Once a quarter, perform a random spot check. Pull 10 SOPs from the floor. Compare them to the master copy in QA. If they differ, fire the line manager, not the operator. Culture flows downhill.
| Activity | Frequency | |----------|-----------| | Periodic review of existing SOPs | Every 1–2 years | | Immediate update after process/equipment change | As needed (change control) | | Update after new regulation (e.g., Schedule M revised) | Within 3–6 months | | Training on revised SOP | Before effective date | pharma devils sop upd
The next time a production supervisor asks you to "just update the SOP quickly and initial it later," recognize that you are being asked to summon the . An uncontrolled SOP update is the single fastest way to convert a routine audit into a warning letter. Once a quarter, perform a random spot check