FOOD AND DRUG ADMINISTRATION Document Number:

Revision #: 02
OFFICE OF REGULATORY AFFAIRS Revised:
ORA-LAB.5.6
ORA Laboratory Manual Volume II 05/15/2019

Title:
Page 1 of 9
Traceability

Sections in This Document

1. Purpose ....................................................................................................................................1
2. Scope .......................................................................................................................................1
3. Responsibility............................................................................................................................2
4. Background...............................................................................................................................2
5. References ...............................................................................................................................2
6. Procedure .................................................................................................................................2
6.1. Measurement Traceability ..............................................................................................2
6.2. Traceability Alternatives to SI Units ...............................................................................3
6.3. Calibration and Calibration Services for Reference Standards ......................................4
6.4. Reference Materials .......................................................................................................4
6.5. Reagents, solvents, gases, and media ..........................................................................5
6.6. Disposal .........................................................................................................................6
7. Glossary/Definitions ..................................................................................................................6
8. Records ....................................................................................................................................8
9. Supporting Documents .............................................................................................................8
10. Document History .....................................................................................................................8
11. Change History .........................................................................................................................9
12. Attachments ..............................................................................................................................9

1. Purpose
To provide guidelines for the establishment and maintenance of metrological
traceability of measurement results by means of a documented unbroken
chain of calibrations, each contributing to the measurement uncertainty, linking
them to an appropriate reference.

2. Scope
This procedure describes how the Office of Regulatory Science (ORS)
laboratories achieve measurement and/or metrological traceability for their
measuring and testing equipment, as well as for its reference standards,
materials, and media.

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 FOOD AND DRUG ADMINISTRATION Document Number:
Revision #: 02
OFFICE OF REGULATORY AFFAIRS Revised:
ORA-LAB.5.6
ORA Laboratory Manual Volume II 05/15/2019

Title:
Page 2 of 9
Traceability

3. Responsibility
ORA laboratories are responsible for maintaining records of measurement and
metrological traceability. These records include, but are not limited to, the
calibration and verification of equipment such as balances, pipettes, and
thermometers. Records also must include the certificates for reference
standards and materials used to calibrate laboratory equipment and for
reference cultures.

4. Background
None

5. References
A. ISO/IEC 17025:2017, General requirements for the competence of
testing and calibration laboratories, Section 6.5 & Annex A
(Informative): Metrological Traceability.
B. ISO 17034, General requirements for the competence of reference
material producers.
C. AOAC International Guidelines for Laboratories Performing
Microbiological and Chemical Analysis of Food, Dietary Supplements,
and Pharmaceuticals – An Aid to Interpretation of ISO/IEC 17025:2017;
August 2018.
D. EURACHEM/CITAC guide Traceability in Chemical Measurement – A
guide to achieving comparable results in chemical measurement
E. ILAC Policy on Traceability of Measurement Results

6. Procedure
6.1. Measurement Traceability
A. Reference balance mass units, thermometers and thermocouples are
traceable to International Standard (SI) units of measurement.
Calibration laboratories providing these reference standards that
conform to and are accredited to ISO 17025:2017 provide metrological
traceability with their certificates.
B. Laboratory measuring equipment is calibrated or standardized using
materials of known and acceptable purity (i.e. neat compounds, or

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Revision #: 02
OFFICE OF REGULATORY AFFAIRS Revised:
ORA-LAB.5.6
ORA Laboratory Manual Volume II 05/15/2019

Title:
Page 3 of 9
Traceability

reference materials of know composition traceable to national,

international or equivalent standards). Uncertainty contributions are
addressed in ORA-LAB.5.4.6. Estimation of Uncertainty of
Measurement.
Certified values of certified reference materials from reference material
producers conforming to ISO 17304 provide metrological traceability.
C. Media are verified against national or international standards (i.e.
reference cultures or certified reference cultures).
D. The traceability to SI units is achieved by reference to national
measurement standards that are primary realizations of the SI units or
agreed representations of SI units. SI units are based on fundamental
physical constants of mass, distance, and time.
E. Traceability may also be established through secondary standards that
are calibrated by a national metrology institute such as the National
Institute for Standards and Technology (NIST).
6.2. Traceability Alternatives to SI Units
A. Where calibrations cannot provide traceability to SI units, confidence in
measurements is established with traceability to measurement
standards such as:
1. certified reference materials provided by a competent supplier to
give a reliable physical or chemical characterization of a material,
and
2. the use of specified methods and consensus standards that are
clearly described and agreed to by the parties concerned.
B. Where traceability of measurements to SI units is not possible or not
needed, the same requirements for traceability, for example, certified
reference materials, agreed methods or consensus standards are
needed.
C. For some analyses certified reference materials are not readily found.
In this case, a material with similar properties and stability is selected.
The properties of interest in this material are characterized by repeat
testing, preferably by more than one laboratory and using a variety of
methods.
D. Where national or international standards are not found for the
verification of the performance of microbiology procedures, the
laboratory records recovery by either participating in a program of
interlaboratory comparison or proficiency testing, use of reference

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Title:
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Traceability

cultures or certified reference cultures, or by a mutual agreement with

client on expectations.
E. In cases where a Reference material is made in-house the laboratory
should comply with ISO 17034 General Requirements for the
competence of reference material producers.
6.3. Calibration and Calibration Services for Reference Standards
A. Laboratory reference standards (i.e. weights, thermometers, etc.) are
calibrated by an accredited calibration laboratory that can provide the
laboratory with certificates of calibration linking the calibrations to
measurements made by NIST or some equivalent. The identity of the
calibration laboratory is included on the certificate as well as the
methods and standards primary to the process.
B. Traceable reference thermometers and thermocouples are calibrated
every two years, and reference mass units are calibrated every five
years. Frequency of other reference standards is documented in
laboratory procedures.
C. Reference standards are used for calibration verification only and not as
working standards.
D. A calibration certificate bearing an accreditation body logo from a
calibration laboratory accredited to ISO/IEC 17025 for the calibration
concerned is sufficient evidence of traceability of the calibration data
reported. NOTE: the calibration laboratories must be accredited to
ISO/IEC 17025:2017 after August 2020.
E. The date of calibration is included for the reference standard in the
calibration certificates.
F. These reference standards are stored in a protected area to prevent
any damage that would invalidate their use.
G. Servicing is requested from an accredited calibration laboratory when
data acceptance criteria for verification are not met and the analyst is
unable to implement a corrective action.
6.4. Reference Materials
A. Reference materials are to be traceable to SI units of measurement, to
standard reference materials (SRMs), certified reference materials
(CRMs), certified reference cultures (CRCs) and obtained from
reference material providers accredited to ISO 17034 when possible.
B. In microbiology, the organisms required for the tests shall be verified,
stored appropriately, checked for purity and demonstration of

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Title:
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Traceability

biochemical or other biological characteristics, as appropriate for their

application.
C. The organisms are traceable and documented from date of possession.
D. Manufacturer’s Certificates of Analysis are retained for reference
materials used.
E. A listing of reference materials in use in the laboratory is maintained.
This listing contains, as a minimum, the chemical name or description,
source, manufacturer’s lot number, unique laboratory identification
number (if lot number not used), date of receipt, manufacturer’s
expiration date if available or laboratory determined expiration date,
open date when open date impacts expiration date, and traceability to
person assuming responsibility for the reference material.
F. Reference materials are labeled using an identification scheme that
allows the laboratory to trace the lot used in any analysis, date of
receipt and initials, date opened and initials, and expiration date.
G. Analytical records include the identity of and the measurement values
for reference materials used in the routine analyses. This information
provides traceability to the measurements for batches of samples
measured sequentially to the reference material. This information is
recorded in the analytical worksheets, instrument logbooks or
incorporated in the instrument print out for the analyses.
H. Calibration of instruments is verified during the performance of
analyses. The frequency of calibration is identified in the test method or
per laboratory instrument procedure.
I. The safe handling, transport, storage, and use of laboratory reference
materials are conducted according to the manufacturer’s instructions in
order to prevent contamination, deterioration, and to protect their
integrity.
J. Reference materials are not used past their expiry date without
documented requalification demonstrating they are still suitable for use.
K. Reference materials with an expiration date of only month and year will
expire on the last day of the month.
L. Reference materials are not stored with samples.
6.5. Reagents, solvents, gases, and media
A. For most analyses, analytical reagent grade is satisfactory. Trace
analyses frequently call for special ultra pure reagents, solvent and
gases.

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Title:
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Traceability

B. Reagent grade chemicals should be ordered in quantities such that the

supply will be consumed within the manufacturer’s expiration date or 5
years, whichever is first.
C. Chemicals and solvents with an expiration date of only month and year
will expire on the last day of the month.
D. For extended use of purchased laboratory reagents and solutions
without a "use by" or expiry date provided by the manufacturer, an
assessment will be conducted (literature review may be acceptable) of
that specific chemical's or chemical family's stability and a "use by" or
expiry date be determined. The determined "use by" or expiry dates are
documented.
E. All reagents, solutions and media are labeled with date of receipt and
initials, date opened or prepared and initials, and expiration date.
F. Reagents, solvents, gases, and media are stored according to the
manufacturer’s directions and are not kept longer than recommended
by the manufacturer or the method. Reagents are checked for signs of
deterioration. Reagents that have deteriorated are not used and are
discarded in accordance with a Laboratory’s Safety and Hazardous
Waste procedures.
G. Media purchased or prepared are evaluated for suitability.
6.6. Disposal
Reference materials, reagents, solvents, gases, and media are disposed of
according to federal, state and local regulations. The laboratory has
procedures for the proper disposal.

7. Glossary/Definitions
A. Calibration – A calibration is the set of operations which establish, under
specified conditions, the relationship between values indicated by a
measuring instrument or measuring system, or values represented by a
material measure, and the corresponding known values of known
values of a measurand.
B. Calibration laboratory - a calibration laboratory provides calibration
services as its principal activity. This type of laboratory is also
referenced as a metrology laboratory.
C. Certificate of Analysis – a document issued by the Quality Assurance
section of a manufacturer that confirms a product meets its product
specification. They commonly contain the actual results obtained from

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Title:
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Traceability

testing performed as part of quality control of an individual batch or

product and include Measurement Uncertainty information.
D. Certified reference cultures (CRC) – These are cultures traceable to
nationally or internationally recognized type culture collection (i.e.
American Type Culture Collection).
E. Certified reference material (CRM) – A material with one or more
property values certified by a technical valid procedure, accompanied
by or traceable to a certificate or other documentation that is issued by
a certifying body.
F. International standard – These are standards from an international
repository that fulfill the properties of primary standards for the
realization of SI units.
G. ISO 17034 - specifies general requirements in accordance with which a
reference material producer has to demonstrate that it operates, if it is
to be recognized as competent to carry out the production of reference
materials.
H. Logbook – Record containing specified information. There is no
requirement that the logbook be a bound notebook or in a binder.
Records may be kept electronically.
I. Measurand – A measurand is a particular quantity subject to
measurement.
J. Measuring and testing equipment – These are devices used by the
laboratory for testing and measurement. Equipment, instruments, and
instrumentation are terms used synonymously with measuring and
testing equipment.
K. National Standard – These standards are from a national repository that
fulfills the properties of primary standards for the realization of SI units.
L. NIST – National Institute of Standards and Technology – Nationally
recognized measurement body for the United States.
M. Reference Material (RM) – a material with one or more property values
sufficiently well established to be used for calibration (standardization)
of an apparatus, the assessment of a measurement method, or for
assigned values to materials; sometimes referred to as Standard
Reference Material (SRM).
N. Reference Standard – a standard with generally the highest
metrological quality available at a given location in an organization, from
which measurements made there are derived. Generally, this refers to

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Title:
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recognized national or international traceable standards such as NIST

thermometers and weights.
O. Standardization – This is the assignment of a compositional value to
one standard (measurand) based upon another standard.
P. Traceability – Traceability is an unbroken chain of calibrations or
comparisons to identified primary standards of the SI units of
measurement.
Q. Verification – Verification is confirmation by examination and provision
of evidence that specified requirements have been met.

8. Records
A. Certificates of calibration for Reference standards
B. Certificates of analysis for Reference materials
C. Inventory of Reference Materials and Reference Cultures
D. Reference Material logbooks
E. Reference material expiration extensions
F. Assessments and/or literature used for assessments for laboratory
determined expiry dates

9. Supporting Documents
A. ORA Laboratory Manual, Volume II
B. ORA Laboratory Manual, Volume II, ORA-LAB.5.5 Equipment
C. Laboratory Hazardous Waste Management Plan
D. Laboratory Chemical Management Plan
E. Microbiology Laboratory media procedure for preparation, labeling and
quality control

10. Document History

Revision Status* Approving Official Name
Date Author Name and Title
# (D, I, R) and Title
1.2 R 11/16/05 LMEB LMEB

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ORA-LAB.5.6
ORA Laboratory Manual Volume II 05/15/2019

Title:
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Traceability

1.3 R 12/06/06 LMEB LMEB

02 R 05/15/2019 LMEB LMEB

* - D: Draft, I: Initial, R: Revision

11. Change History

Revision
Change
#
Revisions made to align this procedure with new ISO/IEC 17025 and AOAC
02
requirements. Revision to formatting and policy clarifications were also made.

12. Attachments
None

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