Change Control for SOPs: From Change Request to Retraining

1. Request. Anyone who finds a problem or a better way raises a change request that says what should change and why.
2. Assess. The owner decides whether the change is needed, how urgent it is and what else it affects: other SOPs, forms, training or systems.
3. Draft. The author edits a new draft version. The current version stays in force until the new one is approved.
4. Review and approve. A reviewer checks the draft and the approver signs it off, with the outcome recorded.
5. Implement. The new version gets an effective date and replaces the old one wherever staff find SOPs.
6. Retrain. Everyone who follows the SOP confirms the new version. Their earlier confirmations stay attached to the earlier version.

Scale the route to the risk. A typo fix or a new screenshot can take a short path with the owner's approval. A change to what people do, a limit, a check or a responsibility should go through review, approval and retraining. Decide the rule once, write it into the SOP that governs your SOPs, and apply it the same way every time.

A deviation is a one-off departure from an SOP, not a change to it. In drug manufacturing, 21 CFR 211.100(b) requires deviations from written procedures to be recorded and justified. If the same deviation keeps happening, treat it as a signal that the SOP needs a change request.

Tools differ in how much of the route they enforce. Qualio lists change control as a module of its quality system. SweetProcess lets teammates suggest improvements that managers approve, and shows tracked, highlighted changes. Process Street records approve or reject decisions with comments and, since February 2026, can move active workflow runs to the latest workflow version. Capture-first tools keep version history, 14 days on the Pro and Team plans of Haiku and on the Free and Pro plans of Tango, but do not describe an approval step, so the request and approval record may need to live elsewhere.