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QA Managers, Production SupervisorsInteractive Tool

Food Manufacturing GMP & Sanitation Inspection Checklist

This checklist is designed for QA Managers and Production Supervisors to conduct thorough pre-shift line clearance and GMP audits. Consistent application of these checks will minimize cross-contamination risks, control allergens, and prevent costly FDA recalls. Use this tool to maintain the highest standards of food safety in your facility.

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General-purpose starting point only. Adapt it to the site, manufacturer instructions, and applicable local requirements. It does not replace a competent person's assessment or a required statutory form.

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Primary Risks

  • •Cross-contamination (biological, chemical, allergenic)
  • •Pest infestation and harborage
  • •Inadequate sanitation leading to foodborne illness

Standards and rules to review

  • •21 CFR Part 117 (Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food)
  • •21 CFR Part 110 (Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food)
  • •HACCP Principles

Inspection Items

Mark each item Not checked, OK, Issue or N/A. Only issues become findings — Not checked is not a failure.

0/53 answered
OK 0Issue 0N/A 0Not checked 53
1

Mark each item OK, Issue or N/A in the field

2

Only items you mark as Issue become findings in your report

3

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Legend: Critical = stop work · Major = fix before climb · Minor = monitor

Facility Exterior & Grounds

0/10 answered

Perimeter fencing is intact and secure, preventing unauthorized access. (21 CFR 117.80(a)(1))

MajorRef: 21 CFR 117.80(a)(1)

Waste disposal areas are clean, covered, and located away from production areas to prevent pest attraction. (21 CFR 117.35(c))

MajorRef: 21 CFR 117.35(c)

No standing water is present around the facility perimeter, eliminating potential breeding grounds for pests. (21 CFR 117.35(c))

MajorRef: 21 CFR 117.35(c)

Vegetation around the building is trimmed and maintained to minimize pest harborage. (21 CFR 117.35(c))

MinorRef: 21 CFR 117.35(c)

Loading dock seals are in good repair, effectively sealing gaps to prevent pest entry during loading/unloading. (21 CFR 117.80(a)(1))

MajorRef: 21 CFR 117.80(a)(1)

Exterior lighting is adequate and functional, providing visibility and deterring pests. (21 CFR 117.80(a)(1))

MinorRef: 21 CFR 117.80(a)(1)

Dumpsters are clean, properly covered, and emptied regularly to prevent pest and odor issues. (21 CFR 117.35(c))

MajorRef: 21 CFR 117.35(c)

Exterior drainage systems are clear of debris and functioning properly to prevent water accumulation. (21 CFR 117.35(c))

MinorRef: 21 CFR 117.35(c)

Rodent bait stations are present, properly maintained, and documented on a site map. (21 CFR 117.35(c))

MajorRef: 21 CFR 117.35(c)

Bird control measures (netting, spikes) are in place and effective to prevent bird entry and nesting. (21 CFR 117.35(c))

MajorRef: 21 CFR 117.35(c)

Production Area Sanitation

0/11 answered

All food contact surfaces are visibly clean and free from product residue. (21 CFR 117.35(a))

CriticalRef: 21 CFR 117.35(a)

Cleaning and sanitation schedules are followed and documented for all equipment and areas. (21 CFR 117.35(b))

MajorRef: 21 CFR 117.35(b)

Sanitizer concentrations are within the specified range and documented. (21 CFR 117.35(a))

MajorRef: 21 CFR 117.35(a)

ATP swab tests are conducted regularly, and results are within acceptable limits (specify RLU threshold). (21 CFR 117.35(a))

MajorRef: 21 CFR 117.35(a)

Hand-washing stations are readily accessible, stocked with soap and sanitizer, and functioning properly. (21 CFR 117.10(b))

MajorRef: 21 CFR 117.10(b)

Floor drains are clean and free from debris to prevent bacterial growth and odors. (21 CFR 117.35(c))

MajorRef: 21 CFR 117.35(c)

Cleaning utensils are properly stored and sanitized to prevent cross-contamination. (21 CFR 117.35(a))

MajorRef: 21 CFR 117.35(a)

Trash receptacles are covered, emptied regularly, and cleaned/sanitized. (21 CFR 117.35(c))

MajorRef: 21 CFR 117.35(c)

Floors are clean, dry, and free from cracks or damage that could harbor bacteria. (21 CFR 117.20(b)(4))

MajorRef: 21 CFR 117.20(b)(4)

Walls and ceilings are clean, smooth, and free from condensation or peeling paint. (21 CFR 117.20(b)(4))

MajorRef: 21 CFR 117.20(b)(4)

Air handling systems are clean and properly maintained to prevent dust and mold contamination. (21 CFR 117.20(b)(4))

MajorRef: 21 CFR 117.20(b)(4)

Allergen Control

0/11 answered

Allergens are clearly labeled and stored separately from other ingredients to prevent cross-contamination. (21 CFR 117.35(a))

CriticalRef: 21 CFR 117.35(a)

Equipment used for allergen-containing products is thoroughly cleaned and sanitized after each use, with documented verification. (21 CFR 117.35(a))

CriticalRef: 21 CFR 117.35(a)

Cleaning procedures for allergen removal are validated to ensure effectiveness (e.g., ELISA testing). (21 CFR 117.35(a))

CriticalRef: 21 CFR 117.35(a)

An allergen matrix is in place, identifying all allergens present in the facility and their potential cross-contact points. (21 CFR 117.35(a))

MajorRef: 21 CFR 117.35(a)

Employees are trained on allergen awareness, handling procedures, and cleaning protocols. (21 CFR 117.4(b))

MajorRef: 21 CFR 117.4(b)

Rework procedures prevent allergen cross-contamination. Rework is clearly labeled and tracked. (21 CFR 117.35(a))

CriticalRef: 21 CFR 117.35(a)

Product labels accurately declare all allergens present in the product. (21 CFR 117.35(a))

CriticalRef: 21 CFR 117.35(a)

Production lines are physically segregated when handling products with different allergen profiles. (21 CFR 117.35(a))

MajorRef: 21 CFR 117.35(a)

Spill control procedures are in place to contain and clean up allergen spills immediately. (21 CFR 117.35(a))

MajorRef: 21 CFR 117.35(a)

Incoming ingredients are verified to be free of undeclared allergens. (21 CFR 117.80(c)(2))

MajorRef: 21 CFR 117.80(c)(2)

Line clearance procedures are documented and followed to ensure complete removal of allergens before switching products. (21 CFR 117.35(a))

CriticalRef: 21 CFR 117.35(a)

Pest Control

0/11 answered

A written pest control program is in place and implemented by a licensed pest control operator. (21 CFR 117.35(c))

MajorRef: 21 CFR 117.35(c)

Pest control records are maintained, including inspection reports, treatment details, and pesticide usage. (21 CFR 117.35(c))

MajorRef: 21 CFR 117.35(c)

All potential pest ingress points (holes, cracks, gaps) are sealed and maintained. (21 CFR 117.35(c))

MajorRef: 21 CFR 117.35(c)

Insect light traps (ILTs) are properly located, maintained, and monitored. (21 CFR 117.35(c))

MajorRef: 21 CFR 117.35(c)

Evidence of rodent activity (droppings, gnawing) is absent. (21 CFR 117.35(c))

CriticalRef: 21 CFR 117.35(c)

No bird droppings are present inside the facility. (21 CFR 117.35(c))

CriticalRef: 21 CFR 117.35(c)

Stored product pests (e.g., weevils, moths) are absent in ingredients and finished products. (21 CFR 117.35(c))

CriticalRef: 21 CFR 117.35(c)

Screens on windows and doors are intact and properly fitted. (21 CFR 117.35(c))

MajorRef: 21 CFR 117.35(c)

Air curtains at doorways are functioning correctly to prevent insect entry. (21 CFR 117.35(c))

MajorRef: 21 CFR 117.35(c)

Pest activity trends are analyzed to identify and address potential problem areas. (21 CFR 117.35(c))

MajorRef: 21 CFR 117.35(c)

Pesticides are applied only by trained and certified personnel, following label instructions. (21 CFR 117.35(c))

MajorRef: 21 CFR 117.35(c)

Personnel Practices

0/10 answered

Employees are observed washing hands properly and frequently, especially after breaks and using the restroom. (21 CFR 117.10(b))

MajorRef: 21 CFR 117.10(b)

Gloves are worn properly and changed frequently, especially when handling different products. (21 CFR 117.10(c))

MajorRef: 21 CFR 117.10(c)

Hair restraints (hairnets, beard covers) are worn properly to prevent hair contamination. (21 CFR 117.10(a))

MajorRef: 21 CFR 117.10(a)

Clean outer garments are worn in production areas. (21 CFR 117.10(a))

MajorRef: 21 CFR 117.10(a)

Jewelry is removed or covered to prevent physical contamination. (21 CFR 117.10(a))

MajorRef: 21 CFR 117.10(a)

Eating, drinking, and smoking are prohibited in production areas. (21 CFR 117.10(a))

MajorRef: 21 CFR 117.10(a)

Employees with signs of illness (e.g., diarrhea, vomiting) are excluded from food handling. (21 CFR 117.10(e))

CriticalRef: 21 CFR 117.10(e)

Cuts and abrasions are properly covered with waterproof bandages. (21 CFR 117.10(c))

MajorRef: 21 CFR 117.10(c)

Personal items (purses, phones) are stored outside of production areas. (21 CFR 117.10(a))

MajorRef: 21 CFR 117.10(a)

Appropriate footwear is worn in production areas (closed-toe, non-slip). (21 CFR 117.10(a))

MajorRef: 21 CFR 117.10(a)

Expert Field Tips

01

Focus on high-risk areas: product contact surfaces, allergen handling zones, and pest entry points.

02

Use ATP swabbing as a rapid verification tool for cleaning effectiveness.

03

Regularly review and update your GMP and sanitation programs based on audit findings and industry best practices.

Frequently asked questions

How often should a GMP & Sanitation Checklist: Food Manufacturing be performed?

The frequency of a GMP & Sanitation Checklist: Food Manufacturing depends on site-specific risks and regulatory requirements. Typically, these inspections are conducted before each shift, weekly, or after any significant change in site conditions as per 21 CFR Part 117 (Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food).

Who is qualified to conduct a GMP & Sanitation Checklist: Food Manufacturing?

A "competent person" as defined by 21 CFR Part 117 (Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food) should perform this inspection. This individual must have the knowledge, training, and experience to identify existing and predictable hazards in the specific work environment.

What regulation or standard covers GMP & Sanitation Checklist: Food Manufacturing?

This inspection type is primarily governed by 21 CFR Part 117 (Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food). Specialized local regulations and manufacturer specifications may also apply and should be consulted during the inspection process.

What are the most common findings in a GMP & Sanitation Checklist: Food Manufacturing?

Frequent issues identified during a GMP & Sanitation Checklist: Food Manufacturing include missing documentation, improper storage of materials, wear and tear on structural components, and non-compliance with safety signage requirements.

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