FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Document Number: 

MAN-000026 

Revision #: 03 

Revised: 

11 Jul 2023 

Title: 

ORA Lab Manual Vol. II - Document Control and Management (ORA-LAB.4.3) Page 1 of 9

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 Documents ........................................................................................................ 3

6.1.1. Quality Management Information System (QMiS) ........................................... 3

6.1.2. Document Identification ................................................................................... 4

6.1.3. Document Formatting ...................................................................................... 4

6.1.4. Document Change Request ............................................................................. 4

6.1.5. Archiving .......................................................................................................... 4

6.1.7. Development or Revision ................................................................................. 5

6.1.8. Document Approval: ........................................................................................ 5

6.1.9. Notification ....................................................................................................... 5

6.1.10. Periodic Review ............................................................................................... 6

6.2. External Documents ....................................................................................................... 6

6.3. Document Retention and Archival .................................................................................. 6

6.4. Process Map .................................................................................................................. 7

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

Records .................................................................................................................................... 8

Supporting Documents ............................................................................................................. 8

Document History ..................................................................................................................... 8

Change History ......................................................................................................................... 8

Attachments .............................................................................................................................. 9

Purpose 

To control all documents that form part of the quality management system 

(either internally generated or from external sources). Document control 

assures that quality system documents used by employees are properly 

developed, approved, contain current information, and are located where 

needed. 
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Document Number: 

MAN-000026 

Revision #: 03 

Revised: 

11 Jul 2023 

Title: 

ORA Lab Manual Vol. II - Document Control and Management (ORA-LAB.4.3) Page 2 of 9

For the most current and official copy, check QMiS. 

Quality system documents include, but are not limited to items defined as 

manuals, procedures, work instructions (WIs), test methods, templates, 

policies, regulations, standards, other normative documents, as well as 

drawings, software, and specifications.

Scope 

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

quality assurance program pertaining to their work products and processes. 

Responsibility 

The responsibility section for this procedure is intended to be general to allow 

for the assignment of roles and responsibilities at each laboratory in 

accordance with their specific staffing resources. 

A. Laboratory Management: 

1. Reviews and approves policies and procedures in their area of 

responsibility and verifies the technical accuracy. 

2. Identifies and ensures training needs are met. 

3. Resolves conflict between the reviewer and preparer of the 

procedure. 

4. Ensures resources are provided. 

B. Quality System Manager (QSM): 

1. Ensures document control system is implemented and maintained. 

2. Coordinates reviews and revisions of quality system documents. 

3. Archives superseded or obsolete documents. 

4. Provides notification to impacted users when changes are made to 

local documents. 

C. Staff: 

1. Verifies the official version of the document is used by checking 

QMiS each time the document is used. 

2. Reviews document content for clarity and accuracy to determine 

need for new procedures or modification to procedures. 

3. Initiates Document Change Requests. 
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Document Number: 

MAN-000026 

Revision #: 03 

Revised: 

11 Jul 2023 

Title: 

ORA Lab Manual Vol. II - Document Control and Management (ORA-LAB.4.3) Page 3 of 9

For the most current and official copy, check QMiS. 

Background 

Document Control is a requirement in accredited Quality Systems to ensure 

use and availability of only authorized editions of appropriate documents with 

periodic reviews to guarantee continuing suitability and compliance with 

applicable standard requirements. Documents enable communication of intent 

and consistency of action. 

References 

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

testing and calibration laboratories, Sections 8.2 and 8.3.

B. 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. 

C. SOP-000104 Document Control and Management (ORA-Level) 

D. WI-000061 How to Create and Send A Transmittal Notice (ORA-Level) 

E. WI-000422 DCR Work Instruction for the Initiator and Approver (ORAlevel) 

Procedure 

The laboratories use the Quality Management Information System (QMiS) for 

document control. QMiS allows access and organization of documents; 

collaboration for development, revision, and review; approvals; and archiving 

of old versions. For assistance using QMiS refer to the user manual and help 

features or contact your local QSM. 

All documents issued to personnel in the laboratory as part of the management 

system are reviewed and approved for use by authorized personnel prior to 

use. Authorized editions of appropriate documents are made available at all 

locations where operations essential to the effective function of the laboratory 

are performed. 

6.1. Internal Documents 

6.1.1. Quality Management Information System (QMiS) 

Internal laboratory documents are controlled in QMiS. Internal documents 

include procedures, work instructions, templates, forms, checklists, lists, 

organization charts, multiuser calculation spreadsheets, databases, etc. 
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Document Number: 

MAN-000026 

Revision #: 03 

Revised: 

11 Jul 2023 

Title: 

ORA Lab Manual Vol. II - Document Control and Management (ORA-LAB.4.3) Page 4 of 9

For the most current and official copy, check QMiS. 

In summary, all documents used prior and during the process of reporting data 

or completing quality management processes must be controlled. 

The QMiS document InfoCard uniquely identifies the document number and 

includes the current revision number, issue date, title, and approval. 

Laboratory staff can only access current revisions of the documents in QMiS. 

Organizers and current document lists are maintained to ensure access to 

required documents at the point of use. 

Documents printed from QMiS are Uncontrolled Documents and are 

automatically identified as uncontrolled. 

6.1.2. Document Identification 

Documents are uniquely numbered according to ORA policy and numbers are 

assigned by QMiS. Drafts outside QMiS, if used, are identified as DRAFT. 

6.1.3. Document Formatting 

Documents are formatted according to ORA policy/guidance for each of the 

document types. 

Documents have a header indicating the document’s unique identifier, date of 

issue and/or revision, page numbering, the total number of pages. 

6.1.4. Document Change Request 

A. The Document Change Request (DCR) form, in QMiS, is used to initiate 

and facilitate document change requests for creation of new documents 

or revisions to approved published document. Refer to WI-000422 DCR 

Work Instruction for the Initiator and Approver. 

B. The standard approval routing for the DCR form goes from the Initiator 

to the Initiator’s Supervisor and/or owner of the process affected by the 

document, and finally to the QSM. 

6.1.5. Archiving 

QSM archives documents in QMiS. Electronic copies in QMiS are “Archived,” 

removed from open access, and retained in the system. Physical copies are 

removed from distributed locations. 

Notification is required to affected users when a document is archived and no 

longer available. 

6.1.6. Document Review: 

A. The assigned reviewer examines the document for adequacy within the 

scope of their expertise. The reviewer uses reference documents and 

other pertinent information upon which to base their review. 
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Document Number: 

MAN-000026 

Revision #: 03 

Revised: 

11 Jul 2023 

Title: 

ORA Lab Manual Vol. II - Document Control and Management (ORA-LAB.4.3) Page 5 of 9

For the most current and official copy, check QMiS. 

B. The reviewer evaluates the document for technical accuracy; conflict 

with policies or procedures in other areas of the laboratory or ORS and 

ORA programs; if known, training needs, additional resources, and any 

impact to customers. Concerns and changes are noted, discussed, and 

reconciled with authors or other subject matter experts (SMEs). 

C. The QSM reviews the document to ensure the requirements of the 

Quality Management System are met. 

6.1.7. Development or Revision 

A. Amendments or changes to documents by hand are not permitted. 

B. New documents or changes to existing documents will be requested 

with a DCR in accordance with section 6.1.4. 

C. QSMs will initiate and coordinate a collaboration task within QMiS for 

approved DCRs. 

D. Authors, reviewers, and approvers are identified by laboratory 

management. 

E. Documents should be drafted at the user level by staff familiar with the 

topic or process. 

F. Document changes are indicated in the change history section of the 

document. 

G. Minor changes may be made, reviewed, and approved by the QSM. 

6.1.8. Document Approval: 

A. Documents are approved by designated managers for adequacy prior to 

issue. 

B. The approver reviews the document for accuracy and fitness for use. 

The approver uses reference documents and other pertinent information 

upon which to base their approval. 

C. The approver ensures it does not conflict with other procedures. 

D. The approver identifies need for training and resources. 

E. Approvers sign off on the document indicating their review and 

approval. 

F. Once sign offs are obtained, the document is issued by the QSM. 

6.1.9. Notification 

A. Notification of new, revised, or archived documents are provided to 

affected personnel, according to ORA policy/procedures. 
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Document Number: 

MAN-000026 

Revision #: 03 

Revised: 

11 Jul 2023 

Title: 

ORA Lab Manual Vol. II - Document Control and Management (ORA-LAB.4.3) Page 6 of 9

For the most current and official copy, check QMiS. 

B. New or revised documents are not used until approved and issued. 

6.1.10. Periodic Review 

A. Documents are reviewed periodically at a minimum of every two years, 

more frequently as determined by the laboratory, or as determined by 

ORA policy according to document type. 

B. The assigned reviewer ensures the continued accuracy and fitness for 

use of the document. 

6.2. External Documents 

Documents from external sources are tracked using controlled lists to ensure 

they are available and current. External documents may include testing kit 

instructions, instrument manuals, instrument software, journal articles, 

laboratory information bulletins, standards, accreditation body resources, etc. 

These lists include the source of the document (when available), and, if 

relevant, page numbers (i.e. a method outlined in a scientific journal). The lists 

are reviewed and updated periodically. Revisions made to external documents 

are reviewed and incorporated into internal documents accordingly. 

6.3. Document Retention and Archival 

A. Documents are retained and archived according to the procedures, 

MAN-000032 ORA-LAB.4.13, Record and Data Management.

B. The QMiS system retains drafts, current, and archived documents 

created and issued in the system. 
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Document Number: 

MAN-000026 

Revision #: 03 

Revised: 

11 Jul 2023 

Title: 

ORA Lab Manual Vol. II - Document Control and Management (ORA-LAB.4.3) Page 7 of 9

For the most current and official copy, check QMiS. 

6.4. Process Map 

Draft

Review

Publish

Approve

Repeat as needed

Notify

Implement

Revise

Collaborate

Theoretically Happen 

Simultaneously

Archive

Notify

Remove from 

Locations

Theoretically Happen 

Simultaneously

Periodic Review

Or

Change Request

Archive Request

New Request

Train

Glossary/Definitions 

A. Document control - Document control ensures “cradle-to-grave” 

management of documents in the management system and that 

documents are reviewed for adequacy, approved for release by 

authorized personnel and distributed to and used at the location where 

the prescribed activity is performed. And when obsolete, are either 

revised or removed from use. 

B. Controlled copy - A controlled copy is an authorized copy of the latest, 

correct issue of a document; an identified issue of a document to an 

individual or location of record. The controlled copy is officially tracked, 

updated, or removed to assure that users have access to only current 

revisions. 

C. Uncontrolled copy - An informal copy of a document for which no 

attempt is made to update it after distribution; the document is marked 

“Uncontrolled” and the user is responsible for determining if the 

document is active prior to use. 

D. Minor changes- Those changes that do not affect the content of quality 

of the action being prescribed in the document, such as typographical or 
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Document Number: 

MAN-000026 

Revision #: 03 

Revised: 

11 Jul 2023 

Title: 

ORA Lab Manual Vol. II - Document Control and Management (ORA-LAB.4.3) Page 8 of 9

For the most current and official copy, check QMiS. 

grammatical changes, formatting or small changes within the document 

that will not invalidate or negate previously issued content. 

Records 

A. Master lists 

B. Document change requests 

C. Transmittal Notices 

D. Current and archived QMiS files and metadata 

Supporting Documents 

A. MAN-000032 ORA-LAB.4.13, Record and Data Management. 

Document History 

Revision 

# 

Status* 

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

1.3 R 11/16/05 LMEB LMEB 

1.4 R 06/06/08 LMEB LMEB 

1.5 R 02/02/10 LMEB LMEB 

1.6 R 02/06/12 LMEB LMEB 

1.7 R 01/22/13 LMEB LMEB 

02 R 05/15/2019 LMEB LMEB 

03 R 

Refer to 

QMiS 

InfoCard 

LMEB LMEB 

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

Change History 

Revision 

# Change 

1.3 In document. 

1.4 In document. 

1.5 In document. 

1.6 In document. 

1.7 In document. 
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Document Number: 

MAN-000026 

Revision #: 03 

Revised: 

11 Jul 2023 

Title: 

ORA Lab Manual Vol. II - Document Control and Management (ORA-LAB.4.3) Page 9 of 9

For the most current and official copy, check QMiS. 

Revision 

# Change 

02 Changed 1st – 3rd level Manager responsibilities to “Laboratory Management”; added 

Background & References information; referred to OQMS-level document for formatting 

instructions; specified use of QMiS DCR; Development & review process streamlined; 2-

year review added; added requirements/inclusions for external master list; updated 

process chart. 

Other revisions made to align this procedure with new ISO/IEC 17025 and AOAC 

requirements. Revision to formatting and policy clarifications were made. 

03 Removed requirement for DCR to archive documents. Added requirement of notification for 

archived documents. Added clarification of types of documents that require control. 

Attachments 

NONE