FSMA Compliance Checklist

Use this FSMA Compliance Checklist to audit and inspect food manufacturing and processing facilities against FDA requirements under 21 CFR Part 117.

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FSMA Compliance Checklist



Personnel And Training (§117.10, §117.4)

1. All personnel working in direct contact with food, food-contact surfaces, or food-packaging materials have documented food hygiene training appropriate to their role.


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2. Personnel showing signs of illness, open lesions, or other conditions that could result in food contamination are excluded from food handling areas.


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3. All personnel in food handling areas wear clean outer garments and use effective hair restraints.


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4. Personnel do not eat, drink, chew gum, or use tobacco in areas where food may be exposed to contamination.


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5. A Preventive Controls Qualified Individual (PCQI) has been designated for this facility and holds documented evidence of FSPCA training or equivalent qualification (§117.126(a)).


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6. Training records for all food safety personnel are current, signed, and retained on site.


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Plant, Grounds, And Facility (§117.20)

1. Grounds surrounding the facility are maintained to prevent harborage of pests, pooling of water, or contamination of food.


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2. The facility is constructed and maintained to prevent entry of pests, environmental contaminants, and cross-contamination between raw and finished product areas.


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3. Adequate lighting is installed in all food handling, inspection, and storage areas.


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4. Adequate ventilation is provided to minimise condensation, dust, and airborne contamination in food production areas.


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5. Floors, walls, and ceilings in food contact areas are in good repair and cleanable.


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6. Plumbing is sized and maintained to carry adequate water supply and to prevent backflow or cross-connection between potable and non-potable water systems (§117.37).


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Equipment And Utensils (§117.40)

1. All food-contact equipment and utensils are constructed of materials that are non-toxic, non-absorbent, and cleanable under normal operating conditions.


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2. Equipment is installed and maintained to facilitate cleaning of the equipment and adjacent areas.


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3. Seams on food-contact surfaces are smooth and maintained to minimise accumulation of food particles and microorganisms.


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4. Temperature-measuring devices used in food safety controls are calibrated on a documented schedule and records are retained.


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5. Non-food-contact equipment is maintained in good repair and does not create a contamination risk to food or food-contact surfaces.


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Sanitary Operations (§117.35)

1. Cleaning and sanitising schedules covering all food-contact surfaces are documented, implemented, and verified.


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2. Cleaning compounds and sanitising agents are safe and adequate under intended conditions of use, and approved for food facility use.


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3. Food-contact surfaces are cleaned and sanitised before use, after any interruption where contamination may have occurred, and at intervals sufficient to protect against contamination.


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4. Toxic cleaning compounds, sanitising agents, and pesticides are clearly labelled, stored separately from food, and managed to prevent contamination of food or food-contact surfaces.


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5. Pest control measures are active, documented, and effective; evidence of pest activity is absent from food handling and storage areas.


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Sanitary Facilities (§117.37)

1. Adequate hand-washing facilities with running water, soap, and single-use towels or air dryers are available at all required locations.


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2. Hand-washing signage is posted at all sinks used by food handlers.


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3. Toilet facilities are maintained in good repair, adequately ventilated, and do not open directly into food handling areas.


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4. Sewage and liquid waste disposal systems are adequate and maintained to prevent contamination of food, water supply, or food-contact surfaces.


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Processes And Controls (§117.80)

1. Raw materials and ingredients are inspected on receipt and are from approved sources or subject to verification before use.


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2. Raw materials requiring refrigeration are stored and held at appropriate temperatures; records of storage temperatures are maintained.


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3. Food manufacturing operations are conducted under conditions that minimise the potential for contamination by allergens, filth, and microorganisms.


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4. Rework is handled, labelled, and controlled to prevent allergen cross-contact and microbial contamination.


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5. Finished product is held under conditions that protect against contamination until released for distribution.


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Food Safety Plan Documentation (§117.126)

1. A written food safety plan (FSP) specific to this facility exists and is accessible on site.


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2. The FSP was prepared or its preparation overseen by the designated PCQI.


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3. The FSP has been reviewed and, where applicable, reanalysed within the past three years or following any change that could affect the hazard analysis (§117.170).


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4. The FSP includes all required written components: hazard analysis, preventive controls, supply-chain programme, and recall plan.


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5. The FSP is version-controlled and the current version is dated and identified.


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Hazard Analysis (§117.130)

1. A written hazard analysis has been conducted for each food type manufactured, processed, packed, or held at the facility.


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2. The hazard analysis addresses known or reasonably foreseeable biological, chemical (including radiological), and physical hazards.


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3. The hazard analysis evaluates the severity of illness or injury and the probability of the hazard occurring in the absence of preventive controls.


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4. The outcome of the hazard analysis — whether or not a preventive control is required — is documented regardless of the conclusion.


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5. Hazards identified as requiring a preventive control are carried forward into the preventive controls section of the FSP.


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Process Preventive Controls (§117.135)

1. Written process preventive controls are established for each hazard identified as requiring a preventive control.


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2. Critical limits or other parameters are defined for each process preventive control.


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3. Monitoring procedures specifying what is monitored, how, the frequency, and who is responsible are documented for each process preventive control.


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4. Corrective action procedures are established and documented for instances where process preventive controls are not properly implemented or verified.


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5. Validation records demonstrate that process preventive controls are capable of controlling the identified hazard to the required level (§117.160).


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Allergen Controls (§117.135(c))

1. All allergenic ingredients used at the facility are identified in the FSP and allergen cross-contact hazards are addressed.


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2. Procedures are in place to prevent allergen cross-contact during storage, handling, processing, and packaging.


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3. Label verification procedures confirm that finished product labels correctly declare all allergenic ingredients present.


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4. Equipment shared between allergen-containing and allergen-free product lines is subject to documented allergen cleaning validation.


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5. Rework containing allergens is labelled and controlled to prevent undeclared allergen cross-contact.


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Sanitation Controls (§117.135(e))

1. Written sanitation controls address the cleanliness of food-contact surfaces and prevention of allergen cross-contact and cross-contamination with biological and chemical hazards.


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2. Sanitation monitoring records are maintained and reviewed at a frequency adequate to provide assurance that controls are consistently applied.


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3. Environmental monitoring is conducted for facilities where Listeria or other environmental pathogens represent a significant hazard, and results are documented and trended.


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4. Corrective actions taken in response to sanitation failures or positive environmental test results are documented, including root cause and disposition of affected product.


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Supply-Chain Programme (§117.410–§117.475, Subpart G)

1. A written supply-chain programme is in place covering all raw materials and ingredients for which a supply-chain-applied control is required.


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2. Approved supplier status is documented for all raw material and ingredient suppliers subject to supply-chain controls.


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3. Supplier verification activities (e.g., on-site audits, certificates of analysis, lot-by-lot testing) are performed at a frequency commensurate with the risk level of the ingredient and supplier.


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4. Records of supplier approval, verification activities, and corrective actions are retained and up to date.


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5. Unapproved raw materials or ingredients are not used in production without documented risk assessment and management approval.


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Recall Plan (§117.139)

1. A written recall plan is included in the FSP and covers procedures for notifying consignees, the public where applicable, and FDA.


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2. Roles and responsibilities for executing the recall plan are assigned to named individuals or positions.


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3. A mock recall or recall effectiveness check has been conducted within the past 12 months and the outcome is documented.


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4. Traceability records are sufficient to identify the lot, batch, or production run of any recalled product and its distribution.


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Monitoring And Verification Records (§117.145, §117.165)

1. Monitoring records for all preventive controls are completed at the required frequency, signed by the responsible individual, and retained on site.


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2. Records are legible, accurate, and created at the time the activity was performed; no retroactive entries without documented justification.


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3. A PCQI or designee reviews monitoring records within the timeframes required by §117.165.


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4. Verification records — including calibration logs, validation studies, environmental monitoring results, and supplier verification — are current and accessible.


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5. All records required under 21 CFR Part 117 are retained for at least two years and are available for FDA review within 24 hours of request (§117.305).


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Corrective Actions And CAPA (§117.150)

1. Corrective action procedures are documented and specify actions to be taken when preventive controls are not properly implemented.


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2. Each corrective action record identifies the deviation, the root cause (where determinable), corrective action taken, and disposition of affected product.


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3. Products that may have been affected by a process deviation are evaluated and either reprocessed, destroyed, or diverted to an acceptable non-food use; release to commerce is documented and justified.


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4. Corrective action records are reviewed by the PCQI and retained as part of the FSP records.


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5. Recurring deviations for the same control point trigger a formal review and update of the relevant preventive control or FSP element.


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Checklist by GoAudits.com – Please note that this checklist is intended as an example. We do not guarantee compliance with the laws applicable to your territory or industry. You should seek professional advice to determine how this checklist should be adapted to your workplace or jurisdiction.

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