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.

  • 5.3.1.2 Training and education records for all personnel are maintained.

  • 5.3.1.3 The training includes established means for verification of competency of the information presented (e.g., testing, supervisor verification, verbal responses, etc.).

  • 5.3.1.4 Prior to beginning work, new employees, temporary personnel, and contractors are trained and educated on Prerequisite and Food Safety Programs, as related to their job function and level of responsibility. These personnel are then supervised for compliance.

  • 5.3.1.5 Refresher training and education are done at a minimum of annually or more often as needed.

Quality

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.

  • 1.22.1.2 Temperature limits for food safety, based on science and regulation as applicable, are defined and followed, including but not limited to storage, thawing, tempering, and holding of hot food.

  • The facility maintains a record of temperature monitoring activities.

  • 1.22.1.4 Corrective actions are defined and implemented for materials affected by controlled temperature storage failures that could affect food safety.

Minor Requirements

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

  • 1.22.2.2 Temperature monitoring probes are placed at the warmest parts of temperature-controlled storage facilities.

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.

  • 5.1.1.2 The facility has documented procedures to keep the Prerequisite and Food Safety Programs current and accurate, which include accountability and compliance to statutory and regulatory laws and guidelines pertaining to food safety and legality. Important new information could include:
    -Legislation
    -Food Safety Issues
    -Scientific and technical developments
    -Industry codes of practice

  • 5.1.1.3 Companies define written procedures to identify new food safety regulations. Facilities register with appropriate Government Agencies based on site locations and countries of export.

  • 5.1.1.4 Procedures define:
    -Job description that identify responsibilities related to Prerequisite and Food Safety Programs
    -Alternates/Deputies that are designated to cover for the absence of key personnel.

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.

  • 5.4.1.2 The Food Safety Committee schedules and conducts self-inspections of the entire facility and outside grounds at least monthly.

  • 5.4.1.3 The Food Safety Committee documents the results of the self-inspection. The documentation includes:
    -Identified observations
    -Corrective Actions
    -Root Cause Analysis and Preventive Actions for significant food safety risks
    -Specific assignments
    -Actual accomplishments.

  • 5.4.1.4 Results of the self-inspection are brought to the attention of the personnel responsible for the activity inspected.

  • 5.4.1.5 The Food Safety Committee and the responsible key personnel set deadlines for Corrective Action implementation and Preventive Action as applicable.

Minor Requirements

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

  • 5.4.2.1 The Food Safety Committee has members from multiple functions in the facility.

  • 5.4.2.2 Follow-up inspections ensure that findings are addressed.

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.

  • 5.6.1.2 Complaint information is used to implement ongoing improvements to avoid issue recurrence and to ensure product safety.

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.

  • 5.8.1.2 Based on Risk Assessment and/or regulatory requirements, the Microbial Control Program includes monitoring that may include, but is not limited to, procedures to address:
    -Sanitation/Hygiene practices
    -Harborage site detection
    -Corrective/Preventive Actions
    -Raw materials
    -Finished product.

  • 5.8.1.3 Records are maintained of laboratory analyses and/or environmental samples that document compliance with the Microbial Control Program.

  • 5.8.1.5 Contract labs maintain appropriate accreditation to carry out the analyses performed.

  • 5.8.1.6 All products being tested for pathogens are placed on hold and not released until results indicating the food safety of the product have been obtained.

  • 5.8.1.7 Products that test positive (or above set legal limits) for pathogens are appropriately reprocessed or destroyed. Documentation of the disposition of these materials is maintained.

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.

  • 5.9.1.2 Procedure addresses:
    -Identification and segregation of allergens during storage and handling
    -Prevention of cross contact or contamination during processing by using measures such as:
    -Production run scheduling
    -Control of rework
    -Dedicated production lines
    -Comprehensive changeover procedures
    -Equipment and utensils management
    -Product label reviews and control
    -Personnel awareness training and education
    -Verification of cleaning procedures for food contact equipment
    -Approved Supplier Program for ingredients and labels
    -Validation as applicable or available

  • 5.9.1.3 The Program is updated when there are changes in:
    -Ingredients
    -Processing aids
    -Ingredient suppliers
    -Products
    -Processess
    -Labeling
    -Applicable regulations

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.

  • 5.10.1.2 The program includes the following policy statements:
    -No glass, brittle plastics, or ceramics are to be used in areas where potential for contamination might exist, except where absolutely necessary or where removal is not immediately feasible.
    -No glass, brittle plastics, or ceramics will be brought in with personal belongings.

  • 5.10.1.3 Procedure addresses:
    -Handling breakage (including stored glass, brittle plastics, and ceramics)
    -A register/list of essential glass, brittle plastics, and ceramics where potential for contamination might exist
    -Scheduled inspections of essential glass, brittle plastics, and ceramics to check for accidental breakage or damage

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.

  • 5.15.1.2 The Food Defense Plan includes mitigation measures based on the Vulnerability Assessment.

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.

  • 5.16.1.2 The facility identifies and documents lot numbers and traceability information for:
    -Raw materials
    -Rework
    -Food contact packaging materials
    -Work-in process
    -Finished product
    -Distribution to the customer
    -Processing aids

  • 5.16.1.3 All finished products are coded and recorded.

  • 5.16.1.4 The facility tests the program twice annually and documents the results:
    -Actual test results ( including a test for ingredients or food contact packaging material)
    -Success rate
    -Test timings
    -Corrective actions and process improvements where gaps in the program have been identified

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.

  • 5.17.1.2 The facility maintains distribution records of the initial point of distribution for all food products by specific lot.

  • 5.17.1.3 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
    -Type of crisis: food safety/food defense
    -Key regulatory agency representative emergency contact information
    -Supplier (including food contact packaging) and customer emergency contact information
    -Sample recall/withdrawal notification letters

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.

  • 5.18.1.2 Procedures address:
    -Investigation of the cause of non-conformity 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
    -Personnel authorized to determine product disposition

Minor Requirements

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

  • 5.18.2.2 The facility documents damaged or destroyed materials, and adjusts inventories as necessary.

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.

  • 5.23.1.2 Written food safety plans are in place where required by regulation.

  • 5.23.1.4 Records demonstrate compliance with food safety plans.

  • 5.23.1.5 Only qualified personnel who have defined responsibility for program compliance authorize the following:
    -Amendments to records
    -Corrective Actions
    -Verification of Corrective Actions

  • 5.23.1.6 Food Safety plans and procedures are reviewed as required on a frequency as defined by regulation. In the absence of regulation, reviews are conducted when there are product or process changes and at least annually.

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.

  • 5.25.1.2 Products are not released unless all release procedures have been followed.

  • 5.25.1.3 Raw materials, work-in-process, and/or finished product are only released by authorized personnel.

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.

  • 5.27.1.2 The facility has a safe and/or potable water supply from an approved source.

  • 5.27.1.3 Documentation of the results of water testing is on file.

  • 5.27.1.4 Water, steam, and ice that contacts food and food contact surfaces are regularly monitored to ensure that is no risk to product safety.

  • 5.27.1.5 Routine checks verify that back siphonage and back flow prevention units are functioning properly. Results are documented.

  • 5.27.1.6 Water treatment chemicals used in steam or water that comes into direct or indirect contact with food are approved for food contact.

  • 5.27.1.7 Water treatment chemicals are used according to label directions. Results of concentration testing and verification procedures are documented.

  • 5.27.1.9 Regular water samples are taken from underground well water supplies and surface water sites according to local health department codes and government requirements.

Maintenance

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.

  • 2.15.1.2 Any temporary repairs on food contact surfaces are constructed of food-grade material.

  • 2.15.1.3 The facility maintains a record of work orders or repair requests, which include progress and status.

  • 2.15.1.4 The facility follows temporary repair procedures, which include a list of materials approved for use as temporary repairs.

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.

  • 5.12.1.1 The facility has a written Preventative Maintenance Program and work order system that prioritizes structural, equipment or utensil maintenance problems that could cause food contamination.

Warehouse

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.

  • 1.1.1.2 Materials shipped in damaged, infested, or dirty vehicles are rejected.

  • 1.1.1.3 The facility maintains documentation of rejected shipments that includes defect specifications and reasons for rejection.

  • 1.1.1.4 Shuttle vehicles are in good condition, clean, and free of holes and infestation.

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.

  • 1.25.1.2 Code marks satisfy regulatory packaging requirements and lot definitions, and are used in the Recall Program.

  • 1.25.1.3 Distribution records identify the initial point of distribution as per regulatory requirements.

  • 1.25.1.4 Finished products are handled and transported in a way that prevents actual or potential contamination.

  • 1.25.1.5 Finished products are loaded or transferred in covered bays or canopies to protect the products from weather damage.

  • 1.25.1.6 Staging and loading of perishable materials does not pose a food safety risk.

  • 1.25.1.7 Documentation validates that temperature-sensitive products are loaded into pre-cooled vehicles that are designed to sustain required temperatures during delivery.

  • 1.25.1.8 Temperatures of vehicles, for temperature-controlled transports, are checked and recorded before loading.

  • 1.25.1.10 Prior to loading, all shipping vehicles and products are inspected for cleanliness, damage, or defects that could jeopardize the product.

  • 1.25.1.11 Shipping vehicle inspections are documented.

  • 1.25.1.12 Local delivery trucks and route trucks are inspected and cleaned at least weekly, or as defined by a risk assessment, to identify potential sources of foreign material contamination.

  • 1.25.1.13 Transport refrigeration devices have recording devices. In the absence of recording devices, manual temperature checks are documented at appropriate frequencies to ensure maintenance of refrigeration temperatures.

  • 1.25.1.14 Security seals or padlocks are provided, and their use is documented as per facility or customer requirements.

  • 1.25.1.15 Transport vehicles have not hauled garbage/waste or non-food items that may cause product contamination. If non-food items, such as chemicals, are shipped, then adequate barriers to prevent contamination of food products must be used.

Minor Requirements

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

  • 1.25.2.2 Adequate free air circulation is provided all around the load during perishables transportation. Pallets with slip-sheets or other ways to allow adequate air circulation are in place unless the transport has a channeled floor to maintain air circulation.

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.

  • 5.13.1.2 Trained personnel, using appropriate equipment, inspect all incoming ingredients, packaging, and vehicles.

  • 5.13.1.3 The facility has written procedures for inspecting incoming raw materials (ingredients and packaging).

  • 5.13.1.4 Procedures for tractor trailer, lorry, or rail deliveries include steps for evaluation of:
    -Raw material condition
    -Presence of pest evidence
    -Presence of other objectionable materials
    -Trailer or rail car condition

  • 5.13.1.6 Incoming vehicle procedures including handling Less Than Load (LTL) vehicles.

  • 5.13.1.7 The results of inspections are documented.

  • 5.13.1.8 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, lorry, or transport condition

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.

  • 3.2.1.2 Sanitizer concentrations are tested to make sure they are consistent with the product label.

  • 3.2.1.3 All cleaning chemicals are properly labeled.

  • 3.2.1.4 All cleaning chemicals are stored in a secure compartment away from production and food storage areas when chemicals are not in use.

  • 3.2.1.5 The facility follows verification procedures and maintains records of chemical concentration testing, retesting, and Corrective Actions.

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.

  • 3.5.1.2 Daily cleaning tasks are clearly assigned and completed.

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.

  • 3.7.1.2 Periodic cleaning tasks are scheduled on a Master Cleaning Schedule, or equivalent.

  • 3.7.1.3 Periodic cleaning tasks are assigned and completed.

  • 3.7.1.4 Equipment guards, trims, and panels are removed and replaced to inspect and clean the interior of all equipment, as applicable.

  • 3.7.1.5 Equipment and structural overheads (including lights, pipes, and beams) are scheduled for periodic cleaning on the Master Cleaning schedule to prevent mold, insect development, or other product contamination issues.

  • 3.7.1.6 Ventilation, air extracting ducts and bent grids are dismantled and cleaned on a defined frequency to prevent contamination issues.

  • 3.7.1.7 Food contact surfaces, product zones, and equipment that require sanitizing are cleaned and sanitized.

  • 3.7.1.8 Equipment and utensils that do not require sanitizing are cleaned on a predetermined schedule.

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.

  • 5.11.1.2 The written Cleaning Program includes the following schedules:
    -A Master Cleaning Schedule (MCS) for periodic cleaning assignments
    -A Housekeeping Schedule for daily cleaning assignments

  • 5.11.1.3 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
    -Allergen testing
    -Preoperative inspections
    -Adenosine triphosphate (ATP) testing
    -Equipment swabs
    -Documented Corrective Actions

  • 5.11.1.4 The facility has written cleaning procedures for all eqiupment, structures, and grounds that impact the storage, processing, and packaging of food products.

  • 5.11.1.5 Equipment cleaning procedures address:
    -Chemicals
    -Chemical concentrations
    -Tools
    -Disassembly instructions

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).

  • 5.7.1.2 Procedures address, as applicable:
    -Chemical approval
    -Purchase authority
    -Controlled and segregated storage
    -Handling
    -Labels/Labeling and/or Technical Data Sheets
    -Identification of where and how the chemicals are to be used
    -Concentration verification
    -Prevention of cross-contamination
    -Training and education
    -Actual usage
    -Inventory control
    -Chemical disposal
    -Container disposal
    -Contractor chemicals
    -Allergen declarations

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.

  • 4.1.1.2 The IPM Program incorporates the requirements of the facility's other written Prerequisite and Food Safety Programs.

  • 4.1.1.3 The IPM Program is written and implemented by trained in-house personnel or by registered, trained, or licensed contractors.

  • 4.1.1.4 If the IPM Program development and implementation is outsourced to contractors, the program includes responsibilities for both in-house personnel and contractors. An in-house, technically responsible person is appointed to monitor the execution of the 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.

  • 4.2.1.2 The assessment evaluates all areas inside and outside the facility, and includes:
    -Historical data from prior 12 months at a minimum
    -Identification of pest species present, including extent and distribution of presence
    -Assessment of the environment that could provide opportunity for pest harborage and proliferation
    -Previously applied corrective actions and their effectiveness

  • 4.2.1.3 Assessment results and Corrective Actions are documented and used to develop and update the IPM Program.

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.

  • 4.1.12 If regulation does not require certification or registration, IPM service providers are trained in the proper and safe use of pest management materials by attending a recognized seminar or some other documented training. Evidence of training is on file or available electronically.

  • 4.4.1.3 Persons conducting IPM services have documented GMP Training.

  • 4.4.1.4 IPM service providers are supervised by a licensed applicator, if required or allowed by regulation.

  • 4.4.1.5 The facility maintains a current copy of the pest management company license issued by the appropriate government body, if required.

  • 4.4.1.6 The facility maintains a current copy of the certificate of insurance that specifies the liability coverage, where available.

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.

  • 4.7.1.2 Pesticides are stored according to label directions.

  • 4.7.1.3 Pesticide containers and application equipment are labeled to identify contents. Application equipment is not used across multiple pesticides.

  • 4.7.1.4 Pesticide containers are disposed of according to label directions and regulatory requirements.

  • 4.7.1.5 Warning signs are posted at the entrance of each pesticide storage area.

  • 4.7.1.6 The facility maintains a complete inventory of all stored pesticides.

  • 4.7.17 Spill control materials and procedures are available.

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.

  • 4.8.1.2 The pest-sighting log or reporting system provides information about the response taken by pest management personnel.

  • 4.8.1.3 All records pertaining to pest management activities are available as hard copy or electronic files for review on request.

  • 4.8.1.4 The pest-sighting log or reporting system is available to facility personnel.

  • 4.8.1.5 Information gathered through the pest-sighting log or reporting system includes:
    -Date
    -Time
    -Type of pests observed
    -Location
    -Actions taken
    -Names of reporting personnel

  • 4.8.1.6 Pest sightings and activity evidence are reviewed by pest management personnel at least quarterly or more frequently to identify trends. A report of findings is submitted to designated facility personnel.

  • 4.8.1.7 Corrective Actions for identified issues are applied and documented as complete.

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.

  • 4.9.1.2 A current and accurate site map that lists the locations of all monitoring devices used for target pests on file.

  • 4.9.1.3 Temporary placement of any pest monitoring devices for short-term monitoring is also mapped. Device checks are documented according to the frequency defined by the IPM Program. Devices that are no longer needed are accounted for and removed.

  • 4.9.1.4 Records of all services performed on all pest-monitoring devices are available.

  • 4.9.1.5 service records for monitoring devices match IPM Program requirement.

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.

  • 4.10.1.2 All exterior monitoring devices are inspected at least monthly or more often if activity levels dictate.

  • 4.10.1.3 Exterior monitoring devices containing rodenticides are locked with single-use plastic ties, padlocks, or devices provided by the manufacturer, such as key systems.

  • 4.10.1.4 Exterior rodent monitoring devices are tamper resistant and are positioned, anchored in placed, locked, and labeled.

  • 4.10.1.5 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.

  • 4.10.1.6 Baits are secured inside bait stations, in good condition, and replaced as needed based on the label directions or manufacturer recommendation to avoid deterioration.

  • 4.10.1.7 When mechanical traps or non-toxic bait are used for exterior monitoring, that are checked frequently enough to identify rodent pressure outside the plant and provisions are in place for the detection of rodent activity, effectiveness, cleanliness and placement of the devices.

  • 4.10.1.8 Where prohibited by regulations, rodenticides are not used for regular monitoring.

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.

  • 4.11.1.2 Based on the detailed facility survey, interior monitoring devices are placed in sensitive areas specific to the rodent species, and other areas of rodent activity, which may include:
    -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 where roof rat activity is evident or likely
    -High traffic areas
    -Both sides of doors that open to the exterior of the facility. In the absence of an assessment, 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.

  • 4.11.1.3 Interior monitoring devices are placed along perimeter walls. The spacing and number of traps are based on activity levels.

  • 4.11.1.4 Interior monitoring devices are appropriately positioned, cleaned, and inspected at least weekly, or as otherwise defined in the IPM program based on the detailed facility assessment, if the facility can demonstrate the consistent performance of the equipment and effectiveness of the IPM program.

  • 4.11.1.5 Unless prohibited by regulation, interior monitoring devices include:
    -Mechanical traps
    -Extended trigger traps
    -Glue boards

  • 4.11.1.6 Facilities in countries that prohibit the use of mechanical traps may consider the use of alternative devices on a case-by-case basis. These devices may include:
    -Gassing traps (e.g., CO2) traps
    -Live catch traps
    -See-saw tubes
    -Electrocution traps
    -Extended trigger traps that send alert e-mails or text messages

  • 4.11.1.7 When non-toxic monitoring/tracking bait is used for interior monitoring, a documented proactive program is in place that defines frequency of inspections, identification of non-toxic bait placement, use according to label directions, and corrective actions plans for identification and tracking of resident pest populations and elimination of activity when detected.

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.

  • 4.12.1.2 Insect light traps are installed in a way that does not attract insects to the facility or open food.

  • 4.12.1.3 Service checks are performed on all units on a weekly basis during the active season and on a monthly basis during colder seasons or as dictated by climate and activity rates. These checks include:
    -Emptying collection devices
    -Cleaning the units
    -Repairs
    -Checks for tube breakage

  • 4.12.1.4 Shatter-resistant lights are used in all units located in raw materials and production areas. Other lights are managed in the facility's Glass, Brittle Plastics, and Ceramics Program.

  • 4.12.1.5 All services provided to light traps are documented.

  • 4.12.1.6 Insect light traps are used to monitor flying insect activity at locations identified by the annual IPM assessment.

  • 4.12.1.7 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.

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.

  • 4.13.1.2 Pheromone monitoring devices are inspected on a defined frequency.

  • 4.13.1.3 The facility documents the types and quantities of insects found during device inspections and uses the information to identify and eliminate the source of activity.

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

  • 4.14.1.2 Avicides are used only if legal.

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.

  • 4.16.1.2 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.

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