When to use this article
One change must move multiple SOPs to Ready for Training on the same day, and/or obsolete older effective versions; or a type requires change control before a new draft.
Product/process change control lives in QMS, not this document change control object.
Roles
| Role | Responsibility |
|---|---|
| Change manager | Create control, set implementation date, maintain lists, send for approval |
| Authors | Edit drafts on the release list and submit for review |
| Document reviewers | Review each draft |
| Approver | Confirm the batch — what releases, what obsoletes, implementation date (not content review) |
Create and populate lists
- Create a Document Change Control object.
- Set proposed implementation date and description.
- Release list: add currently effective documents to revise; the system creates or links drafts.
- Obsolescence list: add effective versions to withdraw on the implementation date; they stay Effective until that date.
Documents not on a list can still follow the standalone review path.
Approval and implementation date
- Authors finish drafts → submit → reviewers pass.
- Release-list documents enter Waiting for Change Control Approval when applicable.
- Change manager sends for approval; approver approves or rejects on the workflow task.
- Approval does not change document states; it locks the batch and date.
- On proposed implementation date:
- Release list → Ready for Training
- Obsolescence list → Obsolete (not via Ready for Training)
- Obsolescence list → Obsolete (not via Ready for Training)
Owners still make effective
After Ready for Training, each document owner runs Make Effective. Coordinate within the same window so related main SOPs and child work instructions do not drift.
Training handoff
When documents are Ready for Training or Effective, run Update Training Assignments or Issue Training so the matrix receives new material.
FAQ
| Symptom | What to check |
|---|---|
| Approved but not Ready for Training | Implementation date not reached, or document not on release list |
| Obsolete too early | Obsolescence should fire only on implementation date |
| Two change-control models | Prefer one model per vault; retire single-document CC when moving to multi-document |