STANDARD REFERENCE MATERIALS PROGRAM
Sections
5.19.06 SRM Process, Including Funding and Statements of Work
5.19.07 Cost Recovery and Pricing
5.19.08 Non-Delivered, Obsoleted, Discontinued, Restricted, and Limited-Purchase Projects
Appendix A – Explanation of SRM Statement of Work
Appendix B – SRM Work Involving Other Organizations
5.19.01
PURPOSE
This subchapter states NIST policies and procedures for developing,
certifying, and distributing NIST Standard Reference Materials (SRMs) and
Reference Materials (RMs) (see Section 5.19.09 for definitions).
(Note: In this subchapter, the term SRM refers to both SRM and RM, unless
otherwise indicated.) It is intended to aid producers of NIST SRMs
in the selection and creation of new reference materials and to provide
background into the SRM process and the roles of the various NIST organizational
units that contribute to the goals of the NIST SRM Program.
5.19.02
SCOPE
The procedures and policies outlined in this subchapter apply to both
NIST-Gaithersburg and NIST-Boulder. For purposes of this subchapter,
the term “SRM Program” refers to the entire NIST-level Standard Reference
Materials Program, not just the centralized pre- and post-production support
provided by the Measurement Services Division (MSD) in Technology Services
(TS) (see Section 5.19.04b).
This subchapter supercedes the NIST Policy on SRMs (formerly referred
to as the NIST Laboratory Council Policy on SRMs) dated October 25, 1999,
and represents the decisions of the NIST Measurement Services Advisory
Group (MSAG) (see Section 5.19.04f).
5.19.03
BACKGROUND
Since 1906, SRMs have been used by NIST as a vehicle for transferring
measurement science and technology throughout the scientific community,
industry, and commerce. NIST ensures accurate and compatible measurements
through the development, certification, and distribution of SRMs available
for use in areas such as industrial materials production and analysis,
environmental analysis, health measurements, and basic measurements in
science and metrology.
Industry, government, and academia use NIST reference materials to ensure the highest quality measurements. SRMs are key tools for verifying important measurement results, developing new measurement methods, and providing users with tools to assist in establishing traceability of measurement results to NIST.
NIST SRMs are provided when:
a. A measurement problem has been identified for which a Certified
Reference Material from NIST has been determined to be the most effective
means for providing the required measurement accuracy, traceability, or
both;
b. Industry-wide reference materials or standards for commerce not otherwise available are needed from a neutral supplier; and/or
c. Continuing availability of a highly characterized material from a
common source is important to science or industry.
5.19.04
RESPONSIBILITIES
a. Laboratory – (1) Plans, sets priorities, funds, and implements
the development, production, delivery, and quality of SRMs; (2) establishes
technical criteria for the development and certification of SRMs; (3) determines
specifications for and acquires material; (4) provides MSD with specifications
for material preparation, if appropriate, and storage of units; (5) ensures
that all NIST Working Capital Fund (WCF) resources assigned to it are used
appropriately and properly accounted for; (6) determines the number of
units to be produced and the appropriate time period for cost recovery
with a maximum of five years to calculate the unit sales prices, as well
as provides the basis for the annual unit sales estimate; (7) develops
and carries out a material stability monitoring plan and perpetuation plan
(see Appendix A) for each new SRM; (8) performs continuous assessment of
customer needs and requirements for SRMs; (9) prepares and packages material,
or requests MSD to do so; (10) provides customer technical support as needed;
(11) establishes and maintains a quality system that assures quality in
the results of its measurement services; and (12) provides representation
on relevant national and international committees for the technical aspects
of SRMs.
b. Measurement Services Division (MSD) – (1) Provides guidance to the NIST Laboratories, upon request, for the development, production, and certification of SRMs; (2) performs activities related to preparing, packaging, labeling, pricing, marketing, warehousing, selling, and distributing SRMs; (3) reviews certificates for NIST-wide uniformity and prepares and maintains other documentation (i.e. material safety data sheets) related to SRMs; (4) prepares and updates the Special Publication (SP) 260 SRM catalog and price list; (5) prepares and issues other documents such as journal articles, brochures, and newsletters that provide current information about SRMs; (6) exhibits SRMs and related publications and documentation at technical meetings, conferences, and trade shows; (7) provides the necessary information, reports, and administrative support to NIST customers and Laboratories; and (8) provides national and international representation for business aspects of SRMs.
c. Statistical Engineering Division (SED) of ITL – (1) Assists in the design of sampling and measurement strategies for certification of SRMs; (2) provides technical guidance on the implementation of NIST uncertainty policy; (3) develops standardized statistical design and analysis templates that can be used by Laboratory personnel to carry out statistical analyses for classes of SRMs that follow fixed approaches; (4) provides training on the proper use, interpretation, and limitations of these templates; (5) provides data analysis and uncertainty assessment for SRMs for which appropriate standardized analysis templates are not available; and (6) certifies the computation for unit values and stated uncertainties, as appropriate.
d. Budget Division – (1) Reviews and approves the annual SRM Operations budget as proposed by TS/MSD; (2) reviews and sets annual SRM surcharge levels; (3) determines the annual Service Development (SD) and Working Capital Fund (WCF) Production funding levels, including carryover, and allocates resource directly to the Laboratories; (4) reviews and approves Stock Transfer Notices (STNs) that transfer units to stock and establish unit sales prices; (5) provides the annual inflationary factors for materials and labor to MSD for calculation of the replacement surcharge; and (6) monitors expense and income, work-in-process, and sales activities for the SRM Program.
e. Finance Division – (1) Handles all NIST collections for SRMs sold; (2) handles the deferral of Service Development income in excess of expenses at year-end; and (3) serves as liaison for all financial audit activities regarding the SRM Program.
f. Measurement Services Advisory Group (MSAG) – (1) Establishes
policies related to measurement services and resolves matters that relate
to more than one NIST Laboratory and (2) has oversight of the entire NIST
SRM Program to ensure the Program’s overall long-term health even though
each Laboratory has responsibility and accountability for its individual
SRM technical and financial activities.
5.19.05
SRM RESOURCES
The following describes the types of funding and resources available
to support NIST SRM activities and the appropriate use of each. Refer
to Subchapter 8.02, Fund Structure, for more information regarding NIST’s
funding structure.
a. STRS appropriated funds support the research phase of an SRM, where the concept is explored and provides the main mechanism for increasing production resources through authorized transfers to the Working Capital Fund.
(1) A Laboratory’s SRM research activities are funded with its own STRS
allocation according to each Laboratory’s strategic priorities.
(2) NIST’s STRS budget initiative requestsfrequently include
transfers to the Working Capital Fund for the production of SRMs.
However, the amount of NIST STRS that can be transferred to the WCF is
limited by the authority specified in appropriations legislation.
(3) If the Congress grants transfer authority not specifically
tied to or needed by a budget initiative, the Budget Division will solicit
interest from each Laboratory in transferring their own STRS to the WCF
for SRM production. The Budget Division will then distribute the
total annual transfer amount equally among the interested Laboratories.
(4) Section 5.19.05c(8) also notes that another method of increasing
a Laboratory’s SRM production allocation is through the transfer of invested
equipment funding.
b. Service Development (SD) funds support the development of a prototype of future SRMs and are used to resolve any material or technical issues prior to investing WCF Production funds.
(1) SD provides a means of funding projects to demonstrate the feasibility
of a new SRM base material or certification protocol and to establish the
final procedures for manufacturing the SRM before production activities
are funded on the NIST Working Capital Fund.
(2) The amount of SD funds available in any given year is determined
for each Laboratory by the Budget Division based on each Laboratory’s anticipated
SD collections through the sale of its SRMs. (See also Section 5.19.07.)
c. Working Capital Fund (WCF) resources finance the production of a saleable, cost recoverable product.
(1) Working Capital Fund resources are only used when all material
and technical issues have been resolved in the research (STRS) and development
(SD) phases.
(2) The amount of WCF production funds available in any given year
is determined for each Laboratory by the Budget Division based on previous
and projected rates of WCF replenishment through the sale of the Laboratory’s
SRMs. This sales estimate is adjusted for each Laboratory’s prior
year carryover to determine the Laboratory’s total annual WCF production
allocation.
(3) Each Laboratory has responsibility and control of the WCF assigned
to it within the provisions specified in this subchapter.
(4) It is NIST policy to recover the full production costs of an SRM
within five years. If circumstances exist to justify recovering production
costs in more than a five-year supply of inventory, the Laboratory must
request and receive approval from the MSAG (see Section 5.19.09n) in advance
of beginning production work.
(5) Laboratories are responsible for determining the appropriate
number of units to produce considering the perceived demand for each SRM
based on historical sales rates of the SRM or of similar SRMs, the technical
difficulty of future renewals, the marginal cost of producing additional
units, the cost of storage space, material stability, and other items.
Laboratories may produce more than a five-year inventory supply of a given
SRM. However, as stated in item (4) above, the sales price will be
set to collect all production costs and repay the Working Capital Fund
(WCF) in no more than five years. Units put in inventory after all
production costs have been recovered will be priced to collect Other Factors
income (see Section 5.19.07b).
(6) SRMs must be completed and transferred to finished goods inventory
within three years of the initial labor charges on WCF production funds.
Each quarter, the Budget Division will run a report and communicate to
each Laboratory the SRM projects for which labor charges were initiated
in that quarter. For tracking purposes, the date of the initial labor
charges for each SRM project will be noted by the Budget Division with
a quarter and fiscal year (i.e. 1Q FY04). In a very small number
of instances, material acceptance problems or other exceptional circumstances
may occur. (Note: It is assumed that the number of these situations
is very small because SD is the time to address material problems.)
In these cases, the Laboratory notifies the Budget Division and MSAG if
the problems are not resolved within one year of the initial production
labor charges as well as if a time extension is needed.
(7) If the SRM is not in inventory within three years of the initial
production labor charges, unless an extension has been granted by the MSAG
as cited in item (6) above, the Laboratory is responsible for repaying
the WCF the total amount that was invested in the SRM. See Section
5.19.08a regarding penalties for non-delivery.
(8) If a Laboratory’s annual WCF production allocation is insufficient
to address its SRM production activities, the Laboratory should work with
the Budget Division to transfer some of its (i) invested equipment (IE)
or (ii) STRS funds to its SRM production allocation, within NIST’s annual
statutory transfer authority limit.
(9) If NIST acquires additional Working Capital funds through the annual
appropriation process or other means and the assignment of those funds
to a specific Laboratory is unclear, the Budget Division will solicit interest
from each Laboratory in receiving a portion of the additional funds.
The Budget Division will then divide the total amount of additional funds
equally among the interested Laboratories.
d. Federal government agency funds or services may be provided to NIST for the research, development, or production, or all three phases, of an SRM, as specified in the agreement between NIST and the other federal government agency.
(1) NIST does not have legislative authority to transfer
other federal government agency funds to the NIST WCF for SRM production.
Therefore, unless the federal sponsor is authorized to transfer funds to
NIST, the federal government sponsor’s share of the sales income must be
returned to the sponsor. See Appendix B for more information regarding
SRM work involving other federal government agencies.
(2) Procedures for work sponsored by outside organizations, both federal
and non-federal, are contained in Subchapter 8.05. The Counsel for
NIST must be consulted if circumstances arise that are not covered in this
subchapter or Subchapter 8.05.
e. Non-federal government (NFG) sponsor funds or services for SRM work may be provided only after the appropriate approvals have been received by the NIST Laboratory.
(1) Agreements with NFG sponsors involving SRMs must be reviewed and
approved by the Budget Division and the Counsel for NIST prior to work
performed.
(2) See Appendix B for more information regarding SRM work involving
NFG sponsors.
f. Donated material or services may be accepted to develop or produce an SRM, but these donations must adhere to the guidelines in Subchapter 8.10, Gifts and Bequests.
(1) The Statement of Federal Financial Accounting Standards (SFFAS)
Number 3, dated October 27, 1993, requires that “donated inventory shall
be valued at its fair value at the time of donation.”
(2) Laboratory technical staff determines the fair value of the donation
and provides this information to MSD for pricing purposes.
(3) Section 5.19.07b explains the method of recovering the value of
donations in the sales price of the units using Other Factors.
g. Stability testing funds support the cost of testing units already in inventory for which deterioration is expected to occur.
h. Operations funding supports the Measurement Services Division’s
administrative support and centralized business and information services
expenses related to SRMs.
5.19.06
SRM PROCESS, INCLUDING FUNDING AND STATEMENTS OF WORK
The following describes the major steps in the development, production,
and delivery of an SRM.
http://www-i.nist.gov/admin/mo/adman/SRMAdManFigure.gif
Pre-Production
a. Identify customer needs
Based on information gathered by NIST staff from market research and analysis, standards bodies, other government agencies, industrial groups, professional societies and other contacts with outside groups, Laboratory staff is responsible for determining the appropriate traceability link.
b. Determine if NIST can and should meet need
Once a need has been identified, the Laboratory staff assesses if the need can and should be met by NIST, considering among other items (i) whether the need can be met by a source other than NIST and if so, why NIST should meet the need, (ii) the impact on industry of meeting or not meeting the need, (iii) the level of effort required to meet the need, and (iv) the estimated present and future demand for the SRM.
c. Develop method
(1) Laboratory staff develops proposed SRM specifications and decides
on the appropriate certification mode (see SP 260-136).
(2) The measurement process is designed by the Laboratory staff.
(3) Laboratory staff consults with SED regarding the design of new
or modified measurement processes.
d. Develop, prioritize, and fund Service Development (SD) projects at the Laboratory level
(1) It is expected that SD projects will be carried out for no more
than one year prior to requesting WCF. In some instances, the
production procedures may be sufficiently well established such that the
SD phase of development can be eliminated.
(2) Laboratory technical staff develops a Statement of Work for each
SD project to be funded in the following fiscal year. See Appendix
A for information required in the SRM Statement of Work. This Statement
of Work should, as appropriate, reflect the need for material processing
work to be provided by MSD and statistical services to be provided by SED.
(3) Laboratory technical staff consults with MSD and SED staff, as
appropriate, to identify cost estimates regarding material processing and
statistical work, respectively. If SED will provide SRM statistical
services to a Laboratory, it is the Laboratory’s responsibility to provide
to SED the necessary documentation regarding the specific SRMs.
(4) The Budget Division provides, on a Laboratory by Laboratory basis,
an annual estimate of the SD funds available for the following fiscal
year, as well as the portion of this estimate available October 1st (referred
to as the initial SD allocation).
(5) Laboratories establish projects and Budget Operating Plans (BOPs)
for each SRM SD project totaling to the initial allocation amount
and submit a prioritized listing and related Statements of Work that reflect
only those projects being established with the initial allocation
amount to the Budget Division with copies to MSD for documentation purposes.
The Budget Division will not approve the SRM BOPs until it has received
the prioritized lists and Statements of Work as supporting documentation
for the projects.
(6) After the start of the fiscal year and when actual SD carryover
is known, the Budget Division provides by Laboratory the additional SD
funds available (referred to as the supplemental SD allocation).
(7) Laboratories establish projects and BOPs for each additional SD
project totaling to the supplemental allocation amount and submit
an updated prioritized listing, including those projects being established
with the supplemental SD funding, and related Statements of Work for those
additional projects, to the Budget Division with copies to MSD for documentation
purposes.
(8) Coincident with the allocation of SD funding, an information folder,
called an “R” (research) folder, is created in MSD which will contain all
technical and financial documentation and information pertaining to the
SRM.
e. Develop Prototype SRM
Upon completion of the SD funding phase for an SRM, a short status report documenting that the project is or is not ready for the WCF production phase is prepared by the Laboratory staff and submitted to its Laboratory management with a copy sent to MSD for inclusion in the “R” folder.
f. Develop, prioritize, and fund WCF production projects at the Laboratory level
(1) WCF production funds can only be used for projects ready for the
production phase. Projects ready for production have (i) demonstrated
analytical or measurement techniques that provide the accuracy needed,
(ii) established uncertainty of certified values that will meet customers’
needs, (iii) material appropriate for the situation, and (iv) material
acceptance that is expected to be routine.
(2) Laboratory technical staff develops a Statement of Work for each
SRM WCF production project to be funded in the following fiscal year.
See Appendix A for information required in the SRM Statement of Work.
(3) Laboratory technical staff should consult with MSD, as appropriate,
to identify estimates for MSD’s material processing and special packaging
costs. If MSD will provide material processing or special packaging
services, the Laboratory includes these cost estimates in the SRM’s Statement
of Work.
(4) SED’s annual estimated expenses for statistical services are determined
at the Laboratory, not SRM, level. A portion of each Laboratory’s
annual WCF production allocation, including mid-year allocations or transfers,
will go to SED to cover statistical services provided for that Laboratory’s
SRMs. SED’s annual SRM production allocation equals a predetermined
percentage, previously approved by the MSAG and the Budget Division, of
each Laboratory’s total annual estimated SRM production labor expenses.
(5) The Budget Division provides, on a Laboratory by Laboratory basis,
an annual estimate of the WCF production funds available for the
following fiscal year, as well as the portion of this estimate available
October 1st (referred to as the initial WCF production allocation).
(6) Laboratories establish projects and Budget Operating Plans
(BOPs) for each SRM WCF production project totaling to the initial allocation
amount, less the portion of funds to go to MSD and SED, and submit a prioritized
listing and related Statements of Work to the Budget Division with copies
to MSD and SED for documentation purposes. The priority listing
and Statements of Work should only reflect those projects that are being
established with the initial allocation amount. The Budget
Division will not approve the SRM production BOPs until it has received
the prioritized lists and Statements of Work as supporting documentation
for these projects.
(7) After the start of the fiscal year and when actual WCF carryover
is known, the Budget Division provides by Laboratory the additional WCF
production funds available (referred to as the supplemental WCF production
allocation).
(8) Laboratories establish projects and BOPs for each additional WCF
production project totaling to the supplemental allocation amount,
less the portion of funds to go to MSD and SED, and submit an updated prioritized
listing, including those projects being established with the supplemental
SRM WCF Production funding, and related Statements of Work for those additional
projects, to the Budget Division with a copy to MSD and SED for documentation
purposes.
(9) Subchapter 8.07 contains procedures for funding the production
of SRMs on demand.
Production
g. Develop final technical plan
(1) The experimental design includes (i) the required properties of
the base material and SRM unit, (ii) the statistical plan for sub-sampling
and measurement (including appropriate homogeneity assessment), (iii) the
required scope of measurement data and limits of uncertainty, techniques,
and methods to be used in the measurement process, (iv) the requirements
for homogeneity and stability for the intended use, and (v) any packaging
and shipping requirements or concerns.
(2) The certification plan includes either (i) certification at NIST
using a primary method with confirmation by other methods, (ii) certification
at NIST using two or more critically evaluated independent methods, (iii)
certification/value assignment using one method at NIST, or (iv) different
methods by outside collaborating laboratories. The certification
plan identifies if SED will conduct the analysis of the data or if the
Laboratory will do the analysis using certified SED procedures or software.
It also includes the need and level of effort for stability testing.
(3) Statistical issues are addressed by each Laboratory with input
from SED as required and requested. If a concern arises related to
a given SRM that cannot be resolved between the divisions involved through
normal communication channels, the Laboratory will present the issue to
the MSAG for resolution.
h. Material acquisition, preparation, and processing
(1) Material acquisition is a responsibility of the Laboratories; however,
MSD staff may be consulted regarding specific requirements. Note
that funds may be requested for material acquisition in a time period prior
to beginning actual work on the SRM.
(2) Material preparation and processing may be performed by either
the Laboratory or MSD staff. However, in either case, Laboratory
staff consults with MSD staff during the development of the Statement of
Work to accurately identify funds, specifications, and responsibility in
advance of work being performed.
i. Material analysis/measurement
(1) Laboratory technical staff applies the measurement method to obtain
certification data.
(2) SED provides, as appropriate, statistical experimental designs
and data analysis. SED may also provide a certified template for
calculations of the certified values and uncertainties.
(3) Laboratory staff determines certified values and uncertainties
and develops the draft certificate in consultation with SED staff, as appropriate.
Prior to sending the draft certificate to MSD, Laboratory staff has addressed
all statistical issues with input from SED as required and requested.
(4) A Laboratory’s SRM production responsibilities are considered complete
once the Laboratory’s technical staff submits the draft certificate, report
of analysis 1/, units of the certified material, and other required
information to MSD in compliance with the quality system 2/ .
1/ The term report of analysis is used here generically and refers
to all official similar reports including report of certification.
2/ Quality system currently under development.
Post-Production
j. Documentation review
(1) The Documentation and Quality Services Group of MSD begins an SRM’s
documentation review and processing upon the receipt of electronic copies
of both the draft certificate and report of analysis (ROA), or similar
official report such as a report of certification, from the Laboratory.
All statistical issues related to the SRM have been resolved by the Laboratory
staff with input from SED as required and requested prior to sending the
draft certificate to MSD.
(2) MSD staff reviews the draft certificate for NIST-wide uniformity
and MSD formatting consistency.
(3) If a Material Safety Data Sheet (MSDS) is required, MSD creates
the document and registers the SRM under HAZMAT requirements.
(4) MSD staff sends the proofed draft certificate to the Laboratory
technical staff for technical review. If a concern arises during
the documentation review process on a given SRM that cannot be resolved
through normal communication channels, the Laboratory will present the
issue to the MSAG for resolution.
(5) MSD sends the final official version of the certificate for printing
and posts it to the SRM website. Copies of the final certificate
and MSDS are sent by the Documentation and Quality Services Group to the
Materials and Physical Services Group of MSD to be included with each SRM
shipped.
(6) As the draft certificate is being reviewed, MSD prepares and submits
to the Budget Division for review and approval of Form NIST-206, Standard
Reference Material Transfer Notice (STN), to price the SRM (see Section
5.19.07 on cost recovery). MSD sends final approved STNs to the Finance
Division to credit the SRM production project and debit the SRM finished
goods project in the NIST accounting system.
(7) All technical and financial documentation and information pertaining
to each SRM is maintained in MSD in an information folder, called the “R”
folder.
k. Material packaging, distribution, and storage
(1) An inventory supply sufficient to meet current customer demand is
packaged and labeled by MSD. Remaining inventory from a batch is
bottled or ampouled and stored at proper conditions to be labeled
for future sale.
(2) Most materials are stored by MSD; however, material having special
storage requirements may be stored by the technical division.
(3) Orders are shipped by MSD to the customer, except radioactivity
SRMs that are shipped directly from the technical division.
l. Marketing and sales
(1) SRMs are announced via the SRM website, the SRM quarterly newsletter
and the NIST SRM Catalog (NIST SP-260), among other means.
(2) MSD logs completed SRMs into the SRM sales and inventory system
which maintains detailed sales transaction histories by SRM.
(3) Customer orders are received by MSD via telephone, fax, or on-line.
(4) Each SRM sold is carefully packaged with documentation containing
assigned values with stated uncertainties and a MSDS, if applicable.
Details on use, stability, and NIST analytical methods are also included.
m. Stability testing
(1) Stability testing is conducted by each Laboratory on units already
in inventory for which deterioration is expected to occur.
(2) Laboratory technical staff determines which SRMs will require stability
testing in the following year and the amount of funding necessary to support
the work.
(3) A memorandum from the Budget Division initiates the formal process
of consolidating Laboratory stability testing funding requirements.
Stability testing funding requirements by SRM are submitted by the Laboratory
to the Budget Division with a copy to MSD.
(4) The Budget Division reviews the stability testing funding requirements
with input from MSD, allocates stability testing funding to the Laboratories,
and sets the annual stability testing rates.
n. Information and policy management
(1) MSD provides the necessary information and reports to assist technical
staff and management in making SRM decisions.
(2) MSD provides policy guidance and maintains policies
and procedures related to SRMs.
(3) MSD refers policy issues requiring attention to the
MSAG for resolution.
5.19.07
COST RECOVERY AND PRICING
The following describes the components of the SRM sales price which
complies with Office of Management and Budget (OMB) Circular A-25 requiring
full cost recovery. All NIST-wide surcharges must be applied to the
SRM price, and any change in fee policies must be justified in writing
to the Congress (15 U.S.C. 278i(b)).
Based on (i) the full production costs, (ii) the estimated number-of-years supply the units represent, and (iii) the basis for the estimate provided by the Laboratory technical staff, MSD prepares an SRM Transfer Notice (STN) (NIST-206) to price the SRM as follows:
Unit Production Cost (UPC)
+ Other Factors, if applicable
+ MSD SRM Operations surcharge (dollar fee
+ Service Development surcharge (percent of UPC)
+ Obsolescence surcharge (percent of UPC)
+ Stability testing surcharge, if applicable (dollar fee)
+ Use surcharge (dollar fee)
+ Replacement surcharge (percent of UPC)
= SRM unit selling price (rounded to nearest dollar)
a. Unit production cost (UPC) (NIST Working Capital Funds and other federal government agency funds and services)
(1) All actual Laboratory and MSD WCF production labor and material
costs related to each SRM are recovered through the NIST Unit Production
Cost component of the SRM price.
(2) SED’s statistical services expenses are also recovered in the NIST
UPC cost calculation. An amount equal to a predetermined percentage,
previously approved by the MSAG and the Budget Division, of the Laboratory’s
labor expenses incurred on the SRM being priced is included in the NIST
UPC.
(3) If funds or services from a federal government agency are provided
for the production of an SRM and the agreement clearly documents the other
federal government agency’s intent for NIST to sell and distribute the
units and recover the value of its funding or services provided, the total
UPC is set to recover these costs and, upon the sale of the SRM, the Finance
Division returns this portion of the sales income to the funding organization
on a quarterly basis. See Appendix B for SRM work involving federal
and non-federal government organizations.
(4) The UPC is determined by evenly distributing the total production
costs across the units being transferred to inventory.
(5) It is NIST policy to recover through sales the full production
costs in no more than five years (see Section 5.19.05c). Laboratories
are responsible for providing to MSD for pricing purposes (i) the full
production costs, (ii) the estimated number-of-years supply the units represent
and (iii) the basis for the estimate.
b. Other Factors may be considered in setting the price of an SRM, such as to collect the equivalent of the fair market value when materials or services have been donated or production costs have been fully amortized over previous batches, or to take into consideration the fair market value of precious metals.
(1) Including such values in the SRM price complies with the Statement
of Federal Financial Accounting Standards (SFFAS) Number 3, Accounting
for Inventory and Related Property, dated October 27, 1993.
(2) Other Factors income represents a profit to the SRM Program; however
15 U.S.C. 278b(f) allows NIST to apply earned net income to restore “any
prior impairment of the fund” ensuring the availability of working capital
necessary to replace SRM inventories. Therefore, Other Factors income
is applied to excess inventory write-offs, thus maintaining the SRM WCF
corpus.
c. Operations surcharge income funds the Measurement Services Division’s (MSD) administrative support and centralized business and information services activities related to SRMs.
(1) The operations surcharge is a dollar rate added to the price of
each SRM. The full operations surcharge is levied on most SRM units;
however, in some cases, the actual SRM unit surcharge applied is a fraction
or a multiple of the full surcharge, depending on the administrative work
required by MSD.
(2) The average operations surcharge rate is calculated annually by
the Budget Division based on a proposed budget submitted by MSD and estimated
SRM sales.
d. Service Development (SD) surcharge income funds the cost of resolving material and technical issues prior to receiving WCF Production funds and of developing a prototype of future SRMs.
(1) The SD surcharge is a fixed percent of each SRM’s Unit Production
Cost (UPC).
(2) The Budget Division reviews and sets the rate annually.
e. Obsolescence surcharge recovers a portion of the cost of unsold units in inventory (finished goods) that are written-off. WCF invested in the production of an SRM that yields no saleable product (failed work-in-process) is covered by Laboratory STRS (see Section 5.19.08a).
(1) The obsolescence surcharge is a fixed percent of each SRM’s UPC.
(2) The Budget Division reviews and sets the rate annually and throughout
the year reviews and approves failed work-in-process obsolescence requests
submitted by the Laboratories and finished goods obsolescence requests
submitted by MSD.
(3) Actual obsolescence reflects true losses and not losses based on
anticipated income. Actual finished goods obsolescence write-offs
in excess of obsolescence surcharge collections are offset against Other
Factors income.
f. Stability Testing surcharge income funds the cost of testing units already in inventory in which deterioration is expected to occur.
(1) The stability testing surcharge is a dollar rate added to the price
of SRMs only in those categories requiring stability testing work.
(2) The stability testing rates are set annually by the Budget Division
based on the stability testing funding requirements submitted by the Laboratories
and estimated SRM unit sales.
g. Use surcharge is levied to recover a portion of the depreciation of government buildings. See Subchapter 8.06, Expense and Income Activities, for additional information on the Use Surcharge.
(1) The application of the NIST Use surcharge to SRM customers is via
a small dollar rate set by the Budget Division based on their annual estimate
of the SRM Program’s portion of the total NIST use charge expense.
The surcharge is included in the price of the SRM.
(2) Funds collected via the Use surcharge are deposited in the general
fund of the U.S. Treasury.
h. Replacement surcharge allows NIST to raise SRM prices to ensure recovery of the current replacement value of SRM inventories.
(1) The replacement surcharge was created under the authority of the
July 29, 1985, amendment to 15 U.S.C. 278b(f).
(2) The Budget Division provides to MSD the annual inflationary factors
to be used for materials and labor. MSD then calculates the annual
replacement surcharge rate and submits it to the Budget Division for review
and approval.
(3) At the beginning of each calendar year, the prices of SRMs in inventory
for more than one year are increased by this surcharge rate.
5.19.08
NON-DELIVERED, OBSOLETED, DISCONTINUED, RESTRICTED, AND LIMITED PURCHASE
PROJECTS
a. Non-Delivery occurs when (i) a Laboratory, for whatever reason,
abandons an SRM production project that is in-process or (ii) the SRM is
not in inventory within three years of the initial production labor charges.
(1) It is the responsibility of each Laboratory to notify the Budget
Division via memorandum to close out abandoned in-process production work.
(2) The Budget Division will notify the Chair of the MSAG annually
of projects approaching or exceeding the three-year limit. The Chair
of the MSAG will then consult with the appropriate Laboratory on the status
of such projects and report back to the Budget Division on the action to
be taken and the reason for the action.
(3) A Laboratory may submit in writing to the MSAG a request for additional
time to complete an SRM.
(4) A Laboratory may appeal in writing to the MSAG for a waiver of
the requirement to pay back the WCF for non-delivery of an SRM. The
MSAG reviews and votes on the appeal. An MSAG quorum is two-thirds
of its members and a successful appeal requires at least three-quarters
voting in favor of the appeal. The decision of the MSAG on all appeals
is final. In the event of a successful appeal, the loss is covered
using Other Factors income (see Section 5.19.07b).
(5) If non-delivery occurs and there is no waiver of the pay back requirement,
the Laboratory is responsible for repaying the amount of WCF invested in
the SRM with its STRS funds over a two-year period including any replacement
surcharges that have been applied to SRM inventories since the WCF resources
were borrowed.
b. Obsoleted SRMs are SRMs in finished goods inventory that are broken, spoiled or degraded beyond a useful point, technologically obsolete, or more than a reasonable supply exists based on average historical sales, projected sales, possible future technical obsolescence, or dollar amount invested.
(1) MSD works with each Laboratory annually to identify finished goods
inventory to be written-off considering criteria such as the size of the
user community, if the SRM is no longer a technical priority of the Laboratory,
the amount of WCF resources tied up in the material, and the cost of storage
and inventory testing.
(2) The review of finished goods inventory will also include SRMs that
have not recovered the full amount of WCF invested within five years of
going into inventory to determine the reason, if possible (i.e. new technology
or legislative change), as well as if the material should be considered
for obsolescence.
(3) MSD then presents to the MSAG a consolidated listing of all finished
goods inventory eligible for obsolescence ranked based on the criteria
above and recommends which projects warrant obsolescence in the current
fiscal year.
(4) Upon MSAG approval of the finished goods obsolescence, MSD submits
a memorandum to the Budget Division identifying by SRM the number of units,
the amount to be written-off, and the reason for the obsolescence.
(5) The Obsolescence surcharge and Other Factors income are used to
offset the cost of finished goods obsolescence.
(6) A Laboratory may opt to use its STRS to buy out finished goods
inventory to free up funds in its SRM WCF account. Such requests
are sent to the Budget Division.
c. Discontinued SRMs are SRMs that a Laboratory decides not to renew.
(1) A Laboratory communicates to MSD in writing its decision to discontinue
an SRM along with the reason for the decision. MSD then notes in
the SRM catalog and other marketing material that the SRM will not be renewed
once remaining stock is depleted. If alternate sources of equivalent
standards are identified, MSD staff will inform customers, as appropriate
for referring customers to private sector vendors.
(2) If a Laboratory determines that remaining stock of a discontinued
SRM should be removed from inventory, the Laboratory also communicates
this to MSD. The value of this inventory is obsoleted and the provisions
and process in section b above pertain.
d. Restricted SRMs are SRMs in stock but temporarily unavailable for sale to customers because a technical issue has been identified.
(1) Customers contact Laboratory staff directly concerning technical
issues related to SRMs. Laboratory staff then communicates to MSD
any technical issues that warrant placing an SRM on restriction so that
MSD can update the SRM sales and inventory system and website.
(2) MSD also places on restriction SRMs with approaching certificate
expiration dates and notifies the Laboratory staff so that the certification
date can be extended or the units can be obsoleted.
e. Limited purchase SRMs are SRMs in stock for which the number of units one customer may purchase is limited to ensure measurement traceability is distributed throughout the scientific community as much as possible.
(1) Laboratory staff, in consultation with MSD, is responsible for determining
that it is necessary to limit the number of units a customer may purchase
at a given time.
(2) Laboratory and MSD staff work to establish the appropriate limitation
considering the estimated supply available, perpetuation plan, and stability
of the units.
(3) Limitations must be equitable among customers and may differentiate
among SRMs.
5.19.09
DEFINITIONS
a. Certified Reference Material (CRM) – Reference material,
accompanied by a certificate, one or more of whose property values are
certified by a procedure which establishes traceability to an accurate
realization of the unit in which the property values are expressed, and
for which each certified value is accompanied by an uncertainty at a stated
level of confidence. (ISO International Vocabulary of Basic and General
Terms in Metrology (VIM): 1993)
b. Reference Material (RM) – Material or substance one or more of whose property values are sufficiently homogeneous and well established to be used for the calibration of an apparatus, the assessment of a measurement method, or for assigning values to materials. (ISO VIM: 1993)
c. Reference Material Certificate – Document accompanying a certified reference material stating one or more property values and their uncertainties, and confirming that the necessary procedures have been carried out to ensure their validity and traceability. (ISO Guide 30: 1992)
d. NIST Standard Reference Material® (SRM®) – A CRM issued by NIST that also meets additional NIST-specific certification criteria and is issued with a certificate or certificate of analysis that reports the results of its characterizations and provides information regarding the appropriate use(s) of the material (NIST SP 260-136). Note: An SRM is prepared and used for three main purposes: (1) to help develop accurate methods of analysis; (2) to calibrate measurement systems used to facilitate exchange of goods, institute quality control, determine performance characteristics, or measure a property at the state-of-the-art limit; and (3) to ensure the long-term adequacy and integrity of measurement quality assurance programs. The terms “Standard Reference Material” and “SRM,” and the diamond-shaped logo which contains the term “SRM,” are registered with the United States Patent and Trademark Office.
e. NIST Reference Material – Material issued by NIST with a report of investigation instead of a certificate to: (1) further scientific or technical research; (2) determine the efficacy of a prototype reference material; (3) provide a homogeneous and stable material so that investigators in different laboratories can be ensured that they are investigating the same material; and (4) ensure availability when a material produced and certified by an organization other than NIST is defined to be in the public interest or when an alternate means of national distribution does not exist. A NIST RM meets the ISO definition for a RM and may meet the ISO definition for a CRM (depending on the organization that produced it).
f. NIST Traceable Reference MaterialTM (NTRMTM) – A commercially-produced reference material with a well-defined traceability linkage to existing NIST standards for chemical measurements. This traceability linkage is established via criteria and protocols defined by NIST to meet the needs of the metrological community to be served (NIST SP 260-136). Reference materials producers adhering to these requirements are allowed use of the NTRM trademark. A NIST NTRM may be recognized by a regulatory authority as being equivalent to a CRM.
g. NIST Certified Value – A value reported on an SRM certificate or certificate of analysis for which NIST has the highest confidence in its accuracy in that all known or suspected sources of bias have been fully investigated or accounted for by NIST. (NIST SP 260-136)
h. NIST Reference Value – A best estimate of the true value provided on a NIST certificate, certificate of analysis, or report of investigation where all known or suspected sources of bias have not been fully investigated by NIST. (NIST SP 260-136)
i. NIST SRM Certificate or Certificate of Analysis – In accordance with ISO Guide 31: 2000, a NIST SRM certificate is a document containing the name, description, and intended purpose of the material, the logo of the U.S. Department of Commerce, the name of NIST as a certifying body, instructions for proper use and storage of the material, certified property value(s) with associated uncertainty(ies), method(s) used to obtain property values, the period of validity, if appropriate, and any other technical information deemed necessary for its proper use. A Certificate is issued for an SRM certified for one or more specific physical or engineering performance properties and may contain NIST reference, information, or both values in addition to certified values. A Certificate of Analysis is issued for an SRM certified for one or more specific chemical properties. Note: ISO Guide 31 is updated periodically; check with ISO for the latest version.
j. NIST Certificate of Traceability – Document stating the purpose, protocols, and measurement pathways that support claims by an NTRM to specific NIST standards or stated references. No NIST certified values are provided, but rather the document references a specific NIST report of analysis, bears the logo of the U.S. Department of Commerce, the name of NIST as a certifying body, and the name and title of the NIST officer authorized to accept responsibility for its contents.
k. NIST RM Report of Investigation – Document issued with a NIST RM that contains all the technical information necessary for proper use of the material, the logo of the U.S. Department of Commerce, and the name and title of the NIST officer authorized to issue it. There are no NIST certified values provided, and authorship of a report’s contents may be by an organization other than NIST.
l. NIST Report of Analysis (ROA) – Document containing the certification of the material and including such information as the base material used, how the SRM was manufactured, the certification method(s) and description of procedures, outside collaborators, instructions for use, special instructions for packaging, handling, and storage, and plan for stability testing. The ROA is intended for internal NIST use only.
m. Costs on the Books/Work-in-Process – The amount of NIST Working Capital funds invested in an SRM for which transfers to stock and production costs remain.
n. Measurement Services Advisory Group (MSAG) – Comprised of
the Directors of each NIST Laboratory and Technology Services, or their
designees. The MSAG (i) establishes policies related to measurement
services to ensure consistent practices across NIST while preserving the
independence of each Laboratory’s SRM activities as much as possible, and
(ii) resolves matters that relate to more than one NIST Laboratory.
5.19.10
REFERENCES
a. NIST is authorized to conduct SRM activities through the National
Institute of Standards and Technology Act (15 U.S.C. 272(c)).
b. Cost Recovery
(1) Authority to charge fees for SRMs is granted in sections 275a and
275c of the National Institute of Standards and Technology Act (15 U.S.C.
275).
(2) The Office of Management and Budget (OMB) Circular A-25 establishes
federal policy regarding fees assessed for the “sale or use of Government
goods or resources” and provides the basis for setting those fees, which
must be sufficient enough to recover full costs. In addition, A-25
requires a biennial review of fees; however, it is NIST policy to review
fees annually.
c. Earned Net Income and Inventory Replacement Costs
15 U.S.C. 278b(f) requires NIST to return to the general fund of the Treasury “any earned net income” at the end of each fiscal year and, as amended on July 29, 1985, allows NIST to recover and retain as earnings the current replacement value of its SRM inventories.
d. Changes in Policies
15 U.S.C. 278i(b) requires that all changes in policies regarding fees for SRMs, except changes due to the costs of raw materials or of producing and delivering SRMs, be justified in writing by the NIST Director to the Congress.
e. Code of Federal Regulations (CFR)
(1) 15 CFR 200.104 provides the purpose of the NIST SRM Program.
(2) 15 CFR 230 provides general information and purchase procedures
for NIST SRMs.
f. NIST Administrative Manual
(1) Subchapter 8.05 contains procedures for other-agency sponsored work.
(2) Subchapter 8.06 contains appropriate charges for Expense and Income
(E&I) activities at NIST which include SRM surcharge-supported activities
such as service development and operations.
(3) Subchapter 8.07 provides an explanation of the NIST Working Capital
Fund (WCF), including SRM production activities and procedures for producing
SRMs on demand.
g. SRM Catalog and Price List
(1) The SRM Catalog (NIST SP-260) is issued every two to three years
and provides technical descriptions for all available NIST SRMs and RMs.
(2) The SRM Price List is a supplement to the SRM Catalog, is issued
annually, describes ordering procedures, and lists current prices for NIST
SRMs and RMs, including those materials that have become available since
the last catalog edition was issued.
h. The SRM Website, available at http://www.nist.gov/srm, contains the SRM Catalog and Price List, as well as on-line ordering information, a listing of newly introduced SRMs, and important standards related links.
i. The SRM Reporting website available at http://tsapps-i.nist.gov/srmreport/ contains current and historical SRM sales and inventory data available to internal NIST staff.
