FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.5.6

Revision #: 02

Revised:

05/15/2019

Title: 

Traceability Page 1 of 9

For the most current and official copy, check QMiS.

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.
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.5.6

Revision #: 02

Revised:

05/15/2019

Title: 

Traceability Page 2 of 9

For the most current and official copy, check QMiS.

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 
FOOD AND DRUG ADMINISTRATION

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ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.5.6

Revision #: 02

Revised:

05/15/2019

Title: 

Traceability Page 3 of 9

For the most current and official copy, check QMiS.

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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ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.5.6

Revision #: 02

Revised:

05/15/2019

Title: 

Traceability Page 4 of 9

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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 
FOOD AND DRUG ADMINISTRATION

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ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.5.6

Revision #: 02

Revised:

05/15/2019

Title: 

Traceability Page 5 of 9

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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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ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.5.6

Revision #: 02

Revised:

05/15/2019

Title: 

Traceability Page 6 of 9

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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 
FOOD AND DRUG ADMINISTRATION

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ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.5.6

Revision #: 02

Revised:

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Title: 

Traceability Page 7 of 9

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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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ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.5.6

Revision #: 02

Revised:

05/15/2019

Title: 

Traceability Page 8 of 9

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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*

(D, I, R) Date Author Name and Title Approving Official Name and Title

1.2 R 11/16/05 LMEB LMEB
FOOD AND DRUG ADMINISTRATION

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ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.5.6

Revision #: 02

Revised:

05/15/2019

Title: 

Traceability Page 9 of 9

For the most current and official copy, check QMiS.

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

02 Revisions made to align this procedure with new ISO/IEC 17025 and AOAC 

requirements. Revision to formatting and policy clarifications were also made.

12. Attachments

None