Food Safety Plan Development and Records
Domain 6 covers building and maintaining the food safety plan (117.126) and its records (117.165, 117.170). Questions turn on who signs, what is retained, and for how long.
Plan requirements
- A written plan prepared, or overseen, by a PCQI.
- Contents: the written hazard analysis; preventive controls with parameters and values, monitoring, corrections, and verification; a recall plan whenever a hazard requiring a preventive control exists; a supply-chain program where applicable.
- The plan is signed and dated by the owner, operator, or agent in charge upon initial development and whenever it is modified. The PCQI prepares or oversees; the signature duty belongs to the person in charge.
- The plan must be made available to FDA on request, and records must be retrievable promptly; offsite storage is acceptable only if retrieval is timely.
- Records must be accurate, legible, and kept as originals or true copies for at least 2 years.
Keeping the plan current
Reanalysis is required when a significant change creates a new hazard or a significant increase in an existing hazard, and when a preventive control is found ineffective, with completion within 90 calendar days of the trigger. Every modification must be documented in the plan and followed by a new signature and date.
Worked example
A plant adds a sesame-containing dressing on line 3. The PCQI reanalyzes: a new allergen hazard appears on shared equipment, so an allergen control is added - sequencing, verified changeover, label check. The plan is updated and signed and dated by the plant manager. Operators are retrained on the changeover, and the training record is filed with the revised hazard analysis. Had the change lived only in a production SOP and never in the plan, the facility could not show the plan reflects current operations - a routine inspection finding.
Traps
- Retaining records for 12 months instead of 2 years.
- Leaving the plan unsigned, or unrevised after a process or product change.
- Treating "PCQI" as a job title rather than documented training at least equivalent to the standardized curriculum, or qualifying job experience.
- Storing records offsite with no retrieval process.
- Filing corrective actions in a log that never feeds the verification review.