The SOP that is approved, issued, and then filed in a binder that nobody opens has not been implemented. Implementation means every person who performs the process has been trained, has confirmed understanding, and is performing the process to the standard.
- Deliver training to all affected personnel — using the SOP or work instruction; demonstration + supervised practice for procedural tasks
- Document training completion — training record for each person; confirming they have been trained to the current version
- Make the document accessible at the point of use — at the workstation, in the quality system, or wherever the person needs to reference it while performing the task
- Confirm implementation — QA or supervisor observes the process being performed to the new standard within 2–4 weeks of training