries the #1 A2LA certificate. "In the early days of A2LA accreditation there was no immediate pay-off among clients; A2LA was not yet appreciated or known. But we believed in the concept and it was part of our long-term commitment to the principle of accreditation. In any case, the primary beneficiary of accreditation is the lab itself. It shows the lab where it stands, its weaknesses and its strengths. Any impact on its sales to clients is secondary."

Developing Commitment in a Large Staff
LLI’s dramatic growth began in the early 1980’s, and it made it necessary for management to "formalize the informal," in Earl’s words. "In the early stages you transmit values to staff almost by osmosis. People work shoulder-to-shoulder with the owner. They readily come to understand that no deviation is tolerated. As the lab grows, it’s important to instill this value in middle managers." Accordingly, LLI put heavy emphasis on leadership training. First came a comprehensive commitment to Total Quality Management. Then, in the 1990’s, a major initiative in ethics training. Both programs were introduced "because we needed a system for doing what we did naturally before." Both programs involved every one of Lancaster’s hundreds of employees.

Training Pays Off
Earl described one occurrence that demonstrates the value of this training. "A client came in with a proposal. He said the law required him to submit three analyses and asked the analyst to do five analyses and report to him only the three lowest ones. The technician refused; so he went to the Client Services person – again, no; finally, he went to the sales person, who, like the others, refused. The consistent policy: if we do five analyses you’re going to get five reports. The staff members knew that management stood behind them, and that, even if it meant losing a client, they were to do the right thing."

A Legacy
Perhaps that is Earl Hess’ greatest legacy to today’s lab owners and managers: the truth that the staff takes its cue from the boss. As he puts it, "Some people used to kid me about ‘standing so straight that I would fall over backwards,’ but I demonstrated to all in the company that the President wouldn’t compromise. Top leadership sets the high-water mark for the behavior of the staff. The daily practices of the leader become the standard practices of the company."

One of A2LA’s important goals is to help the laboratories it assesses to improve their performance. In that spirit, A2LA News has interviewed two individuals with special perspectives on a subject of significant concern in the laboratory community: fraud and unethical behavior.

Earl Hess built his company, Lancaster Laboratories, Inc. (LLI), Lancaster, PA, on the foundation of quality and ethics. He sold LLI "reluctantly" in 1995. Since then, he’s been active in promoting ethical behavior, as a member of the Board of Directors of the Institute for Global Ethics and as an ethics trainer.

Jack Farrell, an A2LA assessor, heads Analytical Excellence, of Altamonte Springs, FL, a consulting firm that specializes in helping environmental laboratories meet high standards of quality and ethics. He is also a NATA-trained ISO 9000 lead assessor and an affiliate instructor for the Institute for Global Ethics. Before establishing his firm in 1993, he spent 15 years in various capacities at four different independent testing laboratories.

We believe lab managers and A2LA assessors will benefit from the experiences and observations of Mr. Hess and Mr. Farrell.

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One Consultant's Views on Lab Fraud and Error

An interview with Jack Farrell, President of Analytical Excellence, Inc.

Is lab fraud a bigger problem today than in the past?
Fraud is a legal term that involves intent; I’ll leave that term to the lawyers. What I’ve been working with as a consultant I would characterize as "improper lab practices – improper, illegal and unethical practices." Basically it involves actions like manipulation of a control parameter, like a standard; technically unsound or inauthentic practice; or taking a result that would normally have been outside control limits and bringing it inside the limits.

I don’t think these kinds of practices are more common today. However, there is increased scrutiny of labs’ operations and more effective detection practices. Also, because of technology advances and stiffer economic competition, the temptations are greater.

What are the causes of improper practices?
There are key causes at two levels. At the practical level, the causes involve lab management, training and/or documented systems. At a deeper level, realities like family values and the flexibility of modern technology come into play. The technology explosion allows one to do anything and everything with a PC.

Another cause is a fundamental change in the education of scientists. When I took college chemistry I had to learn the basics of chromatography. Today’s students don’t get the same kind of grounding; now they teach students how to operate a chromatograph. The instrument does all the work. I think some of today’s technicians don’t sufficiently appreciate that the mere fact that an instrument allows him/her to do something doesn’t make it right.

As a troubleshooter, how do you address a problem of improper practices in a client’s laboratory?
Once I have assessed the kind of manipulations that have occurred, I suggest steps like the following:

How about a client who hasn’t yet had a problem – what preventive steps do you recommend?
I think it’s critical that ownership and top management clearly establish an understanding in all employees that ethical practices are the company’s way of doing business. It starts when someone is hired. It’s important to conduct rigorous interviews that address the individual’s values and how he/she handles ethical dilemmas. Thorough background checks are also critical.

Most importantly, management must make clear to the new hire up front the sort of behavior that is expected and the behavior that will not be tolerated – and the consequences of misbehavior.

Then, when rules are not followed, discipline must be swift. Of course, initial and ongoing training of employees is also essential. Management must establish a strong system that stresses preventive actions. The lab’s QA person is very important in early detection of improper practice. Internal audits and corrective action are also important. From the top down, management must enforce a policy of zero tolerance of improper practice and of prompt action when it occurs.

Do you have some tips about ethics policies and ethics training?
Management must appreciate that company ethics policies and codes are not an inoculation against breeches of ethics. The policies must be reviewed and renewed regularly. Training must be conducted every 12 or 18 months. One idea that I like is an ethics contract between the employee and management. I know of one lab where the contract had to be renewed every year before January 15. If the employee hadn’t signed by the 15th, he was gone on the 16th.

As for training, the content is critical. Many programs focus on contracts and conflicts of interest. That’s OK, but it’s not enough. You must also teach staff how to analyze an ethical dilemma and what rules to apply. Many ethical challenges are a matter of one "right" versus another "right".

Any final words of wisdom on this subject?
Two things:

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Use of A2LA Logo on Business Cards Approved by Board

Appropriate use of the A2LA logo, the A2LA plan for transitioning to the new accreditation standard, and additions to the Criteria Council were among the issues addressed by the A2LA Board of Directors (BOD) at its May 23 meeting at the Sheraton Columbia Hotel, Columbia, MD.

The Board voted, once again, to allow A2LA-accredited laboratories to include the "A2LA-accredited" logo on their business cards. The Board reconsidered the issue at the request of laboratory representatives who informed A2LA that use of the logo on business cards was important to their marketing efforts. Individuals must use the A2LA logo in such a way that it does not imply personnel certification, for example, by placing the word "laboratory" or "facility" under the "A2LA-Accredited" logo. The revised logo policy is now available on the A2LA web site at www.a2la.org.

The BOD endorsed the Criteria Council’s decision to approve the A2LA ISO/IEC 17025 transition plan. This transition plan is described in detail in this issue of A2LA News.

The Board also approved the addition of two new Accreditation Council members, Derek Walton and James Munnerlyn, and the addition of a new Criteria Council member, Werner Schaefer.

Finally, the A2LA BOD extended thanks to Karen Dunning, A2LA Criteria Council Chairman and BOD member for the past several years, for her dedication and service. Ms. Dunning recently resigned from the BOD to spend additional time with her young family. She will continue to serve as an A2LA assessor in the mechanical field of testing and as a member of the Criteria Council.

The next meeting of the A2LA Board will be held on October 19-20, 2000 in Frederick, MD.

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No Charge to Enroll in New API Program This Year

The American Proficiency Institute (API) has recently introduced a new proficiency testing program for food chemistry testing laboratories. The program is designed to allow labs to test as many or as few analytes as appropriate for their labs. Analytes include: ash, calcium, cholesterol, dietary fiber, iron, sugars, magnesium, moisture, protein, potassium, salt, sodium, total fat, vitamin A, and vitamin C. The matrices offered in 2000 include infant cereal, meat (30 – 80% moisture), and dairy (NFDM, whole milk, cheese.)

The regular sample kits will be sent out three times per year and will include two samples per matrix. Separate analyses are available for remedial and pre-accreditation requirements. There are presently over 100 laboratories enrolled in the program and API has offered to allow any food chemistry laboratory that is interested in exploring the relevance of the program to enroll for 2000 at no charge.

API has also added several new modules to their Food Microbiology Proficiency Testing Program. They include champylobacter and a HACCP verification program for beef and swine carcass sponge rinse.

Further information can be obtained by contacting API at (800) 333 0958 or by visiting the API web site at www.api-pt.com.

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Nancy & Bob Foncannon

Nancy and Bob FoncannonThey are both graduates of Michigan State University. Both hold engineering degrees. They both went to work for General Motors after college. They met in one of GM’s test labs. After marriage, they worked together at GM for more than two decades. Now they are partners in a consulting business. So it’s only fitting that last year, Nancy and Bob Foncannon of Marcellus, MI became A2LA’s first husband-and-wife assessor team. Nancy Foncannon is the seasoned veteran and lead assessor, with more than 100 assessments to her credit. Bob is the neophyte; his first assessment was in 1999.

Nancy is the President of Quality Systems Consulting, which specializes in Guide 25, ISO 9000 and QS 9000 assessments and training. Bob is the company’s Chief Financial Officer.

The Foncannons recently shared with A2LA News their thoughts about and experiences with laboratory accreditation.

Introduction to accreditation
"I first came to appreciate A2LA and laboratory accreditation in 1988," Nancy explained. "I was the manager of the GM lab in the Three Rivers (MI) Hydra-matic transmission plant. We were the 60th lab accredited by A2LA." She was so impressed by the process that "I wanted to buy the (accreditation) company (a la the old Remington shaver ad). I knew I couldn’t do that, so I decided I would become an A2LA assessor some day." Nancy was particularly impressed by the lead assessor, Sam Gaft, who became her assessment mentor.

Bob’s now a farmer (a.k.a. agra businessman) six months of the year (his specialty is Carpathian walnuts, a Michigan delicacy – he’s the largest source of these walnut seeds in the country). He turned to lab accreditation in late 1998, as a means of activity during the 600-acre farm’s six fallow months and "for some technical stimulation."

Working as a team
Bob believes there’s some added value to the process when the assessors are husband and wife. "We take all our camaraderie with us on the road. When we go back to the hotel after a day at a lab, we talk technical at dinner. We’ve been working together for 20 years, so we’re used to doing this. We work smoothly together and we have a lot of fun and enjoyment as well." Nancy is a mechanical engineer; she specializes in tests on the physical properties of materials and environmental testing ("shake and bake") of automotive components. Bob is an electrical engineer, so he focuses on electrical testing and also on component "shake and bake."

The Foncannons think their union improves the assessment product they deliver. "We get positive feedback," Bob said. "After one assessment, the lab manager recommended us to another lab manager, who called A2LA to say, ‘I want that husband and wife team’."

Hardest part of the job
"Being the bearer of what labs consider to be ‘bad news’ is my least favorite part of assessments," Nancy said. "I try always to deliver it with what I call a spoonful of sugar."

"She does it very well, very tactfully," Bob noted.

Does she have a secret formula? "I use the Socratic approach – mutual discovery. I show the evidence to lab personnel and I let them make up their minds whether there’s a noncompliance. Once they recognize that there is, they buy into it and there is no argument or hassle."

Bob recalls a lab that was found to be having a problem complying with one part of Guide 25 – the same problem that had been identified in its previous assessment. "It became obvious as we probed that they still did not understand that part of Guide 25, so we spent time explaining it. We helped them to understand the meaning and what they needed to do. It came out well, and they were appreciative."

Basic truths
Nancy cited two important realities that guide the Foncannons’ approach to lab assessment.

On working for A2LA

"You’d be hard pressed to find a corps of assessors as qualified as A2LA’s," according to Nancy. "Everyone I talk with is topnotch in his/her own field. I’m very honored to be considered part of that group." The Foncannons also appreciate the support they get from the A2LA staff. "If a big question comes up during an assessment," Bob noted, "we can call A2LA and we’ll get someone who can get the answer for us. We get a lot of support in the field."

The Foncannons look forward to doing A2LA team assessments for years to come. They’re especially looking forward to the fall of 2002. That’s when their daughter Michelle will enter college. Bob and Nancy say they will then be able to build some sightseeing time into their assessment assignments.

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A2LA ISO/IEC 17025 Transition Plan

Assessment Date Options apply to all labs:
(New, Renewal, and Surveillance Labs)		 Documentation Comments
July,2000 OPTION 1:
ISO/IEC 17025
ISO/IEC 17025 checklist
(new requirements bolded)		 ISO/IEC Checklist must
be provided to the assessor(s)
prior to the on-site assessment.
 
OPTION II
ISO/IEC Guide 25 and
ISO/IEC 17025 Gap Analysis
a) ISO/IEC Guide 25 Checklist
b) document gap analysis using
the new ISO/IEC 17025 checklist,
but only filling out bolded (new)
items; Assessors will write up
"gaps" in separate form attached
to deficiency report that includes
the following statements.
"In order to be considered for
accreditation to ISO/IEC 17025,
objective evidence that the
following items have been
addressed needs to be provided
to A2LA with the annual
review/surveillance."
Bolded items of ISO/IEC 17025
Checklist must be completed
and provided to the assessor(s)
prior to the on-site assessment.

 

Response to gaps due at annual
review (renewals) or
surveillance (new).
 
OPTION III
Guide 25 only

ISO/IEC Guide 25 Checklist

All labs selecting this option will
be required to undergo an
ISO/IEC 17025 on-site
surveillance the following year.
(This is already a requirement for
new labs)
January 2001 OPTION I or II only    
July 2001 OPTION I only    

 

Notice

Supplements
The following supplements are posted on the A2LA web site, www.a2la.org. Supplement No. 4 to the 1999 A2LA Directory contains accreditation actions that took place between December 7, 1999 and April 30, 2000. Supplement No. 1 to the 2000 A2LA Directory contains accreditation actions that have taken place since the compilation of the 2000 Directory (i.e., all actions between May 1, 2000 and June 4, 2000).

Status of 2000 A2LA Directory
The 2000 Directory is expected to be ready for distribution by the end of July 2000. All directories mailed to laboratories, users, etc. will be in CD-ROM format only. A limited number of hardcopy directories will be available upon request.

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A2LA NEWS is published by The American Association for Laboratory Accreditation.

5301 Buckeystown Pike, Suite 350
Frederick, MD 21704-8373
Phone: 301-644-3248
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For comments on the newsletter please contact the editor— Ramona J. Saar, A2LA Quality Manager, at A2LA headquarters e-mail: rsaar@a2la.org

 



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