A2LA News August 1998, Number 67

This year marks A2LA’s 20th Anniversary. To celebrate this milestone, A2LA hosted a 20th Anniversary Dinner on May 31 during which the pioneers of the Association were honored. It was a wonderful evening to reminisce about the history of A2LA and to thank key individuals who helped make A2LA the successful organization it is today. A2LA Chairman Steve Bowser officially opened the after-dinner program by introducing Joe O’Neil, Executive Director of ACIL. ACIL is the organization most responsible for the founding of A2LA. Joe presented honorary lifetime memberships to ACIL members who provided exemplary service to the Association: Roger Amorosi, Earl Hess, Gladys Berchtold, and Leland Walker (in absentia). Roger Amorosi served as the Association’s first Chairman. Earl Hess is a former Chairman of the Accreditation Council and represented the first accredited laboratory. Gladys Berchtold was the Board of Directors Chairman during the “lean years”. Leland Walker was Accreditation Council Chairman for 10 years.

A2LA President Peter Unger presented honorary lifetime memberships to John Blair, Chet Grant, Carl Miller, Les Huntley and John Locke. John Blair served on the Board for nine years and was instrumental in securing agreement with BSI Quality Assurance to run the first ISO 9000 courses in the U.S. Chet Grant served as Board Chairman during the developing years and was responsible for General Motors’ acceptance of A2LA accreditation. Carl Miller was the first Chairman of the Criteria Council and member of the Accreditation Council for 10 years.

Les Huntley is the longest-standing, individual member and serves as Chairman of the Measurement Advisory Committee. John Locke served as A2LA President for 10 years overseeing a ten-fold increase in accreditations. Each honoree spoke for a few minutes.

John Locke presented an oral history of A2LA’s first 20 years. This history is described in a booklet entitled “The First Twenty Years – The Evolution of the American Association for Laboratory Accreditation (1978-1998)” and is included with this newsletter.

Steve Bowser closed the ceremonies by thanking all the honorees, staff, assessors and other volunteers who have contributed and continue to contribute their time and efforts to the Association.

This year’s Assessor Conclave, the annual gathering of A2LA members, staff, assessors, Accreditation Council (AC), Criteria Council (CC) and Advisory Committees, was held at the Marriott Hunt Valley Inn in Baltimore, MD from May 27 to June 1, 1998.

The purpose of the Assessor Conclave is to give all those involved in the Association the opportunity to exchange technical information, discuss new A2LA policies and procedures, review new and revised requirements documents, and obtain training. One of the main aims of the gathering is to develop more uniformity in the assessment process and accreditation decisions.

The week’s activities included training sessions for new assessors, AC members and EMC (Electromagnetic Compatibility) assessors, as well as the Annual Meeting of Members, and meetings of the AC, CC, assessors by technical discipline, Environmental Advisory Committee (EAC), Measurement Advisory Committee (MAC), and the Transportation Advisory Committee (TAC). The highlights of the various meetings and training courses are described below.

Twenty-one potential assessors attended an intensive three-day assessor training course. The majority of the assessors trained have technical backgrounds in the fastener, mechanical/automotive, electrical (EMC) and calibration disciplines. Attendees learned about Guide 25, procedures for conducting assessments, and assessment techniques. Instructors for the course included A2LA Training Manager, Daren Valentine, and A2LA Vice President, Roxanne Robinson. Before being accepted as an assessor, each has to pass a written examination given at the end of the course.

Daren Valentine held a one-day ISO/IEC Guide 25 training course for the members of the A2LA Accreditation Council (AC). The members of the AC review assessment information and make the majority of the accreditation decisions for the Association. As such, it is imperative that they have the necessary training to ensure uniformity of decisions. All AC members are also required to pass a written examination. There are currently 48 AC members.

The assessors gathered on May 30 for the Assessor Committee Meeting. Chairman Mitzi Miller led the discussions on a number of key issues including (1) importance of disclosing potential or real conflicts of interest to A2LA, (2) review of the A2LA Calibration Accreditation Policy, (3) review of the responsibilities of lead assessors and associate assessors during team assessments, (4) status of the assessor notebooks, (5) revision of the assessor report evaluation criteria, (6) further instructions on completing the new mini-report, (7) importance of adhering to the RAB audit time guidelines for ISO 9000 registration audits, (8) evaluation of assessor participation on the Accrediation evaluation of assessor participation on the Accreditation Council, (9) ensuring that assessments do not proceed unless the laboratories have paid the necessary fees, (10) status of IATCA application for A2LA’s RAB certified lead auditors, (11) review of the internal audit and management review requirements, (12) guidance on performing surveillance visits and follow-up assessments, and (13) guidance on the practice of written recommendations in assessor reports.

The AC met on May 30. Chairman Doug Lentz led the discussions. When making accreditation decisions, AC members also evaluate the written reports submitted by the assessors. The AC members agreed that the evaluation criteria should be revised. In addition, they agreed that when evaluating team assessment reports, there should only be a single evaluation that would be representative of the team’s effort as a whole in lieu of individual evaluations for each team member.

A2LA monitors each AC member’s performance on turnaround times for accreditation decision ballots to ensure that ballots are being returned within thirty days. Doug Lentz gave a very informative and entertaining presentation about the improvements in the AC turnaround times and the distribution of the AC’s workload.

The CC met on May 30. Chairman Karen Dunning led the discussions. Ms. Dunning reported that in 1998 there will be a much larger volume of work for the CC than in the past. Current documents being reviewed include program requirements for food chemistry and microbiology. The CC is also anticipating receipt of revised Calibration Program Requirements, new program requirements for the dimensional inspection and automotive-EMC laboratories, and new program requirements for an accreditation program of proficiency testing providers.

The status of revisions to ISO/IEC Guide 25 was also discussed. The Guide will become an international ISO standard. Ms. Lynn Neumann reported that the latest draft (DIS 17025) is due to be released for a 5-month comment period. A voting draft would then be released in early 1999 (FDIS 17025) for a 60-day “yes / no” voting period. Once the final version is approved, all A2LA program requirements will need to be revised.

The Conclave General Assembly was held on May 31. This was an opportunity to ask questions of the A2LA staff on policy and procedural issues. Topics discussed included (1) the “grading system” used by the AC, (2) the on-site evaluation of new and seasoned assessors, (3) the use of the new mini-report, (4) the status of A2LA’s current activities in the area of mutual recognition, (5) the need for more detailed supplements to the annual A2LA Directory, (6) the status of ISO/IEC Guide 25, (7) the concern over length of time it takes staff to process applications, and (8) the recent changes to the FQA.

Several technical assessor break-out meetings were held concurrently on May 31. During these meetings, technical assessors discussed a wide variety of issues related to their disciplines and exchanged information and ideas critical to ensuring the uniformity of assessments.

The Environmental assessors discussed (1) ways to improve the mini-report for environmental assessors (2) the need for A2LA to maintain on file SOPs, performance demonstration data and method validation date for all modified or novel lead (Pb) testing methods covered under the National Lead Laboratory Accreditation Program (NLLAP), (3) the development of an assessor e-mail discussion list, (4) the need for review of the estimates of on-site assessment time (5) software validation issues, (6) ensuring validity of calibration curves, and (7) the manipulation of GC/GCMS data.

The Construction Materials and Geotechnical assessors discussed (1) calibration of ovens according to ASTM E145, (2) Site Testing Program Requirements as they apply to CMT and GEO laboratories, (3) the status of the Calibration Accreditation Policy and issuance of waivers of the policy by staff, (4) proficiency testing for CMT laboratories, and (5) deviations from testing methods.

The Fastener assessors discussed (1) the Fastener Quality Act (FQA) Regulation revisions and resulting DRAFT Revised Fastener Program Requirements with A2LA Explanatory Notes, (2) the FQA scopes versus ISO/IEC Guide 25 scopes, and (3) approved signatories under the FQA.

The Calibration assessors discussed (1) use of the National Association for Proficiency Testing (NAPT) by calibration laboratories, (2) ISO/IEC Guide 25-1990 Section 12.1 interpretations, (3) calibration laboratory scope formatting, and (4) proposed revision to the A2LA Calibration Program Requirements.

The Automotive assessors discussed (1) the status of QS 9000 and (2) the time it takes assessors to review information for scope additions.

The Electrical assessors discussed (1) automotive EMC training, and (2) FCC EMC training issues.

The Annual Meeting of A2LA Members was held on June 1. Chairman of the A2LA Board of Directors (BOD), Steve Bowser, summarized some of A2LA’s highlights since the last conclave in 1997. These include (1) successful approval of A2LA under the NIST ABEP program for the FQA, (2) signing of the APLAC MRA, (3) accreditation of the first inspection body, (4) accreditation of the 1000th laboratory, and (5) increase in the number of AC members, assessors, and staff. Mr. Bowser also thanked the Board, AC and CC members for their service to A2LA. He summarized the financial status of A2LA and reported on A2LA’s upcoming move to the new facility in Frederick, MD. This move is scheduled to take place in October of 1998.

Chairman of the AC, Mr. Doug Lentz, provided a summary of the AC activities during the past year and presented statistics showing the improvement in turnaround times for AC packages. He also recognized several AC members who have reviewed the largest number of packages and those with the quickest turn- around times. He thanked all AC members for their service.

Chairman of the Criteria Council, Ms. Karen Dunning, reported on the CC activities for 1997 and on the upcoming 1998 activities. Ms. Dunning also recognized the current Chairmen of the advisory committees and thanked them for their service.

The keynote speaker, Mr. John Donaldson, gave attendees an overview of the current activities of the American National Standards Institute (ANSI). In addition, Mr. Donaldson summarized ANSI’s role in ISO and then reviewed some of the key conformity assessment documents active under ISO Committee on Conformity Assessment (CASCO).

A2LA President, Peter Unger, gave the President’s Report. Mr. Unger identified some future activities in which A2LA will be involved. In addition, Mr. Unger reported that A2LA’s final evaluation by the European cooperation for Accreditation (EA) is expected the week of 14 September. The revision of ISO/IEC Guide 25 to ISO 17025 will mean major revisions of all program requirements documents in 1999. Senior staff is leading teams to evaluate other accreditation bodies in the Asia Pacific Laboratory Accreditation Cooperation (APLAC) and participation in the development of the evaluation process for the National Cooperation for Laboratory Accreditation (NACLA).

On June 1, Art Wall of the FCC led a training course for potential and veteran EMC assessors who perform assessments for A2LA and NVLAP. Major topics of the training course included the following: (1) revisions to the ANSI C63.4 checklist, (2) ensuring that the assessors and laboratories keep up-to-date with the latest FCC interpretations, (3) review of the additional types of equipment that will be covered under the Declaration of Conformity process, and (4) an update on the US-EU MRA.

The 27th meeting of the A2LA Environmental Advisory Committee (EAC) was held on June 1.

Several NELAP (National Environmental Laboratory Accreditation Program) reports were made, including reports on the activities of the Implementation Committee, Environmental Laboratory Advisory Board (ELAB), Accrediting Authority Committee, On-site Assessment Committee Report, Proficiency Testing Committee, and Quality Systems Committee.

Roxanne Robinson, A2LA Vice President, reported that the NELAC (National Environmental Laboratory Accreditation Conference) Quality System Standard (Chapter 5) is consistent with the Guide 25 requirements and A2LA is considering revision of the Environmental Program Requirements to mirror this chapter of the NELAC Standard.

The process of revising the majority of the technology checklists continues. Reports on the revisions of the GC/MS, BOD, ICP checklists were provided.

EAC members also recommended expansion of the EAC bylaws to include chemical and biological disciplines as well.

Paul Schlecht gave a presentation regarding the current efforts to level the playing field for in situ XRF lead measurements. Consistency is needed in three areas: performance standards, QA standards, and verification systems.

At this time, the National Lead Laboratory Accreditation Program (NLLAP) does not include XRF measurements. Mr. Schlecht also discussed the issue of composite sampling for lead (Pb) testing. At this time, use of composite samples is prohibited since the requirements for sample recovery and use of validated methods cannot be met.

The TAC met on June 1. This advisory committee is intended as a forum for interested parties in the automotive industry to develop and provide feedback on A2LA programs and requirements. Due to the FQA and QS9000, interest in the committee has decreased in the past several years. As such, attendees discussed ideas on how to generate more interest in the TAC. It was agreed that there should be a special Task Group to address fastener issues and to assist the Criteria Council and A2LA Staff in drafting FQA-related documents.

Lou Dixon presented an update on the activities of the NACLA (National Cooperation for Laboratory Accreditation). He explained that NACLA is intended to provide a means of evaluating laboratory accreditation bodies. He provided the web site address for more information: http://ts.nist.gov/ts/htdocs/210/nacla/index.htm

The MAC met on June 1. Mr. Tom Smith reported on the purpose of the newly formed National Association for Proficiency Testing (NAPT). This non-profit organization is conducting proficiency testing for calibration laboratories. Several artifacts are already in circulation. For more information on the organization, please visit the NAPT web site at www.proficiency.org.

Interpretation to Section 12.1 of ISO/IEC Guide 25 and the revisions to the Draft Calibration Program Requirements were also discussed.

It has been agreed that both labs and assessors could benefit from a special guidance document on issues such as: traceability, measurement uncertainty, training, environmental conditions, records, what to look for in calibration certificates, what the difference is between measurement uncertainty, accuracy, and tolerance, and the criteria by which an in-house calibration lab can determine if it should seek accreditation. The task group assigned last year was reaffirmed and work on this document is now beginning.

We wish to offer our sincerest thanks to everyone who participated in this year’s activities. The high level of technical expertise and professionalism exhibited by the many individuals who attended the meetings was indeed impressive.

It has come to the attention of A2LA that NIST recently asked automotive and fastener industry executives for written feedback on their FQA concerns, including laboratory accreditation concerns.

A2LA would appreciate being copied on any of the letters that reference A2LA so that our Quality Manager can review them as part of our continuous quality improvement process.

Section 13.2.l of ISO/IEC Guide 25-1990 requires that calibration certificates contain “a statement of the estimated uncertainty of the calibration … result.” This requirement has been amplified somewhat in EAL-R1, “Requirements Concerning Certificates Issued by Accredited Calibration Laboratories”, such that any certificate issued by an accredited calibration laboratory shall contain “the measurement results and associated uncertainty of measurement and/or a statement of compliance with an identified meteorological specification.”

Considerable confusion has arisen amongst testing laboratories, as well as amongst some assessors and auditors, concerning exactly what is a “statement of the estimated uncertainty.” References to “4:1 TURs” have become particular sources of confusion.

It is A2LA’s position that a test uncertainty ratio is, in fact, a statement of the estimated uncertainty of a calibration. A2LA interprets this ratio to mean that the total uncertainty of the measurement system (as opposed to a simple combination of the uncertainties of the reference standards) does not exceed a given fraction of the specified tolerance. Common ratios include 4:1, 3:1, and 10:1, which indicate respectively that the total uncertainty of the calibration does not exceed one-fourth, one-third, or one-tenth of the specified tolerance. Thus, if a given calibration was performed under conditions which ensure that the TUR of the calibration is at least 4:1 with respect to a given tolerance, then the actual measurement uncertainty of that calibration is at most one-fourth of that tolerance.

Although A2LA has accepted the use of TUR statements by its accredited calibration laboratories on their accredited calibration certificates, there are a few caveats concerning its use. If the accredited calibration laboratory has been asked by its customer to provide the actual measurement uncertainty of a given calibration, then the accredited calibration laboratory must provide the actual measurement uncertainty.

In addition, the calibration laboratory must ensure that its measurement uncertainty for a given calibration really does meet the claimed TUR. An easy way for the customer to check if the actual measurement uncertainty can reasonably be said to be a certain fraction of the tolerance as claimed on a calibration certificate is for the customer to divide the tolerance being tested against by 4 (in the case of a 4:1 TUR) and to compare that quotient to the calibration laboratory’s accredited Best Uncertainty as found on the Scope of Accreditation. If the quotient is smaller than the accredited Best Uncertainty, then the accredited calibration laboratory has misstated its uncertainty for that calibration.

The argument can be made that for a testing laboratory to determine the uncertainty of its test results, it must know the uncertainties associated with its testing equipment. While this is true in some cases, in many other cases it is not true. For many testing labs it suffices to know that a piece of testing or measuring equipment has been found to be within specified tolerances. For example, a plastics laboratory performing melt flow rate determinations really has no need to know the actual uncertainty associated with every component of the melt indexer such as the bore and orifice diameter, uncertainty of the weights of the mass and piston, and the uncertainty of the bore temperature. It is sufficient for the testing laboratory in this case to know that each of the components of the melt indexer has been verified to be within the tolerances specified by ASTM D1238. This is one example in one field of testing- there are many other examples of tests wherein knowing the uncertainties of the components of the testing machine is of no use in determining the uncertainty of a test result.

So, when an assessor is trying to determine if a calibration certificate contains the information needed by the testing laboratory, the assessor must go beyond simply looking for a stated measurement uncertainty. Depending on the nature of the testing equipment, a simple TUR statement may suffice, or it may be sufficient to state simply that a piece of testing equipment has been found to be within the specified tolerances. In other cases, an actual measurement uncertainty must be provided; this is especially true if the accredited calibration laboratory is providing calibrations for another calibration laboratory.

Due to the additional staff time it takes to verify the addition of test methods to a scope of accreditation and the extraordinary paperwork involved for the FQA, the A2LA Board of Directors has approved charging FQA applicants $100 for more than one scope revision request per year. Requests to change the following information may be made without an additional charge:

The continued growth of A2LA has resulted in the addition of staff and some realignment of responsibilities. Following is a current listing of field managers and their primary areas of responsibility. If you have any questions related to a specific field of testing, please contact the appropriate staff member at their extension listed below, or Warren Merkel, Operations Manager, at extension 204.

Name	Title	Extension	Fields/Testing Areas
Teresa Adams	Sr. Laboratory Services Officer	202	Environmental, Biological, Chemical, Food
Thomas Adams	Laboratory Services Officer	219	Calibration, Dimensional Inspection, Mechanical, Chemical, Plastics, Rubber
Jacqueline Amokomowo	Laboratory Services Officer	206	Metals/Fasteners – Chemical & Mechanical
Ronald Bell	Laboratory Services Officer	203	Construction Materials, Geotechnical, Nondestructive, Chemical (Coal)
Cherie Beno	Laboratory Services Officer	220	Animal Drug Testing, Biological, Chemical, Environmental, Mechanical, Registration
Atefeh Fathi	Laboratory Services Officer	210	Proficiency Testing
Bethany Hackett	Laboratory Services Officer	227	Metals/Fasteners - Mechanical, Chemical, Plastics, Rubber
Janneth Ignacio	Sr. Laboratory Services Officer	207	Metals/Fasteners – Chemical , Mechanical
Trace McInturff	Sr. Laboratory Services Officer	223	Electrical, EMC, Chemical, Mechanical (Automotive), Thermal, Acoustics & Vibration
Steve Medellin	Laboratory Services Officer	228	Mechanical, Chemical (Automotive)
Mary Murphy	Laboratory Services Officer	229	Metals/Fasteners – Mechanical
Sara Weitzel	Laboratory Services Officer	224	Mechanical, Chemical, Plastics, Rubber, Textiles, Metals/Fasteners

The Board of Directors (BOD) of A2LA met on Monday, June 1 for committee meetings. The full BOD then met on Tuesday June 2. Several of the BOD’s major accomplishments are listed below:

A2LA has recently finalized specific program requirements for laboratories performing food microbiology and food chemistry analyses. Both documents encompass the Food Laboratory Accreditation Working Group (FLAWG) documents “United States Accreditation Criteria for Laboratories Performing Food Microbiological/Chemical Testing”.

These specific criteria relate to laboratories performing microbiological and chemical analyses in the examination of food products, ingredients in the production of food, in-process food samples, environmental samples pertinent to foods and final products. The criteria were developed to meet the needs of the United States Department of Agriculture (USDA) and are applicable to those testing laboratories seeking to meet USDA requirements for food testing under the A2LA Biological and/or Chemical Fields of Testing. Both documents apply to testing performed by methods that are nationally recognized as well as newly developed methods and laboratory developed methods. They are also applicable to all types of laboratories, whether they are in the private (independent or in-house) or government sector.

At this time, accreditation to these additional requirements is optional for food testing laboratories. However, those laboratories that are found to be compliant with the criteria are issued Scopes of Accreditation that specifically state that they have been found to meet these requirements in full.

For additional information regarding the A2LA Food Chemistry and Food Microbiology Programs, please contact Teresa Adams at extension 202.

As a result of the revisions to the FQA regulations (published in the April 14, 1998 Federal Register, can be viewed on the NIST FQA web page) and discussions during the assessor conclave, the A2LA Fastener Program Requirements are being revised. Once revisions are completed and approved by the A2LA Criteria Council, copies will be forwarded to fastener assessors, enrolled and accredited testing laboratories, Accreditation Council members, and A2LA Staff.

The corresponding assessor checklist will be modified accordingly, and provided to laboratories and assessors to be used in subsequent laboratory assessments. It should be noted that there are no major additions to the requirements. Rather, the test report requirement for name and affiliation of person performing lot sampling has been removed. Notes are being added to give guidance in interpretation of the requirements and to clarify A2LA policies.

After 3 years of significant contributions, Mr. Gurmit Singh, A2LA’s Staff Accountant will depart on July 16th and will be taking on new challenges. Gurmit has been instrumental in developing the accounting and financial services department at A2LA. For the past few years, he has been mainly involved in processing the final billings for the laboratories after the assessment/audit has taken place. With that exposure he has been in communication with many of the laboratories and certainly many A2LA assessors. Gurmit has also been instrumental in bringing payroll services, accounting functions and reporting in-house. These were great accomplishments for a small financial services staff.

He has also streamlined the accounts payable process and the annual review and renewal billing process with the able assistance of Ms. Marie Wright.

We would like to take this opportunity to wish Gurmit the best in his new venture.

Implementation of the FQA has been postponed another 90 days, until October 25, 1998. Please be sure to check http://www.nist.gov/fqa regularly for updates about the Fastener Quality Act (FQA) and its implementation (per June 30, 1998 Federal Register). The web site now also lists questions and answers from the 1996-1997 Public Law Workshops. Additional information is also posted under “FQA Facts.” A2LA-accredited laboratories are being submitted in batches and posted to the web page listing of FQA accredited laboratories, typically on Thursdays.

NIST held a Hardness Standardization Workshop on June 29-30, 1998, coordinated by Samuel Low, Chairman of the ASTM E28.06.07 - Task Group on Traceable Hardness Standards (NIST). Of note is the availability of NIST-traceable Rockwell Hardness (C scale) block SRMs (Standard Reference Materials). NIST is working on developing traceable hardness blocks for other Rockwell scales over the next several years.

Consequently, revisions to ASTM E18 are being proposed by ASTM Subcommittee E28.06 on Hardness. These proposed changes will be discussed during the ASTM E28 meetings in Norfolk, VA in November, 1998, and include a requirement that hardness calibrations be done by ISO/IEC Guide 25 accredited laboratories.

Martin Mitchell of Certified Laboratories, Inc., Plainview, NY has been a member of the A2LA Board of Directors since January 1, 1997. The 1997 A2LA Annual Report failed to include Mr. Mitchell in the listing for the 1997 Board of Directors. We regret this oversight and apologize to Mr. Mitchell for any inconvenience this omission may have caused.


Peter Unger presents honorary lifetime membership to former President John Locke.	Board Chairman Steve Bowser addresses attendees of A2LA 20th Anniversary Dinner.


President Peter Unger presents honorary lifetime membership to Les Huntley.	Joe O'Neil, ACIL Executive Director, addresses A2LA dinner attendees.

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