Document control procedure
SOP template
Check this template against your local regulations and your own policies before you use it.
| SOP no. | Version | Effective date | |||
|---|---|---|---|---|---|
| Owner | Approver | Review date |
Purpose
To make sure every controlled document is approved before use, that staff can always find the current version, and that out-of-date copies are withdrawn so nobody follows them by mistake.
Scope
Policies, procedures, work instructions, forms, checklists and templates that tell staff how to work. It doesn't cover records, the completed forms and logs that show work was done; those follow the record keeping and retention procedure.
Responsibilities
| Role | Responsibility |
|---|---|
| Document owner | Writes or updates the document, keeps it accurate, and reviews it on its review date. |
| Approver | Checks the document is correct and workable, and approves it before it's published. |
| Document controller (often the operations or quality manager) | Keeps the document register, publishes approved versions and withdraws old ones. |
| All staff | Use only the published version, and tell the owner when a document is wrong or out of date. |
Definitions
- Controlled document
- A document that tells people how to work, kept in one place with an owner, a version and a review date.
- Uncontrolled copy
- A printout or download, which may be out of date. Printed copies should say so in the footer.
What you need
- The document register or library (one place where the live versions are kept)
- The SOP and policy templates
Procedure
Give the document an owner and a number
Before drafting, agree who owns it and give it a title and number, or a clear name, that it keeps through every version.
Draft it from the template
Use the policy or SOP template so every document has the same parts, including the owner, approver, version and review date.
Review and approve it
Have the people who do the work check the draft, then send it to the approver. Record who approved it and when.
Caution: A document that affects safety, privacy, money or a legal duty needs a manager's approval, not just the owner's.
Publish one live copy
Put the approved version in the document library, update the register, and tell the people affected what's changed.
- Set the version number and the effective date
- Record the change in the revision history
- Train people on the change where it alters how they work
Withdraw the old version
Remove the previous version from the library, shared drives and noticeboards, and collect printed copies. Keep one archived copy marked superseded.
Review on schedule
Review each document by its review date, usually every one to two years, and sooner after an incident, audit finding or change in the law.
Make changes the same way
Any change, however small, goes through steps 3 to 5 and gets a new version number.
Retire documents no longer needed
When a process stops, mark the document retired in the register, remove it from use and archive it for as long as your retention rules say.
Records
- The document register, with each document's number, owner, version, approval date and review date.
- Archived superseded versions, with the dates they were in use.
- Approval records and revision histories.
Related documents
- Record keeping and retention procedure
- Policy template
- SOP template
Revision history
| Version | Date | What changed | Approved by |
|---|---|---|---|
