This is the sheet where you record, area by area, that you checked the cleanliness of food-contact surfaces and the prevention of allergen cross-contact and cross-contamination. Facilities subject to FDA's preventive controls rule need it when their food safety plan identifies sanitation controls (21 CFR 117.135(c)(3)). Like any preventive control, its monitoring must be documented (21 CFR 117.145(c)).
How to use this template
- At the top, write the facility name, its location, the area or line and the period the sheet covers.
- List each piece of equipment, utensil or surface your sanitation procedure says to check.
- At each check, write what you checked, how (for example, visual inspection or a test) and the actual result you observed, with date, time and initials (21 CFR 117.305).
- If something is not acceptable, write the correction you made (for example, re-cleaning) before production continues.
- Hand the sheet in for review: the reviewer signs and dates the verification line (21 CFR 117.165(a)(4)(i)).
What the rule says
- Sanitation controls must include, as appropriate to the facility and the food, procedures for (i) the cleanliness of food-contact surfaces, including utensils and equipment, and (ii) the prevention of allergen cross-contact and cross-contamination from insanitary objects and from personnel to food, food packaging material and other food-contact surfaces, and from raw product to processed product (21 CFR 117.135(c)(3)).
- If you take timely action to correct a condition that is not consistent with those sanitation controls, you do not need to follow the full corrective action procedure; but corrections are documented in records when appropriate (21 CFR 117.150(c)(1) and (d)).
- Outside refrigeration temperature monitoring, exception records may be adequate in some circumstances (21 CFR 117.145(c)(2)(ii)).
- Every Part 117 record must include information to identify the plant or facility (name and, when necessary, location), the date and, when appropriate, the time of the activity, the signature or initials of the person performing it and, where appropriate, the product identity and lot code (21 CFR 117.305(f)).
- The record must contain the actual values and observations obtained during monitoring, be accurate, indelible and legible, and be created concurrently with the activity (21 CFR 117.305(b) through (d)). Write in ink, not pencil, and do not fill it in from memory at the end of the shift.
- Monitoring and corrective action records must be reviewed within 7 working days after they are created, by (or under the oversight of) a preventive controls qualified individual (PCQI), or within a reasonable timeframe if the PCQI prepares a written justification for a longer one (21 CFR 117.165(a)(4)(i)).
- Keep the records at the facility for at least 2 years after the date they were prepared. They may be stored offsite (except the food safety plan) if they can be retrieved and provided onsite within 24 hours of a request for official review; electronic records accessible from an onsite location count as onsite (21 CFR 117.315(a)(1) and (c)).
Official sources
- 21 CFR 117.135 (controles preventivos / preventive controls)
- 21 CFR 117.145 (monitoreo / monitoring)
- 21 CFR 117.150 (acciones correctivas / corrective actions)
- 21 CFR 117.165 (verificación / verification)
- 21 CFR 117.305 (requisitos de los registros / record requirements)
- 21 CFR 117.315 (retención / retention)
Sources verified on November 11, 2026.