SQFI Manufacturing of Food Packaging Checklist
2.1.1 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 sector packaging; 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 sector packaging. The policy statement shall be: v. Signed by the senior site manager and displayed in prominent positions; and vi. vi. Effectively communicated to all site personnel in language(s) understood by all site personnel.
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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. Staff are informed and held accountable for their food safety and regulatory responsibilities; v. Staff are positively encouraged and required to notify management of actual or potential food safety issues; and vi. Staff are empowered to act to resolve food safety issues within their scope of work.
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3. The reporting structure shall identify and describe site personnel with specific responsibilities for tasks within the food safety management system and identify backup for 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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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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5. The primary and substitute SQF practitioner shall: i. Be employed by the site; ii. Hold a position of responsibility in relation 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: Manufacture of Food Packaging and the requirements to implement and maintain an SQF System relevant to the site’s scope of certification.
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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 sector packaging.
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8. Senior site management shall inform their certification body of any defined blackout periods that prevent unannounced re-certification audits from occurring 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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2.1.2 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); 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. Follow-up action items from previous management review. Records of all management reviews and updates shall be maintained.
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2.1.3 Complaint Management (Mandatory)
3.8.1 Waste Disposal
1. The responsibility and methods used to collect, handle, and store waste prior to removal from the premises shall be documented and implemented. This shall include consideration of the path of waste removal to prevent cross contamination in food sector packaging manufacturing, handling, and storage areas. Disposal of hazardous chemicals and toxic substances shall comply with 13.6.2.5.
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3. Waste disposal equipment, trolleys, vehicles, and collection bins shall be maintained in a serviceable condition and cleaned regularly so as not to attract pests and other vermin. Designated waste accumulation and storage areas shall be well-maintained while awaiting external collection.
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2.2.1 Food Safety Management System (Mandatory)
1. The methods and procedures the site uses to meet the requirements of the SQF Food Safety Code: Manufacture of Food Packaging shall be maintained in electronic and/or hard copy documentation. It 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 to the country of sale (if known); v. Raw material, ingredient, packaging, and finished product specifications; vi. Food safety procedures, pre-requisite programs, and food safety plans; vii. Process controls that impact product safety; and viii. Other documentation necessary to support the development and the implementation, maintenance, and control of the SQF System.
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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.
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2.2.2 Document Control (Mandatory)
2.2.3 Records (Mandatory)
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 a minimum the product shelf life, or established by the site if no shelf life exists.
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2.3.1 Product Formulation And Realization
2.3.2 Specifications (Raw Material, Packaging, Finished Product And Services)
3. Finished product labels shall be accurate, comply with the relevant legislation, and be approved by qualified company personnel. Printed materials applied to or printed directly on finished product shall be accurate, legible, and comply with customer and regulatory requirements, including information regarding ingredients, allergens, identification codes, and other requirements. They shall be approved by designated company personnel and controlled to ensure relevance and accuracy.
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4. All raw materials including those made with recycled material, plant-based material, or additional additives shall be suitable for the intended use, food contact compliant where applicable, and shall comply with the relevant legislation in the country of manufacture and country of destination, if known.
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6. Raw and auxiliary packaging materials shall be verified to ensure food safety is not compromised and the material is fit for its intended purpose. Verification of raw and packaging materials’ conformance to food safety specifications shall include a letter of guarantee and a certificate of conformance, certificate of analysis, inspection, sampling, or testing.
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8. Finished product specifications shall be documented, current, approved by the site and their customer, if applicable, accessible to relevant staff, and may include: i. Physical and chemical characteristics; ii. Microbiological characteristics, where applicable; iii. Artwork and unitizing requirements; iv. Confirmation that the food sector packaging is suitable for the intended use by the customer; and v. Lists of raw materials, allergens, ingredients, identification codes, etc. Specifications for direct food contact packaging shall list the functional characteristics to protect the food product (shelf life extension, barrier properties, etc.).
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9. Specifications for raw materials, auxiliary packaging materials, processing aids, printed materials, finished products, and contract services 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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2.3.3 Contract Manufacturers
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: i. Verify compliance with the SQF Food Safety Code: Manufacture of Food Packaging and that all customer requirements are being met at all times. ii. Ensure changes to contractual agreements are approved by both parties and communicated to relevant personnel.
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2.3.4 Approved Supplier Program (Mandatory)
2. The approved supplier program shall be based on the prior performance of a supplier and the risk level of the raw and packaging materials and services supplied. The program shall contain at a minimum: i. Agreed specifications (refer to 2.3.2); ii. Reference to the risk rating of the supplier, materials, or services supplied; iii. An assessment of the supplier’s food safety risks and or controls to ensure that supplied materials does not pose a risk to food safety; iv. Methods for granting approved supplier status; v. Methods and frequency of monitoring approved suppliers; vi. Details of the certificates of analysis or conformance if required; and vii. Methods and frequency of reviewing approved supplier performance and status.
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4. Raw materials and services that impact finished product food safety shall meet the agreed specification (refer to 2.3.2.2) and be supplied by an approved supplier. The receipt of raw materials, processing aids, and packaging from non-approved 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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2.4.1 Food Legislation (Mandatory)
1. The site shall ensure that, at the time of delivery to customers, finished products shall comply with food safety legislation applicable to the country of manufacture and sale. This includes compliance with legislative requirements applicable to food safety, packaging, product descriptions, any other criteria listed under food legislation, and to relevant established industry codes of practice.
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2.4.2 Good Manufacturing Practices (Mandatory)
1. The site shall ensure the applicable Good Manufacturing Practices described in Module 13 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 to ensure that food safety is not compromised.
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2.4.3 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, maintained, and outline the means by which 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 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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4. Product descriptions shall be developed and documented for all food sector packaging included in the scope of the food safety plans. This shall reference the finished product specifications (refer to 2.3.2.8) plus any additional information relevant to product safety such as water vapor transmission rate and gas permeability and the intended and potential alternative uses of each. This shall include requirements for further processing, if applicable.
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5. 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 material, packaging material, service inputs (e.g., water, steam, gasses as appropriate), 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 conduct a hazard analysis for every identified hazard to identify which hazards are significant, i.e., their elimination or reduction to an acceptable level is necessary to ensure food safety. The methodology for determining hazard significance shall be documented and used consistently to assess all potential hazards.
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8. 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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9. Based on the results of the hazard analysis (refer to 2.4.3.7), 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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10. 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 the critical limits to ensure the designated 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 2.5.1.1).
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11. 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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12. The food safety team shall develop and document deviation procedures that identify the disposition of affected food sector packaging material 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 food safety failure.
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13. 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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16. 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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2.4.4 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 specification 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, 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 analysis, 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 equivalent international standard and included on the site’s contract service specifications list (refer to 2.3.2.7).
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3. On-site laboratories conducting chemical and microbiological analysis that may pose a risk to product safety, shall be located separate from any 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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2.4.5 Non-conforming Materials And Product
1. The responsibility and methods outlining how non-conforming raw material, work-in-progress, finished product, or equipment detected during receipt, storage, manufacturing, or delivery is handled shall be documented and implemented. The methods applied shall ensure: i. Non-conforming product is quarantined, identified, handled, and 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 staff is aware of the organization’s quarantine and release requirements applicable to equipment or product placed under quarantine status.
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2.4.6 Product Rework
1. The responsibility and methods outlining how raw materials or food sector packaging product are reworked and recouped shall be documented and implemented. Rework shall be processed in a manner that does not contaminate raw materials or food sector packaging. The methods applied shall ensure: i. Reworking and recouping operations are supervised by qualified personnel; ii. Reworked and recouped product is clearly identified and traceable; iii. Each lot of reworked or recouped product is inspected or analyzed as required before release; iv. Inspections and analyses shall conform to the requirements outlined in element 2.4.4.1; v. Release of reworked and recouped product shall conform to element 2.4.7; and vi. Records of all reworking operations shall be maintained.
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2.4.7 Product Release (Mandatory)
1. The responsibility and methods for releasing finished product shall be documented and implemented. Methods shall ensure product is released by designated personnel only after disposition activities show that product is acceptable for release and to verify legislative and food safety compliance have been met.
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2. 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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2.4.8 Environmental Monitoring
2.5.1 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 validate that: i. Good Manufacturing Practices are confirmed to ensure they achieve the required results; ii. Critical food safety limits are reviewed annually and re-validated 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.
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2.5.2 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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2.5.3 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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2.5.4 Internal Audits And Inspections (Mandatory)
1. An internal audit program shall be established to verify the implementation and effectiveness of all applicable requirements of the SQF Food Safety System. 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: Manufacture of Food Packaging are audited; ii. Corrective and preventative action of deficiencies identified during the internal audits are undertaken; and iii. Audit results are communicated to relevant management personnel and staff responsible for implementing and verifying corrective actions.
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3. Regular inspections of the site and equipment shall be planned and carried out to verify Good Manufacturing Practices and facilities and equipment maintenance is compliant to the SQF Food Safety Code: the Manufacturing of Food Packaging. The site shall: i. Take corrections or corrective and preventative action; and ii. Maintain records of inspections and any corrective action taken.
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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).
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2.6.1 Product Identification (Mandatory)
1. The methods and responsibility for identifying raw materials, packaging, and finished products during all stages of production and storage shall be documented and implemented. The identification system shall be implemented to ensure: i. Raw and packaging materials, work-in-progress, process inputs, recycled materials, 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, where applicable, and/or regulatory requirements.
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2. Product start-up and changeover procedures during manufacture of food sector packaging shall be documented and implemented to ensure that the correct product information is applied or labeled and that the changeover is inspected and approved by an authorized person. Product identification records shall be maintained.
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2.6.2 Product Trace (Mandatory)
1. The responsibility and methods used to trace product shall be documented and implemented to ensure: i. Finished product is traceable to the customer (minimum one step forward) and provides traceability through the process to the supplier and date of receipt of raw materials, auxiliary packaging, processing aids, and other inputs (minimum one step back); ii. Traceability is maintained where product is reworked (refer to 2.4.6); and iii. The effectiveness of the product trace system is tested and documented at least annually as part of the product recall and withdrawal review (refer to 2.6.3.1). Records of raw and auxiliary packaging material receipt and use and finished product dispatch and destination shall be maintained.
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2.6.3 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 coordinating, managing, and investigating a product withdrawal or recall with customers; ii. Describe the procedures to be implemented by site management, including sources of legal, regulatory, and expert advice; iii. Outline a communication plan to inform customers, consumers, authorities, and other essential bodies in a timely manner appropriate to the nature of the incident; and iv. Ensure that SQFI, the certification body, and the appropriate regulatory authority are listed as an essential body and notified in instances of a food safety incident of a public nature or product recall for any reason.
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2. The withdrawal and recall system shall be reviewed, tested, and verified as effective at least annually. Testing shall include incoming materials (minimum one step back) and finished product (minimum 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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2.6.4 Crisis Management Planning
1. A crisis management plan that is based on the understanding of known potential dangers (e.g. flood, drought, fire, tsunami, pandemic, or other severe weather or regional events such as warfare, civil unrest, or pandemic) that can impact the site’s ability to deliver safe food sector packaging 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 as 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 a response does 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 sector packaging 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.
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2.7.1 Food Defense Plan (Mandatory)
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 and packaging materials, equipment, and hazardous chemicals; vi. The measures implemented to ensure raw and packaging materials, labels, process inputs, work-in-progress, 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 employees, contractors, and visitors.
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2.7.2 Food Fraud (Mandatory)
1. The methods, responsibility, and criteria for identifying the site’s vulnerability to food fraud shall be implemented and maintained. A food fraud vulnerability assessment shall be conducted to identify the site’s susceptibility to substitution, mislabeling, and counterfeiting of raw materials and finished product that may adversely impact the food safety of the product.
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2.8.1 Allergen Management (Mandatory)
1. The responsibility and methods used to control allergens and to prevent sources of allergens from contaminating food sector packaging shall be documented and implemented. The allergen management program shall include: i. A detailed risk analysis and assessment of workplace-related food allergens, raw materials, printed packaging, and/or processing aids, including food grade lubricants, that may contain food allergens or food allergen statements; ii. A list of allergens that is applicable in the country of manufacture and the country(ies) of destination if known; iii. A list of allergens that is accessible by relevant staff; iv. The food safety hazards associated with allergens and their control incorporated into the food packaging safety plan; v. A management plan for control of identified allergens; vi. Cleaning and sanitation of product contact surfaces between line changeovers is effective, appropriate to the risk and legal requirements, and sufficient to remove all potential target allergens from product contact surfaces; and vii. Based on the risk assessment, procedures for validation and verification of the effectiveness of the cleaning and sanitation of areas and equipment in which allergens are used is effectively implemented.
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2.9.1 Training Requirements
1. The responsibility for establishing and implementing the training needs of the site’s personnel to ensure they have the required competencies to carry out functions affecting the manufacture of safe food sector packaging and regulatory compliance shall be defined and documented (refer to 2.1.1.6).
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2.9.2 Training Program (Mandatory)
1. A training program shall be documented and implemented that outlines at a minimum the necessary competencies for specific duties and the training methods to be applied for 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; iv. Good Manufacturing Practices and work instructions for all staff engaged in the handling, storage, and manufacturing of food sector packaging and equipment; v. Applying food safety regulatory requirements; vi. Sampling and test methods for all staff involved in sampling and testing of raw materials, packaging, work-in-progress, and finished products; vii. Environmental monitoring for relevant staff; viii. Allergen management, food defense, and food fraud for all relevant staff; and ix. Tasks identified as critical to meeting effective implementation and maintenance of the SQF Code. The training program shall include provision for identifying and implementing the refresher training needs of the site.
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3.1.1 Premises Location And Approval
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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3.1.3 Lightings And Light Fittings
2. Light fittings in food sector packaging manufacturing, handling, and storage areas 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 shall be protected from accidental breakage, manufactured from cleanable materials, and included in the cleaning and sanitation program.
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3.1.4 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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4. Electric insect control devices, pheromone, or other traps and baits shall be located so as not to present a contamination risk to food sector packaging or manufacturing equipment. Poison rodenticide bait shall not be used inside food sector packaging manufacturing, handling, or storage areas.
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3.1.5 Ventilation
3.1.6 Equipment And Utensils
2. Equipment shall be designed, constructed, installed, operated, and maintained so as not to pose a contamination threat to food sector packaging and to allow for cleaning beneath and behind it. Tools, utensils, and containers used for handling raw materials or packaging, work-in-progress, and food sector packaging shall be made of foodsafe materials.
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4. Non-conforming equipment shall be identified, tagged, and 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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3.1.7 Grounds And Roadways
1. The external grounds and areas surrounding the premises, including external storage buildings, machinery, and equipment shall be maintained to prevent accumulated debris and waste and control vegetation. These areas shall be inspected routinely to ensure they will not 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 food safety hazard to the operation of the premises. They shall be adequately drained to prevent pooling of water. Drains shall be separate from the site drainage system and regularly cleared of debris.
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3.2.1 Repairs And Maintenance
2. Routine maintenance of the equipment in any food sector packaging manufacturing, handling, or storage area shall be performed according to a maintenance control schedule and recorded. The maintenance schedule shall include the building, equipment, vehicles, and other areas of the premises critical to the maintenance of food safety.
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5. The maintenance supervisor and the site supervisor shall be informed if any repairs or maintenance pose a potential threat to food safety from foreign objects or contaminants (e.g., pieces of electrical wire, damaged light fittings, and loose overhead fittings). When possible, maintenance is to be conducted outside manufacturing 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 in the cleaning program. There shall be a plan in place to address completion of temporary repairs to ensure they do not become permanent solutions.
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7. Equipment located over raw or packaging materials, food sector packaging, or product conveyors shall be lubricated with food grade lubricants and their use controlled to minimize the contamination of the product. Machinery lubricant controls shall be in place to prevent contamination of food sector packaging from gear box oils, bearing lubricants, hydraulics, or any other source.
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3.2.2 Maintenance Staff And Contractors
3. Maintenance staff and contractors shall remove all tools, parts, and debris from areas where maintenance and repairs were conducted once it has been completed. They shall inform the appropriate supervisor so that hygiene and sanitation actions and a pre-operational inspection can be conducted prior to the restarting of operations.
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3.2.3 Calibration
1. The methods and responsibility for calibration and re-calibration of measuring, testing, 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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3.2.4 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; ii. Record pest sightings and trend the frequency of pest activity to target pesticide applications; iii. Outline the methods used to prevent pest problems; iv. Outline the pest elimination methods and the appropriate documentation for each inspection; v. Outline the frequency with which pest status is to be checked; vi. Include on a site map the identification, location, number, and type of applied pest control/ monitoring devices; vii. List the chemicals used. The chemicals are required to be approved by the relevant authority and their Safety Data Sheets (SDS) made available; 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; ix. Outline the requirements for staff awareness and training in the use of pest and vermin control chemicals and baits; and x. Measure the effectiveness of the program to verify the elimination of applicable pests and identify trends.
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2. Pest contractors and/or internal pest controllers shall: i. Be licensed and approved by the local relevant authority; ii. Use only trained and qualified operators who comply with regulatory requirements; iii. Use only approved chemicals; iv. Provide a pest prevention plan (refer to 2.3.2.7) that includes a site map indicating the location of bait stations, traps, and other applicable pest control monitoring devices; v. Report to a responsible authorized person on entering the premises and after the completion of inspections or treatments; vi. Provide regular inspections for pest activity with appropriate action taken if pests are present; and vii. Provide a written report of their findings and the inspections and treatments applied.
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3. Pest activity risks shall be analyzed and recorded. Inspections for pest activity shall be undertaken 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 raw materials or food sector packaging. Records of all pest control inspections and applications shall be maintained.
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3.2.5 Cleaning And Sanitation
4. Pre-operational inspections shall be conducted following cleaning and sanitation operations to ensure manufacturing areas, product contact surfaces, equipment, staff amenities, and other essential areas are clean before the start of production. Inspections shall be conducted by qualified personnel to ensure the areas are cleaned at a defined frequency.
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5. 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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6. Appropriate cleaning agents shall be purchased in accordance with applicable legislation and suitable for use. The site shall ensure that only trained staff handle cleaning agents and that it is according to manufacturer instructions. Documentation, storage, usage, and disposal of cleaning agents shall comply with 13.6.2.
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3.3.1 Personnel Welfare
2. The site shall have measures in place to prevent contact of raw and packaging materials, work-in-progress, food sector packaging, and product contact surfaces from any bodily fluids, open wounds, coughing, sneezing, spitting, or any other means. In the event of an injury that causes spillage of bodily fluid, a properly trained employee shall ensure that all affected areas have been adequately cleaned and that all affected materials have been quarantined and/or disposed of.
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3. Personnel with exposed cuts, sores, or lesions shall not engage in handling raw and packaging materials, work-in-progress, food sector packaging, and product contact surfaces. Minor cuts or abrasions on exposed parts of the body shall be covered with a colored bandage containing a metal-detectable strip or an alternative suitable waterproof and colored dressing.
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3.3.2 Handwashing
1. Personnel shall have clean hands, and hands shall be washed by all personnel, including staff, contractors, and visitors: i. On entering production areas; ii. After each visit to a toilet; iii. After using a handkerchief; iv. After smoking, eating, or drinking; and v. After handling waste or chemicals.
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3. Handwash stations shall have: i. Basins constructed of stainless steel or similar non-corrosive material; ii. A potable water supply at an appropriate temperature; iii. Liquid hand soap within a fixed dispenser; iv. Paper towels or effective hand dryer; and v. A means of containing used paper towels.
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4. Signage in appropriate languages instructing people to wash their hands before entering the food sector packaging manufacturing, handling, and storage areas shall be provided in a prominent position in break rooms, at break rooms exits, toilet rooms, and in outside eating areas if applicable.
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3.3.4 Visitors
1. All visitors shall be trained in, and comply with, applicable food safety and hygiene procedures before entering food sector packaging manufacturing, handling, or storage areas. Visitors shall be trained in, and comply with, additional food safety policies, such as maintenance and cleaning procedures, as appropriate to the purpose of the visit. Where applicable, policies shall define exceptions for visitors when they are escorted at all times.
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3.3.5 Staff Amenities (change Rooms, Toilets, Break Rooms)
2. Where applicable, facilities shall be provided to enable staff to change into and out of protective clothing as required. Provision shall be made for staff to store their street clothing and personal items separate from food sector packaging manufacturing, handling, or storage areas.
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3. Toilet rooms shall be: i. Designed and constructed so that they are separate from any food sector packaging manufacturing, handling, or storage areas; ii. Accessed from operations via an airlock vented to the exterior or through an adjoining room; iii. Sufficient in number for the maximum number of staff; iv. Constructed so that they can be easily cleaned and maintained; v. Include an area inside or nearby for storing protective clothing, outer garments, and other items while using the facilities; and vi. Kept clean and tidy. Tools/equipment used for cleaning toilet rooms shall not be used to clean food sector packaging manufacturing areas.
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3.4.1 Staff Engaged In Food Handling And Processing Operations
1. All personnel engaged in food sector packaging manufacture, handling, and storage operations shall comply with the following practices: i. Personnel entry to production areas shall be through designated access doors only; ii. All doors are to be kept closed. Doors shall not be left open for extended periods when access is required for waste removal or receiving of product/ingredient/packaging; iii. Raw and packaging materials, work-in-progress, and food sector packaging shall be maintained appropriately, kept off the floor when applicable, and handled and stored in a manner to prevent damage and contamination; and iv. Waste shall be contained in the bins identified for this purpose and removed from the manufacturing area on a regular basis and not left to accumulate.
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2. Personnel working in or visiting food sector packaging manufacturing, handling, or storage operations shall ensure that: i. Eating, drinking, smoking, or spitting is not permitted in areas where food sector packaging is manufactured, handled, stored, or exposed. ii. Drinking water is permitted in food sector packaging manufacturing, handling, and storage areas in a method that will not cause a food safety risk to raw and packaging materials, workin-progress, food sector packaging, and equipment.
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3.5.1 Water Supply
3. The use of non-potable water shall be controlled such that: i. There is no cross-contamination between potable and non-potable water lines; ii. Non-potable water piping and outlets are clearly identified; and iii. Hoses, taps, and other similar sources of possible contamination are designed to prevent back flow or back siphonage.
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3.5.2 Water Quality
1. Water shall comply with local, national, or internationally recognized potable water microbiological and quality standards as required when used for: i. Handwashing; ii. As a raw material or processing aid; iii. Cleaning of product contact surfaces and equipment; or iv. The manufacture of steam that will come into contact with food sector packaging or used to heat water that will come into contact with food sector packaging.
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2. Microbiological analysis of the water supply shall be conducted to verify the cleanliness of the supply, the monitoring activities, and the effectiveness of the treatment measures implemented. Samples for analysis shall be taken on-site at sources supplying water for the process, handwashing, and/or cleaning, or from within the site. The frequency of analysis shall be risk-based and at a minimum annually.
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3.5.3 Air And Other Gases
2. Compressed air and other systems used to store or dispense gases that come into contact with food sector packaging or product contact surfaces shall be maintained and regularly monitored for quality and potential food safety hazards. The frequency of analysis shall be risk-based and at a minimum annually.
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3.6.1 Storage Of Materials And Product
4. Where raw and packaging materials, work-in-progress, and food sector packaging are held under temporary or overflow conditions that are not designed for the safe storage of those goods, a risk analysis shall be performed to ensure the integrity of those goods is maintained, they are not at risk of contamination, and there are no other food safety concerns.
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3.6.2 Storage And Use Of Hazardous Chemicals And Toxic Substances
1. Hazardous chemicals and toxic substances, including solvents and agents with the potential for contamination of food sector packaging, shall be: i. Clearly labelled, identifying and matching the contents with their containers; ii. Included in a current list of all chemicals and toxic substances that are stored on-site; and iii. Supplemented with a current Safety Data Sheet (SDS) that is made available to all staff.
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2. Storage of hazardous chemicals and toxic substances shall be: i. Located in an area with appropriate signage indicating that the area is for hazardous storage; ii. Controlled, lockable, and accessible only by personnel trained in the storage and use of chemicals; iii. Adequately ventilated; iv. Stored where intended and not comingled (e.g., food versus non-food grade); v. Designed such that there is no cross-contamination between chemicals; and vi. Stored in a manner that prevents hazards to raw and packaging materials, work-in-progress, food sector packaging, and product contact surfaces.
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3. Hazardous chemicals and toxic substances shall be correctly labeled and: i. Used only according to manufacturers’ instructions; ii. Controlled to prevent contamination or a hazard to raw and packaging material, work-in-progress, food sector packaging, or finished product contact surfaces; iii. Returned to the appropriate storage areas after use; and iv. Be compliant with national and local legislation.
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4. Employees who handle hazardous chemicals and toxic substances, including pesticides and cleaning chemicals, shall: i. Be properly trained on handling and usage; ii. Be provided with first aid equipment and personnel protective equipment; and iii. Ensure compliance to the proper identification, storage, usage, disposal, and clean-up requirements as defined.
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5. The site shall dispose of obsolete inventory and empty containers of chemicals, pesticides, and toxic substances in accordance with site and regulatory requirements and ensure that: i. Single-use containers are not reused; ii. Containers are segregated and securely stored prior to collection; and iii. Containers are disposed through an appropriate vendor.
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3.6.3 Loading, Transport, And Unloading Practices
1. The practices applied during transport, loading, and unloading of raw and packaging materials and food sector packaging shall be documented and implemented. Practices shall be conducted to prevent cross-contamination, maintain appropriate storage conditions, and ensure product integrity.
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2. Vehicles (e.g., semi-trucks, trailers, vans, containers) used for transporting food sector packaging shall be inspected prior to loading to ensure they are clean, in good repair, suitable for the purpose, and free from odors or other conditions that may impact negatively on the food sector packaging.
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1.1.1 General Information
3.7.1 Control Of Foreign Matter Contamination
3. Containers, storage and transport vessels, equipment, utensils, and tools made of glass, porcelain, ceramics, and brittle plastics shall not be permitted in food sector packaging manufacturing, handling, and storage areas. Exceptions shall include product made from, or packaged in these materials, measurement instruments with glass dial covers or MIG thermometers required under regulation or part of the processing equipment, and other essential items shielded with shatterproof coverings.
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4. Glass, porcelain, ceramics, and brittle plastics that are permitted in manufacturing areas shall be listed on a glass inventory and inspected at a frequency based on risk to confirm that they have not been damaged or to monitor for further damage prior to repair or replacement. Regular inspections of product handling/contact zones shall be conducted (refer to 2.5.4.3) to ensure they are free of glass or similar material and to establish changes to the condition of objects listed in the glass inventory.
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7. Loose, deteriorated, or damaged objects on and above structures and equipment in food sector packaging manufacturing, handling, and storage areas shall be controlled, repaired, or replaced to prevent foreign object contamination and other food safety hazards affecting raw and packaging materials, work-in-progress, and food sector packaging.
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8. Knives and cutting tools used in manufacturing operations shall be controlled, kept clean, and well maintained so as not to present a hazard to raw materials, work-in progress, or food sector packaging. Snap-off blades shall not be used in food sector packaging manufacturing, handling, or storage areas.
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3.7.2 Managing Foreign Matter Contamination Incidents
1. In circumstances where glass or similar brittle material breakage occurs, the affected area and equipment shall be isolated, cleaned, and thoroughly inspected prior to restarting operations. Utensils and equipment used for clean-up and footwear of those walking in the vicinity shall be inspected and cleaned if necessary.
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