FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Office of Regulatory Science

Document Number:

MAN-000033

Revision #: 04

Revised:

07 Oct 2022

Title: 

ORA Lab Manual Vol. II - Audits (ORA-LAB.4.14) Page 1 of 13

For the most current and official copy, check QMiS.

Sections in This Document

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

Scope .......................................................................................................................................2

Responsibility............................................................................................................................2

Background...............................................................................................................................3

References ...............................................................................................................................3

Procedure .................................................................................................................................3

6.1. Internal Audit Process....................................................................................................3

6.2. Quality Management System Audits ..............................................................................4

6.3. Process/Product Audits..................................................................................................5

6.3.1. Worksheet Review Audits ................................................................................5

6.3.2. On-Site Review ................................................................................................6

6.3.3. Oral Review (optional) .....................................................................................6

6.3.4. Sample Accountability Review.........................................................................6

6.3.5. Laboratory Controls Review Audit ...................................................................6

6.4. Internal Audit (Follow-up/Focused) ................................................................................7

6.5. Training Requirements...................................................................................................7

6.6. External – Second Party Audits .....................................................................................7

6.7. External – Third Party Audits .........................................................................................8

6.8. Nonconformances..........................................................................................................8

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

Records ....................................................................................................................................9

Supporting Documents ...........................................................................................................10

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

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

Attachments............................................................................................................................11

Attachment A - Example of how an audit schedule can be set up..........................................12

Attachment B - Example of an audit schedule organized by ISO/IEC 17025:2017 elements 

broken up across a fiscal year .....................................................................................13

Purpose

To provide guidance describing the audit program used to evaluate, monitor, 

and continually improve the quality management system. A properly 
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Office of Regulatory Science

Document Number:

MAN-000033

Revision #: 04

Revised:

07 Oct 2022

Title: 

ORA Lab Manual Vol. II - Audits (ORA-LAB.4.14) Page 2 of 13

For the most current and official copy, check QMiS.

performed assessment of the quality management system demonstrates the 

level of compliance with applicable standards and regulatory requirements. 

The information collected is used towards continual improvement of the 

system. 

Scope

This procedure applies to the Office of Regulatory Science (ORS) laboratories 

and laboratory work products and processes. This procedure directly 

concerns the laboratory’s quality assurance program.

Responsibility

A. Laboratory Management:

1. May assign auditors within the laboratory for internal audits

2. Allocate appropriate resources to conduct internal audits.

3. Ensures information and access is provided to auditors.

4. Informs staff of audit schedule

5. Ensures corrective action process is implemented in a timely fashion 

to address identified nonconformances.

B. Quality System Manager (QSM):

1. May serve as the lead auditor within the laboratory.

2. Coordinates audits and ensures auditors have adequate training and 

guidance.

3. Monitors audit activities, assembles report, and ensures results of 

the audits are reported to relevant management.

4. Monitors continual improvement processes.

5. Ensures corrective action process is initiated for identified 

nonconformances.

6. Acts as the Laboratory Point of Contact (POC) for External audits 

performed.

C. Auditor:

1. Reviews background information in preparation for audit.

2. Conducts audit in accordance with audit procedures and within

defined scope and/or established criteria.

3. Collects and documents objective evidence to support findings.

4. Coordinates schedule during audit with staff to be interviewed.
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Office of Regulatory Science

Document Number:

MAN-000033

Revision #: 04

Revised:

07 Oct 2022

Title: 

ORA Lab Manual Vol. II - Audits (ORA-LAB.4.14) Page 3 of 13

For the most current and official copy, check QMiS.

D. Staff:

1. Provide information as requested by auditors and participate in 

audits as necessary.

2. Provide input to responses for observations or non-conformances 

identified, as assigned. 

Background

NONE

References

A. ISO 19011:2002, Guidelines for Quality and/or Environmental 

Management Systems Auditing.

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

testing and calibration laboratories Section 8.8.

C. AOAC International Guidelines for Laboratories Performing 

Microbiological and Chemical Analysis of Food, Dietary Supplements, 

and Pharmaceuticals – An Aid to Interpretation of ISO/IEC 17025:2017; 

August 2018 

Procedure

6.1. Internal Audit Process

Internal quality system audits are performed on a predetermined schedule and as 

otherwise directed by management at the local level by trained staff from within the 

laboratory.

A. Audits shall be conducted in accordance with the local schedule 

outlined in the laboratory’s local procedures. 

B. The audit program shall address all elements of the management 

system, including laboratory activities and procedures. 

C. Internal Audits shall take into consideration the importance of the 

laboratory activities concerned, changes affecting the laboratory, and 

results of previous audits.

D. Audits should examine all aspects of the management system using 

both horizontal and vertical auditing techniques.
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Office of Regulatory Science

Document Number:

MAN-000033

Revision #: 04

Revised:

07 Oct 2022

Title: 

ORA Lab Manual Vol. II - Audits (ORA-LAB.4.14) Page 4 of 13

For the most current and official copy, check QMiS.

E. The QSM defines the audit criteria, scope, frequency, objectives, 

methods, etc. before the start of an audit using a risk-based approach.

F. Auditors conduct the audits and receive information through several 

means such as:

1. interviews with personnel,

2. examination of documentation,

3. observation of activities and conditions,

4. review of quality and technical records, and

5. use of checklists.

G. For all audits, objective evidence shall be obtained to support an 

observation.

H. When using a checklist, annotate it with specific objective evidence to 

support the evaluation of the satisfactory or unsatisfactory decision. 

The information collected on the checklist assists with report formulation 

and corrective action initiation.

I. The Quality Manager provides management with a summary report 

documenting the area of activity audited, the audit findings and on-thespot corrections. 

J. When evaluation of the audit findings cast doubt on the effectiveness of 

operations with its own management system or that the nonconforming 

work could reoccur, the laboratory shall take develop and implement 

timely corrective action.

K. Appropriate corrections and corrective actions are recorded and 

implemented without undue delay.

L. Follow-up audit activities shall verify and record the implementation and 

effectiveness of the corrective action plan. 

6.2. Quality Management System Audits

A. Audits of the entire Quality Management System are conducted at a 

minimum of once per year. These internal system audits are planned 

and scheduled by the Quality System Manager. This may be 

accomplished by piecing together many internal branch/section audits 

that represent the whole system. 

B. Areas audited include, but are not limited to:

1. laboratory information management systems

2. ISO/AOAC requirements.
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Office of Regulatory Science

Document Number:

MAN-000033

Revision #: 04

Revised:

07 Oct 2022

Title: 

ORA Lab Manual Vol. II - Audits (ORA-LAB.4.14) Page 5 of 13

For the most current and official copy, check QMiS.

3. methods and procedures.

4. personnel training and competency.

5. equipment management and maintenance.

6. laboratory proficiency testing.

7. quality control (QC) and QC charts.

8. workload and sample handling processes.

9. records and reports (work products).

10.standards, organisms, certified reference materials.

11.housekeeping; and 

12.laboratory environment.

6.3. Process/Product Audits

The information from specific process/product audits supports the completion 

of the comprehensive internal audit and shows performance throughout the 

year instead of only at one sampling point. Process/Product audits allow for 

earlier detection of problems, reduce propagation of error, and provide data for 

trend analysis if necessary. Use audit criteria and quality factors from the 

relevant procedures being audited.

The process audits described below are performed at each laboratory, at a 

frequency and schedule defined in the laboratory’s local procedure. A national 

quality factor checklist may be used to record the review. On the spot 

corrections are annotated on the form.

6.3.1. Worksheet Review Audits

The worksheet review audit is to verify the laboratory is following its 

procedures for the analysis and reporting of samples. This is a vertical audit in 

nature. A worksheet review audit may focus on a method; evaluate individual 

analyst performance; etc.

Worksheet review audits are carried out by the Branch Directors, Supervisors, 

and qualified analysts performing worksheet checks according to the 

laboratory sampling plan. The auditor should not have performed any part of 

the analysis or activities related to the worksheet(s) reviewed. The worksheet 

review audit frequency and schedule include both violative and non-violative 

samples.
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Office of Regulatory Science

Document Number:

MAN-000033

Revision #: 04

Revised:

07 Oct 2022

Title: 

ORA Lab Manual Vol. II - Audits (ORA-LAB.4.14) Page 6 of 13

For the most current and official copy, check QMiS.

6.3.2. On-Site Review 

The purpose of the on-site review is to witness a process being performed. 

The review may focus on a method, evaluate individual analyst performance, 

observation of sample handling processes by the sample evidence specialist; 

etc. Laboratory management performs these audits. 

The recommended frequency is at least one internal onsite review per analyst 

per year. The on-site review frequency and schedule takes into consideration 

the methods on the laboratory’s scope of accreditation.

6.3.3. Oral Review (optional)

The purpose of oral worksheet review is to verify that Analysts will be able to 

testify about their analyses as competent fact witnesses. Using the worksheet,

the Analyst reconstructs the test procedures and explains the results. Oral 

reviews should be performed by someone outside the supervisory group.

6.3.4. Sample Accountability Review

The purpose of the Sample Accountability Review is to ensure samples are 

handled correctly as they are processed through the laboratory. FACTS 

information is checked for accuracy and completeness. This includes the 

acceptance, storage, transfers, usage, and disposal. Laboratory management 

performs these audits. 

The recommended frequency is at least once per year or more frequent based 

on management assessments.

6.3.5. Laboratory Controls Review Audits

Responsibility for performing these audits shall be defined by the laboratory.

Laboratory control reviews are horizontal in nature and includes multiple areas 

and items within the laboratory.

6.3.5.1. Equipment Record Review

The purpose of the equipment audit is to check that appropriate records are 

present and accessible for equipment. 

The recommended frequency is to review each type of equipment on an 

annual basis.

6.3.5.2. Environmental Control Review

The purpose of these audits is to ensure the laboratory procedures pertaining 

to the laboratory environment are performed as prescribed. The processes 

audited may include, but are not limited to:
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Office of Regulatory Science

Document Number:

MAN-000033

Revision #: 04

Revised:

07 Oct 2022

Title: 

ORA Lab Manual Vol. II - Audits (ORA-LAB.4.14) Page 7 of 13

For the most current and official copy, check QMiS.

A. Engineering Controls (Chemical Fume Hoods, Biosafety Cabinets, 

Laminar Flow Hoods, etc.)

B. Water purification systems

C. Environmental monitoring

D. Access control

E. Sample and chemical storage conditions

The recommended frequency is at least once per year or more frequent based 

on management assessments.

6.3.5.3. Standards, Reagents, Media, Reference Standards/Materials 

The purpose of this audit is to ensure appropriate records are available for 

standards, reagents, media, and physical reference standards/materials and 

that related procedures are being followed.

The recommended frequency is at least once per year or more frequent based 

on management assessments.

6.4. Internal Audit (Follow-up/Focused)

Follow-up or focused audits are based upon need. They may be in response 

to prior audits, detected nonconformances, complaints, or as effectiveness 

reviews for planned or completed corrective or preventive actions. These 

audits can be conducted without scheduling or prior notification.

6.5. Training Requirements

Audits shall be carried out by trained and qualified personnel who are, when 

resources permit, independent of the activity audited. Personnel conducting 

audits are trained and qualified based upon completion of one or more of the 

following criteria:

A. previous demonstration of performing audits (e.g., FDA inspections, 

ORA audits).

B. documented training conducted by laboratory QSM.

C. successful completion of a recognized auditing course or auditor 

certification.

6.6. External – Second Party Audits

Audit performed by personnel not from the local laboratory. For example, this 

might be an audit performed by another ORS laboratory quality system 

manager, other ORS personnel, etc.
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Office of Regulatory Science

Document Number:

MAN-000033

Revision #: 04

Revised:

07 Oct 2022

Title: 

ORA Lab Manual Vol. II - Audits (ORA-LAB.4.14) Page 8 of 13

For the most current and official copy, check QMiS.

If an external auditor or a team is utilized, the auditor or audit team may hold 

opening and closing meetings with management to outline the plan of action 

and discuss findings and whether the laboratory conforms to stated 

requirements.

6.7. External – Third Party Audits

Performed by accreditation organization auditors. All audit findings resulting 

from a third-party audit must be addressed using the corrective action process, 

including root cause analysis.

6.8. Nonconformances

Nonconformances may be corrected on the spot if the issue is minor, isolated, 

and can be easily corrected. These nonconformances are recorded in the final 

report with corrections noted.

Nonconformances that are not corrected “on-the-spot” shall be addressed 

using the Corrective Action procedure. (MAN-000030)

Glossary/Definitions

A. Audit – An audit is a planned and documented investigative evaluation 

of an item or process to determine the adequacy of and compliance with 

planned arrangements and whether these arrangements are 

implemented effectively and are doable to achieve objectives.

B. Audit report – An Audit Report is a summary of the audit scope and 

findings.

C. Quality factors – These criteria are quality elements needed for 

purposeful work. Work requests or compliance programs directing a 

piece of work or general guidance documents, such as the Laboratory 

Manual, the Quality Management System Manual, pertinent laboratory 

procedures and work instructions, contain quality elements.

D. Horizontal Audit – Examination of an element of the management 

system across multiple samples, people, equipment, departments, etc.

E. Monitor – To monitor is to observe and record activity to measure 

compliance with a standard of performance, routine, and ongoing 

collection of data about the indicator.
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Office of Regulatory Science

Document Number:

MAN-000033

Revision #: 04

Revised:

07 Oct 2022

Title: 

ORA Lab Manual Vol. II - Audits (ORA-LAB.4.14) Page 9 of 13

For the most current and official copy, check QMiS.

F. Non-conformity – A non-conformity is non-fulfillment of a specified or 

implied requirement of the quality management system or of a quality 

work product.

G. Objective evidence – Objective evidence is information, which can be 

proven true, based on facts obtained through observation, 

measurement, test, or other means. Objective evidence includes, but is 

not limited to staff interviews, direct observation, document review, or 

record review.

H. Observation – An observation is objective evidence that creates 

concern that may indicate future problems. Often these areas noted can 

be the basis for an Improvement action.

I. On-the-spot correction - This is an immediate step taken to correct or 

resolve a non-conformity.

J. Performance audit – a performance audit is an assessment of the 

technical activities of personnel and are categorized as a quantitative 

appraisal of quality.

K. Requirement – A requirement is a declared, implied, or routine need or 

expectation.

L. System audit – A system audit is an on-site assessment of the 

laboratory’s quality management system and referred to as a qualitative 

appraisal of quality. 

M. Vertical Audit – Examination of one sample through all aspects of 

handling.

Records

A. Completed audit checklists

B. Process forms in QMiS

• Lab Onsite Review Check List

• Lab Sample Accountability Quality Factor Checklist

• Lab Environmental Quality Factor Checklist

• Lab Equipment Quality Factor Checklist

• Lab Standards_Reagent_Media Quality Factor Checklist

• Lab Worksheet Review Quality Factor Checklist

C. Audit Report in QMiS
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Office of Regulatory Science

Document Number:

MAN-000033

Revision #: 04

Revised:

07 Oct 2022

Title: 

ORA Lab Manual Vol. II - Audits (ORA-LAB.4.14) Page 10 of 13

For the most current and official copy, check QMiS.

D. Corrective Action records in QMiS

Supporting Documents

A. MAN-000030 ORA Lab Manual Vol. II - Corrective Action (ORALAB.4.11)

B. WI-000238 How to Access and Complete the Laboratory Worksheet 

Review Quality Factor Checklist

C. JA-000230 Using the QMiS Worksheet Review Quality Factor Checklist 

(QFC) Process Form

Document History

Revision

#

Status*

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

and Title

1.4 R 12/31/07 LMEB LMEB

1.5 R 02/06/12 LMEB LMEB

02 R 06/06/2019 LMEB LMEB

03 R 01/23/2020 LMEB LMEB

04 RREFER TO 

QMIS

LMEB LMEB

* - D: Draft, I: Initial, R: Revision
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Office of Regulatory Science

Document Number:

MAN-000033

Revision #: 04

Revised:

07 Oct 2022

Title: 

ORA Lab Manual Vol. II - Audits (ORA-LAB.4.14) Page 11 of 13

For the most current and official copy, check QMiS.

Change History

Revision 

#

Change

02

Removed EAL-G3 reference because it was not mentioned in the rest of the 

document. Removed ORA-QMS references so that this document can stand alone. 

Revised example schedules. Other revisions made as needed to align this procedure 

with new ISO/IEC 17025 and AOAC requirements. Revision to formatting and policy 

clarifications were also made.

03

Revised “Responsibility” section as requested by ORS Management:

• Laboratory Management: Added “May assign auditors within the laboratory for 

internal audits”

• QSM: Changed “Serves as Lead Auditor within the laboratory” to “May serve 

as the lead auditor within the laboratory”

04

Formatting and minor language revisions made. Revised Responsibility section to further 

clarify roles. Added QMiS QFC process forms to Records Section. Updated References and 

Supporting Documents Sections. Section 7 Glossary: Clarified “Observation” can lead to 

Improvement Action. Other minor changes are highlighted throughout the document.

Attachments

List of Attachments

Attachment A - Example of how an audit schedule can be set up ..............................12

Attachment B - Example of an audit schedule organized by ISO/IEC 17025:2017 

elements broken up across a fiscal year .............................................13
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Office of Regulatory Science

Document Number:

MAN-000033

Revision #: 04

Revised:

07 Oct 2022

Title: 

ORA Lab Manual Vol. II - Audits (ORA-LAB.4.14) Page 12 of 13

For the most current and official copy, check QMiS.

Attachment A - Example of how an audit schedule can be set up

The required amount columns are suggestions, not requirements. The 

requirement shall be set by the laboratory.

Review Activity Reviewer Frequency

Worksheet Review Name

Annual - 2 per analyst

Quarterly – 9 Class 1 and 2 each

Quarterly- 7 Class 3

On-Site Review Name Annual – 1 per analyst

Annual – 1 per method

Oral Review Name # Per year

Every 4 years – 1 per analyst

Sample Accountability Name

Quarterly – Random FACTS records, 5 

active, 5 in process or unassigned; 5 

completed.

Equipment Records Name

Quarterly – 5 types each; equipment, 

measurement device, analytical 

instrument

Environmental Controls Name Quarterly - Defined %

Standards, Reagents, Media, 

Physical Reference 

Standards/Materials

Name Quarterly – Defined %

Internal Audit 

(Comprehensive) Name Annual
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Office of Regulatory Science

Document Number:

MAN-000033

Revision #: 04

Revised:

07 Oct 2022

Title: 

ORA Lab Manual Vol. II - Audits (ORA-LAB.4.14) Page 13 of 13

For the most current and official copy, check QMiS.

Attachment B - Example of an audit schedule organized by ISO/IEC 17025:2017 

elements broken up across a fiscal year

ISO/IEC 

17025:2017 & 

AOAC

Requirements

OCT NOV DEC JAN FEB MAR APR MAY JUN JUL AUG SEP

4.1 – 4.2

5.1 – 5.7

8.8 – 8.9

6.1 – 6.2

6.3 – 6.4

6.5 – 6.6

7.1 – 7.3

7.4 – 7.7

7.8 – 7.11

8.1 – 8.4

8.5 – 8.7

COMPLETED