Title Page
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Conducted on
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Prepared by
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Location
SQF System Elements for Food Manufacturing
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Part 1 out of 1
2.1 Management Commitment
2.1.1 Management Responsibility (Mandatory)
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2.1.1.1 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; ii.Establish and maintain a food safety culture within the site; iii. Establish and continually improve the site's food safety management system; and iv. Comply with customer and regulatory requirements to supply safe food. The policy statement shall be: v. Signed by the senior site manager and displayed in prominent positions; and vi. Effectively communicated to all site personnel in the language(s) understood by all site personnel
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2.1.1.2 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; ii. Adequate resources are available to meet food safety objectives; iii. Food safety practices and all applicable requirements of the SQF System are adopted and maintained; iv. Employees are informed and held accountable for their food safety and regulatory responsibilities; v. Employees are positively encouraged and required to notify management about actual or potential food safety issues; and vi. Employees are empowered to act to resolve food safety issues within their scope of work
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2.1.1.3 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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2.1.1.4 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; ii. Take appropriate action to ensure the integrity of the SQF System; and iii. Communicate to relevant personnel all information essential to ensure the effective implementation and maintenance of the SQF System
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Need to identify a backup practioner
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2.1.1.5 The primary and substitute SQF practitioner shall: i. Be employed by the site; ii. Hold a position of responsibility related to the management of the site's SQF System; iii. Have completed a HACCP training course; iv. Be competent to implement and maintain HACCP based food safety plans; and v. Have an understanding of the SQF Food Safety Code: Food Manufacturing and the requirements to implement and maintain an SQF System relevant to the site's scope of certification
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2.1.1.6 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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2.1.1.7 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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2.1.1.8 Senior site management shall designate defined blackout periods that prevent unannounced recertification 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 recertification window for the agreed upon unannounced audit
2.1.2 Management Review (Mandatory)
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2.1.2.1 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); ii. Food safety culture performance; iii. Food safety objectives and performance measures; iv. Corrective and preventative actions and trends in findings from internal and external audits, customer complaints, and verification and validation activities; v. Hazard and risk management system; and vi. Followup action items from previous management reviews. Records of all management reviews and updates shall be maintained
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2.1.2.2 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
2.1.3 Complaint Management (Mandatory)
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2.1.3.1 The methods and responsibility for handling, investigating, and resolving food safety complaints from commercial customers, consumers, and authorities, arising from products manufactured or handled onsite or co-manufactured, shall be documented and implemented
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2.1.3.2 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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2.1.3.3 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
2.2 Document Control and Records
2.2.1 Food Safety Management System (Mandatory)
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2.2.1.1 The methods and procedures the site uses to meet the requirements of the SQF Food Safety Code: Food 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; ii. The food safety policy statement and organization chart; iii. The processes and products included in the scope of certification; iv. Food safety regulations that apply to the manufacturing site and the country(ies) of sale (if known); v. Raw material, ingredient, packaging, and finished product specifications; vi. Food safety procedures, prerequisite programs, food safety plans; vii. Process controls that impact product safety; and viii. Other documentation necessary to support the development, implementation, maintenance, and control of the SQF System
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2.2.1.2 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
2.2.2 Document Control (Mandatory)
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2.2.2.1 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
2.2.3 Records (Mandatory)
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2.2.3.1 The methods, frequency, and responsibility for verifying, maintaining, and retaining records shall be documented and implemented
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2.2.3.2 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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2.2.3.3 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 shelflife or established by the site if no shelflife exists
2.3 Specification, Formulations, Realization, and Supplier Approval
2.3.1 Product Formulation and Realization
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2.3.1.1 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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2.3.1.2 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.<br><br>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:<br>i. Pre-consumer handling and storage requirements, including the establishment of “use by,” “best before dates,” or equivalent terminology;<br>ii. Microbiological criteria, where applicable; and<br>iii. Consumer preparation, where applicable, and storage and handling requirements.<br>
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2.3.1.3 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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2.3.1.4 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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2.3.1.5 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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2.3.1.6 Records of product design, formulations, label compliance, process flows, shelf life trials, and approvals for all new and existing products shall be maintained
2.3.2 Specifications (Raw Material, Packaging, Finished Product and Services)
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2.3.2.1 The methods and responsibility for developing, managing, and approving raw material, finished product, and packaging specifications shall be documented
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2.3.2.2 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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2.3.2.3 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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2.3.2.4 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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2.3.2.5 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 vary by crop or by season)
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2.3.2.6 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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2.3.2.7 Finished product labels shall be accurate, comply with the relevant legislation, and be approved by qualified company personnel
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2.3.2.8 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 of all contract personnel
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2.3.2.9 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; ii. Composition to meet label claims; iii. Labeling and packaging requirements; and iv. Storage conditions
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2.3.2.10 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
2.3.3 Contract Manufacturers
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2.3.3.1 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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2.3.3.2 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: Food Manufacturing and regulatory and customer requirements; ii. Products and processes of co-manufacturers that are considered low-risk meet the requirements of the SQF Food Safety Code: Food Manufacturing, or other GFSI benchmarked certification programs, and regulatory and customer requirements; and iii. Changes to contractual agreements are approved by both parties and communicated to relevant personnel
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2.3.3.3 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: Food 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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2.3.3.4 Records of audits, contracts, and changes to contractual agreements and their approvals shall be maintained
2.3.4 Approved Supplier Program (Mandatory)
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2.3.4.1 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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2.3.4.2 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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2.3.4.3 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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2.3.4.4 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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2.3.4.5 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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2.3.4.6 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
2.4 Food Safety System
2.4.1 Food Legislation (Mandatory)
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2.4.1.1 The site shall ensure that at the time of delivery to customers finished products shall 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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2.4.1.2 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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2.4.1.3 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
2.4.2 Good Manufacturing Practices (Mandatory)
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2.4.2.1 The site shall ensure the applicable Good Manufacturing Practices described in Module 11 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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2.4.2.2 The Good Manufacturing Practices applicable to the scope of certification outlining how food safety is controlled and assured shall be documented and implemented
2.4.3 Food Safety Plan (Mandatory)
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2.4.3.1 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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2.4.3.2 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, processing aids, products, and associated processes. Where the relevant expertise is not available onsite, advice may be obtained from other sources to assist the food safety team
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2.4.3.3 The scope of each food safety plan shall be developed and documented including the start and endpoints of the processes under consideration and all relevant inputs and outputs
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2.4.3.4 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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2.4.3.5 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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2.4.3.6 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, 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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2.4.3.7 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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2.4.3.8 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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2.4.3.9 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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2.4.3.10 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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2.4.3.11 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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2.4.3.12 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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2.4.3.13 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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2.4.3.14 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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2.4.3.15 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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2.4.3.16 Critical control point monitoring, corrective action, and verification records shall be maintained and appropriately used
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2.4.3.17 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
2.4.4 Product Sampling, Inspection and Analysis
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2.4.4.1 The methods, responsibility, and criteria for sampling, inspecting, and/or analyzing raw materials, working 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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2.4.4.2 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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2.4.4.3 Onsite 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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2.4.4.4 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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2.4.4.5 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 shelflife of the product
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2.4.4.6 Records of all inspections and analyses shall be maintained
2.4.5 Nonconforming Materials and Product
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2.4.5.1 The responsibility and methods outlining how to handle nonconforming product, raw material, ingredient, working progress, or packaging, which is detected during receipt, storage, processing, handling, or delivery, shall be documented and implemented. The methods applied shall ensure: i. Nonconforming 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 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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2.4.5.1 Quarantine records and records of the handling, corrective action, or disposal of nonconforming materials or product shall be maintained
2.4.6 Product Rework
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2.4.6.1 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; ii. Reworked product is clearly identified and traceable; iii. Reworked product is processed in accordance with the site’s food safety plan; iv. Each batch of reworked product is inspected or analyzed as required before release; v. Inspections and analyses conform to the requirements outlined in element 2.4.4.1; vi. Release of reworked product conforms to element 2.4.7; and vii. Reworked product does not affect the safety or integrity of the finished product. Records of all reworking operations shall be maintained
2.4.7 Product Release (Mandatory)
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2.4.7.1 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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2.4.7.2 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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2.4.7.3 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 offsite or contract warehouses are used, these requirements shall be effectively communicated and verified as being followed
2.4.8 Environmental Monitoring
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2.4.8.1 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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2.4.8.2 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; ii. List the number of samples to be taken and the frequency of sampling; iii. Outline the locations in which samples are to be taken and the rotation of locations as needed; and iv. Describe the methods to handle elevated or undesirable results
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2.4.8.3 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
