CCR US Region GMP Inspection

Information

Audit Title
Client / Site
Conducted on
Prepared by
Personnel
Location

1. Operational Methods and Personnel Practices

Rejection of Shipments/Receipt of Dry Goods A facility can safeguard its food products by identifying and barring entry or shipment of potentially contaminated raw materials or finished products.

Damaged, infested, or dirty transports/containers are rejected.
The facility maintains documentation of rejected shipments that includes the reasons for rejection.

Storage Practices Finished products are stored in a way to meet Program requirements for safe storage of materials.

Adequate space is maintained between rows of finished products to allow cleaning and inspection. Procedures are followed to guarantee the proper cleaning, inspection, and monitoring for pest activity in storage areas, where an 18 in. or 45 cm inspection perimeter cannot be provided. If an 18 in. or 45 cm clearance from walls is impossible due to aisle widths and forklift turning space, a rack system can be installed against the wall. In this case, a bottom rail is installed 18 in. or 45 cm off the floor so that no pallets are stored on the floor.
Dates to facilitate stock rotation are visible on the pallet or individual container and are on a permanent part of the packaging (e.g., not on the stretch wrap).
Materials shipped in damaged, infested, or dirty vehicles are rejected.
There are at least 14 in. or 35 cm of space between pallet rows.
Storage slots and traffic lanes are provided for items stored at floor level.

Finished Product Inventory Finished product inventories are maintained at reasonable volumes to avoid excessive age and insect infestation.

Finished products and other materials are rotated on a First- In, First-Out (FIFO) basis or other verifiable method (such as First Expired, First Out [FEFO]) to ensure stock rotation.
Insect-susceptible materials in storage longer than four weeks are regularly inspected. A system is defined and followed for identifying and tracking of inspection of insect-susceptible materials (e.g., aged stock inventory, re-palletizing dates, etc.).

Pallets Clean and well-maintained pallets minimize opportunities for contamination.

Pallets are clean and in good repair. When pallets are stored outside, they are inspected for evidence of contamination before being brought into the facility for use.

Designated Rework Areas Rework or salvage, if not segregated and managed properly, can cause contamination of packaging or finished product.

There is a designated repackaging area that is segregated from usable materials.
Repackaged finished product date coding is maintained for traceability purposes.
Rework is processed weekly or often enough to keep rework quantities at minimal levels.

Cross Contamination Prevention Incompatible or hazardous materials require separate handling to prevent contamination.

Measures are taken to prevent cross contamination by hazardous ingredients, such as allergens in storage areas.
Allergen containing finished products returned from customers are segregated from non-allergen containing products returned from customers. Allergen containing products that have leaking containers are discarded. Non-allergen containing products that have come into contact with leakage from allergen containing products are discarded.

Finished Product Transportation Finished product is coded for traceability, and shipping requirements are in place to prevent product contamination.

Distribution records identify the initial point of distribution as per regulatory requirements.
Local delivery trucks and route trucks are inspected and cleaned at least weekly to identify potential sources of foreign material contamination.

Hand Washing Facilities Personnel are provided the equipment to effectively remove contamination from their hands.

Suitable and properly maintained hand washing facilities are located in all restrooms/locker rooms, break-rooms, repackaging areas, and as appropriate at the entrances to warehousing areas of the facility. Single-use towels or air dryers are provided at hand washing stations. Hand washing faucets must supply hot water at a minimum of 100F within 20 seconds. “Wash hands” signs appear above sinks and entries to production areas, where appropriate.
Waste containers for disposable paper towels are covered.
Finished products are handled and transported in a way that prevents actual or potential contamination. Finished products are loaded or transferred in covered bays or canopies to protect the products from weather damage. Staging and loading of perishable materials does not pose a food safety risk.
Prior to loading, all shipping vehicles are inspected for cleanliness and structural defects that could jeopardize the product. Shipping vehicle inspections are documented. Interior light bulbs in finished product transports are shielded or coated to prevent breakage. No odors or other contaminants are present in transports. Transport vehicles have not hauled garbage/waste or nonfood items that may cause product contamination.

Washrooms, Showers, and Locker Rooms Cleanliness diminishes chances of contamination being spread from personnel areas.

All washrooms, showers, and locker rooms are maintained in a sanitary condition. No pests or mold are present. There are no open food or drinks in lockers or locker rooms. “Wash hands” signs are displayed in all restrooms, lunchrooms, smoking areas, and appear above sinks and entries to production areas where appropriate.
Company-owned personnel lockers are inspected on a defined frequency.

Personal Hygiene Personnel conform to hygiene practices to avoid becoming a source of contamination.

Trained supervisors are responsible for ensuring that all personnel are complying with facility policies regarding personnel practices.
Personnel wash hands before beginning work, and after eating, drinking, smoking, using the restroom, or otherwise soiling hands. Personnel are encouraged to practice good personal hygiene at all times. Hand washing practices are checked periodically for effectiveness (e.g., visual inspection, swabbing, observation, etc.).

Personal Items and Jewelry Control Personal items and jewelry present product contamination risks if not controlled.

Personnel eat, drink, chew gum, and use tobacco products only in designated areas.
All personal property is stored in a designated area.
Personal food and belongings are not brought into production or storage areas.

Health Conditions Facility policies are in place and enforced to prevent disease, illness, or infection from contaminating product.

(AU) No person with boils, sores, infected wounds, or any other infections or communicable disease is permitted to contact food as defined by regulations.
All personnel health cards are current and properly posted if required by local regulations.
The facility follows procedures requiring personnel, including temporary workers, to notify supervisory personnel of any relevant infectious disease or conditions to which they may have been exposed.

Non-Facility Personnel Visitors and contractors are required to comply with facility policies to protect product from contamination.

Non-facility personnel conform to the facility Personnel Practices Program. Non-facility personnel include, but are not limited to: Visitors, Temporary personnel, Regulatory authorities, Outside contractors, Tour groups, and Family and friends of personnel.
Where appropriate, visitors and contractors undergo medical screening and appropriate training before entering storage areas.
The facility follows procedures requiring personnel, including temporary workers, to notify supervisory personnel of any relevant infectious disease or conditions to which they may have been exposed.

Waste Material Disposal Waste materials and their removal are managed to avoid contamination.

Waste containers are emptied at least daily, more frequently if required to prevent an accumulation or overflow of waste from containers.
Trash or inedible waste is stored in properly covered, labeled containers. Trash or inedible waste does not come in contact with raw materials, work-in-process, or finished product at any time.
Licensed contractors remove waste, where required.
Waste and recycle material containers are legibly labeled with contents and are covered. Containers that are in use do not have to be covered.
Waste disposal meets regulatory requirements.

2 Maintenance for Food Safety

Facility Location Selection and management of the facility location will allow personnel to identify and control potentially negative impacts of surrounding operations.

The facility identifies and takes measures to prevent product contamination from local activities that could have adverse impacts.
Facility boundaries are clearly defined and controlled.
Effective measures are in place to prevent product contamination from neighboring properties. These measures are periodically reviewed.

Outside Grounds and Roof The facility grounds are maintained in a way that prevents food adulteration.

Equipment stored outside is placed to prevent pest harborage, to make the inspection process easier, and to protect equipment from deterioration and contamination. Outdoor equipment storage is minimal.
Litter and waste are removed from the property. Litter is not allowed to accumulate on the property.
Weeds and tall grass are not near the building. Landscaping is maintained such that shrubs, bushes, trees, etc. are not next to buildings or overgrown in such a manner as to create pest harborages.
Roads, yards, and parking areas are maintained to be free of dust, standing water, and other potential contaminants.
Adequate drainage is provided for grounds, roofs, and other areas.
Waste containers and compactors are closed or covered, and located on a concrete pad or in a manner to minimize pest attraction and harborage.
Truck bays and garage areas are maintained to prevent pest attraction or harborage.
Waste containers and compactors are closed or covered, and located on a concrete pad or in a manner to minimize pest attraction and harborage.

Layout Spacious layout and placement of equipment, materials, and structures facilitates inspection, cleaning, and maintenance activities.

Space is maintained between equipment and structures to enable cleaning and maintenance. There is adequate space to place equipment and raw materials

Floors The floors of the facility are designed and maintained to provide structural integrity, facilitate cleaning, prevent contamination, and eliminate pest harborage or entry.

Floors are made of materials that are easily cleaned and kept in good repair. Floors are designed to meet the demands of facility operations and withstand cleaning materials and methods. Floors are impervious.
Floors are sloped to direct the flow of water or effluent toward drains.
Wall/floor junctions and corners are maintained to facilitate cleaning. Holes, cracks, and crevices in floor surfaces are repaired to prevent debris from lodging and to avoid pest or microbial harborage.

Drains The drains in the facility are designed and maintained to provide structural integrity, facilitate cleaning, prevent contamination, and eliminate pest harborage or entry.

Drains are made of materials that are easily cleaned and kept in good repair.
Floor drains with grates are installed, maintained, and operational in all wet processing or wash areas. Floor drain grates are easily removable for cleaning and inspection.
Drainage is designed and maintained to minimize the risk of product contamination.

Walls The walls of the facility are designed and maintained to provide structural integrity, facilitate cleaning, prevent contamination, and eliminate pest harborage or entry.

Walls are made of materials that are easily cleaned and kept in good repair. Holes, cracks, and crevices in wall surfaces are repaired to prevent debris from lodging and to avoid pest or microbial harborage. Walls are designed, constructed, finished, and maintained to: Prevent dirt accumulation, Reduce condensation and mold growth, Facilitate cleaning

Ceilings and Overhead Structures Structural elements such as ceilings, beams, supports, fixtures, ducts, pipes, or equipment do not threaten food product with leaking, loose, chipping, flaking, or peeling material.

Ceilings are made of materials that are easily cleaned and kept in good repair. Access to the void in hollow or suspended ceilings is provided to facilitate cleaning, maintenance, and inspection activities. Ceilings and overheads are designed, constructed, finished, and maintained to: Prevent dirt accumulation, Reduce condensation and mold growth, Facilitate cleaning.
Roof leaks are promptly identified, controlled, and repaired.
Fixtures, ducts, pipes, and overhead structures are installed and maintained so that drips and condensation do not contaminate finished products.
Drips and condensation are controlled to prevent establishment of an environment suitable for microbial growth.
There is no flaking paint or rust on equipment or overhead structures. Only normal mild oxidation on nonfood contact surfaces is acceptable.
Other materials (such as loose insulation) do not threaten food products.

Glass, Brittle Plastics, and Ceramics Control The Glass, Brittle Plastics, and Ceramics Program manages not only lighting to ensure that it is adequate for the safe production of food products, but the Program also takes into consideration breakable materials that are used for other purposes within the facility.

Adequate lighting is provided in all areas.
Light fittings and glass are replaced in a way that minimizes the potential for product contamination.
Glass that cannot be fully protected is addressed in the Glass, Brittle Plastics, and Ceramics Program.

Air Makeup Units Air used in the facility is filtered or screened, and filters and screens are maintained to prevent product contamination.

Air makeup units are fitted with clean filters and are free of mold and algae. Air return ducts for HVAC systems and air makeup units are fitted with cleaning and inspection hatches.
Fans, blowers, filters, cabinets, and plenums are on the Preventive Maintenance Schedule to prevent mold, the development of microbes, insect activity, and foreign material collection.
Air blowing equipment is located, cleaned, and operated in a way that does not contaminate finished products.
Filters are capable of removing particles of 50 microns (Minimum Efficiency Reporting Value [MERV] 4) or larger.
Ventilation is provided in product storage and processing areas to minimize odors, fumes, and vapors.
All light bulbs, fixtures, windows, mirrors, skylights and other glass used in storage areas where there is no product exposure are protected against breakage unless managed under the Glass, Brittle Plastics, and Ceramics Program.

Pest Prevention The materials, structure, and maintenance of the building and equipment support the Integrated Pest Management Program.

The building has barriers in place to protect against birds, rodents, insects, and other pests.
External doors, windows, or other openings are close-fitting or otherwise pest-proofed to less than ¼ in. or 6 mm.
Windows, doors, and skylights that must be kept open for ventilation are screened to prevent pest entry.

Cross Contamination Prevention Different steps in the production of food products can negatively impact processing in other areas. Segregation of operations minimizes opportunities for food hazards to arise.

Operations are separated based on process flow, material types, equipment, personnel, airflow, air quality, and services needed. The process flow, from receiving to shipping, is arranged to prevent product contamination. Areas for washing and cleaning are located away from production activities, where appropriate.
Toilet rooms are provided with functional exhaust fans that exhaust to the outdoors or do not open directly into production, packaging, or raw material storage areas.
Water installations and equipment are constructed and maintained to prevent back siphonage and backflow.
The sewage disposal system is adequate for the process and maintained to prevent direct or indirect product contamination.

Equipment and Utensil Construction Equipment and utensils designed for easy maintenance ensure compliance with Prerequisite and Food Safety Programs. Surfaces that deteriorate, or cannot be cleaned or maintained, may present product contamination hazards.

All equipment and utensils are designed and made of materials that are easily cleaned and maintained.

Temporary Repair Materials Temporary repairs are sometimes needed or unavoidable. Procedures to ensure that they do not become a contamination hazard are defined.

Tape, wire, string, cardboard, plastic, and other temporary materials are not used for permanent repairs. If used for emergency repairs, they are dated and replaced with a permanent repair as soon as possible. The facility maintains a record of work orders or repair requests. The facility follows temporary repair procedures. Temporary repair issues are resolved as soon as possible and practical.

Hand Washing Facilities Design Personnel are provided the equipment to effectively remove contaminants from their hands.

Hot and cold running water is provided in all washrooms, hand sinks, and locker rooms. Hand washing facilities have an adequate water supply.
Hand washing facilities are labeled and separated from utensil washing facilities.

Facility Location Selection and management of the facility location will allow personnel to identify and control potentially negative impacts of surrounding operations.

Physical security measures that require maintenance or design can include: Perimeter fences, Surveillance cameras, Locked doors, Security guard stations, Controlled access, Controlled bulk storage areas

3. Cleaning Practices

Cleaning Cleaning is more than making the facility look good. Cleaning methods and scheduling take food safety into account.

A Master Sanitation Schedule / Master Cleaning must be maintained and frequencies updated as required to adequately maintain the facility and equipment.
Cleaning is done in a way that prevents contamination of raw materials, products, and equipment.

Support Area Cleaning Cleaning support areas eliminates product residues that may allow insect development, mold, or other contaminants that could affect the product or impact production.

Daily cleaning tasks are completed in a way that prevents contamination. Daily cleaning tasks are assigned to the appropriate department. Daily cleaning tasks ensure that work and support areas remain clean during working hours.
Support areas that may impact equipment or storage of finished products (e.g., washrooms, maintenance shops, tray wash areas, etc.) are cleaned to prevent product contamination or insect development.
Non-sealed electrical panels and boxes located in areas that are susceptible to insect development are cleaned and inspected every four weeks.
Areas used for the storage of equipment, finished products, or utensils are cleaned and maintained to prevent contamination of product or equipment.
Dock leveler pits are cleaned frequently enough to prevent excessive accumulation of debris, product spillage, or other materials.
Racks and storage shelves are cleaned frequently enough to prevent excessive accumulation of debris, product spillage, or other materials.
Drains are routinely cleaned and sanitized to prevent microbial and pest development.
Racks and storage shelves are cleaned frequently enough to prevent excessive accumulation of debris, product spillage, or other materials.

Equipment and Tools Cleaning equipment and tools may have a negative impact on food safety if not managed properly.

Cleaning equipment and tools are available for use. Cleaning equipment is maintained and stored in a way that does not contaminate foods or food contact equipment.
Separate and distinct utensils are used to clean different zones (allergen zones, storage zones, etc.). Utensils used to clean restrooms or floor drains are never used for any other cleaning purpose. A color-code or other type of classification is in place to identify and separate cleaning utensils based on their intended usage. The facility is in compliance to the brush and utensil program.
All cleaning utensils are cleaned and properly stored after use. Proper storage includes segregation to ensure that cross contamination does not occur.
Forklifts, pallet jacks, and similar equipment are cleaned and the cleaning is tracked on the Master Cleaning Schedule or Preventive Maintenance Schedule.

4. Integrated Pest Management

Integrated Pest Management (IPM) Program A written IPM Program ensures the facility has effective controls and processes in place to minimize pest activity.

The facility has a written Integrated Pest Management Program. The IPM Program incorporates the requirements of the facility’s other written Prerequisite and Food Safety Programs. The IPM Program is written and implemented by trained in-house personnel, or by registered, trained, or licensed contractors.
If the IPM Program development and implementation is outsourced to contractors, the Program includes responsibilities for both in-house personnel and contractors.

Facility Assessment An annual assessment of the facility provides an evaluation of the IPM Program to ensure that it is effective.

Personnel conduct an annual assessment of the facility. The assessment evaluates all areas inside and outside the facility. Assessments are conducted by internal or external trained IPM personnel.
Assessment results and Corrective Actions are documented and used to develop and update the IPM Program.

Other Guidelines Facilities that use alternative guidelines (such as organic, green, or sustainable) are also held accountable for having IPM Programs.

IPM Programs established under alternative guidelines (such as organic, green, or sustainable) demonstrate effective pest management through the lack of evidence of pest management issues, and by meeting the criteria in the IPM section of this Standard.

Signed Contracts A signed contract between the facility and external IPM providers holds both the provider and the facility accountable for effective pest management activities.

The facility has a signed contract that includes: Facility name, Facility contact person, Frequency of services, Description of contracted services and how they will be completed, Term of the contract, Equipment and material storage specifications, where applicable, List of approved chemicals, prior to use, Emergency call procedures (when, why, whom to call), Service records to be maintained, Requirement to notify facility of any changes in service or materials used

Pesticide Documentation The facility maintains current pesticide label and Chemical Safety Data Sheet information to ensure proper usage of pesticide chemicals.

Chemical Safety Data Sheets or equivalent are on file for all pesticides used in the facility by in-house personnel or contractors. Documentation is available for review on request as hard copy or electronic files. Pesticide Specimen Labels are on file for all pesticides used in the facility. Documentation is available for review on request as hard copy or electronic files. The language of the country is taken into consideration when providing Chemical Safety Data Sheets and labels.

Pesticide Application Documentation The facility maintains records to identify, verify, and document compliance to regulatory and IPM requirements.

Documented pesticide application activities include: Product name of materials applied, The EPA, PMRA, or product registration number as required by law, Target pest, Rate of application or percent of concentration, Specific location of application, Method of application, Amount of pesticide used at the application site, Date and time of application, Signature of applicator
The facility keeps a record of additional information that may be required by regulation, including lot number of product used and the applicator’s certification or registration number.

Pesticide Application Documentation The facility maintains records to identify, verify, and document compliance to regulatory and IPM requirements.

Documented pesticide application activities include: Product name of materials applied, The EPA, PMRA, or product registration number as required by law, Target pest, Rate of application or percent of concentration, Specific location of application, Method of application, Amount of pesticide used at the application site, Date and time of application, Signature of applicator
The facility keeps a record of additional information that may be required by regulation, including lot number of product used and the applicator’s certification or registration number.

Pesticide Control Pesticides are managed as part of the Chemical Control Program.

Does the facility store pesticides on site?
Pesticides are stored in a limited access, locked area. Storage areas are adequate in size and construction, and are properly ventilated. Pesticides are stored according to label directions.
Pesticide containers and application equipment are labeled to identify contents. Application equipment is not used across multiple pesticides.
Pesticide containers are disposed of according to label directions and regulatory requirements.
Warning signs are posted at the entrance of each pesticide storage area.
The facility maintains a complete inventory of pesticides.
Spill control materials and procedures are available.

Monitoring Device Documentation Monitoring device documentation is maintained to ensure that devices are properly placed and inspected, and to allow trend analysis of activity.

A detailed survey of the entire facility is completed, and the results are documented and used to determine placement of monitoring devices.
A current and accurate site map that lists the locations of all pest-monitoring devices used in rodent and insect control is on file.
Temporary placement of any pest monitoring devices for short-term monitoring is mapped separately. Findings are documented according to the frequency defined by the IPM Program.
The facility records all services performed on all pest-monitoring devices.
Services for monitoring devices are documented with recording mechanisms, such as punch cards, bar codes, or ledgers, and may be maintained in hard copy or electronic format.
Service records in monitoring devices match documentation on file in the facility.

Exterior Rodent Monitoring Devices Management of exterior rodent monitoring devices deters rodents from entering the facility.

Based on the detailed facility survey, exterior monitoring devices are placed along the foundation walls on the exterior of the facility.
All exterior monitoring devices are inspected at least monthly. These devices are checked more often when activity levels increase.
Exterior bait stations that contain rodenticides are locked with single-use plastic ties, padlocks, or devices provided by the manufacturer, such as key systems.
Exterior bait stations are tamper resistant and are positioned, anchored in place, locked, and labeled.
Only baits that are approved by the regulatory body with authority for IPM (e.g., EPA in the United States) or that are labeled for use in a food facility are used in exterior bait stations.
Baits are secured inside bait stations, in good condition, and replaced as needed based on the label directions or manufacturer recommendation to avoid deterioration.
Monitoring devices are placed at intervals of 50-100 ft. or 15-30 m. Areas of high rodent activity should have a higher concentration of devices.

Interior Rodent Monitoring Devices Interior rodent monitoring devices identify and capture rodents that gain access to the facility.

Based on the detailed facility survey, interior monitoring devices are placed in sensitive areas specific to the rodent species, and other areas of pest activity, including: Incoming materials warehouses or primary storage areas for raw materials, Maintenance areas with exterior access, Staging areas where materials are placed after delivery from the warehouse, Finished product warehouse areas, Areas with the potential for rodent access due to traffic patterns or activities that take place, Overhead areas when roof rat activity is evident or likely, High traffic areas, Both sides of doors that open to the exterior of the facility
Interior monitoring devices are placed along perimeter walls. Spacing and number of traps are based on activity levels.
Toxic and non-toxic commercial baits (blocks, liquids, etc.) are not used for interior monitoring.
Interior monitoring devices are positioned, cleaned, and inspected weekly.
Unless prohibited by regulation, interior monitoring devices include: Mechanical traps, Extended trigger traps, Glue boards
Monitoring devices are placed at intervals of 20-40 ft. or 6-12 m along exterior walls, and are strategically placed in sensitive areas toward the interior of the facility.

Insect Light Traps When used, insect light traps assist in the identification and monitoring of flying insects.

Insect light traps are used to monitor flying insect activity at locations that are likely to allow access to the facility.
Does the facility use insect light traps?
Insect light traps are installed farther than 10 ft. or 3 m from exposed products, packaging, and finished product storage areas.
Insect light traps are installed in a way that does not attract insects to the facility.
Service checks are performed on all units on a weekly basis during the active season and a monthly basis during colder seasons or as dictated by climate. These checks include: Emptying collection devices, Cleaning the units, Repairs, and Checks for tube breakage.
Shatter-resistant lights are used in all units or otherwise explained in the facility’s Glass, Brittle Plastics, and Ceramics Program.
All services provided to light traps are documented. Service records are kept in the device and on file with the pest management documentation.
The facility documents the types and quantities of insects found in the light traps, and uses the information to identify and eliminate the source of activity. This can include, but is not limited to identifying insect types (e.g., night-flying insects, flies, stored product insects, etc.) and quantities captured (specific or relative numbers [i.e., high, medium, low]) to evaluate the risks and determine appropriate control measures to be taken.
Insect light trap tubes are changed at least annually at the beginning of the active season.

Trend Analysis Documentation of pest sightings and activity are reviewed and used to identify and eliminate areas where pest activity is observed, and to document Corrective Actions taken.

Accurate and complete service records describe current levels of pest activity and recommendations for additional Corrective Actions.
The pest-sighting log provides information about the response taken by pest management personnel.
All records pertaining to pest management activities are available as hard copy or electronic files for review on request.
The pest-sighting log has a designated location.
The pest-sighting log includes: Date, Time, Type of pests observed, Actions taken, and Names of reporting personnel
Pest management personnel review the log each quarter to identify trends in pest activity. A report of findings is submitted to designated facility personnel.
Corrective Actions are documented for identified issues.

Wildlife Control In addition to rodents, insects, and birds, other animals can become pests if left unmanaged.

Wildlife establishing habitat on the facility grounds or in the facility are removed in accordance with regulations and local ordinances. Wildlife can include dogs, cats, or other domestic animals.
Wildlife control measures are considered, where appropriate. Optional devices include: Wire, Netting, Distracting devices, Repellents, and Materials that prevent entry.

Pest Habitat Attractive habitat in or around a facility increases the chances of pest problems.

The facility addresses and eliminates any rodent burrows, rodent runs, and conditions that provide harborage or may attract rodents or other pests to the facility or outside grounds.
Implementation of an effective pest management program is demonstrated through the lack of identified pest activity. Specifically, pest activity whose identification and control is managed as part of the IPM Program.
(AU) Is there evidence of any one of the following within the facilities storage areas: houseflies or fruit fly infestation? Any cockroach activity? Visual presence of live rodents? Evidence of rodent excreta or gnaw marks on finished products? Any decomposed rodent? Birds residing in processing areas or warehouses? Bird excreta present within the facility? Pesticides used inconsistently with label directions?

Bird Control Bird control is addressed as part of the IPM Program to prevent contamination of food products.

Birds are controlled by exclusion with: Nets, Traps, Appropriate structural modifications, and/or Other approved legal methods
Avicides are only used if legal. Avicides are used according to label directions and local regulations.

Credentials and Competencies The facility protects its food products by verifying that IPM service providers, whether in-house or contractors, are qualifi ed.

The facility keeps a copy of the certification or registration document for each person who performs pest management services in the facility, as required by regulation.
Applicators provide verification of GMP training.
IPM service providers are supervised by a licensed applicator, if required or allowed by regulation.
The facility maintains a current copy of the certificate of insurance that specifies the liability coverage, where available.
IPM service providers maintain evidence of competency by exam from a recognized organization.
The facility maintains a current copy of the pest management company license issued by the appropriate government body, if required.

5. 5. Adequacy of Prerequisite and Food Safety Programs

Are the Adequacy of Prerequisite and Food Safety Programs within the scope of this inspection?
The Adequacy of Prerequisite and Food Safety Programs was not included in the scope of this inspection.

Written Policy The facility emphasizes its commitment to safe and legal food products through clearly defined and documented statements (Food Safety Policy).

There is a written Policy Statement that outlines the facility’s commitment to produce safe, legal products for consumers.
Senior management signs the Policy Statement. The Policy Statement is regularly communicated throughout the facility. Senior management regularly reviews the Policy Statement. Supervisory staff and key personnel are trained to understand and implement the Policy Statement.

Accountability Management authorizes and supports a qualified, supervisory-level person to ensure facility compliance to Programs, law, and regulation.

Supervisory personnel monitor the effectiveness of the implementation of the Prerequisite and Food Safety Programs.
The facility has a current and accurate organizational chart that shows who is responsible for ensuring compliance to regulatory laws and guidelines.
The facility has a documented procedure to keep the Prerequisite and Food Safety Programs current and accurate. Important new information could include: Legislation, Food safety issues, Scientific and technical developments, and Industry codes of practice.
Facilities define written procedures to meet legislative requirements as defined by country or export requirements (e.g., allergen labeling and control, Reportable Food Registry, Food Safety Modernization Act, etc.). The facility is aware of the program and its role in implementing the requirements.

Support Management supplies human and financial resources to support the Prerequisite and Food Safety Programs.

All departments directly involved in implementing Prerequisite and Food Safety Programs have budget and labor support to maintain the proper and timely acquisition of appropriate tools, materials, equipment, monitoring devices, chemicals, or other support.

Written Procedures All Prerequisites in the facility have written Programs that include procedures. Procedures are critical to food safety because they specify owners, actions, and timelines.

Procedures define: Job Descriptions that identify responsibilities related to Prerequisite and Food Safety Programs, and Alternates/Deputies that are designated to cover for the absence of key personnel. The written procedures are readily available to facility personnel.

Training and Education Regularly scheduled and tracked training and education ensure that the facility appropriately implements Prerequisite and Food Safety Programs. Training and education is for all personnel, from entry level workers to management.

There are written procedures for developing and delivering Prerequisite and Food Safety training and education to all personnel.
There are written procedures for developing and delivering Prerequisite and Food Safety training and education to all personnel.
The training includes established means for verification of competency of the information presented (e.g., testing, supervisor verification, verbal responses, etc.).
Prior to beginning work, new employees, temporary personnel, and contractors are trained and educated on Prerequisite and Food Safety Programs. These personnel are then supervised for compliance.
Refresher training and education are done at a minimum of annually or more often as needed.

Self-Inspections Responsible personnel regularly assess how well the facility implements and monitors Prerequisite and Food Safety Programs.

The facility has a formal Food Safety Committee. The Food Safety Committee has members from multiple functions of the facility.
The Food Safety Committee schedules and conducts self-inspections of the entire facility and outside grounds at least monthly.
The Food Safety Committee documents the results of the self-inspection. The documentation includes: Identified observations, Corrective Actions, Specific assignments, Actual accomplishments
Results of the self-inspection are brought to the attention of the personnel responsible for the activity inspected.
The Food Safety Committee and the responsible key personnel set deadlines for Corrective Action implementation.
The results of Corrective Actions are verified to ensure satisfactory completion. Follow-up inspections ensure that observations are corrected.

Written Procedure Audits Once procedures are written and personnel are trained, the facility regularly audits the written procedures to ensure they are still valid.

The scope and frequency of the audit is based on risk assessment or importance of activity. Audits are conducted at least annually and assess execution of the program.
The audits are carried out by competent auditors that are independent of the area of operation being evaluated.
The auditor documents the results of the audit. The documentation includes: Identified observations, Corrective Actions, Specific assignments, and Actual accomplishments.
Results of the audit are brought to the attention of the personnel responsible for the activity being audited.
Responsible key personnel set deadlines for Corrective Action implementation.
The results of Corrective Actions are verified to ensure satisfactory completion.

Customer Complaint Program A written Program for evaluating customer complaints allows the facility to respond to customer concerns. Complaints involving food safety issues, such as adulteration, require an immediate response.

The facility has a written Chemical Control Program that addresses all chemicals used in the facility (e.g., chemicals for Integrated Pest Management, Maintenance, Sanitation, Hygiene, and Laboratories).
Procedures address, as applicable: Chemical approval, Purchase authority, Controlled and segregated storage, Handling, Labels/Labeling, Identification of where and how the chemicals are to be used, Concentration verification, Training and education, Actual usage, Inventory control, Chemical disposal, Container disposal, Spill containment and control, Chemical Safety Data Sheet archiving, and Contractor chemicals.

Allergen Control Program The Allergen Control Program controls known allergens throughout the production process from receiving to distribution

The facility has a written Allergen Control Program that addresses allergens specific to country regulations.
Procedures address: Identification and segregation of allergens during storage and handling based on risk assessment conducted by the facility, Prevention of cross contact or contamination during processing by using measures such as: ◊ Control of rework and ◊ Equipment and utensils management; Personnel awareness training and education, Defined cleaning procedures to remove any spills to prevent allergen contamination or cross contact as defined by the risk assessment and written Allergen Control Program.
The Program is updated when there are changes in Food Products.

Glass, Brittle Plastics, and Ceramics Program A Program supports proactive steps to prevent contamination from glass, brittle plastics, and ceramics.

The facility has a written Glass, Brittle Plastics, and Ceramics Program.
The written Glass, Brittle Plastics, and Ceramics Program includes the following policy statements: All light bulbs, fixtures, windows, mirrors, skylights, and other glass over exposed product zones are protected against glass breakage (e.g., rework, repackaging, etc.). All other glass that is not of the safety type or otherwise protected is managed as part of the Glass, Brittle Plastics, and Ceramics Program; Glass in personal belongings is restricted to break areas or other designated controlled areas.
Procedures address: Handling breakage (including stored glass, brittle plastics, or ceramics), A register/list of essential glass, brittle plastics, and ceramics, Scheduled inspections of essential glass, brittle plastics, and ceramics to check for accidental breakage or damage.

Cleaning Program A Cleaning Program with schedules and procedures for accomplishing tasks is critical for maintaining a wholesome and safe food-processing environment.

The facility has a written Cleaning Program.
The written Cleaning Program includes the following schedules: A Master Cleaning Schedule (MCS) for periodic cleaning assignments and A Housekeeping Schedule for daily cleaning assignments. The cleaning tasks are divided into three general areas and are included on the appropriate schedule: Daily (Housekeeping Schedule), Periodic (Master Cleaning Schedule), and Maintenance (Master Cleaning Schedule).
The Master Cleaning Schedule addresses all equipment, structures, and grounds that impact food products. The MCS is current and accurate, and includes the following: Frequency of activities, Personnel responsible, Post-cleaning evaluation techniques, which could include visual inspections, Documented Corrective Actions
The facility has written cleaning procedures for all equipment, structures, and grounds that impact the storage food products. Cleaning procedures address (when necessary): Chemicals, Chemical concentrations, Tools, and Disassembly instructions.

Preventive Maintenance Program The Preventive Maintenance Program addresses building, utensil, and equipment maintenance to ensure a safe food production environment.

The facility has a written Preventive Maintenance Program and work order system that prioritizes structural, equipment, or utensil maintenance problems that could cause risk to food / food contamination. Records indicating compliance are maintained.

Receiving Program The Receiving Program ensures that raw materials are reviewed and received to prevent product contamination.

The facility has a written Receiving Program.
Trained personnel, using appropriate equipment, inspect all incoming ingredients, packaging, and vehicles. The facility has written procedures for inspecting incoming materials. Procedures for deliveries receipt include steps for evaluation of: presence of pest evidence, presence of other objectionable materials, and trailer or rail car condition. Incoming vehicle procedures include handling Less Than Load (LTL) vehicles.
The results of inspections are documented. Documented results of inspections include: Date of receipt, Carrier, Lot number, Temperatures (if required), Amount, Intact and verified seal numbers (if used), Product condition, trailer/railcar condition.

Food Defense Program The Food Defense Program identifies and reduces the risk of intentional harm to the facility, its personnel, and food products.

The facility maintains evidence of FDA registration under the Bioterrorism Act and re-registers at the frequency defined by the FDA. This requirement applies only if the facility manufactures, processes, packs, holds and distributes, or exports food for human or animal consumption in the USA.
The facility conducts a Vulnerability Assessment, and documents the results. Acceptable Vulnerability Assessments may include: Operational Risk Management (ORM), Threat Evaluation Assessment and Management (TEAM), CARVER + Shock, Internal assessment form, or C-TPAT.
The written Food Defense Program considers the Vulnerability Assessment results and includes information related to: A trained Coordinator, Food Defense Team, members and contact information, Key regulatory agency representatives and contact information, First responders and contact information, Annual documented Food Defense training and education, and Annual Food Defense Program review.

Traceability Program The Traceability Program enables the facility to quickly locate suspect raw materials, food contact packaging materials, rework, and related finished product.

The facility has a written Traceability Program that is regularly reviewed.
The facility identifies and documents lot numbers for: Repackaging, Finished product, and Distribution to the customer, where appropriate.
All finished products are coded and recorded.

Recall/Withdrawal Program Once a suspect product is located, the Recall or Withdrawal Program outlines the procedures for the quick and controlled removal of the product from the market.

The facility has a written Recall/Withdrawal Program that is regularly reviewed. The facility maintains distribution records of the initial point of distribution for all food products by specific lot.
The facility identifies and documents lot numbers for: Repackaging, Finished product, and Distribution to the customer, where appropriate.
The written Recall/Withdrawal Program includes information related to: Recall/Crisis Management team contact information: corporate, emergency, and after hours; roles and responsibilities for team members, Location of the Traceability Program, Key regulatory agency representative emergency contact information, Supplier (including food contact packaging) and customer emergency contact information, and Sample recall/withdrawal notification letters.

Nonconforming Product Program The Nonconforming Product Program provides guidelines for isolation, investigation, and disposition of returned goods, and finished products that do not meet food safety requirements.

The facility has a written Nonconforming Product Program.
Procedures address: Investigation of the cause of nonconformity, and whether there is a food safety risk, Time-sensitive Corrective Actions based on the seriousness of the risk identified, Documentation of actions taken, Handling and disposal according to the nature of the problem and/or the specific requirements of the customer
The written Recall/Withdrawal Program includes information related to: Recall/Crisis Management team contact information: corporate, emergency, and after hours; roles and responsibilities for team members, Location of the Traceability Program, Key regulatory agency representative emergency contact information, Supplier (including food contact packaging) and customer emergency contact information, and Sample recall/withdrawal notification letters.
Disposition of nonconforming material is traceable for recall or withdrawal.
Disposition can include: Rejection, Acceptance with restrictions, Regrading. The facility documents damaged or destroyed materials, and adjusts inventories as necessary.

Release Procedures Release procedures ensure that materials are checked for defined food safety hazards before being released into the facility or shipped to a customer requirements.

The facility follows release procedures. Products are not released unless all release procedures have been followed. Finished product are only released by authorized personnel.

Customer Complaint Program A written Program for evaluating customer complaints allows the facility to respond to customer concerns. Complaints involving food safety issues, such as adulteration, require an immediate response.

The facility has a written Customer Complaint Program. The Customer Complaint Program includes a procedure for quick distribution of complaint information to all departments responsible for implementing Prerequisite and Food Safety Programs. Actions appropriate to the seriousness and frequency of the complaint are carried out promptly and effectively. Complaint information is used to implement ongoing improvements to avoid issue recurrence, and to ensure product safety.

Inspection Summary of Results

Name and signature of the facility representative
Name and signature of the person performing the inspection.

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Rejection of Shipments/Receipt of Dry Goods A facility can safeguard its food products by identifying and barring entry or shipment of potentially contaminated raw materials or finished products.

Storage Practices Finished products are stored in a way to meet Program requirements for safe storage of materials.

Finished Product Inventory Finished product inventories are maintained at reasonable volumes to avoid excessive age and insect infestation.

Pallets Clean and well-maintained pallets minimize opportunities for contamination.

Designated Rework Areas Rework or salvage, if not segregated and managed properly, can cause contamination of packaging or finished product.

Cross Contamination Prevention Incompatible or hazardous materials require separate handling to prevent contamination.

Finished Product Transportation Finished product is coded for traceability, and shipping requirements are in place to prevent product contamination.

Hand Washing Facilities Personnel are provided the equipment to effectively remove contamination from their hands.

Washrooms, Showers, and Locker Rooms Cleanliness diminishes chances of contamination being spread from personnel areas.

Personal Hygiene Personnel conform to hygiene practices to avoid becoming a source of contamination.

Personal Items and Jewelry Control Personal items and jewelry present product contamination risks if not controlled.

Health Conditions Facility policies are in place and enforced to prevent disease, illness, or infection from contaminating product.

Non-Facility Personnel Visitors and contractors are required to comply with facility policies to protect product from contamination.

Waste Material Disposal Waste materials and their removal are managed to avoid contamination.

Facility Location Selection and management of the facility location will allow personnel to identify and control potentially negative impacts of surrounding operations.

Outside Grounds and Roof The facility grounds are maintained in a way that prevents food adulteration.

Layout Spacious layout and placement of equipment, materials, and structures facilitates inspection, cleaning, and maintenance activities.

Floors The floors of the facility are designed and maintained to provide structural integrity, facilitate cleaning, prevent contamination, and eliminate pest harborage or entry.

Drains The drains in the facility are designed and maintained to provide structural integrity, facilitate cleaning, prevent contamination, and eliminate pest harborage or entry.

Walls The walls of the facility are designed and maintained to provide structural integrity, facilitate cleaning, prevent contamination, and eliminate pest harborage or entry.

Ceilings and Overhead Structures Structural elements such as ceilings, beams, supports, fixtures, ducts, pipes, or equipment do not threaten food product with leaking, loose, chipping, flaking, or peeling material.

Air Makeup Units Air used in the facility is filtered or screened, and filters and screens are maintained to prevent product contamination.

Pest Prevention The materials, structure, and maintenance of the building and equipment support the Integrated Pest Management Program.

Cross Contamination Prevention Different steps in the production of food products can negatively impact processing in other areas. Segregation of operations minimizes opportunities for food hazards to arise.

Equipment and Utensil Construction Equipment and utensils designed for easy maintenance ensure compliance with Prerequisite and Food Safety Programs. Surfaces that deteriorate, or cannot be cleaned or maintained, may present product contamination hazards.

Temporary Repair Materials Temporary repairs are sometimes needed or unavoidable. Procedures to ensure that they do not become a contamination hazard are defined.

Hand Washing Facilities Design Personnel are provided the equipment to effectively remove contaminants from their hands.

Facility Location Selection and management of the facility location will allow personnel to identify and control potentially negative impacts of surrounding operations.

Cleaning Cleaning is more than making the facility look good. Cleaning methods and scheduling take food safety into account.

Support Area Cleaning Cleaning support areas eliminates product residues that may allow insect development, mold, or other contaminants that could affect the product or impact production.

Equipment and Tools Cleaning equipment and tools may have a negative impact on food safety if not managed properly.

Integrated Pest Management (IPM) Program A written IPM Program ensures the facility has effective controls and processes in place to minimize pest activity.

Facility Assessment An annual assessment of the facility provides an evaluation of the IPM Program to ensure that it is effective.

Other Guidelines Facilities that use alternative guidelines (such as organic, green, or sustainable) are also held accountable for having IPM Programs.

Signed Contracts A signed contract between the facility and external IPM providers holds both the provider and the facility accountable for effective pest management activities.

Pesticide Documentation The facility maintains current pesticide label and Chemical Safety Data Sheet information to ensure proper usage of pesticide chemicals.

Pesticide Application Documentation The facility maintains records to identify, verify, and document compliance to regulatory and IPM requirements.

Pesticide Application Documentation The facility maintains records to identify, verify, and document compliance to regulatory and IPM requirements.

Pesticide Control Pesticides are managed as part of the Chemical Control Program.

Monitoring Device Documentation Monitoring device documentation is maintained to ensure that devices are properly placed and inspected, and to allow trend analysis of activity.

Exterior Rodent Monitoring Devices Management of exterior rodent monitoring devices deters rodents from entering the facility.

Interior Rodent Monitoring Devices Interior rodent monitoring devices identify and capture rodents that gain access to the facility.

Insect Light Traps When used, insect light traps assist in the identification and monitoring of flying insects.

Trend Analysis Documentation of pest sightings and activity are reviewed and used to identify and eliminate areas where pest activity is observed, and to document Corrective Actions taken.

Wildlife Control In addition to rodents, insects, and birds, other animals can become pests if left unmanaged.

Pest Habitat Attractive habitat in or around a facility increases the chances of pest problems.

Bird Control Bird control is addressed as part of the IPM Program to prevent contamination of food products.

Credentials and Competencies The facility protects its food products by verifying that IPM service providers, whether in-house or contractors, are qualifi ed.

Written Policy The facility emphasizes its commitment to safe and legal food products through clearly defined and documented statements (Food Safety Policy).

Accountability Management authorizes and supports a qualified, supervisory-level person to ensure facility compliance to Programs, law, and regulation.

Support Management supplies human and financial resources to support the Prerequisite and Food Safety Programs.

Written Procedures All Prerequisites in the facility have written Programs that include procedures. Procedures are critical to food safety because they specify owners, actions, and timelines.

Training and Education Regularly scheduled and tracked training and education ensure that the facility appropriately implements Prerequisite and Food Safety Programs. Training and education is for all personnel, from entry level workers to management.

Self-Inspections Responsible personnel regularly assess how well the facility implements and monitors Prerequisite and Food Safety Programs.

Written Procedure Audits Once procedures are written and personnel are trained, the facility regularly audits the written procedures to ensure they are still valid.

Customer Complaint Program A written Program for evaluating customer complaints allows the facility to respond to customer concerns. Complaints involving food safety issues, such as adulteration, require an immediate response.

Allergen Control Program The Allergen Control Program controls known allergens throughout the production process from receiving to distribution

Glass, Brittle Plastics, and Ceramics Program A Program supports proactive steps to prevent contamination from glass, brittle plastics, and ceramics.

Cleaning Program A Cleaning Program with schedules and procedures for accomplishing tasks is critical for maintaining a wholesome and safe food-processing environment.

Preventive Maintenance Program The Preventive Maintenance Program addresses building, utensil, and equipment maintenance to ensure a safe food production environment.

Receiving Program The Receiving Program ensures that raw materials are reviewed and received to prevent product contamination.

Food Defense Program The Food Defense Program identifies and reduces the risk of intentional harm to the facility, its personnel, and food products.

Traceability Program The Traceability Program enables the facility to quickly locate suspect raw materials, food contact packaging materials, rework, and related finished product.

Recall/Withdrawal Program Once a suspect product is located, the Recall or Withdrawal Program outlines the procedures for the quick and controlled removal of the product from the market.

Nonconforming Product Program The Nonconforming Product Program provides guidelines for isolation, investigation, and disposition of returned goods, and finished products that do not meet food safety requirements.

Release Procedures Release procedures ensure that materials are checked for defined food safety hazards before being released into the facility or shipped to a customer requirements.

Customer Complaint Program A written Program for evaluating customer complaints allows the facility to respond to customer concerns. Complaints involving food safety issues, such as adulteration, require an immediate response.

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