Implementation of an FSMS Based on ISO 22000
This domain tests clause 8 in practice: can you put PRPs, traceability, hazard controls and nonconformity handling into daily operation?
Operating the system
- PRPs (8.2): hygiene, pest control, maintenance, supplier approval, allergen control, calibration and personnel health, each with defined criteria and monitoring.
- Traceability (8.3): lot identification of raw materials, packaging, intermediates and finished product, plus a tested traceability system with a defined time frame, ideally supported by mass balance.
- Emergency preparedness (8.4): scenarios such as fire, flood, utility loss or malicious contamination, with a tested response.
- Hazard control plan (8.5.4): each CCP and OPRP with its limits or action criteria, monitoring method, frequency, responsible person, record, and the reaction to deviation.
- Nonconformity (8.9): corrections, corrective actions, handling of potentially unsafe product, and withdrawal/recall (8.9.5) with a documented, tested procedure.
Worked example
A pasteuriser is a CCP at 72 °C for 15 s with continuous recording and flow diversion on deviation. During a shift the outlet temperature drops to 69 °C for four minutes. The correction is diversion and holding the affected product. The corrective action is investigating the cause (fouled plates), reviewing other batches, retraining and checking the plate-inspection PRP. Verification confirms the recorder is calibrated and the diversion valve works. The reasoning: the standard separates regaining control from eliminating the cause.
Traps
Monitoring without a defined reaction plan; traceability tested only on paper without quantities; corrective action recorded as "operator reminded"; no validation when a new process or ingredient is introduced; withdrawal plans that have never been exercised.