Validation asks whether a preventive control can control the hazard: before the plan starts, or within 90 days of first production when that's needed, a preventive controls qualified individual gathers scientific evidence, or runs a study, showing that the control, done as written, works. Verification asks whether it is working, every day: calibrating the thermometers, testing product or the environment where that fits, and reviewing the records, monitoring and corrective action records within 7 working days. Validation is done once, and again when something changes; verification never stops. Allergen controls, sanitation controls, the recall plan and the supply-chain program don't need validating, but they do need verifying. In the example below, a Colorado granola maker validates its bake step and sets up its verification.
The short version
- Validation: proof, before or soon after you start, that a control can work.
- Verification: ongoing checks that it is working.
- Validate within 90 days of first production when it can't be done before.
- Revalidate when a change could affect the control.
- Review monitoring and corrective action records within 7 working days.
- Allergen, sanitation, recall and supply-chain controls aren't validated, but are verified.
- TaroStack keeps every batch's record by lot. More below.
The difference
| Validation | Verification | |
|---|---|---|
| The question | Can this control work? | Is it working, batch after batch? |
| When | Before the plan starts, or within 90 days of first production; again after a change | All the time, on a written schedule |
| How | Scientific evidence, or a study | Calibration, product or environmental testing, records review |
| Who | A preventive controls qualified individual, or under one | Staff, with records reviewed by or under a qualified individual |
| Which controls | Process controls and others; not allergen, sanitation, recall or supply-chain | All of them |
The controls themselves come from the hazard analysis, in hazard analysis template, and environmental testing in environmental monitoring program template.
The rules
| Rule | Where |
|---|---|
| Validation | By or under a preventive controls qualified individual; before implementing the plan or within 90 days of first production when needed; after changes; scientific evidence or studies (21 CFR 117.160) |
| Not validated | Food allergen controls, sanitation controls, the recall plan and the supply-chain program (117.160(c)) |
| Verification | Calibration, product testing, environmental monitoring, records review, and other activities; written procedures (117.165) |
| Records review | Monitoring and corrective action records within 7 working days; calibration, testing and supplier records within a reasonable time (117.165(a)(4)) |
| Keeping records | At least 2 years after they were prepared (117.315) |
This is general information, not legal advice.
An example: the bake step
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, bakes its granola as a process control for Salmonella in the oats and nuts. Its preventive controls qualified individual set up both sides:
| Side | What they did | How often |
|---|---|---|
| Validation | A lab study with a surrogate organism on the oven, at the slowest belt speed and coolest zone, showing the bake met its target reduction | Once, and again when the oven or recipe changes |
| Monitoring | Oven temperature and belt speed recorded by the operator | Every hour |
| Verification: calibration | Oven thermometers checked against a reference thermometer | Each month |
| Verification: records review | The qualified individual reviews the oven and corrective action records | Within 7 working days |
| Verification: environmental monitoring | Swabs in the cooling and bagging room | Each week |
When the bakery added a second oven, the change brought a new validation study before the oven's first production run. A deviation, a zone that ran 15 degrees cool for 20 minutes, went on a corrective action record, and the bags from that time were held, in hold and release procedure.
Get the checker
Download the verification tracker. One sheet: each record, the date it was made, the date it was reviewed, and its kind; the working days it took and whether it met the 7-day review fill in. It's an ordinary Excel file with no macros, and it works in Google Sheets, LibreOffice and Numbers.
Where this stops working
The tracker checks the review clock. The oven records only mean something if each one can be tied to the lots baked during it, and the bags those lots filled.
How TaroStack does it
TaroStack keeps every batch by lot and date, so a deviation on the oven log leads to the bags it touched.
Batches by lot and date. Each bake is a batch with its date, the ingredient lots it used and how many bags it made.
Holds by lot. A lot can be put on hold so it can't be sold until it's released.
Recalls. If a lot has to come back, one report shows every customer who got it.
| The job | Notebook | In TaroStack |
|---|---|---|
| Bags baked during a deviation | Matched by hand | Batches by date |
| Keeping held bags off orders | A sign on the pallet | A hold on the lot |
| Who got a lot | Invoices | One recall report |
Batches, lots, holds 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.