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2002 Annual Meeting
A2LA’s 2002 Annual Meeting will be held on
Monday morning, March 11. For the third consecutive year, the
Sheraton Columbia Inn, in Columbia, MD, will be the meeting site.
The Annual Meeting is free of charge, but space is limited and
reservations are required. So, make your plans now to attend this
event, which is open to all A2LA members, volunteers, assessors and
representatives of A2LA-accredited laboratories. For more
information, please contact Ms. Berta Hakes at bhakes@a2la.org.
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Advertising Policy Revised
A revised A2LA advertising policy that will take
effect on April 30, 2002 has important implications for all A2LA-accredited
laboratories. The major revision of the document, Laboratory
Reference to A2LA Accredited Status - A2LA Advertising Policy,
was approved by the A2LA Board of Directors last year and was sent
to all web subscribers, assessors, and volunteers in late November
2001. The new policy is based mainly on ILAC-G14: 2000, Guidelines
for the Use of Accreditation Body Logos and for Claims of Accreditation
Status. All laboratory representatives are urged to pay particular
attention to the following significant changes to the current advertising
policy:
- Accredited laboratories will no longer be permitted to use the
logo or include reference to A2LA accreditation on reports or
certificates when none of the tests or calibrations
included on the report or certificate are covered under the
accreditation. In the past, laboratories could include the logo
or reference to accreditation in such cases as long as a
disclaimer was included to specify that the tests/calibrations
in question were not covered under the accreditation.
- Accredited laboratories must have a policy and procedure for
controlling the use of the term "A2LA" and the
"A2LA Accredited" logo. The policy and procedure must
be consistent with the new advertising policy requirements. To
review the full document and all the changes, please visit the
A2LA web site, www.a2la.org.
Why was the policy revised? During the past two
years, reliance on A2LA accreditation has increased and, unfortunately,
so has misuse of the A2LA logo and misrepresentations of accredited
status, especially in the calibration area. Many clients are finding
out, after the fact, that reports or certificates received from
an accredited laboratory do not satisfy the requirements of accreditation
and do not comply with the A2LA
Policy on Measurement Traceability. The result is increased
costs to have tests or calibrations repeated and unhappy clients
whose trust in accreditation has been betrayed.
Therefore, accredited laboratories must describe
the limits of their accreditation accurately, in a manner that does
not imply accreditation in areas outside their scope of
accreditation or, in the case of multi-site laboratories, for
facilities not accredited by A2LA.
Only test or calibration reports bearing the A2LA
logo can benefit from the acceptance established through mutual
recognition arrangements among accreditation bodies, and calibration
reports issued by A2LA accredited laboratories must bear the A2LA
logo in order to meet the A2LA
Policy on Measurement Traceability. This means that when using
an accredited calibration laboratory, you must ensure that the lab
is accredited for the calibration in question (refer to the calibration
laboratory's Scope of Accreditation) and you must select the accredited
services offered by the calibration laboratory.
Ethical protocols, concern for your clients, and
the dictates of the accreditation-body mutual recognition
arrangements in which A2LA participates require A2LA to enforce
these new policies assiduously. Misrepresentation of accredited
status may lead to suspension of accreditation.
If you have questions about A2LA's advertising
policy, please contact A2LA Quality Manager, Ramona Saar at (301)
644 3201 or via e-mail at rsaar@a2la.org.
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Summary of the October 2001 Board of Directors
Meeting
At its October, 2001 meeting, the A2LA Board of
Directors tackled an ambitious agenda and made a number of important
decisions.
- It approved revisions to the A2LA's
Advertising Policy and the ISO/IEC
17025 Transition Plan. (See articles elsewhere in this issue
of A2LA News.)
- It approved the 2002 operating budget.
- It approved six new Accreditation Council members: Chuck Blank
(EMC and Calibration), Harry Moody (Calibration), Ray Kletke
(Calibration), Dave Lorenzen (Calibration), Bill Sorrells
(Calibration), and Michael Tedaldi (EMC).
- It approved a revision to the "A2LA Conditions for
Accreditation" which specifies the time frame (30 days)
within which accredited laboratories must provide written notice
to A2LA headquarters of changes in any aspect of the
laboratory's status or operation that affects the laboratory's
legal, commercial or organizational status.
- It decided that the expenses related to assessors' "long
travel delays" should not be borne by the lab/customer.
Instead, A2LA will pay for the assessor's expenses (but not
time) related to the delay. (See article on Financial Services
News).
Finally, the A2LA Board extended thanks to four
departing Board members for their dedication and service to A2LA.
They are Dean Flinchbaugh (A2LA Business Committee Chairman and
Board member for the past nine years); Steve Watson, (A2LA Board
Secretary and Board member for the past eight years); Pat Toner
(Board member for the past nine years); and Beverly Jones (Board
member for the past two years).
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Exceptions to the Traceability Policy
There are exceptions to every rule, including
a policy with which all accredited laboratories should now be familiar:
the A2LA
Policy on Measurement Traceability. As is well known, A2LA requires
that accredited laboratories obtain their calibrations either directly
from a National Metrology Institute or use a calibration laboratory
that is accredited either by A2LA or one of its many mutual recognition
arrangement (MRA) partners.
When using an accredited laboratory, the lab
must ensure that the calibration laboratory's Scope of Accreditation
includes the calibrations in question and that the calibration
laboratory can make measurements to the level of accuracy required
for the specific equipment/standards. Assessors are required to cite
a deficiency if the laboratory personnel do not demonstrate
compliance with the traceability policy. To resolve the deficiency,
the laboratory personnel must then provide evidence of compliance.
However, A2LA headquarters will consider
granting an exception to the traceability policy requirement in
cases where compliance is not possible. The following are examples
of such cases and of the information the applicant for an exception
needs to provide to A2LA staff.
Case 1
You have searched the A2LA web site for an accredited calibration
laboratory and cannot find one for the calibration in question.
You have also searched unsuccessfully for labs accredited by our
MRA partners (on the NVLAP web site, for example). Your corrective
action response to A2LA headquarters would have to include both a
request for an exception and evidence of the results of your
unsuccessful searches for a qualified calibration laboratory.
Case 2
The calibration service provider, although not properly
accredited, is approved by the original equipment manufacturer
(OEM) and authorized to make adjustments to the equipment, and
there are no accredited OEM-approved vendors available. Your
submission to A2LA, in this case, would have to include a request
for an exception, a copy of the OEM-vendor contract, and evidence
of your unsuccessful searches to locate an accredited OEM-approved
vendor.
Case 3
Your laboratory is required by a higher authority (state law or
military requirements, for example) to use a specific calibration
laboratory that is not properly accredited. Along with your
request for an exception, you would be expected to submit citation
of the applicable law or requirements and any additional
information that supports your request.
Case 4
You wish to use a State Weights and Measure lab that is not
currently accredited by A2LA, NVLAP or another MRA partner. A2LA
will consider granting an exception allowing use of this lab if it
is currently recognized by the NIST Office of Weights and Measures
(OWM) State Laboratory Program. (This program is specifically
designed to verify traceability of measurements.) Here, your first
step would be to ensure that the laboratory's scope (issued by the
OWM) covers your calibration needs. Then you would want to provide
A2LA, along with the exception request, a copy of the laboratory's
current OWM Certificate and Scope. One caveat: every year, by
approximately April 1, the NIST OWM publishes on its web site a
list of State laboratories that have lost their OWM recognition.
Therefore, you would need to refer to that site (http://www.nist.gov/labmetrology)
to ascertain the current status of a State laboratory's
recognition, as well as to view information about the OWM program
criteria. If you needed recognition information before the 2002
"de-listings" were posted, you could contact the
laboratory directly for a copy of its Certificate and Scope, or
contact Georgia Harris at the OWM for information about a specific
laboratory
(phone - 301 975 4014, e-mail: gharris@nist.gov).
In all of these cases, the assessor is required
to cite a deficiency during the assessment, because assessors are
not empowered to make decisions on exceptions to the A2LA Policy on
Measurement Traceability. Note also that A2LA does not consider any
increased cost or inconvenience that you would incur in order to
comply with the A2LA policy to be justification for granting an
exception.
For additional information, see the document entitled,
"Exceptions
to the Traceability Policy".
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A2LA Hosts Calibration Assessor Meeting
A2LA calibration assessors attended a one-day
brainstorming session at A2LA headquarters in Frederick, MD, last
November 17. The meeting's objectives were:
- To identify ways to reduce assessor variability during
assessments.
- To improve the format of the Scopes of Accreditation.
- To obtain assessors' comments on a measurement uncertainty
guidance document being developed by staff. (It is hoped that
that the finished guidance document will be made available to
laboratories by the end of 2002.)
The assessors also discussed the importance of
ensuring that laboratories submit complete uncertainty
budgets with their application and suggested that A2LA explain
to laboratories why uncertainty budgets are important.
The next meeting of calibration assessors will
be held on March 9, 2002 in Columbia, MD.
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Calibration Guidance Documents
Are you looking for calibration guidance documents? One source
is the web site for the European Cooperation for Laboratory
Accreditation (EA) (www.european-accreditation.org).
Click on the "Documents" link and, in the EA-10 series,
you'll find a number of guidance documents specific to calibration.
Here is partial list of documents recently posted:
- EA-10/11 - Calibration of Temperature Indicators and
Simulators by Electrical Simulation and Measurement
- EA-10/12 - Evaluation of Vector Network Analyzers (VNA)
- EA-10/13 - Calibration of Temperature Block Calibrators
- EA-10/14 - Calibration of Static Torque Measuring Devices
- EA-10/15 - Calibration of Digital Multi-meters
- EA-10/16 - Estimation of Uncertainty in Hardness Measurements
All these documents include information on
measurement uncertainty.
As with all guidance documents, the technical
information provided should be carefully considered before making
any changes to your own calibration procedures.
If you know of any other sources of calibration
guidance documents, please pass the information along to A2LA so we
can share it with our readers.
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Accredited Lab Plays Major Role in Winter
Olympics
The UCLA Olympic Analytical Laboratory, located
in Los Angeles, California, is accredited by A2LA to perform a
number of toxicology and pharmacology studies on human urine. The
laboratory, which has established a temporary local site testing
facility in Salt Lake City, Utah, is now playing a major role at the
2002 Winter Olympic Games, as the official drug residue analysis
laboratory.
Mr. Ryan Connolly, the Director of
Administration for the laboratory, recently provided A2LA with the
history of the temporary facility.
Early in the planning stages for the Winter
Olympics, the Salt Lake City Organizing Committee selected the
laboratory and agreed to rent space in a location just northwest of
the University of Utah. While in the process of planning the new
facility, and with only seven months to go before the opening
ceremonies, the International Olympic Committee (IOC) informed the
laboratory personnel that the temporary facility would need to be
accredited to ISO/IEC 17025. After the equipment was set up and the
lab's technicians and analysts were brought in from L.A., the
temporary lab was assessed by an A2LA technical expert. The
laboratory achieved A2LA accreditation in January, 2002.
The lab is capable of performing a variety of
different tests in order to determine if banned substances are being
used by athletes. Urine samples are collected after the conclusion
of each event. Two urine samples are taken from the top four
finishers in each event and from two athletes selected randomly. One
of the samples is tested and the second is retained just in case
additional testing is needed. Because most of the events take place
in the afternoon, the laboratory does most of its work in the late
evening and into the early hours of the morning.
If a positive result is obtained as a result of
testing the urine samples, the laboratory must notify the IOC
Medical Commission, which then follows up with an investigation. The
investigation may lead to stripping a winning athlete of a medal.
The process is complicated, controversial, and fast - usually taking
place within 24 hours. It involves legal counsel and retesting of
samples. Since credibility of the laboratory may be questioned, it
is imperative that the laboratory demonstrate its technical
competency through the process of accreditation.
The temporary laboratory accepted it first
"real" samples from athletes on January 30, 2002, when the
Olympic Village opened and will operate through February 27, 2002.
The laboratory will then be dismantled.
The UCLA Olympic Analytical Laboratory was also
selected to run the drug tests for the Paralympics following the
main Games- but the International Olympic Committee has agreed to
allow those samples to be tested at the main facility in Los
Angeles.
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News from Financial Services
- In 2002, the IRS mileage rate for privately owned vehicles has
increased to $0.365 per mile.
- At its October 2001, Board of Directors meeting, a Board task
group reported on the results of its study of the current A2LA
assessor travel compensation policy. The report stated that the
compensation must be based on the principles of fairness,
competitiveness, and shared risk (between A2LA, assessors and
laboratories). Subsequently, the Board reaffirmed the current
formula for calculating assessor reimbursable travel time to and
from laboratories: "the total number of hours traveled less
two hours and divided by two."
- Also, at the October meeting, Board members agreed that the
expenses related to 'long delays' - that is, delays that result
in the assessor having to spend one or more extra nights at a
hotel due to a flight delay/cancellation - should not be passed
to the lab/customer. When such a delay occurs, A2LA will pay for
the assessor's expenses (but not time) related to the delay.
- A2LA continues to accept MasterCard and Visa payments for
membership dues, training invoices, accreditation fees, etc.
Please contact Teresa McCarthy at (301) 644-3229 or
if you would like to make a credit-card payment.
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Understanding Management Review and Internal
Audit Requirements
Management review and internal audit requirements
(clauses 4.13 and 4.14) of ISO\IEC 17025 are often misunderstood
by laboratories seeking initial accreditation.
Help is available. The Asia Pacific Laboratory
Accreditation Cooperation (APLAC) Technical Committee publishes two
documents that cover these topics in detail.
Both guidance documents are highly recommended
to laboratories seeking A2LA accreditation. They are available free
of charge at the APLAC web site, www.aplac.org.
A2LA has been a signatory to the APLAC
Mutual Recognition Arrangement (MRA)
since 1996 and several A2LA staff members hold leadership positions
within APLAC committees. One of the main goals of APLAC is the harmonization
of the accreditation processes of all signatory accreditation bodies.
The APLAC guidance documents not only assist laboratories seeking
accreditation, but also help to ensure the uniformity of the assessments
performed by the many accreditation bodies from Asia-Pacific nations
that are signatories to the MRA. To learn more about APLAC, please
visit its web site.
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Web Site Updates
We are pleased to announce that the searchable
database on the A2LA web site is complete. You can now search the
Scopes of Accreditation of all the A2LA accredited laboratories.
Simply click on the link "Looking
for an Accredited Lab?", enter your search criteria, and
then select the links to the scopes (in pdf format) that you are
interested in reading.
We have also added to our web site a new link
entitled "Helpful
Guidance Documents" and have included a link to Greg
Gogate's paper on software validation. Please feel free to share
this document with anyone interested in understanding software validation.
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Profile of Dick Turner
A refreshing sense of humor and a down-to-earth
manner. That's the impression you take away from an hour's
conversation with Dick Turner, of Vancouver, British Columbia. Then
you reflect on the man's credentials and accomplishments and you
realize: he may not take himself seriously, but he certainly takes
his work seriously. In fact, when it comes to sober pursuits like
accreditation and measurement uncertainty, he's world class.
First the humor. Here's Dick thumbnail
sketch of his life:
"Born in England many years ago.
Sentenced for exceptional behavior to six years education in an
11th century monastery building known famously as Oxford
University . Very cold and damp. Did a bit of physics in between
playing soccer, which took up a lot of time.
"Subsequently spent 10 years in Ottawa,
Canada, getting clothes dry and feet warm in a luxury basement
apartment. An inadvertent excursion to the outside world on a
winter day confirmed the inferiority of the Ottawa climate and
resulted in immediate departure to South Africa.
"Ran the South African national metrology
laboratory (a pale imitation of NIST) for the next 23 years with
no money but high relevancy. Initiated South African laboratory
accreditation (the National Calibration Service, NCS) in 1980 and
left it as CEO in 1996, at which time it had 140 accredited
calibration labs.
"During all that period had an
overabundant interest in estimating uncertainties and promulgated
own document of five pages on the subject for compulsory use by
the NCS accredited laboratories. The document expounded the
doctrine that if it's uncertain it should be easy to estimate, so
don't waste too much time on it.
"Took pity on Canada and returned in
1996, but to an apparently more hospitable part - just as far west
from Toronto as one can get. Now residing north of Seattle and
back to the wet; but at least free from snow at most times.
Retired.
"In 1997 was discovered by A2LA to be
unemployed and being a nuisance to the Canadian laboratory
accreditation body by implying that 16 accredited calibration
laboratories was rather few. In that year was reincarnated as the
world's savior from uncertainty and preached a gospel of salvation
from the GUM at the A2LA conclave.
"Saved America in one afternoon and
prevailed on Daren Valentine to allow general dissemination of the
SSU (Simple Simon Uncertainties) course to all and sundry. This
course has reached astronomical heights of popularity due to the
inclusion of a Punch-and-Judy act which takes up most of the first
one-and-a-half days of the course. {The course is scheduled for
two days but usually finishes shortly after Judy can't take any
more of it.)
"Can more be achieved? One would think
so. A very ambitious project with two major goals has been
initiated, namely - 1. To teach America to make tea properly. 2.
To prevent the self-destruction of America by noise."
The humor is a cover for an outstanding
scientist and a true pioneer in laboratory accreditation. Here are
some of the serious details of Dick Turner's life.
Education and early career. He obtained
his B.A. and Ph.D. from Oxford, specializing in a sphere of physics
akin to nuclear physics. He chafed under the austere conditions of
his life in England and was pleased to get a post-doctoral
fellowship from the National Research Council of Canada. At NRC, he
immersed himself in very basic research with a goal of becoming
"the guy who invented the first laser" but lost the race
to the scientists at Bell Labs.
Emigration to his adopted country, South
Africa. Dick published articles about his laser research in the
prestigious Physical Review. As a result, a colleague from his
Oxford days invited him to come to South Africa for three months to
help build a laser (he got the job done). In the course of the
project, Dick fell in love with South Africa; he and his family
would spend the next 25 years there. He took a position as the head
of the Precise Physical Measurement Division (PPMD) of the Council
for Industrial Research (CSIR), in Praetoria, where he had
"hands-on" responsibility for maintaining the national
measurement standards. "I had a free hand to do what I liked,
as long as it didn't cost anything."
Leaving behind basic research. What Dick
had come to realize was that he liked applied research and working
with industry more than basic "ivory-tower" research. He
was disillusioned with the latter field where he experienced little
responsibility and little accountability. "The major rule in
life was to produce papers and travel to meetings in nice
places." This shift of focus led him to "look for ways to
make our laboratory relevant." One way was accreditation.
An accreditation pioneer. Dick
established the CSIR's National Calibration Service (NCS) in 1980 as
an accreditation program for calibration laboratories; by 1993, NCS
had accredited 140 laboratories. All these laboratories relied on
the PPMD lab for their traceability needs. The metrologists at PPMD
served as assessors for NCS. Meantime, Dick was busy being relevant.
He chaired all 14 technical committees of NCS, took part in many
assessments and wrote all the technical documents. He is
particularly proud of his text on uncertainties, "written in
1983-84, long before the GUM." Through this accreditation
program, "the National Lab interacted with all the scientists
in South Africa's industrial community," to the benefit of all.
In 1993, the NCS became independent of the CSIR, and Dick Turner
became the NCS CEO.
A "Polecat Country." Official
contacts outside of South Africa were limited, during this period,
because, as Dick terms it, "South Africa was a polecat
country" (because of Apartheid). "Taiwan was one of the
few countries that would speak to us." Dick taught the
Taiwanese a lot about measurement science, and they were able then
to make great progress. Dick also had good contacts at the National
Physics Lab in London. And he became friends with the Vice President
of PTB, the German NMI, because the Germans regularly made technical
forays into Africa. One of Dick's crowning achievements, in the
mid-'90s, was negotiating an MRA between NCS and WECC (now part of
EA). NCS became the only national calibration service outside of
Europe to enjoy this status.
Return to Canada - and A2LA. In 1996,
because the increasing civic unrest, Dick Turner left South Africa
and followed his two sons and his wife, Barbara (aka
"Minnie"), to Canada, intending to retire. However, he
found retirement "miserable." So, when Pete Unger invited
him to give a short course on measurement uncertainty to the 1997
A2LA Assessor Conclave, he readily accepted the invitation. (Pete
had learned about Dick from the head of SANAS (which the NCS had
evolved into). Minnie, a retired mathematics professor, taught the
course with Dick. Subsequently, Dick and Minnie ("Punch and
Judy") have conducted a number of similar training courses for
A2LA. In addition, Dick is a leading A2LA lead assessor in the
assessment of calibration laboratories.
Conclusion - his legacy in ILAC. Dick
himself was never active in the International Laboratory
Accreditation Cooperation (ILAC), but he has had a significant
influence on this global organization. He hired and trained Mike
Peet at NCS and, when he was preparing to leave South Africa, he
recommended that Mike be appointed his successor. Mike now heads
SANAS and is serving as the current Chairman of ILAC. In both roles,
he carries forward the sterling legacy of his mentor, Dick Turner.
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Promoting Your Accreditation
Effectively promoting your laboratory's
accreditation to clients and potential clients, using the proper
wording, can be a challenge. Recent marketing brochures published by
the International Laboratory Accreditation Cooperation (ILAC) will
make your job easier.
The ILAC brochures are available free of charge
on the ILAC web site.
Click on the "Publications" link and scroll down to the
links to the pdf documents. The two publications that will be of
most use to accredited labs are the following:
- Why Use an Accredited Laboratory;
- The Advantages of Being an Accredited Laboratory.
A2LA has also placed a link to these documents
on our web site. Check out the new "Promoting
Your Accreditation" link at www.a2la.org.
If you have any questions related to these
documents, please contact A2LA's Technical Manager, Warren Merkel,
who participated in the development of the brochures. He can be
reached at wmerkel@a2la.org.
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Death of an A2LA Founding Father
Most successful organizations can trace their
origins to a handful of "Founding Fathers," men of courage
and vision who, in retrospect, seem larger than life. Just before
Christmas, Earl H. Hess, one of A2LA's Founding Fathers, passed
away; Earl really was larger than life.
Earl Hess died at his home, in Lancaster, PA,
the home which had been the family farmhouse where he was born and
reared. Today, the house has been modernized and the farm has been
replaced by the campus of Lancaster Laboratories, Inc. (LLI), a
spacious, state-of-the-art complex which spans the Leola Pike,
Pennsylvania Route 23.
LLI is a lasting memorial to Earl Hess'
outstanding achievements in the independent laboratory industry and
a tribute to his rock-solid principles: good science, sound business
practices, and commitment to a code of ethics. Earl also took
exceptional care of his employees. During his long tenure at the
helm of LLI, he prided himself on the fact that he never laid off
one of his staff, even during business downturns or slack periods.
And, on the LLI campus, he built three employee "benefits"
that are unique in the independent laboratory world: a day-care
center, an elder-care center and a physical fitness center.
Earl talked about his career and his values -
and his early commitment to A2LA and the importance of laboratory
accreditation - in an interview with A2LA News two years ago (July,
2000, issue). Here's some of what he had to say.
On building a business. "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 disappeared from the market."
Commitment to quality. "I was
committed from the earliest days to the highest level of
scientific accuracy. There were times when I would leave the lab
at the end of the workday not fully satisfied with the results of
some of the day's tests. So I'd come back 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."
Early champion of accreditation.
"In the 1960's and early '70's, 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. 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."
Critical support for A2LA. Given his
conviction about the need for accreditation, it is no surprise
that Earl was one of the first supporters of A2LA and one of the
most generous contributors to A2LA during its critical, formative
years. "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 strengths.
Any impact on its sales to clients is secondary."
So Earl contributed sorely needed money to
the fledgling A2LA. More importantly, he gave - and gave
generously - time and talent. Earl and a couple of other key LLI
staff members helped to develop A2LA's early criteria documents
(no "25" or "17025" in those days). LLI's
quality control manual (one of the first to be developed) became
the model for A2LA and labs seeking A2LA accreditation.
A fitting legacy. Lancaster
Laboratories became the first laboratory accredited by A2LA. LLI
remains an A2LA-accredited lab, proudly carrying Accreditation
Certificate "#1.01." Because of the lasting influence of
Earl Hess, the lab will always be "first among equals."
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Words of Thanks to A2LA
Periodically, an official of an assessed
laboratory provides A2LA with feedback about the assessment
experience. Recently, we were pleased to receive an especially
complimentary letter from Bill Alexander, CEO of TIC-MS, Inc.,
located in St. Louis, MO. With Mr. Alexander’s permission we are
publishing salient excerpts from his letter.
We thank him for the kind words and we commend
the two assessors who made this good impression. Here’s a portion
of the letter.
On December 17th,
18th, 19th A2LA conducted an assessment of TIC-MS, Inc. for
compliance with ISO/IEC 17025 and for technical competence.
TIC-MS, Inc. is
one of the most audited independent labs in the country. Adding
ISO/IEC 17025 to our ISO/IEC Guide 25, AS-9000, ISO 9002, AAR, 10
CFR, DOD/DSS Joint US Canadian Certificate Holder, ANSI Z-540 3rd
party, and a wide variety of customer specific audits by
Pharmaceuticals and Food packagers will make TIC-MS, Inc. one of
the most widely accepted facilities in the country…
For the first
time, TIC-MS, Inc. felt that the members of the assessment team
were truly qualified to assess a calibration laboratory, not only
for the quality program, but for the competency of the lab as
well.
The two A2LA team
members sent to TIC-MS, Inc. had a combined experience in actually
managing calibration labs at the highest possible level of
expertise of over 70 years. Imagine! The team was actually
intimately familiar with every tiny aspect of managing and running
a calibration laboratory.
This was the
single most positive experience in our auditing experience, and as
you know, we have had plenty of experience being audited. We give
A2LA credit for their ability to field assessors of this caliber.
If every certifying and accrediting body would field individuals
with these kinds of credentials and practical experience, the “quality
bar” would be raised to a new height, the playing field would be
leveled for labs competing for recognition and international
acceptance, and the customers of independent labs would finally
get the consistent and competent service they deserve.
We were extremely
pleased with the process and the positive outcome of the
assessment and would like to formally thank A2LA and their
excellent organization.
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Status of Transition to ISO/IEC 17025
On January 1st, A2LA began the final year of our
transition to the new assessment standard, ISO/IEC 17025. This means
that laboratories currently accredited to ISO/IEC Guide 25 must
undergo an on-site assessment or gap analysis to ISO/IEC 17025 in
2002.
The A2LA
ISO/IEC 17025 Transition Plan has been updated and can be accessed
on the A2LA web site. The updated plan's key change applies to laboratories
undergoing ISO/IEC 17025 gap analysis; they will have only 30 days
to respond to the gaps (areas of non-compliance with ISO/IEC 17025)
identified during the analysis.
If your laboratory is currently accredited to
ISO/IEC Guide 25 and you have questions about the transition plan,
please call or e-mail your staff representative here at A2LA.
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Why does A2LA insist on Uncertainty Budgets?
By Philip Stein
The Scope of Accreditation for every calibration
laboratory accredited by A2LA is required to have and state a Best
Measurement Capability, calculated according to the ISO Guide to
the Expression of Uncertainty in Measurement (the GUM). In addition,
there are many circumstances under which testing labs are required
to calculate either full or partial uncertainty budgets. Why is
this so?
ISO/IEC Guide 58, the international standard
which governs A2LA's operations and that of many other laboratory
accrediting bodies, requires in Clause 6.6.1.b (2) that, for
calibrations, an accredited laboratory's documents shall permit
identification of the type of measurement performed, the measurement
range, and best measurement capability (BMC). Further, A2LA adheres
to the definition of BMC found in EAL-R2, which states among other
requirements that such calculations be performed according to the
GUM.
Well, it would seem that combination of policies
settles the question, but not really. A2LA could accept commonly
accepted, reasonable values for the BMC of each parameter and the
individual labs wouldn't necessarily have to address the difficult
task of home growing their own values. In fact, the Measurement
Advisory Committee is beginning to work to accomplish just that. But
there's more.
A laboratory, especially an accredited
calibration lab, has a special responsibility to its customers. Once
accreditation has been granted, A2LA and its sister accreditation
bodies are stating to the public that the accredited lab is capable
of providing a step in the traceability chain.
Traceability requires an unbroken chain of
measurements between the customer and the National Metrology
Institute (NMI), and each link in that chain must contain a value
and must also include either a GUM-conformant statement of
uncertainty or a statement of conformance to an identified
specification. In most cases, customers wanting traceability will
require (or at least be happiest with) a GUM-type uncertainty
statement. The customer then in turn incorporates the reported
uncertainty into his or her own budget to pass on to the next level
down in the pyramid. The bottom line is that in order to be a link
in the chain, a laboratory must be able to correctly calculate
uncertainty budgets.
By requiring demonstration of the calculation of
BMCs, A2LA is assessing each lab's ability to understand its own
measurement processes and provide good uncertainty statements to its
customers. This is a necessary step before A2LA can grant
accreditation because the A2LA logo on a certificate means that A2LA
attests that the laboratory is competent and capable of being a part
of a conformant traceability chain.
So next time you're sweating over an uncertainty
budget, remember that you're doing your part to be a responsible
member of the National Measurement System.
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2002 Board of Directors
A2LA is pleased to present the members of the
A2LA Board of Directors for 2002.
Chairman:
Doug Berg, GM Powertrain
Vice Chairman (First):
John Wehrmeyer, Quality Consultants of NY
Vice Chairman (Second):
William Kavanagh, SAIC
Accreditation Council Chairman:
Douglas Lentz, Consultant - Fling Metal Center (GM)
Criteria Council Chairman:
Ken Stoub, Group Seven Environmental Consultants
Treasurer:
Frank Banda, Software Performance Systems, Inc.
Members:
J. Trevor Boyce, Microbac Laboratories, Inc.
Russell Flowers, Silliker Laboratories Group, Inc.
James French, American Institute of Aeronautics
James Galipeau, Plastics Technology Labs Inc.*
Joe Greenslade, Greenslade & Company
William Hanrahan, Consultant
Bill Harral, Arch Associates, LLC
Richard Kistner, Raba-Kistner Consultants, Inc.
Alex Klein, Inland Steel *
Tony Pellegrino, Defense Logistics Agency
Charles Pryor, National Sand, Stone and Gravel Association (NSSGA)
Joan Sterling, ITS/Intertek Services
Woodward Vogt, Paradigm Consultants, Inc.*
Chuck Wibby, Wibby Environmental *
Herb Wilgis, Consultant
Liaison Members:
Robert Graves, EPA
Charles Parfitt, FDA Office of Regulatory Affairs*
Paul Schlecht, NIOSH
Legal Counsel:
James Hostetler, Kirkland & Ellis
* Newly elected Board members for the 2002
term
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Spring 2002 Training Course Schedule
Title: ISO 17025 and Accreditation
- April 8-9, 2002 - San Francisco, CA
- June 3-4, 2002 - North Olmstead, OH
Title: Introduction to Measurement Uncertainty
- April 10-11, 2002 - San Francisco, CA
- June 5-6, 2002 - North Olmstead, OH
Title: Advanced Seminars in Measurement
Uncertainty
- Calibration Seminar
- April 15, 2002 - San Francisco, CA
- June 10, 2002 - North Olmstead, OH
- Physical/Dimensional Seminar
- April 16, 2002 - San Francisco, CA
- June 11, 2002 - North Olmstead, OH
- Measurement Uncertainty for Life Sciences Laboratories
- April 17-18, 2002 San Francisco, CA
- June 12-13, 2002 North Olmstead, OH
Descriptions of these courses and information on registration costs
can be found in our "Training
Catalog". You can also contact Ms. Julie Stevens, A2LA Training
Coordinator, at (301) 644 3235 (e-mail: ).
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Changes…
After nearly nine years of service to A2LA, our
colleague and good friend, Janneth I. Marcelo, resigned at the
beginning of 2002 to accept a position at Georgetown University Law
Center. At Georgetown she will serve as Manager of the Office of
Admissions. She will be missed.
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NACLA to sponsor first Accreditation Forum in the
U.S.
The National Cooperation for Laboratory
Accreditation (NACLA), a nonprofit corporation established to
coordinate laboratory accreditation activities within the United
States, is sponsoring the first-ever U.S. forum on laboratory
accreditation. The forum, titled "World-Class Accreditation
Today and Tomorrow", will be held April 8-9, 2002, at the Hyatt
Regency Crystal City in Arlington, Virginia. NACLA's Annual General
Meeting will be held in the afternoon on April 9, 2002.
The following are some of the subjects that will
be addressed in the course of the two days:
- Latest Developments in ILAC
- Implementation of ISO-IEC 17025
- ISO Guide 58/ISO-IEC 17011
- How Governments Are Relying on Accreditors
- Measurement Uncertainty
- An Update on NACLA
- The Impact of Dual Accreditation Systems: NACLA and NELAC
- Industry-Specific Accreditation Approaches.
More complete program information and meeting
registration material can be found on the NACLA web site (www.nacla.net).
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