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Food plant GMP inspection checklist (21 CFR 117 subpart B)

A GMP inspection is a walk through a food plant that checks the conditions every product depends on: people's hygiene, the building and grounds, cleaning and pest control, water and hand washing, equipment, how ingredients and product are handled, and storage. In the US those conditions are set by 21 CFR Part 117, subpart B, the FDA's Current Good Manufacturing Practice rule for human food. This checklist turns subpart B, and the training rule in 117.4, into 55 plain questions, each citing the paragraph it comes from and saying what to look at. The Excel version grades each check OK, Minor, Major, Critical, N/A or Not checked, dates every finding from its grade, flags what is overdue or needs a product hold, and totals the results by section, by grade and by walk stop, with a trend log. The PDF has the checklist, a corrective action log, a nine-stop walk route and a worked example for a bakery. It is a US FDA-oriented self-inspection aid: not legal advice, not an FDA inspection or a GFSI or certification audit, and not a substitute for your food safety plan.

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Page 1 of the food plant GMP inspection checklistPlant, date and inspector fields, the six grades, and the first 11 checks with their 21 CFR 117 paragraph, what to look at, a walk stop, grade circles and space for the finding and owner.
55 checks citing 21 CFR 117What to look at for each checkSix grades with days to fixFinding, owner and due dateCorrective action logResults by section and gradeFindings by walk stopTrend logNine-stop walk routeWorked example (bakery)

When to use it

When to use a food GMP inspection checklist

  • The monthly GMP walk by the QA lead and a production leader, so every part of the plant is checked against the same rule.
  • Before an FDA inspection, a customer audit or a certification audit, to find and fix the gaps first.
  • After a change: a new line, building work, a new pest contractor or cleaning crew, or a run of findings in one area.
  • Teaching new QA technicians and supervisors what the food GMP rule asks for, paragraph by paragraph.

How to fill it in

  1. 1

    Set the days to fix, then pick a walk date

    Agree how fast each grade must be fixed. The sheet's example settings: Critical the same day, after the product is held; Major within 7 days; Minor within 30. Walk when the lines are running.

  2. 2

    Walk the route, clean to dirty

    Start where finished food is exposed and end outside and in the office, so nobody carries dirt from the yard into packing. Walk with two or three people, one from outside the area. Each check has a default stop on the nine-stop route.

  3. 3

    Grade every check where it happens

    OK, Minor, Major or Critical; N/A only when the check cannot apply to your plant; Not checked when you could not see it. Look where the sheet says: up over open product, under conveyors, at the sinks during a break. Ask operators, do not only look.

  4. 4

    Write findings someone can fix

    What, exactly where, a photo number and one owner. "Floor dirty" cannot be fixed; "flour build-up under the line 1 divider frame" can. The due date fills in from the grade.

  5. 5

    Act on a Critical finding before you walk on

    Food, a food-contact surface or packaging contaminated, or about to be: stop the activity, hold the product and tell the person who decides on held product before production goes on.

  6. 6

    Close with evidence and watch the trend

    Close a finding only when someone has checked the fix. Copy the walk's line into the trend log, see which sections and stops keep producing findings, and start the next walk with the open ones. A finding that keeps coming back goes on a corrective action form.

How to grade

The six grades and how fast to fix each one

The grades and the days to fix are example settings this template sets, not FDA's. Change the days in the Excel version to your own rule.

  • OK

    What it means
    In place. Nothing found.
    Fix within (example)
    Nothing to fix

  • Minor

    What it means
    A lapse that does not expose food, food-contact surfaces or packaging right now, such as a worn door seal at the dock.
    Fix within (example)
    30 days

  • Major

    What it means
    Could contaminate food or cause allergen cross-contact if it is left, such as a blocked hand-wash sink. Make it safe the same day.
    Fix within (example)
    7 days

  • Critical

    What it means
    Food, a food-contact surface or packaging is contaminated or about to be: pests on open product, broken glass over exposed food, a chemical in an ingredient bin. Stop and hold the product.
    Fix within (example)
    The same day, before production goes on

  • N/A

    What it means
    Does not apply to this plant, such as outdoor silos at a plant without any. Left out of the score.
    Fix within (example)
    Nothing to fix

  • Not checked

    What it means
    Not seen on this walk, such as an area that was not running. Left out of the score.
    Fix within (example)
    Check it on the next walk

The 55 checks

What to check, by section of 21 CFR 117 subpart B

Each check starts with the paragraph it comes from, asks one question in plain words and says what to look at. On the sheet each one gets a grade (OK, Minor, Major, Critical, N/A or Not checked), the finding and an owner. The questions paraphrase the rule; read the paragraph itself when a finding is disputed.

Personnel (117.10 and 117.4)

Health, hygiene, clothing and training

  1. 1117.10(a): Are illnesses, open sores and infected wounds reported to a supervisor, and is anyone affected kept off work that could contaminate food, food-contact surfaces or packaging unless the wound has an impermeable cover? Look at: ask two operators what they would report; hands and forearms on the line; last month's exclusion records.
  2. 2117.10(b)(1), (b)(6): Does everyone in the area wear clean outer garments suited to the work, and hair and beard restraints that cover fully? Look at: smocks worn outside or in toilets, hair showing at the front of nets, beard covers, visitors and maintenance staff.
  3. 3117.10(b)(3): Do people wash their hands before starting work, after every absence from the work station and whenever their hands may be soiled? Look at: stand at a production entrance for 10 minutes after a break and count washes against people coming in.
  4. 4117.10(b)(4), (b)(5): Is loose jewelry removed, hand jewelry that cannot be sanitized removed or covered, and are gloves used on food intact and clean? Look at: watches, rings, earrings, pens in top pockets; torn gloves; gloves that touch bins or the floor and then food.
  5. 5117.10(b)(7), (b)(8): Are personal belongings kept out of areas where food is exposed or equipment is washed, and are eating, drinking, gum and tobacco kept out of them too? Look at: phones, bottles, snacks and coats on the line, in the wash bay and on packing tables.
  6. 6117.4(b)(2), (d): Has everyone who handles food, temporary and seasonal staff included, been trained in food hygiene, food safety and personal hygiene for their job, with a record? Look at: pick three names from today's rota, one of them a temp, and find their training records.

Plant and grounds (117.20)

Outside, building, light, air and pest-proofing

  1. 7117.20(a)(1), (a)(4): Are the grounds next to the building free of litter, stored junk equipment and long weeds or grass, and is the waste area run so it does not draw pests? Look at: walk the outside wall; pallet stacks, scrap equipment, weeds against the wall, dumpster lids and spillage.
  2. 8117.20(a)(2), (a)(3): Are roads, yards and parking kept and drained so they do not carry dirt or standing water toward areas where food is exposed? Look at: puddles by doors and docks, mud or dust tracked inside, blocked yard drains.
  3. 9117.20(a)(5): Where neighboring land you do not control is poorly kept, do you inspect, trap or seal to keep its pests, dirt and filth out? Look at: the boundary on that side, perimeter stations on the pest contractor's map. N/A when the neighbors keep their land in order.
  4. 10117.20(b)(3): Are outdoor bulk vessels such as silos and tanks covered, free of pest harborage around them and checked for pests on a schedule? Look at: hatches, vents and filters, spilled product around the base, the inspection record. N/A if there are none.
  5. 11117.20(b)(1), (b)(4): Is there room to clean and maintain around equipment and stored materials, with aisles clear and wide enough to work without brushing against food or packaging? Look at: materials stacked against walls, equipment nobody can get behind, blocked aisles.
  6. 12117.20(b)(2): Are operations that could cause allergen cross-contact or contamination kept apart by location, time, partition, air flow, dust control or enclosure? Look at: raw and ready-to-eat areas, where allergens such as sesame or nuts are handled, flour dust drifting to other lines.
  7. 13117.20(b)(4): Are floors, walls and ceilings cleanable, clean and in good repair? Look at: cracked tiles holding water, peeling paint or flaking ceiling above product, holes in walls, broken wall-to-floor joints.
  8. 14117.20(b)(4): Is there no drip or condensate from fixtures, ducts or pipes onto food, food-contact surfaces or packaging? Look at: look up above every point where product is open; cold pipes, ceilings above ovens, kettles and chillers.
  9. 15117.20(b)(5): Is there enough light where food is examined, processed, packed or stored, where equipment is cleaned, and in hand-wash areas, locker rooms and toilets? Look at: dark corners of the wash bay, inspection points, storage aisles.
  10. 16117.20(b)(5): Are bulbs, fixtures, skylights and other glass above exposed food shatter-resistant or otherwise protected against breakage? Look at: light covers fitted and uncracked over every open-product point, the glass and brittle plastic register if you keep one.
  11. 17117.20(b)(6): Does ventilation keep dust, steam, odors and vapors from reaching food, and are fans placed so they do not blow onto exposed food or spread allergens? Look at: pedestal fans aimed at the line, condensation from steam, dust settling on packaging.
  12. 18117.20(b)(7): Are doors, windows, vents and other openings screened or otherwise protected against pests? Look at: dock doors left open, daylight under doors, torn screens, gaps around pipes and cables through walls.

Sanitary operations (117.35)

Cleaning, chemicals and pest control

  1. 19117.35(a): Is cleaning done in a way that does not spread allergens or contamination to food, food-contact surfaces or packaging? Look at: high-pressure hoses near open product or cleaned equipment, cleaning next to a running line, dirty tools on food-contact surfaces.
  2. 20117.35(b)(1): Are cleaning compounds and sanitizers safe and suitable for their use, with proof such as a supplier's letter of guarantee or a certificate? Look at: the approved chemical list against what is on the shelves, food-contact use on the labels, the supplier letters, dilution checks.
  3. 21117.35(b)(1), (b)(2): Are only the toxic materials the plant needs on site, and are all of them labelled and stored where they cannot contaminate food, food-contact surfaces or packaging? Look at: unlabelled spray bottles, chemicals on shelves above packaging, household products brought from home.
  4. 22117.35(c): Is there no sign of pests in any area? Look at: droppings, live or dead insects, gnawed bags, nests, birds inside, the catch in insect light traps, and the trend on the pest contractor's last reports.
  5. 23117.35(c): Are pests kept out by effective measures, and are pesticides used only with precautions that protect food, food-contact surfaces and packaging? Look at: the service records and site map, where baits and sprays are used, insect light traps placed so they are not above exposed food or packaging.
  6. 24117.35(d)(1), (d)(2): Are food-contact surfaces clean before use, dry where the food is low-moisture, and cleaned and sanitized after any interruption where food is wet-processed? Look at: the pre-operational check signed before start-up, residue on belts and scrapers, water left in dry equipment.
  7. 25117.35(d): Are food-contact surfaces cleaned as often as needed to prevent allergen cross-contact and contamination, including at allergen changeovers? Look at: the cleaning schedule against what you see, the last allergen changeover record and how it was checked.
  8. 26117.35(e): Are non-food-contact surfaces of equipment cleaned often enough to protect food and food-contact surfaces? Look at: build-up under conveyors, on guards, motor covers, oven tops and frames.
  9. 27117.35(d)(3), (f): Are cleaned portable equipment, utensils and single-use items such as gloves and paper towels stored so they stay clean? Look at: scoops and tools on the floor, clean bins stored open side up under dust, open boxes of gloves.

Sanitary facilities and controls (117.37)

Water, plumbing, drains, toilets, hand washing, rubbish

  1. 28117.37(a): Is water that touches food, food-contact surfaces or packaging safe and of adequate sanitary quality, with running water at a suitable temperature and pressure where it is needed? Look at: the latest water test or the supplier's report, hot water at the wash bay and sinks.
  2. 29117.37(b)(3), (b)(5): Is there no backflow or cross-connection between waste water or sewage piping and the water used for food? Look at: backflow preventers on hose points and tank fills, their test records, hose ends lying in drains or tanks.
  3. 30117.37(b)(4): Do floors that are wet-cleaned or get water from the process drain without pooling? Look at: standing water, blocked or smelly drains, missing drain covers.
  4. 31117.37(d): Are toilets adequate, easy to reach, clean and kept so they cannot contaminate food, food-contact surfaces or packaging? Look at: cleanliness, soap and towels, the cleaning log, smocks left outside the toilet area.
  5. 32117.37(e): Are there hand-wash sinks where they are needed, easy to reach, with running water at a suitable temperature? Look at: every sink at a production entrance: not blocked, hot water, soap, single-use towels or a dryer, used only for hands.
  6. 33117.37(f): Are rubbish and waste inside the plant held and removed so they do not smell, attract pests or contaminate food? Look at: lidded, marked waste bins in production, bins emptied before they overflow, waste containers never used for food.

Equipment and utensils (117.40)

Design, condition, cold stores, instruments, compressed air

  1. 34117.40(a)(1), (a)(3), (c), (d): Is equipment cleanable, kept in good repair and installed so it and the space around it can be cleaned? Look at: temporary repairs with tape, cable ties or cardboard; hollow parts that trap food; equipment hard up against walls.
  2. 35117.40(a)(2): Is equipment built and used so that lubricant, fuel, metal fragments or contaminated water cannot get into food? Look at: grease on bearings above product, missing drip trays, loose or broken metal parts, worn blades and screens.
  3. 36117.40(a)(4) to (a)(6), (b): Are food-contact surfaces corrosion-resistant, nontoxic, in good condition and smoothly joined at the seams? Look at: rust, pitting, cracked plastic, frayed belts, rough welds, scored or porous boards.
  4. 37117.40(e): Does every freezer and cold store holding food that can support microbial growth have a thermometer or recorder that shows the temperature inside accurately? Look at: read the display, compare it with a calibrated probe, check the log.
  5. 38117.40(f): Are instruments that measure or control temperature, pH, acidity or water activity accurate, maintained and enough in number? Look at: calibration labels and records, the last check of each probe, missing or broken instruments.
  6. 39117.40(g): Is compressed air or other gas that touches food or food-contact surfaces treated so it does not contaminate food? Look at: the filters on that air line and their change record. N/A if no air or gas touches food or food-contact surfaces.

Processes and controls (117.80)

Supervision, ingredients, allergens, temperature, foreign material, packing

  1. 40117.80(a)(3): Is one or more competent person named as responsible for overall plant sanitation? Look at: the name, the job description, who covers on nights and during holidays.
  2. 41117.80(a)(5): Are chemical, microbial or foreign-material tests used where needed to find sanitation failures or allergen cross-contact? Look at: the swab or test plan, the last results, what was done about any positive result.
  3. 42117.80(a)(6), (c)(9): Is contaminated or adulterated food rejected, held where it cannot reach other food, and disposed of or reconditioned only by a proven method? Look at: the hold area and hold tags, the hold log, nothing on hold mixed in with released stock.
  4. 43117.80(b)(1): Are raw materials and other ingredients inspected at receipt and stored so they stay clean and protected and do not deteriorate? Look at: the receiving check (damage, pests, seals, temperature), certificates of analysis, materials off the floor.
  5. 44117.80(b)(5), (b)(6): Are ingredients and rework held in protective containers at the right temperature and humidity, is rework labelled as rework, and are frozen materials kept frozen and thawed safely? Look at: open bags, scoops left in bins, unlabelled rework tubs, thawing on the floor.
  6. 45117.80(b)(8), (c)(5): Are allergen ingredients, and rework and work in process that contain allergens, identified and held so they cannot cross-contact other food? Look at: allergen labels or colors on bins, dedicated scoops, allergens stored where a spill cannot fall onto other ingredients.
  7. 46117.80(c)(2), (c)(3): Is food that can support rapid microbial growth held at temperatures that keep it from becoming adulterated during processing and holding? Look at: product or work in process waiting at room temperature, chiller and holding temperatures, how long product sits.
  8. 47117.80(c)(6), (c)(13): Is finished food protected from raw materials, refuse and allergens, and are filling and packing done so the food stays protected? Look at: waste carts passing open product, raw and finished goods side by side at the dock, packaging stored open or on the floor.
  9. 48117.80(c)(8): Are there working measures against metal and other foreign material, such as sifter screens, magnets or metal detectors, and are they checked? Look at: the metal detector check on this shift, sifter screens intact, what happens to rejected product.
  10. 49117.80(c)(12): Are batters, glazes, washes, sauces and similar preparations that are held and reused over time protected from contamination, allergen cross-contact and microbial growth? Look at: how long they are kept, at what temperature, covered or not, when the container is cleaned. N/A if none.
  11. 50117.80(c)(14), (c)(15): Where safety relies on water activity, or on pH for acid and acidified food (4.6 or below), is it monitored and kept at the safe level? Look at: the target, the last readings and who checks them. N/A if your products rely on neither.

Warehousing and distribution (117.93)

Storage and transport

  1. 51117.93: Is food stored so it is protected from allergen cross-contact, contamination and deterioration of the food and its container? Look at: pallets off the floor and away from walls, damaged packs set aside, no chemicals stored over food, stock rotation.
  2. 52117.93: Are trucks and containers checked before loading so food is not contaminated in transport? Look at: the trailer inspection record and a trailer at the dock now: clean, dry, no odor or pests, in repair, at temperature if chilled.

Defect action levels and by-products (117.110, 117.95)

Natural defects and food going to animal feed

  1. 53117.110(a): Do quality control operations keep natural or unavoidable defects, such as insect fragments, rodent hair or mold, as low as currently feasible? Look at: ingredient specifications, supplier certificates, sifting or cleaning steps, FDA's Food Defect Levels Handbook entry for your main ingredients.
  2. 54117.110(b): Does everyone who decides on held stock know that a lot with defects at an adulterating level must never be blended into other lots to bring the level down? Look at: the hold and rework procedure; ask the production lead what they would do with such a lot.
  3. 55117.95: If human food by-products go to animal feed, are they held in clean containers away from trash, identified, labelled with their common name and shipped in examined containers? Look at: the by-product bins or skips, their labels, the container check. N/A if none.

A filled-in example

Illustrative, not a benchmark

An example: the monthly walk at a made-up bread and bun bakery with two lines, a flour silo outside and sesame topping on line 2, walked by the QA lead, the production manager and a line 2 operator (illustrative).

  • 55 checks. 2 are N/A (the neighbors keep their land in order; the food safety plan does not rely on water activity or pH) and 1 is not checked (the air filter to the bun slicer sits behind a guard), so 52 are graded.
  • 45 OK, 4 Minor, 3 Major and no Critical.
  • Major: the hand-wash sink at the line 2 entrance blocked by bun trays, a cracked light cover over open dough on line 1, and an unlabelled spray bottle on the line 2 packing table.
  • Minor: a contractor's wristwatch in packing, flour spilled around the silo base, daylight under dock door 3, and two crushed cases of buns not set aside.
  • Plant and grounds produced the most findings: 3 of its 11 graded checks, a section score of 72.7%.

Score 45 ÷ 52 = 86.5%, up from 84.3% the month before. Ten days after the walk, 4 of the 7 findings are closed (3 during the walk, 1 the next day) and 3 are open. The light cover is 3 days past its 7-day due date: the one to chase.

Common mistakes

  • Grading the paperwork, not the floor

    A signed cleaning schedule does not mean the belt is clean. Look at the surface, the drain and the space over open product, and ask the operator. Check the records at the last stop, against what you saw.

  • Walking when nothing runs

    Hand washing, condensation dripping over product, how rework and dropped product are handled: many checks can only be judged with the line running. Walk in production, and mark what you could not see as Not checked, never OK.

  • Findings nobody can act on

    "Housekeeping poor" gets a shrug. A finding with what, where, a photo and one owner gets fixed.

  • Treating the score as a pass mark

    A 95% walk with one Critical finding is worse than an 85% walk without one. Use the score to compare your own walks month to month, and act on every Critical and Major finding whatever the total.

  • Closing findings on the owner's word

    A finding closed without anyone checking the fix comes back next month. Someone other than the owner checks it, and a finding that keeps coming back goes on a corrective action form with a root cause.

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