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Document Number:

MAN-000025

Revision #: 05

Revised:

14 Jun 2022

Title: 

ORA Lab Manual Vol. I - Manual of Quality Policies for ORA Regulatory 

Laboratories (ORA-LAB.QM)

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Sections in This Document

1. Introduction.............................................................................................................................2

2. Controlled Distribution of the Quality Manual .....................................................................2

3. Quality Policy Statement........................................................................................................2

3.1. Management System Objectives ................................................................................3

3.2. Management System Awareness and Implementation ............................................3

4. General Requirements ...........................................................................................................3

4.1. Impartiality....................................................................................................................3

4.2. Confidentiality ..............................................................................................................4

5. Structural Requirements........................................................................................................5

5.1. Laboratory as Legal Entity..........................................................................................5

5.2. Management Responsible for Laboratory .................................................................5

5.3. Scope of Accredited Laboratory Activities................................................................6

5.4. Laboratory Requirements ...........................................................................................6

5.5. Laboratory Organizational Structure and Procedures .............................................6

5.6. Personnel Responsibilities and Authority.................................................................7

5.7. Communication and Integrity of the Management System......................................9

6. Resource Requirements ........................................................................................................9

6.1. General..........................................................................................................................9

6.2. Personnel....................................................................................................................10

6.3. Facilities and Environmental Conditions.................................................................12

6.4. Equipment...................................................................................................................14

6.5. Metrological Traceability...........................................................................................18

6.6. Externally Provided Products and Services............................................................19

7. Process Requirements.........................................................................................................21

7.1. Review of Requests, Tenders, and Contracts .........................................................21

7.2. Selection, Verification and Validation of Methods..................................................24

7.3. Sampling.....................................................................................................................27

7.4. Handling of Test or Calibration Items ......................................................................28

7.5. Technical Records .....................................................................................................28

7.6. Evaluation of Measurement Uncertainty..................................................................29

7.7. Ensuring the Validity of Results ...............................................................................30
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Document Number:

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Revision #: 05

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Title: 

ORA Lab Manual Vol. I - Manual of Quality Policies for ORA Regulatory 

Laboratories (ORA-LAB.QM)

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7.8. Reporting Results ......................................................................................................31

7.9. Complaints..................................................................................................................34

7.10. Nonconforming Work ................................................................................................35

7.11. Control of Data and Information Management........................................................36

8. Management System Requirements...................................................................................37

8.1. Options........................................................................................................................37

8.2. Management System Documentation (Option A)....................................................37

8.3. Control of Management System Documents (Option A)........................................40

8.4. Control of Records.....................................................................................................41

8.5. Actions to Address Risks and Opportunities..........................................................41

8.6. Improvement...............................................................................................................42

8.7. Corrective Actions .....................................................................................................42

8.8. Internal Audits............................................................................................................43

8.9. Management Reviews................................................................................................44

Document History ...................................................................................................................45

Change History.......................................................................................................................45

Attachments............................................................................................................................46

1. Introduction

This Office of Regulatory Affairs (ORA) Laboratory Manual of Quality Policies (hereafter 

referred to as Volume I) has been prepared to meet the requirements for laboratory 

accreditation of the International Organization for Standardization/International 

Electrotechnical Commission (ISO/IEC 17025:2017).

2. Controlled Distribution of the Quality Manual

The Office of Regulatory Science (ORS) is responsible for maintaining the official master 

copy of the ORA Laboratory Manual which contains the ORA Laboratory Quality Manual. 

This Manual consists of Volume I, ORA Laboratory Manual of Management 

Requirements and Volume II, ISO 17025:2017 ORS Laboratory Procedures. The ORA 

Laboratory Manual also includes operational procedures and training in Vol III and Vol IV 

respectively. General distribution of this manual is accomplished using a computer 

network. Biennial review is coordinated by the Office of Regulatory Science.

3. Quality Policy Statement

ORA’s mission statement states “ORA protects consumers and enhances public health 

by maximizing compliance of FDA regulated products and minimizing risk associated 
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Document Number:

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Title: 

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Laboratories (ORA-LAB.QM)

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with those products”. ORS laboratories are committed to providing testing that meets 

both the needs of the customers and the requirements of ISO/IEC 17025:2017 and to 

continually improve the effectiveness of the management system. Testing results are 

reported within stated limits of accuracy, precision, and detection limits as described in 

the methods used for analysis. 

3.1. Management System Objectives

3.1.1. The primary objective of the management system established by ORS 

laboratories is to assure the accuracy and precision of laboratory results so

that they will be reliable, interpretable, repeatable, and defensible. Data 

quality objectives are described in the terms of:

A. accuracy,

B. precision,

C. detection and quantitation limits, 

D. timeliness, and

E. comparability.

3.1.2. The second objective is to establish and maintain national and international 

recognition through compatibility with the requirements of relevant 

standards.

3.1.3. Third, strive to meet or exceed the customer’s needs and expectations.

3.1.4. Fourth, maintain ORS laboratories’ reputation for quality by fostering 

continuous process improvement and problem prevention.

These objectives are considered as part of the reviews performed by 

management.

3.2. Management System Awareness and Implementation

The management system documents, and test methods are included as training 

elements in the laboratory’s training program addressed in the laboratory training 

procedure. This ensures that staff is familiar with quality documentation and 

implement the quality policies and procedures in their work. See ORA Laboratory

Manual, Volume II, ORA-LAB.5.2 Personnel Training and Competency 

Management.

4. General Requirements

4.1. Impartiality

4.1.1. To avoid conflicts of interest, pressures, and influences, FDA employees 
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are familiar with and observe the Standards of Ethical Conduct. These

principles of ethics can be found at the FDA Division of Ethics and Integrity

intranet site.

4.1.2. Laboratory management is committed to sustaining impartiality of all 

personnel by enforcing existing FDA policies and requirements on ethics 

that were implemented to ensure impartiality in the agency’s work. 

The FDA provides several means to ensure impartiality of its employees, 

such as the HHS 520 Request for Approval of Outside Activity and OGE 

450 Confidential Financial Disclosure Report Filer forms which are filled out 

annually and reviewed by the FDA Division of Ethics and Integrity to 

identify potential risks in relationships, ownership, finances, contracts, etc. 

that may impact personnel’s neutrality regarding FDA related activities. In 

addition, a monthly list of significantly regulated organizations is distributed 

for review in keeping with 18 USC § 208 prohibiting personal and 

substantial participation in matters that have direct and predictable effect 

on their financial interests.

The Office of Government Ethics (OGE) also requires one hour of ethics 

training annually. Training is provided on ethics rules, regulations, and 

integrity to help employees avoid placing themselves in a conflict-of-interest 

situation. An employee who performs laboratory testing performs and 

documents a demonstration of competence as prescribed in Volume I, 

Subsection 6.2.

4.1.3. Risks to impartiality are continuously reviewed and eliminated or minimized 

to ensure there is no compromise to the objectivity of staff engaged in 

laboratory activities. Employees are familiar with and observe the 

Standards of Ethical Conduct. Executive Order 12674, issued in 1989 and 

modified in 1990 by Executive Order 12731, states fourteen general 

principles that broadly define the obligations of public service. Two core 

concepts are embodied in these principles: (a) Employees shall not use 

public office for private gain, (b) and employees shall act impartially and not 

give preferential treatment to any private organization or individual.

4.1.4. Risks to impartiality may be identified during required routine disclosures by 

employees, management reviews, or during audits. When laboratory

employees or processes pose a risk to impartiality, an assessment is made 

of the nature of the risk and appropriate corrective actions are taken by the 

laboratory and/or the designated agency authority.

4.2. Confidentiality
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4.2.1. All FDA staff certify their agreement to abide with 5 USC § 552a(1) the 

Privacy Act and 21 USC § 331 The Trade Secret Act when completing 

Computer Security Awareness training. Contract employees are required 

to sign FDA FORM 3398 Commitment to Protect Non-Public Information 

Employee Agreement upon entry to duty. This form certifies their 

agreement to abide with 21 U.S.C. 331(j), 21 U.S.C 360j(c), and 18 U.S.C 

1905. Confidentiality requirements are included in purchasing agreements, 

as needed, with vendors performing work in areas where laboratory work is 

performed.

4.2.2. ORS laboratories do not release confidential information to external parties. 

ORA’s Office of Strategic Planning and Operational Planning, Division of 

Information Management Disclosure Policy manages ORA’s information 

disclosure functions.

4.2.3. Reports of information and data are transmitted and filed in accordance 

with official policies, directives, and notices of the department and the 

agency. Most reports are only transmitted internally within the agency, 

except as required by law or regulation. Information is released only to the 

customer or designated representative. Field Management Directive (FMD) 

No. 147, Procedure for Release of Analytical Results Pursuant to Section 

704 (d), provides guidance for reporting analytical results to an external 

customer.

4.2.4. FDA facilities are controlled-access buildings to further ensure protection of 

data. Names and purpose of all non-FDA visitors are provided to security 

prior to planned visits. Additional department policies are in place for 

visitors from other countries. Visitors are continuously escorted by FDA 

representatives and allowed only in areas approved by mandated security 

protocols in place to ensure no customer or federal information is 

compromised. Additionally, employees sign commitments to properly keep 

and use confidential information obtained or witnessed during their duties.

5. Structural Requirements

5.1. Laboratory as Legal Entity

The Food and Drug Administration (FDA) is a government agency under the 

Department of Health and Human Services (DHHS). The agency is required to 

follow the federal regulations in 21 CFR, 29 CFR, 40 CFR, 49 CFR, the FD&C Act 

and PHS Act.) ORS laboratories are legally responsible for all activities within their 

operations.

5.2. Management Responsible for Laboratory
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The Office of Regulatory Affairs Associate Commissioner is responsible for 

establishing the organization’s commitment to the management system, 

implementing it, and delegating responsibility for its accomplishment.

The Director of the Office of Regulatory Science is responsible for issuing policy 

and procedures for the ORS laboratories and monitoring their implementation.

Laboratory management, analysts, and quality managers are responsible for 

ensuring that analytical activities meet the requirements of the agency, its 

customers, and regulations in 21 Code of Federal Regulations (CFR), 29 CFR, 

Part 1910.1450, 40 CFR, Parts 260-264, 49 CFR, Parts 171-173 and the Food, 

Drug and Cosmetic (FD&C) Act. In addition, each person involved in the 

generation of data is part of the management system.

5.3. Scope of Accredited Laboratory Activities

Laboratory activities encompass all processes from the review of vendors for 

external products and services to sample, equipment, supply, and data handling 

and reporting within the laboratory. All ORS laboratories have documented 

training, proficiency, and method validation and verification programs in place. To 

ensure consistency in these processes controlled, approved documents are 

maintained to provide guidance in all processes and records retained to recreate 

processes, if needed. These also provide the basis to evaluate risks and 

improvements where gaps are identified through nonconformances, complaints, 

and annual management review of the inputs and outputs of operations. 

5.4. Laboratory Requirements

5.4.1. The intent of ORA is to operate testing laboratories per the following 

requirements:

A. FDA policies and procedures,

B. ISO/IEC 17025:2017,

C. Customer contracts (workplan),

D. ORA compliance programs and assignments,

E. Federal and State laws and regulations, and

F. Accreditation registrar requirements.

5.4.2. ORS laboratories operate permanent facilities across the United States and 

Puerto Rico at the locations identified in the Staff Manual Guides (SMG), 

1121.92 Office of Medical Products and Specialty Laboratory Operations 

and 1121.93 Office of Food and Feed Laboratory Operations.

5.5. Laboratory Organizational Structure and Procedures
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5.5.1. The regulatory laboratories are a part of the Office of Regulatory Affairs, 

FDA and are identified in SMG 1121.9 series. The organization and the 

relationship among the laboratory staff is reflected in the laboratory’s 

organizational chart maintained by the laboratory. These charts provide 

relationships between management, technical operations, and support 

personnel.

5.5.2. The laboratory has managerial staff with the authority to discharge their 

duties as reflected in the prepared job descriptions by the laboratory. This 

authority includes the implementation, maintenance, and improvement of 

the management system. Management authorities are defined in 

government classification standards found on the U.S. Office of Personnel 

Management website.

Job responsibilities for laboratory employees are documented in the 

management system procedures and operating instructions. Position 

descriptions are maintained by the Office of Talent Solutions (OTS).

5.5.3. The laboratory management system is outlined in the following documents:

A. Quality manual,

B. Written procedures,

C. Work Instructions,

D. References, and

E. Forms and records.

This management system is established to address the requirements in ISO/IEC 

17025:2017. Each entity establishes and maintains documents per the procedure 

for document control. The quality policy and quality objectives for ORS laboratories 

are included in Volume 1, section 3. The documents listed above are accessible to 

all personnel and are included in the laboratory’s training program.

5.6. Personnel Responsibilities and Authority

Laboratory personnel are aware of their roles and contributions in the management 

system and of its objectives through regularly scheduled training provided by the 

quality staff. Laboratory personnel irrespective of other responsibilities have the 

authority and resources to carry out their duties.

5.6.1. General roles and responsibilities for ORS laboratory personnel are 

summarized as follows:

A. Quality System Manager 
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1. Ensures that the management system is established, implemented, 

and maintained in conformance with the requirements of ISO/IEC 

17025:2017.

2. Advocates and coordinates quality improvements to the 

management system.

B. Responsible Managers (technical management)

1. Oversee technical functions.

2. Ensure compliance with the requirements of ISO/IEC 17025:2017.

3. Ensure management system procedures, applicable standards, 

specifications, and regulations are followed.

4. Ensure that qualified, skilled, and trained personnel and other 

resources are available.

5. Ensure that products and services satisfy customer requirements.

C. Analysts and support staff

1. Ensure the quality of their work.

2. Operate in conformance with the requirements of the management 

system.

5.6.2. All laboratory employees have the authority and are encouraged to identify 

and report deviations from the management system or procedures for 

laboratory activities.

5.6.3. All laboratory employees contribute toward initiation of actions to minimize 

such deviations or provide input toward improvement to the system. These 

actions are monitored and reviewed by laboratory management. 

5.6.4. The laboratory Quality System Manager (QSM) is responsible for 

monitoring the laboratory’s management system and reporting its 

performance and any need for improvement to laboratory management.
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5.6.5. Laboratory Management is responsible for the technical operations of the 

laboratory. Resources for training, laboratory methods, measurement 

traceability, and purchasing are described in other sections of this Volume 

and in relevant FDA procedures and policies.

5.6.6. Qualified laboratory personnel are assigned to serve in the absence of key 

managerial personnel, such as Laboratory Director, Quality System 

Manager, and Supervisors to maintain unbroken continuation of operations. 

In addition the laboratory has an active and executable contingency plan 

for the Continuity of Operations (COOP) in place with effectiveness drills 

enacted at least once each year.

5.7. Communication and Integrity of the Management System

5.7.1. Effective communication from management occurs through, but is not 

limited to, memos, newsletters, electronic presentations, emails, or verbally 

to laboratory personnel regarding the effectiveness of the management 

system and the importance of meeting customer, statutory, and regulatory 

requirements

5.7.2. The management system process and procedures as defined in this 

manual maintain the integrity of the management system when changes 

such as a change in the structure of the organization or management, or a 

change is a policy or procedure are made.

6. Resource Requirements

6.1. General

Personnel, facilities, equipment, systems, and support services necessary for the

management and performance of laboratory activities are evaluated and put in 

place to ensure defensible data and conformity to the requirements of ISO/IEC 

17025:2017 General requirements for the competence of testing and calibration 

laboratories.

6.1.1. The sections following below address the factors affecting the correctness 

and reliability of the tests performed by a laboratory. These factors include 

contributions from:

A. Personnel (MAN-000035 ORA Laboratory Manual, Volume II, ORALAB.5.2 Personnel Training and Competency Management),

B. Facilities and environmental conditions (MAN-000036 ORA Laboratory 

Manual, Volume II, ORA-LAB.5.3 Facilities and Environmental 

Conditions),
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C. Equipment (MAN-000039 ORA Laboratory Manual, Volume II, ORALAB.5.5 Equipment),

D. Metrological traceability (MAN-000037 ORA Laboratory Manual, 

Volume II, ORA-LAB.5.4.5 Methods, Method Verification and Validation; 

MAN-000041 ORA-LAB.5.6 Measurement Traceability), and

E. Externally provided products and services (MAN-000027 ORA 

Laboratory Manual, Volume II, ORA-LAB.4.6 Purchasing and Receipt)

6.1.2. The procedures listed in each section address these factors.

6.2. Personnel

6.2.1. Personnel

All laboratory personnel that could influence laboratory activities act impartially, 

are competent, and perform their work according to the laboratory’s 

management system. These positions include, but are not limited to analysts, 

supervisors and managers, laboratory support staff, sample custodians, and 

administrative management staff.

6.2.2. Competence Requirements

A. Competence is based on education, experience, demonstrated skills, 

and training. Staff records contain the documentation of personnel 

education, qualification, experience, technical knowledge, skills, and 

training for the position held. 

B. Skills of personnel are based upon demonstration of competence. 

Competency requirements for each function influencing the results of 

laboratory activities are documented in the laboratory’s training 

documents. This demonstration is to be completed successfully before 

laboratory personnel generate data independently. The effectiveness of 

personnel training is documented in, but not limited to management 

reviews, internal audits, external assessments, proficiency testing, and 

performance evaluations.

6.2.3. Personnel Competence

A. Laboratory management ensures that laboratory personnel have the 

competence to perform their duties and to evaluate the significance of 

deviations. 

B. Trainees undergo a training program in accordance with the laboratory’s 

training documents and ORA Office of Training, Education and 

Development (OTED) standards. Trainees perform procedures when 

training and competency has been demonstrated. The documented 
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demonstration of competence is an exercise that the trainee performs 

independent of supervision. The trainee is considered competent after 

the specified criteria have been successfully met.

6.2.4. Communication of Duties, Responsibilities and Authorities

A. Job duties, responsibilities and authorities for laboratory employees are 

documented in the management system procedures and operating 

instructions. 

B. Position descriptions are maintained by the Office of Talent Solutions

(OTS). The laboratory maintains active job descriptions for managerial, 

technical, and key support personnel involved in laboratory activities. 

Job descriptions are established based on current duties and 

technologies utilized.

C. The laboratory employees involved in laboratory activities have access 

to consensus standards, instrument manufacturers’ manuals, and 

laboratory procedures for reference. 

D. Effective communication from management occurs through, but not 

limited to, memos, newsletters, electronic presentations, emails, or 

verbally to laboratory personnel regarding the effectiveness of the 

management system.

6.2.5. Personnel Procedures

A. The procedure for determining competence requirements are defined in 

the laboratory’s documents and MAN-000035 ORA-LAB.5.2 Personnel 

Training and Competency Management.

B. The Food and Drug Administration’s, Office of Talent Solutions (OTS)

establishes the hiring procedures for the agency. 

C. The individual and management are jointly responsible for the setting, 

the pursuit, and achievement of educational goals for professional 

advancement. The annual performance evaluation process can be 

used by the individual to discuss career advancement and training 

possibilities. By using this process, individuals can identify areas of 

study and request training oriented towards the attainment of their 

goals. Procedures for employee career development are described in 

SMG 3120.1, Staff Development and Training.

D. Training needs are identified in accordance with the analyst’s discipline 

(e.g., Chemist, Microbiologist) and FDA ORA/OTED standards. Inhouse training is conducted per laboratory’s training procedure. Present 

and anticipated tasks of the laboratory are addressed in the planning of 

special training modules.
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E. The management system documents, and test methods are included as 

training elements in the laboratory’s training program addressed in the 

laboratory training procedure. This ensures that staff is familiar with 

quality documentation and implement the quality policies and 

procedures in their work. 

F. The laboratory utilizes the skills and talent of both full-time employees 

and contract personnel. The requirements of the management system 

are administered equally to both categories. No differentiation is made 

between the two categories of workers. Supervision, training, and 

competence are documented for all technical and key support 

personnel.

Supervisors are designated, and trainees do not perform regulatory 

work until competent as per the laboratory training program. 

G. Personnel are authorized to perform specific laboratory activities 

according to section 6.2.6 and local documents. 

H. Personnel competency is monitored through onsite reviews, reporting 

and worksheet write-ups, demonstration through documentation of the 

required instrument maintenance and function checks, results obtained 

on proficiency test samples, number of samples analyzed satisfactorily 

and QC samples within established criteria.

6.2.6. Personnel Authorization

A. The Laboratory Management authorizes personnel to perform specific 

laboratory activities, including but not limited to:

1. Development, modification, verification, and validation of methods.

2. Analysis of results, including statements of conformity or opinions 

and interpretations. 

3. Report, review, and authorization of results.

B. Records of authorizations, demonstration of competence, education, 

training, and experience are maintained by the laboratory and dated. 

Training files are maintained and include these records.

Related Procedures/References

• MAN-000035 ORA Laboratory Manual, Volume II, ORA-LAB.5.2 Personnel 

Training and Competency Management

6.3. Facilities and Environmental Conditions
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6.3.1. Suitability of Facilities and Environmental Conditions

The laboratory environmental conditions facilitate the correct performance 

of analytical testing. Examples of environmental influences are energy 

sources, lighting, biological sterility, dust, humidity, and temperature. The 

laboratory monitors critical environmental conditions to ensure that results 

and the quality of the measurement are not adversely affected or 

invalidated.

6.3.2. Documentation of Requirements for Facilities and Environmental 

Conditions

Test methods and environmental monitoring procedures used by the 

laboratory include instructions addressing applicable environmental 

conditions.

6.3.3. Monitoring, Controlling and Recording Environmental Conditions

A. Environmental conditions requiring monitoring include, but are not 

limited to:

1. room temperature and humidity,

2. air flow rates for chemical fume hoods, 

3. biosafety hoods and laminar flow hoods,

4. metal contamination on benches and hoods in laboratories 

performing metal analysis,

5. microbiological contamination on bench surfaces and hoods in 

microbiology

6. laboratories, and 

7. air sampling for microbiological contamination in microbiology areas.

B. Where environmental controls are needed, the environmental conditions 

are recorded.

C. Testing activities are stopped when the environmental conditions 

invalidate the test results or adversely affect quality control. Monitoring 

activities are conducted as part of the laboratory test or calibration 

methods.

6.3.4. Measures to Control Facilities

The following measures to control facilities are implemented, monitored 

and periodically reviewed:

A. Access and use of areas affecting laboratory activities
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ORS laboratories are limited access areas. Access and use is 

controlled by, but is not limited to:

1. issuance of keycards for entrance,

2. escorting visitors,

3. issuance of identification badges, and

4. the use of security guards.

B. Housekeeping

Laboratory areas are maintained clean and orderly to prevent 

contamination of samples and to facilitate the efficiency of laboratory 

operations. MAN-000036 Volume II, Section 2, ORA-LAB.5.3 Facilities 

and Environmental Conditions specifies minimum housekeeping 

measures. The laboratory’s Chemical Hygiene Plan and Hazardous 

Waste Management Plan include measures taken to ensure good

housekeeping in the laboratory. 

C. Cross-contamination

Separate areas are maintained for incompatible activities. Measures 

taken to prevent cross-contamination include, but are not limited to:

1. chemistry laboratories are separated from microbiology laboratories,

2. sample receiving, and storage are conducted in designated areas,

3. separate storage for standards and reference materials and cultures, 

and

4. microbiology media preparation and sterilization are separated from 

work areas. 

Related Procedures/References

• MAN-000036 ORA Laboratory Manual, Volume II, ORA.LAB.5.3, Facilities 

and Environmental Conditions.

• Laboratory Chemical Hygiene Plan.

• Laboratory Waste Management Plan.

6.3.5. Work Performed Outside the Laboratory’s Permanent Control

In the event staff perform laboratory activities at sites outside of the 

laboratory’s control, facility and environmental requirements are met. 

6.4. Equipment
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6.4.1. Access to Laboratory Equipment

A. The laboratory has sample preparation, measurement, and test 

equipment for the correct performance of the tests and calibrations. The 

laboratory also has ancillary equipment for processing samples and for 

processing data. Also see section 6.5 Metrological Traceability.

B. The laboratory or other ORA component, i.e., Office of Regulatory 

Science, purchases the equipment used by the laboratory. Maintenance 

contracts are established as needed. In those cases where the 

laboratory leases equipment it has direct control concerning its use. 

Leased equipment is managed in the same manner as purchased 

equipment according to the management system requirements.

C. ORS laboratories maintain an equipment inventory of all laboratory 

equipment used to perform regulatory testing. 

6.4.2. Equipment Outside the Laboratory’s Permanent Control

If for any reason equipment leaves the direct control of the laboratory the 

laboratory ensures the equipment requirements are met before using the 

equipment.

6.4.3. Procedure for Handling, Transport, Storage, Use and Planned 

Maintenance of Equipment

The laboratory has procedures in MAN-000039 Volume II, Section 2, ORALAB.5.5 Equipment and MAN-000041 ORA-LAB.5.6 Measurement 

Traceability for the safe handling, transport, storage, use and planned 

maintenance of equipment to ensure proper functioning and to prevent 

contamination or deterioration.

6.4.4. Verification of Equipment Prior to Being Placed or Returned into 

Service

A. The equipment performance is verified, and verification records are 

maintained. Equipment is to meet the laboratory's testing parameters 

and conform to standard specifications before being placed or returned 

into service.

B. Procedures for equipment verification are provided in MAN-000039

Volume II, Section 2, ORA-LAB.5.5 Equipment.

6.4.5. Equipment Accuracy/Uncertainty

Equipment and its software used for testing are to achieve the accuracy 

expected, measurement uncertainty required, and comply with specifications 

of the testing concerned. 
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The uncertainty contributions are addressed in MAN-000038 ORA Laboratory 

Manual, Volume II, Section 2, ORA-LAB.5.4.6. Estimation of Uncertainty of 

Measurement.

6.4.6. Equipment Calibration

Measuring equipment is calibrated when the measurement accuracy or 

uncertainty affect the reported results and/or calibration of the equipment is 

required to establish metrological traceability of the reported result.

Procedures for equipment calibration are provided in MAN-000039 Volume II, 

Section 2, ORA-LAB.5.5 Equipment and MAN-000041 ORA-LAB.5.6 

Measurement Traceability.

6.4.7. Calibration Program

The equipment calibration program is defined in MAN-000039 Volume II, 

Section 2, ORA-LAB.5.5 Equipment and MAN-000041 ORA-LAB.5.6 

Measurement Traceability. These procedures are reviewed and revised 

according to MAN-000026 ORA-LAB.4.3 Document Control and Management.

6.4.8. Calibration Status

Equipment under the control of the laboratory and requiring calibration, or 

having a defined period of validity, is labeled or coded to indicate the 

calibration status or period of validity. Alternatively, equipment calibration 

status may be identified in an associated record to indicate the status of 

calibration.

6.4.9. Out of Service

Equipment that has been subjected to overloading or mishandling, gives 

suspect results, or has been shown to be defective or outside specified limits, 

is taken out of service. It is isolated to prevent its use or clearly labeled or 

marked as being “Out of Service” to prevent its use until it has been repaired 

and shown by calibration or test to perform correctly.

Laboratory personnel examine the effect of the defect or departure from 

specified limits on previous tests according to Volume I, Section 7.10 Nonconforming Work.

6.4.10. Calibration Confirmation

Intermediate calibration confirmation checks are performed to maintain 

confidence in the calibration status of the equipment. These checks are 

conducted according to the procedure in Volume I, Section 7.7 Ensuring the 

Quality of Test Results.
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Metrological confirmation for reference standards and reference materials 

included in the calibration program is conducted according to a schedule 

addressed in the procedure in MAN-000039 Volume II, Section 2, ORALAB.5.5 Equipment. The confirmation is conducted to maintain confidence in 

the calibration status of reference standards and reference materials.

6.4.11. Correction Factors

Where calibrations give rise to a set of correction factors, these factors are 

updated and implemented to meet specified requirements.

6.4.12. Safeguards

Test and calibration equipment, including both hardware and software, are 

safeguarded from adjustments that would invalidate the test or calibration 

results. Safeguards are provided using access control to the laboratory.

6.4.13. Equipment Records

Records are maintained of each item of equipment and its software that can 

influence laboratory activities according to the procedure in MAN-000040

Volume II, Section 2, ORA-LAB.5.5.1 Instrument and Equipment 

Documentation and Records. 

The records include at least the following items, where applicable:

A. identity of equipment, including its software and firmware version.

B. manufacturer’s name, type identification, and serial number or other 

unique identification.

C. evidence of verification that equipment conforms with specified 

requirements.

D. current location of the equipment.

E. calibration dates, results and copies of reports and certificates of 

calibrations, adjustments, acceptance criteria, and the due date of next 

calibration or the calibration interval.

F. documentation of references materials, results, acceptance criteria, 

relevant dates and the period of validity.

G. maintenance plan and maintenance carried out to date, where relevant 

to the performance of the equipment; and

H. details of any damage, malfunction, modification, or repair to the 

equipment.
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6.5. Metrological Traceability

6.5.1. Establishing and maintaining metrological traceability

The program for calibration of equipment demands that calibrations and 

measurements made by the laboratory are traceable to the International 

System of Units.

Calibration laboratories providing services to ORS laboratories are to provide 

evidence of measurement traceability of its own measurement standards and 

measuring instrument to the SI. This is done by means of an unbroken chain 

of calibration or comparisons linking them to primary standards of the SI units 

of measurement. Such primary standards are those used by national 

measurement standards.

Calibration certificates issued by calibration laboratories are to include the 

measurement results, including the measurement uncertainty and a statement 

of conformance with an identified metrological specification.

6.5.2. Ensuring measurement results are traceable

A. Calibration laboratories providing services to ORS laboratories are to 

provide documentation demonstrating measurement capability and 

competence to perform the calibration services requested by ORS 

laboratories.

B. A reference material is a homogenous and well characterized 

substance used for standardization of equipment used in the testing 

process. Reference materials are traceable to national or international 

standard reference materials (SRMs), such as National Institute of 

Standards and Technology (NIST), or certified reference materials 

(CRMs) from competent suppliers of reference materials. 

The measurement integrity of internal reference materials generated by 

the laboratory is evaluated against either standard reference materials 

or certified reference materials from an independent source when it is 

technically and economically possible.

C. The measurement traceability to SI units may be achieved by 

measurements related to national measurement standards. National 

measurement standards may be used as primary standards that are 

primary realizations of the SI units or agreed representations of SI units. 

National measurement standards based on fundamental physical 

constants, or standards calibrated by another national metrological 

institute may be use as primary standards.
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6.5.3. Non-traceability of reference standards to SI units

Calibrations that cannot provide strict measurement traceability to SI units are 

conducted such that the calibration results can provide confidence in the 

measurements made in the course of the analyses. Traceability alternatives to 

SI units are described in the procedure in MAN-000041 Volume II, Section 2, 

ORA-LAB.5.6 Measurement Traceability.

6.6. Externally Provided Products and Services

6.6.1. Suitability of Externally Provided Products and Services

The laboratory ensures that only suitable externally provided products and 

services that affect laboratory activities are used when they are intended for 

incorporation into the laboratory’s activities and/or used to support the 

operation of the laboratory.

ORS laboratories do not subcontract routine analyses within their scope of 

accreditation.

Collaborative activities conducted with external laboratories, such as 

universities, are research in nature and do not involve the routine analysis of 

FDA samples.

Subcontracting Laboratories

Based on workload fluctuations and resource needs, ORS laboratories may 

request samples assigned to other FDA laboratories for analysis. Samples are 

administratively transferred after arrangements are made to ensure that the 

receiving laboratory has the capacity and capability to complete it in a timely 

manner. 

Samples are shipped per Department of Transportation (DOT), United States 

Post Office (USPS), and carrier regulations. ORA Laboratory Manual (LM), 

Volume III, Section 2, Chain of Custody describes the procedure for 

documenting administratively transferred samples (ATS).

Notification of Customer

FACTS (Field Accomplishment and Compliance Tracking System), which is 

accessible to the customer, serves as a notice of the transfer.

Laboratory Responsibility

The FDA laboratory to which the sample has been transferred assumes 

responsibility to the collector for the work. 

Related Procedures/References
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• MAN-000046 ORA Laboratory Manual, Volume III, Section 2, Chain of 

Custody – Sample Handling

6.6.2. Purchasing services and supplies

A. MAN-000027 ORA-LAB.4.6 Purchasing and Receipt provides policies 

and instructions for procurement of supplies, materials, equipment, and 

services that affect the quality of tests. It documents the procedures for 

purchase, reception, and storage of supplies, materials, and equipment 

relevant to tests.

B. The laboratory or designated purchasing agents use Federal Acquisition 

Regulations (FAR) and related procedures for the procurement of 

materials, supplies and services that critically affect the quality of the 

tests or calibrations. These procedures describe the process for the 

selection, purchase, reception and storage of equipment, services and 

supplies, including reagents and laboratory consumable materials, used 

in the performance of the tests and calibrations. Each laboratory has 

work instructions describing the processing of requisitions.

C. Purchasing documents for items affecting the quality of laboratory 

output describe the services or supplies ordered. These purchasing 

documents are reviewed and approved for technical content prior to 

submission. 

Records of supplier evaluations are maintained by purchasers of 

laboratories equipment, services, and supplies. 

The laboratory’s purchasing procedure describes how purchased 

equipment, supplies, services, reagents, and consumable materials that 

critically affect the quality of tests or calibrations are inspected or 

verified prior to use. Inspection or verification criteria are used to 

establish conformance with requests made by the customer, included in 

standard specifications, or defined in the methods.

D. Records of unsatisfactory materials and supplies and their disposition 

are maintained. These records establish trends in vendor performance 

and ensure that continuing quality material is accepted. A vendor is 

considered unacceptable and is not used when the quality of product or 

service does not meet expectations or specifications. 

6.6.3. Communicating requirements to external providers

Critical specifications and requirements are clearly described on the 

purchasing requests and are communicated to external providers by the 

Purchasing Agent. These criteria include: 
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A. The products and services to be provided.

B. The acceptance criteria; and 

C. Competence, including any required qualification of personnel

ORS laboratories do not subcontract routine analyses within their scope of 

accreditation.

Related Procedures/References

• Government Accounting Office (GAO) Policy and Procedures Manual

• SMG 2610 Procurement and Supply Management

• Federal Acquisition Requirements 

• Office of Management and Budget (OMB), General Service Administration 

(GSA), HHS, Federal Property Management Regulations (FPMR), FDA 

and ORA manuals, specific issuances

• Public Law (PL) 95-507

7. Process Requirements

7.1. Review of Requests, Tenders, and Contracts

7.1.1. Procedure

ORA, Division of Planning and Evaluation (DPE) develops and issues the 

Annual Fiscal Year (FY) Workplan for ORA field units. The portion of the 

workplan concerned with the ORS laboratories is a cooperative effort among 

the Centers, ORA Field Committee, and ORS. The workplan is based on 

several factors such as the budget, the number of analysts and number of 

resources, the Commissioner’s performance goals, the compliance program 

accomplishment goals, the inventory of regulated industry maintained by the 

field units, and FDA-targeted products. Distribution of assignments is by 

Program Assignment Code (PAC) and full time equivalent (FTE) hours within 

the different program areas. The compliance programs specify or cite the 

methods for analyses. The ORS laboratories and ORS review the annual 

workplan to ensure that each laboratory has the capability and resources to 

provide the requested services. Any differences between the workplan and the 

laboratory capability are resolved in accordance with GUID-000250 A Guide to 

Understanding the Program-based Forecast for Work planning or through 

consultation with ORS management. 

In addition to the workplan, assignments may be issued to ORS laboratories 

by an ORA headquarters unit or a Center. Multiple program assignments and 

high priority requests for work are approved per FDA Field Management 
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Directive 17, ORA Field Assignments-Guidelines for Issuance by 

Headquarters. Such assignments are cleared through the Office of Strategic 

Planning and Operational Policy (OSPOP). Assignments specify or cite the 

methods for analyses.

Requests not covered by compliance programs or assignments are reviewed 

prior to receipt of samples by the laboratory’s management when possible. 

The results of this process are discussed and documented as part of the 

laboratory’s annual management review.

7.1.2. Subcontracting Laboratories

The policies regarding the use of subcontracting laboratories are found in 

Volume I Subsection 6.6 Externally Provided Products and Services. The 

customer requesting collaborative testing by laboratories outside of ORA is 

responsible for the work done by such labs. ORA is not responsible for such 

work under these circumstances.

Based on workload fluctuations and resource needs, ORS laboratories may 

request samples assigned to other FDA laboratories for analysis. Samples are 

administratively transferred after arrangements are made to ensure that the 

receiving laboratory has the capacity and capability to complete it in a timely 

manner. 

FACTS, which is accessible to the customer, serves as a notice of the transfer.

Laboratory methods are selected based on compliance programs. When the 

customer does not specify the method to be used, a standard method is 

preferred for use. If a standard method is not found, the laboratory may use 

either a non-standard method or modify a method for use with the concurrence 

of the customer. The non-standard or modified method is validated according 

to Volume I, subsection 7.2.2 Validation of Methods. 

7.1.3. Method Requested is Inappropriate or Out of Date

The laboratory informs the customer when the method proposed by the 

customer is considered to be the incorrect choice or the incorrect revision for 

the intended purpose. This is done as part of contract review addressed in 

section 7.1.1.

7.1.4. Statements of Conformity

When the customer requests a statement of conformity to a specification or 

standard for the test, the specification or standard and the decision rule are 

clearly defined in the compliance programs or standard. Otherwise, the 

laboratory communicates the decision rule selected to the customer and 
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obtains their agreement. See section 7.8.6 Reporting Statements of 

Conformity.

7.1.5. Differences and Deviations

The ORS laboratories and ORS review the annual workplan to ensure that 

each laboratory has the capability and resources to provide the requested 

services. Any differences between the workplan and the laboratory capability 

are resolved prior to commencing work and in accordance with GUID-000250 

A Guide to Understanding the Program-based Forecast for Work planning, or 

through consultation with ORS management. 

7.1.6. Communicating with the customer

Requests for deviations from work assignments or compliance programs are 

processed by the Office of Regulatory Science (ORS). ORS interacts with the 

customer to determine whether the requested changes are acceptable and do 

not impact the integrity of the laboratory or the validity of the results. Records 

of contract changes are maintained.

7.1.7. Amendments to Contracts

If a contract needs to be amended after work has commenced, the same 

contract review process is repeated, and any amendments are communicated 

to all affected personnel named in the contract.

7.1.8. Customer Service

The laboratory affords the requesting customer cooperation to clarify the 

customer's request within the framework of the contract review process 

described in Volume I, Section 7.1.1. The laboratory maintains 

communications regarding deviations from contract work. Communications 

regarding compliance programs, workplan and assignments are conducted 

through ORS.

The opportunity for the customer to witness laboratory activity is given upon 

request, providing the laboratory can maintain confidentiality to other 

customers during such cases.

7.1.9. Records of Review

ORS laboratories maintain records of workplan reviews, changes, and change 

requests. Records are also maintained of discussions regarding ad hoc 

assignments.

Related Procedures/References
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• GUID-000250 A Guide to Understanding the Program-based Forecast for 

Work planning

• FDA Field Management Directive 17, ORA Field Assignments-Guidelines 

for Issuance by Headquarters

• Annual Workplan

7.2. Selection, Verification and Validation of Methods

7.2.1. Selection and Verification of Methods

Specific requirements for the Verification and Validation of methods process 

for ORS laboratories are outlined in MAN-000037 ORA-LAB.5.4.5 Method 

Validation and Verification.

A. The scope of test technologies and associated method source routinely 

used are identified in the laboratory’s accreditation program 

documentation.

B. The estimation of the uncertainty of measurement is addressed in 

Volume I, subsection 7.6. Volume I, Section 7.7 Ensuring the Validity of 

Results of this manual describes the quality control processes, including 

the application of statistical techniques, for supporting test and 

calibration data.

C. Laboratory methods and supporting documents are controlled according 

to Volume I, Section 8.3 Control of Management System Documents 

and are readily available.

D. Laboratory methods are selected to meet the customer’s need as 

addressed in Volume I, Section 7.1 Review of Requests, Tenders and 

Contracts. The laboratory ensures that it uses the latest valid version of 

analytical methods unless not appropriate or possible to do so. 

E. Standard methods are those published by international, regional, or 

national standards-writing bodies; by reputable technical organizations; 

in legal references; and FDA published methods. FDA “official” methods 

are those in compendia specified in the FD&C Act and prescribed in the 

CFR and methods in applications and petitions that have official status 

are included. These methods include those in the United States 

Pharmacopeia, National Formulary, Homeopathic Pharmacopeia of the 

United States, Official Methods of Analysis of AOAC INTERNATIONAL 

or any supplement of any of them, American Public Health Association 
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(APHA) Compendium of Methods for the Microbiological Examination of 

Foods, FDA compliance programs, the Pesticide Analytical Manual 

(PAM), the Food Additives Analytical Manual, the Food Chemicals 

Codex, FDA Bacteriological Analytical Manual (BAM), FDA Macro 

analytical Procedures Manual (MPM), and ORA Laboratory Information 

Bulletins (LIBs) that are included in compliance programs and special 

assignments. Standard methods are preferred for use and are verified 

for use in the laboratory. A standard method may be supplemented with 

additional details in the form of a laboratory procedure to ensure

consistent application. Those methods specified by the manufacturer of 

the equipment are considered as standard methods. Standard methods 

are verified according to the procedure, MAN-000037 Volume II, 

Section 2, ORA-LAB.5.4.5 Methods, Method Verification and Validation.

F. When the customer does not specify the method to be used, a standard 

method is preferred for use. If a standard method is not found, the 

laboratory may use either a non-standard method or modify a method 

for use with the concurrence of the customer. The non-standard or 

modified method is validated according to Volume I, subsection 7.2.2 

Validation of Methods.

G. The laboratory informs the customer when the method proposed by the 

customer is an incorrect choice or the incorrect revision for the intended 

purpose. This is done as part of contract review addressed in Volume I, 

Section 7.1 Review of Requests, Tenders and Contracts. 

7.2.2. Standard methods are verified according to the procedure, MAN-000037

Volume II, Section 2, ORA-LAB.5.4.5 Methods, Method Verification and 

Validation.

Records of the verification are retained by the ORS laboratories. If the 

method is revised by the issuing body, verifications are repeated to the 

extent necessary.

7.2.3. Non-standard methods are those methods not taken from authoritative, 

validated sources. A nonstandard method has not undergone validation, 

such as a collaborative study or process to evaluate the method’s 

performance capabilities.

Non-standard methods are selected for use when a customer request 

cannot be addressed with the use of a standard method. Such methods are 

subject to agreement with the customer and a clear specification of the 

customer's work requests, including the purpose of the test, is made. This 
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process is described for contract amendments in Volume I, subsection 7.1 

Amendments to Contracts with laboratory management concurrence. Nonstandard methods are validated according to Volume I, subsection 7.2.2 

Validation of Methods.

7.2.4. When a laboratory develops methods for its own use refer to MAN-000037

Volume II, Section 2, ORA-LAB.5.4.5. This procedure provides the planned 

activities, identification of competent personnel, and resources. Method 

development plans are reviewed periodically to confirm the customer’s 

requirements are still being met. Any modifications to the development 

plan shall be approved and authorized. Laboratory developed methods 

adopted by the laboratory are used if they are validated according to 

Volume I, subsection 7.2.2 Validation of Methods.

7.2.5. Deviations from test methods are documented, technically justified, 

authorized, and where circumstances call for it, accepted by the customer 

according to MAN-000044 Volume II, Section 2, ORA-LAB.5.10 Reporting 

Laboratory Data.

7.2.6. Validation of Methods

A. The laboratory validates non-standard methods, laboratory developed 

methods, and modified standard methods including use outside the 

intended scope or otherwise modified. Validation is conducted to 

confirm that the methods are fit for the intended use, relevant to the 

customers’ needs, and consistent with specified requirements. The 

validation is as extensive as is necessary to meet the needs of the 

given application or field of application.

B. When changes are made to a validated method, the influence of such 

changes shall be determined and where they are found to affect the 

original validation, a new method validation shall be performed.

C. The validation process addresses the needs of the given application or 

field of application. The laboratory analyst records the results obtained 

according to the procedure, MAN-000037 Volume II, Section 2, ORALAB.5.4.5 Methods, Method Verification and Validation. The validation 

results include a statement as to whether the method is fit for the 

intended use. The needs of the customer define the intended use of the 

method. The attributes and data quality objectives include but are not 

limited to: 

1. accuracy,
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2. precision, 

3. specificity, 

4. detection limit, 

5. limit of quantitation, 

6. linearity, 

7. range, and 

8. ruggedness or robustness. 

D. If all the data quality objectives are met as indicated by the data 

collected, the method is considered as validated.

E. The following records are maintained for each validation:

1. the validation procedure used.

2. specification of the requirements 

3. determination of the performance characteristics of the method.

4. results obtained.

5. a statement on the validity of the method, detailing its fitness for 

the intended use.

7.3. Sampling

A. ORS laboratories do not routinely perform sampling in the sense of 

collecting a representative sample from a product lot to represent the whole.

B. Sample Collection Conducted by the Customer: Most test samples are 

obtained and sent to the laboratory by ORA inspectional staff. Instructions 

for sample collection, including methods and sampling plans, by such 

personnel are provided in the Investigations Operations Manual (IOM) 

Chapter 4. 

C. Occasionally, laboratory personnel are consulted about sampling 

parameters such as sample type or size or guidance for a sampling or 

analytical need. The ORS laboratories, however, exert no direct control over 

such sampling and do not have responsibility for sampling.

D. Sampling data (i.e., date and time of sampling, description, environmental 

conditions, collector identification, etc.) required as part of testing is 

included in the Collection Report accompanying the request in FACTS. 

When the request in entered, a unique identifier is assigned to the sample. 

E. Sampling conducted by ORS laboratories involves for the most part those 

analyses that call for a portion or aliquot of the total sample received by the 
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laboratory to be analyzed. Generally, this calls for mixing or preparing of 

samples to assure homogeneity before portions are taken for analysis. 

Sample preparation and subsampling protocols are found in the analytical 

methods, compliance programs, and assignments.

7.4. Handling of Test or Calibration Items

The laboratory procedure in MAN-000042 Volume II, Section 2, ORA-LAB.5.8 

Sample Management, describes the receipt, processing, protection, storage, 

retention, and disposal of samples. This procedure also provides the details for 

handling and protecting test items from deterioration, loss or damage during 

storage and processing. The laboratory has arrangements for storage and security 

that protect the condition and integrity of samples. Sample security arrangements 

apply both in the laboratory and in the custodial areas.

7.4.1. The laboratory has a system for uniquely identifying samples. The sample 

number is used to track its progress from the time the sample is collected in 

the field until the analysis is completed and the sample is disposed. The 

sample number is also used to provide traceability between the sample and 

the data. The numbering system also provides traceability during transfer of 

samples within the laboratory and between ORS laboratories in the case of 

administratively transferred samples. The identification system is 

described in MAN-000042 Volume II, Section 2, ORA-LAB.5.8 Sample 

Management.

7.4.2. When samples received do not meet established acceptance criteria, for 

example, contract/program specifications, analysis requested, 

abnormalities or departures from normal or specified conditions, and chain 

of custody criteria, these deviations are recorded according to MAN000042 Volume II, Section 2, ORA-LAB.5.8 Sample Management. The 

customer is consulted prior to commencement of analysis for further 

instructions. Communication with the customer is recorded in accordance 

with SOP-000285Sample Feedback Report Process. 

Sample abnormalities or departures are also noted on the analytical 

worksheet.

7.4.3. When samples and calibration items have specific environmental 

conditions, those conditions are maintained, monitored and recorded. 

Monitoring records are collected according to established procedures. 

These activities are conducted according to the policies stated in Section 

6.3 Facilities and Environmental Conditions.

7.5. Technical Records
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7.5.1. Technical records for all activities that contribute to data reporting, 

depending on the type of analysis, include the original observations, 

derived data, calculations, standard preparation, instrument printouts, and 

results. These records contain the date each activity is completed and the 

identity of all persons who perform each activity throughout the process, 

including those who review the data and results. 

7.5.2. Observations, data, and calculations are recorded at the time they are 

made and are identifiable to the activity performed.

7.5.3. The records of each test contain sufficient information to repeat the test 

under conditions as close as possible to the original. This information 

includes environmental conditions that affect the test and factors that affect 

the measurement results and its associated measurement uncertainty.

7.5.4. Staff records, equipment calibration, and verification reports are retained in 

accordance with the laboratory’s control of records procedure. These 

records contain sufficient information to establish an audit trail. The 

requirements for an audit trail in laboratory records are outlined in MAN000032 ORA-LAB.4.13 Record and Data Management.

7.5.5. Data is reported electronically in FACTS and/or scanned and uploaded into 

Compliance Management Services (CMS), both ORA web-based 

programs. 

7.5.6. The collection report in FACTS identifies the personnel responsible for 

sampling. The FDA form FD-431a includes the identity of the personnel 

responsible for performance of each test and for checking the results.

7.5.7. ORS laboratories ensure changes to technical records can be tracked to 

the previous version or to original observations. Both the original and 

amended data and files are retained, including the date the record was 

changed, an indication of what was changed and the person responsible 

for the alteration.

7.6. Evaluation of Measurement Uncertainty

7.6.1. Uncertainty Components

When estimating the uncertainty of measurement, all important uncertainty 

components are recorded in the uncertainty records for each determination 

and test technology as addressed in the procedure MAN-000038 Volume II, 

Section 2, ORA-LAB.5.4.6, Estimation of Uncertainty of Measurement.

7.6.2. Procedure for Calibration Activities
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ORS laboratories do not perform calibration activities. At such time that 

calibration activities are performed, the ORS laboratories are to address the 

requirements of ISO/IEC 17025:2017.

7.6.3. Procedure for Testing Activities

The laboratory has a procedure, MAN-000038 Volume II, Section 2, ORALAB.5.4.6, Estimation of Uncertainty of Measurement, to estimate the 

uncertainty of measurement for testing activities. 

The application of details in cases where the nature of the test method may 

preclude rigorous, metrologically and statistically valid, calculation of 

uncertainty of measurement is addressed in the procedure.

An attempt is made to identify all the components of uncertainty and make a 

reasonable estimation of the measurement uncertainty. This estimation is 

based on knowledge, experience, and validation data of the performance of 

the method and on the measurement scope. If needed as a part of the 

laboratory data, the uncertainty estimation is reported according to the 

procedure, MAN-000038 Volume II, Section 2, ORA-LAB.5.4.6 Estimation of 

Uncertainty of Measurement.

7.7. Ensuring the Validity of Results

7.7.1. Quality Control Procedures

The laboratory has quality control procedures to validate the results of tests 

undertaken according to MAN-000043 Volume II, Section 2, ORA-LAB.5.9 

Assuring the Quality of Test Results.

The monitoring data is recorded in such a way that trends may be detected, for 

example, statistical process control charts. Monitoring activities are planned 

and evaluated according to MAN-000043 Volume II, Section 2, ORA-LAB.5.9 

Assuring the Quality of Test Results. Monitoring techniques may include, but 

are not limited to, the following:

A. Scheduled use of certified reference materials or quality control 

materials.

B. Use of alternative instrumentation that has been calibrated to provide 

traceable results.

C. Functional check(s) of measuring and testing equipment.

D. Use of check or working standards with control charts.

E. Intermediate checks on measuring equipment.

F. Replicate tests using the same or different methods.
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G. Retesting of reference materials and retained customer samples. 

H. Correlation of results from tests conducted for different characteristics of 

a sample. 

I. Review of reported results.

J. Scheduled participation in interlaboratory comparison or proficiencytesting and calibration programs as described in SOP-000935 National 

Check Sample Program.

K. Testing of blind samples.

7.7.2. ORS laboratories participate in proficiency testing programs and/or 

interlaboratory comparisons other than proficiency testing, where available 

and appropriate. 

7.7.3. The laboratory has defined the criteria for quality control data and performs 

analysis by such means as control charting. When data is found to be 

outside the established criteria, action is taken in accordance with MAN000029 ORA-LAB.4.9 Control of Nonconforming Work. 

7.8. Reporting Results

7.8.1. General Requirements

Test reporting is addressed in the ORA Laboratory Manual procedure found in 

MAN-000044 Volume II, Section 2, ORA-LAB.5.10 Reporting Laboratory Data. 

This procedure gives the details for reporting data using consistent reporting 

formats for laboratory worksheets. Results are reported on analytical 

worksheets and in FACTS and/or LIMS.

A. Laboratory results are reviewed and authorized for release by 

supervisors or designees. Reports are reviewed for accuracy, clarity 

and objectivity. Laboratory management expresses its opinion and 

interpretation of the compliance or non-compliance of the results 

through the laboratory classification assigned to each sample. This 

laboratory classification is recorded in FACTS and/or LIMS and may be 

recorded on the FDA form FD-465 as well. The laboratory 

classifications are defined in the ORA Laboratory Manual Vol. III, 

Section 3.

B. Laboratory reports, depending on the type of analysis, include the 

original observations, derived data, calculations, standard preparation, 

instrument printouts, and results. These reports are retained until closed 

in FACTS and/or LIMS and final review is performed. An electronic test 
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report is in FACTS and/or LIMS. Staff records, equipment calibration, 

and verification reports are retained in accordance with the laboratory’s 

control of records procedure.

C. The records contain sufficient information to establish an audit trail.

D. The records of each test contain sufficient information in order to repeat 

the test under conditions as close as possible to the original. This 

information includes factors that affect uncertainty and any 

environmental conditions that affect the test.

E. The collection report in FACTS identifies the personnel responsible for 

sampling. The FDA form FD-431a includes the identity of the personnel 

responsible for performance of each test and for checking the results.

F. Test reporting is addressed in the procedure found in MAN-000044

Volume II, Section 2, ORA-LAB.5.10 Reporting Laboratory Data. This 

procedure gives the details for reporting data using consistent reporting 

formats for laboratory worksheets. 

7.8.2. Common Requirements for Reports (test, calibration, or sampling)

A. Format

The format for laboratory worksheets is designed to accommodate the type 

of test conducted to minimize the possibility of misunderstanding or misuse. 

The worksheet format is described in MAN-000044 Volume II, Section 2, 

ORA-LAB.5.10 Reporting Laboratory Data.

Subcontracting laboratories are not utilized by ORS laboratories, therefore, 

there is no such data found for incorporation in the analysis report to the 

customer.

B. Data Provided by Customer

Analysts describe the sample as received, including any information 

provided by the customer, on the sample worksheet in the description of 

sample block (Block 7). Unless noted in the sample worksheet, results 

apply to the sample as received. 

7.8.3. Specific Requirements for Test Reports

A. The following information is included in test reports for the interpretation 

of the test results:
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1. Information on test conditions, such as environmental conditions.

2. Where relevant, a statement of conformance or non-conformance 

with specifications.

3. The measurement uncertainty presented in the same unit as the 

measurand, or in a term relative to the measurand when:

4. It is relevant to the validity of the test results.

5. A customer requires it, or;

6. The measurement uncertainty affects conformity to a specification 

limit.

7. Opinions and interpretations as detailed in Volume I, Section 7.8.7; 

and,

8. Additional information that may be requested by methods, 

customers, or groups of customers.

7.8.4. Specific Requirements for Calibration Certificates

ORS laboratories conduct in-house calibration activities on measuring and test 

equipment only and, therefore, do not issue calibration certificates. In-house 

calibrations are documented by a report, or sticker, or other suitable method.

7.8.5. Reporting Sampling – specific requirements

In addition to the instructions listed in Sections 7.8.1 General Requirements 

and 7.8.3. Specific Requirements, sampling information and conditions are 

posted to the laboratory for review on the FACTS sample collection record.

7.8.6. Reporting Statements of Conformity

Statements of conformity reported on worksheets clearly identify:

A. The results the statement applies to.

B. Which specifications or standards were met, or not met.

7.8.7. Decision Rules

Statements of conformity to a specification or standard require the use of a 

decision rule to consider the uncertainty associated with method. Most 

decision rules used by ORS laboratories are documented in the compliance 

programs or standard methods. When the decision rule is not provided, the 

laboratory will use simple acceptance, where the acceptance level equals the 

tolerance level or customer requirements. Uncertainty measurements are 

available upon request.
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7.8.8. Reporting Opinions and Interpretations

Laboratory management expresses its opinion and interpretation of the 

compliance or non-compliance of the results through the laboratory 

classification assigned to each sample. This laboratory classification is 

recorded in FACTS and/or LIMS and may be recorded on the FDA form FD465 as well. The laboratory classifications are defined in the FDA Data Codes 

Manual.

Records are maintained of conversations expressing opinions and 

interpretations about a sample with the customer.

7.8.9. Amendments to Reports

Material amendments to analytical findings after issue are made only in the 

form of an additional document. They are flagged “Additional Analyses” in 

accordance with procedure MAN-000044 ORA-LAB.5.10 Reporting Laboratory 

Data of Volume II. Amendments are to meet the same reporting criteria. Any 

changed information is clearly identified and where appropriate, the reason for 

the change is included in the report.

Related Procedures/References

• MAN-000044 ORA Lab Manual, Volume II, ORA-LAB.5.10 Reporting 

Laboratory Results.

• FDA Regulatory Procedures Manual.

7.9. Complaints

7.9.1. The ORS laboratories have a complaint process describing the handling of 

complaints received from any party. See MAN-000028 ORA-LAB.4.8 

Complaints and Feedback. In addition to the resolution of these 

complaints, improvement in the area of concern is addressed and 

implemented in most cases.

7.9.2. The process for handling complaints is documented in MAN-000028 ORALAB.4.8 and is available to any interested party on the FDA internet site. 

The laboratory confirms whether the complaint relates to laboratory 

activities that it is responsible for and, if so, then addresses it.

7.9.3. The process for handling complaints includes the following:

A. Description of the process for receiving, validating, investigating the 

complaint, and deciding appropriate actions to respond to it.

B. Tracking and recording complaints, including actions taken to resolve 
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them.

C. Ensuring appropriate action is taken.

7.9.4. The laboratory receiving the complaint will gather all information required to 

investigate, validate, address, and review the complaint and its outcome. 

7.9.5. When possible, the laboratory will acknowledge receipt of the complaint, 

provide progress reports with the outcome of resolution, and formal notice 

of completion to the complainant.

7.9.6. Communications to the complainant is addressed in MAN-000028 ORALAB.4.8.

7.10. Nonconforming Work

7.10.1. The ORS laboratories have a control of non-conforming work procedure 

that is implemented when any aspect of their activities, or the results of this 

work, does not conform to requirements of the management system, 

testing methods, or the requests of the customer. This procedure 

addresses the following elements:

A. responsibilities and authorities for the management of identified nonconforming work to include taking actions such as the halting of work 

and/or the withholding of test reports based upon risk levels established 

by the laboratory

B. actions are based upon the risk levels established by the laboratory.

C. an evaluation of the significance of non-conforming work including an 

impact analysis on previous results and, if necessary, recall of work with 

notification to the customer

D. remedial action taken, together with any decision about the acceptability 

of the non-conforming work

1. The customer is notified if investigations show that nonconformances have affected work performed for or data reported to 

the customer. This notification is documented.

E. responsibility for authorizing the resumption of work.

7.10.2. Records of nonconforming work and actions taken are maintained in QMiS.

7.10.3. If the non-conforming work could recur, or there are other significant 

problems identified, the corrective action procedures in Volume I, Section 
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8.7 Corrective Action are promptly followed.

Related Procedures/References

• MAN-000029 ORA Laboratory Manual, Volume II, ORA-LAB.4.9 

Control of Nonconforming Work

7.11. Control of Data and Information Management

7.11.1. ORS laboratories have access to the data and information needed to 

perform laboratory activities through various electronic records 

management systems including FACTS, LIMS, QMiS, and paper records 

maintained according to MAN-000032 ORA-LAB.4.13 Record and Data 

Management.

7.11.2. ORA information management system applications used for the acquisition, 

processing, recording, reporting, storage, or retrieval of data are validated 

prior to introduction by the FDA’s Office of Information Systems 

Management.

If computer software is developed by the user, its development is 

authorized, documented in detail and algorithms are validated prior to 

implementation.

Changes to laboratory software configuration or modifications to 

commercial off-the-shelf software are also authorized, documented, and 

validated prior to use.

7.11.3. ORS laboratories have processes for the protection of data to include, but 

not limited to data integrity, data confidentiality during entry, collection, 

storage, transmission, and processing. The processes also ensure 

safeguards are in place to prevent unauthorized access to or amendment 

of records.

Information management system failures are recorded, and appropriate 

immediate and corrective actions are taken.

7.11.4. Laboratory information systems managed and maintained off-site meet all 

applicable requirements of ISO 17025:2017.

7.11.5. Instructions, manuals and reference data relevant to the laboratory 

information systems are readily available to personnel through the 

document control process (see section 8.3).

7.11.6. Calculations and data transfers are reviewed before the data is reported. 
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All changes are identified and verified where they occur. This process is 

detailed in the procedure for laboratory quality control identified in Volume 

I, Section 7.7 Ensuring the Validity of Results.

8. Management System Requirements

8.1. Options

8.1.1. General

ORS laboratories have established, documented, implemented, and 

maintained a management system capable of supporting and demonstrating 

the consistent achievement of the requirements of ISO/IEC 17025:2017 to 

assure the quality of laboratory results. In addition to meeting the requirements 

outlined in sections 4 to 7 of this document the Standard requires ORS 

laboratories implement a management system in accordance one of the two 

following options.

8.1.2. Option A

ORS laboratories follow the requirements for option A, outlined in the following 

sections 8.2 to 8.9.

8.1.3. Option B

Option B of ISO/IEC 17025:2017 addresses minimal requirements for 

laboratories with a separate management system either certified to or at least 

structured to the requirements of ISO 9001. ORS laboratories do not fall within 

this category.

8.2. Management System Documentation (Option A)

8.2.1. Management System Policy

Mission

ORA’s mission statement states “ORA protects consumers and enhances 

public health by maximizing compliance of FDA regulated products and 

minimizing risk associated with those products”. ORS laboratories are 

committed to providing testing that meets both the needs of the customers and 

the requirements of ISO/IEC 17025:2017 and to continually improve the 

effectiveness of the management system. Testing results are reported within 

stated limits of accuracy, precision, and detection limits as described in the 

methods used for analysis. 
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8.2.2. Commitments to Quality Issued by Director, Office of Regulatory 

Science

A. Good Professional Practice and the Quality of Testing

ORS laboratories are committed to the Standards of Ethical Conduct 

which define the obligations of public service issued under Executive 

Order 12674. Testing is conducted per the policies stated in Volume I, 

subsections 3 and this section. The laboratory management and 

personnel are committed to performing quality activities to assure 

integrity, accuracy, precision, reliability, and timeliness of the data.

B. Standard of Service

The laboratory’s standard of service for the testing program is defined 

by the ISO/IEC 17025:2017 requirements, FDA regulatory needs 

included as part of the laboratory methods, and the following:

1. Established and maintained documented procedures for laboratory 

operation based upon consensus methods for testing. Methods are 

specified or cited in the compliance program and compendiums, or 

by the customer. In some cases, testing and procedures as 

established by the instrument manufacturer are used.

2. Sample handling and management procedures to maintain integrity 

of both the samples and the documentation to support the analytical 

data.

3. Maintenance of records in such manner that facilitates retrieving 

them later. Records are maintained in the analyst worksheet packet 

or web application by sample number. Records may be archived onor off-site depending on the home division of the collector or in a 

web application. Archival retention periods are stated in the 

laboratory’s record management procedure and are in accordance 

with the agency’s established record retention schedule.

4. Employment of qualified and trained personnel to perform the tasks 

to support the laboratory objectives. Competency demonstrations by 

technical personnel conducting laboratory methods are conducted 

and documented.

5. Routine maintenance of quality control data to support testing results 

by demonstrating that measurement processes are maintained in 

statistical control. Accuracy and precision control charts are used to 

monitor performance.
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6. Maintenance of an instrument calibration program that provides 

measurement traceability to International System of Units (SI) units. 

This is accomplished with the use of national, international, or 

industry accepted standards of measurement.

C. ORS laboratory personnel follow the policies included in this Volume, 

the processes described in their local operating procedures, and the 

processes described in laboratory methods referenced in this Volume.

D. The sections in this Volume describe elements and reference 

procedures that outline the management system established to 

accomplish the mission of the laboratory.

8.2.3. The management system process and procedures as defined in this 

manual maintain the integrity of the management system for consistent 

operations when changes such as a change in the structure of the 

organization or management, or a change in a policy or procedure are 

made. 

Primary consideration in all policies, procedures, and objectives is given 

toward retaining personnel competence and impartiality. 

8.2.4. The policies for operation of the laboratory management system are 

established to address the requirements of ISO/IEC 17025:2017. ORS 

laboratories are committed to laboratory accreditation per the requirements 

of ISO/IEC 17025:2017. 

The implementation of the quality policies is evidenced by the way work 

activities are conducted. Implementation of the management system 

procedures is evidenced by the generation of required records. The audit 

and management review activities are the mechanisms that are used to 

monitor the implementation effort of the laboratory management system.

Evidence of management’s commitment to the management system and its 

continual improvement in effectiveness is demonstrated by but not limited 

to participation of managers in the management reviews, performance of 

internal audits, proficiency testing, and the analysis of quality control 

samples.

8.2.5. Management system procedures supporting quality policies are cited in the 

Related Procedures/References at the end of each section of this Volume. 

Where needed, each laboratory shall have procedures to implement the 

quality policies at the local level and include these procedures in the 

document control system. All documentation, processes, systems, records, 
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related to the fulfillment of the requirements of ISO/IEC 17025:2017 shall 

be included in, referenced from, or linked to the management system.

8.2.6. All laboratory employees involved in laboratory activities have access to 

approved and controlled consensus standards, instrument manufacturers’ 

manuals, and procedures for reference ensuring consistent application and 

validity of activities that contribute toward results reported.

8.3. Control of Management System Documents (Option A)

8.3.1. Changes to management system documents are made per the laboratory 

document control procedure and involve periodic revisions of this Volume.

A. The operational procedures for ORS laboratories are controlled as 

described in MAN-000026 ORA-LAB.4.3 Document Control and 

Management.

B. The document control and management procedure describes the 

process for controlling quality documents that form part of the laboratory 

management system. The quality documents include those required for 

the generation of laboratory data. These documents include those 

published by the laboratory and those published externally. Documents 

of external origin include regulations, standards, test methods, 

instructions, and manuals.

C. Control of electronic management system documents and data is 

addressed in section 7.11.

8.3.2. Document control requirements:

A. Documents issued to personnel in the laboratory as part of the 

management system are reviewed for adequacy and approved by 

authorized personnel prior to issue in accordance with MAN-000026

ORA-LAB.4.3 Document Control and Management procedure.

B. Documents are reviewed per an established schedule and revised as 

necessary to ensure continuing suitability and conformance with the 

management system and ISO/IEC 17025:2017 requirements. These 

reviews should include an assessment of reference documents and 

pertinent background information.

C. Altered or new text is identified either in the document, document 

change history section, on a cover page, redline file, or in attachments. 

Changes can be described in general terms since the details can be 

demonstrated in the archived document. Document revision is recorded 

on each document and tracked within QMiS.
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D. Authorized management system documents and external documents 

are available at locations where operations essential to the effective 

functioning of the laboratory are performed. Distribution and locale of 

these documents is controlled.

E. A document control header as described in the document control and 

management procedure uniquely identifies management system 

documents generated by the laboratory. Such identification includes the 

revision status, identification number and inclusive pagination. 

F. The unintended use of obsolete documents is prevented, and suitable 

identification is applied to them if they are retained for any purpose. 

8.4. Control of Records

8.4.1. ORS laboratories maintain records according to MAN-000032 ORALAB.4.13 Record and Data Management to sustain objective evidence 

showing fulfilment of the requirements of the quality system. These records 

are required to be legible and readily identifiable for retrieval.

8.4.2. Retention time, archival, and disposal of ORS Laboratory records are in 

accordance with SMG 3291.1 Records Management Policy and existing 

FDA and ORA record retention schedules.

Quality record storage and protection are maintained in QMiS or recorded 

within each laboratory’s individual records file plan.

Internal access to records is controlled through various methods, such as, 

but not inclusive of, password protected storage, both electronic and 

physical, provided to authorized personnel to maintain confidentiality. 

Access from entities outside FDA is governed by statutes within the 

Freedom of Information Act (FOIA) July 4,1966, President Obama’s 

Freedom of Information Act Memorandum dated January 21, 2009, and 

Attorney General Holder’s Freedom of Information Act Guidelines, March 

19, 2009.

Additional requirements regarding technical records are addressed in 

section 7.5 and control of electronic records is covered in section 7.11 of 

this document.

8.5. Actions to Address Risks and Opportunities

8.5.1. Top management in each ORS Laboratory meet regularly to assess risks 

and opportunities associated with all laboratory activities to:

A. Assure the management system achieves its intended results.
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B. Enhance opportunities to achieve the purpose and objectives of the 

laboratory.

C. Prevent, or reduce negative impacts and potential failures in laboratory 

activities.

D. Achieve improvement

E. Examples of areas evaluated consist of the following, although the list is 

not all inclusive:

1. Turnaround times for data reporting

2. Training and competency

3. Structure to ensure impartiality of personnel

4. Equipment issues

5. Program requirements

6. Facilities/Environment

7. Effectiveness of corrective and preventive actions

8. Outcomes of internal audits

9. Complaints

10.Processes to ensure confidentiality

8.5.2. Plans, final evaluation, actions and implementation of actions, 

improvement, and assurance of intended actions are outlined in section 

8.9 Management Reviews.

8.5.3. Actions taken to address risks and opportunities are proportional to the 

potential impact on the validity of laboratory results.

8.6. Improvement

8.6.1. The effectiveness of the laboratory’s management system is improved by 

using the following activities: internal audits; management reviews; analysis 

of quality control data; corrective actions; preventive actions (see MAN000031 ORA-LAB.4.12); the quality policy; and the quality objectives.

8.6.2. The laboratory seeks customer feedback on their services and general 

performance. Records of the comments, both positive and negative, are 

maintained and are considered for identifying management system 

improvements during reviews performed by laboratory management.

8.7. Corrective Actions
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Document Number:

MAN-000025

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Title: 

ORA Lab Manual Vol. I - Manual of Quality Policies for ORA Regulatory 

Laboratories (ORA-LAB.QM)

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8.7.1. Each ORS laboratory designates the authorities for implementing corrective 

action when one of the following is identified: 

A. non-conforming work,

B. departures from the policies and activities outlined within the 

management system, and

C. departures from required technical operations.

8.7.2. When a non-conformance is identified, the corrective action chosen 

addresses the magnitude of the non-conformance and the risk attributed to 

the non-conformance.

A. Immediate action is implemented to correct a nonconformity and 

address the consequences..

B. An evaluation is performed to determine the cause(s), a history of 

similar issue(s), potential for recurrence, and the need for action to 

eliminate the problem to prevent recurrence.

C. Corrective actions are determined and implemented based upon this 

evaluation.

D. A review of the effectiveness of corrective actions is performed.

E. If necessary, updates for risks and opportunities are determined during 

planning. 

F. Essential changes discovered during the corrective action investigation 

are implemented within the management system, where necessary.

8.7.3. Corrective actions are appropriate to the effects of the nonconformities 

encountered.

8.7.4. Corrective actions are recorded, to include the nature of the 

nonconformities, cause(s) and subsequent actions taken, including the 

results of any corrective action.

Related Procedures/References

• MAN-000030 ORA Laboratory Manual, Volume II, ORA-LAB.4.11 

Corrective Action

8.8. Internal Audits

8.8.1. General

Internal audits are conducted according to a schedule included in the 

laboratory’s audit procedure. Internal audits are conducted of activities to verify 
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Office of Regulatory Science

Document Number:

MAN-000025

Revision #: 05

Revised:

14 Jun 2022

Title: 

ORA Lab Manual Vol. I - Manual of Quality Policies for ORA Regulatory 

Laboratories (ORA-LAB.QM)

Page 44 of 46

For the most current and official copy, check QMiS.

that operations continue to conform to the requirements of the management 

system and ISO/IEC 17025:2017.

An internal audit process is used to evaluate the effectiveness of the 

management system established for laboratory operations.

Note: The laboratory information management system is audited at least once 

per accreditation cycle.

8.8.2. Audit Program

A. The internal audit program is defined in MAN-000033 ORA-LAB.4.14 

Audits. The program takes into consideration the importance of the 

laboratory activities concerned, changes affecting the laboratory, and 

the results of previous audits.

B. The QSM defines the audit criteria and scope for each audit in an audit 

plan.

C. Results of the audits are reported to laboratory management.

D. When audit findings cast doubt on the effectiveness of operations or the 

correctness or validity of the laboratory’s test or calibration results, the 

laboratory implements appropriate correction and corrective actions in a 

timely manner according to MAN-000030 ORA-LAB.4.11 Corrective 

Action.

E. The area of activity audited, the audit findings, and corrective action that 

arise from them are recorded according to the laboratory’s audit 

procedure.

Related Procedures/References

• MAN-000033 ORA Laboratory Manual, Volume II, ORA-LAB.4.14 Audits.

• MAN-000030 ORA Laboratory Manual, Volume II, ORA-LAB.4.11 

Corrective Action.

8.9. Management Reviews

A management review is conducted by the laboratory’s executive management at 

least once each fiscal Year; however, can be conducted more often according to 

planned intervals determined by each ORS laboratory.

This review is conducted to ensure continuing suitability, adequacy, and 

effectiveness based upon information related to the inputs and outputs of 

laboratory activities and operations and stated policies and objectives.
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Office of Regulatory Science

Document Number:

MAN-000025

Revision #: 05

Revised:

14 Jun 2022

Title: 

ORA Lab Manual Vol. I - Manual of Quality Policies for ORA Regulatory 

Laboratories (ORA-LAB.QM)

Page 45 of 46

For the most current and official copy, check QMiS.

Reviews of nonconforming work, personnel, and customer feedback are performed 

during management review to identify trends.

Related Procedures/References

• MAN-000034 ORA Laboratory Manual, Volume II, ORA-LAB.4.15 

Management Review

Document History

Revision

#

Status*

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

2.0 R 5/2/2014 LMEB LMEB

03 R 08/13/2019 LMEB LMEB

04 R 01/22/2021 LMEB LMEB

05 R

REFER TO 

QMIS

LMEB LMEB

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

Change History

Revision 

#

Change

2.0

1.0– deleted “2005”

4.13, 4.14, & 4.15 e. – changed Sections 1300.1-1316.4 to Volume I, Section 1300

4.15 a. – deleted OPM manual reference and added OPM website

4.2.2 b. – added web application and added to last sentence on 3rd bullet

4.3.2.3 – revised 1st paragraph

4.13.1.2 – revised

4.13.2.1 – added “and/or LIMS”

5,8.3, 5.10.1., 5.10.2., & 5.10.5 – added reference to LIMS

03 All section numbering and content updated to reflect changeover from ISO/IEC 

17025:2005 revision requirements to 2017 version requirements
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Office of Regulatory Science

Document Number:

MAN-000025

Revision #: 05

Revised:

14 Jun 2022

Title: 

ORA Lab Manual Vol. I - Manual of Quality Policies for ORA Regulatory 

Laboratories (ORA-LAB.QM)

Page 46 of 46

For the most current and official copy, check QMiS.

Revision 

#

Change

04

5.6.5 and 5.6.6 – Added numbering to these two paragraphs and in 5.6.5, replaced 

“FDA Division of Ethics and Integrity” with the more generic “FDA procedures and 

policies”

7.8.2.2 – clarified that results in worksheets apply to the sample as received

7.8.6.1 – clarified the Decision Rule requirement with steps to take when a decision 

rule is not provided.

7.8.6.2 – Deleted Bullet C.

8.8.1 – Added AOAC requirement for internal audit of lab information management 

system.

8.9 – Added AOAC requirement for review of nonconforming work and other items 

during management review

05

Obsolete references have been removed. All remaining references and document ID numbers

were updated to ensure adequate searches by FDA internal users within QMiS and links 

within document were verified or updated as needed for FDA internal users. Additions or 

Changes are highlighted within document. Reformatted. 

Attachments

None