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PNW GMP Checklist (Module 5)
PNW GMP Checklist (Module 5)
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PNW GMP Checklist (Module 5)

Good Manufacturing Practices Requirements Compliance

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Free PNW GMP Checklist (Module 5) Checklist

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Title Page

  • Client / Site

  • Date

  • Prepared by

  • Location

  • INSTRUCTIONS

    1. Please answer the questions below.
    2. Add Photos in ""Images"" and Comments in ""Notes"" on each question.
    3. Add a Corrective Measure in ""Action."" Provide a description, assign to a member, set priority, and due date
    4. Complete the audit by providing a digital signature
    5. Share your report by exporting as PDF, Word, Excel or Web Link.

GENERAL GMP

  • 5.01.01 Is there a designated person responsible for the operation’s food safety program?

  • 5.01.02 Are all cleaning and maintenance chemicals (pesticides, sanitizers, detergents, lubricants,etc.) stored securely, safely and are they labeled correctly?

  • 5.01.03 Are “food grade” and “non-food grade” chemicals used appropriately, according to the label and stored in a controlled manner?

  • 5.01.04 Are signs supporting GMPs posted appropriately?

  • 5.01.05 Are the necessary food defense controls implemented in the operation?

PEST CONTROL

  • 5.02.01 Are products or ingredients free of insects/rodents/birds/reptiles/mammals or any evidence of them?

  • 5.02.02 Are packaging supplies free of insects/rodents/birds/reptiles/mammals or any evidence of them?

  • 5.02.03 Are plant and storage areas free of insects/rodents/birds/reptiles/mammals, or any evidence of them?

  • 5.02.04 Is the area outside the facility free of evidence of pest activity?

  • 5.02.05 Is there an effective pest control program in place?

  • 5.02.06 Are pest control devices located away from exposed raw materials, work-in-progress,ingredients (including water and ice), finished goods and packaging, and poisonous rodent bait traps are not used within the facility?

  • 5.02.07 Are pest control devices maintained in a clean and intact condition and marked as monitored (or bar code scanned) on a regular basis?

  • 5.02.08 Are interior and exterior building perimeter pest control devices adequate in number and location?

  • 5.02.09 Are all pest control devices identified by a number or other code (e.g. barcode)?

  • 5.02.10 Are all pest control devices effective and bait traps secured?

STORAGE AREAS AND PACKAGING MATERIALS

  • 5.03.01 Does the facility layout ensure separation of ingredients (including ice), products,and packaging stored to prevent cross contamination (this includes iced product pallets stored above pallets of product without adequate protection as well as any allergen cross contamination issues)?

  • 5.03.02 Is the storage area completely enclosed?

  • 5.03.03 Is the facility’s use restricted to the storage of food products?

  • 5.03.04 Are rejected or on hold materials clearly identified and separated from other materials?

  • 5.03.05 Are raw products, work in progress,ingredients (including water and ice), finished goods and food contact packaging within accepted tolerances for spoilage and free from adulteration?

  • 5.03.06 Are all storage areas clean, especially the racking structures, lights, ceilings, floor areas by the walls and other hard to reach areas?

  • 5.03.07 Are materials (commodities, packaging,ingredients, processing aids, work in progress,etc.) properly marked with rotation codes (receipt dates, manufacture dates, etc.)?

  • 5.03.08 Are materials (commodities, packaging,ingredients, processing aids, work in progress,etc.) rotated using FIFO policy?

  • 5.03.09 Are storage areas at the appropriate temperatures for the specific products being stored?

OPERATIONAL PRACTICES

  • 5.04.01 Does the process flow, facility layout, worker control, utensil control, internal vehicle use,etc. ensure that finished (processed) products are not contaminated by raw (unprocessed) products?

  • 5.04.02 Are all exposed materials (product, packaging,etc.) protected from overhead contamination (e.g. ladders, motors, condensation, lubricants, walkways, loose panels, degrading insulation, etc.)?

  • 5.04.03 Are production areas completely enclosed?

  • 5.04.04 Are production areas clean and well maintained; especially lights, ducts, fans, floor areas by the walls and equipment, and other hard to reach areas?

  • 5.04.05 Is all re-work / re-packaging handled correctly?

  • 5.04.06 Are raw ingredients examined before use?

  • 5.04.07 Are finished products coded (carton and unit packaging) for the day of production?

  • 5.04.08 Are foreign material control methods (e.g.metal detectors, metal traps, magnets, visual inspection, x-ray machines, etc.) in place and regularly tested (where relevant) to ensure proper operation?

  • 5.04.09 Does the facility use the appropriate test strips, test kits or test probes for verifying the concentrations of anti-microbial chemicals(product contact water, terminal sanitizers,dip stations, etc.) being used, are they in operational condition and are they being used correctly?

  • 5.04.10 Are hand washing stations adequate in number and appropriately located for worker access and monitoring usage?

  • 5.04.11 Are hand washing stations in working order, have water of suitable temperature and pressure, adequately stocked (e.g. disposable towels, unscented soap, etc.) and restricted to hand washing purposes only?

  • 5.04.12 Are toilet facilities adequate in number and location and are they adequately stocked (e.g. toilet paper, disposable towels, unscented soap, etc.)?

  • 5.04.13 Are secondary hand sanitation stations (e.g.,touch-free dispensers) adequate in number and location, and are the stations maintained properly?

  • 5.04.14 Are foot baths, foamers or dry powdered sanitizing stations adequate in number and location, and are the stations maintained properly?

  • 5.04.15 Are single service containers used for their intended purpose only so that potential cross contamination is prevented

  • 5.04.16 Are re-usable containers cleanable or used with a liner and clearly designated for the specific purpose (trash, raw product, finished product, re-work, ice, etc.) such that cross contamination is prevented?

  • 5.04.17 Are devices used to measure, regulate or control temperature, pH, acidity, water activity, and other conditions that affect food safety, working properly and adequately maintained?

WORKER PRACTICES

  • 5.05.01 Are workers washing and sanitizing their hands before starting work each day, after using the restroom, after breaks, before putting on gloves and whenever hands may be contaminated?

  • 5.05.02 Are workers’ fingernails clean, short and free of nail polish?

  • 5.05.03 Is there no sign of any worker with boils,sores, open wounds or exhibiting signs of foodborne illness working directly or indirectly with food?

  • 5.05.04 Are workers wearing effective hair nets that contain all hair?

  • 5.05.05 Is jewelry confined to a plain wedding band and watches are not worn?

  • 5.05.06 Are all workers wearing outer garments suitable for the operation (e.g., appropriate clothes, smocks, aprons, sleeves, non-latex gloves?

  • 5.05.07 Do workers remove protective outer garments (e.g., smocks, aprons, sleeves, and gloves) when on break, before using the toilets and when going home at the end of their shift?

  • 5.05.08 Is there a designated area for workers to leave protective outer garments (e.g., smocks,aprons, sleeves, and gloves) when on break and before using the toilets?

  • 5.05.09 Worker personal items are not being stored in the production or material storage area(s)?

  • 5.05.10 Is smoking, eating, chewing and drinking confined to designated areas, and spitting is prohibited in all areas?

  • 5.05.11 Is fresh potable drinking water readily accessible to workers?

  • 5.05.12 Are all items removed from garment (shirt,blouse, etc.) top pockets, and unsecured items are not worn (e.g., pens, glasses on top of head, Bluetooth devices, etc.)?

  • 5.05.13 Are workers issued non-reproducible identification (e.g., badges, company ID cards,etc.)?

  • 5.05.14 Are first aid kits adequately stocked and readily available in the facility, and are blue band aids used?

EQUIPMENT

  • 5.06.01 Are food contact equipment surfaces free of flaking paint, corrosion, rust and other unhygienic materials (e.g., tape, string,cardboard, etc.)?

  • 5.06.02 Are non-food contact equipment surfaces free of flaking paint, corrosion, rust and other unhygienic materials (e.g., tape, string,cardboard, etc.)?

  • 5.06.03 Does food contact equipment design,placement, and condition (e.g., smooth surfaces, smooth weld seams, non-toxic materials, corrosion-resistant, no wood or other absorbent materials) facilitate effective cleaning and maintenance?

  • 5.06.04 Are thermometers (independent of thermostat probes) present in all coolers and freezers?

  • 5.06.05 Are all thermometers non-glass and nonmercury?

EQUIPMENT CLEANING

  • 5.07.01 Are food contact equipment surfaces clean?

  • 5.07.02 Are non-food contact equipment surfaces clean?

  • 5.07.03 Are items (totes, bins, etc.) that are used to hold or store product clean?

  • 5.07.04 During cleaning, are food products and packaging materials protected from contamination?

  • 5.07.05 Are cooling units, including coils in coolers and freezers, clean and free of aged, dirty ice?

  • 5.07.06 Are all fan guards dust-free and the ceiling in front of the fans free of excessive black deposits?

  • 5.07.07 Is stored equipment that is not used on a daily basis stored in a clean condition with food-contact surfaces protected and/or are they retained on cleaning schedules in some manner, even though they are not in use?

  • 5.07.08 Are all utensils, hoses, and other items not being used, stored clean and in a manner to prevent contamination?

  • 5.07.09 Are maintenance tools that are used in the production and storage areas of the facility clean, sanitary and corrosion free?

  • 5.07.10 Are excess lubricants and grease removed from the equipment and are lubricant catch pans fitted where needed?

GENERAL CLEANING

  • 5.08.01 Are spills cleaned up immediately?

  • 5.08.02 Are waste and garbage frequently removed from production and storage areas?

  • 5.08.03 Do floor drains flow in a manner that prevents contamination (e.g., from high to low risk areas, from high risk directly to drain system),are they covered, appear clean, free fromodors and are well maintained?

  • 5.08.04 Do high level areas, including overhead pipes,ducts, fans, etc., appear clean?

  • 5.08.05 Are plastic strip curtains maintained in good condition, kept clean and mounted so that the tips are not touching the floor?

  • 5.08.06 Does personal protection equipment (PPE) for the sanitation crew meet label requirements of chemicals used, and is it in good condition and stored to prevent cross contamination to raw products, work in progress, ingredients,finished goods or packaging?

  • 5.08.07 Is cleaning equipment maintained clean and stored properly?

  • 5.08.08 Is cleaning equipment identified in order to prevent potential cross contamination issues (e.g., production, maintenance, outside, restroom equipment)?

  • 5.08.09 Are all items used for sanitation appropriate for their designated purpose (e.g., no steel wool, metal bristles, etc.)?

  • 5.08.10 Are toilet facilities and hand washing stations clean?

  • 5.08.11 Are worker break facilities clean, including microwaves and refrigerators, and no rotting or out of date foodstuffs?

  • 5.08.12 Is the maintenance shop organized, with equipment and spares stored in a neat and tidy fashion?

  • 5.08.13 Are internal transport vehicles (e.g., forklifts,bobcats, pallet jacks, carts, floor cleaners,etc.), clean, do not emit toxic fumes and are being used in a sanitary manner?

  • 5.08.14 Are shipping trucks clean and in good condition?

SITE

  • 5.09.01 Is there a site plan showing the facility location, adjacent sites, roads, water sources,storm water, waste water and other relevant features?

  • 5.09.02 Is there a facility floor plan showing the layout of the building, production areas, storage areas, water sources and fixtures, layout of equipment and traffic flow patterns?

BUILDINGS AND GROUNDS

  • 5.10.01 Are all lights in the facility that could potentially contaminate raw materials, work in progress, ingredients (including ice), finished goods, equipment or packaging shielded, coated or otherwise shatter resistant to protect product from contamination in the event of breakage?

  • 5.10.02 Has the operation eliminated or adequately controlled any potential metal, glass or hard plastic contamination issues?

  • 5.10.03 Has the facility eliminated the use of wooden items or surfaces?

  • 5.10.04 Is there adequate lighting in the production and storage areas?

  • 5.10.05 Is ventilation adequate to control dust,condensation, odors and vapors?

  • 5.10.06 Are floor surfaces in good condition, with no standing water, no debris trapping cracks and are they easy to clean?

  • 5.10.07 Are the floor drains where they are needed for drainage and cleanup?

  • 5.10.08 Are all entry points to the production and storage areas protected to prevent entry of rodents and birds?

  • 5.10.09 Are dock doors fitted with buffers/shelters to seal against trucks in temperature controlled environments?

  • 5.10.10 Are dock load levelers and buffers/shelters maintained in good condition, pest proof and debris free?

  • 5.10.11 Are exterior walls free of holes to exclude pests, and are pipes, vents, and air ducts designed and protected in order to prevent pest entry (e.g., by using fine mesh)?

  • 5.10.12 Are interior walls and ceilings free of cracks and crevices to prevent pest harborage and allow proper sanitation?

  • 5.10.13 Is an 18” (46 cm) internal wall perimeter being maintained within the facility, with adequate access to these wall perimeters, thereby allowing inspection and cleaning?

  • 5.10.14 Is the exterior area immediately outside the facility, including roads, yards and parking areas, free of litter, weeds and standing water?

  • 5.10.15 Are control measures being implemented for the outside storage of equipment, pallets,tires, etc. (i.e. out of the mud, pipe ends capped, stacked to prevent pest harborage, away from the building perimeter)?

  • 5.10.16 Are pallets inspected to separate and replace dirty or broken pallets, and broken or dirty pallets are not in use?

  • 5.10.17 Is the area around the dumpster/cull truck/trash area clean?

  • 5.10.18 Are outside garbage receptacles and dumpsters kept covered or closed?

  • 5.10.19 Are all water lines protected against back siphonage?

  • 5.10.20 Is the on-site laboratory completely enclosed and separated from production and storage areas?

CHEMICAL FILES

  • 5.11.01 Are copies of all Safety Data Sheets (detergents, sanitizers, pesticides, etc.) on file and fully accessible at all times with clear indexes?

  • 5.11.02 Are there copies of specimen labels for chemicals used, where the full label is not immediately accessible (e.g., rodent chemicals, product sanitizers)?

  • 5.11.03 Are there chemical inventory logs for chemicals, including pesticides, fertilizers and cleaning and sanitizing chemicals?

  • 5.11.04 Are there specific Standard Operating Procedures (SOPs) for the monitoring/testing and changing of recirculated and batch water systems (e.g., dump tanks, flumes,hydrovacuums, hydrocoolers, etc.) and testing of single pass water systems?

PEST CONTROL DOCUMENTATION

  • 5.12.01 Is there a documented pest control program,detailing the scope of the program, target pests and frequency of checks, including a copy of the contract with the extermination company (if used), Pest Control Operator license(s)/training (if baits are used), and insurance documents?

  • 5.12.02 Is there a schematic drawing/plan of the facility showing numbered locations of all pest monitoring devices (e.g., rodent traps,bait stations, insect light traps, etc.) both inside and outside the facility?

  • 5.12.03 Are service reports created for pest control checks detailing inspection records, application records, and corrective actions of issues noted (in-house and/or contract)?

OPERATION MONITORING RECORDS

  • 5.13.01 Are there inspection records for incoming goods (e.g., raw materials, ingredients and packing materials)?

  • 5.13.02 Are there inspection logs on incoming trailers (and other forms of transport) for rodents and insects, cleanliness, holes and temperature control of the trailer (for food requiring temperature control for safety and/or as required per buyer specifications)?

  • 5.13.03 Are there records for the necessary process monitoring activities (e.g., pH, water temperature vs. product temperature, metal detection, X-ray, labeling, heating processes, reduction/kill step processes, postharvest pesticides, waxing, control of water activity, drying, etc.), showing, for example, monitoring frequencies, results and where necessary the corrective actions?

  • 5.13.04 Are there records (with corrective actions) that show anti-microbial (e.g., free chlorine, ORP,peroxyacetic acid) strength testing of product contact water and ice solutions prior to start up and throughout the production runs?

  • 5.13.05 Are there records of visual monitoring and/or testing and changing of recirculated and batch water systems (e.g., dump tanks, flumes,hydrovacuums, hydrocoolers, etc.), for build-up of organic material (turbidity)?

  • 5.13.06 Are there records (with corrective actions) that show anti-microbial strength testing of hand/foot/tool dip stations, and are there stock check and replenishment records for gel and spray stations?

  • 5.13.07 Is there a tool accountability program for knives and similar cutting hand tools used in the production area?

  • 5.13.08 Is there a pre-operation inspection log?

  • 5.13.09 Has a documented risk assessment been performed to ensure that any food safety hazards relevant to facility location and adjacent land use are identified and controlled?.

  • 5.13.10 Is there a current certificate of inspection (or similar record) for backflow prevention assemblies on water lines into the facility?

  • 5.13.11 Is there documented evidence of the internal audits performed, detailing findings and corrective actions?

MAINTENANCE AND SANITATION FILES

  • 5.14.01 Does the facility have a preventative maintenance program and a documented schedule?

  • 5.14.02 Are there logs of maintenance work and repairs and are they signed off when work is completed?

  • 5.14.03 Are there logs showing that equipment is properly cleaned and sanitized after maintenance and repair work has been completed?

  • 5.14.04 Is there a written cleaning schedule (Master Sanitation Schedule) that shows what and where is to be cleaned and how often?

  • 5.14.05 Are there written cleaning and sanitation procedures (Sanitation Standard Operating Procedures) for the facility and all equipment?

  • 5.14.06 Are cleaning and sanitation logs on file that show what was done, when and by who?

  • 5.14.07 Are there records showing verification of cleaning and sanitizing chemical concentrations?

  • 5.14.08 Are there documented procedures and completion records for clean-in-place (CIP) activities (e.g., cleaning re-circulating water systems such as washing flumes, ice injectors, hydrocoolers, ice makers, etc.), where applicable?

  • 5.14.09 Is there a routine program and written procedure to verify sanitation effectiveness using rapid post sanitation checks (e.g., ATP measurements, allergen specific proteins)?

  • 5.14.10 Are there sanitation logs on file indicating that floor drains are cleaned on a regular basis (minimum daily in wet and fresh-cut production areas)?

  • 5.14.11 Are there records showing filters in air conditioning, ventilation and air filtration units are regularly cleaned and replaced?

  • 5.14.12 Are there records showing cooling units are maintenance serviced and cleaned at least every 12 months or more frequently as required?

  • 5.14.13 Is there a documented glass and brittle plastic management procedure (including company glass and brittle plastic policy, glass breakage procedure and where necessary a glass register)?.

WORKER DOCUMENTATION

  • 5.15.01 Are there records of new worker food safety (GMP) orientation training (with topics covered and attendees) and are all workers required to sign the company’s food safety hygiene and health policy?

  • 5.15.02 Are there logs of ongoing worker food safety education training, including topics covered, attendees, etc.?

  • 5.15.03 Is there a documented training program with training logs for the sanitation workers,including best practices and chemical use details?

  • 5.15.04 Are there written and communicated procedures in place that require food handlers to report any cuts or grazes and/or if they are suffering any illnesses that might be a contamination risk to the products being produced, and return to work requirements? (In countries with health privacy/ confidentiality laws, e.g. USA, auditors can check procedure/policy but not the actual records).

  • 5.15.05 Are there worker food safety non-conformance records and associated corrective actions (including retraining records)?

  • 5.15.06 Are visitors and contractors required to sign a log stating that they will comply with the operations’ personal hygiene and health requirements?

TESTING

  • 5.16.01 Is there a written risk-based, scientifically valid microbiological testing program that may include pathogen testing, and details program design (zonal approach, food contact/non-food contact surfaces, spent sprout irrigation water, test & hold, water, ice, etc.), rationale for organisms tested for, procedures for sampling and testing (surfaces, water, product, ingredients, etc.), timing and frequency of testing, the testing methodology, the lab that performs the tests, and acceptable results/threshold levels for each organism?

  • 5.16.02 Are there records of environmental microbiological test results and does testing meet the program requirements?

  • 5.16.03 Are there records of microbiological tests on water used in the facility (sampled from within the facility) and does the testing meet the program requirements?

  • 5.16.04 Are there records of microbiological tests on ice used in the facility (either produced in-house or purchased) and does testing meet the program requirements?

  • 5.16.05 Are there records of tests performed on compressed air or other mechanically introduced gases that is used directly on food and food contact surfaces and does testing meet the program requirements?

  • 5.16.06 Are there records of other tests (e.g., spent sprout irrigation water, product, raw ingredients, etc.) that are performed for any reason (e.g., customer requirements, best practice, regulatory requirements) and does testing meet program requirements?

  • 5.16.07 Are there written risk-based corrective action procedures for when unacceptable test results are received, that describe the steps to be taken, assign responsibility for taking those steps, and steps to ensure the cause is identified (e.g., root cause analysis) and corrected to minimize the potential for product contamination?

  • 5.16.08 Are there records of corrective actions taken after unsuitable testing results that describe the steps taken, responsibility for taking those steps, and actions taken to ensure that the cause of contamination has been identified and corrected?

  • 5.16.09 Where food safety related testing is being done in-house, is there a laboratory quality assurance manual with validated testing methods and protocols, evidence of training related to sample collection and testing protocols, and relevant records of results?

TEMPERATURE CONTROLLED STORAGE AND DISTRIBUTION LOGS

  • 5.17.01 Are there records of final product temperature checks for temperature sensitive product?

  • 5.17.02 Are there temperature logs for the production area (if refrigerated)?

  • 5.17.03 Are there temperature logs for storage rooms?

  • 5.17.04 Is there a documented procedure for checking truck trailer temperature prior to shipping?

  • 5.17.05 Are there records of shipping truck trailer (or other transportation systems) temperature checks, indicating the truck trailer temperature settings and that the truck trailer was pre-cooled prior to loading?

  • 5.17.06 Is there a documented procedure for reviewing the sanitary condition of truck trailers that will transport the product?

  • 5.17.07 Are there sanitary condition logs for shipping truck trailers (or other transportation systems)?

ALLERGEN CONTROL

  • 5.18.01 Are there no allergen risks handled or stored within production and storage areas?

  • 5.18.02 Has a documented allergen management plan been developed?

  • 5.18.03 Are there adequate storage controls (e.g.,separation, identification, etc.) that ensure that allergens are not contaminating other materials?

  • 5.18.04 Is there a dedicated allergen production line or adequate clean down and production procedures that prevent allergen cross contamination?

  • 5.18.05 Are utensils and work in progress storage containers identified in order to prevent allergen cross contamination?

  • 5.18.06 Does re-work handling take into account the issues associated with allergen containing products?

  • 5.18.07 Are workers trained with respect to allergen risks and the facility allergen cross contamination controls (including hand washing between production runs) and are there records of this allergen training?

  • 5.18.08 Are worker practices adequate and being followed to protect against allergen crosscontact and against contamination of food?

  • 5.18.09 Are all products manufactured on site labeled correctly with respect to allergens?

Sign Off

  • Prepared by (Full Name and Signature)

PNW GMP Checklist (Module 5)
Anonymous

PNW GMP Checklist (Module 5)

Good Manufacturing Practices Requirements Compliance

Use this Template
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.

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