Agenda of the Board of Directors/NTEP Committee

Dennis Ehrhart, CPM

Assistant Director, Compliance

Arizona Department of Weights & Measures

# Introduction

The Board will hold their quarterly Board of Directors meeting on
Saturday, January 24, 2004, and continue that meeting during work
periods throughout the remainder of the Interim Meetings. Except when
posted, all meetings are open to the membership. The Board of Directors
and NTEP Committee will hold open hearings at the Interim Meeting and
members will be invited to dialogue with the Board on issues that the
Board and NTEP Committee have on their agenda. The Board of Directors is
currently working on the following issues: Conformity Assessment, NCWM
Organizational Structure, the National Training Program, Voting
Procedures, Public Relations campaign and participation internationally,
i.e., OIML, CFTM, APLMF, and U.S. NWG.

**Table A**

**Table of Contents**

**Subject**

[Introduction 1](#introduction)

[1. Conformity Assessment 2](#conformity-assessment)

[2. NCWM Organizational Structure 2](#ncwm-organizational-structure)

[3. National Training Program Curriculum
2](#national-training-program-curriculum)

[4. Voting Procedures 2](#voting-procedures)

[5. Public Relations Campaign 3](#public-relations-campaign)

[6. NCWM Participation in International Standards Setting Activities
3](#ncwm-participation-in-international-standards-setting-activities)

**Table B**

**Appendices**

[**Appendix A. Publication 14, Administrative Procedures, Section S
5**](#AppendixA)

[**Appendix B. Article from NCWM -- NEWS, 2003,**](#AppendixB)

[**CONFORMITY ASSESSMENT: We continue on** **8**](#AppendixB)

[**Appendix C. Report on the Activities of the International
Organization of Legal Metrology (OIML)**](#AppendixC)

[**and Regional Legal Metrology Organizations 15**](#AppendixC)

[Appendix D. Harmonization with OIML: What It Means and How It Will
Happen 21](#AppendixD)

**Monday, January 26**

8:30 a.m. - 5:00 p.m.

During the Board of Directors/NTEP Committee's Open Hearing, the
membership is invited to provide feedback on the following issues:

# 1. Conformity Assessment

At the October 2003 NCWM Board Meeting, the Board discussed the current
status of the NTEP Conformity Assessment Program. The Board agreed that
it needs to move forward on this item and begin to formulate the details
that will make up each section of the program. Steve Patoray was
directed to draft a final version of NCWM Publication 14, Administrative
Policy, Section S. *Conformity Assessment.* The final draft can be found
in Appendix A. Explanatory information is included in Appendix B.

The Board also agreed that three work groups would be formed to complete
the needed work to document the details of each of the three sections of
the Program, Initial Verification, Administrative Review, and Verified
Conformity Assessment Program (VCAP). Dennis Ehrhart will be identifying
and contacting individuals to Chair each of these work groups.

Ross Andersen has prepared a brief presentation on Conformity Assessment
Program with the intent to answer some of your questions and stimulate
input from the NCWM members.

# 2. NCWM Organizational Structure

The Board has been examining the current Standing Committee structure.
Recognizing that the members of the S & T and L & R Committees cannot be
expected to be experts on all issues that come before those committees,
the Board has been discussing the use of Ad Hoc Advisory Task Forces
that would work on particular technical issues, reporting back to the
Standing Committee.

# 3. National Training Program Curriculum

> The Board has charged the Professional Development Committee (PDC)
> with developing a process to determine the curriculum for a training
> program. Please see the PDC agenda for the detailed description of the
> responsibilities that the Board has defined as the primary
> responsibilities of the PDC regarding the National Training Program
> Curriculum.

# 4. Voting Procedures

> The Board is evaluating the current Bylaws requirements concerning the
> voting procedures at the annual meeting. At issue is the current
> requirement of 27 votes to pass or defeat an item. The Board will take
> comments from the membership concerning this very important issue. The
> BOD has discussed the concerns heard at the meeting in Sparks, NV,
> about the voting procedure and the corresponding number of votes
> required to pass or fail an item.
>
> The Board will consider the following proposal from the Central
> Weights and Measures Association. It alters the number of votes
> required based on the number of state representatives in attendance.
> The intent is to provide reasonable assurance that, had the number of
> representatives voting been greater, the same action would have
> resulted. It does not alter the rules for a quorum as found in Article
> X, Section 5.
>
> **Proposal:** Modify the NCWM Bylaws, Article X, Section 4 - Minimum
> Votes as follows:
>
> **Section 4 - Minimum Votes**
>
> **A. House of State Representatives**
>
> [When at least 35 delegates are in attendance in the House of
> Representatives,]{.underline} ~~A~~ [a]{.underline} minimum of 27
> votes in favor of, or 27 votes in opposition to, an issue must be cast
> for the vote to be considered official. If 54 or more votes are cast
> in the House of State Representatives, a simple majority of the total
> votes is required to pass (or defeat) the issue.
>
> [When fewer than 35 jurisdictions are in attendance in the House of
> Representatives, a two-thirds majority of those Representatives in
> attendance of the conference voting in favor of, or in opposition to,
> an issue must be cast for the vote to be considered official. The
> rules for a Quorum in still apply.]{.underline}
>
> **B. House of Delegates**
>
> A minimum of 27 votes in favor of, or 27 votes in opposition to, an
> issue must be cast for the vote to be considered official. If more
> than 54 total votes are cast, a simple majority rules. Should a tie
> vote occur, or if the minimum votes in support or opposition are not
> cast, the issue is decided by the vote of the House of State
> Representatives.

# 5. Public Relations Campaign

The plan for a NCWM Public Relations Campaign that was drafted by DeeAnn
Deaton, Public Information Officer, Arizona Department of Weights and
Measures, will be presented. Comments and suggestions will be welcomed
to finalize a draft for the Annual Meeting in Pittsburgh, PA. The
objectives of that plan are to:

-   Increase overall awareness of the NCWM;

-   Increase the total number of citizens who act as the \"eyes\" of
    weights and measures agencies;

-   Increase industry compliance; and

-   Increase funding support of both legislators and voters for weights
    and measures programs.

# 6. NCWM Participation in International Standards Setting Activities

Along with Craig VanBuren, incoming S&T Chairman, Dennis Ehrhart
attended the Canadian Forum on Trade Measurement in Calgary, Alberta,
November 19 and 20. A report will be made on the activities that took
place during that meeting. Ross Andersen will also report on his
participation at the APLMF meeting. Please see Appendix C for the NIST
report on OIML and Appendix D for background information of the effort
to harmonize U.S. weights and measures requirements with those of OIML.

**Tuesday, January 27**

8:30 a.m. - 12:00 noon

Board of Directors/NTEP Committee Opening Hearing

During this portion of the Board of Directors/NTEP Committee's open
hearings, the Board invites the membership to an open forum where
members can ask questions and provide feedback to the Board.

1:00 p.m. - 5:00 p.m.

Working session.

D. Ehrhart, Arizona, Chairman

R. Andersen, New York, Chairman of the NTEP Committee

D. Frieders, San Francisco, California, Chairman-Elect

T. Geiler, Barnstable, Massachusetts, Treasurer

M. Cleary, California

D. Onwiler, Nebraska

B. McGrath, Boston, Massachusetts

K. Angell, West Virginia

S. Pahl, Texas

C. Guay, Procter & Gamble Co.

D. Quinn, Fairbanks Scales

Executive Secretary: H. Oppermann (NIST)

Advisors: B. Palys, Executive Director, NCWM Headquarters

G. Vinet, Canada

**Board of Directors**

[]{#AppendixA .anchor}**Appendix A**

**Publication 14, Administrative Procedures, Section S**

**FINAL DRAFT Nov. 6, 2003**

**Definition:** Anytime the term [manufacturer]{.underline} is used it
refers to not only the Original Equipment Manufacturer but also to any
type of re-manufacture or re-manufacturer of a device. (This will be
located in the definition Section of this Publication)

**S. Conformity Assessment**

Type approval (certification) is one of the main elements in the
metrological control system for weighing and measuring devices used in
commercial measurements. The NTEP Certificate of Conformance, issued by
NCWM, is a tool used by weights and measures officials in the inspection
and approval of those devices. NTEP looks at one or more devices in a
family, during the evaluation process. This typically occurs in the
early stages of product development or production, yet it is expected
that a commercial device will have a useful production life of several
years. It is inevitable that changes will occur in production methods or
components, that new features will be added to improve the product to
respond to user needs and that the technical and performance standards
will change as *NIST Handbook 44* evolves in its annual cycle. Some of
these changes will result in the manufacturer requesting a reevaluation.
The content and format of a Certificate of Conformance will also evolve
over time.

It is vital that the Certificate of Conformance accurately reflects the
device design and its features. It is also vital that the device be
manufactured in conformance with the applicable requirements, while the
Certificate of Conformance is in active status. In addition to the type
evaluation, described in Section E. through G. of this document, the
steps below outline the measures NTEP will use to keep the Certificate
of Conformance accurate and to ensure conformance.

> **S.1 Main Elements**
>
> **S.1.1 Initial Verification:**
>
> Initial Verification is the first official test of a commercial
> weighing and measuring device by a weights and measures official. It
> is another element in the metrological control system. These tests
> offer an invaluable means to check production devices and many, but
> not all, of their features against the current requirements of *NIST
> Handbook 44* and to verify the information provided in the NTEP
> Certificate of Conformance is both accurate and correct. The
> information gathered by the states during Initial Verification will be
> used to provide feedback to NTEP. NTEP will use this information to
> assist in the process of verifying that production devices remain in
> compliance and that the information on the NTEP Certificate of
> Conformance remains accurate.
>
> **S.1.2 Administrative Review of an NTEP Certificate of Conformance:**
>
> The Administrative Review of all NTEP Certificates of Conformance will
> be periodically conducted by NTEP. This review will help to ensure
> that:

-   The NTEP Certificate of Conformance accurately reflects current
    Metrological Characteristics of the device as well as Standard
    Features and Options.

-   The type remains in compliance with all current *NIST Handbook 44*
    requirements, including those requirements amended after the issue
    date of the Certificate. NTEP will consider information provided by
    the Certificate holder in the application and information provided
    by the States based on Initial Verifications.

-   The NTEP Certificate of Conformance is updated periodically to
    provide information consistent with current practices of NTEP.

> *NOTE: During the phase in period NTEP will use special procedures to
> establish the review date for Certificates issued prior to the
> implementation of this Conformity Assessment policy. After this phase
> in period, the Administrative Review of current active NTEP
> Certificate would be an ongoing process relying on feedback received
> from the initial verification and VCAP.*
>
> The certificate holder will be notified and shall apply to NTEP for
> review on or before the Review Date in a format designated by NTEP.
>
> **S.1.3 Verified Conformity Assessment Program (VCAP)**
>
> Many NTEP Certified devices must meet NIST Handbook 44 requirements
> for Influence Factors. It is not possible to verify these requirements
> during the Initial Verification in the field. Therefore, manufacturers
> of metrological devices (instruments) and/or components (modules)
> which are subject to Influence Factors, as defined in NIST Handbook
> 44, must have a Verified Conformity Assessment Program (VCAP) in place
> to ensure that these metrological devices (instruments) and/or
> components (modules) are produced to perform at a level consistent
> with that of the device and/or component previously certified. A
> second or third party audit must verify the Conformity Assessment
> Program. The second or third party must be a Certified Registrar
> accredited for appropriate instruments.
>
> The Conformity Assessment Program verification will be site-specific
> and will focus on the site that controls the design, manufacture,
> quality, and testing of the device.
>
> For weighing devices that are subject to influence factors, NTEP will
> require an initial on-site audit of the manufacturers\' quality system
> and (on-site) random testing and/or review of a production device(s)
> (instrument(s)) by the Registrar to verify that all items listed below
> are currently implemented and functioning to verify compliance to the
> appropriate sections of NIST Handbook 44:

1.  Load Cell (T.N.8.)

2.  Indicating elements (T.N.8.)

3.  Weighing/Load Receiving elements with [non-NTEP]{.underline} load
    cells (T.N.8.)

4.  Complete Scales (T.N.8.)

5.  Automatic Weighing Systems (T.7.)

6.  Belt-Conveyor Scales (T.3)

7.  Automatic Bulk Weighing Systems (T.7.)

> **a. The Manufacturer has:**

1.  A documented Quality Management system governing the design and
    manufacture of the device.

2.  Appropriate production and testing facilities and equipment

3.  Identified the applicable Metrologically Significant Components
    (MSC's) of the device.

4.  Appropriate statistical methods implemented to ensure that the
    process is in control

5.  An appropriate sampling plan, and acceptance criteria in place and
    operating

6.  Required operator\'s manuals and calibration procedures for all
    appropriate production and testing equipment

7.  A Nonconforming Material system to control nonconforming /
    non-compliant devices and components (either manufactured or
    purchased).

8.  Adequate control over Subcontractors and sub-tier suppliers

9.  Appropriate Corrective Action system to deal with nonconforming /
    non-compliant devices

10. An Engineering Change system to control engineering/design changes
    affecting any MSC's.

11. A Document and Data Control (including software and firmware) system
    to control changes affecting and MSC's.

12. A Production Control system to control changes affecting any MSC's.

13. An Identification and Traceability system (including serialization
    and lot/batch control as applicable) applied, as a minimum, to
    MSC's.

14. Documentation that personnel have been properly trained.

> **b.** If the manufacturer contracts with an outside laboratory to
> conduct the Influence Factor testing, that laboratory will be subject
> to all pertinent Conformity Assessment Program requirements.
>
> **c.** A subsequent audit report provided by the Registrar, at least
> every five years, verifying an on-site visit to the manufacturing
> facility to review the statistical quality assurance and production
> records for all affected certified devices, and random testing or
> review of a production device in the manufacturing facility.
>
> []{.mark}
>
> **d.** Information may be request from manufacturer in between the
> scheduled audits.
>
> **S.2 Consequences**
>
> If a Certificate holder fails to submit an application for the
> Administrative Review, when requested, by the review date specified,
> the NTEP Certificate of Conformance will become inactive.
>
> If a Certificate holder of a device subject to influence factors fails
> to submit documentation, by the required date, indicating that it has
> and continues to maintain a Verified Conformity Assessment Program
> (VCAP) for influence factors, the NTEP Certificate of Conformance will
> become inactive.

[]{#AppendixB .anchor}Appendix B

Article from NCWM -- NEWS, 2003

CONFORMITY ASSESSMENT: We continue on

Stephen Patoray

We have just completed a really great time at the Annual meeting. There
was a lot of work done leading up to this meeting as well as a lot of
comments on all types of subjects during the meeting. Most of the items
up for vote passed and will become part of the respective Handbook
Codes. The topic however, that was of most interest to many folks at the
Conference was Conformity Assessment. There was significant discussion
in the NCWM Board meetings. There were also both comments and questions
from the NCWM members from the floor during the open sessions and during
other times at the meeting. Some of these comments were positive and
some were not. Some of the questions were very thought provoking and
expressed concern over the need and intentions of certain parts of the
Conformity Assessment Program or the Program as a whole. It is the
intention of this article to try to answer some of these questions so
that we can all move forward with the Conformity Assessment Program.
Just to clarify, this article is a [commentary]{.underline} by me on
various areas of NTEP and Conformity Assessment. It is meant to be
informative, and is based on my observations and thoughts as an outcome
of the discussions at the Annual meeting. The NCWM Board will ultimately
decide any changes to the proposed Conformity Assessment Program policy.

I would like to start out with going back and reviewing some history. So
it is clear, I am using as references for this article, several
documents, both published and non-published. Some of these include the
\"National Conference on Weights and Measures Publication #8, Scale
Manufacturers Association (SMA) \"Metrology Control Plan (MCP) - 1999
rev.\", several volumes of the NCWM Annual report and several
non-published documents from various members of NCWM.

The United States is unique in many ways, Weights and Measures is
another example of this uniqueness. Unlike most industrialized countries
in the world, the United States does not have a federalized legal
metrology system. The [States]{.underline}, via the Weights and Measures
Law adopted and in force in that State, govern the regulation of
weighing and measuring devices used in commerce. However, like Canada,
the United Kingdom, Germany, Australia and many others, we do have a
similar approach to legal metrological control, these are type
evaluation/certification, initial verification and subsequent
verification.

The concept of pattern approval or Type Evaluation, as it is better
known in the US, is not a new idea. Back in the late 1960\'s, the then
National Bureau of Standards began issuing \"Reports of Test\". Also,
many States had set up laboratories and required devices to be evaluated
and certified before they could be placed in service within that state.
In some cases, states would recognize the certificates issued by other
states. In all, there were at least 15 different possible certificates
that a company might be required to obtain before they could install
devices in all the various states in the US. Then in the mid 1970\'s
work began on a National Type Evaluation Program. By the mid 1980\'s,
this program was finally adopted by the NCWM and the states began
recognizing the NTEP Certificates of Conformance that were at that time
issued by NIST.

\"Type evaluation was put forward and has been supported by the scale
industry on the basis of 3 principles: (1) to give manufacturers
assurance that the engineering and operational features of a prototype
device would be acceptable in advance of a hard tooling production
decision; (2) to provide device manufacturers a single approval process
which would be recognized by all jurisdictions; and (3) to shelter the
subsequent verification subsystem from excessive failure incidents. At
no time was it suggested by industry that type evaluation should assume
any exceptional responsibility for or supersede the subsequent
verification role in field enforcement. The initial verification
function serves as the first line of defense with respect to production
meeting type. Field failures further along the life cycle line can be
expected to be more related to field variables than conformance to type.
However, production changes relatively late in a product's life cycle
can still affect performance and compliance. These events should be
evident from field data failure reports.\" SMA MCP 1999

The concepts put forward in the SMA MCP include a Product Life Cycle.
This life cycle is described as:

> \"A product is conceived by a Manufacturer and is designed to the
> standards of the Manufacturer and within the requirements set forth by
> the NCWM. Once the product has reached a certain level of development,
> a prototype or pre-production sample of the product is submitted for
> type evaluation to an NTEP-assigned Testing Laboratory, which
> evaluates the product to the standards developed by the NCWM. Once the
> product is shown to meet these requirements, the Manufacturer begins
> to place the product in applications, which are considered "Legal for
> Trade." As each unit is "placed in service" an initial verification
> test is performed by an official having statutory authority. From this
> point forward the product may experience a variety of changes or
> interruption in its service life. These changes involve such things as
> adding additional hardware with the intent of enhancing the process;
> to using the product for an operation which was not known when
> originally installed and may be performed by the end user without the
> original manufacturer knowledge or consent. An interruption may be the
> result of a product failure and may be corrected by the Manufacturer,
> User, or Third Party capable of performing the necessary service, but
> in all cases will be subjected to subsequent verification.\" SMA MCP
> 1999
>
> I have presented this background information to show that all during
> the conception of NTEP, the role of type evaluation and initial
> verification were very closely linked. Each significant part of the
> product life cycle is under the control of a different responsible
> party. The Concept and Design phase is the responsibility of the
> manufacturer. The type evaluation is the responsibility of NTEP. The
> initial and subsequent verification is the responsibility of the State
> or local jurisdiction. The reporting of metrologically significant
> changes to the device is the responsibility of the manufacturer. And
> the cycle continues.
>
> \"As with any process which is intended to produce measured results,
> the sharing of data collected, at all stages of the process, is the
> key to its success. This data may be the result of testing performed
> by the manufacturer during the products design and initial field
> tests; from the laboratory testing for pattern approval (by NTEP) and
> both the initial and subsequent verification testing (by the States).
> If we look at each of the responsible parties, each one plays a major
> role in the checking and balancing of the process.\" SMA MCP 1999

I think this background provides some useful information on the role of
NTEP and type evaluation. From my perspective, NTEP has proven to be a
most useful tool for the States, the Consumer and the Manufacturer to
ensure that a device type has the capability of meeting the requirements
set forth in NIST Handbook 44. Type evaluation under NTEP also serves to
provide some relief from excessive failures in the initial and
subsequent verification of a device. So now, let\'s take a closer look
at Conformity Assessment as discussed at the recent NCWM Annual meeting.

**Question:** Why do we need Conformity Assessment?

**Answer:** We need conformity assessment to ensure that devices
produced [after]{.underline} the device has been type evaluated and
certified by NTEP continue to meet the same requirements.

**Question:** How can this be accomplished?

**Answer:** The States can best accomplish this for most devices and
requirements through initial verification.

**Question:** What is initial verification?

**Answer:** Initial verification is conducted on a new installation of a
legal for trade device by the State or local jurisdiction within the
first 30 days after the device is put in service. The time is limited to
the first 30 days due to the fact that during this time, the device is
required to meet acceptance tolerance, after 30days maintenance
tolerances are required. This verification has two parts, one is
inspection and the other is performance testing.

**Question**: Can you explain the difference between inspection and
performance testing?

**Answer:** The inspection portion of initial verification includes a
review of the device for markings, that the NTEP CC accurately describes
the features and options seen on the device being verified at this
installation, that an active NTEP CC or multiple CC\'s cover(s) the
various metrologically significant elements of the system, and that the
various elements are compatible and appropriate for the installation.
The performance testing is as it sounds, actually testing the device
with known standards to determine that the device meets all of the
performance standards of NIST HB 44.

**Question:** But what about influence factors, such as T.N.8. in the HB
44 scales code?

**Answer:** Influence factors cannot be evaluated in the field. They
must be evaluated under controlled conditions.

With some of this basic knowledge, let\'s now discuss the three elements
of the proposed Conformity Assessment Program. As they were listed in
the proposed Administrative Policy, they were:

Initial verification

Administrative review

Verified Conformity Assessment Program (VCAP)

Lets go through these items one at a time. Please note that what follows
are my own comments, and in some cases they may differ from what was
described in the proposed policy seen in the most recent NCWM Newsletter
and discussed at the July 2003 Annual meeting. This is mainly due to
hearing the comments and questions at the Annual meeting. I really did
attempt to listen to what was being said. All of what follows will need
to be reviewed by the Work Group as they begin to work on the details
and they may be changed. Also, the NCWM Board has final approval of any
proposed changes to the policy.

**Initial Verification**

Initial verification was discussed earlier as one of the major
components of the SMA Metrology Control Plan. It is key to fulfilling
the need to know that subsequently produced devices are \"the same\" as
the device that was evaluated. In simple terms, it provides
surveillance. I think it is fair to say that just about everyone agrees
that initial verification is the most practical and most cost effective
method to attempt to understand that subsequent production devices
continue to meet the same standards as the ones that were initially
Certified. There were a number of very good questions on just how this
would be accomplished. Some of those questions were:

What are the details of this area? How can you determine if there is a
problem if you do not take into account the entire population? How will
the information be collected, verified, stored, shared? Why be concerned
if the problems are resolved at initial verification? Will there be
training for the initial verification inspectors? Where will the time
and money come from to accomplish this? These are all very good
questions that need to be answered. I am not certain that I have all of
the answers, but here is an attempt to answer at least some of these.

First, it is my understanding that initial verification is something
that is going on in most state and local jurisdictions right now. In
many jurisdictions, it is the law that a state or local inspector
accomplishes this within a set period of time. There are however,
significant variations in what is currently taking place in each of the
various state or local jurisdictions. With the current budget shortfalls
in most states, resources are being stretched. It is also very important
that the data received by NTEP is good data. What could be proposed is a
pilot program that focuses on one device type. States could choose to
volunteer and sign up to be part of this pilot program. With this small
controlled group of inspectors, the details of gathering the data, what
data needs to be gathered, how the data is presented and how the data is
analyzed could be worked out. From this core group, the program could
then take on controlled growth into other states and other device types.
These smaller steps would allow NTEP, the states and the CC holders to
gain understanding and confidence in the initial verification process
and its expanded role of a surveillance tool of NTEP. It would also
allow for a controlled growth of the database needed to handle the
potentially large amount of data. This pilot program would also allow
for a review of the benefits of gathering the initial verification data.
If there is no benefit shown, then Conformity Assessment could be
modified. If however, the benefit shown is great, more effort and
resources could be channeled in to this area to include more devices and
more states. In this case, let the data tell us where we need to be
going. If problems were found with certain devices, it would be a joint
effort of state jurisdictions, NTEP and the CC holder to resolve those
problems. The more difficult question to answer is when is there a
problem? What are the trigger points? Or to put it into Statistical
Process Control Language (SPC), is the process \"out of control? Without
a good knowledge of the field population or some way to determine a
percent failure, this will be difficult. And to be honest, I do not have
an answer to this issue. But I am certain that with all the great minds
out there in the Conference that someone or some group will come up with
an elegant solution.

Any data that is in the control of NTEP will always be treated as
confidential. It would be considered part of the evaluation of the
device and would not be shared with anyone other than the CC holder,
unless written permission is obtained. Currently states are gathering
this initial verification data. I would expect that each state handles
this data a little differently.

With initial verification we still have some questions that need answers
and some details to define to complete the whole process. But this is
what the work group will be doing very soon. And I feel that with a
pilot program we can obtain those answers and make the right decisions.

**Administrative Review**

I have spent a lot of time thinking about the questions and comments
made at the Annual regarding the Administrative Review. I think that
most of the questions can be summarized as:

**Question:** If you have a good initial verification program, why do
you need a 10-year Administrative Review on a CC?

**Answer:** You probably don\'t.

**Question:** Then why do you need an Administrative Review at all?

**Answer:** All NTEP CC\'s need to be made both accurate and current.

NTEP has been issuing CC\'s since 1985. This has been an evolving
process. Over that time, numerous people have drafted and reviewed
CC\'s. Knowledge was gained and lost on what important information was
needed on a CC. Requirements of HB 44 have changed. The criteria in
Pub14 have changed. New devices and a changing list of device types have
made their way on to NTEP CC\'s. Working with the CC\'s everyday as I
do, I see the significant variations in the content of an NTEP CC. Quite
frankly, some CC\'s are written much better than others. Unfortunately,
there is no detailed standard for the content of an NTEP CC. A
well-written CC with the correct information is vital to the success of
the initial verification on a device. We need to have a standard format
that CC\'s of each device type follows. The information should be clear,
concise, and readily understood.

After rethinking this whole issue and trying to answer the question,
\"what are we trying to fix?\" I would propose that there is still the
need for an administrative review on all NTEP CC\'s. In keeping with the
proposal for initial verification to begin with a pilot of a specific
device type, I would propose that the administrative review also be
started as a pilot with the same device type. With this, all CC\'s of
the chosen device would be reviewed at the same time. They would all be
brought to the same standard. Then as we move forward, any new CC would
be drafted using that same standard. The updated CC\'s would then be a
useful tool for the inspectors during initial verification. With this
information, any changes or problems found during initial verification
would be handled at that time. There would be no need for a review date
of ten years or five years in the future. The problem would be fixed and
we would move forward with a better CC and a better program. The playing
field would be a bit more level.

**Question:** What is an Administrative review?

**Answer:** A review of the NTEP CC, not an evaluation of the device.

**Question:** Would I have to submit an actual device for testing?

**Answer:** NO! The only case for actual submission of a device would be
if it were found that metrologically significant changes had occurred to
the device since the last laboratory evaluation.

**Question:** Well then, what will I have to do?

**Answer:** The details of this will need to be worked out by the work
group on this topic. But here are a few thoughts to get the conversation
started.

A major item that needs completion is to have a standard set of criteria
for the content of a CC for each device type. With this set of criteria
a CC can be reviewed for completeness of information and formatting.
Also, the CC holder and NTEP would review the CC compared to the current
device\'s standard features and/or options, range of capacities,
accuracy, applications, etc. If the NTEP CC matches up with the current
device, then nothing more may need to be done in this area. The CC
holder would provide current product literature to include in the
current folder on this CC. Digital photos of the device might also be
required for the file. The CC holder would also provide a listing of
changes to the device from the time of the last NTEP evaluation due to
the changes in HB 44. In many cases, the CC \'s have been kept up to
date. And this review would not be a great burden for either the CC
holder or NTEP. The results of this review will be an accurate, clear
and consistent NTEP CC. The photos and literature are a benchmark for
the device. These would be in the file at NTEP and only be used to
resolve issues that may arise with initial verification. These photos
may or may not become a part of the NTEP CC.

**Question:** How much will this Administrative Review cost?

**Answer:** Any details relating to fee structure is a matter for the
NCWM Board to approve. Any fees however, would be the responsibility of
the NTEP CC holder. One possible method might be a nominal application
fee to cover the basic initial CC review by NTEP staff. Then the
remainder of the work would be on an hourly basis. If the NTEP CC and
the information supplied by the CC holder are complete and correct, then
both costs and time to NTEP would be minimal. The goal here is to keep
the costs for all involved at a minimum. We must keep our eyes on the
goal of having accurate, complete and consistent NTEP CC\'s to be used
for Initial Verification.

**Verified Conformity Assessment Program (VCAP)**

**Question:** What about this Verified Conformity Assessment Program
(VCAP), what is that?

**Answer:** The VCAP is to address the requirements in NIST HB 44 that
relate to influence factors. T.N.8 from the Scales code is the section
that is most familiar to people.

**Question:** What is so special about influence factors? I thought we
were doing an initial verification on all devices.

**Answer:** An initial verification in the field cannot test for
influence factors. These are things like performance changes over a
range of temperature. Changes due to barometric pressure, and changes
due to power fluctuations may also be evaluated.

**Question:** Why not do these in the field at initial verification?

**Answer:** NIST HB 44 states (2.20 Scales T.N.8. Influence Factors.)
that these tests must be conducted under controlled conditions. These
tests must be done in a lab.

**Question:** What types of devices need to meet influence factors?

**Answer:** Currently only Weighing Devices: Scales, load cells,
indicating elements, Automatic Bulk Weighing Systems, Automatic Weighing
Systems, Belt Conveyor Scales etc.

**Question:** So what are the CC holders of weighing devices going to
have to do to meet the VCAP requirement?

**Answer:** In very simple terms the VCAP will require an on-site audit
by a certified Registrar accredited for weighing and measuring
instruments. The audit criteria are fourteen items that are taken
generally from the ISO 9001-2000 guidelines for quality systems. These
fourteen items follow at the end of this section in Appendix A.

**Question:** Why not just use the ISO certification as evidence that
these devices meet type?

**Answer:** The requirements of ISO 9000 series are very broad in scope
and while they provided evidence that a quality system is in place and
that processes may be completed consistently, it does not require that
devices actually meet specific performance requirements of HB 44. The
requirements of VCAP are focused on only those aspects of the
manufacturing process related to meeting the influence factors for
weighing devices as described in NIST HB 44.

**Question:** So this is an audit in addition to any current ISO
auditing?

**Answer:** Yes

The VCAP will be site specific and will focus on the site that controls
the design, manufacture, quality and testing of the Certified device.

**Question:** What do you mean by site specific?

**Answer:** Site specific is a term used by VCAP to refer to one actual
site, whether that be a manufacturing facility or a laboratory, which
controls the various aspects related to influence factors for a single
device or for many devices. An example is a load cell manufacturer. The
manufacturer may hold many NTEP CC\'s on many types of load cells.
However, all of the load cells are manufactured, tested and compensated
at one manufacturing facility or site. This one site controls the
various aspects of all of the Certified devices. Only this one site
would need to be audited and certified, to cover all of the various
Certified devices. This is different from another manufacturer who may
manufacture devices or different types in various manufacturing
facilities; let\'s just say aluminum single point load cells at one
facility and stainless steel double end shear beams in another facility
in another part of the country. Each of the different sites that control
the various aspects of that particular certified device would need to be
audited and certified for the respective Certified devices that they
have control over.

**Question:** What if I have a separate laboratory conducting audits on
production samples?

**Answer:** This laboratory would be a part of an overall documented
Quality Management System governing design and manufacture of the
Certified Device. As such, it would need to be audited and certified for
the applicable requirements for the functions of the lab. Other
requirements would need to be audited and certified at the site that
actually controls these particular aspects of the Certified device.

The simple answer here is that each company operates their business as
best they can. There are differences in philosophies, size, number of
devices, and many other factors that come into play. It is the intent of
the VCAP program to verify that there is a quality management system,
equipment and process in place to ensure that devices being manufactured
and sold as NTEP Certified devices do indeed have the capability of
meeting the influence factor requirements of HB 44. The methods used to
achieve this will be varied from company to company. They may even vary
within a company. VCAP is not meant to be an obstacle for how a company
chooses to best operate.

**Question:** Will there be follow up visits by the auditor?

**Answer:** Yes currently that is proposed to be every five years

**Question**: What happens in between?

**Answer:** The current proposal is a self-audit conducted by the CC
holder. This audit would be based on an NTEP approved sampling plan
based on a recognized standard such as ANSI. The CC holder would keep
records of the various device audits and any required corrective action
that took place. The auditor at the follow up audit would review these
records.

**Question:** Will NTEP have a standard for the auditor to use? Who will
actually conduct this audit?

**Answer:** The answer to this question still lies in the work to be
completed by the work group. Different options have been discussed
regarding the details of exactly how this will be accomplished. NTEP
could possibly complete work on it own standard for VCAP and identify
specific auditors that would be certified to complete the audits. There
are also several certification programs that are currently operating
that are specific to weighing devices meeting the influence factor
requirements. One or all of these certification programs could be
recognized by NCWM as acceptable. I suggest we let the work group do its
job and then we all can discuss the results of that group when they
become available.

This topic received many comments at the Annual meeting. I think that it
is clear that there is general consensus that devices meeting influence
factor requirements is an important parameter and must be verified. I
will not pretend that I have all of the answers to the remaining
questions about the details of this program. But it is my commitment to
challenge the work group to come up with a proposal that will be tough,
but fair, in dealing with this issue. Once this is proposed, the NCWM
Board will be reviewing that proposal and will be seeking additional
input from all of you.

If you have any comments or questions regarding Conformity Assessment,
suggestions or how to improve the items discussed or any other
information, the NCWM Board and I would be very anxious to hear from
you.

**[Appendix. Subset of draft proposal discussed at the Annual meeting as
it relates to VCAP.]{.underline}**

For weighing devices that are subject to influence factors, NTEP will
require an initial on-site audit of the manufacturers\' quality system
and (on-site) random testing and/or review of a production device(s) by
the Registrar to verify that all items listed below are currently
implemented and functioning to verify compliance to the appropriate
sections of NIST Handbook 44:

**Weighing Devices:**

1.  [Load Cell (T.N.8.)]{.underline}

2.  [Indicating elements (T.N.8.)]{.underline}

3.  [Weighing/Load Receiving elements with non-NTEP load cells
    (T.N.8.)]{.underline}

4.  [Complete Scales (T.N.8.)]{.underline}

5.  [AWS (T.7.)]{.underline}

6.  [Belt-Conveyor (T.3)]{.underline}

7.  [ABWS (T.7.)]{.underline}

**[Required Items to verify]{.underline}**

a\. **The Manufacturer has: (*notes in parentheses are original item
numbers from Newsletter article.)***

1.  (Item 2) A documented Quality Management system governing the design
    and manufacture of the device.

2.  (Item 6) Appropriate production and testing facilities and equipment

3.  (Item 5) Identified the applicable Metrologically Significant
    Components (MSC's) of the device.

4.  (Item 4) Appropriate statistical methods implemented to ensure that
    the process is in control

5.  (Item 3) An appropriate sampling plan, and acceptance criteria in
    place and operating

6.  (Item 7) Required operator\'s manuals and calibration procedures for
    all appropriate production and testing equipment

7.  (New) [A Nonconforming Material system to control nonconforming /
    non- compliant devices and components (either manufactured or
    purchased).]{.underline}

8.  (Item 9) Adequate control over Subcontractors and sub-tier suppliers

9.  (Item 8) Appropriate Corrective Action system to deal with
    nonconforming / non-compliant devices

10. (New) [An Engineering Change system to control engineering/design
    changes affecting any MSC's.]{.underline}

11. (New) [A Document and Data Control (including software and firmware)
    system to control changes affecting and MSC's.]{.underline}

12. (New) [A Production Control system to control changes affecting any
    MSC's.]{.underline}

13. (New) [An Identification and Traceability system (including
    serialization and lot/batch control as applicable) applied, as a
    minimum, to MSC's.]{.underline}

14. (Item 1) Documentation that personnel have been properly trained.

b\. If the manufacturer contracts with an outside laboratory to conduct
the Influence Factor testing, that laboratory will be subject to all
[applicable]{.underline} Conformity Assessment Program requirements.

c\. A subsequent audit report provided by the Registrar, at least every
five years, verifying an on-site visit to the manufacturing facility to
review the statistical quality assurance and production records for all
affected certified devices, and random testing or review of a production
device in the manufacturing facility. ([Note question: Should we still
have some information submitted in the off years between the five
years?)]{.underline}

[]{#AppendixC .anchor}Appendix C

Report on the Activities of the

**International Organization of Legal Metrology (OIML)**

**and**

**Regional Legal Metrology Organizations**

International Legal Metrology Group

Weights and Measures Division, NIST

The International Legal Metrology Group (ILMG) in the Weights and
Measures Division (WMD) of the National Institute of Standards and
Technology (NIST) is responsible for coordinating U.S. participation in
OIML and other international legal metrology organizations. Learn more
about OIML at the ILMG website at
[*http://ts.nist.gov/oiml*](http://ts.nist.gov/oiml) or at the OIML
website at [http://www.oiml.org](http://www.oiml.org/) on the Internet.
Dr. Charles Ehrlich, Group Leader of the ILMG, can be contacted at
<charles.ehrlich@nist.gov> or at 301-975-4834 or by fax at 301-
975-5414.

**Table of Contents**

I.  Report on the Activities of the OIML Technical Committees

II. Mutual Acceptance Arrangement (MAA) on OIML Type Evaluations

III. Report on the 38th Meeting of the International Committee of Legal
     Metrology (CIML)

##### Report on the Activities of the OIML Technical Committees

This section provides a report on the status of work in OIML Technical
Committees (TCs) and Technical Subcommittees (SCs) of specific interest
to members of the NCWM. Also included are reports on recent activities
of those groups and schedules of future activities of Secretariats, the
U.S. National Working Groups (NWGs), and the International Working
Groups (IWGs) of committees and subcommittees.

*TC 3 Metrological Control (United States of America)*

A joint working group of the OIML, the International Bureau of Weights
and Measures (BIPM), and the International Laboratory Accreditation
Cooperation (ILAC) developed the revision of OIML D1 "Elements for a Law
on Metrology". The document is now in its third committee draft, and is
being reviewed by members of TC3 and the Laws and Regulations Committee.
This revision of D1 presents the various elements that should be
considered when preparing laws related to metrology. This document gives
advice on general laws covering all the aspects of metrology, as well as
specific laws related to some distinct aspect of metrology, such as
legal units and traceability. It can also be used to evaluate provisions
related to metrology in more general laws such as those on consumer
protection and conformity assessment. When completed, the document will
be a tool that individuals can use in preparing such laws. They can
select appropriate elements and adapt them into their legislation.
Please contact Kathy Dresser at 301-975-3289 or at
kathryn.dresser@nist.gov if you would like to obtain a copy of the 3^rd^
draft revision of D1 or to participate in this project, which is planned
for final approval in 2004.

*TC3/SC1 "Pattern Approval and Evaluation" (United States)*

The International Documents dealing with metrological control of
measuring instruments using the processes of type approval and
verification have not been revised in over 15 years. The existing OIML
documents are D19 "Pattern evaluation and pattern approval" and D20
"Initial and subsequent verification of measuring instruments and
processes." A first US proposal has been circulated for a combined
revision of OIML D19 and D20 into a single document "Principles of
metrological control of measuring instruments: type approval and
verification."

The existing documents are out of date since they do not include
developments of the last fifteen years, such as the OIML certificate
system, D27 "Initial verification of measuring instruments utilizing the
manufacturer\'s quality management system," and the "Framework for a
mutual acceptance arrangement (MAA) on OIML type evaluations."
Consideration needs to be given to the appropriate conformity assessment
options developed by the ISO Council Committee on Conformity Assessment
(ISO CASCO). This includes quality systems, product certification, and
accreditation. Consideration needs to be given as well to information
technology and statistical methods to increase or decrease verification
intervals based upon proven instrument performance. For more information
on this activity, contact Dr. Ambler Thompson at 301-975-2333 or at
<ambler@nist.gov>.

*TC 5/SC 1 Electronic Instruments (Netherlands)*

A meeting was held in the Netherlands in October 2002 to discuss
comments received on the 2^nd^ committee draft (2CD) of a revision of
D11 \"General Requirements for Electronic Measuring Instruments*.*\"
There were a number of new proposals for tests to be added to D11. Based
on meeting discussions and other comments received on the 2CD, a 3CD was
circulated by the Secretariat in May 2003. The US voted yes and provided
comments on the 3CD in September 2003. This is an especially important
document in the OIML system because its testing requirements will become
general guidance for all OIML recommendations for electronic measuring
instruments. For more information on this activity, contact Dr. Ambler
Thompson at 301-975-2333 or at <ambler@nist.gov>.

*TC 8/SC 3 "Measuring Instruments for Liquids other than Water."
(Germany) and*

*TC 8/SC 4 "Dynamic Mass Measurements (Liquids other than Water)"
(United States)*

OIML R117 "Measuring Instruments for Liquids other than Water" is
undergoing an extensive revision \-- incorporating new instrument
technologies and merging the document with OIML recommendations R86
"Drum Meters" and R105 "Mass Flowmeters." This is a high priority
project for OIML, and ILMG is working with the U.S. National Working
Group on flowmeters, Germany, and the Netherlands (convener of the work
group tasked with revising R117) on this effort. Meetings of the U.S.
National Working Group on flowmeters were held during the NCWM Interim
Meeting in January 2003 and the NCWM Annual Meeting in July 2003.
Measurement Canada has been a strong contributor to this effort. An
aggressive timetable for TC8/SC3 and SC4 to complete this major project
is ongoing.

An extremely productive joint meeting of OIML TC8/SC3 and SC4 was held
October 6-9, 2003 in Paris, France. The meeting was very well attended
by 45 participants, including official representatives from 17
countries. Several representatives of major U.S. manufacturers of these
systems actively participated in the meeting. These technical experts
provided a depth of experience and technical expertise that proved
highly valuable during the meeting. Working from the first committee
draft of R117 (1CD, Aug 2003), participants at the 4-day Paris meeting
successfully completed a hefty and detailed agenda designed to resolve
several key issues on the document's revision. Some of these key issues
included: conversion devices, electronic sealing, significant faults,
endurance testing, and required documentation. Based largely on the
consensus decisions reached by meeting participants, the second
committee draft (2CD) of R117 is expected to be ready for review in
December 2003. If you have questions or would like to become more
involved with this effort, please contact Mr. Ralph Richter at
<ralph.richter@nist.gov> or 301-975-4025.

*TC8/SC5 "Water Meters" (United Kingdom)*

The amended R49-1 "Water Meters Intended for the Metering of Cold
Potable Water: Metrological Requirements" was republished and placed on
the OIML web site in April 2002. Amended versions of both R49-2 "Test
Methods" and R49‑3 "Test Report Format" were approved for publication at
the November 2003 CIML meeting in Kyoto, Japan.

*TC8/SC7 "Gas Metering" (Belgium and France)*

An IWG meeting was held in Brussels in March 2001 to discuss a 2^nd^ CD
draft of OIML Recommendation "Measuring Systems for Gaseous Fuel" to
include natural and compressed natural gas. The meeting focused on
discussion of comments on the 2^nd^ CD draft Recommendation. A second
meeting of the IWG focused on a 2^nd^ CD Recommendation "Measuring
Systems for Compressed Natural Gas (CNG) for Vehicles" and annexes
covering performance tests for electronic devices and basic test
procedures. The Secretariat circulated a 3^rd^ CD "Measuring Systems for
Compressed Natural Gas (CNG) for Vehicles" for comment and vote. In
April 2003, the United States cast a negative ballot because the testing
requirements were unrealistic. Please contact Wayne Stiefel at
301-975-4011 or at [stiefel@nist.gov](mailto:kbutcher@nist.gov) if you
would like to obtain a copy of the 3rd CD or participate in this
project.

*TC 8/SC 8 "Gas Meters" (Netherlands)*

The Secretariat sent the members of the committee a letter with the
results of a questionnaire asking for comments to guide the initiation
of a work program to revise R6 "General provisions for gas volume
meters," R31 "Diaphragm Gas Meters", and R32 "Rotary Piston Gas Meters
and Turbine Gas Meters." A small majority of members voted to produce
one new recommendation for gas meters that will replace R6, R31, and
R32. The Secretariat reported that they would develop an initial draft.
The new document, according to the Secretariat, may consist of a general
chapter mainly consisting of R6 and those aspects in common with R31 and
R32 and separate chapters on household and industrial gas meters. The
U.S. NWG provided comments and will participate in the development of
the new Recommendation. Please contact Wayne Stiefel at 301-975-4011 or
at [stiefel@nist.gov](mailto:kbutcher@nist.gov) if you would like to
participate in this project.

*TC 9/SC 1 "Nonautomatic Weighing Instruments" (Germany and France)*

In May of 2002, Germany and France, the co-secretariats of OIML TC 9/SC
1 "Non-automatic Weighing Instruments" (NAWI), announced that they had
initiated the first review of OIML Recommendation 76 "Non-automatic
Weighing Instruments" since 1994. This review cycle is of major
importance to U.S. interests because R76 serves as the foundation for a
majority of the laws and regulations that governs weighing instruments
around the world. This review is significant for U.S. weighing
instrument manufacturers because the international harmonization of
requirements will eliminate technical barriers to trade and reduce the
delays and the cost of getting new weighing instruments into the global
marketplace. It is also important for legal metrology officials since it
is taking place when the NCWM is considering entering into Mutual
Acceptance Arrangements for type evaluations with other countries (e.g.,
Germany). This effort supports one of the Conference's long-range
strategies that is to "work toward the harmonization of U.S. (e.g., NIST
Handbook 44 "Specifications, Tolerances, and Other Technical
Requirements for Weighing and Measuring Devices") and international
standards." The review process for R76 began with the Co-Secretariats
requesting comments from Member States using a questionnaire. The US is
expecting the first working draft of the revised R76 in November or
December 2003. If you would like to participate in this effort, please
contact Steve Cook at 301-975-4003 or <steven.cook@nist.gov>.

*TC 9/SC 2 "Automatic Weighing Instruments" (United Kingdom)*

In July of 2003, the US voted "no" on a third committee draft of
Recommendation \"Automatic Instruments for Weighing Road Vehicles in
Motion - Part B - Axle Loads\" that was prepared by the OIML Secretariat
in the United Kingdom. Several technical and clarification items were
forwarded to the secretariat as justification for this negative vote. If
you would like to receive a copy of the latest draft of this document or
participate in this work please contact Richard Harshman at 301-975-8107
or <harshman@nist.gov>.

*TC17/SC1 "Humidity" (China)*

In February 2001, the 1^st^ Committee Draft Revision of OIML R59
\"Moisture Meters for Cereal Grains and Oilseeds\" was received from the
TC17/SC1 Secretariat, the Peoples Republic of China. The current edition
of R59 was developed in the 1980s and includes technical and
metrological requirements for both automatic and manual meters. A U.S.
National Working Group reviewed the draft revision of R59 and sent
comments to the Secretariat in the spring of 2001. Because of
substantial problems with this draft, the Secretariat asked the United
States to prepare a new OIML draft based on the National Conference on
Weights and Measures National Type Evaluation Program (NTEP)
requirements. A working draft of the Recommendation was prepared based
upon requirements for moisture meters in Handbook 44 and Publication 14.
After preparation by the United States, this working draft was
distributed by China to the IWG in February 2003 for comment. Based on
comments received on the working draft, a first committee draft was
distributed to the IWG in May 2003. Both drafts were also distributed to
the U.S. National Working Group, which for the most part is a subset of
the NTEP Grain Sector. In October 2003, China hosted a meeting of the
TC17/SC1 subcommittee in Beijing to review and discuss this revised
document. Please contact Diane Lee at 301-975-4405 or at
<diane.lee@nist.gov> if you would like to participate in this working
group.

##### II. Mutual Acceptance Arrangement (MAA) on OIML Type Evaluations 

The MAA document and its associated document "Checklists for issuing
authorities and testing laboratories carrying out OIML type evaluations"
were both adopted at the 38th CIML meeting in November 2003 in Kyoto,
Japan, after presentations given by the BIML Director and Dr. Charles
Ehrlich, the Secretariat of TC3. The CIML agreed to set up a working
group in order to address the financial aspects of the implementation of
the MAA and to come up with financial regulations for this MAA before
the 2004 CIML Meeting. The CIML also instructed the BIML and the TC3
Secretariat to prepare for the implementation of the MAA as soon as
possible.

**III. Report on the 38th Meeting of the International Committee of
Legal Metrology (CIML)**

Representatives from 49 of the 60 member nations participated in the
38^th^ Annual Meeting of CIML from November 5-8, 2003, in Kyoto, Japan.
The CIML President welcomed two new member countries, New Zealand and
Vietnam. Meetings of the OIML Presidential and Development Councils were
also held. Dr. C. Ehrlich is the CIML Member for the United States.

The CIML approved the following draft Recommendations and Documents in
Kyoto:

-   Revision of R 48\
    *Tungsten ribbon lamps for calibration of radiation thermometers*;

-   Amended version of R 49-2\
    *Water meters intended for metering cold potable water. Part 2: Test
    methods;*

-   Draft Recommendation R 49-3\
    *Water meters intended for metering cold potable water. Part 3: Test
    report format;*

-   Revision of R 52\
    *Hexagonal weights, ordinary accuracy class from 100 g to 50 kg*;

-   Revision of R 61-1\
    *Automatic gravimetric filling instruments, Part 1: Metrological and
    technical requirements - Tests*;

-   Draft Revision of R 61-2\
    *Automatic gravimetric filling instruments. Part 2: Test report
    format;*

-   Revision of R 87\
    *Quantity of products in prepackages*;

-   Draft amendment to OIML R 99/ISO 3930\
    *Instruments for measuring vehicle exhaust emissions;*

-   Draft Recommendation R 134\
    *Automatic instruments for weighing road vehicles in motion - Test
    Report Format; and*

-   New Recommendation (R 135)\
    *Spectrophotometers for medical laboratories*.

*Budget*

The BIML Director gave a presentation on a preliminary proposal for the
2005-2008 OIML budget. The Committee approved the guidelines set out in
this document and instructed the BIML Director to prepare a proposal for
the 2004 Conference, highlighting the distinction between (1) the normal
budget, financed by Member State Contributions, and other usual income
of the Organization; and (2) the optional, additional budget,
corresponding to the implementation of the MAA and changes in the way in
which publications will be distributed, and whose charges and income
shall be specific. The Committee also noted information given by the
BIML Director concerning the revision of the OIML Financial Regulations.
The Committee instructed the Bureau to complete this Draft Revision and
to submit it to Member States in time for approval at the 39^th^ CIML
Meeting and 12^th^ OIML Conference in 2004.

*Work of the TCs/SCs*

Concerning the OIML technical activities, the CIML expressed its
satisfaction with the increased volume of work accomplished during the
last 12 months (compared with the previous one-year period). The CIML
requested OIML TCs and SCs continue to accelerate their work, especially
in the fields listed as high priority and priority projects. The
Committee discussed several proposals included in the document entitled
\"Acceleration of OIML technical work,\" instructing members to start
implementing the proposed actions. The Committee also instructed the
BIML to regularly report back at CIML Meetings on the measures taken and
results achieved.

The Committee approved the project as proposed by TC 18 on *Ophthalmic
instruments - Impression and applanation tonometer.*

The Committee noted a proposal submitted by France to develop
\'interpretation documents\' pertaining to the accreditation of legal
metrology Issuing Authorities and Testing Laboratories. Noting an
agreement between the TC3/SC5 Secretariat (U.S.) and the BIML, the
Committee instructed TC3/SC5 to set up a Working Group (convened jointly
by France and the BIML) to develop the first drafts of these documents.

The Committee also noted information provided by the BIML on the
generally unsatisfactory situation of CIML postal voting in 2003, and
requested its Members (especially those who are late in voting) to
comply more regularly with fulfilling their duties, thus contributing to
the timely approval of drafts submitted.

### *OIML Certificate System*

The CIML decided that the following Recommendations would be applicable
within the OIML Certificate System when published:

-   Revision of R 48, *Tungsten ribbon lamps for calibration of
    radiation thermometers*;

-   New Recommendation - R 135, *Spectrophotometers for medical
    laboratories*.

The CIML noted several proposed actions for implementing the revised P1
"OIML Certificate System for Measuring Instruments:"

-   The responsible TCs/SCs should include new provisions for modules
    and families of measuring instruments (as far as the definition of
    families, identification of modules and/or families together with
    their metrological requirements, test methods, and test report forms
    are concerned) when developing new or revising existing
    Recommendations intended for application within the OIML Certificate
    System, in order that Certificates may be issued accordingly;

-   The TCs/SCs concerned should accelerate the development of
    horizontal type OIML Documents (e.g. on software, uncertainty, etc.)
    to be implemented when drawing up new and revised Recommendations;

-   The BIML should assist TCs/SCs and Issuing Authorities in the
    implementation (realization of new and additional tasks) of the
    revised P1; and

-   CIML Members and the BIML should pursue further general actions in
    promoting the OIML Certificate System at national, international and
    regional levels, and keep international and regional organizations
    in liaison with the OIML informed of the advantages of the OIML
    Certificate System with special regard to its new features.

The Committee instructed the BIML to carry out inquiries among OIML
members and among manufacturers and applicants who already possessed
OIML certificates as to their experience in the voluntary acceptance and
use of OIML certificates for national or regional type approvals, as
well as to their views on the functioning of the OIML Certificate System
with a special view to the new provisions of P1. The outcome of these
inquiries shall be included in the report on the OIML Certificate System
to be presented in 2004.

### *Study on the benefits of legal metrology*

Mr. John Birch gave a presentation on his report *The Benefits of Legal
Metrology for the Economy and Society*. The Committee expressed its
great appreciation of this report and instructed the BIML to distribute
it as an expert report. A summary report compiled by Mr. Birch would
also be published in the OIML Bulletin. The Committee instructed the
CIML President and the BIML to consider any complementary actions or
studies, which would be helpful in raising the awareness of metrology
and legal metrology.

### *Liaisons with international and regional institutions*

The CIML President gave a report on the good cooperation OIML enjoys
with the Metre Convention (BIPM/CIPM) and with ILAC.

The Committee approved a policy paper on OIML liaisons with other
organizations.

The Committee noted a progress report given by the BIML Director on a
paper formalizing OIML relations and cooperation with Regional Legal
Metrology Organizations (RLMOs); this paper is being submitted for
comments to the RLMOs. The Committee instructed the BIML to continue
progress with this paper so as to establish a formal framework for OIML
cooperation with the RLMOs.

####### Upcoming OIML Meetings

The next meeting of the OIML Presidential Council will be held in March
2004 in Paris. The 2004 CIML meeting will be held in conjunction with
the next quadrennial OIML Conference in Berlin, Germany, from October 25
-- 29, 2004. The 2005 CIML meeting will be held in Paris to coincide
with the 50^th^ Anniversary of the establishment of OIML.

[]{#AppendixD .anchor}Appendix D

**Harmonization with OIML: What It Means and How It Will Happen**

Ross Andersen, NTEP Chair

Version 1: November 19, 2003

The NCWM Board recognized the importance of harmonization with OIML in
its strategic plan. Several initiatives are already underway to move the
NCWM in that direction, so this is now much more than a plan. This
article is intended to provide the NCWM membership with a simple roadmap
of what is happening and who will have responsibilities to make it a
reality.

Perhaps the first issue that must be addressed is to clarify what
"harmonization" is. In simple terms, harmonization is making
requirements in U.S. and OIML documents consistent to the extent
practical, in order to reduce or remove technical barriers to trade. The
United States, as a signatory of the OIML Convention, has obligations to
consider OIML recommendations whenever amending its technical
regulations and use the OIML standards except where there is compelling
reason to do otherwise. However, the U.S. system and its approach to
regulation are somewhat different from other countries and this adds to
the difficulty.

The United States does not have a single mechanism to harmonize with
OIML at the federal level as other countries do. Weights and measures in
the United States is primarily a state and local function. The NCWM was
conceived to get the states to buy-in and work together in order to have
a uniform system of regulations. The NCWM, as the primary U.S. standards
setting organization in the legal metrology field, thus bears the
responsibility of following through to meet our treaty obligations.

The U.S. approach to legal metrology is primarily directed to field
verification. In its introduction, Handbook 44 states that the purpose
of the requirements is to "eliminate from use" devices that are
inaccurate, or false, or facilitate the perpetration of fraud. In
contrast, the OIML recommendations are aimed primarily at the type
approval process. OIML creates recommendations to provide a uniform
means of evaluating the design and performance of weighing and measuring
instruments.

The differences in approach produce differences in the technical
documents that further add to the difficulty in harmonization. Other
nations use the OIML Recommendations in their type approval programs.
They use the test procedures and report forms in the annexes. For the
most part, field verification and field test procedures are not part of
the OIML technical standards, but are developed separately in different
countries as national legislation that is supplemented with specific
test procedures based on the Recommendations. (See Figure 1.) The U.S.
documents do essentially the same things, but not with direct
correlation to the OIML documents. When we harmonize, it will not
necessarily mean the adding or amending a paragraph in Handbook 44.

![](media/image1.png){width="4.604861111111111in"
height="2.8354166666666667in"}

With these differences in mind, the Board has set some broad objectives
to move ahead in a three-pronged attack. This involves the NIST
International Legal Metrology Group (ILMG) in the Weights and Measures
Division (WMD), the NCWM standing committees, and the NTEP sectors, each
working in its particular area of responsibility and using appropriate
procedures to ensure due process. The NIST ILMG or other WMD staff will
take the U.S. positions to OIML technical committees or subcommittees in
those areas where we think we have a better standard or the OIML
standard could be improved. The NCWM standing committees will consider
proposals to change the U.S. technical standards to remove barriers to
trade. The NTEP sectors will consider amendments to Publication 14. In
addition, where federal agencies have regulations preempting the states,
these agencies will have similar obligations to harmonize their
requirements with OIML. The NCWM is essentially a public participant in
these federal regulatory activities. I included them in Figure 2 below
only for reference and not as part of the NCWM strategic plan. Hopefully
the NCWM will be an active participant in those areas like metric only
labeling.

![](media/image2.png){width="5.002083333333333in"
height="3.203472222222222in"}

The work of the three groups needs to be coordinated and there will be
considerable need for education as we move forward with the
harmonization process as indicated in Figure 2. The process can
originate at any level in the system, from individuals to the Committees
charged with the responsibility for the codes. It is important to
realize that OIML has a schedule of revision of its documents that is
largely outside of U.S. control, and so the ILMG/WMD staff will
accordingly be bringing matters to the attention of NCWM when they arise
in OIML. All of the involved parties need to work together to take the
necessary steps to bring about change. This includes:

-   Identifying technical barriers to trade (i.e., differences between
    OIML and U.S. requirements);

-   Fostering discussion on where to consider changes (in OIML
    recommendations, U.S. standards, or Pub 14);

-   Setting priorities on which issues to tackle first;

-   Educating affected parties of the needs/benefits of harmonization;
    and

-   Promoting the necessary action at the appropriate level with due
    process.

Changes proposed to OIML standards will go through the NIST ILMG/WMD to
the OIML technical committees and subcommittees. The United States has
been successful in getting OIML to accept some of our ideas. When we
originally proposed the mix and match concept, OIML rejected it.
However, today they recognize what they call modules and have a system
of apportioning the errors to modules that may be superior to ours.

We may want to make changes to NCWM standards in some areas. For
example, in the area of device terminology, we have differences that
could easily be changed. Automatic zero setting mechanisms could easily
be renamed to the OIML term "zero tracking" with little fanfare. At the
other extreme, changing all our Class III L vehicle scale requirements
to meet OIML Class III might be quite hard to sell to our manufacturers
and users. Any changes proposed to our technical standards would go
through the NCWM standing committees to ensure due process is observed.

In the third area, i.e., changes to Pub 14, any proposals for change
will go through the NTEP sectors and the NTEP Committee. These changes
may be mostly transparent to the end user and the field inspector. For
example, our test procedures for load cells are fairly close to the
OIML. Except for some specific tests for humidity and electrical
disturbances, we could adopt the OIML procedures today. We must examine
the nature of the link between NTEP and the technical regulations in
Handbook 44. Each NTEP certificate includes a statement that the device
has demonstrated ability to comply with the Handbook. Obviously we can't
use test methods in NTEP that evaluate to a lower standard. On the other
hand, can we test using a stricter standard? For example, Class III
scales in the Handbook have a fourth tolerance step, not present in
OIML. If the scales and load cells were evaluated per OIML tests with
only three tolerance steps, it may easily satisfy compliance with the
extra step. In many cases the OIML standards are stricter than U.S.
standards. Using OIML test procedures and standards in NTEP would serve
to harmonize, would produce better devices, and would still be almost
transparent to the user and the field official.

OIML spreads out the technical work and has been successful in using
electronic means to reduce need for meetings. They have a system of
about 50 technical committees and subcommittees, 20 of which deal with
weights and measures law, trade devices and prepackages, while we have
only our L&R and S&T Committees and our sectors. Consider also that
their Technical Committees don't have to deal with application or field
testing issues that often dominate our agendas (i.e., 17 of 24 voting
items on 2003 S&T agenda were field related). Whether it is a national
working group, a regional association, or an NTEP sector, we in the
United States need to ensure that we get the experts involved as we
review and update our technical standards.

In all of these harmonization activities, there is another important
support layer. Regional and state W&M associations, industry
associations and individual companies, state and local W&M jurisdictions
and officials, technical advisors from NIST and Measurement Canada, and
other interested parties all contribute to the work of the NCWM. Most of
these are already actively involved in NCWM standards setting for
application and field enforcement issues. I fear that these groups may
not be fully equipped to deal with device specifications and performance
standards. In some respects the NTEP sectors have been asked to fill
that role. I believe that the U.S. National Working Groups (U.S.NWGs)
need to become the center of our technical work on device specifications
and performance standards. I believe the U.S. NWGs need to be thought of
as part of the NCWM support structure on a par with our regional and
industry associations. To this end, it is vital that knowledgeable
regulatory officials from the federal regulatory agencies and the state
and local jurisdictions get involved in these activities. To get
involved, contact the NIST ILMG. You can participate at any level from
observer to full member.

I have heard it expressed that extensive adoption of OIML standards may
make the work of the S&T Committee unnecessary. I have come to believe
that adoption of OIML standards will only make that work more important.
In between updates of the OIML standards there are always new technical
issues to face that impact design and performance. In addition, OIML
technical regulations must be supplemented by national legislation in
the areas of application and verification. Change is inevitable and we
will continue to adjust our standards and our regulatory system to
adapt.

I can report a major success that began with a NIST-contracted
comparison of scale requirements in Handbook 44 and OIML R76 by John
Elengo. That comparison served as the focus of a meeting of the weighing
instruments U.S.NWG in August. The group provided the NIST ILMG with a
number of items to take to OIML committees working on R76. It also
identified and prioritized some efforts to change U.S. requirements in
both Handbook 44 and Pub 14. As a result, this year and for years to
come, I expect to see harmonization issues appear on our S&T Committee
and Weighing Sector agendas. I also expect to see U.S. ideas showing up
in OIML documents. NIST has already contracted for a second such
comparison on liquid measuring devices. As we work on these items
together, it is my hope that we continue to move forward in removing
barriers to trade in a process that will help make our regulatory system
stronger and make the United States stronger in the world market. I am
confident that as we learn more about the OIML standards we will see
more benefit in using them.