Title Page

  • Document No.

  • Audit Title

  • Client / Site

  • Conducted on

  • Add signature

  • Prepared by

  • Location
  • Personnel

Fundamentals

Employee Practices

  • 1. Are employees with: (a) Open and/or infected wounds or cuts on their hands or face, or with symptoms of infections illness prohibited from having direct contact with exposed product or production and/or storage areas? (b) Signs of communicable disease evaluated?<br>2. Are corrective actions taken if a worker is found to be infected?

  • Are employees maintaining (a) clean clothing or uniforms including outer garments? (b) Adequate personal cleanliness?

  • Are employees removing aprons, gloves, and other protective clothing (when in use) before leaving the product handling area?

  • Are employees prohibited from (a) wearing any jewelry other than a plain wedding band? (b) wearing false eyelashes or finger nails or finger nail polish (c) carrying loose items, such as pens or thermometers, in above-the-waist pockets?

  • Are employees washing and/or sanitizing hands and/or gloves prior to beginning or returning to work, or whenever the hands and/or gloves may have become soiled or contaminated?

  • Are employees maintaining gloves, if they are used in product handling in an intact, clean, and sanitary condition? Note: The gloves should be of an impermeable material.

  • Are employees prohibited from eating food, drinking beverages, spitting, chewing gum, and using tobacco and/or toothpicks in product handling areas? NOTE: Food consumption should also be prohibited in locker rooms.

  • Are all products, materials, and packaging that come in contact with blood destroyed, and any equipment, tools, and/or product contact surfaces that come in contact with blood cleaned and sanitized before use?

  • Does the operation have a written policy, which addresses applicable worker health and hygiene issues?

  • Are readily understandable written signs and/or pictures in appropriate language(s) strategically located around the product handling areas?

  • Are employees storing their clothing or personal belongings in appropriate designated areas away from the product handling areas?

Management Commitment and Review

  • Is a mission statement and product safety policy documented and communicated to all levels of the organization?

  • Is an organizational chart in place that identifies positions responsible for food safety system compliance including descriptions of responsibilities?

  • Is management following current GMPs (21 CFR 117)

Employee Practices

  • Are employees with:<br>a. open and/or infected woulds or cuts on their hands or face, or with symptoms of infections illness (e.g. diarrhea, vomiting), prohibted from having direct contact with exposed product or production and/or storage areas?<br>b. signs of communicable disease evaluated?

  • Are corrective actions taken if a worker is found to be infected?

  • Are employees maintaining:<br>a. clean clothing or uniforms including outer garments? (e.g. aprons, smocks, lab coats)<br>b. adequate personal cleanliness?

  • Are employees removing aprons, gloves, and other protective clothing (when in use) before leaving the product handling areas?

  • Are employees wearing hair restraints (e.g. hair nets, caps, headbands) and/or beard covers in an effective manner in product handling areas?

  • Are employees prohibited from:<br>a. wearing any jewelry other than a plain wedding band?<br>b. wearing false eyelashes or finger nails and finger nail polish?<br>c. carrying loose items, such as pens or thermometers, in above-the-waist pockets?

  • Are employees washing and/or sanitizing hands and/or gloves prior to beginning or returning to work, or whenever the hands and/or gloves may have been soiled or contaminated>

  • Are employees maintaining gloves, if they are used in product handling, in an intact, clean, and sanitary condition? NOTE: The gloves should be of an impermeable material.

  • Are employees prohibited from eating food, drinking beverages, spitting, chewing gum, and using tobacco and/or toothpicks in product handling areas? NOTE: food consumption should also be prohibited in locker rooms.

  • Are all products, materials, and packaging that come in contact with blood destroyed, and any equipment, tools, and/or product contact surfaces that come in contact with blood cleaned and sanitized before use?

  • Does the operation have a written policy, which addresses applicable worker health and hygiene issues?

  • Are readily understandable written signs and/or pictures in appropriate language(s) strategically located around the product handling areas?

  • Are employees storing their clothing or personal belongings in appropriate designated areas away from the product handling areas? NOTE: Food storage should be prohibited in lockers.

Training and Education

  • Is there a documented employee training program, which includes initial and ongoing and/or refresher food safety training for all employees, and training on cleaning and sanitation procedures for sanitation employees?

  • Is there an assigned person or an outside agency responsible for conducting training on topics such as food safety, GMPs, and sanitation and cleaning procedures?

  • Is there initial and ongoing and/or refresher employee training program that addresses food safety related issues to all employees including new employees?<br>Is the general content of the training sessions included?

  • Does the food safety, GMP training, and sanitation and cleaning procedures include evaluation criteria for knowledge learned?

  • Is worker participation in respective training programs documented, including the employee's signature and available for review?

  • Do employees appear to have received and understood training and are they practicing proper product handling procedures?

  • Is there a supervisor with relevant educational background and/or experience who oversees the food safety practices?

Toilet Facilities

  • Is a minimum of one toilet facility provided for every 20 people?<br>Are separate toilet facilities provided if there are 5 or more employees of each gender?<br>Are toilet facilities located with a 5-minute walk or 1/4 mile for all workers?

  • Are toilet facilities located and/or designed so as to reduce the possibility of contamination to water sources or product in the event of a malfunction?<br>Are doors to toilet facilities situated so they do not open into areas where product is exposed to air-borne contamination, except where alternate means have been taken to product against such contamination?

  • Do toilet facilities have:<br>a. self closing doors?<br>b. ventilation systems to eliminate odors?<br>c. Floors, walls, ceilings and toilets built in such a way that they can be cleaned and sanitized properly?<br>d. Floors, walls and ceilings in good repair?<br>e. Functional toilets and urinals?<br>f. Trash receptacles?

  • Are toilet facilities maintained in clean condition?

  • Are cleaning procedures described in a document that details how and when to clean (at least daily)?<br>Is cleaning documented and are records legible?

Hand washing facilities

  • Are hand washing stations provided next to the toilet facilities to facilitate their use?

  • Are additional hand washing stations and where appropriate hand sanitizer stations provided in the facility where good sanitary practices require employees to wash and/or sanitize their hands?

  • Are hand washing stations located and/or designed:<br>a. to prevent contamination of the product and to protect against recontamination of clean, sanitized hands?<br>b. to facilitate hands free operation?

  • Are single use paper towels or air drying devices used at hand washing stations?<br>Are hand washing stations functional and equipped with warm running water, bacteriostatic soap, and/or an appropriate hand sanitizer?<br>Are written signs and/or pictures in appropriate languages located next to the hand washing stations reminding employees to wash and sanitize their hands when necessary?

  • Are hand washing stations and/or hand sanitizing stations monitored and/or stocked throughout the day?<br>Is the chemical concentration in hand-dips maintained at appropriate concentration at all times, documented and available for review?

  • Are hand washing and/or hand sanitizing stations maintained in clean condition?<br>Are hand washing and/or hand sanitizing stations cleaned on a scheduled basis and as needed?

Water Sources

Water Source Testing

  • Is water with adequate quality provided in sufficient quantities and locations in the facility?<br>Are analytical tests for water kept on file><br>If results are out of specification, are corrective actions documented and legible?

In-house water testing

  • Is the water supply checked for microbial quality from several different locations in the facility?<br>Are analytical tests for water kept on file?<br>If results are out of specification, are corrective actions documented and legible?

  • Are drinking water supply delivery points, fountains, or containers maintained in a clean and sanitary manner, with single use paper cups provided where appropriate?

Grounds

  • Is there a written policy, which describes the required maintenance of grounds and is it being followed?<br>Are roads, yards, and parking lots maintained in a condition so that they do not constitute a source of contamination in areas where product is exposed?

  • Is 16-18 inches of clearance maintained around the outside perimeter of the building?

  • Is equipment and/or materials, which is stored on the grounds, stored in a manner so as to prevent harborage of pests?

  • Do all trash receptacles have closed lids?

  • Is litter collected and waste stored and/or disposed of in a manner adequate to minimize the odor, prevent contamination of product and/or become an attractant to vermin?

Building Size, Construction and Design

  • Is the facility constructed and/or designed so to allow complete separation of incoming, in-process, and finished products, to reduce potential for cross-contamination?

  • Are working spaces provided between equipment and walls, and are they adequately unobstructed and of adequate width to allow employees to perform their duties and to protect against contaminating product or product contact surfaces with clothing or personal contact?

  • Are employee break and/or locker areas separate from the product handling areas?

  • Is adequate lighting available in all areas where the product is manufactured, examined, packaged, or stored and in all employee areas?

  • Does the system for removing waste materials from product handling areas work efficiently?

Building Structures/Fixtures

  • Is the roof properly maintained?

  • Is the facility and its structures, such as ceilings, walls, floors, windows, vents, drains, and overheads designed and constructed of materials to be adequately cleaned and maintained in good repair, to protect product from cross-contamination?<br>Are these areas kept in good repair?

  • Are overhead fixtures, ducts, and pipes located over product contact surfaces, packaging materials, and exposed products, maintained in clean and good condition?

Plumbing

  • Is water used for cleaning of equipment, utensils, and for employee sanitary facilities maintained at a suitable pressure?

  • Are sewer pipes and water pipes placed to avoid possible contamination of product or equipment in the event of a leak or dripping from condensation, and are preventative measures in place?

  • Are the water lines for product handling and/or employee use protected against back-flow or cross connections from the waste water and sewage plumbing system?

  • Is there adequate floor drainage in areas where floors are subject to flood-type cleaning, or where normal operations release or discharge water or other liquid waste on the floor, and is there a procedure in place to remove discharge?

  • If potable and non-potable water is provided at the facility, is the water source and plumbing system identified potable vs. non-potable and are they separate?

Environmental Control

  • Is proper ventilation or control equipment in place to minimize odors?<br>If fans or other blowing equipment are used, are they operated in a manner that minimizes the potential for contaminating product, equipment, or packaging materials?

  • Are disinfectant foot foamers, foot baths, or foot sprayers provided at entries to product handling areas if appropriate?<br>Are sanitizer concentrations monitored regularly, documented, and available for review?<br>

Pest Control Program and Proedures

  • 1. Are pesticide applications performed by trained and licensed/certified personnel?<br>2. Are the service agreement, license and certificate of insurance current and available for review?<br>3. Does the facility have an assigned person responsible for overseeing the pest control program and is this responsibility documented?

  • 1. Do pesticides, chemicals, or other pest control measures meet applicable regulations?<br>2. Are MSDS and copies of labels for all chemicals and compounds used available for review?

  • 1. Are locations of all traps indicated on a facility map, which is cross referenced to a list or a key on the map showing the descriptions and/or types of traps at each station?<br>2. Is the facility map signed and dated within the last year?

  • Are pest control stations properly coded to correspond with the master identification map?

  • 1. Is there an adequate number of interior pest control devices, spaced at intervals along the interior perimeter of the facility, including on both interior sides of overhead doors?<br>2. Is there an adequate number of secured, tamper resistant exterior pest control devices, spaced at intervals around the building perimeter?<br>3. Are pest control stations set-up or constructed to avoid product, packaging, or equipment contamination?

  • Are live catch devices and glue boards checked at least bi-monthly, insect traps checked at least monthly, and bait stations checked for fresh bait at least monthly?

  • 1. Are pest control devices functioning properly?<br>2. Are pest control exclusion devices cleaned and maintained on a scheduled basis?

  • Is there no evidence of decomposed rodents in the interior or exterior pest control devices?

  • Does the inside of the facility appear to be free from insects, rodents, birds, and domestic animals?

  • Is there no evidence of insect, rodent, or bird activity on or in product, packaging, and product-contact surfaces?

  • 1. Are insect-exclusion devices used appropriately at exterior entrances?<br>2. Are insect exclusion devices cleaned and maintained on a scheduled basis?

  • Are all light traps positioned so that they will not attract insects from outside, into the building?

  • Are destructive type traps located at least 30 feet from exposed product or packaging and 5 feet away from covered product or packaging?

  • Are birds controlled by netting, screens, traps, or other exclusion methods?

  • Is toxic bait used only in exterior bait stations?

  • Are inspection records from the past twelve months available for review?

  • 1. Have cracks or crevices been sealed to prevent entrance or harborage of pests?<br>2

  • Are exterior doors and entrances closed when not in use?

  • If pest control chemicals are stored on site for pest control, are they properly labeled and kept in secure, locked areas, away from any product handling and packaging material storage areas?

Ice and Steam

  • 1. If ice is made in-house, is potable water used?<br>2. If steam comes in contact with product or product contact surfaces, is it generated from adequate microbial quality water?

  • Is ice in direct contact with product or product contact surfaces periodically checked for adequate microbial quality, and are results available for review?

  • In the event of adverse analytical findings, are corrective actions documented, legible and available for review?

  • Is ice handled or stored in a manner that prevents or minimizes the possibility of contamination?

Water

  • Is water that is used for conveyance, rinsing, or washing of adequate quality, and/or is it subjected to a treatment process adequate to ensure it is safe and of adequate sanitary quality?

  • Is concentration of antimicrobial chemicals and are parameters of the treatment process such as pH, temperature, specified in a written document, monitored adequately, documented, legible, and available for review?

Product Handling Practices

  • Are raw materials/ingredients stored or located in a place separate from in-process, work in progress (WIP), rework, and finished products to prevent cross-contamination?

  • 1. Are raw materials and other ingredients purchased under supplier's guarantee or certification?<br>2. Is a letter of guarantee or certificate of analysis kept on file and available for review?

  • Are first-in/first-out (FIFO) rotation practices used and documented for all raw materials/ingredients?

  • Are containers, totes, and other equipment used to hold incoming products, in-process, rework or finished products appropriate for use, properly labeled and/or colored coded and covered appropriately?

  • 1. Does the facility prohibit the reuse of:<br>a. in house containers for holding products, unless they are adequately sanitized or have protective liners?<br>b. ingredient containers for holding products or ingredients, unless they are adequately sanitized or have protective liners?<br>2. Are singe-use containers for microbiologically sensitive products prohibited from reuse?

  • Are raw materials and other ingredients pasteurized or otherwise treated during manufacturing operations so that they no longer contain levels of microorganisms that would cause the product to be adulterated?

  • 1. Is thawing of frozen materials performed under controlled conditions and monitored to ensure proper temperature controls are maintained?<br>2. Are thawing procedures and verification checks of compliance documented and available for review?

  • Are manufacturing mechanical steps performed to protect product against contamination; this may be accomplished by adequate physical protection of product from contaminants that may drip, drain, o r be drawn into product?

  • Are physical factors such as time, temperature, humidity and manufacturing operations such as freezing and refrigeration carefully monitored to ensure that mechanical breakdown, time delays, temperature fluctuations, and other factors do not contribute to the decomposition or contamination of product?

  • 1. Are raw materials/ingredients, which are rejected or on hold, properly identified, adequately segregated, stored under appropriate conditions and disposed of appropriately if not used?<br>2. Are findings from receiving inspections and corrective actions documented and are these documents available for review?

  • Is work in progress (WIP) and/or rework conducted? If yes, does the facility have policies and procedures that address the:<br>a. use of materials intended for WIP and/or rework?<br>b. storage conditions of rework materials?<br>c. identifications and coding of materials intended for rework?<br>

  • Does the facility have procedures that address percent of rework that can be added back to the regular formula?

  • Does the facility maintain batch formulation records that identify the addition of rework product?

  • Does the facility enforce periodic breaks in rework cycle?

  • Are products inspected for evidence of contamination prior to packaging?

  • Are adulterated products disposed of in a manner that protects against the contamination of other foods?

  • Are first-in/first-out FIFO rotation practices followed for finished products?

Microbiological Testing

  • Does the facility have a microbiological testing program for raw materials, finished products, and/or work in progress?

  • Does the microbiological testing program include:<br>a. acceptance limits/standards used to determine product acceptability?<br>b. actions to be taken when out-of-standard results are found for ingredients or products?

  • Does the microbiological testing program document corrective actions when out-of-standard results are found for ingredients or products?

Hold & Release Program

  • Is there a documented hold and release program that includes:<br>a. who is responsible for putting items on hold and releasing them?<br>b. how products are marked and controled?<br>c. how "hold" product is monitored, how often it is reconciled and by whom?

  • Are non-conforming products, which are rejected or on hold, properly identified, adequately segregated, and controlled against inadvertent shipment, and protected from contamination?

Packaging Materials

  • 1. Are packaging material storage areas maintained under conditions that prevent or minimize the likelihood of contamination?<br>2. Are restricted chemicals that are used in processing or as an ingredient, stored in secure, locked areas away from food and packaging supplies?

  • 1. Is a sanitation program in place for the packaging materials storage area, and is the area cleaned on a regular basis and inspected from a sanitation standpoint?<br>2. Are the areas monitored for pest activities on a continuous basis?

  • Is FIFO practiced?

  • Are packaging materials inspected for evidence of contamination prior to use?

  • During production, are packaging materials handled in a manner that eliminates contamination from the ground or from inappropriate employee handling?

  • Are damaged cases or packages segregated immediately and products repacked or properly disposed of?

  • Are packaging materials used only for their intended purpose and not used to store other things?

Foreign Material Control & Calibration

Foreign Material Control

  • Are foreign material detectors used on the packing lines? If yes, are they inspected on a routine basis to ensure proper performance and are inspection records maintained and available for review?

  • 1. Is there a documented glass and/or brittle plastic management policy?<br>2. Does it include procedures for: <br>a. line stoppage? <br>b. segregation of suspect materials?<br>c. clean-up?<br>d. re-inspection?

  • Is exposed glass and/or brittle plastic prohibited, and is a highly audited "glass free zone" maintained in the product handling and storage areas?

  • Is the packaging material made of glass? If so, are proper control measures in place to prevent breakage, and is there a written policy for handling glass packaging in product storage and handling areas?

  • 1. Is compressed air used to clean product contact surfaces or equipment, handled in such a way as not to contaminate the products with unlawful indirect product additives?<br>2. Is compressed air such as oxygen, nitrogen, and carbon dioxide used in modified atmospheric packaging, filtered?

  • 1. Are food grade lubricants approved for use in appropriate areas and are they properly stored?<br>2. Are MSDS and labels maintained on file?<br>3. Are excess grease and lubricants removed from the equipment located over or close to product contact surfaces?

Calibration

  • Are temperature measuring devices and other monitoring equipment, including foreign material detectors, calibrated on a specified schedule and are records available for review?

Recall/Traceability

  • Is there a formal, written Product Recall Program that includes:<br>a. a recall coordinator<br>b. a 24 hour recall team contact list<br>c. a description of categories<br>d. regulatory contacts and procedures to notify regulatory agency?

  • Is there a product coding system that can identify products and can the system track finished products back to the their source?

  • Are mock recalls for lot code backwards and lot code forward performed at least annually and are results documented and maintained on file?

  • In the event of an actual recall, is the associated documentation available for review?

  • 1. Is a food-safety-related customer complaint program in place?<br>2. Are records of food-safety-related customer complaints and company responses kept on file and available for review?

Facility Inspection

  • Are good manufacturing practices or facility inspections conducted periodically, and are findings, corrective actions, and follow ups documented and available for review?

  • Are regulatory inspection procedures documented and are inspection records available for review?

  • Are reviews of the written product safety management plan and associated procedures conducted periodically and are periodic reviews documented and available for review?

Access Control

  • Are truck drivers restricted from production and warehouse areas?

  • Is facility access limited to authorized personnel?

  • 1. Is there a policy requiring inspectors, visitors, and contractors to comply with good manufacturing practices?<br>2. Are they required to read or are they briefed on GMPs policy upon entry to the facility?

Equipment and Chemicals

  • 1. Are cleaning compounds and sanitizing agents appropriate for product and non-product contact surfaces?<br>2. Are SDS and copies of specimen labels maintained for cleaning and sanitizing chemicals?<br>

  • Are cleaning compounds and sanitizing agents used by the sanitation crew or for production clearly identified with chemical name, when in original container and when not in original container?

  • 1. Are cleaning compounds and sanitizing agents stored in secure locked areas away from product handling or storage areas?<br>2. Do chemical storage areas have clean floors?

  • Are first in first out (FIFO) rotation practices used for all cleaning and sanitizing chemicals?

  • 1. Are containers, brushes, and applicators, which are used for cleaning and/or sanitizing, color coded or labeled to properly identify them for their intended use?<br>2. If a color coding system is used, is appropriate signage posted regarding use of the containers and equipment?

Cleaning, Sanitation and Housekeeping Procedures

  • 1. Is there a written sanitation program that describes how sanitation in and around the facility is managed, who is responsible for managing it, and policies related to sanitation?<br>2. Are the cleaning procedures described in a document that details frequency of cleaning, types of cleaning chemicals used, cleaning items used, and how and when to clean?

  • 1.Are non-product contact surfaces and areas throughout the facility, including dry and cold storage areas, cleaned on a scheduled basis and as needed?<br>2. Is cleaning documented, reviewed, and are records legible and available for review?<br>

  • 1. Are product contact equipment and surfaces throughout the day cleaned on a scheduled basis, or as needed?<br>2. Is cleaning documented, reviewed, and are records legible and available for review?

  • Are pre-operative inspections conducted and documented, and are records legible and available for review?

  • 1. Is environmental and equipment sampling performed on a periodic basis to monitor the effectiveness of cleaning and sanitizing procedures and are results maintained on file?<br>2. Is air quality monitored on a scheduled basis to ensure that it is of suitable quality?

  • Does the environmental testing program document corrective actions in response to isolated positive results?

The templates available in our Public Library have been created by our customers and employees to help get you started using SafetyCulture's solutions. The templates are intended to be used as hypothetical examples only and should not be used as a substitute for professional advice. You should seek your own professional advice to determine if the use of a template is permissible in your workplace or jurisdiction. You should independently determine whether the template is suitable for your circumstances.