Deviation
Every food safety system has a plan for when things go right. The deviation procedure is the plan for when they don’t — and it’s the document auditors read first, because it shows what actually happens under pressure.
Definition
A deviation is a failure to meet a critical limit at a CCP — or, more broadly, any departure from a specified requirement. It means the process is no longer in control, and the predetermined response starts now.
Key facts
- At a CCP, deviation = automatic corrective action. The affected product goes on hold, gets evaluated by qualified people, and is released, reworked, or destroyed based on evidence — not optimism.
- “Affected product” means everything since the last good monitoring check. This is why monitoring frequency matters: check hourly, and an hour’s production is at stake; check per shift, and it’s the whole shift.
- The record needs: what happened, when, what product was involved, the disposition decision and its justification, the root cause, and the fix.
- Repeat deviations at the same CCP are a flashing red light — the plan or the process is inadequate, and dispositioning product each time is just expensive denial.
- FDA investigators specifically dig into deviation and corrective-action records. Gaps here draw observations fast.
Why it matters
The deviation log is the most honest document in a food plant. Perfect records with zero deviations usually mean one of two things: a superb process, or monitoring that never looks closely enough. A thick deviation file with solid dispositions is a healthier sign than a suspiciously empty one. Deviations are normal; it’s the response that’s audited.
Sources: Codex Alimentarius; FDA; WHO.
Quick reference
| Step on deviation | Action |
| 1 | Execute predetermined corrective action |
| 2 | Hold all product since last good check |
| 3 | Qualified evaluation: release, rework, or destroy |
| 4 | Root cause + fix the system |
| 5 | Document everything; trend repeats |