A2LA Supports Government
Agreements
The National Institute of Standards and Technology (NIST) has formally recognized A2LA
as competent to accredit Electromagnetic Compatibility (EMC) testing laboratories for
purposes of the United States- European Union Mutual Recognition Agreement (U.S.- E.U.
MRA). News of the recognition was conveyed in a March 5 letter to A2LA from Ms. Mary
Saunders, Chief of the Global Standards Program at NIST.
"To date, NIST has designated 14 A2LA-accredited laboratories as Conformity
Assessment Bodies (CABs) under the U.S-E.U. MRA," Ms. Saunders stated. "The
European Commission has confirmed these designations and these laboratories are now
authorized to provide documentation in support of U.S. manufacturers seeking to
demonstrate compliance with European legal, regulatory and administrative requirements
covered under the EMC Annex of the MRA."
NIST has also appointed A2LA as an authorized accreditation body under the provisions
of Phase I of the Asia-Pacific Economic Cooperation (APEC) MRA for Conformity Assessment
of Telecommunications Equipment, according to Ms. Saunders. As a result, more than 40
A2LA-accredited testing laboratories are authorized to assess the conformance of
telecommunications products to the legal, regulatory and administrative requirements of
the APEC MRA.
NIST's recognition of A2LA is based on a memorandum of understanding (MOU) between NIST
and the National Cooperation for Laboratory Accreditation (NACLA), and on A2LA's status as
a NACLA-recognized accreditation body and a signatory to the NACLA Mutual Recognition
Arrangement. Under the MOU, the NACLA process of recognizing laboratory accreditation
bodies was determined to be an acceptable alternative to direct NIST recognition under the
National Voluntary Conformity Assessment Systems Evaluation (NVCASE) procedures.
Questions related to A2LA's recognition by NIST should be directed to Ramona Saar rsaar@a2la.org.
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Wyoming Agency Relies
on New A2LA Accreditation Program
The State of Wyoming Department of Environmental Quality (WDEQ) has announced its
intent to rely on data provided by laboratories accredited by A2LA in its Water Quality
Division's Leaking Aboveground and Underground Storage Tank (LAUST) Remediation Program.
The criterion requiring A2LA accreditation is included in the WDEQ's Policy Number 35.
To meet the needs of the WDEQ, A2LA created specific program requirements: the A2LA
Wyoming Remediation of LAUST Laboratory Accreditation Requirements. These are similar to
the A2LA Environmental Program Requirements but accreditation is specific to TPH
(DRO,GRO), BTEX, naphthalene, MTBE, total cadmium, total chromium, and total lead
analyses. A2LA began to offer this new accreditation program in March.
The stipulation that analytical laboratories must be accredited by A2LA applies whether
the lab wishes to do work directly for the WDEQ or indirectly through a subcontractor.
Laboratories that are not accredited in this new A2LA program will not be allowed to
perform work for Wyoming's LAUST Remediation Program.
For further information about the new accreditation program, please visit our website
at www.a2la.org. Also, you may contact Randall
Querry at A2LA [Phone (301) 644 3221 or email rquerry@a2la.org]
and Karen Halvorsen at WDEQ [Phone (307) 777 7077].
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A2LA Addressing
Concerns About Measurement Uncertainty
As has become clear from the many phone calls received at A2LA headquarters, the
measurement uncertainty requirements of ISO/IEC Standard 17025 are presenting testing
laboratories with a daunting challenge. A2LA is taking a number of steps to help these
laboratories to comply with the requirements. It is hoped that the following initiatives
will generate desired guidance for our laboratory constituents:
- On the international front, the European cooperation for Accreditation (EA) has formed
an expert group to draft guidance on measurement uncertainty for testing labs. The
Asia-Pacific Laboratory Accreditation Cooperation (APLAC) is planning for a
"measurement uncertainty in testing workshop" to be held in Hong Kong in June.
A2LA staff will be active in both of these groups and will share with A2LA testing
laboratories the relevant information that emanates from them.
- An A2LA document giving the program requirements for dimensional inspection labs has
been drafted. It explains how to calculate uncertainty in dimensional measurements and
provides numerous examples covering everything from calipers to the interoferometric
calibration of a gage block. The document is now being reviewed by technical experts. Once
their comments are received and processed, it will be submitted to the A2LA Criteria
Council for final approval. Once approved, it will be available to our accredited and
applicant laboratories.
- The A2LA web site has a growing bibliography of currently available guidance documents,
both domestic and foreign.
- Measurement uncertainty within the testing laboratory will be a primary agenda topic at
the 2001 A2LA Assessor Conclave being held in early April in Columbia, MD. Assessors will
discuss uncertainty issues in each of the various fields of testing for which A2LA offers
accreditation. The proceedings of the Conclave discussion will be published and made
available to testing laboratories.
- Finally, A2LA staff is always receptive to requests for help and/or information from
representatives of laboratories and others concerned about the uncertainty issue. Thomas
Adams, A2LA Metrology Manager, is the primary point of contact for these requests. His
phone number is 301 644 3219; email address, tmadams@a2la.org.
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A2LA Interim Policy
on Measurement Uncertainty for Testing Laboratories
The following A2LA policy was issued in August, 2000, and will be updated
periodically by A2LA until the transition from ISO/IEC Guide 25 to ISO/IEC 17025 is
completed.
It is acknowledged that the concept of measurement uncertainty is relatively new for
the testing laboratory community. As such, A2LA is taking a practical approach to
implementing the ISO/IEC 17025 measurement uncertainty requirements for testing labs (see
next page). The following interim policy should allow laboratories sufficient time to
train staff members and then develop and apply procedures for measurement uncertainty:
A2LA applicant and accredited testing laboratories can temporarily satisfy a deficiency
cited against Clause 5.4.6.2 and/or 5.4.6.3 of ISO/IEC 17025 by submitting a documented
implementation plan with their 30-day corrective action response. The implementation
plan must contain the steps the laboratory will take to write and implement their
procedures for estimating measurement uncertainty prior to the lab's next on-site
surveillance (for new labs) or annual review (for renewal labs).
Procedure
A) The assessor(s) must identify and document in the method review matrix the
applicable measurement uncertainty category (I-V below) for the tests identified on the
lab's proposed scope of accreditation:
I. Qualitative or semi-quantitative tests for which measurement uncertainty budgets
will not be required.
II. Well-recognized test methods that specify limits to the values of the major sources
of uncertainty of measurement and specify the form of presentation of calculated results.
In such cases, the laboratory is considered to have satisfied this clause by following the
test method and reporting instructions.
III. Chemical, environmental, or biological test methods based on published regulatory
or consensus methods (examples: FDA, EPA, AOAC, ASTM, APAH/AWWA) for which the measurement
uncertainty is not defined in the method. For these types of tests, uncertainty can be
estimated using the standard deviation of laboratory control samples (lcs) of more than 50
points. (This does not include laboratory-developed methods which require validation and
fall under IV or V.)
IV. Test methods that need identification of the major components of uncertainty and a
reasonable estimate of measurement uncertainty.
V. Test methods that need identification of all components of uncertainty and detailed
measurement uncertainty budgets calculated in accordance with published methods that are
consistent with those described in the ISO "Guide to the Expression of Uncertainty in
Measurement". Note that in order to determine if the uncertainty affects compliance
to a specification limit (ISO/IEC 17025, 5.10.3.1 c - see below), uncertainty must be
estimated. Categories III, IV or V apply to these types of methods.
B) Within 30 days after the assessment, the laboratory must submit the implementation
plan with their normal corrective action response. The plan must include at least the
following:
- Identification of staff who are currently trained in or for which training on
measurement uncertainty is planned.
- Timeline for obtaining training (within one year).
- Timeline for writing the procedure for estimating measurement uncertainty in accordance
with ISO/IEC 17025 Clause 5.4.6.2 (within one year).
- Timeline for estimating measurement uncertainty in accordance with the lab's written
procedures (must be completed within one year, prior to a new lab's surveillance or a
renewal lab's annual review.)
C) Objective evidence of compliance, including the procedure for estimating measurement
uncertainty, and the resulting documented uncertainty budgets and uncertainty values,
where relevant, will be reviewed in accordance with the following schedule:
- For new laboratories, compliance will be verified by the assessor during the
laboratory's on-site surveillance.
- For renewal labs, compliance will be verified by the assessor during the annual review
process (or sooner at the laboratory's request).
The laboratory will be billed by A2LA for the actual cost of the assessor's time to
review the objective evidence. Notes: Applicable ISO/IEC 17025 Clauses on measurement
uncertainty for testing labs:
ISO/IEC 17025, section 5.4.6.2 states the following:
Testing laboratories shall have and shall apply procedures for estimating uncertainty of
measurement. In certain cases the nature of the test method may preclude rigorous,
metrologically and statistically valid, calculation of uncertainty of measurement. In
these cases the laboratory shall at least attempt to identify all the components of
uncertainty and make a reasonable estimation, and shall ensure that the form of reporting
of the result does not give a wrong impression of the uncertainty. Reasonable estimation
shall be based on knowledge of the performance of the method and on the measurement scope
and shall make use of, for example, previous experience and validation data.
Note 1: The degree of rigor needed in an estimation of uncertainty of
measurement depends on factors such as the requirements of the test method, the
requirements of the client, and the existence of narrow limits on which decisions on
conformance to a specification are based.
Note 2: In those cases where a well-recognized test method specifies limits to
the values of the major sources of uncertainty of measurement and specifies the form of
presentation of calculated results, the laboratory is considered to have satisfied this
clause by following the test method and reporting instructions (see 5.10) ISO/IEC 17025,
section 5.4.6.3 states:
When estimating the uncertainty of measurement, all uncertainty components which are of
importance in the given situation shall be taken into account using appropriate methods of
analysis.
Note 1: Sources of uncertainty include, but are not necessarily limited to, the
reference standards and reference materials used, methods and equipment used,
environmental conditions, properties and condition of the item being tested or calibrated,
and the operator.
Note 2: The predicted long-term behavior of the tested and/or calibrated item is
not normally taken into account when estimating measurement uncertainty.
Note 3: For further information, see ISO 5725 and the Guide to the Expression of
Uncertainty in Measurement. [Please contact A2LA to obtain reference documents that
describe acceptable methods of estimating measurement uncertainty.]
ISO/IEC 17025, section 5.10.3.1 c states the following: [Test reports shall, where
necessary for the interpretation of the test results, include the following: ]
C) Where applicable, a statement on the estimated uncertainty of measurement; information
on uncertainty is needed in test reports when it is relevant to the validity or
application of the test results, when a client's instructions so require, or when the
uncertainty affects compliance to a specification limit.
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Diversity of Laboratories Now
A2LA Accredited
More Than 1,500 Laboratories Now A2LA Accredited
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Revised Documents
The following A2LA documents have been revised:
- A2LA Food Microbiology Program Requirements - January 2001;
- A2LA Proficiency Testing Requirements For Accredited Testing and Calibration
Laboratories - March 2001;
- A2LA Putting Green Materials Testing Program Requirements - March 2001.
Copies of these documents have been mailed to the laboratories affected by the
revisions and to all assessors. To obtain a copy, please visit the A2LA web site at www.a2la.org.
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'Some People Fish; I Wire'
| The headline sums up the career and the passion of Greg
Gogates, Chair of A2LA's Assessors Committee and the subject of this issue's assessor
profile. It all started when his father, a junior-high shop teacher, gave Greg a few old
radios to tinker with. Then, his family moved, becoming early residents in a development
of new houses. "I followed the electricians from house to house, as they worked on
the many houses under construction. I became their unofficial assistant - pulling wires
and being their 'gofer'."
While in high school, he earned his FCC license and gained his first experience with
computers in the Teletype days. At Widener College, where he earned a degree in electrical
engineering, he built the college FM radio station ("even put the antenna on the roof
myself"); and, when the school's master electrician retired, Greg took over for him.
Greg's exceptional expertise in the electrical/radio/electronics fields has enabled him
to have a busy and productive career in two major U.S. industries: first, nuclear power;
and now, pharmaceuticals, with a specialty in auditing and validating software. One other
interesting item under his belt is Theatrical Automation. He has designed and built
automated scenery and props that have appeared in numerous Broadway shows and amusement
parks. He works as a consultant, under the banner of FASOR Technical Services Inc, which
he established in 1980. |
Mr Gogates |
| Nuclear power plants were FASOR's clients in the 1980's.
"I was an Instrumentation & Control Start-up Engineer. That meant reviewing the
designs and testing all the systems of a new nuclear plant. Once we got the plant up to
100% of its capacity, we'd turn it over to the power company."
His assignments took Greg to many countries in North and South America, including
Brazil. That's where he met the woman he would later marry. He's been back to Brazil often
since, of course, and learned Portuguese ("so I can understand what my mother-in-law
is saying about me"). He has 3 girls, 10, 14, & 16 who keep him busy. His desire
is to teach them how things work and how to repair them. ("It will help them from
being 'ripped off' when they are on their own").
Nuclear power hit the skids in the 1990s, and Greg was somewhat disenchanted anyway,
because he felt the industry was slow to embrace new technology. So, in mid-decade, he
switched to one of the more progressive industries, drug manufacturers. His primary client
is an industry leader, which has a big manufacturing facility in West Point, PA, not far
from Greg's home. His specialty there centers on software validation. Part of the job
involves on-site auditing at the software firms - but not Microsoft, which "doesn't
let any outside auditors into their facilities."
What led him to become an A2LA assessor?
"In 1994, one of my volunteer jobs was chairmanship of IEEE Std 498 - 'Calibration
and Control of Measurement and Test Equipment Used in Nuclear Power Facilities'. I got
word that ANSI-NCSL Committee Z540 was developing a new calibration standard being modeled
after Guide 25, and I became the IEEE adjunct to the committee meetings at NIST. John
Locke, then A2LA President, was at the meetings. I showed some interest in accreditation
assessments and John encouraged me to become an assessor for A2LA."
Greg is a lead electrical/EMC assessor and, because pharmaceuticals keep him very
occupied, he participates in only about 10 assessments a year. Although qualified to lead,
he's happy to be a team member. In fact, it has some advantages. "When I leave the
lab, I like to have all my work completed. I want to get on the plane and back to other
things."
The entrance meeting is Greg's favorite part of assessments. "It gives me an
opportunity to see a new lab operation. It's amazing to see how things get done.
Particularly so with electrical testing labs. The high voltage ones are really
fascinating." He fondly recalls his initial A2LA assessment - a NASA failures lab in
Houston. "They tested every piece of equipment that ever malfunctioned in the space
program."
A2LA has benefited from Greg Gogates' passion for computers and electronics. He
appreciated the value of the exchange of ideas that takes place at the yearly Assessors
Conclave and knew it ought not to be a one-time-a-year experience. So, at his instigation,
A2LA established an electronic listserv for assessors. Now the dialogue and sharing are
continual.
While part of the Z540 committee in 1994, Greg suggested that a listserv would be a
good way to evangelize the ISO25 methodologies. To that end he started his own listserv on
ISO Guide 25 . It now has more than 1000 participants from around the world. Participants
seek advice from experts and peers plus share ideas on interpretation of difficult
elements in the standard - like measurement uncertainty. It's a help to accreditation
bodies by handling questions that might otherwise come their way.
Greg has other suggestions to enhance the art of lab accreditation. He thinks A2LA
should establish a program for software testing firms. And he is an ardent proponent of
replacing paper reports with electronic reports. He's come across one computer
manufacturer "whose lab has no more paper reports; it's all PDF files. That's a great
advance."
He thinks the signature as an indication of approval can be nearly eliminated as well,
pointing out that the operative word in the requirements is "approval" not
"signature." Approvals can be ascertained by process and a quality audit of the
process. Next month, Greg will give a paper on "Role-Based Approvals vs.
e-Signatures," at a prestigious conference of scientists involved in the development,
manufacture, quality control and regulation of pharmaceuticals.
What is Greg's philosophy of assessment? It's based in part on what he observed during
his years of work in nuclear facilities.
"We had regular visits from NRC inspectors. Some of them were nice; but some of
the others were mean, difficult to deal with. Before I got my first A2LA assignment, I
went to one of the inspectors I admired and got some good pointers on how to be an
effective assessor."
Here's Greg Gogates' creed:
- Look at the rules and apply them. I am open to convincing by the lab staff, but, in the
end, if it's wrong, it's wrong.
- Be friendly. Keep it light. The assessor is a guest in the lab, which is paying for me
to be there.
- Listen. Use half sentences. Lab staff will tell you a lot more than you'd ever expect,
if you spend more time listening than speaking.
- A deficiency is not a deficiency until it's proven.
- It's not a deficiency if it doesn't violate something written in Standard 17025 or one
of the guidelines.
- Don't approach an assessment with preconceptions or biases.
- The more you know, the more you know you don't know!
|
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2001 A2LA Board of
Directors
Chairman
Douglas Berg
GM Powertrain
First Vice Chairman
Dean Flinchbaugh
Bethlehem Steel Corp.
Second Vice Chairman
William Kavanagh
SAIC
Secretary
Steve Watson
DuPont Co.
Treasurer
Frank Banda
Software Performance Systems, Inc.
Chairman, Criteria Council
Kenneth Stoub
Group Seven Environmental Services
Chairman, Accreditation Council
Douglas Lentz
Consultant-Flint Metal Center (GM)
Past Chairman
Steven Bowser
Bowser-Morner, Inc.
Board Members
J. Trevor Boyce
Microbac Laboratories, Inc.
Russell S. Flowers
Silliker Laboratories Group, Inc.
James E. French
American Institute of Aeronautics
Joe Greenslade
Greenslade & Company
|
William Hanrahan
Consultant
William Harral
Arch Associates, LLC
Beverly Jones
Basell USA, Inc.
Richard Kistner
Raba-Kistner Consultants, Inc.
Michael Pellegrino
Defense Logistics Agency
Charles Pryor, Jr.
National Stone, Sand and Gravel Association (NSSAG)
Joan Sterling
ITS/Intertek Services
Patrick Toner
Consultant
John Wehrmeyer
Consultant
Herbert Wilgis
Penniman & Browne, Inc.
Liaison
Bob Graves
U.S. EPA - Environmental Monitory
Systems Laboratory - Cincinnati
(EMSL-CI)
Liaison
Paul Schlecht
National Institute for Occupational Safety and Health (NIOSH)
Legal Counsel
James Hostetler
Kirkland & Ellis
|
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We Welcome Our Newest
Staff Members
| A2LA has added two experienced professionals to its staff to
enhance its capability to meet the accreditation demand from calibration laboratories.
They are Antonio Maceo, formerly a metrologist/metrology engineer with the Weights and
Measures Section of the Maryland Dept. of Agriculture; and Tim Osborne, formerly a
radiation health physicist and Quality Manager of the calibration and radiochemistry
laboratories of a consulting firm. Mr. Maceo moved to the U.S. 29 years ago from his
native country, Jamaica. He holds B.S. degrees in physics and engineering physics from
Morgan State University in Baltimore. His leisure interests include metaphysics, national
security issues and traveling.
Mr. Osborne is from Englewood, NJ and currently lives in Pasadena, MD. He began his QA
career in the U.S. Navy as a nuclear engineer on a fast attack submarine. When he
completed his tour of duty, he attended the University of Maryland and obtained a B.S.
degree in nuclear engineering. He began working for the consulting firm while still in
college. He is married and has one son. Sports are a favorite pursuit - volleyball,
soccer, skiing, golf, fishing and scuba diving. He also likes to study foreign languages
and theology. |
Mr. Maceo
Mr.Osborne
|
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A2LA Calibration
Program Growth 1996-2000
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Expiration Notice
The A2LA accreditation of ESG Laboratories (A2LA Certificate No. 420.01), located at
5933 West 71st Street, Indianapolis, IN, expired almost two years ago, on May 31, 1999.
Test reports issued by ESG Laboratories after that date are not covered by A2LA
accreditation.
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2001 Quality in
Laboratory Training Course Schedule
Please visit our web site (www.a2la.org)
for a description of the courses listed below and registration information. The courses
are open to all interested persons; A2LA members can register for a discounted fee*.
Irvine, CA
June 7-8: ISO/IEC 17025 and Accreditation
June 11-12: Measurement Uncertainty
Southfield, MI
Sept. 17-18: ISO/IEC 17025 and Accreditation
Sept. 19: ISO/IEC 17025, The New Standard for Laboratories
Sept. 20-21: Calibration Laboratory Practices
Sept. 24-25: Measurement Uncertainty
Lake Buena Vista, FL
Nov. 5-6: ISO/IEC 17025 and Accreditation
Nov. 7: ISO/IEC 17025, The New Standard for Laboratories
Nov. 8-9: Calibration Laboratory Practices
Nov. 12-13: Measurement Uncertainty
*Note: Membership in A2LA is separate and distinct from accreditation by A2LA. A
laboratory does not have to be a member to become accredited, and membership does not
equate to accreditation. To apply for membership, please complete and return the
membership form found on our web site at www.a2la.org.
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Annual Meeting
The A2LA 2001 Annual Meeting will be held on Monday, April 23, from 8:30 to 10:15 am,
at the Sheraton Columbia Hotel, Columbia, MD. To Register for the meeting, please contact
Berta Hakes at (301) 644 3222.
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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
Fax: 301-662-2974
For comments on the newsletter please contact the editor— Ramona
J. Saar, A2LA Quality Manager, at A2LA headquarters e-mail: rsaar@a2la.org
American Association for Laboratory Accreditation