FSMA Human Food Audit Checklist

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FSMA Human Food Audit ChecklistIowa State University Extension and OutreachDepartment of Food Science and Human NutritionThe Food Safety Modernization Act (FSMA) was signed into law on January 4, 2011. FSMA isthe largest change in food safety law since the Food, Drug, and Cosmetic Act was first passed in1938. FSMA seeks to 1) Prevent foodborne illness; 2) Improve inspection, compliance, andresponse; 3) Improve safety of imported foods and; 4) Improve miscellaneous provisions andenhance partnerships.This Checklist focuses on manufacturers of human food. It will help you organize your materialsand assess your current food safety preparedness. The Checklist is NOT itself a plan; it is only anassessment tool to assist in the development of your own plan. This Checklist has four main parts:1) Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117 Subpart C); 2) CurrentGood Manufacturing Practices (21 CFR Part 117 Subpart B); 3) Sanitary Transportation of Humanand Animal Food (21 CFR Part 1 Subpart O); and 4) Registration of Food Facilities (21 CFR Part1 Subpart H). It is recommended to do one part at a time and collect/list documentation in eachpart as you go. If the answer to a question is no, put no; then this will be an area to improve. Thischecklist is for your use only; it is not a regulatory compliance program.Hazard Analysis and Risk-Based Preventive Controls:1) Preventive Controls Qualified Individual – §117.180(c)(1)2) Contents of a Food Safety Plan – §117.1263) Hazard Analysis – §117.1304) Preventive Controls for Hazards – §117.1355) When Preventive Controls are not Required – §117.1366) Recall Plan – §117.1397) Monitoring – §117.1458) Corrective Actions – §117.1509) Verification – §117.155, 16510) Validation – §117.16011) Reanalysis – §117.17012) Records Required – §117.190Current Good Manufacturing Practices:1) Qualified Individual – §117.42) Personnel – §117.103) Plant and grounds – §117.204) Sanitary operations – §117.355) Sanitary facilities and controls – §117.376) Equipment and utensils – §117.407) Processes and controls – §117.808) Warehousing and distribution – §117.93, §1.9089) Holding and distribution of human food by-products for use as animal food – §117.9510) Defect action levels – §117.110

V. 1.2; 12/19/2017 Copyright 2016-2020, Iowa State University of Science and Technology. All RightsReserved.Sanitary Transportation of Human and Animal Food:1) Who is subject to Sanitary Transportation rule? – §1.9002) How does this information apply under the Food, Drug, and Cosmetic Act? – §1.9023) What requirements apply to vehicles and transportation equipment? – §1.9064) What are the general requirements for transportation operations? – §1.908(a)5) What requirements are applicable to shippers engaged in transportation operations? –§1.908(b)6) What are the requirements applicable to loaders and receivers engaged in transportationoperations? – §1.908(c) and (d)7) What are the requirements applicable to carriers engaged in transportation operations? –§1.908(e)8) What training requirements apply to carriers engaged in transportation operations? –§1.9109) What record retention and other records requirements apply to shippers, receivers, loaders,and carriers engaged in transportation operations? – §1.91210) How are waiver requests submitted? – §1.914 - §1.934Registration of Food Facilities:1) Who must register? – §1.2252) Who does not have to register? – §1.2263) When must you register or renew your registration? – §1.2304) How and where do you register or renew your registration? – §1.2315) What information is required in the registration? – §1.2326) How and when do you update your facility’s registration information? – §1.2347) How and when do you cancel your facility’s registration information? – §1.2358) How are waiver requests submitted? – §1.245We welcome input and suggestions. It may be possible to tailor versions of the Checklist tospecific industries. This Checklist does not make distinctions among industries in the applicationof preventive controls. However, the Current Good Manufacturers Practices and PreventiveControls for Human Food (CGMP & PC) rule does describe several exemptions from the rule, orcertain provisions of the rule, including exemptions based on size of business, activities conducted,and types of products. All the provisions apply to all non-exempt industries and facilities regulatedby FDA.Contact:Dr. Angela ShawIowa State UniversityAssistant Professor/Extension and OutreachFood Safety/Microbiology2577 Food Science, Ames, IA515-294-0868angelaml@iastate.eduJacques Overdiep IIIIowa State UniversityGraduate Research AssistantFood Safety/Microbiology2555 Food Science, Ames, IA919-721-7538overdiep@iastate.eduThese materials are provided for educational and informational purposes only. The materials are not a substitute forprofessional advice, whether legal or otherwise. Users are responsible for any consequences resulting from their useof the materials. Copying and redistribution without change is allowed with attribution.Food Safety Checklist for Human Food2

V. 1.2; 12/19/2017 Copyright 2016-2020, Iowa State University of Science and Technology. All RightsReserved.Hazard Analysis and Risk-based Preventive ControlsHazard Analysis and Risk-Based Preventive Controls Checklist Part 1 – §117.180(c)(1)1.11.21.3Preventive Controls Qualified IndividualYesNoN/ADocumentsIdentify a preventive controls qualified individual withfood safety training and/or education.Hint: A preventive controls qualified individual has job experience in the development andapplication of a food safety system or has successfully finished training in the development andapplication of risk-based preventive controls at least equivalent to the standardized curriculumrecognized as adequate by FDA. Currently, the standardized curriculum recognized as adequate byFDA is that offered by the Food Safety Preventive Controls Alliance. The preventive controlsqualified individual does not have to be an employee of the company.Documentation of training of the preventive controlsqualified individual.Hint: Records of training completed by preventive controls qualified individuals should include thedate, type of training, the people trained, if applicable.You may wish to establish a food safety team.Hint: A multifaceted team with a variety of expertise that can contribute to food safety riskassessment. This can help bring expertise from various areas of operation as well as provide a wellinformed group to help develop and implement the food safety plan.Comments:A preventive controls qualified individual must do or oversee: the preparation of the food safety plan,validation of the preventive controls, review of records, reanalysis of the food safety plan, and ifnecessary, the determination that validation is not required.Definitions (§117.3):Facility means a domestic facility or a foreign facility that is required to register under section 415 of the Federal Food,Drug, and Cosmetic Act, in accordance with the requirements of part 1, subpart H of 21 CFR 117.FDA means the Food and Drug Administration.Preventive controls means those risk-based, reasonably appropriate procedures, practices, and processes that a personknowledgeable about the safe manufacturing, processing, packing, or holding of food would employ to significantlyminimize or prevent the hazards identified under the hazard analysis that are consistent with the current scientificunderstanding of safe food manufacturing, processing, packing, or holding at the time of the analysis.Qualified individual means a person who has the education, training, or experience (or a combination thereof) necessaryto manufacture, process, pack, or hold clean and safe food as appropriate to the individual's assigned duties. A qualifiedindividual may be, but is not required to be, an employee of the establishment.Preventive controls qualified individual (PCQI) means a qualified individual who has successfully completed training inthe development and application of risk-based preventive controls at least equivalent to that received under a standardizedcurriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a foodsafety system.Significantly minimize means to reduce to an acceptable level, including to eliminate.Validation means obtaining and evaluating scientific and technical evidence that a control measure, combination ofcontrol measures, or the food safety plan as a whole, when properly implemented, is capable of effectively controlling theidentified hazards.Food Safety Checklist for Human Food2

V. 1.2; 12/19/2017 Copyright 2016-2020, Iowa State University of Science and Technology. All RightsReserved.Hazard Analysis and Risk-Based Preventive Controls Part 2 – §117.1262.12.22.32.42.5Contents of a Food Safety Plan OverviewFood Safety Plan includes a hazard analysis.YesNoN/ADocumentsHint: Identify and evaluate all known or foreseeable hazards for each food manufactured,processed, packed, or held at the facility.Food Safety Plan must include preventive controls if thehazard analysis concludes there is/are a hazard(s)requiring preventive controls.Hint: Identify and implement preventive controls to provide assurance that hazards requiring apreventive control appropriate to the food being processed would be significantly minimized orprevented. The food safety plan may also include documentation as to why a critical controlpoint is not a preventive control.Food Safety Plan may include supply-chain program.Hint: Establish a program to accept or reject raw materials and other ingredients for whichhazard(s) requiring a preventive control have been identified before they enter the facility.Written procedures should describe how each item is received and/or rejected. They should alsodescribe how supplier verification activities are conducted for each supplier, including temporaryand replacement suppliers. Replacement and temporary suppliers should have the sameacceptance criteria as regular suppliers.Food Safety Plan must include a recall plan if apreventive control is identified.Hint: Written protocol that describes steps to be taken during a recall.2.7Food Safety Plan must include monitoring procedureswhen appropriate to the preventive control.Hint: Establish written procedures that ensure preventive controls are consistently performed aswritten in the food safety plan.Food Safety Plan includes corrective action procedures ifa preventive control is identified.Hint: Written procedures to be taken if preventive controls are not properly implemented tocorrect the issue.Food Safety Plan includes written validation andverification procedures if a preventive control isidentified.Hint: See the FDA definition of validation below. Validation is required for process preventivecontrols. Validation documentation explains how the established preventive controls arescientifically and technically acceptable for the control of a hazard requiring a preventivecontrol. Verification includes the application of methods, procedures, tests, and otherevaluations, in addition to monitoring, to determine whether a control measure or combination ofcontrol measures is or has been operating as intended and to establish the validity of the foodsafety plan.2.8Food Safety Plan must include record keeping.2.6Hint: If a preventive control is identified then records for implementation must be kept on themonitoring, corrective actions, verification of validation, reanalysis, and record reviewprocedures of the preventive control. Records that may need to be included (depending on foodsafety plan) are supply-chain, the reasoning for not establishing a preventive control, calibration,Food Safety Checklist for Human Food3

V. 1.2; 12/19/2017 Copyright 2016-2020, Iowa State University of Science and Technology. All RightsReserved.and environmental monitoring. Records must be kept for the training of preventive controlqualified individual and qualified individuals.Comments:The food safety plan is the backbone for the application and documentation of Hazard Analysis and Risk BasedPreventive Controls in the plant. The preventive controls qualified individual must do or oversee preparation ofthe food safety plan. Remember the plan is dynamic. As your facility goes through everyday operations, theoptimization of processes, and additional products, check your plan to see what may need to be updated. This linkgives you access to a variety of resources that may be beneficial throughout this Definitions (§117.3):Facility means a domestic facility or a foreign facility that is required to register under section 415 of the Federal Food,Drug, and Cosmetic Act, in accordance with the requirements of part 1, subpart H of 21 CFR part 117.Food means food as defined in section 201(f) of the Federal Food, Drug, and Cosmetic Act and includes raw materialsand ingredients.Hazard means any biological, chemical (including radiological), or physical agent that has the potential to cause illnessor injury.Hazard requiring a preventive control means a known or reasonably foreseeable hazard for which a person knowledgeableabout the safe manufacturing, processing, packing, or holding of food would, based on the outcome of a hazard analysis (whichincludes an assessment of the severity of the illness or injury if the hazard were to occur and the probability that the hazard willoccur in the absence of preventive controls), establish one or more preventive controls to significantly minimize or prevent thehazard in a food and components to manage those controls (such as monitoring, corrections or corrective actions, verification,and records) as appropriate to the food, the facility, and the nature of the preventive control and its role in the facility's foodsafety system.Known or reasonably foreseeable hazard means a biological, chemical (including radiological), or physical hazard thatis known to be, or has the potential to be, associated with the facility or the food.Monitor means to conduct a planned sequence of observations or measurements to assess whether control measures areoperating as intended.Plant means the building or structure or parts thereof, used for or in connection with the manufacturing, processing,packing, or holding of human food.Preventive controls means those risk-based, reasonably appropriate procedures, practices, and processes that a personknowledgeable about the safe manufacturing, processing, packing, or holding of food would employ to significantlyminimize or prevent the hazards identified under the hazard analysis that are consistent with the current scientificunderstanding of safe food manufacturing, processing, packing, or holding at the time of the analysis.Preventive controls qualified individual means a qualified individual who has successfully completed training in thedevelopment and application of risk-based preventive controls at least equivalent to that received under a standardizedcurriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a foodsafety system.Significantly minimize means to reduce to an acceptable level, including to eliminate.Supply-chain-applied control means a preventive control for a hazard in a raw material or other ingredient when thehazard in the raw material or other ingredient is controlled before its receipt.Validation means obtaining and evaluating scientific and technical evidence that a control measure, combination ofcontrol measures, or the food safety plan as a whole, when properly implemented, is capable of effectively controllingthe identified hazards.Verification means the application of methods, procedures, tests and other evaluations, in addition to monitoring, todetermine whether a control measure or combination of control measures is or has been operating as intended and toestablish the validity of the food safety plan.Food Safety Checklist for Human Food4

V. 1.2; 12/19/2017 Copyright 2016-2020, Iowa State University of Science and Technology. All RightsReserved.Hazard Analysis and Risk-Based Preventive Controls Part 3 – §117.1303.13.23.33.43.53.63.7Hazard AnalysisYesNoN/ADocumentsDocumented assessment of biological, chemical,radiological, and physical hazards to determine whetherany hazards require a preventive control.Hint: Biological hazards include undesirable bacteria, fungi, parasites, and other pathogens.Chemical hazards include pesticide and drug residues, toxins, unapproved food or color additives,food allergens, and radiological hazards. Physical hazards include stones, glass, metal fragments,and other undesirable or unsafe physical objects in a food.Describe hazards known or reasonably likely to occur inthe food being processed in the facility in the hazardanalysis.Hint: These include natural, unintentionally introduced, or intentionally introduced hazards. This isbased on experience, illness data, scientific reports, and other information about food safety.Written evaluation of hazards (likelihood that the hazardwill occur in the absence of control(s) and the severity ofillness/injury caused by the hazard).Hint: This evaluation must include an evaluation of environmental pathogens whenever a ready-toeat food, such as cut fruit, is exposed to the environment prior to packaging and the packaged fooddoes not receive a treatment or other control measure to minimize the pathogen.The hazard evaluation must consider the safety of thefinished food for the intended consumer.Hint: Areas to focus on include but are not limited to: the formulation of the food, thecondition/function/design of the facility and equipment, raw materials and other ingredients,transportation practices, manufacturing/processing procedures, packaging activities and labelingactivities, storage and distribution, intended or reasonably foreseeable use (including age andhealth of intended consumer), sanitation of the facility, employee hygiene, and seasonal hazards.Document hazard evaluations of formulations,manufacturing and processing procedures, packagingactivities and labeling activities, and sanitation proceduresof the finished food.Hint: Determine if there are any biological, chemical, radiological, and physical hazards in theproduction of the food that can cause injury or illness to humans and animals.Written hazard evaluation of the condition, function, anddesign of the facility and equipment.Hint: Ensuring the production facility does not introduce, transfer, or promote (growth or survivalof) hazards requiring a preventive control into the production of the food.Written hazard evaluation of raw materials and otheringredients, transportation practices, storage anddistribution, and the intended and foreseeable use of theproduct.Hint: Minimizing the risks and effects of contamination of the product outside of facility. Also,understanding how the product will be used and how it can affect at-risk consumers. Describe howraw, rework, and finished items are kept separate and identified.Comments:The hazard analysis is about identifying all the points, from entering the processing facility to the end consumer,where a hazard requiring a preventive control is likely to occur. A hazard analysis should be conducted for eachdifferent process and product your facility has. However, if you have two products that have the same process,unless there are different health concerns, they can be grouped together.Food Safety Checklist for Human Food5

V. 1.2; 12/19/2017 Copyright 2016-2020, Iowa State University of Science and Technology. All RightsReserved.Definitions (§117.3):Environmental pathogen means a pathogen capable of surviving and persisting within the manufacturing, processing,packing, or holding environment such that food may be contaminated and may result in foodborne illness if that food isconsumed without treatment to significantly minimize the environmental pathogen. Examples of environmental pathogensfor the purposes of this part include Listeria monocytogenes and Salmonella spp. but do not include the spores ofpathogenic spore-forming bacteria.Facility means a domestic facility or a foreign facility that is required to register under section 415 of the Federal Food,Drug, and Cosmetic Act, in accordance with the requirements of part 1, subpart H of 21 CFR 117.Food means food as defined in section 201(f) of the Federal Food, Drug, and Cosmetic Act and includes raw materials andingredients.Food allergen means a major food allergen as defined in section 201(qq) of the Federal Food, Drug, and Cosmetic Act.Hazard means any biological, chemical (including radiological), or physical agent that has the potential to cause illness orinjury.Hazard requiring a preventive control means a known or reasonably foreseeable hazard for which a personknowledgeable about the safe manufacturing, processing, packing, or holding of food would, based on the outcome of ahazard analysis (which includes an assessment of the severity of the illness or injury if the hazard were to occur and theprobability that the hazard will occur in the absence of preventive controls), establish one or more preventive controls tosignificantly minimize or prevent the hazard in a food and components to manage those controls (such as monitoring,corrections or corrective actions, verification, and records) as appropriate to the food, the facility, and the nature of thepreventive control and its role in the facility's food safety system.Holding means storage of food and also includes activities performed incidental to storage of a food (e.g., activitiesperformed for the safe or effective storage of that food, such as fumigating food during storage, and drying/dehydratingraw agricultural commodities when the drying/dehydrating does not create a distinct commodity (such asdrying/dehydrating hay or alfalfa)). Holding also includes activities performed as a practical necessity for the distributionof that food (such as blending of the same raw agricultural commodity and breaking down pallets), but does not includeactivities that transform a raw agricultural commodity into a processed food as defined in section 201(gg) of the FederalFood, Drug, and Cosmetic Act. Holding facilities could include warehouses, cold storage facilities, storage silos, grainelevators, and liquid storage tanks.Known or reasonably foreseeable hazard means a biological, chemical (including radiological), or physical hazard that isknown to be, or has the potential to be, associated with the facility or the food.Manufacturing/processing means making food from one or more ingredients, or synthesizing, preparing, treating,modifying or manipulating food, including food crops or ingredients. Examples of manufacturing/processing activitiesinclude: Baking, boiling, bottling, canning, cooking, cooling, cutting, distilling, drying/dehydrating raw agriculturalcommodities to create a distinct commodity (such as drying/dehydrating grapes to produce raisins), evaporating,eviscerating, extracting juice, formulating, freezing, grinding, homogenizing, irradiating, labeling, milling, mixing,packaging (including modified atmosphere packaging), pasteurizing, peeling, rendering, treating to manipulate ripening,trimming, washing, or waxing. For farms and farm mixed-type facilities, manufacturing/processing does not includeactivities that are part of harvesting, packing, or holding.Mixed-type facility means an establishment that engages in both activities that are exempt from registration under section415 of the Federal Food, Drug, and Cosmetic Act and activities that require the establishment to be registered. An exampleof such a facility is a “farm mixed-type facility,” which is an establishment that is a farm, but also conducts activitiesoutside the farm definition that require the establishment to be registered.Monitor means to conduct a planned sequence of observations or measurements to assess whether control measures areoperating as intended.Packing means placing food into a container other than packaging the food and also includes repackingand activities performed incidental to packing or repacking a food (e.g., activities performed for the safe or effectivepacking or repacking of that food (such as sorting, culling, grading, and weighing or conveying incidental to packing orrepacking)), but does not include activities that transform a raw agricultural commodity into a processed food as defined insection 201(gg) of the Federal Food, Drug, and Cosmetic Act.Pathogen means a microorganism of public health significance.Preventive controls means those risk-based, reasonably appropriate procedures, practices, and processes that a personknowledgeable about the safe manufacturing, processing, packing, or holding of food would employ to significantlyminimize or prevent the hazards identified under the hazard analysis that are consistent with the current scientificunderstanding of safe food manufacturing, processing, packing, or holding at the time of the analysis.Food Safety Checklist for Human Food6

V. 1.2; 12/19/2017 Copyright 2016-2020, Iowa State University of Science and Technology. All RightsReserved.Raw agricultural commodity has the meaning given in section 201(r) of the Federal Food, Drug, and Cosmetic Act.Ready-to-eat food (RTE food) means any food that is normally eaten in its raw state or any other food, including aprocessed food, for which it is reasonably foreseeable that the food will be eaten without further processing that wouldsignificantly minimize biological hazards.Significantly minimize means to reduce to an acceptable level, including to eliminate.Verification means the application of methods, procedures, tests and other evaluations, in addition to monitoring, todetermine whether a control measure or combination of control measures is or has been operating as intended and toestablish the validity of the food safety plan.Food Safety Checklist for Human Food7

V. 1.2; 12/19/2017 Copyright 2016-2020, Iowa State University of Science and Technology. All RightsReserved.Hazard Analysis and Risk-Based Preventive Controls Part 4 – §117.1354.14.24.34.4Preventive Controls for HazardsYesNoN/ADocumentsIdentify and implement preventive controls for hazardsrequiring a preventive control to significantly minimize orprevent illness, injury, or death to a consumer of the food.Preventive controls are required for hazards at criticalcontrol points and other points that minimize or preventthese risks.Hint: The hazards requiring a preventive control were identified in Part 3 of this checklist.Preventive controls include any process controls, food allergen controls, sanitation controls,supply-chain-applied controls, the recall plan, certain good manufacturing practices, and any othercontrols appropriate for food safety.Process controls include procedures, practices, andprocesses to ensure the control of parameters duringoperations.Hint: Process controls may include heat, acidification, irradiation, and refrigeration. Minimum andmaximum values of parameters must be determined and must be based on scientific and technicalevidence.Food allergen controls include procedures, practices, andprocesses to control food allergens.Hint: These controls must include preventing allergen cross-contact through processing, storage,handling, and use, as appropriate, as well as proper labeling of potential allergens in finishedproducts.Sanitation controls include procedures, practices, andprocesses to ensure that the facility is maintained in asanitary condition to significantly minimize or preventhazards.Hint: Sanitation controls help prevent hazards requiring preventive controls due to employeehandling, food allergens, and environmental pathogens. These controls include proper cleaning offood-contact surfaces, utensils, and equipment as well as preventing any cross contamination frompersonnel, packaging, or other surfaces to food and raw product to finished product.Comments:Be sure to think past microbiological concerns and also think about physical and chemical hazards. Allergen controlis a large focus of FSMA. To control hazards, think about process, allergen, and sanitation controls.Definitions (§117.3):Acid foods/acidified foods/acidification means foods that have an equilibrium pH of 4.6 or below.Allergen cross-contact/contamination means the unintentional incorporation of a food allergen into a food.Food allergen means a major food allergen as defined in section 201(qq) of the Federal Food, Drug, and Cosmetic Act.Critical control point means a point, step, or procedure in a food process at which control can be applied and is essentialto prevent or eliminate a food safety hazard or reduce such hazard to an acceptable level.Environmental pathogen means a pathogen capable of surviving and persisting within the manufacturing, processing,packing, or holding environment such that food may be contaminated and may result in foodborne illness if that food isconsumed without treatment to significantly minimize the environmental pathogen. Examples of environmental pathogensfor the purposes of this part include Listeria monocytogenes and Salmonella spp. but do not include the spores ofpathogenic spore-forming bacteria.Facility means a domestic facility or a foreign facility that is required to register under section 415 of the Federal Food,Drug, and Cosmetic Act, in accordance with the requirements of part 1, subpart H of 21 CFR 117.Food means food as defined in section 201(f) of the Federal Food, Drug, and Cosmetic Act and includes raw materials andingredients.Food Safety Checklist for Human Food8

V. 1.2; 12/19/2017 Copyright 2016-2020, Iowa State University of Science and Technology. All RightsReserved.Food-contact surfaces are those surfaces that contact human food and those surfaces f

FSMA Human Food Audit Checklist Iowa State University Extension and Outreach Department of Food Science and Human Nutrition . The Food Safety Modernization Act (FSMA) was signed into law on January 4, 2011. FSMA is the largest change in food safety law since the Food, Drug, and Cosmetic Act was first passed in 1938.

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