A food safety plan is the written plan, required by FDA's preventive controls rule for human food, that sets out what could make your food unsafe and what you do to stop it. It has seven parts: a hazard analysis, the preventive controls, a supply-chain program, a recall plan, and the procedures for monitoring, corrective action and verification. It has to be prepared, or overseen, by a preventive controls qualified individual. Facilities registered with FDA need one, unless they're a qualified facility, which most often means a very small business with under about $1 million a year in food sales; they file attestations instead. Below is who needs one, the seven parts, an example for one product, and the records that show it works.
The short version
- A food safety plan is required by FDA's preventive controls rule for registered food facilities.
- Qualified facilities, usually very small businesses, file attestations instead of a full plan.
- Seven parts: hazard analysis, preventive controls, supply-chain program, recall plan, monitoring, corrective actions, verification.
- It's prepared or overseen by a preventive controls qualified individual (PCQI).
- The plan is a record, and so are the logs that show you follow it.
- Many buyers ask for a food safety plan even when FDA doesn't.
- TaroStack keeps the records a plan relies on. It doesn't write the plan. More below.
Who needs one
If your facility registers with FDA, the preventive controls rule applies. Its full requirements, including the food safety plan, don't apply to a qualified facility (21 CFR 117.5). A qualified facility is, most often, a very small business: one averaging under $1 million a year, adjusted for inflation, over three years in sales of human food plus food held without sale (21 CFR 117.3). Retail food establishments and farms generally don't register at all. The whole picture for small businesses is in FSMA requirements for small food businesses.
Even without a legal requirement, a written plan is often what a grocery buyer, a distributor or an auditor asks for, covered in requirements for selling food to grocery stores. This is general information, not legal advice.
The seven parts
A food safety plan must include (21 CFR 117.126):
| Part | What it is |
|---|---|
| 1. Hazard analysis | The biological, chemical and physical hazards that could occur, and which need a control |
| 2. Preventive controls | What you do about each one: process, allergen, sanitation and supply-chain controls |
| 3. Supply-chain program | How you make sure suppliers control the hazards you rely on them for |
| 4. Recall plan | How you'd find, stop and recover product if you had to |
| 5. Monitoring procedures | How you check each control is working, and how often |
| 6. Corrective action procedures | What you do when a check fails |
| 7. Verification procedures | How you confirm the controls work: reviewing records, calibrating, testing |
It must be prepared, or its preparation overseen, by one or more preventive controls qualified individuals: people qualified by training or experience to do it. The plan itself is a record you keep.
An example, for one product
A short excerpt for Windward Roots' taro chips (Windward Roots is the made-up taro business I use in these examples):
| Hazard | Type | Control | Monitoring | If it fails |
|---|---|---|---|---|
| Metal fragments from the slicer | Physical | Blade and guard inspection before and after each run | Logged each run | Hold the run; inspect the product |
| Sesame from a shared seasoning line | Allergen | Clean-down between seasonings; label check | Checklist each changeover | Hold, relabel or destroy |
| Pathogens in seasoning added after frying | Biological | Seasoning only from approved suppliers, with a certificate of analysis per lot | Checked at receiving | Reject the lot |
| Undercooked chips (texture and moisture) | Quality and safety | Oil temperature and fry time | Logged each batch | Hold and re-fry or discard |
This isn't a complete plan; it shows how hazards, controls, monitoring and corrective actions fit together. A food safety professional or a PCQI course is the place to build yours. Records of certificates of analysis are in certificate of analysis tracking.
The records that show it works
| Record | Shows |
|---|---|
| Monitoring logs: temperatures, checks, changeovers | The controls were applied |
| Corrective action records | What happened when a check failed |
| Verification: record reviews, calibrations | Someone checked the checks |
| Receiving records with supplier lots | The supply-chain program is followed |
| Batch records with ingredient lots | Traceability for a recall |
| Recall drills | The recall plan works |
The plan says what you'll do; the records prove you did it. How long to keep them, and the forms, are in how long should HACCP records be kept.
Where this stops working
A food safety plan written once and filed in a binder is common, and it's the logs that fall apart: a temperature not written down on a busy day, a failed check fixed but not recorded, a receiving log with no supplier lots, and no way to show a buyer that a recall would work. An auditor reads the logs, not the plan.
How TaroStack does it
TaroStack keeps the records a food safety plan relies on, as a side effect of running the kitchen. It doesn't write your plan or make anybody compliant; it keeps the records those programs ask for.
Monitoring and corrective action on the batch record. Batch record forms are filled in when the batch is recorded, with your own fields: oil temperature, fry time, changeover checks, initials and sign-off. Number fields carry limits, so a reading outside its limit is recorded and flagged, and the flag is marked reviewed with what was done about it, which is the corrective action record. A batch waiting on a decision can sit on hold.
Receiving and traceability. Deliveries are received as lots, with the supplier's lot code and dates, and a delivery can go straight into quarantine until it's checked. Each batch notes which lots it used, automatically.
A recall plan you can prove. One report walks any lot to the batches it went into, the customers who got them and what's still on your shelves, with contact details, and timed, logged traceability drills show a buyer or an inspector that it works.
| Plan part | On paper | In TaroStack |
|---|---|---|
| Monitoring | Logs on a clipboard | Fields on the batch record |
| Corrective action | A note, sometimes | A flag, reviewed with what was done |
| Supply chain | Receiving log | Lots received, quarantine until checked |
| Recall plan | A document | One report and timed drills |
Lots, receiving, holds, recalls and traceability drills are on every plan, from $49 a month; batch records with limits are on Standard at $99. The first 30 days are free, with no credit card. If you'd like a hand setting up, ask, and we'll do it with you.