- Owner
- Document Controller
- Effective date
- September 15, 2026
- Review cycle
- Every 12 months
1.Purpose
To make sure controlled documents are uniquely numbered, reviewed and approved before use, distributed so only the current revision is accessible, and withdrawn from active use once superseded.
2.Scope
Applies to the lifecycle of controlled documents, including SOPs, work instructions, forms and policies, from numbering through approval, distribution, revision and obsolescence. Writing the actual content and structure of a new SOP is covered by the SOP for Writing SOPs.
Definitions
- Controlled document
- A document whose creation, revision and distribution follow a formal process to keep only the current version in use.
- Document master list
- The register of every controlled document, its current revision and effective date.
- Obsolete document
- A superseded revision that has been withdrawn from active use and archived.
- Effective date
- The date a document revision becomes the official version in use.
3.Responsibilities
- Document Controller
- Numbers, publishes, distributes and archives controlled documents and maintains the master list.
- Document Owner
- Drafts and updates the document content and incorporates review feedback.
- Approver
- Formally approves the document before it is released for use.
- Quality Manager
- Audits work areas and the master list to confirm only current revisions are in use.
RACI matrix
| Activity | Document Controller | Document Owner | Approver | Quality Manager |
|---|---|---|---|---|
| Number and draft the document | R/A | R | I | I |
| Review and approve the document | C | C | R/A | I |
| Publish and update the master list | R/A | I | I | I |
| Withdraw obsolete revisions | R/A | I | - | I |
| Audit work areas for current revisions | C | I | - | R/A |
R = Responsible, A = Accountable, C = Consulted, I = Informed
4.Materials and PPE
Materials, tools and systems
- →Document management system
- →Document master list
- →Document numbering convention
- →Revision history template
5.Procedure
- 5.1
Assign a document number
Document ControllerWhen a new controlled document is requested, the Document Controller assigns a unique document number and title using the numbering convention.
Checkpoint: The assigned number is not already in use anywhere on the master list.
- 5.2
Draft the content
Document OwnerThe Document Owner drafts the document content covering its purpose, scope and required detail.
- 5.3
Route for review
Document ControllerThe Document Controller routes the draft to the relevant technical and quality reviewers and tracks their feedback.
- 5.4
Incorporate review comments
Document OwnerThe Document Owner updates the draft to address reviewer comments and resolves any open questions before resubmitting.
- 5.5
Submit for approval
Document ControllerThe Document Controller submits the finished document for formal approval once review comments are resolved.
- 5.6
Approve the document
ApproverThe Approver reviews the final draft and records their approval with name, date and approval method.
Checkpoint: Approval is recorded with a name and date before the document is released for use.
- 5.7
Assign the effective date
Document ControllerThe Document Controller assigns the effective date and revision number for the newly approved document.
- 5.8
Publish the document
Document ControllerThe Document Controller publishes the approved document to the controlled repository in the document management system.
- 5.9
Update the master list
Document ControllerThe Document Controller updates the master list with the new revision number, effective date and storage location.
- 5.10
Withdraw the previous revision
Document ControllerThe Document Controller withdraws the previous revision from active circulation and archives it, marking it clearly as obsolete.
Warning: An obsolete document left accessible in an active work area can lead someone to follow outdated instructions.
- 5.11
Notify affected teams
Document ControllerThe Document Controller notifies the teams affected by the new or revised document and flags any required training.
- 5.12
Distribute controlled copies
Document ControllerThe Document Controller distributes physical or digital copies with access restricted to the current revision only.
- 5.13
Audit work areas
Quality ManagerThe Quality Manager periodically audits the master list and physical or shared work areas to confirm only current revisions are accessible.
6.Quality checks
- →Every controlled document on the master list has a recorded approval.
- →Obsolete revisions are removed from active work areas.
- →Document numbers on the master list are unique with no duplicates.
- →Periodic audits confirm only current revisions are accessible to staff.
7.Records
- →Document master list
- →Approval record for each revision
- →Obsolete document archive
- →Notification or training record for affected teams
8.KPIs
- →Percentage of documents past their scheduled review date
- →Average time from draft to approval
- →Number of obsolete-document findings during audits
- →Document master list accuracy rate
9.Common mistakes
- →Editing a controlled document without going through review and approval.
- →Leaving an old printed copy in a work area after a revision is released.
- →Issuing a new revision without updating the master list.
- →Skipping the notification step so teams keep using the old version.
10.Revision history
| Revision | Date | Description | Reviewed by |
|---|---|---|---|
| 1.0 | September 15, 2026 | Initial release | Ilia Pirozhenko |
This is a template. Adapt it to your organization, equipment and local regulations before use.
