SQFI Animal Product Manufacturing Checklist

Use this SQF Animal Product Manufacturing Checklist Edition 9 to perform internal audits and/or gap assessments to implement your SQF-compliant operations, or in preparation of your SQFI (Safe Quality Food Institute) certification. Auditors inspect the site environment and local activities to identify risks that could adversely impact the safety of the product.​

SQFI Animal Product Manufacturing Checklist



General Information

1. Opening Meeting - People Present at the Opening Meeting (Please list names and roles in the following format Name: Role separated by comas)


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2. Closing Meeting - People Present at the Closing Meeting (Please list names and roles in the following format Name: Role separated by comas)


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3. Facility Description - Auditor Description of Facility (Please provide facility description include # of employees, size, production schedule, general layout, and any additional pertinent details


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4. Auditor Recommendation


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Management Commitment - Management Responsibility (Mandatory)

1. Senior site management shall prepare and implement a policy statement that outlines at a minimum the commitment of all site management to: i. Supply safe food;


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2. Senior site management shall prepare and implement a policy statement that outlines at a minimum the commitment of all site management to: ii. Establish and maintain a food safety culture within the site;


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3. Senior site management shall prepare and implement a policy statement that outlines at a minimum the commitment of all site management to: iii. Establish and continually improve the site’s food safety management system; and


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4. Senior site management shall prepare and implement a policy statement that outlines at a minimum the commitment of all site management to: iv. Comply with customer and regulatory requirements to supply safe food.


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5. Senior site management shall prepare and implement a policy statement that outlines at a minimum the commitment of all site management to: The policy statement shall be: v. Signed by the senior site manager and displayed in prominent positions; and


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6. Senior site management shall prepare and implement a policy statement that outlines at a minimum the commitment of all site management to: The policy statement shall be: vi. Effectively communicated to all site personnel in the language(s) understood by all site personnel.


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7. Senior site management shall lead and support a food safety culture within the site that ensures at a minimum: i. The establishment, documentation, and communication to all relevant staff of food safety objectives and performance measures;


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8. Senior site management shall lead and support a food safety culture within the site that ensures at a minimum: ii. Adequate resources are available to meet food safety objectives;


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9. Senior site management shall lead and support a food safety culture within the site that ensures at a minimum: iii. Food safety practices and all applicable requirements of the SQF System are adopted and maintained;


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10. Senior site management shall lead and support a food safety culture within the site that ensures at a minimum: iv. Staff are informed and held accountable for their food safety and regulatory responsibilities;


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11. Senior site management shall lead and support a food safety culture within the site that ensures at a minimum: v. Staff are positively encouraged and required to notify management about actual or potential food safety issues; and


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12. Senior site management shall lead and support a food safety culture within the site that ensures at a minimum: vi. Staff are empowered to act to resolve food safety issues within their scope of work.


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13. The reporting structure shall identify and describe site personnel with specific responsibilities for tasks within the food safety management system and identify a backup for the absence of key personnel. Job descriptions for the key personnel shall be documented. Site management shall ensure departments and operations are appropriately staffed and organizationally aligned to meet food safety objectives.


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14. Senior site management shall designate a primary and substitute SQF practitioner for each site with responsibility and authority to: i. Oversee the development, implementation, review, and maintenance of the SQF System;


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15. Senior site management shall designate a primary and substitute SQF practitioner for each site with responsibility and authority to: ii. Take appropriate action to ensure the integrity of the SQF System; and


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16. Senior site management shall designate a primary and substitute SQF practitioner for each site with responsibility and authority to: iii. Communicate to relevant personnel all information essential to ensure the effective implementation and maintenance of the SQF System.


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17. The primary and substitute SQF practitioner shall: i. Be employed by the site;


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18. The primary and substitute SQF practitioner shall: ii. Hold a position of responsibility related to the management of the site’s SQF System;


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19. The primary and substitute SQF practitioner shall: iii. Have completed a HACCP training course;


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20. The primary and substitute SQF practitioner shall: iv. Be competent to implement and maintain HACCP-based food safety plans; and


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21. The primary and substitute SQF practitioner shall: v. Have an understanding of the SQF Food Safety Code: Animal Product Manufacturing and the requirements to implement and maintain an SQF System relevant to the site’s scope of certification.


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22. Senior site management shall ensure the training needs of the site are resourced, implemented, and meet the requirements outlined in system elements 2.9, and that site personnel meet the required competencies to carry out those functions affecting the legality and safety of food products.


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23. Senior site management shall ensure the integrity and continued operation of the food safety system in the event of organizational or personnel changes within the company or associated facilities.


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24. Senior site management shall designate defined blackout periods that prevent unannounced re-certification audits from occurring out of season or when the site is not operating for legitimate business reasons. The list of blackout dates and their justification shall be submitted to the certification body a minimum of one (1) month before the sixty (60) day re-certification window for the agreed-upon unannounced audit.


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Management Commitment - Management Review (Mandatory)

1. The SQF System shall be reviewed by senior site management at least annually and include: i. Changes to food safety management system documentation (policies, procedures, specifications, food safety plan);


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2. The SQF System shall be reviewed by senior site management at least annually and include: ii. Food safety culture performance;


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3. The SQF System shall be reviewed by senior site management at least annually and include: iii. Food safety objectives and performance measures;


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4. The SQF System shall be reviewed by senior site management at least annually and include: iv. Corrective and preventative actions and trends in findings from internal and external audits, customer complaints, and verification and validation activities;


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5. The SQF System shall be reviewed by senior site management at least annually and include: v. Hazard and risk management system; and


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6. The SQF System shall be reviewed by senior site management at least annually and include: vi. Follow-up action items from previous management reviews. Records of all management reviews and updates shall be maintained.


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7. The SQF practitioner(s) shall update senior site management on at least a monthly basis on matters impacting the implementation and maintenance of the SQF System. The updates and management responses shall be documented.


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Management Commitment - Complaint Management (Mandatory)

1. The methods and responsibility for handling, investigating, and resolving food safety complaints from commercial customers, consumers, and authorities, arising from products manufactured or handled on-site or co-manufactured, shall be documented and implemented.


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2. Adverse trends of customer complaint data shall be investigated and analyzed and the root cause established by personnel knowledgeable about the incidents.


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3. Corrective and preventative action shall be implemented based on the seriousness of the incident and the root cause analysis as outlined in 2.5.3. Records of customer complaints, their investigation, and resolution shall be maintained.


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Document Control And Records - Food Safety Management System (Mandatory)

1. The methods and procedures the site uses to meet the requirements of the SQF Food Safety Code: Animal Product Manufacturing shall be maintained in electronic and/or hard copy documentation. They will be made available to relevant staff and include: i. A summary of the organization’s food safety policies and the methods it will apply to meet the requirements of this standard;


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2. The methods and procedures the site uses to meet the requirements of the SQF Food Safety Code: Animal Product Manufacturing shall be maintained in electronic and/or hard copy documentation. They will be made available to relevant staff and include: ii. The food safety policy statement and organization chart;


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3. The methods and procedures the site uses to meet the requirements of the SQF Food Safety Code: Animal Product Manufacturing shall be maintained in electronic and/or hard copy documentation. They will be made available to relevant staff and include: iii. The processes and products included in the scope of certification;


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4. The methods and procedures the site uses to meet the requirements of the SQF Food Safety Code: Animal Product Manufacturing shall be maintained in electronic and/or hard copy documentation. They will be made available to relevant staff and include: iv. Food safety regulations that apply to the manufacturing site and the country(ies) of sale (if known);


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5. The methods and procedures the site uses to meet the requirements of the SQF Food Safety Code: Animal Product Manufacturing shall be maintained in electronic and/or hard copy documentation. They will be made available to relevant staff and include: v. Raw material, ingredient, packaging, and finished product specifications;


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6. The methods and procedures the site uses to meet the requirements of the SQF Food Safety Code: Animal Product Manufacturing shall be maintained in electronic and/or hard copy documentation. They will be made available to relevant staff and include: vi. Food safety procedures, prerequisite programs, food safety plans;


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7. The methods and procedures the site uses to meet the requirements of the SQF Food Safety Code: Animal Product Manufacturing shall be maintained in electronic and/or hard copy documentation. They will be made available to relevant staff and include: vii. Process controls that impact product safety; and


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8. The methods and procedures the site uses to meet the requirements of the SQF Food Safety Code: Animal Product Manufacturing shall be maintained in electronic and/or hard copy documentation. They will be made available to relevant staff and include: viii. Other documentation necessary to support the development, implementation, maintenance, and control of the SQF System.


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9. Food safety plans, Good Manufacturing Practices, and all relevant aspects of the SQF System shall be reviewed, updated, and communicated as needed when any changes implemented have an impact on the site’s ability to deliver safe food. All changes to food safety plans, Good Manufacturing Practices, and other aspects of the SQF System shall be validated or justified prior to their implementation. The reasons for the change shall be documented.


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Document Control And Records - Document Control (Mandatory)

1. The methods and responsibility for maintaining document control and ensuring staff have access to current requirements and instructions shall be documented and implemented. Current SQF System documents and amendments to documents shall be maintained.


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Document Control And Records - Records (Mandatory)

1. The methods, frequency, and responsibility for verifying, maintaining, and retaining records shall be documented and implemented.


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2. All records shall be legible and confirmed by those undertaking monitoring activities that demonstrate inspections, analyses, and other essential activities that have been completed.


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3. Records shall be readily accessible, retrievable, and securely stored to prevent unauthorized access, loss, damage, and deterioration. Retention periods shall be in accordance with customer, legal, and regulatory requirements, at minimum the product shelf-life, or established by the site if no shelf-life exists.


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Specification, Formulations, Realization, And Supplier Approval - Product Formulation And Realization

1. The methods and responsibility for designing and developing new product formulations and converting product concepts to commercial realization shall be documented and implemented.


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2. New product formulations, manufacturing processes, and the fulfillment of product requirements shall be established, validated, and verified by site trials and product testing as required to ensure product safety. Product formulations shall be developed by authorized persons to ensure that they meet the intended use. Where necessary, shelf life trials shall be conducted to validate and verify a new product’s: i. Pre-consumer handling and storage requirements, including the establishment of “use by,” “best before dates,” or equivalent terminology;


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3. New product formulations, manufacturing processes, and the fulfillment of product requirements shall be established, validated, and verified by site trials and product testing as required to ensure product safety. Product formulations shall be developed by authorized persons to ensure that they meet the intended use. Where necessary, shelf life trials shall be conducted to validate and verify a new product’s: ii. Microbiological criteria, where applicable; and


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4. New product formulations, manufacturing processes, and the fulfillment of product requirements shall be established, validated, and verified by site trials and product testing as required to ensure product safety. Product formulations shall be developed by authorized persons to ensure that they meet the intended use. Where necessary, shelf life trials shall be conducted to validate and verify a new product’s: iii. Consumer preparation, where applicable, and storage and handling requirements.


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5. A food safety plan shall be validated and verified by the site food safety team for each new product and its associated process through conversion to commercial production and distribution or where a change to ingredients, process, or packaging occurs that may impact food safety.


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6. Product formulations and manufacturing processes for products included in the scope of certification shall be reviewed when there are changes in materials, ingredients, or equipment.


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7. The process flows for all new and existing manufacturing processes shall be designed to ensure that product is manufactured according to approved product formulations and to prevent cross-contamination.


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8. Records of product design, formulations, label compliance, process flows, shelf life trials, and approvals for all new and existing products shall be maintained.


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Specification, Formulations, Realization, And Supplier Approval - Specifications

1. The methods and responsibility for developing, managing, and approving raw material, finished product, and packaging specifications shall be documented.


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2. Specifications for all raw materials and packaging, including, but not limited to, ingredients, additives, hazardous chemicals, processing aids, and packaging that impact finished product safety shall be documented and kept current.


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3. All raw materials, packaging, and ingredients, including those received from other sites under the same corporate ownership, shall comply with specifications and with the relevant legislation in the country of manufacture and country(ies) of destination if known.


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4. Raw materials, packaging, and ingredients shall be validated to ensure product safety is not compromised and the material is fit for its intended purpose.


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5. Site management shall require approved raw materials suppliers to notify the site of changes in product composition that could have an impact on product formulation (e.g., protein content, moisture, amino acid profiles, contaminant levels, allergens, and/or other parameters that may be variable by season).


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6. Verification of packaging shall include a certification of all packaging that comes into direct contact with food meets either regulatory acceptance or approval criteria. Documentation shall either be in the form of a declaration of continued guarantee of compliance, a certificate of conformance, or a certificate from the applicable regulatory agency. In the absence of a certificate of conformance, certificate of analysis, or letter of guarantee, analyses to confirm the absence of potential chemical migration from the packaging to the food contents shall be conducted and records maintained.


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7. Finished product labels shall be accurate, comply with the relevant legislation, and be approved by qualified company personnel.


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8. Description of services for contract service providers that have an impact on product safety shall be documented, current, include a full description of the services to be provided, and detail relevant training requirements for all contract personnel.


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9. Finished product specifications shall be documented, current, approved by the site and its customer, accessible to relevant staff, and shall include, where applicable: i. Microbiological, chemical, and physical limits;


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10. Finished product specifications shall be documented, current, approved by the site and its customer, accessible to relevant staff, and shall include, where applicable: ii. Composition to meet label claims;


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11. Finished product specifications shall be documented, current, approved by the site and its customer, accessible to relevant staff, and shall include, where applicable: iii. Labeling and packaging requirements; and


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12. Finished product specifications shall be documented, current, approved by the site and its customer, accessible to relevant staff, and shall include, where applicable: iv. Storage conditions.


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13. Specifications for raw materials and packaging, chemicals, processing aids, contract services, and finished products shall be reviewed as changes occur that impact product safety. Records of reviews shall be maintained. A list of all the above specifications shall be maintained and kept current


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Specification, Formulations, Realization, And Supplier Approval - Contract Manufacturers

1. The methods and responsibility for ensuring all agreements with contract manufacturers relating to food safety, customer product requirements, their realization, and delivery shall be documented and implemented.


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2. The site shall establish a method to determine the food safety risk level of contract manufactured product and shall document the risk. The site shall ensure that: i. Products and processes of co-manufacturers that are considered high-risk have undergone an audit by the site or third-party agency to confirm compliance with the SQF Food Safety Code: Animal Product Manufacturing and regulatory and customer requirements;


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3. The site shall establish a method to determine the food safety risk level of contract manufactured product and shall document the risk. The site shall ensure that: ii. Products and processes of co-manufacturers that are considered low risk meet the requirements of the SQF Food Safety Code: Animal Product Manufacturing, or other GFSI benchmarked certification programs, and regulatory and customer requirements; and


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4. The site shall establish a method to determine the food safety risk level of contract manufactured product and shall document the risk. The site shall ensure that: iii. Changes to contractual agreements are approved by both parties and communicated to relevant personnel.


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5. Contractual agreements with third-party storage and distribution businesses shall include requirements relating to customer product requirements and compliance with clause 2.3.3.2 of the SQF Food Safety Code: Animal Product Manufacturing. Contractual agreements shall be approved by both parties and communicated to relevant personnel. The site shall verify compliance with the SQF Code and ensure that customer and regulatory requirements are being met at all times.


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6. Records of audits, contracts, and changes to contractual agreements and their approvals shall be maintained.


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Specification, Formulations, Realization, And Supplier Approval - Approved Supplier Program (Mandatory)

1. The responsibility and procedure for selecting, evaluating, approving, and monitoring an approved supplier shall be documented and implemented. A current record of approved suppliers, receiving inspections, and supplier audits shall be maintained.


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2. The approved supplier program shall be based on the past performance of a supplier and the risk level of the raw materials, ingredients, processing aids, packaging, and services supplied, and shall contain at a minimum: i. Agreed specifications (refer to 2.3.2); ii. Reference to the level of risk applied to raw materials, ingredients, packaging, and services from the approved supplier; iii. A summary of the food safety controls implemented by the approved supplier; iv. Methods for granting approved supplier status; v. Methods and frequency of monitoring approved suppliers; vi. Details of the certificates of conformance, if required; and vii. Methods and frequency of reviewing approved supplier performance and status.


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3. Verification of raw materials shall include certificates of conformance, certificates of analysis, or sampling, and testing. The verification frequency shall be identified by the site.


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4. The receipt of raw materials, ingredients, processing aids, and packaging from nonapproved suppliers shall be acceptable only in an emergency situation and provided a receiving inspection or analysis is conducted and recorded before use.


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5. Raw materials, ingredients, and packaging received from other sites under the same corporate ownership shall be subject to the same specification requirements (refer to 2.3.2), approved supplier requirements, and receiving inspections as all other material providers.


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6. Supplier audits shall be based on risk (as determined in 2.3.4.2) and shall be conducted by individuals knowledgeable of applicable regulatory and food safety requirements and trained in auditing techniques.


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Food Safety System - Food Legislation (Mandatory)

1. The site shall ensure that at the time of delivery to customers finished products comply with food safety legislation applicable in the country of manufacture and sale. This includes compliance with legislative requirements applicable to maximum residue limits, food safety, packaging, product description, net weights, nutritional, allergen, and additive labeling, labeling of identity preserved foods, any other criteria listed under food legislation, and to relevant established industry codes of practice.


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2. The methods and responsibility for ensuring the site is kept informed of changes to relevant legislation, scientific and technical developments, emerging food safety issues, and relevant industry codes of practice shall be documented and implemented.


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3. SQFI and the certification body shall be notified in writing within twenty-four (24) hours as a result of a regulatory warning or event. Notification to SQFI shall be by email to foodsafetycrisis@sqfi.com.


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Food Safety System - Good Manufacturing Practices (Mandatory)

1. The site shall ensure the applicable Good Manufacturing Practices described in module 9 of this Food Safety Code are applied or exempted according to a written risk analysis outlining the justification for exemption or evidence of the effectiveness of alternative control measures that ensure food safety is not compromised.


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2. The Good Manufacturing Practices applicable to the scope of certification outlining how food safety is controlled and assured shall be documented and implemented.


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Food Safety System - Food Safety Plan (Mandatory)

1. A food safety plan shall be prepared in accordance with the twelve steps identified in the Codex Alimentarius Commission HACCP guidelines. The food safety plan shall be effectively implemented and maintained and shall outline how the site controls and assures food safety of the products or product groups included in the scope of the SQF certification and their associated processes. More than one HACCP food safety plan may be required to cover all products included in the scope of certification.


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2. The food safety plan or plans shall be developed and maintained by a multidisciplinary team that includes the SQF practitioner and those site personnel with technical, production, and engineering knowledge of the relevant raw materials, packaging materials, processing aids, products, and associated processes. Where the relevant expertise is not available on-site, advice may be obtained from other sources to assist the food safety team.


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3. The scope of each food safety plan shall be developed and documented including the start and end points of the processes under consideration and all relevant inputs and outputs.


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4. Product descriptions shall be developed and documented for all products included in the scope of the food safety plans. The descriptions shall reference the finished product specifications (refer to 2.3.2.9) plus any additional information relevant to product safety, such as pH, water activity, composition, and/or storage conditions.


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5. The intended use of each product shall be determined and documented by the food safety team. This shall include target consumer groups, the potential for consumption by vulnerable groups of the population, requirements for further processing if applicable, and potential alternative uses of the product.


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6. The food safety team shall develop and document a flow diagram covering the scope of each food safety plan The flow diagram shall include every step in the process, all raw materials, packaging materials, service inputs (e.g., water, steam, gasses as applicable), scheduled process delays, and all process outputs including waste and rework. Each flow diagram shall be confirmed by the food safety team to cover all stages and hours of operation.


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7. The food safety team shall identify and document all food safety hazards that can reasonably be expected to occur at each step in the processes, including raw materials and other inputs.


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8. The food safety team shall conduct a hazard analysis for every identified hazard to determine which hazards are significant, i.e., their elimination or reduction to an acceptable level is necessary to control food safety. The methodology for determining hazard significance shall be documented and used consistently to assess all potential hazards.


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9. The food safety team shall determine and document the control measures that must be applied to all significant hazards. More than one control measure may be required to control an identified hazard, and more than one significant hazard may be controlled by a specific control measure.


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10. Based on the results of the hazard analysis (refer to 2.4.3.8), the food safety team shall identify the steps in the process where control must be applied to eliminate a significant hazard or reduce it to an acceptable level (i.e., a critical control point or CCP). In instances where a significant hazard has been identified at a step in the process, but no control measure exists, the food safety team shall modify the process to include an appropriate control measure.


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11. For each identified CCP, the food safety team shall identify and document the limits that separate safe from unsafe product (critical limits). The food safety team shall validate all of the critical limits to ensure the level of control of the identified food safety hazard (s) and that all critical limits and control measures individually or in combination effectively provide the level of control required (refer to 2.5.2.1).


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12. The food safety team shall develop and document procedures to monitor CCPs to ensure they remain within the established limits (refer to 2.4.3.11). Monitoring procedures shall identify the personnel assigned to conduct monitoring, the sampling and test methods, and the test frequency.


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13. The food safety team shall develop and document deviation procedures that identify the disposition of affected product when monitoring indicates a loss of control at a CCP. The procedures shall also prescribe actions to correct the process step to prevent recurrence of the safety failure.


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14. The documented and approved food safety plan (s) shall be implemented in full. The effective implementation shall be monitored by the food safety team, and a full review of the documented and implemented plans shall be conducted at least annually, or when changes to the process, equipment, inputs, or other changes affecting product safety occur.


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15. Procedures shall be in place to verify that critical control points are effectively monitored and appropriate corrective actions are applied. Implemented food safety plans shall be verified as part of SQF System verification (refer to 2.5).


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16. Critical control point monitoring, corrective action, and verification records shall be maintained and appropriately used.


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17. Where food safety regulations in the country of production and destination (if known) prescribe a food safety control methodology other than the Codex Alimentarius Commission HACCP guidelines, the food safety team shall implement food safety plans that meet both Codex and food regulatory requirements.


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Food Safety System - Product Sampling, Inspection, And Analysis

1. The methods, responsibility, and criteria for sampling, inspecting, and/or analyzing raw materials, work-in- progress, and finished product shall be documented and implemented. The methods applied shall ensure that inspections and analyses are completed at regular intervals as required and to agreed specifications and legal requirements. Sampling and testing shall be representative of the process batch and ensure that process controls are maintained to meet specification and formulation.


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2. Product analyses shall be conducted to nationally recognized methods, or company requirements or alternative methods that are validated as equivalent to the nationally recognized methods. Where internal laboratories are used to conduct input, environmental, or product analyses, sampling and testing methods shall be in accordance with the applicable requirements of ISO/IEC 17025, including annual proficiency testing for staff conducting analyses. External laboratories shall be accredited to ISO/IEC 17025, or an equivalent international standard, and included on the site’s contract service specifications list (refer to 2.3.2.11).


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3. On-site laboratories conducting chemical and microbiological analyses that may pose a risk to product safety shall be located separate from any food processing or handling activity and designed to limit access only to authorized personnel. Signage shall be displayed identifying the laboratory area as a restricted area, accessible only by authorized personnel.


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4. Provisions shall be made to isolate and contain all hazardous laboratory waste held on the premises and manage it separately from food waste. Laboratory waste outlets shall at a minimum be downstream of drains that service food processing and handling areas.


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5. Retention samples, if required by customers or regulations, shall be stored according to the typical storage conditions for the product and maintained for the stated shelf life of the product.


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6. Records of all inspections and analyses shall be maintained.


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Food Safety System - Non-conforming Materials And Product

1. The responsibility and methods outlining how to handle non-conforming product, raw material, ingredient, work-in-progress, or packaging, which is detected during receipt, storage, processing, handling, or delivery, shall be documented and implemented. The methods applied shall ensure: i. Non-conforming product is quarantined, identified, handled, and/or disposed of in a manner that minimizes the risk of inadvertent use, improper use, or risk to the integrity of finished product; and


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2. The responsibility and methods outlining how to handle non-conforming product, raw material, ingredient, work-in-progress, or packaging, which is detected during receipt, storage, processing, handling, or delivery, shall be documented and implemented. The methods applied shall ensure: ii. All relevant personnel are aware of the organization’s quarantine and release requirements applicable to product placed under quarantine status.


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3. Quarantine records and records of the handling, corrective action, or disposal of nonconforming materials or product shall be maintained.


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Food Safety System - Product Rework

1. The responsibility and methods outlining how ingredients, packaging, or products are reworked shall be documented and implemented. The methods applied shall ensure: i. Reworking operations are overseen by qualified personnel;


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2. The responsibility and methods outlining how ingredients, packaging, or products are reworked shall be documented and implemented. The methods applied shall ensure: ii. Reworked product is clearly identified and traceable;


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3. The responsibility and methods outlining how ingredients, packaging, or products are reworked shall be documented and implemented. The methods applied shall ensure: iii. Reworked product is processed in accordance with the site’s food safety plan;


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4. The responsibility and methods outlining how ingredients, packaging, or products are reworked shall be documented and implemented. The methods applied shall ensure: iv. Each batch of reworked product is inspected or analyzed as required before release;


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5. The responsibility and methods outlining how ingredients, packaging, or products are reworked shall be documented and implemented. The methods applied shall ensure: v. Inspections and analyses conform to the requirements outlined in element 2.4.4.1;


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6. The responsibility and methods outlining how ingredients, packaging, or products are reworked shall be documented and implemented. The methods applied shall ensure: vi. Release of reworked product conforms to element 2.4.7; and


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7. The responsibility and methods outlining how ingredients, packaging, or products are reworked shall be documented and implemented. The methods applied shall ensure: vii. Reworked product does not affect the safety or integrity of the finished product. Records of all reworking operations shall be maintained.


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Food Safety System - Product Release (Mandatory)

1. The responsibility and methods for releasing products shall be documented and implemented. The methods applied shall ensure the product is released by authorized personnel, and only after all inspections and analyses are successfully completed and documented to verify legislative and other established food safety controls have been met. Records of all product releases shall be maintained.


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2. Product release shall include a procedure to confirm that product labels comply with the food legislation that applies in the country of manufacture and the country(ies) of use or sale if known (refer to 2.4.1.1). If product is packaged and distributed in bulk or unlabeled, product information shall be made available to inform customers and/or consumers of the requirements for its safe use.


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3. In the event that the site uses positive release based on product pathogen or chemical testing, a procedure shall be in place to ensure that product is not released until acceptable results have been received. In the event that off-site or contract warehouses are used, these requirements shall be effectively communicated and verified as being followed.


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Food Safety System - Environmental Monitoring

1. A risk-based environmental monitoring program shall be in place for all food manufacturing processes and immediate surrounding areas, which impact manufacturing processes. The responsibility and methods for the environmental monitoring program shall be documented and implemented.


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2. An environmental sampling and testing schedule shall be prepared. It shall at a minimum: i. Detail the applicable pathogens or indicator organisms to test for in that industry;


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3. An environmental sampling and testing schedule shall be prepared. It shall at a minimum: ii. List the number of samples to be taken and the frequency of sampling;


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4. An environmental sampling and testing schedule shall be prepared. It shall at a minimum: iii. Outline the locations in which samples are to be taken and the rotation of locations as needed; and


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5. An environmental sampling and testing schedule shall be prepared. It shall at a minimum: iv. Describe the methods to handle elevated or undesirable results.


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6. Environmental testing results shall be monitored, tracked, and trended, and preventative actions (refer to 2.5.3.1) shall be implemented where unsatisfactory results or trends are observed.


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SQF System Verification - Validation And Effectiveness (Mandatory)

1. The methods, responsibility, and criteria for ensuring the effectiveness of all applicable elements of the SQF Program shall be documented and implemented. The methods applied shall ensure that: i. Good Manufacturing Practices are confirmed to ensure they achieve the required results;


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2. The methods, responsibility, and criteria for ensuring the effectiveness of all applicable elements of the SQF Program shall be documented and implemented. The methods applied shall ensure that: ii. Critical food safety limits are reviewed annually and re-validated or justified by regulatory standards when changes occur; and


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3. The methods, responsibility, and criteria for ensuring the effectiveness of all applicable elements of the SQF Program shall be documented and implemented. The methods applied shall ensure that: iii. Changes to the processes or procedures are assessed to ensure the controls are still effective. Records of all validation activities shall be maintained.


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SQF System Verification - Verification Activities (Mandatory)

1. The methods, responsibility, and criteria for verifying monitoring of Good Manufacturing Practices, critical control points, and other food safety controls, and the legality of certified products shall be documented and implemented. The methods applied shall ensure that personnel with responsibility for verifying monitoring activities authorize each verified record.


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2. A schedule outlining the verification activities, their frequency of completion, and the person responsible for each activity shall be prepared and implemented. Records of verification of activities shall be maintained.


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SQF System Verification - Corrective And Preventative Action (Mandatory)

1. The responsibility and methods outlining how corrective and preventative actions are determined, implemented, and verified, including the identification of the root cause and resolution of non-compliance of critical food safety limits and deviations from food safety requirements, shall be documented and implemented. Deviations from food safety requirements may include customer complaints, nonconformances raised at internal or external audits and inspections, non-conforming product and equipment, withdrawals and recalls, as appropriate.


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2. Records of all investigation, root cause analysis, and resolution of non-conformities, their corrections, and the implementation of preventative actions shall be maintained.


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SQF System Verification - Internal Audits And Inspections (Mandatory)

1. The methods and responsibility for scheduling and conducting internal audits to verify the effectiveness of the SQF System shall be documented and implemented. Internal audits shall be conducted in full and at least annually. The methods applied shall ensure: i. All applicable requirements of the SQF Food Safety Code: Animal Product Manufacturing are audited per the SQF audit checklist or a similar tool;


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2. The methods and responsibility for scheduling and conducting internal audits to verify the effectiveness of the SQF System shall be documented and implemented. Internal audits shall be conducted in full and at least annually. The methods applied shall ensure: ii. Objective evidence is recorded to verify compliance and/or non-compliance;


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3. The methods and responsibility for scheduling and conducting internal audits to verify the effectiveness of the SQF System shall be documented and implemented. Internal audits shall be conducted in full and at least annually. The methods applied shall ensure: iii. Corrective and preventative actions of deficiencies identified during the internal audits are undertaken; and


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4. The methods and responsibility for scheduling and conducting internal audits to verify the effectiveness of the SQF System shall be documented and implemented. Internal audits shall be conducted in full and at least annually. The methods applied shall ensure: iv. Audit results are communicated to relevant management personnel and staff responsible for implementing and verifying corrective and preventative actions.


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5. Staff conducting internal audits shall be trained and competent in internal audit procedures. Where practical, staff conducting internal audits shall be independent of the function being audited.


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6. Regular inspections of the site and equipment shall be planned and carried out to verify Good Manufacturing Practices and facility and equipment maintenance are compliant to the SQF Food Safety Code: Animal Product Manufacturing. The site shall: i. Take corrections or corrective and preventative action; and


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7. Regular inspections of the site and equipment shall be planned and carried out to verify Good Manufacturing Practices and facility and equipment maintenance are compliant to the SQF Food Safety Code: Animal Product Manufacturing. The site shall: ii. Maintain records of inspections and any corrective actions taken


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8. Records of internal audits and inspections and any corrective and preventative actions taken as a result of internal audits shall be recorded as per 2.5.3. Changes implemented from internal audits that have an impact on the site’s ability to deliver safe food shall require a review of applicable aspects of the SQF System (refer to 2.3.1.3).


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Product Traceability And Crisis Management - Product Identification (Mandatory)

1. The methods and responsibility for identifying raw materials, ingredients, packaging, work-in-progress, process inputs, and finished products during all stages of production and storage shall be documented and implemented to ensure: i. Raw materials, ingredients, packaging, work-in-progress, process inputs, and finished products are clearly identified during all stages of receipt, production, storage, and dispatch; and


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2. The methods and responsibility for identifying raw materials, ingredients, packaging, work-in-progress, process inputs, and finished products during all stages of production and storage shall be documented and implemented to ensure: ii. Finished product is labeled to the customer specification and/or regulatory requirements.


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3. Product start-up, product changeover, and packaging changeover (including label changes) procedures shall be documented and implemented to ensure that the correct product is in the correct package and with the correct label and that the changeover is inspected and approved by an authorized person. Procedures shall be implemented to ensure that label use is reconciled and any inconsistencies investigated and resolved. Product changeover and label reconciliation records shall be maintained.


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Product Traceability And Crisis Management - Product Trace (Mandatory)

1. The responsibility and methods used to trace product shall be documented and implemented to ensure: i. Finished product is traceable at least one step forward to the customer and at least one step back from the process to the manufacturing supplier;


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2. The responsibility and methods used to trace product shall be documented and implemented to ensure: ii. The receipt dates of raw materials, ingredients, food contact packaging, and materials and other inputs are recorded (refer to 2.8.1.8 for traceback of allergen containing food products);


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3. The responsibility and methods used to trace product shall be documented and implemented to ensure: iii. Traceability is maintained where product is reworked (refer to 2.4.6); and


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4. The responsibility and methods used to trace product shall be documented and implemented to ensure: iv. The effectiveness of the product trace system is reviewed at least annually as part of the product recall and withdrawal review (refer to 2.6.3.2). Records of raw and packaging material receipt and use and finished product dispatch and destination shall be maintained.


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Product Traceability And Crisis Management - Product Withdrawal And Recall (Mandatory)

1. The responsibility and methods used to withdraw or recall product shall be documented and implemented. The procedure shall: i. Identify those responsible for initiating, managing, and investigating a product withdrawal or recall; Describe the management procedures to be implemented, including sources of legal, regulatory, and expert advice, and essential traceability information;


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2. The responsibility and methods used to withdraw or recall product shall be documented and implemented. The procedure shall: ii. Outline a communication plan to inform site personnel, customers, consumers, authorities, and other essential bodies in a timely manner appropriate to the nature of the incident; and


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3. The responsibility and methods used to withdraw or recall product shall be documented and implemented. The procedure shall: iii. Ensure that SQFI, the certification body, and the appropriate regulatory authority are listed as essential organizations and notified in instances of a food safety incident of a public nature or product recall for any reason.


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4. The product withdrawal and recall system shall be reviewed, tested, and verified as effective at least annually. Testing shall include incoming materials (minimum traceability one step back) and finished product (minimum traceability one step forward). Testing shall be carried out on products from different shifts and for materials (including bulk materials) that are used across a range of products and/or products that are shipped to a wide range of customers.


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5. Records shall be maintained of withdrawal and recall tests, root cause investigations into actual withdrawals and recalls, and corrective and preventative actions applied.


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6. SQFI and the certification body shall be notified in writing within twenty-four (24) hours upon identification of a food safety event that requires public notification. SQFI shall be notified at foodsafetycrisis@sqfi.com.


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Product Traceability And Crisis Management - Crisis Management Planning

1. A crisis management plan based on the understanding of known potential dangers (e.g., flood, drought, fire, tsunami, or other severe weather events, warfare or civil unrest, computer outage, pandemic, loss of electricity or refrigeration, ammonia leak, labor strike) that can impact the site’s ability to deliver safe food shall be documented by senior management, outlining the methods and responsibility the site shall implement to cope with such a business crisis. The crisis management plan shall include at a minimum: i. A senior manager responsible for decision making, oversight, and initiating actions arising from a crisis management incident;


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2. A crisis management plan based on the understanding of known potential dangers (e.g., flood, drought, fire, tsunami, or other severe weather events, warfare or civil unrest, computer outage, pandemic, loss of electricity or refrigeration, ammonia leak, labor strike) that can impact the site’s ability to deliver safe food shall be documented by senior management, outlining the methods and responsibility the site shall implement to cope with such a business crisis. The crisis management plan shall include at a minimum: ii. The nomination and training of a crisis management team;


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3. A crisis management plan based on the understanding of known potential dangers (e.g., flood, drought, fire, tsunami, or other severe weather events, warfare or civil unrest, computer outage, pandemic, loss of electricity or refrigeration, ammonia leak, labor strike) that can impact the site’s ability to deliver safe food shall be documented by senior management, outlining the methods and responsibility the site shall implement to cope with such a business crisis. The crisis management plan shall include at a minimum: iii. The controls implemented to ensure any responses do not compromise product safety;


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4. A crisis management plan based on the understanding of known potential dangers (e.g., flood, drought, fire, tsunami, or other severe weather events, warfare or civil unrest, computer outage, pandemic, loss of electricity or refrigeration, ammonia leak, labor strike) that can impact the site’s ability to deliver safe food shall be documented by senior management, outlining the methods and responsibility the site shall implement to cope with such a business crisis. The crisis management plan shall include at a minimum: iv. The measures to isolate and identify product affected by a response to a crisis;


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5. A crisis management plan based on the understanding of known potential dangers (e.g., flood, drought, fire, tsunami, or other severe weather events, warfare or civil unrest, computer outage, pandemic, loss of electricity or refrigeration, ammonia leak, labor strike) that can impact the site’s ability to deliver safe food shall be documented by senior management, outlining the methods and responsibility the site shall implement to cope with such a business crisis. The crisis management plan shall include at a minimum: v. The measures taken to verify the acceptability of food prior to release;


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6. A crisis management plan based on the understanding of known potential dangers (e.g., flood, drought, fire, tsunami, or other severe weather events, warfare or civil unrest, computer outage, pandemic, loss of electricity or refrigeration, ammonia leak, labor strike) that can impact the site’s ability to deliver safe food shall be documented by senior management, outlining the methods and responsibility the site shall implement to cope with such a business crisis. The crisis management plan shall include at a minimum: vi. The preparation and maintenance of a current crisis alert contact list, including supply chain customers;


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7. A crisis management plan based on the understanding of known potential dangers (e.g., flood, drought, fire, tsunami, or other severe weather events, warfare or civil unrest, computer outage, pandemic, loss of electricity or refrigeration, ammonia leak, labor strike) that can impact the site’s ability to deliver safe food shall be documented by senior management, outlining the methods and responsibility the site shall implement to cope with such a business crisis. The crisis management plan shall include at a minimum: vii. Sources of legal and expert advice; and


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8. A crisis management plan based on the understanding of known potential dangers (e.g., flood, drought, fire, tsunami, or other severe weather events, warfare or civil unrest, computer outage, pandemic, loss of electricity or refrigeration, ammonia leak, labor strike) that can impact the site’s ability to deliver safe food shall be documented by senior management, outlining the methods and responsibility the site shall implement to cope with such a business crisis. The crisis management plan shall include at a minimum: viii. The responsibility for internal communications and communicating with authorities, external organizations, and media.


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9. The crisis management plan shall be reviewed, tested, and verified at least annually with gaps and appropriate corrective actions documented. Records of reviews of the crisis management plan shall be maintained.


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Food Defense And Food Fraud - Food Defense Plan (Mandatory)

1. A food defense threat assessment shall be conducted to identify potential threats that can be caused by a deliberate act of sabotage or terrorist-like incident.


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2. A food defense plan shall be documented, implemented, and maintained based on the threat assessment (refer to 2.7.1.1). The food defense plan shall meet legislative requirements as applicable and shall include at a minimum: i. The methods, responsibility, and criteria for preventing food adulteration caused by a deliberate act of sabotage or terrorist-like incident;


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3. A food defense plan shall be documented, implemented, and maintained based on the threat assessment (refer to 2.7.1.1). The food defense plan shall meet legislative requirements as applicable and shall include at a minimum: ii. The name of the senior site management person responsible for food defense;


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4. A food defense plan shall be documented, implemented, and maintained based on the threat assessment (refer to 2.7.1.1). The food defense plan shall meet legislative requirements as applicable and shall include at a minimum: iii. The methods implemented to ensure only authorized personnel have access to production equipment and vehicles, manufacturing, and storage areas through designated access points;


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5. A food defense plan shall be documented, implemented, and maintained based on the threat assessment (refer to 2.7.1.1). The food defense plan shall meet legislative requirements as applicable and shall include at a minimum: iv. The methods implemented to protect sensitive processing points from intentional adulteration;


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6. A food defense plan shall be documented, implemented, and maintained based on the threat assessment (refer to 2.7.1.1). The food defense plan shall meet legislative requirements as applicable and shall include at a minimum: v. The measures taken to ensure the secure receipt and storage of raw materials, ingredients, packaging, equipment, and hazardous chemicals to protect them from deliberate acts of sabotage or terrorist-like incidents;


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7. A food defense plan shall be documented, implemented, and maintained based on the threat assessment (refer to 2.7.1.1). The food defense plan shall meet legislative requirements as applicable and shall include at a minimum: vi. The measures implemented to ensure raw materials, ingredients, packaging (including labels), work-in-progress, process inputs, and finished products are held under secure storage and transportation conditions; and


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8. A food defense plan shall be documented, implemented, and maintained based on the threat assessment (refer to 2.7.1.1). The food defense plan shall meet legislative requirements as applicable and shall include at a minimum: vii. The methods implemented to record and control access to the premises by site personnel, contractors, and visitors.


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9. Instruction shall be provided to all relevant staff on the effective implementation of the food defense plan (refer to 2.9.2.1).


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10. The food defense threat assessment and prevention plan shall be reviewed and tested at least annually or when the threat level, as defined in the threat assessment, changes. Records of reviews and tests of the food defense plan shall be maintained.


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Food Defense And Food Fraud - Food Fraud (Mandatory)

1. The methods, responsibility, and criteria for identifying the site’s vulnerability to food fraud, including susceptibility to raw material or ingredient substitution, finished product mislabeling, dilution, or counterfeiting, shall be documented, implemented, and maintained.


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2. A food fraud mitigation plan shall be developed and implemented, that specifies the methods by which the identified food fraud vulnerabilities shall be controlled, including identified food safety vulnerabilities of ingredients and materials.


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3. Instruction shall be provided to all relevant staff on the effective implementation of the food fraud mitigation plan (refer to 2.9.2.1).


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4. The food fraud vulnerability assessment and mitigation plan shall be reviewed and verified at least annually with gaps and corrective actions documented. Records of reviews shall be maintained.


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Allergen Management - Allergen Management (Mandatory)

1. The responsibility and methods used to control allergens and to prevent sources of allergens from contaminating product shall be documented and implemented. The allergen management program shall include: i. A risk analysis of those raw materials, ingredients, and processing aids, including food-grade lubricants, that contain food allergens;


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2. The responsibility and methods used to control allergens and to prevent sources of allergens from contaminating product shall be documented and implemented. The allergen management program shall include: ii. An assessment of workplace-related food allergens that may originate from locker rooms, vending machines, lunchrooms, and visitors;


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3. The responsibility and methods used to control allergens and to prevent sources of allergens from contaminating product shall be documented and implemented. The allergen management program shall include: iii. A list of allergens that is applicable in the country of manufacture and the country(ies) of destination, if known;


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4. The responsibility and methods used to control allergens and to prevent sources of allergens from contaminating product shall be documented and implemented. The allergen management program shall include: iv. A list of allergens that is accessible to relevant staff;


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5. The responsibility and methods used to control allergens and to prevent sources of allergens from contaminating product shall be documented and implemented. The allergen management program shall include: v. The control of hazards associated with allergens and incorporated into the food safety plan, and


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6. The responsibility and methods used to control allergens and to prevent sources of allergens from contaminating product shall be documented and implemented. The allergen management program shall include: vi. Management plans for control of the identified allergens.


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7. Instructions shall be provided to all relevant staff involved in the receipt or handling of raw materials, work-in-progress, rework, or finished product on how to identify, handle, store, and segregate raw materials and products containing allergens.


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8. Provisions shall be made to clearly identify and segregate foods that contain allergens. Segregation procedures shall be implemented and continually monitored.


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9. Where allergenic material may be intentionally or unintentionally present, cleaning and sanitation of product contact surfaces between line changeovers shall be effective, appropriate to the risk and legal requirements, and sufficient to remove all potential target allergens from product contact surfaces, including aerosols as appropriate, to prevent cross-contact. Separate handling and production equipment shall be provided, where satisfactory line hygiene and clean-up or segregation are not possible.


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10. Based on risk assessment, procedures for validation and verification of the effectiveness of the cleaning and sanitation of areas and equipment in which allergens are used shall be documented and effectively implemented.


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11. Where allergenic material may be present, product changeover procedures shall be documented and implemented to eliminate the risk of cross-contact.


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12. The product identification system (refer to 2.6.1.1) shall make provision for clear identification and labeling, in accordance with the regulatory requirements, of those products produced on production lines and equipment on which foods containing allergens are manufactured.


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13. The product trace system (refer to 2.6.2) shall take into consideration the conditions under which allergen- containing foods are manufactured and ensure full traceback of all ingredients and processing aids used.


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14. The site shall document and implement methods to control the accuracy of finished product labels (or consumer information where applicable) and assure work-in progress and finished product are true to label with regard to allergens. Measures may include label approvals at receipt, label reconciliations during production, destruction of obsolete labels, verification of labels on finished product as appropriate, and product changeover procedures.


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15. Re-working of product (refer to 2.4.6) containing food allergens shall be conducted under conditions that ensure product safety and integrity are maintained. Re-worked product containing allergens shall be clearly identified and traceable.


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16. Sites that do not handle allergenic materials or produce allergenic products shall document, implement, and maintain an allergen management program addressing at a minimum the mitigation of introduced or unintended allergens through supplier, contract manufacturer, site personnel, and visitor activities.


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Training - Training Requirements

1. The responsibility for establishing and implementing the training needs of the organization’s personnel to ensure they have the required competencies to carry out those functions affecting products, legality, and safety shall be defined and documented (refer to 2.1.1.6)


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2. Appropriate training shall be provided for personnel carrying out the tasks essential to the effective implementation of the SQF System and the maintenance of food safety and regulatory requirements.


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Training - Training Program (Mandatory)

1. A training program shall be documented and implemented that, at a minimum, outlines the necessary competencies for specific duties and the training methods to be applied to personnel carrying out tasks associated with: i. Implementing HACCP for staff involved in developing and maintaining food safety plans;


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2. A training program shall be documented and implemented that, at a minimum, outlines the necessary competencies for specific duties and the training methods to be applied to personnel carrying out tasks associated with: ii. Monitoring and corrective action procedures for all staff engaged in monitoring critical control points (CCPs);


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3. A training program shall be documented and implemented that, at a minimum, outlines the necessary competencies for specific duties and the training methods to be applied to personnel carrying out tasks associated with: iii. Personal hygiene for all staff involved in the handling of food products and food contact surfaces;


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4. A training program shall be documented and implemented that, at a minimum, outlines the necessary competencies for specific duties and the training methods to be applied to personnel carrying out tasks associated with: iv. Good Manufacturing Practices and work instructions for all staff engaged in food handling, food processing, and equipment;


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5. A training program shall be documented and implemented that, at a minimum, outlines the necessary competencies for specific duties and the training methods to be applied to personnel carrying out tasks associated with: v. Sampling and test methods for all staff involved in sampling and testing of raw materials, packaging, work-in-progress, and finished products;


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6. A training program shall be documented and implemented that, at a minimum, outlines the necessary competencies for specific duties and the training methods to be applied to personnel carrying out tasks associated with: vi. Environmental monitoring for relevant staff;


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7. A training program shall be documented and implemented that, at a minimum, outlines the necessary competencies for specific duties and the training methods to be applied to personnel carrying out tasks associated with: vii. Allergen management, food defense, and food fraud for all relevant staff; and


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8. A training program shall be documented and implemented that, at a minimum, outlines the necessary competencies for specific duties and the training methods to be applied to personnel carrying out tasks associated with: viii. Tasks identified as critical to meeting the effective implementation and maintenance of the SQF Code. The training program shall include provisions for identifying and implementing the refresher training needs of the organization.


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9. Training materials, the delivery of training, and procedures on all tasks critical to meeting regulatory compliance and the maintenance of food safety shall be provided in language(s) understood by staff.


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10. Training records shall be maintained and include: i. Participant name;


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11. Training records shall be maintained and include: ii. Skills description;


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12. Training records shall be maintained and include: iii. Description of the training provided;


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13. Training records shall be maintained and include: iv. Date training completed;


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14. Training records shall be maintained and include: v. Trainer or training provider; and


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15. Training records shall be maintained and include: vi. Verification that the trainee is competent to complete the required tasks.


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Site Location And Premises - Premises Location, Construction, And Housing

1. The site shall assess local activities and the site environment to identify any risks that may have an adverse impact on product safety and implement controls for any identified risks. The assessment shall be reviewed in response to any changes in the local environment or activities. The construction and ongoing operation of the premises on the site shall be approved by the relevant authority.


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2. Pens, yards, and lairage shall be designed, located, constructed, and maintained to minimize stress, injury, or disease and have minimal impact on the surrounding area and natural resources. Fences, gates, and other surfaces in pens and yards shall be free from paints, dips, sanitizers, and other materials that are likely to cause contamination through ingestion, inhalation, or contact. They shall be designed so that liquid waste can drain away and be collected if required, and that aerial fecal contamination does not contaminate meat products.


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3. Laneways, races, entrances, exits, and loading/unloading ramps shall be: i. Designed to include consideration of the social behavior and movement of the species;


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4. Laneways, races, entrances, exits, and loading/unloading ramps shall be: ii. Designed and maintained to prevent potential injury points to the animals;


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5. Laneways, races, entrances, exits, and loading/unloading ramps shall be: iii. Free from sharp objects that may damage the animals; and


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6. Laneways, races, entrances, exits, and loading/unloading ramps shall be: iv. Free from chemicals other than those approved by the relevant authority for use on livestock


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Site Location And Premises - Building Materials

1. Floors shall be constructed of smooth, dense, impact-resistant material that can be effectively graded, drained, impervious to liquid, and easily cleaned. Floors shall be sloped to floor drains at gradients suitable to allow the effective removal of all overflow or wastewater under normal working conditions. Where floor drainage is not available, plumbed options to handle overflow or wastewater shall be in place.


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2. Drains shall be constructed and located so they can be easily cleaned and not present a hazard.


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3. Waste trap system shall be located away from any food handling areas or entrances to the premises.


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4. Walls, partitions, ceilings, and doors shall be of durable construction. Internal surfaces shall have an even and regular surface and be impervious with a light-colored finish and shall be kept clean (refer to 9.2.5). Wall-to-wall and wall-to-floor junctions shall be designed to be easily cleaned and sealed to prevent the accumulation of food debris.


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5. Ducting, conduit, and pipes that convey ingredients, products, or services such as steam or water, shall be designed and constructed to prevent the contamination of food, ingredients, and food contact surfaces and allow ease of cleaning. A risk analysis shall be conducted to ensure food contamination risks are mitigated.


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6. Pipes carrying sanitary waste or wastewater that are located directly over product lines or storage areas shall be designed and constructed to prevent the contamination of food, materials, ingredients, and food contact surfaces and shall allow ease of cleaning. A risk analysis shall be conducted to ensure food contamination risks are mitigated.


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7. Doors, hatches, and windows and their frames in food processing, handling, or storage areas shall be of a material and construction that meet the same functional requirements as for internal walls and partitions. Doors and hatches shall be of solid construction, and windows shall be made of shatterproof glass or similar material.


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8. Product shall be processed and handled in areas that are fitted with a ceiling or other acceptable structure that is constructed and maintained to prevent the contamination of products. Drop ceilings, where present, shall be constructed to enable monitoring for pest activity, facilitate cleaning, and provide access to utilities.


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9. Stairs, catwalks, and platforms in food processing and handling areas shall be designed and constructed so they do not present a product contamination risk and with no open grates directly above exposed food product surfaces. They shall be kept clean (refer to 9.2.5).


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Site Location And Premises - Lightings And Light Fittings

1. Lighting in food processing and handling areas and at inspection stations shall be of appropriate intensity to enable the staff to carry out their tasks efficiently and effectively and shall comply with local light-intensity regulations or industry standards.


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2. Light fixtures in processing areas, inspection stations, ingredient and packaging storage areas, and all areas where the product is exposed shall be shatterproof, manufactured with a shatterproof covering or fitted with protective covers, and recessed into or fitted flush with the ceiling. Where fixtures cannot be recessed, structures must be protected from accidental breakage, manufactured from cleanable materials, and addressed in the cleaning and sanitation program.


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3. Light fixtures in the warehouse or other areas where product is covered or otherwise protected shall be designed to prevent breakage and product contamination.


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Site Location And Premises - Inspection / Quality Control Area

1. If online inspection is required, a suitable area close to the processing line shall be provided for the inspection of product (refer to 2.4.4). The inspection/quality control area shall be provided with facilities that are suitable for examination and testing of the type of product being handled/processed. The inspection area shall: i. Have easy access to handwashing facilities;


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2. If online inspection is required, a suitable area close to the processing line shall be provided for the inspection of product (refer to 2.4.4). The inspection/quality control area shall be provided with facilities that are suitable for examination and testing of the type of product being handled/processed. The inspection area shall: ii. Have appropriate waste handling and removal; and


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3. If online inspection is required, a suitable area close to the processing line shall be provided for the inspection of product (refer to 2.4.4). The inspection/quality control area shall be provided with facilities that are suitable for examination and testing of the type of product being handled/processed. The inspection area shall: iii. Be kept clean to prevent product contamination.


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Site Location And Premises - Dust, Insect, And Pest Proofing

1. All external windows, ventilation openings, doors, and other openings shall be effectively sealed when closed and proofed against dust, vermin, and other pests. External personnel access doors shall be effectively insect-proofed and fitted with a self-closing device and proper seals to protect against entry of dust, vermin, and other pests.


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2. External doors, including overhead dock doors in food handling areas used for product, pedestrian, or truck access, shall be designed and maintained to prevent pest ingress by at least one or a combination of the following methods: i. A self-closing device;


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3. External doors, including overhead dock doors in food handling areas used for product, pedestrian, or truck access, shall be designed and maintained to prevent pest ingress by at least one or a combination of the following methods: ii. An effective air curtain;


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4. External doors, including overhead dock doors in food handling areas used for product, pedestrian, or truck access, shall be designed and maintained to prevent pest ingress by at least one or a combination of the following methods: iii. A pest-proof screen;


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5. External doors, including overhead dock doors in food handling areas used for product, pedestrian, or truck access, shall be designed and maintained to prevent pest ingress by at least one or a combination of the following methods: iv. A pest-proof annex; and


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6. External doors, including overhead dock doors in food handling areas used for product, pedestrian, or truck access, shall be designed and maintained to prevent pest ingress by at least one or a combination of the following methods: v. Adequate sealing around trucks in docking areas.


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7. Electric insect control devices, pheromone, or other traps and baits shall be located and operated so they do not present a contamination risk to the product, packaging, containers, or processing equipment. Poison rodenticide bait shall not be used inside ingredients or product storage areas or processing areas where ingredients, packaging, and products are handled, processed, or exposed.


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Site Location And Premises - Ventilation

1. Adequate ventilation shall be provided in enclosed processing and food handling areas. Where appropriate, positive air-pressure systems shall be installed to prevent airborne contamination.


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2. All ventilation equipment and devices in product storage and handling areas shall be adequately cleaned as per 9.2.5 to prevent unsanitary conditions.


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3. Extractor fans and canopies shall be provided in areas where open cooking operations are carried out or a large amount of steam is generated. Capture velocities shall be sufficient to prevent condensation build-up and to evacuate all heat, fumes, and other aerosols to the exterior via an exhaust hood positioned over the cooker(s).


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4. Fans and exhaust vents shall be insect-proofed and located so they do not pose a contamination risk and be kept clean.


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Site Location And Premises - Equipment And Utensils

1. Specifications for equipment and utensils and procedures for purchasing equipment shall be documented and implemented.


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2. Equipment and utensils shall be designed, constructed, installed, operated, and maintained to meet any applicable regulatory requirements and so as not to pose a contamination threat to products.


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3. Equipment storage rooms shall be designed and constructed to allow for the hygienic and efficient storage of equipment and containers. Where possible, food contact equipment shall be segregated from non-food contact equipment.


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4. Product contact surfaces and those surfaces not in direct contact with food in food handling areas, raw material storage, packaging material storage, and cold storage areas shall be constructed of materials that will not contribute a food safety risk.


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5. Benches, tables, conveyors, mixers, mincers, graders, and other mechanical processing equipment shall be hygienically designed and located for appropriate cleaning. Equipment surfaces shall be smooth, impervious, and free from cracks or crevices.


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6. Product containers, tubs, and bins used for edible and inedible material shall be constructed of materials that are non-toxic, smooth, impervious, and readily cleaned (refer to 9.2.5.1). Bins used for inedible material shall be clearly identified.


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7. All equipment and utensils shall be cleaned after use (refer to 9.2.5.1) or at a set and validated frequency to control contamination and be stored in a clean and serviceable condition to prevent microbiological or cross-contact allergen contamination.


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8. Vehicles used in food contact, handling, or processing zones or cold storage rooms shall be designed and operated so as not to present a food safety hazard.


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9. Non-conforming equipment shall be identified, tagged, and/or segregated for repair or disposal in a manner that minimizes the risk of inadvertent use, improper use, or risk to the integrity of finished product. Records of the handling, corrective action, and/or disposal of non-conforming equipment shall be maintained.


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Site Location And Premises - Grounds And Roadways

1. A suitable external environment shall be established, and the effectiveness of the measures shall be monitored and periodically reviewed. The premises, its surrounding areas, storage facilities, machinery, and equipment shall be kept free of waste or accumulated debris, and vegetation shall be controlled so as not to attract pests and vermin or present a food safety hazard to the sanitary operation of the site.


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2. Paths, roadways, and loading and unloading areas shall be maintained so as not to present a hazard to the food safety operations of the premises. They shall be adequately drained to prevent the pooling of water. Drains shall be separate from the site drainage system and regularly cleared of debris.


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3. Paths from amenities leading to site entrances shall be effectively sealed.


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Site Operation - Repairs And Maintenance

1. The methods and responsibility for the maintenance and repair of plant, equipment, and buildings shall be documented, planned, and implemented in a manner that minimizes the risk of product, packaging, or equipment contamination.


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2. Routine maintenance of plant and equipment in any food processing, handling, or storage areas shall be performed according to a maintenance control schedule and recorded. The maintenance schedule shall be prepared to include buildings, equipment, and other areas of the premises critical to the maintenance of product safety.


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3. Failures of plant and equipment in any food processing, handling, or storage areas shall be documented and reviewed, and their repair(s) incorporated into the maintenance control schedule.


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4. Site supervisors shall be notified when maintenance or repairs are to be undertaken in any processing, handling, or storage areas.


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5. The maintenance supervisor and the site supervisor shall be informed if any repairs or maintenance activities pose a potential threat to product safety (e.g., pieces of electrical wire, damaged light fittings, and loose overhead fittings). When possible, maintenance is to be conducted outside operating times.


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6. Temporary repairs, where required, shall not pose a food safety risk and shall be included in routine inspections (refer to 2.5.4.3) and the cleaning program. There shall be a plan in place to address the completion of temporary repairs to ensure they do not become permanent solutions.


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7. Food contact equipment and equipment located over food contact equipment shall be lubricated with food-grade lubricant, and its use shall be controlled to minimize the contamination of the product.


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8. Paint used in a food handling or processing area shall be suitable for use, in good condition, and not be used on any product contact surfaces.


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Site Operation - Maintenance Staff And Contractors

1. Maintenance staff and contractors shall comply with the site’s personnel and process hygiene requirements (refer to 9.3).


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2. All maintenance and other engineering contractors required to work on-site shall be trained in the site’s food safety and hygiene procedures or shall be escorted at all times until their work is completed.


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3. Maintenance staff and contractors shall remove all tools and debris from any maintenance activity, once it has been completed, and inform the area supervisor and maintenance supervisor, so appropriate hygiene and sanitation can be conducted and a pre-operational inspection completed prior to restarting site operations.


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Site Operation - Calibration

1. The methods and responsibility for calibration and re-calibration of measuring, test, and inspection equipment used for monitoring activities outlined in prerequisite programs, food safety plans, and other process controls, or to demonstrate compliance with customer specifications, shall be documented and implemented. Software used for such activities shall be validated as appropriate.


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2. Equipment shall be calibrated against national or international reference standards and methods or to an accuracy appropriate to its use. In cases where standards are not available, the site shall provide evidence to support the calibration reference method applied.


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3. Calibration shall be performed according to regulatory requirements and/or to the equipment manufacturers’ recommended schedule.


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4. Procedures shall be documented and implemented to address the resolution of potentially affected products, when measuring, test, or inspection equipment is found to be out of calibration.


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5. Calibrated measuring, testing, and inspection equipment shall be protected from damage and unauthorized adjustment or use.


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6. A directory of measuring, test, and inspection equipment that requires calibration and records of the calibration tests shall be maintained.


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Site Operation - Pest Prevention

1. A documented pest prevention program shall be effectively implemented. It shall: i. Describe the methods and responsibility for the development, implementation, and maintenance of the pest prevention program;


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2. A documented pest prevention program shall be effectively implemented. It shall: ii. Record pest sightings and trend the frequency of pest activity to target pesticide applications;


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3. A documented pest prevention program shall be effectively implemented. It shall: iii. Outline the methods used to prevent pest problems;


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4. A documented pest prevention program shall be effectively implemented. It shall: iv. Outline the pest elimination methods and the appropriate documentation for each inspection;


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5. A documented pest prevention program shall be effectively implemented. It shall: v. Outline the frequency with which pest status is to be checked;


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6. A documented pest prevention program shall be effectively implemented. It shall: vi. Include the identification, location, number, and type of applied pest control/monitoring devices on a site map;


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7. A documented pest prevention program shall be effectively implemented. It shall: vii. List the chemicals used. The chemicals are required to be approved by the relevant authority and their Safety Data Sheets (SDS) made available;


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8. A documented pest prevention program shall be effectively implemented. It shall: viii. Outline the methods used to make staff aware of the bait control program and the measures to take when they come into contact with a bait station;


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9. A documented pest prevention program shall be effectively implemented. It shall: ix. Outline the requirements for staff awareness and training in the use of pest and vermin control chemicals and baits; and


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10. A documented pest prevention program shall be effectively implemented. It shall: x. Measure the effectiveness of the program to verify the elimination of applicable pests and to identify trends.


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11. Pest contractors and/or internal pest controllers shall: i. Be licensed and approved by the local relevant authority;


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12. Pest contractors and/or internal pest controllers shall: ii. Use only trained and qualified operators who comply with regulatory requirements;


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13. Pest contractors and/or internal pest controllers shall: iii. Use only approved chemicals;


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14. Pest contractors and/or internal pest controllers shall: iv. Provide a pest prevention plan (refer to 2.3.2.8), which includes a site map, indicating the location of bait stations traps and other applicable pest control/monitoring devices;


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15. Pest contractors and/or internal pest controllers shall: v. Report to a responsible authorized person on entering the premises and after the completion of inspections or treatments;


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16. Pest contractors and/or internal pest controllers shall: vi. Provide regular inspections for pest activity with appropriate action taken if pests are present, and


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17. Pest contractors and/or internal pest controllers shall: vii. Provide a written report of their findings and the inspections and treatments applied.


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18. Pest activity risks shall be analyzed and recorded. Inspections for pest activity shall be conducted on a regular basis by trained site personnel and the appropriate action taken if pests are present. Identified pest activity shall not present a risk of contamination to food products, raw materials, or packaging. Records of all pest control inspections and applications shall be maintained.


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19. Food products, raw materials, or packaging that are found to be contaminated by pest activity shall be effectively disposed of, and the source of pest infestation shall be investigated and resolved. Records shall be kept of the disposal, investigation, and resolution.


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20. Pesticides shall be clearly labeled and stored (refer to 9.6.5) if kept on-site


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21. No animals shall be permitted on-site in food handling and storage areas.


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Site Operation - Cleaning And Sanitation

1. The methods and responsibility for the effective cleaning of the food handling and processing equipment and environment and storage areas shall be documented and implemented. Consideration shall be given to: i. What is to be cleaned;


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2. The methods and responsibility for the effective cleaning of the food handling and processing equipment and environment and storage areas shall be documented and implemented. Consideration shall be given to: ii. How it is to be cleaned;


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3. The methods and responsibility for the effective cleaning of the food handling and processing equipment and environment and storage areas shall be documented and implemented. Consideration shall be given to: iii. When it is to be cleaned;


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4. The methods and responsibility for the effective cleaning of the food handling and processing equipment and environment and storage areas shall be documented and implemented. Consideration shall be given to: iv. Who is responsible for the cleaning;


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5. The methods and responsibility for the effective cleaning of the food handling and processing equipment and environment and storage areas shall be documented and implemented. Consideration shall be given to: v. Validation of the cleaning procedures for food contact surfaces (including CIP);


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6. The methods and responsibility for the effective cleaning of the food handling and processing equipment and environment and storage areas shall be documented and implemented. Consideration shall be given to: vi. Methods used to confirm the correct concentrations of detergents and sanitizers; and


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7. The methods and responsibility for the effective cleaning of the food handling and processing equipment and environment and storage areas shall be documented and implemented. Consideration shall be given to: vii. The responsibility and methods used to verify the effectiveness of the cleaning and sanitation program.


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8. Detergents and sanitizers shall be suitable for use in a food manufacturing environment, labeled according to regulatory requirements and purchased in accordance with applicable legislation. The organization shall ensure that detergents and sanitizers are stored as outlined in element 9.6.5 and are handled only by trained staff.


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9. Detergents and sanitizers that have been mixed for use shall be correctly mixed according to the manufacturers’ instructions, stored in containers that are suitable for use, and clearly identified. Mix concentrations shall be verified and records maintained.


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10. Cleaning-in-place (CIP) systems, where used, shall not pose a chemical contamination risk to raw materials, ingredients, or product. CIP parameters critical to assuring effective cleaning shall be defined, monitored, and recorded (e.g., chemical and concentration used, contact time, and temperature). CIP equipment, including spray balls, shall be maintained, and any modifications to CIP equipment shall be validated. Personnel engaged in CIP activities shall be effectively trained.


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11. Cleaning equipment, tools, racks, and other items used in support of the cleaning and sanitizing program shall be clearly identified, stored, and maintained in a manner that prevents contamination of processing areas, product handling equipment, and storage areas as well as the tools themselves.


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12. Suitably equipped areas shall be designated for cleaning product containers, knives, cutting boards, and other utensils used by staff. The areas for these cleaning operations shall be controlled so they do not interfere with manufacturing operations, equipment, or product. Racks and containers for storing cleaned utensils shall be provided as required.


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13. Pre-operational inspections shall be conducted following cleaning and sanitation operations to ensure food processing areas, product contact surfaces, equipment, staff amenities, sanitary facilities, and other essential areas are clean before the start of production. Pre-operational inspections shall be conducted by qualified personnel.


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14. Staff amenities, sanitary facilities, and other essential areas shall be inspected by qualified personnel at a defined frequency to ensure the areas are clean.


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15. The responsibility and methods used to verify the effectiveness of the cleaning procedures shall be documented and implemented. A verification schedule shall be prepared. A record of pre-operational hygiene inspections, cleaning and sanitation activities, and verification activities shall be maintained.


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Personnel Hygiene And Welfare - Personnel Welfare

1. Personnel who are known to be carriers of infectious diseases that present a health risk to others through the packing or storage processes shall not engage in the processing or packing of food or enter storage areas where food is exposed.


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2. The site shall have measures in place to prevent contact of materials, ingredients, food packaging, food, or food contact surfaces from any bodily fluids, open wounds, coughing, sneezing, spitting, or any other means. In the event of an injury that causes the spillage of bodily fluid, a properly trained staff member shall ensure that all affected areas, including handling and processing areas, have been adequately cleaned and that all materials and products have been quarantined and/or disposed of.


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3. Personnel with exposed cuts, sores, or lesions shall not engage in handling or processing exposed products or handling primary (food contact) packaging or touching food contact surfaces. Minor cuts or abrasions on exposed parts of the body shall be covered with a colored, metal-detectable bandage or an alternative suitable waterproof and colored dressing.


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Personnel Hygiene And Welfare - Handwashing

1. All personnel shall have clean hands, and hands shall be washed by all staff, contractors, and visitors: i. On entering food handling or processing areas;


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2. All personnel shall have clean hands, and hands shall be washed by all staff, contractors, and visitors: ii. After each visit to a toilet;


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3. All personnel shall have clean hands, and hands shall be washed by all staff, contractors, and visitors: iii. After using a handkerchief;


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4. All personnel shall have clean hands, and hands shall be washed by all staff, contractors, and visitors: iv. After smoking, eating, or drinking; and


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5. All personnel shall have clean hands, and hands shall be washed by all staff, contractors, and visitors: v. After handling wash down hoses, cleaning materials, dropped product, or contaminated material.


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6. Handwashing stations shall be provided adjacent to all personnel access points and in accessible locations throughout food handling and processing areas as required.


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7. Handwashing stations shall be constructed of stainless steel or similar non-corrosive material and as a minimum supplied with: i. A potable water supply at an appropriate temperature;