Information
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Title
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Conducted on
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Prepared by
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Location
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Personnel
Summary of Results
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All questions responses, media, and follow-up actions have been entered and the audit/inspection is ready to be finalized.
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Results Summary
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Move the slider to the right until the overall score is reflected.
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A score below 80% is considered to be a failing score. A formal Corrective Action must be opened to address the overall deficiency in the facility GMP performance.
The Corrective Action should include some form of brainstorming and root cause analysis as to why the overall GMP program is performing below standard, should include a realistic follow-up plan, assignment of a responsible individual(s), and expected completion dates.
Upon completion of the corrective action a new complete GMP inspection should be performed to verify that the overall performance of GMP compliance has improved. -
Please enter the Corrective Action #:
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A score between 80 - 90% is considered to be a passing score that meets minimum expectations. A formal corrective action for the overall result is not required, however, individual deficiencies found during the inspection must be addressed through corrective measures and/or a formal corrective action. Corrections should be assigned to responsible individuals with expected completion dates. This should have been done during the course of the audit by utilizing the Create Follow-Up function from with in the auditing tool. Follow-Up actions should be monitored for timely closure and verified for effectiveness.
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Congratulations! A score of 90% or higher is consider to be superior performance. Please ensure that any necessary follow-ups are assigned and completed.
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Name and signature of auditor/inspector:
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Select date
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Name and signature of facility designated leadership representative:
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Select date
GMP Inspection Scorng Criteria
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There are two inspection sections with in the GMP inspection template:
Automatic Unsatisfactory Questions
There are questions that are aligned to the criteria for the Automatic Assessment of Unsatisfactory contained in The AIB International Consolidated Standards for Inspection - Beverage Facilities, (Copyright AIB International, 2008).
These questions are:
* Sequenced first in the GMP Inspection tool
* Mandatory to be completed
* Scored by a PASS or FAIL designation
* Worth 950 points each
A FAIL rating on any one of these questions is viewed as UNSATISFACTORY and will cause the overall rating for the entire inspection to be less than 80% which is UNSATISFACTORY. As such, each of these questions with a FAIL rating must have a Follow-Up action created within the tool that generally describes the follow-up needed, by when, and to whom the follow-up is assigned. Once, the Follow-Up actions are populated the inspection should be stopped and closed at this point. Failures in Automatic Unsatisfactory questions should take immediate and high priority for correction and generate a formal corrective action process.
Regular GMP Inspection Questions
The questions within this section are aligned to CCR Policy 00201, Good Manufacturing Practices. The purpose of Policy 00201 is to ensure regulatory compliance and consumer safety through adherence to Good Manufacturing Practices (GMPs), and to establish the minimum conditions for product storage, buildings and grounds, safety, security, equipment, housekeeping, and sanitation.
These questions are:
* Divided into eight categories
* They are not mandatory to be completed, however, a thorough inspection is recommended
* Are scored by a PASS or FAIL designation; FAIL designations should have Follow-Up actions
* Are worth 10, 20, 30, or 40 points; point values were established by CCR Corporate QA
When completing the inspection using a mobile device there is a series of three dots to right of each question. By touching these three dots the More Options box is opened. From this selection you can select Create Follow-Up (should be used for any Fail response) or Add Notes/Media (should be used to add comments for Pass responses and can be used to upload pictures directly from the mobile device to support either rating.)
GMP Inspection
Automatic Unsatisfactory Level Questions
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A FAIL response on any of the questions in this section is an indication that an UNSATISFACTORY rating would be assigned during the course of an AIB inspection. If any question in this section is scored with a FAIL response then the inspection should be stopped after the completion of this section and immediate corrective actions taken. FAIL responses require an immediate Follow Up item to be created and assigned for completion. A responsible person and a due date must be entered.
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Persons with visible boils, sores, or displaying signs of illness which may include: fever, nausea, vomiting, dizziness, coughing, sneezing and running nose must not be allowed to work In processing areas
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Follow-up action information entered. (To enter follow-up information click on the ... to the right of the inspection question.)
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Is there evidence of any one of the following within the facilities processing or storage areas: houseflies or fruit fly infestation? Any cockroach activity on or in a product zone? Visual presence of live rodents? Evidence of rodent excreta or gnaw marks on raw materials or finished products? Any decomposed rodent? Birds residing in processing areas or warehouses? Bird excreta present within the facility?
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Follow-up action information entered. (To enter follow-up information click on the ... to the right of the inspection question.)
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Is there evidence of maintenance activity or equipment condition resulting in oil, metal, or other foreign material in or over a product zone.
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Follow-up action information entered. (To enter follow-up information click on the ... to the right of the inspection question.)
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There are no non-approved pesticides (over the counter products for pests such as wasps, hornets, flies, ants, mosquitoes, etc., or commercial products supplied by a pest control operator) stored on the property. Approved pesticides are used consistently with label directions?
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Follow-up action information entered. (To enter follow-up information click on the ... to the right of the inspection question.)
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Equipment in processing areas must be free of peeling paint and rust (flaking paint, rust, or other materials in product zones).
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Follow-up action information entered. (To enter follow-up information click on the ... to the right of the inspection question.)
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Is there mold either on or near product zones (on fillers, cappers, syrup tanks, etc.)
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Follow-up action information entered. (To enter follow-up information click on the ... to the right of the inspection question.)
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Containers for finished products may only be used for their designated purposes. Beverage containers may not be used for storing chemicals, lubricants, pens, pencils, etc.
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Follow-up action information entered. (To enter follow-up information click on the ... to the right of the inspection question.)
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Spray balls inside tanks and other vessels must be free of debris that would prevent effective distribution of rinse water, cleaning solutions, and/or sanitizer solutions.
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Follow-up action information entered. (To enter follow-up information click on the ... to the right of the inspection question.)
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Product spillage must be cleaned immediately to prevent cross contamination and pest attraction. Evidence of spillage that is infested or has attracted pests or rodents shall result in zero points attained.
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Follow-up action information entered. (To enter follow-up information click on the ... to the right of the inspection question.)
Regular GMP Inspection Level Questions
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These questions are not mandatory to be completed and FAIL responses do not require immediate action. It is recommended however that all questions be answered during the inspection and that follow-up items be entered for any non-conformances.
General Requirements
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A Master Sanitation Schedule must be maintained and frequencies updated as required to adequately maintain the facility and equipment.
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All exterior doors, including bay and dock doors, must be kept closed or screened when not in use.
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All openings to the outside, including holes in walls and ceilings, must be closed to prevent the entry of rodents, birds, and insects.
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All doors to processing rooms (filler rooms, syrup mixing rooms, mineral blender rooms, water treatment rooms) must be closed and secured to prevent unauthorized access.
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All associates, visitors and contractors must comply with the GMP Policy. Observations of visitors and contracts during the inspection process shows that those individuals are in compliance with GMP requirements.
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All visitors and contractors must be required to sign in and out of the facility.
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Access to all processing areas, CO2 and sugar receiving must be restricted.
Personnel Practices
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All exposed cuts and grazes must be covered with a clean bandage.
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Personnel must wear suitable, clean clothing free from rips, tears or fraying material. Shirts must have sleeves and full length pants in all manufacturing areas. No buttons or pockets above the waist are allowed. No items may be carried behind the ear.
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Personnel in all manufacturing areas must wear effective head cover / hairnets. All hair must be contained in the hairnet.
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If worn, gloves must visibly clean and without damage to avoid product contamination (gloves must be no latex / no powder)
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Hearing protection must be tethered
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All employees, contractors and visitors must wear suitable footwear within processing and packaging areas. Shoes must be fully comply with the Company Safety Policy.
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While working in processing, packaging and warehousing areas all personnel must remove jewelry and cosmetic items such as: Visible or exposed piercings and body jewelry-Watches-Earrings-Necklaces-Bracelets-Rings -False fingernails (wear gloves does not except this requirement) -False eyelashes-Fingernail polish-Ear buds, earphones, blue-tooth devices (company issued devices for specific work tasks is excepted, i.e. voice pick headsets).
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All personal food and belongings must not be stored in manufacturing or warehouse and must be stored in designated areas, including, but is not limited to: Jackets, hats, pouches, medications, lunch bags, cell phones, ear-buds, etc.
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The use of tobacco products is prohibited except in designated outside locations
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Eating and drinking are allowed only in designated break areas (this includes but is not limited to, chewing gum, consumption of medication, etc.)
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Eating and drinking is not permitted in office spaces that open directly to a manufacturing and/or warehouse area
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Only taste-testing product for manufacturing purposes is allowed in the processing areas
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Only drinking water (for employee hydration purposes) in Company designated, closed containers are allowed in non-processing areas. Processing area exceptions must be approved by the RTM. The Container must be approved and company proprietary packages are not authorized.
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No drink coolers or food/beverage vending machines are allowed in manufacturing or warehouse areas
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Personnel must wash hands before beginning work, and after eating, drinking, smoking, using the restroom, or otherwise soiling hands. (Observe employees transitioning back to work form breaks).
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Personnel are required to practice good personal hygiene at all times. Spitting is prohibited and o Coughing and sneezing must be done into the elbow
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Personnel must have fingernails which are short, clean and without nail polish.
Buildings
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At a minimum, hand washing stations must be located in filling rooms, syrup rooms, restrooms, break rooms and repackaging areas.
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Restrooms must have functional exhaust fans that exhaust to the outdoors, must not open directly into manufacturing or warehouse areas.
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Food or drinks are not permitted in lockers or locker rooms
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Personnel lockers must be inspected and cleaned on a defined frequency (at a minimum yearly) per Facility Master Sanitation Schedule
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Restroom cleaning activities must be documented per the Facility Master Sanitation Requirements (at a minimum daily).
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Items are not to be stored on top of lockers
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Wall-floor junctions and corners are maintained to facilitate cleaning.
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Holes, cracks, and crevices in floor surfaces must be repaired to prevent debris from lodging and to avoid pest or microbial harborage.
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Drains are made of materials that are easily cleaned and kept in good repair.
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All drains, including trench trains, must be trapped and covered.
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Process drains are clean and in operable condition with no evidence of back-ups; covers must be easily removable for cleaning and inspection.
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Drains are functioning properly; no back-ups or odors indicative of improper function (traps have dried out, etc.). Evidence of appropriate documented actions exist if backup of sanitary drains occurs in manufacturing or warehouse areas to include: Cease Production, unblock / repair drain and clean and sanitize area and Food Safety Team must evaluate any potential risk of product or primary package contamination prior to resuming production.
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Sump pumps do not exist in the filling or syrup rooms.
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Holes, cracks, and crevices in walls surfaces must be repaired to prevent debris from lodging and to avoid pest or microbial harborage.
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Walls ceilings and overheads must be free of peeling paint, free of condensation and mold growth.
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All catwalks, stairs or walk-ways over conveyors of raw materials or product, must have catch pans underneath to prevent debris from falling on items below.
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Roofs must be self-draining and must not leak.
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Roof fans and vents must be insect screened (openings must be less than 1/20th of an inch).
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Skylights must be clean and in good repair.
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Break rooms must include: Designated and labeled hand wash sink, designated and labeled dish washing sink, an appropriate number of covered and labeled trash containers, adequate food storage for personnel.
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Break rooms are cleaned at a prescribed frequency and documented at a minimum: Tables, counters, refrigerators, microwaves floors, and fountain equipment.
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Vending machines need to be located either 18 inches from the wall or elevated at least four inches above the floor to allow for cleaning.
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Air return ducts for HVAC systems and air make-up units must be cleaned and inspected per Master Sanitation Schedule.
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The air handling units and filters must be clean and free of syrup, mold, and algae.
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Filling and syrup rooms must have adequate ventilation to ensure positive pressure.
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Hand washing stations must be clean and functional, including: Hot water at a minimum of 100F within 15 seconds, hands free operation in processing areas and restrooms, liquid soap with hands free dispensing, single use towels or air dryers are provided at hand washing stations, covered and labeled waste container at hand washing station when paper towels are used, all sinks must be properly plumbed and may not be discharged directly to the floor, hand washing stations must be labeled as “Hand Wash Only”
Cross Contamination
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Accumulation of waste shall not be allowed in food-handling or storage areas. Removal frequencies shall be managed to avoid accumulations, with a minimum daily removal.
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All waste or scrap compactors and containers are installed in a way that prevents product contamination: Containers are maintained to minimize and contain leakage, and are removable so the area can be cleaned; Containers must not be installed next to raw material or finished goods storage; Outside waste containers and compactors are closed or covered, and located in a manner to prevent pest attraction and harborage.
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Dumpster’s pulls must be emptied on a routine basis to prevent overflow.
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Grounds around dumpster must be kept clean, with no standing water, buildup of mold, or broken glass.
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Light bulbs, fixtures, windows, mirrors, skylights, and other glass suspended over product zones, product areas, ingredients, or packaging supplies are of the safety type or are otherwise protected to prevent breakage.
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There are no signs of out of control broken glass, brittle plastics, or ceramics.
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Light fixtures and glass must be replaced in a way that minimizes the potential for product contamination.
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Glass, brittle plastics, and ceramics that cannot be fully protected do not show signs of damage (cracks, chips, or missing pieces).
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The facility is in compliance to the brush and utensil program. Reference ETQ for US Region recommended policy.
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Utility knife snap-off blades are not used in production, packaging, or raw material storage areas.
Chemical Control
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All chemicals must be on the facility's approved chemical list and be properly labeled.
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Cleaning chemicals must not be stored on equipment or conveyors: If located in packaging or filling areas, must be in a locked/secured and designated storage cabinet.
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All cleaning chemicals must be stored in a locked area, away from production and food storage areas when chemicals are not in immediate use.
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Boiler chemicals must be either: Approved food additives which meet relevant additive specifications or additives which have been approved by the relevant regulatory authority as safe for use in water intended for human consumption.
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Boiler chemicals must be stored in a locked/secured area, away from production and food storage areas when chemicals are not in immediate use.
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Lubricants are labeled, segregated, and stored in a designated, secure area: Food- grade and non-food-grade lubricants are kept separate from each other.
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All coding ink and solvent, including those stored near the production line, must be stored in a locked fireproof cabinet.
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All chemicals, maintenance compounds and non-product materials, must be stored in a separate area.
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Only food-grade lubricants are used on food processing and packaging equipment or on any other equipment where incidental food contact may occur.
Grounds
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Facility boundaries (property perimeter) must be clearly identified and controlled to minimize pest attraction and harborage.<br>
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Buildings, landscaping and grounds must be in good repair, present no food safety hazard to the product and present a good image to the public. <br>
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An 18-inch perimeter around the outside walls must be maintained and kept clean. No storage is allowed within the perimeter.
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Outdoor equipment storage is minimal and should be no closer than 50 feet from the building. This includes but is not limited to shells, post mix containers, and pallets. Materials stored within 50 feet of the building must be maintained to minimize pest attraction and harborage.
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Equipment stored outside must prevent pest harborage, deterioration and contamination. Equipment must be inspected for pest harborage prior to being brought back into the building.
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Litter and waste must not be allowed to accumulate on the property.
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Weeds, tall grass, and vegetative growth must not be near the building or the fence line (within the control of the facility); existing landscaping near buildings must not show evidence of trending pest activity.
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Paved roads, yards and parking areas within the control of the facility must be maintained to be free of debris, standing water and other potential contaminants.
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Checker stations and guardhouses must be clean, and in good repair. The Guard Shack must meet the same housekeeping standards as the facility. The Food Safety Team must document if the Guard Shack is considered a designated Food Consumption area.
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All trailers must be closed when not being actively loaded to prevent pest entry.
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All trailers must be closed when not being actively loaded to prevent pest entry.
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Adequate drainage must be maintained for grounds and other areas.
Equipment
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Gasoline or diesel powered fork lift trucks are prohibited inside the facility.
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Pallet jacks, carts, trolleys, and forklifts, must be cleaned and well maintained.
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Fork lifts used for outside and/or recycling must not be used to in the processing and concentrate storage areas.
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Maintenance carts & tool boxes must be cleaned and well maintained. Carts must be free of personal belongings, (i.e. food medication, cellphones, etc.)
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Filler change parts, including but not limited to vent tubes, O-rings, snift-blocks, and CIP cups must be stored in a cleaned and sanitary manner.
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No eating or drinking is allowed on forklifts. Forklifts must be free of personal belongings, (i.e. food medication, cellphones, etc.)
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Food contact parts must be kept segregated from non-food contact parts. All food contact parts must be stored in a sanitary environment off the floor and equipment platforms.
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Food contact tools must be stored separately from non-food contact tools.
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Only clean and repaired food contact parts and equipment are stored in a designated parts storage area.
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All equipment and utensils are of a sanitary design and are easily cleaned and maintained. None are made of wood.
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Food contact surfaces must be corrosion-free, durable, and made of non-toxic materials.
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Seams on food contact surfaces must be smooth and free of spot or tack welds.
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Containers used to transport, process, hold or store raw materials, or finished products are constructed, handled and maintained in a way that prevents contamination.
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Empty concentrate containers must be defaced in a manner that makes the original container use unidentifiable.
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Secondary containers used to store ingredients must be legibly labeled with contents and lot code for traceability.
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Primary containers that contact the floor or other walking surfaces must be destroyed.
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Destroy all bottles that are handled by hand above the neck guide.
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After de-palletizing, empty bottles or cans must be filled or destroyed.
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Collection of containers in bags for reuse is not allowed.
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Full and partial closure boxes must be closed and sealed and stored in a clean and dry area.
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All cans, bottles, closures and lids must be removed from the line prior to cleaning and sanitizing. Empty bottles from de-palletizer to filler, closures from overhead track system and any open sleeves of lids must be removed.
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Conveyor covers must be in place from the de-palletizer/blow moulder through capping. Conveyor covers must be installed at a height that prevents foreign material contamination. Conveyor covers must be clean and free of contamination.
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Air intakes for air conveying equipment used to transfer bottles and closures must be protected to avoid inclusion of moisture and syrup residue in the air plenum.
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The facility must prevent, identify, and eliminate leaks (oil and lubricants) and excessive lubrication.
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Catch pans or deflector plates must be installed in areas where drive motors and gearboxes are mounted over product zones, and where conveyors cross or run parallel at different levels.
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The liquid strainers located in liquid ingredient receiving lines must not be torn (i.e. liquid sweetener receiving lines)
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Bulk liquid ingredient receiving lines must be used and stored in such a manner that the lines are off the floor/surface and that hose end connections cannot be submerged in liquids.
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Excessive accumulations of dirt, mold, and lubricants are prohibited on food contact surfaces, along or under conveyors or on guard rails.
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Excessive accumulations of dirt, mold, and lubricants are prohibited on non-food contact surfaces, along or under conveyors or on guard rails.
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Tape, string and cardboard (or any materials that can absorb water) are not to be used for temporary repairs.
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Any temporary repairs on food contact surfaces are constructed of food-grade material.
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Temporary repairs that effect food safety shall be given top priority to be permanently repaired.
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Wooden pallets and cardboard containers may not be stored/staged directly on filling room floors (i.e. totes with wooden pallets used for rejects, empty closure boxes and trash receptacles used to collect lid sleeves).
Storage Areas
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Inspection hatches are covered with screens when bulk materials are unloaded to eliminate the potential for foreign material contamination during the process.
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Outside receiving lines or caps to bulk dry and liquid ingredients are locked and identified, or otherwise secured
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Hoses used for loading, unloading, or in storage are on supports off the ground or floor to prevent contamination or submersion in water.
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Hoses, caps, and couplings are cleaned before storage in a secured area
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All sensitive areas must be locked. Only authorized personnel may have access. Sensitive areas include sweetener, syrup, concentrate storage, water treatment areas, all chemical storage rooms and beverage gas receiving areas.
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Adequate space is maintained between rows of stored raw materials, packaging, and finished products to allow inspection
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Raw materials, packaging and finished products are stored and removed from storage in a manner that prevents contamination. Raw materials are stored off the floor on pallets or stands. Raw materials: including coolers, packaging and finished products are stored at least 18 inches away from walls. If 18" of space is not feasible the material must be stored high enough off the floor to allow for inspections underneath.
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Storage areas are clean, well ventilated, and dry. Raw materials, packaging materials, and finished products are protected from condensate, sewage, dust, dirt, chemicals or other contaminants.
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Products containing allergens must be clearly identified and segregated to prevent cross contamination.
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Primary Containers are covered while in storage to protect against contamination from overhead structures. The top layer of all pallets (including partials) must be covered with a slip-sheet to prevent contamination. Partial pallets of PET bottles must be shrink wrapped prior to storage.
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Closures, crowns and lids must be stored to prevent cross contamination.
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Finished product must be clean, without accumulated dust, spillage, or damage.
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All leaking or damaged packages must be removed from storage rows immediately.
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Broken glass must be cleaned immediately to prevent foreign material contamination.
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Product must be protected from fixtures, chemicals, overhead conveyors, and any other substance or object that might contaminate contents or package appearance.
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Pallets and shells are in good condition and repair.
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When pallets and shells are stored outside, they are inspected for evidence of contamination and pest activity before being brought into the facility.
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There is a designated repackaging area maintained in a neat and orderly manner.
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Conforming and nonconforming products are clearly segregated.
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Allergen containing products and materials must be stored according to current company policy
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Repackaging is routinely processed to keep repackaged quantities at minimal levels
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Repackaging area must be cleaned daily to keep floors, work tables and sinks free from soil and product residue.
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Bulk systems and unloading areas are installed and maintained to prevent contamination (e.g. roof, covering, canopy, umbrella, inclement weather procedures, etc.)
