# Food Plant GMP Internal Audit Checklist Based on 21 CFR 117 Subpart B > Source: https://netray.co/tools/food-plant-gmp-internal-audit-checklist > Publisher: Netray (netray.co), AI and integration engineering for ERP and manufacturing systems. > Section: Free Tools ## Short answer Walk-through GMP checklist for food plants covering personnel, premises, equipment, sanitation, processes and storage. ## Category quality ## Industry Food and Beverage Manufacturing ## Region United States ## Audience - Food safety manager - QA auditor - Plant manager ## Tool **Kind:** checklist **Scoring Note:** 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. **Groups:** #### Personnel and hygiene **Items:** **Text:** Employees with illness or open wounds are excluded from direct food contact **Critical:** true **Text:** Hands are washed and sanitized on entry, after breaks and after handling waste **Critical:** true Hair, beard and clothing are covered or restrained as required Jewelry and personal items are not worn or carried in production areas Gloves, where used, are intact and changed on a defined schedule Eating, drinking and tobacco use are limited to designated areas Training records exist for food hygiene and food safety, including supervisors #### Plant, grounds and facility **Items:** Grounds are free of standing water, litter and harborage for pests Floors, walls and ceilings are cleanable and in good repair **Text:** Drains function and are cleaned; there is no backflow into product areas **Critical:** true Lighting is adequate and fixtures over exposed food are shielded Ventilation controls condensation and airborne contamination **Text:** Handwash stations are supplied with soap, water, towels and signage **Critical:** true Toilet facilities are clean, supplied and do not open directly into production **Text:** Pest control program is active with trap maps and trend review **Critical:** true #### Equipment and utensils **Items:** Food-contact surfaces are corrosion resistant, smooth and cleanable Equipment design allows access for cleaning and inspection Lubricants used near food are food grade and controlled **Text:** Temperature, pH and other measuring devices are calibrated and in range **Critical:** true Compressed air and gases that contact food are filtered and clean **Text:** Metal detectors or other foreign material controls are verified at the defined frequency **Critical:** true Maintenance work leaves no debris, tools or fasteners behind; there is a post-repair release #### Sanitation and allergen control **Items:** **Text:** Written cleaning procedures define method, chemical, concentration and frequency **Critical:** true **Text:** Sanitizer concentration is checked and recorded with test strips or meter **Critical:** true Chemicals are labeled, stored apart from food and only authorized staff use them **Text:** Pre-operational inspection is done and signed before start-up **Critical:** true **Text:** Allergen changeover cleaning is verified with a swab or visual release **Critical:** true **Text:** Rework containing allergens is labeled, controlled and used only in compatible products **Critical:** true Wet cleaning is controlled in dry areas to avoid creating Listeria or Salmonella niches #### Processes, controls and warehousing **Items:** **Text:** Incoming raw materials are inspected and held until verified **Critical:** true Raw and ready-to-eat product flows are separated physically or by time **Text:** Time and temperature controls are monitored and recorded **Critical:** true **Text:** Finished products are labeled with correct ingredients, allergens and lot code **Critical:** true Storage areas are clean, orderly and pallets are off the floor and away from walls Stock rotation (FIFO or FEFO) is followed and expired product is segregated Hold and release status is clear for every pallet or lot **Text:** Vehicles are inspected for cleanliness and temperature before loading **Critical:** true **Text:** A recall plan exists and a mock recall was done within the last 12 months **Critical:** true ## Content **Intro:** Current Good Manufacturing Practice is the base layer under every food safety plan. This checklist follows the structure of 21 CFR Part 117 Subpart B so an internal auditor can walk the plant and mark findings area by area. **Sections:** #### How to run the audit **Body:** 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. **Bullets:** - 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 **Body:** 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 **Body:** 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 **Body:** 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. **Cta:** Netray can help move audit findings and corrective actions into your ERP or quality system. The checklist is free to use as is. **Faq:** #### Which rule covers GMP for food plants in the US? **Answer:** 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? **Answer:** 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? **Answer:** 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? **Answer:** 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. ## Search terms GMP audit checklist food, 21 CFR 117 checklist, food plant internal audit, cGMP food manufacturing checklist, FDA inspection preparation food plant, good manufacturing practice food template, GMP inspection form, food facility audit checklist --- Talk to an engineer: https://netray.co/contact?intent=erp_ai | Machine catalog: https://netray.co/agent/catalog.json