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• Conducted on Date
• Prepared by

5.3 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.

Critical Requirements

• 5.3.1.1 There are written procedures for developing and delivering Prerequisite Food Safety (HACCP) and Food Defense training and education to all personnel. Procedures include training as required by regulations.

1.22 Controlled Temperature for Food Safety

• Temperature controls prevent the growth of pathogens in susceptible materials.

Critical Requirements

• 1.22.1.1 Raw materials, work-in-process, and finished product capable of supporting the rapid growth of pathogenic microorganisms are properly stored.

Minor Requirements

• 1.22.2.1 Continuous recording thermometers are placed in all rooms or areas where perishable foods are stored and handled.

5.1 Accountability

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

Critical Requirements

• 5.1.1.1 Supervisory personnel monitor the effectiveness of the implementation of the Prerequisite and Food Safety Programs.

5.2 Support

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

Critical Requirements

• 5.2.1.1 Adequate resources are provided to support effective implementation of the Prerequisite and Food Safety Program.

5.4 Self-Inspections

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

Critical Requirements

• 5.4.1.1 The facility has a formal Food Safety Committee.

Minor Requirements

• 5.4.1.6 The results of Corrective and Preventive Actions are verified to ensure satisfactory completion.

5.5 Written Procedure Audits

• Once procedures are written and personnel are trained, the facility regularly audits the written procedures to ensure that are still valid and effective.

Critical Requirements

• 5.5.1.1 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.

5.6 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.

Critical Requirements

• 5.6.1.1 The facility has a written Customer Complaint Program.

5.8 Microbial Control Program

• Pathogens and spoilage organisms can contaminate foods if not managed for raw materials, packaging materials, work-in-process, finished product, or micro-sensitive processes.

Critical Requirements

• 5.8.1.1 The facility has completed a risk assessment and has a written Microbial Control Program that addresses microbiological analysis for raw materials, finished product, production, and packaging as dictated by the assessment.

5.9 Allergen Control Program

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

Critical Controls

• 5.9.1.1 An Allergen Control Program is in place that addresses allergens as handled in the facility and as required by regulations in the country of manufacture and county of export.

5.10 Glass, Brittle Plastics, and Ceramics Program

• A program supports proactive steps to prevent contamination from glass, brittle plastics, and ceramics.

Critical Requirements

• 5.10.1.1 The facility has a written Glass, Brittle Plastics (acrylic), and Ceramics Program.

5.14 Regulatory Affairs and Inspections Program

• The Regulatory Affairs and Inspections Program prepares the facility to handle regulatory, third-party, and customer inspections.

Critical Requirements

• 5.14.1.1 The facility has a written Regulatory Affairs and Inspections Program that includes:
  -A list of personnel delegated to accompany all Inspectors
  -A policy regarding recording devices and cameras
  -A policy regarding record and sample taking

5.15 Food Defense Program

• The Food Defense plan identifies and reduces the risk of intentional harm to food products.

Critical Requirements

• 5.15.1.1 The facility has a written Vulnerability Assessment, which is performed by person(s) trained in Food Defense. Vulnerability assessment is reviewed on a frequency based on regulation or at least annually.

5.16 Traceability Program

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

Critical Requirements

• 5.16.1.1 The facility has a written Traceability Program that is regularly reviewed.

Minor Requirements

• 5.16.2.1 The facility maintains country of origin information for materials as required by regulations.

5.17 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.

Critical Requirements

• 5.17.1.1 The facility has a written Recall/Withdrawal Program that is regularly reviewed.

5.18 Non-Conforming Product Program

• The Non-Conforming Product Program provides guidelines for isolation, investigation, and disposition of raw materials, packaging materials, work-in-process, returned goods, and finished products that do not meet food safety requirements.

Critical Requirements

• 5.18.1.1 The facility has a written Non-Conforming Product Program.

Minor Requirements

• 5.18.2.1 Disposition can include:
  -Rejection
  -Acceptance with restrictions
  -Regrading

5.23 Food Safety Plan

• The Food Safety Plan evaluates hazards associated with the raw materials and process steps related to a product or product category. It includes a Hazard Analysis which typically assesses risk by determining the severity of a hazard and its likelihood of occurrences. The goal of a food safety plan is to prevent, eliminate, or reduce hazards to an acceptable level.

Critical Requirements

• 5.23.1.1 The facility has identified all applicable regulatory requirements for food safety plans.

5.25 Release Procedures

• The facility defines and follows release procedures for materials on positive hold. Examples could include, but are not limited to, pending receipt of food safety testing results, document review, or other protocols.

Critical Requirements

• 5.25.1.1 The facility defines and follows release procedures.

5.27 Water Quality

• Water, water sources, and water management strategies provide clean water is safe for food contact activities.

Critical Requirements

• 5.27.1.1 The facility's water supply complies with regulatory requirements.

2.15 Temporary Repair Materials

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

Critical Requirements

• 2.15.1.1 Tape, wire, string, cardboard, plastic, and other temporary materials are not used for permanent repairs. If used for emergency repairs, they are dated, controlled, and replaced with a permanent repair as soon as possible.

Minor Requirements

• 2.15.2.1 Temporary repair issues are resolved as soon as possible and practical.

5.12 Preventative Maintenance Progam

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

Critical Requirements

• 5.12.1.3 Records indicating compliance are maintained.

1.1 Rejection of Shipments/Receipt of Dry Goods

• A facility can safeguard its food products by identifying and barring entry or shipment of potentially contaminated materials. Materials may include but are not limited to raw materials, ingredients, processing aids, finished products, returned goods, as well as equipment and/or returned containers, trays, dollies, and carts.

Critical Requirements

• 1.1.1.1 Damaged, infested, or dirty transports/containers or materials are rejected.

1.25 Finished Product Transportation

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

Critical Requirements

• 1.25.1.1 Legible code marks that are easily seen by consumers are placed on all finished products.

Minor Requirements

• 1.25.2.2 Interior light bulbs in finished product transports are shielded or coated to prevent breakage.

5.13 Receiving Program

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

Critical Requirements

• 5.13.1.1 The facility has a written Receiving Program.

Cleaning Practices/Cleaning Program

3 Cleaning Practices

• The cleaning and sanitizing of equipment, utensils, and buildings to provide a wholesome and safe processing environment.

3.2 Cleaning Compounds and Sanitizers

• Cleaning compounds and sanitizers are considered chemicals under the Chemical Control Program.

Critical Requirements

• 3.2.1.1 All cleaning compounds and sanitizers used to clean food contact surfaces have food contact surface approval documentation.

3.5 Daily (Housekeeping) Cleaning

• Daily cleaning focuses on keeping the facility consistently neat and clean.

Critical Requirements

• 3.5.1.1 Daily cleaning tasks are completed in a way that prevents contamination.

3.7 Periodic Cleaning Tasks/Product Zone Cleaning

• Periodic cleaning tasks involve a less frequent deep cleaning that may only be conducted when the area is not in production. these tasks require personnel who have been trained, and they often demand the assistance of maintenance or production personnel to properly disassemble equipment and provide effective cleaning of the product zone to prevent product contamination.

Critical Requirements

• 3.7.1.1 Periodic cleaning tasks comply with applicable equipment cleaning procedures, which are being followed.

3.8 Maintenance Cleaning

• Debris created during maintenance work as well as small maintenance tools and parts may create contamination issues if effective cleaning does not take place after maintenance work is completed and before start-up of the line.

Critical Requirements

• 3.8.1.1 Maintenance cleaning tasks are completed in a way that does not compromise product safety. This includes, but is not limited to, removal of debris after maintenance tasks are complete (such as nuts, bolts, washers, wire pieces, tape, welding rods, and other small items) that could contaminate product, and accounting for these materials.

5.11 Cleaning Program

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

Critical Requirements

• 5.11.1.1 The facility has a written Cleaning Program.

Minor Requirements

• 5.11.2.1 The cleaning tasks are divided into three general areas and are included on the appropriate schedule:
  -Daily (Housekeeping Schedule)
  -Periodic (Master Cleaning Schedule)
  -Maintenance (Master Cleaning Schedule)

5.7 Chemical Control Program

• A written Program for managing all chemicals in the facility provides a centralized approach to identifying and controlling purchases and use of non-food chemicals.

Critical Requirements

• 5.7.1.1 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).

4. Integrated Pest Management

• The assessment, monitoring, and management of pest activity to identify, prevent, and eliminate conditions that could promote or sustain a pest population.

4.1 Integrated Pest Management (IPM) Program

• A written IPM Program ensures the facility has effective controls and processes in place to minimize pest activity.

Critical Requirements

• 4.1.1.1 The facility has a written Integrated Pest Management Program.

4.2 Facility Assessment

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

Critical Requirements

• 4.2.1.1 Internal or external trained IPM personnel conduct an assessment of the facility at least annually. Training includes at a minimum Pest Biology and applicable IPM regulations.

4.3 Scope of Service

• A clearly defined scope of service details all applicable pest management activities and responsibilities and serves as the foundation for an effective IPM program.

Critical Requirements

• 4.3.1.1 The defined scope of service includes:
  -Both the facility and the IPM company name
  -IPM contact person both for the facility and the contractor
  -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 ntoify facility of any changes in service or materials used

4.4 Credentials and Competencies

• The facility protects its food products by verifying that IPM service providers, whether-in house or contractors, are qualified.

Critical Requirements

• 4.4.1.1 The facility keeps a copt of the certification or registration document for each person who performs pest management services in the facility, as required by regulation.

Minor Requirements

• 4.4.2.1 IPM service providers maintain evidence of competency by exam from a recognized organization.

4.5 Pesticide Documentation

• The facility maintains current pesticide label and other technical information as applicable, to ensure proper usage of the pesticide chemicals and eliminate food safety issues.

Critical Requirements

• 4.5.1.1 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.

Minor Requirements

• 4.5.2.1 The language of the country is taken into consideration when providing Technical Safety Data Sheets and labels.

4.6 Pesticide Application Documentation

• The facility maintains records to identify, verify, and document compliance to regulatory and IPM requirements.

Critical Requirements

• 4.6.1.1 Documented pesticide application activities include:
  -Product named 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
  -Printed name and signature of applicator

Minor Requirements

• 4.6.2.1 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.

4.7 Pesticide Control

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

Critical Requirements

• 4.7.1.1 Pesticides are stored in a limited access, locked area. Storage areas are adequate in size and construction, and are properly ventilated.

4.8 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.

Critical Requirements

• 4.8.1.1 accurate and complete service records describe current levels of pest activity and recommendations for additional Corrective Actions.

4.9 Monitoring Device Documentation

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

Critical Requirements

• 4.9.1.1 A detailed survey of the entire facility is completed, and the results are documented and used to determine placement of monitoring devices.

4.10 Exterior Rodent Monitoring Devices

• Management of exterior rodent monitoring devices deters rodents from entering the facility.
• 4.10.1.1 The placement of exterior rodent monitoring devices is based on the detailed facility survey and activity history or as required by country or local regulatory requirements. In the absence of an assessment, devices are placed at intervals of 50-100 ft or 15-30 m.

Minor Requirements

• 4.10.2.1 Evidence of non-target wildlife feeding at the exterior monitoring locations, where rodenticides are used, is evaluated and addressed as required by regulations.

4.11 Interior Rodent Monitoring Devices

• Interior rodent monitoring devices identify and capture rodents that gain access to the facility.

Critical Requirements

• 4.11.1.1 Toxic bait is not used for interior monitoring.

4.12 Insect Light Traps

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

Critical Requirements

• 4.12.1.1 Insect light traps, when used, are installed farther than 10 ft or 3 m from food contact surfaced, exposed products, packaging, and raw materials in processing or storage areas.

Minor Requirements

• 4.12.2.1 Insect light trap tubes are changed at least annually at the beginning of the active season or based on the manufacturer's recommendations.

4.13 Pheromone Monitoring Devices

• Pheromone monitoring devices assist in the identification of stored product insect pests in areas prone to this type of infestation (e.g., grains, cereals, spices, or herbs).

Critical Requirements

• 4.13.1.1 When used, pheromone monitoring devices, appropriate to the pest species are installed, maintained and replaced according to label requirements and the annual IPM assessment.

4.14 Bird Control

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

Critical Requirements

• 4.14.1.1 Birds are controlled by exclusion with:
  -Nets
  -Traps
  -Appropriate structural modifications
  -Other approved legal methods

4.15 Wildlife Control

• In addition to rodents, insects, and birds, other animals can become pests if left un-managed.

Critical Requirements

• 4.15.1.1 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.

Minor Requirements

• 4.15.2.1 Wildlife control measures are considered, where appropriate. Optional devices include:
  -Wire
  -Netting
  -Distracting devices
  -Repellants
  -Materials that prevent entry

4.16 Identified Pest Activity

• Identified pest activity and attractive habitat in or around facility, if not addressed effectively, increase the chances of pest problems with severe impact on food safety.

Critical Requirements

• 4.16.1.1 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.

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