SQF Edition 9 (2.5 - 2.9)

• Conducted on

  Date

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  Address

SQF System Elements for Food Manufacturing

• Part 2 out of 2

2.5 SQF System Verification

2.5.1 Validation and Effectiveness (Mandatory)

• 2.5.1.1 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 validate that: i. Good Manufacturing Practices are confirmed to ensure they achieve the required results; ii. Critical food safety limits are reviewed annually and revalidated or justified by regulatory standards when changes occur; and iii. Changes to the processes or procedures are assessed to ensure the controls are still effective. Records of all validation activities shall be maintained

  Compliant

  Minor NC

  Major NC

  Critical NC

  N/A

2.5.2 Verification Activities (Mandatory)

• 2.5.2.1 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

  Compliant

  Minor NC

  Major NC

  Critical NC

  N/A

• 2.5.1.2 A verification 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

  Compliant

  Minor NC

  Major NC

  Critical NC

  N/A

2.5.3 Corrective and Preventative Action (Mandatory)

• 2.5.3.1 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 noncompliance 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, non-conformances raised at internal or external audits and inspections, nonconforming product and equipment, withdrawals and recalls, as appropriate

  Compliant

  Minor NC

  Major NC

  Critical NC

  N/A

• 2.5.3.1 Records of all investigation, root cause analysis, and resolution of nonconformities, their corrections, and the implementation of preventative actions shall be maintained

  Compliant

  Minor NC

  Major NC

  Critical NC

  N/A

2.5.4 Internal Audits and Inspections (Mandatory)

• 2.5.4.1 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: Food Manufacturing are audited per the SQF audit checklist or a similar tool; ii. Objective evidence is recorded to verify compliance and/or noncompliance; iii. Corrective and preventative actions of deficiencies identified during the internal audits are undertaken; and iv. Audit results are communicated to relevant management personnel and staff responsible for implementing and verifying corrective and preventative actions

  Compliant

  Minor NC

  Major NC

  Critical NC

  N/A

• 2.5.4.2 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

  Compliant

  Minor NC

  Major NC

  Critical NC

  N/A

• 2.5.4.3 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: Food Manufacturing. The site shall: i. Take corrections or corrective and preventative action; and ii. Maintain records of inspections and any corrective actions taken

  Compliant

  Minor NC

  Major NC

  Critical NC

  N/A

• 2.5.4.4 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)

  Compliant

  Minor NC

  Major NC

  Critical NC

  N/A

2.6 Product Traceability and Crisis Management

2.6.1 Product Identification (Mandatory)

• 2.6.1.1 The methods and responsibility for identifying raw materials, ingredients, packaging, working 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, working progress, process inputs, and finished products are clearly identified during all stages of receipt, production, storage, and dispatch; and ii. Finished product is labeled to the customer specification and/or regulatory requirements

  Compliant

  Minor NC

  Major NC

  Critical NC

  N/A

• 2.6.1.2 Product startup, 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

  Compliant

  Minor NC

  Major NC

  Critical NC

  N/A

2.6.2 Product Trace (Mandatory)

• 2.6.2.1 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; 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.); iii. Traceability is maintained where product is reworked (refer to 2.4.6); and 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

  Compliant

  Minor NC

  Major NC

  Critical NC

  N/A

2.6.3 Product Withdrawal and Recall (Mandatory)

• 2.6.3.1 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; ii. Describe the management procedures to be implemented, including sources of legal, regulatory, and expert advice, and essential traceability information; iii. Outline a communication plan to inform site personnel, customers, consumers, authorities, and other essential bodies in a timely manner appropriate about the nature of the incident; and iv. 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

  Compliant

  Minor NC

  Major NC

  Critical NC

  N/A

• 2.6.3.2 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

  Compliant

  Minor NC

  Major NC

  Critical NC

  N/A

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

  Compliant

  Minor NC

  Major NC

  Critical NC

  N/A

• 2.6.3.4 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

  Compliant

  Minor NC

  Major NC

  Critical NC

  N/A

2.6.4 Crisis Management Planning

• 2.6.4.1 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; ii. The nomination and training of a crisis management team; iii. The controls implemented to ensure any responses do not compromise product safety; iv. The measures to isolate and identify product affected by a response to a crisis; v. The measures taken to verify the acceptability of food prior to release; vi. The preparation and maintenance of a current crisis alert contact list, including supply chain customers; vii. Sources of legal and expert advice; and viii. The responsibility for internal communications and communicating with authorities, external organizations, and media

  Compliant

  Minor NC

  Major NC

  Critical NC

  N/A

• 2.6.4.2 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

  Compliant

  Minor NC

  Major NC

  Critical NC

  N/A

2.7 Food Defense and Food Fraud

2.7.1 Food Defense Plan (Mandatory)

• 2.7.1.1 A food defense threat assessment shall be conducted to identify potential threats that can be caused by a deliberate act of sabotage or terroristlike incident

  Compliant

  Minor NC

  Major NC

  Critical NC

  N/A

• 2.7.1.2 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; ii. The name of the senior site management person responsible for food defense; iii. The methods implemented to ensure only authorized personnel have access to production equipment and vehicles, manufacturing, and storage areas through designated access points; iv. The methods implemented to protect sensitive processing points from intentional adulteration; 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; vi. The measures implemented to ensure raw materials, ingredients, packaging (including labels), working progress, process inputs, and finished products are held under secure storage and transportation conditions; and vii. The methods implemented to record and control access to the premises by site personnel, contractors, and visitors

  Compliant

  Minor NC

  Major NC

  Critical NC

  N/A

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

  Compliant

  Minor NC

  Major NC

  Critical NC

  N/A

• 2.7.1.4 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

  Compliant

  Minor NC

  Major NC

  Critical NC

  N/A

2.7.2 Food Fraud (Mandatory)

• 2.7.2.1 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

  Compliant

  Minor NC

  Major NC

  Critical NC

  N/A

• 2.7.2.2 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

  Compliant

  Minor NC

  Major NC

  Critical NC

  N/A

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

  Compliant

  Minor NC

  Major NC

  Critical NC

  N/A

• 2.7.2.4 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

  Compliant

  Minor NC

  Major NC

  Critical NC

  N/A

2.8 Allergen Management

2.8.1 Allergen Management (Mandatory)

• 2.8.1.1 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; ii. An assessment of workplace-related food allergens that may originate from locker rooms, vending machines, lunchrooms, and visitors; iii. A list of allergens that is applicable in the country of manufacture and the country(ies) of destination, if known; iv. A list of allergens that is accessible to relevant staff; v. The control of hazards associated with allergens and incorporated into the food safety plan, and vi. Management plans for control of the identified allergens

  Compliant

  Minor NC

  Major NC

  Critical NC

  N/A

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

  Compliant

  Minor NC

  Major NC

  Critical NC

  N/A

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

  Compliant

  Minor NC

  Major NC

  Critical NC

  N/A

• 2.8.1.4 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.<br>Separate handling and production equipment shall be provided, where satisfactory line hygiene and clean-up or segregation are not possible.

  Compliant

  Minor NC

  Major NC

  Critical NC

  N/A

• 2.8.1.5 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

  Compliant

  Minor NC

  Major NC

  Critical NC

  N/A

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

  Compliant

  Minor NC

  Major NC

  Critical NC

  N/A

• 2.8.1.7 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

  Compliant

  Minor NC

  Major NC

  Critical NC

  N/A

• 2.8.1.8 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

  Compliant

  Minor NC

  Major NC

  Critical NC

  N/A

• 2.8.1.9 The site shall document and implement methods to control the accuracy of finished product labels (or consumer information where applicable) and assure working 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 change over procedures

  Compliant

  Minor NC

  Major NC

  Critical NC

  N/A

• 2.8.1.10 Reworking of product (refer to 2.4.6) containing food allergens shall be conducted under conditions that ensure product safety and integrity are maintained. Reworked product containing allergens shall be clearly identified and traceable

  Compliant

  Minor NC

  Major NC

  Critical NC

  N/A

• 2.8.1.11 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

  Compliant

  Minor NC

  Major NC

  Critical NC

  N/A

2.9 Training

2.9.1 Training Requirements

• 2.9.1.1 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)

  Compliant

  Minor NC

  Major NC

  Critical NC

  N/A

• 2.9.1.2 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

  Compliant

  Minor NC

  Major NC

  Critical NC

  N/A

2.9.2 Training Program (Mandatory)

• 2.9.2.1 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; ii. Monitoring and corrective action procedures for all staff engaged in monitoring critical control points (CCPs); iii. Personal hygiene for all staff involved in the handling of food products and food contact surfaces; iv. Good Manufacturing Practices and work instructions for all staff engaged in food handling, food processing, and equipment; v. Sampling and test methods for all staff involved in sampling and testing of raw materials, packaging, working progress, and finished products; vi. Environmental monitoring for relevant staff; vii. Allergen management, food defense, and food fraud for all relevant staff; and 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

  Compliant

  Minor NC

  Major NC

  Critical NC

  N/A

• 2.9.2.2 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

  Compliant

  Minor NC

  Major NC

  Critical NC

  N/A

• 2.9.2.3 Training records shall be maintained and include: i. Participant name; ii. Skills description; iii. Description of the training provided; iv. Date training completed; v. Trainer or training provider; and vi. Verification that the trainee is competent to complete the required tasks

  Compliant

  Minor NC

  Major NC

  Critical NC

  N/A

• QA & Manufacturing Director

  Sign

• QA Manager

  Sign

• QA Supervisor

  Sign