A hazard analysis is the first part of a food safety plan under FDA's preventive controls rule, and it has to be written whatever it finds. For each type of food, list the known or reasonably foreseeable hazards: biological, such as pathogens and environmental pathogens; chemical, including allergens, pesticide residues, natural toxins and unapproved additives; and physical, such as metal, glass and stones. Consider hazards that occur naturally, that get in by accident, and that someone might add for economic gain. Then evaluate each one: how severe the illness or injury would be, and how likely it is without a control. The hazards that come out as needing a preventive control are what the rest of the plan is built around: process controls, allergen controls, sanitation controls, supply-chain controls and a recall plan. A preventive controls qualified individual prepares or oversees it. In the example below, a Colorado granola maker writes its first one.
The short version
- The hazard analysis is written, whatever it finds.
- List biological, chemical and physical hazards, including allergens.
- Include hazards added for economic gain.
- Evaluate each for severity and likelihood without a control.
- Exposed ready-to-eat food: evaluate environmental pathogens.
- Hazards needing a preventive control become the plan's controls.
- TaroStack keeps the batch, lot and supplier records the plan relies on. More below.
The template
| Column | What goes in it |
|---|---|
| Ingredient or step | Each raw material, then each step: receiving, mixing, baking, cooling, adding inclusions, bagging, storing |
| Hazard | Biological, chemical or physical, by name |
| Why it might occur | Naturally, by accident, or added for economic gain |
| Severity and likelihood | How serious if it occurs; how likely without a control |
| Needs a preventive control? | Yes or no, and why |
| The control | Process, allergen, sanitation or supply-chain control, or the recall plan |
A qualified facility doesn't have to write one, though many do; whether you are one is in qualified facility attestation. Who prepares the plan is in pcqi requirements.
The rules
| Rule | Where |
|---|---|
| The hazard analysis | Written regardless of outcome; biological, chemical and physical hazards, natural, unintentional or for economic gain; severity and probability without controls; environmental pathogens for exposed ready-to-eat food (21 CFR 117.130) |
| Preventive controls | Written, for each hazard needing one: process, food allergen, sanitation and supply-chain controls, a recall plan, and others (117.135) |
| The food safety plan | Prepared or overseen by a preventive controls qualified individual; the hazard analysis, controls, supply-chain program, recall plan and the monitoring, corrective action and verification procedures (117.126) |
| Who it applies to | Registered facilities under subpart C; not qualified facilities (117.5(a)) |
This is general information, not legal advice.
An example: baked granola
Summit Ridge Snacks, a made-up granola and snack bar maker in Boulder, Colorado, with about $2.4 million a year in sales to grocers in six states, wrote its first hazard analysis for its baked almond granola, with almonds and chocolate chips added after baking:
| Ingredient or step | Hazard | Needs a control? | The control |
|---|---|---|---|
| Oats, honey, oil (baked) | Salmonella | Yes | The bake: a process control with a time and temperature |
| Almonds and chocolate chips (added after baking) | Salmonella | Yes | Supply-chain controls: suppliers pasteurize and roast |
| Cooling and bagging, exposed after the bake | Salmonella from the plant | Yes | Sanitation controls; environmental monitoring |
| Almonds, milk in the chocolate, soy lecithin | Undeclared allergens | Yes | Allergen controls: labels checked, runs scheduled |
| Bagging line | Metal fragments | Yes | A metal detector: a process control |
| Honey | Syrup added for economic gain | No | Not a safety hazard here; the supplier is approved |
The bake is validated and checked, in validation vs verification, and the almonds and chocolate come under the supplier program, in supply chain program. The honey line shows a hazard considered and written down even though it needs no control, which the rule asks for.
Get the checker
Download the hazard analysis template. One sheet: each ingredient or step, the hazard, its type and why it might occur, severity and likelihood scores; whether it needs a preventive control fills in, and you write the control. It's an ordinary Excel file with no macros, and it works in Google Sheets, LibreOffice and Numbers.
Where this stops working
The template is the thinking. The plan only works if every bag can be traced back to the lots of almonds and chocolate in it, and the bake records for that day.
How TaroStack does it
TaroStack keeps the supplier, lot and batch records a food safety plan relies on.
Receiving by supplier and lot. Each delivery of almonds and chocolate is received from its supplier with its lot.
Batches by lot. Each bake records the ingredient lots it used and how many bags it made.
Recalls. If a supplier recalls a lot, one report shows which batches used it and every customer who got them.
| The job | Notebook | In TaroStack |
|---|---|---|
| Which almond lot went into a batch | A notebook | Batches by lot |
| Deliveries by supplier | Invoices | Receiving by supplier and lot |
| Who got a recalled lot | Order history | One recall report |
Receiving, batches, lots and recalls are on every plan, from $49 a month. 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.