2.1.1.1 Senior site management shall prepare and implement a policy statement that outlines the site’s commitment to quality and includes at a minimum: 2.1.1.2 The policy statement shall be displayed in a prominent position and communicated to all staff. It may be included in or separate from the organization’s food safety policy.
2.1.1.3 Senior site management shall implement, maintain, and continuously improve the quality culture within the site that ensures at a minimum: 2.1.1.4 Senior site management shall ensure the personnel performing key process steps and responsible for achieving quality objectives and meeting customer, regulatory, and company quality requirements are identified in the reporting structure and have the required competencies to carry out these functions.
2.1.1.5 Job descriptions for personnel performing key process steps and responsible for achieving quality requirements shall be documented and include provisions for coverage in the absence of key personnel.
2.1.1.6 Senior site management shall designate an SQF quality practitioner for each site with responsibility and authority to: 2.1.1.7 The SQF quality practitioner shall: 2.1.1.8 Senior site management shall develop and implement a quality communication program to ensure all staff: 2.1.1.9 Senior site management shall establish a process to trend progress in quality performance against agreed measures. Benchmarking shall be part of this process, and the performance data shall be reported at least annually, and communicated to all staff, to demonstrate effectiveness of the quality management system.
2.1.1.10 Sites that are certified to the SQF Quality Code may use the SQF Quality Shield. The use of the quality shield shall follow the requirements outlined in Appendix 4: SQF Quality Shield Rules of Use.
2.1.2.1 Senior site management shall be responsible for reviewing the performance of the SQF Quality System. Reviews shall include actions required to: 2.1.2.2 The SQF quality practitioner(s) shall update senior site management monthly at a minimum on matters impacting the implementation and maintenance of the SQF Quality System. The updates and management responses shall be documented. The SQF Quality System in its entirety shall be reviewed at least annually.
2.1.2.3 The quality system, including food quality plans, shall be reviewed when any changes are implemented that have an impact on the site’s ability to meet customer requirements and/or corporate quality requirements where applicable.
2.1.2.4 Senior site management shall ensure the integrity and continued operation of the quality system in the event of organizational or personnel changes within the company or associated facilities.
2.1.2.5 Senior site management shall document and implement a change management process that details how changes in specifications, materials, equipment, or resources are evaluated for their impact on quality, communicated to customers, and effectively implemented.
2.1.2.6 Records of all quality system reviews, reasons for amending documents, and changes to the SQF Quality System shall be maintained. Records shall include decisions for actions related to the improvement of the quality system and process effectiveness.
2.1.3.1 The methods and responsibilities for the complaint management process shall be documented and implemented. They shall include: 2.1.3.2 Trends from quality complaints shall be included in the performance measures established for the quality system.
2.1.3.3 Corrective and preventative action shall be implemented based on the seriousness of the incident and identified trends and shall be completed as outlined in 2.5.3.
2.1.3.4 Records of quality complaints, their investigation and resolution, if applicable, shall be maintained.
2.2.1.1 Electronic and/or hard copy documentation that outlines the methods and procedures the site shall use to meet the requirements of the SQF Quality Code shall be current and maintained. It shall be made available to staff and include: 2.2.2.1 The methods and responsibility for maintenance, storage, and distribution of quality documents shall be documented and implemented.
2.2.2.2 A register of current SQF Quality System documents and amendments to documents shall be maintained. Documents shall be safely stored and readily accessible.
2.2.3.1 The methods, frequency, and responsibility for verifying, maintaining, and retaining records shall be documented and implemented.
2.2.3.2 All records shall be legible and confirmed by those undertaking monitoring activities that demonstrate inspections, analyses, and other essential activities have been completed.
2.2.3.3 Records shall be readily accessible, retrievable, and securely stored to prevent unauthorized access, loss, damage, and deterioration. Records shall be retained in accordance with periods specified by customers or regulations or, at a minimum, no less than the product shelf- life.
2.3.1.1 The methods for designing, developing, and converting product concepts to commercial realization shall include a comparison of process controls with specification limits (i.e., process capability analysis) to ensure that processes can consistently supply products that meet customer specifications.
2.3.1.2 Product formulation, manufacturing processes, and the fulfillment of product quality requirements shall be validated by facility trials and product testing.
2.3.1.3 Shelf life trials shall be conducted for new products, or when there are changes in materials, ingredients, or equipment, to establish and validate a product’s packaging, handling, storage, and customer-use requirements through the end of its commercial life and consumer use.
2.3.2.1 Specifications for all raw materials and packaging, including but not limited to ingredients, additives, agricultural inputs (where applicable), hazardous chemicals, and processing aids that impact finished product quality shall be documented and kept current.
2.3.2.2 Raw and packaging quality parameters shall be verified upon receipt to ensure they meet specifications.
2.3.2.3 Product labels that are designed or specified by customers shall be approved by those customers. Records shall be maintained of customer approvals.
2.3.2.4 The register of current raw material and packaging specifications shall include those raw material and packaging materials that impact product quality and customer labels.
2.3.2.5 Finished product specifications shall be documented, current, approved by the site and its customers when required, and accessible to relevant staff. The specifications shall include product quality attributes, service delivery requirements, and labeling and packaging requirements.
2.3.2.6 Customer product specifications and delivery requirements shall be communicated to appropriate departments and staff within the site.
2.3.2.7 Specifications for contract services that have an impact on in-process or finished product quality shall be documented, current, include a full description of the service to be provided, and detail relevant training requirements of contract personnel. The register of contract service specifications shall list those services impacting product quality
2.3.3.1 The methods and responsibility for ensuring all agreements with contract manufacturers relating to quality, site/customer product requirements, their realization, and delivery shall be specified, documented, agreed upon, and implemented.
2.3.3.3 Records of audits, contracts, and changes to contractual agreements and their approvals shall be maintained.
2.3.4.1 Raw materials, ingredients, packaging materials, processing aids, and services, including co-manufactured products, that impact finished product quality shall be supplied by an approved supplier.
2.3.4.2 Material suppliers shall be selected and approved based on their ability to supply materials that meet quality specifications. The evaluation program shall require suppliers to: 2.3.4.3 Materials supplied shall only be accepted by the site based on either a certificate of analysis for each lot received, or inspection of the lot at receipt, to ensure materials comply with specifications. All receipts shall be visually inspected for damage and product integrity.
2.3.4.4 The approved supplier program shall include an agreement with suppliers for the return or disposal of materials that fail to meet specifications or are damaged or contaminated.
2.3.4.5 Any supplier audits performed shall be conducted by individuals knowledgeable of applicable regulatory and food quality requirements and trained in auditing techniques.
2.4.1.1 The methods and responsibilities for managing customer requirements and/or consumer expectations shall be documented and implemented. They shall include at a minimum: 2.4.1.2 Where customer products, materials, or equipment are used within the facility, the site shall have measures in place to safeguard customer property and ensure its correct and proper use.
2.4.2.1 The buildings and equipment shall be constructed, designed, and maintained to facilitate the manufacture, handling, storage, and/or delivery of food that meets customer specifications, regulatory requirements, and/or company quality requirements.
2.4.2.2 The methods and responsibility for the calibration of measuring, test, and inspection equipment used for quality testing of raw materials, work-in-progress, and finished product, for food quality 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.
2.4.2.3 Storage and transport of raw materials, work-in-progress, and finished product shall be suitable to maintain the integrity of the product without loss, waste, or damage and to meet customer requirements for inventory management and transportation, where applicable.
2.4.3.1 A food quality plan shall be developed, effectively implemented, and maintained in accordance with a risk-based method such as HACCP. The food quality plan may be combined with or independent from the food safety plan, but either way it must identify quality threats and critical quality points and their controls.
2.4.3.2 The food quality plan shall outline how the site controls and assures the quality attributes of the products or product groups and their associated processes.
2.4.3.3 The food quality plan shall be developed and maintained by a multidisciplinary team that includes the SQF quality practitioner and those site personnel with technical, production, and marketing knowledge of the relevant products and associated processes. Where the relevant expertise is not available on-site, advice may be obtained from other sources to assist the food quality team. The composition of the food quality team may be different from the food safety team.
2.4.3.4 The scope of the food quality plan shall be developed and documented, including the start and endpoints of the processes under consideration and all relevant inputs and outputs.
2.4.3.5 Product descriptions shall be developed and documented for all products included in the scope of the food quality plan. This shall include information in the finished product specifications (refer to 2.3.2.1) plus any additional quality or service attributes established by agreement with the customers.
2.4.3.6 The intended use of each product shall be determined and documented. This shall include, as appropriate, target consumer groups, ease of use by consumers, consumer instructions, evidence of tampering , and other applicable information affecting product quality.
2.4.3.7 The food quality team shall review the flow diagrams developed as part of the food safety plan and confirm and ensure process steps, process delays, and inputs and outputs that impact product quality are included.
2.4.3.8 The food quality team shall identify and document all quality threats that can reasonably be expected to occur at each step in the processes, including raw materials and other inputs.
2.4.3.9 The food quality team shall conduct a quality threat analysis for every identified quality threat to identify which threats are significant, i.e., their elimination or reduction to an acceptable level is necessary to ensure or maintain product quality. The methodology for determining threat significance shall be documented and used consistently to assess all potential quality threats.
2.4.3.10 The food quality team shall determine and document the control measures that must be applied to all significant quality threats. More than one control measure may be required to control an identified threat, and more than one significant threat may be controlled by a specific control measure.
2.4.3.11 Based on the results of the threat analysis (refer to 2.4.3.9), the food quality team shall identify the steps in the processes where control must be applied to eliminate a significant threat or reduce it to an acceptable level. These steps shall be identified as Critical Quality Points or CQPs.
2.4.3.12 For each identified CQP, the food quality team shall identify and document the quality limits that separate acceptable from unacceptable product. The food quality team shall validate the critical quality limits to ensure the designated level of control of the identified quality threat (s), and that all critical quality limits and control measures individually or in combination effectively provide the level of control required.
2.4.3.13 The food quality team shall develop and document procedures to monitor CQPs to ensure they remain within the established limits (refer to 2.4.3.12). Monitoring procedures shall identify the personnel assigned to conduct testing, the sampling and test methods, and the test frequency.
2.4.3.14 The food quality team shall develop and document deviation procedures that identify the disposition of affected product when monitoring indicates a loss of control at a CQP. The procedures shall also prescribe actions to correct the process step to prevent recurrence of the quality failure.
2.4.3.15 The documented and approved food quality plan shall be fully implemented. The effective implementation shall be monitored by the food quality team, and a full review of the documented and implemented plans shall be conducted at least annually, or when changes to the process, equipment, specifications or inputs occur which may affect product quality.
2.4.3.16 Implemented food quality plans shall be verified as part of SQF Quality System verification (refer to 2.5).
2.4.4.1 Processing parameters or in-process measurements shall be established, validated, and verified at a determined frequency to meet all customer, regulatory, and/or company requirements.
2.4.4.2 On-site laboratories and inspection stations shall be equipped and resourced to enable testing of in-process and finished products to meet customer, regulatory, and/ or company requirements and meet quality objectives. 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 2.3.2.7).
2.4.4.3 Process control methods shall be used to effectively control and optimize production processes to improve process efficiency, product quality, and reduce waste. Control charts and/or other quality tools shall be used for control of key processes
2.4.4.4 A sensory evaluation program shall be in place to ensure alignment with agreed customer and/or company requirements. Sensory evaluation results shall be communicated with relevant staff and with customers where appropriate.
2.4.4.5 Records of all quality inspections and analyses and statistical analyses shall be maintained.
2.4.5.1 Non-conforming product shall include products that fail to meet in-process or product requirements for quality. Non-conforming product shall be suitably identified, segregated, and appropriately dispositioned with records maintained.
2.4.5.2 Non-conforming equipment shall include equipment that is not suitable for use and/ or is not capable of producing products that meet in-process or product requirements for quality. Non-conforming equipment shall be identified and segregated from production areas, if possible, with appropriate documentation maintained.
2.4.5.3 The site shall document and implement a procedure to accept returned product that does not meet finished product specifications. The procedure shall include identification, handling, and disposition of returned goods to prevent redistribution or contamination of other products.
2.4.6.1 Procedures shall be documented and implemented to ensure product quality or formulation is not compromised by the rework process. Material to be reworked shall be identified and traceable. Rework operations shall be overseen by qualified personnel.
2.4.7.1 The site shall document and implement a positive product release procedure to ensure that, at the time of delivery to its customer, the food supplied complies with all agreed customer, regulatory, and/or company requirements, including but not limited to product specifications, sensory attributes, packaging and package integrity, labeling, delivery, and service requirements.
2.4.7.2 Records of all product release or disposition shall be maintained
2.5.1.1 Validation activities shall include those necessary to authenticate critical quality limits, process controls, and other quality tests established to meet customer requirements.
2.5.1.2 Records of validation of quality criteria shall be maintained.
2.5.2.1 The verification schedule shall include activities designed to ensure the effectiveness of process controls and quality tests.
2.5.2.2 The methods, responsibility, and criteria for verifying the effectiveness of monitoring critical quality points and other process and quality controls shall be documented and implemented. The methods applied shall ensure that personnel with responsibility for verifying monitoring activities authorize each record.
2.5.2.3 Verification activities shall include a comparison between process control limits and specification limits to ensure alignment and appropriate process control corrections.
2.5.2.4 Records of the verification of quality activities shall be maintained.
2.5.3.1 Corrective and preventative action methods shall include the identification of the root cause(s) and the resolution of non-compliance of critical quality limits and deviations from quality requirements.
2.5.4.1 Internal audit plans and methods shall include assessments of food quality plans, process controls, quality tests, and other activities implemented to meet finished product specifications as well as customer and company requirements.
2.5.4.2 Staff conducting the quality internal audits shall be trained and competent in internal audit procedures and have knowledge and experience in quality processes and process control methods as they relate to the scope of certification. Where practical, staff conducting internal audits shall be independent of the function being audited.
2.6.1.1 Finished product shall be labeled to the agreed customer, regulatory, and/or company requirements.
2.6.1.2 Product changeover procedures shall include verification of quality attributes required to meet finished product specifications and customer requirements.
2.6.1.3 Finished product shall be traceable forward to the customer, such as the retailer, distributor, or manufacturer (one forward).
2.6.1.4 All raw materials, ingredients, and packaging materials used in manufacturing a finished product and processing aids associated with the product shall be identified with the finished product lot number and traceable back to the supplier (one back).
2.6.2.1 The site’s recall and withdrawal procedures shall apply to product recalled or withdrawn due to failure to meet customer specifications or corporate quality requirements. Records shall be maintained and meet customer, regulatory, and company requirements, as applicable.
2.6.3.1 The crisis management plan prepared by senior site management shall include the methods by which the site shall, in the event of a crisis, maintain continuity of supply that meets customer, regulatory, and/or company product and service quality requirements.
2.6.3.2 The site shall contact its customers in the event of a crisis that impacts its ability to supply quality product.
2.7.1.1 The food fraud vulnerability assessment shall include the site’s susceptibility to ingredient or product substitution, mislabeling, dilution, and counterfeiting that could adversely impact food quality. This assessment may address both food safety and quality.
2.7.1.2 A food fraud mitigation plan shall be developed and implemented that specifies the methods to be used for controlling identified food fraud vulnerability that could adversely impact food quality.
2.8.1.1 The methods and responsibility for the identification, label approval, and processing of food and other products requiring the preservation of their identity preserved status (e.g., Kosher, Halal, organic, GMO free, regional provenance, free from, free trade, etc.) shall be documented and implemented.
2.8.1.2 Identification shall include a statement of the product’s identity preserved status of all ingredients, including additives, preservatives, processing aids, and flavorings.
2.8.1.3 Raw material and ingredient specifications for identity preserved foods shall include requirements for their handling, transport, storage, and delivery prior to use.
2.8.1.4 Assurances concerning the raw material or ingredient’s identity preserved status shall be by agreement with the supplier of the material.
2.8.1.5 The process description shall allow for a product’s identity preserved status to be maintained during manufacturing.
2.8.1.6 The processing of identity preserved foods shall be conducted under controlled conditions such that: 2.8.1.7 The identity preserved status shall be declared in accordance with regulatory requirements.
2.8.1.8 Additional customer-specific requirements for identity preserved foods shall be included in the finished product specification, as described in 2.3.2.5, or the label register and implemented by the site.
2.9.1.1 Appropriate training shall be provided for personnel carrying out the tasks critical to the effective implementation of the SQF Quality System and the maintenance and improvement of quality requirements.
2.9.1.2 Instructions shall be available explaining how all tasks critical to meeting customer and company specifications and quality and process efficiency are to be performed.
2.9.2.1 The employee training program shall include the necessary competencies for specific duties and the training methods to be applied for those staff carrying out tasks associated with: 2.9.2.2 The employee training program shall include: 2.9.2.3 Training records shall be maintained and include: 