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ORA Laboratory Manual Volume II

Document Number:

ORA-LAB.5.5

Revision #: 02

Revision Date:

06/06/2019

Title: 

Equipment Page 1 of 15

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Sections in This Document

1. Purpose ....................................................................................................................................1

2. Scope .......................................................................................................................................1

3. Responsibility............................................................................................................................2

4. Background...............................................................................................................................2

5. References ...............................................................................................................................2

6. Procedure .................................................................................................................................3

6.1. Equipment Identification and Records ...........................................................................3

6.2. Equipment Qualification .................................................................................................4

6.3. Equipment Maintenance and Intermediate Performance Checks..................................4

6.4. Equipment Calibration or Verification.............................................................................5

6.5. Out of Service Equipment ..............................................................................................5

6.6. Equipment Leaving Direct Control of the Laboratory .....................................................6

6.7. Handling, Use, Storage and Transport of Equipment ....................................................7

7. Glossary/Definitions..................................................................................................................8

8. Records ....................................................................................................................................9

9. Supporting Documents .............................................................................................................9

10. Document History ...................................................................................................................10

11. Change History.......................................................................................................................10

12. Attachments............................................................................................................................10

Attachment A - Equipment Requirements ..............................................................................11

1. Purpose 

This procedure specifies the schedule and requirements for maintenance, 

performance, calibration, and verification of laboratory testing equipment to 

ensure compliance with ISO/IEC 17025:2017 and AOAC requirements. 

Meeting the criteria in this procedure demonstrates control of the equipment 

maintenance and calibration parameters needed to achieve accurate test 

results.

2. Scope

These procedures apply to the analytical testing equipment used by the Office 

of Regulatory Science (ORS) laboratories.
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3. Responsibility 

A. Laboratory Management

1. Ensures the laboratory is equipped with equipment that meets the 

specifications of the analytical methods used.

2. Ensures equipment maintenance and calibrations are conducted.

3. Provides support for arranging non-routine instrument repair and 

ordering replacement instrument parts.

4. Designates equipment monitors.

B. Assigned Monitors

1. Maintains equipment logbooks

2. Performs periodic equipment checks

3. Ensures equipment is maintained in accordance with their respective 

requirements.

C. The Quality Management System Manager 

1. Ensures monitoring of equipment records.

2. Ensures laboratory equipment is calibrated and maintained in 

accordance with accreditation requirements.

D. Staff

1. Verifies equipment conforms to specifications prior to use.

2. Completes the record of this verification.

3. Adheres to written equipment operation procedures.

4. Background 

None

5. References 

A. ISO/IEC 17025:2017, General requirements for the competence of 

testing and calibration laboratories Section 6.4

B. AOAC International Guidelines for Laboratories Performing 

Microbiological and Chemical Analysis of Food, Dietary Supplements, 
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and Pharmaceuticals – An Aid to Interpretation of ISO/IEC 17025:2017; 

August 2018.

C. FDA Staff Manual Guide (SMG) 2620.2, Procedure for surplus 

equipment

6. Procedure 

6.1. Equipment Identification and Records 

A. All equipment in the FDA equipment inventory system is labeled with a 

unique identification number (e.g. FDA bar code number). Generally, 

equipment not bar coded under the FDA-wide inventory system is 

identified under the laboratory's own unique numbering system.

B. Each laboratory maintains an inventory of its major equipment used to 

perform regulatory testing. This inventory contains the following 

information:

1. Item and its software version, 

2. Manufacturer and model,

3. Serial number or other unique identification, and

4. Location

C. The label or tag found on or near the equipment contains the following 

information:

1. FDA bar code or unique identification number,

2. Date of last calibration, and

3. Date of the next calibration. 

D. Equipment that is scheduled to be calibrated daily or with each use, is 

tagged as above, except that instead of the calibration dates, it is 

annotated as such (e.g. calibrated daily or calibrated with each use).

E. Small items with insufficient space to record the information on the label 

(e.g. thermometers) need only be identified with their unique 

identification number for traceability to their associated records. 

F. Detailed guidance on equipment records is provided in ORA-LAB.5.5.1. 

Equipment Records.
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6.2. Equipment Qualification

A. When new equipment is installed, laboratories may elect to purchase 

Installation Qualification (IQ) and Operation Qualification (OQ) from the 

manufacturer or installer. This information is kept with the equipment 

records. 

B. Alternatively, for new equipment the laboratory may determine 

independently that quality assurance specifications have been met. 

C. Equipment is not used until it has been qualified and users have been 

trained in its operation.

6.3. Equipment Maintenance and Intermediate Performance Checks

A. Laboratory equipment maintenance and intermediate performance 

checks are conducted on a scheduled basis. A schedule, identifying and 

eliminating potential sources of problems, is established for the 

servicing of laboratory equipment. 

Note: Intervals of intermediate performance checks should be shorter 

than the time the equipment has been found to take to drift outside 

acceptable limits.

B. Such maintenance and performance checks are recorded to 

demonstrate that the program is being followed according to schedule.

C. Manufacturer’s instructions are used for guidance in performing 

equipment maintenance. In the absence of manufacturer’s instructions, 

instructions are provided in the equipment operation procedure. 

D. The maintenance and performance checks records may be maintained 

in a logbook, log sheet, or electronically.

E. Attachment A provides information on minimum maintenance 

requirements for equipment according to AOAC-International. ORS 

laboratories are responsible for developing comparable maintenance 

schedules for equipment not listed in this table.

F. Preventative maintenance procedures, other than basic cleaning, are 

developed for each equipment item, unless they are already described 

elsewhere (e.g. the instrument manual).

G. General Service equipment is typically maintained only with cleaning 

and safety checks. 

H. Use of outside contractors to perform repairs or maintenance is at the 

discretion of local laboratory management. 
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6.4. Equipment Calibration or Verification

A. A calibration or verification procedure is prepared by the testing 

laboratory for all critical laboratory equipment where laboratory 

personnel perform the testing. If the procedure is described in an 

operators manual or a test procedure, this can be referenced in lieu of 

preparing a separate procedure.

B. Calibration or verification records are maintained. See ORA-LAB.5.5.1.

C. Minimum calibration or verification schedules according to AOAC 

International for the most common types of laboratory equipment are 

found in Attachment A. For analytical equipment not listed, the 

laboratory must develop a comparable schedule.

D. Generally, laboratory equipment is categorized as follows:

1. General service equipment such as blenders, ovens, hotplates, 

furnaces, stirrers;

2. Volumetric equipment such as Class A glassware, mechanical and 

automatic pipettes and burets; Note: A manufacturer’s certificate of 

graduation accuracy for Class A glassware may be accepted. Other 

volumetric equipment, including mechanical and automatic pipettes 

and burets, are calibrated by the laboratory’s procedure.

3. Measuring instruments such as balances, chromatographs, 

spectrometers, thermometers; and

4. Physical standards such as reference weights and reference 

standards.

E. Data acquired on equipment which fails a parameter are investigated to 

include items between the failing assessment date and the last 

successful calibration or verification date. The problems and 

investigation are conducted according to the laboratory’s procedures for 

managing nonconforming work and corrective actions.

6.5. Out of Service Equipment

A. Equipment that is not in use, and therefore has not been calibrated, 

verified, or not operating properly must be clearly tagged out of service.

B. Out of service equipment must be calibrated or verified prior to use.

C. Equipment is not returned to service until performance checks and 

verification have been performed and recorded. An exception may be 

made if the equipment failure is not directly related to its analytical 

function, such as a problem with peripheral equipment. For example, if 
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a printer or computer attached to a chromatographic system is out of 

order, performance checks and verification for the chromatograph may 

not be needed following repair. 

6.6. Equipment Leaving Direct Control of the Laboratory

A. When, for whatever reason, i.e. repair or calibration, equipment goes 

outside the direct control of the laboratory, the laboratory shall ensure 

that the function and calibration status of the equipment and its software 

are checked and shown to be satisfactory before the equipment is 

returned to service.

1. For equipment returned after repair, the performance checks and 

calibration identified in Attachment A are conducted prior to use and 

recorded to be within specifications. 

2. For equipment returned after calibration, the contractor/vendor 

calibration certificates are reviewed for the following to ensure the 

calibration status:

a. A statement of conformity to relevant specification after 

calibration/verification, Note: such as the manufacturer’s 

specifications 

b. Item name, type, or description, 

c. Identification number, 

d. Location,

e. Calibration interval,

f. Calibration procedure used, 

g. Calibration source (both the standard used and the lab providing 

the service), 

h. Date of calibration, 

i. Corrections, conditions of use (including environmental 

conditions) necessary to achieve the required performance, 

j. Specific results of each calibration, prior to adjustment or repair, 

if the item was found out of tolerance, 

k. Details of any maintenance such as servicing, adjustments, 

repairs or modifications carried out, 

l. Any limitations on use,

m. Identification of person(s) performing the calibration,
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n. Where the accuracy of an item is described in a calibration report 

or certificate, there must be a means of traceability between that 

item and the report or certificate.

NOTE: The records may be maintained by approved calibration 

suppliers as part of their services but must remain accessible upon 

request. Electronic records may be used in lieu of paper calibration 

certificates.

3. Additionally, any equipment returned after calibration must be 

checked for functionality by performing a check of the operation of 

the equipment. For example, a pipette check would be to 

demonstrate that the pipette draws up a volume of water. This check 

must be recorded.

6.7. Handling, Use, Storage and Transport of Equipment

A. Laboratory procedures define the handling and use of the equipment. 

Each piece of equipment has step-by-step instructions for its start-up, 

operation and shutdown described in manufacturer’s manuals or per 

laboratory procedure. Equipment is operated by authorized personnel 

identified by their respective laboratory.

B. The location of equipment in active use is specified in the laboratory 

equipment inventory. Equipment not in use is tagged per instructions in 

Section 6. Procedures, Part 6.5, Out of Service Equipment. 

C. Surplus equipment instructions are found in the Staff Manual Guide 

2620.2; surplus equipment is recorded on FDA Form HHS-22, Request 

for Property Action. 

D. Transport or move sensitive equipment according to manufacturer’s 

instructions. Transportation or moving equipment may be performed by 

the manufacturer or other service provider. Equipment is not returned to 

service until performance checks and verification have been performed 

and recorded.

E. ORS laboratories are secure. Only authorized personnel are permitted 

in the laboratory; non-authorized personnel are escorted. Computer 

software is write-protected and, in most cases, password protected to 

prevent unauthorized program adjustments. These measures safeguard 

the equipment, sample security and computer software.
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7. Glossary/Definitions 

A. Calibration – Calibration is the set of operations, under specified 

conditions, establishing the relationship between values of quantities by 

a measuring instrument or measuring system, or values represented by 

a material measure or reference material, and the corresponding values 

realized by standards.

B. Certified reference material (CRM) – A CRM is a reference material, 

whose property values are certified by a technically valid procedure, 

accompanied by or traceable to a certificate or documentation issued by 

a certifying body.

C. General service equipment – General service equipment is laboratory 

equipment that is not used for measuring but that can affect the results 

of an analysis. Examples include grinders, blenders, ovens, furnaces, 

hotplates, stirrers, non-volumetric glassware used for approximate 

volume measurements (e.g. measuring cylinders), laboratory heating, 

and ventilation systems.

D. Installation qualification (IQ) – This is the identification of all system 

elements, electrical or otherwise. This identification and the subsequent 

documentation for each installed item details normal operating 

instructions, routine user maintenance, preventive maintenance and 

cleaning procedures.

E. Measuring instruments – This includes balances, chromatographs, 

spectrometers, thermometers, timers, viscometers, electrochemical 

meters.

F. Operational qualification (OQ) - OQ is generally described as 

commissioning. It includes calibration and critical instrument test 

parameters defined for the use and purpose of the instrument, and may 

include the definition of upper and lower tolerances.

G. Performance qualification (PQ) - PQ relates to the daily use of the 

instrument and is designed to measure routine performance. Details of 

work instructions and specifications are included.

H. Physical standards – Physical standards includes reference weights 

and reference thermometers.

I. Reference Standard – A reference standard usually has the highest 

metrological quality found at a given location in a given organization, 

from which measurements made there are derived. Generally, this 

refers to recognized national or international traceable standards such 
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as National Institute of Standards and Technology (NIST) thermometers 

and weights.

J. Traceability – Traceability is the property of the result of a measurement 

or the value of a standard whereby it can be related to stated 

references, usually national or international standards, through an 

unbroken chain of comparisons all having stated uncertainties (VIM: 

1999-6.10).

K. Verification Confirmation - Verification confirmation is through the 

provision of objective evidence that specified requirements have been 

fulfilled. (ISO 9000: 2000 3.8.4) 

NOTE: In connection with the management of measuring equipment, 

verification provides a means for checking that the deviations between 

values indicated by a measuring instrument and corresponding known 

values of a measured quantity are consistently smaller than the 

maximum allowable error defined in a standard, regulation or 

specification peculiar to the management of the measuring equipment.

The result of verification leads to a decision to restore in service, 

perform adjustments or repair, downgrade or declare the equipment 

obsolete. In all cases, written traceability of the verification performed is 

kept on the measuring instrument's individual record. 

8. Records 

A. Equipment maintenance and performance checks records

B. Calibration records

C. Installation and operation qualification records obtained from equipment 

manufacturer or installer

D. Equipment inventory

E. Equipment software master list

9. Supporting Documents 

None
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10. Document History

Revision

#

Status*

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

1.2 R 6/22/05 LMEB LMEB

1.3 R 11/16/05 LMEB LMEB

1.4 R 11/15/07 LMEB LMEB

1.5 R 10/30/08 LMEB LMEB

1.6 R 06/07/10 LMEB LMEB

1.7 R 09/23/13 LMEB LMEB

1.8 R 05/08/14 LMEB LMEB

02 R 06/06/2019 LMEB LMEB

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

11. Change History

Revision 

# Change

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

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

12. Attachments

List of Attachments

Attachment A - Equipment Requirements...................................................................11
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Attachment A - Equipment Requirements

Equipment/System Parameter Frequency

Autoclaves Accuracy of temperature sensing 

system

Calibrate at installation (or initial use)

Verify annually

Maximum temperature achieved Verify each day

Performance Verify weekly with biological sterility 

indicator

Uniformity 1 Conduct an initial mapping of chamber at 

installation & annually thereafter

Stability of temperature At installation and annually as needed2

Automated colony 

chambers

Accuracy Verify annually with manual count

Balances Mass measurement Verify daily when in use with internal 

calibration or with a working weight

Calibrate3 Annually

When moved to a different location or 

after repair

Chromatographic 

systems (GC, IC, LC)

See additional requirements below for 

dietary supplements

Detector response Verify for the analytical methods at least 

once with each batch.4

Dispensing equipment & 

vial fillers used in 

Microbiology

Mass measurement/volume Verify at installation & daily when in use 

at each volume dispensed

Freeze dryers, vacuum 

ovens

Ability to achieve & sustain 

vacuum; vacuum gauges verified 

Verify at installation and annually 

thereafter
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Equipment/System Parameter Frequency

against calibrated gauge

Hydrometer, reference Specific gravity Calibrate every 2 years

Hydrometer, working One-point comparison to reference 

hydrometer

Verify Annually

Microscopes used for 

measuring

Length Calibrate stage micrometer at installation 

or initial use

pH meters ion selective, 

& related conductivity 

equipment5

Calibrate against reference buffer5

or reference solution at level of use 

or bracketing range of use

Each day of use

Temperature controlled 

chambers used for 

storage (e.g. 

refrigerators and 

freezers)

Verify temperature Frequency is dependent upon mechanism 

of monitoring6

Uniformity of temperature by 

mapping the chamber

At installation (or initial use) and after 

nonroutine maintenance7

Temperature controlled 

chambers used for 

testing (e.g. ovens, 

furnaces, incubators, 

water baths)

Verify temperature Check daily am and pm when in use with 

at least 4 hours between verifications

Uniformity of temperature1 by 

mapping the chamber

At installation (or initial use) and after 

nonroutine maintenance7

Temperature sensing 

devices/systems, 

reference (thermometers, 

thermocouples, data 

loggers, data tracers, 

thermistors, digital 

displays, continuous 

monitors, etc.)

Calibrate temperature to the 

appropriate traceable standard

Every 2 years

Temperature sensing 

devices/systems, 

working (thermometers, 

Verify temperature against 

reference device

Annually
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Equipment/System Parameter Frequency

thermocouples, data 

loggers, data tracers, 

thermistors, digital 

displays, continuous 

monitors, etc.)

Timers & internal timing 

devices8

Time

Verify working device annually against 

reference or against NIST time clock9

UV/Vis 

spectrophotometer

Blank reading Verify daily when in use 

Wavelength Verify at installation & annually

Volumetric delivery 

devices: mechanical 

pipets, micropipettes, 

mechanical burets, & 

liquid dispensers

Accuracy & precision using mass of 

water at a known temperature or by 

spectrophotometric method

Verify upon receipt (manufacturer’s 

Certificate of Accuracy may be accepted) 

Minimum every 6 months

Volumetric delivery 

devices: positive 

displacement syringes 

used for volumetric 

delivery

Accuracy Verify upon receipt: (manufacturer's 

Certificate of Accuracy may be accepted)

Volumetric glassware, 

non-class A (pipets, 

burets, & volumetric 

flasks)

Accuracy using mass of water at a 

known temperature or by 

spectrophotometric method

Verify upon receipt

Water activity meter Water activity of known solutions Verify daily when in use5

Water, used in all 

analyses to meet method 

requirements

Method specific water quality 

attributes

Minimally every month

Water, used for 

microbiological analyses

Acceptable levels of chlorine and 

aerobic plate count

Monthly
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Equipment/System Parameter Frequency

Water used for 

pharmaceutical analyses

The eight types of water are as 

follows:

1. Nonpotable

2. Potable (drinkable) water

3. USP purified water

4. USP water for injection

5. USP sterile water for injection

6. LUSP sterile water for 

inhalation

7. USP bacteriostatic water for 

injection

8. USP sterile water for irrigation

Meet FDA Inspection Technical Guide 

Requirements:

https://www.fda.gov/ICECI/Inspections/In

spectionGuides/InspectionTechnicalGuide

s/ucm072925.htm

Weights, reference Mass Calibrate every 5 years3

Weights,working Mass Verify against reference weight annually

NOTES:

1. Uniformity may not be needed for low-capacity equipment such as small chambered autoclaves, 

incubators, ovens, & refrigerators; circulating water baths; muffle furnaces; & freezers based on use 

or design. In these cases, the laboratory should have reasonable justification and document the 

justification for not determining uniformity and suitability.

2. Autoclaves equipped with a calibrated temperature sensing device that provides a record of 

temperature are considered to meet this requirement.

3. All weights & balances shall be calibrated traceable to recognized national or international units 

(NIST, BIPM, OIML, or equivalent traceable weights). They must be calibrated by an ISO/IEC 

17025accredited calibration laboratory.

4. For quantitative methods, an analytical standard at the mid-range or lower of the calibration curve 

can verify detector response. For qualitative assessments, the appropriate response material must be 

used.

5. When pH or water activity results are reported to the customer or may be a significant component of 

overall uncertainty of the measurand, the reference material (e.g. buffer or water activity analytical 

standard) must satisfy the requirements for metrological traceability. Buffers used for this purpose 

must be obtained from an ISO 17034-accredited manufacturer.

6. The intent is the laboratory must be able to verify that samples were stored at the proper temperature 

for the duration of storage. Continuous monitoring with a calibrated and validated system meets this 
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requirement. A min/max data logging thermometer would require verification at a frequency 

dependent upon the amount of data it can store.

7. When determining mapping schedules, attention should be paid to extremes in laboratory ambient 

conditions (such as those brought on by seasonal changes) that can influence the performance of the 

equipment. Initial and nonroutine maintenance monitoring can be done with no load.

8. Timers and internal timing devices only need to be verified when time is a critical factor in the test 

method. Time may not be a critical factor when time is not the reported result or a precise time is 

not required for the test method. 

9. Accrediting bodies may require Initial calibration by an ISO 17025 accredited calibration laboratory.