Food Plant GMP Audit Checklist, 21 CFR 117

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17 critical items still open - these are the highest-risk gaps.

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Personnel and hygiene

Employees with illness or open wounds are excluded from direct food contactCRITICALHands are washed and sanitized on entry, after breaks and after handling wasteCRITICALHair, beard and clothing are covered or restrained as requiredJewelry and personal items are not worn or carried in production areasGloves, where used, are intact and changed on a defined scheduleEating, drinking and tobacco use are limited to designated areasTraining records exist for food hygiene and food safety, including supervisors

Plant, grounds and facility

Grounds are free of standing water, litter and harborage for pestsFloors, walls and ceilings are cleanable and in good repairDrains function and are cleaned; there is no backflow into product areasCRITICALLighting is adequate and fixtures over exposed food are shieldedVentilation controls condensation and airborne contaminationHandwash stations are supplied with soap, water, towels and signageCRITICALToilet facilities are clean, supplied and do not open directly into productionPest control program is active with trap maps and trend reviewCRITICAL

Equipment and utensils

Food-contact surfaces are corrosion resistant, smooth and cleanableEquipment design allows access for cleaning and inspectionLubricants used near food are food grade and controlledTemperature, pH and other measuring devices are calibrated and in rangeCRITICALCompressed air and gases that contact food are filtered and cleanMetal detectors or other foreign material controls are verified at the defined frequencyCRITICALMaintenance work leaves no debris, tools or fasteners behind; there is a post-repair release

Sanitation and allergen control

Written cleaning procedures define method, chemical, concentration and frequencyCRITICALSanitizer concentration is checked and recorded with test strips or meterCRITICALChemicals are labeled, stored apart from food and only authorized staff use themPre-operational inspection is done and signed before start-upCRITICALAllergen changeover cleaning is verified with a swab or visual releaseCRITICALRework containing allergens is labeled, controlled and used only in compatible productsCRITICALWet cleaning is controlled in dry areas to avoid creating Listeria or Salmonella niches

Processes, controls and warehousing

Incoming raw materials are inspected and held until verifiedCRITICALRaw and ready-to-eat product flows are separated physically or by timeTime and temperature controls are monitored and recordedCRITICALFinished products are labeled with correct ingredients, allergens and lot codeCRITICALStorage areas are clean, orderly and pallets are off the floor and away from wallsStock rotation (FIFO or FEFO) is followed and expired product is segregatedHold and release status is clear for every pallet or lotVehicles are inspected for cleanliness and temperature before loadingCRITICALA recall plan exists and a mock recall was done within the last 12 monthsCRITICAL

Mark each item. Any critical item that is not met needs a documented corrective action before the next production run. Track the percent of items met per area and trend it by audit.

Track findings to closure

Optional review of how audit findings and CAPA can flow into your ERP or quality system.

Optional. The tool and every export work without this. No spam.

How to run the audit

Print the checklist or work through it on a tablet while walking the plant in the order product moves, from receiving to dispatch. For each item mark met, not met or not applicable, and take a photo of every finding. Critical items are those where a failure can lead directly to contamination of food, so any miss should get a documented corrective action and an owner. Export the completed list to PDF or Excel for the audit file.

Audit all shifts over time, not only day shift
Interview operators as well as checking documents
Trend findings by area to see where controls decay

Structure behind the checklist

Subpart B of Part 117 covers personnel, plant and grounds, sanitary operations, sanitary facilities and controls, equipment and utensils, processes and controls, and warehousing and distribution. This checklist groups the same ideas into five audit areas. It is a practical aid, not a copy of the regulation, so always read the current rule and any state or customer requirements that apply to you.

Reading the results

A 95 percent score can still hide a critical failure, so look at critical items first. Then rank open findings by risk: likelihood of hazard reaching food times severity. Closing three drain and handwash issues usually reduces more risk than closing ten housekeeping items. Repeat findings across two audits point to a system problem rather than a one-off lapse.

Common mistakes

Auditing only when the plant is clean, accepting a signed log without checking the actual condition, ignoring contractor and visitor practices, and failing to verify that corrective actions actually closed the gap. A finding that is closed on paper but reappears in the next audit is still open.

Frequently Asked Questions

Which rule covers GMP for food plants in the US?

21 CFR Part 117 Subpart B contains the current good manufacturing practice requirements for human food. Some operations are subject to modified requirements or exemptions, so confirm what applies to your facility.

How often should GMP audits be done?

Many plants do a full internal audit at least quarterly with weekly or daily walk-throughs of key areas. Your food safety plan and your certification scheme may set the minimum frequency.

Is this enough for a GFSI audit?

No. GFSI-benchmarked schemes such as SQF, BRCGS and FSSC 22000 have their own requirements. Use this as a GMP baseline and map findings to the scheme you certify against.

What is a critical item?

An item where non-conformance can lead directly to food contamination or loss of control of a hazard, such as handwash facilities, allergen changeover and calibrated monitoring devices.

Netray can help move audit findings and corrective actions into your ERP or quality system. The checklist is free to use as is.

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